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Contents
Agricultural Marketing

Agricultural Marketing Service

RULES
Recordkeeping on Restricted Use Pesticides by Certified Applications; Recission,
20083
2025-08220

PROPOSED RULES
Rescinding National Organic Program:
Market Development for Mushrooms and Pet Food,
20133-20134
2025-08219
Agriculture

Agriculture Department

See
Agricultural Marketing Service

See
Food and Nutrition Service
Antitrust Division

Antitrust Division

NOTICES
Proposed Settlement Agreement, Stipulation, Order, and Judgment, etc.:
United States of America v. XCL Resources Holdings, LLC, Verdun Oil Company II, LLC, and EP Energy LLC,
20190-20193
2025-08226
Consumer Financial Protection

Bureau of Consumer Financial Protection

RULES
Interpretive Rules, Policy Statements, and Advisory Opinions; Withdrawal,
20084-20087
2025-08286
Centers Medicare

Centers for Medicare & Medicaid Services

NOTICES
Agency Information Collection Activities; Proposals, Submissions, and Approvals,
20166-20169
2025-08307
Board

Civil Rights Cold Case Records Review Board

NOTICES
Formal Determination on Records Release,
20145-20146
2025-08287
Civil Rights

Civil Rights Commission

NOTICES
Hearings, Meetings, Proceedings, etc.:
Florida Advisory Committee,
20147
2025-08239
Meetings; Sunshine Act,
20146-20147
2025-08401
Coast Guard

Coast Guard

RULES
Safety Zone:
Atlantic Ocean, Cocoa Beach, FL,
20108-20110
2025-08288

PROPOSED RULES
Special Local Regulation:
Allegheny River Mile Marker 20.5-21.5, Creighton, PA,
20140-20142
2025-08193
Commerce

Commerce Department

See
International Trade Administration

See
National Oceanic and Atmospheric Administration
Comptroller

Comptroller of the Currency

NOTICES
Request for Information:
Community Bank Digitalization,
20212-20214
2025-08280
Defense Department

Defense Department

RULES
Federal Acquisition Regulation:
Federal Acquisition Circular 2025-04; Introduction,
20220
2025-08021
Federal Acquisition Circular 2025-04; Small Entity Compliance Guide,
20224
2025-08024
List of Domestically Nonavailable Articles,
20220-20223
2025-08022
Technical Amendments,
20223-20224
2025-08023
Education Department

Education Department

PROPOSED RULES
Negotiated Rulemaking Committee; Negotiator Nominations and Schedule of Committee Meetings,
20142-20144
2025-08157

NOTICES
Small, Rural School Achievement Program:
Application Deadline for Fiscal Year 2025,
20157-20159
2025-08299
Energy Department

Energy Department

See
Federal Energy Regulatory Commission
Federal Aviation

Federal Aviation Administration

RULES
Airspace Designations and Reporting Points:
Eastern United States,
20093-20094
2025-08202
Northcentral United States,
20091-20097
2025-08229
2025-08230
Airworthiness Directives:
Leonardo S.p.A. Helicopters,
20087-20091
2025-08282
2025-08283

PROPOSED RULES
Airspace Designations and Reporting Points:
Eastern United States,
20136-20138
2025-08203
Ekalaka, MT,
20138-20140
2025-08251

NOTICES
Environmental Assessments; Availability, etc.:
SpaceX Starship/Super Heavy Vehicle Increased Cadence at the SpaceX Boca Chica Launch Site in Cameron County, TX,
20203
2025-08232
Federal Emergency

Federal Emergency Management Agency

NOTICES
Flood Hazard Determinations,
20182-20187
2025-08246
2025-08247
Federal Energy

Federal Energy Regulatory Commission

NOTICES
Application:
City of Aspen, CO,
20165-20166
2025-08293
Authorization for Continued Project Operation:
City of Seattle, WA,
20161
2025-08291
Combined Filings,
20159-20165
2025-08223
2025-08224
2025-08225
2025-08261
2025-08262
Effectiveness of Exempt Wholesale Generator Status:
Peyton Creek Wind Farm II, LLC, Stoneridge Solar, LLC, et al.,
20160
2025-08222
Environmental Assessments; Availability, etc.:
KC Brighton, LLC,
20159
2025-08292
Federal Highway

Federal Highway Administration

NOTICES
Final Federal Agency Action:
Proposed Transportation Project in Utah,
20204
2025-08281
Federal Motor

Federal Motor Carrier Safety Administration

NOTICES
Exemption Application:
Commercial Driver's License; U.S. Custom Harvesters, Inc.,
20206-20207
2025-08235
Hours of Service of Drivers; Northern Clearing, Inc.,
20204-20206
2025-08234
Federal Procurement

Federal Procurement Policy Office

RULES
Federal Acquisition Regulation:
Federal Acquisition Circular 2025-04; Introduction,
20220
2025-08021
Federal Acquisition Circular 2025-04; Small Entity Compliance Guide,
20224
2025-08024
List of Domestically Nonavailable Articles,
20220-20223
2025-08022
Technical Amendments,
20223-20224
2025-08023
Federal Railroad

Federal Railroad Administration

NOTICES
Request for Amendment:
Metro-North Railroad, Positive Train Control Safety Plan and Positive Train Control System,
20207-20208
2025-08260
Federal Retirement

Federal Retirement Thrift Investment Board

PROPOSED RULES
Curing Missed Loan Payments,
20132-20133
2025-08221
Food and Drug

Food and Drug Administration

RULES
Listing of Color Additives Exempt from Certification:
Butterfly Pea Flower Extract,
20101-20104
2025-08248
Calcium Phosphate,
20097-20101
2025-08249
Galdieria Extract Blue,
20104-20108
2025-08250

NOTICES
Patent Extension Regulatory Review Period:
Elrexfio,
20177-20179
2025-08256
Jaypirca,
20175-20177
2025-08254
Lamzede,
20179-20180
2025-08259
Litfulo,
20171-20172
2025-08255
Ngenla,
20172-20174
2025-08257
Skyclarys,
20169-20171
2025-08253
Sunlenca,
20174-20175
2025-08258
Food and Nutrition

Food and Nutrition Service

RULES
Child and Adult Care Food Program:
Rescission of Obsolete Data Collection Requirements,
20083-20084
2025-08160
Foreign Assets

Foreign Assets Control Office

NOTICES
Sanctions Action,
20214-20216
2025-08227
General Services

General Services Administration

RULES
Federal Acquisition Regulation:
Federal Acquisition Circular 2025-04; Introduction,
20220
2025-08021
Federal Acquisition Circular 2025-04; Small Entity Compliance Guide,
20224
2025-08024
List of Domestically Nonavailable Articles,
20220-20223
2025-08022
Technical Amendments,
20223-20224
2025-08023
Health and Human

Health and Human Services Department

See
Centers for Medicare & Medicaid Services

See
Food and Drug Administration

See
National Institutes of Health
Homeland

Homeland Security Department

See
Coast Guard

See
Federal Emergency Management Agency
Indian Affairs

Indian Affairs Bureau

NOTICES
Agency Information Collection Activities; Proposals, Submissions, and Approvals:
Bureau of Indian Affairs Housing Improvement Program,
20189-20190
2025-08277
Loan Guarantee, Insurance, and Interest Subsidy Program,
20187-20188
2025-08279
Tribal Reassumption of Jurisdiction over Child Custody Proceedings,
20188-20189
2025-08278
Interior

Interior Department

See
Indian Affairs Bureau
Internal Revenue

Internal Revenue Service

NOTICES
Agency Information Collection Activities; Proposals, Submissions, and Approvals:
Contributions for Aid of Construction under Section 118(c),
20216
2025-08233
International Trade Adm

International Trade Administration

NOTICES
Sales at Less Than Fair Value; Determinations, Investigations, etc.:
Thermoformed Molded Fiber Products from the People's Republic of China,
20147-20153
2025-08304
Thermoformed Molded Fiber Products from the Socialist Republic of Vietnam,
20153-20156
2025-08305
Justice Department

Justice Department

See
Antitrust Division

See
Parole Commission
Legal

Legal Services Corporation

NOTICES
Meetings; Sunshine Act,
20193
2025-08350
Management

Management and Budget Office

See
Federal Procurement Policy Office
NASA

National Aeronautics and Space Administration

RULES
Federal Acquisition Regulation:
Federal Acquisition Circular 2025-04; Introduction,
20220
2025-08021
Federal Acquisition Circular 2025-04; Small Entity Compliance Guide,
20224
2025-08024
List of Domestically Nonavailable Articles,
20220-20223
2025-08022
Technical Amendments,
20223-20224
2025-08023
National Institute

National Institutes of Health

NOTICES
Hearings, Meetings, Proceedings, etc.:
Center for Scientific Review,
20181-20182
2025-08241
2025-08243
2025-08303
Fogarty International Center,
20180-20181
2025-08242
National Oceanic

National Oceanic and Atmospheric Administration

RULES
2025 Gulf Red Snapper Recreational For-Hire Fishing Season,
20127-20128
2025-08228
Fisheries of the Northeastern United States:
Atlantic Spiny Dogfish Fishery; 2025 Specifications,
20128-20131
2025-08268
Taking or Importing of Marine Mammals:
Lower Columbia River Dredged Material Management Plan, Oregon and Washington,
20110-20127
2025-08231

NOTICES
Endangered and Threatened Species:
Take of Anadromous Fish,
20156-20157
2025-08306
Permits; Applications, Issuances, etc.:
Marine Mammals; File No. 23922,
20156
2025-08284
Nuclear Regulatory

Nuclear Regulatory Commission

NOTICES
Licenses; Exemptions, Applications, Amendments, etc.:
Disa Technologies, Inc.,
20193-20196
2025-08275
Parole

Parole Commission

NOTICES
Meetings; Sunshine Act,
20193
2025-08378
Pipeline

Pipeline and Hazardous Materials Safety Administration

NOTICES
Permits; Applications, Issuances, etc.:
Hazardous Materials,
20208-20212
2025-08271
2025-08272
2025-08273
Postal Regulatory

