Vol. 86 Tuesday No. 49 March 16, 2021

Pages 14363–14524

OFFICE OF THE FEDERAL REGISTER

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Contents Federal Register Vol. 86, No. 49

Tuesday, March 16, 2021

Agriculture Department Education Department See Animal and Plant Health Inspection Service RULES NOTICES Final Priority and Definitions: Request for Comments: American Indian Vocational Rehabilitation Training and on Tackling the Climate Crisis at Home Technical Assistance Center, 14374–14379 and Abroad, 14403–14404 NOTICES Applications for New Awards: Animal and Plant Health Inspection Service American Indian Vocational Rehabilitation Training and NOTICES Technical Assistance Center, 14414–14420 Agency Information Collection Activities; Proposals, Submissions, and Approvals: Election Assistance Commission National Animal Health Monitoring System; On-Farm NOTICES Monitoring of Antimicrobial Use and Resistance in Agency Organization, Procedure, and Practice: U.S. Broiler Production Study, 14404–14405 New Agency Seal, 14420

Bureau of Consumer Financial Protection Energy Department RULES See Federal Energy Regulatory Commission Equal Credit Opportunity (Regulation B): on the Bases of and Environmental Protection Agency Identity, 14363–14366 PROPOSED RULES Air Quality State Implementation Plans; Approvals and Census Bureau Promulgations: NOTICES Rescission of the Source-Specific Federal Implementation Agency Information Collection Activities; Proposals, Plan for Navajo Generating Station, Navajo Nation, Submissions, and Approvals: 14392–14396 Census Employment Application; Additional Applicant Texas; Revisions to the Texas Diesel Emissions Reduction Information Form, 14405–14406 Incentive Program, 14396–14398 Regulation of Persistent, Bioaccumulative, and Toxic Children and Families Administration Chemicals Under the Toxic Substances Control Act, NOTICES 14398–14401 Agency Information Collection Activities; Proposals, Submissions, and Approvals: Federal Aviation Administration Annual Statistical Report on Children in Foster Homes RULES and Children in Families Receiving Payment in Airworthiness Directives: Excess of the Poverty Income Level From a State Bell Textron Canada Limited Helicopters, 14366–14370 Program Funded Under the Social Security Act, PROPOSED RULES 14431 Special Conditions: Social Services Block Grant Post-Expenditure Report, Pre- Haeco Cabin Solutions, Boeing Commercial Airplanes Expenditure Report, and Intended Use Plan, 14432– Model 737–800 Airplane; Structure-Mounted 14433 Airbags, 14387–14389 Meetings: NOTICES Community-Based Family Resource and Support Grants, Agency Information Collection Activities; Proposals, 14431–14432 Submissions, and Approvals: High Density Traffic Airports; Slot Allocation and Coast Guard Transfer Methods, 14515–14516 PROPOSED RULES Petition for Exemption; Summary: Security Zone: Airlines for America, 14514, 14516 North Atlantic Ocean, Approaches to Ocean City, MD, 14389–14392 Federal Communications Commission PROPOSED RULES Commerce Department Television Broadcasting Services: See Census Bureau Augusta, GA; Correction, 14401 See Foreign-Trade Zones Board NOTICES See International Trade Administration Privacy Act; Matching Program, 14426–14428, 14430–14431 See National Oceanic and Atmospheric Administration Privacy Act; Systems of Records, 14428–14430

Drug Enforcement Administration Federal Energy Regulatory Commission NOTICES NOTICES Bulk Manufacturer of Controlled Substances Application: Application: Cambridge Isotope Lab; Correction, 14471 Kinet, Inc., 14420–14421, 14424–14425 Importer of Controlled Substances Application: Sandy Hollow Hydroelectric Co., Inc., 14423–14424 Purisys, LLC, 14471–14472 Combined Filings, 14423, 14425–14426

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Effectiveness of Exempt Wholesale Generator Status: NOTICES Wolf Ridge Wind Energy, LLC; Blue Summit I Wind, Declaration Under the Public Readiness and Emergency LLC; Dickerson Power, LLC; et al., 14424 Preparedness Act for Medical Countermeasures Against Meetings; Sunshine Act, 14421–14423 COVID-19, 14462–14468 Surrender of Preliminary Permit: BM Energy Park, LLC, 14421 Health Resources and Services Administration NOTICES Federal Motor Carrier Safety Administration Agency Information Collection Activities; Proposals, NOTICES Submissions, and Approvals: Drug and Alcohol Clearinghouse Pre-Employment Full Voluntary Partner Surveys To Implement Executive Order Query; Exemption Applications: 12862 in the Health Resources and Services Controlled Substances and Alcohol Use and Testing: Administration, 14462 FirstGroup plc., 14516–14518 National Vaccine Injury Compensation Program: Qualification of Drivers; Exemption Applications: List of Petitions Received, 14459–14461 Vision, 14518–14521 Homeland Security Department Federal Railroad Administration See Coast Guard NOTICES See U.S. Citizenship and Immigration Services Petition for Waiver of Compliance, 14521–14523 Housing and Urban Development Department Food and Drug Administration RULES NOTICES Adjustment of Civil Monetary Penalty Amounts for 2021, Agency Information Collection Activities; Proposals, 14370–14374 Submissions, and Approvals: NOTICES Current Good Manufacturing Practice, Hazard Analysis, Section 8 Housing Assistance Payments Program: and Risk-Based Preventive Controls for Human and Fiscal Year 2021 Inflation Factors for Public Housing Animal Food, 14436–14440 Agency Renewal Funding, 14470–14471 Empirical Study of Promotional Implications of Proprietary Prescription Drug Names, 14440–14445 International Trade Administration Food and Cosmetic Export Certificate Application NOTICES Process, 14452–14454 Antidumping or Countervailing Duty Investigations, Orders, Request for Samples and Protocols, 14448–14450 or Reviews: Survey on the Occurrence of Foodborne Illness Risk Cast Iron Soil Pipe Fittings From the People’s Republic of Factors in Selected Retail and Foodservice Facility China, 14407 Types, 14433–14436 Pentafluoroethane (R–125) From the People’s Republic of Determination of Regulatory Review Period for Purposes of China, 14406–14407 Patent Extension: Hintermann Series H3 Total Ankle Replacement System, Justice Department 14445–14447 See Drug Enforcement Administration OCS Lung System, 14455–14456 Guidance: National Credit Union Administration Best Practices in Developing Proprietary Names for NOTICES Human Nonprescription Drug Products, 14454–14455 Meetings; Sunshine Act, 14472 Meetings: Potential Medication Error Risks With Investigational National Institutes of Health Drug Container Labels, 14457–14459 NOTICES Request for Comments: Meetings: Listing of Patent Information in the Orange Book, 14450– National Institute of Dental and Craniofacial Research, 14451 14468 Withdrawal of Approval of New Drug Applications: Bristol-Meyers Squibb Co., et al., 14447–14448 National Oceanic and Atmospheric Administration Withdrawal of Drug Products From Sale for Reasons Other RULES Than Safety or Effectiveness: Fisheries off West Coast States: NIPRIDE RTU (Sodium Nitroprusside), 10 Milligrams/50 Magnuson-Stevens Act Provisions; Pacific Coast Milliliters (0.2 Milligrams/Milliliters), 14451–14452 Groundfish Fishery; 2021–2022 Biennial Specifications and Management Measures; Foreign-Trade Zones Board Correction, 14379–14386 NOTICES PROPOSED RULES Proposed Production Activity: Fisheries Off West Coast States: Zoetis Services, LLC, Foreign-Trade Zone 59, Lincoln, Coastal Pelagic Species Fisheries; Amendment 18 to the NE, 14406 Coastal Pelagic Species Fishery Management Plan, 14401–14402 Health and Human Services Department NOTICES See Children and Families Administration Endangered and Threatened Species: See Food and Drug Administration Southern Oregon and Northern Coastal Spring- See Health Resources and Services Administration Run Chinook Salmon; 90-Day Finding on Petition To See National Institutes of Health List as Threatened or Endangered, 14407–14414

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National Transportation Safety Board Transportation Department NOTICES See Federal Aviation Administration Meetings; Sunshine Act, 14472 See Federal Motor Carrier Safety Administration See Federal Railroad Administration Nuclear Regulatory Commission NOTICES Exemption; Issuance: U.S. Citizenship and Immigration Services Exelon Generation Co., LLC; TMI–2 Solutions, LLC; NOTICES Three Mile Island Nuclear Station, Units 1 and 2, Agency Information Collection Activities; Proposals, 14472–14478 Submissions, and Approvals: Securities and Exchange Commission Application for Action on an Approved Application or NOTICES Petition, 14469–14470 Agency Information Collection Activities; Proposals, Interagency Alien Witness and Informant Record, 14468– Submissions, and Approvals, 14484, 14493–14494, 14469 14502–14503 Meetings; Sunshine Act, 14494 Veterans Affairs Department Self-Regulatory Organizations; Proposed Rule Changes: Cboe Exchange, Inc., 14494–14500 NOTICES Fixed Income Clearing, Corp., 14503–14506 Meetings: ICE Clear Europe, Ltd., 14478–14482 Advisory Committee on Homeless Veterans, 14523 Long-Term Stock Exchange, Inc., 14511–14513 Nasdaq ISE, LLC, 14482–14484 National Securities Clearing Corp., 14506–14508 The Depository Trust Co., 14500–14502 Reader Aids The Nasdaq Stock Market, LLC, 14484–14493, 14508– Consult the Reader Aids section at the end of this issue for 14511 phone numbers, online resources, finding aids, and notice of recently enacted public laws. Trade Representative, Office of To subscribe to the Federal Register Table of Contents NOTICES Modification of Section 301 Action: electronic mailing list, go to https://public.govdelivery.com/ Enforcement of United States World Trade Oorganization accounts/USGPOOFR/subscriber/new, enter your e-mail Rights in the Large Civil Aircraft Dispute, 14513– address, then follow the instructions to join, leave, or 14514 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.

12 CFR 1002...... 14363 14 CFR 39...... 14366 Proposed Rules: 25...... 14387 24 CFR 28...... 14370 30...... 14370 87...... 14370 180...... 14370 3282...... 14370 33 CFR Proposed Rules: 165...... 14389 34 CFR Ch. III ...... 14374 40 CFR Proposed Rules: 49...... 14392 52 (2 documents) ...... 14392, 14396 751...... 14398 47 CFR Proposed Rules: 73...... 14401 50 CFR 660...... 14379 Proposed Rules: 660...... 14401

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Rules and Regulations Federal Register Vol. 86, No. 49

Tuesday, March 16, 2021

This section of the FEDERAL REGISTER Regulation B prohibits a creditor from transactions.10 As such, financial contains regulatory documents having general discriminating against an applicant on a institutions subject to such laws were applicability and legal effect, most of which prohibited basis (including ‘‘sex’’ 4) required to comply with those are keyed to and codified in the Code of ‘‘regarding any aspect of a credit requirements prior to the issuance of the Federal Regulations, which is published under Bostock opinion. Many financial 50 titles pursuant to 44 U.S.C. 1510. transaction,’’ and from making ‘‘any oral or written statement to applicants or institutions recognize sexual orientation The Code of Federal Regulations is sold by prospective applicants that would and/or to be protected the Superintendent of Documents. discourage on a prohibited basis a classes under State laws 11 and may reasonable person from making or have determined to incorporate pursuing an application.’’ 5 practices that prohibit discrimination on BUREAU OF CONSUMER FINANCIAL these bases.12 PROTECTION On June 15, 2020, in Bostock v. Clayton County, , the Supreme 10 While not intended to be an all-inclusive list, 12 CFR Part 1002 Court ruled that the prohibition against the State statutes include Cal. Civ. Code secs. 51, sex discrimination in Title VII of the 51.5; Cal. Gov’t Code sec. 12955; Colo. Rev. Stat. Equal Credit Opportunity (Regulation (Title VII) sec. 24–34–501(3); Colo. Rev. Stat. sec. 5–3–210; Conn. Gen. Stat. secs. 46a–81e, 46a–81f, 46a–98; B); Discrimination on the Bases of encompasses sexual orientation Del. Code Ann. tit. 6, sec. 4604; D.C. Code sec. 2– Sexual Orientation and Gender Identity discrimination and gender identity 1402.21; Haw. Rev. Stat secs. 515–3, 515–5; 775 Ill. discrimination.6 The Court relied on Comp. Stat. sec. 5/1–102(A), 5/1–103(O), (O1), and AGENCY: Bureau of Consumer Financial three key findings to reach its decision: (Q), 5/4–102, 5/3–102, 5/4–103; Iowa Code secs. Protection. 216.8A, 216.10; Me. Rev. Stat. tit. 5, sec. 4553(5– (1) Sexual orientation discrimination C) and (9–C), 4595 to 4598, 4581 to 4583; Md. Code ACTION: Interpretive rule. and gender identity discrimination Ann, State Gov’t secs. 20–705, 20–707, 20–1103; necessarily involve consideration of sex; Mass. Gen. Laws ch. 151B, sec. 4(3B), (14); Minn. SUMMARY: The Bureau of Consumer Stat. secs. 363A.03 (Subd. 44), 363A.09(3), 363A.16 Financial Protection (Bureau) is issuing (2) Title VII’s language requires sex to be (Subds.1 and 3), 363A.17; N.H. Rev. Stat. Ann. sec. this interpretive rule to clarify that, with a ‘‘but for’’ cause of the injury, but need 354–A:10; N.J. Stat. Ann. sec. 10:5–12(i); N.M. Stat. respect to any aspect of a credit not be the only cause; and (3) Title VII’s Ann. sec. 28–1–7; N.Y. Civ. Rights Law sec. 40–c(2); language covers discrimination against N.Y. Exec. Law sec. 296–A; Or. Rev. Stat. secs. transaction, the prohibition against sex 174.100(7), 659A.421; R.I. Gen. Laws secs. 34–37– discrimination in the Equal Credit individuals, and not merely against 4(a) through (c), 34–37–4.3, 34–37–5.4; Va. Code Opportunity Act (ECOA) and Regulation groups.7 Ann. sec. 6.2–501(B)(1); 15.2–853; 15.2–965; Vt. Stat. Ann. tit. 8, sec. 10403; Vt. Stat. Ann. tit. 9, sec. B, which implements ECOA, In response to , 2362, 2410, 4503(a)(6); Wash. Rev. Code sec. encompasses sexual orientation ‘‘Preventing and Combatting 49.60.030, 49.60.040 (14), (26), and (27), 49.60.175, discrimination and gender identity Discrimination on the Basis of Gender 49.60.222; Wis. Stat. secs. 106.50, 224.77(1)(o). discrimination, including Identity or Sexual Orientation’’,8 which Also, since Bostock, the North Dakota Department of Labor and Human Rights has interpreted the discrimination based on actual or addresses Bostock, Jeanine M. Worden, North Dakota statutes against sex discrimination to perceived nonconformity with sex- Acting Assistant Secretary for Fair include sexual orientation and gender identity based or gender-based stereotypes and Housing & Equal Opportunity, released discrimination. N.D. Dep’t of Lab. and Hum. Rts. discrimination based on an applicant’s (NDDOLHR), NDDOLHR Now Accepting and a memorandum directing the Office of Investigating Charges of Discrimination Based on associations. Fair Housing and Equal Opportunity of Sexual Orientation and Gender Identity (June 18, DATES: This interpretive rule is effective the U.S. Department of Housing and 2020), https://www.nd.gov/labor/news/nddolhr- on March 16, 2021. Urban Development to take the actions now-accepting-and-investigating-charges- discrimination-based-sexual-orientation-and. There FOR FURTHER INFORMATION CONTACT: to administer and fully enforce the Fair are also a number of municipalities that include Pavy Bacon, Senior Counsel, Office of Housing Act to prohibit discrimination sexual orientation and/or gender identity in their Regulations at 202–435–7700. If you because of sexual orientation and credit discrimination ordinances. See, e.g., Austin 9 City Code sec. 5–1–1 et seq.; N.Y.C. Admin. Code require this document in an alternative gender identity. secs. 8–101, 8–107 et seq.; S.F. Police Code, sec. electronic format, please contact CFPB_ Before the issuance of the Bostock 3304(a) et seq. [email protected]. opinion, at least twenty states and the 11 See Consumer Bankers Ass’n (CBA), Comment Letter on Request for Information on the Equal SUPPLEMENTARY INFORMATION: District of Columbia prohibited Credit Opportunity Act and Regulation B (RFI), discrimination on the bases of sexual I. Background Document No. CFPB–2020–0026–0147 (Dec. 1, orientation and/or gender identity either 2020) (‘‘Many CBA members currently consider The Bureau is responsible for in all credit transactions or in certain sexual orientation and gender identity to be 1 protected classes under [S]tate laws, therefore, administering and enforcing ECOA (e.g., housing-related) credit potential post Bostock changes to how the Bureau 2 and its implementing Regulation B. interprets ECOA’s prohibition on discrimination on ECOA makes it ‘‘unlawful for any 4 12 CFR 1002.2(z). the basis of sex would likely align with, and would not significantly alter, practices that comply with creditor to discriminate against any 5 12 CFR 1002.4(a)–(b). state laws.’’). applicant, with respect to any aspect of 6 Bostock v. Clayton Cty., Georgia, 140 S. Ct. 1731, 12 See, e.g., Off. of the Comptroller of the 207 L. Ed. 2d 218 (2020). a credit transaction,’’ on several Currency, Interpretive Letter #998 (Mar. 9, 2004), 7 enumerated bases, including ‘‘on the Id. https://www.occ.gov/topics/charters-and-licensing/ basis of . . . sex . . . ’’ 3 Likewise, 8 86 FR 7023 (Jan. 25, 2021). interpretations-and-actions/2004/int998.pdf 9 U.S. Dep’t. of Hous. and Urban Dev., (‘‘[W]hat would generally be understood to be an Memorandum, Implementation of Executive Order ‘anti-discrimination’ law . . . [e.]g., laws that 1 15 U.S.C. 1691–1691f. 13988 on the Enforcement of the Fair Housing Act prohibit lenders from discriminating on the basis of 2 12 CFR part 1002. (Feb. 11, 2021), https://www.hud.gov/sites/dfiles/ race, religion, ethnicity, gender, sexual orientation, 3 15 U.S.C. 1691(a)(1). PA/documents/HUD_Memo_EO13988.pdf. Continued

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The Bureau has previously indicated or gender identity. Many comments to It is well established that ECOA and that legal developments would lead to the Bureau’s recent Request for Title VII are generally interpreted prohibitions against sex discrimination Information on the Equal Credit consistently.22 Like Title VII,23 ECOA being interpreted to afford broad Opportunity Act and Regulation B prohibits sex discrimination (among protection against discrimination on the (RFI) 17 from a variety of stakeholders, other bases) and does not require that bases of sexual orientation and gender including consumer and civil rights sex (or other protected characteristics) identity. In 2016, in response to an advocates, a local government official, be the sole or primary reason for an inquiry from Services & Advocacy for an academic institution, and industry action to be discriminatory.24 Like Title GLBT Elders (SAGE), the Bureau sent a representatives, reiterated this request VII,25 ECOA applies to sex letter addressing coverage of sex for regulatory clarification.18 The discrimination against individuals, not discrimination involving sexual Bureau is issuing this interpretive rule just to situations where all men or all orientation and gender identity under to address any regulatory uncertainty women (or any other group of people ECOA.13 The letter to SAGE concluded that may still exist under ECOA and with a common protected characteristic) that ‘‘the current state of the law Regulation B as to the term ‘‘sex’’ so as are discriminated against supports arguments that the prohibition to ensure the fair, equitable, and of sex discrimination in ECOA and nondiscriminatory access to credit for 22 See, e.g., Equal Credit Opportunity Act Regulation B affords broad protection both individuals and communities and Amendments of 1976, Public Law 94–239, 114 Stat. 246 (1976); S. Rep. 94–589, at 4–5 (1976), reprinted against credit discrimination on the to ensure that consumers are protected in 1976 U.S.C.C.A.N. 403. (‘‘judicial constructions bases of gender identity and sexual from discrimination.19 This interpretive of anti-discrimination legislation in the orientation, including but not limited to rule serves a stated purpose of employment field . . . are intended to serve as discrimination based on actual or Regulation B, which is to ‘‘promote the guides in the application of this [Equal Credit Opportunity] Act’’); Mercado-Garcia v. Ponce Fed. perceived nonconformity with sex- availability of credit to all creditworthy Bank, 979 F.2d 890, 893 (1st Cir. 1992) (applying based or gender-based stereotypes as applicants without regard to . . . sex Title VII standards in interpreting ECOA); Bhandari well as discrimination based on one’s ... ’’20 v. First Nat’l Bank of Commerce, 808 F.2d 1082, associations.’’ 14 Further, the letter to 1100 (5th Cir. 1987) (same); Rosa v. Park W. Bank II. Discussion & Tr. Co., 214 F.3d 213, 215 (1st Cir. 2000) SAGE stated that the Bureau ‘‘will (‘‘look[ing] to Title VII case law’’ and reversing the continue to monitor these legal The Bureau interprets the ECOA and dismissal of a sex discrimination claim filed by a developments closely as we strive to Regulation B prohibitions against person who alleged being denied a loan ensure that our interpretation and discrimination on the basis of ‘‘sex’’ to application for failing to appear in clothing consistent with the sex reflected on their application of laws and rules under our include discrimination based on sexual identification cards). See also Bostock, 140 S. Ct. at jurisdiction, including ECOA and orientation and/or gender identity. The 1778 (Alito, S., dissenting) (expressing the view that Regulation B, appropriately reflect the Bureau’s interpretation is consistent the decision ‘‘is virtually certain to have far- evolving precedents interpreting sexual with the Court’s conclusion in Bostock reaching consequences’’ including, specifically, 15 with regard to ECOA). discrimination law.’’ The Bureau also regarding sex discrimination under Title 23 Bostock, 140 S. Ct. at 1734 (holding that under 21 incorporated its views regarding sex VII. Title VII, ‘‘the plaintiff’s sex need not be the sole discrimination under ECOA and or primary cause of the employer’s adverse action’’). Regulation B into its ECOA brochure 17 85 FR 46600 (Aug. 3, 2020). 24 See Official Staff Commentary, 12 CFR part and AskCFPB materials.16 18 See, e.g., Nat’l Fair Hous. All., Comment Letter 1002, supp. I, ¶ 4(a)–1) (‘‘Disparate treatment on a After the Supreme Court issued the on RFI, Document No. CFPB–2020–0026–0137 (Dec. prohibited basis is illegal whether or not it results 1, 2020); City of Houston, City Controller, Comment from a conscious intent to discriminate.’’); Saldana Bostock opinion, diverse stakeholders Letter on RFI, Document No. CFPB–2020–0026– v. Citibank, Fed. Sav. Bank, No. 93 C 4164, 1996 asked the Bureau to clarify that ECOA’s 0120 (Dec. 1, 2020); Steven Trovarelli, Comment WL 332451, at *2 (N.D. Ill. June 13, 1996) (‘‘To and Regulation B’s prohibition of ‘‘sex’’ Letter on RFI, CFPB–2020–0026–0051 (Oct. 1, establish a case of lending discrimination under the discrimination includes discrimination 2020); Anonymous, Comment Letter on RFI, [Fair Housing Act] or the ECOA, [plaintiff] does not Document No. CFPB–2020–0026–0064– (Nov. 3, need to prove an actual intent to discriminate on on the bases of sexual orientation and/ 2020); Consortium for Citizens with Disabilities Fin. the part of [defendant], but she must show that race Sec. & Poverty Task Force, Comment Letter on RFI, played some role in [defendant’s] decision.’’). disability, or the like . . . would not be Document No. CFPB–2020–0026–0104– (Dec. 1, Moreover, the 1994 Interagency Policy Statement on preempted.’’) (emphasis in original); Nat’l Cmty. 2020); Nat’l Women’s Law Ctr., Comment Letter on Discrimination in Lending (Policy Statement) Reinvestment Coal., Comment Letter on RFI, RFI, Document No. CFPB–2020–0026–0112–A1 provides an illustration of disparate treatment Document No. CFPB–2020–0026–0123 (Dec. 1, (Dec. 1, 2020); Cmty. Dev. Bankers Ass’n (CDBA), where the applicants’ minority status was not the 2020) (noting that ‘‘defense attorneys have already Comment Letter on RFI, Document No. CFPB– sole or primary reason for the loan denial since adverse credit information was also a factor in the informed the mortgage industry that as more State 2020–0026–0113 (Dec. 1, 2020); Mortg. Bankers decision. The illustration states that a nonminority laws incorporate this robust definition of sex, they Ass’n, Comment Letter on RFI, Document No. couple applied for an automobile loan. The lender should incorporate it into their policies and CFPB–2020–0026–0115 (Dec. 1, 2020); Nat’l Cmty. found adverse information in the couple’s credit procedures’’) (citation omitted). Reinvestment Coal., Comment Letter on RFI, report. The lender discussed the credit report with 13 See Letter from Bureau of Consumer Fin. Prot., Document No. CFPB–2020–0026–0123 (Dec. 1, them and determined that the adverse information to Serv. & Advocacy for GLBT Elders (SAGE), (Aug. 2020); LendingClub, Comment Letter on RFI, (a judgment against the couple) was incorrect since 30, 2016), https://files.consumerfinance.gov/f/ Document No. CFPB–2020–0026–0126 (Dec. 2, the judgment had been vacated. The nonminority documents/cfpb_sage-response-letter_2021-02.pdf. 2020); Nat’l Consumer Law Ctr., Comment Letter on couple was granted their loan. A minority couple 14 RFI, Document No. CFPB–2020–0026–0129–A1 Id. at 7. applied for a similar loan with the same lender. 15 Id. (Dec. 2, 2020); The Williams Institute, Comment Upon discovering adverse information in the 16 See Bureau of Consumer Fin. Prot., Helping Letter on RFI, Document No. CFPB–2020–0026– minority couple’s credit report, the lender denied consumers understand credit discrimination (Mar. 0132 (Dec. 2, 2020); Nat’l Disability Rts. Network, the loan application on the basis of the adverse 2017), https://files.consumerfinance.gov/f/ Comment Letter on RFI, Document No. CFPB– information without giving the couple an documents/201703_cfpb_handout_ECOA_helping_ 2020–0026–0139 (Dec. 2, 2020); Serv. & Advocacy opportunity to discuss the report. 59 FR 18266, consumers.pdf; Bureau of Consumer Fin. Prot., for GLBT Elders (SAGE), Comment Letter on RFI, 18268 (Apr. 15, 1994); Bureau of Consumer Fin. What protections do I have against credit Document No. CFPB–2020–0026–0141 (Dec. 2, Prot., Bulletin 2012–04 (Fair Lending) (Apr. 18, discrimination?, https://www.consumerfinance.gov/ 2020); Ctr. for Am. Progress, Comment Letter on 2012), https://files.consumerfinance.gov/f/201404_ fair-lending/. (Both state: ‘‘Currently, the law RFI, Document No. CFPB–2020–0026–0144 (Dec. 2, cfpb_bulletin_lending_discrimination.pdf (the supports arguments that the prohibition against sex 2020); Consumer Bankers Ass’n, Comment Letter on Bureau expressed its concurrence with the Policy discrimination also affords broad protection from RFI, Document No. CFPB–2020–0026–0147 (Dec. 2, Statement). discrimination based on a consumer’s gender 2020). 25 Bostock, 140 S. Ct. at 1734 (finding that ‘‘an identity and sexual orientation.’’). The Bureau will 19 12 U.S.C. 5493(c)(2)(A), 5511(b)(2). employer cannot escape liability [under Title VII] update these and other materials to reflect this 20 12 CFR 1002.1(b). by demonstrating that it treats males and females interpretive rule. 21 See Bostock, 140 S. Ct. 1731. comparably as groups’’).

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categorically.26 Indeed, Regulation B a male applicant on the basis that he is categorically.35 Further, ECOA and clarifies that ECOA prohibits attracted to men, the creditor Regulation B, like Title VII, work to discrimination based not only on the discriminates against him for traits or protect individuals of all sexes from characteristics of an applicant but also actions it tolerates in female applicants; discrimination, and do so equally.36 For based on the characteristics of a person further, this discrimination is example, a creditor who rejects an with whom an applicant associates.27 motivated, at least partly, by the application from a woman because the The Bureau believes that even though applicant ‘‘failing to fulfill traditional loan officer regards her as insufficiently the term ‘‘sex’’ is not defined in ECOA sex stereotypes.’’ 29 Or, if a creditor feminine, and also rejects an application or Regulation B, the prohibitions against declines the loan forbearance from a man because the loan officer discrimination on the basis of ‘‘sex’’ application of a transgender person who regards him as being insufficiently under ECOA and Regulation B are was identified as male at birth but who masculine, may treat men and women correctly interpreted to include now identifies as female, but approves as groups more or less equally. But in discrimination based on sexual the application of an otherwise both scenarios, the creditor has orientation and/or gender identity. As similarly-situated applicant who was discriminated against an applicant in explained below and consistent with the identified as female at birth and now violation of ECOA and Regulation B by Court’s analysis in the Bostock opinion, continues to identify as female, the rejecting an individual applicant in part this conclusion can be based on ‘‘no creditor discriminates against a person because of sex. Instead of avoiding more than the straightforward identified as male at birth for traits or ECOA exposure, this creditor ‘‘doubles application of legal terms with plain actions that it tolerates in an applicant it.’’ 37 It is no defense for a creditor to and settled meanings.’’ 28 But, even if it identified as female at birth. In these argue that it is equally happy to reject were not so straightforward, the Bureau examples, the individual applicant’s male and female applicants who are gay would still reach the same conclusion ‘‘sex plays an unmistakable and or transgender because each instance of based on its expertise in interpreting impermissible role’’ 30 in the credit discriminating against an individual ECOA and Regulation B. In sum, the decisions and thus constitutes applicant because of that individual’s Bureau finds that under ECOA and discrimination on the basis of sex in sex is an independent violation of Regulation B: (1) Sexual orientation violation of ECOA and Regulation B. ECOA and Regulation B.38 discrimination and gender identity The Bureau’s interpretation is consistent Last, the Bureau interprets the ECOA discrimination necessarily involve with the Supreme Court’s conclusion in and Regulation B prohibition against consideration of sex; (2) an applicant’s Bostock that ‘‘it is impossible to discrimination on the basis of ‘‘sex’’ to sex must be a ‘‘but for’’ cause of the discriminate against a person for being also include discrimination motivated injury, but need not be the only cause; homosexual or transgender without by perceived nonconformity with sex- and (3) discrimination against discriminating against that individual based or gender-based stereotypes, individuals, and not merely against based on sex.’’ 31 including those related to gender groups, is covered. The Bureau also Second, under ECOA and Regulation identity and/or sexual orientation, as clarifies that ECOA’s and Regulation B’s B, as under Title VII, sex does not have well as discrimination based on an prohibition against sex discrimination to be the sole or primary reason for an applicant’s associations. An example of encompasses discrimination motivated action to be discriminatory.32 For discriminatory sex-based or gender- by perceived nonconformity with sex- example, when a creditor rejects an based stereotyping occurs if a small based or gender-based stereotypes, as applicant on the basis of their being gay business lender discourages a small well as discrimination based on an or transgender, two causal factors may business owner appearing at its office applicant’s associations. be in play—both the individual’s sex from applying for a business loan and First, under ECOA and Regulation B, and something else (the sex to which tells the prospective applicant to go as under Title VII, sexual orientation the individual is attracted or with which home and change because, in the view discrimination and gender identity the individual identifies).33 Under of the creditor, the small business discrimination necessarily involve ECOA and Regulation B, if a creditor customer’s attire does not accord with consideration of sex. For example, if a would not have rejected a credit the customer’s gender.39 The Bureau’s creditor declines the loan application of applicant or discouraged a prospective interpretation regarding discriminatory applicant but for that individual’s sex, stereotyping is consistent with multiple 26 While Title VII prohibits discrimination against the causation standards are met, and court decisions 40 and with the Court’s ‘‘any individual,’’ 42 U.S.C. 2000e–2(a)(1), and liability may attach.34 Bostock decision.41 The Bureau’s ECOA prohibits discrimination against ‘‘any Third, ECOA and Regulation B, like applicant,’’ 15 U.S.C. 1691(a), both statutes refer to Title VII, apply to sex discrimination 35 See Bostock, 140 S. Ct. at 1740–41; see also a singular person or applicant rather than a group. Rosa, 214 F.3d at 215 (finding a potential ECOA ECOA defines an ‘‘applicant’’ as ‘‘any person who against individuals, not just to claim where the plaintiff ‘‘did not receive the loan applies to a creditor directly for an extension, situations where all men or all women application because he was a man, whereas a renewal, or continuation of credit or applies to a are discriminated against similarly situated woman would have received the creditor indirectly by use of an existing credit plan loan application’’). for an amount exceeding a previously established 29 36 credit limit.’’ 15 U.S.C. 1691a(b). Regulation B Id. at 1742. See Bostock, 140 S. Ct. at 1741. defines an ‘‘applicant’’ as ‘‘any person who requests 30 Id. at 1741–42. 37 See id. at 1741. or who has received an extension of credit from a 31 Id. at 1741. Notwithstanding differences in the 38 See id. at 1742–43. creditor, and includes any person who is or may ways that Title VII and ECOA phrase their 39 See, e.g., Rosa, 214 F.3d at 214–15. become contractually liable regarding an extension prohibition against sex discrimination, the Bureau 40 See EEOC v. Boh Bros. Constr. Co., 731 F.3d of credit.’’ 12 CFR 1002.2(e). interprets ECOA and Regulation B to incorporate 444, 457–58 (5th Cir. 2013) (en banc); Glenn v. 27 12 CFR part 1002, supp. I, ¶ 2(z)–1 (providing the Bostock principles and reasoning with respect Brumby, 663 F.3d 1312, 1314, 1320–21 (11th Cir. that ‘‘prohibited basis refers not only to to the recognition of sexual orientation 2011); Barnes v. City of , 401 F.3d 729, characteristics—the race, color, religion, national discrimination and gender identity discrimination 735–37 (6th Cir. 2005); Nichols v. Azteca Rest. origin, sex, marital status, or age—of an applicant as sex discrimination under ECOA and Regulation Enterprises, Inc., 256 F.3d 864, 870, 874–75 (9th (or officers of an applicant in the case of a B. Cir. 2001); Rosa, 214 F.3d at 215. corporation) but also to the characteristics of 32 See id. at 1744; 59 FR 18266, 18268 (Apr. 15, 41 See Bostock, 140 S. Ct. at 1742–43 (stating that individuals with whom an applicant is affiliated or 1994). an employer who fires employees ‘‘for failing to with whom the applicant associates’’). 33 See id. at 1742. fulfill traditional sex stereotypes doubles rather 28 Bostock, 140 S. Ct. at 1743. 34 See id. at 1742; see also Rosa, 214 F.3d at 215. Continued

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interpretation regarding associational discrimination on the basis of ‘‘sex’’ Management and Budget under the discrimination is similarly consistent includes discrimination or Paperwork Reduction Act.50 with the Court’s reasoning in Bostock discouragement based on sexual Pursuant to the Congressional Review regarding how discrimination based on orientation and/or gender identity, Act,51 the Bureau will submit a report the sex, including sexual orientation including but not limited to containing this interpretive rule and and/or gender identity, of the persons discrimination based on actual or other required information to the U.S. with whom the individual associates is perceived nonconformity with sex- Senate, the U.S. House of prohibited under Title VII.42 A creditor based or gender-based stereotypes and Representatives, and the Comptroller engages in such associational discrimination based on an applicant’s General of the United States prior to the discrimination if it, for example, associations. rule’s published effective date. The requires a person applying for credit III. Legal Authority Office of Information and Regulatory who is married to a person of the same- Affairs has designated this interpretive sex to provide different documentation This interpretive rule is issued under rule as not a ‘‘major rule’’ as defined by of the marriage than a person applying the Bureau’s authority to interpret the 5 U.S.C. 804(2). ECOA and Regulation B, including for credit who is married to a person of Dated: March 5, 2021. the opposite sex. The Bureau’s under section 1022(b)(1) of the Dodd- David Uejio, interpretation is consistent with the Frank Wall Street Reform and Consumer principle, applied by Federal agencies Protection Act, which authorized Acting Director, Bureau of Consumer for decades, that credit discrimination guidance as may be necessary or Financial Protection. on a prohibited basis includes appropriate to enable the Bureau to [FR Doc. 2021–05233 Filed 3–15–21; 8:45 am] discrimination against an applicant administer and carry out the purposes BILLING CODE 4810–AM–P because of the protected characteristics and objectives of Federal consumer of individuals with whom they are financial laws.45 affiliated or associated (e.g., spouses, By operation of the ECOA section DEPARTMENT OF TRANSPORTATION domestic partners, dates, friends, 706(e), no provision of ECOA sections coworkers).43 Moreover, the Bureau has 701(a), 704(b), 706(a), or 706(b) Federal Aviation Administration previously established that a creditor imposing any liability applies to any act may not discriminate against an done or omitted in good faith in 14 CFR Part 39 applicant because of that person’s conformity with this interpretive rule, [Docket No. FAA–2021–0144; Project personal or business dealings with notwithstanding that after such act or Identifier MCAI–2021–00255–R; Amendment members of a protected class, because of omission has occurred, the rule is 39–21473; AD 2021–06–06] amended, rescinded, or determined by the protected class of any persons RIN 2120–AA64 associated with the extension of credit, judicial or other authority to be invalid 46 or because of the protected class of other for any reason. Airworthiness Directives; Bell Textron residents in the neighborhood where the IV. Effective Date Canada Limited Helicopters property offered as collateral is located.44 Because this rule is solely AGENCY: Federal Aviation For these reasons, the ECOA and interpretive, it is not subject to the 30- Administration (FAA), DOT. Regulation B prohibition against day delayed effective date for ACTION: Final rule; request for substantive rules under section 553(d) 47 comments. than eliminates Title VII liability, an employer who of the Administrative Procedure Act. fires [employees] for being gay or transgender does Therefore, this rule is effective on SUMMARY: The FAA is superseding the same’’). March 16, 2021, the same date that it is Emergency Airworthiness Directive 42 See id. at 1748 (‘‘So, for example, when it published in the Federal Register. comes to homosexual employees, male sex and (AD) 2021–05–52 which applied to attraction to men are but-for factors that can V. Regulatory Matters certain Bell Textron Canada Limited combine to get them fired. The fact that female sex (Bell) Model 505 helicopters. Emergency and attraction to women can also get an employee As an interpretive rule, this rule is AD 2021–05–52 required a one-time fired does no more than show the same outcome exempt from the notice-and-comment can be achieved through the combination of visual inspection of the pilot collective different factors. In either case, though, sex plays rulemaking requirements of the stick and grip assembly (pilot collective 48 an essential but-for role.’’). Administrative Procedure Act. stick), a fluorescent penetrant 43 See Equal Credit Opportunity; Revision of Because no notice of proposed inspection (FPI) if no crack was found Regulation B; Official Staff Commentary, 50 FR rulemaking is required, the Regulatory 48018, 48049 (Nov. 20, 1985) (providing that during the visual inspection, and discrimination on a ‘‘prohibited basis refers not Flexibility Act does not require an depending on the inspection results, only to characteristics—the race, color, religion, initial or final regulatory flexibility removing the pilot collective stick from 49 national origin, sex, marital status, or age—of an analysis. The Bureau also has service and reporting certain applicant (or officers of an applicant in the case of determined that this interpretive rule a corporation) but also to the characteristics of information to Bell. Emergency AD individuals with whom an applicant is affiliated or does not impose any new or revise any 2021–05–52 also prohibited installing with whom the applicant associates,’’ or because of existing recordkeeping, reporting, or any pilot collective stick on any the characteristics of people with whom an disclosure requirements on covered applicant has ‘‘personal or business dealings’’); 59 helicopter unless the inspections had FR 18266, 18268 (Apr. 15, 1994) (stating that ‘‘A entities or members of the public that been accomplished. This AD removes lender may not discriminate on a prohibited basis would be collections of information the visual inspection of the pilot because of the characteristics of: [a] person requiring approval by the Office of collective stick, requires repetitive FPIs associated with a credit applicant (for example, a co-applicant, spouse, business partner, or live-in- of the pilot collective stick, and requires 45 12 U.S.C. 5512(b)(1). The relevant provisions of aide); or [t]he present or prospective occupants of revising the existing Rotorcraft Flight the ECOA and Regulation B form part of Federal the area where property to be financed is located.’’); Manual (RFM) for your helicopter. This 76 FR 79442, 79473 (Dec. 21, 2011); 81 FR 25323, consumer financial law. 12 U.S.C. 5481(12)(D), (14). 46 25325 (Apr. 28, 2016); Official Staff Commentary, 15 U.S.C. 1691(e). AD retains the reporting requirement 12 CFR part 1002, supp. I, ¶ 2(z)–1). 47 75 U.S.C. 553(d). 44 Official Staff Commentary, 12 CFR part 1002, 48 5 U.S.C. 553(b). 50 44 U.S.C. 3501–3521. supp. I, ¶ 2(z)–1). 49 5 U.S.C. 603(a), 604(a). 51 5 U.S.C. 801 et seq.

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and expands the prohibition. This AD Washington, DC 20024; telephone (202) service information. The service was prompted by the determination that 267–9167; email [email protected]. information was first revised to remove visual inspections do not adequately SUPPLEMENTARY INFORMATION: the procedures for a visual inspection detect a crack and additional findings and instead specify recurring FPIs, and that a crack may occur sooner than Background Transport Canada superseded Canadian previously expected. The FAA is issuing On February 22, 2021, the FAA issued AD CF–2021–05 accordingly with this AD to address the unsafe condition Emergency AD 2021–05–52 (Emergency Emergency AD CF–2021–05R1, dated on these products. AD 2021–05–52), which was made February 26, 2021 (Canadian AD CF– DATES: This AD becomes effective immediately effective to all known U.S. 2021–05R1). Canadian AD CF–2021– March 31, 2021. owners and operators of Bell Model 505 05R1 advised that examination of a pilot The Director of the Federal Register helicopters, serial numbers 65011 and collective stick and another cracked approved the incorporation by reference subsequent. Emergency AD 2021–05–52 pilot collective stick by Bell revealed of certain documents listed in this AD required, before further flight, removing fatigue cracking. Based on these as of March 31, 2021. the pilot collective stick from the findings, Bell determined that a visual The FAA must receive comments on jackshaft assembly, cleaning it, and then inspection is not adequate for detecting this AD by April 30, 2021. visually inspecting the complete smaller cracks. Accordingly, Canadian circumference of certain areas for a ADDRESSES: You may send comments, AD CF–2021–05R1 required an initial crack. If the visual inspection did not using the procedures found in 14 CFR FPI for cracks before further flight and reveal a crack, Emergency AD 2021–05– 11.43 and 11.45, by any of the following then at intervals not to exceed 25 hours 52 required performing an FPI for a methods: time-in-service (TIS). Canadian AD CF– crack. Removing from service any • Federal eRulemaking Portal: Go to 2021–05R1 also contained a ferry flight cracked pilot collective stick was https://www.regulations.gov. Follow the provision that specifies that ferry flights required before further flight, and if a instructions for submitting comments. are permitted to a maintenance base to crack was discovered, reporting certain • Fax: (202) 493–2251. carry out the FPI, provided that the information to Bell was required within • Mail: U.S. Department of helicopter is flown from the copilot seat 10 days. only. Transport Canada considered Transportation, Docket Operations, M– Emergency AD 2021–05–52 was 30, West Building Ground Floor, Room Canadian AD CF–2021–05R1 an interim prompted by Canadian Emergency AD action and stated that further AD action W12–140, 1200 Avenue SE, CF–2021–05, dated February 21, 2021 Washington, DC 20590. may follow. • (Canadian AD CF–2021–05), issued by Hand Delivery: Deliver to Mail Transport Canada, which is the aviation Bell then again revised its service address above between 9 a.m. and 5 authority for Canada, to correct an information to specify inserting a p.m., Monday through Friday, except unsafe condition for Bell Model 505 temporary revision (TR) into the RFM Federal holidays. helicopters, serial numbers 65011 and that prohibits single pilot operations For service information identified in subsequent. Transport Canada advised from the right crew seat. Transport this final rule, contact Bell Textron of a report that a pilot collective stick Canada again superseded its AD Canada Limited, 12,800 Rue de l’Avenir, cracked above the cabin floor at the accordingly with Emergency AD CF– Mirabel, Quebec J7J1R4; telephone (450) junction with the collective jackshaft. 2021–05R2, dated March 4, 2021 437–2862 or (800) 363–8023; fax (450) This finding occurred prior to engine (Canadian AD CF–2021–05R2). 433–0272; or at https:// start during the pilot pre-flight check of Canadian AD CF–2021–05R2 specifies www.bellcustomer.com. You may view flight controls for travel. The exact that subsequent to the issuance of this service information at the FAA, cause of the crack was still under Canadian AD CF–2021–05R1, additional Office of the Regional Counsel, investigation, and Transport Canada FPI findings showed that cracking of the Southwest Region, 10101 Hillwood advised that the unsafe condition, if not pilot collective stick could occur at very Pkwy., Room 6N–321, Fort Worth, TX addressed, could result in failure of the low flight hours. As a result, Bell 76177. For information on the pilot collective stick and subsequent published revised service information to availability of this material at the FAA, loss of control of the helicopter. introduce TRs to the RFMs to prohibit call (817) 222–5110. It is also available Accordingly, Canadian AD CF–2021– single pilot operations from the right at https://www.regulations.gov by 05 required a one-time visual inspection crew seat. Transport Canada considers searching for and locating Docket No. and as applicable, an FPI of the pilot Canadian AD CF–2021–05R2 an interim FAA–2021–0144. collective stick to detect cracking. If the action as well and states that further AD action may follow to mandate further Examining the AD Docket pilot collective stick was found to be unserviceable, Canadian AD CF–2021– corrective actions to modify the pilot You may examine the AD docket at 05 required replacing the collective collective stick to prevent cracking and https://www.regulations.gov by stick with a serviceable part prior to subsequent failure. searching for and locating Docket No. further flight. Transport Canada advised FAA’s Determination FAA–2021–0144; or in person at Docket that a serviceable collective stick is a Operations between 9 a.m. and 5 p.m., new collective stick or a collective stick These helicopters have been approved Monday through Friday, except Federal with no crack found during the visual by the aviation authority of Canada and holidays. The AD docket contains this inspection or FPI required by its AD. are approved for operation in the United final rule, the Transport Canada AD, any Transport Canada considered Canadian States. Pursuant to the FAA’s bilateral comments received, and other AD CF–2021–05 an interim action and agreement with Canada, Transport information. The street address for stated that further AD action may Canada, its technical representative, has Docket Operations is listed above. follow. notified the FAA of the unsafe condition FOR FURTHER INFORMATION CONTACT: Hal described in its AD. The FAA is issuing Jensen, Aerospace Engineer, Operational Actions Since Emergency AD 2021–05– this AD after evaluating all known Safety Branch, Compliance & 52 was Issued relevant information and determining Airworthiness Division, FAA National Since the FAA issued Emergency AD that the unsafe condition described Headquarters, 950 L’Enfant Plaza N SW, 2021–05–52, Bell has twice revised its previously is likely to exist or develop

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on other helicopters of the same type AD Requirements the FAA might consider further design. rulemaking. This AD requires, before further flight, Related Service Information Under 1 revising Section 1, the Limitations Justification for Immediate Adoption CFR Part 51 section of the existing RFM for your and Determination of the Effective Date The FAA reviewed Bell Alert Service helicopter to prohibit single pilot Section 553(b)(3)(B) of the Bulletin 505–21–20, Revision B, dated operations from the right crew seat, Administrative Procedure Act (APA) (5 March 3, 2021 (ASB 505–21–20 Rev B). require the pilot in command to occupy U.S.C. 551 et seq.) authorizes agencies ASB 505–21–20 Rev B provides the left crew seat for dual pilot to dispense with notice and comment instructions for an initial and recurring operations, and depending on procedures for rules when the agency, FPIs for cracks in the pilot collective configuration, prohibiting the use of for ‘‘good cause,’’ finds that those stick and grip assembly part number SPLIT–COM mode. This AD also procedures are ‘‘impracticable, M207–20M478–041/–043/–047 on Bell requires, before further flight and unnecessary, or contrary to the public Model 505 helicopters, serial numbers thereafter at intervals not to exceed 25 interest.’’ Under this section, an agency, 65011 and subsequent. ASB 505–21–20 hours TIS, removing the pilot collective upon finding good cause, may issue a Rev B also specifies inserting TRs into stick from the jackshaft assembly, final rule without providing notice and the RFMs that prohibit single pilot cleaning it as specified in ASB 505–21– seeking comment prior to issuance. operations from the right crew seat until 20 Rev B, and performing an FPI for a Further, section 553(d) of the APA further notice. Finally, ASB 505–21–20 crack as specified in ASB 505–21–20 authorizes agencies to make rules Rev B specifies that if the right crew seat Rev B. Removing from service any effective in less than thirty days, upon pilot collective stick assembly was cracked pilot collective stick is required a finding of good cause. previously confirmed serviceable before further flight. In addition, this An unsafe condition exists that following an FPI in accordance with AD requires, within 10 days after the requires the immediate adoption of this Bell Alert Service Bulletin 505–21–20, discovery of any crack, reporting certain AD without providing an opportunity Revision A, dated February 26, 2021 information to Bell. This AD also for public comments prior to adoption. (ASB 505–21–20 Rev A), which is not prohibits installing any pilot collective The FAA has found that the risk to the incorporated by reference in this AD, stick and grip assembly on any flying public justifies foregoing notice then the 25 flight hour recurring FPI of helicopter unless it has successfully and comment prior to adoption of this the right crew seat pilot collective stick passed the FPI inspection requirements rule because certain requirements must assembly is no longer required provided of this AD. Lastly, this AD prohibits be accomplished before further flight. that the helicopter is only operated relief under any Master Minimum Accordingly, notice and opportunity for single pilot in command (PIC) from the Equipment List or Minimum Equipment prior public comment are impracticable left crew seat. If conducting dual pilot List for the Audio Panel when the and contrary to the public interest operations, ASB 505–21–20 Rev B aircraft is operated with a single pilot. pursuant to 5 U.S.C. 553(b)(3)(B). specifies a 25 flight hour recurring FPI Differences Between This AD and the In addition, the FAA finds that good of the right crew seat pilot collective Transport Canada cause exists pursuant to 5 U.S.C. 553(d) stick assembly. for making this amendment effective in The FAA also reviewed Bell 505 RFM This AD prohibits relief under any less than 30 days, for the same reasons TR for Pilot Collective (ASB 505–21– Master Minimum Equipment List or the FAA found good cause to forego 20), BHT–505–FM–1, Temporary Minimum Equipment List for the Audio notice and comment. Revision (TR–6) (BHT–505–FM–1, TR– Panel when the aircraft is operated with Comments Invited 6) and Bell 505 RFM TR for Pilot a single pilot, whereas Canadian AD Collective (ASB 505–21–20), BHT–505– CF–2021–05R2 does not. Canadian AD The FAA invites you to send any FM–2, Temporary Revision (TR–1), each CF–2021–05R2 requires the repetitive written data, views, or arguments about dated March 3, 2021. These TRs specify FPI if the aircraft is not flown solely this final rule. Send your comments to changes to Section 1 of the RFM from the left crew seat whereas this AD an address listed under ADDRESSES. Limitations Section that the minimum requires FPI regardless. Include ‘‘Docket No. FAA–2021–0144; flight crew consists of one pilot that Interim Action Project Identifier MCAI–2021–00255–R’’ shall operate from the left crew seat and at the beginning of your comments. The that dual operation is approved provide The FAA considers this AD to be an most helpful comments reference a that the PIC occupies the left crew seat. interim action and acknowledges that specific portion of the final rule, explain BHT–505–FM–1, TR–6 also prohibits the requirement to revise the existing the reason for any recommended use of SPLIT–COM mode. RFM for your helicopter to require the change, and include supporting data. This service information is reasonably pilot in command to occupy the left The FAA will consider all comments available because the interested parties crew seat, and, depending on received by the closing date and may have access to it through their normal configuration, prohibit the use of amend this final rule because of those course of business or by the means SPLIT–COM mode may impact seat- comments. identified in the ADDRESSES section. dependent training for some helicopters Except for Confidential Business operating under Part 135. However, the Information (CBI) as described in the Other Related Service Information unsafe condition requires the FAA to following paragraph, and other The FAA reviewed Bell ASB 505–21– mandate these requirements for information as described in 14 CFR 20, dated February 20, 2021 (ASB 505– continued operational safety. The 11.35, the FAA will post all comments 21–20) and ASB 505–21–20 Rev A. ASB inspection reports that are required by received, without change, to https:// 505–21–20 specifies a one-time this AD will enable the FAA to obtain www.regulations.gov, including any inspection for cracks of the pilot better insight into the cause of the personal information you provide. The collective stick and grip assembly. ASB cracking, and eventually develop final agency will also post a report 505–21–20 Rev A removes the visual action to address the unsafe condition. summarizing each substantive verbal inspection and adds a repetitive FPI. Once final action has been identified, contact received about this final rule.

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Confidential Business Information warranty, thereby reducing the cost For the reasons discussed, I certify CBI is commercial or financial impact on affected operators. that this AD: (1) Is not a ‘‘significant regulatory information that is both customarily and Paperwork Reduction Act action’’ under Executive Order 12866, actually treated as private by its owner. A federal agency may not conduct or and Under the Freedom of Information Act sponsor, and a person is not required to (2) Will not affect intrastate aviation (FOIA) (5 U.S.C. 552), CBI is exempt respond to, nor shall a person be subject in Alaska. from public disclosure. If your to penalty for failure to comply with a comments responsive to this AD contain collection of information subject to the List of Subjects in 14 CFR Part 39 commercial or financial information requirements of the Paperwork Air transportation, Aircraft, Aviation that is customarily treated as private, Reduction Act unless that collection of safety, Incorporation by reference, that you actually treat as private, and information displays a currently valid Safety. that is relevant or responsive to this AD, OMB Control Number. The OMB Adoption of the Amendment it is important that you clearly designate Control Number for this information the submitted comments as CBI. Please collection is 2120–0056. Public Accordingly, under the authority mark each page of your submission reporting for this collection of delegated to me by the Administrator, containing CBI as ‘‘PROPIN.’’ The FAA information is estimated to be the FAA amends 14 CFR part 39 as will treat such marked submissions as approximately 1 hour per response, follows: confidential under the FOIA, and they including the time for reviewing PART 39—AIRWORTHINESS will not be placed in the public docket instructions, searching existing data DIRECTIVES of this AD. Submissions containing CBI sources, gathering and maintaining the should be sent to Hal Jensen, Aerospace data needed, and completing and ■ Engineer, Operational Safety Branch, 1. The authority citation for part 39 reviewing the collection of information. continues to read as follows: Compliance & Airworthiness Division, All responses to this collection of FAA National Headquarters, 950 information are mandatory. Send Authority: 49 U.S.C. 106(g), 40113, 44701. L’Enfant Plaza N SW, Washington, DC comments regarding this burden § 39.13 [Amended] 20024; telephone (202) 267–9167; email estimate or any other aspect of this ■ 2. The FAA amends § 39.13 by adding [email protected]. Any commentary collection of information, including the following new airworthiness that the FAA receives which is not suggestions for reducing this burden, to: directive: specifically designated as CBI will be Information Collection Clearance placed in the public docket for this Officer, Federal Aviation 2021–06–06 Bell Textron Canada Limited: rulemaking. Administration, 10101 Hillwood Amendment 39–21473; Docket No. Parkway, Fort Worth, TX 76177–1524. FAA–2021–0144; Project Identifier Regulatory Flexibility Act MCAI–2021–00255–R. The requirements of the Regulatory Authority for This Rulemaking (a) Effective Date Flexibility Act (RFA) do not apply when Title 49 of the United States Code This airworthiness directive (AD) is an agency finds good cause pursuant to specifies the FAA’s authority to issue effective March 31, 2021. 5 U.S.C. 553 to adopt a rule without rules on aviation safety. Subtitle I, (b) Affected ADs prior notice and comment. Because the section 106, describes the authority of FAA has determined that it has good the FAA Administrator. Subtitle VII: This AD replaces Emergency AD 2021–05– cause to adopt this rule without prior Aviation Programs, describes in more 52, Project Identifier MCAI–2021–00217–R, dated February 22, 2021. notice and comment, RFA analysis is detail the scope of the Agency’s not required. authority. (c) Applicability Costs of Compliance The FAA is issuing this rulemaking This AD applies to Bell Textron Canada under the authority described in Limited Model 505 helicopters, serial The FAA estimates that this AD Subtitle VII, Part A, Subpart III, Section numbers 65011 and subsequent, certificated affects 88 helicopters of U.S. Registry. 44701: General requirements. Under in any category. Labor rates are estimated at $85 per that section, Congress charges the FAA (d) Subject work-hour. Based on these numbers, the with promoting safe flight of civil FAA estimates the following costs to Joint Aircraft Service Component (JASC) aircraft in air commerce by prescribing Code: 6710, Main Rotor Control. comply with this AD. regulations for practices, methods, and Removing, cleaning, performing the procedures the Administrator finds (e) Unsafe Condition FPI of the pilot collective stick, and necessary for safety in air commerce. This AD was prompted by a report of a installing a serviceable pilot collective This regulation is within the scope of cracked pilot collective stick. The FAA is stick takes about 3 work-hours for an that authority because it addresses an issuing this AD to detect a cracked pilot estimated cost of $255 per helicopter unsafe condition that is likely to exist or collective stick which, if not corrected, could and $22,440 for the U.S. fleet per result in failure of the pilot collective stick develop on products identified in this and subsequent loss of control of the inspection cycle. A replacement pilot rulemaking action. helicopter. collective stick costs about $1,979 per helicopter. If required, reporting Regulatory Findings (f) Compliance information takes about 1 work-hour for This AD will not have federalism Comply with this AD within the an estimated cost of $85 per instance. implications under Executive Order compliance times specified, unless already Revising the existing RFM for your 13132. This AD will not have a done. helicopter takes about 0.5 work-hour for substantial direct effect on the States, on (g) Required Actions an estimated cost of $43 per helicopter. the relationship between the national (1) Before further flight after the effective The FAA has included all known Government and the States, or on the date of this AD, revise the Limitations section costs in its cost estimate. According to distribution of power and of the existing Rotorcraft Flight Manual the manufacturer, however, some of the responsibilities among the various (RFM) for your helicopter by inserting Bell costs of this AD may be covered under levels of government. 505 RFM Temporary Revision (TR) for Pilot

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Collective (ASB 505–21–20), BHT–505–FM– (j) Alternative Methods of Compliance Issued on March 10, 2021. 1, Temporary Revision (TR–6) or Bell 505 (AMOCs) Lance T. Gant, RFM TR for Pilot Collective (ASB 505–21– (1) The Manager, International Validation Director, Compliance & Airworthiness 20), BHT–505–FM–2, Temporary Revision Branch, FAA, has the authority to approve Division, Aircraft Certification Service. (TR–1), each dated March 3, 2021, as AMOCs for this AD, if requested using the [FR Doc. 2021–05513 Filed 3–12–21; 4:15 pm] applicable to your helicopter. Using a procedures found in 14 CFR 39.19. In BILLING CODE 4910–13–P different document with information accordance with 14 CFR 39.19, send your identical to the information for the ‘‘Flight request to your principal inspector or local Crew’’ and ‘‘Configuration,’’ as applicable to Flight Standards District Office, as your helicopter, in the RFM TR specified in appropriate. If sending information directly DEPARTMENT OF HOUSING AND this paragraph for your helicopter is to the manager of the International Validation URBAN DEVELOPMENT acceptable for compliance with the office, send it to the attention of the person requirements of this paragraph. This action identified in paragraph (k)(1) of this AD. 24 CFR Parts 28, 30, 87, 180, and 3282 may be performed by the owner/operator Information may be emailed to: 9-AVS-AIR- [Docket No. FR–6252–F–01] (pilot) holding at least a private pilot [email protected]. certificate and must be entered into the (2) Before using any approved AMOC, Adjustment of Civil Monetary Penalty aircraft records showing compliance with notify your appropriate principal inspector, Amounts for 2021 this AD in accordance with § 43.9(a)(1) or lacking a principal inspector, the manager through (4) and § 91.417(a)(2)(v). The record of the local flight standards district office/ AGENCY: Office of the General Counsel, must be maintained as required by § 91.417, certificate holding district office. HUD. § 121.380, or § 135.439. (2) Before further flight after the effective (k) Related Information ACTION: Final rule. date of this AD, and thereafter at intervals not (1) Hal Jensen, Aerospace Engineer, SUMMARY: This rule provides for 2021 to exceed 25 hours time-in-service: Operational Safety Branch, Compliance & inflation adjustments of civil monetary (i) Remove the pilot collective stick and Airworthiness Division, FAA National grip assembly from the jackshaft assembly Headquarters, 950 L’Enfant Plaza N SW, penalty amounts required by the Federal and clean the areas specified in Figure 2 of Washington, DC 20024; telephone (202) 267– Civil Penalties Inflation Adjustment Act Bell Alert Service Bulletin 505–21–20, 9167; email [email protected]. of 1990, as amended by the Federal Revision B, dated March 3, 2021 (ASB 505– (2) The subject of this AD is addressed in Civil Penalties Inflation Adjustment Act 21–20 Rev B) with a clean cloth C–516C or Transport Canada Emergency AD CF–2021– Improvements Act of 2015. equivalent moistened with dry cleaning 05R2, dated March 4, 2021. You may view DATES: Effective April 15, 2021. solvent C–304 or equivalent. the Transport Canada AD on the internet at FOR FURTHER INFORMATION CONTACT: (ii) Perform a fluorescent penetrant https://www.regulations.gov in Docket No. Aaron Santa Anna, Associate General inspection (FPI) for a crack by following the FAA–2021–0144. Accomplishment Instructions, paragraph 5. Counsel for Legislation and Regulations, (l) Material Incorporated by Reference (but not paragraphs 5.a. and b.) of ASB 505– Office of the General Counsel, 21–20 Rev B. Perform this FPI in the areas (1) The Director of the Federal Register Department of Housing and Urban specified in Figure 2 of ASB 505–21–20 Rev approved the incorporation by reference of Development, 451 7th Street SW, Room B. If there is a crack, before further flight, the service information listed in this 10276, Washington, DC 20024; remove the pilot collective stick and grip paragraph under 5 U.S.C. 552(a) and 1 CFR telephone number 202–402–5138 (this assembly from service. part 51. is not a toll-free number). Hearing- or (3) Within 10 days after the discovery of (2) You must use this service information speech-impaired individuals may access any crack, report the information specified in as applicable to do the actions required by this number via TTY by calling the paragraph 5.a. of ASB 505–21–20 Rev B to this AD, unless the AD specifies otherwise. (i) Bell Alert Service Bulletin 505–21–20, Federal Relay Service at 800–877–8339 Bell Product Support Engineering at (this is a toll-free number). [email protected]. Revision B, dated March 3, 2021. (4) As of the effective date of this AD, do (ii) Bell 505 Rotorcraft Flight Manual SUPPLEMENTARY INFORMATION: Temporary Revision for Pilot Collective (ASB not install any pilot collective stick and grip I. Background assembly on any helicopter unless the 505–21–20), BHT–505–FM–1, Temporary actions required by paragraphs (g)(2)(i) and Revision (TR–6), dated March 3, 2021. The Federal Civil Penalties Inflation (ii) have been accomplished. (iii) Bell 505 Rotorcraft Flight Manual Adjustment Act Improvements Act of (5) As of the effective date of this AD, relief Temporary Revision for Pilot Collective (ASB 2015 (the 2015 Act) (Pub. L. 114–74, under any Master Minimum Equipment List 505–21–20), BHT–505–FM–2, Temporary Sec. 701), which further amended the or Minimum Equipment List for the Audio Revision (TR–1), dated March 3, 2021. Federal Civil Penalties Inflation (3) For service information identified in Panel is prohibited when the aircraft is Adjustment Act of 1990 (Pub. L. 101– operated with a single pilot. this AD, contact Bell Textron Canada Limited, 12,800 Rue de l’Avenir, Mirabel, 410), requires agencies to make annual (h) Credit for Previous Actions Quebec J7J1R4; telephone (450) 437–2862 or adjustments to civil monetary penalty If you performed an FPI of the pilot (800) 363–8023; fax (450) 433–0272; or at (CMP) amounts for inflation collective stick and grip assembly before the https://www.bellcustomer.com. ‘‘notwithstanding section 553 of title 5, effective date of this AD using Bell Alert (4) You may view this service information United States Code.’’ Section 553 refers Service Bulletin 505–21–20, dated February at the FAA, Office of the Regional Counsel, to the Administrative Procedure Act, 20, 2021, or Bell Alert Service Bulletin 505– Southwest Region, 10101 Hillwood Pkwy., which provides for advance notice and 21–20, Revision A, dated February 26, 2021, Room 6N–321, Fort Worth, TX 76177. For public comment during the rulemaking you met the before further flight FPI information on the availability of this process. However, as explained in requirement of paragraph (g)(2) of this AD. material at the FAA, call (817) 222–5110. Section III below, HUD has determined (5) You may view this service information that advance notice and public (i) Special Flight Permits that is incorporated by reference at the A special flight permit to a maintenance National Archives and Records comment on this final rule is facility may be granted provided that: Administration (NARA). For information on unnecessary. (1) There are no passengers on-board, the availability of this material at NARA, This annual adjustment is for 2021. (2) The helicopter is flown from the copilot email: [email protected], or go to: The annual adjustment is based on the seat only, and https://www.archives.gov/federal-register/cfr/ percent change between the U.S. (3) The GMA (intercom) is operative. ibr-locations.html. Department of Labor’s Consumer Price

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Index for All Urban Consumers (‘‘CPI– money penalty amounts. Since HUD is penalty. In the third column U’’) for the month of October preceding not applying these adjustments (‘‘Regulatory Citation’’), HUD provides the date of the adjustment, and the CPI– retroactively, the 2021 increases apply the Code of Federal Regulations citation U for October of the prior year (28 to violations occurring on or after this under Title 24 for the penalty. In the U.S.C. 2461 note, section (5)(b)(1)). rule’s effective date. HUD provides a fourth column (‘‘Previous Amount’’), Based on that formula, the cost-of-living table showing how, for each component, HUD provides the amount of the penalty adjustment multiplier for 2021 is the penalties are being adjusted for 2021 pursuant to the rule implementing the 1 1.01182. Pursuant to the 2015 Act, pursuant to the 2015 Act. In the first 2020 adjustment (85 FR 13041, April 06, adjustments are rounded to the nearest column (‘‘Description’’), HUD provides 2 2020). In the fifth column (‘‘2021 dollar. a description of the penalty. In the Adjusted Amount’’), HUD lists the II. This Final Rule second column (‘‘Statutory Citation’’), penalty after applying the 2021 inflation This final rule makes the required HUD provides the United States Code adjustment. 2021 inflation adjustment of HUD’s civil statutory citation providing for the

Regulatory Description Statutory citation citation Previous amount 2021 adjusted amount (24 CFR)

False Claims ...... Omnibus Budget Reconciliation § 28.10(a) ...... $11,665 ...... $11,803. Act of 1986 (31 U.S.C. 3802(a)(1)). False Statements ...... Omnibus Budget Reconciliation § 28.10(b) ...... $11,665 ...... $11,803. Act of 1986 (31 U.S.C. 3802 (a)(2)). Advance Disclosure of Funding .... Department of Housing and Urban § 30.20 ...... $20,489 ...... $20,731. Development Act (42 U.S.C. 3537a(c)). Disclosure of Subsidy Layering ..... Department of Housing and Urban § 30.25 ...... $20,489 ...... $20,731. Development Act (42 U.S.C. 3545(f)). FHA Mortgagees and Lenders HUD Reform Act of 1989 (12 § 30.35 ...... Per Violation: $10,245; Per Year: Per Violation: $10,366; Per Year: Violations. U.S.C. 1735f–14(a)(2)). $2,048,915. $2,073,133. Other FHA Participants Violations HUD Reform Act of 1989 (12 § 30.36 ...... Per Violation: $10,245; Per Year: Per Violation: $10,366; Per Year: U.S.C. 1735f–14(a)(2)). $2,048,915. $2,073,133. Indian Loan Mortgagees Violations Housing Community Development § 30.40 ...... Per Violation: $10,245; Per Year: Per Violation: $10,366; Per Year: Act of 1992 (12 U.S.C. 1715z– $2,048,915. $2,073,133. 13a(g)(2)). Multifamily & Section 202 or 811 HUD Reform Act of 1989 (12 § 30.45 ...... $51,222 ...... $51,827 Owners Violations. U.S.C. 1735f–15(c)(2)). Ginnie Mae Issuers & Custodians HUD Reform Act of 1989 (12 § 30.50 ...... Per Violation: $10,245; Per Year: Per Violation: $10,366; Per Year: Violations. U.S.C. 1723i(a)). $2,048,915. $2,073,133. Title I Broker & Dealers Violations HUD Reform Act of 1989 (12 § 30.60 ...... Per Violation: $10,245; Per Year: Per Violation: $10,366; Per Year: U.S.C. 1703). $2,048,915. $2,073,133. Lead Disclosure Violation ...... Title X—Residential Lead-Based § 30.65 ...... $18,149 ...... $18,364. Paint Hazard Reduction Act of 1992 (42 U.S.C. 4852d(b)(1)). Section 8 Owners Violations ...... Multifamily Assisted Housing Re- § 30.68 ...... $39,811 ...... $40,282. form and Affordability Act of 1997 (42 U.S.C. 1437z–1(b)(2)). Lobbying Violation ...... The Lobbying Disclosure Act of § 87.400 ...... Min: $20,489; Max: $204,892 ...... Min: $20,731; Max: $207,314. 1995 (31 U.S.C. 1352). Fair Housing Act Civil Penalties .... Fair Housing Act (42 U.S.C. § 180.671(a) ...... No Priors: $21,410; One Prior: No Priors: $21,663; One Prior: 3612(g)(3)). $53,524; Two or More Priors: $54,157; Two or More Priors: $107,050. $108,315. Manufactured Housing Regula- Housing Community Development § 3282.10 ...... Per Violation: $2,976; Per Year: Per Violation: $3,011; Per Year: tions Violation. Act of 1974 (42 U.S.C. 5410). $3,719,428. $3,763,392.

III. Justification for Final Rulemaking unnecessary, or contrary to the public the 2021 inflation adjustments to solicit for the 2021 Adjustments interest’’ (see 24 CFR 10.1). As public comments. discussed, this final rule makes the HUD generally publishes regulations Section 7(o) of the Department of required 2021 inflation adjustment, Housing and Urban Development Act for public comment before issuing a rule which HUD does not have discretion to for effect, in accordance with its own (42 U.S.C. 3535(o)) requires that any change. Moreover, the 2015 Act regulations on rulemaking in 24 CFR HUD regulation implementing any specifies that a delay in the effective part 10. However, part 10 provides for provision of the Department of Housing date under the Administrative exceptions to the general rule if the and Urban Development Reform Act of Procedure Act is not required for annual agency finds good cause to omit 1989 that authorizes the imposition of a advanced notice and public adjustments under the 2015 Act. HUD civil money penalty may not become participation. The good cause has determined, therefore, that it is effective until after the expiration of a requirement is satisfied when prior unnecessary to delay the effectiveness of public comment period of not less than public procedure is ‘‘impractical, 60 days. This rule does not authorize

1 Office of Management and Budget, M–21–10, the Federal Civil Penalties Inflation Adjustment Act M-21-10.pdf). (October 2020 CPI–U (260.388)/ Memorandum for the Heads of Executive Improvements Act of 2015. (https:// October 2019 CPI–U (257.346) = 1.01182.) Departments and Agencies, Implementation of www.whitehouse.gov/wp-content/uploads/2020/12/ 2 28 U.S.C. 2461 note. Penalty Inflation Adjustments for 2021, Pursuant to

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the imposition of a civil money requirement to publish an initial or final List of Subjects penalty—rather, it makes a standard regulatory flexibility analysis under the 24 CFR Part 28 inflation adjustment to penalties that RFA as part of such action. were previously authorized. As noted Administrative practice and above, the 2021 inflation adjustments Unfunded Mandates Reform procedure, Claims, Fraud, Penalties. are made in accordance with a Section 202 of the Unfunded 24 CFR Part 30 statutorily prescribed formula that does Mandates Reform Act of 1995 (UMRA) 3 not provide for agency discretion. requires that an agency prepare a Administrative practice and Accordingly, a delay in the effectiveness budgetary impact statement before procedure, Grant programs—housing of the 2021 inflation adjustments in promulgating a rule that includes a and community development, Loan order to provide the public with an Federal mandate that may result in the programs—housing and community opportunity to comment is unnecessary expenditure by State, local, and tribal development, Mortgage insurance, because the 2015 Act exempts the governments, in the aggregate, or by the Penalties. adjustments from the need for delay, the private sector, of $100 million or more 24 CFR Part 87 rule does not authorize the imposition in any one year. If a budgetary impact of a civil money penalty, and, in any statement is required, section 205 of Government contracts, Grant event, HUD would not have the UMRA also requires an agency to programs, Loan programs, Lobbying, discretion to make changes as a result of identify and consider a reasonable Penalties, Reporting and recordkeeping any comments. number of regulatory alternatives before requirements. IV. Findings and Certifications promulgating a rule.4 However, the 24 CFR Part 180 UMRA applies only to rules for which Regulatory Review—Executive Orders an agency publishes a general notice of Administrative practice and 12866 and 13563 proposed rulemaking. As discussed procedure, Aged, Civil rights, Fair Under Executive Order 12866 above, HUD has determined, for good housing, Persons with disabilities, (Regulatory Planning and Review) (58 cause, that prior notice and public Investigations, Mortgages, Penalties, FR 51735), a determination must be comment is not required on this rule Reporting and recordkeeping requirements. made whether a regulatory action is and, therefore, the UMRA does not significant and, therefore, subject to apply to this final rule. 24 CFR Part 3282 review by the Office of Management and Budget (OMB) in accordance with the Executive Order 13132, Federalism Administrative practice and requirements of the order. Executive procedure, Consumer protection, Executive Order 13132 (entitled Order 13563 (Improving Regulations Intergovernmental relations, ‘‘Federalism’’) (64 FR 43255) prohibits and Regulatory Review) (76 FR 3821) Manufactured homes, Reporting and an agency from publishing any rule that directs executive agencies to analyze recordkeeping requirements. has federalism implications if the rule regulations that are ‘‘outmoded, Accordingly, for the reasons described either imposes substantial direct ineffective, insufficient, or excessively in the preamble, HUD amends 24 CFR compliance costs on State and local burdensome, and to modify, streamline, parts 28, 30, 87, 180, and 3282 to read governments and is not required by expand, or repeal them in accordance as follows: with what has been learned.’’ Executive statute, or the rule preempts State law, Order 13563 also directs that, where unless the agency meets the PART 28—IMPLEMENTATION OF THE relevant, feasible, and consistent with consultation and funding requirements PROGRAM FRAUD CIVIL REMEDIES regulatory objectives, and to the extent of section 6 of the Executive Order. This ACT OF 1986 permitted by law, agencies are to rule will not have federalism identify and consider regulatory implications and would not impose ■ 1. The authority citation for part 28 approaches that reduce burdens and substantial direct compliance costs on continues to read as follows: maintain flexibility and freedom of State and local governments or preempt State law within the meaning of the Authority: 28 U.S.C. 2461 note; 31 U.S.C. choice for the public. As discussed 3801–3812; 42 U.S.C. 3535(d). above in this preamble, this final rule Executive order. ■ 2. In § 28.10, revise paragraphs (a)(1) adjusts existing civil monetary penalties Environmental Review introductory text and (b)(1) introductory for inflation by a statutorily required text to read as follows: amount. HUD determined that this rule This final rule does not direct, was not significant under Executive provide for assistance or loan and § 28.10 Basis for civil penalties and Order 12866 and Executive Order mortgage insurance for, or otherwise assessments. govern, or regulate, real property 13563. (a) * * *. (1) A civil penalty of not acquisition, disposition, leasing, more than $11,803 may be imposed Regulatory Flexibility Act rehabilitation, alteration, demolition, or upon any person who makes, presents, The Regulatory Flexibility Act (RFA) new construction, or establish, revise, or or submits, or causes to be made, (5 U.S.C. 601 et seq.) generally requires provide for standards for construction or presented, or submitted, a claim that the an agency to conduct a regulatory construction materials, manufactured person knows or has reason to know: flexibility analysis of any rule subject to housing, or occupancy. Accordingly, notice and comment rulemaking under 24 CFR 50.19(c)(1), this final rule * * * * * requirements, unless the agency certifies is categorically excluded from (b) * * *. (1) A civil penalty of not that the rule will not have a significant environmental review under the more than $11,803 may be imposed economic impact on a substantial National Environmental Policy Act of upon any person who makes, presents, number of small entities. Because HUD 1969 (42 U.S.C. 4321). or submits, or causes to be made, has determined that good cause exists to presented, or submitted, a written issue this rule without prior public 3 2 U.S.C. 1532. statement that: comment, this rule is not subject to the 4 2 U.S.C. 1535. * * * * *

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PART 30—CIVIL MONEY PENALTIES: ■ 10. In § 30.50, revise the first sentence determined by the agency head or his or CERTAIN PROHIBITED CONDUCT in paragraph (c) to read as follows: her designee. * * * * * ■ 3. The authority citation for part 30 § 30.50 GNMA issuers and custodians. continues to read as follows: * * * * * PART 180—CONSOLIDATED HUD Authority: 12 U.S.C. 1701q–1, 1703, 1723i, (c) *** The maximum penalty is HEARING PROCEDURES FOR CIVIL 1735f–14, and 1735f–15; 15 U.S.C. 1717a; 28 $10,366 for each violation, up to a limit RIGHTS MATTERS U.S.C. 1 note and 2461 note; 42 U.S.C. of $2,073,133 during any one-year 1437z–1 and 3535(d). period. * * * ■ 16. The authority citation for part 180 ■ 4. In § 30.20, revise paragraph (b) to ■ 11. In § 30.60, revise paragraph (c) to continues to read as follows: read as follows: read as follows: Authority: 28 U.S.C. 1 note; 29 U.S.C. 794; 42 U.S.C. 2000d–1, 3535(d), 3601–3619, § 30.20 Ethical violations by HUD § 30.60 Dealers or sponsored third-party 5301–5320, and 6103. employees. originators. * * * * * * * * * * ■ 17. In § 180.671, revise paragraphs (b) Maximum penalty. The maximum (c) Amount of penalty. The maximum (a)(1) through (3) to read as follows: penalty is $20,731 for each violation. penalty is $10,366 for each violation, up § 180.671 Assessing civil penalties for Fair ■ 5. In § 30.25, revise paragraph (b) to to a limit for any particular person of Housing Act cases. read as follows: $2,073,133 during any one-year period. ■ 12. In § 30.65, revise paragraph (b) to (a) * * * § 30.25 Violations by applicants for read as follows: (1) $21,663, if the respondent has not assistance. been adjudged in any administrative * * * * * § 30.65 Failure to disclose lead-based hearing or civil action permitted under (b) Maximum penalty. The maximum paint hazards. the Fair Housing Act or any state or penalty is $20,731 for each violation. * * * * * local fair housing law, or in any ■ 6. In § 30.35, revise the first sentence (b) Amount of penalty. The maximum licensing or regulatory proceeding in paragraph (c)(1) to read as follows: penalty is $18,364 for each violation. conducted by a federal, state, or local ■ governmental agency, to have § 30.35 Mortgagees and lenders. 13. In § 30.68, revise paragraph (c) to read as follows: committed any prior discriminatory * * * * * housing practice. (c)(1) * * * The maximum penalty is § 30.68 Section 8 owners. (2) $54,157, if the respondent has $10,366 for each violation, up to a limit * * * * * of $2,073,133 for all violations been adjudged in any administrative (c) Maximum penalty. The maximum hearing or civil action permitted under committed during any one-year period. penalty for each violation under this *** the Fair Housing Act, or under any state section is $40,282. or local fair housing law, or in any * * * * * * * * * * licensing or regulatory proceeding ■ 7. In § 30.36, revise the first sentence conducted by a federal, state, or local in paragraph (c) to read as follows: PART 87—NEW RESTRICTIONS ON government agency, to have committed LOBBYING § 30.36 Other participants in FHA one other discriminatory housing practice and the adjudication was made programs. ■ 14. The authority citation for part 87 during the 5-year period preceding the * * * * * continues to read as follows: (c) * * * The maximum penalty is date of filing of the charge. Authority: 28 U.S.C. 1 note; 31 U.S.C. (3) $108,315, if the respondent has $10,366 for each violation, up to a limit 1352; 42 U.S.C. 3535(d). of $2,073,133 for all violations been adjudged in any administrative committed during any one-year period. ■ 15. In § 87.400, revise paragraphs (a), hearings or civil actions permitted *** (b), and (e) to read as follows: under the Fair Housing Act, or under any state or local fair housing law, or in ■ 8. In § 30.40, revise the first sentence § 87.400 Penalties. in paragraph (c) to read as follows: any licensing or regulatory proceeding (a) Any person who makes an conducted by a federal, state, or local § 30.40 Loan guarantees for Indian expenditure prohibited herein shall be government agency, to have committed housing. subject to a civil penalty of not less than two or more discriminatory housing * * * * * $20,731 and not more than $207,314 for practices and the adjudications were (c) *** The maximum penalty is each such expenditure. made during the 7-year period $10,366 for each violation, up to a limit (b) Any person who fails to file or preceding the date of filing of the of $2,073,133 for all violations amend the disclosure form (see charge. appendix B of this part) to be filed or committed during any one-year period. * * * * * *** amended if required herein, shall be ■ 9. In § 30.45, revise paragraph (g) to subject to a civil penalty of not less than PART 3282—MANUFACTURED HOME read as follows: $20,731 and not more than $207,314 for PROCEDURAL AND ENFORCEMENT each such failure. REGULATIONS § 30.45 Multifamily and section 202 or 811 * * * * * mortgagors. (e) First offenders under paragraphs ■ 18. The authority citation for part * * * * * (a) or (b) of this section shall be subject 3282 continues to read as follows: (g) Maximum penalty. The maximum to a civil penalty of $20,731, absent penalty for each violation under Authority: 15 U.S.C. 2967; 42 U.S.C. aggravating circumstances. Second and 3535(d), 5403, and 5424. paragraphs (c) and (f) of this section is subsequent offenses by persons shall be $51,827. subject to an appropriate civil penalty ■ 19. Revise § 3282.10 to read as * * * * * between $20,731 and $207,314 as follows:

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§ 3282.10 Civil and criminal penalties. FOR FURTHER INFORMATION CONTACT: Jerry disability assistance services. The Failure to comply with these Elliott, U.S. Department of Education, commenters believe that the AIVRS regulations may subject the party in 400 Maryland Avenue SW, Room 5097, program is a great way to help this question to the civil and criminal Potomac Center Plaza, Washington, DC group. The commenters believe that penalties provided for in section 611 of 20202–2800. Telephone: (202) 245– Proposed Priority 1 would help. the Act, 42 U.S.C. 5410. The maximum 7335. Email: [email protected]. Discussion: The Department agrees amount of penalties imposed under If you use a telecommunications with the commenters that Proposed section 611 of the Act shall be $3,011 device for the deaf (TDD) or a text Priority 1 is important in helping the for each violation, up to a maximum of telephone (TTY), call the Federal Relay AIVRS projects to deliver AIVRS $3,763,392 for any related series of Service (FRS), toll free, at 1–800–877– services to American Indians with violations occurring within one year 8339. disabilities served by the AIVRS from the date of the first violation. SUPPLEMENTARY INFORMATION: projects. Purpose of Program: The purpose of Changes: None. Damon Smith, the AIVRTTAC program is to provide Comment: One commenter discussed Principal Deputy General Counsel. training and TA to governing bodies of the need to build internal capacity [FR Doc. 2021–04817 Filed 3–15–21; 8:45 am] Indian Tribes, or consortia of those within AIVRS projects to deliver benefits counseling to AIVRS project BILLING CODE 4210–67–P governing bodies, that have received an participants. The commenter noted that AIVRS grant under section 121(a) of the benefits counseling is a proven Rehabilitation Act of 1973, as amended approach that not only helps (Act). Under section 121(c)(2) of the Act, DEPARTMENT OF EDUCATION individuals understand the benefits of the Commissioner of the Rehabilitation work but also leads to more 34 CFR Chapter III Services Administration (RSA) makes employment outcomes. The commenter grants to, or enters into contracts or stated that benefits counseling provided [Docket ID ED–2020–OSERS–0063] other cooperative agreements with, within Tribal programs will be more entities that have experience in the Final Priority and Definitions— welcome and better accepted than American Indian Vocational operation of AIVRS projects to provide benefits counseling provided by Rehabilitation Training and Technical such training and TA on developing, ‘‘outsiders’’ who provide counseling Assistance Center conducting, administering, and and then leave. Specifically, the evaluating these projects. commenter recommended that the AGENCY: Office of Special Education and Program Authority: 29 U.S.C. 741(c). AIVRTTAC institute a plan to provide Rehabilitative Services (OSERS), AIVRS consumers with benefits Department of Education. Applicable Program Regulations: 34 CFR part 371. planning services by training Tribal ACTION: Final priority and definitions. We published a notice of proposed members to provide these services and build expert capacity within the Tribal SUMMARY: The Department of Education priorities and definitions (NPP) for this program in the Federal Register on nations so that consumers can learn and (Department) announces a priority and understand the process and complex definitions to fund an American Indian September 10, 2020 (85 FR 55802). That notice contained background rules of government programs. Vocational Rehabilitation Training and Discussion: The Department agrees Technical Assistance Center information and our reasons for proposing the particular priorities and with the commenter that benefits (AIVRTTAC), Assistance Listing counseling services are important Number 84.250Z. The Department may definitions. Except for minor editorial and services to provide to AIVRS consumers use the priority and definitions for technical revisions for grammar and as they work to develop their career competitions in fiscal year (FY) 2021 clarity, and one substantive change goals and their individualized plan for and later years. We take this action to explained in the discussion of the employment (IPE). Benefits counseling improve employment outcomes and comments that follow, there are no is a commonly provided VR service. The raise expectations for American Indians differences between Proposed Priority 1 Department agrees that the AIVRTTAC with disabilities and to fund training and the proposed definitions and the should be able to provide TA to Tribes and technical assistance (TA) activities final priority and final definitions. We seeking to build resources to provide to support the American Indian have not included Proposed Priority 2 these services and will address it in the Vocational Rehabilitation Services in the final priorities. cooperative agreement once the (AIVRS) projects. We intend the Public Comment: In response to our applicant is selected, but the priority AIVRTTAC to provide training and TA invitation in the NPP, five parties addresses broader requirements for to the AIVRS project personnel, submitted comments on the proposed training such as development of the IPE, especially vocational rehabilitation (VR) priorities and definitions. which looks at all VR services, of which counselors, to improve their capacity to Generally, we do not address benefits counseling is one. The implement innovative and effective VR technical and other minor changes, or Department does not believe that the services and employment strategies and suggested changes the law does not one-size-fits-all approach suggested by practices to increase the number and authorize us to make. In addition, we do the commenter—to require the quality of employment outcomes for not address general comments that raise AIVRTTAC to train all AIVRS grantees American Indians with disabilities concerns not directly related to the on benefits counseling—is the best served through the AIVRS program. proposed priorities or definitions. approach given the diversity of the Awards will be made to State, local, Analysis of Comments and Changes: AIVRS grantees. Many small AIVRS or Tribal governments, non-profit An analysis of the comments and of any projects may not have the capacity to organizations, or institutions of higher changes in the priorities and definitions devote staff time to this complicated education that have experience in the since publication of the NPP follows. issue and would need TA to establish operation of AIVRS programs. Comment: Two commenters noted relationships with other sources to DATES: This priority and definitions are that American Indians, just like other address this need. Also, there may be effective April 15, 2021. groups, deserve rehabilitation and local services available that have proven

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effective, or there may be collaborative and benefit the AIVRS consumers the the value that a matching requirement approaches with other Tribal programs employee serves, even if the class is not might otherwise generate through or external programs that could address taken for academic credit. greater institutional investment in the this need. The Department believes that Changes: We have revised Proposed grant activity. the specific method of providing Priority 1 to require that the AIVRTTAC Changes: We have removed Proposed benefits counseling services is best left provide an academic credit option for Priority 2. courses offered that lead to a certificate to the specific AIVRS project and Tribal Final Priority organizations to determine, with the in AIVRS and added language to AIVRTTAC providing TA as appropriate encourage the inclusion of an academic American Indian Vocational and as requested by the AIVRS project. path that allows certificate courses Rehabilitation Services—Training and Changes: None. taken for academic credit to lead to a Technical Assistance Program Comment: One commenter advocated degree. This priority funds a five-year that any TA provided that results in the Comment: Regarding Proposed cooperative agreement to establish an successful attainment of a certificate be Priority 2, one commenter stated that American Indian Vocational offered only for academic credit and the match requirement should be the Rehabilitation Training and Technical that certificates of a non-academic smallest percentage possible and that Assistance Center (AIVRTTAC) to nature be only offered as incremental foregone indirect funds should be provide four types of training and steps that would ultimately result in allowable as an in-kind match because technical assistance (TA) for the academic credit, resulting in a terminal the commenter’s organization within a personnel of the American Indian degree in American Indian Vocational university structure is funded by grant Vocational Rehabilitation Services Rehabilitation Services. The commenter and contract revenue and has only (AIVRS) projects awarded under section stated that when an individual self- limited other funds that could be used 121(a) of the Rehabilitation Act of 1973, identifies as an American Indian VR for match purposes. The commenter as amended (Act), to the governing professional, the individual should be also stated that potential applicants, bodies of Indian Tribes and consortia of striving to be on a career-long learning such as small colleges and Tribal those governing bodies. The four types endeavor to perform at their highest entities, have limited funds available for of training and TA are: (1) Intensive potential for the clients they serve. match and that a match requirement training and TA; (2) targeted training AIVRS agencies need personnel who will limit the diversity of applicants. and TA; (3) universal training and TA; Discussion: The Department agrees choose this work as a career option, and and (4) capacity-building for AIVRS that requirements in the proposed academic degrees are an avenue project personnel through training priority that would limit the potential whereby an individual makes these modules that build foundational skills applicant pool are not desirable. In career choices. for the delivery of VR services to AIVRS Discussion: The Department agrees particular, there are a number of project participants. The AIVRTTAC with the commenter that an academic institutions of higher education (IHEs) will develop and provide these types of credit option needs to be available for operated by Tribes that would bring training and TA for AIVRS projects in the courses offered for completion of a cultural relevance and practical the following topic areas: certificate in American Indian experience in the operation of workforce (a) Applicable laws and regulations Vocational Rehabilitation Services. related programs in Tribal areas. While governing the AIVRS program. Proposed Priority 1 allows VR Tribal IHEs vary in size, funding, and (b) Promising practices for providing professionals from the AIVRS projects to location, it is possible that a match VR services to American Indians with decide to take certificate courses for no requirement would deter a Tribal IHE disabilities. academic credit if they so choose. The from becoming an applicant or a partner (c) The delivery of VR services to Department will modify the priority to in an application. Applications with American Indians with disabilities, require that the AIVRTTAC offer an multiple partners generally require the including the determination of academic option in addition to a non- participating organizations to furnish eligibility, case management, case academic option and allow the the matching funds for the portion of record documentation, assessment, applicant to determine the designation the grant they receive. Thus, a match development of the individualized plan and requirements for each. requirement could discourage for employment, and placement into In addition, the Department will participation even as a partner in an competitive integrated employment. revise the proposed priority to application. (d) Knowledge of assistive technology encourage but not require an academic The Department also recognizes that (AT), including the definition of AT, path whereby certificate courses taken the COVID–19 pandemic is not abating, how to evaluate the need for AT and for academic credit could lead to a especially in Tribal communities, and what types of AT are available, use of degree in vocational rehabilitation or a that the impact of the pandemic is AT, and access to AT. closely related field. While an academic causing revenue challenges for State and (e) Implementing professional path leading to a degree is important, Tribal governments and State and Tribal development practices to ensure the Department does not agree that an IHEs, making the provision of matching effective project coordination, academic path should be the only funds even more difficult. administration, and management. option. AIVRS projects hire staff at The proposed matching requirement (f) Implementing appropriate financial different levels in the organization, and is not required by statute. Because the and grant management practices to certificate course knowledge could be Department wishes to invite ensure compliance with OMB’s Uniform helpful to staff at all levels of the applications from the broadest range of Guidance (2 CFR part 200) and the organization. In addition, there may be applicants, and because most of the Education Department General individuals who bring great cultural or eligible applicant pool is also Administrative Regulations. work experience to the AIVRS project economically affected by the COVID–19 (g) Evaluating project performance, but may not be, for various reasons, able pandemic, the Department has including data collection, data analysis, to pursue a degree. The knowledge determined that the concerns raised by and reporting. gained through a certificate class would the commenter and the others Specific subjects for training and TA nevertheless be helpful to the employee recognized by the Department outweigh in each of these topic areas will be

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identified on an annual basis and in follow-up TA and to determine whether or modify existing platforms and coordination with RSA. this training and TA contributed to systems, as follows: increased employment outcomes for Project Activities (i) Develop or modify, and maintain, American Indians with disabilities; a state-of-the-art IT platform capable To be considered for funding under (vii) Are encouraged to develop a path and reliable enough to support this priority, applicants must conduct by which courses offered for academic webinars, teleconferences, video the following activities, or a subset of credit lead to a degree in Rehabilitation conferences, and other virtual methods the following activities as determined or a related field; and of dissemination of information and TA; by the Department, in a culturally (viii) May develop additional training (ii) Develop or modify, and maintain, appropriate manner: modules as negotiated through the a state-of-the-art archiving and (a) Maintain and build upon the 12 cooperative agreement. dissemination system that is open and training modules and the fiscal tool kit (b) Maintain and build upon the available to all AIVRS projects and that developed by the Tribal Vocational topics and tools the current AIVRRTAC provides a central location for all AIVRS Rehabilitation Institute (the Institute) has developed to provide intensive training and TA products for later use, during Federal fiscal years (FFYs) 2015– training and TA. To satisfy this activity including course curricula, audiovisual 2021, including maintaining the series requirement, the grantee must— materials, webinars, examples of of seven training modules that build (i) Develop and provide intensive promising practices related to the topic foundational skills that, when training and TA to a minimum of three areas in this priority, the primary areas satisfactorily completed, lead to a VR AIVRS projects in the first year. For identified through the annual surveys certificate to be awarded by the future years, the minimum number of completed by AIVRS projects, other AIVRTTAC. To satisfy this activity AIVRS projects to receive intensive topics identified by RSA, and other requirement, the grantee— training and TA will be negotiated relevant TA products (the possibility of (i) Must develop both academic and through the cooperative agreement; collaborating with the National non-academic options for completing (ii) Develop and implement training Clearinghouse of Rehabilitation courses leading to the VR certificate, the and TA consistent with AIVRS project Training Materials will be considered requirements for obtaining a certificate activities and tailored to the specific with the grantee and included in the including the specific requirements for needs and challenges of the AIVRS cooperative agreement, as appropriate); academic credit for courses included in project receiving the intensive training (iii) Ensure that all products produced the certificate when applicable, and and TA; by the AIVRTTAC meet government and how the certificate may be used by the (iii) Provide training and TA under an industry-recognized standards for participants who earn it; (ii) May offer the series of training agreement with each AIVRS project accessibility; and modules in a traditional classroom receiving intensive training and TA that, (iv) Ensure that all products, setting, through distance learning, at a minimum, details the purpose of the resources, and materials developed by through week-long institutes, at regional training and TA, intended outcomes, the AIVRTTAC are widely disseminated trainings throughout the country as an and requirements for the subsequent across the AIVRS projects and reflect extension of national conferences, and evaluation of the training and TA; and the AIVRS population and diversity through other delivery methods, as (iv) Assess the results of the training among its communities to the maximum appropriate, to meet the needs of the and TA 90 days after its completion to extent possible. targeted audience; ensure that the recipient is able to apply (g) Establish a community of practice (iii) May use grant funds to provide effectively the training and TA, identify (or communities of practice) that will reasonable financial assistance for the any issues or challenges in its serve as a vehicle for communication, cost of tuition, fees, and training implementation, and provide additional an exchange of information among materials and to offset costs associated training and TA, either virtually or on- AIVRS projects, and a forum for sharing with travel for participants who may be site, as needed. the results of training and TA projects in remote areas of the country; (c) Maintain and build upon the that are in progress or have been (iv) Must conduct an assessment topics and tools the current AIVRTTAC completed; before and after providing training for has developed to provide a range of (h) Conduct outreach to AIVRS each participant in order to assess targeted training and TA in the topic projects so that they are aware of, and strengths and specific areas for areas described in this priority based on can participate in, training and TA improvement, educational attainment, needs common to multiple AIVRS activities; and and application of skills, and any issues projects. The grantee must follow up (i) Conduct an evaluation to or challenges to be addressed post- with the recipients of targeted training determine the quality, relevance, and training to ensure improved delivery of and TA it provides to determine the usefulness of the AIVRTTAC’s training VR services to American Indians with effectiveness of the training and TA; and TA, including the impact of the disabilities; (d) Maintain and build upon the AIVRTTAC’s activities on the ability of (v) Must provide follow-up TA to topics and tools the current AIVRTTAC AIVRS projects to effectively manage participants to address any issues or has developed to provide universal their projects and improve the delivery challenges that are identified post- training and TA in the topic areas in of VR services to American Indians with training and to ensure that the training this priority; disabilities. (e) Provide a minimum of two they received is applied effectively in Project Requirements their work setting, and such follow-up webinars or video conferences in each may be conducted as part of the of the topic areas in this priority to To be funded under this priority, provision of targeted training and TA or describe and disseminate up-to-date applicants must meet the project intensive training and TA as determined information, guides, examples, and requirements in this priority. RSA by the needs of the specific AIVRS emerging and promising practices in encourages innovative approaches to project; each area; meet these requirements, which are— (vi) Must conduct an evaluation to (f) Develop new information (a) Demonstrate in the narrative obtain feedback on the training and technology (IT) platforms and systems, section of the application under

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‘‘Significance of the Proposed Project’’ (E) A description of how participant Institute in FFYs 2015–2021, including how the proposed project will— knowledge, skills, and abilities will be maintaining the series of seven training (1) Use the applicant’s knowledge and measured; and modules that build foundational skills experience in the operation of AIVRS (F) In the case of an intensive training that, when satisfactorily completed, lead projects to provide training and TA for and TA intervention, how the outcomes to a VR certificate to be awarded by the these projects; and impact of the intensive training and grantee; and (2) Address the AIVRS projects’ TA intervention will be measured; (B) Its proposed approach to capacity to effectively implement an (2) Use a logic model to develop identifying, developing, and delivering AIVRS project. To meet this project plans and activities that new capacity-building modules; and requirement, the applicant must— includes, at a minimum, the goals, (5) Develop products and implement (i) Demonstrate knowledge of activities, outputs, and outcomes of the services to maximize the proposed emerging and promising practices in the proposed project; project’s efficiency. To address this topic areas in this priority; (3) Be based on current research and requirement, the applicant must (ii) Demonstrate knowledge of current make use of emerging and promising describe— RSA guidance and Federal initiatives practices, and evidence-based practices, (i) How the proposed project will use designed to improve the functioning of where available. To meet this technology to achieve the intended grant projects in general and grant requirement the applicant must project outcomes; projects for American Indian Tribes in describe— (ii) With whom the proposed project particular; and (i) The current research on the will collaborate and the intended (iii) Present information about the emerging and promising practices in the outcomes of this collaboration; and (iii) In particular, how the proposed difficulties that AIVRS grantees have topic areas in this priority; and project will coordinate and collaborate encountered in implementing effective (ii) How the AIVRTTAC will with other RSA-funded technical AIVRS projects; incorporate current research and assistance centers to exchange and (b) Demonstrate in the narrative promising and evidence-based practices, adapt relevant products and materials to section of the application under including research about adult learning avoid duplication and make effective ‘‘Quality of Project Design’’ how the principles and implementation science, use of grant funds to better manage the proposed project will— in the development and delivery of its AIVRTTAC project and its available (1) Achieve its goals, objectives, and products and services; resources to improve service delivery to intended outcomes. To meet this (4) Develop products and provide AIVRS projects; requirement, the applicant must services that are of high quality and of (c) Demonstrate in the narrative provide— sufficient intensity and duration to achieve the intended outcomes of the section of the application under (i) Measurable intended project ‘‘Adequacy of Project Resources’’ how— outcomes; proposed project. To address this requirement the applicant must (1) The applicant and any key (ii) A plan for how the proposed partners possess adequate resources to project will achieve its intended describe— (i) Its proposed approach to universal carry out the proposed activities; and outcomes; training and TA; (2) The proposed costs are reasonable (iii) A plan for communicating and (ii) Its proposed approach to targeted in relation to the anticipated results and coordinating with RSA and key training and TA, which must identify— benefits; personnel of AIVRS projects; and (A) The intended recipients of the (d) Demonstrate in the narrative (iv) A draft training module or outline products and services under this section of the application under for a targeted training and TA approach, including the categories of ‘‘Quality of Project Personnel’’ how— presentation or an outline for intensive personnel that would be receiving the (1) The proposed project will training and TA activities for one of the training and TA; encourage applications for employment topic areas in this priority to (B) Its proposed methods for from persons who are members of demonstrate how participants would be providing targeted training and TA; and groups that have historically been trained in that area. The module or (C) Its proposed methodology for underrepresented based on race, color, outline is a required attachment in the determining topics for the targeted national origin, gender, age, or application and must include, at a training and TA; disability, as appropriate; and minimum, the following: (iii) Its proposed approach to (2) The proposed key project (A) The goals and objectives of this intensive training and TA, which must personnel, consultants, and training module, targeted training and identify— subcontractors have the qualifications TA activity, or intensive training and (A) Its proposed approach to and experience to provide training and TA activities; identifying recipients for intensive TA to AIVRS projects in each of the (B) A specific list of what participants training and TA; topic areas in this priority and to should know and be able to do as a (B) Its proposed methodology for achieve the project’s intended result of successfully completing the providing intensive training and TA to outcomes, including how the proposed module, targeted training and TA recipients; and project personnel have a high degree of activity, or intensive training and TA (C) Its proposed approach to assessing knowledge and understanding of activities; the training and TA needs of recipients, cultural factors that will be sufficient to (C) Up-to-date resources, publications, including their ability to respond ensure the delivery of training and TA applicable laws and regulations, and effectively to the training and TA; and in a culturally appropriate manner; other materials that may be used to (iv) Its proposed approach to (e) Demonstrate in the narrative develop the module, targeted training maintaining and building upon section of the application under and TA activity, or intensive training capacity-building modules, which must ‘‘Quality of the Management Plan’’ how and TA activities; identify— the proposed management plan will (D) Exercises that will provide an (A) Its proposed approach to ensure that the project’s intended opportunity for application of the maintaining the 12 training modules outcomes will be achieved on time and subject matter; and the fiscal tool kit developed by the within budget. To address this

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requirement, the applicant must notice in the Federal Register. The training and TA includes generalized describe— effect of each type of priority follows: presentations, products, and related (1) Clearly defined roles and Absolute priority: Under an absolute activities available through a website or responsibilities for at least two full-time priority, we consider only applications through brief contacts with the training key project personnel designated to the that meet the priority (34 CFR and technical assistance center staff. AIVRTTAC through the entire project 75.105(c)(3)). This document does not preclude us period and for consultants and Competitive preference priority: from proposing additional priorities, subcontractors, as applicable; Under a competitive preference priority, requirements, definitions, or selection (2) Timelines and milestones for we give competitive preference to an criteria, subject to meeting applicable accomplishing the project tasks; application by (1) awarding additional rulemaking requirements. (3) Using a personnel loading chart, points, depending on the extent to Note: This document does not solicit detailed project activities through the which the application meets the priority applications. In any year in which we entire project period, key personnel and (34 CFR 75.105(c)(2)(i)); or (2) selecting choose to use the priority and any consultants or subcontractors that an application that meets the priority definitions we invite applications will be allocated to each activity, and over an application of comparable merit through a notice in the Federal Register. that does not meet the priority (34 CFR the designated level of effort for each of Executive Orders 12866 and 13563 those activities; 75.105(c)(2)(ii)). Invitational priority: Under an (4) How the personnel allocations in Regulatory Impact Analysis invitational priority, we are particularly the personnel loading chart are interested in applications that meet the Under Executive Order 12866, OMB appropriate and adequate to achieve the priority. However, we do not give an must determine whether this regulatory project’s intended outcomes, including application that meets the priority a action is ‘‘significant’’ and, therefore, an assurance that all personnel will preference over other applications (34 subject to the requirements of the communicate with stakeholders and CFR 75.105(c)(1)). Executive order and subject to review by RSA in a timely way; Final Definitions: We establish the OMB. Section 3(f) of Executive Order (5) How the proposed management following definitions for use in any 12866 defines a ‘‘significant regulatory plan will ensure that the training and competition in which the final priority action’’ as an action likely to result in TA products developed through this is used: a rule that may— cooperative agreement are complete, Intensive training and technical (1) Have an annual effect on the accurate, and of high quality; and assistance (TA) means training and TA economy of $100 million or more, or (6) How the proposed project will provided to the governing bodies of adversely affect a sector of the economy, benefit from a diversity of perspectives, Indian Tribes that have received an productivity, competition, jobs, the including AIVRS projects and AIVRS grant and to the current environment, public health or safety, or consumers, State VR agencies, TA personnel of the AIVRS projects State, local, or Tribal governments or providers, and policy makers, in its primarily on-site over an extended communities in a material way (also development and operation; and period. Intensive training and TA is referred to as an ‘‘economically (f) Demonstrate in the narrative based on an ongoing relationship significant’’ rule); section of the application under between the training and TA center staff (2) Create serious inconsistency or ‘‘Quality of the Evaluation Plan’’ how and the governing bodies of Indian otherwise interfere with an action taken the applicant proposes to collect and Tribes that have received an AIVRS or planned by another agency; analyze data on specific and measurable grant and the current personnel of the (3) Materially alter the budgetary goals, objectives, and intended AIVRS projects under the terms of a impacts of entitlement grants, user fees, outcomes of the project, including the signed intensive training and TA or loan programs or the rights and effectiveness of the training and TA agreement. obligations of recipients thereof; or provided. To address this requirement, Targeted training and technical (4) Raise novel legal or policy issues the applicant must describe— assistance means training and TA based arising out of legal mandates, the (i) Its proposed evaluation on needs common to one or more President’s priorities, or the principles methodologies, including instruments, governing bodies of Indian Tribes that stated in the Executive order. data collection methods, and analyses; have received an AIVRS grant and to the This final regulatory action is not a (ii) Its proposed standards or targets current personnel of the AIVRS projects significant regulatory action subject to for determining effectiveness; on a time-limited basis and with limited review by OMB under section 3(f) of (iii) How it will use the evaluation commitment of training and technical Executive Order 12866. results to examine the effectiveness of assistance center resources. Targeted We have also reviewed this final its implementation and its progress training and TA are delivered through regulatory action under Executive Order toward achieving the intended virtual or in-person methods tailored to 13563, which supplements and outcomes; and the identified needs of the participating explicitly reaffirms the principles, (iv) How the methods of evaluation governing bodies of Indian Tribes that structures, and definitions governing will produce quantitative and have received an AIVRS grant and to the regulatory review established in qualitative data that demonstrate current personnel of the AIVRS projects. Executive Order 12866. To the extent whether the project and individual Universal training and technical permitted by law, Executive Order training and TA activities achieved their assistance means training and TA 13563 requires that an agency— intended outcomes. broadly available to governing bodies of (1) Propose or adopt regulations only Indian Tribes that have received an upon a reasoned determination that Types of Priorities AIVRS grant and to the current their benefits justify their costs When inviting applications for a personnel of the AIVRS projects and (recognizing that some benefits and competition using one or more other interested parties through their costs are difficult to quantify); priorities, we designate the type of each own initiative, resulting in minimal (2) Tailor its regulations to impose the priority as absolute, competitive interaction with training and technical least burden on society, consistent with preference, or invitational through a assistance center staff. Universal obtaining regulatory objectives and

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taking into account—among other things the VR process and practices and the www.govinfo.gov/fdsys. At this site you and to the extent practicable—the costs unique skills and knowledge necessary can view this document, as well as all of cumulative regulations; to improve employment outcomes for other documents of this Department (3) In choosing among alternative American Indians with disabilities. published in the Federal Register, in regulatory approaches, select those Intergovernmental Review: This text or Adobe Portable Document approaches that maximize net benefits program is not subject to Executive Format (PDF). To use PDF you must (including potential economic, Order 12372 and the regulations in 34 have Adobe Acrobat Reader, which is environmental, public health and safety, CFR part 79. available free at the site. and other advantages; distributive Regulatory Flexibility Act You may also access documents of the impacts; and equity); Certification: The Secretary certifies that Department published in the Federal (4) To the extent feasible, specify this regulatory action will not have a Register by using the article search performance objectives, rather than the significant economic impact on a feature at: www.federalregister.gov. behavior or manner of compliance a substantial number of small entities. Specifically, through the advanced regulated entity must adopt; and The U.S. Small Business Administration search feature at this site, you can limit (5) Identify and assess available Size Standards define proprietary your search to documents published by alternatives to direct regulation, institutions as small businesses if they the Department. including economic incentives—such as are independently owned and operated, user fees or marketable permits—to are not dominant in their field of David Cantrell, encourage the desired behavior, or operation, and have total annual Deputy Director, Office of Special Education provide information that enables the revenue below $7,000,000. Nonprofit Programs. Delegated the authority to perform public to make choices. institutions are defined as small entities the functions and duties of the Assistant Executive Order 13563 also requires if they are independently owned and Secretary for the Office of Special Education and Rehabilitative Services. an agency ‘‘to use the best available operated and not dominant in their field techniques to quantify anticipated of operation. Public institutions are [FR Doc. 2021–05430 Filed 3–11–21; 4:15 pm] present and future benefits and costs as defined as small organizations if they BILLING CODE 4000–01–P accurately as possible.’’ The Office of are operated by a government Information and Regulatory Affairs of overseeing a population below 50,000. OMB has emphasized that these The small entities that this regulatory DEPARTMENT OF COMMERCE techniques may include ‘‘identifying action will affect are public or private changing future compliance costs that nonprofit agencies and organizations, National Oceanic and Atmospheric might result from technological including Indian Tribes and institutions Administration innovation or anticipated behavioral of higher education that may apply. We changes.’’ believe that the costs imposed on an 50 CFR Part 660 We are issuing this final priority and applicant by the priority and definitions [Docket No. 210308–0049] definitions only on a reasoned will be limited to paperwork burden determination that their benefits justify related to preparing an application and RIN 0648–BJ74 their costs. In choosing among that the benefits of the priority and Magnuson-Stevens Act Provisions; alternative regulatory approaches, we definitions will outweigh any costs Fisheries Off West Coast States; selected those approaches that incurred by the applicant. There are Pacific Coast Groundfish Fishery; maximize net benefits. Based on the very few entities that could provide the 2021–2022 Biennial Specifications and analysis that follows, the Department type of training and TA required under Management Measures; Correction believes that this regulatory action is the final priority. For these reasons the consistent with the principles in priority and definitions will not impose AGENCY: National Marine Fisheries Executive Order 13563. a burden on a significant number of Service (NMFS), National Oceanic and We also have determined that this small entities. Atmospheric Administration (NOAA), regulatory action does not unduly Paperwork Reduction Act of 1995: Commerce. interfere with State, local, and Tribal The priority and definitions contain ACTION: Final rule; correcting governments in the exercise of their information collection requirements that amendment. governmental functions. are approved by OMB under OMB In accordance with these Executive control number 1820–0018; the priority SUMMARY: This action contains orders, the Department has assessed the and definitions do not affect the corrections to the final rule for the potential costs and benefits, both currently approved data collection. 2021–2022 Biennial Harvest quantitative and qualitative, of this Accessible Format: On request to the Specifications and Management regulatory action. The potential costs contact person listed under FOR FURTHER Measures for groundfish harvested in are those resulting from statutory INFORMATION CONTACT, individuals with the U.S. exclusive economic zone off the requirements and those we have disabilities can obtain this document in coasts of Washington, Oregon, and determined as necessary for an accessible format. The Department California published on December 11, administering the Department’s will provide the requestor with an 2020. This action corrects: the Rockfish programs and activities. The costs accessible format that may include Rich Conservation Area (RCA) waypoints for would include the time and effort in Text Format (RTF) or text format (txt), the 100 fathom depth contour, the other responding to the priority for entities a thumb drive, an MP3 file, Braille, large flatfish gear restrictions in the RCA, that choose to respond. print, audiotape, or compact disc, or language describing the boundary lines In addition, we have considered the other accessible format. for the depth contours, and the potential benefits of this regulatory Electronic Access to This Document: boundaries of the non-groundfish RCA action and have noted these benefits in The official version of this document is for California halibut, sea cucumber, the background section of this the document published in the Federal and ridgeback prawns south of 34°27′ N. document. The benefits include Register. You may access the official lat. These corrections are necessary so continuing to provide both TA and a edition of the Federal Register and the the regulations accurately implement structured training program focused on Code of Federal Regulations at the Pacific Fishery Management

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Council’s intent and are consistent with would revise the language in a previous action taken pursuant to what was anticipated by participants in § 660.360(3)(i)(A)(1) and (2) to include section 304(b), the Council designed the the groundfish fishery. the correct description of the depth Pacific Coast Groundfish Fishery DATES: This correction is effective contours consistent with the intent of Management Plan (FMP) to authorize March 16, 2021. the 2021–2022 harvest specifications NMFS to take this action pursuant to FOR FURTHER INFORMATION CONTACT: final rule and the Council’s intent. This MSA section 305(d). See 50 CFR 660. Karen Palmigiano at karen.palmigiano@ clarification is needed to provide The NMFS Assistant Administrator has noaa.gov or 206–526–4491. consistency among sections in the determined that this final rule is regulations so that the description of the consistent with the FMP and other SUPPLEMENTARY INFORMATION: NMFS depth contours for recreational closed published a final rule on December 11, applicable law. areas are consistent between the three 2020, (85 FR 79880), that implemented Pursuant to 5 U.S.C. 553(b)(B), the states. the 2021–2022 harvest specifications Assistant Administrator for Fisheries The final rule implemented the (AA) finds there is good cause to waive and management measures for Council recommendation to remove the groundfish harvested in the U.S. prior notice and an opportunity for gear restrictions for the limited-entry public comment on this action, as notice exclusive economic zone off the coasts fixed-gear (LEFG) and open-access (OA) of Washington, Oregon, and California. and comment would be unnecessary fishery targeting stocks in the ‘‘Other and contrary to public interest. Notice That final rule was effective January 1, Flatfish’’ complex south of 42° N lat. by 2021. After publication of the final rule, and comment are unnecessary and removing the hook-and-line gear contrary to the public interest because NMFS noted the need for four restriction language from the LEFG and corrections. this action corrects inadvertent errors OA trip limit tables. However, NMFS related to the December 11, 2020 final Corrections inadvertently did not remove the gear rule (85 FR 79880). Immediate restriction from other sections of the correction of the errors is necessary to The final rule for the 2021–2022 regulatory text. Specifically, the groundfish harvest specifications and prevent confusion among participants in requirement to use no more than 12 the fishery due to conflicting gear management measures (85 FR 79880; hooks, Number 2 or smaller, which December 11, 2020) inadvertently restrictions and lack of waypoints to measure no more than 11 mm (0.44 define boundary lines that could result deleted the final waypoint for the line inches) point to shank and up to two 1- approximating the 100-fathom depth in issues with enforcement. To lb (0.45 kg) weights per line should have effectively correct the errors, the contour coast-wide at the U.S. and been removed in all places it appears in changes in this action must be effective Mexico border. This waypoint, known the regulatory text and replaced with ° ′ upon publication as the fishery has as point #322, at 32 34.22 North hook and line gear only. This final rule ° ′ already begun. Thus, there is not latitude (N lat.), 117 21.20 West would remove the gear restriction sufficient time for notice and comment. longitude (W. long.) was part of the specifying the type and number of In addition, notice and comment is regulations in 2020 and the Pacific hooks from the regulations so that the unnecessary because this notice makes Fishery Management Council (Council) regulations are consistent and follow the only minor changes to correct did not recommend to remove it intent of the action. This correction is inadvertent errors related to the through the 2021–2022 harvest needed to reduce confusion and December 11, 2020 final rule (85 FR specifications. This final rule will add inconsistencies in the regulatory text as 79880). These corrections will not affect point #322 back into the list of to what gears are allowed to be used the results of analyses conducted to waypoints for the 100-fathom line. inside the non-trawl RCA. Without this point identified in the The final rule included a support management decisions in the regulations, it is difficult for members of typographical error in the description of Pacific Coast groundfish fishery. These industry to use their plotters to identify the boundary lines south of 34°27′ N lat. corrections are consistent with the the boundaries of the non-trawl RCA. for the non-groundfish trawl RCA for Council’s intent for regulations and the Additionally, the waypoint must be California halibut, sea cucumber, and public expects the regulations to be reinstated into the regulations in order ridgeback prawns in Table 3 (South) to written as in the correction. No change for law enforcement to correctly enforce Subpart F. Instead of stating the fathom in operating practices in the fishery is the boundaries of the non-trawl RCA. lines of the boundary, the boundaries required. This correcting amendment would are stated as 01/01/2021+A108:P133. For the same reasons stated above, the revise the regulations to reinstate the This final rule will correct the boundary AA has determined good cause exists to missing waypoint. from the 100 fm line to the 150 fm line. waive the 30-day delay in effectiveness In order to make the description of the This correction is needed to enforce the pursuant to 5 U.S.C. 553(d). This notice depth contours off of California boundaries of this non-groundfish trawl makes only minor corrections to the consistent with the description used for RCA and also to reduce confusion about final rule which was effective January 1, Oregon and Washington, the final rule the boundaries among members of 2021. Delaying effectiveness of these noted in section ‘‘V. Changes From the industry. corrections would result in conflicts in Proposed Rule’’ that the language All of these corrections are consistent the regulations and confusion among describing the boundary lines in with the Council action for the 2021– fishery participants. Because prior § 660.360(3)(i)(A)(1) and (2) would be 2022 groundfish harvest specifications notice and an opportunity for public changed from . . . is prohibited and the public expects the regulations to comment are not required to be seaward of the 30 fm (55m) depth be written as in the correction. These provided for this rule by 5 U.S.C. 553, contour . . . to . . . is prohibited are minor corrections to correctly or any other law, the analytical seaward of the boundary line implement the Council’s intent in their requirements of the Regulatory approximating the 30 fm (55m) depth final action taken in June 2020. Flexibility Act, 5 U.S.C. 601 et seq., are contour .... However, the final rule not applicable. Accordingly, no inadvertently did not change the Classification Regulatory Flexibility Analysis is regulatory text to include the updated NMFS is issuing this rule pursuant to required for this rule and none has been description. This correcting amendment 305(d) of the Magnuson-Stevens Act. In prepared.

