FEDERAL REGISTER

Vol. 86 Wednesday No. 90 May 12, 2021

Pages 25943–26148

OFFICE OF THE FEDERAL REGISTER

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Contents Federal Register Vol. 86, No. 90

Wednesday, May 12, 2021

Agency for Healthcare Research and Quality Education Department NOTICES NOTICES Agency Information Collection Activities; Proposals, Agency Information Collection Activities; Proposals, Submissions, and Approvals, 26036–26039 Submissions, and Approvals: Early Childhood Longitudinal Study, Kindergarten Class Agricultural Marketing Service of 2023–24 Preschool Round Removal Change PROPOSED RULES Request, 26018 Increased Assessment Rate: Dried Prunes Produced in California, 25975–25977 Election Assistance Commission National Organic Program: NOTICES Origin of Livestock, 25961–25974 Charter Renewal: Federal Advisory Committee, 26018–26019 Agriculture Department See Agricultural Marketing Service Energy Department See Animal and Plant Health Inspection Service See Federal Energy Regulatory Commission

Alcohol, Tobacco, Firearms, and Explosives Bureau Environmental Protection Agency NOTICES RULES Agency Information Collection Activities; Proposals, Air Quality State Implementation Plans; Approvals and Submissions, and Approvals: Promulgations: Explosives Employee Possessor Questionnaire, 26069– Michigan; Part 18 and Part 19 Revisions, 25954–25956 26070 Pennsylvania; Regulatory Updates to Nonattainment New Source Review Permitting Requirements for 2012 Animal and Plant Health Inspection Service Fine Particulate Matter National Ambient Air Quality NOTICES Standard, 25951–25953 Pest Risk Analysis: Exemption from the Requirement of a Tolerance: Importation of Fresh Mango Fruit from Colombia Into the Sodium lauroyl sarcosinate, 25956–25960 United States, 25998–25999 PROPOSED RULES Air Quality State Implementation Plans; Approvals and Promulgations: Centers for Medicare & Medicaid Services Michigan; Part 18 and Part 19 Revisions, 25978 NOTICES NOTICES Agency Information Collection Activities; Proposals, National Pollutant Discharge Elimination System: Submissions, and Approvals: 2022 Issuance of General Permit for Stormwater Medicaid and Children’s Health Insurance Program, Discharges from Construction Activities, 26023– 26042–26043 26033 Request for Nominations: Privacy Act; Systems of Records, 26033–26035 Advisory Panel on Outreach and Education, 26039–26042 Federal Aviation Administration Coast Guard NOTICES RULES Intent to Rule on Request to Dispose 10.3 Acres of Land at Safety Zone: Dillant-Hopkins Airport, Swanzey, NH, 26126–26127 Pierce County Ferry Steilacoom II, Puget Sound, WA, 25949–25951 Federal Communications Commission PROPOSED RULES Commerce Department Television Broadcasting Services: See Economic Analysis Bureau Medford, Oregon, 25979–25980 See International Trade Administration Redding, CA, 25978–25979 See National Oceanic and Atmospheric Administration NOTICES See Patent and Trademark Office Agency Information Collection Activities; Proposals, Submissions, and Approvals, 26035–26036 Drug Enforcement Administration NOTICES Federal Energy Regulatory Commission Bulk Manufacturer of Controlled Substances Application: NOTICES Patheon API Manufacturing, Inc., 26070–26071 Agency Information Collection Activities; Proposals, Submissions, and Approvals, 26019–26020, 26022– Economic Analysis Bureau 26023 NOTICES Combined Filings, 26020–26022 Request for Nominations: Complaint: Federal Economic Statistics Advisory Committee, 25999– Spire Marketing Inc. v. Panhandle Eastern Pipe Line 26000 Company, LP, 26020

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Federal Railroad Administration Interior Department NOTICES See Fish and Wildlife Service Petition for Waiver of Compliance, 26127–26128 International Trade Administration Federal Reserve System NOTICES NOTICES Antidumping or Countervailing Duty Investigations, Orders, Change in Bank Control: or Reviews: Acquisitions of Shares of a Bank or Bank Holding Boltless Steel Shelving Units Prepackaged for Sale from Company, 26036 the People’s Republic of China, 26000–26001 Lightweight Thermal Paper from the People’s Republic of Fish and Wildlife Service China, 26009–26010 Determination of Sales at Less Than Fair Value: NOTICES Thermal Paper from Germany, 26001–26003 Endangered and Threatened Wildlife and Plants: Thermal Paper from Japan, 26011–26013 Draft Habitat Conservation Plan and Draft Categorical Thermal Paper from Spain, 26003–26006 Exclusion for the Santa Barbara County Distinct Thermal Paper from the Republic of Korea, 26007–26009 Population Segment of the California Tiger Quarterly Update: Salamander; Orcutt Hill Resource and Solar Project, Annual Listing of Foreign Government Subsidies on Pacific Coast Energy Company, Santa Barbara Articles of Cheese Subject to an In-Quota Rate of County, CA, 26063 Duty, 26010–26011 Draft Recovery Plan for the Rufa Red Knot, 26062–26063 Request for Applications: President’s Advisory Council on Doing Business in Food and Drug Administration Africa, 26006–26007 NOTICES Agency Information Collection Activities; Proposals, International Trade Commission Submissions, and Approvals: NOTICES State Enforcement Notifications, 26046–26047 Complaint: Guidance: Certain Electrolyte Containing Beverages and Labeling COVID–19: Developing Drugs and Biological Products for and Packaging Thereof, 26066–26067 Treatment or Prevention, 26050–26052 Investigations; Determinations, Modifications, and Rulings, E9(R1) Statistical Principles for Clinical Trials: etc.: Addendum: Estimands and Sensitivity Analysis in Certain Botulinum Toxin Products, Processes for Clinical Trials; International Council for Manufacturing or Relating to Same and Certain Harmonisation, 26047–26048 Products Containing Same; Return of Bond, 26068– M9 Biopharmaceutics Classification System-Based 26069 Biowaivers; International Council for Harmonisation, Certain Collapsible and Portable Furniture, 26069 26054–26056 Cut-to-Length Carbon Steel Plate from China, Russia, and Q12 Technical and Regulatory Considerations for Ukraine, 26067–26068 Pharmaceutical Product Lifecycle Management; Foreign Censorship Part 1: Policies and Practices International Council for Harmonisation, 26043– Affecting U.S. Businesses and Investigation No. 332– 26045 586: Foreign Censorship Part 2: Trade and Economic Q3D(R2)—Guideline for Elemental Impurities; Effects on U.S. Businesses, 26064–26066 International Council for Harmonisation, 26052– 26054 Justice Department Qualified Infectious Disease Product Designation— See Alcohol, Tobacco, Firearms, and Explosives Bureau Questions and Answers, 26045–26046 See Drug Enforcement Administration S11 Nonclinical Safety Testing in Support of Management and Budget Office Development of Pediatric Pharmaceuticals; International Council for Harmonisation, 26056– NOTICES Designation of Databases for Treasury’s Working System 26058 under the Do Not Pay Initiative, 26071 S5(R3) Detection of Reproductive and Developmental Toxicity for Human Pharmaceuticals; International National Highway Traffic Safety Administration Council for Harmonisation, 26048–26050 PROPOSED RULES Withdrawal of Approval of New Drug Applications: Corporate Average Fuel Economy Preemption, 25980–25992 Lederle Laboratories et al., 26058–26059 NOTICES Agency Information Collection Activities; Proposals, Health and Human Services Department Submissions, and Approvals: See Agency for Healthcare Research and Quality Consolidated Vehicles’ Owner’s Manual Requirements for See Centers for Medicare & Medicaid Services Motor Vehicles and Motor Vehicle Equipment, See Food and Drug Administration 26128–26133 See National Institutes of Health Motorcycle Helmets (Labeling), 26136–26137 NOTICES Petition for Exemption from the Federal Motor Vehicle Meetings: Theft Prevention Standard: Presidential Advisory Council on Combating Antibiotic– Mazda Motor Corp., 26137–26140 Resistant Bacteria, 26059 Toyota Motor North America, Inc., 26133–26136 Petition for Exemption from the Federal Motor Vehicle Homeland Security Department Theft Prevention Standard: See Coast Guard North American Subaru, Inc., 26140–26143

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National Institutes of Health EXECUTIVE ORDERS NOTICES Committees; Establishment, Renewal, Termination, etc.: Meetings: Climate Change Support Office; Establishment (EO Center for Scientific Review, 26061–26062 14027), 25947–25948 National Cancer Institute, 26060–26061 National Center for Advancing Translational Sciences, Securities and Exchange Commission 26060 NOTICES National Institute of Mental Health, 26059–26060 Self-Regulatory Organizations; Proposed Rule Changes: Cboe EDGA Exchange, Inc., 26113–26115 National Oceanic and Atmospheric Administration DTCC Data Repository (U.S.), LLC, 26115–26124 PROPOSED RULES Financial Industry Regulatory Authority, Inc., 26084– Atlantic Highly Migratory Species: 26109 General Category Restricted-Fishing Days, 25992–25997 MIAX Emerald, LLC, 26111–26112 NOTICES National Securities Clearing Corp., 26112–26113 Agency Information Collection Activities; Proposals, New York Stock Exchange, LLC, 26110 Submissions, and Approvals: New York Stock Exchange, LLC, NYSE American, LLC, Protocol for Access to Tissue Specimen Samples from the NYSE Arca, Inc., et al., 26082–26084 National Marine Mammal Tissue Bank, 26014 NYSE Arca, Inc., 26073–26081, 26110 United States Pacific Highly Migratory Species Hook and Line Logbook, 26014–26015 Susquehanna River Basin Commission Permits: NOTICES Marine Mammals and Endangered Species, 26013–26014 Grandfathering Registration, 26126 Meetings, 26126 National Science Foundation Projects Approved: NOTICES Consumptive Uses of Water, 26124–26125 Meetings: Committee on Equal Opportunities in Science and Transportation Department Engineering, 26071 See Federal Aviation Administration See Federal Railroad Administration Nuclear Regulatory Commission See National Highway Traffic Safety Administration PROPOSED RULES American Society of Mechanical Engineers 2019–2020 Code Veterans Affairs Department Editions; Correction, 25977–25978 NOTICES NOTICES Agency Information Collection Activities; Proposals, Meetings; Sunshine Act, 26071–26072 Submissions, and Approvals: Certification of School Attendance or Termination, 26143 Patent and Trademark Office NOTICES Agency Information Collection Activities; Proposals, Separate Parts In This Issue Submissions, and Approvals: Trademark Post Registration, 26015–26018 Part II Postal Regulatory Commission Presidential Documents, 26145–26148 NOTICES New Postal Products, 26072–26073 Reader Aids Presidential Documents Consult the Reader Aids section at the end of this issue for PROCLAMATIONS phone numbers, online resources, finding aids, and notice Special Observances: of recently enacted public laws. Mother’s Day (Proc. 10207), 26145–26148 To subscribe to the Federal Register Table of Contents National Hurricane Preparedness Week (Proc. 10205), electronic mailing list, go to https://public.govdelivery.com/ 25943–25944 accounts/USGPOOFR/subscriber/new, enter your e-mail National Women’s Health Week (Proc. 10206), 25945– address, then follow the instructions to join, leave, or 25946 manage your subscription.

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CFR PARTS AFFECTED IN THIS ISSUE

A cumulative list of the parts affected this month can be found in the Reader Aids section at the end of this issue.

3 CFR Proclamations: 10205...... 25943 10206...... 25945 10207...... 26147 Executive Orders: 14027...... 25947 7 CFR Proposed Rules: 205...... 25961 993...... 25975 10 CFR Proposed Rules: 50...... 25977 33 CFR 165...... 25949 40 CFR 52 (2 documents) ...... 25951, 25954 180...... 25956 Proposed Rules: 52...... 25978 47 CFR Proposed Rules: 73 (2 documents) ...... 25978, 25979 49 CFR Proposed Rules: 531...... 25980 533...... 25980 50 CFR Proposed Rules: 635...... 25992

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Federal Register Presidential Documents Vol. 86, No. 90

Wednesday, May 12, 2021

Title 3— Proclamation 10205 of May 7, 2021

The President National Hurricane Preparedness Week, 2021

By the President of the United States of America

A Proclamation In 2020, the United States experienced a record year for extreme weather, with an unprecedented 30 named storms in the Atlantic Basin alone. Twelve of these storms, six of which were hurricanes, made landfall in the United States. These storms and hurricanes unleashed their devastating power on the individuals and communities in their paths. Their frequency and impact also highlight the existential threat posed to our Nation by climate change. During National Hurricane Preparedness Week, we encourage all Americans living in potentially affected areas to take precautions to ensure that they, their families, and their communities are best prepared for hurricanes, and commit to improving our resilience to climate-related catastrophes. The costs exacted by these storms, in lives, livelihoods, and property damage, are staggering. Seven of last year’s 30 named storms claimed 86 lives and caused $40 billion dollars in damage. Over the past two decades, tropical storms and hurricanes have taken over 6,000 lives in the United States and caused $853 billion in damage. These storms accounted for 60 percent of the costs of our most damaging weather events. In addition to the highly- visible damage, hurricanes also exact an unseen and long-lasting emotional toll; the trauma of a lost loved one, the sadness of losing treasured posses- sions, the stress of a financial setback. This is compounded for low-income communities and communities of color who are more likely to live in areas that make them vulnerable to flooding and other climate-related weather events, and less likely to have the funds to prepare for and recover from extreme weather events. As changes in our climate lead to additional extreme weather events, we must pursue research and resilience policies that keep us safe and strengthen our resilience. Since taking office, I have directed my Administration to put the climate crisis and the communities most vulnerable to it at the center of our domestic and foreign policy. This includes investing in weather forecasting and climate research to bolster our understanding of how our changing climate is altering the behavior of hurricanes, as well as ensuring every community has the resources to prepare for and respond to these changing storms. Although hurricanes cannot be prevented, we can predict and prepare for them. We are constantly improving our forecasts and communications with the public about the dangers posed by hurricanes. National Oceanic and Atmos- pheric Administration (NOAA) forecasters work around the clock and col- laborate with State, local, Tribal, and territorial emergency managers and government officials to provide actionable information before, during, and after a hurricane. NOAA also collaborates with key decision makers in Federal agencies, including the Department of Homeland Security and the Federal Emergency Management Agency (FEMA). Such collaborative work ensures that communities standing in a storm’s path have the information and resources they need to adequately prepare. After the storm, NOAA provides stakeholders with essential information for damage assessments and to re-open ports and coastal waterways critical to our Nation’s commerce.

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In addition to work being done by Federal, State, local, and Tribal govern- ments, Americans should prepare themselves before a hurricane hits. Keep up with weather forecasts and have an evacuation kit prepared in case you ever need to relocate in advance of a hurricane. More information and preparedness plan templates are available from FEMA’s ready.gov website. Everyone has a role to play in hurricane preparedness and making us a Weather-Ready Nation. When hurricanes strike, that’s how we will save lives, lessen the damage to our homes, communities, and infrastructure, and recover stronger and faster. NOW, THEREFORE, I, JOSEPH R. BIDEN JR., President of the United States of America, by virtue of the authority vested in me by the Constitution and the laws of the United States, do hereby proclaim May 9 through May 15, 2021, as National Hurricane Preparedness Week. I urge all Americans to help build our Weather-Ready Nation, so that individuals are empowered and organizations can fulfill leadership roles in their communities. I call on our Federal, State, Tribal, territorial and local government agencies to share information that will protect lives and property. IN WITNESS WHEREOF, I have hereunto set my hand this seventh day of May, in the year of our Lord two thousand twenty-one, and of the Independence of the United States of America the two hundred and forty- fifth.

[FR Doc. 2021–10128 Filed 5–11–21; 8:45 am] Billing code 3295–F1–P

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Proclamation 10206 of May 7, 2021

National Women’s Health Week, 2021

By the President of the United States of America

A Proclamation It’s a simple proposition for me: women are entitled to the same rights and opportunities as men, including access to high-quality, affordable health care. National Women’s Health Week is an opportunity to focus on the work we need to do as a Nation to ensure equal access to high-quality, affordable care for women, and to build a more prosperous, healthy future for all. This starts by strengthening the Affordable Care Act, which ensures that women cannot be denied coverage for pre-existing conditions, such as preg- nancy, or charged more for coverage simply because they are women. The Affordable Care Act also expanded coverage to millions of women who were previously uninsured, and made various preventive services available free of charge, including Pap smears and mammograms. In addition, it covers screening and counseling for domestic and intimate partner violence. To cover more Americans, the Biden-Harris Administration began a special open enrollment period on healthcare.gov, so that women who are uninsured have the opportunity to sign up for coverage through August 15. And, we are committed to building on the successes of this law to make coverage more affordable. The American Rescue Plan, enacted earlier this year, will save women buying coverage on their own $50 per month on their health care premiums. The theme of this year’s National Women’s Health Week is ‘‘Ending the Pandemic and Elevating Women’s Health.’’ The quickest and most effective way to defeat this pandemic and restore public health is through vaccination. My Administration is committed to advancing women’s health and ensuring an equitable response to the COVID–19 pandemic. We have prioritized and increased access to the COVID–19 vaccine and expanded the criteria for eligibility to include all adults over the age of 16. We encourage women to talk to their doctors, nurses, nurse practitioners, or physician assistants about the COVID–19 vaccine. And, it is important for women and girls to catch up on any missed vaccines or medical care from this past year. Delays in routine care—such as Pap smears, mammograms, bone density scans, stress tests, cholesterol screenings, blood pressure screenings, physical exams, general check-ups and other preventive health screenings—can cause many conditions to go undetected. As we mark National Women’s Health Week, let us make sure that all women and girls, particularly those with underlying health conditions such as hypertension, diabetes, cardiovascular and respiratory conditions, and mental health needs, can prioritize their own health. The COVID–19 pandemic has further revealed why the unique needs of women and girls must be centered in our health care system, and further brought to light the health disparities and systemic biases that women, particularly women of color, continue to face, including inequitable maternity care and access to reproductive health care.

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My Administration aims to address persistent and unconscionable disparities in maternal health outcomes. Pregnancy-related mortality for Black and Amer- ican Indian and Alaska Native women is two to three times higher than for white, Hispanic, and Asian American and Pacific Islander women. Ensur- ing that all women have equitable access to health care before, during, and after pregnancy is essential. I am committed to building a health care system that delivers equity and dignity to all women and girls. In addition, we must protect access to sexual and reproductive health care, including the broad range of family planning services. As we strive to improve the health of our Nation, we must prioritize the health and well-being of our women and girls. During National Women’s Health Week, we reaffirm our commitment to this important work. NOW, THEREFORE, I, JOSEPH R. BIDEN JR., President of the United States of America, by virtue of the authority vested in me by the Constitution and the laws of the United States, do hereby proclaim May 9 through May 15, 2021, as National Women’s Health Week. During this week, I encourage all Americans to dedicate themselves to the work of improving the health of women and girls and promoting health equity for all. IN WITNESS WHEREOF, I have hereunto set my hand this seventh day of May, in the year of our Lord two thousand twenty-one, and of the Independence of the United States of America the two hundred and forty- fifth.

[FR Doc. 2021–10130 Filed 5–11–21; 8:45 am] Billing code 3295–F1–P

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Executive Order 14027 of May 7, 2021

Establishment of the Climate Change Support Office

By the authority vested in me as President by the Constitution and the laws of the United States of America, including section 202 of the Revised Statutes (22 U.S.C. 2656) and section 3161 of title 5, United States Code, it is hereby ordered as follows: Section 1. Establishment of the Climate Change Support Office. (a) There is established within the Department of State, in accordance with section 3161 of title 5, United States Code, a temporary organization to be known as the Climate Change Support Office (CCSO). (b) The CCSO shall be headed by a Director selected by the Secretary of State (Secretary). In addition to a Director, the CCSO may be staffed by persons in such numbers and with such skills as are necessary for the performance of CCSO functions. (c) The purpose of the CCSO shall be to perform the specific project of supporting bilateral and multilateral engagement to advance the United States initiative to address the global climate crisis, led by the Department of State and in coordination with other executive departments and agencies, consistent with Executive Order 14008 of January 27, 2021 (Tackling the Climate Crisis at Home and Abroad). The CCSO shall support the Department of State, including the Special Presidential Envoy for Climate, in United States efforts to elevate and underscore the commitment my Administration will make towards addressing the global climate crisis. (d) In carrying out its purpose as set forth in subsection 1(c) of this order, the CCSO shall: (i) support the Department of State and other executive departments and agencies, as appropriate, in leading diplomatic engagement on climate change, exercising climate leadership in international fora, increasing inter- national climate ambition, and ensuring that climate change is integrated into all elements of United States foreign policy-making decision processes; (ii) support efforts that go beyond the climate work currently carried out by the Department of State across a wide range of international fora that address clean energy, aviation, shipping, the Artic, the ocean, sustain- able development, and migration; and (iii) perform such other functions related to the specific project set forth in subsection 1(c) of this order as the Secretary may assign. (e) The CCSO shall terminate at the end of the maximum period permitted by section 3161(a)(1) of title 5, United States Code, unless sooner terminated by the Secretary. Sec. 2. General Provisions. (a) Nothing in this order shall be construed to impair or otherwise affect: (i) the authority granted by law to an executive department or agency or the head thereof; or (ii) the functions of the Director of the Office of Management and Budget relating to budgetary, administrative, or legislative proposals. (b) This order shall be implemented consistent with applicable law and subject to the availability of appropriations.

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(c) This order is not intended to, and does not, create any right or benefit, substantive or procedural, enforceable at law or in equity by any party against the United States, its departments, agencies, or entities, its officers, employees, or agents, or any other person.

THE WHITE HOUSE, May 7, 2021.

[FR Doc. 2021–10139 Filed 5–11–21; 8:45 am] Billing code 3295–F1–P

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Rules and Regulations Federal Register Vol. 86, No. 90

Wednesday, May 12, 2021

This section of the FEDERAL REGISTER COTP Captain of the Port exercise participants. This rule is contains regulatory documents having general DHS Department of Homeland Security needed to protect personnel, vessels, applicability and legal effect, most of which FR Federal Register and the marine environment in the are keyed to and codified in the Code of NPRM Notice of proposed rulemaking navigable waters within the moving Federal Regulations, which is published under § Section safety zone. 50 titles pursuant to 44 U.S.C. 1510. U.S.C. United States Code IV. Discussion of the Rule The Code of Federal Regulations is sold by II. Background Information and the Superintendent of Documents. Regulatory History This rule establishes a moving safety zone from 8:30 a.m. until 2:30 p.m. on The Coast Guard is issuing this May 13, 2021. The moving safety zone temporary rule without prior notice and DEPARTMENT OF HOMELAND will cover all navigable waters within opportunity to comment pursuant to SECURITY 1,000 yards of Pierce County ferry authority under section 4(a) of the Steilacoom II. Part of this exercise Administrative Procedure Act (APA) (5 Coast Guard includes the use of high speed Coast U.S.C. 553(b)). This provision Guard and law enforcement vessel 33 CFR Part 165 authorizes an agency to issue a rule maneuvers and the use of blank fire without prior notice and opportunity to [Docket Number USCG–2021–0313] ammunition. The duration of the zone is comment when the agency for good intended to protect mariners from the RIN 1625–AA00 cause finds that those procedures are hazards associated with military ‘‘impracticable, unnecessary, or contrary training operations. No vessel or person Safety Zone; Pierce County Ferry to the public interest.’’ Under 5 U.S.C. will be permitted to enter the safety Steilacoom II, Puget Sound, WA 553(b)(B), the Coast Guard finds that zone without obtaining permission from good cause exists for not publishing a AGENCY: Coast Guard, DHS. the COTP or a designated notice of proposed rulemaking (NPRM) representative. As used in this section, ACTION: Temporary final rule. with respect to this rule because it is a designated representative means a impracticable. The Coast Guard was SUMMARY: The Coast Guard is Coast Guard Patrol Commander, notified of the military exercise on April including a Coast Guard coxswain, petty establishing a temporary moving safety 7, 2021, and due to the evolving zone for navigable waters within a officer, or other officer operating a Coast dynamic nature of the on-the-water Guard vessel and a Federal, State, and 1,000-yard radius around the Pierce exercise it was determined on May 4, County ferry Steilacoom II. The safety local officer designated by or assisting 2021, that immediate action is needed to the Captain of the Port Puget Sound zone is needed to protect personnel, respond to the potential safety hazards vessels, and the marine environment (COTP) in the enforcement of the safety associated with the exercise. The COTP zone. from potential hazards created by the determined this regulation is necessary on-the-water military exercise. Entry of to ensure the safety of the public. The V. Regulatory Analyses vessels or persons into this zone is Coast Guard lacks sufficient time to We developed this rule after prohibited unless specifically provide a reasonable comment period considering numerous statutes and authorized by the Captain of the Port and then consider those comments Executive orders related to rulemaking. Sector Puget Sound or a designated before issuing the rule. Below we summarize our analyses representative. Under 5 U.S.C. 553(d)(3), the Coast based on a number of these statutes and DATES: This rule is effective from 8:30 Guard finds that good cause exists for Executive orders, and we discuss First a.m. through 2:30 p.m. on May 13, 2021. making this rule effective less than 30 Amendment rights of protestors. days after publication in the Federal ADDRESSES: To view documents A. Regulatory Planning and Review mentioned in this preamble as being Register. Delaying the effective date of available in the docket, go to https:// this rule would be contrary to the public Executive Orders 12866 and 13563 www.regulations.gov, type USCG–2021– interest because this regulation is direct agencies to assess the costs and 0313 in the ‘‘SEARCH’’ box and click needed on May 13, 2021, less than 30 benefits of available regulatory ‘‘SEARCH.’’ Click on Open Docket days after the Coast Guard received final alternatives and, if regulation is Folder on the line associated with this details of the exercise, in order to ensure necessary, to select regulatory rule. safety of the public, mariners, and approaches that maximize net benefits. exercise participants. This rule has not been designated a FOR FURTHER INFORMATION CONTACT: If ‘‘significant regulatory action,’’ under you have questions on this rule, call or III. Legal Authority and Need for Rule Executive Order 12866. Accordingly, email Chief Warrant Officer William The Coast Guard is issuing this rule this rule has not been reviewed by the Martinez, Sector Puget Sound under authority in 46 U.S.C. 70034, Office of Management and Budget Waterways Management Division, U.S. (previously 33 U.S.C. 1231). The (OMB). Coast Guard; telephone 206–217–6051, Captain of the Port Puget Sector Sound This regulatory action determination email SectorPugetSoundWWM@ (COTP) has determined that potential is based on size, location, and duration uscg.mil. hazards associated with the on-the- of the safety zone. Vessel traffic will be SUPPLEMENTARY INFORMATION: water military exercise on May 13, 2021, able to safely transit around this safety will be a safety concern for anyone zone which would impact a small I. Table of Abbreviations within a 1,000-yard radius of the Pierce designated area of the Puget sound for CFR Code of Federal Regulations County ferry Steilacoom II and the a 6 hour period. The Coast Guard will

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transmit a Safety Marine Information C. Collection of Information Appendix A, Table 1 of DHS Instruction Broadcast to mariners via VHF–FM This rule will not call for a new Manual 023–01–001–01, Rev. 1. marine channel 16 regarding the safety collection of information under the G. Protest Activities zone enforcement and publish in the Paperwork Reduction Act of 1995 (44 The Coast Guard respects the First Local Notice to Mariners information U.S.C. 3501–3520). about details of the safety zone. In Amendment rights of protesters. addition, the rule allows mariners to D. Federalism and Indian Tribal Protesters are asked to call or email the seek permission to enter the zone. To Governments person listed in the FOR FURTHER INFORMATION CONTACT section to seek permission to enter, contact the A rule has implications for federalism coordinate protest activities so that your COTP or the COTP’s representative by under Executive Order 13132, message can be received without VHF Channel 16. Those in the safety Federalism, if it has a substantial direct jeopardizing the safety or security of zone must comply with all lawful orders effect on the States, on the relationship people, places or vessels. or directions given to them by the COTP between the National Government and or the COTP’s designated representative. the States, or on the distribution of List of Subjects in 33 CFR Part 165 B. Impact on Small Entities power and responsibilities among the Harbors, Marine safety, Navigation various levels of government. We have (water), Reporting and recordkeeping The Regulatory Flexibility Act of analyzed this rule under that Order and 1980, 5 U.S.C. 601–612, as amended, requirements, Security measures, have determined that it is consistent Waterways. requires Federal agencies to consider with the fundamental federalism For the reasons discussed in the the potential impact of regulations on principles and preemption requirements preamble, the Coast Guard amends 33 small entities during rulemaking. The described in Executive Order 13132. CFR part 165 as follows: term ‘‘small entities’’ comprises small Also, this rule does not have tribal businesses, not-for-profit organizations implications under Executive Order that are independently owned and PART 165—REGULATED NAVIGATION 13175, Consultation and Coordination AREAS AND LIMITED ACCESS AREAS operated and are not dominant in their with Indian Tribal Governments, fields, and governmental jurisdictions because it does not have a substantial ■ 1. The authority citation for part 165 with populations of less than 50,000. direct effect on one or more Indian continues to read as follows: The Coast Guard certifies under 5 U.S.C. tribes, on the relationship between the 605(b) that this rule will not have a Authority: 46 U.S.C. 70034, 70051; 33 CFR Federal Government and Indian tribes, 1.05–1, 6.04–1, 6.04–6, and 160.5; significant economic impact on a or on the distribution of power and substantial number of small entities. Department of Homeland Security Delegation responsibilities between the Federal No. 0170.1. While some owners or operators of Government and Indian tribes. vessels intending to transit the safety ■ 2. Add § 165.T13–0313 to read as zone may be small entities, for the E. Unfunded Mandates Reform Act follows: reasons stated in section V.A above, this The Unfunded Mandates Reform Act § 165.T13–0313 Safety Zone; Pierce rule will not have a significant of 1995 (2 U.S.C. 1531–1538) requires County Ferry Steilacoom II, Puget Sound, economic impact on any vessel owner Federal agencies to assess the effects of WA. or operator. their discretionary regulatory actions. In (a) Location. The following area is a Under section 213(a) of the Small particular, the Act addresses actions moving safety zone: All navigable Business Regulatory Enforcement that may result in the expenditure by a waters within a 1,000-yard radius Fairness Act of 1996 (Pub. L. 104–121), State, local, or tribal government, in the around the Pierce County ferry we want to assist small entities in aggregate, or by the private sector of Steilacoom II. understanding this rule. If the rule $100,000,000 (adjusted for inflation) or (b) Definitions. As used in this would affect your small business, more in any one year. Though this rule section, a designated representative organization, or governmental will not result in such an expenditure, means a Coast Guard Patrol jurisdiction and you have questions we do discuss the effects of this rule Commander, including a Coast Guard concerning its provisions or options for elsewhere in this preamble. coxswain, petty officer, or other officer compliance, please call or email the operating a Coast Guard vessel and a F. Environment person listed in the FOR FURTHER Federal, State, and local officer INFORMATION CONTACT section. We have analyzed this rule under designated by or assisting the Captain of Small businesses may send comments Department of Homeland Security the Port Sector Puget Sound (COTP) in on the actions of Federal employees Directive 023–01, Rev. 1, associated the enforcement of the safety zone. who enforce, or otherwise determine implementing instructions, and (c) Regulations. (1) Under the general compliance with, Federal regulations to Environmental Planning COMDTINST safety zone regulations in subpart C of the Small Business and Agriculture 5090.1 (series), which guide the Coast this part, you may not enter the safety Regulatory Enforcement Ombudsman Guard in complying with the National zone described in paragraph (a) of this and the Regional Small Business Environmental Policy Act of 1969 (42 section unless authorized by the COTP Regulatory Fairness Boards. The U.S.C. 4321–4370f), and have or the COTP’s designated representative. Ombudsman evaluates these actions determined that this action is one of a (2) To seek permission to enter, annually and rates each agency’s category of actions that do not contact the COTP or the COTP’s responsiveness to small business. If you individually or cumulatively have a representative by VHF Channel 16. wish to comment on actions by significant effect on the human Those in the safety zone must comply employees of the Coast Guard, call environment. This rule involves a with all lawful orders or directions 1–888–REG–FAIR (1–888–734–3247). moving safety zone lasting only 6 hours given to them by the COTP or the The Coast Guard will not retaliate that will prohibit entry within 1,000 COTP’s designated representative. against small entities that question or yards of Pierce County ferry Steilacoom (d) Enforcement period. This section complain about this rule or any policy II. It is categorically excluded from will be enforced from 8:30 a.m. to 2:30 or action of the Coast Guard. further review under paragraph L60 of p.m. on May 13, 2021.

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Dated: May 5, 2021. FOR FURTHER INFORMATION CONTACT: ‘‘Nonattainment New Source Review.’’ P.M. Hilbert, Amy Johansen, Permits Branch (3AD10), See CAA section 172(c)(5). Captain, U.S. Coast Guard, Captain of the Air & Radiation Division, U.S. PADEP’s SIP revision revises NNSR Port Sector Puget Sound. Environmental Protection Agency, permit requirements for major sources [FR Doc. 2021–10085 Filed 5–11–21; 8:45 am] Region III, 1650 Arch Street, of PM2.5. Specifically, PADEP’s 25 Pa. BILLING CODE 9110–04–P Philadelphia, Pennsylvania 19103. The Code Chapters 121 and 127 have been telephone number is (215) 814–2156. amended to implement additional Ms. Johansen can also be reached via provisions pertaining to PM2.5 ENVIRONMENTAL PROTECTION electronic mail at johansen.amy@ precursors, as promulgated in EPA’s AGENCY epa.gov. rule entitled Fine Particulate Matter SUPPLEMENTARY INFORMATION: National Ambient Air Quality 40 CFR Part 52 Standards: State Implementation Plan I. Background Requirements (2016 Implementation [EPA–R03–OAR–2020–0416; FRL–10023– Rule). 81 FR 58010 (August 24, 2016). 38–Region 3] On March 9, 2021 (86 FR 13511), EPA published a notice of proposed As required by EPA’s 2016 Implementation Rule, which Air Plan Approval; Pennsylvania; rulemaking (NPRM) for the implements the D.C. Circuit court’s Regulatory Updates to Nonattainment Commonwealth of Pennsylvania. In the January 2013 decision in NRDC v. EPA,3 New Source Review (NNSR) Permitting NPRM, EPA proposed approval of areas classified as nonattainment for any Requirements for 2012 Fine Particulate amendments to 25 Pa. Code Chapters 121 (General Provisions) and 127 PM2.5 NAAQS are required to comply Matter (PM2.5) National Ambient Air with the parts of CAA subpart 4 section Quality Standard (NAAQS) (Construction, Modification, Reactivation and Operation of Sources) 189(e) that require the control of major AGENCY: Environmental Protection to implement Federal NNSR provisions sources of PM10 precursors (and hence under the court decision, PM2.5 Agency (EPA). for the 2012 PM2.5 NAAQS. Specifically, precursors) ‘‘except where the ACTION: Final rule. the SIP revision establishes that emissions of volatile organic Administrator determines that such SUMMARY: The Environmental Protection compounds (VOC) and ammonia are sources do not contribute significantly to PM10 levels which exceed the Agency (EPA) is approving a state precursors to PM2.5 for new and standard in the area.’’ 4 The 2016 implementation plan (SIP) revision modified major sources emitting PM2.5 Implementation Rule amended the submitted by the Commonwealth of in nonattainment areas for PM2.5 in Pennsylvania, on March 10, 2020. This Pennsylvania; 1 establishes a significant definitions of (1) ‘‘regulated NSR pollutant’’ with regard to PM2.5 revision pertains to the Pennsylvania impact level for PM2.5; proposes Department of Environmental emission offset ratios for emissions of precursors; (2) ‘‘major stationary source’’ with regard to major sources of Protection’s (PADEP) amendments to 25 VOC and ammonia as PM2.5 precursors; Pa. Code Chapters 121 (General and amends relevant definitions. The direct PM2.5 emissions and PM2.5 Provisions) and 127 (Construction, formal SIP revision was submitted by precursors locating in PM2.5 Modification, Reactivation and PADEP on March 10, 2020. nonattainment areas classified as Operation of Sources) to implement EPA has revised the NAAQS for PM2.5 moderate and serious; and (3) Federal nonattainment new source on multiple occasions, most recently in ‘‘significant’’ with regard to emissions of review (NNSR) provisions for the 2012 2012. On December 14, 2012, the annual direct PM2.5 and its precursors. annual fine particulate matter (PM2.5) primary standard for PM2.5 was lowered II. Summary of SIP Revision and EPA national ambient air quality standard from 15 micrograms per meter cubed Analysis (NAAQS). EPA is approving these (mg/m3) to 12 mg/m3. See 78 FR 3087 revisions to the Pennsylvania SIP in (January 15, 2013). The existing 24-hour A. Summary of SIP Revision accordance with the requirements of the standards (primary and secondary) were 25 Pa. Code Chapters 121 and 127 Clean Air Act (CAA). retained at 35 mg/m3, as was the annual address NNSR permit requirements for 3 DATES: This final rule is effective on secondary standard of 15 mg/m . Upon major sources of PM2.5. PADEP’s SIP June 11, 2021. promulgation of the 2012 PM2.5 NAAQS, revision has been amended to EPA formally classified all of Delaware implement additional provisions ADDRESSES: EPA has established a County and Lebanon County, pertaining to precursors, as promulgated docket for this action under Docket ID Pennsylvania as moderate in EPA’s final 2016 Implementation Number EPA–R03–OAR–2020–0416. All nonattainment for the 2012 annual Rule. documents in the docket are listed on PM2.5 standard. See 80 FR 2206 (January the https://www.regulations.gov 2 B. EPA’s Proposed Action website. Although listed in the index, 15, 2015). For areas designated as nonattainment for one or more NAAQS, At proposal, EPA evaluated the some information is not publicly revised portions 25 Pa. Code Chapters available, e.g., confidential business the SIP must include preconstruction permit requirements for new or 121 and 127 to determine if the information (CBI) or other information revisions meet current applicable whose disclosure is restricted by statute. modified major stationary sources of requirements for a PM2.5 NNSR permit Certain other material, such as such nonattainment pollutant(s), commonly referred to as program, as revised by EPA’s 2016 copyrighted material, is not placed on Implementation Rule. 25 Pa. Code the internet and will be publicly 1 Allegheny County, Pennsylvania sources are 121.1—(1) contains revisions to clarify available only in hard copy form. regulated under the Allegheny County Health that 25 Pa. Code applies to major Publicly available docket materials are Department’s Article XXI, not PADEP 25 Pa. Code. polluting facilities that will emit PM2.5 available through https:// 2 EPA subsequently issued Additional Air Quality or its precursors in areas designated as www.regulations.gov, or please contact Designations and Technical Amendment to Correct FOR FURTHER Inadvertent Error in Air Quality Designations for the person identified in the the 2012 Primary Annual Fine Particulate Matter 3 706 F.3d 428 (D.C. Cir. 2013). 4 INFORMATION CONTACT section for (PM2.5), which impacted Delaware and Lebanon This requirement was codified in 40 CFR additional availability information. counties. 80 FR 18535, 18549 (April 7, 2015). 51.165(a)(13). See 81 FR 58010 (August 24, 2016).

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nonattainment for PM2.5; (2) the the amendments to 40 CFR part 52 sets • Is not a significant regulatory action definition of ‘‘major facility’’ has been forth below. subject to Executive Order 13211 (66 FR updated to include a 70 tons per year EPA has made, and will continue to 28355, May 22, 2001); (tpy) emissions threshold for PM2.5 and make, these materials generally • Is not subject to requirements of all precursors to PM2.5 in a serious available through https:// section 12(d) of the National nonattainment area; (3) the definition of www.regulations.gov and at the EPA Technology Transfer and Advancement ‘‘regulated NSR pollutant’’ has been Region III Office (please contact the Act of 1995 (15 U.S.C. 272 note) because updated to include sulfur dioxide (SO2), person identified in the FOR FURTHER application of those requirements would VOC, and ammonia in all PM2.5 INFORMATION CONTACT section of this be inconsistent with the CAA; and nonattainment areas; (4) revisions were preamble for more information). • made to the definition of ‘‘significant’’ Therefore, these materials have been Does not provide EPA with the discretionary authority to address, as to include emission rates for PM2.5 at 10 approved by EPA for inclusion in the appropriate, disproportionate human tpy and emission rates for PM2.5 SIP, have been incorporated by health or environmental effects, using precursors as follows: 40 tpy of SO2, 40 reference by EPA into that plan, are tpy of VOC, 40 tpy of ammonia, and 40 fully federally enforceable under practicable and legally permissible methods, under Executive Order 12898 tpy of nitrogen oxides (NOX). Section sections 110 and 113 of the CAA as of 127.202(a)—Effective date, was the effective date of the final rule of (59 FR 7629, February 16, 1994). amended to establish that emission of EPA’s approval, and will be In addition, this rule does not have VOC and ammonia will be regulated as incorporated by reference in the next tribal implications as specified by PM2.5 precursors after the effective date update to the SIP compilation.5 Executive Order 13175 (65 FR 67249, of the adoption of the proposed November 9, 2000), because the SIP is rulemaking. EPA proposed to find these V. Statutory and Executive Order not approved to apply in Indian country revisions approvable and consistent Reviews located in the State, and EPA notes that with applicable requirements for a PM2.5 A. General Requirements it will not impose substantial direct NNSR permit program, as revised by the costs on tribal governments or preempt Under the CAA, the Administrator is 2016 Implementation Rule. tribal law. Section 127.203(a)—Facilities subject required to approve a SIP submission to special permit requirements, was that complies with the provisions of the B. Submission to Congress and the amended to add ‘‘significant air quality CAA and applicable Federal regulations. Comptroller General 3 42 U.S.C. 7410(k); 40 CFR 52.02(a). impact’’ levels for PM2.5 at 0.2mg/m for The Congressional Review Act, 5 the annual averaging time and 1.2 mg/m3 Thus, in reviewing SIP submissions, EPA’s role is to approve state choices, U.S.C. 801 et seq., as added by the Small for the 24-hour averaging time. PADEP’s Business Regulatory Enforcement annual averaging time is more stringent provided that they meet the criteria of the CAA. Accordingly, this action Fairness Act of 1996, generally provides than what EPA requires in 40 CFR that before a rule may take effect, the 51.165(b)(2), therefore, EPA finds this merely approves state law as meeting Federal requirements and does not agency promulgating the rule must more stringent requirement approvable. submit a rule report, which includes a Section 127.210(a)—Offset ratios, impose additional requirements beyond those imposed by state law. For that copy of the rule, to each House of the establishes offset ratios for VOC and Congress and to the Comptroller General ammonia at a ratio of 1:1 for flue reason, this action: • Is not a ‘‘significant regulatory of the United States. EPA will submit a emissions and fugitive emissions. EPA report containing this action and other finds the addition of offset ratios to be action’’ subject to review by the Office of Management and Budget under required information to the U.S. Senate, approvable. the U.S. House of Representatives, and Other specific provisions of this SIP Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, the Comptroller General of the United revision and the rationale for EPA’s States prior to publication of the rule in proposed action are explained in the January 21, 2011); • Does not impose an information the Federal Register. A major rule NPRM, and its associated technical cannot take effect until 60 days after it support document (TSD), and will not collection burden under the provisions of the Paperwork Reduction Act (44 is published in the Federal Register. be restated here. No public comments This action is not a ‘‘major rule’’ as were received on the NPRM. U.S.C. 3501 et seq.); • Is certified as not having a defined by 5 U.S.C. 804(2). III. Final Action significant economic impact on a C. Petitions for Judicial Review EPA is approving amendments to 25 substantial number of small entities Pa. Code Chapters 121 (General under the Regulatory Flexibility Act (5 Under section 307(b)(1) of the CAA, Provisions) and 127 (Construction, U.S.C. 601 et seq.); petitions for judicial review of this Modification, Reactivation and • Does not contain any unfunded action must be filed in the United States Operation of Sources), as a revision to mandate or significantly or uniquely Court of Appeals for the appropriate the Pennsylvania SIP. affect small governments, as described circuit by July 12, 2021. Filing a petition in the Unfunded Mandates Reform Act for reconsideration by the Administrator IV. Incorporation by Reference of 1995 (Pub. L. 104–4); of this final rule does not affect the In this document, EPA is finalizing • Does not have Federalism finality of this action for the purposes of regulatory text that includes implications as specified in Executive judicial review nor does it extend the incorporation by reference. In Order 13132 (64 FR 43255, August 10, time within which a petition for judicial accordance with requirements of 1 CFR 1999); review may be filed, and shall not 51.5, EPA is finalizing the incorporation • Is not an economically significant postpone the effectiveness of such rule by reference of certain subsections of 25 regulatory action based on health or or action. This action approving NNSR Pa. Code Chapters 121 (General safety risks subject to Executive Order requirements under the 2012 PM2.5 Provisions) and 127, (Construction, 13045 (62 FR 19885, April 23, 1997); NAAQS may not be challenged later in Modification, Reactivation and proceedings to enforce its requirements. Operation of Sources), as described in 5 62 FR 27968 (May 22, 1997). (See section 307(b)(2).)

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List of Subjects in 40 CFR Part 52 PART 52—APPROVAL AND ‘‘Section 121.1’’ after a third existing Environmental protection, Air PROMULGATION OF entry for ‘‘Section 121.1’’; pollution control, Carbon monoxide, IMPLEMENTATION PLANS ■ b. Under ‘‘Chapter 127—Construction, Incorporation by reference, Modification, Reactivation, and Intergovernmental relations, Nitrogen ■ 1. The authority citation for part 52 Operation of Sources, Subchapter E’’ by dioxide, Particulate matter, Reporting continues to read as follows: revising the entries for ‘‘Section 127.202’’, ‘‘Section 127.203a’’, and and recordkeeping requirements, Sulfur Authority: 42 U.S.C. 7401 et seq. oxides, Volatile organic compounds. ‘‘Section 127.210’’. The addition and revisions read as Dated: May 6, 2021. Subpart NN—Pennsylvania follows: Diana Esher, Acting Regional Administrator, Region III. ■ 2. In § 52.2020, the table in paragraph § 52.2020 Identification of plan. For the reasons stated in the (c)(1) is amended by: * * * * * preamble, the EPA amends 40 CFR part ■ a. Under ‘‘Chapter 121—General (c) * * * 52 as follows: Provisions’’ by adding a fourth entry for (1) * * *

State Additional State citation Title/subject effective EPA explanation/§ 52.2063 date approval date citation

Title 25—Environmental Protection Article III—Air Resources

*******

Chapter 121—General Provisions

******* Section 121.1 ...... Definitions ...... 12/21/19 5/12/21, [insert Federal Revised definitions for ‘‘major facility,’’ ‘‘regulated Register citation]. NSR pollutant,’’ and ‘‘significant’’ to address 2016 PM2.5 Implementation Rule requirements.

*******

Chapter 127—Construction, Modification, Reactivation, and Operation of Sources

*******

Subchapter E—New Source Review

******* Section 127.202 ..... Effective date ...... 12/21/19 5/12/21, [insert Federal Revised to include VOC and ammonia as PM2.5 pre- Register citation]. cursors. Previous approval was July 13, 2012. Docket No. EPA–R03–OAR–2011–0924.

******* Section 127.203a ... Applicability deter- 12/21/19 5/12/21, [insert Federal Revised to include annual and 24-hour levels for mination. Register citation]. ‘‘significant air quality impacts for PM2.5.’’ Previous approval was July 13, 2012. Docket No. EPA–R03–OAR–2011–0924.

******* Section 127.210 ..... Offset ratios ...... 12/21/19 5/12/21, [insert Federal Revised to include PM2.5 offset ratios for both VOC Register citation]. and ammonia. Previous approval was July 13, 2012. Docket No. EPA–R03–OAR–2011–0924.

*******

* * * * * [FR Doc. 2021–10041 Filed 5–11–21; 8:45 am] BILLING CODE 6560–50–P

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ENVIRONMENTAL PROTECTION information about CBI or multimedia definitions for the phrases AGENCY submissions, and general guidance on ‘‘Functionally equivalent component’’ making effective comments, please visit and ‘‘Process Unit’’, along with 40 CFR Part 52 http://www2.epa.gov/dockets/ revisions to the definition ‘‘Net [EPA–R05–OAR–2020–0412; FRL–10023– commenting-epa-dockets. emissions increase’’. Additionally, 86–Region 5] FOR FURTHER INFORMATION CONTACT: portions of R 336.2802 and R 336.2902 YeChan Lim, Environmental Engineer, were based on identical Federal Air Plan Approval; Michigan; Part 18 Air Permits Section, Air Programs language, and revisions were made to and Part 19 Revisions Branch (AR–18J), Environmental ensure consistency in rule interpretation AGENCY: Environmental Protection Protection Agency, Region 5, 77 West across both of these rule parts and with Agency (EPA). Jackson Boulevard, Chicago, Illinois Federal regulations. These revisions 60604, (312) 886–7259, lim.yechan@ ACTION: Direct final rule. were made to ensure consistency with epa.gov. The EPA Region 5 office is Federal rule language and other parts of SUMMARY: The Environmental Protection open from 8:30 a.m. to 4:30 p.m., the Michigan air quality rules. Finally, Agency (EPA) is approving Michigan Monday through Friday, excluding EPA is approving into the Michigan SIP, Department of Environment, Great Federal holidays and facility closures the removal of R 336.2901a from Part Lakes, and Energy (EGLE) promulgated due to COVID–19. 19. R 336.2901a, the adoption by revisions to its Part 18 Prevention of SUPPLEMENTARY INFORMATION: reference, was transferred to Part 9 of Significant Deterioration of Air Quality Throughout this document whenever rule and the Part 19 New Source Review Michigan’s administrative rules. EGLE ‘‘we,’’ ‘‘us,’’ or ‘‘our’’ is used, we mean also requested the removal of for Major Sources Impacting EPA. Nonattainment Areas rule. The revisions R 336.2801a from Part 18 of the SIP made to Part 18 and Part 19 were I. What action is EPA taking? however, R 336.2801a was never adopted to ensure consistency with On August 5, 2020, EGLE submitted a approved into the SIP. Therefore, EPA Federal rule language and other parts of revision to its Michigan State will not be acting on that request. the Michigan air quality rules. The rule Implementation Plan (SIP). The changes We are publishing this action without changes are administrative and are are administrative and involve wording prior proposal because we view this as intended to provide clarity to the changes to ensure consistency across the a noncontroversial amendment and already approved rule language. Michigan Part 18 and 19 rules, updates anticipate no adverse comments. DATES: This direct final rule is effective to make the Michigan rules consistent However, in the proposed rules section July 12, 2021, unless EPA receives with Federal requirements, transfer of of this Federal Register publication, we adverse comments by June 11, 2021. If adoptions by reference, and corrections are publishing a separate document that adverse comments are received, EPA to grammar and typographical errors. will serve as the proposal to approve the will publish a timely withdrawal of the EPA is approving into the Michigan state plan if relevant adverse written direct final rule in the Federal Register SIP revisions to Michigan air pollution comments are filed. This rule will be informing the public that the rule will control rules Part 18, Prevention of effective July 12, 2021 without further not take effect. Significant Deterioration of Air Quality. notice unless we receive relevant ADDRESSES: Submit your comments, Specifically, we are approving revisions adverse written comments by June 11, identified by Docket ID No. EPA–R05– to R 336.2801 ‘‘Definitions’’, R 336.2802 OAR–2020–0412 at http:// ‘‘Applicability’’, R 336.2809 2021. If we receive such comments, we www.regulations.gov or via email to ‘‘Exemptions’’, R 336.2810 ‘‘Control will withdraw this action before the [email protected]. For technology review’’, R 336.2813 ‘‘Air effective date by publishing a comments submitted at Regulations.gov, quality analysis’’, R 336.2816 ‘‘Sources subsequent document that will follow the online instructions for impacting federal class I areas; withdraw the final action. All public submitting comments. Once submitted, additional requirements’’, and R comments received will then be comments cannot be edited or removed 336.2823 ‘‘Actuals plantwide addressed in a subsequent final rule from Regulations.gov. For either manner applicability limits (PALs)’’. These based on the proposed action. EPA will of submission, EPA may publish any revisions were made to ensure not institute a second comment period. comment received to its public docket. consistency with Federal rule language Any parties interested in commenting Do not submit electronically any and other parts of the Michigan air on this action should do so at this time. information you consider to be quality rules. Please note that if EPA receives adverse Confidential Business Information (CBI) EPA is also approving into the comment on an amendment, paragraph, or other information whose disclosure is Michigan SIP revisions to Part 19, New or section of this rule and if that restricted by statute. Multimedia Source Review for Major Sources provision may be severed from the submissions (audio, video, etc.) must be Impacting Nonattainment Areas. remainder of the rule, EPA may adopt accompanied by a written comment. Specifically, we are approving revisions as final those provisions of the rule that The written comment is considered the to R 336.2901 ‘‘Definitions’’, R 336.2902 are not the subject of an adverse official comment and should include ‘‘Applicability’’, R 336.2903 comment. If we do not receive any discussion of all points you wish to ‘‘Additional permit requirements for comments, this action will be effective make. EPA will generally not consider sources impacting nonattainment July 12, 2021. comments or comment contents located areas’’, R 336.2907 ‘‘Actuals plant wide outside of the primary submission (i.e. applicability limits or PALs’’, and II. Incorporation by Reference on the web, cloud, or other file sharing R 336.2908 ‘‘Conditions for approval of system). For additional submission a major new source review permit in a In this rule, EPA is finalizing methods, please contact the person nonattainment area’’. Part 19 was regulatory text that includes identified in the FOR FURTHER missing definitions that were in the incorporation by reference. In INFORMATION CONTACT section. For the corresponding Federal regulations. The accordance with requirements of 1 CFR full EPA public comment policy, R 336.2901 revisions provided

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51.5, EPA is finalizing the incorporation in the Unfunded Mandates Reform Act it extend the time within which a by reference of the Michigan of 1995 (Pub. L. 104–4); petition for judicial review may be filed, Regulations described in the • Does not have federalism and shall not postpone the effectiveness amendments to 40 CFR part 52 set forth implications as specified in Executive of such rule or action. Parties with below. EPA has made, and will continue Order 13132 (64 FR 43255, August 10, objections to this direct final rule are to make, these documents generally 1999); encouraged to file a comment in available through www.regulations.gov • Is not an economically significant response to the parallel notice of and at the EPA Region 5 Office (please regulatory action based on health or proposed rulemaking for this action contact the person identified in the FOR safety risks subject to Executive Order published in the proposed rules section FURTHER INFORMATION CONTACT section of 13045 (62 FR 19885, April 23, 1997); of today’s Federal Register, rather than this preamble for more information). • Is not a significant regulatory action file an immediate petition for judicial Therefore, these materials have been subject to Executive Order 13211 (66 FR review of this direct final rule, so that approved by EPA for inclusion in the 28355, May 22, 2001); EPA can withdraw this direct final rule SIP, have been incorporated by • Is not subject to requirements of and address the comment in the reference by EPA into that plan, are Section 12(d) of the National proposed rulemaking. This action may fully federally enforceable under Technology Transfer and Advancement not be challenged later in proceedings to sections 110 and 113 of the Clean Air Act of 1995 (15 U.S.C. 272 note) because enforce its requirements. (See section Act as of the effective date of the final application of those requirements would 307(b)(2) of the Clean Air Act.) rulemaking of EPA’s approval, and will be inconsistent with the Clean Air Act; List of Subjects in 40 CFR Part 52 be incorporated by reference in the next and 1 update to the SIP compilation. • Does not provide EPA with the Environmental protection, Air Also in this document, as described in discretionary authority to address, as pollution control, Carbon monoxide, the amendments to 40 CFR part 52 set appropriate, disproportionate human Incorporation by reference, forth below, EPA is removing provisions health or environmental effects, using Intergovernmental relations, Lead, of the EPA-Approved Michigan practicable and legally permissible Nitrogen dioxide, Ozone, Particulate Regulations and Statutes from the methods, under Executive Order 12898 matter, Reporting and recordkeeping Michigan SIP, which is incorporated by (59 FR 7629, February 16, 1994). requirements, Sulfur oxides, Volatile reference in accordance with the In addition, the SIP is not approved organic compounds. requirements of 1 CFR part 51. to apply on any Indian reservation land Dated: May 7, 2021. III. Statutory and Executive Order or in any other area where EPA or an Cheryl Newton, Reviews Indian tribe has demonstrated that a Acting Regional Administrator, Region 5. tribe has jurisdiction. In those areas of Under the Clean Air Act, the Indian country, the rule does not have For the reasons stated in the Administrator is required to approve a tribal implications and will not impose preamble, EPA amends title 40 CFR part SIP submission that complies with the substantial direct costs on tribal 52 as follows: provisions of the Clean Air Act and governments or preempt tribal law as applicable Federal regulations. 42 specified by Executive Order 13175 (65 PART 52—APPROVAL AND U.S.C. 7410(k); 40 CFR 52.02(a). Thus, FR 67249, November 9, 2000). PROMULGATION OF in reviewing SIP submissions, EPA’s The Congressional Review Act, 5 IMPLEMENTATION PLANS role is to approve state choices, U.S.C. 801 et seq., as added by the Small provided that they meet the criteria of Business Regulatory Enforcement ■ 1. The authority citation for part 52 the Clean Air Act. Accordingly, this Fairness Act of 1996, generally provides continues to read as follows: action merely approves state law as that before a rule may take effect, the Authority: 42 U.S.C. 7401 et seq. meeting Federal requirements and does agency promulgating the rule must not impose additional requirements submit a rule report, which includes a ■ 2. In § 52.1170, the table in paragraph beyond those imposed by state law. For copy of the rule, to each House of the (c) is amended: that reason, this action: Congress and to the Comptroller General • ■ a. Under ‘‘Part 18. Prevention of Is not a significant regulatory action of the United States. EPA will submit a Significant Deterioration of Air Quality’’ subject to review by the Office of report containing this action and other by revising the entries for R 336.2801, Management and Budget under required information to the U.S. Senate, R 336.2802, R 336.2809, R 336.2810, R Executive Orders 12866 (58 FR 51735, the U.S. House of Representatives, and 336.2813, R 336.2816, and R 336.2823; October 4, 1993) and 13563 (76 FR 3821, the Comptroller General of the United and January 21, 2011); States prior to publication of the rule in • Does not impose an information the Federal Register. A major rule ■ b. Under ‘‘Part 19. New Source collection burden under the provisions cannot take effect until 60 days after it Review for Major Sources Impacting of the Paperwork Reduction Act (44 is published in the Federal Register. Nonattainment Areas’’: U.S.C. 3501 et seq.); This action is not a ‘‘major rule’’ as ■ i. By revising the entries for • Is certified as not having a defined by 5 U.S.C. 804(2). R 336.2901, R 336.2902, R 336.2903, significant economic impact on a Under section 307(b)(1) of the Clean R 336.2907, and R 336.2908; and substantial number of small entities Air Act, petitions for judicial review of ■ ii. By removing without replacement under the Regulatory Flexibility Act (5 this action must be filed in the United the entry for R 336.2901a. U.S.C. 601 et seq.); States Court of Appeals for the • Does not contain any unfunded appropriate circuit by July 12, 2021. The revisions read as follows: mandate or significantly or uniquely Filing a petition for reconsideration by § 52.1170 Identification of plan. affect small governments, as described the Administrator of this final rule does not affect the finality of this action for * * * * * 1 62 FR 27968 (May 22, 1997). the purposes of judicial review nor does (c) * * *

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EPA-APPROVED MICHIGAN REGULATIONS

State Michigan citation Title effective EPA approval date Comments date

*******

Part 18. Prevention of Significant Deterioration of Air Quality

R 336.2801 ...... Definitions ...... 01/02/2019 May 12, 2021, [INSERT Federal Register CITATION]. R 336.2802 ...... Applicability ...... 01/02/2019 [May 12, 2021, [INSERT Federal Register CITATION].

******* R 336.2809 ...... Exemptions ...... 01/02/2019 May 12, 2021, [INSERT Federal Register CITATION]. R 336.2810 ...... Control technology review ...... 01/02/2019 May 12, 2021, [INSERT Federal Register CITATION].

******* R 336.2813 ...... Air quality analysis ...... 01/02/2019 May 12, 2021, [INSERT Federal Register CITATION].

******* R 336.2816 ...... Sources impacting federal class I 01/02/2019 May 12, 2021, [INSERT Federal areas; additional requirements. Register CITATION].

******* R 336.2823...... Actuals plantwide applicability 01/02/2019 May 12, 2021, [INSERT Federal limits (PALs). Register CITATION].

Part 19. New Source Review for Major Sources Impacting Nonattainment Areas

R 336.2901 ...... Definitions ...... 01/02/2019 May 12, 2021, [INSERT Federal Register CITATION]. R 336.2902 ...... Applicability ...... 01/02/2019 May 12, 2021, [INSERT Federal Register CITATION]. R 336.2903...... Additional permit requirements 01/02/2019 May 12, 2021, [INSERT Federal for sources impacting non- Register CITATION]. attainment areas. R 336.2907...... Actuals plant wide applicability 01/02/2019 May 12, 2021, [INSERT Federal limits or PALs. Register CITATION]. R 336.2908...... Conditions for approval of a 01/02/2019 May 12, 2021, [INSERT Federal major new source review per- Register CITATION]. mit in a nonattainment area.

*******

* * * * * sarcosinate when used as an inert hearings must be received on or before [FR Doc. 2021–10044 Filed 5–11–21; 8:45 am] ingredient in antimicrobial pesticide July 12, 2021, and must be filed in BILLING CODE 6560–50–P formulations applied to food-contact accordance with the instructions surfaces in public eating places, dairy- provided in 40 CFR part 178 (see also processing equipment, and food- Unit I.C. of the SUPPLEMENTARY ENVIRONMENTAL PROTECTION processing equipment and utensils at an INFORMATION). AGENCY end-use concentration not to exceed 10,000 parts per million (ppm). Clorox ADDRESSES: The docket for this action, 40 CFR Part 180 Services Company representing Clorox identified by docket identification (ID) [EPA–HQ–OPP–2020–0451; FRL–10022–72] Professional Products Company number EPA–HQ–OPP–2020–0451, is submitted a petition to EPA under the available at http://www.regulations.gov Sodium lauroyl sarcosinate; Federal Food, Drug, and Cosmetic Act or at the Office of Pesticide Programs Exemption From the Requirement of a (FFDCA), requesting establishment of an Regulatory Public Docket (OPP Docket) Tolerance exemption from the requirement of a in the Environmental Protection Agency AGENCY: Environmental Protection tolerance. This regulation eliminates the Docket Center (EPA/DC), West William Agency (EPA). need to establish a maximum Jefferson Clinton Bldg., Rm. 3334, 1301 permissible level for residues of sodium Constitution Ave. NW, Washington, DC ACTION: Final rule. lauroyl sarcosinate when used in 20460–0001. The Public Reading Room SUMMARY: This regulation establishes an accordance with this exemption. is open from 8:30 a.m. to 4:30 p.m., exemption from the requirement of a DATES: This regulation is effective May Monday through Friday, excluding legal tolerance for residues of sodium lauroyl 12, 2021. Objections and requests for holidays. The telephone number for the

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Public Reading Room is (202) 566–1744, objections and requests for a hearing www.regulations.gov. There were no and the telephone number for the OPP must be in writing and must be received comments received in response to the Docket is (703) 305–5805. by the Hearing Clerk on or before July notice of filing. Due to the public health concerns 12, 2021. Addresses for mail and hand III. Inert Ingredient Definition related to COVID–19, the EPA Docket delivery of objections and hearing Center (EPA/DC) and Reading Room is requests are provided in 40 CFR Inert ingredients are all ingredients closed to visitors with limited 178.25(b). that are not active ingredients as defined exceptions. The staff continues to In addition to filing an objection or in 40 CFR 153.125 and include, but are provide remote customer service via hearing request with the Hearing Clerk not limited to, the following types of email, phone, and webform. For the as described in 40 CFR part 178, please ingredients (except when they have a latest status information on EPA/DC submit a copy of the filing (excluding pesticidal efficacy of their own): services and docket access, visit https:// any Confidential Business Information Solvents such as alcohols and www.epa.gov/dockets. (CBI)) for inclusion in the public docket. hydrocarbons; surfactants such as FOR FURTHER INFORMATION CONTACT: Information not marked confidential polyoxyethylene polymers and fatty Marietta Echeverria, Registration pursuant to 40 CFR part 2 may be acids; carriers such as clay and Division (7505P), Office of Pesticide disclosed publicly by EPA without prior diatomaceous earth; thickeners such as carrageenan and modified cellulose; Programs, Environmental Protection notice. Submit the non-CBI copy of your wetting, spreading, and dispersing Agency, 1200 Pennsylvania Ave. NW, objection or hearing request, identified agents; propellants in aerosol Washington, DC 20460–0001; main by docket ID number EPA–HQ–OPP– dispensers; microencapsulating agents; telephone number: (703) 305–7090; 2020–0451, by one of the following and emulsifiers. The term ‘‘inert’’ is not email address: [email protected]. methods: • Federal eRulemaking Portal: http:// intended to imply nontoxicity; the SUPPLEMENTARY INFORMATION: www.regulations.gov. Follow the online ingredient may or may not be I. General Information instructions for submitting comments. chemically active. Generally, EPA has Do not submit electronically any exempted inert ingredients from the A. Does this action apply to me? information you consider to be CBI or requirement of a tolerance based on the You may be potentially affected by other information whose disclosure is low toxicity of the individual inert this action if you are an agricultural restricted by statute. ingredients. • Mail: OPP Docket, Environmental producer, food manufacturer, or IV. Aggregate Risk Assessment and Protection Agency Docket Center (EPA/ pesticide manufacturer. The following Determination of Safety list of North American Industrial DC), (28221T), 1200 Pennsylvania Ave. Classification System (NAICS) codes is NW, Washington, DC 20460–0001. Section 408(c)(2)(A)(i) of the FFDCA not intended to be exhaustive, but rather • Hand Delivery: To make special allows EPA to establish an exemption provides a guide to help readers arrangements for hand delivery or from the requirement for a tolerance (the determine whether this document delivery of boxed information, please legal limit for a pesticide chemical applies to them. Potentially affected follow the instructions at http:// residue in or on a food) only if EPA entities may include: www.epa.gov/dockets/contacts.html. determines that the exemption is ‘‘safe.’’ • Crop production (NAICS code 111). Additional instructions on Section 408(c)(2)(A)(ii) of the FFDCA • Animal production (NAICS code commenting or visiting the docket, defines ‘‘safe’’ to mean that EPA has 112). along with more information about determined that ‘‘there is a reasonable • Food manufacturing (NAICS code dockets generally, is available at http:// certainty that no harm will result from 311). www.epa.gov/dockets. aggregate exposure to the pesticide • chemical residue, including all Pesticide manufacturing (NAICS II. Petition for Exemption code 32532). anticipated dietary exposures and all In the Federal Register of September other exposures for which there is B. How can I get electronic access to 30, 2020 (85 FR 61681) (FRL–10014–74), reliable information.’’ This includes other related information? EPA issued a document pursuant to exposure through drinking water and in You may access a frequently updated FFDCA section 408, 21 U.S.C. 346a, residential settings but does not include electronic version of 40 CFR part 180 announcing the filing of a pesticide occupational exposure. Section through the Government Publishing petition (PP IN–11391) by Clorox 408(b)(2)(C) of FFDCA requires EPA to Office’s e-CFR site at http:// Services Company representing Clorox give special consideration to exposure www.ecfr.gov/cgi-bin/text-idx?&c= Professional Products Company, P.O. of infants and children to the pesticide ecfr&tpl=/ecfrbrowse/Title40/40tab_ Box 493, Pleasanton, CA 94566–0803. chemical residue in establishing an 02.tpl. The petition requested that 40 CFR exemption and to ‘‘ensure that there is 180.940(a) be amended by establishing a reasonable certainty that no harm will C. How can I file an objection or hearing an exemption from the requirement of a result to infants and children from request? tolerance for residues of sodium lauroyl aggregate exposure to the pesticide Under FFDCA section 408(g), 21 sarcosinate (CAS Reg. No. 137–16–6) chemical residue.’’ U.S.C. 346a(g), any person may file an when used as an inert ingredient at an EPA establishes exemptions from the objection to any aspect of this regulation end-use concentration not to exceed requirement of a tolerance only in those and may also request a hearing on those 10,000 ppm in antimicrobial pesticide cases where it can be clearly objections. You must file your objection formulations applied to food-contact demonstrated that the risks from or request a hearing on this regulation surfaces in public eating places, dairy- aggregate exposure to pesticide in accordance with the instructions processing equipment, and food- chemical residues under reasonably provided in 40 CFR part 178. To ensure processing equipment and utensils. That foreseeable circumstances will pose no proper receipt by EPA, you must document referenced a summary of the harm to human health. In order to identify docket ID number EPA–HQ– petition prepared by Clorox Services determine the risks from aggregate OPP–2020–0451 in the subject line on Company, the petitioner, which is exposure to pesticide inert ingredients, the first page of your submission. All available in the docket, http:// the Agency considers the toxicity of the

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inert in conjunction with possible caused minimal eye irritation, did not containing runoff from soils containing exposure to residues of the inert cause skin irritation, and was not a skin the treated crops. In addition, sodium ingredient through food, drinking water, sensitizer. lauroyl sarcosinate is used as an and through other exposures that occur Repeat dose oral toxicity testing in additive in food packaging. However, no as a result of pesticide use in residential rats include a 90-day, 6-month, and 2- toxicological endpoint of concern was settings. If EPA is able to determine that year study. In addition, a developmental identified for sodium lauroyl a tolerance is not necessary to ensure toxicity test was conducted. High sarcosinate and therefore, a quantitative that there is a reasonable certainty that repeated exposures to sodium lauroyl assessment of dietary exposure is not no harm will result from aggregate sarcosinate in the diet resulted in minor necessary. exposure to the inert ingredient, an irritation to the stomach in studies up 2. Non-dietary exposure. The term exemption from the requirement of a to 2 years. This effect was not seen as ‘‘residential exposure’’ is used in this tolerance may be established. an adverse effect of treatment and document to refer to non-occupational, Consistent with FFDCA section therefore, the NOAEL for the 6-month non-dietary exposure (e.g., textiles 408(c)(2)(A), and the factors specified in and 2-year studies were 1,000 mg/kg/ (clothing and diapers), carpets, FFDCA section 408(c)(2)(B), EPA has day, the highest dose tested. When the swimming pools, and hard surface reviewed the available scientific data test substance was administered by disinfection on walls, floors, tables). and other relevant information in gavage, the effects were more severe and Residential exposure to sodium support of this action. EPA has include, in addition to increasing lauroyl sarcosinate may occur based on sufficient data to assess the hazards of thickness in the stomach wall, a yellow its use as an inert ingredient in pesticide and to make a determination on discoloration of non-glandular gastric formulations registered for residential aggregate exposure to sodium lauroyl mucosa, more severe squamous cell uses. Additional non-dietary exposure sarcosinate, including exposure hyperplasia, hyperkeratosis/ may occur from use of sodium lauroyl resulting from the exemption parakeratosis, inflammation and edema sarcosinate in household products and established by this action. EPA’s of the non-glandular gastric mucosa. cosmetics. However, no toxicological assessment of exposures and risks Systemic effects of sodium lauroyl endpoint of concern was identified for associated with sodium lauroyl sarcosinate have not been observed in sodium lauroyl sarcosinate and sarcosinate follows. animal studies. therefore a quantitative residential Sodium lauroyl sarcosine tested exposure assessment for sodium lauroyl A. Toxicological Profile negative for genotoxic effects in various sarcosinate was not conducted. EPA has evaluated the available studies. Similarly, there was no 3. Cumulative effects from substances toxicity data and considered their evidence of carcinogenicity or with a common mechanism of toxicity. validity, completeness, and reliability as neuropathological changes or effects Section 408(b)(2)(D)(v) of FFDCA well as the relationship of the results of reported in any of the studies. The requires that, when considering whether the studies to human risk. EPA has also agency does not believe sodium lauroyl to establish, modify, or revoke a considered available information sarcosine is carcinogenic or neurotoxic. tolerance, the Agency consider concerning the variability of the ‘‘available information’’ concerning the sensitivities of major identifiable B. Toxicological Points of Departure/ cumulative effects of a particular subgroups of consumers, including Levels of Concern pesticide’s residues and ‘‘other infants and children. Specific The local effects seen in the stomach substances that have a common information on the studies received and in the 90-day and developmental mechanism of toxicity.’’ the nature of the adverse effects caused studies are the result of gavage dosing EPA has not found sodium lauroyl by sodium lauroyl sarcosinate as well as and are not relevant for end point sarcosinate to share a common the no-observed-adverse-effect-level selection for the purposes of assessing mechanism of toxicity with any other (NOAEL) and the lowest-observed- this chemical as an inert ingredient in substances, and sodium lauroyl adverse-effect-level (LOAEL) from the pesticide formulations. Therefore, no sarcosinate does not appear to produce toxicity studies are discussed in this toxicological significant endpoint of a toxic metabolite produced by other unit. concern for sodium lauroyl sarcosinate substances. For the purposes of this Sodium lauroyl sarcosinate is has been identified in the database. action, therefore, EPA has assumed that metabolized to the fatty acid lauric acid sodium lauroyl sarcosinate does not C. Exposure Assessment and the amino acid sarcosine, both of have a common mechanism of toxicity which are found naturally in food. 1. Dietary exposure from food, feed with other substances. For information Sodium lauroyl sarcosinate has low uses, and drinking water. In evaluating regarding EPA’s efforts to determine acute oral toxicity, and results on a dietary exposure to sodium lauroyl which chemicals have a common surrogate chemical showed low dermal sarcosinate, EPA considered exposure mechanism of toxicity and to evaluate toxicity. Two acute inhalation studies in under the proposed exemption from the the cumulative effects of such rats showed varying LC50 values (lethal requirement of a tolerance. Sodium chemicals, see EPA’s website at http:// concentration for 50% of the animals), lauroyl sarcosinate is currently exempt www.epa.gov/pesticides/cumulative. with one study reporting the LC50 to be from the requirement of a tolerance between 0.05–0.5 mg/L and the other under 40 CFR 180.1207 for use as an D. Safety Factor for Infants and Children indicating a LC50 of 1 to 5 mg/L. These inert ingredient (surfactant) at levels not studies indicate that sodium lauroyl to exceed 10% in pesticide formulations Section 408(b)(2)(C) of the FFDCA sarcosinate is potentially toxic if containing glyphosate. Dietary exposure requires EPA to retain an additional inhaled. However, inhalation exposure to sodium lauroyl sarcosinate may occur tenfold margin of safety in the case of to sodium lauroyl sarcosinate is not from eating foods treated with pesticide threshold effects to ensure that there is likely because it is unlikely that sodium formulations containing this inert a reasonable certainty that no harm will lauroyl sarcosinate will volatilize based ingredient, from eating foods that come result to infants and children from on its physical/chemical properties (e.g. in contact with surfaces treated with aggregate exposure to the pesticide vapor pressure and Henry’s Law pesticide formulations containing the chemical residue. As noted in Unit Constant). Sodium lauroyl sarcosinate inert ingredient, and drinking water IV.B., there is no indication of threshold

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effects being caused by sodium lauroyl Agency. The Office of Management and 9, 2000) do not apply to this action. In sarcosinate. Therefore, this requirement Budget (OMB) has exempted these types addition, this action does not impose does not apply to the present analysis. of actions from review under Executive any enforceable duty or contain any Moreover, due to the lack of any Order 12866, entitled ‘‘Regulatory unfunded mandate as described under toxicological endpoints of concern, EPA Planning and Review’’ (58 FR 51735, Title II of the Unfunded Mandates conducted a qualitative assessment of October 4, 1993). Because this action Reform Act (UMRA) (2 U.S.C. 1501 et magnesium sulfate, which does not use has been exempted from review under seq.). safety factors for assessing risk, and no Executive Order 12866, this action is This action does not involve any additional safety factor is needed for not subject to Executive Order 13211, technical standards that would require assessing risk to infants and children. entitled ‘‘Actions Concerning Agency consideration of voluntary E. Aggregate Risks and Determination of Regulations That Significantly Affect consensus standards pursuant to section Safety Energy Supply, Distribution, or Use’’ (66 12(d) of the National Technology FR 28355, May 22, 2001) or Executive Transfer and Advancement Act Taking into consideration all available Order 13045, entitled ‘‘Protection of (NTTAA) (15 U.S.C. 272 note). information on sodium lauroyl Children from Environmental Health sarcosinate, EPA has determined that Risks and Safety Risks’’ (62 FR 19885, VIII. Congressional Review Act there is a reasonable certainty that no April 23, 1997). This action does not Pursuant to the Congressional Review harm to the general population or any contain any information collections Act (5 U.S.C. 801 et seq.), EPA will population subgroup, including infants subject to OMB approval under the submit a report containing this rule and and children, will result from aggregate Paperwork Reduction Act (PRA) (44 other required information to the U.S. exposure to sodium lauroyl sarcosinate. U.S.C. 3501 et seq.), nor does it require Senate, the U.S. House of Therefore, the establishment of an any special considerations under Representatives, and the Comptroller exemption from the requirement of a Executive Order 12898, entitled General of the United States prior to tolerance under 40 CFR 180.940(a) for ‘‘Federal Actions to Address publication of the rule in the Federal residues of sodium lauroyl sarcosinate Environmental Justice in Minority Register. This action is not a ‘‘major when used as an inert ingredient in Populations and Low-Income rule’’ as defined by 5 U.S.C. 804(2). antimicrobial pesticide formulations Populations’’ (59 FR 7629, February 16, applied to food-contact surfaces in 1994). List of Subjects in 40 CFR Part 180 public eating places, dairy-processing Since tolerances and exemptions that Environmental protection, equipment, and food-processing are established on the basis of a petition Administrative practice and procedure, equipment and utensils at a maximum under FFDCA section 408(d), such as Agricultural commodities, Pesticides end-use concentration of 10,000 ppm is the exemption in this final rule, do not and pests, Reporting and recordkeeping safe under FFDCA section 408. require the issuance of a proposed rule, requirements. V. Analytical Enforcement Methodology the requirements of the Regulatory Dated: May 4, 2021. Flexibility Act (RFA) (5 U.S.C. 601 et An analytical method is not required Marietta Echeverria, seq.), do not apply. for enforcement purposes since the Acting Director, Registration Division, Office Agency is establishing an exemption This action directly regulates growers, of Pesticide Programs. from the requirement of a tolerance food processors, food handlers, and food without any numerical limitation. retailers, not States or Tribes, nor does Therefore, for the reasons stated in the this action alter the relationships or preamble, 40 CFR chapter I is amended VI. Conclusions distribution of power and as follows: Therefore, an exemption from the responsibilities established by Congress PART 180—TOLERANCES AND requirement of a tolerance is established in the preemption provisions of FFDCA EXEMPTIONS FOR PESTICIDE under 40 CFR 180.940(a) for sodium section 408(n)(4). As such, the Agency CHEMICAL RESIDUES IN FOOD lauroyl sarcosinate (CAS Reg. No. 137– has determined that this action will not have a substantial direct effect on States 16–6) when used as an inert ingredient ■ or Tribal Governments, on the 1. The authority citation for part 180 in antimicrobial pesticide formulations continues to read as follows: applied to food-contact surfaces in relationship between the National public eating places, dairy-processing Government and the States or Tribal Authority: 21 U.S.C. 321(q), 346a and 371. equipment, and food-processing Governments, or on the distribution of ■ 2. In § 180.940, in paragraph (a), add equipment and utensils at an end-use power and responsibilities among the alphabetically the inert ingredient concentration not to exceed 10,000 various levels of government or between ‘‘Sodium lauroyl sarcosinate’’ to table ppm. the Federal Government and Indian 180.940(a) to read as follows: Tribes. Thus, the Agency has VII. Statutory and Executive Order determined that Executive Order 13132, § 180.940 Tolerance exemptions for active Reviews entitled ‘‘Federalism’’ (64 FR 43255, and inert ingredients for use in This action establishes an exemption August 10, 1999) and Executive Order antimicrobial formulations (Food-contact from the requirement of a tolerance 13175, entitled ‘‘Consultation and surface sanitizing solutions). under FFDCA section 408(d) in Coordination with Indian Tribal * * * * * response to a petition submitted to the Governments’’ (65 FR 67249, November (a) * * *

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TABLE 180.940(a)

Pesticide chemical CAS reg. No. Limits

******* Sodium lauroyl sarcosinate ...... 137–16–6 When ready for use, the end-use concentration is not to exceed 10,000 ppm.

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* * * * * [FR Doc. 2021–10000 Filed 5–11–21; 8:45 am] BILLING CODE 6560–50–P

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Proposed Rules Federal Register Vol. 86, No. 90

Wednesday, May 12, 2021

This section of the FEDERAL REGISTER Instructions: All comments received proposed rule is to ensure that the contains notices to the public of the proposed must include the docket number AMS– origin of livestock provisions for organic issuance of rules and regulations. The NOP–11–0009; NOP–21–04PR, and/or dairy animals are consistently applied purpose of these notices is to give interested Regulatory Information Number (RIN) by all certifying agents. The proposed persons an opportunity to participate in the 0581–AD89 for this rulemaking. You rule would require that organic milk rule making prior to the adoption of the final rules. should clearly indicate the topic and and milk products must be from animals section number of this proposed rule to that have been under continuous which your comment refers, state your organic management from the last third DEPARTMENT OF AGRICULTURE position(s), offer any recommended of gestation onward, with a limited language change(s), and include exception for newly certified organic Agricultural Marketing Service relevant information and data to support dairy producers. Those producers have your position(s) (e.g., scientific, the opportunity to transition non- 7 CFR Part 205 environmental, manufacturing, organic livestock that has been under industry, or industry impact [Document Number AMS–NOP–11–0009; continuous organic management for NOP–21–04PR] information, etc.). All comments and twelve months into organic production. relevant background documents posted Once transitioned, the proposed rule RIN 0581–AD89 to https://www.regulations.gov will would not distinguish between include any personal information transitioned livestock and those that National Organic Program; Origin of provided. were under continuous organic Livestock; Reopening of Comment management from the last third of Period FOR FURTHER INFORMATION CONTACT: Jennifer Tucker, Deputy Administrator, gestation onward. AMS received AGENCY: Agricultural Marketing Service, National Organic Program, USDA– numerous comments that advocated for USDA. AMS–NOP, 1400 Independence Ave. different approaches that were not part ACTION: Proposed rule; reopening of SW, Room 2642–S, Stop 0268, of the proposed rule. AMS is issuing comment period. Washington, DC 20250–0268. (202) 260– this notice to request public input on 8077 those different approaches and to SUMMARY: The U.S. Department of SUPPLEMENTARY INFORMATION: On April provide an updated economic analysis. Agriculture (USDA) Agricultural 28, 2015, AMS (‘‘we’’) published in the First, in the 2015 proposed rule, we Marketing Service (AMS) is reopening Federal Register (80 FR 23455) a declined to limit the movement of the comment period on our April 28, proposed rule to clarify requirements for transitioned cows because we ‘‘believe 2015, proposed rule to amend the origin organic dairy farms under the USDA that some movement or inter-farm sales of livestock requirements for dairy organic regulations. The proposed rule of transitioned animals is reasonable animals under the USDA organic would add requirements about and expected.’’ 80 FR 23463. Several regulations. We are reopening the transitioning dairy animals to organic commenters disagreed with this proposed rule’s comment period for 60 production. Please refer to the proposed approach, and recommended that we days to give all interested parties an rule for information about AMS’ limit the movement of transitioned opportunity to comment on whether proposed changes, rationale, and animals to prevent organic producers or AMS should prohibit the movement of analysis. operations from continually transitioned cows in organic dairy AMS received over 1,500 public transitioning animals and/or continually production as part of the final rule. comments on the proposed rule. On sourcing off-farm transitioned animals. Comments previously submitted need October 1, 2019, we reopened the Based on these comments, we are not be resubmitted, as they are already comment period and received reopening the comment period to solicit incorporated into the public record and approximately 750 comments. These views on whether the final rule should will be fully considered in any future comments may be viewed at https:// prohibit organic dairy operations from final rule. www.regulations.gov under docket acquiring transitioned animals to DATES: For the proposed rule published number AMS–NOP–11–0009. We are expand or replace animals to produce on April 28, 2015 (80 FR 23455), send again reopening the comment period to organic milk. comments on or before July 12, 2021. solicit views on two additional issues Second, we are also seeking comment ADDRESSES: You may send comments on on the movement of the transitioned on whether the final rule should use the the proposed rule to the Federal animals and on the updated economic term ‘‘operation’’ to describe the eRulemaking Portal at https:// analysis of the proposed rule. regulated entity. While the proposed www.regulations.gov/. You can access rule used ‘‘producer,’’ several the proposed rule and instructions for I. Movement of Transitioned Animals commenters noted that the term submitting public comments by and Regulatory Framework ‘‘producer’’ can be interpreted in searching for document number, AMS– Origin of livestock in organic different ways, and inconsistent NOP–11–0009. Comments may also be regulations refers to the requirements interpretations may lead to inconsistent sent to Jennifer Tucker, Deputy for continuous organic management of application of the organic regulations. Administrator, National Organic animals that produce organic meat or Some certifier commenters stated that it Program, USDA–AMS–NOP, 1400 dairy products. In the 2015 proposed would be simpler to verify an Independence Ave. SW, Room 2642–S, rule, AMS sought comment on a operation’s eligibility (as opposed to a Ag Stop 0268, Washington, DC 20250– proposal to amend those requirements producer’s eligibility) to transition 0268. for dairy animals. The purpose of the animals. Additionally, the use of

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‘‘operations’’ would align the proposal update those analyses with more current operations found that the interpretation with the rest of the USDA organic information. We have updated the and implementation of the origin of regulations and the existing framework analyses to reflect more current livestock requirements differed across for certification and oversight. information about the dairy market, producers and certifying agents. As a If these provisions are implemented, including the number of certified result, organic milk producers may have existing certified dairy operations that organic operations and the number of faced materially different organic purchase animals, individually or as an organic dairy animals. This updated production requirements based on their entire herd, would not be allowed to information revises the estimated costs particular certifier’s interpretation of the purchase any transitioned animals for of the proposed rule ($488,000– National Organic Program’s (NOP) organic milk production beginning on $1,462,500) compared to the estimated origin of livestock requirements. AMS the compliance date. They would be costs ($288,000–$935,000) in our agrees with OIG’s recommendation that able to purchase and sell only livestock analysis published in 2015. The analysis the regulations should be revised to that had been under continuous organic below also includes updated clarify the origin of livestock management from the last third of information on the distribution of dairy requirements and ensure consistent gestation. New operations would have farms, dairy farm practices, and the application of the requirements by only one opportunity to transition in market for dairy products. We also certifying agents. non-organic animals into the operations. discuss public comments on those prior As described at the beginning of this Those transitioned animals could then regulatory analyses. SUPPLEMENTARY INFORMATION section, be sold to other operations, but only as Need for the Rule AMS published in 2015 a proposed rule non-organic. Once sold, those animals to revise the origin of livestock would not be eligible to produce organic AMS determined that the USDA regulations. The public comments milk. organic regulations for sourcing dairy received on the proposed rule in 2015 In addition to comments on the animals and managing breeder stock and during the reopened comment provisions above, AMS is interested in require additional specificity to ensure period in 2019 indicate there remains a comments on the following topics and organic dairy operations meet a need for rulemaking in this area. options: consistent standard. Interpretations of Of the comments received by AMS on 1. Implementation timeframe. AMS these regulations have differed between had proposed that all requirements be the 2015 proposed rule, a large number certifying agents, and the different were submitted by producers and implemented upon the effective date of interpretations have led to widely a final rule, with an exception for any consumers of organic dairy products divergent practices by organic dairy and groups representing producers and transition that was already approved by operations for sourcing replacement a certifying agent. AMS requests consumers. These commenters generally dairy animals. AMS proposes revising expressed a desire for AMS to establish comments about whether an the regulations to ensure the USDA implementation timeframe is necessary and enforce clearer rules for organic organic regulations are administered dairy production. They expressed that for organic dairies to comply. If one is and enforced in a clear, uniform, and needed, AMS requests comments on organic dairies should raise animals equitable manner, and to address organically from birth and not be how long this implementation period inconsistencies determined in the 2013 should be and why. allowed to cycle animals in and out of USDA Office of Inspector General (OIG) organic production (i.e., by continually 2. Accuracy of the estimates in the Audit.1 Furthermore, AMS expects that Regulatory Impact Analysis (RIA)/ transitioning animals). increased clarity will support trust in NOP’s experience is that because Regulatory Flexibility Analysis. The the USDA organic seal by assuring cost estimates presented in this notice organic products cannot be readily consumers that organic dairy products distinguished from nonorganic products are based on USDA and industry data. meet a consistent standard, a stated AMS requests feedback on the based on sight inspection, buyers rely purpose of the Organic Foods on process verification methods to assumptions related to costs and Production Act (OFPA) of 1990 (7 benefits, with supporting information ensure that organic claims are true. U.S.C. 6501). Within the economics literature, organic (data and sources) where available. In a 2006 final rule related to this 3. Exceptions to the one-time food products are ‘‘credence goods,’’ or issue (June 7, 2006; 71 FR 32803), AMS allowance requirement. AMS has not goods with characteristics that are recognized that the regulations allowed proposed exceptions to the one-time valuable but are difficult to verify, both different methods for replacing organic transition requirement, but the current before and after purchase.234 Foods dairy animals depending on how the regulations permit temporary variances certified under USDA’s NOP, including producer transitioned to organic in some scenarios (§ 205.290) and allow milk, have a common standard that production. AMS further stated that, for re-transition following Federal or specifies production practices, such as given the almost 13,000 comments on State emergency treatments (§ 205.672). dairy herd pasture requirements, the 2006 proposed rule (71 FR 32804), AMS seeks comments on whether the permitted feeds, and permitted use of the issue was a significant concern of rule should include any additional antibiotics and hormones, that cannot the organic community, including exceptions to the one-time transition organic dairy producers, certifying requirement for scenarios where the 2 Caswell, Julie A. and Eliza M. Mojduszka. 1996. agents, trade organizations, and current regulations would not apply, ‘‘Using Informational Labeling to Influence the consumers. and if so, what scenario(s) would Market for Quality in Food Products.’’ American The July 2013 OIG audit also Journal of Agricultural Economics. Vol. 78, No. 5: warrant an exception. identified a need for this rulemaking, 1248–1253. 3 II. Regulatory Impact Analysis/ Zorn, Alexander, Christian Lippert, and Stephan and AMS concurred with this finding. Dabbert. 2009. ‘‘Economic Concepts of Organic Regulatory Flexibility Analysis The OIG audit of organic milk Certification.’’ Deliverable 5 of the EU FP7 Because the Regulatory Impact CERTCOST Project: Economic Analysis of 1 The July 2013 OIG audit report on organic milk Certification Systems in Organic Food and Farming. Analysis and the Regulatory Flexibility operations may be accessed at the following 4 Michael Darby and Edi Karni, ‘‘Free Analysis for the proposed rule were website: http://www.usda.gov/oig/webdocs/01601- Competition and the Optimal Amount of Fraud’’ completed in 2015, we decided to 0002-32.pdf. Journal of Law and Economics 16(1973)1:67–88.

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be independently verified by farms maintaining cows and heifers and crops and livestock. Additionally, we consumers. does not include quantitative estimates used the Organic Trade Association’s When producing goods with credence for non-bovine dairy farms that (OTA) 2019 Organic Industry Survey, characteristics, producers face a moral maintain sheep and goats. AMS does conducted by the Nutrition Business hazard problem stemming from their not expect the rule would have a Journal, to summarize market incentive to forego taking costly actions substantial economic impact on those information and trends within the or investments associated with the label specific sub-sectors for the following organic industry.9 Also, AMS requested claim if handlers or consumers have no reasons: Goat does and sheep ewes are an organic dairy farm special tabulation way of verifying the production process able to produce milk earlier than cows, from the National Animal Health (i.e., asymmetric information). In so the potential cost-savings for non- Monitoring System (NAHMS) Dairy providing guidance to Federal agencies bovine dairy farms to continually source 2014 report collected by USDA’s undertaking rulemaking, OMB Circular transitioned animals (vs. animals under Animal and Plant Health Inspection A–4 cites asymmetric information as a organic management from the last third Service.10 source of market failure and as a of gestation) is small compared to that A final source of data is the NOP list potential justification for regulation. for bovine dairy farms. For this reason, of all certified operations included in Lassoued and Hobbs (2015) further the practice of continually adding the Organic Integrity Database. In emphasize the role of trust in the transitioned animals to organic non- January of each calendar year, every institutions and brands that verify bovine herds is likely less prevalent USDA-accredited certifying agent is credence good attributes as being than with organic bovine herds. These required to submit an annual list of the essential for developing the consumer operations also make up a relatively 5 operations it certifies to NOP (7 CFR confidence that drives brand loyalty. small portion of the organic dairy 205.501(a)(15)(ii)). NOP consolidates AMS developed the 2015 proposed industry. The Organic Integrity this information into a public, rule in the context of maintaining trust Database 6 of certified organic searchable online database.11 in the NOP label, as it pertains AMS used operations includes 56 dairy goat information from this database to cross- specifically to organic dairy farms and operations and 5 dairy sheep operations. to organic farms and organic handlers/ check NASS data on the number of AMS used multiple data sources to processors generally. AMS anticipates organic dairy operations. describe the baseline and build that rulemaking on this topic will quantitative estimates. The first source The Organic Dairy Market—Sales and support both producer and consumer Number of Operations confidence in the organic label by is the Agricultural Resource reducing major inconsistencies in Management Survey (ARMS), which is According to the OTA Industry production practices across organic maintained by USDA’s Economic Survey, U.S. organic food, fiber, and dairies. Research Service (ERS) and includes agricultural product sales were over questions about dairy farm cattle $55.0 billion in 2019, up 5 percent from Baseline purchases, restocking rates, and organic 2019.12 Organic dairy and eggs is the A final rule would specify the status.7 In 2016, ERS conducted a third largest sector in organic retail food conditions under which operations can supplemental ARMS that focused on sales (13 percent), after fruits and transition non-organic animals to organic dairy operations. AMS worked vegetables (36 percent) and beverages organic for the purpose of milk with ERS to analyze recent ARMS data (14 percent). Sales of organic dairy production. Current dairy production and develop an estimation of organic products, including milk, cream, yogurt, and husbandry practices provide dairy production practices and costs for cheese, butter, cottage cheese, sour important context for the baseline and this rule. cream, and ice cream, reached almost cost analysis. For a general description Other sources of data are the National $5.8 billion in 2019. Table 1 shows the of replacement animal production, see Agricultural Statistics Service’s (NASS) organic dairy market characteristics by ‘‘Overview of Organic Dairy 2016 Certified Organic Production subcategory. In 2019, organic dairy saw Production’’ in the 2015 proposed rule Survey and 2017 Census of total sales growth of 2 percent, with the (80 FR 23468). Agriculture,8 which include State-level fluid milk growing 3 percent, yogurt The baseline presented below focuses data on production, herd sizes, output, growing 1 percent and cheese falling 1 on production practices of bovine dairy and sales for organic and non-organic percent.

TABLE 1—ORGANIC DAIRY MARKET—RETAIL SALES BY SUBCATEGORY

Percent of b Organic 2019 Sales Avg. markup c Subcategory ($ M) 2019 Growth organic dairy (%) markup sales a ($ M)

Milk/Cream ...... $3,394 2.9 58.8 51 $1,146 Yogurt d ...... 1,260 0.5 21.8 10 115 Cheese e ...... 572 ¥1.4 9.9 75 245 Butter/Cottage Cheese/Sour Cream d ...... 425 0.3 7.4 76 184

5 Lassoued, R. and J.E. Hobbs (2015) ‘‘Consumer http://www.ers.usda.gov/data-products/arms- 10 The 2014 Dairy NAAHMS report may be found Confidence in Credence Attributes: The Role of farm-financial-and-crop-production-practices.aspx. at the following link: http://go.usa.gov/xKfEh. Brand Trust’’ Food Policy 52:99–107. 8 The USDA NASS surveys may be found at the 11 Certifying agents are required to send 6 Certifying agents are required to send following link: https://www.nass.usda.gov/Surveys/ information on certified operations yearly. Current information on certified operations to AMS Guide_to_NASS_Surveys/Organic_Production/. and historical data may be accessed through the annually. Current and historical data may be 9 OTA/Nutrition Business Journal, 2019 Organic Organic Integrity Database at the following link: accessed through the Organic Integrity Database at Industry Survey. Nutrition Business Journal the following link: https://organic.ams.usda.gov/ conducted a survey between January 1 and April https://organic.ams.usda.gov/Integrity/. Integrity/. Accessed 11/21/2019. 25, 2019, to obtain information for their estimates. 12 Organic Trade Association (OTA)/Nutrition 7 The ERS ARMS survey information may be Over 200 organic firms responded to the survey. Business Journal, 2020 Organic Industry Survey found at the following link: Available online at https://ota.com/resources. (pp. 4, 80).

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TABLE 1—ORGANIC DAIRY MARKET—RETAIL SALES BY SUBCATEGORY—Continued

Percent of Organic 2019 Sales Avg. markup b markup c Subcategory ($ M) 2019 Growth organic dairy (%) sales a ($ M)

Ice Cream ...... 118 1.3 2.0 100 118

Total ...... 5,769 1.7 100.0 47 1,808 a The Organic Trade Association’s 2019 Organic Industry Survey (p. 80) included eggs as a subcategory for its summary on organic dairy sales, but we have excluded the data on eggs from this table. b USDA’s AMS weekly reported prices in the 2020 weekly dairy retail report based on the first weekly report in January, April, July, and Octo- ber. These reports are available at: https://www.ams.usda.gov/market-news/dairy. Average prices of product categories are averages across the four periods weighted by store counts. Markups are calculated as the: ((Organic Price¥Conventional Price)/Conventional Price). c The dollar value of the organic markup for each category is: (Organic Sales × Markup)/(1+Markup). d The yogurt and butter, sour cream and cottage cheese markups are respectively the average of the markups of four yogurt products and but- ter, sour cream and cottage cheese products, weighted by counts of stores advertising organic products. Cheese markups are for natural vari- eties in 8 oz. blocks.

Table 1 also includes markups in the operations.16 Of these operations, 49 milk cows owned by organic dairy farms prices of dairy products marketed as operations were identified as operations averaged 116 head in 2011, 106 head in organic versus conventional (or milking ‘‘goats’’ or ‘‘sheep’’ (and not 2015, and 109 head in 2016. In contrast, ‘‘nonorganic’’) products. For dairy bovine animals). An additional 286 NASS’ Census of Agriculture showed products, the average organic markup were breeders, replacement heifer the number of milk cows for was 47 percent and totaled $1.8 billion operations, or cull cattle handlers, all of conventional dairy farms averaged 144 in value.13 In market equilibrium, this which did not indicate that they head in 2012 and 175 head in 2017. markup reflects both the higher costs of produced milk. In all, the 3,181 farms in Organic dairy farms also have lower organic production and the value this database are likely to produce yields, on average, than conventional consumers place on organically labeled organic milk and be affected by the rule dairy farms. The 2016 Survey of Organic products and their various underlying through their organic replacement heifer Agriculture showed that each organic attributes. While AMS does not have purchases. cow produces about 14,461 pounds of estimates of the specific values of each AMS decided to use the 2016 NASS milk annually, or 48 pounds per day attribute, the agency assumes that data for our analysis for the following over a 300-day lactation period. NASS adjustments to the organic production reasons. Primarily, the Organic Integrity production data for 2018 shows that standards that would reduce production Database does not track the number of across all operations (conventional and costs must be simultaneously weighed organic dairy cattle maintained by organic) average production is 23,149 against those adjustments’ potential to certified operations. Absent information pounds of milk per animal annually, or affect markups. indicating a higher population of dairy 77 pounds per day over the same 300- The 2016 NASS Organic Production cattle (compared to NASS data), an day period. Despite higher production Survey estimated that U.S. had upward adjustment of farm numbers costs and lower yields, organic dairy approximately 2,559 certified and alone, without an adjustment of animal farms can be economically viable exempt organic dairy farms that milked numbers, has little effect on our through the price markups they receive a peak of 279,021 cows in 2016.14 These analysis. Secondly, the NASS survey of over conventional milk and milk organic dairy farms had milk sales of organic production records the number products. Table 1 shows that the average nearly $1.4 billion in 2016. Despite the of organic dairy cows even if it does not markup for organic milk products more recent sales declines, total organic necessarily classify the farm owning averaged 47 percent at the retail level. milk production in the United States them as a dairy farm. This could Based on the 2016 NASS Survey of increased to 4.0 billion pounds in 2016, undercount the number of operations, Organic Production Data, Table 2 shows representing an 18.5 percent increase in but not the number of organic dairy that the highest concentration of organic production from 2015 and 44.5 percent animals. Lastly, the Organic Integrity dairy farms is in the Northeast and Upper Midwest regions,18 increase since 2011. In that same time Database may overcount the number of but that large organic dairy farms in California and frame, the number of certified organic operations that are actively engaged in Texas represent a large share of output. farms grew 1 percent over 2015 (2,531 dairy farming because mixed use farms The five States with the largest number farms in 2015) and grew 41 percent may obtain additional certifications if of certified organic dairy farms compared to 2011 (1,812 farms in 2011). they intend to handle organic dairy (Wisconsin, Pennsylvania, New York, In comparison, the Organic Integrity cattle but are not actively engaged in 17 Ohio, and Indiana) accounted for 65.7 Database 15 identified approximately it. percent of the total farms. However, 3,516 organic livestock operations Organic Dairy Farms—Characteristics those States represented less than 30 certified for production in January of and Distribution percent of national organic milk 2020 that included ‘‘dairy, milk, cow, Organic dairy farms are, on average, production. cattle’’ in their description of smaller than conventional dairy farms. By contrast, the West and South NASS’ Certified Organic Surveys Central regions accounted for the 13 National Retail Report—Conventional vs Organic—https://usda.library.cornell.edu/concern/ Agriculture show that the number of highest milk production per farm. The publications/000000043?locale=en. two highest organic milk producing 14 USDA NASS. 2017. Census of Agriculture— 16 Data was filtered for operations certified for States (California and Texas) 2016 Certified Organic Survey. Available online at: livestock scope with certified livestock or handling https://www.nass.usda.gov/Surveys/Guide_to_ products that include terms ‘‘milk’’ or ‘‘dairy.’’ 18 USDA’s Certified Organic Production Survey NASS_Surveys/Organic_Production/. 17 For instance, these operations may become available online at: https://www.nass.usda.gov/ 15 The Organic Integrity Database is available certified for dairy so that they can manage organic Surveys/Guide_to_NASS_Surveys/Organic_ online at: https://organic.ams.usda.gov/Integrity/. dairy animals under favorable market conditions. Production/.

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represented only 4.3 percent of total in the number of milk cows on dairy farm. ARMS and NAHMS data showed certified organic dairy farms, while farms. The Northeast and North Central similar patterns of size difference across producing 31.6 percent of the total regions average 58 head per farm; the regions. organic milk nationally. The survey also Southeast 112 head; the West 405 head, showed significant regional differences and the South Central 1,667 head per

TABLE 2—TOP STATES WITH ORGANIC DAIRY FARMS COMPARED TO PRODUCTION [2016]

Number of Percent of Milk Percent of organic U.S. organic production U.S. milk dairy farms dairy farms (pounds) production

United States ...... 2,559 100 4,034,989,854 100 California ...... 104 4.1 795,750,804 19.7 Texas ...... 6 0.2 481,392,352 11.9 Wisconsin ...... 453 17.9 370,627,696 9.2 Oregon ...... 46 1.8 342,534,830 8.5 New York ...... 471 18.6 327,387,420 8.1 Pennsylvania ...... 300 11.9 196,641,598 4.9 Vermont ...... 172 6.8 171,463,088 4.2 Washington ...... 41 1.6 128,685,429 3.2 Minnesota ...... 108 4.3 127,828,496 3.2 Ohio ...... 212 8.4 119,264,078 3.0 Idaho ...... 20 0.8 118,291,465 2.9 Indiana ...... 225 8.9 113,879,386 2.8 Michigan ...... 70 2.8 65,950,978 1.6 Iowa ...... 74 2.9 46,847,454 1.2 Maine ...... 63 2.5 44,456,548 1.1

The Organic Dairy Market— small and medium operations (26.0 and (excess) replacement female animals Replacement Animals 26.3 percent, respectively) than on large should allow organic dairy operations to Cull and Mortality Rates operations (29.7 percent). expand the number of animals in their The same surveys provide herds should they wish to expand. This Operations source replacement information about the deaths of animals scenario has not considered that animals from on- and off-farm sources to on dairies. Overall, annual mortality producers may choose to breed with replace animals that are sold, die, or are rates were 7.8 percent for un-weaned sexed semen which will increase the intentionally removed (‘‘culled’’). The heifers, 1.8 percent for weaned heifers, number of female offspring available to APHIS NAHMS surveys 19 in 2007 and and 5.7 percent for cows (2007 survey). the dairy farm. 2014 provide data on how many In 2014, NAHMS identified that about 5 Sourcing Organic Replacement Animals animals are culled (removed) from U.S. percent of adult organic dairy cows die dairies annually and the reasons for on the farm (compared to 21 percent of Most organic dairy farms replace culls their removal. Most dairy cows were adult organic cows that were removed and deaths with replacement heifers removed for udder problems or for other reasons). These numbers were that are born and raised on the farm. reproductive problems, followed by roughly consistent with the 2007 report. The 2014 NAHMS data reports that 96.5 20 lameness and poor production. In the Between culling and mortality, a dairy percent of organic replacement heifers 2007 APHIS NAHMS survey of dairies, farm would need to raise or purchase are born and raised on the organic the national rate of permanently females that represent about 30 percent operation. An additional 2.6 percent of removing a dairy animal from a farm (23.6 percent culled plus 5.7 percent the replacement heifers are born on the (excluding cows that died) was 23.6 deaths) of the farm’s herd size to operation and are subsequently raised 21 percent while the 2014 survey found maintain its size. As a lactating dairy off the operation before returning to the 22 a rate of 28.4 percent. The 2014 herd (cattle) typically calves about 50 operation. The remaining 0.9 percent of NAHMS survey found that 21 percent of percent female offspring each year, the replacement females are born off the adult organic cows were removed from overall dairy herd should have enough operation and are presumably the organic herd. These figures include replacement females to replace culled purchased from other operations. animals that are sold as replacement animals and animals that die. This The 2016 ARMS data also provides females to other dairies. The 2014 conclusion considers downward information about how dairies source survey found a lower percentage of adjustments for mortality (using 2007 replacement animals. Overall, ARMS cows were permanently removed on NAHMS rates noted above of 7.8 data indicates that in 2016, the average percent and 1.8 percent) and additional organic dairy farm milked 102.7 cows 19 USDA APHIS. NAHMS Dairy, 2007, Part I: 23 and added 43.0 replacement animals of Reference of Dairy Cattle Health and Management reduction for culling. The additional Practices in the United States, 2007. This survey all types. Of those replacements, 93.8 included both nonorganic and organic dairy 23 As an example, a 100-cow lactating dairy herd percent (40.35 head) were born on the animals. Available online at: http://go.usa.gov/ would produce about 50 heifers annually (i.e., 50 farm (and owned continuously by it) xKfEh. percent of births). Considering this heifer group as 20 USDA APHIS. NAHMS Dairy 2007, 84. a single group, a 7.8 percent mortality rate would second year, this number could be reduced another 21 USDA APHIS. NAHMS Dairy 2007, 87. reduce the herd to about 46.1 animals by the end 1.8 percent (mortality rate for weaned heifers) to 22 USDA APHIS. NAHMS Dairy 2014, Report I: of year one (assuming a 7.8 percent mortality rate 40.7 animals. Assuming a further 10 percent Dairy Cattle Management Practices in the United over the entire year). Additionally, we assume a 10 reduction due to culls, the original 50-animal group States, 2014. Available online at: http://go.usa.gov/ percent cull rate could further reduce this to 41.5 may be reduced to 36.6 animals by the end of year xKfEh, 218. animals at the end of year one. By the end of the two.

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and 85.1 percent (36.62 head) were both provided survey data indicating the grow existing organic dairies. To born and raised on the farm. Based on proportion of sampled producers that mitigate potential and unforeseen 2,559 total dairy farms with a mid-point may be practicing continuous impacts, AMS proposes establishing a herd size of 267,523 reported in the transitioning. OIG found that out of a compliance date for this rule to allow Census of Agriculture, ARMS data sample of six of the top ten certifying animals in the middle of an approved indicates that 110,037 total heifers and agents that certify the most organic transition to complete the transition and milk cows (41.1 percent of the herd) dairy operations in the U.S., three produce organic milk. AMS received were added to operations in 2016.24 allowed continuous transitioning. many comments that supported this Purchased animals from off-farm approach during the 2019 comment sources included 4,325 milk cows (3.9 Regulatory Impact Analysis period. percent), 1,953 large heifers weighing Comments Received on Costs and Price of Replacement Animals more than 500 pounds (0.73 percent), Benefits and 559 small heifers weighing less than A commenter in 2019 disagreed with AMS specifically sought input from 500 pounds (0.2 percent). AMS’ estimate of a $1,300 cost Of the organic farms responding to the the public about the estimated costs and difference between transitioned animals 2016 ARMS, 8.7 percent reported benefits presented in the 2015 proposed and last-third-of-gestation organic purchasing dairy cows and 10.9 percent rule. We received 29 comments in 2015 animals. The commenter believed AMS’ reported buying replacement heifers. and 82 comments in 2019 that estimate was too high. The commenter Farms that purchased milk cows addressed our estimated costs and further explained that its ‘‘discussions purchased an average of 19 cows per benefits. We summarize and respond to with dairy auction sales barns that farm and those that purchased heifers these comments below. previously sold organic cattle do not bought an average of 7 head. Most Availability of Replacement Animals align with that value’’ and the most organic dairies also reported selling cull common response it received from cows (animals that are no longer In 2015, some comments noted that extension agents in the Northeast was productive for milk production and are organic heifer supplies were tight and that ‘‘demand and verified sales have all sold for beef), milk cows, and that the heifers for sale were not of but dried up for organic springing replacement heifers. Organic dairy consistently high quality. This led heifers.’’ farms sold an average of 1.6 milk cows commenters to believe the proposed AMS received many comments in and 1.3 replacement heifers with sales rule could curtail growth of existing or 2019 related to the cost difference for of replacement heifers exceeding new operations, restrict milk supply, raising heifers organically vs. purchases. Alternatively, the 2014 and raise consumer prices. Some nonorganically during the first 12 NAHMS data similarly show that the comments urged AMS to seek a months of life. One commenter found a average organic dairy farm added 39 consistent standard for all operations $469 average cost difference (organic replacements that were born on the while considering that operations may being more costly) per animal. Most operation and added to the milking herd need to grow to meet consumer demand. comments noted a cost difference from and purchased 7 replacements that were A comment in 2015 calculated that a $600 to $1,000 per calf, and some added to the milking herd. dairy could be expected to raise only comments noted a difference as high as Exact data on how many replacement enough of its own heifers to grow at an $1,300 per calf. Commenters tended to heifers bought were transitioned heifers annual rate of 5 percent, after use the difference in production costs to and how many were managed accounting for morbidity and culling. describe the financial disadvantage and organically from the last third of This commenter questioned AMS’ the harm to operations that source only gestation are not available. For this conclusion there would be an ‘‘ample last-third-of-gestation organic animals in reason, this RIA calculates costs for two supply’’ of organic heifers under the comparison to operations that conjectured values for the share of rule. The commenter estimated that the continually transition heifers to organic purchased replacements that are industry would take time to catch up production. transitioned heifers. Furthermore, AMS with the demand for organic (from last Commenters in 2015 and 2019 does not have aggregated data on what third of gestation) heifers. generally agreed that implementation of approach producers currently use when Other comments in 2015 argued that the proposed rule would result in purchasing replacement heifers. there was an adequate supply of organic greater demand for organic heifers and Therefore, we do not have data on how (last third of gestation) heifers available would likely increase the price of many producers are bringing heifers or that operations would raise and sell organic replacement animals. Many into organic production as nonorganic them if the price was higher and commenters viewed this scenario animals and transitioning them into reflected the cost of raising them. In favorably, as it would benefit organic organic (or purchasing animals 2019, commenters claimed there is a producers who sell last-third-of- transitioned on other organic surplus of organic (last third of gestation organic animals (as opposed to operations) versus sourcing and gestation) heifers available to meet heifer-raising operations selling managing animals as organic from the market needs and that there is an ample transitioned animals). last third of gestation. Excluding small supply of animals even if morbidity/ AMS response: AMS continues to heifers, the percentage of replacement mortality rates are high or heifer present the costs of the rule as a range heifers that are transitioned to organic selection is aggressive. No comments in based on different potential scenarios production is, at most, 1.7 percent.25 2019 claimed that organic heifer (see Table 4). We agree with comments AMS also notes that the OIG report supplies were constrained. that the price of organic heifers may AMS response: Based on our analysis increase, and we have estimated costs 24 The 2017 ARMS survey indicates that the of the comments received, AMS under two scenarios where the price of average organic herd size is 102.7 head while the continues to believe that sufficient heifers increases by $500 and where the 2016 Census of Organic Production indicates it is numbers of organic heifers (organically price does not increase. We estimate 104.5 (= 267,523 head/2,559 farms). 25 This percentage represents 0.75 purchased managed from last third of gestation) that the price of an organic (last third of (large) heifers divided by 43.0 replacements (2016 would be available after rule gestation) heifer is $2,000 and up to AMRS data). implementation to maintain and/or $2,500 if increased demand drives

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prices upward. This represents at least was $57.8 million in 2016.26 Based on animals and a corresponding drop in a $1,000 premium for organic (last third these figures, AMS estimates that a final prices for these animals. of gestation) animals over transitioned rule would increase producer costs by AMS response: AMS recognizes that animals. The estimated difference seems 1.3 to 2.5 percent and retail costs by 0.4 the organic dairy market in 2015 to agree with comments that production to 0.8 percent. Price effects will depend differed from the current organic dairy costs for these animals are $600 to on the specific products being market. Our calculation of costs for this $1,300 higher. We recognize that this considered. AMS first-of-the-quarter proposal is higher than those calculated price estimate may be high and thus the price reports indicate that a half gallon in 2015 because the cost calculation is result might be considered an upper of organic milk has an average retail based, in part, on the number of organic bound of the estimated costs. price of $3.98. Based on our dairy operations and total organic herd calculations, a final rule might raise this size. These numbers have both Effect on Consumer Milk Price price by 2 to 3 cents. AMS does not increased since 2015, so the estimated A commenter in 2015 estimated the believe that price effects of this cost is higher. rule would increase the cost of magnitude are likely to limit industry Costs and Benefits (General) producing organic milk by 3.7 to 6.0 growth or noticeably affect demand. A commenter in 2019 disagreed with cents per half gallon (0.87 percent to Number of Transitioning Animals 1.42 percent, respectively) and that the AMS’ cost analysis in the proposed rule. increase would be passed to consumers One commenter in 2015 estimated It stated that the cost analysis ‘‘fails to and negatively affect consumer demand. there were 60,000 conventional animals capture the cost inequities of not However, AMS also received comments transitioning to organic production on implementing the proposed rule,’’ and in 2015 from organic milk consumers new dairy farms and established dairy specifically points to its ‘‘failure to that supported the proposed rule even farms. The commenter predicted this distinguish production costs between recognizing the price of milk could could lead to an oversupply of milk and organic and transitioned heifers.’’ increase. Another comment in 2015 decrease in milk price (income for the Without this information, the noted that if supply of organic milk dairy farm). Another commenter in 2019 commenter argues ‘‘neither the agency were to become very restricted under believed that ‘‘tens of thousands’’ of nor stakeholders can understand the the new requirements, retail prices animals had transitioned since 2015. true cost, and true harm, of could increase to a point where AMS response: AMS recognizes that implementing or not implementing the proposed rule.’’ Furthermore, the consumer demand would flatten or even we do not have precise data on how many animals are transitioned on an commenter calculated the harm to decrease. annual basis by certified organic operations that source only last-third-of- In 2019, stakeholders were more operations. Our experience indicates gestation organic animals using the concerned with how consumer milk that most organic dairy farms do not difference in production costs for prices negatively affect organic dairy continually transition animals. transitioned animals and last-third-of- producers than how they affect However, because of the lack of precise gestation organic animals. The consumers. Comments frequently numbers available, we estimate that commenter estimated that 25 percent or discussed the idea that there is an transitioned animals comprise 25 50 percent of all culled organic dairy oversupply of organic milk currently percent (low end) to 50 percent (high animals are replaced with transitioned ‘‘flooding the market’’ that are driving end) of all purchased replacement animals and calculated competitive consumer prices down. animals. AMS did not receive concrete harm of $9.29 million to $18.58 million AMS response: Table 1 figures data from comments to support annually ($469 multiplied by 25 percent indicate that the retail markup of alternative figures. to 50 percent of all culled animals using organic milk products over conventional a cull rate of 28.4 percent). milk products is 47 percent. The AMS Changes in Dairy Market Since 2015 AMS response: The commenter organic dairy report for February 8th to In 2019, many comments noted that estimates that the competitive harm 12th, 2021, indicated that the 2020 the organic dairy industry had changed from the current enforcement practice of average (farm-level) organic milk pay considerably since AMS published the allowing transitioned animals is $9.29 price was $31.55 per hundredweight proposed rule in 2015. Primarily, million (under the 25 percent scenario) while the USDA World Agricultural commenters noted a decline in and $18.58 million (under the 50 Demand and Supply Estimates for April consumer demand for organic milk and percent scenario). These estimates are 2021 indicate that the 2020 (farm-level) increased availability of organic milk based on the commenter’s finding that all milk price was $18.32 per and organic dairy cows. Some a conventional heifer costs $462 less to hundredweight. Together these values comments noted that fewer operations raise and that organic farms require indicate that the farm-level organic are transitioning to organic production 79,242 replacement heifers annually markup is 72 percent. The ERS farm due to limited opportunities to secure a based on a 28.4 percent cull rate on the share of the retail price for the milk and contract with a milk handler or because 279,021 (head) total U.S. organic herd. dairy basket in 2018 was 28 percent. the price premium for organic AMS agrees with the commenter’s Collectively, this implies that the farm production is no longer an incentive to general concern that organic dairy farms share of the retail price for organic milk transition. Some 2019 comments noted need to replace a substantial share of is 32 percent. that the cost of the rule would be less cows each year and that the uneven Table 4 shows that the total costs of than AMS estimated in 2015 due to application of rules regarding transition this proposal to the organic milk increased availability of organic (from of heifers creates artificial cost producers net of transfers would be last third of gestation) replacement disparities. AMS uses the price $1,462,500 under our 50 percent difference for purchased replacement transitioning scenario and $731,000 26 Given the recency of the data and the relatively heifers (transitioned vs. organic from under our 25 percent transitioning low inflation rate throughout, we do not adjust for last third of gestation) as its estimate of scenario discussed further below. The inflation in our estimates. We note that ARMS data and the Census of Agriculture Data both reflect the per animal increase in costs for Census of Organic Agriculture indicates 2016 data indicating no need to adjust for inflation dairy farms that have used transitioned that farm-level organic milk revenue in calculating markups. animals. AMS recognizes that this does

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not account for increased costs to production for the first time would not possible increase for the price of organic operations that might maintain incur new costs during the 12-month animals to calculate the maximum ownership of offspring that are born on- transition period; they may transition expected costs. Below we discuss the farm, subsequently removed from animals on a one-time basis under the data and calculations in detail. organic production, and then proposed rule. The ARMS survey includes farm-level transitioned back into organic Estimated Costs for Dairies data on purchases and sales of heifers production. We understand that most weighing more than 500 pounds, a certifiers do not interpret the current The proposed rule creates two costs category that explicitly includes sales of for organic dairy farms. First, dairy regulations to allow this practice. For springers.27 While the ARMS survey farms that regularly transition heifers or this reason, AMS believes that applying does not identify whether purchased regularly purchase transitioned the cost differential to replacement heifers have been organic from birth or replacement heifers after their initial heifers that are both purchased and have transitioned to organic status, it transition to organic would be required unpurchased (i.e., owned) would likely does identify whether the farms either to purchase higher-cost organic overstate the cost of the rule. However, themselves are certified or transitioning (from last third of gestation) AMS seeks data from industry regarding to organic status. Since all cattle sold by replacement heifers or to raise their own the extent to which unpurchased heifers organic dairies are themselves organic replacement by raising organic calves to are transitioned to inform our cost and all cattle sold by non-organic maturity. This analysis assumes that calculations. dairies are conventional, this analysis transitioned animals are currently sold As described in our consideration of assumes that the difference in the large at a discount compared to organic (from regulatory alternatives, AMS expects heifer sales prices for organic or the last third of gestation) replacement that purchases of replacement heifers transitioning farms and other farms animals. that are transitioned animals would reflects the difference in costs for those increase if AMS allowed this practice Second, by raising the demand for organic replacement heifers, the animals. This analysis estimates costs (Alternative A). Additionally, dairy under the alternative assumptions that operations utilizing heifer-raising proposed rule may raise the price of organic replacement heifers if either 25 or 50 percent of all purchased operations while retaining ownership heifers are transitioned heifers. may switch to operations that use operations currently selling organic conventional practices and then (transitioned) replacement heifers We used 2016 ARMS data to estimate transition the animals. Table 3 shows cannot comply with the proposed the number of replacement animals that only 11 percent of operations requirements and operations that sell purchased by organic operations. Table purchase replacement heifers. The organic (last third of gestation) 3 provides the average numbers and uneven application of the current rule replacement heifers cannot easily prices of large heifers bought and sold suggests that a smaller share of increase offerings. While this price by organic or transitioning farms, producers is benefiting from the cost increase is likely to be small, it would divided into four different size advantage of transitioned heifers, at a raise costs to any organic dairy farm that categories, along with figures for all level higher than that suggested by the is a net buyer of organic replacement organic or transitioning farms and all average number of head purchased. heifers, regardless of whether it other non-organic farms. Compared with continually transitions animals or their non-organic counterparts, organic Costs of Proposed Rule purchases transitioned replacement and transitioning dairy farms are The proposed rule would likely heifers. This same price effect, however, smaller in herd size, less likely to increase production costs on organic would create an offsetting benefit to any purchase large heifers as replacements, livestock and dairy operations that dairy farm that is a net seller of organic and more likely to sell large heifers. On currently continually transition replacement heifers. average, organic dairies purchase nonorganic animals and/or operations AMS estimates the costs of the replacement large heifers at a rate of that source transitioned dairy animals as proposed rule below by estimating the 0.73 percent of their total herd size (or replacements. Additionally, any dairy total number of replacement animals 0.75 head) and sold large replacement that purchases organic heifers may pay purchased by U.S. organic dairy cattle heifers at a rate of 1.2 percent of their higher prices for organic animals due to operations annually. We then estimate total herd size (or 1.27 head). increased demand, but organic the percentage of all purchased animals However, only 10.9 percent of dairy operations selling replacement heifers that does not meet the requirements of farms purchased large heifers so that the would benefit from any higher prices. the proposed rule (i.e., the percentage of average farm purchasing heifers bought We assume that farms that exclusively animals bought by organic operations 6.9 head. Based on an average mid-point raise their own organic replacement that are not organic from the last third herd size of 267,523 milk cows,28 all heifers and manage those animals of gestation). Due to the unavailability organic dairies purchase 1,953 large organically from birth would not incur of precise data, we estimated a range of heifers annually. Rounding the large additional costs under the proposed possibilities (25 percent to 50 percent of heifer purchase figure to 1,950, these rule. Similarly, dairy farms that send all purchased animals). To calculate organic heifer calves to other certified costs, we then multiply the number of 27 A springer is a heifer (i.e., a female cow that organic operations to have the animals animals by the price difference between has not previously calved) that is 7 to 9 months continuously managed as organic (for organic (from the last third of gestation) pregnant and will begin producing milk within 0 some period of time before returning to and nonorganic heifers (we use to 2 months. 28 The mid-point herd size is the average of the the farm) would not incur additional nonorganic heifer prices as a substitute Jan 1 and Dec 31 herd size for 2016. NASS Organic costs. Finally, nonorganic dairy for transitioned animals in the absence Production Survey. It is slightly less than peak operations converting to organic of that data). Finally, we considered a heard size of 279,021.

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figures imply that 488 purchased heifers gestation) under our 25 percent heifers under our 50 percent are transitioned (rather than managed assumption, and 975 are transitioned assumption. organically from the last third of

TABLE 3—HEIFER PURCHASE AND SALES PRICE AND RELATED STATISTICS BY DAIRY FARM SIZE AND ORGANIC STATUS [ARMS]

1–49 49–99 100–199 200+ All

Organic and Organic Transitioning Farms

Number of Farms in ARMS Survey ...... 144 114 42 32 ...... Largest Number of Cows Milked ...... 33 68 132 499 103 L. Heifers Sold (Head) ...... 0.31 0.84 0.60 8.02 1.27 Sold L Heifers ($/Head) ...... $1,350 $1,993 $2,111 $1,918 $1,887 % of Farms Purchasing L. Heifers ...... 8% 16% 10% 7% 11% Purch. L. Heifers as a % of Herd ...... 1.5% 1.0% 1.3% 0.2% 0.7%

Other Farms

L. Heifers Sold (Head) ...... 1.14 1.37 1.73 9.68 5.5 Sold L Heifers ($/Head) ...... $600 $1,161 $1,304 $989 $1,012 % of Farms Purchasing L. Heifers ...... 3.3% 7.2% 4.8% 12.1% 3.3% Purch. L. Heifers as a % of Herd ...... 0.2% 1.0% 0.8% 3.2% 2.9%

We also used the 2016 ARMS data to collected by AMS in November of 2019. price by $500, or 25 percent,30 to estimate the price difference between These data show that bred heifers in the $2,500. In this case, the total cost of organic replacement animals and third trimester (i.e., springers) of purchasing replacement heifers by nonorganic replacement animals. Table supreme and approved quality sold for organic dairy farms would be $4.875 3 shows the price at which organic and $1,045. million per year (1,950 replacements transitioning dairies sold large Additionally, the assumptions are animals purchased from off farm at replacement heifers. Because the price supported by public comments that $2,500 per head). This would be the of transitioned heifers compared to last- indicate it costs between $600 and new total cost of purchasing organic third-of-gestation organic heifers is not $1,300 more to raise an organic calf than heifers rather than the additional cost of available, our analysis uses the cost of a nonorganic calf. purchasing organic heifers, which is non-organic large heifers as a substitute. The increased demand for 975 considerably less.31 This is likely to exaggerate the cost additional organic (from last third of Table 4 shows the estimated costs to differential. The large heifer selling gestation) replacement heifers under the and intra-industry transfers between price of $1,887 at organic and 50 percent transitioning assumption (or organic dairy farms purchasing organic transitioning dairy farms was $865 more 488 additional organic replacement heifers under alternative assumptions than the selling price of $1,012 at non- heifers under the 25 percent on price response and replacement organic farms. Across individual farm transitioning assumption) is not heifer purchases that would follow the size categories, however, this difference expected to lead to a large increase in proposed rule. Industry transfers are in prices between organic and non- their price because many of the key costs to a set of dairy farms that are organic selling prices varied across size inputs to producing those organic exactly offset by benefits to another categories, ranging from $750 (farms replacement heifers can be readily dairy farm. In the case of the proposed with 0–49 cows) to $937 (200+ cows). expanded. These inputs include organic rule that would affect organic dairy Based on the data, our analysis assumes heifer calves, additional organic feed, farms, such transfers would occur that before the imposition of any of the and additional organic pasture land. because farms that are currently net proposed changes, a transitioned heifer Because heifer calves are often sold for sellers of organic heifers see sales costs $1,000 and an organic heifer costs meat rather than milk production, the revenue increase from price increases $2,000 so that the difference in price number of these animals that might be for organic heifers should the rule be between the two animal types is slightly re-directed into milk production is far enacted, even as net buyers of organic higher than the largest difference less than their total availability, a cattle see their costs increase. If the observed in the data. situation providing a strong check on price of organic heifers does not price increases for that input. Moreover, Related data and public comments increase, then no transfer would occur. the additional organic pasture and AMS expects that organic dairy farms support these assumptions on price additional feed required for 975 relationships. The approximately $1,000 will purchase 1,950 replacement heifers additional organic replacements are per year based on our analysis of ARMS price of non-organic bred heifers (our relatively small compared to the substitute for the price of a transitioned data. If the price of organic dairy heifers existing requirements for the 103,000 were to be unchanged following the animal) is supported by livestock heifers currently retained by organic auction market prices at five sites 29 rule, our analysis finds that total costs farms for their own replacements. would increase by $975,000 per year However, this analysis assumes that 29 This includes data collected in the AMS the increased demand for organic Livestock and Replacement Cattle Reports reported 30 A 25 percent price increase resulting from a 50 at https://www.ams.usda.gov/market-news/feeder- replacement heifers pushes up their percent increase in quantity supplied is consistent and-replacement-cattle-auctions for the following with an elasticity of supply of 2. five auctions: Mid-Georgia Livestock, Jackson, GA; Holland Sales Stables, New Holland, PA; and 31 These costs reflect only those for dairy cattle. Empire Livestock, Cherry Creek, NY; Mammoth Toppenish Monthly Dairy Replacement Sale, Costs for purchasing dairy sheep and goats are not Cave Dairy Auction, Smiths Grove, KY; New Toppenish, WA. included in this analysis.

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under the assumption that 50 percent of replacements are transitioned, our purchased replacements are purchased replacement animals had analysis finds that total costs are transitioned, our analysis finds that total been transitioned animals, or costs $732,000 (reflecting 488 new organic costs would be $1,462,500 (reflecting increase by $488,000 under the replacement heifers purchased for 975 new organic replacement heifers assumption that 25 percent of $1,500 over the conventional price) and purchased for $1,500 over the purchased replacement animals had transfers are $731,000 (reflecting 1,462 conventional price) and transfers would been transitioned animals. In these previously purchased organic heifers be $487,500 (reflecting 975 previously cases, there are no transfers. If the price purchased at price $500 higher). purchased organic heifers purchased at of organic dairy heifers rises to $2,500 If the price of organic dairy heifers price $500 higher). This information is and 25 percent of purchased rises 50 percent, and 50 percent of presented in Table 4 below.

TABLE 4—ESTIMATED COSTS UNDER ALTERNATIVE ASSUMPTIONS FOR PRICE RESPONSE AND THE QUANTITY OF TRANSITIONED ANIMALS PURCHASED BY CERTIFIED ORGANIC OPERATIONS ANNUALLY

Assumptions regarding . . . Estimated additional Estimated costs net of transfers . . . Price response . . . Transitioning heifers transfers

The price of organic heifers remains at $2,000 ...... 25 percent of heifers are transitioning ...... $488,000 $0 The price of organic heifers remains at $2,000 ...... 50 percent of heifers are transitioning ...... 975,000 0 The price of organic heifers rises from $2,000 to 25 percent of heifers are transitioning ...... 732,000 731,000 $2,500. The price of organic heifers rises from $2,000 to 50 percent of heifers are transitioning ...... 1,462,500 487,500 $2,500.

If some of the sellers of the 975 proposed rule. Ten percent of of operations with between 100 and 199 additional organic heifers required operations with fewer than 50 cows cows reported purchasing heifers, and under the 50 percent assumption (or the reported purchasing milk cows, and the the average number purchased was 17 488 additional organic heifers required average number purchased was 6 head. head. Seven (7) percent of operations under the 25 percent assumption) have Five percent of operations with between with 200 or more cows reported costs to supplying these animals that are 50 and 99 cows reported purchasing purchasing heifers, and the average less than $2,500, then industry transfers milk cows, and the average number number purchased was 12 head. Based would exceed the values stated in Table purchased was 14 head. Three percent on a cost differences of $1,500 per head 4. Increased sales are expected to benefit of operations with between 100 and 199 between transitioned replacement operations that have more flexibility in cows reported purchasing milk cows, heifers and organic replacement heifers, capacity (e.g., available pasture) to and the average number purchased was and assuming that half of replacement accommodate raising organic 10 head. No operations with 200 or heifers currently purchased are replacement heifers for the organic more cows reported purchasing milk transitioned, the average dairy with market. Importantly, sales response cows. fewer than 50 cows would pay an across individual farms will likely be The pattern is different for purchasing additional $382–$510; dairies with uneven and depend on site-specific heifers. Eight percent of operations with between 50 and 99 cows would pay an factors such as the farm’s ability to fewer than 50 cows reported purchasing additional $499–$666; dairies with access new buyers and increase organic heifers, and the average number between 100 and 199 cows would pay pasture. purchased was 7 head. Sixteen (16) an additional $1,316–$1,755; and Differences in purchase patterns of percent of operations with between 50 dairies with 200 or more cows would milk cows and replacement heifers also and 99 cows reported purchasing pay an additional $628–$837. The costs vary by size in a way that affects the heifers, and the average number by size of operation are summarized in distribution of costs associated with the purchased was 4 head. Ten (10) percent Table 5. TABLE 5—COSTS BY SIZE OF OPERATION FOR PURCHASING ORGANIC HEIFERS

Size of operation Fewer than 50 cows 50–99 Cows 100–199 Cows 200 Or more cows

Share of Operations ...... 43% 34% 13% 10% Percent of operations that purchased replacement heifers ...... 8% 16% 10% 7% Average number of replacement heifers purchased ...... 6.68 4.06 17.22 12.33 Number of Farms ...... 1,114 879 324 247 Average Cost Per Farm ...... $382–$510 $499–$666 $1,316–$1,755 $628–$837 Total cost for purchase of replacement heifers across size class ...... $425,849–$567,798 $438,939–$585,252 $426,377–$568,502 $155,007–$206,676 Cost per operation for operations purchasing replacements ...... $5,009–$6,678 $3,048–$4,063 $12,919–$17,225 $9,247–$12,330

The costs in Table 5 do not reflect the (net of transfer) and transfers in Table 4 Effects on Heifer-Raising Operations offsetting effect of transfers. For this ($2.44 million and $2.92 million) with reason, the sum of the total costs of minor discrepancies reflecting rounding Organic dairy operations that replacing heifers across all size differences. continually source transitioned heifers categories ($2.41 million and $2.89 would need to change their practices to million) roughly equals the sum costs meet the requirements of the proposed

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rule. In some cases, organic dairy Within our analysis, we have assumed approached the hard limit for dairy operations source their transitioned that competitive markets for both cattle growth. heifers from off-site heifer-raising transitioning and replacement heifers For additional discussion, see our operations. Here, we discuss the have resulted in prices for these animals response to comments on ‘‘Effect on potential effects of the proposed rule on that are sufficiently high enough to consumer milk price’’ above. these operations. allow sellers to recover the cost of Benefits of the Proposed Rule A 2011 USDA NAHMS study on raising these animals along with a heifer-raising operations 32 found that ‘‘normal’’ rate of return on capital The proposed rule would provide most heifers sent to heifer-raising investment. The analysis assumes that producers and consumers of organic operations (80 percent) are returned to the 50 percent conjectured increase in foods with multiple types of benefits. their dairy of origin. The study also price of organic replacement heifers is First, the rule would give specificity and found that most heifer-raising sufficient to simultaneously ensure that clarity to the enforcement of regulations operations receive weaned calves (rather markets clear (i.e. quantity supplied relating to the origin of dairy livestock than wet calves) and send them back as equals quantity demanded) at the higher and the management of breeder stock, pregnant heifers. In the 2015 proposed number of transacted animals and offset Second, the rule would create rule, AMS specifically requested the increased costs to supplying more uniformity in the application of the comments and data on the likely animals. USDA organic regulations by generally requiring organic management for an impacts on heifer-raising operations. We As with other aspects of our analysis did not receive any data on the number animal’s entire life. Together, these may regarding supply response, AMS enhance the value of organic premiums of heifer-raising operations that assumes that the ability of individual continually transition animals for sale to that consumers are willing to pay for sellers of replacement heifers to adjust milk certified under the USDA organic organic dairies or on the number of management practices to market animals raised by such operations regulations by reducing uncertainty. conditions will vary with the site- The 2016 NASS Certified Organic annually. Aside from fragmentary specific characteristics of operations, evidence in the AMS Organic Integrity Production Survey show that U.S. farms such as their ability to find new buyers Database, AMS does not currently have and ranches produced and sold $7.6 and access to additional organic pasture. specific data on the locations, numbers, billion in certified organic commodities, Whether heifer-raising operations will or sizes of organic heifer-raising up 23 percent from 2015. At the retail increase or decrease sales of organic operations.33 level, the OTA 2019 U.S. Industry In the absence of specific information, heifers following the implementation of Survey found that retail sales of organic we considered that organic dairy the rule cannot be determined with the production totaled $52.5 billion, 6 operations could be using organic available data. percent above the previous year. heifer-raising operations to transition Effects on Consumers Organic dairy cattle producers who sell animals on a continual basis by taking organic dairy females may receive a in nonorganic weaned calves (e.g., 12- Most dairies report that they source at benefit as part of an intra-industry month old heifers) and providing least some of their replacement cows transfer. AMS estimates that on the high organic management for 12 months from their own calves, and only 11 side, the price of an organic springer before returning the pregnant organic percent of all dairies purchase may increase by $500 over current heifers to an organic dairy. replacement heifers, with less than 1 prices due to increased demand. If this Under the proposed rule, heifer- percent of all replacements being price increase were to occur, dairy raising operations would not be purchased from off the farm. The producers who are net sellers of required to change their animal majority of producers that do not replacement springers would benefit production practices. These operations purchase replacement heifers would not through the intra-industry transfer. are certified organic and currently see an increase in costs. To replace AMS does not expect the proposed manage animals in compliance with the purchased transitioned heifers, dairies rule to increase demand for organic USDA organic regulations as a would have to either raise their own milk. However, AMS does expect the requirement of their organic replacements or buy them from an proposed rule to help support consumer certification. However, the proposed operation that sells organic (from last confidence by preventing organic rule would not allow any operations, third of gestation) replacement heifers. dairies from continuing to transition once certified, to continually source Since the current supply of replacement non-organic animals into organic milk nonorganic animals. Therefore, these heifers can be increased without large production. The sustained demand operations would be able to accept only price increases, as detailed above, it is should be valuable for organic milk weaned calves that had been managed unlikely that the proposed rule would producers and strengthen the value of organically from the last third of significantly increase milk production the organic brand in the mind of gestation. or milk costs to the consumer. Some consumers; these outcomes are not commenters to the 2015 proposed rule benefits in themselves, as that term is 32 USDA, Animal Plant Health Inspection Service. suggested that the limits on transitions defined for purposes of Executive Order Dairy Heifer Raiser, 2011 (October 2012). Available would increase the price of organic milk online at: https://www.aphis.usda.gov/aphis/ 12866 and OMB Circular A–4, but to the ourfocus/animalhealth/monitoring-and- for consumers. They noted that with the extent that they disincentivize the surveillance/nahms/nahms_dairy_studies. proposed limits on transitions, organic (costly) establishment of credentials that 33 The Organic Integrity Database includes growth for existing organic dairy farms are alternative to USDA organic descriptions of the products for which organic would be biologically capped at 5 certification, the associated cost savings farms are certified as recorded by the certifying percent. Any additional growth would agent. It lists 220 operations that recorded dairy qualify as rule-induced benefits. cattle but not milk production (i.e., a possible need to come from new organic dairy indicator for a heifer-raising operation). These farms or nonorganic dairy farms Alternatives Considered operations were often identified as being involved transitioning to organic milk As required by Executive Order with ‘‘dairy cows,’’ ‘‘breeding operations,’’ and 12866, AMS considered alternative ‘‘replacements.’’ Unfortunately, the database does production. These commenters stated not provide sufficient information to use in our that the price of organic milk for regulatory approaches in our analysis of heifer-raising operations. consumers could rise if demand development and analysis of the

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proposal. AMS considered alternatives The alternatives considered are shown that would be both less stringent (less in Table 6 and discussed below. costly) and more stringent (more costly).

TABLE 6—ALTERNATIVES CONSIDERED

Alternative Description

(A) Allow Continual Transition ...... Allow any operation to transition nonorganic dairy animals into organic production over a 12-month pe- riod on a continual basis. (B) Prohibit All Transitions ...... Remove all exceptions for transition of nonorganic animals.