Postal Regulatory Commission

NOTICES
New Postal Products,
20196-20197
2025-08290
Postal Service

Postal Service

NOTICES
International Product Change:
Priority Mail Express International, Priority Mail International and First-Class Package International Service Agreement,
20197-20198
2025-08302
Presidential Documents

Presidential Documents

PROCLAMATIONS
Special Observances:
National Foster Care Month (Proc. 10933),
20225-20228
2025-08487
Victory Day for World War II (Proc. 10934),
20229-20230
2025-08488
Securities

Securities and Exchange Commission

NOTICES
Agency Information Collection Activities; Proposals, Submissions, and Approvals,
20199-20200
2025-08301
Application:
Adams Street Private Equity Navigator Fund LLC and Adams Street Advisors, LLC,
20200
2025-08323
Morgan Stanley Direct Lending Fund, et al.,
20200-20201
2025-08322
Nomura Alternative Income Fund, et al.,
20198
2025-08274
Varagon Capital Corporation, et al.,
20198-20199
2025-08324
Meetings; Sunshine Act,
20199
2025-08427
Small Business

Small Business Administration

PROPOSED RULES
Hearings, Meetings, Proceedings, etc.:
Tribal Consultation for 8(a) Business Development Program and Mentor-Protege Program Issues and Best Practices,
20134-20135
2025-08294

NOTICES
Agency Information Collection Activities; Proposals, Submissions, and Approvals,
20201
2025-08236
State Department

State Department

NOTICES
Annual Determination and Certification of Shrimp-Harvesting Nations,
20201-20202
2025-08237
Culturally Significant Objects Imported for Exhibition:
Certain Armor Loans from the Kunsthistorisches Museum Wien,
20203
2025-08269
Transportation Department

Transportation Department

See
Federal Aviation Administration

See
Federal Highway Administration

See
Federal Motor Carrier Safety Administration

See
Federal Railroad Administration

See
Pipeline and Hazardous Materials Safety Administration
Treasury

Treasury Department

See
Comptroller of the Currency

See
Foreign Assets Control Office

See
Internal Revenue Service
Veteran Affairs

Veterans Affairs Department

NOTICES
Agency Information Collection Activities; Proposals, Submissions, and Approvals:
Application Request to Add and/or Remove Dependents,
20216-20217
2025-08289

Separate Parts In This Issue

Part II
Defense Department,
20220-20224
2025-08021
2025-08024
2025-08022
2025-08023
General Services Administration,
20220-20224
2025-08021
2025-08024
2025-08022
2025-08023
Management and Budget Office, Federal Procurement Policy Office,
20220-20224
2025-08021
2025-08024
2025-08022
2025-08023
National Aeronautics and Space Administration,
20220-20224
2025-08021
2025-08024
2025-08022
2025-08023

Part III
Presidential Documents,
20225-20230
2025-08487
2025-08488

Reader Aids
Consult the Reader Aids section at the end of this issue for phone numbers, online resources, finding aids, and notice of recently enacted public laws.
To subscribe to the Federal Register Table of Contents electronic mailing list, go to https://public.govdelivery.com/accounts/USGPOOFR/subscriber/new, enter your e-mail address, then follow the instructions to join, leave, or manage your subscription.
90
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Monday, May 12, 2025
Rules and Regulations
DEPARTMENT OF AGRICULTURE
Agricultural Marketing Service
7 CFR Part 110
[Docket No. AMS-AMS-25-0019]
RIN 0581-AE38
Rescission of Recordkeeping on Restricted Use Pesticides by Certified Applications

AGENCY:
Agricultural Marketing Service (AMS), U.S. Department of Agriculture.

ACTION:
Final rule.

SUMMARY:
This action rescinds regulations pertaining to Recordkeeping on Restricted Use Pesticides by Certified Applicators; Surveys and Reports.

DATES:
The final rule is effective July 11, 2025.

FOR FURTHER INFORMATION CONTACT:
Erin Morris, Associate Administrator, AMS, USDA, Room 2055-S, 1400 Independence Ave. SW, Washington, DC 20250; Telephone (202) 690-4024, or Email erin.morris@usda.gov.

SUPPLEMENTARY INFORMATION:
The United States Department of Agriculture's (USDA) regulations governing Recordkeeping on Restricted Use Pesticides by Certified Applicators; Surveys and Reports are contained in part 110 of title 7 of the Code of Federal Regulations (CFR). These regulations set forth the requirements for recordkeeping on restricted use pesticides by all certified private and commercial applicators. These regulations require the Secretary of Agriculture, in consultation with the Administrator of the Environmental Protection Agency (EPA), to ensure certified applicators of restricted use pesticides (described under 7 U.S.C. 136a(d)(1)(C)) maintain records comparable to records maintained by commercial applicators of pesticides in each State. Upon reviewing these regulations, USDA has determined that they should be rescinded due to their obsolescence.
The record-keeping program was defunded and closed on September 30, 2012, when it was determined that the Federal funding was insufficient to cover the costs of all State cooperators. Twenty-three State programs have since come to operate their own programs and (1) have implemented procedures to inspect certified applicators when complaints are filed; or (2) they combine pesticide recordkeeping inspections with other State and Federal inspections during one visit to a certified private pesticide applicator. These State programs produce and distribute their own educational outreach materials and information.
Other State programs that operated under the Federal regulations and were no longer funded discontinued surveillance or random inspections of certified private pesticide applicators and no longer provided educational outreach and materials. Many of these States have continued to conduct pesticide recordkeeping inspections when a complaint is registered against a certified applicator in order to support State compliance actions.
Furthermore, upon closure of the program, the EPA incorporated training on many of the recordkeeping and reporting requirements into Worker Protection Standards, which apply to many certified private pesticide applicator operations.
USDA has determined that each of these reasons, independently and alone, justifies rescission of the Recordkeeping on Restricted Use Pesticides by Certified Applicators; Surveys and Reports regulations. Regardless of the benefits of the regulations, USDA must not maintain regulations that are obsolete. USDA has determined that there is no reliance interest in an obsolete regulation. Moreover, regardless of the lawfulness, USDA has no interest in maintaining a rule that is obsolete.
To the extent there is any uncertainty about the costs and benefits of the Recordkeeping on Restricted Use Pesticides by Certified Applicators; Surveys and Reports regulations, it is the policy of USDA to err on the side of deregulation. USDA's limited resources should be focused on fairly and rationally enforcing a discrete and manageable number of regulations. The regulations in Recordkeeping on Restricted Use Pesticides by Certified Applicators; Surveys and Reports are not a priority.

List of Subjects in 7 CFR Part 110
Administrative practice and procedure, Agricultural commodities, Intergovernmental relations, Penalties, Pesticides and pests, Reporting and recordkeeping requirements.
Under the authority of 7 U.S.C. 136a(d)(1)(c), 136i-1, and 450; 7 CFR 2.17, 2.50; and for the reasons set forth in the preamble, AMS amends 7 CFR subtitle B chapter 1 as follows:

PART 110—[REMOVED]
1. Remove part 110.
Bruce Summers,

Administrator, Agricultural Marketing Service.
DEPARTMENT OF AGRICULTURE
Food and Nutrition Service
7 CFR Part 226
[Docket No. FNS-2025-0005]
RIN 0584-AF15
Child and Adult Care Food Program: Rescission of Obsolete Data Collection Requirements

AGENCY:
Food and Nutrition Service (FNS), Department of Agriculture (USDA).

ACTION:
Final rule.

SUMMARY:
This rule rescinds an obsolete data collection requirement in regulations regarding the Child and Adult Care Food Program.

DATES:
The final rule is effective July 11, 2025.

FOR FURTHER INFORMATION CONTACT:
James C. Miller, Administrator, Food and Nutrition Service, at (703) 305-2060, or James.Miller@usda.gov with a subject line of “RIN 0584-AF15”.

SUPPLEMENTARY INFORMATION:
USDA's regulations governing data collection related to organizations are contained in § 226.25(g) of title 7 of the Code of Federal Regulations. These regulations include an obsolete requirement for State agencies administering the Child and Adult Care Food Program (CACFP) to collect and report data related to participating institutions in each of Federal fiscal years 2006 through 2009.
Upon reviewing these regulations, USDA has determined that they should be rescinded. This regulation was established on May 2, 2007, under the final rule “Data Collection Related to the Participation of Faith-Based and Community Organizations” (72 FR 24179). The regulation required mandatory collection and reporting activities to cease in 2010. USDA does not intend to resume these requirements because implementation of the directives mandated by the underlying executive orders is complete. These requirements are obsolete and must be removed from Federal regulations. This rulemaking does not impact other data collection requirements outside of those found in current 7 CFR 226.25(g).
USDA has determined that this reason, independently and alone, justifies rescission of the 7 CFR 226.25(g) regulations. Regardless of the benefits of the rule, USDA must not maintain regulations that are unlawful. USDA has determined that there is no reliance interest in an unlawful regulation. See Dep't of Homeland Sec. v. Regents of the Univ. of California, 591 U.S. 1, 32 (2020). Moreover, regardless of lawfulness, USDA has no interest in maintaining a rule that is outdated.
To the extent there is any uncertainty about the costs and benefits of the 7 CFR 226.25(g) regulations, it is the policy of USDA to err on the side of deregulation. USDA's limited resources should be focused on fairly and rationally enforcing a discrete and manageable number of regulations. The regulations at 7 CFR 226.25(g) are not a priority.

Procedural Matters

Executive Orders 12866 and 13563
Under Executive Order 12866, as amended by Executive Orders 14215 and 13563, agencies must assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, select regulatory approaches that maximize net benefits. The Office of Management and Budget's (OMB) Office of Information and Regulatory Affairs has determined that this regulatory action is not significant and, therefore, is not subject to OMB review.