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This final rule is not significant under (322) 32°34.22′ N lat., 117°21.20′ W (11) * * * Executive Order 12866. long. (iv) It is lawful to fish within the This final rule contains no * * * * * nontrawl RCA with limited entry fixed information collection requirements ■ 3. In § 660.230, revise paragraph (d) gear using hook and line gear only when under the Paperwork Reduction Act of introductory text, add paragraph trip limits authorize such fishing, and 1995. (d)(10)(i), and revise paragraphs provided a valid declaration report as required at § 660.13(d), subpart C, has List of Subjects in 50 CFR Part 660 (d)(11)(iv) and (d)(12) and (13) to read as follows: been filed with NMFS OLE. Fisheries, Fishing, and Indian (12) Farallon Islands. Under fisheries. § 660.230 Fixed gear fishery— California law, commercial fishing for management measures. Dated: March 10, 2021. all groundfish is prohibited between the * * * * * shoreline and the 10 fm (18 m) depth Samuel D. Rauch III, (d) Groundfish conservation areas. Deputy Assistant Administrator for contour around the Farallon Islands. An GCAs are defined by coordinates exception to this prohibition is that Regulatory Programs, National Marine expressed in degrees of latitude and commercial fishing for ‘‘other flatfish’’ Fisheries Service. longitude. The latitude and longitude is allowed around the Farallon Islands coordinates of the GCA boundaries are For the reasons set out in the using hook and line gear only. (See specified at §§ 660.70 through 660.74. A preamble, 50 CFR part 660 is corrected Table 2 (South) of this subpart.) For a vessel that is authorized by this by making the following correcting definition of the Farallon Islands, see paragraph to fish within a GCA (e.g., amendments: § 660.70, subpart C. fishing for ‘‘other flatfish’’ with hook PART 660—FISHERIES OFF WEST and line gear only), may not (13) Cordell Banks. Commercial COAST STATES simultaneously have other gear on board fishing for groundfish is prohibited in the vessel that is unlawful to use for waters of depths less than 100 fm (183 ■ 1. The authority citation for 50 CFR fishing within the GCA. The following m) around Cordell Banks, as defined by part 660 continues to read as follows: GCAs apply to vessels participating in specific latitude and longitude coordinates at § 660.70, subpart C. An Authority: 16 U.S.C. 1801 et seq., 16 U.S.C. the limited entry fixed gear fishery. exception to this prohibition is that 773 et seq., and 16 U.S.C. 7001 et seq. * * * * * commercial fishing for ‘‘other flatfish’’ ■ 2. In § 660.73, add paragraph (a)(322) (10) * * * (i) Fishing for ‘‘other flatfish’’ is is allowed around Cordell Banks using to read as follows: permitted within the CCAs with hook hook and line gear only. § 660.73 Latitude/longitude coordinates and line gear only; and provided a valid * * * * * defining the 100 fm (183 m) through 150 fm declaration report as required at ■ 4. Revise Table 2 (North) and Table 2 (274 m) depth contours. § 660.13(d), subpart C, has been filed (South) to part 660, subpart E, to read * * * * * with NMFS OLE. as follows: (a) * * * * * * * * BILLING CODE 3510–22–P

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BILLING CODE 3510–22–C may not simultaneously have other gear (12) * * * ■ 5. In § 660.330, revise paragraphs (d) on board the vessel that is unlawful to (iv) Fishing for ‘‘other flatfish’’ off introductory text, (d)(11)(i), (d)(12)(iv), use for fishing within the GCA. The California (between 42° N lat. south to and (d)(14) and (15) to read as follows: following GCAs apply to vessels the U.S./Mexico border) is allowed participating in the open access within the nontrawl RCA with hook and § 660.330 Open access fishery— groundfish fishery. management measures. line gear only; and provided a valid * * * * * * * * * * declaration report as required at § 660.13(d), has been filed with NMFS (d) Groundfish conservation areas (11) * * * OLE. (GCAs). GCAs, a type of closed area, are (i) Fishing for ‘‘other flatfish’’ is defined at § 660.11 and with latitude allowed within the CCAs with hook and * * * * * and longitude coordinates at §§ 660.70 line gear only; and provided a valid (14) Farallon Islands. Under through 660.74. A vessel that is declaration report as required at California law, commercial fishing for authorized by this paragraph to fish § 660.13(d), has been filed with NMFS all groundfish is prohibited between the within a GCA (e.g., fishing for ‘‘other OLE. shoreline and the 10 fm (18 m) depth flatfish’’ using hook and line gear only), * * * * * contour around the Farallon Islands. An

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exception to this prohibition is that (15) Cordell Banks. Commercial is allowed around Cordell Banks using commercial fishing for ‘‘other flatfish’’ fishing for groundfish is prohibited in hook and line gear only. is allowed around the Farallon Islands waters of depths less than 100-fm (183- * * * * * using hook and line gear only. (See m) around Cordell Banks, as defined by ■ Table 2 (South) of this subpart.) For a specific latitude and longitude 6. Revise Table 3 (North) and Table 3 definition of the Farallon Islands, see coordinates at § 660.70, subpart C. An (South) to part 660, subpart F, to read § 660.70, subpart C. exception to this prohibition is that as follows: commercial fishing for ‘‘other flatfish’’ BILLING CODE 3510–22–P

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■ 7. In § 660.360, revise paragraphs ‘‘Other Flatfish’’ as specified in starry flounder, and ‘‘Other Flatfish’’ as (c)(3)(i)(A)(1) and (2) to read as follows: paragraph (c)(3)(iv) of this section) is specified in paragraph (c)(3)(iv) of this closed from January 1 through April 30; section) is closed from January 1 § 660.360 Recreational fishery— is prohibited seaward of the boundary management measures. through April 30; prohibited seaward of line approximating the 30 fm (55 m) the boundary line approximating the 30 * * * * * depth contour along the mainland coast fm (55 m) depth contour along the (c) * * * and along islands and offshore mainland coast and along islands and (3) * * * seamounts from May 1 through October offshore seamounts from May 1 through (i) * * * 31 (shoreward of 30 fm is open); and is October 31 (shoreward of 30 fm is (A) * * * open at all depths from November 1 open), and is open at all depths from (1) Between 42° N lat. (California/ through December 31. November 1 through December 31. Oregon border) and 40°10′ N lat. (2) Between 40°10′ N lat. and (Northern Management Area), 38°57.50′ N lat. (Mendocino * * * * * recreational fishing for all groundfish Management Area), recreational fishing [FR Doc. 2021–05359 Filed 3–15–21; 8:45 am] (except petrale sole, starry flounder, and for all groundfish (except petrale sole, BILLING CODE 3510–22–C

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Proposed Rules Federal Register Vol. 86, No. 49

Tuesday, March 16, 2021

This section of the FEDERAL REGISTER Building Ground Floor, Washington, DC Operations in Room W12–140 of the contains notices to the public of the proposed 20590–0001. West Building Ground Floor at 1200 issuance of rules and regulations. The • Hand Delivery or Courier: Take New Jersey Avenue SE, Washington, purpose of these notices is to give interested comments to Docket Operations in DC, between 9 a.m. and 5 p.m., Monday persons an opportunity to participate in the Room W12–140 of the West Building through Friday, except Federal holidays. rule making prior to the adoption of the final rules. Ground Floor at 1200 New Jersey FOR FURTHER INFORMATION CONTACT: John Avenue SE, Washington, DC, between 9 Shelden, Human Machine Interface, a.m. and 5 p.m., Monday through AIR–626, Technical Innovation Policy DEPARTMENT OF TRANSPORTATION Friday, except Federal holidays. Branch, Policy and Innovation Division, • Fax: Fax comments to Docket Aircraft Certification Service, Federal Federal Aviation Administration Operations at 202–493–2251. Aviation Administration, 2200 South Privacy: Except for Confidential 216th Street, Des Moines, Washington 14 CFR Part 25 Business Information (CBI) as described 98198; telephone and fax 206–231– in the following paragraph, and other 3214; email [email protected]. [Docket No. FAA–2021–0228; Notice No. 25– information as described in 14 CFR SUPPLEMENTARY INFORMATION: The 21–01–SC] 11.35, the FAA will post all comments substance of these special conditions received without change, to http:// has been subject to the notice and Special Conditions: Haeco Cabin www.regulations.gov/, including any public comment procedure in several Solutions, Boeing Commercial personal information you provide. The prior instances. Additionally, a delay in Airplanes Model 737–800 Airplane; FAA will also post a report design approval would significantly Structure-Mounted Airbags summarizing each substantive verbal affect the applicant’s installation of the contact received about this proposal. AGENCY: system on the airplane. Therefore, the Federal Aviation Confidential Business Information: Administration (FAA), DOT. FAA is shortening the public comment Confidential Business Information (CBI) period to 30 days. ACTION: Notice of proposed special is commercial or financial information conditions. that is both customarily and actually Comments Invited treated as private by its owner. Under SUMMARY: This action proposes special The FAA invites interested people to the Freedom of Information Act (FOIA) conditions for the Boeing Commercial take part in this rulemaking by sending (5 U.S.C. 552), CBI is exempt from Airplanes (Boeing) Model 737–800 written comments, data, or views. The public disclosure. If your comments airplane. This airplane, as modified by most helpful comments reference a responsive to this Notice contain Haeco Cabin Solutions (Haeco), will specific portion of the special commercial or financial information have a novel or unusual design feature conditions, explain the reason for any that is customarily treated as private, when compared to the state of recommended change, and include that you actually treat as private, and technology envisioned in the supporting data. that is relevant or responsive to this airworthiness standards for transport The FAA will consider all comments Notice, it is important that you clearly category airplanes. This design feature received by the closing date for designate the submitted comments as is structure-mounted airbags designed to comments. The FAA may change these CBI. Please mark each page of your protect each occupant from serious head special conditions based on the submission containing CBI as injury in the event of an emergency comments received. ‘‘PROPIN.’’ The FAA will treat such landing. The applicable airworthiness marked submissions as confidential Background regulations do not contain adequate or under the FOIA, and the indicated appropriate safety standards for this On September 1, 2020, Haeco applied comments will not be placed in the design feature. These proposed special for a supplemental type certificate for public docket of this Notice. Send conditions contain the additional safety structure-mounted airbags in the Boeing submissions containing CBI to John standards that the Administrator Model 737–800 airplane. The Boeing Shelden, Human Machine Interface, considers necessary to establish a level Model 737–800 airplane, which is a AIR–626, Technical Innovation Policy of safety equivalent to that established derivative of the Boeing Model 737 Branch, Policy and Innovation Division, by the existing airworthiness standards. airplane currently approved under Type Aircraft Certification Service, Federal Certificate No. A16WE, is a twin-engine, DATES: Send comments on or before Aviation Administration, 2200 South transport-category airplane with seating April 15, 2021. 216th Street, Des Moines, Washington for 189 passengers and a maximum ADDRESSES: Send comments identified 98198; telephone and fax 206–231– takeoff weight of 174,200 pounds. by Docket No. FAA–2021–0228 using 3214; email [email protected]. any of the following methods: Comments the FAA receives, which are Type Certification Basis • Federal eRegulations Portal: Go to not specifically designated as CBI, will Under the provisions of title 14, Code http://www.regulations.gov/ and follow be placed in the public docket for this of Federal Regulations (14 CFR) 21.101, the online instructions for sending your rulemaking. Haeco must show that the Boeing Model comments electronically. Docket: Background documents or 737–800 airplane, as changed, continues • Mail: Send comments to Docket comments received may be read at to meet the applicable provisions of the Operations, M–30, U.S. Department of http://www.regulations.gov/ at any time. regulations listed in Type Certificate No. Transportation (DOT), 1200 New Jersey Follow the online instructions for A16WE or the applicable regulations in Avenue SE, Room W12–140, West accessing the docket or go to Docket effect on the date of application for the

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change, except for earlier amendments 1997. These special conditions establish a level of safety equivalent to as agreed upon by the FAA. supplemented 14 CFR part 25 and, more that established by the existing If the Administrator finds that the specifically, §§ 25.562 and 25.785. airworthiness standards. applicable airworthiness regulations The structure-mounted airbag, similar (e.g., 14 CFR part 25) do not contain to the inflatable lap belt, is designed to Applicability adequate or appropriate safety standards limit occupant forward excursion in the As discussed above, these special for the Boeing Model 737–800 airplane event of an emergency landing. These conditions are applicable to the Boeing because of a novel or unusual design airbags will reduce the potential for Model 737–800 airplane as modified by feature, special conditions are serious injury, including reducing the Haeco. Should Haeco apply at a later prescribed under the provisions of head-injury criterion measurement date for a supplemental type certificate § 21.16. defined in part 25. However, structure- to modify any other model included on Special conditions are initially mounted airbags function similarly as Type Certificate No. A16WE to applicable to the model for which they automotive airbags, where the airbag incorporate the same novel or unusual are issued. Should the applicant apply deploys from furniture located in front design feature, these special conditions for a supplemental type certificate to of the passenger, relative to the would apply to that model as well. modify any other model included on the airplane’s direction of flight, forming a Conclusion same type certificate to incorporate the barrier between the structure and same novel or unusual design feature, occupant. Also, unlike the inflatable lap This action affects only a certain these special conditions would also belt, the structure-mounted airbag does novel or unusual design features on one apply to the other model under § 21.101. not move with the occupant. To account model of airplane. It is not a rule of In addition to the applicable for out-of-position and brace-position general applicability and affects only airworthiness regulations and special occupants, the airbag is designed to the applicant who applied to the FAA conditions, the Boeing Model 737–800 conform to the curvature of the exposed for approval of these features on the airplane must comply with the fuel vent structure in the head-strike zone. airplane. Because the airbag system is and exhaust emission requirements of List of Subjects in 14 CFR Part 25 14 CFR part 34, and the noise essentially a single-use device, it could certification requirements of 14 CFR deploy under crash conditions that are Aircraft, Aviation safety, Reporting part 36. not sufficiently so severe as to require and recordkeeping requirements. the injury protection the airbag system The FAA issues special conditions, as Authority Citation defined in 14 CFR 11.19, in accordance provides. Because an actual crash is with § 11.38, and they become part of frequently composed of a series of The authority citation for these the type certification basis under impacts before the airplane comes to special conditions is as follows: § 21.101. rest, a larger impact following the initial Authority: 49 U.S.C. 106(f), 106(g), 40113, impact could render the airbag system 44701, 44702, 44704. Novel or Unusual Design Features unavailable. This potential situation The Boeing Model 737–800 airplane does not exist with standard upper-torso The Proposed Special Conditions will incorporate the following novel or restraints, which tend to provide Accordingly, the Federal Aviation unusual design features: continuous protection regardless of Administration (FAA) proposes the Airbags mounted to structure to impact severity, or number of impacts, following special conditions as part of prevent head injury. in a crash event. Therefore, the airbag the type certification basis for Boeing system installation should be such that Model 737–800 airplanes, as modified Discussion it provides protection, when it is by Haeco Cabin Solutions: Haeco proposes to install structure- required, by not expending its 1. The applicant must demonstrate by mounted airbags instead of inflatable protection when it is not required. If the test that the structure-mounted airbag lap belts as a means to protect each airbag deployment threshold is will deploy and provide protection occupant from serious injury in the unnecessarily low, the airbag would under crash conditions where it is event of an emergency landing, as need to continue to provide protection necessary to prevent serious injury to a required by § 25.562(c)(5), on 737–800 when an impact requiring protection 50th percentile occupant, as specified in airplanes. occurs. § 25.562. The means of protection must Such use of airbags to provide injury These proposed special conditions are provide a consistent approach to energy protection for the occupant is a novel or based upon Special Conditions 25–605– absorption for a range of occupants, unusual feature for this airplane model, SC for the Boeing Model 787–9 from a two-year-old child to a 95th and the applicable airworthiness airplanes equipped with B/E Aerospace percentile male. In addition, the regulations do not contain adequate or Super-Diamond model business-class following situations should be appropriate airworthiness standards for passenger seats and associated furniture. considered: these design features. Therefore, special Additionally, the special conditions • The seat occupant is holding an conditions are needed to address address protection of the occupant’s infant. requirements particular to installation of neck and spine for the structure- • The seat occupant is a child in a airbags in this manner. mounted airbag deployment. When child restraint device. Special conditions exist for airbags using the HIC15 head-injury method for • The seat occupant is a child not installed on seat belts, known as airbag impacts (calculated in accordance using a child restraint device. inflatable lap belts, which have been with 49 CFR 571.208) the neck and • The seat occupant is a pregnant installed on transport airplane spine limits are included as part of the woman. passenger seats. Structure-mounted allowance. These additional conditions airbags, although a novel design, were are based on special conditions issued a. Head-Injury Criteria first introduced on Jetstream Aircraft previously on oblique seats. The Compliance with § 25.562(c)(5) is Limited Model 4100 series airplanes, proposed special conditions contain the required, except that, if the ATD has no which resulted in issuance of Special additional safety standards that the apparent contact with the seat/structure Conditions 25–ANM–127 on May 14, Administrator considers necessary to but has contact with an airbag, a head-

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injury criterion (HIC) unlimited score in Compliance with Seat Dynamic Testing for the passenger seat for which the excess of 1000 is acceptable, provided for Plinths and Pallets,’’ dated February airbag is installed), possibility of impact the HIC15 score (calculated in 2, 2000, is acceptable to the FAA. on emergency evacuation (e.g., hanging accordance with 49 CFR 571.208) for 2. The structure-mounted airbag must in the aisle, potential trip hazard, etc.) that contact is less than 700. provide adequate protection for each must be evaluated. occupant regardless of the number of 12. The airbag electronic system must b. Body-to-Wall/Furnishing Contact occupants of the seat assembly. be designed to be protected from If a seat is installed aft of structure 3. The structure-mounted airbag lightning per § 25.1316(b), and high- (e.g., an interior wall or furnishing) that system must not be susceptible to intensity radiated fields per does not provide a homogenous contact inadvertent deployment as a result of § 25.1317(c). surface for the expected range of wear and tear, or inertial loads resulting 13. The structure-mounted airbag occupants and yaw angles, then from in-flight or ground maneuvers system must not contain or release additional analysis or tests may be (including gusts and hard landings) hazardous quantities of gas or required to demonstrate that the injury likely to be experienced in service. particulate matter into the cabin. criteria are met for the area that an 4. The applicant must demonstrate 14. The structure-mounted airbag occupant could contact. For example, if that an inadvertent deployment that installation must be protected from the different yaw angles could result in could cause injury to a standing or effects of fire such that no hazard to different airbag performance, then sitting person is improbable. Inadvertent occupants will result. additional analysis or separate tests may deployment must not cause injury to 15. The inflatable bag material must be necessary to evaluate performance. anyone who may be positioned close to meet the 2.5-inches-per-minute the structure-mounted airbag (e.g., horizontal flammability test defined in c. Neck-Injury Criteria seated in an adjacent seat, or standing 14 CFR part 25, appendix F, part I, The seating system must protect the adjacent to the airbag installation or the paragraph (a)(1)(iv). occupant from experiencing serious subject seat). Cases where a structure- 16. The design of the structure- neck injury. The assessment of neck mounted airbag is inadvertently mounted airbag system must protect the injury must be conducted with the deployed near a seated occupant or an mechanisms and controls from external airbag device activated, unless there is empty seat must be considered. contamination associated with that reason to also consider that the neck- 5. Inadvertent deployment of the which could occur on or around injury potential would be higher for structure-mounted airbag during the passenger seating. impacts below the airbag-device most critical part of flight will either not 17. The structure-mounted airbag deployment threshold. cause a hazard to the airplane or is system must have a means to verify the (1) The Nij (calculated in accordance extremely improbable. integrity of the structure-mounted airbag with 49 CFR 571.208) must be below 6. Deployment of the structure- activation system. 1.0, where Nij = Fz/Fzc + My/Myc, and Nij mounted airbag must not introduce 18. The applicant must provide critical values are: hazards or injury mechanisms to the installation limitations to ensure (a) Fzc = 1,530 lb for tension seated occupant, including occupants in installation compatibility between the (b) Fzc = 1,385 lb for compression the brace position. Deployment of the seat design and opposing monument or (c) Myc = 229 lb-ft in flexion structure-mounted airbag must also not structure. (d) Myc = 100 lb-ft in extension result in injuries that could impede Issued in City, MO, on March 10, (2) In addition, peak Fz must be below rapid exit from the airplane. 2021. 937 lb in tension and 899 lb in 7. Effects of the deflection and Patrick R. Mullen, compression. deformation of the structure to which (3) Rotation of the head about its the airbag is attached must be taken into Manager, Technical Innovation Policy vertical axis, relative to the torso, is account when evaluating deployment Branch, Policy and Innovation Division, Aircraft Certification Service. limited to 105 degrees in either and location of the inflated airbag. The direction from forward-facing. effect of loads imposed by airbag [FR Doc. 2021–05331 Filed 3–15–21; 8:45 am] (4) The neck must not impact any deployment, or stowed components BILLING CODE 4910–13–P surface that would produce where applicable, must also be taken concentrated loading on the neck. into account. 8. The applicant must demonstrate DEPARTMENT OF HOMELAND d. ATD and Test Conditions that the structure-mounted airbag, when SECURITY Longitudinal tests conducted to deployed, does not impair access to the measure the injury criteria above must seatbelt- or harness-release means, and Coast Guard be performed with the FAA Hybrid III must not hinder evacuation. This will ATD, as described in SAE 1999–01– include consideration of adjacent seat 33 CFR Part 165 1609, ‘‘A Lumbar Spine Modification to places and the aisle. [Docket Number USCG–2021–0115] the Hybrid III ATD for Aircraft Seat 9. The airbag, once deployed, must Tests.’’ The tests must be conducted not adversely affect the emergency- RIN 1625–AA87 with an undeformed floor, at the most- lighting system, and must not block Security Zone; North Atlantic Ocean, critical yaw cases for injury, and with escape-path lighting to the extent that Approaches to Ocean City, MD all lateral structural supports (e.g. the light(s) no longer meet their armrests or walls) installed. intended function. AGENCY: Coast Guard, DHS. Note: Applicant must demonstrate 10. The structure-mounted airbag ACTION: Notice of proposed rulemaking. that the installation of seats via plinths must not impede occupants’ rapid exit or pallets meets all applicable from the airplane 10 seconds after its SUMMARY: The Coast Guard is proposing requirements. Compliance with the deployment. to establish a temporary security zone guidance contained in policy 11. Where structure-mounted airbag encompassing certain waters of the memorandum PS–ANM–100–2000– systems are installed in or close to North Atlantic Ocean. The security zone 00123, ‘‘Guidance for Demonstrating passenger evacuation routes (other than is necessary to prevent waterside threats

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before, during and after National enter the zone, they must not enter Below we summarize our analyses Geospatial-Intelligence Agency waters within 1,000 yards of the on based on a number of these statutes and equipment testing conducted offshore scene Coast Guard vessel or test Executive orders, and we discuss First near Ocean City, MD, from April 25, equipment being used by Coast Guard Amendment rights of protestors. personnel. The Coast Guard is 2021, through May 8, 2021. Entry of A. Regulatory Planning and Review vessels or persons into this zone is proposing this rulemaking under prohibited unless specifically authority in 46 U.S.C. 70034 (previously Executive Orders 12866 and 13563 authorized by the Captain of the Port 33 U.S.C. 1232). direct agencies to assess the costs and benefits of available regulatory Maryland-National Capital Region or his III. Discussion of Proposed Rule designated representative. We invite alternatives and, if regulation is your comments on this proposed The COTP is proposing to establish a necessary, to select regulatory rulemaking. security zone from 9 a.m. on April 25, approaches that maximize net benefits. 2021, through 10 p.m. on May 8, 2021. This NPRM has not been designated a DATES: Comments and related material The security zone will be enforced from ‘‘significant regulatory action,’’ under must be received by the Coast Guard on 9 a.m. to 10 p.m. on April 25, 2021, and Executive Order 12866. Accordingly, or before April 15, 2021. those same hours on April 26, 2021, the NPRM has not been reviewed by the ADDRESSES: You may submit comments April 27, 2021, April 28, 2021, April 29, Office of Management and Budget identified by docket number USCG– 2021, April 30, 2021, May 1, 2021, May (OMB). 2021–0115 using the Federal 2, 2021, May 3, 2021, May 4, 2021, May This regulatory action determination eRulemaking Portal at https:// 5, 2021, May 6, 2021, May 7, 2021 and is based on location and duration of the www.regulations.gov. See the ‘‘Public May 8, 2021. The security zone will security zone. This security zone will be Participation and Request for cover all waters of the North Atlantic enforced 182 hours over the course of a Comments’’ portion of the Ocean, from surface to bottom, two week period. Vessels will be able to SUPPLEMENTARY INFORMATION section for encompassed by a line connecting the safely transit around the security zone, further instructions on submitting following points beginning at 38°23′56″ which impacts a small area of the North comments. N, 074°48′06″ W, thence south to Atlantic Ocean, where vessel traffic is ° ′ ″ ° ′ ″ FOR FURTHER INFORMATION CONTACT: 38 21 40 N, 074 48 33 W, thence south normally low. Additionally, the Coast If ° ′ ″ ° ′ ″ you have questions about this proposed to 38 17 54 N, 074 49 57 W, thence Guard will make notifications to the southwest to 38°15′04″ N, 074°51′44″ W, maritime community via marine rulemaking, call or email LCDR Samuel ° ′ ″ M. Danus, Waterways Management thence northwest to 38 18 52 N, information broadcasts. The Coast 074°54′24″ W, thence north to 38°22′55″ Guard will update such notifications as Division, U.S. Coast Guard; 410–576– ° ′ ″ 2519, [email protected]. N, 074 52 44 W, and northeast back to necessary to keep the maritime the beginning point. The zone is SUPPLEMENTARY INFORMATION: community informed of the status of the approximately 9.3 nautical miles in security zone. I. Table of Abbreviations length and 3.6 nautical miles in width. If a person or vessel has been granted B. Impact on Small Entities CFR Code of Federal Regulations The Regulatory Flexibility Act of COTP Captain of the Port permission to enter the zone, they must DHS Department of Homeland Security not enter waters within 1,000 yards of 1980, 5 U.S.C. 601–612, as amended, FR Federal Register the on scene Coast Guard vessel or test requires Federal agencies to consider NPRM Notice of proposed rulemaking equipment being used by Coast Guard the potential impact of regulations on § Section personnel. small entities during rulemaking. The U.S.C. United States Code The duration of the rule and term ‘‘small entities’’ comprises small enforcement of the zone is intended to II. Background, Purpose, and Legal businesses, not-for-profit organizations protect personnel, vessels, and the Basis that are independently owned and marine environment in these navigable operated and are not dominant in their On February 17, 2021, the National waters while the Coast Guard vessel and fields, and governmental jurisdictions Geospatial-Intelligence Agency (NGA) test equipment are being used. All with populations of less than 50,000. notified the Coast Guard that it will be vessels and persons must obtain The Coast Guard certifies under 5 U.S.C. conducting U.S. Government training permission from the COTP Maryland- 605(b) that this proposed rule would not and systems testing from 9 a.m. on April National Capital Region or his have a significant economic impact on 25, 2021, through 10 p.m. on May 8, designated representative before a substantial number of small entities. 2021. The training and testing will take entering the security zone. Equipment While some owners or operators of place in two locations offshore of Ocean testing operations may occur anywhere vessels intending to transit the security City, MD. The COTP Maryland-National within the security zone during the zone may be small entities, for the Capital Region has determined that a enforcement periods. Vessels and reasons stated in section IV.A above, security zone is needed for waterborne persons will not be permitted to enter this proposed rule would not have a protection of the public, mitigation of the security zone within 1,000 yards of significant economic impact on any potential terrorist acts, and the the Coast Guard vessel or test vessel owner or operator. enhancing of public and maritime safety equipment. While this 1,000 yards area If you think that your business, and security in order to safeguard life, lies within the security zone, its exact organization, or governmental property, and the environment on or location within the security zone may jurisdiction qualifies as a small entity near the navigable waters near Ocean change. The regulatory text we are and that this rule would have a City, MD. proposing appears at the end of this significant economic impact on it, The purpose of this rulemaking is to document. please submit a comment (see ensure the security of vessels and ADDRESSES) explaining why you think it government equipment involved in this IV. Regulatory Analyses qualifies and how and to what degree event by prohibiting vessels from We developed this proposed rule after this rule would economically affect it. entering the security zone. If a person or considering numerous statutes and Under section 213(a) of the Small vessel has been granted permission to Executive orders related to rulemaking. Business Regulatory Enforcement

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Fairness Act of 1996 (Pub. L. 104–121), F. Environment We accept anonymous comments. we want to assist small entities in We have analyzed this proposed rule Comments we post to https:// understanding this proposed rule. If the under Department of Homeland www.regulations.gov will include any rule would affect your small business, Security Directive 023–01, Rev. 1, personal information you have organization, or governmental associated implementing instructions, provided. For more about privacy and jurisdiction and you have questions and Environmental Planning submissions in response to this concerning its provisions or options for COMDTINST 5090.1 (series), which document, see DHS’s eRulemaking compliance, please call or email the guide the Coast Guard in complying System of Records notice (85 FR 14226, person listed in the FOR FURTHER with the National Environmental Policy March 11, 2020). INFORMATION CONTACT section. The Coast Act of 1969 (42 U.S.C. 4321–4370f), and Documents mentioned in this NPRM Guard will not retaliate against small have made a preliminary determination as being available in the docket, and entities that question or complain about that this action is one of a category of public comments, will be in our online this proposed rule or any policy or actions that do not individually or docket at https://www.regulations.gov action of the Coast Guard. cumulatively have a significant effect on and can be viewed by following that C. Collection of Information the human environment. This proposed website’s instructions. We review all rule involves a security zone lasting comments received, but we will only This proposed rule would not call for post comments that address the topic of a new collection of information under only 182 total enforcement hours that will prohibit entry within a small the proposed rule. We may choose not the Paperwork Reduction Act of 1995 to post off-topic, inappropriate, or (44 U.S.C. 3501–3520). portion of the North Atlantic Ocean. Normally such actions are categorically duplicate comments that we receive. If D. Federalism and Indian Tribal excluded from further review under you go to the online docket and sign up Governments paragraph L60(a) of Appendix A, Table for email alerts, you will be notified A rule has implications for federalism 1 of DHS Instruction Manual 023–01– when comments are posted or a final under Executive Order 13132 001–01, Rev. 1. A preliminary Record of rule is published. (Federalism), if it has a substantial Environmental Consideration List of Subjects in 33 CFR Part 165 direct effect on the States, on the supporting this determination is relationship between the National available in the docket. For instructions Harbors, Marine safety, Navigation Government and the States, or on the on locating the docket, see the (water), Reporting and recordkeeping distribution of power and ADDRESSES section of this preamble. We requirements, Security measures, responsibilities among the various seek any comments or information that Waterways. levels of government. We have analyzed may lead to the discovery of a For the reasons discussed in the this proposed rule under that Order and significant environmental impact from preamble, the Coast Guard is proposing have determined that it is consistent this proposed rule. to amend 33 CFR part 165 as follows: with the fundamental federalism G. Protest Activities principles and preemption requirements PART 165—REGULATED NAVIGATION described in Executive Order 13132. The Coast Guard respects the First AREAS AND LIMITED ACCESS AREAS Amendment rights of protesters. Also, this proposed rule does not have ■ tribal implications under Executive Protesters are asked to call or email the 1. The authority citation for part 165 Order 13175 (Consultation and person listed in the FOR FURTHER continues to read as follows: Coordination with Indian Tribal INFORMATION CONTACT section to Authority: 46 U.S.C. 70034, 70051; 33 CFR Governments) because it would not coordinate protest activities so that your 1.05–1, 6.04–1, 6.04–6, and 160.5; have a substantial direct effect on one or message can be received without Department of Homeland Security Delegation more Indian tribes, on the relationship jeopardizing the safety or security of No. 0170.1. between the Federal Government and people, places, or vessels. ■ 2. Add § 165.T05–0115 to read as Indian tribes, or on the distribution of V. Public Participation and Request for follows: power and responsibilities between the Comments Federal Government and Indian tribes. § 165.T05–0115 Security Zone; North We view public participation as Atlantic Ocean, Approaches to Ocean City, If you believe this proposed rule has MD. implications for federalism or Indian essential to effective rulemaking, and tribes, please call or email the person will consider all comments and material (a) Location. The following is a listed in the FOR FURTHER INFORMATION received during the comment period. security zone: All waters of the North CONTACT section. Your comment can help shape the Atlantic Ocean, from surface to bottom, outcome of this rulemaking. If you encompassed by a line connecting the E. Unfunded Mandates Reform Act submit a comment, please include the following points beginning at 38°23′56″ The Unfunded Mandates Reform Act docket number for this rulemaking, N, 074°48′06″ W, thence south to of 1995 (2 U.S.C. 1531–1538) requires indicate the specific section of this 38°21′40″ N, 074°48′33″ W, thence south Federal agencies to assess the effects of document to which each comment to 38°17′54″ N, 074°49′57″ W, thence their discretionary regulatory actions. In applies, and provide a reason for each southwest to 38°15′04″ N, 074°51′44″ W, particular, the Act addresses actions suggestion or recommendation. thence northwest to 38°18′52″ N, that may result in the expenditure by a We encourage you to submit 074°54′24″ W, thence north to 38°22′55″ State, local, or tribal government, in the comments through the Federal N, 074°52′44″ W, and northeast back to aggregate, or by the private sector of eRulemaking Portal at https:// the beginning point. All coordinates are $100,000,000 (adjusted for inflation) or www.regulations.gov. If your material based on datum NAD 83. more in any one year. Though this cannot be submitted using https:// (b) Definitions. As used in this proposed rule would not result in such www.regulations.gov, call or email the section— an expenditure, we do discuss the person in the FOR FURTHER INFORMATION Captain of the Port (COTP) means the effects of this rule elsewhere in this CONTACT section of this document for Commander, U.S. Coast Guard Sector preamble. alternate instructions. Maryland-National Capital Region.

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Designated representative means the the federal implementation plan (FIP) I. Background Coast Guard commissioned, warrant, or that regulates emissions from the Navajo A. Action petty officer operating the on scene Generating Station (NGS), a coal-fired Coast Guard vessel designated by or power plant that was located on the In this action, the EPA is proposing to assisting the Captain of the Port reservation lands of the Navajo Nation rescind the FIP for NGS that we Maryland-National Capital Region near Page, Arizona. NGS permanently promulgated on October 3, 1991 (‘‘1991 (COTP) in the enforcement of the ceased operations on November 18, FIP’’), March 5, 2010 (‘‘2010 FIP’’), and security zone. 2019, and the Clean Air Act (CAA or August 8, 2014 (‘‘2014 FIP’’).1 The (c) Regulations. (1) Under the general ‘‘Act’’) operating permit for this facility provisions of the 1991 action are security zone regulations in subpart D of has expired. codified in the Code of Federal Regulations (CFR) at 40 CFR 52.145(d), this part, you may not enter the security DATES: Any comments on this proposal the provisions of the 2010 action are zone described in paragraph (a) of this must arrive by April 15, 2021. section unless authorized by the COTP codified at 40 CFR 49.5513(a) through or the COTP’s designated representative. ADDRESSES: Submit your comments, (i), and provisions of the 2014 action are (2) To seek permission to enter the identified by Docket ID number EPA– codified at 40 CFR 49.5513(j). We refer security zone described in paragraph (a) R09–OAR–2021–0018, at http:// collectively to the provisions from the of this section, contact the COTP or the www.regulations.gov. For comments 1991, 2010, and 2014 actions as the COTP’s representative by telephone at submitted at Regulations.gov, follow the ‘‘FIP’’ or the ‘‘NGS FIP.’’ The NGS FIP 410–576–2693 or on Marine Band Radio online instructions for submitting includes federally enforceable emissions VHF–FM channel 16 (156.8 MHz). The comments. Once submitted, comments limitations that apply to the fossil fuel- Coast Guard vessel enforcing this cannot be edited or removed from fired steam generating equipment, section can be contacted on Marine Regulations.gov. The EPA may publish designated as Units 1, 2, and 3, Band Radio VHF–FM channel 16 (156.8 any comment received to its public equipment associated with the coal and MHz). Those in the security zone must docket. Do not submit electronically any ash handling, and the two auxiliary comply with all lawful orders or information you consider to be steam boilers at NGS. These emissions directions given to them by the COTP or Confidential Business Information (CBI) limitations apply to emissions of the COTP’s designated representative. or other information whose disclosure is particulate matter (PM), sulfur dioxide (3) A person or vessel operating in the restricted by statute. Multimedia (SO2), and oxides of nitrogen (NOX), and security zone described in paragraph submissions (audio, video, etc.) must be opacity. The EPA is proposing to rescind the NGS FIP and remove the (a)(1) of this section must not enter accompanied by a written comment. provisions of the FIP from 40 CFR waters within 1,000 yards of the on The written comment is considered the 52.145(d) and 40 CFR 49.5513. scene Coast Guard vessel or test official comment and should include equipment being used by Coast Guard discussion of all points you wish to B. Facility make. The EPA will generally not personnel. NGS was a coal-fired power plant that (d) Enforcement periods. This section consider comments or comment contents located outside of the primary ceased operation in 2019, located on the will be enforced 9 a.m. to 10 p.m. on reservation lands of the Navajo Nation, April 25, 2021, and those same hours on submission (i.e., on the web, cloud, or other file sharing system). For just east of Page, Arizona, and April 26, 2021, April 27, 2021, April 28, approximately 135 miles north of 2021, April 29, 2021, April 30, 2021, additional submission methods, or if you need assistance in a language other Flagstaff. NGS was co-owned by several May 1, 2021, May 2, 2021, May 3, 2021, entities and operated by Salt River May 4, 2021, May 5, 2021, May 6, 2021, than English or if you are a person with disabilities who needs a reasonable Project Agricultural Improvement and May 7, 2021 and May 8, 2021. 2 accommodation at no cost to you, please Power District (‘‘SRP’’). The facility Dated: March 9, 2021. contact the person identified in the FOR operated three units, each with a Joseph B. Loring, FURTHER INFORMATION CONTACT section. capacity of 750 megawatts (MW) net Captain, U.S. Coast Guard, Captain of the For the full EPA public comment policy, generation, with a total capacity of 2250 Port Maryland-National Capital Region. information about CBI or multimedia MW. Operations at the facility produced [FR Doc. 2021–05391 Filed 3–15–21; 8:45 am] submissions, and general guidance on air pollutant emissions, including emissions of SO2, NOX, and PM. BILLING CODE 9110–04–P making effective comments, please visit https://www.epa.gov/dockets/ Existing pollution control equipment at commenting-epa-dockets. NGS included wet flue gas desulfurization units for SO and PM ENVIRONMENTAL PROTECTION 2 FOR FURTHER INFORMATION CONTACT: removal, electrostatic precipitators for AGENCY Anita Lee, EPA Region IX, (415) 972– PM removal, and low-NOX burners with 3958, [email protected]. 40 CFR Parts 49 and 52 separated over-fire air to reduce NOX SUPPLEMENTARY INFORMATION: formation during the combustion [EPA–R09–OAR–2021–0018; FRL–10020– Throughout this document, ‘‘we,’’ ‘‘us,’’ process. Had the facility not ceased 02–Region 9] and ‘‘our’’ refer to the EPA. operations, the owner or operator of NGS would have taken steps by Rescission of the Source-Specific Table of Contents December 31, 2019 to reduce emissions Federal Implementation Plan for I. Background Navajo Generating Station, Navajo A. Action 1 56 FR 50172 (October 3, 1991), 75 FR 10174 Nation B. Facility (March 5, 2010), and 79 FR 46552 (August 8, 2014). C. Attainment Status 2 The original participants in NGS were the AGENCY: Environmental Protection D. The EPA’s Authority To Promulgate a United States Bureau of Reclamation, SRP, Arizona Agency (EPA). FIP in Indian Country Public Service Company, Tucson Electric Company, NV Energy, and the Los Angeles Department of ACTION : Proposed rule. E. Historical Overview of NGS FIP Actions Water and Power (LADWP). SRP, serves as the II. Basis for Proposed Action facility operator. Prior to the permanent closure of SUMMARY: The Environmental Protection III. Solicitation of Comments NGS, SRP acquired the LADWP participant share in Agency (EPA) is proposing to rescind IV. Statutory and Executive Order Reviews NGS.

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of NOX further, pursuant to the completeness criteria of 40 CFR part 51, emission limitations that Arizona had requirements of the 2014 FIP. Appendix V, or does not receive EPA erroneously included in its SIP.16 The approval of a submitted tribal EPA received comments on the C. Attainment Status implementation plan.’’ 9 proposed FIP but did not finalize the The area around NGS is designated proposal. attainment, unclassifiable/attainment, or E. Historical Overview of NGS FIP The EPA published a new proposed unclassifiable for all criteria pollutants Actions rule to promulgate federally enforceable under the Act.3 On December 2, 1980, EPA issued numerical emissions limitations for PM regulations addressing visibility D. The EPA’s Authority To Promulgate and SO2 in 2006 and took action to impairment that is traceable or 17 a FIP in Indian Country finalize it in 2010. The 2010 FIP also ‘‘reasonably attributable’’ to a single established an opacity limit and a When the CAA was amended in 1990, source or small group of sources.10 requirement for specific control Congress included a new provision, These regulations required a number of measures to limit dust emissions. In the section 301(d), granting the EPA states to submit SIPs no later than 2010 FIP, the EPA determined that the authority to treat tribes in the same September 2, 1981. Most states, emissions limitations for PM and SO2 manner as states where appropriate.4 In including Arizona, failed to submit SIPs were more stringent than, or at least as 1998, the EPA promulgated regulations as called for by the regulations. stringent as, the emissions limitations known as the Tribal Authority Rule Accordingly, in 1987, the EPA issued that had historically applied at NGS (TAR).5 The EPA’s promulgation of the visibility FIPs consisting of general plan pursuant to an operating permit issued TAR clarified, among other things, that requirements and long-term strategies by Arizona. Therefore, the EPA state air quality regulations generally do for 29 states including Arizona.11 concluded that air quality in this area not, under the CAA, apply to facilities In 1989, based on a report submitted would be positively impacted by the located anywhere within the exterior by the National Park Service, the EPA 2010 FIP.18 boundaries of Indian reservations.6 Prior proposed to find that a portion of the On August 8, 2014, the EPA to the addition of section 301(d) and the visibility impairment in Grand Canyon promulgated a final rule that established promulgation of the TAR, some states National Park was reasonably emissions limitations for NOX emissions had included emission limitations in attributable to NGS.12 Under the 1991 from NGS under BART provisions of the their state implementation plans (SIPs) FIP, NGS was required to phase-in Regional Haze Rule.19 We finalized an that they may have believed could apply compliance with the SO2 emissions alternative to BART based on agreed- under the CAA to private facilities limit by installing scrubbers in 1997, upon recommendations developed by a operating on adjacent Indian 1998, and 1999.13 In establishing the group of diverse stakeholders. The 2014 reservations. SO2 emissions limit for NGS in the final FIP limited emissions of NOX from NGS In the preambles to the proposed and 1991 FIP, the EPA determined that the by establishing a long-term facility-wide final 1998 TAR, the EPA generally FIP would provide for greater cap on total NOX emissions from 2009 discussed the legal basis in the CAA reasonable progress toward the national to 2044 and required the that authorizes the EPA to regulate visibility goal than implementation of implementation of one of several sources of air pollution in Indian best available retrofit technology alternative operating scenarios to ensure 7 country. The EPA concluded that the (BART).14 that the 2009 to 2044 cap was met. CAA authorizes the EPA to protect air On September 8, 1999, the EPA quality throughout Indian country.8 The proposed a source-specific FIP for II. Basis for Proposed Action TAR, therefore, provides that the EPA NGS.15 The 1999 proposed FIP stated: In 2017, due to the changing ‘‘[s]hall promulgate without ‘‘Although the facility has been economics of the energy industry, the unreasonable delay such federal historically regulated by Arizona since owners of NGS voted to permanently implementation plan provisions as are its construction, the state lacks close the facility at the end of 2019.20 necessary or appropriate to protect air jurisdiction over the facility or its On November 27, 2019, consistent with quality, consistent with the provisions owners or operations for CAA the reporting requirements in the of sections [301](a) and 301(d)(4), if a compliance or enforcement purposes.’’ alternative to BART provisions of the tribe does not submit a tribal The EPA intended for the proposed NGS FIP, SRP notified the EPA that it implementation plan meeting the action in 1999 to ‘‘federalize’’ the would not implement any of the BART alternatives in the FIP due to the 3 40 CFR 81.303. 9 63 FR 7273, codified at 40 CFR 49.11(a). In the permanent cessation of operations at 4 40 U.S.C. 7601(d). preamble to the final TAR, the EPA explained that NGS.21 In that letter, SRP noted that 5 40 CFR parts 9, 35, 49, 50, and 81. See also 63 it was inappropriate to treat tribes in the same FR 7254 (February 12, 1998). manner as states with respect to section 110(c) of Unit 3 permanently ceased operations 6 63 FR 7254 at 7258 (noting that unless a state the Act, which directs the EPA to promulgate a FIP on September 19, 2019, and that Units has explicitly demonstrated its authority and has within 2 years after the EPA finds a state has failed 1 and 2 permanently ceased operations been expressly approved by the EPA to implement to submit a complete state plan or within 2 years on November 18, 2019. This closure CAA programs in Indian country, the EPA is the after the EPA disapproval of a state plan. Although appropriate entity to implement CAA programs the EPA is not required to promulgate a FIP within 16 prior to tribal primacy), Arizona Public Service the 2-year period for tribes, the EPA promulgated 64 FR 48725, 48727. Company v. EPA., 211 F.3d 1280 (D.C. Cir. 2000), 40 CFR 49.11(a) to clarify that the EPA will 17 75 FR 10179 (March 5, 2010) codified at 40 CFR cert. denied sub nom, v. EPA., 532 U.S. continue to be subject to the basic requirement to 49.24(a) through (i) and redesignated to 40 CFR issue any necessary or appropriate FIP provisions 970 (2001) (upholding the TAR); see also Alaska v. 49.5513(a) through (i). See 76 FR 23879 (April 29, for affected tribal areas within some reasonable Native Village of Venetie Tribal Government, 533 2011). time. See 63 FR 7264–65. U.S. 520, 526 n.1 (1998) (primary jurisdiction over 18 75 FR 10174 (March 5, 2010). 10 Indian country generally lies with federal 45 FR 80084 (December 2, 1980), codified at 40 19 79 FR 46514 (August 8, 2014). CFR 51.300–51.307. government and tribes, not with states). 20 https://www.powermag.com/utility-owners- 11 7 59 FR 43956 (August 25, 1994); 63 FR 7253 52 FR 45132 (November 24, 1987). vote-to-shut-down-coal-fired-2-2-gw-navajo- (February 12, 1998). 12 56 FR 50172 (October 3, 1991), codified at 40 generating-station/. 8 63 FR 7253 at 7262 (February 12, 1998); 59 FR CFR 52.145. 21 Letter dated November 27, 2019, from Kenneth 43956 at 43960–43961 (August 25, 1994) (citing, 13 40 CFR 52.145(d)(7). Joe Frazier, SRP, to Elizabeth Adams, EPA, among other things, to CAA sections 101(b)(1), 14 56 FR 50172 (October 3, 1991). regarding ‘‘Navajo Generating Station—Notification 301(a), and 301(d)). 15 64 FR 48725 (September 8, 1999). of BART Alternative.’’

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timeframe was consistent with the terms closed, and the dedicated rail line needed to satisfy requirements of the NGS Extension Lease agreement linking the mine to NGS has been concerning attainment or reasonable between the Navajo Nation and the dismantled. In addition, the three 775- further progress. Therefore, we propose owners of NGS prohibiting the foot stacks at NGS have been to find that rescission of the 1991 FIP combustion of coal at NGS after demolished.26 will not interfere with any applicable December 22, 2019. After November 18, Because NGS has permanently ceased CAA requirements. 2019, the owners and operator of NGS operation and all equipment subject to The provisions of the 2010 FIP at 40 began decommissioning the facility. On the NGS FIP is no longer operational, CFR 49.5513(a) through (i) apply to November 30, 2020, SRP withdrew its and because the facility no longer holds Units 1, 2, and 3, equipment associated CAA title V operating permit renewal a valid CAA title V permit to operate, with coal and ash handling, and the two application that it had submitted to the the EPA is proposing to rescind the FIP auxiliary steam boilers at NGS, and Navajo Nation Environmental Protection for NGS at 40 CFR 52.145(d) and 40 CFR established emissions limitations and Agency (Navajo Nation EPA), and 49.5513. associated continuous monitoring, requested that the EPA rescind the NGS The provisions of the 1991 FIP at 40 testing and reporting requirements for 30 FIP.22 CFR 52.145(d) applied to the fossil fuel- SO2, PM, dust, and opacity. The 2010 On December 18, 2020, the Navajo fired steam-generating units designated FIP also includes provisions related to Nation EPA notified SRP that effective as Units 1, 2, and 3, and NGS and compliance certifications, equipment 31 December 1, 2020, expiration of the title addressed emissions limitations for SO2, operations, and enforcement. V permit terminated the ability of NGS specifications for how compliance with Although the testing and monitoring to be operated.23 In that letter, the the emissions limitations would be requirements at 40 CFR 49.5513(e) Navajo Nation EPA noted that NGS had determined, requirements for generally relate to continuous emissions been operating under Permit No. NN– continuous emissions monitoring, and monitoring and periodic source testing ROP–05–06, a title V permit issued on reporting requirements.27 Because the for SO2, NOX, and PM emissions from July 7, 2008. The permit was set to the facility, one provision required SRP SO2 emissions limitations in the 1991 expire on July 7, 2013; however, FIP were achievable with the to install, maintain and operate non- because SRP submitted a timely and installation and operation of new flue regulatory ambient monitors at the Glen complete permit renewal application on gas desulfurization units, the 1991 FIP Canyon Dam for PM, nitrogen dioxide 32 March 4, 2013, NGS was able to also specified compliance dates, (NO2), SO2, and ozone. The 2010 FIP continue to operate under the existing schedules of compliance and associated did not elucidate the rationale for title V operating permit while awaiting reporting requirements.28 Finally, the ambient monitoring but generally stated action by the Navajo Nation EPA on the 1991 FIP also included various that ‘‘[t]his final action will help to 24 renewal permit application. As a provisions related to equipment advance the goals of ensuring continued complete renewal application is no operation and maintenance.29 maintenance of the national ambient air longer submitted and pending action by Under 110(l) of the CAA, the EPA quality standards and protecting 33 the Navajo Nation EPA, withdrawal of shall not approve a revision of an visibility.’’ the renewal permit application caused Because NGS has permanently ceased 25 implementation plan if the revision Permit No. NN–ROP–05–06 to expire. would interfere with any applicable operation, the air pollutants regulated Expiration of the operating permit requirements concerning attainment, under the 2010 FIP are no longer terminated the facility’s right to operate. reasonable further progress, or any other emitted from the facility, and the facility In its rescission request, SRP stated applicable requirement of the CAA. no longer operates the coal handling that since ceasing operations all Although this provision does not apply and storage equipment or the fly ash equipment permitted to operate under handling and storage equipment. the title V permit, which includes all directly to the EPA’s revision or rescission of a FIP, we have nonetheless Therefore, the provisions of the 2010 equipment subject to the NGS FIP, are FIP that regulate emissions of air non-operational and in the process of considered whether rescission of the NGS FIP would interfere with any CAA pollutants from NGS are no longer being removed. In addition, electrical necessary to satisfy any CAA and mechanical equipment had been requirements. The 1991 FIP established emissions requirements related to regional haze removed, preventing the combustion of and visibility protection. In addition, limitations for SO emitted from the fuel and equipment operation and 2 the area surrounding NGS is designated fossil fuel-fired steam-generating units eliminating sources of air pollutant attainment, unclassifiable/attainment, or at NGS, as well as associated emissions from the permitted unclassifiable for all NAAQS, therefore, compliance, monitoring, and reporting equipment. The Kayenta Mine, which the provisions of the 2010 FIP are not requirements for the flue gas supplied coal to NGS, has permanently needed to satisfy requirements desulfurization units. Because NGS has concerning attainment or reasonable 22 permanently ceased operation, these Letters dated November 30, 2020 from Joe further progress. The ambient monitors provisions are no longer necessary to Frazier, SRP, to Oliver Whaley, Navajo Nation EPA, at the Glen Canyon Dam are operated by regarding ‘‘Request to Withdraw the Pending satisfy any CAA requirements related to SRP and are not relied upon by any Renewal Application for the Navajo Generating regional haze and visibility protection. Station Title V Permit to Operate—Permit No. NN– state, local or tribal agency to satisfy the In addition, because the area ROP 05–06,’’ and dated November 30, 2020 from minimum monitoring requirements in surrounding NGS is designated Joe Frazier, SRP to John Busterud, EPA Region IX, 40 CFR part 58. Furthermore, data from regarding ‘‘Request to Rescind Navajo Generating attainment, unclassifiable/attainment, or the monitors are not reported to the Station Federal Implementation Plan at 40 CFR unclassifiable for all NAAQS, the 52.145(d) and 49.5513.’’ EPA’s Air Quality System. For these provisions of the 1991 FIP are not 23 Letter dated December 18, 2020, from Ronnie reasons, we propose to determine that Ben, Delegated Executive Director, Navajo Nation the 2010 FIP, including the provisions EPA, to Joe Frazier, Director General Engineering, 26 See, e.g., https://www.powermag.com/ SRP, Subject: ‘‘Expiration of Title V Permit to explosions-topple-smokestacks-of-iconic-navajo- Operate for Navajo Generating Station—Permit No. generating-station/, accessed on December 23, 2020. 30 40 CFR 49.5513(a) through (f). NN–ROP–05–06.’’ 27 40 CFR 52.145 (d)(1) through (5). 31 40 CFR 49.5513(g) through (i). 24 40 CFR 71.7(c)(3). 28 40 CFR 52.145(d)(6) through (8). 32 40 CFR 49.5513(e)(6). 25 Condition IX.R of Permit No. NN–ROP–05–06. 29 40 CFR 52.145(d)(9) though (13). 33 43 FR 10174, 10175 (March 5, 2010).

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requiring operation of ambient monitors C. Regulatory Flexibility Act (RFA) G. Executive Order 13045: Protection of operated at the Glen Canyon Dam, is not Children From Environmental Health needed to satisfy requirements related to I certify that this action will not have Risks and Safety Risks attainment, reasonable further progress, a significant economic impact on a visibility protection, or any other CAA substantial number of small entities The EPA interprets Executive Order requirements. under the RFA. This action will not 13045 as applying only to those The provision of the 2014 FIP at 40 impose any requirements on small regulatory actions that concern CFR 49.5513(j) were promulgated to entities. environmental health or safety risks that satisfy the BART requirements of the the EPA has reason to believe may CAA and the Regional Haze Rule and D. Unfunded Mandates Reform Act disproportionately affect children, per established emissions limitations for (UMRA) the definition of ‘‘covered regulatory action’’ in section 2–202 of the NOX from NGS and associated This action does not contain any requirements, including implementation Executive Order. This action is not unfunded mandate as described in subject to Executive Order 13045 schedules, reporting, monitoring, UMRA, 2 U.S.C. 1531–1538, and does compliance determinations, because it does not concern an not significantly or uniquely affect small environmental health risk or safety risk. recordkeeping, equipment operations, governments. The action imposes no and enforcement.34 Because NGS has enforceable duty on any state, local or H. Executive Order 13211: Actions That permanently ceased operation, the tribal governments or the private sector. Significantly Affect Energy Supply, emissions of NOX regulated under the Distribution, or Use 2014 FIP have also permanently ceased. E. Executive Order 13132: Federalism Therefore, the provisions of the 2014 This action is not subject to Executive FIP, which were intended to satisfy This action does not have federalism Order 13211, because it is not a CAA requirements for visibility implications. It will not have substantial significant regulatory action under protection, are no longer necessary. In direct effects on the states, on the Executive Order 12866. addition, the area surrounding NGS is relationship between the national I. National Technology Transfer and designated attainment, unclassifiable/ government and the states, or on the Advancement Act (NTTAA) attainment, or unclassifiable for all distribution of power and NAAQS. Therefore, we propose to find responsibilities among the various This rulemaking does not involve that the provisions of the 2014 FIP are levels of government. technical standards. not needed to satisfy requirements concerning attainment or reasonable F. Executive Order 13175: Coordination J. Executive Order 12898: Federal further progress or any other applicable With Indian Tribal Governments Actions To Address Environmental CAA requirements. Justice in Minority Populations and This action does not have tribal Low-Income Populations III. Solicitation of Comments implications, as specified in Executive The EPA believes that this action is As described above, the EPA is Order 13175. The Navajo Generating not subject to Executive Order 12898 (59 proposing the rescind the NGS FIP from Station is located on the reservation FR 7629, February 16, 1994) because it 40 CFR 52.145(d) and 40 CFR 49.5513. lands of the Navajo Nation, and the EPA does not establish an environmental The EPA solicits comments on this recognizes there is significant health or safety standard. The facility proposed FIP rescission and will accept community and tribal interest in this has already permanently ceased comments until April 15, 2021. facility. The facility has already permanently ceased operations and this operations and this action simply IV. Statutory and Executive Order action simply proposes to rescind proposes to rescind previously Reviews previously promulgated requirements promulgated requirements applicable to Additional information about these applicable to this shuttered facility. In this shuttered facility. Therefore, the statutes and Executive Orders can be addition, the Navajo Nation EPA has EPA considers this proposed action to found at http://www.epa.gov/laws- already determined that NGS no longer rescind the NGS FIP to have no impacts regulations/laws-and-executive-orders. has the right to operate. This proposed to human health and the environment, and to have no potential A. Executive Order 12866: Regulatory action to rescind the NGS FIP will not have substantial direct effects on any disproportionately high and adverse Planning and Review and Executive effects on minority, low-income, or Indian tribes, on the relationship Order 13563: Improving Regulation and indigenous populations. Regulatory Review between the federal government and Indian tribes, or on the distribution of List of Subjects This action is not a significant power and responsibilities between the regulatory action and was therefore not 40 CFR Part 49 federal government and Indian tribes. submitted to the Office of Management Thus, Executive Order 13175 does not and Budget for review. This proposed Administrative practice and apply to this action. However, on rule applies to only one facility and is procedure, Air pollution control, January 7, 2021, we invited the Navajo therefore not a rulemaking of general Environmental protection, Incorporation applicability. Nation to consult on this proposed by reference, Indians, Intergovernmental action.35 The Navajo Nation did not relations, Reporting and recordkeeping B. Paperwork Reduction Act (PRA) request consultation on this proposed requirements. This action does not impose an FIP rescission. 40 CFR Part 52 information collection burden under the PRA because this action does not 35 Letter dated January 7, 2021 from Elizabeth J. Air pollution control, Environmental contain any information collection Adams, EPA Region IX, to Jonathan Nez, President protection, Incorporation by reference, of the Navajo Nation, Re: Invitation to Consult on activities. a Request from the Salt River Project to Rescind the Intergovernmental relations, Particulate Federal Implementation Plan for the Navajo matter, Reporting and recordkeeping 34 40 CFR 49.5513(j)(1) through (11). Generating Station. requirements, Visibility.

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Dated: February 22, 2021. [email protected]. Follow the online sulfur dioxide. Each federally-approved Deborah Jordan, instructions for submitting comments. SIP protects air quality primarily by Acting Regional Administrator, Region IX. Once submitted, comments cannot be addressing air pollution at its point of For the reasons stated in the edited or removed from Regulations.gov. origin through air pollution regulations preamble, the Environmental Protection The EPA may publish any comment and control strategies. The EPA Agency proposes to amend chapter I, received to its public docket. Do not approved SIP regulations and control strategies are federally enforceable. title 40, of the Code of Federal submit electronically any information An Economic Incentive Program (EIP) Regulations as follows: you consider to be Confidential Business Information (CBI) or other is a program that uses market-based PART 49—INDIAN COUNTRY: AIR information whose disclosure is strategies to reduce emissions of air 1 QUALITY PLANNING AND restricted by statute. Multimedia pollutants. The Texas Diesel Emissions MANAGEMENT submissions (audio, video, etc.) must be Reduction Incentive Program (DERIP) accompanied by a written comment. for On-Road and Non-Road Vehicles is ■ 1. The authority citation for part 49 The written comment is considered the part of the Texas Emissions Reduction continues to read as follows: official comment and should include Program (TERP) that was established by the Texas Legislature in 2001 and Authority: 42 U.S.C. 7401, et seq. discussion of all points you wish to make. The EPA will generally not approved in the Texas SIP as an Subpart L—Implementation plans for consider comments or comment economic incentive program (70 FR tribes—Region IX contents located outside of the primary 48647, August 19, 2005). DERIP submission (i.e. on the web, cloud, or provides grants to eligible individuals, § 49.5513 [Removed and Reserved] other file sharing system). For businesses, or local governments to ■ 2. Remove and reserve § 49.5513. additional submission methods, please reduce emissions from diesel-powered contact Carl Young, 214–665–6645, vehicles and equipment in areas PART 52—APPROVAL AND [email protected]. For the full EPA designated as nonattainment for a PROMULGATION OF public comment policy, information NAAQS or other counties identified by 2 IMPLEMENTATION PLANS about CBI or multimedia submissions, the Texas Legislature. In 2019 the Texas Legislature revised ■ and general guidance on making 3. The authority citation for part 52 the eligibility requirements for DERIP. continues to read as follows: effective comments, please visit https:// www.epa.gov/dockets/commenting-epa- As a result, the Texas Commission on Authority: 42 U.S.C. 7401, et seq. dockets. Environmental Quality (TCEQ) revised the DERIP regulations found in Title 30, Subpart D—Arizona Docket: The index to the docket for this action is available electronically at Chapter 114 (Control of Air Pollution § 52.145 [Amended] www.regulations.gov. While all from Motor Vehicles) of the Texas Administrative Code (30 TAC 114). The ■ documents in the docket are listed in 4. Amend § 52.145 by removing and revisions were adopted on June 10, 2020 reserving paragraph (d). the index, some information may not be publicly available due to docket file size and submitted to the EPA as a SIP [FR Doc. 2021–04352 Filed 3–15–21; 8:45 am] restrictions or content (e.g., CBI). revision on August 13, 2020. BILLING CODE 6560–50–P Specifically, the TCEQ revisions: (1) FOR FURTHER INFORMATION CONTACT: Carl Changed the minimum required usage Young, EPA Region 6 Office, for grant-funded vehicles and ENVIRONMENTAL PROTECTION Infrastructure and Ozone Section, 214– equipment in the eligible area from 75% AGENCY 665–6645, [email protected]. Out of to 55% (30 TAC 114.622), and (2) an abundance of caution for members of removed Victoria County from the list of 40 CFR Part 52 the public and our staff, the EPA Region counties eligible for DERIP grants (30 6 office will be closed to the public to [EPA–R06–OAR–2020–0713; FRL–10020– TAC 114.629). A copy of the SIP 73–Region 6] reduce the risk of transmitting COVID– revision submitted to EPA is available 19. We encourage the public to submit in the electronic docket for this action. Air Plan Approval; Texas; Revisions to comments via https:// the Texas Diesel Emissions Reduction www.regulations.gov, as there will be a II. The EPA’s Evaluation Incentive Program delay in processing mail and no courier We approved DERIP regulations into or hand deliveries will be accepted. the Texas SIP in 2005 (70 FR 48647, AGENCY: Environmental Protection Please call or email the contact listed August 19, 2005). More recently, we Agency (EPA). above if you need alternative access to approved updates to DERIP regulations ACTION: Proposed rule. material indexed but not provided in in 2018 (83 FR 50018, October 4, 2018). the docket. This SIP revision further updates DERIP SUMMARY: Pursuant to the Federal Clean SUPPLEMENTARY INFORMATION: regulations. The effect of this update is Air Act (CAA or the Act), the Throughout this document wherever to: (1) Allow more diesel vehicles and Environmental Protection Agency (EPA) ‘‘we,’’ ‘‘us,’’ or ‘‘our’’ is used, we mean equipment in nonattainment areas or is proposing to approve a revision to the the EPA. Texas State Implementation Plan (SIP) 1 For more information on EIPs see ‘‘Improving that pertains to the Texas Diesel I. Background Air Quality with Economic Incentive Programs’’, Emissions Reduction Incentive Program, Section 110 of the CAA requires states EPA–452/R–01–001, January 2001, available at submitted on August 13, 2020. https://www.epa.gov/sites/production/files/2015- to develop and submit to the EPA a SIP 07/documents/eipfin.pdf. DATES: Written comments must be to ensure that state air quality meets 2 For more information on TERP and DERIP received on or before April 15, 2021. National Ambient Air Quality Standards please see ‘‘Texas Emissions Reduction Plan ADDRESSES: Submit your comments, (NAAQS). These ambient standards Biennial Report (2019–2020), Report to the 87th Texas Legislature, December 2020, SFR–079/20’’. identified by Docket No. EPA–R06– currently address six criteria pollutants: The document is available at: https:// OAR–2020–0713, at https:// Carbon monoxide, nitrogen dioxide, www.tceq.texas.gov/assets/public/comm_exec/ www.regulations.gov or via email to ozone, lead, particulate matter, and pubs/sfr/079-20.pdf.

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affected counties to be eligible for grant NAAQS. Not providing grants to reduce meeting Federal requirements and does funding (30 TAC 114.622) and (2) emissions from diesel equipment will not impose additional requirements exclude Victoria County from eligibility not cause emissions to increase in beyond those imposed by state law. For for DERIP grants (30 TAC 114.629). Victoria county. Instead emissions in that reason, this action: Section 110(l) of the CAA requires the county will not be impacted by this • Is not a ‘‘significant regulatory that EPA shall not approve a SIP SIP revision. Therefore, approval of the action’’ subject to review by the Office revision if the revision would interfere revision to 30 TAC 114.629 will not of Management and Budget under with any applicable requirement contribute to nonattainment or interfere Executive Orders 12866 (58 FR 51735, concerning attainment and reasonable with maintenance in Victoria County. October 4, 1993) and 13563 (76 FR 3821, further progress (as defined in Section As more diesel equipment become January 21, 2011); 171 of the CAA) or any other applicable eligible, the concentration of the DERIP • Does not impose an information requirements of the CAA. DERIP is a program in nonattainment areas will collection burden under the provisions voluntary incentive program for likely result in additional emission of the Paperwork Reduction Act (44 reducing emissions and is not a reductions. As additional grants are U.S.C. 3501 et seq.); requirement of the Act. The inclusion of issued to reduce emissions from diesel • Is certified as not having a DERIP in the SIP, therefore, is equipment, the air quality will benefit, significant economic impact on a discretionary and as such, revisions can which will assist in maintenance and substantial number of small entities be made as long as they do not attainment of the NAAQS. Therefore, under the Regulatory Flexibility Act (5 contribute to nonattainment or interfere the proposed approval of the SIP U.S.C. 601 et seq.); with maintenance. Reductions from the revision is consistent with the CAA • TERP program were part of the emission section 110(1). Also, because the Does not contain any unfunded reductions in SIP revisions relied upon program is discretionary, it will not mandate or significantly or uniquely to provide for attainment of (1) the 1997 interfere with any applicable affect small governments, as described ozone standard in the Dallas-Fort Worth requirement for attainment and in the Unfunded Mandates Reform Act area (70 FR 15592, March 28, 2005) and of 1995 (Pub. L. 104–4); reasonable further progress, or any other • (2) the 1-hour ozone standard in the applicable requirement of the CAA. Does not have federalism Houston-Galveston-Brazoria area (71 FR Because the revised program will implications as specified in Executive 52670, September 6, 2006). The continue to achieve additional Order 13132 (64 FR 43255, August 10, reductions relied upon in these plans reductions not relied upon by any plan 1999); • have long been achieved through grants for attainment or maintenance, the Is not an economically significant and rebates that have already been revisions will not contribute to regulatory action based on health or issued and none of the subsequent nonattainment or interfere with safety risks subject to Executive Order ozone attainment plans submitted by maintenance. 13045 (62 FR 19885, April 23, 1997); the State have relied upon reductions • Is not a significant regulatory action from the TERP or DERIP programs. III. Proposed Action subject to Executive Order 13211 (66 FR However, the State could use DERIP as We are proposing to approve the 28355, May 22, 2001); a tool in future SIP revisions to obtain revisions to 30 TAC 114.622 and • Is not subject to requirements of needed emission reductions. 114.629 adopted on June 10, 2020 and section 12(d) of the National As noted above, revisions to 30 TAC submitted on August 13, 2020. Technology Transfer and Advancement 114.622 changed the amount of time IV. Incorporation by Reference Act of 1995 (15 U.S.C. 272 note) because equipment needs to operate in the application of those requirements would affected counties. This change will In this action, we are proposing to be inconsistent with the CAA; and provide for an increase in the pool of include in a final rule regulatory text • Does not provide EPA with the vehicles and equipment eligible for this that includes incorporation by discretionary authority to address, as program and potentially generate more reference. In accordance with the appropriate, disproportionate human emission reductions through future state requirements of 1 CFR 51.5, we are health or environmental effects, using grants. Some of these reductions, proposing to incorporate by reference practicable and legally permissible however, will likely be outside of revisions to the Texas regulations as methods, under Executive Order 12898 designated nonattainment areas. As described in the Proposed Action (59 FR 7629, February 16, 1994). Texas is not relying on emission section above. We have made, and will In addition, the SIP is not approved reductions from future DERIP grants, it continue to make, these documents to apply on any Indian reservation land is not necessary for the reductions to generally available electronically or in any other area where EPA or an occur exactly in an affected through www.regulations.gov (please Indian tribe has demonstrated that a nonattainment area. contact the person identified in the FOR tribe has jurisdiction. In those areas of As stated previously, DERIP and FURTHER INFORMATION CONTACT section of Indian country, the proposed rule does TERP are not mandated by the Clean Air this preamble for more information). Act. The implementation of these not have tribal implications and will not programs is discretionary. The Texas V. Statutory and Executive Order impose substantial direct costs on tribal legislature originally adopted the Reviews governments or preempt tribal law as programs to apply in nonattainment Under the CAA, the Administrator is specified by Executive Order 13175 (65 areas and other affected areas deemed required to approve a SIP submission FR 67249, November 9, 2000). near-nonattainment areas. None of the that complies with the provisions of the List of Subjects in 40 CFR Part 52 reductions that will be achieved by Act and applicable Federal regulations. these programs going forward are being 42 U.S.C. 7410(k); 40 CFR 52.02(a). Environmental protection, Air relied upon in any plan for any affected Thus, in reviewing SIP submissions, the pollution control, Incorporation by area in Texas. The Texas legislature EPA’s role is to approve state choices, reference, Nitrogen dioxide, Ozone, decided that it no longer should provided that they meet the criteria of Particulate matter, Reporting and implement the program in Victoria the CAA. Accordingly, this action recordkeeping requirements. County which is meeting all current merely proposes to approve state law as Authority: 42 U.S.C. 7401 et seq.

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Dated: March 10, 2021. associated with these final rules; and (decaBDE) (CASRN 1163–19–5); phenol, David Gray, whether to consider additional or isopropylated phosphate (3:1) (PIP (3:1)) Acting Regional Administrator, Region 6. alternative measures or approaches. In (CASRN 68937–41–7); [FR Doc. 2021–05329 Filed 3–15–21; 8:45 am] particular, EPA is seeking comment on pentachlorothiophenol (PCTP) (CASRN BILLING CODE 6560–50–P specifics of recently raised issues 133–49–3); and hexachlorobutadiene regarding the compliance date for the (HCBD) (CASRN 87–68–3). The action prohibition on the processing and may also be of interest to persons who ENVIRONMENTAL PROTECTION distribution of PIP (3:1) for use in currently or may manufacture AGENCY articles, and PIP (3:1)-containing (including import), process, distribute, articles. use, and/or dispose of products and 40 CFR Part 751 DATES: Comments must be received on articles containing these PBT chemicals. [EPA–HQ–OPPT–2021–0202; FRL–10021– or before May 17, 2021. Non-governmental organizations in the environmental and public health 08] ADDRESSES: Submit your comments, sectors, state and local government identified by docket identification (ID) Regulation of Persistent, agencies, and members of the public number EPA–HQ–OPPT–2021–0202, Bioaccumulative, and Toxic Chemicals may also be interested in this action. through the Federal eRulemaking Portal Under TSCA Section 6(h); Request for Since other entities may also be at http://www.regulations.gov. Follow Comments interested, EPA has not attempted to the online instructions for submitting describe all the specific entities that AGENCY: Environmental Protection comments. Do not submit electronically may be affected by this action. Agency (EPA). any information you consider to be ACTION: Proposed rule. Confidential Business Information (CBI) B. What is EPA’s authority for taking or other information whose disclosure is this action? SUMMARY: In accordance with the restricted by statute. To make special January 21, 2021, Executive Order arrangements for hand delivery or EPA issued the final rules under entitled ‘‘Protecting Public Health and delivery of boxed information, please TSCA section 6(h), 15 U.S.C. 2601 et the Environment and Restoring Science follow the instructions at http:// seq., for five persistent, to Tackle the Climate Crisis’’ and other www.epa.gov/dockets/contacts.html. bioaccumulative, and toxic (PBT) Biden-Harris Administration Executive Please note that due to the public chemical substances that met the orders and other direction, the health emergency the EPA Docket statutory criteria. More specifically, Environmental Protection Agency (EPA) Center (EPA/DC) and Reading Room under TSCA section 6(h), EPA must take is requesting additional public were closed to public visitors on March expedited action on those chemical comments on five final rules recently 31, 2020. Our EPA/DC staff will substances identified in the 2014 issued under the Toxic Substances continue to provide customer service Update to the TSCA Work Plan for Control Act (TSCA). On January 6, 2021, via email, phone, and webform. For Chemical Assessments (Ref. 1) that, EPA issued final rules to address its further information on EPA/DC services, among other factors, EPA has a obligations under TSCA for five docket contact information and the reasonable basis to conclude are toxic persistent, bioaccumulative, and toxic current status of the EPA/DC and and that with respect to persistence and (PBT) chemicals that EPA determined Reading Room, please visit https:// bioaccumulation score high for one and met the criteria for expedited action www.epa.gov/dockets. either high or moderate for the other, under TSCA. These chemicals are 2,4,6- FOR FURTHER INFORMATION CONTACT: pursuant to the TSCA Work Plan tris(tert-butyl)phenol (2,4,6-TTBP) For technical information contact: Chemicals: Methods Document (Ref. 2). (CASRN 732–26–3); decabromodiphenyl Cindy Wheeler, Existing Chemicals Risk The chemical substances that meet these ether (decaBDE) (CASRN 1163–19–5); Management Division (Mail Code criteria are 2,4,6-TTBP, decaBDE, PIP phenol, isopropylated phosphate (3:1) 7404T), Office of Pollution Prevention (3:1), PCTP, and HCBD. Under TSCA, if (PIP (3:1)) (CASRN 68937–41–7); and Toxics, Environmental Protection EPA determines that exposure is likely pentachlorothiophenol (PCTP) (CASRN Agency, 1200 Pennsylvania Ave. NW, to a chemical meeting these criteria, 133–49–3); and hexachlorobutadiene Washington, DC 20460–0001; telephone EPA must issue a rule that addresses the (HCBD) (CASRN 87–68–3). PBT number: (202) 566–0484; email address: risks of injury to health or the chemicals are of particular concern in [email protected]. environment that the Administrator the Agency’s efforts to protect human For general information contact: The determines are presented and reduces health and the environment because TSCA-Hotline, ABVI-Goodwill, 422 exposure to the chemical to the extent they are toxic and remain in the South Clinton Ave., Rochester, NY practicable. Based on the ‘‘Exposure and environment for long periods of time 14620; telephone number: (202) 554– Use Assessment of Five Persistent, and can build up or accumulate in the 1404; email address: TSCA-Hotline@ Bioaccumulative and Toxic Chemicals body. As a first step in its efforts to epa.gov. Assessment’’ (Ref. 3), EPA determined immediately review these rules to that exposure was likely to all five of the determine whether they are consistent SUPPLEMENTARY INFORMATION: PBT chemicals. On January 6, 2021, with the Administration policy to limit I. General Information EPA issued a final rule for each of the exposure to dangerous chemicals (and five chemicals under TSCA section 6(h), to determine whether and how these A. Does this apply to me? meeting the Agency’s obligation to rules should be revised), EPA invites This document is directed to the promulgate the rules within 18 months public comment on the final rules, public in general and may be of interest of issuance of the proposed rules (Refs. including whether there are further to persons who currently or may 4–8). With the obligation to promulgate exposure reductions that could be manufacture (including import), these rules, the Agency also has the achieved, including exposure process, distribute, use, and/or dispose authority to amend them if reductions for potentially exposed or of the five PBT chemicals: 2,4,6-tris(tert- circumstances change, including in susceptible subpopulations and the butyl)phenol (2,4,6-TTBP) (CASRN 732– relation to the receipt of new environment; implementation issues 26–3); decabromodiphenyl ether information.

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C. What action is EPA taking? details on the requirements adopted and invertebrates, fish, and terrestrial EPA is inviting public comment on the rationale for those requirements. invertebrates. Data indicate the potential for developmental, neurological, and the provisions of the final rules. The A. 2,4,6-tris(tert-butyl)phenol (2,4,6- immunological effects, general Agency is broadly re-examining TSCA TTBP); Regulation of Persistent, developmental toxicity, liver effects, section 6(h) requirements and other Bioaccumulative, and Toxic Chemicals and carcinogenicity. The final rule for provisions of amended TSCA, including Under TSCA Section 6(h) (RIN 2070– decaBDE (Ref. 5) prohibits the determining how the new Executive AK59) orders and other direction provided by manufacture (including import) and Uses of 2,4,6-TTBP may be grouped processing of decaBDE, and products the Biden-Harris Administration (Refs. into four general categories: (1) 9–13) will be addressed, as well as new and articles containing decaBDE, as of Domestic manufacture and use as an March 8, 2021. Distribution in information received from stakeholders. intermediate/reactant in processing at As part of this process, EPA will review commerce of products and articles to chemical facilities; (2) use in which decaBDE has been added is and consider revising the final PBT formulations and mixtures for fuel rules with an eye towards reducing prohibited as of January 6, 2022. treatment in refineries and fuel Different compliance dates or exposure to the extent practicable, facilities; (3) use in formulations environmental justice, scientific exclusions include: intended for the maintenance or repair • Manufacture, processing, and integrity, and EPA’s mission of of motor vehicles and machinery at distribution in commerce for use in protecting human health and the small commercial operations and for curtains in the hospitality industry after environment, taking into consideration retail sale, and (4) use in formulations July 6, 2022; information received while the rules and mixtures for liquid lubricant and • Processing and distribution in were under development as well as any grease additives/antioxidants additives. commerce for use in wire and cable new information submitted since the 2,4,6-TTBP is toxic to aquatic plants, insulation in nuclear power generation rules were finalized and information aquatic invertebrates, and fish. facilities after January 6, 2023; received in response to this document. Surveyed animal data indicate the • Manufacture, processing, and EPA is also aware of and plans to potential for liver and developmental distribution in commerce for use in consider revisions in response to effects. The final rule for 2,4,6-TTBP parts for new aerospace vehicles after implementation issues that have been (Ref. 4) prohibits the distribution in January 8, 2024; raised by a range of stakeholders. In commerce of 2,4,6-TTBP and products • Manufacture, processing, and particular, EPA is seeking comment on containing 2,4,6-TTBP at concentrations distribution in commerce for use in newly-raised issues associated with the above 0.3% by weight in any container replacement parts for aerospace vehicles March 8, 2021, compliance date in the with a volume of less than 35 gallons in until the end of the vehicles’ service PIP (3:1) rule for certain regulated order to minimize the use of 2,4,6-TTBP lives; articles. as a fuel additive or fuel injector cleaner • Manufacture, processing, and D. What should I consider as I prepare by consumers and small commercial distribution in commerce for use in my comments for EPA? operations (e.g., automotive repair replacement parts for motor vehicles shops, marinas). The final rule also until the end of the vehicles’ service 1. Submitting CBI. Do not submit this prohibits the processing and lives or 2036, whichever is earlier; information to EPA through distribution in commerce of 2,4,6-TTBP, • Distribution in commerce of plastic regulations.gov or email. Clearly mark and products containing 2,4,6-TTBP, for shipping pallets manufactured prior to the part or all of the information that use as an oil or lubricant additive in the publication of the final rule that you claim to be CBI. For CBI concentrations above 0.3% by weight contain decaBDE until the end of the information in a disk or CD–ROM that regardless of container size. The final pallets service lives; and you mail to EPA, mark the outside of the rule includes a number of broad • Processing and distribution in disk or CD–ROM as CBI and then exclusions or definitions intended to commerce for recycling of plastic that identify electronically within the disk or apply to each of the five PBT rules, contained decaBDE before the plastic CD–ROM the specific information that including definitions of article and was recycled, and the articles and is claimed CBI. In addition to one product and exclusions for research and products made from such recycled complete version of the comment that development, disposal, and the resale of plastic so long as no new decaBDE is includes information claimed as CBI, a products and articles previously sold to added during the recycling or copy of the comment that does not an end user. production process. contain the information claimed as CBI must be submitted for inclusion in the B. Decabromodiphenyl Ether C. Phenol, Isopropylated Phosphate public docket. Information so marked (DecaBDE); Regulation of Persistent, (3:1) (PIP 3:1); Regulation of Persistent, will not be disclosed except in Bioaccumulative, and Toxic Chemicals Bioaccumulative, and Toxic Chemicals accordance with procedures set forth in Under TSCA Section 6(h) (RIN 2070– Under TSCA Section 6(h) (RIN 2070– 40 CFR part 2. AK34) AK58) 2. Tips for preparing your comments. DecaBDE (Ref. 5) is used as an PIP (3:1) (Ref. 6) is used as a When preparing and submitting your additive flame retardant in plastic plasticizer, a flame retardant, an anti- comments, see the commenting tips at enclosures for televisions, computers, wear additive, or an anti-compressibility http://www.epa.gov/dockets/ audio and video equipment, textiles and additive in hydraulic fluid, lubricating comments.html. upholstered articles, wire and cables for oils, lubricants and greases, various communication and electronic industrial coatings, adhesives, sealants, II. Summary of the Final PBT Rules equipment, and other applications. and plastic articles. PIP (3:1) is toxic to This unit provides a summary of the DecaBDE is also used as a flame aquatic plants, aquatic invertebrates, five TSCA section 6(h) final rules that retardant for multiple applications for sediment invertebrates and fish. Data published in the Federal Register of aerospace and automotive vehicles, indicate the potential for reproductive January 6, 2021. However, each rule including replacement parts for aircraft and developmental effects, neurological should be consulted for additional and cars. DecaBDE is toxic to aquatic effects and effects on systemic organs,

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specifically adrenals, liver, ovary, heart, concentrations are at or below 1% by and distribution of PIP (3:1) could and lungs. The PIP (3:1) final rule (Ref. weight. A prohibition on the impact articles used in a wide variety of 6) prohibits processing and distribution distribution in commerce of PCTP or electronics, from cell phones, to robotics in commerce of PIP (3:1), and products PCTP-containing products or articles, used to manufacture semiconductors, to or articles containing the chemical unless PCTP concentrations are at or equipment used to move COVID–19 substance, for all uses, except for the below 1% by weight, will take effect on vaccines and keep them at the following different compliance dates or January 6, 2022. appropriate temperature. Stakeholders exclusions: E. Hexachlorobutadiene (HCBD); note that the complexity of international • Use in photographic printing Regulation of Persistent, supply chains makes locating the articles after January 1, 2022; Bioaccumulative, and Toxic Chemicals presence of, and finding alternatives to, • Use in aviation hydraulic fluid in Under TSCA Section 6(h) (RIN 2070– PIP (3:1) in components challenging. hydraulic systems and use in specialty AK61) They assert that an extension to the hydraulic fluids for military compliance deadline is necessary to applications; HCBD is a halogenated aliphatic avoid significant disruption to the • Use in lubricants and greases; hydrocarbon that is produced as an supply chain for a wide variety of • Use in new and replacement parts unintentional byproduct during the articles. It was clearly not EPA’s intent for the aerospace and automotive manufacture of chlorinated during the development of the rule to industries; hydrocarbons, particularly • have such a broad disruptive impact. Use as an intermediate in the perchloroethylene, trichloroethylene, Nonetheless, compliance deadlines for manufacture of cyanoacrylate glue; and carbon tetrachloride, and is • the PBT rules must be in place ‘‘as soon Use in specialized engine air filters subsequently burned as a waste fuel. as practicable’’ and provide reasonable for locomotive and marine applications; HCBD is toxic to aquatic invertebrates, transition periods, pursuant to the • Use in sealants and adhesives after fish, and birds, and has been identified requirements of TSCA section 6(d)(1). January 6, 2025; and as a possible human carcinogen. Data Thus, for EPA to amend the existing • Recycling of plastic that contained indicate the potential for renal, deadline, the Agency needs additional PIP (3:1) before the plastic was recycled, reproductive, and developmental information regarding the impact of the and the articles and products made from effects. The final rule for HCBD (Ref. 8) deadline. EPA specifically asks such recycled plastic, so long as no new prohibits the manufacture (including commenters to specify the articles that PIP (3:1) is added during the recycling import), processing, and distribution in need the alternative deadline; the basis or production process. commerce of HCBD and HCBD- for the alternative deadline, taking into In addition, the final rule requires containing products or articles, except consideration the reasons supporting manufacturers, processors, and for the unintentional production of alternative deadlines in the final rule distributors of PIP (3:1) and products HCBD as a byproduct during the already issued, such as the January 1, containing PIP (3:1) to notify their production of chlorinated solvents, and 2022, date for photographic printing customers of these restrictions. Finally, the processing and distribution in articles and the January 6, 2025, date for the rule prohibits releases to water from commerce of HCBD for burning as a adhesives and sealants, with supporting the remaining manufacturing, waste fuel. processing, and distribution in documentation; and the additional time commerce activities, and requires III. Request for Comment needed for specific articles to clear commercial users of PIP (3:1) and PIP During the comment period, the channels of trade. EPA plans to address (3:1)-containing products to follow public may submit comments and the compliance deadline in the PIP (3:1) existing regulations and best practices to information relevant to any aspect of the rule as part of the broader re- prevent releases to water during use. final PBT rules. The public is examination of these rules and will take encouraged to provide comments and into account comments received during D. Pentachlorothiophenol (PCTP); information relating to EPA’s statutory this comment period when deciding Regulation of Persistent, obligations under TSCA section 6(h) upon future action involving this Bioaccumulative, and Toxic Chemicals and the extent to which there are further matter. In the meantime, the Agency Under TSCA Section 6(h) (RIN 2070– exposure reductions that could be will exercise its enforcement discretion AK60) achieved, including exposure to not pursue enforcement actions for PCTP was used in rubber reductions for potentially exposed or violations of the prohibitions on the manufacturing as a peptizer, or a susceptible subpopulations and the processing and distribution of PIP (3:1) chemical that makes rubber more environment. EPA is particularly for use in articles, or articles containing amenable to processing. Although it is interested in information relating to the PIP (3:1) for up to 180 days, while this likely that PCTP is no longer used as a impacts of the final rules on human review and agency action to address this peptizer, it can be found as an impurity health, including potentially exposed or matter are pending. in the zinc salt of PCTP (zinc PCTP) susceptible subpopulations, and the III. References (CASRN 117–97–5) after zinc PCTP environment. EPA is also requesting manufacturing. PCTP is toxic to comment on implementation issues 1. EPA. TSCA Work Plan for Chemical protozoa, fish, terrestrial plants, and associated with these final rules. EPA Assessments: 2014 Update. October birds. Data for analogous chemicals specifically invites public comment on 2014. https://www.epa.gov/ (pentachloronitrobenzene and additional measures or approaches that assessingandmanaging-chemicals-under- hexachlorobenzene) indicate the tsca/tscawork-plan-chemical- EPA could take in addition to the assessments-2014-update. Accessed potential for liver and reproductive provisions in the final rules. March 1, 2019. effects. However, no animal or human In particular, EPA is seeking comment 2. EPA. TSCA Work Plan Chemicals: hazard data has been identified. The on newly-raised issues associated with Methods Document. February 2012. final rule for PCTP (Ref. 7) prohibits all the March 8, 2021 compliance date in https://www.epa.gov/sites/production/ manufacturing (including import) and the PIP (3:1) rule for certain regulated files/2014-03/documents/work_plan_ processing of PCTP, and products or articles. Stakeholders recently informed methods_document_web_final.pdf. articles containing PCTP, unless PCTP EPA that the prohibition on processing Accessed March 1, 2019.

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3. EPA. Exposure and Use Assessment of FEDERAL COMMUNICATIONS SUMMARY: NMFS announces that the Five Persistent, Bioaccumulative, and COMMISSION Pacific Fishery Management Council Toxic Chemicals. December 2020. has submitted Amendment 18 to the 4. EPA. 2,4,6-Tris(tert-butyl)phenol (2,4,6- 47 CFR Part 73 Coastal Pelagic Species Fishery TTBP); Regulation of Persistent, [MB Docket No. 21–49; RM–11874; DA 21– Management Plan for review by the Bioaccumulative, and Toxic Chemicals 158; FR ID 17557] Secretary of Commerce. Amendment 18 Under TSCA Section 6(h); Final Rule. would implement a rebuilding plan for Federal Register (86 FR 866, January 6, Television Broadcasting Services; the northern subpopulation of Pacific 2021) (FRL–10018–90). Augusta, Georgia sardine, which NMFS declared 5. EPA. Decabromodiphenyl Ether overfished in June 2019. NMFS will AGENCY: Federal Communications (DecaBDE); Regulation of Persistent, consider public comments in deciding Commission. Bioaccumulative, and Toxic Chemicals whether to approve, disapprove, or Under TSCA Section 6(h); Final Rule. ACTION: Proposed rule; correction. partially approve Amendment 18. Federal Register (86 FR 880, January 6, DATES: Comments on Amendment 18 2021) (FRL–10018–87). SUMMARY: The Federal Communications must be received by May 17, 2021. 6. EPA. Phenol, Isopropylated Phosphate Commission published a document in (3:1) (PIP 3:1)); Regulation of Persistent, the Federal Register of March 8, 2021, Comments on the associated Bioaccumulative, and Toxic Chemicals concerning a petition for rulemaking Environmental Assessment must be Under TSCA Section 6(h); Final Rule. filed by Gray Television Licensee, LLC received by April 15, 2021. Federal Register (86 FR 894, January 6, (Gray) requesting the substitution of ADDRESSES: You may submit comments 2021) (FRL–10018–88). channel 27 for channel 12 at Augusta, on this document, identified by NOAA– 7. EPA. Pentachlorothiophenol (PCTP); Georgia in the DTV Table of Allotments. NMFS–0008–2021, by the following Regulation of Persistent, The document contained the incorrect electronic methods: Bioaccumulative, and Toxic Chemicals address for counsel of petitioner. • The Pacific Fishery Management Under TSCA Section 6(h); Final Rule. FOR FURTHER INFORMATION CONTACT: Council and NMFS prepared a draft Federal Register (86 FR 911, January 6, Andrew Manley, Andrew.Manley@ excerpt of the Coastal Pelagic Species 2021) (FRL–10018–89). fcc.gov, Media Bureau, (202) 418–0596. Fishery Management Plan as amended 8. EPA. Hexachlorobutadiene (HCBD); through Amendment 18, with notations Correction Regulation of Persistent, showing how Amendment 18 would Bioaccumulative, and Toxic Chemicals In the Federal Register of March 8, change the Fishery Management Plan, if Under TSCA Section 6(h); Final Rule. 2021, in FR Vol. 86, No. 43, on page approved. This draft can be viewed via Federal Register (86 FR 922, January 6, 13278, in the second column, correct the Federal eRulemaking Portal: http:// 2021) (FRL–10018–91). the ADDRESSES caption to read: www.regulations.gov, docket NOAA– 9. Executive Order 13985. Advancing Racial ADDRESSES: Federal Communications NMFS–0008–2021 or by contacting the Equity and Support for Underserved Commission, Office of the Secretary, 45 Pacific Fisheries Management Council, Communities Through the Federal L Street NE, Washington, DC 20554. In 7700 NE Ambassador Place, Suite 101, Government. Federal Register (86 FR addition to filing comments with the Portland, OR 97220–1384. In order to 7009, January 25, 2021). FCC, interested parties should serve comment on this document and the 10. Executive Order 13990. Protecting Public counsel for petitioner as follows: Joan draft Amendment 18 language, submit Health and the Environment and Stewart, Esq., Wiley Rein LLP, 1776 K all electronic public comments via the Restoring Science to Tackle the Climate Street NW, Washington, DC 20006. Federal e-Rulemaking Portal. Go to Crisis. Federal Register (86 FR 7037, of Dated: March 9, 2021. www.regulations.gov and enter NOAA– January 25, 2021). Thomas Horan, NMFS–0008–2021 in the Search box. 11. Executive Order 14008. Tackling the Click the ‘‘Comment’’ icon and Chief of Staff, Media Bureau. Climate Crisis at Home and Abroad. complete the required fields, and enter Federal Register (86 FR 7619, February [FR Doc. 2021–05394 Filed 3–15–21; 8:45 am] or attach your comments. 1, 2021). BILLING CODE 6712–01–P • The Pacific Fishery Management 12. Presidential Memorandum. Memorandum Council and NMFS prepared a draft on Restoring Trust in Government Environmental Assessment for this Through Scientific Integrity and DEPARTMENT OF COMMERCE action pursuant to the National Evidence-Based Policymaking. Federal Environmental Policy Act. This draft National Oceanic and Atmospheric Register (January 27, 2021). can be viewed on NMFS’ website at Administration 13. Fact Sheet: List of Agency Actions for https://www.fisheries.noaa.gov/west- Review (January 21, 2021). coast/laws-and-policies/west-coast- 50 CFR Part 660 Authority: 15 U.S.C. 2601 et seq. region-national-environmental-policy- Dated: March 8, 2021. [RTID 0648–XA797] act-documents. In order to comment on the Environmental Assessment, submit Michal Freedhoff, Fisheries Off West Coast States; all public comments to Lynn Massey at Acting Assistant Administrator, Office of Coastal Pelagic Species Fisheries; [email protected], or Kerry Griffin Chemical Safety and Pollution Prevention. Amendment 18 to the Coastal Pelagic at [email protected]. [FR Doc. 2021–05138 Filed 3–15–21; 8:45 am] Species Fishery Management Plan Instructions: Comments must be BILLING CODE 6560–50–P AGENCY: National Marine Fisheries submitted by the above methods to Service (NMFS), National Oceanic and ensure that the comments are received, Atmospheric Administration (NOAA), documented, and considered by NMFS. Commerce. Comments sent by any other method, to any other address or individual, or ACTION: Announcement of availability of received after the end of the comment fishery management plan amendment; period, may not be considered. All request for comments. comments received are a part of the

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public record and will generally be of NMFS’ overfished notification to the FMP and Council process that limit posted for public viewing on Council that specifies a rebuilding fishing mortality of Pacific sardine. www.regulations.gov without change. timeframe (i.e., Ttarget) within 10 years, As described above, the Magnuson- All personal identifying information except where the biology of the stock or Stevens Act specifies that the time (e.g., name, address, etc.) submitted other environmental conditions dictate period for rebuilding a fishery generally voluntarily by the sender will be otherwise (see Magnuson-Stevens Act should not exceed 10 years unless the publicly accessible. Do not submit section 304(e)(4)(A)(2)). biology of the stock or environmental confidential business information, or In September 2020, the Council conditions dictate otherwise, as is the otherwise sensitive or protected recommended a rebuilding plan strategy case for Pacific sardine. Pacific sardines information. NMFS will accept to NMFS that would maintain the are known for wide swings in anonymous comments (enter ‘‘N/A’’ in existing management framework for the population abundance, and studies the required fields if you wish to remain Pacific sardine fishery. Under the show the species has long experienced anonymous). rebuilding plan, the harvest control boom-bust cycles even in the absence of FOR FURTHER INFORMATION CONTACT: rules and other FMP provisions fishing. Periods of low recruitment Lynn Massey, Sustainable Fisheries currently in place for Pacific sardine success driven by prevailing Division, NMFS, (562) 436–2462, would be maintained. This includes the oceanographic conditions can lead to [email protected]; or Kerry Griffin, harvest guideline control rule, which low population abundance over Pacific Fishery Management Council, requires that the primary directed extended periods of time. Because (503) 820–2409, [email protected]. fishery for Pacific sardine be closed environmental conditions represent the primary constraint on rebuilding Pacific SUPPLEMENTARY INFORMATION: The when the biomass is at or below 150,000 mt and restrictions on incidental sardine, the projected time for coastal pelagic species (CPS) fishery in rebuilding, is 14 years (i.e., T ). This the U.S. exclusive economic zone off the landings of Pacific sardine in other CPS target fisheries, including an automatic Ttarget was determined to be the shortest West Coast is managed under the CPS time possible to rebuild the stock, taking Fishery Management Plan (FMP). The reduction in allowable incidental landings when the biomass is below into account the biology of the species, Pacific Fishery Management Council current environmental conditions, and (Council) developed the CPS FMP 50,000 mt. The rebuilding plan would also maintain the Council’s annual the needs of fishing communities. For pursuant to the Magnuson-Stevens more information about how this Fishery Conservation and Management harvest specifications process for Pacific sardine, such that an overfishing limit rebuilding target was determined, see Act (Magnuson-Stevens Act), 16 U.S.C. the Environmental Assessment at and acceptable biological catch are 1801 et seq. The Secretary of Commerce https://www.fisheries.noaa.gov/west- calculated annually based on an approved the CPS FMP and coast/laws-and-policies/west-coast- estimate of that year’s biomass from implemented the provisions of the plan region-national-environmental-policy- annual stock assessments and their through regulations at 50 CFR part 660, act-documents. subpart I. Species managed under the respective control rules in the FMP (that Amendment 18 would expand CPS FMP include Pacific sardine, have been approved by the Scientific Section 4.5 of the CPS FMP to include Pacific mackerel, jack mackerel, and Statistical Committee to prevent the proposed rebuilding plan for Pacific northern anchovy, market squid, and overfishing). In addition to the harvest sardine. There are no implementing krill. control rules prescribed by the CPS regulations associated with Amendment The Magnuson-Stevens Act requires FMP, the rebuilding plan would allow 18, therefore NMFS will not promulgate each regional fishery management the Council to maintain their ability to proposed and final rules to implement council to submit any amendment to an annually adjust the incidental harvest this amendment. FMP to NMFS for review and approval, percentages or other accountability Public comments on Amendment 18 disapproval, or partial approval. The measures for the various sectors based must be received by May 17, 2021. Magnuson-Stevens Act also requires on new information from the previous Public comments on the associated EA that NMFS, upon receiving an year or changes in fishery dynamics, if for Amendment 18 must be received by amendment to an FMP, publish necessary. Although this framework May 17, 2021. All comments received notification in the Federal Register that would maintain the current by the end of the comment period on the amendment is available for public management strategy, this management Amendment 18 will be considered in review and comment. NMFS will strategy already severely restricts fishing the Secretary’s decision to approve, consider the public comments received and will continue to do so until the disapprove, or partially approve this during the comment period described stock is rebuilt. amendment. To be considered in this above in determining whether to Current fishing mortality is not decision, comments must be received by approve, disapprove, or partially considered to be the primary close of business on the last day of the approve Amendment 18. constraining factor or rebuilding Pacific comment period; that does not mean NMFS declared the northern sardine. The primary directed fishery postmarked or otherwise transmitted by subpopulation of Pacific sardine for Pacific sardine has been closed since that date. NMFS will respond to any (hereafter, Pacific sardine) overfished in 2015 when the stock’s biomass dropped substantive comments received by the June 2019. This determination was below the 150,000 mt threshold in the end of the comment period on based on the results of an April 2019 CPS FMP for allowing a primary Amendment 18 in a subsequent Federal stock assessment, which indicated that directed fishery. This closure of the Register document. the biomass of Pacific sardine had primary directed fishery, which took Authority: 16 U.S.C. 1801 et seq. dropped below the overfished threshold place 4 years prior to the stock of 50,000 metric tons (mt) defined in the dropping, drastically reduced catch of Dated: March 8, 2021. CPS FMP. NMFS notified the Council Pacific sardine and has kept harvest at Jennifer M. Wallace, about the overfished declaration on July very low levels since that time. As such, Acting Director, Office of Sustainable 9, 2019. The Magnuson-Stevens Act the contribution of this rebuilding plan Fisheries, National Marine Fisheries Service. requires that NMFS and the Council to stock recovery would be additional to [FR Doc. 2021–05101 Filed 3–15–21; 8:45 am] prepare a rebuilding plan within 2 years measures already in place via the CPS BILLING CODE 3510–22–P

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Notices Federal Register Vol. 86, No. 49

Tuesday, March 16, 2021

This section of the FEDERAL REGISTER is being asked to seek public input climate-smart agriculture and forestry contains documents other than rules or regarding USDA’s climate strategy. Part strategies? proposed rules that are applicable to the II Section 216(b) of this Executive Order E. How can USDA encourage the public. Notices of hearings and investigations, directs the Secretary of Agriculture to, voluntary adoption of climate-smart committee meetings, agency decisions and ‘‘collect input from Tribes, farmers, agricultural and forestry practices in an rulings, delegations of authority, filing of efficient way, where the benefits accrue petitions and applications and agency ranchers, forest owners, conservation statements of organization and functions are groups, firefighters, and other to producers? stakeholders on how to best use examples of documents appearing in this 2. Biofuels, Wood and Other Department of Agriculture programs, section. Bioproducts, and Renewable Energy funding and financing capacities, and Questions other authorities, and how to encourage DEPARTMENT OF AGRICULTURE the voluntary adoption of climate-smart A. How should USDA utilize agricultural and forestry practices that programs, funding and financing [Docket Number: USDA–2021–0003] decrease wildfire risk fueled by climate capacities, and other authorities to Notice of Request for Public Comment change and result in additional, encourage greater use of biofuels for on the Executive Order on Tackling the measurable, and verifiable carbon transportation, sustainable bioproducts Climate Crisis at Home and Abroad reductions and sequestration and that (including wood products), and source sustainable bioproducts and renewable energy? AGENCY: Office of the Chief Economist, fuels.’’ This public input will be B. How can incorporating climate- U.S. Department of Agriculture. considered as USDA prepares smart agriculture and forestry into ACTION: Request for public comment. recommendations to expand climate- biofuel and bioproducts feedstock smart agriculture and forestry practices production systems support rural SUMMARY: On January 27, 2021, and systems. The feedback requested economies and green jobs? President Biden issued an Executive through this Executive Order is far- C. How can USDA support adoption Order on Tackling the Climate Crisis at reaching; it encompasses the best use of and production of other renewable Home and Abroad. This Executive USDA programs, funding and financing energy technologies in rural America, Order laid out a series of actions for capabilities, authorities, and such as renewable natural gas from Federal Agencies to take regarding encouragement of voluntary livestock, biomass power, solar, and climate change mitigation and conservation adoption. wind? resilience, including directing the USDA currently requests public 3. Addressing Catastrophic Wildfire Secretary of Agriculture to collect comment on: stakeholder input on a climate-smart Questions agriculture and forestry strategy. As part 1. Climate-Smart Agriculture and A. How should USDA utilize of this process, the U.S. Department of Forestry Questions programs, funding and financing Agriculture (USDA) is seeking input A. How should USDA utilize capacities, and other authorities to from the public to ensure that relevant programs, funding and financing decrease wildfire risk fueled by climate information is considered. USDA is capacities, and other authorities, to change? interested in your comments in encourage the voluntary adoption of B. How can the various USDA response to the topics, categories and climate-smart agricultural and forestry agencies work more cohesively across questions shown in the SUPPLEMENTARY practices on working farms, ranches, programs to advance climate-smart INFORMATION section of this notice. and forest lands? forestry practices and reduce the risk of DATES: Interested persons are invited to 1. How can USDA leverage existing wildfire on all lands? submit comments on or before 11:59 policies and programs to encourage C. What additional data, tools and p.m. Eastern Time April 29, 2021. voluntary adoption of agricultural research are needed for USDA to practices that sequester carbon, reduce effectively reduce wildfire risk and ADDRESSES: Comments may be manage Federal lands for carbon? submitted online via the Federal greenhouse gas emissions, and ensure D. What role should partners and eRulemaking Portal. Go to http:// resiliency to climate change? 2. What new strategies should USDA stakeholders play, including State, local www.regulations.gov and search for the explore to encourage voluntary adoption and Tribal governments, related to Docket No. USDA–2021–0003. Follow of climate-smart agriculture and forestry addressing wildfires? the online instructions for submitting practices? comments. All comments received will B. How can partners and stakeholders, 4. Environmental Justice and be posted without change and publicly including State, local and Tribal Disadvantaged Communities Questions available on www.regulations.gov. governments and the private sector, A. How can USDA ensure that FOR FURTHER INFORMATION CONTACT: work with USDA in advancing climate- programs, funding and financing William Hohenstein, Director, USDA smart agricultural and forestry capacities, and other authorities used to Office of Energy and Environmental practices? advance climate-smart agriculture and Policy, Phone: 202–720–0450; Email: C. How can USDA help support forestry practices are available to all [email protected]. emerging markets for carbon and landowners, producers, and SUPPLEMENTARY INFORMATION: Through greenhouse gases where agriculture and communities? the Executive Order on Tackling the forestry can supply carbon benefits? B. How can USDA provide technical Climate Crisis at Home and Abroad, the D. What data, tools, and research are assistance, outreach, and other U.S. Department of Agriculture (USDA) needed for USDA to effectively carry out assistance necessary to ensure that all

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producers, landowners, and Supporting documents and any in any NAHMS study is voluntary, and communities can participate in USDA comments we receive on this docket all data are confidential. programs, funding, and other authorities may be viewed at regulations.gov or in APHIS plans to conduct the On-Farm related to climate-smart agriculture and our reading room, which is located in Monitoring of Antimicrobial Use and forestry practices? Room 1620 of the USDA South Resistance in U.S. Broiler Production C. How can USDA ensure that Building, 14th Street and Independence Study as part of an ongoing series of programs, funding and financing Avenue SW, Washington, DC. Normal NAHMS studies on the U.S. livestock, capabilities, and other authorities reading room hours are 8 a.m. to 4:30 poultry, and aquaculture populations. related to climate-smart agriculture and p.m., Monday through Friday, except This study will support the following forestry practices are implemented holidays. To be sure someone is there to objectives: (1) Measure and track trends equitably? help you, please call (202) 799–7039 in antimicrobial use (AMU) and Please provide information including before coming. antimicrobial resistance (AMR) in citations and/or contact details for the FOR FURTHER INFORMATION CONTACT: For broiler complexes within participating correspondent when submitting information on the NAHMS On-Farm companies over time; (2) Evaluate the comments to Regulations.gov. Monitoring of Antimicrobial Use and relationship between AMU patterns and AMR measured in select bacterial Seth Meyer, Resistance in U.S. Broiler Production Study, contact Mr. Bill Kelley, Assistant species collected; and (3) Quantify Chief Economist, Office of the Chief antimicrobial resistance genes in the Economist. Director, Program Coordination and Implementation, Center for litter of sampled broiler farms and [FR Doc. 2021–05287 Filed 3–15–21; 8:45 am] Epidemiology and Animal Health, VS, examine the relationship between these BILLING CODE 3410–GL–P 2150 Centre Avenue, Building B, Fort quantities and antimicrobial use patterns. Collins, CO 80524; (970) 494–7270. For This study is an information information on the information DEPARTMENT OF AGRICULTURE collection conducted by APHIS through collection process, contact Mr. Joseph a cooperative agreement with the Animal and Plant Health Inspection Moxey, APHIS Information Collection University of . The university Service Coordinator, at (301) 851–2483; completed previous work for APHIS [email protected]. under a different cooperative agreement [Docket No. APHIS–2021–0008] SUPPLEMENTARY INFORMATION: in which APHIS received reports and Title: National Animal Health completed analyses but not farm-level Notice of Request for Approval of an Monitoring System; On-Farm data. APHIS now seeks access to farm- Information Collection; National Monitoring of Antimicrobial Use and level data that is presented in a manner Animal Health Monitoring System; On- Resistance in U.S. Broiler Production in which the farms are not identified. Farm Monitoring of Antimicrobial Use Study. This study will monitor U.S. broiler and Resistance in U.S. Broiler OMB Control Number: 0579–XXXX. operations for AMU, AMR, animal Production Study Type of Request: Approval of a new health and production practices, and the information collection. AGENCY: Animal and Plant Health relationship between AMU, AMR, Inspection Service, USDA. Abstract: Under the Animal Health animal health, production practices, and Protection Act (7 U.S.C. 8301 et seq.), changes over time. We will collect ACTION: New information collection; the Secretary of the U.S. Department of annual informed consent forms from comment request. Agriculture (USDA) is authorized to producers, quarterly survey data, and SUMMARY: In accordance with the protect the health of the livestock, litter samples from the same poultry Paperwork Reduction Act of 1995, this poultry, and aquaculture populations in complexes, and examine AMR in notice announces the Animal and Plant the United States by preventing the bacteria such as Salmonella and Health Inspection Service’s intention to introduction and interstate spread of Campylobacter. This study meets request approval of a new information serious diseases and pests of livestock, objectives for both the U.S. National collection associated with the National poultry, and aquaculture, and for Action Plan for Combating Antibiotic Animal Health Monitoring System’s On- eradicating such diseases and pests from Resistance (2015) and the USDA AMR Farm Monitoring of Antimicrobial Use the United States, when feasible. Within National Action Plan (2013). and Resistance in U.S. Broiler the USDA, this authority and mission is Additionally, this information is an Production Study. delegated to the Animal and Plant essential component in accomplishing Health Inspection Service (APHIS). one of APHIS’ strategic goals, which is DATES: We will consider all comments In connection with this mission, to safeguard American agriculture. that we receive on or before May 17, APHIS operates the National Animal APHIS and the University of 2021. Health Monitoring System (NAHMS), Minnesota will analyze and organize the ADDRESSES: You may submit comments which collects on a national basis, information into one or more by either of the following methods: statistically valid and scientifically descriptive reports and scientific • Federal eRulemaking Portal: Go to sound data on the prevalence and manuscripts, and for important or www.regulations.gov. Enter APHIS– economic importance of livestock, special topics, APHIS will develop and 2021–0008 in the Search field. Select poultry, and aquaculture disease risk disseminate targeted information sheets the Documents tab, then select the factors. APHIS is the only agency to producers, stakeholders, Comment button in the list of responsible for collecting data on academicians, veterinarians, and any documents. livestock, poultry, and aquaculture other interested parties. This • Postal Mail/Commercial Delivery: health. NAHMS’ studies have evolved information benefits the poultry Send your comment to Docket No. into a collaborative industry and industry by supplying scientific APHIS–2021–0008, Regulatory Analysis Government initiative to help determine estimates of AMU and stewardship by and Development, PPD, APHIS, Station the most effective means of preventing poultry producers and evaluation of the 3A–03.8, 4700 River Road, Unit 118, and controlling diseases of livestock, influence of these and other Riverdale, MD 20737–1238. poultry, and aquaculture. Participation management practices on AMR.