Alternative A—Allow Continual transitioned. AMS assumes that the consistent and uniform standard for all Transition price difference between organic (last operations. The National Organic AMS considered amending the third of gestation) and transitioned Standards Board’s recommendations regulations to specify that any operation heifers accurately reflects the cost and stakeholder comments support could transition dairy animals into difference of $1,000 in raising heifers for AMS’ decision to not select this organic production over a 12-month milking under those two comparative alternative, as comments indicate that at period on a continual basis. Under production systems. In this case, the least some consumers expect organic OFPA, a dairy animal from which milk benefit of allowing for continuous milk be produced without the use of or milk products will be sold or labeled transitioning of heifers is $9,711,000. antibiotics (and other substances as organically produced must be raised While the cost difference might prohibited under the USDA organic in accordance with OFPA for not less suggest that organic farms would regulations) and expect organic than the 12-month period immediately acquire an even larger share of heifer management of all animals on organic prior to the sale of such milk and milk replacements through purchases rather operations. than internally through breeding, AMS products (7 U.S.C. 6509(e)(2)(A)). Alternative B—Prohibit All Transitions AMS could presumably allow feels this is unlikely owing to the transition of any dairy animal into asymmetric information problems A second alternative AMS considered organic production, without further associated with cattle sales. Asymmetric was to remove any allowance for dairy limitation, if the animal were managed information problems arise because operations to transition animals to organically for the 12-month period heifer sellers have more information organic production, including new and prior to the sale of milk as organic. In than heifer buyers about the health, nonorganic dairies seeking to convert to effect, this would mean that an breeding, and temperament of their organic production. Under this option, operation could continually transition animals. This has the effect of reducing all dairy animals would need to be nonorganic dairy animals into organic total transactions in the market (Akerlof, managed organically from the last third 34 35 production on an ongoing basis, as 1970). of gestation for milk and dairy products opposed to allowing an operation to The potential cost associated with the to be sold, labeled, or represented as transition animals into organic adoption of the continuous transition organic. production once. In this scenario, for all organic dairies could be The costs of this alternative are organic dairy farms using heifer-raising illustrated by a deleterious effect on threefold. First, producers would bear operations following organic practices markups to products marketed under the increased annual costs of $1,462,500 would now use heifer-raising operations the organic label; although a markup described in Table 4 and under the one- that treat the young animals with reduction is not a cost, from the society- time transition scenario where 50 antibiotics and other medications wide perspective taken for purposes of percent of heifers are transitioning. prohibited in organic livestock Executive Order 12866 and OMB Because conventional organic dairy production and/or provide nonorganic Circular A–4, it may be a sign of an farms transitioning to organic would feed until one year before they were increased incentivize for the (costly) also need to purchase heifers and expected to produce milk. Also, in the establishment of credentials that are milking cows approximately equal to scenario, all purchased replacements alternative to USDA organic the size of their current operations, would be transitioned heifers. Relatedly, certification. Table 1 shows that milk AMS believes that the price increase for operations wanting to assure consumers products marketed under the organic organic heifers may significantly exceed that they had raised organic heifers label earned an average markup of 47 a 50 percent price increase. under organic conditions through their percent over conventional products that Second, this alternative would limit entire lives would have to do so under total $1.8 billion in total value. A one the ability of the industry to expand to a separate certification program. percent fall in total markups would be meet growing demand and thereby ARMS Data indicated that the average associated with a $18 million reduction create price instability within the organic dairy operation kept 40.4 heifers in organic premiums at the retail level. market. In periods of stable demand, (or 39.3 percent of its herd) for breeding Continual transition could achieve the firm entry into the organic market is and 36.6 heifers (or 35.7 percent of its regulatory objective of establishing a modest, reflecting factors such as herd) were kept for breeding and raised population and income growth. In these on the operation. The difference of these 34 George, Akerlof. (1970) The Market for Lemons: stable periods under current rules, the Quality Uncertainty and the Market Mechanism. In: values, 3.6 percent, represents the likely The Quarterly Journal of Economics. cost of producing organic milk for proportion of organic heifers raised on 35 Such information asymmetries create a established producers reflects both the outside heifer-raising operations (as a ‘‘lemons problem’’ where buyers assume that only higher cost of production in terms of share of the total herd). If all those the lowest quality heifers would be sold by dairy feed costs, land requirements, and farms while the best are retained for internal on animals become transitioned heifers, farm use. Dairies, in turn, sell only their lower animal husbandry practices, and the then an additional 9,711 animals (i.e., quality heifers because the sales price is too low to higher cost of replacement heifers. In 267,523 head * 3.6 percent) would be justify bringing higher quality animals to market. periods of industry growth (i.e., high

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demand), entrants to this industry bear exceptions, to all organic dairy businesses subject to the action. those costs as well, but also face the operations. It would also align the Pursuant to the requirements set forth in significant additional costs of requirements for dairy animals with the RFA, AMS performed an economic converting land for organic feed and requirements for organic slaughter impact analysis on small entities. Small pasture over a 3-year period. Under this stock. AMS does not believe this option entities include producers and alternative, in periods of industry is necessary for several reasons. agricultural service firms, such as growth (i.e., high demand) new entrants First, AMS believes that certifiers will handlers and accredited certifying to the industry would face the be able to enforce a rule that allows for agents. AMS has determined that the additional cost of acquiring organic a limited and well-defined transition. proposed action would impact small heifers and milking cows under periods Second, AMS believes that allowing entities but that it would not have a of tight supply and this alternative one-time transitions for organic dairy significant economic impact on them. could lengthen the time required for operations maintains market stability RFA permits agencies to prepare the new entrants to begin production. While while simultaneously preserving the regulatory flexibility analysis in a subset of organic dairies would see value of the organic label. Third, AMS conjunction with other analyses higher returns on sales of heifers, notes that other aspects of the USDA required by law, such as RIA. AMS incumbent farms seeking to grow would organic regulations slow entry into this notes that several requirements of the see higher costs of expanding herds market and believes that eliminating its regulatory flexibility analysis overlap through heifer purchases and the historic allowance of dairy animal with those of RIA. For example, RFA additional time required to certify transitions would unfairly burden requires a description of the reasons additional land under the organic downstream organic processors and why the action by the agency is being program. While some incumbent retailers who have invested in the considered and an analysis of the producers may benefit under this industry based on the expectation of the proposed rule’s costs to small entities. alternative in the short-term, the added continuation of regulations that ensure RIA likewise describes the need for the costs to entry and expansion would a stable and responsive market supply. proposed rule, the alternatives likely foster price volatility for organic Most comments objected to the presence considered, and the potential costs and heifers and wholesale organic milk, as of different requirements across the benefits of the proposed rule. In order the supply has a limited ability to industry, depending on how a certifying to avoid duplication, we combine some expand in response to demand agent interprets the regulations. Most analyses as allowed in § 605(b) of RFA. fluctuations. commenters supported a one-time As explained below, AMS expects that Organic heifers are an input to allowance. the entities that could be impacted by the proposed rule would qualify as wholesale organic milk production, and Conclusions wholesale milk is an input to retail small businesses. In RIA, the discussion organic milk products such as organic AMS is proposing a regulatory option of alternatives and the potential costs cheese, yogurt, butter, and retail-level that retains the opportunity for new and benefits pertains to impacts upon milk. Bringing organic milk products to operations to transition into organic all entities, including small entities. market requires complementary dairy production once. We are Therefore, the scope of those investments in retail marketing outlets reopening the comment period to solicit discussions in RIA is applicable to and brand development. Bernanke views on whether the final rule should regulatory flexibility analysis under (1983), Cabellero and Pindyck (1996), prohibit certified organic dairy RFA. RIA should be referred to for more and Carruth et al. (2000) find that operations from acquiring transitioned detail. animals to expand or replace animals to increasing input price volatility reduces Potentially Affected Small Entities investment since the value of the option produce organic milk. We are also seeking comment on whether AMS AMS has considered the economic to delay the investment rises with impact of the proposed action on small increased uncertainty about the should use the term ‘‘operation’’ to 36 37 38 describe the regulated entity, rather than entities. Small entities include investment’s return. Such producers transitioning into organic volatility could limit long-term growth ‘‘producer.’’ A clear and consistent standard for dairy production, existing organic dairy in organic milk demand if downstream transition of dairy animals into organic producers, producers that raise milk processors (for cheese and other production is needed and anticipated by replacement animals for organic dairies, milk products) and retailers require an dairy producers, consumers, trade and certifying agents. AMS believes that organic milk supply with stable prices associations, certifying agents, and the cost of implementing the proposed to allow for planning of other USDA’s OIG. AMS seeks to provide a rule will fall primarily on organic investments such as equipment, brand foundation for compliance and dairies that currently purchase promotion, and retail promotion, which enforcement in support of fair transitioned heifers, although any in some cases constitutes building retail competition among dairy operations organic dairies that purchase organic stores focused solely on the sale of through a well-defined and consistently heifers would be expected to pay higher organic products. implemented standard. prices in the short-term due to increased This alternative would simplify competition for these animals. Farms enforcement of the requirements by Regulatory Flexibility Analysis that sell their excess organic applying a single standard, without The Regulatory Flexibility Act (RFA) replacement heifers may see an increase (5 U.S.C. 601–612) requires agencies to in demand for their heifers, and farms 36 Bernanke, Ben S. (1983) ‘‘Irreversibility, Uncertainty and Cyclical Investment’’, Quarterly consider the economic impact of each that raise their own organic replacement Journal of Economics (98) 85–106. rule on small entities and evaluate heifers would not likely be affected by 37 Caballero, Ricardo J. and Pindyck, Robert S. alternatives that would accomplish the the proposal. AMS believes heifer ‘‘Uncertainty, Investment, and Industry Evolution’’ objectives of the rule without unduly development operations also could be International Economic Review (1996)37:641–663. burdening small entities or erecting impacted by this action. However, 38 Carruth, A., Dickerson, A., and Henley, A. (2000) ‘‘What do We Know About Investment barriers that would restrict their ability limited information on the number and Under Uncertainty?’’ Journal of Economic Surveys to compete in the market. The purpose size of heifer development operations (14)2: 119–154. is to fit regulatory actions to the scale of prevents our estimation of the number

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of such entities and any increased costs by SBA (13 CFR 121.201), small 6.8 percent of large farms that purchase for those entities. agricultural producers are those having replacement heifers buying 12.3 head on The Small Business Administration annual receipts of less than $1,000,000. average. (SBA) defines small agricultural service AMS used this SBA criterion to identify For this cost analysis, we assumed firms, which include certifying agents, large organic dairy operations, those that the difference in cost between as those having annual receipts of less with cash receipts of more than transitioned replacement heifers and than $8,000,000 (13 CFR 121.201). $1,000,000, and small operations, those There are currently 78 USDA-accredited with cash receipts of $1,000,000 or less. organic (from last third of gestation) certifying agents; based on a query of Data on the exact shares of organic replacement heifers is currently $1,000 NOP certified organic operations dairy farms that have sales above and per head, that half of organic database, there are approximately 47 below $1,000,000 are not available. replacement heifers currently purchased certifying agents who are currently However, ARMS data indicates that the are transitioned, and that the increased involved in the certification of organic average sales revenue of dairy farms demand for organic replacement heifers dairies. Of those 47 certifiers, 14 are from sales of organic milk and animals raises their price by $500. Based on our State governments, 2 are county is $2,855 per milked cow, a figure that analysis, AMS estimates that, under the governments, and 1 is a large State indicates that revenues exceed proposed rule, small operations would university. AMS believes that none of $1,000,000 for farms with more than 350 collectively spend an additional these 17 public entities would meet head. $1,312,317 to $1,749,756 for heifers. SBA criterion for small agricultural Within the 2016 ARMS data, 90 Large operations would collectively pay service firms, but that the 29 other percent of dairy farms (300 of the 332) an additional $128,649 to $171,532 for private certifying agents would. While had fewer than 200 milking animals. heifers. Of the operations that purchase certifying agents are small entities that Lacking more detailed information, we heifers, the average additional cost per assume that 92 percent of all organic would be affected by the proposed rule, operation in the 50 percent price we do not expect that these certifying dairy farms (or 2,354 of 2,559) qualify as increase scenario would be $4,926 to agents would incur significant costs as small businesses under the SBA standard. We also assume that these $6,569 for small operations and $9,247 a result of this action. Certifying agents 39 already must comply with the current farms purchase replacement heifers in to $12,330 for large operations. AMS regulations, e.g., maintaining the same pattern as the average farm notes that this analysis assumed that certification records for organic dairy with 200 or fewer head. In this case, there is no difference in the cost per operations. small organic dairy farms purchase 0.7 head paid by large and small operations For the regulatory flexibility analysis, replacement heifers on average, with the for purchases of replacement heifers and AMS focused on estimating how 11.3 percent of small farms that that these costs estimates do not include different size organic dairy operations purchase replacement heifers buying 6.6 transfers.40 Table 7 summarizes the cost (small versus large) would be impacted head on average. In contrast, large analysis using SBA criterion for small as a result of purchasing all organic organic dairy farms purchase 0.8 businesses (i.e., producers with less dairy replacement animals. As defined replacement heifers on average, with the than $1,000,000 in cash receipts).

TABLE 7—COST OF ORGANIC REPLACEMENT HEIFERS BY SBA CRITERION FOR SMALL BUSINESSES

Small operations Large operations (<$1,000,000) (> = $1,000,000)

Total cost (all operations) ...... $1,312,317–$1,749,756 $128,649–$171,532 Per operation purchasing replacement heifers (25% to 50% transitioned replacements) $4,926–$6,569 $9,247–$12,330

To understand the potential costs in heifers will see costs increase by 0.7 rule due to the need for greater context, we used the higher average cost percent. consistency in applying the origin of estimate per operation from Table 7 for It is important to note that these cost livestock standard across the organic the purchase of organic replacement figures do not include the potential dairy sector. heifers (i.e., $6,569 for small; $12,330 offsetting effect of transfers, or increased AMS has not identified any relevant for large) and compared it to the average revenue from replacement heifer sales Federal rules that are currently in effect gross cash farm income for farms with as organic replacement heifer prices that duplicate, overlap, or conflict with 200 head or fewer and for farms with increase. This revenue is recorded as a the proposed rule. The proposed action more than 200 head using a revenue transfer in the benefit-cost analysis. would provide additional clarity on the estimate from ARMS data that farms If implemented, the proposed rule origin of livestock requirements that are earn $2,855 per head. Of farms with 200 would, as discussed in the benefits specific and limited to the USDA head or fewer and $158,003 in sales on portion of RIA, ensure that consumer organic regulations. average, the 11.3 percent of farms expectations are met and support the purchasing replacement heifers will market for these organic products. AMS Erin Morris, have their costs increase 4.2 percent on believes that the long-term economic Associate Administrator, Agricultural average. Of large farms with more than impact on producers of not Marketing Service. 200 head and $1,683,366 in revenue, the implementing the proposal would be [FR Doc. 2021–09978 Filed 5–11–21; 8:45 am] 12.33 percent purchasing replacement greater than the economic impact of a BILLING CODE P

39 Small operations making purchases buy 6.57 pay $1,000 more for half those animals and $2,000 transitioning scenarios) roughly equal the Table 4 heifers and will pay $1,000 more for half those on the others. estimates of costs net of transfers ($1.463 million animals and $2,000 on the others. Large operations 40 As with the Table 5 costs breakout by operation and $1.950 million). Discrepancies are attributed to making purchases buy 12.33 heifers and will also size, total costs in Table 7 ($1.440 million and rounding errors. $1.921 million under the 25 and 50 percent

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DEPARTMENT OF AGRICULTURE SUPPLEMENTARY INFORMATION: This of salable dried prunes for the 2020–21 action, pursuant to 5 U.S.C. 553, and subsequent crop years. Agricultural Marketing Service proposes to amend regulations issued to The Order authorizes the Committee, carry out a marketing order as defined with the approval of USDA, to formulate 7 CFR Part 993 in 7 CFR 900.2(j). This proposed rule is an annual budget of expenses and [Doc. No. AMS–SC–20–0104; SC21–993–1 issued under Marketing Agreement and collect assessments from handlers to PR] Order No. 993, as amended (7 CFR part administer the program. The members 993), regulating the handling of dried are familiar with the Committee’s needs Dried Prunes Produced in California; prunes produced in California. Part 993 and with the costs of goods and services Increased Assessment Rate (referred to as the ‘‘Order’’) is effective in their local area and are in a position under the Agricultural Marketing to formulate an appropriate budget and AGENCY: Agricultural Marketing Service, Agreement Act of 1937, as amended (7 assessment rate. The assessment rate is USDA. U.S.C. 601–674), hereinafter referred to formulated and discussed in a public ACTION: Proposed rule. as the ‘‘Act.’’ The Committee locally meeting. Thus, all directly affected persons have an opportunity to SUMMARY: This proposed rule would administers the Order and is comprised implement a recommendation from the of producers and handlers of dried participate and provide input. For the 2019–20 and subsequent crop Prune Marketing Committee prunes operating within the production years, the Committee recommended, (Committee) to increase the assessment area, and a public member. and USDA approved, an assessment rate rate established for the 2020–21 and The Department of Agriculture of $0.25 per ton of salable dried prunes. subsequent crop years. The proposed (USDA) is issuing this proposed rule in That assessment rate continues in effect assessment rate would remain in effect conformance with Executive Orders from crop year to crop year unless indefinitely unless modified, 13563 and 13175. In accordance with modified, suspended, or terminated by suspended, or terminated. Executive Order 13175, AMS has not identified any tribal implications as a USDA upon recommendation and DATES: Comments must be received by result of this proposed rule. This information submitted by the June 11, 2021. proposed rule falls within a category of Committee or other information ADDRESSES: Interested persons are regulatory actions that the Office of available to USDA. invited to submit written comments Management and Budget (OMB) The Committee met on December 10, concerning this proposed rule. exempted from Executive Order 12866 2020, and unanimously recommended Comments must be sent to the Docket review. expenditures of $24,550 and an Clerk, Marketing Order and Agreement This proposed rule has been reviewed assessment rate of $0.28 per ton of Division, Specialty Crops Program, under Executive Order 12988, Civil salable dried prunes handled for the AMS, USDA, 1400 Independence Justice Reform. Under the Order now in 2020–21 and subsequent crop years. In Avenue SW, STOP 0237, Washington, effect, California dried prune handlers comparison, last year’s budgeted DC 20250–0237; or internet: https:// are subject to assessments. Funds to expenditures were $24,500. The www.regulations.gov. Comments should administer the Order are derived from proposed assessment rate of $0.28 is reference the document number and the such assessments. It is intended that the $0.03 higher than the rate currently in date and page number of this issue of assessment rate would be applicable to effect. The Committee recommended the Federal Register and will be all assessable dried prunes for the 2020– increasing the assessment rate due to a available for public inspection in the 21 crop year and continue until smaller crop, and to provide adequate Office of the Docket Clerk during regular amended, suspended, or terminated. income along with carryforward/ business hours, or can be viewed at: The Act provides that administrative contingency funds and interest income https://www.regulations.gov. All proceedings must be exhausted before to cover all of the Committee’s budgeted comments submitted in response to this parties may file suit in court. Under expenses for the 2020–21 crop year. rule will be included in the record and section 608c(15)(A) of the Act, any The major expenditures will be made available to the public. handler subject to an order may file recommended by the Committee for the Please be advised that the identity of the with USDA a petition stating that the 2020–21 crop year include $13,700 for individuals or entities submitting the order, any provision of the order, or any personnel expenses, and $10,850 for comments will be made public on the obligation imposed in connection with operating expenses. Budgeted expenses internet at the address provided above. the order is not in accordance with law for these items for the 2019–20 crop FOR FURTHER INFORMATION CONTACT: and request a modification of the order year were $13,300 for personnel Bianca Bertrand, Management and or to be exempted therefrom. Such expenses, and $11,200 for operating Program Analyst, or Andrew Hatch, handler is afforded the opportunity for expenses. Acting Director, Marketing Order and a hearing on the petition. After the The Committee derived the Agreement Division, Specialty Crops hearing, USDA would rule on the recommended assessment rate by Program, AMS, USDA; Telephone: petition. The Act provides that the considering anticipated expenses, and (559)356–8202 or email: district court of the United States in any an estimated crop of 50,000 tons of [email protected] or district in which the handler is an salable dried prunes. Income derived [email protected]. inhabitant, or has his or her principal from handler assessments, calculated at Small businesses may request place of business, has jurisdiction to $14,000 (50,000 tons salable dried information on complying with this review USDA’s ruling on the petition, prunes multiplied by $0.28 assessment regulation by contacting Richard Lower, provided an action is filed no later than rate), along with carryforward/ Marketing Order and Agreement 20 days after the date of the entry of the contingency funds and interest income Division, Specialty Crops Program, ruling. ($11,682), would be adequate to cover AMS, USDA, 1400 Independence This proposed rule would increase budgeted expenses of $24,550. Avenue SW, STOP 0237, Washington, the assessment rate from $0.25 per ton The assessment rate proposed in this DC 20250–0237; Telephone: (202) 720– of salable dried prunes, the rate that was rule would continue in effect 2491, Fax: (202) 720–8938, or email: established for the 2019–20 and indefinitely unless modified, [email protected]. subsequent crop years, to $0.28 per ton suspended, or terminated by USDA

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upon recommendation and information per ton equals $166,100,000). Dividing operating expenses. Budgeted expenses submitted by the Committee or other the crop value by the estimated number for these items in the 2019–20 crop year available information. of producers (800) yields an estimated were $13,300, and $11,200 respectively. Although this assessment rate would average receipt per producer of The Committee recommended be in effect for an indefinite period, the $207,625. increasing the assessment rate due to a Committee will continue to meet prior According to USDA Market News smaller crop, and to provide adequate to or during each crop year to data, the reported terminal price for income along with carryforward/ recommend a budget of expenses and 2019 for California dried prunes ranged contingency funds and interest income consider recommendations for between $30.02 to $32.59 per 28-pound to cover the Committee’s budgeted modification of the assessment rate. The carton. The average of this range is expenses for the 2020–21 crop year. dates and times of Committee meetings $31.31 ($30.02 plus $32.59 divided by 2 Prior to arriving at this budget and are available from the Committee or equals $31.31). Dividing the average assessment rate recommendation, the USDA. Committee meetings are open to value by the 28-pound carton yields an Committee discussed various the public and interested persons may estimated average price per pound of alternatives, including maintaining the express their views at these meetings. $1.12 ($31.31 average value for 28- current assessment rate of $0.25 per ton USDA would evaluate Committee pound carton divided by 28). The of salable dried prunes, and increasing recommendations and other available handler price for prunes is $2,240 per the assessment rate by a different information to determine whether ton ($1.12 per pound multiplied by amount. However, the Committee modification of the assessment rate is 2000 pounds per ton equals $2,240 per determined that the recommended needed. Further rulemaking would be ton). Multiplying the 2019–20 California assessment rate, along with undertaken as necessary. The dried prune total production of 110,000 carryforward/contingency funds and Committee’s 2020–21 crop year budget, tons by the estimated average price per interest income would fund budgeted and those for subsequent crop years, ton of $2,240 equals $246,400,000. expenses. would be reviewed and, as appropriate, Dividing this figure by 20 regulated This proposed rule would increase handlers yields estimated average approved by USDA. the assessment obligation imposed on annual handler receipts of $12,320,000. handlers. Assessments are applied Initial Regulatory Flexibility Analysis Therefore, using the above data, the uniformly on all handlers, and some of Pursuant to requirements set forth in majority of producers and handlers of the costs may be passed on to the Regulatory Flexibility Act (RFA) (5 California dried prunes may be producers. However, these costs would U.S.C. 601–612), the Agricultural classified as small entities. Marketing Service (AMS) has As noted above, the average price be offset by the benefits derived by the considered the economic impact of this received per ton by producers in the operation of the Order. proposed rule on small entities. preceding crop year was $1,510 per ton The Committee’s meeting was widely Accordingly, AMS has prepared this of salable dried prunes. Given the publicized throughout the California initial regulatory flexibility analysis. estimated tonnage of 50,000 tons salable prune industry. All interested persons The purpose of the RFA is to fit dried prunes for the 2020–21 crop year, were invited to attend the meeting and regulatory actions to the scale of the total producer revenue is estimated encouraged to participate in Committee businesses subject to such actions in to be $75,500,000. The total assessment deliberations on all issues. Like all order that small businesses will not be revenue is expected to be $14,000 Committee meetings, the December 10, unduly or disproportionately burdened. (50,000 tons multiplied by $0.28 per 2020, meeting was a public meeting, Marketing orders issued pursuant to the ton). Thus, the total assessment revenue and all entities, both large and small, Act, and the rules issued thereunder, are compared to total producer revenue is were able to express views on this issue. unique in that they are brought about 0.019 percent. Interested persons are invited to submit through group action of essentially This proposal would increase the comments on this proposed rule, small entities acting on their own assessment rate collected from handlers including the regulatory and behalf. for the 2020–21 and subsequent crop information collection impacts of this There are approximately 800 years from $0.25 to $0.28 per ton of action on small businesses. producers of dried prunes in the salable California dried prunes. The In accordance with the Paperwork production area and 20 handlers subject Committee unanimously recommended Reduction Act of 1995 (44 U.S.C. to the regulation under the Order. Small 2020–21 expenditures of $24,550 and an Chapter 35), the Order’s information agricultural producers are defined by assessment rate of $0.28 per ton of collection requirements have been the Small Business Administration salable dried prunes. The proposed previously approved by OMB and (SBA) as those having annual receipts of assessment rate of $0.28 per ton salable assigned OMB No. 0581–0178, less than $1,000,000, and small dried prunes is $0.03 higher than the Vegetable and Specialty Crops. No agricultural service firms have been current rate. The volume of assessable changes in those requirements would be defined as those whose annual receipts dried prunes for the 2020–21 crop year necessary as a result of this proposed are less than $30,000,000 (13 CFR is estimated to be 50,000 tons. Thus, the rule. Should any changes become 121.201). $0.28 per ton of salable dried prunes necessary, they would be submitted to According to the National should provide $14,000 in assessment OMB for approval. Agricultural Statistics Service (NASS), income (50,000 multiplied by $0.28). This proposed rule would not impose the national average producer price for Income derived from handler any additional reporting or California dried prunes for the 2019–20 assessments, along with carryforward/ recordkeeping requirements on either crop year was $1,510 per ton. contingency funds and interest income, small or large California prune handlers. Committee data indicates that the would be adequate to cover budgeted As with all Federal marketing order California dried prune total production expenses for the 2020–21 crop year. programs, reports and forms are was 110,000 tons in the 2019–20 crop The major expenditures periodically reviewed to reduce year. The total 2019–20 crop year value recommended by the Committee for the information requirements and of California dried prunes was 2020–21 crop year include $13,700 for duplication by industry and public $166,100,000 (110,000 tons times $1,510 personnel expenses, and $10,850 for sector agencies.

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AMS is committed to complying with NUCLEAR REGULATORY documents, is currently closed. You the E-Government Act, to promote the COMMISSION may submit your request to the PDR via use of the internet and other email at [email protected] or call information technologies to provide 10 CFR Part 50 1–800–397–4209 between 8:00 a.m. and increased opportunities for citizen [NRC–2018–0290] 4:00 p.m. (EST), Monday through access to Government information and Friday, except Federal holidays. RIN 3150–AK22 services, and for other purposes. FOR FURTHER INFORMATION CONTACT: USDA has not identified any relevant American Society of Mechanical Victoria V. Huckabay, Office of Nuclear Material Safety and Safeguards, Federal rules that duplicate, overlap, or Engineers 2019–2020 Code Editions; telephone: 301–415–5183, email: conflict with this proposed rule. Correction [email protected]; or Keith A small business guide on complying AGENCY: Nuclear Regulatory Hoffman, Office of Nuclear Reactor with fruit, vegetable, and specialty crop Commission. Regulation, telephone: 301–415–1294, marketing agreements and orders may ACTION: Proposed rule; correction. email: [email protected]. Both are be viewed at: https:// staff of the U.S. Nuclear Regulatory www.ams.usda.gov/rules-regulations/ SUMMARY: The U.S. Nuclear Regulatory Commission, Washington, DC 20555– moa/small-businesses. Any questions Commission (NRC) is correcting a notice 0001. that was published in the Federal about the compliance guide should be SUPPLEMENTARY INFORMATION: In the Register on March 26, 2021, regarding sent to Richard Lower at the previously Federal Register (FR) on March 26, its proposed amendment to the mentioned address in the FOR FURTHER 2021, at 86 FR 16087 in FR Doc. 2021– regulations to incorporate by reference INFORMATION CONTACT section. 06085, the following corrections are the 2019 Editions of the American A 30-day comment period is provided made: Society of Mechanical Engineers Boiler 1. On page 16094, in the second to allow interested persons to respond and Pressure Vessel Code and the 2020 to this proposed rule. All written column, under the heading Section Edition of the American Society of 50.55a(b)(2)(xxxii) Section XI Condition: comments timely received will be Mechanical Engineers Operation and considered before a final determination Summary Report Submittal, in the first Maintenance of Nuclear Power Plants, two sentences, the two occurrences of is made on this matter. Division 1: OM Code: Section IST, for the phrase ‘‘repair replacement List of Subjects in 7 CFR Part 993 nuclear power plants. This action is activities’’ are corrected to read ‘‘repair/ necessary to correct several replacement activities.’’ Marketing agreements, Plum, Prunes, typographical errors. 2. On page 16102, in the third Reporting and recordkeeping DATES: The correction takes effect on column, under the heading Overall requirements. May 12, 2021. Backfitting Considerations: Section XI of ADDRESSES: For the reasons set forth in the You may submit comments the ASME BPV Code and the ASME OM by any of the following methods (unless Code, in the first paragraph, the last preamble, 7 CFR part 993 is proposed to this document describes a different sentence is corrected to read ‘‘In this be amended as follows: method for submitting comments on a rulemaking, the NRC’s proposal to specific subject): eliminate some older Section XI PART 993—DRIED PRUNES • PRODUCED IN CALIFORNIA. Federal Rulemaking website: Go to editions and addenda from the https://www.regulations.gov and search regulations would not be a backfit for Docket ID NRC–2018–0290. Address because the editions and addenda of ■ 1. The authority citation for 7 CFR questions about NRC dockets to Dawn codes being removed are no longer in part 993 continues to read as follows: Forder; telephone: 301–415–3407; use or available for use by licensees.’’ Authority: 7 U.S.C. 601–674. email: [email protected]. For 3. On page 16103, in the second technical questions, contact the column, under the heading ASME BPV ■ 2. Section 993.347 is revised to read individuals listed in the FOR FURTHER Code, Section XI, item 1, the first as follows: INFORMATION CONTACT section of this sentence is corrected to read ‘‘Revise § 50.55a(a)(1)(ii) to remove the § 993.347 Assessment rate. document. • NRC’s Agencywide Documents incorporation by reference of the 1975 On and after August 1, 2020, an Access and Management System Winter Addenda, 1976 Summer assessment rate of $0.28 per ton of (ADAMS): You may obtain publicly- Addenda, 1976 Winter Addenda, and salable dried prunes is established for available documents online in the the Division 1 1977 Edition through California dried prunes. ADAMS Public Documents collection at 1994 Addenda and 1998 Edition https://www.nrc.gov/reading-rm/ through 2000 Addenda because they Erin Morris, adams.html. To begin the search, select incorporate by reference older editions Associate Administrator, Agricultural ‘‘ADAMS Public Documents’’ and then and addenda of Section XI that are no Marketing Service. select ‘‘Begin Web-based ADAMS longer in use or available for use by [FR Doc. 2021–10018 Filed 5–11–21; 8:45 am] Search.’’ For problems with ADAMS, licensees.’’ BILLING CODE 3410–02–P please contact the NRC’s Public 4. On page 16110, in the third Document Room (PDR) reference staff at column, in the middle of the column, 1–800–397–4209, 301–415–4737, or by paragraph (b)(2)(xviii)(D)(1), is corrected email to [email protected]. For the to read ‘‘(1) As an alternative to Note (c) convenience of the reader, instructions in Table VII–4110–1 of ASME BPV about obtaining materials referenced in Code, Section XI, 2010 Edition, the 250 this document are provided in the hours of Level I experience time may be ‘‘Availability of Documents’’ section. reduced to 175 hours, if the experience • Attention: The PDR, where you may time includes a minimum of 125 hours examine and order copies of public of field experience and 50 hours of

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laboratory practice beyond the OAR–2020–0412 at http:// of this rule and if that provision may be requirements for training in accordance www.regulations.gov or via email to severed from the remainder of the rule, with Appendix VII Subarticle 4220, [email protected]. For EPA may adopt as final those provisions provided those practice hours are comments submitted at Regulations.gov, of the rule that are not the subject of an dedicated to the Level I or Level II skill follow the online instructions for adverse comment. For additional areas as described in ANSI/ASNT CP– submitting comments. Once submitted, information, see the direct final rule 189.’’ comments cannot be edited or removed which is located in the Rules section of 5. On page 16111, in the second from Regulations.gov. For either manner this Federal Register. column, in the middle of the column, in of submission, EPA may publish any Dated: May 7, 2021. paragraph (b)(2)(xxv)(A), Mitigation of comment received to its public docket. Cheryl Newton, defects by modification: First person, Do not submit electronically any the paragraph heading is corrected to information you consider to be Acting Regional Administrator, Region 5. read ‘‘Mitigation of defects by Confidential Business Information (CBI) [FR Doc. 2021–10043 Filed 5–11–21; 8:45 am] modification: First provision’’. or other information whose disclosure is BILLING CODE 6560–50–P 6. On page 16112, in the second restricted by statute. Multimedia column, near the bottom of the column, submissions (audio, video, etc.) must be in paragraph (b)(2)(xliii), Section XI accompanied by a written comment. FEDERAL COMMUNICATIONS condition: Section XI Condition: The written comment is considered the COMMISSION Regulatory Submittal Requirements, the official comment and should include paragraph heading is corrected to read discussion of all points you wish to 47 CFR Part 73 ‘‘Section XI Condition: Regulatory make. EPA will generally not consider [MB Docket No. 21–177; RM–11904; DA 21– Submittal Requirements’’. comments or comment contents located 461; FR ID 26049] outside of the primary submission (i.e. Dated: May 5, 2021. Television Broadcasting Services For the Nuclear Regulatory Commission. on the web, cloud, or other file sharing system). For additional submission Redding, California Cindy K. Bladey, methods, please contact the person Chief, Regulatory Analysis and Rulemaking AGENCY: Federal Communications identified in the FOR FURTHER Support Branch, Division of Rulemaking, Commission. INFORMATION CONTACT section. For the Environmental, and Financial Support, Office ACTION: Proposed rule. of Nuclear Material Safety and Safeguards. full EPA public comment policy, [FR Doc. 2021–09997 Filed 5–11–21; 8:45 am] information about CBI or multimedia SUMMARY: The Commission has before it submissions, and general guidance on BILLING CODE 7590–01–P a petition for rulemaking filed by making effective comments, please visit Sinclair Media Licensee, LLC http://www2.epa.gov/dockets/ (Petitioner), the licensee of KRCR–TV commenting-epa-dockets. ENVIRONMENTAL PROTECTION (ABC), channel 7, Redding, California. AGENCY FOR FURTHER INFORMATION CONTACT: The Petitioner requests the substitution YeChan Lim, Environmental Engineer, of channel 15 for channel 7 at Redding, 40 CFR Part 52 Air Permits Section, Air Programs California in the DTV Table of Branch (AR–18J), Environmental Allotments. [EPA–R05–OAR–2020–0412; FRL–10023– Protection Agency, Region 5, 77 West 85–Region 5] DATES: Comments must be filed on or Jackson Boulevard, Chicago, Illinois before June 11, 2021 and reply 60604, (312) 886–7259, lim.yechan@ Air Plan Approval; Michigan; Part 18 comments on or before June 28, 2021. and Part 19 Revisions epa.gov. The EPA Region 5 office is open from 8:30 a.m. to 4:30 p.m., ADDRESSES: Federal Communications AGENCY: Environmental Protection Monday through Friday, excluding Commission, Office of the Secretary, 45 Agency (EPA). Federal holidays and facility closures L Street NE, Washington, DC 20554. In ACTION: Proposed rule. due to COVID–19. addition to filing comments with the SUPPLEMENTARY INFORMATION: In the FCC, interested parties should serve SUMMARY: The Environmental Protection Final Rules section of this Federal counsel for the Petitioner as follows: Agency (EPA) is proposing to approve Register, EPA is approving the State’s Paul A. Cicelski, Esq., Lerman Senter, Michigan Department of Environment, SIP submittal as a direct final rule PLLC, 2001 L Street NW, Washington, Great Lakes, and Energy (EGLE) without prior proposal because the DC 20036. promulgated revisions to its Part 18 Agency views this as a noncontroversial FOR FURTHER INFORMATION CONTACT: Prevention of Significant Deterioration submittal and anticipates no adverse Shaun Maher, Media Bureau, at (202) of Air Quality rule and the Part 19 New comments. A detailed rationale for the 418–2324; or Shaun Maher, Media Source Review for Major Sources approval is set forth in the direct final Bureau, at [email protected]. Impacting Nonattainment Areas rule. rule. If no relevant adverse comments SUPPLEMENTARY INFORMATION: In support The revisions made to Parts 18 and 19 are received in response to this rule, no of its channel substitution request, the were adopted to ensure consistency further activity is contemplated. If EPA Petitioner states that the Commission with Federal rule language and other receives such comments, the direct final has recognized that VHF channels have parts of the Michigan air quality rules. rule will be withdrawn, and all public certain propagation characteristics The proposed rule changes are comments received will be addressed in which may cause reception issues for administrative and are intended to a subsequent final rule based on this some viewers, and also that the provide clarity to the already approved proposed rule. EPA will not institute a reception of VHF signals requires larger rule language. second comment period. Any parties antennas, that are generally not well DATES: Comments must be received on interested in commenting on this action suited to the mobile applications or before June 11, 2021. should do so at this time. Please note expected under flexible use, relative to ADDRESSES: Submit your comments, that if EPA receives adverse comment UHF channels. According to the identified by Docket ID No. EPA–R05– on an amendment, paragraph, or section Petitioner, KRCR has received numerous

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complaints from viewers unable to Federal Communications Commission. L Street NE, Washington, DC 20554. In receive an over-the-air signal, despite Thomas Horan, addition to filing comments with the being able to receive signals from other Chief of Staff, Media Bureau. FCC, interested parties should serve counsel for the Petitioner as follows: stations. In addition, the Petitioner Proposed Rule submitted an analysis, using the Paul A. Cicelski, Esq., Lerman Senter, Commission’s TVStudy software For the reasons discussed in the PLLC, 2001 L Street NW, Washington, analysis program, demonstrating that preamble, the Federal Communications DC 20036. the proposed channel change from Commission proposes to amend 47 CFR FOR FURTHER INFORMATION CONTACT: channel 7 to 15 would result in a part 73 as follows: Andrew Manley, Media Bureau, at (202) 418–0596; or Andrew Manley, Media minimal loss of service to only 299 PART 73—RADIO BROADCAST Bureau, at Andrew [email protected]. people currently predicted to receive SERVICE KRCR’s signal. In addition, the SUPPLEMENTARY INFORMATION: In support Petitioner states that KRCR’s proposed ■ 1. The authority citation for part 73 of its channel substitution request, the channel 15 facility is predicted to serve continues to read as follows: Petitioner states that the reception of a total of 517,605 people, a net gain of Authority: 47 U.S.C. 154, 155, 301, 303, VHF signals require larger antennas 30,175 potential viewers over the 307, 309, 310, 334, 336, 339. relative to UHF channels, and that studies suggest a large variability in existing KRCR channel 7 licensed ■ 2. In § 73.622 in paragraph (i), amend facility. indoor antennas, with most receiving the Post-Transition Table of DTV fairly well at UHF and the substantial This is a synopsis of the Allotments under California by revising majority not so well to very poor for Commission’s Notice of Proposed the entry for Redding to read as follows: high-VHF channels. Petitioner further Rulemaking, MB Docket No. 21–177; § 73.622 Digital television table of states that KTVL has received numerous RM–11904; DA 21–461, adopted April allotments. complaints from viewers unable to 21, 2021, and released April 21, 2021. * * * * * receive that Station’s over-the-air signal, The full text of this document is (i) * * * despite being able to receive signals available for download at https:// from other stations. In its Amended www.fcc.gov/edocs. To request materials Community Channel No. Engineering Exhibit, the Petitioner in accessible formats (braille, large demonstrated that while the proposed print, computer diskettes, or audio channel 16 noise limited contour does recordings), please send an email to ***** not completely encompass the channel [email protected] or call the Consumer & California 10 noise limited contour, there are three Government Affairs Bureau at (202) other CBS affiliated stations that serve 418–0530 (VOICE), (202) 418–0432 all but 9,355 persons in the noise (TTY). ***** limited contour loss area. The Petitioner Redding ...... * 9, 15. also submitted an analysis, using the This document does not contain Commission’s TVStudy software information collection requirements ***** analysis program, demonstrating that subject to the Paperwork Reduction Act after taking into account service [FR Doc. 2021–10022 Filed 5–11–21; 8:45 am] of 1995, Public Law 104–13. In addition, provided by other CBS stations, all of therefore, it does not contain any BILLING CODE 6712–01–P the population located within KTVL’s proposed information collection burden channel 10 noise limited contour will ‘‘for small business concerns with fewer FEDERAL COMMUNICATIONS continue to receive CBS service, than 25 employees,’’ pursuant to the COMMISSION resulting in no loss of network service. Small Business Paperwork Relief Act of This is a synopsis of the 2002, Public Law 107–198, see 44 U.S.C. 47 CFR Part 73 Commission’s Notice of Proposed 3506(c)(4). Provisions of the Regulatory Rulemaking, MB Docket No. 21–155; Flexibility Act of 1980, 5 U.S.C. 601– [MB Docket No. 21–155; RM–11900; DA 21– RM–11900; DA 21–436, adopted April 436; FR ID 22597] 612, do not apply to this proceeding. 16, 2021, and released April 16, 2021. Members of the public should note Television Broadcasting Services The full text of this document is available for download at https:// that all ex parte contacts are prohibited Medford, Oregon www.fcc.gov/edocs. To request materials from the time a Notice of Proposed AGENCY: Federal Communications in accessible formats (braille, large Rulemaking is issued to the time the Commission. print, computer diskettes, or audio matter is no longer subject to ACTION: Proposed rule. recordings), please send an email to Commission consideration or court [email protected] or call the Consumer & review, see 47 CFR 1.1208. There are, SUMMARY: The Commission has before it Government Affairs Bureau at (202) however, exceptions to this prohibition, a petition for rulemaking filed by KTVL 418–0530 (VOICE), (202) 418–0432 which can be found in § 1.1204(a) of the Licensee, LLC (Petitioner), the licensee (TTY). Commission’s rules, 47 CFR 1.1204(a). of KTVL (CBS), channel 10, Medford, This document does not contain Oregon. The Petitioner requests the See §§ 1.415 and 1.420 of the information collection requirements substitution of channel 16 for channel Commission’s rules for information subject to the Paperwork Reduction Act 10 at Medford, Oregon in the DTV Table of 1995, Public Law 104–13. In addition, regarding the proper filing procedures of Allotments. for comments, 47 CFR 1.415 and 1.420. therefore, it does not contain any DATES: Comments must be filed on or proposed information collection burden List of Subjects in 47 CFR Part 73 before June 11, 2021 and reply ‘‘for small business concerns with fewer comments on or before June 28, 2021. than 25 employees,’’ pursuant to the Television. ADDRESSES: Federal Communications Small Business Paperwork Relief Act of Commission, Office of the Secretary, 45 2002, Public Law 107–198, see 44 U.S.C.

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3506(c)(4). Provisions of the Regulatory DEPARTMENT OF TRANSPORTATION FOR FURTHER INFORMATION CONTACT: Flexibility Act of 1980, 5 U.S.C. 601– Hunter B. Oliver, Office of Chief 612, do not apply to this proceeding. National Highway Traffic Safety Counsel, NHTSA, telephone (202) 366– Administration Members of the public should note 5263, facsimile (202) 366–3820, 1200 that all ex parte contacts are prohibited New Jersey Ave., SE. Washington, DC 49 CFR Parts 531 and 533 20590. from the time a Notice of Proposed Rulemaking is issued to the time the [Docket No. NHTSA–2021–0030] SUPPLEMENTARY INFORMATION: matter is no longer subject to Table of Contents Commission consideration or court RIN 2127–AM33 review, see 47 CFR 1.1208. There are, A. Public Participation Corporate Average Fuel Economy B. Executive Summary however, exceptions to this prohibition, (CAFE) Preemption C. Statutory and Regulatory Background which can be found in Section 1.1204(a) D. Reconsideration Authority of the Commission’s rules, 47 CFR AGENCY: National Highway Traffic E. Proposed Repeal of Regulations in the 1.1204(a). Safety Administration (NHTSA), SAFE I Rule Department of Transportation (DOT). See Sections 1.415 and 1.420 of the F. Proposed Repeal of Preemption ACTION: Notice of proposed rulemaking. Interpretations in the SAFE I Rule Commission’s rules for information G. Repealing the Regulations and Positions regarding the proper filing procedures SUMMARY: This document proposes to Announced in the SAFE I Rulemaking for comments, 47 CFR 1.415 and 1.420. repeal ‘‘The Safer Affordable Fuel- Remains Appropriate Even if NHTSA Efficient (SAFE) Vehicles Rule Part One: Possessed the Authority for the List of Subjects in 47 CFR Part 73 Rulemaking One National Program,’’ published Sept. H. Rulemaking Analyses and Notices Television. 27, 2019 (SAFE I Rule), in which 1. Executive Order 12866, Executive Order Federal Communications Commission. NHTSA codified regulatory text and 13563, and DOT Regulatory Policies and made additional pronouncements Procedures Thomas Horan regarding the preemption of state and 2. Regulatory Flexibility Act Chief of Staff, Media Bureau. local laws related to fuel economy 3. Executive Order 13132 (Federalism) Proposed Rule standards. Specifically, this document 4. Unfunded Mandates Reform Act of 1995 proposes to fully repeal the regulatory 5. National Environmental Policy Act For the reasons discussed in the text and appendices promulgated in the 6. Executive Order 12988 (Civil Justice Reform) preamble, the Federal Communications SAFE I Rule. In addition, this document 7. Paperwork Reduction Act Commission proposes to amend 47 CFR proposes to repeal and withdraw the 8. Privacy Act part 73 as follows: interpretative statements made by the Agency in the SAFE I Rule preamble, A. Public Participation PART 73—RADIO BROADCAST including those regarding the NHTSA requests comment on all SERVICE preemption of particular state aspects of this proposed rule. This Greenhouse Gas (GHG) Emissions section describes how you can ■ 1. The authority citation for part 73 standards or Zero Emissions Vehicle participate in this process. continues to read as follows: (ZEV) mandates. As such, this document proposes to establish a clean (1) How do I prepare and submit Authority: 47 U.S.C. 154, 155, 301, 303, slate with respect to NHTSA’s comments? 307, 309, 310, 334, 336, 339. regulations and interpretations Your comments must be written. To § 73.622 [Amended] concerning preemption under the ensure that your comments are correctly Energy Policy and Conservation Act filed in the docket, please include the ■ 2. In § 73.622 in paragraph (i), amend (EPCA). docket number NHTSA–2021–0030 in the Post-Transition Table of DTV DATES: your comments. If you are submitting Allotments under Oregon by revising Comments must be received by June 11, 2021. comments electronically as a PDF the entry for Medford to read as follows: (Adobe) file, we ask that the documents ADDRESSES: You may submit comments submitted be scanned using the Optical § 73.622 Digital television table of to the docket number identified in the Character Recognition (OCR) process, allotments. heading of this document by any of the thus allowing NHTSA to search and following methods: * * * * * copy certain portions of your • Federal eRulemaking Portal: Go to (i) * * * submissions.1 Please note that pursuant http://www.regulations.gov. Follow the to the Data Quality Act, in order for the online instructions for submitting Community Channel No. substantive data to be relied upon and comments. used by NHTSA, it must meet the • Mail: Docket Management Facility, information quality standards set forth M–30, U.S. Department of ***** in the Office of Management and Budget Transportation, West Building, Ground (OMB) and Department of Oregon Floor, Room W12–140, 1200 New Jersey Transportation (DOT) Data Quality Act Avenue SE, Washington, DC 20590. guidelines. Accordingly, we encourage • Hand Delivery or Courier: U.S. you to consult the guidelines in ***** Department of Transportation, West preparing your comments. OMB’s Medford ...... 5, * 8, 12, 16, 26 Building, Ground Floor, Room W12– guidelines may be accessed at https:// 140, 1200 New Jersey Avenue SE, www.whitehouse.gov/omb/information- ***** Washington, DC, between 9 a.m. and 5 p.m. Eastern time, Monday through [FR Doc. 2021–10062 Filed 5–11–21; 8:45 am] 1 OCR is the process of converting an image of Friday, except Federal holidays. text, such as a scanned paper document or BILLING CODE 6712–01–P • Fax: 202–493–2251. electronic fax file, into computer-editable text.

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regulatory-affairs/information-policy/. sent to an attorney in the Office of Chief emissions through GHG standards and a DOT’s guidelines may be accessed at Counsel at the address given above ZEV mandate.3 https://www.transportation.gov/dot- under FOR FURTHER INFORMATION The SAFE I Rule represented the first information-dissemination-quality- CONTACT. Likewise, for CBI submissions time, in the nearly 50-year history of the guidelines. via a secure file transfer application, an CAFE program, that NHTSA had attorney in the Office of Chief Counsel adopted regulations expressly defining (2) Tips for Preparing Your Comments must be set to receive a notification the Agency’s views on the scope of When submitting comments, please when files are submitted and have preemption of state laws that relate to remember to: access to retrieve the submitted files. At fuel economy. Until 2019, the self- • Identify the rulemaking by docket this time, regulated entities should not executing express preemption number and other identifying send a duplicate hardcopy of their provisions in the governing fuel information (subject heading, Federal electronic CBI submissions to DOT economy statute, 49 U.S.C. 32919, had Register date and page number). headquarters. always provided the sole codified • Explain why you agree or disagree, Please note that these modified language on CAFE preemption. Since suggest alternatives, and substitute submission procedures are only to this statutory language is self-executing, language for your requested changes. facilitate continued operations while Federal courts, as well as Federal • Describe any assumptions and maintaining appropriate social agencies, states, and local governments,4 provide any technical information and/ distancing due to COVID–19. Regular had come to understand the or data that you used. procedures for part 512 submissions fundamental operation of CAFE • If you estimate potential costs or will resume upon further notice, when preemption and applied it on a case-by- burdens, explain how you arrived at NHTSA and regulated entities case basis, resulting in the development your estimate in sufficient detail to discontinue operating primarily in of a significant body of case law, allow for it to be reproduced. telework status. without the need for any corresponding • Provide specific examples to If you have any questions about CBI regulations from NHTSA. illustrate your concerns, and suggest or the procedures for claiming CBI, Nevertheless, NHTSA finalized the alternatives. please consult the person identified in SAFE I Rule in 2019 to prevent what the • Explain your views as clearly as the FOR FURTHER INFORMATION CONTACT Agency then perceived to be a risk of possible, avoiding the use of profanity section. regulatory uncertainty and disharmony or personal threats. resulting from an overlap in state motor (5) How can I read the comments • Make sure to submit your vehicle GHG emissions regulations and submitted by other people? comments by the comment period ZEV mandates and NHTSA’s fuel deadline identified in the DATES section You may read the materials placed in economy standards. In an effort to above. the docket for this document (e.g., the foreclose such perceived instability, comments submitted in response to this NHTSA promulgated regulations that (3) How can I be sure that my comments document by other interested persons) attempted to preempt ‘‘any law or were received? at any time by going to http:// regulation of a State or a political If you submit your comments by mail www.regulations.gov. Follow the online subdivision of a State regulating or and wish Docket Management to notify instructions for accessing the dockets. prohibiting tailpipe carbon dioxide you upon its receipt of your comments, You may also read the materials at the emissions from automobiles,’’ 5 enclose a self-addressed, stamped NHTSA Docket Management Facility by including state GHG standards and ZEV postcard in the envelope containing going to the street addresses given above mandates. In the SAFE I Rule, the your comments. Upon receiving your under ADDRESSES. Agency described the authority for this comments, Docket Management will B. Executive Summary sweeping act of preemption as primarily return the postcard by mail. drawn from NHTSA’s general mandate In September 2019, NHTSA and the to establish national fuel economy (4) How do I submit confidential Environmental Protection Agency (EPA) standards, rather than from any business information? finalized a joint agency action relating particular delegation of rulemaking If you wish to submit any information to the state regulation of GHG emissions authority in Section 32919.6 In the same under a claim of confidentiality, you from motor vehicles and ZEV mandates. document, EPA withdrew California’s should submit your complete In that action, NHTSA codified then-existing waiver under the Clean submission, including the information numbered regulatory text that repeated you claim to be confidential business the existing statutory provisions and, in 3 This proposed rule is being issued only by information (CBI), to the NHTSA Chief codified appendices, expressly declared NHTSA. As such, to the extent EPA subsequently that certain types of state regulation undertakes an action to reconsider the revocation of Counsel. When you send a comment California’s Section 209 waiver, such action would containing CBI, you should include a were preempted due to a perceived occur through a separate, independent proceeding. cover letter setting forth the information irreconcilable conflict with the Agency’s 4 For ease of reference, unless otherwise specified in our CBI regulation.2 In fuel economy standards. In addition, the distinguished herein, the varying levels of State addition, you should submit a copy Agency made further statements regulatory entities encompassed by the phrase State or a political subdivision of a State are encapsulated from which you have deleted the throughout the rule’s preamble that in the term ‘‘States’’ as used in the remainder of this claimed CBI to the Docket by one of the attempted to categorically label existing document. methods set forth above. state regulations—particularly those 5 See 49 CFR part 531, app. B (a)(2); 49 CFR part To facilitate social distancing due to from the State of California—as 533, app. B (a)(2). 6 COVID–19, NHTSA is treating preempted under the codified See NHTSA, EPA, The Safer Affordable Fuel- Efficient (SAFE) Vehicles Rule Part One: One electronic submission as an acceptable regulations and associated statutory National Program, Final Rule, 84 FR 51310, 51312 method for submitting CBI to the text. As part of the SAFE I action, EPA (Sept. 27, 2019) (‘‘To ensure that the fuel economy Agency under 49 CFR part 512. Any CBI also revoked a waiver that EPA had standards NHTSA adopts constitute the uniform previously extended to the State of national requirements that Congress intended, submissions sent via email should be NHTSA must address the extent to which State and California, under Section 209 of the local laws and regulations are preempted by 2 See 49 CFR part 512. Clean Air Act, to regulate motor vehicle EPCA.’’).

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Air Act, relying, in part, on NHTSA’s has substantial doubts about whether that this proposal would restore a clean conclusions that those programs were the Agency possessed the authority to slate for the Agency’s position on EPCA preempted by Section 32919. The final issue binding legislative rules on the preemption, which the Agency views as rule was immediately challenged in issue of EPCA preemption. Accordingly, a necessary step to ensure that such Federal court by numerous NHTSA proposes to withdraw the prior statements do not overstate stakeholders, including California, regulatory text finalized in the SAFE I NHTSA’s authority with respect to many of whom argued that NHTSA Rule. This approach realigns NHTSA to EPCA preemption issues. exceeded its authority in promulgating its historical practice: For the entire In addition, this approach will ensure the preemption regulations.7 history of the program until SAFE I was that any overstated or legally tenuous On January 20, 2021, President Biden finalized, NHTSA had administered the statements from the SAFE I Rule do not signed Executive Order 13990, CAFE program without codifying any impede NHTSA from carefully ‘‘Protecting Public Health and the such preemption regulations. reassessing its substantive views on Environment and Restoring Science To In addition, to the extent that the EPCA preemption and, if warranted, to Tackle the Climate Crisis,’’ which, Preambles in the SAFE I Rule contained subsequently announce those views in a among other actions, directed DOT and interpretative views that would not be new setting. Restoring a clean slate is NHTSA to immediately review and repealed if the Agency rescinded the critical because the Agency now has consider suspending, revising, or codified text, NHTSA is also proposing significant doubts about the accuracy rescinding the SAFE I Rule. to withdraw those positions. The and prudence of the substantive views Accordingly, NHTSA has conducted a Agency believes that withdrawing and espoused in the SAFE I rulemaking, comprehensive review of the SAFE I repealing these statements is including the validity of the preemption Rule and, in particular, the legality of appropriate to reaffirm the proper scope analysis and the manner in which it and need for the regulations and of NHTSA’s preemption authority and failed to account for a variety of positions that the Agency announced in to remove the uncertainty created by the considerations, including factual the SAFE I Rule. As a result of this SAFE I rule. Thus, the Agency proposes circumstances specific to policies that review, NHTSA now has substantial to categorically repeal both the codified would be affected by the Rule and doubts about whether the SAFE I Rule regulatory text and the interpretative important federalism interests. was a proper exercise of the Agency’s views contained in the SAFE I rule.8 Finally, even if NHTSA had authority statutory authority with respect to CAFE Similarly, to the extent other NHTSA to issue binding legislative rules on preemption, particularly as to whether Preambles, which preceded the SAFE I preemption, NHTSA still proposes to NHTSA had authority to define the Rule, also espoused views directly fully repeal and withdraw both these scope of EPCA preemption through defining EPCA preemption under regulations and any interpretative positions. After observing the SAFE I legislative rules, carrying the force and Section 32919 or the Agency’s role in Rule’s effect on interested stakeholders, effect of law. Accordingly, in this such preemption, NHTSA proposes to ranging from states, regulated entities, document, NHTSA proposes to fully withdraw and repeal those statements as and the public, and considering the repeal and withdraw the codified well.9 If finalized, the Agency believes regulations, as well as any associated temporally-limited and program-specific interpretations or views on EPCA 8 The Agency anticipates that many stakeholders factual predicates underlying NHTSA’s preemption contained in the SAFE I may comment, urging the Agency to go further—not prior assertion of permanent and Rule, including in the regulatory text of merely to repeal the preemption determination, but comprehensive preemption, NHTSA no §§ 531.7, 533.7, appendices B to parts to affirmatively announce a view that State GHG longer believes that the Agency must or and ZEV programs are not preempted under EPCA. should expressly regulate preemption 531 and 533, and the Preambles. Nevertheless, the Agency deems any such First, NHTSA has significant concerns conclusions as outside the scope of this Proposal. with the force and effect of law. As that the regulations finalized in the When an agency determines that its past action such, the Agency prefers for its codified SAFE I Rule likely exceeded the transcends the legally permissible scope, the agency regulations to return to a state of silence Agency’s rulemaking authority under is obliged to realign its regulatory activities to its regarding EPCA preemption, properly authorized scope posthaste. See, e.g., EME EPCA. In the final rule, NHTSA codified Homer City Generation, L.P. v. E.P.A., 795 F.3d 118, particularly as the views on preemption regulations in the Code of Federal 134 (D.C. Cir. 2015) (noting the need for a corrective expressed in the Appendices and Regulations, which attempted to rulemaking following a determination that a prior preamble no longer necessarily reflect categorically prohibit certain state rulemaking exceeded the agency’s statutory the views of the Agency on these authority). A repeal is the fastest way to do so and 10 programs by proclaiming them is appropriate in this context, as explained below. questions. NHTSA may decide to preempted under EPCA. However, Reassessing the scope of preemption under EPCA issue interpretations or guidance at a neither EPCA’s express preemption and announcing new interpretative views regarding later point, if warranted, after further provision nor any other statutory source Section 32919 entails a more substantive inquiry consideration. appears to permit NHTSA to adopt that necessitates additional consideration and deliberation. While NHTSA may decide to C. Statutory and Regulatory legislative rules implementing express undertake such a deliberation in the future, the Background preemption under EPCA. Although Agency’s imminent concern is realigning its NHTSA’s administration of EPCA regulatory statements to their legally proper scope In 1975, Congress enacted the Energy enables the Agency to provide its and removing the uncertainty caused by the SAFE Policy and Conservation Act (EPCA), I rule. which among other goals, sought to interpretation of EPCA’s preemption 9 For instance, NHTSA has particularly identified provisions, NHTSA appears to lack the the Preambles cited at the end of this footnote as authority to conclusively determine the containing such statements. NHTSA seeks public EPCA preemption in the preamble to a final rule scope or meaning of the EPCA comments on whether there are additional setting CAFE standards); DOT, NHTSA, Average preamble statements that contain related Fuel Economy Standards for Light Trucks Model preemption clauses with the force and statements, which should be included in this list. Years 2008–2011; Final Rule, 71 FR 17566, 17654 effect of law. Therefore, NHTSA now To be clear though, the Agency is proposing to (Apr. 6, 2006) (describing NHTSA’s views of EPCA withdraw all of such statements that may appear in preemption in the preamble to a final rule setting 7 See generally Union of Concerned Scientists, et prior NHTSA Preambles, regardless of whether they CAFE standards). al. v. NHTSA, et al., No. 19–1230 (D.C. Cir.) (on are expressly cited herein. See, e.g., DOT, NHTSA, 10 As the codified text in §§ 531.7 and 533.7 February 8, 2021, the D.C. Circuit granted the Light Truck Average Fuel Economy Standards simply repeats the statute, those provisions cannot Agencies’ motion to hold the case in abeyance in Model Years 2005–07, Final Rule, 68 FR 16868, be considered to convey any distinct meaning from light of the reconsideration of the SAFE I action). 16895 (Apr. 7, 2003) (describing NHTSA’s views on the verbatim language of Section 32919.

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‘‘conserve energy supplies through of fuel economy or fuel operating Thus, the SAFE I Rule represented the energy conservation programs, and costs.’’ 18 first Agency action to ever finalize and where necessary, the regulation of For nearly 50 years after EPCA’s codify rules that purported to create a certain energy uses.’’ 11 Congress enactment, NHTSA’s own regulations binding effect on the scope of EPCA included the ‘‘improved energy remained silent regarding the scope or preemption. The Agency initially efficiency of motor vehicles’’ among the effect of preemption established by proposed the preemption regulations energy conservation and independence Section 32919. The Agency has, on finalized in the SAFE I Rule as part of objectives specifically enumerated in occasion, spoken directly on various the broader joint EPA and NHTSA the Act.12 To facilitate the enhanced aspects of the scope of EPCA rulemaking entitled, ‘‘The Safer energy efficiency of motor vehicles, preemption in an interpretative or Affordable Fuel-Efficient (SAFE) EPCA charged the DOT to ‘‘prescribe, by advisory format—most commonly in Vehicles Rule for Model Years 2021– rule, average fuel economy standards’’ preambles of CAFE standards 2026 Passenger Cars and Light 22 for various classifications of motor rulemakings, as well as in briefings in Trucks.’’ As part of this proposal, EPA vehicles.13 litigation over specific state or local also ‘‘propos[ed] to withdraw the waiver 19 granted to California in 2013 for the In establishing a statutory framework laws. On multiple occasions throughout the Agency’s history, GHG and ZEV requirements of its for fuel economy regulation, Congress 23 NHTSA has also incorporated an Advanced Clean Cars program.’’ This incorporated a provision into EPCA that proposed rule also encompassed expressly described the preemptive assessment of state motor vehicle emissions programs—including those NHTSA’s proposed CAFE and EPA’s effect of resulting fuel economy from California—into the substantive proposed GHG emissions standards for standards and requirements.14 The analysis of CAFE standards model years 2021–2026 and various wording of this provision was slightly rulemakings. For instance, these regulations regarding administrative modified in a recodification of EPCA in assessments have often occurred aspects of the CAFE and GHG 1994. Overall though, both 24 through NHTSA’s analysis of the programs. Subsequently, NHTSA and contemporaneous legislative sources regulatory landscape and existing EPA decoupled the NHTSA preemption and courts considering fuel economy automotive industry practices, which regulations and EPA’s revocation of California’s Clean Air Act waiver from matters have stressed that ‘‘the 1994 NHTSA considers when assessing the the standards rulemaking. The Agencies recodification was intended to ‘‘revise[ ], ‘‘maximum feasible’’ fuel economy that jointly published the SAFE I Rule on codif[y], and enact[ ]’’ the law ‘‘without can be achieved by manufacturers.20 15 September 27, 2019, with NHTSA substantive change.’’ As such, EPCA’s However, until the SAFE I Rule, finalizing the proposed preemption original express preemption provision NHTSA’s commentary on EPCA regulations, and EPA revoking remains codified in substantially the preemption occurred exclusively in an California’s waiver. The Agencies later same form in 49 U.S.C. 32919. The interpretative context, and the Agency jointly published a separate final rule express language of subsection (a) of had never established legally binding that set CAFE and GHG emissions Section 32919 provides that ‘‘[w]hen an requirements on states through average fuel economy standard 21 standards for model years 2021–2026 regulatory text. 25 prescribed under this chapter is in passenger cars and light trucks. The preemption language effect, a State or a political subdivision 18 49 U.S.C. 32919(b). promulgated by NHTSA in the SAFE I of a State may not adopt or enforce a 19 See, e.g., DOT, NHTSA, Light Truck Average Rule appears in several locations in the law or regulation related to fuel Fuel Economy Standards Model Years 2005–07, CFR: 49 CFR 531.7, appendix B to 49 economy standards or average fuel Final Rule, 68 FR 16868, 16895 (Apr. 7, 2003) (describing NHTSA’s views on EPCA preemption in CFR part 531, 49 CFR 533.7, and economy standards for automobiles the preamble to a final rule setting CAFE appendix B to 49 CFR part 533. The covered by an average fuel economy standards); DOT, NHTSA, Average Fuel Economy provisions in §§ 531.7 and 533.7, as well 16 standard under this chapter.’’ The Standards for Light Trucks Model Years 2008–2011; as in each appendix B, mirror one provision contains an exception, which Final Rule, 71 FR 17566, 17654 (Apr. 6, 2006) (describing NHTSA’s views of EPCA preemption in another. The only distinction in the two allows that a State or local government the preamble to a final rule setting CAFE sets of regulations is that part 531 ‘‘may prescribe requirements for fuel standards). applies to passenger automobiles and economy for automobiles obtained for 20 See, e.g., NHTSA, part 533 Average Fuel part 533 applies to light trucks. its own use.’’ 17 In addition, when a Economy Standards for Nonpassenger Automobiles, Final Rule, 42 FR 13807, 13814 (Mar. 14, 1977); Moreover, the language in §§ 531.7 and Federal fuel economy labeling or NHTSA, Light Truck Average Fuel Economy 533.7 uses nearly verbatim language as information requirement is in effect, Standards Model Years 2005–2007, Final Rule, 68 the express preemption statutory pursuant to 49 U.S.C. 32908, a State or FR 16868, 16895 (Apr. 7, 2003). provision, 49 U.S.C. 32919.26 Each local government may adopt or enforce 21 NHTSA did, in 2008, propose language very similar to that in the SAFE I Rule. See NHTSA, 22 an identical requirement on ‘‘disclosure Average Fuel Economy Standards, Passenger Cars See generally NHTSA, EPA, The Safer and Light Trucks; Model Years 2011–2015, Notice Affordable Fuel-Efficient (SAFE) Vehicles Rule for Model Years 2021–2026 Passenger Cars and Light 11 The Energy Policy and Conservation Act of of Proposed Rulemaking, 73 FR 24351 (May 2, 2008). However, NHTSA finalized only standards Trucks, Notice of Proposed Rulemaking, 83 FR 1975, Public Law 94–163, 89 Stat. 871, section 2(4) 42986 (Aug. 24, 2018). (‘‘Statement of Purposes’’). for model year 2011 through that rulemaking action 23 Id. at 42999. 12 Id. section 2(5) (‘‘Statement of Purposes’’). and chose not to finalize the proposed text regarding preemption, explaining that NHTSA ‘‘will 24 Id. 13 Id. section 502(3) (‘‘Average Fuel Economy re-examine the issue of preemption in the content 25 NHTSA, EPA, The Safer Affordable Fuel- Standards Applicable to Each Manufacturer’’). of its forthcoming rulemaking to establish Corporate Efficient (SAFE) Vehicles Rule for Model Years 14 Id. section 509 (‘‘Effect on State Law’’). Average Fuel Economy standards for 2012 and later 2021–2026 Passenger Cars and Light Trucks, Final 15 Green Mountain Chrysler Plymouth Dodge Jeep model years.’’ 74 FR 14196, 14200 (Mar. 30, 2009). Rule, 85 FR 24174 (Apr. 30, 2020). v. Crombie, 508 F. Supp. 2d 295, 346 (D. Vt. 2007) NHTSA’s subsequent joint rulemakings with EPA 26 Since the language in 49 CFR 531.7 and 533.7 (quoting Pub. L. 103–272, 108 Stat. 745, 745 (1994); prior to the SAFE rule continued to defer merely parrots the applicable statutory text, NHTSA H.R. Rep. No. 103–180, at 1 (1994), reprinted in substantive consideration of preemption due to the questions whether either provision even has a 1994 U.S.C.C.A.N. 818, 818; S. Rep. No. 103–265, existence of the National Program that involved unique effect apart from Section 32919. See at 1 (1994)). NHTSA, EPA, and California. See 75 FR 25324, Gonzales v. Oregon, 546 U.S. 243, 257 (2006) (‘‘the 16 49 U.S.C. 32919(a). 25546 (May 7, 2010); 77 FR 62624, 63147 (Oct. 15, existence of a parroting regulation does not change 17 49 U.S.C. 32919(c). 2012). Continued

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appendix B expressly codifies a and NHTSA to, ‘‘as appropriate and one.’’ 39 ‘‘[I]t suffices that the new policy prohibition on various state activities— consistent with applicable law, consider is permissible under the statute, that particularly those regulating motor suspending, revising, or rescinding’’ the there are good reasons for it, and that vehicle carbon dioxide emissions—that SAFE I Rule.32 For the SAFE I Rule, the the Agency believes it to be better, the Agency proclaimed were unlawful Executive order also instructed that the which the conscious change of course due to ‘‘express preemption’’ and Agency, ‘‘as appropriate and consistent adequately indicates.’’ 40 For instance, ‘‘implied preemption.’’ 27 with applicable law, shall consider ‘‘evolving notions’’ about the Following the promulgation of the publishing for notice and comment a appropriate balance of varying policy SAFE I Rule, the actions of both NHTSA proposed rule suspending, revising, or considerations constitute sufficiently and EPA were challenged by a number rescinding the agency action . . . by good reasons for a change in position.41 of petitioners in both the United States April 2021.’’ 33 Moreover, it is ‘‘well within an Agency’s Court of Appeals for the District of D. Reconsideration Authority discretion’’ to change policy course Columbia Circuit (D.C. Circuit) and the even when no new facts have arisen: United States District Court for the NHTSA, like any other Federal Agencies are permitted to conduct a 28 District of Columbia. The litigation agency, is afforded an opportunity to ‘‘reevaluation of which policy would be reconsider prior views and, when has substantially divided the regulated better in light of the facts,’’ without warranted, to adopt new positions. industry and interested stakeholders, as ‘‘rely[ing] on new facts.’’ 42 the D.C. Circuit litigation encompasses Indeed, as a matter of good governance, ten consolidated petitions brought by a agencies should revisit their positions NHTSA views this need to reassess its number of states, cities, and when appropriate, especially to ensure stated positions as particularly environmental organizations that their actions and regulations reflect appropriate and imperative when the challenging the rule. On the other side legally sound interpretations of the issues either implicate the limits of the of the litigation, several automakers, agency’s authority and remain Agency’s statutory authority or concern other states, and fuel and petrochemical consistent with the agency’s views and positions on critical policy issues that manufacturers have intervened in practices. As a matter of law, ‘‘an no longer necessarily reflect that support of the rule. In addition to the Agency is entitled to change its agency’s views. This is especially litigation, one public interest interpretation of a statute.’’ 34 important in matters regarding the organization, the Chesapeake Bay Nonetheless, ‘‘[w]hen an Agency adopts preemption of state law, given both the Foundation, filed a petition for a materially changed interpretation of a federalism interests at stake and because reconsideration with NHTSA following statute, it must in addition provide a ‘‘agencies have no special authority to the SAFE I Rule’s publication.29 The ‘reasoned analysis’ supporting its pronounce on pre-emption absent Chesapeake Bay Foundation decision to revise its interpretation.’’ 35 delegation by Congress.’’ 43 NHTSA subsequently filed a petition for review ‘‘Changing policy does not, on its believes that upon tentatively in the D.C. Circuit, which challenges own, trigger an especially ‘demanding determining that legal authority NHTSA’s denial of this petition for burden of justification.’ ’’ 36 Providing a previously claimed likely does not exist, reconsideration.30 In light of the reasoned explanation ‘‘would ordinarily the most responsible and legally Agencies’ reconsideration of the SAFE I demand that [the Agency] display essential course of action is for the action, the D.C. Circuit granted requests awareness that it is changing Agency to exercise its reconsideration 37 to hold both the consolidated litigation position.’’ Beyond that, however, authority to explore and, if necessary, and Chesapeake Bay Foundation’s ‘‘[w]hen an agency changes its existing rectify the potential overstep. This is the subsequent lawsuit in abeyance. position, it ‘need not always provide a precise action that NHTSA proposes On January 20, 2021, President Biden more detailed justification than what here. signed Executive Order 13990, which would suffice for a new policy created 38 directed DOT and NHTSA to on a blank slate.’ ’’ While the Agency 39 Fox Television Stations, Inc., 556 U.S. at 515 immediately undertake an assessment of ‘‘must show that there are good reasons (emphasis in original). the SAFE I Rule.31 Specifically, for the new policy,’’ the Agency ‘‘need 40 Id. (emphasis in original). Executive Order 13990 directed DOT not demonstrate to a court’s satisfaction 41 N. Am.’s Bldg. Trades Unions v. Occupational that the reasons for the new policy are Safety & Health Admin., 878 F.3d 271, 303 (D.C. better than the reasons for the old Cir. 2017) (quoting the agency’s rule). To be sure, the fact that the question here is not the meaning providing ‘‘a more detailed justification’’ is of the regulation but the meaning of the statute’’). appropriate in some cases. See Fox Television Based upon the comments received on the SAFE I 32 Id. at Sec. 2. Stations, Inc., 556 U.S. at 515 (2009) (‘‘Sometimes Rule, on further reflection, NHTSA’s view is that 33 Id. at Sec. 2–2(ii). [the agency] must [provide a more detailed this question merely augmented the uncertainty 34 Phoenix Hydro Corp. v. F.E.R.C., 775 F.2d justification than what would suffice for a new among stakeholders about the scope of EPCA 1187, 1191 (D.C. Cir. 1985). policy created on a blank slate]—when, for preemption, and further demonstrates that this 35 Alabama Educ. Ass’n v. Chao, 455 F.3d 386, example, its new policy rests upon factual findings codification was unnecessary and unhelpful. 392 (D.C. Cir. 2006) (quoting Motor Vehicle Mfrs. that contradict those which underlay its prior 27 See 49 CFR part 531, app. B; 49 CFR part 533, Ass’n of U.S., Inc. v. State Farm Mut. Auto. Ins. Co., policy; or when its prior policy has engendered app B. 463 U.S. 29, 57 (1983)); see also Encino Motorcars, serious reliance interests that must be taken into 28 See generally Union of Concerned Scientists, et LLC v. Navarro, 136 S. Ct. 2117, 2125 (2016) account.’’). This is not one of those cases: NHTSA’s al. v. NHTSA, et al., No. 19–1230 (D.C. Cir.). See (‘‘Agencies are free to change their existing policies reconsidered understanding of the governing legal also California v. Chao, No. 19–cv–2826–KBJ as long as they provide a reasoned explanation for framework does not ‘‘rest[ ] upon factual findings (D.D.C.) (filed Sept. 20, 2019). the change.’’) (citations omitted). that contradict those which underlay its prior 29 See generally Chesapeake Bay Foundation, 36 See Mingo Logan Coal Co. v. E.P.A., 829 F.3d policy.’’ Moreover, the reconsideration does not Petition for Reconsideration of NHTSA’s Final 710, 718 (D.C. Cir. 2016) (quoting Ark Initiative v. undermine ‘‘engendered serious reliance interests Rule—The Safer Affordable Fuel Efficient (SAFE) Tidwell, 816 F.3d 119, 127 (D.C. Cir. 2016)). that must be taken into account.,’’ The uncertainty Vehicles Rule Part One: One National Program 37 FCC v. Fox Television Stations, Inc., 556 U.S. associated with the SAFE I rulemaking, which is (Nov. 8, 2019). 502, 515 (2009) (emphasis in original) (‘‘An agency described further herein, has not created an 30 See generally Chesapeake Bay Foundation, Inc. may not, for example, depart from a prior policy environment in which any interested stakeholders v. NHTSA, No. 20–2091 (D.C. Cir.). sub silentio or simply disregard rules that are still could reasonably rely upon a framework that 31 Executive Order 13990, Protecting Public on the books.’’). presupposed the continuance of the SAFE I Rule. Health and the Environment and Restoring Science 38 Encino Motorcars, LLC, 136 S. Ct. at 2125–26 42 Nat’l Ass’n of Home Builders v. E.P.A., 682 to Tackle the Climate Crisis, 86 FR 7037 (Jan. 25, (quoting Fox Television Stations, Inc., 556 U.S. at F.3d 1032, 1037–38 (D.C. Cir. 2012). 2021). 515). 43 See Wyeth v. Levine, 555 U.S. 555, 577 (2009).

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E. Proposed Repeal of Regulations in an express preemption provision in Specifically, NHTSA promulgated 49 the SAFE I Rule Section 32919, the Appendices CFR 531.7 and 533.7, both of which After a comprehensive promulgated in the SAFE I Rule were nearly verbatim codifications of reconsideration of the SAFE I Rule, expressed, in more specific terms than the statutory text, and an identical NHTSA now has substantial doubts Section 32919, precise types of state appendix B to both parts 531 and 533, about whether Congress provided the regulation that would be preempted— which included a description of certain Agency with the authority necessary to namely, state efforts to regulate carbon state regulations also described as 44 dioxide emissions from motor vehicles preempted. None of these provisions engage in legislative rulemaking to 48 define the scope of preemption in 49 or to establish requirements for ZEVs. instituted any new compliance or U.S.C. 32919.45 Ultimately, ‘‘agencies These regulations purported to enforcement standards relating to expressly prohibit the conduct in have no special authority to pronounce NHTSA’s CAFE program. Instead, the on preemption absent delegation by question through their force as Federal regulations. provisions, by their own terms, solely Congress.’’ 46 Neither the language of sought to codify into NHTSA’s Section 32919 nor the broader The Agency has tentatively determined that these regulations are regulations a binding framework to regulatory structure of Chapter 329 govern the scope of EPCA preemption. provide NHTSA with the authority to legislative rules, which seek to preempt promulgate regulations with the force state regulations in more specific terms As the Preamble to the SAFE I Final and effect of law on EPCA preemption. than the express preemption provision Rule described, these provisions sought Moreover, contrary to the indications in already present in EPCA. As noted to ‘‘ma[ke] explicit that state programs the SAFE I Rule, NHTSA provisionally above, Congress included an express to limit or prohibit tailpipe GHG considers a general delegation of preemption provision in EPCA in emissions or establish ZEV mandates authority to the Secretary to ‘‘carry out’’ Section 32919. This statute expressly are preempted.’’ 52 In announcing the his ‘‘duties and powers’’ to be preempts state laws or regulations SAFE I Rule, NHTSA repeatedly ‘‘related to fuel economy standards or insufficient to support a legislative described the final rules in terms that average fuel economy standards for rulemaking that expressly administers appeared to confer upon them legally automobiles,’’ ‘‘when an average fuel preemption under Section 32919. binding connotations. For instance, the Consequently, NHTSA now proposes to economy standard prescribed under 49 Agency noted that through the final conclude that it likely overstepped its [Chapter 329] is in effect.’’ Both the Agency and courts have repeatedly rule, ‘‘NHTSA intends to assert authority in issuing binding legislative preemption’’ 53 and characterized the 47 understood Section 32919 as self- rules on preemption. Therefore, regulations as ‘‘implementing’’ 54 a NHTSA proposes to repeal each of these executing and capable of direct 50 preemption requirement. Subpart ‘‘a’’ of provisions in full to ensure that its application to state regulatory activity. each appendix B to parts 531 and 533 actions are unquestionably within the Specifically, such a direct application even labels the regulatory text as legally permissible boundaries of the involves the consideration of whether Agency’s authority. Repealing these the state regulation in question ‘‘Express Preemption’’ provisions, rules would also restore the Agency’s ‘‘relate[s] to’’ fuel economy standards before proceeding to categorically assert, previous practice, in which NHTSA did established elsewhere in Chapter 329.51 in mandatory terms, what types of state 55 not codify interpretations of EPCA The statute does not require any laws were preempted. Such a direct preemption in regulations. supplemental agency regulations to declaration of preemption, which implement this standard, nor does the purported to carry the force and effect 1. NHTSA Is Concerned That the SAFE text and structure of the statute appear of law, seeks to provide an authoritative I Rule’s Issuance of Binding, Legislative to provide NHTSA any special interpretation of the language of Section Rules on EPCA Preemption Exceeded legislative role in dictating the scope of 32919, and the regulations represented the Agency’s Authority Section 32919’s preemption. an act of legislative rulemaking that The preemption analysis begins with Accordingly, NHTSA tentatively attempted to impose more specific, consideration of the governing statute. believes that the SAFE I Rule, which binding requirements on State and local However, while EPCA already contains codified additional binding standards governments. In order to properly for express EPCA preemption, engage in such legislative rulemaking, 44 As used in this document, the term ‘‘legislative represented an additional act of express NHTSA must have adequate authority to rulemaking’’ refers to an agency’s authority to preemption beyond the self-contained do so from Congress. However, after promulgate regulations that carry the force and language of Section 32919. Through the effect of law. See, e.g., Batterton v. Francis, 432 U.S. reconsidering the matter, NHTSA has SAFE I Rule, NHTSA codified four 416, 425 (1977) (noting that when a Federal agency substantial doubts about whether it has promulgates a rule within the scope of its provisions in the CFR, each of which congressionally delegated authority, the agency purported to directly regulate the scope the requisite authority to validly ‘‘adopts regulations with legislative effect’’). of preemption under EPCA. promulgate such requirements. 45 NHTSA, EPA, The Safer Affordable Fuel- Efficient (SAFE) Vehicles Rule Part One: One National Program, Final Rule, 84 FR 51310, 51320 48 See 49 CFR part 531, app. B; 49 CFR part 533, 52 NHTSA, EPA, The Safer Affordable Fuel- (Sept. 27, 2019). app. B. Efficient (SAFE) Vehicles Rule Part One: One 46 49 49 U.S.C. 32919(a). Wyeth v. Levine, 555 U.S. 555, 577 (2009). National Program, Final Rule, 84 FR 51310 (Sept. 47 50 See, e.g., Green Mountain Chrysler Plymouth The Agency acknowledges that there may be 27, 2019). some potential ambiguity as to whether the SAFE Dodge Jeep, 508 F. Supp. at 295 (undertaking a 53 Id. at 51317. I Rule established binding legislative rules or detailed analysis of Section 32919 to determine 54 interpretative rules, as the Agency described the whether state law was preempted under the express Id. at 51318. effect of the rule in varying ways in that final rule, language of the statute). 55 See, e.g., 49 CFR part 533, app. B(a)(2) (‘‘As a particularly in its preamble. As described below, 51 See Cent. Valley Chrysler-Jeep, Inc. v. law or regulation of a State or a political NHTSA believes the SAFE I Rule was intended to Goldstene, 529 F. Supp. 2d 1151, 1175 (E.D. Cal. subdivision of a State related to fuel economy be a legislative rule. However, to the extent it is 2007), as corrected (Mar. 26, 2008) (conducting standards, any state law or regulation regulating or considered an interpretative rule, NHTSA believes such an analysis before concluding that preemption prohibiting tailpipe carbon dioxide emissions from it would still be appropriate to rescind the rule for did not exist ‘‘[g]iven the narrow scope the court automobiles is expressly preempted under 49 the reasons described in Part F, infra. must accord EPCA’s ‘‘related to’’ language’’). U.S.C. 32919.’’).

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2. Congress Must Have Provided NHTSA fact that the Board is empowered’’ in a economy standards’’ as long as a Federal With Authority To Engage in Legislative particular circumstance does not fuel economy standard is in place.66 Rulemaking on Matters of EPCA ‘‘mean[] the Board therefore enjoys such Thus, this preemption provision offers Preemption if That Rulemaking Is To Be power in every instance’’ in which a the best evidence of any possible Valid similar question arises.63 Accordingly, congressional intent to confer The legitimacy of an agency’s exercise construing an agency’s authority preemption rulemaking authority upon of preemption power through legislative requires a close examination of the NHTSA. However, the provision is rulemaking is principally a question of precise power delegated by Congress notably silent as to any role of the the extent of authority delegated to the and how such authority may differ, even agency in administering—much less agency. This is because all rulemaking if slightly, from other authority that defining—a preemption scheme. At authority of an agency ultimately Congress may reserve. most, the statute merely refers to the derives from Congress.56 As such, ‘‘in a That is, in order for an agency to issue substantive tasks of the agency to situation where state law is claimed to binding rules on preemption, the agency establish ‘‘fuel economy standard[s]’’ be pre-empted by Federal regulation, a must have the authority to directly and ‘‘requirements’’ as set forth 67 narrow focus on Congress’ intent to regulate preemption itself, rather than elsewhere in Chapter 329. Such 57 merely to establish the substantive law references only connote the core duties supersede state law [is] misdirected.’’ 64 Instead, when considering an agency’s that leads to preemption. Therefore, in borne by the agency to administer the preemptive authority, ‘‘the inquiry evaluating an agency’s authority to issue substance of the fuel economy program, becomes whether the federal agency has legislative rules on preemption, the such as by setting ‘‘maximum feasible properly exercised its own delegated proper question is whether Congress average fuel economy’’ standards under authority rather than simply whether intended the agency to define, through Section 32902 or establishing fuel Congress has properly exercised the its binding regulations, when a state law economy labeling requirements under is preempted. Only if Congress has legislative power.’’ 58 Consequently, an Section 32908. These responsibilities granted an agency that power does the agency ‘‘may act only when and how are within the agency’s traditional agency have the authority to speak with Congress lets [it].’’ 59 This restriction substantive regulatory functions, which the force of law directly on preemption. extends to all aspects of an agency’s draw from NHTSA’s technical NHTSA’s tentative conclusion, as regulatory activity—including a automobile expertise rather than any described below, is that Congress does rulemaking. The matters upon which an special agency authority over not appear to have granted NHTSA such agency may promulgate rules imbued federalism. In the Agency’s tentative authority, and that in light of this doubt, view, it seems more reasonable to with the force and effect of law are the Agency should not have issued such conclude that if Congress had intended based on its delegated authority.60 regulations in the first instance. These limitations particularly apply to give NHTSA such direct regulatory with respect to matters of preemption. 3. NHTSA Has Substantial Doubts That authority over EPCA preemption, it As the Supreme Court has made clear: EPCA Authorizes NHTSA To Issue would have done so explicitly, and Legislative Rules on Preemption likely within Section 32919 or at least A federal agency may pre-empt state law only in direct reference to preemption. when and if it is acting within the scope of EPCA does not appear to expressly Thus, the Agency is now of the view its congressionally delegated authority. This provide the authority to DOT or NHTSA that, under the language of Section is true for at least two reasons. First, an to promulgate legislative rules agency literally has no power to act, let alone 32919, the express preemption pre-empt the validly enacted legislation of a implementing or defining the scope of instituted by the statute is self-executing sovereign State, unless and until Congress the statute’s preemption. Throughout its and self-contained. This is consistent confers power upon it. Second, the best way rulemakings over the long history of the with NHTSA’s longstanding reading of of determining whether Congress intended CAFE program, NHTSA has consistently Section 32919. For instance, even the the regulations of an administrative agency to declined to construe either Section Preamble to the SAFE I Final Rule displace state law is to examine the nature 32919 or any other provision of EPCA acknowledged that the EPCA and scope of the authority granted by as expressly delegating DOT or NHTSA preemption provision of Section 32919 Congress to the agency.61 the authority to promulgate preemption was ‘‘self-executing,’’ and that ‘‘state or Since an agency lacks plenary regulations. This approach even extends local requirements related to fuel authority, the delegation of one power to the SAFE I rulemaking, in which the economy standards are void ab initio’’— to an agency does not necessarily Agency cited other statutory provisions by operation of statute not regulation.68 include other powers, even if they are for its authority to issue the rules.65 The Likewise, in the National Environmental related.62 This applies even when the Agency continues to hold this view of Policy Act of 1969 (NEPA) section of the authority is analogous. For instance, the the statute. SAFE I Rule, NHTSA expressly D.C. Circuit has rejected an agency’s Section 32919, the express disclaimed any discretion to alter the argument ‘‘that it possesses plenary preemption provision of EPCA, states preemption paradigm established by authority,’’ holding instead ‘‘that the that ‘‘a State or a political subdivision Section 32919 due to the self-sufficiency of a State may not adopt or enforce a of the statute, stressing that ‘‘[a]ny 56 Cent. United Life Ins. Co. v. Burwell, 827 F.3d law or regulation related to fuel preemptive effect resulting from this 70, 73 (D.C. Cir. 2016). final action is not the result of the 57 City of New York v. F.C.C., 486 U.S. 57, 64 63 Id. (1988). exercise of Agency discretion, but rather 64 See, e.g., City of New York, 486 U.S. at 64 58 Id. reflects the operation and application of (clarifying that ‘‘the correct focus is on the federal 69 59 Cent. United Life Ins. Co., 827 F.3d at 73. agency that seeks to displace state law and on the the Federal statute.’’ As such, the 60 See, e.g., Adams Fruit Co. v. Barrett, 494 U.S. proper bounds of its lawful authority to undertake 638, 650 (1990) (determining that a Department of such action.’’). 66 49 U.S.C. 32919. Labor regulation exceeded the scope of authority 65 See NHTSA, EPA, The Safer Affordable Fuel- 67 See 49 U.S.C. 32919(a)–(b). delegated by a statute the agency administered). Efficient (SAFE) Vehicles Rule Part One: One 68 NHTSA, EPA, The Safer Affordable Fuel- 61 Louisiana Pub. Serv. Comm’n v. F.C.C., 476 National Program, Final Rule, 84 FR 51310, 51320 Efficient (SAFE) Vehicles Rule Part One: One U.S. 355, 374 (1986). (Sept. 27, 2019) (citing other statutory provisions National Program, Final Rule, 84 FR 51310, 51325 62 Ry. Labor Executives’ Ass’n., 29 F.3d at 670 (en applicable to DOT for the requisite rulemaking (Sept. 27, 2019). banc). authority). 69 Id. at 51353–54.

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Agency again characterized any As these other statutory provisions authority.76 In the SAFE I Final Rule’s ‘‘preempted standards [as] void ab demonstrate, Congress understands how most direct discussion of the issue of initio’’ due to the non-discretionary and to incorporate legislative rulemaking authority to promulgate regulations independent application of Section authority for an agency expressly and concerning preemption, NHTSA linked 32919.70 Due to the express language of directly into a statutory framework for the perceived conflict between EPCA’s Section 32919, NHTSA continues to preemption—and, in fact, exercised this purposes and state regulation to the believe that the provisions of Section prerogative elsewhere in EPCA. These general delegation of authority to the 32919 are self-executing. Consequently, responsibilities range from charging an Secretary to carry out his duties. the Agency has substantial doubts about agency to promulgate clarifying Specifically, after describing Section the validity of its prior conclusion that regulations on the applicability of 322 as an express authorization for the Congress provided rulemaking authority preemption to instructing an agency to Secretary of Transportation ‘‘to to the Agency to further codify establish an administrative procedure to prescribe regulations to carry out her preemption requirements. In reaching adjudicate exemptions of state law. duties and powers,’’ and noting that this tentative conclusion, NHTSA notes Moreover, as 49 U.S.C. 31141 Chapter 329 of Title 49 delegated the that the structures of other parts of demonstrates, when Congress decides to Secretary’s authority to NHTSA for EPCA, as well as other Federal statutes, incorporate an agency into the EPCA purposes, the Agency concluded expressly charge an agency to preemption determination process, the in the SAFE I Rule that it ‘‘ha[d] clear administer preemption through grant of authority is often not authority to issue this regulation under regulations, and no such charge exists accomplished through an indeterminate 49 U.S.C. 32901 through 32903 to for NHTSA. For example, a precursor to delegation, but instead, through an effectuate a national automobile fuel the Department of Energy, the Federal intricate and comprehensive description economy program unimpeded by Energy Administration, was expressly of the agency’s precise role in prohibited State and local directed elsewhere in EPCA to administering the preemption provision. requirements.’’ 77 This is because the ‘‘prescribe . . . rule[s]’’ that preempt Within this statutory landscape, the Agency characterized the rulemaking as state and local appliance-efficiency total silence of Section 32919 as to any simply ‘‘carry[ing] out’’ the preemption standards.71 Likewise, other DOT role for NHTSA in the implementation scope of Section 32919.78 statutes expressly provide a regulatory, of preemption seems instructive. In this Upon reconsideration, NHTSA is or even adjudicatory, role for the context, it now appears to the Agency concerned that this rationale was Department in the preemption analysis. that construing Section 32919 to permit improper. Section 322 contains For instance, in the transportation of NHTSA to issue regulations with the statutory language of broad applicability hazardous materials context, 49 U.S.C. force of law that regulate and define the that extends well beyond the CAFE 5125 directs the Secretary to adjudicate scope of preemption, as the Agency did program and, indeed, well beyond applications on whether a particular in the SAFE I Rule, would be akin to NHTSA. In light of the preceding state standard is ‘‘substantially the reading an entirely new subsection into discussion, it seems especially peculiar same’’ as Federal law and, as such, the statutory provision. Congress’ failure to derive preemption authority from exempted from statutory preemption.72 to explicitly provide DOT authority to Section 322 when EPCA already Similarly, 49 U.S.C. 31141 establishes a define or otherwise regulate the scope of contains an express preemption very detailed role for DOT in reviewing CAFE preemption—despite specifically provision, which does not provide and preempting state law pertaining to incorporating an express preemption NHTSA with a role in further defining commercial motor vehicle safety.73 provision into EPCA in Section 32919— that preemption with the force and Many of the seminal cases in the casts significant doubts upon the effect of law. Since Congress already Supreme Court’s preemption Agency’s prior determination that crafted a specific provision to describe jurisprudence also concerned statutory NHTSA has legislative rulemaking EPCA preemption in Section 32919, the schemes that expressly delegated authority in matters of fuel economy more general terms of Section 322 preemption authorities to the agencies preemption. NHTSA requests comment would seem of much clearer in question.74 on these provisional views. applicability if Section 32919 had Finally, contrary to the arguments otherwise delegated NHTSA certain made in the SAFE I Rule, NHTSA 70 Id. authorities or responsibilities to carry 71 The Energy Policy and Conservation Act of tentatively believes there is no other out. But as discussed above, Congress 1975, Public Law 94–163, 89 Stat. 871, section statutory source conferring legislative did not, in EPCA, appear to charge 327(b), recodified as amended at 42 U.S.C. 6297(d). rulemaking authority on the Agency in NHTSA with any authority or 72 49 U.S.C. 5125(d). The Secretary has delegated matters of fuel economy preemption. In responsibility with respect to this responsibility to another DOT operating the SAFE I rulemaking, NHTSA did not administration, the Pipeline and Hazardous preemption regulations. Construing Materials Safety Administration (PHMSA). claim that its authority to issue Section 322’s general terms to 73 See 49 U.S.C. 31141 (expressly stating that ‘‘[a] preemption regulations derived from independently provide NHTSA with the State may not enforce a State law or regulation on Section 32919.75 Instead, NHTSA authority to issue legislative rules on commercial motor vehicle safety that the Secretary concluded that its authority arose of Transportation decides under this section may EPCA preemption that override Section not be enforced’’ before enumerating multiple implicitly from EPCA, because the 32919’s notable silence as to any role for subsections that define an adjudicatory role for the Agency argued that it could not carry NHTSA would require an DOT, complete with preemption standards and out its CAFE standard-setting extraordinarily expansive reading of procedures). The Secretary has delegated this responsibilities in the face of state responsibility to another DOT operating Section 322. administration, the Federal Motor Carrier Safety regulation that undermined its Moreover, even apart from Section Administration (FMCSA). 322, general inferences drawn from the 74 For example, in a set of cases evaluating the generally Lohr, 518 U.S. at 470 (plurality opinion); broad purposes of EPCA do not seem preemption of certain state tort law relating to Riegel v. Medtronic, Inc., 552 U.S. 312 (2008). See capable of contravening a clear reading medical device product liability, the Supreme Court also 21 U.S.C. 360k; 21 CFR 808.1. analyzed U.S. Food and Drug Administration (FDA) 75 See generally NHTSA, EPA, The Safer regulations that specifically defined when Affordable Fuel-Efficient (SAFE) Vehicles Rule Part 76 See, e.g., id. at 51317. preemption occurred under the applicable statute, One: One National Program, Final Rule, 84 FR 77 Id. at 51320. the Medical Device Amendments (MDA). See 51310, 51320 (Sept. 27, 2019). 78 Id.

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of the express preemption provision in requirements. The Agency now sought to preempt these precise state Section 32919. As described above, the recognizes that implied preemption, programs. Consequently, NHTSA SAFE I Rule argued that regulation was which arises primarily in a judicial considers such examples and needed to resolve a perceived context, involves principles that are substantive positions as inextricably irreconcilable conflict between state most appropriately applied by reference linked to the regulatory text and, as GHG emissions regulations and ZEV to specific state programs, rather than in such, would also be rescinded upon the mandates and EPCA’s delegation of the abstract and categorical manner of proposed removal of the regulations. authority to NHTSA to set national fuel the SAFE I Rule’s regulations.82 While However, to be abundantly clear, economy standards.79 However, even NHTSA still retains interpretative NHTSA is also proposing in this assuming that is true, the statutory authority to set forth its advisory views provision on preemption provides no on whether a state regulation document to repeal any interpretative role for NHTSA to speak on this issue impermissibly conflicts with Federal positions regarding EPCA preemption with the force and effect of law. The law, such authority does not support the that may be contained within the Agency does not believe that a proper power to codify binding legislative rules Preambles of the SAFE I NPRM and statutory reading permits this on the matter. Final Rule regardless of whether they unambiguous silence in Section 32919 Thus, upon reconsideration, NHTSA are linked to the codified text. This to be overridden by intangible has substantial doubts about its includes any views on whether inferences extrapolated from EPCA authority to issue legislative rules particular state motor vehicle GHG generally.80 concerning EPCA preemption. Thus, the emissions programs or ZEV mandates Likewise, upon reconsideration, SAFE I Rule’s effort to establish such conflict with or ‘‘relate to’’ CAFE NHTSA does not consider any such rules likely exceeded the Agency’s standards or are otherwise preempted general inferences as appropriately authority. For this reason, and for the by Section 32919. Given the Agency’s addressed through the categorical additional reasons discussed herein, concerns about the lack of legislative rulemaking actions of the SAFE I Rule. NHTSA is now of the view that the rulemaking authority on matters of For example, a substantial portion of the SAFE I Rule rests upon an infirm EPCA preemption, any surviving SAFE I Rule drew from principles of foundation and should be repealed. We substantive views on the topic would implied conflict preemption, seeking to seek comment on this tentative constitute, at most, interpretative label state regulation as preempted due determination. rules.84 As such, their repeal would not to an irreconcilable conflict with require the notice and comment Federal CAFE standards. Moreover, at F. Proposed Repeal of Preemption procedures set forth in 5 U.S.C. 553. most, the SAFE I Rule discussed Interpretations in the SAFE I Rule Nevertheless, an agency may find it compliance technologies specific to In addition to the proposed repeals of useful and prudent to seek public only one example of state standards and the codified provisions promulgated in comment on interpretations or other one example of Federal standards.81 Yet the SAFE I Rule, NHTSA also proposes agency actions as a matter of good the SAFE I Rule sought to extrapolate to rescind the accompanying government, and NHTSA is doing so upon such a limited analysis to justify substantive analysis in the Preambles of here. Due to the anticipated substantial a pronouncement of preemption for any the Proposed and Final SAFE I Rules— state greenhouse gas standards or ZEV including positions on California’s GHG public interest in this action, NHTSA’s and ZEV programs. Descriptions of interest in gaining a broad array of 79 NHTSA, EPA, The Safer Affordable Fuel- California’s GHG and ZEV regulations, perspectives on its change in course, Efficient (SAFE) Vehicles Rule Part One: One as well as regulations of states adopting and the well-established utility of notice National Program, Final Rule, 84 FR 51310, 51319 and comment procedures, the Agency is (Sept. 27, 2019). those regulations under Section 177 of 80 Even if such a conflict existed, it would seem the Clean Air Act, were repeatedly used still including a repeal of these to only bear upon an implied (conflict) preemption throughout the SAFE I rulemaking interpretations as part of the proposal analysis, not whether NHTSA had authority to analysis as illustrative of why the rather than immediately finalizing a promulgate binding regulations that expressly repeal of these views in this document. governed preemption. Express and implied Agency decided to codify the express preemption are district legal concepts. See, e.g., preemption text in parts 531 and 533 At this time, the Agency is not Geier v. Am. Honda Motor Co., 529 U.S. 861, 872 and their accompanying Appendices. proposing to replace any such (2000) (distinguishing between express and implied preemption). Accordingly, the SAFE I Rule’s For example, after explaining the interpretations with further views on arguments for implied (conflict) preemption cannot specific preemption regulations, the the relationship between state motor be used to bootstrap authority to regulate through Agency noted that ‘‘[i]n the proposal, vehicle GHG emissions programs or legislative rules that expressly codify mandatory NHTSA described, as an example, preemption requirements. ZEV mandates and EPCA preemption. 81 The terminology used throughout the SAFE I California’s ZEV mandate, which Instead, the Agency is exercising its rulemaking analysis mirrors the standards used by manufacturers must comply with rulemaking authority under 5 U.S.C. 551 courts to apply the judicial doctrine of implied individually for each state adopting to propose simply repealing, rather than (conflict) preemption. For instance, the SAFE I California’s mandate.’’ 83 Therefore, Preambles repeatedly invoked conflict preemption amending, any such interpretative standards—‘‘frustrates,’’ ‘‘conflicts,’’ and these substantive positions on state law positions or interpretative rules of the ‘‘interferes’’—to label state programs preempted. were presented in the SAFE I Agency. Several considerations incline See City of New York, 486 U.S. at 64 (‘‘The rulemaking as exemplary of the need for the Agency to propose repealing such statutorily authorized regulations of an agency will regulations, and the finalized text pre-empt any state or local law that conflicts with interpretations, rather than leave them such regulations or frustrates the purposes undisturbed or amend them through 82 thereof.’’) (emphasis added); See, e.g., Wyeth, 555 See, e.g., Wyeth, 555 U.S. at 576 (noting that this rulemaking. U.S. at 576 (‘‘This Court has recognized that an implied preemption principally applies after ‘‘the agency regulation with the force of law can pre- Court has performed its own conflict determination empt conflicting state requirements.’’) (emphasis relying on the substance of state and federal law 84 See, e.g., Am. Tort Reform Ass’n v. OSHA, 738 added); See, e.g., Patriotic Veterans, Inc. v. Indiana, and not on agency proclamations of pre-emption.’’). F.3d 387, 394 (D.C. Cir. 2013). In addition, the 736 F.3d 1041, 1051 (7th Cir. 2013) (describing how 83 NHTSA, EPA, The Safer Affordable Fuel- following discussion and rationales would also under the doctrine of conflict preemption, state law Efficient (SAFE) Vehicles Rule Part One: One apply to the codified text that NHTSA proposes to may be preempted ‘‘if it interferes’’ with Federal National Program, Final Rule, 84 FR 51310, 51314 repeal above if that text were determined to be an law) (emphasis added). (Sept. 27, 2019) (emphasis added). interpretative rule rather than a legislative rule.

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1. Repealing the Interpretive Provisions preemption the Agency sought to make at the time it is considering a particular Makes Clear That All Aspects of the in the Appendices. The Agency is also matter or in an advance advisory SAFE I Rule Have Been Repealed concerned that the manner in which the opinion, but it is entirely different to First, repealing the interpretations Preamble described the Agency’s role declare that such general views are treats them consistently with the with respect to EPCA preemption does incontrovertible or absolute in a way that does not account for the nuanced codified rules, which we are here not accurately reflect the limits to the and careful consideration of program- proposing for repeal. While the Agency Agency’s preemption authority specific facts called for in preemption possesses authority to issue advisory, described in the preceding section. analyses. interpretative rules on matters 2. Repealing All Aspects of the SAFE I Thus, the Agency believes that a clean pertaining to EPCA preemption, Rule Provides the Agency With a Clean slate would more appropriately enable a repealing and withdrawing the Slate on This Issue particularized consideration of how the interpretative positions of the SAFE I Further, repealing all aspects of the specifics of state programs may ‘‘relate rulemaking promotes clarity by ensuring SAFE I Rule will restore the Agency to to’’ fuel economy standards under that such views are withdrawn along a clean slate to appropriately exercise its Section 32919. Such an approach would with their accompanying regulatory interpretative discretion on matters of be more reflective of the importance of text, rather than leaving an ambiguity as EPCA preemption. In this respect, the federalism concerns and of the kind of to whether a particular statement or Agency is mindful that an program-specific factual inquiry often provision regarding EPCA preemption ‘‘administrative interpretation [which] involved in identifying whether a state remains in effect. The ambiguity alters the federal-state framework by program is preempted under the statute. regarding the legal nature and effect of permitting federal encroachment upon a This type of factual, case-specific the codified text and positions traditional state power’’ merits approach is consistent with how courts announced in the SAFE I Rule would particularly careful consideration to generally consider both the application only amplify confusion if NHTSA fully account for the significant of express preemption provisions and, proposed to repeal only parts of the federalism interests of states.88 even more so, claims of implied conflict rulemaking. Likewise, Executive Order 13132 preemption. Such courts remain The lack of clarity regarding this recognizes the importance of available to resolve issues that may arise distinction is pervasive in the SAFE I considering federalism interests, in the context of applying EPCA Rule, which often blurred the line stressing that ‘‘[t]he national preemption, such as in legal challenges between when the Agency was government should be deferential to the to particular state programs. In fact, attempting to merely articulate views on States when taking action that affects should such a legal challenge arise, this preemption under Section 32919, which the policymaking discretion of the narrower approach affords a better were merely advisory, and when States and should act only with the opportunity to provide to the presiding NHTSA sought to categorically forbid greatest caution where State or local court, if appropriate, a more tailored state action through Federal governments have identified and relevant perspective on the preemption. For example, the Preambles uncertainties regarding the Agency’s view of whether the state law to the SAFE I Rule repeatedly labeled constitutional or statutory authority of at issue is preempted. To the extent certain types of state GHG regulation the national government.’’ 89 Here, states NHTSA sets forth any such advisory and ZEV mandates as categorically have indicated that the standards at views of how EPCA preemption may preempted and prohibited, even if those issue were developed to protect the affect state programs, considering those programs were not expressly states’ residents from dangerous air programs in a more specific and narrow enumerated in the plain language of the pollution and the states’ natural context also enables the Agency to more finalized regulations. Specifically, the resources from the threats posed by fully leverage its automotive expertise Preamble to the SAFE I final rule climate change. In a number of cases, in understanding the particular vehicle unequivocally stressed that ‘‘state these policies also served as technologies implicated by the programs to limit or prohibit tailpipe components of the states’ compliance respective regulations. These same GHG emissions or establish ZEV advantages also apply if the Agency 85 with air pollution mitigation mandates are preempted,’’ and that requirements delegated to states under elects, as appropriate, to provide similar the SAFE I Rule was a ‘‘final decision the Federal Clean Air Act. views outside of the litigation context as from the agencies that States do not Upon reconsideration, NHTSA is well. The clean slate facilitated by this have the authority to set GHG standards concerned that the categorical approach is fully consistent with 86 or establish ZEV mandates.’’ At the preemption views announced in the NHTSA’s previous approach to EPCA same time, the Preamble also contained SAFE I Rule were insufficiently tailored preemption. other statements in which the Agency’s to account for these federalism interests In contrast, establishing a clean slate position is described more as an because they label an entire segment of and clearly communicating that interpretation of the scope of Section state and local regulation as preempted, NHTSA’s views on EPCA preemption, while advisory, do not independently 32919. For instance, NHTSA articulated irrespective of the precise contours of preempt, encourages states and political in the Preamble a ‘‘view . . . that ZEV any particular programs, regulations, or 87 subdivisions to more freely devise mandates are preempted by EPCA’’ technological developments that may programs that can potentially coexist The intermittent manner in which the arise. This is not to say that the Agency with Section 32919. Therefore, the Agency described the force of cannot approach the question of Agency is concerned that retaining the preemption in the Preamble whether a particular state or local law views announced in the SAFE I Rule, intermingled any interpretative is preempted without certain general and categorically foreclosing statements regarding Section 32919 with principles or overarching views, either the more binding definitions of consideration of any such programs that states may otherwise pursue, 88 See Solid Waste Agency of N. Cook Cty. v. U.S. 85 Id. at 51311. Army Corps of Engineers, 531 U.S. 159, 173 (2001). unnecessarily and inappropriately 86 Id. 89 Executive Order 13132, Federalism, Sec. 1(a) restricts potential policy innovation at 87 Id. at 51314. (Aug. 4, 1999). the State and local level.

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Further, the Agency believes that NHTSA’s express preemption in the CFR could even be confusing to repealing all aspects of the SAFE I Rule regulations. If the Agency finalizes its some, who assume some subtle and restoring a clean slate is appropriate view that the express preemption difference must exist in the statutory because the Agency has substantial regulations in parts 531 and 533 indeed and regulatory provisions. As such, the doubts about the substantive EPCA exceed NHTSA’s delegated authority, Agency no longer considers the two preemption conclusions reached in the repealing the ultra vires regulations provisions to offer any utility and SAFE I Rule. The proposal, final rule, quickly is imperative to restore proposes their repeal. As for the and ensuing litigation for the SAFE I NHTSA’s regulations to their properly remaining two Appendices and Rule generated an extensive array of authorized scope, which remains associated Preamble text, the Agency public comments, scholarship, and legal NHTSA’s paramount objective in this remains concerned that, even if NHTSA briefing regarding both the procedural proposal. In contrast, broadening the possessed authority for the rulemaking, and substantive matters of EPCA scope of this proposal to include new the categorical manner in which the preemption. While NHTSA is not substantive interpretations regarding SAFE I Rule applied preemption does announcing any new substantive views EPCA’s application to state motor not appropriately account for the regarding EPCA preemption in this vehicle emissions regulations may importance of a more nuanced approach document, the Agency recognizes that significantly expand both the purview that considers state programs on a more many of these writings raised very of the Agency’s analysis and the scope particularized basis. NHTSA believes detailed and thorough arguments of public input on the proposal, and the this more nuanced approach could advocating for a different reading and time needed to complete this action. better balance federalism interests by application of Section 32919 than was Therefore, repealing but not replacing avoiding a sweeping and premature adopted by NHTSA in the SAFE I the Agency’s substantive views on prohibition of all state and local Rule.90 preemption provides the additional time programs and instead evaluating such Although the Agency does not needed to fully reconsider the issue programs more specifically. Further, propose to adopt any substantive views without leaving any implication that the NHTSA now has significant doubts in this proposal, NHTSA acknowledges statements in the SAFE I rulemaking about the validity of its preemption that these substantive arguments merit remain in effect or inappropriately analysis as applied to the specific state careful consideration and raise dampening state regulatory activity in programs discussed in SAFE I. significant doubts for the Agency as to the interim. Therefore, for both these reasons and the validity of the positions taken in Accordingly, NHTSA is proposing to the further discussion on the subject SAFE I. As long as the SAFE I Rule fully withdraw any interpretative that appears in the preceding section, statements remain in place, any statements or views espoused in the NHTSA considers a proposal to repeal opportunity for a more nuanced Preambles of the SAFE I Rule to ensure the regulations and interpretations consideration of particular state that no ambiguity exists regarding appropriate irrespective of the Agency’s programs is significantly diminished. whether the Agency continues to level of authority on preemption. Moreover, if they remained in place, the endorse such statements. Such a SAFE I views would inaccurately rescission and repeal offers the H. Rulemaking Analyses and Notices suggest that the Agency remained opportunity to establish a clean slate, in 1. Executive Order 12866, Executive certain about substantive issues for which no prior overstatements as to Order 13563, and DOT Regulatory which, in reality, the Agency harbored NHTSA’s role lead to confusion about a Policies and Procedures significant doubts and continued to party’s legal obligations or the weight reconsider. Accordingly, NHTSA the Agency’s statements should carry NHTSA has considered the impact of preliminarily believes that even if it and no interpretative statements with this rulemaking action under Executive does not yet wish to articulate new which the Agency may no longer agree Order 12866, Executive Order 13563, substantive views, withdrawing any could influence state actions. and the Department of Transportation’s regulatory policies and procedures. This interpretations from the SAFE I Rule is G. Repealing the Regulations and a necessary and appropriate next step to rulemaking document has been Positions Announced in the SAFE I considered a ‘‘significant regulatory ensure the Agency can fully exercise its Rulemaking Remains Appropriate Even interpretative and policymaking action’’ under Executive Order 12866. if NHTSA Possessed the Authority for At this stage, NHTSA does not believe discretion to do so in a more nuanced the Rulemaking and careful way at a later point, if that this rulemaking would be warranted. Even apart from the Agency’s ‘‘economically significant,’’ as it would Due to these concerns, the Agency has substantial concerns discussed above, not directly reinstate any state programs tentatively determined that it is the Agency is also proposing a complete or otherwise affect the self-executing appropriate to first repeal the repeal of the codified provisions and statutory preemption framework in 49 interpretative positions, rather than also interpretative views as independently U.S.C. 32919. worthwhile steps. Upon to include a new interpretation in this 2. Regulatory Flexibility Act proposal, as doing so enables the most reconsideration, even if it could do so efficient and streamlined removal of lawfully, NHTSA no longer deems it Pursuant to the Regulatory Flexibility necessary to speak with the force and Act (5 U.S.C. 601 et seq., as amended by 90 For instance, in 2019 and 2020, Professor Greg effect of law on matters of EPCA the Small Business Regulatory Dotson with the University of Oregon School of preemption. Enforcement Fairness Act (SBREFA) of Law published two law review articles dedicated At the outset, the Agency considers 1996), whenever an agency is required entirely to the Agencies’ SAFE I rulemaking. In these articles, Professor Dotson comprehensively the codified text in §§ 531.7 and 533.7 to publish a notice of proposed analyzed applicable legislative and regulatory unnecessary, as they merely repeat the rulemaking or final rule, it must prepare history, before suggesting that Congress did not statutory text and, thus, have no effect and make available for public comment intend to preempt state GHG standards or ZEV beyond the statute simply by virtue of a regulatory flexibility analysis that mandates under Section 32919. Similar conclusions have been reached by other commenters and their codification in NHTSA’s describes the effect of the rule on small litigants in the SAFE I rulemaking and consolidated regulations. In fact, NHTSA is entities (i.e., small businesses, small litigation. concerned that their verbatim recitation organizations, and small governmental

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jurisdictions). No regulatory flexibility 4. Unfunded Mandates Reform Act of Federal agencies.97 If NHTSA were to analysis is required, however, if the 1995 conclude in its final rule that it lacked head of an agency certifies the proposal The Unfunded Mandates Reform Act authority to issue regulations mandating will not have a significant economic of 1995, Public Law 104–4, requires preemption or otherwise categorically impact on a substantial number of small agencies to prepare a written assessment proclaiming state regulations to be entities. of the cost, benefits and other effects of preempted, it must therefore conclude that NEPA does not apply to this action. NHTSA has considered the impacts of proposed or final rules that include a The Agency also notes that the this document under the Regulatory Federal mandate likely to result in the Supreme Court has characterized an Flexibility Act and certifies that this expenditure by State, local, or tribal rulemaking will not have a significant express preemption statue’s scope as a governments, in the aggregate, or by the legal matter of statutory construction, in economic impact on a substantial private sector, of more than $100 number of small entities. The following which ‘‘the purpose of Congress is the million annually. Because this ultimate touchstone of pre-emption provides the factual basis for this rulemaking is not expected to include a certification under 5 U.S.C. 605(b). This analysis.’’ Cipollone v. Liggett Grp., Inc., Federal mandate, no unfunded mandate 505 U.S. 504, 516 (1992). In turn, proposed action would only concern the assessment will be prepared. question of preemption; the action does ‘‘Congress’ intent, of course, primarily is not set CAFE or emissions standards 5. National Environmental Policy Act discerned from the language of the pre- emption statute and the ‘statutory themselves. The preemption regulations The National Environmental Policy framework’ surrounding it.’’ Lohr, 518 at issue in this proposal have no direct Act of 1969 (NEPA) 94 directs that U.S. at 485–86 (plurality opinion). This effect on any private entities, regardless Federal agencies proposing ‘‘major particularly applies ‘‘[i]f the statute of size, because the rules do not regulate Federal actions significantly affecting contains an express pre-emption private entities. Thus, any effect on the quality of the human environment’’ clause[. Then] the task of statutory entities implicated by this regulatory must, ‘‘to the fullest extent possible,’’ construction must in the first instance flexibility analysis is merely indirect. prepare ‘‘a detailed statement’’ on the focus on the plain wording of the environmental impacts of the proposed 3. Executive Order 13132 (Federalism) clause, which necessarily contains the action (including alternatives to the best evidence of Congress’ pre-emptive Executive Order 13132 requires proposed action).95 However, there are intent.’’ CSX Transp., Inc. v. NHTSA to develop an accountable some instances where NEPA does not Easterwood, 507 U.S. 658, 664 (1993). process to ensure ‘‘meaningful and apply to a particular proposed action. In light of this background, as both timely input by State and local officials One consideration is whether the this proposal and the SAFE I Rule itself in the development of regulatory action is a non-discretionary action to consistently made clear, the statutory policies that have federalism which NEPA may not apply.96 In this 91 text of 49 U.S.C. Section 32919 governs implications.’’ ‘‘Policies that have document, NHTSA has expressed its express preemption through self- federalism implications’’ is defined in substantial concerns over whether executing terms. Specifically, the the Executive order to include Congress provided legislative Preamble to the SAFE I Final Rule regulations that have ‘‘substantial direct rulemaking authority to the Agency stressed that ‘‘[a]ny preemptive effect effects on the States, on the relationship with regard to 49 U.S.C. 32919. To the resulting from this final action is not the between the national government and extent that the SAFE I Rule purported result of the exercise of Agency the States, or on the distribution of to dictate or proclaim EPCA preemption discretion, but rather reflects the power and responsibilities among the with the force of law, the Agency 92 operation and application of the Federal various levels of government.’’ expresses a concern throughout this statute.’’ 98 NHTSA asserted that it did Executive Order 13132 imposes proposal that such actions exceed the not have authority to waive any aspect additional consultation requirements on Congressional grant of authority to of EPCA preemption no matter the two types of regulations that have NHTSA under EPCA. If NHTSA in fact potential environmental impacts; rather, federalism implications: (1) A regulation exceeded its authority, the Agency ‘‘preempted standards are void ab that imposes substantial direct believes that the only legally initio.’’ 99 On this basis, the Agency compliance costs, and that is not appropriate course of action would be to concluded that NEPA did not apply to required by statute; and (2) a regulation realign its regulatory activities to their 93 its action. that preempts State law. properly authorized scope by removing In this document, NHTSA does not While this proposal concerns matters the regulatory language and appendices seek to take any new substantive step or of preemption, it does not propose from the Code of Federal Regulations announce any new substantive view. either type of regulation covered by and repealing the corresponding Instead, NHTSA proposes only to Executive Order 13132’s consultation analysis of particular state GHG withdraw the SAFE I Rule, which was requirements. Rather, the action in this emissions programs in the SAFE I Rule. an action for which the Agency already proposal expressly proposes to repeal Courts have long held that NEPA does determined NEPA did not apply as the regulations and positions that sought to not apply to nondiscretionary actions by operative statute continued to govern preempt State law. Thus, this proposal any environmental effects from does not implicate the consultation 94 42 U.S.C. 4321–4347. preemption. As before, the express procedures that Executive Order 13132 95 42 U.S.C. 4332. preemption provision of Section 32919 imposes on agency regulations that 96 See Dept. of Transp. v. Public Citizen, 541 U.S. 752, 768–69 (2014) (holding that the agency need would either preempt state law or not prepare an environmental impact statement 97 See, e.g., Public Citizen, 541 U.S. 752; Milo impose substantial direct compliance (EIS) in addition to an environmental assessment Cmty. Hosp. v. Weinberger, 525 F.2d 144 (1st Cir. costs on states. (EA) and stating, ‘‘Since FMCSA has no ability 1975); State of South Dakota v. Andrus, 614 F.2d categorically to prevent the cross-border operations 1190 (8th Cir. 1980); Citizens Against Rails-to-Trails of Mexican motor carriers, the environmental v. Surface Transp. Bd., 267 F.3d 1144 (D.C. Cir. 91 Executive Order 13132, Federalism, Sec. 1(a) impact of the cross-border operations would have 2001); Sierra Club v. Babbitt, 65 F.3d 1502 (9th Cir. (Aug. 4, 1999). no effect on FMCSA’s decisionmaking—FMCSA 1995). 92 Id. at Sec. 1(a). simply lacks the power to act on whatever 98 84 FR 51310, 51353–54. 93 Id. at Sec. 6(b), (c). information might be contained in the EIS.’’). 99 Id. at 51354.

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remains enacted, in full and unchanged, Proposed Regulatory Text regulations regarding applicability of irrespective of the SAFE I Rule, this For the reasons stated in the RFDs to highly migratory species (HMS) proposal, or any subsequent final rule. preamble, the National Highway Traffic Charter/Headboat permitted vessels; and As such, even though NHTSA now Safety Administration proposes to correct references to the Atlantic Tunas expresses doubts about its substantive amend 49 CFR parts 531 and 533 as set General category permit in a section of conclusions in the SAFE I Rule and forth below. the Atlantic HMS regulations. This proposes to withdraw those views here, proposed rule would establish RFDs for the Agency continues to believe that it PART 531—PASSENGER specific days during the months of July did not and cannot dictate or define by AUTOMOBILE AVERAGE FUEL through November 2021. On an RFD, law the self-executing scope of ECONOMY STANDARDS Atlantic Tunas General category preemption under Section 32919. This permitted vessels may not fish for ■ is because of the Agency’s belief 1. The authority citation for part 531 (including catch-and-release or tag-and- continues to read as follows: expressed herein that its views on release fishing), possess, retain, land, or Section 32919, while potentially Authority: 49 U.S.C. 32902; delegation of sell BFT. On an RFD, HMS Charter/ informative and advisory, do not carry authority at 49 CFR 1.95. Headboat permitted vessels with a the force and effect of law.100 Therefore, commercial sale endorsement also are this proposal likewise would not change § 531.7 [Removed] subject to these restrictions to preclude the statutorily set scope of express ■ 2. Remove § 531.7. commercially for BFT under the General preemption and, as such, the Agency Appendix B [Removed] category restrictions and retention limits does not consider this proposal to result in any environmental impact that may ■ 3. Remove appendix B to part 531. but may still fish for, possess, retain, or arise from such preemption. land BFT when fishing recreationally PART 533—LIGHT TRUCK FUEL under applicable HMS Angling category 6. Executive Order 12988 (Civil Justice ECONOMY STANDARDS rules. Reform) ■ 4. The authority citation for part 533 DATES: Written comments must be Pursuant to Executive Order 12988, continues to read as follows: received by June 11, 2021. NMFS will ‘‘Civil Justice Reform,’’ 101 NHTSA has Authority: 49 U.S.C. 32902; delegation of hold a public hearing via conference determined that this proposed rule does authority at 49 CFR 1.95. call and webinar for this proposed rule not have any retroactive effect. on May 19, 2021, from 3 p.m. to 5 p.m. § 533.7 [Removed] For webinar registration information, 7. Paperwork Reduction Act ■ 5. Remove § 533.7. see the SUPPLEMENTARY INFORMATION In accordance with the Paperwork Appendix B [Removed] section of this document. Reduction Act of 1980, NHTSA states ■ 6. Remove appendix B to part 533. ADDRESSES: You may submit comments that there are no requirements for on this document, identified by NOAA– information collection associated with Issued on April 22, 2021, in Washington, DC, under authority delegated in 49 CFR NMFS–2021–0040, by electronic this rulemaking action. 1.81, 1.95, and 501.4 submission. Submit all electronic public 8. Privacy Act Steven S. Cliff, comments via the Federal e-Rulemaking Acting Administrator. Portal. Go to https:// Please note that anyone is able to [FR Doc. 2021–08758 Filed 5–11–21; 8:45 am] www.regulations.gov and enter ‘‘NOAA– search the electronic form of all BILLING CODE 4910–59–P NMFS–2021–0040’’ in the Search box. comments received into any of DOT’s Click on the ‘‘Comment’’ icon, complete dockets by the name of the individual the required fields, and enter or attach submitting the comment (or signing the your comments. comment, if submitted on behalf of an DEPARTMENT OF COMMERCE association, business, labor union, etc.). Comments sent by any other method, National Oceanic and Atmospheric to any other address or individual, or You may review DOT’s complete Administration Privacy Act Statement in the Federal received after the close of the comment period, may not be considered by Register published on April 11, 2000 50 CFR Part 635 (Volume 65, Number 70; Pages 19477– NMFS. All comments received are a part 78), or you may visit http://dms.dot.gov. [Docket No. 210505–0102] of the public record and will generally be posted for public viewing on List of Subjects in 49 CFR Parts 531 and RIN 0648–BK37 www.regulations.gov without change. 533 Atlantic Highly Migratory Species; All personal identifying information Fuel economy. General Category Restricted-Fishing (e.g., name, address, etc.), confidential Days business information, or otherwise 100 See supra Sec. E(3). If NHTSA did, in fact, sensitive information submitted have authority to establish the scope of preemption AGENCY: National Marine Fisheries voluntarily by the sender will be with the force and effect of law, and if the Agency Service (NMFS), National Oceanic and publicly accessible. NMFS will accept inappropriately failed to incorporate environmental Atmospheric Administration (NOAA), anonymous comments (enter ‘‘N/A’’ in considerations into its decision in the SAFE I Rule, Commerce. then establishing a clean slate and restoring the the required fields if you wish to remain scope to the status quo ante would rectify this ACTION: Proposed rule; request for anonymous). overstep. See, e.g., supra Sec. F(2). In the event comments. NHTSA is adjudged to possess such binding NMFS will hold a public hearing via authority and decides to exercise it in a future SUMMARY: NMFS is proposing to set conference call/webinar on this rulemaking, such a clean state will allow NHTSA proposed rule. For specific location, to include such environmental considerations, if Atlantic bluefin tuna (BFT) General appropriate, at that time. category restricted-fishing days (RFDs) date and time, see the SUPPLEMENTARY 101 61 FR 4729 (Feb. 7, 1996). for the 2021 fishing year; clarify the INFORMATION section of this document.

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Copies of this proposed rule and first. The baseline subquotas for each 27, 1995). In that 1995 rule, NMFS supporting documents are available time period are as follows: 29.5 mt for described ‘‘no-fishing’’ days as an from the HMS Management Division January; 277.9 mt for June through available effort control that could be website at https:// August; 147.3 mt for September; 72.2 mt used to extend the General category www.fisheries.noaa.gov/topic/atlantic- for October through November; and 28.9 time-period subquotas and provide highly-migratory-species or by mt for December. Any unused General additional inseason management contacting Larry Redd at larry.redd@ category quota rolls forward within the flexibility with regard to quota use and noaa.gov or 301–427–8503. fishing year, which coincides with the distribution and season length. NMFS FOR FURTHER INFORMATION CONTACT: calendar year, from one time period to renamed ‘‘no-fishing’’ days to be Larry Redd, Jr., [email protected], the next, and is available for use in ‘‘RFDs’’ in a 1997 rulemaking, which 301–427–8503, or Sarah McLaughlin, subsequent time periods. also included annual BFT quota specifications and effort controls (62 FR [email protected], 978–281– Background 9260. 38939, July 21, 1997). From 1995 An RFD is a day, established ahead of through 2007, NMFS set RFDs on an SUPPLEMENTARY INFORMATION: Atlantic time through a schedule published in annual basis. NMFS has not used such HMS fisheries, including BFT fisheries, the Federal Register, on which NMFS RFDs since 2007. are managed under the authority of the sets the BFT retention limit at zero for In 2019 and 2020, NMFS received Atlantic Tunas Convention Act (ATCA; certain categories of permit holders. numerous requests from Atlantic tuna 16 U.S.C. 971 et seq.) and the Specifically, on an RFD, vessels dealers, General category participants, Magnuson-Stevens Fishery permitted in the Atlantic Tunas General and members of the Atlantic HMS Conservation and Management Act category are prohibited from fishing for Advisory Panel to resume the use of (Magnuson-Stevens Act; 16 U.S.C. 1801 (including catch-and-release and tag- RFDs. These requests indicated that et seq.). The 2006 Consolidated Atlantic and-release fishing), possessing, increasing BFT catch rates in the HMS Fishery Management Plan (2006 retaining, landing, or selling BFT. General category have shortened the Consolidated HMS FMP) and its (§ 635.23(a)(2)). RFDs also apply to HMS time it takes to fill the relevant amendments are implemented by Charter/Headboat permitted vessels to subquotas, which has resulted in regulations at 50 CFR part 635. Section preclude fishing commercially under unstable markets. NMFS has also 635.27 divides the U.S. BFT quota, General category restrictions and received a number of questions about recommended by the International retention limits on those days but do not RFDs and concerns that using them Commission for the Conservation of preclude such vessels from recreational could hinder the market from operating Atlantic Tunas (ICCAT) and as fishing activity under applicable naturally, unnecessarily restrict fishing implemented by the United States, Angling category regulations, including opportunities during the fishing year, among the various domestic fishing catch-and-release and tag-and-release and may negatively affect HMS fishing categories per the allocations fishing (§ 635.23(c)(3)). tournaments for BFT by potentially established in the 2006 Consolidated NMFS may waive previously reducing General category registered HMS FMP and its amendments. Section scheduled RFDs under certain tournament participation. 635.23 specifies the retention limit circumstances. Consistent with NMFS is proposing to resume the use provisions for Atlantic Tunas General § 635.23(a)(4), NMFS may waive an RFD of RFDs for the 2021 fishing year to category permitted vessels and HMS by adjusting the daily BFT retention prevent recurrence of certain issues that Charter/Headboat permitted vessels, limit from zero up to five on specified affected the fishery in 2019 and 2020. including regarding RFDs. RFDs, after considering the inseason These issues include the shortened time In 2018, NMFS implemented a final adjustment determination criteria at to fish under the General category rule that established the U.S. BFT quota § 635.27(a)(8). This would include, subquotas that occurs when quota is and subquotas consistent with ICCAT among other things, review of dealer filled quickly, increasing numbers of Recommendation 17–06 (83 FR 51391, reports, daily landing trends, and the BFT that are landed but cannot be sold October 11, 2018). In 2020, following a availability of BFT on fishing grounds. by fishermen fishing under the General stock assessment update, ICCAT NMFS would announce any such category quota when there are large adopted Recommendation 20–06, which waiver by filing a retention limit volumes of landings in a short period, maintained the total allowable catch of adjustment with the Office of the and the resulting decreasing prices of 2,350 metric tons (mt) and the Federal Register for publication. Such BFT. NMFS is proposing an RFD associated U.S. quota. As such, as adjustments would be effective no less schedule for the 2021 fishing year, described in § 635.27(a), the current than 3 calendar days after the date of balancing these issues with other baseline U.S. quota remains 1,247.86 mt filing for public inspection with the concerns expressed about RFDs (not including the 25 mt ICCAT Office of the Federal Register. NMFS affecting market operations and fishing allocated to the United States to account also may waive previously designated opportunities noted above. NMFS has for bycatch of BFT in pelagic longline RFDs effective upon closure of the existing regulatory authority to annually fisheries in the Northeast Distant Gear General category fishery so that persons publish a notice of RFDs and to Restricted Area). The baseline quota for aboard vessels permitted in the General implement them. § 635.23(a)(2). Given the General category is 555.7 mt. Each category may conduct catch-and-release the length of time that has passed since of the General category time periods or tag-and-release fishing for BFT under NMFS last implemented RFDs in these (January, June through August, § 635.26(a). NMFS would not modify fisheries, however, NMFS is also September, October through November, the previously scheduled RFDs during requesting comments on resuming the and December) is allocated a portion of the fishing year in other ways (such as use of RFDs more generally and on the the annual General category quota. changing an RFD from one date to need for RFDs in the 2021 fishing year. Although it is called the ‘‘January’’ another, or adding RFDs). subquota, the regulations allow the NMFS originally established Proposed RFD Schedule for the 2021 General category fishery under this regulatory authority to set ‘‘no-fishing’’ Fishing Year quota to continue until the subquota is days for BFT in the General category For 2021, NMFS proposes that reached or March 31, whichever comes fishery in a 1995 rule (60 FR 38505, July persons aboard vessels permitted in the

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General category would be prohibited retention rules apply to such vessels on to respect the ground rules, and those from fishing for (including catch-and- an RFD. Rather, the regulations contain that do not may be asked to leave the release and tag-and-release fishing), various cross-references to establish webinars/conference calls. possessing, retaining, landing, or selling which retention limit applies to a vessel Classification BFT on the following days: all with an Atlantic HMS Charter/Headboat Tuesdays, Fridays, and Saturdays from permit with a commercial endorsement The NMFS Assistant Administrator July 20, 2021, through November 30, on an RFD. As such, NMFS proposes to has determined that the proposed rule is 2021, while the fishery is open. On make minor changes at § 635.23(c) to consistent with the 2006 Consolidated these designated RFDs, persons aboard explicitly clarify in the regulations that HMS FMP and its amendments, other HMS Charter/Headboat permitted when the General category is closed or provisions of the Magnuson-Stevens vessels with a commercial sale on an RFD, Charter/Headboat permitted Act, ATCA, and other applicable law, endorsement also would be prohibited vessels may only fish under the Angling subject to further consideration after from fishing commercially for BFT. category limits. NMFS is also proposing public comment. Persons aboard all HMS Charter/ to correct two references to ‘‘General This proposed rule has been Headboat permitted vessels could fish category Atlantic Tunas’’ permits in this determined to be not significant for recreationally for BFT under the section to ‘‘Atlantic Tunas General purposes of Executive Order 12866. applicable Angling category restrictions category’’ permits, consistent with the An Initial Regulatory Flexibility and retention limits. permit title name in other sections of Analysis (IRFA) was prepared, as NMFS is proposing a schedule of days the Atlantic HMS regulations. required by section 603 of the from July through November based on Request for Comments Regulatory Flexibility Act (RFA). The its review of average daily catch rate IRFA describes the economic impact NMFS is requesting comments on an data for recent years and a review of this proposed rule, if adopted, would RFD schedule for the 2021 fishing year, past years’ RFD schedules and how they have on small entities. A description of proposed under its existing regulatory worked to extend the use of the General the action, why it is being considered, authority to annually publish a notice of category quota, considering past closure and the legal basis for this action are RFDs and to implement them dates. We also considered input from contained at the beginning of this accordingly given the length of time that Atlantic tuna dealers, General category section in the preamble and in the participants, and members of the has passed since NMFS last SUMMARY section of the preamble. A implemented RFDs. However, NMFS is Atlantic HMS Advisory Panel. summary of the analysis follows. A copy also requesting comments on resuming Considering this information, NMFS of this analysis is available from NMFS believes that this schedule of Tuesday, the use of such RFDs more generally (see ADDRESSES). Friday, and Saturday RFDs should and the need for RFDs in the 2021 Section 603(b)(1) requires agencies to increase the likelihood of pacing fishing year. Comments on this describe the reasons why the action is General category landings to extend proposed rule may be submitted via fishing opportunities through a greater www.regulations.gov or at a public being considered. The purpose of this portion of the subquota periods (similar conference call/webinar. NMFS solicits proposed rulemaking is, consistent with to past RFD schedules). It would also comments on this action by June 11, the objectives of the 2006 Consolidated allow for two-consecutive-day periods 2021 (see DATES and ADDRESSES). HMS FMP and its amendments, the twice each week (Sunday–Monday; During the comment period, NMFS Magnuson-Stevens Act, ATCA, and Wednesday–Thursday) for BFT product will hold a public hearing via other applicable law, to potentially set to move through the market and also conference call and webinar for this a schedule of RFDs for the 2021 fishing allow for some commercial fishing proposed action. Requests for sign year as an effort to control for the activity each weekend (Sunday). language interpretation or other General category quota, and to extend As described above, based on auxiliary aids should be directed to General category fishing opportunities consideration of regulatory criteria at Larry Redd at [email protected] or through a greater portion of the General § 635.27(a)(8), NMFS may waive certain 301–427–8503, at least 7 days prior to category time-period subquotas than RFDs consistent with § 635.23(a)(4), the meeting. have been available in recent years. either by adjusting the retention limit The webinar/conference call will take Implementation of the proposal would upwards on a previously-scheduled place on May 19, 2021. Information for further the management goals and RFD or by waiving an RFD to allow registering and accessing the webinars objectives stated in the 2006 recreational fishing under the Angling can be found at https:// Consolidated HMS FMP and its category restrictions and retention limits www.fisheries.noaa.gov/action/ amendments. when the General category closes. Once proposed-rule-implement-general- Section 603(b)(2) of the RFA requires the schedule is set, however, NMFS category-restricted-fishing-days-2021- agencies to state the objectives of, and would not modify RFDs in other ways atlantic-bluefin-tuna. legal basis for, the proposed action. The (e.g., switching days or adding RFDs). The public is reminded that NMFS objective of this proposed rulemaking is expects participants at public webinars/ to set a schedule of RFDs for the 2021 Regulatory Clarification Regarding conference calls to conduct themselves fishing year to increase the likelihood of Applicability of RFDs to HMS Charter/ appropriately. At the beginning of each pacing General category landings to Headboat Permitted Vessels webinar/conference call, the moderator extend fishing opportunities through a Section 635.23(c) specifies the BFT will explain how the webinar/ greater portion of the subquota periods retention limits for HMS Charter/ conference call will be conducted and (similar to past RFD schedules). Headboat permitted vessels, including how and when participants can provide Additionally, this proposed rule would when such vessels with a commercial comments. NMFS representative(s) will clarify the regulations regarding sale endorsement may fish under either structure the webinars/conference calls applicability of RFDs to vessels the General category (commercial) or so that all members of the public will be permitted in the HMS Charter-Headboat Angling category (recreational) retention able to comment, if they so choose, category. The legal basis for the limits and restrictions. However, the regardless of the controversial nature of proposed rule is the Magnuson-Stevens regulations do not clearly state which the subject(s). Participants are expected Act and ATCA.