Regulatory Flexibility Act
Under the Regulatory Flexibility Act (5 U.S.C. 601-612) (as amended by the Small Business Regulatory Enforcement Fairness Act of 1996; 5 U.S.C. 601 et seq. ), agencies must prepare and make available for public comment a regulatory flexibility analysis that describes the effect of the rule on small entities ( i.e., small businesses, small organizations, and small government jurisdictions). FNS has concluded and hereby certifies that this rule will not have a significant economic impact on a substantial number of small entities.

Unfunded Mandates Reform Act
This rule does not contain Federal mandates (under the regulatory provisions of Title II of the Unfunded Mandates Reform Act (UMRA)) for State, local, and Tribal governments, or the private sector of $100 million or more in any one year. Thus, the rule is not subject to the requirements of sections 202 and 205 of the UMRA.

Executive Order 13175
Executive Order 13175 requires Federal agencies to consult and coordinate with Tribes on a government-to-government basis on policies that have Tribal implications, including regulations, legislative comments or proposed legislation, and other policy statements or actions that have substantial direct effects on one or more Indian Tribes, on the relationship between the Federal Government and Indian Tribes, or on the distribution of power and responsibilities between the Federal Government and Indian Tribes. As this rule is purely deregulatory, FNS has assessed the impact of this rule on Indian tribes and determined that this rule would not have Tribal implications that require consultation under Executive Order 13175.

Paperwork Reduction Act
In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520), an agency may not conduct or sponsor, and a person is not required to respond to, a collection of information, unless the collection displays a currently valid OMB control number. This rule is deregulatory and so would not impose any additional information collection requirements; rather, it would reduce future collection requirements by removing reporting burdens.

E-Government Act Compliance
The Department is committed to complying with the E-Government Act, 2002 to promote the use of the internet and other information technologies to provide increased opportunities for citizen access to Government information and services, and for other purposes.

Executive Order 13132; Federalism Summary Impact Statement
The rule is deregulatory and has little effect on States and local governments, so FNS anticipates that this rule will not have implications for federalism. Therefore, under section 6(b) of the Executive order, a federalism summary is not required.

List of Subjects in 7 CFR Part 226
Day care, Food assistance programs, Grant programs, Grant programs—health, Grant programs—social programs, Infants and children, Intergovernmental relations, Reporting and recordkeeping requirements.
Accordingly, 7 CFR part 226 is amended as follows:

PART 226—CHILD AND ADULT CARE FOOD PROGRAM
1. The authority citation for part 226 continues to read as follows:

Authority:
Secs. 9, 11, 14, 16, and 17, Richard B. Russell National School Lunch Act, as amended (42 U.S.C. 1758, 1759a, 1762a, 1765 and 1766).
§ 226.25
[Amended]
2. In § 226.25:
a. Remove paragraph (g);
b. Redesignate paragraphs (h) through (j) as paragraphs (g) through (i); and
c. In newly redesignated paragraphs (i)(2) and (5), remove “(j)(1)” and add “(i)(1)” in its place.
James C. Miller,

Administrator.
CONSUMER FINANCIAL PROTECTION BUREAU
12 CFR Chapter X
Interpretive Rules, Policy Statements, and Advisory Opinions; Withdrawal

AGENCY:
Consumer Financial Protection Bureau.

ACTION:
Withdrawal of Bureau guidance, interpretive rules, policy statements, and advisory opinions.

SUMMARY:
The Consumer Financial Protection Bureau (CFPB or Bureau) is withdrawing many guidance documents issued since the CFPB assumed its functions in 2011.

DATES:
The withdrawals are applicable as of May 12, 2025.

FOR FURTHER INFORMATION CONTACT:
George Karithanom, Regulatory Implementation and Guidance Program Analyst, Office of Regulations, at 202-435-7700 or https://reginquiries.consumerfinance.gov/. If you require this document in an alternative electronic format, please contact CFPB_Accessibility@cfpb.gov .

SUPPLEMENTARY INFORMATION:

I. Background
Americans deserve an open and fair regulatory process that imposes new obligations on the public only when consistent with applicable law and after an agency follows appropriate procedures. In Executive Order 13891, President Trump directed that agencies should not use guidance documents to attempt to create new rights or obligations binding on persons or entities outside of the Federal Government. Instead, that Executive order provided that agencies should impose legally binding requirements on the public only through regulations and on parties on a case-by-case basis through adjudications, and only after appropriate process, except as authorized by law or as incorporated into a contract. Although that Executive order was rescinded by the Biden Administration, the principles it expressed are required by laws such as the Administrative Procedure Act and are no less salient today. That is why I issued a memorandum on April 11, 2025, prohibiting improper use of guidance by the Bureau.
The CFPB has issued non-binding policy guidance in myriad forms over its history. This guidance has taken the form of guidance documents, interpretive rules, advisory opinions, and policy statements. In many instances, this guidance has adopted interpretations that are inconsistent with the statutory text and impose compliance burdens on regulated parties outside of the strictures of notice-and-comment rulemaking. ^1 But even where the guidance might advance a permissible interpretation of the relevant statute or regulation, or afforded the public an opportunity to weigh in, it is the Bureau's current policy to avoid issuing guidance except where necessary and where compliance burdens would be reduced rather than increased.
^1 For example, the Bureau's 2023 advisory opinion relating to consumer requests for account information suggests that “requiring a consumer to pay a fee” for such a request “is likely to unreasonably impede consumers' ability to exercise the right granted by section 1034(c) [of the Consumer Financial Protection Act], and thus to violate the provision.” Consumer Information Requests to Large Banks and Credit Unions, 88 FR 71279 (Oct. 16, 2023). Yet section 1034(c) is silent as to fees and merely requires large banks and credit unions to “comply with a consumer request for information” in “a timely manner.” See 12 U.S.C. 5534(c)(1). And, just recently, the Bureau rescinded a 2020 advisory opinion because “its legal analysis [wa]s significantly flawed in numerous respects.” See Truth in Lending (Regulation Z); Consumer Credit Offered to Borrowers in Advance of Expected Receipt of Compensation for Work, 90 FR 3622 (Jan. 15, 2025).
On April 11, 2025, I instructed Bureau components to identify and review all guidance material previously produced and flag for retention guidance documents that conform to the principles set out in my separate April 11 memorandum on guidance. Bureau leadership has conducted a review of guidance documents and has determined to withdraw all guidance materials identified in section III below. Such withdrawal is not necessarily final. The Bureau intends to continue reviewing all guidance documents to determine whether they should ultimately be retained. However, the Bureau has determined that the guidance identified in section III should not be enforced or otherwise relied upon by the Bureau while this review is ongoing. Accordingly, the Bureau is hereby withdrawing all of the guidance materials set forth in section III below.

II. Analysis
The Bureau is withdrawing the guidance materials identified in section III for three independent reasons.
First, the Bureau is committed to issuing guidance only where that guidance is necessary and would reduce compliance burdens rather than increase them. Historically, the Bureau has released guidance without adequate regard for whether it would increase or decrease compliance burdens and costs. Our policy has changed. To effectuate the Bureau's new policy preference, the Bureau is withdrawing all guidance documents to afford staff an opportunity to review and consider (1) whether the guidance is statutorily prescribed, (2) whether the interpretation therein is consistent with the relevant statute or regulation, and (3) whether it imposes or decreases compliance burdens. The alternative—leaving guidance documents in place while the Bureau reviews each interpretation to determine its net effect on compliance burdens—risks imposing unnecessary and illegal compliance burdens in the interim. The Bureau rejects that alternative. While some guidance might be reissued in the future, the Bureau does not intend to prioritize the enforcement of such guidance against parties that do not conform to the guidance during the pendency of any withdrawal.
Second, the Bureau is reducing its enforcement activities in light of President Trump's directives to deregulate and streamline bureaucracy, and therefore has no pressing need for interpretive guidance to remain in effect. ^2 Many of the Bureau's enforcement responsibilities overlap with or are duplicative of other Federal and State regulators, including the Federal Trade Commission, the Department of Justice, and financial regulators. ^3 To reduce this overlap and mitigate the unnecessary compliance burdens posed by duplicative investigative and enforcement authority, the Bureau is reducing its own enforcement to only those areas statutorily required. Withdrawing guidance that might have guided or animated all of the Bureau's enforcement efforts therefore should not adversely affect regulated parties.
^2 E.O. 14219 of February 19, 2025, Ensuring Lawful Governance and Implementing the President's “Department of Government Efficiency” Deregulatory Initiative.
^3 The states maintain jurisdiction over many institutions also within the Bureau's regulatory purview. 12 U.S.C. 5551 et seq. State attorneys general may even bring actions to enforce the Dodd-Frank Wall Street Reform and Consumer Protection Act, see 12 U.S.C. 5552(a). Similarly, the Bureau's jurisdiction over depository institutions is shared by the Federal Deposit Insurance Corporation, the Office of the Comptroller of Currency, and the Federal Reserve Board of Governors. And, like the Bureau, the Federal Trade Commission maintains broad authority to regulate unfair and deceptive practices. Compare 12 U.S.C. 5551, with 15 U.S.C. 45.
Third, the Bureau does not believe that any reliance interests compel retention of guidance for several reasons. As a threshold matter, parties understand that guidance is generally non-binding and generally does not create substantive rights. In addition, as explained above, the Bureau will deprioritize enforcement against regulated parties whose conduct does not conform to the guidance during the pendency of any withdrawal. Finally, to the extent guidance materials or portions thereof go beyond the relevant statute or regulation, they are unlawful, undermining any reliance interest in retaining that guidance. Where guidance is not per se unlawful, the Bureau nonetheless determines that guidance should be withdrawn and that it should be reissued only if the guidance is necessary and only if it reduces compliance burdens. The Bureau determines that the benefits of this policy outweigh the cost to any purported reliance interests.