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We are asking the Office of DEPARTMENT OF COMMERCE FOR FURTHER INFORMATION CONTACT: Management and Budget (OMB) to Requests for additional information or approve our use of these information Census Bureau specific questions related to collection collection activities for 3 years. activities should be directed to Michael Agency Information Collection A. DeFrank, Chief, Management The purpose of this notice is to solicit Activities; Submission to the Office of Services Branch. Mr. DeFrank can be comments from the public (as well as Management and Budget (OMB) for reached by telephone on 301–763–2864 affected agencies) concerning our Review and Approval; Comment or by email at Michael.A.DeFrank@ information collection. These comments Request; Form BC–170, U.S. Census census.gov. will help us: Employment Application and Form SUPPLEMENTARY INFORMATION: (1) Evaluate whether the collection of BC–171, Additional Applicant information is necessary for the proper Information I. Abstract performance of the functions of the AGENCY: Census Bureau, Commerce. The U.S. Census Bureau is requesting Agency, including whether the ACTION: Notice of information collection, to continue to use Form BC–170, U.S. information will have practical utility; request for comment. Census Employment Application and (2) Evaluate the accuracy of our Form BC–171, Additional Applicant SUMMARY: estimate of the burden of the collection The Department of Information. There are no changes Commerce, in accordance with the requested to these forms at this time. of information, including the validity of Paperwork Reduction Act (PRA) of The Census Bureau uses these forms the methodology and assumptions used; 1995, invites the general public and to collect applicant information. (3) Enhance the quality, utility, and other Federal agencies to comment on Selecting officials use Form BC–170 as clarity of the information to be proposed, and continuing information part of the recruitment, assessment, and collected; and collections, which helps us assess the selection process for potential field (4) Minimize the burden of the impact of our information collection employees. The form was used for the collection of information on those who requirements and minimize the public’s Decennial Census and will continue to are to respond, through use, as reporting burden. The purpose of this be used for Current/Permanent Surveys, appropriate, of automated, electronic, notice is to allow for 60 days of public upcoming Special Censuses as well as Decennial Census tests. Applicants mechanical, and other collection comment on the reinstatement, without applying for Current/Permanent Survey technologies; e.g., permitting electronic change, of Form BC–170, U.S. Census Employment Application and Form BC– positions will submit a paper version of submission of responses. 171, Additional Applicant Information, these forms at no cost to the applicant. Estimate of burden: The public prior to the submission of the An online version of these forms will be burden for this collection of information information collection request (ICR) to used for Special Censuses and is estimated to average 1.5 hours per OMB for approval. Decennial Census tests. response. DATES: To ensure consideration, In 2018, Form BC–171, Additional Respondents: Broiler producers. comments regarding this proposed Applicant Information replaced Equal Employment Opportunity Commission Estimated annual number of information collection must be received on or before May 17, 2021. (EEOC) common use from 3046–0046, respondents: 30. Demographic Information on Applicants ADDRESSES: Interested persons are Estimated annual number of invited to submit written comments by for Federal Employment to collect responses per respondent: 20. email to Michael DeFrank, Chief, voluntary applicant data and is not used Estimated annual number of Management Services Branch at in the selection process. The Census Bureau intends for [email protected]. responses: 588. applicants to access, complete, and Estimated total annual burden on Please reference Form BC–170, U.S. Census Employment Application and submit both the BC–170 and BC–171 to respondents: 866 hours. (Due to Form BC–171, Additional Applicant human resources staff via an online averaging, the total annual burden hours Information in the subject line of your applicant system for census jobs. The may not equal the product of the annual comments. You may also submit Census Bureau will continue to use a number of responses multiplied by the comments, identified by Docket Number paper version of the BC–170 and BC– reporting burden per response.) USBC–2021–0006, to the Federal e- 171 forms for applicants to complete All responses to this notice will be Rulemaking Portal: http:// and submit to the Regional Office for the Field Representative, Field Supervisor, summarized and included in the request www.regulations.gov. All comments and temporary clerical positions until for OMB approval. All comments will received are part of the public record. an online version is available for this also become a matter of public record. No comments will be posted to http:// www.regulations.gov for public viewing group of applicants. Lastly, the online Done in Washington, DC, this 10th day of until after the comment period has version, paper forms and the online PDF March 2021. closed. Comments will generally be format forms will be available in Mark Davidson, posted without change. All Personally Spanish for Puerto Rico. Acting Administrator, Animal and Plant Identifiable Information (for example, II. Method of Collection Health Inspection Service. name and address) voluntarily All interested applicants submit the [FR Doc. 2021–05360 Filed 3–15–21; 8:45 am] submitted by the commenter may be forms as described above. BILLING CODE 3410–34–P publicly accessible. Do not submit Confidential Business Information or III. Data otherwise sensitive or protected OMB Control Number: 0607–0139. information. You may submit Form Number(s): BC–170 and BC– attachments to electronic comments in 171. Microsoft Word, Excel, or Adobe PDF Type of Review: Regular submission, file formats. Request for an Extension, without

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Change, of a Currently Approved cannot guarantee that we will be able to For further information, contact Collection. do so. Christopher Wedderburn at [email protected]. Affected Public: Individuals or Sheleen Dumas, households. Department PRA Clearance Officer, Office of Dated: March 10, 2021. Estimated Number of Respondents: the Chief Information Officer, Commerce Andrew McGilvray, 12,000 persons (Note that in non- Department. Executive Secretary. Decennial periods of data collection [FR Doc. 2021–05419 Filed 3–15–21; 8:45 am] [FR Doc. 2021–05398 Filed 3–15–21; 8:45 am] after 2020, the estimated number of BILLING CODE 3510–07–P BILLING CODE 3510–DS–P respondents annually is approximately 12,000 persons). DEPARTMENT OF COMMERCE DEPARTMENT OF COMMERCE Estimated Time per Response: 20 minutes (Note that this is based on Foreign-Trade Zones Board International Trade Administration calculations that determined 15 minutes [B–19–2021] [C–570–138] for completing the BC–170 and 5 minutes for completing the BC–171. The Foreign-Trade Zone (FTZ) 59—Lincoln, Pentafluoroethane (R–125) from the combined total is 20 minutes for ; Notification of Proposed People’s Republic of China: applicants completing both forms). Production Activity; Zoetis Services, Postponement of Preliminary LLC; (Pharmaceutical Products); Determination in the Countervailing Estimated Total Annual Burden Lincoln, Nebraska Hours: 4,000 annual hours on average. Duty Investigation Zoetis Services, LLC (Zoetis) Estimated Total Annual Cost to AGENCY: Enforcement and Compliance, submitted a notification of proposed Public: $0. International Trade Administration, production activity to the FTZ Board for Department of Commerce. Respondent’s Obligation: Voluntary. its facility in Lincoln, Nebraska. The Legal Authority: Title 13 U.S.C., notification conforming to the DATES: Applicable March 16, 2021. Chapter 1, Subchapter II, Section 23 a requirements of the regulations of the FOR FURTHER INFORMATION CONTACT: and c.; Title 5 U.S.C., Part II, Chapter 13; FTZ Board (15 CFR 400.22) was Joshua Tucker at (202) 482–2044 or Title 5 U.S.C. part III, Chapter 33, received on March 2, 2021. Adam Simons at (202) 482–6172, AD/ Subchapter 1, Section 3301 and 3320. The Zoetis facility is located within CVD Operations Office II, Enforcement Subzone 59E. The facility is used for the and Compliance, International Trade IV. Request for Comments production of pharmaceuticals for the Administration, U.S. Department of animal pharmaceutical industry. Commerce, 1401 Constitution Avenue We are soliciting public comments to Pursuant to 15 CFR 400.14(b), FTZ NW, Washington, DC 20230. permit the Department/Bureau to: (a) activity would be limited to the specific SUPPLEMENTARY INFORMATION: Evaluate whether the proposed foreign-status material and specific information collection is necessary for finished product described in the Background the proper functions of the Department, submitted notification (as described On February 1, 2021, the Department including whether the information will below) and subsequently authorized by of Commerce (Commerce) initiated a have practical utility; (b) Evaluate the the FTZ Board. countervailing duty (CVD) investigation Production under FTZ procedures accuracy of our estimate of the time and of imports of pentafluoroethane (R–125) could exempt Zoetis from customs duty cost burden for this proposed collection, from the People’s Republic of China payments on the foreign-status including the validity of the (China).1 Currently, the preliminary components used in export production. methodology and assumptions used; (c) determination is due no later than April On its domestic sales, for the foreign- Evaluate ways to enhance the quality, 7, 2021. utility, and clarity of the information to status material noted below, Zoetis be collected; and (d) Minimize the would be able to choose the duty rates Postponement of Preliminary reporting burden on those who are to during customs entry procedures that Determination applies to Simparica® (Sarolaner) respond, including the use of automated Section 703(b)(1) of the Tariff Act of chewable tablets (duty-free). Zoetis collection techniques or other forms of 1930, as amended (the Act), requires would be able to avoid duty on foreign- information technology. Commerce to issue the preliminary status components which become scrap/ determination in a CVD investigation Comments that you submit in waste. Customs duties also could within 65 days after the date on which response to this notice are a matter of possibly be deferred or reduced on Commerce initiated the investigation. public record. We will include, or foreign-status production equipment. However, section 703(c)(1) of the Act The material sourced from abroad is summarize, each comment in our permits Commerce to postpone the sarolaner spray dried dispersion (duty request to OMB to approve this ICR. preliminary determination until no later rate 6.5%). Before including your address, phone than 130 days after the date on which number, email address, or other Public comment is invited from interested parties. Submissions shall be Commerce initiated the investigation if: personal identifying information in your (A) The petitioner makes a timely comment, you should be aware that addressed to the Board’s Executive Secretary and sent to: [email protected]. The request for a postponement; or (B) your entire comment—including your Commerce concludes that the parties personal identifying information—may closing period for their receipt is April 26, 2021. concerned are cooperating, that the be made publicly available at any time. A copy of the notification will be investigation is extraordinarily While you may ask us in your comment available for public inspection in the 1 to withhold your personal identifying ‘‘Reading Room’’ section of the Board’s See Pentafluoroethane (R–125) From the information from public review, we People’s Republic of China: Initiation of website, which is accessible via Countervailing Duty Investigation, 86 FR 8589 www.trade.gov/ftz. (February 8, 2021).

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complicated, and that additional time is DEPARTMENT OF COMMERCE DEPARTMENT OF COMMERCE necessary to make a preliminary determination. Under 19 CFR International Trade Administration National Oceanic and Atmospheric 351.205(e), the petitioner must submit a Administration request for postponement 25 days or [A–570–062] [Docket No. 210308–0048; RTID 0648– more before the scheduled date of the XW032] preliminary determination and must Cast Iron Soil Pipe Fittings From the state the reasons for the request. People’s Republic of China: Final Endangered and Threatened Wildlife; Commerce will grant the request unless Results of Antidumping Duty 90-Day Finding on a Petition To List it finds compelling reasons to deny the Administrative Review, 2018–2019; Southern Oregon and Northern request. Correction California Coastal Spring-Run Chinook Salmon as Threatened or Endangered On March 2, 2021, the petitioner 2 AGENCY: Enforcement and Compliance, Under the Endangered Species Act submitted a timely request that International Trade Administration, Commerce postpone the preliminary AGENCY: National Marine Fisheries Department of Commerce. CVD determination.3 The petitioner Service (NMFS), National Oceanic and stated that it requested postponement so ACTION: Notice; correction. Atmospheric Administration (NOAA), that Commerce may sufficiently review Department of Commerce. all questionnaire responses and new SUMMARY: The Department of Commerce ACTION: 90-Day petition finding, request factual information to permit a thorough (Commerce) published a notice in the for information, and initiation of status investigation and the calculation of Federal Register of February 9, 2021, review. accurate subsidy rates.4 concerning the final results of the SUMMARY: We, NMFS, announce a 90- administrative review of cast iron soil In accordance with 19 CFR day finding on a petition to list pipe fittings (soil pipe fittings) from the 351.205(e), the petitioner has stated the Southern Oregon and Northern reasons for requesting a postponement People’s Republic of China (China) for California Coastal (SONCC) spring-run of the preliminary determination, and the period of review of February 20, Chinook salmon (Oncorhynchus Commerce finds no compelling reason 2018, through July 31, 2019. The notice tshawytscha) as a threatened or to deny the request. Therefore, in contained an incorrect spelling of a endangered Evolutionarily Significant accordance with section 703(c)(1)(A) of company name. Unit (ESU) under the Endangered the Act, Commerce is postponing the FOR FURTHER INFORMATION CONTACT: Species Act (ESA) and to designate deadline for the preliminary Samantha Kinney, AD/CVD Operations, critical habitat concurrently with the determination to no later than 130 days Office VIII, Enforcement and listing. We find that the petition after the date on which this Compliance, International Trade presents substantial scientific and investigation was initiated, i.e., June 11, Administration, Department of commercial information indicating the 2021. Pursuant to section 705(a)(1) of Commerce, 14th Street and Constitution petitioned action may be warranted. We will conduct a status review of SONCC the Act and 19 CFR 351.210(b)(1), the Avenue NW, Washington, DC 20230; spring-run Chinook salmon to deadline for the final determination of telephone: (202) 482–2285. this investigation will continue to be 75 determine whether the petitioned action SUPPLEMENTARY INFORMATION: days after the date of the preliminary is warranted. To ensure that the status review is comprehensive, we are determination. Correction soliciting scientific and commercial This notice is issued and published In the Federal Register of February 9, information pertaining to this species pursuant to section 703(c)(2) of the Act 2021, in FR Doc. 2021–02597, on page from any interested party. and 19 CFR 351.205(f)(1). 8763, in ‘‘The China-Wide Entity’’ DATES: Scientific and commercial Dated: March 10, 2021. section, correct the last company name information pertinent to the petitioned Christian Marsh, to read ‘‘Yangcheng Country Huawang action must be received by May 17, Acting Assistant Secretary for Enforcement Universal.’’ 2021. and Compliance. This correction to the Final Results is ADDRESSES: You may submit data and [FR Doc. 2021–05400 Filed 3–15–21; 8:45 am] published in accordance with sections information relevant to our review of the status of Southern Oregon and BILLING CODE 3510–DS–P 751(a)(1) and 777(i)(1) of the Tariff Act of 1930, as amended. Northern California Coastal spring-run Chinook salmon, identified by NOAA– Dated: March 10, 2021. NMFS–2020–0079, by either of the Christian Marsh, following methods: Acting Assistant Secretary for Enforcement • Electronic Submission: Submit all and Compliance. electronic public comments via the [FR Doc. 2021–05399 Filed 3–15–21; 8:45 am] Federal eRulemaking Portal. Go to BILLING CODE 3510–DS–P https://www.regulations.gov and enter NOAA–NMFS–2020–0079 in the Search box. Click on the ‘‘Comment’’ icon,

2 complete the required fields, and enter The petitioner is Honeywell International, Inc. or attach your comments. 3 See Petitioner’s Letter, ‘‘Countervailing Duty • Investigation of Pentafluoroethane (R–125) from the Mail or hand-delivery: Protected People’s Republic of China: Petitioner’s Request to Resources Division, West Coast Region, Postpone the Preliminary Determination,’’ dated NMFS, 1201 NE Lloyd Blvd., Suite March 2, 2021. #1100, Portland, OR 97232. Attn: Gary 4 Id. Rule.

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Instructions: Comments sent by any requirements, as well as basin-level Pacific salmon. A joint NMFS–U.S. Fish other method, to any other address or population status and trends and factors and Wildlife Service (USFWS) (jointly, individual, or received after the end of contributing to the populations’ status. ‘‘the Services’’) policy clarifies the the comment period, may not be Copies of the petition are available as Services’ interpretation of the phrase considered by NMFS. All comments described above (see ADDRESSES, above). ‘‘distinct population segment’’ for the purposes of listing, delisting, and received are a part of the public record ESA Statutory, Regulatory, and Policy reclassifying a species under the ESA and will generally be posted for public Provisions, and Evaluation Framework viewing on https://www.regulations.gov (DPS Policy; 61 FR 4722; February 7, without change. All personal identifying Section 4(b)(3)(A) of the ESA of 1973, 1996). In announcing this policy, the information (e.g., name, address, etc.), as amended (16 U.S.C. 1531 et seq.), Services indicated that the ESU Policy confidential business information, or requires, to the maximum extent for Pacific salmon was consistent with otherwise sensitive information practicable, that within 90 days of the DPS Policy and that NMFS would submitted voluntarily by the sender will receipt of a petition to list a species as continue to use the ESU Policy for be publicly accessible. NMFS will threatened or endangered, the Secretary Pacific salmon. accept anonymous comments (enter of Commerce make a finding on whether A species, subspecies, or DPS is ‘‘N/A’’ in the required fields if you wish that petition presents substantial ‘‘endangered’’ if it is in danger of to remain anonymous). scientific or commercial information extinction throughout all or a significant Electronic copies of the petition and indicating that the petitioned action portion of its range, and ‘‘threatened’’ if other materials are available from the may be warranted, and to promptly it is likely to become endangered within NMFS website at publish such finding in the Federal the foreseeable future throughout all or www.fisheries.noaa.gov/rules-and- Register (16 U.S.C. 1533(b)(3)(A)). When a significant portion of its range (ESA regulations. it is found that substantial scientific or sections 3(6) and 3(20), respectively, 16 commercial information in a petition U.S.C. 1532(6) and (20)). Pursuant to the FOR FURTHER INFORMATION CONTACT: Gary indicates the petitioned action may be ESA and our implementing regulations, Rule, NMFS West Coast Region, at warranted (a ‘‘positive 90-day finding’’), we determine whether species are [email protected], (503) 230–5424; or we are required to promptly commence threatened or endangered based on any Heather Austin, NMFS Office of a review of the status of the species one or a combination of the following Protected Resources, at heather.austin@ concerned during which we will five section 4(a)(1) factors: The present noaa.gov, (301) 427–8422. conduct a comprehensive review of the or threatened destruction, modification, SUPPLEMENTARY INFORMATION: best available scientific and commercial or curtailment of habitat or range; Background information. In such cases, we conclude overutilization for commercial, the review with a finding as to whether, recreational, scientific, or educational On May 4, 2020, the Secretary of in fact, the petitioned action is purposes; disease or predation; Commerce received a petition from warranted within 12 months of receipt inadequacy of existing regulatory Richard K. Nawa (hereafter, the of the petition. Because the finding at mechanisms to address identified Petitioner) to identify SONCC spring- the 12-month stage is based on a more threats; or any other natural or run Chinook salmon as a separate ESU thorough review of the available manmade factors affecting the species’ and list the ESU as threatened or information, as compared to the narrow existence (16 U.S.C. 1533(a)(1), 50 CFR endangered under the ESA. Previously, scope of review at the 90-day stage, a 424.11(c)). in 1999, we identified the SONCC positive 90-day finding does not ESA-implementing regulations issued Chinook salmon ESU as including both prejudge the outcome of the status jointly by NMFS and USFWS (50 CFR spring-run and fall-run Chinook salmon review. 424.14(h)(1)(i)) define ‘‘substantial and determined that the ESU did not Under the ESA, a listing scientific or commercial information’’ in warrant listing as threatened or determination may address a species, the context of reviewing a petition to endangered under the ESA (64 FR which is defined to also include list, delist, or reclassify a species as 50394; September 16, 1999). The subspecies and, for any vertebrate ‘‘credible scientific or commercial Petitioner is requesting that SONCC species, any distinct population information in support of the petition’s spring-run Chinook salmon be segment (DPS) that interbreeds when claims such that a reasonable person considered as a separate ESU and listed mature (16 U.S.C. 1532(16)). In 1991, we conducting an impartial scientific as threatened or endangered. The issued the Policy on Applying the review would conclude that the action Petitioner asserts that new research into Definition of Species Under the proposed in the petition may be the genomic basis for premature Endangered Species Act to Pacific warranted.’’ Conclusions drawn in the migration in salmonids demonstrates Salmon (ESU Policy; 56 FR 58612; petition without the support of credible that significant genetic differences November 20, 1991), which explains scientific or commercial information underlie the spring- and fall-run life that Pacific salmon populations will be will not be considered ‘‘substantial history types, and that the unique considered a DPS, and hence a information.’’ In reaching the initial (90- evolutionary lineage of spring-run ‘‘species’’ under the ESA, if it represents day) finding on the petition, we will Chinook salmon warrants their listing as an ‘‘evolutionarily significant unit’’ of consider the information described in a separate ESU. The Petitioner also the biological species. The two criteria sections 50 CFR 424.14(c), (d), and (g) requests the designation of critical for delineating an ESU are: (1) It is (if applicable). habitat for SONCC spring-run Chinook substantially reproductively isolated Our determination as to whether the salmon concurrent with ESA listing. from other conspecific populations, and petition provides substantial scientific The petition includes an overview of (2) it represents an important or commercial information indicating new research into the genomic basis for component in the evolutionary legacy of that the petitioned action may be premature migration in salmonids, as the species. The ESU Policy was used to warranted will depend in part on the well as general biological information define the SONCC Chinook salmon ESU degree to which the petition includes about SONCC spring-run Chinook in 1999 (64 FR 50394; September 16, the following types of information: (1) salmon including their distribution and 1999), and we use it exclusively for Information on current population range, life history characteristics, habitat defining distinct population segments of status and trends and estimates of

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current population sizes and as a final listing determination, 90-day productivity, spatial structure, age distributions, both in captivity and the not-substantial finding, or 12-month structure, sex ratio, diversity, current wild, if available; (2) identification of not-warranted finding—a petitioned and historical range, habitat integrity or the factors under section 4(a)(1) of the action will generally not be considered fragmentation), and the potential ESA that may affect the species and to present substantial scientific and contribution of identified demographic where these factors are acting upon the commercial information indicating that risks to extinction risk for the species. species; (3) whether and to what extent the action may be warranted unless the We then evaluate the potential links any or all of the factors alone or in petition provides new information or between these demographic risks and combination identified in section 4(a)(1) analyses not previously considered. the causative impacts and threats of the ESA may cause the species to be At the 90-day finding stage, we do not identified in section 4(a)(1). an endangered species or threatened conduct additional research, and we do Information presented on impacts or species (i.e., the species is currently in not solicit information from parties threats should be specific to the species danger of extinction or is likely to outside the agency to help us in and should reasonably suggest that one become so within the foreseeable evaluating the petition. We will accept or more of these factors may be future), and, if so, how high in the petitioner’s sources and operative threats that act or have acted magnitude and how imminent the characterizations of the information on the species to the point that it may threats to the species and its habitat are; presented if they appear to be based on warrant protection under the ESA. (4) information on adequacy of accepted scientific principles, unless we Broad statements about generalized regulatory protections and effectiveness have specific information in our files threats to the species, or identification of conservation activities by states as that indicates the petition’s information of factors that could negatively impact well as other parties, that have been is incorrect, unreliable, obsolete, or a species, alone, do not constitute initiated or that are ongoing, that may otherwise irrelevant to the requested substantial information indicating that protect the species or its habitat; and (5) action. Information that is susceptible to listing may be warranted. We look for a complete, balanced representation of more than one interpretation or that is information indicating that not only is the relevant facts, including information contradicted by other available the particular species exposed to a that may contradict claims in the information will not be dismissed at the factor, but that the species may be petition. See 50 CFR 424.14(d). 90-day finding stage, so long as it is responding in a negative fashion; then If the petitioner provides reliable and a reasonable person we assess the potential significance of supplemental information before the conducting an impartial scientific that negative response. initial finding is made and states that it review would conclude it supports the is part of the petition, the new petitioner’s assertions. In other words, Many petitions identify risk information, along with the previously conclusive information indicating that classifications made by submitted information, is treated as a the species may meet the ESA’s nongovernmental organizations, such as new petition that supersedes the requirements for listing is not required the International Union on the original petition, and the statutory to make a positive 90-day finding. We Conservation of Nature (IUCN), the timeframes will begin when such will not conclude that a lack of specific American Fisheries Society, or supplemental information is received. information alone necessitates a NatureServe, as evidence of extinction See 50 CFR 424.14(g). negative 90-day finding if a reasonable risk for a species. Risk classifications by We may also consider information person conducting an impartial such organizations or made under other readily available at the time the scientific review would conclude that Federal or state statutes may be determination is made. We are not the unknown information itself suggests informative, but such classification required to consider any supporting the species may be at risk of extinction alone may not provide the rationale for materials cited by the petitioner if the presently or within the foreseeable a positive 90-day finding under the petitioner does not provide electronic or future. ESA. For example, as explained by hard copies, to the extent permitted by To make a 90-day finding on a NatureServe, their assessments of a U.S. copyright law, or appropriate petition to list a species, we evaluate species’ conservation status do ‘‘not excerpts or quotations from those whether the petition presents constitute a recommendation by materials (e.g., publications, maps, substantial scientific or commercial NatureServe for listing under the U.S. reports, letters from authorities). See 50 information indicating the subject Endangered Species Act’’ because CFR 424.14(c)(6). species may be either threatened or NatureServe assessments ‘‘have The ‘‘substantial scientific or endangered, as defined by the ESA. different criteria, evidence commercial information’’ standard must First, we evaluate whether the requirements, purposes and taxonomic be applied in light of any prior reviews information presented in the petition, in coverage than government lists of or findings we have made on the listing light of the information readily available endangered and threatened species, and status of the species that is the subject in our files, indicates that the petitioned therefore these two types of lists should of the petition. Where we have already entity constitutes a ‘‘species’’ eligible for not be expected to coincide’’ (https:// conducted a finding on, or review of, listing under the ESA. Next, we evaluate explorer.natureserve.org/ the listing status of that species whether the information indicates that AboutTheData/DataTypes/Conservation (whether in response to a petition or on the species faces an extinction risk such StatusCategories). Additionally, species our own initiative), we will evaluate any that listing, delisting, or reclassification classifications under IUCN and the ESA petition received thereafter seeking to may be warranted; this may be indicated are not equivalent; data standards, list, delist, or reclassify that species to in information expressly discussing the criteria used to evaluate species, and determine whether a reasonable person species’ status and trends, or in treatment of uncertainty are also not conducting an impartial scientific information describing impacts and necessarily the same. Thus, when a review would conclude that the action threats to the species. We evaluate any petition cites such classifications, we proposed in the petition may be information on specific demographic will evaluate the source of information warranted despite the previous review factors pertinent to evaluating that the classification is based upon in or finding. Where the prior review extinction risk for the species (e.g., light of the standards on extinction risk resulted in a final agency action—such population abundance and trends, and impacts or threats discussed above.

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Previous Federal Actions The Petitioner asserts that spring-run flow regimes due to climate change, and On September 16, 1999, following Chinook salmon in the SONCC Chinook temporal unfavorable conditions in the completion of a status review of west salmon ESU have been sufficiently marine environment. The Petitioner coast Chinook salmon (O. tshawytscha) isolated from fall-run Chinook salmon asserts that diversity in run timing populations in Washington, Oregon, for evolutionarily important differences contributes to the resiliency and Idaho, and California, and an updated to have arisen and been maintained. The stability of salmon populations. At the 90-day finding stage, we also status review for four Chinook salmon Petitioner presents new genetic consider information readily available ESUs, NMFS published a final rule to evidence to suggest the SONCC spring- in our files. We are currently processing list two Chinook salmon ESUs as run Chinook salmon populations may another petition that cites the same threatened under the Endangered qualify as a separate ESU from the fall- scientific research in support of a Species Act (ESA) (64 FR 50394). In that run populations. The Petitioner asserts that findings from recently published request to identify and list a new coastal final rule, NMFS identified the SONCC spring-run Chinook salmon ESU. On Chinook salmon ESU as composed of articles on the evolutionary basis of premature migration in Pacific salmon September 24, 2019, the Secretary of coastal populations of spring- and fall- Commerce received a petition from the run Chinook salmon from Euchre Creek, (Prince et al., 2017; Davis et al., 2017; Narum et al., 2018; and Thompson et Native Fish Society, Center for Oregon, through the Lower Klamath Biological Diversity, and Umpqua River, California (inclusive) (64 FR al., 2019) indicate that spring-run Chinook salmon in the SONCC ESU Watersheds to identify Oregon Coast 50394). After assessing information spring-run Chinook salmon as a separate concerning Chinook salmon abundance, should be considered a separate ESU. Prince et al. (2017) reported on a survey ESU and list the ESU as threatened or distribution, population trends, and endangered under the ESA. In the risks, and after considering efforts being of genetic variation between mature- and premature-migrating populations of Oregon Coast spring-run Chinook made to protect Chinook salmon, NMFS salmon petition, the petitioners determined in that final rule that the steelhead and Chinook salmon from California, Oregon, and Washington. similarly asserted that findings from Southern Oregon and Northern recently published articles on the California Coastal ESU of Chinook Narum et al. (2018) replicated analysis of loci identified by Prince et al. (2017) evolutionary basis of premature salmon did not warrant listing under the migration in Pacific salmon (Prince et ESA. as associated with premature and mature migratory phenotypes. Davis et al., 2017; Davis et al., 2017; Narum et Evaluation of Petition and Information al. (2017) genotyped Chinook salmon al., 2018; and Thompson et al., 2019) Readily Available in NMFS’ Files within the Siletz River using multiple indicate that spring-run Chinook salmon genetic markers, including neutral in the Oregon Coast ESU should be The petition contains information and considered a separate ESU. On April 13, assertions in support of designating and markers and adaptive loci associated with migratory timing. Thompson et al. 2020, we published notice of a positive listing the spring-run component of the 90-day finding on the petition to list SONCC Chinook salmon ESU as (2019) provide additional information about genetic differentiation between Oregon Coast spring-run Chinook threatened or endangered under the salmon (85 FR 20476) and announced ESA. As discussed above, based on mature- and premature-migrating Chinook salmon in the Rogue River, our intent to conduct a status review. biological, genetic, and ecological We have reviewed the new genetic Oregon, and in the Klamath River, information compiled and reviewed as information and the information California, particularly in response to part of the previous status review of presented by the Petitioner about the anthropogenic changes. The Petitioner Chinook salmon (O. tshawytscha) evolutionary legacy of spring-run populations in Washington, Oregon, suggests that the results of these studies Chinook salmon in the SONCC ESU. Idaho, and California (Myers et al., indicate that premature migration (e.g., Based on information provided by the 1998) and the status review update for spring-run Chinook salmon) arose from Petitioner, as well as information deferred ESUs of West Coast Chinook a single evolutionary event within the readily available in our files, we find Salmon (NMFS, 1999), we included all species and, if lost, is not likely to re- that a reasonable person would spring-run and fall-run Chinook salmon evolve in time frames relevant to conclude that SONCC spring-run populations from Euchre Creek, Oregon, conservation planning. Chinook salmon may qualify as an ESU through the Lower Klamath River, The Petitioner also asserts that the pursuant to our ESU Policy. California, in the SONCC Chinook Chinook salmon spring-run life history salmon ESU (64 FR 50394; September represents an important component of SONCC Spring-Run Chinook Salmon 16, 1999). While run-timing was the evolutionary legacy of the species. Status and Trends recognized as having a heritable basis, In support of this assertion, the The Petitioner asserts that spring-run review of genetic data at that time did Petitioner describes specific ecological Chinook salmon populations in the not identify clear sub-groups associated and evolutionary benefits of the life SONCC ESU have suffered significant with migration timing within the history variation provided by spring-run declines in numbers from historical SONCC Chinook salmon ESU. Spring- stocks within the SONCC Chinook abundance. The Petitioner cited and fall-run Chinook salmon were salmon ESU. The Petitioner describes findings by Nicholas and Hankin (1989) found to be separate ESUs in other areas how spring-run Chinook salmon tend to that all spring-run Chinook salmon (e.g., in the upper Columbia River, spawn higher up in the watershed than populations on the Oregon coast are Snake River, and Sacramento River fall-run and how this adds to the spatial smaller than fall-run populations and drainages). However, in coastal areas distribution of the species. The are depressed from historical population life-history and genetic differences Petitioner notes that the presence of sizes. The Petitioner presents data from between runs were found to be spring-run Chinook salmon in the the Oregon Department of Fish and relatively modest, with spring- and fall- headwaters could protect SONCC Wildlife (ODFW) that indicate a 25-year run fish exhibiting similar ocean Chinook salmon from large mortality decline in abundance of spring-run distribution patterns and genetic events due to disease outbreaks, Chinook salmon on the Rogue River characteristics (Myers et al., 1998; interspecific competition for food and (1981–2006) (ODFW 2019). During a 10- NMFS, 1999). habitat, warm temperatures and low year period (1970–1979) that spans the

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construction of the William Jess Dam analyzed samples from 2004 and The Petitioner asserts that artificially (1977) on the Rogue River, an average of reported that many of the spring-run augmented high flows in August and 28,052 adult spring-run Chinook salmon Chinook salmon counted at Gold Ray September in the Rogue River may were counted annually. ODFW (2019) dam were in fact heterozygotes. reduce egg to fry survival of spring-run estimated that there were 10,240 adult The Petitioner also calls attention to Chinook salmon. If spring-run Chinook spring-run Chinook salmon in 2017 and a declining trend in abundance of adult salmon spawn during high river flows that the annual average for the years spring-run Chinook salmon in the Smith in September, redds may be dewatered 2008–2017 was 9,663. River. The Petitioner cites data from and embryos desiccated when releases The Petitioner notes that following snorkel surveys of spring-run Chinook from the Lost Creek Reservoir decrease ODFW’s adoption of the Rogue Spring salmon in the South Fork, Middle Fork, during the reservoir fill season, which Chinook Conservation Plan in 2007, the and North Fork of the Smith River from begins in January (ODFW, 2019). ODFW average annual abundance of natural- 1982 to 2018 (Hanson, 2018). Hanson (2019) states that egg to fry survival has origin adult spring-run Chinook salmon (2018) found that the number of adult likely decreased as a result of redds increased from 7,596 to 9,663 in 2017. spring-run Chinook salmon counted per being dewatered. The Petitioner asserts that this increase mile (density) has been declining since The Petitioner also asserts that other of spring-run Chinook salmon in the survey counts peaked in 1996 at a anthropogenic disturbances have Rogue River was likely a result of the density of 2.5 salmon per mile. Hanson degraded spring-run Chinook salmon removal of the Gold Hill, Savage Rapids, (2018) reported that adult spring-run spawning habitat in the Rogue and and Gold Ray dams, which allowed Chinook salmon densities have Smith Rivers. Specifically, the heterozygous and homozygous fall-run remained at less than 0.3 salmon per Petitioner asserts that increased fine Chinook salmon to ascend upriver mile since 2007 (Hanson, 2018). The sediments due to logging, road building, rapidly and spawn with homozygous Petitioner asserts that this decline in and mining have adversely affected spring-run Chinook. In the Final Rogue spring-run Chinook salmon indicates spawning habitat which is supported by Spring Chinook Salmon Conservation that the population within the Smith similar conclusions in NMFS’ 1997 final Plan Comprehensive Assessment and River is threatened with extinction. rule listing the SONCC coho salmon Update, ODFW found that while the ESU under the ESA (62 FR 24588; May Based on information provided by the status of spring-run Chinook salmon 6, 1997), describing habitat that is co- Petitioner, as well as information improved over the past decade the ten extensive with the range of SONCC readily available in our files, we find year average is below the desired spring-run Chinook salmon. threshold of 15,000 naturally produced that a reasonable person would NMFS’ most recent SONCC coho adult spring-run Chinook salmon conclude current demographic risks salmon status review (NMFS, 2016) returning to the Rogue River annually indicate that SONCC spring-run evaluated the status of habitat threats (ODFW, 2019). The Petitioner also calls Chinook salmon populations may be at over an area that includes the range of attention to the Cole M. Rivers Hatchery risk of extinction and thus warrant SONCC spring-run Chinook salmon and and Genetic Management Plan that further investigation. concluded that degraded habitat reports the smolt to adult return rate of Analysis of ESA Section 4(a)(1) Factors conditions in this area continue to be of Cole M. Rivers Hatchery spring-run concern, particularly with regard to Chinook salmon in the Rogue River has The Petitioner asserts that all five ESA insufficient instream flow, unsuitable been below 1 percent since 2002 section 4(a)(1) factors contribute to the water temperatures, and insufficient (ODFW, 2016). The Petitioner asserts need to list the SONCC spring-run rearing habitat due to a lack of that the smolt to adult return rate for Chinook salmon as a threatened or floodplain and channel structure. While natural fish is also likely low. endangered ESU. Each of these factors is restoration and regulatory actions have The Petitioner further asserts that the discussed in further detail below. been made to improve freshwater and abundance of spring-run Chinook The Present or Threatened Destruction, estuary habitat conditions in the SONCC salmon in the Rogue River may actually Modification, or Curtailment of Its coho salmon ESU, habitat concerns be lower than reported. Hess et al. Habitat or Range remain throughout the range of the ESU (2016), Prince et al. (2017) and particularly in regards to water quality, Thompson et al. (2019) have studied the The Petitioner asserts that SONCC water quantity, and rearing habitat. relationship between genetic material spring-run Chinook salmon face Based on information provided by the from a portion of the genome that numerous threats to suitable habitat, Petitioner, as well as information includes the Greb1L gene (otherwise including impacts from dams, logging readily available in our files, we find referred to as the Greb1L region of the practices, road building, and mining that a reasonable person would genome) and run-timing in Chinook operations. The Army Corps of conclude that habitat destruction and salmon and steelhead. The authors Engineers completed construction of curtailment of their range may pose a characterized the Greb1L region as two William Jess Dam/Lost Creek Reservoir threat to the continued existence of alleles (different forms) and three on the upper Rogue River in 1977. The SONCC spring-run Chinook salmon. genotypes (different combinations of the Petitioner cites the Rogue Spring alleles): Individuals with two early run- Chinook Salmon Conservation Plan Overutilization for Commercial, timing alleles (early-run homozygotes), Comprehensive Assessment and Update Recreational, Scientific, or Educational individuals with two late run-timing (ODFW, 2019) in support of their Purposes alleles (late-run homozygotes), and assertion that artificially enhanced The Petitioner asserts that harvest of individuals with one allele for the early summer stream flows from Lost Creek SONCC spring-run Chinook salmon for and one for the late run-timing Reservoir are adversely affecting spring- commercial and recreational fisheries in (heterozygotes). Thompson et al. (2019) run Chinook salmon. ODFW (2019) the ocean and freshwater may be a asserted that there is a considerable found that enhanced summer stream threat. The Petitioner notes that the amount of interbreeding between flows allow fall-run Chinook salmon to fisheries off the coast of Oregon and spring-run and fall-run Chinook salmon spawn upstream in habitat that California are not managed to minimize in the Rogue River as a result of dam historically was utilized primarily by impacts on SONCC spring-run Chinook. construction. Thompson et al. (2019) spring-run Chinook salmon. The Petitioner notes that the Rogue

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Spring Chinook Salmon Conservation disease is known to be a primary factor are not sufficient to protect and recover Plan assumes the average harvest rate of that affects the abundance of spring-run SONCC spring-run Chinook salmon and naturally produced spring-run Chinook Chinook salmon (ODFW, 2007). The their habitat. The Petitioner states that salmon is 15 percent (ODFW, 2007). The Rogue Spring Chinook Salmon the Oregon Native Fish Conservation Petitioner does not specifically assert Conservation Plan also notes that Policy, The Rogue Spring Chinook that the harvest rates of SONCC spring- spring-run Chinook salmon in the Rogue Salmon Conservation Plan, and the run Chinook are too high. River are exposed annually to high Coles M. Rivers Hatchery and Genetic The Petitioner additionally water temperatures that increase the Management Plan do not provide summarizes the freshwater angling mortality rates of infected juvenile safeguards to stabilize or reverse regulations put in place in 2008 to Chinook salmon (ODFW, 2007). The increases in Chinook salmon protect spring-run Chinook salmon from Petitioner notes that ODFW, the Oregon heterozygous for run timing. The direct harvest in the Rogue River. The Water Resources Department, and the Petitioner asserts that insufficient Petitioner does not provide an U.S. Army Corps of Engineers now measures have been taken to prevent the explanation for why freshwater angling release water from the Lost Creek interbreeding between naturally regulations may be inadequate. ODFW Reservoir to minimize pre-spawning produced spring-run Chinook salmon (2019) states that from January through mortality of adult Chinook salmon due and hatchery produced spring-run May, anglers may only keep adipose fin- to disease (ODFW, 2019). The Rogue Chinook salmon from the Cole M. Rivers clipped hatchery spring-run Chinook Spring Chinook Salmon Conservation Hatchery. The Petitioner further asserts Salmon on the Rogue River. Wild Plan Comprehensive Assessment and that the Rogue Fall Chinook harvest opens at various sections of the Update (ODFW, 2019) states that during Conservation Plan (ODFW, 2007) does Rogue River after the early-run fish have the 2013–2015 drought, careful reservoir not adequately address the risks of passed. ODFW also states that the management resulted in no significant interbreeding with spring-run fish as a fishery does not open to wild harvest loss of fish due to disease on the Rogue. result of artificially augmented summer upstream of Dodge Bridge, where early- The Petitioner also asserts that flows (ODFW, 2013). run fish occupy deep pools during the hatchery produced coho salmon and The Petitioner notes that spring-run spring and summer. ODFW (2019) steelhead prey upon natural origin Chinook salmon on the Rogue River are found that following implementation of spring-run Chinook salmon fry. Surveys not listed as threatened or endangered the freshwater angling regulations, there conducted during 1979–81 indicated under the Oregon state Endangered were immediate reductions in that both of these species prey upon the Species Act. The Petitioner asserts that freshwater harvest and increased fry of spring-run Chinook salmon while the Rogue Spring Chinook spawner escapement (2008–2011). As a (ODFW, 2007). The Petitioner cites Species Management Unit/SONCC ESU result, adult returns of naturally estimations made by Evenson et al. is on the Oregon Sensitive Species List, produced spring-run Chinook salmon (1981) that hatchery origin steelhead the designation does not provide began to improve in 2012. The consume between 134,000 to 218,000 regulatory protection for SONCC Petitioner notes that while the estimated spring-run Chinook salmon fry and that Chinook salmon. harvest rates of natural spring-run hatchery origin coho salmon are Consistent with the petition received Chinook salmon are low, spring-run estimated to consume between 29,000 to to list an ESU of Oregon Coast spring- Chinook salmon are not meeting the 57,000 spring-run Chinook salmon fry. run Chinook salmon under the ESA, the escapement goal and homozygous In the Rogue Spring Chinook Salmon Petitioner here asserts that the Oregon spring-run Chinook salmon are likely Conservation Plan, ODFW reported that Forest Practices Act and Forest Practice declining. if these estimates are accurate, hatchery Rules do not provide adequate habitat Based on information provided by the origin salmonids consume 3–7 percent protections for spring-run Chinook Petitioner, as well as information of the natural origin spring-run Chinook salmon. For reasons previously readily available in our files, we find salmon fry produced annually in the described in the 90-day finding for that that there is inadequate information for Rogue River (ODFW, 2007). ODFW petition (85 FR 20476; April 13, 2020) a reasonable person to determine if (2007) noted that the rate of predation the petitioner asserts that it is unlikely overutilization poses a threat to the by juvenile steelhead and coho salmon that the Oregon Forest Practices Act continued existence of SONCC spring- from Cole M. Rivers Hatchery is highly adequately protects the habitat of run Chinook salmon. dependent on the duration of time that spring-run Chinook salmon in the Rogue River. Disease or Predation hatchery fish reside in the river, and on the proportion of the release groups that NMFS’ most recent SONCC coho The Petitioner asserts that disease fail to migrate downstream. ODFW salmon status review (NMFS 2016) poses a risk to naturally produced (2007) also found that predation is evaluated the inadequacy of existing spring-run Chinook in the Rogue River. likely not a primary factor contributing regulatory mechanisms over an area in ODFW (2019) found that under certain to the decline of spring-run Chinook large part co-extensive with the range of conditions disease, primarily caused by salmon in the Rogue River. SONCC spring-run Chinook salmon and the bacterium Flexibacter columnaris, Based on information provided by the concluded that the Oregon Forest can spread quickly in Rogue River Petitioner, as well as information Practices Act does not provide adequate Chinook salmon. Downstream of Gold readily available in our files, we find protection for SONCC coho salmon. Ray Dam, extensive mortalities of adults that there is inadequate information for NMFS (2016) noted that particular areas were documented in 1977, 1987, 1992, a reasonable person to determine if of concern include: (1) Whether the and 1994 due to disease (ODFW, 2007). disease or predation pose a threat to the widths of riparian management areas Estimates of mortality rates during those continued existence of SONCC spring- (RMAs) are sufficient to fully protect years ranged between 28 percent and 70 run Chinook salmon. riparian functions and stream habitats; percent of the spring-run Chinook (2) whether operations allowed within salmon that entered the Rogue River Inadequacy of Existing Regulatory RMAs will degrade stream habitats; (3) (ODFW, 2007). The Petitioner cites the Mechanisms operations on high-risk landslide sites; Rogue Spring Chinook Salmon The Petitioner asserts that existing and (4) watershed-scale effects. NMFS Conservation Plan that states that federal and state regulatory mechanisms (2016) similarly expressed concerns

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with the adequacy of California’s forest Climate Change and Ocean Conditions warranted as required by section practice rules to provide protection for 4(b)(3)(B) of the ESA. SONCC coho salmon. Specifically, The Petitioner also asserts that Information Solicited NMFS recommended the addition of the ongoing threats of poor ocean following standards to California’s forest conditions and climate change are likely to threaten the continued existence of To ensure that our status review is practice rules: (1) Provide Class II–S informed by the best available scientific (standard) streams with the same SONCC spring-run Chinook salmon. As described in NMFS’ Oregon Coast and commercial data, we are opening a protections afforded Class II–L (large) Chinook salmon status reviews (NMFS, 60-day public comment period to solicit streams, (2) include provisions to ensure 2011; Stout et al., 2012), variability in information on spring-run Chinook hydrologic disconnection between ocean conditions in the Pacific salmon in the SONCC Chinook salmon logging roads and streams, and (3) Northwest is a concern for the ESU. We request information from the include provisions to avoid hauling logs persistence of coastal Oregon Chinook public, concerned governmental on hydrologically connected streams salmon. The Petitioner also cites NMFS agencies, Native American tribes, the during winter periods. Furthermore, (2011) and Stout et al. (2012) in support scientific community, agricultural and NMFS concluded that the effects of past of assertions that predicted effects of forestry groups, conservation groups, and present timber harvest activities in climate change are expected to fishing groups, industry, or any other California continue to be an ongoing negatively affect coastal Oregon interested parties concerning the current threat to the SONCC coho salmon ESU. salmonids through many different and/or historical status of spring-run Based on information provided by the factors. The Petitioner cites the Oregon Chinook salmon in the SONCC Chinook Petitioner, as well as information Coastal Management Plan (ODFW, 2014) salmon ESU. Specifically, we request readily available in our files, we find in support of his assertion that regional information regarding: (1) Species that a reasonable person would changes in climate and weather patterns abundance; (2) species productivity; (3) conclude that the inadequacy of existing will negatively impact SONCC coastal species distribution or population regulatory mechanisms may pose a aquatic ecosystems and salmonids. The spatial structure; (4) patterns of threat to the continued existence of Petitioner cites Reiman and Isaaks phenotypic, genotypic, and life history (2010) to support his assertion that SONCC spring-run Chinook salmon. diversity; (5) habitat conditions and variable weather and warming events associated limiting factors and threats; Other Natural or Manmade Factors will become more frequent in the Pacific Affecting Its Continued Existence Northwest and continue to threaten (6) ongoing or planned efforts to protect SONCC Chinook salmon. and restore the species and their Hatcheries habitats; (7) information on the Based on information provided by the The Petitioner asserts that the Cole M. adequacy of existing regulatory Petitioner, as well as information mechanisms, whether protections are Rivers Hatchery threatens the future readily available in our files, we find being implemented, and whether they viability of spring-run Chinook salmon that a reasonable person would are proving effective in conserving the in the Rogue River. The Petitioner conclude that hatcheries and climate species; (8) data concerning the status asserts that operation of the Cole M. change may pose threats to the Rivers Hatchery poses a risk to natural continued existence of SONCC spring- and trends of identified limiting factors origin spring-run Chinook salmon due run Chinook salmon. or threats; (9) information on targeted to multiple factors including harvest (commercial and recreational) competition, predation, disease, and Petition Finding and bycatch of the species; (10) other interbreeding. The Petitioner asserts that After reviewing the information new information, data, or corrections the release of an average of 1.6 million contained in the petition, as well as including, but not limited to, taxonomic spring-run Chinook salmon annually information readily available in our or nomenclatural changes; and (11) from the Cole M. Rivers Hatchery results files, we conclude the petition presents information concerning the impacts of in increased competition between substantial scientific information environmental variability and climate naturally produced spring-run Chinook indicating that the petitioned action to change on survival, recruitment, salmon and the more abundant delineate the SONCC spring-run distribution, and/or extinction risk. artificially produced salmonids. As Chinook salmon ESU and list it as We request that all information be previously mentioned the Petitioner threatened or endangered under the accompanied by: (1) Supporting asserts that hatchery produced coho ESA may be warranted. Therefore, in documentation such as maps, salmon and steelhead prey upon natural accordance with section 4(b)(3)(A) of bibliographic references, or reprints of origin spring-run Chinook salmon fry. the ESA and NMFS’ implementing pertinent publications; and (2) the The Petitioner further notes that the regulations (50 CFR 424.14(h)(2)), we submitter’s name, address, and any hatchery is a known source of disease in will commence a status review to association, institution, or business that Chinook salmon. Amandi et al. (1982) determine whether the spring-run the person represents. found that spring-run Chinook salmon populations of SONCC Chinook salmon in the Cole M. Rivers Hatchery were constitute an ESU, and, if so, whether References found to be infected with F. columnaris that SONCC spring-run Chinook salmon and that pathogen concentrations in the ESU is in danger of extinction A complete list of all references cited outflow from the hatchery were greater throughout all or a significant portion of herein is available upon request (See than concentrations from the other its range, or likely to become so within FOR FURTHER INFORMATION CONTACT). water bodies sampled. ODFW (2019) the foreseeable future throughout all or Authority: The authority for this action is reported that it is unknown if the a significant portion of its range. After the Endangered Species Act of 1973, as infected salmon were infected with F. the conclusion of the status review, we amended (16 U.S.C. 1531 et seq.). columnaris before entering the hatchery will make a finding as to whether listing or if the salmon contracted F. the SONCC spring-run Chinook salmon columnaris after entering the hatchery. ESU as endangered or threatened is

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Dated: March 10, 2021. under section 121(a) of the what types of AT are available, use of Samuel D. Rauch III, Rehabilitation Act of 1973, as amended AT, and access to AT. Deputy Assistant Administrator for (Act). Under section 121(c)(2) of the Act, (e) Implementing professional Regulatory Programs, National Marine the Commissioner of the Rehabilitation development practices to ensure Fisheries Service. Services Administration (RSA) makes effective project coordination, [FR Doc. 2021–05338 Filed 3–15–21; 8:45 am] grants to, or enters into contracts or administration, and management. BILLING CODE 3510–22–P other cooperative agreements with, (f) Implementing appropriate financial entities that have experience in the and grant management practices to operation of AIVRS programs to provide ensure compliance with OMB’s Uniform DEPARTMENT OF EDUCATION such training and TA on developing, Guidance (2 CFR part 200) and the conducting, administering, and Education Department General Applications for New Awards; evaluating these programs. Administrative Regulations. American Indian Vocational Priority: This priority is from the (g) Evaluating project performance, Rehabilitation Training and Technical notice of final priority and definitions including data collection, data analysis, Assistance Center (NFP) for this program published and reporting. elsewhere in this issue of the Federal Specific subjects for training and TA AGENCY: Office of Special Education and Register. in each of these topic areas will be Rehabilitative Services, Department of Absolute Priority: For FY 2021, this identified on an annual basis and in Education. priority is an absolute priority. Under 34 coordination with RSA. ACTION: Notice. CFR 75.105(c)(3), we consider only Project Activities applications that meet this priority. SUMMARY: The Department of Education To be considered for funding under (Department) is issuing a notice inviting This priority is: this priority, applicants must conduct applications for fiscal year (FY) 2021 for American Indian Vocational the following activities, or a subset of American Indian Vocational Rehabilitation Services—Training and the following activities as determined Rehabilitation Training and Technical Technical Assistance Program by the Department, in a culturally Assistance Center (AIVRTTAC)— appropriate manner: Assistance Listing Number 84.250Z—to This priority funds a five-year (a) Maintain and build upon the 12 provide training and technical cooperative agreement to establish an training modules and the fiscal tool kit assistance (TA) to governing bodies of American Indian Vocational developed by the Tribal Vocational Indian Tribes that have received an Rehabilitation Training and Technical Rehabilitation Institute (the Institute) American Indian Vocational Assistance Center (AIVRTTAC) to during Federal fiscal years (FFYs) 2015– Rehabilitation Services (AIVRS) grant. provide four types of training and 2021, including maintaining the series technical assistance (TA) for the DATES: of seven training modules that build Applications available: March 16, personnel of the American Indian foundational skills that, when 2021. Vocational Rehabilitation Services satisfactorily completed, lead to a VR Deadline for transmittal of (AIVRS) projects awarded under section certificate to be awarded by the applications: June 14, 2021. 121(a) of the Rehabilitation Act of 1973, AIVRTTAC. To satisfy this activity as amended (Act), to the governing ADDRESSES: For the addresses for requirement, the grantee— obtaining and submitting an bodies of Indian Tribes and consortia of (i) Must develop both academic and application, please refer to our Common those governing bodies. The four types non-academic options for completing Instructions for Applicants to of training and TA are: (1) Intensive courses leading to the VR certificate, the Department of Education Discretionary training and TA; (2) targeted training requirements for obtaining a certificate Grant Programs, published in the and TA; (3) universal training and TA; including the specific requirements for Federal Register on February 13, 2019 and (4) capacity-building for AIVRS academic credit for courses included in (84 FR 3768) and available at project personnel through training the certificate when applicable, and www.govinfo.gov/content/pkg/FR-2019- modules that build foundational skills how the certificate may be used by the 02-13/pdf/2019-02206.pdf. for the delivery of vocational participants who earn it; rehabilitation (VR) services to AIVRS FOR FURTHER INFORMATION CONTACT: Jerry (ii) May offer the series of training project participants. The AIVRTTAC modules in a traditional classroom Elliott, U.S. Department of Education, will develop and provide these types of 400 Maryland Avenue SW, Room 5097, setting, through distance learning, training and TA for AIVRS projects in through week-long institutes, at regional Potomac Center Plaza, Washington, DC the following topic areas: 20202–2800. Telephone: (202) 245– trainings throughout the country as an (a) Applicable laws and regulations extension of national conferences, and 7335. Email: [email protected]. governing the AIVRS program. If you use a telecommunications through other delivery methods, as (b) Promising practices for providing device for the deaf (TDD) or a text appropriate, to meet the needs of the VR services to American Indians with telephone (TTY), call the Federal Relay targeted audience; disabilities. Service (FRS), toll free, at 1–800–877– (iii) May use grant funds to provide 8339. (c) The delivery of VR services to reasonable financial assistance for the American Indians with disabilities, cost of tuition, fees, and training SUPPLEMENTARY INFORMATION: including the determination of materials and to offset costs associated Full Text of Announcement eligibility, case management, case with travel for participants who may be record documentation, assessment, in remote areas of the country; I. Funding Opportunity Description development of the individualized plan (iv) Must conduct an assessment Purpose of Program: The purpose of for employment, and placement into before and after providing training for this program is to provide training and competitive integrated employment. each participant in order to assess TA to governing bodies of Indian Tribes, (d) Knowledge of assistive technology strengths and specific areas for and consortia of those governing bodies, (AT), including the definition of AT, improvement, educational attainment that have received an AIVRS grant how to evaluate the need for AT and and application of skills, and any issues

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or challenges to be addressed post- and TA it provides to determine the and TA, including the impact of the training to ensure improved delivery of effectiveness of the training and TA; AIVRTTAC’s activities on the ability of VR services to American Indians with (d) Maintain and build upon the AIVRS projects to effectively manage disabilities; topics and tools the current AIVRTTAC their projects and improve the delivery (v) Must provide follow-up TA to has developed to provide universal of VR services to American Indians with participants to address any issues or training and TA in the topic areas in disabilities. challenges that are identified post- this priority; Project Requirements training and to ensure that the training (e) Provide a minimum of two they received is applied effectively in webinars or video conferences in each To be funded under this priority, their work setting, and such follow-up of the topic areas in this priority to applicants must meet the project may be conducted as part of the describe and disseminate up-to-date requirements in this priority. RSA provision of targeted training and TA or information, guides, examples, and encourages innovative approaches to intensive training and TA as determined emerging and promising practices in meet these requirements, which are— by the needs of the specific AIVRS each area; (a) Demonstrate in the narrative project; (f) Develop new information section of the application under (vi) Must conduct an evaluation to technology (IT) platforms and systems, ‘‘Significance of the Proposed Project’’ obtain feedback on the training and or modify existing platforms and how the proposed project will— follow-up TA and to determine whether systems, as follows: (1) Use the applicant’s knowledge and this training and TA contributed to (i) Develop or modify, and maintain, experience in the operation of AIVRS increased employment outcomes for a state-of-the-art IT platform capable projects to provide training and TA for American Indians with disabilities; and reliable enough to support these projects; (vii) Are encouraged to develop a path webinars, teleconferences, video (2) Address the AIVRS projects’ by which courses offered for academic conferences, and other virtual methods capacity to effectively implement an credit lead to a degree in Rehabilitation of dissemination of information and TA; AIVRS project. To meet this or a related field; and (ii) Develop or modify, and maintain, requirement, the applicant must— (viii) May develop additional training a state-of-the-art archiving and (i) Demonstrate knowledge of modules as negotiated through the dissemination system that is open and emerging and promising practices in the cooperative agreement. available to all AIVRS projects and that topic areas in this priority; (b) Maintain and build upon the provides a central location for all AIVRS (ii) Demonstrate knowledge of current topics and tools the current AIVRRTAC training and TA products for later use, RSA guidance and Federal initiatives has developed to provide intensive including course curricula, audiovisual designed to improve the functioning of training and TA. To satisfy this activity materials, webinars, examples of grant projects in general and grant projects for American Indian Tribes in requirement, the grantee must— promising practices related to the topic particular; and (i) Develop and provide intensive areas in this priority, the primary areas (iii) Present information about the training and TA to a minimum of three identified through the annual surveys difficulties that AIVRS grantees have AIVRS projects in the first year. For completed by AIVRS projects, other encountered in implementing effective future years, the minimum number of topics identified by RSA, and other AIVRS projects; AIVRS projects to receive intensive relevant TA products (the possibility of (b) Demonstrate in the narrative training and TA will be negotiated collaborating with the National section of the application under through the cooperative agreement; Clearinghouse of Rehabilitation ‘‘Quality of Project Design’’ how the (ii) Develop and implement training Training Materials will be considered proposed project will— and TA consistent with AIVRS project with the grantee and included in the (1) Achieve its goals, objectives, and activities and tailored to the specific cooperative agreement, as appropriate); intended outcomes. To meet this needs and challenges of the AIVRS (iii) Ensure that all products produced requirement, the applicant must project receiving the intensive training by the AIVRTTAC meet government and provide— and TA; industry-recognized standards for (i) Measurable intended project (iii) Provide training and TA under an accessibility; and outcomes; agreement with each AIVRS project (iv) Ensure that all products, (ii) A plan for how the proposed receiving intensive training and TA that, resources, and materials developed by project will achieve its intended at a minimum, details the purpose of the the AIVRTTAC are widely disseminated outcomes; training and TA, intended outcomes, across the AIVRS projects and reflect (iii) A plan for communicating and and requirements for the subsequent the AIVRS population and diversity coordinating with RSA and key evaluation of the training and TA; and among its communities to the maximum personnel of AIVRS projects; and (iv) Assess the results of the training extent possible. (iv) A draft training module or outline and TA 90 days after its completion to (g) Establish a community of practice for a targeted training and TA ensure that the recipient is able to apply (or communities of practice) that will presentation or an outline for intensive effectively the training and TA, identify serve as a vehicle for communication, training and TA activities for one of the any issues or challenges in its an exchange of information among topic areas in this priority to implementation, and provide additional AIVRS projects, and a forum for sharing demonstrate how participants would be training and TA, either virtually or on- the results of training and TA projects trained in that area. The module or site, as needed. that are in progress or have been outline is a required attachment in the (c) Maintain and build upon the completed; application and must include, at a topics and tools the current AIVRTTAC (h) Conduct outreach to AIVRS minimum, the following: has developed to provide a range of projects so that they are aware of, and (A) The goals and objectives of this targeted training and TA in the topic can participate in, training and TA training module, targeted training and areas described in this priority based on activities; and TA activity, or intensive training and needs common to multiple AIVRS (i) Conduct an evaluation to TA activities; projects. The grantee must follow up determine the quality, relevance, and (B) A specific list of what participants with the recipients of targeted training usefulness of the AIVRTTAC’s training should know and be able to do as a

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result of successfully completing the (B) Its proposed methodology for achieve the project’s intended module, targeted training and TA providing intensive training and TA to outcomes, including how the proposed activity, or intensive training and TA recipients; and project personnel have a high degree of activities; (C) Its proposed approach to assessing knowledge and understanding of (C) Up-to-date resources, publications, the training and TA needs of recipients, cultural factors that will be sufficient to applicable laws and regulations, and including their ability to respond ensure the delivery of training and TA other materials that may be used to effectively to the training and TA; and in a culturally appropriate manner; develop the module, targeted training (iv) Its proposed approach to (e) Demonstrate in the narrative and TA activity, or intensive training maintaining and building upon section of the application under and TA activities; capacity-building modules, which must ‘‘Quality of the Management Plan’’ how (D) Exercises that will provide an identify— the proposed management plan will opportunity for application of the (A) Its proposed approach to ensure that the project’s intended subject matter; maintaining the 12 training modules outcomes will be achieved on time and (E) A description of how participant and the fiscal tool kit developed by the within budget. To address this knowledge, skills, and abilities will be Institute in FFYs 2015–2021, including requirement, the applicant must measured; and maintaining the series of seven training describe— (F) In the case of an intensive training modules that build foundational skills (1) Clearly defined roles and and TA intervention, how the outcomes that, when satisfactorily completed, lead responsibilities for at least two full-time and impact of the intensive training and to a VR certificate to be awarded by the key project personnel designated to the TA intervention will be measured; grantee; and AIVRTTAC through the entire project (2) Use a logic model to develop (B) Its proposed approach to period and for consultants and project plans and activities that identifying, developing, and delivering subcontractors, as applicable; includes, at a minimum, the goals, new capacity-building modules; and (2) Timelines and milestones for activities, outputs, and outcomes of the (5) Develop products and implement accomplishing the project tasks; proposed project; services to maximize the proposed (3) Using a personnel loading chart, (3) Be based on current research and project’s efficiency. To address this detailed project activities through the make use of emerging and promising requirement, the applicant must entire project period, key personnel and practices, and evidence-based practices, describe— any consultants or subcontractors that (i) How the proposed project will use where available. To meet this will be allocated to each activity, and technology to achieve the intended requirement the applicant must the designated level of effort for each of project outcomes; describe— those activities; (ii) With whom the proposed project (4) How the personnel allocations in (i) The current research on the will collaborate and the intended the personnel loading chart are emerging and promising practices in the outcomes of this collaboration; and appropriate and adequate to achieve the topic areas in this priority; and (iii) In particular, how the proposed project’s intended outcomes, including (ii) How the AIVRTTAC will project will coordinate and collaborate an assurance that all personnel will incorporate current research and with other RSA-funded technical communicate with stakeholders and promising and evidence-based practices, assistance centers to exchange and RSA in a timely way; including research about adult learning adapt relevant products and materials to (5) How the proposed management principles and implementation science, avoid duplication and make effective plan will ensure that the training and in the development and delivery of its use of grant funds to better manage the TA products developed through this products and services; AIVRTTAC project and its available cooperative agreement are complete, (4) Develop products and provide resources to improve service delivery to accurate, and of high quality; and services that are of high quality and of AIVRS projects; (6) How the proposed project will sufficient intensity and duration to (c) Demonstrate in the narrative benefit from a diversity of perspectives, achieve the intended outcomes of the section of the application under including AIVRS projects and proposed project. To address this ‘‘Adequacy of Project Resources’’ how— consumers, State VR agencies, TA requirement the applicant must (1) The applicant and any key providers, and policy makers, in its describe— partners possess adequate resources to development and operation; and (i) Its proposed approach to universal carry out the proposed activities; and (f) Demonstrate in the narrative training and TA; (2) The proposed costs are reasonable section of the application under (ii) Its proposed approach to targeted in relation to the anticipated results and ‘‘Quality of the Evaluation Plan’’ how training and TA, which must identify— benefits; the applicant proposes to collect and (A) The intended recipients of the (d) Demonstrate in the narrative analyze data on specific and measurable products and services under this section of the application under goals, objectives, and intended approach, including the categories of ‘‘Quality of Project Personnel’’ how— outcomes of the project, including the personnel that would be receiving the (1) The proposed project will effectiveness of the training and TA training and TA; encourage applications for employment provided. To address this requirement, (B) Its proposed methods for from persons who are members of the applicant must describe— providing targeted training and TA; and groups that have historically been (i) Its proposed evaluation (C) Its proposed methodology for underrepresented based on race, color, methodologies, including instruments, determining topics for the targeted national origin, gender, age, or data collection methods, and analyses; training and TA; disability, as appropriate; and (ii) Its proposed standards or targets (iii) Its proposed approach to (2) The proposed key project for determining effectiveness; intensive training and TA, which must personnel, consultants, and (iii) How it will use the evaluation identify— subcontractors have the qualifications results to examine the effectiveness of (A) Its proposed approach to and experience to provide training and its implementation and its progress identifying recipients for intensive TA to AIVRS projects in each of the toward achieving the intended training and TA; topic areas in this priority and to outcomes; and

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(iv) How the methods of evaluation regulations of the Department in 2 CFR document if it clearly establishes the will produce quantitative and part 3485. (c) The Uniform nonprofit status of the applicant; or (4) qualitative data that demonstrate Administrative Requirements, Cost any item described above if that item whether the project and individual Principles, and Audit Requirements for applies to a State or national parent training and TA activities achieved their Federal Awards in 2 CFR part 200, as organization, together with a statement intended outcomes. adopted and amended as regulations of by the State or parent organization that Definitions: These definitions are the Department in 2 CFR part 3474. (d) the applicant is a local nonprofit from the NFP. The NFP. affiliate. Intensive training and technical Note: The regulations in 34 CFR part 2. a. Cost Sharing or Matching: This assistance means training and TA 86 apply to institutions of higher competition does not require cost provided to the governing bodies of education only. sharing or matching. Indian Tribes that have received an II. Award Information b. Indirect Cost Rate Information: This AIVRS grant and to the current program uses an unrestricted indirect personnel of the AIVRS projects Type of Award: Discretionary grant. cost rate. Applicants for this program primarily on-site over an extended Estimated Available Funds: are State, local, or Tribal governments, period. Intensive training and TA is $1,013,000. nonprofit organizations, or institutions based on an ongoing relationship Estimated Average Size of Awards: of higher education that have between the training and TA center staff $1,013,000. experience in the operation of AIVRS Estimated Number of Awards: 1. and the governing bodies of Indian programs and have negotiated indirect Tribes that have received an AIVRS Note: The Department is not bound by any estimates in this notice. cost rate agreements with a cognizant grant and the current personnel of the agency if indirect costs will be charged AIVRS projects under the terms of a Project Period: Up to 60 months. Continuing the Fourth and Fifth Years to the grant. For more information signed intensive training and TA regarding indirect costs, or to obtain a agreement. of the Program: In deciding whether to negotiated indirect cost rate, please see Targeted training and technical continue funding fourth and fifth years, www2.ed.gov/about/offices/list/ocft/ assistance means training and TA based the Department will consider, as part of on needs common, to one or more the review, the cooperative agreement, intro.html. governing bodies of Indian Tribes that the application narrative, and the c. Administrative Cost Limitation: have received an AIVRS grant and to the annual performance reports; the degree This program does not include any current personnel of the AIVRS projects to which AIVRTTAC demonstrates program-specific limitation on on a time-limited basis and with limited substantial progress in providing administrative expenses. All commitment of training and TA center intensive training and TA to AIVRS administrative expenses must be resources. Targeted training and TA are projects, targeted training and TA to reasonable and necessary and conform delivered through virtual or in-person AIVRS projects, universal training and to Cost Principles described in 2 CFR methods tailored to the identified needs TA to AIVRS projects, and capacity- part 200 subpart E of the Uniform of the participating governing bodies of building for AIVRS project personnel Guidance. Indian Tribes that have received an through training modules that build 3. Subgrantees: A grantee under this AIVRS grant and to the current foundational skills for the delivery of competition may not award subgrants to personnel of the AIVRS projects. VR services to AIVRS project entities to directly carry out project Universal training and technical participants; and the extent to which the activities described in its application. assistance means training and TA training and TA provided has had an IV. Application and Submission broadly available to governing bodies of impact on the ability of AIVRS projects Information Indian Tribes that have received an to implement appropriate practices in AIVRS grant and to the current the seven topic areas outlined in the 1. Application Submission personnel of the AIVRS projects and priority. Instructions: Applicants are required to other interested parties through their follow the Common Instructions for III. Eligibility Information own initiative, resulting in minimal Applicants to Department of Education interaction with training and TA center 1. Eligible Applicants: State, local, or Discretionary Grant Programs, staff. Universal training and TA Tribal governments, nonprofit published in the Federal Register on includes generalized presentations, organizations, or institutions of higher February 13, 2019 (84 FR 3768), and products, and related activities available education that have experience in the available at www.govinfo.gov/content/ through a website or through brief operation of AIVRS programs. pkg/FR-2019-02-13/pdf/2019-02206.pdf, contacts with the training and TA center Note: If you are a nonprofit which contain requirements and staff. organization, under 34 CFR 75.51, you information on how to submit an Program Authority: 29 U.S.C. 741. may demonstrate your nonprofit status application. Note: Projects will be awarded and by providing: (1) Proof that the Internal 2. Intergovernmental Review: This must be operated in a manner consistent Revenue Service currently recognizes competition is not subject to Executive with the nondiscrimination the applicant as an organization to Order 12372 and the regulations in 34 requirements contained in Federal civil which contributions are tax deductible CFR part 79. rights laws. under section 501(c)(3) of the Internal 3. Funding Restrictions: We reference Applicable Regulations: (a) The Revenue Code; (2) a statement from a regulations outlining funding Education Department General State taxing body or the State attorney restrictions in the Applicable Administrative Regulations in 34 CFR general certifying that the organization Regulations section of this notice. parts 75, 77, 81, 82, 84, and 86. (b) The is a nonprofit organization operating V. Application Review Information Office of Management and Budget within the State and that no part of its Guidelines to Agencies on net earnings may lawfully benefit any 1. Selection Criteria: The selection Governmentwide Debarment and private shareholder or individual; (3) a criteria for this competition are from 34 Suspension (Nonprocurement) in 2 CFR certified copy of the applicant’s CFR 75.210, have a maximum score of part 180, as adopted and amended as certificate of incorporation or similar 100 points, and are as follows:

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(a) Need for Project and Significance are appropriate to the needs of the adequate to meet the objectives of the (10 Points): intended recipients or beneficiaries of proposed project. The Secretary considers the need for those services. (g) Quality of the Project Evaluation and significance of the proposed project. (2) The likely impact of the services (10 Points): In determining the need for and to be provided by the proposed project The Secretary considers the quality of significance of the proposed project, the on the intended recipients of those the evaluation to be conducted of the Secretary considers the following services. proposed project. In determining the factors: (3) The extent to which the services quality of the evaluation, the Secretary (1) The magnitude of the need for the to be provided by the proposed project considers the following factors: services to be provided or the activities involve the collaboration of appropriate (1) The extent to which the methods to be carried out by the proposed partners for maximizing the of evaluation are thorough, feasible, and project. effectiveness of project services. appropriate to the goals, objectives, and (2) The extent to which specific gaps (d) Quality of Project Personnel (15 outcomes of the proposed project. or weaknesses in services, Points): (2) The extent to which the methods infrastructure, or opportunities have In determining the quality of project of evaluation include the use of been identified and will be addressed by personnel, the Secretary considers the objective performance measures that are the proposed project, including the extent to which the applicant clearly related to the intended outcomes nature and magnitude of those gaps or encourages applications for employment of the project and will produce weaknesses. from persons who are members of quantitative and qualitative data to the (3) The potential contribution of the groups that have traditionally been extent possible. proposed project to increased underrepresented based on race, color, (3) The extent to which the methods knowledge or understanding of national origin, gender, age, or of evaluation will provide performance rehabilitation problems, issues, or disability. feedback and permit periodic effective strategies. In addition, the Secretary considers assessment of progress toward achieving (4) The extent to which the proposed the qualifications, including relevant intended outcomes. project is likely to build local capacity training and experience, of key project 2. Review and Selection Process: We to provide, improve, or expand services personnel. remind potential applicants that in that address the needs of the target (e) Adequacy of Resources (10 Points): reviewing applications in any population. The Secretary considers the adequacy discretionary grant competition, the (b) Quality of the Project Design (20 of resources for the proposed project. In Secretary may consider, under 34 CFR Points): determining the adequacy of resources 75.217(d)(3), the past performance of the The Secretary considers the quality of for the proposed project, the Secretary applicant in carrying out a previous the design of the proposed project. In considers the following factors: award, such as the applicant’s use of determining the quality of the design of (1) The adequacy of support, funds, achievement of project the proposed project, the Secretary including facilities, equipment, objectives, and compliance with grant considers the following factors: supplies, and other resources, from the conditions. The Secretary may also (1) The extent to which the goals, applicant organization or the lead consider whether the applicant failed to objectives, and outcomes to be achieved applicant organization. submit a timely performance report or by the proposed project are clearly (2) The extent to which the costs are submitted a report of unacceptable specified and measurable. reasonable in relation to the objectives, quality. (2) The extent to which the design of design, and potential significance of the In addition, in making a competitive the proposed project is appropriate to, proposed project. grant award, the Secretary requires and will successfully address, the needs (3) The extent to which the costs are various assurances, including those of the target population or other reasonable in relation to the number of applicable to Federal civil rights laws identified needs. persons to be served and to the that prohibit discrimination in programs (3) The extent to which the proposed anticipated results and benefits. or activities receiving Federal financial project will establish linkages with (f) Quality of the Management Plan assistance from the Department (34 CFR other appropriate agencies and (15 Points): 100.4, 104.5, 106.4, 108.8, and 110.23). organizations providing services to the The Secretary considers the quality of 3. Risk Assessment and Specific target population. the management plan for the proposed Conditions: Consistent with 2 CFR (c) Quality of Project Services (20 project. In determining the quality of the 200.206, before awarding grants under Points): management plan for the proposed this competition the Department The Secretary considers the quality of project, the Secretary considers the conducts a review of the risks posed by the services to be provided by the following factors: applicants. Under 2 CFR 200.208, the proposed project. In determining the (1) The adequacy of the management Secretary may impose specific quality of the services to be provided by plan to achieve the objectives of the conditions and, under 2 CFR 3474.10, in the proposed project, the Secretary proposed project on time and within appropriate circumstances, high-risk considers the quality and sufficiency of budget, including clearly defined conditions on a grant if the applicant or strategies for ensuring equal access and responsibilities, timelines, and grantee is not financially stable; has a treatment for eligible project milestones for accomplishing project history of unsatisfactory performance; participants who are members of groups tasks. has a financial or other management that have traditionally been (2) The adequacy of procedures for system that does not meet the standards underrepresented based on race, color, ensuring feedback and continuous in 2 CFR part 200, subpart D; has not national origin, gender, age, or improvement in the operation of the fulfilled the conditions of a prior grant; disability. proposed project. or is otherwise not responsible. In addition, the Secretary considers (3) The extent to which the time 4. Integrity and Performance System: the following factors: commitments of the project director and If you are selected under this (1) The extent to which the services principal investigator and other key competition to receive an award that to be provided by the proposed project project personnel are appropriate and over the course of the project period

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may exceed the simplified acquisition containing a link to access an electronic preparation class offered by the threshold (currently $250,000), under 2 version of your GAN. We may notify AIVRTTAC. CFR 200.206(a)(2) we must make a you informally, also. (c) Of all AIVRS project staff, the judgment about your integrity, business If your application is not evaluated or number and percentage of AIVRS ethics, and record of performance under not selected for funding, we notify you. project staff that receive a certificate Federal awards—that is, the risk posed 2. Administrative and National Policy based on classes offered by the by you as an applicant—before we make Requirements: We identify AIVRTTAC. an award. In doing so, we must consider administrative and national policy (d) Of AIVRS projects that received any information about you that is in the requirements in the application package intensive training and technical integrity and performance system and reference these and other assistance, the number and percentage (currently referred to as the Federal requirements in the Applicable of AIVRS projects that completed all Awardee Performance and Integrity Regulations section of this notice. activities in the intensive TA agreement. Information System (FAPIIS)), We reference the regulations outlining (e) Of AIVRS projects that received accessible through the System for the terms and conditions of an award in intensive training and technical Award Management. You may review the Applicable Regulations section of assistance, the number and percentage and comment on any information about this notice and include these and other of AIVRS projects that show an increase yourself that a Federal agency specific conditions in the GAN. The in consumers achieving an employment previously entered and that is currently GAN also incorporates your approved outcome compared to the prior year. in FAPIIS. application as part of your binding (f) Of AIVRS projects that received Please note that, if the total value of commitments under the grant. intensive training and technical your currently active grants, cooperative 3. Reporting: (a) If you apply for a assistance, the number and percentage agreements, and procurement contracts grant under this competition, you must of AIVRS projects that show an increase from the Federal Government exceeds ensure that you have in place the in consumers receiving services under $10,000,000, the reporting requirements necessary processes and systems to an IPE compared to the prior year. in 2 CFR part 200, Appendix XII, comply with the reporting requirements Applicable short-term and long-term require you to report certain integrity in 2 CFR part 170 should you receive indicators and targets will be specified information to FAPIIS semiannually. funding under the competition. This in the AIVRTTAC cooperative Please review the requirements in 2 CFR does not apply if you have an exception agreement. part 200, Appendix XII, if this grant under 2 CFR 170.110(b). Annual project progress toward plus all the other Federal funds you (b) At the end of your project period, meeting project goals must be posted on receive exceed $10,000,000. you must submit a final performance the project website. 5. In General: In accordance with the report, including financial information, 5. Continuation Awards: In making a Office of Management and Budget’s as directed by the Secretary. If you continuation award under 34 CFR guidance located at 2 CFR part 200, all receive a multiyear award, you must 75.253, the Secretary considers, among applicable Federal laws, and relevant submit an annual performance report other things: whether a grantee has Executive guidance, the Department that provides the most current made substantial progress in achieving will review and consider applications performance and financial expenditure the goals and objectives of the project; for funding pursuant to this notice information as directed by the Secretary whether the grantee has expended funds inviting applications in accordance under 34 CFR 75.118. The Secretary in a manner that is consistent with its with— may also require more frequent (a) Selecting recipients most likely to approved application and budget; and, performance reports under 34 CFR be successful in delivering results based if the Secretary has established 75.720(c). For specific requirements on on the program objectives through an performance measurement reporting, please go to www.ed.gov/ objective process of evaluating Federal requirements, the performance targets in fund/grant/apply/appforms/ award applications (2 CFR 200.205); the grantee’s approved application. (b) Prohibiting the purchase of certain appforms.html. In making a continuation award, the telecommunication and video 4. Performance Measures: The Secretary also considers whether the surveillance services or equipment in Government Performance and Results grantee is operating in compliance with alignment with section 889 of the Act of 1993 (GPRA) directs Federal the assurances in its approved National Defense Authorization Act of departments and agencies to improve application, including those applicable 2019 (Pub. L. 115—232) (2 CFR the effectiveness of their programs by to Federal civil rights laws that prohibit 200.216); engaging in strategic planning, setting discrimination in programs or activities (c) Providing a preference, to the outcome-related goals for programs, and receiving Federal financial assistance extent permitted by law, to maximize measuring program results against those from the Department (34 CFR 100.4, use of goods, products, and materials goals. 104.5, 106.4, 108.8, and 110.23). For the purposes of GPRA and produced in the United States (2 CFR VII. Other Information 200.322); and Department reporting under 34 CFR (d) Terminating agreements in whole 75.110, we have established the Accessible Format: On request to the or in part to the greatest extent following performance measures for this program contact person listed under FOR authorized by law if an award no longer program: FURTHER INFORMATION CONTACT, effectuates the program goals or agency (a) Of all AIVRS project staff, the individuals with disabilities can obtain priorities (2 CFR 200.340). number and percentage of AIVRS this document and a copy of the project staff that complete at least on application package in an accessible VI. Award Administration Information personnel preparation class offered by format. The Department will provide the 1. Award Notices: If your application the AIVRTTAC. requestor with an accessible format that is successful, we notify your U.S. (b) Of all AIVRS projects, the number may include Rich Text Format (RTF) or Representative and U.S. Senators and and percentage of AIVRS projects that text format (txt), a thumb drive, an MP3 send you a Grant Award Notification have at least one staff member that has file, braille, large print, audiotape, or (GAN); or we may send you an email completed at least one personnel compact disc, or other accessible format.

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Electronic Access to This Document: • The seal reflects the EAC’s testing The proposed River Lock The official version of this document is and certification of voting machines by and Dam No. 8 Hydroelectric Project the document published in the Federal showing a circuit board. would consist of the following: (1) An Register. You may access the official • The circuit board diodes existing 309-foot-long, 31-foot-high, edition of the Federal Register and the incorporate the word ‘‘VOTE’’ in Braille timber crib dam with concrete overlay Code of Federal Regulations at reflecting the importance of accessibility connected to a 384-foot-long, and 52- www.govinfo.gov. At this site you can for voters with disabilities and EAC’s foot-wide abandoned navigation lock, view this document, as well as all other role in ensuring all Americans can vote which are owned by the Kentucky River documents of this Department privately and independently. Authority; (2) a reservoir with a surface published in the Federal Register, in • The flag reflects democracy, the area of 499 acres and a storage capacity text or Portable Document Format EAC as a federal agency, and voters’ of 8,700 acre-feet; (3) six, proposed, 32- (PDF). To use PDF you must have rights. foot-long, 9-foot-diameter penstocks Adobe Acrobat Reader, which is • The three stars in the flag represent connected to six generating units with a available free at the site. the three main functions of the EAC: combined capacity of 3.7 megawatts, You may also access documents of the Clearinghouse, Testing and within the existing lock; (4) a proposed Department published in the Federal Certification, Research. powerhouse/control room adjacent to • Register by using the article search The ballot box reflects the various the lock; (5) a 30-foot-long by 75-foot- feature at: www.federalregister.gov. options of voting and the EAC’s mission wide tailrace; and (6) a 675-foot-long, Specifically, through the advanced to assist with election administration 12.47 kilo-Volt transmission line. The search feature at this site, you can limit best practices. proposed project would have an your search to documents published by Permission is required for the estimated annual generation of 21,002 the Department. replication or use of this seal. The seal megawatt-hours. is effective on March 15, 2021. The EAC Applicant Contact: Jessica Penrod, David Cantrell, believes that delaying the effective date Natel Energy, Inc., 2401 Monarch Street, Deputy Director, Office of Special Education is unnecessary as this is a notice Alameda, CA 9401; phone: (415) 845– Programs. Delegated the authority to perform regarding agency organization, 1933. the functions and duties of the Assistant procedure, and practice and there are no FERC Contact: Joshua Dub; phone: Secretary for the Office of Special Education changes to public access to the agency (202) 502–8138. and Rehabilitative Services. or agency services provided to the Deadline for filing comments, motions [FR Doc. 2021–05429 Filed 3–11–21; 4:15 pm] public. Additionally, the public will to intervene, competing applications BILLING CODE 4000–01–P benefit immediately from recognition of (without notices of intent), or notices of the new official logo of the EAC on intent to file competing applications: 60 official documents and materials. days from the issuance of this notice. Competing applications and notices of ELECTION ASSISTANCE COMMISSION Amanda Joiner, intent must meet the requirements of 18 Associate Counsel, U.S. Election Assistance CFR 4.36. Notice of Agency Organization, Commission. The Commission strongly encourages Procedure, and Practice; New Agency [FR Doc. 2021–05417 Filed 3–15–21; 8:45 am] electronic filing. Please file comments, Seal BILLING CODE P motions to intervene, notices of intent, and competing applications using the AGENCY: U.S. Election Assistance Commission’s eFiling system at https:// Commission. DEPARTMENT OF ENERGY ferconline.ferc.gov/FERCOnline.aspx. ACTION: Notice. Commenters can submit brief comments Federal Energy Regulatory up to 6,000 characters, without prior SUMMARY: The EAC is implementing a Commission registration, using the eComment system new official agency seal for use on all at https://ferconline.ferc.gov/ [Project No. 15054–000] agency internal and external QuickComment.aspx. You must include correspondence, communications, Kinet, Inc.; Notice of Preliminary your name and contact information at media, materials, and methods of the end of your comments. For identification. Permit Application Accepted for Filing and Soliciting Comments, Motions To assistance, please contact FERC Online DATES: The new agency seal is effective Intervene, and Competing Applications Support at FERCOnlineSupport@ on March 15, 2021. ferc.gov, (866) 208–3676 (toll free), or On November 6, 2020, Kinet, Inc., (202) 502–8659 (TTY). In lieu of FOR FURTHER INFORMATION CONTACT: filed an application for a preliminary electronic filing, you may submit a Kristen Muthig, Telephone: (202) 897– permit, pursuant to section 4(f) of the paper copy. Submissions sent via the 9285, Email: [email protected]. Federal Power Act (FPA), proposing to U.S. Postal Service must be addressed SUPPLEMENTARY INFORMATION: In 2021, study the feasibility of a conventional to: Kimberly D. Bose, Secretary, Federal the U.S. Election Assistance hydropower project located in Energy Regulatory Commission, 888 Commission (EAC) underwent the Jessamine, Garrard, and Madison First Street NE, Room 1A, Washington, process to rebrand and develop a new Counties, Kentucky. The sole purpose of DC 20426. Submissions sent via any seal for the agency to better reflect the a preliminary permit, if issued, is to other carrier must be addressed to: mission and work of the EAC. Since the grant the permit holder priority to file Kimberly D. Bose, Secretary, Federal agency was established by the Help a license application during the permit Energy Regulatory Commission, 12225 America Vote Act of 2002 (HAVA), the term. A preliminary permit does not Wilkins Avenue, Rockville, Maryland EAC used a variation of the Great Seal authorize the permit holder to perform 20852. of the United States for its logo. any land-disturbing activities or More information about this project, As the new seal was developed, the otherwise enter upon lands or waters including a copy of the application, can following considerations were made and owned by others without the owners’ be viewed or printed on the ‘‘eLibrary’’ elements incorporated: express permission. link of the Commission’s website at

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https://elibrary.ferc.gov/eLibrary/search. FERC Contact: Joshua Dub; phone: Mountain Pumped Storage Hydro Enter the docket number (P–15054) in (202) 502–8138. Project, has requested that its the docket number field to access the Deadline for filing comments, motions preliminary permit be terminated. The document. For assistance, contact FERC to intervene, competing applications permit was issued on May 8, 2018 and Online Support. (without notices of intent), or notices of would have expired on April 30, 2021.1 Dated: March 10, 2021. intent to file competing applications: 60 The project would have been located in days from the issuance of this notice. Converse County, Wyoming. Kimberly D. Bose, Competing applications and notices of The preliminary permit for Project Secretary. intent must meet the requirements of 18 No. 14863 will remain in effect until the [FR Doc. 2021–05382 Filed 3–15–21; 8:45 am] CFR 4.36. close of business, April 9, 2021. But, if BILLING CODE 6717–01–P The Commission strongly encourages electronic filing. Please file comments, the Commission is closed on this day, motions to intervene, notices of intent, then the permit remains in effect until DEPARTMENT OF ENERGY the close of business on the next day in and competing applications using the 2 Commission’s eFiling system at https:// which the Commission is open. New Federal Energy Regulatory ferconline.ferc.gov/FERCOnline.aspx. applications for this site may not be Commission Commenters can submit brief comments submitted until after the permit surrender is effective. [Project No. 15059–000] up to 6,000 characters, without prior registration, using the eComment system Dated: March 10, 2021. Kinet, Inc.; Notice of Preliminary at https://ferconline.ferc.gov/ Kimberly D. Bose, Permit Application Accepted for Filing QuickComment.aspx. You must include Secretary. and Soliciting Comments, Motions To your name and contact information at [FR Doc. 2021–05381 Filed 3–15–21; 8:45 am] Intervene, and Competing Applications the end of your comments. For assistance, please contact FERC Online BILLING CODE 6717–01–P On December 3, 2020, Kinet, Inc., Support at FERCOnlineSupport@ filed an application for a preliminary ferc.gov, (866) 208–3676 (toll free), or DEPARTMENT OF ENERGY permit, pursuant to section 4(f) of the (202) 502–8659 (TTY). In lieu of Federal Power Act (FPA), proposing to electronic filing, you may submit a Federal Energy Regulatory study the feasibility of a conventional paper copy. Submissions sent via the Commission hydropower project located in U.S. Postal Service must be addressed Anderson, Woodford, and Mercer to: Kimberly D. Bose, Secretary, Federal Sunshine Act Meeting Counties, Kentucky. The sole purpose of Energy Regulatory Commission, 888 a preliminary permit, if issued, is to First Street NE, Room 1A, Washington, The following notice of meeting is grant the permit holder priority to file DC 20426. Submissions sent via any published pursuant to section 3(a) of the a license application during the permit other carrier must be addressed to: government in the Sunshine Act (Pub. term. A preliminary permit does not Kimberly D. Bose, Secretary, Federal L. 94–409), 5 U.S.C. 552b: authorize the permit holder to perform Energy Regulatory Commission, 12225 any land-disturbing activities or Wilkins Avenue, Rockville, Maryland AGENCY HOLDING MEETING: Federal otherwise enter upon lands or waters 20852. Energy Regulatory Commission. owned by others without the owners’ More information about this project, TIME AND DATE: March 18, 2021, 10:00 express permission. including a copy of the application, can a.m. The proposed Kentucky River Lock be viewed or printed on the ‘‘eLibrary’’ and Dam No. 5 Hydroelectric Project link of the Commission’s website at PLACE: Open to the public via audio would consist of the following: (1) An https://elibrary.ferc.gov/eLibrary/search. Webcast only. Join FERC online to listen existing 594-foot-long, 36-foot-high, Enter the docket number (P–15059) in live at http://ferc.capitolconnection.org/. timber crib dam with concrete overlay the docket number field to access the STATUS: Open. connected to a 390-foot-long, and 38- document. For assistance, contact FERC foot-wide abandoned navigation lock, Online Support. MATTERS TO BE CONSIDERED: Agenda. * Note—Items listed on the agenda may which are owned by the Kentucky River Dated: March 10, 2021. be deleted without further notice. Authority; (2) a reservoir with a surface Kimberly D. Bose, area of 448 acres and a storage capacity Secretary. CONTACT PERSON FOR MORE INFORMATION: of 7,500 acre-feet; (3) five, proposed, 32- [FR Doc. 2021–05383 Filed 3–15–21; 8:45 am] Kimberly D. Bose, Secretary, Telephone foot-long, 9-foot-diameter penstocks (202) 502–8400. connected to five generating units with BILLING CODE 6717–01–P a combined capacity of 2.4 megawatts, For a recorded message listing items struck from or added to the meeting, call within the existing lock; (4) a proposed DEPARTMENT OF ENERGY powerhouse/control room adjacent to (202) 502–8627. the lock; (5) a 30-foot-long by 63-foot- Federal Energy Regulatory This is a list of matters to be wide tailrace; and (6) a 175-foot-long, Commission considered by the Commission. It does 12.47 kilo-Volt transmission line. The not include a listing of all documents proposed project would have an [Project No. 14863–001] relevant to the items on the agenda. All estimated annual generation of 16,243 BM Energy Park, LLC; Notice of public documents, however, may be megawatt-hours. Surrender of Preliminary Permit viewed on line at the Commission’s Applicant Contact: Dan Panko, Kinet, website at http:// Inc., 2401 Monarch Street, Alameda, CA Take notice that BM Energy Park LLC, ferc.capitolconnection.org/ using the 9401; phone: (802) 578–7973. permittee for the proposed Banner eLibrary link.

1 163 FERC ¶ 62,080 (2018). 2 18 CFR 385.2007(a)(2) (2020).

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1076TH—MEETING [Open meeting; March 18, 2021; 10:00 a.m.]

Item No. Docket No. Company

ADMINISTRATIVE

A–1 ...... AD21–1–000 ...... Agency Administrative Matters. A–2 ...... AD21–2–000 ...... Customer Matters, Reliability, Security and Market Operations. A–3 ...... AD06–3–000 ...... Market Update.

ELECTRIC

E–1 ...... RM18–9–002 ...... Participation of Distributed Energy Resource Aggregations in Markets Operated by Regional Transmission Organizations and Independent System Operators. E–2 ...... RM21–14–000 ...... Participation of Aggregators of Retail Demand Response Customers in Markets Operated by Regional Transmission Organizations and Independent System Operators. E–3 ...... QF17–454–006 ...... Broadview Solar, LLC. E–4 ...... EL19–47–000 ...... Independent Market Monitor for PJM v. PJM Interconnection, L.L.C. EL19–63–000 ...... Office of the People’s Counsel for the District of Columbia, Delaware Division of the Public Advocate, Citizens Utility Board, Office of Utility Consumer Counselor, Maryland Office of People’s Counsel, Pennsylvania Office of Con- sumer Advocate, West Virginia Consumer Advocate Division, and PJM Indus- trial Customer Coalition v. PJM Interconnection, L.L.C. E–5 ...... EL21–35–000 ...... Hollow Road Solar LLC. E–6 ...... EL21–14–000 ...... NextEra Energy, Inc., Evergy, Inc., American Electric Power Company, Exelon Corporation, Xcel Energy Services Inc. E–7 ...... RM16–17–000 ...... Data Collection for Analytics and Surveillance and Market-Based Rate Purposes. E–8 ...... Omitted E–9 ...... ER21–679–000 ...... Midcontinent Independent System Operator, Inc. E–10 ...... ER20–1210–001 ...... Hazleton Generation LLC. E–11 ...... ER20–1237–000 ...... Ameren Company. E–12 ...... ER19–1276–001 ...... Ameren Illinois Company. E–13 ...... ER20–1892–000 ...... Midcontinent Independent System Operator, Inc. E–14 ...... ER17–801–010 ...... Constellation Power Source Generation, LLC. E–15 ...... ER18–2497–005 ...... Lawrenceburg Power, LLC. E–16 ...... EC21–10–000 ...... NextEra Energy Transmission, LLC, GridLiance West LLC, GridLiance High Plains LLC, and GridLiance Hearthland LLC. E–17 ...... RD21–2–000 ...... North American Electric Reliability Corporation. E–18 ...... EL21–13–000 ...... Californians for Green Nuclear Power, Inc. v.The North American Electric Reli- ability Corporation, the Western Electricity Coordinating Council, the California Independent System Operator, the California Public Utilities Commission, the California State Water Resources Control Board, and the California State Lands Commission. E–19 ...... EL20–69–000 ...... Californians for Renewable Energy and Michael E. Boyd v. California Independent System Operator Corporation, California Public Utilities Commission, Pacific Gas and Electric Company, San Diego Gas and Electric Company and South- ern California Edison Company. E–20 ...... EL21–33–000, QF86–381–001 ...... Citrus World, Inc. E–21 ...... ER19–2547–001 ...... Pheasant Run Wind, LLC. E–22 ...... ER18–2404–000 ...... Southwest Power Pool, Inc. E–23 ...... ER19–477–000 ...... Southwest Power Pool, Inc. E–24 ...... ER21–502–001 ...... Independent System Operator, Inc.

Gas

G–1 ...... Omitted G–2 ...... RP21–153–000 ...... Texas Eastern Transmission, LP.

HYDRO

H–1 ...... P–405–106 P–405–121 ...... Exelon Generation Company, LLC. H–2 ...... P–12726–002 ...... Warm Springs Hydro LLC

Certificates

C–1 ...... RM20–18–000 ...... Waiver of the Water Quality Certification Requirements of Section 401(a)(1) of the Clean Water Act. C–2 ...... CP20–466–000 ...... New Fortress Energy LLC. C–3 ...... CP20–487–000 ...... Northern Natural Gas Company. C–4 ...... CP17–40–000, CP17–40–001 ...... Spire STL Pipeline LLC. C–5 ...... CP17–458–000, CP19–17–000 ...... Midship Pipeline Company, LLC. C–6 ...... IN19–4–000 ...... Rover Pipeline, LLC and Energy Transfer Partners, L.P.

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Issued: March 11, 2021. Description: Baseline eTariff Filing: g. Filed Pursuant to: Federal Power Nathaniel J. Davis, Sr., Crystal Lake Wind Energy III, LLC Act 16 U.S.C. 791(a)–825(r). Deputy Secretary. Application for MBR Authority to be h. Applicant Contact: Ms. Kelly effective 5/10/2021. The public is invited to listen to the Sackheim, 32151 Sandy Hollow Road, Filed Date: 3/10/21. meeting live at http:// Philadelphia, NY 13673; (916) 877– Accession Number: 20210310–5210. ferc.capitolconnection.org/. Anyone 5947; [email protected]. Comments Due: 5 p.m. ET 3/31/21. with internet access who desires to hear i. FERC Contact: Chris Millard at this event can do so by navigating to The filings are accessible in the (202) 502–8256, or christopher.millard@ www.ferc.gov’s Calendar of Events and Commission’s eLibrary system (https:// ferc.gov. locating this event in the Calendar. The elibrary.ferc.gov/idmws/search/ j. Cooperating agencies: Federal, state, event will contain a link to its audio fercgensearch.asp) by querying the local, and tribal agencies with webcast. The Capitol Connection docket number. jurisdiction and/or special expertise provides technical support for this free Any person desiring to intervene or with respect to environmental issues audio webcast. It will also offer access protest in any of the above proceedings that wish to cooperate in the to this event via phone bridge for a fee. must file in accordance with Rules 211 preparation of the environmental If you have any questions, visit http:// and 214 of the Commission’s document should follow the ferc.capitolconnection.org/ or contact Regulations (18 CFR 385.211 and instructions for filing such requests Shirley Al-Jarani at 703–993–3104. 385.214) on or before 5:00 p.m. Eastern described in item l below. Cooperating time on the specified comment date. agencies should note the Commission’s [FR Doc. 2021–05492 Filed 3–12–21; 11:15 am] Protests may be considered, but policy that agencies that cooperate in BILLING CODE 6717–01–P intervention is necessary to become a the preparation of the environmental party to the proceeding. document cannot also intervene. See 94 eFiling is encouraged. More detailed FERC ¶ 61,076 (2001). DEPARTMENT OF ENERGY information relating to filing k. Pursuant to section 4.32(b)(7) of 18 Federal Energy Regulatory requirements, interventions, protests, CFR of the Commission’s regulations, if Commission service, and qualifying facilities filings any resource agency, Indian Tribe, or can be found at: http://www.ferc.gov/ person believes that an additional Combined Notice of Filings #2 docs-filing/efiling/filing-req.pdf. For scientific study should be conducted in other information, call (866) 208–3676 order to form an adequate factual basis Take notice that the Commission (toll free). For TTY, call (202) 502–8659. for a complete analysis of the received the following exempt application on its merit, the resource wholesale generator filings: Dated: March 10, 2021. Kimberly D. Bose, agency, Indian Tribe, or person must file Docket Numbers: EG21–104–000. a request for a study with the Secretary. Applicants: Crystal Lake Wind Energy Commission not later than 60 days from III, LLC. [FR Doc. 2021–05386 Filed 3–15–21; 8:45 am] the date of filing of the application, and Description: Notice of Self- BILLING CODE 6717–01–P serve a copy of the request on the Certification of Exempt Wholesale applicant. Generator Status of Crystal Lake Wind DEPARTMENT OF ENERGY l. Deadline for filing additional study Energy III, LLC. requests and requests for cooperating Filed Date: 3/8/21. agency status: April 30, 2021. Accession Number: 20210308–5276. Federal Energy Regulatory Commission The Commission strongly encourages Comments Due: 5 p.m. ET 3/29/21. electronic filing. Please file additional Take notice that the Commission [Project No. 5728–021] study requests and requests for received the following electric rate cooperating agency status using the Sandy Hollow Hydroelectric Company, filings: Commission’s eFiling system at https:// Inc.; Notice of Application Tendered Docket Numbers: ER19–465–000; ferconline.ferc.gov/FERCOnline.aspx. for Filing With the Commission and ER19–465–001; ER19–465–003; ER19– For assistance, please contact FERC Soliciting Additional Study Requests 465–004. Online Support at and Establishing Procedural Schedule Applicants: Midcontinent [email protected], (866) for Relicensing and a Deadline for Independent System Operator, Inc. 208–3676 (toll free), or (202) 502–8659 Submission of Final Amendments Description: Midcontinent (TTY). In lieu of electronic filing, you Independent System Operator, Inc. Take notice that the following may submit a paper copy. Submissions submits Request to Defer Effective Date hydroelectric application has been filed sent via the U.S. Postal Service must be of Compliance with Order No. 841. with the Commission and is available addressed to: Kimberly D. Bose, Filed Date: 3/4/21. for public inspection. Secretary, Federal Energy Regulatory Accession Number: 20210304–5215. a. Type of Application: Subsequent Commission, 888 First Street NE, Room Comments Due: 5 p.m. ET 3/19/21. Minor License. 1A, Washington, DC 20426. Docket Numbers: ER19–2858–001. b. Project No.: 5728–021. Submissions sent via any other carrier Applicants: East Coast Power Linden c. Date filed: March 1, 2021. must be addressed to: Kimberly D. Bose, Holding, L.L.C. d. Applicant: Sandy Hollow Secretary, Federal Energy Regulatory Description: Report Filing: Refund Hydroelectric Company, Inc. (Sandy Commission, 12225 Wilkins Avenue, Report to be effective N/A. Hollow Hydro). Rockville, Maryland 20852. All filings Filed Date: 3/10/21. e. Name of Project: Sandy Hollow must clearly identify the project name Accession Number: 20210310–5077. Hydroelectric Project. and docket number on the first page: Comments Due: 5 p.m. ET 3/31/21. f. Location: On the Indian River, in Sandy Hollow Hydroelectric Project (P– Docket Numbers: ER21–1320–000. the Town of Philadelphia in Jefferson 5728–021). Applicants: Crystal Lake Wind Energy County, New York. The project does not m. The application is not ready for III, LLC. occupy any federal land. environmental analysis at this time.

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n. Project Description: The existing the proceeding (e.g., license application) Chalk Point Power, LLC ...... EG21–50–000 Sandy Hollow Hydroelectric Project via the internet through the Flat Ridge 2 Wind Energy EG21–51–000 consists of (1) a 20-acre reservoir at a Commission’s Home Page (http:// LLC. normal pool elevation of 419.1 feet www.ferc.gov) using the ‘‘eLibrary’’ link. Harry Allen Solar Energy EG21–52–000 National Geodetic Vertical Datum of Enter the docket number excluding the LLC. Centerfield Cooper Solar, EG21–53–000 1929; (2) a main 106-foot-long concrete last three digits in the docket number LLC. gravity dam with a maximum height of field to access the document (P–5728). PGR Lessee O, LLC ...... EG21–54–000 25 feet that includes a 55-foot-long At this time, the Commission has Dry Lake Solar Holdings EG21–55–000 spillway, and three 3- to 4-foot-high suspended access to the Commission’s LLC. concrete diversion spillway dams that Public Reference Room due to the HO Clarke II, LLC ...... EG21–57–000 are 21 feet, 46 feet and 64 feet long, proclamation declaring a National Indiana Crossroads Wind EG21–58–000 respectively; (3) a 23-foot-long by 23- Emergency concerning the Novel Farm LLC. foot-wide brick and concrete Coronavirus Disease (COVID–19) issued Wallingford Renewable En- EG21–59–000 powerhouse containing a 150-kilowatt by the President on March 13, 2020. For ergy LLC. (kW), a 265-kW, and a 400-kW turbine- Topaz II, LLC ...... EG21–60–000 assistance, contact FERC at Braes Bayou Generating, EG21–61–000 generator unit; (4) two 12- to 15-foot- [email protected] or call LLC. long, 6-foot-diameter steel penstocks, toll-free, (866) 208–3676 or (202) 502– KCE TX 23, LLC ...... EG21–62–000 with one penstock that bifurcates before 8659 (TTY). Midway-Sunset Cogenera- EG21–63–000 joining the two turbine units; (5) two You may also register online at tion Company. trash racks; (6) a 400-foot-long tailrace https://ferconline.ferc.gov/ Take notice that during the month of channel; (7) a 480-volt, 300-foot-long FERCOnline.aspx to be notified via February 2021, the status of the above- transmission line connecting to a 480- email of new filings and issuances captioned entities as Exempt Wholesale volt to 23-kilovolt step-up transformer at related to this or other pending projects. Generators became effective by a nearby substation; and (8) appurtenant For assistance, contact FERC Online operation of the Commission’s facilities. The average annual generation Support. regulations. 18 CFR 366.7(a) (2020). was 933 megawatt-hours between 2012 p. Procedural schedule: The and 2017. application will be processed according Dated: March 10, 2021. The project is operated in a run-of- to the following preliminary schedule. Kimberly D. Bose, river mode and discharges a minimum Revisions to the schedule will be made Secretary. flow of 35 cubic feet per second (cfs) or as appropriate. [FR Doc. 2021–05388 Filed 3–15–21; 8:45 am] inflow to the reservoir, whichever is Issue Deficiency Letter (if April 2021 BILLING CODE 6717–01–P less, into the project’s bypassed reach necessary). for the protection and enhancement of Request Additional Informa- April 2021 aquatic resources. tion. DEPARTMENT OF ENERGY As part of the license application, Issue Acceptance Letter ...... July 2021 Sandy Hollow Hydro filed a settlement Issue Scoping Document 1 August 2021 Federal Energy Regulatory agreement entered into between itself, for comments. Commission the U.S. Fish and Wildlife Service, and Request Additional Informa- October 2021 the New York State Department of tion (if necessary). [Project No. 15060–000] Issue Scoping Document 2 .. November Environmental Conservation. As part of 2021 Kinet, Inc.; Notice of Preliminary the settlement agreement, Sandy Hollow Issue Notice of Ready for November Permit Application Accepted For Filing Hydro proposes to: (1) Continue to Environmental Analysis. 2021 and Soliciting Comments, Motions To operate the project in a run-of-river q. Final amendments to the Intervene, and Competing Applications mode; (2) provide a year-round application must be filed with the minimum flow in the bypassed reach of On December 3, 2020, Kinet, Inc., Commission no later than 30 days from 35 cfs, or inflow, whichever is less; (3) filed an application for a preliminary the issuance date of the notice of ready continue the existing stream flow and permit, pursuant to section 4(f) of the for environmental analysis. water level monitoring; (4) maintain the Federal Power Act (FPA), proposing to existing trash rack on turbine unit 3 Dated: March 10, 2021. study the feasibility of a conventional with 1-inch clear spacing and, within 5 Kimberly D. Bose, hydropower project located in years of any license issued for the Secretary. Jessamine, Woodford, and Mercer project, install trash racks with either [FR Doc. 2021–05389 Filed 3–15–21; 8:45 am] Counties, Kentucky. The sole purpose of 1-inch clear spacing or the equivalent BILLING CODE 6717–01–P a preliminary permit, if issued, is to (e.g., an overlay-type system) on turbine grant the permit holder priority to file units 1 and 2; (5) within 3 years of the a license application during the permit effective date of any license issued for DEPARTMENT OF ENERGY term. A preliminary permit does not the project, install and maintain a year- authorize the permit holder to perform round downstream fish passage Federal Energy Regulatory any land-disturbing activities or structure at one of the three diversion Commission otherwise enter upon lands or waters spillway dams; (6) maintain the existing owned by others without the owners’ Notice of Effectiveness of Exempt portage trail; and (7) implement the express permission. Invasive Species Management Plan filed Wholesale Generator Status The proposed Kentucky River Lock with the final license application. Wolf Ridge Wind Energy, EG21–43–000 and Dam No. 6 Hydroelectric Project o. In addition to publishing the full LLC. would consist of the following: (1) An text of this notice in the Federal Blue Summit I Wind, LLC ... EG21–44–000 Dickerson Power, LLC ...... EG21–45–000 existing 465-foot-long, 34-foot-high, Register, the Commission provides all Morgantown Power, LLC ..... EG21–46–000 timber crib dam with concrete overlay interested persons an opportunity to Morgantown Station, LLC .... EG21–47–000 connected to a 280-foot-long, and 45- view and/or print the contents of this Water Strider Solar, LLC ..... EG21–48–000 foot-wide abandoned navigation lock, notice, as well as other documents in 325MK 8ME LLC ...... EG21–49–000 which are owned by the Kentucky River

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Authority; (2) a reservoir with a surface Dated: March 10, 2021. Comments Due: 5 p.m. ET 3/18/21. area of 666 acres and a storage capacity Kimberly D. Bose, Docket Numbers: ER21–1249–001. of 12,000 acre-feet; (3) five, proposed, Secretary. Applicants: Vineyard Reliability LLC. 32-foot-long, 9-foot-diameter penstocks [FR Doc. 2021–05384 Filed 3–15–21; 8:45 am] Description: Tariff Amendment: connected to five generating units with BILLING CODE 6717–01–P Vineyard_Rel_MBRA_App_Supp to be a combined capacity of 2.1 megawatts, effective 3/5/2021. within the existing lock; (4) a proposed Filed Date: 3/10/21. powerhouse/control room adjacent to DEPARTMENT OF ENERGY Accession Number: 20210310–5000. the lock; (5) a 30-foot-long by 63-foot- Comments Due: 5 p.m. ET 3/24/21. wide tailrace; and (6) a 270-foot-long, Federal Energy Regulatory Docket Numbers: ER21–1310–000. 12.47 kilo-Volt transmission line. The Commission Applicants: PJM Interconnection, proposed project would have an Combined Notice of Filings #1 L.L.C. estimated annual generation of 13,998 Description: Tariff Cancellation: megawatt-hours. Take notice that the Commission Notice of Cancellation of ISA, SA No. Applicant Contact: Dan Panko, Kinet, received the following exempt 4730; Queue No. AC1–039 to be Inc., 2401 Monarch Street, Alameda, CA wholesale generator filings: effective 4/26/2021. Filed Date: 3/9/21. 9401; phone: (802) 578–7973. Docket Numbers: EG21–105–000. Applicants: Elara Energy Project, LLC. Accession Number: 20210309–5166. FERC Contact: Joshua Dub; phone: Description: Elara Energy Project, LLC Comments Due: 5 p.m. ET 3/30/21. (202) 502–8138. submits Notice of Self-Certification of Docket Numbers: ER21–1312–000. Deadline for filing comments, motions Exempt Wholesale Generator Status. Applicants: New York State Electric & to intervene, competing applications Filed Date: 3/4/21. Gas Corporation, New York (without notices of intent), or notices of Accession Number: 20210304–5214. Independent System Operator, Inc. intent to file competing applications: 60 Comments Due: 5 p.m. ET 3/25/21. Description: § 205(d) Rate Filing: 205: days from the issuance of this notice. Docket Numbers: EG21–106–000. NYISO–NYSEG Joint LGIA 2487 among Competing applications and notices of Applicants: Taygete Energy Project II, NYISO, NYSEG, Baron Winds to be intent must meet the requirements of 18 LLC. effective 2/24/2021. CFR 4.36. Description: Notice of Self- Filed Date: 3/10/21. Accession Number: 20210310–5051. The Commission strongly encourages Certification of Exempt Wholesale Comments Due: 5 p.m. ET 3/31/21. electronic filing. Please file comments, Generator Status of Taygete Energy motions to intervene, notices of intent, Project II, LLC. Docket Numbers: ER21–1314–000. Filed Date: 3/10/21. Applicants: Tri-State Generation and and competing applications using the Accession Number: 20210310–5068. Transmission Association, Inc. Commission’s eFiling system at https:// Comments Due: 5 p.m. ET 3/31/21. Description: § 205(d) Rate Filing: ferconline.ferc.gov/FERCOnline.aspx. Amendment to Service Agreement No. Commenters can submit brief comments Take notice that the Commission received the following electric rate 849 to be effective 2/11/2021. up to 6,000 characters, without prior Filed Date: 3/10/21. registration, using the eComment system filings: Docket Numbers: ER10–2034–007; Accession Number: 20210310–5091. at https://ferconline.ferc.gov/ Comments Due: 5 p.m. ET 3/31/21. QuickComment.aspx. You must include ER15–190–016; ER18–490–000. Docket Numbers: ER21–1315–000. your name and contact information at Applicants: Duke Energy Renewable Applicants: Midcontinent the end of your comments. For Services, LLC, Duke Energy Indiana, LLC. Independent System Operator Inc., assistance, please contact FERC Online American Transmission Company LLC. Support at FERCOnlineSupport@ Description: Supplement to December 18, 2020 Triennial Market Power Description: § 205(d) Rate Filing: ferc.gov, (866) 208–3676 (toll free), or Analysis for Central Region of Duke 2021–03–10_SA 2775 ATC-Marshfield (202) 502–8659 (TTY). In lieu of Companies. 1st Rev CFA to be effective 5/10/2021. electronic filing, you may submit a Filed Date: 3/4/21. Filed Date: 3/10/21. paper copy. Submissions sent via the Accession Number: 20210304–5210. Accession Number: 20210310–5106. U.S. Postal Service must be addressed Comments Due: 5 p.m. ET 3/25/21. Comments Due: 5 p.m. ET 3/31/21. to: Kimberly D. Bose, Secretary, Federal Docket Numbers: ER18–126–001; Docket Numbers: ER21–1316–000. Energy Regulatory Commission, 888 ER16–2019–005. Applicants: Louisville Gas and First Street NE, Room 1A, Washington, Applicants: AL Solar A, LLC, Five Electric Company. DC 20426. Submissions sent via any Points Solar Park LLC. Description: § 205(d) Rate Filing: other carrier must be addressed to: Description: Notice of Non-Material EKPC Bullitt County CIAC Agreement to Kimberly D. Bose, Secretary, Federal Change in Status of AL Solar A, LLC, et be effective 3/10/2021. Energy Regulatory Commission, 12225 al. Filed Date: 3/10/21. Wilkins Avenue, Rockville, Maryland Filed Date: 3/9/21. Accession Number: 20210310–5138. 20852. Accession Number: 20210309–5195. Comments Due: 5 p.m. ET 3/31/21. More information about this project, Comments Due: 5 p.m. ET 3/30/21. Docket Numbers: ER21–1317–000. including a copy of the application, can Docket Numbers: ER21–1176–000. Applicants: Kentucky Utilities be viewed or printed on the ‘‘eLibrary’’ Applicants: Delta’s Edge Solar, LLC. Company. link of the Commission’s website at Description: Delta’s Edge Solar, LLC Description: § 205(d) Rate Filing: KU https://elibrary.ferc.gov/eLibrary/search. submits Supplemental Information Concurrence EKPC Bullitt County CIAC Enter the docket number (P–15060) in Regarding the Application for Market Agreement to be effective 3/10/2021. the docket number field to access the Based Rate Authority. Filed Date: 3/10/21. document. For assistance, contact FERC Filed Date: 2/25/21. Accession Number: 20210310–5139. Online Support. Accession Number: 20210225–5221. Comments Due: 5 p.m. ET 3/31/21.