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Section 603(b)(3) of the RFA requires Compliance Act, the Marine Mammal notice for that category, for the agencies to provide an estimate of the Protection Act, the Endangered Species remainder of the fishing year, until the number of small entities to which the Act, the National Environmental Policy opening of the subsequent quota period rule would apply. NMFS established a Act, the Paperwork Reduction Act, and or until such date as specified. In recent small business size standard of $11 the Coastal Zone Management Act. This years, these closures, if needed, have million in annual gross receipts for all proposed action has been determined generally occurred toward the end of businesses in the commercial fishing not to duplicate, overlap, or conflict any particular subquota time period. industry (NAICS 11411) for RFA with any Federal rules. According to communications with compliance purposes. The Small Under section 603(c) of the RFA, dealers and fishermen, several of the Business Administration (SBA) has agencies must describe any significant high-volume HMS Atlantic tunas established size standards for all other alternatives to the proposed rule which dealers in 2019 and 2020 were limiting major industry sectors in the United accomplish the stated objectives of their purchases of BFT and buying no or States, including the scenic and applicable statutes and which minimize very few BFT (such as harpooned fish sightseeing transportation (water) sector any significant economic impact of the only) on certain days during the (NAICS code 487210), which includes proposed rule on small entities. beginning portion of the June through for-hire (charter/party boat) fishing Specifically, the RFA (5 U.S.C. August subquota time period in order to entities. The SBA has defined a small 603(c)(1)–(4)) lists four general extend the available quota until later in entity under the scenic and sightseeing categories of significant alternatives to the subperiod given market transportation (water) sector as one with assist an agency in the development of considerations. However, while these average annual receipts (revenue) of less significant alternatives. These categories actions may have prevented large than $8.0 million. Therefore, NMFS of alternatives are: (1) Establishment of numbers of BFT from entering the considers all HMS permit holders, both differing compliance or reporting market at the same time and may have commercial and for-hire, to be small requirements or timetables that take into lengthened the time before any entities because they had average account the resources available to small particular subquota was closed, because annual receipts of less than their entities; (2) clarification, consolidation, these actions were not pre-scheduled or respective sector’s standard of $11 or simplification of compliance and consistently implemented across the million and $8 million. The 2019 total reporting requirements under the rule fishery, there were negative impacts ex-vessel annual revenue for the BFT for such small entities; (3) use of experienced by some General category fishery was $9.8 million. Since a small performance rather than design and Charter/Headboat permitted business is defined as having annual standards; and, (4) exemptions from fishermen, who could not find buyers receipts not in excess of $11.0 million, coverage of the rule, or any part thereof, for their BFT. As a result, a number of each individual BFT fishing entity for small entities. BFT that normally would have been Regarding the first, second, and fourth would fall within the small business sold were not, and opportunities may categories, NMFS cannot establish definition. Thus, all of the entities not have been equitably distributed differing compliance or reporting affected by this rule are considered to be among all permitted vessels. Table 1 requirements for small entities or small entities for the purposes of the shows the number and total metric tons exempt small entities from coverage of RFA. The numbers of relevant annual (mt) of BFT that were landed but not the rule or parts of it, because all of the Atlantic Tunas or Atlantic HMS permits sold by fishermen fishing under the businesses impacted by this rule are as of October 2020 are as follows: 2,645 General category quota for 2017 through considered small entities, and thus the General category permit holders and 2020. The number and weight of unsold requirements are already designed for 3,839 HMS Charter/Headboat permit BFT has been increasing since 2017, and small entities. Regarding the third holders, of which 1,681 hold HMS increased substantially (from 20 to 173 Charter/Headboat permits with a category, NMFS does not know of any performance or design standards that BFT and 3.8 to 31.4 mt) between 2019 commercial sale endorsement. and 2020. Section 603(b)(4) of the RFA requires would satisfy the aforementioned agencies to describe any new reporting, objectives of this rulemaking. TABLE 1—THE NUMBER (COUNT) AND record-keeping, and other compliance This proposed rule would not change requirements. This proposed rule does the U.S. Atlantic BFT quotas or WEIGHT (mt) OF BFT THAT WERE not contain any new collection of implement any new management LANDED BUT UNSOLD BY GENERAL information, reporting, or record- measures not previously considered CATEGORY PARTICIPANTS BY YEAR keeping requirements. This proposed under the 2006 Consolidated HMS FMP rule would set a schedule of RFDs for and its amendments. This proposed rule Year Count Weight (mt) 2021 as an effort control for the General would instead resume use of RFDs and provide the regulated community the 2017 ...... 0 0 category quota and would clarify 2018 ...... 14 2.6 existing regulatory text about the opportunity to comment on this 2019 ...... 20 3.8 applicability of RFDs to HMS Charter/ proposal; propose a schedule of RFDs 2020 ...... 173 31.4 Headboat permitted vessels. for 2021; clarify existing regulatory text Under section 603(b)(5) of the RFA, about the applicability of RFDs to HMS Total ...... 207 37.8 agencies must identify, to the extent Charter/Headboat permitted vessels; and practicable, relevant Federal rules make a minor change to correct two In addition to reviewing the data which duplicate, overlap, or conflict permit title references in a section of the regarding the amount of unsold BFT, with the proposed action. Fishermen, regulations. Under the regulations, NMFS also reviewed the average ex- dealers, and managers in these fisheries when a General category time period vessel price. Table 2 shows the average must comply with a number of subquota is reached or projected to be ex-vessel price per pound of BFT during international agreements, domestic reached, NMFS closes the General each General category subquota time laws, and other fishery management category fishery. Retaining, possessing, period for the years 2017 through 2020. measures. These include, but are not or landing BFT under that quota On an annual basis, the ex-vessel price limited to, the Magnuson-Stevens Act, category is prohibited on and after the tends to be lower for the June through ATCA, the High Seas Fishing effective date and time of a closure August subquota time period, with an

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average (2017 through 2020) price of conditions, daily retention limits, and conditions and prices improving by the $6.04, and increases over the summer market conditions) and that in 2020, the fall. However, in 2020, the average price and fall period ($6.30 for September worsening of global market conditions per pound was lower for the June period and $6.49 for the October was an additional factor impacting the through December subquota time through November period). NMFS number of BFT unsold. These periods than in any of the three prior understands that several factors conditions generally occurred in June years. influenced dealers’ decisions to not through August 2019, and were repeated purchase BFT in 2019 (e.g., fish in June through August 2020, with

TABLE 2—AVERAGE EX-VESSEL PRICE PER POUND ($) OF BFT BY GENERAL CATEGORY SUBQUOTA TIME PERIOD [2017–2020]

Subquota time period Year October January June through September through December through March August November

2017 ...... $7.37 $6.72 $7.08 $7.56 $9.83 2018 ...... 7.43 6.92 6.55 7.58 9.56 2019 ...... 6.06 5.61 6.36 5.53 12.25 2020 ...... 6.13 4.91 5.21 5.30 5.76 2017 through 2020 average ...... 6.75 6.04 6.30 6.49 9.35

To help address these issues, NMFS is decreasing ex-vessel prices (Table 2) (2) A Charter/Headboat permit with a proposing to establish a schedule of would continue. If these trends commercial endorsement may not fish RFDs for the 2021 fishing year that continue, all participants could commercially for BFT under the General would regulate specific days on which continue to experience negative category rules, but may fish for, possess, fishing and sales will not occur. economic impacts. retain, or land BFT under the Angling Specifically, the proposed schedule This proposed rule contains no category restrictions and retention allows for two-consecutive-day periods information collection requirements limits. twice each week for BFT product to under the Paperwork Reduction Act of * * * * * move through the market while also 1995. ■ 3. In § 635.23, revise paragraphs (a)(1) allowing some commercial fishing List of Subjects in 50 CFR Part 635 and (3) and (c)(1) through (3) and add activity to occur each weekend (i.e., paragraph (c)(4) to read as follows: Sundays). Because this schedule of Fisheries, Fishing, Fishing vessels, § 635.23 Retention limits for bluefin tuna. RFDs would apply to all participants Foreign relations, Imports, Penalties, equally, NMFS anticipates that this Reporting and recordkeeping * * * * * schedule would extend fishing requirements, Statistics, Treaties. (a) * * * (1) No person aboard a vessel that has opportunities through a greater Dated: May 6, 2021. an Atlantic Tunas General category proportion of the subquota time periods Samuel D. Rauch III, permit may possess, retain, land, or sell in which they apply by spreading Deputy Assistant Administrator for a BFT in the school, large school, or fishing effort out over time. Further, to Regulatory Programs, National Marine small medium size class. the extent that the ex-vessel revenue for Fisheries Service. a BFT sold by a General or HMS * * * * * For the reasons set out in the (3) Regardless of the length of a trip, Charter/Headboat permitted vessel (with preamble, 50 CFR part 635 is proposed no more than a single day’s retention a commercial endorsement) may be to be amended as follows: limit of large medium or giant BFT may higher when a lower volume of be possessed or retained aboard a vessel domestically-caught BFT is on the PART 635—ATLANTIC HIGHLY that has an Atlantic Tunas General market at one time, the use of RFDs may MIGRATORY SPECIES category permit. On days other than result in some increase in BFT price, RFDs, when the General category is and the value of the General category ■ 1. The authority citation for part 635 open, no person aboard such vessel may continues to read as follows: subquotas could increase. Thus, continue to fish, and the vessel must although NMFS anticipates that the Authority: 16 U.S.C. 971 et seq.; 16 U.S.C. immediately proceed to port, once the same overall amount of the General 1801 et seq. applicable limit for large medium or category quota would be landed as well ■ 2. In § 635.2, revise the definition of giant BFT is retained. as the same amount of BFT landed per ‘‘Restricted-fishing day (RFD)’’ to read vessel, there may be some positive * * * * * as follows: (c) * * * impacts to the General category and (1) When fishing in the Gulf of Charter/Headboat (commercial) BFT § 635.2 Definitions. Mexico, the restrictions and retention fishery. Using RFDs may more equitably * * * * * limits applicable to the Angling category distribute opportunities across all Restricted-fishing day (RFD) is a day, specified in paragraph (b)(1) of the permitted vessels for longer durations beginning at 0000 hours and ending at section apply. within the subquota time periods. 2400 hours local time, during which a (2) When fishing other than in the If NMFS does not implement a person aboard a vessel issued: Gulf of Mexico when the fishery for the schedule, without any other changes, it (1) An Atlantic Tunas General General category is closed or on an RFD, is possible that the trends of increasing category permit may not fish for, the restrictions and retention limits numbers of unsold BFT (Table 1) and possess, retain, land, or sell a BFT; and applicable to the Angling category

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specified in paragraphs (b)(1) through section or the Angling category been issued an HMS Charter/Headboat (3) of this section apply. restrictions and retention limits as permit without a commercial sale (3) When fishing other than in the specified in paragraphs (b)(1) through endorsement permit may only fish for, Gulf of Mexico when the General (3) of this section. The size category of possess, retain, or land BFT under the category fishery is open and not on an the first BFT retained will determine Angling category restrictions and RFD, a person aboard a vessel that has whether the General category or Angling retention limits as specified in been issued an HMS Charter/Headboat category restrictions and retention limits paragraphs (b)(1) through (3) of this permit with a commercial sale apply to the vessel that day. section. endorsement may fish under either the (4) When fishing other than in the General category restrictions and Gulf of Mexico when the General * * * * * retention limits as specified in category fishery is open and not on an [FR Doc. 2021–10028 Filed 5–11–21; 8:45 am] paragraphs (a)(1) through (3) of this RFD, a person aboard a vessel that has BILLING CODE 3510–22–P

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Notices Federal Register Vol. 86, No. 90

Wednesday, May 12, 2021

This section of the FEDERAL REGISTER reading room hours are 8 a.m. to 4:30 the RMD. These measures will be listed contains documents other than rules or p.m., Monday through Friday, except in APHIS’ Fruits and Vegetables Import proposed rules that are applicable to the holidays. To be sure someone is there to Requirements (FAVIR) database, public. Notices of hearings and investigations, help you, please call (202) 799–7039 available at https://epermits.aphis. committee meetings, agency decisions and before coming. usda.gov/manual/. rulings, delegations of authority, filing of The mitigation measures identified in petitions and applications and agency FOR FURTHER INFORMATION CONTACT: Ms. the RMD include the following: statements of organization and functions are Claudia Ferguson, Senior Regulatory • examples of documents appearing in this Policy Specialist, Regulatory Only commercial consignments of section. Coordination and Compliance, Imports, mango fruit may be imported. • All growers must be registered with Regulations, and Manuals, PPQ, APHIS, the NPPO and follow operational 4700 River Road, Unit 133, Riverdale, workplan requirements for suppression DEPARTMENT OF AGRICULTURE MD 20737–1231; (301) 851–2352; of fruit flies. [email protected]. Animal and Plant Health Inspection • The NPPO must monitor the system SUPPLEMENTARY INFORMATION: Service for inspection, packing, wrapping, Background transportation, and loading of the [Docket No. APHIS–2020–0061] commodity and ensure that Under the regulations in ‘‘Subpart L— participating growers are following the Notice of Availability of a Pest Risk Fruits and Vegetables’’ (7 CFR program guidelines. Analysis for the Importation of Fresh 319.56–1 through 319.56–12, referred to • Packinghouses must be registered Mango Fruit From Colombia Into the below as the regulations), the Animal and approved by the NPPO and meet United States and Plant Health Inspection Service the requirements listed in the (APHIS) prohibits or restricts the AGENCY: Animal and Plant Health operational workplan. importation of fruits and vegetables into • Inspection Service, USDA. The NPPO is expected to maintain the United States from certain parts of program records for at least 1 year and ACTION: Notice of availability. the world to prevent plant pests from provide them to APHIS upon request. • SUMMARY: We are advising the public being introduced into or disseminated The NPPO or its designate must that we have prepared a pest risk within the United States. conduct a fruit fly trapping program for analysis that evaluates the risks Section 319.56–4 contains a the detection of Anastrepha spp. and associated with importation of fresh performance-based process for Medfly (Ceratitis capitata) at each mango fruit from Colombia into the approving the importation of fruits and production site. Details of trap United States. Based on the analysis, we vegetables that, based on the findings of placement, checking of traps, trap have determined that the application of a pest risk analysis, can be safely density, and remedial fruit fly control one or more designated phytosanitary imported subject to one or more of the measures will be included in the measures will be sufficient to mitigate five designated phytosanitary measures operational workplan. The NPPO must the risks of introducing or disseminating listed in paragraph (b) of that section. maintain an APHIS-approved quality plant pests or noxious weeds via the APHIS received a request from the control program to monitor or audit the importation of fresh mango fruit from national plant protection organization trapping program and maintain records Colombia. We are making the pest risk (NPPO) of Colombia to allow fresh of trap placement, checking of traps, analysis available to the public for mango (Mangifera indica L.) fruit into and any fruit fly captures. The trapping review and comment. the United States. As part of our records must be maintained for at least evaluation of Colombia’s request, we 1 year and provided to APHIS upon DATES: We will consider all comments have prepared a pest risk assessment that we receive on or before July 12, request. (PRA) to identify pests of quarantine • The mangos must be treated with an 2021. significance that could follow the APHIS-approved treatment for ADDRESSES: You may submit comments pathway of importation of fresh mango Anastrepha spp. fruit flies and Medfly by either of the following methods: fruit into the United States from (Ceratitis capitata). Either: • Federal eRulemaking Portal: Go to Colombia. Based on the PRA, a risk • Hot water treatment, T102–a, which www.regulations.gov. Enter APHIS– management document (RMD) was is only available for use in a 2020–0061 in the Search field. prepared to identify phytosanitary preclearance program in accordance • Postal Mail/Commercial Delivery: measures that could be applied to the with 7 CFR part 305. Each consignment Send your comment to Docket No. fresh mango fruit to mitigate the pest of fruit treated with the APHIS- APHIS–2020–0061, Regulatory Analysis risk. approved hot water treatment must be and Development, PPD, APHIS, Station We have concluded that fresh mango precleared by APHIS inspectors in 3A–03.8, 4700 River Road, Unit 118, fruit can be safely imported from Colombia. The treatment must be Riverdale, MD 20737–1238. Colombia into the United States, using carried out under the supervision and Supporting documents and any one or more of the five designated direction of APHIS and each comments we receive on this docket phytosanitary measures listed in consignment must be inspected jointly may be viewed at www.regulations.gov § 319.56–4(b). The NPPO of Colombia by APHIS and the NPPO. Treatment or in our reading room, which is located would have to enter into an operational must occur in a pest-exclusionary in Room 1620 of the USDA South workplan with APHIS that spells out the treatment facility; or Building, 14th Street and Independence daily procedures the NPPO will take to • Irradiation treatment, T105–a–1, Avenue SW, Washington, DC. Normal implement the measures identified in which requires the fruit to be irradiated

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with a minimum absorbed dose of 150 After reviewing any comments we Analysis, telephone 301–278–9282, Gray for fruit flies and follow the receive, we will announce our decision email: [email protected]. requirements of part 305. If the regarding the import status of fresh SUPPLEMENTARY INFORMATION: The approved irradiation treatment is mango fruit from Colombia in a Federal Economic Statistics Advisory applied outside the United States, each subsequent notice. If the overall Committee (the ‘‘Committee’’) was consignment of fruit must be precleared conclusions of our analysis and the established in accordance with the by APHIS inspectors in Colombia. Administrator’s determination of risk Federal Advisory Committee Act (Title Treatment must occur in a pest- remain unchanged following our 5, United States Code, Appendix 2). The exclusionary treatment facility or, if consideration of the comments, then we following provides information about irradiation is to be applied upon arrival will authorize the importation of fresh the Committee, membership, and the in the United States, each consignment mango fruit from Colombia into the nomination process. of fruit must be inspected by the NPPO United States subject to the prior to departure and accompanied by requirements specified in the RMD. Objectives and Scope of FESAC Activities a phytosanitary certificate issued by the Authority: 7 U.S.C. 1633, 7701–7772, and NPPO. Mangos intended to be irradiated 7781–7786; 21 U.S.C. 136 and 136a; 7 CFR The Committee advises the Directors in the United States must be shipped in 2.22, 2.80, and 371.3. of the Department’s statistical agencies, APHIS-approved packaging that Done in Washington, DC, this 7th day of the Bureau of Economic Analysis (BEA) prevents escape of any Anastrepha spp. May 2021. and the U.S. Census Bureau, as well as or Medfly larvae or adults. Mark Davidson, the Commissioner of the U.S. • All hot water or irradiation Department of Labor’s Bureau of Labor treatment facilities in Colombia to be Administrator, Animal and Plant Health Inspection Service. Statistics (BLS) on statistical used for mangos are subject to APHIS methodology and other technical [FR Doc. 2021–10042 Filed 5–11–21; 8:45 am] approval. APHIS reserves the right to matters related to the design, collection, require oversight visits in the event of BILLING CODE 3410–34–P tabulation, and analysis of federal pest interceptions or other problems. economic statistics. • Mango fruit must be safeguarded from exposure to Anastrepha spp. or DEPARTMENT OF COMMERCE Description of the FESAC Member Medfly from the time of treatment to Duties Bureau of Economic Analysis export. The package containing mango The Committee functions solely as an fruit may not contain any other fruit, Federal Economic Statistics Advisory advisory committee to the senior including mango fruit not qualified for Committee officials of BEA, the Census Bureau, and importation into the United States. BLS (the agencies). Important aspects of • Each consignment must be AGENCY: Bureau of Economic Analysis, the committee’s responsibilities include, inspected jointly by inspectors from U.S. Department of Commerce. but are not limited to: APHIS and the NPPO and accompanied ACTION: Notice of request for a. Recommending research to address by a phytosanitary certificate issued by nominations. important technical problems arising in the NPPO. federal economic statistics; • If more than one Ceratitis capitata SUMMARY: The Under Secretary for b. Identifying areas in which better or Anastrepha spp. or one Neosilba Economic Affairs requests nominations coordination of the agencies’ activities glaberrima is detected in a consignment, of individuals to the Federal Economic would be beneficial; the consignment may not be exported to Statistics Advisory Committee. The c. Exploring ways to enhance the the United States. Under Secretary for Economic Affairs in agencies’ economic indicators to make • Each consignment is subject to coordination with the Directors of the them timelier, more accurate, and more inspection at the U.S. ports of entry. Department’s statistical agencies, the specific to meeting changing demands In addition to these specific measures, Bureau of Economic Analysis and the and future data needs; fresh mango fruit from Colombia would U.S. Census Bureau, as well as the d. Improving the means, methods, and be subject to the general requirements Commissioner of the U.S. Department of techniques to obtain economic listed in § 319.56–3 that are applicable Labor’s Bureau of Labor Statistics will information needed to produce current to the importation of all fruits and consider nominations received in and future economic indicators; and vegetables. response to this notice, as well as from e. Coordinating, in its identification of Therefore, in accordance with other sources. The SUPPLEMENTARY agenda items, with other existing § 319.56–4(c), we are announcing the INFORMATION section of this notice academic advisory committees availability of our PRA and RMD for provides Committee and membership chartered to provide agency-specific public review and comment. Those criteria. advice, for the purpose of avoiding documents, as well as a description of DATES: Please submit nominations 30 duplication of effort. the economic considerations associated The Committee meets once or twice a with the importation of fresh mango days after publication of this notice. The Bureau of Economic Analysis will retain year, budget permitting. Additional fruit from Colombia, may be viewed on meetings may be held as deemed the Regulations.gov website or in our nominations received after this date for consideration should additional necessary by the Under Secretary for reading room (see ADDRESSES above for vacancies occur. Economic Affairs or the Designated a link to Regulations.gov and Federal Official. All Committee ADDRESSES: Please submit nominations information on the location and hours of meetings are open to the public in by email to [email protected] the reading room). You may request accordance with the Federal Advisory (subject line ‘‘2021 FESAC paper copies of these documents by Committee Act. calling or writing to the person listed Nominations’’). under FOR FURTHER INFORMATION FOR FURTHER INFORMATION CONTACT: FESAC Membership CONTACT. Please refer to the subject of Gianna Marrone, Committee FESAC will comprise approximately the analysis you wish to review when Management Official, Department of 16 members who serve at the pleasure requesting copies. Commerce, Bureau of Economic of the Secretary. Members shall be

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appointed by the Under Secretary for minority, or disabled candidates. The SUPPLEMENTARY INFORMATION: Economic Affairs in consultation with Department of Commerce Under Background the agencies. Committee members shall Secretary of Economic Affairs and the be professionals in appropriate agencies also encourage geographic On October 21, 2015, Commerce disciplines, including economists, diversity in the composition of the published the AD and CVD orders on statisticians, survey methodologists, and Committee. boltless steel shelving from China.1 On behavioral scientists who are prominent All nomination information should be September 1, 2020, the ITC instituted,2 experts in their fields, recognized for provided in a single, complete package and Commerce initiated, the first sunset their scientific, professional, and 30 days after publication of this notice. review of the Orders, pursuant to operational achievements and The Bureau of Economic Analysis will section 751(c) of the Tariff Act of 1930, objectivity. Membership will represent retain nominations received after this as amended (the Act).3 As a result of its data users with expertise from the date for consideration should additional review, Commerce determined that public sector, academia, and the private vacancies occur. revocation of the Orders would likely sector. Members will be chosen to Interested applicants should send lead to continuation or recurrence of achieve a balanced membership that their nomination package to Gianna dumping and countervailable subsidies will meet the needs of the agencies. Marrone, Committee Management and, therefore, notified the ITC of the Members shall serve as Special Official, at [email protected] magnitude of the margins and net Government Employees (SGEs) and (subject line ‘‘2021 FESAC countervailable subsidy rates likely to shall be subject to ethics rules Nominations’’). The Bureau of prevail should the Orders be revoked.4 applicable to SGEs. Economic Analysis will retain On May 5, 2021, the ITC published its A FESAC member term is three years. nominations received after this date for determination, pursuant to sections Members may serve more than one consideration should additional 751(c) and 752(a) of the Act, that term as described in the FESAC Charter, vacancies occur. revocation of the Orders would likely available at: https://apps.bea.gov/fesac/. lead to continuation or recurrence of Sabrina L. Montes, material injury to an industry in the Compensation for Members Designated Federal Official, Bureau of United States within a reasonably Members of the Committee serve Economic Analysis, Federal Economic foreseeable time.5 Statistics Advisory Committee. without compensation but may receive Scope of the Orders reimbursement for Committee-related [FR Doc. 2021–10037 Filed 5–11–21; 8:45 am] travel and lodging expenses. BILLING CODE 3510–MN–P The scope of the Orders covers boltless steel shelving units Solicitation of Nominations prepackaged for sale, with or without The Committee is currently filling one DEPARTMENT OF COMMERCE decks (boltless steel shelving). The term or more positions on the FESAC. ‘‘prepackaged for sale’’ means that, at a The Under Secretary of Economic International Trade Administration minimum, the steel vertical supports Affairs, in consultation with the [A–570–018, C–570–019] (i.e., uprights and posts) and steel agencies will consider nominations of horizontal supports (i.e., beams, braces) all qualified individuals to ensure that Boltless Steel Shelving Units necessary to assemble a completed the Committee includes the areas of Prepackaged for Sale From the shelving unit (with or without decks) experience noted above. Individuals People’s Republic of China: are packaged together for ultimate may nominate themselves or other Continuation of Antidumping Duty purchase by the end-user. The scope individuals, and professional Order and Countervailing Duty Order also includes add-on kits. Add-on kits include, but are not limited to, kits that associations and organizations may AGENCY: Enforcement and Compliance, nominate one or more qualified persons allow the end-user to add an extension International Trade Administration, shelving unit onto an existing boltless for membership on the Committee. Department of Commerce. Nominations shall state that the steel shelving unit such that the SUMMARY: As a result of the nominee is willing to serve as a member determinations by the Department of 1 and carry out the duties of the See Boltless Steel Shelving Units Prepackaged Commerce (Commerce) and the for Sale from the People’s Republic of China: Committee. A nomination package International Trade Commission (ITC) Antidumping Duty Order, 80 FR 63741 (October 21, should include the following 2015); see also Boltless Steel Shelving Units that revocation of the antidumping duty information for each nominee: Prepackaged for Sale from the People’s Republic of 1. A letter of nomination stating the (AD) and countervailing duty (CVD) China: Amended Final Affirmative Countervailing Duty Determination and Countervailing Duty Order, name, affiliation, and contact orders on boltless steel shelving units prepackaged for sale from the People’s 80 FR 63745 (October 21, 2015) (collectively, information for the nominee, the basis Orders). Republic of China (China) would likely for the nomination (i.e., what specific 2 See Boltless Steel Shelving Units Prepackaged attributes recommend him/her for lead to continuation or recurrence of for Sale from China; Institution of Five-Year service in this capacity), and the dumping, countervailable subsidies, and Reviews, 85 FR 54404 (September 1, 2020). 3 See Initiation of Five-Year (Sunset) Reviews, 85 nominee’s field(s) of experience; material injury to an industry in the United States, Commerce is publishing FR 54348 (September 1, 2020) (Notice of Initiation). 2. a biographical sketch of the 4 See Boltless Steel Shelving Units Prepackaged nominee and a copy of his/her a notice of continuation of the AD and for Sale from the People’s Republic of China: Final curriculum vitae; and CVD orders. Results of the Expedited Sunset Review of 3. the name, return address, email DATES: Applicable May 12, 2021. Antidumping Duty Order, 86 FR 59 (January 4, 2021), and accompanying Issues and Decision address, and daytime telephone number FOR FURTHER INFORMATION CONTACT: Memorandum (IDM); see also Boltless Steel at which the nominator can be Kabir Archuletta, AD/CVD Operations, Shelving Units Prepackaged for Sale from the contacted. Office V, Enforcement and Compliance, People’s Republic of China: Final Results of the The Department of Commerce Under International Trade Administration, Expedited Sunset Review of the Countervailing Duty Order, 86 FR 58 (January 4, 2021), and Secretary of Economic Affairs and the U.S. Department of Commerce, 1401 accompanying IDM. agencies encourage nominations for Constitution Avenue NW, Washington, 5 See Boltless Steel Shelving Units Prepackaged appropriately qualified female, DC 20230; telephone: (202) 482–2593. for Sale from China, 86 FR 23981 (May 5, 2021).

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extension and the original unit will incorporates both a wire deck and wire DEPARTMENT OF COMMERCE share common frame elements (e.g., two horizontal supports (taking the place of posts). The term ‘‘boltless’’ refers to the horizontal beams and braces) into a International Trade Administration steel shelving in which the vertical and single piece with tubular collars that [A–428–850] horizontal supports forming the frame slide over the posts and onto plastic are assembled primarily without the use sleeves snapped on the posts to create Thermal Paper From Germany: of nuts and bolts or screws. The vertical the finished shelving unit; Preliminary Affirmative Determination and horizontal support members for of Sales at Less Than Fair Value, • bulk-packed parts or components of boltless steel shelving are assembled by Preliminary Affirmative Determination boltless steel shelving units; and methods such as, but not limited to, of Critical Circumstances in Part, fitting a rivet, punched or cut tab or • made-to-order shelving systems. Postponement of Final Determination, other similar connector on one support Subject boltless steel shelving enters and Extension of Provisional Measures into a hole, slot or similar receptacle on under the United States through another support. The supports lock AGENCY: Enforcement and Compliance, Harmonized Tariff Schedule of the together to form the frame for the International Trade Administration, United States (HTSUS) statistical shelving unit and provide the structural Department of Commerce. subheadings 9403.20.0018, integrity of the shelving unit separate SUMMARY: The Department of Commerce 9403.20.0020, 9403.20.0025, and from the inclusion of any decking. The (Commerce) preliminarily determines 9403.20.0026, but may also enter incidental use of nuts and bolts or that thermal paper from Germany is screws to add accessories, wall anchors, through HTSUS 9403.10.0040. While being, or is likely to be, sold in the tie-bars or shelf supports does not HTSUS subheadings are provided for United States at less than fair value remove the product from scope. Boltless convenience and customs purposes, the (LTFV). The period of investigation is steel shelving units may also come written description of the scope of the October 1, 2019, through September 30, packaged as partially assembled, such as Orders is dispositive. 2020. Interested parties are invited to when two upright supports are welded Continuation of the Orders comment on this preliminary together with front-to-back supports, or determination. are otherwise connected, to form an end As a result of the determinations by DATES: Applicable May 12, 2021. unit for the frame. The boltless steel Commerce and the ITC that revocation FOR FURTHER INFORMATION CONTACT: shelving covered by the Orders may be of the Orders would likely lead to a commonly described as rivet shelving, David Goldberger, AD/CVD Operations, continuation or a recurrence of dumping Office II, Enforcement and Compliance, welded frame shelving, slot and tab and countervailable subsidies, as well as shelving, and punched rivet (quasi- International Trade Administration, material injury to an industry in the rivet) shelving as well as by other trade U.S. Department of Commerce, 1401 names. The term ‘‘deck’’ refers to the United States, pursuant to section Constitution Avenue NW, Washington, shelf that sits on or fits into the 751(d)(2) of the Act, Commerce hereby DC 20230; telephone: (202) 482–4136. orders the continuation of the Orders. horizontal supports (beams or braces) to SUPPLEMENTARY INFORMATION: provide the horizontal storage surface of U.S. Customs and Border Protection will the shelving unit. continue to collect AD and CVD cash Background The scope includes all boltless steel deposits at the rates in effect at the time This preliminary determination is shelving meeting the description above, of entry for all imports of subject made in accordance with section 733(b) regardless of: (1) Vertical support or merchandise. The effective date of the of the Tariff Act of 1930, as amended post type (including but not limited to continuation of the Orders will be the (the Act). Commerce published the open post, closed post and tubing); (2) date of publication in the Federal notice of initiation of this investigation horizontal support or beam/brace profile Register of this notice of continuation. on November 3, 2020.1 On February 25, (including but not limited to Z-beam, C- Pursuant to section 751(c)(2) of the Act 2021, Commerce postponed the beam, L-beam, step beam and cargo and 19 CFR 351.281(c)(2), Commerce preliminary determination of this rack); (3) number of supports; (4) surface intends to initiate the next five-year investigation and the revised deadline is coating (including but not limited to reviews of the Orders not later than 30 now May 5, 2021.2 For a complete paint, epoxy, powder coating, zinc and days prior to the fifth anniversary of the description of the events that followed other metallic coating); (5) number of effective date of continuation. the initiation of this investigation, see levels; (6) weight capacity; (7) shape the Preliminary Decision (including but not limited to Notification to Interested Parties Memorandum.3 A list of topics included rectangular, square, and corner units); in the Preliminary Decision These five-year sunset reviews and (8) decking material (including but not Memorandum is included as Appendix limited to wire decking, particle board, this notice are in accordance with II to this notice. The Preliminary laminated board or no deck at all); or (9) section 751(c) of the Act and published Decision Memorandum is a public the boltless method by which vertical in accordance with section 777(i)(1) of and horizontal supports connect the Act and 19 CFR 351.218(f)(4). 1 See Thermal Paper from Germany, Japan, the (including but not limited to keyhole Dated: May 6, 2021. Republic of Korea, and Spain: Initiation of Less- and rivet, slot and tab, welded frame, Than-Fair-Value Investigations, 85 FR 69580 James Maeder, (November 3, 2020) (Initiation Notice). punched rivet and clip). 2 Specifically excluded from the scope Deputy Assistant Secretary for Antidumping See Thermal Paper from Germany, Japan, the and Countervailing Duty Operations. Republic of Korea, and Spain: Postponement of are: Preliminary Determinations in the Less-Than-Fair- • Wall-mounted shelving, defined as [FR Doc. 2021–09999 Filed 5–11–21; 8:45 am] Value Investigations, 86 FR 11502. shelving that is hung on the wall and BILLING CODE 3510–DS–P 3 See Memorandum, ‘‘Decision Memorandum for does not stand on, or transfer load to, the Preliminary Determination in the Less-Than- the floor; Fair-Value Investigation of Thermal Paper from • Germany,’’ dated concurrently with, and hereby wire shelving units, which consist adopted by, this notice (Preliminary Decision of shelves made from wire that Memorandum).

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document and is on file electronically critical circumstances analysis, see the deposit rate will be equal to the via Enforcement and Compliance’s Preliminary Decision Memorandum. company-specific estimated weighted- Antidumping and Countervailing Duty average dumping margin established for All-Others Rate Centralized Electronic Service System that producer of the subject (ACCESS). ACCESS is available to Sections 733(d)(1)(ii) and 735(c)(5)(A) merchandise; and (3) the cash deposit registered users at https:// of the Act provide that in the rate for all other producers and access.trade.gov. In addition, a complete preliminary determination Commerce exporters will be equal to the all-others version of the Preliminary Decision shall determine an estimated all-others estimated weighted-average dumping Memorandum can be accessed directly rate for all exporters and producers not margin. at http://enforcement.trade.gov/frn/. individually examined. This rate shall be an amount equal to the weighted Disclosure Scope of the Investigation average of the estimated weighted- Commerce intends to disclose its The product covered by this average dumping margins established calculations and analysis performed to investigation is thermal paper from for exporters and producers interested parties in this preliminary Germany. For a complete description of individually investigated, excluding any determination within five days of any the scope of this investigation, see zero and de minimis margins, and any public announcement, or if there is no Appendix I. margins determined entirely under public announcement, within five days section 776 of the Act. of the date of publication of this notice, Scope Comments Commerce calculated an individual in accordance with 19 CFR 351.224(b). In accordance with the preamble to estimated weighted-average dumping Commerce’s regulations,4 the Initiation margin for Koehler, the only Verification Notice set aside a period of time for individually examined exporter/ As provided in section 782(i)(1) of the parties to raise issues regarding product producer in this investigation. Because Act, Commerce intends to verify the coverage (i.e., scope).5 Certain interested the only individually calculated information relied upon in making its parties commented on the scope of the dumping margin is not zero, de final determination. Normally, investigation as it appeared in the minimis, or based entirely on facts Commerce verifies information using Initiation Notice. For a summary of the otherwise available, the estimated standard procedures, including an on- product coverage comments and weighted-average dumping margin site examination of original accounting, rebuttal responses submitted on the calculated for Koehler is the margin financial, and sales documentation. record for this investigation, and assigned to all other producers and However, due to current travel accompanying discussion and analysis exporters, pursuant to section restrictions in response to the global of all comments timely received, see the 735(c)(5)(A) of the Act. COVID–19 pandemic, Commerce is Preliminary Scope Decision Preliminary Determination unable to conduct on-site verification in Memorandum.6 Commerce is not this investigation. Accordingly, we preliminarily modifying the scope Commerce preliminarily determines intend to verify the information relied language as it appeared in the Initiation that the following estimated weighted- upon in making the final determination Notice. See the scope in Appendix I to average dumping margins exist: through alternative means in lieu of an this notice. on-site verification. Estimated Methodology weighted- Public Comment average Commerce is conducting this Exporter/producer dumping Case briefs or other written comments investigation in accordance with section margin on non-scope issues may be submitted 731 of the Act. Constructed export (percent) to the Assistant Secretary for prices have been calculated in Papierfabrik August Koehler SE 2.78 Enforcement and Compliance. accordance with section 772(b) of the All Others ...... 2.78 Interested parties will be notified of the Act. Normal value is calculated in timeline for the submission of case accordance with section 773 of the Act. Suspension of Liquidation briefs and written comments at a later For a full description of the date. Rebuttal briefs, limited to issues methodology underlying the In accordance with section 733(d)(2) raised in case briefs on non-scope preliminary determination, see the of the Act, Commerce will direct U.S. issues, may be submitted no later than Preliminary Decision Memorandum. Customs and Border Protection (CBP) to seven days after the deadline date for suspend liquidation of entries of subject case briefs.7 The deadlines for Preliminary Affirmative Determination merchandise, as described in Appendix of Critical Circumstances submitting case and rebuttal briefs on I, entered, or withdrawn from scope issues are identified in the In accordance with section 733(e) of warehouse, for consumption on or after Preliminary Scope Decision the Act and 19 CFR 351.206, Commerce the date of publication of this notice in Memorandum. Note that Commerce has preliminarily finds that critical the Federal Register. Further, pursuant temporarily modified certain of its circumstances exist for Papierfabrik to section 733(d)(1)(B) of the Act and 19 requirements for serving documents August Koehler SE (Koehler), but not CFR 351.205(d), Commerce will instruct containing business proprietary the companies covered by the all-others CBP to require a cash deposit equal to information, until further notice.8 rate. For a full description of the the estimated weighted-average Pursuant to 19 CFR 351.309(c)(2) and methodology and results of Commerce’s dumping margin, as follows: (1) The cash deposit rate for the respondent 7 See 19 CFR 351.309; see also 19 CFR 351.303 4 See Antidumping Duties; Countervailing Duties, listed above will be equal to the (for general filing requirements). Final Rule, 62 FR 27296, 27323 (May 19, 1997). company-specific estimated weighted- 8 See Temporary Rule Modifying AD/CVD Service 5 See Initiation Notice. average dumping margin determined in Requirements Due to COVID–19, 85 FR 17006 6 See Memorandum, ‘‘Scope Comments Decision this preliminary determination; (2) if the (March 26, 2020); and Temporary Rule Modifying Memorandum for the Preliminary Determinations,’’ AD/CVD Service Requirements Due to COVID–19; dated concurrently with this notice (Scope exporter is not a respondent identified Extension of Effective Period, 85 FR 41363 (July 10, Comments Decision Memorandum). above, but the producer is, then the cash 2020).

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(d)(2), parties who submit case briefs or provisional measures from a four-month Appendix II—List of Topics Discussed rebuttal briefs in this investigation are period to a period not greater than six in the Preliminary Decision encouraged to submit with each months. Accordingly, Commerce will Memorandum argument: (1) A statement of the issue; make its final determination no later I. Summary (2) a brief summary of the argument; than 135 days after the date of II. Background and (3) a table of authorities. publication of this preliminary III. Period of Investigation Pursuant to 19 CFR 351.310(c), determination. IV. Scope Comments interested parties who wish to request a International Trade Commission V. Scope of the Investigation hearing, limited to issues raised in the VI. Affirmative Preliminary Determination of case and rebuttal briefs, must submit a Notification Critical Circumstances written request to the Assistant In accordance with section 733(f) of VII. Discussion of the Methodology Secretary for Enforcement and the Act, Commerce will notify the VIII. Date of Sale Compliance, U.S. Department of International Trade Commission (ITC) of IX. Product Comparisons Commerce, within 30 days after the date its preliminary determination. If the X. Constructed Export Price final determination is affirmative, the XI. Normal Value of publication of this notice. Requests XII. Currency Conversion should contain the party’s name, ITC will determine before the later of XIII. Recommendation address, and telephone number, the 120 days after the date of this number of participants, and a list of the preliminary determination or 45 days [FR Doc. 2021–09965 Filed 5–11–21; 8:45 am] issues to be discussed. Oral after the final determination whether BILLING CODE 3510–DS–P presentations at the hearing will be these imports are materially injuring, or limited to issues raised in the briefs. If threaten material injury to, the U.S. DEPARTMENT OF COMMERCE a request for a hearing is made, parties industry. will be notified of the time and date for Notification to Interested Parties International Trade Administration the hearing.9 This determination is issued and [A–469–824] Postponement of Final Determination published in accordance with sections and Extension of Provisional Measures 733(f) and 777(i)(1) of the Act and 19 Thermal Paper From Spain: Section 735(a)(2) of the Act provides CFR 351.205(c). Preliminary Affirmative Determination of Sales at Less Than Fair Value, that a final determination may be Dated: May 5, 2021. postponed until not later than 135 days Postponement of Final Determination, Christian Marsh, after the date of the publication of the and Extension of Provisional Measures preliminary determination if, in the Acting Assistant Secretary for Enforcement and Compliance. AGENCY: Enforcement and Compliance, event of an affirmative preliminary International Trade Administration, determination, a request for such Appendix I—Scope of the Investigation Department of Commerce. postponement is made by exporters who The scope of this investigation covers SUMMARY: The Department of Commerce account for a significant proportion of thermal paper in the form of ‘‘jumbo rolls’’ exports of the subject merchandise, or in and certain ‘‘converted rolls.’’ The scope (Commerce) preliminarily determines the event of a negative preliminary covers jumbo rolls and converted rolls of that thermal paper from Spain is being, determination, a request for such thermal paper with or without a base coat or is likely to be, sold in the United postponement is made by the (typically made of clay, latex, and/or plastic States at less than fair value (LTFV). The petitioners.10 Pursuant to 19 CFR pigments, and/or like materials) on one or period of investigation (POI) is October 351.210(e)(2), Commerce requires that both sides; with thermal active coating(s) 1, 2019, through September 30, 2020. (typically made of sensitizer, dye, and co- Interested parties are invited to requests by respondents for reactant, and/or like materials) on one or postponement of a final AD both sides; with or without a top coat comment on this preliminary determination be accompanied by a (typically made of pigments, polyvinyl determination. request for extension of provisional alcohol, and/or like materials), and without DATES: Applicable May 12, 2021. measures from a four-month period to a an adhesive backing. Jumbo rolls are defined FOR FURTHER INFORMATION CONTACT: period not more than six months in as rolls with an actual width of 4.5 inches or Abdul Alnoor, AD/CVD Operations, duration. more, an actual weight of 65 pounds or more, Office IV, Enforcement and Compliance, On April 14, 2021, Koehler requested and an actual diameter of 20 inches or more that Commerce postpone the final (jumbo rolls). All jumbo rolls are included in International Trade Administration, the scope regardless of the basis weight of the U.S. Department of Commerce, 1401 determination and that provisional paper. Also included in the scope are measures be extended to a period not to Constitution Avenue NW, Washington, ‘‘converted rolls’’ with an actual width of less DC 20230; telephone: (202) 482–4554. exceed six months.11 In accordance with than 4.5 inches, and with an actual basis section 735(a)(2)(A) of the Act and 19 weight of 70 grams per square meter (gsm) or SUPPLEMENTARY INFORMATION: CFR 351.210(b)(2)(ii), because: (1) The less. Background preliminary determination is The scope of this investigation covers affirmative; (2) the requesting exporter thermal paper that is converted into rolls This preliminary determination is with an actual width of less than 4.5 inches made in accordance with section 733(b) accounts for a significant proportion of and with an actual basis weight of 70 gsm or exports of the subject merchandise; and of the Tariff Act of 1930, as amended less in third countries from jumbo rolls (the Act). Commerce published the (3) no compelling reasons for denial produced in the subject countries. exist, Commerce is postponing the final The merchandise subject to this notice of initiation of this investigation determination and extending the investigation may be classified in the on November 3, 2020.1 On February 25, Harmonized Tariff Schedule of the United 2021, Commerce postponed the 9 See 19 CFR 351.310(d). States (HTSUS) under subheadings deadline for the preliminary 10 The petitioners are Appvion Operations, Inc. 4811.90.8030 and 4811.90.9030. Although and Domtar Corporation. HTSUS subheadings are provided for 1 See Thermal Paper from Germany, Japan, the 11 See Koehler’s Letter, ‘‘Koehler’s Request to convenience and customs purposes, the Republic of Korea, and Spain: Initiation of Less- Extend the Antidumping Duty Final written description of the scope of this Than-Fair-Value Investigations, 85 FR 69580 Determination,’’ dated April 14, 2021. investigation is dispositive. (November 3, 2020) (Initiation Notice).

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determination in this investigation; the 776(a) and (b) of the Act, Commerce has methodology underlying Commerce’s revised deadline is now May 5, 2021.2 preliminarily relied upon facts analysis, see the Preliminary Decision For a complete description of the events otherwise available to assign an Memorandum. that followed the initiation of this estimated weighted-average dumping Preliminary Determination investigation, see the Preliminary margin to the sole mandatory Decision Memorandum.3 A list of topics respondent in this investigation, Commerce preliminarily determines discussed in the Preliminary Decision Torraspapel S.A. (Torraspapel) because that the following estimated weighted- Memorandum is in Appendix II to this Torraspapel failed to submit a full average dumping margins exist: notice. The Preliminary Decision response to Commerce’s antidumping Memorandum is a public document and duty questionnaire. Furthermore, Dumping Exporter/producer margin is on file electronically via Enforcement Commerce is preliminarily determining (percent) and Compliance’s Antidumping and that Torraspapel failed to cooperate by Countervailing Duty Centralized not acting to the best of its ability to Torraspapel S.A ...... 41.45 Electronic Service System (ACCESS). comply with a request for information All others ...... 37.07 ACCESS is available to registered users and is using an adverse inference when at https://access.trade.gov. In addition, a selecting from among the facts Suspension of Liquidation complete version of the Preliminary otherwise available (i.e., is basing Decision Memorandum can be accessed Torraspapel’s dumping margin on total In accordance with section 733(d)(2) directly at http://enforcement.trade.gov/ adverse facts available (AFA), in of the Act, Commerce will direct U.S. frn/. accordance with section 776(b) of Act). Customs and Border Protection (CBP) to For a full description of the suspend liquidation of entries of subject Scope of the Investigation methodology underlying the merchandise, as described in the The products covered by this preliminary determination, see the Appendix I, entered, or withdrawn from investigation are thermal paper from Preliminary Decision Memorandum. warehouse, for consumption on or after Spain. For a complete description of the the date of publication of this notice in scope of this investigation, see All-Others Rate the Federal Register. Further, pursuant Appendix I. Sections 733(d)(1)(ii) and 735(c)(5)(A) to section 733(d)(1)(B) of the Act and 19 of the Act provide that, in the CFR 351.205(d), Commerce will instruct Scope Comments preliminary determination, Commerce CBP to require a cash deposit equal to In accordance with the Preamble to shall determine an estimated all-others the estimated weighted-average Commerce’s regulations,4 in the rate for all exporters and producers not dumping margin or the estimated all- Initiation Notice we set aside a period individually examined. This rate shall others rate, as follows: (1) The cash of time for parties to raise issues be equal to the weighted average of the deposit rate for the respondent listed regarding product coverage (i.e., scope).5 estimated weighted-average dumping above will be equal to the company- Certain interested parties commented on margins established for exporters and specific estimated weighted-average the scope of the investigation as it producers individually investigated, dumping margin determined in this appeared in the Initiation Notice. For a excluding any zero and de minimis preliminary determination; (2) if the summary of the product coverage dumping margins, and any dumping exporter is not a respondent identified comments and rebuttals submitted on margins determined entirely under above, but the producer is, then the cash the record of this investigation, and section 776 of the Act. deposit rate will be equal to the accompanying discussion and analysis Pursuant to section 735(c)(5)(B) of the company-specific estimated weighted- of all comments timely received, see the Act, if the estimated weighted-average average dumping margin established for Preliminary Scope Decision dumping margins established for all that producer of the subject Memorandum.6 Commerce is not exporters and producers individually merchandise; and (3) the cash deposit preliminarily modifying the scope examined are zero, de minimis or rate for all other producers and language as it appeared in the Initiation determined based entirely on facts exporters will be equal to the all-others Notice. See the scope in Appendix I to otherwise available, Commerce may use this notice. any reasonable method to establish the accompanying Issues and Decision Memorandum at estimated weighted-average dumping Comment 2; see also Notice of Final Determination Methodology of Sales at Less Than Fair Value: Raw Flexible margin for all-other producers or Magnets from Taiwan, 73 FR 39673, 39674 (July 10, Commerce is conducting this exporters. Commerce has preliminarily 2008); Steel Threaded Rod from Thailand: investigation in accordance with section determined the estimated weighted- Preliminary Determination of Sales at Less Than 731 of the Act. Pursuant to sections average dumping margin for the sole Fair Value and Affirmative Preliminary Determination of Critical Circumstances, 78 FR mandatory respondent, Torraspapel, 79670, 79671 (December 31, 2013), unchanged in 2 See Thermal Paper from Germany, Japan, the under section 776 of the Act. Steel Threaded Rod from Thailand: Final Republic of Korea, and Spain: Postponement of Determination of Sales at Less Than Fair Value and Preliminary Determinations in the Less-Than-Fair- Consequently, pursuant to section Affirmative Final Determination of Critical Value Investigations, 86 FR 11502 (February 25, 735(c)(5)(B) of the Act, Commerce’s Circumstances, 79 FR 14476, 14477 (March 14, 2021). normal practice under these 2014); Petitioners’ Letter, ‘‘Petitions for the 3 See Memorandum, ‘‘Decision Memorandum for circumstances has been to calculate the Imposition of Antidumping Duties on Imports of the Preliminary Determination in the Less-Than- ‘‘all-others’’ ’ rate as a simple average of Thermal Paper From Germany, Japan, Korea, and Fair-Value Investigation of Thermal Paper from Spain,’’ dated October 7, 2020 at Volume V; Spain,’’ dated concurrently with, and hereby the alleged dumping margins from the 7 Petitioners’ Letter, ‘‘Response of Petitioners to adopted by, this notice (Preliminary Decision petition. For a full description of the Volumes I–V Supplemental Questionnaires: Memorandum). Thermal Paper from Germany, Japan, Korea, and 4 See Antidumping Duties; Countervailing Duties; 7 See, e.g., Notice of Preliminary Determination of Spain,’’ dated October 16, 2020 at section Final Rule, 62 FR 27296, 27323 (May 19, 1997) Sales at Less Than Fair Value: Sodium Nitrite from ‘‘Petitioners’ Responses to Supplemental Questions (Preamble). the Federal Republic of Germany, 73 FR 21909, Regarding Volume V’’; and Checklist, ‘‘Enforcement 5 See Initiation Notice, 85 FR 69580, 69581. 21912 (April 23, 2008), unchanged in Notice of and Compliance Office of AD/CVD Operations 6 See Memorandum, ‘‘Thermal Paper from Final Determination of Sales at Less Than Fair Antidumping Duty Investigation Initiation Germany, Japan, the Republic of Korea, and Spain: Value: Sodium Nitrite from the Federal Republic of Checklist: Thermal Paper from Spain,’’ dated Preliminary Scope Decision,’’ dated May 5, 2021. Germany, 73 FR 38986, 38987 (July 8, 2008), and October 27, 2020.

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estimated weighted-average dumping this investigation are encouraged to exports of the subject merchandise; and margin. These suspension of liquidation submit with each argument: (1) A (3) no compelling reasons for denial instructions will remain in effect until statement of the issue; (2) a brief exist, Commerce is postponing the final further notice. summary of the argument; and (3) a determination and extending the table of authorities. provisional measures from a four-month Disclosure Pursuant to 19 CFR 351.310(c), period to a period not greater than six Normally, Commerce discloses to interested parties who wish to request a months. Accordingly, Commerce will interested parties the calculations hearing, limited to issues raised in the make its final determination no later performed in connection with a case and rebuttal briefs, must submit a than 135 days after the date of preliminary determination within five written request to the Assistant publication of this preliminary days of any public announcement or, if Secretary for Enforcement and determination in the Federal Register. there is no public announcement, Compliance, U.S. Department of International Trade Commission within five days of the date of Commerce, within 30 days after the date Notification publication of the notice of preliminary of publication of this notice in the determination in the Federal Register, Federal Register. Requests for a hearing In accordance with section 733(f) of in accordance with 19 CFR 351.224(b). should contain: (1) The requesting the Act, Commerce will notify the However, because Commerce party’s name, address, and telephone International Trade Commission (ITC) of preliminarily applied AFA to the number; (2) the number of individuals its affirmative preliminary mandatory respondent in this from the requesting party’s firm that determination. If the final determination investigation, Torraspapel, in will attend the hearing, including is affirmative, the ITC will determine, accordance with section 776 of the Act, whether any individual is a foreign before the later of 120 days after the date and the AFA dumping margin is based national; and (3) a list of the issues the of this preliminary determination or 45 solely on the petition, there are no party intends to discuss at the hearing. days after Commerce’s final calculations to disclose. If a request for a hearing is made, determination, whether subject imports are materially injuring, or threaten Verification Commerce intends to hold the hearing at a time and date to be determined. material injury to, the U.S. industry. Because the mandatory respondent in Parties should confirm by telephone the Notification to Interested Parties this investigation did not act to the best date, and time of the hearing two days of its ability to provide information before the scheduled hearing date. This determination is issued and requested by Commerce, and Commerce published in accordance with sections preliminarily determined that the Postponement of Final Determination 733(f) and 777(i)(1) of the Act and 19 mandatory respondent is uncooperative, and Extension of Provisional Measures CFR 351.205(c). we will not conduct verification. Section 735(a)(2) of the Act provides Dated: May 5, 2021. Public Comment that a final determination may be Christian Marsh, postponed until not later than 135 days Case briefs or other written comments Acting Assistant Secretary for Enforcement after the date of the publication of the and Compliance. on non-scope issues may be submitted preliminary determination in the Appendix I—Scope of the Investigation to the Assistant Secretary for Federal Register if, in the event of an Enforcement and Compliance no later affirmative preliminary determination, a The scope of this investigation covers than 21 days after the date of request for such postponement is made thermal paper in the form of ‘‘jumbo rolls’’ publication of the preliminary and certain ‘‘converted rolls.’’ The scope 8 by exporters who account for a determination in the Federal Register. significant proportion of exports of the covers jumbo rolls and converted rolls of thermal paper with or without a base coat Rebuttal briefs on non-scope issues, subject merchandise, or in the event of limited to issues raised in case briefs on (typically made of clay, latex, and/or plastic a negative preliminary determination, a pigments, and/or like materials) on one or non-scope issues, may be submitted no request for such postponement is made later than seven days after the deadline both sides; with thermal active coating(s) by the petitioner. Section 351.210(e)(2) (typically made of sensitizer, dye, and co- for case briefs.9 The deadlines for of Commerce’s regulations requires that reactant, and/or like materials) on one or submitting case and rebuttal briefs on a request by exporters for postponement both sides; with or without a top coat scope issues are in the Preliminary of the final determination be (typically made of pigments, polyvinyl Scope Decision Memorandum. Note that accompanied by a request for extension alcohol, and/or like materials), and without an adhesive backing. Jumbo rolls are defined Commerce has temporarily modified of provisional measures from a four- certain of its requirements for serving as rolls with an actual width of 4.5 inches or month period to a period not more than more, an actual weight of 65 pounds or more, documents containing business six months in duration. proprietary information, until further and an actual diameter of 20 inches or more On April 27, 2021, pursuant to 19 (jumbo rolls). All jumbo rolls are included in notice.10 Pursuant to 19 CFR CFR 351.210(e), Torraspapel requested the scope regardless of the basis weight of the 351.309(c)(2) and (d)(2), parties who that Commerce postpone the final paper. Also included in the scope are submit case briefs or rebuttal briefs in determination and that provisional ‘‘converted rolls’’ with an actual width of less than 4.5 inches, and with an actual basis 8 measures be extended not more than six See 19 CFR 351.309(c)(1)(i); see also 19 CFR 11 weight of 70 grams per square meter (gsm) or 351.303 (for general filing requirements). Commerce months. In accordance with section less. has exercised its discretion under 19 CFR 735(a)(2)(A) of the Act and 19 CFR The scope of this investigation covers 351.309(c)(1)(i) to alter the time limit for 351.210(b)(2)(ii), because: (1) The thermal paper that is converted into rolls submission of case briefs. preliminary determination is with an actual width of less than 4.5 inches 9 See 19 CFR 351.309; see also 19 CFR 351.303 and with an actual basis weight of 70 gsm or (for general filing requirements). affirmative; (2) the requesting exporter less in third countries from jumbo rolls 10 See Temporary Rule Modifying AD/CVD accounts for a significant proportion of Service Requirements Due to COVID–19, 85 FR produced in the subject countries. 17006 (March 26, 2020); and Temporary Rule 11 See Torraspapel’s Letter, ‘‘Thermal Paper from The merchandise subject to this Modifying AD/CVD Service Requirements Due to Spain; AD Investigation; Request for Postponement investigation may be classified in the COVID–19; Extension of Effective Period, 85 FR of Final Determination and Extension of Provisional Harmonized Tariff Schedule of the United 41363 (July 10, 2020). Measures Period,’’ dated April 27, 2021. States (HTSUS) under subheadings

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4811.90.8030 and 4811.90.9030. Although Africa, telephone: 202–250–9798 (Ms. Executive Order 13675, as amended, HTSUS subheadings are provided for Bubna) and 202–766–8044 (Mr. provides that the Advisory Council shall convenience and customs purposes, the Cavallo), email: [email protected], consist of not more than 26 private written description of the scope of this [email protected], and sector corporate members, including investigation is dispositive. [email protected]. small businesses and representatives Appendix II—List of Topics Discussed SUPPLEMENTARY INFORMATION: The from infrastructure, agriculture, in the Preliminary Decision President’s Advisory Council on Doing consumer goods, banking, services, and Memorandum Business in Africa (Advisory Council) other industries. The Secretary of Commerce intends to make I. Summary was established pursuant to Executive II. Background Order No. 13675 dated August 5, 2014, appointments under this notice up to III. Period of Investigation and continued by Executive Order the current number of Advisory Council IV. Scope Comments 13889 until September 30, 2021. The members, consistent with the Executive V. Scope of the Investigation Advisory Council was established in Order and the Advisory Council charter. VI. Application of Facts Available, Use of accordance with the provisions of the The Advisory Council shall be Adverse Inferences, and Calculation of Federal Advisory Committee Act broadly representative of the key All-Others Rate (FACA), as amended, 5 U.S.C. App., to industries with business interests in the VII. Recommendation advise the President through the functions of the Advisory Council as set [FR Doc. 2021–09967 Filed 5–11–21; 8:45 am] Secretary of Commerce (Secretary) on forth above. Each Advisory Council BILLING CODE 3510–DS–P strengthening commercial engagement member shall serve as the representative between the United States and Africa. of a U.S. company engaged in activities The Department of Commerce, involving trade, investment, DEPARTMENT OF COMMERCE International Trade Administration, development or finance with African Office of Africa, is accepting markets. The Department particularly International Trade Administration applications for Advisory Council seeks applicants who are active members. The Advisory Council shall executives (Chief Executive Officer, President’s Advisory Council on Doing Executive Chairman, President or Business in Africa provide information, analysis, and recommendations to the President that comparable level of responsibility); AGENCY: U.S. Department of Commerce, address the following, in addition to however, for very large companies, a International Trade Administration. other topics deemed relevant by the person having substantial responsibility ACTION: Notice of an opportunity to President, the Secretary, or the Advisory for the company’s commercial activities apply for membership on the President’s Council: in Africa may be considered. For eligibility purposes, a ‘‘U.S. Advisory Council on Doing Business in (i) Creating jobs in the United States company’’ is a for-profit firm Africa. and Africa through trade and investment; incorporated in the United States or SUMMARY: The Department of Commerce (ii) developing strategies by which the with its principal place of business in is currently seeking applications for U.S. private sector can identify and take the United States that is (a) majority membership on the 2021–2023 term of advantage of trade and investment controlled (more than 50 percent the President’s Advisory Council opportunities in Africa; ownership interest and/or voting stock) (Advisory Council) on Doing Business (iii) building lasting commercial by U.S. citizens or by another U.S. in Africa. The purpose of the Advisory partnerships between the U.S. and entity or (b) majority controlled (more Council is to advise the President African private sectors; than 50 percent ownership interest and/ through the Secretary of Commerce on (iv) facilitating U.S. business or voting stock) directly or indirectly by strengthening commercial engagement participation in Africa’s infrastructure a foreign parent company. Members are between the United States and Africa. development; not required to be a U.S. citizen; This term, the Secretary is particularly (v) contributing to the growth and however, members may not be interested in advice on advancing improvement of Africa’s agricultural registered as a foreign agent under the President Biden’s strategy for Africa. sector by encouraging partnerships Foreign Agents Registration Act. Additionally, no member shall represent DATES: All applications for immediate between U.S. and African companies to a company that is majority owned or consideration for appointment must be bring innovative agricultural controlled by a foreign government received by the Office of Africa by 5:00 technologies to Africa; (vi) making available to the U.S. entity or entities. p.m. Eastern Daylight Time (EDT) on Members of the Advisory Council will June 25, 2021. After that date, the private sector an accurate understanding of the opportunities presented for be selected, in accordance with International Trade Administration applicable Department of Commerce (ITA) will continue to accept increasing trade with and investment in Africa; guidelines, based on their ability to applications under this notice for a carry out the objectives of the Advisory period of up to two years from the (vii) developing and strengthening partnerships and other mechanisms to Council as set forth above. Members deadline to fill any vacancies that may shall be selected in a manner that arise. increase U.S. public and private sector financing of trade with and investment ensures that the Advisory Council is ADDRESSES: Please submit applications in Africa; balanced in terms of points of view, by email to [email protected], attention: (viii) analyzing the effect of policies industry subsector, activities in and Ashley Bubna and Giancarlo Cavallo, in the United States and Africa on U.S. with African markets, range of products Designated Federal Officers, President’s trade and investment interests in Africa; and services, demographics, geography, Advisory Council on Doing Business in (ix) identifying other means to expand and company size. Additional factors Africa, Office of Africa. commercial ties between the United which will be considered in the FOR FURTHER INFORMATION CONTACT: States and Africa; and selection of Advisory Council members Ashley Bubna and Giancarlo Cavallo, (x) building the capacity of Africa’s include candidates’ proven leadership Designated Federal Officers, President’s young entrepreneurs to develop trade and experience in the trade, investment, Advisory Council on Doing Business in and investment ties with U.S. partners. financing, development, or other

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commercial activities between the appropriate, signifying compliance with on November 3, 2020.1 On February 25, United States and Africa. Priority may the criteria set forth above. 2021, Commerce postponed the be given to active executives (Chief 6. The company’s size, product or deadline for the preliminary Executive Officer, Executive Chairman, service line, and major markets in determination in this investigation; the President or comparable level of which the company operates. revised deadline is now May 5, 2021.2 responsibility). Appointments to the 7. A profile of the company’s trade, For a complete description of the events Advisory Council shall be made without investment, development, finance, that followed the initiation of this regard to political affiliation. partnership, or other commercial investigation, see the Preliminary The Secretary appoints the members activities in or with African markets. Decision Memorandum.3 A list of topics of the Advisory Council in consultation 8. Brief statement describing how the discussed in the Preliminary Decision with the Trade Promotion Coordinating applicant will contribute to the work of Memorandum is in Appendix II to this Committee (TPCC), a Federal the Advisory Council based on his or notice. The Preliminary Decision interagency group led by the Secretary her unique experience and perspective Memorandum is a public document and and tasked with coordinating export (not to exceed 100 words). is on file electronically via Enforcement promotion and export financing and Compliance’s Antidumping and activities of the U.S. Government and Frederique Stewart, Countervailing Duty Centralized development of a government-wide Director, Office of Africa. Electronic Service System (ACCESS). strategic plan to carry out such [FR Doc. 2021–09979 Filed 5–11–21; 8:45 am] ACCESS is available to registered users activities. Members shall serve a term of BILLING CODE 3510–DR–P at https://access.trade.gov. In addition, a two years, at the pleasure of the complete version of the Preliminary Secretary. Decision Memorandum can be accessed Members shall serve in a DEPARTMENT OF COMMERCE directly at http://enforcement.trade.gov/ representative capacity, representing the frn/. views and interests of their particular International Trade Administration industry sector. Advisory Council Scope of the Investigation members are not special government [A–580–911] The products covered by this employees, and will receive no Thermal Paper From the Republic of investigation are thermal paper from compensation for their participation in Korea. For a complete description of the Advisory Council activities. Members Korea: Preliminary Affirmative Determination of Sales at Less Than scope of this investigation, see participating in Advisory Council Appendix I. meetings and events will be responsible Fair Value, Preliminary Affirmative for their travel, living and other Determination of Critical Scope Comments personal expenses. Meetings will be Circumstances, Postponement of Final held regularly and, to the extent Determination, and Extension of In accordance with the Preamble to practical, not less than twice annually, Provisional Measures Commerce’s regulations,4 the Initiation in Washington, DC, or other locations as Notice set aside a period of time for AGENCY: feasible. Teleconference meetings may Enforcement and Compliance, parties to raise issues regarding product also be held as needed. International Trade Administration, coverage (i.e., scope).5 Certain interested Department of Commerce. To be considered for membership, parties commented on the scope of the submit the following information by SUMMARY: The Department of Commerce investigation as it appeared in the 5:00 p.m. EDT on June 25, 2021 to the (Commerce) preliminarily determines Initiation Notice. For a summary of the email address listed in the ADDRESSES that thermal paper from the Republic of product coverage comments and section: Korea (Korea) is being, or is likely to be, rebuttals submitted on the record of this 1. Name and title of the individual sold in the United States at less than fair investigation, and accompanying requesting consideration. value (LTFV). The period of discussion and analysis of all comments 2. A sponsor letter from the applicant investigation is October 1, 2019, through timely received, see the Preliminary 6 on his or her company letterhead September 30, 2020. Interested parties Scope Decision Memorandum. containing a brief statement of why the are invited to comment on this Commerce is not preliminarily applicant should be considered for preliminary determination. modifying the scope language as it membership on the Advisory Council. DATES: Applicable May 12, 2021. This sponsor letter should also address 1 See Thermal Paper from Germany, Japan, the FOR FURTHER INFORMATION CONTACT: Republic of Korea, and Spain: Initiation of Less- the applicant’s experience and Kristen Ju or Aleksandras Nakutis, AD/ Than-Fair-Value Investigations, 85 FR 69580 leadership related to trade, investment, CVD Operations, Office IV, Enforcement (November 3, 2020) (Initiation Notice). financing, development, or other and Compliance, International Trade 2 See Thermal Paper from Germany, Japan, the commercial activities between the Administration, U.S. Department of Republic of Korea, and Spain: Postponement of United States and Africa. Preliminary Determinations in the Less-Than-Fair- Commerce, 1401 Constitution Avenue Value Investigations, 86 FR 11502 (February 25, 3. The applicant’s personal resume NW, Washington, DC 20230; telephone: 2021). and short bio (less than 300 words). (202) 482–3699 or (202) 482–3147, 3 See Memorandum, ‘‘Decision Memorandum for 4. An affirmative statement that the respectively. the Preliminary Determination in the Less-Than- applicant meets all eligibility criteria, Fair-Value Investigation of Thermal Paper from the SUPPLEMENTARY INFORMATION: Republic of Korea,’’ dated concurrently with, and including an affirmative statement that hereby adopted by, this notice (Preliminary the applicant is not required to register Background Decision Memorandum). as a foreign agent under the Foreign 4 See Antidumping Duties; Countervailing Duties, Agents Registration Act of 1938, as This preliminary determination is Final Rule, 62 FR 27296, 27323 (May 19, 1997) amended. made in accordance with section 733(b) (Preamble). of the Tariff Act of 1930, as amended 5 See Initiation Notice, 85 FR at 69581. 5. Information regarding the 6 See Memorandum, ‘‘Thermal Paper from ownership and control of the company, (the Act). Commerce published the Germany, Japan, the Republic of Korea, and Spain: including the stock holdings as notice of initiation of this investigation Preliminary Scope Decision,’’ dated May 5, 2021.

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appeared in the Initiation Notice. See Estimated These suspension of liquidation the scope in Appendix I to this notice. weighted- instructions will remain in effect until Exporter/producer average further notice. Methodology dumping margin Disclosure Commerce is conducting this (percent) investigation in accordance with section Commerce intends to disclose its 731 of the Act. Commerce calculated Hansol Paper Company ...... 6.19 preliminary calculations and related All-Others ...... 6.19 export prices in accordance with section analysis to interested parties within five 772(a) of the Act and constructed export days of any public announcement of the prices in accordance with section 772(b) Suspension of Liquidation preliminary determination or, if there is of the Act. Commerce calculated normal no public announcement, within five In accordance with section 733(d)(2) days of the date of publication of this value in accordance with section 773 of of the Act, Commerce will direct U.S. notice in the Federal Register in the Act. For a full description of the Customs and Border Protection (CBP) to accordance with 19 CFR 351.224(b). methodology underlying the suspend liquidation of entries of subject preliminary determination, see the merchandise described in Appendix I Verification Preliminary Decision Memorandum. on and after the date identified below. As provided in section 782(i)(1) of the Further, pursuant to section 733(d)(1)(B) Preliminary Affirmative Determination Act, Commerce intends to verify the of the Act and 19 CFR 351.205(d), of Critical Circumstances information relied upon in making its Commerce will instruct CBP to require final determination. Normally, In accordance with section 733(e) of a cash deposit equal to the estimated Commerce verifies information using the Act and 19 CFR 351.206, Commerce weighted-average dumping margin or standard procedures, including an on- preliminarily finds that critical the estimated all-others rate, as follows: site examination of original accounting, circumstances exist for Hansol Paper (1) The cash deposit rate for the financial, and sales documentation. Company (Hansol Paper) and all other respondent listed above will be equal to However, due to current travel the company-specific estimated producers and exporters in Korea. For a restrictions in response to the global weighted-average dumping margin full description of the methodology and COVID–19 pandemic, Commerce is determined in this preliminary results of Commerce’s critical unable to conduct on-site verification in determination; (2) if the exporter is not this investigation. Accordingly, we circumstances analysis, see the a respondent identified above, but the Preliminary Decision Memorandum. intend to verify the information relied producer is, then the cash deposit rate upon in making the final determination All-Others Rate will be equal to the company-specific through alternative means in lieu of an estimated weighted-average dumping on-site verification. Sections 733(d)(1)(ii) and 735(c)(5)(A) margin established for that producer of of the Act provide that, in the the subject merchandise; and (3) the Public Comment preliminary determination, Commerce cash deposit rate for all other producers Case briefs or other written comments shall determine an estimated all-others and exporters will be equal to the all- on non-scope issues may be submitted rate for all exporters and producers not others estimated weighted-average dumping margin. to the Assistant Secretary for individually examined. This rate shall Enforcement and Compliance. A be equal to the weighted average of the Section 733(e)(2) of the Act provides timeline for the submission of case estimated weighted-average dumping that, given an affirmative determination briefs and written comments on non- margins established for exporters and of critical circumstances, any scope issues will be provided to producers individually investigated, suspension of liquidation shall apply to interested parties later. Rebuttal briefs, excluding any zero and de minimis unliquidated entries of subject limited to issues raised in case briefs on dumping margins, and any dumping merchandise entered, or withdrawn non-scope issues, may be submitted no margins determined entirely under from warehouse, for consumption on or later than seven days after the deadline section 776 of the Act. after the later of: (a) The date which is date for case briefs.7 The deadlines for 90 days before the date on which the Commerce calculated an individual submitting case and rebuttal briefs on suspension of liquidation was first estimated weighted-average dumping scope issues are identified in the ordered; or (b) the date on which the Preliminary Scope Decision margin for Hansol Paper, the only notice of initiation of the investigation individually examined exporter/ Memorandum. Note that Commerce has was published. As noted above, temporarily modified certain of its producer in this investigation. Because Commerce preliminarily finds that the only individually calculated requirements for serving documents critical circumstances exist for imports containing business proprietary dumping margin is not zero, de of subject merchandise produced and information, until further notice.8 minimis, or based entirely on facts exported by Hansol Paper and all other Pursuant to 19 CFR 351.309(c)(2) and otherwise available, we assigned the exporters and producers in Korea. In (d)(2), parties who submit case briefs or estimated weighted-average dumping accordance with section 733(e)(2)(A) of rebuttal briefs in this investigation are margin that we calculated for Hansol the Act, the suspension of liquidation encouraged to submit with each Paper to all other producers and shall apply to unliquidated entries of argument: (1) A statement of the issue; exporters in Korea, pursuant to section shipments of subject merchandise from 735(c)(5)(A) of the Act. Hansol Paper and all other exporters 7 See 19 CFR 351.309; see also 19 CFR 351.303 and producers in Korea that were Preliminary Determination (for general filing requirements). entered, or withdrawn from warehouse, 8 See Temporary Rule Modifying AD/CVD Service Commerce preliminarily determines for consumption on or after the date Requirements Due to COVID–19, 85 FR 17006 which is 90 days before the date of (March 26, 2020); and Temporary Rule Modifying that the following estimated weighted- AD/CVD Service Requirements Due to COVID–19; average dumping margins exist: publication of this notice in the Federal Extension of Effective Period, 85 FR 41363 (July 10, Register. 2020).

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(2) a brief summary of the argument; determination and extending the written description of the scope of this and (3) a table of authorities. provisional measures from a four-month investigation is dispositive. Pursuant to 19 CFR 351.310(c), period to a period not greater than six Appendix II—List of Topics Discussed interested parties who wish to request a months. Accordingly, Commerce will in the Preliminary Decision hearing, limited to issues raised in the make its final determination no later Memorandum case and rebuttal briefs, must submit a than 135 days after the date of written request to the Assistant publication of this preliminary I. Summary Secretary for Enforcement and determination in the Federal Register. II. Background Compliance, U.S. Department of III. Period of Investigation Commerce, within 30 days after the date International Trade Commission IV. Scope Comments Notification V. Scope of the Investigation of publication of this notice in the VI. Critical Circumstances Federal Register. Requests for a hearing In accordance with section 733(f) of VII. Discussion of the Methodology should contain: (1) The requesting the Act, Commerce will notify the VIII. Date of Sale party’s name, address, and telephone International Trade Commission (ITC) of IX. Product Comparisons number; (2) the number of individuals its affirmative preliminary X. Export Price and Constructed Export Price from the requesting party’s firm that determination. If the final determination XI. Normal Value will attend the hearing, including is affirmative, the ITC will determine, XII. Currency Conversion whether any participant is a foreign before the later of 120 days after the date XIII. Recommendation national; and (3) a list of the issues the of this preliminary determination or 45 [FR Doc. 2021–09966 Filed 5–11–21; 8:45 am] party intends to discuss at the hearing. days after Commerce’s final BILLING CODE 3510–DS–P If a request for a hearing is made, determination whether subject imports Commerce intends to hold the hearing are materially injuring, or threaten at a time and date to be determined. material injury to, the U.S. industry. DEPARTMENT OF COMMERCE Parties should confirm by telephone the date and time of the hearing two days Notification to Interested Parties International Trade Administration before the scheduled hearing date. This determination is issued and [A–570–920] published in accordance with sections Postponement of Final Determination 733(f) and 777(i)(1) of the Act and 19 Lightweight Thermal Paper From the and Extension of Provisional Measures CFR 351.205(c). People’s Republic of China: Section 735(a)(2) of the Act provides Dated: May 5, 2021. Rescission of Antidumping Duty that a final determination may be Administrative Review; 2019–2020 postponed until not later than 135 days Christian Marsh, after the date of the publication of the Acting Assistant Secretary for Enforcement AGENCY: Enforcement and Compliance, preliminary determination in the and Compliance. International Trade Administration, Federal Register if, in the event of an Appendix I—Scope of the Investigation Department of Commerce. affirmative preliminary determination, a DATES: Applicable May 12, 2021. The scope of this investigation covers request for such postponement is made thermal paper in the form of ‘‘jumbo rolls’’ SUMMARY: The Department of Commerce by exporters who account for a and certain ‘‘converted rolls.’’ The scope (Commerce) is rescinding the 2019– significant proportion of exports of the covers jumbo rolls and converted rolls of 2020 antidumping duty (AD) subject merchandise, or in the event of thermal paper with or without a base coat administrative review of lightweight a negative preliminary determination, a (typically made of clay, latex, and/or plastic thermal paper (LWTP) from the People’s request for such postponement is made pigments, and/or like materials) on one or Republic of China (China) based on a by the petitioner. Section 351.210(e)(2) both sides; with thermal active coating(s) (typically made of sensitizer, dye, and co- timely request for withdrawal. The of Commerce’s regulations requires that period of review (POR) is November 1, a request by exporters for postponement reactant, and/or like materials) on one or both sides; with or without a top coat 2019, through October 31, 2020. of the final determination be (typically made of pigments, polyvinyl FOR FURTHER INFORMATION CONTACT: Alex accompanied by a request for extension alcohol, and/or like materials), and without Cipolla, AD/CVD Operations, Office III, of provisional measures from a four- an adhesive backing. Jumbo rolls are defined Enforcement and Compliance, month period to a period not more than as rolls with an actual width of 4.5 inches or International Trade Administration, six months in duration. more, an actual weight of 65 pounds or more, On April 19, 2021, pursuant to 19 and an actual diameter of 20 inches or more U.S. Department of Commerce, 1401 CFR 351.210(e), Hansol Paper requested (jumbo rolls). All jumbo rolls are included in Constitution Avenue NW, Washington, that Commerce postpone the final the scope regardless of the basis weight of the DC 20230; telephone: (202) 482–4956. determination and that provisional paper. Also included in the scope are SUPPLEMENTARY INFORMATION: ‘‘converted rolls’’ with an actual width of less measures be extended not more than six Background months.9 In accordance with section than 4.5 inches, and with an actual basis weight of 70 grams per square meter (gsm) or On November 3, 2020, Commerce 735(a)(2)(A) of the Act and 19 CFR less. 351.210(b)(2)(ii), because: (1) The published in the Federal Register a The scope of this investigation covers notice of opportunity to request an preliminary determination is thermal paper that is converted into rolls affirmative; (2) the requesting exporter with an actual width of less than 4.5 inches administrative review of the AD order 1 accounts for a significant proportion of and with an actual basis weight of 70 gsm or on LWTP from China. Commerce exports of the subject merchandise; and less in third countries from jumbo rolls received a timely-filed request from (3) no compelling reasons for denial produced in the subject countries. Appvion, Inc. (Appvion), a domestic exist, Commerce is postponing the final The merchandise subject to this interested party and the petitioner in the investigation may be classified in the underlying investigation, for an Harmonized Tariff Schedule of the United 9 See Hansol Paper’s Letter, ‘‘Thermal Paper Products from the Republic of Korea: Request for States (HTSUS) under subheadings 1 See Antidumping or Countervailing Duty Order, Postponement of Final Determination and 4811.90.8030 and 4811.90.9030. Although Finding, or Suspended Investigation; Opportunity Extension of Provisional Measures Period,’’ dated HTSUS subheadings are provided for to Request Administrative Review, 85 FR 69586 April 19, 2021. convenience and customs purposes, the (November 3, 2020).

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administrative review of exports of of antidumping and/or countervailing subsidies on articles of cheese subject to subject merchandise to the United duties prior to liquidation of the an in-quota rate of duty covering the States during the POR with respect to 20 relevant entries during this review period July 1, 2020, through September companies, in accordance with section period. Failure to comply with this 30, 2020.1 In the Third Quarter 2020 751(a) of the Tariff Act of 1930, as requirement could result in the Update, we requested that any party amended (the Act), and 19 CFR presumption that reimbursement of the that has information on foreign 351.213(b).2 On January 6, 2021, antidumping and/or countervailing government subsidy programs that pursuant to this request, and in duties occurred and the subsequent benefit articles of cheese subject to an accordance with 19 CFR assessment of double antidumping in-quote rate of duty submit such 351.221(c)(1)(i), Commerce published a duties. information to Commerce.2 We received notice initiating an administrative Notification Regarding Administrative no comments, information, or requests review of the AD order on LWTP from Protective Order for consultation from any party. China.3 On March 26, 2021, Appvion withdrew its request for an This notice also serves as a reminder Pursuant to section 702(h) of the Act, administrative review with respect to all to all parties subject to administrative we hereby provide Commerce’s update companies for which it requested a protective order (APO) of their of subsidies on articles of cheese that review.4 responsibility concerning the were imported during the period disposition of proprietary information September 1, 2020, through December Rescission of Review disclosed under APO in accordance 31, 2020. The appendix to this notice Pursuant to 19 CFR 351.213(d)(1), with 19 CFR 351.305(a)(3). Timely lists the country, the subsidy program or Commerce will rescind an written notification of the return/ programs, and the gross and net administrative review, in whole or in destruction of APO materials or amounts of each subsidy for which part, if the party or parties that conversion to judicial protective order is information is currently available. requested a review withdraws the hereby requested. Failure to comply request within 90 days of the with the regulations and terms of an Commerce will incorporate additional publication date of the notice of APO is a violation which is subject to programs which are found to constitute initiation of the requested review. sanction. subsidies, and additional information on the subsidy programs listed, as the Appvion timely submitted a request to Notification to Interested Parties withdraw its request for an information is developed. Commerce administrative review for all companies This notice is issued and published in encourages any person having for which an administrative review was accordance with sections 751(a) and information on foreign government initiated. No other party requested an 777(i)(1) of the Act, and 19 CFR subsidy programs which benefit articles administrative review of the order. 351.213(d)(4). of cheese subject to an in-quota rate of Therefore, in accordance with 19 CFR Dated: May 6, 2021. duty to submit such information in 351.213(d)(1), we are rescinding this James Maeder, writing through the Federal review, in its entirety. Deputy Assistant Secretary for Antidumping eRulemaking Portal at https:// www.regulations.gov, Docket No. ITA– Assessment and Countervailing Duty Operations. [FR Doc. 2021–10034 Filed 5–11–21; 8:45 am] 2020–0005, ‘‘Quarterly Update to Commerce will instruct U.S. Customs BILLING CODE 3510–DS–P Cheese Subject to an In-Quota Rate of and Border Protection (CBP) to assess Duty.’’ The materials in the docket will antidumping duties on all appropriate not be edited to remove identifying or entries of LWTP from China. DEPARTMENT OF COMMERCE contact information, and Commerce Antidumping duties shall be assessed at cautions against including any rates equal to the cash deposit of International Trade Administration information in an electronic submission estimated antidumping duties required that the submitter does not want Quarterly Update to Annual Listing of at the time of entry, or withdrawal from publicly disclosed. Attachments to Foreign Government Subsidies on warehouse, for consumption in electronic comments will be accepted in Articles of Cheese Subject to an In- accordance with 19 CFR Microsoft Word, Excel, or Adobe PDF Quota Rate of Duty 351.212(c)(1)(i). Commerce intends to formats only. All comments should be issue appropriate assessment AGENCY: Enforcement and Compliance, addressed to the Assistant Secretary for instructions to CBP 35 days after the International Trade Administration, Enforcement and Compliance, U.S. date of publication of this notice in the Department of Commerce. Department of Commerce, 1401 Federal Register. DATES: Applicable May 12, 2021. Constitution Ave. NW, Washington, DC Notification to Importers FOR FURTHER INFORMATION CONTACT: John 20230. This notice serves as the only Hoffner, AD/CVD Operations, Office III, This determination and notice are in reminder to importers whose entries Enforcement and Compliance, accordance with section 702(a) of the will be liquidated as a result of this International Trade Administration, Act. U.S. Department of Commerce, 1401 rescission notice, of their responsibility Dated: May 7, 2021. under 19 CFR 351.402(f)(2) to file a Constitution Ave. NW, Washington, DC James Maeder, certificate regarding the reimbursement 20230, telephone: (202) 482–3315. SUPPLEMENTARY INFORMATION: On Deputy Assistant Secretary for Antidumping and Countervailing Duty Operations. 2 See Appvion’s Letter, ‘‘Request for January 26, 2021, the Department of Administrative Review,’’ dated November 30, 2020. Commerce (Commerce), pursuant to 1 3 See Initiation of Antidumping and section 702(h) of the Trade Agreements See Quarterly Update to Annual Listing of Countervailing Duty Administrative Reviews, 86 FR Foreign Government Subsidies on Articles of Cheese 511 (January 6, 2021). Act of 1979 (as amended) (the Act), Subject to an In-Quota Rate of Duty, 86 FR 7062 4 See Appvion’s Letter, ‘‘Withdrawal of Request published the quarterly update to the (January 26, 2021) (Third Quarter 2020 Update). for Administrative Review,’’ dated March 26, 2021. annual listing of foreign government 2 Id.

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Appendix

SUBSIDY PROGRAMS ON CHEESE SUBJECT TO AN IN-QUOTA RATE OF DUTY

Gross 3 Net 4 Country Program(s) subsidy subsidy ($/lb) ($/lb)

27 European Union Member States 5 ...... European Union Restitution Payments ...... $0.00 $0.00 Canada ...... Export Assistance on Certain Types of Cheese ...... 0.46 0.46 Norway ...... Indirect (Milk) Subsidy ...... 0.00 0.00 Consumer Subsidy ...... 0.00 0.00

Total ...... 0.00 0.00 Switzerland ...... Deficiency Payments ...... 0.00 0.00

[FR Doc. 2021–10036 Filed 5–11–21; 8:45 am] (the Act). Commerce published the product coverage comments and BILLING CODE 3510–DS–P notice of initiation of this investigation rebuttal responses submitted on the on November 3, 2020.1 On February 25, record for this investigation, and 2021, Commerce postponed the accompanying discussion and analysis DEPARTMENT OF COMMERCE preliminary determination of this of all comments timely received, see the investigation; the revised deadline is Preliminary Scope Decision International Trade Administration now May 5, 2021.2 For a complete Memorandum.6 Commerce is not [A–588–880] description of the events that followed preliminarily modifying the scope the initiation of this investigation, see language as it appeared in the Initiation Thermal Paper From Japan: the Preliminary Decision Notice. See the scope in Appendix I to Preliminary Affirmative Determination Memorandum.3 A list of topics this notice. of Sales at Less Than Fair Value, discussed in the Preliminary Decision Methodology Postponement of Final Determination, Memorandum is included in Appendix and Extension of Provisional Measures II to this notice. The Preliminary Commerce is conducting this Decision Memorandum is a public investigation in accordance with section AGENCY: Enforcement and Compliance, document and is on file electronically International Trade Administration, 731 of the Act. Commerce has via Enforcement and Compliance’s Department of Commerce. calculated export prices in accordance Antidumping and Countervailing Duty with section 772(a) of the Act. SUMMARY: The Department of Commerce Centralized Electronic Service System Constructed export prices have been (Commerce) preliminarily determines (ACCESS). ACCESS is available to calculated in accordance with section that thermal paper from Japan is being, registered users at https:// 772(b) of the Act. Normal value is or is likely to be, sold in the United access.trade.gov. In addition, a complete calculated in accordance with section States at less than fair value (LTFV). The version of the Preliminary Decision 773 of the Act. In addition, Commerce period of investigation is October 1, Memorandum can be accessed directly has relied on partial facts available 2019, through September 30, 2020. at http://enforcement.trade.gov/frn/. under section 776(a)(1) of the Act. For Interested parties are invited to Scope of the Investigation a full description of the methodology comment on this preliminary underlying the preliminary determination. The products covered by this determination, see the Preliminary DATES: Applicable May 12, 2021. investigation are thermal paper from Decision Memorandum. FOR FURTHER INFORMATION CONTACT: Japan. For a complete description of the Alex All-Others Rate Wood, AD/CVD Operations, Office II, scope of this investigation, see Enforcement and Compliance, Appendix I. Sections 733(d)(1)(ii) and 735(c)(5)(A) International Trade Administration, Scope Comments of the Act provide that, in the U.S. Department of Commerce, 1401 preliminary determination, Commerce Constitution Avenue NW, Washington, In accordance with the preamble to shall determine an estimated all-others DC 20230; telephone: (202) 482–1959. Commerce’s regulations,4 the Initiation rate for all exporters and producers not SUPPLEMENTARY INFORMATION: Notice set aside a period of time for individually examined. This rate shall parties to raise issues regarding product be an amount equal to the weighted Background coverage (i.e., scope).5 Certain interested average of the estimated weighted- This preliminary determination is parties commented on the scope of the average dumping margins established made in accordance with section 733(b) investigation as it appeared in the for exporters and producers of the Tariff Act of 1930, as amended Initiation Notice. For a summary of the individually investigated, excluding any

3 Defined in 19 U.S.C. 1677(5). Than-Fair-Value Investigations, 85 FR 69580 adopted by, this notice (Preliminary Decision 4 Defined in 19 U.S.C. 1677(6). (November 3, 2020) (Initiation Notice). Memorandum). 5 The 27 member states of the European Union 2 See Thermal Paper from Germany, Japan, the 4 See Antidumping Duties; Countervailing Duties, are: Austria, Belgium, Bulgaria, Croatia, Cyprus, Republic of Korea, and Spain: Postponement of Final Rule, 62 FR 27296, 27323 (May 19, 1997). Czech Republic, Denmark, Estonia, Finland, France, Preliminary Determinations in the Less-Than-Fair- 5 See Initiation Notice. Germany, Greece, Hungary, Ireland, Italy, Latvia, Value Investigations, 86 FR 11502 (February 25, 6 See Memorandum, ‘‘Thermal Paper from Lithuania, Luxembourg, Malta, Netherlands, 2021). Germany, Japan, the Republic of Korea, and Spain: Poland, Portugal, Romania, Slovakia, Slovenia, 3 See Memorandum, ‘‘Decision Memorandum for Scope Comments Decision Memorandum for the Spain, and Sweden. the Preliminary Determination in the Less-Than- Preliminary Determinations,’’ dated concurrently 1 See Thermal Paper from Germany, Japan, the Fair-Value Investigation of Thermal Paper from with this notice (Preliminary Scope Decision Republic of Korea, and Spain: Initiation of Less- Japan,’’ dated concurrently with, and hereby Memorandum).

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zero and de minimis margins, and any estimated weighted-average dumping Pursuant to 19 CFR 351.310(c), margins determined entirely under margin. interested parties who wish to request a section 776 of the Act. hearing, limited to issues raised in the Disclosure Commerce calculated an individual case and rebuttal briefs, must submit a estimated weighted-average dumping Commerce intends to disclose its written request to the Assistant margin for Nippon Paper Industries Co., calculations and analysis performed to Secretary for Enforcement and Ltd. (NPI), the only individually interested parties in this preliminary Compliance, U.S. Department of examined exporter/producer in this determination within five days of any Commerce, within 30 days after the date investigation. Because the only public announcement or, if there is no of publication of this notice. Requests individually calculated dumping margin public announcement, within five days should contain the party’s name, is not zero, de minimis, or based of the date of publication of this notice address, and telephone number, the entirely on facts otherwise available, the in accordance with 19 CFR 351.224(b). number of participants, and a list of the estimated weighted-average dumping issues to be discussed. Oral margin calculated for NPI is the margin Verification presentations at the hearing will be assigned to all other producers and As provided in section 782(i)(1) of the limited to issues raised in the briefs. If exporters, pursuant to section Act, Commerce intends to verify the a request for a hearing is made, parties 735(c)(5)(A) of the Act. information relied upon in making its will be notified of the time and date for 10 Preliminary Determination final determination. Normally, the hearing. Commerce verifies information using Commerce preliminarily determines Postponement of Final Determination standard procedures, including an on- and Extension of Provisional Measures that the following estimated weighted- site examination of original accounting, average dumping margins exist: financial, and sales documentation. Section 735(a)(2) of the Act provides However, due to current travel Estimated that a final determination may be weighted- restrictions in response to the global postponed until not later than 135 days COVID–19 pandemic, Commerce is Exporter/producer average after the date of the publication of the dumping unable to conduct on-site verification in preliminary determination if, in the margin this investigation. Accordingly, we (percent) event of an affirmative preliminary intend to verify the information relied determination, a request for such Nippon Paper Industries Co., upon in making the final determination postponement is made by exporters who Ltd./Nippon Paper Papylia through alternative means in lieu of an account for a significant proportion of Co., Ltd 7 ...... 35.71 on-site verification. exports of the subject merchandise, or in All-Others ...... 35.71 Public Comment the event of a negative preliminary determination, a request for such Suspension of Liquidation Case briefs or other written comments postponement is made by the 11 In accordance with section 733(d)(2) on non-scope issues may be submitted petitioners. Pursuant to 19 CFR of the Act, Commerce will direct U.S. to the Assistant Secretary for 351.210(e)(2), Commerce requires that Customs and Border Protection (CBP) to Enforcement and Compliance. requests by respondents for suspend liquidation of entries of subject Interested parties will be notified of the postponement of a final AD merchandise, as described in Appendix timeline for the submission of case determination be accompanied by a I, entered, or withdrawn from briefs and written comments at a later request for extension of provisional warehouse, for consumption on or after date. Rebuttal briefs, limited to issues measures from a four-month period to a the date of publication of this notice in raised in case briefs on non-scope period not more than six months in the Federal Register. Further, pursuant issues, may be submitted no later than duration. to section 733(d)(1)(B) of the Act and 19 seven days after the deadline date for On April 19, 2021, NPI requested that 8 CFR 351.205(d), Commerce will instruct case briefs. The deadlines for Commerce postpone the final CBP to require a cash deposit equal to submitting case and rebuttal briefs on determination and that provisional the estimated weighted-average scope issues are identified in the measures be extended to a period not to dumping margin or the estimated all- Preliminary Scope Decision exceed six months.12 In accordance with others rate, as follows: (1) The cash Memorandum. Note that Commerce has section 735(a)(2)(A) of the Act and 19 deposit rate for the respondent listed temporarily modified certain of its CFR 351.210(b)(2)(ii), because: (1) The above will be equal to the company- requirements for serving documents preliminary determination is specific estimated weighted-average containing business proprietary affirmative; (2) the requesting exporter 9 dumping margin determined in this information, until further notice. accounts for a significant proportion of preliminary determination; (2) if the Pursuant to 19 CFR 351.309(c)(2) and exports of the subject merchandise; and exporter is not a respondent identified (d)(2), parties who submit case briefs or (3) no compelling reasons for denial above, but the producer is, then the cash rebuttal briefs in this investigation are exist, Commerce is postponing the final deposit rate will be equal to the encouraged to submit with each determination and extending the company-specific estimated weighted- argument: (1) A statement of the issue; provisional measures from a four-month average dumping margin established for (2) a brief summary of the argument; period to a period not greater than six that producer of the subject and (3) a table of authorities. months. Accordingly, Commerce will merchandise; and (3) the cash deposit make its final determination no later rate for all other producers and 8 See 19 CFR 351.309; see also 19 CFR 351.303 than 135 days after the date of exporters will be equal to the all-others (for general filing requirements). 9 See Temporary Rule Modifying AD/CVD Service Requirements Due to COVID–19, 85 FR 17006 10 See 19 CFR 351.310(d). 7 Commerce preliminarily determines that (March 26, 2020); and Temporary Rule Modifying 11 The petitioners are Appvion Operations, Inc., Nippon Paper Industries Co, Ltd. and Nippon Paper AD/CVD Service Requirements Due to COVID–19; and Domtar Corporation. Papylia Co., Ltd. are a single entity. See Preliminary Extension of Effective Period, 85 FR 41363 (July 10, 12 See NPI’s Letter, ‘‘NPI’s Request to Postpone Decision Memorandum. 2020). the Final Determination,’’ dated April 19, 2021.

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publication of this preliminary ‘‘converted rolls’’ with an actual width of less DEPARTMENT OF COMMERCE determination. than 4.5 inches, and with an actual basis weight of 70 grams per square meter (gsm) or National Oceanic and Atmospheric International Trade Commission less. Administration Notification The scope of this investigation covers In accordance with section 733(f) of thermal paper that is converted into rolls [RTID 0648–XB081] the Act, Commerce will notify the with an actual width of less than 4.5 inches Marine Mammals and Endangered International Trade Commission (ITC) of and with an actual basis weight of 70 gsm or Species its preliminary determination. If the less in third countries from jumbo rolls final determination is affirmative, the produced in the subject countries. AGENCY: National Marine Fisheries ITC will determine before the later of The merchandise subject to this Service (NMFS), National Oceanic and 120 days after the date of this investigation may be classified in the Atmospheric Administration (NOAA), preliminary determination or 45 days Harmonized Tariff Schedule of the United Commerce. States (HTSUS) under subheadings after the final determination whether ACTION: Notice; issuance of permits and 4811.90.8030 and 4811.90.9030. Although these imports are materially injuring, or permit amendments. threaten material injury to, the U.S. HTSUS subheadings are provided for industry. convenience and customs purposes, the SUMMARY: Notice is hereby given that written description of the scope of this Notification to Interested Parties permits and permit amendments have investigation is dispositive. been issued to the following entities This determination is issued and Appendix II—List of Topics Discussed under the Marine Mammal Protection published in accordance with sections in the Preliminary Decision Act (MMPA) and the Endangered 733(f) and 777(i)(1) of the Act and 19 Species Act (ESA), as applicable. CFR 351.205(c). Memorandum ADDRESSES: The permits and related Dated: May 5, 2021. I. Summary documents are available for review Christian Marsh, II. Background upon written request via email to III. Period of Investigation Acting Assistant Secretary for Enforcement [email protected]. and Compliance. IV. Scope Comments V. Scope of the Investigation FOR FURTHER INFORMATION CONTACT: Appendix I—Scope of the Investigation VI. Discussion of the Methodology Amy Hapeman (Permit No. 25498), Shasta McClenahan, Ph.D. (Permit Nos. The scope of this investigation covers VII. Application of Facts Available thermal paper in the form of ‘‘jumbo rolls’’ VIII. Date of Sale 22306 and 23675), Jennifer Skidmore and certain ‘‘converted rolls.’’ The scope IX. Product Comparisons (Permit No. 23960 and 24395), Courtney covers jumbo rolls and converted rolls of X. Export Price and Constructed Export Price Smith, Ph.D. (Permit No. 24378), and thermal paper with or without a base coat XI. Normal Value Sara Young (Permit No. 23188–01); at (typically made of clay, latex, and/or plastic XII. Currency Conversion (301) 427–8401. pigments, and/or like materials) on one or XIII. Recommendation SUPPLEMENTARY INFORMATION: Notices both sides; with thermal active coating(s) (typically made of sensitizer, dye, and co- [FR Doc. 2021–09849 Filed 5–11–21; 8:45 am] were published in the Federal Register reactant, and/or like materials) on one or BILLING CODE 3510–DS–P on the dates listed below that requests both sides; with or without a top coat for a permit or permit amendment had (typically made of pigments, polyvinyl been submitted by the below-named alcohol, and/or like materials), and without applicants. To locate the Federal an adhesive backing. Jumbo rolls are defined Register notice that announced our as rolls with an actual width of 4.5 inches or receipt of the application and a more, an actual weight of 65 pounds or more, and an actual diameter of 20 inches or more complete description of the activities, go (jumbo rolls). All jumbo rolls are included in to www.federalregister.gov and search the scope regardless of the basis weight of the on the permit number provided in Table paper. Also included in the scope are 1 below.

TABLE 1—ISSUED PERMITS AND PERMIT AMENDMENTS

Previous Federal Register Permit No. RTID Applicant notice Issuance date

22306 ...... 0648–XA897 ..... NMFS Southwest Fisheries Science Center, 8901 La Jolla 86 FR 11729; February 26, April 21, 2021. Shores Drive, La Jolla, CA 92037 (Responsible Party: 2021. David W. Weller, Ph.D.). 23188–01 ... 0648–XA896 ..... Institute of Marine Sciences, University of California at 86 FR 11930; March 1, 2021 April 27, 2021. Santa Cruz, 130 McAllister Way, Santa Cruz, CA 95060 (Responsible Party: Daniel Costa, Ph.D.). 23675 ...... 0648–XA897 ..... Brianna Witteveen, Ph.D., University of Alaska Fairbanks, 86 FR 11729; February 26, April 13, 2021. 118 Trident Way, Kodiak, AK 99615. 2021. 23960 ...... 0648–XA912 ..... Minnesota Zoological Gardens, 13000 Zoo Boulevard, 86 FR 12918; March 5, 2021 April 30, 2021. Apple Valley, MN 55124 (Responsible Party: Tony Fish- er). 24378 ...... 0648–XA897 ..... University of Alaska Southeast—Sitka Campus, 1332 Sew- 86 FR 11729; February 26, April 29, 2021. ard Avenue Sitka, AK 99835 (Responsible Party: Janice 2021. Straley). 24395 ...... 648–XA893 ...... Lorrie Rea, Ph.D., University of Alaska Fairbanks, 1764 86 FR 11730; February 26, April 15, 2021. Tanana Loop ELIF Suite 240, Fairbanks, AK 99775. 2021.

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TABLE 1—ISSUED PERMITS AND PERMIT AMENDMENTS—Continued

Previous Federal Register Permit No. RTID Applicant notice Issuance date

25498 ...... 0648–XA914 ..... Titan Productions, Limited, 51–55 Whiteladies Road Bristol, 86 FR 12926; March 5, 2021 April 13, 2021. BS8 2LY, United Kingdom (Responsible Party: Lucy Meadows).

In compliance with the National assess the impact of our information Department of Commerce collections Environmental Policy Act of 1969 (42 collection requirements and minimize currently under review by OMB. U.S.C. 4321 et seq.), a final the public’s reporting burden. Public Written comments and determination has been made that the comments were previously requested recommendations for the proposed activities proposed are categorically via the Federal Register on January 13, information collection should be excluded from the requirement to 2021 during a 60-day comment period. submitted within 30 days of the prepare an environmental assessment or This notice allows for an additional 30 publication of this notice on the environmental impact statement. days for public comments. following website www.reginfo.gov/ As required by the ESA, as applicable, Agency: National Oceanic and public/do/PRAMain. Find this issuance of these permit was based on Atmospheric Administration. particular information collection by a finding that such permits: (1) Were Title: Protocol for Access to Tissue selecting ‘‘Currently under 30-day applied for in good faith; (2) will not Specimen Samples from the National Review—Open for Public Comments’’ or operate to the disadvantage of such Marine Mammal Tissue Bank. by using the search function and endangered species; and (3) are OMB Control Number: 0648–0468. entering either the title of the collection consistent with the purposes and Form Number(s): None. or the OMB Control Number 0648–0468. policies set forth in Section 2 of the Type of Request: Regular submission ESA. (extension of a current information Sheleen Dumas, Authority: The requested permits have collection). Department PRA Clearance Officer, Office of been issued under the MMPA of 1972, as Number of Respondents: 35. the Chief Information Officer, Commerce amended (16 U.S.C. 1361 et seq.), the Average Hours per Response: National Department. regulations governing the taking and Marine Mammal Tissue Bank Tissue [FR Doc. 2021–10048 Filed 5–11–21; 8:45 am] importing of marine mammals (50 CFR part Request Form, 3 hours; National Marine BILLING CODE 3510–22–P 216), the ESA of 1973, as amended (16 U.S.C. Mammal Tissue Bank Form, 45 minutes. 1531 et seq.), and the regulations governing Total Annual Burden Hours: 98. the taking, importing, and exporting of Needs and Uses: The purpose of this DEPARTMENT OF COMMERCE endangered and threatened species (50 CFR collection of information is to enable the parts 222–226), as applicable. National Oceanic and Atmospheric National Oceanic and Atmospheric Dated: May 6, 2021. Administration (NOAA) to allow the Administration Julia Marie Harrison, scientific community the opportunity to Chief, Permits and Conservation Division, request tissue specimen samples from Agency Information Collection Office of Protected Resources, National the National Marine Mammal Tissue Activities; Submission to the Office of Marine Fisheries Service. Bank (NMMTB), as well as for tissue Management and Budget (OMB) for [FR Doc. 2021–09976 Filed 5–11–21; 8:45 am] samples to be submitted. This Review and Approval; Comment Request; U.S. Pacific Highly Migratory BILLING CODE 3510–22–P information collection is being renewed to enable the Marine Mammal Health Species Hook and Line Logbook and Stranding Response Program The Department of Commerce will DEPARTMENT OF COMMERCE (MMHSRP) of NOAA to assemble submit the following information information on all specimens submitted National Oceanic and Atmospheric collection request to the Office of to the National Institute of Standards Administration Management and Budget (OMB) for and Technology’s National review and clearance in accordance Biomonitoring Specimen Bank (Bank), Agency Information Collection with the Paperwork Reduction Act of which includes the NMMTB. Activities; Submission to the Office of 1995, on or after the date of publication Management and Budget (OMB) for Affected Public: Individuals or households; Business or other for-profit of this notice. We invite the general Review and Approval; Comment public and other Federal agencies to Request; Protocol for Access to Tissue organizations; Not-for-profit institutions; State, Local, or Tribal comment on proposed, and continuing Specimen Samples From the National information collections, which helps us Marine Mammal Tissue Bank government; Federal government. Frequency: Reporting (on occasion). assess the impact of our information The Department of Commerce will Respondent’s Obligation: Mandatory. collection requirements and minimize submit the following information Legal Authority: Under 16 U.S.C. the public’s reporting burden. Public collection request to the Office of 1421f section 407(d)(1) of the Marine comments were previously requested Management and Budget (OMB) for Mammal Protection Act, the NMFS via the Federal Register on January 11, review and clearance in accordance must establish criteria for access to 2021 (86 FR 1943) during a 60-day with the Paperwork Reduction Act of marine mammal tissues in the NMMTB comment period. This notice allows for 1995, on or after the date of publication and make those available for public an additional 30 days for public of this notice. We invite the general comment and review. comments. public and other Federal agencies to This information collection request Agency: National Oceanic & comment on proposed, and continuing may be viewed at www.reginfo.gov. Atmospheric Administration (NOAA), information collections, which helps us Follow the instructions to view the Commerce.

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Title: U.S. Pacific Highly Migratory entering either the title of the collection about this information collection is also Species Hook and Line Logbook. or the OMB Control Number 0648–0223. available at http://www.reginfo.gov OMB Control Number: 0648–0223. under ‘‘Information Collection Review.’’ Sheleen Dumas, Form Number(s): NOAA 88–197. SUPPLEMENTARY INFORMATION: Department PRA Clearance Officer, Office of Type of Request: Regular submission the Chief Information Officer, Commerce I. Abstract (extension of a current information Department. The United States Patent and collection). [FR Doc. 2021–10063 Filed 5–11–21; 8:45 am] Number of Respondents: 1,700. Trademark Office (USPTO) administers BILLING CODE 3510–22–P Average Hours per Response: 1 hour. the Trademark Act, 15 U.S.C. 1051 et Total Annual Burden Hours: 3,400. seq., which provides for the Federal Needs and Uses: Under the Fishery DEPARTMENT OF COMMERCE registration of trademarks, service Management Plan for United States marks, collective trademarks and service (U.S.) West Coast Fisheries for Highly Patent and Trademark Office marks, collective membership marks, Migratory Species (HMS), U.S. anglers and certification marks. Individuals and participating in the Pacific hook-and- Agency Information Collection businesses that use or intend to use line (also known as the albacore troll Activities; Submission to the Office of such marks in commerce may file an and poll-and-line), coastal purse seine Management and Budget (OMB) for application to register their marks with (vessels less than 400 st carrying Review and Approval; Comment the USPTO. capacity), large-mesh drift gillnet, and Request; Trademark Post Registration This information collection covers various communications submitted by swordfish harpoon fisheries, are AGENCY: United States Patent and required to obtain an HMS permit. individuals and businesses to the Trademark Office, Department of USPTO occurring after registration of a Permit holders are also required to Commerce. complete and submit logbooks trademark. One type of communication ACTION: Notice of information collection; is a request to amend registrations to documenting their daily fishing request for comment. activities, including catch and effort for delete goods or services that are no each fishing trip. Logbook forms must SUMMARY: The United States Patent and longer being used by the registrant or be completed within 24 hours of the Trademark Office (USPTO), as required registration owner. Registered marks completion of each fishing day and by the Paperwork Reduction Act of remain on the register for 10 years and submitted to the Southwest Fisheries 1995, invites comments on the can be renewed, but will be cancelled Science Center (SWFSC) within 30 days extension and revision of an existing unless the registration owner files with of the end of each trip. Federal information collection: 0651–0055 the USPTO a declaration attesting to the regulations allow the use of state (Trademark Post Registration). The continued use (or excusable non-use) of logbooks to fulfill this requirement; for purpose of this notice is to allow 60 the mark in commerce, and a renewal example, Washington commercial days for public comment preceding application, within specific deadlines. passenger fishing vessels have fulfilled submission of the information collection Registration owners may also request to this requirement to date for HMS to OMB. amend or divide a registration, respond fisheries. These data and associated DATES: To ensure consideration, to a post-registration Office action, and analyses help the SWFSC provide comments regarding this information surrender a registration. The information in this information critical HMS fisheries information to collection must be received on or before collection is used to maintain the researchers, fisheries managers, and the July 12, 2021. quality of the trademark register. The needed management advice to the U.S. ADDRESSES: Interested persons are in its negotiations with foreign fishing register information may be accessed by invited to submit written comments by an individual or by businesses to nations that fish for HMS. any of the following methods. Do not Affected Public: Business or other for- determine the availability of a mark. By submit Confidential Business keeping the register current and profit organizations. Information or otherwise sensitive or Frequency: After each trip. accurate, parties may reduce the protected information. possibility of initiating use of a mark Respondent’s Obligation: Required to • Email: InformationCollection@ previously adopted by another. Obtain or Retain Benefits, and uspto.gov. Include ‘‘0651–0055 Mandatory. comment’’ in the subject line of the II. Methods of Collection Legal Authority: Magnuson-Stevens message. • Items in this information collection Fishery Conservation and Management Federal Rulemaking Portal: http:// must be submitted via online electronic Act. www.regulations.gov. • submissions through the Trademark This information collection request Mail: Kimberly Hardy, Office of the Electronic Application System (TEAS). may be viewed at www.reginfo.gov. Chief Administrative Officer, United In limited circumstances, applicants Follow the instructions to view the States Patent and Trademark Office, may also be permitted to submit the Department of Commerce collections P.O. Box 1450, Alexandria, VA 22313– information in paper form by mail or currently under review by OMB. 1450. hand delivery. Written comments and FOR FURTHER INFORMATION CONTACT: recommendations for the proposed Requests for additional information III. Data information collection should be should be directed to Catherine Cain, OMB Control Number: 0651–0055. submitted within 30 days of the Attorney Advisor, Office of the Form Numbers: publication of this notice on the Commissioner for Trademarks, United • PTO Form 1563 (Declaration of Use of following website www.reginfo.gov/ States Patent and Trademark Office, Mark in Commerce Under Section 8) public/do/PRAMain. Find this P.O. Box 1450, Alexandria, VA 22313– • PTO Form 1573 (Declaration of particular information collection by 1450; by telephone at 571–272–8946; or Incontestability of a Mark Under selecting ‘‘Currently under 30-day by email at [email protected] Section 15) Review—Open for Public Comments’’ or with ‘‘0651–0055 comment’’ in the • PTO Form 1583 (Combined by using the search function and subject line. Additional information Declaration of Use and

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Incontestability Under Sections 8 and • PTO Form 2310 (Request to Divide Estimated Time per Response: The 15) Registration) USPTO estimates that it takes the public • • PTO Form 1597 (Section 7 Request) PTO Form 2311 (Section 12(c) approximately between 10 minutes Affidavit) (0.17 hours) and 45 minutes (0.75 • PTO Form 1963 (Combined hours), depending on the complexity of Declaration of Use of Mark in Type of Review: Extension and the situation. This includes the time to Commerce and Application for revision of a currently approved gather the necessary information, Renewal of Registration of a Mark information collection. prepare the appropriate documents, and Under Sections 8 and 9) Affected Public: Private sector; submit the information to the USPTO. • individuals or households. PTO Form 2302 (Response to Office Estimated Number of Respondents: Estimated Total Annual Respondent Action for Post-Registration Matters) 219,694 respondents per year. Burden Hour: 113,620 hours. • PTO Form 2309 (Surrender of Estimated Number of Responses: Estimated Total Annual Respondent Registration for Cancellation) 219,694 responses per year. (Hourly) Cost Burden: $45,448,000. TABLE 1—BURDEN HOUR/BURDEN COST TO PRIVATE SECTOR RESPONDENTS

Estimated Estimated Estimated Estimated Estimated Item time for Rate 1 annual No. Item annual annual response burden ($/hour) respondent respondents responses (hours) (hour/year) cost burden

(a) (b) (a) × (b) = (c) (d) (c) × (d) = (e)

1 ...... Declaration of Use of Mark in Com- 11,932 11,932 0.50 (30 minutes) ...... 5,966 $400 $2,386,400 merce Under Section 8 (PTO Form 1563). 2 ...... Combined Declaration of Use of 70,235 70,235 0.50 (30 minutes) ...... 35,118 400 14,047,200 Mark in Commerce and Applica- tion for Renewal of Registration of a Mark Under Sections 8 & 9 (PTO Form 1963). 3 ...... Declaration of Incontestability of a 853 853 0.17 (10 minutes) ...... 145 400 58,000 Mark Under Section 15 (PTO Form 1573). 4 ...... Combined Declaration of Use and 72,448 72,448 0.50 (30 minutes) ...... 36,224 400 14,489,600 Incontestability Under Sections 8 and 15 (PTO Form 1583). 5 ...... Surrender of registration for can- 390 390 0.17 (10 minutes) ...... 66 400 26,400 cellation (PTO Form 2309). 6 ...... Section 7 Request (PTO Form 5,330 5,330 0.58 (35 minutes) ...... 3,091 400 1,236,400 1597). 7 ...... Response to Office Action for Post- 12,001 12,001 0.75 (45 minutes) ...... 9,001 400 3,600,400 Registration Matters (PTO Form 2302). 8 ...... Request to Divide Registration 2,566 2,566 0.50 (30 minutes) ...... 1,283 400 513,200 (PTO Form 2310). 9 ...... Section 12(c) Affidavit (PTO Form 1 1 0.25 (15 minutes) ...... 1 400 400 2311).

Total ...... 175,756 175,756 ...... 90,895 ...... 36,358,000

TABLE 2—BURDEN HOUR/BURDEN COST TO INDIVIDUAL OR HOUSEHOLD RESPONDENTS

Estimated Estimated Estimated Estimated Estimated 2 Item Item annual annual time for burden Rate annual No. respondents responses response (hour/year) ($/hour) respondent (hours) cost burden

(a) (b) (a) × (b) = (c) (d) (c) × (d) = (e)

1 ...... Declaration of Use of Mark in Com- 2,983 2,983 0.50 (30 minutes) ...... 1,492 $400 $596,800 merce Under Section 8 (PTO Form 1563). 2 ...... Combined Declaration of Use of 17,559 17,559 0.50 (30 minutes) ...... 8,780 400 3,512,000 Mark in Commerce and Applica- tion for Renewal of Registration of a Mark Under Sections 8 & 9 (PTO Form 1963). 3 ...... Declaration of Incontestability of a 213 213 0.17 (10 minutes) ...... 36 400 14,400 Mark Under Section 15 (PTO Form 1573). 4 ...... Combined Declaration of Use and 18,112 18,112 0.50 (30 minutes) ...... 9,056 400 3,622,400 Incontestability Under Sections 8 and 15 (PTO Form 1583). 5 ...... Surrender of registration for can- 98 98 0.17 (10 minutes) ...... 17 400 6,800 cellation (PTO Form 2309). 6 ...... Section 7 Request (PTO Form 1,332 1,332 0.58 (35 minutes) ...... 773 400 309,200 1597).

1 2019 Report of the Economic Survey, published Association (AIPLA); https://www.aipla.org/detail/ The USPTO uses the mean rate for attorneys in by the Committee on Economics of Legal Practice journal-issue/2019-report-of-the-economic-survey. private firms which is $400 per hour. of the American Intellectual Property Law

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TABLE 2—BURDEN HOUR/BURDEN COST TO INDIVIDUAL OR HOUSEHOLD RESPONDENTS—Continued

Estimated Estimated Estimated Estimated Estimated Item time for Rate 2 annual No. Item annual annual response burden ($/hour) respondent respondents responses (hours) (hour/year) cost burden

(a) (b) (a) × (b) = (c) (d) (c) × (d) = (e)

7 ...... Response to Office Action for Post- 3,000 3,000 0.75 (45 minutes) ...... 2,250 400 900,000 Registration Matters (PTO Form 2302). 8 ...... Request to Divide Registration 641 641 0.50 (30 minutes) ...... 321 400 128,400 (PTO Form 2310).

Total ...... 43,938 43,938 ...... 22,725 ...... 9,090,000

Estimated Total Annual (Non-hour) this information collection in the form depending on the number of classes. Respondent Cost Burden: $89,646,738. of filing fees ($89,646,625) and postage The filing fees shown here are based on This information collection has no costs ($113) is approximately the minimum fee of one class per capital startup, maintenance fees, or $89,646,738. document associated with this operating fees. However, this Filing Fees information collection. information collection does have filing fees and postage costs. The total annual Filing fees are charged per class of non-hour respondent cost burden for goods or services and can vary TABLE 3—FILING FEES (NON-HOUR) COST BURDEN TRADEMARK POST REGISTRATION

Estimated Estimated Item Item annual Estimated non-hour No. responses cost cost burden

(a) (b) (a) × (b) = (c)

1 ...... Declaration of Use of Mark in Commerce Under Section 8 ...... 14,915 $225 $3,355,875 2 ...... Combined Declaration of Use of Mark in Commerce and Application for Renewal of Registration of 87,791 525 46,090,275 a Mark Under Sections 8 & 9 (TEAS). 2 ...... Combined Declaration of Use of Mark in Commerce and Application for Renewal of Registration of 3 825 2,475 a Mark Under Sections 8 & 9 (paper). 2 ...... Issuing New Certificate of Registration ...... 200 100 20,000 2 ...... Certificate of Correction, Registrant’s Error (TEAS) ...... 6,463 100 646,300 2 ...... Certificate of Correction, Registrant’s Error (paper) ...... 1 200 200 3 ...... Declaration of Incontestability of a Mark Under Section 15 ...... 1,066 200 213,200 4 ...... Combined Declaration of Use and Incontestability Under Section 8 and 15 (TEAS) ...... 90,557 425 38,486,725 4 ...... Combined Declaration of Use and Incontestability Under Section 8 and 15 (paper) ...... 3 625 1,875 6 ...... Section 7 Request ...... 488 100 48,800 6–7 ..... Deletion of Goods or Services after submission and prior to acceptance of a section 8 affidavit 1,839 250 459,750 (TEAS). 6–7 ..... Deletion of Goods or Services after submission and prior to acceptance of a section 8 affidavit 1 350 350 (paper). 8 ...... Request to Divide Registration ...... 3,207 100 320,700 9 ...... Section 12(c) Affidavit ...... 1 100 100

Total ...... 89,646,625

Postage Costs IV. Request for Comments (c) Enhance the quality, utility, and clarity of the information to be Although the USPTO requires that the The USPTO is soliciting public collected; and items in this information collection be comments to: submitted electronically, the items may, (d) Minimize the burden of the (a) Evaluate whether the proposed in limited situations, be submitted by collection on those who are to respond, mail through the United States Postal collection of information is necessary including through the use of appropriate Service (USPS). The USPTO estimates for the proper performance of the automated, electronic, mechanical, or that the average postage cost for a functions of the Agency, including other technological collection mailed submission, using a Priority Mail whether the information shall have techniques or other forms of information 2-day flat rate legal envelope, will be practical utility; technology, e.g., permitting electronic $8.05. The USPTO estimates (b) Evaluate the accuracy of the submission of responses. approximately 14 submissions per year Agency’s estimate of the burden of the All comments submitted in response may be mailed to the USPTO, for a total proposed collection of information, to this notice are a matter of public postage cost of $113 per year. including the validity of the record. The USPTO will include or Respondent’s Obligation: Required to methodology and assumptions used; summarize each comment in the request obtain or retain benefits. to OMB to approve this information

2 2019 Report of the Economic Survey, published Association (AIPLA); https://www.aipla.org/detail/ The USPTO uses the mean rate for attorneys in by the Committee on Economics of Legal Practice journal-issue/2019-report-of-the-economic-survey. private firms which is $400 per hour. of the American Intellectual Property Law

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collection. Before including an address, opportunity to comment on proposed, current information on children’s early phone number, email address, or other revised, and continuing collections of learning and development, transitions personal identifying information (PII) in information. This helps the Department into kindergarten and beyond, and a comment, be aware that the entire assess the impact of its information progress through school. Collecting comment—including PII—may be made collection requirements and minimize parent data beginning in preschool will publicly available at any time. While the public’s reporting burden. It also enable the study to measure influences you may ask in your comment to helps the public understand the on children’s development before entry withhold PII from public view, the Department’s information collection into formal schooling, including USPTO cannot guarantee that it will be requirements and provide the requested children’s home environments and able to do so. data in the desired format. ED is access to early care and education. The soliciting comments on the proposed request to conduct a field test of the Kimberly Hardy, information collection request (ICR) that ECLS–K:2023 preschool data collection Information Collections Officer, Office of the is described below. The Department of activities from January through October Chief Administrative Officer, United States Education is especially interested in 2020, to field test the preschool data Patent and Trademark Office. public comment addressing the collection materials and procedures, [FR Doc. 2021–09972 Filed 5–11–21; 8:45 am] following issues: (1) Is this collection was approved in November 2019 (OMB# BILLING CODE 3510–16–P necessary to the proper functions of the 1850–0750 v.19), with change requests Department; (2) will this information be approved in January and July 2020 processed and used in a timely manner; (OMB #1850–0750 v.20–21). In April DEPARTMENT OF EDUCATION (3) is the estimate of burden accurate; 2021, OMB approved a one year study [Docket No.: ED–2021–SCC–0073] (4) how might the Department enhance delay (OMB #1850–0750 v.22), and the the quality, utility, and clarity of the study is now the Early Childhood Agency Information Collection information to be collected; and (5) how Longitudinal Study, Kindergarten Class Activities; Submission to the Office of might the Department minimize the of 2023–24 (ECLS–K:2024). This request Management and Budget for Review burden of this collection on the is to notify OMB and the public that, and Approval; Comment Request; respondents, including through the use following analysis of the results of the Early Childhood Longitudinal Study, of information technology. Please note preschool field test that was carried out Kindergarten Class of 2023–24 (ECLS– that written comments received in in 2020, NCES has decided not to go K:2024) Preschool Round Removal response to this notice will be forward with the national ECLS–K: 2024 Change Request considered public records. preschool round in spring 2023. No Title of Collection: Early Childhood other planned procedures or features of AGENCY: National Center for Education Longitudinal Study, Kindergarten Class the study will change. Approval for the Statistics (NCES), Institute of Education of 2023–24 (ECLS–K:2024) Preschool fall 2022 kindergarten-first grade field Sciences (IES), Department of Education Round Removal Change Request. test and national study recruitment will (ED). OMB Control Number: 1850–0750. be requested in a separate submission ACTION: Notice. Type of Review: No material or later in 2021. nonsubstantive change of a currently SUMMARY: In accordance with the approved information collection. Stephanie Valentine, Paperwork Reduction Act of 1995, ED is Respondents/Affected Public: PRA Coordinator, Strategic Collections and proposing a no material or Individuals or households. Clearance Governance and Strategy Division, nonsubstantive change to a currently Total Estimated Number of Annual Office of Chief Data Officer, Office of approved information collection. Responses: 46,033. Planning, Evaluation and Policy Development. DATES: Total Estimated Number of Annual Interested persons are invited to [FR Doc. 2021–09977 Filed 5–11–21; 8:45 am] submit comments on or before June 11, Burden Hours: 8,655. BILLING CODE 4000–01–P 2021. Abstract: The Early Childhood Longitudinal Study (ECLS) program, ADDRESSES: Written comments and conducted by the National Center for recommendations for proposed Education Statistics (NCES) within the ELECTION ASSISTANCE COMMISSION information collection requests should Institute of Education Sciences (IES) of be submitted within 30 days of the U.S. Department of Education (ED), Notice of Federal Advisory Committee publication of this notice to draws together information from Charter Renewals www.reginfo.gov/public/do/PRAMain. multiple sources to provide rich, Find this particular information AGENCY: U.S. Election Assistance descriptive data on child development, Commission. collection request by selecting early learning, and school progress. The ‘‘Department of Education’’ under ACTION: Notice of Federal Advisory ECLS program studies deliver national Committee charter renewals. ‘‘Currently Under Review,’’ then check data on children’s status at birth and at ‘‘Only Show ICR for Public Comment’’ various points thereafter; children’s SUMMARY: In accordance with the checkbox. transitions to nonparental care, early Federal Advisory Committee Act, the FOR FURTHER INFORMATION CONTACT: For care and education programs, and purpose of this notice is to announce specific questions related to collection school; and children’s experiences and that the Election Assistance activities, please contact Carrie Clarady, growth through the elementary grades. Commission (EAC) has renewed the 202–245–6347 or email The Early Childhood Longitudinal charters for the Board of Advisors, the [email protected]. Study, Kindergarten Class of 2022–23 Standards Board, and the Technical SUPPLEMENTARY INFORMATION: The (ECLS–K:2023) is the fourth cohort in Guidelines Development Committee for Department of Education (ED), in the series of early childhood a two-year period through April 13, accordance with the Paperwork longitudinal studies. The study will 2023. The Board of Advisors, the Reduction Act of 1995 (PRA) (44 U.S.C. advance research in child development Standards Board, and the Technical 3506(c)(2)(A)), provides the general and early learning by providing a Guidelines Development Committee are public and Federal agencies with an detailed and comprehensive source of federal advisory committees under the

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Federal Advisory Committee Act and (Commission or FERC) is soliciting Reliability Standard COM–001–3 created by the Help America Vote Act public comment on the currently (Communications), the associated of 2002. approved information collection, FERC– Implementation Plan, retirement of DATES: Renewed through April 13, 2023. 725V, Mandatory Reliability Standards: currently-effective Reliability Standard ADDRESSES: Election Assistance COM Reliability Standards. COM–001–2.1, and Violation Risk Commission, 633 3rd Street NW, Suite DATES: Comments on the collection of Factors (‘‘VRFs’’) and Violation Severity 200, Washington, DC 20001. information are due July 12, 2021. Levels (‘‘VSLs’’) associated with new To Obtain a Copy of the Charters: A ADDRESSES: You may submit copies of Requirements R12 and R13 in complete copy of the Charters are your comments (identified by Docket Reliability Standard COM–001–3. available from the EAC in electronic No. IC21–23–000) by one of the Reliability Standard COM–001–3 format. An electronic copy can be following methods: reflects revisions developed under downloaded in PDF format on the EAC’s Electronic filing through http:// Project 2015–07 Internal website, http://www.eac.gov. In order to www.ferc.gov, is preferred. Communications Capabilities, in obtain a paper copy of the Charters, • Electronic Filing: Documents must compliance with the Commission’s please mail your request to the U.S. be filed in acceptable native directive in Order No. 888 that NERC Election Assistance Commission FACA applications and print-to-PDF, but not ‘‘develop modifications to COM–001–2, Boards Management at 633 3rd Street in scanned or picture format. or develop a new standard, to address NW, Suite 200, Washington, DC 20001. • For those unable to file the Commission’s concerns regarding Please note that due to COVID–19 electronically, comments may be filed ensuring the adequacy of internal restrictions there are delays in by USPS mail or by hand (including communications capability whenever processing mailed requests and courier) delivery: internal communications could directly responses. Æ Mail via U.S. Postal Service Only: affect the reliability opera. FOR FURTHER INFORMATION CONTACT: Addressed to: Federal Energy Reliability Standards COM–001–3 and Kevin Rayburn, General Counsel, at Regulatory Commission, Secretary of the COM–002–4 do not require responsible 866–747–1471 (toll free) or 301–563– Commission, 888 First Street NE, entities to file information with the 3919. Email: [email protected]. Washington, DC 20426. Commission. COM–001–3 requires that SUPPLEMENTARY INFORMATION: Æ Hand (including courier) Delivery: The Board transmission operators, balancing of Advisors, the Standards Board, and Deliver to: Federal Energy Regulatory authorities, reliability coordinators, the Technical Guidelines Development Commission, 12225 Wilkins Avenue, distribution providers, and generator Committee are federal advisory Rockville, MD 20852. committees created by statute whose Instructions: All submissions must be operators must maintain documentation mission is to advise the EAC through formatted and filed in accordance with of Interpersonal Communication review of the voluntary voting systems submission guidelines at: http:// capability and designation of Alternate guidelines, review of voluntary www.ferc.gov. For user assistance, Interpersonal Communication, as well guidance, and review of best practices contact FERC Online Support by email as evidence of testing of the Alternate recommendations. In accordance with at [email protected], or by Interpersonal Communication facilities. the Federal Advisory Committee Act, phone at (866) 208–3676 (toll-free). COM–002–4 requires balancing Public Law 92–463, as amended, this Docket: Users interested in receiving authorities, distribution providers, notice advises interested persons of the automatic notification of activity in this reliability coordinators, transmission renewal of these Charters. docket or in viewing/downloading operators, and generator operators to comments and issuances in this docket develop and maintain documented Amanda Joiner, may do so at http://www.ferc.gov. communication protocols, and to be Associate Counsel, U.S. Election Assistance able to provide evidence of training on Commission. FOR FURTHER INFORMATION CONTACT: the protocols and of their annual [FR Doc. 2021–10023 Filed 5–11–21; 8:45 am] Ellen Brown may be reached by email at [email protected], telephone assessment of the protocols. BILLING CODE P at (202) 502–8663. Additionally, all applicable entities SUPPLEMENTARY INFORMATION: (balancing authorities, reliability coordinators, transmission operators, DEPARTMENT OF ENERGY Title: FERC–725V, Mandatory Reliability Standards: COM Reliability generator operators, and distribution Federal Energy Regulatory Standards. providers) must be able to provide Commission OMB Control No.: 1902–0277. evidence of three-part communication Type of Request: Three-year extension when issuing or receiving an Operating [Docket No. IC21–23–000] of the FERC–725V information Instruction during an Emergency. Commission Information Collection collection requirements with no changes Type of Respondents: Public utilities. to the reporting requirements. Activities (FERC–725V); Comment Estimate of Annual Burden: 3 The Abstract: On August 15, 2016, the Request; Extension Commission estimates the annual public North American Electric Reliability reporting burden for the information AGENCY: Federal Energy Regulatory Corporation (NERC) filed a petition for Commission, Department of Energy. Commission approval, pursuant to collection as: ACTION: Notice of information collection section 215(d)(1) of the Federal Power and request for comments. Act (‘‘FPA’’) 1 and Section 39.5 2 of the 3 The Commission defines burden as the total Federal Energy Regulatory time, effort, or financial resources expended by SUMMARY: In compliance with the Commission’s regulations, for persons to generate, maintain, retain, or disclose or provide information to or for a Federal agency. For requirements of the Paperwork further explanation of what is included in the Reduction Act of 1995, the Federal 1 16 U.S.C. 824o (2012). information collection burden, reference 5 Code of Energy Regulatory Commission 2 18 CFR 39.5 (2015). Federal Regulations 1320.3.

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FERC–725V—MANDATORY RELIABILITY STANDARDS: COM RELIABILITY STANDARDS

Total annual Annual Average burden Cost per Number of number of Total number burden hours and respondent respondents responses per of responses and cost per total annual cost 4 ($) respondent response ($)

(1) (2) (1) * (2) = (3) (4) (3) * (4) = (5) (5) ÷ (1)

(On-going) Maintain evidence of Interpersonal 1,313 (BA, DP, GOP, 1 1,313 4 hrs.; $228 ..... 5,252 hrs.; $299,364 .. $228 Communication capability 5. RC & TOP). (On-going) Maintain evidence of training and 199 (BA, RC & TOP) .. 1 199 8 hrs.; 456 ...... 1,592 hrs.; 90,744 ...... 456 assessments 6. (On-going) Maintain evidence of training 7 ...... 1,257 (DP & GOP) ...... 1 1,257 8 hrs.; 456 ...... 10,056 hrs.; 573,192 .. 456

Total ...... 2,769 ...... 16,900 hrs.; 963,300 ......

Comments: Comments are invited on: DEPARTMENT OF ENERGY www.ferc.gov. Persons unable to file (1) Whether the collection of electronically may mail similar information is necessary for the proper Federal Energy Regulatory pleadings to the Federal Energy performance of the functions of the Commission Regulatory Commission, 888 First Street Commission, including whether the [Docket No. RP21–813–000] NE, Washington, DC 20426. Hand information will have practical utility; delivered submissions in docketed (2) the accuracy of the agency’s estimate Spire Marketing Inc. v. Panhandle proceedings should be delivered to of the burden and cost of the collection Eastern Pipe Line Company, LP; Health and Human Services, 12225 of information, including the validity of Notice of Complaint Wilkins Avenue, Rockville, Maryland 20852. the methodology and assumptions used; Take notice that on April 30, 2021, In addition to publishing the full text (3) ways to enhance the quality, utility pursuant to Section 5 of the Natural Gas of this document in the Federal and clarity of the information collection; Act 1 and Rule 206 of the Federal Energy Register, the Commission provides all and (4) ways to minimize the burden of Regulatory Commission’s (Commission) interested persons an opportunity to the collection of information on those Rules of Practice and Procedure, 18 CFR view and/or print the contents of this who are to respond, including the use 385.206 (2020), Spire Marketing Inc. document via the internet through the of automated collection techniques or (Complainant) filed a formal complaint Commission’s Home Page (http:// other forms of information technology. against Panhandle Eastern Pipe Line ferc.gov) using the ‘‘eLibrary’’ link. Company, LP (Respondent), alleging Dated: May 6, 2021. Enter the docket number excluding the that the Respondent’s failure to waive last three digits in the docket number Debbie-Anne A. Reese, operational flow order penalties field to access the document. At this Deputy Secretary. incurred after February 15, 2021 is time, the Commission has suspended [FR Doc. 2021–10008 Filed 5–11–21; 8:45 am] unduly discriminatory and inconsistent access to the Commission’s Public BILLING CODE 6717–01–P with Commission policy and precedent, Reference Room, due to the all as more fully explained in its proclamation declaring a National complaint. Emergency concerning the Novel The Complainant certify that copies of Coronavirus Disease (COVID–19), issued the complaint were served on the by the President on March 13, 2020. For contacts listed for Respondent in the assistance, contact the Federal Energy Commission’s list of Corporate Officials. Any person desiring to intervene or to Regulatory Commission at protest this filing must file in [email protected], or call accordance with Rules 211 and 214 of toll-free, (886) 208–3676 or TYY, (202) the Commission’s Rules of Practice and 502–8659. Procedure (18 CFR 385.211, 385.214). Comment Date: 5:00 p.m. Eastern 4 The estimates for cost per response are loaded Protests will be considered by the Time on May 20, 2021. hourly wage figure (includes benefits) is based on Commission in determining the Dated: May 6, 2021. two occupational categories for 2020 found on the appropriate action to be taken, but will Debbie-Anne A. Reese, Bureau of Labor Statistics website (http:// not serve to make protestants parties to www.bls.gov/oes/current/naics2_22.htm): The Deputy Secretary. hourly estimates for salary plus benefits are: (a) the proceeding. Any person wishing to [FR Doc. 2021–10010 Filed 5–11–21; 8:45 am] become a party must file a notice of Electrical Engineer (code 17–2071), $70.19; (b) BILLING CODE 6717–01–P Information and Record Clerk (code 43–4199), intervention or motion to intervene, as $43.38. The average hourly cost (salary plus appropriate. The Respondent’s answer benefits), weighting both skill sets equally, is and all interventions, or protests must DEPARTMENT OF ENERGY $56.79. For these calculations, we round the figure be filed on or before the comment date. to $57.00 per hour. The Respondent’s answer, motions to Federal Energy Regulatory 5 For COM–001–3 the BA, RC, TOP, GOP, DP intervene, and protests must be served Commission were taken as aggregate to eliminate overlap if the on the Complainant. same entity has multiple registrations. The Commission strongly encourages Combined Notice of Filings 6 For COM–002–4 the BA, RC and TOP were taken as aggregate to eliminate overlap if the same electronic filings of comments, protests and interventions in lieu of paper using Take notice that the Commission has entity has multiple registration. received the following Natural Gas 7 the ‘‘eFiling’’ link at http:// For COM–002–4 the DP and GOP were taken as Pipeline Rate and Refund Report filings: aggregate to eliminate overlap if the same entity has multiple registrations. 1 15 U.S.C. 717d. Docket Numbers: RP21–757–000.

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Applicants: Cheyenne Plains Gas Accession Number: 20210429–5065. DEPARTMENT OF ENERGY Pipeline Company, L.L.C. Comments Due: 5 p.m. ET 5/11/21. Description: § 4(d) Rate Filing: Annual Federal Energy Regulatory Fuel and LU Update and OPS Report to Docket Numbers: RP21–765–000. Commission be effective 6/1/2021. Applicants: Colorado Interstate Gas Combined Notice of Filings #1 Filed Date: 4/29/21. Company, L.L.C. Accession Number: 20210429–5014. Description: § 4(d) Rate Filing: Take notice that the Commission Comments Due: 5 p.m. ET 5/11/21. Negotiated Rate Non-Conforming TSA received the following electric corporate Docket Numbers: RP21–758–000. (BHSC Elkhart) and Housekeeping filings: Applicants: Wyoming Interstate Filing to be effective 6/1/2021. Docket Numbers: EC21–88–000. Company, L.L.C. Filed Date: 4/29/21. Applicants: KES Kingsburg, L.P. Description: § 4(d) Rate Filing: Fuel Description: Application for and L&U Quarterly Update to be Accession Number: 20210429–5140. Authorization Under Section 203 of the effective 6/1/2021. Comments Due: 5 p.m. ET 5/11/21. Federal Power Act of KES Kingsburg, Filed Date: 4/29/21. L.P. Accession Number: 20210429–5015. Docket Numbers: RP21–766–000. Filed Date: 5/5/21. Comments Due: 5 p.m. ET 5/11/21. Applicants: Southern Star Central Gas Accession Number: 20210505–5186. Docket Numbers: RP21–759–000. Pipeline, Inc. Comments Due: 5 p.m. ET 5/26/21. Applicants: Sierrita Gas Pipeline LLC. Description: § 4(d) Rate Filing: Vol 2— Take notice that the Commission Description: § 4(d) Rate Filing: FL&U Neg and Conforming Rate Agreements- received the following exempt Quarterly Update Filing to be effective Southwest Energy PLS to be effective wholesale generator filings: 6/1/2021. 5/1/2021. Docket Numbers: EG21–140–000. Filed Date: 4/29/21. Applicants: Orangeville Energy Accession Number: 20210429–5016. Filed Date: 4/29/21. Storage LLC. Comments Due: 5 p.m. ET 5/11/21. Accession Number: 20210429–5156. Description: Notice of Self- Docket Numbers: RP21–760–000. Comments Due: 5 p.m. ET 5/11/21. Certification of Exempt Wholesale Applicants: Kinetica Energy Express, Generator Status of Orangeville Energy Docket Numbers: RP21–767–000. LLC. Storage LLC. Description: § 4(d) Rate Filing: Section Applicants: Gas Transmission Filed Date: 5/4/21. 4 Rate Case to be effective 6/1/2021. Northwest LLC. Accession Number: 20210504–5190. Filed Date: 4/29/21. Description: § 4(d) Rate Filing: GTN Comments Due: 5 p.m. ET 5/25/21. Accession Number: 20210429–5021. Neg Rate Agreements to be effective Take notice that the Commission Comments Due: 5 p.m. ET 5/11/21. 11/1/2019. received the following electric rate Docket Numbers: RP21–761–000. filings: Applicants: Ruby Pipeline, L.L.C. Filed Date: 4/29/21. Docket Numbers: ER17–1214–004; Description: § 4(d) Rate Filing: FLU Accession Number: 20210429–5225. ER11–3917–003. and Electric Power Update to be Comments Due: 5 p.m. ET 5/11/21. Applicants: Mojave Solar LLC, Coso effective 6/1/2021. Geothermal Power Holdings, LLC. Filed Date: 4/29/21. The filings are accessible in the Description: Notice of Change in Accession Number: 20210429–5039. Commission’s eLibrary system (https:// Status of Coso Geothermal Power Comments Due: 5 p.m. ET 5/11/21. elibrary.ferc.gov/idmws/search/ Holdings, LLC, et al. Docket Numbers: RP21–762–000. fercgensearch.asp) by querying the docket number. Filed Date: 5/6/21. Applicants: Gulfstream Natural Gas Accession Number: 20210506–5048. System, L.L.C. Any person desiring to intervene or Comments Due: 5 p.m. ET 5/27/21. protest in any of the above proceedings Description: § 4(d) Rate Filing: 2021 Docket Numbers: ER12–1436–016; must file in accordance with Rules 211 GNGS TUP/SBA Filing to be effective ER10–2742–015; ER14–153–009; ER14– and 214 of the Commission’s 6/1/2021. 154–009; ER15–1604–004; ER16–517– Regulations (18 CFR 385.211 and Filed Date: 4/29/21. 004; ER18–533–003; ER18–534–003; 385.214) on or before 5:00 p.m. Eastern Accession Number: 20210429–5041. ER18–535–003; ER18–536–003; ER18– time on the specified comment date. Comments Due: 5 p.m. ET 5/11/21. 537–003; ER18–538–004; ER20–1641– Protests may be considered, but Docket Numbers: RP21–763–000. 002. Applicants: Alliance Pipeline L.P. intervention is necessary to become a Applicants: Tilton Energy LLC, Description: Alliance Pipeline L.P. party to the proceeding. Dynegy Lee II, LLC, Eagle Point Power submits Annual report for operational eFiling is encouraged. More detailed Generation LLC, Gibson City Energy purchase and sales for the 12-month information relating to filing Center, LLC, Grand Tower Energy period ending December 31, 2020 under requirements, interventions, protests, Center, LLC, Lee County Generating RP21–763. service, and qualifying facilities filings Station, LLC, Montepelier Generating Filed Date: 4/29/21. can be found at: http://www.ferc.gov/ Station, LLC, Monument Generating Accession Number: 20210429–5062. docs-filing/efiling/filing-req.pdf. For Station, LLC, O.H. Hutchings CT, LLC, Comments Due: 5 p.m. ET 5/11/21. other information, call (866) 208–3676 Shelby County Energy Center, LLC, Docket Numbers: RP21–764–000. (toll free). For TTY, call (202) 502–8659. Sidney, LLC, Southern Illinois Applicants: Sabal Trail Transmission, Dated: April 30, 2021. Generation Company, LLC, Tait Electric LLC. Generating Station, LLC, Yankee Street, Kimberly D. Bose, Description: § 4(d) Rate Filing: 2021 LLC. TUP/SBA Annual Filing to be effective Secretary. Description: Notice of Non-Material 6/1/2021. [FR Doc. 2021–09987 Filed 5–11–21; 8:45 am] Change in Status of Rockland Sellers. Filed Date: 4/29/21. BILLING CODE 6717–01–P Filed Date: 5/5/21.

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Accession Number: 20210505–5185. Accession Number: 20210505–5188. Comments Due: 5 p.m. ET 5/27/21. Comments Due: 5 p.m. ET 5/26/21. Comments Due: 5 p.m. ET 5/26/21. Docket Numbers: ER21–1861–000. Docket Numbers: ER19–1073–004; Docket Numbers: ER21–1006–000; Applicants: BP Energy Company. ER10–2460–019; ER10–2461–020; ER21–1007–000. Description: § 205(d) Rate Filing: ER10–2463–019; ER10–2466–020; Applicants: El Paso Electric Company. Revised Market-Based Rate Tariff Filing ER10–2895–022; ER10–2917–022; Description: EL Paso Electric to be effective 7/6/2021. ER10–2918–023; ER10–2920–022; Company submits response to the Filed Date: 5/6/21. ER10–2921–022; ER10–2922–022; Commission’s March 29, 2021 letter. Accession Number: 20210506–5060. ER10–2966–022; ER10–3167–014; Filed Date: 4/28/21. Comments Due: 5 p.m. ET 5/27/21. ER11–2201–023; ER11–2383–018; Accession Number: 20210428–5220. Docket Numbers: ER21–1862–000. ER11–3941–020; ER11–3942–025; Comments Due: 5 p.m. ET 5/19/21. Applicants: Cedar Creek II, LLC. Description: § 205(d) Rate Filing: ER11–4029–019; ER12–1311–019; Docket Numbers: ER21–1401–001. Revised Market-Based Rate Tariff Filing ER12–161–024; ER12–2068–019; ER12– Applicants: Northern States Power to be effective 7/6/2021. 645–025; ER12–682–020; ER13–1139– Company, a Wisconsin corporation, Filed Date: 5/6/21. 022; ER13–1346–013; ER13–1613–015; Northern States Power Company, a Accession Number: 20210506–5067. ER13–17–017; ER13–203–014; ER13– Minnesota corporation. Comments Due: 5 p.m. ET 5/27/21. 2143–015; ER14–1964–013; ER14–25– Description: Tariff Amendment: 2021 Docket Numbers: ER21–1863–000. 019; ER14–2630–015; ER16–287–008; Interchange Agreement Annual Filing- Applicants: Alabama Power ER17–482–007; ER19–1074–007; ER19– Stay to be effective 12/31/9998. Company. 1075–007; ER19–1076–004; ER19–2429– Filed Date: 5/5/21. Description: § 205(d) Rate Filing: RE 005; ER19–529–007; ER20–1447–003; Accession Number: 20210505–5179. Sumter (Sumter County Solar) Amended ER20–1806–003. Comments Due: 5 p.m. ET 5/26/21. and Restated LGIA Filing to be effective Applicants: Alta Wind VIII, LLC, Bear Docket Numbers: ER21–1506–001. 4/9/2021. Swamp Power Company LLC, BIF II Applicants: Shaw Creek Solar, LLC. Filed Date: 5/6/21. Safe Harbor Holdings, LLC, BIF III Description: Tariff Amendment: Shaw Accession Number: 20210506–5094. Holtwood LLC, Bishop Hill Energy LLC, Creek Solar, LLC Amendment to the Comments Due: 5 p.m. ET 5/27/21. Black Bear Development Holdings, LLC, Application for MBR Authority to be The filings are accessible in the Black Bear Hydro Partners, LLC, Black effective 5/23/2021. Commission’s eLibrary system (https:// Bear SO, LLC, Blue Sky East, LLC, BREG Filed Date: 5/5/21. elibrary.ferc.gov/idmws/search/ Aggregator LLC, Brookfield Energy Accession Number: 20210505–5178. fercgensearch.asp) by querying the Marketing Inc., Brookfield Energy Comments Due: 5 p.m. ET 5/26/21. docket number. Marketing LP, Brookfield Energy Docket Numbers: ER21–1752–001. Any person desiring to intervene or Marketing US LLC, Brookfield Power Applicants: Public Service Company protest in any of the above proceedings Piney & Deep Creek LLC, Brookfield of New Mexico. must file in accordance with Rules 211 Renewable Energy Marketing US, Description: Tariff Amendment: and 214 of the Commission’s Brookfield Renewable Trading and Supplement to First Revised Service Regulations (18 CFR 385.211 and Marketing LP, Brookfield Smoky Agreement No. 398 to be effective 5/6/ 385.214) on or before 5:00 p.m. Eastern Mountain Hydropower LP, Brookfield 2021. time on the specified comment date. White Pine Hydro LLC, California Ridge Filed Date: 5/5/21. Protests may be considered, but Wind Energy LLC, Canandaigua Power Accession Number: 20210505–5170. intervention is necessary to become a Partners, LLC, Canandaigua Power Comments Due: 5 p.m. ET 5/26/21. party to the proceeding. Partners II, LLC, Catalyst Old River eFiling is encouraged. More detailed Hydroelectric Limited Partnership, Carr Docket Numbers: ER21–1858–000. information relating to filing Street Generating Station, L.P., Erie Applicants: Northern States Power requirements, interventions, protests, Boulevard Hydropower, L.P., Erie Wind, Company, a Minnesota corporation. service, and qualifying facilities filings LLC, Evergreen Wind Power, LLC, Description: § 205(d) Rate Filing: can be found at: http://www.ferc.gov/ Evergreen Wind Power III, LLC, Granite CapX Brookings OMA–537–0.1.0-Filing docs-filing/efiling/filing-req.pdf. For Reliable Power, LLC, Great Lakes Hydro to be effective 7/5/2021. other information, call (866) 208–3676 America, LLC, Hawks Nest Hydro LLC, Filed Date: 5/5/21. (toll free). For TTY, call (202) 502–8659. Imperial Valley Solar 1, LLC, Mesa Accession Number: 20210505–5153. Comments Due: 5 p.m. ET 5/26/21. Dated: May 6, 2021. Wind Power Corporation, Niagara Wind Debbie-Anne A. Reese, Power, LLC, Prairie Breeze Wind Energy Docket Numbers: ER21–1859–000. Deputy Secretary. LLC, Regulus Solar, LLC, Rumford Falls Applicants: Arizona Public Service Hydro LLC, Safe Harbor Water Power Company. [FR Doc. 2021–10007 Filed 5–11–21; 8:45 am] Corporation, Stetson Holdings, LLC, Description: Notice of Cancellation of BILLING CODE 6717–01–P Stetson Wind II, LLC, Vermont Wind, Rate Schedule No. 214 of Arizona LLC, Windstar Energy, LLC. Public Service Company. DEPARTMENT OF ENERGY Description: Notice of Non-Material Filed Date: 5/5/21. Change in Status of Alta Wind VIII, LLC, Accession Number: 20210505–5175. Federal Energy Regulatory et al. Comments Due: 5 p.m. ET 5/26/21. Commission Filed Date: 5/5/21. Docket Numbers: ER21–1860–000. Accession Number: 20210505–5191. Applicants: CenterPoint Energy [Docket No. IC21–25–000] Comments Due: 5 p.m. ET 5/26/21. Houston Electric, LLC. Commission Information Collection Docket Numbers: ER21–44–002. Description: § 205(d) Rate Filing: TFO Activities (Ferc–552); Comment Applicants: Altavista Solar, LLC. Interim Tariff Rate Revision to Conform Request; Extension Description: Notice of Change in with PUCT to be effective 4/30/2021. Status of Altavista Solar, LLC. Filed Date: 5/6/21. AGENCY: Federal Energy Regulatory Filed Date: 5/5/21. Accession Number: 20210506–5023. Commission, Department of Energy.

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ACTION: Notice of information collection Regulatory Commission, Secretary of the collection requirements with no changes and request for comments. Commission, 888 First Street NE, to the current reporting requirements. Washington, DC 20426. Abstract: The Commission uses the SUMMARY: In compliance with the Æ Hand (including courier) Delivery: information collected in the FERC Form requirements of the Paperwork Deliver to: Federal Energy Regulatory No. 552 1 to provide greater Reduction Act of 1995, the Federal Commission, 12225 Wilkins Avenue, transparency into the size of the Energy Regulatory Commission Rockville, MD 20852. physical natural gas market and the use (Commission or FERC) is soliciting Instructions: All submissions must be of physical fixed-price and index-based public comment on the currently formatted and filed in accordance with natural gas transactions. This approved information collection, FERC– submission guidelines at: http:// information assists the Commission and 552, (Annual Report of Natural Gas www.ferc.gov. For user assistance, the public in assessing whether index Transactions). contact FERC Online Support by email prices are the result of a robust market DATES: Comments on the collection of at [email protected], or by of fixed-price transactions. information are due July 12, 2021. phone at (866) 208–3676 (toll-free). FERC Form No. 552 had its genesis in ADDRESSES: You may submit copies of Docket: Users interested in receiving the Energy Policy Act of 2005,2 which your comments (identified by Docket automatic notification of activity in this added section 23 of the Natural Gas Act No. IC21–25–000) by one of the docket or in viewing/downloading (NGA). Section 23 of the NGA, among following methods: comments and issuances in this docket other things, directs the Commission ‘‘to Electronic filing through http:// may do so at http://www.ferc.gov. facilitate price transparency in markets for the sale or transportation of physical www.ferc.gov, is preferred. FOR FURTHER INFORMATION CONTACT: • natural gas in interstate commerce, Electronic Filing: Documents must Ellen Brown may be reached by email having due regard for the public be filed in acceptable native at [email protected], telephone interest, the integrity of those markets, applications and print-to-PDF, but not at (202) 502–8663. in scanned or picture format. and the protection of consumers.’’ 3 • For those unable to file SUPPLEMENTARY INFORMATION: Type of Respondents: Wholesale electronically, comments may be filed Title: FERC Form No. 552, Annual natural gas market participants. by USPS mail or by hand (including Report of Natural Gas Transactions. Estimate of Annual Burden: 4 The courier) delivery: OMB Control No.: 1902–0242. Commission estimates the average Æ Mail via U.S. Postal Service Only: Type of Request: Three-year extension annual burden and cost 5 for this Addressed to: Federal Energy of the FERC Form No. 552 information information collection as follows. FERC FORM NO. 552—ANNUAL REPORT OF NATURAL GAS TRANSACTIONS

Annual Annual number Average burden Total annual burden cost per Category Number of of responses Total number hours and cost hours and cost respondent respondents per respondent of responses per response ($) ($) (rounded)

(1) (2) (1) * (2) = (3) (4) (3) * (4) = (5) (5) ÷ (1)

Wholesale natural gas market 688 1 688 20 hrs.; $1,702.60 ...... 13,760 hrs.; $1,171,388.80 ...... $1,702.60 participants.

Comments: Comments are invited on: Dated: May 6, 2021. ENVIRONMENTAL PROTECTION (1) Whether the collection of Debbie-Anne A. Reese, AGENCY information is necessary for the proper Deputy Secretary. performance of the functions of the [FR Doc. 2021–10009 Filed 5–11–21; 8:45 am] [EPA–HQ–OW–2021–0169; FRL–10023–19– OW] Commission, including whether the BILLING CODE 6717–01–P information will have practical utility; National Pollutant Discharge (2) the accuracy of the agency’s estimate Elimination System (NPDES) 2022 of the burden and cost of the collection Issuance of General Permit for of information, including the validity of Stormwater Discharges From the methodology and assumptions used; Construction Activities (3) ways to enhance the quality, utility and clarity of the information collection; AGENCY: Environmental Protection and (4) ways to minimize the burden of Agency (EPA). the collection of information on those ACTION: Notice; request for public who are to respond, including the use comment. of automated collection techniques or other forms of information technology. SUMMARY: All ten Environmental Protection Agency (EPA) Regions are

1 FERC Form No. 552 is prescribed in 18 CFR information to or for a Federal agency. Refer to 5 work is done by a financial analyst (code 13–2098) 260.401. CFR 1320.3 for additional information. at an hourly cost of $66.09 (for wages plus benefits), 2 Energy Policy Act of 2005, Public Law 109–58, 5 Costs (for wages and benefits) are based on wage and 25% of the work is done by legal staff members sections 1261 et seq., 119 Stat. 594 (2005). figures from the Bureau of Labor Statistics (BLS) for (code 23–0000) at an hourly cost of $142.25 (for 3 15 U.S.C. 717t–2(a)(1)(2006). May 2020 (at https://www.bls.gov/oes/current/ wages plus benefits). Therefore, the weighted cost 4 Burden is defined as the total time, effort, or naics2_22.htm) and benefits information (issued (for wages plus benefits) is calculated to $85.13/ financial resources expended by persons to March 2020, https://www.bls.gov/news.release/ hour [or ($66.09/hour * 0.75) + ($142.25/hour * generate, maintain, retain, or disclose or provide ecec.nr0.htm). The staff estimates that 75% of the 0.25)].