III. Guidance Withdrawn
Through this notification, the Bureau is hereby withdrawing the following guidance materials:

Policy Statements
1. Policy Statement on No Action Letters, 90 FR 1970 (Jan. 10, 2025).
2. Policy Statement on Compliance Assistance Sandbox Approvals, 90 FR 1974 (Jan. 10, 2025).
3. Statement of Policy Regarding Prohibition on Abusive Acts or Practices, 88 FR 21883 (Apr. 12, 2023).
4. Statement on Enforcement and Supervisory Practices Relating to the Small Business Lending Rule Under the Equal Credit Opportunity Act and Regulation B, 88 FR 34833 (May 31, 2023).
5. Statement on Supervisory and Enforcement Practices Regarding the Remittance Rule in Light of the COVID-19 Pandemic (Apr. 10, 2020), https://files.consumerfinance.gov/f/documents/cfpb_policy-statement_remittances-covid-19_2020-04.pdf.
6. Disclosure of Consumer Complaint Narrative Data, 80 FR 15572 (Mar. 24, 2015).
7. Disclosure of Consumer Complaint Data, 78 FR 21218 (Apr. 10, 2013).
8. Disclosure of Certain Credit Card Complaint Data, 77 FR 37558 (June 22, 2012).

Interpretive Rules
1. Use of Digital User Accounts to Access Buy Now, Pay Later Loans, 89 FR 47068 (May 31, 2024).
2. Limited Applicability of Consumer Financial Protection Act's `Time or Space' Exception to Digital Marketers, 87 FR 50556 (Aug. 17, 2022).
3. The Fair Credit Reporting Act's Limited Preemption of State Laws, 87 FR 41042 (July 11, 2022).
4. Authority of States to Enforce the Consumer Financial Protection Act of 2010, 87 FR 31940 (May 26, 2022).
5. Examinations for Risks to Active-Duty Servicemembers and Their Covered Dependents, 86 FR 32723 (June 23, 2021).
6. Equal Credit Opportunity (Regulation B); Discrimination on the Bases of Sexual Orientation and Gender Identity, 86 FR 14363 (Mar. 16, 2021).
7. Bulletin clarifying mortgage lending rules to assist surviving family members (July 8, 2014), https://www.consumerfinance.gov/compliance/supervisory-guidance/bulletin-mortgage-lending-rules-surviving-family-members/.

Advisory Opinions
1. Truth in Lending (Regulation Z); Consumer Credit Offered to Borrowers in Advance of Expected Receipt of Compensation for Work, 90 FR 3622 (Jan. 15, 2025).
2. Fair Credit Reporting; File Disclosure, 89 FR 4167 (Jan. 23, 2024).
3. Debt Collection Practices (Regulation F); Deceptive and Unfair Collection of Medical Debt, 89 FR 80715 (Oct. 4, 2024).
4. Fair Credit Reporting; Background Screening, 89 FR 4171 (Jan. 23, 2024).
5. Truth in Lending (Regulation Z); Consumer Protections for Home Sales Financed Under Contracts for Deed, 89 FR 68086 (Aug. 23, 2024).
6. Consumer Information Requests to Large Banks and Credit Unions, 88 FR 71279 (Oct. 16, 2023).
7. Fair Debt Collection Practices Act (Regulation F); Time-Barred Debt, 88 FR 26475 (May 1, 2023).
8. Fair Credit Reporting; Permissible Purposes for Furnishing, Using, and Obtaining Consumer Reports, 87 FR 41243 (July 12, 2022).
9. Debt Collection Practices (Regulation F); Pay-to-Pay Fees, 87 FR 39733 (July 5, 2022).
10. Equal Credit Opportunity (Regulation B); Revocations or Unfavorable Changes to the Terms of Existing Credit Arrangements, 87 FR 30097 (May 18, 2022).
11. Fair Credit Reporting; Name-Only Matching Procedures, 86 FR 62468 (Nov. 10, 2021).
12. Truth in Lending (Regulation Z); Earned Wage Access Programs, 85 FR 79404 (Dec. 10, 2020).
13. Truth in Lending (Regulation Z); Private Education Loans, 85 FR 79400 (Dec. 10, 2020).

Other Guidance
1. Consumer Financial Protection Circular 2024-06: Background Dossiers and Algorithmic Scores for Hiring, Promotion, and Other Employment Decisions, 89 FR 88875 (Nov. 12, 2024).
2. Consumer Financial Protection Circular 2024-05: Improper Overdraft Opt-in Practices, 89 FR 8007 (Oct. 2, 2024).
3. Consumer Financial Protection Circular 2024-04: Whistleblower protections under CFPA Section 1057, 89 FR 65170 (Aug. 9, 2024).
4. Consumer Financial Protection Circular 2024-03: Unlawful and unenforceable contract terms and conditions, 89 FR 51955 (June 21, 2024).
5. Consumer Financial Protection Circular 2024-02: Deceptive marketing practices about the speed or cost of sending a remittance transfer, 89 FR 27357 (Apr. 17, 2024).
6. Consumer Financial Protection Circular 2024-01: Preferencing and steering practices by digital intermediaries for consumer financial products or services, 89 FR 17706 (Mar. 12, 2024).
7. Consumer Financial Protection Circular 2023-03: Adverse action notification requirements and the proper use of the CFPB's sample forms provided in Regulation B, 89 FR 27361 (Apr. 17, 2024).
8. Consumer Financial Protection Circular 2023-02: Reopening deposit accounts that consumers previously closed, 88 FR 33545 (May 24, 2023).
9. Consumer Financial Protection Circular 2023-01: Unlawful negative option marketing practices, 88 FR 5727 (Jan. 30, 2023).
10. Consumer Financial Protection Circular 2022-07: Reasonable investigation of consumer reporting disputes, 87 FR 71507 (Nov. 23, 2022).
11. Consumer Financial Protection Circular 2022-06: Unanticipated overdraft fee assessment practices, 87 FR 66935 (Nov. 7, 2022).
12. Consumer Financial Protection Circular 2022-05: Debt collection and consumer reporting practices involving invalid nursing home debts, 87 FR 57375 (Sept. 20, 2022).
13. Consumer Financial Protection Circular 2022-04: Insufficient data protection or security for sensitive consumer information, 87 FR 54346 (Sept. 6, 2022).
14. Consumer Financial Protection Circular 2022-03: Adverse action notification requirements in connection with credit decisions based on complex algorithms, (87 FR 35864 (June 14, 2022).
15. Consumer Financial Protection Circular 2022-02: Deceptive representations involving the FDIC's name or logo or deposit insurance, 87 FR 35866 (June 14, 2022).
16. Consumer Financial Protection Circular 2022-01: System of Consumer Financial Protection Circulars to agencies enforcing federal consumer financial law, 87 FR 35868 (June 14, 2022).
17. Bulletin 2023-01: Unfair Billing and Collection Practices After Bankruptcy Discharges of Certain Student Loan Debts, 88 FR 17366 (Mar. 23, 2023).
18. Bulletin 2022-06: Unfair Returned Deposited Item Fee Assessment Practices, 87 FR 66940 (Nov. 7, 2022).
19. Bulletin 2022-05: Unfair and Deceptive Acts or Practices That Impede Consumer Reviews, 87 FR 17143 (Mar. 28, 2022).
20. Bulletin 2022-04: Mitigating Harm from Repossession of Automobiles, 87 FR 11951 (Mar. 3, 2022).
21. Bulletin 2022-03: Servicer Responsibilities in Public Service Loan Forgiveness Communications, 87 FR 11286 (Mar. 1, 2022).
22. Bulletin 2022-01: Medical Debt Collection and Consumer Reporting Requirements in Connection with the No Surprises Act, 87 FR 3025 (Jan. 20, 2022).
23. Enforcement Compliance Bulletin 2021-03: Consumer Reporting of Rental Information, 86 FR 35595 (July 7, 2021).
24. Bulletin 2021-02: Supervision and Enforcement Priorities Regarding Housing Insecurity, 86 FR 17897 (Apr. 7, 2021).
25. Policy Guidance on Supervisory and Enforcement Priorities Regarding Early Compliance with the 2016 Amendments to the 2013 Mortgage Rules Under the Real Estate Settlement Procedures Act (Regulation X) and the Truth in Lending Act (Regulation Z), 82 FR 29713 (June 30, 2017).
26. Bulletin 2016-03: Detecting and Preventing Consumer Harm from Production Incentives, 82 FR 5541 (Jan. 18, 2017).
27. Bulletin 2015-07 re: in-person collection of consumer debt (Dec. 16, 2015), https://www.consumerfinance.gov/compliance/supervisory-guidance/bulletin-personal-collection-consumer-debt/.
28. Bulletin 2015-02 re: Section 8 housing choice voucher homeownership program (May 11, 2015), https://www.consumerfinance.gov/compliance/supervisory-guidance/bulletin-section-8-housing-choice-voucher-homeownership-program/.
29. Bulletin 2014-02 re: marketing of credit card promotional APR offers (Sept. 3, 2014), https://www.consumerfinance.gov/compliance/supervisory-guidance/bulletin-marketing-credit-card-promotional-apr-offers/.
30. Bulletin 2014-01 re: FCRA requirement that furnishers conduct investigations (Feb. 27, 2014), https://www.consumerfinance.gov/compliance/supervisory-guidance/bulletin-fcra-requirement-furnishers-conduct-investigations/.
31. Bulletin 2013-09 re: the FCRA's requirement to investigate disputes and review “all relevant” information (Sept. 4, 2013), https://www.consumerfinance.gov/compliance/supervisory-guidance/bulletin-fcra-requirement-investigate-disputes/.
32. Bulletin 2013-07 re: prohibition of unfair, deceptive, or abusive acts or practices in the collection of consumer debts (July 10, 2013), https://www.consumerfinance.gov/compliance/supervisory-guidance/bulletin-prohibition-practices-collection-consumer-debts/.
33. Bulletin 2013-01 re: indirect auto lending and compliance with the Equal Credit Opportunity Act (Mar. 21, 2013), https://www.consumerfinance.gov/compliance/supervisory-guidance/bulletin-indirect-auto-lending-compliance/.
34. Bulletin 2012-09 re: FCRA's streamlined process requirement for consumers to obtain free annual reports (Nov. 29, 2012), https://www.consumerfinance.gov/compliance/supervisory-guidance/bulletin-fcra-process-requirement-consumers/.
35. Bulletin 2012-08 re: implementation of the remittance rule (Regulation E, Subpart B) (Nov. 27, 2012), https://www.consumerfinance.gov/compliance/supervisory-guidance/bulletin-implementation-remittance-rule/.
36. Bulletin 2012-06 re: marketing of credit card add-on products (June 27, 2011), https://www.consumerfinance.gov/compliance/supervisory-guidance/bulletin-marketing-credit-card-add-on-products/.
37. Bulletin 2012-04 re: lending discrimination.
38. Bulletin 2012-02 re: the payment of compensation to loan originators (April 2, 2012), https://www.consumerfinance.gov/compliance/supervisory-guidance/bulletin-payment-compensation-loan-originators/.
39. Bulletin 11-2 re: the Interstate Land Sales Full Disclosure Act, https://files.consumerfinance.gov/f/201107_CFPB_Guidance_ILS-Communications-With-CFPB-Update-July-202012.pdf/.
Russell T. Vought,

Acting Director, Consumer Financial Protection Bureau.
DEPARTMENT OF TRANSPORTATION
Federal Aviation Administration
14 CFR Part 39
[Docket No. FAA-2025-0019; Project Identifier MCAI-2023-01218-R; Amendment 39-23027; AD 2025-09-06]
RIN 2120-AA64
Airworthiness Directives; Leonardo S.p.A. Helicopters

AGENCY:
Federal Aviation Administration (FAA), DOT.