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Take notice that the Commission Morgan Stanley Capital to be effective 4/ Docket Numbers: RP21–614–000. received the following public utility 1/2021. Applicants: Devon Energy Production holding company filings: Filed Date: 3/5/21. Company, L.P., Denbury Onshore, LLC. Docket Numbers: PH21–8–000. Accession Number: 20210305–5004. Description: Petition For Limited Applicants: Greenidge Generation Comments Due: 5 p.m. ET 3/17/21. Waiver, et al. of Devon Energy Holdings Inc., Atlas Capital Resources Docket Numbers: RP21–609–000. Production Company, L.P., et al. under (A9-Parallel) LP. Applicants: Natural Gas Pipeline RP21–614. Description: Greenidge Generation Company of America. Filed Date: 3/9/21. Holdings Inc. et al., submits FERC–65– Description: § 4(d) Rate Filing: Accession Number: 20210309–5105. A Exemption Notification. Negotiated Rate Agreements Filing— Comments Due: 5 p.m. ET 3/16/21. Filed Date: 3/9/21. Wells Fargo Commodities to be effective Docket Numbers: RP21–615–000. Accession Number: 20210309–5194. 4/1/2021. Applicants: Enable Gas Transmission, Comments Due: 5 p.m. ET 3/30/21. Filed Date: 3/5/21. LLC. The filings are accessible in the Accession Number: 20210305–5005. Description: § 4(d) Rate Filing: Commission’s eLibrary system (https:// Comments Due: 5 p.m. ET 3/17/21. Negotiated Rate Filing—March 9, 2021 elibrary.ferc.gov/idmws/search/ Docket Numbers: RP21–610–000. GEP to be effective 3/9/2021. fercgensearch.asp) by querying the Applicants: Adelphia Gateway, LLC. Filed Date: 3/9/21. docket number. Description: Penalty Revenue Accession Number: 20210309–5139. Any person desiring to intervene or Crediting Report of Adelphia Gateway, Comments Due: 5 p.m. ET 3/22/21. protest in any of the above proceedings LLC under RP21–610. Docket Numbers: RP21–616–000. must file in accordance with Rules 211 Filed Date: 3/8/21. Applicants: Panhandle Eastern Pipe and 214 of the Commission’s Accession Number: 20210308–5206. Line Company, LP. Regulations (18 CFR 385.211 and Comments Due: 5 p.m. ET 3/22/21. Description: Request for Limited 385.214) on or before 5:00 p.m. Eastern Docket Numbers: RP21–611–000. Waiver Determination of Panhandle time on the specified comment date. Applicants: Enable Gas Transmission, Eastern Pipe Line Company, LP under Protests may be considered, but LLC. RP21–616. intervention is necessary to become a Description: Petition for Limited Filed Date: 3/9/21. party to the proceeding. Waiver of Tariff Provision of Enable Gas Accession Number: 20210309–5175. eFiling is encouraged. More detailed Transmission, LLC under RP21–611. Comments Due: 5 p.m. ET 3/16/21. information relating to filing Filed Date: 3/8/21. The filings are accessible in the requirements, interventions, protests, Accession Number: 20210308–5233. Commission’s eLibrary system (https:// service, and qualifying facilities filings Comments Due: 5 p.m. ET 3/15/21. elibrary.ferc.gov/idmws/search/ can be found at: http://www.ferc.gov/ Docket Numbers: RP13–459–000. fercgensearch.asp) by querying the docs-filing/efiling/filing-req.pdf. For Applicants: Trailblazer Pipeline docket number. other information, call (866) 208–3676 Company LLC. Any person desiring to intervene or (toll free). For TTY, call (202) 502–8659. Description: Report Filing: TPC 2021– protest in any of the above proceedings Dated: March 10, 2021. 03–09 2020 Penalty Revenues Refund must file in accordance with Rules 211 Kimberly D. Bose, Report. and 214 of the Commission’s Secretary. Filed Date: 3/9/21. Regulations (18 CFR 385.211 and [FR Doc. 2021–05385 Filed 3–15–21; 8:45 am] Accession Number: 20210309–5098. 385.214) on or before 5:00 p.m. Eastern BILLING CODE 6717–01–P Comments Due: 5 p.m. ET 3/22/21. time on the specified comment date. Docket Numbers: RP21–555–001. Protests may be considered, but Applicants: Destin Pipeline Company, intervention is necessary to become a DEPARTMENT OF ENERGY L.L.C. party to the proceeding. Description: Tariff Amendment: eFiling is encouraged. More detailed Federal Energy Regulatory Destin Pipeline Amended Negotiated information relating to filing Commission Rate Filing to be effective 4/1/2021. requirements, interventions, protests, Filed Date: 3/9/21. service, and qualifying facilities filings Combined Notice of Filings Accession Number: 20210309–5146. can be found at: http://www.ferc.gov/ Take notice that the Commission has Comments Due: 5 p.m. ET 3/22/21. docs-filing/efiling/filing-req.pdf. For received the following Natural Gas Docket Numbers: RP21–612–000. other information, call (866) 208–3676 Pipeline Rate and Refund Report filings: Applicants: Vector Pipeline L.P. (toll free). For TTY, call (202) 502–8659. Docket Numbers: RP21–607–000. Description: Vector Pipeline L.P. Dated: March 10, 2021. Applicants: Natural Gas Pipeline submits Annual Fuel Use Report for Kimberly D. Bose, Company of America. 2020 under RP21–612. Secretary. Description: § 4(d) Rate Filing: Filed Date: 3/9/21. [FR Doc. 2021–05387 Filed 3–15–21; 8:45 am] Negotiated Rate Agreement Filing—BP Accession Number: 20210309–5044. BILLING CODE 6717–01–P Energy Company to be effective 4/1/ Comments Due: 5 p.m. ET 3/22/21. 2021. Docket Numbers: RP21–613–000. Filed Date: 3/5/21. Applicants: Midcontinent Express FEDERAL COMMUNICATIONS Accession Number: 20210305–5003. Pipeline LLC. COMMISSION Comments Due: 5 p.m. ET 3/17/21. Description: Compliance filing Docket Numbers: RP21–608–000. Annual Report of Operational Purchases [FR ID: 17566] Applicants: Natural Gas Pipeline and Sales 2021. Privacy Act of 1974; Matching Program Company of America. Filed Date: 3/9/21. Description: § 4(d) Rate Filing: Accession Number: 20210309–5045. AGENCY: Federal Communications Negotiated Rate Agreement Filing— Comments Due: 5 p.m. ET 3/22/21. Commission.

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ACTION: Notice of a new matching of COVID–19. A household may qualify a variety of Lifeline participants, program. for the EBBP benefit under various including Lifeline providers, criteria, including an individual subscribers, states, community-based SUMMARY: In accordance with the qualifying for the FCC’s Lifeline organizations, USAC, and the Privacy Act of 1974, as amended program. Commission.’’ 31 FCC Rcd 3962, 4006, (‘‘Privacy Act’’), this document In a Report and Order adopted on para. 126. To help determine whether announces the modification of a March 31, 2016 (81 FR 33026 (May 24, Lifeline applicants and subscribers are computer matching program the Federal 2016)), the Commission ordered USAC eligible for Lifeline benefits, the Order Communications Commission (‘‘FCC’’ to create a National Lifeline Eligibility contemplates that the USAC-operated or ‘‘Commission’’ or ‘‘Agency’’) and the Verifier (‘‘National Verifier’’), including LED will communicate with information Universal Service Administrative the National Lifeline Eligibility Database systems and databases operated by other Company (USAC) will conduct with the (LED), that would match data about Federal and State agencies. Id. at 4011– U.S. Department of Health and Human Lifeline applicants and subscribers with 2, paras. 135–7. The Consolidated Services, Centers for Medicare & other data sources to verify the Appropriations Act of 2021 directs the Medicaid Services (CMS) (‘‘Agency’’). eligibility of an applicant or subscriber. FCC to leverage the National Verifier to The purpose of this matching program The Commission found that the verify applicants’ eligibility for EBBP. is to verify the eligibility of applicants National Verifier would reduce The purpose of this modified to and subscribers of Lifeline (existing compliance costs for Lifeline service matching agreement is to verify the purpose) and the new Emergency providers, improve service for Lifeline eligibility of applicants and subscribers Broadband Benefit Program, both of subscribers, and reduce waste, fraud, to Lifeline (existing purpose), as well as which are administered by USAC under and abuse in the program. to the new EBBP and to other Federal the direction of the FCC. More The Consolidated Appropriations Act programs that use qualification for information about these programs is of 2021 directs the FCC to leverage the Lifeline as an eligibility criterion. This provided in the SUPPLEMENTARY National Verifier to verify applicants’ new agreement would replace the INFORMATION section below. eligibility for EBBP. The purpose of this existing agreement with CMS, which DATES: Written comments are due on or matching program is to verify the permits matching only for the Lifeline before April 15, 2021. This computer eligibility of EBBP applicants and program by checking an applicant’s/ matching program will commence on subscribers by determining whether subscriber’s participation in Medicaid. April 15, 2021, and will conclude 18 they receive Medicaid or Supplemental Under FCC rules, consumers receiving months after the effective date. Nutrition Assistance Program (SNAP) these benefits qualify for Lifeline ADDRESSES: Send comments to Margaret benefits administered by the U.S. discounts and also for EBBP benefits. Department of Health and Human Drake, FCC, 45 L Street NE, Washington, Categories of Individuals DC 20554, or to [email protected]. Services, Centers for Medicare & The categories of individuals whose FOR FURTHER INFORMATION CONTACT: Medicaid Services. Under FCC rules, information is involved in the matching Margaret Drake at 202–418–1707 or consumers receiving these benefits program include, but are not limited to, [email protected]. qualify for Lifeline discounts and also for EBBP benefits. those individuals who have applied for SUPPLEMENTARY INFORMATION: The Lifeline and/or EBBP benefits; are Lifeline program provides support for Participating Non-Federal Agencies currently receiving Lifeline and/or discounted broadband and voice U.S. Department of Health and EBBP benefits; are individuals who services to low-income consumers. Human Services, Centers for Medicare & enable another individual in their Lifeline is administered by the Medicaid Services. household to qualify for Lifeline and/or Universal Service Administrative EBBP benefits; are minors whose status Authority for Conducting the Matching Company (USAC) under FCC direction. qualifies a parent or guardian for Progam Consumers qualify for Lifeline through Lifeline and/or EBBP benefits; or are proof of income or participation in a The authority for the FCC’s EBBP is individuals who have received Lifeline qualifying program, such as Medicaid, Consolidated Appropriations Act of and/or EBBP benefits. the Supplemental Nutritional 2021, Public Law 116–260, 134 Stat. Assistance Program (SNAP), Federal 1182; 47 CFR part 54, subpart P. The Categories of Records Public Housing Assistance, authority for the FCC’s Lifeline program The categories of records involved in Supplemental Security Income (SSI), is 47 U.S.C. 254; 47 CFR part 54, subpart the matching program include, but are Veterans and Survivors Pension Benefit, E; Lifeline and Link Up Reform and not limited to, the last four digits of the or various Tribal-specific Federal Modernization, et al., Third Report and applicant’s Social Security Number, assistance programs. Order, Further Report and Order, and date of birth, state of residence, first The Emergency Broadband Benefit Order on Reconsideration, 31 FCC Rcd name, and last name. The National Program (EBBP) was established by 3962, 4006–21, paras. 126–66 (2016) (81 Verifier will transfer these data elements Congress in the Consolidated FR 33026 (May 24, 2016) (2016 Lifeline to the U.S. Department of Health and Appropriations Act of 2021, Public Law Modernization Order). Human Services, Centers for Medicare & 116–260, 134 Stat. 1182. EBBP is a Medicaid Services which will respond Purposes(s) program that will help low-income either ‘‘yes’’ or ‘‘no’’ that the individual Americans obtain discounted broadband In the 2016 Lifeline Modernization is enrolled in a qualifying assistance service and one-time co-pay for a Order, the FCC required USAC to program: U.S. Department of Health and connected device (laptop, desktop develop and operate the National Human Services, Centers for Medicare & computer or tablet). This program was Verifier to improve efficiency and Medicaid Services, Medicaid. created specifically to assist American reduce waste, fraud, and abuse in the families’ access to broadband, which Lifeline program. The stated purpose of System(s) of Records has proven to be essential for work, the National Verifier is ‘‘to increase the The records shared as part of this school, and healthcare during the public integrity and improve the performance matching program reside in the Lifeline health emergency that exists as a result of the Lifeline program for the benefit of system of records, FCC/WCB–1,

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Lifeline, which was published in the and the Supplementary Document, administrative, technical, and physical Federal Register at 86 FR 11526 (Feb. which includes details of the safeguards; and updated notification, 25, 2021). modifications to this system of records). records access, and procedures to The records shared as part of this SUPPLEMENTARY INFORMATION: The contest records. matching program reside in the EBBP Wireless Telecommunications Bureau SYSTEM NAME AND NUMBER: system of records, FCC/WCB–3, (WTB) uses the information in FCC/ Emergency Broadband Benefit Program, WTB–7 to record and process requests FCC/WTB–7, LICENSING AND which was published in the Federal for assistance from individuals or RELATED SUPPORT SERVICES. Register at 86 FR 11523 (Feb. 25, 2021). groups in connection with FCC systems, SECURITY CLASSIFICATION: Federal Communications Commission. research tools, electronic databases, Marlene Dortch, licenses, authorizations, and Unclassified. registrations. Secretary. SYSTEM LOCATION: This notice serves to modify FCC/ [FR Doc. 2021–05424 Filed 3–15–21; 8:45 am] WTB–7 to reflect various necessary Wireless Telecommunications Bureau BILLING CODE 6712–01–P changes and updates, which include (WTB), Federal Communications clarification of the purpose of the Commission (FCC), Washington, DC FEDERAL COMMUNICATIONS system, format changes required by 20554. COMMISSION OMB Circular A–108 since its previous publication, the revision of five Routine SYSTEMS MANAGER(S) AND ADDRESS: [FRS 17568] Uses, and the addition of two new Wireless Telecommunications Bureau Routine Uses. The substantive changes (WTB), Federal Communications Privacy Act of 1974; System of and modification to the previously Commission (FCC), Washington, DC Records published version of FCC/WTB–7 20554. (formerly FCC/WTB–7, Remedy Action AGENCY: Federal Communications AUTHORITY FOR MAINTENANCE OF THE SYSTEM: Commission. Request System (RARS)) system of records include: 47 U.S.C. 151, 154, 208, 258, 301, 303, ACTION: Notice of a modified system of 1. Changing the name of the system of 309(e), and 312. records. records to FCC/WTB–7, Licensing and PURPOSE(S) OF THE SYSTEM: SUMMARY: The Federal Communications Related Support Services. Commission (FCC, Commission, or 2. Updating the Security The FCC staff uses the records in this Agency) has modified an existing Classification to follow OMB and FCC system to process requests for assistance system of records, FCC/WTB–7, guidance. from individuals or groups in Licensing and Related Support Services 3. Clarifying the Purpose for the connection with FCC systems, research (formerly FCC/WTB–7, Remedy Action system. tools, electronic databases, licenses, Request System (RARS)), subject to the 4. Updating and/or revising language authorizations, and registrations. Privacy Act of 1974, as amended. This in six Routine Uses: (1) Third Parties, (2) Adjudication and Litigation, (3) Law CATEGORIES OF INDIVIDUALS COVERED BY THE action is necessary to meet the SYSTEM: requirements of the Privacy Act to Enforcement and Investigation, (4) publish in the Federal Register notice of Congressional Inquiries, (5) The categories of individuals in the the existence and character of records Government-wide Program Management system include individuals who request maintained by the Agency. The FCC and Oversight, and (6) Breach assistance in connection with FCC uses this information to record and Notification, the changes to this routine systems, research tools, electronic process requests for assistance from required by OMB Memorandum M–17– databases, licenses, authorizations, and individuals or groups in connection 12. registrations. 6. Adding two new Routine Uses: (7) with FCC systems, research tools, CATEGORIES OF RECORDS IN THE SYSTEM: electronic databases, licenses, Assistance to Federal Agencies and authorizations, and registrations. Entities, to allow the FCC to provide The categories of records in the system include: DATES: This action will become effective assistance to other Federal agencies in 1. Requests for assistance by the on March 16, 2021. Written comments their data breach situations, as required requester’s first name, last name, on the system’s routine uses are due by by OMB Memorandum M–17–12; and telephone number and extension, April 15, 2021. The routine uses in this (8) For Non-Federal Personnel, to allow international telephone number and action will become effective on April contractors performing or working on a extension, email address(es), computer 15, 2021, unless written comments are contract for the Federal Government operating system, web browser, FCC received that require a contrary access to information in this system. Registration Number (FRN), and determination. 7. Adding two new sections: Reporting to a Consumer Reporting personal security question and answer. ADDRESSES: Send comments to Privacy Agency, to address valid and overdue 2. Records verifying identity Team, Office of General Counsel, debts owed by individuals to the FCC information by the individual’s first Federal Communications Commission under the Debt Collection Act, as name, last name, contact telephone (FCC), 45 L Street NE, Washington, DC recommended by OMB; and a History number, FRN, and personal security 20554 or [email protected]. section referencing the previous question and answer. FOR FURTHER INFORMATION CONTACT: publication of this SORN in the Federal Margaret Drake, Privacy Team, Office of Register, as required by OMB Circular RECORD SOURCE CATEGORIES: General Counsel, Federal A–108. Information in this system is provided Communications Commission, 45 L The system of records is also updated by users who request assistance in Street NE, Washington, DC 20554, 202– to reflect various administrative changes connection with FCC systems, research 418–1707, or [email protected] (and to related to the policy and practices for tools, electronic databases, licenses, obtain a copy of the Narrative Statement storage and retrieval of the information; authorizations, and registrations.

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ROUTINE USES OF RECORDS MAINTAINED IN THE been a breach of PII maintained in the individual, call sign, file number, SYSTEM, INCLUDING CATEGORIES OF USERS AND system of records; (b) the Commission problem type, FRN, email address, and/ THE PURPOSES OF SUCH USES: has determined that as a result of the or subject matter. In addition to those disclosures suspected or confirmed breach there is generally permitted under 5 U.S.C. a risk of harm to individuals, the POLICIES AND PRACTICES FOR RETENTION AND 552a(b) of the Privacy Act, all or a Commission (including its information DISPOSAL OF RECORDS: portion of the records or information system, programs, and operations), the The information in the system is contained in this system may be Federal Government, or national maintained according to General disclosed to authorized entities, as is security; and, (c) the disclosure made to Records Schedules 5.8 and 6.5. The determined to be relevant and such agencies, entities, and persons is electronic records, files, and data are necessary, outside the FCC as a routine reasonably necessary to assist in destroyed physically (electronic storage use pursuant to 5 U.S.C. 552a(b)(3) as connection with the Commission’s media) or by electronic erasure. Paper follows. efforts to respond to the suspected or documents are destroyed by shredding 1. Third Parties—To third parties, confirmed breach or to prevent, after they are scanned into the including Federal, state, local, or tribal minimize, or remedy such harm. information system’s electronic agencies, or entities that may be subject 7. Assistance to Federal Agencies and databases. to the Communications Act of 1934, as Entities—To another Federal agency or amended, to resolve requests for ADMINISTRATIVE, TECHNICAL, AND PHYSICAL Federal entity, when the Commission SAFEGUARDS: assistance. determines that information from this 2. Adjudication and Litigation—To system is reasonably necessary to assist The records in the FCC’s computer disclose to the Department of Justice the recipient agency or entity in: (a) network are protected by the FCC (DOJ), or to other administrative or Responding to a suspected or confirmed privacy safeguards, a comprehensive adjudicative bodies before which the breach or (b) preventing, minimizing, or and dynamic set of IT safety and FCC is authorized to appear, when: (a) remedying the risk of harm to security protocols and features that are The FCC or any component thereof; or individuals, the recipient agency or designed to meet all Federal IT privacy (b) any employee of the FCC in his or entity (including its information standards, including those required by her official capacity; or (c) any systems, program, and operations), the the Federal Information Security employee of the FCC in his or her Federal Government, or national Modernization Act of 2014 (FISMA), the individual capacity where the DOJ or security, resulting from a suspected or Office of Management and Budget the FCC have agreed to represent the confirmed breach. (OMB), and the National Institute of employee; or (d) the United States is a 8. Non-Federal Personnel—To Standards and Technology (NIST). party to litigation or has an interest in disclose information to third parties, such litigation, and the use of such RECORDS ACCESS PROCEDURES: including contractors, performing or records by the DOJ or the FCC is working on a contract in connection Individuals wishing to request access deemed by the FCC to be relevant and with resolving requests for assistance to and/or amendment of records about necessary to the litigation. and/or IT services for the Federal themselves should follow the 3. Law Enforcement and Notification Procedure below. Investigation—To disclose pertinent Government, who may require access to information to the appropriate Federal, this system of records. CONTESTING RECORD PROCEDURES: State, local, or tribal agency responsible REPORTING TO A CONSUMER REPORTING AGENCY: Individuals wishing to request an for investigating, prosecuting, enforcing, In addition to the routine uses cited amendment of records about themselves or implementing a statute, rule, above, the Commission may share should follow the Notification regulation, or order, when the FCC information from this system of records Procedure below. becomes aware of an indication of a with a consumer reporting agency NOTIFICATION PROCEDURE: violation or potential violation of civil regarding an individual who has not or criminal law or regulation. paid a valid and overdue debt owed to Individuals wishing to determine 4. Congressional Inquiries—To the Commission, following the whether this system of records contains provide information to a Congressional procedures set out in the Debt information about themselves may do so office from the record of an individual Collection Act, 31 U.S.C. 3711(e). by writing to the Privacy Team, Office in response to an inquiry from that of General Counsel, Federal Congressional office made at the written POLICIES AND PRACTICES FOR STORAGE OF Communications Commission, request of that individual. RECORDS: Washington, DC 20554, [email protected]. 5. Government-wide Program Information in the information system Individuals requesting access must Management and Oversight—To provide consists of electronic data, files, and also comply with the FCC’s Privacy Act information to the National Archives records, which are housed in the FCC’s regulations regarding verification of and Records Administration (NARA) for computer network databases. Any paper identity to gain access to the records (47 the use in its records management documents that WTB receives are CFR part 0, subpart E). inspections; to the Department of Justice scanned into the electronic database EXEMPTIONS PROMULGATED FOR THE SYSTEM: (DOJ) to obtain that department’s advice upon receipt, and then the paper regarding disclosure obligations under documents are destroyed. None. the Freedom of Information Act; or to the Office of Management and Budget POLICIES AND PRACTICES FOR RETRIEVAL OF HISTORY: (OMB) to obtain that office’s advice RECORDS: The FCC last gave full notice of this regarding obligations under the Privacy The electronic data, files, and records system of records, FCC/WTB–7, Act. may be retrieved by searching Licensing and Related Support Services 6. Breach Notification—To electronically using a variety of (formerly: FCC/WTB–7, Remedy Action appropriate agencies, entities, and parameters including the requester’s Request System (RARS)), by publication persons when: (a) The Commission name, entity name, telephone number, in the Federal Register on May 28, 2010 suspects or has confirmed that there has licensee, applicant or unlicensed (75 FR 30025).

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Federal Communications Commission. The Emergency Broadband Benefit Order on Reconsideration, 31 FCC Rcd Marlene H. Dortch, Program (EBBP) was established by 3962, 4006–21, paras. 126–66 (2016) 81 Secretary. Congress in the Consolidated FR 33026 (May 24, 2016) (2016 Lifeline [FR Doc. 2021–05425 Filed 3–15–21; 8:45 am] Appropriations Act of 2021, Public Law Modernization Order). 116–260, 134 Stat. 1182. EBBP is a BILLING CODE 6712–01–P Purpose(s) program that will help low-income Americans obtain discounted broadband In the 2016 Lifeline Modernization FEDERAL COMMUNICATIONS service and one-time co-pay for a Order, the FCC required USAC to COMMISSION connected device (laptop, desktop develop and operate the National computer or tablet). This program was Verifier to improve efficiency and [FR ID: 17565] created specifically to assist American reduce waste, fraud, and abuse in the Lifeline program. The stated purpose of Privacy Act of 1974; Matching Program families’ access to broadband, which has proven to be essential for work, the National Verifier is ‘‘to increase the AGENCY: Federal Communications school, and healthcare during the public integrity and improve the performance Commission. health emergency that exists as a result of the Lifeline program for the benefit of ACTION: Notice of a new matching of COVID–19. A household may qualify a variety of Lifeline participants, program. for the EBBP benefit under various including Lifeline providers, criteria, including an individual subscribers, states, community-based SUMMARY: In accordance with the qualifying for the FCC’s Lifeline organizations, USAC, and the Privacy Act of 1974, as amended program. Commission.’’ 31 FCC Rcd 3962, 4006, (‘‘Privacy Act’’), this document In a Report and Order adopted on para. 126. To help determine whether announces the modification of a March 31, 2016 (81 FR 33026 (May 24, Lifeline applicants and subscribers are computer matching program the Federal 2016)), the Commission ordered USAC eligible for Lifeline benefits, the Order Communications Commission (‘‘FCC’’ to create a National Lifeline Eligibility contemplates that the USAC-operated or ‘‘Commission’’ or ‘‘Agency’’) and the Verifier (‘‘National Verifier’’), including LED will communicate with information Universal Service Administrative the National Lifeline Eligibility Database systems and databases operated by other Company (USAC) will conduct with the (LED), that would match data about Federal and State agencies. Id. at 4011– Indiana Family and Social Services Lifeline applicants and subscribers with 2, paras. 135–7. The Consolidated Administration Division of Family other data sources to verify the Appropriations Act of 2021 directs the Resources (FSSA/DFR) (‘‘Agency’’). The eligibility of an applicant or subscriber. FCC to leverage the National Verifier to purpose of this matching program is to The Commission found that the verify applicants’ eligibility for EBBP. verify the eligibility of applicants to and National Verifier would reduce The purpose of this modified subscribers of Lifeline (existing compliance costs for Lifeline service matching agreement is to verify the purpose) and the new Emergency providers, improve service for Lifeline eligibility of applicants and subscribers Broadband Benefit Program, both of subscribers, and reduce waste, fraud, to Lifeline (existing purpose), as well as which are administered by USAC under and abuse in the program. to the new EBBP and to other Federal the direction of the FCC. More The Consolidated Appropriations Act programs that use qualification for information about these programs is of 2021 directs the FCC to leverage the Lifeline as an eligibility criterion. This provided in the SUPPLEMENTARY National Verifier to verify applicants’ new agreement would replace the INFORMATION section below. eligibility for EBBP. The purpose of this existing agreement with Indiana, which DATES: Written comments are due on or matching program is to verify the permits matching only for the Lifeline before April 15, 2021. This computer eligibility of EBBP applicants and program by checking an applicant’s/ matching program will commence on subscribers by determining whether subscriber’s participation in SNAP and April 15, 2021, and will conclude 18 they receive Medicaid or Supplemental Medicaid. Under FCC rules, consumers months after the effective date. Nutrition Assistance Program (SNAP) receiving these benefits qualify for ADDRESSES: Send comments to Margaret benefits administered by the Indiana Lifeline discounts and also for EBBP Drake, FCC, 45 L Street NE, Washington, Family and Social Services benefits. Administration Division of Family DC 20554, or to [email protected]. Categories of Individuals Resources. Under FCC rules, consumers FOR FURTHER INFORMATION CONTACT: receiving these benefits qualify for The categories of individuals whose Margaret Drake at 202–418–1707 or Lifeline discounts and also for EBBP information is involved in the matching [email protected]. benefits. program include, but are not limited to, SUPPLEMENTARY INFORMATION: The those individuals who have applied for Lifeline program provides support for Participating Non-Federal Agencies Lifeline and/or EBBP benefits; are discounted broadband and voice Indiana Family and Social Services currently receiving Lifeline and/or services to low-income consumers. Administration Division of Family EBBP benefits; are individuals who Lifeline is administered by the Resources. enable another individual in their Universal Service Administrative household to qualify for Lifeline and/or Authority for Conducting the Matching Company (USAC) under FCC direction. EBBP benefits; are minors whose status Program Consumers qualify for Lifeline through qualifies a parent or guardian for proof of income or participation in a The authority for the FCC’s EBBP is Lifeline and/or EBBP benefits; or are qualifying program, such as Medicaid, Consolidated Appropriations Act of individuals who have received Lifeline the Supplemental Nutritional 2021, Public Law 116–260, 134 Stat. and/or EBBP benefits. Assistance Program (SNAP), Federal 1182; 47 CFR part 54, subpart P. The Public Housing Assistance, authority for the FCC’s Lifeline program Categories of Records Supplemental Security Income (SSI), is 47 U.S.C. 254; 47 CFR part 54, subpart The categories of records involved in Veterans and Survivors Pension Benefit, E; Lifeline and Link Up Reform and the matching program include, but are or various Tribal-specific Federal Modernization, et al., Third Report and not limited to, the last four digits of the assistance programs. Order, Further Report and Order, and applicant’s Social Security Number,

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date of birth, first name, and last name. DEPARTMENT OF HEALTH AND ADDRESSES: Written comments and The National Verifier will transfer these HUMAN SERVICES recommendations for the proposed data elements to the Indiana Family and information collection should be sent Social Services Administration Division Administration for Children and within 30 days of publication of this of Family Resources which will respond Families notice to www.reginfo.gov/public/do/ either ‘‘yes’’ or ‘‘no’’ that the individual PRAMain. Find this particular is enrolled in a qualifying assistance Submission for OMB Review; Annual information collection by selecting program: Indiana Family and Social Statistical Report on Children in Foster ‘‘Currently under 30-day Review—Open Homes and Children in Families Services Administration Division of for Public Comments’’ or by using the Receiving Payment in Excess of the Family Resources, SNAP or Medicaid. search function. Poverty Income Level From a State SUPPLEMENTARY INFORMATION: System(s) of Records Program Funded Under Part A of Title Description: The Elementary and IV of the Social Security Act (OMB Secondary Education Act of 1965 The records shared as part of this #0970–0004) (ESEA), section 1124 of Title I, as matching program reside in the Lifeline amended by Public Law 114–95, system of records, FCC/WCB–1, AGENCY: Office of Family Assistance, requires the Secretary of Health and Lifeline, which was published in the Administration for Children and Human Services to determine the Federal Register at 86 FR 11526 (Feb. Families, HHS. number of children aged 5 to 17, 25, 2021). ACTION: Request for public comment. inclusive, that (1) are being supported in The records shared as part of this foster homes with public funds; or (2) matching program reside in the EBBP SUMMARY: The Office of Family are from families receiving assistance system of records, FCC/WCB–3, Assistance (OFA), Administration for payments in excess of the current Emergency Broadband Benefit Program, Children and Families, is requesting a 3- poverty income level for a family of which was published in the Federal year extension of the form ACF–4125: four. The information gathered is to be Register at 86 FR 11523 (Feb. 25, 2021). Annual Report on Children in Foster passed on to the Secretary of Education for purposes of allocating grants Federal Communications Commission. Homes and Children in Families Receiving Payment in Excess of the authorized under this law. The statute Marlene Dortch, Poverty Income Level from a State requires that the formula to allocate Secretary. Program Funded Under Part A of Title these grants and distribute funds be [FR Doc. 2021–05423 Filed 3–15–21; 8:45 am] IV of the Social Security Act (OMB based, in part, on October caseload data BILLING CODE 6712–01–P #0970–0004, expiration 3/21/2021). on the number of children in foster care There are no changes requested to the or in families receiving payments from form. state programs funded under Title IV–A of the Social Security Act [Temporary DATES: Comments due within 30 days of Assistance for Needy Families]. The publication. OMB must make a decision purpose of this annual survey is to about the collection of information provide annually updated data so that between 30 and 60 days after funds may be allocated in accordance publication of this document in the with the ESEA. Federal Register. Therefore, a comment Respondents: State agencies is best assured of having its full effect (including the District of Columbia and if OMB receives it within 30 days of Puerto Rico) administering child welfare publication. and public assistance programs.

ANNUAL BURDEN ESTIMATES

Annual number Average Instrument Total number of responses burden hours Total annual of respondents per respondent per response burden hours

Annual Report on Children in Foster Homes and Children Receiving Pay- ments ...... 52 1 264.35 13,746.20

Estimated Total Annual Burden DEPARTMENT OF HEALTH AND ACTION: Request for Public Comment. Hours: 13,746.20. HUMAN SERVICES SUMMARY: The Administration for Authority: Pub. L. 107–110 Sec: 1124(c)(4) Administration for Children and Children and Families (ACF) is and Pub. L. 104–193 Sec: 110(j). Families requesting a 3-year extension of the Mary B. Jones, Program Instruction (PI) for the ACF/OPRE Certifying Officer. Submission for OMB Review; Community-Based Family Resource and Community-Based Family Resource Support Grants or the Community- [FR Doc. 2021–05413 Filed 3–15–21; 8:45 am] and Support Grants (Name Changed to Based Child Abuse Prevention (CBCAP) BILLING CODE 4184–36–P Child Abuse Prevention Program—OIS program (OMB No.: 0970–0155, Notified 6/2007) (OMB No.: 0970–0155) expiration 3/31/2021), which outlines information collection requirements AGENCY: Children’s Bureau, pursuant to receiving a grant award. Administration on Children, Youth and There are no changes requested to the Families, HHS. information collection process.

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DATES: Comments due within 30 days of for Public Comments’’ or by using the reduce the likelihood of child abuse and publication. OMB must make a decision search function. neglect; and (2) fostering an about the collection of information SUPPLEMENTARY INFORMATION: understanding, appreciation, and between 30 and 60 days after Description: The PI, prepared in knowledge of diverse populations in publication of this document in the response to the enactment of the CBCAP order to be effective in preventing and Federal Register. Therefore, a comment program, as set forth in Title II of the treating child abuse and neglect. This PI is best assured of having its full effect Child Abuse Prevention and Treatment contains information collection if OMB receives it within 30 days of Reauthorization Act of 2010 (Public Law requirements that are found in CAPTA publication. 111–320) or CAPTA, provides direction and pursuant to receiving a grant award. to the states and territories to The information submitted will be used ADDRESSES: Written comments and accomplish the purposes of (1) by the agency to ensure compliance recommendations for the proposed supporting community-based efforts to with the statute, complete the information collection should be sent develop, operate, expand, and where calculation of the grant award within 30 days of publication of this appropriate to network, initiatives entitlement, and provide training and notice to www.reginfo.gov/public/do/ aimed at the prevention of child abuse technical assistance to the grantee. PRAMain. Find this particular and neglect, and to support networks of Respondents: State governments, information collection by selecting coordinated resources and activities to quasi-public entities, and non-profit ‘‘Currently under 30-day Review—Open better strengthen and support families to private agencies.

ANNUAL BURDEN ESTIMATES

Annual Annual number Average Total annual Instrument number of of responses burden hours respondents per respondent per response burden hours

Application ...... 52 1 40 2,080 Annual Report ...... 52 1 24 1,248

Estimated Total Annual Burden to expand the information collection to Use Plans. Grantees are required to Hours: 3,328. include the collection of states’ submit their Pre-Expenditure Report no Authority: The CAPTA Reauthorization Intended Use Plans and retitle the less than 30 days prior to the start of the Act of 2010; Title II of the CAPTA, Pub. L. information collection to clarify the role period covered by the report. (2) A Pre- 115–271 (42 U.S.C. 5116 et seq.). of the Pre-Expenditure Report. Expenditure Report that demonstrates DATES: Comments due within 30 days of the state’s anticipated allocation of Mary B.Jones, publication. OMB must make a decision SSBG funding among the 29 pre-defined ACF/OPRE Certifying Officer. about the collection of information SSBG service categories. Historically, [FR Doc. 2021–05411 Filed 3–15–21; 8:45 am] between 30 and 60 days after states have submitted this report using BILLING CODE 4184–01–P publication of this document in the the Post-Expenditure Report Form, and Federal Register. Therefore, a comment the associated burden is included in the is best assured of having its full effect currently approved information DEPARTMENT OF HEALTH AND if OMB receives it within 30 days of collection. Grantees are required to HUMAN SERVICES publication. submit their Intended Use Plan no less than 30 days prior to the start of the Administration for Children and ADDRESSES: Written comments and period covered by the report. (3) A Post- Families recommendations for the proposed information collection should be sent Expenditure Report that details the Submission for OMB Review; Social within 30 days of publication of this state’s actual use of SSBG funding Services Block Grant (SSBG) Post- notice to www.reginfo.gov/public/do/ among each of the 29 service categories. Expenditure Report, Pre-Expenditure PRAMain. Find this particular Grantees are required to submit their Report, and Intended Use Plan (OMB information collection by selecting Post-Expenditure Report within 6 #0970–0234) ‘‘Currently under 30-day Review—Open months of the end of the period covered for Public Comments’’ or by using the by the report. AGENCY: Office of Community Services, search function. Respondents: Agencies that Administration for Children and SUPPLEMENTARY INFORMATION: administer the SSBG at the state or Families, HHS. Description: On an annual basis, territory level, including the 50 states; ACTION: Request for Public Comment. states and territories are required to District of Columbia; Puerto Rico; and submit the following reports: (1) An the territories of American Samoa, SUMMARY: The Administration for Intended Use Plan that provides data Guam, the Virgin Islands, and the Children and Families (ACF) is and narrative descriptions related to the Commonwealth of Northern Mariana requesting a revision to the Social state’s SSBG program. The Intended Use Islands. Services Block Grant (SSBG) Post- Plan includes details about the delivery Annual Burden Estimates: This Expenditure Report, Pre-Expenditure of SSBG services, and the state agency request is specific to the Intended Use Report, and Intended Use Plan (OMB administering the SBG Program. ACF is Plan. Currently approved materials and #0970–0234, previously titled, ‘‘Social proposing to expand the currently associated burden can be found at: Services Block Grant (SSBG) Post- approved information collection to https://www.reginfo.gov/public/do/ Expenditure Report’’). ACF is proposing include collection of states’ Intended PRAViewICR?ref_nbr=202011-0970-006.

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Annual Annual number Average Instrument number of of responses burden hours Total/annual respondents per respondent per response burden hours

Intended Use Plan ...... 56 1 40 2,240.

Estimated Total Annual Burden acceptance receipt is on or before that Submissions,’’ publicly viewable at Hours: 2,240. date. https://www.regulations.gov or at the Dockets Management Staff between 9 Authority: 42 U.S.C. 1397 through 1397e. Electronic Submissions a.m. and 4 p.m., Monday through Mary B. Jones, Submit electronic comments in the Friday, 240–402–7500. ACF/OPRE Certifying Officer. following way: • Confidential Submissions—To • [FR Doc. 2021–05408 Filed 3–15–21; 8:45 am] Federal eRulemaking Portal: submit a comment with confidential BILLING CODE 4184–24–P https://www.regulations.gov. Follow the information that you do not wish to be instructions for submitting comments. made publicly available, submit your Comments submitted electronically, comments only as a written/paper DEPARTMENT OF HEALTH AND including attachments, to https:// submission. You should submit two HUMAN SERVICES www.regulations.gov will be posted to copies total. One copy will include the the docket unchanged. Because your information you claim to be confidential Food and Drug Administration comment will be made public, you are with a heading or cover note that states solely responsible for ensuring that your ‘‘THIS DOCUMENT CONTAINS [Docket No. FDA–2012–N–0547] comment does not include any CONFIDENTIAL INFORMATION.’’ The confidential information that you or a Agency will review this copy, including Agency Information Collection third party may not wish to be posted, the claimed confidential information, in Activities; Proposed Collection; such as medical information, your or its consideration of comments. The Comment Request; Survey on the anyone else’s Social Security number, or second copy, which will have the Occurrence of Foodborne Illness Risk confidential business information, such claimed confidential information Factors in Selected Retail and as a manufacturing process. Please note redacted/blacked out, will be available Foodservice Facility Types that if you include your name, contact for public viewing and posted on AGENCY: Food and Drug Administration, information, or other information that https://www.regulations.gov. Submit HHS. identifies you in the body of your both copies to the Dockets Management comments, that information will be ACTION: Notice. Staff. If you do not wish your name and posted on https://www.regulations.gov. contact information to be made publicly • SUMMARY: The Food and Drug If you want to submit a comment available, you can provide this Administration (FDA or Agency) is with confidential information that you information on the cover sheet and not announcing an opportunity for public do not wish to be made available to the in the body of your comments and you comment on the proposed collection of public, submit the comment as a must identify this information as certain information by the Agency. written/paper submission and in the ‘‘confidential.’’ Any information marked Under the Paperwork Reduction Act of manner detailed (see ‘‘Written/Paper as ‘‘confidential’’ will not be disclosed 1995 (PRA), Federal Agencies are Submissions’’ and ‘‘Instructions’’). except in accordance with 21 CFR 10.20 required to publish notice in the Written/Paper Submissions and other applicable disclosure law. For Federal Register concerning each more information about FDA’s posting proposed collection of information, Submit written/paper submissions as of comments to public dockets, see 80 including each proposed extension of an follows: FR 56469, September 18, 2015, or access • Mail/Hand Delivery/Courier (for existing collection of information, and the information at: https:// written/paper submissions): Dockets to allow 60 days for public comment in www.govinfo.gov/content/pkg/FR-2015- Management Staff (HFA–305), Food and response to the notice. This notice 09-18/pdf/2015-23389.pdf. Drug Administration, 5630 Fishers solicits comments on ‘‘Survey on the Docket: For access to the docket to Lane, Rm. 1061, Rockville, MD 20852. Occurrence of Foodborne Illness Risk read background documents or the • For written/paper comments Factors in Selected Retail and electronic and written/paper comments submitted to the Dockets Management Foodservice Facility Types.’’ received, go to https:// Staff, FDA will post your comment, as DATES: Submit either electronic or www.regulations.gov and insert the well as any attachments, except for docket number, found in brackets in the written comments on the collection of information submitted, marked and information by May 17, 2021. heading of this document, into the identified, as confidential, if submitted ‘‘Search’’ box and follow the prompts ADDRESSES: You may submit comments as detailed in ‘‘Instructions.’’ and/or go to the Dockets Management as follows. Please note that late, Instructions: All submissions received Staff, 5630 Fishers Lane, Rm. 1061, untimely filed comments will not be must include the Docket No. FDA– Rockville, MD 20852, 240–402–7500. considered. Electronic comments must 2012–N–0547 for ‘‘Agency Information be submitted on or before May 17, 2021. Collection Activities; Proposed FOR FURTHER INFORMATION CONTACT: Ila The https://www.regulations.gov Collection; Comment Request; Survey S. Mizrachi, Office of Operations, Food electronic filing system will accept on the Occurrence of Foodborne Illness and Drug Administration, Three White comments until 11:59 p.m. Eastern Time Risk Factors in Selected Retail and Flint North, 10A–12M, 11601 at the end of May 17, 2021. Comments Foodservice Facility Types.’’ Received Landsdown St., North Bethesda, MD received by mail/hand delivery/courier comments, those filed in a timely 20852, 301–796–7726, PRAStaff@ (for written/paper submissions) will be manner (see ADDRESSES), will be placed fda.hhs.gov. considered timely if they are in the docket and, except for those SUPPLEMENTARY INFORMATION: Under the postmarked or the delivery service submitted as ‘‘Confidential PRA (44 U.S.C. 3501–3521), Federal

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Agencies must obtain approval from the assumptions used; (3) ways to enhance • Food from Unsafe Sources, Office of Management and Budget the quality, utility, and clarity of the • Poor Personal Hygiene, (OMB) for each collection of information to be collected; and (4) • Inadequate Cooking, information they conduct or sponsor. ways to minimize the burden of the • Improper Holding/Time and ‘‘Collection of information’’ is defined collection of information on Temperature, and in 44 U.S.C. 3502(3) and 5 CFR respondents, including through the use • Contaminated Equipment/Cross- 1320.3(c) and includes Agency requests of automated collection techniques, Contamination. or requirements that members of the when appropriate, and other forms of public submit reports, keep records, or information technology. FDA developed reports summarizing provide information to a third party. the findings for each of the three data Survey on the Occurrence of Foodborne Section 3506(c)(2)(A) of the PRA (44 collection periods, released in 2000, Illness Risk Factors in Selected Retail U.S.C. 3506(c)(2)(A)) requires Federal 2004, and 2009 (Refs. 1 to 3). Data from and Foodservice Facility Types Agencies to provide a 60-day notice in all three data collection periods were the Federal Register concerning each OMB Control Number 0910–0744— analyzed to detect trends in proposed collection of information, Extension improvement or regression over time including each proposed extension of an and to determine whether progress had I. Background existing collection of information, been made toward the goal of reducing before submitting the collection to OMB From 1998 to 2008, the FDA’s the occurrence of foodborne illness risk for approval. To comply with this National Retail Food Team conducted a factors in selected retail and foodservice requirement, FDA is publishing notice study to measure trends in the facility types (Ref. 4). of the proposed collection of occurrence of foodborne illness risk Using this 10-year survey as a information set forth in this document. factors, preparation practices, and foundation, in 2013–2014, FDA initiated With respect to the following employee behaviors most commonly a new study in full-service and fast-food collection of information, FDA invites reported to the Centers for Disease restaurants. This study will span 10 comments on these topics: (1) Whether Control and Prevention as contributing years with data collections completed in the proposed collection of information factors to foodborne illness outbreaks at 2013–2014 and 2017–2018, and an is necessary for the proper performance the retail level. Specifically, data was additional collection planned for 2021– of FDA’s functions, including whether collected by FDA Specialists in retail 2022. Three data collections are the information will have practical and foodservice establishments at 5-year necessary to trend the data. Data utility; (2) the accuracy of FDA’s intervals (1998, 2003, and 2008) in order collected in 2013–2014 is published, estimate of the burden of the proposed to observe and document trends in the and data from 2017–2018 is currently collection of information, including the occurrence of the following foodborne being evaluated for trends and validity of the methodology and illness risk factors: significance.

TABLE 1—DESCRIPTION OF THE FACILITY TYPES INCLUDED IN THE SURVEY

Facility type Description

Full-Service Restaurants ...... A restaurant where customers place their orders at their tables, are served their meals at the tables, receive the services of the wait staff, and pay at the end of the meals. Fast-Food Restaurants ...... A restaurant that is not a full-service restaurant. This includes restaurants commonly referred to as quick-service restaurants and fast, casual restaurants.

The results of this 10-year study and the Economy Act (31 U.S.C. 1535) follows. To obtain a sufficient number period will be used to: require FDA to provide assistance to of observations to conduct statistically • Develop retail food safety other Federal, State, and local significant analysis, FDA will conduct initiatives, policies, and targeted government bodies. approximately 400 data collections in intervention strategies focused on The objectives of this study are to: each facility type. This sample size has controlling foodborne illness risk • Identify the least and most often been calculated to provide for sufficient factors; occurring foodborne illness risk factors observations to be 95 percent confident • Provide technical assistance to and food safety behaviors/practices in that the compliance percentage is State, local, tribal, and territorial restaurants within the United States; within 5 percent of the true compliance regulatory professionals; • Determine the extent to which Food percentage. • Identify FDA retail work plan Safety Management Systems and the A geographical information system priorities; and presence of a Certified Food Protection database containing a listing of • Inform FDA resource allocation to Manager impact the occurrence of businesses throughout the United States enhance retail food safety nationwide. foodborne illness risk factors and food provides the establishment inventory for The statutory basis for FDA safety behaviors/practices; and the data collections. FDA samples conducting this study is derived from • Determine whether the occurrence establishments from the inventory based the Public Health Service Act (PHS Act) of foodborne illness risk factors food on the descriptions in table 1. FDA does (42 U.S.C. 243, section 311(a)). safety behaviors/practices in delis not intend to sample operations that Responsibility for carrying out the differs based on an establishment’s risk handle only prepackaged food items or provisions of the PHS Act relative to categorization and status as a single-unit conduct low-risk food preparation food protection was transferred to the or multiple-unit operation (e.g., activities. The ‘‘FDA Food Code’’ Commissioner of Food and Drugs in restaurants that are part of an operation contains a grouping of establishments 1968 (21 CFR 5.10(a)(2) and (4)). with two or more units). by risk, based on the type of food Additionally, the Federal Food, Drug, The methodology to be used for this preparation that is normally conducted and Cosmetic Act (21 U.S.C. 301 et seq.) information collection is described as within the operation (Ref. 5). The intent

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is to sample establishments that fall collection, and a substitute employees per shift, is also collected. under risk categories 2 through 4. establishment will be used. An Data will be consolidated and reported FDA has approximately 25 Retail invitation is extended to the State or in a manner that does not reveal the Food Specialists (Specialists) who serve local regulatory authority to accompany identity of any establishment included as the data collectors for the 10-year the Specialist on the data collection in the study. study. The Specialists are visit. FDA has collaborated with the Food geographically dispersed throughout the A standard form is used by the Protection and Defense Institute to United States and possess technical Specialists during each data collection. develop a web-based platform in expertise in retail food safety and a solid The form is divided into three sections: FoodSHIELD to collect, store, and understanding of the operations within Section 1—‘‘Establishment analyze data for the Retail Risk Factor each of the facility types to be surveyed. Information’’; Section 2—‘‘Regulatory Study. This platform is accessible to The Specialists are also standardized by Authority Information’’; and Section 3— State, local, territorial, and tribal FDA’s Center for Food Safety and ‘‘Foodborne Illness Risk Factor and regulatory jurisdictions to collect data Applied Nutrition personnel in the Food Safety Management System relevant to their own risk factor studies. application and interpretation of the Assessment.’’ The information in For the 2015–2016 data collection, FDA FDA Food Code (Ref. 5). Section 1 ‘‘Establishment Information’’ piloted the use of hand-held technology Sampling zones have been established of the form is obtained during an for capturing the data onsite during the that are equal to the 175-mile radius interview with the establishment owner data collection visits. The tablets that around a Specialist’s home location. or person in charge by the Specialist were made available for the data The sample is selected randomly from and includes a standard set of questions. collections were part of a broader among all eligible establishments The information in Section 2 Agency initiative focused on internal located within these sampling zones. ‘‘Regulatory Authority Information’’ is uses of hand-held technology. The The Specialists are generally located in obtained during an interview with the tablets provided for the data collection major areas (i.e., program director of the State or local presented several technical and population centers) across the jurisdiction that has regulatory logistical challenges and increased the contiguous United States. Population responsibility for conducting time burden associated with the data centers usually contain a large inspections for the selected collection as compared to the manual concentration of the establishments establishment. entry of data collections. For these FDA intends to sample. Sampling from Section 3 includes three parts: Part A reasons, FDA will not be further the 175-mile radius sampling zones for tabulating the Specialists’ evaluating hand-held technology in around the Specialists’ home locations observations of the food employees’ subsequent data collections during the provides three advantages to the study: behaviors and practices in limiting 10-year study period. 1. It provides a cross-section of urban contamination, proliferation, and When a data collector is assigned a and rural areas from which to sample survival of food safety hazards; Part B specific establishment, he or she the eligible establishments. for assessing the food safety conducts the data collection and enters 2. It represents a mix of small, management system being implemented the information into the web-based data medium, and large regulatory entities by the facility; and Part C for assessing platform. The interface will support the having jurisdiction over the eligible the frequency and extent of food manual entering of data, as well as the establishments. employee handwashing. The ability to directly enter information in 3. It reduces overnight travel and, information in Part A is collected from the database via a web browser. therefore, reduces travel costs incurred the Specialists’ direct observations of The burden for the 2021–2022 data by the Agency to collect data. food employee behaviors and practices. collection is as follows. For each data The sample for each data collection Infrequent, nonstandard questions may collection, the respondents will include: period is evenly distributed among be asked by the Specialists if (1) The person in charge of the selected Specialists. Given that participation in clarification is needed on the food safety facility (whether it be a fast-food or full- the study by industry is voluntary and procedure or practice being observed. service restaurant); and (2) the program the status of any given randomly The information in Part B is collected by director (or designated individual) of selected establishment is subject to making direct observations and asking the respective regulatory authority. In change, substitute establishments have follow-up questions of facility order to provide the sufficient number been selected for each Specialist for management to obtain information on of observations needed to conduct a cases where the restaurant facility is the extent to which the food statistically significant analysis of the misclassified, closed, or otherwise establishment has developed and data, FDA has determined that 400 data unavailable, unable, or unwilling to implemented food safety management collections will be required in each of participate. systems. The information in Part C is the two restaurant facility types. Prior to conducting the data collected by making direct observations Therefore, the total number of responses collection, Specialists contact the State of food employee handwashing. No will be 1,600 (400 data collections × 2 or local jurisdiction that has regulatory questions are asked in the completion of facility types × 2 respondents per data responsibility for conducting retail food Section 3, Part C of the form. collection). inspections for the selected FDA collects the following The burden associated with the establishment. The Specialist verifies information associated with the completion of Sections 1 and 3 of the with the jurisdiction that the facility has establishment’s identity: Establishment form is specific to the persons in charge been properly classified for the name, street address, city, State, ZIP of the selected facilities. The burden purposes of the study and is still in Code, county, industry segment, and includes the time it will take the person operation. The Specialist ascertains facility type. The establishment- in charge to accompany the data whether the selected facility is under identifying information is collected to collector during the site visit and legal notice from the State or local ensure the data collections are not answer the data collector’s questions. regulatory authority. If the selected duplicative. Other information related The burden related to the completion of facility is under legal notice, the to the nature of the operation, such as Section 2 of the form is specific to the Specialist will not conduct a data seating capacity and number of program directors (or designated

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individuals) of the respective regulatory collection, the burden estimate was 106 estimate for a data collection in a fast- authorities. The burden includes the minutes (1.76 hours) in full-service food restaurant, including both the time it will take to answer the data restaurants and 73 minutes (1.21 hours) program director’s and the person in collectors’ questions and is the same in fast-food restaurants. FDA estimates charge’s responses, is 112 minutes (82 + regardless of the facility type. that it will take the program director (or 30) (1.86 hours). To calculate the estimate of the hours designated individual) of the respective Based on the number of entry refusals per response, FDA will use the average regulatory authority 30 minutes (0.5 from the 2017–2018 data collection, we data collection duration for the same hours) to answer the questions related to facility types during the 2015–2016 data estimate a refusal rate of 2 percent for Section 2 of the form. This burden collection. FDA estimates that it will the data collections within restaurant estimate is unchanged from the last data take the persons in charge of full-service facility types. The estimate of the time restaurants and fast-food restaurants 104 collection. Hence, the total burden per non-respondent is 5 minutes (0.08 minutes (1.73 hours) and 82 minutes estimate for a data collection in a full- hours) for the person in charge to listen (1.36 hours), respectively, to accompany service restaurant, including both the to the purpose of the visit and provide the data collectors while they complete program director’s and the person in a verbal refusal of entry. Sections 1 and 3 of the form. In charge’s responses, is 134 minutes (104 FDA estimates the burden of this comparison, for the 2017–2018 data + 30) (2.23 hours). The total burden collection of information as follows: TABLE 2—ESTIMATED ANNUAL REPORTING BURDEN 1

Number of Number of Activity Number of responses per Total annual Number of responses per Total annual Average burden per Total respondents respondent responses non-respondents non-respondent non-responses response hours

2021–2022 Data Collection (Fast Food Res- 400 1 400 ...... 1.36 ...... 544 taurants)—Completion of Sections 1 and 3. 2021–2022 Data Collection (Full-Service Res- 400 1 400 ...... 1.73 ...... 692 taurants)—Completion of Sections 1 and 3. 2021–2022 Data Collection—Completion of Sec- 800 1 800 ...... 0.5 (30 minutes) ..... 400 tion 2—All Facility Types. 2021–2022 Data Collection—Entry Refusals—All ...... 16 1 16 0.08 (5 minutes) ..... 1.28 Facility Types.

Total Hours ...... 1,637.28 1 There are no capital costs or operating and maintenance costs associated with this collection of information.

Based on a review of the information Facility Types (2009).’’ Available at DEPARTMENT OF HEALTH AND collection since our last request for https://wayback.archive-it.org/7993/ HUMAN SERVICES OMB approval, we have made no 20170406023004/https://www.fda.gov/ adjustments to our burden estimate. Food/GuidanceRegulation/ Food and Drug Administration RetailFoodProtection/FoodborneIllness [Docket No. FDA–2018–N–1857] II. References RiskFactorReduction/ucm224321.htm The following references are on 4. FDA National Retail Food Team, ‘‘FDA Agency Information Collection display in the Dockets Management Trend Analysis Report on the Activities; Proposed Collection; Staff (see ADDRESSES) and are available Occurrence of Foodborne Illness Risk Comment Request; Current Good for viewing by interested persons Factors in Selected Institutional Manufacturing Practice, Hazard between 9 a.m. and 4 p.m., Monday Foodservice, Restaurant, and Retail Food Analysis, and Risk-Based Preventive through Friday; they are also available Store Facility Types (1998–2008).’’ Controls for Human Food, and Current (2010). Available at https:// electronically at https:// Good Manufacturing Practice, Hazard wayback.archive-it.org/7993/ www.regulations.gov. FDA has verified Analysis, and Risk-Based Preventive 20170406022950/https://www.fda.gov/ the website addresses, as of the date this Controls for Animal Food document publishes in the Federal Food/GuidanceRegulation/ Register, but websites are subject to RetailFoodProtection/FoodborneIllness AGENCY: Food and Drug Administration, change over time. RiskFactorReduction/ucm223293.htm HHS. 5. FDA, ‘‘FDA Food Code.’’ Available at 1. FDA, ‘‘Report of the FDA Retail Food ACTION: Notice. https://www.fda.gov/FoodCode. Program Database of Foodborne Illness Risk Factors (2000).’’ Available at Dated: March 9, 2021. SUMMARY: The Food and Drug https://wayback.archive-it.org/7993/ Lauren K. Roth, Administration (FDA or Agency) is 20170406023019/https://www.fda.gov/ announcing an opportunity for public downloads/Food/GuidanceRegulation/ Acting Principal Associate Commissioner for comment on the proposed collection of Policy. UCM123546.pdf certain information by the Agency. 2. FDA, ‘‘FDA Report on the Occurrence of [FR Doc. 2021–05325 Filed 3–15–21; 8:45 am] Under the Paperwork Reduction Act of Foodborne Illness Risk Factors in BILLING CODE 4164–01–P Selected Institutional Foodservice, 1995 (PRA), Federal Agencies are Restaurant, and Retail Food Store required to publish notice in the Facility Types (2004).’’ Available at Federal Register concerning each https://wayback.archive-it.org/7993/ proposed collection of information, 20170406023011/https://www.fda.gov/ including each proposed extension of an downloads/Food/GuidanceRegulation/ existing collection of information, and RetailFoodProtection/FoodborneIllness to allow 60 days for public comment in RiskFactorReduction/UCM423850.pdf 3. FDA, ‘‘FDA Report on the Occurrence of response to the notice. This notice Foodborne Illness Risk Factors in solicits comments on the information Selected Institutional Foodservice, collection requirements associated with Restaurant, and Retail Food Store current good manufacturing practice,

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hazard analysis, and risk-based Instructions: All submissions received FOR FURTHER INFORMATION CONTACT: preventive controls for human and must include the Docket No. FDA– Domini Bean, Office of Operations, animal food. 2018–N–1857 for ‘‘Agency Information Food and Drug Administration, Three DATES: Submit either electronic or Collection Activities; Proposed White Flint North, 10A–12M, 11601 written comments on the collection of Collection; Comment Request; Current Landsdown St., North Bethesda, MD information by May 17, 2021. Good Manufacturing Practice, Hazard 20852, 301–796–5733, PRAStaff@ ADDRESSES: You may submit comments Analysis, and Risk-Based Preventive fda.hhs.gov. as follows. Please note that late, Controls for Human Food, and Current SUPPLEMENTARY INFORMATION: Under the untimely filed comments will not be Good Manufacturing Practice, Hazard PRA (44 U.S.C. 3501–3521), Federal considered. Electronic comments must Analysis, and Risk-Based Preventive Agencies must obtain approval from the be submitted on or before May 17, 2021. Controls for Animal Food.’’ Received Office of Management and Budget The https://www.regulations.gov comments, those filed in a timely (OMB) for each collection of electronic filing system will accept manner (see ADDRESSES), will be placed information they conduct or sponsor. comments until 11:59 p.m. Eastern Time in the docket and, except for those ‘‘Collection of information’’ is defined at the end of May 17, 2021. Comments submitted as ‘‘Confidential in 44 U.S.C. 3502(3) and 5 CFR received by mail/hand delivery/courier Submissions,’’ publicly viewable at 1320.3(c) and includes Agency requests (for written/paper submissions) will be https://www.regulations.gov or at the or requirements that members of the considered timely if they are Dockets Management Staff between 9 public submit reports, keep records, or postmarked or the delivery service a.m. and 4 p.m., Monday through provide information to a third party. acceptance receipt is on or before that Friday, 240–402–7500. Section 3506(c)(2)(A) of the PRA (44 date. • Confidential Submissions—To U.S.C. 3506(c)(2)(A)) requires Federal Electronic Submissions submit a comment with confidential Agencies to provide a 60-day notice in the Federal Register concerning each Submit electronic comments in the information that you do not wish to be made publicly available, submit your proposed collection of information, following way: including each proposed extension of an • comments only as a written/paper Federal eRulemaking Portal: existing collection of information, submission. You should submit two https://www.regulations.gov. Follow the before submitting the collection to OMB copies total. One copy will include the instructions for submitting comments. for approval. To comply with this information you claim to be confidential Comments submitted electronically, requirement, FDA is publishing notice with a heading or cover note that states including attachments, to https:// of the proposed collection of www.regulations.gov will be posted to ‘‘THIS DOCUMENT CONTAINS information set forth in this document. the docket unchanged. Because your CONFIDENTIAL INFORMATION.’’ The With respect to the following comment will be made public, you are Agency will review this copy, including collection of information, FDA invites solely responsible for ensuring that your the claimed confidential information, in comments on these topics: (1) Whether comment does not include any its consideration of comments. The the proposed collection of information confidential information that you or a second copy, which will have the is necessary for the proper performance third party may not wish to be posted, claimed confidential information of FDA’s functions, including whether such as medical information, your or redacted/blacked out, will be available the information will have practical anyone else’s Social Security number, or for public viewing and posted on utility; (2) the accuracy of FDA’s confidential business information, such https://www.regulations.gov. Submit estimate of the burden of the proposed as a manufacturing process. Please note both copies to the Dockets Management collection of information, including the that if you include your name, contact Staff. If you do not wish your name and validity of the methodology and information, or other information that contact information to be made publicly assumptions used; (3) ways to enhance identifies you in the body of your available, you can provide this the quality, utility, and clarity of the comments, that information will be information on the cover sheet and not information to be collected; and (4) posted on https://www.regulations.gov. in the body of your comments and you • ways to minimize the burden of the If you want to submit a comment must identify this information as collection of information on with confidential information that you ‘‘confidential.’’ Any information marked respondents, including through the use do not wish to be made available to the as ‘‘confidential’’ will not be disclosed of automated collection techniques, public, submit the comment as a except in accordance with 21 CFR 10.20 when appropriate, and other forms of written/paper submission and in the and other applicable disclosure law. For information technology. manner detailed (see ‘‘Written/Paper more information about FDA’s posting Submissions’’ and ‘‘Instructions’’). of comments to public dockets, see 80 Current Good Manufacturing Practice and Hazard Analysis, and Risk-Based Written/Paper Submissions FR 56469, September 18, 2015, or access the information at: https:// Preventive Controls for Human Food— Submit written/paper submissions as www.govinfo.gov/content/pkg/FR-2015- 21 CFR Part 117; Current Good follows: Manufacturing Practice and Hazard 09-18/pdf/2015-23389.pdf. • Mail/Hand Delivery/Courier (for Analysis, and Risk-Based Preventive written/paper submissions): Dockets Docket: For access to the docket to Controls for Animal Food—21 CFR Part Management Staff (HFA–305), Food and read background documents or the 507 Drug Administration, 5630 Fishers electronic and written/paper comments Lane, Rm. 1061, Rockville, MD 20852. received, go to https:// OMB Control Number 0910–0751— • For written/paper comments www.regulations.gov and insert the Revision submitted to the Dockets Management docket number, found in brackets in the This information collection supports Staff, FDA will post your comment, as heading of this document, into the FDA regulations setting forth criteria well as any attachments, except for ‘‘Search’’ box and follow the prompts and definitions applicable to human information submitted, marked and and/or go to the Dockets Management food and to animal food, as established identified, as confidential, if submitted Staff, 5630 Fishers Lane, Rm. 1061, under the FDA Food Safety and as detailed in ‘‘Instructions.’’ Rockville, MD 20852, 240–402–7500. Modernization Act (FSMA) (Pub. L.

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111–353). Congress enacted FSMA in while regulations governing animal food us to issue guidance on documentation response to dramatic changes in the are found in part 507 (21 CFR part 507). required to determine status as a global food system and in our Respondents to the information qualified facility. Accordingly, we understanding of foodborne illness and collection are those who manufacture, issued a guidance for industry entitled its consequences, including the prepare, pack, or hold food intended for ‘‘Determination of Status as a Qualified realization that preventable foodborne humans or animals. Facility Under Part 117: Current Good illness is both a significant public health The regulations include Manufacturing Practice, Hazard problem and a threat to the economic recordkeeping necessary to demonstrate Analysis, and Risk-Based Preventive well-being of the food system. The compliance with the requirements; Controls for Human Food and Part 507: purpose of the regulations is to prevent however, respondents that meet the Current Good Manufacturing Practice, the introduction of adulterated and/or definition of a ‘‘qualified facility,’’ Hazard Analysis, and Risk-Based misbranded products into the under 21 CFR 117.3 and 507.3, are Preventive Controls for Food for marketplace and ensure the safety of subject to reporting. To be subject to the Animals,’’ also available for both human foods and animal foods in modified requirements set forth in part downloading from our website at: accordance with sections 402 and 403 of 117, subpart D and part 507, subpart D https://www.fda.gov/regulatory- the Federal Food, Drug, and Cosmetic for human food and animal food, information/search-fda-guidance- Act (FD&C Act) (21 U.S.C. 342 and 343). respectively, respondents must attest to documents/guidance-industry- Generally, domestic and foreign food their status. To assist respondents in determination-status-qualified-facility. facilities that are required to register in this regard, we have developed Forms The guidance discusses the content, accordance with section 415 of the FDA 3942a (Quality Facility Attestation: format, frequency, and timing of FD&C Act (21 U.S.C. 350d) must comply Human Food) and 3942b (Quality submissions. For efficiency of Agency with these requirements, unless an Facility Attestation: Animal Food), operations, we are now accounting for exemption applies. It is important to available for downloading from our burden we attribute to reporting note, however, that applicability of the website at: https://www.fda.gov/food/ associated with Forms FDA 3942a and current good manufacturing practice registration-food-facilities-and-other- 3942b, currently approved under OMB requirements is not dependent upon submissions/qualified-facility- control number 0910–0854, with this whether a facility is required to register. attestation. information collection. Regulations governing human food are Section 418(l)(2)(B)(ii) of the FD&C We estimate the burden of this set forth in part 117 (21 CFR part 117), Act (21 U.S.C. 350g(l)(2)(B)(ii)) directs collection of information as follows:

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

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

117.201(c); qualified facility as reported on 37,134 2 0.5 18,567 0.5 (30 minutes) ...... 9,284 Form FDA 3942a. 507.7(c); qualified facility as reported on Form 1,120 0.5 560 0.5 (30 minutes) ...... 280 FDA 3942b.

Total ...... 9,564 1 There are no capital costs or operating and maintenance costs associated with this collection of information. 2 Reporting occurs biennially.

TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN: HUMAN FOODS 1

Number of 21 CFR section; activity Number of records per Total annual Average burden per Total hours recordkeepers recordkeeper records recordkeeping

117.126(c) and 117.170(d); food safety plan and 46,685 1 46,685 110...... 5,135,350 reanalysis. 117.136; assurance records ...... 16,285 1 16,285 0.25 (15 minutes) ...... 4,071 117.145(c); monitoring records ...... 8,143 730 5,944,390 0.05 (3 minutes) ...... 297,220 117.150(d); corrective actions and corrections 16,285 2 32,570 1...... 32,570 records. 117.155(b); verification records ...... 8,143 244 1,986,892 0.05 (3 minutes) ...... 99,345 117.160; validation records ...... 3,677 6 22,062 0.25 (15 minutes) ...... 5,515 117.475(c)(7)–(9); supplier records ...... 16,285 10 162,850 4 ...... 651,400 117.180(d); training records for preventive con- 46,685 1 46,685 0.25 (15 minutes) ...... 11,671 trols qualified individual.

Total ...... 6,237,142 1 There are no capital costs or operating and maintenance costs associated with this collection of information.

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TABLE 3—ESTIMATED ANNUAL RECORDKEEPING BURDEN: ANIMAL FOODS 1

Number of Number of Total annual Average burden per 21 CFR section; activity records per Total hours 2 recordkeepers recordkeeper records recordkeeping

Subpart A—General Provisions

507.4(d); documentation of animal food safety 7,469 0.75 5,579 0.05 (3 minutes) ...... 279 and hygiene training.

Subpart C—Hazard Analysis and Risk-Based Preventive Controls

507.31 through 507.55; food safety plan—includ- 7,469 519 3,876,411 0.1 (6 minutes) ...... 387,641 ing hazard analysis, preventive controls, and procedures for monitoring, corrective actions, verification, recall plan, validation, reanalysis, modifications, and implementation records.

Subpart E—Supply Chain Program

507.105 through 507.175; written supply-chain 7,469 519 3,876,411 0.1 (6 minutes) ...... 387,641 program—including records documenting pro- gram.

Subpart F—Requirements Applying to Records That Must Be Established and Maintained

507.200 through 507.215; general requirements, 7,469 519 3,876,411 0.1 (6 minutes) ...... 387,641 additional requirements applying to food safety plan, requirements for record retention, use of existing records, and special requirements ap- plicable to written assurance.

Total ...... 11,635,372 ...... 1,163,258 1 There are no capital costs or operating and maintenance costs associated with this collection of information. 2 Total hours have been rounded.

TABLE 4—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN: HUMAN FOODS 1

Number of 21 CFR section; activity Number of disclosures per Total annual Average burden per Total hours respondents respondent disclosures disclosure

117.201(e); disclosure of food manufacturing fa- 37,134 1 37,134 0.25 (15 minutes) ...... 9,284 cility address. 1 There are no capital costs or operating and maintenance costs associated with this collection of information.

TABLE 5—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1

Number of 21 CFR section; activity Number of disclosures per Total annual Average burden per Total hours respondents respondent disclosures disclosure

507.27(b); labeling for the animal food product 330 10 3,300 0.25 (15 minutes) ...... 825 contains the specific information and instruc- tions needed so the food can be safely used for the intended animal species. 507.7(e)(1); change labels on products with la- 1,120 4 4,480 1...... 4,480 bels. 507.7(e)(2); change address on labeling (sales 974 1 974 1...... 974 documents) for qualified facilities. 507.25(a)(2); animal food, including raw mate- 373 312 116,376 0.01 (36 seconds) ...... 1,163.76 rials, other ingredients, and rework, is accu- rately identified. 507.28(b); holding and distribution of human 40,798 2 81,596 0.25 (15 minutes) ...... 20,399 food byproducts for use as animal food.

Total ...... 27,841.76 1 There are no capital costs or operating and maintenance costs associated with this collection of information.

Based on a review of the information adjustments to reflect a decrease in we provide a cumulative estimate for collection since our last request for third-party disclosure burden associated related disclosure activities that we had OMB approval, we have made slight with animal foods. In this submission previously accounted for separately.

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Dated: March 9, 2021. Empirical Study of Promotional cder/ucm090276.htm. The website Lauren K. Roth, Implications of Proprietary includes links to the latest Federal Acting Principal Associate Commissioner for Prescription Drug Names Register notices and peer-reviewed publications produced by our office. Policy. OMB Control Number 0910–NEW [FR Doc. 2021–05332 Filed 3–15–21; 8:45 am] The website maintains information on Section 1701(a)(4) of the Public BILLING CODE 4164–01–P studies we have conducted, dating back Health Service Act (42 U.S.C. to a survey on direct-to-consumer 300u(a)(4)) authorizes FDA to conduct advertisements conducted in 1999. DEPARTMENT OF HEALTH AND research relating to health information. During the prescription drug approval HUMAN SERVICES Section 1003(d)(2)(C) of the Federal process, sponsors propose proprietary Food, Drug, and Cosmetic Act (FD&C names for their products. These names Food and Drug Administration Act) (21 U.S.C. 393(d)(2)(C)) authorizes undergo a proprietary name review that FDA to conduct research relating to involves the Office of Drug Safety, the drugs and other FDA regulated products [Docket No. FDA–2019–N–5666] relevant medical office, and OPDP. in carrying out the provisions of the OPDP reviews names to assess for Agency Information Collection FD&C Act. alignment with the FD&C Act, which, Activities; Submission for Office of The Office of Prescription Drug among other things, provides that Management and Budget Review; Promotion’s (OPDP) mission is to labeling can misbrand a product if false Comment Request; Empirical Study of protect the public health by helping to or misleading representations are made Promotional Implications of ensure that prescription drug promotion (see 21 U.S.C. 321(n), 352(a)). A Proprietary Prescription Drug Names is truthful, balanced, and accurately proprietary name, which appears in communicated. OPDP’s research labeling, could result in such AGENCY: Food and Drug Administration, program provides scientific evidence to misbranding if it is false or misleading. HHS. help ensure that our policies related to OPDP focuses its review on identifying prescription drug promotion will have names that overstate the efficacy or ACTION: Notice. the greatest benefit to public health. safety of the drug, suggest drug Toward that end, we have consistently indications that are not accurate, suggest SUMMARY: The Food and Drug conducted research to evaluate the superiority without substantiation, or Administration (FDA) is announcing aspects of prescription drug promotion are of a fanciful nature that misleadingly that a proposed collection of that are most central to our mission. Our implies unique effectiveness or information has been submitted to the research focuses in particular on three composition. This research will focus Office of Management and Budget main topic areas: (1) Advertising on the effect on consumers’ and/or (OMB) for review and clearance under features, including content and format; healthcare providers’ perceptions of a the Paperwork Reduction Act of 1995 (2) target populations; and (3) research drug product of names that overstate the (PRA). quality. Through the evaluation of efficacy of the drug product. An advertising features we assess how overstatement of efficacy can occur, for DATES: Submit written comments elements such as graphics, format, and example, in terms of level of efficacy, in (including recommendations) on the disease and product characteristics which the degree of relief is overstated, collection of information by April 15, impact the communication and or in terms of the type of effect, in 2021. understanding of prescription drug risks which case there is a mismatch with the and benefits; focusing on target indication of the drug. The drug ADDRESSES: To ensure that comments on populations allows us to evaluate how the information collection are received, products that are studied will be understanding of prescription drug risks fictitious, and whether the names OMB recommends that written and benefits may vary as a function of comments be submitted to https:// overstate the drug products’ efficacy audience; and our focus on research will be determined with regard to the www.reginfo.gov/public/do/PRAMain. quality aims at maximizing the quality products’ fictitious degree of efficacy. Find this particular information of our research data through analytical collection by selecting ‘‘Currently under The proposed study is designed to methodology development and provide systematic, empirical evidence Review—Open for Public Comments’’ or investigation of sampling and response by using the search function. The title to answer two research questions: issues. This study will inform the first • Primary research question: How, if of this information collection is two topic areas, advertising features and ‘‘Empirical Study of Promotional at all, do names that suggest the medical target populations. condition for which a drug is indicated Implications of Proprietary Prescription Because we recognize that the Drug Names.’’ Also include the FDA affect consumers’ and/or healthcare strength of data and the confidence in providers’ perceptions of prescription docket number found in brackets in the the robust nature of the findings is heading of this document. drugs? improved by utilizing the results of • Secondary research question: How, FOR FURTHER INFORMATION CONTACT: Ila multiple converging studies, we if at all, do names that suggest an S. Mizrachi, Office of Operations, Food continue to develop evidence to inform overstatement of the degree of efficacy and Drug Administration, Three White our thinking. We evaluate the results of the drug affect consumers’ and/or Flint North, 10A–12M, 11601 from our studies within the broader healthcare providers’ perceptions of Landsdown St., North Bethesda, MD context of research and findings from prescription drugs? 20852, 301–796–7726, PRAStaff@ other sources, and this larger body of The ideas generated in the fda.hhs.gov. knowledge collectively informs our Prescription Drug User Fee policies as well as our research program. Amendments pilot project proprietary SUPPLEMENTARY INFORMATION: In Our research is documented on our name review concept paper of 2008 1 compliance with 44 U.S.C. 3507, FDA homepage, which can be found at: provided a starting point for the study. has submitted the following proposed https://www.fda.gov/aboutfda/ collection of information to OMB for centersoffices/ 1 https://www.regulations.gov/docket?D=FDA- review and clearance. officeofmedicalproductsandtobacco/ 2008-N-0281.

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Based on ideas from that document, a (Response 1) We agree and currently ranking of most obvious benefit. Names review of the linguistics and social have those exclusions included in the with the lowest joint rank across the sciences literature, and an screener. four measures were considered most environmental scan of existing (Comment 2) Two comments extreme and those with highest were proprietary names, FDA developed and recommended the screener should considered most neutral. The results pretested an extreme, explicitly include additional inclusion/exclusion were consistent between HCPs and suggestive name (e.g., CuresFlux) and a criteria, such as number of years in consumers. neutral name (e.g., Zerpexin) for two practice and in what size facility they (Comment 5) One comment medical conditions, high cholesterol work (HCPs), and whether consumers recommended excluding ‘‘extreme, and gastroesophageal reflux disease have any of five diagnoses and how explicitly suggestive’’ proprietary names (GERD) (pretesting approved under many HCPs they see (consumers). that FDA would never permit or names OMB control number 0910–0695). In the (Response 2) We plan to include most that suggest the drug indication. The proposed main study, approximately of the screening criteria and comment suggested instead that FDA 500 consumers from the general demographic data mentioned, including use data that could assist the Agency in population and 500 healthcare years in practice (HCPs); amount of time determining impressions produced by providers (including physicians, nurse treating patients (HCPs); size of facility permissible proprietary names and practitioners, and physician assistants) (HCPs); age (consumers); and diagnosis names that would marginally fail FDA’s will see these pretested extreme and with one of the two illnesses which the misbranding review. neutral names plus five target names per hypothetical drugs in this study are (Response 5) The purpose of indication (names that may suggest the indicated to treat—GERD and high including ‘‘extreme’’ names in this medical condition and vary in terms of cholesterol (consumers). Some of the study is not to have data on names that promise of effect) and answer questions other suggested questions for the do not mimic real-world conditions, but about the names, before and after they screener are beyond the scope of this to have something against which to have been told what each drug’s study. For this study, we have chosen to compare the target names, which are indication is. Target names will vary focus on primary care providers, as similar to the kind of names that would such that some efficacy implications are drugs for these two specific medical be submitted to FDA for approval. Our more apparent than others, and some conditions are prescribed by primary findings may suggest that ‘‘extreme’’ will more clearly imply the medical care providers and should thus be and target names are very different and condition for which a drug is indicated salient for them. Additionally, we will that target names are similar to more than others. Dependent variables will ask relevant background questions of all neutral names in their effects on include identification of the medical participants, both HCPs and consumers, perceptions. condition for which a drug is indicated, to determine age, sex, and race, as well (Comment 6) One comment inquired efficacy, and perceptions. as familiarity with the target conditions. if FDA will be providing sound files (Comment 3) One comment with the intended pronunciation of each To our knowledge, this study is the recommended that the complexity of the of the test names. first to provide a systemic investigation target names should be equivalent (Response 6) In consideration of this of a variety of proprietary prescription across indications. comment, and after hearing from our drug names. (Response 3) We have attempted to cognitive interview participants, we will In the Federal Register of January 21, make these as similar as possible, introduce sound files at the beginning of 2020 (85 FR 3392), FDA published a 60- including having them reviewed by a the survey. day notice requesting public comment linguist and checking the number of (Comment 7) One comment expressed on the proposed collection of syllables across conditions. concerns about how the selection of information. FDA received seven (Comment 4) Three comments target names will represent the current submissions that were PRA-related. One recommend better clarity around what landscape—that is, it questioned how submission was outside the scope of the the definitions of ‘‘typical’’ and FDA will generalize these study results research and is not addressed further. ‘‘standard’’ and ‘‘extreme’’ and across therapeutic areas not tested if Within the remaining six submissions, ‘‘neutral’’ mean when describing the only representing one or two FDA received multiple comments that fictitious drug name and how these therapeutic areas. the Agency has addressed below. For categories were identified and validated. (Response 7) We recognize that our brevity, some public comments are (Response 4) The list of names was study is making use of only two paraphrased and therefore may not developed by our multimedia and therapeutic areas. As one research include the exact language used by the creative services team who are well- study, it cannot examine all possible commenter. We assure commenters that versed in the practice of proprietary therapeutic areas. Although our two the entirety of their comments was name development. The list was divergent medical conditions will not considered even if not fully captured by reviewed by the study team and also by provide us with unlimited information, our paraphrasing in this document. The a consultant with a Ph.D. in linguistics, they will provide limited following acronyms are used here: HCP who helped to screen for any overlap generalizability and provide important = healthcare provider; FDA and Agency between categories. information that may help inform the = Food and Drug Administration; OPDP In July 2019, we conducted a pretest proprietary name review process. = FDA’s Office of Prescription Drug of 120 healthcare providers and 121 (Comment 8) Two comments were Promotion. consumers to establish the categories for concerned that the questionnaire would (Comment 1) Two comments these names. We combined results of take longer than the estimated 20 recommended that the study should four measures to determine the most minutes. exclude consumers who work in the extreme and most neutral amongst a list (Response 8) See our response to healthcare, marketing, or branding of names. These measures included Comment 4 concerning the pretest that industries; primary care providers that ability to identify the medical condition we conducted in July 2019. In the spend less than 50 percent of their time for which the drug is indicated; pretest, we successfully tested a total of on patient care; and the Department of perceived benefit and perceived balance 16 names across two indications in this Health and Human Services employees. of benefit and risk; and, finally, a time frame. During cognitive testing, we

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examined burden and decided to (Response 12) We have described the impressions of safety, efficacy and eliminate Q[uestion]7, which will speed purpose of the study, the design, the indication. response. We will also conduct a soft population of interest, and have (Response 15) We have accomplished launch of the survey with provided the questionnaire to numerous the goals recommended in this comment approximately 10 percent of the sample individuals upon request. Our full by conducting cognitive interviewing. and can look at actual length at that stimuli are under development during During these cognitive interviews, time. This gives us the ability to pause the PRA process. We do not make draft participants were encouraged to think fielding of the survey and make further stimuli public during this time because aloud as they reviewed and answered cuts if the soft launch data suggest it is of concerns that this may contaminate the survey with prompts from a trained necessary. our participant pool and compromise moderator. These interviews enabled us (Comment 9) Five comments the research. We strive to publish the to capture deeper, more qualitative recommended that we add ‘‘none of the results of our research in peer-reviewed responses from a small above,’’ ‘‘no impression,’’ ‘‘no opinion’’ journals and all stimuli will be available nonrepresentative sample of individuals or ‘‘do not know’’ response options to at that time. in order to improve the questionnaire. some questions. (Comment 13) One comment (Comment 16) One comment (Response 9) The rationale usually recommended a specific approach for suggested FDA consider the inverse given for including ‘‘don’t know’’/‘‘no addressing the issue of broadening the approach of our design by setting up the opinion’’/‘‘none’’ options is to allow indication that included an unaided ‘‘fit research to examine how, if at all, participants who cannot form a relevant to category’’ question and an open- names that do suggest the drug’s judgment (e.g., due to insufficient ended ‘‘does the brand name tell you indication increase the chance for information) a way to indicate as much. anything about the product?’’ OR ‘‘what proper usage, reduce the potential for However, an unintended consequence does this name mean to you?’’—type medication errors, do not mislead HCPs of including these options is that they question for each name. or patients regarding non-approved use can facilitate satisficing, where (Response 13) The approach of the drug, and increase the chance that participants who have enough described in this comment is one if a patient does ask an HCP about a information to form a relevant judgment method to approach the issue of certain medication then that medication nonetheless choose ‘‘don’t know’’/‘‘no broadening the indication and may be would be one approved to treat a opinion’’/‘‘none’’ because it takes less useful for future research. However, in condition with which the patient has effort. As a result, ‘‘don’t know’’/‘‘no the current study we aim to collect been diagnosed. opinion’’/‘‘none’’ options do not tend to information about multiple names, (Response 16) The purpose of the improve measurement and tend to which precludes open-ended questions current study is to provide evidence increase item nonresponse (i.e., missing for each name in a single participant about whether certain types of names data) (Ref. 1). For these reasons, we will session. Moreover, our initial influence consumers’ perceptions, as not add these options. examination is focused on well as benefit and risk perceptions so (Comment 10) Seven comments overstatement of efficacy. Broadening of that FDA reviewers may better assess suggested adding more open-ended the indication is another topic that names during premarket review. Other responses to explain why respondents researchers could pursue. effects of names are beyond the scope of answered questions in certain ways. (Comment 14) One comment the current study but may be considered (Response 10) As noted by two mentioned that we had no particular in future research. comments the survey may be longer items on the issue of unique (Comment 17) One comment than an average of 20 minutes, which composition and suggested adding an suggested the ability of HCPs who will cause us to remove questions after open-ended question regarding general prescribe drug products to determine cognitive testing. Unfortunately, it is associations to determine whether a whether a proprietary name overstates impractical to include many open- particular ingredient or dosage the efficacy of that product without the ended questions in this particular formulation is implied by a proprietary ability to review the respective package research because of time constraints. name. insert labeling fails to meet the intent of Qualitative research on this topic may (Response 14) Our current research is 21 U.S.C. 321(n). The comment further be a good idea for a future study. focused on the issue of overstatement of stated that OPDP and the sponsor of the (Comment 11) One comment efficacy in proposed proprietary drug product are in the best position to recommended checks to ensure that names. Future research could examine determine the relationship between the respondents are not being careless in issues related to composition and proprietary name and the material facts their responses (e.g., just guessing, dosage formulation, but that is beyond in the labeling of the product, which providing random answers, straight- the scope of the current research. sometimes is not available at the lining). (Comment 15) One comment investigational new drug (IND) (Response 11) We intend to check for suggested FDA should conduct two application stage when proprietary inattentive respondents by testing for survey pretests: One to assess whether names are developed and tested with straight-lining and examining the the survey answers the research consumers and HCPs. distribution of time to complete the questions, and one that allows (Response 17) The purpose of the study for outliers. Participants who respondents to complete the survey current study is to determine whether a complete the study plus or minus three under the supervision of a moderator, proprietary name itself could play a role standard deviations from the sample who is able to converse with in influencing consumer and HCP mean will be excluded from the main respondents and gather feedback on perceptions of drug risks or benefits by analysis. We agree with the how participants interpret the suggesting the medical condition for recommendation to include speed traps/ questions. Further, the comment which the drug is indicated or by attention checks in the questionnaire suggests FDA should consider suggesting an overstatement of the and will add one to the study. conducting qualitative followup efficacy of the drug. Including the (Comment 12) Three comments interviews with survey respondents to package insert would confound any requested access to the screener or study gain deeper insight into how the sample potential results of this study, as it target names. proprietary names affected their would not be possible to tease apart

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whether perceptions were influenced by sample size be used, and another that there is or is not improper the name itself or the accompanying comment remarked that the sample size suggestiveness. materials. We note that this is a large- seemed appropriate. (Response 23) There is an important scale study examining multiple names (Response 20) The sample size was distinction between investigating the and that our purpose in conducting it selected based on power analysis. We effect of a prescription drug name on differs from that of a pharmaceutical have set statistical power for the main perceptions and establishing that the company engaged in developing and study to test five proposed names name is improperly suggestive. This testing the proprietary name of one of its against both the neutral control name study is focused on the effect on products. and the extreme control name, using a perceptions of: (1) Names that suggest (Comment 18) One comment 7 × 7 Latin squares design. With a the medical condition for which a drug suggested that the proposed primary Bonferroni correction for up to 10 is indicated with varying degrees of research question, which is designed to pairwise comparisons, the study is explicitness and (2) names that suggest determine how, if at all, a proprietary powered to detect conventionally small an overstatement of the efficacy of the name that suggests the medical effects (f ≥ 0.06, dz ≥ 0.21, or 0.14 drug with varying degrees of condition for which it is indicated difference in proportions) assuming a explicitness. Determining whether what affects perceptions of the drug, does not family-wise alpha level of 0.005 and 90 a prescription drug name suggests or the determine whether a name overstates percent power for all tests. name’s degree of suggestiveness is the efficacy of the product. This is a large-scale study examining ‘‘improper,’’ or could contribute to (Response 18) We agree that whether multiple names, whose purpose differs misbranding the drug or to other a name suggests the medical condition from that of one pharmaceutical violation(s) of the FD&C Act and Agency for which a drug is indicated is a company assessing their chosen names. regulations, falls beyond the scope of separate question from whether the (Comment 21) One comment the current project. name overstates the drug’s efficacy. concurred that an automated online (Comment 24) One comment However, we aim, in part, to investigate survey would be the most efficient suggested clarifying the purpose and how individuals perceive the efficacy of means to conduct the research. intended use of the data and further products when the names do suggest the (Response 21) Thank you for this suggests that regardless of the purpose medical condition they are indicated to comment. of the proposed information collection, treat. The purpose of this study is to (Comment 22) One comment asked in addressing use of the survey data, compare names that: (1) With varying that we clarify what specific statistical FDA should account for the First degrees of specificity, may suggest the Amendment protection provided to medical condition for which a drug is tests will be performed to determine proprietary names. indicated, with or without varied whether a particular target name has an promises of effect (target names); (2) we improper (biasing) impact on (Response 24) As stated in the 60-day know through pretesting overstate the perceptions of drug efficacy and/or notice, the purpose of this study is to efficacy (extreme names); and (3) we safety—and (possibly) on other expand the body of knowledge by know to be neutral through pretesting. perceptions. answering questions about whether Perceptions of consumers and HCPs are (Response 22) To compare names names alone impact consumer and important to consider when reviewing based on the categorical name provider perceptions of a drug. This proprietary names and thus, important recognition and perceived indication information will help inform the to test empirically. questions, we will apply nonparametric proprietary name review process. FDA’s (Comment 19) One comment tests of dependent proportions. First, we review of proprietary names is suggested that research is not necessary plan to conduct Cochran’s Q test conducted to help ensure that proposed because names should be evaluated by separately for each list of names, testing proprietary names do not contribute to those who have medical and regulatory whether the proportions of at least two misbranding a drug or to other experience. names per list are significantly different violation(s) of the FD&C Act and Agency (Response 19) We agree that people from one another. We will follow up regulations, particularly when that who are knowledgeable about the significant Cochran’s Q tests with proprietary name appears in labeling relevant fields should make decisions McNemar’s pairwise tests, comparing (see, e.g., 21 U.S.C. 321(n) and 352(a)). about proprietary names based on the each target name against the neutral and We conduct our review of proprietary best information in their fields. extreme names in each list. names in accordance with applicable Determining how names are processed To test for evidence of mean legal authorities, including the First and understood by consumers and HCPs differences by drug name on interval- Amendment. is important information to be level outcomes (e.g., perceived efficacy (Comment 25) One comment considered in the review of these magnitude, perceived severity of risks, suggested Q1 should have a timer names. Therefore, this research is being and perceived balance of risks and element (i.e., 15–20 seconds) for each conducted to increase the body of benefits), we will use repeated-measures set of seven names that will help to evidence upon which experts can rely analyses of variance or mixed model standardize the time spent by viewers when assessing proposed proprietary analysis. We will run separate models on both sets and mitigate viewers who names for misbranding concerns. for each list of names and study cohort. would quickly scan Set 1, only to spend (Comment 20) Three comments We will follow-up significant omnibus more time on Set 2 after realizing they mentioned the study sample size. One tests by conducting pairwise will be asked to recognize the names. comment stated that the reason for comparisons between each of the target (Response 25) In addition to selecting approximately 1000 names versus the neutral and extreme counterbalancing the sets of names, we respondents was not provided, and it names. will institute a time limit for each suggested that the size of such a study See information about the study’s viewing. on a proposed drug product would not statistical power assumptions above. (Comment 26) Another comment be reasonable or cost effective for the (Comment 23) One comment asked for suggested that for Q1, we use names that pharmaceutical industry. One comment clarity regarding what decision rule or were found unacceptable due to recommended that an appropriate norm/standard will be used to conclude promotional reasons for foils.

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(Response 26) The purpose of Q1 is to condition for which the drug is recommended by prominent attitude determine how well participants recall indicated, though we will consider this theorists (Ref. 2). We have used these the names they viewed. The foils are mediation effect as we refine the items in several studies without any used to help determine whether analysis plan for this project. issues, including studies measuring participants are merely checking off the (Comment 29) One comment consumer and physician attitudes complete list of names or marking ones suggested that Q4 does not seem toward prescription drugs. Nevertheless, they truly saw on the previous screen. relevant since serious side effects of the we will replace the negative-positive Thus, we do not believe using actual drug would normally be evaluated in item with an item using worthless- names as foils would add value. the context of the clinical studies or valuable as endpoints. (Comment 27) One comment post-marketing studies and would be (Comment 32) Five comments mentioned that Q3–Q7 introduce an presented in the package insert labeling. suggested reducing or eliminating Q7, aided portion of the survey (by grouping (Response 29) The question is which questions participants about their names into two specific medical whether the name alone influences attitudes toward the drug names. conditions and identifying those names perception of risk and benefit; thus, Q4 (Response 32) As noted in Response with each medical condition to the is directly relevant to answering those 17, in the interest of reducing time respondents) and suggested that, questions. burden for participants, we will delete without seeing the product profile, ‘‘it (Comment 30) Three comments this question. will be difficult to get responsible data suggested deleting Q5. For example, one on efficacy perceptions of the comment discussed that perceived (Comment 33) Two comments respondents.’’ Another comment balance of risks and benefits is usually questioned the utility of or suggested that Q3 should ask a more communicated in advertising by recommended deleting Q8. specific question, perhaps on unique utilizing the approved labeling in (Response 33) We agree and will effectiveness or overstatement of presenting fair balance and, thus, a delete this item. efficacy. proprietary name would not normally (Comment 34) Two comments (Response 27) Our research questions present risks and benefits. The comment suggested that Q9 and two comments focus on whether the names alone result stated that names that do present suggested that Q10 and Q11 are not in perceptions of risk or efficacy, thus, benefits within the name without applicable to the objectives of this Q3–Q7 are directly relevant to the context to its risk would not be survey. research questions. Regarding Q3, we do considered misleading since the (Response 34) Similarity, typicality, not want to lead participants into approved labeling would represent and familiarity could reasonably answers or confuse them by asking them balance of risks and benefits. influence perceptions of drug names about regulatory terms with which they (Response 30) Our research questions independently of the experimental are unfamiliar. We will delete Q7. focus on whether the proprietary name manipulation. These measures are being (Comment 28) Regarding Q2, one alone affects consumer and HCP included in this study as potential comment suggested caution in terms of perceptions of risk or efficacy of the covariates. handling responses in which drug. Q5 helps to answer those research respondents presented with a particular questions by asking participants to (Comment 35) One comment target name (e.g., ‘‘AltAFlux’’) fail to opine on whether the proprietary name suggested that Q11 is confusing, as identify the indication that the name is alone indicates to them that the benefits respondents are asked to rate if they hypothesized to be suggestive of (e.g., of a product outweigh the risks. Our ‘‘have heard of each of the following ‘‘Acid Reflux’’), checking another research will not answer the question drug names before,’’ after being indication instead (e.g., ‘‘Asthma’’). In whether a given name is misleading or previously told in the questionnaire such cases, it would be inappropriate to whether labeling or advertising introduction that the drugs ‘‘have been interpret any observed effects on drug incorporating the name would violate recently developed’’ and before being perceptions to the name being overly the FD&C Act and its implementing informed in the debriefing that the suggestive of a particular indication. A regulations. names are fictitious. Moreover, some conservative course of action would (Comment 31) One comment respondents could interpret the present therefore be to remove from subsequent suggested that measuring attitudes question as meaning ‘‘Were the analyses all instances in which a target toward each name (Q6) does not seem following names mentioned in this name is not attributed to its to add anything toward measuring the survey?’’ which is presumably not the hypothesized indication. efficacy claims of a name and another intent of the question. (Response 28) The target names are comment recommends changing (Response 35) We agree that this item representative of the types of names that semantic differential endpoints for this as written was confusing, and this was are frequently submitted to FDA for item. confirmed by cognitive testing. Thus, review. They may include information (Response 31) Measuring attitudes we will alter the question to clarify that about the medical condition for which adds to our knowledge of how we are interested in whether the drug is indicated, or both the individuals interpret particular drug respondents had heard the drug name medical condition and efficacy. We do names. The semantic differential prior to the study. This question will be not presuppose that a name’s effect on endpoints used in the original attitude used as a covariate in the study design. perceptions of drug effectiveness are question, as well as the proposed FDA estimates the burden of this dependent on recognition of the medical replacements, are among those collection of information as follows:

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

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

Consumer Screener ...... 1,233 1 1,233 .08 (5 minutes) ...... 98.64

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TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued

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

HCP Screener ...... 1,233 1 1,233 .08 (5 minutes) ...... 98.64 Consumer Study ...... 493 1 493 .33 (20 minutes) ...... 162.69 HCP Study ...... 493 1 493 .33 (20 minutes) ...... 162.69

Total ...... 522.66 1 There are no capital costs or operating and maintenance costs associated with this collection of information.

References for HINTERMANN SERIES H3 TOTAL third party may not wish to be posted, The following references are on ANKLE REPLACEMENT SYSTEM and such as medical information, your or display with the Dockets Management is publishing this notice of that anyone else’s Social Security number, or Staff, HFA–305, Food and Drug determination as required by law. FDA confidential business information, such Administration, 5630 Fishers Lane, has made the determination because of as a manufacturing process. Please note Room 1061, Rockville, MD 20852, 240– the submission of an application to the that if you include your name, contact 402–7500 and are available for viewing Director of the U.S. Patent and information, or other information that by interested persons between 9 a.m. Trademark Office (USPTO), Department identifies you in the body of your and 4 p.m., Monday through Friday; of Commerce, for the extension of a comments, that information will be these are not available electronically at patent which claims that medical posted on https://www.regulations.gov. • If you want to submit a comment https://www.regulations.gov as these device. with confidential information that you references are copyright protected. DATES: Anyone with knowledge that any do not wish to be made available to the Some may be available at the website of the dates as published (see public, submit the comment as a address, if listed. FDA has verified the SUPPLEMENTARY INFORMATION) are written/paper submission and in the website addresses, as of the date this incorrect may submit either electronic manner detailed (see ‘‘Written/Paper or written comments and ask for a document publishes in the Federal Submissions’’ and ‘‘Instructions’’). Register, but websites are subject to redetermination by May 17, 2021. change over time. Furthermore, any interested person may Written/Paper Submissions 1. Krosnick, J.A. and S. Presser, petition FDA for a determination Submit written/paper submissions as ‘‘Question and Questionnaire regarding whether the applicant for follows: Design.’’ In P.V. Marsden and J.D. extension acted with due diligence • Mail/Hand Delivery/Courier (for Wright (Eds.). Handbook of Survey during the regulatory review period by written/paper submissions): Dockets Research (2nd Ed.). Emerald: September 13, 2021. See ‘‘Petitions’’ in Management Staff (HFA–305), Food and Bingley, UK, 2010. the SUPPLEMENTARY INFORMATION section Drug Administration, 5630 Fishers 2. Fishbein, M. and I. Ajzen, Predicting for more information. Lane, Rm. 1061, Rockville, MD 20852. and Changing Behavior: The ADDRESSES: You may submit comments • For written/paper comments Reasoned Action Approach. New as follows. Please note that late, submitted to the Dockets Management York, NY: Psychology Press, 2010. untimely filed comments will not be Staff, FDA will post your comment, as Dated: March 9, 2021. considered. Electronic comments must well as any attachments, except for information submitted, marked and Lauren K. Roth, be submitted on or before May 17, 2021. The https://www.regulations.gov identified, as confidential, if submitted Acting Principal Associate Commissioner for as detailed in ‘‘Instructions.’’ Policy. electronic filing system will accept comments until 11:59 p.m. Eastern Time Instructions: All submissions received [FR Doc. 2021–05330 Filed 3–15–21; 8:45 am] at the end of May 17, 2021. Comments must include the Docket No. FDA– BILLING CODE 4164–01–P received by mail/hand delivery/courier 2020–E–0340 for ‘‘Determination of (for written/paper submissions) will be Regulatory Review Period for Purposes considered timely if they are of Patent Extension; HINTERMANN DEPARTMENT OF HEALTH AND SERIES H3 TOTAL ANKLE HUMAN SERVICES postmarked or the delivery service acceptance receipt is on or before that REPLACEMENT SYSTEM.’’ Received Food and Drug Administration date. comments, those filed in a timely manner (see ADDRESSES), will be placed [Docket No. FDA–2020–E–0340] Electronic Submissions in the docket and, except for those Submit electronic comments in the submitted as ‘‘Confidential Determination of Regulatory Review following way: Submissions,’’ publicly viewable at Period for Purposes of Patent • Federal eRulemaking Portal: https://www.regulations.gov or at the Extension; HINTERMANN SERIES H3 https://www.regulations.gov. Follow the Dockets Management Staff between 9 TOTAL ANKLE REPLACEMENT instructions for submitting comments. a.m. and 4 p.m., Monday through SYSTEM Comments submitted electronically, Friday, 240–402–7500. • AGENCY: Food and Drug Administration, including attachments, to https:// Confidential Submissions—To HHS. www.regulations.gov will be posted to submit a comment with confidential ACTION: Notice. the docket unchanged. Because your information that you do not wish to be comment will be made public, you are made publicly available, submit your SUMMARY: The Food and Drug solely responsible for ensuring that your comments only as a written/paper Administration (FDA or the Agency) has comment does not include any submission. You should submit two determined the regulatory review period confidential information that you or a copies total. One copy will include the

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information you claim to be confidential an approval phase. For medical devices, of the device: August 17, 2006. FDA has with a heading or cover note that states the testing phase begins with a clinical verified the applicant’s claim that the ‘‘THIS DOCUMENT CONTAINS investigation of the device and runs date on which the device is first used CONFIDENTIAL INFORMATION.’’ The until the approval phase begins. The with human subjects as part of a clinical Agency will review this copy, including approval phase starts with the initial investigation to be filed with FDA to the claimed confidential information, in submission of an application to market secure premarket approval of the device its consideration of comments. The the device and continues until was August 17, 2006. second copy, which will have the permission to market the device is claimed confidential information granted. Although only a portion of a 2. The date an application was redacted/blacked out, will be available regulatory review period may count initially submitted with respect to the for public viewing and posted on toward the actual amount of extension device under section 515 of the FD&C https://www.regulations.gov. Submit that the Director of USPTO may award Act (21 U.S.C. 360e): August 24, 2016. both copies to the Dockets Management (half the testing phase must be FDA has verified the applicant’s claim Staff. If you do not wish your name and subtracted as well as any time that may that the premarket approval application contact information to be made publicly have occurred before the patent was (PMA) for HINTERMANN SERIES H3 available, you can provide this issued), FDA’s determination of the TOTAL ANKLE REPLACEMENT information on the cover sheet and not length of a regulatory review period for SYSTEM (PMA 160036) was initially in the body of your comments and you a medical device will include all of the submitted August 24, 2016. must identify this information as testing phase and approval phase as 3. The date the application was specified in 35 U.S.C. 156(g)(3)(B). ‘‘confidential.’’ Any information marked approved: June 4, 2019. FDA has as ‘‘confidential’’ will not be disclosed FDA has approved for marketing the medical device HINTERMANN SERIES verified the applicant’s claim that PMA except in accordance with § 10.20 (21 160036 was approved on June 4, 2019. CFR 10.20) and other applicable H3 TOTAL ANKLE REPLACEMENT disclosure law. For more information SYSTEM. HINTERMANN SERIES H3 This determination of the regulatory about FDA’s posting of comments to TOTAL ANKLE REPLACEMENT review period establishes the maximum public dockets, see 80 FR 56469, SYSTEM is indicated for use as a non- potential length of a patent extension. September 18, 2015, or access the cemented implant to replace a painful However, the USPTO applies several information at: https:// arthritic ankle joint due to primary statutory limitations in its calculations www.govinfo.gov/content/pkg/FR-2015- osteoarthritis, post-traumatic of the actual period for patent extension. 09-18/pdf/2015-23389.pdf. osteoarthritis, or arthritis secondary to In its application for patent extension, Docket: For access to the docket to inflammatory disease (e.g., rheumatoid this applicant seeks 1,825 days of patent read background documents or the arthritis, hemochromatosis, etc.). The term extension. electronic and written/paper comments device system is for prescription use. received, go to https:// Subsequent to this approval, the USPTO III. Petitions received a patent term restoration www.regulations.gov and insert the Anyone with knowledge that any of docket number, found in brackets in the application for HINTERMANN SERIES H3 TOTAL ANKLE REPLACEMENT the dates as published are incorrect may heading of this document, into the submit either electronic or written ‘‘Search’’ box and follow the prompts SYSTEM (U.S. Patent No. 6,409,767) comments and, under 21 CFR 60.24, ask and/or go to the Dockets Management from European Foot Platform, and the for a redetermination (see DATES). Staff, 5630 Fishers Lane, Rm. 1061, USPTO requested FDA’s assistance in Furthermore, as specified in § 60.30 (21 Rockville, MD 20852, 240–402–7500. determining this patent’s eligibility for patent term restoration. In a letter dated CFR 60.30), any interested person may FOR FURTHER INFORMATION CONTACT: July 14, 2020, FDA advised the USPTO petition FDA for a determination Beverly Friedman, Office of Regulatory that this medical device had undergone regarding whether the applicant for Policy, Food and Drug Administration, a regulatory review period and that the extension acted with due diligence 10903 New Hampshire Ave., Bldg. 51, approval of HINTERMANN SERIES H3 during the regulatory review period. To Rm. 6250, Silver Spring, MD 20993, TOTAL ANKLE REPLACEMENT 301–796–3600. meet its burden, the petition must SYSTEM represented the first permitted comply with all the requirements of SUPPLEMENTARY INFORMATION: commercial marketing or use of the § 60.30, including but not limited to: I. Background product. Thereafter, the USPTO Must be timely (see DATES), must be requested that FDA determine the filed in accordance with § 10.20, must The Drug Price Competition and product’s regulatory review period. Patent Term Restoration Act of 1984 contain sufficient facts to merit an FDA (Pub. L. 98–417) and the Generic II. Determination of Regulatory Review investigation, and must certify that a Animal Drug and Patent Term Period true and complete copy of the petition Restoration Act (Pub. L. 100–670) FDA has determined that the has been served upon the patent generally provide that a patent may be applicable regulatory review period for applicant. (See H. Rept. 857, part 1, 98th extended for a period of up to 5 years HINTERMANN SERIES H3 TOTAL Cong., 2d sess., pp. 41–42, 1984.) so long as the patented item (human ANKLE REPLACEMENT SYSTEM is Petitions should be in the format drug product, animal drug product, 4,676 days. Of this time, 3,661 days specified in 21 CFR 10.30. medical device, food additive, or color occurred during the testing phase of the Submit petitions electronically to additive) was subject to regulatory regulatory review period, while 1,015 https://www.regulations.gov at Docket review by FDA before the item was days occurred during the approval No. FDA–2013–S–0610. Submit written marketed. Under these acts, a product’s phase. These periods of time were petitions (two copies are required) to the regulatory review period forms the basis derived from the following dates: Dockets Management Staff (HFA–305), for determining the amount of extension 1. The date on which the device is Food and Drug Administration, 5630 an applicant may receive. first used with human subjects as part A regulatory review period consists of of a clinical investigation to be filed Fishers Lane, Rm. 1061, Rockville, MD two periods of time: A testing phase and with FDA to secure premarket approval 20852.

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Dated: March 9, 2021. ACTION: Notice. 796–3137, Kimberly.Lehrfeld@ Lauren K. Roth, fda.hhs.gov. Acting Principal Associate Commissioner for SUMMARY: The Food and Drug Policy. Administration (FDA or Agency) is SUPPLEMENTARY INFORMATION: The [FR Doc. 2021–05371 Filed 3–15–21; 8:45 am] withdrawing approval of 19 new drug applicants listed in the table have BILLING CODE 4164–01–P applications (NDAs) from multiple informed FDA that these drug products applicants. The applicants notified the are no longer marketed and have Agency in writing that the drug requested that FDA withdraw approval DEPARTMENT OF HEALTH AND products were no longer marketed and of the applications under the process in HUMAN SERVICES requested that the approval of the § 314.150(c) (21 CFR 314.150(c)). The applications be withdrawn. applicants have also, by their requests, Food and Drug Administration DATES: Approval is withdrawn as of waived their opportunity for a hearing. [Docket No. FDA–2021–N–0212] April 15, 2021. Withdrawal of approval of an FOR FURTHER INFORMATION CONTACT: application or abbreviated application Bristol-Meyers Squibb Company, et al.; Kimberly Lehrfeld, Center for Drug under § 314.150(c) is without prejudice Withdrawal of Approval of 19 New to refiling. Drug Applications Evaluation and Research, Food and Drug Administration, 10903 New AGENCY: Food and Drug Administration, Hampshire Ave., Bldg. 51, Rm. 6226, HHS. Silver Spring, MD 20993–0002, 301–

Application No. Drug Applicant

NDA 009218 ...... Coumadin (warfarin sodium) Tablets, 1 milligram (mg), 2 mg, Bristol-Myers Squibb Co., P.O. Box 4000, Princeton, NJ 2.5 mg, 3 mg, 4 mg, 5 mg, 6 mg, 7.5 mg, and 10 mg. 08543. Coumadin (warfarin sodium) Injection, 5 mg/vial, 50 mg/vial, and 75 mg/vial. NDA 011664 ...... Decadron (dexamethasone) Tablets, 0.25 mg, 0.5 mg, 0.75 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., mg, 1.5 mg, 4 mg, and 6 mg. Inc., 1 Merck Dr., Whitehouse Station, NJ 08889. NDA 017481 ...... Vermox (mebendazole) Chewable Tablets, 100 mg ...... Janssen Pharmaceuticals, Inc., 1125 Trenton-Harbourton Rd., Titusville, NJ 08560. NDA 018538 ...... Lozol (indapamide) Tablets, 1.25 mg, and 2.5 mg ...... Sanofi-aventis U.S. LLC, 55 Corporate Dr., Bridgewater, NJ 08807. NDA 018986 ...... Pralidoxime Chloride Injection (auto-injector), 600 mg/2 milli- Meridian Medical Technologies, Inc., 1945 Craig Rd., St. liters (mL) (300 mg/mL). Louis, MO 63146. NDA 019999 ...... Morphine Sulfate Injection (auto-injector), 10 mg/0.7 mL ...... Do. NDA 020363 ...... Famvir (famciclovir) Tablets, 125 mg, 250 mg, and 500 mg ... Novartis Pharmaceuticals Corp., 1 Health Plaza, East Han- over, NJ 07936–1080. NDA 020711 ...... Zyban (bupropion hydrochloride (HCl)) Extended-Release GlaxoSmithKline LLC, 5 Crescent Dr., Philadelphia, PA Tablets, 100 mg, and 150 mg. 19112. NDA 020809 ...... Diclofenac Sodium Ophthalmic Solution, 0.1% ...... Alcon Research, LLC, 6201 South Freeway, Fort Worth, TX 76134. NDA 021713 ...... Abilify (aripiprazole) Oral Solution, 1 mg/mL ...... Otsuka Pharmaceutical Co., Ltd. c/o Otsuka Pharmaceutical Development & Commercialization, Inc., 2440 Research Blvd., Rockville, MD 20850. NDA 021729 ...... Abilify (aripiprazole) Discmelt Orally Disintegrating Tablets, Do. 10 mg, 15 mg, 20 mg, and 30 mg. NDA 021866 ...... Abilify (aripiprazole) Injection, 9.75 mg/1.3 mL (7.5 mg/mL) ... Do. NDA 022024 ...... Actoplus Met XR (metformin HCl and pioglitazone) Extended- Takeda Pharmaceutical U.S.A. Inc., 95 Hayden Ave., Lex- Release Tablets, 1gram (g)/Equivalent to (EQ) 15 mg base ington, MA 02421. and 1 g/EQ 30 mg base. NDA 050605 ...... Ceftin (cefuroxime axetil) Tablets, EQ 125 mg base, EQ 250 GlaxoSmithKline Intellectual Property (no. 2) Ltd. England, c/ mg base, and EQ 500 mg base. o GlaxoSmithKline, 1250 South Collegeville Rd., Collegeville, PA 19426. NDA 050672 ...... Ceftin (cefuroxime axetil) Oral Suspension, EQ 125 mg base/ Do. 5 mL and EQ 250 mg base/5 mL. NDA 207988 ...... Zurampic (lesinurad) Tablets, 200mg ...... Ironwood Pharmaceuticals, Inc., 100 Summer St., Suite 2300, Boston MA 02110. NDA 208383 ...... Bevyxxa (betrixaban) Capsules, 40 mg and 80 mg ...... Portola Pharmaceuticals, Inc., 270 East Grand Ave., South San Francisco, CA 94080. NDA 210709 ...... Tekturna (aliskiren hemifumarate) Capsules (Pellets), EQ Nodem Pharma DAC, 4820 Emperor Blvd., Durham, NC 37.5 mg base. 27703. NDA 210874 ...... Qternmet XR (dapagliflozin, metformin HCl and saxagliptin) AstraZeneca AB, c/o AstraZeneca Pharmaceuticals LP, 1800 Extended-Release Tablets, 2.5 mg/1 g/EQ 2.5 mg base, 5 Concord Pike, Wilmington, DE 19803. mg/1 g/EQ 2.5 mg base, 5 mg/1 g/EQ 5 mg base, and 10 mg/1 g/EQ 5 mg base.