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proposing for public comment on the ADDRESSES: Submit your comments, C. What should I consider as I prepare my proposed 2022 National Pollutant identified by Docket ID No. EPA–HQ– comments for EPA? Discharge Elimination System (NPDES) OW–2021–0169 to the Federal D. Will a public hearing be held on this general permit for stormwater eRulemaking Portal: http:// action? E. What process will EPA follow to finalize discharges from construction activities, www.regulations.gov. Follow the online the permit? also referred to as the ‘‘proposed 2022 instructions for submitting comments. F. Who are the EPA regional contacts for Construction General Permit (CGP)’’ or Once submitted, comments cannot be this permit? the ‘‘proposed permit.’’ The proposed edited or withdrawn. EPA may publish II. Background of Permit permit, once finalized, will replace the any comment received to its public A. Technology-Based Effluent Limits existing 2017 CGP that will expire on docket. Do not submit electronically any B. Water Quality-Based Effluent Limits February 16, 2022. EPA proposes to information you consider to be (WQBELs) issue this permit for five (5) years, and Confidential Business Information (CBI) III. Process Used To Identify Proposed Permit or other information whose disclosure is Changes to provide permit coverage to eligible IV. Summary of Proposed Permit Changes operators in all areas of the country restricted by statute. Multimedia A. Changes to Clarity of the Permit where EPA is the NPDES permitting submissions (audio, video, etc.) must be B. Added Specificity to Permit authority, including Massachusetts, accompanied by a written comment. Requirements New Hampshire, New Mexico, most The written comment is considered the V. Provisions for Which EPA Is Soliciting Indian country lands, the District of official comment and should include Comment Columbia, U.S. territories and discussion of all points you wish to VI. Paperwork Reduction Act (PRA) protectorates except for the U.S. Virgin make. EPA will generally not consider VII. Proposed 2022 CGP Incremental Cost Islands, and certain federal facilities. comments or comment contents located Analysis and Future Cost-Benefit outside of the primary submission (i.e. Considerations EPA seeks comment on the proposed VIII. Executive Order 12866: Regulatory permit and on the accompanying fact on the web, cloud, or other file sharing Planning and Review and Executive sheet, which contains supporting system). For additional submission Order 13563: Improving Regulation and documentation. This Federal Register methods, the full EPA public comment Regulatory Review document describes the proposed policy, information about CBI or IX. Executive Order 12898: Federal Actions permit in general and includes specific multimedia submissions, and general To Address Environmental Justice in topics on which the Agency is guidance on making effective Minority Populations and Low-Income particularly seeking comment. EPA comments, please visit https:// Populations encourages the public to read the fact www.epa.gov/dockets/commenting-epa- X. Executive Order 13175: Consultation and dockets. Coordination With Indian Tribal sheet to better understand the proposed Governments permit. The fact sheet and proposed FOR FURTHER INFORMATION CONTACT: For XI. Executive Order 13211: Actions That permit can be found at https:// further information on the proposed Significantly Affect Energy Supply, www.epa.gov/npdes/stormwater- permit, contact the appropriate EPA Distribution, or Use discharges-construction-activities. XII. Compliance With the National Regional office listed in Section I.F of Environmental Policy Act (NEPA) for the DATES: Comments on the proposed this document, or Greg Schaner, EPA National Pollutant Discharge Elimination permit must be received on or before Headquarters, Office of Water, Office of System (NPDES) General Permit for July 12, 2021. EPA will host at least one Wastewater Management at 202–564– Discharges From Construction Activities webcast during the week of June 14, 0721 or email: [email protected]. I. General Information 2021 that will provide an overview of SUPPLEMENTARY INFORMATION: This the proposed 2022 CGP and an section is organized as follows: A. Does this action apply to me? opportunity for participants to ask questions. EPA will announce details of Table of Contents 1. Entities Covered by This Permit all webcasts and post webcast I. General Information This proposed permit covers the recordings at https://www.epa.gov/ A. Does this action apply to me? following entities, as categorized in the npdes/stormwater-discharges- B. How can I get copies of these documents North American Industry Classification construction-activities. and other related information? System (NAICS):

TABLE 1—ENTITIES COVERED BY THIS PROPOSED PERMIT

North American Industry Category Examples of affected entities Classification System (NAICS) Code

Industry ...... Construction site operators disturbing one or more acres of land, or less than one acre but part of a larger common plan of development or sale if the larger common plan will ultimately disturb 1 acre or more, and performing the following activities:

Construction of Buildings ...... 236

Heavy and Civil Engineering Construction ...... 237

EPA does not intend the preceding could potentially be affected by this by this action, you should carefully table to be exhaustive but provides it as action. Other types of entities not listed examine the definition of ‘‘construction a guide for readers regarding the types in the table could also be affected. To activity’’ and ‘‘small construction of activities EPA is now aware of that determine whether your site is covered activity’’ in existing EPA regulations at

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40 CFR 122.26(b)(14)(x) and production of oil or gas or geothermal Center homepage at https:// 122.26(b)(15), respectively. If you have resources, including transportation of www.epa.gov/dockets. Although not all questions regarding the applicability of crude oil or natural gas by pipeline, as docket materials may be available this action to a particular entity, consult both states are now authorized to issue electronically, you may still access any one of the persons listed for technical permits for construction stormwater. of the publicly available docket information in the preceding FOR Eligible operators in these two states materials through the Docket Facility FURTHER INFORMATION CONTACT section. will need to seek permit coverage for identified in Section I.B.1 of this their stormwater discharges from their preamble. 2. Construction Projects for Which respective state NPDES authority. Operators Are Eligible for Permit C. What should I consider as I prepare Coverage B. How can I get copies of these my comments for EPA? Coverage under this permit will be documents and other related 1. Submitting CBI. Do not submit CBI available to operators of eligible projects information? information to EPA through located in those areas where EPA is the 1. Docket. EPA has established an www.regulations.gov or email. Clearly permitting authority. A list of eligible official public docket for this action mark the part or all of the information areas is included in Appendix B of the under Docket ID No. EPA–HQ–OW– that you claim to be CBI. For CBI proposed permit. Eligibility for permit 2021–0169. The official public docket is information in a disk or CD ROM that coverage is limited to operators of ‘‘new the collection of materials that is you mail to EPA, mark the outside of the sites,’’ operators of ‘‘existing sites,’’ available for public viewing at the Water disk or CD ROM as CBI and then ‘‘new operators of new or existing Docket in the EPA Docket Center, (EPA/ identify electronically within the disk or sites,’’ and operators of ‘‘emergency- DC) WJC West Building, Room 3334, CD ROM the specific information that is related projects.’’ A ‘‘new site’’ is a site 1301 Constitution Ave. NW, claimed as CBI. In addition to one where construction activities Washington, DC 20460. Although all complete version of the comment that commenced on or after the effective date documents in the docket are listed in an includes information claimed as CBI, a of the final 2022 CGP. An ‘‘existing site’’ index, some information is not publicly copy of the comment that does not is a site where construction activities available, i.e., Confidential Business contain the information claimed as CBI commenced prior to the effective date of Information (CBI) or other information must be submitted for inclusion in the the final 2022 CGP. A ‘‘new operator of whose disclosure is restricted by statute. public docket. Information so marked a new or existing site’’ is an operator Out of an abundance of caution for will not be disclosed except in that through transfer of ownership and/ members of the public and our staff, the accordance with procedures set forth in or operation replaces the operator of an EPA Docket Center and Reading Room 40 CFR part 2. already permitted construction site. An are closed to the public, with limited EPA’s policy is that public comments, ‘‘emergency-related project’’ is a project exceptions, to reduce the risk of whether submitted electronically or in initiated in response to a public transmitting COVID–19. Our Docket paper, will be made available for public emergency (e.g., mud slides, earthquake, Center staff will continue to provide viewing in EPA’s electronic public extreme flooding conditions, disruption remote customer service via email, docket as EPA receives them and in essential public services), for which phone, and webform. We encourage the without change, unless the comment the related work requires immediate public to submit comments via https:// contains copyrighted material, CBI, or authorization to avoid imminent www.regulations.gov/ or email, as there other information whose disclosure is endangerment to human health or the may be a delay in processing mail and restricted by statute. As noted environment, or to reestablish public faxes. Hand deliveries and couriers may previously, CBI information should not services. be received by scheduled appointment be submitted through regulations.gov or only. For further information on EPA by email. When EPA identifies a 3. Geographic Coverage Docket Center services and the current comment containing copyrighted This 2022 CGP can provide coverage status, please visit us online at https:// material, EPA will provide a reference to eligible operators for stormwater www.epa.gov/dockets. to that material in the version of the discharges from construction activities 2. Electronic Access. You may access comment that is placed in EPA’s that occur in areas not covered by an this Federal Register document electronic public docket. The entire approved state NPDES program. The electronically through the United States printed comment, including the areas of geographic coverage for the government on-line source for Federal copyrighted material, will be available 2022 CGP are listed in Appendix B, and regulations at http:// in the public docket. include the states of New Hampshire, www.regulations.gov. Public comments submitted on Massachusetts, and New Mexico, as Electronic versions of this proposed computer disks that are mailed or well as most Indian country lands, and permit and fact sheet are available on delivered to the docket will be areas in selected states operated by a EPA’s NPDES website at https:// transferred to EPA’s electronic public federal operator. Permit coverage can www.epa.gov/npdes/stormwater- docket. Public comments that are also be obtained by operators in Puerto discharges-construction-activities. mailed or delivered to the docket will be Rico, the District of Columbia, and the An electronic version of the public scanned and placed in EPA’s electronic Pacific Island territories (i.e., Island of docket is available through the EPA’s public docket. Where practical, physical American Samoa, Island of Guam, and electronic public docket and comment objects will be photographed, and the Johnston Atoll, Commonwealth of the system, EPA Dockets. You may use EPA photograph will be placed in EPA’s Northern Mariana Islands, Midway Dockets at http://www.regulations.gov to electronic public docket along with a Island, and Wake Island). EPA notes submit or view public comments, access brief description written by the docket that the CGP will no longer offer the index listing of the contents of the staff. coverage to construction sites in the official public docket, and to access 2. Tips for Preparing Your Comments. state of Idaho, except for sites located on those documents in the public docket When submitting comments, remember Indian country lands, or to sites located that are available electronically. For to: in the state of Texas that involve the additional information about EPA’s • Identify this proposed permit by exploration, development, or public docket, visit the EPA Docket docket number and other identifying

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information (subject heading, Federal all webcasts and post webcast ‘‘to restore and maintain the chemical, Register date and page number). recordings at https://www.epa.gov/ physical, and biological integrity of the • Where possible, respond to specific npdes/stormwater-discharges- Nation’s waters.’’ 33 U.S.C. 1251(a). The questions or organize comments by construction-activities. CWA also includes the objective of referencing a section or part of this attaining ‘‘water quality which provides proposed permit. E. What process will EPA follow to for the protection and propagation of • Explain why you agree or disagree; finalize the permit? fish, shellfish and wildlife and * * * suggest alternatives and substitute After the comment period closes, EPA recreation in and on the water.’’ 33 language for your requested changes. intends to issue a final permit prior to U.S.C. 1251(a)(2)). To achieve these • Describe any assumptions and the expiration date of the current 2017 goals, the CWA requires EPA to control provide any technical information and/ CGP. EPA will consider all significant discharges of pollutants from point or data that you used. comments and make appropriate sources through the issuance of National • If you estimate potential costs or changes before issuing this permit. Pollutant Discharge Elimination System burdens, explain how you arrived at EPA’s responses to public comments (NPDES) permits. your estimate in sufficient detail to received will be included in the docket The Water Quality Act of 1987 (WQA) allow for it to be reproduced. as part of the final permit issuance. added section 402(p) to the CWA, which • Provide specific examples to Once the final permit becomes effective, directed EPA to develop a phased illustrate your concerns and suggest eligible operators of existing and new approach to regulate stormwater alternatives. sites may seek authorization under the discharges under the NPDES program. • Explain your views as clearly as 2022 CGP. Any construction site 33 U.S.C. 1342(p). EPA published a final possible, avoiding the use of profanity operator obtaining permit coverage prior regulation in the Federal Register, often or personal threats. called the ‘‘Phase I Rule,’’ on November • to the expiration date of the 2017 CGP To ensure that EPA can read, will automatically remain covered 16, 1990, establishing permit understand, and therefore properly under that permit until the earliest of: application requirements for, among respond to comments, the Agency • Authorization for coverage under other things, ‘‘storm water discharges would prefer that commenters cite, the 2022 CGP following a timely associated with industrial activity.’’ See where possible, the paragraph(s) or submittal of a complete and accurate 55 FR 47990. EPA defines the term section in the proposed permit or fact Notice of Intent (NOI); ‘‘storm water discharge associated with sheet to which each comment refers. • industrial activity’’ in a comprehensive • Submittal of a Notice of Make sure to submit your Termination (NOT); or manner to cover a wide variety of comments by the comment period • EPA issues an individual permit or facilities. See id. Construction activities, deadline identified. denies coverage under an individual including activities that are part of a D. Will a public hearing be held on this permit for the site’s stormwater larger common plan of development or action? discharges. sale, that ultimately disturb at least five acres of land and have point source EPA has not scheduled a public F. Who are the EPA regional contacts for discharges to waters of the U.S. were hearing to receive public comment this permit? included in the definition of ‘‘industrial concerning the proposed permit. All For EPA Region 1, contact David activity’’ pursuant to 40 CFR persons will continue to have the right Gray: email at [email protected]. 122.26(b)(14)(x). The second rule to provide written comments during the For EPA Region 2, contact Stephen implementing section 402(p), often public comment period. However, Venezia: email at venezia.stephen@ called the ‘‘Phase II Rule,’’ was interested persons may request a public epa.gov, or for Puerto Rico, contact published in the Federal Register on hearing pursuant to 40 CFR 124.12 Sergio Bosques: email at December 8, 1999. It requires NPDES concerning the proposed permit. [email protected]. permits for discharges from construction Requests for a public hearing must be For EPA Region 3, contact Carissa sites disturbing at least one acre but less sent or delivered in writing to the same Moncavage: email at than five acres, including sites that are address as provided above for public [email protected]. part of a larger common plan of comments prior to the close of the For EPA Region 4, contact Michael development or sale that will ultimately comment period. Requests for a public Mitchell: email at mitchell.michael@ disturb at least one acre but less than hearing must state the nature of the epa.gov. five acres, pursuant to 40 CFR issues proposed to be raised in the For EPA Region 5, contact Krista 122.26(b)(15)(i). See 64 FR 68722. EPA hearing. Pursuant to 40 CFR 124.12, McKim: email at [email protected]. is proposing to issue this proposed EPA shall hold a public hearing if it For EPA Region 6, contact Suzanna permit under the statutory and finds, on the basis of requests, a Perea: email at: [email protected]. regulatory authorities cited in this significant degree of public interest in a For EPA Region 7, contact Mark section. public hearing on the proposed permit. Matthews: email at: matthews.mark@ NPDES permits for construction If EPA decides to hold a public hearing, epa.gov. stormwater discharges are required a public notice of the date, time and For EPA Region 8, contact Amy Clark: under Section 402(a)(1) of the CWA to place of the hearing will be made at email at: [email protected]. include conditions to meet technology- least 30 days prior to the hearing. Any For EPA Region 9, contact Eugene based effluent limits established under person may provide written or oral Bromley: email at bromley.eugene@ Section 301 and, where applicable, statements and data pertaining to the epa.gov. Section 306. Effluent Limitations proposed permit at the public hearing. For EPA Region 10, contact Margaret Guidelines (ELGs) and New Source EPA is hosting at least one public McCauley: email at mccauley.margaret@ Performance Standards (NSPS) are webcast during the week of June 14, epa.gov. technology-based effluent limitations 2021 that will provide an overview of that are based on the degree of control the proposed 2022 CGP and an II. Background of Permit that can be achieved using various opportunity for participants to ask The Clean Water Act (CWA) levels of pollutant control technology as questions. EPA will announce details of establishes a comprehensive program defined in Subchapter III of the CWA.

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Once a new national standard is a minimum, such controls must be are prohibited unless managed by established in accordance with these designed, installed, and maintained to: appropriate controls. sections, NPDES permits must 1. Control stormwater volume and • Pollution Prevention Measures— incorporate limits based on such velocity to minimize soil erosion in Permittees are required to design, technology-based standards. See CWA order to minimize pollutant discharges; install, implement, and maintain sections 301 and 306, 33 U.S.C. 1311 2. Control stormwater discharges, effective pollution prevention measures and 1316, and 40 CFR 122.44(a)(1). On including both peak flow rates and total to minimize the discharge of pollutants. December 1, 2009, EPA published final stormwater volume, to minimize At a minimum, such measures must be regulations establishing technology- channel and streambank erosion, and designed, installed, implemented, and based ELGs and NSPS for the scour in the immediate vicinity of maintained to: Construction & Development (C&D) discharge points; 1. Minimize the discharge of point source category, which became 3. Minimize the amount of soil pollutants from equipment and vehicle effective on February 1, 2010. See 40 exposed during construction activity; washing, wheel wash water, and other CFR part 450 and 74 FR 62996. EPA 4. Minimize the disturbance of steep wash waters. Wash waters must be amended the Construction & slopes; treated in a sediment basin or Development Rule, or ‘‘C&D rule,’’ on 5. Minimize sediment discharges from alternative control that provides March 6, 2014 to satisfy EPA’s the site. The design, installation and equivalent or better treatment prior to agreements pursuant to a settlement of maintenance of erosion and sediment discharge; litigation that challenged the 2009 rule. controls must address factors such as See 79 FR 12661. All NPDES the amount, frequency, intensity and 2. Minimize the exposure of building construction permits issued by EPA or duration of precipitation, the nature of materials, building products, states after this date must incorporate resulting stormwater discharge, and soil construction wastes, trash, landscape the requirements in the C&D rule. characteristics, including the range of materials, fertilizers, pesticides, A. Technology-Based Effluent Limits soil particle sizes expected to be present herbicides, detergents, sanitary waste, on the site; and other materials present on the site All NPDES construction stormwater 6. Provide and maintain natural to precipitation and to stormwater. permits issued by EPA or states after Minimization of exposure is not March 6, 2014, must incorporate the buffers around waters of the United States. Direct stormwater to vegetated required in cases where the exposure to requirements in the C&D rule, as precipitation and to stormwater will not amended. The non-numeric effluent areas and maximize stormwater infiltration to reduce pollutant result in a discharge of pollutants or limitations in the C&D rule are designed where exposure of a specific material or to prevent or minimize the mobilization discharges, unless infeasible; 7. Minimize soil compaction. product poses little risk of stormwater and discharge of sediment and contamination (such as final products sediment-bound pollutants, such as Minimizing soil compaction is not required where the intended function of and materials intended for outdoor use); metals and nutrients, and to prevent or and minimize exposure of stormwater to a specific area of the site dictates that it construction materials, debris, and other be compacted; and 3. Minimize the discharge of sources of pollutants on construction 8. Unless infeasible, preserve topsoil. pollutants from spills and leaks and sites. In addition, these non-numeric Preserving topsoil is not required where implement chemical spill and leak effluent limitations limit the generation the intended function of a specific area prevention and response procedures. of dissolved pollutants. Soil on of the site dictates that the topsoil be • Prohibited Discharges—The construction sites can contain a variety disturbed or removed. following discharges from C&D sites are • of pollutants such as nutrients, Soil Stabilization Requirements— prohibited: Permittees are required to, at a pesticides, herbicides, and metals. 1. Wastewater from washout of These pollutants may be present minimum, initiate soil stabilization measures immediately whenever any concrete, unless managed by an naturally in the soil, such as arsenic or appropriate control; selenium, or they may have been clearing, grading, excavating, or other contributed by previous activities on the earth disturbing activities have 2. Wastewater from washout and site, such as agriculture or industrial permanently ceased on any portion of cleanout of stucco, paint, form release activities. These pollutants, once the site or temporarily ceased on any oils, curing compounds, and other mobilized by stormwater, can detach portion of the site and will not resume construction materials; from the soil particles and become for a period exceeding 14 calendar days. 3. Fuels, oils, or other pollutants used dissolved pollutants. Once dissolved, In arid, semiarid, and drought-stricken in vehicle and equipment operation and these pollutants would not be removed areas where initiating vegetative maintenance; and by down-slope sediment controls. stabilization measures immediately is 4. Soaps or solvents used in vehicle Source control through minimization of infeasible, alternative stabilization and equipment washing. soil erosion is, therefore, the most measures must be employed as specified • Surface Outlets—When discharging effective way of controlling the by the permitting authority. from basins and impoundments, discharge of these pollutants. Stabilization must be completed within The non-numeric effluent limits in a period of time determined by the permittees are required to utilize outlet the C&D rule, upon which certain permitting authority. In limited structures that withdraw water from the technology-based requirements in the circumstances, stabilization may not be surface, unless infeasible. proposed permit are based, include the required if the intended function of a The accompanying fact sheet details following: specific area of the site necessitates that how EPA has incorporated these • Erosion and Sediment Controls— it remains disturbed. requirements into the proposed permit. Permittees are required to design, • Dewatering Requirements— The discussion in the fact sheet install, and maintain effective erosion Permittees are required to minimize the includes a summary of each provision controls and sediment controls to discharge of pollutants from dewatering and the Agency’s rationale for minimize the discharge of pollutants. At trenches and excavations. Discharges articulating the provision in this way.

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B. Water Quality-Based Effluent Limits III. Process Used To Identify Proposed permittees, EPA compliance staff, or (WQBELs) Permit Changes other stakeholders have raised EPA’s regulations at 40 CFR EPA made a concerted effort in the questions. These changes generally do 122.44(d)(1) require permitting early stages of developing this proposed not change the underlying requirement authorities to include additional or permit to reach out to stakeholders that from the 2017 CGP, but rather attempt to make EPA’s original intent clearer. It more stringent permit requirements would be affected by any modifications is EPA’s hope that these proposed when necessary to achieve water quality to the permit requirements. This clarifications improve the overall standards. The 2017 CGP contains outreach included meetings with understanding of the permit’s several provisions to protect water stakeholders representing the requirements from all perspectives, quality and the proposed permit construction industry, environmental including the permitting authority, includes those same provisions. It interests, and state permitting permittees, and the general public. includes a narrative WQBEL requiring authorities. The purpose of these The proposed changes to improve that discharges be controlled as meetings was to help identify areas of clarity include the following: necessary to meet applicable water the 2017 CGP that require further • Approved stormwater control and quality standards. Failure to control clarification or modification to more stormwater pollution prevention plan discharges in a manner that meets effectively achieve the pollutant products—EPA includes new language applicable water quality standards is a reduction objectives of the permit. EPA in the permit to clearly state that the violation of the permit. also queried its Regional enforcement Agency does not endorse specific In addition to the narrative WQBEL, personnel to determine where the stormwater control or stormwater the 2017 CGP includes related permit could be clarified or where pollution prevention plan (SWPPP) provisions that act together to protect further specifics would help improve products or vendors. Industry water quality. These provisions are compliance. The individual feedback stakeholders suggested to include such retained in the proposed 2022 CGP. For obtained from these meetings informed language to help discourage some example, the 2017 CGP and proposed the types of clarifications and other vendors from misleadingly suggesting 2022 CGP permit require permittees to changes EPA is proposing here, as well that EPA or the permit approves of implement stormwater control measures as the areas where the Agency is specific products. See footnotes 12 and and to take corrective action in response soliciting further feedback during the 59 in Parts 2.1 and 7.1, respectively, of to any exceedance of applicable water public comment period. the proposed permit. quality standards. In addition, the • Differentiate between routine permit requires more stringent site IV. Summary of Proposed Permit Changes maintenance and corrective action— inspection frequencies and stabilization EPA proposes to define routine deadlines for construction sites that EPA proposes to make several maintenance as repairs to or discharge to sensitive waters, such as modifications in the 2022 CGP, which replacement of stormwater controls that those waters that are sediment or are summarized below and discussed in can be completed within 24 hours of nutrient-impaired, which are parameters more detail in the fact sheet. EPA also first discovering the need for the repair typically associated with stormwater specifically requests comment on or replacement. If a repair (or discharges from construction sites, or several potential permit modifications, replacement) takes longer than 24 hours, waters identified by a state, tribe, or which are summarized in Section V of the permit would require that it be EPA as requiring enhanced protection this document. The fact sheet for the treated as a corrective action. This under antidegradation requirements. proposed permit explains in more detail change addresses feedback provided by EPA is also weighing whether to include each proposed permit condition and the industry stakeholders who have an additional water quality-based rationale for including those conditions observed that there is considerable requirement for dewatering discharges and any changes to those conditions. confusion about which maintenance to certain sensitive waters in the form of The fact sheet and proposed permit can repairs are considered routine versus a requirement to monitor the discharge be found at https://www.epa.gov/npdes/ those that should be treated as for turbidity, possibly in comparison to stormwater-discharges-construction- corrective actions. See Parts 2.1.4.b and a benchmark value. The proposed activities. A comprehensive list of all c, and 5.1.1 of the proposed permit. permit includes a request for public the proposed changes, as well as the • Clarify application of perimeter comment that is focused specifically on corresponding parts of the permit that control and natural buffer the potential turbidity monitoring are modified, is included in a table in requirements—EPA understands from requirement. See specific requests for Section III.B of the fact sheet. conversations with stakeholders that comment in Section V of this document. The types of changes generally fall there is confusion about whether Additionally, EPA expects that, as into one of two categories: (1) Changes perimeter controls are necessary on the with the 2017 CGP, the Agency will to improve the clarity of the permit, and site when the operator is already receive CWA Section 401 certifications (2) added specificity to the permit providing a natural buffer pursuant to for the final 2022 CGP. Some of those requirements. The table of proposed the requirements of the permit. To certifications may include additional modifications in Section III.B of the fact address this confusion, EPA clarifies conditions that are required by states, sheet specifies which changes fall under that perimeter controls must be installed Indian tribes, and territories, pursuant the type (1) category and which fall into upgradient of any natural buffers except to relevant provisions of the Clean the type (2) category. The following in situations where the perimeter Water Act or their respective legal sections briefly describe the proposed control is being used by the permittee to authorities, and that, when properly changes that are proposed within these fulfill one of the buffer alternative submitted, will be incorporated into the two broad categories. requirements, in which case the permit as legally binding permit limits permittee would not be required to A. Changes to Clarity of the Permit and conditions in the specific install a second perimeter control. See geographic areas that are located within EPA proposes a number of relatively Part 2.2.3.a of the proposed permit. the jurisdiction of the certifying minor changes that focus on improving • Clarify the permit flexibilities for authority. the clarity of provisions where arid and semi-arid areas—The 2017

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CGP establishes alternative stabilization retaining documents in electronic form EPA is proposing additional perimeter and inspection schedules for arid and is currently included in a frequently control installation and maintenance semi-arid areas that are reflective of the asked question section of its stormwater requirements that are focused on different climatic and precipitation website (see https://www.epa.gov/ ensuring that these controls continue to conditions that exist in those areas. npdes/construction-general-permit-cgp- work effectively. For example, under the These stabilization and inspection frequent-questions), and is not clearly proposed provision, if there is evidence schedule flexibilities apply during the stated in the permit. For this reason, the of stormwater circumventing or ‘‘seasonally dry period’’ of the year proposed permit includes text to make undercutting the perimeter control after when there is less risk of a discharge- it clear that electronic versions of the a storm event, the operator would be producing storm event. The permit did SWPPP, inspection reports, and required to extend the length of the not previously define the term corrective action logs may be used as perimeter control or repair any undercut ‘‘seasonally dry period,’’ and EPA has long as they meet certain minimum areas, whichever applies. This change is received a number of questions from requirements. See footnotes 54, 55, and intended to ensure that maintenance of construction operators over the past 66 to Parts 4.7.3, 5.4.3, and 7.3, these controls is focused on fixing several years about what this term respectively, of the proposed permit. problems as soon as they are found and means. For this reason, the proposed • Updated process for Endangered making sure they work effectively when permit establishes a new definition to Species Act eligibility determinations— the next storm event occurs. See Part provide clarity, and includes resources EPA proposes several updates to 2.2.3 of the proposed permit. in the form of maps and zip code tables Appendix D of the CGP, which • Pollution prevention requirements to assist construction operators located establishes procedures for operators to for chemicals used and stored on site— in an arid or semi-arid area in follow in determining their eligibility EPA is proposing changes to the determining when they may be for coverage with respect to the pollution prevention requirements for operating during a seasonally dry period protection of endangered and threatened diesel fuel, oil, hydraulic fuels, or other of the year. See Parts 2.2.14.b, 2.2.14.c, species. The changes to Appendix D are petroleum products, and other and 4.4.2 of the proposed permit, as primarily in the form of clarifications to chemicals. These proposed changes well as the definition of ‘‘seasonally dry existing procedures or updates to respond to feedback EPA received from period’’ in Appendix A. resources that operators can use to some permittees who recommended • Clarified requirements for determine whether species are located reframing the current permit inspections during snowmelt in the ‘‘action area’’ of the construction requirements so they are proportionate conditions—The permit proposes to add site. EPA finalized similar changes as to the volume of chemicals being used a numeric inspection threshold for part of the Endangered Species Act and stored on the site, and relative to snowfall precipitation that is equivalent consultation it completed as part of its the risk of a spill or leak. EPA agrees to the 0.25-inch rain event, which issuance of the 2021 Multi-Sector that the requirements in this section triggers the need for an inspection if the General Permit (MSGP) for discharges could be improved by strengthening the operator chooses to inspect its site on a from industrial activities (See Appendix linkage between the type of pollution bi-weekly basis pursuant to Part 4.2.2. E of the 2021 MSGP at https:// prevention control needed and the This change would clarify that where www.epa.gov/npdes/stormwater- volume of the pollutant kept on site. there is a discharge from snowmelt discharges-industrial-activities-epas- Consistent with this principle, the caused by an accumulation of 3.25 2021-msgp). See Appendix D of the proposed permit establishes control inches or greater of snow, an inspection proposed permit. requirements that are appropriate for would be required. Permit holders smaller-sized containers by requiring B. Added Specificity to Permit requested this change and explained to that the operator use water-tight Requirements EPA that without a numeric threshold, containers, place them on a spill it is difficult for operators to know EPA is proposing select modifications containment pallet (or similar device) if which snow events may trigger the need to the permit to address specific kept outside, and have a spill kit to inspect the site during the winter problems that have come to the available at all times and in good season. EPA relied on information from Agency’s attention during the permit working condition, and personnel the National Oceanic and Atmospheric term or to incorporate enhancements available to respond quickly to a spill or Administration (NOAA) to derive the that reflect current best practices. These leak. These controls will be effective at 3.25-inch snowfall equivalent to the proposed changes are narrowly focused preventing a discharge from a spill or 0.25-inch rain event. See Part 4.2.2 of on specific topics. The following is a leak, while also having the added the proposed permit. summary of these proposed changes: advantage of being moved more easily • Availability of stormwater pollution • Perimeter control installation and around the site. The proposed permit prevention plan (SWPPP), inspection maintenance requirements—Due to the also includes controls that are more reports, and corrective action log in vital role that sediment controls suitable to larger volumes of chemicals electronic form—The 2017 CGP installed along the downslope side of on site, such as requiring a temporary currently enables operators to keep their the construction site perimeter play in roof or secondary containment to SWPPP, inspection reports, and minimizing sediment discharges, it is prevent a discharge from a leak or spill. corrective action records in electronic important for the CGP requirements See Part 2.3.3.c of the proposed permit. form, as long as it can be accessed and related to these controls to reflect best • Dewatering discharge read by the permittee and by any EPA, practices that are available, effective, requirements—EPA is proposing several state, or local inspection authorities in and practicable. Reviewing a number of changes to the permit’s dewatering the same manner as a paper copy. EPA state permits and best management requirements to improve compliance heard from permittees, however, who practice manuals during the and further reduce pollutant loads to were uncertain about whether the development of the proposed permit, waterways. EPA has noted violations flexibility to keep these documents in EPA concluded that some targeted with the permit’s dewatering electronic form was available to them. proposed changes to the perimeter requirements at sites with controls that EPA acknowledges that part of the control requirements in the CGP are are improperly installed and problem is that its explanation about appropriate at this time. For this reason, maintained, resulting in significant

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discharges of sediment and other number are not. EPA proposes to The intent of this proposed addition is pollutants to receiving waters. Given the address this problem is by strengthening to emphasize that the site inspection is high rate at which dewatered water may the training requirements for inspection an ideal time to examine whether there be discharged, EPA inspection personnel to ensure their competency to are any obvious signs of sedimentation personnel have observed that it is conduct such inspections. For this attributable to the site’s discharges, and possible that a site may discharge more reason, the proposed permit specifies to require documentation of such sediment in several hours of poorly that anyone carrying out inspections sedimentation. EPA does not specify in managed dewatering activities than must either (1) have completed the new the permit a specific distance might otherwise be discharged from a EPA construction inspection course downstream of the site that operators site via stormwater discharges over the developed for this permit and passed much check for sedimentation that entire course of the construction project. the exam, or (2) hold a current valid could be attributable to the discharge, Additionally, EPA has found there to be certification or license from a program given variable site-specific conditions. good example provisions from state that covers essentially the same Instead, EPA expects that operators will construction stormwater permits and principles as EPA’s inspection course. account for the amount of sediment standalone NPDES dewatering permits The proposal also includes an exception leaving the site in determining this that can be used to strengthen the CGP’s to the new training requirement if the distance. EPA notes that the CGP dewatering conditions. personnel are working under the already requires operators to check for The proposed revisions to the permit supervision of a person who has the met signs of visible erosion and add clarity to the existing pollutant the qualifications described above. sedimentation (i.e., sediment deposits) control provisions, increase the number These new proposed requirements are that have occurred and are attributable of inspections required while the essentially an extension of what the to the permittee’s discharge at outfalls dewatering discharge is occurring, 2017 CGP (and 2012 CGP) already and, if applicable, on the banks of any establish a tailored checklist of required for the ‘‘qualified person’’ to waters of the U.S. flowing within or problems to review during the conduct inspections. EPA is in the immediately adjacent to the site. See inspection, and identify specific triggers Part 4.6.1.d of the proposed permit. process of developing a construction • for when corrective action is required. inspection training program that will be Photo documentation of adequate For example, one new inspection made available as an option to fulfill site stabilization—EPA’s compliance provision would require the operator to this new requirement to CGP permittees inspectors have observed cases when check whether a sediment plume, along with an accompanying exam that, operators prematurely terminate sheen, or hydrocarbon deposit on the if passed, will provide the person with coverage under the CGP before the site bottom or shoreline of the receiving documentation showing that they have is properly stabilized. The proposed water was observed during a dewatering successfully completed the EPA course. permit adds a new provision requiring discharge. If such a plume, sheen, or EPA plans to have the training program operators as part of their Notice of deposit is observed, the permit would ready for use by the issuance of the final Termination (NOT) to take and submit require the operator to, among other 2022 CGP, or to delay the photographs showing the stabilized things, take immediate steps to suspend implementation of the requirement until areas of the site following completion of the discharge and ensure that the the EPA training is available. construction. EPA proposes this dewatering controls being used are Documentation that the relevant requirement primarily as an additional level of proof that permittees are operating effectively. During an personnel has completed the EPA inspection of the dewatering operation, complying with the stabilization course and passed the exam will serve the operator would also be required to requirements prior to terminating as proof that the operator has met the take photographs of (1) the dewatering coverage. Given the importance of new inspection training requirements. water prior to treatment by a stormwater stabilization to preventing continuing Alternatively, if the relevant personnel control(s) and the final discharge after erosion and sedimentation, EPA views elect to obtain the required training treatment; (2) the stormwater control; the additional proposed photo through a different program that covers and (3) the point of discharge to any documentation requirement to be a the same basic principles, the operator waters of the U.S. flowing through or relatively inexpensive, effective, and will need to provide documentation that immediately adjacent to the site. This straightforward way for the permittee to these personnel have completed the documentation will help demonstrate show the Agency that it has complied how well the dewatering controls are program and are in possession of a with the permit’s final stabilization working and will show where current, valid certification or license. requirements. See Part 8.2.1.a of the adaptations made after any problems See Parts 4.1 and 6.3 of the proposed proposed permit. Related to this have been found have resulted in permit. proposed new requirement, EPA is also improved pollutant control. See Parts • Documenting signs of adding a check box to the NOT form to 2.4, 4.3.2, 4.5.5, 4.6.3, and 5.1.5 of the sedimentation attributable to confirm that the operator has attached proposed permit. construction site discharges—EPA photographs as required by Part 8.2.1.a • Training requirements for personnel specifies in the proposed permit that to document compliance with the conducting site inspections—EPA is during the inspection, operators must permit’s final stabilization proposing to include modifications to check for signs of sedimentation (e.g., requirements. the training requirements for personnel sand bars with no vegetation growing on • Notice of Intent (NOI) questions— conducting site inspections. EPA top) at points downstream from the EPA proposes to add new questions to considers these changes reasonable to point of discharge that could be the NOI form that construction address problems found during many of attributable to their discharges. This operators will use to obtain coverage the Agency’s own construction site change is intended to address a frequent under the 2022 CGP. One question asks inspections, in which EPA has observed problem observed during EPA’s operators if dewatering water will be that while some permittees are properly compliance inspections that the discharged during the course of their conducting inspections and permittee does not document obvious permit coverage. While EPA suspects documenting their findings in signs that its discharges have caused that most CGP-covered projects accordance with the permit, a large sedimentation in the receiving water. discharge dewatering water during

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construction, it would be useful to the from coverage under this permit due to approval to the Office of Management Agency to know what the prevalence of the possibility of discharging and Budget (OMB) under the PRA. The this practice is at its permitted sites. dewatering water that is contaminated, Information Collection Request (ICR) This question will provide a and whether certain sites should be document that EPA prepared has been straightforward way of compiling given case-by-case flexibility if assigned EPA ICR No. 2686.01, OMB information broadly about permittees stormwater contact with underground Control No. 2040–NEW. You can find a and enable EPA to know which contamination has been prevented copy of the ICR in the docket for this permittees may be affected by the through implementation of cleanup permit (Docket ID No. EPA–HQ–OW– permit’s new proposed dewatering controls, such as capping. See Request 2021–0169), and it is briefly requirements. Another question asks the for Comment 2 in Part 1.3.6 of the summarized here. operator completing the NOI whether proposed permit. CWA section 402 and the NPDES there are other operators who are also 3. Waiting period for discharge regulations require collection of covered by the CGP at the same site and, authorization—Request for comment on information primarily used by if so, what their NPDES ID numbers are. whether to extend the waiting period permitting authorities, permittees Because the 2017 CGP NOI does not ask between the operator’s submittal of the (operators), and EPA to make NPDES the operator to indicate whether there NOI and the authorization to discharge permitting decisions. The burden and are multiple operators permitted for the from 14 days to 30 days to facilitate costs associated with the entire NPDES same site, EPA is often unable to easily review of the site’s eligibility related to program are accounted in an approved determine who all the permitted entities the protection of endangered or ICR (EPA ICR number 0229.23, OMB are at larger projects. The NOI form will threatened species. See Request for control no. 2040–0004). Certain changes also include a proposed new question Comment 3 in Part 1.4.3 of the proposed in this permit require revisions to the that requires the operator to confirm permit. ICR to reflect changes to the forms and that any personnel conducting 4. Stabilization deadlines—Request other information collection inspections at the site will meet the for comment on whether the 5-acre requirements. EPA is reflecting the modified training requirements in Part 6 disturbance threshold for stricter paperwork burden and costs associated of the permit. EPA also proposes stabilization deadlines has the intended with this permit in a separate ICR clarifying edits to better explain the effect of encouraging the phasing of instead of revising the existing ICR for types of documentation that are needed construction disturbances. See Request the entire program for administrative for several of the eligibility criteria and for Comment 4 in Part 2.2.14.a of the reasons. edits to provide links to updated proposed permit. EPA is proposing to collect new available mapping tools to assist 5. Pollution prevention requirements information as part of the 2022 CGP. operators in determining whether any for construction waste—Request for The NOI form was updated from the listed or threatened species are known comment on whether existing pollution 2017 CGP to collect new information to occur in the action area of their control flexibilities such as those that related to the following: Added one new project. apply to building materials and question related to whether operators products in Part 2.3.3.a should be will be discharging construction V. Provisions for Which EPA Is applied to certain types of construction dewatering water during the course of Soliciting Comment wastes. See Request for Comment 5 in their permit coverage; added questions While EPA encourages the public to Part 2.3.3.e of the proposed permit. about whether there are other operators review and comment on all provisions 6. Water quality-based requirements who are also covered by the CGP at the in the proposed permit, EPA has for dewatering discharges—Request for same site and, if so, what their NPDES included in the body of the proposed comment on requiring targeted sampling ID numbers are; added a check box for permit several proposed provisions on of the dewatering discharges from sites the operator to confirm that any which EPA specifically requests discharging to sediment-impaired personnel conducting inspections at the feedback. The following list summarizes waters or waters designated as Tier 2, site will meet the modified training these specific requests for comment, and Tier 2.5 or Tier 3 waters. See Request for requirements in Part 6 of the permit; where they are included in the permit. Comment 6 in Part 3.3 of the proposed and added clarifying edits to better EPA notes that these are only permit. explain the types of documentation that summaries of the requests for comment. 7. Training Requirements—Request are needed for several of the eligibility The Agency recommends that the public for comment on the proposed criteria related to endangered and see the specific wording of each modifications to the site inspection threatened species and edits to provide comment request within the body of the training requirements, specifically on links to updated available mapping permit. Additionally, the request for how EPA can design its own inspection tools to assist operators in determining comment numbers 1, 3, 4, and 5 are not training program and the criteria used to whether any such species are known to accompanied by a proposed change to describe the minimum requirements for occur in the vicinity of their project. the permit, but rather are inviting input third-party training programs. See EPA added one check box for on possible revisions to the CGP. Request for Comment 7 in Part 6.3 of the operators who are submitting an ‘‘NOT’’ 1. Permit coverage clarification— proposed permit. because all construction activities have Request for comment on potentially 8. Photographic documentation of site ended and the site has met all of the modifying the definition of operator to stabilization—Request for comment on requirements for terminating permit specifically include parties that the proposed requirement to take coverage in Part 8.2.1. The check box determine acceptance of work and pay photographs of the stabilized areas of confirms that the operator has attached for work performed. See Request for the site and submit them with the NOT. photographs taken to document Comment 1 in Part 1.1.1 of the proposed See Request for Comment 8 in Part compliance with the final stabilization permit. 8.2.1.a of the proposed permit. requirements pursuant to Part 8.2.1.a. 2. Prohibition of dewatering Respondents/affected entities: discharges from contaminated sites— VI. Paperwork Reduction Act (PRA) Construction operators in the areas Request for comment on whether The information collection activities where EPA is the NPDES permitting additional sites should be prohibited in this permit have been submitted for authority.

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Respondent’s obligation to respond: and new permit obligations; (3) where EPA is the permitting authority, Compliance with the CGP’s information examining whether any underlying cost and the erosion and sediment control collection and reporting requirements is and benefit assumptions need to be proposed provisions increase the level mandatory for CGP operators. updated; (4) examining more broadly of environmental protection for all Estimated number of respondents: how EPA can analyze benefits when affected populations over the 2017 CGP. EPA estimates that for the duration of developing permits; (5) developing more EPA requests comment on this the three-year ICR period approximately robust approaches to assessing preliminary determination and/or any 7,800 operators will obtain coverage uncertainties associated with the modifications that EPA could make to under the 2022 CGP, or 2,600 operators analytic approaches, including how to the proposed permit to address per year. quantitatively assess uncertainties of environmental justice concerns. Frequency of response: Response key assumptions; and (6) developing a X. Executive Order 13175: Consultation frequencies in the 2022 CGP vary from framework to analyze the effect of and Coordination With Indian Tribal once per permit term to quarterly. cooperative federalism. Total estimated burden: EPA EPA expects the incremental cost Governments estimates that the information collection impact on entities that will be covered In compliance with Executive Order burden of the 2022 CGP is 134,059 under the 2022 CGP, including small 13175, EPA consulted with tribal hours per year. Burden is defined at 5 businesses, to be minimal. EPA officials to gain an understanding of CFR 1320.3(b). anticipates the approximate average and, where necessary, to address the Total estimated cost: EPA estimates annual incremental cost increase tribal implications of the proposed that the final information collection cost (compared to the 2017 CGP) will be permit. During this consultation, EPA of the 2022 CGP is $8,195,357 per year. $704 to $714 per permitted project per conducted the following activities: An agency may not conduct or year. A copy of EPA’s incremental cost • August 13, 2020—EPA mailed sponsor, and a person is not required to analysis for the proposed permit, titled notification letters to all tribal leaders, respond to, a collection of information ‘‘Incremental Cost Impact Analysis for initiating consultation and coordination unless it displays a currently valid OMB the Proposed 2022 Construction General on the proposed permit. The control number. The OMB control Permit (CGP),’’ is available in the docket consultation period was from August numbers for EPA’s regulations in 40 (Docket ID No. EPA–HQ–OW–2021– 13, 2020 to October 27, 2020. • CFR are listed in 40 CFR part 9. EPA 0169). September 9, 2020—EPA will respond to ICR-related comments in participated in the National Tribal the final permit. VIII. Executive Order 12866: Water Council monthly conference call Regulatory Planning and Review and and received written comments in VII. Proposed 2022 CGP Incremental Executive Order 13563: Improving response. Cost Analysis and Future Cost-Benefit Regulation and Regulatory Review • September 16, 2020—EPA led an Considerations The proposed permit is not a informational webinar to provide an The cost analysis accompanying this significant regulatory action and was overview of the current CGP and proposed permit monetizes and therefore not submitted to the Office of information regarding the ongoing quantifies certain incremental cost Management and Budget (OMB) for consultation to the National Tribal impacts of the proposed permit changes review. Caucus. A total of 34 tribal as compared to the 2017 CGP. EPA representatives attended. IX. Executive Order 12898: Federal analyzed each change in the proposed EPA received comments providing Actions To Address Environmental 2022 CGP considering the previous input from tribes. These comments are Justice in Minority Populations and permit’s (i.e., the 2017 CGP) described in EPA’s tribal consultation Low-Income Populations requirements. The objective of this summary, which is can be accessed at incremental cost analysis is to show Executive Order (E.O.) 12898 (59 FR https://www.epa.gov/dockets in the where or to what extent the proposed 7629 (February 16, 1994)) establishes docket for this permit (refer to Docket 2022 CGP requirements impose an federal executive policy on No. EPA–HQ–OW–2021–0169). In incremental increase in administrative environmental justice. Its main addition, EPA received comments and compliance costs (such as the cost provision directs federal agencies, to the during the September 16, 2020 to conduct site inspections or to prepare greatest extent practicable and informational webinar and a September compliance reports) on operators in permitted by law, to make 9, 2020 National Tribal Water Council relation to costs that are already environmental justice part of their monthly conference call with EPA staff. accounted for in the 2017 CGP. mission by identifying and addressing, EPA will provide email notification to More broadly, EPA notes that as appropriate, disproportionately high tribes of the proposed permit and invite additional unquantified costs and and adverse human health or those interested to provide the Agency benefits result from this action. In environmental effects of their programs, with comments. EPA also notes that as developing the next CGP (or another policies, and activities on minority part of the finalization of this proposed NPDES general permit, as appropriate), populations and low-income permit, it will complete the Section 401 EPA plans to estimate the broader populations in the United States. certification procedures with all impacts arising from these actions, EPA has preliminarily determined applicable tribes where this permit will including costs and benefits. Estimates that this proposed permit will not have apply (see Appendix B). under consideration may include: (1) disproportionately high and adverse Assessing how costs and benefits are human health or environmental effects XI. Executive Order 13211: Actions attributed between the CGP and on minority or low-income populations That Significantly Affect Energy applicable water quality standards because the requirements in the Supply, Distribution, or Use (including TMDLs) that may be in effect; proposed permit apply equally to all This action is not a ‘‘significant (2) developing a new modeling construction projects that disturb one or energy action’’ because it is not likely to framework to assess how regulated more acres (or are part of a larger have a significant adverse effect on the entities understand and implement common plan of development that supply, distribution or use of energy pollutant controls related to existing disturbs one or more acres) in areas and has not otherwise been designated

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by the Administrator of the Office of Authority: Clean Water Act, 33 U.S.C. 1251 behalf of the requestor, certain Information and Regulatory Affairs as a et seq. information is collected due to IRS significant energy action. Deborah Szaro, requirements. This information is Acting Regional Administrator, EPA Region collected via a form that is submitted by XII. Compliance With the National the requestor and contains the Environmental Policy Act (NEPA) for 1. Javier Laureano, requestor’s name, Social Security the National Pollutant Discharge Number (SSN), address, email address, Director, Water Division, EPA Region 2. Elimination System (NPDES) General spouse’s name, filing status (for tax Permit for Discharges From Carmen Guerrero-Perez, purposes), and children’s names and Construction Activities Director, Caribbean Environmental Protection dates of birth (DOB). Division, EPA Region 2. DATES: Persons wishing to comment on Pursuant to the National Leslie Gillespie-Marthaler, Environmental Policy Act (NEPA) (42 this system of records notice must do so Deputy Director, Water Division, EPA Region by June 11, 2021. New routine uses for U.S.C. 4321–4307h), the Council on 3. this new system of records will be Environmental Quality’s NEPA Jeaneanne Gettle, effective June 11, 2021. regulations (40 CFR part 15), and EPA’s Director, Water Division, EPA Region 4. ADDRESSES: Submit your comments, regulations for implementing NEPA (40 Tera Fong, CFR part 6), EPA has determined that identified by Docket ID No. EPA–HQ– Director, Water Division, EPA Region 5. OMS–2021–0143, by one of the the 2022 reissuance of the CGP is Charles Maguire, eligible for a categorical exclusion following methods: Deputy Director, Water Division, EPA Region Regulations.gov: www.regulations.gov. requiring documentation under 40 CFR 6. Follow the online instructions for 6.204(a)(1)(iv). This category includes Jeffery Robichaud, submitting comments. ‘‘actions involving reissuance of a Director, Water Division, EPA Region 7. Email: [email protected]. NPDES permit for a new source Humberto Garcia, Fax: 202–566–1752. providing the conclusions of the Acting Director, Water Division, EPA Region Mail: OMS Docket, Environmental original NEPA document are still valid, 8. Protection Agency, Mail Code: 2822T, there will be no degradation of the Toma´s Torres, 1200 Pennsylvania Ave. NW, receiving waters, and the permit Director, Water Division, EPA Region 9. Washington, DC 20460. conditions do not change or are more Daniel D. Opalski, Hand Delivery: OMS Docket, EPA/DC, environmentally protective.’’ EPA WJC West Building, Room 3334, 1301 Director, Water Division, EPA Region 10. completed an Environmental Constitution Ave. NW, Washington, DC Assessment/Finding of No Significant [FR Doc. 2021–09961 Filed 5–11–21; 8:45 am] 20460. Such deliveries are only Impact (EA/FONSI) for the 2012 CGP. BILLING CODE 6560–50–P accepted during the Docket’s normal The analysis and conclusions regarding hours of operation, and special the potential environmental impacts, ENVIRONMENTAL PROTECTION arrangements should be made for reasonable alternatives, and potential AGENCY deliveries of boxed information. mitigation included in the EA/FONSI Instructions: Direct your comments to are still valid for the 2022 reissuance of [FRL–10021–56–OCFO] Docket ID No. EPA–HQ–OMS–2021– the CGP because the proposed permit 0143. The EPA policy is that all Privacy Act of 1974; System of conditions are either the same or more comments received will be included in Records environmentally protective. Actions the public docket without change and may be categorically excluded if the AGENCY: Office of the Chief Financial may be made available online at action fits within a category of action Officer, Environmental Protection www.regulations.gov, including any that is eligible for exclusion and the Agency (EPA). personal information provided, unless proposed action does not involve any ACTION: Notice of a new system of the comment includes information extraordinary circumstances. EPA has records. claimed to be Controlled Unclassified reviewed the proposed action and Information (CUI) or other information SUMMARY: determined that the 2022 reissuance of The U.S. Environmental for which disclosure is restricted by the CGP does not involve any Protection Agency’s (EPA) Office of the statute. Do not submit information that Controller is giving notice that it you consider to be CUI or otherwise extraordinary circumstances listed in proposes to create a new system of protected through www.regulations.gov. 6.204(b)(1) through (10). EPA made a records pursuant to the provisions of the The www.regulations.gov website is an similar determination for the 2017 CGP. Privacy Act of 1974. MoveLINQS ‘‘anonymous access’’ system for the Prior to the issuance of the final 2022 Relocation Software was created to EPA, which means the EPA will not CGP, the EPA Responsible Official will assist in the processing of relocation know your identity or contact document the application of the related expenses for government information unless you provide it in the categorical exclusion and will make it employees. Originally published under body of your comment. If you send an available to the public on EPA’s website EPA SORN–29, which also covers EPA email comment directly to the EPA at https://cdxnodengn.epa.gov/cdx- travel, other accounts payable, and without going through enepa-public/action/nepa/search. If accounts receivable files, the EPA www.regulations.gov your email address new information or changes to the proposes this new SORN to transition will be automatically captured and proposed permit involve or relate to at MoveLINQS from its prior location to a included as part of the comment that is least one of the extraordinary separate Microsoft Azure Government placed in the public docket and made circumstances or otherwise indicate that Cloud. The MoveLINQS system available on the internet. If you submit the permit may not meet the criteria for provides the capability to allow external an electronic comment, the EPA categorical exclusion, EPA will prepare relocation customers (EPA employees) recommends that you include your an EA or Environmental Impact to enter and update their own relocation name and other contact information in Statement (EIS). requests. In order to make payments on the body of your comment. If the EPA

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cannot read your comment due to separate FedRAMP Government Cloud automate and streamline the permanent technical difficulties and cannot contact environment (Microsoft Azure) under change of station (PCS) travel cost you for clarification, the EPA may not the Software as a Service (SaaS) management process, eliminating errors be able to consider your comment. platform. The EPA utilizes the and simplifying the enforcement of Electronic files should avoid the use of MoveLINQS application to help manage complex federal policy throughout the special characters, any form of the Federal Employee Relocation Center Agency. General routine uses D, E, F, G, encryption, and be free of any defects or (FERC), where they process employee K, L, and M apply to this system. viruses. For additional information relocation moves for the EPA. Records may also be disclosed: 1. To the about the EPA public docket, visit the Office of Management and Budget, and EPA Docket Center homepage at http:// SYSTEM NAME AND NUMBER: Department of Treasury for paying taxes www.epa.gov/epahome/dockets.htm. MoveLINQS; EPA–87 on relocation expenses; and 2. to Docket: All documents in the docket SECURITY CLASSIFICATION: provide information to contracted are listed in the www.regulations.gov agencies of the EPA for the purposes of Unclassified. index. Although listed in the index, relocation. This information may some information is not publicly SYSTEM LOCATION: contain monthly reports such as taxes available, e.g., CUI or other information 101 Herbert Drive, Boydton, Va. that were paid, invoices and travel for which disclosure is restricted by 23917; Microsoft Azure Government authorizations that were obligated. The statute. Certain other material, such as Cloud (Azure-Va). routine uses below are both related to copyrighted material, will be publicly and compatible with the original available only in hard copy. Publicly SYSTEM MANAGER(S): purpose for which the information was available docket materials are available William E. Wiggins Jr., Branch Chief, collected. The following general routine either electronically in Business Development & Services uses apply to this system (73 FR 2245): www.regulations.gov or in hard copy at Branch (BDSB), EPA’s Federal D. Disclosure to Office of Management the OMS Docket, EPA/DC, WJC West Employee Relocation Center (FERC), and Budget: Information may be Building, Room 3334, 1301 Constitution [email protected], (513) 487– disclosed to the Office of Management Ave. NW, Washington. DC 20460. The 2013, 26 W Martin Luther King Dr., and Budget at any stage in the Public Reading Room is open from 8:30 Cincinnati, OH 45268. legislative coordination and clearance a.m. to 4:30 p.m., Monday through process in connection with private relief Friday excluding legal holidays. The AUTHORITY FOR MAINTENANCE OF THE SYSTEM: legislation as set forth in OMB Circular telephone number for the Public 5 U.S.C. 5753; 5 CFR part 575, subpart No. A–19. Reading Room is (202) 566–1744, and B. E. Disclosure to Congressional Offices: Information may be disclosed to a the telephone number for the OMS PURPOSE(S) OF THE SYSTEM: Docket is (202) 566–1752. congressional office from the record of Out of an abundance of caution for MoveLINQS, is an EPA major an individual in response to an inquiry members of the public and our staff, the information system (MIS). It was from the congressional office made at EPA Docket Center and Reading Room originally published under the EPA–29 the request of the individual. are closed to the public, with limited SORN, which also covers EPA travel, F. Disclosure to Department of Justice: exceptions, to reduce the risk of other accounts payable, and accounts Information may be disclosed to the transmitting COVID–19. Our Docket receivable files. However, the EPA Department of Justice, or in a Center staff will continue to provide proposes to move the MoveLINQS proceeding before a court, adjudicative remote customer service via email, application to a separate Microsoft body, or other administrative body phone, and webform. We encourage the Azure Government Cloud under the before which the Agency is authorized public to submit comments via https:// new SORN EPA–87. The EPA utilizes to appear, when: www.regulations.gov/ or email, as there MoveLINQS to help manage the BDSB 1. The Agency, or any component may be a delay in processing mail and Federal Employee Relocation Center, thereof; faxes. Hand deliveries and couriers may where they process employee relocation 2. Any employee of the Agency in his be received by scheduled appointment moves for the EPA. or her official capacity; 3. Any employee of the Agency in his only. For further information on EPA CATEGORIES OF INDIVIDUALS COVERED BY or her individual capacity where the Docket Center services and the current SYSTEM: Department of Justice or the Agency status, please visit us online at https:// Federal employees and their family have agreed to represent the employee; www.epa.gov/dockets. members who are eligible for move- or FOR FURTHER INFORMATION CONTACT: related reimbursements will be covered. 4. The United States, if the Agency Rhonda Gerdsen, Business Development CATEGORIES OF RECORDS IN THE SYSTEM: determines that litigation is likely to and Services Branch; Gerdsen.Rhonda@ affect the Agency or any of its SSN, name, address, email address, epa.gov; 1–513–487–2028. components, SUPPLEMENTARY INFORMATION: children’s names and DOB, spouse’s Is a party to litigation or has an MoveLINQS Relocation Software is an name, filing status (for tax purposes). interest in such litigation, and the use EPA major information system (MIS) RECORD SOURCE CATEGORIES: of such records by the Department of that was originally published under the The employees are the source of Justice or the Agency is deemed by the EPA–29 SORN, which also covers EPA information. Agency to be relevant and necessary to travel, other accounts payable, and the litigation provided, however, that in accounts receivable files. Relocation ROUTINE USES OF RECORDS MAINTAINED IN THE each case it has been determined that request data was tracked and SYSTEM, INCLUDING CATEGORIES OF USERS AND the disclosure is compatible with the coordinated by an EPA-hosted version PURPOSES OF SUCH USES: purpose for which the records were of the MoveLINQS software. The EPA MoveLINQS is used internally to collected. now proposes this new SORN to reflect maintain and store pertinent employee G. Disclosure to the National a relocation of the MoveLINQS software and relocation expense data. It uses its Archives: Information may be disclosed from an EPA-hosted environment into a features and flexible controls to to the National Archives and Records

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Administration in records management Permission level assignments will allow card). Additional identity verification inspections. users access only to those functions for procedures may be required, as K. Disclosure in Connection With which they are authorized. All records warranted. Requests must meet the Litigation: Information from this system are maintained in secure, access- requirements of EPA regulations that of records may be disclosed in controlled areas or buildings. implement the Privacy Act of 1974, at connection with litigation or settlement 40 CFR part 16. discussions regarding claims by or POLICIES AND PRACTICES FOR RETRIEVAL OF RECORDS: against the Agency, including public CONTESTING RECORDS PROCEDURES: filing with a court, to the extent that Retrieval of computer records is Requests for correction or amendment disclosure of the information is relevant limited to those who have a need to must identify the record to be changed and necessary to the litigation or know. Currently requestors (end users) and the corrective action sought. discussions and except where court do not have access to records using the Complete EPA Privacy Act procedures orders are otherwise required under MoveLINQS system. All users are are described in the EPA’s Privacy Act section (b)(11) of the Privacy Act of required to have appropriate permission regulations at 40 CFR part 16. levels assigned before accessing the 1974, 5 U.S.C. 552a(b)(11). NOTIFICATION PROCEDURE: The two routine uses below (L and M) system. The permission levels are Any individual who wants to know are required by OMB Memorandum M– determined by the type of user. The whether this system of records contains 17–12. MoveLINQS system is the only method L. Disclosure to Persons or Entities in of retrieval. Users input the information a record about him or her, should make Response to an Actual of or Suspected themselves and only authorized users a written request to the EPA Attn: Breach of Personally Identifiable can access. Agency Privacy Officer, MC 2831T, Information: To appropriate agencies, 1200 Pennsylvania Ave. NW, POLICIES AND PRACTICES FOR RETENTION AND Washington, DC 20460, privacy@ entities, and persons when (1) the DISPOSAL OF RECORDS: epa.gov. Agency suspects or has confirmed that MoveLINQS is listed on EPA Records there has been a breach of the system of Control Schedule 0089 under Chief EXEMPTIONS PROMULGATED FOR THE SYSTEM: records, (2) the Agency has determined Financial Officer as Relocation Expense None. that as a result of the suspected or Management System. The disposition is HISTORY: confirmed breach there is a risk of harm to close when no longer needed for to individuals, the Agency (including its current agency business and destroy 67 FR 8255—Posted on February 22, information systems, programs, and immediately after file closure. 2002—The EPA provided notice that it operations), the Federal Government, or proposed to establish a new system of national security; and (3) the disclosure ADMINISTRATIVE, TECHNICAL, AND PHYSICAL records, the EPA Travel, Other Accounts made to such agencies, entities, and SAFEGUARDS: Payable, and Accounts Receivable Files. persons is reasonably necessary to assist Security controls used to protect Vaughn Noga, in connection with the Agency’s efforts personal sensitive data in MoveLINQS to respond to the suspected or are commensurate with those required Senior Agency Official for Privacy. confirmed breach or to prevent, for an information system rated [FR Doc. 2021–10040 Filed 5–11–21; 8:45 am] minimize, or remedy such harm. moderate for confidentiality, integrity, BILLING CODE 6560–50–P M. Disclosure to Assist Another and availability, as prescribed in NIST Agency in Its Efforts to Respond to a Special Publication, 800–53, Breach of Personally Identifiable ‘‘Recommended Security Controls for FEDERAL COMMUNICATIONS Information: To another Federal agency Federal Information Systems,’’ Revision COMMISSION 4. Administrative controls include the or Federal entity, when the Agency [OMB 3060–0874; FRS 25345] determines that information from this policies and procedures governing the system of records is reasonably agency program and systems operated Information Collections Being necessary to assist the recipient agency within, background investigations for Reviewed by the Federal or entity in (1) responding to a privileged users and rules of behavior. Communications Commission suspected or confirmed breach or (2) Technical controls include role-based, preventing, minimizing, or remedying user access controls, and data AGENCY: Federal Communications the risk of harm to individuals, the encryption. All MoveLINQS servers and Commission. recipient agency or entity (including its software are stored in the Microsoft ACTION: Notice and request for information systems, programs, and Azure Va. Datacenter. All security comments. operations), the Federal Government, or measures for the physical space are the SUMMARY: As part of its continuing effort national security, resulting from a responsibility of Microsoft. Microsoft to reduce paperwork burdens, and as suspected or confirmed breach. Azure Government must in addition adhere to FedRAMP regulations and required by the Paperwork Reduction POLICIES AND PRACTICES FOR STORAGE OF policies set forth by the Joint Act of 1995 (PRA), the Federal RECORDS: Authorization Board, which is the Communications Commission (FCC or Records are maintained electronically primary authority and decision-making Commission) invites the general public on computer storage devices such as board that ensures FedRAMP Cloud and other Federal agencies to take this servers and cloud storage. The computer System compliance. opportunity to comment on the storage devices are located at the EPA; following information collection(s). MoveLINQS backups will be maintained RECORD ACCESS PROCEDURES: Comments are requested concerning: at a disaster recovery site designated by Individuals seeking access to Whether the proposed collection of Microsoft Azure Government. Computer information in this system of records information is necessary for the proper records are maintained in a secure about themselves are required to performance of the functions of the password protected environment. provide adequate identification (e.g., Commission, including whether the Access to computer records is limited to driver’s license, military identification information shall have practical utility; those who have a need to know. card, employee badge or identification the accuracy of the Commission’s

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burden estimate; ways to enhance the Dispute Assistance.’’ As required by the other related filings required by the quality, utility, and clarity of the Privacy Act, 5 U.S.C. 552a, the Board, if any, are available for information collected; ways to minimize Commission also published a SORN, immediate inspection at the Federal the burden of the collection of FCC/CGB–1 ‘‘Informal Complaints, Reserve Bank(s) indicated below and at information on the respondents, Inquiries, and Requests for Dispute the offices of the Board of Governors. including the use of automated Assistance,’’ in the Federal Register on This information may also be obtained collection techniques or other forms of August 15, 2014 (79 FR 48152) which on an expedited basis, upon request, by information technology; and ways to became effective on September 24, 2014. contacting the appropriate Federal further reduce the information It may be reviewed at https:// Reserve Bank and from the Board’s collection burden on small business www.fcc.gov/general/privacy-act- Freedom of Information Office at concerns with fewer than 25 employees. information#systems. https://www.federalreserve.gov/foia/ The FCC may not conduct or sponsor a Privacy Impact Assessment: The FCC request.htm. Interested persons may collection of information unless it completed a Privacy Impact Assessment express their views in writing on the displays a currently valid Office of (PIA) on June 28, 2007. It may be standards enumerated in paragraph 7 of Management and Budget (OMB) control reviewed at http://www.fcc.gov/omd/ the Act. number. No person shall be subject to privacyact/Privacy-Impact- Comments regarding each of these any penalty for failing to comply with Assessment.html. applications must be received at the a collection of information subject to the Needs and Uses: The Commission Reserve Bank indicated or the offices of PRA that does not display a valid OMB consolidated all of the FCC informal the Board of Governors, Ann E. control number. consumer complaint intake into an Misback, Secretary of the Board, 20th DATES: Written comments should be online consumer complaint portal, Street and Constitution Avenue NW, submitted on or before July 12, 2021. If which allows the Commission to better Washington, DC 20551–0001, not later you anticipate that you will be manage the collection of informal than May 27, 2021. submitting comments but find it consumer complaints. Informal A. Federal Reserve Bank of Dallas difficult to do so within the period of consumer complaints consist of (Karen Smith, Director, Applications) time allowed by this notice, you should informal consumer complaints, 2200 North Pearl Street, Dallas, Texas advise the contacts below as soon as inquiries and comments. This revised 75201–2272: possible. information collection requests OMB 1. The Trust Department at FirstBank approval for the addition of a layer of Southwest, Amarillo, Texas; to retain ADDRESSES: Direct all PRA comments to consumer reported complaint voting shares of FirstPerryton Bancorp, Cathy Williams, FCC, via email to PRA@ information related to the National Deaf- Inc. (‘‘Company’’), Perryton, Texas, by fcc.gov and to [email protected]. Blind Equipment Distribution Program becoming trustee of the Carl Ellis FOR FURTHER INFORMATION CONTACT: For rules. The information collection Separate Property FPB Stock Revocable additional information about the burdens associated with these Trust, Amarillo, Texas, which owns information collection, contact Cathy complaints is being transferred from Company stock and thereby indirectly Williams at (202) 418–2918. OMB Control Number 3060–1225 owns First Bank Southwest, Perryton, SUPPLEMENTARY INFORMATION: (National Deaf-Blind Equipment Texas. Additionally, the Ellis Family OMB Control Number: 3060–0874. Distribution Program) to OMB Control Trust—Julie Ellis FirstBank Southwest Title: Consumer Complaint Center: Number 3060–0874 to enable consumers Trust S, and the Trust Department at Informal Consumer Complaints. to file complaints related to the National FirstBank Southwest, as trustee, to Form Number: N/A. Deaf-Blind Equipment Distribution acquire voting shares of the Company Type of Review: Revision of a Program rules through the and to join the Ellis Family Group, a currently approved collection. Commission’s Consumer Complaint group acting in concert, all of Amarillo, Respondents: Individuals or Center. Texas. households; Business or other for-profit Federal Communications Commission. Board of Governors of the Federal Reserve entities; Not for profit institutions; State, System, May 7, 2021. Local or Tribal Government. Marlene Dortch, Michele Taylor Fennell, Number of Respondents and Secretary, Office of the Secretary. Deputy Associate Secretary of the Board. Responses: 292,937 respondents; [FR Doc. 2021–10002 Filed 5–11–21; 8:45 am] [FR Doc. 2021–10016 Filed 5–11–21; 8:45 am] 292,937 responses. BILLING CODE 6712–01–P Estimated Time per Response: 15 BILLING CODE P minutes (.25 hour) to 1 hour. Frequency of Response: On occasion FEDERAL RESERVE SYSTEM reporting requirement. DEPARTMENT OF HEALTH AND Obligation to Respond: Voluntary. Change in Bank Control Notices; HUMAN SERVICES The statutory authority for this Acquisitions of Shares of a Bank or Agency for Healthcare Research and collection is contained in 47 U.S.C. 208 Bank Holding Company of the Communications Act of 1934, as Quality amended (the Act). The notificants listed below have Total Annual Burden: 73,244 hours. applied under the Change in Bank Agency Information Collection Total Annual Cost: None. Control Act (Act) (12 U.S.C. 1817(j)) and Activities: Proposed Collection; Nature and Extent of Confidentiality: § 225.41 of the Board’s Regulation Y (12 Comment Request Confidentiality is an issue to the extent CFR 225.41) to acquire shares of a bank AGENCY: Agency for Healthcare Research that individuals and households or bank holding company. The factors and Quality, HHS. provide personally identifiable that are considered in acting on the ACTION: Notice. information, which is covered under the applications are set forth in paragraph 7 FCC’s updated system of records notice of the Act (12 U.S.C. 1817(j)(7)). SUMMARY: This notice announces the (SORN), FCC/CGB–1, ‘‘Informal The public portions of the intention of the Agency for Healthcare Complaints, Inquiries and Requests for applications listed below, as well as Research and Quality (AHRQ) to request

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that the Office of Management and patterns of failures and propose seeking to be listed by the Secretary as Budget (OMB) approve the proposed measures to eliminate or reduce risks a PSO for an initial three-year period. information collection project ‘‘Patient and hazards. 2. PSO Certification for Continued Safety Organization Certification for In order to implement the Patient Listing Form. In accordance with 42 Initial Listing and Related Forms, Safety Act, the Department of Health U.S.C. 299b–24(a)(2) and the above- Patient Safety Confidentiality and Human Services (HHS) issued the cited regulatory certification provisions, Complaint Form, and Common Patient Safety and Quality Improvement this form is to be completed by a listed Formats.’’ Final Rule (Patient Safety Rule, 42 CFR PSO seeking continued listing by the Secretary as a PSO for each successive DATES: Comments on this notice must be part 3) which became effective on three-year period. received by July 12, 2021 January 19, 2009. The Patient Safety Rule outlines the requirements that 3. PSO Two Bona Fide Contracts ADDRESSES: Written comments should entities must meet to become and Requirement Certification Form. To be submitted to: Doris Lefkowitz, remain listed as PSOs, the process by remain listed, a PSO must meet the Reports Clearance Officer, AHRQ, by which the Secretary of HHS (Secretary) requirement in 42 U.S.C. 299b– email at [email protected]. will accept certifications and list PSOs, 24(b)(1)(C) that it has contracts with Copies of the proposed collection more than one provider, within plans, data collection instruments, and and provisions pertaining to the confidentiality and privilege protections successive 24-month periods, beginning specific details on the estimated burden with the date of the PSO’s initial listing. can be obtained from the AHRQ Reports for patient safety work product (PSWP). When specific statutory requirements This form is to be used by a PSO to Clearance Officer. certify whether it has met this statutory are met, the information collected and FOR FURTHER INFORMATION CONTACT: requirement and the corresponding the analyses and deliberations regarding Doris Lefkowitz, AHRQ Reports regulatory provision. the information receive confidentiality Clearance Officer, (301) 427–1477, or by 4. PSO Disclosure Statement Form. and privilege protections under this email at [email protected]. This form provides detailed instructions legislation. The Secretary delegated SUPPLEMENTARY INFORMATION: to a PSO regarding the disclosure authority to the Director of the Office for statement it must submit and provides Proposed Project Civil Rights (OCR) to interpret and for the required certification by the PSO enforce the confidentiality protections ‘‘Patient Safety Organization of the statement’s accuracy in of the Patient Safety Act (Federal accordance with 42 U.S.C. 299b– Certification for Initial Listing and Register, Vol. 71, No. 95, May 17, 2006, Related Forms, Patient Safety 24(b)(1)(E), when it (i) has a contract p. 28701–2). AHRQ implements and with a provider to carry out patient Confidentiality Complaint Form, and administers the rest of the statute’s Common Formats’’ safety activities, and (ii) it has other provisions. financial, reporting, or contractual The Patient Safety and Quality Pursuant to the Patient Safety Rule relationship(s) with that contracting Improvement Act of 2005 (Patient Safety (42 CFR 3.102), an entity that seeks to provider, or it is not managed, Act), signed into law on July 29, 2005, be listed as a PSO by the Secretary must controlled, and operated independently was enacted in response to growing certify that it meets certain requirements from that contracting provider. In concern about patient safety in the and, upon listing, would meet other accordance with the Patient Safety Act United States and the Institute of criteria. To remain listed for renewable and the Patient Safety Rule, the Medicine’s 1999 report, To Err is three-year periods, a PSO must re-certify Secretary is required to review each Human: Building a Safer Health System. that it meets these obligations and such report and make public findings as The goal of the statute is to create a would continue to meet them while to whether a PSO can fairly and national learning system. By providing listed. The Patient Safety Act and accurately carry out its responsibilities. incentives of nation-wide Patient Safety Rule also impose other 5. PSO Profile Form. This form is confidentiality and legal privilege, the obligations discussed below that a PSO designed to collect voluntarily a Patient Safety Act learning system must meet to remain listed. In minimum level of data necessary to improves patient safety and quality by accordance with the requirements of the develop aggregate statistics relating to providing an incentive for health care Patient Safety Rule (see, e.g., 42 CFR PSOs, the types of providers they work providers to work voluntarily with 3.102(a)(1), 3.102(b)(2)(i)(E), 3.102(d)(1), with, and their general location in the experts in patient safety to reduce risks and 3.112), the entities seeking to be US. The PSO Profile is intended to be and hazards to the safety and quality of listed and to remain listed must completed annually by all PSOs that are patient care. The Patient Safety Act complete the proposed forms, in order ‘‘AHRQ-listed’’ during any part of the signifies the Federal Government’s to attest to compliance with statutory previous calendar year. This commitment to fostering a culture of criteria and the corresponding information is collected by AHRQ’s PSO patient safety among health care regulatory requirements. Privacy Protection Center (PSOPPC) and providers; it offers a mechanism for Method of Collection is used to populate the AHRQ PSO creating an environment in which the selection tool on the AHRQ PSO causes of risks and hazards to patient With this submission, AHRQ is website, to generate slides presented at safety can be thoroughly and honestly requesting approval of the following the PSO Annual Meeting, and to examined and discussed without fear of proposed administrative forms: develop content for the AHRQ National penalties and liabilities. It provides for 1. PSO Certification for Initial Listing Healthcare Quality and Disparities the voluntary formation of Patient Form. This form, containing Report, an annual quality report Safety Organizations (PSOs) that can certifications of eligibility and a required by 42 U.S.C. 299b–2(b)(2). collect, aggregate, and analyze capacity and intention to comply with 6. PSO Change of Listing Information confidential information reported statutory criteria and regulatory Form. The Secretary is required under voluntarily by health care providers. By requirements, is to be completed, in 42 U.S.C. 299b–24(d) to maintain a analyzing substantial amounts of patient accordance with 42 U.S.C. 299b–24(a)(1) publicly available list of PSOs. Under safety event information across multiple and the above-cited regulatory the Patient Safety Rule, that list institutions, PSOs are able to identify certification provisions, by an entity includes, among other information, each

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PSO’s current contact information. The privacy of protected health information. Two Bona Fide Contract Certification Patient Safety Rule, at 42 CFR Use of the form is voluntary. It may help Form is based upon an estimate of 51 3.102(a)(1)(vi), also requires that, during a complainant provide the essential respondents per year and an estimated its period of listing, a PSO must information. Alternatively, a one hour per response. This collection promptly notify the Secretary of any complainant may choose to submit a of information takes place once per 24- changes in the accuracy of the complaint in the form of a letter or month period when the PSO notifies the information submitted for listing. electronically. An individual who needs Secretary that it has two contracts with 7. PSO Voluntary Relinquishment help to submit a complaint in writing providers that meet the requirements. Form. A PSO may voluntarily relinquish may call OCR for assistance. PSO Disclosure Statement Form: The average burden for the collection of its status as a PSO for any reason. Estimated Annual Respondent Burden Pursuant to 42 CFR 3.108(c)(2), in order information requested by the Disclosure for the Secretary to accept a PSO’s The PSO information collection forms Statement Form is based upon an notification of voluntary described below will be implemented at estimate of two respondents per year relinquishment, the notice must contain different times and frequencies due to and estimated three hours per response. certain attestations and future contact the voluntary nature of seeking listing This information collection takes place information. This form provides an and remaining listed as a PSO, filing an within 45 days of when a PSO begins efficient manner for a PSO seeking OCR Patient Safety Confidentiality having any of the specified types of voluntary relinquishment to provide all Complaint Form, and using the additional relationships with a provider of the required information. Common Formats. The burden estimates with which it has a contract to carry out OCR is requesting approval of the are based on the average of the form patient safety activities. following administrative form: submissions received over the past three PSO Profile Form. The overall annual years. Patient Safety Confidentiality Complaint burden for the collection of information Exhibit 1 shows the estimated requested by the PSO Profile Form is Form. The purpose of this collection annualized burden hours for the based upon an estimate of 72 is to allow OCR to collect the respondent to provide the requested respondents per year and an estimated minimum information needed from information, and Exhibit 2 shows the three hours per response. The collection individuals filing patient safety estimated annualized cost burden of information takes place annually; confidentiality complaints with OCR associated with the respondents’ time to newly listed PSOs may first submit the so that there is a basis for initial provide the requested information. The form in the calendar year after their processing of those complaints. total burden hours are estimated to be initial listing by the Secretary. In addition, AHRQ is requesting 100,795.83 hours annually and the total PSO Change of Listing Information approval for a set of common definitions cost burden is estimated to be Form: The average annual burden for and reporting formats (Common $4,053,000.33 annually. the collection of information requested Formats). As authorized by 42 U.S.C. PSO Certification for Initial Listing by the PSO Change of Listing 299b–23(b), AHRQ coordinates the Form: The average annual burden for Information Form is based upon an development of the Common Formats the collection of information requested estimate of 54 respondents per year and that facilitate aggregation of comparable by the certification form for initial an estimated time of five minutes per data at local, PSO, regional and national listing is based upon a total average response. This collection of information levels. The Common Formats allow estimate of 10 respondents per year and takes place on an ongoing basis as PSOs and health care providers to an estimated time of 18 hours per needed when there are changes to the voluntarily collect and submit response. The estimated response PSO’s listing information. standardized information regarding number includes submissions by not PSO Voluntary Relinquishment Form: patient safety events to fulfill the only entities listed as PSOs, but also The average annual burden for the national learning system envisioned by entities that submit initial listing forms collection of information requested by the Patient Safety Act. that do not become PSOs. After the PSO Voluntary Relinquishment OMB previously approved the submitting a PSO Certification for Initial Form is based upon a total average Common Formats and forms described Listing Form, an entity may withdraw estimate of four respondents per year above in 2008, 2011, 2014, and 2018. its form or submit a revised form, and an estimated time of thirty minutes AHRQ will use these forms, other than particularly after receiving technical per response. the Patient Safety Confidentiality assistance from AHRQ. In addition, OCR Patient Safety Confidentiality Complaint Form, to obtain information AHRQ, on behalf of the Secretary, may Complaint Form: The overall annual necessary to carry out its authority to deny listing if an entity does not meet burden estimate for the collection of implement the Patient Safety Act and the requirements of the Patient Safety information requested by the OCR Patient Safety Rule. This includes Act and Patient Safety Rule. Patient Safety Confidentiality Complaint obtaining initial and subsequent PSO Certification for Continued Form is based on an estimate of one certifications from entities seeking to be Listing Form: The average annual respondent per year and an estimated or remain listed as PSOs and for making burden for the collection of information twenty minutes per response. The the statutorily required determinations requested by the certification form for voluntary use of the form may occur prior to and during an entity’s period of continued listing has an estimated time when an allegation of a violation of the listing as a PSO. The PSO Division, of eight hours per response and 42 confidentiality protections of the Patient housed in AHRQ’s Center for Quality responses annually. The PSO Safety Act is made. Improvement and Patient Safety, uses Certification for Continued Listing Form Common Formats: AHRQ estimates this information. must be completed by any interested that 5% full time equivalent (FTE) of a OCR will use the Patient Safety PSO at least 75 days before the end of patient safety manager at a facility will Confidentiality Complaint Form to its current three-year listing period. be spent to administer the Common collect information for the initial PSO Two Bona Fide Contracts Formats, which is approximately 100 assessment of an incoming complaint. Requirement Certification Form: The hours a year. The use of the formats by The form is modeled on OCR’s form for average annual burden for the collection PSOs and other entities is voluntary and complaints alleging violations of the of information requested by the PSO is on an ongoing basis. This estimate of

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the 1,000 respondents is based on the during meetings and technical entities that have been utilizing the feedback that AHRQ has received assistance calls from PSOs and other formats.

EXHIBIT 1—ESTIMATED ANNUALIZED BURDEN HOURS

Number of Total Form Number of responses per Hours per burden respondents respondent response hours

PSO Certification for Initial Listing Form ...... 10 1 18 180 PSO Certification for Continued Listing Form ...... 42 1 8 336 PSO Two Bona Fide Contracts Requirement Form ...... 51 1 1 51 PSO Disclosure Statement Form ...... 2 1 3 6 PSO Profile Form ...... 72 1 3 216 PSO Change of Listing Information ...... 54 1 05/60 4.50 PSO Voluntary Relinquishment Form ...... 4 1 30/60 2 OCR Patient Safety Confidentiality Complaint Form ...... 1 1 20/60 .33 Common Formats ...... 1,000 1 100 100,000

Total ...... NA NA 100,795.83

EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN

Total Average Form Number of burden hourly Total cost respondents hours wage rate *

PSO Certification for Initial Listing Form ...... 10 180 $40.21 $7,237.80 PSO Certification for Continued Listing Form ...... 42 336 40.21 13,510.56 PSO Two Bona Fide Contracts Requirement Form ...... 51 51 40.21 2,050.71 PSO Disclosure Statement Form ...... 2 6 40.21 241.26 PSO Profile Form ...... 72 216 40.21 8,685.36 PSO Change of Listing Form ...... 54 4.50 40.21 180.95 PSO Voluntary Relinquishment Form ...... 4 2 40.21 80.42 OCR Patient Safety Confidentiality Complaint Form ...... 1 .33 40.21 13.27 Common Formats ...... 1,000 100,000 40.21 4,021,000.00

Total ...... 4,053,000.33 * Based upon the mean of the hourly average wages for healthcare practitioner and technical occupations, 29–0000, National Compensation Survey, May 2019, ‘‘U.S. Department of Labor, Bureau of Labor Statistics.’’ https://www.bls.gov/oes/current/oes290000.htm.

Request for Comments comments will become a matter of on Outreach and Education (APOE). In accordance with the Paperwork public record. This notice also announces the next Reduction Act, 44 U.S.C. 3501–3521, Dated: May 6, 2021. meeting of the APOE (the Panel) in accordance with the Federal Advisory comments on AHRQ’s information Marquita Cullom, Committee Act. The Panel advises and collection are requested with regard to Associate Director. any of the following: (a) Whether the makes recommendations to the [FR Doc. 2021–09973 Filed 5–11–21; 8:45 am] Secretary of the U.S. Department of proposed collection of information is BILLING CODE 4160–90–P necessary for the proper performance of Health and Human Services (HHS) (the AHRQ’s health care research and health Secretary) and the Administrator of the Centers for Medicare & Medicaid care information dissemination DEPARTMENT OF HEALTH AND Services (CMS) on opportunities to functions, including whether the HUMAN SERVICES information will have practical utility; enhance the effectiveness of consumer education strategies concerning the and, for OCR’s enforcement of Centers for Medicare & Medicaid ® confidentiality; (b) the accuracy of Services Health Insurance Marketplace , AHRQ’s estimate of burden (including Medicare, Medicaid, and the Children’s hours and costs) of the proposed [CMS–7062–N] Health Insurance Program (CHIP). This collection(s) of information; (c) ways to meeting is open to the public. Request for Nominations and enhance the quality, utility and clarity DATES: Announcement of the Advisory Panel of the information to be collected; and Meeting Date: Wednesday, May 26, on Outreach and Education (APOE) (d) ways to minimize the burden of the 2021 from 12:00 p.m. to 5:00 p.m. May 26, 2021 Virtual Meeting collection of information upon the eastern daylight time (e.d.t). respondents, including the use of AGENCY: Centers for Medicare & Deadline for Meeting Registration, automated collection techniques or Medicaid Services (CMS), Health and Presentations, Special other forms of information technology. Human Services (HHS). Accommodations, and Comments: Comments submitted in response to ACTION: Notice. Wednesday, May 19, 2021, 5:00 p.m. this notice will be summarized and (e.d.t). included in the Agency’s subsequent SUMMARY: This notice invites all Deadline for Submitting Nominations: request for OMB approval of the interested parties to submit nominations Nominations will be considered if we proposed information collection. All to fill vacancies on the Advisory Panel receive them at the appropriate address,

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provided in the ADDRESSES section of Panel on Medicare Education 1 (the implement and administer these this notice, no later than 5 p.m., (e.d.t.) predecessor to the APOE) on January 21, changes, we must provide information on June 11, 2021. 1999 (64 FR 7899) to advise and make to consumers, providers, and other ADDRESSES: recommendations to the Secretary and stakeholders through education and Meeting Location: Virtual. All those the Administrator of the Centers for outreach programs regarding how who RSVP will receive the link to Medicare & Medicaid Services (CMS) on existing programs will change and the attend. the effective implementation of national expanded range of health coverage Nominations, Presentations, and Medicare education programs, including options available, including private Written Comments: Nominations, with respect to the Medicare+Choice health insurance coverage through the presentations, and written comments (M+C) program added by the Balanced Marketplace®. The APOE allows us to should be submitted to: Lisa Carr, Budget Act of 1997 (Pub. L. 105–33). consider a broad range of views and Designated Federal Official (DFO), The Medicare Prescription Drug, information from interested audiences Office of Communications, Centers for Improvement, and Modernization Act of in connection with this effort and to Medicare & Medicaid Services, 200 2003 (MMA) (Pub. L. 108–173) identify opportunities to enhance the Independence Avenue SW, Mailstop expanded the existing health plan effectiveness of education strategies 325G HHH, Washington, DC 20201, options and benefits available under the concerning the Affordable Care Act. The 202–690–5742, or via email at APOE@ M+C program and renamed it the scope of this Panel also includes cms.hhs.gov. Medicare Advantage (MA) program. advising on issues pertaining to the Registration: The meeting is open to CMS has had substantial responsibilities education of providers and stakeholders the public, but attendance is limited to to provide information to Medicare with respect to the Affordable Care Act the space available. Persons wishing to beneficiaries about the range of health and certain provisions of the Health attend this meeting must register at the plan options available and better tools Information Technology for Economic website https://www.eventbrite.com/e/ to evaluate these options. Successful and Clinical Health (HITECH) Act apoe-may-26-2021-virtual-meeting- MA program implementation required enacted as part of the American tickets-150209828641 or by contacting CMS to consider the views and policy Recovery and Reinvestment Act of 2009 the DFO listed in the FOR FURTHER input from a variety of private sector (ARRA) (Pub. L. 111–5). INFORMATION CONTACT section of this constituents and to develop a broad On January 21, 2011, the Panel’s notice, by the date listed in the DATES range of public-private partnerships. charter was renewed and the Panel was section of this notice. Individuals In addition, Title I of the MMA renamed the Advisory Panel for requiring sign language interpretation or authorized the Secretary and the Outreach and Education. The Panel’s other special accommodations should Administrator of CMS (by delegation) to charter was most recently renewed on contact the DFO at the address listed in establish the Medicare prescription drug January 19, 2021, and will terminate on the ADDRESSES section of this notice by benefit. The drug benefit allows January 19, 2023 unless renewed by the date listed in the DATES section of beneficiaries to obtain qualified appropriate action. prescription drug coverage. In order to this notice. B. Charter Renewal and Copies of the effectively administer the MA program FOR FURTHER INFORMATION CONTACT: Lisa Charter Carr, Designated Federal Official, Office and the Medicare prescription drug In accordance with the January 19, of Communications, 200 Independence benefit, we have substantial 2021, charter, the APOE will advise the Avenue SW, Mailstop 325G HHH, responsibilities to provide information HHS and CMS on developing and Washington, DC 20201, 202–690–5742, to Medicare beneficiaries about the implementing education programs that or via email at [email protected]. range of health plan options and Additional information about the benefits available, and to develop better support individuals who are enrolled in APOE is available at: https:// tools to evaluate these plans and or eligible for Medicare, Medicaid, benefits. CHIP, or coverage available through the www.cms.gov/Regulations-and- ® Guidance/Guidance/FACA/APOE. Press The Patient Protection and Affordable Health Insurance Marketplace and inquiries are handled through the CMS Care Act (Pub. L. 111–148) and Health other CMS programs. The scope of this Press Office at (202) 690–6145. Care and Education Reconciliation Act FACA group also includes advising on of 2010 (Pub. L. 111–152) (collectively education of providers and stakeholders SUPPLEMENTARY INFORMATION: referred to as the Affordable Care Act) with respect to health care reform and I. Background and Charter Renewal expanded the availability of other certain provisions of the HITECH Act Information options for health care coverage and enacted as part of the ARRA. The charter will terminate on January A. Background enacted a number of changes to Medicare as well as to Medicaid and 19, 2023, unless renewed by appropriate The Advisory Panel for Outreach and CHIP. Qualified individuals and action. The APOE was chartered under Education (APOE) (the Panel) is qualified employers are now able to 42 U.S.C. 217a, section 222 of the Public governed by the provisions of the purchase private health insurance Health Service Act, as amended. The Federal Advisory Committee Act coverage through a competitive APOE is governed by provisions of (FACA) (Pub. L. 92–463), as amended (5 marketplace, called an Affordable Public Law 92–463, as amended (5 U.S.C. Appendix 2), which sets forth Insurance Exchange (also called Health U.S.C. Appendix 2), which sets forth standards for the formation and use of Insurance Marketplace®, or standards for the formation and use of federal advisory committees. The Panel Marketplace® 2). In order to effectively advisory committees. is authorized by section 1114(f) of the In accordance with the renewed Social Security Act (the Act) (42 U.S.C. 1 We note that the Citizen’s Advisory Panel on charter, the APOE will advise the 1314(f)) and section 222 of the Public Medicare Education is also referred to as the Secretary and the CMS Administrator Health Service Act (42 U.S.C. 217a). Advisory Panel on Medicare Education (65 FR concerning optimal strategies for the The Secretary of the U.S. Department 4617). The name was updated in the Second following: Amended Charter approved on July 24, 2000. • of Health and Human Services (HHS) 2 Health Insurance Marketplace®SM and Developing and implementing (the Secretary) signed the charter Marketplace®SM are service marks of the U.S. education and outreach programs for establishing the Citizen’s Advisory Department of Health and Human Services. individuals enrolled in, or eligible for,

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Medicare, Medicaid, the CHIP, and Michael Minor, National Director, members of all racial and ethnic groups, coverage available through the Health H.O.P.E. HHS Partnership, National and disabled individuals are adequately Insurance Marketplace® and other CMS Baptist Convention USA, Incorporated; represented on the APOE. Therefore, we programs. Jina Ragland, Associate State Director of encourage nominations of qualified • Enhancing the federal government’s Advocacy and Outreach, AARP candidates who can represent these effectiveness in informing Medicare, Nebraska; Morgan Reed, Executive interests. Any interested organization or Medicaid, CHIP, or the Health Insurance Director, Association for Competitive person may nominate one or more Marketplace® consumers, issuers, Technology; Margot Savoy, Chair, qualified persons. providers, and stakeholders, pursuant to Department of Family and Community Each nomination must include a letter education and outreach programs of Medicine, Temple University stating that the nominee has expressed issues regarding these programs, Physicians; Congresswoman Allyson a willingness to serve as a Panel including the appropriate use of public- Schwartz, President and CEO, Better member and must be accompanied by a private partnerships to leverage the Medicare Alliance; and; Tia Whitaker, curricula vitae and a brief biographical resources of the private sector in Statewide Director, Outreach and summary of the nominee’s experience. educating beneficiaries, providers, Enrollment, Pennsylvania Association While we are looking for experts in a partners and stakeholders. of Community Health Centers. number of fields, our most specific • Expanding outreach to vulnerable The Secretary’s Charter for the APOE needs are for experts in outreach to and underserved communities, is available on the CMS website at: minority and underserved communities, including racial and ethnic minorities, https://www.facadatabase.gov/FACA/ health communications, disease-related in the context of Medicare, Medicaid, apex/FACAPublicCommittee advocacy, disability policy and access, the CHIP and the Health Insurance ® ?id=a10t0000001gzsCAAQ, or you may health economics research, behavioral Marketplace education programs, and obtain a copy of the charter by health, health insurers and plans, other CMS programs as designated. submitting a request to the contact listed Health IT, social media, direct patient • Assembling and sharing an in the FOR FURTHER INFORMATION section care, and matters of labor and information base of ‘‘best practices’’ for of this notice. retirement. helping consumers evaluate health We are requesting that all submitted coverage options. II. Request for Nominations • curricula vitae include the following: Building and leveraging existing The APOE shall consist of no more • community infrastructures for Date of birth than 20 members. The Chair shall either • Place of birth information, counseling, and assistance. be appointed from among the 20 • • Drawing the program link between Title and current position members, or a Federal official will be • outreach and education, promoting Professional affiliation designated to serve as the Chair. The • consumer understanding of health care Home and business address • coverage choices, and facilitating charter requires that meetings shall be Telephone and fax numbers held up to four times per year. Members • Email address consumer selection/enrollment, which • in turn support the overarching goal of will be expected to attend all meetings. Areas of expertise improved access to quality care, The members and the Chair shall be Phone interviews of nominees may also including prevention services, selected from authorities knowledgeable be requested after review of the envisioned under the Affordable Care in one or more of the following fields: nominations. Act. • Senior citizen advocacy In order to permit an evaluation of The current members of the Panel as • Outreach to minority and underserved possible sources of conflict of interest, of April 9, 2021, are: E. Lorraine Bell, communities potential candidates will be asked to Chief Officer, Population Health, • Health communications provide detailed information concerning Catholic Charities USA; Nazleen • Disease-related advocacy such matters as financial holdings, Bharmal, Medical Director of • Disability policy and access consultancies, and research grants or Community Partnerships, Cleveland • Health economics research contracts. Clinic; Julie Carter, Senior Federal • Health insurers and plans Members are invited to serve for 2- Policy Associate, Medicare Rights • Health IT year terms, contingent upon the renewal Center; Scott Ferguson, Director of Care • Direct patient care of the APOE by appropriate action prior Transitions and Population Health, • Matters of labor and retirement to its termination. A member may serve Mount Sinai St. Luke’s Hospital; Leslie Representatives of the general public after the expiration of that member’s Fried, Senior Director, Center for may also serve on the APOE. term until a successor takes office. Any Benefits Access, National Council on This notice also requests nominations member appointed to fill a vacancy for Aging; Jean-Venable Robertson Goode, for three individuals to serve on the an unexpired term shall be appointed Professor, Department of APOE to fill current vacancies and for the remainder of that term. Pharmacotherapy and Outcomes possible vacancies that may become III. Meeting Format and Agenda Science, School of Pharmacy, Virginia available later in 2021. This notice is an Commonwealth University; Ted invitation to interested organizations or In accordance with section 10(a) of Henson, Director of Health Center individuals to submit their nominations the FACA, this notice announces a Performance and Innovation, National for membership (no self-nominations meeting of the APOE. The agenda for Association of Community Health will be accepted). The CMS the May 26, 2021 meeting will include Centers; Joan Ilardo, Director of Administrator will appoint new the following: Research Initiatives, Michigan State members to the APOE from among those • Welcome and listening session with University, College of Human Medicine; candidates determined to have the CMS leadership Cheri Lattimer, Executive Director, expertise required to meet specific • Recap of the previous (March 31, National Transitions of Care Coalition; agency needs, and in a manner to ensure 2021) meeting Cori McMahon, Vice President, an appropriate balance of membership. • CMS programs, initiatives, and Tridiuum; Alan Meade, Director of We have an interest in ensuring that the priorities Rehab Services, Holston Medical group; interests of both women and men, • An opportunity for public comment

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• Meeting summary, review of DEPARTMENT OF HEALTH AND minimize the information collection recommendations, and next steps HUMAN SERVICES burden. DATES: Comments must be received by Individuals or organizations that wish Centers for Medicare & Medicaid May 26, 2021. to make a 5-minute oral presentation on Services ADDRESSES: an agenda topic should submit a written When commenting, please reference the applicable form number copy of the oral presentation to the DFO [Document Identifier: CMS–10398 #37] (see below) and the OMB control at the address listed in the ADDRESSES number (0938–1148). To be assured section of this notice by the date listed Medicaid and Children’s Health consideration, comments and in the DATES section of this notice. The Insurance Program (CHIP) Generic recommendations must be submitted in number of oral presentations may be Information Collection Activities: any one of the following ways: limited by the time available. Proposed Collection; Comment 1. Electronically. You may send your Individuals not wishing to make an oral Request comments electronically to http:// presentation may submit written www.regulations.gov. Follow the comments to the DFO at the address AGENCY: Centers for Medicare & instructions for ‘‘Comment or listed in the ADDRESSES section of this Medicaid Services, Health and Human Submission’’ or ‘‘More Search Options’’ notice by the date listed in the DATES Services (HHS). to find the information collection section of this notice. ACTION: Notice. document(s) that are accepting comments. IV. Meeting Participation 2. By regular mail. You may mail SUMMARY: On May 28, 2010, the Office written comments to the following The meeting is open to the public, but of Management and Budget (OMB) address: CMS, Office of Strategic attendance is limited to registered issued Paperwork Reduction Act (PRA) Operations and Regulatory Affairs, participants. Persons wishing to attend guidance 1 related to the ‘‘generic’’ Division of Regulations Development, this meeting must register at the website clearance process. Generally, this is an Attention: CMS–10398 (#37)/OMB https://www.eventbrite.com/e/apoe- expedited process by which agencies control number: 0938–1148, Room C4– may obtain OMB’s approval of may-26-2021-virtual-meeting-tickets- 26–05, 7500 Security Boulevard, collection of information requests that 150209828641 or contact the DFO at the Baltimore, Maryland 21244–1850. are ‘‘usually voluntary, low-burden, and address or number listed in the FOR To obtain copies of a supporting uncontroversial collections,’’ do not FURTHER INFORMATION CONTACT section of statement and any related forms for the raise any substantive or policy issues, this notice by the date specified in the proposed collection(s) summarized in and do not require policy or DATES section of this notice. This this notice, you may access CMS’ methodological review. The process meeting will be held virtually. website at https://www.cms.gov/ requires the submission of an Individuals who are not registered in Regulations-and-Guidance/Legislation/ overarching plan that defines the scope advance will be unable to attend the PaperworkReductionActof1995/PRA- of the individual collections that would meeting. Listing.html. fall under its umbrella. On October 23, V. Collection of Information 2011, OMB approved our initial request FOR FURTHER INFORMATION CONTACT: to use the generic clearance process William N. Parham at (410) 786–4669. This document does not impose under control number 0938–1148 SUPPLEMENTARY INFORMATION: Following information collection requirements, (CMS–10398). It was last approved on is a summary of the use and burden that is, reporting, recordkeeping, or April 26, 2021, via the standard PRA associated with the subject information third-party disclosure requirements. process which included the publication collection(s). More detailed information Consequently, there is no need for of 60- and 30-day Federal Register can be found in the collection’s review by the Office of Management and notices. The scope of the April 2021 supporting statement and associated Budget under the authority of the umbrella accounts for Medicaid and materials (see ADDRESSES). Paperwork Reduction Act of 1995 (44 CHIP State plan amendments, waivers, Generic Information Collection U.S.C. chapter 35). demonstrations, and reporting. This 1. Title of Information Collection: The Acting Administrator of the Federal Register notice seeks public comment on one or more of our Medicaid Managed Care Rate Centers for Medicare & Medicaid collection of information requests that Development Guide; Type of Services (CMS), Elizabeth Richter, we believe are generic and fall within Information Collection Request: having reviewed and approved this the scope of the umbrella. Interested Revision of a currently approved document, authorizes Lynette Wilson, persons are invited to submit comments collection; Use: States are required to who is the Federal Register Liaison, to regarding our burden estimates or any submit rate certifications for all electronically sign this document for other aspect of this collection of Medicaid managed care capitation rates purposes of publication in the Federal information, including: The necessity per 42 CFR 438.7. Our collection of Register. and utility of the proposed information information request specifies our Dated: May 10, 2021. collection for the proper performance of requirements for the rate certification and details what types of Lynette Wilson, the agency’s functions, the accuracy of the estimated burden, ways to enhance documentation we expect to be Federal Register Liaison, Centers for Medicare included. Elements include descriptions & Medicaid Services. the quality, utility and clarity of the information to be collected, and the use of data used, projected benefit and non- [FR Doc. 2021–10118 Filed 5–11–21; 8:45 am] of automated collection techniques or benefit costs, rate range development, BILLING CODE 4120–01–P other forms of information technology to risk and contract provisions, and other considerations in all rate setting 1 https://www.whitehouse.gov/sites/ packages. We also detail our whitehouse.gov/files/omb/assets/inforeg/PRA_Gen_ expectations for states when they ICRs_5-28-2010.pdf. submit rate certifications.

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Section 1903(m) of the Social Security finalizes the draft guidance of the same a.m. and 4 p.m., Monday through Act requires capitation rates paid to title issued on May 31, 2018. Friday, 240–402–7500. • Medicaid managed care organizations DATES: The announcement of the Confidential Submissions—To (MCOs) to be actuarially sound. guidance is published in the Federal submit a comment with confidential Regulations at § 438.4 require all Register on May 12, 2021. information that you do not wish to be capitation rates paid to an MCO, made publicly available, submit your ADDRESSES: You may submit either Prepaid Inpatient Health Plan (PIHP), or comments only as a written/paper electronic or written comments on Prepaid Ambulatory Health Plans submission. You should submit two Agency guidances at any time as (PAHP) to be actuarially sound and copies total. One copy will include the follows: require that each state submit a rate information you claim to be confidential certification for each set of capitation Electronic Submissions with a heading or cover note that states ‘‘THIS DOCUMENT CONTAINS rates developed. Regulations at Submit electronic comments in the CONFIDENTIAL INFORMATION.’’ The § 438.7(e) also require that CMS following way: Agency will review this copy, including annually publish this guidance; Form • Federal eRulemaking Portal: the claimed confidential information, in Number: CMS–10398 (#37) (OMB https://www.regulations.gov. Follow the its consideration of comments. The control number: 0938–1148); Frequency: instructions for submitting comments. Occasionally; Affected Public: State, second copy, which will have the Comments submitted electronically, Local, or Tribal Governments; Number claimed confidential information including attachments, to https:// of Respondents: 46; Total Annual redacted/blacked out, will be available www.regulations.gov will be posted to Responses: 135; Total Annual Hours: for public viewing and posted on the docket unchanged. Because your 608. (For policy questions regarding this https://www.regulations.gov. Submit comment will be made public, you are collection contact Amy Gentile at 410– both copies to the Dockets Management solely responsible for ensuring that your 786–3499.) Staff. If you do not wish your name and comment does not include any Dated: May 7, 2021. contact information to be made publicly confidential information that you or a available, you can provide this William N. Parham, III, third party may not wish to be posted, information on the cover sheet and not Director, Paperwork Reduction Staff, Office such as medical information, your or in the body of your comments and you of Strategic Operations and Regulatory anyone else’s Social Security number, or Affairs. must identify this information as confidential business information, such ‘‘confidential.’’ Any information marked [FR Doc. 2021–10050 Filed 5–11–21; 8:45 am] as a manufacturing process. Please note as ‘‘confidential’’ will not be disclosed BILLING CODE 4120–01–P that if you include your name, contact except in accordance with 21 CFR 10.20 information, or other information that and other applicable disclosure law. For identifies you in the body of your more information about FDA’s posting DEPARTMENT OF HEALTH AND comments, that information will be HUMAN SERVICES of comments to public dockets, see 80 posted on https://www.regulations.gov. FR 56469, September 18, 2015, or access • Food and Drug Administration If you want to submit a comment the information at: https:// with confidential information that you www.govinfo.gov/content/pkg/FR-2015- [Docket No. FDA–2018–D–1609] do not wish to be made available to the 09-18/pdf/2015-23389.pdf. public, submit the comment as a Docket: For access to the docket to Q12 Technical and Regulatory written/paper submission and in the read background documents or the Considerations for Pharmaceutical manner detailed (see ‘‘Written/Paper electronic and written/paper comments Product Lifecycle Management; Submissions’’ and ‘‘Instructions’’). received, go to https:// International Council for www.regulations.gov and insert the Harmonisation; Guidance for Industry; Written/Paper Submissions docket number, found in brackets in the Availability Submit written/paper submissions as heading of this document, into the AGENCY: Food and Drug Administration, follows: ‘‘Search’’ box and follow the prompts • HHS. Mail/Hand Delivery/Courier (for and/or go to the Dockets Management ACTION: Notice of availability. written/paper submissions): Dockets Staff, 5630 Fishers Lane, Rm. 1061, Management Staff (HFA–305), Food and Rockville, MD 20852, 240–402–7500. SUMMARY: The Food and Drug Drug Administration, 5630 Fishers You may submit comments on any Administration (FDA or Agency) is Lane, Rm. 1061, Rockville, MD 20852. guidance at any time (see 21 CFR announcing the availability of a final • For written/paper comments 10.115(g)(5)). guidance for industry entitled ‘‘Q12 submitted to the Dockets Management Submit written requests for single Technical and Regulatory Staff, FDA will post your comment, as copies of this guidance to the Division Considerations for Pharmaceutical well as any attachments, except for of Drug Information, Center for Drug Product Lifecycle Management.’’ The information submitted, marked and Evaluation and Research, Food and guidance was prepared under the identified, as confidential, if submitted Drug Administration, 10001 New auspices of the International Council for as detailed in ‘‘Instructions.’’ Hampshire Ave., Hillandale Building, Harmonisation (ICH), formerly the Instructions: All submissions received 4th Floor, Silver Spring, MD 20993– International Conference on must include the Docket No. FDA– 0002, or the Office of Communication, Harmonisation. The guidance, which 2018–D–1609 for ‘‘Q12 Technical and Outreach and Development, Center for consists of a Guidance and Annexes, Regulatory Considerations for Biologics Evaluation and Research provides a framework to facilitate the Pharmaceutical Product Lifecycle (CBER), Food and Drug Administration, management of postapproval chemistry, Management.’’ Received comments will 10903 New Hampshire Ave., Bldg. 71, manufacturing, and controls changes for be placed in the docket and, except for Rm. 3128, Silver Spring, MD 20993– new and marketed pharmaceutical drug those submitted as ‘‘Confidential 0002. Send one self-addressed adhesive substances and drug products, including Submissions,’’ publicly viewable at label to assist that office in processing chemical and biotechnological/ https://www.regulations.gov or at the your requests. The guidance may also be biological products. This guidance Dockets Management Staff between 9 obtained by mail by calling CBER at 1–

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800–835–4709 or 240–402–8010. See industry parties in detailed technical enablers, along with associated guiding the SUPPLEMENTARY INFORMATION section harmonization work and the application principles, that are intended to enhance for electronic access to the guidance of a science-based approach to the management of postapproval document. harmonization through a consensus- changes and transparency between FOR FURTHER INFORMATION CONTACT: driven process that results in the industry and regulatory authorities, Regarding the guidance: Mahesh development of ICH guidelines. The encouraging innovation and continual Ramanadham, Center for Drug regulators around the world are improvement. The guidance is intended Evaluation and Research, Food and committed to consistently adopting to demonstrate how increased product Drug Administration, 10903 New these consensus-based guidelines, and process knowledge can contribute Hampshire Ave., Silver Spring, MD realizing the benefits for patients and for to a more precise and accurate industry. understanding of which postapproval 20993–0002, 301–796–3272; or Stephen As a Founding Regulatory Member of changes require a regulatory submission Ripley, Center for Biologics Evaluation ICH, FDA plays a major role in the as well as the definition of the level of and Research, Food and Drug development of each of the ICH reporting categories for such changes Administration, 10903 New Hampshire guidelines, which FDA then adopts and (i.e., a better understanding of risk to Ave., Bldg. 71, Rm. 7301, Silver Spring, issues as guidance for industry. FDA’s product quality). Increased knowledge MD 20993–0002, 240–402–7911. guidance documents do not establish and effective implementation of the Regarding the ICH: Jill Adleberg, legally enforceable responsibilities. tools and enablers described in this Center for Drug Evaluation and Instead, they describe the Agency’s guidance should enhance industry’s Research, Food and Drug current thinking on a topic and should ability to manage many chemistry, Administration, 10903 New Hampshire be viewed only as recommendations, manufacturing, and controls changes Ave., Bldg. 51, Rm. 6364, Silver Spring, unless specific regulatory or statutory effectively under the company’s MD 20993–0002, 301–796–5259. requirements are cited. Pharmaceutical Quality System (PQS) SUPPLEMENTARY INFORMATION: In the Federal Register of May 31, with less need for extensive regulatory I. Background 2018 (83 FR 25018), FDA published a oversight prior to implementation. This notice announcing the availability of a approach can incentivize continual FDA is announcing the availability of draft guidance entitled ‘‘Q12 Technical improvement by providing an a guidance for industry entitled ‘‘Q12 and Regulatory Considerations for opportunity for greater flexibility in Technical and Regulatory Pharmaceutical Product Lifecycle making postapproval changes. It could Considerations for Pharmaceutical Management.’’ The notice gave also result in fewer associated Product Lifecycle Management.’’ The interested persons an opportunity to postapproval submissions to the guidance was prepared under the submit comments by December 15, Marketing Authorization Application auspices of ICH. ICH has the mission of 2018. and less associated regulatory burden. achieving greater regulatory After consideration of the comments The extent of operational and regulatory harmonization worldwide to ensure that received and revisions to the guideline, flexibility and its adequate safe, effective, high-quality medicines a final draft of the guideline was implementation is subject to the are developed, registered, and submitted to the ICH Assembly and regulatory framework in place as well as maintained in the most resource- endorsed by the regulatory agencies in product and process understanding (ICH efficient manner. November 2019. Changes from the draft Q8(R2) and Q11), application of risk By harmonizing the regulatory to the final guideline include: revision management principles (ICH Q9), and requirements in regions around the of the text regarding the compatibility of an effective PQS (ICH Q10). world, ICH guidelines have the guideline with regional legal This guidance is being issued substantially reduced duplicative frameworks, removal of the terms consistent with FDA’s good guidance clinical studies, prevented unnecessary ‘‘implicit’’ and ‘‘explicit’’ as they practices regulation (21 CFR 10.115). animal studies, standardized the referred to established conditions, The guidance represents the current reporting of important safety removal of the term ‘‘key process thinking of FDA on ‘‘Q12 Technical and information, standardized marketing parameter,’’ and revisions to the text to Regulatory Considerations for application submissions, and made better explain the concept of critical Pharmaceutical Product Lifecycle many other improvements in the quality process parameter and identification of Management.’’ It does not establish any of global drug development and established conditions for rights for any person and is not binding manufacturing and the products manufacturing processes. Other changes on FDA or the public. You can use an available to patients. included revision of the description for alternative approach if it satisfies the The six Founding Members of the ICH identification of established conditions requirements of the applicable statutes are FDA; the Pharmaceutical Research for analytical methods and development and regulations. and Manufacturers of America; the of an illustrative example, revisions to European Commission; the European the recommended content of the II. Paperwork Reduction Act of 1995 Federation of Pharmaceutical Industries product lifecycle management This guidance contains no collection Associations; the Japanese Ministry of document and its location within the of information. Therefore, clearance by Health, Labour, and Welfare; and the common technical document, and the Office of Management and Budget Japanese Pharmaceutical Manufacturers revisions to clarify the use of tools (OMB) under the Paperwork Reduction Association. The Standing Members of described in the guideline for master Act of 1995 (PRA) (44 U.S.C. 3501– the ICH Association include Health files. In addition, editorial changes were 3521) is not required. Canada and Swissmedic. Additionally, made to improve clarity. However, this guidance refers to the Membership of ICH has expanded to The guidance provides guidance on previously approved FDA collections of include other regulatory authorities and postapproval chemistry, manufacturing, information. These collections of industry associations from around the and controls changes for new and information are subject to review by world (refer to https://www.ich.org/). marketed pharmaceutical drug OMB under the PRA. The collections of ICH works by involving technical substances and drug products. The information in 21 CFR part 314 have experts from both regulators and guidance describes regulatory tools and been approved under OMB control

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number 0910–0001 and in part 601 instructions for submitting comments. claimed confidential information under OMB control number 0910–0338. Comments submitted electronically, redacted/blacked out, will be available including attachments, to https:// for public viewing and posted on III. Electronic Access www.regulations.gov will be posted to https://www.regulations.gov. Submit Persons with access to the internet the docket unchanged. Because your both copies to the Dockets Management may obtain the guidance at https:// comment will be made public, you are Staff. If you do not wish your name and www.regulations.gov, https:// solely responsible for ensuring that your contact information to be made publicly www.fda.gov/drugs/guidance- comment does not include any available, you can provide this compliance-regulatory-information/ confidential information that you or a information on the cover sheet and not guidances-drugs, or https:// third party may not wish to be posted, in the body of your comments and you www.fda.gov/vaccines-blood-biologics/ such as medical information, your or must identify this information as guidance-compliance-regulatory- anyone else’s Social Security number, or ‘‘confidential.’’ Any information marked information-biologics/biologics- confidential business information, such as ‘‘confidential’’ will not be disclosed guidances. as a manufacturing process. Please note except in accordance with 21 CFR 10.20 Dated: May 6, 2021. that if you include your name, contact and other applicable disclosure law. For information, or other information that Lauren K. Roth, more information about FDA’s posting identifies you in the body of your of comments to public dockets, see 80 Acting Principal Associate Commissioner for comments, that information will be Policy. FR 56469, September 18, 2015, or access posted on https://www.regulations.gov. the information at: https:// [FR Doc. 2021–09963 Filed 5–11–21; 8:45 am] • If you want to submit a comment www.govinfo.gov/content/pkg/FR-2015- BILLING CODE 4164–01–P with confidential information that you 09-18/pdf/2015-23389.pdf. do not wish to be made available to the Docket: For access to the docket to public, submit the comment as a read background documents or the DEPARTMENT OF HEALTH AND written/paper submission and in the HUMAN SERVICES electronic and written/paper comments manner detailed (see ‘‘Written/Paper received, go to https:// Food and Drug Administration Submissions’’ and ‘‘Instructions’’). www.regulations.gov and insert the Written/Paper Submissions docket number, found in brackets in the [Docket No. FDA–2017–D–7001] heading of this document, into the Submit written/paper submissions as Qualified Infectious Disease Product ‘‘Search’’ box and follow the prompts follows: and/or go to the Dockets Management Designation—Questions and Answers; • Mail/Hand Delivery/Courier (for Staff, 5630 Fishers Lane, Rm. 1061, Guidance for Industry; Availability written/paper submissions): Dockets Rockville, MD 20852, 240–402–7500. Management Staff (HFA–305), Food and AGENCY: Food and Drug Administration, You may submit comments on any Drug Administration, 5630 Fishers HHS. guidance at any time (see 21 CFR Lane, Rm. 1061, Rockville, MD 20852. 10.115(g)(5)). ACTION: Notice of availability. • For written/paper comments Submit written requests for single submitted to the Dockets Management SUMMARY: The Food and Drug copies of the guidance to the Division of Staff, FDA will post your comment, as Administration (FDA or Agency) is Drug Information, Center for Drug well as any attachments, except for announcing the availability of a final Evaluation and Research, Food and information submitted, marked and guidance for industry entitled Drug Administration, 10001 New identified, as confidential, if submitted ‘‘Qualified Infectious Disease Product Hampshire Ave., Hillandale Building, as detailed in ‘‘Instructions.’’ Designation—Questions and Answers.’’ Instructions: All submissions received 4th Floor, Silver Spring, MD 20993– The Food and Drug Administration must include the Docket No. FDA– 0002. Send one self-addressed adhesive Safety and Innovation Act (FDASIA) 2017–D–7001 for ‘‘Qualified Infectious label to assist that office in processing SUPPLEMENTARY created incentives for the development Disease Product Designation—Questions your requests. See the of antibacterial and antifungal drug and Answers.’’ Received comments will INFORMATION section for electronic products that treat serious or life- be placed in the docket and, except for access to the guidance document. threatening infections. The purpose of those submitted as ‘‘Confidential FOR FURTHER INFORMATION CONTACT: this final guidance is to provide a Submissions,’’ publicly viewable at Katherine Schumann, Center for Drug resource for information on FDA’s https://www.regulations.gov or at the Evaluation and Research, Food and policies and procedures related to the Dockets Management Staff between 9 Drug Administration, 10903 New designation of a qualified infectious a.m. and 4 p.m., Monday through Hampshire Ave., Bldg. 22, Rm. 6242, disease product (QIDP). This guidance Friday, 240–402–7500. Silver Spring, MD 20993–0002, 301– finalizes the draft guidance of the same • Confidential Submissions—To 796–1182, Katherine.Schumann@ name issued on January 30, 2018. submit a comment with confidential fda.hhs.gov. DATES: The announcement of the information that you do not wish to be SUPPLEMENTARY INFORMATION: guidance is published in the Federal made publicly available, submit your Register on May 12, 2021. comments only as a written/paper I. Background ADDRESSES: You may submit either submission. You should submit two FDA is announcing the availability of electronic or written comments on copies total. One copy will include the a final guidance for industry entitled Agency guidances at any time as information you claim to be confidential ‘‘Qualified Infectious Disease Product follows: with a heading or cover note that states Designation—Questions and Answers.’’ ‘‘THIS DOCUMENT CONTAINS Title VIII of FDASIA created the Electronic Submissions CONFIDENTIAL INFORMATION.’’ The Generating Antibiotic Incentives Now Submit electronic comments in the Agency will review this copy, including (GAIN) provisions under section 505E of following way: the claimed confidential information, in the Federal Food, Drug, and Cosmetic • Federal eRulemaking Portal: its consideration of comments. The Act (FD&C Act) (21 U.S.C. 355f). GAIN https://www.regulations.gov. Follow the second copy, which will have the offers incentives for the development of

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antibacterial and antifungal drugs for The previously approved collections of collection by selecting ‘‘Currently under human use to treat serious or life- information are subject to review by Review—Open for Public Comments’’ or threatening infections. The primary OMB under the PRA. The collections of by using the search function. The OMB incentive contained in GAIN is a 5-year information in 21 CFR part 312 have control number for this information extension of exclusivity for which a been approved under OMB control collection is 0910–0275. Also include QIDP-designated application qualifies number 0910–0014. the FDA docket number found in upon approval under the FD&C Act. brackets in the heading of this III. Electronic Access QIDPs also receive fast-track designation document. at the sponsor’s request (21 U.S.C. Persons with access to the internet 356(b)(1)), and the first marketing may obtain the guidance at either FOR FURTHER INFORMATION CONTACT: Ila application submitted for approval of a https://www.fda.gov/drugs/guidance- S. Mizrachi, Office of Operations, Food QIDP is granted priority review (21 compliance-regulatory-information/ and Drug Administration, Three White U.S.C. 360n–1). guidances-drugs or https:// Flint North, 10A–12M, 11601 This guidance provides information www.regulations.gov. Landsdown St., North Bethesda, MD 20852, 301–796–7726, PRAStaff@ about how FDA generally intends to Dated: May 5, 2021. implement GAIN and responses to fda.hhs.gov. Lauren K. Roth, common questions that might arise SUPPLEMENTARY INFORMATION: In about QIDP designation and review of Acting Principal Associate Commissioner for Policy. compliance with 44 U.S.C. 3507, FDA new drug applications for QIDPs. has submitted the following proposed This guidance finalizes the draft [FR Doc. 2021–09986 Filed 5–11–21; 8:45 am] collection of information to OMB for guidance of the same name issued on BILLING CODE 4164–01–P review and clearance. January 30, 2018 (83 FR 4216). Based on the comments submitted to the docket State Enforcement Notifications—21 on the draft guidance, FDA made DEPARTMENT OF HEALTH AND CFR 100.2(d) clarifying changes to this guidance, HUMAN SERVICES OMB Control Number 0910–0275— including further information on what Food and Drug Administration drug products the Agency generally Extension intends to consider to be an [Docket No. FDA–2018–N–0074] This information collection supports antibacterial or antifungal drug for the Agency regulations. Specifically, section Agency Information Collection purposes of QIDP designation. The 310(b) of the Federal Food, Drug, and Activities; Submission for Office of Agency also provided clarification about Cosmetic Act (FD&C Act) (21 U.S.C. Management and Budget Review; when a sponsor should submit a new 337(b)) authorizes a State to enforce Comment Request; State Enforcement request for QIDP designation and what certain sections of the FD&C Act in its Notifications information should be included in a own name and within its own QIDP designation request. AGENCY: Food and Drug Administration, jurisdiction. However, before doing so, This guidance is being issued HHS. a State must provide notice to FDA consistent with FDA’s good guidance ACTION: Notice. according to § 100.2 (21 CFR 100.2). The practices regulation (21 CFR 10.115). information required in a letter of The guidance represents the current SUMMARY: The Food and Drug notification under § 100.2(d) enables us thinking of FDA on QIDP designation. It Administration (FDA or we) is to identify the food against which a does not establish any rights for any announcing that a proposed collection State intends to take action and to person and is not binding on FDA or the of information has been submitted to the advise that State whether Federal public. You can use an alternative Office of Management and Budget enforcement action against the food has approach if it satisfies the requirements (OMB) for review and clearance under been taken or is in process. With certain of the applicable statutes and the Paperwork Reduction Act of 1995. narrow exceptions, Federal enforcement regulations. DATES: Submit written comments action precludes State action under the II. Paperwork Reduction Act of 1995 (including recommendations) on the FD&C Act. While this guidance contains no collection of information by June 11, In the Federal Register of December collection of information, it does refer to 2021. 17, 2020 (85 FR 81932), FDA published previously approved FDA collections of ADDRESSES: To ensure that comments on a 60-day notice requesting public information. Therefore, clearance by the the information collection are received, comment on the proposed collection of Office of Management and Budget OMB recommends that written information. No comments were (OMB) under the Paperwork Reduction comments be submitted to https:// received. Act of 1995 (PRA) (44 U.S.C. 3501– www.reginfo.gov/public/do/PRAMain. FDA estimates the burden of this 3521) is not required for this guidance. Find this particular information collection of information as follows:

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Number of Average 21 CFR section Number of responses per Total annual burden per Total hours respondents respondent responses response

100.2(d) ...... 1 1 1 10 10 1 There are no capital costs or operating and maintenance costs associated with this collection of information.

Based on a review of the information OMB approval, we have made no The estimated reporting burden for collection since our last request for adjustments to our burden estimate. § 100.2(d) is minimal because

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enforcement notifications are seldom so to improve the reliability of decisions ‘‘Confidential Submissions,’’ publicly used by States. During the last 3 years, about and representations of the effects viewable at https://www.regulations.gov we have not received any new of medical products. The guidance or at the Dockets Management Staff enforcement notifications; therefore, we replaces the draft guidance issued on between 9 a.m. and 4 p.m., Monday estimate that one or fewer notifications October 31, 2017. through Friday, 240–402–7500. • will be submitted annually. Although DATES: The announcement of the Confidential Submissions—To we have not received any new guidance is published in the Federal submit a comment with confidential enforcement notifications in the last 3 Register on May 12, 2021. information that you do not wish to be years, we believe these information made publicly available, submit your ADDRESSES: You may submit either collection provisions should be comments only as a written/paper electronic or written comments on extended to provide for the potential submission. You should submit two Agency guidances at any time as future need of a State government to copies total. One copy will include the follows: submit enforcement notifications information you claim to be confidential informing us when it intends to take Electronic Submissions with a heading or cover note that states ‘‘THIS DOCUMENT CONTAINS enforcement action under the FD&C Act Submit electronic comments in the against a particular food located in the CONFIDENTIAL INFORMATION.’’ The following way: State. Agency will review this copy, including • Federal eRulemaking Portal: Dated: May 5, 2021. the claimed confidential information, in https://www.regulations.gov. Follow the its consideration of comments. The Lauren K. Roth, instructions for submitting comments. second copy, which will have the Acting Principal Associate Commissioner for Comments submitted electronically, claimed confidential information Policy. including attachments, to https:// redacted/blacked out, will be available [FR Doc. 2021–09968 Filed 5–11–21; 8:45 am] www.regulations.gov will be posted to for public viewing and posted on BILLING CODE 4164–01–P the docket unchanged. Because your https://www.regulations.gov. Submit comment will be made public, you are both copies to the Dockets Management solely responsible for ensuring that your Staff. If you do not wish your name and DEPARTMENT OF HEALTH AND comment does not include any HUMAN SERVICES contact information to be made publicly confidential information that you or a available, you can provide this third party may not wish to be posted, Food and Drug Administration information on the cover sheet and not such as medical information, your or in the body of your comments and you [Docket No. FDA–2017–D–6113] anyone else’s Social Security number, or must identify this information as confidential business information, such ‘‘confidential.’’ Any information marked E9(R1) Statistical Principles for Clinical as a manufacturing process. Please note as ‘‘confidential’’ will not be disclosed Trials: Addendum: Estimands and that if you include your name, contact except in accordance with 21 CFR 10.20 Sensitivity Analysis in Clinical Trials; information, or other information that and other applicable disclosure law. For International Council for identifies you in the body of your more information about FDA’s posting Harmonisation; Guidance for Industry; comments, that information will be of comments to public dockets, see 80 Availability posted on https://www.regulations.gov. FR 56469, September 18, 2015, or access • AGENCY: Food and Drug Administration, If you want to submit a comment the information at: https:// HHS. with confidential information that you www.govinfo.gov/content/pkg/FR-2015- do not wish to be made available to the ACTION: Notice of availability. 09-18/pdf/2015-23389.pdf. public, submit the comment as a Docket: For access to the docket to SUMMARY: The Food and Drug written/paper submission and in the read background documents or the Administration (FDA or Agency) is manner detailed (see ‘‘Written/Paper electronic and written/paper comments announcing the availability of a final Submissions’’ and ‘‘Instructions’’). received, go to https:// guidance for industry entitled ‘‘E9(R1) Written/Paper Submissions www.regulations.gov and insert the Statistical Principles for Clinical Trials: docket number, found in brackets in the Addendum: Estimands and Sensitivity Submit written/paper submissions as heading of this document, into the Analysis in Clinical Trials.’’ The follows: ‘‘Search’’ box and follow the prompts guidance was prepared under the • Mail/Hand Delivery/Courier (for and/or go to the Dockets Management auspices of the International Council for written/paper submissions): Dockets Staff, 5630 Fishers Lane, Rm. 1061, Harmonisation (ICH), formerly the Management Staff (HFA–305), Food and Rockville, MD 20852, 240–402–7500. International Conference on Drug Administration, 5630 Fishers You may submit comments on any Harmonisation. The guidance clarifies, Lane, Rm. 1061, Rockville, MD 20852. guidance at any time (see 21 CFR updates, and extends the guidance for • For written/paper comments 10.115(g)(5)). industry ‘‘E9 Statistical Principles for submitted to the Dockets Management Submit written requests for single Clinical Trials’’ issued in September Staff, FDA will post your comment, as copies of this guidance to the Division 1998 in two main areas. Concerning well as any attachments, except for of Drug Information, Center for Drug estimands, it provides a framework for information submitted, marked and Evaluation and Research, Food and discussion of how the aims of a trial identified, as confidential, if submitted Drug Administration, 10001 New relate to the proposed statistical as detailed in ‘‘Instructions.’’ Hampshire Ave., Hillandale Building, analysis. Concerning sensitivity Instructions: All submissions received 4th Floor, Silver Spring, MD 20993– analysis, it discusses how to use must include the Docket No. FDA– 0002, or the Office of Communication, additional analyses to address concerns 2017–D–6113 for ‘‘E9(R1) Statistical Outreach and Development, Center for about the validity of assumptions Principles for Clinical Trials: Biologics Evaluation and Research underlying the main analysis. The Addendum: Estimands and Sensitivity (CBER), Food and Drug Administration, guidance is intended to better align the Analysis in Clinical Trials.’’ Received 10903 New Hampshire Ave., Bldg. 71, choice of statistical methods with comments will be placed in the docket Rm. 3128, Silver Spring, MD 20993– questions of regulatory importance and and, except for those submitted as 0002. Send one self-addressed adhesive

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label to assist that office in processing industry associations from around the practices regulation (21 CFR 10.115). your requests. The guidance may also be world (refer to https://www.ich.org/). The guidance represents the current obtained by mail by calling CBER at 1– ICH works by involving technical thinking of FDA on ‘‘E9(R1) Statistical 800–835–4709 or 240–402–8010. See experts from both regulators and Principles for Clinical Trials: the SUPPLEMENTARY INFORMATION section industry parties in detailed technical Addendum: Estimands and Sensitivity for electronic access to the guidance harmonization work and the application Analysis in Clinical Trials.’’ It does not document. of a science-based approach to establish any rights for any person and harmonization through a consensus- is not binding on FDA or the public. FOR FURTHER INFORMATION CONTACT: driven process that results in the You can use an alternative approach if Regarding the guidance: Scott Goldie, development of ICH guidelines. The it satisfies the requirements of the Center for Drug Evaluation and regulators around the world are applicable statutes and regulations. Research, Food and Drug committed to consistently adopting Administration, Bldg. 21, Rm. 3557, these consensus-based guidelines, II. Electronic Access Silver Spring, MD 20993–0002, 301– realizing the benefits for patients and for Persons with access to the internet 796–2055, [email protected]; or industry. may obtain the guidance at https:// Stephen Ripley, Center for Biologics As a Founding Regulatory Member of www.regulations.gov, https:// Evaluation and Research, Food and ICH, FDA plays a major role in the www.fda.gov/drugs/guidance- Drug Administration, Bldg. 71, Rm. development of each of the ICH compliance-regulatory-information/ 7301, Silver Spring, MD 20993–0002, guidelines, which FDA then adopts and guidances-drugs, or https:// 240–402–7911. issues as guidance for industry. FDA’s www.fda.gov/vaccines-blood-biologics/ Regarding the ICH: Jill Adleberg, guidance documents do not establish guidance-compliance-regulatory- Center for Drug Evaluation and legally enforceable responsibilities. information-biologics/biologics- Research, Food and Drug Instead, they describe the Agency’s guidances. Administration, 10903 New Hampshire current thinking on a topic and should Dated: May 7, 2021. Ave., Bldg. 51, Rm. 6364, Silver Spring, be viewed only as recommendations, Lauren K. Roth, unless specific regulatory or statutory MD 20993–0002, 301–796–5259. Acting Principal Associate Commissioner for SUPPLEMENTARY INFORMATION: requirements are cited. Policy. In the Federal Register of October 31, I. Background 2017 (82 FR 50433), FDA published a [FR Doc. 2021–10066 Filed 5–11–21; 8:45 am] notice announcing the availability of a BILLING CODE 4164–01–P FDA is announcing the availability of draft guidance entitled ‘‘E9(R1) a guidance for industry entitled ‘‘E9(R1) Statistical Principles for Clinical Trials: Statistical Principles for Clinical Trials: DEPARTMENT OF HEALTH AND Addendum: Estimands and Sensitivity Addendum: Estimands and Sensitivity HUMAN SERVICES Analysis in Clinical Trials.’’ The notice Analysis in Clinical Trials.’’ The gave interested persons an opportunity Food and Drug Administration guidance was prepared under the to submit comments by April 30, 2018. auspices of ICH. ICH has the mission of After consideration of the comments [Docket No. FDA–2017–D–5138] achieving greater regulatory received and revisions to the guideline, S5(R3) Detection of Reproductive and harmonization worldwide to ensure that a final draft of the guideline was Developmental Toxicity for Human safe, effective, high-quality medicines submitted to the ICH Assembly and Pharmaceuticals; International Council are developed, registered, and endorsed by the regulatory agencies in for Harmonisation; Guidance for maintained in the most resource- November 2019. efficient manner. This guidance finalizes the draft Industry; Availability By harmonizing the regulatory guidance issued on October 31, 2017. AGENCY: Food and Drug Administration, requirements in regions around the The guidance provides clarification on HHS. world, ICH guidelines have statistical principles for clinical trials ACTION: Notice of availability. substantially reduced duplicative and an update on the choice of estimand clinical studies, prevented unnecessary to describe a framework for planning, SUMMARY: The Food and Drug animal studies, standardized the conducting, and interpreting sensitivity Administration (FDA or Agency) is reporting of important safety analyses of clinical trial data. The focus announcing the availability of a final information, standardized marketing of the guidance is on statistical guidance for industry entitled ‘‘S5(R3) application submissions, and made principles related to estimands and Detection of Reproductive and many other improvements in the quality sensitivity analysis for confirmatory Developmental Toxicity for Human of global drug development and clinical trials. The guidance provides Pharmaceuticals.’’ The guidance was manufacturing and the products recommendations for aligning the prepared under the auspices of the available to patients. choice of statistical methods with the International Council for Harmonisation The six Founding Members of the ICH goals of a clinical trial; on of Technical Requirements for are FDA; the Pharmaceutical Research communicating the rationale for such Pharmaceuticals for Human Use (ICH), and Manufacturers of America; the choices to FDA; and on using sensitivity formerly the International Conference European Commission; the European analysis to characterize the robustness on Harmonisation of Technical Federation of Pharmaceutical Industries of the conclusions to plausible Requirements for Registration of Associations; the Japanese Ministry of deviations from the assumptions of the Pharmaceuticals for Human Use. The Health, Labour, and Welfare; and the main analysis. Revisions made guidance provides key considerations Japanese Pharmaceutical Manufacturers following the public comment period for developing a testing strategy to Association. The Standing Members of are intended to clarify content within identify hazard and characterize the ICH Association include Health the guidance; however, no new concepts reproductive risk for human Canada and Swissmedic. Additionally, are presented in the revised version. pharmaceuticals. The guidance is the Membership of ICH has expanded to This guidance is being issued intended to align with other ICH include other regulatory authorities and consistent with FDA’s good guidance guidances, elaborate on concepts to

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consider when designing studies, and Received comments will be placed in 10903 New Hampshire Ave., Bldg. 71, identify potential circumstances in the docket and, except for those Rm. 3128, Silver Spring, MD 20993– which a risk assessment can be made submitted as ‘‘Confidential 0002. Send one self-addressed adhesive based on preliminary studies. It also Submissions,’’ publicly viewable at label to assist that office in processing clarifies the qualification and potential https://www.regulations.gov or at the your requests. The guidance may also be use of alternative assays. This guidance Dockets Management Staff between 9 obtained by mail by calling CBER at 1– finalizes the draft guidance issued on a.m. and 4 p.m., Monday through 800–835–4709 or 240–402–8010. See November 13, 2017. Friday, 240–402–7500. the SUPPLEMENTARY INFORMATION section • DATES: The announcement of the Confidential Submissions—To for electronic access to the guidance guidance is published in the Federal submit a comment with confidential document. information that you do not wish to be Register on May 12, 2021. FOR FURTHER INFORMATION CONTACT: made publicly available, submit your ADDRESSES Regarding the guidance: Ronald Wange, : You may submit either comments only as a written/paper electronic or written comments on submission. You should submit two Center for Drug Evaluation and Agency guidances at any time as copies total. One copy will include the Research, Food and Drug follows: information you claim to be confidential Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 3342, Silver Spring, Electronic Submissions with a heading or cover note that states ‘‘THIS DOCUMENT CONTAINS MD 20993–0002, 301–796–1304; or Submit electronic comments in the CONFIDENTIAL INFORMATION.’’ The Stephen Ripley, Center for Biologics following way: Evaluation and Research, Food and • Agency will review this copy, including Federal eRulemaking Portal: the claimed confidential information, in Drug Administration, 10903 New https://www.regulations.gov. Follow the its consideration of comments. The Hampshire Ave., Bldg. 71, Rm. 7301, instructions for submitting comments. second copy, which will have the Silver Spring, MD 20993–0002, 240– Comments submitted electronically, claimed confidential information 402–7911. including attachments, to https:// redacted/blacked out, will be available Regarding the ICH: Jill Adleberg, www.regulations.gov will be posted to for public viewing and posted on Center for Drug Evaluation and the docket unchanged. Because your https://www.regulations.gov. Submit Research, Food and Drug comment will be made public, you are both copies to the Dockets Management Administration, 10903 New Hampshire solely responsible for ensuring that your Staff. If you do not wish your name and Ave., Bldg. 51, Rm. 6364, Silver Spring, comment does not include any contact information to be made publicly MD 20993–0002, 301–796–5259, confidential information that you or a available, you can provide this [email protected]. third party may not wish to be posted, information on the cover sheet and not SUPPLEMENTARY INFORMATION: such as medical information, your or in the body of your comments and you I. Background anyone else’s Social Security number, or must identify this information as confidential business information, such ‘‘confidential.’’ Any information marked FDA is announcing the availability of as a manufacturing process. Please note as ‘‘confidential’’ will not be disclosed a guidance for industry entitled ‘‘S5(R3) that if you include your name, contact except in accordance with 21 CFR 10.20 Detection of Reproductive and information, or other information that and other applicable disclosure law. For Developmental Toxicity for Human identifies you in the body of your more information about FDA’s posting Pharmaceuticals.’’ The guidance was comments, that information will be of comments to public dockets, see 80 prepared under the auspices of ICH. ICH posted on https://www.regulations.gov. FR 56469, September 18, 2015, or access has the mission of achieving greater • If you want to submit a comment the information at: https:// regulatory harmonization worldwide to with confidential information that you www.govinfo.gov/content/pkg/FR-2015- ensure that safe, effective, high-quality do not wish to be made available to the 09-18/pdf/2015-23389.pdf. medicines are developed, registered, public, submit the comment as a Docket: For access to the docket to and maintained in the most resource- written/paper submission and in the read background documents or the efficient manner. manner detailed (see ‘‘Written/Paper electronic and written/paper comments By harmonizing the regulatory Submissions’’ and ‘‘Instructions’’). received, go to https:// requirements in regions around the world, ICH guidelines have Written/Paper Submissions www.regulations.gov and insert the docket number, found in brackets in the substantially reduced duplicative Submit written/paper submissions as heading of this document, into the clinical studies, prevented unnecessary follows: ‘‘Search’’ box and follow the prompts animal studies, standardized the • Mail/Hand Delivery/Courier (for and/or go to the Dockets Management reporting of important safety written/paper submissions): Dockets Staff, 5630 Fishers Lane, Rm. 1061, information, standardized marketing Management Staff (HFA–305), Food and Rockville, MD 20852, 240–402–7500. application submissions, and made Drug Administration, 5630 Fishers You may submit comments on any many other improvements in the quality Lane, Rm. 1061, Rockville, MD 20852. guidance at any time (see 21 CFR of global drug development and • For written/paper comments 10.115(g)(5)). manufacturing and the products submitted to the Dockets Management Submit written requests for single available to patients. Staff, FDA will post your comment, as copies of this guidance to the Division The six Founding Members of the ICH well as any attachments, except for of Drug Information, Center for Drug are FDA; the Pharmaceutical Research information submitted, marked and Evaluation and Research, Food and and Manufacturers of America; the identified, as confidential, if submitted Drug Administration, 10001 New European Commission; the European as detailed in ‘‘Instructions.’’ Hampshire Ave., Hillandale Building, Federation of Pharmaceutical Industries Instructions: All submissions received 4th Floor, Silver Spring, MD 20993– Associations; the Japanese Ministry of must include the Docket No. FDA– 0002, or the Office of Communication, Health, Labour, and Welfare; and the 2017–D–5138 for ‘‘S5(R3) Detection of Outreach and Development, Center for Japanese Pharmaceutical Manufacturers Reproductive and Developmental Biologics Evaluation and Research Association. The Standing Members of Toxicity for Human Pharmaceuticals.’’ (CBER), Food and Drug Administration, the ICH Association include Health

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Canada and Swissmedic. Additionally, clinical development and marketing 0910–0119; the collections of the Membership of ICH has expanded to approval. information in 21 CFR part 314 have include other regulatory authorities and This guidance applies to been approved under OMB control industry associations from around the pharmaceuticals, including number 0910–0001; the collections of world (refer to https://www.ich.org/). biotechnology-derived pharmaceuticals; information in 21 CFR part 312 have ICH works by involving technical vaccines (and their novel constitutive been approved under OMB control experts from both regulators and ingredients) for infectious diseases; and number 0910–0014; and the content and industry parties in detailed technical novel excipients that are part of the final format requirements for pregnancy and harmonization work and the application pharmaceutical product. It does not lactation labeling of human prescription of a science-based approach to apply to cellular therapies, gene drug and biological products have been harmonization through a consensus- therapies, and tissue-engineered approved under OMB control number driven process that results in the products. The methodological 0910–0624. development of ICH guidelines. The principles (e.g., study design, dose regulators around the world are selection, and species selection) III. Electronic Access committed to consistently adopting outlined in this guidance can also apply Persons with access to the internet these consensus-based guidelines, to all compounds for which the conduct may obtain the guidance at https:// realizing the benefits for patients and for of reproductive and/or developmental www.regulations.gov, https:// industry. toxicity studies is appropriate, www.fda.gov/drugs/guidance- As a Founding Regulatory Member of including vaccines for other indications compliance-regulatory-information/ ICH, FDA plays a major role in the (e.g., cancer). (see ICH guidance for guidances-drugs, or https:// development of each of the ICH industry ‘‘S9 Nonclinical Evaluation for www.fda.gov/vaccines-blood-biologics/ guidelines, which FDA then adopts and Anticancer Pharmaceuticals’’ (March guidance-compliance-regulatory- issues as guidance for industry. FDA’s 2010), available at https://www.fda.gov/ information-biologics/biologics- guidance documents do not establish media/73161/download). guidances. legally enforceable responsibilities. The guidance reflects revisions made Dated: May 6, 2021. Instead, they describe the Agency’s in response to comments received on Lauren K. Roth, current thinking on a topic and should the draft guidance. These include Acting Principal Associate Commissioner for be viewed only as recommendations, reorganization of the guidance to Policy. unless specific regulatory or statutory improve readability and clarity, to [FR Doc. 2021–10017 Filed 5–11–21; 8:45 am] requirements are cited. introduce discussion of conventional In the Federal Register of November assessment strategies earlier in the BILLING CODE 4164–01–P 13, 2017 (82 FR 52306), FDA published document, and to clarify which a notice announcing the availability of elements of the guidance are more DEPARTMENT OF HEALTH AND a draft guidance entitled ‘‘S5(R3) appropriate for biotechnology-derived HUMAN SERVICES Detection of Toxicity to Reproduction therapies. To accommodate the rapidly for Human Pharmaceuticals.’’ The evolving nature of alternative assay Food and Drug Administration notice gave interested persons an development, the discussion of opportunity to submit comments by alternative assays was placed in an [Docket No. FDA–2020–D–1370] February 12, 2018. Annex, subject to a maintenance COVID–19: Developing Drugs and After consideration of the comments procedure, to allow for more frequent Biological Products for Treatment or received and revisions to the guideline, updating of this material. Prevention; Guidance for Industry; a final draft of the guideline was This guidance is being issued Availability submitted to the ICH Assembly and consistent with FDA’s good guidance endorsed by the regulatory agency practices regulation (21 CFR 10.115). AGENCY: Food and Drug Administration, members in January 2020. The guidance represents the current HHS. The guidance finalizes the guidance thinking of FDA on ‘‘S5(R3) Detection of ACTION: Notice of availability. issued on November 13, 2017. The Reproductive and Developmental guidance has undergone revisions to Toxicity for Human Pharmaceuticals.’’ It SUMMARY: The Food and Drug align with other ICH guidances, does not establish any rights for any Administration (FDA or Agency) is elaborate on concepts to consider when person and is not binding on FDA or the announcing the availability of a final designing studies, and identify potential public. You can use an alternative guidance for industry entitled ‘‘COVID– circumstances in which a risk approach if it satisfies the requirements 19: Developing Drugs and Biological assessment can be made based on of the applicable statutes and Products for Treatment or Prevention.’’ preliminary studies. It also clarifies the regulations. This guidance describes FDA’s current qualification and potential use of recommendations regarding phase 2 or alternative assays. II. Paperwork Reduction Act of 1995 phase 3 trials for drugs or biological The purpose of this guidance is to This guidance contains no collection products under development for the provide key considerations for of information. Therefore, clearance by treatment or prevention of COVID–19. developing a testing strategy to identify the Office of Management and Budget Given the public health emergency hazard and characterize reproductive (OMB) under the Paperwork Reduction presented by COVID–19, this guidance risk for human pharmaceuticals. The Act of 1995 (PRA) (44 U.S.C. 3501– document is being implemented guidance informs on the use of existing 3521) is not required. without prior public comment because data and identifies potential study However, this guidance refers to FDA has determined that prior public designs to supplement available data to previously approved FDA collections of participation is not feasible or identify, assess, and convey risk. information. These collections of appropriate, but it remains subject to General concepts and recommendations information are subject to review by comment in accordance with the are provided that should be considered OMB under the PRA. The collections of Agency’s good guidance practices. This when interpreting study data and information in 21 CFR part 58 have been final guidance revises and replaces the assessing reproductive risk in support of approved under OMB control number final guidance of the same name issued

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on May 11, 2020. Revisions were made 2020–D–1370 for ‘‘COVID–19: Outreach and Development, Center for to address the evolving landscape of Developing Drugs and Biological Biologics Evaluation and Research, COVID–19 drug development, including Products for Treatment or Prevention.’’ Food and Drug Administration, 10903 the emergence of SARS-CoV–2 variants Received comments will be placed in New Hampshire Ave., Bldg. 71, Rm. and the availability of COVID–19 the docket and, except for those 3128, Silver Spring, MD 20993–0002. vaccines. The revision to this guidance submitted as ‘‘Confidential Send one self-addressed adhesive label was posted to the FDA website on Submissions,’’ publicly viewable at to assist that office in processing your February 22, 2021. https://www.regulations.gov or at the requests. See the SUPPLEMENTARY DATES: The announcement of the Dockets Management Staff between 9 INFORMATION section for electronic guidance is published in the Federal a.m. and 4 p.m., Monday through access to the guidance document. Friday, 240–402–7500. FOR FURTHER INFORMATION CONTACT: Register on May 12, 2021. The guidance • document is immediately in effect, but Confidential Submissions—To Eithu Lwin, Center for Drug Evaluation it remains subject to comment in submit a comment with confidential and Research, Food and Drug accordance with the Agency’s good information that you do not wish to be Administration, 10903 New Hampshire guidance practices. made publicly available, submit your Ave., Bldg. 22, Rm. 6236, Silver Spring, comments only as a written/paper ADDRESSES: You may submit electronic MD 20993–0002, 301–796–0728; or submission. You should submit two Stephen Ripley, Center for Biologics or written comments on Agency copies total. One copy will include the guidances at any time as follows: Evaluation and Research, Food and information you claim to be confidential Drug Administration, 10903 New Electronic Submissions with a heading or cover note that states Hampshire Ave., Bldg. 71, Rm. 7301, ‘‘THIS DOCUMENT CONTAINS Silver Spring, MD 20993–0002, 240– Submit electronic comments in the CONFIDENTIAL INFORMATION.’’ The following way: 402–7911. • Agency will review this copy, including Federal eRulemaking Portal: the claimed confidential information, in SUPPLEMENTARY INFORMATION: https://www.regulations.gov. Follow the its consideration of comments. The I. Background instructions for submitting comments. second copy, which will have the Comments submitted electronically, claimed confidential information FDA is announcing the availability of including attachments, to https:// redacted/blacked out, will be available a guidance for industry entitled www.regulations.gov will be posted to for public viewing and posted on ‘‘COVID–19: Developing Drugs and the docket unchanged. Because your https://www.regulations.gov. Submit Biological Products for Treatment or comment will be made public, you are both copies to the Dockets Management Prevention.’’ There is currently an solely responsible for ensuring that your Staff. If you do not wish your name and outbreak of respiratory disease caused comment does not include any contact information to be made publicly by a novel coronavirus. The virus has confidential information that you or a available, you can provide this been named SARS-CoV–2, and the third party may not wish to be posted, information on the cover sheet and not disease it causes has been named such as medical information, your or in the body of your comments and you Coronavirus Disease 2019 (COVID–19). anyone else’s Social Security number, or must identify this information as On January 31, 2020, the Department of confidential business information, such ‘‘confidential.’’ Any information marked Health and Human Services (HHS) as a manufacturing process. Please note as ‘‘confidential’’ will not be disclosed issued a declaration of a public health that if you include your name, contact except in accordance with 21 CFR 10.20 emergency related to COVID–19 and information, or other information that and other applicable disclosure law. For mobilized the Operating Divisions of identifies you in the body of your more information about FDA’s posting HHS. The public health emergency comments, that information will be of comments to public dockets, see 80 declaration has been subsequently posted on https://www.regulations.gov. FR 56469, September 18, 2015, or access renewed. In addition, on March 13, • If you want to submit a comment the information at: https:// 2020, the President declared a national with confidential information that you www.govinfo.gov/content/pkg/FR-2015- emergency in response to COVID–19. do not wish to be made available to the 09-18/pdf/2015-23389.pdf. The revision to this guidance was public, submit the comment as a Docket: For access to the docket to posted to the FDA website on February written/paper submission and in the read background documents or the 22, 2021. manner detailed (see ‘‘Written/Paper electronic and written/paper comments This guidance describes FDA’s Submissions’’ and ‘‘Instructions’’). received, go to https:// current recommendations regarding phase 2 or phase 3 trials for drugs under Written/Paper Submissions www.regulations.gov and insert the docket number, found in brackets in the development to treat or prevent COVID– Submit written/paper submissions as heading of this document, into the 19. This guidance focuses on the patient follows: ‘‘Search’’ box and follow the prompts population, trial design, efficacy • Mail/Hand Delivery/Courier (for and/or go to the Dockets Management endpoints, safety considerations, and written/paper submissions): Dockets Staff, 5630 Fishers Lane, Rm. 1061, statistical considerations for such trials. Management Staff (HFA–305), Food and Rockville, MD 20852, 240–402–7500. Drugs should have undergone sufficient Drug Administration, 5630 Fishers You may submit comments on any development before their evaluation in Lane, Rm. 1061, Rockville, MD 20852. guidance at any time (see 21 CFR phase 2 or phase 3. • For written/paper comments 10.115(g)(5)). This guidance focuses on the submitted to the Dockets Management Submit written requests for single development of drugs with direct Staff, FDA will post your comment, as copies of the guidance to the Division of antiviral activity or immunomodulatory well as any attachments, except for Drug Information, Center for Drug activity. However, the recommendations information submitted, marked and Evaluation and Research, Food and in this guidance may be applicable to identified, as confidential, if submitted Drug Administration, 10001 New development plans for drugs for as detailed in ‘‘Instructions.’’ Hampshire Ave., Hillandale Building, COVID–19 with other mechanisms of Instructions: All submissions received 4th Floor, Silver Spring, MD 20993– action. The mechanism of action of the must include the Docket No. FDA– 0002; or the Office of Communication, drug may impact key study design

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elements (e.g., population, endpoints, The guidance represents the current vaccines-blood-biologics/guidance- safety assessments, duration of thinking of FDA on ‘‘COVID–19: compliance-regulatory-information- followup, etc.). Developing Drugs and Biological biologics, https://www.fda.gov/ Preventative vaccines are not within Products for Treatment or Prevention.’’ emergency-preparedness-and-response/ the scope of this guidance. Nor does this It does not establish any rights for any mcm-issues/covid-19-related-guidance- guidance provide general person and is not binding on FDA or the documents-industry-fda-staff-and-other- recommendations on early drug public. You can use an alternative stakeholders, or https:// development in COVID–19, such as use approach if it satisfies the requirements www.regulations.gov. of animal models. of the applicable statutes and Dated: May 7, 2021. In light of the public health regulations. emergency related to COVID–19 Lauren K. Roth, declared by the Secretary of HHS, FDA II. Paperwork Reduction Act of 1995 Acting Principal Associate Commissioner for has determined that prior public While this guidance contains no Policy. participation for this guidance is not collection of information, it does refer to [FR Doc. 2021–10061 Filed 5–11–21; 8:45 am] feasible or appropriate and is issuing previously approved FDA collections of BILLING CODE 4164–01–P this guidance without prior public information. Therefore, clearance by the comment (see section 701(h)(1)(C)(i) of Office of Management and Budget the Federal Food, Drug, and Cosmetic (OMB) under the Paperwork Reduction DEPARTMENT OF HEALTH AND Act (21 U.S.C. 371(h)(1)(C)(i)) and 21 Act of 1995 (PRA) (44 U.S.C. 3501– HUMAN SERVICES CFR 10.115(g)(2)). This guidance 3521) is not required for this guidance. Food and Drug Administration document is being implemented The previously approved collections of immediately, but it remains subject to information are subject to review by [Docket No. FDA–2013–D–1156] comment in accordance with the OMB under the PRA. The collections of Agency’s good guidance practices. information in 21 CFR part 314 have Q3D(R2)—Guideline for Elemental This guidance is intended to remain been approved under OMB control Impurities; International Council for in effect for the duration of the public number 0910–0001; the collections of Harmonisation; Draft Guidance for health emergency related to COVID–19 information in 21 CFR parts 312 and Industry; Availability declared by HHS, including any 320 have been approved under OMB AGENCY: Food and Drug Administration, renewals made by the Secretary in control number 0910–0014; the HHS. accordance with section 319(a)(2) of the collections of information in 21 CFR Public Health Service Act (42 U.S.C. part 58 regarding good laboratory ACTION: Notice of availability. 247d(a)(2)). However, the practice for nonclinical laboratory SUMMARY: The Food and Drug recommendations and processes studies have been approved under OMB Administration (FDA or Agency) is described in the guidance are expected control number 0910–0119; the announcing the availability of a draft to assist the Agency more broadly in its collections of information in 21 CFR guidance for industry entitled continued efforts to assist sponsors in parts 50 and 56 have been approved ‘‘Q3D(R2)—Guideline for Elemental the clinical development of drugs for under OMB control number 0910–0130; Impurities.’’ The draft guidance was the treatment of COVID–19 beyond the the collections of information in 21 CFR prepared under the auspices of the termination of the COVID–19 public part 320 have been approved under International Council for Harmonisation health emergency and reflect the OMB control number 0910–0291; the (ICH), formerly the International Agency’s current thinking on this issue. collections of information in 21 CFR Conference on Harmonisation. The draft Therefore, within 60 days following the part 601 have been approved under guidance provides Permissible Daily termination of the public health OMB control number 0910–0338; the Exposures (PDEs) for the cutaneous and emergency, FDA intends to revise and collections of information in FDA’s draft transcutaneous routes of administration replace this guidance with any guidance for industry entitled ‘‘Formal and relevant risk assessment appropriate changes based on comments Meetings Between the FDA and considerations to supplement previous received on this guidance and the Sponsors or Applicants of Prescription guidance for the oral, parenteral, and Agency’s experience with Drug User Fee Act Products’’ have been inhalation routes of administration. In implementation. approved under OMB control number addition, error corrections to previously This final guidance revises and 0910–0429; the collections of identified PDEs for gold (oral, replaces the final guidance with the information in FDA’s final guidance for parenteral, and inhalation routes), silver same title issued on May 19, 2020 (85 clinical trial sponsors entitled (parenteral route), and nickel FR 29949). The revision addresses the ‘‘Establishment and Operation of (inhalation route) are provided. The potential impact of the emergence of Clinical Trial Data Monitoring draft guidance is intended to SARS-CoV–2 variants and the Committees’’ have been approved under recommend acceptable amounts for the availability of COVID–19 vaccines. OMB control number 0910–0581; and listed elemental impurities in Additional updates reflecting the the collections of information in FDA’s pharmaceuticals for the safety of the evolving landscape of COVID–19 drug final guidance for industry entitled patient and provide recommendations development were made to the ‘‘Oversight of Clinical Investigations—A for conducting a risk assessment for recommendations on patient Risk-Based Approach to Monitoring’’ pharmaceutical products. population, trial design, efficacy have been approved under OMB control endpoints, safety considerations, and number 0910–0733. DATES: Submit either electronic or statistical considerations. In addition, written comments on the draft guidance FDA considered comments received on III. Electronic Access by June 11, 2021 to ensure that the the previous guidance, and editorial Persons with access to the internet Agency considers your comment on this changes were made to improve clarity. may obtain the guidance at https:// draft guidance before it begins work on This guidance is being issued www.fda.gov/drugs/guidance- the final version of the guidance. consistent with FDA’s good guidance compliance-regulatory-information/ ADDRESSES: You may submit comments practices regulation (21 CFR 10.115). guidances-drugs, https://www.fda.gov/ on any guidance at any time as follows:

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Electronic Submissions CONFIDENTIAL INFORMATION.’’ The [email protected]; or Submit electronic comments in the Agency will review this copy, including Stephen Ripley, Center for Biologics following way: the claimed confidential information, in Evaluation and Research, Food and • Federal eRulemaking Portal: its consideration of comments. The Drug Administration, 10903 New https://www.regulations.gov. Follow the second copy, which will have the Hampshire Ave., Bldg. 71, Rm. 7301, instructions for submitting comments. claimed confidential information Silver Spring, MD 20993–0002, 240– Comments submitted electronically, redacted/blacked out, will be available 402–7911. Regarding the ICH: Jill Adleberg, including attachments, to https:// for public viewing and posted on Center for Drug Evaluation and www.regulations.gov will be posted to https://www.regulations.gov. Submit Research, Food and Drug the docket unchanged. Because your both copies to the Dockets Management Administration, 10903 New Hampshire comment will be made public, you are Staff. If you do not wish your name and Ave., Bldg. 51, Rm. 6364, Silver Spring, solely responsible for ensuring that your contact information to be made publicly available, you can provide this MD 20993–0002, 301–796–5259, comment does not include any [email protected]. confidential information that you or a information on the cover sheet and not SUPPLEMENTARY INFORMATION: third party may not wish to be posted, in the body of your comments and you such as medical information, your or must identify this information as I. Background anyone else’s Social Security number, or ‘‘confidential.’’ Any information marked as ‘‘confidential’’ will not be disclosed FDA is announcing the availability of confidential business information, such a draft guidance for industry entitled as a manufacturing process. Please note except in accordance with 21 CFR 10.20 and other applicable disclosure law. For ‘‘Q3D(R2)—Guideline for Elemental that if you include your name, contact Impurities.’’ The draft guidance was information, or other information that more information about FDA’s posting of comments to public dockets, see 80 prepared under the auspices of ICH. ICH identifies you in the body of your has the mission of achieving greater comments, that information will be FR 56469, September 18, 2015, or access the information at: https:// regulatory harmonization worldwide to posted on https://www.regulations.gov. ensure that safe, effective, high-quality • If you want to submit a comment www.govinfo.gov/content/pkg/FR-2015- 09-18/pdf/2015-23389.pdf. medicines are developed, registered, with confidential information that you and maintained in the most resource- do not wish to be made available to the Docket: For access to the docket to read background documents or the efficient manner. public, submit the comment as a By harmonizing the regulatory written/paper submission and in the electronic and written/paper comments received, go to https:// requirements in regions around the manner detailed (see ‘‘Written/Paper world, ICH guidelines have Submissions’’ and ‘‘Instructions’’). www.regulations.gov and insert the docket number, found in brackets in the substantially reduced duplicative clinical studies, prevented unnecessary Written/Paper Submissions heading of this document, into the animal studies, standardized the ‘‘Search’’ box and follow the prompts Submit written/paper submissions as reporting of important safety and/or go to the Dockets Management follows: information, standardized marketing • Staff, 5630 Fishers Lane, Rm. 1061, Mail/Hand Delivery/Courier (for application submissions, and made Rockville, MD 20852, 240–402–7500. written/paper submissions): Dockets many other improvements in the quality You may submit comments on any Management Staff (HFA–305), Food and of global drug development and guidance at any time (see 21 CFR Drug Administration, 5630 Fishers manufacturing and the products 10.115(g)(5)). Lane, Rm. 1061, Rockville, MD 20852. available to patients. Submit written requests for single • For written/paper comments The six Founding Members of the ICH copies of this guidance to the Division submitted to the Dockets Management are FDA; the Pharmaceutical Research Staff, FDA will post your comment, as of Drug Information, Center for Drug and Manufacturers of America; the well as any attachments, except for Evaluation and Research, Food and European Commission; the European information submitted, marked and Drug Administration, 10001 New Federation of Pharmaceutical Industries identified, as confidential, if submitted Hampshire Ave., Hillandale Building, Associations; the Japanese Ministry of as detailed in ‘‘Instructions.’’ 4th Floor, Silver Spring, MD 20993– Health, Labour, and Welfare; and the Instructions: All submissions received 0002, or the Office of Communication, Japanese Pharmaceutical Manufacturers must include the Docket No. FDA– Outreach and Development, Center for Association. The Standing Members of 2013–D–1156 for ‘‘Q3D(R2)—Guideline Biologics Evaluation and Research the ICH Association include Health for Elemental Impurities.’’ Received (CBER), Food and Drug Administration, Canada and Swissmedic. Additionally, comments will be placed in the docket 10903 New Hampshire Ave., Bldg. 71, the Membership of ICH has expanded to and, except for those submitted as Rm. 3128, Silver Spring, MD 20993– include other regulatory authorities and ‘‘Confidential Submissions,’’ publicly 0002. Send one self-addressed adhesive industry associations from around the viewable at https://www.regulations.gov label to assist that office in processing world (refer to https://www.ich.org/). or at the Dockets Management Staff your requests. The guidance may also be ICH works by involving technical between 9 a.m. and 4 p.m., Monday obtained by mail by calling CBER at 1– experts from both regulators and through Friday, 240–402–7500. 800–835–4709 or 240–402–8010. See industry parties in detailed technical • Confidential Submissions—To the SUPPLEMENTARY INFORMATION section harmonization work and the application submit a comment with confidential for electronic access to the guidance of a science-based approach to information that you do not wish to be document. harmonization through a consensus- made publicly available, submit your FOR FURTHER INFORMATION CONTACT: driven process that results in the comments only as a written/paper Regarding the guidance: Timothy development of ICH guidelines. The submission. You should submit two McGovern, Center for Drug Evaluation regulators around the world are copies total. One copy will include the and Research, Food and Drug committed to consistently adopting information you claim to be confidential Administration, 10903 New Hampshire these consensus-based guidelines, with a heading or cover note that states Ave., Bldg 22, Rm. 6426, Silver Spring, realizing the benefits for patients and for ‘‘THIS DOCUMENT CONTAINS MD 20993–0002, 240–402–0477, industry.