ACTION:
Final rule.

SUMMARY:
The FAA is adopting a new airworthiness directive (AD) for all Leonardo S.p.A. Model A119 and AW119 MKII helicopters. This AD was prompted by a report of an electrical failure of the starter-generator, due to a rupture of the drive shaft, which resulted in a partial loss of battery power. This AD requires installing a battery discharge detector and revising the existing Rotorcraft Flight Manual (RFM) for the helicopter. These actions are specified in a European Union Aviation Safety Agency (EASA) AD, which is incorporated by reference. The FAA is issuing this AD to address the unsafe condition on these products.

DATES:
This AD is effective June 16, 2025.
The Director of the Federal Register approved the incorporation by reference of a certain publication listed in this AD as of June 16, 2025.

ADDRESSES:
AD Docket: You may examine the AD docket at regulations.gov under Docket No. FAA-2025-0019; or in person at Docket Operations between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains this final rule, the mandatory continuing airworthiness information (MCAI), any comments received, and other information. The address for Docket Operations is U.S. Department of Transportation, Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE, Washington, DC 20590.
Material Incorporated by Reference:
• For EASA material identified in this AD, contact EASA, Konrad-Adenauer-Ufer 3, 50668 Cologne, Germany; phone: +49 221 8999 000; email: ADs@easa.europa.eu; website: easa.europa.eu. You may find this material on the EASA website at ad.easa.europa.eu.
• You may view this material at the FAA, at the FAA, Office of the Regional Counsel, Southwest Region, 10101 Hillwood Parkway, Room 6N-321, Fort Worth, TX 76177. For information on the availability of this material at the FAA, call (817) 222-5110. It is also available at regulations.gov under Docket No. FAA-2025-0019.

FOR FURTHER INFORMATION CONTACT:
William McCully, Aviation Safety Engineer, FAA, 1600 Stewart Avenue, Suite 410, Westbury, NY 11590; phone: (404) 474-5548; email: william.mccully@faa.gov .

SUPPLEMENTARY INFORMATION:

Background
The FAA issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to Leonardo S.p.A. Model A119 and AW119 MKII helicopters. The NPRM was published in the Federal Register on February 6, 2025 (90 FR 9069). The NPRM was prompted by EASA AD 2023-0210, dated November 27, 2023 (EASA AD 2023-0210) (also referred to as “the MCAI”), issued by EASA, which is the Technical Agent for the Member States of the European Union. The MCAI states an electrical failure of a starter-generator occurred, which was caused by a rupture of the drive shaft. The MCAI further states that this failure was not detected by the generator control unit, which resulted in a partial loss of battery power.
In the NPRM, the FAA proposed to require installing a battery discharge detector and revising the existing RFM for the helicopter. The owner/operator (pilot) holding at least a private pilot certificate may perform the revision to the existing RFM for the helicopter and must enter compliance with the applicable paragraphs of this AD into the helicopter maintenance records in accordance with 14 CFR 43.9(a) and 91.417(a)(2)(v). The pilot may perform this action because it only involves revising the existing RFM by inserting pages, which is not considered a maintenance action.
The FAA is issuing this AD to address the unsafe condition on these products.
You may examine the MCAI in the AD docket at regulations.gov under Docket No. FAA-2025-0019.

Discussion of Final Airworthiness Directive

Comments
The FAA received comments from two individual commenters. Both commenters supported the NPRM without change.

Conclusion
These products have been approved by the civil aviation authority of another country and are approved for operation in the United States. Pursuant to the FAA's bilateral agreement with this State of Design Authority, that authority has notified the FAA of the unsafe condition described in the MCAI referenced above. The FAA reviewed the relevant data, considered any comments received, and determined that air safety requires adopting this AD as proposed. Accordingly, the FAA is issuing this AD to address the unsafe condition on these products. This AD is adopted as proposed in the NPRM.

Material Incorporated by Reference Under 1 CFR Part 51
EASA AD 2023-0210 requires installing a battery discharge detector and amending the existing RFM for the helicopter by incorporating the RFM revision identified within, as applicable by helicopter model and serial number. The RFM revision includes revising the Emergency and Malfunction Procedures by updating “Failure of the generator and d.c. bus” information and adding “Battery discharging” information.
This material is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the ADDRESSES section.

Differences Between This AD and the MCAI
For Model AW119 MKII helicopters modified by STC SR03280NY, the material referenced in EASA AD 2023-0210 specifies contacting the STC holder for instructions, whereas this AD requires installing a battery discharge detector in accordance with a method approved by the FAA.
The MCAI requires operators to “inform all flight crew” of the revisions to the RFM, and thereafter to “operate the helicopter accordingly.” However, this AD does not require those actions as those actions are already required by FAA regulations. FAA regulations require operators furnish to pilots any changes to the RFM (for example, 14 CFR 135.21) and to ensure the pilots are familiar with the RFM (for example, 14 CFR 91.505). As with any other flight crew training requirement, training on the updated RFM content is tracked by the operators and recorded in each pilot's training record, which is available for the FAA to review. FAA regulations also require pilots to follow the procedures in the existing RFM including all updates. Therefore, including a requirement in this AD to inform the flight crew and operate the helicopter according to the revised RFM would be redundant and unnecessary.
Further, compliance with such requirements in an AD is impracticable to demonstrate or track on an ongoing basis; therefore, a requirement to operate the aircraft in such a manner is unenforceable. Nonetheless, the FAA recommends that flight crews of the helicopters listed in the applicability operate in accordance with the revised emergency procedures required by this AD.

Costs of Compliance
The FAA estimates that this AD affects 192 helicopters of U.S. registry. Labor costs are estimated at $85 per hour. Based on these numbers, the FAA estimates the following costs to comply with this AD.
For Model AW119 MKII helicopters modified by STC SR03280NY, the FAA has no data to provide cost estimates for installing a battery discharge detector. For all other helicopters, installing a battery discharge detector takes up to 10 hours with a parts cost of $1,772 for an estimated cost of $2,622 per helicopter and $503,424 for the U.S. fleet. Revising the existing RFM for the helicopter takes 1 hour for an estimated cost of $85 per helicopter and $16,320 for the U.S. fleet.
The FAA has included all known costs in its cost estimate. According to the manufacturer, however, some of the costs of this AD may be covered under warranty, thereby reducing the cost impact on affected operators.

Authority for This Rulemaking
Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. Subtitle VII: Aviation Programs, describes in more detail the scope of the Agency's authority.
The FAA is issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section 44701: General requirements. Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.

Regulatory Findings
This AD will not have federalism implications under Executive Order 13132. This AD will not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.
For the reasons discussed above, I certify that this AD:
(1) Is not a “significant regulatory action” under Executive Order 12866,
(2) Will not affect intrastate aviation in Alaska, and
(3) Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39
Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.

The Amendment
Accordingly, under the authority delegated to me by the Administrator, the FAA amends 14 CFR part 39 as follows:

PART 39—AIRWORTHINESS DIRECTIVES
1. The authority citation for part 39 continues to read as follows:

Authority:
49 U.S.C. 106(g), 40113, 44701.
§ 39.13
[Amended]
2. The FAA amends § 39.13 by adding the following new airworthiness directive:
2025-09-06 Leonardo S.p.A.: Amendment 39-23027; Docket No. FAA-2025-0019; Project Identifier MCAI-2023-01218-R.

(a) Effective Date
This airworthiness directive (AD) is effective June 16, 2025.

(b) Affected ADs
None.

(c) Applicability
This AD applies to Leonardo S.p.A. Model A119 and AW119 MKII helicopters, certificated in any category.

(d) Subject
Joint Aircraft Service Component (JASC) Code 2432, Battery/charger system.

(e) Unsafe Condition
This AD was prompted by a report of an electrical failure of the starter-generator, due to a rupture of the drive shaft, which resulted in a partial loss of battery power. The FAA is issuing this AD to prevent loss of battery power. The unsafe condition, if not addressed, could lead to complete loss of electrical power, and subsequent loss control of the helicopter.

(f) Compliance
Comply with this AD within the compliance times specified, unless already done.

(g) Requirements
(1) Except as specified in paragraphs (h) and (i) of this AD: Comply with all required actions and compliance times specified in, and in accordance with, European Union Aviation Safety Agency (EASA) AD 2023-0210, dated November 27, 2023 (EASA AD 2023-0210).
(2) The owner/operator (pilot) holding at least a private pilot certificate may revise the existing Rotorcraft Flight Manual for the helicopter and must enter compliance with this requirement into the helicopter maintenance records in accordance with 14 CFR 43.9(a) and 14 CFR 91.417(a)(2)(v). The record must be maintained as required by 14 CFR 91.417, 121.380, or 135.439.