Therefore, approval of the application is withdrawn, including any without approved new drug applications listed in the table, and all strengths and dosage forms applications violates section 301(a) and amendments and supplements thereto, inadvertently missing from the table. (d) of the Federal Food, Drug, and is hereby withdrawn as of April 15, Introduction or delivery for introduction Cosmetic Act (21 U.S.C. 331(a) and (d)). 2021. Approval of each entire into interstate commerce of products Drug products that are listed in the table

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that are in inventory on April 15, 2021 Electronic Submissions ‘‘THIS DOCUMENT CONTAINS may continue to be dispensed until the Submit electronic comments in the CONFIDENTIAL INFORMATION.’’ The inventories have been depleted or the following way: Agency will review this copy, including drug products have reached their • Federal eRulemaking Portal: the claimed confidential information, in expiration dates or otherwise become https://www.regulations.gov. Follow the its consideration of comments. The violative, whichever occurs first. instructions for submitting comments. second copy, which will have the Dated: March 9, 2021. Comments submitted electronically, claimed confidential information Lauren K. Roth, including attachments, to https:// redacted/blacked out, will be available for public viewing and posted on Acting Principal Associate Commissioner for www.regulations.gov will be posted to Policy. the docket unchanged. Because your https://www.regulations.gov. Submit comment will be made public, you are both copies to the Dockets Management [FR Doc. 2021–05368 Filed 3–15–21; 8:45 am] Staff. If you do not wish your name and BILLING CODE 4164–01–P solely responsible for ensuring that your comment does not include any contact information to be made publicly confidential information that you or a available, you can provide this DEPARTMENT OF HEALTH AND third party may not wish to be posted, information on the cover sheet and not HUMAN SERVICES such as medical information, your or in the body of your comments and you anyone else’s Social Security number, or must identify this information as Food and Drug Administration confidential business information, such ‘‘confidential.’’ Any information marked as a manufacturing process. Please note as ‘‘confidential’’ will not be disclosed except in accordance with 21 CFR 10.20 [Docket No. FDA–2002–N–0314] that if you include your name, contact information, or other information that and other applicable disclosure law. For Agency Information Collection identifies you in the body of your more information about FDA’s posting Activities; Proposed Collection; comments, that information will be of comments to public dockets, see 80 Comment Request; Request for posted on https://www.regulations.gov. FR 56469, September 18, 2015, or access Samples and Protocols • If you want to submit a comment the information at: https:// with confidential information that you www.govinfo.gov/content/pkg/FR-2015- AGENCY: Food and Drug Administration, do not wish to be made available to the 09-18/pdf/2015-23389.pdf. HHS. public, submit the comment as a Docket: For access to the docket to ACTION: Notice. written/paper submission and in the read background documents or the manner detailed (see ‘‘Written/Paper electronic and written/paper comments SUMMARY: The Food and Drug Submissions’’ and ‘‘Instructions’’). received, go to https:// www.regulations.gov and insert the Administration (FDA, Agency, or we) is Written/Paper Submissions announcing an opportunity for public docket number, found in brackets in the comment on the proposed collection of Submit written/paper submissions as heading of this document, into the certain information by the Agency. follows: ‘‘Search’’ box and follow the prompts Under the Paperwork Reduction Act of • Mail/Hand Delivery/Courier (for and/or go to the Dockets Management 1995 (PRA), Federal Agencies are written/paper submissions): Dockets Staff, 5630 Fishers Lane, Rm. 1061, required to publish notice in the Management Staff (HFA–305), Food and Rockville, MD 20852, 240–402–7500. Federal Register concerning each Drug Administration, 5630 Fishers FOR FURTHER INFORMATION CONTACT: Ila proposed collection of information, Lane, Rm. 1061, Rockville, MD 20852. • S. Mizrachi, Office of Operations, Food including each proposed extension of an For written/paper comments and Drug Administration, Three White existing collection of information, and submitted to the Dockets Management Flint North, 10A–12M, 11601 to allow 60 days for public comment in Staff, FDA will post your comment, as Landsdown St., North Bethesda, MD response to the notice. This notice well as any attachments, except for 20852, 301–796–7726, PRAStaff@ solicits comments on the information information submitted, marked and fda.hhs.gov. collection requirements relating to the identified, as confidential, if submitted regulations that state that protocols for as detailed in ‘‘Instructions.’’ SUPPLEMENTARY INFORMATION: Under the samples of biological products must be Instructions: All submissions received PRA (44 U.S.C. 3501–3521), Federal submitted to the Agency. must include the Docket No. FDA– Agencies must obtain approval from the 2002–N–0314 for ‘‘Request for Samples Office of Management and Budget DATES: Submit either electronic or and Protocols.’’ Received comments, (OMB) for each collection of written comments on the collection of those filed in a timely manner (see information they conduct or sponsor. information by May 17, 2021. ADDRESSES), will be placed in the docket ‘‘Collection of information’’ is defined ADDRESSES: You may submit comments and, except for those submitted as in 44 U.S.C. 3502(3) and 5 CFR as follows. Please note that late, ‘‘Confidential Submissions,’’ publicly 1320.3(c) and includes Agency requests untimely filed comments will not be viewable at https://www.regulations.gov or requirements that members of the considered. Electronic comments must or at the Dockets Management Staff public submit reports, keep records, or be submitted on or before May 17, 2021. between 9 a.m. and 4 p.m., Monday provide information to a third party. The https://www.regulations.gov through Friday, 240–402–7500. Section 3506(c)(2)(A) of the PRA (44 electronic filing system will accept • Confidential Submissions—To U.S.C. 3506(c)(2)(A)) requires Federal comments until 11:59 p.m. Eastern Time submit a comment with confidential Agencies to provide a 60-day notice in at the end of May 17, 2021. Comments information that you do not wish to be the Federal Register concerning each received by mail/hand delivery/courier made publicly available, submit your proposed collection of information, (for written/paper submissions) will be comments only as a written/paper including each proposed extension of an considered timely if they are submission. You should submit two existing collection of information, postmarked or the delivery service copies total. One copy will include the before submitting the collection to OMB acceptance receipt is on or before that information you claim to be confidential for approval. To comply with this date. with a heading or cover note that states requirement, FDA is publishing notice

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of the proposed collection of of manufacture of the product, these products may still be required for information set forth in this document. including all results of each test for surveillance, licensing, and export With respect to the following which test results are requested by purposes, or in the event that FDA collection of information, FDA invites CBER. After official release is no longer obtains information that the comments on these topics: (1) Whether required, one sample along with a manufacturing process may not result in the proposed collection of information protocol is required to be submitted at consistent quality of the product. is necessary for the proper performance 90-day intervals. In addition, samples, The following burden estimate is for of FDA’s functions, including whether which must be accompanied by a the protocols required to be submitted the information will have practical protocol, may at any time be required to with each sample. The collection of utility; (2) the accuracy of FDA’s be submitted to CBER if continued samples is not a collection of estimate of the burden of the proposed evaluation is deemed necessary. information under 5 CFR 1320.3(h)(2). collection of information, including the Section 660.36(a) requires, after each Respondents to the collection of validity of the methodology and routine establishment inspection by information under § 610.2 are assumptions used; (3) ways to enhance FDA, the submission of samples from a manufacturers of licensed biological the quality, utility, and clarity of the lot of final Reagent Red Blood Cell products. Respondents to the collection information to be collected; and (4) product along with a protocol of information under §§ 660.6(b), ways to minimize the burden of the containing specific information. Section 660.36(a)(2) and (b), and 660.46(b) are collection of information on 660.36(a)(2) requires that a protocol manufacturers of the specific products respondents, including through the use contain information, including, but not referenced previously in this document. of automated collection techniques, limited to, manufacturing records, The estimated number of respondents when appropriate, and other forms of certain test records, and identity test for each regulation is based on the information technology. results. Section 660.36(b) requires a annual number of manufacturers that Request for Samples and Protocols copy of the antigenic constitution submitted samples and protocols for matrix specifying the antigens present biological products, including OMB Control Number 0910–0206— or absent to be submitted to the CBER Extension submissions for lot release, surveillance, Director at the time of initial licensing, or export. Based on This information collection supports distribution of each lot. information obtained from FDA’s Agency regulations. Under section 351 Section 660.46(a) contains database system, approximately 75 of the Public Health Service Act (42 requirements as to the frequency of manufacturers submitted samples and U.S.C. 262), FDA has the responsibility submission of samples from each lot of protocols in fiscal year (FY) 2020 under to issue regulations that prescribe Hepatitis B Surface Antigen product, the regulations cited previously in this standards designed to ensure the safety, and § 660.46(b) contains the document. FDA estimates that purity, and potency of biological requirements as to the submission of a approximately 72 manufacturers products and to ensure that the protocol containing specific information submitted protocols under § 610.2, and biologics licenses for such products are along with each required sample. For 3 manufacturers submitted protocols only issued when a product meets the § 660.46 products subject to official under the regulation (§ 660.6) for the prescribed standards. Under § 610.2 (21 release by CBER, one sample from each other specific product. FDA received no CFR 610.2), the Center for Biologics filling of each lot is required to be submissions under §§ 660.36 or 660.46; Evaluation and Research (CBER) or the submitted along with a protocol however, FDA is using the estimate of Center for Drug Evaluation and Research consisting of a summary of the history one protocol submission under each may at any time require manufacturers or manufacture of the product, regulation in the event that protocols are of licensed biological products to including all results of each test for submitted in the future. submit to FDA samples of any lot, along which test results are requested by with the protocols showing the results CBER. After notification of official The estimated total annual responses of applicable tests, prior to distributing release is received, one sample along are based on FDA’s final actions the lot of the product. In addition to with a protocol is required to be completed in FY 2020 for the various § 610.2, there are other regulations that submitted at 90-day intervals. In submission requirements of samples require the submission of samples and addition, samples, which must be and protocols for the licensed biological protocols for specific licensed biological accompanied by a protocol, may at any products. The average burden per products: §§ 660.6, 660.36, and 660.46 time be required to be submitted to response is based on information (21 CFR 660.6, 660.36, and 660.46). CBER if continued evaluation is deemed provided by industry. The burden Section 660.6(a) provides necessary. estimates provided by industry ranged requirements for the frequency of Samples and protocols are required by from 1 hour to 5.5 hours. Under § 610.2, submission of samples from each lot of FDA to help ensure the safety, purity, or the hours per response are based on the Antibody to Hepatitis B Surface Antigen potency of the product because of the average of these estimates and rounded product, and § 660.6(b) provides the potential lot-to-lot variability of a to 3 hours. Under the remaining requirements for the submission of a product produced from living regulations, the average burden per protocol containing specific information organisms. In cases of certain biological response is based on the higher end of along with each required sample. For products (e.g., Albumin, Plasma Protein the estimate (rounded to 5 or 6 hours) § 660.6 products subject to official Fraction, and therapeutic biological because more information is generally release by CBER, one sample from each products) that are known to have lot-to- required to be submitted in the other filling of each lot is required to be lot consistency, official lot release is not protocols than under § 610.2. submitted along with a protocol normally required. However, FDA estimates the burden of this consisting of a summary of the history submissions of samples and protocols of information collection as follows:

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TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Number of Average 21 CFR Section/activity Number of responses per Total annual burden per Total hours respondents respondent responses response

610.2, Requests for Samples and Protocols; Official Re- lease ...... 72 82.972 5,974 3 17,922 660.6(b), Protocols ...... 3 4 12 5 60 660.36(a)(2) and (b), Samples and Protocols ...... 1 1 1 6 6 660.46(b), Protocols ...... 1 1 1 5 5

Total ...... 77 ...... 5,988 ...... 17,993 1 There are no capital costs or operating and maintenance costs associated with this collection of information.

Our estimated burden for the 1, 2020 (85 FR 33169). Submit either • Mail/Hand Delivery/Courier (for information collection reflects an electronic or written comments by April written/paper submissions): Dockets overall decrease of 1,463 hours and a 15, 2021. Management Staff (HFA–305), Food and corresponding decrease of 491 ADDRESSES: You may submit comments Drug Administration, 5630 Fishers responses. We attribute this adjustment as follows. Please note that late, Lane, Rm. 1061, Rockville, MD 20852. to a decrease in the number of untimely filed comments will not be • For written/paper comments submissions we received over the last considered. Electronic comments must submitted to the Dockets Management few years. be submitted on or before April 15, Staff, FDA will post your comment, as well as any attachments, except for Dated: March 9, 2021. 2021. The https://www.regulations.gov information submitted, marked and Lauren K. Roth, electronic filing system will accept comments until 11:59 p.m. Eastern Time identified, as confidential, if submitted Acting Principal Associate Commissioner for as detailed in ‘‘Instructions.’’ Policy. at the end of April 15, 2021. Comments received by mail/hand delivery/courier Instructions: All submissions received [FR Doc. 2021–05367 Filed 3–15–21; 8:45 am] (for written/paper submissions) will be must include the Docket No. FDA– BILLING CODE 4164–01–P considered timely if they are 2020–N–1127 for ‘‘Listing of Patent postmarked or the delivery service Information in the Orange Book; Establishment of a Public Docket; DEPARTMENT OF HEALTH AND acceptance receipt is on or before that date. Request for Comments; Reopening of HUMAN SERVICES Comment Period.’’ Received comments Electronic Submissions will be placed in the docket and, except Food and Drug Administration Submit electronic comments in the for those submitted as ‘‘Confidential [Docket No. FDA–2020–N–1127] following way: Submissions,’’ publicly viewable at • Federal eRulemaking Portal: https://www.regulations.gov or at the Listing of Patent Information in the https://www.regulations.gov. Follow the Dockets Management Staff between 9 Orange Book; Establishment of a instructions for submitting comments. a.m. and 4 p.m., Monday through Public Docket; Request for Comments; Comments submitted electronically, Friday, 240–402–7500. Reopening of Comment Period including attachments, to https:// • Confidential Submissions—To www.regulations.gov will be posted to submit a comment with confidential AGENCY: Food and Drug Administration, the docket unchanged. Because your information that you do not wish to be HHS. comment will be made public, you are made publicly available, submit your ACTION: Notice; reopening of comment solely responsible for ensuring that your comments only as a written/paper period. comment does not include any submission. You should submit two confidential information that you or a copies total. One copy will include the SUMMARY: The Food and Drug third party may not wish to be posted, information you claim to be confidential Administration (FDA or the Agency) is such as medical information, your or with a heading or cover note that states reopening the comment period for the anyone else’s Social Security number, or ‘‘THIS DOCUMENT CONTAINS notice entitled ‘‘Listing of Patent confidential business information, such CONFIDENTIAL INFORMATION.’’ The Information in the Orange Book; as a manufacturing process. Please note Agency will review this copy, including Establishment of a Public Docket; that if you include your name, contact the claimed confidential information, in Request for Comments’’ that appeared in information, or other information that its consideration of comments. The the Federal Register of June 1, 2020. identifies you in the body of your second copy, which will have the The notice announced the establishment comments, that information will be claimed confidential information of a docket to solicit comments on the posted on https://www.regulations.gov. redacted/blacked out, will be available listing of patent information in the FDA • If you want to submit a comment for public viewing and posted on publication ‘‘Approved Drug Products with confidential information that you https://www.regulations.gov. Submit With Therapeutic Equivalence do not wish to be made available to the both copies to the Dockets Management Evaluations’’ (commonly known as the public, submit the comment as a Staff. If you do not wish your name and ‘‘Orange Book’’). The Agency is taking written/paper submission and in the contact information to be made publicly this action in response to the recently manner detailed (see ‘‘Written/Paper available, you can provide this enacted Orange Book Transparency Act Submissions’’ and ‘‘Instructions’’). information on the cover sheet and not of 2020, which was signed into law on in the body of your comments and you January 5, 2021. Written/Paper Submissions must identify this information as DATES: FDA is reopening the comment Submit written/paper submissions as ‘‘confidential.’’ Any information marked period for the notice published on June follows: as ‘‘confidential’’ will not be disclosed

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except in accordance with 21 CFR 10.20 Agency believes that an additional 30 The 1984 amendments include what and other applicable disclosure law. For days will allow adequate time for is now section 505(j)(7) of the Federal more information about FDA’s posting interested persons to submit comments. Food, Drug, and Cosmetic Act (21 U.S.C. of comments to public dockets, see 80 Dated: March 9, 2021. 355(j)(7)), which requires FDA to publish a list of all approved drugs. FR 56469, September 18, 2015, or access Lauren K. Roth, the information at: https:// FDA publishes this list as part of the Acting Principal Associate Commissioner for ‘‘Approved Drug Products With www.govinfo.gov/content/pkg/FR-2015- Policy. 09-18/pdf/2015-23389.pdf. Therapeutic Equivalence Evaluations,’’ Docket: For access to the docket to [FR Doc. 2021–05327 Filed 3–15–21; 8:45 am] which is known generally as the read background documents or the BILLING CODE 4164–01–P ‘‘Orange Book.’’ Under FDA regulations, electronic and written/paper comments drugs are removed from the list if the Agency withdraws or suspends received, go to https:// DEPARTMENT OF HEALTH AND approval of the drug’s NDA or ANDA www.regulations.gov and insert the HUMAN SERVICES docket number, found in brackets in the for reasons of safety or effectiveness or heading of this document, into the Food and Drug Administration if FDA determines that the listed drug ‘‘Search’’ box and follow the prompts was withdrawn from sale for reasons of and/or go to the Dockets Management [Docket No. FDA–2020–P–1678] safety or effectiveness (21 CFR 314.162). Staff, 5630 Fishers Lane, Rm. 1061, A person may petition the Agency to Rockville, MD 20852, 240–402–7500. Determination That NIPRIDE RTU determine, or the Agency may FOR FURTHER INFORMATION CONTACT: (Sodium Nitroprusside), 10 Milligrams/ determine on its own initiative, whether Nicole Park, Office of Generic Drugs, 50 Milliliters (0.2 Milligrams/Milliliters), a listed drug was withdrawn from sale Center for Drug Evaluation and Was Not Withdrawn From Sale for for reasons of safety or effectiveness. Research, Food and Drug Reasons of Safety or Effectiveness This determination may be made at any Administration, 10903 New Hampshire time after the drug has been withdrawn AGENCY: Ave., Rm. 1670, Silver Spring, MD Food and Drug Administration, from sale, but must be made prior to 20993–0002, 240–402–7764. HHS. approving an ANDA that refers to the ACTION: Notice. listed drug (§ 314.161 (21 CFR 314.161)). SUPPLEMENTARY INFORMATION: In the FDA may not approve an ANDA that Federal Register of June 1, 2020 (85 FR SUMMARY: The Food and Drug does not refer to a listed drug. 33169), FDA published a notice with a Administration (FDA or Agency) has NIPRIDE RTU (sodium nitroprusside), 90-day comment period to solicit determined that NIPRIDE RTU (sodium 10 mg/50 mL (0.2 mg/mL), is the subject comments on the listing of patent nitroprusside), 10 milligrams (mg)/50 of NDA 209387, held by Exela Pharma information in the FDA publication milliliters (mL) (0.2 mg/mL), was not Sciences, LLC, and initially approved ‘‘Approved Drug Products With withdrawn from sale for reasons of on March 8, 2017. NIPRIDE RTU is Therapeutic Equivalence Evaluations’’ safety or effectiveness. This indicated for immediate reduction of (commonly known as the ‘‘Orange determination will allow FDA to blood pressure of adult and pediatric Book’’), including comments on the approve abbreviated new drug patients in hypertensive crises; types of patent information that should applications (ANDAs) for sodium induction and maintenance of be included in the Orange Book. In the nitroprusside, 10 mg/50 mL (0.2 mg/ controlled hypotension in adults and Federal Register of October 16, 2020 (85 mL), if all other legal and regulatory children during surgery, to reduce FR 65819), FDA reopened the comment requirements are met. bleeding; and treatment of acute heart period for the public docket for an FOR FURTHER INFORMATION CONTACT: failure to reduce left ventricular end- additional 30 days in response to a Michael Bernstein, Center for Drug diastolic pressure, pulmonary capillary request for an extension to allow Evaluation and Research, Food and wedge pressure, peripheral vascular interested persons additional time to Drug Administration, 10903 New resistance, and mean arterial blood submit comments. pressure. On January 5, 2021, the President Hampshire Ave., Bldg. 51, Rm. 6240, Silver Spring, MD 20993–0002, 301– NIPRIDE RTU (sodium nitroprusside), signed into law the Orange Book 10 mg/50 mL (0.2 mg/mL), is currently Transparency Act of 2020 (Pub. L. 116– 796–3478, michael.bernstein@ fda.hhs.gov. listed in the ‘‘Discontinued Drug 290). Section 2(e) of the Orange Book Product List’’ section of the Orange Transparency Act of 2020 requires the SUPPLEMENTARY INFORMATION: In 1984, Book. Agency to solicit public comment Congress enacted the Drug Price Cardinal Health Regulatory Sciences regarding the types of patent Competition and Patent Term submitted a citizen petition dated July information that should be included on, Restoration Act of 1984 (Pub. L. 98–417) 15, 2020 (Docket No. FDA–2020–P– or removed from, the Orange Book and (the 1984 amendments), which 1678), under 21 CFR 10.30, requesting to transmit to Congress a summary of authorized the approval of duplicate that the Agency determine whether such comments and actions the Agency versions of drug products under an NIPRIDE RTU (sodium nitroprusside), is considering taking, if any, in response ANDA procedure. ANDA applicants 10 mg/50 mL (0.2 mg/mL), was to such public comment by January 5, must, with certain exceptions, show that withdrawn from sale for reasons of 2022. the drug for which they are seeking safety or effectiveness. In accordance with section 2(e) of the approval contains the same active After considering the citizen petition Orange Book Transparency Act of 2020, ingredient in the same strength and and reviewing Agency records and FDA is reopening the comment period dosage form as the ‘‘listed drug,’’ which based on the information we have at this for the public docket for 30 days, until is a version of the drug that was time, FDA has determined under April 15, 2021, to allow interested previously approved. ANDA applicants § 314.161 that NIPRIDE RTU (sodium persons time to submit any additional do not have to repeat the extensive nitroprusside), 10 mg/50 mL (0.2 mg/ comments regarding the types of patent clinical testing otherwise necessary to mL), was not withdrawn for reasons of information that should be included on, gain approval of a new drug application safety or effectiveness. The petitioner or removed from, the Orange Book. The (NDA). has identified no data or other

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information suggesting that NIPRIDE including each proposed extension of an • For written/paper comments RTU (sodium nitroprusside), 10 mg/50 existing collection of information, and submitted to the Dockets Management mL (0.2 mg/mL), was withdrawn for to allow 60 days for public comment in Staff, FDA will post your comment, as reasons of safety or effectiveness. We response to the notice. This notice well as any attachments, except for have carefully reviewed our files for solicits comments on the information information submitted, marked and records concerning the withdrawal of collection provisions associated with identified, as confidential, if submitted NIPRIDE RTU (sodium nitroprusside), export certificate applications for FDA- as detailed in ‘‘Instructions.’’ 10 mg/50 mL (0.2 mg/mL), from sale. regulated human food and cosmetic Instructions: All submissions received We have also independently evaluated products. must include the Docket No. FDA– relevant literature and data for possible 2014–N–2347 for ‘‘Agency Information DATES: Submit either electronic or postmarketing adverse events. We have Collection Activities; Proposed written comments on the collection of found no information that would Collection; Comment Request; Food and information by May 17, 2021. indicate that this drug product was Cosmetic Export Certificate Application withdrawn from sale for reasons of ADDRESSES: You may submit comments Process.’’ Received comments, those safety or effectiveness. as follows. Please note that late, filed in a timely manner (see Accordingly, the Agency will untimely filed comments will not be ADDRESSES), will be placed in the docket continue to list NIPRIDE RTU (sodium considered. Electronic comments must and, except for those submitted as nitroprusside), 10 mg/50 mL (0.2 mg/ be submitted on or before May 17, 2021. ‘‘Confidential Submissions,’’ publicly mL), in the ‘‘Discontinued Drug Product The https://www.regulations.gov viewable at https://www.regulations.gov List’’ section of the Orange Book. The electronic filing system will accept or at the Dockets Management Staff ‘‘Discontinued Drug Product List’’ comments until 11:59 p.m. Eastern Time between 9 a.m. and 4 p.m., Monday delineates, among other items, drug at the end of May 17, 2021. Comments through Friday, 240–402–7500. products that have been discontinued received by mail/hand delivery/courier • Confidential Submissions—To from marketing for reasons other than (for written/paper submissions) will be submit a comment with confidential safety or effectiveness. ANDAs that refer considered timely if they are information that you do not wish to be to NIPRIDE RTU (sodium postmarked or the delivery service made publicly available, submit your nitroprusside), 10 mg/50 mL (0.2 mg/ acceptance receipt is on or before that comments only as a written/paper mL), may be approved by the Agency as date. submission. You should submit two copies total. One copy will include the long as they meet all other legal and Electronic Submissions regulatory requirements for the approval information you claim to be confidential of ANDAs. If FDA determines that Submit electronic comments in the with a heading or cover note that states labeling for this drug product should be following way: ‘‘THIS DOCUMENT CONTAINS • revised to meet current standards, the Federal eRulemaking Portal: CONFIDENTIAL INFORMATION.’’ The Agency will advise ANDA applicants to https://www.regulations.gov. Follow the Agency will review this copy, including submit such labeling. instructions for submitting comments. the claimed confidential information, in Comments submitted electronically, Dated: March 9, 2021. its consideration of comments. The including attachments, to https:// second copy, which will have the Lauren K. Roth, www.regulations.gov will be posted to claimed confidential information Acting Principal Associate Commissioner for the docket unchanged. Because your redacted/blacked out, will be available Policy. comment will be made public, you are for public viewing and posted on [FR Doc. 2021–05324 Filed 3–15–21; 8:45 am] solely responsible for ensuring that your https://www.regulations.gov. Submit BILLING CODE 4164–01–P comment does not include any both copies to the Dockets Management confidential information that you or a Staff. If you do not wish your name and third party may not wish to be posted, contact information to be made publicly DEPARTMENT OF HEALTH AND such as medical information, your or available, you can provide this HUMAN SERVICES anyone else’s Social Security number, or information on the cover sheet and not Food and Drug Administration confidential business information, such in the body of your comments and you as a manufacturing process. Please note must identify this information as [Docket No. FDA–2014–N–2347] that if you include your name, contact ‘‘confidential.’’ Any information marked information, or other information that as ‘‘confidential’’ will not be disclosed Agency Information Collection identifies you in the body of your except in accordance with 21 CFR 10.20 Activities; Proposed Collection; comments, that information will be and other applicable disclosure law. For Comment Request; Food and posted on https://www.regulations.gov. more information about FDA’s posting Cosmetic Export Certificate • If you want to submit a comment of comments to public dockets, see 80 Application Process with confidential information that you FR 56469, September 18, 2015, or access AGENCY: Food and Drug Administration, do not wish to be made available to the the information at: https:// HHS. public, submit the comment as a www.govinfo.gov/content/pkg/FR-2015- ACTION: Notice. written/paper submission and in the 09-18/pdf/2015-23389.pdf. manner detailed (see ‘‘Written/Paper Docket: For access to the docket to SUMMARY: The Food and Drug Submissions’’ and ‘‘Instructions’’). read background documents or the Administration (FDA or we) is electronic and written/paper comments announcing an opportunity for public Written/Paper Submissions received, go to https:// comment on the proposed collection of Submit written/paper submissions as www.regulations.gov and insert the certain information by the Agency. follows: docket number, found in brackets in the Under the Paperwork Reduction Act of • Mail/Hand Delivery/Courier (for heading of this document, into the 1995 (PRA), Federal Agencies are written/paper submissions): Dockets ‘‘Search’’ box and follow the prompts required to publish notice in the Management Staff (HFA–305), Food and and/or go to the Dockets Management Federal Register concerning each Drug Administration, 5630 Fishers Staff, 5630 Fishers Lane, Rm. 1061, proposed collection of information, Lane, Rm. 1061, Rockville, MD 20852. Rockville, MD 20852, 240–402–7500.

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FOR FURTHER INFORMATION CONTACT: Food and Cosmetic Export Certificate applications that include multiple Domini Bean, Office of Operations, Application Process products. Food and Drug Administration, Three OMB Control Number 0910–0793— All information is entered using White Flint North, 10A–12M, 11601 Extension electronic Forms FDA 3613d, 3613e, Landsdown St., North Bethesda, MD and 3613k and used to evaluate 20852, 301–796–5733, PRAStaff@ Some countries may require certificate requests. The eCATS Module manufacturers of FDA-regulated fda.hhs.gov. is Form 3613k, where 3613e is the products to provide certificates for Certificate of Free Sale (https:// SUPPLEMENTARY INFORMATION: Under the products they wish to export to that www.fda.gov/food/food-export- PRA (44 U.S.C. 3501–3521), Federal country. Accordingly, firms exporting certificates/online-applications-export- Agencies must obtain approval from the products from the United States often certificates-food). All ‘‘forms’’ are Office of Management and Budget ask FDA to provide such a ‘‘certificate.’’ electronic and part of the eCATS or CAP (OMB) for each collection of In many cases, foreign governments are portal accessed via https:// information they conduct or sponsor. seeking official assurance that products www.access.fda.gov. To view exported to their countries can be ‘‘Collection of information’’ is defined representations of the forms, you have marketed in the United States, or that in 44 U.S.C. 3502(3) and 5 CFR to download the instructions, which are they meet specific U.S. requirements. In accessible from the following links: 1320.3(c) and includes Agency requests some cases, review of an FDA export or requirements that members of the https://www.fda.gov/cosmetics/ certificate may be required as part of the cosmetics-exporters/online- public submit reports, keep records, or process to register or import a product provide information to a third party. applications-export-certificates- into another country. An export cosmetics and https://www.fda.gov/ Section 3506(c)(2)(A) of the PRA (44 certificate generally indicates that the U.S.C. 3506(c)(2)(A)) requires Federal food/food-export-certificates/online- particular product is marketed in the applications-export-certificates-food. Agencies to provide a 60-day notice in United States or otherwise eligible for While burden associated with the Federal Register concerning each export and that the particular information collection activities for proposed collection of information, manufacturer has no unresolved export certificates issued for other FDA- including each proposed extension of an enforcement actions pending before, or regulated products is approved under taken by, FDA. existing collection of information, OMB control number 0910–0498, this before submitting the collection to OMB FDA’s Center for Food Safety and Applied Nutrition (CFSAN) issues collection specifically supports export for approval. To comply with this certificates issued by CFSAN. Also, requirement, FDA is publishing notice export certificates for human food and cosmetic products. Interested persons because we have eliminated paper- of the proposed collection of based forms, respondents who require information set forth in this document. may request a certificate electronically via the CFSAN Export Certification assistance with completing export With respect to the following Application and Tracking System certificate applications online may collection of information, FDA invites (CFSAN eCATS) or Certificate contact CFSAN directly by email comments on these topics: (1) Whether Application Process (CAP), components (CFSANExportCertification@ the proposed collection of information of the FDA Industry Systems, or by fda.hhs.gov) or telephone (240–402– is necessary for the proper performance contacting CFSAN for assistance. Health 2307). Instructions for requesting export of FDA’s functions, including whether certificates are the exception and are certificates for cosmetics (Form FDA the information will have practical requested via email. To facilitate the 3613d) are available online at https:// utility; (2) the accuracy of FDA’s application process, we have eliminated www.fda.gov/cosmetics/cosmetics- estimate of the burden of the proposed paper-based forms. For food products, exporters/online-applications-export- certificates-cosmetics and instructions collection of information, including the respondents are able to identify for requesting export certificates for validity of the methodology and facilities using their Food Facility food (Forms FDA 3613e and Form assumptions used; (3) ways to enhance Registration, an FDA Establishment Identifier number, or a Data Universal 3613k) are available online at https:// the quality, utility, and clarity of the www.fda.gov/food/food-export- information to be collected; and (4) Numbering System number. The system uses these identifiers to locate and certificates/online-applications-export- ways to minimize the burden of the autopopulate name and address certificates-food. collection of information on information, eliminating the need for Description of Respondents: The respondents, including through the use users to manually enter this information respondents to this collection of of automated collection techniques, and reducing the time to complete the information are firms interested in when appropriate, and other forms of application. For some applications, exporting U.S.-manufactured human information technology. respondents can also upload product food and cosmetic products to foreign information via a spreadsheet, which countries that require export certificates. reduces the time needed to enter We estimate the burden of this product information, particularly for collection of information as follows:

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Number of Average burden per Type of 2 Number of Total annual respondent Form No. responses per response Total hours respondents respondent responses (in hours)

Cosmetics ...... FDA 3613d ...... 113 3 339 0.5 (30 minutes) ..... 170 Food ...... FDA 3613e, 3613k ...... 468 9 4,212 0.5 (30 minutes) ..... 2,106

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TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued

Type of Number of Number of Total annual Average burden per Form No. 2 responses per response Total hours respondent respondents respondent responses (in hours)

Total ...... 2,276 1 There are no capital costs or operating and maintenance costs associated with this collection of information. 2 All forms are submitted electronically via FDA Industry Systems.

Based on a review of the information Electronic Submissions a.m. and 4 p.m., Monday through collection since our last OMB approval, Friday, 240–402–7500. Submit electronic comments in the • we have reduced our burden estimate. following way: Confidential Submissions—To The burden estimate has been lowered • Federal eRulemaking Portal: submit a comment with confidential due to a reduced number of https://www.regulations.gov. Follow the information that you do not wish to be respondents. We base our estimates on instructions for submitting comments. made publicly available, submit your our experience with certificate Comments submitted electronically, comments only as a written/paper applications received in the past 3 fiscal including attachments, to https:// submission. You should submit two years. www.regulations.gov will be posted to copies total. One copy will include the Dated: March 9, 2021. the docket unchanged. Because your information you claim to be confidential with a heading or cover note that states Lauren K. Roth, comment will be made public, you are solely responsible for ensuring that your ‘‘THIS DOCUMENT CONTAINS Acting Principal Associate Commissioner for CONFIDENTIAL INFORMATION.’’ The Policy. comment does not include any confidential information that you or a Agency will review this copy, including [FR Doc. 2021–05369 Filed 3–15–21; 8:45 am] the claimed confidential information, in BILLING CODE 4164–01–P third party may not wish to be posted, such as medical information, your or its consideration of comments. The anyone else’s Social Security number, or second copy, which will have the DEPARTMENT OF HEALTH AND confidential business information, such claimed confidential information HUMAN SERVICES as a manufacturing process. Please note redacted/blacked out, will be available that if you include your name, contact for public viewing and posted on Food and Drug Administration information, or other information that https://www.regulations.gov. Submit identifies you in the body of your both copies to the Dockets Management [Docket No. FDA–2020–D–0770] comments, that information will be Staff. If you do not wish your name and posted on https://www.regulations.gov. contact information to be made publicly Best Practices in Developing • If you want to submit a comment available, you can provide this Proprietary Names for Human with confidential information that you information on the cover sheet and not Nonprescription Drug Products; Draft do not wish to be made available to the in the body of your comments and you Guidance for Industry; Availability; public, submit the comment as a must identify this information as Reopening of the Comment Period written/paper submission and in the ‘‘confidential.’’ Any information marked as ‘‘confidential’’ will not be disclosed AGENCY: Food and Drug Administration, manner detailed (see ‘‘Written/Paper Submissions’’ and ‘‘Instructions’’). except in accordance with 21 CFR 10.20 HHS. and other applicable disclosure law. For ACTION: Notice of availability; reopening Written/Paper Submissions more information about FDA’s posting of the comment period. Submit written/paper submissions as of comments to public dockets, see 80 follows: FR 56469, September 18, 2015, or access SUMMARY: The Food and Drug • Mail/Hand Delivery/Courier (for the information at: https:// Administration (FDA or Agency) is written/paper submissions): Dockets www.govinfo.gov/content/pkg/FR-2015- reopening the comment period for the Management Staff (HFA–305), Food and 09-18/pdf/2015-23389.pdf. notice entitled ‘‘Best Practices in Drug Administration, 5630 Fishers Docket: For access to the docket to Developing Proprietary Names for Lane, Rm. 1061, Rockville, MD 20852. read background documents or the Human Nonprescription Drug Products; • For written/paper comments electronic and written/paper comments Draft Guidance for Industry; submitted to the Dockets Management received, go to https:// Availability’’ that appeared in the Staff, FDA will post your comment, as www.regulations.gov and insert the Federal Register of December 9, 2020. well as any attachments, except for docket number, found in brackets in the The Agency is taking this action to information submitted, marked and heading of this document, into the allow interested persons additional time identified, as confidential, if submitted ‘‘Search’’ box and follow the prompts to submit comments. as detailed in ‘‘Instructions.’’ and/or go to the Dockets Management DATES: FDA is reopening the comment Instructions: All submissions received Staff, 5630 Fishers Lane, Rm. 1061, period for the notice published on must include the Docket No. FDA– Rockville, MD 20852, 240–402–7500. December 9, 2020 (85 FR 79187). 2020–D–0770 for ‘‘Best Practices in You may submit comments on any Submit either electronic or written Developing Proprietary Names for guidance at any time (see 21 CFR comments on the draft guidance by June Human Nonprescription Drug 10.115(g)(5)). 14, 2021 to ensure that the Agency Products.’’ Received comments will be Submit written requests for single considers your comment on this draft placed in the docket and, except for copies of the draft guidance to the guidance before it begins work on the those submitted as ‘‘Confidential Division of Drug Information, Center for final version of the guidance. Submissions,’’ publicly viewable at Drug Evaluation and Research, Food ADDRESSES: You may submit comments https://www.regulations.gov or at the and Drug Administration, 10001 New on any guidance at any time as follows: Dockets Management Staff between 9 Hampshire Ave., Hillandale Building,

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4th Floor, Silver Spring, MD 20993– DEPARTMENT OF HEALTH AND solely responsible for ensuring that your 0002, or to the Office of HUMAN SERVICES comment does not include any Communication, Outreach and confidential information that you or a Development, Center for Biologics Food and Drug Administration third party may not wish to be posted, Evaluation and Research, Food and [Docket No. FDA–2019–E–1935] such as medical information, your or Drug Administration, 10903 New anyone else’s Social Security number, or Hampshire Ave., Bldg. 71, Rm. 3128, Determination of Regulatory Review confidential business information, such Silver Spring, MD 20993–0002. Send Period for Purposes of Patent as a manufacturing process. Please note one self-addressed adhesive label to Extension; OCS LUNG SYSTEM that if you include your name, contact assist that office in processing your information, or other information that requests. See the SUPPLEMENTARY AGENCY: Food and Drug Administration, identifies you in the body of your INFORMATION section for electronic HHS. comments, that information will be access to the draft guidance document. ACTION: Notice. posted on https://www.regulations.gov. • If you want to submit a comment FOR FURTHER INFORMATION CONTACT: SUMMARY: The Food and Drug with confidential information that you Danielle Harris, Center for Drug Administration (FDA or Agency) has do not wish to be made available to the Evaluation and Research, Food and determined the regulatory review period public, submit the comment as a Drug Administration, 10903 New for OCS LUNG SYSTEM and is written/paper submission and in the Hampshire Ave., Bldg. 22, Rm. 4461, publishing this notice of that manner detailed (see ‘‘Written/Paper Silver Spring, MD 20993–0002, 301– determination as required by law. FDA Submissions’’ and ‘‘Instructions’’). 796–4590; or Stephen Ripley, Center for has made the determination because of Written/Paper Submissions Biologics Evaluation and Research, the submission of an application to the Food and Drug Administration, 10903 Director of the U.S. Patent and Submit written/paper submissions as New Hampshire Ave., Bldg. 71, Rm. Trademark Office (USPTO), Department follows: • 7301, Silver Spring, MD 20993–0002, of Commerce, for the extension of a Mail/Hand Delivery/Courier (for 240–402–7911. patent which claims that medical written/paper submissions): Dockets Management Staff (HFA–305), Food and SUPPLEMENTARY INFORMATION: device. Drug Administration, 5630 Fishers I. Background DATES: Anyone with knowledge that any Lane, Rm. 1061, Rockville, MD 20852. of the dates as published (in the • For written/paper comments In the Federal Register of December 9, SUPPLEMENTARY INFORMATION section) are submitted to the Dockets Management 2020 (85 FR 79187), FDA published a incorrect may submit either electronic Staff, FDA will post your comment, as notice with a 60-day comment period to or written comments and ask for a well as any attachments, except for request comments on the draft guidance redetermination by May 17, 2021. information submitted, marked and for industry entitled ‘‘Best Practices in Furthermore, any interested person may identified, as confidential, if submitted Developing Proprietary Names for petition FDA for a determination as detailed in ‘‘Instructions.’’ Human Nonprescription Drug regarding whether the applicant for Instructions: All submissions received Products.’’ extension acted with due diligence must include the Docket No. FDA– The Agency has received a request for during the regulatory review period by 2019–E–1935 for ‘‘Determination of an extension of the comment period for September 13, 2021. See ‘‘Petitions’’ in Regulatory Review Period for Purposes the draft guidance to ensure that the the SUPPLEMENTARY INFORMATION section of Patent Extension; OCS LUNG Agency considers additional comments for more information. SYSTEM.’’ Received comments, those on the draft guidance before it begins ADDRESSES: You may submit comments filed in a timely manner (see work on the final version of the as follows. Please note that late, ADDRESSES), will be placed in the docket guidance. FDA has considered the untimely filed comments will not be and, except for those submitted as request and is reopening the comment considered. Electronic comments must ‘‘Confidential Submissions,’’ publicly period until June 14, 2021. The Agency be submitted on or before May 17, 2021. viewable at https://www.regulations.gov believes that an additional 90 days will The https://www.regulations.gov or at the Dockets Management Staff allow adequate time for interested electronic filing system will accept between 9 a.m. and 4 p.m., Monday persons to submit comments. comments until 11:59 p.m. Eastern Time through Friday, 240–402–7500. at the end of May 17, 2021. Comments • Confidential Submissions—To II. Electronic Access received by mail/hand delivery/courier submit a comment with confidential Persons with access to the internet (for written/paper submissions) will be information that you do not wish to be may obtain the draft guidance at https:// considered timely if they are made publicly available, submit your www.fda.gov/Drugs/Guidance postmarked or the delivery service comments only as a written/paper ComplianceRegulatoryInformation/ acceptance receipt is on or before that submission. You should submit two Guidances/default.htm, https:// date. copies total. One copy will include the information you claim to be confidential www.fda.gov/vaccines-blood-biologics/ Electronic Submissions guidance-compliance-regulatory- with a heading or cover note that states information-biologics/biologics- Submit electronic comments in the ‘‘THIS DOCUMENT CONTAINS following way: CONFIDENTIAL INFORMATION.’’ The guidances, or https:// • www.regulations.gov. Federal eRulemaking Portal: Agency will review this copy, including https://www.regulations.gov. Follow the the claimed confidential information, in Dated: March 10, 2021. instructions for submitting comments. its consideration of comments. The Lauren K. Roth, Comments submitted electronically, second copy, which will have the Acting Principal Associate Commissioner for including attachments, to https:// claimed confidential information Policy. www.regulations.gov will be posted to redacted/blacked out, will be available [FR Doc. 2021–05323 Filed 3–15–21; 8:45 am] the docket unchanged. Because your for public viewing and posted on BILLING CODE 4164–01–P comment will be made public, you are https://www.regulations.gov. Submit

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both copies to the Dockets Management (for example, half the testing phase must PMA P160013 was submitted on May Staff. If you do not wish your name and be subtracted as well as any time that 23, 2016. contact information to be made publicly may have occurred before the patent 3. The date the application was available, you can provide this was issued), FDA’s determination of the approved: March 22, 2018. FDA has length of a regulatory review period for information on the cover sheet and not verified the applicant’s claim that PMA in the body of your comments and you a medical device will include all of the P160013 was approved on March 22, must identify this information as testing phase and approval phase as 2018. ‘‘confidential.’’ Any information marked specified in 35 U.S.C. 156(g)(3)(B). as ‘‘confidential’’ will not be disclosed FDA has approved for marketing the This determination of the regulatory except in accordance with § 10.20 (21 medical device OCS LUNG SYSTEM. review period establishes the maximum CFR 10.20) and other applicable OCS LUNG SYSTEM is a portable organ potential length of a patent extension. disclosure law. For more information perfusion, ventilation, and monitoring However, the USPTO applies several about FDA’s posting of comments to medical device indicated for the statutory limitations in its calculations public dockets, see 80 FR 56469, preservation of standard criteria donor of the actual period for patent extension. September 18, 2015, or access the lungs in a near physiologic, ventilated, In its application for patent extension, information at: https:// and perfused state for double-lung this applicant seeks 1,687 days of patent www.govinfo.gov/content/pkg/FR-2015- transplantation. Subsequent to this term extension. 09-18/pdf/2015-23389.pdf. approval, the USPTO received a patent Docket: For access to the docket to term restoration application for OCS III. Petitions read background documents or the LUNG SYSTEM (U.S. Patent No. Anyone with knowledge that any of electronic and written/paper comments 6,100,082) from TransMedics, Inc., and the dates as published are incorrect may received, go to https:// the USPTO requested FDA’s assistance www.regulations.gov and insert the in determining this patent’s eligibility submit either electronic or written docket number, found in brackets in the for patent term restoration. In a letter comments and, under 21 CFR 60.24, ask heading of this document, into the dated June 21, 2019, FDA advised the for a redetermination (see DATES). ‘‘Search’’ box and follow the prompts USPTO that this medical device had Furthermore, as specified in § 60.30 (21 and/or go to the Dockets Management undergone a regulatory review period CFR 60.30), any interested person may Staff, 5630 Fishers Lane, Rm. 1061, and that the approval of OCS LUNG petition FDA for a determination Rockville, MD 20852, 240–402–7500. SYSTEM represented the first permitted regarding whether the applicant for commercial marketing or use of the FOR FURTHER INFORMATION CONTACT: extension acted with due diligence product. Thereafter, the USPTO Beverly Friedman, Office of Regulatory during the regulatory review period. To requested that FDA determine the meet its burden, the petition must Policy, Food and Drug Administration, product’s regulatory review period. 10903 New Hampshire Ave., Bldg. 51, comply with all the requirements of Rm. 6250, Silver Spring, MD 20993, II. Determination of Regulatory Review § 60.30, including but not limited to: 301–796–3600. Period Must be timely (see DATES), must be SUPPLEMENTARY INFORMATION: FDA has determined that the filed in accordance with § 10.20, must applicable regulatory review period for contain sufficient facts to merit an FDA I. Background OCS LUNG SYSTEM is 2,341 days. Of investigation, and must certify that a The Drug Price Competition and this time, 1,672 days occurred during true and complete copy of the petition Patent Term Restoration Act of 1984 the testing phase of the regulatory has been served upon the patent (Pub. L. 98–417) and the Generic review period, while 669 days occurred applicant. (See H. Rept. 857, part 1, 98th Animal Drug and Patent Term during the approval phase. These Cong., 2d sess., pp. 41–42, 1984.) Restoration Act (Pub. L. 100–670) periods of time were derived from the Petitions should be in the format generally provide that a patent may be following dates: specified in 21 CFR 10.30. extended for a period of up to 5 years 1. The date an exemption for this Submit petitions electronically to so long as the patented item (human device, under section 520(g) of the https://www.regulations.gov at Docket drug product, animal drug product, Federal Food, Drug, and Cosmetic Act No. FDA–2013–S–0610. Submit written medical device, food additive, or color (FD&C Act) (21 U.S.C. 360j(g)), became petitions (two copies are required) to the additive) was subject to regulatory effective: October 26, 2011. The review by FDA before the item was applicant claims that the investigational Dockets Management Staff (HFA–305), marketed. Under these acts, a product’s device exemption (IDE) required under Food and Drug Administration, 5630 regulatory review period forms the basis section 520(g) of the FD&C Act for Fishers Lane, Rm. 1061, Rockville, MD for determining the amount of extension human tests to begin became effective 20852. an applicant may receive. on March 8, 2012. However, FDA Dated: March 9, 2021. A regulatory review period consists of records indicate that the IDE was Lauren K. Roth, two periods of time: A testing phase and determined substantially complete for Acting Principal Associate Commissioner for an approval phase. For medical devices, clinical studies to have begun on Policy. the testing phase begins with a clinical October 26, 2011, which represents the [FR Doc. 2021–05372 Filed 3–15–21; 8:45 am] investigation of the device and IDE effective date. continues until the approval phase 2. The date an application was BILLING CODE 4164–01–P begins. The approval phase starts with initially submitted with respect to the the initial submission of an application device under section 515 of the FD&C to market the device and continues until Act (21 U.S.C. 360e): May 23, 2016. The permission to market the device is applicant claims April 28, 2016, as the granted. Although only a portion of a date the premarket approval application regulatory review period may count (PMA) for OCS LUNG SYSTEM (PMA toward the actual amount of extension P160013) was initially submitted. that the Director of USPTO may award However, FDA records indicate that

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DEPARTMENT OF HEALTH AND • Federal eRulemaking Portal: the claimed confidential information, in HUMAN SERVICES https://www.regulations.gov. Follow the its consideration of comments. The instructions for submitting comments. second copy, which will have the Food and Drug Administration Comments submitted electronically, claimed confidential information [Docket No. FDA–2021–N–0127] including attachments, to https:// redacted/blacked out, will be available www.regulations.gov will be posted to for public viewing and posted on Potential Medication Error Risks With the docket unchanged. Because your https://www.regulations.gov. Submit Investigational Drug Container Labels; comment will be made public, you are both copies to the Dockets Management Public Meeting; Request for Comments solely responsible for ensuring that your Staff. If you do not wish your name and comment does not include any contact information to be made publicly AGENCY: Food and Drug Administration, confidential information that you or a available, you can provide this HHS. third party may not wish to be posted, information on the cover sheet and not ACTION: Notice of public meeting; such as medical information, your or in the body of your comments and you request for comments. anyone else’s Social Security number, or must identify this information as confidential business information, such ‘‘confidential.’’ Any information marked SUMMARY: The Food and Drug as a manufacturing process. Please note as ‘‘confidential’’ will not be disclosed Administration (FDA, the Agency, or that if you include your name, contact except in accordance with 21 CFR 10.20 we) is announcing the following public information, or other information that and other applicable disclosure law. For meeting entitled ‘‘Potential Medication identifies you in the body of your more information about FDA’s posting Error Risks with Investigational Drug comments, that information will be of comments to public dockets, see 80 Container Labels.’’ This public meeting posted on https://www.regulations.gov. FR 56469, September 18, 2015, or access • is being convened and supported by a If you want to submit a comment the information at: https:// partnership between the Reagan-Udall with confidential information that you www.govinfo.gov/content/pkg/FR-2015- Foundation and FDA. The purpose of do not wish to be made available to the 09-18/pdf/2015-23389.pdf. the public meeting is to solicit input public, submit the comment as a Docket: For access to the docket to from stakeholders (e.g., sponsors, written/paper submission and in the read background documents or the clinical sites, entities that supply or manner detailed (see ‘‘Written/Paper electronic and written/paper comments otherwise label investigational drugs) on Submissions’’ and ‘‘Instructions’’). received, go to https:// the risk of medication errors potentially Written/Paper Submissions www.regulations.gov and insert the related to the content and format of docket number, found in brackets in the Submit written/paper submissions as information on investigational drug heading of this document, into the follows: container labels, the prevalence and ‘‘Search’’ box and follow the prompts • Mail/Hand Delivery/Courier (for nature of such errors, and to gather and/or go to the Dockets Management written/paper submissions): Dockets information on practices that minimize Staff, 5630 Fishers Lane, Rm. 1061, Management Staff (HFA–305), Food and the potential for medication errors. Rockville, MD 20852, 240–402–7500. Drug Administration, 5630 Fishers DATES: The public meeting will be held Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Jo virtually and broadcast via webcast on • For written/paper comments Wyeth, Center for Drug Evaluation and May 18, 2021, from 1 p.m. to 4 p.m. submitted to the Dockets Management Research, Food and Drug (Eastern Time), and May 19, 2021, from Staff, FDA will post your comment, as Administration, 10903 New Hampshire 10 a.m. to 1 p.m. (Eastern Time). Submit well as any attachments, except for Ave., Bldg. 22, Rm. 4326, Silver Spring, either electronic or written comments information submitted, marked and MD 20993, 301–796–1985, Jo.Wyeth@ on this public meeting by June 18, 2021. identified, as confidential, if submitted fda.hhs.gov; or Stephen Ripley, Center See the SUPPLEMENTARY INFORMATION as detailed in ‘‘Instructions.’’ for Biologics Evaluation and Research, section for registration date and Instructions: All submissions received Food and Drug Administration, 10903 information. must include the Docket No. FDA– New Hampshire Ave., Bldg. 71, Rm. ADDRESSES: Please note that due to the 2021–N–0127 for ‘‘Potential Medication 7301, Silver Spring, MD 20993, 240– impact of the COVID–19 pandemic, all Error Risks With Investigational Drug 402–7911. meeting participants will be joining this Container Labels.’’ Received comments, SUPPLEMENTARY INFORMATION: public meeting via an online those filed in a timely manner (see I. Background teleconferencing platform. ADDRESSES), will be placed in the docket You may submit comments as and, except for those submitted as The purpose of the public meeting follows. Please note that late, untimely ‘‘Confidential Submissions,’’ publicly announced in this notice is to solicit filed comments will not be considered. viewable at https://www.regulations.gov input from stakeholders (e.g., sponsors, Electronic comments must be submitted or at the Dockets Management Staff investigators, clinical sites, contract on or before June 18, 2021. The https:// between 9 a.m. and 4 p.m., Monday research organizations and other entities www.regulations.gov electronic filing through Friday, 240–402–7500. that supply or otherwise label system will accept comments until • Confidential Submissions—To investigational drugs, regulators, 11:59 p.m. Eastern Time at the end of submit a comment with confidential professional organizations, and study June 18, 2021. Comments received by information that you do not wish to be participants) on the risk of medication mail/hand delivery/courier (for written/ made publicly available, submit your errors potentially related to the content paper submissions) will be considered comments only as a written/paper and format of the information on timely if they are postmarked or the submission. You should submit two investigational drug container labels, delivery service acceptance receipt is on copies total. One copy will include the the prevalence and nature of such or before that date. information you claim to be confidential errors, and to gather information on with a heading or cover note that states practices that minimize the potential for Electronic Submissions ‘‘THIS DOCUMENT CONTAINS medication errors. Submit electronic comments in the CONFIDENTIAL INFORMATION.’’ The For the purpose of this meeting, an following way: Agency will review this copy, including investigational drug means a drug or

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biological product that is used in a sponsor address, or storage conditions) information on investigational drug clinical investigation under an (Ref. 5). The study also found other container labels include: (1) The investigational new drug application. factors that may contribute to prevalence and types of medication FDA definitions and requirements medication errors, including the use of errors attributed to container labels; (2) related to investigational new drug small font sizes (less than 8 point), the impact of such errors on clinical applications are provided in 21 CFR variable formats for expiration dates and investigations; (3) information that part 312. The requirements for labeling lot numbers, the presence of error-prone should always be on the container label, an investigational new drug include: (1) abbreviations, limited use of color or and how that information should be The immediate package of an other differentiation techniques, and presented to facilitate safe use; (4) investigational new drug intended for highly similar product or protocol entities responsible for labeling human use shall bear a label with the identification numbers (Ref. 5). A containers; (5) existing processes for statement ‘‘Caution: New Drug—Limited French simulation study using reporting and analyzing medication by Federal (or United States) law to investigational drug container labels errors and complaints related to investigational use’’ and (2) the label or found an error rate of approximately 12 container labels; and (6) global labeling of an investigational new drug percent (most errors were related to regulatory convergence and differences shall not bear any statement that is false dosage unit, trial code, drug confusion, for the information on container labels. or misleading in any particular and or expiration date) (Ref. 6). III. Participating in the Public Meeting shall not represent that the Best practice guidelines, such as those investigational new drug is safe or released by the American Society of Registration: To register for the public effective for the purposes for which it is Health System Pharmacists, have meeting, complete the registration form being investigated (21 CFR 312.6). recommended specific content and at https://reaganudall.org/news-and- While not a regulatory requirement, format for investigational drug container events/events/investigational-drug- some investigational new drug container labels (Ref. 7). In 2018, the Institute for labels. Please provide complete contact labels may include additional Safe Medication Practices (ISMP) information for each attendee, including information such as the protocol/ published two reports on medication name, title, affiliation, address, email, clinical trial number, concentration error risks with investigational drugs and telephone number. Registration is and/or strength, dosage form (e.g., (Refs. 8 and 9). The first report free. tablets, injection), quantity per (published in April 2018) explored If you need special accommodations container, storage requirements, and lot reported risks with investigational drug due to a disability, please contact Jo number. Sponsors of an investigational nomenclature, labeling, and packaging, Wyeth (see FOR FURTHER INFORMATION new drug application are required to which included unlabeled containers CONTACT) no later than May 5, 2021. report to FDA any suspected adverse and look-alike product identifiers, Requests for Oral Presentations: reaction that is both serious and confusing or missing information (e.g., During online registration you may unexpected (21 CFR 312.32(c)(1)(i)) 1. container labels missing, route of indicate if you wish to present during a Adverse reactions that are not serious or administration, dosage form, or net public comment session or participate unexpected or medication errors that do quantity) to support safe use, small in a specific session, and which topic(s) not result in adverse reactions may be unreadable text, and the use of codes you wish to address. We will do our reported in the annual report, or not and error-prone abbreviations on best to accommodate requests to make reported at all. FDA is aware that container labels (Ref. 9). The second public comments and requests to globally, other regulatory agencies have report (published in May 2018) participate in the focused sessions. varying requirements related to recommended error mitigation strategies Individuals and organizations with investigational drug labeling and safety for clinical sites, sponsors, and other common interests are urged to reporting (Refs. 1 to 3). entities that supply investigational consolidate or coordinate their The incidence and scope (e.g., error drugs and included the presentations, and request time for a type; stage in the medication use system recommendation to standardize the joint presentation, or submit requests for where the error occurred; actual, or content and format of information on designated representatives to participate potential for, adverse events; reporting investigational drug container labels in the focused sessions. All requests to practices) of medication errors (Ref. 8). make oral presentations must be associated with investigational drugs is FDA reviewed additional reports of received by April 28, 2021. We will unknown. FDA recognizes that clinical medication error concerns related to determine the amount of time allotted to research is conducted globally (Ref. 4). unlabeled or poorly labeled each presenter and the approximate Published literature from outside the investigational drug container labels time each oral presentation is to begin, United States has pointed to the (Refs. 10 to 13). The design of container and will select and notify participants container labels as a contributing factor labels can impact the ability of by May 3, 2021. If selected for for potential medication errors with healthcare providers to readily locate presentation, any presentation materials investigational drugs and recommended and understand critical information for must be emailed to Jo Wyeth (see FOR global harmonization of the information product use (Ref. 14), which in turn may FURTHER INFORMATION CONTACT) no later on the labels (Refs. 5 and 6). For threaten the integrity of clinical than May 10, 2021. No commercial or example, a Canadian study that investigations and impact the safety and promotional material will be permitted included labels from blinded protocols protection of subjects who participate in to be presented or distributed at the provided by European and American these investigations. public meeting. sponsors found almost half of the labels Streaming Webcast of the Public II. Topics for Discussion at the Public Meeting: This public meeting will be affixed to investigational drug Meeting containers were missing important webcast. Persons interested in During the public meeting, speakers information (usually the expiration date, participating in the webcast are and participants will cover a range of encouraged to register in advance (see 1 Sponsors have additional investigational new issues related to medication errors and Registration). The webcast will also be drug safety reporting requirements that may apply investigational drugs. Discussion topics available on the day of the event (see 21 CFR 312.32(c)(1)(ii) through (iv)). related to the format and content of without preregistration. Detailed

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information for participating in the services/drugs-health-products/ medication-errors). When final, this webcast is available at the following compliance-enforcement/good-clinical- guidance will represent the FDA’s website: https://reaganudall.org/news- practices/guidance-documents/annex- current thinking on this topic. For the and-events/events/investigational-drug- 13-good-manufacturing-practices- most recent version of a guidance, check guidelines-drugs-clinical-trials- the FDA guidance web page at https:// labels. 0036.html#a8_7). www.fda.gov/regulatory-information/ Registered participants will be sent * 4. FDA, Guidance for Industry and FDA search-fda-guidance-documents. technical system requirements in staff, ‘‘FDA Acceptance of Foreign Dated: March 11, 2021. advance of the event. It is recommended Clinical Studies Not Conducted Under that you review these technical system an IND; Frequently Asked Questions,’’ Lauren K. Roth, requirements before joining the March 2012 (available at https:// Acting Principal Associate Commissioner for streaming web conference of the public www.fda.gov/media/83209/download). Policy. meeting. For the most recent version of a [FR Doc. 2021–05370 Filed 3–15–21; 8:45 am] guidance, check the FDA guidance web BILLING CODE 4164–01–P FDA has verified the website page at https://www.fda.gov/regulatory- addresses in this document, as of the information/search-fda-guidance- date this document publishes in the documents. Federal Register, but websites are 5. Duhamel, A., M. Thibault, D. Lebel, et al., DEPARTMENT OF HEALTH AND subject to change over time. ‘‘Investigational Drug Labeling HUMAN SERVICES Transcripts: Please be advised that as Variability,’’ Clinical Trials, vol. 16(2), Health Resources and Services soon as a transcript of the public pp. 204–213, 2019. Administration meeting is available, it will be accessible 6. Dollinger, C., V. Schwiertz, L. Sarfati, et al., ‘‘SIMulation of Medication Error at https://www.regulations.gov. It may Induced by Clinical Trial Drug Labeling: National Vaccine Injury Compensation be viewed at the Dockets Management The SIMME–CT Study,’’ International Program; List of Petitions Received Staff (see ADDRESSES). A link to the Journal for Quality in Health Care, vol. transcript will also be available on the 28(3), pp. 311–315, 2016. AGENCY: Health Resources and Services internet at https://reaganudall.org/news- 7. Kay, S.C., D.G. Luke, and H.R. Tamer, Administration (HRSA), Department of and-events/events/investigational-drug- ‘‘ASHP Guidelines for the Management Health and Human Services (HHS). labels. of Investigational Drug Products,’’ ACTION: Notice. American Journal of Health-System IV. References Pharmacy, vol. 75(8), pp. 561–573, 2018. SUMMARY: HRSA is publishing this The following references marked with * 8. ISMP, ‘‘Investigational Drugs: Strategies notice of petitions received under the for Sponsors, FDA, and Clinical Sites to an asterisk (*) are on display at the National Vaccine Injury Compensation Prevent Product-Related Errors (Part II),’’ Program (the Program), as required by Dockets Management Staff (see Public release date: May 3, 2018 (available ADDRESSES) and are available for at https://www.ismp.org/resources/ the Public Health Service (PHS) Act, as viewing by interested persons between investigational-drugs-strategies-sponsors- amended. While the Secretary of HHS is 9 a.m. and 4 p.m., Monday through fda-and-clinical-sites-prevent-product- named as the respondent in all Friday; they also are available related). proceedings brought by the filing of electronically at https:// * 9. ISMP, ‘‘Investigational Drugs: Product- petitions for compensation under the www.regulations.gov. References Related Issues Pose Significant Program, the United States Court of without asterisks are not on public Challenges (Part I),’’ Public release date: Federal Claims is charged by statute April 19, 2018 (available at https:// display at https://www.regulations.gov with responsibility for considering and www.ismp.org/resources/investigational- acting upon the petitions. because they have copyright restriction. drugs-product-related-issues-pose- Some may be available at the website significant-challenges-part-i). FOR FURTHER INFORMATION CONTACT: For address, if listed. References without 10. Cruz, J.L. and J.N. Brown, ‘‘Safety Risks information about requirements for asterisks are available for viewing only With Investigational Drugs: Pharmacy filing petitions, and the Program in at the Dockets Management Staff. FDA Practices and Perceptions in the Veterans general, contact Lisa L. Reyes, Clerk of has verified the website addresses, as of Affairs Health System,’’ Therapeutic Court, United States Court of Federal the date this document publishes in the Advances in Drug Safety, vol. 6(3), pp. Claims, 717 Madison Place NW, Federal Register, but websites are 103–109, 2015. Washington, DC 20005, (202) 357–6400. 11. Grissinger, M., ‘‘Reducing the Potential For information on HRSA’s role in the subject to change over time. for Mistakes With Investigational Drugs,’’ * 1. European Commission, ‘‘EU Guidelines Pharmacy and Therapeutics, vol. 36(3), Program, contact the Director, National to Good Manufacturing Practice; pp. 120–138, 2011. Vaccine Injury Compensation Program, Medicinal Products for Human and 12. Brown, J.N., S.R. Britnell, A.P. Stivers, et 5600 Fishers Lane, Room 08N146B, Veterinary Use,’’ Public release date: al., ‘‘Medication Safety in Clinical Trials: Rockville, Maryland 20857; (301) 443– February 3, 2010 (available at https:// Role of the Pharmacist in Optimizing 6593, or visit our website at: http:// ec.europa.eu/health/sites/health/files/ Practice, Collaboration, and Education www.hrsa.gov/vaccinecompensation/ files/eudralex/vol-4/2009_06_ To Reduce Errors,’’ Yale Journal of index.html. annex13.pdf). Biology and Medicine, vol. 90(1), pp. 2. Smith-Gick, J., N. Barnes, R. Barone, et al., 125–133, 2017. SUPPLEMENTARY INFORMATION: The ‘‘The Near-Term Viability and Benefits of * 13. ISMP, ‘‘Remdesivir Investigational Drug Program provides a system of no-fault eLabels for Patients, Clinical Sites, and Labeling Confusion,’’ Acute Care, vol. compensation for certain individuals Sponsors,’’ Therapeutic Innovation and 25(9), 2020. who have been injured by specified Regulatory Science, vol. 52(5), pp. 537– * 14. FDA, Draft Guidance for Industry, childhood vaccines. Subtitle 2 of Title 545, 2018. ‘‘Safety Considerations for Container XXI of the PHS Act, 42 U.S.C. 300aa– * 3. Health Canada, Good Clinical Practices Labels and Carton Labeling Design to 10 et seq., provides that those seeking Guidance Document, ‘‘Annex 13 to the Minimize Medication Errors,’’ April Current Edition of the Good 2013 (available at https://www.fda.gov/ compensation are to file a petition with Manufacturing Practices Guidelines regulatory-information/search-fda- the United States Court of Federal Drugs Used in Clinical Trials,’’ August 7, guidance-documents/safety- Claims and to serve a copy of the 2009 (available at https:// considerations-container-labels-and- petition to the Secretary of HHS, who is www.canada.ca/en/health-canada/ carton-labeling-design-minimize- named as the respondent in each

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proceeding. The Secretary has delegated significant aggravation of which did not Claims No: 21–0845V this responsibility under the Program to occur within the time period set forth in 17. Kimberly Albury, Tampa, , Court HRSA. The Court is directed by statute the Table but which was caused by a of Federal Claims No: 21–0846V to appoint special masters who take vaccine’’ referred to in the Table. 18. Oscar Garner, Milwaukee, Wisconsin, Court of Federal Claims No: 21–0847V evidence, conduct hearings as In accordance with Section 19. Phillip Herrera, Milwaukee, Wisconsin, appropriate, and make initial decisions 2112(b)(2), all interested persons may Court of Federal Claims No: 21–0849V as to eligibility for, and amount of, submit written information relevant to 20. Ivan Boyd, Boston, , Court compensation. the issues described above in the case of of Federal Claims No: 21–0850V A petition may be filed with respect the petitions listed below. Any person 21. James D. Woodcock, Greenfield, Indiana, to injuries, disabilities, illnesses, choosing to do so should file an original Court of Federal Claims No: 21–0851V conditions, and deaths resulting from and three (3) copies of the information 22. Rosalind Paaswell, Boston, vaccines described in the Vaccine Injury with the Clerk of the United States Massachusetts, Court of Federal Claims Table (the Table) set forth at 42 CFR Court of Federal Claims at the address No: 21–0853V 100.3. This Table lists for each covered 23. Virginia McGee, Boston, Massachusetts, listed above (under the heading ‘‘For Court of Federal Claims No: 21–0854V childhood vaccine the conditions that Further Information Contact’’), with a 24. Beverly Dye, Newtown, Pennsylvania, may lead to compensation and, for each copy to HRSA addressed to Director, Court of Federal Claims No: 21–0855V condition, the time period for Division of Injury Compensation 25. Yolanda Henderson, Dresher, occurrence of the first symptom or Programs, Healthcare Systems Bureau, Pennsylvania, Court of Federal Claims manifestation of onset or of significant 5600 Fishers Lane, 08N146B, Rockville, No: 21–0857V aggravation after vaccine Maryland 20857. The Court’s caption 26. Anna Miller and Matthew Miller on administration. Compensation may also (Petitioner’s Name v. Secretary of HHS) behalf of A. M., San Diego, California, Court of Federal Claims No: 21–0858V be awarded for conditions not listed in and the docket number assigned to the the Table and for conditions that are 27. Alexis Lainez on behalf of Noah Greyson petition should be used as the caption Montoya, Deceased, Apple Valley, manifested outside the time periods for the written submission. Chapter 35 California, Court of Federal Claims No: specified in the Table, but only if the of title 44, United States Code, related 21–0859V petitioner shows that the condition was to paperwork reduction, does not apply 28. Celeste Bodenbender, Washington, caused by one of the listed vaccines. to information required for purposes of District of Columbia, Court of Federal Section 2112(b)(2) of the PHS Act, 42 carrying out the Program. Claims No: 21–0860V U.S.C. 300aa–12(b)(2), requires that 29. Phyllis K. Alexander, Greensboro, North ‘‘[w]ithin 30 days after the Secretary Diana Espinosa, Carolina, Court of Federal Claims No: receives service of any petition filed Acting Administrator. 21–0861V 30. Adelyn Diaz De La Rocha, Washington, under section 2111 the Secretary shall List of Petitions Filed publish notice of such petition in the District of Columbia, Court of Federal Claims No: 21–0862V Federal Register.’’ Set forth below is a 1. Makaylah Kelly, Englewood, Colorado Court of Federal Claims No: 21–0827V 31. Ana Rivera Rodriguez, San Juan, Puerto list of petitions received by HRSA on Rico, Court of Federal Claims No: 21– February 1, 2021, through February 28, 2. Evelyn Ashford, Washington, District of Columbia, Court of Federal Claims No: 0865V 2021. This list provides the name of 21–0828V 32. Naomi DeLeon on behalf of N. R., Austin, petitioner, city and state of vaccination 3. David K. McQuinn, Washington, District of Texas, Court of Federal Claims No: 21– (if unknown then city and state of Columbia, Court of Federal Claims No: 0866V person or attorney filing claim), and 21–0829V 33. Allen Bickel, Boston, Massachusetts, case number. In cases where the Court 4. Laura O’Hara, Spring, Texas, Court of Court of Federal Claims No: 21–0867V has redacted the name of a petitioner Federal Claims No: 21–0830V 34. Darlene Cucinotta, Clermont, Florida, Court of Federal Claims No: 21–0868V and/or the case number, the list reflects 5. Peter Weil, Madison, Wisconsin, Court of Federal Claims No: 21–0831V 35. Dawn Maxfield, Palm Bay, Florida, Court such redaction. of Federal Claims No: 21–0869V Section 2112(b)(2) also provides that 6. Lisa Carter, Woodbridge, Virginia, Court of Federal Claims No: 21–0832V 36. Dominick Vanore, Reno, Nevada, Court of the special master ‘‘shall afford all 7. Laurie Marowski on behalf of A. M., Federal Claims No: 21–0870V interested persons an opportunity to Phoenix, Arizona, Court of Federal 37. Michelle Mason, Pompano Beach, submit relevant, written information’’ Claims No: 21–0834V Florida, Court of Federal Claims No: 21– relating to the following: 8. Jason Gaskin and Tabitha Gaskin on behalf 0871V 1. The existence of evidence ‘‘that of Jason Gaskin, Jr., Deceased, Rancho 38. David Titus, Washington, District of there is not a preponderance of the Santa Margarita, California, Court of Columbia, Court of Federal Claims No: evidence that the illness, disability, Federal Claims No: 21–0835V 21–0875V injury, condition, or death described in 9. Laurie Blake, Washington, District of 39. Mike Rodriguez, Las Vegas, Nevada, Columbia, Court of Federal Claims No: Court of Federal Claims No: 21–0876V the petition is due to factors unrelated 21–0837V 40. Jerry D. Keller, Richmond, Kentucky, to the administration of the vaccine 10. Jason Groves, Port Angeles, Washington, Court of Federal Claims No: 21–0879V described in the petition,’’ and Court of Federal Claims No: 21–0838V 41. Gina Schueler, Richmond, Kentucky, 2. Any allegation in a petition that the 11. Denise Oldoni, Augusta, Georgia, Court of Court of Federal Claims No: 21–0880V petitioner either: Federal Claims No: 21–0839V 42. Zehra Rizvi, Irmo, South Carolina, Court a. ‘‘[S]ustained, or had significantly 12. Tony Moye, Madisonville, Texas, Court of of Federal Claims No: 21–0881V aggravated, any illness, disability, Federal Claims No: 21–0841V 43. Douglas Arricale, Phoenix, Arizona, Court injury, or condition not set forth in the 13. Hema Mullur, Austin, Texas, Court of of Federal Claims No: 21–0882V Vaccine Injury Table but which was Federal Claims No: 21–0842V 44. Graham Wilkinson, Washington, District caused by’’ one of the vaccines referred 14. Barbara Langburt, Washington, District of of Columbia, Court of Federal Claims No: Columbia, Court of Federal Claims No: 21–0883V to in the Table, or 21–0843V 45. Sherry Jeffries Compton on behalf of b. ‘‘[S]ustained, or had significantly 15. Paul Longo, Washington, District of Joyce E. Jeffries, Memphis, , aggravated, any illness, disability, Columbia, Court of Federal Claims No: Court of Federal Claims No: 21–0884V injury, or condition set forth in the 21–0844V 46. Dennis Franklin, Springfield, Minnesota, Vaccine Injury Table the first symptom 16. Joseph Ned Martinez, Washington, Court of Federal Claims No: 21–0885V or manifestation of the onset or District of Columbia, Court of Federal 47. Emilia Ostrowska, Houston, Texas, Court

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of Federal Claims No: 21–0886V Oklahoma City, Oklahoma, Court of Federal Claims No: 21–0971V 48. Krystal Layman, Chillicothe, , Court Federal Claims No: 21–0934V 113. Kathaleen Lang, Dallas, Texas, Court of of Federal Claims No: 21–0887V 81. Katherine O’Brien, Tinton Falls, New Federal Claims No: 21–0972V 49. Margaret Craig, Madisonville, Texas, Jersey, Court of Federal Claims No: 21– 114. Ulrike Mathilde Mueller-Sprout, Dallas, Court of Federal Claims No: 21–0889V 0936V Texas, Court of Federal Claims No: 21– 50. Paul Bishop, Rochester, New York, Court 82. Robert Willis, Bluffton, South Carolina, 0973V of Federal Claims No: 21–0891V Court of Federal Claims No: 21–0938V 51. Abraham Scott, Flowood, Mississippi, 83. Es Mae Rose, Pendleton, Oregon, Court of 115. Sandra Camacho, Dallas, Texas, Court of Court of Federal Claims No: 21–0892V Federal Claims No: 21–0939V Federal Claims No: 21–0974V 52. Frank Mares, West Covina, California, 84. Jeannie Lowery, Greensboro, North 116. Andres Visconde, Washington, District Court of Federal Claims No: 21–0893V Carolina, Court of Federal Claims No: of Columbia, Court of Federal Claims No: 53. Kathleen G. McKenna, Spokane, 21–0940V 21–0977V Wisconsin, Court of Federal Claims No: 85. Gwendolyn Pilgrim, Washington, District 117. Liza Orban, Utica, Michigan, Court of 21–0895V of Columbia, Court of Federal Claims No: Federal Claims No: 21–0978V 54. Arlene Bourne, Washington, District of 21–0941V 118. Kimberly Axelrod, Arlington, Virginia, Columbia, Court of Federal Claims No: 86. Vienna Giglio, Eastchester, New York, Court of Federal Claims No: 21–0980V 21–0899V Court of Federal Claims No: 21–0942V 119. Yazmin Soto, New York, New York, 55. Della McKeehan, Collierville, Tennessee, 87. James Russell, Allen Park, Michigan, Court of Federal Claims No: 21–0900V Court of Federal Claims No: 21–0943V Court of Federal Claims No: 21–0981V 56. Margot Meissner, Boston, Massachusetts, 88. Sharon Dewyea, Washington, District of 120. Chih-Jung Chen, Rochester, New York, Court of Federal Claims No: 21–0901V Columbia, Court of Federal Claims No: Court of Federal Claims No: 21–0982V 57. Ingraham Hanahan, Washington, District 21–0944V 121. Kevin Lange, Buffalo, New York, Court of Columbia, Court of Federal Claims No: 89. Justin Hock, Baltimore, Maryland, Court of Federal Claims No: 21–0983V 21–0902V of Federal Claims No: 21–0945V 122. Jillian C. Beccia, Farmington Hills, 58. Brandy Romeo, Dresher, Pennsylvania, 90. Clemmie L. Johnson, Boscobel, Michigan, Court of Federal Claims No: Court of Federal Claims No: 21–0903V Wisconsin, Court of Federal Claims No: 21–0984V 59. Muhand Haddad, Downers Grove, 21–0946V 123. Pamela Clemente, Pittsburgh, 91. Antonio J. Smith, Boscobel, Wisconsin, Illinois, Court of Federal Claims No: 21– Pensylvania, Court of Federal Claims No: 0904V Court of Federal Claims No: 21–0947V 21–0985V 60. Samantha Brotman, New York, New 92. James Cantafio, Danbury, Connecticut, York, Court of Federal Claims No: 21– Court of Federal Claims No: 21–0948V 124. John W. Vance, Conway, Arkansas, 0905V 93. Emma Fox, Exton, Pennsylvania, Court of Court of Federal Claims No: 21–0986V 61. Carol Cabral, Girard, Pennsylvania, Court Federal Claims No: 21–0949V 125. Teresa Scarborough, Tustin, California, of Federal Claims No: 21–0906V 94. Tammy Bosford, Queensbury, New York, Court of Federal Claims No: 21–0987V 62. Sandra Williams, Woodbridge, Virginia, Court of Federal Claims No: 21–0950V 126. Wolfgang R. Moenig and Martina Court of Federal Claims No: 21–0907V 95. Thom Demicco, Loma Linda, California, Moenig on behalf of M. M., Farmington 63. Patricia Merrill, Charlotte, North Court of Federal Claims No: 21–0951V Hills, Michigan, Court of Federal Claims Carolina, Court of Federal Claims No: 96. Debra White, Pacific Grove, California, No: 21–0993V 21–0908V Court of Federal Claims No: 21–0952V 127. Steve Marshall, Englewood, New Jersey, 64. Brenda White, North Lincoln, Kansas, 97. Tremayne D. Edwards, Milwaukee, Court of Federal Claims No: 21–0997V Court of Federal Claims No: 21–0909V Wisconsin, Court of Federal Claims No: 128. Esperanza Perez, Englewood, New 65. Jennifer Hamilton, Memphis, Tennessee, 21–0954V Court of Federal Claims No: 21–0910V 98. Debra Law, St. Louis, Missouri, Court of Jersey, Court of Federal Claims No: 21– 66. Kayla Brown, Chesapeake, Virginia, Court Federal Claims No: 21–0956V 0998V of Federal Claims No: 21–0912V 99. Isaiah Jacobs, Scottsdale, Arizona, Court 129. Lacy Cloud, Cheyenne, Wyoming, Court 67. Barbara Kelly, Gainesville, Georgia, Court of Federal Claims No: 21–0957V of Federal Claims No: 21–0999V of Federal Claims No: 2, Colleen Marie 100. Glorianna Rennish, Sheboygan, 130. Ashley Parmer, Phoenix, Arizona, Court Medlock, Hillsboro, Oregon, Court of Wisconsin, Court of Federal Claims No: of Federal Claims No: 21–1000V Federal Claims No: 21–0915V 21–0959V 131. Brenna Benjamin on behalf of L. J. R., 69. Diane Blouin, Boston, Massachusetts, 101. Jeffrey Flynn, Sunnyside, New York, Ellicott City, Maryland, Court of Federal Court of Federal Claims No: 21–0919V Court of Federal Claims No: 21–0960V Claims No: 21–1001V 70. Amy Lalla, Cortland, New York, Court of 102. Steven Marshall, Ruckersville, Virginia, 132. Jillian Fishburn, Phoenix, Arizona, Federal Claims No: 21–0920V Court of Federal Claims No: 21–0961V Court of Federal Claims No: 21–1002V 71. Michael R. Lueck, Greenfield, Wisconsin, 103. Margaret Spencer, Washington, District Court of Federal Claims No: 21–0923V of Columbia, Court of Federal Claims No: 133. Evelyn Gonzalez, Woodbridge, Illinois, 72. Christian M. Gatto, Linwood, New Jersey, 21–0962V Court of Federal Claims No: 21–1003V Court of Federal Claims No: 21–0924V 104. Elizabeth Fagan, Beverly Hills, 134. Aryel Vezzose, Phoenix, Arizona, Court 73. Juan F. Ruiz, Jr., Boscobel, Wisconsin, California, Court of Federal Claims No: of Federal Claims No: 21–1004V Court of Federal Claims No: 21–0927V 21–0963V 135. Beverly Williams, Richardson, Texas, 74. Carissa Fetters, Phoenix, Arizona, Court 105. Nancy Stolze, Beverly Hills, California, Court of Federal Claims No: 21–1006V of Federal Claims No: 21–0928V Court of Federal Claims No: 21–0964V [FR Doc. 2021–05350 Filed 3–15–21; 8:45 am] 75. Amy Congilose, Matthews, North 106. Andera Smith, Beverly Hills, California, Carolina, Court of Federal Claims No: Court of Federal Claims No: 21–0965V BILLING CODE 4165–15–P 21–0929V 107. Thomas K. O’Connor, New York, New 76. Jennifer Kane, Boalsburg, Pennsylvania, York, Court of Federal Claims No: 21– Court of Federal Claims No: 21–0930V 0966V 77. Marc Clodfelter, Washington, District of 108. Alberto S. Galvan, Waupun, Wisconsin, Columbia, Court of Federal Claims No: Court of Federal Claims No: 21–0967V 21–0931V 109. Felicia Sanchez, Dallas, Texas, Court of 78. Hawke M. Strickland, Waupin, Federal Claims No: 21–0968V Wisconsin, Court of Federal Claims No: 110. Jacqueline Clancy, Ellicott City, 21–0932V Maryland, Court of Federal Claims No: 79. Kimberly A. MacFeggan, Collierville, 21–0969V Tennessee, Court of Federal Claims No: 111. Magdalena Fernandez, Dallas, Texas, 21–0933V Court of Federal Claims No: 21–0970V 80. Claudia Garcia on behalf of G. G., 112. Todd Katz, Dallas, Texas, Court of

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DEPARTMENT OF HEALTH AND ‘‘Currently under Review—Open for Focus groups may also be used to gain HUMAN SERVICES Public Comments’’ or by using the partner input that will inform the design search function. of mail, electronic and/or telephone Health Resources and Services FOR FURTHER INFORMATION CONTACT: To surveys. Focus groups, in-class Administration request a copy of the clearance requests evaluation forms, mail surveys, submitted to OMB for review, email Lisa electronic surveys, and telephone Agency Information Collection surveys are expected to be the preferred Activities: Submission to OMB for Wright-Solomon, the HRSA Information Collection Clearance Officer at data collection methods for this Review and Approval; Public Comment information collection. Request; Voluntary Partner Surveys To [email protected] or call (301) 443– A generic approval allows HRSA to Implement Executive Order 12862 in 1984. conduct a limited number of partner the Health Resources and Services SUPPLEMENTARY INFORMATION: surveys without a full-scale OMB Administration Information Collection Request Title: Voluntary Partner Surveys to Implement review of each survey. If this generic AGENCY: Health Resources and Services Executive Order 12862 in the Health information collection request receives Administration (HRSA), Department of Resources and Services Administration, continued approval, information on Health and Human Services. OMB No. 0915–0212—Extension. each individual partner survey will not ACTION: Notice. Abstract: In response to Executive be published in the Federal Register. Order 12862, HRSA is proposing to A 60-day notice published in the SUMMARY: In compliance with the conduct voluntary customer surveys of Federal Register on December 15, 2020, Paperwork Reduction Act of 1995, its partners to assess strengths and vol. 85, No. 241; pp. 81210–11. There HRSA submitted an Information weaknesses in program services and were no public comments. Collection Request (ICR) to the Office of processes. HRSA partners are typically Burden Statement: Burden in this Management and Budget (OMB) for state or local governments, health care context means the time expended by review and approval. Comments facilities, health care consortia, health persons to generate, maintain, retain, submitted during the first public review care providers, and researchers. HRSA disclose, or provide the information of this ICR will be provided to OMB. is requesting continued approval of a requested. This includes the time OMB will accept further comments from generic clearance from OMB to conduct needed to review instructions; to the public during the review and the partner surveys. develop, acquire, install and utilize approval period. OMB may act on Partner surveys to be conducted by technology and systems for the purpose HRSA’s ICR only after the 30 day HRSA might include, for example, mail, of collecting, validating and verifying comment period for this notice has electronic, and/or telephone surveys of information, processing and closed. grantees to determine satisfaction with maintaining information, and disclosing DATES: Comments on this ICR should be grant processes or technical assistance and providing information; to train received no later than April 15, 2021. provided by a contractor, or in-class or personnel and to be able to respond to ADDRESSES: Written comments and virtual evaluation forms completed by a collection of information; to search recommendations for the proposed providers who receive training from data sources; to complete and review information collection should be sent HRSA grantees to measure satisfaction the collection of information; and to within 30 days of publication of this with the training experience. Results of transmit or otherwise disclose the notice to www.reginfo.gov/public/do/ these surveys will be used to plan and information. The total annual burden PRAMain. Find this particular redirect resources and efforts as needed hours estimated for this ICR are information collection by selecting to improve services and processes. summarized in the table below.

TOTAL ESTIMATED ANNUALIZED BURDEN—HOURS

Average Number of Number of Total burden per Total burden Form name respondents responses per responses response hours respondent (in hours)

In-class evaluations ...... 40,000 1 40,000 .05 2,000 Mail/Telephone surveys ...... 12,000 1 12,000 .25 3,000 Focus groups ...... 250 1 250 1.50 375

Total ...... 52,250 ...... 52,250 ...... 5,375

HRSA specifically requests comments technology to minimize the information DEPARTMENT OF HEALTH AND on (1) the necessity and utility of the collection burden. HUMAN SERVICES proposed information collection for the Maria G. Button, proper performance of the agency’s Office of the Secretary functions, (2) the accuracy of the Director, Executive Secretariat. estimated burden, (3) ways to enhance [FR Doc. 2021–05349 Filed 3–15–21; 8:45 am] Seventh Amendment to Declaration the quality, utility, and clarity of the BILLING CODE 4165–15–P Under the Public Readiness and information to be collected, and (4) the Emergency Preparedness Act for use of automated collection techniques Medical Countermeasures Against or other forms of information COVID–19

ACTION: Notice of amendment.

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SUMMARY: The Acting Secretary issues 2020, October 23, 2020, and January 21, February 16, 2021, the Acting Secretary this amendment pursuant to section 2021. amended the Declaration to add 319F–3 of the Public Health Service Act On March 10, 2020, former Secretary additional categories of Qualified to add additional categories of Qualified Azar issued a Declaration under the Persons authorized to prescribe, Persons authorized to prescribe, PREP Act for medical countermeasures dispense, and administer COVID–19 dispense, and administer covered against COVID–19 (85 FR 15198, Mar. vaccines that are covered countermeasures under section VI of 17, 2020) (the Declaration). On April 10, countermeasures under the Declaration this Declaration. the former Secretary amended the (86 FR 9516, February 16, 2021) and on February 22, 2021, the Department filed DATES: This amendment to the Declaration under the PREP Act to Declaration is effective as of March 11, extend liability immunity to covered a notice of correction to the February 2 2021. countermeasures authorized under the and February 16 notices correcting CARES Act (85 FR 21012, Apr. 15, effective dates stated in the Declaration, FOR FURTHER INFORMATION CONTACT: L. and correcting the description of Paige Ezernack, Office of the Assistant 2020). On June 4, the former Secretary amended the Declaration to clarify that qualified persons added by the February Secretary for Preparedness and 16, 2021 amendment. (86 FR 10588, Response, Office of the Secretary, covered countermeasures under the Declaration include qualified February 22, 2021). Department of Health and Human The Acting Secretary now amends Services, 200 Independence Avenue countermeasures that limit the harm COVID–19 might otherwise cause. (85 section V of the Declaration to revise SW, Washington, DC 20201; 202–260– subsection (f) to clarify that observers FR 35100, June 8, 2020). On August 19, 0365, [email protected]. should be experienced in administering the former Secretary amended the intramuscular injections; delete SUPPLEMENTARY INFORMATION: The declaration to add additional categories subsection (g), change the prior Public Readiness and Emergency of Qualified Persons and amend the subsection (h) to subsection (g) and add Preparedness Act (PREP Act) authorizes category of disease, health condition, or a new subsection (h) to add additional the Secretary of Health and Human threat for which he recommended the categories of qualified persons covered Services (the Secretary) to issue a administration or use of the Covered under the PREP Act, and thus Declaration to provide liability Countermeasures. (85 FR 52136, August authorizes: (h) The following healthcare immunity to certain individuals and 24, 2020). On December 3, 2020, the entities (Covered Persons) against any professionals and students in a former Secretary amended the healthcare profession training program claim of loss caused by, arising out of, declaration to incorporate Advisory relating to, or resulting from the subject to the requirements of this Opinions of the General Counsel paragraph: manufacture, distribution, interpreting the PREP Act and the administration, or use of medical 1. Any midwife, paramedic, advanced Secretary’s Declaration and or intermediate emergency medical countermeasures (Covered authorizations issued by the Countermeasures), except for claims technician (EMT), physician assistant, Department’s Office of the Assistant respiratory therapist, dentist, podiatrist, involving ‘‘willful misconduct’’ as Secretary for Health as an Authority optometrist or veterinarian licensed or defined in the PREP Act. Under the Having Jurisdiction to respond; added certified to practice under the law of PREP Act, a Declaration may be an additional category of qualified any state who prescribes, dispenses, or amended as circumstances warrant. persons under Section V of the administers COVID–19 vaccines that are The PREP Act was enacted on Declaration; made explicit that the Covered Countermeasures under section December 30, 2005, as Public Law 109– Declaration covers all qualified VI of this Declaration in any jurisdiction 148, Division C, section 2. It amended pandemic and epidemic products as where the PREP Act applies in the Public Health Service (PHS) Act, defined under the PREP Act; added a association with a COVID–19 adding section 319F–3, which addresses third method of distribution to provide vaccination effort by a State, local, liability immunity, and section 319F–4, liability protections for, among other Tribal or territorial authority or by an which creates a compensation program. things, private distribution channels; institution in which the COVID–19 These sections are codified at 42 U.S.C. made explicit that there can be vaccine covered countermeasure is 247d–6d and 42 U.S.C. 247d–6e, situations where not administering a administered; respectively. Section 319F–3 of the PHS covered countermeasure to a particular 2. Any physician, advanced practice Act has been amended by the Pandemic individual can fall within the PREP Act registered nurse, registered nurse, and All-Hazards Preparedness and the Declaration’s liability practical nurse, pharmacist, pharmacy Reauthorization Act (PAHPRA), Public protections; made explicit that there are intern, midwife, paramedic, advanced Law 113–5, enacted on March 13, 2013 substantive Federal legal and policy or intermediate EMT, respiratory and the Coronavirus Aid, Relief, and issues and interests in having a unified therapist, dentist, physician assistant, Economic Security (CARES) Act, Public whole-of-nation response to the COVID– podiatrist, optometrist, or veterinarian Law 116–136, enacted on March 27, 19 pandemic among Federal, state, who has held an active license or 2020, to expand Covered local, and private-sector entities; revised certification under the law of any State Countermeasures under the PREP Act. the effective time period of the within the last five years, which is On January 31, 2020, the former Declaration; and republished the inactive, expired or lapsed, who Secretary, Alex M. Azar II, declared a declaration in full. (85 FR 79190, prescribes, dispenses, or administers public health emergency pursuant to December 9, 2020). On February 2, COVID–19 vaccines that are Covered section 319 of the PHS Act, 42 U.S.C. 2021, the Acting Secretary Norris Countermeasures under section VI of 247d, effective January 27, 2020, for the Cochran amended the Declaration to this Declaration in any jurisdiction entire United States to aid in the add additional categories of Qualified where the PREP Act applies in response of the nation’s health care Persons authorized to prescribe, association with a COVID–19 community to the COVID–19 outbreak. dispense, and administer COVID–19 vaccination effort by a State, local, Pursuant to section 319 of the PHS Act, vaccines that are covered Tribal or territorial authority or by an the Secretary renewed that declaration countermeasures under the Declaration institution in which the COVID–19 effective on April 26, 2020, July 25, (86 FR 7872, February 2, 2021). On vaccine covered countermeasure is

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administered, so long as the license or in basic cardiopulmonary individual who is authorized to certification was active and in good resuscitation; 1 prescribe, administer, or dispense such standing prior to the date it went vi. The healthcare professionals and countermeasures under the law of the inactive, expired or lapsed and was not students must comply with State in which the countermeasure was revoked by the licensing authority, recordkeeping and reporting prescribed, administered, or dispensed; surrendered while under suspension, requirements of the jurisdiction in or (B) ‘‘a person within a category of discipline or investigation by a licensing which he or she administers vaccines, persons so identified in a declaration by authority or surrendered following an including informing the patient’s the Secretary’’ under subsection (b) of arrest, and the individual is not on the primary-care provider when available, the PREP Act. 42 U.S.C. 247d–6d(i)(8). List of Excluded Individuals/Entities submitting the required immunization By this amendment to the Declaration, maintained by the Office of Inspector information to the State or local the Acting Secretary identifies an General; immunization information system additional categories of persons who are 3. Any medical, nursing, pharmacy, (vaccine registry), complying with qualified persons under section 247d– pharmacy intern, midwife, paramedic, requirements with respect to reporting 6d(i)(8)(B): licensed healthcare advanced or intermediate EMT, adverse events, and complying with professionals who may not ordinarily physician assistant, respiratory , requirements whereby the person prescribe, dispense or administer dental, podiatry, optometry or administering a vaccine must review the vaccines, additional healthcare veterinary student with appropriate vaccine registry or other vaccination providers with recently expired training in administering vaccines as records prior to administering a vaccine; licenses, and students in a healthcare determined by his or her school or and profession training program, subject to training program and supervision by a vii. The healthcare professionals and appropriate training, supervision, and currently practicing healthcare students comply with any applicable other specified requirements. The professional experienced in requirements (or conditions of use) as Acting Secretary anticipates that administering intramuscular injections set forth in the Centers for Disease significantly more vaccines will be who administers COVID–19 vaccines Control and Prevention (CDC) COVID– available to the public in the spring and that are Covered Countermeasures 19 vaccination provider agreement and summer of 2021, and wants to ensure under section VI of this Declaration in any other federal requirements that that states have the greatest flexibility in any jurisdiction where the PREP Act apply to the administration of COVID– mobilizing the workforce they will need applies in association with a COVID–19 19 vaccine(s). to engage in the largest vaccination vaccination effort by a State, local, effort in our Nation’s history. This Tribal or territorial authority or by an Description of This Amendment by amendment thus expands the pool of institution in which the COVID–19 Section vaccinators to individuals who have or vaccine covered countermeasure is Section V. Covered Persons can obtain training and the capability to administer vaccines even if prescribing, administered; Under the PREP Act and the dispensing and administering vaccines Subject to the following requirements: Declaration, a ‘‘qualified person’’ is a i. The vaccine must be authorized, is not within the scope of their license ‘‘covered person.’’ Subject to certain approved, or licensed by the FDA; or usual responsibilities, allowing limitations, a covered person is immune ii. Vaccination must be ordered and States, Territories, local areas and Tribes from suit and liability under Federal administered according to ACIP’s to use these individuals in their and State law with respect to all claims COVID–19 vaccine recommendation(s); vaccination programs. iii. The healthcare professionals and for loss caused by, arising out of, The Acting Secretary has determined students must have documentation of relating to, or resulting from the that there is an urgent need to expand completion of the Centers for Disease administration or use of a covered the pool of available COVID–19 Control and Prevention COVID–19 countermeasure if a declaration under vaccinators in order to respond Vaccine Training Modules and, if the PREP Act has been issued with effectively to the pandemic. As vaccine applicable, such additional training as respect to such countermeasure. supply is made more widely available may be required by the State, territory, ‘‘Qualified person’’ includes (A) a over the coming months, health care locality, or Tribal area in which they are licensed health professional or other system capacity and the vaccination prescribing, dispensing, or workforce are likely to become administering COVID–19 vaccines; 1 This requirement is satisfied by, among other increasingly strained throughout the things, a certification in basic cardiopulmonary iv. The healthcare professionals and resuscitation by an online program that has Nation. students must have documentation of an received accreditation from the American Nurses As qualified persons, these healthcare observation period by a currently Credentialing Center, the ACPE, or the professionals and students in healthcare practicing healthcare professional Accreditation Council for Continuing Medical profession training programs will be Education. The phrase ‘‘current certificate in basic experienced in administering cardiopulmonary resuscitation,’’ when used in the afforded liability protections in intramuscular injections, and for whom September 3, 2020 or October 20, 2020 OASH accordance with the PREP Act and the administering intramuscular injections authorizations, shall be interpreted the same way. terms of this amended Declaration. is in their ordinary scope of practice, See Guidance for Licensed Pharmacists and Second, to the extent that any State law Pharmacy Interns Regarding COVID–19 Vaccines who confirms competency of the and Immunity under the PREP Act, OASH, Sept. 3, that would otherwise prohibit the healthcare provider or student in 2020, available at https://www.hhs.gov/guidance/ healthcare professionals and students in preparation and administration of the sites/default/files/hhs-guidance-documents// healthcare profession training programs COVID–19 vaccine(s) to be administered licensed-pharmacists-and-pharmacy-interns- who are a ‘‘qualified person’’ from regarding-covid-19-vaccines-immunity.pdf (last and, if applicable, such additional visited Jan. 24, 2021); Guidance for PREP Act prescribing, dispensing, or training as may be required by the State, Coverage for Qualified Pharmacy Technicians and administering COVID–19 vaccines or territory, locality, or Tribal area in State-Authorized Pharmacy Interns for Childhood other Covered Countermeasures, such which they are prescribing, dispensing, Vaccines, COVID–19 Vaccines, and COVID–19 law is preempted. On May 19, 2020, the Testing, OASH, Oct. 20, 2020, available at https:// or administering COVID–19 vaccines; www.hhs.gov/guidance/sites/default/files/hhs- Office of the General Counsel issued an v. The healthcare professionals and guidance-documents//prep-act-guidance.pdf (last advisory opinion concluding that, students must have a current certificate visited Jan. 24, 2021). because licensed pharmacists are

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‘‘qualified persons’’ under this 3, 2020, and as amended on February 2, (b) Any person authorized to declaration, the PREP Act preempts 2021, is further amended pursuant to prescribe, administer, or dispense the state law that would otherwise prohibit section 319F–3(b)(4) of the PHS Act as Covered Countermeasures or who is such pharmacists from ordering and described below. All other sections of otherwise authorized to perform an administering authorized COVID–19 the Declaration remain in effect as activity under an Emergency Use diagnostic tests.2 The opinion relied in republished at 85 FR 79190 (December Authorization in accordance with part on the fact that the Congressional 9, 2020). Section 564 of the FD&C Act; delegation of authority to the Secretary 1. Covered Persons, section V, delete (c) Any person authorized to under the PREP Act to specify a class of in full and replace with: prescribe, administer, or dispense Covered Countermeasures in accordance persons, beyond those who are V. Covered Persons authorized to administer a covered with Section 564A of the FD&C Act; countermeasure under State law, as 42 U.S.C. 247d–6d(i)(2), (3), (4), (6), (d) A State-licensed pharmacist who ‘‘qualified persons’’ would be rendered (8)(A) and (B) orders and administers, and pharmacy a nullity in the absence of such Covered Persons who are afforded interns who administer (if the pharmacy liability immunity under this preemption. This opinion is intern acts under the supervision of Declaration are ‘‘manufacturers,’’ incorporated by reference into this such pharmacist and the pharmacy ‘‘distributors,’’ ‘‘program planners,’’ declaration. Based on the reasoning set intern is licensed or registered by his or ‘‘qualified persons,’’ and their officials, 5 forth in the May 19, 2020 advisory her State board of pharmacy), (1) agents, and employees, as those terms opinion, any State law that would vaccines that the Advisory Committee are defined in the PREP Act, and the otherwise prohibit a member of any of on Immunization Practices (ACIP) United States. ‘‘Order’’ as used herein the classes of ‘‘qualified persons’’ recommends to persons ages three and in guidance issued by the Office of specified in this declaration from through 18 according to ACIP’s standard the Assistant Secretary for Health 3 administering a covered countermeasure immunization schedule or (2) FDA means a provider medication order, is likewise preempted. In accordance authorized or FDA licensed COVID–19 which includes prescribing of vaccines, with section 319F–3(i)(8)(A) of the vaccines to persons ages three or older. or a laboratory order, which includes Public Health Service Act, a State Such State-licensed pharmacists and the prescribing laboratory orders, if remains free to expand the universe of State-licensed or registered interns required. In addition, I have determined individuals authorized to administer under their supervision are qualified that the following additional persons are covered countermeasures within its persons only if the following qualified persons: jurisdiction under State law. requirements are met: (a) Any person authorized in i. The vaccine must be authorized, The plain language of the PREP Act accordance with the public health and approved, or licensed by the FDA; makes clear that there is preemption of medical emergency response of the ii. In the case of a COVID–19 vaccine, state law as described above. Authority Having Jurisdiction, as the vaccination must be ordered and Furthermore, preemption of State law is described in Section VII below, to administered according to ACIP’s justified to respond to the nation-wide prescribe, administer, deliver, distribute COVID–19 vaccine recommendation(s); public health emergency caused by or dispense the Covered COVID–19 as it will enable States to Countermeasures, and their officials, www.hhs.gov/guidance/sites/default/files/hhs- quickly expand the vaccination agents, employees, contractors and guidance-documents//licensed-pharmacists-and- pharmacy-interns-regarding-covid-19-vaccines- workforce with additional qualified volunteers, following a Declaration of an healthcare professionals where State or immunity.pdf (last visited Jan. 24, 2021); Guidance Emergency, as that term is defined in for PREP Act Coverage for Qualified Pharmacy local requirements might otherwise Section VII of this Declaration; 4 Technicians and State-Authorized Pharmacy inhibit or delay allowing these Interns for Childhood Vaccines, COVID–19 Vaccines, and COVID–19 Testing, OASH, Oct. 20, healthcare professionals to participate 3 See Guidance for Licensed Pharmacists, COVID– 2020, available at https://www.hhs.gov/guidance/ in the COVID–19 vaccination program. 19 Testing, and Immunity Under the PREP Act, sites/default/files/hhs-guidance-documents//prep- OASH, Apr. 8, 2020, available at https:// Amendments to Declaration act-guidance.pdf (last visited Jan. 24, 2021); PREP www.hhs.gov/guidance/sites/default/files/hhs- Act Authorization for Pharmacies Distributing and guidance-documents//authorizing-licensed- Administering Certain Covered Countermeasures, Amended Declaration for Public pharmacists-to-order-and-administer-covid-19- Readiness and Emergency Preparedness Oct. 29, 2020, available at https://www.hhs.gov/ tests.pdf (last visited Jan. 24, 2021); Guidance for guidance/sites/default/files/hhs-guidance- Act Coverage for medical Licensed Pharmacists and Pharmacy Interns documents//prep-act-authorization-pharmacies- countermeasures against COVID–19. Regarding COVID–19 Vaccines and Immunity under administering-covered-countermeasures.pdf (last Section V of the March 10, 2020 the PREP Act, OASH, Sept. 3, 2020, available at visited Jan. 24, 2021) (collectively, OASH PREP Act https://www.hhs.gov/guidance/sites/default/files/ Authorizations). Nothing herein shall suggest that, Declaration under the PREP Act for hhs-guidance-documents//licensed-pharmacists- for purposes of the Declaration, the foregoing are medical countermeasures against and-pharmacy-interns-regarding-covid-19-vaccines- the only persons authorized in accordance with the COVID–19, as amended April 10, 2020, immunity.pdf (last visited Jan. 24, 2021). public health and medical emergency response of June 4, 2020, August 19, 2020, as 4 See, e.g., Guidance for Licensed Pharmacists, the Authority Having Jurisdiction. COVID–19 Testing, and Immunity Under the PREP 5 amended and republished on December Some states do not require pharmacy interns to Act, OASH, Apr. 8, 2020, available at https:// be licensed or registered by the state board of www.hhs.gov/guidance/sites/default/files/hhs- pharmacy. As used herein, ‘‘State-licensed or 2 Department of Health and Human Services guidance-documents//authorizing-licensed- registered intern’’ (or equivalent phrases) refers to General Counsel Advisory Opinion on the Public pharmacists-to-order-and-administer-covid-19- pharmacy interns authorized by the state or board Readiness and Emergency Preparedness Act, May tests.pdf (last visited Jan. 24, 2021); Guidance for of pharmacy in the state in which the practical 19, 2020, available at: https://www.hhs.gov/ PREP Act Coverage for COVID–19 Screening Tests pharmacy internship occurs. The authorization can, guidance/sites/default/files/hhs-guidance- at Nursing Homes, Assisted-Living Facilities, Long- but need not, take the form of a license from, or documents/prep-act-advisory-opinion-hhs-ogc.pdf/ Term-Care Facilities, and other Congregate registration with, the State board of pharmacy. See (last visited Jan. 24, 2021). See also, Department of Facilities, OASH, Aug. 31, 2020, available at Guidance for PREP Act Coverage for Qualified Justice Office of Legal Counsel Advisory Opinion https://www.hhs.gov/guidance/sites/default/files/ Pharmacy Technicians and State-Authorized for Robert P. Charrow, General Counsel of the hhs-guidance-documents/prep-act-coverage-for- Pharmacy Interns for Childhood Vaccines, COVID– Department of Health and Human Services, January screening-in-congregate-settings.pdf (last visited 19 Vaccines, and COVID–19 Testing, OASH, Oct. 12, 2021, available at: https://www.justice.gov/sites/ Jan. 24, 2021); Guidance for Licensed Pharmacists 20, 2020 at 2, available at https://www.hhs.gov/ default/files/opinions/attachments/2021/01/19/ and Pharmacy Interns Regarding COVID–19 guidance/sites/default/files/hhs-guidance- 2021-01-19-prep-act-preemption.pdf (last visited Vaccines and Immunity under the PREP Act, documents//prep-act-guidance.pdf (last visited Jan. Jan. 24, 2021). OASH, Sept. 3, 2020, available at https:// 24, 2021).

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iii. In the case of a childhood vaccine, provider when available, submitting the prescribes, dispenses, or administers the vaccination must be ordered and required immunization information to COVID–19 vaccines that are Covered administered according to ACIP’s the State or local immunization Countermeasures under section VI of standard immunization schedule; information system (vaccine registry), this Declaration in any jurisdiction iv. The licensed pharmacist must complying with requirements with where the PREP Act applies, other than have completed the immunization respect to reporting adverse events, and the State in which the license or training that the licensing State requires complying with requirements whereby certification is held, in association with for pharmacists to order and administer the person administering a vaccine must a COVID–19 vaccination effort by a vaccines. If the State does not specify review the vaccine registry or other federal, State, local Tribal or territorial training requirements for the licensed vaccination records prior to authority or by an institution in the pharmacist to order and administer administering a vaccine; State in which the COVID–19 vaccine vaccines, the licensed pharmacist must ix. The licensed pharmacist must covered countermeasure is complete a vaccination training program inform his or her childhood-vaccination administered, so long as the license or of at least 20 hours that is approved by patients and the adult caregiver certification of the healthcare the Accreditation Council for Pharmacy accompanying the child of the professional has not been suspended or Education (ACPE) to order and importance of a well-child visit with a restricted by any licensing authority, administer vaccines. Such a training pediatrician or other licensed primary surrendered while under suspension, program must include hands on care provider and refer patients as discipline or investigation by a licensing injection technique, clinical evaluation appropriate; and authority or surrendered following an of indications and contraindications of x. The licensed pharmacist and the arrest, and the individual is not on the vaccines, and the recognition and licensed or registered pharmacy intern List of Excluded Individuals/Entities treatment of emergency reactions to must comply with any applicable maintained by the Office of Inspector vaccines; requirements (or conditions of use) as General, subject to: (i) Documentation of v. The licensed or registered set forth in the Centers for Disease completion of the Centers for Disease pharmacy intern must complete a Control and Prevention (CDC) COVID– Control and Prevention COVID–19 practical training program that is 19 vaccination provider agreement and (CDC) Vaccine Training Modules 8 and, approved by the ACPE. This training any other federal requirements that for healthcare providers who are not program must include hands-on apply to the administration of COVID– currently practicing, documentation of injection technique, clinical evaluation 19 vaccine(s). an observation period by a currently of indications and contraindications of (e) Healthcare personnel using practicing healthcare professional vaccines, and the recognition and telehealth to order or administer experienced in administering treatment of emergency reactions to Covered Countermeasures for patients intramuscular injections, and for whom vaccines; in a state other than the state where the administering intramuscular injections vi. The licensed pharmacist and healthcare personnel are licensed or is in their ordinary scope of practice, licensed or registered pharmacy intern otherwise permitted to practice. When who confirms competency of the must have a current certificate in basic ordering and administering Covered healthcare provider in preparation and 6 cardiopulmonary resuscitation; Countermeasures by means of telehealth administration of the COVID–19 vii. The licensed pharmacist must to patients in a state where the vaccine(s) to be administered; complete a minimum of two hours of healthcare personnel are not already (g) Any member of a uniformed ACPE-approved, immunization-related permitted to practice, the healthcare service (including members of the continuing pharmacy education during personnel must comply with all National Guard in a Title 32 duty status) each State licensing period; requirements for ordering and (hereafter in this paragraph ‘‘service viii. The licensed pharmacist must administering Covered Countermeasures member’’) or Federal government, comply with recordkeeping and to patients by means of telehealth in the employee, contractor, or volunteer who reporting requirements of the state where the healthcare personnel are prescribes, administers, delivers, jurisdiction in which he or she permitted to practice. Any state law that distributes or dispenses a Covered administers vaccines, including prohibits or effectively prohibits such a Countermeasure. Such Federal informing the patient’s primary-care qualified person from ordering and government service members, administering Covered Countermeasures 6 employees, contractors, or volunteers This requirement is satisfied by, among other 7 things, a certification in basic cardiopulmonary by means of telehealth is preempted. are qualified persons if the following resuscitation by an online program that has Nothing in this Declaration shall requirement is met: the executive received accreditation from the American Nurses preempt state laws that permit department or agency by or for which Credentialing Center, the ACPE, or the additional persons to deliver telehealth the Federal service member, employee, Accreditation Council for Continuing Medical Education. The phrase ‘‘current certificate in basic services; contractor, or volunteer is employed, cardiopulmonary resuscitation,’’ when used in the (f) Any healthcare professional or contracts, or volunteers has authorized September 3, 2020 or October 20, 2020 OASH other individual who holds an active or could authorize that service member, authorizations, shall be interpreted the same way. license or certification permitting the See Guidance for Licensed Pharmacists and employee, contractor, or volunteer to Pharmacy Interns Regarding COVID–19 Vaccines person to prescribe, dispense, or prescribe, administer, deliver, and Immunity under the PREP Act, OASH, Sept. 3, administer vaccines under the law of distribute, or dispense the Covered 2020, available at https://www.hhs.gov/guidance/ any State as of the effective date of this Countermeasure as any part of the sites/default/files/hhs-guidance-documents// amendment, or as authorized under the licensed-pharmacists-and-pharmacy-interns- duties or responsibilities of that service regarding-covid-19-vaccines-immunity.pdf (last section V(d) of this Declaration, who member, employee, contractor, or visited Jan. 24, 2021); Guidance for PREP Act volunteer, even if those authorized Coverage for Qualified Pharmacy Technicians and 7 See, e.g., Advisory Opinion 20–02 on the Public duties or responsibilities ordinarily State-Authorized Pharmacy Interns for Childhood Readiness and Emergency Preparedness Act and the Vaccines, COVID–19 Vaccines, and COVID–19 Secretary’s Declaration under the Act, May 19, would not extend to members of the Testing, OASH, Oct. 20, 2020, available at https:// 2020, available at https://www.hhs.gov/guidance/ www.hhs.gov/guidance/sites/default/files/hhs- sites/default/files/hhs-guidance-documents/ 8 See COVID–19 Vaccine Training Modules, guidance-documents//prep-act-guidance.pdf (last advisory-opinion-20-02-hhs-ogc-prep-act.pdf (last available at https://www.cdc.gov/vaccines/covid-19/ visited Jan. 24, 2021). visited Jan. 24, 2021). training.html.

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public or otherwise would be more currently practicing healthcare vi. The healthcare professionals and limited in scope than the activities such professional experienced in students must comply with service member, employees, contractors, administering intramuscular injections recordkeeping and reporting or volunteers are authorized to carry out who administers COVID–19 vaccines requirements of the jurisdiction in under this declaration; and that are Covered Countermeasures which he or she administers vaccines, (h) The following healthcare under section VI of this Declaration in including informing the patient’s professionals and students in a any jurisdiction where the PREP Act primary-care provider when available, healthcare profession training program applies in association with a COVID–19 submitting the required immunization subject to the requirements of this vaccination effort by a State, local, information to the State or local paragraph: Tribal or territorial authority or by an immunization information system 1. Any midwife, paramedic, advanced institution in which the COVID–19 (vaccine registry), complying with or intermediate emergency medical vaccine covered countermeasure is requirements with respect to reporting technician (EMT), physician assistant, administered; adverse events, and complying with respiratory therapist, dentist, podiatrist, Subject to the following requirements: requirements whereby the person optometrist or veterinarian licensed or i. The vaccine must be authorized, administering a vaccine must review the certified to practice under the law of approved, or licensed by the FDA; vaccine registry or other vaccination any state who prescribes, dispenses, or ii. Vaccination must be ordered and records prior to administering a vaccine; administers COVID–19 vaccines that are administered according to ACIP’s and Covered Countermeasures under section COVID–19 vaccine recommendation(s); vii. The healthcare professionals and VI of this Declaration in any jurisdiction iii. The healthcare professionals and students comply with any applicable where the PREP Act applies in students must have documentation of requirements (or conditions of use) as association with a COVID–19 completion of the Centers for Disease set forth in the Centers for Disease vaccination effort by a State, local, Control and Prevention COVID–19 Control and Prevention (CDC) COVID– Tribal or territorial authority or by an Vaccine Training Modules and, if 19 vaccination provider agreement and institution in which the COVID–19 applicable, such additional training as any other federal requirements that vaccine covered countermeasure is may be required by the State, territory, apply to the administration of COVID– administered; locality, or Tribal area in which they are 19 vaccine(s). 2. Any physician, advanced practice prescribing, dispensing, or Nothing in this Declaration shall be registered nurse, registered nurse, administering COVID–19 vaccines; construed to affect the National Vaccine practical nurse, pharmacist, pharmacy iv. The healthcare professionals and Injury Compensation Program, intern, midwife, paramedic, advanced students must have documentation of an including an injured party’s ability to or intermediate EMT, respiratory observation period by a currently obtain compensation under that therapist, dentist, physician assistant, practicing healthcare professional program. Covered countermeasures that podiatrist, optometrist, or veterinarian experienced in administering are subject to the National Vaccine who has held an active license or intramuscular injections, and for whom Injury Compensation Program certification under the law of any State administering vaccinations is in their authorized under 42 U.S.C. 300aa–10 et within the last five years, which is ordinary scope of practice, who seq. are covered under this Declaration inactive, expired or lapsed, who confirms competency of the healthcare for the purposes of liability immunity prescribes, dispenses, or administers provider or student in preparation and and injury compensation only to the COVID–19 vaccines that are Covered administration of the COVID–19 extent that injury compensation is not Countermeasures under section VI of vaccine(s) to be administered and, if provided under that Program. All other this Declaration in any jurisdiction applicable, such additional training as terms and conditions of the Declaration where the PREP Act applies in may be required by the State, territory, apply to such covered countermeasures. association with a COVID–19 locality, or Tribal area in which they are 2. Effective Time Period, section XII, vaccination effort by a State, local, prescribing, dispensing, or delete in full and replace with: Tribal or territorial authority or by an administering COVID–19 vaccines; Liability protections for any institution in which the COVID–19 v. The healthcare professionals and respiratory protective device approved vaccine covered countermeasure is students must have a current certificate by NIOSH under 42 CFR part 84, or any administered, so long as the license or in basic cardiopulmonary successor regulations, through the certification was active and in good 9 resuscitation; means of distribution identified in standing prior to the date it went Section VII(a) of this Declaration, begin inactive, expired or lapsed and was not 9 This requirement is satisfied by, among other on March 27, 2020 and extend through revoked by the licensing authority, things, a certification in basic cardiopulmonary October l, 2024. surrendered while under suspension, resuscitation by an online program that has received accreditation from the American Nurses Liability protections for all other discipline or investigation by a licensing Credentialing Center, the ACPE, or the Covered Countermeasures identified in authority or surrendered following an Accreditation Council for Continuing Medical Section VI of this Declaration, through Education. The phrase ‘‘current certificate in basic arrest, and the individual is not on the means of distribution identified in List of Excluded Individuals/Entities cardiopulmonary resuscitation,’’ when used in the September 3, 2020 or October 20, 2020 OASH Section VII(a) of this Declaration, begin maintained by the Office of Inspector authorizations, shall be interpreted the same way. on February 4, 2020 and extend through General; See Guidance for Licensed Pharmacists and October l, 2024. 3. Any medical, nursing, pharmacy, Pharmacy Interns Regarding COVID–19 Vaccines and Immunity under the PREP Act, OASH, Sept. 3, Liability protections for all Covered pharmacy intern, midwife, paramedic, Countermeasures administered and advanced or intermediate EMT, 2020, available at https://www.hhs.gov/guidance/ sites/default/files/hhs-guidance-documents// used in accordance with the public physician assistant, respiratory therapy, licensed-pharmacists-and-pharmacy-interns- health and medical response of the dental, podiatry, optometry or regarding-covid-19-vaccines-immunity.pdf (last Authority Having Jurisdiction, as veterinary student with appropriate visited Jan. 24, 2021); Guidance for PREP Act Coverage for Qualified Pharmacy Technicians and training in administering vaccines as State-Authorized Pharmacy Interns for Childhood www.hhs.gov/guidance/sites/default/files/hhs- determined by his or her school or Vaccines, COVID–19 Vaccines, and COVID–19 guidance-documents//prep-act-guidance.pdf (last training program and supervision by a Testing, OASH, Oct. 20, 2020, available at https:// visited Jan. 24, 2021).