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As a Founding Regulatory Member of information-biologics/biologics- ADDRESSES: You may submit either ICH, FDA plays a major role in the guidances. electronic or written comments on development of each of the ICH Dated: May 7, 2021. Agency guidances at any time as guidelines, which FDA then adopts and Lauren K. Roth, follows: issues as guidance for industry. FDA’s Acting Principal Associate Commissioner for Electronic Submissions guidance documents do not establish Policy. legally enforceable responsibilities. Submit electronic comments in the Instead, they describe the Agency’s [FR Doc. 2021–10011 Filed 5–11–21; 8:45 am] following way: BILLING CODE 4164–01–P • current thinking on a topic and should Federal eRulemaking Portal: be viewed only as recommendations, https://www.regulations.gov. Follow the unless specific regulatory or statutory instructions for submitting comments. DEPARTMENT OF HEALTH AND Comments submitted electronically, requirements are cited. HUMAN SERVICES In September 2020, the ICH Assembly including attachments, to https:// endorsed the draft guidance entitled Food and Drug Administration www.regulations.gov will be posted to ‘‘Q3D(R2)—Guideline for Elemental the docket unchanged. Because your comment will be made public, you are Impurities’’ and agreed that the [Docket No. FDA–2018–D–3614] guidance should be made available for solely responsible for ensuring that your comment does not include any public comment. The draft guidance is M9 Biopharmaceutics Classification confidential information that you or a the product of the Quality Expert System-Based Biowaivers; third party may not wish to be posted, Working Group of the ICH. Comments International Council for such as medical information, your or about this draft guidance will be Harmonisation; Guidance for Industry; anyone else’s Social Security number, or considered by FDA and the Quality Availability Expert Working Group. confidential business information, such The draft guidance provides guidance AGENCY: Food and Drug Administration, as a manufacturing process. Please note on PDEs for the cutaneous and HHS. that if you include your name, contact information, or other information that transcutaneous routes of administration ACTION: Notice of availability. and relevant risk assessment identifies you in the body of your considerations to supplement previous SUMMARY: The Food and Drug comments, that information will be guidance for the oral, parenteral, and Administration (FDA or Agency) is posted on https://www.regulations.gov. • If you want to submit a comment inhalation routes of administration. In announcing the availability of a final with confidential information that you addition, error corrections to previously guidance for industry entitled ‘‘M9 do not wish to be made available to the identified PDEs for gold (oral, Biopharmaceutics Classification public, submit the comment as a parenteral, and inhalation routes), silver System-Based Biowaivers.’’ The written/paper submission and in the (parenteral route), and nickel guidance was prepared under the manner detailed (see ‘‘Written/Paper (inhalation route) are provided. auspices of the International Council for Submissions’’ and ‘‘Instructions’’). This draft guidance has been left in Harmonisation of Technical the original ICH format. The final Requirements for Pharmaceuticals for Written/Paper Submissions Human Use (ICH), formerly the guidance will be reformatted and edited Submit written/paper submissions as International Conference on to conform with FDA’s good guidance follows: Harmonisation of Technical practices regulation (21 CFR 10.115) and • Mail/Hand Delivery/Courier (for Requirements for Registration of style before publication. The draft written/paper submissions): Dockets Pharmaceuticals for Human Use. The guidance, when finalized, will represent Management Staff (HFA–305), Food and guidance provides recommendations to the current thinking of FDA on Drug Administration, 5630 Fishers support the biopharmaceutics ‘‘Q3D(R2)—Guideline for Elemental Lane, Rm. 1061, Rockville, MD 20852. Impurities.’’ It does not establish any classification of drug substances and the • For written/paper comments rights for any person and is not binding Biopharmaceutics Classification System submitted to the Dockets Management on FDA or the public. You can use an (BCS)-based waiver of the in vivo Staff, FDA will post your comment, as alternative approach if it satisfies the bioequivalence (BE) study requirement well as any attachments, except for requirements of the applicable statutes for certain drug products. The guidance information submitted, marked and and regulations. is intended to avoid or reduce the need identified, as confidential, if submitted for human BE trials based on extensive II. Paperwork Reduction Act of 1995 as detailed in ‘‘Instructions.’’ in vitro characterization of the drug Instructions: All submissions received FDA tentatively concludes that this substance and drug product properties. must include the Docket No. FDA– draft guidance contains no collection of The guidance replaces the existing FDA 2018–D–3614 for ‘‘M9 information. Therefore, clearance by the guidance issued December 26, 2017, Biopharmaceutics Classification Office of Management and Budget under entitled ‘‘Waiver of In Vivo System-Based Biowaivers.’’ Received the Paperwork Reduction Act of 1995 is Bioavailability and Bioequivalence comments will be placed in the docket not required. Studies for Immediate-Release Solid and, except for those submitted as Oral Dosage Forms Based on a III. Electronic Access ‘‘Confidential Submissions,’’ publicly Biopharmaceutics Classification viewable at https://www.regulations.gov Persons with access to the internet System.’’ The guidance also finalizes the or at the Dockets Management Staff may obtain the draft guidance at https:// draft ICH guidance, ‘‘M9 between 9 a.m. and 4 p.m., Monday www.regulations.gov, https:// Biopharmaceutics Classification through Friday, 240–402–7500. www.fda.gov/drugs/guidance- System-Based Biowaivers,’’ issued on • Confidential Submissions—To compliance-regulatory-information/ October 26, 2018. submit a comment with confidential guidances-drugs, or https:// DATES: The announcement of the information that you do not wish to be www.fda.gov/vaccines-blood-biologics/ guidance is published in the Federal made publicly available, submit your guidance-compliance-regulatory- Register on May 12, 2021. comments only as a written/paper

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submission. You should submit two Center for Drug Evaluation and committed to consistently adopting copies total. One copy will include the Research, Food and Drug these consensus-based guidelines, information you claim to be confidential Administration, 10903 New Hampshire realizing the benefits for patients and for with a heading or cover note that states Ave., Bldg. 51, Rm. 2178, Silver Spring, industry. ‘‘THIS DOCUMENT CONTAINS MD 20993–0002, 301–796–1573; or As a Founding Regulatory Member of CONFIDENTIAL INFORMATION.’’ The Stephen Ripley, Center for Biologics ICH, FDA plays a major role in the Agency will review this copy, including Evaluation and Research, Food and development of each of the ICH the claimed confidential information, in Drug Administration, 10903 New guidelines, which FDA then adopts and its consideration of comments. The Hampshire Ave., Bldg. 71, Rm. 7301, issues as guidance for industry. FDA’s second copy, which will have the Silver Spring, MD 20993–0002, 240– guidance documents do not establish claimed confidential information 402–7911. legally enforceable responsibilities. redacted/blacked out, will be available Regarding the ICH: Jill Adleberg, Instead, they describe the Agency’s for public viewing and posted on Center for Drug Evaluation and current thinking on a topic and should https://www.regulations.gov. Submit Research, Food and Drug be viewed only as recommendations, both copies to the Dockets Management Administration, 10903 New Hampshire unless specific regulatory or statutory Staff. If you do not wish your name and Ave., Bldg. 51, Rm. 6364, Silver Spring, requirements are cited. contact information to be made publicly MD 20993–0002, 301–796–5259. In the Federal Register of October 26, available, you can provide this SUPPLEMENTARY INFORMATION: 2018 (83 FR 54107), FDA published a information on the cover sheet and not I. Background notice announcing the availability of a in the body of your comments and you draft guidance entitled ‘‘M9 must identify this information as FDA is announcing the availability of Biopharmaceutics Classification ‘‘confidential.’’ Any information marked a guidance for industry entitled ‘‘M9 System-Based Biowaivers.’’ The notice as ‘‘confidential’’ will not be disclosed Biopharmaceutics Classification gave interested persons an opportunity except in accordance with 21 CFR 10.20 System-Based Biowaivers.’’ The to submit comments by January 24, and other applicable disclosure law. For guidance was prepared under the 2019. more information about FDA’s posting auspices of ICH. ICH has the mission of After consideration of the comments of comments to public dockets, see 80 achieving greater regulatory received and revisions to the guideline, harmonization worldwide to ensure that FR 56469, September 18, 2015, or access a final draft of the guideline was safe, effective, high-quality medicines the information at: https:// submitted to the ICH Assembly and are developed, registered, and www.govinfo.gov/content/pkg/FR-2015- endorsed by the regulatory agency maintained in the most resource- 09-18/pdf/2015-23389.pdf. members in November 2019. efficient manner. Docket: For access to the docket to The guidance provides read background documents or the By harmonizing the regulatory requirements in regions around the recommendations to support the electronic and written/paper comments world, ICH guidelines have biopharmaceutics classification of drug received, go to https:// substantially reduced duplicative substances and the BCS-based waiver of www.regulations.gov and insert the clinical studies, prevented unnecessary the in vivo BE study requirement for docket number, found in brackets in the animal studies, standardized the drug products. The BCS-based heading of this document, into the reporting of important safety biowaiver approach is intended to ‘‘Search’’ box and follow the prompts information, standardized marketing reduce the need for in vivo and/or go to the Dockets Management application submissions, and made bioequivalence studies. In vivo Staff, 5630 Fishers Lane, Rm. 1061, many other improvements in the quality bioequivalence studies may be waived if Rockville, MD 20852, 240–402–7500. of global drug development and an assumption of equivalence in in vivo You may submit comments on any manufacturing and the products performance can be justified by guidance at any time (see 21 CFR available to patients. satisfactory in vitro data. The BCS is a 10.115(g)(5)). The six Founding Members of the ICH scientific approach based on the Submit written requests for single are FDA; the Pharmaceutical Research aqueous solubility and intestinal copies of this guidance to the Division and Manufacturers of America; the permeability characteristics of the drug of Drug Information, Center for Drug European Commission; the European substance or substances. The BCS Evaluation and Research, Food and Federation of Pharmaceutical Industries categorizes drug substances into one of Drug Administration, 10001 New Associations; the Japanese Ministry of four BCS classes as follows: Hampshire Ave., Hillandale Building, Health, Labour, and Welfare; and the • Class I: High solubility, high 4th Floor, Silver Spring, MD 20993– Japanese Pharmaceutical Manufacturers permeability 0002, or the Office of Communication, Association. The Standing Members of • Class II: Low solubility, high Outreach and Development, Center for the ICH Association include Health permeability Biologics Evaluation and Research Canada and Swissmedic. Additionally, • Class III: High solubility, low (CBER), Food and Drug Administration, the Membership of ICH has expanded to permeability 10903 New Hampshire Ave., Bldg. 71, include other regulatory authorities and • Class IV: Low solubility, low Rm. 3128, Silver Spring, MD 20993– industry associations from around the permeability 0002. Send one self-addressed adhesive world (refer to https://www.ich.org/). In vivo BE studies are needed to label to assist that office in processing ICH works by involving technical demonstrate lack of impact of your requests. The guidance may also be experts from both regulators and significant formulation changes on a obtained by mail by calling CBER at industry parties in detailed technical drug’s bioavailability during its 1–800–835–4709 or 240–402–8010. See harmonization work and the application development, for post approval line the SUPPLEMENTARY INFORMATION section of a science-based approach to extensions, and when developing a for electronic access to the guidance harmonization through a consensus- generic product. Utilizing the critical document. driven process that results in the properties of the drug substance and the FOR FURTHER INFORMATION CONTACT: development of ICH guidelines. The drug product, and applying the BCS Regarding the guidance: Mehul Mehta, regulators around the world are framework, extensive in vitro studies

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can support the waiver of the in vivo BE DEPARTMENT OF HEALTH AND instructions for submitting comments. requirement for certain drug products. HUMAN SERVICES Comments submitted electronically, Following the public consultation including attachments, to https:// period, clarifications were made to the Food and Drug Administration www.regulations.gov will be posted to guidance based on the comments [Docket No. FDA–2018–D–4524] the docket unchanged. Because your received. comment will be made public, you are This guidance is being issued S11 Nonclinical Safety Testing in solely responsible for ensuring that your consistent with FDA’s good guidance Support of Development of Pediatric comment does not include any practices regulation (21 CFR 10.115). Pharmaceuticals; International Council confidential information that you or a The guidance represents the current for Harmonisation; Guidance for third party may not wish to be posted, thinking of FDA on ‘‘M9 Industry; Availability such as medical information, your or Biopharmaceutics Classification anyone else’s Social Security number, or System-Based Biowaivers.’’ It does not AGENCY: Food and Drug Administration, confidential business information, such establish any rights for any person and HHS. as a manufacturing process. Please note is not binding on FDA or the public. ACTION: Notice of availability. that if you include your name, contact You can use an alternative approach if information, or other information that it satisfies the requirements of the SUMMARY: The Food and Drug identifies you in the body of your applicable statutes and regulations. Administration (FDA or Agency) is comments, that information will be announcing the availability of a final II. Paperwork Reduction Act of 1995 posted on https://www.regulations.gov. guidance for industry entitled ‘‘S11 • If you want to submit a comment While this guidance contains no Nonclinical Safety Testing in Support of with confidential information that you collection of information, it does refer to Development of Pediatric do not wish to be made available to the previously approved FDA collections of Pharmaceuticals.’’ The guidance was public, submit the comment as a information. Therefore, clearance by the prepared under the auspices of the written/paper submission and in the Office of Management and Budget International Council for Harmonisation manner detailed (see ‘‘Written/Paper (OMB) under the Paperwork Reduction of Technical Requirements for Submissions’’ and ‘‘Instructions’’). Act of 1995 (PRA) (44 U.S.C. 3501– Registration of Pharmaceuticals for Written/Paper Submissions 3521) is not required. However, this Human Use (ICH), formerly the final guidance refers to previously International Conference on Submit written/paper submissions as approved FDA collections of Harmonisation of Technical follows: • information. The previously approved Requirements for Registration of Mail/Hand Delivery/Courier (for collections of information are subject to Pharmaceuticals for Human Use. The written/paper submissions): Dockets review by OMB under the PRA. The guidance recommends international Management Staff (HFA–305), Food and following collections of information standards for the nonclinical safety Drug Administration, 5630 Fishers have been approved under OMB control studies recommended to support the Lane, Rm. 1061, Rockville, MD 20852. number 0910–0001: • For written/paper comments • development of pediatric medicines. Submitting under 21 CFR 314.50 The guidance provides a weight of submitted to the Dockets Management content and format of new drug evidence approach to determine when Staff, FDA will post your comment, as applications, including the nonclinical toxicity studies may be well as any attachments, except for pharmacokinetics and bioavailability recommended in juvenile animals. If information submitted, marked and sections. identified, as confidential, if submitted • Submitting under 21 CFR 314.70 such studies are recommended, the guidance provides appropriate study as detailed in ‘‘Instructions.’’ postapproval changes. Instructions: All submissions received • Submitting under 21 CFR 314.94 designs. The guidance is intended to promote harmonization of must include the Docket No. FDA– content and format of abbreviated new 2018–D–4524 for ‘‘S11 Nonclinical drug applications. recommendations for such studies and should facilitate the timely conduct of Safety Testing in Support of The collections of information for Development of Pediatric submitting under 21 CFR 312.23 pediatric clinical trials and reduce the use of animals in accordance with the Pharmaceuticals.’’ Received comments information about pharmacokinetics will be placed in the docket and, except and biological disposition of the drug 3R (replace/reduce/refine) principles. Tissue engineered products, gene and for those submitted as ‘‘Confidential has been approved under OMB control Submissions,’’ publicly viewable at number 0910–0014. cellular therapies, and vaccines are excluded from the scope of this https://www.regulations.gov or at the III. Electronic Access guidance. The guidance replaces the Dockets Management Staff between 9 Persons with access to the internet draft guidance issued on February 1, a.m. and 4 p.m., Monday through may obtain the guidance at https:// 2019. Friday, 240–402–7500. • Confidential Submissions—To www.regulations.gov, https:// DATES: The announcement of the submit a comment with confidential www.fda.gov/Drugs/Guidance guidance is published in the Federal information that you do not wish to be ComplianceRegulatoryInformation/ Register on May 12, 2021. made publicly available, submit your Guidances/default.htm, or https:// comments only as a written/paper www.fda.gov/BiologicsBloodVaccines/ ADDRESSES: You may submit either submission. You should submit two GuidanceComplianceRegulatory electronic or written comments on copies total. One copy will include the Information/Guidances/default.htm. Agency guidances at any time as follows: information you claim to be confidential Dated: May 6, 2021. with a heading or cover note that states Lauren K. Roth, Electronic Submissions ‘‘THIS DOCUMENT CONTAINS Acting Principal Associate Commissioner for Submit electronic comments in the CONFIDENTIAL INFORMATION.’’ The Policy. following way: Agency will review this copy, including [FR Doc. 2021–09962 Filed 5–11–21; 8:45 am] • Federal eRulemaking Portal: the claimed confidential information, in BILLING CODE 4164–01–P https://www.regulations.gov. Follow the its consideration of comments. The

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second copy, which will have the Silver Spring, MD 20993–0002, 240– guidance documents do not establish claimed confidential information 402–7911. legally enforceable responsibilities. redacted/blacked out, will be available Regarding the ICH: Jill Adleberg, Instead, they describe the Agency’s for public viewing and posted on Center for Drug Evaluation and current thinking on a topic and should https://www.regulations.gov. Submit Research, Food and Drug be viewed only as recommendations, both copies to the Dockets Management Administration, 10903 New Hampshire unless specific regulatory or statutory Staff. If you do not wish your name and Ave., Bldg. 51, Rm. 6364, Silver Spring, requirements are cited. In the Federal contact information to be made publicly MD 20993–0002, 301–796–5259, Register of February 1, 2019 (84 FR available, you can provide this [email protected]. 1161), FDA published a notice information on the cover sheet and not SUPPLEMENTARY INFORMATION: announcing the availability of a draft in the body of your comments and you guidance entitled ‘‘S11 Nonclinical I. Background must identify this information as Safety Testing in Support of ‘‘confidential.’’ Any information marked FDA is announcing the availability of Development of Pediatric Medicines.’’ as ‘‘confidential’’ will not be disclosed a guidance for industry entitled ‘‘S11 The notice gave interested persons an except in accordance with 21 CFR 10.20 Nonclinical Safety Testing in Support of opportunity to submit comments by and other applicable disclosure law. For Development of Pediatric April 2, 2019. After consideration of the more information about FDA’s posting Pharmaceuticals.’’ The guidance was comments received and revisions to the of comments to public dockets, see 80 prepared under the auspices of ICH. ICH guideline, a final draft of the guideline FR 56469, September 18, 2015, or access has the mission of achieving greater was submitted to the ICH Assembly and the information at: https:// regulatory harmonization worldwide to endorsed by the regulatory agencies in www.govinfo.gov/content/pkg/FR-2015- ensure that safe, effective, high-quality April 2020. 09-18/pdf/2015-23389.pdf. medicines are developed, registered, This guidance finalizes the draft Docket: For access to the docket to and maintained in the most resource- guidance issued on February 1, 2019. read background documents or the efficient manner. By harmonizing the The guidance describes a weight of electronic and written/paper comments regulatory requirements in regions evidence approach to determine when around the world, ICH guidelines have received, go to https:// nonclinical toxicity studies may be substantially reduced duplicative www.regulations.gov and insert the recommended in juvenile animals to clinical studies, prevented unnecessary docket number, found in brackets in the support development of medicines to be animal studies, standardized the heading of this document, into the used in pediatric patients. If such reporting of important safety ‘‘Search’’ box and follow the prompts studies are recommended, the guidance information, standardized marketing and/or go to the Dockets Management also provides appropriate study designs. application submissions, and made Staff, 5630 Fishers Lane, Rm. 1061, The guidance describes study designs as many other improvements in the quality Rockville, MD 20852, 240–402–7500. consisting of a core set of endpoints that of global drug development and You may submit comments on any can be supplemented by additional manufacturing and the products guidance at any time (see 21 CFR endpoints depending on the concerns 10.115(g)(5)). available to patients. The six Founding Members of the ICH identified in the weight of evidence Submit written requests for single approach. The guidance also provides copies of this guidance to the Division are FDA; the Pharmaceutical Research and Manufacturers of America; the guidance on potential approaches for of Drug Information, Center for Drug the nonclinical support of drugs that Evaluation and Research, Food and European Commission; the European Federation of Pharmaceutical Industries will be developed only for use in Drug Administration, 10001 New Associations; the Japanese Ministry of pediatric patients or that will be first Hampshire Ave., Hillandale Building, Health, Labour, and Welfare; and the tested in pediatric patients. The 4th Floor, Silver Spring, MD 20993– Japanese Pharmaceutical Manufacturers guidance is intended to promote 0002; or the Office of Communication, Association. The Standing Members of harmonization of recommendations for Outreach and Development, Center for the ICH Association include Health such studies and should facilitate the Biologics Evaluation and Research Canada and Swissmedic. Additionally, timely conduct of pediatric clinical (CBER), Food and Drug Administration, the Membership of ICH has expanded to trials and reduce the use of animals in 10903 New Hampshire Ave., Bldg. 71, include other regulatory authorities and accordance with the 3R (replace/reduce/ Rm. 3128, Silver Spring, MD 20993– industry associations from around the refine) principles. 0002. Send one self-addressed adhesive world (refer to https://www.ich.org/). The draft guidance was revised based label to assist that office in processing ICH works by involving technical on comments received. The revisions your requests. The guidance may also be experts from both regulators and include refinement of the weight of obtained by mail by calling CBER at 1– industry parties in detailed technical evidence approach and in descriptions 800–835–4709 or 240–402–8010. See harmonization work and the application of the core and additional endpoints the SUPPLEMENTARY INFORMATION section of a science-based approach to that can be incorporated into juvenile for electronic access to the guidance harmonization through a consensus- animal studies. The final guidance also document. driven process that results in the includes a new section on data FOR FURTHER INFORMATION CONTACT: development of ICH guidelines. The interpretation. The appendices on age- Regarding the guidance: Karen Davis regulators around the world are dependent development of organ Bruno, Center for Drug Evaluation and committed to consistently adopting systems by species and preweaning Research, Food and Drug these consensus-based guidelines, litter allocation in the rodent were also Administration, 10903 New Hampshire realizing the benefits for patients and for updated. Additionally, the title of the Ave., Bldg. 22, Rm. 6428, Silver Spring, industry. guidance was updated from MD 20993–0002, 301–796–1199; or, As a Founding Regulatory Member of ‘‘Nonclinical Safety Testing in Support Stephen Ripley, Center for Biologics ICH, FDA plays a major role in the of Development of Pediatric Medicines’’ Evaluation and Research, Food and development of each of the ICH to ‘‘Nonclinical Safety Testing in Drug Administration, 10903 New guidelines, which FDA then adopts and Support of Development of Pediatric Hampshire Ave., Bldg. 71, Rm. 7301, issues as guidance for industry. FDA’s Pharmaceuticals.’’

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This guidance is being issued collections of information in FDA’s ACTION: Notice. consistent with FDA’s good guidance guidance for industry on ‘‘Expedited practices regulation (21 CFR 10.115). Programs for Serious Conditions—Drugs SUMMARY: The Food and Drug The guidance represents the current and Biologics’’ has been approved under Administration (FDA or Agency) is thinking of FDA on ‘‘S11 Nonclinical OMB control number 0910–0765. withdrawing approval of 12 abbreviated Safety Testing in Support of III. Electronic Access new drug applications (ANDAs) from Development of Pediatric multiple applicants. The applicants Persons with access to the internet Pharmaceuticals.’’ It does not establish notified the Agency in writing that the any rights for any person and is not may obtain the guidance at https:// www.regulations.gov, https:// drug products were no longer marketed binding on FDA or the public. You can and requested that the approval of the use an alternative approach if it satisfies www.fda.gov/drugs/guidance- applications be withdrawn. the requirements of the applicable compliance-regulatory-information/ statutes and regulations. guidances-drugs, or https:// DATES: Approval is withdrawn as of www.fda.gov/vaccines-blood-biologics/ June 11, 2021. II. Paperwork Reduction Act of 1995 guidance-compliance-regulatory- While this guidance contains no information-biologics/biologics- FOR FURTHER INFORMATION CONTACT: collection of information, it does refer to guidances. Martha Nguyen, Center for Drug Evaluation and Research, Food and previously approved FDA collections of Dated: May 6, 2021. Drug Administration, 10903 New information. Therefore, clearance by the Lauren K. Roth, Office of Management and Budget Hampshire Ave., Bldg. 75, Rm. 1676, Acting Principal Associate Commissioner for Silver Spring, MD 20993–0002, 240– (OMB) under the Paperwork Reduction Policy. Act of 1995 (PRA) (44 U.S.C. 3501– 402–6980, [email protected]. 3521) is not required for this guidance. [FR Doc. 2021–09964 Filed 5–11–21; 8:45 am] BILLING CODE 4164–01–P SUPPLEMENTARY INFORMATION: The previously approved collections of The information are subject to review by applicants listed in the table have OMB under the PRA. The collections of informed FDA that these drug products DEPARTMENT OF HEALTH AND are no longer marketed and have information in 21 CFR part 312, HUMAN SERVICES pertaining to the submission of requested that FDA withdraw approval of the applications under the process nonclinical and preclinical data, Food and Drug Administration including a pediatric clinical described in § 314.150(c) (21 CFR development plan, have been approved [Docket No. FDA–2021–N–0390] 314.150(c)). The applicants have also, under OMB control number 0910–0014; by their requests, waived their Lederle Laboratories et al.; Withdrawal opportunity for a hearing. Withdrawal the collections of information in 21 CFR of Approval of 12 Abbreviated New of approval of an application or part 58 pertaining to good laboratory Drug Applications practice for nonclinical laboratory abbreviated application under studies have been approved under OMB AGENCY: Food and Drug Administration, § 314.150(c) is without prejudice to control number 0910–0119; and the HHS. refiling.

Application No. Drug Applicant

ANDA 060164 ...... Nystatin Ointment ...... Lederle Laboratories, Division of American Cyanamid Co., P.O. Box 8299, Pearl River, NY 10965. ANDA 060521 ...... Humatin (paromomycin sulfate) Capsules, Equivalent to King Pharmaceuticals, 501 5th St., Bristol, TN 37620. (EQ) 250 milligrams (mg)/base. ANDA 061034 ...... Lincomycin Hydrochloride (HCl) ...... The Upjohn Co. (formerly Pharmacia and Upjohn Co.), 7000 Portage Rd., Kalamazoo, MI 49001. ANDA 061652 ...... Oxytetracycline ...... Parke Davis, 201 Tabor Rd., Morris Plains, NJ 07950. ANDA 061701 ...... Tetracycline ...... Wyeth Pharmaceuticals, 1211 Sherwood Ave., Richmond, VA 23220. ANDA 062032 ...... Erypar (erythromycin stearate) Tablets, EQ 250 mg/base Parke Davis. and EQ 500 mg/base. ANDA 076490 ...... Lithium Carbonate Extended-Release Tablets, 450 mg ..... Hikma Pharmaceuticals USA Inc., 1809 Wilson Rd., Co- lumbus, OH 43228. ANDA 083001 ...... Triamcinolone Acetonide Foam ...... Lederle Laboratories. ANDA 084803 ...... Chlorpromazine HCl Tablets, 10 mg ...... Do. ANDA 087635 ...... Butalbital; Aspirin; Phenacetin; Caffeine, Tablets ...... Do. ANDA 090102 ...... Ranitidine HCl Syrup, EQ 15 mg base/milliliters ...... Torrent Pharma Inc., 150 Allen Rd., Suite 102, Basking Ridge, NJ 07920. ANDA 206736 ...... Rifampin for Injection, 600 mg/vial ...... Watson Pharmaceuticals, Inc. (an indirect, wholly owned subsidiary of Teva Pharmaceuticals USA, Inc.), 400 Interpace Pkwy., Building A, Parsippany, NJ 07054.

Therefore, approval of the from the table. Introduction or delivery products that are listed in the table that applications listed in the table, and all for introduction into interstate are in inventory on June 11, 2021 may amendments and supplements thereto, commerce of products without continue to be dispensed until the is hereby withdrawn as of June 11, 2021. approved new drug applications inventories have been depleted or the Approval of each entire application is violates section 301(a) and (d) of the drug products have reached their withdrawn, including any strengths and Federal Food, Drug, and Cosmetic Act expiration dates or otherwise become dosage forms inadvertently missing (21 U.S.C. 331(a) and (d)). Drug violative, whichever occurs first.

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Dated: May 5, 2021. Department of Health and Human from the Working Group on Lauren K. Roth, Services, Room L616, Switzer Building, Antimicrobial Resistance (AMR) in Acting Principal Associate Commissioner for 330 C. St. SW, Washington, DC 20024. Inter-Professional Education. The Policy. Phone: 202–746–1512; Email: CARB@ remainder of the two-day public [FR Doc. 2021–09980 Filed 5–11–21; 8:45 am] hhs.gov. meeting will include an update on the BILLING CODE 4164–01–P SUPPLEMENTARY INFORMATION: The status of the antibiotic development Presidential Advisory Council on pipeline and an open council discussion Combating Antibiotic-Resistant Bacteria on provocative questions in AMR (no DEPARTMENT OF HEALTH AND (PACCARB), established by Executive recommendations will be made), in HUMAN SERVICES Order 13676, is continued by Section addition to presentations from subject matter experts on Operationalizing One Meeting of the Presidential Advisory 505 of Public Law 116–22, the Pandemic and All-Hazards Health and the Environmental Council on Combating Antibiotic- Dimensions of AMR. The meeting Resistant Bacteria Preparedness and Advancing Innovation Act of 2019 (PAHPAIA). Activities and agenda will be posted on the PACCARB AGENCY: Office of the Assistant duties of the Advisory Council are website at http://www.hhs.gov/paccarb Secretary for Health, Office of the governed by the provisions of the when it has been finalized. All agenda Secretary, Department of Health and Federal Advisory Committee Act items are tentative and subject to Human Services. (FACA), Public Law 92–463, as change. Instructions regarding attending this ACTION: Notice. amended (5 U.S.C. App.), which sets forth standards for the formation and meeting virtually will be posted one SUMMARY: As stipulated by the Federal use of federal advisory committees. week prior to the meeting at: http:// Advisory Committee Act, the The PACCARB shall advise and www.hhs.gov/paccarb. Members of the public will have the Department of Health and Human provide information and opportunity to provide comments live Services (HHS) is hereby giving notice recommendations to the Secretary during the meeting via conference line that a meeting is scheduled to be held regarding programs and policies by pre-registering online at http:// for the Presidential Advisory Council on intended to reduce or combat antibiotic- www.hhs.gov/paccarb. There will be Combating Antibiotic-Resistant Bacteria resistant bacteria that may present a two separate sessions available for (PACCARB). The meeting will be open public health threat and improve public comment: An Innovation to the public via WebEx and capabilities to prevent, diagnose, teleconference; a pre-registered public Spotlight will be held on June 29th mitigate, or treat such resistance. The comment session will be held during where companies and/or organizations PACCARB shall function solely for the meeting. Pre-registration is required involved in combating antibiotic advisory purposes. for members of the public who wish to Such advice, information, and resistance have an opportunity to attend the meeting via WebEx/ recommendations may be related to present their work to members of the teleconference. Individuals who wish to improving: The effectiveness of Advisory Council; and on June 30th, send in their written public comment antibiotics; research and advanced where all members of the general public should send an email to [email protected]. research on, and the development of, are welcome to provide oral comment Registration information is available on improved and innovative methods for during this separate session. Pre- the website http://www.hhs.gov/paccarb combating or reducing antibiotic registration is required for participation and must be completed by June 25, resistance, including new treatments, in these sessions with limited spots 2021. Additional information about rapid point-of-care diagnostics, available. Further information about registering for the meeting and alternatives to antibiotics, including these two sessions can be found online providing public comment can be alternatives to animal antibiotics, and at http://www.hhs.gov/paccarb. Written obtained at http://www.hhs.gov/paccarb antimicrobial stewardship activities; public comments can also be emailed to on the Meetings page. surveillance of antibiotic-resistant [email protected] by midnight June 25, DATES: The meeting is scheduled to be bacterial infections, including publicly 2021 and should be limited to no more held on June 29, 2021, from 10:00 a.m. available and up-to-date information on than one page. All public comments to 3:00 p.m. and June 30, 2021, from resistance to antibiotics; education for received prior to June 25, 2021, will be 10:00 a.m. to 3:00 p.m. ET (times are health care providers and the public provided to Advisory Council members. tentative and subject to change). The with respect to up-to-date information Dated: April 30, 2021. confirmed times and agenda items for on antibiotic resistance and ways to Jomana F. Musmar, the meeting will be posted on the reduce or combat such resistance to Designated Federal Officer, Presidential website for the PACCARB at http:// antibiotics related to humans and Advisory Council on Combating Antibiotic- www.hhs.gov/paccarb when this animals; methods to prevent or reduce Resistant Bacteria, Office of the Assistant information becomes available. Pre- the transmission of antibiotic-resistant Secretary for Health. registration for attending the meeting is bacterial infections; including [FR Doc. 2021–10014 Filed 5–11–21; 8:45 am] strongly suggested and should be stewardship programs; and coordination BILLING CODE 4150–44–P completed no later than June 25, 2021. with respect to international efforts in ADDRESSES: Instructions regarding order to inform and advance the United attending this meeting virtually will be States capabilities to combat antibiotic DEPARTMENT OF HEALTH AND posted one week prior to the meeting at: resistance. HUMAN SERVICES http://www.hhs.gov/paccarb. The June 29–30, 2021, public meeting FOR FURTHER INFORMATION CONTACT: will be dedicated to the council’s National Institutes of Health Jomana Musmar, M.S., Ph.D., deliberation and vote on two reports to National Institute of Mental Health; Designated Federal Officer, Presidential transmit to the Secretary of Health and Notice of Closed Meetings Advisory Council on Combating Human Services, the first from the Antibiotic-Resistant Bacteria, Office of Disparities in Antibiotics Access and Pursuant to section 10(d) of the the Assistant Secretary for Health, U.S. Use Working Group, and the second Federal Advisory Committee Act, as

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amended, notice is hereby given of the Dated: May 7, 2021. Place: National Center for Advancing following meetings. Melanie J. Pantoja, Translational Sciences, National Institutes of Health, One Democracy Plaza, 6701 The meetings will be closed to the Program Analyst, Office of Federal Advisory Democracy Boulevard, Room 987/987, public in accordance with the Committee Policy. provisions set forth in sections Bethesda, MD 20892 (Virtual Meeting). [FR Doc. 2021–10026 Filed 5–11–21; 8:45 am] Contact Person: Anna L. Ramsey-Ewing, 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., BILLING CODE 4140–01–P Ph.D., Executive Secretary, National Center as amended. The grant applications and for Advancing Translational Sciences, the discussions could disclose National Institutes of Health, One Democracy confidential trade secrets or commercial DEPARTMENT OF HEALTH AND Plaza, 6701 Democracy Boulevard, Room property such as patentable material, HUMAN SERVICES 1072, Bethesda, MD 20892, 301–435–0809, and personal information concerning [email protected]. individuals associated with the grant National Institutes of Health Attendees and interested parties may applications, the disclosure of which submit questions and comments through would constitute a clearly unwarranted National Center for Advancing written Q&A during the meeting, and for 15 invasion of personal privacy. Translational Sciences; Notice of days after the meeting, to Meeting [email protected]. Name of Committee: National Institute of Any interested person may file written Mental Health Special Emphasis Panel; Pilot Pursuant to section 10(d) of the comments with the committee by forwarding Effectiveness Trials for Treatment, Federal Advisory Committee Act, as the statement to the Contact Person listed on Prevention, and Services Interventions (R34). amended, notice is hereby given of a this notice no later than 15 days after the Date: June 8, 2021. meeting of the National Center for meeting. The statement should include the Time: 9:00 a.m. to 5:00 p.m. name, address, telephone number and when Agenda: To review and evaluate grant Advancing Translational Sciences applicable, the business or professional applications. Advisory Council. affiliation of the interested person. Place: National Institutes of Health, The meeting will be open to the (Catalogue of Federal Domestic Assistance Neuroscience Center, 6001 Executive public as indicated below. The open Program Nos. 93.859, Pharmacology, Boulevard, Rockville, MD 20852 (Telephone session will be videocast and can be Physiology, and Biological Chemistry Conference Call). accessed from the NIH Videocasting and Research; 93.350, B—Cooperative Contact Person: Serena Chu, Ph.D., Podcasting website (http://videocast. Agreements; 93.859, Biomedical Research Scientific Review Officer, Division of Extramural Activities, National Institute of nih.gov). Individuals who plan to attend and Research Training, National Institutes of Mental Health, NIH Neuroscience Center, and need special assistance, such as Health, HHS) 6001 Executive Blvd., Room 6000, MSC 9606, sign language interpretation or other Dated: May 7, 2021. Bethesda, MD 20852, 301–500–5829, reasonable accommodations, should David W. Freeman, [email protected]. notify the Contact Person listed below Program Analyst, Office of Federal Advisory Name of Committee: National Institute of in advance of the meeting. Committee Policy. Mental Health Special Emphasis Panel; The meeting will be closed to the [FR Doc. 2021–10021 Filed 5–11–21; 8:45 am] Device Development. public in accordance with the BILLING CODE 4140–01–P Date: June 9, 2021. provisions set forth in sections Time: 11:30 a.m. to 5:00 p.m. Agenda: To review and evaluate grant 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., applications. as amended. The grant applications and DEPARTMENT OF HEALTH AND Place: National Institutes of Health, the discussions could disclose HUMAN SERVICES Neuroscience Center, 6001 Executive confidential trade secrets or commercial Boulevard, Rockville, MD 20852 (Telephone property such as patentable material, National Institutes of Health Conference Call). and personal information concerning Contact Person: Nicholas Gaiano, Ph.D., individuals associated with the grant National Cancer Institute; Notice of Review Branch Chief, Division of Extramural applications, the disclosure of which Meeting Activities, National Institute of Mental Health, NIH, Neuroscience Center/Room would constitute a clearly unwarranted Pursuant to section 10(a) of the 6150/MSC 9606, 6001 Executive Boulevard, invasion of personal privacy. Federal Advisory Committee Act, as Bethesda, MD 20892–9606, 301–443–2742, Name of Committee: National Center for amended, notice is hereby given of a [email protected]. Advancing Translational Sciences Advisory meeting of the National Cancer Institute Name of Committee: National Institute of Council. Clinical Trials and Translational Mental Health Special Emphasis Panel; Mood Date: June 10–11, 2021. Research Advisory Committee. Disorders in People Living with HIV: Closed: June 10, 2021, 11:00 a.m. to 12:30 The meeting will be held as a virtual Mechanisms and Pathways (R01 & R21). p.m. Date: June 9, 2021. Agenda: To review and evaluate grant meeting and is open to the public. Time: 12:00 p.m. to 5:00 p.m. applications. Individuals who plan to view the virtual Agenda: To review and evaluate grant Place: National Center for Advancing meeting and need special assistance or applications. Translational Sciences, National Institutes of other reasonable accommodations to Place: National Institutes of Health, Health, One Democracy Plaza, 6701 view the meeting, should notify the Neuroscience Center, 6001 Executive Democracy Boulevard, Room 987/987, Contact Person listed below in advance Boulevard, Rockville, MD 20852 (Telephone Bethesda, MD 20892 (Virtual Meeting). of the meeting. The meeting will be Conference Call). Open: June 10, 2021, 1:00 p.m. to 4:00 p.m. videocast and can be accessed from the Contact Person: Rebecca Steiner Garcia, Agenda: Report from the Institute Director NIH Videocasting and Podcasting Ph.D., Scientific Review Officer, Division of and other staff. Extramural Activities, National Institute of Place: National Center for Advancing website (http://videocast.nih.gov). Mental Health, NIH, Neuroscience Center, Translational Sciences, National Institutes of Name of Committee: National Cancer 6001 Executive Blvd., Room 6149, MSC 9608, Health, One Democracy Plaza, 6701 Institute Clinical Trials and Translational Bethesda, MD 20892–9608, 301–443–4525, Democracy Boulevard, Room 987/987, Research Advisory Committee (CTAC) Ad [email protected]. Bethesda, MD 20892 (Virtual Meeting). hoc Translational Research Strategy (Catalogue of Federal Domestic Assistance Open: June 11, 2021, 1:00 p.m. to 5:00 p.m. Subcommittee. Program No. 93.242, Mental Health Research Agenda: To view and discuss Clearance of Date: June 17, 2021. Grants, National Institutes of Health, HHS) Concepts. Time: 11:00 a.m. to 12:00 p.m.

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Agenda: Group Discussion of Social Psychology, Personality and Contact Person: C–L Albert Wang, Ph.D., Opportunities and Gaps in Translational Interpersonal Processes Study Section. Scientific Review Officer, Center for Research. Date: June 10–11, 2021. Scientific Review, National Institutes of Place: National Cancer Institute, Shady Time: 9:00 a.m. to 8:00 p.m. Health, 6701 Rockledge Drive, Room 4146, Grove, 9609 Medical Center Drive, Rockville, Agenda: To review and evaluate grant MSC 7806, Bethesda, MD 20892, 301–435– MD 20850 (Virtual Meeting). applications. 1016, [email protected]. Contact Person: Peter Ujhazy, M.D., Ph.D., Place: National Institutes of Health, Name of Committee: Surgical Sciences, Deputy Associate Director, Translational Rockledge II, 6701 Rockledge Drive, Biomedical Imaging and Bioengineering Research Program, Division of Cancer Bethesda, MD 20892 (Virtual Meeting). Integrated Review Group; Surgery, Treatment and Diagnosis, National Cancer Contact Person: Shalanda A. Bynum, Anesthesiology and Trauma Study Section. Institute, National Institutes of Health, 9609 Ph.D., Scientific Review Officer, Center for Date: June 15–16, 2021. Medical Center Drive, Room 3W106, Scientific Review, National Institutes of Time: 9:30 a.m. to 8:00 p.m. Rockville, MD 20850, 240–276–5681, Health, 6701 Rockledge Drive, Room 3206, Agenda: To review and evaluate grant [email protected]. Bethesda, MD 20892, 301–755–4355, applications. Any interested person may file written [email protected]. Place: National Institutes of Health, comments with the committee by forwarding Name of Committee: Center for Scientific Rockledge II, 6701 Rockledge Drive, the statement to the Contact Person listed on Review Special Emphasis Panel; Bethesda, MD 20892 (Virtual Meeting). this notice. The statement should include the Neuroimmunology and Brain Tumors. Contact Person: Weihua Luo, MD, Ph.D., name, address, telephone number and when Date: June 10, 2021. Scientific Review Officer, Center for applicable, the business or professional Time: 10:00 a.m. to 3:00 p.m. Scientific Review, National Institutes of affiliation of the interested person. Agenda: To review and evaluate grant Health, 6701 Rockledge Drive, Room 5114, Information is also available on the applications. MSC 7854, Bethesda, MD 20892, (301) 435– Institute’s/Center’s home page: https:// Place: National Institutes of Health, 6701 1170, [email protected]. Rockledge Drive, Bethesda, MD 20892 deainfo.nci.nih.gov/advisory/ctac/ Name of Committee: Digestive, Kidney and (Virtual Meeting). subcommittees/index.htm, where an agenda Urological Systems Integrated Review Group; Contact Person: Samuel C. Edwards, Ph.D., and any additional information for the Kidney and Urological Systems Function and Chief, Brain Disorders and Clinical meeting will be posted when available. Dysfunction Study Section. Neuroscience, Center for Scientific Review, Date: June 17–18, 2021. (Catalogue of Federal Domestic Assistance National Institutes of Health, 6701 Rockledge Time: 8:00 a.m. to 8:00 p.m. Program Nos. 93.392, Cancer Construction; Drive, Room 5210, MSC 7846, Bethesda, MD Agenda: To review and evaluate grant 93.393, Cancer Cause and Prevention 20892, (301) 435–1246, edwardss@ applications. Research; 93.394, Cancer Detection and csr.nih.gov. Diagnosis Research; 93.395, Cancer Place: National Institutes of Health, Treatment Research; 93.396, Cancer Biology Name of Committee: Center for Scientific Rockledge II, 6701 Rockledge Drive, Review Special Emphasis Panel; Research; 93.397, Cancer Centers Support; Bethesda, MD 20892 (Virtual Meeting). Fellowships: Neurodevelopment, Synaptic 93.398, Cancer Research Manpower; 93.399, Contact Person: Ganesan Ramesh, Ph.D., Plasticity and Neurodegeneration. Cancer Control, National Institutes of Health, Scientific Review Officer, Center for Date: June 14–15, 2021. HHS) Scientific Review, National Institutes of Time: 9:00 a.m. to 7:00 p.m. Health, 6701 Rockledge Drive, Room 2182, Dated: May 7, 2021. Agenda: To review and evaluate grant MSC 7818, Bethesda, MD 20892, 301–827– Melanie J. Pantoja, applications. 5467, [email protected]. Place: National Institutes of Health, Program Analyst, Office of Federal Advisory Name of Committee: Surgical Sciences, Committee Policy. Rockledge II, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting). Biomedical Imaging and Bioengineering [FR Doc. 2021–10027 Filed 5–11–21; 8:45 am] Contact Person: Tina Tze-Tsang Tang, Integrated Review Group; Imaging BILLING CODE 4140–01–P Ph.D., Scientific Review Officer, Center for Technology Development Study Section. Scientific Review, National Institutes of Date: June 17–18, 2021. Health, 6701 Rockledge Drive, Suite 3030, Time: 9:00 a.m. to 8:00 p.m. DEPARTMENT OF HEALTH AND Bethesda, MD 20817, (301) 435–4436, tangt@ Agenda: To review and evaluate grant HUMAN SERVICES mail.nih.gov. applications. Place: National Institutes of Health, Name of Committee: Center for Scientific Rockledge II, 6701 Rockledge Drive, National Institutes of Health Review Special Emphasis Panel; Membrane Bethesda, MD 20892 (Virtual Meeting). Biology and Protein Processing. Contact Person: Ileana Hancu, Ph.D., Center for Scientific Review; Notice of Date: June 14, 2021. Scientific Review Officer, Center for Time: 10:00 a.m. to 7:00 p.m. Closed Meetings Scientific Review, National Institutes of Agenda: To review and evaluate grant Health, 6701 Rockledge Drive, Room 5116, Pursuant to section 10(d) of the applications. Bethesda, MD 20817, 301–402–3911, Federal Advisory Committee Act, as Place: National Institutes of Health, [email protected]. amended, notice is hereby given of the Rockledge II, 6701 Rockledge Drive, following meetings. Bethesda, MD 20892 (Virtual Meeting). Name of Committee: Center for Scientific The meetings will be closed to the Contact Person: Maqsood A. Wani, Ph.D., Review Special Emphasis Panel; Lifestyle Change and Behavioral Health. public in accordance with the Scientific Review Officer, Center for Scientific Review, National Institutes of Date: June 17, 2021. provisions set forth in sections Health, 6701 Rockledge Drive, Room 2114, Time: 9:30 a.m. to 8:00 p.m. 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., MSC 7814, Bethesda, MD 20892, 301–435– Agenda: To review and evaluate grant as amended. The grant applications and 2270, [email protected]. applications. the discussions could disclose Name of Committee: Biological Chemistry Place: National Institutes of Health, confidential trade secrets or commercial and Macromolecular Biophysics Integrated Rockledge II, 6701 Rockledge Drive, property such as patentable material, Review Group; Macromolecular Structure Bethesda, MD 20892 (Virtual Meeting). and personal information concerning and Function B Study Section. Contact Person: Weijia Ni, Ph.D., MA, BA, individuals associated with the grant Date: June 15–16, 2021. Chief/Scientific Review Officer, Center for Time: 9:00 a.m. to 8:00 p.m. Scientific Review, National Institutes of applications, the disclosure of which Health, 6701 Rockledge Drive, Room 3100, would constitute a clearly unwarranted Agenda: To review and evaluate grant applications. MSC 7808, Bethesda, MD 20892, (301) 594– invasion of personal privacy. Place: National Institutes of Health, 3292, [email protected]. Name of Committee: Risk, Prevention and Rockledge II, 6701 Rockledge Drive, Name of Committee: Infectious Diseases Health Behavior Integrated Review Group; Bethesda, MD 20892 (Virtual Meeting). and Immunology B Integrated Review Group;

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Hypersensitivity, Autoimmune, and Immune- ES–2020–0098; U.S. Fish and Wildlife coastal and inland staging areas and an mediated Diseases Study Section. Service Headquarters, MS: PRB/3W; ample supply of other coastal and Date: June 17–18, 2021. 5275 Leesburg Pike; Falls Church, VA inland stopover habitats distributed Time: 10:00 a.m. to 9:00 p.m. Agenda: To review and evaluate grant 22041–3803. across the range. In the final listing rule applications. For more information, see Availability published on December 12, 2014 (79 FR Place: National Institutes of Health, of Public Comments under 73705), the Service determined that the Rockledge II, 6701 Rockledge Drive, SUPPLEMENTARY INFORMATION. rufa red knot is threatened under the Bethesda, MD 20892 (Virtual Meeting). FOR FURTHER INFORMATION CONTACT: Eric ESA due to the following primary Contact Person: Deborah Hodge, Ph.D., Schrading, Field Supervisor by phone at threats: Loss of breeding and Scientific Review Officer, Center for _ Scientific Review, National Institutes of 609–382–5272, via email at eric nonbreeding habitat (including sea level Health, 6701 Rockledge Drive, Room 4207, [email protected], or via the Federal rise, coastal engineering, coastal MSC 7812, Bethesda, MD 20892, (301) 435– Relay Service at 800–877–8339. development, and arctic ecosystem 1238, [email protected]. SUPPLEMENTARY INFORMATION: We, the change); likely effects related to (Catalogue of Federal Domestic Assistance U.S. Fish and Wildlife Service (Service), disruption of natural predator cycles on Program Nos. 93.306, Comparative Medicine; announce the availability of the draft the breeding grounds; reduced prey 93.333, Clinical Research, 93.306, 93.333, recovery plan for the threatened rufa red availability throughout the nonbreeding 93.337, 93.393–93.396, 93.837–93.844, 93.846–93.878, 93.892, 93.893, National knot (Calidris canutus rufa) for public range; and increasing frequency and Institutes of Health, HHS) review and comment. The draft recovery severity of asynchronies (mismatches) plan includes objective, measurable in the timing of the birds’ annual Dated: May 7, 2021. criteria and management actions as may migratory cycle relative to favorable Melanie J. Pantoja, be necessary for removal of the species food and weather conditions. Refer to Program Analyst, Office of Federal Advisory from the Federal List of Endangered and Committee Policy. the Species Status Assessment Report Threatened Wildlife. We request review (USFWS 2020) for a full discussion of [FR Doc. 2021–10020 Filed 5–11–21; 8:45 am] and comment on this draft recovery the species’ biology and threats. BILLING CODE 4140–01–P plan from local, State, and Federal agencies, and the public. Recovery Strategy

DEPARTMENT OF THE INTERIOR Recovery Planning The recovery strategy is to prevent Section 4(f) of the Endangered Species loss of the rufa red knot’s adaptive Fish and Wildlife Service Act of 1973, as amended (Act; 16 U.S.C. capacity by maintaining representation [Docket No. FWS–R5–ES–2020–0098; 1531 et seq.), requires the development within and among four Recovery Units, FXES11130500000–212–FF05E00000] of recovery plans for listed species, and improving their resiliency and unless such a plan would not promote redundancy. Recovery efforts will focus Endangered and Threatened Wildlife the conservation of a particular species. on protecting, restoring, maintaining, and Plants; Draft Recovery Plan for the Also pursuant to section 4(f) of the Act, and managing important nonbreeding Rufa Red Knot a recovery plan must, to the maximum habitats for adults and juveniles. Recovery actions will directly abate AGENCY: Fish and Wildlife Service, extent practicable, include (1) a Interior. description of site-specific management threats to red knots in their wintering actions as may be necessary to achieve and migration ranges, and will also ACTION: Notice of availability and the plan’s goals for the conservation and request for public comment. increase resiliency of populations to survival of the species; (2) objective, withstand threats that stem from climate SUMMARY: We, the U.S. Fish and measurable criteria that, when met, change in their Arctic breeding range Wildlife Service, announce the would support a determination under and elsewhere. These actions include availability of the draft recovery plan for section 4(a)(1) that the species should be monitoring and safeguarding ample food rufa red knot, a bird subspecies listed as removed from the List of Endangered supplies; preventing impacts from threatened under the Endangered and Threatened Species; and (3) development and shoreline Species Act. We request review and estimates of the time and costs required stabilization; managing human comment on this draft recovery plan to carry out those measures needed to disturbance; and restoring key habitats. from local, State, and Federal agencies, achieve the plan’s goal. They may also include land acquisition, and the public. Species Background facilitated migration of certain beaches DATES: We must receive comments by or tidal flats, and restoring natural July 12, 2021. The rufa red knot is a medium-sized, coastal processes that create and highly migratory shorebird that ranges ADDRESSES: maintain red knot habitat. Document availability: The draft across nearly the full latitude gradient of recovery plan, along with any comments the Western Hemisphere. This Availability of Public Comments and other materials that we receive, will subspecies is among the longest- Before including your address, phone be available for public inspection at distance migrants in the animal number, email address, or other http://www.regulations.gov in Docket kingdom, and among the best-studied No. FWS–R5–ES–2020–0098. shorebirds in the world. Rufa red knots personal identifying information in your Submitting Comments: You may migrate annually between their breeding comment, you should be aware that submit comments by one of the grounds on the central Canadian arctic your entire comment—including your following methods: tundra and four wintering regions that personal identifying information—may • Internet: http:// include the Atlantic coasts of Argentina be made publicly available at any time. www.regulations.gov. Search for and and Chile, the northern coast of South While you can ask us in your comment submit comments on Docket No. FWS– America, the western Gulf of Mexico, to withhold your personal identifying R5–ES–2020–0098. and the southeast United States and the information from public review, we • U.S. Mail: Public Comments Caribbean. During migration, rufa red cannot guarantee that we will be able to Processing, Attn: Docket No. FWS–R5– knots require a reliable network of do so.

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Authority Submitting Written Comments: Please issue permits to authorize take of listed The authority for this action is section send us your written comments using fish and wildlife species that is one of the following methods: incidental to, and not the purpose of, 4(f) of the Endangered Species Act, 16 • U.S.C. 1533(f). U.S. mail: Stephen P. Henry, Field carrying out an otherwise lawful Supervisor, Ventura Fish and Wildlife activity. Regulations governing Sharon Marino, Office, U.S. Fish and Wildlife Service, incidental take permits for endangered Assistant Regional Director, Ecological 2493 Portola Road, Suite B, Ventura, CA species are in the Code of Federal Services, North Atlantic—Appalachian 93003. Regulations (CFR) at 50 CFR 17.22. Region. • Email: [email protected]. Issuance of an ITP also must not [FR Doc. 2021–10064 Filed 5–11–21; 8:45 am] FOR FURTHER INFORMATION CONTACT: jeopardize the existence of federally BILLING CODE 4333–15–P Rachel Henry, Fish and Wildlife listed fish, wildlife, or plant species, Biologist, by email, via the Federal pursuant to section 7 of the ESA and 50 Relay Service at 1–800–877–8339 for CFR 402.02. The permittee would DEPARTMENT OF THE INTERIOR TTY assistance, or by mail at the receive assurances under our ‘‘No Fish and Wildlife Service Ventura address (see ADDRESSES). Surprises’’ regulations (50 CFR SUPPLEMENTARY INFORMATION: We, the 17.22(b)(5)). [FWS–R8–ES–2020–N110; FXES11140800000–201–FF08EVEN00] U.S. Fish and Wildlife Service (Service), Proposed Activities announce the availability of a draft Endangered and Threatened Wildlife habitat conservation plan (HCP) and The applicant has applied for a permit and Plants; Draft Habitat Conservation draft categorical exclusion (CatEx) with for incidental take of the Santa Barbara Plan and Draft Categorical Exclusion an application for an incidental take County DPS of the California tiger for the Santa Barbara County Distinct permit (ITP) by Pacific Coast Energy salamander. The take would occur in Population Segment of the California Company, LLC (applicant). The ITP association with the operation and Tiger Salamander; Orcutt Hill Resource would authorize take of the federally maintenance of existing ongoing oil and Solar Project, Pacific Coast endangered Santa Barbara County production facilities and installation, Energy Company, Santa Barbara distinct population segment (DPS) of the operation, and maintenance of a solar County, California California tiger salamander (Ambystoma photovoltaic system. californiense) incidental to activities The HCP includes avoidance and AGENCY: Fish and Wildlife Service, described in the HCP for activities Interior. minimization measures for the Santa associated with the operation and Barbara County DPS of the California ACTION: Notice of availability; request maintenance of existing ongoing oil tiger salamander and mitigation for for comments. production facilities and operations; the unavoidable loss of habitat. As maintenance and management of 101 SUMMARY: We, the U.S. Fish and mitigation for habitat loss, the applicant seep cans; the installation, maintenance, Wildlife Service (Service), announce the proposes to establish a conservation and management of future seep cans; availability of a draft habitat easement within an area that is known and the installation, operation, and conservation plan (HCP) and draft to support the Santa Barbara County maintenance of a solar photovoltaic categorical exclusion (CatEx) for DPS of the California tiger salamander system near the City of Orcutt in Santa activities described in an application for or purchase credits from a Service- Barbara County, California. The an incidental take permit (ITP) under approved mitigation bank. applicant developed a draft HCP as part the Endangered Species Act of 1973, as of the application for an ITP under Public Availability of Comments amended. The ITP would authorize take section 10(a)(1)(B) of the Endangered of the Santa Barbara County distinct Species Act of 1973, as amended (ESA; Before including your address, phone population segment of the California 16 U.S.C. 1531 et seq.). The Service number, email address, or other tiger salamander incidental to activities prepared a draft CatEx in accordance personal identifying information in your associated with oil production facilities with the National Environmental Policy comment, you should be aware that and a solar photovoltaic system near the Act of 1969 (NEPA; 42 U.S.C. 4321 et your entire comment, including your city of Orcutt in Santa Barbara County, seq.) to evaluate the potential effects to personal identifying information, may California. The applicant developed the the natural and human environment be made publicly available at any time. draft HCP as part of their application for resulting from issuing an ITP to the While you can ask us in your comment an ITP. The Service prepared a draft applicant. We invite public comment on to withhold your personal identifying CatEx in accordance with the National these documents. information from public view, we Environmental Policy Act to evaluate cannot guarantee that we will be able to the potential effects to the natural and Background do so. human environment resulting from The Service listed the Santa Barbara Authority issuing an ITP to the applicant. We County DPS of the California tiger invite public comment on these salamander as endangered on We provide this notice under section documents. September 21, 2000 (65 FR 57242). 10(c) of the ESA (16 U.S.C. 1531 et seq.) DATES: Written comments should be Section 9 of the ESA prohibits take of and its implementing regulations (50 received on or before June 11, 2021. fish and wildlife species listed as CFR 17.22) and NEPA (42 U.S.C. 4321 ADDRESSES: endangered (16 U.S.C. 1538). Under the et seq.) and its implementing Obtaining Documents: You may ESA, ‘‘take’’ is defined to include the regulations (40 CFR 1506.6). download a copy of the draft HCP and following activities: ‘‘to harass, harm, draft CatEx at http://www.fws.gov/ pursue, hunt, shoot, wound, kill, trap, Stephen Henry, ventura/, or you may request copies of capture, or collect, or to attempt to Field Supervisor, Ventura Fish and Wildlife the documents by U.S. mail (below) or engage in any such conduct’’ (16 U.S.C. Office, Ventura, California. by email (see FOR FURTHER INFORMATION 1532). Under section 10(a)(1)(B) of the [FR Doc. 2021–10045 Filed 5–11–21; 8:45 am] CONTACT). ESA (16 U.S.C. 1539(a)(1)(B)), we may BILLING CODE 4333–15–P

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INTERNATIONAL TRADE International Trade Commission prohibition or suppression of speech or COMMISSION Building, 500 E Street SW, Washington, other forms of communication,’’ and DC. All written submissions should be stated that foreign governments use [Investigation No. 332–585] submitted electronically and addressed many tools to carry out censorship, Foreign Censorship Part 1: Policies to the Secretary, U.S. International including technological measures that and Practices Affecting U.S. Trade Commission, 500 E Street SW, restrict digital trade. The Committee Businesses and Investigation No. 332– Washington, DC 20436. The public said that these tools, and the policies 586: Foreign Censorship Part 2: Trade record for this investigation may be that enable them, allow authorities in and Economic Effects on U.S. viewed on the Commission’s electronic foreign markets to limit speech by Businesses docket (EDIS) at https://edis.usitc.gov. controlling the flow of information and FOR FURTHER INFORMATION CONTACT: services. AGENCY: United States International Project Leader Isaac Wohl (202–205– In response to the Committee’s letter Trade Commission. 3356 or [email protected]), or received on April 8, 2021, the ACTION: Change in title, scope, and Deputy Project Leader Jean Yuan (202– Commission has changed the title of the schedule of Investigation No. 332–585 205–2383 or [email protected]) for report in Investigation No. 332–585, to and institution of Investigation No. 332– information specific to Investigation No. Foreign Censorship Part 1: Policies and 586 to address trade and economic 332–585. Project Leader Ricky Ubee Practices Affecting U.S. Businesses, and effects of foreign censorship on U.S. (202–205–3493 or ravinder.ubee@ it has changed the delivery date for this businesses. usitc.gov), Deputy Project Leader Shova first report to December 30, 2021. The KC (202–205–2234 or shova.kc@ first report will contain detailed SUMMARY: Following receipt of a letter usitc.gov), or Deputy Project Leader information on the following: from the U.S. Senate Committee on George Serletis (202–205–3315 or 1. Identification and descriptions of Finance (Committee) on April 8, 2021, [email protected]) for various foreign censorship practices, in under section 332(g) of the Tariff Act of information specific to Investigation No. particular any examples that U.S. 1930, the Commission has changed the 332–586. For information on the legal businesses consider to impede trade or title, scope, and schedule, including the aspects of these investigations, contact investment in key foreign markets. The hearing date, for Investigation No. 332– William Gearhart of the Commission’s description should include to the extent 585, with the investigation to be retitled Office of the General Counsel (202–205– practicable: Foreign Censorship Part 1: Policies and 3091 or [email protected]). a. The evolution of censorship Practices Affecting U.S. Businesses. The The media should contact Margaret policies and practices over the past 5 Commission has also instituted a second O’Laughlin, Office of External Relations years in key foreign markets; Investigation in response to the letter, (202–205–1819 or margaret.olaughlin@ b. any elements that entail Investigation No. 332–586, Foreign usitc.gov). Hearing-impaired individuals extraterritorial censorship; and Censorship Part 2: Trade and Economic may obtain information on this matter c. the roles of governmental and non- Effects on U.S. Businesses. The public by contacting the Commission’s TDD governmental actors in implementation hearing has been rescheduled to July 1, terminal at 202–205–1810. General and enforcement of the practices. 2021 and will be in conjunction with information concerning the Commission In response to the request for the both investigations. The hearing will be may also be obtained by accessing its second report, the Commission has conducted via an online website (https://www.usitc.gov). instituted Investigation No. 332–586, videoconferencing platform. Dates SUPPLEMENTARY INFORMATION: The Foreign Censorship Part 2: Trade and relating to written submissions have Committee’s new letter received on Economic Effects on U.S. Businesses. been adjusted accordingly. April 8, 2021 modified its earlier letter The Commission will deliver the second DATES: of January 4, 2021 in three principal report by July 5, 2022. The second June 17, 2021: Deadline for filing ways: (1) It calls for two reports instead report will provide: requests to appear at the public hearing. of one, with the first report to focus on 2. To the extent practicable, including June 18, 2021: Deadline for filing policies and practices affecting U.S. through the use of survey data, an prehearing briefs and statements. businesses, and a second to focus on analysis of the trade and economic June 24, 2021: Deadline for filing trade and economic effects on U.S. effects of such policies and practices on electronic copies of oral hearing businesses, based in part on a affected businesses in the United States statements. Commission survey; (2) it defines the and their global operations. The analysis July 1, 2021: Public hearing. scope of the investigations by indicating should include to the extent practicable, July 12, 2021: Deadline for filing which elements of the original request quantitative and qualitative impacts of posthearing briefs and statements. letter should be addressed in the first the identified policies, including by July 22, 2021: Deadline for filing all and second reports, respectively; and (3) reference, where identifiable, to: other written submissions for it provides a new delivery date for the a. Impact on employment; Investigation No. 332–585. first report (December 30, 2021) and sets b. direct costs (e.g., compliance and December 30, 2021: Transmittal of a later delivery date for the second entry costs); Commission’s Part 1 report to the report (July 5, 2022). As in the January c. foregone revenue and sales; Committee. 4, 2021, letter, the Committee requested d. self-censorship; and January 14, 2022: Deadline for filing the investigations and reports pursuant e. other effects the Commission all other written submissions for to section 332(g) of the Tariff Act of considers relevant for the Committee to Investigation No. 332–586. 1930 (19 U.S.C. 1332(g)). The know. July 5, 2022: Transmittal of Commission published the initial notice In view of the fact the Committee Commission’s Part 2 report to the of Investigation No. 332–585 in the intends to make these reports available Committee. Federal Register of January 29, 2021 (86 to the public in their entirety, the ADDRESSES: All Commission offices, FR 7559). Commission will not include any including the Commission’s hearing As in the original letter, the confidential business information in its rooms, are located in the U.S. Committee defined censorship as ‘‘the reports.

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Public Hearing: A public hearing in submissions specific to Investigation the hearing, (c) should clarify, amplify, connection with both investigations will No. 332–586, Foreign Censorship Part 2: or correct any statements you made at be held via an online videoconferencing Trade and Economic Effects on U.S. the hearing, and (d) may, at your option, platform, beginning at 9:30 a.m. on July Businesses, should be received not later address or rebut statements made by 1, 2021. This hearing replaces the than 5:15 p.m., January 14, 2022. All other participants in the hearing. previously announced hearing in written submissions must conform to (4) Other written submissions refers to connection with Investigation No. 332– the provisions of section 201.8 of the any other written submissions that 585, scheduled for September 14, 2021. Commission’s Rules of Practice and interested persons wish to make, Information about how to participate in Procedure (19 CFR 201.8), as regardless of whether they appeared at or view the hearing will be posted on temporarily amended by 85 FR 15798 the hearing, and may include new the Commission’s website at (https:// (March 19, 2020). Under that rule information or updates of information usitc.gov/research_and_analysis/what_ waiver, the Office of the Secretary will previously provided. we_are_working_on.htm). Once on that accept only electronic filings at this There is no standard format that briefs web page, scroll down to either entry for time. Filings must be made through the or other written submissions must Investigation No. 332–585, Foreign Commission’s Electronic Document follow. However, each such document Censorship Part 1: Policies and Information System (EDIS, https:// must identify on its cover (1) the Practices Affecting U.S. Businesses or edis.usitc.gov). No in-person paper- investigation number and title and the Investigation No. 332–586, Foreign based filings or paper copies of any type of document filed (i.e., prehearing Censorship Part 2: Trade and Economic electronic filings will be accepted until brief, oral statement of (name), Effects on U.S. Businesses and click on further notice. Persons with questions posthearing brief, or written the link to ‘‘Hearing Instructions.’’ regarding electronic filing should submission), (2) the name of the person Interested parties should check the contact the Office of the Secretary, or organization filing it, and (3) whether Commission’s website periodically for Docket Services Division (202–205– it contains confidential business updates. 1802), or consult the Commission’s information (CBI). If it contains CBI, it Requests to appear at the public Handbook on Filing Procedures. must comply with the marking and hearing should be filed electronically Definitions of Types of Documents other requirements set out below in this with the Secretary no later than 5:15 That May Be Filed; Requirements: In notice relating to CBI. Submitters of p.m., June 17, 2021, in accordance with addition to requests to appear at the written documents (other than oral the requirements in the ‘‘Written hearing, this notice provides for the hearing statements) are encouraged to Submissions’’ section below. All possible filing of four types of include a short summary of their prehearing briefs and statements should documents: Prehearing briefs, oral position or interest at the beginning of be filed electronically not later than 5:15 hearing statements, posthearing briefs, the document, and a table of contents p.m., June 18, 2021. To facilitate the and other written submissions. when the document addresses multiple hearing, including the preparation of an (1) Prehearing briefs refers to written issues. accurate written transcript of the materials relevant to the investigation Confidential Business Information: hearing, oral testimony to be presented and submitted in advance of the Any submissions that contain at the hearing must be submitted to the hearing, and includes written views on confidential business information must Commission electronically no later than matters that are the subject of the also conform to the requirements of noon, June 24, 2021. All posthearing investigation, supporting materials, and section 201.6 of the Commission’s Rules briefs and statements should be filed any other written materials that you of Practice and Procedure (19 CFR electronically not later than 5:15 p.m., consider will help the Commission in 201.6). Section 201.6 of the rules July 12, 2021. Posthearing briefs and understanding your views. You should requires that the cover of the document statements should address matters file a prehearing brief particularly if you and the individual pages be clearly raised at the hearing. For a description plan to testify at the hearing on behalf marked as to whether they are the of the different types of written briefs of an industry group, company, or other ‘‘confidential’’ or ‘‘non-confidential’’ and statements, see the ‘‘Definitions’’ organization, and wish to provide version, and that the confidential section below. detailed views or information that will business information is clearly In the event that, as of the close of support or supplement your testimony. identified by means of brackets. All business on June 17, 2021, no witnesses (2) Oral hearing statements written submissions, except for are scheduled to appear at the hearing, (testimony) refers to the actual oral confidential business information, will the hearing will be canceled. Any statement that you intend to present at be made available for inspection by person interested in attending the the public hearing. Do not include any interested parties. hearing as an observer or nonparticipant confidential business information in As requested by the Committee on should contact the Office of the that statement. If you plan to testify, you Finance, the Commission will not Secretary at 202–205–2000 after June 17, must file a copy of your oral statement include any confidential business 2021, for information concerning by the date specified in this notice. This information in its report. However, all whether the hearing will be held. statement will allow Commissioners to information, including confidential Written Submissions: In lieu of or in understand your position in advance of business information, submitted in this addition to participating in the hearing, the hearing and will also assist the court investigation may be disclosed to and interested parties are invited to file, reporter in preparing an accurate used: (i) By the Commission, its electronically, written submissions transcript of the hearing (e.g., names employees and Offices, and contract concerning these investigations. All spelled correctly). personnel (a) for developing or written submissions should be (3) Posthearing briefs refers to maintaining the records of this or a addressed to the Secretary. Written submissions filed after the hearing by related proceeding, or (b) in internal submissions specific to Investigation persons who appeared at the hearing. investigations, audits, reviews, and No. 332–585, Foreign Censorship Part 1: Such briefs: (a) Should be limited to evaluations relating to the programs, Policies and Practices Affecting U.S. matters that arose during the hearing, (b) personnel, and operations of the Businesses, should be received not later should respond to any Commissioner Commission including under 5 U.S.C. than 5:15 p.m., July 22, 2021. Written and staff questions addressed to you at Appendix 3; or (ii) by U.S. government

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employees and contract personnel for Commission’s Rules of Practice and Proposed respondents, other cybersecurity purposes. The Procedure. interested parties, and members of the Commission will not otherwise disclose public are invited to file comments on any confidential business information in FOR FURTHER INFORMATION CONTACT: Lisa any public interest issues raised by the a way that would reveal the operations R. Barton, Secretary to the Commission, complaint or § 210.8(b) filing. of the firm supplying the information. U.S. International Trade Commission, Comments should address whether 500 E Street SW, Washington, DC Summaries of Written Submissions: issuance of the relief specifically 20436, telephone (202) 205–2000. The Persons wishing to have a summary of requested by the complainant in this public version of the complaint can be their position included in the first investigation would affect the public accessed on the Commission’s report should include a summary with health and welfare in the United States, Electronic Document Information their written submission on or before competitive conditions in the United System (EDIS) at https://edis.usitc.gov. July 22, 2021 and should mark the States economy, the production of like For help accessing EDIS, please email summary as having been provided for or directly competitive articles in the [email protected]. that purpose. The summary should be United States, or United States clearly marked as ‘‘summary for General information concerning the consumers. inclusion in the part 1 report’’ at the top Commission may also be obtained by In particular, the Commission is of the page. Persons wishing to have a accessing its internet server at United interested in comments that: summary of their position included in States International Trade Commission (i) Explain how the articles the second report should include a (USITC) at https://www.usitc.gov. The potentially subject to the requested summary with their written submission public record for this investigation may remedial orders are used in the United on or before January 14, 2022 and be viewed on the Commission’s States; (ii) identify any public health, safety, should mark the summary as having Electronic Document Information or welfare concerns in the United States been provided for that purpose. The System (EDIS) at https://edis.usitc.gov. relating to the requested remedial summary should be clearly marked as Hearing-impaired persons are advised orders; ‘‘summary for inclusion in the part 2 that information on this matter can be (iii) identify like or directly report’’ at the top of the page. obtained by contacting the competitive articles that complainant, The summary may not exceed 500 Commission’s TDD terminal on (202) 205–1810. its licensees, or third parties make in the words, should be in MS Word format or United States which could replace the a format that can be easily converted to SUPPLEMENTARY INFORMATION: The subject articles if they were to be MS Word, and should not include any Commission has received a complaint excluded; confidential business information. The and a submission pursuant to § 210.8(b) (iv) indicate whether complainant, summary will be published as provided of the Commission’s Rules of Practice complainant’s licensees, and/or third if it meets these requirements and is and Procedure filed on behalf of CAB party suppliers have the capacity to germane to the subject matter of the Enterprises, Inc. and Sueros y Bebidas replace the volume of articles investigation. The Commission will list Rehidratantes S.A. de C.V. on May 6, potentially subject to the requested the name of the organization furnishing 2021. The complaint alleges violations exclusion order and/or a cease and the summary and will include a link to of section 337 of the Tariff Act of 1930 desist order within a commercially the Commission’s Electronic Document (19 U.S.C. 1337) in the importation into reasonable time; and Information System (EDIS) where the the United States, the sale for (v) explain how the requested written submission can be found. importation, and the sale within the remedial orders would impact United By order of the Commission. United States after importation of States consumers. Issued: May 6, 2021. certain electrolyte containing beverages Written submissions on the public Lisa Barton, and labeling and packaging thereof. The interest must be filed no later than by complainant names as respondents: close of business, eight calendar days Secretary to the Commission. Flexicompuestos S.A. de C.V. of after the date of publication of this [FR Doc. 2021–09991 Filed 5–11–21; 8:45 am] Mexico; Grupo Comercial Lux del Norte notice in the Federal Register. There BILLING CODE 7020–02–P S.A. de C.V. of Mexico; Carbonera Los will be further opportunities for Asadores S.A. de C.V. of Mexico; Caribe comment on the public interest after the Agencia Express, S.A. de C.V. of INTERNATIONAL TRADE issuance of any final initial Mexico; Comercializadora Degu S.A. de COMMISSION determination in this investigation. Any C.V. of Mexico; Comercial Trevin˜ o de written submissions on other issues Notice of Receipt of Complaint; Reynosa, S.A. de C.V. of Mexico; H & F must also be filed by no later than the Solicitation of Comments Relating to Tech International S.A. de C.V. of close of business, eight calendar days the Public Interest Mexico; MPC Foods S.A. de C.V. of after publication of this notice in the Mexico; Myrna Guadalupe Perez Federal Register. Complainant may file AGENCY: U.S. International Trade Martinez of Mexico; Leticia Ange´lica replies to any written submissions no Commission. Saenz Fernandez of Mexico; Yoselen later than three calendar days after the ACTION: Notice. Susana Martinez Tirado of Mexico; date on which any initial submissions Distribuidora Mercatto S.A. de C.V. of were due. No other submissions will be SUMMARY: Notice is hereby given that Mexico; Comercializadora Embers S.A. accepted, unless requested by the the U.S. International Trade de C.V. of Mexico; and Manuel Bautista Commission. Any submissions and Commission has received a complaint Nogales of Mexico. The complainant replies filed in response to this Notice entitled Certain Electrolyte Containing requests that the Commission issue a are limited to five (5) pages in length, Beverages and Labeling and Packaging general exclusion order, cease and inclusive of attachments. Thereof, DN 3547; the Commission is desist orders, and impose a bond upon Persons filing written submissions soliciting comments on any public respondent alleged infringing articles must file the original document interest issues raised by the complaint during the 60-day Presidential review electronically on or before the deadlines or complainant’s filing pursuant to the period pursuant to 19 U.S.C. 1337(j). stated above. Submissions should refer

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to the docket number (‘‘Docket No. Issued: May 7, 2021. conducting full reviews.1 Accordingly, 3547’’) in a prominent place on the Lisa Barton, the Commission determined that it cover page and/or the first page. (See Secretary to the Commission. would conduct expedited reviews Handbook for Electronic Filing [FR Doc. 2021–10003 Filed 5–11–21; 8:45 am] pursuant to section 751(c)(3) of the Procedures, Electronic Filing BILLING CODE 7020–02–P Tariff Act of 1930 (19 U.S.C. 1675(c)(3)). Procedures 1). Please note the For further information concerning Secretary’s Office will accept only the conduct of these reviews and rules electronic filings during this time. INTERNATIONAL TRADE of general application, consult the Filings must be made through the COMMISSION Commission’s Rules of Practice and Commission’s Electronic Document Procedure, part 201, subparts A and B Information System (EDIS, https:// [Investigation Nos. 731–TA–753, 754, and (19 CFR part 201), and part 207, edis.usitc.gov.) No in-person paper- 756 (Fourth Review)] subparts A, D, E, and F (19 CFR part 207). based filings or paper copies of any Cut-to-Length Carbon Steel Plate From Please note the Secretary’s Office will electronic filings will be accepted until China, Russia, and Ukraine; accept only electronic filings at this further notice. Persons with questions Scheduling of Expedited Five-Year time. Filings must be made through the regarding filing should contact the Reviews Commission’s Electronic Document Secretary at [email protected]. Information System (EDIS, https:// Any person desiring to submit a AGENCY: United States International edis.usitc.gov). No in-person paper- document to the Commission in Trade Commission. based filings or paper copies of any confidence must request confidential ACTION: Notice. electronic filings will be accepted until treatment. All such requests should be further notice. directed to the Secretary to the SUMMARY: The Commission hereby gives Staff report.—A staff report Commission and must include a full notice of the scheduling of expedited containing information concerning the statement of the reasons why the reviews pursuant to the Tariff Act of subject matter of the reviews will be Commission should grant such 1930 (‘‘the Act’’) to determine whether placed in the nonpublic record on May treatment. See 19 CFR 201.6. Documents revocation of the antidumping duty 13, 2021, and made available to persons for which confidential treatment by the order on cut-to-length carbon steel plate on the Administrative Protective Order from China and the termination of the Commission is properly sought will be service list for these reviews. A public suspended investigations on cut-to- treated accordingly. All information, version will be issued thereafter, length carbon steel plate from Russia including confidential business pursuant to § 207.62(d)(4) of the and Ukraine would be likely to lead to Commission’s rules. information and documents for which continuation or recurrence of material Written submissions.—As provided in confidential treatment is properly injury within a reasonably foreseeable § 207.62(d) of the Commission’s rules, sought, submitted to the Commission for time. interested parties that are parties to the purposes of this Investigation may be DATES: February 5, 2021. reviews and that have provided disclosed to and used: (i) By the individually adequate responses to the Commission, its employees and Offices, FOR FURTHER INFORMATION CONTACT: notice of institution,2 and any party and contract personnel (a) for Celia Feldpausch (202–205–2387), other than an interested party to the developing or maintaining the records Office of Investigations, U.S. reviews may file written comments with of this or a related proceeding, or (b) in International Trade Commission, 500 E the Secretary on what determination the internal investigations, audits, reviews, Street SW, Washington, DC 20436. Commission should reach in the and evaluations relating to the Hearing-impaired persons can obtain reviews. Comments are due on or before programs, personnel, and operations of information on this matter by contacting May 20, 2021 and may not contain new the Commission including under 5 the Commission’s TDD terminal on 202– factual information. Any person that is U.S.C. Appendix 3; or (ii) by U.S. 205–1810. Persons with mobility neither a party to the five-year reviews government employees and contract impairments who will need special nor an interested party may submit a personnel 2, solely for cybersecurity assistance in gaining access to the brief written statement (which shall not Commission should contact the Office purposes. All nonconfidential written contain any new factual information) of the Secretary at 202–205–2000. submissions will be available for public pertinent to the reviews by May 20, General information concerning the 2021. However, should the Department inspection at the Office of the Secretary Commission may also be obtained by and on EDIS.3 of Commerce (‘‘Commerce’’) extend the accessing its internet server (https:// time limit for its completion of the final This action is taken under the www.usitc.gov). The public record for results of its reviews, the deadline for authority of section 337 of the Tariff Act these reviews may be viewed on the comments (which may not contain new of 1930, as amended (19 U.S.C. 1337), Commission’s electronic docket (EDIS) factual information) on Commerce’s and of §§ 201.10 and 210.8(c) of the at https://edis.usitc.gov. final results is three business days after Commission’s Rules of Practice and SUPPLEMENTARY INFORMATION: the issuance of Commerce’s results. If Procedure (19 CFR 201.10, 210.8(c)). Background.—On February 5, 2021, comments contain business proprietary By order of the Commission. the Commission determined that the domestic interested party group 1 A record of the Commissioners’ votes is response to its notice of institution (85 available from the Office of the Secretary and at the 1 Commission’s website. Handbook for Electronic Filing Procedures: FR 69362, November 2, 2020) of the _ _ 2 The Commission has found a joint response to https://www.usitc.gov/documents/handbook on subject five-year reviews was adequate filing_procedures.pdf. its notice of institution filed on behalf of and that the respondent interested party ArcelorMittal USA LLC, Nucor Corporation, and 2 All contract personnel will sign appropriate group response was inadequate. The SSAB Enterprises, LLC, domestic producers of cut- nondisclosure agreements. to-length carbon steel plate, to each be individually 3 Electronic Document Information System Commission did not find any other adequate. Comments from other interested parties (EDIS): https://edis.usitc.gov. circumstances that would warrant will not be accepted (see 19 CFR 207.62(d)(2)).

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information (BPI), they must conform FOR FURTHER INFORMATION CONTACT: On December 16, 2020, the with the requirements of sections 201.6, Houda Morad, Office of the General Commission found a violation of section 207.3, and 207.7 of the Commission’s Counsel, U.S. International Trade 337 based on the misappropriation of rules. The Commission’s Handbook on Commission, 500 E Street SW, Complainants’ trade secrets (including Filing Procedures, available on the Washington, DC 20436, telephone (202) the Medytox manufacturing processes Commission’s website at https:// 708–4716. Copies of non-confidential but not the Medytox bacterial strain). www.usitc.gov/documents/handbook_ documents filed in connection with this See 85 FR 83610–11 (Dec. 22, 2020). on_filing_procedures.pdf, elaborates investigation may be viewed on the The Commission issued a limited upon the Commission’s procedures with Commission’s electronic docket (EDIS) exclusion order against certain respect to filings. at https://edis.usitc.gov. For help botulinum neurotoxin products that are In accordance with sections 201.16(c) accessing EDIS, please email imported and/or sold by Respondents and 207.3 of the rules, each document [email protected]. General Daewoong and Evolus and a CDO filed by a party to the reviews must be information concerning the Commission against Evolus. See id. The Commission served on all other parties to the reviews may also be obtained by accessing its also set a bond during the period of (as identified by either the public or BPI internet server at https://www.usitc.gov. Presidential review in an amount of service list), and a certificate of service The public record for this investigation $441 per 100U vial of Respondents’ must be timely filed. The Secretary will may be viewed on the Commission’s accused products. See id. not accept a document for filing without electronic docket (EDIS) at https:// On February 12, 2021, Complainants a certificate of service. edis.usitc.gov. Hearing-impaired filed an appeal from the Commission’s Determination.—The Commission has persons are advised that information on final determination with the Federal determined these reviews are this matter can be obtained by Circuit. On the same day, Respondents extraordinarily complicated and contacting the Commission’s TDD also filed an appeal from the therefore has determined to exercise its terminal on (202) 205–1810. Commission’s final determination of a violation of section 337. On February authority to extend the review period by SUPPLEMENTARY INFORMATION: On March 18, 2021, Complainants and Evolus up to 90 days pursuant to 19 U.S.C. 6, 2019, the Commission instituted this (‘‘Settling Parties’’) announced that they 1675(c)(5)(B). investigation under section 337 of the reached a settlement agreement to Tariff Act of 1930, as amended, 19 Authority: These reviews are being resolve all pending issues between conducted under authority of title VII of the U.S.C. 1337 (‘‘section 337’’), based on a them. Tariff Act of 1930; this notice is published complaint filed by Medytox Inc. On March 3, 2021, the Settling Parties pursuant to section 207.62 of the (‘‘Medytox’’) of Seoul, South Korea; Commission’s rules. filed a joint petition to rescind the LEO Allergan plc of Dublin, Ireland; and and CDO based on the settlement By order of the Commission. Allergan, Inc. of Irvine, California agreements between Complainants and Issued: May 7, 2021. (collectively, ‘‘Complainants’’). See 84 Evolus. No party opposed the joint Lisa Barton, FR 8112–13 (Mar. 6, 2019). The petition. On May 3, 2021, the Secretary to the Commission. complaint, as supplemented, alleges a Commission rescinded the remedial violation of section 337 based upon the [FR Doc. 2021–10004 Filed 5–11–21; 8:45 am] orders issued in this investigation based importation into the United States, the BILLING CODE 7020–02–P on the settlement agreements. Comm’n sale for importation, and the sale within Notice (May 3, 2021). the United States after importation of On February 25, 2021, Evolus filed an INTERNATIONAL TRADE certain botulinum toxin products, unopposed motion, pursuant to COMMISSION processes for manufacturing or relating Commission Rule 210.50(d) (19 CFR to same and certain products containing 210.50(d)), for the return of the bond it [Investigation No. 337–TA–1145 (Bond same by reason of misappropriation of Return)] paid under the CDO during the period trade secrets, the threat or effect of of Presidential review. On February 26, Certain Botulinum Toxin Products, which is to destroy or substantially 2021, the motion was amended to reflect Processes for Manufacturing or injure a domestic industry in the United Daewoong’s consent to the motion. On Relating to Same and Certain Products States. See id. The notice of March 4, 2021, OUII filed a response in Containing Same; Notice of investigation names as respondents support of the motion. Commission Decision Not To Review Daewoong Pharmaceuticals Co., Ltd. On March 31, 2021, the ALJ issued an Initial Determination Granting an (‘‘Daewoong’’) of Seoul, Republic of the subject ID granting the motion. The Unopposed Motion for Return of Bond; Korea and Evolus of Irvine, California ID notes that the motion was filed Return of Bond (collectively, ‘‘Respondents’’). See id. within 90 days of the expiration of the The Office of Unfair Import period of Presidential review, in AGENCY: U.S. International Trade Investigations (‘‘OUII’’) was also a party compliance with Commission Rule Commission. to the investigation. See id. 210.50(d)(1)(ii) (19 CFR 210.50(d)(1)(ii)). ACTION: Notice. On July 6, 2020, the ALJ issued a final See ID at 2. The ID also finds no initial determination (‘‘FID’’) finding a substantive or procedural reason to SUMMARY: Notice is hereby given that violation of section 337 based on the deny the return of the bond to Evolus. the U.S. International Trade misappropriation of Complainants’ See id. No petition for review of the Commission has determined not to asserted trade secrets (including the subject ID was filed. review an initial determination (‘‘ID’’) of Medytox bacterial strain and Medytox The Commission has determined not the presiding Administrative Law Judge manufacturing processes), the threat or to review the subject ID. The bond is (‘‘ALJ’’) granting an unopposed motion effect of which is to destroy or returned to Evolus. of respondent Evolus, Inc. (‘‘Evolus’’) substantially injure an industry in the The Commission’s vote on this for the return of the bond it paid under United States. On September 21, 2020, determination took place on May 6, the cease and desist order (‘‘CDO’’) the Commission issued a notice 2021. during the period of Presidential review. determining to review the FID in part. The authority for the Commission’s The bond is returned to Evolus. See 85 FR 60489–90 (Sept. 25, 2020). determination is contained in section

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337 of the Tariff Act of 1930, as importation into the United States, the Having examined the record of this amended (19 U.S.C. 1337), and in part sale for importation, or the sale within investigation, including the FID, the 210 of the Commission’s Rules of the United States after importation of petitions for review, and the responses Practice and Procedure (19 CFR part certain collapsible and portable thereto, the Commission has determined 210). furniture by reason of infringement of to review the FID with respect to (1) all By order of the Commission. certain claims of U.S. Patent No. of the FID’s findings concerning the ’824 Issued: May 6, 2021. 9,282,824 (‘‘the ’824 patent’’) and U.S. patent; (2) infringement and validity of Patent No. 9,060,611 (‘‘the ’611 patent’’). Lisa Barton, the ’611 patent; and (3) the FID’s Id. at 52896–97. The complaint further findings concerning the economic prong Secretary to the Commission. alleges that a domestic industry exists. of the domestic industry requirement. [FR Doc. 2021–09990 Filed 5–11–21; 8:45 am] Id. at 52897. The Commission’s notice The Commission has determined not to BILLING CODE 7020–02–P of investigation named the following review the remainder of the FID. respondents: Denovo Brands, LLC of On review, the Commission has Bentonville, Akansas; Zhenli determined to affirm the FID’s finding of INTERNATIONAL TRADE (Zhangzhou) Industrial Co., Ltd. of no violation of section 337 with regard COMMISSION Zhangzhou, Fujian, China; Fujian to the ’824 patent and the ’611 patent. [Investigation No. 337–TA–1178] Zenithen Consumer Products Co., Ltd. In connection with that determination of Fuzhou, Fujian, China; Zenithen the Commission has also determined to Certain Collapsible and Portable Hong Kong Ltd. of Hong Kong; Zenithen modify and supplement certain of the Furniture; Notice of a Commission USA LLC of Upland, California; FID’s subsidiary findings. The Determination To Review in Part a Westfield Outdoor, Inc., d/b/a Westfield Commission has also determined to take Final Initial Determination and To Outdoors of Indianapolis, Indiana; no position on certain portions of the Affirm With Modifications the Finding MacSports Inc. of La Verne, California; FID. The Commission opinion is issued of No Violation of Section 337; Meike (Qingdao) Leisure Products Co., concurrently herewith. Termination of the Investigation Ltd of Qing Dao, China. Id. The Office The investigation is hereby of Unfair Import Investigations is not AGENCY: U.S. International Trade terminated. participating in the investigation. Id. Commission. The Commission vote for this During the course of the investigation, determination took place on May 6, ACTION: Notice. respondents Fujian Zenithen Consumer 2021. SUMMARY: Notice is hereby given that Products Co., Ltd., Zenithen Hong Kong The authority for the Commission’s the U.S. International Trade Ltd., and Zenithen USA LLC were determination is contained in section Commission (‘‘Commission’’) has terminated from the investigation. The 337 of the Tariff Act of 1930, as determined to review in part the remaining respondents are Denovo amended (19 U.S.C. 1337), and in Part Administrative Law Judge’s (‘‘ALJ’’) Brands, LLC and Zhenli (Zhangzhou) 210 of the Commission’s Rules of final initial determination (‘‘FID’’), Industrial Co., Ltd. (the ‘‘Denovo’’ Practice and Procedure (19 CFR part issued on February 18, 2021, and to respondents); Westfield Outdoor, Inc. 210). (‘‘Westfield’’); and MacSports Inc. and affirm with modifications the FID’s By order of the Commission. finding of no violation of section 337 in Meike (Qingdao) Leisure Products Co., Ltd (the ‘‘MacSports’’ respondents) Issued: May 6, 2021. the above-referenced investigation. The Lisa Barton, investigation is terminated. (collectively, ‘‘Respondents’’). On February 18, 2021, the ALJ issued Secretary to the Commission. FOR FURTHER INFORMATION CONTACT: his FID in this investigation. The FID [FR Doc. 2021–09989 Filed 5–11–21; 8:45 am] Benjamin S. Richards, Esq., Office of the found no violation of section 337. For BILLING CODE 7020–02–P General Counsel, U.S. International the ’824 patent, the FID found that GCI Trade Commission, 500 E Street SW, established infringement by Denovo’s Washington, DC 20436, telephone (202) products but failed to establish that GCI DEPARTMENT OF JUSTICE 708–5453. Copies of non-confidential satisfied the technical prong of the documents filed in connection with this domestic industry requirement. The FID Bureau of Alcohol, Tobacco, Firearms investigation may be viewed on the also found that Denovo did not establish and Explosives Commission’s electronic docket (EDIS) that any of the asserted claims of the at https://edis.usitc.gov. For help ’824 patent is invalid. For the ’611 [OMB Number 1140–0072] accessing EDIS, please email patent, the FID found that GCI failed to [email protected]. General Agency Information Collection establish infringement by Westfield’s Activities; Proposed eCollection of information concerning the Commission and MacSports’ products but did may also be obtained by accessing its eComments Requested; Revision of a establish that GCI satisfied the technical Currently Approved Collection; internet server at https://www.usitc.gov. prong of the domestic industry Hearing-impaired persons are advised Explosives Employee Possessor requirement. The FID also found that Questionnaire—ATF Form 5400.28 that information on this matter can be Westfield and MacSports did not obtained by contacting the establish that any of the asserted claims AGENCY: Bureau of Alcohol, Tobacco, Commission’s TDD terminal on (202) of the ’611 patent is invalid. The FID Firearms and Explosives, Department of 205–1810. additionally found that GCI established Justice. SUPPLEMENTARY INFORMATION: The that it satisfied the economic prong of ACTION: 60-Day notice. Commission instituted this investigation the domestic industry requirement for on October 3, 2019. 84 FR 52896 (Oct. both asserted patents. SUMMARY: The Bureau of Alcohol, 3, 2019). The complaint, as amended, On March 2, 2021 the parties Tobacco, Firearms and Explosives filed by GCI Outdoor, Inc., of Higganum, submitted petitions seeking review of (ATF), Department of Justice (DOJ), will Connecticut (‘‘GCI’’), alleges violations the FID. On March 10, 2021, the parties submit the following information of section 337 of the Tariff Act of 1930, submitted responses to the others’ collection request to the Office of as amended, 19 U.S.C. 1337, in the petitions. Management and Budget (OMB) for

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review and approval in accordance with of information technology, e.g., Square, 145 N Street NE, 3E.405A, the Paperwork Reduction Act of 1995. permitting electronic submission of Washington, DC 20530. The proposed collection OMB 1140– responses. Dated: May 7, 2021. 0072 (Explosives Employee Possessor Overview of This Information Melody Braswell, Questionnaire—ATF Form 5400.28) is Collection Department Clearance Officer for PRA, U.S. being revised to include additional Department of Justice. questions, and a new format and layout 1. Type of Information Collection to improve user experience. This (check justification or form 83): [FR Doc. 2021–10005 Filed 5–11–21; 8:45 am] collection is also being published to Revision of a currently approved BILLING CODE 4410–FY–P obtain comments from the public and collection. affected agencies. 2. The Title of the Form/Collection: DEPARTMENT OF JUSTICE DATES: Comments are encouraged and Explosives Employee Possessor will be accepted for 60 days until July Questionnaire. Drug Enforcement Administration 12, 2021. 3. The agency form number, if any, and the applicable component of the FOR FURTHER INFORMATION CONTACT: If [Docket No. DEA–826] you have additional comments, Department sponsoring the collection: regarding the estimated public burden Form number (if applicable): ATF Bulk Manufacturer of Controlled or associated response time, Form 5400.28. Substances Application: Patheon API suggestions, or need a copy of the Component: Bureau of Alcohol, Manufacturing, Inc. proposed information collection Tobacco, Firearms and Explosives, U.S. instrument with instructions, or Department of Justice. AGENCY: Drug Enforcement additional information, please contact: 4. Affected public who will be asked Administration, Justice. Shawn Stevens, Federal Explosives or required to respond, as well as a brief ACTION: Notice of application. Licensing Center either by mail at 44 abstract: Needy Road, Martinsburg, WV 25405, Primary: Individuals or households. SUMMARY: Patheon API Manufacturing, by email at [email protected], or Other (if applicable): Business or Inc., has applied to be registered as a by telephone at 304–616–4400. other for-profit. bulk manufacturer of basic class(es) of SUPPLEMENTARY INFORMATION: Written Abstract: The Explosives Employee controlled substance(s). Refer to comments and suggestions from the Possessor Questionnaire—ATF Form SUPPLEMENTARY INFORMATION listed public and affected agencies concerning 5400.28 will be used to determine if an below for further drug information. the proposed collection of information individual is qualified to serve as an DATES: Registered bulk manufacturers of are encouraged. Your comments should employee possessor, who can ship, the affected basic class(es), and address one or more of the following transport, receive, and/or possess applicants therefore, may file written four points: materials for an explosives business or comments on or objections to the —Evaluate whether the proposed operation. issuance of the proposed registration on collection of information is necessary 5. An estimate of the total number of or before July 12, 2021. Such persons for the proper performance of the respondents and the amount of time may also file a written request for a functions of the agency, including estimated for an average respondent to hearing on the application on or before whether the information will have respond: An estimated 10,000 July 12, 2021. respondents will use the form annually, practical utility; ADDRESSES: and it will take each respondent Written comments should —Evaluate the accuracy of the agency’s be sent to: Drug Enforcement estimate of the burden of the approximately 20 minutes to complete their responses. Administration, Attention: DEA Federal proposed collection of information, Register Representative/DPW, 8701 including the validity of the 6. An estimate of the total public burden (in hours) associated with the Morrissette Drive, Springfield, Virginia methodology and assumptions used; 22152. —Evaluate whether and if so, how the collection: The estimated annual public quality, utility, and clarity of the burden associated with this collection is SUPPLEMENTARY INFORMATION: In information to be collected can be 3,334 hours, which is equal to 10,000 (# accordance with 21 CFR 1301.33(a), this enhanced; and of respondents) * .3333 (20 minutes). is notice that on March 18, 2021, —Minimize the burden of the collection If additional information is required Patheon API Manufacturing, Inc., 309 of information on those who are to contact: Melody Braswell, Department Delaware Street, Greenville, South respond, including through the use of Clearance Officer, United States Carolina 29605–5420, applied to be appropriate automated, electronic, Department of Justice, Justice registered as a bulk manufacturer of the mechanical, or other technological Management Division, Policy and following basic class(es) of controlled collection techniques or other forms Planning Staff, Two Constitution substance(s):

Controlled substance Drug code Schedule

Gamma Hydroxybutyric Acid ...... 2010 I Tetrahydrocannabinols ...... 7370 I 5-Methoxy-N-N-Dimethyltryptamine ...... 7431 I a-Methyltryptamine ...... 7432 I Psilocybin ...... 7437 I Thebaine ...... 9333 II Oxymorphone ...... 9652 II Noroxymorphone ...... 9668 II

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The company plans to bulk Revenue Service’s (IRS) Statistics of Agenda manufacture the listed controlled Income (SOI) Annual Individual Income Day 1: June 10, 2021 substances as an Active Pharmaceutical Tax ZIP Code Data, and the U.S. Ingredient (API) for distribution to its Securities and Exchange Commission’s • Welcome, Introductions, Opening customers. In reference to dug code (SEC) Electronic Data Gathering, Remarks 7370 (Tetrahydrocannabinols), the Analysis, and Retrieval (EDGAR) • Report of the CEOSE Executive company plans to bulk manufacture this System. Liaison • drug as synthetic. No other activities for Presentation: Missing Millions and these drug codes are authorized for this FOR FURTHER INFORMATION CONTACT: NSF Efforts • registration. Regina Kearney at the OMB Office of Joint Session with NSB [Focus on Federal Financial Management at (202) STEM Technical Careers] William T. McDermott, 395–3993. • Discussion with NSF Director and Assistant Administrator. Chief Operating Officer Shalanda Young, [FR Doc. 2021–09988 Filed 5–11–21; 8:45 am] • CEOSE Liaison Reports Acting Director. BILLING CODE P • Working Session: DCL and Flyer for [FR Doc. 2021–10025 Filed 5–11–21; 8:45 am] the 2019–2020 CEOSE Report BILLING CODE 3110–01–P Day 2: June 11, 2021 OFFICE OF MANAGEMENT AND • BUDGET Welcome and Remarks about Subcommittee: The Future of EPSCoR Designation of Databases for NATIONAL SCIENCE FOUNDATION • BP Accountability Data Treasury’s Working System Under the • Presentation: Broadening Committee on Equal Opportunities in Do Not Pay Initiative Participation Research Science and Engineering; Notice of • Reports of the Federal Liaisons AGENCY: Office of Management and Meeting • Presentation: NSF’s Racial Equity Budget. Task Force ACTION: Notice of designation. In accordance with the Federal • Reports of the CEOSE Liaisons Advisory Committee Act (Pub. L. 92– • Announcements, Closing Remarks, SUMMARY: The Payment Integrity 463, as amended), the National Science and Adjournment Information Act of 2019 (PIIA) Foundation (NSF) announces the Dated: May 7, 2021. authorizes the Office of Management following meeting: Crystal Robinson, and Budget (OMB) to designate Name and Committee Code: Committee Management Officer. databases for inclusion in Treasury’s Committee on Equal Opportunities in Working System under the Do Not Pay Science and Engineering (CEOSE) [FR Doc. 2021–10033 Filed 5–11–21; 8:45 am] (DNP) Initiative. PIIA further requires Virtual Meeting (1173). BILLING CODE 7555–01–P OMB to provide public notice and Date and Time: June 10, 2021; 1:00 opportunity for comment prior to p.m.–5:30 p.m.; June 11, 2021; 10:00 designating additional databases. In NUCLEAR REGULATORY a.m.–3:30 p.m. fulfillment of this requirement, on COMMISSION Place: National Science Foundation, January 22, 2021, OMB published a [NRC–2021–0001] Notice of Proposed Designation for 12 2415 Eisenhower Avenue, Alexandria, additional databases. OMB received one VA 22314 (Virtual). Meeting Sunshine Act Meetings comment during the 30-day comment Registration: Virtual attendance period for this notice; however, the information will be forthcoming on the TIME AND DATE: Weeks of May 17, 24, 31, suggestions found therein did not CEOSE website at http://www.nsf.gov/ June 7, 14, 21, 2021. preclude further action for the formal od/oia/activities/ceose/index.jsp. PLACE: Commissioners’ Conference designation of the databases into Type of Meeting: Open. Room, 11555 Rockville Pike, Rockville, Treasury’s Working System. Effective Contact Person: Dr. Bernice Maryland. immediately, OMB designates the Anderson, Senior Advisor and CEOSE STATUS: Public. following 12 databases: The United Executive Secretary, Office of MATTERS TO BE CONSIDERED: States Postal Service (USPS) Delivery Integrative Activities (OIA), National Sequence File, the Census Bureau Science Foundation, 2415 Eisenhower Week of May 17, 2021 Federal Audit Clearinghouse, the Do Avenue, Alexandria, VA 22314. Contact Monday, May 17, 2021 Not Pay (DNP) Agency Adjudication Information: 703–292–8040/banderso@ 3:00 p.m.—Affirmation Session (Public Data, Fiscal Service’s Payments, Claims, nsf.gov. and Enhanced Reconciliation (PACER) Meeting) (Tentative), Direct Final database, Bureau of Prisons (BOP) Minutes: Meeting minutes and other Rule: Advanced Boiling Water Incarceration Data, Digital information may be obtained from the Reactor Design Certification Accountability and Transparency Act CEOSE Executive Secretary at the above Renewal (RIN 3150–AK04; NRC– (DATA Act) data, Census Bureau’s address or the website at http:// 2017–0090) (Tentative) (Contact: American Communities Survey (ACS) www.nsf.gov/od/oia/activities/ceose/ Wesley Held: 301–287–3591) Annual State and County Data Profiles, index.jsp. Additional Information: Due to Veterans Affairs’ (VA) Beneficiary Purpose of Meeting: To study data, COVID–19, there will be no physical Identification Records Locator Service programs, policies, and other public attendance. The public is invited (BIRLS), Department of Agriculture’s information pertinent to the National to attend the Commission’s meeting National Disqualified List (NDL), Center Science Foundation and to provide live; via teleconference. Details for for Medicare and Medicaid Services advice and recommendations joining the teleconference in listen only (CMS) National Plan and Provider concerning broadening participation in mode may be found at https:// Enumeration System (NPPES), Internal science and engineering. www.nrc.gov/pmns/mtg.

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Week of May 24, 2021—Tentative Commission meetings is subject to FOR FURTHER INFORMATION CONTACT: change on short notice. David A. Trissell, General Counsel, at Tuesday, May 25, 2021 The NRC Commission Meeting 202–789–6820. 9:00 a.m.—Strategic Programmatic Schedule can be found on the internet SUPPLEMENTARY INFORMATION: Overview of the Fuel Facilities and at: https://www.nrc.gov/public-involve/ the Spent Fuel Storage and public-meetings/schedule.html. Table of Contents Transportation Business Lines The NRC provides reasonable I. Introduction (Public Meeting) (Contact: Damaris accommodation to individuals with II. Docketed Proceeding(s) Marcano: 301–415–7328) disabilities where appropriate. If you I. Introduction Additional Information: Due to need a reasonable accommodation to COVID–19, there will be no physical participate in these public meetings or The Commission gives notice that the public attendance. The public is invited need this meeting notice or the Postal Service filed request(s) for the to attend the Commission’s meeting live transcript or other information from the Commission to consider matters related by webcast at the Web address—https:// public meetings in another format (e.g., to negotiated service agreement(s). The request(s) may propose the addition or video.nrc.gov/. braille, large print), please notify Anne Silk, NRC Disability Program Specialist, removal of a negotiated service Week of May 31, 2021—Tentative at 301–287–0745, by videophone at agreement from the market dominant or There are no meetings scheduled for 240–428–3217, or by email at the competitive product list, or the the week of May 31, 2021. [email protected]. Determinations on modification of an existing product requests for reasonable accommodation currently appearing on the market Week of June 7, 2021—Tentative will be made on a case-by-case basis. dominant or the competitive product Tuesday, June 8, 2021 Members of the public may request to list. Section II identifies the docket receive this information electronically. 10:00 a.m.—Briefing on Human Capital number(s) associated with each Postal If you would like to be added to the and Equal Employment Service request, the title of each Postal distribution, please contact the Nuclear Opportunity (Public Meeting) Service request, the request’s acceptance (Contact: Anne DeFrancisco: 610– Regulatory Commission, Office of the date, and the authority cited by the 337–5078) Secretary, Washington, DC 20555, at Postal Service for each request. For each 301–415–1969, or by email at Additional Information: Due to request, the Commission appoints an [email protected] or Tyesha.Bush@ COVID–19, there will be no physical officer of the Commission to represent nrc.gov. public attendance. The public is invited the interests of the general public in the The NRC is holding the meetings to attend the Commission’s meeting live proceeding, pursuant to 39 U.S.C. 505 under the authority of the Government by webcast at the Web address—https:// (Public Representative). Section II also in the Sunshine Act, 5 U.S.C. 552b. video.nrc.gov/. establishes comment deadline(s) Dated: May 10, 2021. pertaining to each request. Thursday, June 10, 2021 For the Nuclear Regulatory Commission. The public portions of the Postal 10:00 a.m.—Briefing on Results of the Wesley W. Held, Service’s request(s) can be accessed via Agency Action Review Meeting Policy Coordinator, Office of the Secretary. the Commission’s website (http:// www.prc.gov). Non-public portions of (Public Meeting) (Contact: Nicole [FR Doc. 2021–10136 Filed 5–10–21; 4:15 pm] the Postal Service’s request(s), if any, Fields: 630–829–9570) BILLING CODE 7590–01–P Additional Information: Due to can be accessed through compliance COVID–19, there will be no physical with the requirements of 39 CFR 1 public attendance. The public is invited 3011.301. POSTAL REGULATORY COMMISSION The Commission invites comments on to attend the Commission’s meeting live whether the Postal Service’s request(s) by webcast at the Web address—https:// [Docket Nos. MC2021–88 and CP2021–91] in the captioned docket(s) are consistent video.nrc.gov/. New Postal Products with the policies of title 39. For Week of June 14, 2021—Tentative request(s) that the Postal Service states AGENCY: Postal Regulatory Commission. There are no meetings scheduled for concern market dominant product(s), ACTION: Notice. the week of June 14, 2021. applicable statutory and regulatory requirements include 39 U.S.C. 3622, 39 SUMMARY: Week of June 21, 2021—Tentative The Commission is noticing a U.S.C. 3642, 39 CFR part 3030, and 39 recent Postal Service filing for the Tuesday, June 22, 2021 CFR part 3040, subpart B. For request(s) Commission’s consideration concerning that the Postal Service states concern 9:00 a.m.—Briefing on Transformation a negotiated service agreement. This competitive product(s), applicable at the NRC—Midyear Review notice informs the public of the filing, statutory and regulatory requirements (Public Meeting) (Contact: Maria invites public comment, and takes other include 39 U.S.C. 3632, 39 U.S.C. 3633, Arribas-Colon: 301–415–6026) administrative steps. 39 U.S.C. 3642, 39 CFR part 3035, and Additional Information: Due to DATES: Comments are due: May 14, 39 CFR part 3040, subpart B. Comment COVID–19, there will be no physical 2021. deadline(s) for each request appear in public attendance. The public is invited ADDRESSES: Submit comments section II. to attend the Commission’s meeting live electronically via the Commission’s II. Docketed Proceeding(s) by webcast at the Web address—https:// Filing Online system at http:// video.nrc.gov/. www.prc.gov. Those who cannot submit 1. Docket No(s).: MC2021–88 and CONTACT PERSON FOR MORE INFORMATION: comments electronically should contact CP2021–91; Filing Title: USPS Request For more information or to verify the the person identified in the FOR FURTHER 1 INFORMATION CONTACT See Docket No. RM2018–3, Order Adopting status of meetings, contact Wesley Held section by Final Rules Relating to Non-Public Information, at 301–287–3591 or via email at telephone for advice on filing June 27, 2018, Attachment A at 19–22 (Order No. [email protected]. The schedule for alternatives. 4679).

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to Add Priority Mail Contract 698 to and basis for, the proposed rule change Settlement Price (the ‘‘Index’’), less the Competitive Product List and Notice of and discussed any comments it received Trust’s liabilities and expenses. The Filing Materials Under Seal; Filing on the proposed rule change. The text purpose of the Trust is to provide Acceptance Date: May 6, 2021; Filing of those statements may be examined at investors with a cost-effective and Authority: 39 U.S.C. 3642, 39 CFR the places specified in Item IV below. convenient way to invest in bitcoin in 3040.130 through 3040.135, and 39 CFR The Exchange has prepared summaries, a manner that is more efficient and 3035.105; Public Representative: set forth in sections A, B, and C below, convenient than the purchase of a stand- Kenneth R. Moeller; Comments Due: of the most significant parts of such alone bitcoin, while also mitigating May 14, 2021. statements. some of the risk by reducing the This Notice will be published in the volatility typically associated with the A. Self-Regulatory Organization’s Federal Register. purchase of stand-alone bitcoin and Statement of the Purpose of, and the without the uncertain and often Erica A. Barker, Statutory Basis for, the Proposed Rule complex requirements relating to Secretary. Change acquiring and/or holding bitcoin. [FR Doc. 2021–10001 Filed 5–11–21; 8:45 am] 1. Purpose According to the Registration BILLING CODE 7710–FW–P Statement, the Trust will only hold The Exchange proposes to list and bitcoin, and will, from time to time, trade shares (‘‘Shares’’) of the Valkyrie issue Baskets 5 in exchange for deposits Bitcoin Fund (the ‘‘Trust’’) under NYSE of bitcoins and to distribute bitcoins in SECURITIES AND EXCHANGE Arca Rule 8.201–E, which governs the connection with redemptions of COMMISSION listing and trading of Commodity-Based Baskets. The Shares of the Trust Trust Shares. [Release No. 34–91771; File No. SR– represent units of fractional undivided NYSEArca–2021–31] Description of the Trust beneficial interest in, and ownership of, Self-Regulatory Organizations; NYSE The Shares will be issued by the the Trust. The bitcoins held by the Arca, Inc.; Notice of Filing of a Trust, a Delaware statutory trust. The Custodian on behalf of the Trust will be Proposed Rule Change To List and Trust will operate pursuant to a trust transferred out of the Bitcoin Account Trade Shares of the Valkyrie Bitcoin agreement (the ‘‘Trust Agreement’’) only in the following circumstances: Fund Under NYSE Arca Rule 8.201–E between Valkyrie Digital Assets LLC Transferred to pay the Sponsor’s Fee, (the ‘‘Sponsor’’) and Delaware Trust distributed to Authorized Participants May 6, 2021. Company, as the Trust’s trustee (the or Liquidity Providers, as applicable, in 1 Pursuant to Section 19(b)(1) of the ‘‘Trustee’’). The Shares will be connection with the redemption of Securities Exchange Act of 1934 (the registered with the Commission by Baskets, transferred to be sold on an as- 2 3 ‘‘Act’’) and Rule 19b–4 thereunder, means of the Trust’s registrations needed basis to pay Additional Trust notice is hereby given that, on April 23, statement on Form S–1 (the Expenses, sold on behalf of the Trust in 2021, NYSE Arca, Inc. (‘‘NYSE Arca’’ or ‘‘Registration Statement’’).4 Pursuant to the event the Trust terminates and the ‘‘Exchange’’) filed with the the Trust Agreement, the Sponsor has liquidates its assets or as otherwise Securities and Exchange Commission entered into a custodian agreement (the required by law or regulation. (the ‘‘Commission’’) the proposed rule ‘‘Custodian Agreement’’) with Coinbase Custody of the Trust’s Bitcoins change as described in Items I, II, and Custody Trust Company, LLC (the According to the Registration III below, which Items have been ‘‘Custodian’’) to act as custodian for the Statement, the Custodian is a New York- prepared by the self-regulatory Trust’s bitcoins. Pursuant to the state chartered trust company operating organization. The Commission is Custodian Agreement, the Custodian under the direct supervision of the New publishing this notice to solicit will establish accounts that hold the York State Department of Financial comments on the proposed rule change bitcoins deposited with the Custodian Services and is subject to the anti- from interested persons. on behalf of the Trust. U.S. Bancorp money laundering requirements of the Fund Services, LLC will act as the I. Self-Regulatory Organization’s Financial Crimes Enforcement Network transfer agent for the Trust (the Statement of the Terms of Substance of (‘‘FinCEN’’). In addition, the Custodian ‘‘Transfer Agent’’) and as the the Proposed Rule Change is a qualified custodian under the administrator of the Trust (the The Exchange proposes to list and Investment Advisers Act of 1940. Under ‘‘Administrator’’) to perform various trade the shares of the Valkyrie Bitcoin the Custodian Agreement, the Custodian administrative, accounting and Fund under NYSE Arca Rule 8.201–E. will be responsible for the safety and recordkeeping functions on behalf of the The proposed change is available on the security of the Trust’s Bitcoins as well Trust. Exchange’s website at www.nyse.com, at as overseeing the process of deposit, the principal office of the Exchange, and Description of the Trust withdrawal, sale and purchase of the at the Commission’s Public Reference According to the Registration Trust’s bitcoins. The Custodian will Room. Statement, the investment objective of custody the bitcoin in accordance with the Trust is for the Shares to reflect the the terms of the Custodian Agreement. II. Self-Regulatory Organization’s According to the Registration Statement of the Purpose of, and performance of the value of a bitcoin as represented by the CF Bitcoin US Statement, all bitcoins exist and are Statutory Basis for, the Proposed Rule stored on the Blockchain, the Change 4 See Registration Statement on Form S–1, dated decentralized transaction ledger of the In its filing with the Commission, the January 22, 2021 filed with the Commission by the Bitcoin Network. The Blockchain self-regulatory organization included Sponsor on behalf of the Trust (File No. 333– records most transactions (including statements concerning the purpose of, 252344). The descriptions of the Trust contained mining of new bitcoins) for all bitcoins herein are based, in part, on information in the Registration Statement. The Registration Statement in existence, and in doing so verifies the 1 15 U.S.C. 78s(b)(1). in not yet effective and the Shares will not trade 2 15 U.S.C. 78a. on the Exchange until such time that the 5 According to the Registration Statement, a 3 17 CFR 240.19b–4. Registration Statement is effective. Basket equals a block of 50,000 Shares.

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location of each bitcoin (or fraction a possible delay in operations of 72 ‘‘Satoshi Nakamoto.’’ The protocol thereof) in a particular digital wallet. hours, while one or more of the ‘‘backup underlying Bitcoin was subsequently The Bitcoin Account will be maintained vaults’’ is transitioned to a signing vault. released in 2009 as open source by the Custodian and cold storage 6 These Security Procedures ensure that software and currently operates on a mechanisms will be used for the Vault there is no single point of failure in the worldwide network of computers. Account by the Custodian. Each digital protection of the Trust’s assets. The first step in directly using the wallet of the Trust may be accessed Bitcoin network for transactions is to Overview of the Bitcoin Industry and using its corresponding private key. The download specialized software referred Market 7 Custodian’s custodial operations will to as a ‘‘bitcoin wallet.’’ A user’s bitcoin maintain custody of the private keys Bitcoin wallet can run on a computer or that have been deposited in cold storage According to the Registration smartphone, and can be used both to at its various vaulting premises which Statement, bitcoin is the digital asset send and to receive bitcoin. Within a are located in geographically dispersed that is native to, and created and bitcoin wallet, a user can generate one locations across the world, including transmitted through the operations of, or more unique ‘‘bitcoin addresses,’’ but not limited to the United States, the peer-to-peer Bitcoin network, a which are conceptually similar to bank Europe, including Switzerland, and decentralized network of computers that account numbers. After establishing a South America. The locations of the operates on cryptographic protocols. No bitcoin address, a user can send or vaulting premises may change regularly single entity owns or operates the receive bitcoin from his or her bitcoin and are kept confidential by the Bitcoin network, the infrastructure of address to another user’s address. Custodian for security purposes. which is collectively maintained by a Sending bitcoin from one bitcoin According to the Registration decentralized user base. The Bitcoin address to another is similar in concept Statement, the Custodian is the network allows people to exchange to sending a bank wire from one custodian of the Trust’s private keys in tokens of value, called bitcoin, which person’s bank account to another accordance with the terms and are recorded on a public transaction person’s bank account; provided, provisions of the Custodian Agreement ledger known as the Blockchain. Bitcoin however, that such transactions are not and will utilize the certain security can be used to pay for goods and managed by an intermediary and procedures such as algorithms, codes, services, or it can be converted to fiat erroneous transactions generally may passwords, encryption or telephone currencies, such as the U.S. dollar, at not be reversed or remedied once sent. call-backs (together, the ‘‘Security rates determined on bitcoin trading The amount of bitcoin associated with Procedures’’) in the administration and platforms or in individual end-user-to- each bitcoin address, as well as each operation of the Trust and the end-user transactions under a barter bitcoin transaction to or from such safekeeping of its bitcoins and private system. address, is transparently reflected in the keys. The Custodian will create a Vault The value of bitcoin is determined by Blockchain and can be viewed by Account for the Trust assets in which the supply of and demand for bitcoin. websites that operate as ‘‘blockchain private keys are placed in cold storage. New bitcoins are created and rewarded explorers.’’ Copies of the Blockchain The Custodian will segregate the private to the parties providing the Bitcoin exist on thousands of computers on the keys stored with it from any other assets network’s infrastructure (‘‘miners’’) in Bitcoin network. A user’s bitcoin wallet it holds or holds for others. Further, exchange for their expending will either contain a copy of the multiple distinct private keys must sign computational power to verifying blockchain or be able to connect with any transaction in order to transfer the transactions and add them to the another computer that holds a copy of Trust’s bitcoins from a multi-signature Blockchain. The Blockchain is the blockchain. The innovative design address to any other address on the effectively a decentralized database that of the Bitcoin network protocol allows Bitcoin blockchain. Distinct private keys includes all blocks that have been each Bitcoin user to trust that their copy required for multi-signature address solved by miners and it is updated to of the Blockchain will generally be transfers reside in geographically include new blocks as they are solved. updated consistent with each other dispersed vault locations, known as Each bitcoin transaction is broadcast to user’s copy. ‘‘signing vaults.’’ In addition to multiple the Bitcoin network and, when included Bitcoin Protocol signing vaults, the Custodian maintains in a block, recorded in the Blockchain. According to the Registration multiple ‘‘back-up vaults’’ in which As each new block records outstanding backup private keys are stored. In the Statement, the Bitcoin protocol is open bitcoin transactions, and outstanding source software, meaning any developer event that one or more of the ‘‘signing transactions are settled and validated vaults’’ is compromised, the back-up can review the underlying code and through such recording, the Blockchain suggest changes. There is no official vaults would be activated and used as represents a complete, transparent and signing vaults to complete a transaction company or group that is responsible for unbroken history of all transactions of making modifications to Bitcoin. There within 72 hours. As such, if any one the Bitcoin network. signing vault is compromised, it would are, however, a number of individual have no impact on the ability of the Bitcoin Network developers that regularly contribute to a specific distribution of Bitcoin software Trust to access its bitcoins, other than According to the Registration known as the ‘‘Bitcoin Core,’’ which is Statement, bitcoin was first described in 6 maintained in an open-source repository According to the Registration Statement, the a white paper released in 2008 and term ‘‘cold storage’’ refers to a safeguarding method on the website Github. There are many published under the pseudonym by which the private keys corresponding to bitcoins other compatible versions of Bitcoin stored on a digital wallet are removed from any computers actively connected to the internet. Cold 7 For the purpose of this section, Bitcoin with an software, but Bitcoin Core provides the storage of private keys may involve keeping such upper case ‘‘B’’ is used to describe the system as de-facto standard for the Bitcoin wallet on a non-networked computer or electronic a whole that is involved in maintaining the ledger protocol, also known as the ‘‘reference device or storing the public key and private keys of bitcoin ownership and facilitating the transfer of software.’’ The core developers for relating to the digital wallet on a storage device (for bitcoin among parties. When referring to the digital example, a USB thumb drive) or printed medium asset within the bitcoin network, bitcoin is written Bitcoin Core operate under a volunteer (for example, papyrus or paper) and deleting the with a lower case ‘‘b’’ (except, at the beginning of basis and without strict hierarchical digital wallet from all computers. sentences or paragraph sections). administration.