(h) Exceptions to EASA AD 2023-0210
(1) Where EASA AD 2023-0210 refers to its effective date, this AD requires using the effective date of this AD.
(2) Where the material referenced in EASA AD 2023-0210 specifies contacting the STC holder for Model AW119 MKII helicopters modified by STC SR03280NY, this AD requires installing a battery discharge detector in accordance with a method approved by the Manager, International Validation Branch, FAA.
(3) Where the material referenced in EASA AD 2023-0210 specifies “by means of existing hardware,” this AD requires “airworthy hardware.”
(4) Where the material referenced in EASA AD 2023-0210 specifies to “retain hardware,” this AD requires replacing that text with, “retain only airworthy hardware.”
(5) Where paragraph (2) of EASA AD 2023-0210 specifies to inform all flight crews and, thereafter, operate the helicopter accordingly, this AD does not require those actions.
(6) Where paragraph (3) of EASA AD 2023-0210 states “which includes the same content as,” this AD requires replacing that text with “with information identical to that in the “Battery discharging (BATT DISCH)” and “Failure of the generator and d.c. bus (DC GEN)” procedures of the Emergency Procedures section of.”
(7) This AD does not adopt the “Remarks” section of EASA AD 2023-0210.

(i) No Reporting Requirement
Although the material referenced in EASA AD 2023-0210 specifies to submit certain information to the manufacturer, this AD does not include that requirement.

(j) Alternative Methods of Compliance (AMOCs)
(1) The Manager, International Validation Branch, FAA, has the authority to approve AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19, send your request to your principal inspector or local Flight Standards District Office, as appropriate. If sending information directly to the manager of the International Validation Branch, send it to the attention of the person identified in paragraph (k) of this AD. Information may be emailed to: AMOC@faa.gov.
(2) Before using any approved AMOC, notify your appropriate principal inspector, or lacking a principal inspector, the manager of the local flight standards district office/certificate holding district office.

(k) Additional Information
For more information about this AD, contact Dan McCully, Aviation Safety Engineer, FAA, 1600 Stewart Avenue, Suite 410, Westbury, NY 11590; phone: (404) 474-5548; email: william.mccully@faa.gov.

(l) Material Incorporated by Reference
(1) The Director of the Federal Register approved the incorporation by reference of the material listed in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
(2) You must use this material as applicable to do the actions required by this AD, unless this AD specifies otherwise.
(i) European Union Aviation Safety Agency (EASA) AD 2023-0210, dated November 27, 2023.
(ii) [Reserved]
(3) For EASA material identified in this AD, contact EASA, Konrad-Adenauer-Ufer 3, 50668 Cologne, Germany; phone: +49 221 8999 000; email: ADs@easa.europa.eu; website: easa.europa.eu. You may find the EASA material on the EASA website at ad.easa.europa.eu.
(4) You may view this material at the FAA, Office of the Regional Counsel, Southwest Region, 10101 Hillwood Pkwy., Room 6N-321, Fort Worth, TX 76177. For information on the availability of this material at the FAA, call (817) 222-5110.
(5) You may view this material at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, visit www.archives.gov/federal-register/cfr/ibr-locations or email fr.inspection@nara.gov.
Issued on May 7, 2025.
Steven W. Thompson,

Acting Deputy Director, Compliance & Airworthiness Division, Aircraft Certification Service.
DEPARTMENT OF TRANSPORTATION
Federal Aviation Administration
14 CFR Part 39
[Docket No. FAA-2025-0020; Project Identifier MCAI-2024-00604-R; Amendment 39-23031; AD 2025-09-10]
RIN 2120-AA64
Airworthiness Directives; Leonardo S.p.A. Helicopters

AGENCY:
Federal Aviation Administration (FAA), DOT.

ACTION:
Final rule.

SUMMARY:
The FAA is adopting a new airworthiness directive (AD) for certain Leonardo S.p.A. Model A109E, A109S, and AW109SP helicopters. This AD was prompted by reports of incorrect installation of the motor (MTR) cables and the bonding braids connected to the engine fire extinguisher bottles. This AD requires inspecting the cables and bonding braids installation and, depending on the results, accomplishing corrective action, as specified in a European Union Aviation Safety Agency (EASA) AD, which is incorporated by reference. The FAA is issuing this AD to address the unsafe condition on these products.

DATES:
This AD is effective June 16, 2025.
The Director of the Federal Register approved the incorporation by reference of a certain publication listed in this AD as of June 16, 2025.

ADDRESSES:
AD Docket: You may examine the AD docket at regulations.gov under Docket No. FAA-2025-0020; or in person at Docket Operations between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains this final rule, the mandatory continuing airworthiness information (MCAI), any comments received, and other information. The address for Docket Operations is U.S. Department of Transportation, Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE, Washington, DC 20590.
Material Incorporated by Reference:
• For EASA material identified in this AD, contact EASA, Konrad-Adenauer-Ufer 3, 50668 Cologne, Germany; phone: +49 221 8999 000; email: ADs@easa.europa.eu; website: easa.europa.eu. You may find this material on the EASA website at ad.easa.europa.eu.
• You may view this material at the FAA, Office of the Regional Counsel, Southwest Region, 10101 Hillwood Parkway, Room 6N-321, Fort Worth, TX 76177. For information on the availability of this material at the FAA, call (817) 222-5110. It is also available at regulations.gov under Docket No. FAA-2025-0020.

FOR FURTHER INFORMATION CONTACT:
Peter Schmitt, Aviation Safety Engineer, FAA, 1600 Stewart Avenue, Suite 410, Westbury, NY 11590; phone: (425) 394-2768; email: peter.a.schmitt@faa.gov .

SUPPLEMENTARY INFORMATION:

Background
The FAA issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to certain serial-numbered Leonardo S.p.A. Model A109E, A109S, and AW109SP helicopters. The NPRM was published in the Federal Register on February 5, 2025 (90 FR 9011). The NPRM was prompted by AD 2024-0193, dated October 11, 2024, issued by EASA, which is the Technical Agent for the Member States of the European Union (EASA AD 2024-0193) (also referred to as “the MCAI”). The MCAI states that reports were received of incorrect installation of the MTR cables and the bonding braids connected to the engine fire extinguisher bottles. This condition, if not detected and corrected, could lead to reduced performance of the engine fire extinguishing system during an engine fire and consequent loss of control of the helicopter.
In the NPRM, the FAA proposed to require inspecting the cables and bonding braids installation and, depending on the results, disconnecting and properly reinstalling the affected MTR cables and bonding braids. The FAA is issuing this AD to address the unsafe condition on these products.
You may examine the MCAI in the AD docket at regulations.gov under Docket No. FAA-2025-0020.

Comments
The FAA received no comments on the NPRM or on the determination of the costs.

Changes to the NPRM
The FAA has revised the applicability for this AD to remove serial-numbered helicopters that are not eligible for an FAA type certificate. Instead, paragraph (c) of this AD, “Applicability,” lists the applicable helicopters by model and serial number.

Conclusion
These products have been approved by the civil aviation authority of another country and are approved for operation in the United States. Pursuant to the FAA's bilateral agreement with this State of Design Authority, that authority has notified the FAA of the unsafe condition described in the MCAI referenced above. The FAA reviewed the relevant data, considered any comments received, and determined that air safety requires adopting this AD as proposed. Accordingly, the FAA is issuing this AD to address the unsafe condition on these products. Except for minor editorial changes, this AD is adopted as proposed in the NPRM. None of the changes will increase the economic burden on any operator.

Material Incorporated by Reference Under 1 CFR Part 51
The FAA reviewed EASA AD 2024-0193, which specifies procedures for inspecting the left-hand and right-hand side MTR cables and bonding braids for correct installation and, depending on the findings, accomplishing corrective action (disconnecting and properly reinstalling the affected MTR cable(s) and bonding braid(s)). This material is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the ADDRESSES section.

Differences Between This AD and the MCAI
EASA AD 2024-0193 applies to Model A109LUH helicopters; however, this AD does not because that model does not have an FAA type certificate.

Costs of Compliance
The FAA estimates that this AD affects 101 helicopters of U.S. registry. Labor rates are estimated at $85 per hour. Based on these numbers, the FAA estimates the following costs to comply with this AD.
Inspecting the engine fire extinguisher bottle electrical connections takes 1 work-hour for an estimated cost of $85 per helicopter and $8,585 for the U.S. fleet.
Disconnecting and reinstalling the MTR cable(s) and bonding braid(s) takes up to 1 work-hour for an estimated cost of up to $85 per helicopter.

Authority for This Rulemaking
Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. Subtitle VII: Aviation Programs, describes in more detail the scope of the Agency's authority.
The FAA is issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section 44701: General requirements. Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.

Regulatory Findings
This AD will not have federalism implications under Executive Order 13132. This AD will not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.
For the reasons discussed above, I certify that this AD:
(1) Is not a “significant regulatory action” under Executive Order 12866,
(2) Will not affect intrastate aviation in Alaska, and
(3) Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39
Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.

The Amendment
Accordingly, under the authority delegated to me by the Administrator, the FAA amends 14 CFR part 39 as follows:

PART 39—AIRWORTHINESS DIRECTIVES
1. The authority citation for part 39 continues to read as follows:

Authority:
49 U.S.C. 106(g), 40113, 44701.
§ 39.13
[Amended]
2. The FAA amends § 39.13 by adding the following new airworthiness directive:
2025-09-10 Leonardo S.p.A.: Amendment 39-23031; Docket No. FAA-2025-0020; Project Identifier MCAI-2024-00604-R.

(a) Effective Date
This airworthiness directive (AD) is effective June 16, 2025.

(b) Affected ADs
None.