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identified in Section VII(b) of this evaluation of individual intramural burden (i.e., the time, effort, and Declaration, begin with a Declaration of programs and projects conducted by the resources used by the respondents to Emergency as that term is defined in NATIONAL INSTITUTE OF DENTAL & respond), the estimated cost to the Section VII (except that, with respect to CRANIOFACIAL RESEARCH, including respondent, and the actual information qualified persons who order or consideration of personnel collection instruments. administer a routine childhood qualifications and performance, and the DATES: Comments are encouraged and vaccination that ACIP recommends to competence of individual investigators, will be accepted for 60 days until May persons ages three through 18 according the disclosure of which would 17, 2021. to ACIP’s standard immunization constitute a clearly unwarranted ADDRESSES: schedule, liability protections began on invasion of personal privacy. All submissions received must include the OMB Control Number August 24, 2020), and last through (a) Name of Committee: Board of Scientific the final day the Declaration of 1615–0046 in the body of the letter, the Counselors, National Institute of Dental and agency name and Docket ID USCIS– Emergency is in effect, or (b) October l, Craniofacial Research. 2024, whichever occurs first. Date: May 18–19, 2021. 2006–0062. Submit comments via the Liability protections for all Covered Time: 9:00 a.m. to 4:15 p.m. Federal eRulemaking Portal website at Countermeasures identified in Section Agenda: To review and evaluate personnel https://www.regulations.gov under e- VII(c) of this Declaration begin on qualifications and performance, and Docket ID number USCIS–2006–0062. December 9, 2020 and last through (a) competence of individual investigators. USCIS is limiting communications for the final day the Declaration of Place: National Institutes of Health, 6701 this Notice as a result of USCIS’ COVID– Democracy Blvd., Bethesda, MD 20892 19 response actions. Emergency is in effect, or (b) October l, (Virtual Meeting). 2024, whichever occurs first. Contact Person: Alicia J. Dombroski, Ph.D., FOR FURTHER INFORMATION CONTACT: Liability protections for Qualified Director, Division of Extramural Activities, USCIS, Office of Policy and Strategy, Persons under section V(f) of the Natl Inst of Dental and Craniofacial Research, Regulatory Coordination Division, declaration begin on February 2, 2021, National Institutes of Health, Bethesda, MD Samantha Deshommes, Chief, telephone and last through October 1, 2024. 20892. number (240) 721–3000 (This is not a Liability protections for Qualified (Catalogue of Federal Domestic Assistance toll-free number. Comments are not Persons under section V(g) of the Program No. 93.121, Oral Diseases and accepted via telephone message). Please declaration begin on February 16, 2021, Disorders Research, National Institutes of Health, HHS) note contact information provided here and last through October 1, 2024. is solely for questions regarding this Liability protections for Qualified Dated: March 10, 2021. notice. It is not for individual case Persons who are physicians, advanced Melanie J. Pantoja, status inquiries. Applicants seeking practice registered nurses, registered Program Analyst, Office of Federal Advisory information about the status of their nurses, or practical nurses under section Committee Policy. individual cases can check Case Status V(h) of the declaration begins on [FR Doc. 2021–05351 Filed 3–15–21; 8:45 am] Online, available at the USCIS website February 2, 2021 and last through BILLING CODE 4140–01–P at https://www.uscis.gov, or call the October 1, 2024, with additional USCIS Contact Center at 800–375–5283 conditions effective as of March 11, (TTY 800–767–1833). 2021 and liability protections for all DEPARTMENT OF HOMELAND SUPPLEMENTARY INFORMATION: other Qualified persons under section SECURITY V(h) begins on March 11, 2021 and last Comments through October 1, 2024. U.S. Citizenship and Immigration You may access the information Services Authority: 42 U.S.C. 247d–6d. collection instrument with instructions Norris Cochran, [OMB Control Number 1615–0046] or additional information by visiting the Acting Secretary, Department of Health and Federal eRulemaking Portal site at: Human Services. Agency Information Collection https://www.regulations.gov and Activities; Extension, Without Change, [FR Doc. 2021–05401 Filed 3–11–21; 4:15 pm] entering USCIS–2006–0062 in the of a Currently Approved Collection: BILLING CODE 4150–37–P search box. All submissions will be Interagency Alien Witness and posted, without change, to the Federal Informant Record eRulemaking Portal at https:// DEPARTMENT OF HEALTH AND AGENCY: U.S. Citizenship and www.regulations.gov, and will include HUMAN SERVICES Immigration Services, Department of any personal information you provide. Homeland Security. Therefore, submitting this information National Institutes of Health makes it public. You may wish to ACTION: 60-day notice. consider limiting the amount of National Institute of Dental & SUMMARY: The Department of Homeland personal information that you provide Craniofacial Research; Notice of Security (DHS), U.S. Citizenship and in any voluntary submission you make Closed Meeting Immigration Services (USCIS) invites to DHS. DHS may withhold information Pursuant to section 10(d) of the the general public and other Federal provided in comments from public Federal Advisory Committee Act, as agencies to comment upon this viewing that it determines may impact amended, notice is hereby given of a proposed extension of a currently the privacy of an individual or is meeting of the Board of Scientific approved collection of information. In offensive. For additional information, Counselors, National Institute of Dental accordance with the Paperwork please read the Privacy Act notice that and Craniofacial Research. Reduction Act (PRA) of 1995, the is available via the link in the footer of The meeting will be closed to the information collection notice is https://www.regulations.gov. public as indicated below in accordance published in the Federal Register to Written comments and suggestions with the provisions set forth in section obtain comments regarding the nature of from the public and affected agencies 552b(c)(6), Title 5 U.S.C., as amended the information collection, the should address one or more of the for the review, discussion, and categories of respondents, the estimated following four points:

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(1) Evaluate whether the proposed estimated hour burden per response is Regulatory Coordination Division, collection of information is necessary 1 hours. Samantha Deshommes, Chief, for the proper performance of the (6) An estimate of the total public Telephone number (240) 271–3000 functions of the agency, including burden (in hours) associated with the (This is not a toll-free number; whether the information will have collection: The total estimated annual comments are not accepted via practical utility; hour burden associated with this telephone message.). Please note contact (2) Evaluate the accuracy of the collection is 60 hours. information provided here is solely for agency’s estimate of the burden of the (7) An estimate of the total public questions regarding this notice. It is not proposed collection of information, burden (in cost) associated with the for individual case status inquiries. including the validity of the collection: The estimated total annual Applicants seeking information about methodology and assumptions used; cost burden associated with this the status of their individual cases can (3) Enhance the quality, utility, and collection of information is $0. check Case Status Online, available at clarity of the information to be Dated: March 9, 2021. the USCIS website at http:// www.uscis.gov, or call the USCIS collected; and Samantha L. Deshommes, (4) Minimize the burden of the Contact Center at (800) 375–5283; TTY Chief, Regulatory Coordination Division, (800) 767–1833. collection of information on those who Office of Policy and Strategy, U.S. Citizenship are to respond, including through the and Immigration Services, Department of SUPPLEMENTARY INFORMATION: use of appropriate automated, Homeland Security. Comments electronic, mechanical, or other [FR Doc. 2021–05393 Filed 3–15–21; 8:45 am] The information collection notice was technological collection techniques or BILLING CODE 9111–97–P other forms of information technology, previously published in the Federal e.g., permitting electronic submission of Register on September 29, 2020, at 85 responses. DEPARTMENT OF HOMELAND FR 61020, allowing for a 60-day public SECURITY comment period. USCIS did not receive Overview of This Information any comments in connection with the Collection U.S. Citizenship and Immigration 60-day notice. (1) Type of Information Collection: Services You may access the information collection instrument with instructions, Extension, Without Change, of a [OMB Control Number 1615–0044] Currently Approved Collection. or additional information by visiting the Federal eRulemaking Portal site at: (2) Title of the Form/Collection: Agency Information Collection http://www.regulations.gov and enter Interagency Alien Witness and Activities; Extension, Without Change, USCIS–2007–0012 in the search box. Informant Record. of a Currently Approved Collection: The comments submitted to USCIS via (3) Agency form number, if any, and Application for Action on an Approved this method are visible to the Office of the applicable component of the DHS Application or Petition Management and Budget and comply sponsoring the collection: I–854A and I– AGENCY: U.S. Citizenship and with the requirements of 5 CFR 854B; USCIS. 1320.12(c). All submissions will be (4) Affected public who will be asked Immigration Services, Department of Homeland Security. posted, without change, to the Federal or required to respond, as well as a brief eRulemaking Portal at http:// ACTION: 30-Day notice. abstract: Primary: Federal Government. www.regulations.gov, and will include The Form I–854 will enable the U.S. SUMMARY: The Department of Homeland any personal information you provide. Immigration and Customs Enforcement Security (DHS), U.S. Citizenship and Therefore, submitting this information (ICE) to fulfill those responsibilities. A Immigration Services (USCIS) will be makes it public. You may wish to law enforcement agency may request S submitting the following information consider limiting the amount of nonimmigrant classification for an collection request to the Office of personal information that you provide essential witness or informant by Management and Budget (OMB) for in any voluntary submission you make completing this form, which requires review and clearance in accordance to DHS. DHS may withhold information certifications by both the law with the Paperwork Reduction Act of provided in comments from public enforcement agency (e.g., that it will 1995. The purpose of this notice is to viewing that it determines may impact collect the alien’s statutorily-required allow an additional 30 days for public the privacy of an individual or is quarterly reports and oversee the alien’s comments. offensive. For additional information, departure, if that becomes necessary) please read the Privacy Act notice that and the alien. The law enforcement DATES: Comments are encouraged and will be accepted until April 15, 2021. is available via the link in the footer of agency files a properly completed Form http://www.regulations.gov. I–854 with the Criminal Division, ADDRESSES: Written comments and/or Written comments and suggestions Department of Justice, which may suggestions regarding the item(s) from the public and affected agencies certify the law enforcement agency contained in this notice, especially should address one or more of the request to the U.S. Citizenship and regarding the estimated public burden following four points: Immigration Services (USCIS). and associated response time, must be (1) Evaluate whether the proposed (5) An estimate of the total number of submitted via the Federal eRulemaking collection of information is necessary respondents and the amount of time Portal website at http:// for the proper performance of the estimated for an average respondent to www.regulations.gov under e-Docket ID functions of the agency, including respond: The estimated total number of number USCIS–2007–0012. All whether the information will have respondents for the information submissions received must include the practical utility; collection I–854A is 10 and the OMB Control Number 1615–0044 in the (2) Evaluate the accuracy of the estimated hour burden per response is body of the letter, the agency name and agency’s estimate of the burden of the 3 hours. The estimated total number of Docket ID USCIS–2007–0012. proposed collection of information, respondents for the information FOR FURTHER INFORMATION CONTACT: including the validity of the collection I–854B is 30 and the USCIS, Office of Policy and Strategy, methodology and assumptions used

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(3) Enhance the quality, utility, and DEPARTMENT OF HOUSING AND notice announces the availability of the clarity of the information to be URBAN DEVELOPMENT FY 2021 inflation factors and describes the methodology for calculating them. collected; and [Docket No. FR–6248–N–01] (4) Minimize the burden of the Tables in PDF and Microsoft Excel formats showing Renewal Funding collection of information on those who Section 8 Housing Assistance Inflation Factors (RFIFs) by HUD Fair are to respond, including through the Payments Program—Fiscal Year (FY) 2021 Inflation Factors for Public Market Rent Area are available use of appropriate automated, electronically from the HUD data electronic, mechanical, or other Housing Agency (PHA) Renewal Funding information page at: https:// technological collection techniques or www.huduser.gov/portal/datasets/rfif/ other forms of information technology, AGENCY: Office of the Assistant rfif.html. e.g., permitting electronic submission of Secretary for Policy Development and II. Methodology responses. Research, HUD. ACTION: Notice. RFIFs are used to adjust the allocation Overview of This Information of Housing Choice Voucher (HCV) Collection SUMMARY: This notice establishes program funds to PHAs for local (1) Type of Information Collection Renewal Funding Inflation Factors changes in rents, utility costs, and Request: Extension, Without Change, of (RFIFs) to adjust Fiscal Year (FY) 2021 tenant incomes. To calculate the RFIFs, HUD first forecasts a national inflation a Currently Approved Collection. renewal funding for the Housing Choice Voucher (HCV) Program of each public factor, which is the annual change in (2) Title of the Form/Collection: housing agency (PHA), as required by the national average Per Unit Cost Application for Action on an Approved the Consolidated Appropriations Act, (PUC). HUD then calculates individual Application or Petition. 2021. The notice apportions the area inflation factors, which are based (3) Agency form number, if any, and expected percent change in national Per on the annual changes in the two- the applicable component of the DHS Unit Cost (PUC) for the HCV program, bedroom Fair Market Rent (FMR) for sponsoring the collection: I–824; USCIS. 5.80 percent, to each PHA based on the each area. Finally, HUD adjusts the change in Fair Market Rents (FMRs) for individual area inflation factors to be (4) Affected public who will be asked their operating area to produce the FY consistent with the national inflation or required to respond, as well as a brief 2021 RFIFs. HUD’s FY 2021 factor. abstract: Primary: Individuals or methodology is the same as that which HUD’s forecast of the national average households. This information collection was used in FY 2020. PUC is based on forecasts of gross rent is used to request a duplicate approval and tenant income. Each forecast is DATES: Effective Date: March 16, 2021. notice, as well as to notify and to verify produced using historical and the U.S. Consulate that a petition has FOR FURTHER INFORMATION CONTACT: forecasted macroeconomic data as been approved or that a person has been Miguel A. Fontanez, Director, Housing independent variables, where the Voucher Financial Division, Office of adjusted to permanent resident status. forecasts are consistent with the Public Housing and Voucher Programs, Economic Assumptions of the (5) An estimate of the total number of Office of Public and Indian Housing, Administration’s FY 2022 Budget. The respondents and the amount of time telephone number 202–402–4212; or forecast of gross rent is itself based on estimated for an average respondent to Adam Bibler, Program Parameters and forecasts of the Consumer Price Index respond: The estimated total number of Research Division, Office of Policy (CPI) Rent of Primary Residence Index respondents for the information Development and Research, telephone and the CPI Fuels and Utilities Index. collection I–824 is 10,571 and the number 202–402–6057, for technical Forecasted values of these series are estimated hour burden per response is information regarding the development applied to the FY 2021 national average 0.42 hour. of the schedules for specific areas or the two-bedroom FMR to produce a CY (6) An estimate of the total public methods used for calculating the 2021 value. A ‘‘notional’’ PUC is burden (in hours) associated with the inflation factors. Their mailing address calculated as the difference between is: Department of Housing and Urban collection: The total estimated annual gross rent value and 30 percent of tenant Development, 451 7th Street SW, hour burden associated with this income (the standard for tenant rent Washington, DC 20410. Hearing- or collection is 4,440 hours. contribution in the voucher program). speech-impaired persons may contact The change between the forecasted CY (7) An estimate of the total public the Federal Relay Service at 800–877– 2021 notional PUC and the CY 2020 burden (in cost) associated with the 8339 (TTY). (Other than the ‘‘800’’ TTY notional PUC is the expected national collection: The estimated total annual number, the above-listed telephone change in PUC, or 5.80 percent. HUD cost burden associated with this numbers are not toll free.) uses a notional PUC as opposed to the collection of information is $1,361,016. SUPPLEMENTARY INFORMATION: actual PUC to project costs that are consistent with PHAs leasing the same Dated: March 9, 2021. I. Background Samantha L Deshommes, number and quality of units. For more Division L, Title II of the Consolidated information on HUD’s forecast Chief, Regulatory Coordination Division, Appropriations Act, 2021 requires that methodology, see 82 FR 26710. Office of Policy and Strategy, U.S. Citizenship the HUD Secretary, for the calendar year The inflation factor for an individual and Immigration Services, Department of 2021 funding cycle, provide renewal geographic area is based on the Homeland Security. funding for each public housing agency annualized change in the area’s FMR [FR Doc. 2021–05392 Filed 3–15–21; 8:45 am] (PHA) based on validated voucher between FY 2020 and FY 2021. These BILLING CODE 9111–97–P management system (VMS) leasing and changes in FMRs are then scaled such cost data for the prior calendar year and that the voucher-weighted average of all by applying an inflation factor as individual area inflation factors is equal established by the Secretary, by notice to the national inflation factor, i.e., the published in the Federal Register. This expected annual change in national PUC

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from CY 2020 to CY 2021, and such that National Environmental Policy Act of may also file a written request for a no area has a factor less than one. For 1969 (42 U.S.C. 4321). hearing on the application on or before PHAs operating in multiple FMR areas, April 15, 2021. Todd Richardson, HUD calculates a voucher-weighted General Deputy Assistant Secretary for Policy, ADDRESSES: Written comments should average inflation factor based on the Development and Research. be sent to: Drug Enforcement count of vouchers in each FMR area [FR Doc. 2021–05365 Filed 3–15–21; 8:45 am] Administration, Attention: DEA Federal administered by the PHA as captured in BILLING CODE 4210–67–P Register Representative/DPW, 8701 HUD administrative data as of December Morrissette Drive, Springfield, Virginia 31, 2020. 22152. All requests for a hearing must III. The Use of Inflation Factors DEPARTMENT OF JUSTICE be sent to: Drug Enforcement Administration, Attn: Administrator, HUD subsequently applies the Drug Enforcement Administration 8701 Morrissette Drive, Springfield, calculated individual area inflation Virginia 22152. All requests for a [Docket No. DEA–709] factors to eligible renewal funding for hearing should also be sent to: (1) Drug each PHA based on VMS leasing and Bulk Manufacturer of Controlled Enforcement Administration, Attn: cost data for the prior calendar year. Substances Application: Cambridge Hearing Clerk/OALJ, 8701 Morrissette Isotope Lab; Correction Drive, Springfield, Virginia 22152; and IV. Geographic Areas and Area (2) Drug Enforcement Administration, Definitions AGENCY: Drug Enforcement Attn: DEA Federal Register Administration, Justice. Representative/DPW, 8701 Morrissette As explained above, inflation factors Drive, Springfield, Virginia 22152. based on area FMR changes are ACTION: Notice of application; produced for all FMR areas and applied correction. SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 1301.34(a), this to eligible renewal funding for each SUMMARY: The Drug Enforcement PHA. The tables showing the RFIFs, Administration (DEA) published a is notice that on February 17, 2021, available electronically from the HUD document in the Federal Register of Purisys, LLC, 1550 Olympic Drive, data information page, list the inflation September 14, 2020, concerning a notice Athens, Georgia 30601, applied to be factors for each FMR area on a state-by- of application. The document contained registered as an importer of the state basis. The inflation factors use the a misspelling (Isotype vs. Isotope). following basic class(es) of controlled same OMB metropolitan area substance(s): SUPPLEMENTARY INFORMATION: definitions, as revised by HUD, that are used in the FY 2021 FMRs. PHAs Correction Marihuana Extract ...... 7350 I Marihuana ...... 7360 I should refer to the Area Definitions In the Federal Register of September Tetrahydrocannabinols ..... 7370 I Table on the following web page to 14, 2020, in FR Doc. 2020–20160 (85 FR Noroxymorphone ...... 7379 II make certain that they are referencing 56633), on page 56633–56634, correct Phenylacetone ...... 8501 II the correct inflation factors: http:// Levorphanol ...... 9220 II all instances of the registrant name to Thebaine ...... 9333 II www.huduser.org/portal/datasets/rfif/ read Cambridge Isotope Lab. _ _ _ _ Poppy Straw Concentrate 9670 II FY2021/FY2021 RFIF FMR AREA Tapentadol ...... 9780 II REPORT.pdf. The Area Definitions William T. McDermott, Assistant Administrator. Table lists areas in alphabetical order by The company plans to import drug [FR Doc. 2021–05358 Filed 3–15–21; 8:45 am] state, and the counties associated with code 8501, Phenylacetone and drug each area. In the six New England states, BILLING CODE 4410–09–P code 9670, Poppy Straw Concentrate to the listings are for counties or parts of bulk manufacture other controlled counties as defined by towns or cities. DEPARTMENT OF JUSTICE substances for distribution to its HUD is also releasing the data in customers. The company plans to Microsoft Excel format to assist users Drug Enforcement Administration import impurities of buprenorphine that who may wish to use these data in other have been determined by DEA to be calculations. The Excel file is available [Docket No. DEA–805] captured under drug code 9333, at https://www.huduser.gov/portal/ Thebaine. In reference to drug codes datasets/rfif/rfif.html. Note that, as Importer of Controlled Substances Application: Purisys, LLC 73760, Marihuana and 7370, described earlier, the actual renewal Tetrahydrocannabinols the company funding inflation factor applied to AGENCY: Drug Enforcement plans to import a Synthetic Cannabidiol agency funding will be the voucher- Administration, Justice. and a Synthetic Tetrahydrocannabinol. weighted average of the FMR area ACTION: Notice of application. No other activity for these drug codes is factors when the PHA operates in authorized for this registration. multiple areas. SUMMARY: Purisys, LLC has applied to be Placement of these drug codes on the registered as an importer of basic company’s registration does not VI. Environmental Impact class(es) of controlled substance(s). translate into automatic approval of This notice involves a statutorily Refer to Supplementary Information subsequent permit applications to required establishment of a rate or cost listed below for further drug import controlled substances. determination which does not constitute information. Approval of permit applications will a development decision affecting the DATES: Registered bulk manufacturers of occur only when the registrant’s physical condition of specific project the affected basic class(es), and business activity is consistent with what areas or building sites. Accordingly, applicants therefore, may file written is authorized under 21 U.S.C. 952(a)(2). under 24 CFR 50.19(c)(6), this notice is comments on or objections to the Authorization will not extend to the categorically excluded from issuance of the proposed registration on import of Food and Drug environmental review under the or before April 15, 2021. Such persons Administration-approved or non-

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approved finished dosage forms for the novel coronavirus (COVID–19). adams.html. To begin the search, select commercial sale. Schedule updates, including weather- ‘‘Begin Web-based ADAMS Search.’’ For related cancellations, are also available problems with ADAMS, please contact William T. McDermott, at www.ntsb.gov. the NRC’s Public Document Room (PDR) Assistant Administrator. The National Transportation Safety reference staff at 1–800–397–4209, 301– [FR Doc. 2021–05356 Filed 3–15–21; 8:45 am] Board is holding this meeting under the 415–4737, or by email to pdr.resource@ BILLING CODE 4410–09–P Government in the Sunshine Act, 5 nrc.gov. The ADAMS accession number U.S.C. 552(b). for each document referenced (if it is Dated: March 12, 2021. available in ADAMS) is provided the NATIONAL CREDIT UNION Candi R. Bing, first time that it is mentioned in this ADMINISTRATION document. Federal Register Liaison Officer. • Attention: The PDR, where you may Sunshine Act Meetings [FR Doc. 2021–05551 Filed 3–12–21; 4:50 pm] examine and order copies of public BILLING CODE 7533–01–P documents, is currently closed. You TIME AND DATE: 10:00 a.m., Thursday, may submit your request to the PDR via March 18, 2021. email at [email protected] or call PLACE: Due to the COVID–19 Pandemic, NUCLEAR REGULATORY 1–800–397–4209 or 301–415–4737, the meeting will be open to the public COMMISSION between 8:00 a.m. and 4:00 p.m. (EST), via live webcast only. Visit the agency’s Monday through Friday, except Federal homepage (www.ncua.gov) and access [Docket Nos. 50–289 and 50–320; NRC– 2021–0069] holidays. the provided webcast link. FOR FURTHER INFORMATION CONTACT: STATUS: This meeting will be open to the Exelon Generation Company, LLC; Theodore Smith, Office of Nuclear public. TMI-2 Solutions, LLC; Three Mile Island Material Safety and Safeguards, U.S. MATTERS TO BE CONSIDERED: Nuclear Station, Units 1 and 2 Nuclear Regulatory Commission, 1. NCUA Rules and Regulations, Washington, DC 20555–0001; telephone: AGENCY: Nuclear Regulatory Central Liquidity Facility. 301–415–6721, email: Theodore.Smith@ Commission. 2. NCUA Rules and Regulations, Asset nrc.gov. ACTION: Exemptions; issuance. Thresholds Pertaining to Large Credit SUPPLEMENTARY INFORMATION: The text of Unions. the exemptions is attached. 3. Board Briefing, NCUA Guaranteed SUMMARY: The U.S. Nuclear Regulatory Note and Asset Management Estates Commission (NRC) has issued Dated: March 11, 2021. Programs. exemptions in response to a request to For the Nuclear Regulatory Commission. reduce the required level of primary CONTACT PERSON FOR MORE INFORMATION: Bruce A. Watson, offsite liability insurance from $450 Melane Conyers-Ausbrooks, Secretary of Chief, Reactor Decommissioning Branch, million to $100 million and to eliminate the Board, Telephone: 703–518–6304. Division of Decommissioning, Uranium the requirement to carry secondary Recovery and Waste Programs, Office of Melane Conyers-Ausbrooks, financial protection for Three Mile Nuclear Material Safety and Safeguards. Island Nuclear Station, Unit 1 and to Secretary of the Board. Attachment—Exemption [FR Doc. 2021–05468 Filed 3–12–21; 11:15 am] reduce the required level of primary NUCLEAR REGULATORY BILLING CODE 7535–01–P offsite liability insurance in the event of an extraordinary nuclear occurrence COMMISSIOIN from $200 million to $100 million for Docket Nos. 50–289 and 50–320 Three Mile Island Nuclear Station, Unit NATIONAL TRANSPORTATION Exelon Generation Company, LLC SAFETY BOARD 2. DATES: The exemptions were issued on TMI-2 Solutions, LLC Sunshine Act Meeting March 9, 2021. Three Mile Island Nuclear Station, ADDRESSES: Please refer to Docket ID Units 1 and 2 Exemptions TIME AND DATE: 9:30 a.m., Tuesday, April NRC–2021–0069 when contacting the I. Background 6, 2021. NRC about the availability of PLACE: Virtual. information regarding this document. By letter dated June 20, 2017 STATUS: The one item may be viewed by You may obtain publicly available (Agencywide Documents Access and the public through webcast only. information related to this document Management System [ADAMS] MATTER TO BE CONSIDERED: using any of the following methods: Accession No. Main Library [ML] 66392 2021–2022 Most Wanted List • Federal Rulemaking website: Go to ML17171A151), Exelon Generation of Transportation Safety https://www.regulations.gov and search Company, LLC (Exelon) certified to the Improvements Proposal. for Docket ID NRC–2021–0069. Address U.S. Nuclear Regulatory Commission FOR MORE INFORMATION CONTACT: Candi questions about Docket IDs in (NRC, the Commission) that it planned Bing at (202) 590–8384 or by email at Regulations.gov to Stacy Schumann; to permanently cease power operations [email protected]. telephone: 301–415–0624; email: at Three Mile Island Nuclear Station, Media Information Contact: Chris [email protected]. For technical Unit 1 (TMI-1) on or about September O’Neil by email at [email protected] questions, contact the individual listed 30, 2019. On September 20, 2019, (202) 314–6100. in the FOR FURTHER INFORMATION Exelon permanently ceased power This meeting will take place virtually. CONTACT section of this document. operations at TMI-1. By letter dated The public may view it through a live • NRC’s Agencywide Documents September 26, 2019 (ADAMS Accession or archived webcast by accessing a link Access and Management System No. ML19269E480), Exelon certified to under ‘‘Webcast of Events’’ on the NTSB (ADAMS): You may obtain publicly the NRC that the fuel was permanently home page at www.ntsb.gov. available documents online in the removed from the TMI-1 reactor vessel There may be changes to this event ADAMS Public Documents collection at and placed in the spent fuel pool (SFP) due to the evolving situation concerning https://www.nrc.gov/reading-rm/ as of September 26, 2019. Accordingly,

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pursuant to Title 10 of the Code of Exelon requested an exemption from 10 III. Discussion Federal Regulations (10 CFR) Section CFR 140.11(a)(4) to reduce the required 50.82(a)(2), the TMI-1 renewed facility level of primary offsite liability Pursuant to 10 CFR 140.8, ‘‘Specific operating license no longer authorizes insurance from $450 million to $100 exemptions,’’ the Commission may, operation of the reactor or emplacement million and to eliminate the upon application of any interested or retention of fuel in the reactor vessel. requirement to carry secondary financial person or upon its own initiative, grant The facility is still authorized to possess protection for TMI-1 and TMI-2 such exemptions from the requirements and store irradiated (i.e., spent) nuclear Solutions, LLC (TMI-2 Solutions) 1 of the regulations in 10 CFR part 140 fuel. Spent fuel is currently stored requested an exemption from 10 CFR when the exemptions are authorized by onsite at the TMI-1 facility in the SFP. 140.11(a)(4) to reduce the required level law and are otherwise in the public Three Mile Island Nuclear Station, of primary offsite liability insurance in interest. The NRC staff has reviewed the Unit 2 (TMI-2) was a 2,770 megawatts the event of an ENO 2 from $200 million licensees’ request for exemptions from thermal pressurized light-water reactor to $100 million for TMI-2. 10 CFR 140.11(a)(4) and has concluded supplied by Babcock & Wilcox that was The regulation at 10 CFR 140.11(a)(4) that the requested exemptions are issued an operating license on February requires each licensee to have and authorized by law and are otherwise in 8, 1978 and began commercial maintain primary financial protection in the public interest. operations on December 30, 1978. On an amount of $450 million. In addition, The Price Anderson Act of 1957 March 28, 1979, TMI-2 experienced an the licensee is required to participate in (PAA) requires that nuclear power accident that resulted in severe damage an industry retrospective rating plan reactor licensees have insurance to to the reactor core. Subsequently, (secondary financial protection) that compensate the public for damages approximately 99 percent of the fuel commits each licensee to pay into an arising from a nuclear incident. and damaged core material was insurance pool to be used for damages Specifically, the PAA requires licensees removed from the TMI-2 reactor vessel that may exceed primary insurance of facilities with a ‘‘rated capacity of and associated systems and shipped to coverage. Participation in the industry 100,000 electrical kilowatts or more’’ to the U.S. Department of Energy Idaho retrospective rating plan will subject the maintain the maximum amount of National Laboratory. After the licensee to deferred premium charges primary offsite liability insurance completion of accident recovery up to a maximum total deferred commercially available (currently $450 operations, TMI-2 was placed in a Post- premium of $131,056,000 with respect million) and a specified amount of Defueling Monitored Storage (PDMS) to any nuclear incident at any operating secondary insurance coverage (currently state on September 14, 1993, with a nuclear power plant and up to a up to $131,056,000 per reactor). In the possession only license that authorizes maximum annual deferred premium of event of an accident causing offsite the possession of byproduct and special $20,496,000 per incident. damages in excess of $450 million, each nuclear materials but not the operation Many of the accident scenarios licensee would be assessed a prorated of the reactor. postulated in the updated safety share of the excess damages, up to Following the TMI-2 accident, in analysis reports for operating power $131,056,000 per reactor, for a total of 1982, the NRC granted an exemption reactors involve failures or malfunctions approximately $13 billion per nuclear from the requirements of 10 CFR of systems, which could affect the fuel incident. The NRC’s regulations at 10 140.11(a)(4) for TMI-1 and TMI-2 in the reactor core and, in the most CFR 140.11(a)(4) implement these PAA (ML19141A211). The exemption severe postulated accidents, would insurance requirements and set forth the allowed the licensees to provide two involve the release of large quantities of amount of primary and secondary endorsements to meet the financial fission products. With the permanent insurance each power reactor licensee protection requirements of subsection cessation of power operations at TMI-1 must have. 170 of the Atomic Energy Act of 1954, and the permanent removal of the fuel as amended. The first endorsement, from the reactor vessel, and the PDMS As noted above, the PAA Endorsement No. 43, restored the limits state of TMI-2 with no fuel assemblies requirements with respect to primary of liability to the amounts listed in other in the TMI-2 reactor or the TMI-2 SFP, and secondary insurance and the endorsements upon an ‘‘extraordinary many accidents are no longer possible. implementing regulations at 10 CFR nuclear occurrence’’ (ENO) being Similarly, the associated risk of offsite 140.11(a)(4) apply to licensees of declared by the NRC arising out of the liability damages that would require facilities with a ‘‘rated capacity of ownership, operation, maintenance, or insurance or indemnification is 100,000 electrical kilowatts or more.’’ In use of TMI-1 and/or TMI-2. The second commensurately lower for such plants. accordance with 10 CFR 50.82(a)(2), the endorsement, Endorsement No. 44, Therefore, Exelon requested an license for a power reactor no longer increased the TMI-1 liability limit to the exemption from 10 CFR 140.11(a)(4) to authorizes operation of the reactor or NRC limit in effect at the time for any permit a reduction in primary offsite emplacement or retention of fuel into bodily injury or property damages liability insurance and to withdraw the reactor vessel upon the docketing of caused by a nuclear energy hazard, but from participation in the industry the certifications for permanent increased the TMI-2 liability limit only retrospective rating plan for TMI-1. cessation of operations and permanent in the event the NRC declared an ENO Additionally, TMI-2 Solutions requested removal of fuel from the reactor vessel, on or after May 1, 1979. Subsequently, an exemption from 10 CFR 140.11(a)(4) or when a final legally effective order to in 1994, the NRC granted TMI-2 an to permit a reduction in primary offsite permanently cease operations has come exemption from participation in liability insurance to $100 million in the into effect. Therefore, the reactor cannot secondary financial protection (ADAMS event of an ENO for TMI-2. be used to generate power. Accession No. 9408050260 [Legacy Accordingly, a reactor that is Library]). The exemptions herein do not 1 The TMI-2 license was transferred to TMI-2 undergoing decommissioning has no impact the exemptions already in place. Solutions on December 18, 2020 (ADAMS ‘‘rated capacity.’’ Thus, the NRC may Accession No. ML20352A381). take the reactor licensee out of the II. Request/Action 2 Pursuant to 10 CFR 140.83, if the Commission determines that both of the criteria set forth in 10 category of reactor licensees that are By letter dated January 3, 2020 CFR 140.84 and 140.85 have been met, it will make required to maintain the maximum (ADAMS Accession No. ML20003E096), the determination that there has been an ENO. available insurance and to participate in

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the secondary retrospective insurance accordance with the Commission’s also evaluated the applicability of other pool. discretionary authority under the PAA design-basis accidents documented in The financial protection limits of 10 to establish an appropriate level of the TMI-1 Updated Final Safety CFR 140.11(a)(4) were established to required financial protection for such Analysis Report (UFSAR) (ADAMS require a licensee to maintain sufficient permanently shut down facilities. Package Accession No. ML18117A343) insurance, as specified under the PAA, The NRC staff has conducted an to ensure that these accidents would not to satisfy liability claims by members of evaluation and concluded that, aside have consequences that could the public for personal injury, property from the handling, storage, and potentially exceed the 10 CFR 50.67 damage, and the legal cost associated transportation of spent fuel and dose limits and Regulatory Guide 1.183, with lawsuits as the result of a nuclear radioactive materials for a permanently ‘‘Alternative Radiological Source Terms accident at an operating reactor with a shut down and defueled reactor, no for Evaluating Design Basis Accidents at rated capacity of 100,000 kilowatts reasonably conceivable potential Nuclear Power Reactors,’’ dose electric or greater. Thus, the insurance accident exists that could cause acceptance criteria or approach the U.S. levels established by this regulation, as significant offsite damage. During Environmental Protection Agency (EPA) required by the PAA, were associated normal power reactor operations, the early phase protective action guides with the risks and potential forced flow of water through the reactor (PAGs). consequences of an accident at an coolant system (RCS) removes heat In the TMI-1 UFSAR, the licensee has operating reactor with a rated capacity generated by the reactor. The RCS determined that 365 days after shut of 100,000 kilowatts electric or greater. transfers this heat away from the reactor down, the FHA doses would decrease to The legal and associated technical core by converting reactor feedwater to a level that would not warrant basis for granting exemptions from 10 steam, which then flows to the main protective actions under the EPA early CFR part 140 is set forth in SECY–93– turbine generator to produce electricity. phase PAG framework, notwithstanding 127, ‘‘Financial Protection Required of Most of the accident scenarios meeting the dose limit requirements Licensees of Large Nuclear Power Plants postulated for operating power reactors under 10 CFR 50.67 and dose During Decommissioning,’’ dated May involve failures or malfunctions of acceptance criteria under Regulatory 10, 1993 (ADAMS Accession No. systems that could affect the fuel in the Guide 1.183. The NRC staff notes that ML12257A628). The legal analysis reactor core, which in the most severe the doses from an FHA are dominated underlying SECY–93–127 concluded postulated accidents would involve the by the isotope Iodine-131. TMI-1 that, upon a technical finding that lesser release of large quantities of fission permanently ceased power operations potential hazards exist after permanent products. With the permanent cessation on September 20, 2019. With 488 days cessation of power operations (and the of reactor operations at the TMI site and of decay, the thyroid dose from an FHA reactor having no ‘‘rated capacity’’), the the permanent removal of the fuel from would be negligible and the only Commission has the discretion under the reactor core, such accidents are no isotope remaining in significant the PAA to reduce the amount of longer possible. The reactor, RCS, and amounts, among those postulated to be insurance required of a licensee supporting systems no longer operate released in a design-basis FHA, would undergoing decommissioning. and have no function related to the be Krypton-85. Since Krypton-85 As a technical matter, the fact that a storage of the irradiated fuel. Therefore, primarily decays by beta emission, the reactor has permanently ceased power postulated accidents involving failure or calculated skin dose from an FHA operations is not itself determinative as malfunction of the reactor, RCS, or analysis would make an insignificant to whether a licensee may cease supporting systems are no longer contribution to the total effective dose providing the offsite liability coverage applicable. equivalent, which is the parameter of required by the PAA and 10 CFR During reactor decommissioning, the interest in the determination of the EPA 140.11(a)(4). In light of the presence of principal radiological risks are early phase PAGs for sheltering or freshly discharged irradiated fuel in the associated with the storage of spent fuel evacuation. The NRC staff concludes SFP at a recently shut down reactor, the onsite. On a case-by-case basis, that the dose consequence from an FHA potential for an offsite radiological licensees undergoing decommissioning for the permanently shut down TMI-1 release from a zirconium fire with have been granted permission to reduce would not approach the EPA early consequences comparable in some the required amount of primary offsite phase PAGs. Therefore, any offsite respects to an operating reactor accident liability insurance coverage from $450 consequence from a design-basis remains. That risk is very low at the million to $100 million and to withdraw radiological release is highly unlikely time of reactor shut down because of from the secondary insurance pool. One and, thus, a significant amount of offsite design provisions that prevent a of the technical criteria for granting the liability insurance coverage is not significant reduction in coolant exemption is that the possibility of a required. inventory in the SFP under normal and design-basis event that could cause The only beyond design-basis event accident conditions and becomes no significant offsite damage has been that has the potential to lead to a longer credible once the continual eliminated. significant radiological release at a reduction in decay heat provides ample In its exemption request, Exelon permanently shut down and defueled time to restore coolant inventory and described both design-basis and beyond- reactor is a zirconium fire. The permits air-cooling in a drained SFP. design-basis events involving irradiated zirconium fire scenario is a postulated, After that time, the probability of a large fuel stored in the TMI-1 SFP. Exelon but highly unlikely, accident scenario offsite radiological release from a stated, and the NRC staff agrees, that that involves the loss of water inventory zirconium fire is negligible for while spent fuel remains in the SFP, the from the SFP resulting in a significant permanently shut down reactors, but the only postulated design-basis accident heat up of the spent fuel and SFP is still operational and an inventory that would remain applicable to TMI-1 culminating in substantial zirconium of radioactive materials still exists in the permanently defueled condition cladding oxidation and fuel damage. onsite. Therefore, an evaluation of the that could contribute a significant dose The probability of a zirconium fire potential for offsite damage is necessary is a fuel handling accident (FHA) in the scenario is related to the decay heat of to determine the appropriate level of Reactor Building, where the SFP is the irradiated fuel stored in the SFP. offsite insurance post shut down, in located. For completeness, the NRC staff Therefore, the risks from a zirconium

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fire scenario continue to decrease as a implementing measures under a an SFP subject to a severe earthquake in function of the time that TMI-1 has been comprehensive general emergency plan. NUREG–2161, ‘‘Consequence Study of a permanently shut down. In this regard, one technical criterion Beyond-Design-Basis Earthquake In the analysis provided in for relieving decommissioning reactor Affecting the Spent Fuel Pool for a U.S. Attachment 2, ‘‘Three Mile Island licensees from the insurance obligations Mark l Boiling Water Reactor,’’ dated Nuclear Station Zirconium Fire applicable to an operating reactor is a September 2014 (ADAMS Accession No. Analysis for Drained Spent Fuel Pool finding that the heat generated by the ML14255A365). This evaluation (Calculation C–1101–202–E410–476, SFP has decayed to the point where the concluded that, for a representative Revision 1),’’ to the letter dated July 1, possibility of a zirconium fire is highly boiling-water reactor, fuel in a dispersed 2019 (ADAMS Accession No. unlikely. This was addressed in SECY– high-density configuration would be ML19182A104), the licensee compared 93–127, where the NRC staff concluded adequately cooled by natural circulation the conditions for the hottest fuel that there was a low likelihood and air flow within several months after assembly stored in the SFP to a criterion reduced short-term public health discharge from a reactor if the pool was proposed in SECY–99–168, ‘‘Improving consequences of a zirconium fire once a drained of water. Decommissioning Regulations for decommissioning plant’s spent fuel has In its exemption request, Exelon Nuclear Power Plants,’’ dated June 30, sufficiently decayed. In its Staff compared TMI-1 fuel storage parameters 1999 (ADAMS Accession No. Requirements Memorandum, ‘‘Financial with those used in NRC generic ML12265A598), applicable to offsite Protection Required of Licensees of evaluations of fuel cooling included in emergency response for the unit in the Large Nuclear Power Plants during NUREG/CR–6451, ‘‘A Safety and decommissioning process. This criterion Decommissioning,’’ dated July 13, 1993 Regulatory Assessment of Generic BWR considers the time for the hottest (ADAMS Accession No. ML003760936), [Boiling-Water Reactor] and PWR assembly to heat up from 30 degrees the Commission approved a policy that ° ° [Pressurized-Water Reactor] Celsius ( C) to 900 C adiabatically. If authorized, through the exemption Permanently Shut down Nuclear Power the heat up time is greater than 10 process, withdrawal from participation Plants,’’ dated August 1997 (ADAMS hours, then offsite emergency in the secondary insurance layer and a Accession No. ML082260098). The preplanning involving the plant is not reduction in commercial liability analysis described in NUREG/CR–6451 necessary. Based on the limiting fuel insurance coverage to $100 million determined that natural air circulation assembly for decay heat and adiabatic when a licensee is able to demonstrate would adequately cool fuel that has heat up analysis presented in that the spent fuel could be air-cooled decayed for 17 months after operation in Attachment 2, at 488 days if the SFP was drained of water. a typical PWR, which is a slightly longer (approximately 16 months) after The NRC staff has used this technical decay time than the zirconium fire permanent cessation of power criterion to grant similar exemptions to period of 488 days on which the TMI- operations, the time for the hottest fuel other decommissioning reactors (e.g., 1 exemption request is based. In order assembly to reach 900 °C is 10 hours Maine Yankee Atomic Power Station, to evaluate if the TMI-1 decay period after the assemblies have been published in the Federal Register (FR) was conservative, Exelon examined the uncovered. As stated in NUREG–1738, on January 19, 1999 (64 FR 2920); Zion decay heat at TMI-1 and determined ‘‘Technical Study of Spent Fuel Pool Nuclear Power Station, published in the that the average fuel assembly decay Accident Risk at Decommissioning Federal Register on December 28, 1999 heat for the most recently offloaded Nuclear Power Plants,’’ dated February (64 FR 72700); Kewaunee Power 2001 (ADAMS Accession No. Station, published in the Federal TMI-1 spent fuel at 488 days after shut ML010430066), 900 °C is an acceptable Register on March 24, 2015 (80 FR down will be approximately 3 percent temperature to use for assessing onset of 15638); Crystal River Unit 3 Nuclear less than the decay heat for the average fission product release under transient Generation Plant, published in the fuel assembly at 519 days for the conditions to establish the critical decay Federal Register on May 6, 2015 (80 FR representative PWR plant in NUREG/ time for determining the availability of 26100); Oyster Creek Nuclear CR–6451. 10 hours for deployment of mitigation Generating Station, published in the A comparison of the parameters for equipment and, if necessary, for offsite Federal Register on December 28, 2018 the fuel assembly power, power density, agencies to take appropriate action to (83 FR 67365); and Pilgrim Nuclear and hydraulic resistance of the 15x15 protect the health and safety of the Power Station, published in the Federal fuel assemblies at TMI-1 indicated that public if fuel and cladding oxidation Register on January 13, 2020 (85 FR these parameters are less than those of occurs in air. 1827)). the 17x17 fuel assemblies modeled in The NRC staff reviewed the Additional discussions of other NUREG/CR–6451. Therefore, the calculation to verify that important decommissioning reactor licensees that NUREG/CR–6451 fuel assembly model physical properties of materials were have received exemptions to reduce is conservative for TMI-1. The SFP rack within acceptable ranges and the results their primary insurance level to $100 configuration was also evaluated and were accurate. The NRC staff million are provided in SECY–96–256, found to be conservative for TMI-1. The determined that physical properties ‘‘Changes to the Financial Protection configuration/hydraulic resistance of were appropriate and completed Requirements for Permanently the TMI-1 downcomers and plenum independent confirmatory calculations Shutdown Nuclear Power Reactors, 10 underneath the SFP storage racks is that produced similar results. Therefore, CFR 50.54(w) and 10 CFR 140.11,’’ bounded by that modeled in NUREG/ the NRC staff found that after 488 days dated December 17, 1996 (ADAMS CR–6451. Additionally, the hydraulic of decay, at least 10 hours would be Accession No. ML15062A483). These resistance of the SFP rack loaded cells available before a significant offsite prior exemptions were based on the is less than that of the SFP rack release could begin. The NRC staff licensee demonstrating that the SFP configuration modeled in NUREG/CR– concluded that the adiabatic heat up could be air-cooled consistent with the 6451. The bottom orifices on all TMI-1 calculation provided an acceptable technical criterion discussed above. SFP racks are equal to or larger than method for determining the minimum The NRC staff has evaluated the issue those modeled in NUREG/CR–6451, time available for deployment of of zirconium fires in SFPs and which also makes the estimates for mitigation equipment and, if necessary, presented an independent evaluation of TMI-1 more conservative.

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As a result of the comparison, Exelon CR–6451 benchmark demonstrating that and defueled power reactors upon concluded that the TMI-1 SFP the SFP would be air-coolable at 488 satisfactory demonstration that conditions are bounded by the days after permanent cessation of zirconium fire risk from the irradiated NUGREG/CR–6451 benchmark and that operations. fuel stored in the SFP is of negligible the TMI-1 spent fuel would be air- In its exemption request, Exelon concern. coolable at 488 days after permanent furnished the following information: As provided in SECY–93–127, the shut down. Therefore, at 16 months ‘‘Because of the length of time it would NRC staff included in its after permanent shut down, the NRC take for the adiabatic heat up to occur, recommendations that using the staff has reasonable assurance that fuel there is ample time to respond (≥10 standards set forth in SECY–93–127, stored in the TMI-1 SFP would be hours) to any drain down event that primary financial protection could be adequately air-cooled in the unlikely might cause such an occurrence by reduced to $100 million for nuclear event the SFP completely drained. restoring [SFP] cooling or makeup or power plants that have had the requisite In SECY–00–0145, ‘‘Integrated providing [SFP] spray. As a result, the spent fuel cooling period. However, as Rulemaking Plan for Nuclear Power likelihood that such a scenario would specifically mentioned in SECY–93–127 Plant Decommissioning,’’ dated June 28, progress to a zirconium fire is not (Note 5), for TMI-2 ‘‘primary financial 2000, and SECY–01–0100, ‘‘Policy deemed credible.’’ protection covering the site will remain Issues Related to Safeguards, Insurance, In the NRC staff’s evaluation at $200 million [the full required and Emergency Preparedness contained in SECY–20–0041, ‘‘Request regulatory value at the time of the Regulations at Decommissioning by Exelon Generation Company, LLC for issuance of SECY–93–127] because Nuclear Power Plants Storing Fuel in Exemptions from Certain Emergency there is at least one other operating Spent Fuel Pools,’’ dated June 4, 2001 Planning Requirements for the Three reactor on [the] site.’’ Since TMI-1 is no (ADAMS Accession Nos. ML003721626 Mile Island Nuclear Station,’’ dated May longer authorized to operate, there is no and ML011450420, respectively), the 5, 2020 (ADAMS Accession No. longer at least one other operating NRC staff discussed additional ML19311C763), the NRC staff assessed reactor on the TMI site. Therefore, information concerning SFP zirconium the Exelon accident analyses associated TMI-2 Solutions requested a fire risks at decommissioning reactors with the radiological risks from a corresponding exemption from 10 CFR and associated implications for offsite zirconium fire at a permanently shut 140.11(a)(4) for TMI-2 to permanently insurance. Analyzing when the spent down and defueled TMI site. For the reduce the required level of primary fuel stored in the SFP is capable of highly unlikely beyond design-basis offsite liability insurance for ENOs from adequate air-cooling is one measure that accident scenario where the SFP coolant $200 million to $100 million. As demonstrates when the probability of a inventory is lost in such a manner that discussed above, TMI-2 is maintained in zirconium fire would be exceedingly all methods of heat removal from the a PDMS state with a possession only low. spent fuel are no longer available, the license that authorizes the possession of In addition, the licensee performed NRC staff found that there will be a byproduct and special nuclear materials adiabatic heat up analyses to determine minimum of 10 hours from the but not the operation of the reactor. a dose rate curve at the Exclusion Area initiation of the accident until the The NRC staff evaluated the Boundary (EAB) and Control Room. cladding reaches a temperature where applicability of a waste gas tank rupture Although the analysis described above offsite radiological release might occur. as documented in the TMI-1 UFSAR, demonstrated that a significant release The NRC staff finds that 10 hours is and the applicability of any of radioactive material from the spent sufficient time to support deployment of unanticipated releases as documented fuel in the absence of water cooling is mitigation equipment, consistent with in the Unanticipated Events Analysis in not possible after 488 days following plant conditions, to prevent the the TMI-2 Post-Defueling Monitored permanent cessation of power zirconium cladding from reaching a Storage Safety Analysis Report (ADAMS operations, the potential exists for point of rapid oxidation. Package Accession No. ML17236A295), radiation exposure to an offsite The NRC staff has determined that the to ensure that these accidents would not individual in the event that shielding of licensee’s proposed reduction in have consequences that could the fuel is lost. The site-specific offsite primary offsite liability coverage to a potentially exceed the 10 CFR 50.67 and Control Room radiological impacts level of $100 million and the licensee’s dose limits and Regulatory Guide 1.183 of a postulated complete loss of SFP proposed withdrawal from participation dose acceptance criteria or approach the water were assessed in TMI-1 Technical in the secondary insurance pool for EPA early phase PAGs. Exelon stated Evaluation 623073, ‘‘TMI Spent Fuel offsite financial protection are that the bounding event for TMI-2 is a Pool Draindown Shine Dose Rate consistent with the policy established in fire in the Reactor Building with the Evaluation, Revision 0.’’ With a decay of SECY–93–127 and subsequent Reactor Building Purge System in 365 days from shut down, the dose rate insurance considerations resulting from operation. The NRC staff reviewed the at the EAB would be 4.04 × 10¥1mrem/ zirconium fire risks, as discussed in assumptions, inputs, and methods used hour not crediting the shielding from SECY–00–0145 and SECY–01–0100. by Exelon to assess the radiological the Fuel Handling Building (FHB) roof. The NRC has previously determined in impacts of the requested exemption. Crediting the FHB roof structure, the SECY–00–0145 that the minimum The NRC staff concludes that Exelon has dose rate at the EAB would be 4.6 × offsite financial protection requirement demonstrated that the dose 10¥10 mrem/hour. may be reduced to $100 million and that consequences for postulated accidents The licensee’s adiabatic heat up secondary insurance is not required at the permanently defueled TMI facility analyses demonstrate that 16 months once it is determined that the spent fuel would not have consequences that after the permanent cessation of in the SFP is no longer thermal- could potentially exceed the applicable operations, there would be at least 10 hydraulically capable of sustaining a dose limits in 10 CFR 100.11, hours to take mitigative actions in zirconium fire based on a plant-specific ‘‘Determination of exclusion area, low response to events that could lead to a analysis. In addition, the NRC staff population zone, and population center zirconium fire. In addition, the TMI-1 notes that similar exemptions from distance,’’ and 10 CFR 50.67, and the SFP conditions were determined to be these insurance requirements have been dose acceptance criteria in Regulatory bounded by the analysis of the NUREG/ granted to other permanently shut down Guide 1.183. The analysis demonstrates

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that 365 days after permanent cessation analysis underlying SECY–93–127 requirements to carry the maximum of power operations, the radiological concluded that, upon a technical amount of insurance available and to consequences of the analyzed design- finding that lesser potential hazards participate in the secondary basis accidents will not exceed the exist after permanent cessation of retrospective premium pool where there limits of the EPA early phase PAGs at operations, the Commission has the is sufficient technical justification, the the EAB. Therefore, the NRC staff finds discretion under the PAA to reduce the NRC staff concludes that the requested the requested exemption to be amount of insurance required of a exemptions are authorized by law. acceptable from a dose consequence licensee undergoing decommissioning. B. The Exemptions Are Otherwise in the perspective. Based on its review of the exemption The most significant accident requests, the NRC staff concludes that Public Interest sequence for a permanently defueled the technical criteria for relieving The financial protection limits of 10 and shut down reactor involves the Exelon and TMI-2 Solutions from their CFR 140.11 were established to require complete loss of water from the spent existing primary and/or secondary licensees to maintain sufficient offsite fuel pool. As the NRC previously insurance obligations have been met. As liability insurance to ensure adequate recognized when issuing an exemption explained above, the NRC staff found funding for offsite liability claims for TMI-2 from the requirement to that no reasonably conceivable design- following an accident at an operating participate in secondary financial basis accident exists that could cause an reactor. However, the regulation does protection, this accident scenario is not offsite release greater than the EPA not consider the reduced potential for credible or reasonably conceivable at PAGs and, therefore, that any offsite and consequence of nuclear incidents at TMI-2 since the spent fuel pool is consequence from a design-basis permanently shut down and drained and no spent fuel is stored in radiological release is highly unlikely decommissioning reactors. the pool. Since TMI-2 is being and the need for a significant amount of The basis provided in SECY–93–127, maintained in a PDMS state with the offsite liability insurance coverage is SECY–00–0145, and SECY–01–0100 reactor defueled and no fuel in the unwarranted. Additionally, the NRC allows licensees of decommissioning TMI-2 SFP, TMI-2 meets the criterion staff determined that, after 16 months plants to reduce their primary offsite established in SECY–93–127 for relief decay, the fuel stored in the TMI-1 SFP liability insurance and to withdraw from the requirements to maintain will be capable of being adequately from participation in the retrospective primary offsite liability insurance for cooled by air in the highly unlikely rating pool for deferred premium ENOs at a level above $100 million. As event of pool drainage. Moreover, in the charges. As discussed in these discussed previously, TMI-2 has already highly unlikely beyond design-basis documents, once the zirconium fire received an exemption from accident scenario where the SFP coolant concern is determined to be negligible, participation in the secondary inventory is lost in such a manner that possible accident scenario risks at retrospective insurance pool. Because all methods of heat removal from the permanently shut down and defueled the criteria presented in SECY–93–127 spent fuel are no longer available, the reactors are greatly reduced when for removal from the secondary NRC staff has determined that at least 10 compared to the risks at operating financial protection requirement are hours would be available and is reactors and the associated potential for identical to those for reducing the sufficient time to support deployment of offsite financial liabilities from an primary offsite liability insurance, there mitigation equipment, consistent with accident are commensurately less. The is precedent for allowing the reduction plant conditions, to prevent the licensee analyzed and the NRC staff of offsite liability insurance for TMI (as zirconium cladding from reaching a confirmed that the risks of accidents a site), once TMI-1 has met the criteria point of rapid oxidation. Thus, the NRC that could result in an offsite in SECY–93–127. In addition, the NRC staff concludes that the fuel stored in radiological risk are minimal, thereby staff notes that similar exemptions from the TMI-1 SFP will have decayed justifying the proposed reductions in these insurance requirements have been sufficiently by the requested effective offsite primary liability insurance and granted to other permanently shut down date for the exemptions of 16 months withdrawal from participation in the and defueled power reactors, upon after permanent cessation of power secondary retrospective rating pool for satisfactory demonstration that operations to support a reduction in the deferred premium charges. zirconium fire risk from the irradiated required insurance consistent with Additionally, participation in the fuel stored in the SFP is of negligible SECY–00–0145. Moreover, since the secondary retrospective rating pool concern. criteria presented in SECY–93–127 for could potentially have adverse removal from the secondary financial consequences on the safe and timely A. The Exemptions Are Authorized by protection requirement are identical to completion of decommissioning. If a Law those for reducing the primary offsite nuclear incident sufficient to trigger the The PAA and its implementing liability insurance, there is precedent secondary insurance layer occurred at regulations in 10 CFR 140.11(a)(4) for allowing the reduction of offsite another nuclear power plant, the require licensees of nuclear reactors that liability insurance for TMI (as a site), licensee could incur financial liability have a rated capacity of 100,000 once TMI-1 has met the criteria in of up to $131,056,000. However, kilowatts electric or more to have and SECY–93–127. because TMI is permanently shut down, maintain $450 million in primary The NRC staff has determined that it cannot produce revenue from financial protection and to participate in granting the licensees’ proposed electricity generation sales to cover such a secondary retrospective insurance exemptions will not result in a violation a liability. Therefore, such liability if pool. In accordance with 10 CFR 140.8, of the Atomic Energy Act of 1954, subsequently incurred could the Commission may grant exemptions Section 170, or other laws, as amended, significantly affect the ability of the from the regulations in 10 CFR part 140 which require licensees to maintain facility to conduct and complete timely as the Commission determines are adequate financial protection. radiological decontamination and authorized by law. The legal and Accordingly, consistent with the legal decommissioning activities. In addition, associated technical basis for granting standard presented in SECY–93–127, as SECY–93–127 concluded, the shared exemptions from 10 CFR part 140 are set under which decommissioning reactor financial risk exposure to the licensee is forth in SECY–93–127. The legal licensees may be relieved of the greatly disproportionate to the

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radiological risk posed by TMI when potential for or consequences from 140.11(a)(4) permit TMI-1 to reduce the compared to operating reactors. The radiological accidents; and (vi) the required level of primary financial reduced overall risk to the public at requirements from which an exemption protection from $450 million to $100 decommissioning power plants does not is sought involve surety, insurance, or million and to withdraw from warrant that the licensee be required to indemnity requirements. participation in the secondary layer of carry full operating reactor insurance As the Director, Division of financial protection 16 months after the coverage after the requisite spent fuel Decommissioning, Uranium Recovery, permanent cessation of power cooling period has elapsed following and Waste Programs, Office of Nuclear operations. Further, the exemptions final reactor shut down. The licensee’s Material Safety and Safeguards, I have permit TMI-2 relief from the proposed financial protection limits will determined that approval of the requirements to maintain primary offsite maintain a level of liability insurance exemption request involves no liability insurance for ENOs at a level coverage commensurate with the risk to significant hazards consideration, as above $100 million. the public. These changes are consistent defined in 10 CFR 50.92, because The exemptions are effective as of 16 with previous NRC policy as discussed reducing a licensee’s offsite liability months after permanent cessation of in SECY–00–0145 and exemptions requirements at TMI does not: (1) power operations. approved for other decommissioning Involve a significant increase in the reactors. Thus, the underlying purpose probability or consequences of an Dated, this 9th day of March, 2021. of the regulations will not be adversely accident previously evaluated; (2) create For the Nuclear Regulatory Commission. affected by the reductions in insurance the possibility of a new or different kind Patricia K. Holahan, coverage. Accordingly, an exemption of accident from any accident Director, Division of Decommissioning, from participation in the secondary previously evaluated; or (3) involve a Uranium Recovery, and Waste Programs, insurance pool (for TMI-1) and a significant reduction in a margin of Office of Nuclear Material Safety and reduction in the primary insurance to safety. The exempted financial Safeguards. $100 million (for TMI-1 and TMI-2), a protection regulation is unrelated to the [FR Doc. 2021–05396 Filed 3–15–21; 8:45 am] value more in line with the potential operation of TMI or site activities. BILLING CODE 7590–01–P consequences of accidents, would be in Accordingly, there is no significant the public interest in that this ensures change in the types or significant that there will be adequate funds to increase in the amounts of any effluents address any of those consequences and that may be released offsite and no SECURITIES AND EXCHANGE helps to ensure the safe and timely significant increase in individual or COMMISSION decommissioning of the reactor. cumulative public or occupational Therefore, the NRC staff has radiation exposure. The exempted [Release No. 34–91290; File No. SR–ICEEU– concluded that the requested regulation is not associated with 2021–007] exemptions from 10 CFR 140.11(a)(4) at construction so there is no significant the requested effective date of 16 construction impact. The exempted Self-Regulatory Organizations; ICE months after the permanent cessation of regulation does not concern the source Clear Europe Limited; Notice of Filing power operations, are in the public term (i.e., potential amount of radiation and Immediate Effectiveness of interest. in an accident) nor any activities Proposed Rule Change Relating to conducted at the site. Therefore, there is Amendments to the ICE Clear Europe C. Environmental Considerations no significant increase in the potential Futures and Options Risk Policy and The NRC’s approval of an exemption for, or consequences of, a radiological Futures and Options Risk Procedures from insurance or indemnity accident. In addition, there would be no and Retirement of the Futures and requirements belongs to a category of significant impacts to biota, water Options Concentration Charge Policy actions that the Commission, by rule or resources, historic properties, cultural regulation, has declared to be a resources, or socioeconomic conditions March 10, 2021. categorical exclusion after first finding in the region resulting from issuance of Pursuant to Section 19(b)(1) of the that the category of actions does not the requested exemptions. The Securities Exchange Act of 1934 individually or cumulatively have a requirement for offsite liability (‘‘Act’’),1 and Rule 19b–4 thereunder,2 significant effect on the human insurance involves surety, insurance, or notice is hereby given that on March 3, environment. Specifically, the indemnity matters only. 2021, ICE Clear Europe Limited (‘‘ICE exemption is categorically excluded Therefore, pursuant to 10 CFR Clear Europe’’ or the ‘‘Clearing House’’) from the requirement to prepare an 51.22(b) and 51.22(c)(25), no filed with the Securities and Exchange environmental assessment or environmental impact statement or Commission (‘‘Commission’’) the environmental impact statement in environmental assessment need be proposed rule changes described in accordance with 10 CFR 51.22(c)(25). prepared in connection with the Items I, II, and III below, which Items Under 10 CFR 51.22(c)(25), granting approval of this exemption request. have been prepared primarily by ICE of an exemption from the requirements Clear Europe. ICE Clear Europe filed the IV. Conclusions of any regulation of Chapter I to 10 CFR proposed rule change pursuant to is a categorical exclusion provided that: Accordingly, the Commission has Section 19(b)(3)(A) of the Act 3 and Rule (i) There is no significant hazards determined that, pursuant to 10 CFR 19b–4(f)(4)(ii) 4 thereunder, such that consideration; (ii) there is no significant 140.8, the requested exemptions are the proposed rule was immediately change in the types or significant authorized by law and are otherwise in effective upon filing with the increase in the amounts of any effluents the public interest. Therefore, the Commission. The Commission is that may be released offsite; (iii) there is Commission hereby grants Exelon and publishing this notice to solicit no significant increase in individual or TMI-2 Solutions exemptions from the cumulative public or occupational requirements of 10 CFR 140.11(a)(4) for 1 15 U.S.C. 78s(b)(1). radiation exposure; (iv) there is no the TMI site. TMI-1 permanently ceased 2 17 CFR 240.19b–4. significant construction impact; (v) power operations on September 20, 3 15 U.S.C. 78s(b)(3)(a). there is no significant increase in the 2019. The exemptions from 10 CFR 4 17 CFR 240.19b–4(f)(4)(ii).

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comments on the proposed rule change amendments would result in the retiring 80%. Any correction to the promoted from interested persons. of ICE Clear Europe’s F&O rates would be made at such point. The Concentration Charge Policy as the F&O summary table of the review and I. Clearing Agency’s Statement of the Risk Policy and F&O Risk Procedures promotion process for IRM margin rate Terms of Substance of the Proposed (as amended) would render such Future parameters would be updated to reflect Rule Change and Options Concentration Charge the Clearing House’s current practices The principal purpose of the Policy redundant. with respect to the testing and proposed amendments is for ICE Clear frequency of testing for such IRM Europe to (i) modify its Futures and I. Futures and Options Risk Policy margin rate parameters. Specifically, Options Risk Policy (the ‘‘F&O Risk The Policy would be revised to daily checks flagging any difference Policy’’) and Futures and Options Risk remove section 2.2.6, which describes between production rate and AP rate Procedures (the ‘‘F&O Risk Procedures’’ the capital to margin ratio, from the using a threshold of 20% where AP is or the ‘‘Procedures’’) to update certain additional margin requirements larger than production would be used. aspects of the F&O initial margin discussion. The description is being Additionally, monthly checks would methodology, including with respect to removed as the ratio is not in itself flag any difference between production the capital to margin ratio, use of necessarily the basis of additional rate and AP rate for material parameters delivery margin, calculation of net margin requirements and is addressed using a threshold of 20% relative liquidating value and certain buffers, in other existing ICE Clear Europe difference where AP is larger than and (ii) retire its Futures and Options policies and procedures. This production scanning rate, and 20% Concentration Charge Policy (‘‘F&O amendment does not reflect a change in absolute difference where production is Concentration Charge Policy’’) once Clearing House practice or margin larger than AP ICS rate. such proposed amendment are made, as methodology. Certain minor non- Parameter Review and Recalibration such policy would be made redundant substantive typographical updates as a result of the proposed amendments. would also be made to the Policy. The amendments would clarify that exceptions driving an ad hoc review and II. Clearing Agency’s Statement of the II. F&O Risk Procedures parameter recalibration would be Purpose of, and Statutory Basis for, the IRM Margin Rate Parameters subject to notification to the Risk Proposed Rule Change Oversight Department (‘‘ROD’’) in Amendments to the Procedures would addition to Senior CRD (director or In its filing with the Commission, ICE update the standard parameters for daily above) decision. This clarification Clear Europe included statements calculation of the calibrated IM rate (the would be made throughout the concerning the purpose of and basis for so-called ‘‘Autopilot’’ or ‘‘AP’’ rate) to Procedures with respect to parameter the proposed rule change and discussed reference inter-contract volatility review and recalibration. any comments it received on the spreads. The amendments would update proposed rule change. The text of these and clarify certain processes for the IRM Parameterization statements may be examined at the routine periodic review of the places specified in Item IV below. ICE This section would be amended to production margin rate (which is the correctly reference relevant model Clear Europe has prepared summaries, actual rate used in the margin set forth in sections (A), (B), and (C) documentation. The summary of the calculation generating CMs’ Core IM review process would be updated to add below, of the most significant aspects of requirements, and is typically based on such statements. that ad hoc reviews would be triggered the Autopilot rate). Specifically, the by large deviations in the daily (A) Clearing Agency’s Statement of the amendments would clarify that details sensitivity report. Purpose of, and Statutory Basis for, the of proposed parameters and margin Proposed Rule Change impact along with justification for any Additional Initial Margin manual overrides from the Autopilot Amendments to the section of the (a) Purpose rate would need to be approved by the Procedures relating to concentration ICE Clear Europe is proposing to CRO and the President of ICEU or their charges would update the testing revise the F&O Policy to remove the deputies. The amendments would frequency for product review and group description of the capital to margin ratio provide that the CRD can inform mapping requirements from at least as a basis for requesting additional exchange staff (instead of sales staff) at annually to monthly for a subset of initial margin or a reduction in its discretion for information about the products, and otherwise quarterly. positions to reduce the required initial margin update. The amendments would With respect to the Stress Margin or margin level. also remove a process for the CRD to Stress Loss Charge (‘‘SLC’’) additional ICE Clear Europe is also proposing to receive feedback on proposed Initial Margin calculation methodology, amend its F&O Procedures to (i) update parameters by sales staff or the Procedures would update the testing certain processes, escalations and management, which the Clearing House and frequency with respect to the SLC controls with respect to the review of views as unnecessary in light of the process from no specific test to provide the IRM margin rate parameters, (ii) procedures for senior management for Daily Cover 1 and Cover 2 tests update the existing descriptions of approval. where the largest uncollateralized stress review and testing processes for Furthermore, the amendments would loss of a single member and pair of additional margin calculation provide that upon review and approval members, respectively, is determined. methodologies, (iii) add a description of of specific Senior Management Team Any SLC top up would be called from the Clearing House’s use of delivery members, the CRD would promote the the member. Furthermore, with respect margin, net liquidating value, intraday rates into the risk system. The CRD to the SLC process for stress scenarios buffers, overnight buffers, and ad hoc would refresh the Product Report to and proxy mapping, the amendments buffers as margin calculation perform a check on the rates to go live. would update the frequency of review to methodologies and (iv) make various One such check would be to ensure no provide that PCA EVT scenarios (i.e., other drafting clarifications and cross-asset class inter-commodity those combining principal component improvements. These proposed spread (ICS) parameters are larger than analysis and extreme value theory)

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would be reviewed at least quarterly. against the margin account for the manage the risk of losses resulting from Monthly testing with respect to PCA remainder of the open position. The defaulting Clearing Members’ portfolios. EVT monitoring would be reported to level of NLV credit/debit would be The amendments would update and the MOC. recalculated each day according to the clarify the processes, controls and The amendments would update the option settlement price and any top up escalations with respect to the testing description of F&O guarantee fund (GF) would be called the following day. A and reviewing Clearing Members’ Initial requirements to clarify that GF size summary table of the details of the NLV Margin requirements and related corresponds to the maximum of the determination would be included. parameters. The amendments would largest cover 2 loss over the last month The updates to the Procedures would also more clearly describe certain types or the average cover two losses over the add a new section regarding ‘‘Intraday of additional margin and calculation last three months plus one standard and Overnight Buffer’’, which would methodologies, and clarify the deviation. This change conforms to summarize the existing ability of procedures for the testing and review current practice and does not reflect a Clearing Members to post an additional thereof. Through better managing risks change in methodology. buffer each day to offset intraday margin in default scenarios and promoting Regarding the Clearing House’s shortfall. The provisions would market stability, the proposed Wrong-Way Risk (WWR) Requirements, reference existing descriptions of amendments would promote the the amendments would update the intraday and overnight buffers in the stability of the Clearing House and the testing/frequency of the WWR process Procedures. A summary table of the prompt and accurate clearance and to add that index weights would be intraday and overnight buffers would settlement of cleared contracts. The reviewed quarterly. also be included. enhanced risk management is therefore With respect to the EMIR add-on Finally, the updates to the Procedures also generally consistent with the calculation methodology, the testing would add a new section describing protection of investors and the public frequency would be updated to provide ‘‘Ad-Hoc Buffer’’, which would state interest in the safe operation of the for monthly backtesting on benchmark that Clearing Members may be requested Clearing House. (ICE Clear Europe products using a one-day margin period to post additional buffers for various would not expect the amendments to of risk and a daily check for benchmark risks not otherwise covered in the affect the safeguarding of securities and products using a two-day margin period Procedures. Such requirements would funds in ICE Clear Europe’s custody or of risk. Ad hoc review would be be set by the Risk Senior Management control or for which it is responsible.) dependent on test results, margin and the Credit Risk team. A summary Accordingly, the amendments satisfy behavior during high volatility periods, table of the ad-hoc buffer would be the requirements of Section and market expert feedback, rather than included. The amendments are intended 17A(b)(3)(F).7 being only applicable for H and F to describe more clearly an existing The amendments are also consistent accounts. authority of the Clearing House. with relevant provisions of Rule 17Ad– The updates to the procedures would 22. Rule 17Ad–22(e)(3)(i) 8 requires add a new section addressing ‘‘Delivery Other General Drafting Clarifications clearing agencies to maintain a sound Margins’’, which would add a and Improvements risk management framework that description of the Clearing House’s The amendments would define identifies, measures, monitors and existing use of delivery margins to previously undefined terms such as manages the range of risks that it faces. mitigate any payment or delivery risks ‘‘CRO’’ (Chief Risk Officer). Various The amendments to the F&O Risk Policy during the delivery timeline of typographical and similar corrections and the F&O Risk Procedures are physically delivered products. Such would also be made throughout the intended to better reflect margin and delivery margins include: (i) Delivery Procedures. guaranty fund methodologies that margin, which is designed to cover any calibrate resources held by ICE Clear (b) Statutory Basis price movement on the product in Europe to the risks faced by the Clearing delivery, (ii) buyer security, which is ICE Clear Europe believes that the House, through improvements to the the notional value of the prompt portion proposed amendments to the F&O Risk description and review and testing of of the contract in delivery, (iii) seller Policy and the F&O Risk Procedures are relevant methodologies. The security, which is the additional charge consistent with the requirements of amendments will thus strengthen the on the seller to cover the situation Section 17A of the Act 5 and the management of default risks, and risk where the seller is unable to deliver regulations thereunder applicable to it. management more generally. In ICE agreed product, and (iv) contingent In particular, Section 17A(b)(3)(F) of the Clear Europe’s view, the amendments variation margin, collected against Act 6 requires, among other things, that are therefore consistent with the difference between spot price and end the rules of a clearing agency be requirements of Rule 17Ad–22(e)(3)(i).9 of day settlement price between the last designed to promote the prompt and Rule 17Ad–22(e)(6)(i) 10 requires a trading day and collection of buyer’s accurate clearance and settlement of covered clearing agency to consider and security. The amended Procedures securities transactions and, to the extent produce margin levels commensurate would also include a summary table applicable, derivative agreements, with, the risks and particular attributes that describes details of the delivery contracts, and transactions, the of each relevant product, portfolio, and margin, buyer/seller security, and safeguarding of securities and funds in market. The proposed amendments contingent variation margin. the custody or control of the clearing update the existing descriptions of The amendments to the Procedures agency or for which it is responsible, calculation methodologies for additional would also add a new section describing and the protection of investors and the margin to provide further detail, the Clearing House’s existing practices public interest. including with respect to ongoing regarding net liquidating value of The proposed changes to the F&O testing and review processes. The certain ‘‘equity-style’’ margined F&O Procedures and F&O Policy are designed options. For such options, the option to strengthen ICE Clear Europe’s tools to 7 15 U.S.C. 78q–1(b)(3)(F). premium must be paid/received at 8 17 CFR 240.17 Ad–22(e)(3)(i). inception of the trade and the daily 5 15 U.S.C. 78q–1. 9 17 CFR 240.17 Ad–22(e)(3)(i). option value held as a credit or debit 6 15 U.S.C. 78q–1(b)(3)(F). 10 17 CFR 240.17Ad–22(e)(6)(i).

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amendments further add a description responsibility. The proposed action is necessary or appropriate in the of the Clearing House’s existing use of amendments to the Procedures would public interest, for the protection of delivery margin, net liquidating value, update the processes for the review of investors, or otherwise in furtherance of intraday buffers, overnight buffers, and the relevant parameters to clarify the the purposes of the Act. ad hoc buffers. These amendments thus role of the CRD and deputies of the IV. Solicitation of Comments enhance the clarity of ICE Clear Chief Risk Officer and the President of Europe’s overall margin framework and the Clearing House. They would also Interested persons are invited to documentation, and facilitate describe for the role of Senior submit written data, views, and compliance with the requirements of Management Team members and the arguments concerning the foregoing, Rule 17Ad–22(e)(6)(i).11 Risk Oversight Department in this including whether the proposed rule Rule 17Ad–22(e)(6)(vi)(A) and (B) 12 process. In ICE Clear Europe’s view, the change is consistent with the Act. requires that a clearing agency cover its amendments are therefore consistent Comments may be submitted by any of credit exposures to its participants by with the requirements of Rule 17Ad– the following methods: establishing a risk-based margin system 22(e)(2).17 Electronic Comments that is monitored by management and • regularly reviewed by ‘‘(A) [c]onducting (B) Clearing Agency’s Statement on Use the Commission’s internet backtests of its margin model at least Burden on Competition comment form (http://www.sec.gov/ once each day using standard ICE Clear Europe does not believe the rules/sro.shtml) or • Send an email to rule-comments@ predetermined parameters and proposed amendments would have any sec.gov. Please include File Number SR– assumptions’’ and ‘‘(B) [c]onducting a impact, or impose any burden, on ICEEU–2021–007 on the subject line. sensitivity analysis of its margin model competition not necessary or and a review of its parameters and appropriate in furtherance of the Paper Comments assumptions for backtesting on at least purposes of the Act. The amendments • Send paper comments in triplicate a monthly basis . . .’’ The proposed are being adopted to update and clarify to Secretary, Securities and Exchange amendments describing the EMIR the F&O Risk Policy and the F&O Risk Commission, 100 F Street NE, margin add-on methodology provide for Procedures and will apply to all F&O Washington, DC 20549–1090. Clearing Members. The proposed monthly backtesting on 1-day margin All submissions should refer to File amendments are not expected to period of risk benchmark products using Number SR–ICEEU–2021–007. This file materially change F&O Guaranty Fund predetermined parameters and a daily number should be included on the Contributions or margin requirements check for other products. In ICE Clear subject line if email is used. To help the for F&O Clearing Members. ICE Clear Europe’s view, these amendments are Commission process and review your Europe does not believe the therefore consistent with the comments more efficiently, please use amendments would affect the costs of requirements of Rule 17Ad– only one method. The Commission will 13 clearing, the ability to market 22(e)(6)(vi)(A) and (B). post all comments on the Commission’s 14 participants to access clearing, or the Rule 17Ad–22(e)(4)(v) requires a internet website (http://www.sec.gov/ market for clearing services generally. covered clearing agency to maintain rules/sro.shtml). Copies of the Therefore, ICE Clear Europe does not financial resources that would at a submission, all subsequent believe the proposed rule change minimum enable it to cover a wide amendments, all written statements imposes any burden on competition that range of foreseeable stress scenarios that with respect to the proposed rule is inappropriate in furtherance of the include, but are not limited to, the change that are filed with the purposes of the Act. default of the two participant families Commission, and all written that would potentially cause the largest (C) Clearing Agency’s Statement on communications relating to the aggregate credit exposure for the Comments on the Proposed Rule proposed rule change between the covered clearing agency in extreme but Change Received From Members, Commission and any person, other than plausible market conditions. The Participants or Others those that may be withheld from the amendments to the Procedures are Written comments relating to the public in accordance with the consistent with this requirement by provisions of 5 U.S.C. 552, will be providing that the GF size corresponds proposed amendments have not been solicited or received by ICE Clear available for website viewing and to the maximum of the largest cover 2 printing in the Commission’s Public loss over the last month or the average Europe. ICE Clear Europe will notify the Commission of any written comments Reference Room, 100 F Street NE, cover 2 two losses over the last three Washington, DC 20549, on official months plus one standard deviation. In received with respect to the proposed rule change. business days between the hours of ICE Clear Europe’s view, these 10:00 a.m. and 3:00 p.m. Copies of such amendments are therefore consistent III. Date of Effectiveness of the filings will also be available for with the requirements of Rule 17Ad– Proposed Rule Change and Timing for 15 inspection and copying at the principal 22(e)(4)(v). Commission Action office of ICE Clear Europe and on ICE Rule 17Ad–22(e)(2) 16 requires Clear Europe’s website at https:// clearing agencies to establish reasonably The foregoing rule change has become www.theice.com/notices/ designed policies and procedures to effective pursuant to Section 19(b)(3)(A) 18 Notices.shtml?regulatoryFilings. provide for governance arrangements of the Act and paragraph (f) of Rule 19b–4 19 thereunder. At any time within All comments received will be posted that are clear and transparent and without change. Persons submitting specify clear and direct lines of 60 days of the filing of the proposed rule change, the Commission summarily may comments are cautioned that we do not redact or edit personal identifying 11 17 CFR 240.17Ad–22(e)(6)(i). temporarily suspend such rule change if 12 17 CFR 240.17Ad–22(e)(6)(vi)(A) and (B). it appears to the Commission that such information from comment submissions. 13 17 CFR 240.17Ad–22(e)(6)(vi)(A) and (B). You should submit only information 14 17 CFR 240.17 Ad–22(e)(4)(v). 17 17 CFR 240.17 Ad–22(e)(2). that you wish to make available 15 17 CFR 240.17 Ad–22(e)(4)(v). 18 15 U.S.C. 78s(b)(3)(A). publicly. All submissions should refer 16 17 CFR 240.17 Ad–22(e)(2). 19 17 CFR 240.19b–4(f). to File Number SR–ICEEU–2021–007

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and should be submitted on or before Exchange has prepared summaries, set discrimination between customers, April 6, 2021. forth in sections A, B, and C below, of issuers, brokers, or dealers. For the Commission, by the Division of the most significant aspects of such The Exchange’s proposed changes to Trading and Markets, pursuant to delegated statements. its Pricing Schedule are reasonable in 20 authority. A. Self-Regulatory Organization’s several respects. As a threshold matter, J. Mathew DeLesDernier, Statement of the Purpose of, and the Exchange is subject to significant Assistant Secretary. Statutory Basis for, the Proposed Rule competitive forces in the market for [FR Doc. 2021–05339 Filed 3–15–21; 8:45 am] Change options securities transaction services BILLING CODE 8011–01–P that constrain its pricing determinations 1. Purpose in that market. The fact that this market is competitive has long been recognized The purpose of the proposed rule SECURITIES AND EXCHANGE by the courts. In NetCoalition v. change is to amend the Exchange’s COMMISSION Securities and Exchange Commission, Pricing Schedule at Options 7, Section the D.C. Circuit stated as follows: ‘‘[n]o [Release No. 34–91295; File No. SR–ISE– 3 (Regular Order Fees and Rebates) to: one disputes that competition for order 2021–03] 3 (i) Decrease the Priority Customer taker flow is ‘fierce.’ . . . As the SEC 4 fee in Select Symbols, and (ii) increase explained, ‘[i]n the U.S. national market Self-Regulatory Organizations; Nasdaq 5 the Non-Priority Customer maker fee system, buyers and sellers of securities, ISE, LLC; Notice of Filing and in Select Symbols. Immediate Effectiveness of Proposed and the broker-dealers that act as their Rule Change To Amend the The Exchange initially filed the order-routing agents, have a wide range Exchange’s Pricing Schedule at proposed pricing changes on March 1, of choices of where to route orders for Options 7, Section 3 2021 (SR–ISE–2021–02). On March 2, execution’; [and] ‘no exchange can 2021, the Exchange withdrew that filing afford to take its market share March 10, 2021. and submitted this filing. percentages for granted’ because ‘no Pursuant to Section 19(b)(1) of the Today, Priority Customers are charged exchange possesses a monopoly, Securities Exchange Act of 1934 a taker fee of $0.41 per contract for regulatory or otherwise, in the execution 1 2 (‘‘Act’’), and Rule 19b–4 thereunder, regular orders in Select Symbols. The of order flow from broker notice is hereby given that on March 2, Exchange now proposes to decrease this dealers’....’’9 2021, Nasdaq ISE, LLC (‘‘ISE’’ or fee to $0.37 per contract for Priority The Commission and the courts have ‘‘Exchange’’) filed with the Securities Customers. repeatedly expressed their preference and Exchange Commission for competition over regulatory Today, all Non-Priority Customers are (‘‘Commission’’) the proposed rule intervention in determining prices, charged a maker fee of $0.11 per change as described in Items I and II, products, and services in the securities contract for regular orders in Select below, which Items have been prepared markets. In Regulation NMS, while Symbols. The Exchange now proposes by the Exchange. The Commission is adopting a series of steps to improve the to increase this fee to $0.18 per contract publishing this notice to solicit current market model, the Commission for all Non-Priority Customers.6 comments on the proposed rule change highlighted the importance of market from interested persons. 2. Statutory Basis forces in determining prices and SRO revenues and, also, recognized that I. Self-Regulatory Organization’s The Exchange believes that its Statement of the Terms of Substance of current regulation of the market system proposal is consistent with Section 6(b) ‘‘has been remarkably successful in the Proposed Rule Change 7 of the Act, in general, and furthers the promoting market competition in its The Exchange proposes to amend the objectives of Sections 6(b)(4) and 6(b)(5) broader forms that are most important to 8 Exchange’s Pricing Schedule at Options of the Act, in particular, in that it investors and listed companies.’’ 10 7, Section 3 (Regular Order Fees and provides for the equitable allocation of Numerous indicia demonstrate the Rebates), as described further below. reasonable dues, fees, and other charges competitive nature of this market. For The text of the proposed rule change among members and issuers and other is available on the Exchange’s website at example, clear substitutes to the persons using any facility, and is not Exchange exist in the market for options https://listingcenter.nasdaq.com/ designed to permit unfair rulebook/ise/rules, at the principal security transaction services. The Exchange is only one of sixteen options office of the Exchange, and at the 3 A ‘‘Priority Customer’’ is a person or entity that exchanges to which market participants Commission’s Public Reference Room. is not a broker/dealer in securities, and does not place more than 390 orders in listed options per day may direct their order flow. Within this II. Self-Regulatory Organization’s on average during a calendar month for its own environment, market participants can Statement of the Purpose of, and beneficial account(s), as defined in Nasdaq ISE freely and often do shift their order flow Statutory Basis for, the Proposed Rule Options 1, Section 1(a)(37). among the Exchange and competing Change 4 ‘‘Select Symbols’’ are options overlying all symbols listed on the Nasdaq ISE that are in the venues in response to changes in their In its filing with the Commission, the Penny Interval Program. respective pricing schedules. As such, Exchange included statements 5 ‘‘Non-Priority Customers’’ include Market the proposal represents a reasonable concerning the purpose of and basis for Makers, Non-Nasdaq ISE Market Makers, Firm attempt by the Exchange to increase its Proprietary/Broker Dealers, and Professional liquidity and market share relative to its the proposed rule change and discussed Customers. any comments it received on the 6 The Exchange notes that under this proposal, competitors. proposed rule change. The text of these Market Makers that qualify for Market Maker Plus statements may be examined at the in Select Symbols will continue to receive the 9 NetCoalition v. SEC, 615 F.3d 525, 539 (D.C. Cir. places specified in Item IV below. The applicable Market Maker Plus rebates in Select 2010) (quoting Securities Exchange Act Release No. Symbols set forth in note 5 of Options 7, Section 59039 (December 2, 2008), 73 FR 74770, 74782–83 3, and will not pay the proposed $0.18 per contract (December 9, 2008) (SR–NYSEArca–2006–21)). 20 17 CFR 200.30–3(a)(12). maker fee. 10 See Securities Exchange Act Release No. 51808 1 15 U.S.C. 78s(b)(1). 7 15 U.S.C. 78f(b). (June 9, 2005), 70 FR 37496, 37499 (June 29, 2005) 2 17 CFR 240.19b–4. 8 15 U.S.C. 78f(b)(4) and (5). (‘‘Regulation NMS Adopting Release’’).

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The Exchange believes that the lower rate to Priority Customers C. Self-Regulatory Organization’s proposed decrease for the Priority compared to other market participants. Statement on Comments on the Customer taker fee in Select Symbols is Proposed Rule Change Received From reasonable, equitable, and not unfairly B. Self-Regulatory Organization’s Members, Participants, or Others Statement on Burden on Competition discriminatory. As discussed above, this No written comments were either fee will decrease from $0.41 to $0.37 per The Exchange does not believe that solicited or received. contract for Priority Customers. The the proposed rule change will impose Exchange seeks to incentivize Priority III. Date of Effectiveness of the any burden on competition not Customer participation, in particular, Proposed Rule Change and Timing for Priority Customer activity to remove necessary or appropriate in furtherance Commission Action of the purposes of the Act. In terms of liquidity in Select Symbols, with the The foregoing rule change has become intra-market competition, the Exchange proposed change. As amended, Priority effective pursuant to Section Customers will continue to be charged does not believe that its proposal will 19(b)(3)(A)(ii) of the Act 13 and Rule the lowest taker fee in Select Symbols.11 place any category of market participant 19b–4(f)(2) 14 thereunder. At any time The Exchange believes that it is at a competitive disadvantage. The within 60 days of the filing of the equitable and not unfairly proposed Select Symbol taker fee will proposed rule change, the Commission discriminatory to charge Priority be decreased for Priority Customers, summarily may temporarily suspend Customers a lower taker fee than other who will continue to be charged at a such rule change if it appears to the market participants as the Exchange has lower rate than all other market Commission that such action is: (i) historically offered lower execution fees participants for removing liquidity on Necessary or appropriate in the public to Priority Customers. Furthermore, the Exchange. The proposed Select interest; (ii) for the protection of Priority Customer order flow enhances Symbol maker fee will be increased investors; or (iii) otherwise in liquidity on the Exchange for the benefit uniformly for all Non-Priority furtherance of the purposes of the Act. of all market participants by providing Customers, while Priority Customers If the Commission takes such action, the more trading opportunities, which in will continue to be assessed no fee for Commission shall institute proceedings turn attracts Market Makers and other adding liquidity on the Exchange. As to determine whether the proposed rule market participants who may interact discussed above, the Exchange has should be approved or disapproved. with this order flow. The Exchange believes that the historically charged lower rates to IV. Solicitation of Comments proposed increase for the Non-Priority Priority Customers compared to other Interested persons are invited to Customer maker fees in Select Symbols market participants. The Exchange submit written data, views, and is reasonable, equitable, and not believes that this incentivizes increased arguments concerning the foregoing, unfairly discriminatory. As discussed Priority Customer order flow, which including whether the proposed rule above, this fee will increase from $0.11 enhances liquidity on the Exchange for change is consistent with the Act. to $0.18 per contract for all Non-Priority the benefit of all market participants by Comments may be submitted by any of Customers. While the maker fee is providing more trading opportunities, the following methods: increasing for Non-Priority Customers, which in turn attracts Market Makers the proposed increase is intended to and other market participants who may Electronic Comments offset the cost of decreasing the Priority interact with this order flow. • Use the Commission’s internet Customer taker fee proposed above. In terms of inter-market competition, comment form (http://www.sec.gov/ rules/sro.shtml); or Furthermore, the Exchange notes that the Exchange notes that it operates in a the proposed maker fees remain lower • Send an email to rule-comments@ highly competitive market in which sec.gov. Please include File Number SR– than maker fees at another options market participants can readily favor exchange.12 ISE–2021–03 on the subject line. competing venues if they deem fee The Exchange believes that the Paper Comments proposed maker fees in Select Symbols levels at a particular venue to be • is equitable and not fairly excessive, or rebate opportunities Send paper comments in triplicate discriminatory because they will be available at other venues to be more to Secretary, Securities and Exchange increased uniformly for all Non-Priority favorable. In such an environment, the Commission, 100 F Street NE, Customers. Priority Customers will Exchange must continually adjust its Washington, DC 20549–1090. continue to be assessed no maker fees in fees to remain competitive with other All submissions should refer to File Select Symbols under this proposal. For options exchanges. Because competitors Number SR–ISE–2021–03. This file the same reasons discussed above for are free to modify their own fees in number should be included on the the proposed Priority Customer taker response, and because market subject line if email is used. To help the fees, the Exchange believes that it is participants may readily adjust their Commission process and review your equitable and not unfairly order routing practices, the Exchange comments more efficiently, please use discriminatory to continue offering a believes that the degree to which fee only one method. The Commission will changes in this market may impose any post all comments on the Commission’s 11 Today, the Exchange charges all Non-Priority burden on competition is extremely internet website (http://www.sec.gov/ Customers (except Market Makers) a taker fee of rules/sro.shtml). Copies of the $0.46 per contract in Select Symbols. Marker limited. For example, while the Exchange is increasing the maker fees submission, all subsequent Makers are currently charged a taker fee of $0.45 amendments, all written statements per contract in Select Symbols. for Non-Priority Customers in Select 12 with respect to the proposed rule See, e.g., Nasdaq PHLX (‘‘Phlx’’) Pricing Symbols under this proposal, the Schedule at Options 7, Section 4, which assesses change that are filed with the Exchange does not believe this will Lead Market Makers and Market Makers an Commission, and all written electronic options transaction charge of $0.22 per cause an undue burden on inter-market communications relating to the contract in Penny Symbols, and Professionals, competition as the proposed fees remain Broker-Dealers, and Firms an electronic options transaction charge of $0.48 per contract in Penny lower than similar fees charged by other 13 15 U.S.C. 78s(b)(3)(A)(ii). Symbols. options exchanges such as Phlx. 14 17 CFR 240.19b–4(f)(2).

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proposed rule change between the CFR 230.601 to 610a) to report semi- SECURITIES AND EXCHANGE Commission and any person, other than annually on Form 2–E (17 CFR 239.201) COMMISSION those that may be withheld from the the progress of the offering. The form [Release No. 34–91286; File Nos. SR– public in accordance with the solicits information such as the dates an NASDAQ–2020–081; SR–NASDAQ–2020– provisions of 5 U.S.C. 552, will be offering commenced and was completed 082] available for website viewing and (if completed), the number of shares printing in the Commission’s Public sold and still being offered, amounts Self-Regulatory Organizations; The Reference Room, 100 F Street NE, received in the offering, and expenses Nasdaq Stock Market LLC; Notice of Washington, DC 20549, on official and underwriting discounts incurred in Filing of Amendments No. 1 and Order business days between the hours of the offering. The information provided Instituting Proceedings To Determine 10:00 a.m. and 3:00 p.m. Copies of the on Form 2–E assists the staff in Whether To Approve or Disapprove Proposed Rule Changes, as Modified filing also will be available for monitoring the progress of the offering inspection and copying at the principal by Amendments No. 1, To Adopt and in determining whether the offering office of the Exchange. All comments Listing Rules Related to Board has stayed within the limits set for an received will be posted without change. Diversity and To Offer Certain Listed Persons submitting comments are offering exempt under Regulation E. Companies Access to a cautioned that we do not redact or edit The Commission estimates that, on Complimentary Board Recruiting personal identifying information from average, approximately one respondent Solution To Help Advance Diversity on comment submissions. You should submits a Form 2–E filing each year. Company Boards submit only information that you wish The Commission further estimates that to make available publicly. All this information collection imposes an March 10, 2021. submissions should refer to File annual burden of four hours and I. Introduction Number SR–ISE–2021–03 and should be imposes an annual external cost burden On December 1, 2020, The Nasdaq submitted on or before April 6, 2021. of zero. Stock Market LLC (‘‘Nasdaq’’ or For the Commission, by the Division of The collection of information under ‘‘Exchange’’) filed with the Securities Trading and Markets, pursuant to delegated Form 2–E is mandatory. The and Exchange Commission authority.15 information provided by the form will (‘‘Commission’’), pursuant to Section J. Matthew DeLesDernier, not be kept confidential. An agency may 19(b)(1) of the Securities Exchange Act Assistant Secretary. not conduct or sponsor, and a person is of 1934 (‘‘Act’’) 1 and Rule 19b–4 [FR Doc. 2021–05342 Filed 3–15–21; 8:45 am] not required to respond to, a collection thereunder,2 a proposed rule change to BILLING CODE 8011–01–P of information unless it displays a adopt listing rules related to board currently valid OMB control number. diversity (‘‘Board Diversity Proposal’’). The proposed rule change was SECURITIES AND EXCHANGE The public may view the background published for comment in the Federal COMMISSION documentation for this information Register on December 11, 2020.3 On collection at the following website, [SEC File No. 270–222, OMB Control No. January 19, 2021, pursuant to Section 3235–0233] www.reginfo.gov. Comments should be 19(b)(2) of the Act,4 the Commission directed to: (i) Desk Officer for the designated a longer period within which Submission for OMB Review; Securities and Exchange Commission, to approve the proposed rule change, Comment Request Office of Information and Regulatory disapprove the proposed rule change, or Affairs, Office of Management and institute proceedings to determine Upon Written Request, Copies Available Budget, Room 10102, New Executive whether to disapprove the proposed From: Securities and Exchange Office Building, Washington, DC 20503, rule change.5 On February 26, 2021, the Commission, Office of FOIA Services, Exchange filed Amendment No. 1 to the 100 F Street NE, Washington, DC or by sending an email to: proposed rule change, which replaced 20549–2736 [email protected]; and (ii) David Bottom, Director/Chief and superseded the proposed rule Extension: Information Officer, Securities and change as originally filed.6 Form 2–E, Report pursuant to rule 609 of Exchange Commission, c/o Cynthia Regulation E 1 Roscoe, 100 F Street NE, Washington, 15 U.S.C. 78s(b)(1). Notice is hereby given that, pursuant _ 2 17 CFR 240.19b–4. DC 20549 or send an email to: PRA 3 See Securities Exchange Act Release No. 90574 to the Paperwork Reduction Act of 1995 [email protected]. Written comments (44 U.S.C. 3501 et seq.), the Securities (December 4, 2020), 85 FR 80472 (SR–NASDAQ– and recommendations for the proposed 2020–081). Comments received on the Board and Exchange Commission (the information collection should be sent Diversity Proposal are available on the ‘‘Commission’’) has submitted to the Commission’s website at: https://www.sec.gov/ Office of Management and Budget within 30 days of publication of this comments/sr-nasdaq-2020-081/ (‘‘OMB’’) a request for extension of the notice to www.reginfo.gov/public/do/ srnasdaq2020081.htm. 4 15 U.S.C. 78s(b)(2). previously approved collection of PRAMain. Find this particular information collection by selecting 5 See Securities Exchange Act Release No. 90951, information discussed below. 86 FR 7135 (January 26, 2021). The Commission Rule 609 (17 CFR 230.609) under the ‘‘Currently under 30-day Review—Open designated March 11, 2021 as the date by which the Securities Act of 1933 (15 U.S.C. 77a et for Public Comments’’ or by using the Commission shall approve or disapprove, or seq.) requires small business investment search function. institute proceedings to determine whether to disapprove, the proposed rule change. companies and business development Dated: March 11, 2021. 6 In Amendment No. 1, the Exchange amended companies that have engaged in J. Matthew DeLesDernier, the Board Diversity Proposal to: (1) Add a defined offerings of securities that are exempt term for ‘‘Two or More Races or Ethnicities’’ to from registration pursuant to Regulation Assistant Secretary. proposed Rule 5605(f)(1); (2) modify the application [FR Doc. 2021–05377 Filed 3–15–21; 8:45 am] of proposed Rule 5605(f) to Foreign Issuers and E under the Securities Act of 1933 (17 clarify the scope of Exempt Companies; (3) provide BILLING CODE 8011–01–P a lower diversity objective for a company with five 15 17 CFR 200.30–3(a)(12). or fewer members on its board; (4) modify the

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On December 1, 2020, the Exchange The Commission is publishing this Hispanic or Latinx, Asian, Native also filed with the Commission, notice and order to solicit comments on American or Alaska Native, Native pursuant to Section 19(b)(1) of the Act 7 the proposed rule changes, as modified Hawaiian or Pacific Islander, or Two or and Rule 19b–4 thereunder,8 a proposed by Amendments No. 1, from interested More Races or Ethnicities; 16 and rule change to offer certain listed persons and to institute proceedings ‘‘LGBTQ+’’ would be defined to mean companies access to a complimentary pursuant to Section 19(b)(2)(B) of the an individual who self-identifies as any board recruiting solution to help Act 13 to determine whether to approve of the following: , gay, bisexual, advance diversity on company boards or disapprove the proposed rule transgender, or as a member of the queer (‘‘Board Recruiting Service Proposal’’). changes, as modified by Amendments community.17 The proposed rule change was No.1. The Exchange proposes to define a published for comment in the Federal Foreign Issuer under proposed Rule II. Description of the Proposed Rule Register on December 10, 2020.9 On 5605(f)(1) as: (a) A Foreign Private Changes, as Modified by Amendments January 19, 2021, pursuant to Section Issuer (as defined in Rule No. 1 19(b)(2) of the Act,10 the Commission 5005(a)(19)); 18 or (b) a company that (i) designated a longer period within which A. The Board Diversity Proposal is considered a ‘‘foreign issuer’’ under to approve the proposed rule change, Rule 3b–4(b) under the Act 19 and (ii) 1. Proposed Rule 5605(f) disapprove the proposed rule change, or institute proceedings to determine The Exchange proposes to adopt new 16 ‘‘Black or African American’’ would be defined whether to disapprove the proposed Rule 5605(f)(2), which would require to mean a person having origins in any of the Black racial groups of Africa (not of Hispanic or Latinx 11 each Nasdaq-listed company (other than rule change. On February 26, 2021, the origin). See Amendment No. 1 to the Board Exchange filed Amendment No. 1 to the a Foreign Issuer, Smaller Reporting Diversity Proposal at 327. ‘‘Hispanic or Latinx’’ proposed rule change, which replaced Company, or Company with a Smaller would be defined to mean a person of Cuban, and superseded the proposed rule Board, as discussed below) to have, or Mexican, Puerto Rican, South or Central American, or other Spanish culture or origin, regardless of 12 explain why it does not have, at least change as originally filed. race. See id. ‘‘Asian’’ would be defined to mean a two members of its board of directors person having origins in any of the original peoples disclosures required by proposed Rule 5606; (5) who are Diverse,14 including at least one of the Far East, Southeast Asia, or the Indian modify the process by which a company may Diverse director who self-identifies as subcontinent, including, for example, Cambodia, provide public disclosure if it does not meet the Female and at least one Diverse director China, India, Japan, Korea, Malaysia, Pakistan, the applicable board diversity objectives of proposed Philippine Islands, Thailand, and Vietnam. See id. Rule 5605(f)(2) and similarly conform the process who self-identifies as an ‘‘Native American or Alaska Native’’ would be for providing the public disclosures under proposed Underrepresented Minority or defined to mean a person having origins in any of Rule 5606; (6) modify the phase-in periods for LGBTQ+.15 Pursuant to proposed Rule the original peoples of North and South America companies subject to proposed Rules 5605(f) and 5605(f)(1), ‘‘Diverse’’ would be defined (including Central America) and who maintains 5606; (7) provide a grace period for a company that cultural identification through tribal affiliation or no longer meets the board diversity objectives of to mean an individual who self- community recognition. See id. ‘‘Native Hawaiian proposed Rule 5605(f)(2) due to a vacancy on its identifies in one or more of the or Pacific Islander’’ would be defined to mean a board and clarify the cure period for a company that following categories: (i) Female, (ii) person having origins in any of the peoples of does not satisfy proposed Rule 5605(f); (8) modify Underrepresented Minority, or (iii) , Guam, Samoa, or other Pacific Islands. See the effective dates and transition periods applicable id. ‘‘Two or More Races or Ethnicities’’ would be to proposed Rules 5605(f) and 5606; (9) make LGBTQ+. Also pursuant to proposed defined to mean a person who identifies with more conforming and clarifying changes throughout the Rule 5605(f)(1), ‘‘Female’’ would be than one of the following categories: White (not of description of the proposed rule change and the defined to mean an individual who self- Hispanic or Latinx origin), Black or African proposed rule text; and (10) provide additional identifies her gender as a woman, American, Hispanic or Latinx, Asian, Native justification and support for the proposed rule American or Alaska Native, Native Hawaiian or change. The full text of Amendment No. 1 to the without regard to the individual’s Pacific Islander. See id.; proposed Rule 5605(f)(1). Board Diversity Proposal is available on the designated sex at birth; ‘‘White (not of Hispanic or Latinx origin)’’ would Commission’s website at: https://www.sec.gov/ ‘‘Underrepresented Minority’’ would be be defined to mean a person having origins in any comments/sr-nasdaq-2020-081/srnasdaq2020081- defined to mean an individual who self- of the original peoples of Europe, the Middle East, 8425992-229601.pdf. or North Africa. See Amendment No. 1 to the Board 7 15 U.S.C. 78s(b)(1). identifies as one or more of the Diversity Proposal at 327. 8 17 CFR 240.19b–4. following: Black or African American, 17 See proposed Rule 5605(f)(1). The Exchange 9 See Securities Exchange Act Release No. 90571 states that the categories it has proposed to (December 4, 2020), 85 FR 79556 (SR–NASDAQ– comments/sr-nasdaq-2020-082/srnasdaq2020082- comprise an Underrepresented Minority are 2020–082). Comments received on the Board 8425987-229599.pdf. consistent with the categories reported to the Equal Recruiting Service Proposal are available on the 13 15 U.S.C. 78s(b)(2)(B). Employment Opportunity Commission (‘‘EEOC’’) Commission’s website at: https://www.sec.gov/ 14 The Exchange states that it has published an through the Employer Information Report EEO–1 comments/sr-nasdaq-2020-082/ FAQ on its Listing Center clarifying that ‘‘two Form (‘‘EEO–1’’) and should be construed in srnasdaq2020082.htm. members of its board of directors who are Diverse’’ accordance with the EEOC’s definitions. See 10 15 U.S.C. 78s(b)(2). would exclude emeritus directors, retired directors, Amendment No. 1 to the Board Diversity Proposal 11 See Securities Exchange Act Release No. 90952, and members of an advisory board. See Amendment at 9–10, 61. The Exchange also states that, while the 86 FR 7148 (January 26, 2021). The Commission No. 1 to the Board Diversity Proposal at 73 n.187. EEO–1 report refers to ‘‘Hispanic or Latino’’ rather designated March 10, 2021 as the date by which the 15 See proposed Rule 5605(f)(2)(A). The Exchange than ‘‘Latinx,’’ the Exchange proposes to use the Commission shall approve or disapprove, or also states that it does not intend for the Board term ‘‘Latinx’’ to apply broadly to all gendered and institute proceedings to determine whether to Diversity Proposal to preclude companies from gender-neutral forms that may be used by disapprove, the proposed rule change. considering additional diverse attributes, such as individuals of Latin American heritage, including 12 In Amendment No. 1, the Exchange amended nationality, disability, or veteran status, in selecting individuals who self-identify as Latino/a/e. See id. the Board Recruiting Service Proposal to: (1) Make board members; however, the company would still at 61 n.160. The Exchange further states that the conforming changes to the proposal based on have to provide the required disclosure under terms in the proposed definition of LGBTQ+ are Amendment No. 1 to the Board Diversity Proposal; proposed Rule 5605(f)(3) if the company does not similar to the identities defined in California’s A.B. (2) specify the application of the proposal to a meet the diversity objectives of proposed Rule 979, but have been expanded to include the queer company with five or fewer members on its board; 5605(f)(2). See Amendment No. 1 to the Board community. See id. at 61. (3) provide additional justification for the proposal Diversity Proposal at 64. The Exchange also states 18 Under Rule 5005(a)(19), the term Foreign to allow eligible companies until December 1, 2022 that, although non-binary is included as a category Private Issuer has ‘‘the same meaning as under Rule to begin using the complimentary board recruiting in the Board Diversity Matrix under proposed Rule 3b–4 under the Act.’’ solution; and (4) make additional clarifying changes 5606 (as discussed in Section II.A.2 below), a 19 See 17 CFR 240.3b–4(b) (‘‘The term foreign throughout the description of the proposed rule company would not satisfy the diversity objectives issuer means any issuer which is a foreign change. The full text of Amendment No. 1 to the in proposed Rule 5605(f)(2) to have a minimum government, a national of any foreign country or a Board Recruiting Service Proposal is available on number of Diverse directors if a director self- corporation or other organization incorporated or the Commission’s website at: https://www.sec.gov/ identifies solely as non-binary. See id. at 66 n.173. organized under the laws of any foreign country.’’).

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has its principal executive offices The Exchange proposes to define a one director to its board in order to located outside of the United States.20 Smaller Reporting Company as set forth satisfy proposed Rule 5605(f)(2)(D), For Foreign Issuers, the Exchange in Rule 12b–2 under the Act.24 Proposed thereby becoming a six-member board.27 proposes to define ‘‘Diverse’’ to mean an Rule 5605(f)(2)(C) would require each However, a Company with a Smaller individual who self-identifies as one or Smaller Reporting Company (other than Board would become subject to more of the following: Female, LGBTQ+, a Company with a Smaller Board, as proposed Rule 5605(f)(2)(A), (B), or (C) or an underrepresented individual discussed below) to have, or explain if it subsequently expands its board.28 based on national, racial, ethnic, why it does not have, at least two If a company elects to satisfy the indigenous, cultural, religious, or members of its board of directors who requirements of proposed Rule linguistic identity in the country of the are Diverse, including at least one 5605(f)(2) by disclosing why it does not company’s principal executive offices as Diverse director who self-identifies as meet the applicable diversity objectives reported on the company’s Form F–1, Female. As proposed, the second of proposed Rule 5605(f)(2), proposed 10–K, 20–F, or 40–F Diverse director may include an Rule 5605(f)(3) would require the (‘‘Underrepresented Individual’’).21 For individual who self-identifies as one or company to: (i) Specify the a Foreign Issuer that has a two-tiered more of the following: Female, LGBTQ+, requirements of proposed Rule board system, the Exchange proposes to or an Underrepresented Minority.25 5605(f)(2) that are applicable (e.g., the define ‘‘board of directors’’ to mean the Proposed Rule 5605(f)(2)(D) would applicable subparagraph and the company’s supervisory or non- require each company with a board of applicable diversity objectives); and (ii) management board.22 Proposed Rule directors of five or fewer members explain the reasons why it does not 5605(f)(2)(B) would require each (‘‘Company with a Smaller Board’’) to have two Diverse directors (or one Foreign Issuer (other than a Company have, or explain why it does not have, Diverse director for a Company with a with a Smaller Board, as discussed at least one member of its board of Smaller Board).29 The disclosure must below) to have, or explain why it does directors who is Diverse.26 As proposed, be provided in advance of the not have, at least two members of its if a company had five members on its company’s next annual meeting of board of directors who are Diverse, board of directors before becoming shareholders: (a) In any proxy statement including at least one Diverse director subject to proposed Rule 5605(f), it or any information statement (or, if a who self-identifies as Female. As would not become subject to the company does not file a proxy, in its proposed, the second Diverse director objectives of proposed Rule Form 10–K or 20–F); or (b) on the may include an individual who self- 5605(f)(2)(A), (B), or (C) to have at least company’s website.30 If the company identifies as one or more of the two Diverse directors if it then added provides the disclosure on its website, following: Female, LGBTQ+, or an the company must submit such Underrepresented Individual.23 discussed in Section II.A.2 below) to the list of disclosure concurrently with the filing excluded corporate governance rules. However, the made pursuant to (a) above and submit Exchange states that Foreign Private Issuers that 20 According to the Exchange, this definition is elect to follow an alternative diversity objective in a URL link to the disclosure through the designed to recognize that companies that are not accordance with home country practices, or are Nasdaq Listing Center, within one Foreign Private Issuers but are headquartered located in jurisdictions that restrict the collection business day after such posting.31 outside of the United States are foreign companies of personal data, may satisfy the requirements of Proposed Rule 5605(f)(5) would notwithstanding the fact that they file domestic proposed Rule 5605(f) by explaining their reasons Commission reports, and is designed to exclude for doing so instead of meeting the diversity specify the phase-in period for any companies that are domiciled in a foreign objectives of the rule. See Amendment No. 1 to the jurisdiction without having a physical presence in Board Diversity Proposal at 84. 27 See proposed Rule 5605(f)(2)(D). The Exchange that country. See Amendment No. 1 to the Board 24 See proposed Rule 5605(f)(1). See also 17 CFR proposes this exception to avoid complexity for Diversity Proposal at 83. 240.12b–2 (defining a Smaller Reporting Company Companies with a Smaller Board that attempt to 21 See proposed Rule 5605(f)(2)(B)(i). The as ‘‘an issuer that is not an investment company, satisfy the diversity objectives by adding a Diverse Exchange states that its proposed definition of an an asset-backed issuer . . ., or a majority-owned director to their board, and to prevent such Underrepresented Individual is based on the United subsidiary of a parent that is not a smaller reporting companies from thereby being subject to a higher Nations Declaration on the Rights of Persons company and that: (1) Had a public float of less threshold (i.e., that of proposed Rule 5605(f)(2)(A), Belonging to National or Ethnic, Religious and than $250 million; or (2) Had annual revenues of (B), or (C)) as a result. See Amendment No. 1 to the Linguistic Minorities and the United Nations less than $100 million and either: (i) No public Board Diversity Proposal at 86–87. Declaration on the Rights of Indigenous Peoples. float; or (ii) A public float of less than $700 28 See proposed Rule 5605(f)(2)(D). See Amendment No. 1 to the Board Diversity million’’). 29 As proposed, a company would not need to Proposal at 69 (citing G.A. Res. 47/135, art. 1.1 25 The Exchange states that, because smaller provide any public disclosures pursuant to (December 18, 1992); G.A. Res. 61/295 (September companies may not have the resources necessary to proposed Rule 5605(f) if the company demonstrates 13, 2007)). The Exchange also states that, because compensate an additional director or engage a under proposed Rule 5606 (as discussed in Section the EEOC categories of race and ethnicity may not search firm to search outside of directors’ networks, II.A.2 below) that it meets the applicable diversity extend to all countries globally since each country it proposes to provide each Smaller Reporting objectives of proposed Rule 5605(f)(2); however, if has its own unique demographic composition, and Company with additional flexibility (i.e., proposed a company does not meet its applicable diversity because on average women tend to be Rule 5605(f)(2)(C) would allow these companies to objectives, it would be required to provide the underrepresented in boardrooms across the globe, satisfy the objective to have two Diverse directors additional public disclosure explaining why it does proposed Rule 5605(f)(2)(B)(ii) would allow Foreign by having two Female directors). See Amendment not meet the applicable objectives. See Amendment Issuers to satisfy the diversity objectives by having No. 1 to the Board Diversity Proposal at 84–85. No. 1 to the Board Diversity Proposal at 73. two Female directors. See id. at 81–82. 26 The Exchange proposes this alternative 30 See proposed Rule 5605(f)(3). 22 See proposed Rule 5605(f)(2)(B)(i). The diversity objective for Companies with a Smaller 31 See id. The Exchange states that it would not Exchange states that this is consistent with Rule Board because, according to the Exchange, these evaluate the substance or merits of a company’s 10A–3(e)(2) under the Act. See Amendment No. 1 companies may face similar resource constraints to explanation provided pursuant to proposed Rule to the Board Diversity Proposal at 84 (citing 17 CFR those of Smaller Reporting Companies, but not all 5605(f)(3), but would verify that the company has 240.10A–3(e)(2)). Companies with a Smaller Board are Smaller provided one at the time it files its proxy statement 23 The Exchange also proposes to amend Rule Reporting Companies, and therefore the alternative or information statement (or, if the company does 5615 and IM–5615–3, which currently permit a diversity objective that would be provided to not file a proxy, at the time it files its Form 10– Foreign Private Issuer to follow home country Smaller Reporting Companies may not be available K or 20–F). See Amendment No. 1 to the Board practices in lieu of the requirements set forth in the to them. See id. at 86. The Exchange further states Diversity Proposal at 74. If the company does not Rule 5600 series, subject to several exclusions. that Companies with a Smaller Board may be meet the applicable diversity objectives and has not Specifically, the Exchange proposes to amend Rule disproportionately impacted by the proposed rule provided any explanation, or has provided an 5615 and IM–5615–3 to add proposed Rule 5605(f) change if they plan to satisfy proposed Rule explanation that does not satisfy proposed Rule to the list of excluded corporate governance rules. 5605(f)(2) by adding additional directors, which 5605(f)(3)(i) and (ii), the company will be The Exchange also proposes to amend Rule 5615 may impose additional costs in the form of director considered deficient with the requirements of and IM–5615–3 to add proposed Rule 5606 (as compensation and D&O insurance. See id. proposed Rule 5605(f)(3). See id. at 74–75.