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Significant changes to the Bitcoin amount of bitcoin to be sent, a automatically halved every 210,000 protocol are typically accomplished transaction fee and the sender’s digital blocks. Thus, the current fixed reward through a so-called ‘‘Bitcoin signature. Bitcoin transactions are for solving a new block is 6.25 bitcoin Improvement Proposal’’ or BIP. Such secured by cryptography known as per block; the reward decreased from proposals are generally posted on public-private key cryptography, twenty-five (25) bitcoin in July 2016 and websites, and the proposals explain represented by the bitcoin addresses 12.5 in May 2020. It is estimated to technical requirements for the protocol and digital signature in a transaction’s halve again at the start of 2024. This change as well as reasons why the data file. Each Bitcoin network address, deliberately controlled rate of bitcoin change should be accepted. Upon its or wallet, is associated with a unique creation means that the number of inclusion in the most recent version of ‘‘public key’’ and ‘‘private key’’ pair, bitcoin in existence will never exceed Bitcoin Core, a new BIP becomes part of both of which are lengthy alphanumeric twenty-one (21) million and that bitcoin the reference software’s Bitcoin codes, derived together and possessing cannot be devalued through excessive protocol. Several BIPs have been a unique relationship. The public key is production unless the Bitcoin network’s implemented since 2011 and have visible to the public and analogous to source code (and the underlying provided various new features and the Bitcoin network address. The protocol for bitcoin issuance) is altered. scaling improvements. private key is a secret and may be used As of January 1, 2021, approximately Because Bitcoin has no central to digitally sign a transaction in a way 18,587,000 bitcoin have been mined. It authority, updating the reference that proves the transaction has been is estimated that more than ninety (90) software’s Bitcoin protocol will not signed by the holder of the public- percent of the twenty-one (21) million immediately change the Bitcoin private key pair, without having to bitcoin will have been produced by network’s operations. Instead, the reveal the private key. 2022. implementation of a change is achieved The Bitcoin network incorporates a by users and miners downloading and system to prevent double-spending of a Bitcoin Value running updated versions of Bitcoin single bitcoin. To prevent the possibility According to the Registration Core or other Bitcoin software that of double-spending a single bitcoin, Statement, the value of Bitcoin is abides by the new Bitcoin protocol. each validated transaction is recorded, determined by the value that various Users and miners must accept any time stamped and publicly displayed in market participants place on Bitcoin changes made to the Bitcoin source code a ‘‘block’’ in the Blockchain, which is through their transactions. The most by downloading a version of their publicly available. Any user may common means of determining the Bitcoin software that incorporates the validate, through their Bitcoin wallet or value of a Bitcoin is by surveying one proposed modification of the Bitcoin a blockchain explorer, that each or more Bitcoin Exchanges where network’s source code. A modification transaction in the Bitcoin network was Bitcoin is traded publicly and of the Bitcoin network’s source code is authorized by the holder of the transparently (e.g., Bitstamp, Coinbase, only effective with respect to the Bitcoin applicable private key, and Bitcoin Kraken, itBit, and Gemini). users and miners that download it. If an network mining software consistent Additionally, in parallel to the open incompatible modification is accepted with reference software requirements bitcoin exchanges, informal ‘‘over-the- only by a percentage of users and typically validates each such transaction counter’’ or ‘‘OTC markets’’ for bitcoin miners, a division in the Bitcoin before including it in the Blockchain. trading also exist as a result of the peer- network will occur such that one Bitcoin Mining—Creation of New to-peer nature of the Bitcoin Network, network will run the pre-modification Bitcoins which allows direct transactions source code and the other network will between any seller and buyer. run the modified source code. Such a According to the Registration division is known as a ‘‘fork’’ in the Statement, the process by which On each exchange, bitcoin is traded Bitcoin network. bitcoins are created and bitcoin with publicly disclosed valuations for Such a fork in the Bitcoin network transactions are verified is called each executed trade, measured by one or occurred on August 1, 2017, when a mining. To begin mining, a user, or more fiat currencies such as the U.S. group of developers and miners ‘‘miner,’’ can download and run a dollar or Euro. OTC markets do not accepted certain changes to the Bitcoin mining client, which, like regular typically disclose their trade data. network software intended to increase Bitcoin network software, turns the Currently, there are many exchanges transaction capacity. Blocks mined on user’s computer into a ‘‘node’’ on the operating worldwide, and each such this network now diverge from blocks Bitcoin network that validates blocks. exchange represents a substantial mined on the Bitcoin network, which Each time transactions are validated and percentage of bitcoin buying and selling has resulted in the creation of a new bundled into new blocks added to the activity. These exchanges provide the blockchain whose digital asset is Blockchain, the Bitcoin network awards most data with respect to prevailing referred to as ‘‘bitcoin cash.’’ Bitcoin the miner solving such blocks with valuations of bitcoins. The below table and bitcoin cash now operate as newly issued bitcoin and any reflects the trading volume (in separate, independent networks, and transaction fees paid by bitcoin thousands of USD) of each of the bitcoin have distinct related assets (bitcoin and transaction senders. This reward system exchanges included in the Index as of bitcoin cash). Additional forks have is the method by which new bitcoins January 1, 2021 using data reported by followed the Bitcoin Cash fork, enter into circulation to the public. the Index Provider from January 1, 2020 including those for Bitcoin Gold and to January 1, 2021: Mathematically Controlled Supply Bitcoin SegWit2X, in the months after the creation of Bitcoin Cash. According to the Registration Bitcoin exchanges in the Total volume Statement, the method for creating new (in thousands index as of January 1, 2021 of USD) Bitcoin Transactions bitcoin is mathematically controlled in According to the Registration a manner so that the supply of bitcoin Bitstamp ...... $33,291,537 Statement, a bitcoin transaction grows at a limited rate pursuant to a pre- Coinbase ...... 63,462,664 contains the sender’s bitcoin address, set schedule. The number of bitcoin Gemini ...... 8,317,528 the recipient’s bitcoin address, the awarded for solving a new block is itBit ...... 2,775,916

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• Total volume The list is partitioned by timestamp into EST and almost always by 8:00 p.m. Bitcoin exchanges in the (in thousands 12 equally-sized time intervals of 5 (five) EST). The pause between 4:00 p.m. EST index as of January 1, 2021 of USD) minute length. • and 5:30 p.m. EST provides an For each partition separately, the opportunity to algorithmically detect, Kraken ...... 25,445,906 volume-weighted median trade price is calculated from the trade prices and sizes of flag, investigate, and correct unusual 133,293,551 all Relevant Transactions, i.e., across all pricing should it occur. The NAV for the Constituent Bitcoin Exchanges. A volume- Trust’s Shares will be disseminated Bitcoin futures contracts are traded on weighted median differs from a standard daily to all market participants at the the Chicago Mercantile Exchange (the median in that a weighting factor, in this case same time. The Sponsor anticipates that ‘‘CME’’) and other exchanges. However, trade size, is factored into the calculation. the Index will be reflective of a • The Index is then determined by the the Trust will not hold or trade in reasonable valuation of the average spot arithmetic mean of the volume-weighted price of bitcoin. However, in the event commodity futures contracts or other medians of all partitions. derivative contracts regulated by the the Index is not available or determined Commodities Exchange Act,8 as By employing the foregoing steps, the by the Sponsor to not be reliable, the administered by the Commodity Futures Index thereby seeks to ensure that Sponsor would ‘‘fair value’’ the Trust’s Trading Commission (the ‘‘CFTC’’). transactions in bitcoin conducted at bitcoin holdings. The Sponsor does not outlying prices do not have an undue anticipate that the need to ‘‘fair value’’ The Index effect on the value of a specific bitcoin will be a common occurrence. As described in the Registration partition, large trades or clusters of The Sponsor will publish the NAV and Statement, the Fund will use the Index trades transacted over a short period of NAV per Share at www.valkyriefunds.io to calculate the Trust’s NAV. The Index time will not have an undue influence as soon as practicable after their is not affiliated with the Sponsor and on the index level, and the effect of determination and availability. was created and is administered by CF large trades at prices that deviate from Intraday Indicative Value Benchmarks Ltd. (the ‘‘Benchmark the prevailing price are mitigated from Administrator’’), an independent entity, having an undue influence on the In order to provide updated to facilitate financial products based on benchmark level. In addition, the information relating to the Trust for use bitcoin. The Index is designed based on Sponsor notes that an oversight function by Shareholders and market the IOSCO Principals for Financial is implemented by the Benchmark professionals, the Trust will disseminate Benchmarks and serves as a once-a-day Administrator in seeking to ensure that an updated intraday indicative value benchmark rate of the U.S. dollar price the Index is administered through (‘‘IIV’’) per Share updated every 15 of bitcoin (USD/BTC), calculated as of 4 codified policies for Index integrity. seconds by one of more major market p.m. Eastern time. The Index is based on According to the Registration data vendors during the Exchange’s materially the same methodology Statement, the Index provides an Core Trading Session.11 The IIV will be (except calculation time) 9 as the accurate reference to the average spot calculated by a third-party financial Benchmark Administrator’s CME CF price of Bitcoin and the methodology data provider during the Exchange’s Bitcoin Reference Rate (the ‘‘BRR’’), employed in constructing the Index, Core Trading Session. The IIV will be which was first introduced on specifically its use of medians in calculated by using the prior day’s November 14, 2016 and is the rate on filtering out small trades, makes the closing NAV per Share of the Trust as which bitcoin futures contracts are cash- Index more resistant to manipulation a base and updating that value settled in U.S. dollars at the CME. The than other measurements that employ throughout the trading day to reflect Index aggregates the trade flow of different methodologies. In addition, the changes in the most recently reported several bitcoin exchanges, during an Index included over $133,293,551,000 price level of the CME CF Bitcoin Real- observation window between 3:00 p.m. billion in bitcoin trades (approximately Time Index (‘‘BRTI’’), as reported by and 4:00 p.m. Eastern time into the U.S. 16,304,168 bitcoins) during the one-year CME Group, Inc., Bloomberg, L.P. or dollar price of one bitcoin at 4:00 p.m. period ended December 31, 2020. another reporting service. The BRTI is Eastern time. The current constituent Finally, an oversight committee is calculated in real time based on the bitcoin exchanges of the Index are responsible for regularly reviewing and Relevant Order Books of all Constituent Bitstamp, Coinbase, Gemini, itBit and overseeing the methodology, practice, Bitcoin Exchanges. A ‘‘Relevant Order Kraken (the ‘‘Constituent Bitcoin standards and scope of the Index to Book’’ is the universe of the currently Exchanges’’). ensure that it continues to accurately unmatched limit orders to buy or sell in The Index is calculated based on the track the spot prices of Bitcoin. the BTC/USD pair that is reported and 10 ‘‘Relevant Transactions’’ of all of its Calculation of Net Asset Value disseminated by CF Benchmarks Ltd., as Constituent Bitcoin Exchanges, as the BRTI calculation agent. follows: The Trust’s net asset value (‘‘NAV’’) is calculated by taking the current market Creation and Redemption of Shares • All Relevant Transactions are added to a joint list, recording the time of execution, value of its total assets, less any According to the Registration trade price and size for each transaction. liabilities of the Trust, and dividing that Statement, the Trust will issue Shares total by the total number of outstanding on an ongoing basis, but only in one or 8 7 U.S.C. 1. Shares. The bitcoin held by the Trust more Baskets. The creation and 9 The Index is calculated as of 4 p.m. Eastern will be valued based on the price set by redemption of a Basket requires the Time, whereas the BRR is calculated as of 4 p.m. the Index. The Administrator will delivery to the Trust, or the distribution London Time. calculate the NAV of the Trust once by the Trust, of the number of whole 10 A ‘‘Relevant Transaction’’ is any cryptocurrency versus U.S. dollar spot trade that each Exchange trading day. The and fractional bitcoins represented by occurs during the observation window between Exchange’s Core Trading Session closes 3:00 p.m. and 4:00 p.m. Eastern time on a at 4:00 p.m. EST. The NAV for a normal 11 Several major market data vendors display and/ Constituent Bitcoin Exchange in the BTC/USD pair trading day will be released after the or make widely available IIVs taken from the that is reported and disseminated by a Constituent Consolidated Tape Association (‘‘CTA’’) or other Bitcoin Exchange through its publicly available API end of the Core Trading Session. data feeds. In addition, the indicative fund value and observed by the Benchmark Administrator, CF However, NAVs are not officially struck will be available through on-line information Benchmarks Ltd. until later in the day (often by 5:30 p.m. services such as Bloomberg and Reuters.

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each Basket being created or redeemed, of, and capabilities in, execution, creation order. The Liquidity Provider the number of which is determined by clearance and settlement. In the event will then (i) determine the Cash dividing the number of bitcoins owned that an order cannot be filled in its Exchange Rate, which, in the case of a by the Trust at 4:00 p.m., New York entirety by a single Liquidity Provider, creation order, is the Index spot price at time, on the trade date of a creation or additional Liquidity Provider(s) will be the time at which the Cash Collateral redemption order, as adjusted for the selected by the Sponsor to fill the Amount is received by the number of whole and fractional bitcoins remaining amount based on the criteria Administrator, plus the 1% Liquidity constituting accrued but unpaid fees above. Provider Fee, and (ii) provide a firm and expenses of the Trust, by the quote to the Authorized Participant for Creation Procedures number of Shares outstanding at such the Total Basket Bitcoin Amount, time (the quotient so obtained According to the Registration determined by using the Cash Exchange calculated to one-hundred-millionth of Statement, on any Business Day, an Rate. If the Liquidity Provider’s quote is one bitcoin), and multiplying such Authorized Participant may order one or greater than the Cash Collateral Amount quotient by 50,000 (the ‘‘Basket Bitcoin more Creation Baskets from the Trust by received, the Authorized Participant Amount’’). The Basket Bitcoin Amount placing a creation order with the will be required to pay the difference on multiplied by the number of Baskets Administrator. Creation orders may be the same day. Under the Conversion being created or redeemed is the ‘‘Total placed either ‘‘in-kind’’ or ‘‘in-cash.’’ Procedures, the Authorized Participant Basket Bitcoin Amount.’’ Creation orders must be placed no later does not pay more than the firm quote According to the Registration than 3:59:59 p.m., New York time, for provided by the Liquidity Provider. The Statement, Authorized Participants are in-kind creations, and 4:59:59 p.m., Liquidity Provider bears the risk of any the only persons that may place orders New York time, for in-cash creations, on change in the Total Basket Bitcoin to crate or redeem Baskets. Each each Business Day. Authorized Amount and of any change in the price Authorized Participant must (i) be a Participants may only create Baskets of bitcoin once the Cash Exchange Rate registered broker-dealer, (ii) enter into a and cannot create any Shares in an has been determined. Provided that Participant Agreement with the amount less than a Basket. payment for the Total Basket Bitcoin Sponsor, the Administrator, the In-Kind Creations Amount is received by the Marketing Agent and the Liquidity Administrator, the Liquidity Provider Providers and (iii) in the case of the In-kind creations will take place as will deliver the bitcoins to the creation or redemption of Baskets that follows, where ‘‘T’’ is the trade date and Custodian on the settlement date on do not use the Conversion Procedures, each day in the sequence is a Business behalf of the Authorized Participant. own a bitcoin wallet address that is Day: After the Custodian receives the Total recognized by the Custodian as Basket Bitcoin Amount, the belonging to the Authorized Participant T • Administrator will instruct the Transfer (an ‘‘Authorized Participant Self- The Authorized Participant places a Agent to deliver the Creation Baskets to Administered Account’’). Authorized creation order with the Administrator. the Authorized Participant. The • The Marketing Agent accepts (or Participants may act for their own Administrator will then send the rejects) the creation order, which is accounts or as agents for broker-dealers, Liquidity Provider the cash equal to the communicated to the Authorized custodians and other securities market Cash Exchange Rate times the Total Participant by the Administrator. participants that wish to create or Basket Bitcoin Amount, plus the 1% redeem Baskets. Shareholders who are • The Total Basket Bitcoin Amount is Liquidity Provider Fee. The not Authorized Participants will only be determined as soon as practicable after Administrator will return any remaining able to redeem their Shares through an 4:00 p.m., New York time. amount of the Cash Collateral Amount Authorized Participant. Although the Trust will create Baskets T+1 to the Authorized Participant. only upon the receipt of bitcoins, and • The Authorized Participant Redemption Procedures will redeem Baskets only by distributing transfers the Total Basket Bitcoin bitcoins, an Authorized Participant may Amount from its Authorized Participant According to the Registration deposit cash with the Administrator, Self-Administered Account to the Statement, the procedures by which an which will facilitate the purchase or Custodian. Authorized Participant can redeem one sale of bitcoins through a Liquidity • Once the Total Basket Bitcoin or more Baskets mirror the procedures Provider on behalf of an Authorized Amount is received by the Custodian, for the creation of Baskets. On any Participant (the ‘‘Conversion the Administrator directs the Transfer Business Day, an Authorized Participant Procedures’’). Liquidity Providers must Agent to credit the Creation Baskets to may place a redemption order (i) enter into a Participant Agreement the Authorized Participant’s DTC specifying the number of Redemption with the Sponsor, the Administrator, the account. Baskets to be redeemed. Redemption Marketing Agent and each Authorized orders may be placed either ‘‘in-kind’’ In-Cash Creations Participant and (ii) own a Liquidity or ‘‘in-cash.’’ Redemption orders must Provider Account. Upon receiving instruction from the be placed no later than 3:59:59 p.m., The Conversion Procedures will be Administrator that a creation order has New York time, for in-kind facilitated by a single Liquidity been accepted by the Marketing Agent, redemptions, and 4:59:59 p.m., New Provider. On an order-by-order basis, the Authorized Participant will send York time, for in-cash redemption, on the Sponsor will select the Liquidity 110% of the U.S. Dollar value of the each Business Day. Authorized Provider that it believes will provide the Total Basket Bitcoin Amount, as Participants may only redeem Baskets best execution of the Conversion calculated using the most recently and cannot redeem any Shares in an Procedures, and will base its decision published Bitcoin Index Price (the amount less than a Basket. on factors such as the Liquidity ‘‘Cash Collateral Amount’’). Once the In-Kind Redemptions Provider’s creditworthiness, financial Cash Collateral Amount is received by stability, the timing and speed of the Administrator, the Sponsor will In-kind redemptions will take place as execution, liquidity and the likelihood notify the Liquidity Provider of the follows, where ‘‘T’’ is the trade date and

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each day in the sequence is a Business Potential Manipulation in the Bitcoin bitcoin ecosystem has matured Day: Market considerably since the last time the Commission reviewed a proposal for a T In prior orders relating to the listing of products on U.S. exchanges, the bitcoin ETF. The Sponsor notes below • The Authorized Participant places a Commission Staff expressed its concern the advancement of the application of redemption order with the that the global market for bitcoin may be the Index (as described below) over that Administrator. subject to potential manipulation.12 In same period of time, including how the Index articulates the potential remedy • The Marketing Agent accepts (or order for any proposed rule change from an exchange to be approved, the that it can be to sufficiently mitigate the rejects) the redemption order. Commission must determine that, pricing issues and various risks • The Total Basket Bitcoin Amount is among other things, the proposal is surrounding market manipulation. determined as soon as practicable after consistent with the requirements of Price Manipulation and Market Integrity 4:00 p.m., New York time. Section 6(b)(5) of the Act. The Exchange According to the Sponsor, the bitcoin believes that this proposal is consistent T+1 market has experienced significant with the requirements of Section 6(b)(5) maturity as adoption pressure has • of the Act and that the Sponsor’s The Authorized Participant delivers broadened from both retail and representations below sufficiently to the Transfer Agent Redemption institutional clients on a global demonstrate that the manipulation Baskets from its DTC account. perspective. There has been concern concerns previously articulated by the • over whether cryptocurrency exchanges Once the Redemption Baskets are Commission are mitigated by investor have mechanisms in place to report and received by the Transfer Agent, the protection issues. Custodian transfers the Total Basket According to the Sponsor, the bitcoin remediate price and overall, ensure Bitcoin Amount to the Authorized marketplace has matured rapidly in market integrity. As the industry has Participant and the Transfer Agent recent years regarding user growth, grown exponentially and the number of cancels the Shares. market capitalization, volume, market marketplaces expands, it follows that participants, and liquidity shifts. The the quality of several factors of these In-Cash Redemptions Sponsor notes that Coinbase alone marketplaces will vary. This notion is amplified for exchanges in some To redeem Baskets using the enables access to cryptocurrency exchange or professional custodial jurisdictions that are unregulated or Conversion Procedures, Authorized decentralized. Therefore, the Sponsor Participants will send the Administrator solutions to over 43 million retail users as well as 7,000 institutions. The believes that there must be sufficiency a redemption order. The Marketing of data inputs for the calculation of the Agent will accept or reject the Sponsor further notes that the bitcoin market has seen a dramatic shift from spot price of bitcoin. In turn the data redemption order on that same date. A retail-driven growth to institutional must be provided under licensing Liquidity Provider will then (i) involvement. Large, publicly-traded arrangements with each exchange, who determine the Cash Exchange Rate, companies such as Tesla and in turn meet strict entry criteria. The which, in the case of a redemption MicroStrategy have purchased bitcoin to design choices within the methodology order, is the Index spot price minus the hold on corporate balance sheets. The and framework of the Index are 1% Liquidity Provider Fee at the time Sponsor additionally notes that, sufficiently resistant to market at which the Administrator notifies the typically, in a thinly traded asset, it manipulation while providing oversight Authorized Participant that an order has would not be feasible to trade in as large managed by an independent committee. According to the Sponsor, the Index been accepted and (ii) provide a firm of quantities without causing is the aggregation of executed trade data quote to an Authorized Participant for corresponding spikes in price action. for major bitcoin spot exchanges. To be the Total Basket Bitcoin Amount, According to the Sponsor, asset eligible for inclusion in the Index, a determined by using the Cash Exchange managers alongside numerous Constituent Bitcoin Exchange must Rate. Under the Conversion Procedures, corporations around the world have facilitate spot trading of bitcoin against the Authorized Participant does not been able to obtain bitcoin, at times the U.S. Dollar and make trade data and receive less than the firm quote surpassing billion-dollar notional order data available through an API provided by the Liquidity Provider. The values, without significantly distorting with sufficient reliability, relevant data, the marketplace. As provided below, the Liquidity Provider bears the risk of any and appropriate speed. The volume for change in the Total Basket Bitcoin spot trading must meet a minimum Amount and of any change in the price 12 See Securities Exchange Act Release Nos. 80206 (Mar. 10, 2017), 82 FR 14076 (Mar. 16, 2017) threshold when compared to the total of bitcoin once the Cash Exchange Rate (SR–BatsBZX–2016–30) (Order Disapproving a volume of all Constituent Bitcoin has been determined. The Liquidity Proposed Rule Change, as Modified by Exchanges included in the Index. To be Provider will send the Administrator Amendments No. 1 and 2, to BZX Rule 14.11(e)(4), considered, an exchange must also the cash proceeds equal to the Cash Commodity-Based Trust Shares, To List and Trade Shares Issued by the Winklevoss Bitcoin Trust) enforce policies to ensure fair and Exchange Rate times the Total Basket (‘‘Winklevoss I’’); and 83723 (July 26, 2018), 83 FR transparent market conditions and have Bitcoin Amount, minus the 1% 37579 (August 1, 2018) (SR–BatsBZX–2016–30) processes in place to impede illegal, or Liquidity Provider Fee. Once the (Order Setting Aside Action by Delegated Authority and Disapproving a Proposed Rule Change, as manipulative trading practices. Authorized Participant delivers the Modified by Amendments No. 1 and 2, To List and Additionally, to be included as a Redemption Baskets to the Transfer Trade Shares of the Winklevoss Bitcoin Trust) constituent in the Index, each Agent, the Administrator will send the (‘‘Winklevoss II’’); see also Securities Exchange Act Constituent Bitcoin Exchange must Release No. 88284 (February 26, 2020), 85 FR 12595 cash proceeds to the Authorized (March 3, 2020) (SR–NYSEArca–2019–39) (Order comply with applicable law and Participant and the Transfer Agent will Disapproving a Proposed Rule Change, as Modified regulation, including proper AML/KYC cancel the Shares. At the instruction of by Amendment No. 1, To Amend NYSE Arca Rule procedures. According to the Sponsor, the Administrator, the Custodian will 8.201–E (Commodity-Based Trust Shares) and To the BRR, which uses an identical List and Trade Shares of the United States Bitcoin then send the Liquidity Provider the and Treasury Investment Trust Under NYSE Arca methodology as the Index except with Total Basket Bitcoin Amount. Rule 8.201–E). respect to is calculation times, is the

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settlement index for the regulated evidence has been presented of the recently complete calendar year and the futures contracts listed by CME Group, provider failing to maintain processes most recently completed calendar Kraken Futures, as well as being the and controls to prevent manipulation by quarters since that year; (f) a line graph pricing source for various NAV its organization.13 If such a showing the Shares’ premiums or determinations for investment products manipulation were to occur, it would be discounts for the most recently offered by major financial institutions. quickly detected by the CME, and completed calendar year and the most According to the Sponsor, the hundreds of sophisticated market recently completed calendar quarters Calculation Agent of the Index further participants, as the Index formula and since that year (or the life of the ascertains the presence of fair and the data sources are both publicly exchange-traded fund, if shorter); (g) the transparent market conditions and available.14 Finally, according to the prospectus; and (h) other applicable processes to identify and impede illegal, Sponsor, the CFTC has been quantitative information. unfair, or manipulative practices by successfully exercising its enforcement The Trust’s website will be publicly conducting a thorough review of any authority related to fraud and available prior to the public offering of spot bitcoin exchange under manipulation on the Constituent Bitcoin Shares and accessible at no charge. consideration for inclusion as a Exchanges.15 In addition, any platform The Index value is available on the CF Constituent Bitcoin Exchange. that is accepted by the CME to become Benchmarks website and from major According to the Sponsor, the part of the constituent trading platforms market data vendors. The spot price of arrangements of all Constituent Bitcoin that are used to calculate the Index or bitcoin also is available on a 24-hour Exchanges are reviewed regularly to the CME CF BRR, including the basis from major market data vendors. ensure that they continue to meet all Constituent Platforms, (1) must enter Trading Halts criteria. into a data sharing agreement with the The Sponsor notes that, currently, the CME, (2) must cooperate with inquiries With respect to trading halts, the Constituent Bitcoin Exchanges currently and investigations of regulators and the Exchange may consider all relevant included in the Index are Bitstamp, Benchmark Administrator and (3) must factors in exercising its discretion to Coinbase, Gemini, itBit and Kraken. The submit each of its clients to its Know- halt or suspend trading in the Shares of Sponsor further notes that after Your-Customer (‘‘KYC’’) procedures; the Trust.17 Trading in Shares of the ascertaining API data from these therefore, the CME would be able, in the Trust will be halted if the circuit breaker exchanges, the information is aggregated case of any suspicious trades, to parameters in NYSE Arca Rule 7.12–E from actual trade data in a manner discover all material trade information have been reached. Trading also may be designed to resist manipulation. including the identities of the customers halted because of market conditions or Partitions are utilized to ensure large placing the trades. for reasons that, in the view of the individual trades have a limited effect Exchange, make trading in the Shares on the price of the Index by only Availability of Information inadvisable. influencing the volume-weighted The website for the Trust The Exchange may halt trading during median for a particular partition. Use of (www.valkyriefunds.io) will contain the the day in which an interruption to the volume-weighted medians, as opposed following information, on a per Share dissemination of the IIV or the value of to volume-weighted means, verifies that basis, for the Trust: (a) The current NAV the Index occurs. If the interruption to transactions conducted at outlying per Share daily and the prior business the dissemination of the IIV or the value prices do not have an excessive effect on day’s NAV and the reported closing of the Index persists past the trading day the value of a partition. The Index price; (b) the Official Closing Price; 16 (c) in which it occurred, the Exchange will weights each partition equally as well as midpoint of the national best bid and halt trading no later than the beginning equal weighting of each exchange that is the national best offer (‘‘NBBO’’) as of of the trading day following the a part of the Index. In the event of an the time the NAV is calculated (‘‘Bid- interruption. In addition, if the instance of index calculation in which Ask Price’’); (d) calculation of the Exchange becomes aware that the NAV a Constituent Bitcoin Exchange’s premium or discount of the Official with respect to the Shares is not volume-weighted median transaction Closing Price against such NAV disseminated to all market participants price exhibits an absolute percentage expressed as a percentage of such NAV; at the same time, it will halt trading in deviation from the volume-weighted (e) a table showing the number of days the Shares until such time as the NAV median price of other Constituent the Shares of the Trust traded at a is available to all market participants. Bitcoin Exchange transactions greater premium or discount during the most Trading Rules than the potentially erroneous data parameter (10%), then transactions from 13 See CME CF Cryptocurrency Pricing Products The Exchange deems the Shares to be that Constituent Bitcoin Exchange are Oversight Committee (July 31, 2020), available at: equity securities, thus rendering trading https://docs-cfbenchmarks.s3.amazonaws.com/ in the Shares subject to the Exchange’s deemed potentially erroneous and CME+CF+Oversight+Committee+Charter.pdf. excluded from the index calculation. 14 See CME CF Cryptocurrency Reference Rates existing rules governing the trading of Methodology Guide (July 31, 2020), available at: equity securities. Shares will trade on Index Price Manipulation https://docs-cfbenchmarks.s3.amazonaws.com/ the NYSE Arca Marketplace from 4:00 According to the Sponsor, to date, CME+CF+Reference+Rates+Methodology.pdf. a.m. to 8:00 p.m. E.T. in accordance 15 See e.g., CFTC Rel. No. 8369–21, ‘‘CFTC Orders there has been no evidence that the Coinbase Inc. to Pay $6.5 Million for False, with NYSE Arca Rule 7.34–E (Early, Index has been subject to manipulation. Misleading, or Inaccurate Reporting and Wash Core, and Late Trading Sessions). The The Sponsor notes that, in order for the Trading’’ (March 19, 2021); and ‘‘Remarks of Exchange has appropriate rules to Index to be manipulated, one or both of Commissioner Dawn D. Stump Before Texas A&M’s facilitate transactions in the Shares Bitcoin Conference’’ (April 16, 2021), available at: the following must be true: (a) The https://cftc.gov/PressRoom/SpeechesTestimony/ during all trading sessions. As provided Index provider is manipulating the opastump7. in NYSE Arca Rule 7.6–E, the minimum Index, or (b) the prices being fed to the 16 The term ‘‘Official Closing Price’’ is defined in price variation (‘‘MPV’’) for quoting and Index provider are being manipulated NYSE Arca Rule 1.1(ll) as the reference price to entry of orders in equity securities determine the closing price in a security for by their sources. The Sponsor notes that purposes of Rule 7–E Equities Trading, and the traded on the NYSE Arca Marketplace is the CME participates in the oversight procedures for determining the Official Closing committee of the Index, and no Price are set forth in that rule. 17 See NYSE Arca Rule 7.12–E.

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$0.01, with the exception of securities entities that are members of ISG or with alone bitcoin. The proposed rule change that are priced less than $1.00 for which which the Exchange has in place a is designed to prevent fraudulent and the MPV for order entry is $0.0001. comprehensive surveillance sharing manipulative acts and practices The Shares will conform to the initial agreement (‘‘CSSA’’).20 The Exchange is because, although the global Bitcoin and continued listing criteria under also able to obtain information regarding market is not inherently resistant to NYSE Arca Rule 8.201–E. The trading of trading in the Shares in connection with fraud and manipulation, the Index used the Shares will be subject to NYSE Arca ETP Holders’ proprietary or customer by the Trust to determine the value of Rule 8.201–E(g), which sets forth certain trades which they effect through ETP its bitcoin assets and its NAV, serves as restrictions on Equity Trading Permit Holders on any relevant market. a benchmark mechanism sufficient to (‘‘ETP’’) Holders acting as registered In addition, the Exchange also has a mitigate the impact of instances of fraud Market Makers in Commodity-Based general policy prohibiting the and manipulation on a reference price Trust Shares to facilitate surveillance. distribution of material, non-public for Bitcoin. As discussed above, while The Exchange represents that, for initial information by its employees. bitcoin is listed and traded on a number and continued listing, the Trust will be All statements and representations of markets and platforms, the Index in compliance with Rule 10A–3 18 under made in this filing regarding (a) the exclusively utilizes its Constituent the Act, as provided by NYSE Arca Rule description of the portfolio of the Trust, Bitcoin Exchanges to determine the 5.3–E. A minimum of 100,000 Shares of (b) limitations on portfolio holdings or value of the Index. Therefore, use of the the Trust will be outstanding at the reference assets, or (c) the applicability Index would mitigate the effects of commencement of trading on the of Exchange listing rules specified in potential manipulation of the bitcoin Exchange. this rule filing shall constitute market. Bitcoin trades in a well- continued listing requirements for Surveillance arbitraged and distributed market. The listing the Shares on the Exchange. linkage between the bitcoin markets and The Exchange represents that trading The issuer has represented to the the presence of arbitrageurs in those in the Shares of the Trust will be subject Exchange that it will advise the markets means that the manipulation of to the existing trading surveillances Exchange of any failure by the Trust to the price of bitcoin on any Constituent administered by the Exchange, as well comply with the continued listing Platform would likely require as cross-market surveillances requirements, and, pursuant to its overcoming the liquidity supply of such administered by FINRA on behalf of the obligations under Section 19(g)(1) of the arbitrageurs who are potentially Exchange, which are designed to detect Act, the Exchange will monitor for eliminating any cross-market pricing violations of Exchange rules and compliance with the continued listing differences. applicable federal securities laws.19 The requirements. If the Trust is not in In addition, the Exchange has in place Exchange represents that these compliance with the applicable listing surveillance procedures that are procedures are adequate to properly requirements, the Exchange will adequate to properly monitor trading in monitor Exchange trading of the Shares commence delisting procedures under the Shares in all trading sessions and to in all trading sessions and to deter and NYSE Arca Rule 5.5–E(m). deter and detect violations of Exchange detect violations of Exchange rules and 2. Statutory Basis rules and applicable federal securities federal securities laws applicable to laws. The Exchange or FINRA, on behalf trading on the Exchange. The basis under the Act for this of the Exchange, or both, will The surveillances referred to above proposed rule change is the requirement communicate as needed regarding 21 generally focus on detecting securities under Section 6(b)(5) that an trading in the Shares with other markets trading outside their normal patterns, exchange have rules that are designed to that are members of the ISG, and the which could be indicative of prevent fraudulent and manipulative Exchange or FINRA, on behalf of the manipulative or other violative activity. acts and practices, to promote just and Exchange, or both, may obtain trading When such situations are detected, equitable principles of trade, to remove information regarding trading in the surveillance analysis follows and impediments to, and perfect the Shares and bitcoin futures with other investigations are opened, where mechanism of a free and open market markets and other entities that are appropriate, to review the behavior of and, in general, to protect investors and members of the ISG, and the Exchange all relevant parties for all relevant the public interest. or FINRA, on behalf of the Exchange, or trading violations. The Exchange believes that the both, may obtain trading information The Exchange or FINRA, on behalf of proposed rule change is designed to regarding trading in the Shares and the Exchange, or both, will prevent fraudulent and manipulative bitcoin futures from such markets and communicate as needed regarding acts and practices in that the Shares will other entities. In addition, the Exchange trading in the Shares and bitcoin futures be listed and traded on the Exchange may obtain information regarding with other markets and other entities pursuant to the initial and continued trading in the Shares from markets that that are members of the ISG, and the listing criteria in NYSE Arca Rule are members of ISG or with which the Exchange or FINRA, on behalf of the 8.201–E. Investing in the Trust will Exchange has in place a CSSA. Also, Exchange, or both, may obtain trading provide investors with exposure to pursuant to NYSE Arca Rule 8.201–E(g), information regarding trading in the bitcoin in a manner that is more the Exchange is able to obtain Shares and bitcoin futures from such efficient and convenient than the information regarding trading in the markets and other entities. In addition, purchase of stand-alone bitcoin, while Shares and the underlying bitcoin or the Exchange may obtain information also mitigating some of the risk by any bitcoin derivative through ETP regarding trading in the Shares and reducing the volatility typically Holders acting as registered Market bitcoin futures from markets and other associated with the purchase of stand- Makers, in connection with such ETP Holders’ proprietary or customer trades 18 17 CFR 240.10A–3. 20 For a list of the current members of ISG, see through ETP Holders which they effect 19 FINRA conducts cross-market surveillances on www.isgportal.org. The Exchange notes that not all on any relevant market. behalf of the Exchange pursuant to a regulatory components of the Trust may trade on markets that services agreement. The Exchange is responsible for are members of ISG or with which the Exchange has The proposed rule change is designed FINRA’s performance under this regulatory services in place a CSSA. to promote just and equitable principles agreement. 21 15 U.S.C. 78f(b)(5). of trade and to protect investors and the

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public interest in that there is a into a CSSA. In addition, as noted • Send an email to rule-comments@ considerable amount of bitcoin price above, investors will have ready access sec.gov. Please include File Number SR– and market information available on to information regarding the Trust’s NYSEArca–2021–31 on the subject line. public websites and through bitcoin holdings, the IIV, and quotation Paper Comments professional and subscription services. and last sale information for the Shares. Investors may obtain, on a 24-hour • Send paper comments in triplicate B. Self-Regulatory Organization’s basis, bitcoin pricing information based to Secretary, Securities and Exchange on the spot price for bitcoin from Statement on Burden on Competition Commission, 100 F Street NE, various financial information service The Exchange does not believe that Washington, DC 20549–1090. providers. The closing price and the proposed rule change will impose All submissions should refer to File settlement prices of bitcoin are readily any burden on competition that is not Number SR–NYSEArca-2021–31. This available from the Bitcoin exchanges necessary or appropriate in furtherance file number should be included on the and other publicly available websites. In of the purpose of the Act. The Exchange subject line if email is used. To help the addition, such prices are published in notes that the proposed rule change will Commission process and review your public sources, or on-line information facilitate the listing and trading of an comments more efficiently, please use services such as Bloomberg. The Trust exchange-traded product based on the only one method. The Commission will will provide website disclosure of its price of bitcoin, which will enhance post all comments on the Commission’s bitcoin holdings daily. Quotation and competition among market participants, internet website (http://www.sec.gov/ last-sale information regarding the to the benefit of investors and the rules/sro.shtml). Copies of the Shares will be disseminated through the marketplace. submission, all subsequent facilities of the CTA. The IIV will be amendments, all written statements widely disseminated on a per Share C. Self-Regulatory Organization’s Statement on Comments on the with respect to the proposed rule basis every 15 seconds during the NYSE change that are filed with the Arca Core Trading Session (normally Proposed Rule Change Received From Members, Participants, or Others Commission, and all written 9:30 a.m., E.T., to 4:00 p.m., E.T.) by one communications relating to the or more major market data vendors. In No written comments were solicited proposed rule change between the addition, the IIV will be available or received with respect to the proposed Commission and any person, other than through on-line information services. rule change. those that may be withheld from the The Exchange represents that the public in accordance with the Exchange may halt trading during the III. Date of Effectiveness of the provisions of 5 U.S.C. 552, will be day in which an interruption to the Proposed Rule Change and Timing for available for website viewing and dissemination of the IIV or the Index Commission Action printing in the Commission’s Public value occurs. If the interruption to the Within 45 days of the date of Reference Room, 100 F Street NE, dissemination of the IIV or the Index publication of this notice in the Federal Washington, DC 20549 on official value persists past the trading day in Register or up to 90 days (i) as the business days between the hours of which it occurred, the Exchange will Commission may designate if it finds 10:00 a.m. and 3:00 p.m. Copies of the halt trading no later than the beginning such longer period to be appropriate filing also will be available for of the trading day following the and publishes its reasons for so finding inspection and copying at the principal interruption. In addition, if the or (ii) as to which the self-regulatory office of the Exchange. All comments Exchange becomes aware that the NAV organization consents, the Commission received will be posted without change. with respect to the Shares is not will: Persons submitting comments are disseminated to all market participants (A) By order approve or disapprove cautioned that we do not redact or edit at the same time, it will halt trading in the proposed rule change, or personal identifying information from the Shares until such time as the NAV (B) institute proceedings to determine comment submissions. You should is available to all market participants. whether the proposed rule change submit only information that you wish The proposed rule change is designed should be disapproved. to make available publicly. All to perfect the mechanism of a free and submissions should refer to File open market and, in general, to protect IV. Solicitation of Comments Number SR–NYSEArca–2021–31 and investors and the public interest in that Interested persons are invited to should be submitted on or before June it will facilitate the listing and trading submit written data, views, and 2, 2021. of an additional type of exchange-traded arguments concerning the foregoing, product that will enhance competition including whether the proposed rule For the Commission, by the Division of among market participants, to the change is consistent with the Act. Trading and Markets, pursuant to delegated 22 benefit of investors and the marketplace. Comments may be submitted by any of authority. As noted above, the Exchange has in the following methods: J. Matthew DeLesDernier, place surveillance procedures relating to Assistant Secretary. Electronic Comments trading in the Shares and may obtain [FR Doc. 2021–09969 Filed 5–11–21; 8:45 am] information via ISG from other • Use the Commission’s internet BILLING CODE 8011–01–P exchanges that are members of ISG or comment form (http://www.sec.gov/ with which the Exchange has entered rules/sro.shtml); or 22 17 CFR 200.30–3(a)(12).

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SECURITIES AND EXCHANGE The Commission received no comments The Exchanges recently amended COMMISSION on the proposed rule changes. Options C and D, which offer 10 Gb This order institutes proceedings connections to the LCN and IP [Release No. 34–91785; File Nos. SR–NYSE– under Section 19(b)(2)(B) of the networks, to also offer, at no additional 2021–05, SR–NYSEAMER–2021–04, SR– 6 NYSEArca–2021–07, SR–NYSECHX–2021– Exchange Act to determine whether to cost, two 10 Gb connections to the NMS 01, SR–NYSENAT–2021–01] approve or disapprove the proposed Network, an alternate dedicated rule changes. network connection that Users could Self-Regulatory Organizations; New II. Description of the Proposed Rule use to access the NMS feeds for which York Stock Exchange LLC, NYSE Changes the Securities Industry Automation American LLC, NYSE Arca, Inc., NYSE Corporation is engaged as the securities Chicago, Inc., and NYSE National, Inc.; The Exchanges, as part of their co- information processor.12 The Exchanges Order Instituting Proceedings To location services, currently offer Users 7 now propose to add two new Partial Determine Whether To Approve or four Partial Cabinet Solutions bundles, Cabinet Solution bundles: Proposed Disapprove Proposed Rule Changes labeled Options A, B, C, and D. Options Options E and F would offer a 40 Gb To Amend the Exchange’s Price List A and B include a partial cabinet connection to the LCN network and a 40 Related to Co-Location To Establish powered to either one or two kilowatts Gb connection to the IP network, and Two Additional Partial Cabinet (‘‘kW’’); a 1 Gb connection to the two 40 Gb connections to the NMS Solution Bundles liquidity center network (‘‘LCN’’) and a Network. Otherwise, proposed Options 1 Gb connection to the internet protocol E and F would be the same as the May 6, 2021. (‘‘IP’’) network, two fiber cross Options C and D bundles, offering a 1 I. Introduction connections, and connectivity to one of kW (Option E) or 2 kW (Option F) two time feeds.8 Options C and D partial cabinet, two fiber cross connects, On January 19, 2021, New York Stock include a 10 Gb connection to the LCN and either the Network Time Protocol Exchange LLC (‘‘NYSE’’), NYSE Network and a 10 GB connection to the Feed or the Precision Timing Protocol.13 American LLC (‘‘NYSE American’’), IP network and are otherwise the same The Exchanges state that, currently, NYSE Arca, Inc. (‘‘NYSE Arca’’), NYSE 9 as Options A and B. The Exchanges Users who are interested in Partial Chicago, Inc. (‘‘NYSE Chicago’’), and state that the Partial Cabinet Solution Cabinet Solution bundles, either NYSE National, Inc. (‘‘NYSE National’’) bundles are designed to attract smaller because they have minimal power and (collectively, the ‘‘Exchanges’’) each Users, including those with minimal cabinet space demands or because the filed with the Securities and Exchange power or cabinet space demands or costs attendant with having a dedicated Commission (‘‘Commission’’), pursuant those for which the costs of having a cabinet are too burdensome, cannot to Section 19(b)(1) of the Securities dedicated cabinet are too burdensome.10 access 40 Gb connections and are Exchange Act of 1934 (‘‘Exchange Act’’ To purchase a bundle, Users must pay 1 2 limited to the 10 Gb connections offered or ‘‘Act’’) and Rule 19b–4 thereunder, an initial charge and a monthly charge as part of the Option C and D bundles.14 11 a proposed rule change to amend the per bundle. According to the Exchanges, Users and Exchanges’ fee schedules related to co- potential customers requested that the location to add two Partial Cabinet designated May 6, 2021, as the date by which it Exchange offer Partial Cabinet Solution should approve, disapprove, or institute Solution bundles. The proposed rule bundles that include 40 Gb connections, changes were published for comment in proceedings to determine whether to disapprove the proposed rule changes. enabling them to connect to more of the the Federal Register on February 5, See Securities Exchange Act Release No. 91360 Included Data Products and Third Party 2021 or February 8, 2021, as (March 18, 2021), 86 FR 15764 (March 24, 2021) Data Feeds or have the same size 3 (SR–NYSEArca-2020–08). The Commission applicable. On March 18, 2021, connection in co-location that they have pursuant to Section 19(b)(2) of the Act,4 designated May 9, 2021, as the date by which it should approve, disapprove, or institute everywhere.15 the Commission designated a longer proceedings to determine whether to disapprove the The Exchanges propose to offer each period within which to either approve proposed rule change. new bundle for an initial charge of the proposed rule changes, disapprove 6 15 U.S.C. 78s(b)(2)(B). $10,000, and, following an initial the proposed rule changes, or institute 7 For purposes of the Exchanges’ co-location services, a ‘‘User’’ means any market participant promotional period, a charge of $18,000 proceedings to determine whether to per month for Option E, and $19,000 per 5 that requests to receive co-location services directly disapprove the proposed rule changes. from one or more of the Exchanges. month for Option F.16 In support of the 8 See Notice, supra note 3, at 8444. See Securities proposed fees, the Exchanges state that 1 15 U.S.C. 78s(b)(1). Exchange Act Release Nos. 77072 (February 5, the proposed $10,000 initial charge for 2 17 CFR 240.19b–4. 2016), 81 FR 7394 (February 11, 2016) (SR–NYSE– 3 See Securities Exchange Act Release Nos. 91034 2015–53); 77070 (February 5, 2016), 81 FR 7401 a new Option E or F bundle is (February 1, 2021), 86 FR 8443 (February 5, 2021) (February 11, 2016) (SR–NYSEArca-2015–102); reasonable because it is the same as that (SR–NYSE–2021–05); 91035 (February 1, 2021), 86 77072 (February 5, 2016), 81 FR 7382 (February 11, assessed for Users choosing the FR 8449 (February 5, 2021) (SR–NYSEAMER–2021– 2016) (SR–NYSEMKT–2015–89); 83351 (May 31, currently available Options C or D, and 04); 91036 (February 1, 2021), 86 FR 8440 (February 2018), 83 FR 26314, 26315 (June 6, 2018) (SR– 5, 2021) (SR–NYSECHX–2021–01); and 91037 NYSENAT–2018–07); 87408 (October 28, 2019), 84 (February 1, 2021), 86 FR 8424 (February 5, 2021) FR 58778, 58779–80 (November 1, 2019) (SR– 12 See Securities Exchange Act Release Nos. (SR–NYSENAT–2021–01); 91044 (February 2, NYSECHX–2019–12). 88837 (May 7, 2020), 85 FR 28671 (May 13, 2020) 2021), 86 FR 8662 (February 8, 2021) (SR– 9 Id. (SR–NYSE–2019–46, SR–NYSEAMER–2019–34, NYSEArca–2020–08) (each, a ‘‘Notice’’). For ease of 10 See id. at 8444. SR–NYSEArca–2019–61, SR–NYSENAT–2019–19) and 88972 (May 29, 2020), 85 FR 34472 (June 4, reference, page citations are to the Notice for 11 Id. In addition, Users must satisfy the following 2020) (SR–NYSECHX–2020–18). NYSE–2021–05. conditions to qualify for a Partial Cabinet Solution 13 4 15 U.S.C. 78s(b)(2). bundle: (1) A User and its Affiliates are limited to See Notice, supra note 3, at 8444. 5 See Securities Exchange Act Release Nos. 91357 one Partial Cabinet Solution bundle at a time, and 14 Id. (March 18, 2021), 86 FR 15732 (March 24, 2021) (2) after the purchase of the Partial Cabinet Solution 15 Id. The list of Included Data Products and (SR–NYSE–2021–05); 91358 (March 18, 2021), 86 bundle, the User, together with its Affiliates, must Third Party Data Feeds are set forth in the FR 15732 (March 24, 2021) (SR–NYSEAMER–2021– have an aggregate cabinet footprint of no more than Exchanges’ fee schedules. 04); 91362 (March 18, 2021), 86 FR 15765 (March 2 kW. See General Note 2 of the Price List. The 16 Users who order before December 31, 2021 24, 2021) (SR–NYSECHX–2021–01); and 91363 Exchanges also propose that General Note 2 apply would be charged $9,000 per month for Option E (March 18, 2021), 86 FR 15763 (March 24, 2021) to the Option E and F bundles, without alteration. or $9,500 per month for Option F for the first 12 (SR–NYSENAT–2021–01). The Commission Id. months of service.

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setting up each of the four options issues involved. Rather, the Commission demonstrate that the proposals, involves a similar amount of work for seeks and encourages interested persons including the proposed fees, are the Exchanges. The Exchanges also state to provide additional comment on the consistent with the Act. that proposed monthly charges of proposed rule changes to inform the Under the Commission’s Rules of $18,000 and $19,000 for Options E and Commission’s analysis of whether to Practice, the ‘‘burden to demonstrate F, respectively, each of which reflects a approve or disapprove the proposed that a proposed rule change is $4,000 increase over Options C and D, rule changes. consistent with the Exchange Act and respectively, are reasonable because the Pursuant to Section 19(b)(2)(B) of the the rules and regulations issued Exchanges will have to supply multiple Act,23 the Commission is providing thereunder . . . is on the self-regulatory 40 Gb connections to offer the proposed notice of the grounds for possible organization [‘SRO’] that proposed the new options.17 disapproval under consideration: rule change.’’ 27 The description of a The Exchanges state that the proposed • Whether the Exchanges have proposed rule change, its purpose and fees are equitably allocated and not demonstrated how the proposals are operation, its effect, and a legal analysis unfairly discriminatory, and will not consistent with Section 6(b)(4) of the of its consistency with applicable impose any burden on competition that Act, which requires that the rules of a requirements must all be sufficiently is not necessary or appropriate because national securities exchange ‘‘provide detailed and specific to support an they would apply to all Users equally, for the equitable allocation of reasonable affirmative Commission finding.28 Any the purchases would be completely dues, fees, and other charges among its failure of an SRO to provide this voluntary, and the Exchanges are members and issuers and other persons information may result in the subject to significant competitive using its facilities;’’ 24 Commission not having a sufficient forces.18 Regarding the competitive • Whether the Exchanges have basis to make an affirmative finding that environment, the Exchanges state that demonstrated how the proposals are a proposed rule change is consistent offering Options E and F to potential consistent with Section 6(b)(5) of the with the Act and the applicable rules Users would expand the range of Act, which requires, among other and regulations.29 options available, possibly making the things, that the rules of a national The Commission is instituting proposed bundles more attractive to securities exchange be ‘‘designed to proceedings to allow for additional potential Users who might otherwise perfect the operation of a free and open consideration and comment on the seek similar services from Hosting market and a national market system’’ issues raised herein, including as to Users.19 According to the Exchanges, and ‘‘protect investors and the public whether the proposals are consistent the proposal would enhance the interest,’’ and not be ‘‘designed to with the Act, specifically, with its competitive environment for potential permit unfair discrimination between requirements that the rules of a national Users while also allowing the Exchanges customers, issuers, brokers, or securities exchange provide for the to attempt to maintain a more level dealers;’’ 25 and equitable allocation of reasonable dues, • playing field with Hosting Users.20 The Whether the Exchanges have fees, and other charges among its Exchanges further state that the fees demonstrated how the proposals are members, issuers, and other persons charged for co-location services are consistent with Section 6(b)(8) of the using its facilities; are designed to constrained by the active competition Act, which requires that the rules of a perfect the operation of a free and open for the order flow and other business national securities exchange ‘‘not market and a national market system, from market participants who believe impose any burden on competition not and to protect investors and the public that co-location enhances the efficiency necessary or appropriate in furtherance interest; are not designed to permit of their operations.21 of the purposes of [the Act].’’ 26 unfair discrimination between As discussed in Section II above, the customers, issuers, brokers, or dealers; III. Proceedings To Determine Whether Exchanges make various arguments in and do not impose any burden on To Approve or Disapprove the support of the proposals, including that competition that is not necessary or Proposed Rule Changes the proposed initial charge and appropriate in furtherance of the The Commission is instituting proposed monthly charge of $18,000 for purposes of the Act; 30 as well as any proceedings pursuant to Section Option E and $19,000 for Option F are other provision of the Act, or the rules 19(b)(2)(B) of the Act to determine reasonable in relation to the fees and regulations thereunder. whether the Exchanges’ proposed rule charged for Options C and D, based on IV. Commission’s Solicitation of changes should be approved or the work entailed to provide the Comments disapproved.22 Institution of services and supply the 40 Gb proceedings does not indicate that the connections, and that the Exchanges are The Commission requests written Commission has reached any subject to significant competitive forces. views, data, and arguments with respect conclusions with respect to any of the The Commission believes that there are to the concerns identified above as well questions as to whether the Exchanges as any other relevant concerns. Such 17 Id. have provided sufficient information to comments should be submitted by June 18 See Notice, supra note 3, at 8446. 2, 2021. Rebuttal comments should be 19 Id. As the Exchanges acknowledge, a Hosting 23 Id. Section 19(b)(2)(B) of the Act also provides submitted by June 16, 2021. Although User is itself a co-location User, allowed by the that proceedings to determine whether to there do not appear to be any issues Exchanges to host other entities in the data center disapprove a proposed rule change must be for monthly fees charged by the Exchanges. See concluded within 180 days of the date of relevant to approval or disapproval that Notice, supra note 3, at 8445 and n. 10. The publication of notice of the filing of the proposed would be facilitated by an oral Exchanges state that they believe Hosting Users rule change. See id. The time for conclusion of the presentation of views, data, and offer similar services to those proposed, and that proceedings may be extended for up to 60 days if arguments, the Commission will because Hosting Users’ services are not regulated, the Commission finds good cause for such they may offer differentiated pricing and are not extension and publishes its reasons for so finding, consider, pursuant to Rule 19b–4, any required to make their pricing public. See Notice, or if the exchange consents to the longer period. See supra note 3, at 8445 and n. 11. id. 27 17 CFR 201.700(b)(3). 20 See Notice, supra note 3, at 8446. 24 15 U.S.C. 78f(b)(4). 28 See id. 21 See id. 25 15 U.S.C. 78f(b)(5). 29 See id. 22 15 U.S.C. 78s(b)(2)(B). 26 15 U.S.C. 78f(b)(8). 30 See 15 U.S.C. 78f(b)(4), (5), and (8).

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request for an opportunity to make an Washington, DC 20549, on official rulemaking regarding SBS dealers oral presentation.31 business days between the hours of (‘‘SBSDs’’) and major SBS participants The Commission asks that 10:00 a.m. and 3:00 p.m. Copies of such (‘‘MSBSPs’’) (collectively, ‘‘SBS commenters address the sufficiency and filing also will be available for Entities’’). merit of the Exchanges’ statements in inspection and copying at the principal The text of the proposed rule change support of the proposal, in addition to office of the Exchanges. All comments is available on FINRA’s website at any other comments they may wish to received will be posted without change. http://www.finra.org, at the principal submit about the proposed rule change. Persons submitting comments are office of FINRA and at the Interested persons are invited to cautioned that we do not redact or edit Commission’s Public Reference Room. submit written data, views, and personal identifying information from II. Self-Regulatory Organization’s arguments concerning the proposed rule comment submissions. You should Statement of the Purpose of, and changes, including whether the submit only information that you wish Statutory Basis for, the Proposed Rule proposed rule changes are consistent to make publicly available. All Change with the Act. Comments may be submissions should refer to File Nos. submitted by any of the following SR–NYSE–2021–05, SR–NYSEAMER– In its filing with the Commission, methods: 2021–04, SR–NYSEArca–2021–07, SR– FINRA included statements concerning NYSECHX–2021–01, and SR– the purpose of and basis for the Electronic Comments NYSENAT–2021–01and should be proposed rule change and discussed any • Use the Commission’s internet submitted on or before June 2, 2021. comments it received on the proposed comment form (http://www.sec.gov/ Rebuttal comments should be submitted rule change. The text of these statements rules/sro.shtml); or by June 16, 2021. may be examined at the places specified • in Item IV below. FINRA has prepared Send an email to rule-comments@ For the Commission, by the Division of sec.gov. Please include File Nos. SR– Trading and Markets, pursuant to delegated summaries, set forth in sections A, B, NYSE–2021–05, SR–NYSEAMER–2021– authority.32 and C below, of the most significant 04, SR–NYSEArca–2021–07, SR– J. Matthew DeLesDernier, aspects of such statements. NYSECHX–2021–01, and SR– Assistant Secretary. A. Self-Regulatory Organization’s NYSENAT–2021–01 on the subject line. [FR Doc. 2021–09971 Filed 5–11–21; 8:45 am] Statement of the Purpose of, and Paper Comments BILLING CODE 8011–01–P Statutory Basis for, the Proposed Rule Change • Send paper comments in triplicate 1. Purpose to Secretary, Securities and Exchange SECURITIES AND EXCHANGE Commission, 100 F Street NE, COMMISSION Background Washington, DC 20549–1090. [Release No. 34–91789; File No. SR–FINRA– On July 21, 2010, President Obama All submissions should refer to File 2021–008] signed into law the Dodd-Frank Wall Nos. SR–NYSE–2021–05, SR– Street Reform and Consumer Protection NYSEAMER–2021–04, SR–NYSEArca– Self-Regulatory Organizations; Act (the ‘‘Dodd-Frank Act’’).3 Title VII 2021–07, SR–NYSECHX–2021–01, and Financial Industry Regulatory of the Dodd-Frank Act, entitled the SR–NYSENAT–2021–01. The file Authority, Inc.; Notice of Filing of a ‘‘Wall Street Transparency and numbers should be included on the Proposed Rule Change Relating to Accountability Act of 2010,’’ 4 subject line if email is used. To help the Security-Based Swaps established a comprehensive new Commission process and review your regulatory framework for over-the- comments more efficiently, please use May 7, 2021. counter (‘‘OTC’’) derivatives known in only one method. The Commission will Pursuant to Section 19(b)(1) of the the industry as ‘‘swaps,’’ which were post all comments on the Commission’s Securities Exchange Act of 1934 generally unregulated in the United 1 2 internet website (http://www.sec.gov/ (‘‘Act’’) and Rule 19b–4 thereunder, States prior to passage of the Dodd- rules/sro.shtml). Copies of the notice is hereby given that on April 26, Frank Act. Among other things, Title VII submission, all subsequent 2021, the Financial Industry Regulatory of the Dodd-Frank Act was intended to amendments, all written statements Authority, Inc. (‘‘FINRA’’) filed with the implement in the United States the with respect to the proposed rule Securities and Exchange Commission mandate agreed by the G20 in change that are filed with the (‘‘SEC’’ or ‘‘Commission’’) the proposed September 2009 for its members to Commission, and all written rule change as described in Items I, II, improve the OTC derivatives markets by communications relating to the and III below, which Items have been improving transparency, mitigating proposed rule change between the prepared by FINRA. The Commission is systemic risk and protecting against Commission and any person, other than publishing this notice to solicit market abuse.5 those that may be withheld from the comments on the proposed rule change Generally, Title VII of the Dodd-Frank public in accordance with the from interested persons. Act divided regulatory jurisdiction over provisions of 5 U.S.C. 552, will be I. Self-Regulatory Organization’s swap products between the Commodity available for website viewing and Statement of the Terms of Substance of Futures Trading Commission (‘‘CFTC’’) printing in the Commission’s Public the Proposed Rule Change and the SEC, with the CFTC regulating Reference Room, 100 F Street NE, ‘‘swaps’’ and the SEC regulating SBS.6 FINRA is proposing to amend FINRA 31 15 U.S.C. 78s(b)(2). Section 19(b)(2) of the Act Rules 0180, 4120, 4210, 4220, 4240 and 3 Public Law 111–203, 124 Stat. 1376 (2010). grants the Commission flexibility to determine what 9610 to clarify the application of its 4 See Dodd-Frank Act Section 701. type of proceeding—either oral or notice and rules to security-based swaps (‘‘SBS’’) 5 See G20 Leaders’ Statement from The Pittsburgh opportunity for written comments—is appropriate following the SEC’s completion of its Summit (Sept. 24–25, 2009), https:// for consideration of a particular proposal by an www.treasury.gov/resource-center/international/g7- SRO. See Securities Acts Amendments of 1975, g20/Documents/pittsburgh_summit_leaders_ Report of the Senate Committee on Banking, 32 17 CFR 200.30–3(a)(57). statement_250909.pdf. Housing and Urban Affairs to Accompany S. 249, 1 15 U.S.C. 78s(b)(1). 6 The terms ‘‘swap’’ and ‘‘security-based swap’’ S. Rep. No. 75, 94th Cong., 1st Sess. 30 (1975). 2 17 CFR 240.19b–4. are defined in Sections 721 and 761 of the Dodd-

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The Dodd-Frank Act directed the SEC to Commission has also established the orders beginning in July 2011.12 With promulgate rulemakings implementing compliance date for registration of SBS limited exceptions, the SEC’s temporary the new regulatory framework for SBS, Entities, which will be October 6, 2021 exemptive orders relating to the including rules requiring SBS Entities to (the ‘‘Registration Compliance Date’’), regulation of SBS as securities have now register with the SEC; business conduct and has broadly coordinated the expired or will expire on the and supervision requirements, risk compliance date for a number of other Registration Compliance Date.13 mitigation techniques and other rules Title VII rulemakings with the The addition of SBS to the definition specifically applicable to SBS Entities; Registration Compliance Date.9 of ‘‘security’’ under the Act had similar recordkeeping and financial reporting Accordingly, beginning on October 6, implications for FINRA rules. In rules for SBS Entities; capital, margin 2021, registered SBS Entities will particular, under the amended and segregation requirements for SBS become subject to the Title VII definition, any FINRA rule that applies Entities; rules requiring regulatory rulemakings, and the deadline for the to FINRA members’ activities involving reporting and public dissemination of initial wave of SBS Entity registrations a security, securities business, a SBS information; and processes to is November 1, 2021.10 transaction involving a security or a require SBS to become subject to Title VII of the Dodd–Frank Act also securities position applies by its terms mandatory clearing and execution on a amended the definition of ‘‘security’’ to those activities involving SBS. registered or exempt execution facility under the Act to expressly encompass Therefore, consistent with the SEC’s or exchange.7 The Commission has now SBS.11 Therefore, in addition to the actions in this area, on July 8, 2011, finalized a majority of its rulemakings comprehensive new SBS-specific FINRA filed for immediate effectiveness pursuant to Title VII of the Dodd-Frank regulatory framework discussed above, FINRA Rule 0180, which, with certain Act (the ‘‘Title VII rulemakings’’).8 The SBS are now also defined as securities exceptions noted below, temporarily under the Act and the rules thereunder. limits the application of FINRA rules Frank Act. The Commission and the CFTC have This amendment to the Act was with respect to SBS, thereby avoiding jointly promulgated rules further defining these undue market disruptions resulting terms. See Securities Exchange Act Release No. effective as of July 16, 2011, the 67453 (July 18, 2012), 77 FR 48208 (August 13, effective date of Title VII of the Dodd- from the change to the definition of 2012) (Further Definition of ‘‘Swap,’’ ‘‘Security- Frank Act. However, to allow sufficient ‘‘security’’ under the Act.14 Pending the Based Swap,’’ and ‘‘Security-Based Swap time to consider the potentially complex SEC’s final implementation of the Title Agreement’’; Mixed Swaps; Security-Based Swap Agreement Recordkeeping) (‘‘Product Definitions’’). interpretive issues that may arise by 12 Very generally, SBS are swaps referencing a single defining SBS as securities, the SEC See, e.g., Securities Exchange Act Release No. security or loan, or a narrow-based security index. issued a series of temporary exemptive 64795 (July 1, 2011), 76 FR 39927 (July 7, 2011) Certain products sharing characteristics of both (Order Granting Temporary Exemptions Under the swaps and SBS are regulated as ‘‘mixed swaps’’ Securities Exchange Act of 1934 in Connection subject to both CFTC and SEC jurisdiction. fraud in the SBS market. See Securities Exchange With the Pending Revision of the Definition of Act Release No. 63236 (November 3, 2010), 75 FR 7 See Dodd-Frank Act Section 763. ‘‘Security’’ To Encompass Security-Based Swaps, 68560 (November 8, 2010) (Prohibition Against and Request for Comment) (‘‘2011 Exemptive 8 See Securities Exchange Act Release No. 74244 Fraud, Manipulation, and Deception in Connection Order’’); Securities Exchange Act Release No. 71485 (February 11, 2015), 80 FR 14564 (March 19, 2015) with Security-Based Swaps; Proposed Rule); (February 5, 2014), 79 FR 7731 (February 10, 2014) (Regulation SBSR—Reporting and Dissemination of Securities Exchange Act Release No. 63825 (Order Extending Temporary Exemptions Under the Security-Based Swap Information) (‘‘Regulation (February 2, 2011), 76 FR 10948 (February 28, 2011) Securities Exchange Act of 1934 in Connection SBSR Release’’); Securities Exchange Act Release (Registration and Regulation of Security-Based With the Revision of the Definition of ‘‘Security’’ No. 75611 (August 5, 2015), 80 FR 48964 (August Swap Execution Facilities; Proposed Rule; Proposed to Encompass Security-Based Swaps, and Request 14, 2015) (Final Rule: Registration Process for Interpretation). Security-Based Swap Dealers and Major Security- for Comment). 9 13 Based Swap Participants) (‘‘Registration Process See Cross-Border Release supra note 8, at 6345. See Securities Exchange Act Release No. 84991 Release’’); Securities Exchange Act Release No. The Commission stated that the Registration (January 25, 2019), 84 FR 863 (January 31, 2019) 77617 (April 14, 2016), 81 FR 29960 (May 13, 2016) Compliance Date for SBS Entities will be 18 months (Order Granting a Limited Exemption from the (Final Rule: Business Conduct Standards for after the effective date of the rules adopted pursuant Exchange Act Definition of ‘‘Penny Stock’’ for Security-Based Swap Dealers and Major Security- to the Cross-Border Release, which was April 6, Security-Based Swap Transactions between Eligible Based Swap Participants) (‘‘Business Conduct 2020. See Cross-Border Release at 6270. Generally, Contract Participants; Granting a Limited Standards Release’’); Securities Exchange Act the other Title VII rulemakings will apply to SBS Exemption from the Exchange Act Definition of Release No. 78011 (June 8, 2016), 81 FR 39808 (June Entities upon registration with the SEC. The first ‘‘Municipal Securities’’ for Security-Based Swaps; 17, 2016) (Final Rule: Trade Acknowledgment and compliance date for SBS reporting under Regulation and Extending Certain Temporary Exemptions Verification of Security-Based Swap Transactions) SBSR will be the first Monday that is the later of under the Exchange Act in Connection with the (‘‘Trade Acknowledgment and Verification (1) six months after the date on which the first SBS Revision of the Definition of ‘‘Security’’ to Release’’); Securities Exchange Act Release No. data repository (‘‘SBSDR’’) that can accept reports Encompass Security-Based Swaps) (‘‘2019 86175 (June 21, 2019), 84 FR 43872 (August 22, in a given asset class registers with the SEC and (2) Exemptive Order’’); Securities Exchange Act 2019) (Final Rule: Capital, Margin, and Segregation one month after the Registration Compliance Date. Release No. 90308 (November 2, 2020), 85 FR 70667 Requirements for Security-Based Swap Dealers and See Cross-Border Release at 6346. No SBSDRs are (November 5, 2020) (Order Granting Exemptions Major Security-Based Swap Participants and Capital currently registered with the SEC. from Sections 8 and 15(a)(1) of the Securities and Segregation Requirements for Broker-Dealers) 10 The Registration Compliance Date is October 6, Exchange Act of 1934 and Rules 3b–13(b)(2), 8c–1, (‘‘Capital, Margin, and Segregation Release’’); 2021. The SEC has also clarified that the 10b–10, 15a–1(c), 15a–1(d) and 15c2–1 Thereunder Securities Exchange Act Release No. 87005 transitional period before a person that is deemed in Connection with the Revision of the Definition (September 19, 2019), 84 FR 68550 (December 16, to be an SBSD must register with the SEC runs until of ‘‘Security’’ to Encompass Security-Based Swaps 2019) (Final Rule: Recordkeeping and Reporting two months after the end of the month in which the and Determining the Expiration Date for a Requirements for Security-Based Swap Dealers, person is no longer able to satisfy the de minimis Temporary Exemption from Section 29(b) of the Major Security-Based Swap Participants, and exception from the SBSD definition. Therefore, Securities Exchange Act of 1934 in Connection with Broker-Dealers) (‘‘Recordkeeping Release’’); entities exceeding the de minimis threshold on the Registration of Security-Based Swap Dealers and Securities Exchange Act Release No. 87780 first counting date of August 6, 2021 or later in Major Security-Based Swap Participants). (December 18, 2019), 85 FR 6270 (February 4, 2020) August 2021 must register no later than November Generally, the SEC has extended the expiration date (Final Rules; Guidance: Rule Amendments and 1, 2021. See SEC, Key Dates for Registration of for the temporary exemptions directly related to Guidance Addressing Cross-Border Application of Security-Based Swap Dealers and Major Security- pending SBS rulemakings until the compliance date Certain Security-Based Swap Requirements) Based Swap Participants, https://www.sec.gov/ for the related SBS rulemakings. Temporary (‘‘Cross-Border Release’’); Securities Exchange Act page/key-dates-registration-security-based-swap- exemptions not directly linked to SBS rulemakings Release No. 87782 (December 18, 2019), 85 FR 6359 dealers-and-major-security-based-swap-participants have either expired or, in certain limited (February 4, 2020) (Final Rule: Risk Mitigation (‘‘SEC Transitional Period Guidance’’). circumstances, been extended or made permanent. Techniques for Uncleared Security-Based Swaps) 11 See Dodd–Frank Act Section 761(a)(2) 14 See Securities Exchange Act Release No. 64884 (‘‘Risk Mitigation Release’’). The SEC has also (inserting ‘‘security–based swap’’ in the definition (July 14, 2011), 76 FR 42755 (July 19, 2011) (Notice proposed, but not yet finalized, rules governing SBS of ‘‘security’’ in Section 3(a)(10) of the Act); see also of Filing and Immediate Effectiveness of File No. execution facilities (‘‘SBSEFs’’) and rules regarding 15 U.S.C. 78c(a)(10). SR–FINRA–2011–033).

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VII rulemakings, FINRA has extended 4120, 4210, 4220, 4240 and 9610 to take discussed in greater detail below, the expiration date of FINRA Rule 0180 into account members’ SBS activities proposed FINRA Rules 0180(b) through a number of times, mostly recently in once SBS Entities begin registering with (g) would specify the exceptions from January 2020.15 FINRA Rule 0180 is the SEC on October 6, 2021. These this general presumption of currently set to expire on September 1, proposed amendments generally fall applicability that FINRA believes it 2021. into three categories. First, the proposed should provide to members engaged in FINRA Rule 0180 broadly excepts rule change would adopt a new FINRA SBS activity. Proposed FINRA Rule SBS activities from most FINRA Rule 0180, to replace expiring current 0180(i) also would provide FINRA with requirements. Specifically, FINRA Rule FINRA Rule 0180, that would generally exemptive authority to consider 0180(a) provides that FINRA rules shall apply FINRA rules to members’ exemptive relief from the application of not apply to members’ activities and activities and positions with respect to specific FINRA rules to SBS on a case- positions with respect to SBS, except for SBS, while providing limited exceptions by-case basis. FINRA Rule 2010 (Standards of for SBS in circumstances where FINRA As discussed above, Title VII of the Commercial Honor and Principles of believes such exceptions are Dodd-Frank Act amended the definition Trade), FINRA Rule 2020 (Use of appropriate. Second, the proposed rule of ‘‘security’’ under the Act to Manipulative, Deceptive or Other change would amend FINRA’s financial specifically encompass SBS.21 As the Fraudulent Devices), FINRA Rule 3310 responsibility and operational rules to Commission has noted, in ‘‘making this (Anti-Money Laundering Compliance conform to the SEC’s amendments to its change, Congress intended for [SBS] to Program) and FINRA Rule 4240 (Margin capital, margin and segregation be treated as securities under the Requirements for Credit Default requirements for SBSDs and broker- Exchange Act and the underlying rules Swaps).16 In addition, FINRA Rule dealers, and to otherwise take into and regulations.’’ 22 FINRA is a 0180(b) provides that the following account members’ SBS activities. registered national securities association rules apply to members’ activities and Finally, the proposed rule change would under Section 15A of the Act, which positions with respect to SBS only to adopt a new margin rule specifically requires, among other things, that the extent they would have applied as applicable to SBS, which would replace FINRA rules be designed to prevent of July 15, 2011 (i.e., the day before the the expiring interim pilot program fraudulent and manipulative acts and effective date of Title VII of the Dodd- establishing margin requirements for practices, to promote just and equitable Frank Act): (i) NASD Rule 3110 and all CDS. Each aspect of the proposed rule principles of trade, to foster cooperation successor FINRA Rules to such NASD change is discussed in greater detail and coordination with persons engaged Rule, (ii) the FINRA Rule 4500 Series below. in regulating, clearing, settling, and (iii) the FINRA Rule 4100 Series.17 processing information with respect to, General Presumption of Applicability Finally, FINRA Rule 0180(c) provides and facilitating transactions in that certain other rules apply as As described above, FINRA Rule 0180 securities, to remove impediments to necessary to effectuate members’ currently provides a broad, temporary and perfect the mechanism of a free and compliance with the rules applicable to exception from the application of open market and a national market SBS as noted above, including, for FINRA requirements to SBS by system, and, in general, to protect example, supervision requirements and providing that FINRA rules shall not investors and the public interest.23 rules relating to FINRA investigations apply to members’ activities and FINRA adopted existing Rule 0180 to and sanctions. positions with respect to SBS, with avoid undue market disruption while In light of the expiration of the SEC’s limited exceptions. Under the proposed the SEC completed its Title VII temporary exemptive orders, the rule change, current FINRA Rule 0180 rulemaking, but this broad exception finalization of the SEC’s regulatory would be replaced by a new FINRA was always intended to be temporary. framework for SBS, and the upcoming Rule 0180 on October 6, 2021, which Now that the SEC has largely finalized Registration Compliance Date, FINRA would effectively flip the existing its regulatory framework for SBS and set believes it is appropriate and in the presumption that FINRA rules do not the Registration Compliance Date for public interest for current FINRA Rule apply to SBS, with certain exceptions, SBS Entities, FINRA believes it would 0180 to expire and for FINRA to clarify and instead provide that, going forward, be consistent with Congress’s intent and the treatment of SBS under FINRA rules FINRA rules do apply to SBS, with FINRA’s regulatory responsibility to 18 19 going forward. Accordingly, FINRA is certain exceptions. Specifically, generally apply FINRA rules to proposing to amend FINRA Rules 0180, proposed FINRA Rule 0180(a) would members’ activities and positions with provide that, except as otherwise respect to SBS, subject to specified 15 See Securities Exchange Act Release No. 88023 provided in FINRA Rule 0180, FINRA (January 23, 2020), 85 FR 5261 (January 29, 2020) exceptions. rules shall apply to members’ activities Under proposed Rule 0180(a), FINRA (Notice of Filing and Immediate Effectiveness of 20 File No. SR–FINRA–2020–001). and positions with respect to SBS. As rules would generally apply to SBS in 16 FINRA Rule 4240 establishes an interim pilot the same manner that such rules apply program with respect to margin requirements for 19 Supplementary Material .01 to FINRA Rule to securities generally.24 FINRA notes any transactions in credit default swaps (‘‘CDS’’) 0180 provides that for purposes of FINRA Rule held in an account at a FINRA member. Like FINRA 0180, ‘‘security-based swap’’ has the same meaning that while the proposed rule change Rule 0180, the interim pilot program under FINRA as defined in Section 3(a)(68) of the Act and the would therefore regulate SBS activities Rule 4240 will automatically expire on September rules and guidance of the SEC or its staff. FINRA similarly to any other securities 1, 2021. See FINRA Rule 4240(a); see also Securities is not proposing to modify the definition of Exchange Act Release No. 89036 (June 10, 2020), 85 ‘‘security-based swap’’ in Supplementary Material FR 36458 (June 16, 2020) (Notice of Filing and .01. promote legal certainty and provide greater clarity for its members. Immediate Effectiveness of File No. SR–FINRA– 20 FINRA notes that since the definition of 21 2020–016). ‘‘security’’ now includes SBS, once current FINRA See supra note 11. 17 These FINRA rules relate to books and records Rule 0180 expires all FINRA rules applicable to 22 See 2011 Exemptive Order, supra note 12, at requirements and financial responsibility standards. securities will apply by their terms to SBS, 39929. 18 FINRA intends to extend the expiration dates regardless of whether a FINRA rule specifically 23 15 U.S.C. 78o–3(b)(6). of existing FINRA Rules 0180 and 4240 to October states that FINRA rules apply to SBS. However, 24 As for any other activity or product, members 6, 2021 to align with the Registration Compliance FINRA believes that including an affirmative are responsible for determining the regulatory Date and implementation of the proposed rule statement regarding the application of FINRA rules characterization of SBS and the applicability of change. to SBS in proposed FINRA Rule 0180(a) will specific rules to such products.

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activities of its members, it expects that that FINRA rules specific to activities First, Section 1 of Schedule A provides the practical impact of the proposed involving retail customers are unlikely for assessment of Member Regulatory rule change will be limited. As an initial to apply to SBS at this time. Fees, including the Trading Activity Fee matter, in developing the proposed rule FINRA notes that current FINRA Rule or ‘‘TAF.’’ The TAF applies only to sales change, FINRA solicited input from its 0180(a) provides: ‘‘The Rules shall not of ‘‘covered securities’’ as defined in members regarding their anticipated apply to members’ activities and paragraph (b) of Section 1 of Schedule SBS activities, including through direct positions with respect to security-based A. FINRA does not currently consider conversations with a number of swaps, except for’’ certain rules noted SBS to be ‘‘covered securities’’ as members that currently engage or have above. Article I of the FINRA By-Laws currently defined in paragraph (b), and affiliates that engage in SBS activity, an defines the ‘‘Rules’’ as used in FINRA therefore has not assessed the TAF with invitation for submission of views and Rule 0180(a) to mean ‘‘the numbered respect to SBS transactions entered into information on SBS activities on the rules set forth in the [FINRA manual] by its members. Second, Section 3 of FINRA website,25 and issuance of beginning with the Rule 0100 Series, as Schedule A provides that each member Regulatory Notice 20–36 soliciting adopted by the Board pursuant to these shall be assessed a Regulatory comment on a concept proposal relating By-Laws, as hereafter amended or Transaction Fee, which shall be to SBS.26 Based on feedback received, supplemented.’’ Current FINRA Rule determined periodically in accordance FINRA understands that only a small 0180 does not provide an exception with Section 31 of the Act.29 The SEC number of its members will register as from other parts of the FINRA manual, has addressed whether SBS are subject SBSDs or otherwise directly engage in including the FINRA By-Laws and to Section 31 fees, stating that SBS are SBS activities. In addition, FINRA notes related governance documents, the not currently subject to Section 31 fees that many of its rules relate to specific Capital Acquisition Broker (CAB) and will not become subject to Section activities or lines of business that are rulebook, the Funding Portal rulebook 31 fees until such time as the SEC unlikely to be relevant to SBS given the or the Temporary Dual FINRA–NYSE implements real-time public reporting unique and limited characteristics of Member Rules Series. Therefore, to the of SBS transactions.30 FINRA will SBS. For example, FINRA’s rules extent any of FINRA’s governance monitor developments with respect to relating to securities offerings and documents or other rule sets apply to the applicability of Section 31 fees to underwriting are unlikely to implicate securities activities, they already apply SBS and apply its Regulatory SBS.27 Moreover, at present SBS to SBS by their terms. However, FINRA Transaction Fee coextensively with generally may only be entered into with believes that these other parts of the Section 31 fees. Therefore, FINRA persons who qualify as ‘‘eligible FINRA manual likely have little direct expects that its Regulatory Transaction contract participants’’ (‘‘ECPs’’),28 such relevance to SBS activities, since they Fee will apply to SBS if real-time relate primarily to governance or, as is reporting for SBS comes into effect 25 See FINRA, Views and Information on Activity the case for the CAB and Funding Portal without the SEC providing an Related to Security-Based Swaps, https:// rulebooks, are likely generally exemption for SBS from Section 31 fees. www.finra.org/rules-guidance/requests-for- However, if the SEC grants an comments/security-based-swaps. inapplicable due to the restricted nature 26 See FINRA Regulatory Notice 20–36 (October of activities covered. FINRA also notes exemption from Section 31 for SBS, the 2020). that Schedule A to the FINRA By-laws Regulatory Transaction Fee would 27 FINRA notes that certain rules in the FINRA lists various fees that FINRA may assess, likewise not apply to SBS. Rule 5200 Series (Quotation and Trading including two types of transaction fees. FINRA believes that applying the Obligations and Practices) and 5300 Series general presumption of applicability of (Handling of Customer Orders) apply by their terms to ‘‘securities’’ generally, and therefore would apply execution on an exchange, and therefore all SBS at FINRA rules to SBS under proposed to SBS under the proposed rule change. FINRA present must be entered into with ECPs. believes such rules are likely to have limited impact FINRA’s retail customer-focused rules generally 29 See 15 U.S.C. 78ee. on SBS at present because SBS are generally apply to accounts of customers that do not meet the 30 Specifically, the SEC has stated: bilateral OTC derivatives transactions negotiated definition of an ‘‘institutional account’’ under A sale of a security is subject to Section 31 fees and entered into between two counterparties. FINRA Rule 4512(c). In addition to certain types of only if (1) the sale occurs on a national securities However, these trading and quoting rules may regulated entities, an ‘‘institutional account’’ under exchange, or (2) the sale is transacted by or through become more relevant to SBS in the future, FINRA Rule 4512(c) includes any person with total a member of a national securities association particularly if trading or execution of SBS on assets of at least $50 million. See FINRA Rule otherwise than on a national securities exchange exchanges or SBSEFs becomes prevalent. FINRA 4512(c)(3). Certain FINRA rules also exclude other and the security is registered on a national will monitor developments in the SBS market and specified types of entities or persons from the securities exchange or subject to prompt last-sale evaluate the appropriateness of applying these rules coverage of retail customer-focused provisions. See, reporting pursuant to the rules of the Commission to SBS transactions if quoting and trading activity e.g., FINRA Rule 2210(a)(4) (defining ‘‘institutional or a registered national securities association. develops. investor’’ for purposes of the communications with Although security-based swaps are securities, they 28 ‘‘Eligible contract participant’’ is defined under the public requirements as an institutional account do not meet any of the conditions noted above. the Act to have the same meaning as under the under FINRA Rule 4512(c) or certain other specified Thus, security-based swaps are currently not Commodity Exchange Act (‘‘CEA’’). See 15 U.S.C. entities, plans or persons). Given the differences subject to Section 31 fees and would not become 78c(a)(65). Under the CEA, ECPs are defined to between the ECP definition and the definition of subject to Section 31 fees due to the expiration of include certain regulated entities, such as broker- ‘‘institutional account’’ (or other variations used to the Unlinked Temporary Exemptions or the full dealers, futures commission merchants (‘‘FCMs’’), define non-retail customers in the FINRA rulebook), implementation of Regulation SBSR as it currently financial institutions and insurance companies, as it is possible that FINRA members may engage in exists. well as government entities and certain qualifying SBS with customers that qualify as ECPs but that The Dodd-Frank Act created a new Section 13(m) individuals and entities meeting net worth or total do not qualify as ‘‘institutional accounts,’’ and of the Exchange Act that requires ‘‘real-time public assets thresholds. See 7 U.S.C. 1a(18). Generally, an therefore would be covered by FINRA retail reporting’’ of security-based swap transactions. individual qualifying as an ECP must have amounts customer-focused rules. For example, an individual Once real-time public reporting is fully- invested on a discretionary basis in excess of may have more than $10 million invested on a implemented, security-based swaps will be subject $10,000,000, or $5,000,000 if hedging. See 7 U.S.C. discretionary basis, but not total assets of at least to prompt last-sale reporting pursuant to the rules 1a(18)(A)(xi). The Dodd-Frank Act amended the $50 million. Given the nature of the SBS market, of the Commission, which will subject them to Securities Act of 1933 (‘‘Securities Act’’) and the FINRA believes that this scenario is likely to occur Section 31 fees. Thus, when the Commission Act to require that SBS transactions involving a infrequently, but believes it would be appropriate proposes to implement prompt last-sale reporting person that is not an ECP must be registered under to apply FINRA rules applicable to activities for security-based swap transactions, it may also the Securities Act and effected on a national involving retail customers in such situations. revisit the appropriateness of exempting security- securities exchange. See Product Definitions, supra FINRA notes that its retail customer-focused rules based swaps from Section 31 fees at such time. note 6, at 48246 n.429. FINRA understands that no would also apply to SBS if non-ECP markets See 2019 Exemptive Order, supra note 13, at 866 SBS are currently registered or available for develop. (citations omitted).

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FINRA Rule 0180(a) as described above Securities), the OTC Bulletin Board issued’’ trading, ‘‘when, as and if is appropriate and in the public interest. Service (the OTCBB, an interdealer distributed’’ trading, marking to the In formulating the proposed rule quotation system for OTC Equity market, and close-out procedures. The change, however, FINRA reviewed its Securities), the Trade Reporting and UPC was created so that the transaction rulebook to evaluate whether it would Compliance Engine (TRACE, a facility of day-to-day business by members may be appropriate to provide exceptions for for reporting transactions in eligible be simplified and facilitated, that SBS from particular FINRA rules or rule debt securities), the Order Audit Trail business disputes and series and, if so, under what system (OATS, a system to capture misunderstandings, which arise from circumstances such exceptions should order information in NMS stocks and uncertainty and lack of uniformity in apply. Based on this review and OTC Equity Securities), compliance such matters, may be eliminated, and feedback from its members and others, with the Consolidated Audit Trail that the mechanisms of a free and open FINRA is proposing to provide three (CAT), and fees and charges associated market may be improved and categories of exceptions: (1) General with various FINRA facilities. Many of impediments thereto removed. For exceptions based on impracticability or these rules would clearly not apply to example, FINRA Rules 11310 through operational burdens; (2) limited SBS by their terms. For example, SBS 11365 address matters relating to the exceptions for SBS Entities and are not NMS stocks, nor are SBS subject delivery of securities, FINRA Rules associated persons of SBS Entities; and to the CAT. However, FINRA 11510 through 11581 address (3) limited exceptions in connection understands that the characterization of certificated security matters, FINRA with the conditions to the SEC’s cross- SBS may be unclear in some Rules 11610 through 11650 address the border SBS counting exception. In circumstances, which could raise the delivery of bonds and other evidence of addition, FINRA is proposing to provide possibility that certain of these rules indebtedness and FINRA Rules 11810 exemptive authority to exempt a person could be interpreted as applying to SBS. through 11894 address close-out from the application of specific FINRA FINRA does not intend for the FINRA procedures. rules to the person’s SBS activities in Rule 6000 or 7000 Series to apply to By its terms, the UPC applies to all circumstances not already covered by SBS, as these rules were specifically OTC secondary market transactions in the proposed rule change. Each of these designed for other types of securities securities between members, with 33 aspects of the proposed rule change is and would be operationally burdensome enumerated exceptions. Therefore, the discussed in greater detail below. if applied to SBS. In addition, reporting UPC could be interpreted as applying to to FINRA’s various trade reporting SBS transactions in some General Exceptions From Presumption circumstances. However, FINRA notes of Applicability facilities would be unnecessarily duplicative with the SEC’s Title VII that the UPC is limited to transactions Proposed FINRA Rule 0180(b) would rulemakings related to regulatory between members. It would therefore provide that the following FINRA rules reporting and public dissemination of apply only in the very limited shall not apply to members’ activities SBS information.31 Therefore, the circumstances involving SBS transacted and positions with respect to SBS: (1) proposed rule change would provide between FINRA members. As discussed The FINRA Rule 6000 Series; (2) the clarity in this area by specifically above, FINRA understands that only a FINRA Rule 7000 Series; and (3) the providing exceptions for SBS from the small number of its members will FINRA Rule 11000 Series. While some FINRA Rule 6000 and 7000 Series.32 register as SBSDs or otherwise directly of these rules could potentially be In addition, the FINRA Rule 11000 engage in SBS activities. The UPC interpreted as applying to SBS activities would therefore only potentially be Series sets forth the Uniform Practice by their terms, FINRA believes that invoked for a small portion of the SBS Code (‘‘UPC’’). The UPC is a series of these rules were intended for other market, which FINRA believes has the rules, interpretations and explanations types of securities and could create potential to create confusion and designed to make uniform, where operational difficulties if so applied. uncertainty. In addition, while FINRA practicable, custom, practice, usage, and Therefore, FINRA believes the proposed recognizes the importance of trading technique in the investment rule change would provide legal operational and settlement risks in SBS banking and securities business, certainty and clarity for its members by transactions, FINRA believes these risks particularly with regards to operational specifically excepting these rules from are more appropriately addressed and settlement issues. These can applying to members’ activities and through other means, including through positions with respect to SBS. include such matters as trade terms, the contractual provisions utilized by The FINRA Rule 6000 Series deliveries, payments, dividends, rights, SBS counterparties under industry- (Quotation, Order, and Transaction interest, reclamations, exchange of standard SBS documentation and, Reporting Facilities) and 7000 Series confirmations, stamp taxes, claims, where applicable, the SEC’s risk (Clearing, Transaction and Order Data assignments, powers of substitution, mitigation requirements.34 By contrast, Requirements, and Facility Charges) computation of interest and basis prices, include various rules relating to trading, due-bills, transfer fees, ‘‘when, as and if 33 See FINRA Rule 11100(a). Under FINRA Rule quoting, clearing and reporting for 11100(a)(1), transactions in securities between different types of securities. These rule 31 See Regulation SBSR Release, supra note 8. members which are compared, cleared or settled 32 FINRA notes that the FINRA Rule 6400 Series through the facilities of a registered clearing agency series includes rules relating to quoting (Quoting and Trading in OTC Equity Securities) are not subject to the UPC, except to the extent that and trading in NMS stocks, quoting and includes certain rules governing quoting and the rules of the clearing agency provide that rules trading in OTC Equity Securities, the trading practices for OTC Equity Securities. FINRA of other organizations shall apply. Paragraphs (a)(2) Alternative Display Facility (the ADF, a believes these rules are not relevant to SBS at through (a)(5) of FINRA Rule 11100 also provide present because SBS are generally OTC derivatives exceptions for specific types of securities, including facility for display of quotations in, and transactions negotiated and entered into between exempted securities, municipal securities, reporting OTC transactions in, NMS two counterparties. However, these type of trading redeemable securities issued by investment stocks), the Trade Reporting Facilities and quoting rules may become more relevant to SBS companies and Direct Participation Program (the TRFs, facilities for reporting OTC in the future, particularly if market centers begin Securities. quoting or trading SBS. FINRA will monitor 34 For example, the SEC’s SBS trading transactions in NMS stocks), the OTC developments in the SBS market and evaluate the relationship documentation rules require SBS Reporting Facility (the ORF, a facility appropriateness of applying these or similar rules Entities to have in place trading relationship for reporting transactions in OTC Equity to SBS transactions at such time. documentation including all terms governing the

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the UPC was designed to facilitate and business of the SBS Entity within the exceptions apply only where the SBS make uniform the operational aspects of meaning of the Exchange Act Rule activity is covered by the SEC’s rules cash securities transactions. These 15Fh–3(h)(1).36 As described below, and subject to the oversight and operational provisions were not each rule listed in proposed FINRA supervision of an SBS Entity (which designed for, and are not well-suited to, Rules 0180(c) and (d) is similar to a itself is subject to oversight by the the particular characteristics of SBS particular SEC rule or set of rules Commission and, if a FINRA member, transactions involving bilateral applicable to SBS Entities (or FINRA), proposed FINRA Rules 0180(c) contractual negotiations between specifically applicable to SBSDs, but not and (d) include a further condition that counterparties. FINRA therefore MSBSPs, in the case of proposed FINRA the SBS activities or positions relate to believes it is appropriate to except the Rule 0180(d)). FINRA believes it is the business of the SBS Entity within FINRA Rule 11000 Series from applying appropriate to provide exceptions from the meaning of the SEC’s SBS Entity to members’ activities and positions these specific FINRA rules, but only to supervision rule.39 with respect to SBS. the extent that the SEC’s parallel SBS Under proposed FINRA Rules 0180(c) and (d), these proposed exceptions Exceptions for SBS Entities and Entity rules will apply to the SBS 37 would be available for eight FINRA Associated Persons activity. The exceptions are therefore limited to circumstances where the rules, subject to the conditions As discussed above, the SEC has now member engaged in the SBS activity is described above. Specifically, proposed completed the majority of its Title VII acting in its capacity as an SBS Entity, FINRA Rule 0180(c) would provide rulemakings, including business or where the associated person engaged exceptions for the following FINRA conduct standards, trade rules: in the SBS activity is acting in his or her • acknowledgement and verification capacity as an associated person of an FINRA Rule 2210(d) requirements, risk mitigation techniques SBS Entity.38 To ensure that the (Communications with the Public— and recordkeeping rules for SBS Content Standards) requires members to 35 Entities. These rules will apply to SBS 36 See 17 CFR 240.15Fh–3(h)(1). These exceptions adhere to content standards with respect Entities once they register with the SEC are split between paragraphs (c) and (d) of proposed to all of their communications, whether on or after the Registration Compliance FINRA Rule 0180 to account for certain SEC rules correspondence, retail communications Date. As described below, certain of that apply only to SBSDs, but not MSBSPs. or institutional communications. Specifically, the exceptions in proposed FINRA these new SBS-specific rules are similar Rule 0180(c) would apply for all Swap Entities, Among other things, FINRA Rule to existing FINRA rules that apply to while the exceptions in proposed FINRA Rule 2210(d) requires that member members’ securities activities generally. 0180(d) would apply only for SBSDs. communications be based on principles FINRA believes that applying both the 37 Conversely, the proposed exceptions would not SEC’s rules for SBS Entities and apply in circumstances where the SEC’s SBS Entity as an associated person of an affiliated SBS Entity rules do not apply. For example, the exceptions in FINRA’s parallel rules for its members under the dual-hatted structure described above. proposed FINRA Rules 0180(c) and (d) would not FINRA is providing this guidance to promote legal to the same SBS activity would result in apply to a member engaged in SBS brokerage certainty and provide clarity to its members unnecessary regulatory duplication. activity. FINRA notes that the SEC has regarding the application of the particular rules Therefore, to promote regulatory clarity contemplated that a registered broker-dealer covered by the proposed exceptions in FINRA Rule and avoid unnecessary regulatory engaged in SBS brokerage activity would be subject 0180(c). The proposed rule change does not address to applicable self-regulatory organization rules. See, whether or to what extent other FINRA rules not duplication, the proposed rule change e.g., Cross-Border Release at 6284, Business covered by proposed FINRA Rule 0180(c) might would provide exceptions from specific Conduct Standards Release at 29966–68, supra note apply to a dual-hatted associated person when he FINRA rules in circumstances where the 8. The exceptions would also not apply to a or she is acting in his or her capacity as an member entering into SBS below the de minimis associated person of an affiliated SBS Entity. SEC’s SBS Entity rules will apply to the threshold for SBSD registration or engaging in other SBS activity. As described in further FINRA also notes that whether a particular SBS activity not requiring SBS Entity registration individual is acting as an associated person of the detail below, proposed FINRA Rules (e.g., SBS hedging activity). In these circumstances, member or of an SBS Entity (whether the same 0180(c), (d), (f) and (g) would specify the FINRA rules would apply to the SBS activity. entity as the member or an affiliated entity) is a the FINRA rules subject to these 38 FINRA’s business conduct rules apply both to facts and circumstances determination and is not the FINRA member and persons associated with the exceptions and the conditions to such dependent on the particular method in which such member. Similarly, the SEC’s SBS Entity rules arrangements are documented. However, FINRA exceptions. apply to activity undertaken by an SBS Entity or its reminds members that they must be able to Proposed FINRA Rules 0180(c) and associated persons. Therefore, proposed Rule demonstrate how a particular individual is (d) would provide that certain specified 0180(c) applies to the SBS activities engaged in by designated and for what purposes, as well as the FINRA rules shall not apply to a member that is also registered as an SBS Entity specific capacity in which an individual is acting as well as SBS activities engaged in by an with respect to any particular transaction or members’ activities and positions with associated person of a member where the associated activity. respect to SBS, to the extent that the person is acting in their capacity as an associated 39 The SEC’s SBS supervision rule states: ‘‘A member is acting in its capacity as an person of an SBS Entity, since the SBS Entity rules security-based swap dealer or major security-based SBS Entity or the associated person of would apply in those circumstances. The swap participant shall establish and maintain a exceptions would therefore apply to an associated system to supervise, and shall diligently supervise, the member is acting in his or her person of a member that is also registered as an SBS its business and the activities of its associated capacity as an associated person of an Entity where the associated person is acting in his persons. Such a system shall be reasonably SBS Entity, as applicable, and that such or her capacity as an associated person of the SBS designed to prevent violations of the provisions of activities or positions relate to the Entity. applicable federal securities laws and the rules and FINRA understands that certain firms engaged in regulations thereunder relating to its business as a SBS activity may employ a ‘‘dual-hatted’’ personnel security-based swap dealer or major security-based trading relationship between the SBS Entity and its structure. In this structure, an affiliate of the swap participant, respectively.’’ 17 CFR 240.15Fh– counterparty, including, without limitation, terms member is registered as an SBS Entity, but the 3(h)(1). Therefore, to qualify for the exceptions in addressing payment obligations, netting of member itself is not dually-registered as an SBS proposed FINRA Rules 0180(c) and (d), the payments, events of default or other termination Entity. However, certain personnel of the member particular SBS activity must be within the scope of events, calculation and netting of obligations upon may be ‘‘dual-hatted’’ such that they act as the business of the SBS Entity that is subject to the termination, transfer of rights and obligations, associated persons of the member with respect to SBS Entity’s supervisory system. If an SBS Entity governing law, valuation, and dispute resolution. general securities activities but as associated were to engage in other SBS activity that it did not See 17 CFR 240.15Fi–5(b)(1). persons of the affiliated SBS Entity with respect to consider within the scope of its business as an SBS 35 See Business Conduct Standards Release; Trade the SBS Entity’s SBS activities. FINRA intends for Entity, and therefore not subject to the SEC’s rules Acknowledgment and Verification Release; Risk the exceptions in proposed FINRA Rule 0180(c) to applicable to SBS Entities, the exceptions would Mitigation Release; Recordkeeping Release, supra apply to SBS activities undertaken by an associated not be available and the applicable FINRA rules note 8. person of a member acting in his or her capacity would apply to that activity.

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of fair dealing and good faith, be fair certifications to FINRA related to the designed to obtain and retain a record and balanced, and not omit any material member’s compliance policies and of the essential facts concerning each facts or make false or exaggerated written supervisory procedures. The counterparty whose identify is known to claims. The SEC’s business conduct SEC’s business conduct rules for SBS the SBSD that are necessary for rules for SBS Entities include Exchange Entities include Exchange Act Rules conducting business with such Act Rule 15Fh–3(g), which generally 15Fh–3(h) and 15Fk–1.45 Exchange Act counterparty. requires SBS Entities to communicate Rule 15h–3(h) requires, among other • FINRA Rule 2111 (Suitability) is with counterparties in a fair and things, an SBS Entity to establish and FINRA’s suitability rule, which balanced manner based on principles of maintain a system to supervise, and to generally requires a member or fair dealing and good faith.40 The SEC’s diligently supervise, its business and associated person to have a reasonable business conduct rules also include the activities of its associated persons; basis that a recommended transaction or requirements for SBS Entities to make designation of at least one person with investment strategy is suitable for the certain disclosures to their SBS authority to carry out supervisory customer.49 The SEC’s business conduct counterparties, including disclosures of responsibilities; and establishment, rules for SBS Entities include Exchange material risks and characteristics of the maintenance and enforcement of written Act Rules 15Fh–3(f) and 15Fh–5.50 SBS and material incentives or conflicts policies and procedures addressing Exchange Act Rule 15Fh–3(f) imposes of interest (Exchange Act Rule 15Fh– supervision of the SBS Entity’s SBS similar suitability obligations on SBSDs 3(b)), daily mark disclosures (Exchange business. Exchange Act Rule 15Fk–1 (but not MSBSPs) with respect to Act Rule 15Fh–3(c)) and disclosures requires each SBS Entity to designate a recommendations of SBS or trading regarding clearing rights (Exchange Act chief compliance officer and submit strategies.51 In addition, Exchange Act Rule 15Fh–3(d)).41 annual compliance reports to the SEC. • FINRA Rule 2232 (Customer Proposed FINRA Rule 0180(d) would 49 Specifically, FINRA Rule 2111 is composed of Confirmations) generally requires provide exceptions for the following three main obligations: reasonable-basis suitability, members to provide customers with FINRA Rules: customer-specific suitability, and quantitative • suitability. The reasonable-basis obligation requires written confirmations in conformity FINRA Rule 2030 (Engaging in a member or associated person to have a reasonable with Exchange Act Rule 10b–10,42 along Distribution and Solicitation Activities basis to believe, based on reasonable diligence, that with specified additional disclosures for with Government Entities) is FINRA’s the recommendation is suitable for at least some ‘‘pay-to-play’’ rule, which imposes investors. A member’s or associated person’s certain types of securities. Exchange Act reasonable diligence must provide the member or Rule 15Fi–2 requires SBS Entities to restrictions on member firms engaging associated person with an understanding of the provide trade acknowledgements and to in distribution or solicitation activities potential risks and rewards associated with the establish, maintain and enforce written with government entities. Exchange Act recommended security or strategy. The customer- Rule 15Fh–6 imposes pay-to-play specific obligation requires that a member or policies and procedures reasonably associated person have a reasonable basis to believe designed to obtain prompt verification restrictions on SBSDs (but not MSBSPs), that the recommendation is suitable for a particular of the terms of such trade including similar restrictions on an customer based on that customer’s investment acknowledgments.43 FINRA also notes SBSD engaging in SBS transactions with profile, with the ability to fulfill this obligation for that the SEC’s trade acknowledgement a municipal entity within two years an institutional account if (i) the member or associated person has a reasonable basis to believe and verification rule provides that an after specified types of political that the institutional customer is capable of SBS Entity that is also a broker or contributions have been made to evaluating investment risks independently, both in dealer, is purchasing from or selling to officials of the municipal entity.46 general and with regard to particular transactions any counterparty, and that complies • FINRA Rule 2090 (Know Your and investment strategies involving a security or Customer) generally requires that each securities, and (ii) the institutional customer with the relevant requirements of the affirmatively indicates that it is exercising trade acknowledgement and verification member use reasonable diligence to independent judgment in evaluating the member’s rule, is exempt from the requirements of know and retain essential facts or associated person’s recommendations. Exchange Act Rule 10b–10 with respect concerning every customer and the Quantitative suitability requires a member or to the SBS transaction.44 authority of each person acting on associated person to have a reasonable basis for • believing that a series of recommended FINRA Rules 3110 (Supervision), behalf of such customer. The SEC’s transactions, even if suitable when viewed in 3120 (Supervisory Control System) and business conduct rules for SBS Entities isolation, are not excessive and unsuitable for the 3130 (Annual Certification of include Exchange Act Rules 15Fh–3(a) customer when taken together in light of the Compliance and Supervisory Processes) and (e).47 Exchange Act Rule 15Fh–3(a) customer’s investment profile. See Supplementary Material .05 to FINRA Rule 2111. require, among other things, each generally requires SBS Entities to verify 50 See 17 CFR 240.Fh–3(f) and Fh–5; Business member to establish and maintain a the status of their SBS counterparties, Conduct Standards Release, supra note 8, at 29994– supervisory system; establish, maintain including verification that the 30000 and 30007–45. and enforce written supervisory counterparty is an ECP and whether the 51 Specifically, Exchange Act Rule 15Fh–3(f)(1)(i) procedures; designate principals to counterparty is a ‘‘special entity.’’ 48 provides that an SBSD that recommends an SBS or trading strategy involving an SBS to a counterparty establish, maintain and enforce a system Exchange Act Rule 15Fh–3(e) requires (other than an SBS Entity, swap dealer or major of supervisory control policies and each SBSD (but not MSBSP) to swap participant) must undertake reasonable procedures; designate a chief establish, maintain and enforce written diligence to understand the potential risks and compliance officer; and submit annual policies and procedures reasonably rewards associated with the recommended SBS or trading strategy involving an SBS. FINRA notes that, as proposed, Exchange Act Rule 15Fh–3(f)(1)(i) 45 40 See 17 CFR 240.15Fh–3(g); Business Conduct See 17 CFR 240.15Fh–3(h) and 15Fk–1; would have required an SBSD to have a reasonable Standards Release, supra note 8, at 30000–02. Business Conduct Standards Release, supra note 8, basis to believe, based on reasonable diligence, that 41 See 17 CFR 240.15Fh–3(b), (c) and (d); Business at 30002–07 and 30050–61. the recommended SBS or trading strategy is suitable Conduct Standards Release, supra note 8, at 29980– 46 See 17 CFR 240.15Fh–6; Business Conduct for at least some counterparties (similar to FINRA 93. Standards Release, supra note 8, at 30045–50. Rule 2111’s reasonable-basis obligation). See 42 See 17 CFR 240.10b–10. 47 See 17 CFR 240.15Fh–3(a) and (e); Business Business Conduct Standards Release, supra note 8 43 See 17 CFR 240.15Fi–2; see generally Trade Conduct Standards Release, supra note 8, at 29978– at 29994. When adopting its final business conduct Acknowledgment and Verification Release, supra 80 and 29993–94. rules, the SEC modified Exchange Act Rule 15Fh– note 8. 48 ‘‘Special entity’’ is defined in Exchange Act 3(f)(1)(i) to ‘‘rephrase the suitability obligation . . . 44 See 17 CFR 240.15Fi–2(g); Trade Rule 15Fh–2(d) and includes certain government to make it consistent with the CFTC’s parallel Acknowledgement and Verification Release, supra entities, employee benefit plans and endowments. suitability requirement in Commodity Exchange Act note 8, at 39824–25. See 17 CFR 240.15Fh–2(d). Rule 23.434(a)(1), which explicitly requires [SBSDs]

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Rule 15Fh–5 applies special, enhanced member to maintain specified during the calendar quarter) to once requirements when SBS Entities act as information for each customer account, annually (for SBS portfolios that include counterparties to special entities. including specified identifying no more than 100 SBS at any time Proposed FINRA Rule 0180(f) would information about the customer. during the calendar year).54 provide that FINRA Rules 2231 FINRA believes that the customer FINRA acknowledges that the SEC’s (Customer Account Statements) and account statements required under SBS portfolio reconciliation rule differs 4512 (Customer Account Information) FINRA Rule 2231 generally should in some respects from the customer shall not apply to members’ activities reflect a holistic view of a member’s account statement requirements under and positions with respect to SBS, to the relationship with its customer, FINRA Rule 2231. For example, the extent that the member is acting in its including SBS transactions, positions frequency of portfolio reconciliations capacity as an SBS Entity and the and related collateral, if applicable. varies as described above, while customer’s account solely holds SBS Therefore, to the extent that a customer account statements must be and collateral posted as margin in customer’s account includes SBS along delivered at least quarterly. In addition, connection with such SBS, provided with other securities positions or as described above, an SBS entity must that the member complies with the activity, or related money balances, then have policies and procedures in place to portfolio reconciliation requirements of FINRA believes that the account ensure that it engages in portfolio Exchange Act Rule 15Fi–3 with respect statement under FINRA Rule 2231 reconciliation with non-SBS Entity to such account and that such portfolio should include SBS. However, FINRA counterparties, while a member must reconciliations include collateral posted understands that members that are also provide a customer account statement to as margin in connection with SBS in the registered SBS Entities may have each customer unless a specific account. FINRA Rule 2231 generally customer accounts that hold solely SBS exception under FINRA Rule 2231(b) requires each member to provide, on at and related collateral, and do not hold applies. However, FINRA believes that, least a quarterly basis, an account any other securities positions or have while not identical, Exchange Act Rule statement to each customer containing a any other securities activity. While SBS 15Fi–3 serves similar purposes to description of any securities positions, Entities are not subject to a customer FINRA Rule 2231, such that requiring money balances or account activity account statement requirement with members that are SBS Entities to also during the period since the last respect to SBS, the SEC’s risk mitigation provide customer account statements for customer account statement. FINRA requirements for SBS Entities include accounts holding solely SBS and related Rule 4512 generally requires each Exchange Act Rule 15Fi–3, which collateral would be unnecessarily requires SBS Entities to engage in duplicative. Accordingly, to promote to understand the risk-reward tradeoff of their portfolio reconciliation with their regulatory clarity and avoid unnecessary recommendations.’’ In doing so, the SEC noted that counterparties.52 Exchange Act Rule duplication, proposed FINRA Rule the SEC’s ‘‘proposed formulation and the CFTC’s formulation would have achieved the same 15Fi–3(a) generally requires SBS 0180(f) would provide an exception purpose.’’ See id. at 29996. The SEC also noted that Entities to engage in portfolio from FINRA Rule 2231 in the limited the ‘‘new formulation is also consistent with reconciliation for all SBS with their SBS circumstances where the member is FINRA’s approach to this aspect of suitability [i.e., Entity counterparties, with the acting in its capacity as an SBS Entity the reasonable-basis obligation as described in Supplementary Material .05(a) to FINRA Rule frequency of such portfolio and the account solely holds SBS and 2111].’’ See id. at 29996 n.493. As with the reconciliations ranging from once each collateral posted as margin in reasonable-basis obligation in FINRA Rule 2111, business day (for SBS portfolios that connection with such SBS. FINRA notes SBSDs ‘‘are always required to meet their suitability include 500 or more SBS), to once each that collateral in a customer’s account obligation in [Exchange Act] Rule 15Fh–3(f)(1)(i), regardless of whether they avail themselves of the week (for SBS portfolios that include would be included in account institutional suitability alternative to meet their more than 50 but fewer than 500 SBS on statements provided under FINRA Rule customer-specific obligations.’’ See id. at 29997. any business day during the week), to 2231. The proposed rule change In addition, Exchange Act Rule 15Fh–3(f)(1)(ii) once each calendar quarter (for SBS therefore includes as a condition to the requires the SBSD to have a reasonable basis to proposed exception that the member believe that a recommended SBS or trading strategy portfolios that include no more than 50 involving an SBS is suitable for the counterparty SBS at any time during the calendar comply with Exchange Act Rule 15Fi– (similar to FINRA Rule 2111’s customer-specific quarter).53 Exchange Act Rule 15Fi–3(b) 3 with respect to an account qualifying obligation). Also similar to the institutional account requires each SBS Entity to establish, for the exception and include collateral alternative in FINRA Rule 2111, an SBSD may in the portfolio reconciliation and fulfill its obligations under Exchange Act Rule maintain, and follow written policies 15Fh–3(f)(1)(ii) with respect to an institutional and procedures reasonably designed to dispute resolutions requirements as counterparty if it complies with specified ensure that it engages in portfolio applied to such an account. conditions, including reasonably determining that reconciliation for all SBS with non-SBS The SEC’s risk mitigation the counterparty or its agent is capable of requirements for SBS also include independently evaluating investment risks with Entity counterparties, with the regard to the relevant SBS or trading strategy frequency of such portfolio Exchange Act Rule 15Fi–5, which involving an SBS and that the counterparty or its reconciliations ranging from once each requires SBS Entities to have in place agent affirmatively represents in writing that it is calendar quarter (for SBS portfolios that SBS trading relationship documentation exercising independent judgment in evaluating the include more than 100 SBS at any time with their SBS counterparties, including recommendations of the SBSD with regard to the all terms governing the trading relevant SBS or trading strategy involving an SBS. See Exchange Act Rules 15Fh–3(f)(2) and (3). 52 See 17 CFR 240.15Fi–3; Risk Mitigation relationship between the SBS and its FINRA acknowledges that the SEC’s suitability Release, supra note 8, at 6362–70. For purposes of counterparty.55 In addition, SBS Entities rule differs in some respects from FINRA’s Exchange Act Rule 15Fi–3, ‘‘portfolio that are also registered broker-dealers suitability requirements under FINRA Rule 2111. reconciliation’’ is defined as any process by which are subject to the SEC’s recordkeeping For example, Exchange Act Rule 15F–3(f) does not counterparties to one or more SBS (1) exchange the explicitly include a quantitative suitability material terms of all SBS in the SBS portfolio requirements under Exchange Act Rule obligation. However, FINRA believes that, while not between the counterparties, (2) exchange each identical, Exchange Act Rule 15Fh–3(f) serves counterparty’s valuation of each SBS in the SBS 54 See 17 CFR 240.15Fi–3(b). similar purposes to FINRA Rule 2111, such that portfolio between the counterparties as of the close 55 See 17 CFR 240.15Fi–5; Risk Mitigation requiring members that are SBSDs to also comply of business on the immediately preceding day and Release, supra note 8, at 6372–6377. SEC rules also with FINRA Rule 2111 in circumstances where (3) resolve any discrepancy in valuations or require SBS Entities to maintain records of SBS Exchange Act Rule 15Fh–3(f) applies would be material terms. See 17 CFR 240.15Fi–1(l). trading relationship documentation. See 17 CFR unnecessarily duplicative. 53 See 17 CFR 240.15Fi–3(a). 17a–4(e)(12)(ii).

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17a–3, which require, among other believes that associated persons of a registered SBS Entities.58 FINRA also things, certain records to be kept for member who are engaged in SBS notes that, although individuals each SBS account.56 These SEC rules activities generally should be qualifying for the proposed exception generally require SBS Entities to obtain registered—and subject to would not be required to register with and keep records of certain information accompanying licensing and CE FINRA (and therefore a member firm in connection with their SBS accounts, requirements—as appropriate based on would not be required to file a Form U4 including SBS-specific identifying the scope of their activities (e.g., Series on behalf of such individuals), they information. FINRA believes that, while 7 for general SBS activities, Series 24 for would remain associated persons of the not identical to FINRA Rule 4512, these SBS principals, etc.). However, FINRA member subject to all FINRA and SEC SEC rules serve similar purposes, and understands that members that are also rules applicable to such associated that also applying FINRA Rule 4512 to registered SBS Entities may in some persons, including fingerprinting SBS-only accounts would be limited circumstances have an requirements under Exchange Act Rule duplicative. Accordingly, in order to 17f–2.59 associated person whose securities- promote regulatory clarity and avoid related activities relate solely and Exceptions in Connection With the unnecessary duplication, FINRA SEC’s Cross-Border Exception believes it is appropriate to provide an exclusively to transactions conducted in exception from FINRA Rule 4512 in the the individual’s capacity as an In connection with finalizing the Title limited circumstances where the associated person of the SBS Entity. VII rulemakings, the SEC also adopted member is acting in its capacity as an Such individuals engage solely in SBS a number of rules and provided SBS Entity and the account solely holds activities on behalf of the SBS Entity guidance to address the cross-border SBS and collateral posted as margin in (and potentially non-securities application of various SBS connection with such SBS. Both activities, such as swaps), but do not requirements. One of these rules, exceptions under proposed FINRA Rule engage in any other securities activities Exchange Act Rule 3a71–3(d), provides 0180(f) would not apply to accounts that would require registration under a conditional exception to the holding SBS together with other FINRA Rule 1210. provisions of Exchange Act Rule 3a71– securities or to members that are not FINRA’s current registration, 3 that otherwise would require non-U.S. persons to count—against the thresholds also registered SBS Entities. licensing and CE requirements are not associated with the de minimis Finally, proposed FINRA Rule 0180(g) specifically tailored to SBS. To reduce exception to the SBSD definition—SBS would provide that persons associated unnecessary regulatory burdens, FINRA with a member whose functions are dealing transactions with non-U.S. therefore believes it is appropriate for related solely and exclusively to SBS counterparties when U.S. personnel the proposed rule change to provide an undertaken in such person’s capacity as arrange, negotiate or execute those an associated person of an SBS Entity exception at the current time from these transactions.60 To qualify for this are not required to be registered with requirements in the limited exception, all such arranging, FINRA.57 Generally, FINRA Rule 1210 circumstances where an associated negotiating or executing activity must be requires that each person engaged in the person of a member is engaged solely conducted by U.S. personnel in their investment banking or securities and exclusively in SBS activities in his capacity as persons associated with a business of a member must be registered or her capacity as an associated person registered broker-dealer or a registered with FINRA as a representative or of an SBS Entity. Under this proposed SBSD that is a majority-owned affiliate principal in each category of registration exception, such persons would not be of the non-U.S. person relying on the appropriate to his or her functions and required to register with FINRA, and exception (the ‘‘U.S. Registered responsibilities as specified in FINRA therefore would not be required to pass Affiliate’’).61 Further, to qualify for the Rule 1220. Individuals seeking to any qualification examinations or exception, the U.S. Registered Affiliate become registered with FINRA generally become subject to CE requirements must comply with specified SBS Entity must pass an appropriate qualification under FINRA Rule 1240. This proposed rules with respect to such SBS examination, and registered individuals exception is based on FINRA’s analysis transactions as if the counterparties to are subject to continuing education of its existing registration and related the non-U.S. person relying on the (‘‘CE’’) requirements under FINRA Rule requirements, and its understanding exception also were counterparties to 1240. These registration, licensing and that the number of such associated the U.S. Registered Affiliate and as if the CE requirements would generally apply persons is limited. FINRA will monitor U.S. Registered Affiliate were registered 62 to associated persons of a member developments with respect to the SBS as an SBSD, if not so registered. The engaged in SBS activities due to the activities of its members and will change to the definition of ‘‘security’’ to 58 FINRA notes that associated persons of SBS continue to consider whether it would Entities are not independently subject to encompass SBS. Accordingly, FINRA be appropriate to tailor the registration registration, licensing or CE requirements. However, and related requirements to SBS, for an SBS Entity is prohibited from permitting an 56 See 17 CFR 240.17a–3; see generally associated person that is subject to a statutory Recordkeeping Release, supra note 8. FINRA notes example through targeted SBS-related disqualification to effect or be involved in effecting in particular Exchange Act Rule 17a–3(a)(9)(iv), registration categories or the addition of SBS on behalf of the SBS Entity. See 15 U.S.C. 78o– which requires an SBS Entity to keep a record, for SBS-specific content to qualification 10(b)(6). The SEC’s SBS Entity registration rules each SBS account, of the unique identification code examinations or CE content. FINRA will also require an SBS Entity to certify that it neither of the counterparty, the name and address of the knows, nor in the exercise of reasonable care should counterparty, and a record of the authorization of consider whether it would be have known, of any such statutory disqualification. each person the counterparty has granted authority appropriate to rescind the exception Such certifications must be supported by to transact business in the SBS account. See 17 CFR under proposed FINRA Rule 0180(g) in questionnaires or employment applications serving as the basis for background checks. See 17 CFR 240.17a–3(a)(9)(iv). such circumstances. The exception 57 This exception is structured similarly to 240.15Fb6–2; Registration Process Release, supra existing exceptions from registration for persons under proposed FINRA Rule 0180(g) note 8, at 48973–79. associated with a member whose functions are would not apply to associated persons 59 See 17 CFR 240.17F–2. related solely and exclusively to certain other of a member engaged in any other 60 See 17 CFR 240.3a71–3(d); Cross-Border Release, supra note 8, at 6276–92. product types (such as municipal securities, securities activities or to associated commodities or security futures), as found in 61 See 17 CFR 240.3a71–3(d)(1)(i). FINRA Rule 1230. persons of members that are not also 62 See 17 CFR 240.3a71–3(d)(1)(ii)(A).

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specified SBS Entity rules under this of its rules are appropriate. FINRA Financial Responsibility and exception are Exchange Act Rule 15Fh– recognizes, however, that the SBS Operational Requirements 3(b) (disclosures of material risks and market continues to evolve and that In June 2019, the Commission characteristics and material incentives particular circumstances may arise in adopted final capital, margin and or conflicts of interest), Exchange Act which applying specific FINRA rules segregation requirements for SBS Rule 15Fh–3(f)(1) (recommendations not otherwise covered by the proposed Entities, along with amendments to the and suitability), Exchange Act Rule exceptions to SBS activities may not be existing capital and segregation 15Fh–3(g) (fair and balanced appropriate or feasible. Therefore, requirements for broker-dealers, in the communications) and Exchange Act proposed FINRA Rule 0180(i) would Capital, Margin, and Segregation Rule 15Fi–2 (acknowledgement and provide that, pursuant to the FINRA Release. As with many of its other Title 63 verification of SBS transactions). Rule 9600 Series, FINRA may, taking VII rulemakings, the SEC aligned the Where a member is acting as the U.S. into consideration all relevant factors, compliance date for the amendments Registered Affiliate for a foreign affiliate exempt a person unconditionally or on under the Capital, Margin, and pursuant to the exception in Exchange specified terms from the application of Segregation Release with the Act Rule 3a71–3(d), the member would FINRA rules (other than an exemption Registration Compliance Date.67 Among be required to comply with the SEC’s from the general application of other things, the Capital, Margin, and SBS Entity rules noted above. The paragraph (a) of proposed FINRA Rule Segregation Release amended the consequence of the member not 0180) to the person’s SBS activities or existing net capital rule for broker- complying with these rules is that the 68 positions as it deems appropriate dealers, Exchange Act Rule 15c3–1, in member’s foreign affiliate would be consistent with the protection of two key respects relevant to FINRA’s required to count such SBS toward its rules: investors and the public interest. Under de minimis SBSD registration threshold. • First, the SEC adopted new In these circumstances, FINRA believes this proposed provision, FINRA would minimum net capital requirements for it is appropriate to provide exceptions consider written applications for broker-dealers that are also registered as from the parallel FINRA rules to provide exemptive relief pursuant to FINRA SBSDs, but that do not operate pursuant clarity and avoid unnecessary regulatory Rule 9610 from the application of to the alternative net capital (‘‘ANC’’) duplication, but only where the member specific rules to a member’s SBS requirements of Exchange Act Rule is in fact complying with the specified activities or positions. Such 15c3–1 (‘‘Non-ANC Firms’’).69 Non- SEC rules. Specifically, proposed applications would be required to ANC Firms that are also registered as FINRA Rule 0180(e) would provide that address the need for exemptive relief SBSDs will need to comply with a new the following rules shall not apply to from specific FINRA rules on a rule-by- minimum dollar net capital requirement members’ activities and positions with rule basis, and FINRA would not and a new component for determining respect to SBS, to the extent that the provide exemptive relief from the their minimum capital requirement that member or the associated person of the application of FINRA rules generally to is based on a percentage of initial member, as applicable, is arranging, a member’s SBS activities or positions. margin computed for SBS (in addition negotiating or executing SBS on behalf Therefore, proposed FINRA Rule 0180(i) to other minimum requirements of a non-U.S. affiliate pursuant to, and would not provide for exemptive applicable to the broker-dealer).70 These in compliance with the conditions of, authority from the general application of changes do not apply to broker-dealers the exception from counting certain SBS FINRA rules to SBS under proposed that operate pursuant to the ANC under Exchange Act Rule 3a71–3(d)(1): FINRA Rule 0180(a). Pursuant to FINRA requirements of the rule (‘‘ANC Firms’’). (1) FINRA Rule 2111 (Suitability); (2) Rule 9620, FINRA would consider such These new minimum net capital FINRA Rule 2210(d) (Communications an application and issue a written requirements also will not impact Non- with the Public—Content Standards); decision to the requesting member, ANC Firms that are not also registered and (3) FINRA Rule 2232 (Customer which may be made publicly as SBSDs, regardless of whether such Confirmations).64 As noted above, the available.66 A member would have the Non-ANC Firms engage in SBS 71 availability of the exceptions under ability to appeal such a decision activities. proposed FINRA Rule 0180(e) would be pursuant to FINRA Rule 9630. FINRA 67 See Capital, Margin, and Segregation Release, conditioned on the member’s believes it is appropriate and in the compliance with the rules specified in supra note 8, at 43954. public interest to provide this 68 17 CFR 240.15c3–1. Exchange Act Rule 3a71–3(d)(1)(ii)(B) as exemptive authority so that FINRA can 69 Generally, a broker-dealer may apply to the if the member were the counterparty to account for specific situations that may SEC for authorization to use the alternative method the SBS transactions.65 for computing net capital contained in Appendix E arise with respect to SBS in the future to Exchange Act Rule 15c3–1. See 17 CFR Exemptive Authority on a case-by-case basis. 240.15c3–1(a)(7). Such broker-dealers are known as ‘‘ANC broker-dealers.’’ There are currently five As discussed above, in formulating FINRA also is proposing a conforming approved ANC broker-dealers. See SEC, Broker- the proposed rule change, FINRA change to FINRA Rule 9610 to add Dealers Using the Alternative Net Capital consulted with its members and FINRA Rule 0180 to the list of rules Computation under Appendix E to Rule 15c3–1, reviewed its rulebook to determine pursuant to which FINRA has https://www.sec.gov/tm/broker-dealers-alternative- net-capital-computation. Other broker-dealers are whether continuing exceptions from any exemptive authority. known as non-ANC broker-dealers and must compute net capital pursuant to the provisions of 63 See 17 CFR 240.3a71–3(d)(1)(ii)(B). 66 FINRA would consider any such application Exchange Act Rule 15c3–1. 64 FINRA believes these proposed exceptions are based on the specific circumstances described in 70 See 17 CFR. 240.15c3–1(a)(10). appropriate for similar reasons as the proposed the application and whether the requested 71 For example, the new minimum net capital exceptions for SBS Entities in proposed FINRA exemptive relief would be consistent with the requirements do not apply to a Non-ANC Firm Rules 0180(c) and (d). See supra notes 40 through protection of investors and the public interest. engaged in SBS dealing activity below the de 44 and 49 through 51 and accompanying text. FINRA expects that it would apply heightened minimis threshold for SBSD registration, or to a 65 A member acting as the U.S. Registered scrutiny to applications for exemptive relief from Non-ANC Firm engaged in SBS brokerage activity Affiliate under Exchange Act Rule 3a71–3(d) would members that are not also registered with the SEC or entering into non-dealing SBS transactions (e.g., remain subject to all other FINRA rules applicable as SBS Entities, and therefore not subject to the hedging). FINRA notes that the SEC also adopted to such SBS brokerage activity. See supra note 37. SEC’s regulatory framework for SBS. Continued

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• Second, the SEC changed the FINRA Rule 4120(a) requires each and two percent of the risk margin minimum net capital requirements for carrying or clearing firm to promptly, amount.77 Third, the SEC raised the ANC Firms, regardless of whether they but in any event within 24 hours, notify tentative net capital early warning transact in SBS. For ANC Firms, the FINRA in writing if its net capital falls notification threshold from $5 billion to SEC increased the minimum dollar net below any of the percentages specified $6 billion. In light of these increased capital requirement, added a new in subparagraphs (A) through (F) of capital requirements under the SEC’s component for determining the FINRA Rule 4120(a)(1). The proposed net capital rule, FINRA believes it is minimum capital requirement that is rule change would modify subparagraph appropriate to also modify the based on a percentage of initial margin (D), which applies to ANC Firms, and thresholds for required notification to computed for SBS (in addition to other also add new subparagraph (E), FINRA for ANC Firms under FINRA minimum requirements applicable to applicable to Non-ANC Firm members Rule 4120(a)(1)(D). Specifically, under the broker-dealer), increased the that are also registered SBSDs.75 the proposed rule change, an ANC Firm minimum tentative net capital Existing Exchange Act Rule 15c3– would be required to notify FINRA if, in requirement and amended the early 1(a)(7)(i) requires an ANC Firm to addition to the conditions currently warning notification requirement for maintain minimum tentative net capital prescribed under FINRA Rule tentative net capital.72 of not less than $1 billion and minimum 4120(a)(1)(A), (E) and (F): FINRA Rule 4120 (Regulatory net capital of not less than $500 million. • Its tentative net capital is less than Notification and Business Curtailment) In addition, existing Exchange Act Rule 150 percent of the minimum tentative sets forth certain early warning 15c3–1(a)(7)(ii) requires an ANC Firm to net capital amount required by notification and business curtailment provide an ‘‘early warning’’ notice to the Exchange Act Rule 15c3–1(a)(7)(i)(A) requirements if a member’s capital falls SEC when its tentative net capital falls (i.e., $5 billion, such that the below certain thresholds. Specifically, below $5 billion (or a lower threshold notification amount would be $7.5 FINRA Rule 4120(a) requires each if the SEC has granted an ANC Firm’s billion), carrying or clearing member to notify application to use such lower • the member is subject to the FINRA if its net capital falls below threshold). Subparagraph (D) of FINRA aggregate indebtedness requirement of certain specified levels.73 FINRA Rule Rule 4120(a) is based on these net Exchange Act Rule 15c3–1(a)(1)(i), and 4120(b) allows FINRA to restrict a capital requirements, requiring its net capital is less than the sum of member from expanding its business in notification to FINRA if the member is 1/10th of its aggregate indebtedness and certain circumstances and FINRA Rule an ANC Firm and (i) its tentative net 150 percent of the required percentage 4120(c) allows FINRA to require a capital under Exchange Act Rule 15c3– of the risk margin amount,78 or member to reduce its business if its net 1(c)(15) is less than 50 percent of the • the member elects to use the capital falls below certain specified early warning notification amount alternative method of computing net levels (generally lower than those required by Exchange Act Rule 15c3– capital pursuant to Exchange Act Rule required for notification under FINRA 1(a)(7)(ii) or (ii) its net capital is less 15c3–1(a)(1)(ii), and its net capital is Rule 4120(a)). These requirements are than $1.25 billion. In other words, less than the sum of the level specified based on the minimum capital notification to FINRA is required if an in Exchange Act Rule 17a–11(b)(2) 79 requirements applicable to a member ANC Firm’s tentative net capital falls and 150 percent of the required broker-dealer under Exchange Act Rule below $2.5 billion (or a lower amount, percentage of the risk margin amount.80 15c3–1. FINRA believes it is necessary if the ANC Firm has been permitted to FINRA believes these modified to amend FINRA Rule 4120 to conform use a lower early warning notice thresholds are appropriately calibrated the rule to the new and increased threshold), which is half of the SEC’s to provide FINRA with sufficient early minimum capital requirements for Non- early warning notification amount, or its warning that an ANC Firm’s capital ANC Firms that are also registered as net capital falls below $1.25 billion, levels may be deteriorating. By revising SBSDs and for ANC Firms, as described which is 2.5 times the SEC’s net capital the early warning levels as proposed, 74 above. requirement for ANC Firms. the proposed rule change aligns the In the Capital, Margin, and historical thresholds in FINRA Rule new minimum capital requirements for MSBSPs, Segregation Release, the SEC amended including that such entities must at all times have the net capital requirements for ANC and maintain a tangible net worth. See Capital, indebtedness standard if it complies with an Margin, and Segregation Release, supra note 8, at Firms in three ways. First, the SEC alternative method of computing net capital. See 17 43906–07. FINRA does not believe any changes to raised the tentative net capital CFR 240.15c3–1(a)(1)(ii). FINRA rules are necessary with respect to the new requirement for ANC Firms from $1 77 The ‘‘risk margin amount’’ means the total MSBSP capital requirements. billion to $5 billion. Second, the SEC initial margin for SBS. See 17 CFR 15c3–1(c)(17). 72 See 17 CFR 240.15c3–1(a)(7). The compliance Exchange Act Rule 15c3–1(a)(7)(i)(A) provides that date for the amended minimum net capital raised the minimum net capital initially the requirement will be two percent of the requirements for all ANC Firms is the Registration requirement for ANC Firms from $500 risk margin amount. However, the SEC may issue Compliance Date, i.e., October 6, 2021. million to the greater of $1 billion or the an order raising the requirement to four percent on 73 As discussed below, FINRA is also proposing or after the third anniversary of the amended rule’s sum of the applicable ratio requirement compliance date and to eight percent on or after the to apply all requirements in the FINRA Rule 4000 under Exchange Act Rule 15c3–1(a)(1) 76 Series applicable to carrying or clearing firms to fifth anniversary of the amended rule’s compliance members that act as principal counterparty to an date. See 17 CFR 15c3–1(a)(7)(i)(A)(2) and (3) and SBS, clear or carry an SBS, guarantee an SBS or calculation based on a firm’s liquid net worth, 15c3–1(a)(7)(i)(B). otherwise have financial exposure to an SBS. which includes all of a firm’s activities. 78 See supra note 77. 74 As noted above, the SEC did not amend 75 The proposed rule change would also make 79 See 17 CFR 240.17a–11(b)(2). Exchange Act Exchange Act Rule 15c3–1 to apply increased non-substantive and conforming changes to other Rule 17a–11 requires broker-dealers to promptly minimum capital requirements to Non-ANC Firms subparagraphs of FINRA Rule 4120(a) to reflect the notify the SEC after the occurrence of certain that engage in SBS activities but that are not insertion of new subparagraph (E), update cross- events. Exchange Act Rule 17a–11(b)(2) requires registered SBSDs. FINRA is therefore not proposing references to SEC rules that have been amended and such notification for broker-dealers using the to amend FINRA Rule 4120 to impose any reflect FINRA rulebook format conventions. alternative method of computing net capital additional minimum thresholds on such members. 76 See 17 CFR 240.15c3–1(a)(7)(i)(A). Under pursuant to Exchange Act Rule 15c3–1(a)(1)(ii) However, FINRA notes that, as a general matter, Exchange Act Rule 15c3–1(a)(1)(i), a broker-dealer when net capital is less than five percent of FINRA Rule 4120 would apply to all members that generally may not permit its aggregate indebtedness aggregate debit items under the Exchange Act Rule engage in SBS transactions (and any related to exceed 1500 percent of its net capital. A broker- 15c3–3 reserve formula. transactions) because net capital is a holistic dealer may elect not to be subject to the aggregate 80 See supra note 77.

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4120(a) for early warning notification 4120(a) for early warning notification is less than 40 percent of the early for ANC Firms with the revised capital with the new capital requirements warning notification amount required requirements applicable to such firms applicable to Non-ANC Firms that are by Exchange Act Rule 15c3–1(a)(7)(ii) or under the SEC’s amended rules. registered SBSDs under the SEC’s (ii) its net capital is less than $1 billion. Additionally, ANC Firms historically amended rules. These thresholds are based on the maintain capital far in excess of the FINRA Rule 4120(b) allows FINRA to current broker-dealer net capital rule. proposed amounts, so FINRA does not require a member that carries customer As described above, the SEC amended expect these levels to be problematic for accounts or clears transactions to not the net capital requirements for broker- firms to maintain. expand its business during any period dealers in the Capital, Margin, and In the Capital, Margin, and in which any of the conditions Segregation Release. Accordingly, under Segregation Release, the SEC also added described in paragraph (a)(1) of FINRA the proposed rule change, a member a new minimum net capital requirement Rule 4120 continue to exist for more that is an ANC Firm would be subject for Non-ANC Firms that are also than 15 consecutive business days, to the business curtailment provisions registered as SBSDs.81 Specifically, a provided that such condition(s) has of FINRA Rule 4120(c)(1) if, in addition Non-ANC Firm that is registered as an been known to FINRA or the member to the conditions currently prescribed SBSD must maintain minimum net for at least five consecutive business under FINRA Rule 4120(c)(1)(A), (E) capital of not less than the greater of $20 days. Since the proposed rule change and (F): million or the sum of the ratio would modify the conditions specified • Its tentative net capital is less than requirements under Exchange Act Rule in FINRA Rule 4120(a)(1) as described the amount specified under Exchange 15c3–1(a)(1) 82 and two percent of the above, the triggers for the application of Act Rule 15c3–1(a)(7)(ii) (i.e., the early risk margin amount.83 Accordingly, restrictions under FINRA Rule 4120(b) warning amount, $6 billion), FINRA believes it is necessary to add would be similarly affected. However, • the member is subject to the corresponding new thresholds for FINRA does not believe that any aggregate indebtedness requirement of required notification to FINRA for Non- conforming changes are needed at this Exchange Act Rule 15c3–1(a)(1)(i), and ANC Firms that are also registered time to the restrictions on business its net capital is less than the sum of SBSDs under new FINRA Rule expansion requirements under FINRA 1/12th of its aggregate indebtedness and 4120(a)(1)(E). Specifically, under the Rule 4120(b). FINRA notes that FINRA 125 percent of the required percentage proposed rule change, a Non-ANC Firm Rule 4120(b)(3)(A)–(G) includes a non- of the risk margin amount,88 or • that is also a registered SBSD would be exclusive list of activities that may the member elects to use the required to notify FINRA if, in addition constitute an ‘‘expansion of business’’ alternative method of computing net to the conditions currently prescribed for these purposes, and FINRA Rule capital pursuant to Exchange Act Rule under FINRA Rule 4120(a)(1)(A), (E) 4120(b)(3)(H) provides that the term 15c3–1(a)(1)(ii), and its net capital is and (F): ‘‘expansion of business’’ may include less than the sum of one percentage • The member is subject to the such other activities as FINRA deems point below the level specified in aggregate indebtedness requirement of appropriate under the circumstances, in Exchange Act Rule 17a–11(b)(2) 89 and Exchange Act Rule 15c3–1(a)(1)(i), and the public interest or for the protection 125 percent of the required percentage its net capital is less than the sum of of investors. FINRA believes that a of the risk margin amount.90 1/10th of its aggregate indebtedness and member firm’s SBS activities would be FINRA believes these modified 150 percent of the required percentage within the scope of ‘‘other activities’’ thresholds are appropriately calibrated of the risk margin amount,84 or contemplated by FINRA Rule to provide FINRA with the ability to • the member elects to use the 4120(b)(3)(H). require ANC Firms to reduce their alternative method of computing net FINRA Rule 4120(c) allows FINRA to business when their capital levels have capital pursuant to Exchange Act Rule require a member to reduce its business deteriorated to a level that may 15c3–1(a)(1)(ii), and its net capital is if its net capital falls below any of the jeopardize their ability to continue to less than the sum of the level specified percentages specified in subparagraphs comply with their capital requirements. in Exchange Act Rule 17a–11(b)(2) 85 (A) through (F) of FINRA Rule As described above, in the Capital, and 150 percent of the required 4120(c)(1). Similar to the proposed Margin, and Segregation Release, the percentage of the risk margin amount.86 modifications to FINRA Rule 4120(a) SEC also added a new minimum net FINRA believes it is appropriate to described above, the proposed rule capital requirement for Non-ANC Firms include specific thresholds for early change would modify subparagraph (D) that are also registered as SBSDs. notification to FINRA based on the new of FINRA Rule 4120(c)(1), which applies Accordingly, the proposed rule change minimum net capital requirements for to ANC Firms, and also add new would add corresponding new Non-ANC Firms that are registered subparagraph (E), applicable to Non- thresholds for business curtailment for ANC Firm members that are also Non-ANC Firms that are also registered SBSDs. FINRA also believes that the 87 thresholds described above are registered SBSDs. SBSDs under new FINRA Rule Current subparagraph (D) of FINRA appropriately calibrated to provide 4120(c)(1)(E). Specifically, under the Rule 4120(c)(1) permits business FINRA with sufficient early warning proposed rule change, a Non-ANC Firm curtailment if the member is an ANC that such a firm’s capital levels may be that is also a registered SBSD would be Firm and (i) its tentative net capital deteriorating. By defining the early subject to the business curtailment under Exchange Act Rule 15c3–1(c)(15) warning levels as proposed, the provisions of FINRA Rule 4120(c)(1) if, in addition to the conditions currently proposed rule change aligns the 87 The proposed rule change would also make historical thresholds in FINRA Rule non-substantive and conforming changes to other prescribed under FINRA Rule subparagraphs of FINRA Rule 4120(c)(1) to reflect 4120(c)(1)(A), (E) and (F): • 81 See 17 CFR 15c3–1(a)(10). the insertion of new subparagraph (E), update cross- The member is subject to the 82 See supra note 76. references to SEC rules that have been amended and aggregate indebtedness requirement of 83 reflect FINRA rulebook format conventions. Similar See supra note 77. non-substantive changes would be made to 84 See supra note 77. paragraph (b)(1) and Supplementary Material .01 to 88 See supra note 77. 85 See supra note 79. FINRA Rule 4120 to reflect FINRA rulebook format 89 See supra note 79. 86 See supra note 77. conventions. 90 See supra note 77.

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Exchange Act Rule 15c3–1(a)(1)(i), and tiering has been employed for carrying has financial exposure to an SBS.95 its net capital is less than the sum of or clearing firms and a brief description FINRA believes that applying these 1/12th of its aggregate indebtedness and of the tiered requirements for such higher standards when a member enters 125 percent of the required percentage firms: into SBS or otherwise has exposure to of the risk margin amount,91 or • FINRA Rule 4110 (Capital SBS is appropriate and consistent with • the member elects to use the Compliance) includes requirements for the protection of investors and the alternative method of computing net carrying or clearing firms to keep greater public interest. capital pursuant to Exchange Act Rule net capital, seek permission for Margin Requirements 15c3–1(a)(1)(ii), and its net capital is withdrawals of capital and seek less than the sum of one percentage approval for certain add-backs to net As discussed above, in June 2019 the point below the level specified in capital. Commission adopted its final Capital, 92 Margin, and Segregation Release, with a Exchange Act Rule 17a–11(b)(2) and • FINRA Rule 4120 (Regulatory compliance date aligned with the 125 percent of the required percentage Notification and Business Curtailment) 93 Registration Compliance Date.96 Among of the risk margin amount. includes restrictions on expanding, or FINRA believes it is appropriate to other things, the Capital, Margin, and requirements to reduce business, if include specific thresholds for business Segregation Release adopted new sufficient capital levels are not curtailment based on the new minimum Exchange Act Rule 18a–3, which maintained. net capital requirements for Non-ANC • prescribes margin requirements for Firms that are registered SBSDs. FINRA FINRA Rule 4521 (Notifications, nonbank SBSDs with respect to also believes that the thresholds Questionnaires and Reports) allows uncleared SBS.97 Generally, Exchange described above are appropriately FINRA to collect additional data and Act Rule 18a–3 requires a nonbank calibrated to provide FINRA with the require reporting of a material decline in SBSD to calculate, for each account of ability to require such firms to reduce tentative net capital. an SBS counterparty as of the close of • their business when their capital levels FINRA Rule 4522 (Periodic Security business of each day: (i) The amount of have deteriorated to a level that may Counts, Verification and Comparison) current exposure in the account (i.e., jeopardize their ability to continue to requires more frequent security counts, variation margin) and (ii) the initial comply with their capital requirements. verifications and comparisons than margin amount for the account.98 Under Lastly, FINRA notes that FINRA Rule would be required under Exchange Act Exchange Act Rule 18a–3, variation 4120(c)(3)(A)–(J) includes a non- Rule 17a–13.94 margin must be calculated by marking exclusive list of activities that may • FINRA Rule 4523 (Assignment of the position to market, while initial constitute a ‘‘business reduction’’ for Responsibility for General Ledger margin must generally be calculated these purposes, and FINRA Rule Accounts and Identification of Suspense using standardized haircuts, which are 4120(c)(3)(K) provides that the term Accounts) requires a record of primary prescribed in Exchange Act Rule ‘‘business reduction’’ may include such and supervisory named individuals over 15c3–1 for nonbank SBSDs that are other activities as FINRA deems general ledger bookkeeping accounts. registered broker-dealers.99 Nonbank appropriate under the circumstances, in The intent of the tiering employed in SBSDs may apply to the SEC for the public interest or for the protection these rules in the FINRA Rule 4000 authorization to use models to calculate of investors. FINRA believes that a Series is to impose higher capital, initial margin instead of the member firm’s SBS activities would be recordkeeping and operational standardized haircuts (including the within the scope of ‘‘other activities’’ standards on firms that carry or clear option to use the more risk sensitive contemplated by FINRA Rule transactions and accounts, and therefore methodology in Exchange Act Rule 4120(c)(3)(K). may have financial exposure to 15c3–1a), but nonbank SBSDs that are In addition to these conforming customers, other broker-dealers, central changes to FINRA Rule 4120, the counterparties or others. FINRA believes 95 Although this proposed tiering provision proposed rule change would apply that similar considerations apply for relates to the financial responsibility and operational rules, FINRA believes it should be FINRA’s financial and operational rules members with exposure to SBS. SBS are included as a paragraph in proposed FINRA Rule more broadly to firms that enter into, or complex transactions that will, by their 0180 so that all provisions relating to the treatment otherwise have exposure to, SBS. nature, require detailed recordkeeping, of SBS under FINRA rules are found in a single, Specifically, certain rules in the FINRA margining, legal agreements, collateral consolidated rule. 96 See Capital, Margin, and Segregation Release, Rule 4000 Series (Financial and management, reconciliation and risk supra note 8, at 43954. Operational Rules) include provisions management. FINRA therefore believes 97 See 17 CFR 240.18a–3. Exchange Act Rule that impose higher standards, or provide it is appropriate to also employ tiering 18a–3 also prescribes margin requirements for FINRA the authority to impose in the FINRA Rule 4000 Series for nonbank MSBSPs with respect to uncleared SBS. As discussed above, Exchange Act Rule 18a–3 additional requirements, on firms that members that enter into SBS on a generally requires SBSDs to collect or deliver carry or clear transactions or accounts principal basis or otherwise have variation margin, and also to collect initial margin, (generally referred to as ‘‘carrying or financial exposure to SBS. Specifically, with respect to its SBS counterparties. However, clearing firms’’). This ‘‘tiering’’ structure under the proposed rule change, Exchange Act Rule 18a–3 requires that a nonbank MSBSP only collect and deliver variation margin, was built into certain rules so that firms proposed FINRA Rule 0180(h) would without prescribing any initial margin requirement. that only introduce their customer provide that, for purposes of the FINRA See Capital, Margin, and Segregation Release, supra accounts and do not have exposure to Rule 4000 Series, all requirements that note 8, at 43877. As discussed below, FINRA the settlement system are provided believes it is appropriate to apply variation margin apply to a member that clears or carries and initial margin requirements to all of its relief from the higher standards required customer accounts shall also apply to members that transact in uncleared SBS. Therefore, of firms that carry or clear transactions any member that acts as a principal proposed FINRA Rule 4240 would provide an and accounts. Below is a list of rules in counterparty to an SBS, clears or carries exception for members that are registered as SBSDs (and therefore subject to the variation and initial the FINRA Rule 4000 Series where an SBS, guarantees an SBS or otherwise margin requirements of Exchange Act Rule 18a–3), but not for members that are registered as MSBSPs. 91 See supra note 77. 94 See 17 CFR 240.17a–13. Exchange Act Rule 98 See 17 CFR 240.18a–3(c)(1)(i); Capital, Margin, 92 See supra note 79. 17a–13 generally requires broker-dealers to perform and Segregation Release, supra note 8, at 43876. 93 See supra note 77. quarterly security counts. 99 See 17 CFR 240.18a–3(d).