(c) Applicability
This AD applies to Leonardo S.p.A. helicopters identified in paragraphs (c)(1) through (4) of this AD, certificated in any category.
(1) Model A109E helicopters, all serial numbers (S/N).
(2) Model A109S helicopters without Trekker Kit part number (P/N) 109G0000F01 installed, all S/Ns.
(3) Model A109S helicopters with Trekker Kit P/N 109G0000F01installed, S/N 22202, 22088, 22701 through 22741 inclusive, 22743 through 22746 inclusive, and 22748.
(4) Model AW109SP helicopters, S/N 22201, 22203, 22214 through 22362 inclusive, 22364 through 22460 inclusive, and 22462 through 22464 inclusive.

(d) Subject
Joint Aircraft System Component (JASC) Code 2620, Extinguishing System.

(e) Unsafe Condition
This AD was prompted by reports of incorrect installation of the motor (MTR) cables and the bonding braids connected to the engine fire extinguisher bottles. The FAA is issuing this AD to detect and correct incorrect installation of the MTR cables and the bonding braids to the engine fire extinguisher bottles, which could lead to reduced performance of the engine fire extinguishing system during an engine fire and consequent loss of control of the helicopter.

(f) Compliance
Comply with this AD within the compliance times specified, unless already done.

(g) Requirements
Except as specified in paragraphs (h) and (i) of this AD: Comply with all required actions and compliance times specified in, and in accordance with, European Union Aviation Safety Agency AD 2024-0193, dated October 11, 2024 (EASA AD 2024-0193).

(h) Exceptions to EASA AD 2024-0193
(1) Where EASA AD 2024-0193 requires compliance in terms of flight hours, this AD requires using hours time-in-service.
(2) Where EASA AD 2024-0193 refers to its effective date, this AD requires using the effective date of this AD.
(3) Where paragraph (2) of EASA AD 2024-0193 states “any discrepancy,” this AD requires replacing that text with “an improper installation.”
(4) This AD does not adopt the “Remarks” section of EASA AD 2024-0193.

(i) No Reporting Requirement
Although the material referenced in EASA AD 2024-0193 specifies to submit certain information to the manufacturer, this AD does not require that action.

(j) Alternative Methods of Compliance (AMOCs)
(1) The Manager, International Validation Branch, FAA, has the authority to approve AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19, send your request to your principal inspector or local Flight Standards District Office, as appropriate. If sending information directly to the manager of the International Validation Branch, send it to the attention of the person identified in paragraph (k) of this AD and email to: AMOC@faa.gov.
(2) Before using any approved AMOC, notify your appropriate principal inspector, or lacking a principal inspector, the manager of the local flight standards district office/certificate holding district office.

(k) Related Information
For more information about this AD, contact Peter Schmitt, Aviation Safety Engineer, FAA, 1600 Stewart Avenue, Suite 410, Westbury, NY 11590; phone: (206) 231-3377; email: peter.a.schmitt@faa.gov.

(l) Material Incorporated by Reference
(1) The Director of the Federal Register approved the incorporation by reference of the material listed in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
(2) You must use this material as applicable to do the actions required by this AD, unless the AD specifies otherwise.
(i) European Union Aviation Safety Agency (EASA) AD 2024-0193, dated October 11, 2024.
(ii) [Reserved]
(3) For EASA material identified in this AD, contact EASA, Konrad-Adenauer-Ufer 3, 50668 Cologne, Germany; phone: +49 221 8999 000; email: ADs@easa.europa.eu; website: easa.europa.eu. You may find the EASA material on the EASA website at ad.easa.europa.eu.
(4) You may view this material at the FAA, Office of the Regional Counsel, Southwest Region, 10101 Hillwood Parkway, Room 6N-321, Fort Worth, TX 76177. For information on the availability of this material at the FAA, call (817) 222-5110.
(5) You may view this material at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, visit www.archives.gov/federal-register/cfr/ibr-locations or email fr.inspection@nara.gov.
Issued on May 7, 2025.
Steven W. Thompson,

Acting Deputy Director, Compliance & Airworthiness Division, Aircraft Certification Service.
DEPARTMENT OF TRANSPORTATION
Federal Aviation Administration
14 CFR Part 71
[Docket No. FAA-2024-2618; Airspace Docket No. 24-AGL-18]
RIN 2120-AA66
Amendment of United States Area Navigation (RNAV) Route Q-436; Northcentral United States

AGENCY:
Federal Aviation Administration (FAA), DOT.

ACTION:
Final rule.

SUMMARY:
This action amends United States Area Navigation (RNAV) Route Q-436 by changing the name of the “EMMMA”, MI, Fix route point to become the “KAYYS”, MI, Fix. The FAA is taking this action due to the similarly pronounced and sounding names of the EMMMA, MI, Fix and the EMMAS, WI, waypoint (WP) that is located approximately 200 nautical miles (NM) west of the EMMMA Fix. This action is an administrative change to match the Fix name change in the FAA's National Airspace Resource (NASR) database and does not affect the airspace boundaries, route alignment, or operating requirements of Q-436.

DATES:
Effective date 0901 UTC, August 7, 2025. The Director of the Federal Register approves this incorporation by reference action under 1 CFR part 51, subject to the annual revision of FAA Order JO 7400.11 and publication of conforming amendments.

ADDRESSES:
A copy of this final rule and all background material may be viewed online at www.regulations.gov using the FAA Docket number. Electronic retrieval help and guidelines are available on the website. It is available 24 hours each day, 365 days each year.
FAA Order JO 7400.11J, Airspace Designations and Reporting Points, and subsequent amendments can be viewed online at www.faa.gov/air_traffic/publications/. You may also contact the Rules and Regulations Group, Policy Directorate, Federal Aviation Administration, 600 Independence Avenue SW, Washington, DC 20597; telephone: (202) 267-8783.

FOR FURTHER INFORMATION CONTACT:
Colby Abbott, Rules and Regulations Group, Policy Directorate, Federal Aviation Administration, 600 Independence Avenue SW, Washington, DC 20597; telephone: (202) 267-8783.

SUPPLEMENTARY INFORMATION:

Authority for This Rulemaking
The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle I, section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of the airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it modifies the Air Traffic Service (ATS) route structure as necessary to preserve the safe and efficient flow of air traffic within the National Airspace System (NAS).

History
The FAA identified a safety issue associated with communications confusion due to similar sounding fix names of the EMMMA, MI, Fix and the EMMAS, WI, WP that is located approximately 200 NM west of the EMMMA Fix. The EMMAS WP is on the EMMAS ONE ARRIVAL Area Navigation (RNAV) Standard Terminal Arrival Route (STAR) into the Chicago/Rockford International Airport, IL, while the EMMMA Fix is part of the EMMMA Transition on the WYNDE TWO ARRIVAL (RNAV) STAR into the Chicago O'Hare International Airport, IL. To resolve the communications confusion caused when either of these two STARs are issued to arriving aircraft at the supported airports, the Chicago Air Route Traffic Control Center (ARTCC) requested one of the fix names be changed.
The FAA was already updating the WYNDE TWO ARRIVAL STAR when the Chicago ARTCC made the fix name change request, so the EMMMA, MI, Fix was selected to be changed and is being renamed the KAYYS, MI, Fix. As a result of the fix name change from “EMMMA” to “KAYYS”, the RNAV Route Q-436 requires amendment to reflect the EMMMA, MI, Fix route point being changed to the KAYYS, MI, Fix route point. The geographic coordinates for the KAYYS Fix will be the same coordinates used to identify the location of the EMMMA Fix. This change is editorial only to match the FAA NASR database information and does not change the airspace boundaries, alignment, or operational use of the high-altitude RNAV route.

Incorporation by Reference
United States Area Navigation Routes (Q-routes) are published in paragraph 2006 of FAA Order JO 7400.11, Airspace Designations and Reporting Points, which is incorporated by reference in 14 CFR 71.1 on an annual basis. This document amends the current version of that order, FAA Order JO 7400.11J, dated July 31, 2024, and effective September 15, 2024. These amendments will be published in the next update to FAA Order JO 7400.11. FAA Order JO 7400.11J is publicly available as listed in the ADDRESSES section of this document.
FAA Order JO 7400.11J lists Class A, B, C, D, and E airspace areas, air traffic service routes, and reporting points.

The Rule
This action amends 14 CFR part 71 by amending RNAV Route Q-436 by changing the name of the “EMMMA”, MI, Fix route point to the “KAYYS”, MI, Fix. The FAA is taking this action due to the similarly pronounced and sounding names of the EMMMA, MI, Fix and the EMMAS, WI, waypoint (WP). The Q-436 amendment is described below.
Q-436: Prior to this final rule, Q-436 extended between the EMMMA, MI, Fix and the COATE, NJ, Fix. The airspace within Canada was excluded. The FAA changes the EMMMA, MI, Fix route point name to the KAYYS, MI, Fix at the same location. As amended, the route is changed to now extend between the KAYYS, MI, Fix and the COATE, NJ, Fix. The airspace within Canada continues to be excluded.
This action is an administrative change to match the FAA's NASR database information and does not affect the airspace boundaries, alignment, or operating requirements of RNAV Route Q-436; therefore, notice and public procedure under 5 U.S.C. 553(b) is unnecessary.

Regulatory Notices and Analyses
The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. It, therefore: (1) is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. Since this is a routine matter that only affects air traffic procedures and air navigation, it is certified that this rule, when promulgated, does not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

Environmental Review
The FAA has determined that this airspace action of amending RNAV Route Q-436 by changing the name of the “EMMMA”, MI, Fix route point to the “KAYYS”, MI, Fix qualifies for categorical exclusion under the National Environmental Policy Act (42 U.S.C. 4321 et seq. ) and in accordance with FAA Order 1050.1F, Environmental Impacts: Policies and Procedures, paragraph 5-6.5a, which categorically excludes from further environmental impact review rulemaking actions that designate or modify classes of airspace areas, airways, routes, and reporting points (see 14 CFR part 71, Designation of Class A, B, C, D, and E Airspace Areas; Air Traffic Service Routes; and Reporting Points), and paragraph 5-6.5k, which categorically excludes from further environmental impact review publication of existing air traffic control procedures that do not essentially change existing tracks, create new tracks, change altitudes, or change concentration of aircraft on these tracks. As such, this action is not expected to result in any potentially significant environmental impacts. In accordance with FAA Order 1050.1F, paragraph 5-2 regarding Extraordinary Circumstances, the FAA has reviewed this action for factors and circumstances in which a normally categorically excluded action may have a significant environmental impact requiring further analysis. Accordingly, the FAA has determined that no extraordinary circumstances exist that warrant preparation of an environmental assessment or environmental impact statement.