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company newly listing on the Exchange second annual meeting of shareholders the date of vacancy, to satisfy proposed that was not previously subject to a subsequent to the company’s listing.35 Rule 5605(f)(2) or (3). As proposed, in substantially similar requirement of Proposed Rule 5605(f)(5)(C) would lieu of providing the disclosure required another national securities exchange provide that any company that ceases to by proposed Rule 5605(f)(3), a company (including through an initial public be a Foreign Issuer, Smaller Reporting relying on this rule may publicly offering, direct listing, transfer from Company, or Exempt Company would disclose that it is relying on the grace another exchange or the over-the- be permitted to satisfy the requirements period provided by proposed Rule counter market, in connection with a of proposed Rule 5605(f) by the later of: 5605(f)(6)(B).38 This disclosure must be spin-off or carve-out from a company (i) One year from the date that the provided in advance of the company’s listed on the Exchange or another company no longer qualifies as a next annual meeting of shareholders: (a) exchange, or through a merger with an Foreign Issuer, Smaller Reporting In any proxy statement or any acquisition company listed under IM– Company, or Exempt Company; or (ii) information statement (or, if the 5101–2 (‘‘acquisition company’’)) and the date the company files its proxy company does not file a proxy, in its any company that ceases to be a Foreign statement or information statement (or, Form 10–K or 20–F); or (b) on the Issuer, a Smaller Reporting Company, or if the company does not file a proxy, its company’s website.39 If the company an Exempt Company.32 Form 10–K or 20–F) for the company’s provides such disclosure on its website, As proposed, any newly-listed first annual meeting of shareholders then the company must submit such company on the Nasdaq Global Select subsequent to such event. disclosure concurrently with the filing Market (‘‘NGS’’) or Nasdaq Global Proposed Rule 5605(f)(6)(A) would made pursuant to (a) and submit a URL Market (‘‘NGM’’) would be permitted to provide that if a company (i) does not link to the disclosure through the satisfy the requirement of proposed Rule meet the applicable diversity objectives Nasdaq Listing Center, within one 5605(f)(2) to have, or explain why it under proposed Rule 5605(f)(2) and fails business day after such posting.40 does not have: (i) At least one Diverse to provide the disclosure required by Proposed Rule 5605(f)(7) would director by the later of (a) one year from proposed Rule 5605(f)(3), or (ii) fails to specify the transition period for the the date of listing or (b) the date the hold an annual meeting of shareholders implementation of the requirements of company files its proxy statement or during the applicable periods in proposed Rule 5605(f). As proposed, information statement (or, if the proposed Rule 5605(f)(5) or (7) and each company listed on the Exchange company does not file a proxy, its Form therefore fails to meet, or explain why (including a Company with a Smaller 10–K or 20–F) for the company’s first it does not meet, the diversity objectives Board) would be required to have, or annual meeting of shareholders of proposed Rule 5605(f)(2), the explain why it does not have, at least subsequent to the company’s listing; Exchange’s Listing Qualifications one Diverse director by the later of: (i) and (ii) at least two Diverse directors by Department would promptly notify the Two calendar years after the approval the later of (a) two years from the date company and inform it that it has until date of the proposal (‘‘First Effective of listing or (b) the date the company the later of its next annual shareholders Date’’); or (ii) the date the company files files its proxy statement or information meeting or 180 days from the event that its proxy statement or information statement (or, if the company does not caused the deficiency to cure the statement (or, if the company does not file a proxy, its Form 10–K or 20–F) for deficiency.36 If a company does not file a proxy, its Form 10–K or 20–F) for the company’s second annual meeting regain compliance within the applicable the company’s annual shareholders of shareholders subsequent to the cure period, the Listings Qualifications meeting during the calendar year of the company’s listing.33 In addition, any Department would issue a Staff First Effective Date.41 In addition, each newly-listed company on the Nasdaq Delisting Determination Letter.37 company listed on NGS or NGM must Capital Market (‘‘NCM’’) would be Moreover, proposed Rule 5605(f)(6)(B) have, or explain why it does not have, permitted to satisfy the requirement of would provide that a company that has at least two Diverse directors by the proposed Rule 5605(f)(2) to have, or satisfied the diversity objectives of later of: (i) Four calendar years after the explain why it does not have, at least proposed Rule 5605(f)(2) within the approval date of the proposal (‘‘Second two Diverse directors by the later of: (i) timeframes set forth in proposed Rule NGS/NGM Effective Date’’); or (ii) the Two years from the date of listing; or (ii) 5605(f)(7), but later ceases to meet the date the company files its proxy the date the company files its proxy diversity objectives of proposed Rule statement or information statement (or, statement or information statement (or, 5605(f)(2) due to a vacancy on its board if the company does not file a proxy, its if the company does not file a proxy, its of directors, would have until the later Form 10–K or 20–F) for the company’s Form 10–K or 20–F) for the company’s of (i) one year from the date of vacancy annual shareholders meeting during the second annual meeting of shareholders or (ii) the date the company files its calendar year of the Second NGS/NGM subsequent to the company’s listing.34 proxy statement or its information Effective Date.42 Moreover, each As proposed, any newly listed Company statement (or, if the company does not company listed on NCM must have, or with a Smaller Board would be file a proxy, its Form 10–K or 20–F) in explain why it does not have, at least permitted to satisfy the requirement of the calendar year following the year of two Diverse directors by the later of: (i) proposed Rule 5605(f)(2) to have, or Five calendar years after the approval explain why it does not have, at least 35 See proposed Rule 5605(f)(5)(D). date of the proposal (‘‘Second NCM one Diverse director by the later of: (i) 36 The Exchange proposes to add a similar Effective Date’’); or (ii) the date the Two years from the date of listing, or (ii) provision as Rule 5810(c)(3)(F). The Exchange also company files its proxy statement or proposes to renumber existing Rules 5810(c)(3)(F) the date the company files its proxy and (G) as Rules 5810(c)(3)(G) and (H), respectively, information statement (or, if the statement or information statement (or, and to make a non-substantive change in Rule company does not file a proxy, its Form if the company does not file a proxy, its 5810(c)(2)(A)(iv) to clarify that Rule 5250(b)(3) is 10–K or 20–F) for the company’s annual Form 10–K or 20–F) for the company’s related to ‘‘Disclosure of Third Party Director and Nominee Compensation.’’ 38 See proposed Rule 5605(f)(6)(B). 37 See Rule 5810(c)(3). A company that receives 39 32 See infra note 46 and accompanying text a Staff Delisting Determination can appeal the See id. (describing Exempt Companies). determination to the Hearings Panel through the 40 See id. 33 See proposed Rule 5605(f)(5)(A). process set forth in Rule 5815. See Amendment No. 41 See proposed Rule 5605(f)(7)(A). 34 See proposed Rule 5605(f)(5)(B). 1 to the Board Diversity Proposal at 88. 42 See proposed Rule 5605(f)(7)(B).

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shareholders meeting during the The Exchange states that it has at least once per year.52 If, within the calendar year of the Second NCM published FAQs on its Listing Center to same year, a company changes its board Effective Date.43 As proposed, a provide guidance to companies on the composition after it publishes the company would not be required to application of the proposed rules in the matrix, the company may, but is not comply with the requirements of Board Diversity Proposal, and required to, publish its updated proposed Rule 5605(f) prior to the end represents that it will establish a information.53 In addition, any of the phase-in periods under proposed dedicated mailbox for companies and publication of the information in the Rule 5605(f)(5), if applicable.44 their counsel to email additional Board Diversity Matrix must be Furthermore, a company listed on NCM questions to the Exchange regarding the included in a searchable format and, if that transfers to NGS or NGM after the application of such proposed rules.47 a company uses a graphic or image approval date but prior to the end of the format (i.e., tif, jpg, gif, or png), the 2. Proposed Rule 5606 transition periods set forth in proposed company must also include the same Rule 5605(f)(7) would be required to The Exchange proposes to adopt new information as searchable text or in a satisfy the requirements of proposed Rule 5606, which would require each searchable table.54 Rule 5605(f) by the later of: (i) The Nasdaq-listed company (other than In the proposed Board Diversity periods set forth in proposed Rule Exempt Companies 48) to publicly Matrix, a company would be required to 5605(f)(7)(C); or (ii) one year from the disclose in an aggregated form, to the provide the total number of directors on date of transfer.45 extent permitted by applicable law, its board and the company (other than Proposed Rule 5605(f)(4) would information on the voluntary self- a Foreign Issuer) would include the exempt the following types of identified gender and racial following information in accordance companies from the requirements of characteristics and LGBTQ+ status of with the instructions accompanying the proposed Rule 5605(f) (‘‘Exempt the company’s board of directors.49 Board Diversity Matrix: (1) The number Companies’’): (1) Acquisition Specifically, pursuant to proposed of directors based on gender identity companies; (2) asset-backed issuers and 55 Rule 5606(a), each Nasdaq-listed (female, male, or non-binary ) and the other passive issuers (as set forth in company would be required to annually number of directors who did not Rule 5615(a)(1)); (3) cooperatives (as set disclose its board-level diversity data a disclose gender; (2) the number of forth in Rule 5615(a)(2)); (4) limited substantially similar format 50 as the directors based on race and ethnicity partnerships (as set forth in Rule (African American or Black, Alaskan 5615(a)(4)); (5) management investment ‘‘Board Diversity Matrix’’ provided in proposed Rule 5606(a).51 As proposed, Native or Native American, Asian, companies (as set forth in Rule Hispanic or Latinx, Native Hawaiian or 5615(a)(5)); (6) issuers of non-voting companies would be required to provide the Board Diversity Matrix information Pacific Islander, White, or Two or More preferred securities, debt securities, and Races or Ethnicities 56), disaggregated by derivative securities (as set forth in Rule gender identity (or did not disclose 5615(a)(6)) that do not have equity to board composition, as described in Rule 5615. See id. The Exchange also states that, although it gender); (3) the number of directors who securities listed on the Exchange; and is exempting acquisition companies from the self-identify as LGBTQ+; and (4) the (7) issuers of securities listed under the requirements of proposed Rule 5605(f), upon such number of directors who did not Rule 5700 series.46 a company’s completion of a business combination with an operating company, the post-business disclose a demographic background combination entity would be provided the same under item (2) or (3) above.57 In the 43 See proposed Rule 5605(f)(7)(C). phase-in period as other newly listed companies to proposed Board Diversity Matrix, any 44 See proposed Rule 5605(f)(7)(D). A company satisfy the requirements of proposed Rule 5605(f). director who chooses not to disclose a listing after the approval date, but prior to the end See id. at 90–91, 151. The Exchange states that this of the periods set forth in proposed Rule 5605(f)(7) approach is similar to other phase-in periods gender would be included in the ‘‘Did would be required to fully satisfy the requirements currently granted to acquisition companies. See id. Not Disclose Gender’’ category and any of proposed Rule 5605(f) by the later of the periods at 90–91. See also, e.g., Rule 5615(b)(1). under proposed Rule 5605(f)(7) or the two year director who chooses not to identify as 47 See Amendment No. 1 to the Board Diversity phase-in periods under proposed Rule 5605(f)(5). any race or ethnicity or not to identify See proposed Rule 5605(f)(7)(E). According to the Proposal at 20. 48 as LGBTQ+ would be included in the Exchange, the proposed transition and phase-in See proposed Rule 5606(c). periods are intended to provide newly-listed public 49 The Exchange states that its proposal would not 52 See Amendment No. 1 to the Board Diversity companies with additional time to meet the prevent companies from disclosing information Proposal at 326. diversity objectives of proposed Rule 5605(f)(2), as related to other diverse attributes of board members 53 newly-listed public companies may have unique beyond those highlighted in the rule if they felt See id. In addition, the Board Diversity Matrix governance structures, such as staggered boards or such disclosure would benefit investors. See must include the date the information was collected director seats held by venture capital firms, that Amendment No. 1 to the Board Diversity Proposal as the ‘‘as of date.’’ See id. require additional timing considerations when at 64. 54 The searchable information could be included, adjusting the board’s composition. See Amendment 50 As proposed, a company may not substantially for example, together with the related graphic or in No. 1 to the Board Diversity Proposal at 79. The alter the Board Diversity Matrix. However, a an appendix. See id. Exchange further states that the proposed transition company may supplement its disclosure by 55 ‘‘Non-binary’’ refers to that are not and phase-in periods are intended to provide providing additional information related to its solely man or woman; someone who is non-binary additional flexibility to companies listed on NCM, directors (e.g., a company may choose to provide may have more than one gender, have no gender, as such companies are typically smaller and may the information on a director-by-director basis or or their gender may not be in relation to the gender face additional challenges and resource constraints may choose to include any skills, experience, and binary. See id. at 327. when identifying additional director nominees who attributes of each of its directors that are relevant 56 If a director self-identifies in the ‘‘Two or More self-identify as Diverse. See id. The Exchange also to the company). Supplemental information may be Races or Ethnicities’’ category, the director must states that its proposed phase-in periods are included below the information required by the also self-identify in each individual category, as consistent with the phase-in periods it provides to Board Diversity Matrix or in a separate table. See appropriate. See id. at 66 n.174. companies for other board composition id. at 326–27. 57 The Exchange states that defined terms for the requirements. See id. at 81. See also, e.g., Rules 51 Following the first year of disclosure of the race and ethnicity categories in the instructions to 5615(b)(1), 5615(b)(3), and 5620. Board Diversity Matrix, all companies would be the Board Diversity Matrix are substantially similar 45 See proposed Rule 5605(f)(7)(F). required to include the current year and to the terms and definitions used in the EEO–1 46 The Exchange states that these companies do immediately prior year diversity statistics in the report, as described above. See supra note 17. Also, not have boards, do not list equity securities, or are disclosure. See proposed Rule 5606(a). If a company in the instructions to the Board Diversity Matrix, not operating companies. See Amendment No. 1 to publishes the Board Diversity Matrix on its website, LGTBQ+ is defined similarly to proposed Rule the Board Diversity Proposal at 90. The Exchange the disclosure must remain accessible on the 5605(f)(1) as a person who identifies as any of the also states that these companies are already exempt company’s website. See Amendment No. 1 to the following: lesbian, gay, bisexual, transgender, or a from certain corporate governance standards related Board Diversity Proposal at 326. member of the queer community.

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‘‘Did Not Disclose Demographic Date’’); or (ii) the date the company files identifies as lesbian, gay, bisexual, Background’’ category. its proxy statement or its information transgender, or as a member of the queer A company that qualifies as a Foreign statement for its annual meeting of community.65 A company that is (i) a Issuer under proposed Rule 5605(f)(1) shareholders (or, if the company does Foreign Private Issuer (as defined in may elect to use an alternative Board not file a proxy or information Rule 5005(a)(19)), or (ii) considered a Diversity Matrix format.58 Similar to statement, the date it files its Form 10– foreign issuer under Rule 3b–4(b) under other companies, a Foreign Issuer would K or 20–F) during the calendar year of the Act and has its principal executive be required to provide the total number the Effective Date. offices located outside of the United of directors on its board. The Foreign The Exchange proposes to amend States, would be an Eligible Company if Issuer would also be required to provide Rule 5810(c)(2)(A)(iv) to include a the company represents to the Exchange the following in its Board Diversity deficiency from the standards of that it does not have: (i) At least one Matrix: (1) Its country of principal proposed Rule 5606 as a deficiency for director who self-identifies as Female; executive offices; (2) whether it is a which a company may submit a plan of and (ii) at least one director who self- Foreign Private Issuer; (3) whether compliance for Exchange staff review. identifies as one or more of the disclosure is prohibited under home Accordingly, if a company fails to following: Female, an underrepresented country law; (4) the number of directors adhere to proposed Rule 5606, the individual based on national, racial, based on gender identity (female, male, Exchange would notify the company ethnic, indigenous, cultural, religious, or non-binary) and the number of that it is not in compliance with a or linguistic identity in the country of directors who did not disclose gender; listing standard and allow the company the company’s principal executive (5) the number of directors who self- 45 calendar days to submit a plan to offices, or lesbian, gay, bisexual, identify as Underrepresented regain compliance and, upon review of transgender, or as a member of the queer Individuals in home country such plan, the Exchange may provide community.66 A company that is a jurisdiction; (6) the number of directors the company with up to 180 days to Smaller Reporting Company (as defined who self-identify as LGBTQ+; and (7) regain compliance.61 If the company in Rule 12b–2 under the Act) would be the number of directors who did not does not submit a plan or regain an Eligible Company if the company disclose the demographic background compliance within the applicable time represents to the Exchange that it does under item (5) or (6) above.59 In the periods, it would be issued a Staff not have: (i) At least one director who proposed Board Diversity Matrix, any Delisting Determination, which the self-identifies as Female, and (ii) at least director who chooses not to disclose a company could appeal to a Hearings one director who self-identifies as one gender would be included in the ‘‘Did Panel pursuant to Rule 5815.62 or more of the following: Female, Black Not Disclose Gender’’ category and any or African American, Hispanic or director who chooses not to identify as B. The Board Recruiting Service Latinx, Asian, Native American or an Underrepresented Individual or not Proposal Alaska Native, Native Hawaiian or to identify as LGBTQ+ would be In order to help advance diversity on Pacific Islander, or Two or More Races included in the ‘‘Did Not Disclose company boards and to help companies or Ethnicities, or who self-identifies as Demographic Background’’ category. prepare for and, if approved, comply lesbian, gay, bisexual, transgender, or as Proposed Rule 5606(b) would require with proposed Rules 5605(f) and 5606, a member of the queer community.67 each company to provide the disclosure the Exchange proposes to provide As proposed, until December 1, 2022, required under proposed Rule 5606 in certain Nasdaq-listed companies with any Eligible Company that requests the same manner as, and concurrently one-year of complimentary access for access to this service through the with, the disclosure required by two users to a board recruiting solution, Nasdaq Listing Center will receive proposed Rule 5605(f)(3).60 which would provide access to a complimentary access for one year from Proposed Rule 5606(d) would permit network of board-ready Diverse the initiation of the service.68 The a company newly listing on the candidates, allowing companies to Exchange states that it intends to Exchange that was not previously identify and evaluate Diverse board evaluate the service and the progress subject to a substantially similar candidates.63 According to the made in enhancing diversity and may requirement of another national Exchange, this service has an extend the program prior to its securities exchange (including through approximate retail value of $10,000 per expiration through another proposed an initial public offering, direct listing, year.64 rule change filed with the transfer from another exchange or the The Exchange proposes to offer this over-the-counter market, in connection service to any ‘‘Eligible Company,’’ 65 See proposed IM–5900–9(a). The Exchange with a spin-off or carve-out from a states that, although proposed Rule 5605(f)(2)(D) which would be defined to mean a would require a Company with a Smaller Board to company listed on the Exchange or listed company (except as described have, or explain why it does not have, at least one another exchange, or through a merger below) that represents to the Exchange Diverse director on its board, such a company with an acquisition company) to satisfy would be considered an Eligible Company if it does that it does not have: (i) At least one not have at least one director who self-identifies as the requirement of proposed Rule 5606 director who self-identifies as Female; female and at least one director who self-identifies within one year of listing on the and (ii) at least one director who self- as an Underrepresented Minority or LGBTQ+, Exchange. identifies as one or more of the which the Exchange believes would help promote Pursuant to Rule 5606(e), proposed following: Black or African American, greater diversity on boards of all sizes. See Rule 5606 would become operative one Amendment No. 1 to the Board Recruiting Service Hispanic or Latinx, Asian, Native Proposal at 11 n.20. year after a Commission approval of the American or Alaska Native, Native 66 See proposed IM–5900–9(b). proposal. A company would be required Hawaiian or Pacific Islander, or Two or 67 See proposed IM–5900–9(c). The Exchange to be in compliance with proposed Rule More Races or Ethnicities, or who self- states that a company that is not an Eligible 5606 by the later of: (i) One calendar Company would be able to receive complimentary 90-day access to the board recruiting solution, year from the approval date (‘‘Effective 61 See Rule 5810(c)(2). which is being offered by Nasdaq’s partner to all 62 See id. clients of Nasdaq, Inc., including non-listed 58 See proposed Rule 5606(a). 63 See proposed IM–5900–9; Amendment No. 1 to companies. See Amendment No. 1 to the Board 59 See id. the Board Recruiting Service Proposal at 10–11. Recruiting Service Proposal at 12 n.21. 60 See supra notes 30–31 and accompanying text. 64 See proposed IM–5900–9. 68 See proposed IM–5900–9.

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Commission.69 The Exchange states that a positive association between gender Exchange further states that such no other company would be required to diversity and important investor discussions reinforced the notion that if pay higher fees as a result of its Board protections,75 and some academics companies recruit by skill set and Recruiting Service Proposal and assert that such findings may extend to experience rather than title, they would represents that providing the proposed other forms of diversity, including racial find that there is more than enough complimentary service would have no and ethnic diversity.76 The Exchange diverse talent to satisfy demand.81 impact on the resources available for its also states that it has reviewed studies Moreover, the Exchange states that regulatory programs.70 suggesting that board diversity could current reporting of board diversity data enhance a company’s ability to monitor is not provided in a consistent manner III. The Exchange’s Arguments in the or on a sufficiently widespread basis Proposals and the Comment and management by reducing ‘‘groupthink’’ and improving decision-making.77 and, as such, investors are not able to Response Letters Received on the readily compare board diversity Proposals The Exchange states that, while some companies have made progress in statistics across companies.82 In A. Summary of the Exchange’s diversifying their boardrooms,78 the pointing out the ‘‘broad latitude’’ Arguments in the Proposals national market system and the public afforded to companies by Commission rules relating to board diversity and 1. The Board Diversity Proposal interest would be well-served by a ‘‘disclosure-based, business driven’’ proxy disclosure, the Exchange states In support of the Board Diversity framework for companies to embrace that the absence of a specific definition Proposal, the Exchange states that it has meaningful and multi-dimensional of ‘‘diversity’’ for such disclosures has reviewed dozens of empirical studies diversification of their boards.79 The resulted in current reporting of board- and found that an extensive body of Exchange states that its discussions with level diversity statistics being empirical research demonstrates that organizational leaders representing a significantly unreliable and unusable to diverse boards are positively associated broad spectrum of market participants investors.83 The Exchange states that the with improved corporate governance lack of transparency creates barriers to 71 and stakeholders (including business, and company performance. While the investor, governance, legal, and civil investment analysis, due diligence, and Exchange acknowledges that some rights communities) revealed strong academic study, and is impacting studies have mixed results on this support for disclosure requirements that investors who are increasingly basing issue—for example, some studies have would standardize the reporting of public advocacy, proxy voting, and found that board gender and ethnic board diversity statistics.80 The direct shareholder-company engagement diversity has a non-significant decisions on board diversity 84 relationship or no relationship with a 75 See id. at 29, Section 3.a.III.B. The Exchange considerations. 72 company’s performance —the states that studies have found that gender-diverse Exchange believes that, at a minimum, boards or audit committees are associated with: diverse board members. See id. In addition, the the academic and empirical studies More transparent public disclosures and less Exchange states that leaders from the legal support the conclusion that board information asymmetry; better reporting discipline community emphasized that any proposed rule by management; a lower likelihood of manipulated change that imposed additional burdens beyond, or diversity does not have adverse effects earnings through earnings management; an is inconsistent with, existing securities laws would on company performance.73 increased likelihood of voluntarily disclosing present an additional burden and potentially more The Exchange also states that there is forward-looking information; a lower likelihood of legal liability for listed companies. See id. at 46– substantial evidence that board diversity receiving audit qualifications due to errors, non- 47. promotes investor protection, including compliance, or omission of information; and a 81 See id. at 19–20, 46. According to the lower likelihood of securities fraud. See id. at 13, Exchange, studies suggest that the traditional by enhancing the quality of a company’s Section 3.a.III.B. In addition, the Exchange states director candidate selection process may create financial reporting, internal controls, that studies found that having at least one woman barriers to considering qualified diverse candidates public disclosures, and management on the board is associated with a lower likelihood for board positions (e.g., directors looking within oversight.74 The Exchange states that of material weaknesses in internal control over their own social networks for candidates with financial reporting and a lower likelihood of previous C-suite experience). See id. at 41–44, more than a dozen studies have found material financial restatements. See id. at 13, Section 3.b.II.A. Section 3.a.III.B, Section 3.b.II.B. 82 See id. at 9. The Exchange also states that, 69 See Amendment No. 1 to the Board Recruiting 76 See id. at 29, Section 3.a.III.B. while conducting research on the state of board Service Proposal at 12. 77 See id. at Section 3.a.III.C. diversity among its listed companies, it 70 See id. 78 The Exchange believes that a supermajority of encountered multiple key challenges, such as: (1) 71 See Amendment No. 1 to the Board Diversity listed companies have at least one woman on the Inconsistent disclosure and definitions of Proposal at 13. The Exchange states that studies board and that listed companies are diligently ‘‘diversity’’ across companies; (2) limited data on have identified positive relationships between working to add directors with other diverse diverse characteristics outside of gender; (3) board diversity and commonly used financial attributes. See id. at 12, 41. The Exchange states inconsistent or no disclosure of a director’s race, metrics, including higher returns on invested that, while gender diversity has improved among ethnicity, or other diversity attributes (e.g., capital, returns on equity, earnings per share, U.S. company boards in recent years, the pace of nationality); (4) difficult-to-extract data because earnings before interest and taxation margin, asset change has been gradual and the U.S. still lags statistics are often embedded in graphics; and (5) valuation multiples, and credit ratings. See id. at 13, behind jurisdictions that have focused on board aggregation of information, making it difficult to Section 3.a.III.A. The Exchange also points to a diversity. See id. at 12, Section 3.a.IV. The separate gender from other categories of diversity. report that suggests that the relationship between Exchange also states that progress toward bringing See id. at 51. See also id. at 59, 107 (stating that board gender diversity and corporate performance underrepresented racial and ethnic groups into the the current lack of transparency and consistency may extend to LGBTQ+ diversity. See id. at 25. boardroom has been slower. See id. at 12, Section makes it difficult for the Exchange and investors to 72 See id. at 25–27. 3.a.IV. determine the state of diversity among listed 73 See id. at 28. The Exchange also states that this 79 See id. at 8–9. companies and each board’s philosophy regarding is not the first time it has considered whether, on 80 See id. at Section 3.a.V. The Exchange also diversity; to the extent investors must obtain this balance, various studies finding mixed results states that the majority of the organizations were in information on their own through an imperfect related to board composition and company agreement that companies would benefit from a process, this increases information asymmetries performance are a sufficient rationale to propose a disclosure-based, business-driven framework to between larger and smaller stakeholders; and a listing rule. See id. The Exchange states that, for drive meaningful and systemic change in board broader definition of diversity may result in certain example, in 2003, notwithstanding the various diversity, and that a disclosure-based approach diverse candidates being overlooked and may findings of studies at the time regarding the would be more palatable to the U.S. business hinder meaningful progress on improving diversity relationship between company performance and community than a mandate. See id. at 46. related to race, ethnicity, sexual orientation, and board independence, it adopted listing rules According to the Exchange, some in the group gender identity). requiring a majority independent board. See id. pointed out that smaller companies and companies 83 See id. at Sections 3.a.VI.A–B. 74 See id. at 29. in certain industries may face challenges finding 84 See id. at 51–52.

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The Exchange states that it is well of the traditional director recruitment The Exchange believes that the positioned to establish practices that process.91 The Exchange also believes disclosures required by proposed Rule would assist in carrying out its mandate that boards that choose to meet the 5606 and the accompanying format to protect investors and remove proposed diversity objectives may requirements would protect investors by impediments from the market through experience benefits from diversity that eliminating data collection inaccuracies, the Board Diversity Proposal.85 The perfect the mechanism of a free and decreasing investors’ costs, and Exchange believes that it is well within open market and a national market enhancing investors’ ability to utilize its delegated authority to propose listing system, and promote investor protection the information disclosed.96 The rules designed to enhance transparency, and the public interest.92 Moreover, the Exchange also believes that proposed provided that they do not conflict with Exchange believes that, to the extent a Rule 5606 would protect investors that existing federal securities laws.86 The company chooses not to meet the view information related to board Exchange also states that the proposal is proposed diversity objectives, the diversity as material to their investment related to corporate governance disclosure under proposed Rule and voting decisions, and enhance standards for listed companies and is 5605(f)(3) would provide analysts and investor confidence by assisting therefore not designed to regulate by investors with a better understanding investors in making more informed virtue of any authority conferred by the about a company’s reasons for not doing decisions.97 Moreover, the Exchange Act matters not related to the purposes so and its philosophy regarding believes that the proposed annual of the Act or the administration of the diversity.93 The Exchange believes that disclosures would provide consistent Exchange.87 While the Exchange this disclosure would enable the information to the public and would recognizes that U.S. states are investment community to conduct more enable investors to continually review increasingly proposing and adopting informed analyses of, and have more the board composition of a company to board diversity requirements, the informed conversations with, track trends,98 as well as simplify or Exchange states that certain of its companies, and improve the quality of eliminate the need for a company to current corporate governance listing information available to investors who respond to multiple investor requests rules relate to areas that are also rely on this information to make for board diversity information.99 The regulated by states (e.g., quorums, informed investment and voting Exchange also believes that the shareholder approval of certain decisions.94 In addition, the Exchange proposed timing for the board transactions).88 The Exchange also believes that the proposed disclosure composition disclosures would align states that adopting Exchange rules framework and phase-in and transition with other governance-related relating to such matters (and the periods under Rule 5605(f) recognize disclosures (e.g., those provided in the proposed rule changes described herein) the differences (e.g., in demographics or proxy) and would make it easier for would ensure uniformity of such rules resources) among different types of investors to know where a company has among its listed companies.89 companies and would not unfairly provided the disclosures and give The Exchange believes that the discriminate among companies.95 shareholders access to the information disclosure-based framework of proposed Rule 5605(f) may influence corporate 91 See id. For these reasons, the Exchange believes burden on competition among issuers that is not conduct if a company chooses to meet that proposed Rule 5605(f) is designed to remove necessary or appropriate in furtherance of the the proposed diversity objectives,90 and impediments to a free and open market and a purposes of the Act and would not impose any could help increase opportunities for national market system. See id. The Exchange also burden on competition among listing exchanges). states that proposed Rule 5605(f) is not designed to 96 See id. at 110. The Exchange also believes that Diverse candidates who otherwise may create additional impediments to a free and open it would be in the public interest to utilize the be overlooked due to the impediments market and a national market system because it Board Diversity Matrix format because it would would empower companies to maintain decision- remove impediments in aggregating and analyzing 85 See id. at 53. The Exchange also states that the making authority over the composition of their data across all companies. See id. at 113. The Board Diversity Proposal leverages the Exchange’s boards. See id. at 122. Exchange additionally believes that it would be unique ability, as a self-regulatory organization 92 See id. at Sections 3.b.II.B–C. The Exchange reasonable and in the public interest to allow (‘‘SRO’’), to influence corporate governance in also believes that including diverse directors with companies the flexibility of supplementing their furtherance of the goal of Section 342 of the Dodd- a broader range of skills, perspectives, and disclosure by providing additional information Frank Wall Street Reform and Consumer Protection experiences may help detect and prevent fraudulent related to their directors (beyond what is required Act of 2010. See id. at 18. and manipulative acts and practices by mitigating by proposed Rule 5606) in the Board Diversity 86 See id. at 58. The Exchange states that, for ‘‘groupthink’’ and enhancing the functioning of Matrix. See id. The Exchange also states that its example, it already requires its listed companies to boards, and may reduce the likelihood of insider proposed definition of ‘‘Diverse’’ would be familiar publicly disclose compensation or other payments trading and other fraudulent and manipulative acts to most companies and that the proposed Board by third parties to a company’s directors or and practices. See id. at 123–29. In addition, the Diversity Matrix would provide for standardized nominees, notwithstanding that such disclosure is Exchange states that it recognizes that directors may disclosures. See id. at 114. Moreover, the Exchange not required by federal securities laws. See id. at bring diverse perspectives, skills, and experiences believes that prohibiting companies from providing 58–59. The Exchange also states that it has designed to the board, notwithstanding that they have similar the information through graphics and images would the proposal to avoid a conflict with existing attributes; therefore, the Exchange believes that it is allow investors to easily disaggregate the data and disclosure requirements under Regulation S–K and in the public interest to permit a company to choose track directors with multiple diversity mitigate additional burdens for companies by whether to meet the proposed diversity objectives characteristics. See id. at 113. providing them with flexibility to provide such or explain why it does not. See id. at 129–30. 97 See id. at 110–11. In addition, the Exchange disclosure on their website, in their proxy statement 93 See id. at 122. The Exchange also believes that states that the proposed disclosure format would or information statement, or, if a company does not the proposal could help lower information provide a company with a uniform template with file a proxy, in its Form 10–K or 20–F, and by not asymmetry and reduce the risk of insider trading or the flexibility to include any additional details requiring companies to adopt a diversity policy. See opportunistic insider behavior, which would help about its board that the company believes would be id. at 60. to make stock prices more informative and enhance useful to investors. See id. at 111. 87 See id. at Section 3.b.II.E. stock liquidity, and is therefore designed to protect 98 The Exchange also states that the disclosures 88 See id. at 155–56. The Exchange recognizes that investors and promote capital formation and under proposed Rule 5606 would provide a means several states have enacted or proposed legislation efficiency. See id. at 135. for the Exchange to assess whether companies meet relating to board diversity and that Congress is 94 The Exchange believes that, therefore, the the diversity objectives under proposed Rule considering legislation to require Commission- proposal is designed to remove impediments to and 5605(f), which would protect investors and the registered companies to provide board diversity perfect the mechanism of a free and open market public interest. See id. at 116. statistics and disclose whether they have a board and a national market system, and to promote 99 See id. at 112. The Exchange also believes that diversity policy. See id. at 16. capital formation and efficiency. See id. at 122–23. the proposed disclosures would make information 89 See id. at 156. 95 See id. at Section 3.b.II.D. See also id. at 161– available to investors who otherwise would not be 90 See id. at 121. 63 (stating that the proposal would not impose any able to obtain individualized disclosures. See id.

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prior to a company’s annual The Exchange further argues that it is IV. Proceedings To Determine Whether shareholders meeting.100 Finally, the reasonable and not unfairly To Approve or Disapprove SR– Exchange believes that proposed Rule discriminatory to offer the board NASDAQ–2020–081 and SR–NASDAQ– 5606 would provide appropriate recruiting solution only to Eligible 2020–082, as Modified by Amendments flexibility for Foreign Issuers 101 and Companies because the Exchange No. 1, and Grounds for Disapproval appropriate exceptions for certain types believes these companies have the Under Consideration 102 of Nasdaq-listed companies, and greatest need to identify Diverse board The Commission is instituting would provide reasonable compliance candidates, particularly if these proceedings pursuant to Section periods because it would impose only a companies elect to meet the diversity 19(b)(2)(B) of the Act 113 to determine 103 de minimis burden on companies. objectives in the Board Diversity whether the proposed rule changes, as 2. The Board Recruiting Service Proposal, if approved, rather than modified by Amendments No. 1, should Proposal disclosing why they have not met the be approved or disapproved. Institution objectives.107 Additionally, the of such proceedings is appropriate at In support of the Board Recruiting Exchange believes that companies that this time in view of the issues raised by Service Proposal, the Exchange argues already have two Diverse directors have the proposed rule changes. Institution of that offering a board recruiting solution demonstrated by their current board proceedings does not indicate that the would assist and encourage listed composition that they do not need Commission has reached any companies to increase diverse additional assistance provided by the conclusions with respect to any of the representation on their boards, which Exchange to identify Diverse candidates issues involved. Rather, as described the Exchange believes could result in for their boards.108 The Exchange also below, the Commission seeks and improved corporate governance, believes that offering this encourages interested persons to strengthening of market integrity, and complimentary service would help it provide additional comment on the improved investor confidence.104 The compete to attract and retain listings, proposed rule changes, as modified by Exchange further states that offering this particularly in light of the additional Amendments No. 1, to inform the service would help companies to requirements in the Board Diversity Commission’s analysis of whether to achieve compliance with the Board Proposal that would apply to Exchange- approve or disapprove the proposed Diversity Proposal, if it were listed companies, if it were approved.109 rule changes, as modified by approved.105 The Exchange also states The Exchange further represents that Amendments No. 1. that utilization of the complimentary individual listed companies would not Pursuant to Section 19(b)(2)(B) of the board recruiting solution would be be given specially negotiated packages Act,114 the Commission is providing optional, and no company would be of products or services to list, or remain notice of the grounds for disapproval required to use the service.106 listed.110 under consideration. As described above, the Exchange proposes in the 100 See id. at 115. See also id. at 135 (stating a B. The Comment and Response Letters Board Diversity Proposal to require each similar belief with respect to the disclosures under Received on the Proposals proposed Rule 5605(f)). The Exchange also states of its listed companies, subject to that proposed Rule 5606(b) would closely align the The Commission has received certain exceptions, to: (i) Provide timing for companies that choose to disclose the comment letters that support the statistical information regarding the Board Diversity Matrix data on their websites and proposals, comment letters that suggest companies that choose to provide the data through diversity characteristics among the a Commission filing. See id. at 115. changes to the proposals, and comment members of the company’s board of 101 See id. at 115–16. letters that oppose the proposals.111 The directors; and (ii) if the company does 102 See id. at 117–18. Commission has also received two not meet the applicable board diversity 103 See id. at 118. See also id. at 159–60 (stating response letters from the Exchange.112 objectives, to disclose an explanation as that the Exchange faces competition in the market to why. Also as described above, the for listing services, and the Exchange’s belief that 107 there would be a de minimis time and economic See id. Exchange proposes in the Board 108 burden on listed companies to collect and disclose See id. at 13–14. As described above, although Recruiting Service Proposal to provide proposed Rule 5605(f)(2)(D) would require a the diversity statistical data under proposed Rule certain Nasdaq-listed companies with 5606, and that any burden placed on companies to Company with a Smaller Board to have, or explain gather and disclose this information would be why it does not have, at least one Diverse director one-year of complimentary access to a counterbalanced by the benefits that the on its board, such a company would be considered diverse board candidate recruiting information would provide to a company’s an Eligible Company if it does not have at least one solution. In addition, as stated above, director who self-identifies as female and at least investors). In the Board Diversity Proposal, the the Commission has received comment Exchange also describes the alternatives that it one director who self-identifies as an considered, including: (1) Mandate-based and Underrepresented Minority or LGBTQ+, which the letters that support the proposals, disclosure-based approaches; (ii) higher and lower Exchange believes would help promote greater comment letters that suggest changes to diversity objectives; (iii) longer and shorter diversity on boards of all sizes. See id. at 11 n.20. the proposals, and comment letters that 109 compliance timeframes; and (iv) broader and See id. at 14. oppose the proposals, as well as two narrower definitions of ‘‘Diverse.’’ See id. at Section 110 See id. at 15. 3.a.VII.D. 111 Comments received on the Board Diversity response letters from the Exchange. 104 See Amendment No. 1 to the Board Recruiting Proposal are available on the Commission’s website Moreover, on February 26, 2021, the Service Proposal at 10. The Exchange reiterates that, at: https://www.sec.gov/comments/sr-nasdaq-2020- Exchange submitted an amendment to in researching the Board Diversity Proposal, it has 081/srnasdaq2020081.htm. Comments received on each of the proposals. reviewed dozens of empirical studies and found the Board Recruiting Service Proposal are available The Commission is instituting that an extensive body of academic and empirical on the Commission’s website at: https:// research demonstrates diverse boards are positively www.sec.gov/comments/sr-nasdaq-2020-082/ proceedings to allow for additional associated with improved corporate governance and srnasdaq2020082.htm. analysis of, and input from commenters company performance. See id. at 6. Moreover, the 112 See letter from Stephen J. Kastenberg, Ballard with respect to, the consistency of the Exchange states that investors and investor groups Spahr LLP, to Vanessa Countryman, Secretary, proposals, as modified by Amendments are calling for diversification in the boardroom, and Commission, dated February 5, 2021 (submitted on legislators at the federal and state level are behalf of the Exchange by its counsel), available at: increasingly taking action to encourage or mandate https://www.sec.gov/comments/sr-nasdaq-2020- dated February 26, 2021, available at: https:// corporations to diversify their boards and improve 081/srnasdaq2020081-8343758-228925.pdf; letter www.sec.gov/comments/sr-nasdaq-2020-081/ diversity disclosures. See id. at 9–10. from John A. Zecca, Executive Vice President, Chief srnasdaq2020081-8425992-229601.pdf. 105 See id. at 10. Legal Officer, and Chief Regulatory Officer, Nasdaq, 113 15 U.S.C. 78s(b)(2)(B). 106 See id. at 13. to Vanessa A. Countryman, Secretary, Commission, 114 Id.

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No. 1, with Section 6(b)(5) of the Act,115 request for an opportunity to make an received will be posted without change. which requires that the rules of a oral presentation.122 Persons submitting comments are national securities exchange be Interested persons are invited to cautioned that we do not redact or edit designed, among other things, to submit written data, views, and personal identifying information from prevent fraudulent and manipulative arguments regarding whether the comment submissions. You should acts and practices, to promote just and proposals, as modified by Amendments submit only information that you wish equitable principles of trade, to remove No. 1, should be approved or to make available publicly. All impediments to and perfect the disapproved by April 6, 2021. Any submissions should refer to File mechanism of a free and open market person who wishes to file a rebuttal to Number SR–NASDAQ–2020–081 or SR– and a national market system and, in any other person’s submission must file NASDAQ–2020–082 and should be general, to protect investors and the that rebuttal by April 20, 2021. submitted by April 6, 2021. Rebuttal public interest, and not be designed to Comments may be submitted by any of comments should be submitted by April permit unfair discrimination between the following methods: 20, 2021. customers, issuers, brokers, or dealers, Electronic Comments For the Commission, by the Division of or to regulate by virtue of any authority • Use the Commission’s internet Trading and Markets, pursuant to delegated conferred by the Act matters not related authority.123 comment form (http://www.sec.gov/ to the purposes of the Act or the J. Matthew DeLesDernier, administration of the exchange; and rules/sro.shtml); or • Send an email to rule-comments@ Assistant Secretary. Section 6(b)(8) of the Act,116 which sec.gov. Please include File Number SR– [FR Doc. 2021–05343 Filed 3–15–21; 8:45 am] requires that the rules of a national NASDAQ–2020–081 or SR–NASDAQ– BILLING CODE 8011–01–P securities exchange not impose any 2020–082 on the subject line. burden on competition that is not necessary or appropriate in furtherance Paper Comments SECURITIES AND EXCHANGE of the purposes of the Act. The • Send paper comments in triplicate COMMISSION Commission is instituting proceedings to Secretary, Securities and Exchange to also allow for additional analysis of, [SEC File No. 270–267, OMB Control No. Commission, 100 F Street NE, 3235–0272] and input from commenters with Washington, DC 20549–1090. respect to, the consistency of the Board All submissions should refer to File Submission for OMB Review; Recruiting Service Proposal, as modified Number SR–NASDAQ–2020–081 or SR– Comment Request by Amendment No. 1, with Section NASDAQ–2020–082. This file number 117 6(b)(4) of the Act, which requires that should be included on the subject line Upon Written Request, Copies Available the rules of a national securities if email is used. To help the From: Securities and Exchange exchange provide for the equitable Commission process and review your Commission, Office of FOIA Services, allocation of reasonable dues, fees, and comments more efficiently, please use 100 F Street NE, Washington, DC other charges among its members and only one method. The Commission will 20549–2736 issuers and other persons using its post all comments on the Commission’s Extension: facilities. internet website (http://www.sec.gov/ Rule 11a–2 V. Procedure: Request for Written rules/sro.shtml). Copies of the Notice is hereby given that, pursuant Comments submission, all subsequent to the Paperwork Reduction Act of 1995 amendments, all written statements (44 U.S.C. 3501 et seq.), the Securities The Commission requests that with respect to the proposed rule interested persons provide written and Exchange Commission (the changes that are filed with the ‘‘Commission’’) has submitted to the submissions of their views, data, and Commission, and all written arguments with respect to the issues Office of Management and Budget a communications relating to the request for extension of the previously identified above, as well as any other proposed rule changes between the concerns they may have with the approved collection of information Commission and any person, other than discussed below. proposals. In particular, the those that may be withheld from the Commission invites the written views of Rule 11a–2 (17 CFR 270.11a–2) under public in accordance with the the Investment Company Act of 1940 interested persons concerning whether provisions of 5 U.S.C. 552, will be the proposals, as modified by (15 U.S.C. 80a–1 et seq.) permits certain available for website viewing and registered insurance company separate Amendments No. 1, are consistent with printing in the Commission’s Public 118 119 accounts, subject to certain conditions, Sections 6(b)(4), 6(b)(5) and Reference Room, 100 F Street NE, 6(b)(8) 120 of the Act or any other to make exchange offers without prior Washington, DC 20549, on official approval by the Commission of the provision of the Act, or the rules and business days between the hours of regulations thereunder. Although there terms of those offers. Rule 11a–2 10:00 a.m. and 3:00 p.m. Copies of the requires disclosure, in certain do not appear to be any issues relevant filing also will be available for to approval or disapproval that would registration statements filed pursuant to inspection and copying at the principal the Securities Act of 1933 (15 U.S.C. 77a be facilitated by an oral presentation of office of the Exchange. All comments views, data, and arguments, the et seq.) of any administrative fee or sales load imposed in connection with an Commission will consider, pursuant to 122 Section 19(b)(2) of the Act, as amended by the exchange offer. Rule 19b–4 under the Act,121 any Securities Acts Amendments of 1975, Public Law 94–29 (June 4, 1975), grants the Commission There are currently 676 registrants 115 15 U.S.C. 78f(b)(5). flexibility to determine what type of proceeding— governed by Rule 11a–2. The 116 15 U.S.C. 78f(b)(8). either oral or notice and opportunity for written Commission includes the estimated comments—is appropriate for consideration of a 117 15 U.S.C. 78f(b)(4). burden of complying with the particular proposal by a self-regulatory 118 Id. organization. See Securities Acts Amendments of information collection required by Rule 119 15 U.S.C. 78f(b)(5). 1975, Senate Comm. on Banking, Housing & Urban 120 15 U.S.C. 78f(b)(8). Affairs, S. Rep. No. 75, 94th Cong., 1st Sess. 30 123 17 CFR 200.30–3(a)(12); 17 CFR 200.30– 121 17 CFR 240.19b–4. (1975). 3(a)(57).

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11a–2 in the total number of burden PLACE: The meeting will be held via SECURITIES AND EXCHANGE hours estimated for completing the remote means and/or at the COMMISSION relevant registration statements and Commission’s headquarters, 100 F reports the burden of Rule 11a–2 in the Street NE, Washington, DC 20549. [Release No. 34–91288; File No. SR–CBOE– separate Paperwork Reduction Act 2021–015] (‘‘PRA’’) submissions for those STATUS: This meeting will be closed to registration statements (see the separate the public. Self-Regulatory Organizations; Cboe Exchange, Inc.; Notice of Filing and PRA submissions for Form N–3 (17 CFR MATTERS TO BE CONSIDERED: 274.11b), Form N–4 (17 CFR 274.11c) Immediate Effectiveness of a Proposed Commissioners, Counsel to the Rule Change To Update its Fees and Form N–6 (17 CFR 274.11d). The Commissioners, the Secretary to the Commission is requesting a burden of Schedule in Connection With the Commission, and recording secretaries Exchange’s Plans To List and Trade one hour for Rule 11a–2 for will attend the closed meeting. Certain administrative purposes. Options on the Mini-RUT Index staff members who have an interest in (‘‘MRUT’’ or ‘‘Mini-RUT’’) The estimate of average burden hours the matters also may be present. is made solely for the purposes of the In the event that the time, date, or March 10, 2021. PRA, and is not derived from a Pursuant to Section 19(b)(1) of the comprehensive or even a representative location of this meeting changes, an announcement of the change, along with Securities Exchange Act of 1934 (the survey or study of the costs of ‘‘Act’’),1 and Rule 19b–4 thereunder,2 the new time, date, and/or place of the Commission rules or forms. With regard notice is hereby given that on March 1, meeting will be posted on the to Rule 11a–2, the Commission includes 2021, Cboe Exchange, Inc. (the the estimate of burden hours in the total Commission’s website at https:// ‘‘Exchange’’ or ‘‘Cboe Options’’) filed number of burden hours estimated for www.sec.gov. with the Securities and Exchange completing the relevant registration The General Counsel of the Commission (the ‘‘Commission’’) the statements and reported on the separate Commission, or his designee, has proposed rule change as described in PRA submissions for those statements certified that, in his opinion, one or Items I, II, and III below, which Items (see the separate PRA submissions for more of the exemptions set forth in 5 have been prepared by the Exchange. Form N–3, Form N–4 and Form N–6). U.S.C. 552b(c)(3), (5), (6), (7), (8), 9(B) The Commission is publishing this The information collection and (10) and 17 CFR 200.402(a)(3), notice to solicit comments on the requirements imposed by Rule 11a–2 (a)(5), (a)(6), (a)(7), (a)(8), (a)(9)(ii) and proposed rule change from interested are mandatory. Responses to the persons. collection of information will not be (a)(10), permit consideration of the kept confidential. An agency may not scheduled matters at the closed meeting. I. Self-Regulatory Organization’s conduct or sponsor, and a person is not The subject matter of the closed Statement of the Terms of Substance of required to respond to, a collection of meeting will consist of the following the Proposed Rule Change information unless it displays a topics: Cboe Exchange, Inc. (the ‘‘Exchange’’ currently valid control number. Institution and settlement of or ‘‘Cboe Options’’) proposes to update The public may view background injunctive actions; its Fees Schedule in connection with documentation for this information Institution and settlement of the Exchange’s plans to list and trade collection at the following website: options on the Mini-RUT Index administrative proceedings; www.reginfo.gov. Find this particular (‘‘MRUT’’ or ‘‘Mini-RUT’’). The text of information collection by selecting Resolution of litigation claims; and the proposed rule change is provided in ‘‘Currently under 30-day Review—Open Other matters relating to examinations Exhibit 5. for Public Comments’’ or by using the and enforcement proceedings. The text of the proposed rule change search function. Written comments and is also available on the Exchange’s At times, changes in Commission recommendations for the proposed website (http://www.cboe.com/ priorities require alterations in the information collection should be sent AboutCBOE/ scheduling of meeting agenda items that within 30 days of publication of this CBOELegalRegulatoryHome.aspx), at notice to (i) www.reginfo.gov/public/do/ may consist of adjudicatory, the Exchange’s Office of the Secretary, PRAMain and (ii) David Bottom, examination, litigation, or regulatory and at the Commission’s Public Director/Chief Information Officer, matters. Reference Room. Securities and Exchange Commission, c/ CONTACT PERSON FOR MORE INFORMATION: o Cynthia Roscoe, 100 F Street NE, II. Self-Regulatory Organization’s For further information; please contact Washington, DC 20549, or by sending an Statement of the Purpose of, and Vanessa A. Countryman from the Office email to: [email protected]. Statutory Basis for, the Proposed Rule of the Secretary at (202) 551–5400. Change Dated: March 11, 2021. Dated: March 11, 2021. J. Matthew DeLesDernier, In its filing with the Commission, the Vanessa A. Countryman, Assistant Secretary. Exchange included statements concerning the purpose of and basis for [FR Doc. 2021–05378 Filed 3–15–21; 8:45 am] Secretary. [FR Doc. 2021–05456 Filed 3–12–21; 11:15 am] the proposed rule change and discussed BILLING CODE 8011–01–P any comments it received on the BILLING CODE 8011–01–P proposed rule change. The text of these SECURITIES AND EXCHANGE statements may be examined at the COMMISSION places specified in Item IV below. The Exchange has prepared summaries, set Sunshine Act Meetings forth in sections A, B, and C below, of

TIME AND DATE: 2:00 p.m. on Thursday, 1 15 U.S.C. 78s(b)(1). March 18, 2021. 2 17 CFR 240.19b–4.

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the most significant aspects of such outlay of capital. As such, the Exchange • Adopts fee code MM, which is statements. will allow the same type of expirations, appended to all Market-Maker (capacity settlement and exercise style, minimum ‘‘M’’) orders in MRUT options and A. Self-Regulatory Organization’s increments, strike price intervals and assesses a fee of $0.03 per contract. The Statement of the Purpose of, and Market-Maker appointment weights for proposed fee is approximately 1/10th of Statutory Basis for, the Proposed Rule MRUT options as it currently does for the fees assessed for Market-Maker Change XSP options and anticipates that MRUT orders in RUT options ($0.30); and 1. Purpose options will have the same investor base • Adopts fee code BM, appended to 3 The Exchange proposes to amend its as XSP options. The Exchange now all Broker-Dealer (capacity ‘‘B’’), Joint Fees Schedule in connection with its proposes to amend its Fees Schedule to Back-Office (capacity ‘‘J’’), Non-TPH plans to list and trade MRUT options, accommodate the planned listing and Market-Maker (capacity ‘‘N’’), and effective March 1, 2021. trading of MRUT options. The Exchange Professional (capacity ‘‘U’’) notes that because both MRUT and XSP (collectively, ‘‘Non-Customers’’) orders Background are mini-index options intended for the in MRUT options and assesses a fee of MRUT options are options on the same investor-base, the majority of the $0.04 per contract. The proposed fee is Mini-RUT Index, the value of which is proposed changes amend the Fees approximately 1/10th of the difference 1/10th the value of the Russell 2000 Schedule in connection with trading in between the two rates assessed for Non- (‘‘RUT’’) Index. The Russell 2000 Index MRUT options in a manner that is Customer orders in RUT options ($0.25 measures the performance of small-cap generally consistent with the way in for manual and AIM transactions and segment of the U.S. equity universe. It which existing transactions fees and $0.65 for non-AIM electronic is a subset of the Russell 3000 Index and programs currently apply to trading in transactions). includes approximately 2,000 U.S.- XSP options. The Exchange also proposes to waive based securities based on a combination Standard Transaction Rates and the proposed MRUT transaction fees for of their market cap and current index Surcharges Firms and Market-Makers through membership. The Russell 2000 Index is August 31, 2021. Specifically, proposed constructed to provide a comprehensive First, the Exchange proposes to adopt footnote 32 (appended to MRUT options and unbiased small-cap barometer and certain standard transaction fees in for Market-Maker and Firm transaction is completely reconstituted annually to connection with MRUT options in a fees in the Rate Table—All Products ensure larger stocks do not distort the manner that closely aligns the fees Excluding Underlying Symbol List A) performance and characteristics of the assessed for MRUT options with that of provides that transaction fees for orders true small-cap opportunity set. The the fees assessed for RUT options. As executed in MRUT options with a Russell 2000 Index is a commonly used described above, MRUT options and capacity code of ‘‘F’’, ‘‘L’’, or ‘‘M’’ will benchmark for mutual funds that RUT options track the same underlying be waived through August 31, 2021. The identify themselves as ‘‘small-cap,’’ and index, yet MRUT options are 1/10th the proposed waiver is intended to much like the S&P 500 Index (‘‘SPX’’), size of standard RUT options contracts. encourage liquidity in a newly listed is used to benchmark large As such, the proposed rule change and traded product on the Exchange. capitalization stocks. The Exchange adopts certain fees for MRUT options in In addition to the above transaction understands that investors often use the Rate Table for All Products fees, the proposed rule change also Russell 2000 Index-related products to Excluding Underlying Symbol A 4 that adopts certain surcharges to MRUT diversify their portfolios and benefit are approximately 1/10th of the fees transactions within the Rate Table—All from market trends. RUT options currently assessed for RUT options, as Products Excluding Underlying Symbol currently offer these benefits to follows: List A. The proposed rule change investors but may be expensive given • Adopts fee code CQ, appended to applies an Index License Surcharge Fee their larger notional value and are all Customer (capacity ‘‘C’’) orders in of $0.02 to all Firm, Market-Maker and therefore primarily used by institutional MRUT options and assesses a fee of Non-Customer transactions in MRUT market participants. By contrast, MRUT $0.02 per contract. This proposed fee is options. Currently, the Index License options are reduced-value options (1/ approximately 1/10th of the fees Surcharge Fee assesses a $0.10 charge 10th) compared to RUT options that will assessed for Customer orders in RUT for transactions in DJX, MXEA and offer individual investors lower cost options ($0.18). MXEF options. The proposed lower options to obtain the potential benefits • Adopts fee code FM, appended to Index License Surcharge rate for MRUT of options on the Russell 2000 Index. all Clearing Trading Permit Holder options is intended to promote and The Exchange believes that investors (‘‘TPHs’’) (capacity ‘‘F’’) and for Non- encourage trading of MRUT options will benefit from the availability of TPH Affiliate of a Clearing TPH once listed. The Exchange notes that Mini-RUT option contracts by making (capacity ‘‘L’’) (collectively, ‘‘Firms’’) this is similar to lower (or waived) options overlying the higher-valued orders in MRUT options and assesses a Index License fees for other options RUT Index more readily available as an fee of $0.02 per contract. The proposed classes in order to similarly continue to 5 investing tool and at more affordable fee is approximately 1/10th of the fees promote their trading and growth. prices for investors. The Exchange also assessed for Firm orders in RUT options believes that the investor-base for ($0.26); 5 See e.g. Securities Exchange Act Release No MRUT options are likely to be the same 90093 (October 5, 2020), 85 FR 64189 (October 9, investor-base for Mini-SPX options 2020) (SR–CBOE–2020–088), which provides that 3 See Securities Exchange Act Release Nos. 90748 ‘‘[t]he Exchange does not at this time propose to (‘‘XSP’’), which are also proprietary, (December 21, 2020), 85 FR 85759 (December 29, assess the Index License fee on transactions in reduced-value options on a broad-based 2021) (SR–CBOE–2020–118); and 91067 (February SPESG in order to promote and encourage trading index (SPX), as they are both designed 5, 2021), 86 FR 9108 (February 11, 2021) (SR– of SPESG once listed.’’; and Securities Exchange to provide low-cost means to hedge CBOE–2020–118) [sic]. Act Release No. 87953 (January 13, 2020), 85 FR 4 Underlying Symbol List A includes OEX, XEO, 3091 (January 17, 2020) (SR–CBOE–2020–001), investors’ portfolios in connection with RUT, RLG, RLV, RUI, UKXM, SPX (includes which waived permanently the Index License fees higher-value broad-based indexes (i.e., SPXW), SPESG and VIX. See Cboe Options Fees for transactions in Sector Index options to continue the RUT and SPX Index) with a smaller Schedule, Footnote 34. to encourage their growth and trading.

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The proposed rule change adds credits on Market-Maker orders where a to contracts that are routed to one or MRUT options to the list of options, Market-Maker achieves certain volume more exchanges in connection with the which currently includes XSP, for thresholds based on total national Options Order Protection and Locked/ which the FLEX Surcharge Fee of $0.10 Market-Maker volume in all underlying Crossed Market Plan referenced in Rule (capped at $250 per trade) applies to symbols, excluding Underlying Symbol 5.67, provided the Trading Permit electronic FLEX orders executed by all List A and XSP, during the calendar Holder meets certain percentage capacity codes.6 The proposed rule month. Specifically, the proposed rule thresholds in a month as described in change adopts an Exotic Surcharge of change updates the Liquidity Provider the Volume Incentive Program (VIP) $0.03 for Customer transactions in Sliding Scale table to provide that table; the percentage thresholds are MRUT, which is consistent with the volume thresholds are based on total calculated based on the percentage of Exotic Surcharge currently assessed for national Market-Maker volume in all national customer volume in all Customer transactions in XSP. underlying symbols excluding underlying symbols excluding Additionally, the Exchange proposes to Underlying Symbol List A, MRUT and Underlying Symbol List A, Sector exclude MRUT orders from the AIM XSP during the calendar month, and Indexes, MRUT, MXEA, MXEF, DJX and Contra Fee by amending footnote 18 that it applies in all underlying symbols XSP entered and executed over the (appended to the AIM Contra Fee) to excluding Underlying Symbol List A, course of the month; and in the event provide that the AIM Contra Execution MRUT and XSP. The proposed rule of a Cboe Options System outage or Fee applies to all orders (excluding change also updates footnote 10 other interruption of electronic trading facilitation orders, per footnote 11) in all (appended to the Liquidity Provider on Cboe Options, the Exchange will products, except MRUT, XSP,7 Sector Sliding Scale) to provide that the adjust the national customer volume in Indexes and Underlying Symbol List A, Liquidity Provider Sliding Scale applies all underlying symbols excluding executed in the Automated to Liquidity Provider (Cboe Options Underlying Symbol List A, Sector Improvement Mechanism (‘‘AIM’’), Market-Maker, DPM and LMM) Indexes, MRUT, MXEA, MXEF, DJX and Solicitation Auction Mechanism transaction fees in all products except XSP for the entire trading day.10 (‘‘SAM’’), FLEX AIM and FLEX SAM (1) Underlying Symbol List A (34), The proposed rule change excludes auctions, that were initially entered as MRUT and XSP,8 and (2) volume MRUT from the list of products eligible the contra party to an Agency/Primary executed in open outcry.9 to receive Break-Up Credits in orders Order. Applicable standard transaction The proposed rule change updates the executed in AIM, SAM, FLEX AIM, and fees will apply to AIM, SAM, FLEX AIM Volume Incentive Program (‘‘VIP’’) table FLEX SAM, by amending the Break-Up and FLEX SAM executions in MRUT, to exclude MRUT volume from the VIP, Credits table to exclude MRUT along XSP, Sector Indexes and Underlying which currently offers a per contract with the products currently excluded— Symbol List A. The Exchange also credit for certain percentage threshold Underlying Symbol List A, Sector proposes to exclude Firm, Market-Maker levels of monthly Customer and Non- Indexes, DJX, MXEA, MXEF and XSP. and Non-Customer complex orders in Customer volume in all underlying The Exchange also proposes to MRUT from the Complex Surcharge by symbols, excluding Underlying Symbol exclude Firm transactions in MRUT amending footnote 35 (appended to the List A, Sector Indexes, DJX, MXEA, from the Clearing TPH Fee Cap. Complex Surcharge) to provide that the MXEF and XSP. The proposed rule Specifically, it amends footnote 22 Complex Surcharge applies per contract change also amends footnote 36 (appended to the Clearing TPH Fee Cap per side surcharge for noncustomer (appended to the VIP table) to reflect the table) to provide that all non-facilitation complex order executions that remove proposed exclusion of MRUT from the business executed in AIM or open liquidity from the COB and auction VIP by providing (in relevant part) that: outcry, or as a QCC or FLEX transaction, responses in the Complex Order The Exchange shall credit each Trading transaction fees for Clearing TPH Auction (‘‘COA’’) and AIM in all classes Permit Holder the per contract amount Proprietary and/or their Non-TPH except MRUT, XSP, Sector Indexes and resulting from each public customer Affiliates in all products except MRUT, Underlying Symbol List A. The (‘‘C’’ capacity code) order transmitted by XSP, Sector Indexes and Underlying proposed FLEX and Exotic surcharges that Trading Permit Holder which is Symbol List A (which includes SPX), in and exclusion from the AIM Contra Fee executed electronically on the Exchange the aggregate, are capped at $55,000 per (and, instead, the application of the in all underlying symbols excluding month per Clearing TPH. It additionally proposed standard transaction fees) and Underlying Symbol List A, Sector updates footnote 11 (which is also Complex Surcharge in connection with Indexes, DJX, MRUT, MXEA, MXEF, appended to the Clearing TPH Fee Cap transactions in MRUT will provide XSP, QCC trades, public customer to table) to provide that the Clearing TPH consistency with the fees and public customer electronic complex Fee Cap in all products except MRUT, exclusions currently applicable to order executions, and executions related XSP, Underlying Symbol List A and transactions in XSP. Sector Indexes (the ‘‘Fee Cap’’),11 among 8 The proposed rule change corrects an Fees Programs inadvertent grammatical error in footnote 10 in other programs, apply to (i) Clearing The proposed rule change excludes connection with the exclusion of XSP from the TPH proprietary orders (‘‘F’’ capacity MRUT volume from the Liquidity Liquidity Provider Sliding Scale. code), and (ii) orders of Non-TPH 9 The proposed rule change also updates footnote Affiliates of a Clearing TPH. Provider Sliding Scale, which offers 6, which is appended to the Liquidity Provider Sliding Scale Program, the VIP, and the ORS/CORS The Exchange proposes to exclude 6 The FLEX Surcharge Fee will only be charged Programs to reflect the exclusion of MRUT options MRUT from eligibility for the Order up to the first 2,500 contracts per trade. See Cboe from these programs in the same manner as the Router Subsidy (‘‘ORS’’) and Complex Options Fees Schedule, Footnote 17. options classes currently excluded from these Order Router Subsidy (‘‘CORS’’) 7 The proposed rule change also makes clear in programs. Specifically, amended footnote 6 Programs, in which Participating TPHs the first sentence of footnote 18 that the AIM Contra provides that in the event of a Cboe Options System Execution Fee is not applicable to transaction in outage or other interruption of electronic trading on XSP. This is currently the case and is clear in the Cboe Options that lasts longer than 60 minutes, the 10 See supra note 8. subsequent language within footnote 18 as well as Exchange will adjust the national volume in all 11 The Exchange notes that it also corrects an the manner in which the fees are presented in Rate underlying symbols excluding Underlying Symbol error in footnote 11 by moving the abbreviated Table—All Products Excluding Underlying Symbol List A, Sector Indexes, MRUT, MXEA, MXEF, DJX definition for the Clearing TPH Fee Cap (‘‘Fee Cap’’) List A. and XSP for the entire trading day. [sic], to the end of the clause describing the cap.

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or Participating Non-Cboe TPHs may The Exchange notes that excluding and trading for MRUT options to be receive a payment from the Exchange MRUT transactions from the above- eligible for the Marketing Fee Program for every executed contract routed to the described programs is consistent with and may determine in the future to Exchange through their system in the manner in which XSP transactions submit a fee filing to add MRUT to the certain classes. Specifically, the are also excluded each of these Marketing Fee Program if the Exchange proposed rule change updates the ORS/ programs today. believes it would potentially generate CORS Program tables to provide that Additionally, the Exchange proposes more customer order flow in MRUT. ORS/CORS participants whose total to exclude MRUT from the Marketing MRUT LMM Program aggregate non-customer ORS and CORS Fee Program by updating the Marketing volume is greater than 0.25% of the total Fee table to provide that the marketing Finally, the Exchange proposes to national volume (excluding volume in fee will be assessed on transactions of adopt a financial program for LMMs options classes included in Underlying Market-Makers (including DPMs and appointed in MRUT options. As Symbol List A, Sector Indexes, DJX, LMMs), resulting from customer orders proposed, the MRUT LMM Incentive MRUT, MXEA, MXEF or XSP) will at the per contract rate provided above Program provides that if the appointed receive an additional payment for all on all classes of equity options, options LMM in MRUT provides continuous executed contracts exceeding that on ETFs, options on ETNs and index electronic quotes during Regular threshold during a calendar month, and options, except that the marketing fee Trading Hours that meet or exceed the updates footnote 30 (appended to the shall not apply to Sector Indexes, DJX, proposed heightened quoting standards ORS/CORS Program tables) to MXEA, MXEF or Underlying Symbol (below) in at least 99% of the series accordingly provide that Cboe Options List A. The Exchange notes that, in this 90% of the time in a given month, the does not make payments under the way, MRUT will be treated as most of LMM will receive a payment for that program with respect to executed the Exchange’s other exclusively listed month in the amount of $20,000 (or pro- contracts in options classes included in products that are currently excluded rated amount if an appointment begins Underlying Symbols List A, Sector from the Marketing Fee Program. The after the first trading day of the month Indexes, DJX, MRUT, MXEA, MXEF or Exchange does believe that it is or ends prior to the last trading day of XSP.12 necessary at the point of newly listing the month).

Expiring Near term Mid term Long term Premium level 14 days or less 15 days to 60 days 61 days to 270 days 271 days or greater Width Size Width Size Width Size Width Size

$0.00–$1.00 ...... $0.08 1 $0.10 1 $0.15 1 $0.80 1 $1.01–$3.00 ...... 0.15 1 0.15 1 0.15 1 0.85 1 $3.01–$5.00 ...... 0.15 1 0.18 1 0.20 1 1.00 1 $5.01–$10.00 ...... 0.45 1 0.20 1 0.35 1 1.25 1 $10.01–$25.00 ...... 1.25 1 0.55 1 0.50 1 2.25 1 $25.01–$100.00 ...... 3.00 1 2.00 1 1.75 1 4.00 1 Greater than $100.00 ...... 8.00 1 8.00 1 8.00 1 8.00 1

Meeting or exceeding the heightened MRUT provided for that month per the 2. Statutory Basis quoting standards in MRUT, as MRUT Volume Incentive Pool program proposed, to receive the proposed below: The Exchange believes that the compensation payment is optional for proposed rule change is consistent with the objectives of Section 6 of the Act,13 an MRUT LMM. The Exchange may MRUT ADV Monthly ADV consider other exceptions to this payment in general, and furthers the objectives of quoting standard based on demonstrated Section 6(b)(4),14 in particular, as it is legal or regulatory requirements or other 0–24,999 contracts ...... $0.00 designed to provide for the equitable mitigating circumstances. In calculating 25,000–49,999 contracts ...... 25,000 allocation of reasonable dues, fees and whether an LMM met the heightened 50,000–100,000 contracts .... 35,000 other charges among its Members and quoting standard each month, the Greater than 100,000 con- issuers and other persons using its tracts ...... 50,000 Exchange will exclude from the facilities. The Exchange also believes calculation in that month the business that the proposed rule change is day in which the LMM missed meeting The heightened requirements and consistent with the objectives of Section or exceeding the heightened quoting MRUT Volume Incentive Pool offered 6(b)(5) 15 requirements that the rules of standard in the highest number of by the MRUT LMM Incentive Program an exchange be designed to prevent series. In addition to the above rebate, are designed to incentivize LMMs to fraudulent and manipulative acts and if the appointed LMM meets or exceeds provide significant liquidity in MRUT practices, to promote just and equitable the above heightened quoting standards options during the trading day upon principles of trade, to foster cooperation in a given month and provides an their listing and trading on the and coordination with persons engaged average daily volume (‘‘ADV’’) in MRUT Exchange, which, in turn, would in regulating, clearing, settling, that meets or exceeds 25,000 contracts provide greater trading opportunities, processing information with respect to, in a given month, the LMM will receive added market transparency and and facilitating transactions in the Monthly ADV Payment amount that enhanced price discovery for all market securities, to remove impediments to corresponds to the level of ADV in participants in MRUT. and perfect the mechanism of a free and

12 See supra note 8. 14 15 U.S.C. 78f(b)(4). 13 15 U.S.C. 78f. 15 15 U.S.C. 78f(b)(5).

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open market and a national market for orders in MRUT and XSP, which are Break-Up Credits table, the Clearing system, and, in general, to protect both mini-index options designed to TPH Fee cap, and the ORS/CORS investors and the public interest, and, offer investors lower cost options to programs in the same manner in which particularly, is not designed to permit obtain the potential benefits of options transactions in XSP options are unfair discrimination between on a broad-based index options and currently excluded from the same customers, issuers, brokers, or dealers. intended for the same investor-base. programs today as the Exchange Therefore, the Exchange believes it is believes it is appropriate to update these Standard Transaction Rates and appropriate to amend the Fees Schedule fees programs in a manner that similarly Surcharges in a manner that similarly situates fees situates transactions in MRUT with The Exchange believes that the assessed for orders in MRUT options transactions in XSP, as both mini-index proposed amendments to the Fees with those assessed for orders in XSP options are designed to offer investors Schedule in connection with standard options. lower cost options to obtain the transaction rates and surcharges for The Exchange believes the proposed potential benefits of options on a broad- MRUT transactions are reasonable, standard transaction rates and based index options and are intended equitable and not unfairly surcharges (or exclusions) are equitable for the same investor base. Additionally, discriminatory. Specifically, the and not unfairly discriminatory because the Exchange believes that excluding Exchange believes that it is reasonable they will apply automatically and MRUT from the Marketing Fee Program to assess fees for Customer, Market- uniformly to all Customer, Firm, is reasonable most of the Exchange’s Maker, Firm, and Non-Customer orders Market-Maker and/or Non-Customer, other proprietary products are currently in MRUT that reflect approximately 1/ orders, as applicable, in MRUT options. excluded from the Marketing Fee 10th of the transactions fees assessed for The Exchange also believes that it is Program. The Exchange does believe corresponding orders in RUT because of equitable and not unfairly that it is necessary at the point of newly the relation between MRUT options and discriminatory to waive the transaction listing and trading for MRUT RUT options, wherein MRUT options fees (through August 31, 2021) for transactions to be eligible for the overlie an index 1/10th the value of the Market-Maker and Firm orders in MRUT Marketing Fee Program and may index that underlies RUT options. because, as stated above, the Exchange determine in the future to submit a fee Additionally, the Exchange believes it is recognizes that these market filing to add MRUT to the Marketing Fee reasonable to waive the transaction fees participants can provide key and Program if the Exchange believes it for Market-Maker and Firm orders in distinct sources of liquidity, which is would potentially generate more MRUT options through August 31, 2021 particularly important for a newly listed customer order flow in MRUT options. because the waiver is designed to and traded options class on the The Exchange believes that excluding encourage order flow from these market Exchange. An increase in general MRUT transactions from certain fees participants in a newly listed and traded market-making activity facilitates tighter programs is equitable and not unfairly options class on the Exchange. The spreads, which tend to signal additional discriminatory because the programs Exchange recognizes that Market- corresponding increase in order flow will equally not apply to, or exclude in Makers and Firms each provide from other market participants, the same manner, all market important and distinct sources of ultimately incentivizing more overall participants’ orders in MRUT options. liquidity to the Exchange and increased order flow and improving liquidity The Exchange notes that the proposed liquidity provides more trading levels and price transparency on the rule change does not alter any of the opportunities, in turn, signaling Exchange to the benefit of all market existing program rates or volume additional corresponding increase in participants. Similarly, the Exchange calculations, but instead, merely order flow from other market also recognizes that Firms can be an proposes not to include transactions in participants, and, as a result, important source of liquidity when they MRUT in those programs and volume contributing towards a robust, well- facilitate their own customers’ trading calculations in the same way that balanced market ecosystem. The activity, thus, adding transparency and transactions in XSP options are not Exchange also believes that it is promoting price discovery to the benefit currently included, or, regarding the reasonable to assess a lower Index of all market participants. The Exchange Marketing Fee Program, in the same way License fee on transactions in MRUT notes too that Market-Makers and Firms transactions in most of the Exchange’s because MRUT is a new product and the take on a number of obligations that other exclusively listed products are not Exchange wishes to promote and other market participants do not have. currently included. encourage trading of MRUT once listed. For example, unlike other market MRUT LMM Program The Exchange notes that, similar to participants, Market-Makers take on assessing a lower Index License fee, the quoting obligations and other market The Exchange believes the proposed Index License fees for certain options in making requirements and Firms must MRUT LMM Incentive Program is other classes are waived in order to have higher capital requirements, clear reasonable, equitable and not unfairly continue to promote their trading and trades for other market participants, and discriminatory. Particularly, the growth.16 Moreover, the Exchange must be members of OCC. proposed MRUT LMM Incentive believes it is reasonable to assess the Program is a reasonable financial same FLEX and Exotic surcharge rates to Fees Programs incentive program because the proposed orders in MRUT as it does for XSP and The Exchange believes that the heightened quoting standards and rebate to exclude MRUT from the Complex proposed updates to the Fees Schedule amount for meeting the heightened Surcharge and AIM Contra Fee (and to in connection with the application of quoting standards in MRUT series are apply the standard transaction fees for certain fees programs to transactions in reasonably designed to incentivize an MUT orders in lieu of the AIM Contra MRUT options are reasonable, equitable appointed LMM to meet the proposed Fee) because these proposed surcharges and not unfairly discriminatory. heightened quoting standards during and surcharge exclusions will provide Particularly, the Exchange believes it is RTH for MRUT, thereby providing consistency between the fees assessed reasonable to exclude transactions in liquid and active markets, which MRUT options from the Liquidity facilitates tighter spreads, increased 16 See supra note 5. Provider Sliding Scale, the VIP, the trading opportunities, and overall

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enhanced market quality to the benefit incentive to MRUT LMMs pursuant to Surcharge), as it currently does for XSP of all market participants, particularly the proposed MRUT LMM Incentive options or as it does for the Exchange’s in a newly listed and traded product on Program, because it will benefit all other proprietary products. The the Exchange during the trading day. market participants trading MRUT Exchange does not believe that waiving The Exchange believes that the during RTH by encouraging the LMMs the MRUT transaction fees for Market- proposed heightened quoting standards to satisfy the heightened quoting Makers and Firms in the first six months are reasonable because they are similar standard, which incentivizes of MRUT options listing and trading on to the detail and format (specific continuous increased liquidity and the Exchange will impose any burden expiration categories and corresponding thereby may provide more trading on intramarket competition because premiums, quote widths, and sizes) of opportunities and tighter spreads. these participants may, as discussed the heightened quoting standards Indeed, the Exchange notes that its above, provide key and distinct sources currently in place for MSCI LMMs, LMMs serve a crucial role in providing of liquidity, which is particularly SPESG LMMs, GTH SPX/SPXW LMMs quotes and the opportunity for market important for a newly listed and traded and GTH VIX LMMs.17 For example, the participants to trade MRUT, which can options class on the Exchange. Also, expiration categories are the same as lead to increased volume, providing for Market-Makers and Firms take on a those for the GTH VIX LMM heightened robust markets. The Exchange number of obligations that other market quoting standards. The Exchange ultimately wishes to sufficiently participants do not have. Unlike other believes the proposed smaller quote incentivize LMMs to provide liquid and market participants, Market-Makers take widths and sizes in the proposed active markets in the newly listed and on quoting obligations and other market heightened quoting standards for MRUT traded MRUT options during the trading making requirements and Firms must LMMs reasonably reflect what the day to encourage liquidity, thereby have higher capital requirements, clear Exchanges believes will be typical protecting investors and the public trades for other market participants, and market characteristics in MRUT options, interest. The Exchange also notes that must be members of OCC. The Exchange given their smaller notional value and an LMM may have added costs each also does not believe that the proposed minimum increments and general retail month that it needs to undertake in LMM incentive program for MRUT base, thus smaller, retail-sized orders. order to satisfy that heightened quoting options would impose any burden on Moreover, the Exchange believes that standard (e.g., having to purchase intramarket competition because it the proposed $20,000 monthly rebate for additional logical connectivity). The applies to all LMMs appointed to MRUT an LMM that meets the proposed Exchange believes the proposed in a uniform manner, in the same way heightened quoting standards in MRUT program is equitable and not unfairly similar programs apply to LMMs in in a month is reasonable and equitable discriminatory because similar other proprietary products today. To the as it equal or comparable to the rebates programs currently exist for LMMs in extent these LMMs receive a benefit that offered for other LMM incentive other proprietary products,20 and the other market participants do not, as programs for other proprietary proposed program will equally apply to stated, LMMs have different obligations products.18 For example, the MSCI any TPH that is appointed as a MRUT and are held to different standards. For LMM Incentive Program also offers LMM. Additionally, if an LMM does not example, LMMs play a crucial role in $20,000 per month for each MSCI series satisfy the heightened quoting standard providing active and liquid markets in in which the appointed LMM meets the in MRUT for any given month, then it their appointed products, especially in given heighten quoting standards. The simply will not receive the offered the newly developing MRUT market, Exchange also believes it is reasonable payment for that month. thereby providing a robust market to offer an additional payment that B. Self-Regulatory Organization’s which benefits all market participants. corresponds to an MRUT LMM’s level of Statement on Burden on Competition Such Market-Makers also have ADV in MRUT options, if it meets the obligations and regulatory requirements heightened quoting standards, because The Exchange believes the proposed that other participants do not have. the proposed MRUT Volume Incentive amendments to its Fee Schedule will The Exchange does not believe that Pool is a volume-based incentive not impose any burden on competition the proposed rule change will impose designed to further encourage LMMs to that is not necessary or appropriate in any burden on intermarket competition provide significant liquidity in MRUT furtherance of the purposes of the Act. that is not necessary or appropriate in options during the trading day, which is The Exchange does not believe that the furtherance of the purposes of the Act particularly important for a newly listed proposed rule change will impose any because the propose fees assessed and and traded options class on the burden on intramarket competition that rebates offered apply to a product Exchange. The Exchange also offers is not necessary or appropriate in exclusively listed on the Exchange. many other volume-based incentives in furtherance of the purposes of the Act C. Self-Regulatory Organization’s the Fees Schedule.19 because the proposed MRUT Finally, the Exchange believes it is transactions fee and surcharge amounts Statement on Comments on the equitable and not unfairly for each separate type of market Proposed Rule Change Received From discriminatory to offer the financial participant will be assessed Members, Participants, or Others automatically and uniformly to all such The Exchange has not solicited, and 17 See Cboe Options Fees Schedule, ‘‘MSCI LMM market participants, i.e., all qualifying does not intend to solicit, comments on Incentive Program’’, ‘‘GTH VIX/VIXW LMM Customer orders in MRUT will be this proposed rule change. The Incentive Program’’, ‘‘GTH SPX/SPXW LMM assessed the same amount, all Market- Incentive Program’’, and ‘‘RTH SPESG LMM Exchange has not received any written Incentive Program’’. Maker orders in MRUT will be assessed comments from members or other 18 See id. the same amount, and so on. Likewise, interested parties. 19 See e.g., Cboe Options Fees Schedule, Volume the proposed rule change will uniformly Incentive Program table, Liquidity Provider Sliding exclude all transactions in MRUT from III. Date of Effectiveness of the Scale table, Cboe Options Clearing Trading Permit certain programs and fees/surcharges Proposed Rule Change and Timing for Holder Proprietary Products Sliding Scale table, Commission Action and Floor Broker ADV Discount table, each of (i.e., the AIM Contra Fee and Complex which offers reduced transaction fees for meeting The foregoing rule change has become various levels of options volume. 20 See supra note 17. effective pursuant to Section 19(b)(3)(A)

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of the Act 21 and paragraph (f) of Rule inspection and copying at the principal investable funds of the Government 19b–4 22 thereunder. At any time within office of the Exchange. All comments Securities Division of FICC (‘‘GSD’’), as 60 days of the filing of the proposed rule received will be posted without change. described in greater detail below. change, the Commission summarily may Persons submitting comments are II. Clearing Agency’s Statement of the temporarily suspend such rule change if cautioned that we do not redact or edit Purpose of, and Statutory Basis for, the it appears to the Commission that such personal identifying information from action is necessary or appropriate in the comment submissions. You should Proposed Rule Change public interest, for the protection of submit only information that you wish In its filing with the Commission, the investors, or otherwise in furtherance of to make available publicly. All clearing agency included statements the purposes of the Act. If the submissions should refer to File concerning the purpose of and basis for Commission takes such action, the Number SR–CBOE–2021–015 and the proposed rule change and discussed Commission will institute proceedings should be submitted on or before April any comments it received on the to determine whether the proposed rule 6, 2021. proposed rule change. The text of these change should be approved or For the Commission, by the Division of statements may be examined at the disapproved. Trading and Markets, pursuant to delegated places specified in Item IV below. The authority.23 clearing agency has prepared IV. Solicitation of Comments J. Matthew DeLesDernier, summaries, set forth in sections A, B, Interested persons are invited to Assistant Secretary. and C below, of the most significant submit written data, views and [FR Doc. 2021–05348 Filed 3–15–21; 8:45 am] aspects of such statements. arguments concerning the foregoing, including whether the proposed rule BILLING CODE 8011–01–P (A) Clearing Agency’s Statement of the change is consistent with the Act. Purpose of, and Statutory Basis for, the Proposed Rule Change Comments may be submitted by any of SECURITIES AND EXCHANGE the following methods: COMMISSION 1. Purpose Electronic Comments [Release No. 34–91291; File No. SR–DTC– The Clearing Agencies are proposing • Use the Commission’s internet 2021–002] to revise the Investment Policy, which comment form (http://www.sec.gov/ was adopted for each clearing agency in rules/sro.shtml); or Self-Regulatory Organizations; The December 2016 3 and is maintained in • Send an email to rule-comments@ Depository Trust Company; Notice of compliance with Rule 17Ad–22(e)(16) sec.gov. Please include File Number SR– Filing of a Proposed Rule Change To under the Act,4 in order to (1) enhance CBOE–2021–015 on the subject line. Revise the Clearing Agency the methodology for determining Investment Policy investment limits for investments in Paper Comments March 10, 2021. bank deposits, and (2) clarify the • Send paper comments in triplicate Pursuant to Section 19(b)(1) of the description of certain investable funds to Secretary, Securities and Exchange Securities Exchange Act of 1934 of GSD, as described in greater detail Commission, 100 F Street NE, (‘‘Act’’) 1 and Rule 19b–4 thereunder,2 below. Washington, DC 20549–1090. notice is hereby given that on March 8, Overview of the Investment Policy All submissions should refer to File 2021, The Depository Trust Company Number SR–CBOE–2021–015. This file (‘‘DTC’’) filed with the Securities and The Investment Policy governs the number should be included on the Exchange Commission (‘‘Commission’’) management, custody and investment of subject line if email is used. To help the the proposed rule change as described cash deposited to the respective NSCC Commission process and review your in Items I, II and III below, which Items and FICC Clearing Funds, and the DTC 5 comments more efficiently, please use have been prepared by the clearing Participants Fund, the proprietary only one method. The Commission will agency. The Commission is publishing liquid net assets (cash and cash post all comments on the Commission’s this notice to solicit comments on the equivalents) of the Clearing Agencies, internet website (http://www.sec.gov/ proposed rule change from interested and other funds held by the Clearing rules/sro.shtml). Copies of the persons. Agencies pursuant to their respective submission, all subsequent rules. amendments, all written statements I. Clearing Agency’s Statement of the with respect to the proposed rule Terms of Substance of the Proposed 3 See Securities Exchange Act Release No. 79528 change that are filed with the Rule Change (December 12, 2016), 81 FR 91232 (December 16, Commission, and all written 2016) (SR–DTC–2016–007, SR–FICC–2016–005, The proposed rule change would SR–NSCC–2016–003). communications relating to the revise the Clearing Agency Investment 4 17 CFR 240.17Ad–22(e)(16). As discussed in proposed rule change between the Policy (‘‘Investment Policy’’) of The this filing, the Investment Policy also addresses Commission and any person, other than Depository Trust Company (‘‘DTC’’) and compliance with the requirements of Rule 17Ad– those that may be withheld from the its affiliates, National Securities 22(e)(3). 17 CFR 240.17Ad–22(e)(3). public in accordance with the 5 The respective Clearing Funds of NSCC and Clearing Corporation (‘‘NSCC’’) and FICC, and the DTC Participants Fund are described provisions of 5 U.S.C. 552, will be Fixed Income Clearing Corporation further in the Rules & Procedures of NSCC (‘‘NSCC available for website viewing and (‘‘FICC,’’ and together with DTC and Rules’’), the DTC Rules, By-laws and Organization printing in the Commission’s Public NSCC, the ‘‘Clearing Agencies’’) in order Certificate (‘‘DTC Rules’’), the Clearing Rules of the Reference Room, 100 F Street NE, Mortgage-Backed Securities Division of FICC to (1) enhance the methodology for (‘‘MBSD Rules’’) or the Rulebook of the Government Washington, DC 20549, on official determining investment limits for Securities Division of FICC (‘‘GSD Rules’’), business days between the hours of investments in bank deposits, and (2) respectively, available at http://dtcc.com/legal/ 10:00 a.m. and 3:00 p.m. Copies of the clarify the description of certain rules-and-procedures. See Rule 4 (Clearing Fund) of filing also will be available for the NSCC Rules, Rule 4 (Participants Fund and Participants Investment) of the DTC Rules, Rule 4 23 17 CFR 200.30–3(a)(12). (Clearing Fund and Loss Allocation) of the GSD 21 15 U.S.C. 78s(b)(3)(A). 1 15 U.S.C. 78s(b)(1). Rules and Rule 4 (Clearing Fund and Loss 22 17 CFR 240.19b–4(f). 2 17 CFR 240.19b–4. Allocation) of the MBSD Rules.

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The Investment Policy identifies the Proposed Enhancement to the Formula GSD Rules to refer to these funds.8 The guiding principles for investments and for Setting Bank Deposit Investment proposed change to clarify the term defines the roles and responsibilities of Limits used to describe these funds would DTCC staff in administering the Section 6.2.1 of the Investment Policy prevent any confusion about which Investment Policy pursuant to those sets forth the investment limits funds are included in Section 5 and principles. The Investment Policy is co- applicable to bank deposit investments. invested pursuant to the Policy. owned by DTCC’s Treasury group Currently, bank deposit investment 2. Statutory Basis (‘‘Treasury’’) 6 and the Counterparty limits are determined based on the bank The Clearing Agencies believe that the Credit Risk team (‘‘CCR’’) within counterparty’s external credit rating. For proposed rule changes are consistent DTCC’s Group Chief Risk Office example, investments in a bank deposits with the requirements of the Act and the 7 with a bank counterparty with an (‘‘GCRO’’). Treasury is responsible for rules and regulations thereunder external credit rating of AAA or Aaa are identifying potential counterparties to applicable to a registered clearing limited to no more than $750 million, investment transactions, establishing agency. In particular, the Clearing and an investment with a bank and managing investment relationships Agencies believe that the proposed counterparty with an external credit with approved investment modifications to the Investment Policy rating of BBB+ or Baa1 are limited to no counterparties, and making and are consistent with Section 17A(b)(3)(F) more than $100 million. monitoring all investment transactions of the Act 9 and Rule 17Ad–22(e)(16) The Clearing Agencies are proposing with respect to the Clearing Agencies. under the Act,10 for the reasons to enhance the methodology for setting CCR is responsible for conducting a described below. credit review of any potential investment limits and investment caps Section 17A(b)(3)(F) of the Act counterparty, updating those reviews on on bank deposits with a particular requires, in part, that the rules of each counterparty by including a a quarterly basis, and establishing an of the Clearing Agencies be designed to consideration of the size of the bank investment limit for each counterparty. assure the safeguarding of securities and counterparty, measured as the total funds that are in the custody or control CCR is also responsible for ongoing shareholders’ equity capital, in this monitoring of counterparties and of each of the Clearing Agencies or for calculation. Under the proposed which they are responsible.11 The recommending changes to investment methodology, an investment limit for a limits when appropriate. investment guidelines and governance bank deposit counterparty would procedures set forth in the Investment The Investment Policy also identifies continue to be based on the Policy are designed to safeguard funds sources of funds that may be invested, counterparty’s credit rating, but would that are in the custody or control of the and the permitted investments of those be the lower of (1) a percentage of its Clearing Agencies or for which they are funds, including the authority required total shareholders’ equity capital, and responsible. Such protections include, to make such investments and the (2) the applicable dollar value that is for example, following a prudent and parameters of, and limitations on, each currently in Section 6.2.1 of the conservative investment philosophy type of investment. Allowable Investment Policy. For example, that places the highest priority on investments include bank deposits, investments in a bank deposits with a maximizing liquidity and risk reverse repurchase agreements, direct bank counterparty with an external avoidance. The Clearing Agencies obligations of the U.S. government, credit rating of AAA or Aaa and total believe the proposed change to consider money market mutual funds, high-grade shareholders’ equity capital of $9 billion the size of a bank counterparty in setting would be limited to no more than $750 corporate debt, and hedge transactions. its bank deposit investment limits million, however, investments with a Finally, the Investment Policy defines would allow it to adhere to these bank counterparty with the same the approval authority required to guidelines by minimizing the risk posed external credit rating and total exceed established investment limits. by smaller counterparties, measured by shareholders’ equity capital of $2 billion their shareholders’ equity capital. The Investment Policy is reviewed would be limited to no more than $300 Therefore, the Clearing Agencies believe and approved by the Boards annually. million. the proposed change would allow the In connection with a recent annual The proposed approach would permit Clearing Agencies to continue to operate the Clearing Agencies to take into review of the Investment Policy, the the Investment Policy pursuant to a account the size of a counterparty in Clearing Agencies have decided to prudent and conservative investment setting investment limits rather than propose revisions to the Investment philosophy that assures the apply the same investment limits to Policy in order to (1) enhance the safeguarding of securities and funds that each counterparty with the same credit methodology for determining are in their custody and control, or for rating without regard to the entity’s size. investment limits for investments in which they are responsible. bank deposits, and (2) clarify the The proposal is designed to mitigate the Additionally, the proposed change to description of certain investable funds Clearing Agencies’ risk exposure to align the description of investable funds of GSD, as described in greater detail smaller bank counterparties. of GSD with the description of these below. Proposed Revisions to the Description of funds in the GSD Rules would clarify Investable Funds of GSD the funds that are subject to the Policy and, thereby, improve the effectiveness The Clearing Agencies are also of the Investment Policy and allow the 6 Treasury is a part of the DTCC Finance proposing to amend Section 5 of the Investment Policy to continue to be Department and is responsible for the safeguarding, Investment Policy to revise the administered in alignment with the investment and disbursement of funds on behalf of description of investable funds of GSD, the Clearing Agencies and in accordance with the which are currently described as ‘‘GSD principles outlined in the Investment Policy. 8 See Rule 1 (Definitions) of the GSD Rules. Supra 7 Among other responsibilities, GCRO is generally Forward Margin.’’ The proposed note 5. responsible for the systems and processes designed changes would refer to these funds as 9 15 U.S.C. 78q–1(b)(3)(F). to identify and manage credit, market and liquidity ‘‘GSD Forward Mark Adjustment 10 17 CFR 240.17Ad–22(e)(16). risks to the Clearing Agencies. Payment,’’ which is the term used in the 11 15 U.S.C. 78q–1(b)(3)(F).

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investment guidelines and governance impact, or impose any burden, on subject line if email is used. To help the procedures set forth therein. Given that competition. The Investment Policy Commission process and review your such guidelines and governance applies equally to allowable comments more efficiently, please use procedures are designed to safeguard investments of Clearing Fund and only one method. The Commission will funds that are in the custody or control Participants Fund deposits, as post all comments on the Commission’s of the Clearing Agencies or for which applicable, of each member of the internet website (http://www.sec.gov/ they are responsible, the Clearing Clearing Agencies, and establishes a rules/sro.shtml). Copies of the Agencies believe the proposed changes uniform policy at the Clearing Agencies. submission, all subsequent are consistent with the requirements of The proposed changes to the Investment amendments, all written statements Section 17A(b)(3)(F) of the Act.12 Policy would not affect any changes on with respect to the proposed rule Rule 17Ad–22(e)(16) under the Act the fundamental purpose or operation of change that are filed with the requires the Clearing Agencies to this document and, as such, would also Commission, and all written establish, implement, maintain and not have any impact, or impose any communications relating to the enforce written policies and procedures burden, on competition. proposed rule change between the reasonably designed to safeguard the Commission and any person, other than (C) Clearing Agency’s Statement on Clearing Agencies’ own and their those that may be withheld from the Comments on the Proposed Rule participants’ assets, minimize the risk of public in accordance with the Change Received From Members, loss and delay in access to these assets, provisions of 5 U.S.C. 552, will be Participants, or Others and invest such assets in instruments available for website viewing and with minimal credit, market, and The Clearing Agencies have not printing in the Commission’s Public liquidity risks.13 The Clearing Agencies solicited or received any written Reference Room, 100 F Street NE, believe that the Investment Policy comments relating to this proposal. The Washington, DC 20549 on official follows a prudent and conservative Clearing Agencies will notify the business days between the hours of investment philosophy, placing the Commission of any written comments 10:00 a.m. and 3:00 p.m. Copies of the highest priority on maximizing liquidity received by the Clearing Agencies. filing also will be available for and avoiding risk of loss, by setting III. Date of Effectiveness of the inspection and copying at the principal appropriate investment limits and Proposed Rule Change, and Timing for office of DTC and on DTCC’s website creating clear guidelines. As originally Commission Action (http://dtcc.com/legal/sec-rule- implemented, the Investment Policy filings.aspx). All comments received was designed to meet the requirements Within 45 days of the date of will be posted without change. Persons of Rule 17Ad–22(e)(16) under the Act.14 publication of this notice in the Federal submitting comments are cautioned that For the reasons stated above, the Register or within such longer period we do not redact or edit personal Clearing Agencies believe that the up to 90 days (i) as the Commission may identifying information from comment proposed revisions would both designate if it finds such longer period submissions. You should submit only strengthen the risk management to be appropriate and publishes its information that you wish to make objectives of the Investment Policy and reasons for so finding or (ii) as to which available publicly. All submissions improve the clarity of the Policy and, the self-regulatory organization should refer to File Number SR–DTC– therefore, make the Investment Policy consents, the Commission will: 2021–002 and should be submitted on more effective in governing the (A) By order approve or disapprove or before April 6, 2021. management, custody, and investment such proposed rule change, or For the Commission, by the Division of of funds of and held by the Clearing (B) institute proceedings to determine whether the proposed rule change Trading and Markets, pursuant to delegated Agencies. In this way, the proposed authority.16 should be disapproved. changes would better allow the Clearing J. Matthew DeLesDernier, Agencies to maintain this document in IV. Solicitation of Comments Assistant Secretary. a way that is designed to meet the requirements of Rule 17Ad–22(e)(16). Interested persons are invited to [FR Doc. 2021–05344 Filed 3–15–21; 8:45 am] Therefore, the Clearing Agencies believe submit written data, views and BILLING CODE 8011–01–P the proposed revisions would be arguments concerning the foregoing, including whether the proposed rule consistent with the requirements of Rule SECURITIES AND EXCHANGE 17Ad–22(e)(16) under the Act.15 change is consistent with the Act. Comments may be submitted by any of COMMISSION (B) Clearing Agency’s Statement on the following methods: [SEC File No. 270–574, OMB Control No. Burden on Competition Electronic Comments 3235–0648] Each of the Clearing Agencies believes • that none of the proposed revisions to Use the Commission’s internet Submission for OMB Review; the Investment Policy would have any comment form (http://www.sec.gov/ Comment Request rules/sro.shtml); or Upon Written Request, Copies Available 12 • Send an email to rule-comments@ Id. From: Securities and Exchange 13 sec.gov. Please include File Number SR– When the Investment Policy was implemented, Commission, Office of FOIA Services, the Clearing Agencies were subject to the DTC–2021–002 on the subject line. requirements of subsection (d) of Rule 17Ad–22 and 100 F Street NE, Washington, DC the Investment Policy was designed to meet the Paper Comments 20549–2736 requirements of Rule 17Ad–22(d)(3). See supra note • 3; 17 CFR 240.17Ad–22(d). The Commission Send paper comments in triplicate Extension: subsequently adopted Rule 17Ad–22(e) and to Secretary, Securities and Exchange Rule 498 amended Rule 17Ad–22(d) such that the Clearing Commission, 100 F Street NE, Notice is hereby given that, pursuant Agencies became subject to the new requirements Washington, DC 20549. of Rule 17Ad–22(e) and are no longer subject to the to the Paperwork Reduction Act of 1995 requirements of Rule 17Ad–22(d). Id. All submissions should refer to File (44 U.S.C. 3501 et seq.) (‘‘Paperwork 14 17 CFR 240.17Ad–22(e)(16). Number SR–DTC–2021–002. This file 15 Id. number should be included on the 16 17 CFR 200.30–3(a)(12).

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Reduction Act’’), the Securities and of 1.5 hours per fund per year.1 Thus the SECURITIES AND EXCHANGE Exchange Commission (‘‘the total annual hour burden associated COMMISSION Commission’’) has submitted to the with these requirements of the rule is Office of Management and Budget approximately 15,804.2 The [Release No. 34–91292; File No. SR–FICC– (‘‘OMB’’) a request for extension of the Commission estimates that the annual 2021–001] previously approved collection of cost burden is approximately $18,105 information discussed below. per fund, for a total annual cost burden Self-Regulatory Organizations; Fixed Rule 498 (17 CFR 230.498) under the of approximately $190,754,280.3 Income Clearing Corporation; Notice of Securities Act of 1933 (15 U.S.C. 77a et Estimates of the average burden hours Filing of a Proposed Rule Change To seq.) (‘‘Securities Act’’) permits open- are made solely for the purposes of the Revise the Clearing Agency end management investment companies Paperwork Reduction Act and are not Investment Policy (‘‘funds’’) to satisfy their prospectus derived from a comprehensive or even March 10, 2021. delivery obligations under the Securities a representative survey or study of the Act by sending or giving key costs of Commission rules and forms. Pursuant to Section 19(b)(1) of the information directly to investors in the Under rule 498, use of the Summary Securities Exchange Act of 1934 form of a summary prospectus 1 2 Prospectus is voluntary, but the rule’s (‘‘Act’’) and Rule 19b–4 thereunder, (‘‘Summary Prospectus’’) and providing requirements regarding provision of the notice is hereby given that on March 8, the statutory prospectus on a website. 2021, Fixed Income Clearing Upon an investor’s request, funds are statutory prospectus upon investor request are mandatory for funds that Corporation (‘‘FICC’’) filed with the also required to send the statutory Securities and Exchange Commission prospectus to the investor. In addition, elect to send or give a Summary Prospectus in reliance upon rule 498. (‘‘Commission’’) the proposed rule under rule 498, a fund that relies on the change as described in Items I, II and III rule to meet its statutory prospectus The information provided under rule 498 will not be kept confidential. An below, which Items have been prepared delivery obligations must make by the clearing agency. The Commission agency may not conduct or sponsor, and available, free of charge, the fund’s is publishing this notice to solicit a person is not required to respond to, current Summary Prospectus, statutory comments on the proposed rule change prospectus, statement of additional a collection of information unless it from interested persons. information, and most recent annual displays a currently valid OMB control and semi-annual reports to shareholders number. I. Clearing Agency’s Statement of the at the website address specified in the The public may view background Terms of Substance of the Proposed required Summary Prospectus legend documentation for this information Rule Change (17 CFR 270.498(e)(1)). A Summary collection at the following website: Prospectus that complies with rule 498 The proposed rule change would www.reginfo.gov. Find this particular is deemed to be a prospectus that is revise the Clearing Agency Investment information collection by selecting authorized under Section 10(b) of the Policy (‘‘Investment Policy’’) of Fixed ‘‘Currently under 30-day Review—Open Securities Act and Section 24(g) of the Income Clearing Corporation (‘‘FICC’’) Investment Company Act of 1940 (15 for Public Comments’’ or by using the and its affiliates, The Depository Trust U.S.C. 80a–1 et seq.). search function. Written comments and Company (‘‘DTC’’) and National recommendations for the proposed The purpose of rule 498 is to enable Securities Clearing Corporation information collection should be sent (‘‘NSCC,’’ and, together with DTC and a fund to provide investors with a within 30 days of publication of this Summary Prospectus containing key FICC, the ‘‘Clearing Agencies’’) in order notice to (i) www.reginfo.gov/public/do/ information necessary to evaluate an to (1) enhance the methodology for PRAMain and (ii) David Bottom, investment in the fund. Unlike many determining investment limits for Director/Chief Information Officer, other federal information collections, investments in bank deposits, and (2) which are primarily for the use and Securities and Exchange Commission, clarify the description of certain benefit of the collecting agency, this c/o Cynthia Roscoe, 100 F Street NE, investable funds of the Government information collection is primarily for Washington, DC 20549, or by sending an Securities Division of FICC (‘‘GSD’’), as _ the use and benefit of investors. The email to: PRA [email protected]. described in greater detail below. information filed with the Commission Dated: March 11, 2021. II. Clearing Agency’s Statement of the also permits the verification of J. Matthew DeLesDernier, Purpose of, and Statutory Basis for, the compliance with securities law Assistant Secretary. requirements and assures the public Proposed Rule Change [FR Doc. 2021–05376 Filed 3–15–21; 8:45 am] availability and dissemination of the In its filing with the Commission, the BILLING CODE 8011–01–P information. clearing agency included statements Based on an analysis of fund filings, concerning the purpose of and basis for the Commission estimates that the proposed rule change and discussed approximately 10,536 funds are using a any comments it received on the Summary Prospectus. The Commission proposed rule change. The text of these estimates that the annual hourly burden statements may be examined at the per fund associated with the places specified in Item IV below. The compilation of the information required clearing agency has prepared on the cover page or the beginning of summaries, set forth in sections A, B, the Summary Prospectus is 0.5 hours, 1 0.5 hours per fund + 1 hour per fund = 1.5 hours and C below, of the most significant and estimates that the annual hourly per fund. aspects of such statements. burden per fund to comply with the 2 1.5 hours per fund × 10,536 fund = 15,804 website posting requirement is hours. 1 15 U.S.C. 78s(b)(1). approximately 1 hour, requiring a total 3 $18,105 per fund × 10,536 fund = $190,754,280. 2 17 CFR 240.19b–4.

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(A) Clearing Agency’s Statement of the and managing investment relationships methodology, an investment limit for a Purpose of, and Statutory Basis for, the with approved investment bank deposit counterparty would Proposed Rule Change counterparties, and making and continue to be based on the monitoring all investment transactions counterparty’s credit rating, but would 1. Purpose with respect to the Clearing Agencies. be the lower of (1) a percentage of its The Clearing Agencies are proposing CCR is responsible for conducting a total shareholders’ equity capital, and to revise the Investment Policy, which credit review of any potential (2) the applicable dollar value that is was adopted for each clearing agency in counterparty, updating those reviews on currently in Section 6.2.1 of the December 2016 3 and is maintained in a quarterly basis, and establishing an Investment Policy. For example, compliance with Rule 17Ad–22(e)(16) investment limit for each counterparty. investments in a bank deposits with a under the Act,4 in order to (1) enhance CCR is also responsible for ongoing bank counterparty with an external the methodology for determining monitoring of counterparties and credit rating of AAA or Aaa and total investment limits for investments in recommending changes to investment shareholders’ equity capital of $9 billion bank deposits, and (2) clarify the limits when appropriate. would be limited to no more than $750 description of certain investable funds The Investment Policy also identifies million, however, investments with a of GSD, as described in greater detail sources of funds that may be invested, bank counterparty with the same below. and the permitted investments of those external credit rating and total Overview of the Investment Policy funds, including the authority required shareholders’ equity capital of $2 billion to make such investments and the would be limited to no more than $300 The Investment Policy governs the parameters of, and limitations on, each million. management, custody and investment of type of investment. Allowable The proposed approach would permit cash deposited to the respective NSCC investments include bank deposits, the Clearing Agencies to take into and FICC Clearing Funds, and the DTC reverse repurchase agreements, direct account the size of a counterparty in Participants Fund,5 the proprietary obligations of the U.S. government, setting investment limits rather than liquid net assets (cash and cash money market mutual funds, high-grade apply the same investment limits to equivalents) of the Clearing Agencies, corporate debt, and hedge transactions. each counterparty with the same credit and other funds held by the Clearing Finally, the Investment Policy defines Agencies pursuant to their respective rating without regard to the entity’s size. the approval authority required to The proposal is designed to mitigate the rules. exceed established investment limits. The Investment Policy identifies the Clearing Agencies’ risk exposure to The Investment Policy is reviewed smaller bank counterparties. guiding principles for investments and and approved by the Boards annually. defines the roles and responsibilities of In connection with a recent annual Proposed Revisions to the Description of DTCC staff in administering the review of the Investment Policy, the Investable Funds of GSD Investment Policy pursuant to those Clearing Agencies have decided to The Clearing Agencies are also principles. The Investment Policy is co- propose revisions to the Investment owned by DTCC’s Treasury group proposing to amend Section 5 of the Policy in order to (1) enhance the Investment Policy to revise the (‘‘Treasury’’) 6 and the Counterparty methodology for determining Credit Risk team (‘‘CCR’’) within description of investable funds of GSD, investment limits for investments in which are currently described as ‘‘GSD DTCC’s Group Chief Risk Office bank deposits, and (2) clarify the (‘‘GCRO’’).7 Treasury is responsible for Forward Margin.’’ The proposed description of certain investable funds changes would refer to these funds as identifying potential counterparties to of GSD, as described in greater detail investment transactions, establishing ‘‘GSD Forward Mark Adjustment below. Payment,’’ which is the term used in the 8 3 See Securities Exchange Act Release No. 79528 Proposed Enhancement to the Formula GSD Rules to refer to these funds. The (December 12, 2016), 81 FR 91232 (December 16, for Setting Bank Deposit Investment proposed change to clarify the term 2016) (SR–DTC–2016–007, SR–FICC–2016–005, Limits used to describe these funds would SR–NSCC–2016–003). prevent any confusion about which 4 Section 6.2.1 of the Investment Policy 17 CFR 240.17Ad–22(e)(16). As discussed in funds are included in Section 5 and this filing, the Investment Policy also addresses sets forth the investment limits invested pursuant to the Policy. compliance with the requirements of Rule 17Ad– applicable to bank deposit investments. 22(e)(3). 17 CFR 240.17Ad–22(e)(3). 5 The respective Clearing Funds of NSCC and Currently, bank deposit investment 2. Statutory Basis FICC, and the DTC Participants Fund are described limits are determined based on the bank The Clearing Agencies believe that the further in the Rules & Procedures of NSCC (‘‘NSCC counterparty’s external credit rating. For proposed rule changes are consistent Rules’’), the DTC Rules, By-laws and Organization example, investments in a bank deposits Certificate (‘‘DTC Rules’’), the Clearing Rules of the with the requirements of the Act and the Mortgage-Backed Securities Division of FICC with a bank counterparty with an rules and regulations thereunder (‘‘MBSD Rules’’) or the Rulebook of the Government external credit rating of AAA or Aaa are applicable to a registered clearing Securities Division of FICC (‘‘GSD Rules’’), limited to no more than $750 million, agency. In particular, the Clearing respectively, available at http://dtcc.com/legal/ and an investment with a bank rules-and-procedures. See Rule 4 (Clearing Fund) of Agencies believe that the proposed the NSCC Rules, Rule 4 (Participants Fund and counterparty with an external credit modifications to the Investment Policy Participants Investment) of the DTC Rules, Rule 4 rating of BBB+ or Baa1 are limited to no are consistent with Section 17A(b)(3)(F) (Clearing Fund and Loss Allocation) of the GSD more than $100 million. of the Act 9 and Rule 17Ad–22(e)(16) Rules and Rule 4 (Clearing Fund and Loss The Clearing Agencies are proposing under the Act,10 for the reasons Allocation) of the MBSD Rules. to enhance the methodology for setting 6 Treasury is a part of the DTCC Finance described below. investment limits and investment caps Department and is responsible for the safeguarding, Section 17A(b)(3)(F) of the Act on bank deposits with a particular investment and disbursement of funds on behalf of requires, in part, that the rules of each the Clearing Agencies and in accordance with the counterparty by including a principles outlined in the Investment Policy. consideration of the size of the bank 7 Among other responsibilities, GCRO is generally 8 See Rule 1 (Definitions) of the GSD Rules. Supra responsible for the systems and processes designed counterparty, measured as the total note 5. to identify and manage credit, market and liquidity shareholders’ equity capital, in this 9 15 U.S.C. 78q–1(b)(3)(F). risks to the Clearing Agencies. calculation. Under the proposed 10 17 CFR 240.17Ad–22(e)(16).