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registered broker-dealers must use from systemic risk posed by CDS.103 regulatory gap, protect FINRA members standardized haircuts to calculate initial Pending the SEC’s final implementation against counterparty credit risk, margin for uncleared equity SBS.100 of the Title VII rulemakings, FINRA has maintain a level playing field for Based on these calculations, Exchange extended the expiration date of the members and prevent regulatory Act Rule 18a–3 generally requires a Interim Pilot Program a number of arbitrage. As described in further detail nonbank SBSD to collect and deliver times, mostly recently in June 2020.104 below, the margin requirements under variation margin, and to collect (but not The Interim Pilot Program under current proposed FINRA Rule 4240 would be deliver) initial margin.101 Exchange Act FINRA Rule 4240 is currently set to structurally aligned with the margin Rule 18a–3 also provides certain expire on September 1, 2021, the same requirements that will apply to nonbank exceptions from the margin date that current FINRA Rule 0180 is set SBSDs under Exchange Act Rule 18a–3, requirements, establishes thresholds to expire.105 with certain modifications that FINRA and minimum transfer amounts, In light of the finalization of the SEC’s believes are necessary given that such specifies collateral requirements margin requirements for nonbank members will not be subject to the SEC’s (including collateral haircuts), SBSDs under Exchange Act Rule 18a–3 comprehensive regulatory framework establishes risk monitoring and the upcoming Registration for SBSDs. Thus, subject to certain requirements and includes other Compliance Date, FINRA believes it is exceptions described in the proposed miscellaneous provisions, such as appropriate and in the public interest rule, proposed FINRA Rule 4240 would definitions. All nonbank SBSDs, for the Interim Pilot Program to expire require members that are not SBSDs to including nonbank SBSDs that are and for FINRA to adopt a new margin collect and deliver variation margin on 106 FINRA members, will become subject to rule specifically applicable to SBS. a daily basis to cover the member’s the margin requirements set forth in Accordingly, under the proposed rule current exposure to or from each Exchange Act Rule 18a–3 beginning on change, current FINRA Rule 4240 would uncleared SBS counterparty, and also to the Registration Compliance Date. be replaced by a new FINRA Rule 4240 collect (but not deliver) initial margin on October 6, 2021 that would prescribe from each SBS counterparty. The FINRA Rule 4200 Series sets forth margin requirements for SBS. Consistent Proposed FINRA Rule 4240 is divided margin requirements applicable to with Exchange Act Rule 18a–3—and into a header followed by paragraphs (a) FINRA members. In particular, FINRA unlike the Interim Pilot Program— through (d). The header would specify Rule 4210 describes the margin proposed new Rule 4240 would apply the scope of the margin requirements requirements that determine the amount margin requirements to all SBS, not just under proposed FINRA Rule 4240. of equity or ‘‘margin’’ customers are CDS. However, proposed new FINRA Paragraph (a) would describe the margin expected to maintain in their securities Rule 4240 would not apply to any requirements for cleared SBS. Paragraph accounts, including margin member that is registered as an SBSD, (b) would describe the margin requirements for equity and fixed as such members will be subject to the requirements for uncleared SBS. income securities as well as options, margin requirements of Exchange Act Specifically, paragraph (b)(1) would set warrants and security futures. Current Rule 18a–3 as summarized above. forth how variation margin must be FINRA Rule 4240 separately establishes Additionally, and consistent with the calculated, paragraph (b)(2) would set an interim pilot program with respect to SEC’s approach under the Act and forth how initial margin must be margin requirements for any Exchange Act Rule 18a–3, proposed calculated, paragraph (b)(3) would transactions in CDS held in an account FINRA Rule 4240 would defer to prescribe the collection and delivery at a member (the ‘‘Interim Pilot registered clearing agencies to set the requirements for variation and initial Program’’). Under current FINRA Rule margin requirements for cleared SBS, margin, paragraph (b)(4) would specify 0180, FINRA Rule 4210 does not apply and as such would only specify new the manner and time of collection or to members’ activities and positions variation margin and initial margin delivery of variation and initial margin, with respect to SBS, but current FINRA requirements for uncleared SBS. and paragraph (b)(5) would list certain Rule 4240 does apply to activities and Therefore, the specific new margin exceptions from the margin positions within its scope. Therefore, to requirements prescribed under requirements. Paragraph (c) would the extent that a FINRA member enters proposed FINRA Rule 4240 would only require members to employ specified into SBS that are CDS, the margin apply to uncleared SBS transacted by risk monitoring procedures and requirements under the Interim Pilot FINRA members that are not registered 102 guidelines for uncleared SBS. Finally, Program apply to such SBS. SBSDs. FINRA believes that, by paragraph (d) would define certain However, the Interim Pilot Program is a applying margin requirements in these terms used in proposed FINRA Rule temporary rule, and SBS that are not circumstances, the proposed rule 4240. Each of these aspects of the CDS are not currently subject to any change would fill an important proposed rule change is described in margin requirements under FINRA further detail below. rules. 103 See Securities Exchange Act Release No. Proposed FINRA Rule 4240 would be 59955 (May 22, 2009), 74 FR 25586 (May 28, 2009) The Interim Pilot Program was (Order Approving File No. SR–FINRA–2009–012). entitled ‘‘Security-Based Swap Margin originally proposed by FINRA and 104 See supra note 16. Requirements.’’ 107 The header text to approved by the Commission in 2009 105 See supra note 18. specifically to address concerns arising 106 FINRA notes that, under the proposed rule 107 In addition to the new provisions under change, proposed FINRA Rule 0180 would no proposed FINRA Rule 4240 discussed above, the longer provide an exception from current FINRA implementation of new margin requirements for 100 See supra note 99; Capital, Margin, and Rule 4210 applying to members’ activities and SBS under proposed FINRA Rule 4240 will also Segregation Release, supra note 8, at 43876. positions with respect to SBS. Absent additional require a conforming change to FINRA Rule 4220 101 See 17 CFR 240.18a–3(c)(1)(ii). changes, therefore, the general margin requirements (Daily Record of Required Margin). FINRA Rule 102 For purposes of current FINRA Rule 4240, the under FINRA Rule 4210 would apply to SBS. 4220 requires each member carrying securities term ‘‘credit default swap’’ includes any product However, as described above, FINRA believes margin accounts for customers to make a record that is commonly known to the trade as a ‘‘credit specifically listing SBS within the exceptions listed each day of every case in which initial or additional default swap’’ and is an SBS as defined pursuant in FINRA Rule 4210, and adopting a separate, new margin must be obtained in a customer’s account. to Section 3(a)(68) of the Act or the rules and FINRA Rule 4240 applicable to SBS, would To ensure that similar records are maintained for guidance of the SEC and its staff. See FINRA Rule promote legal certainty and provide clarity to its SBS margin required under proposed new FINRA 4240(a). members. Continued

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the rule would state that each member SBSDs rather than impose additional or Uncleared SBS Account plus the Value that is a party to an SBS with a different requirements on such entities. of all Variation Margin collected from customer, broker or dealer, or other Proposed FINRA Rule 4240(a), the Counterparty minus the Value of all Counterparty,108 or who has guaranteed entitled ‘‘Cleared SBS Margin Variation margin delivered to the or otherwise become responsible for any Requirements,’’ would state that, except Counterparty.111 This provision would other person’s SBS obligations, shall as provided in paragraph (b)(5) (i.e., define a member’s Current Exposure for comply with the requirements of specified exceptions from proposed purposes of collecting or delivering proposed FINRA Rule 4240, except that FINRA Rule 4240, discussed below), the Variation Margin under proposed a member that is registered as an SBSD margin to be maintained on any Cleared FINRA Rule 4240(b)(3), discussed shall instead comply with Exchange Act SBS is the margin on such Cleared SBS below, by taking into account the net required by the Clearing Agency Rule 18a–3. This provision of the Value of SBS in the Counterparty’s through which such SBS is Cleared. As proposed rule is intended to clarify that account together with any Variation discussed above, this provision clarifies the margin requirements under Margin that has already been collected that proposed FINRA Rule 4240 defers or delivered. FINRA believes this proposed FINRA Rule 4240 apply in all to registered clearing agencies to set the calculation is consistent with the circumstances where a member is a margin requirements for cleared SBS. variation margin requirements under party to a SBS, regardless of the type of FINRA believes that it is appropriate to Exchange Act Rule 18a–3. counterparty, and also where a member defer to clearing agencies to establish Proposed FINRA Rule 4240(b)(2), has financial exposure to an SBS, margin requirements for cleared SBS in entitled ‘‘Initial Margin Computation,’’ whether through a guarantee or other light of the SEC’s comprehensive would require that, as of the close of arrangements under which the member regulation of clearing agencies, business on each business day, the is responsible for another person’s SBS including their required margin levels, member compute the Initial Margin obligations. FINRA believes that this under the Act. Requirement for each Uncleared SBS provision is necessary to ensure that the Proposed FINRA Rule 4240(b), Account equal to the sum of the Initial proposed margin requirements entitled ‘‘Uncleared SBS Margin Margin Requirements on the Uncleared adequately protect member firms against Requirements,’’ would set forth the SBS and securities positions in that counterparty credit risk, regardless of substantive margin requirements Uncleared SBS Account. The remainder the specific manner through which the applicable to members that are not of proposed FINRA Rule 4240(b)(2) member has become exposed to such SBSDs when such members transact in describes how a member must calculate risk. Additionally, as discussed above, Uncleared SBS. Paragraph (b)(1), the Initial Margin Requirement, which this provision clarifies that members entitled ‘‘Current Exposure is then used for purposes of collecting that are registered SBSDs are not subject Calculation,’’ would require that, as of Initial Margin under proposed FINRA to the proposed margin requirements the close of business of each business Rule 4240(b)(3), discussed below.112 because they are instead required to day, the member calculate with respect Under the proposed rule change, the 109 comply with Exchange Act Rule 18a–3. to each Uncleared SBS Account the Initial Margin Requirement would FINRA believes it should defer to the Counterparty’s Current Exposure to the depend on the type of uncleared SBS SEC’s margin framework for registered member (if positive) or the member’s involved, with different requirements Current Exposure to the Counterparty (if depending on whether the uncleared negative). Current Exposure would be Rule 4240, the proposed rule change would update SBS is (i) a ‘‘plain vanilla’’ CDS; (ii) a FINRA Rule 4220 to also require such records for calculated as an amount equal to the net 110 each member subject to proposed FINRA Rule 4240. Value of all Uncleared SBS in the in U.S. dollars would be the amount of such cash, In addition, the proposed rule change would add while the Value of freely convertible foreign new Supplementary Material .06 to FINRA Rule 109 Under proposed FINRA Rule 4240(d)(19), an currency would be the amount of U.S. dollars into 4210 to clarify that a Regulation T good faith ‘‘Uncleared SBS Account’’ would be defined to which the currency could be converted, provided account, other than a non-securities account, is a mean an account with respect to a Counterparty the currency is marked-to-market daily. margin account for purposes of FINRA Rule 4210. consisting of all Uncleared SBS between the 111 Under proposed FINRA Rule 4240(d)(21), This provision is intended merely to codify member and the Counterparty, together with long ‘‘Variation Margin’’ would be defined to mean the FINRA’s existing interpretation regarding the scope or short positions for Variation Margin in the form cash or margin securities collected from, or of FINRA Rule 4210. The proposed rule change of securities collected or delivered, respectively, delivered to, a Counterparty in accordance with would also include a parallel provision in new credit or debit balances for Variation Margin in the proposed FINRA Rule 4240(b)(3)(A), as discussed Supplementary Material .01 to proposed new Rule form of cash collected or delivered, respectively, below. Under proposed FINRA Rule 4240. and long positions or credit balances for Initial 4240(b)(2)(A)(iii), all securities deposited as Finally, the proposed rule change would make Margin collected in the form of securities or cash, Variation Margin for Uncleared SBS would two other conforming changes to FINRA Rule 4210, respectively. The definitions of ‘‘Variation Margin’’ themselves be margined in accordance with FINRA including to add proposed new FINRA Rule and ‘‘Initial Margin’’ are discussed below. Rule 4210, unless the member has chosen to haircut 4240(e)(9) and to make a technical adjustment to 110 ‘‘Value’’ would be defined in proposed FINRA them for purposes of determining their Value. See FINRA Rule 4240(g)(2)(H). These proposed changes Rule 4240(d)(20). Under this definition, the Value supra note 110. are discussed below. of one or more SBS would be the mid-market 112 Under proposed FINRA Rule 4240(d)(9), the 108 ‘‘Counterparty’’ would be defined under replacement cost for such SBS. The Value of a term ‘‘Initial Margin’’ would be defined to mean all proposed FINRA Rule 4240(d)(5) to mean a person security position would be the current market value cash or marginable securities, excluding Variation with whom a member has entered into an of such margin securities, as defined in FINRA Rule Margin, received by the member for a Uncleared SBS. An ‘‘SBS’’ would be defined in 4210(a)(2) and determined in accordance with Counterparty’s Uncleared SBS Account or proposed FINRA Rule 4240(d)(16) by reference to FINRA Rule 4210(f)(1) (i.e., the provisions of transferred to the Counterparty’s Uncleared SBS the definition of ‘‘security-based swap’’ under FINRA’s general margin rule used to determine the Account from another account at the member, Section 3(a)(68) of the Act and ‘‘Uncleared’’ would current market value of margin securities). including margin collected from a Counterparty in be defined in proposed FINRA Rule 4240(d)(18) as Alternatively, a member could elect to determine accordance with proposed FINRA Rule an SBS that is not Cleared. Under proposed FINRA the Value of margin securities collected as Variation 4240(b)(3)(B), as discussed below, that in each case Rule 4240(d)(3), an SBS would be considered Margin or Initial Margin by applying a haircut to have not been returned to the Counterparty or Cleared if it is cleared through a Clearing Agency the current market value of such securities equal to applied to an obligation of the Counterparty. Under by or on behalf of the member, and Clearing Agency the margin requirement that would be applicable to proposed FINRA Rule 4240(b)(2)(A)(iii), all would be defined under proposed FINRA Rule them under FINRA Rule 4210 if they were held in securities deposited as Initial Margin for Uncleared 4240(4) as a clearing agency registered pursuant to the Counterparty’s margin account (in which case, SBS would themselves be margined in accordance Section 17A of the Act or exempted by the SEC however, such margin securities would not be with FINRA Rule 4210, unless the member has from such registration by a rule or order pursuant required to be themselves margined under proposed chosen to haircut them for purposes of determining to Section 17A of the Act. FINRA Rule 4240(b)(2)(A)(iii)). The Value of cash their Value. See supra note 110.

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‘‘plain vanilla’’ SBS other than an CDS determining initial margin for CDS in determining their Value; 116 (iii) options (i.e., an SBS that is the economic this manner would promote regulatory positions must be in the Counterparty’s equivalent of a margin account consistency and reduce potential margin account at the member; (iv) no containing a portfolio of long or short arbitrage. Additionally, the haircuts SBS, security or option positions may be positions in securities or options, such prescribed in Exchange Act Rule 15c3– included in more than one combination; as a ‘‘plain vanilla’’ equity total return 1(c)(2)(vi)(P) are substantially similar to and (v) no combinations may include swap (‘‘TRS’’)); or (iii) any other type of existing FINRA Rule 4240 margin securities or options positions for which SBS (e.g., a complex CDS or equity TRS requirements, so in effect the proposed reduced margin requirements are that would not be considered ‘‘plain requirements have already been used computed under FINRA Rule 4210(e)(1) vanilla’’ under the proposed rule, during the Interim Pilot Program. (i.e., reduced margin requirements for including for example a CDS swaption, Second, the Initial Margin Requirement offsetting long and short positions) or or a dividend swap). FINRA believes for a Basic SBS would generally be 4210(f)(2)(F)(ii) through (f)(2)(l) (i.e., that differentiation as to initial margin computed by applying FINRA Rule 4210 various reduced margin requirements requirements among these different to the Equivalent Margin Account. Since for certain options, including covered types of SBS is appropriate and an Uncleared Basic SBS would be the options and offsetting options necessary given the unique economic equivalent of a margin positions). FINRA believes these characteristics and risks posed by account that would otherwise be conditions would ensure that the Initial different SBS products. governed by the margin provisions of Margin Requirement calculated using Proposed paragraphs (b)(2)(A)(i) and FINRA Rule 4210, FINRA believes it is the combination method is based on (ii) would define the Initial Margin appropriate to treat such SBS similarly. securities and options positions that the Requirements for uncleared plain In addition, proposed FINRA Rule member actually has in its possession vanilla CDS (referred to as ‘‘Basic 4240(b)(2)(A) would permit the Initial and does not reflect reductions in value CDS’’) 113 and other uncleared ‘‘plain Margin Requirements for both that would inappropriately lower the vanilla’’ SBS (referred to as ‘‘Basic Uncleared Basic CDS and Uncleared margin requirement. In addition, 114 SBS’’), respectively. First, the Initial Basic SBS to be computed based on a proposed FINRA Rule 4240(b)(2)(B) Margin Requirement for an Uncleared combination of multiple SBS and would provide that if the Initial Margin Basic CDS would generally be computed securities or options positions, as Requirement is computed on a based on the term and spread of the applicable and subject to certain combination as described above, the Uncleared Basic CDS, using the chart conditions. Specifically, proposed Initial Margin Requirement on the and offsets set out in Exchange Act Rule FINRA Rule 4240(b)(2)(A)(i) would Uncleared SBS included in the 115 15c3–1(c)(2)(vi)(P). The proposed provide that, if the member has a netting combination shall be reduced (but not rule would therefore follow Exchange or collateral agreement that is legally below zero) by the aggregate Act Rule 18a–3(d)(1)(i) by determining enforceable against the Counterparty maintenance margin requirements the Initial Margin Requirement for and covers any combination of under FINRA Rule 4210 applicable to Uncleared Basic CDS using the haircuts Uncleared Basic CDS or securities such margin account positions. FINRA applicable to such SBS under the SEC’s specified in clause (iii), (iv) or (v) of believes that this provision would net capital rule. FINRA believes that Exchange Act Rule 15c3–1(c)(2)(vi)(P)(1) appropriately take into account margin already collected under FINRA Rule 113 (i.e., specified offsetting debt securities), Under proposed FINRA Rule 4240(d)(1), a 117 ‘‘Basic CDS’’ would be defined to mean a Basic the member may compute the Initial 4210 with respect to such positions. Single Name Credit Default Swap or a Basic Margin Requirement on such The proposed rule change would not Narrow-Based Index Credit Default Swap. A Basic combination of positions equal to the specify Initial Margin Requirements for Single-Name Credit Default Swap would mean an ‘‘haircut’’ on that combination under other Uncleared SBS that do not qualify SBS in which one party pays either a single fixed as Basic CDS or Basic SBS. Instead, amount or periodic fixed amounts or floating Exchange Act Rule 15c3– amounts determined by reference to a specified 1(c)(2)(vi)(P)(1). Proposed FINRA Rule proposed FINRA Rule 4240(b)(2)(A)(iv) notional amount, and the other party pays either a 4240(b)(2)(A)(ii) would similarly would provide that the Initial Margin fixed amount or an amount determined by reference provide that, if the member has a netting Requirement for any Uncleared SBS to the value of one or more loans, debt securities or other financial instruments issued, guaranteed or or collateral agreement that is legally other than a Basic CDS or Basic SBS otherwise entered into by a third party (i.e., the enforceable against the Counterparty ‘‘Reference Entity’’) upon the occurrence of one or and covers any combination of 116 See supra note 110. more specified credit events with respect to the Uncleared Basic SBS, securities or 117 In connection with this proposed provision of Reference Entity (for example, bankruptcy or FINRA Rule 4240(b)(2)(B), the proposed rule change payment default). The term ‘‘Basic Single-Name options positions, the member may would also add a new paragraph (e)(9) to FINRA Credit Default Swap’’ would also include a swap compute the Initial Margin Requirement Rule 4210, entitled ‘‘Security-Based Swaps; SBS that, upon the occurrence of one or more specified on the combination of such positions Offsets.’’ Specifically, where the Initial Margin credit events with respect to the Reference Entity, equal to the margin that FINRA Rule Requirement on the combination of SBS and a is physically settled by payment of a specified fixed securities or options position in the margin account amount by one party against delivery by the other 4210 would require to be maintained on would be less than the FINRA Rule 4210 party of eligible obligations of the Reference Entity. the combination of Equivalent Margin maintenance requirement on the margin account A Basic Narrow-Based Index Credit Default Swap Accounts for such Uncleared Basic SBS positions, proposed FINRA Rule 4210(e)(9) would would be defined to mean an SBS consisting of and securities or options positions. reduce the FINRA Rule 4210 maintenance multiple component Basic Single-Name Credit requirement on the margin account positions to Default Swaps. Proposed FINRA Rule 4240(b)(2)(B) equal the computed Initial Margin Requirement. 114 Under proposed FINRA Rule 4240(d)(2), a would impose conditions on computing In addition, proposed FINRA Rule 4210(e)(9) ‘‘Basic SBS’’ would be defined to mean an SBS, the Initial Margin Requirement using would clarify that, except for SBS carried by a other than a CDS, under which each party is these combination methods, including member in a portfolio margin account subject to the contractually obligated to provide the other the requirements of FINRA Rule 4210(g), as discussed economic equivalent of a margin account that (i) securities positions must be in below, margin requirements on SBS and positions containing a portfolio of long or short positions in the Counterparty’s Uncleared SBS in Uncleared SBS Accounts are determined by securities or options (i.e., an ‘‘Equivalent Margin Account or margin account at the proposed FINRA Rule 4240, rather than FINRA Account’’). member; (ii) securities may not be Rule 4210. FINRA believes that including this 115 See 17 CFR 240.15c3–1(c)(2)(vi)(P). This express statement regarding the applicability of provision of the SEC’s broker-dealer net capital rule included if the member has chosen to each of its margin rules to SBS would enhance defines the haircuts applicable to uncleared SBS. haircut them for purposes of clarity and reduce legal uncertainty for its members.

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would be determined in a manner complex financial instruments that pose Proposed FINRA Rule 4240(b)(4), approved by FINRA pursuant to substantial risks to members and margin entitled ‘‘Manner and Time of proposed FINRA Rule 4240(b)(2)(C), serves as an important means of Collection or Delivery of Variation and which would permit a member to apply protecting member firms, and thereby Initial Margin; Prohibited Returns and to FINRA for the approval of an Initial their customers and investors, from Withdrawals,’’ would set forth Margin Requirement for any other type such risks. FINRA therefore believes additional detailed requirements and of SBS. Under the proposed rule change, that members that are not SBSDs (and clarifications regarding the manner and any such application would be required therefore not subject to the SEC’s time of collection or delivery of to: comprehensive regulatory framework variation and initial margin, as • Define the specific type of SBS for registrants under Title VII of Dodd- calculated pursuant to proposed FINRA covered by the application; Frank) should not be permitted to enter Rules 4240(b)(1) and (2) and collected or • describe the purpose(s) that the into other types of SBS unless and until delivered in accordance with proposed member and its Counterparties would FINRA has evaluated the risks of such FINRA Rule 4240(b)(3), as described have for entering that type of SBS; SBS and approved margin requirements above. Specifically, proposed FINRA • identify all variables that influence that adequately address such risks. If Rule 4240(b)(4) would provide for the the value of that type of SBS; • FINRA determines that a proposed following: explain all risks of that type of SBS; margin requirement does not adequately • Under proposed FINRA Rule • propose a specific Initial Margin address the risks for a particular type of 4240(b)(4)(A), margin would be deemed Requirement (not a margin model) for SBS, FINRA would not approve the collected or returned to the member that type of SBS; when it is received in the • explain how the proposed specific application under proposed FINRA Rule Counterparty’s Uncleared SBS Account Initial Margin Requirement would 4240(b)(2)(C), and members would not at the member (or transferred to such adequately protect a member and its be permitted to enter into such SBS. To account from another account at the capital against each of those risks; FINRA’s knowledge, this SBS activity • by members that do not plan to register member). attach copies of the member’s SBS • risk management procedures and as SBSDs is relatively limited. Under proposed FINRA Rule describe the application of those Proposed FINRA Rule 4240(b)(3), 4240(b)(4)(B), margin would be deemed procedures to that type of SBS; and entitled ‘‘Collection or Delivery of collected or returned to the • provide the results of backtesting of Variation and Initial Margin,’’ would set Counterparty when it is transferred from the proposed specific Initial Margin forth a member’s obligation to collect or the Counterparty’s Uncleared SBS Requirement over periods of significant deliver margin as calculated pursuant to Account at the member in accordance volatility in the variables influencing proposed FINRA Rule 4240(b)(1) and with the Counterparty’s instructions or the value of that type of SBS. (2), described above. Paragraph (b)(3)(A) agreement with the member, which Proposed FINRA Rule 4240(b)(2)(C) would require each member to deliver could potentially include transfer to would further provide that, if FINRA or return to each Counterparty cash or another account of the Counterparty approves any such application, the margin securities with a Value equal to carried by the member. • approval may be unconditional or the Counterparty’s Current Exposure (if Under proposed FINRA Rule conditional, including in the form of a any) to the member, or collect or 4240(b)(4)(C), margin would be required time-limited pilot program; may retrieve from the Counterparty cash or to be collected or delivered pursuant to approve the use of the specific Initial margin securities with a Value equal to proposed FINRA Rule 4240(b)(3) as Margin Requirement only by the the member’s Current Exposure (if any) promptly as possible, but in any case no applicant; or may take the form of a to the Counterparty. Paragraph (b)(3)(B) later than the close of business on the Regulatory Notice or other would require each member to collect business day after the date on which the communication approving the use of the from each Counterparty cash or margin Current Exposure or Initial Margin specific margin requirements by securities with a Value at least equal to Requirement was required to be members generally. Under proposed any Initial Margin Deficit.118 Therefore, computed in accordance with proposed FINRA Rule 4240(b)(2)(C), no member consistent with Exchange Act Rule 18a– FINRA Rule 4240(b)(1) or (2) (i.e., would be permitted to become a party 3, proposed FINRA Rule 4240(b)(3) margin would generally be required to to an SBS other than a Basic CDS or would require members that are not be delivered or collected on a T+1 Basic SBS unless FINRA has approved SBSDs to collect and deliver Variation basis). Further, unless FINRA has an Initial Margin Requirement for such Margin, and also to collect (but not specifically granted the member member’s use with respect to that type deliver) Initial Margin, in amounts additional time, a member that has not of SBS. As described above, the Initial determined pursuant to the provisions collected margin as required by the Margin Requirements for Basic CDS are of FINRA Rule 4240(b)(1) and (2) close of business on the third business based on the SEC’s treatment of such described above, for their transactions day (i.e., by T+3) would be required to SBS under its net capital rule, while the in Uncleared SBS.119 take prompt steps to liquidate positions Initial Margin Requirements for Basic in the Counterparty’s Uncleared SBS SBS are based on the margin that would 118 Under proposed FINRA Rule 4240(d)(10), the Account to eliminate the margin term ‘‘Initial Margin Deficit’’ would be defined as be required for a margin account that deficiency. the amount, if any, by which (A) the sum of the • Proposed FINRA Rule 4240(b)(4)(D) would be the economic equivalent of Value of the Initial Margin in an Uncleared SBS such SBS. However, other types of Account and the Counterparty’s Rule 4210 Excess would require a member to net the SBS—including CDS and equity TRS is less than (B) the Initial Margin Requirement for the Uncleared SBS Account. A person’s ‘‘Rule 4210 a guarantee), proposed FINRA Rule 4240(b)(3)(C) with complex features—may not be Excess’’ would be defined in proposed FINRA Rule would also require a member to collect both easily accommodated under these 4240(d)(15) to mean the amount, if any, by which Variation Margin and Initial Margin from the party frameworks, and the specific risks that the equity (as defined in FINRA Rule 4210(a)(5)) in that has obligations under the Uncleared SBS for accompany such SBS may not be readily the Counterparty’s margin account at the member which the member has responsibility, to the extent exceeds the amount required by FINRA Rule 4210. that such collection would be required if the apparent or quantifiable to FINRA 119 To account for situations where a member is member were a party to the Uncleared SBS, unless without additional information. not the actual party to an SBS, but nonetheless has the member can establish that such margin has been Moreover, as noted above SBS can be financial exposure for Uncleared SBS (e.g., through delivered to the other party.

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delivery or return of Variation Margin Exposure and the Initial Margin follow Exchange Act Rule 18a–3 by against the collection of Initial Margin, Requirement, provided that the member providing an exception for Multilateral if applicable, and would further permit collects and delivers margin on Legacy Organizations and requiring the risk a member to net the return of Initial SBS to the extent of its contractual posed by such SBS to be accounted for Margin against the collection or retrieval rights and obligations to do so.120 in a member’s capital computations. of Variation Margin, if applicable. However, a member would be required • Financial Market Intermediaries. A • Proposed FINRA Rule 4240(b)(4)(E) to take a capital deduction under member would not be required to would prohibit a member from Exchange Act Rule 15c3–1 or, if collect Initial Margin from a returning Initial Margin to a applicable, FINRA Rule 4110(a), to Counterparty that is a Financial Market Counterparty, or permitting a reflect the amount of any margin that it Intermediary (but would still be Counterparty to make a withdrawal would have otherwise been required to required to collect or deliver Variation from the Counterparty’s margin account, collect if the Legacy SBS had been Margin, as applicable).122 In such case, if doing so would create or increase an included in the Counterparty’s a member would be required to take a Initial Margin Deficit. Uncleared SBS Account. FINRA capital deduction to reflect the amount FINRA believes it is appropriate and believes it is appropriate to provide a of any Initial Margin that it would have consistent with the protection of general exception for legacy SBS, as otherwise been required to collect from member firms and investors to require members would not be in a position to such Financial Market Intermediary. A margin for uncleared SBS to be require their counterparties to legacy Counterparty that is a Financial Market delivered or collected, as applicable, on SBS to exchange margin under existing Intermediary generally would be subject a T+1 basis, and to further require that SBS agreements as would otherwise be to a comprehensive regulatory uncleared SBS positions be liquidated if required under proposed FINRA Rule framework, including capital margin is not collected within a T+3 4240. However, in such cases FINRA requirements. FINRA therefore believes timeframe. FINRA also believes the believe it is appropriate to require a it is appropriate to account for the other clarifications described above are member to take a corresponding capital reduced counterparty credit risk posed necessary to ensure that members and charge to account for the member’s by such Counterparties by permitting a their uncleared SBS counterparties have ongoing risk exposure under such SBS. member to take a capital charge in lieu a clear and consistent understanding of • Multilateral Organizations. A of requiring such Counterparties to post when and how margin must be member would not be required to Initial Margin. However, FINRA delivered or collected under the deliver Variation Margin to, or collect continues to believe that Variation proposed rule change. Initial Margin or Variation Margin from, Margin should be exchanged with such Proposed FINRA Rule 4240(b)(5), any Multilateral Organization.121 Counterparties to account for ongoing entitled ‘‘Exceptions,’’ would provide However, a member would be required the market risk posed by such uncleared eight specific exceptions from a to take a capital deduction to reflect the SBS. member’s general obligation to collect or amount of any margin that it would • Sovereign Counterparties. A deliver margin, as applicable, under otherwise have been required to collect member would generally be required to proposed FINRA Rule 4240(b)(3), from such a Multilateral Organization. deliver Variation Margin to, and collect described above. FINRA believes the FINRA believes it is appropriate to Initial Margin or Variation Margin from, proposed exceptions would further a Sovereign Counterparty.123 However, align the requirements of proposed 120 Under proposed FINRA Rule 4240(d)(12), a under proposed FINRA Rule FINRA Rule 4240 with the margin ‘‘Legacy SBS’’ would be defined as an Uncleared 4240(b)(5)(E), if the member has requirements applicable to SBSDs under SBS entered into before October 6, 2021. Proposed determined pursuant to policies and FINRA Rule 4240(b)(2)(A)(iv) would also clarify Exchange Act Rule 18a–3 and provide that for any Legacy SBS for which proposed Rule procedures or credit risk models members with additional flexibility in 4240 does not specify an Initial Margin established pursuant to Exchange Act managing their risk exposures, while Requirement (i.e., an SBS other than a Basic CDS, Rule 15c3–1(c)(2)(vi)(l) that the still ensuring that the risks to members Basic SBS or other SBS for which FINRA has Sovereign Counterparty has only a approved specific margin requirements), the Initial with respect to their uncleared SBS Margin Requirement must be calculated using the minimal amount of credit risk, the exposures are adequately addressed. applicable method specified in Exchange Act Rule member would not be required to The proposed exceptions under FINRA 15c3–1(c)(2)(vi)(P). The Initial Margin Requirement collect Initial Margin from such Rule 4240(b)(5) would include the for Legacy SBS calculated under this provision Sovereign Counterparty (but would still following: would be used for purposes of determining the be required to collect or deliver • appropriate corresponding capital charge, as well as Clearing Agencies. A member to determine the Initial Margin Requirement for a Variation Margin, as applicable). In such would not be required to deliver Legacy SBS to the extent that a member elects not case, a member would be required to Variation Margin to, or collect Initial to utilize the Legacy SBS exception under proposed take a capital deduction to reflect the Margin or Variation Margin from, any FINRA Rule 4240(b)(5). amount of any Initial Margin that it 121 Under proposed FINRA Rule 4240(d)(13), a Clearing Agency, and would also not be ‘‘Multilateral Organization’’ would be defined to would have otherwise been required to required to deduct otherwise required mean the Bank for International Settlements, the collect from such Sovereign Variation Margin or Initial Margin in the European Stability Mechanism, the International Counterparty. As for Financial Market computation of its net capital under Bank for Reconstruction and Development, the Intermediaries, FINRA believes it is Multilateral Investment Guarantee Agency, the Exchange Act Rule 15c3–1 or, if International Finance Corporation, the Inter- appropriate to account for the reduced applicable, FINRA Rule 4110(a). FINRA American Development Bank, the Asian believes this exception is consistent Development Bank, the African Development Bank, 122 Under proposed FINRA Rule 4240(d)(8), a with its determination to defer to the European Bank for Reconstruction and ‘‘Financial Market Intermediary’’ would be defined Development, the European Investment Bank, the to mean an SBSD, swap dealer, broker or dealer, Clearing Agency margin requirements European Investment Fund, the Nordic Investment FCM, bank, foreign bank, or foreign broker or with respect to Cleared SBS. Bank, the Caribbean Development Bank, the Islamic dealer. • Legacy SBS. A member would be Development Bank, the Council of Europe 123 Under proposed FINRA Rule 4240(d)(17), a permitted to omit all (but not less than Development Bank, or any other multilateral ‘‘Sovereign Counterparty’’ would be defined as a all) Legacy SBS with a Counterparty development bank that provides financing for Counterparty that is a central government national or regional development in which the U.S. (including the U.S. government) or an agency, from the Counterparty’s Uncleared SBS government is a shareholder or contributing department, ministry or central bank of a central Account when computing Current member. government.

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counterparty credit risk posted by with Exchange Act Rule 15c3–1e(c).125 exposures based on a broader view of highly creditworthy Sovereign FINRA believes that the proposed their overall relationship with a Counterparties by permitting a member exception from the Initial Margin particular Counterparty. FINRA believes to take a capital charge in lieu of Requirements for uncleared SBS with it is appropriate to provide an exception requiring such Counterparties to post Majority Owners, provided that the from proposed FINRA Rule 4240 for any Initial Margin. However, FINRA member takes a capital charge in lieu of SBS in a portfolio margin account if the continues to believe that Variation collecting Initial Margin, would SBS is of a type whose risk is Margin should be exchanged with such adequately protect members in such appropriately addressed by an approved Counterparties to account for ongoing circumstances due to the lower risk theoretical pricing model (e.g., TIMS) the market risk posed by such uncleared presented by Majority Owners, which and covered by portfolio risk SBS. typically must satisfy capital and other management procedures filed by the • Majority Owners; ANC Firms requirements applicable to bank holding member with FINRA, as well as for SBS Transacting with Majority Owners or companies and similar entities. FINRA permitted by the SEC to be portfolio Registered or Foreign SBS Dealers also believes that the proposed margined in a commodity account. In Under Common Ownership. FINRA exception for ANC Firms with respect to these circumstances, the risks presented understands that members may enter SBS with Majority Owners and by such SBS would already be subject into uncleared SBS with affiliated Registered or Foreign SBS Dealer to a comprehensive risk management entities for a variety of reasons, affiliates, provided that the member framework, and therefore FINRA does including for risk management takes a corresponding credit risk charge, not believe it necessary to apply the purposes. FINRA does not believe a would adequately protect such members proposed new margin requirements to broad exception from the proposed while reducing potential competitive such SBS. margin requirements for uncleared SBS disparity as between ANC Firms that are Proposed FINRA Rule 4240(c), with all affiliates would adequately registered SBSDs (and therefore subject entitled ‘‘Risk Monitoring Procedures account for the risks posed to its to Exchange Act Rule 18a–3) and ANC and Guidelines,’’ would require members by uncleared SBS in such Firms that are not registered SBSDs (and members to monitor the risk of any circumstances. However, FINRA does therefore would be subject to proposed Uncleared SBS Accounts and maintain believe that two specific, more limited FINRA Rule 4240 with respect to their a comprehensive risk analysis exceptions for SBS entered into with uncleared SBS). methodology for assessing the potential certain affiliates would be appropriate. • Portfolio Margin. Proposed FINRA risk to the member’s capital over a First, under proposed FINRA Rule Rule 4240(b)(5)(H) would provide that specified range of possible market 4240(b)(5)(F), a member would not be proposed FINRA Rule 4240 would not movements over a specified time period. required to collect Initial Margin from a apply to any unlisted derivative, as For purposes of this requirement, Counterparty that is a direct or indirect defined in FINRA Rule 4120(g)(2)(H), members would be required to employ owner of a majority of the equity and carried by the member in a portfolio the following risk monitoring voting interests in the member (a margin account subject to the procedures and guidelines: ‘‘Majority Owner’’) (but would still be requirements of FINRA Rule 4210(g) if • Obtaining and reviewing the required to collect or deliver Variation such unlisted derivative is of a type required documentation and financial Margin, as applicable). In such case, a addressed in the comprehensive written information necessary for assessing the member would be required to take a risk analysis methodology filed by the amount of credit to be extended to SBS capital deduction to reflect the amount member with FINRA in accordance with Counterparties; of any Initial Margin that it would have FINRA Rule 4210(g)(1).126 In addition, • otherwise been required to collect from determining and documenting the proposed FINRA Rule 4240 would not such Majority Owner. Second, under legal enforceability of netting or apply to any SBS carried in a proposed FINRA Rule 4240(b)(5)(G), a collateral agreements, including commodity account or other account member that is an ANC Firm would not enforceability in the event a under the jurisdiction of the CFTC in be required to collect Initial Margin Counterparty becomes subject to accordance with an SEC rule, order or from a Counterparty that is a Majority bankruptcy or other insolvency no-action letter permitting SBS and Owner or a Registered or Foreign SBS proceedings; swaps to be carried and portfolio • Dealer under common ownership (but assessing the determination, review would still be required to collect or margined together in such an account. and approval of credit limits to each deliver Variation Margin, as Portfolio margining provides members Counterparty, and across all applicable).124 In such case, an ANC with the flexibility to manage their risk Counterparties; • Firm member would be required to take monitoring credit risk exposure to 125 FINRA notes that an ANC Firm transacting the member from SBS, including the a deduction for credit risk on such with a Counterparty that is its Majority Owner transactions computed in accordance would also benefit from the general exception for type, scope and frequency of reporting collecting Initial Margin from Majority Owners, to senior management; • 124 Under proposed FINRA Rule 4240(d)(14), a described above. However, under this additional the use of stress testing of accounts ‘‘Registered or Foreign SBS Dealer’’ would be exception, an ANC Firm would be permitted to take containing SBS contracts in order to defined to mean (i) any person registered with the only a deduction for the credit risk on its monitor market risk exposure from SEC as an SBSD or (ii) any foreign person if the SEC transactions with Majority Owner counterparties as has made a substituted compliance determination calculated in accordance with Exchange Act Rule individual accounts and in the under Exchange Act Rule 3a71–6(a)(1) that 15c3–1e, rather than the full amount of the Initial aggregate; compliance by a SBSD or class thereof with Margin Requirement that would otherwise have • managing the impact of credit specified requirements of a foreign regulatory applied. extended related to SBS contracts on the system that are applicable to such foreign person 126 FINRA is also proposing a technical may satisfy the capital requirements of Section adjustment to the definition of ‘‘unlisted member’s overall risk exposure; 15F(e) of the Act and Exchange Act Rule 18a–1 that derivative’’ under FINRA Rule 4210(g)(2)(H) to • determining the need to collect would otherwise apply to such SBSD or class clarify that, to qualify under the definition, the additional margin from a particular thereof. Therefore, the definition would cover option, forward contract or SBS must be able to be customer or broker or dealer, including registered SBSDs and entities that are subject to valued by a theoretical pricing model that is equivalent SBSD capital requirements in a foreign approved by the SEC for valuing that type of whether that determination was based jurisdiction. options, forward contract or SBS. upon the creditworthiness of the

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customer or broker or dealer and/or the respect to their uncleared SBS serve to protect investors and the public risk of the specific contracts; transactions under Exchange Act Rule interest. • determining the need for higher 18a–3.127 These requirements are also Finally, the proposed rule change will margin requirements than required by based in part on aspects of FINRA Rule also protect investors and the public proposed FINRA Rule 4240 and 4210, including procedures related to interest by establishing a new margin formulating the member’s own margin the need for additional margin under rule for SBS applicable to members that requirements, including procedures for FINRA Rule 4210(d) and the portfolio are not registered SBSDs. FINRA identifying unusually volatile positions, margin risk monitoring requirements believes that the proposed rule change concentrated positions (with a under FINRA Rule 4210(g)(1). SBS are will thereby fill an important regulatory particular Counterparty and across all complex financial instruments that may gap, protect members against Counterparties and customers), or expose a member to significant risks, counterparty credit risk, maintain a positions that cannot be liquidated including, for example, market risk, level playing field for members and promptly; counterparty credit risk, operational risk prevent regulatory arbitrage. • monitoring the credit exposure and legal risk. FINRA accordingly resulting from concentrated positions B. Self-Regulatory Organization’s believes it is appropriate and necessary, Statement on Burden on Competition with a single Counterparty and across and consistent with the protection of all Counterparties, and during periods investors, for members with exposure to FINRA does not believe that the of extreme volatility; proposed rule change will result in any • uncleared SBS to maintain a identifying any Uncleared SBS comprehensive risk monitoring burden on competition that is not Accounts with intraday risk exposures program, including the specific necessary or appropriate in furtherance that are not reflected in their end of day elements described above, to address of the purposes of the Act. positions (e.g., Uncleared SBS Accounts such risks. that frequently establish positions and Economic Impact Assessment then trade out of, or hedge, those If the Commission approves the FINRA has undertaken an economic positions by the end of the day) and proposed rule change, the effective date impact assessment, as set forth below, to collecting appropriate margin to address of the proposed rule change will be analyze the regulatory need for the those intraday risk exposures; October 6, 2021. proposed rule change, its potential • identifying any Uncleared SBS 2. Statutory Basis economic impacts (including Account that, in light of current market anticipated costs, benefits, and conditions, could not be promptly FINRA believes that the proposed rule distributional and competitive effects, liquidated for an amount corresponding change is consistent with the provisions relative to the current baseline) and the 128 to the Current Exposure computed with of Section 15A(b)(6) of the Act, alternatives considered in assessing how respect to such account and determining which requires, among other things, that best to meet FINRA’s regulatory the need for higher margin requirements FINRA rules must be designed to objective. on such accounts or the positions prevent fraudulent and manipulative 1. Regulatory Need therein; acts and practices, to promote just and • maintaining sufficient Initial equitable principles of trade, and, in As detailed above, the SEC has Margin in the accounts of each general, to protect investors and the adopted final rules under Title VII of the Counterparty to protect against the public interest. FINRA believes that, by Dodd-Frank Act implementing the new largest individual potential future affirmatively addressing the treatment of regulatory framework for SBS, including exposure of an Uncleared SBS in such SBS under FINRA rules, the proposed rules requiring SBS Entities to register Counterparty’s Uncleared SBS Account, rule change will serve to promote with the SEC, business conduct and as measured by computing the largest regulatory clarity and consistency. supervision requirements, risk maximum possible loss that could result FINRA also believes that this aspect of mitigation techniques, and margin, from the exposure; and the proposed rule change is consistent capital and segregation requirements for • increasing the frequency of with Congress’s intent to define SBS as SBS Entities, among many other calculations of Current Exposure and securities under the Act and its detailed requirements. For SBS Entities, Initial Margin Requirements during underlying regulations, and that such the compliance date for the SEC’s key periods of extreme volatility and for treatment will enhance investor SBS requirements will be October 6, accounts with concentrated positions. protection. FINRA further believes that, 2021, and the deadline for the first wave Proposed FINRA Rule 4240(c) would by providing limited exceptions from of SBS Entities to register is November further require a member to review, in the application of FINRA rules to SBS, 1, 2021. FINRA currently has in place a accordance with the member’s written the proposed rule change will promote temporary, broad exception from the procedures, at reasonable periodic legal certainty, provide clarity regarding application of its rules to its members’ intervals, the member’s SBS activities the application of its rules and avoid SBS activities and positions, which will for consistency with these risk unnecessary regulatory duplication. expire on September 1, 2021. In light of monitoring procedures and guidelines, The proposed rule change will also the upcoming Registration Compliance and to determine whether the data promote regulatory consistency by Date, FINRA is proposing to amend its necessary to apply the risk monitoring conforming FINRA’s capital-related rules as detailed above to clarify the procedures and guidelines is accessible requirements to the SEC’s amended net application of its rules to SBS and take on a timely basis and information capital rule. FINRA also believes that, into account member’s SBS activities systems are available to adequately by applying higher financial once SBS Entities begin registering with capture, monitor, analyze and report responsibility and operational standards the SEC. relevant data. to members with financial exposure to 2. Economic Baseline The risk monitoring procedures and SBS, the proposed rule change will guidelines under proposed FINRA Rule The economic baseline for the 4240(c) are similar to the risk 127 See 17 CFR 240.18a–3(e); Capital, Margin, and proposed rule change is based on the monitoring and procedure requirements Segregation Release, supra note 8, at 43930. relevant existing regulatory framework, applicable to nonbank SBSDs with 128 15 U.S.C. 78o–3(b)(6). existing firm practices and information

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collected through outreach efforts. purposes,129 and rely on existing margin firms engaging in SBS activities under FINRA believes that the proposed rule collection and governance systems and the de minimis threshold for SBSD change should be evaluated against a infrastructure. registration, and firms engaging in SBS baseline where the SEC’s new rules for FINRA has also engaged with other activities in other capacities (e.g., risk SBS have come into effect and FINRA’s relevant regulators, including the SEC, management). As discussed above, existing exceptions have expired—i.e., if the CFTC and the National Futures based on existing information, FINRA current FINRA Rule 0180 were to expire Association (‘‘NFA’’). Through these understands that the number of such as scheduled on September 1, 2021 and efforts, FINRA has gained further insight member firms is small and concentrated new FINRA Rule 0180 not adopted as into the application of the SEC’s SBS among larger member firms. The proposed—as well as applying FINRA’s rules to its member firms, as well as the proposed rule change is expected to existing margin and financial similarities and differences between the reduce regulatory arbitrage and establish operational rules and requirements to SEC and CFTC regulatory frameworks. a regulatory framework for FINRA SBS without the proposed changes Furthermore, FINRA gathered further member firms that wish to engage in described above. Under this baseline, all information about the approach taken SBS activities, without diminishing member firms contemplating offering by the NFA for regulating the activities investor protections. of FCMs and other registrants engaged SBS services to clients would be subject A. Anticipated Benefits to FINRA’s applicable rules with regard in swap activities. For example, FINRA FINRA believes that the proposed rule to business conduct requirements, notes that an FCM generally does not need to comply with NFA rules specific change would benefit member firms by financial responsibility and operational to swaps (e.g., margin) unless it is also reducing regulatory uncertainty, requirements, and margin. As discussed a registered swap dealer. Finally, FINRA unnecessary regulatory duplication and above, these rules as applied to SBS discussed the implications of member the potential for arbitrage with the SEC’s Entities, may in some cases be firms engaging in SBS activities under regulatory framework for SBSDs that are duplicative of SEC rules, and thus may Exchange Act Rule 15a–6.130 not FINRA member firms. Furthermore, impose unnecessary material obligations In parallel to the outreach efforts FINRA believes that the proposed rule given the firms’ activities in the space, conducted through engagement with change would alleviate some of the could result in operational difficulties individual member firms, as discussed potential competitive disadvantages for or be insufficient to provide appropriate above, FINRA posted on its public FINRA member firms that wish to risk controls. Under this scenario, some website an open-ended request for engage in SBS activities without member firms may choose to limit or feedback on how FINRA rules should be registering as SBSDs. FINRA believes not provide SBS services, which may applied to SBS and invited interested this goal is achievable through the result in decreased choice and increased parties to submit views and information increased regulatory clarity resulting costs to customers. via a dedicated email box.131 The from the proposed rule change. Finally, Through outreach efforts and responses received largely echoed FINRA believes that the combination of discussions with individual member FINRA’s discussion with member firms. these accrued benefits could incentivize firms, FINRA has learned about current In addition, FINRA issued Regulatory member firms to engage in SBS member firm SBS activities and their Notice 20–36 to solicit further comment activities. This could lead to an increase preparations for the Registration on the proposal, including any potential in consumer choice, and potentially Compliance Date. The majority of economic impacts.132 As discussed in increase member firms’ ability to member firms that participated in the Item II. C. of this filing, FINRA received compete in SBS products. outreach efforts indicated that they one comment letter in response to A primary benefit of the proposed intend to register a bank affiliate, foreign Regulatory Notice 20–36. rule change is that it permits firms that are registered with the SEC to rely on affiliate or stand-alone dealer affiliate as 3. Economic Impacts the SBSD. Some of the firms indicated relevant SEC rules governing business FINRA has analyzed the potential some involvement in SBS activities on conduct requirements with respect to costs and benefits of the proposed rule their SBS activities. In so doing, the the part of their FINRA-registered change, and the different parties that are proposed rule change ensures that there associated persons, but typically in the expected to be affected. FINRA has would be no unintended differences person’s capacity as an associated identified member firms that engage in between the firms’ obligations under person of the affiliated SBSD. Firms SBS activities and their customers as the SEC and FINRA rules and would further indicated that their SBS parties that would primarily be affected impose no additional direct or indirect activities will be focused on their by the proposed rule change. In costs to firms that are registered SBSDs existing trading programs related to particular, these include member firms engaging in SBS activities. The CDS, equity index and single-name TRS, that will register as SBSDs, firms proposed rule change is also expected to and asset-backed security swaps. FINRA seeking to broker SBS transactions, reduce potential regulatory arbitrage also solicited input from member firms across the relevant regulatory that may conduct an SBS business 129 The SIMM is a methodology proposed by frameworks of FINRA, the SEC and the below the SEC’s registration thresholds. ISDA to help market participants calculate initial CFTC. Increased consistency across Generally, FINRA has found that the margin on non-cleared derivatives under the framework developed by the Basel Committee on regulatory frameworks would benefit number of member firms that are Banking Supervision and the International member firms seeking to engage in SBS planning to register as an SBSD, or Organization of Securities Commissions. See ISDA, activities through multiple affiliates and engage in SBS activities below the SEC’s Standard Initial Margin Model for Non-Cleared those firms engaging in an SBS business registration thresholds, is small and Derivatives (December 2013), https://www.isda.org/ a/cgDDE/simm-for-non-cleared-20131210.pdf. without registering with the SEC. concentrated in larger firms. FINRA also 130 Exchange Act Rule 15a–6 provides conditional Member firms would be expected to discussed with firms their practices exemptions from registration under the Exchange be able to use their existing governance with respect to margin practices for SBS Act that permit non-US broker-dealers to engage in and compliance systems and transactions. Most firms reported they certain activities in the US or with US persons without having to register with the SEC. procedures, including in situations would be using the standard initial 131 See supra note 25. where member firms will have dual- margin model (‘‘SIMM’’) for margin 132 See supra note 26. hatted personnel or have an affiliate that

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is registered with the CFTC as a swaps can be either near-term costs, stemming identified as engaged in such activities, dealer. Finally, member firms are from FINRA’s decision to provide the extent of such potential competitive expected to benefit from the proposed exceptions for certain rules but not impacts and outcomes is unclear. exception for current rules that others, or long-term costs, if trading in Moreover, FINRA believes that such otherwise might otherwise apply but are SBS evolves in ways that would require competitive impacts would depend on a not feasible or appropriate in the a reconsideration of the exceptions. firm’s interest in, and the scope of, its context of SBS activities. This will Some costs are also expected to stem SBS activities. reduce operational and compliance from the proposal to treat member firms costs for firms without diminishing with financial exposure to SBS the same 4. Alternatives Considered investor protections. Similarly, with as carrying or clearing firms for FINRA has considered various respect to financial responsibility and purposes of FINRA’s financial and alternatives to the proposed rule change. operational requirements, the proposed operational rules. However, FINRA For example, FINRA considered an rule change would benefit member firms believes that the majority of member option to allow current FINRA Rule by aligning FINRA rules with SEC rules, firms that will be engaged in SBS 0180 to expire without replacing it with thus reducing the costs and risks of activities already qualify as carrying or a new rule. This would result in no regulatory arbitrage. clearing firms under these rules. Thus, exceptions from the applications of the With respect to margin requirements, it is expected that any incurred FINRA rules to member firms engaging the proposed rule change also seeks to compliance costs resulting from this in SBS activities. A different alternative rely on the SEC’s rules and framework proposed requirement would be that considered would be to delete the to provide consistent protections and minimal. Further, for member firms not expiration date from current FINRA regulatory requirements. First, member registering as SBSDs, the proposal to Rule 0180 and rely solely on the SEC’s firms that register as SBSDs would be align FINRA’s regulatory notification SBS regulatory framework going exempted from the FINRA margin and business curtailment rule forward. FINRA considered similar requirements, thus eliminating any requirements to the SEC’s amended net alternatives with respect to the regulatory burden that might arise from capital rule may result in increased proposed margin requirements and a different approach. Second, for other associated costs. amendments to its financial firms, the margin requirements for The proposed margin requirements responsibility and operational rules. uncleared Basic CDS would conform may impose some costs on member FINRA believes that the proposed rule with the standard SEC margin firms seeking to engage in SBS activities change strikes an appropriate balance requirements, thus reducing risk of without registering as SBSDs. The new among establishing a regulatory regulatory arbitrage. Third, the proposal margin requirements would require framework for SBS activities, regulatory is expected to benefit member firms by such member firms engaged in SBS burdens and investor protection providing additional mitigation of activities to have comprehensive written considerations. counterparty risks for SBS-related credit risk management procedures activities that fall outside of the SEC appropriate for the business and to C. Self-Regulatory Organization’s regulatory framework. Fourth, the ensure compliance with them. Statement on Comments on the margin requirements are expected to Moreover, additional costs would arise Proposed Rule Change Received From enhance member firms’ ability to from allowing firms to take a capital Members, Participants, or Others compete in these products. Fifth, charge in lieu of margin, where replacing the current FINRA Rule 4240, permitted. These costs are associated A concept proposal summarizing the which by its terms is a temporary rule, with managing capital accounts, related proposed rule change was published for with an ongoing rule would reduce compliance costs, and any opportunity comment in Regulatory Notice 20–36 regulatory uncertainty and benefit firms costs that might arise from committing (October 2020).133 One comment was with respect to compliance systems and capital. FINRA notes that firms would received in response to the Regulatory associated costs. Finally, FINRA be permitted to take this approach and Notice.134 The comment letter is believes that the anticipated benefits of thus would only be anticipated to do so summarized below. the proposed margin requirements in instances where the costs are lower SIFMA expressed overall support for might accrue to counterparties, than the alternative margin many aspects of the Concept Proposal, customers and the financial system as a requirements. but suggested further tailoring to seek whole, as it decreases the chance of FINRA recognizes that the proposal greater clarity regarding the application unexpected firm failure and dampens should be considered relative to of FINRA rules to SBS, ensure that shock transmission. alternative regulatory regimes available standalone broker-dealers are not placed to member firms and their affiliates. at a disadvantage to broker-dealers that B. Anticipated Costs Firms will consider whether the costs are also registered as SBSDs, and better FINRA believes that the proposed rule and benefits of providing SBS services harmonize certain FINRA rules with the change would result in some direct are most efficient under these proposed SEC’s SBS Entity rules.135 In the costs to member firms that choose to rules, alternative domestic rules, such as Concept Proposal, FINRA noted that it engage in SBS activities in various those of the CFTC, or through a foreign was considering extending its existing capacities. In particular, member firms entity. FINRA has considered the exceptions under current FINRA Rule would be required to develop a potential impacts of the proposal on 0180 until the Registration Compliance regulatory compliance program for SBS competition among financial service activities and monitor for their providers and how that competition 133 See Regulatory Notice 20–36 (October 2020) compliance. may limit investor choice or impose (‘‘Concept Proposal’’). FINRA believes that the proposed rule higher, or additional, risks or costs to 134 See Letter from Kyle L Brandon, Managing change’s exceptions from applying some investors. FINRA sought information Director, Head of Derivatives Policy, Securities of its rules to SBS activities benefits and comments on this specific issue in Industry and Financial Markets Association (‘‘SIFMA’’), to Jennifer Piorko Mitchell, Office of member firms. However, such Regulatory Notice 20–36. FINRA the Corporate Secretary, FINRA, dated November exceptions could potentially further believes that given the current set of 16, 2020 (‘‘SIFMA Letter’’). result in costs to member firms. These SBS activities, and member firms 135 See SIFMA Letter at 1.

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Date on October 6, 2021.136 SIFMA The proposed rule change would requested that FINRA confirm that, by noted that, per the SEC Transitional provide such exceptions under adopting these exceptions and applying Period Guidance, most, if not all, SBSDs proposed FINRA Rule 0180(b). such exceptions to dual-hatted will wait to register until November 1, In the Concept Proposal, FINRA individuals, FINRA is not addressing 2021, and therefore SIFMA stated that it was considering providing whether or to what extent the rules not recommended that FINRA instead exceptions from the presumption of covered by these exceptions might extend the expiration date of current applicability of FINRA rules to SBS for apply to dual-hatted personnel when FINRA Rule 0180 until November 1, certain business conduct rules that are acting in their capacity as associated 2021.137 After consideration, FINRA similar to the SEC’s new SBS Entity persons of an affiliated entity. Second, believes that the Registration rules. Specifically, FINRA stated its SIFMA requested that FINRA confirm Compliance Date is the most preliminary belief that it would be that regardless of how the dual-hatting appropriate date to implement the appropriate to permit an SBS Entity that arrangement is documented, if in proposed rule change in order to align is a FINRA member and an associated substance the relevant individual is with the implementation of the SEC’s person of an SBS Entity who is acting designated as an associated person of an Title VII rulemakings and avoid in his or her capacity as an associated SBS Entity and is in fact acting in that unnecessary confusion. FINRA also person of an SBS Entity to comply with capacity, then such individual would understands that existing, temporary the parallel SEC requirements in lieu of benefit from FINRA’s proposed exemptions from some SEC rules expire the similar FINRA Rules.141 FINRA exceptions.145 FINRA has addressed on the Registration Compliance Date, noted the following rules in particular: both aspects of SIFMA’s request relating and that SBSDs are likely to register on (1) FINRA Rule 2030 (Engaging in to dual-hatted personnel above.146 that date to align with the expiration of Distribution and Solicitation Activities Second, in the Concept Proposal, those exemptions. Therefore, as with Government Entities); (2) FINRA FINRA noted the SEC’s cross-border discussed above, FINRA intends to Rule 2090 (Know Your Customer); (3) counting exception under Exchange Act extend the expiration date of current FINRA Rule 2111 (Suitability); (4) Rule 3a71–3(d) and stated that it was FINRA Rule 0180, as well as the interim FINRA Rule 2210(d) (Communications considering also providing an exception CDS margin pilot program under current with the Public—Content Standards); (5) for members acting in compliance with FINRA Rule 4240, to the Registration FINRA Rule 2232 (Customer that exception from the FINRA rules Compliance Date on October 6, 2021.138 Confirmations); and (6) FINRA Rules that are parallel to the SEC’s SBS Entity In the Concept Proposal, FINRA 3110 (Supervision), 3120 (Supervisory rules that are conditions of the stated that it was considering providing Control System) and 3130 (Annual exception.147 SIFMA expressed support general exceptions from the Certification of Compliance and for this additional exception and presumption of applicability of FINRA Supervisory Processes). SIFMA requested that FINRA expand its rules to SBS for certain rules that were expressed general support for this exceptions for FINRA Rules 2111 intended for other types of securities aspect of the Concept Proposal, noting (Suitability), 2210(d) (Communications and could create operational difficulties FINRA’s observation that these rules with the Public—Content Standards) if applied to SBS.139 SIFMA supported would unnecessarily duplicate certain and 2232 (Customer Confirmations) to FINRA’s proposal to except these rules of the SEC’s SBS Entity rules if they cover a FINRA member when it is acting from the general presumption of applied to SBS Entities or their as the registered entity for a foreign applicability, including the FINRA Rule associated persons.142 However, SIFMA affiliate pursuant to Exchange Act Rule 6000 Series (Quotation, Order, and made four recommendations for FINRA 3a71–3(d).148 As discussed above, the Transaction Reporting Facilities), the to make certain clarifications and proposed rule change would include FINRA Rule 7000 Series (Clearing, expand the proposed exceptions. The these exceptions in proposed FINRA Transaction and Order Data proposed rule change would provide Rule 0180(e). Requirements, and Facility Charges) and these exceptions in proposed FINRA Third, SIFMA requested that FINRA the FINRA Rule 11000 Series (Uniform Rules 0180(c) and (d), with certain also adopt exceptions from associated Practice Code). SIFMA stated that modifications as noted below.143 person registration and CE requirements providing exceptions for these rules will First, in the Concept Proposal, FINRA in FINRA Rules 1210, 1220 and 1240 for promote clarity, considering that these stated that the proposed exceptions a person associated with a broker-dealer rules are not designed to apply to SBS would apply both where the member dually registered as an SBS Entity and arguable overlap with some of the itself is registered as an SBS Entity and whose securities-related activities relate SEC’s rules such as Regulation SBSR.140 where the associated person of the solely and exclusively to transactions in member is ‘‘dual-hatted’’ as an SBS conducted in his or her capacity as 136 See Concept Proposal at 3. associated person of an affiliated SBS an associated person of an SBS 144 137 See SIFMA Letter at 1–2; see also supra note Entity. SIFMA requested that FINRA Entity.149 SIFMA noted that FINRA’s 10. clarify the treatment of dual-hatted existing registration, proficiency testing 138 See supra note 18. personnel under these proposed and CE requirements are not tailored to 139 See Concept Proposal at 4. exceptions in two respects. First, SIFMA 140 See SIFMA Letter at 2. SIFMA also noted that SBS and it would therefore seem to the Concept Proposal also stated FINRA’s provide little, if any, benefit to apply to public appearances. FINRA believes these preliminary intention to provide a general requirements should apply to communications those requirements to such associated exception from FINRA Rule 2210, other than the relating to SBS to the extent the rule otherwise persons. In this regard, SIFMA noted content standards in paragraph (d). See id. at 2 n.3. applies to the communication. After further consideration, FINRA does not believe that similar considerations led the NFA 141 a general exception from the remainder of FINRA See Concept Proposal at 4–5. initially to exclude swaps associated Rule 2210 is appropriate, and therefore the 142 See SIFMA Letter at 2. persons from its proficiency testing proposed rule change does not provide this 143 In addition to the modifications described exception under proposed FINRA Rule 0180(b). The above in response to SIFMA’s feedback, the 145 See SIFMA Letter at 3. remainder of FINRA Rule 2210 includes specified proposed rule change also splits these exceptions 146 principal approval, review, filing and into two paragraphs of proposed FINRA Rule 0180 See supra note 38. recordkeeping requirements applicable to certain to account for SEC rules that apply to only SBSDs 147 See Concept Proposal at 16 n.14. types of communications, as well as limitations on rather than all SBS Entities. See supra note 36. 148 See SIFMA Letter at 3–4. the use of FINRA’s name and standards applicable 144 See Concept Proposal at 4. 149 See SIFMA Letter at 4.

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requirements until tests tailored to disputes.153 SIFMA also noted that the in SBS, including for risk management swaps could be developed. SIFMA also SEC’s amended recordkeeping rules, purposes. SIFMA therefore suggested stated that associated persons of specifically Exchange Act Rule 17a– that FINRA allow a member subject to standalone SBSDs are not subject to 3(a)(9)(iv), cover much of the the proposed new rule to opt into registration or CE requirements and, information required by FINRA Rule compliance with Exchange Act Rule since SBSDs generally are not required 4512, and that such rules are 18a–3 if the member (a) is affiliated with to register as broker-dealers or become specifically tailored to SBS while a registered SBSD subject to Exchange FINRA members, it would be FINRA Rule 4512 requires information Act Rule 18a–3 and (b) uses initial inappropriate to subject associated that is unlikely to be relevant to SBS.154 margin models, if any, that the SEC has persons of SBSDs to differing FINRA believes that limited exceptions approved for use by that affiliate.157 requirements solely depending on along the lines requested by SIFMA are FINRA acknowledges that proposed whether the SBSD happened, for other appropriate where an account solely new FINRA Rule 4240 would diverge reasons, to be a FINRA member.150 holds SBS and related collateral for a from Exchange Act Rule 18a–3 in some FINRA believes that an exception along counterparty to a member that is acting respects, which FINRA believes are the lines requested by SIFMA is in its capacity as an SBS Entity. important to protect its members given appropriate, at least until such time as Accordingly, as discussed above, the that members subject to the rule would proposed rule change includes proposed not be subject to the comprehensive FINRA may develop registration, FINRA Rule 0180(f), which would regulatory framework applicable to licensing and CE requirements tailored provide that FINRA Rules 2231 and SBSDs. For example, registered SBSDs to SBS. As discussed above, the 4512 shall not apply to members’ are subject to higher minimum capital proposed rule change therefore includes activities and positions with respect to requirements, and the SEC’s margin proposed FINRA Rule 0180(g), which SBS, to the extent that the member is requirements under Exchange Act Rule would provide that persons associated acting in its capacity as an SBS Entity 18a–3 were designed to apply to entities with a member whose functions are and the customer’s account solely holds subject to those higher capital related solely and exclusively to SBS SBS and collateral posted as margin in requirements. FINRA notes in this undertaken in such person’s capacity as connection with such SBS. regard that firms engaged in a level of an associated person of an SBS Entity In the Concept Proposal, FINRA SBS dealing below the de minimis are not required to be registered with requested comment on a proposed threshold requiring SBSD registration FINRA. framework for a new SBS-specific may nonetheless elect to register as Finally, SIFMA requested that FINRA margin rule, which would replace the SBSDs, and thereby become subject to provide exceptions for a member dually Interim Pilot Program under existing the SEC’s comprehensive regulatory registered as an SBS Entity from FINRA FINRA Rule 4240 and apply to all SBS framework for such entities, including Rules 2231 (Customer Account in lieu of FINRA’s general margin the margin requirements under Statements) and 4512 (Customer requirements under FINRA Rule Exchange Act Rule 18a–3 tailored to 155 Account Information), in each case, for 4210. SIFMA expressed support for such entities. FINRA does not believe it an account solely holding SBS and the steps noted by FINRA in the would be appropriate to permit related collateral.151 In the Concept Concept Proposal with respect to members to opt-in to only one aspect of harmonizing the new SBS-specific Proposal, FINRA explained its the SEC’s financial responsibility rules margin rule with the SEC’s margin rule preliminary belief that the account for SBSDs instead of complying with for SBSDs, including by including statements required under FINRA Rule proposed FINRA Rule 4240, which, as exceptions from Initial Margin described below, would in some 2231 should reflect a holistic view of a Requirements for Sovereign Entities and respects provide a higher level of member’s relationship with its Financial Market Intermediaries, as well protection for non-SBSD members customer, including SBS transactions as the Variation Margin and Initial engaged in uncleared SBS than SBSDs and positions, if applicable. FINRA Margin Requirements for Multilateral because such members are not further stated that while FINRA Organizations.156 However, SIFMA comprehensively regulated with respect members that are SBS Entities would noted that the proposed margin rule as to their SBS activities. also be subject to the SEC’s portfolio described in the Concept Proposal Alternatively, SIFMA requested that, reconciliation requirements, given the would still diverge from Exchange Act if FINRA does not adopt its suggested importance of customer account Rule 18a–3 in several significant opt-in approach, FINRA harmonize the statements and the different purposes of respects. SIFMA expressed concern that new margin rule with Exchange Act the rules, under the Concept Proposal these differences would impose Rule 18a–3 in certain respects.158 First, FINRA was considering not proposing significant limitations on the ability of SIFMA noted that the proposed new an exception from FINRA Rule 2231 for members that are not SBSDs to transact margin rule as described in the Concept members that are SBS Entities.152 Proposal would not include the same SIFMA acknowledged this rationale 153 See SIFMA Letter at 5. SIFMA also stated that exceptions as Exchange Act Rule 18a–3, generally, but stated its belief that if an although the SEC’s portfolio reconciliation rule including an Initial Margin collection account only holds SBS and related does not expressly cover collateral-related disputes, the NFA has interpreted the parallel CFTC rule to exception for affiliates and an exception collateral, the SEC’s portfolio cover such disputes, and the SEC indicated that an from both Initial Margin and Variation reconciliation requirement should be SBS Entity that is following NFA’s processes in Margin for legacy accounts. As sufficient because it will provide the relation to disputes would also be compliant with described above, FINRA believes an Exchange Act Rule 15Fi–3. See id. at 5 n.4. As counterparty with information on a discussed above, the proposed rule change would exception from including Legacy SBS in periodic basis regarding the parties’ SBS include as a condition to proposed FINRA Rule a Counterparty’s Uncleared SBS portfolio and address the resolution of 0180(f) that portfolio reconciliations and related Account for purposes of the margin disputes, including collateral-related dispute resolution requirements as applied to a customer’s account qualifying for the proposed requirements under proposed FINRA exception must include SBS-related collateral. Rule 4240 is appropriate to the extent 150 See SIFMA Letter at 4. 154 See SIFMA Letter at 5. 151 See SIFMA Letter at 5. 155 See Concept Proposal at 8–9. 157 See SIFMA Letter at 7. 152 See Concept Proposal at 16 n.15. 156 See SIFMA Letter at 6. 158 See SIFMA Letter at 7.

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the member does not have a contractual registered SBSDs, and therefore such disparity highlighted by SIFMA, while right or obligation to collect or deliver members would not be subject to the providing the heightened protection such margin, and is therefore including comprehensive regulatory framework provided by collecting the full Initial such an exception under the proposed applicable to SBSDs, including higher Margin Requirement, or taking the rule change, provided that members capital requirements. Similarly, FINRA associated full capital charge in certain take a corresponding capital charge to does not believe it would be appropriate circumstances, for SBS with other account for the risk of Legacy SBS to permit a non-SBSD member to opt-in Counterparties. (consistent with the SEC’s approach to to using models that the SEC has Fourth, SIFMA requested that FINRA legacy accounts under Exchange Act approved for an affiliate that is itself include an Initial Margin threshold Rule 18a–3). Also as described above, registered as an SBSD. consistent with Exchange Act Rule 18a– while FINRA does not believe a broad Third, SIFMA requested that, when 3’s $50 million threshold.164 SIFMA exception from the Initial Margin ANC Firms transact pursuant to an noted that, because Exchange Act Rule Requirements for SBS with all affiliates exception from the proposed new 18a–3 includes such a threshold while would be consistent with investor margin rule, they should be permitted to FINRA’s proposed new margin rule protection, the proposed rule change use credit risk charges set forth in would not, members subject to the includes more limited exceptions (i) for Exchange Act Rule 15c3–1e in lieu of proposed margin rule would face a all members, from collection of Initial capital charges computed using the significant competitive disadvantage Margin for SBS with Majority Owners, Initial Margin methodology required relative to SBSDs. SIFMA suggested 161 subject to a corresponding capital under the proposed new margin rule. that, if FINRA permitted a member to charge; and (ii) for ANC Firms, from SIFMA stated that this approach should take a capital charge in lieu of collecting collection of Initial Margin for SBS with not pose undue risks to ANC Firms Initial Margin up to the threshold, Majority Owners and Registered or given the significantly higher minimum similar to that permitted by the SEC for Foreign SBS Dealers, subject to taking a net capital and tentative net capital SBSDs, then FINRA could ensure corresponding credit risk charge (as requirements applicable to such firms, protection against credit risks without discussed in further detail below). and cited the SEC’s decision to allow creating an unlevel playing field or FINRA believes these proposed ANC Firms to apply Exchange Act Rule increasing market concentration. Fifth, exceptions, together with the proposed 15c3–1e’s credit risk charges to all SIFMA requested that FINRA adopt a exception for SBS with Financial derivatives transactions not subject to $500,000 minimum transfer amount to Market Intermediaries, should account 162 margin collection requirements. minimize operational burdens and for the vast majority of uncleared SBS FINRA acknowledges that not competitive disadvantages that would entered into by non-SBSDs with permitting all ANC Firms subject to the otherwise be imposed on broker-dealers, affiliates and thus reduce the rule to use credit risk charges in lieu of including when facing SBSDs, in which competitive disparity noted by SIFMA, capital charges could create certain case broker-dealers would be required to while still sufficiently addressing the competitive disparities as between ANC collect or post Variation Margin when potential risks raised by SBS with other Firms that are registered SBSDs (and its SBSD counterparty would not.165 affiliated entities. therefore are subject to Exchange Act FINRA acknowledges that these aspects Second, SIFMA noted that an SBSD Rule 18a–3) and ANC Firms that are not generally may use an approved model to of the proposed rule change differ from registered SBSDs (and therefore would the SEC’s margin rule for SBSDs under calculate initial margin requirements be subject to the Initial Margin and stated that, if standalone broker- Exchange Act Rule 18a–3. However, requirements under proposed FINRA FINRA does not believe the application dealers are not able to use similar Rule 4240). However, FINRA notes that models, the rule may result in of a large threshold or minimum transfer the credit risk charges calculated under amount would be appropriate for competitive disparities between Exchange Act Rule 15c3–1e represent a standalone broker-dealers and broker- uncleared SBS entered into by non- fraction of the Initial Margin SBSD members that would be subject to dealers dually-registered as SBSDs. Requirement that would otherwise be SIFMA therefore requested that FINRA proposed FINRA Rule 4240, as such required to be collected under proposed members will not be subject to the modify the proposed margin rule to FINRA Rule 4240 (or to be taken as a provide that, if the SEC has approved an comprehensive regulatory framework capital deduction in certain applicable to SBSDs, including higher affiliate of a standalone broker-dealer to 163 circumstances as described above). minimum capital requirements. FINRA use an initial margin model, such as the Therefore, as described above, FINRA ISDA ‘‘Standard Initial Margin Model,’’ also notes that, from an operational believes it is appropriate to provide a perspective, member broker-dealers then such broker-dealer should be able limited exception permitting ANC Firms to use the same model to the same should already have operational to use credit risk charges when they processes in place for the collection of extent as a broker-dealer dually- transact with registered SBSD affiliates registered as an SBSD would be able to margin without any threshold or or affiliates that are subject to under the SEC’s margin rules.159 SIFMA minimum transfer amount. Further, comparable capital requirements in a further requested that the use of such a FINRA believes that adopting a foreign jurisdiction. FINRA believes this model should not be limited to products threshold or minimum transfer amount proposed exception should substantially that are Basic CDS or Basic SBS.160 under proposed FINRA Rule 4240 address the potential competitive FINRA believes similar considerations would incentivize restructuring of margin accounts as Basic SBS given that apply with respect to the use of SEC- 161 See SIFMA Letter at 8. FINRA Rule 4210 does not provide for approved Initial Margin models as for 162 See SIFMA Letter at 8–9. permitting a non-SBSD member to opt- 163 Specifically, these charges are the are the any threshold or minimum transfer in to Exchange Act Rule 18a–3. product of (x) 8%, (y) the counterparty risk amount. To prevent regulatory arbitrage, Proposed FINRA Rule 4240 would weighting (20% for internal AAA/AA rating, 50% FINRA is therefore not proposing to apply only to members that are not for internal investment grade rating or 150% for include any threshold or minimum internal non-investment grade rating), and (z) a potential exposure computed using a VaR model (or 159 See SIFMA Letter at 8. if not modeled, by applying the capital rule haircut 164 See SIFMA Letter at 9. 160 See SIFMA Letter at 8 n.6. to the underlying). See 17 CFR 15c3–1e. 165 See SIFMA Letter at 9.

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transfer amount under proposed FINRA permit house margin and stress test Comments may be submitted by any of Rule 4240. requirements for portfolio margin the following methods: Fifth, SIFMA noted that the definition accounts to recognize risk offsets across of Basic CDS as described in the all types of swaps, SBS and other Electronic Comments Concept Proposal would not seem to positions permitted in the account. • Use the Commission’s internet cover an option on a CDS, i.e., CDS FINRA notes that this request relates to comment form (http://www.sec.gov/ swaptions. SIFMA requested that ‘‘house margin,’’ which generally refers rules/sro.shtml); or FINRA change the definition of Basic to margin requirements that a member’s • CDS to include swaptions, so that portfolio margin risk management Send an email to rule-comments@ swaptions are treated the same as the procedures may impose in addition to, sec.gov. Please include File Number SR– underlying CDS, to avoid a situation or parallel to, the requirements under FINRA–2021–008 on the subject line. that would make it difficult for FINRA the applicable portfolio margin model. Paper Comments members to employ CDS swaption FINRA believes that the practice of hedging techniques.166 SIFMA noted recognizing risk offsets across all types • Send paper comments in triplicate that such a change would also eliminate of swaps, SBS and other positions to Secretary, Securities and Exchange the added costs market participants permitted in the account for purposes of Commission, 100 F Street NE, would otherwise incur in requesting calculating house margin and related Washington, DC 20549–1090. approval from FINRA of the appropriate stress test requirements is permissible Initial Margin Requirement for under current FINRA Rule 4210, and All submissions should refer to File swaptions. FINRA notes that there is FINRA does not intend to alter such Number SR–FINRA–2021–008. This file some uncertainty regarding the permissibility under the proposed rule number should be included on the appropriateness of applying the change. subject line if email is used. To help the generally applicable haircut grid for • SIFMA also requested that FINRA Commission process and review your CDS under Exchange Act Rule 15c3– clarify that SBS may be held in a comments more efficiently, please use 1(c)(2)(vi)(P)(1) to CDS swaptions. As portfolio margin account even if the only one method. The Commission will such, FINRA believes it would be underlier for the SBS would not be post all comments on the Commission’s beneficial for SIFMA or other market eligible for portfolio margining, given internet website (http://www.sec.gov/ participants to submit an application for that Exchange Act Rule 18a–3 imposes rules/sro.shtml). Copies of the approval of an Initial Margin no limitation on the types of SBS that submission, all subsequent Requirement for CDS swaptions under can be margined using the methodology amendments, all written statements proposed FINRA Rule 4240(2)(C), as set forth in Appendix A to Exchange Act with respect to the proposed rule described above. FINRA notes that it Rule 15c3–1. FINRA notes that, under change that are filed with the would consider such a request the proposed rule change, the eligibility Commission, and all written expeditiously provided that such an of specific SBS for portfolio margining communications relating to the application included all relevant would depend on whether such SBS can proposed rule change between the supporting information. SIFMA also be valued by a theoretical pricing model Commission and any person, other than expressed concern that the Basic CDS approved by the SEC for valuing that those that may be withheld from the definition could be read to require type of SBS. As such, an SBS would be public in accordance with the physical settlement of CDS. Given the permitted to be held in a portfolio provisions of 5 U.S.C. 552, will be prevalence of auction settlement in the margin account if it satisfies this available for website viewing and CDS market, SIFMA requested that the condition, regardless of whether the printing in the Commission’s Public definition of Basic Single-Name Credit underlier for the SBS would itself be Reference Room, 100 F Street NE, Default Swap (a component of Basic eligible for portfolio margining. Washington, DC 20549, on official CDS) specifically contemplate auction III. Date of Effectiveness of the business days between the hours of 10 settlement as well.167 FINRA notes that Proposed Rule Change and Timing for a.m. and 3 p.m. Copies of such filing it intends for the definition of Basic Commission Action also will be available for inspection and CDS, as described in greater detail copying at the principal office of above, to cover both physical and Within 45 days of the date of FINRA. All comments received will be publication of this notice in the Federal auction settlement. posted without change. Persons Register or within such longer period (i) Finally, SIFMA made several submitting comments are cautioned that as the Commission may designate up to comments regarding paragraph (g) (the we do not redact or edit personal 90 days of such date if it finds such portfolio margin section) of FINRA Rule identifying information from comment 168 longer period to be appropriate and 4210: submissions. You should submit only • SIFMA requested that FINRA publishes its reasons for so finding or information that you wish to make conform FINRA Rule 4210’s definitions (ii) as to which the self-regulatory available publicly. All submissions of ‘‘related instrument’’ and ‘‘underlying organization consents, the Commission should refer to File Number SR–FINRA– instrument’’ to the definitions in will: Appendix A to Exchange Act Rule (A) By order approve or disapprove 2021–008 and should be submitted on 15c3–1, which now include swaps and such proposed rule change, or or before June 2, 2021. SBS. FINRA will consider these (B) institute proceedings to determine For the Commission, by the Division of suggestions, but does not believe these whether the proposed rule change Trading and Markets, pursuant to delegated changes are necessary as a part of this should be disapproved. authority.169 rulemaking. Jill M. Peterson, • IV. Solicitation of Comments SIFMA further requested that Assistant Secretary. FINRA clarify FINRA Rule 4210 to Interested persons are invited to submit written data, views and [FR Doc. 2021–10055 Filed 5–11–21; 8:45 am] 166 See SIFMA Letter at 9–10. arguments concerning the foregoing, BILLING CODE 8011–01–P 167 See SIFMA Letter at 10. including whether the proposed rule 168 See SIFMA Letter at 6. change is consistent with the Act. 169 17 CFR 200.30–3(a)(12).

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SECURITIES AND EXCHANGE SECURITIES AND EXCHANGE Amendment No. 1 for inclusion in the COMMISSION COMMISSION public comment file.8 The Commission has received no other comment letter on [Release No. 34–91786; File No. SR– [Release No. 34–91791; File No. SR–NYSE– the proposed rule change, as modified NYSEArca–2020–105] 2020–93] by Partial Amendment No. 1. Self-Regulatory Organizations; NYSE Self-Regulatory Organizations; New Section 19(b)(2) of the Act 9 provides Arca, Inc.; Notice of Withdrawal of a York Stock Exchange LLC; Notice of that, after initiating proceedings, the Proposed Rule Change To List and Designation of a Longer Period for Commission shall issue an order Trade the Shares of the Teucrium Commission Action on Proceedings To approving or disapproving the proposed Water Fund Under NYSE Arca Rule Determine Whether To Approve or rule change not later than 180 days after 8.200–E, Commentary .02 Disapprove a Proposed Rule Change, the date of publication of notice of filing as Modified by Partial Amendment No. of the proposed rule change. The May 6, 2021. 1, To Amend Rules 7.35 and 7.35A On November 25, 2020, NYSE Arca, Commission may extend the period for Inc. (‘‘Exchange’’ or ‘‘NYSE Arca’’) filed May 7, 2021. issuing an order approving or with the Securities and Exchange On November 3, 2020, New York disapproving the proposed rule change, Commission (‘‘Commission’’), pursuant Stock Exchange LLC (‘‘NYSE’’ or however, by not more than 60 days if to Section 19(b)(1) of the Securities ‘‘Exchange’’) filed with the Securities the Commission determines that a Exchange Act of 1934 (‘‘Act’’) 1 and Rule and Exchange Commission longer period is appropriate and 19b–4 thereunder,2 a proposed rule (‘‘Commission’’), pursuant to Section publishes the reasons for such change to list and trade the shares of the 19(b)(1) of the Securities Exchange Act determination. The proposed rule Teucrium Water Fund under NYSE Arca of 1934 (‘‘Act’’) 1 and Rule 19b–4 change was published for notice and Rule 8.200–E, Commentary .02. thereunder,2 a proposed rule change to comment in the Federal Register on The proposed rule change was amend Rule 7.35 regarding November 17, 2020.10 May 16, 2021, is published for comment in the Federal dissemination of Auction Imbalance 180 days from that date, and July 15, Register on December 14, 2020.3 On Information if a security is an IPO or 2021, is 240 days from that date. January 14, 2021, pursuant to Section Direct Listing and has not had its IPO 19(b)(2) of the Act,4 the Commission Auction or Direct Listing Auction, and The Commission finds it appropriate designated a longer period within which Rule 7.35A regarding DMM to designate a longer period within to approve the proposed rule change, consultations in connection with an IPO which to issue an order approving or disapprove the proposed rule change, or or Direct Listing. The proposed rule disapproving the proposed rule change, institute proceedings to determine change was published for comment in as modified by Partial Amendment No. whether to disapprove the proposed the Federal Register on November 17, 1, so that it has sufficient time to 5 rule change. On March 9, 2021, the 2020.3 On December 18, 2020, pursuant consider the proposed rule change. Commission instituted proceedings to Section 19(b)(2) of the Act,4 the Accordingly, the Commission, pursuant 6 under Section 19(b)(2)(B) of the Act to Commission designated a longer period to Section 19(b)(2) of the Act,11 determine whether to approve or within which to either approve the designates July 15, 2021, as the date by 7 disapprove the proposed rule change. proposed rule change, disapprove the which the Commission shall either The Commission has received proposed rule change, or institute approve or disapprove the proposed comments on the proposed rule proceedings to determine whether to rule change (File No. SR–NYSE–2020– change.8 On May 6, 2021, the Exchange approve or disapprove the proposed 93) as modified by Partial Amendment withdrew the proposed rule change rule change.5 On February 12, 2021, the No. 1. (SR–NYSEArca–2020–105). Commission instituted proceedings For the Commission, by the Division of under Section 19(b)(2)(B) of the Act 6 to For the Commission, by the Division of Trading and Markets, pursuant to delegated Trading and Markets, pursuant to delegated determine whether to approve or 12 authority.9 disapprove the proposed rule change.7 authority. J. Matthew DeLesDernier, On April 12, 2021, the Exchange filed Jill M. Peterson, Assistant Secretary. Partial Amendment No. 1 to the Assistant Secretary. [FR Doc. 2021–09974 Filed 5–11–21; 8:45 am] proposed rule change with the [FR Doc. 2021–10057 Filed 5–11–21; 8:45 am] BILLING CODE 8011–01–P Commission and submitted Partial BILLING CODE 8011–01–P

12 17 CFR 200.30–3(a)(57). 1 15 U.S.C. 78s(b)(1). 1 15 U.S.C. 78s(b)(1). 2 17 CFR 240.19b–4. 8 In Partial Amendment No. 1, the Exchange 2 17 CFR 240.19b–4. 3 See Securities Exchange Act Release No. 90387 provides additional background in support of, but 3 See Securities Exchange Act Release No. 91356 (Nov. 10, 2020), 85 FR 73322 (Nov. 17, 2020) does not propose any further modification to the (March 18, 2021), 86 FR 15759 (March 24, 2021) (‘‘Notice’’). Comments received on the proposed Exchange rules in the initial proposal. See Letter (‘‘Notice’’). rule change are available on the Commission’s from Martha Redding, Associate General Counsel, 4 See proposed Rule 531(a); see also Notice at website at https://www.sec.gov/comments/sr-nyse- NYSE LLC, to Secretary, Commission (April 12, 15760. 2020-93/srnyse202093. 2021). Partial Amendment No. 1 is available at 5 See proposed Rule 531(a); see also Notice at 4 15 U.S.C. 78s(b)(2). https://www.sec.gov/comments/sr-nyse-2020-93/ 15759. The proposed Report would not include 5 See Securities Exchange Act Release No. 90723 srnyse202093-8662680-235308.pdf. real-time market data. See Notice at 15759. (Dec. 18, 2020), 85 FR 84446 (Dec. 28, 2020). 9 15 U.S.C. 78s(b)(2). 6 See proposed Rule 531(a)(1)–(2); see also Notice 6 15 U.S.C. 78s(b)(2)(B). 10 See supra note 3. at 15759–60. The Exchange states that only 7 See Securities Exchange Act Release No. 91121, 11 15 U.S.C. 78s(b)(2). displayed resting orders would be included in the (Feb. 12, 2021), 86 FR 10386 (Feb. 19, 2021). 12 17 CFR 200.30–3(a)(57). Report, as the Exchange does not currently offer any non-displayed orders types on its options trading

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SECURITIES AND EXCHANGE order, the first response to the resting and type of the response; 12 (D) the time COMMISSION order that successfully executed against difference between when the resting the resting order, and the Recipient order was received by the Exchange and [Release No. 34–91787; File No. SR– when the first response that executed EMERALD–2021–09] Member’s responses that missed executing against the resting order.6 against the resting order was received by 13 Self-Regulatory Organizations; MIAX Proposed Rule 531(a)(1) describes this the Exchange; and (E) whether the Emerald, LLC; Order Approving time-related information and additional response was entered by the Recipient 14 Proposed Rule Change To Adopt detail. With regard to each resting order Member. Exchange Rule 531(a), Reports, To covered by the proposed Report, the With regard to response(s) sent by the Recipient Member, the proposed Report Provide for a New ‘‘Liquidity Taker proposed Report would provide: (A) would provide: (A) A Recipient Member Event Report’’ The time the resting order was received identifier; (B) the time difference by the Exchange; 7 (B) symbol; (C) order between when the first response that May 6, 2021. reference number, which is a unique executes against the resting order was reference number assigned to a new I. Introduction received by the Exchange and when order at the time of receipt; (D) whether On March 5, 2021, MIAX EMERALD, each response sent by the Recipient the Recipient Member is an affiliate of LLC (‘‘MIAX Emerald’’ or ‘‘Exchange’’) Member was received by the Exchange, the member that entered the resting filed with the Securities and Exchange regardless of whether the Recipient order; 8 (E) origin type (e.g., priority Commission (‘‘Commission’’), pursuant Member’s responses executed or not; 15 customer, market maker); (F) side (buy to Section 19(b)(1) of the Securities (C) size and type of each response or sell); and (G) displayed price and size Exchange Act of 1934 (‘‘Act’’) 1 and Rule submitted by the Recipient Member; of the resting order.9 19b–4 thereunder,2 a proposed rule and (D) response reference number, change to adopt Exchange Rule (‘‘Rule’’) With regard to the execution of the which is a unique reference number 531(a) to provide for a new ‘‘Liquidity resting order, the proposed Report attached to the response by the Taker Event Report’’ (‘‘Report’’). The would provide: (A) The EBBO at the Recipient Member.16 proposed rule change was published for time of execution; 10 (B) the ABBO at the In addition, proposed Rule 531(a)(3) comment in the Federal Register on time of execution; 11 (C) the time the would state that the Report would only March 24, 2021.3 The Commission has first response that executed against the include trading data related to the received no comments on the proposed resting order was received by the Recipient Member, and would not rule change. This order approves the Exchange and the size of the execution include any other member’s trading data proposed rule change. other than that listed in paragraphs (1)(i) 6 See proposed Rule 531(a)(1)–(2); see also Notice and (ii) of the proposed rule.17 Further, II. Description of the Proposed Rule at 15759–60. The Exchange states that only the Exchange states that the content of Change displayed resting orders would be included in the the Report would be specific and Report, as the Exchange does not currently offer any The Report that the Exchange non-displayed orders types on its options trading tailored to the Recipient Member, and proposes to offer pursuant to new Rule platform. See Notice at 15760 n.7. any data included in the Report that 531(a) would be an historical options 7 This would reflect, in nanoseconds, the time at relates to a member other than the data product, generally available on a which the resting order was received by the Recipient Member would be T+1 basis, that would provide certain Exchange’s system. Id. at 15760 n.8. anonymized.18 8 The Exchange states that the Report would only According to the Exchange, the information from the prior trading day indicate whether the Recipient Member is an to any member that wishes to subscribe affiliate of the member that entered the resting order proposed Report is designed for to the Report.4 The information set forth and would not include any other information that members that are interested in gaining in the proposed Report would be may indicate the identity of the member that insight into latency in connection with entered the resting order. Id. at 15760 n.12. designed to identify for any subscribing orders that failed to execute against an According to the Exchange, including this 19 member (‘‘Recipient Member’’) the information would allow the Recipient Member to order resting on the Exchange’s book. amount of time by which certain orders better understand the scenarios in which it may Exchange members have periodically from the Recipient Member that may execute against the orders of its affiliates. Id. at requested from the Exchange’s trading 15761. have been marketable missed an 9 See proposed Rule 531(a)(1)(i); see also Notice execution due to other liquidity- 12 This time value would reflect, in nanoseconds, at 15760. The Exchange states that the displayed the time at which the response was received by the accessing orders responding faster to price of the resting order may be different from the Exchange’s network, which is before the response resting interest on the Exchange’s book.5 ultimate execution price when a resting order is would be received by the Exchange’s system. See displayed and ranked at different prices upon entry Notice at 15760 n.21. Specifically, for instances during the to avoid a locked or crossed market. See Notice at 13 This time difference would be provided in prior trading day where a Recipient 15760 n.16. nanoseconds. Id. at 15760 n.22. Member attempted to execute against a 10 The Exchange uses the term ‘‘EBBO’’ to mean 14 See proposed Rule 531(a)(1)(ii); see also Notice the best bid or offer on the Exchange. See Rule 100; resting order within 200 microseconds at 15760. If not entered by the Recipient Member, see also Notice at 15760 n.17. If the resting order of the Exchange’s receipt of the resting this data point would be left blank so as not to executes against multiple contra-side responses, include any identifying information about other order, the proposed Report would only the EBBO at the time of the execution against member activity. See Notice at 15761. provide time-related information and the first response would be included. See proposed 15 Rule 531(a)(1)(ii)(A). This time difference would be provided in additional detail regarding the resting nanoseconds. For purposes of calculating this 11 The Exchange uses the term ‘‘ABBO’’ or ‘‘Away duration of time, the Exchange would use the times Best Bid or Offer’’ to mean the best bid(s) or offer(s) 1 15 U.S.C. 78s(b)(1). that the resting order and the Recipient Member’s disseminated by other Eligible Exchanges (defined 2 response(s) are received by the Exchange’s network, 17 CFR 240.19b–4. in Rule 1400(g)) and calculated by the Exchange 3 both of which would be before the order and See Securities Exchange Act Release No. 91356 based on market information received by the response(s) would be received by the Exchange’s (March 18, 2021), 86 FR 15759 (March 24, 2021) Exchange from the Options Price Reporting system. Id. at 15760 n.23. (‘‘Notice’’). Authority (‘‘OPRA’’). See Rule 100; see also Notice 16 4 See proposed Rule 531(a); see also Notice at at 15760 n.19. If the resting order executes against See proposed Rule 531(a)(1)(iii); see also Notice 15760. multiple contra-side responses, only the ABBO at at 15760. 5 See proposed Rule 531(a); see also Notice at the time of the execution against the first response 17 See proposed Rule 531(a)(3). 15759. The proposed Report would not include would be included. See proposed Rule 18 See Notice at 15759. real-time market data. See Notice at 15759. 531(a)(1)(ii)(B). 19 Id. at 15761.

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operations personnel information equitable principles of trade, to remove IV. Conclusion concerning the timeliness of their impediments to and perfect the It is therefore ordered, pursuant to incoming orders and efficacy of their mechanism of a free and open market Section 19(b)(2) of the Act,32 that the attempts to execute against resting and a national market system, and, in proposed rule change (SR–EMERALD– 20 liquidity. The Exchange states that the general, to protect investors and the 2021–09), be, and hereby is, approved. purpose of the proposed Report is to public interest, and that those rules not provide Recipient Members with this For the Commission, by the Division of be designed to permit unfair Trading and Markets, pursuant to delegated type of data in a standardized format discrimination between customers, authority.33 and on an equal basis.21 The Exchange issuers, brokers, or dealers. J. Matthew DeLesDernier, believes that Recipient Members may use the data to optimize their models As discussed above, the Exchange Assistant Secretary. and trading patterns in an effort to yield currently fields ad hoc requests from [FR Doc. 2021–09975 Filed 5–11–21; 8:45 am] better execution results.22 In addition, members for information regarding the BILLING CODE 8011–01–P the Exchange states that the proposed timeliness of their attempts to execute Report is based on a similar data against resting options liquidity on the product that another exchange offers for Exchange’s book.28 The proposal is SECURITIES AND EXCHANGE equity securities,23 and that certain designed to offer this type of latency COMMISSION information that would be provided in information in a systematized way and [Release No. 34–91788; File No. SR–NSCC– the proposed Report, including in standardized format to any member that 2021–002] particular the time duration by which a chooses to subscribe to the Report. As Recipient Member’s orders missed an a result, the Commission believes that Self-Regulatory Organizations; execution, is similar to information that the proposal will make latency National Securities Clearing is provided in the other exchange’s data information for liquidity-seeking orders Corporation; Notice of Designation of product.24 Moreover, according to the available to Exchanges members in a Longer Period for Commission Action Exchange, other information that would more equalized manner and will and Longer Period for Comment on be contained in the proposed Report increase transparency, particularly for Proposed Rule Change To Amend the already is available from existing data Recipient Members that may not have Supplemental Liquidity Deposit Requirements sources, such as OPRA and the the expertise to generate the same Exchange’s proprietary data feeds, or is information on their own. The May 7, 2021. information that the Exchange would Commission also believes that the provide as a convenience to the proposed Report may better enable I. Introduction Recipient Member and that would be Recipient Members to increase the fill On March 5, 2021, National Securities known to the Recipient Member even if rates for their liquidity-seeking orders. Clearing Corporation (‘‘NSCC’’) filed not included in the Report.25 At the same time, as is also discussed with the Securities and Exchange III. Discussion and Commission above, the Report is designed to prevent Commission (‘‘Commission’’) proposed Findings a Recipient Member from learning other rule change SR–NSCC–2021–002 (the members’ sensitive trading information. ‘‘Proposed Rule Change’’) pursuant to After careful review, the Commission The Report would not be a real-time Section 19(b)(1) of the Securities finds that the proposed rule change is 1 market data product, as it would Exchange Act of 1934 (‘‘Act’’) and Rule consistent with the requirements of the 19b–4 thereunder 2 to amend its Act and the rules and regulations provide only historical trading data for the previous trading day, generally on a supplemental liquidity deposit thereunder applicable to a national 3 29 requirements. The Proposed Rule securities exchange.26 In particular, the T+1 basis. In addition, the data in the Report regarding incoming orders that Change was published for comment in Commission finds that the proposal is the Federal Register on March 24, failed to execute would be specific to consistent with Section 6(b)(5) of the 2021,4 and the Commission has received 27 the Recipient Member’s orders,30 and Act, which requires, among other comments in support of the changes other information in the proposed things, that the rules of a national proposed therein.5 securities exchange be designed to Report regarding resting orders and prevent fraudulent and manipulative executions would be anonymized if it 32 15 U.S.C. 78s(b)(2). acts and practices, to promote just and relates to a member other than the 33 17 CFR 200.30–3(a)(12). Recipient Member.31 Accordingly, 1 15 U.S.C. 78s(b)(1). 20 Id. at 15759. consistent with Section 6(b)(5) of the 2 17 CFR 240.19b–4. 21 Id. The Exchange states that it intends to Act, the Commission believes that the 3 See Notice of Filing, infra note 4, at 86 FR submit a separate rule filing with the Commission 15738. On March 5, 2021, NSCC also filed the proposal is designed to prevent proposals contained in the Proposed Rule Change to propose fees for the Report. Id. at 15759 n.3. fraudulent and manipulative acts and 22 Id. at 15761. as advance notice SR–NSCC–2021–801 (the ‘‘Advance Notice’’) with the Commission pursuant 23 Id. at 15759 n.6 (referencing the Missed practices, promote just and equitable principles of trade, remove to Section 806(e)(1) of the Dodd-Frank Wall Street Opportunity—Latency report that is part of the Reform and Consumer Protection Act entitled the Trading Insights offering of the NASDAQ Stock impediments to and perfect the Payment, Clearing, and Settlement Supervision Act Market LLC (‘‘Nasdaq’’)); see also Nasdaq Rules, mechanism of a free and open market of 2010 (‘‘Clearing Supervision Act’’), 12 U.S.C. Equity Section 7, Rule 146(a)(2); Securities and a national market system, and 5465(e)(1), and Rule 19b–4(n)(1)(i) of the Act, 17 Exchange Act Release No. 78886 (September 20, CFR 240.19b–4(n)(1)(i). Notice of filing of the 2016), 81 FR 66113 (September 26, 2016) (SR– protect investors and the public interest, Advance Notice was published in the Federal NASDAQ–2016–101) (order approving Nasdaq and is not designed to permit unfair Register on March 24, 2021. Securities Exchange Trading Insights data product). discrimination. Act Release No. 91347 (March 18, 2021), 86 FR 24 See Notice at 15760–62. 15750 (March 24, 2021) (File No. SR–NSCC–2021– 25 Id. 801). 28 26 In approving this proposed rule change, the See Notice at 15759. 4 Securities Exchange Act Release No. 91350 Commission has considered the proposed rule’s 29 See proposed Rule 531(a)(4); see also Notice at (March 18, 2021), 86 FR 15738 (March 24, 2021) impact on efficiency, competition, and capital 15760. (File No. SR–NSCC–2021–002) (‘‘Notice of Filing’’). formation. See 15 U.S.C. 78c(f). 30 See proposed Rule 531(a)(1)(iii) and (a)(3). 5 Comments are available at https://www.sec.gov/ 27 15 U.S.C. 78f(b)(5). 31 See Notice at 15759. comments/sr-nscc-2021-002/srnscc2021002.htm. To

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Section 19(b)(2) of the Act 6 provides thereunder. Please note that comments For the Commission, by the Division of that within 45 days of the publication of previously received on the substance of Trading and Markets, pursuant to delegated notice of the filing of a proposed rule the proposed rule change will be authority.10 change, or within such longer period up considered together with comments Jill M. Peterson, to 90 days as the Commission may submitted in response to this notice. Assistant Secretary. designate if it finds such longer period Therefore, while commenters are free to [FR Doc. 2021–10054 Filed 5–11–21; 8:45 am] to be appropriate and publishes its submit additional comments at this BILLING CODE 8011–01–P reasons for so finding or as to which the time, they need not re-submit earlier self-regulatory organization consents, comments. the Commission shall either approve the Comments may be submitted by any SECURITIES AND EXCHANGE proposed rule change, disapprove the of the following methods: COMMISSION proposed rule change, or institute Electronic Comments [Release No. 34–91784; File No. SR– proceedings to determine whether the CboeEDGA–2021–012] proposed rule change should be • Use the Commission’s internet disapproved. The 45th day after comment form (http://www.sec.gov/ Self-Regulatory Organizations; Cboe publication of the notice for the rules/sro.shtml); or EDGA Exchange, Inc.; Notice of Filing proposed rule change is effectively May and Immediate Effectiveness of a • Send an email to rule-comments@ 7, 2021. Proposed Rule Change To Amend the sec.gov. Please include File Number SR– The Commission is extending the 45- Fee Schedule day time period for Commission action NSCC–2021–002 on the subject line. on the proposed rule change. The Paper Comments May 6, 2021. Commission finds that it is appropriate Pursuant to Section 19(b)(1) of the to designate a longer period within • Send paper comments in triplicate Securities Exchange Act of 1934 (the which to take action on the proposed to Secretary, Securities and Exchange ‘‘Act’’),1 and Rule 19b–4 thereunder,2 rule change so that it has sufficient time Commission, 100 F Street NE, notice is hereby given that on May 3, to consider and take action on the Washington, DC 20549. 2021, Cboe EDGA Exchange, Inc. (the proposed rule change. All submissions should refer to File ‘‘Exchange’’ or ‘‘EDGA’’) filed with the Accordingly, pursuant to Section Number SR–NSCC–2021–002. This file Securities and Exchange Commission 7 19(b)(2) of the Act and for the reasons number should be included on the (the ‘‘Commission’’) the proposed rule stated above, the Commission subject line if email is used. To help the change as described in Items I, II, and designates June 21, 2021 as the date by Commission process and review your III below, which Items have been which the Commission shall either comments more efficiently, please use prepared by the Exchange. The approve, disapprove, or institute only one method. The Commission will Commission is publishing this notice to proceedings to determine whether to post all comments on the Commission’s solicit comments on the proposed rule disapprove the proposed rule change internet website (http://www.sec.gov/ change from interested persons. (File No. SR–NSCC–2021–002). rules/sro.shtml). Copies of the The Commission also seeks to extend I. Self-Regulatory Organization’s submission, all subsequent the comment period to help further Statement of the Terms of Substance of amendments, all written statements inform its analysis of the proposed rule the Proposed Rule Change with respect to the proposed rule change. The comment period for the change that are filed with the Cboe EDGA Exchange, Inc. (the proposed rule change ended on April Commission, and all written ‘‘Exchange’’ or ‘‘EDGA’’) is filing with 14, 2021.8 As of May 5, 2021, the communications relating to the the Securities and Exchange Commission has received numerous proposed rule change between the Commission (‘‘Commission’’) a comment letters to the proposed rule Commission and any person, other than proposed rule change to amend the fee change.9 The Commission is extending those that may be withheld from the schedule. The text of the proposed rule the comment period for the proposed public in accordance with the change is provided in Exhibit 5. rule change to allow interested persons provisions of 5 U.S.C. 552, will be The text of the proposed rule change additional time to analyze the issues available for website viewing and is also available on the Exchange’s and prepare their comments. printing in the Commission’s Public website (http://markets.cboe.com/us/ Accordingly, the Commission _ Reference Room, 100 F Street NE, equities/regulation/rule filings/edga/), designates May 31, 2021 as the date Washington, DC 20549 on official at the Exchange’s Office of the comments should be submitted on or business days between the hours of Secretary, and at the Commission’s before. 10:00 a.m. and 3:00 p.m. Copies of the Public Reference Room. Specifically, the Commission invites filing also will be available for interested persons to provide views, II. Self-Regulatory Organization’s inspection and copying at the principal data, and arguments concerning the Statement of the Purpose of, and office of NSCC and on DTCC’s website proposed rule change, including Statutory Basis for, the Proposed Rule (http://dtcc.com/legal/sec-rule- whether the proposed rule change is Change filings.aspx). All comments received consistent with the Act and the In its filing with the Commission, the will be posted without change. Persons applicable rules or regulations Exchange included statements submitting comments are cautioned that concerning the purpose of and basis for we do not redact or edit personal date, the comments received generally support the the proposed rule change and discussed identifying information from comment proposal. any comments it received on the 6 submissions. You should submit only 15 U.S.C. 78s(b)(2). proposed rule change. The text of these 7 Id. information that you wish to make statements may be examined at the 8 Notice of Filing, supra note 4, 86 FR at 15738. available publicly. All submissions 9 See supra note 5. The comments received should refer to File Number SR–NSCC– generally support the proposal, although they do 10 17 CFR 200.30–3(a)(31). not generally provide substantive analysis of the 2021–002 and should be submitted on 1 15 U.S.C. 78s(b)(1). proposal. or before June 2, 2021. 2 17 CFR 240.19b–4.

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places specified in Item IV below. The Members meeting certain volume The Exchange operates in a highly Exchange has prepared summaries, set thresholds. Specifically, Tier 2 currently competitive market in which market forth in sections A, B, and C below, of provides an opportunity for Members to participants can readily direct order the most significant aspects of such receive an enhanced rebate of $0.0028 flow to competing venues if they deem statements. per share for qualifying liquidity fee levels at a particular venue to be removing orders (i.e., yielding fee codes excessive or incentives to be A. Self-Regulatory Organization’s N,4 W,5 6,6 and BB 7), where a Member insufficient. The proposed rule change Statement of the Purpose of, and adds or removes an ADV 8 greater than reflects a competitive pricing structure Statutory Basis for, the Proposed Rule or equal to 0.65% of the TCV.9 Now, the designed to incentivize market Change Exchange proposes to eliminate Tier 2 participants to direct their order flow to 1. Purpose of the Remove Volume Tiers. The the Exchange, which the Exchange The Exchange proposes to amend its Exchange no longer believes Tier 2 is believes would enhance market quality fee schedule by eliminating Tier 2 of the necessary and notes the Exchange is not to the benefit of all Members. Remove Volume Tiers. required to maintain such an incentive. In particular, the Exchange believes The Exchange first notes that it Further, the Exchange would rather eliminating Tier 2 of the Remove operates in a highly competitive market redirect future resources and funding Volume Tiers is reasonable because the in which market participants can into other programs and tiers intended Exchange is not required to maintain readily direct order flow to competing to incentivize increased order flow. such a tier, and Members still have a number of other opportunities and a venues if they deem fee levels at a 2. Statutory Basis particular venue to be excessive or variety of ways to receive enhanced incentives to be insufficient. More The Exchange believes that the rebates. Moreover, as noted above, the specifically, the Exchange is only one of proposed rule change is consistent with Exchange would rather redirect future 10 16 registered equities exchanges, as well the objectives of Section 6 of the Act, resources and funding into other as a number of alternative trading in general, and furthers the objectives of programs and tiers intended to 11 systems and other off-exchange venues Section 6(b)(4), in particular, as it is incentivize increased order flow. The that do not have similar self-regulatory designed to provide for the equitable Exchange believes the proposal to responsibilities under the Exchange Act, allocation of reasonable dues, fees and eliminate Tier 2 of the Remove Volume to which market participants may direct other charges among its Members and Tiers is also equitable and not unfairly their order flow. Based on publicly issuers and other persons using its discriminatory because it applies to all available information,3 no single facilities. The Exchange also believes Members. that the proposed rule change is registered equities exchange has more B. Self-Regulatory Organization’s consistent with the objectives of Section than 15% of the market share. Thus, in Statement on Burden on Competition such a low-concentrated and highly 6(b)(5) 12 requirements that the rules of The Exchange does not believe that competitive market, no single equities an exchange be designed to prevent the proposed rule change will impose exchange possesses significant pricing fraudulent and manipulative acts and any burden on competition that is not power in the execution of order flow. practices, to promote just and equitable necessary or appropriate in furtherance The Exchange believes that the ever- principles of trade, to foster cooperation of the purposes of the Act. Particularly, shifting market share among the and coordination with persons engaged in regulating, clearing, settling, the Exchange does not believe the exchanges from month to month proposal to eliminate Tier 2 of the demonstrates that market participants processing information with respect to, and facilitating transactions in Remove Volume Tiers will impose any can shift order flow or discontinue to burden on intramarket competition that reduce use of certain categories of securities, to remove impediments to and perfect the mechanism of a free and is not necessary or appropriate in products, in response to fee changes. furtherance of the purposes of the Act Accordingly, competitive forces open market and a national market system, and, in general, to protect because the proposed change applies to constrain the Exchange’s transaction all Members equally, in that no Member fees, and market participants can readily investors and the public interest, and, particularly, is not designed to permit will continue to be eligible for the tier. trade on competing venues if they deem As discussed above, the Exchange is not pricing levels at those other venues to unfair discrimination between customers, issuers, brokers, or dealers. required to maintain such an incentive. be more favorable. Additionally, in Also, as previously discussed, the response to the competitive Exchange operates in a highly environment, the Exchange offers tiered 4 Fee code N is appended to orders removing liquidity from EDGA (Tape C). competitive market. Members have pricing which provides Members 5 Fee code W is appended to orders removing numerous alternative venues that they opportunities to qualify for higher liquidity from EDGA (Tape A). may participate on and director their rebates or reduced fees where certain 6 Fee code 6 is appended to orders removing order flow, including 15 other options volume criteria and thresholds are met. liquidity from EDGA, pre and post market (All exchanges and off-exchange venues. Tiered pricing provides an incremental Tapes). 7 Fee code BB is appended to orders removing Additionally, the Exchange represents a incentive for Members to strive for liquidity from EDGA (Tape B). small percentage of the overall market. higher tier levels, which provides 8 ADV means daily volume calculated as the Based on publicly available information, increasingly higher benefits or discounts number of shares added to, removed from, or routed no single options exchange has more for satisfying increasingly more by, the Exchange, or any combination or subset 13 thereof, per day. ADV is calculated on a monthly than 15% of the market share. stringent criteria. Therefore, no exchange possesses Pursuant to footnote 7 of the Fee basis. 9 TCV means total consolidated volume significant pricing power in the Schedule, the Exchange offers Remove calculated as the volume reported by all exchanges execution of option order flow. Indeed, Volume Tiers that provide a rebate to and trade reporting facilities to a consolidated participants can readily choose to send transaction reporting plan for the month for which their orders to other exchange and off- 3 See Cboe Global Markets, U.S. Equities Market the fees apply. Volume Summary, Month-to-Date (April 26, 2021), 10 15 U.S.C. 78f. exchange venues if they deem fee levels available at https://markets.cboe.com/us/equities/ 11 15 U.S.C. 78f(b)(4). market_statistics/. 12 15 U.S.C. 78f(b)(5). 13 See supra note 3.

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at those other venues to be more investors, or otherwise in furtherance of Number SR–CboeEDGA–2021–012 and favorable. Moreover, the Commission the purposes of the Act. If the should be submitted on or before June has repeatedly expressed its preference Commission takes such action, the 2, 2021. for competition over regulatory Commission will institute proceedings For the Commission, by the Division of intervention in determining prices, to determine whether the proposed rule Trading and Markets, pursuant to delegated products, and services in the securities change should be approved or authority.18 markets. Specifically, in Regulation disapproved. J. Matthew DeLesDernier, NMS, the Commission highlighted the IV. Solicitation of Comments Assistant Secretary. importance of market forces in [FR Doc. 2021–09970 Filed 5–11–21; 8:45 am] determining prices and SRO revenues Interested persons are invited to and, also, recognized that current submit written data, views, and BILLING CODE 8011–01–P regulation of the market system ‘‘has arguments concerning the foregoing, been remarkably successful in including whether the proposed rule change is consistent with the Act. SECURITIES AND EXCHANGE promoting market competition in its COMMISSION broader forms that are most important to Comments may be submitted by any of investors and listed companies.’’ 14 The the following methods: [Release No. 34–91798; File No. SBSDR– fact that this market is competitive has Electronic Comments 2020–01] also long been recognized by the courts. • In NetCoalition v. Securities and Use the Commission’s internet Security-Based Swap Data Exchange Commission, the D.C. Circuit comment form (http://www.sec.gov/ Repositories; DTCC Data Repository rules/sro.shtml); or stated as follows: ‘‘[n]o one disputes • (U.S.), LLC; Order Approving that competition for order flow is Send an email to rule-comments@ Application for Registration as a ‘fierce.’ . . . As the SEC explained, ‘[i]n sec.gov. Please include File Number Security-Based Swap Data Repository SR–CboeEDGA–2021–012 on the the U.S. national market system, buyers subject line. and sellers of securities, and the broker- May 7, 2021. dealers that act as their order-routing Paper Comment I. Introduction agents, have a wide range of choices of • Send paper comments in triplicate On December 22, 2020, DTCC Data where to route orders for execution’; to Secretary, Securities and Exchange [and] ‘no exchange can afford to take its Repository (U.S.), LLC (‘‘DDR’’) filed Commission, 100 F Street NE, with the Securities and Exchange market share percentages for granted’ Washington, DC 20549–1090. because ‘no exchange possesses a Commission (‘‘Commission’’) an All submissions should refer to File application (the ‘‘DDR Application’’) on monopoly, regulatory or otherwise, in Number SR–CboeEDGA–2021–012. This the execution of order flow from broker Form SDR to register as a security-based file number should be included on the swap data repository (‘‘SDR’’) pursuant dealers’ . . . .’’.15 Accordingly, the subject line if email is used. To help the to Section 13(n)(1) of the Securities Exchange does not believe its proposed Commission process and review your Exchange Act of 1934 (‘‘Exchange Act’’) fee change imposes any burden on comments more efficiently, please use and 17 CFR 240.13n–1 (‘‘Rule 13n–1’’) competition that is not necessary or only one method. The Commission will thereunder,1 and as a securities appropriate in furtherance of the post all comments on the Commission’s purposes of the Act. information processor (‘‘SIP’’) under internet website (http://www.sec.gov/ Section 11A(b) of the Exchange Act.2 C. Self-Regulatory Organization’s rules/sro.shtml). Copies of the DDR intends to operate as a registered Statement on Comments on the submission, all subsequent SDR for security-based swap (‘‘SBS’’) Proposed Rule Change Received From amendments, all written statements transactions in the equity, credit, and Members, Participants, or Others with respect to the proposed rule interest rate derivatives asset classes.3 The Exchange neither solicited nor change that are filed with the The Commission published notice of received comments on the proposed Commission, and all written the DDR Application in the Federal rule change. communications relating to the Register for public comment on proposed rule change between the February 10, 2021,4 and the III. Date of Effectiveness of the Commission and any person, other than Proposed Rule Change and Timing for those that may be withheld from the 18 17 CFR 200.30–3(a)(12). Commission Action public in accordance with the 1 15 U.S.C. 78m(n)(1); 17 CFR 240.13n–1. A copy The foregoing rule change has become provisions of 5 U.S.C. 552, will be of DDR’s application on Form SDR and non- available for website viewing and confidential exhibits thereto are available for public effective pursuant to Section 19(b)(3)(A) viewing on the Commission’s website. In 2016, DDR of the Act 16 and paragraph (f) of Rule printing in the Commission’s Public submitted a prior application for registration as an 19b–4 17 thereunder. At any time within Reference Room, 100 F Street NE, SDR. See Release No. 34–78216 (June 30, 2016), 81 60 days of the filing of the proposed rule Washington, DC 20549, on official FR 44379 (July 7, 2016); Release No. 34–81302 business days between the hours of (Aug. 3, 2017), 82 FR 37276 (Aug. 9, 2017). DDR change, the Commission summarily may withdrew this prior application in 2018. See Letter temporarily suspend such rule change if 10:00 a.m. and 3:00 p.m. Copies of the from Chris Childs, Managing Director, DDR, Mar. it appears to the Commission that such filing also will be available for 27, 2018, https://www.sec.gov/divisions/marketreg/ action is necessary or appropriate in the inspection and copying at the principal sdr/dtcc-sdr-application-withdrawal-letter- office of the Exchange. All comments 032718.pdf. public interest, for the protection of 2 received will be posted without change. 15 U.S.C. 78k–1(b). 3 DDR has included the interest rate asset class in 14 See Securities Exchange Act Release No. 51808 Persons submitting comments are its application based on feedback from potential (June 9, 2005), 70 FR 37496, 37499 (June 29, 2005). cautioned that we do not redact or edit users of its SDR services. The potential users have 15 NetCoalition v. SEC, 615 F.3d 525, 539 (D.C. personal identifying information from identified certain types of transactions that will be Cir. 2010) (quoting Securities Exchange Act Release comment submissions. You should reported through DDR’s infrastructure for interest No. 59039 (December 2, 2008), 73 FR 74770, 74782– rate derivatives as falling within the Exchange Act 83 (December 9, 2008) (SR–NYSEArca–2006–21)). submit only information that you wish definition of an SBS transaction. 16 15 U.S.C. 78s(b)(3)(A). to make available publicly. All 4 Release No. 34–91071 (Feb. 5, 2021), 86 FR 8977 17 17 CFR 240.19b–4(f). submissions should refer to File (Feb. 10, 2021) (‘‘DDR Notice’’).

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Commission received in response two public dissemination of security-based able to: (i) Assure the prompt, accurate, comment letters from the International swap transactions.10 Among other and reliable performance of its functions Swaps and Derivatives Association, Inc. things, Regulation SBSR requires each as an SDR; (ii) comply with any (‘‘ISDA’’).5 While generally supportive registered SDR to register with the applicable provisions of the securities of the DDR Application, ISDA Letter II Commission as a SIP,11 and the Form laws and the rules and regulations includes three requests related to SDR constitutes an application for thereunder; and (iii) carry out its regulatory reporting and public registration as a SIP, as well as an functions in a manner consistent with dissemination, which are addressed in SDR.12 the purposes of Section 13(n) of the Part III.G. As discussed in Parts III and In 2019, the Commission stated that Exchange Act and the rules and IV below, the Commission has carefully implementation of the SBS Reporting regulations thereunder.17 The reviewed the DDR Application and the Rules can and should be done in a Commission shall deny the registration comments received. This order grants manner that carries out the fundamental of an SDR if it does not make any such DDR’s application to register as an SDR policy goals of the SBS Reporting Rules finding.18 Similarly, to be registered in the asset classes noted above, and as while minimizing burdens as much as with the Commission as a SIP, the a SIP. practicable.13 Noting ongoing concerns Commission must find that such among market participants about II. Background applicant is so organized, and has the incurring unnecessary burdens and the capacity, to be able to assure the A. SDR Registration, Duties, and Core Commission’s efforts to promote prompt, accurate, and reliable Principles harmonization between the SBS performance of its functions as a SIP, Section 13(n) of the Exchange Act Reporting Rules and swap reporting comply with the provisions of the makes it unlawful for any person, unless rules, the Commission took the position Exchange Act and the rules and registered with the Commission, that, for four years following Regulation regulations thereunder, carry out its directly or indirectly, to make use of the SBSR’s Compliance Date 1 in each asset functions in a manner consistent with mails or any means or instrumentality of class,14 certain actions with respect to the purposes of the Exchange Act, and, interstate commerce to perform the the SBS Reporting Rules would not insofar as it is acting as an exclusive functions of an SDR.6 To be registered provide a basis for a Commission processor, operate fairly and and maintain registration, an SDR must enforcement action.15 The no-action efficiently.19 comply with certain requirements and statement’s relevance to DDR’s In determining whether an applicant core principles described in Section application for registration as an SDR meets the criteria set forth in Rule 13n– 13(n), as well as any requirements that and SIP is discussed further below. 1(c), the Commission will consider the information reflected by the applicant the Commission may impose by rule or B. Standard for Registration regulation.7 In 2015, the Commission on its Form SDR, as well as any As noted above, to be registered with adopted 17 CFR 240.13n–1 to 13n–12 additional information obtained from the Commission as an SDR and under the Exchange Act to establish the applicant. For example, Form SDR maintain such registration, an SDR is Form SDR, the procedures for requires an applicant to provide a list of required to comply with the registration as an SDR, and the duties the asset classes for which the applicant requirements and core principles and core principles applicable to an is collecting and maintaining data or for described in Section 13(n) of the SDR (‘‘SDR Rules’’).8 The Commission which it proposes to collect and Exchange Act, as well as with any provided a temporary exemption from maintain data, a description of the requirement that the Commission may compliance with the SDR Rules and also functions that it performs or proposes to impose by rule or regulation.16 In extended exemptions from the perform, general information regarding addition, Rule 13n–1(c)(3) under the provisions of the Dodd-Frank Act set its business organization, and contact Exchange Act provides that the 20 forth in a Commission order providing information. Obtaining this Commission shall grant the registration temporary exemptions and other information and other information of an SDR if it finds that the SDR is so temporary relief from compliance with reflected on Form SDR and the exhibits organized, and has the capacity, to be certain provisions of the Exchange Act thereto—including the applicant’s concerning security-based swaps, and overall business structure, financial 10 Release No. 34–74244 (Feb. 11, 2015), 80 FR condition, track record in providing these temporary exemptions expired in 14563 (Mar. 19, 2015); Release No. 34–78321 (July 2017.9 14, 2016), 81 FR 53546 (Aug. 12, 2016) (‘‘Regulation access to its services and data, The Commission also has adopted 17 SBSR Adopting Release’’). Regulation SBSR and the technological reliability, and policies CFR 242.900 to 909 under the Exchange SDR Rules are referred to collectively as the ‘‘SBS and procedures to comply with its Act (collectively, ‘‘Regulation SBSR’’), Reporting Rules.’’ statutory and regulatory obligations— 11 See 17 CFR 242.909. will enable the Commission to which governs regulatory reporting and 12 See Form SDR, Instruction 2. determine whether to grant or deny an 13 Release No. 34–87780 (Dec. 18, 2019), 85 FR 21 5 Letters from Eleanor Hsu, Director, Data and 6270, 6347 (Feb. 4, 2020) (‘‘ANE Adopting application for registration. Reporting, ISDA, dated Feb. 26, 2021 (‘‘ISDA Letter Release’’). Furthermore, the information requested I’’) and Apr. 9, 2021 (‘‘ISDA Letter II’’). ISDA Letter 14 See id. Under Regulation SBSR, the first in Form SDR will enable the I did not address the substance of the DDR compliance date (‘‘Compliance Date 1’’) for affected Commission to assess whether the Application; ISDA Letter II provided comments that persons with respect to an SBS asset class is the are discussed below. first Monday that is the later of: (i) Six months after applicant is so organized and has the 6 15 U.S.C. 78m(n). the date on which the first SDR that can accept capacity to comply and carry out its 7 Id. transaction reports in that asset class registers with functions in a manner consistent with 8 See Release No. 34–74246 (Feb. 11, 2015), 80 FR the Commission; or (ii) one month after the the federal securities laws and the rules 14438, 14438 (Mar. 19, 2015) (‘‘SDR Adopting compliance date for registration of SBS dealers and Release’’). In 2016, the Commission subsequently major SBS participants (‘‘SBS entities’’). Id. at 6346. 17 amended 17 CFR 240.13n–4 to address third-party The compliance date for registration of SBS entities 17 CFR 240.13n–1(c)(3). regulatory access to SBS data obtained by an SDR. is October 6, 2021. See id. at 6270, 6345. 18 Id. See Release No. 34–78716 (Aug. 29, 2016), 81 FR 15 See id. The specific rule provisions of the SBS 19 See 15 U.S.C. 78k–1(b)(3). 60585 (Sep. 2, 2016). Reporting Rules affected by the no-action statement 20 See SDR Adopting Release, supra note 8, at 9 See Release No. 34–80359 (Mar. 31, 2017), 82 FR are discussed in Part II.B. 14459. 16867 (Apr. 6, 2017). 16 See 15 U.S.C. 78m(n)(3). 21 See id. at 14458.

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and regulations thereunder, including III. Review of DDR’s Application Under of the Board and effected by a majority the SBS Reporting Rules.22 SBS Reporting Rules vote.35 The CCO is responsible for Consistent with the Commission’s no- As noted above, DDR intends to establishing and administering the action statement in the ANE Adopting operate as a registered SDR for the compliance program that is designed to prevent violations of the obligations of Release,23 an entity wishing to register equity, credit, and interest rate a swap data repository under the Dodd- with the Commission as an SDR must derivatives asset classes.28 In its application, DDR represents that it is Frank Act and other applicable still submit an application on Form regulations and is ultimately SDR, but can address the rule provisions provisionally registered with the CFTC as a swap data repository, is in responsible for ensuring that DDR included in the no-action statement by complies with the requirements of the discussing how the SDR complies with compliance with applicable requirements under the CFTC reporting Commodity Exchange Act, the comparable Commodity Futures Trading rules applicable to a registered swap Securities Exchange Act and other Commission (‘‘CFTC’’) requirements.24 36 data repository, and intends to rely on applicable laws and regulations. The Accordingly, in such instances the the Commission’s position outlined in CCO has oversight over all compliance Commission will not assess an SDR the ANE Adopting Release for functions and staff related to DDR’s 37 application for consistency or applicable reporting rules and SBSDR compliance program. The duties of the compliance with the rule provisions duties for the period set forth therein.29 CCO include, but are not limited to, the included in the Commission’s no-action Below is a review of the representations following: (a) Oversee and review DDR’s statement. Specifically, the Commission made in the application materials compliance with applicable law in identified the following provisions as against the SBS Reporting Rules, taking jurisdictions where DDR is registered, not providing a basis for an enforcement into account DDR’s reliance on the designated, recognized or otherwise action against a registered SDR for the Commission’s position outlined in the licensed; (b) in consultation with the duration of the relief provided in the ANE Adopting Release. DDR Board or the Senior Officer, resolve any conflicts of interests that may arise, Commission statement: Under A. Organization and Governance Regulation SBSR, aspects of 17 CFR including, but not limited to, conflicts between business considerations and 242.901(a), 901(c)(2) through (7), 901(d), 1. Summary of DDR’s Application compliance requirements, conflicts 901(e), 902, 903(b), 906(a) and (b), and DDR is a New York limited liability between business considerations and 907(a)(1), (a)(3), and (a)(4) through (6); company and a wholly owned compliance requirements for fair and under the SDR Rules, aspects of Section subsidiary of DTCC Deriv/SERV LLC open access, and conflicts between the 13(n)(5)(B) of the Exchange Act and 17 (‘‘Deriv/SERV’’), which in turn is a management and members of the DDR CFR 240.13n–4(b)(3) thereunder, and wholly owned subsidiary of The Board; (c) establish and administer aspects of 17 CFR 240.13n–5(b)(1)(iii); Depository Trust & Clearing Corporation written policies and procedures 30 and under Section 11A(b) of the (‘‘DTCC’’). DDR is governed by a board reasonably designed to prevent violation 31 Exchange Act, any provision pertaining of directors (‘‘DDR Board’’). The of law; (d) take reasonable steps to to SIPs.25 Thus, an SDR applicant will number of directors on the DDR Board ensure compliance with applicable law not need to include materials in its is determined by Deriv/SERV as the sole relating to agreements, contracts or 32 application explaining how it would LLC member of DDR. The DDR Board transactions and confidentiality comply with the provisions noted is composed of individuals selected agreements entered into with foreign or from the following groups: Employees of above, and could instead rely on its domestic regulators; (e) establish DDR’s users (either fees paying users or procedures for the remediation of non- discussion about how it complies with end users) with derivatives industry 26 compliance issues identified by the CCO comparable CFTC requirements. The experience, buy-side representatives, applicant may instead represent in its through a compliance office review, independents, and members of senior look-back, internal or external audit application that it: (i) Is registered with management or the Board of DTCC.33 the CFTC as a swap data repository; (ii) finding, self-reported error, or validated The Deriv/SERV Nominations complaint; (f) notify the DDR Board as is in compliance with applicable Committee shall periodically review the soon as practicable upon becoming requirements under the swap reporting composition of the DDR Board to assure aware of a circumstance indicating that rules; (iii) satisfies the standard for that the level of representation of DDR, or an individual acting on its Commission registration of an SDR directors from users, management and behalf, is in non-compliance with the under Rule 13n–1(c); and (iv) intends to non-users is appropriate for the interests applicable laws of a jurisdiction in 34 rely on the no-action statement included of these constituencies in DDR. which it operates and either: (1) The in the ANE Adopting Release for the In addition, the DDR Board is non-compliance creates a risk to a user; period set forth in the ANE Adopting responsible for the appointment and (2) the non-compliance creates a risk of Release with respect to any SBS asset removal of the chief compliance officer harm to the capital markets in which it class or classes for which it intends to (‘‘CCO’’) and approval of CCO operates; (3) the non-compliance is part accept transaction reports.27 compensation, which is at the discretion of a pattern of non-compliance; or (4) the non-compliance may have an impact 28 See DDR Rulebook, Ex. HH, sec. 3.1; see also on DDR’s ability to carry on business as 22 See id. at 14458–59. Disclosure Document, Ex. D6, sec. 1. 29 a trade repository in compliance with 23 See supra notes 13–15 and accompanying text. See Form SDR, cover letter from Katherine Delp, General Manager, DTCC Data Repository applicable law; (g) establish and follow 24 See supra note 15. (U.S.) LLC. 25 The ANE Adopting Release provides additional appropriate procedures for the handling, 30 DDR Rulebook, Ex. HH, sec. 2.1. discussion of the particular aspects of the affected management response, remediation, 31 Id. at sec. 2.2. Defined terms taken from the retesting and closing of noncompliance rules that would not provide a basis for an DDR Application and used or summarized in this enforcement action. See ANE Adopting Release, order are intended to have the same meaning as in issues; (h) establish and administer a supra note 13, at 6347–48. DDR Application. 26 Id. at 6348. 32 Id. 35 Id. at sec. 2.3. 27 Id. For example, an applicant need not describe 33 Id. 36 Ex. P. in Exhibit S its functions as a SIP. 34 Id. 37 Id.

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written code of ethics; and (i) prepare process for nominating directors and of any person involved in such conflict and sign an annual compliance report in with the right to petition for alternative from such decision-making; and (iii) accordance with applicable regulations candidates; and (iv) establish, maintain, establish, maintain, and enforce written and associated recordkeeping.38 In and enforce written policies and policies and procedures regarding the addition, the application provides that procedures reasonably designed to SDR’s non-commercial and/or the CCO or a delegate thereof has the ensure that senior management and commercial use of the SBS transaction authority to investigate any potential each member of the board or committee information that it receives.52 rule violation and is responsible for that has authority to act on behalf of the The Commission received no enforcing sanctions related to violations board possess requisite skills and comments applicable to these and for following the procedures expertise to fulfill their responsibilities requirements. As described above, the outlined for DDR system restrictions.39 in the management and governance of DDR Application includes provisions The CCO, in consultation with the the SDR, have a clear understanding of for the representation of market DDR Audit Committee, will resolve all their responsibilities, and exercise participants in the governance conflicts of interest.40 Any conflict of sound judgment about the SDR’s arrangements, as well as procedures interest not resolved by the DDR Audit affairs.47 providing an opportunity to participate Committee shall be escalated to the DDR Furthermore, Rule 13n–4(b)(11) in the process for nominating directors Board for resolution.41 When resolving requires an SDR to designate an and the right to petition for alternative conflicts of interest involving DDR staff, individual to serve as CCO, and Rule candidates. In addition, the DDR the DDR CCO, DDR’s senior officer, the 13n–11(a) requires the SDR to identify Application includes policies and audit committee, and the DDR Board on Form SDR the person so procedures that set standards for the consider all relevant facts and designated.48 Rule 13n–11(a) also skills and expertise possessed by the circumstances.42 With regard to director requires that the compensation, DDR Board. conflicts of interest, the application appointment, and removal of the CCO More generally, the DDR Application provides that a director conflict is shall require approval of a majority of sets forth an organizational structure present whenever the interests of DDR the SDR’s board of directors.49 Rule that is clear and includes provisions for compete with the interests of a director 13n–11(c) requires the CCO to: (i) internal controls. The DDR Application or any party associated with a Report directly to the board of directors includes provisions for a CCO that has director.43 The application also or to the senior officer; (ii) review been designated by the DDR Board and provides that a director conflict is compliance with Section 13(n) of the whose compensation, appointment, and present whenever a director’s corporate Exchange Act and the rules thereunder; removal is set by the DDR Board. In or personal interests could be (iii) in consultation with the board or addition, the DDR Application includes reasonably viewed as affecting his or her the senior officer, take reasonable steps policies and procedures that require the objectivity or independence in fulfilling to resolve any material conflicts of CCO to report to the senior officer and his or her duties.44 According to the interest; (iv) be responsible for be responsible for maintaining application materials, DDR expects its administering the policies and compliance with applicable directors to act ‘‘on the side of caution’’ procedures required by Section 13(n) of Commission rules, investigating any and immediately bring to the attention the Exchange Act and the rules suspected violations thereof, and of the DDR CCO and either the Board thereunder; (v) take reasonable steps to overseeing any necessary remediation. Chairman or DDR’s legal counsel any ensure compliance with the Exchange The DDR Application includes policies matters involving conflicts of interest.45 Act and the SDR Rules thereunder; (vi) and procedures that identify and mitigate conflicts of interest, require the 2. Discussion establish procedures for the remediation of noncompliance; and (vii) establish recusal from decision-making of Section 13(n)(7)(B) of the Exchange and follow appropriate procedures for members of the DDR Board when Act and Rule 13n–4(c)(2) thereunder the handling, management response, involved in a conflict, and delineate the require an SDR to establish governance remediation, retesting, and closing of commercial and non-commercial use of arrangements that are transparent to noncompliance issues.50 SBS transaction information received. fulfill public interest requirements and Additionally, Section 13(n)(7)(C) of B. Access and Information Security to support the objectives of the Federal the Exchange Act requires an SDR to Government, owners, and establish and enforce rules to minimize 1. Summary of DDR’s Application 46 participants. In addition, Rule 13n– conflicts of interest in the decision- According to DDR, access to and 4(c)(2) requires an SDR to (i) establish making process of the SDR and establish usage of its SDR service will be well-defined governance arrangements a process for resolving any such available to all market participants that that include a clear organizational conflicts of interest.51 Rule 13n–4(c)(3) engage in SBS transactions, and DDR structure with effective internal under the Exchange Act provides that does not and will not bundle or tie its controls; (ii) establish governance an SDR must: (i) Establish, maintain, SDR services with any other services.53 arrangements that provide for fair and enforce written policies and The application provides that DDR’s representation of market participants; procedures reasonably designed to services would be available to all market (iii) provide representatives of market identify and mitigate potential and participants on a fair, open, and equal participants, including end-users, with existing conflicts of interest in the SDR’s basis.54 Further, DDR does not impose the opportunity to participate in the decision-making process on an ongoing membership qualifications on users of its services beyond (i) requiring 38 basis; (ii) with respect to the decision- DDR Rulebook, Ex. HH, sec. 2.3. execution of membership documents, 39 Id. at sec. 10.5. making process for resolving any 40 Id. at sec. 11.1. conflicts of interest, require the recusal such as a user agreement, (ii) the ability 41 Id. to comply with the technical 42 Id. 47 17 CFR 240.13n–4(c)(2)(i)–(iv). specifications published by DDR, and 43 Id. at sec. 11.2. 48 17 CFR 240.13n–4(b), 13n–11(a). 44 Id. 49 17 CFR 240.13n–11(a). 52 17 CFR 240.13n–4(c)(3)(i)–(iii). 45 Id. at sec. 11.3. 50 17 CFR 240.13n–11(c)(1)–(7). 53 See DDR Rulebook, Ex. HH, at sec. 1.1. 46 15 U.S.C 78m(n)(7)(B); 17 CFR 240.13n–4(c)(2). 51 15 U.S.C. 78m(n)(7)(C)(i), (ii). 54 See id.

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(iii) compliance with applicable law, DDR’s system, or any other matter with all costs incurred by DDR in specifically those related to sanctions directly relating to such user that is not connection with a ‘‘Subject Event’’ and administered and enforced by the Office the responsibility of DDR under the apply any deterrent financial penalties of Foreign Assets Control of the U.S. DDR Operating Procedures, except to that DDR may deem necessary.69 The Department of the Treasury (‘‘OFAC’’).55 the extent that such losses arise out of DDR Rulebook provides that DDR is To be granted access to the DDR or relate to DDR’s negligence or willful required to provide prompt notice to the system, receive trade information, misconduct.62 designated regulators of any such confirm or verify transactions, submit With respect to prohibiting or limiting action,70 as well as furnish the user with messages, or receive reports, a market a person’s access to SDR services, the a concise written statement describing participant must be onboarded as a DDR Rulebook outlines the process the Subject Event applicable to the user.56 For those market participants required for DDR to decline an user.71 that onboard, DDR will provide a application to become a user of SDR With respect to information security, mechanism for users to access the DDR services.63 For example, DDR may deny the DDR Rulebook provides that DTCC system to confirm and verify an applicant’s access to the DDR system has established a Technology Risk transactions. Users are required to if required pursuant to applicable law Management Team, whose role is to maintain at least two Super Access (e.g., due to sanctions administered and manage information security risk and Coordinators (‘‘SuperACs’’) on the DDR enforced by OFAC or the Canadian ensure the availability, integrity, and System; SuperACs are responsible for: Government’s Office of the confidentiality of the organization’s (1) Providing access to other individuals Superintendent of Financial information assets.72 DDR will be (referred to as ‘‘ACs’’) who are eligible Institutions).64 The DDR Rulebook responsible for monitoring the to access the System and use the SDR provides that any such applicants performance of DTCC regarding Services on behalf of the user; and (2) would receive notice and an implementation and maintenance of removing access for any individuals opportunity for a hearing in the event information security ‘‘within its who should no longer access the System that DDR declines an application.65 The infrastructure.’’ 73 The DDR Rulebook on behalf of the user.57 DDR Rulebook also provides that, if the specifies that various policies have been To participate in the SDR services denial of an application is reversed,66 developed to provide the framework for offered by DDR, each user will be such application will be accepted and both physical security and information required to enter into a user agreement; the applicant granted access to the DDR security are routinely refreshed.74 It also by entering into a user agreement each system following completion of states that DDR’s Technology Risk user agrees to be bound by the terms of onboarding requirements.67 Management Team carries out a series of the user agreement and DDR Operating The DDR Rulebook also provides that processes to endeavor to ensure that Procedures, which incorporate terms of DDR may temporarily deny access to or DDR is protected in a cost-effective and DDR’s Rulebook.58 In addition, the DDR otherwise impose restrictions on the use comprehensive manner, while still Rulebook provides that each user must of the DDR system on a user, or take meeting the requirements of applicable 75 comply with all reasonable requests by such other actions as DDR deems regulations. This includes preventive DDR for information, documentation, or reasonably necessary to protect its controls such as firewalls, appropriate data concerning such user and related to systems and other users, for (i) a encryption technology, and 76 such user’s use of the DDR system as violation of the DDR rules (including a authentication methods. Vulnerability DDR may deem necessary.59 The DDR failure to pay fees when due); (ii) any scanning is used to identify high risks Rulebook also states that DDR has the neglect or refusal by such user to to be mitigated and managed and to right to audit or inspect a user (and its comply with any direction DDR deems measure conformance against the 77 facilities) with respect to its use of the reasonably necessary to protect its policies and standards. systems and other users; or (iii) any The DDR system is supported by DDR system, upon reasonable notice.60 error, delay, or other conduct that DTCC and relies on the disaster Furthermore, the DDR Rulebook materially and adversely affects the recovery program maintained by provides that users must cooperate with operations of DDR (each a ‘‘Subject DTCC.78 To enable DDR to provide such audits or inspections and with Event’’).68 Limits to the activities, timely resumption of critical services other inquiries by DDR concerning their functions, or operation of users may should there be any disruption to its use of the DDR system.61 include, but are not limited to, business, DDR follows these key The DDR Operating Procedures restricting access to the DDR system or principles for business continuity and provide that each user agrees to defend a user’s ability to submit data via a non- disaster recovery: (i) Achieve recovery and indemnify DDR from and against all approved source and assessing users of critical services within a four-hour reasonable losses, liabilities, damages, window with faster recovery time in judgments, settlements, fines, costs, and 62 Id., app. A, at sec. 9. less extreme situations; (ii) disperse staff expenses DDR may incur directly 63 See DDR Rulebook, Ex. HH, sec. 10.2. across geographically diverse operating arising out of or directly relating to the 64 See id. acts or omissions of a user’s 65 See id. 69 See id. 66 participation or failure to participate The DDR Notice, supra note 4, inadvertently 70 See id. misstated a provision in the DDR Rulebook. (for itself or on behalf of others) in 71 See id. at sec. 10.4.2 (setting out DDR’s Specifically, the DDR Rulebook does not include procedures for restrictive proceedings, including DDR’s services or DDR’s system, any language that states denial of an application could the user’s response to the Subject Event written unauthorized access to DDR’s system be reversed ‘‘either by the DDR Board or by the statement, the user’s opportunity for a hearing, and Commission pursuant to Section 11A(b) of the through such user’s interface with the user’s right to apply for review to the DDR Exchange Act.’’ As noted in Part II.B, the Board). Commission has identified Section 11A(b) as not 55 See id. 72 providing a basis for an enforcement action against Id. at sec. 9.2. 56 73 See id. a registered SDR for the duration of the relief Id. at sec. 9.1. 57 Id. at sec. 1.2. provided in the Commission statement in the ANE 74 Id. at sec. 9.2. 58 Id. at sec. 1.3. Adopting Release. See supra note 25 and 75 Id. 59 Id. at sec. 10.5. accompanying text. 76 Id. 60 Id. 67 See DDR Rulebook, Ex. HH, sec. 10.2. 77 Id. 61 Id. 68 See id. at sec. 10.4.1. 78 See id. at sec. 8.1.