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of the Clearing Agencies be designed to believe that the Investment Policy III. Date of Effectiveness of the assure the safeguarding of securities and follows a prudent and conservative Proposed Rule Change, and Timing for funds that are in the custody or control investment philosophy, placing the Commission Action of each of the Clearing Agencies or for highest priority on maximizing liquidity 11 Within 45 days of the date of which they are responsible. The and avoiding risk of loss, by setting publication of this notice in the Federal investment guidelines and governance appropriate investment limits and Register or within such longer period procedures set forth in the Investment creating clear guidelines. As originally up to 90 days (i) as the Commission may Policy are designed to safeguard funds implemented, the Investment Policy designate if it finds such longer period that are in the custody or control of the was designed to meet the requirements to be appropriate and publishes its Clearing Agencies or for which they are 14 of Rule 17Ad–22(e)(16) under the Act. reasons for so finding or (ii) as to which responsible. Such protections include, For the reasons stated above, the the self-regulatory organization for example, following a prudent and Clearing Agencies believe that the consents, the Commission will: conservative investment philosophy proposed revisions would both (A) By order approve or disapprove that places the highest priority on strengthen the risk management such proposed rule change, or maximizing liquidity and risk objectives of the Investment Policy and (B) institute proceedings to determine avoidance. The Clearing Agencies improve the clarity of the Policy and, whether the proposed rule change believe the proposed change to consider therefore, make the Investment Policy should be disapproved. the size of a bank counterparty in setting more effective in governing the its bank deposit investment limits management, custody, and investment IV. Solicitation of Comments would allow it to adhere to these of funds of and held by the Clearing Interested persons are invited to guidelines by minimizing the risk posed Agencies. In this way, the proposed submit written data, views and by smaller counterparties, measured by changes would better allow the Clearing arguments concerning the foregoing, their shareholders’ equity capital. Agencies to maintain this document in including whether the proposed rule Therefore, the Clearing Agencies believe a way that is designed to meet the change is consistent with the Act. the proposed change would allow the requirements of Rule 17Ad–22(e)(16). Comments may be submitted by any of Clearing Agencies to continue to operate Therefore, the Clearing Agencies believe the following methods: the Investment Policy pursuant to a the proposed revisions would be prudent and conservative investment consistent with the requirements of Rule Electronic Comments philosophy that assures the 17Ad–22(e)(16) under the Act.15 • Use the Commission’s internet safeguarding of securities and funds that comment form (http://www.sec.gov/ (B) Clearing Agency’s Statement on are in their custody and control, or for rules/sro.shtml); or which they are responsible. Burden on Competition • Send an email to rule-comments@ Additionally, the proposed change to sec.gov. Please include File Number SR– align the description of investable funds Each of the Clearing Agencies believes FICC–2021–001 on the subject line. of GSD with the description of these that none of the proposed revisions to funds in the GSD Rules would clarify the Investment Policy would have any Paper Comments impact, or impose any burden, on the funds that are subject to the Policy • competition. The Investment Policy Send paper comments in triplicate and, thereby, improve the effectiveness to Secretary, Securities and Exchange of the Investment Policy and allow the applies equally to allowable Commission, 100 F Street NE, Investment Policy to continue to be investments of Clearing Fund and Washington, DC 20549. administered in alignment with the Participants Fund deposits, as investment guidelines and governance applicable, of each member of the All submissions should refer to File procedures set forth therein. Given that Clearing Agencies, and establishes a Number SR–FICC–2021–001. This file such guidelines and governance uniform policy at the Clearing Agencies. number should be included on the procedures are designed to safeguard The proposed changes to the Investment subject line if email is used. To help the funds that are in the custody or control Policy would not affect any changes on Commission process and review your of the Clearing Agencies or for which the fundamental purpose or operation of comments more efficiently, please use they are responsible, the Clearing this document and, as such, would also only one method. The Commission will Agencies believe the proposed changes not have any impact, or impose any post all comments on the Commission’s are consistent with the requirements of burden, on competition. internet website (http://www.sec.gov/ 12 rules/sro.shtml). Copies of the Section 17A(b)(3)(F) of the Act. (C) Clearing Agency’s Statement on submission, all subsequent Rule 17Ad–22(e)(16) under the Act Comments on the Proposed Rule amendments, all written statements requires the Clearing Agencies to Change Received From Members, with respect to the proposed rule establish, implement, maintain and Participants, or Others enforce written policies and procedures change that are filed with the reasonably designed to safeguard the The Clearing Agencies have not Commission, and all written Clearing Agencies’ own and their solicited or received any written communications relating to the participants’ assets, minimize the risk of comments relating to this proposal. The proposed rule change between the loss and delay in access to these assets, Clearing Agencies will notify the Commission and any person, other than and invest such assets in instruments Commission of any written comments those that may be withheld from the with minimal credit, market, and received by the Clearing Agencies. public in accordance with the liquidity risks.13 The Clearing Agencies provisions of 5 U.S.C. 552, will be 3; 17 CFR 240.17Ad–22(d). The Commission available for website viewing and 11 15 U.S.C. 78q–1(b)(3)(F). subsequently adopted Rule 17Ad–22(e) and printing in the Commission’s Public 12 Id. amended Rule 17Ad–22(d) such that the Clearing Reference Room, 100 F Street NE, 13 When the Investment Policy was implemented, Agencies became subject to the new requirements Washington, DC 20549 on official the Clearing Agencies were subject to the of Rule 17Ad–22(e) and are no longer subject to the requirements of subsection (d) of Rule 17Ad–22 and requirements of Rule 17Ad–22(d). Id. business days between the hours of the Investment Policy was designed to meet the 14 17 CFR 240.17Ad–22(e)(16). 10:00 a.m. and 3:00 p.m. Copies of the requirements of Rule 17Ad–22(d)(3). See supra note 15 Id. filing also will be available for

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inspection and copying at the principal clarify the description of certain Agencies pursuant to their respective office of FICC and on DTCC’s website investable funds of the Government rules. (http://dtcc.com/legal/sec-rule- Securities Division of FICC (‘‘GSD’’), as The Investment Policy identifies the filings.aspx). All comments received described in greater detail below. guiding principles for investments and will be posted without change. Persons defines the roles and responsibilities of submitting comments are cautioned that II. Clearing Agency’s Statement of the DTCC staff in administering the we do not redact or edit personal Purpose of, and Statutory Basis for, the identifying information from comment Proposed Rule Change Investment Policy pursuant to those submissions. You should submit only principles. The Investment Policy is co- In its filing with the Commission, the owned by DTCC’s Treasury group information that you wish to make clearing agency included statements available publicly. All submissions (‘‘Treasury’’) 6 and the Counterparty concerning the purpose of and basis for Credit Risk team (‘‘CCR’’) within should refer to File Number SR–FICC– the proposed rule change and discussed 2021–001 and should be submitted on DTCC’s Group Chief Risk Office any comments it received on the (‘‘GCRO’’).7 Treasury is responsible for or before April 6, 2021. proposed rule change. The text of these identifying potential counterparties to For the Commission, by the Division of statements may be examined at the investment transactions, establishing Trading and Markets, pursuant to delegated places specified in Item IV below. The 16 and managing investment relationships authority. clearing agency has prepared J. Matthew DeLesDernier, summaries, set forth in sections A, B, with approved investment Assistant Secretary. and C below, of the most significant counterparties, and making and [FR Doc. 2021–05341 Filed 3–15–21; 8:45 am] aspects of such statements. monitoring all investment transactions BILLING CODE 8011–01–P with respect to the Clearing Agencies. (A) Clearing Agency’s Statement of the CCR is responsible for conducting a Purpose of, and Statutory Basis for, the credit review of any potential SECURITIES AND EXCHANGE Proposed Rule Change counterparty, updating those reviews on COMMISSION 1. Purpose a quarterly basis, and establishing an [Release No. 34–91293; File No. SR–NSCC– investment limit for each counterparty. 2021–003] The Clearing Agencies are proposing CCR is also responsible for ongoing to revise the Investment Policy, which monitoring of counterparties and Self-Regulatory Organizations; was adopted for each clearing agency in recommending changes to investment National Securities Clearing December 2016 3 and is maintained in limits when appropriate. Corporation; Notice of Filing of a compliance with Rule 17Ad–22(e)(16) The Investment Policy also identifies under the Act,4 in order to (1) enhance Proposed Rule Change To Revise the sources of funds that may be invested, Clearing Agency Investment Policy the methodology for determining and the permitted investments of those investment limits for investments in funds, including the authority required March 10, 2021. bank deposits, and (2) clarify the Pursuant to Section 19(b)(1) of the description of certain investable funds to make such investments and the Securities Exchange Act of 1934 of GSD, as described in greater detail parameters of, and limitations on, each 1 2 (‘‘Act’’) and Rule 19b–4 thereunder, below. type of investment. Allowable notice is hereby given that on March 8, investments include bank deposits, 2021, National Securities Clearing Overview of the Investment Policy reverse repurchase agreements, direct Corporation (‘‘NSCC’’) filed with the obligations of the U.S. government, The Investment Policy governs the Securities and Exchange Commission money market mutual funds, high-grade management, custody and investment of (‘‘Commission’’) the proposed rule corporate debt, and hedge transactions. cash deposited to the respective NSCC change as described in Items I, II and III Finally, the Investment Policy defines below, which Items have been prepared and FICC Clearing Funds, and the DTC Participants Fund,5 the proprietary the approval authority required to by the clearing agency. The Commission exceed established investment limits. is publishing this notice to solicit liquid net assets (cash and cash comments on the proposed rule change equivalents) of the Clearing Agencies, The Investment Policy is reviewed from interested persons. and other funds held by the Clearing and approved by the Boards annually. In connection with a recent annual I. Clearing Agency’s Statement of the 3 See Securities Exchange Act Release No. 79528 review of the Investment Policy, the Terms of Substance of the Proposed (December 12, 2016), 81 FR 91232 (December 16, Clearing Agencies have decided to Rule Change 2016) (SR–DTC–2016–007, SR–FICC–2016–005, propose revisions to the Investment SR–NSCC–2016–003). The proposed rule change would 4 17 CFR 240.17Ad–22(e)(16). As discussed in Policy in order to (1) enhance the revise the Clearing Agency Investment this filing, the Investment Policy also addresses methodology for determining Policy (‘‘Investment Policy’’) of National compliance with the requirements of Rule 17Ad– investment limits for investments in Securities Clearing Corporation 22(e)(3). 17 CFR 240.17Ad–22(e)(3). bank deposits, and (2) clarify the 5 The respective Clearing Funds of NSCC and (‘‘NSCC’’) and its affiliates, The FICC, and the DTC Participants Fund are described description of certain investable funds Depository Trust Company (‘‘DTC’’) and further in the Rules & Procedures of NSCC (‘‘NSCC of GSD, as described in greater detail Fixed Income Clearing Corporation Rules’’), the DTC Rules, By-laws and Organization below. (‘‘FICC,’’ and together with DTC and Certificate (‘‘DTC Rules’’), the Clearing Rules of the Mortgage-Backed Securities Division of FICC NSCC, the ‘‘Clearing Agencies’’) in order (‘‘MBSD Rules’’) or the Rulebook of the Government 6 Treasury is a part of the DTCC Finance to (1) enhance the methodology for Securities Division of FICC (‘‘GSD Rules’’), Department and is responsible for the safeguarding, determining investment limits for respectively, available at http://dtcc.com/legal/ investment and disbursement of funds on behalf of investments in bank deposits, and (2) rules-and-procedures. See Rule 4 (Clearing Fund) of the Clearing Agencies and in accordance with the the NSCC Rules, Rule 4 (Participants Fund and principles outlined in the Investment Policy. Participants Investment) of the DTC Rules, Rule 4 7 Among other responsibilities, GCRO is generally 16 17 CFR 200.30–3(a)(12). (Clearing Fund and Loss Allocation) of the GSD responsible for the systems and processes designed 1 15 U.S.C. 78s(b)(1). Rules and Rule 4 (Clearing Fund and Loss to identify and manage credit, market and liquidity 2 17 CFR 240.19b–4. Allocation) of the MBSD Rules. risks to the Clearing Agencies.

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Proposed Enhancement to the Formula GSD Rules to refer to these funds.8 The investment guidelines and governance for Setting Bank Deposit Investment proposed change to clarify the term procedures set forth therein. Given that Limits used to describe these funds would such guidelines and governance Section 6.2.1 of the Investment Policy prevent any confusion about which procedures are designed to safeguard sets forth the investment limits funds are included in Section 5 and funds that are in the custody or control applicable to bank deposit investments. invested pursuant to the Policy. of the Clearing Agencies or for which they are responsible, the Clearing Currently, bank deposit investment 2. Statutory Basis limits are determined based on the bank Agencies believe the proposed changes The Clearing Agencies believe that the are consistent with the requirements of counterparty’s external credit rating. For proposed rule changes are consistent Section 17A(b)(3)(F) of the Act.12 example, investments in a bank deposits with the requirements of the Act and the Rule 17Ad–22(e)(16) under the Act with a bank counterparty with an rules and regulations thereunder requires the Clearing Agencies to external credit rating of AAA or Aaa are applicable to a registered clearing establish, implement, maintain and limited to no more than $750 million, agency. In particular, the Clearing enforce written policies and procedures and an investment with a bank Agencies believe that the proposed reasonably designed to safeguard the counterparty with an external credit modifications to the Investment Policy Clearing Agencies’ own and their rating of BBB+ or Baa1 are limited to no are consistent with Section 17A(b)(3)(F) participants’ assets, minimize the risk of more than $100 million. of the Act 9 and Rule 17Ad–22(e)(16) loss and delay in access to these assets, The Clearing Agencies are proposing under the Act,10 for the reasons and invest such assets in instruments to enhance the methodology for setting described below. with minimal credit, market, and investment limits and investment caps Section 17A(b)(3)(F) of the Act liquidity risks.13 The Clearing Agencies on bank deposits with a particular requires, in part, that the rules of each believe that the Investment Policy counterparty by including a of the Clearing Agencies be designed to follows a prudent and conservative consideration of the size of the bank assure the safeguarding of securities and investment philosophy, placing the counterparty, measured as the total funds that are in the custody or control highest priority on maximizing liquidity shareholders’ equity capital, in this of each of the Clearing Agencies or for and avoiding risk of loss, by setting calculation. Under the proposed which they are responsible.11 The appropriate investment limits and methodology, an investment limit for a investment guidelines and governance creating clear guidelines. As originally bank deposit counterparty would procedures set forth in the Investment implemented, the Investment Policy continue to be based on the Policy are designed to safeguard funds was designed to meet the requirements counterparty’s credit rating, but would that are in the custody or control of the of Rule 17Ad–22(e)(16) under the Act.14 be the lower of (1) a percentage of its Clearing Agencies or for which they are For the reasons stated above, the total shareholders’ equity capital, and responsible. Such protections include, Clearing Agencies believe that the (2) the applicable dollar value that is for example, following a prudent and proposed revisions would both currently in Section 6.2.1 of the conservative investment philosophy strengthen the risk management Investment Policy. For example, that places the highest priority on objectives of the Investment Policy and investments in a bank deposits with a maximizing liquidity and risk improve the clarity of the Policy and, bank counterparty with an external avoidance. The Clearing Agencies therefore, make the Investment Policy credit rating of AAA or Aaa and total believe the proposed change to consider more effective in governing the shareholders’ equity capital of $9 billion the size of a bank counterparty in setting management, custody, and investment would be limited to no more than $750 its bank deposit investment limits of funds of and held by the Clearing million, however, investments with a would allow it to adhere to these Agencies. In this way, the proposed bank counterparty with the same guidelines by minimizing the risk posed changes would better allow the Clearing external credit rating and total by smaller counterparties, measured by Agencies to maintain this document in shareholders’ equity capital of $2 billion their shareholders’ equity capital. a way that is designed to meet the would be limited to no more than $300 Therefore, the Clearing Agencies believe requirements of Rule 17Ad–22(e)(16). million. the proposed change would allow the Therefore, the Clearing Agencies believe The proposed approach would permit Clearing Agencies to continue to operate the proposed revisions would be the Clearing Agencies to take into the Investment Policy pursuant to a consistent with the requirements of Rule account the size of a counterparty in prudent and conservative investment 17Ad–22(e)(16) under the Act.15 setting investment limits rather than philosophy that assures the apply the same investment limits to (B) Clearing Agency’s Statement on safeguarding of securities and funds that each counterparty with the same credit Burden on Competition are in their custody and control, or for rating without regard to the entity’s size. which they are responsible. Each of the Clearing Agencies believes The proposal is designed to mitigate the Additionally, the proposed change to that none of the proposed revisions to Clearing Agencies’ risk exposure to align the description of investable funds the Investment Policy would have any smaller bank counterparties. of GSD with the description of these Proposed Revisions to the Description of funds in the GSD Rules would clarify 12 Id. the funds that are subject to the Policy 13 When the Investment Policy was implemented, Investable Funds of GSD the Clearing Agencies were subject to the The Clearing Agencies are also and, thereby, improve the effectiveness requirements of subsection (d) of Rule 17Ad–22 and of the Investment Policy and allow the the Investment Policy was designed to meet the proposing to amend Section 5 of the requirements of Rule 17Ad–22(d)(3). See supra note Investment Policy to revise the Investment Policy to continue to be administered in alignment with the 3; 17 CFR 240.17Ad–22(d). The Commission description of investable funds of GSD, subsequently adopted Rule 17Ad–22(e) and which are currently described as ‘‘GSD amended Rule 17Ad–22(d) such that the Clearing 8 See Rule 1 (Definitions) of the GSD Rules. Supra Agencies became subject to the new requirements Forward Margin.’’ The proposed note 5. of Rule 17Ad–22(e) and are no longer subject to the changes would refer to these funds as 9 15 U.S.C. 78q–1(b)(3)(F). requirements of Rule 17Ad–22(d). Id. ‘‘GSD Forward Mark Adjustment 10 17 CFR 240.17Ad–22(e)(16). 14 17 CFR 240.17Ad–22(e)(16). Payment,’’ which is the term used in the 11 15 U.S.C. 78q–1(b)(3)(F). 15 Id.

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impact, or impose any burden, on subject line if email is used. To help the ‘‘Exchange’’) filed with the Securities competition. The Investment Policy Commission process and review your and Exchange Commission applies equally to allowable comments more efficiently, please use (‘‘Commission’’), pursuant to Section investments of Clearing Fund and only one method. The Commission will 19(b)(1) of the Securities Exchange Act Participants Fund deposits, as post all comments on the Commission’s of 1934 (‘‘Act’’) 1 and Rule 19b–4 applicable, of each member of the internet website (http://www.sec.gov/ thereunder,2 a proposed rule change to Clearing Agencies, and establishes a rules/sro.shtml). Copies of the amend its listing rules to permit uniform policy at the Clearing Agencies. submission, all subsequent companies whose business plan is to The proposed changes to the Investment amendments, all written statements complete one or more business Policy would not affect any changes on with respect to the proposed rule combinations (‘‘SPACs’’ or ‘‘Acquisition the fundamental purpose or operation of change that are filed with the Companies’’) 15 calendar days following this document and, as such, would also Commission, and all written the closing of a business combination to not have any impact, or impose any communications relating to the demonstrate that the SPAC has satisfied burden, on competition. proposed rule change between the the applicable round lot shareholder Commission and any person, other than requirement. The proposed rule change (C) Clearing Agency’s Statement on those that may be withheld from the was published for comment in the Comments on the Proposed Rule public in accordance with the Federal Register on September 22, Change Received From Members, provisions of 5 U.S.C. 552, will be 2020.3 On November 4, 2020, pursuant Participants, or Others available for website viewing and to Section 19(b)(2) of the Exchange Act,4 The Clearing Agencies have not printing in the Commission’s Public the Commission designated a longer solicited or received any written Reference Room, 100 F Street NE, period within which to approve the comments relating to this proposal. The Washington, DC 20549 on official proposed rule change, disapprove the Clearing Agencies will notify the business days between the hours of proposed rule change, or institute Commission of any written comments 10:00 a.m. and 3:00 p.m. Copies of the proceedings to determine whether to received by the Clearing Agencies. filing also will be available for disapprove the proposed rule change.5 On December 16, 2020, the Commission III. Date of Effectiveness of the inspection and copying at the principal office of NSCC and on DTCC’s website instituted proceedings under Section Proposed Rule Change, and Timing for 19(b)(2)(B) of the Act 6 to determine Commission Action (http://dtcc.com/legal/sec-rule- filings.aspx). All comments received whether to approve or disapprove the Within 45 days of the date of will be posted without change. Persons proposed rule change.7 On February 25, publication of this notice in the Federal submitting comments are cautioned that 2021, the Exchange filed Amendment Register or within such longer period we do not redact or edit personal No. 1 to the proposed rule change, up to 90 days (i) as the Commission may identifying information from comment which superseded the proposed rule designate if it finds such longer period submissions. You should submit only change as originally filed, and is to be appropriate and publishes its information that you wish to make described in Items I and II below, which reasons for so finding or (ii) as to which available publicly. All submissions Items have been prepared by the the self-regulatory organization should refer to File Number SR–NSCC– Exchange. The Commission is consents, the Commission will: 2021–003 and should be submitted on publishing this notice to solicit (A) By order approve or disapprove or before April 6, 2021. comments on the proposed rule change, such proposed rule change, or as modified by Amendment No. 1, from (B) institute proceedings to determine For the Commission, by the Division of interested persons. whether the proposed rule change Trading and Markets, pursuant to delegated authority.16 I. Self-Regulatory Organization’s should be disapproved. J. Matthew DeLesDernier, Statement of the Terms of Substance of IV. Solicitation of Comments Assistant Secretary. the Proposed Rule Change Interested persons are invited to [FR Doc. 2021–05347 Filed 3–15–21; 8:45 am] The Exchange proposes to amend submit written data, views and BILLING CODE 8011–01–P listing rules applicable to companies arguments concerning the foregoing, whose business plan is to complete one including whether the proposed rule or more business combinations (the change is consistent with the Act. SECURITIES AND EXCHANGE ‘‘Original Proposal’’). The Exchange is Comments may be submitted by any of COMMISSION filing this proposal (‘‘Amendment No. 1’’) to amend the Original Proposal. the following methods: [Release No. 34–91294; File No. SR– Amendment No. 1 supersedes the Electronic Comments NASDAQ–2020–062]

• 1 Use the Commission’s internet Self-Regulatory Organizations; The 15 U.S.C. 78s(b)(1). comment form (http://www.sec.gov/ 2 17 CFR 240.19b–4. Nasdaq Stock Market LLC; Notice of 3 rules/sro.shtml); or Filing of Proposed Rule Change, as See Securities Exchange Act Release No. 89897 • (September 16, 2020), 85 FR 59574. Comments Send an email to rule-comments@ Modified by Amendment, No. 1, To received on the proposal are available on the sec.gov. Please include File Number SR– Amend Listing Rules Applicable to Commission’s website at: https://www.sec.gov/ NSCC–2021–003 on the subject line. comments/sr-nasdaq-2020-062/ Special Purpose Acquisition srnasdaq2020062.htm. Paper Comments Companies Whose Business Plan is To 4 15 U.S.C. 78s(b)(2). Complete One or More Business 5 • Send paper comments in triplicate See Securities Exchange Act Release No. 90340, Combinations 85 FR 71704 (November 10, 2020). The Commission to Secretary, Securities and Exchange designated December 21, 2020, as the date by which Commission, 100 F Street NE, March 10, 2021. it should approve, disapprove, or institute Washington, DC 20549. proceedings to determine whether to disapprove the On September 3, 2020, The Nasdaq proposed rule change. All submissions should refer to File Stock Market LLC (‘‘Nasdaq’’ or 6 15 U.S.C. 78s(b)(2)(B). Number SR–NSCC–2021–003. This file 7 See Securities Exchange Act Release No. 90682, number should be included on the 16 17 CFR 200.30–3(a)(12). 85 FR 83113 (December 16, 2020).

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Original Proposal in its entirety to add combination.10 If a shareholder vote on the broker-dealers.12 If the company can an additional disclosure requirement. the business combination is held, public provide information demonstrating shareholders voting against a business compliance before the business II. Self-Regulatory Organization’s combination must have the right to combination closes, no further Statement of the Purpose of, and convert their shares of common stock information would be required. Statutory Basis for, the Proposed Rule into a pro rata share of the aggregate However, Nasdaq has observed that in Change amount then in the escrow account (net some cases it can be difficult for a In its filing with the Commission, the of taxes payable and amounts company to obtain evidence Exchange included statements distributed to management for working demonstrating the number of concerning the purpose of and basis for capital purposes) if the business shareholders that it has or will have the proposed rule change and discussed combination is approved and following a business combination. As any comments it received on the consummated.11 If the combined noted above, shareholders of an proposed rule change. The text of these company does not meet the initial Acquisition Company may redeem or statements may be examined at the listing requirements following a tender their shares until just before the places specified in Item IV below. The business combination, Nasdaq Staff will time of the business combination, and Exchange has prepared summaries, set issue a Staff Delisting Determination the company may not know how many forth in sections A, B, and C below, of under Nasdaq Rule 5810. shareholders will choose to redeem the most significant aspects of such Under the existing rules, ‘‘following until very close to the consummation of statements. each business combination’’ with an the business combination. In cases A. Self-Regulatory Organization’s Acquisition Company, the resulting where the number of round lot Statement of the Purpose of, and company must satisfy all initial listing shareholders is close to the applicable Statutory Basis for, the Proposed Rule requirements. The rule does not provide requirement, this could affect the ability Change a timetable for the company to for Nasdaq to determine compliance demonstrate that it satisfies those before the business combination closes. 1. Purpose requirements, however. Accordingly, Accordingly, for a company that has Nasdaq is filing this amendment to Nasdaq proposes to modify the rule to demonstrated that it will satisfy all SR–NASDAQ–2020–062, which was specify if the Acquisition Company initial listing requirements except for published for comment by the demonstrates that it will satisfy all the round lot shareholder requirement Commission on September 16, 2020.8 requirements except the applicable before consummating the business The original proposal would allow round lot shareholder requirement, then combination, Nasdaq will allow the certain acquisition companies listed the company will receive 15 calendar company 15 calendar days after the under IM–5101–2 with a 15-day period days following the closing to closing of the business combination, if after closing a business combination to demonstrate that it satisfied the necessary, to demonstrate that it also provide evidence that the combined applicable round lot shareholder complied with the round lot company satisfied the round lot requirement immediately following the requirement at the time of the business shareholder requirement for initial transaction’s closing. combination. To be clear, the company listing at the time of the business Ordinarily, in determining must still demonstrate that it satisfied combination. This Amendment No. 1 compliance with the round lot the round lot shareholder requirement would require a company relying on shareholder requirement at the time of immediately following the business this 15-day period to file a Form 8–K, a business combination, Nasdaq will combination; the proposal is merely were required by SEC rules, or issue a review a company’s public disclosures giving the company 15 calendars days to press release noting that the company is and information provided by the provide evidence that it did. relying upon the additional 15 calendar company about the transaction. For Providing Acquisition Companies days available under Nasdaq rules to example, the merger agreement may with an additional 15 days to demonstrate compliance. result in the Acquisition Company demonstrate compliance with the round In 2009, Nasdaq adopted additional issuing a round lot of shares to more lot rule as of the date of the business listing requirements for a company than 300 holders of the target of the combination will result in the whose business plan is to complete an business combination at closing. If continuation of the listing of companies initial public offering and engage in a public information is not available that that have completed a business merger or acquisition with one or more enables Nasdaq to determine combination but not yet demonstrated unidentified companies within a compliance, Nasdaq will typically that they satisfied all initial listing specific period of time (‘‘Acquisition request that the company provide requirements. For this reason, the Companies’’).9 Such a company is additional information such as Exchange proposes that each required to keep at least 90% of the registered shareholder lists from the Acquisition Company that has not proceeds from its initial public offering company’s transfer agent, data from demonstrated compliance with the in an escrow account and, until the Cede & Co. about shares held in street applicable round lot shareholder company has completed one or more name, or data from broker-dealers and requirement on the date of the business business combinations having an from third parties that distribute combination’s closing will be required aggregate fair market value of at least information such as proxy materials for to issue a press release or file a Form 8– 80% of the value of the escrow account, K, if required, prior to closing of the must meet the requirements for initial 10 See Nasdaq Rule IM–5101–2(d) and (e). business combination, stating that the listing following each business 11 See Nasdaq Rule IM–5101–2(d). If a company is relying upon the additional shareholder vote on the business combination is not 15 calendar days available under held, the company must provide all shareholders 8 Securities Exchange Act Release No. 99897 with the opportunity to redeem their shares for cash Nasdaq rules to demonstrate (September 22, 2020), 85 FR 59574 (September 16, equal to their pro rata share of the aggregate amount 2020). then in the deposit account (net of taxes payable 12 Companies must seek this information from 9 Securities Exchange Act Release No. 58228 (July and amounts distributed to management for third parties because many accounts are held in 25, 2008), 73 FR 44794 (July 31, 2008) (adopting the working capital purposes). Nasdaq Rule IM–5101– street name and shareholders may object to being predecessor to IM–5101–2). 2(e). identified to the company.

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compliance. The company also will be Acquisition Company to provide for the prohibition or limitation by the required to note that in the event it is evidence before completing the business Exchange of any person with respect to unable to demonstrate compliance, the combination that it will satisfy all access to services offered. The proposed company will be subject to delisting. In requirements for initial listing, except rule change accounts for the particular the event the Acquisition Company does for the round lot shareholder difficulties encountered by Acquisition not make the required public disclosure requirement. While the proposed rule Companies when attempting to prior to the closing of the business would allow Acquisition Companies 15 determine their total number of combination, Nasdaq will halt trading in calendar days, if needed, to provide shareholders due to the ability of the company’s securities until such time evidence that they also complied with shareholders to redeem their shares. as the required announcement is made the round lot shareholder requirement Acquisition Companies will still be public. at the time of the business combination, required to demonstrate compliance Nasdaq believes that this proposal that additional time is a reasonable with all initial listing standards balances the burden placed on the accommodation given both the immediately following the business Acquisition Company to obtain accurate difficulty companies face in identifying combination, which is the initial listing shareholder information for the new their shareholders and the ability for the of the combined company. This is no entity and the need to ensure that a Acquisition Company’s shareholders to different from the requirements imposed company that does not satisfy the initial redeem their shares when the business on other newly listing companies. listing requirements following a combination is consummated. In that The non-substantive changes to business combination enters the regard, Acquisition Companies are eliminate a duplicate paragraph in delisting process promptly. If the unlike other newly listing companies, paragraphs (d) and (e) of IM–5101–2 and company does not evidence compliance which do not face redemptions and are to add a new paragraph designation will within the proposed time period, not already listed and trading at the improve the rule’s readability and Nasdaq staff would issue a delisting time they must demonstrate thereby remove an impediment to a free determination, which the company compliance. Importantly, the company and open market and a national market could appeal to an independent must still demonstrate that it satisfied system and help to better protect Hearings Panel as described in the 5800 the round lot shareholder requirement investors, which Nasdaq believes is Series of the Nasdaq Rules. Nasdaq also immediately following the business consistent with the requirements of believes that the disclosure requirement combination. The proposed rule also Section 6(b)(5) of the Act.15 will help provide transparency to requires an Acquisition Company B. Self-Regulatory Organization’s investors about the status of the utilizing the additional 15 day period Statement on Burden on Competition company during this time. after closing of the business Finally, Nasdaq proposes a non- combination to file a Form 8–K, were The Exchange does not believe that substantive change to eliminate a required by SEC rules, or issue a press the proposed rule change will impose duplicate paragraph in paragraphs (d) release, prior to the closing of the any burden on competition not and (e) of IM–5101–2 and to add a new business combination, noting that the necessary or appropriate in furtherance paragraph designation. company is relying upon the additional of the purposes of the Act. The 2. Statutory Basis 15 calendar days available under proposed rule would clarify that a company listing in connection with a The Exchange believes that its Nasdaq rules to demonstrate merger with an Acquisition Company proposal is consistent with Section 6(b) compliance. The company must also must provide evidence before of the Act,13 in general, and furthers the note that in the event it is unable to completing the business combination objectives of Section 6(b)(5) of the Act,14 demonstrate compliance, the company that it will satisfy all requirements for in particular, in that it is designed to will be subject to delisting. In the event initial listing, although a reasonable promote just and equitable principles of the Acquisition Company does not make accommodation would be made to allow trade, to remove impediments to and the required disclosure prior to the the company to demonstrate compliance perfect the mechanism of a free and listing of the combined company, with the round lot shareholder open market and a national market Nasdaq will halt trading in the requirement before issuing a delisting system, and, in general to protect company’s securities until such time as letter if that is the only requirement that investors and the public interest, by the required announcement is made the company cannot demonstrate imposing a specific timeline for public. The Exchange believes this compliance with before completing the Acquisition Companies to demonstrate disclosure requirement will ensure that business combination. This change is that they will comply with the initial prospective investors are aware that the not expected to have any impact on listing requirements following a company has not yet demonstrated that competition. business combination and allowing a it meets the shareholder requirement reasonable period of time for the and therefore may be delisted. In light C. Self-Regulatory Organization’s company to provide evidence that it of these requirements, Nasdaq believes Statement on Comments on the complied with the round lot that the proposed rule change Proposed Rule Change Received From shareholder requirement at the time of appropriately balances the protection of Members, Participants, or Others prospective investors with the the business combination. On December 21, 2020, the The proposed rule would specify the protection of shareholders of the Commission issued an Order Instituting time when an Acquisition Company Acquisition Company, the latter of Proceedings 16 (‘‘OIP’’) pursuant to must demonstrate compliance with the whom would be harmed if Nasdaq Section 19(b)(2)(B) of the Act to initial listing standards following the issued a delisting determination at a determine whether to approve or completion of a business combination, time when the company did, in fact, disapprove the Original Proposal thereby enhancing investor protection. satisfy all initial listing requirements but could not yet provide proof. Specifically, it would require an 15 15 U.S.C. 78f(b)(5). The proposed rule change is also 16 Securities Exchange Act Release No. 90682 13 15 U.S.C. 78f(b). consistent with Section 6(b)(7) of the (December 21, 2021), 85 FR 83113 (December 16, 14 15 U.S.C. 78f(b)(5). Act in that it provides a fair procedure 2020).

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superseded by this Amendment No. 1. received will be posted without change. for enforcing compliance with LTSE In response to the OIP, the Council of Persons submitting comments are Rule 14.425, which requires listed Institutional Investors (‘‘CII’’) submitted cautioned that we do not redact or edit Companies 4 to adopt and publish Long- a comment letter dated January 7, personal identifying information from Term Policies consistent with a defined 2021.17 Simultaneous to the submission comment submissions. You should set of principles (the ‘‘Principles’’) of this Amendment No. 1, the Exchange submit only information that you wish articulated in LTSE Rule 14.425(b).5 As is submitting a comment letter in to make available publicly. All the Exchange states, LTSE Rule response to the Commission’s OIP. That submissions should refer to File 14.425(a) requires Companies to adopt comment letter addresses the issues Number SR–NASDAQ–2020–062, and and publish the following policies: A raised in the CII comment letter. should be submitted on or before April Long-Term Stakeholder Policy; a Long- Term Strategy Policy; a Long-Term III. Solicitation of Comments 6, 2021. Compensation Policy; a Long-Term Interested persons are invited to For the Commission, by the Division of Trading and Markets, pursuant to delegated Board Policy; and a Long-Term Investor submit written data, views, and authority.18 Policy (collectively, the ‘‘Policies’’).6 arguments concerning the foregoing, J. Matthew DeLesDernier, LTSE Rule 14.425(b) establishes that including whether the proposed rule Assistant Secretary. Companies have flexibility in change, as modified by Amendment No. developing what they believe to be [FR Doc. 2021–05345 Filed 3–15–21; 8:45 am] 1, is consistent with the Act. Comments appropriate policies for their businesses may be submitted by any of the BILLING CODE 8011–01–P on condition that each of the Policies following methods: must be consistent with the Principles.7 Electronic Comments SECURITIES AND EXCHANGE Under LTSE Rule 14.425(c), Companies also are required to review their Policies • Use the Commission’s internet COMMISSION at least annually, make them publicly comment form (http://www.sec.gov/ [Release No. 34–91287; File No. SR–LTSE– available free of charge on or through rules/sro.shtml); or 2021–01] • Send an email to rule-comments@ their websites, and provide related disclosures in certain filings with the sec.gov. Please include File Number SR– Self-Regulatory Organizations; Long- 8 NASDAQ–2020–062 on the subject line. Commission. In addition, the Exchange Term Stock Exchange, Inc.; Order has represented to the Commission that Paper Comments Approving Proposed Rule Change To it will enforce the provisions of LTSE • Amend LTSE Rule 14.501 To Specify Rule 14.425 by ensuring that each Send paper comments in triplicate the Process for Enforcing Compliance to Secretary, Securities and Exchange Company has addressed all of the With LTSE Rule 14.425 for Listed requirements enumerated for each of the Commission, 100 F Street NE, Companies Washington, DC 20549–1090. prescribed Policies, consistent with the All submissions should refer to File March 10, 2021. Principles, and that each Company has Number SR–NASDAQ–2020–062. This made the Policies publicly available I. Introduction 9 file number should be included on the without cost. subject line if email is used. To help the On January 19, 2021, Long-Term Currently, LTSE states that it enforces Commission process and review your Stock Exchange, Inc. (‘‘LTSE’’ or the provisions of LTSE Rule 14.425 comments more efficiently, please use ‘‘Exchange’’) filed with the Securities through a number of rules in the LTSE 10 only one method. The Commission will and Exchange Commission Rulebook. The Exchange notes that, post all comments on the Commission’s (‘‘Commission’’) pursuant to Section under LTSE Rule 14.101, the Exchange internet website (http://www.sec.gov/ 19(b)(1) of the Securities Exchange Act may at all times exercise its broad rules/sro.shtml). Copies of the of 1934 (‘‘Act’’) 1 and Rule 19b–4 discretionary authority to suspend or submission, all subsequent thereunder,2 a proposed rule change to delist Companies based on any event, amendments, all written statements amend Rule 14.501(d)(2)(A)(iii) to condition, or circumstance that exists or with respect to the proposed rule specify the process for enforcing change that are filed with the compliance with LTSE Rule 14.425, 4 ‘‘Company’’ means the issuer of a security listed or applying to list on the Exchange. For purposes Commission, and all written which requires each listed company of of Chapter 14 of the LTSE Rules, the term communications relating to the the Exchange to adopt and publish ‘‘Company’’ includes an issuer that is not proposed rule change between the ‘‘Long-Term Policies’’ as set forth in the incorporated, such as, for example, a limited Commission and any person, other than rule. The proposed rule change was partnership. See LTSE Rule 14.002(a)(5). those that may be withheld from the published for comment in the Federal 5 See Notice, supra note 3, at 8244. LTSE Rule Series 14.500 sets forth the procedures of the 3 public in accordance with the Register on February 4, 2021. No Exchange relating to a Company’s failure to meet provisions of 5 U.S.C. 552, will be comment letters were received in the listing standards in Chapter 14 of the available for website viewing and response to the Notice. This order Exchange’s rules, which comprises the corporate printing in the Commission’s Public approves the proposed rule change. governance standards set forth in Rule Series 14.400, including Rule 14.425 regarding Long-Term Reference Room, 100 F Street NE, II. Description of the Proposed Rule Policies. Washington, DC 20549 on official 6 Change See id. See also Securities Exchange Act Release business days between the hours of No. 86722 (August 21, 2019), 84 FR 44952 (August 10:00 a.m. and 3:00 p.m. Copies of the The Exchange proposes to amend 27, 2019) (SR–LTSE–2019–01) (‘‘Long-Term Rule 14.501(d)(2)(A)(iii) to specify the Policies Approval Order’’) (Order Approving filing also will be available for Proposed Rule Change To Adopt Rule 14.425, inspection and copying at the principal process under LTSE Rule Series 14.500 Which Would Require Companies Listed on the office of the Exchange. All comments Exchange To Develop and Publish Certain Long- 18 17 CFR 200.30–3(a)(12). Term Policies). 7 17 See Letter from Jeffrey P. Mahoney, Council of 1 15 U.S.C. 78s(b)(1). See Notice, supra note 3, at 8244. Institutional Investors Letter to Secretary, Securities 2 17 CFR 240.19b–4. 8 See id. and Exchange Commission (January 7, 2021). CII 3 See Securities Exchange Act Release No. 91019 9 See id. See also Long-Term Policies Approval also raised concerns with the SPAC structure that (January 29, 2021), 86 FR 8243 (February 4, 2021) Order, supra note 6, at 44954. are outside the scope of Nasdaq’s proposal. (‘‘Notice’’). 10 See Notice, supra note 3, at 8244.

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occurs that makes initial or continued The Exchange proposes to amend Reprimand Letter in accordance with listing of the securities on the Exchange LTSE Rule 14.501(d)(2)(A)(iii) to specify LTSE Rule 14.501(d)(4).26 Under LTSE inadvisable or unwarranted in the that deficiencies relating to LTSE Rule Rule 14.500(a), a Public Reprimand opinion of the Exchange to protect 14.425 would be included among those Letter or Staff Delisting Determination, investors and the public interest, among for which a Company may submit a Plan upon timely request by a Company, is other objectives.11 Under LTSE Rule of Compliance for staff review.20 The subject to review by a Listings Review 14.500(a), LTSE staff is responsible for Exchange states that this would be Committee, which will adjudicate the identifying deficiencies that may lead to similar to how other corporate request in accordance with the delisting.12 Under LTSE Rule 14.410, a governance rules are handled generally procedures and timelines set forth in Company is required to provide the in LTSE Rule 14.501(d)(2)(A)(iii).21 LTSE Rules 14.502, 14.504, and Exchange with prompt notification after Under LTSE Rule 14.501(d)(2)(C), a 14.505.27 an Executive Officer of the Company Company has 45 calendar days to The Exchange asserts that providing becomes aware of any noncompliance submit a plan to regain compliance.22 an opportunity for remediation to by the Company with the LTSE Rule According to the Exchange, LTSE staff Companies that face a deficiency with Series 14.400, which includes Rule may extend this deadline for up to an respect to LTSE Rule 14.425 will allow 14.425.13 Under LTSE Rule 14.207(a)(1), additional five calendar days upon good Companies to formulate effective the Exchange may request any cause shown and may request such Policies tailored to Company-specific additional information or additional information from the needs.28 The Exchange argues that the documentation, public or non-public, Company as is necessary to make a ability to tailor Policies, if necessary, to deemed necessary to make a determination regarding whether to changing circumstances, while determination regarding a Company’s grant such an extension.23 The remaining anchored to the Principles, is continued listing, and a Company may Exchange asserts that this time period essential for ensuring that the Policies be denied continued listing if it fails to appropriately balances the interests of are effective and meaningful tools for provide such information within a the Exchange in ensuring compliance supporting long-term value creation for reasonable period of time.14 In addition, with its listing standards with the Companies and their investors.29 To that the Exchange states that it plans to application of principles-based listing end, the Exchange maintains that, in monitor Company compliance with standards by the Company.24 case of a deficiency, Companies will be Rule 14.425 annually and on an ad hoc According to the Exchange, the able to achieve compliance by changing basis.15 process for reviewing such a Plan of Policies or practices related to the Finally, LTSE Rule 14.501 sets forth Compliance is set forth in LTSE Rule deficiency, amending the applicable the provisions regarding the Exchange’s 14.501(d)(2)(B) and would be Policies, or some combination of both, process for notifying Companies unchanged by this proposal.25 Under provided that the changes are consistent regarding different types of deficiencies that provision, the Exchange may with the Principles.30 and their corresponding provide the Company with up to 180 consequences.16 The Exchange states days to regain compliance (with certain III. Discussion and Commission that there are four types of Company exceptions), issue a Staff Delisting Findings deficiency notifications that the Determination letter, or issue a Public The Commission has carefully Exchange may issue pursuant to LTSE reviewed the proposed rule change and Rule 14.501(a): (i) Staff Delisting 20 See id. at 8244. The proposed rule change would also remove two erroneous ‘‘or’’s in LTSE finds that it is consistent with the Determinations, which are notifications 31 Rule 14.501(d)(2)(A)(iii). See id. at 8244 n.8. requirements of Section 6 of the Act. of deficiencies that, unless appealed, 21 See id. (citing LTSE Rules 14.408(a) (Meetings In particular, the Commission finds that subject the Company to immediate of Shareholders), 14.408(c) (Quorum), the proposed rule change is consistent suspension and delisting; (ii) 14.411(Review of Related Party Transactions), with Section 6(b)(5) of the Act,32 which notifications of deficiencies for which 14.412 (Shareholder Approval), 14.406 (Code of Conduct), 14.407(a)(4)(D) (Partner Meetings of requires, among other things, that rules the Company may submit a plan of Limited Partners), 14.407(a)(4)(E) (Quorum of of a national securities exchange be compliance (‘‘Plan of Compliance’’) for Limited Partnerships), 14.407(a)(4)(G) (Related designed to prevent fraudulent and staff review; (iii) notifications of Party Transactions of Limited Partnerships), 14.413 manipulative acts and practices, to (Voting Rights), and 14.414 (Internal Audit deficiencies for which a Company is promote just and equitable principles of entitled to an automatic cure or Function)). 22 See id. at 8244. trade, to remove impediments to and compliance period; and (iv) Public 23 See id. perfect the mechanism of a free and 17 Reprimand Letters. LTSE Rule 24 See id. The Exchange also states that, open market and a national market 14.501(d) identifies the deficiencies that notwithstanding the mandated period to submit a system, and, in general, to protect fall within each of these four Plan of Compliance and regain compliance under investors and the public interest, and categories,18 and provides that in the LTSE Rule 14.501(d)(2), as set forth in LTSE Rule 14.501(c) and repeated in LTSE Rule 14.207(b)(2), that those rules are not designed to case of a deficiency not specified in ‘‘a listed Company that receives a notification of LTSE Rule 14.501(d)(1)–(4), LTSE staff deficiency from the Exchange is required to make 26 See id. a public announcement by filing a Form 8–K, where will issue either a Staff Delisting 27 See id. required by [Commission] rules, or by issuing a Determination or a Public Reprimand 28 See id. at 8245. 19 press release disclosing receipt of the notification Letter. and the Rule(s) upon which the deficiency is based, 29 See id. and describing each specific basis and concern 30 See id. For the avoidance of doubt, the 11 See id. at 8245. identified by the Exchange in reaching its Exchange states that each Company shall be solely 12 See id. at 8244. determination that the Company does not meet the responsible for ensuring any changes in its practices to conform to its Policies do not violate any legal, 13 See id. listing standard.’’ For avoidance of doubt, the Exchange further states that a request for regulatory, contractual, or other requirements 14 See id. information by LTSE staff pursuant to LTSE Rule applicable to the Company. See id. at 8245 n.11. 15 See id. at 8244 n.6. 14.207(a)(1), absent a notification of deficiency, will 31 15 U.S.C. 78f. In approving this proposed rule 16 See id. at 8244. not require a public announcement by the subject change, the Commission has considered the 17 See id. Company pursuant to LTSE Rules 14.501(c) or proposed rule’s impact on efficiency, competition, 18 See id. 14.207(b)(2). See id. at 8244 n.9. and capital formation. See 15 U.S.C. 78c(f). 19 See id. at 8244 n.7. 25 See id. at 8244. 32 15 U.S.C. 78f(b)(5).

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permit unfair discrimination between modify the action being taken in the and will become effective as soon as the customers, issuers, brokers, or dealers. investigation by suspending the internal procedures on both sides are The Commission notes that the additional tariffs on goods of the completed. proposed rule change will bring the European Union for a period of four This will allow the EU and the US to ease Exchange’s handling of deficiencies in a the burden on their industries and workers months. The suspension is in accord and focus efforts towards resolving these long Company’s compliance with LTSE Rule with a joint U.S.-EU statement that running disputes at the WTO. 14.425 into alignment with its handling promotes a resolution of the large civil The EU and the US are committed to reach of deficiencies in a Company’s aircraft dispute. a comprehensive and durable negotiated compliance with other LTSE Rules DATES: As of 12:01 a.m. eastern standard solution to the Aircraft disputes. Key pertaining to corporate governance,33 as time on March 11, 2021, the additional elements of a negotiated solution will detailed in the adjudicatory process set duties on products of the European include disciplines on future support in this forth in LTSE Rule Series 14.500. The sector, outstanding support measures, Union covered by the action taken in monitoring and enforcement, and addressing Commission further notes that any this investigation are suspended for a Company listed on LTSE would already the trade distortive practices of and period of four months. challenges posed by new entrants to the have had to adopt and publish Long- FOR FURTHER INFORMATION CONTACT: For sector from non-market economies, such as Term Policies prior to being accepted questions about the investigation or this China. for listing. The Commission therefore notice, contact Associate General These steps signal the determination of believes it is reasonable to afford a Counsel Megan Grimball, at (202) 395– both sides to embark on a fresh start in the Company the opportunity to submit a relationship. 5725, or Director for Europe Michael Plan of Compliance should a deficiency Rogers, at (202) 395–3320. Promoting a successful resolution of subsequently arise in this area. The SUPPLEMENTARY INFORMATION: the dispute by suspending the Commission notes in this regard that, in additional duties provides benefits to addition to submitting a Plan of A. Proceedings in the Investigation the U.S. economy that outweigh any Compliance, a listed Company that For background on the proceedings in adverse impacts on the U.S. economy, receives a deficiency notification from and the suspension maintains the the Exchange is required to make a this investigation, please see prior notices, including: Notice of initiation, credibility of the section 301 action. public announcement that discloses its Accordingly, the U.S. Trade receipt of the notification and the basis 84 FR 15028 (April 12, 2019); notice of determination and action, 84 FR 54245 Representative has determined, in for it, and that such announcement must accordance with sections 307(a) and be made as promptly as possible but not (October 9, 2019); and notices concerning revisions or modifications of 301(a)(2)(B)(iv) of the Trade Act, to more than four business days following modify the action by suspending the 34 action, 85 FR 10204 (February 21, 2020), receipt of the notification. Based on additional duties on products of the the foregoing, the Commission finds that 85 FR 50866 (August 18, 2020), 86 FR 674 (January 6, 2021), 86 FR 9420 European Union for four months. The the proposed rule change is consistent decision to modify the action takes into with the Act. (February 12, 2021), and FR Doc. 2021– 05035 (March 11, 2021). account the public comments received IV. Conclusion in response to prior notices issued in B. Modification of Action the investigation as well as the advice It is therefore ordered, pursuant to of the interagency Section 301 Section 19(b)(2) of the Act,35 that the Section 307(a) of the Trade Act of 1974, as amended, (Trade Act) provides Committee. proposed rule change (SR–LTSE–2021– To give effect to the U.S. Trade 01), be, and hereby is, approved. that the U.S. Trade Representative may modify or terminate any action subject Representative’s determination, as For the Commission, by the Division of to the specific direction, if any, of the specified in the Annex to this notice, Trading and Markets, pursuant to delegated President with respect to such action, the additional duties imposed by authority.36 that is being taken under section 301 if subheadings 9903.89.05, 9903.89.07, J. Matthew DeLesDernier, any of the conditions described in 9903.89.10, 9903.89.13, 9903.89.16, Assistant Secretary. section 301(a)(2) exist. Section 9903.89.19, 9903.89.22, 9903.89.25, [FR Doc. 2021–05340 Filed 3–15–21; 8:45 am] 301(a)(2)(B)(iv) of the Trade Act 9903.89.28, 9903.89.31, 9903.89.34, BILLING CODE 8011–01–P provides that the U.S. Trade 9903.89.37, 9903.89.40, 9903.89.43, Representative is not required to take 9903.89.46, 9903.89.52, 9903.89.55, action under section 301(a)(1) ‘‘in 9903.89.57, 9903.89.59, 9903.89.61, and OFFICE OF THE UNITED STATES extraordinary cases, where the taking of 9903.89.63, and as provided by their TRADE REPRESENTATIVE action . . . would have an adverse associated subchapter notes, will not impact on the United States economy apply to products of Austria, Belgium, Notice of Modification of Section 301 substantially out of proportion to the Bulgaria, Croatia, Republic of Cyprus, Action: Enforcement of U.S. WTO benefits of such action, taking into Czech Republic, Denmark, Estonia, Rights in the Large Civil Aircraft account the impact of not taking such Finland, France, Germany, Greece, Dispute action on the credibility of [actions Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, AGENCY: Office of the United States taken under section 301].’’ Netherlands, Poland, Portugal, Romania, Trade Representative (USTR). On March 5, 2021, the United States and the European Union issued a Joint Slovakia, Slovenia, Spain, and Sweden, ACTION: Notice. Statement promoting a resolution of the that are entered for consumption, or SUMMARY: The U.S. Trade large civil aircraft dispute: withdrawn from warehouse for consumption, on or after 12:01 a.m. Representative has determined to The European Union and the United States today agreed on the mutual suspension for eastern standard time on March 11, 33 See supra note 21 and accompanying text. four months of the tariffs related to the World 2021, and before 12:01 a.m. eastern 34 See LTSE Rule 14.501(c); supra note 24. Trade Organization (WTO) Aircraft disputes. daylight time on July 11, 2021. 35 15 U.S.C. 78s(b)(2). The suspension will cover all tariffs both on Any product of Austria, Belgium, 36 17 CFR 200.30–3(a)(12). aircraft as well as on non-aircraft products, Bulgaria, Croatia, Republic of Cyprus,

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Czech Republic, Denmark, Estonia, 9903.89.28, 9903.89.31, 9903.89.34, Ground Floor at 1200 New Jersey Finland, France, Germany, Greece, 9903.89.37, 9903.89.40, 9903.89.43, Avenue SE, Washington, DC 20590– Hungary, Ireland, Italy, Latvia, 9903.89.46, 9903.89.52, 9903.89.55, 0001, between 9 a.m. and 5 p.m., Lithuania, Luxembourg, Malta, 9903.89.57, 9903.89.59, 9903.89.61, and 9903.89.63 and as provided by their Monday through Friday, except Federal Netherlands, Poland, Portugal, Romania, associated subchapter notes, shall not apply holidays. Slovakia, Slovenia, Spain, and Sweden, to articles the product of Austria, Belgium, • Fax: Fax comments to Docket that was admitted into a U.S. foreign Bulgaria, Croatia, Republic of Cyprus, Czech Operations at (202) 493–2251. trade zone in ‘privileged foreign status’ Republic, Denmark, Estonia, Finland, France, as defined in 19 CFR 146.41, before Germany, Greece, Hungary, Ireland, Italy, Privacy: In accordance with 5 U.S.C. 12:01 a.m. eastern standard time on Latvia, Lithuania, Luxembourg, Malta, 553(c), DOT solicits comments from the March 11, 2021, will remain subject to Netherlands, Poland, Portugal, Romania, public to better inform its rulemaking the applicable duties in subheadings Slovakia, Slovenia, Spain, and Sweden that process. DOT posts these comments, 9903.89.05, 9903.89.07, 9903.89.10, are entered on or after 12:01 a.m. eastern without edit, including any personal standard time on March 11, 2021 and before 9903.89.13, 9903.89.16, 9903.89.19, 12:01 a.m. eastern daylight time on July 11, information the commenter provides, to 9903.89.22, 9903.89.25, 9903.89.28, 2021.’’ http://www.regulations.gov, as 9903.89.31, 9903.89.34, 9903.89.37, described in the system of records 9903.89.40, 9903.89.43, 9903.89.46, Greta M. Peisch, notice (DOT/ALL–14 FDMS), which can 9903.89.52, 9903.89.55, 9903.89.57, General Counsel, Office of the United States be reviewed at http://www.dot.gov/ 9903.89.59, 9903.89.61, and 9903.89.63 Trade Representative. privacy. upon entry for consumption. [FR Doc. 2021–05354 Filed 3–15–21; 8:45 am] Docket: Background documents or Any product of Austria, Belgium, BILLING CODE 3290–F1–P Bulgaria, Croatia, Republic of Cyprus, comments received may be read at Czech Republic, Denmark, Estonia, http://www.regulations.gov at any time. Finland, France, Germany, Greece, DEPARTMENT OF TRANSPORTATION Follow the online instructions for Hungary, Ireland, Italy, Latvia, accessing the docket or go to the Docket Lithuania, Luxembourg, Malta, Federal Aviation Administration Operations in Room W12–140 of the West Building Ground Floor at 1200 Netherlands, Poland, Portugal, Romania, [Summary Notice No. 2021–2060] Slovakia, Slovenia, Spain, and Sweden New Jersey Avenue SE, Washington, DC covered by subparagraph 2 of the Annex Petition for Exemption; Summary of 20590–0001, between 9 a.m. and 5 p.m., to this notice, that is admitted into a Petition Received; Airlines for America Monday through Friday, except Federal U.S. foreign trade zone on or after 12:01 holidays. a.m. eastern standard time on March 11, AGENCY: Federal Aviation FOR FURTHER INFORMATION CONTACT: 2021, and before 12:01 a.m. eastern Administration (FAA), Department of Nia daylight time on July 11, 2021, may be Transportation (DOT). Daniels, (202) 267–7626, Office of admitted in any status, as applicable, as ACTION: Notice. Rulemaking, Federal Aviation defined in 19 CFR 146, Subpart D. Administration, 800 Independence The U.S. Trade Representative will SUMMARY: This notice contains a Avenue SW, Washington, DC 20591. continue to consider the action taken in summary of a petition seeking relief This notice is published pursuant to this investigation. from specified requirements of Federal 14 CFR 11.85. Aviation Regulations. The purpose of Annex this notice is to improve the public’s Issued in Washington, DC. Effective with respect to articles the awareness of, and participation in, the Timothy R. Adams, product of Austria, Belgium, Bulgaria, FAA’s exemption process. Neither Deputy Executive Director, Office of Croatia, Republic of Cyprus, Czech Republic, publication of this notice nor the Rulemaking. Denmark, Estonia, Finland, France, Germany, inclusion or omission of information in Greece, Hungary, Ireland, Italy, Latvia, the summary is intended to affect the Petition for Exemption Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, legal status of the petition or its final Docket No.: FAA–2021–0079. disposition. Slovenia, Spain, and Sweden that are entered Petitioner: Airlines for America. for consumption, or withdrawn from DATES: Comments on this petition must warehouse for consumption, on or after 12:01 identify the petition docket number and Section of 14 CFR Affected: a.m. eastern standard time on March 11, 121.463(c). 2021, and entered for consumption, or must be received on or before April 5, withdrawn from warehouse for consumption, 2021. Description of Relief Sought: Airlines before 12:01 a.m. eastern daylight time on ADDRESSES: Send comments identified for America (A4A), on behalf of its July 11, 2021: by docket number FAA–2021–0079 member airlines, petitions for relief 1. Note 21(a) to subchapter III of chapter using any of the following methods: from § 121.463(c). The relief, if granted, 99 of the Harmonized Tariff Schedule of the • Federal eRulemaking Portal: Go to would suspend the requirement for United States is modified by deleting ‘‘Except as provided in note 21(u) of this http://www.regulations.gov and follow aircraft dispatcher operating subdivision,’’ and by inserting ‘‘Except as the online instructions for sending your familiarization flights until March 31, provided in notes 21(u) and 21(v) of this comments electronically. 2022. The petition seeks to allow subdivision,’’ in lieu thereof. • Mail: Send comments to Docket dispatchers who have completed 2. Note 21 to subchapter III of chapter 99 Operations, M–30; U.S. Department of operating familiarization flights in of the Harmonized Tariff Schedule of the Transportation, 1200 New Jersey previous years to remain qualified United States is modified by inserting in Avenue SE, Room W12–140, West without exposing them and flight crew alphabetical order: Building Ground Floor, Washington, DC ‘‘(v) The U.S. Trade Representative has members to an increased risk for determined that additional duties imposed 20590–0001. exposure to COVID–19. • Hand Delivery or Courier: Take by subheadings 9903.89.05, 9903.89.07, [FR Doc. 2021–05432 Filed 3–15–21; 8:45 am] 9903.89.10, 9903.89.13, 9903.89.16, comments to Docket Operations in 9903.89.19, 9903.89.22, 9903.89.25, Room W12–140 of the West Building BILLING CODE 4910–13–P

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DEPARTMENT OF TRANSPORTATION SUPPLEMENTARY INFORMATION: At DCA, U.S. and foreign air carriers, Public Comments Invited: Public including commuter operators, must Federal Aviation Administration comment is invited on any aspect of this notify the FAA of: (1) Written consent [Docket No. FAA–2021–0067] information collection, including (a) and requests for confirmation of slot Whether the proposed collection of transfers; (2) slots required to be Agency Information Collection information is necessary for FAA’s returned and slots voluntarily returned; Activities: Requests for Comments; performance; (b) the accuracy of the (3) requests to be included in a lottery Clearance of Renewed Approval of estimated burden; (c) ways for FAA to for the permanent allocation of available Information Collection: High Density enhance the quality, utility and clarity slots; (4) reports on usage of slots on a Traffic Airports; Slot Allocation and of the information collection; and (d) bi-monthly basis; and (5) requests for Transfer Methods ways that the burden could be slots in low-demand hours or other minimized without reducing the quality temporary allocations. Operators must AGENCY: Federal Aviation of the collected information. The agency obtain a reservation from the FAA prior Administration (FAA), DOT. will summarize and/or include your to conducting an unscheduled ACTION: Notice and request for comments in the request for OMB’s operation. At LGA, U.S. and foreign air comments. clearance of this information collection. carriers must notify the FAA of: (1) OMB Control Number: 2120–0524. Written consent and requests for SUMMARY: In accordance with the Title: High Density Traffic Airports; confirmation of slot transfers; (2) slots Paperwork Reduction Act of 1995, FAA Slot Allocation and Transfer Methods. required to be returned and slots invites public comments about our Form Numbers: There are no FAA voluntarily returned; (3) requests to be intention to request approval from the forms associated with this collection. included in a lottery for the permanent Office of Management and Budget Type of Review: Renewal of an allocation of available slots; and (4) (OMB) to renew a currently approved information collection. reports usage of slots on a bi-monthly information collection. The FAA Background: The FAA has basis. Carriers must also request and collects information from U.S. and implemented several initiatives to obtain a reservation from the FAA prior foreign air carriers holding a slot at address air traffic congestion and delay to conducting an unscheduled Ronald Reagan Washington National at certain airports within the National operation. At JFK, U.S. and foreign air Airport (DCA), John F. Kennedy Airspace System (NAS). DCA slot rules carriers must notify the FAA of: (1) International Airport (JFK), and are established under 14 CFR part 93, Written consent and requests for LaGuardia Airport (LGA); operating subparts K and S. The FAA has issued confirmation of slot transfers; (2) scheduled flights at Newark Liberty Orders limiting operations at JFK and requests for seasonal allocation of International Airport (EWR), Los LGA.1 These Orders resulted from historic and additional available slots; Angeles International Airport (LAX), increasing congestion and delays at the (3) reports on usage of slots on a O’Hare International Airport (ORD), and airports requiring the FAA to allocate seasonal basis; (4) the return of slots; San Francisco International Airport arrival and departure slots at JFK and and (5) changes to allocated slots. At (SFO); and conducting unscheduled LGA. In addition, the FAA has EWR, LAX, ORD, and SFO, all carriers operations at DCA and LGA. The designated EWR, ORD, SFO, and LAX as are asked to notify the FAA of their information collected is necessary to Level 2 schedule-facilitated airports intended operating schedules during support the advance management of air under the IATA Worldwide Slot designated hours on a semiannual basis traffic demand by the FAA Slot Guidelines (WSG) now known as the (for each winter and summer scheduling Administration in an effort to reduce Worldwide Airport Slot Guidelines season) based on the IATA WASG potential delays. The FAA proposes (WASG).2 At Level 2 airports, the FAA Calendar of Coordination Activities and renaming this information collection to seeks the cooperation of all carriers provide updates throughout the year ‘‘FAA Runway Slot Administration and planning operations, on a voluntary when there are significant schedule Schedule Analysis’’ to more accurately basis, to maintain close communications changes. The FAA estimates that all reflect the collection of information on runway schedules and facilitate information from carriers is submitted related to multiple airports subject to adjustments, as needed. different FAA regulatory and voluntary electronically from data stored in carrier scheduling databases. Requests for processes under this program. 1 Operating Limitations at John F. Kennedy DATES: Written comments should be International Airport, 73 FR 3510 (Jan. 18, 2008), as unscheduled flight reservations are submitted by May 17, 2021. most recently amended 85 FR 58258 (Sep. 18, submitted electronically via the 2020); Operating Limitations at New York internet. The FAA also proposes to re- ADDRESSES: Send comments on this LaGuardia Airport, 71 FR 77854 (Dec. 27, 2006), as name the collection to ‘‘FAA Runway most recently amended 85 FR 58255 (Sep. 18, proposal to the U.S. Department of Slot Administration and Schedule Transportation, Docket Operations, 1200 2020). 2 Analysis’’ to more accurately reflect the New Jersey Avenue SE, West Building Notice of Submission Deadline for Schedule Information for O’Hare International, John F. collection of information related to Ground Floor, Room W12–140, Kennedy International, and Newark Liberty multiple airports subject to different Washington, DC 20590–0001; telephone: International Airports for the Summer 2009 FAA regulatory and voluntary (800) 647–5527, or (202) 366–9826. You Scheduling Season, 73 FR 54659 (Sept. 22, 2008); Notice of Submission Deadline for Schedule processes. must identify FAA Docket Number Information for San Francisco International Airport Respondents: 119 unique carriers; FAA–2021–0067 at the beginning of for the Summer 2012 Scheduling Season, 76 FR unknown number of carriers conducting your comments. You may also submit 64163 (Oct. 17, 2011); Notice of Submission unscheduled operations at LGA and comments through the internet at Deadline for Schedule Information for Los Angeles International Airport for the Summer 2015 DCA. https://www.regulations.gov. Scheduling Season 80 FR 12253 (Mar. 6, 2015); Frequency: Information is collected as FOR FURTHER INFORMATION CONTACT: Notice of Change of Newark Liberty International needed; some reporting on bimonthly or Matthew Gonabe, FAA Slot Airport Designation, 81 FR 19861 (Apr. 6, 2016). semiannual basis. The FAA reaffirmed the Level 2 designations by 85 Administration, by email at: FR 65134 (Oct. 14, 2020). These designations Estimated Average Burden per [email protected]; phone: (609) remain effective until the FAA announces a change Response: 6 minutes per slot transaction 485–9554. in the Federal Register. per respondent (i.e., transferor and

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transferee); 6 minutes per slot return; 6 Privacy: In accordance with 5 U.S.C. the emergency drills or performance minutes per schedule update; 6 minutes 553(c), DOT solicits comments from the drills using the normal procedures. per request for inclusion in a lottery; 2 public to better inform its rulemaking [FR Doc. 2021–05431 Filed 3–15–21; 8:45 am] minutes per unscheduled slot request; process. DOT posts these comments, BILLING CODE 4910–13–P 1.5 hours per schedule submission; and without edit, including any personal 1 hour per slot usage report. information the commenter provides, to Estimated Total Annual Burden: http://www.regulations.gov, as DEPARTMENT OF TRANSPORTATION 5602.6 hours. described in the system of records Issued in Washington, DC, on March 10, notice (DOT/ALL–14 FDMS), which can Federal Motor Carrier Safety 2021. be reviewed at http://www.dot.gov/ Administration privacy. Matthew S. Gonabe, [Docket No. FMCSA–2020–0224] Program Specialist, FAA Slot Administration. Docket: Background documents or [FR Doc. 2021–05334 Filed 3–15–21; 8:45 am] comments received may be read at Controlled Substances and Alcohol http://www.regulations.gov at any time. BILLING CODE 4910–13–P Use and Testing: FirstGroup plc. Follow the online instructions for Application for Exemption From the accessing the docket or go to the Docket Drug and Alcohol Clearinghouse Pre- DEPARTMENT OF TRANSPORTATION Operations in Room W12–140 of the Employment Full Query West Building Ground Floor at 1200 Federal Aviation Administration New Jersey Avenue SE, Washington, DC AGENCY: Federal Motor Carrier Safety 20590–0001, between 9 a.m. and 5 p.m., Administration (FMCSA), DOT. [Summary Notice No. 2021–2062] Monday through Friday, except Federal ACTION: Notice of application for Petition for Exemption; Summary of holidays. exemption; request for comments. Petition Received; Airlines for America FOR FURTHER INFORMATION CONTACT: Nia SUMMARY: FMCSA announces that Daniels, (202) 267–9677, Office of AGENCY: FirstGroup plc (FirstGroup) has applied Federal Aviation Rulemaking, Federal Aviation Administration (FAA), Department of for an exemption on behalf of three of Administration, 800 Independence its subsidiaries, First Student, Inc., First Transportation (DOT). Avenue SW, Washington, DC 20591. ACTION: Notice. Transit, Inc., and First Mile Square, This notice is published pursuant to which employ commercial driver’s SUMMARY: This notice contains a 14 CFR 11.85. license (CDL) holders subject to drug summary of a petition seeking relief Issued in Washington, DC. and alcohol testing. FirstGroup requests from specified requirements of Federal Timothy R. Adams, an exemption from the requirement that Aviation Regulations. The purpose of Deputy Executive Director, Office of an employer must conduct a full query this notice is to improve the public’s Rulemaking. of FMCSA’s Drug and Alcohol awareness of, and participation in, the Clearinghouse (Clearinghouse) before FAA’s exemption process. Neither Petition for Exemption employing a CDL holder to perform publication of this notice nor the Docket No.: FAA–2020–0307. safety-sensitive functions. Under the inclusion or omission of information in Petitioner: Airlines for America. requested exemption, in lieu of a full the summary is intended to affect the Section(s) of 14 CFR Affected: query, FirstGroup would conduct a legal status of the petition or its final 121.407(c)(2), 121.409(b)(2)(i), limited pre-employment query of the disposition. 121.417(c)(2)(i)(C)–(D) and (E)(4), Clearinghouse. If the limited query DATES: Comments on this petition must 121.424(a)(1), 121.427(b)(2)(i)–(iii), indicated that information about the identify the petition docket number and (e)(1)(ii) and (e)(2), 121.441(b)(1), and driver existed in the Clearinghouse, must be received on or before March 22, 121.805(b)(5)(iii) FirstGroup would then conduct a full 2021. Description of Relief Sought: The query of the Clearinghouse, with the driver-applicant providing consent in ADDRESSES: petitioner requests an extension and Send comments identified the Clearinghouse as required. In by docket number FAA–2020–0307 amendment of Exemption No. 18512C to allow certificate holders to use addition, FirstGroup would conduct a using any of the following methods: second limited query within 30 to 35 • Federal eRulemaking Portal: Go to alternative methods to conduct certain days of the initial limited query and http://www.regulations.gov and follow required crewmember emergency conduct multiple limited queries on all the online instructions for sending your procedures during recurrent, its CDL drivers each year thereafter. comments electronically. conversion, and upgrade training, • Mail: Send comments to Docket checking, and evaluation until DATES: Comments must be received on Operations, M–30; U.S. Department of September 30, 2021. The petitioner or before April 15, 2021. Transportation, 1200 New Jersey seeks an amendment to the Conditions ADDRESSES: You may submit comments Avenue SE, Room W12–140, West and Limitations of Exemption No. identified by Federal Docket Building Ground Floor, Washington, DC 18512C, which require a crewmember Management System Number FMCSA– 20590–0001. using alternative methods to complete 2020–0224 by any of the following • Hand Delivery or Courier: Take the drills using the normal procedures methods: comments to Docket Operations in during the person’s next regularly • Federal eRulemaking Portal: Room W12–140 of the West Building scheduled recurrent ground training or www.regulations.gov. See the Public Ground Floor at 1200 New Jersey within 12 calendar months (plus grace Participation and Request for Comments Avenue SE, Washington, DC 20590– month) of the training using the section below for further information. 0001, between 9 a.m. and 5 p.m., alternative methods, whichever is • Mail: Dockets Operations, U.S. Monday through Friday, except Federal earlier. The petitioner seeks an Department of Transportation, 1200 holidays. amendment to allow up to 24 calendar New Jersey Avenue SE, West Building, • Fax: Fax comments to Docket months after use of the alternative Ground Floor, Room W12–140, Operations at (202) 493–2251. methods for crewmembers to complete Washington, DC 20590–0001.

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• Hand Delivery or Courier: West body of your document so the Agency Clearinghouse. A full query allows the Building, Ground Floor, Room W12– can contact you if it has questions employer to see any information that 140, 1200 New Jersey Avenue SE, regarding your submission. exists about a driver in the between 9 a.m. and 5 p.m. E.T., Monday To submit your comment online, go to Clearinghouse. An employer must through Friday, except Federal holidays. www.regulations.gov and put the docket obtain the driver’s specific consent, • Fax: (202) 493–2251. number, ‘‘FMCSA–2020–0224’’ in the provided electronically through the Each submission must include the ‘‘Keyword’’ box, and click ‘‘Search.’’ Clearinghouse, prior to the release of Agency name and the docket number for When the new screen appears, click on detailed information provided in this notice (FMCSA–2020–0224). Note ‘‘Comment Now!’’ button and type your response to the full query. that DOT posts all comments received comment into the text box in the A limited query is permitted to satisfy without change to www.regulations.gov, following screen. Choose whether you the annual query requirement in 49 CFR including any personal information are submitting your comment as an 382.701(b)(1), which pertains to included in a comment. Please see the individual or on behalf of a third party currently employed drivers. The limited Privacy Act heading below. and then submit. If you submit your query, conducted after obtaining the Docket: For access to the docket to comments by mail or hand delivery, driver’s general consent, will tell the read background documents or submit them in an unbound format, no employer whether information about the comments, go to www.regulations.gov at larger than 81⁄2 by 11 inches, suitable for individual driver exists in the any time or visit Room W12–140 on the copying and electronic filing. If you Clearinghouse but will not release that ground level of the West Building, 1200 submit comments by mail and would information to the employer. General New Jersey Avenue SE, Washington, like to know that they reached the consent is obtained and retained outside DC, between 9 a.m. and 5 p.m., ET, facility, please enclose a stamped, self- the Clearinghouse and may be in written Monday through Friday, except Federal addressed postcard or envelope. FMCSA or electronic form. If the response to a holidays. To be sure someone is there to will consider all comments and material limited query indicates there is help you, please call (202) 366–9317 or received during the comment period. information about the driver in the (202) 366–9826 before visiting Dockets II. Legal Basis Clearinghouse, the employer must Operations. conduct a full query, after obtaining the Privacy Act: In accordance with 5 FMCSA has authority under 49 U.S.C. driver’s specific consent, within 24 U.S.C. 553(c), DOT solicits comments 31136(e) and 31315 to grant exemptions hours, as required by 49 CFR from the public to better inform its from certain Federal Motor Carrier 382.701(b)(3). regulatory exemptions process. DOT Safety Regulations. FMCSA must posts these comments, without edit, publish a notice of each exemption Applicant’s Request including any personal information the request in the Federal Register (49 CFR FirstGroup requests an exemption commenter provides, to 381.315(a)). The Agency must provide from the rule prohibiting an employer www.regulations.gov, as described in the public an opportunity to inspect the from employing a driver subject to drug the system of records notice (DOT/ALL– information relevant to the application, and alcohol testing requirements to 14 FDMS), which can be reviewed at including any safety analyses that have perform safety-sensitive functions www.dot.gov/privacy. been conducted. The Agency must also without first conducting a full query of FOR FURTHER INFORMATION CONTACT: Mr. provide an opportunity for public the Clearinghouse. Under the requested Richard Clemente, FMCSA Driver and comment on the request. exemption, FirstGroup would, in lieu of Carrier Operations Division; Office of The Agency reviews safety analyses a full query, conduct a limited pre- Carrier, Driver and Vehicle Safety and public comments submitted, and employment query of the Clearinghouse Standards; (202) 366–2722; MCPSD@ determines whether granting the before one of its members employed a dot.gov. If you have questions on exemption would likely achieve a level driver. If the limited query indicated viewing or submitting material to the of safety equivalent to, or greater than, that information about the driver exists docket, contact Dockets Operations, the level that would be achieved absent in the Clearinghouse, FirstGroup would (202) 366–9826. the exemption (49 U.S.C 31315(b)(1)). then conduct a full query of the The decision of the Agency must be SUPPLEMENTARY INFORMATION: Clearinghouse, with the driver applicant published in the Federal Register (49 providing consent in the Clearinghouse I. Public Participation and Request for CFR 381.315(b)) with the reasons for as required. In addition, FirstGroup Comments denying or granting the application and, would conduct a second limited query if granted, the name of the person or FMCSA encourages you to participate within 30 to 35 days of the initial query, class of persons receiving the by submitting comments and related would conduct quarterly limited queries exemption, and the regulatory provision materials. on all its CDL drivers for the first year from which the exemption is granted. of the exemption, and for years 2 Submitting Comments The notice must specify the effective through 5, would conduct semi-annual If you submit a comment, please period (up to 5 years) and explain the limited queries on all its CDL drivers. include the docket number for this terms and conditions of the exemption. FirstGroup believes the requirements notice (FMCSA–2020–0224), indicate The exemption may be renewed (49 CFR of 49 CFR 382.701(a)(2) is hindering its the specific section of this document to 381.300(b)). ability to hire at the speed and level which the comment applies, and III. Background needed to keep pace with the demands provide a reason for suggestions or of the contracted school and transit recommendations. You may submit Current Regulation Requirements transportation industry. FirstGroup also your comments and material online or Under 49 CFR 382.701(a)(2) believes the exemption is needed since by fax, mail, or hand delivery, but employers of CDL holders must not the delays and administrative costs please use only one of these means. employ a driver subject to the testing related to conducting a full query during FMCSA recommends that you include requirements of 49 CFR part 382 FirstGroup’s driver hiring process is your name and a mailing address, an without first conducting a pre- resulting in hundreds of thousands of email address, or a phone number in the employment full query of the dollars of increased costs.

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A copy of FirstGroup’s exemption individuals from the vision requirement the DOT West Building, 1200 New application is included in the docket in the Federal Motor Carrier Safety Jersey Avenue SE, Washington, DC referenced above. Regulations (FMCSRs) for interstate 20590–0001, between 9 a.m. and 5 p.m., commercial motor vehicle (CMV) ET, Monday through Friday, except IV. Request for Comments drivers. The exemptions enable these Federal holidays. To be sure someone is In accordance with 49 U.S.C. individuals to continue to operate CMVs there to help you, please call (202) 366– 31315(b), FMCSA requests public in interstate commerce without meeting 9317 or (202) 366–9826 before visiting comment from all interested persons on the vision requirement in one eye. Dockets Operations. FirstGroup’s application for an DATES: Each group of renewed B. Privacy Act exemption from § 382.701(a)(2). All exemptions were applicable on the comments received before the close of dates stated in the discussions below In accordance with 5 U.S.C. 553(c), business on the comment closing date and will expire on the dates provided DOT solicits comments from the public indicated at the beginning of this notice below. to better inform its rulemaking process. will be considered and will be available DOT posts these comments, without for examination in the docket at the FOR FURTHER INFORMATION CONTACT: Ms. edit, including any personal information location listed under the ADDRESSES Christine A. Hydock, Chief, Medical the commenter provides, to section of this notice. Comments Programs Division, (202) 366–4001, www.regulations.gov, as described in received after the comment closing date [email protected], FMCSA, the system of records notice (DOT/ALL– will be filed in the public docket and Department of Transportation, 1200 14 FDMS), which can be reviewed at will be considered to the extent New Jersey Avenue SE, Room W64–224, www.transportation.gov/privacy. practicable. In addition to late Washington, DC 20590–0001. Office comments, FMCSA will continue to file, hours are from 8:30 a.m. to 5 p.m., ET, II. Background in the public docket, relevant Monday through Friday, except Federal On January 7, 2021, FMCSA information that becomes available after holidays. If you have questions published a notice announcing its the comment closing date. Interested regarding viewing or submitting decision to renew exemptions for 66 persons should continue to examine the material to the docket, contact Dockets individuals from the vision requirement public docket for new material. Operations, (202) 366–9826. in 49 CFR 391.41(b)(10) to operate a SUPPLEMENTARY INFORMATION: Larry W. Minor, CMV in interstate commerce and Associate Administrator for Policy. I. Public Participation requested comments from the public (86 FR 697). The public comment period [FR Doc. 2021–05328 Filed 3–15–21; 8:45 am] A. Viewing Comments ended on February 5, 2021, and one BILLING CODE 4910–EX–P To view comments go to comment was received. www.regulations.gov. Insert the docket FMCSA has evaluated the eligibility DEPARTMENT OF TRANSPORTATION number, FMCSA–2000–7006, FMCSA– of these applicants and determined that 2000–7165, FMCSA–2001–11426, renewing these exemptions would Federal Motor Carrier Safety FMCSA–2002–12294, FMCSA–2004– achieve a level of safety equivalent to, Administration 18885, FMCSA–2004–19477, FMCSA– or greater than, the level that would be achieved by complying with the current [Docket No. FMCSA—FMCSA–2000–7006; 2005–21711, FMCSA–2006–24783, FMCSA–2000–7165; FMCSA–2001–11426; FMCSA–2006–26066, FMCSA–2007– regulation § 391.41(b)(10). FMCSA–2002–12294; FMCSA–2004–18885; 0071, FMCSA–2008–0021, FMCSA– The physical qualification standard FMCSA–2004–19477; FMCSA–2005–21711; 2008–0106, FMCSA–2008–0174, for drivers regarding vision found in FMCSA–2006–24783; FMCSA–2006–26066; FMCSA–2008–0266, FMCSA–2008– § 391.41(b)(10) states that a person is FMCSA–2007–0071; FMCSA–2008–0021; 0292, FMCSA–2008–0340, FMCSA– physically qualified to drive a CMV if FMCSA–2008–0106; FMCSA–2008–0174; 2010–0161, FMCSA–2010–0187, that person has distant visual acuity of FMCSA–2008–0266; FMCSA–2008–0292; FMCSA–2010–0201, FMCSA–2010– at least 20/40 (Snellen) in each eye FMCSA–2008–0340; FMCSA–2010–0161; FMCSA–2010–0187; FMCSA–2010–0201; 0287, FMCSA–2010–0354, FMCSA– without corrective lenses or visual FMCSA–2010–0287; FMCSA–2010–0354; 2010–0385, FMCSA–2012–0039, acuity separately corrected to 20/40 FMCSA–2010–0385; FMCSA–2012–0039; FMCSA–2012–0161, FMCSA–2012– (Snellen) or better with corrective FMCSA–2012–0161; FMCSA–2012–0215; 0215, FMCSA–2012–0216, FMCSA– lenses, distant binocular acuity of a least FMCSA–2012–0216; FMCSA–2012–0279; 2012–0279, FMCSA–2013–0168, 20/40 (Snellen) in both eyes with or FMCSA–2013–0168; FMCSA–2013–0170; FMCSA–2013–0170, FMCSA–2014– without corrective lenses, field of vision FMCSA–2014–0002; FMCSA–2014–0006; 0002, FMCSA–2014–0006, FMCSA– of at least 70° in the horizontal meridian FMCSA–2014–0007; FMCSA–2014–0010; 2014–0007, FMCSA–2014–0010, in each eye, and the ability to recognize FMCSA–2014–0011; FMCSA–2014–0296; FMCSA–2014–0299; FMCSA–2014–0300; FMCSA–2014–0011, FMCSA–2014– the colors of traffic signals and devices FMCSA–2016–0028; FMCSA–2016–0030; 0296, FMCSA–2014–0299, FMCSA– showing red, green, and amber. 2014–0300, FMCSA–2016–0028, FMCSA–2016–0207; FMCSA–2016–0208; III. Discussion of Comments FMCSA–2016–0209; FMCSA–2016–0210; FMCSA–2016–0030, FMCSA–2016– FMCSA–2018–0010; FMCSA–2018–0207] 0207, FMCSA–2016–0208, FMCSA– FMCSA received one comment in this 2016–0209, FMCSA–2016–0210, proceeding and it was unrelated to the Qualification of Drivers; Exemption FMCSA–2018–0010, or FMCSA–2018– scope of this notice. Applications; Vision 0207 in the keyword box, and click IV. Conclusion AGENCY: Federal Motor Carrier Safety ‘‘Search.’’ Next, sort the results by Administration (FMCSA), Department ‘‘Posted (Newer-Older),’’ choose the first Based on its evaluation of the 66 of Transportation (DOT). notice listed, and click ‘‘Browse renewal exemption applications and ACTION: Notice of final disposition. Comments.’’ If you do not have access comments received, FMCSA confirms to the internet, you may view the docket its decision to exempt the following SUMMARY: FMCSA announces its online by visiting Dockets Operations in drivers from the vision requirement in decision to renew exemptions for 66 Room W12–140 on the ground floor of § 391.41(b)(10).

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In accordance with 49 U.S.C. 31136(e) 81 FR 70253; 81 FR 71173; 81 FR 72664; Michael J. Welle (MN) and 31315(b), the following groups of 81 FR 80161; 81 FR 81230; 81 FR 90046; Carl V. Wheeler (NC) drivers received renewed exemptions in 81 FR 90050; 81 FR 91239; 81 FR 94013; Earl L. White, Jr. (NH) the month of February and are 81 FR 96165; 81 FR 96178; 81 FR 96180; Joseph F. Wood (MS) discussed below. As of February 5, 81 FR 96191; 81 FR 96196; 82 FR 13048; The drivers were included in docket 2021, and in accordance with 49 U.S.C. 83 FR 3861; 83 FR 6925; 83 FR 18633; numbers FMCSA–2000–7006; FMCSA– 31136(e) and 31315, the following 63 83 FR 28325; 83 FR 28342; 83 FR 34661; 2000–7165; FMCSA–2001–11426; individuals have satisfied the renewal 83 FR 53724; 83 FR 56140; 83 FR 56902; FMCSA–2002–12294; FMCSA–2004– conditions for obtaining an exemption 84 FR 2309; 84 FR 2311; 84 FR 2314): 18885; FMCSA–2004–18885; FMCSA– from the vision requirement in the Lennie D. Baker, Jr. (NC) 2004–19477; FMCSA–2005–21711; FMCSRs for interstate CMV drivers (65 Donald L. Blakeley II (NV) FMCSA–2006–24783; FMCSA–2006– FR 20245; 65 FR 33406; 65 FR 57230; Timothy Bradford (TN) 26066; FMCSA–2007–0071; FMCSA– 65 FR 57234; 67 FR 10471; 67 FR 19798; Scott Brady (FL) 2008–0021; FMCSA–2008–0106; 67 FR 46016; 67 FR 57266; 67 FR 57627; Marty R. Brewster (KS) FMCSA–2008–0174; FMCSA–2008– 69 FR 19611; 69 FR 51346; 69 FR 52741; David S. Brumfield (KY) 0266; FMCSA–2008–0292; FMCSA– 69 FR 53493; 69 FR 62742; 69 FR 64806; Todd A. Carlson (MN) 2008–0340; FMCSA–2010–0161; 70 FR 2705; 70 FR 48797; 70 FR 61493; Dionicio Carrera (TX) FMCSA–2010–0187; FMCSA–2010– 71 FR 26602; 71 FR 32183; 71 FR 41310; Juan Castanon (NM) 0201; FMCSA–2010–0287; FMCSA– 71 FR 50970; 71 FR 53489; 71 FR 62147; Scott F. Chalfant (DE) 2010–0354; FMCSA–2010–0385; 71 FR 62148; 71 FR 63379; 72 FR 1050; Derrick L. Cowan (NC) FMCSA–2012–0039; FMCSA–2012– 72 FR 1051; 72 FR 1056; 72 FR 64273; Dorothy J. Crum (OH) 0161; FMCSA–2012–0215; FMCSA– 73 FR 6242; 73 FR 6244; 73 FR 15567; Louis J. Cullen (NJ) 2012–0216; FMCSA–2012–0279; 73 FR 16950; 73 FR 16952; 73 FR 27015; Larry G. Davis (TN) FMCSA–2013–0168; FMCSA–2013– 73 FR 27018; 73 FR 35197; 73 FR 35198; Christopher L. Depuy (OH) 0170; FMCSA–2014–0002; FMCSA– 73 FR 36955; 73 FR 38498; 73 FR 38499; Craig E. Dorrance (MT) 2014–0006; FMCSA–2014–0007; 73 FR 48273; 73 FR 48275; 73 FR 51336; Lucious J. Erwin (TX) FMCSA–2014–0010; FMCSA–2014– 73 FR 51689; 73 FR 61922; ; 73 FR James H. Facemyre (WV) 0011; FMCSA–2014–0296; FMCSA– 61925; 73 FR 61925; 73 FR 63047; 73 FR Hector O. Flores (MD) 2014–0299; FMCSA–2016–0028; 74565; 73 FR 75803; 73 FR 75807; 73 FR Larry J. Folkerts (IA) FMCSA–2016–0030; FMCSA–2016– 76439; 73 FR 78421; 73 FR 78423; 74 FR Christopher K. Foot (NV) 0207; FMCSA–2016–0208; FMCSA– 6209; 74 FR 62632; 75 FR 9477; 75 FR Kelvin Frandin Bombu (KY) 2016–0209; FMCSA–2016–0210; 19674; 75 FR 22179; 75 FR 36778; 75 FR Stanley W. Goble (IA) FMCSA–2018–0010; FMCSA–2018– 36779; 75 FR 39725; 75 FR 44051; 75 FR John P. Grum (PA) 0207. Their exemptions were applicable 47883; 75 FR 50799; 75 FR 52062; 75 FR William R. Guida (PA) as of February 5, 2021, and will expire 54958; ; 75 FR 59327; 75 FR 59327; 75 Walter D. Hague, Jr. (VA) on February 5, 2023. FR 61833; 75 FR 63257; 75 FR 64396; Eric C. Hammer (MO) As of February 18, 2021, and in 75 FR 69737; 75 FR 70078; 75 FR 72863; Billy R. Hampton (NC) accordance with 49 U.S.C. 31136(e) and 75 FR 77591; 75 FR 77942; 75 FR 77949; Clifford J. Harris (VA) 31315, the following two individuals 75 FR 79079; 75 FR 79083; 75 FR 79084; Nylo K. Helberg (ND) have satisfied the renewal conditions for 76 FR 1499; 76 FR 2190; 76 FR 4413; 76 Robert K. Ipock (NC) obtaining an exemption from the vision FR 5425; 76 FR 70215; 77 FR 13689; 77 Jesse P. Jamison (TN) requirement in the FMCSRs for FR 20879; 77 FR 23797; 77 FR 31427; Perry D. Jensen (WI) interstate CMV drivers (80 FR 2473; 80 77 FR 36338; 77 FR 38384; 77 FR 41879; Robert E. Kelley (WA) FR 18693; 82 FR 13048; 84 FR 2314): 77 FR 46153; 77 FR 48590; 77 FR 52381; Lewis A. Kielhack (IL) Keith A. Looney (AR) and Van C. Mac 77 FR 52389; 77 FR 52391; 77 FR 56261; Gregory L. Kockelman (MN) (IL) 77 FR 60008; 77 FR 60010; 77 FR 64582; Matthew B. Lairamore (OK) The drivers were included in docket 77 FR 64583; 77 FR 64583; 77 FR 64841; Bradley W. Lovelace (NC) number FMCSA–2014–0030. Their 77 FR 65933; 77 FR 68200; 77 FR 68202; Duane R. Martin (PA) exemptions were applicable as of 77 FR 71671; 77 FR 74273; 77 FR 74730; John C. McLaughlin (SD) February 18, 2021, and will expire on 77 FR 74733; 77 FR 74734; 77 FR 75496; Rodney M. Pegg (PA) February 18, 2023. 77 FR 76166; 78 FR 797; 78 FR 63302; Chad M. Quarles (AL) As of February 25, 2021, and in 78 FR 64280; 78 FR 67454; 78 FR 77780; Joseph L. Rigsby (AL) accordance with 49 U.S.C. 31136(e) and 79 FR 4803; 79 FR 10606; 79 FR 10609; Joe A. Root (MN) 31315, the following individual has 79 FR 14331; 79 FR 22003; 79 FR 23797; Preston S. Salisbury (MT) satisfied the renewal conditions for 79 FR 35212; 79 FR 35218; 79 FR 35220; Benny L. Sanchez (CA) obtaining an exemption from the vision 79 FR 37843; 79 FR 38659; 79 FR 38661; Randal C. Schmude (WI) requirement in the FMCSRs for 79 FR 41735; 79 FR 45868; 79 FR 46153; James C. Sharp (PA) interstate CMV drivers (69 FR 64806; 70 79 FR 47175; 79 FR 51643; 79 FR 53514; Joseph B. Shaw, Jr. (VA) FR 2705; 72 FR 1056; 73 FR 76439; 75 79 FR 56097; 79 FR 56099; 79 FR 56104; Sylvester Silver (VA) FR 79084; 77 FR 75496; 80 FR 3723; 82 79 FR 56117; 79 FR 58856; 79 FR 59348; Kenneth D. Sisk (NC) FR 13048; 84 FR 2314): 79 FR 59357; 79 FR 64001; 79 FR 65759; Loren Smith (SD) Lester W. Carter (CA) 79 FR 65760; 79 FR 70928; 79 FR 72754; Paul W. Sorenson (UT) The driver was included in docket 79 FR 72756; 79 FR 73397; 79 FR 73686; David C. Stitt (KS) number FMCSA–2004–19477. The 79 FR 73687; 79 FR 73689; 79 FR 74169; Gary R. Thomas (OH) exemption was applicable as of 80 FR 3305; 80 FR 9304; 80 FR 63869; Richard T. Traigle (LA) February 25, 2021, and will expire on 80 FR 80443; 81 FR 20435; 81 FR 28138; David J. Triplett (KY) February 25, 2023. 81 FR 39320; 81 FR 45214; 81 FR 66720; Melvin V. Van Meter (PA) In accordance with 49 U.S.C. 81 FR 66726; 81 FR 70248; 81 FR 70251; Nicholas J. Vance (OH) 31315(b), each exemption will be valid

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for 2 years from the effective date unless being available in the docket, go to IV. Basis for Exemption Determination revoked earlier by FMCSA. The www.regulations.gov/ Under 49 U.S.C. 31136(e) and exemption will be revoked if the docket?D=FMCSA–2020–0015 and 31315(b), FMCSA may grant an following occurs: (1) The person fails to choose the document to review. If you exemption from the FMCSRs for no comply with the terms and conditions do not have access to the internet, you longer than a 5-year period if it finds of the exemption; (2) the exemption has may view the docket online by visiting such exemption would likely achieve a resulted in a lower level of safety than Dockets Operations in Room W12–140 level of safety that is equivalent to, or was maintained prior to being granted; on the ground floor of the DOT West greater than, the level that would be or (3) continuation of the exemption Building, 1200 New Jersey Avenue SE, achieved absent such exemption. The would not be consistent with the goals Washington, DC 20590–0001, between 9 statute also allows the Agency to renew and objectives of 49 U.S.C. 31136(e) and a.m. and 5 p.m., ET, Monday through exemptions at the end of the 5-year 31315(b). Friday, except Federal holidays. To be period. FMCSA grants medical sure someone is there to help you, Larry W. Minor, exemptions from the FMCSRs for a 2- please call (202) 366–9317 or (202) 366– year period to align with the maximum Associate Administrator for Policy. 9826 before visiting Dockets Operations. [FR Doc. 2021–05364 Filed 3–15–21; 8:45 am] duration of a driver’s medical B. Privacy Act certification. BILLING CODE 4910–EX–P The Agency’s decision regarding these In accordance with 5 U.S.C. 553(c), exemption applications is based on DOT solicits comments from the public medical reports about the applicants’ DEPARTMENT OF TRANSPORTATION to better inform its rulemaking process. vision, as well as their driving records DOT posts these comments, without and experience driving with the vision Federal Motor Carrier Safety edit, including any personal information deficiency. The qualifications, Administration the commenter provides, to experience, and medical condition of www.regulations.gov, as described in [Docket No. FMCSA–2020–0015] each applicant were stated and the system of records notice (DOT/ALL– discussed in detail in the January 7, Qualification of Drivers; Exemption 14 FDMS), which can be reviewed at 2021, Federal Register notice (86 FR Applications; Vision www.transportation.gov/privacy. 695) and will not be repeated here. AGENCY: Federal Motor Carrier Safety II. Background FMCSA recognizes that some drivers Administration (FMCSA), Department On January 7, 2021, FMCSA do not meet the vision requirement but of Transportation (DOT). published a notice announcing receipt have adapted their driving to ACTION: Notice of final disposition. of applications from seven individuals accommodate their limitation and requesting an exemption from vision demonstrated their ability to drive SUMMARY: FMCSA announces its requirement in 49 CFR 391.41(b)(10) safely. The seven exemption applicants decision to exempt seven individuals and requested comments from the listed in this notice are in this category. from the vision requirement in the public (86 FR 695). The public comment They are unable to meet the vision Federal Motor Carrier Safety period ended on February 5, 2021, and requirement in one eye for various Regulations (FMCSRs) to operate a one comment was received. reasons, including amblyopia, corneal commercial motor vehicle (CMV) in FMCSA has evaluated the eligibility scarring, ectopia lentis, optic nerve interstate commerce. They are unable to of these applicants and determined that hypoplasia, and retinal detachment. In meet the vision requirement in one eye granting the exemptions to these most cases, their eye conditions did not for various reasons. The exemptions individuals would achieve a level of develop recently. Five of the applicants enable these individuals to operate safety equivalent to, or greater than, the were either born with their vision CMVs in interstate commerce without level that would be achieved by impairments or have had them since meeting the vision requirement in one complying with § 391.41(b)(10). childhood. The two individuals that eye. The physical qualification standard developed their vision conditions as DATES: The exemptions were applicable for drivers regarding vision found in adults have had them for a range of 3 on February 5, 2021. The exemptions § 391.41(b)(10) states that a person is to 4 years. Although each applicant has expire on February 5, 2023. physically qualified to drive a CMV if one eye that does not meet the vision requirement in § 391.41(b)(10), each has FOR FURTHER INFORMATION CONTACT: Ms. that person has distant visual acuity of Christine A. Hydock, Chief, Medical at least 20/40 (Snellen) in each eye at least 20/40 corrected vision in the Programs Division, (202) 366–4001, without corrective lenses or visual other eye, and, in a doctor’s opinion, [email protected], FMCSA, acuity separately corrected to 20/40 has sufficient vision to perform all the Department of Transportation, 1200 (Snellen) or better with corrective tasks necessary to operate a CMV. Doctors’ opinions are supported by New Jersey Avenue SE, Room W64–224, lenses, distant binocular acuity of a least the applicants’ possession of a valid Washington, DC 20590–0001. Office 20/40 (Snellen) in both eyes with or license to operate a CMV. By meeting hours are from 8:30 a.m. to 5 p.m., ET, without corrective lenses, field of vision ° State licensing requirements, the Monday through Friday, except Federal of at least 70 in the horizontal meridian applicants demonstrated their ability to holidays. If you have questions in each eye, and the ability to recognize operate a CMV with their limited vision regarding viewing or submitting the colors of traffic signals and devices in intrastate commerce, even though material to the docket, contact Dockets showing red, green, and amber. their vision disqualified them from Operations, (202) 366–9826. III. Discussion of Comments driving in interstate commerce. We SUPPLEMENTARY INFORMATION: FMCSA received one comment in this believe that the applicants’ intrastate I. Public Participation proceeding. Tracy Ibinger submitted a driving experience and history provide comment stating that the Minnesota an adequate basis for predicting their A. Viewing Documents and Comments Department of Public Safety has no ability to drive safely in interstate To view comments, as well as any objections to the decision to grant an commerce. Intrastate driving, like documents mentioned in this notice as exemption to Burl V. Ingebretsen. interstate operations, involves

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substantial driving on highways on the exemption with respect to a person years. PATH states the installation of interstate system and on other roads operating under the exemption. such a device to deflect foreign objects built to interstate standards. Moreover, from the running rail could possibly VII. Conclusion driving in congested urban areas cause such an object to be deflected into exposes the driver to more pedestrian Based upon its evaluation of the seven the power rail, potentially causing and vehicular traffic than exists on exemption applications, FMCSA power outages or damage due to interstate highways. Faster reaction to exempts the following drivers from the electrical arcing. PATH also explains traffic and traffic signals is generally vision requirement, § 391.41(b)(10), the addition of a pilot would interfere required because distances between subject to the requirements cited above: with the transponder interrogator them are more compact. These Johnny J. Brown (MS) antennas that are currently installed as conditions tax visual capacity and Gordon L. Hendricks (TX) part of the Communications Based Train driver response just as intensely as Justin T. Hoben (IL) Control system. interstate driving conditions. Burl V. Ingebretsen (MN) A copy of the petition, as well as any The applicants in this notice have Weldon D. Rudder (OK) written communications concerning the driven CMVs with their limited vision Patrick W. Sargent (MT) petition, is available for review online at in careers ranging for 3 to 92 years. In John F. Skrobarczyk (TX) www.regulations.gov. the past 3 years, no drivers were In accordance with 49 U.S.C. 31136(e) Interested parties are invited to involved in crashes, and no drivers were and 31315(b), each exemption will be participate in these proceedings by convicted of moving violations in valid for 2 years from the effective date submitting written views, data, or CMVs. All the applicants achieved a unless revoked earlier by FMCSA. The comments. FRA does not anticipate record of safety while driving with their exemption will be revoked if the scheduling a public hearing in vision impairment that demonstrates the following occurs: (1) The person fails to connection with these proceedings since likelihood that they have adapted their comply with the terms and conditions the facts do not appear to warrant a driving skills to accommodate their of the exemption; (2) the exemption has hearing. If any interested parties desire condition. As the applicants’ ample resulted in a lower level of safety than an opportunity for oral comment and a driving histories with their vision was maintained prior to being granted; public hearing, they should notify FRA, deficiencies are good predictors of or (3) continuation of the exemption in writing, before the end of the future performance, FMCSA concludes would not be consistent with the goals comment period and specify the basis their ability to drive safely can be and objectives of 49 U.S.C. 31136(e) and for their request. projected into the future. 31315(b). All communications concerning these Consequently, FMCSA finds that in proceedings should identify the each case exempting these applicants Larry W. Minor, appropriate docket number and may be from the vision requirement in Associate Administrator for Policy. submitted by any of the following § 391.41(b)(10) is likely to achieve a [FR Doc. 2021–05366 Filed 3–15–21; 8:45 am] methods: • level of safety equal to that existing BILLING CODE 4910–EX–P Website: http:// without the exemption. www.regulations.gov. Follow the online instructions for submitting comments. V. Conditions and Requirements DEPARTMENT OF TRANSPORTATION • Fax: 202–493–2251. The terms and conditions of the • Mail: Docket Operations Facility, exemption are provided to the Federal Railroad Administration U.S. Department of Transportation applicants in the exemption document [Docket Number FRA–2008–0135] (DOT), 1200 New Jersey Ave. SE, W12– and includes the following: (1) Each 140, Washington, DC 20590. • driver must be physically examined Petition for Waiver of Compliance Hand Delivery: 1200 New Jersey every year (a) by an ophthalmologist or Ave. SE, Room W12–140, Washington, optometrist who attests that the vision Under part 211 of title 49 Code of DC 20590, between 9 a.m. and 5 p.m., in the better eye continues to meet the Federal Regulations (CFR), this Monday through Friday, except Federal standard in § 391.41(b)(10) and (b) by a document provides the public notice Holidays. certified medical examiner (ME) who that on February 22, 2021, the Port Communications received by April attests that the individual is otherwise Authority Trans-Hudson Corporation 30, 2021 will be considered by FRA physically qualified under § 391.41; (2) (PATH) petitioned the Federal Railroad before final action is taken. Comments each driver must provide a copy of the Administration (FRA) for an extension received after that date will be ophthalmologist’s or optometrist’s of a waiver of compliance from certain considered if practicable. report to the ME at the time of the provisions of the Federal railroad safety Anyone can search the electronic annual medical examination; and (3) regulations contained at 49 CFR part form of any written communications each driver must provide a copy of the 229, Railroad Locomotive Safety and comments received into any of our annual medical certification to the Standards. FRA assigned the petition dockets by the name of the individual employer for retention in the driver’s Docket Number FRA–2008–0135. submitting the comment (or signing the qualification file, or keep a copy in his/ Specifically, PATH requests document, if submitted on behalf of an her driver’s qualification file if he/she is continued relief from 49 CFR 229.123, association, business, labor union, etc.). self-employed. The driver must also Pilots, snowplows, end plates, which Under 5 U.S.C. 553(c), DOT solicits have a copy of the exemption when requires lead locomotives to be comments from the public to better driving, for presentation to a duly equipped with a pilot, snowplow, or inform its processes. DOT posts these authorized Federal, State, or local end plate that extends across both rails. comments, without edit, including any enforcement official. PATH further requests that the relief be personal information the commenter effective for the life of the current PATH provides, to www.regulations.gov, as VI. Preemption PA–5 fleet, noting that a waiver of this described in the system of records During the period the exemption is in same regulation covering the prior fleet notice (DOT/ALL–14 FDMS), which can effect, no State shall enforce any law or of PATH cars, as well as the current PA– be reviewed at https:// regulation that conflicts with this 5 fleet, has been in effect for over 31 www.transportation.gov/privacy. See

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also https://www.regulations.gov/ • Website: http:// locomotive EV 11 until March 2022, and privacyNotice for the privacy notice of www.regulations.gov. Follow the online 49 CFR 230.17(a), One thousand four regulations.gov. instructions for submitting comments. hundred seventy-two (1472) service day • Issued in Washington, DC. Fax: 202–493–2251. inspection, to extend the 1472-day • inspection to a 16-year interval. EV John Karl Alexy, Mail: Docket Operations Facility, U.S. Department of Transportation states that the COVID–19 public health Associate Administrator for Railroad Safety, emergency has caused EV to halt Chief Safety Officer. (DOT), 1200 New Jersey Ave. SE, W12– 140, Washington, DC 20590. excursion service, which resulted in EV [FR Doc. 2021–05373 Filed 3–15–21; 8:45 am] • Hand Delivery: 1200 New Jersey 11 only accumulating one service day BILLING CODE 4910–06–P Ave. SE, Room W12–140, Washington, since its 2020 annual inspection. EV DC 20590, between 9 a.m. and 5 p.m., anticipates operating EV 11 for about 40 service days in 2021. DEPARTMENT OF TRANSPORTATION Monday through Friday, except Federal Holidays. EV 11 is currently stored inside a Federal Railroad Administration Communications received by April shop building, and EV does not 30, 2021 will be considered by FRA anticipate operating the locomotive [Docket Number FRA–2021–0028] before final action is taken. Comments until May 2021 or later. received after that date will be A copy of the petition, as well as any Petition for Waiver of Compliance considered if practicable. Anyone can written communications concerning the Under part 211 of title 49 Code of search the electronic form of any written petition, is available for review online at Federal Regulations (CFR), this communications and comments www.regulations.gov. Interested parties are invited to document provides the public notice received into any of our dockets by the participate in these proceedings by that on February 16, 2021, the name of the individual submitting the submitting written views, data, or Walkersville Southern Railroad (WSRR) comment (or signing the document, if comments. FRA does not anticipate petitioned the Federal Railroad submitted on behalf of an association, scheduling a public hearing in Administration (FRA) for a waiver of business, labor union, etc.). Under 5 connection with these proceedings since compliance from certain provisions of U.S.C. 553(c), DOT solicits comments the facts do not appear to warrant a the Federal railroad safety regulations from the public to better inform its hearing. If any interested parties desire contained at 49 CFR part 215, Freight processes. DOT posts these comments, an opportunity for oral comment and a Car Safety Standards, and part 224, without edit, including any personal public hearing, they should notify FRA, Reflectorization. FRA assigned the information the commenter provides, to in writing, before the end of the petition Docket Number FRA–2021– www.regulations.gov, as described in comment period and specify the basis 0028 the system of records notice (DOT/ALL– 14 FDMS), which can be reviewed at for their request. Specifically, WSRR seeks a special All communications concerning these approval pursuant to 49 CFR 215.203, https://www.transportation.gov/privacy. See also https://www.regulations.gov/ proceedings should identify the Restricted cars, for one class N5 appropriate docket number and may be caboose, #477532, built in 1927. WSRR privacyNotice for the privacy notice of regulations.gov. submitted by any of the following also seeks a waiver of compliance from methods: the requirements of 49 CFR 215.303, Issued in Washington, DC. • Website: http:// Stenciling of restricted cars, and 49 CFR John Karl Alexy, www.regulations.gov. Follow the online part 224, Reflectorization, to maintain Associate Administrator for Railroad Safety, instructions for submitting comments. the historic nature of the car. WSRR Chief Safety Officer. • Fax: 202–493–2251. states it will maintain, service, and [FR Doc. 2021–05375 Filed 3–15–21; 8:45 am] • Mail: Docket Operations Facility, operate this caboose in excursion BILLING CODE 4910–06–P U.S. Department of Transportation service in Walkersville, Maryland, on (DOT), 1200 New Jersey Ave. SE, W12– other-than-main track, at speeds not 140, Washington, DC 20590. exceeding 10 miles per hour. DEPARTMENT OF TRANSPORTATION • Hand Delivery: 1200 New Jersey A copy of the petition, as well as any Ave. SE, Room W12–140, Washington, written communications concerning the Federal Railroad Administration DC 20590, between 9 a.m. and 5 p.m., petition, is available for review online at Monday through Friday, except Federal [Docket Number FRA–2021–0008] www.regulations.gov. Holidays. Interested parties are invited to Petition for Waiver of Compliance Communications received by April participate in these proceedings by 30, 2021 will be considered by FRA submitting written views, data, or Under part 211 of title 49 Code of before final action is taken. Comments comments. FRA does not anticipate Federal Regulations (CFR), this received after that date will be scheduling a public hearing in document provides the public notice considered if practicable. Anyone can connection with these proceedings since that on January 1, 2021, The Everett search the electronic form of any written the facts do not appear to warrant a Railroad Company (EV) petitioned the communications and comments hearing. If any interested parties desire Federal Railroad Administration (FRA) received into any of our dockets by the an opportunity for oral comment and a for a waiver of compliance from certain name of the individual submitting the public hearing, they should notify FRA, provisions of the Federal railroad safety comment (or signing the document, if in writing, before the end of the regulations contained at 49 CFR part submitted on behalf of an association, comment period and specify the basis 230, Steam Locomotive Inspection and business, labor union, etc.). Under 5 for their request. Maintenance Standards. FRA assigned U.S.C. 553(c), DOT solicits comments All communications concerning these the petition Docket Number FRA–2021– from the public to better inform its proceedings should identify the 0008. processes. DOT posts these comments, appropriate docket number and may be Specifically, EV requests relief from without edit, including any personal submitted by any of the following 49 CFR 230.16(a), Annual inspection, to information the commenter provides, to methods: extend the annual inspection interval on www.regulations.gov, as described in

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the system of records notice (DOT/ALL– Veterans will be held April 6–7, 2021 presentations from the public. Interested 14 FDMS), which can be reviewed at from 12:00 p.m. to 4:00 p.m. (Eastern parties should provide written https://www.transportation.gov/privacy. Standard Time). The virtual meetings comments on issues affecting homeless See also https://www.regulations.gov/ are open to the public. Veterans for review by the Committee to privacyNotice for the privacy notice of The purpose of the Committee is to Mr. Adam M. Ruege at Adam.Ruege2@ regulations.gov. provide the Secretary of Veterans Affairs va.gov and/or Ms. Leisa Davis at with an on-going assessment of the Issued in Washington, DC. [email protected]. effectiveness of the policies, John Karl Alexy, organizational structures, and services Members of the public who wish to Associate Administrator for Railroad Safety, of VA in assisting Veterans at-risk and virtually attend should contact Leisa Chief Safety Officer. experiencing homelessness. The Davis ([email protected]) of the [FR Doc. 2021–05374 Filed 3–15–21; 8:45 am] Committee shall assemble, and review Veterans Health Administration, BILLING CODE 4910–06–P information related to the needs of Homeless Programs Office no later than homeless Veterans and provide advice March 26, 2021, to provide their name, on the most appropriate means of professional affiliation, email address, DEPARTMENT OF VETERANS providing assistance to that subset of the and phone number. There will also be AFFAIRS Veteran population. The Committee will a call-in number at 1–800–767–1750; make recommendations to the Secretary access code: 53757. of Veterans Affairs regarding such Advisory Committee on Homeless Dated: March 10, 2021. Veterans; Notice of Meeting activities. The agenda will include briefings Jelessa M. Burney, The Department of Veterans Affairs from officials at VA and other Federal, Federal Advisory Committee Management (VA) gives notice under the Federal state, and local agencies regarding Officer. Advisory Committee Act, 5 U.S.C. services for homeless Veterans. [FR Doc. 2021–05326 Filed 3–15–21; 8:45 am] App.2, that virtual meetings of the No time will be allocated at this BILLING CODE 8320–01–P Advisory Committee on Homeless virtual meeting for receiving oral

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Reader Aids Federal Register Vol. 86, No. 49 Tuesday, March 16, 2021

CUSTOMER SERVICE AND INFORMATION CFR PARTS AFFECTED DURING MARCH

Federal Register/Code of Federal Regulations At the end of each month the Office of the Federal Register General Information, indexes and other finding 202–741–6000 publishes separately a List of CFR Sections Affected (LSA), which aids lists parts and sections affected by documents published since Laws 741–6000 the revision date of each title. 362...... 12122 Presidential Documents 3 CFR 381...... 12122 Executive orders and proclamations 741–6000 Proclamations: 533...... 12122 The United States Government Manual 741–6000 10149...... 11847 590...... 12122 10150...... 12515 592...... 12122 Other Services 10151...... 12517 Electronic and on-line services (voice) 741–6020 10152...... 12519 12 CFR Privacy Act Compilation 741–6050 10153...... 12523 228...... 13805 10154...... 12525 302...... 12079 10155...... 12527 ELECTRONIC RESEARCH 1002...... 14363 Executive Orders: Proposed Rules: World Wide Web 14017...... 11849 700...... 13494 14018...... 11855 701...... 13494 Full text of the daily Federal Register, CFR and other publications 14019...... 13623 702...... 13498 is located at: www.govinfo.gov. 14020...... 13797 703...... 13494, 13498 Federal Register information and research tools, including Public 14021...... 13803 704...... 13494 Inspection List and electronic text are located at: Administrative Orders: 713...... 13494 www.federalregister.gov. Memorandums: 1026...... 12839 NSPM-16 of February E-mail 7, 2019 (amended 13 CFR FEDREGTOC (Daily Federal Register Table of Contents Electronic by EO 14020)...... 13797 120...... 13149 Notices: Mailing List) is an open e-mail service that provides subscribers 14 CFR with a digital form of the Federal Register Table of Contents. The Notice of March 2, digital form of the Federal Register Table of Contents includes 2021 ...... 12793 1...... 13629 HTML and PDF links to the full text of each document. Notice of March 2, 11...... 13629, 13630 2021 ...... 12795 21...... 13630 To join or leave, go to https://public.govdelivery.com/accounts/ Notice of March 2, 25 ...... 14229, 14231, 14233, USGPOOFR/subscriber/new, enter your email address, then 2021 ...... 12797 14234, 14237 follow the instructions to join, leave, or manage your Notice of March 5, 39 ...... 12086, 12802, 12804, subscription. 2021 ...... 13621 12807, 12809, 13157, 13159, PENS (Public Law Electronic Notification Service) is an e-mail 13162, 13165, 13443, 13445, 5 CFR service that notifies subscribers of recently enacted laws. 13631, 13633, 13637, 13640, 532...... 11857, 12799 To subscribe, go to http://listserv.gsa.gov/archives/publaws-l.html 13805, 13807, 13809, 13811, and select Join or leave the list (or change settings); then follow Proposed Rules: 13814, 13972, 13975, 13982, the instructions. 849...... 13217 13985, 13987, 13989, 14238, 14241, 14366 FEDREGTOC and PENS are mailing lists only. We cannot 6 CFR 43...... 13630 respond to specific inquiries. Ch. I ...... 13971 47...... 13629 Reference questions. Send questions and comments about the 48...... 13629 7 CFR Federal Register system to: [email protected] 71 ...... 11859, 11860, 13168, 983...... 12799 13169, 13171, 13172, 13447, The Federal Register staff cannot interpret specific documents or 13448, 13642, 13644, 13992 regulations. Proposed Rules: 800...... 12119 89...... 13629 984...... 12837 91...... 13629 FEDERAL REGISTER PAGES AND DATE, MARCH 97 ...... 12812, 12815, 12816, 8 CFR 12819 11847–12078...... 1 103...... 14221 107...... 13629, 13630 12079–12256...... 2 106...... 14221 401...... 13448 12257–12514...... 3 212...... 14221 404...... 13448 12515–12798...... 4 213...... 14221 413...... 13448 12799–13148...... 5 214...... 14221 414...... 13448 13149–13442...... 8 245...... 14221 415...... 13448 13443–13622...... 9 248...... 14221 417...... 13448 420...... 13448 13623–13796...... 10 9 CFR 13797–13970...... 11 431...... 13448 Proposed Rules: 433...... 13448 13971–14220...... 12 Ch. I ...... 13221 435...... 13448 14221–14362...... 15 Ch. III ...... 13221 437...... 13448 14363–14524...... 16 149...... 12293 440...... 13448 307...... 12122 450...... 13448 350...... 12122 460...... 13448 352...... 12122 1264...... 14244 354...... 12122 1271...... 14244

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Proposed Rules: 556...... 13181 37 CFR 115...... 11913 25...... 14387 558...... 13181 210...... 12822 176...... 11913 39 ...... 12127, 12294, 12550, 1308...... 11862, 12257 12857, 12862, 13222, 13225, 40 CFR Proposed Rules: 47 CFR 13228, 13229, 13232, 13234, 1308...... 12296 49...... 12260 13237, 13239, 13502, 13505, 52 ...... 11867, 11870, 11872, 0...... 12545 13665, 13828, 13830, 13833, 22 CFR 11873, 11875, 11878, 12092, 1...... 12545 13836, 13838, 13841, 14017, Proposed Rules: 12095, 12107, 12263, 12265, 25...... 11880 14020, 14023, 14281, 14283, 213...... 11905 12270, 12827, 13191, 13655, 27...... 13659 14285, 14289, 14290, 14293 13658, 13816, 13819, 14000, 74...... 13660 71 ...... 12129, 12865, 12866, 24 CFR 14007 Proposed Rules: 12868, 13242, 13244, 13246, 28...... 14370 62...... 12109, 13459 1 ...... 12146, 12312, 12556, 13247, 13249, 13668, 13670, 30...... 14370 63...... 13819 12898 14026, 14293, 14295 87...... 14370 81...... 12107 2...... 13266 73...... 12552 180...... 14370 141...... 12272, 14003 9...... 12399 15...... 13266 15 CFR 3280...... 13645 180 ...... 12829, 13196, 13459 3282...... 13645, 14370 271...... 12834 25...... 13266 740...... 13173 3285...... 13645 282...... 12110 27...... 12146, 13266 742...... 13173 Proposed Rules: 63...... 12312 744 ...... 12529, 13173, 13179 26 CFR 49...... 14392 73 ...... 12161, 12162, 12163, 16 CFR 1 ...... 12821, 13191, 13647, 52 ...... 11913, 11915, 12143, 12556, 12898, 13278, 13516, 13648 12305, 12310, 12554, 12889, 13684, 14401 317...... 12091 Proposed Rules: 13254, 13256, 13260, 13264, 101...... 13266 17 CFR 1...... 12886, 13250 13511, 13514, 13671, 13679, 13843, 14055, 14061, 14297, 48 CFR 201...... 13645 29 CFR 14299, 14392, 14396 275...... 13024 Ch. 1 ...... 13794 780...... 12535 62...... 11916 279...... 13024 4...... 13794 788...... 12535 81...... 12892 52...... 13794 18 CFR 795...... 12535 141...... 13846, 14063 257...... 14066 157...... 12257 4044...... 14280 271...... 12895 49 CFR Proposed Rules: Proposed Rules: 282...... 12145 4...... 13506 103...... 14297 751...... 14398 191...... 12834 5...... 13506 780...... 14027 192...... 12834, 12835 35...... 12132 788...... 14027 42 CFR 209...... 11888 284...... 12132, 12879 791...... 14038 Proposed Rules: 211...... 11888 795...... 14027 51c ...... 13872 389...... 11891 19 CFR 2204...... 13251 Ch. XII...... 13971 43 CFR 4...... 14245 31 CFR Proposed Rules: 12...... 13993 8365...... 14009 571...... 13684 Ch. I ...... 12534 16...... 12537 44 CFR 122...... 14245 27...... 12537 50 CFR 123...... 14245 35...... 13449 64...... 12117 145...... 14245 50...... 12537 Proposed Rules: 17 ...... 11892, 13200, 13465 149...... 14245 206...... 14067 300...... 13475 33 CFR 635 ...... 12291, 12548, 13491 20 CFR 100...... 13998 45 CFR 648...... 13823, 14012 655...... 13995 117...... 12821 1230...... 13822 660...... 13824, 14379 656...... 13995 165 ...... 12539, 12541, 12543, 2554...... 13822 679 ...... 11895, 13215, 13493, 13649, 13651, 13653 Proposed Rules: 14013, 14014, 14015 21 CFR Proposed Rules: 160...... 13683 680...... 11895 510...... 13181 96...... 11913 164...... 13683 Proposed Rules: 516...... 13181 165...... 12887, 14389 17...... 12563 520...... 13181 46 CFR 223...... 13517, 13518 522...... 13181 34 CFR 401...... 14184 226...... 13517, 13518 524...... 13181 Proposed Rules: 404...... 14184 622...... 12163, 12166 526...... 13181 Ch. III...... 12136, 14048, 14374 Proposed Rules: 648...... 12591 529...... 13181 361...... 13511 71...... 11913 660...... 14401

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