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facilities; (iii) operate multiple back-up clear and specific minimum standards the user(s) to correct and re-submit.89 data centers linked by a highly resilient for users to follow in seeking to access According to DDR, its SDR service offers network technology; (iv) maintain SBS data held at the SDR. The DDR an end-to-end straight through process. emergency command and out-of-region Application also includes reasonable DDR states that, from the receipt of data, operating control; (v) utilize new provisions for limiting, denying, and processing and maintenance of data, technology which provides high- revoking access to SDR systems that and dissemination of data, processes are volume, high-speed, asynchronous data include procedures for review and automated and do not require manual transfer over distances of 1,000 miles or reconsideration of any determination intervention, and this straight through more; (vi) maintain processes that related to limiting, denying, or revoking processing model is a key mitigant to mitigate marketplace, operational and a user’s access. The Commission modification or invalidation of any cyber-attack risks; (vii) test continuity believes that the procedures described data.90 plan readiness and connectivity on a above further help ensure that the DDR’s Operating Procedures provides regular basis ensuring that users and access requirements are fair, open, and that DDR and each user agrees that each third-party vendors/service providers not unreasonably discriminatory. In will treat as confidential (both during can connect to DDR’s primary and back- addition, the DDR Application includes and after the termination of a user’s up sites; (viii) communicate on an policies and procedures designed to access to DDR’s system) all confidential emergency basis with the market, users ensure that the SDR’s automated information (defined as: (i) With respect and government agency decision- systems maintain adequate levels of to DDR, transaction data specified in makers; and (ix) evaluate, test, and capacity, integrity, resiliency, records received by DDR and any data, utilize best business continuity and availability, and security that protect reports, summaries or payment amounts resiliency practices.79 against loss of data, employ geographic which may be produced as a result of diversity in their site selection, and processing such transaction data, and 2. Discussion account for service disruptions. (ii) with respect to any user, the Rule 13n–4(c)(1)(ii) under the technical specifications of DDR’s system C. Acceptance and Use of SBS Data Exchange Act requires an SDR to permit (to the extent not publicly disclosed by market participants to access specific 1. Summary of DDR’s Application DDR; but confidential information does 80 services offered by the SDR separately. The DDR Application will provide not include data distributed to the Rule 13n–4(c)(1)(iii) requires an SDR to public in accordance will applicable market participants with the ability to 91 establish, monitor on an ongoing basis, submit data for over-the-counter law). and enforce clearly stated objective (‘‘OTC’’) derivatives for credit, equity, 2. Discussion criteria that would permit fair, open, rate, foreign exchange and other and not unreasonably discriminatory 84 Rule 13n–5(b)(1)(i) under the commodity asset classes. DDR may Exchange Act requires an SDR to access to services offered and data reject a transaction record submitted 81 establish, maintain, and enforce written maintained by the SDR. Rule 13n– due to the submission failing to meet 4(c)(1)(iv) requires an SDR to establish, policies and procedures reasonably DDR validations, including but not designed for the reporting of complete maintain, and enforce written policies limited to the submission failing to be and procedures reasonably designed to and accurate transaction data to the SDR in a format that can be ingested by DDR, and to accept all transaction data that is review any prohibition or limitation of failing to meet jurisdictional any person with respect to access to reported in accordance with such requirements or failing to provide policies and procedures.92 Additionally, services offered, directly or indirectly, required data elements.85 A rejected or data maintained by the SDR and to Rule 13n–5(b)(1)(ii) requires that if an submission is deemed not to have been SDR accepts any SBS transaction in a grant such person access to such submitted at all with respect to services or data if such person has been particular asset class, the SDR must reporting to the jurisdiction for which it accept all SBS transactions in that asset discriminated against unfairly.82 In was rejected (it is possible that one addition, Rule 13n–6 requires an SDR, class that are reported to it in transaction record is submitted to accordance with its policies and with respect to those systems that comply with reporting obligations in 93 support or are integrally related to the procedures. In addition, Rule 13n– more than one jurisdiction and accepted 5(b)(3) requires an SDR to establish, performance of its activities, to in one while rejected in another).86 establish, maintain, and enforce written maintain, and enforce written policies Upon submission, the DDR system will and procedures reasonably designed to policies and procedures reasonably perform validation checks to ensure that ensure that the transaction data and designed to ensure that its systems each submitted record is complete and positions that it maintains are complete provide adequate levels of capacity, accurate, in accordance DDR’s message and accurate.94 Rule 13n–5(b)(5) integrity, resiliency, availability, and 87 ingestion requirements. This process requires an SDR to establish, maintain, security.83 is completed through validation and and enforce written policies and The Commission received no 88 consistency checks. If the record fails procedures reasonably designed to comments applicable to these these validation or consistency checks, requirements. As described above, the prevent any provision in a valid SBS the record will be rejected, and such transaction from being invalidated or DDR Application includes procedures rejection status will be communicated to for onboarding and maintaining ongoing modified through the procedures or operations of the SDR.95 Rule 13n– access to users that are fair, open, 84 DDR Rulebook, Ex. HH, sec. 3.1; see also reasonable and not unreasonably Disclosure Document, Ex. D6, sec. 1. Although the 89 discriminatory. These procedures DDR Application concerns registration with the Id. Commission as an SDR for credit, equity, and 90 Ex. EE. include user agreements that reflect interest rate derivatives, as noted above, DDR is also 91 DDR Rulebook, Ex. HH, app. A, sec. 8; see also provisionally registered with the CFTC as a swap Disclosure Document, Ex. D6, sec. 5 (DDR’s privacy 79 See id. data repository. and confidentiality policies and procedures). 80 17 CFR 240.13n–4(c)(1)(ii). 85 DDR Rulebook, Ex. HH, sec. 1.3. 92 17 CFR 240.13n–5(b)(1)(i). 81 17 CFR 240.13n–4(c)(1)(iii). 86 Id. 93 17 CFR 240.13n–5(b)(1)(ii). 82 17 CFR 240.13n–4(c)(1)(iv). 87 Id. at sec. 10.1.1. 94 17 CFR 240.13n–5(b)(3). 83 17 CFR 240.13n–6. 88 Id. 95 17 CFR 240.13n–5(b)(5).

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5(b)(6) requires an SDR to establish levels of capacity, integrity, resiliency, increases on a tiered basis.103 Position procedures and provide facilities availability and security, as required count includes positions even if reasonably designed to effectively under Rule 13n–6; and (iii) ensure that terminated or exited prior to the month resolve disputes over the accuracy of the it protects the privacy and end.104 Platforms, as that term is transaction data and positions that are confidentiality of transaction defined by Commission rules,105 are not recorded in the SDR.96 information, as required under Rule charged position maintenance fees.106 Furthermore, Section 13(n)(5)(F) of 13n–9(b). Additionally, the DDR For a position where a clearing agency the Exchange Act and Rule 13n–4(b)(8) Application includes procedures (‘‘Clearer’’) is a counterparty, the Clearer thereunder each require an SDR to designed to ensure that any valid shall be responsible for the Position maintain the privacy of any and all SBS provisions of trade information are not Maintenance Fee, less a 75% transaction information that the SDR modified or invalidated, and these reduction.107 For all other positions, the receives.97 In addition, Rule 13n–9(b)(1) procedures include controls that are Reporting Side, as that term is defined requires an SDR to establish, maintain, regularly audited and processing by Commission rules,108 will be and enforce written policies and systems designed to prevent responsible for Position Maintenance procedures reasonably designed to unauthorized changes to SBS Fees.109 For entities grouped as a single protect the privacy of any and all SBS information. The Commission also account with subaccounts (‘‘Grouped transaction information that the SDR believes that DDR provides procedures Accounts’’), positions will be aggregated receives and that include policies and and facilities reasonably designed to for purposes of determining position procedures to protect the privacy of any effectively resolve disputes over the count threshold and to determine the and all SBS transaction information that accuracy of the transaction data and applicable tiered Position Maintenance the SDR shares with affiliates and non- positions that are recorded in the SDR. Fees.110 affiliated third parties.98 Rule 13n– Furthermore, the DDR Application In addition to the Position 9(b)(2) also requires an SDR to establish, contains policies and procedures Maintenance Fee, the application and maintain safeguards, policies, and regarding both data security and the indicates that DDR will charge an procedures reasonably designed to privacy of SBS data, the latter of which annual ‘‘Account Management Fee,’’ prevent the misappropriation or misuse, includes in each case procedures currently set at $1,200.00, that will directly or indirectly, of any limiting access to SBS data to apply to all accounts and will be confidential information received by the employees with either direct or support prorated in the year the account is 111 SDR, material non-public information, responsibilities related to systems that opened. Accounts may be set up on or intellectual property, such as trading maintain the data, and that limit the use an individual entity basis or, in certain strategies or portfolio positions, by: (i) of such data in all cases to the instances, as Grouped Accounts, such as 112 Limiting access to such information and performance of job responsibilities. The a corporate family that chooses to intellectual property; (ii) having Commission believes that such policies structure its account as a single account standards for trading by persons and procedures also establish a standard with subaccounts for affiliates or an associated with the SDR for their for the trading practices of personnel asset manager that chooses to structure personal benefit or the benefit of others; that prevents the use of the data for its account as a single account with and (iii) having adequate oversight to personal benefit or the benefit of others. subaccounts for its managed funds. ensure compliance with these Grouped Accounts will be charged one In addition, DDR has policies and 113 safeguards, policies, and procedures.99 procedures that, when taken together Account Management Fee. DDR’s fee policy further provides that The Commission received no with policies and procedures regarding users will have the option to elect to comments applicable to these the duties of the CCO,100 are reasonably enter into a long-term commitment for requirements. As described above, the designed to protect the privacy of SBS DDR Application includes policies and a period ending December 31, 2024 transaction information, including (‘‘Long Term Commitment’’), which procedures designed to protect information shared with affiliates and transaction data and its systems by would reduce the applicable Position third parties, through adequate Maintenance Fee and Account restricting access to users, who are oversight to ensure compliance with the obligated to comport with DDR’s rules policies and procedures described 103 The Position Maintenance Fees only apply for in a manner that facilitates DDR’s above. a position count of five hundred or more open compliance with its obligations under positions during any month. See id. For examples Commission rules. The Commission D. Fees of the calculation of the Position Maintenance Fee, views this approach as reasonable. 1. Summary of DDR’s Application see Annex A to Exhibit M of the application. Access to DDR’s systems to view trade 104 See Ex. M. 105 data or verify information should be The DDR Application includes DDR’s See 17 CFR 242.900(v) (defining ‘‘platform’’ as fee schedules.101 There are two types of a national securities exchange or security-based conditioned such that DDR retains the swap execution facility that is registered or exempt ability to protect the data, its systems, fees, Position Maintenance Fees and from registration). 102 and its users. The Commission notes Account Management Fees. DDR 106 See Ex. M. that DDR retains the responsibility, charges a monthly ‘‘Position 107 See id. 108 among other things, to ensure that its Maintenance Fee,’’ based on the number See 17 CFR 242.900(gg) (defining ‘‘reporting of positions open at any time during the side’’ as the side of a security-based swap identified policies and procedures are reasonably by Rule 901(a)(2) as having the duty to report the designed to: (i) Ensure trade data applicable month and which decreases transaction). reported to it is complete and accurate, as the number of open positions 109 See Ex. M. as required under Rule 13n–5(b)(1); (ii) 110 See id. ensure that its systems provide adequate 100 See supra Part III.A (describing policies and 111 See id. procedures regarding the CCO and conflicts of 112 DDR organizes its users into families (each, a interest). ‘‘Family’’) as directed by the users (through User 96 17 CFR 240.13n–5(b)(6). 101 See Ex. M. Additionally, DDR provides a fee Agreements or in such other manner as designated 97 See 15 U.S.C. 78m(n)(5)(F); 17 CFR 240.13n– schedule for DDR Users on its website at http:// by DDR from time to time) that desire to be so 4(b)(8), 240.13n–9. www.dtcc.com/derivatives-services/global-trade- organized. See DDR Rulebook, Ex. HH, app. A, sec. 98 17 CFR 240.13n–9. repository/gtr-us. 2. 99 See 17 CFR 240.13n–9(b)(2). 102 See Ex. M. 113 See Ex. M.

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Management Fee by ten percent, security-based swaps, which involve a registered or designated trade repository exclusive of tax, for the duration of the fixed cost investment and marginal it shall continue, for a period of not less Long-Term Commitment.114 If the Long costs of operation.120 The fixed than five years or upon transfer to the Term Commitment is terminated prior component of DDR’s fees would be Designated Regulator or its designee or to the end of the applicable Long Term consistent with the applicant recovering another registered or designated trade Commitment period, DDR explains that the fixed costs investment associated repository for that jurisdiction, to the non-Clearer User will be subject to with setting up and maintaining a user preserve, maintain, and make accessible an early termination fee equal to: (a) The account, while the variable component to each Designated Regulator or its difference between the total amount of would be consistent with the applicant designee, the records and data required fees due after application of the Long recovering marginal costs of operation, by Applicable Regulation in accordance Term Commitment incentive and the i.e., costs that increase with the with DDR’s Wind-Down Policies and total amount of fees that would have provision of SDR services to the user. Procedures document.125 been due during the applicable portion With regard to DDR’s fee schedule, 2. Discussion of the Long Term Commitment period which imposes an annual Account had no incentive been provided (‘‘Total Management Fee of $1,200 and a Rule 13n–5(b)(4) of the Exchange Act Incentive Provided’’); plus (b) the Positions Maintenance Fee that varies as requires an SDR to maintain transaction greater of five percent of the Total a function of the number of open data and related identifying information Incentive Provided or $500.00.115 positions each month, the fees are for not less than five years after the SBS identical to those charged to customers expires and historical positions for not 2. Discussion reporting swap transactions in credit, less than five years in a place and Section 13(n)(7)(A) of the Exchange equity, and interest rate products format that is readily accessible and Act prohibits an SDR (unless necessary pursuant to CFTC reporting rules and, usable to the Commission and other or appropriate to achieve the purposes as such, appear consistent with the persons with authority to access or view of the Exchange Act) from: (i) Adopting Commission’s own requirements.121 such information and in an electronic any rule or taking any action that results Specifically, the Commission believes it format that is non-rewriteable and non- in any unreasonable restraint of trade; or is reasonable for DDR to establish erasable.126 Rule 13n–7 requires an SDR (ii) imposing any material anti- similar fees across its CFTC and to make and keep current books and competitive burden on the trading, Commission reporting requirements records relating to its business for at clearing, or reporting of transactions.116 where its obligations require similar least five years, and for the first two Rule 13n–4(c)(1)(i) under the Exchange levels of services and infrastructure. The years, keep such records in a place that Act also requires an SDR to ensure that Commission believes that the DDR is immediately available to any dues, fees, or other charges that it Application sets fees at levels that are representatives of the Commission for imposes, and any discounts or rebates fair and reasonable and not inspection and examination.127 In that it offers, are fair and reasonable and unreasonably discriminatory. addition, Rule 13n–5(b)(8) requires an not unreasonably discriminatory.117 It SDR to make and keep current a plan to E. Recordkeeping also requires that such dues, fees, other ensure that the transaction data and charges, discounts, or rebates be applied 1. Summary of DDR’s Application positions that are recorded in the SDR consistently across all similarly situated The DDR Rulebook provides that DDR continue to be maintained in 118 128 users of the SDR’s services. In will maintain all information as accordance with Rule 13n–5(b)(7), discussing the fee provisions of the SDR required by applicable law as well as including procedures for transferring Rules, the Commission stated that it maintain swap and security-based swap the transaction data and positions to the 129 would take a flexible approach in data throughout the existence of the Commission or its designee. evaluating the fairness and swap and security-based swap and for The Commission received no reasonableness of an SDR’s fees and fifteen years following termination of comments applicable to these charges on a case-by-case basis, the swap or security-based swap or as requirements. As described above, the recognizing that there may be instances otherwise required by applicable DDR Application provides for the in which an SDR could charge different regulations.122 The records will be recordkeeping of SBS transaction data users different prices for the same or for at least five years following the 119 readily accessible throughout the life of 130 similar services. a swap or security-based swap and for termination of the transaction, and The Commission received no five years following its termination and will be readily accessible throughout the comments applicable to these shall be in an electronic format that is life of a security-based swap in an requirements. As described above, the non-rewriteable and non-erasable.123 electronic format that is non-rewriteable DDR Application describes fees that 131 For the remainder of the retention and non-erasable. In addition, DDR include a fixed component and a period, the swap or security-based swap provides for the transferring of variable component that increases with record will be retrievable within three the usage of SDR services. The 125 Id. business days.124 In the event DDR Commission notes that such a fee 126 17 CFR 240.13n–5(b)(4). ceases doing business or ceases to be a structure is generally in line with the 127 17 CFR 240.13n–7. economics of recordkeeping services for 128 Rule 13n–5(b)(7) states that, if an SDR ceases 120 See generally Regulation SBSR Adopting doing business or ceases to be registered pursuant Release, supra note 10, at 53551 (stating that the to Section 13(n) of the Exchange Act, the SDR must 114 See id. provision of recordkeeping services for security- continue to preserve, maintain, and make accessible 115 See id. based swaps involves a predominantly fixed cost the transaction data and historical positions 116 15 U.S.C. 78m(n)(7)(A). investment with low marginal costs of operation). required to be collected, maintained, and preserved 117 17 CFR 240.13n–3(c)(1)(i). 121 See DDR Fee Schedule—CFTC Reporting, Oct. by this section in the manner required by the ∼ 118 Id. 1, 2016, http://www.dtcc.com/ /media/Files/ Exchange Act and the rules and regulations 119 Downloads/Data-and-Repository-Services/GTR/US- thereunder and for the remainder of the period See SDR Adopting Release, supra note 8, at _ 14479. In making this statement, however, the DDR/DDR Fees.pdf. required by this section. 17 CFR 240.13n–5(b)(7). Commission also noted that charging different users 122 DDR Rulebook, Ex. HH, sec. 1.4.1. 129 17 CFR 240.13n–8. different prices for the same or similar services 123 Id. 130 See DDR Rulebook, Ex. HH, sec. 1.4.1. cannot be unreasonably discriminatory. 124 Id. 131 See id.

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transaction data and positions to the certain written information, which must requirement to furnish the document to Commission via reports designed to reasonably enable the market market participants, the Commission provide visibility into positions and the participant to identify and evaluate understands that DDR publishes similar status of submitted trades and also accurately the risks and costs associated disclosure documents on its website,142 provides for direct electronic access to with using the SDR’s services.135 This and anticipates the same for the DDR data reported to DDR in satisfaction of written information must contain the Disclosure Document relevant to this the Commission’s regulatory following: (i) The SDR’s criteria for application. requirements both for the Commission providing others with access to the G. Regulatory Reporting and Public and, where such access is permitted by services offered and data it maintains; Dissemination applicable law and any relevant (ii) its criteria for those seeking to Memorandum of Understanding or other connect to or link with the SDR; (iii) a As a registered SDR, DDR would carry arrangement, the Commission’s description of its policies and out an important role in the regulatory designee. procedures regarding its safeguarding of reporting and public dissemination of data and operational reliability, as SBS transactions. As noted above, DDR F. Disclosure described in Rule 13n–6; (iv) a stated that it intends to rely on the no- 1. Summary of DDR’s Application description of its policies and action statement included in the ANE Adopting Release for the period set forth DDR publishes a disclosure document procedures reasonably designed to in the ANE Adopting Release with to provide a summary of information protect the privacy of SBS transaction respect to SBS asset classes. Therefore, regarding its service offerings and the information that it receives, as described DDR was not required to include SBS data it maintains.132 Specifically, in Rule 13n–9(b)(1); (v) a description of materials in its application explaining the disclosure document sets forth a its policies and procedures regarding its how it would comply with the description of the following: (i) A noncommercial and commercial use of provisions of the SBS Reporting Rules description of access to services offered SBS transaction information that it noted in the no-action statement.143 and swap data maintained; (ii) criteria receives, as described in Rule 13n– Instead, DDR may rely on its discussion for those seeking to connect to or link 5(b)(6); (vi) a description of its dispute about how it complies with comparable with its SDR; (iii) criteria for those resolution procedures, as described in CFTC requirements pertaining to seeking to connect to or link with DDR Rule 13n–5(b)(6); (vii) a description of regulatory reporting and public systems; (iv) policies and procedures all the SDR’s services, including any ancillary services; and (viii) the SDR’s dissemination of swap transactions. with respect to DDR systems safeguards; In the no-action statement, the (v) policies and procedures related to updated schedule of any dues; unbundled prices, rates or other fees for Commission stated that an applicant privacy and confidentiality; (vi) policies ‘‘will not need to include materials in and procedures regarding its non- all of its services, including ancillary services; any discounts or rebates its application explaining how it would commercial and commercial use of comply with the provisions [specifically transaction data; 133 (vii) procedures for offered; and the criteria to benefit from such discounts or rebates; and (ix) a noted as not providing a basis for a dispute resolution; (viii) fees, rates, dues Commission enforcement action during and other charges; and (ix) governance description of its governance 136 the pendency of the statement].’’ 144 The arrangements.134 arrangements. The Commission received no applicant ‘‘could instead rely on its 2. Discussion comments applicable to these discussion about how it complies with 145 Rule 13n–10 under the Exchange Act requirements. As described throughout comparable CFTC requirements.’’ In requires that, before accepting any SBS this order, the DDR Application its application, DDR provided exhibits data from a market participant or upon includes extensive discussion of DDR’s that adapted its policies and procedures a market participant’s request, an SDR policies and procedures with respect to for regulatory reporting and public shall furnish to the market participant a access,137 the use of SBS transaction dissemination of swaps for use in the disclosure document that contains information,138 service offerings, SBS market. The Commission believes including ancillary services,139 and that, with respect to its role in the 140 132 See Disclosure Document, Ex. D6. governance arrangements. The regulatory reporting and public 133 See also DDR Rulebook, Ex. HH, sec. 6.3 (‘‘As Commission believes that the DDR dissemination of SBS transactions, DDR part of the SDR Services, DDR receives and collects Disclosure Document presents a has satisfied the approach described by swap and security-based swap data in the ordinary reasonably comprehensive view of the the Commission in the no-action course of its business from various Market Participants and registered entities for the purpose applicant’s overall service offering, from 142 of maintaining a centralized recordkeeping facility which a potential user could identify See, e.g., https://www.dtcc.com/-/media/Files/ for swaps and security-based swaps. The collection Downloads/Data-and-Repository-Services/GTR/US- and evaluate accurately the risks and DDR/DDR_Disclosure.pdf https://www.dtcc.com/-/ and maintenance of this data is designed to enhance costs associated with using the SDR’s the transparency, promote standardization and media/Files/Downloads/Data-and-Repository- 141 _ reduce systemic risk by making this data available services. In addition, regarding the Services/GTR/US-DDR/DDR Disclosure.pdf to regulators and the public pursuant to Applicable (publishing a disclosure document pursuant to CFTC requirements). Law. Therefore, access to data maintained by DDR 135 17 CFR 240.13n–10. 143 However, the DDR Application includes to Market Participants is generally prohibited, 136 See id. except to either counterparty to that particular swap provisions explaining how DDR would require 137 See supra Part III.B (describing policies and or security-based swap, such counterparty’s users to identify SBS, as required by Rule 901(c)(1) procedures with respect to access and information authorized third party service providers or other of Regulation SBSR. See Ex. HH2, sec. 4.4 security). parties specifically authorized by the User or (regarding Unique Product Identifiers). The DDR 138 counterparty pursuant to Rule 1.3 or 6.4, or to other See supra Part III.C (describing policies and Application also includes a provision explaining regulators or entities in accordance with Rule 6.5 procedures with respect to acceptance and use of how DDR would comply with a condition to the no- below. DDR shall not, as a condition of the SBS data). action statement included in the ANE Adopting reporting of swap or security-based swap 139 See supra Part III.D (describing policies and Release. See Ex. GG2, sec. 15.2.3.2 (providing, in transaction data, require a Reporting Party to procedures with respect to fees). the case of a credit security-based swap, for consent to the use of reported data for commercial 140 See supra Part III.A (describing policies and dissemination of a capped notional size of $5 or business purposes. DDR shall not make procedures with respect to governance million if the true notional size of the transaction commercial use of real-time swap data prior to its arrangements, the duties of the CCO, and conflicts is $5 million or greater). public dissemination.’’). of interest). 144 ANE Adopting Release, supra note 13, at 6348. 134 See id. 141 See DDR Disclosure Document, Ex. D6. 145 Id.

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statement regarding the information and immediately under Regulation SBSR, standard for registration previously representations sufficient to support its and ISDA therefore requests that the described in Part II.B,152 the approval for registration as an SDR and SEC align its requirement with the Commission has considered whether SIP.146 CFTC requirement.149 To the extent DDR is so organized, and has the ISDA Letter II included three requests ISDA is requesting that the Commission capacity, to be able to assure the with respect to the DDR Application. modify the no-action statement in prompt, accurate, and reliable First, ISDA stated that the DDR response to ISDA’s comment, the performance of its functions as a SIP, Rulebook should ‘‘discuss ‘Counterparty Commission declines to do so. comply with the provisions of the 2’ identifiers that will be permitted Furthermore, because this comment Exchange Act and the rules and under the new [CFTC] swap data pertains to a Commission position and regulations thereunder, carry out its reporting rules.’’ 147 To the extent that not to the DDR Application, it does not functions in a manner consistent with this suggestion involves changes to affect the Commission’s review of the the purposes of the Exchange Act, and, DDR’s systems, policies, and procedures DDR Application under the relevant insofar as it is acting as an exclusive for complying with future CFTC statutory standards for registration as an processor, operate fairly and efficiently. requirements, they are not part of DDR’s SDR and as a SIP.150 The Commission finds that DDR meets existing systems, policies, and these criteria for registration as a SIP for procedures and thus are not germane to IV. Evaluation of DDR’s Application and Commission Findings the reasons described throughout this the application being considered by the order. Commission. However, the Commission Consistent with the standard for expects that DDR will, in the future, registration previously described in Part V. Conclusion explain to its participants how changes II.B,151 the Commission has considered For the reasons discussed above, the made to the systems, policies, and whether DDR is so organized, and has Commission finds that DDR meets the procedures for complying with CFTC the capacity, to be able to assure the applicable requirements for registration swap data reporting requirements will prompt, accurate, and reliable as an SDR, including those standards set impact the reporting of security-based performance of its functions as an SDR, forth in Section 13(n) of the Exchange swap transactions. comply with any applicable provisions Act and Commission rules and Second, ISDA expressed support for of the securities laws and the rules and regulations thereunder, and the the approach to unique trade identifiers regulations thereunder, and carry out its applicable requirements for registration in the DDR Rulebook, but for clarity functions in a manner consistent with as a SIP under Section 11A(b) of the requested adding appropriate references the purposes of Section 13(n) of the Exchange Act. to the Unique Swap Identifier (‘‘USI’’) Exchange Act and the rules and It is hereby ordered that the required by CFTC rules.148 The no- regulations thereunder. The application for registration as a security- action statement in the ANE Adopting Commission finds that DDR meets these based swap data repository and a Release does not impose any obligations criteria for registration as an SDR for the securities information processor filed by on DDR to utilize a particular reasons described throughout this order. DTCC Data Repository (U.S.), LLC (File vocabulary when referring to data To evaluate DDR’s application to No. SBSDR–2020–01) pursuant to elements that will be utilized for both register as a SIP, and consistent with the Sections 13(n) and 11A(b) of the SEC and CFTC transaction reporting, so Exchange Act be, and hereby is, 149 this request does not affect the See id. at 5. approved. Commission’s evaluation of the DDR 150 Under the CFTC’s reporting rules, an SDR Application against the relevant must publicly disseminate swap transaction and By the Commission. pricing data as soon as technologically practicable Jill M. Peterson, statutory standards for registration as an after such data is received, unless such swap SDR and as a SIP. transaction and pricing data is subject to a time Assistant Secretary. Third, ISDA notes that, although the delay described in § 43.5, in which case the swap [FR Doc. 2021–10065 Filed 5–11–21; 8:45 am] transaction and pricing data shall be publicly specifications in the DDR Rulebook BILLING CODE 8011–01–P disseminated in the manner described in § 43.5. See ‘‘technically align’’ with the SEC 17 CFR 43.3(b)(1). In addition, Appendix C to Part requirement that an SDR publicly 43 provides clarification of the time delays for disseminate immediately upon receipt, public dissemination set forth in § 43.5. An SDR SUSQUEHANNA RIVER BASIN SDRs are also built to delay public subject to the CFTC’s Part 43 rules must disseminate transaction and pricing data with a COMMISSION dissemination under CFTC time delay if the transaction falls within § 43.5, and requirements. ISDA suggests that must disseminate transaction and pricing data ‘‘as Projects Approved for Consumptive complying with the SEC requirement soon as technologically practicable’’ if it does not. Uses of Water would require SDRs to incur the cost of The Commission’s no-action statement recognized adding functionality to disseminate that security-based swap transactions do not fall AGENCY: Susquehanna River Basin within § 43.5 or Appendix C of Part 43. See ANE Commission. Adopting Release, supra note 13, at 6347. 146 Because DDR has elected to rely on the no- Accordingly, an SDR, when utilizing CFTC rather ACTION: Notice. action statement, see supra note 29, the than SEC protocols for dissemination of a security- Commission has not evaluated the DDR Application based swap transaction, would not impose the time SUMMARY: This notice lists the projects against any provisions of Regulation SBSR delay required for a swap transaction that falls approved by rule by the Susquehanna specifically noted as not providing a basis for a within § 43.5. Nevertheless, to offer some River Basin Commission during the Commission enforcement action during the accommodation for certain large-sized security- pendency of the statement. based swaps based on a single credit instrument or period set forth in DATES. 147 ISDA Letter II at 3. The comment refers to a narrow-based index of credit instruments, the DATES: April 1–30, 2021. revisions to Parts 43 and 45 adopted by the CFTC Commission established a size cap of ‘‘$5MM+’’ for ADDRESSES: Susquehanna River Basin in September 2020, which include requirements for any transaction having a true notional size of $5 reporting new data elements as well as changes to million or greater. As explained in the Commission, 4423 North Front Street, how existing data elements should be reported. See Commission’s no-action statement, this cap is also Harrisburg, PA 17110–1788. Part 43 revisions, available at: www.cftc.gov/sites/ applied by the Financial Industry Regulatory FOR FURTHER INFORMATION CONTACT: default/files/2020/11/2020–21568a.pdf; Part 45 Authority when disseminating transaction reports revisions, available at: www.cftc.gov/sites/default/ of economically similar cash debt securities. See id. Jason E. Oyler, General Counsel and files/2020/11/2020–21569a.pdf. at 6347, n.768. 148 See ISDA Letter II at 3. 151 See supra notes 16–18 and accompanying text. 152 See supra note 19 and accompanying text.

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Secretary to the Commission, telephone: Township, Lycoming County, Pa.; Springfield Township, Bradford County, (717) 238–0423, ext. 1312; fax: (717) Consumptive Use of Up to 4.0000 mgd; Pa.; Consumptive Use of Up to 7.5000 238–2436; email: [email protected]. Approval Date: April 12, 2021. mgd; Approval Date: April 26, 2021. Regular mail inquiries May be sent to 11. ARD Operating, LLC; Pad ID: COP 23. Chief Oil & Gas, LLC; Pad ID: the above address. Tr 728 D; ABR–201104001.R2; Taylor Drilling Pad #1; ABR– SUPPLEMENTARY INFORMATION: This Cummings Township, Lycoming 201104024.R2; Lenox Township, notice lists the projects, described County, Pa.; Consumptive Use of Up to Susquehanna County, Pa.; Consumptive below, receiving approval for the 4.0000 mgd; Approval Date: April 12, Use of Up to 2.0000 mgd; Approval consumptive use of water pursuant to 2021. Date: April 26, 2021. the Commission’s approval by rule 12. SWN Production Company, LLC; Pad ID: TI–14 Connolly A Pad; ABR– 24. Chief Oil & Gas, LLC; Pad ID: process set forth in 18 CFR 806.22(f) for Polovitch West Drilling Pad #1; ABR– the time period specified above: 201511006.R2; Liberty Township, Tioga County, Pa.; Consumptive Use of Up to 201104025.R2; Nicholson Township, Water Source Approval—Issued Under 4.9990 mgd; Approval Date: April 13, Wyoming County, Pa.; Consumptive Use 18 CFR 806.22(f) 2021. of Up to 2.0000 mgd; Approval Date: 1. Chief Oil & Gas, LLC; Pad ID: 13. SWN Production Company, LLC; April 26, 2021. Martino Drilling Pad #1; ABR– Pad ID: TI–19 Connolly B—Pad; ABR– 25. Chesapeake Appalachia, L.L.C.; 201604001.R1; Albany Township, 201511007.R2; Liberty Township, Tioga Pad ID: Stempel; ABR–201104020.R2; Bradford County, Pa.; Consumptive Use County, Pa.; Consumptive Use of Up to Asylum Township, Bradford County, of Up to 2.5000 mgd; Approval Date: 4.9990 mgd; Approval Date: April 13, Pa.; Consumptive Use of Up to 7.5000 April 2, 2021. 2021. mgd; Approval Date: April 26, 2021. 2. ARD Operating, LLC; Pad ID: 14. Seneca Resources Company, LLC; 26. XTO Energy, Inc.; Pad ID: Renn Eugene P Nelson Pad A; ABR– Pad ID: Yourgalite 1119; ABR– Unit A; ABR–201103033.R2; Jordan 201103036.R2; Cascade Township, 201012056.R2; Farmington Township, Township, Lycoming County, Pa.; Lycoming County, Pa.; Consumptive Tioga County, Pa.; Consumptive Use of Consumptive Use of Up to 4.0000 mgd; Use of Up to 4.0000 mgd; Approval Up to 4.0000 mgd; Approval Date: April Approval Date: April 26, 2021. Date: April 2, 2021. 13, 2021. 3. Range Resources—Appalachia, 15. Chesapeake Appalachia, L.L.C.; 27. Chesapeake Appalachia, L.L.C.; LLC; Pad ID: Bobst Mountain Hunting Pad ID: Fausto; ABR–201101015.R2; Pad ID: Crain; ABR–201104028.R2; Club #18H–#23H Drilling Pad; ABR– Litchfield Township, Bradford County, Rome Township, Bradford County, Pa.; 201103031.R2; Cogan House Township, Pa.; Consumptive Use of Up to 7.5000 Consumptive Use of Up to 7.5000 mgd; Lycoming County, Pa.; Consumptive mgd; Approval Date: April 15, 2021. Approval Date: April 27, 2021. Use of Up to 2.0000 mgd; Approval 16. BKV Operating, LLC; Pad ID: 28. Chesapeake Appalachia, L.L.C.; Date: April 2, 2021. Baker West (Brothers); ABR–201103049; Pad ID: Hulslander; ABR– 4. Chesapeake Appalachia, L.L.C.; Pad Forest Lake Township, Susquehanna 201104021.R2; Smithfield Township, ID: Franclaire; ABR–201012011.R2; County, Pa.; Consumptive Use of Up to Bradford County, Pa.; Consumptive Use Braintrim Township, Wyoming County, 5.0000 mgd; Approval Date: April 15, of Up to 7.5000 mgd; Approval Date: Pa.; Consumptive Use of Up to 7.5000 2021. April 27, 2021. mgd; Approval Date: April 12, 2021. 17. SWN Production Company, LLC; 29. Chesapeake Appalachia, L.L.C.; 5. Chesapeake Appalachia, L.L.C.; Pad Pad ID: Price Pad; ABR–201104017.R2; Pad ID: Kingsley; ABR–201104029.R2; ID: Sensinger; ABR–201104002.R2; Lenox Township, Susquehanna County, Smithfield Township, Bradford County, Franklin Township, Bradford County, Pa.; Consumptive Use of Up to 4.9990 Pa.; Consumptive Use of Up to 7.5000 Pa.; Consumptive Use of Up to 7.5000 mgd; Approval Date: April 15, 2021. mgd; Approval Date: April 27, 2021. mgd; Approval Date: April 12, 2021. 18. Chief Oil & Gas, LLC; Pad ID: 6. EXCO Resources (PA), LLC; Pad ID: Noble Drilling Pad #1; ABR– 30. Chesapeake Appalachia, L.L.C.; Doebler Drilling Pad #1; ABR– 201104015.R1; Lathrop Township, Pad ID: MPC New; ABR–201104030.R2; 201012033.R2; Penn Township, Susquehanna County, Pa.; Consumptive Cherry Township, Sullivan County, Pa.; Lycoming County, Pa.; Consumptive Use of Up to 2.0000 mgd; Approval Consumptive Use of Up to 7.5000 mgd; Use of Up to 8.0000 mgd; Approval Date: April 19, 2021. Approval Date: April 27, 2021. Date: April 12, 2021. 19. EXCO Resources (PA), LLC; Pad Approvals by Rule—Issued Under 18 7. Diversified Production, LLC; Pad ID: Houseknecht Drilling Pad #1; ABR– CFR 806.22(f)—Revocation ID: Whippoorwill; ABR–201102024.R2; 201012014.R2; Davidson Township, Shippen Township, Cameron County, Sullivan County, Pa.; Consumptive Use 31. Chief Oil & Gas, LLC; Pad ID: Pa.; Consumptive Use of Up to 3.0000 of Up to 8.0000 mgd; Approval Date: Crandall Drilling Pad #1; ABR– mgd; Approval Date: April 12, 2021. April 19, 2021. 201202013.R2; Ridgebury Township, 8. SWN Production Company, LLC; 20. SWN Production Company, LLC; Bradford County, Pa.; Revocation Date: Pad ID: PU–KK Valentine-Soliman Pad; Pad ID: PU–CC Valentine-Price Pad; April 1, 2021. ABR–201103008.R2; Lenox Township, ABR–201104019.R2; Lenox Township, 32. ARD Operating, LLC; Pad ID: COP Susquehanna County, Pa.; Consumptive Susquehanna County, Pa.; Consumptive Tr 356 Pad F; ABR–201007124.R1; Use of Up to 4.9990 mgd; Approval Use of Up to 4.9900 mgd; Approval Cummings Township, Lycoming Date: April 12, 2021. Date: April 19, 2021. County, Pa.; Revocation Date: April 2, 9. SWN Production Company, LLC; 21. Cabot Oil & Gas Corporation; Pad 2021. Pad ID: PU–II Ransom Stas Pad; ABR– ID: LymanJ P1; ABR–201104018.R2; 201103007.R2; Lenox Township, Springville Township, Susquehanna Dated: May 7, 2021. Susquehanna County, Pa.; Consumptive County, Pa.; Consumptive Use of Up to Jason E. Oyler, Use of Up to 4.9990 mgd; Approval 5.0000 mgd; Approval Date: April 19, General Counsel and Secretary to the Date: April 12, 2021. 2021. Commission. 10. ARD Operating, LLC; Pad ID: COP 22. Chesapeake Appalachia, L.L.C.; [FR Doc. 2021–10029 Filed 5–11–21; 8:45 am] Tr 728 C; ABR–201104004.R2; Watson Pad ID: Moody; ABR–201104027.R2; BILLING CODE 7040–01–P

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SUSQUEHANNA RIVER BASIN c07b1a4dce6b then enter meeting 2. Village of Endicott—Public Water COMMISSION number 133 849 0863 and password Supply System, GF Certificate No. GF– U8wvzbbk2p5. You may also 202104163, Village of Endicott, Broome Commission Meeting participant telephonically by dialing County, N.Y.; Ranney Well, South 28 1–877–668–4493 and entering the Well, and South 5 Well; Issue Date: AGENCY: Susquehanna River Basin meeting number 133 849 0863 followed April 14, 2021. Commission. by the # sign. 3. East Petersburg Borough—Public ACTION: Notice. Written comments pertaining to items Water Supply System, GF Certificate No. GF–202104164, East Petersburg SUMMARY: The Susquehanna River Basin on the agenda at the business meeting Borough, Lancaster County, Pa.; Vaughn Commission will conduct its regular may be mailed to the Susquehanna River Basin Commission, 4423 North Rd Well; Issue Date: April 14, 2021. business meeting on June 17, 2021, from 4. Allan Myers Materials PA, Inc.— Harrisburg, Pennsylvania. Details Front Street, Harrisburg, Pennsylvania 17110–1788, or submitted electronically Talmage Quarry, GF Certificate No. GF– concerning the matters to be addressed 202104165, Upper Leacock Township, at the business meeting are contained in through www.srbc.net/about/meetings- events/business-meeting.html. Such Lancaster County, Pa.; consumptive use; the Supplementary Information section Issue Date: April 23, 2021. of this notice. Also the Commission comments are due to the Commission published a document in the Federal on or before June 15, 2021. Comments Dated: May 7, 2021. Register on April 13, 2021, concerning will not be accepted at the business Jason E. Oyler, its public hearing on May 6, 2021, in meeting noticed herein. General Counsel and Secretary to the Harrisburg, Pennsylvania. Authority: Pub. L. 91–575, 84 Stat. 1509 Commission. DATES: The meeting will be held on et seq., 18 CFR parts 806, 807, and 808. [FR Doc. 2021–10031 Filed 5–11–21; 8:45 am] Thursday, June 17, 2021, at 9 a.m. Dated: May 7, 2021. BILLING CODE 7040–01–P ADDRESSES: The meeting will be Jason E. Oyler, conducted digitally from the General Counsel and Secretary to the Susquehanna River Basin Commission, Commission. DEPARTMENT OF TRANSPORTATION 4423 N Front Street, Harrisburg, PA [FR Doc. 2021–10030 Filed 5–11–21; 8:45 am] Federal Aviation Administration 17110. BILLING CODE 7040–01–P FOR FURTHER INFORMATION CONTACT: Notice of Intent To Rule on Request To Jason E. Oyler, General Counsel and Dispose 10.3 Acres of Land at Dillant- SUSQUEHANNA RIVER BASIN Secretary to the Commission, telephone: Hopkins Airport, Swanzey, NH COMMISSION 717–238–0423; fax: 717–238–2436. AGENCY: Federal Aviation SUPPLEMENTARY INFORMATION: The Grandfathering (GF) Registration Administration (FAA), DOT. business meeting will include actions or Notice ACTION: Request for public comments. presentations on the following items: (1) Election of Commission officers for AGENCY: Susquehanna River Basin SUMMARY: Notice is being given that the FY2022; (2) a resolution regarding Commission. FAA is considering a request from the environmental justice; (3) reconciliation ACTION: Notice. City of Keene to dispose of 10.3 acres of of FY2022 budget; (4) ratification of land at Dillant-Hopkins Airport, SUMMARY: This notice lists contracts/grants; (5) proposed Water Swanzey, NH, under the provisions of Grandfathering Registration for projects Resources program for 2022–2024; (6) 49 U.S.C. 47107(h)(2). by the Susquehanna River Basin amendments to the Comprehensive Plan The land is no longer needed for Commission during the period set forth for the Water Resources of the aviation purposes and may be disposed in DATES. Susquehanna River Basin; and (7) of by the airport. Ninety percent of the Regulatory Program projects. DATES: April 1–30, 2021. proceeds will be returned to the Federal This agenda is complete at the time of ADDRESSES: Susquehanna River Basin Aviation Administration and used for a issuance, but other items may be added, Commission, 4423 North Front Street, future airport grant. The remaining ten and some stricken without further Harrisburg, PA 17110–1788. percent will be remitted to the City of notice. The listing of an item on the FOR FURTHER INFORMATION CONTACT: Keene and placed in the airport’s agenda does not necessarily mean that Jason E. Oyler, General Counsel and operation and maintenance fund. An the Commission will take final action on Secretary to the Commission, telephone: avigation easement will be placed over it at this meeting. When the (717) 238–0423, ext. 1312; fax: (717) the property to ensure compatibility Commission does take final action, 238–2436; email: [email protected]. with airport operations and airspace notice of these actions will be published Regular mail inquiries may be sent to protection. in the Federal Register after the the above address. DATES: Comments must be received on meeting. Any actions specific to projects SUPPLEMENTARY INFORMATION: This or before June 11, 2021. will also be provided in writing directly notice lists GF Registration for projects, ADDRESSES: You may send comments to project sponsors. described below, pursuant to 18 CFR using any of the following methods: Due to the COVID–19 orders, the 806, Subpart E for the time period • Federal eRulemaking Portal: Go to meeting will be conducted specified above: http://www.regulations.gov, and follow telephonically and there will be no the instructions on providing Grandfathering Registration Under 18 physical public attendance. The public comments. is invited to attend the Commission’s CFR Part 806, Subpart E • Fax: 202–493–2251. business meeting. You can access the 1. HP Hood LLC—Arkport NY Plant, • Mail: U.S. Department of Business Meeting through a computer GF Certificate No. GF–202104162, Transportation, Docket Operations, (Audio and Video) by following the Village of Arkport, Steuben County, M–30, West Building Ground Floor, link: https://srbc.webex.com/srbc/ N.Y.; Well 1 and consumptive use; Issue Room W 12–140, 1200 New Jersey j.php?MTID=mfff80216a899be862056 Date: April 12, 2021. Avenue SE, Washington, DC 20590.

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• Hand Delivery: Deliver to mail and remediation, reduce employee DEPARTMENT OF TRANSPORTATION address above between 9 a.m. and 5 exposure to potential hazards, and p.m., Monday through Friday, except facilitate maintenance program Federal Railroad Administration Federal holidays. planning. [Docket Number FRA–2021–0050] Interested persons may inspect the A copy of the petition, as well as any request and supporting documents by written communications concerning the Petition for Waiver of Compliance contacting the FAA at the address listed petition, if any, are available for review under FOR FURTHER INFORMATION Under part 211 of title 49 Code of online at www.regulations.gov. CONTACT. Federal Regulations (CFR), this Interested parties are invited to document provides the public notice FOR FURTHER INFORMATION CONTACT: Mr. participate in these proceedings by that on March 6, 2021, the Southern Jorge E. Panteli, Compliance and Land submitting written views, data, or California Railway Museum (SCRM) Use Specialist, Federal Aviation comments. FRA does not anticipate petitioned the Federal Railroad Administration New England Region Administration (FRA) for a waiver of Airports Division, 1200 District Avenue, scheduling a public hearing for these proceedings since the facts do not compliance from certain provisions of Burlington, Massachusetts 01803. the Federal railroad safety regulations Telephone: 781–238–7618. appear to warrant a hearing. If any interested party desires an opportunity contained at 49 CFR 230.17, One Issued in Burlington, Massachusetts, on for oral comment and a public hearing, thousand four hundred seventy-two May 7, 2021. they should notify FRA, in writing, (1472) service day inspection. FRA Julie Seltsam-Wilps, before the end of the comment period assigned the petition Docket Number Deputy Director, ANE–600. and specify the basis for their request. FRA–2021–0050. [FR Doc. 2021–10060 Filed 5–11–21; 8:45 am] For locomotive SCRM VC 2, SCRM All communications concerning these BILLING CODE P requests to extend the period in which proceedings should identify the the 1472 service day inspection must be appropriate docket number and may be completed until November 21, 2021, DEPARTMENT OF TRANSPORTATION submitted by any of the following which is the date at which the methods: locomotive’s next annual inspection is Federal Railroad Administration • Website: http:// due. At the end of the proposed [Docket Number FRA–2021–0044] www.regulations.gov. Follow the online extension period, SCRM VC 2 will have instructions for submitting comments. a total of less than 320 service days, Petition for Waiver of Compliance • Fax: 202–493–2251. which is less than 22% of the 1472 service day allowance. SCRM states that • Under part 211 of title 49 Code of Mail: Docket Operations Facility, the extension would allow it to continue Federal Regulations (CFR), this U.S. Department of Transportation operating the locomotive for fundraising document provides the public notice (DOT), 1200 New Jersey Ave. SE, W12– purposes and aligning the 1472 service that on March 22, 2021, Norfolk 140, Washington, DC 20590. day inspection with the annual Southern Corporation (NS) petitioned Communications received by June 28, inspection would potentially improve the Federal Railroad Administration 2021 will be considered by FRA before SCRM’s financial challenges due to less (FRA) for a waiver of compliance from final action is taken. Comments received revenue in the previous year. certain provisions of the Federal after that date will be considered if A copy of the petition, as well as any railroad safety regulations contained at practicable. written communications concerning the 49 CFR part 213. FRA assigned the petition, is available for review online at Anyone can search the electronic petition Docket Number FRA–2021– www.regulations.gov. 0044. form of any written communications Interested parties are invited to Specifically, NS is requesting relief and comments received into any of our participate in these proceedings by from 49 CFR 213.233(b)(3), and (c), dockets by the name of the individual submitting written views, data, or which require track inspections to be submitting the comment (or signing the comments. FRA does not anticipate conducted visually by railroad track document, if submitted on behalf of an scheduling a public hearing in inspectors at certain frequencies based association, business, labor union, etc.). connection with these proceedings since on class of track. NS is petitioning to Under 5 U.S.C. 553(c), DOT solicits the facts do not appear to warrant a replace 49 CFR 213.233 visual track comments from the public to better hearing. If any interested party desires inspection requirements with a inform its processes. DOT posts these an opportunity for oral comment and a combination of automated and visual comments, without edit, including any public hearing, they should notify FRA, inspections. Proposed automated personal information the commenter in writing, before the end of the inspections would be performed by provides, to www.regulations.gov, as comment period and specify the basis Track Geometry Measurement Systems described in the system of records for their request. three times per month, and visual notice (DOT/ALL–14 FDMS), which can All communications concerning these inspections would be performed at least be reviewed at https:// proceedings should identify the twice per month, for each track segment. www.transportation.gov/privacy. See appropriate docket number and may be In support of its petition, NS also https://www.regulations.gov/ submitted by any of the following references data and analysis from its privacy-notice for the privacy notice of methods: ongoing Track Inspection Test Program, regulations.gov. • Website: http:// Docket Number FRA–2019–0099. Issued in Washington, DC. www.regulations.gov. Follow the online Through the three phases, NS notes that instructions for submitting comments. track geometry defects have a continued John Karl Alexy, • Fax: 202–493–2251. downward trend, indicating overall Associate Administrator for Railroad Safety • Mail: Docket Operations Facility, improvement in track quality. NS states Chief Safety Officer. U.S. Department of Transportation that the relief would positively impact [FR Doc. 2021–10051 Filed 5–11–21; 8:45 am] (DOT), 1200 New Jersey Ave. SE, W12– safety by increasing defect identification BILLING CODE 4910–06–P 140, Washington, DC 20590.

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Communications received by June 28, including extensions and reinstatements must first publish a document in the 2021 will be considered by FRA before of previously approved collections. This Federal Register providing a 60-day final action is taken. Comments received document describes a collection of comment period and otherwise consult after that date will be considered if information for which NHTSA intends with members of the public and affected practicable. to seek OMB approval on Vehicle agencies concerning each proposed Anyone can search the electronic Owner’s Manual Requirements for collection of information. The OMB has form of any written communications Motor Vehicles and Motor Vehicle promulgated regulations describing and comments received into any of our Equipment. what must be included in such a dockets by the name of the individual DATES: Written comments should be document. Under OMB’s regulation (at submitting the comment (or signing the submitted by July 12, 2021. 5 CFR 1320.8(d)), an agency must ask document, if submitted on behalf of an for public comment on the following: (a) ADDRESSES: association, business, labor union, etc.). You may submit comments, Whether the proposed collection of Under 5 U.S.C. 553(c), DOT solicits identified by NHTSA docket number information is necessary for the proper comments from the public to better identified above, through any of the performance of the functions of the inform its processes. DOT posts these following methods: agency, including whether the • Electronic submissions: Go to the comments, without edit, including any information will have practical utility; Federal eRulemaking Portal at http:// personal information the commenter (b) the accuracy of the agency’s estimate www.regulations.gov. Follow the online provides, to www.regulations.gov, as of the burden of the proposed collection instructions for submitting comments. described in the system of records of information, including the validity of • Fax: 202–493–2251. notice (DOT/ALL–14 FDMS), which can • Mail or Hand Delivery: Docket the methodology and assumptions used; be reviewed at https:// Management, U.S. Department of (c) how to enhance the quality, utility, www.transportation.gov/privacy. See Transportation, 1200 New Jersey and clarity of the information to be also https://www.regulations.gov/ Avenue SE, West Building, Room W12– collected; and (d) how to minimize the privacy-notice for the privacy notice of 140, Washington, DC 20590, between 9 burden of the collection of information regulations.gov. a.m. and 5 p.m., Monday through on those who are to respond, including Issued in Washington, DC. Friday, except on Federal holidays. the use of appropriate automated, John Karl Alexy, • Instructions: All submissions must electronic, mechanical, or other Associate Administrator for Railroad Safety include the agency name and docket technological collection techniques or Chief Safety Officer. number for this notice. Note that all other forms of information technology, e.g., permitting electronic submission of [FR Doc. 2021–10052 Filed 5–11–21; 8:45 am] comments received will be posted responses. In compliance with these BILLING CODE 4910–06–P without change to http:// www.regulations.gov, including any requirements, NHTSA asks for public personal information provided. Please comments on the following proposed DEPARTMENT OF TRANSPORTATION see the Privacy Act heading below. collection of information for which the • Privacy Act: Anyone is able to agency is seeking approval from OMB. National Highway Traffic Safety search the electronic form of all Title: Consolidated Vehicle Owner’s Administration comments received into any of our Manual Requirements for Motor dockets by the name of the individual Vehicles and Motor Vehicle Equipment. [Docket No. NHTSA–2021–0032] OMB Control Number: 2127–0541. submitting the comment (or signing the Type of Request: Request for Agency Information Collection comment, if submitted on behalf of an reinstatement with modification of a Activities; Notice and Request for association, business, labor union, etc.). previously approved collection of Comments; Consolidated Vehicles’ You may review DOT’s complete information. Owner’s Manual Requirements for Privacy Act Statement in the Federal Type of Review Requested: Regular. Motor Vehicles and Motor Vehicle Register published on April 11, 2000 Requested Expiration Date of Equipment (65 FR 19477–78) or you may visit Approval: 3 years from date of approval. https://www.transportation.gov/privacy. AGENCY: National Highway Traffic Abstract: The National Traffic and • Docket: For access to the docket to Safety Administration (NHTSA), Motor Vehicle Act, authorizes the read background documents or Department of Transportation (DOT). Secretary of Transportation (NHTSA by comments received, go to http:// delegation), at 49 U.S.C. 30111, to issue ACTION: Notice and request for www.regulations.gov or the street comments on a reinstatement with Federal Motor Vehicle Safety Standards address listed above. Follow the online (FMVSS) that set performance standards modification of a previously approved instructions for accessing the dockets information collection. for motor vehicles and items of motor via internet. vehicle equipment. Further, the SUMMARY: The National Highway Traffic FOR FURTHER INFORMATION CONTACT: For Secretary (NHTSA by delegation) is Safety Administration invites public additional information or access to authorized, at 49 U.S.C. 30117, to comments about our intention to request background documents, contact James require manufacturers to provide approval from the Office of Management Myers, NHTSA, 1200 New Jersey information to first purchasers of motor and Budget (OMB) to reinstate a Avenue SE, West Building, Room W43– vehicles or items of motor vehicle previously-approved information 320, NRM–100, Washington, DC 20590. equipment related to performance and collection with modification. Before a Mr. Myers’ telephone number is 202– safety in printed materials that are Federal agency can collect certain 366–1810. Please identify the relevant attached to or accompany the motor information from the public, it must collection of information by referring to vehicle or item of motor vehicle receive approval from OMB. Under its OMB Control Number. equipment. NHTSA has exercised this procedures established by the SUPPLEMENTARY INFORMATION: Under the authority to require manufacturers to Paperwork Reduction Act of 1995, Paperwork Reduction Act of 1995 (44 provide certain specified safety before seeking OMB approval, Federal U.S.C. 3501 et seq.), before an agency information to be readily available to agencies must solicit public comment submits a proposed collection of consumers and purchasers of motor on proposed collections of information, information to OMB for approval, it vehicles and items of motor vehicle

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equipment. This information is most text words × 1.1 production factor × 0.25 assemble the required information often provided in vehicle owners’ printing factor × $0.00013 per word). (estimated to be 4 hours of review for manuals and the requirements are found Cost burdens for this regulation were new vehicles and 1 hour to review the in 49 CFR parts 563, 571, and 575. This not included in the previous information for non-new vehicles). The information collection request only information collection request. printing cost burden for these owner’s covers requirements or requests to FMVSS No. 108, ‘‘Lamps, reflective manuals would be the number of provide information that is not provided devices, and associated equipment.’’ vehicles produced annually multiplied verbatim in the regulation or standard. This standard requires that certain by the portion of vehicles equipped The information requirements or lamps and reflective devices with with VHAD headlamps, multiplied by requests are included in: Part 563, certain performance levels be installed certain printing factors (an estimated ‘‘Event data recorders;’’ FMVSS No. 108, on motor vehicles to assure that the 500 text words required per owner’s ‘‘Lamps, reflective devices, and roadway is properly illuminated, that manual, a 1.1 multiplier to account for associated equipment;’’ FMVSS No. 110, vehicles can be readily seen, and the aftermarket manuals, a 0.25 printing ‘‘Tire selection and rims;’’ FMVSS No. signals can be transmitted to other factor, and a $0.00013 cost per word). 138, ‘‘Tire Pressure Monitoring drivers sharing the road during day, Because manufacturers no longer equip Systems;’’ FMVSS No. 202a, ‘‘Head night, and inclement weather. Because passenger vehicles, trucks, buses, restraints;’’ FMVSS No. 205, ‘‘Glazing the specific manner in which headlamp trailers, or motorcycles with VHAD materials;’’ FMVSS No. 208, ‘‘Occupant aiming is to be performed is not headlamp systems, NHTSA estimates crash protection;’’ FMVSS No. 210, regulated (only the performance of the the burden hours as 0 hours, and the ‘‘Seat belt assembly anchorages;’’ device is), aiming devices manufactured printing cost at $0. FMVSS No. 213, ‘‘Child restraint or installed by different vehicle and FMVSS No. 110, ‘‘Tire selection and systems;’’ FMVSS No. 226, ‘‘Ejection headlamp manufacturers may work in rims.’’ This standard specifies mitigation;’’ FMVSS No. 303, ‘‘Fuel significantly different ways. To assure requirements for tire selection to System Integrity of Compressed Natural that one particular type of aiming prevent tire overloading. The vehicle’s Gas Vehicles;’’ section 575.103, ‘‘Truck- system, the Vehicle headlamp aiming normal load and maximum load on the camper loading;’’ section 575.104, device (VHAD) can be correctly aimed, tire shall not be greater than applicable ‘‘Uniform tire quality grading this standard requires that instructions specified limits. The standard requires a standards;’’ and section 575.105, for proper use of VHAD systems be part permanently affixed vehicle placard ‘‘Vehicle rollover.’’ of the vehicle as a label, or optionally, specifying vehicle capacity weight, Part 563—Event data recorders. be placed in the vehicle owner’s designated seating capacity, Section 563.11 requires manufacturers manual. manufacturer-recommended cold tire of vehicles equipped with event data It is estimated that manufacturers no inflation pressure, and manufacturer’s recorders (EDRs) to provide a prescribed longer equip passenger vehicles, trucks, recommended tire size. The standard statement (provided verbatim) in the buses, trailers, or motorcycles with further specifies rim construction owner’s manual,1 which is not an VHAD headlamp systems. If vehicles requirements, load limits of non- information collection. Section 563.11 were equipped with VHAD headlamps, pneumatic spare tires, and labeling also states that the owner’s manual may for one model line with new VHAD requirements for non-pneumatic spare include additional information about headlamps, the time to collect the tires, including a required placard. the form, function, and capabilities of required information, prepare technical Owner’s manual information is required the EDR, in supplement to the required input, and review for accuracy of the for non-pneumatic spare tires. statement. This voluntary disclosure of required information placed for Currently, manufacturers do not equip information is an information collection publication in the owner’s manual current passenger vehicles, trucks, for which NHTSA is seeking approval. template is estimated to be 4 hours per buses, trailers, or motorcycles with non- There is a slight burden for respondents manual. In a carry-over vehicle owner’s pneumatic spare tires. If vehicles were to include the voluntary additional manual, we estimate that it would take equipped with non-pneumatic spare information in their owner’s manuals. a vehicle manufacturer 1 hour to review tires, the number of annual burden The vehicle manufacturers which the required information for continued hours imposed on manufacturers who provide this additional information in accuracy relating to VHAD systems. choose to equip their vehicles with this the owner’s manual incur minimal Section 571.108 permits each equipment would be determined from burden. We conservatively estimate that manufacturer a choice in placing the number of model lines produced half of the 406 vehicle models for light headlamp aiming instruction in the annually (of which an estimated 25% duty vehicles will have owner’s owner’s manual or on a label affixed to are new and 75% are on-new, a repeat manuals that contain this supplemental the vehicle. We estimate about half of of previous years’ model lines) information and that the burden for the VHAD aiming applications would be multiplied by the portion of vehicle updating and reviewing this information on labels attached to the VHAD, with models equipped with non-pneumatic will be 1 hour per model line. This the remainder (50%) using information spare tires multiplied by the estimated would result in 203. annual burden in the owner’s manual to convey the number of hours required to assemble hours (203 vehicle model lines × 1 hour necessary information. Therefore, the the required information (estimated to of time × 1 manual per model). number of annual burden hours be 4 hours of review for new vehicles It is estimated that the word content imposed on manufacturers whose and 1 hour to review the information for in the owner’s manual required by Part vehicles are subject to FMVSS No. 108 non-new vehicles). The product of these 563 would be 100 text words. Hence, would be determined from the number factors would provide the number of the cost burden to vehicle of model lines produced annually (of hours required by manufacturers to manufacturers is estimated to be which an estimated 25% are new and produce necessary information to place $30,566.25 (17,100,939 total vehicles × 75% are non-new, a repeat of previous into an owner’s manual ‘‘master’’ for 50% of vehicles including added years’ model lines) multiplied by the printing. The printing cost burden for language in the owner’s manuals × 100 portion of vehicles equipped with these owner’s manuals would be the VHAD headlamps multiplied by the number of vehicles produced annually 1 49 CFR 563.11(a). estimated number of hours required to multiplied by the portion of vehicles

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equipped with non-pneumatic spare owner’s manuals for vehicles information has been included in their tires, multiplied by certain printing manufactured on or after September 1, cleaning and maintenance section of the factors (an estimated 500 text words 2008. The owner’s manual must clearly owner’s manual. The annual estimated required per owner’s manual, a 1.1 identify which seats are equipped with burden from § 571.205 is 176.0 hours multiplier to account for aftermarket head restraints. If the head restraints are (176 model lines × 1 manual per model manuals, a 0.25 printing factor, and a removable, the owner’s manual must × 1 hour). $0.00013 cost per word). Because provide instructions on how to remove The word count required in the manufacturers do not equip current the head restraint by a deliberate action owner’s manual is estimated to be 210 passenger vehicles, trucks, buses, distinct from any act necessary for words. Only buses and low speed trailers, or motorcycles with non- adjustment, and how to reinstall the vehicles currently use plastic type pneumatic spare tires, NHTSA estimates head restraints. The owner’s manual glazing, so NHTSA estimates there are the hour burden as 0 hours, and the must warn that all head restraints must 17,400 new vehicles each year that printing cost at $0. be reinstalled to properly protect include glazing information in the FMVSS No. 138, ‘‘Tire pressure vehicle occupants. Finally, the owner’s owner’s manual. The annual cost monitoring systems.’’ This standard manual must describe, in an easily burden to the respondents to include specifies requirements for a tire pressure understandable format, the adjustment the information required by FMVSS No. monitoring system to warn the driver of of the head restraints and/or seat back 205 is $130.15 (17,400 vehicles × 210 an under-inflated tire condition. Its to achieve appropriate head restraint words of text × 1.1 production factor × purpose is to reduce the likelihood of a position relative to the occupant’s head. 0.25 printing factor × $0.00013 per vehicle crash resulting from tire failure It is estimated that 438 model lines word). due to operation in an under-inflated need to be reviewed annually, but only FMVSS No. 208, ‘‘Occupant crash condition. The standard requires the a fraction (25 percent) need major protection.’’ This standard specifies owner’s manual to include specific revision each year. It is further requirements for both active and passive information on the low-pressure estimated that it would take 5 hours to occupant crash protection systems for warning telltale and the malfunction complete the major revisions. The passenger cars, multipurpose passenger indicator telltale. remaining fraction of model lines (75 vehicles, trucks, and small buses. The information required by FMVSS percent) only require reverification of Certain safety features, such as air bags, No. 138 to be included in the owner’s existing information. The total annual or the care and maintenance of air bag manual is provided verbatim and may burden hours are estimated to be 876 systems, are required to be explained to be taken from the Federal regulation in hours (438 model lines × 0.25 needing the owner by means of the owner’s its entirety. FMVSS No. 138, also states revision × 5 hours plus 438 model lines manual. For example, the owner’s that the owner’s manual may include × 0.75 needing revision × 1 hour). additional information about the low- The word count required to disclose manual must describe the vehicle’s air pressure telltale and the malfunction the required head restraint information bag system and provide precautionary indicator telltale. NHTSA estimates the in the owner’s manual is estimated to be information about the proper burden to be 1 hour for the respondents 1,200 words. The annual cost burden to positioning of the occupants, including to format their owner’s manuals to the respondents to include the children. The owner’s manual must also include the text and additional information required by FMVSS No. warn that no objects should be placed information. There is an average of 438 202a in the owner’s manual is $733,590 over or near the air bag covers. There is model lines each year that include tire (17,100,000 vehicles × 1,200 words of also required information about the pressure monitoring information in the text × 1.1 production factor × 0.25 operation of seat belt assemblies and owner’s manual. Therefore, NHTSA printing factor × $0.00013 per word). other information that could total up to estimates the total annual burden hours FMVSS No. 205, ‘‘Glazing materials.’’ about 20 pages in the owner’s manual. for § 571.138 to be 438 hours (438 model This standard specifies requirement for This material would also need to be lines × 1 manual per model × 1 hour). all glazing material used in windshields, kept current with the latest technical It is estimated that the information windows, and interior partitions of information on an annual basis. required by FMVSS No. 138 in the motor vehicles. Its purpose is to reduce A conservative estimated burden to owner’s manual is equivalent to 400 injuries resulting from impact to glazing produce the required text and words of text. This would result in surfaces, to ensure a necessary degree of information is 16 hours (or 2 days). It is $244,530 in cost burden to the transparency in motor vehicle windows also estimated that a fraction (25 respondents (17,100,000 vehicles × 400 for driver visibility, and to minimize the percent) of the model lines would words of text × 1.1 production factor × possibility of occupants being thrown require updates annually. The 0.25 printing factor × $0.00013 per through the vehicle windows in remaining fraction of model lines (75 word). collisions. More detailed information percent) only require reverification (1- FMVSS No. 202a, ‘‘Head restraints.’’ regarding the care and maintenance of hour burden) of existing information. This standard specifies requirements for plastic glazing items, such as a glass- This would result in 2,750 annual head restraints. The standard, which plastic windshield, is required to be burden hours (579 vehicle model lines seeks to reduce whiplash injuries in rear placed in the vehicle owner’s manual. × 0.25 percent that need updating × 16 collisions, currently requires head It is estimated that the burden to hours of time plus 579 model lines × restraints for front outboard designated provide information in the owner’s 0.75 needing revision × 1 hour). seating positions in passenger cars and manual for detailed care and It is estimated that the word content in light multipurpose passenger maintenance is minimal because in the owner’s manual required by vehicles, trucks and buses with a gross manufacturers already provide this type FMVSS No. 208 would be 5,400 text vehicle weight rating of 4,536 kg or less of information in the vehicle cleaning words. Hence, the cost burden to and specifies requirements for and maintenance section of the owner’s vehicle manufacturers is estimated to be optionally provided rear outboard seat manual. NHTSA estimates a burden for $3,397,680 (17,600,000 total vehicles × head restraints in the same vehicles. each manual of 1 hour because 5,400 text words × 1.1 production factor The standard requires that vehicle manufacturers would need to verify that × 0.25 printing factor × $0.00013 per manufacturers include information in detailed care and maintenance word).

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FMVSS No. 210, ‘‘Seat belt assembly vehicle requirements intended to reduce owner’s manuals under FMVSS No. 303 anchorages.’’ This standard specifies the partial and complete ejection of is developed by manufacturers as part of requirements for seat belt assembly vehicle occupants through side their routine engineering development anchorages to ensure effective occupant windows in crashes, particularly for their vehicles. Therefore, there is a restraint and to reduce the likelihood of rollover crashes. The standard applies to slight burden of 1 hour for respondents failure in a crash. FMVSS No. 210 passenger cars, and to multipurpose to include this information in their requires that manufacturers place the passenger vehicles, trucks, and buses owner’s manuals. This would result in following information in the vehicle with a gross vehicle weight rating of 18 annual burden hours (18 vehicle owner’s manual: (a) An explanation that 4,536 kg (10,000 pounds) or less. model lines × 1 manual per model × 1 child restraints are designed to be Written information must be provided hour of time). secured by means of the vehicle’s seat that describes any ejection mitigation It is estimated that no more than 50 belts, and (b) a statement alerting countermeasure that deploys in the words are required in the owner’s vehicle owners that children are always event of a rollover and a discussion of manual to comply with the safer in the rear seat. the readiness indicator with a list of the requirements in FMVSS No. 303. There It is estimated that it would take a elements of the system being monitored are conservatively 20,000 CNG vehicles vehicle manufacturer no more than 1 by the indicator, a discussion of the produced annually. Hence, the cost hour per vehicle model line to assemble purpose and location of the telltale, and burden to CNG vehicle manufacturers is all of the FMVSS No. 210 information instructions to the consumer on the estimated to be $35.75 (20,000 total for inclusion in the owner’s manual. steps to take if the telltale is units × 50 text words × 1.1 production This would result in 438 annual burden illuminated. factor × 0.25 printing factor × $0.00013 × hours (438 vehicle model lines 1 It is estimated that it would take a per word). Cost burdens for this × manual per model 1 hour). vehicle manufacturer no more than 8 regulation were not included in the It is estimated that the word content hours to compile the required material previous information collection request. in the owner’s manual required by and it is estimated that a fraction (25 FMVSS No. 210 would be 400 text percent) would need major revisions Section 575.103, ‘‘Truck-camper words. Hence, the cost burden to each year. The remaining fraction of loading.’’ This regulation requires vehicle manufacturers is estimated to be model lines (75 percent) only require manufacturers of slide-in campers to $244,530 (17,100,000 total vehicles × reverification (1-hour burden) of affix to each camper a label that 400 text words × 1.1 production factor existing information. This would result contains information relating to × 0.25 printing factor × $0.00013 per in 1,204.5 annual burden hours (438 identification and proper loading of the word). vehicle model lines × 1 manual per camper and to provide more detailed FMVSS No. 213, ‘‘Child restraint model × 0.25 (percent that need loading information in the owner’s systems.’’ This standard specifies updating) × 8 hours of time plus 438 manual. This regulation also requires requirements for child restraint systems model lines × 1 manual per model × manufacturers of trucks that would and requires that manufacturers provide 0.75 (percent needing revision) × 1 accommodate slide-in campers to consumers with detailed information hour). specify the cargo weight ratings and the relating to child safety in air bag- It is estimated that the word content longitudinal limits within which the equipped vehicles. The vehicle owner’s in the owner’s manual required by center of gravity for the cargo weight manual must include information about FMVSS No. 226 would be 3,000 text rating should be located. The the operation and do’s and don’ts of words. Hence, the cost burden to information required for the owner’s built-in child seats. However, as stated vehicle manufacturers is estimated to be manuals under section 575.103 is in FMVSS No. 213, the information $1,833,975 (17,100,000 total vehicles × developed by manufacturers as part of must be made available on strategically 3,000 text words × 1.1 production factor their routine engineering development placed labels within the vehicles, in × 0.25 printing factor × $0.00013 per for their vehicles. The figures to include addition to the vehicle’s owner’s word). in truck and slide-in camper owner’s manual. Thus, it is assumed that the FMVSS No. 303, ‘‘Fuel System manuals are provided in the regulation. burden hours would be minimal since Integrity of Compressed Natural Gas Therefore, there is a slight 1-hour the information is already available Vehicles.’’ This standard specifies burden for respondents to include this from the information required to requirements for the integrity of motor information in their owner’s manuals. vehicle fuel systems using compressed This would result in 35 annual burden produce the labels. This would result in × natural gas (CNG), including the CNG hours (35 vehicle model lines 1 579 annual burden hours (579 vehicle × model lines × 1 manual per model × 1 fuel systems of bi-fuel, dedicated, and manual per model 1 hour of time). hour). dual fuel CNG vehicles. This regulation It is estimated that 480 words are It is estimated that the recurring requires manufacturers to permanently minimally required in the owner’s information required for child safety in label CNG vehicles, near the vehicle manual to comply with § 575.103. There the owner’s manual would be 500 text refueling connection, with service are approximately 2,300,000 pickup words. Hence, the cost burden to pressure information and the statement trucks and 11,000 truck camper units vehicle manufacturers is estimated to be ‘‘See instructions on fuel container for produced annually. These total to an $314,600 (17,600,000 total vehicles × inspection and service life.’’ annual production of 2,311,000 units. 500 text words × 1.1 production factor Manufacturers of CNG vehicles shall Hence, the cost burden to vehicle × 0.25 printing factor × $0.00013 per also provide a first purchaser this manufacturers is estimated to be word). information in either an owner’s manual $39,656.76 (2,311,000 total units × 480 FMVSS No. 226, ‘‘Ejection or a one-page document. The service text words × 1.1 production factor × 0.25 mitigation.’’ This standard establishes pressure information required for the printing factor × $0.00013 per word).

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Section 575.104, ‘‘Uniform tire quality which manufacturers shall include in Affected Public: Vehicle grading standards.’’ This regulation the owner’s manual, is provided in the manufacturers. requires manufacturers of motor regulation in its entirety or equivalent Estimated Number of Respondents: vehicles to inform the drivers of the form. Hence there is a slight 1-hour 52. type and quality of the tires with which burden on the respondents for inclusion Frequency: On occasion. their vehicles are equipped. A of this information into their owner’s Number of Responses: 52. statement, which manufacturers shall manuals. This would result in 18 annual × Estimated Total Annual Burden include in the owner’s manual, is burden hours (18 vehicle model lines Hours: 7,315. provided in the regulation in its entirety 1 manual per model × 1 hour of time). Estimated Total Annual Burden or equivalent form. Hence there is a It is estimated that 117 words are Hours Cost: $368,969. slight 1-hour burden on the respondents minimally required in the owner’s for inclusion of this information into The labor costs associated with these manual to comply with § 575.105. There burden hours are derived by using their owner’s manuals. This would are approximately 2,700,000 utility result in 579 annual burden hours (579 hourly labor rates published by the vehicles with 4-wheel drive and a vehicle model lines × 1 manual per Bureau of Labor Statistics (BLS). For the wheelbase of 110 inches or less. model × 1 hour of time). burden hours associated with compiling Therefore, the cost burden to vehicle It is estimated that 390 words are the owner’s manual information manufacturers is estimated to be minimally required in the owner’s required under the FMVSSs, NHTSA $11,293.43 (2,700,000 total vehicles × manual to comply with § 575.104. There uses the mean hourly wage of $35.41 117 text words × 1.1 production factor are approximately 13,857,300 vehicles per hour for ‘‘Technical Writers’’ × 0.25 printing factor × $0.00013 per 3 covered by this regulation. Hence, the (occupational code 27–3042). BLS word). Cost burdens for this regulation cost burden to vehicle manufacturers is estimates that hourly wages represent were not included in the previous estimated to be $193,205.41 (13,857,300 approximately 70.2% of total information collection request. total vehicles × 390 text words × 1.1 compensation for private industry production factor × 0.25 printing factor Description of the Need for the workers.4 Therefore, NHTSA estimates × $0.00013 per word). Cost burdens for Information and Proposed Use of the the labor cost associated with less senior this regulation were not included in the Information: The Federal program for Technical Writers to be $50.44 per hour. previous information collection request. reducing highway fatalities, injuries and The total labor cost associated with the Section 575.105, ‘‘Vehicle rollover.’’ crashes is likely to be adversely affected burden hours of this information This regulation requires manufacturers if the information is not collected, since collection are determined by of utility vehicles 2 to alert the drivers of consumers would not be made readily multiplying the annual burden hours by those vehicles that they have a higher aware of certain important safety $50.44; therefore, the total annual labor possibility of rollover than other vehicle provisions that apply to critical costs are estimated to be $368.968.60 in types and to advise them of steps that components of their vehicles and would each of the next three years. can be taken to reduce the possibility of not have a readily accessible source of The table below summarizes the total rollover and/or to reduce the likelihood information when circumstances require hour burden and associated labor costs of injury in a rollover. A statement, such information. estimates. ESTIMATED HOUR BURDEN AND ASSOCIATED LABOR COSTS SUMMARY TABLE

Estimated total Estimated annual labor Part/section Brief title total annual costs at burden hours $50.44/hour

563 ...... Event Data Recorders ...... 203 $10,239.32 571.108 ...... Lighting ...... 0 0.00 571.110 ...... Tire Selection and Rims ...... 0 0.00 571.138 ...... Tire Pressure Monitoring ...... 438 22,092.72 571.202a ...... Head Restraints ...... 876 44,185.44 571.205 ...... Glazing ...... 176 8,877.44 571.208 ...... Crash Protection ...... 2,750 138,710.00 571.210 ...... Seat Belt Anchors ...... 438 22,092.72 571.213 ...... Child Restraints ...... 579 29,204.76 571.226 ...... Ejection Mitigation ...... 1,205 60,780.20 571.303 ...... CNG Fuel Systems ...... 18 907.92 575.103 ...... Truck-Camper Loading ...... 35 1,765.40 575.104 ...... Tire Quality ...... 579 29,204.76 575.105 ...... Utility Vehicles ...... 18 907.92

Totals ...... 7,315 368,968.60 or 368,969

Estimated Annual Printing Burden The total annual cost to the in vehicles’ owner’s manuals is Cost: $7,043,793. respondents for information published summarized in the table below.

2 49 CFR 575.105 states Utility vehicles means 3 May 2019 National Industry-Specific 4 https://www.bls.gov/news.release/pdf/ecec.pdf. multipurpose passenger vehicles (other than those Occupational Employment and Wage Estimates, Accessed March 20, 2020. Table 1. Employer Costs which are passenger car derivatives) which have a NAICS 336100—Motor Vehicle Manufacturing, for Employee Compensation by ownership [March wheelbase of 110 inches or less and special features https://www.bls.gov/oes/current/naics4_ 2020], https://www.bls.gov/news.release/ for occasional off-road operation. 336100.htm#27-0000. ecec.t01.htm.

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Estimated total Part/section Brief title costs to respondents

563 ...... Event Data Recorders ...... $30,566.25 571.108 ...... Lighting ...... 0.00 571.110 ...... Tire Selection and Rims ...... 0.00 571.138 ...... Tire Pressure Monitoring Systems ...... 244,530.00 571.202a ...... Head Restraints ...... 733,590.00 571.205 ...... Glazing ...... 130.15 571.208 ...... Occupant Crash Protection ...... 3,397,680.00 571.210 ...... Seat Belt Assembly Anchors ...... 244,530.00 571.213 ...... Child Restraints Systems ...... 314,600.00 571.226 ...... Ejection Mitigation ...... 1,833,975.00 571.303 ...... Fuel System Integrity of Compressed Natural Gas Vehicles 35.75 575.103 ...... Truck-Camper Loading ...... 39,656.76 575.104 ...... Uniform Tire Quality Grading Standards ...... 193,205.41 575.105 ...... Vehicle Rollover ...... 11,293.43

Total Costs ...... 7,043,792.75 or 7,043,793

Public Comments Invited: You are SUMMARY: This document grants in full to be as effective in reducing and asked to comment on any aspects of this the Toyota Motor North America, Inc.’s deterring motor vehicle theft as information collection, including (a) (Toyota) petition for exemption from the compliance with the parts-marking whether the proposed collection of Federal Motor Vehicle Theft Prevention requirements. In accordance with this information is necessary for the proper Standard (theft prevention standard) for statute, NHTSA promulgated 49 CFR performance of the functions of the its Corolla Cross vehicle line beginning part 543, which establishes the process Department, including whether the in model year (MY) 2022. The petition through which manufacturers may seek information will have practical utility; is granted because the agency has an exemption from the theft prevention (b) the accuracy of the Department’s determined that the antitheft device to standard. estimate of the burden of the proposed be placed on the line as standard 49 CFR 543.5 provides general information collection; (c) ways to equipment is likely to be as effective in submission requirements for petitions enhance the quality, utility and clarity reducing and deterring motor vehicle and states that each manufacturer may of the information to be collected; and theft as compliance with the parts- petition NHTSA for an exemption of (d) ways to minimize the burden of the marking requirements of the theft collection of information on prevention standard. one vehicle line per model year. Among other requirements, manufacturers must respondents, including the use of DATES: The exemption granted by this automated collection techniques or notice is effective beginning with the identify whether the exemption is other forms of information technology. 2022 model year. sought under section 543.6 or section 543.7. Under section 543.6, a The agency will summarize and/or FOR FURTHER INFORMATION CONTACT: include your comments in the request Carlita Ballard, Office of International manufacturer may request an exemption for OMB’s clearance of this information Policy, Fuel Economy, and Consumer by providing specific information about collection. Programs, NHTSA, West Building, the antitheft device, its capabilities, and the reasons the petitioner believes the Authority: The Paperwork Reduction Act W43–439, NRM–310, 1200 New Jersey Avenue SE, Washington, DC 20590. Ms. device to be as effective at reducing and of 1995; 44 U.S.C. Chapter 35, as amended; deterring theft as compliance with the 49 CFR 1.49; and DOT Order 1351.29. Ballard’s phone number is (202) 366– 5222. Her fax number is (202) 493–2990. parts-marking requirements. Section Raymond R. Posten, SUPPLEMENTARY INFORMATION: Under 49 543.7 permits a manufacturer to request Associate Administrator for Rulemaking. U.S.C. Chapter 331, the Secretary of an exemption under a more streamlined [FR Doc. 2021–09984 Filed 5–11–21; 8:45 am] Transportation (and the National process if the vehicle line is equipped with an antitheft device (an BILLING CODE 4910–59–P Highway Traffic Safety Administration (NHTSA) by delegation) is required to ‘‘immobilizer’’) as standard equipment promulgate a theft prevention standard that complies with one of the standards 1 DEPARTMENT OF TRANSPORTATION to provide for the identification of specified in that section. certain motor vehicles and their major National Highway Traffic Safety replacement parts to impede motor 1 49 CFR 543.7 specifies that the manufacturer must include a statement that their entire vehicle Administration vehicle theft. NHTSA promulgated line is equipped with an immobilizer that meets regulations at 49 CFR part 541 (theft one of the following standards: Petition for Exemption From the prevention standard) to require parts- (1) The performance criteria (subsections 8 Federal Motor Vehicle Theft Prevention marking for specified passenger motor through 21) of C.R.C, c. 1038.114, Theft Protection Standard; Toyota Motor North and Rollaway Prevention (in effect March 30, 2011), vehicles and light trucks. Pursuant to 49 as excerpted in appendix A of [part 543]; America, Inc. U.S.C. 33106, manufacturers that are (2) National Standard of Canada CAN/ULC– subject to the parts-marking S338–98, Automobile Theft Deterrent Equipment AGENCY: National Highway Traffic requirements may petition NHTSA, by and Systems: Electronic Immobilization (May 1998); Safety Administration (NHTSA), delegation, for an exemption for a line (3) United Nations Economic Commission for Department of Transportation (DOT). Europe (UN/ECE) Regulation No. 97 (ECE R97), of passenger motor vehicles equipped Uniform Provisions Concerning Approval of Vehicle ACTION: Grant of petition for exemption. with an antitheft device as standard Alarm System (VAS) and Motor Vehicles with equipment that NHTSA decides is likely Continued

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Section 543.8 establishes Prevention, Toyota petitioned for an equipped with the antitheft device is requirements for processing petitions for exemption for its specified vehicle line likely to have a theft rate equal to or less exemption from the theft prevention from the parts-marking requirements of than that of passenger motor vehicles of standard. As stated in section 543.8(a), the theft prevention standard, beginning the same, or a similar, line which have NHTSA processes any complete in MY 2022. Toyota petitioned under 49 parts marked in compliance with part exemption petition. If NHTSA receives CFR 543.6, Petition: Specific content 541.5 an incomplete petition, NHTSA will requirements, which, as described The following sections describe notify the petitioner of the deficiencies. above, requires manufacturers to Toyota’s petition information provided Once NHTSA receives a complete provide specific information about the pursuant to 49 CFR part 543, Exemption petition the agency will process it and, antitheft device installed as standard from Vehicle Theft Prevention. To the in accordance with section 543.8(b), equipment on all vehicles in the line for extent that specific information in will grant the petition if it determines which an exemption is sought, the Toyota’s petition is subject to a properly that, based upon substantial evidence, antitheft device’s capabilities, and the filed confidentiality request, that the standard equipment antitheft device reasons the petitioner believes the information was not disclosed as part of is likely to be as effective in reducing device to be as effective at reducing and this notice.6 and deterring motor vehicle theft as deterring theft as compliance with the II. Toyota’s Petition for Exemption compliance with the parts-marking parts-marking requirements. requirements of part 541. More specifically, section 543.6(a)(1) In a petition dated November 19, Section 543.8(c) requires NHTSA to requires petitions to include a statement 2020, as supplemented with additional issue its decision either to grant or to that an antitheft device will be installed information submitted on April 6, deny an exemption petition not later as standard equipment on all vehicles in 2021,7 Toyota requested an exemption than 120 days after the date on which the line for which the exemption is from the parts-marking requirements of a complete petition is filed. If NHTSA sought. Under section 543.6(a)(2), each the theft prevention standard for the does not make a decision within the petition must list each component in the Corolla Cross vehicle line beginning 120-day period, the petition shall be antitheft system, and include a diagram with MY 2022. deemed to be approved and the showing the location of each of those In its petition, Toyota provided a manufacturer shall be exempt from the components within the vehicle. As detailed description and diagram of the standard for the line covered by the required by section 543.6(a)(3), each identity, design, and location of the petition for the subsequent model year.2 petition must include an explanation of components of the antitheft device for Exemptions granted under part 543 the means and process by which the the Corolla Cross vehicle line. Toyota apply only to the vehicle line or lines device is activated and functions, stated that its MY 2022 Corolla Cross that are subject to the grant and that are including any aspect of the device vehicle line will be installed with an equipped with the antitheft device on designed to: (1) Facilitate or encourage engine immobilizer device as standard which the line’s exemption was based, its activation by motorists; (2) attract equipment, as required by 543.6(a)(1). and are effective for the model year attention to the efforts of an Toyota also stated that it will offer two beginning after the model year in which unauthorized person to enter or move a entry/start systems on its Corolla Cross NHTSA issues the notice of exemption, vehicle by means other than a key; (3) vehicle line. Specifically, Toyota stated unless the notice of exemption specifies prevent defeating or circumventing the that it will offer a ‘‘smart entry and a later year. device by an unauthorized person start’’ system or a ‘‘transponder key and Sections 543.8(f) and (g) apply to the attempting to enter a vehicle by means start’’ system on its vehicle line. manner in which NHTSA’s decisions on other than a key; (4) prevent the Specifically, key components of the petitions are to be made known. Under operation of a vehicle which an ‘‘smart entry and start’’ system will section 543.8(f), if the petition is sought unauthorized person has entered using include a certification engine control under section 543.6, NHTSA publishes means other than a key; and (5) ensure unit (ECU), engine switch, steering lock a notice of its decision to grant or deny the reliability and durability of the ECU, security indicator, door control the exemption petition in the Federal device.3 receiver, electrical key, ID code box, and Register and notifies the petitioner in In addition to providing information an engine control module (ECM). Key writing. Under section 543.8(g), if the about the antitheft device and its components of the ‘‘transponder key petition is sought under section 543.7, functionality, petitioners must also and start’’ system will include a NHTSA notifies the petitioner in writing submit the reasons for their belief that transponder key ECU assembly, of the agency’s decision to grant or deny the antitheft device will be effective in transponder key coil, security indicator, the exemption petition. reducing and deterring motor vehicle ignition key and an ECM. Toyota stated This grant of petition for exemption theft, including any theft data and other that there will also be position switches considers Toyota Motor North America, data that are available to the petitioner installed on the vehicle to protect the Inc.’s (Toyota) petition for its Corolla and form a basis for that belief,4 and the hood and doors from unauthorized Cross vehicle line beginning in MY reasons for their belief that the agency tampering/opening. Toyota further 2022. should determine that the antitheft explained that locking the doors can be device is likely to be as effective as accomplished through use of a key, I. Specific Petition Content compliance with the parts-marking wireless switch or its smart entry Requirements Under 49 CFR 543.6 requirements of part 541 in reducing system, and that unauthorized Pursuant to 49 CFR part 543, and deterring motor vehicle theft. In tampering with the hood or door Exemption from Vehicle Theft support of this belief, the petitioners without using one of these methods will should include any statistical data that cause the position switches to trigger its Regard to Their Alarm System (AS) in effect August are available to the petitioner and form 8, 2007; or the basis for the petitioner’s belief that 5 49 CFR 543.6(a)(5). 6 (4) UN/ECE Regulation No. 116 (ECE R116), a line of passenger motor vehicles 49 CFR 512.20(a). Uniform Technical Prescriptions Concerning the 7 As discussed above, per 49 CFR 543.8(a), Protection of Motor Vehicles Against Unauthorized NHTSA processes the petition once the Use in effect on February 10, 2009. 3 49 CFR 543.6(a)(3). manufacturer submits all the information required 2 49 U.S.C. 33106(d). 4 49 CFR 543.6(a)(4). by 49 CFR part 543.

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antitheft device to operate. Toyota will available. However, Toyota compared efforts of unauthorized persons to enter not incorporate an audible and visual its proposed device to other devices or operate a vehicle by means other than alarm system on its vehicle line. NHTSA has determined to be as a key; preventing defeat or Pursuant to Section 543.6(a)(3), effective in reducing and deterring circumvention of the device by Toyota explained that its ‘‘smart entry motor vehicle theft as would unauthorized persons; preventing and start’’ system is activated when the compliance with the parts-marking operation of the vehicle by engine switch is pushed from the ‘‘ON’’ requirements. Toyota compared its unauthorized entrants; and ensuring the ignition status to any other status. The proposed device to that which has been reliability and durability of the device. certification ECU then performs the installed on the Toyota RAV4 and RAV4 The agency notes that 49 CFR part calculation for the immobilizer and the HV vehicle line, which was granted a 541, Appendix A–1, identifies those immobilizer signals the ECM to activate parts-marking exemption from 49 CFR lines that are exempted from the theft the device. Toyota stated that key part 541 by the agency beginning with prevention standard for a given model verification is also performed after the MY 2014 vehicles. Toyota also year. 49 CFR 543.8(f) contains driver pushes the engine switch. referenced the NHTSA theft rate data publication requirements incident to the Specifically, after the driver pushes the published for the RAV4 and RAV4 HV disposition of all part 543 petitions. engine switch, the certification ECU and showing an overall passenger motor Advanced listing, including the release steering lock ECU receive confirmation vehicle’s average of stolen rates in of future product nameplates, the of a valid key, and the certification ECU calendar year 2014 of 1.15 per thousand beginning model year for which the allows the ECM to start the engine. vehicles produced which the RAV4 petition is granted and a general Toyota stated that the ‘‘transponder key vehicles had a theft rate of 0.36. (see 82 description of the antitheft device is and start’’ system is activated when the FR 28246). Therefore, Toyota concluded necessary in order to notify law ignition key is turned from the ‘‘ON’’ that the antitheft device proposed for its enforcement agencies of new vehicle position to some other status and the Corolla Cross vehicle line is no less lines exempted from the parts-marking key is removed, allowing the effective than those devices on the lines requirements of the theft prevention immobilizer to activate and signal the for which NHTSA has already granted standard. ECM. Toyota also stated that in both full exemption from the parts-marking If Toyota decides not to use the systems, a security indicator is installed requirements. Toyota stated that it exemption for its requested vehicle line, notifying the users and others inside believes that installing the immobilizer the manufacturer must formally notify and outside the vehicle with the status device as standard equipment reduces the agency. If such a decision is made, of the immobilizer. Toyota further the theft rate for the Corolla Cross explained that the security indicator vehicle line and expects it to experience the line must be fully marked as flashes continuously when the comparable effectiveness and ultimately required by 49 CFR 541.5 and 541.6 immobilizer is activated, and turns off be more effective than parts-marking (marking of major component parts and when it is deactivated. labels. replacement parts). As required in section 543.6(a)(3)(v), NHTSA notes that if a manufacturer Toyota provided information on the III. Decision To Grant the Petition to which an exemption has been granted reliability and durability of its proposed Pursuant to 49 U.S.C. 33106 and 49 wishes in the future to modify the device. To ensure reliability and CFR 543.8(b), the agency grants a device on which the exemption is durability of the device, Toyota petition for exemption from the parts- based, the company may have to submit conducted tests based on its own marking requirements of part 541, either a petition to modify the exemption. specified standards. Toyota provided a in whole or in part, if it determines that, Section 543.8(d) states that a part 543 detailed list of the tests conducted (i.e., based upon substantial evidence, the exemption applies only to vehicles that high and low temperature operation, standard equipment antitheft device is belong to a line exempted under this strength, impact, vibration, electro- likely to be as effective in reducing and part and equipped with the antitheft magnetic interference, etc.). Toyota deterring motor vehicle theft as device on which the line’s exemption is stated that it believes that its device is compliance with the parts-marking based. Further, section 543.10(c)(2) reliable and durable because it complied requirements of part 541. The agency provides for the submission of petitions with its own specific design standards finds that Toyota has provided adequate ‘‘to modify an exemption to permit the and the antitheft device is installed on reasons for its belief that the antitheft use of an antitheft device similar to but other vehicle lines for which the agency device for its vehicle line is likely to be differing from the one specified in the has granted a parts-marking exemption. as effective in reducing and deterring exemption.’’ 8 As an additional measure of reliability motor vehicle theft as compliance with For the foregoing reasons, the agency and durability, Toyota stated that its the parts-marking requirements of the hereby grants in full Toyota’s petition vehicle key cylinders are covered with theft prevention standard. This for exemption for the Corolla Cross casting cases to prevent the key cylinder conclusion is based on the information vehicle line from the parts-marking from easily being broken. Toyota further Toyota provided about its antitheft requirements of 49 CFR part 541, explained that there are approximately device. NHTSA believes, based on beginning with its MY 2022 vehicles. 10,000 combinations for inner cut keys Toyota’s supporting evidence, the which makes it difficult to unlock the antitheft device described for its vehicle 8 The agency wishes to minimize the doors without using a valid key because line is likely to be as effective in administrative burden that section 543.10(c)(2) the key cylinders would spin out and reducing and deterring motor vehicle could place on exempted vehicle manufacturers cause the locks to not operate. theft as compliance with the parts- and itself. The agency did not intend in drafting part 543 to require the submission of a modification Toyota stated that the 2022 model marking requirements of the theft petition for every change to the components or year is the first year that the first Corolla prevention standard. design of an antitheft device. The significance of Cross model with immobilizers installed The agency concludes that Toyota’s many such changes could be de minimis. Therefore, as standard equipment is available, and antitheft device will provide the five NHTSA suggests that if a manufacturer with an exemption contemplates making any changes, the accordingly at the time of the petition types of performance features listed in effects of which might be characterized as de submission, theft rate data for the MY section 543.6(a)(3): Promoting minimis, it should consult the agency before 2022 Corolla Cross vehicle line is not activation; attracting attention to the preparing and submitting a petition to modify.

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Issued under authority delegated in 49 CFR Washington, DC, 20590–0001 between 9 of the burden of the proposed collection 1.95 and 501.8. a.m. and 5 p.m. ET, Monday through of information, including the validity of Raymond R. Posten, Friday, except Federal holidays. To be the methodology and assumptions used; Associate Administrator for Rulemaking. sure someone is there to help you, (c) how to enhance the quality, utility, [FR Doc. 2021–09982 Filed 5–11–21; 8:45 am] please call (202) 366–9322 before and clarity of the information to be BILLING CODE 4910–59–P coming. collected; (d) how to minimize the • Fax: 202–493–2251. burden of the collection of information All submissions must include the on those who are to respond, including DEPARTMENT OF TRANSPORTATION agency name and docket number for this the use of appropriate automated, notice. Note that all comments received electronic, mechanical, or other National Highway Traffic Safety will be posted without change to http:// technological collection techniques or Administration www.regulations.gov, including any other forms of information technology, [Docket No. NHTSA–2021–0031] personal information provided. Please e.g. permitting electronic submission of see the Privacy Act heading below. responses. In compliance with these Agency Information Collection Privacy Act: Anyone is able to search requirements, NHTSA asks for public Activities; Notice and Request for the electronic form of all comments comments on the following proposed Comment; Motorcycle Helmets received into any of our dockets by the collection of information for which the (Labeling) name of the individual submitting the agency is seeking approval from OMB. comment (or signing the comment, if Title: Motorcycle Helmets (Labeling). AGENCY: National Highway Traffic submitted on behalf of an association, OMB Control Number: 2127–0518. Safety Administration (NHTSA), business, labor union, etc.). You may Type of Request: Reinstatement of a Department of Transportation. review DOT’s complete Privacy Act previously approved collection of ACTION: Notice and request for Statement in the Federal Register information. comments on a reinstatement of a published on April 11, 2000 (65 FR Type of Review Requested: Regular. Requested Expiration Date of previously approved collection of 19477–78) or you may visit https:// Approval: Three years from the information. www.transportation.gov/privacy. approval date. SUMMARY: The National Highway Traffic Docket: For access to the docket, go to Summary of the Collection of Safety Administration (NHTSA) invites http://www.regulations.gov or the street Information: The National Traffic and public comments about our intention to address listed above. Follow the online Motor Vehicle Safety Act authorizes the request approval from the Office of instructions for accessing the dockets Secretary of Transportation (NHTSA by Management and Budget (OMB) for a online. To be sure someone is there to delegation), at 49 U.S.C. 30111, to issue reinstatement of a previously approved help you at the street address, please Federal Motor Vehicle Safety Standards collection of information entitled call (202) 366–9322 before coming. (FMVSS) that set performance standards ‘‘Motorcycle Helmets (Labeling)’’ (OMB FOR FURTHER INFORMATION CONTACT: For for motor vehicles and items of motor Control Number: 2127–0518). Before a additional information or access to vehicle equipment. Vehicle and Federal agency can collect certain background documents, contact Mr. equipment manufacturers must certify information from the public, it must Christian Nguyen, U.S. Department of that their vehicles or equipment comply receive approval from OMB. Under Transportation, NHTSA, 1200 New with these standards. Further, the procedures established by the Jersey Avenue SE, West Building Room Secretary (NHTSA by delegation) is Paperwork Reduction Act of 1995, W43–418, NRM–130, Washington, DC authorized, at 49 U.S.C. 30117, to before seeking OMB approval, Federal 20590. Mr. Christian Nguyen’s require manufacturers to provide agencies must solicit public comment telephone number is 202–366–2365 and information to first purchasers of motor on proposed collections of information, fax number is 202–366–7002. Please vehicles or motor vehicle equipment including extensions and reinstatement identify the relevant collection of when the vehicle or equipment is of previously approved collections. This information by referring to its OMB purchased, in the form of printed matter document describes NHTSA’s Control Number. placed in the vehicle or attached to the information collection on motorcycle SUPPLEMENTARY INFORMATION: Under the vehicle or motor vehicle equipment. helmet labeling. Paperwork Reduction Act of 1995 (44 Using this authority, NHTSA issued DATES: You should submit your U.S.C. 3501 et seq.), before an agency the initial FMVSS No. 218, ‘‘Motorcycle comments early enough to ensure that submits a proposed collection of helmets,’’ in 1974. Motorcycle helmets Docket Management receives them no information to OMB for approval, it are devices used to protect motorcyclists later than July 12, 2021. must first publish a document in the from head injury in motor vehicle ADDRESSES: You may submit comments Federal Register providing a 60-day accidents. The standard requires the (identified by the DOT Docket ID comment period and otherwise consult manufacturer to label every helmet it Number above) by any of the following with members of the public and affected produces to indicate compliance with methods: agencies concerning each proposed the requirements of the Standard. The • Federal eRulemaking Portal: Go to collection of information. The OMB has certification label consists of the symbol http://www.regulations.gov. Follow the promulgated regulations describing ‘‘DOT,’’ the term ‘‘FMVSS No. 218,’’ the online instructions for submitting what must be included in such a word ‘‘CERTIFIED,’’ the precise model comments. document. Under OMB’s regulation (at designation, and the manufacturer’s • Mail: Docket Management Facility: 5 CFR 1320.8(d)), an agency must ask name and/or brand on the outer shell of U.S. Department of Transportation, 1200 for public comment on the following: (a) the helmet towards the posterior bottom New Jersey Avenue SE, West Building Whether the proposed collection of edge. Manufacturers are also required to Ground Floor, Room W12–140, information is necessary for the proper label every helmet to provide helmet Washington, DC 20590–0001. performance of the functions of the owners with important safety • Hand Delivery or Courier: West agency, including whether the information including manufacturer’s Building Ground Floor, Room W12–140, information will have practical utility; name, discrete size, month and year of 1200 New Jersey Avenue SE, (b) the accuracy of the agency’s estimate manufacture, and specific instructions

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to the purchaser. FMVSS No. 218, S5.6 and consumers use the information to For the labor costs associated with the requires that each helmet shall be make decisions when purchasing burden hours for affixing labels to labeled permanently and legibly in a motorcycle helmets. helmets, NHTSA uses the average wage manner such that the label(s) can be Affected Public: Motorcycle helmet of $22.59 per hour for ‘‘Assemblers and read easily without removing padding manufacturers. Fabricators’’ (occupational code 51– or any other permanent part. Estimated Number of Respondents: 2000) published by the Bureau of Labor Description of the Need for the 45. Statistics (BLS).1 BLS estimates that Information and Proposed Use of the Frequency: On occasion. wages represent approximately 70.2% of Information: The labeling requirement Estimated Total Annual Burden total compensation for private industry in the Standard supports the Hours: 9,100 hours. workers.2 Therefore, NHTSA calculates Department of Transportation’s strategic NHTSA estimates that 3,250,000 the labor cost associated with goal in safety, by ensuring that motorcycle helmets are manufactured Assemblers and Fabricators to be $32.18 motorcycle helmets are manufactured annually by 45 motorcycle helmet per hour ($22.59 ÷ 0.702). Multiplying and certified to the performance manufacturers. NHTSA also estimates that hourly rate by the estimated 9,100 requirements of the Standard. NHTSA that 10 seconds are spent labeling each labor hours needed to affix labels yields uses this information for enforcement helmet. Therefore, the estimated total an estimated total annual labor cost of purposes to ensure that manufacturers annual burden hours for the collection $292,838 ($32.18 × 9,100 hours). The certify compliance with the Standard. of information required in FMVSS No. total estimated burden hours and State and local law enforcement use this 218 is 9,100 hours (3,250,000 × 10 associated labor costs are detailed in the information to enforce helmet-use laws, seconds, rounded). table below:

Number of Time to Estimated Number of helmets Total respondents produced affix total annual Total Labor cost burden Total (helmet annually label per burden hours labor cost (per respondent) hours labor manufacturers) (per respondent) helmet (per respondent) per hour (rounded) cost (rounded) (seconds) (rounded)

45 72,000 10 200 $32.18 $6,500 9,100 $292,838

Estimated Total Annual Burden Cost: printing and material cost per helmet is responses (helmets produced) per year $1,137,500. $0.35. The total annual cost to ($0.35 × 3,250,000). The total estimated The total annual cost to the respondents is calculated by annual burden costs are detailed in the respondents is estimated to be multiplying the printing and material table below: $1,137,500. NHTSA estimates that the cost ($0.35) by the estimated 3,250,000

Number of Number of helmets Annual printing Estimated total respondents produced Printing and and material cost Total number annual printing (helmet annually per material cost per manufacturer of helmets and material manufacturers) respondent per helmet (rounded) produced annually costs (rounded)

45 72,000 $0.35 $25,200.00 3,250,000 $1,137,500.00

Public Comments Invited: You are Authority: The Paperwork Reduction Act ACTION: Grant of petition for exemption. asked to comment on any aspects of this of 1995; 44 U.S.C. Chapter 35, as amended; information collection, including (a) 49 CFR 1.49; and DOT Order 1351.29. SUMMARY: This document grants in full the Mazda Motor Corporation (Mazda) whether the proposed collection of Raymond R. Posten, information is necessary for the proper petition for exemption from the Federal Associate Administrator for Rulemaking. performance of the functions of the Motor Vehicle Theft Prevention [FR Doc. 2021–09985 Filed 5–11–21; 8:45 am] Standard (theft prevention standard) for Department, including whether the its confidential vehicle line beginning in information will have practical utility; BILLING CODE 4910–59–P model year (MY) 2023. The petition is (b) the accuracy of the Department’s granted because the agency has estimate of the burden of the proposed DEPARTMENT OF TRANSPORTATION determined that the antitheft device to information collection; (c) ways to be placed on the line as standard enhance the quality, utility and clarity National Highway Traffic Safety equipment is likely to be as effective in of the information to be collected; and Administration reducing and deterring motor vehicle (d) ways to minimize the burden of the theft as compliance with the parts- collection of information on Petition for Exemption From the marking requirements of the theft respondents, including the use of Federal Motor Vehicle Theft Prevention prevention standard. Mazda also automated collection techniques or Standard; Mazda Motor Corporation requested confidential treatment for other forms of information technology. specific information in its petition. AGENCY: National Highway Traffic Therefore, no confidential information Safety Administration (NHTSA), provided for purposes of this notice has Department of Transportation (DOT). been disclosed.

1 May 2019 National Industry-Specific https://www.bls.gov/oes/current/naics4_ 2 Table 1. Employer Costs for Employee Occupational Employment and Wage Estimates, 336100.htm#51-0000. Compensation by ownership, September 2020, NAICS 336100—Motor Vehicle Manufacturing, https://www.bls.gov/news.release/ecec.t01.htm.

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DATES: The exemption granted by this Section 543.8 establishes This grant of petition for exemption notice is effective beginning with the requirements for processing petitions for considers Mazda Motor Corporation’s 2023 model year. exemption from the theft prevention (Mazda) petition for its confidential FOR FURTHER INFORMATION CONTACT: standard. As stated in section 543.8(a), vehicle line beginning in MY 2023. Carlita Ballard, Office of International NHTSA processes any complete Mazda’s petition is granted under 49 Policy, Fuel Economy, and Consumer exemption petition. If NHTSA receives U.S.C. 33106 and 49 CFR 543.8(c), Programs, NHTSA, West Building, an incomplete petition, NHTSA will which state that if the Secretary of W43–439, NRM–310, 1200 New Jersey notify the petitioner of the deficiencies. Transportation (NHTSA, by delegation) Avenue SE, Washington, DC 20590. Ms. Once NHTSA receives a complete does not make a decision about a Ballard’s phone number is (202) 366– petition the agency will process it and, petition within 120 days of the petition 5222. Her fax number is (202) 493–2990. in accordance with section 543.8(b), submission, the petition shall be SUPPLEMENTARY INFORMATION: Under 49 will grant the petition if it determines deemed to be approved and the U.S.C. Chapter 331, the Secretary of that, based upon substantial evidence, manufacturer shall be exempt from the Transportation (and the National the standard equipment antitheft device standard for the line covered by the Highway Traffic Safety Administration is likely to be as effective in reducing petition for the subsequent model year. (NHTSA) by delegation) is required to and deterring motor vehicle theft as Separately, based on the information promulgate a theft prevention standard compliance with the parts-marking provided in Mazda’s petition, NHTSA to provide for the identification of requirements of part 541. has determined that the antitheft device certain motor vehicles and their major Section 543.8(c) requires NHTSA to to be placed on its vehicle line as replacement parts to impede motor issue its decision either to grant or to standard equipment is likely to be as vehicle theft. NHTSA promulgated deny an exemption petition not later effective in reducing and deterring regulations at 49 CFR part 541 (theft than 120 days after the date on which motor vehicle theft as compliance with prevention standard) to require parts- a complete petition is filed. If NHTSA the parts-marking requirements of the marking for specified passenger motor does not make a decision within the theft prevention standard. vehicles and light trucks. Pursuant to 49 120-day period, the petition shall be I. Specific Petition Content U.S.C. 33106, manufacturers that are deemed to be approved and the Requirements Under 49 CFR 543.6 subject to the parts-marking manufacturer shall be exempt from the Pursuant to 49 CFR part 543, requirements may petition NHTSA, by standard for the line covered by the Exemption from Vehicle Theft delegation, for an exemption for a line petition for the subsequent model year.2 Prevention, Mazda petitioned for an of passenger motor vehicles equipped Exemptions granted under part 543 exemption for its specified vehicle line with an antitheft device as standard apply only to the vehicle line or lines from the parts-marking requirements of equipment that NHTSA decides is likely that are subject to the grant and that are the theft prevention standard, beginning to be as effective in reducing and equipped with the antitheft device on in MY 2023. Mazda petitioned under 49 deterring motor vehicle theft as which the line’s exemption was based, CFR 543.6, Petition: Specific content compliance with the parts-marking and are effective for the model year requirements, which, as described requirements. In accordance with this beginning after the model year in which above, requires manufacturers to statute, NHTSA promulgated 49 CFR NHTSA issues the notice of exemption, provide specific information about the part 543, which establishes the process unless the notice of exemption specifies antitheft device installed as standard through which manufacturers may seek a later year. equipment on all vehicles in the line for an exemption from the theft prevention Sections 543.8(f) and (g) apply to the which an exemption is sought, the standard. manner in which NHTSA’s decisions on antitheft device’s capabilities, and the 49 CFR 543.5 provides general petitions are to be made known. Under reasons the petitioner believes the submission requirements for petitions section 543.8(f), if the petition is sought device to be as effective at reducing and and states that each manufacturer may under section 543.6, NHTSA publishes deterring theft as compliance with the petition NHTSA for an exemption of a notice of its decision to grant or deny parts-marking requirements. one vehicle line per model year. Among the exemption petition in the Federal More specifically, section 543.6(a)(1) other requirements, manufacturers must Register and notifies the petitioner in requires petitions to include a statement identify whether the exemption is writing. Under section 543.8(g), if the that an antitheft device will be installed sought under section 543.6 or section petition is sought under section 543.7, as standard equipment on all vehicles in 543.7. Under section 543.6, a NHTSA notifies the petitioner in writing the line for which the exemption is manufacturer may request an exemption of the agency’s decision to grant or deny sought. Under section 543.6(a)(2), each by providing specific information about the exemption petition. petition must list each component in the the antitheft device, its capabilities, and antitheft system, and include a diagram the reasons the petitioner believes the (1) The performance criteria (subsections 8 showing the location of each of those device to be as effective at reducing and through 21) of C.R.C, c. 1038.114, Theft Protection components within the vehicle. As deterring theft as compliance with the and Rollaway Prevention (in effect March 30, 2011), required by section 543.6(a)(3), each parts-marking requirements. Section as excerpted in appendix A of [part 543]; (2) National Standard of Canada CAN/ULC– petition must include an explanation of 543.7 permits a manufacturer to request S338–98, Automobile Theft Deterrent Equipment the means and process by which the an exemption under a more streamlined and Systems: Electronic Immobilization (May 1998); device is activated and functions, process if the vehicle line is equipped (3) United Nations Economic Commission for including any aspect of the device with an antitheft device (an Europe (UN/ECE) Regulation No. 97 (ECE R97), designed to: (1) Facilitate or encourage ‘‘immobilizer’’) as standard equipment Uniform Provisions Concerning Approval of Vehicle Alarm System (VAS) and Motor Vehicles with its activation by motorists; (2) attract that complies with one of the standards Regard to Their Alarm System (AS) in effect August attention to the efforts of an 1 specified in that section. 8, 2007; or unauthorized person to enter or move a (4) UN/ECE Regulation No. 116 (ECE R116), vehicle by means other than a key; (3) 1 49 CFR 543.7 specifies that the manufacturer Uniform Technical Prescriptions Concerning the must include a statement that their entire vehicle Protection of Motor Vehicles Against Unauthorized prevent defeating or circumventing the line is equipped with an immobilizer that meets Use in effect on February 10, 2009. device by an unauthorized person one of the following standards: 2 49 U.S.C. 33106(d). attempting to enter a vehicle by means

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other than a key; (4) prevent the low frequency (LF) antenna, radio water, dust, vibration, connector and operation of a vehicle which an frequency (RF) receiver and a low lead/lock strength, chemical resistance, unauthorized person has entered using frequency unit (LFU). The device will electromagnetic field, power line means other than a key; and (5) ensure not provide any visible or audible variations, DC stresses, electrostatic the reliability and durability of the indication of unauthorized vehicle entry discharge and push button start device.3 (i.e., flashing lights or horn alarm) as strength) and stated that it believes the In addition to providing information standard equipment; however, Mazda device is reliable and durable since it about the antitheft device and its stated that its device will incorporate a complied with its own specified functionality, petitioners must also security indicator light which will requirements for each test. Additionally, submit the reasons for their belief that provide a visual confirmation on the Mazda stated that its device is extremely the antitheft device will be effective in protection status of the antitheft device. reliable and durable because it is reducing and deterring motor vehicle Pursuant to section 543.6(a)(3), Mazda computer-based and does not rely on theft, including any theft data and other explained that there are two methods of any mechanical or moving parts. Mazda data that are available to the petitioner initiating the antitheft device operation further stated that any attempt to slam- and form a basis for that belief,4 and the process. Specifically, Mazda stated that pull its vehicle’s ignition will have no reasons for their belief that the agency the immobilizer system monitors two effect on a thief’s ability to start the should determine that the antitheft codes: (1) The transponder code, which vehicle without the correct code being device is likely to be as effective as the immobilizer control module checks transmitted to the electronic control compliance with the parts-marking with the transponder located in the modules. requirements of part 541 in reducing transmitter; and (2) the immobilizer Mazda provided data from the and deterring motor vehicle theft. In code, which the immobilizer control Highway Loss Data Institute (HLDI), support of this belief, the petitioners module checks with the powertrain’s National Crime Information Center should include any statistical data that electronic control module. Mazda also (NCIC), and Insurance Institute for are available to the petitioner and form stated that there are two means of Highway Safety (IIHS) on the the basis for the petitioner’s belief that checking the transponder code: (1) effectiveness of other similar antitheft a line of passenger motor vehicles When the immobilizer control module devices installed on vehicle lines in equipped with the antitheft device is communicates with the transmitter support of its belief that its device will likely to have a theft rate equal to or less which includes a transponder by LF be at least as effective as those than that of passenger motor vehicles of antenna and receives a reply of comparable devices. Specifically, Mazda transmitter in the RF receiver; and (2) the same, or a similar, line which have stated that its device was installed on when the immobilizer control module parts marked in compliance with part certain MY 1996 Ford vehicles as 5 communicates with the transponder by 541. standard equipment, (i.e., all Ford coil antenna which is located in the The following sections describe Mustang GT and Cobra models, Ford push button start. If the transponder Mazda’s petition information provided Taurus LX, and SHO models and Ford code matches with the immobilizer pursuant to 49 CFR part 543, Exemption Sable LS models). In MY 1997, Mazda control module by either method from Vehicle Theft Prevention. To the installed its immobilizer device on the mentioned above, and the ignition is extent that specific information in entire Ford Mustang vehicle line as turned to the ON position, the Mazda’s petition is subject to a properly standard equipment. When comparing filed confidentiality request, that immobilizer control module checks the powertrain’s electronic control module 1995 model year Mustang vehicle thefts information was not disclosed as part of (without immobilizers) with MY 1997 this notice.6 with immobilizer code. Mazda further stated that the vehicle’s engine can only Mustang vehicle thefts (with II. Mazda’s Petition for Exemption be started if the immobilizer code immobilizers), Mazda referenced the National Crime Information Center’s In a petition dated November 26, matches the code previously (NCIC) theft information which showed 2020, Mazda requested an exemption programmed into the immobilizer that there was a 70% reduction in theft from the parts-marking requirements of control module. If the immobilizer code experienced when comparing MY 1997 the theft prevention standard for its does not match, the engine will be Mustang vehicle thefts (with confidential vehicle line beginning with disabled. Communications between the immobilizers) to MY 1995 Mustang MY 2023. immobilizer system control function vehicle thefts (without immobilizers). In its petition, Mazda provided a and the powertrain’s electronic control Mazda recognized that NHTSA detailed description and diagram of the module are encrypted. Mazda also requested data for vehicle sets that are identity, design, and location of the stated that there are more than 15 x 10 6 as similar as possible to the vehicle for components of the antitheft device for different transponder codes, and each which the petition is written; 7 the confidential vehicle line. Mazda transponder is hard coded with a however, stated that its MY 2023 confidential unique code at the time of manufacture. Mazda stated that there is no vehicle line will be installed with a As required in section 543.6(a)(3)(v), comparable data for a Mazda vehicle of passive, transponder based, electronic Mazda provided information on the the same body style before and after the engine immobilizer antitheft device as reliability and durability of its proposed implementation of an immobilizer standard equipment. Key components of device. To ensure reliability and system, because all of Mazda’s similar its antitheft device will include a durability of the device, Mazda vehicles have been equipped with a powertrain control module (PCM), conducted tests based on its own standard immobilizer from the onset of immobilizer control module, security specified standards. Mazda provided a manufacture. In light of these indicator light, coil antenna, transmitter detailed list of the tests conducted (i.e., considerations, Mazda stated that the with transponder key (transponder key), low/high temperature exposure NCIC and HLDI data provided operation, high temperature endurance, supported its belief that the immobilizer 3 49 CFR 543.6(a)(3). thermal cycling, thermal shock system described in its petition will 4 49 CFR 543.6(a)(4). resistance, thermal shock endurance, prove to be as, if not more effective, 5 49 CFR 543.6(a)(5). humidity temperature cycling, high 6 49 CFR 512.20(a). temperature and humidity endurance, 7 See 85 FR 55368 (Sep. 8, 2020).

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than the parts marking requirements of (marking of major component parts and device to be placed on the line as part 541 in reducing vehicle theft. replacement parts). standard equipment is likely to be as NHTSA notes that if a manufacturer effective in reducing and deterring III. Decision To Grant the Petition to which an exemption has been granted motor vehicle theft as compliance with Pursuant to 49 U.S.C. 33106 and 49 wishes in the future to modify the the parts-marking requirements of the CFR 543.8(b), the agency grants a device on which the exemption is theft prevention standard. Subaru also petition for exemption from the parts- based, the company may have to submit requested confidential treatment for marking requirements of part 541, either a petition to modify the exemption. specific information in its petition. in whole or in part, if it determines that, Section 543.8(d) states that a part 543 Therefore, no confidential information based upon substantial evidence, the exemption applies only to vehicles that provided for purposes of this notice has standard equipment antitheft device is belong to a line exempted under this been disclosed. likely to be as effective in reducing and part and equipped with the antitheft DATES: The exemption granted by this deterring motor vehicle theft as device on which the line’s exemption is notice is effective beginning with the compliance with the parts-marking based. Further, section 543.10(c)(2) 2022 model year. requirements of part 541 or if deemed provides for the submission of petitions FOR FURTHER INFORMATION CONTACT: approved under 49 U.S.C. 33106(d). As ‘‘to modify an exemption to permit the Carlita Ballard, Office of International discussed above, in this case, Mazda’s use of an antitheft device similar to but Policy, Fuel Economy, and Consumer petition is granted under 49 U.S.C. differing from the one specified in the Programs, NHTSA, West Building, 33106(d). 8 exemption.’’ W43–439, NRM–310, 1200 New Jersey However, separately, NHTSA also For the foregoing reasons, the agency Avenue SE, Washington, DC 20590. Ms. finds that Mazda has provided adequate hereby announces a grant in full of Ballard’s phone number is (202) 366– reasons for its belief that the antitheft Mazda’s petition for exemption for the 5222. Her fax number is (202) 493–2990. device for its vehicle line is likely to be confidential vehicle line from the parts- as effective in reducing and deterring marking requirements of 49 CFR part SUPPLEMENTARY INFORMATION: Under 49 motor vehicle theft as compliance with 541, beginning with its MY 2023 U.S.C. Chapter 331, the Secretary of the parts-marking requirements of the vehicles. Transportation (and the National theft prevention standard. This Highway Traffic Safety Administration Issued under authority delegated in 49 CFR (NHTSA) by delegation) is required to conclusion is based on the information 1.95 and 501.8. promulgate a theft prevention standard Mazda provided about its antitheft Raymond R. Posten, device. NHTSA believes, based on to provide for the identification of Associate Administrator for Rulemaking. Mazda’s supporting evidence, that the certain motor vehicles and their major antitheft device described for its vehicle [FR Doc. 2021–09983 Filed 5–11–21; 8:45 am] replacement parts to impede motor line is likely to be as effective in BILLING CODE 4910–59–P vehicle theft. NHTSA promulgated reducing and deterring motor vehicle regulations at 49 CFR part 541 (theft prevention standard) to require parts- theft as compliance with the parts- DEPARTMENT OF TRANSPORTATION marking requirements of the theft marking for specified passenger motor prevention standard. National Highway Traffic Safety vehicles and light trucks. Pursuant to 49 The agency concludes that Mazda’s Administration U.S.C. 33106, manufacturers that are antitheft device will provide four types subject to the parts-marking of performance features listed in section Petition for Exemption from the requirements may petition NHTSA, by 543.6(a)(3): Promoting activation; Federal Motor Vehicle Theft Prevention delegation, for an exemption for a line preventing defeat or circumvention of Standard; North American Subaru, of passenger motor vehicles equipped the device by unauthorized persons; INC. with an antitheft device as standard preventing operation of the vehicle by equipment that NHTSA decides is likely unauthorized entrants; and ensuring the AGENCY: National Highway Traffic to be as effective in reducing and reliability and durability of the device. Safety Administration (NHTSA), deterring motor vehicle theft as The agency notes that 49 CFR part Department of Transportation (DOT). compliance with the parts-marking 541, Appendix A–1, identifies those ACTION: Grant of petition for exemption. requirements. In accordance with this lines that are exempted from the theft statute, NHTSA promulgated 49 CFR SUMMARY: This document grants in full prevention standard for a given model the North American Subaru, Inc.’s part 543, which establishes the process year. 49 CFR 543.8(f) contains (Subaru) petition for exemption from through which manufacturers may seek publication requirements incident to the the Federal Motor Vehicle Theft an exemption from the theft prevention disposition of all part 543 petitions. Prevention Standard (theft prevention standard. 49 CFR 543.5 provides general Advanced listing, including the release standard) for its Toyota GR 86 vehicle submission requirements for petitions of future product nameplates, the line beginning in model year (MY) 2022. and states that each manufacturer may beginning model year for which the The petition is granted because the petition NHTSA for an exemption of petition is granted and a general agency has determined that the antitheft description of the antitheft device is one vehicle line per model year. Among necessary in order to notify law 8 The agency wishes to minimize the other requirements, manufacturers must enforcement agencies of new vehicle administrative burden that section 543.10(c)(2) identify whether the exemption is lines exempted from the parts-marking could place on exempted vehicle manufacturers sought under section 543.6 or section requirements of the theft prevention and itself. The agency did not intend in drafting 543.7. Under section 543.6, a part 543 to require the submission of a modification standard. petition for every change to the components or manufacturer may request an exemption If Mazda decides not to use the design of an antitheft device. The significance of by providing specific information about exemption for its requested vehicle line, many such changes could be de minimis. Therefore, the antitheft device, its capabilities, and the manufacturer must formally notify NHTSA suggests that if a manufacturer with an the reasons the petitioner believes the exemption contemplates making any changes, the the agency. If such a decision is made, effects of which might be characterized as de device to be as effective at reducing and the line must be fully marked as minimis, it should consult the agency before deterring theft as compliance with the required by 49 CFR 541.5 and 541.6 preparing and submitting a petition to modify. parts-marking requirements. Section

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543.7 permits a manufacturer to request section 543.8(f), if the petition is sought as standard equipment on all vehicles in an exemption under a more streamlined under section 543.6, NHTSA publishes the line for which the exemption is process if the vehicle line is equipped a notice of its decision to grant or deny sought. Under section 543.6(a)(2), each with an antitheft device (an the exemption petition in the Federal petition must list each component in the ‘‘immobilizer’’) as standard equipment Register and notifies the petitioner in antitheft system, and include a diagram that complies with one of the standards writing. Under section 543.8(g), if the showing the location of each of those specified in that section.1 petition is sought under section 543.7, components within the vehicle. As Section 543.8 establishes NHTSA notifies the petitioner in writing required by section 543.6(a)(3), each requirements for processing petitions for of the agency’s decision to grant or deny petition must include an explanation of exemption from the theft prevention the exemption petition. the means and process by which the This grant of petition for exemption standard. As stated in section 543.8(a), device is activated and functions, considers North American Subaru, Inc.’s NHTSA processes any complete including any aspect of the device (Subaru) petition for its Toyota GR 86 exemption petition. If NHTSA receives designed to: (1) Facilitate or encourage an incomplete petition, NHTSA will vehicle line beginning in MY 2022. Subaru is the manufacturer of the its activation by motorists; (2) attract notify the petitioner of the deficiencies. attention to the efforts of an Once NHTSA receives a complete Toyota GR 86 vehicle line as defined in unauthorized person to enter or move a petition the agency will process it and, 49 U.S.C. 32101(5), and is the vehicle by means other than a key; (3) in accordance with section 543.8(b), manufacturer of the vehicle line as prevent defeating or circumventing the will grant the petition if it determines indicated on the label required by 49 that, based upon substantial evidence, CFR part 567. Accordingly, NHTSA device by an unauthorized person the standard equipment antitheft device determined that Subaru can use its one attempting to enter a vehicle by means is likely to be as effective in reducing exemption request per model year for other than a key; (4) prevent the and deterring motor vehicle theft as the Toyota GR 86 vehicle line beginning operation of a vehicle which an compliance with the parts-marking in MY 2022. unauthorized person has entered using requirements of part 541. Subaru’s petition is granted under 49 means other than a key; and (5) ensure Section 543.8(c) requires NHTSA to U.S.C. 33106 and 49 CFR 543.8(c), the reliability and durability of the issue its decision either to grant or to which state that if the Secretary of device.3 Transportation (NHTSA, by delegation) deny an exemption petition not later In addition to providing information does not make a decision about a than 120 days after the date on which about the antitheft device and its a complete petition is filed. If NHTSA petition within 120 days of the petition submission, the petition shall be functionality, petitioners must also does not make a decision within the submit the reasons for their belief that 120-day period, the petition shall be deemed to be approved and the manufacturer shall be exempt from the the antitheft device will be effective in deemed to be approved and the standard for the line covered by the reducing and deterring motor vehicle manufacturer shall be exempt from the petition for the subsequent model year. theft, including any theft data and other standard for the line covered by the Separately, based on the information data that are available to the petitioner petition for the subsequent model year.2 provided in Subaru’s petition, NHTSA and form a basis for that belief,4 and the Exemptions granted under part 543 has determined that the antitheft device reasons for their belief that the agency apply only to the vehicle line or lines to be placed on its vehicle line as should determine that the antitheft that are subject to the grant and that are standard equipment is likely to be as device is likely to be as effective as equipped with the antitheft device on effective in reducing and deterring compliance with the parts-marking which the line’s exemption was based, motor vehicle theft as compliance with requirements of part 541 in reducing and are effective for the model year the parts-marking requirements of the and deterring motor vehicle theft. In beginning after the model year in which theft prevention standard. support of this belief, the petitioners NHTSA issues the notice of exemption, unless the notice of exemption specifies I. Specific Petition Content should include any statistical data that a later year. Requirements Under 49 CFR 543.6 are available to the petitioner and form Sections 543.8(f) and (g) apply to the the basis for the petitioner’s belief that Pursuant to 49 CFR part 543, a line of passenger motor vehicles manner in which NHTSA’s decisions on Exemption from Vehicle Theft petitions are to be made known. Under equipped with the antitheft device is Prevention, Subaru petitioned for an likely to have a theft rate equal to or less exemption for its specified vehicle line 1 than that of passenger motor vehicles of 49 CFR 543.7 specifies that the manufacturer from the parts-marking requirements of must include a statement that their entire vehicle the same, or a similar, line which have the theft prevention standard, beginning line is equipped with an immobilizer that meets parts marked in compliance with part one of the following standards: in MY 2022. Subaru petitioned under 49 541.5 (1) The performance criteria (subsections 8 CFR 543.6, Petition: Specific content through 21) of C.R.C, c. 1038.114, Theft Protection requirements, which, as described The following sections describe and Rollaway Prevention (in effect March 30, 2011), Subaru’s petition information provided as excerpted in appendix A of [part 543]; above, requires manufacturers to (2) National Standard of Canada CAN/ULC– provide specific information about the pursuant to 49 CFR part 543, Exemption S338–98, Automobile Theft Deterrent Equipment antitheft device installed as standard from Vehicle Theft Prevention. To the and Systems: Electronic Immobilization (May 1998); equipment on all vehicles in the line for extent that specific information in (3) United Nations Economic Commission for which an exemption is sought, the Subaru’s petition is subject to a properly Europe (UN/ECE) Regulation No. 97 (ECE R97), Uniform Provisions Concerning Approval of Vehicle antitheft device’s capabilities, and the filed confidentiality request, that Alarm System (VAS) and Motor Vehicles with reasons the petitioner believes the information was not disclosed as part of Regard to Their Alarm System (AS) in effect August device to be as effective at reducing and this notice.6 8, 2007; or deterring theft as compliance with the (4) UN/ECE Regulation No. 116 (ECE R116), parts-marking requirements. 3 49 CFR 543.6(a)(3). Uniform Technical Prescriptions Concerning the 4 Protection of Motor Vehicles Against Unauthorized More specifically, section 543.6(a)(1) 49 CFR 543.6(a)(4). Use in effect on February 10, 2009. requires petitions to include a statement 5 49 CFR 543.6(a)(5). 2 49 U.S.C. 33106(d). that an antitheft device will be installed 6 49 CFR 512.20(a).

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II. Subaru’s Petition for Exemption pressing the brake pedal, random codes immobilizer system is no less effective In a petition dated November 11, are then transmitted to the access key than those devices installed on lines for 2020, Subaru requested an exemption from the keyless access ECU through the which NHTSA has already granted full from the parts-marking requirements of interior antenna. Once the access key exemptions. receives the signal, it returns the the theft prevention standard for the III. Decision to Grant the Petition encrypted code. When pushing the push Toyota GR 86 vehicle line beginning Pursuant to 49 U.S.C. 33106 and 49 with MY 2022. button ignition switch once again, the power is turned off and the security CFR 543.8(b), the agency grants a In its petition, Subaru provided a petition for exemption from the parts- detailed description and diagram of the indicator lamp blinks. Subaru stated that this method of activation will marking requirements of part 541, either identity, design, and location of the in whole or in part, if it determines that, components of the antitheft device for facilitate and encourage its activation by motorists because it requires nothing based upon substantial evidence, the the Toyota GR 86 vehicle line. Subaru standard equipment antitheft device is stated that its MY 2022 Toyota GR 86 more than the removal of the key from the ignition switch when the vehicle is likely to be as effective in reducing and vehicle line will be installed with an deterring motor vehicle theft as engine immobilizer device as standard not being used. As required in section 543.6(a)(3)(v), compliance with the parts-marking equipment, as required by 543.6(a)(1). Subaru provided information on the requirements of part 541 or if deemed Subaru also stated it will offer a ‘‘Smart reliability and durability of its proposed approved under 49 U.S.C. 33106(d). As Key’’ system on all trim lines, which device. To ensure reliability and discussed above, in this case, Subaru’s includes keyless access and push start durability of the device, Subaru petition is granted under 49 U.S.C. functions. Specifically, key components conducted tests based on its own 33106(d). of the ‘‘smart entry’’ system will include specified standards and provided a However, separately, NHTSA also a keyless access engine control unit detailed list of the tests conducted. finds that Subaru has provided adequate (ECU), steering lock ECU, engine ECU, Subaru stated that it believes that its reasons for its belief that the antitheft an interior antenna, push button device is reliable and durable because it device for its vehicle line is likely to be ignition switch, and an access key. complied with its own specific design as effective in reducing and deterring Subaru also stated that there is a standards and the antitheft device is motor vehicle theft as compliance with diagnosis tool used to perform a key ID installed on other vehicle lines for the parts-marking requirements of the code registration to the immobilizer which the agency has granted a parts- theft prevention standard. This module. Subaru stated that its antitheft marking exemption. conclusion is based on the information device will also include an alarm Subaru stated that its theft rates have Subaru provided about its antitheft system as standard equipment. Subaru been low per the National Insurance device. NHTSA believes, based on stated that its alarm system will monitor Crime Bureau’s 2019 report on Subaru’s supporting evidence, that the door status and key ID, and opening of America’s 10 most stolen vehicles. antitheft device described for its vehicle a door or hood will activate the alarm However, Subaru compared its line is likely to be as effective in system. Subaru further stated that visual proposed device to other Subaru reducing and deterring motor vehicle and audio features will attract attention antitheft devices that NHTSA has theft as compliance with the parts- to the efforts of an unauthorized person determined to be as effective in marking requirements of the theft to enter or move the vehicle by reducing and deterring motor vehicle prevention standard. sounding the vehicle’s horn and theft as would compliance with the The agency concludes that Subaru’s illuminating the 4-way flashing hazard parts-marking requirements. antitheft device will provide the five lamps. Specifically, Subaru stated that the theft types of performance features listed in Pursuant to section 543.6(a)(3), rate of the MY 2008 Impreza (not parts section 543.6(a)(3): Promoting Subaru explained the means and marked, standard engine immobilizer) activation; attracting attention to the process by which the immobilizer decreased by almost 51% as compared efforts of unauthorized persons to enter device is activated and functions. to the MY 2007 Impreza (parts marked or operate a vehicle by means other than Subaru stated that its antitheft system with optional engine immobilizer). a key; preventing defeat or and immobilization features are Subaru stated that the antitheft system circumvention of the device by designed and constructed within the included on the Toyota GR 86 vehicle unauthorized persons; preventing vehicle’s overall CAN (controller area line is the same system employed on the operation of the vehicle by network) electrical architecture which Subaru Ascent car line, for which unauthorized entrants; and ensuring the means the antitheft system cannot be NHTSA determined that the system was reliability and durability of the device. separated by rerouting or tapping into likely as effective in reducing and The agency notes that 49 CFR part particular wires or connectors. Subaru deterring motor vehicle theft as 541, Appendix A–1, identifies those further stated that the immobilization compliance with the parts-marking lines that are exempted from the theft features will prevent operation of the requirements of the theft prevention prevention standard for a given model vehicle by preventing the starting or standard.7 year. 49 CFR 543.8(f) contains operation of the engine even if an Subaru also stated that the National publication requirements incident to the unauthorized person was to gain entry Crime Information Center’s (NCIC) theft disposition of all part 543 petitions. into the vehicle. data showed that there was a 70% Advanced listing, including the release Subaru stated that its Toyota GR 86 reduction in theft experienced when of future product nameplates, the ‘‘smart key’’ system is activated when comparing the MY 1987 Ford Mustang beginning model year for which the the ignition is at the ‘‘OFF’’ position or vehicle thefts (with immobilizers) to MY petition is granted and a general the door is opened/closed while 1995 Ford Mustang vehicle thefts description of the antitheft device is propulsion system is off and ignition is (without immobilizers). On the basis of necessary in order to notify law at the ‘‘ON’’ or ‘‘ACC’’ position. the above and other cited comparisons, enforcement agencies of new vehicle Deactivation occurs after the driver gets Subaru has concluded that its proposed lines exempted from the parts-marking in the vehicle with the access key and requirements of the theft prevention pushes the button ignition switch while 7 82 FR 57650 (Dec. 06, 2017). standard.

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If Subaru decides not to use the DEPARTMENT OF VETERANS Title: Certification of School exemption for its requested vehicle line, AFFAIRS Attendance or Termination (VA Forms the manufacturer must formally notify 21–8960 and 21–8960–1). the agency. If such a decision is made, [OMB Control No. 2900–0458] OMB Control Number: 2900–0458. the line must be fully marked as Type of Review: Reinstatement of a required by 49 CFR 541.5 and 541.6 Agency Information Collection Activity previously approved collection. (marking of major component parts and Under OMB Review: Certification of Abstract: VA compensation and replacement parts). School Attendance or Termination NHTSA notes that if a manufacturer pension programs require current to which an exemption has been granted AGENCY: Veterans Benefits information to determine eligibility for wishes in the future to modify the Administration, Department of Veterans benefits. VA Forms 21–8960 and 21– device on which the exemption is Affairs. 8960–1 solicit information that is needed to determine continued benefit based, the company may have to submit ACTION: Notice. a petition to modify the exemption. eligibility for schoolchildren between the ages of 18 and 23. If the collection Section 543.8(d) states that a part 543 SUMMARY: In compliance with the were not conducted or were conducted exemption applies only to vehicles that Paperwork Reduction Act (PRA) of less frequently, VA would be unable to belong to a line exempted under this 1995, this notice announces that the verify continued entitlement in a timely part and equipped with the antitheft Veterans Benefits Administration manner, and increased overpayments device on which the line’s exemption is (VBA), Department of Veterans Affairs, would result. based. Further, section 543.10(c)(2) will submit the collection of provides for the submission of petitions information abstracted below to the The burden estimate for VA Forms ‘‘to modify an exemption to permit the Office of Management and Budget 21–8960 and 21–8960–1 has decreased use of an antitheft device similar to but (OMB) for review and comment. The as the number of respondent total has differing from the one specified in the PRA submission describes the nature of reduced over the past year. exemption.’’ 8 the information collection and its An agency may not conduct or For the foregoing reasons, the agency expected cost and burden and it sponsor, and a person is not required to hereby announces a grant in full of includes the actual data collection respond to a collection of information Subaru’s petition for exemption for the instrument. unless it displays a currently valid OMB Toyota GR 86 vehicle line from the control number. The Federal Register parts-marking requirements of 49 CFR DATES: Written comments and Notice with a 60-day comment period part 541, beginning with its MY 2022 recommendations for the proposed soliciting comments on this collection vehicles. information collection should be sent of information was published at 86 FR within 30 days of publication of this Issued under authority delegated in 49 CFR 35 on February 24, 2021, pages 11385 1.95 and 501.8. notice to www.reginfo.gov/public/do/ and 11386. PRAMain. Find this particular Affected Public: Individuals or Raymond R. Posten, information collection by selecting Households. Associate Administrator for Rulemaking. ‘‘Currently under 30-day Review—Open [FR Doc. 2021–09981 Filed 5–11–21; 8:45 am] for Public Comments’’ or by using the Estimated Annual Burden: 1,543. BILLING CODE 4910–59–P search function. Refer to ‘‘OMB Control Estimated Average Burden per No. 2900–0458.’’ Respondent: 10 minutes. 8 The agency wishes to minimize the FOR FURTHER INFORMATION CONTACT: Frequency of Response: Once. administrative burden that section 543.10(c)(2) Estimated Number of Respondents: could place on exempted vehicle manufacturers Maribel Aponte, Office of Enterprise and itself. The agency did not intend in drafting and Integration, Data Governance 9,259. part 543 to require the submission of a modification Analytics (008), 1717 H Street NW, By direction of the Secretary. petition for every change to the components or Washington, DC 20006, (202) 266–4688 design of an antitheft device. The significance of Maribel Aponte, many such changes could be de minimis. Therefore, or email [email protected]. Please VA PRA Clearance Officer, Office of NHTSA suggests that if a manufacturer with an refer to ‘‘OMB Control No. 2900–0458’’ Enterprise and Integration, Data Governance exemption contemplates making any changes, the in any correspondence. Analytics, Department of Veterans Affairs. effects of which might be characterized as de minimis, it should consult the agency before SUPPLEMENTARY INFORMATION: [FR Doc. 2021–10032 Filed 5–11–21; 8:45 am] preparing and submitting a petition to modify. Authority: 38 U.S.C. 101 (4). BILLING CODE 8320–01–P

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Vol. 86 Wednesday, No. 90 May 12, 2021

Part II

The President

Proclamation 10207—Mother’s Day, 2021

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Federal Register Presidential Documents Vol. 86, No. 90

Wednesday, May 12, 2021

Title 3— Proclamation 10207 of May 7, 2021

The President Mother’s Day, 2021

By the President of the United States of America

A Proclamation Each year on the second Sunday in May, we take time to thank and celebrate mothers across America—those who give us life and believe in us, so we can believe in ourselves. Throughout our history, even as they have nurtured and guided us, mothers have built, shaped, led, and sustained our Nation with selflessness and courage. Like so many fellow Americans observing this day without their Moms with them, I will spend this Mother’s Day missing my own mom, Catherine Eugenia ‘‘Jean’’ Finnegan Biden. She taught me about the importance of family, loyalty, and faith. Even now, I hear her voice reminding me that everyone is equal and that we are all defined by our sense of honor, duty, and courage. Her immeasurable strength lives on in all of her children, her grandchildren, her great-grandchildren, and the many other lives that she touched. I will also spend this Mother’s Day honoring the love of my life and the life of my love, Jill. In the many years of our marriage, she has healed our family, guided us through unimaginable hardships, and brought us untold joy and laughter. Her strength and determination have been our bedrock, and her warmth holds us all together. Through their unconditional love, mothers shape our lives and help us become the people we hope to be. We especially thank the mothers who have led us through the COVID–19 pandemic. From the earliest days of this crisis, so many mothers across our country have worked essential jobs, borne the brunt of our caregiving crisis, and selflessly provided support and comfort in a time of anxiety and fear. For many families, mothers took on the full-time role of teacher and caregiver when our schools and child care facilities were closed or operating remotely. In fact, this year, millions of moms left the workforce or deferred their education in order to provide care. New mothers faced pregnancy and childbirth without family and friends to support them—exacerbating a preexisting maternal health crisis which disproportionately impacts Black and Native American families. On Mother’s Day, we also honor those who have suffered the profound loss of the life of a child and those grappling with uncertainty in hopes of becoming mothers someday. We also recognize that this will be the first Mother’s Day for many families who lost their Mom due to COVID–19 and other diseases and cruel twists of fate of this past year. May God bless their memory and may this day fall gently on their loved ones left behind. When we support mothers, we support the prosperity, security, and well- being of our entire Nation. That’s why my Administration is committed to fighting for safe and equitable workplaces, addressing barriers women face at work, closing the gender wage and wealth gaps, and making quality child care affordable so parents can work, knowing their children are in good hands. We’ve already begun this work through the American Rescue Plan’s historic reductions in child poverty, ground-breaking investments in child care, and

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expanded support for families with children. Today, we are working to pass once-in-a-generation investments in our Nation’s future through the American Jobs Plan and the American Families Plan. With these bills, we will modernize our schools, make it easier to care for aging loved-ones, create millions of good jobs, rebuild our country’s infrastructure, and strengthen our economic competitiveness, so that all families have the oppor- tunities they need to thrive. Our Nation would not be where we are today without the foundations built by mothers. This Mother’s Day, let us honor not only our own moms for their many contributions to our lives, but all mothers whose arms have cradled new generations and whose many gifts, unselfishly given, have blessed us all. The Congress, by joint resolution approved May 8, 1914 (38 Stat. 770), has designated the second Sunday in May each year as ‘‘Mother’s Day’’ and requested the President to call for its appropriate observance. NOW, THEREFORE, I, JOSEPH R. BIDEN JR., President of the United States of America, by virtue of the authority vested in me by the Constitution and the laws of the United States, do hereby proclaim May 9, 2021, as Mother’s Day. I urge all Americans to express their love, respect, and gratitude to mothers everywhere, including the figures in our lives who nurture, guide, and sacrifice for us in the ways that mothers do. I call upon all citizens to observe this day with appropriate programs, ceremonies, and activities. IN WITNESS WHEREOF, I have hereunto set my hand this seventh day of May, in the year of our Lord two thousand twenty-one, and of the Independence of the United States of America the two hundred and forty- fifth.

[FR Doc. 2021–10215 Filed 5–11–21; 11:15 am] Billing code 3295–F1–P

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Reader Aids Federal Register Vol. 86, No. 90 Wednesday, May 12, 2021

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16 CFR 24492 153...... 24140 228...... 23241 117...... 23278, 23609 Proposed Rules: 155...... 24140 229...... 23241 165 ...... 23279, 23611, 23613, Ch. II ...... 25817 156...... 24140 230...... 23241 23865, 24710, 25949 158...... 24140 231...... 23241 17 CFR 401...... 23241 184...... 24140 233...... 23241 Proposed Rules: 234...... 23241 232...... 25803 46 CFR 239...... 25803 117...... 23639, 23880 235...... 23241 249...... 25803 165...... 24807, 25830 221...... 23241 236...... 23241 307...... 23241 237...... 23241 269...... 25803 34 CFR 274...... 25803 340...... 23241 238...... 23241 Proposed Rules: 356...... 23241 239...... 23241 Proposed Rules: Ch. II ...... 23304 240...... 24364 Proposed Rules: 240...... 23241 Ch. II ...... 23876 241...... 23241 38 CFR 19 CFR 242...... 23241 17...... 24494 47 CFR 243...... 23241 Ch. I ...... 23277 2...... 23281, 23614 244...... 23241 39 CFR 20 CFR 15...... 23281 272...... 23241 3...... 24712 20...... 23614 386...... 23241 Proposed Rules: 10...... 24712 578...... 23241 655...... 24368 68...... 23614 73 ...... 23866, 23868, 24339, 1570...... 23629 40 CFR 21 CFR 24510, 24741 1582...... 23629 9...... 24328 90...... 23281 1308...... 23602, 24487 Proposed Rules: 52 ...... 24499, 24500, 24502, 95...... 23281 1310...... 24703 Ch. I ...... 23876 24503, 24505, 24507, 24713, Proposed Rules: Ch. II ...... 23876 Proposed Rules: 24715, 24717, 24718, 24726, 15...... 23323 Ch. III ...... 23876 573...... 24564 24728, 25951, 25954 73 ...... 23340, 24837, 25978, Ch. V...... 23876 62...... 24730 22 CFR 25979 531...... 25980 82...... 24444 90...... 23323 533...... 25980 228...... 24708 180...... 24731, 25956 95...... 23323 Ch. VI...... 23876 721...... 24328 23 CFR Ch. VII...... 23876 725...... 24328 48 CFR Ch. VIII...... 23876 Proposed Rules: Proposed Rules: Proposed Rules: Ch. X...... 23876 Ch. I ...... 23876 52 ...... 24564, 24569, 24809, Ch. 12 ...... 23876 Ch. XI...... 23876 Ch. II ...... 23876 24829, 24835, 25978 Ch. III ...... 23876 81...... 23309 49 CFR 50 CFR 107...... 23241 26 CFR 42 CFR 171...... 23241 17...... 23869, 25806 53...... 23865 37...... 24336 190...... 23241 218...... 24340 412...... 24735 622...... 24742 29 CFR 209...... 23241 510...... 23496 213...... 23241 635...... 24359 780...... 24303 Proposed Rules: 214...... 23241 648 ...... 23633, 24360, 24745 788...... 24303 412...... 25070 215...... 23241 660...... 23872 795...... 24303 413...... 25070 216...... 23241 665...... 24511 425...... 25070 217...... 23241 679...... 24746 30 CFR 455...... 25070 218...... 23241 Proposed Rules: 250...... 23606 495...... 25070 219...... 23241 10...... 24573 220...... 23241 17...... 23882, 25833 31 CFR 44 CFR 221...... 23241 20...... 23641 Proposed Rules: 64...... 24739 222...... 23241 32...... 23794 100...... 23877 223...... 23241 71...... 23794 45 CFR 224...... 23241 224...... 23657 33 CFR 147...... 24140 225...... 23241 635...... 25992 100 ...... 23608, 23865, 24326, 150...... 24140 227...... 23241 660...... 23659

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