List of Subjects in 14 CFR Part 71
Airspace, Incorporation by reference, Navigation (air).

The Amendment
In consideration of the foregoing, the Federal Aviation Administration amends 14 CFR part 71 as follows:

PART 71—DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR TRAFFIC SERVICE ROUTES; AND REPORTING POINTS
1. The authority citation for 14 CFR part 71 continues to read as follows:

Authority:
49 U.S.C. 106(f), (106)(g), 40103, 40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.
§ 71.1
[Amended]
2. The incorporation by reference in 14 CFR 71.1 of FAA Order JO 7400.11J, Airspace Designations and Reporting Points, dated July 31, 2024, and effective September 15, 2024, is amended as follows:

Paragraph 2006 United States Area Navigation Routes.
* * * * *
Q-436 KAYYS, MI to COATE, NJ [Amended]
KAYYS, MI | FIX | (Lat. 42°53′03.96″ N, long. 084°34′50.40″ W)
YARRK, Canada | WP | (Lat. 42°31′21.79″ N, long. 081°16′05.81″ W)
CHAAP, Canada | WP | (Lat. 42°30′19.02″ N, long. 080°40′57.36″ W)
RAAKK, NY | WP | (Lat. 42°23′59.00″ N, long. 078°54′39.00″ W)
HERBA, NY | WP | (Lat. 42°14′35.29″ N, long. 078°16′27.84″ W)
LAAYK, PA | FIX | (Lat. 41°28′32.64″ N, long. 075°28′57.31″ W)
COATE, NJ | FIX | (Lat. 41°08′10.42″ N, long. 074°41′42.60″ W)
Excluding the airspace in Canada.
* * * * *
Issued in Washington, DC, on May 6, 2025.
Brian Eric Konie,

Manager (A), Rules and Regulations Group.
DEPARTMENT OF TRANSPORTATION
Federal Aviation Administration
14 CFR Part 71
[Docket No. FAA-2024-2405; Airspace Docket No. 24-ASO-17]
RIN 2120-AA66
Establishment of United States Area Navigation (RNAV) Routes T-492 and T-494; Eastern United States

AGENCY:
Federal Aviation Administration (FAA), DOT.

ACTION:
Final rule.

SUMMARY:
This action establishes United States Area Navigation (RNAV) Routes T-492 and T-494 in the eastern United States. This action supports FAA Next Generation Air Transportation System (NextGen) efforts to provide a modern RNAV route structure to improve the safety and efficiency of the National Airspace System (NAS).

DATES:
Effective date 0901 UTC, August 7, 2025. The Director of the Federal Register approves this incorporation by reference action under 1 CFR part 51, subject to the annual revision of FAA Order JO 7400.11 and publication of conforming amendments.

ADDRESSES:
A copy of the Notice of Proposed Rulemaking (NPRM), all comments received, this final rule, and all background material may be viewed online at www.regulations.gov using the FAA Docket number. Electronic retrieval help and guidelines are available on the website. It is available 24 hours each day, 365 days each year.
FAA Order JO 7400.11J, Airspace Designations and Reporting Points, and subsequent amendments can be viewed online at www.faa.gov/air_traffic/publications/. You may also contact the Rules and Regulations Group, Policy Directorate, Federal Aviation Administration, 600 Independence Avenue SW, Washington, DC 20597; telephone: (202) 267-8783.

FOR FURTHER INFORMATION CONTACT:
Brian Vidis, Rules and Regulations Group, Policy Directorate, Federal Aviation Administration, 600 Independence Avenue SW, Washington, DC 20597; telephone: (202) 267-8783.

SUPPLEMENTARY INFORMATION:

Authority for This Rulemaking
The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle I, Section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of the airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it modifies the Air Traffic Service (ATS) route structure as necessary to preserve the safe and efficient flow of air traffic within the NAS.

History
The FAA published a NPRM for Docket No. FAA 2024-2405 in the Federal Register (89 FR 84841; October 24, 2024), proposing to establish RNAV Routes T-492 and T-494 in the eastern United States. Interested parties were invited to participate in this rulemaking effort by submitting written comments on the proposal to the FAA. No comments were received.

Incorporation by Reference
United States Area Navigation routes are published in paragraph 6011 of FAA Order JO 7400.11, Airspace Designations and Reporting Points, which is incorporated by reference in 14 CFR 71.1 on an annual basis. This document amends the current version of that order, FAA Order JO 7400.11J, dated July 31, 2024, and effective September 15, 2024. These amendments will be published in the next update to FAA Order JO 7400.11. FAA Order JO 7400.11J is publicly available as listed in the ADDRESSES section of this document. FAA Order JO 7400.11J lists Class A, B, C, D, and E airspace areas, air traffic service routes, and reporting points.

The Rule
This action amends 14 CFR part 71 by establishing RNAV Routes T-492 and T-494 in the eastern United States. This action supports the FAA's NextGen efforts to provide a modern RNAV route structure to improve the safety and efficiency of the NAS. The amendments are described below.
T-492: T-492 is a new RNAV route that extends between the FIINN, FL, waypoint (WP) and the DEARY, FL, Fix. The route provides RNAV connectivity for aircraft operating under instrument flight rules (IFR) to transition between the east and west sides of the Tampa International Airport, FL, and overlays VOR Federal Airway V-441 between the YOJIX, FL, Fix and the DEARY Fix.
T-494: T-494 is a new RNAV route that extends between the SKWAD, FL, WP and the TWOON, FL, WP. The route provides RNAV connectivity for aircraft operating under IFR to transition between the east and west sides of the Orlando International Airport, FL.

Regulatory Notices and Analyses
The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. It, therefore: (1) is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. Since this is a routine matter that only affects air traffic procedures and air navigation, it is certified that this rule, when promulgated, does not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

Environmental Review
The FAA has determined that this airspace action of establishing RNAV Routes T-492 and T-494 qualifies for categorical exclusion under the National Environmental Policy Act (42 U.S.C. 4321, et seq. ), and in accordance with FAA Order 1050.1F, Environmental Impacts: Policies and Procedures, paragraph 5-6.5a, which categorically excludes from further environmental impact review rulemaking actions that designate or modify classes of airspace areas, airways, routes, and reporting points (see 14 CFR part 71, Designation of Class A, B, C, D, and E Airspace Areas; Air Traffic Service Routes; and Reporting Points); and paragraph 5-6.5b, which categorically excludes from further environmental impact review “Actions regarding establishment of jet routes and Federal airways (see 14 CFR 71.15, Designation of jet routes and VOR Federal airways ) . . .”, and paragraph 5-6.5i, which categorically excludes from further environmental review the establishment of new or revised air traffic control procedures conducted at 3,000 feet or more above ground level (AGL); procedures conducted below 3,000 feet AGL that do not cause traffic to be routinely routed over noise sensitive areas; modifications to currently approved procedures conducted below 3,000 feet AGL that do not significantly increase noise over noise sensitive areas; and increases in minimum altitudes and landing minima. As such, this action is not expected to result in any potentially significant environmental impacts. In accordance with FAA Order 1050.1F, paragraph 5-2 regarding Extraordinary Circumstances, the FAA has reviewed this action for factors and circumstances in which a normally categorically excluded action may have a significant environmental impact requiring further analysis. Accordingly, the FAA has determined that no extraordinary circumstances exist that warrant preparation of an environmental assessment or environmental impact statement.

List of Subjects in 14 CFR Part 71
Airspace, Incorporation by reference, Navigation (air).

The Amendment
In consideration of the foregoing, the Federal Aviation Administration amends 14 CFR part 71 as follows:

PART 71—DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR TRAFFIC SERVICE ROUTES; AND REPORTING POINTS
1. The authority citation for 14 CFR part 71 continues to read as follows:

Authority:
49 U.S.C. 106(f), 106(g); 40103, 40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.
§ 71.1
[Amended]
2. The incorporation by reference in 14 CFR 71.1 of FAA Order JO 7400.11J, Airspace Designations and Reporting Points, dated July 31, 2024, and effective September 15, 2024, is amended as follows:

Paragraph 6011 United States Area Navigation Routes.
* * * * *
T-492 FIINN, FL to DEARY, FL [New]
FIINN, FL | WP | (Lat. 27°58′36.45″ N, long. 082°46′57.63″ W)
PMPNO, FL | WP | (Lat. 27°57′57.52″ N, long. 082°19′18.44″ W)
WEZER, FL | WP | (Lat. 28°02′26.59″ N, long. 082°02′39.60″ W)
YOJIX, FL | FIX | (Lat. 28°02′44.04″ N, long. 081°33′45.34″ W)
ODDEL, FL | FIX | (Lat. 28°05′45.51″ N, long. 081°10′10.24″ W)
DEARY, FL | FIX | (Lat. 28°06′02.53″ N, long. 080°54′51.40″ W)
T-494 SKWAD, FL to TWOON, FL [New]
SKWAD, FL | WP | (Lat. 28°25′45.51″ N, long. 081°27′23.25″ W)
TWOON, FL | WP | (Lat. 28°25′45.46″ N, long. 081°08′54.93″ W)
* * * * *
Issued in Washington, DC, on May 6, 2025.
Brian Eric Konie,

Manager (A), Rules and Regulations Group.
DEPARTMENT OF TRANSPORTATION
Federal Aviation Administration
14 CFR Part 71
[Docket No. FAA-2024-2573; Airspace Docket No. 23-AGL-20]
RIN 2120-AA66
Amendment of Jet Route J-538 and VOR Federal Airway V-129; Establishment of Canadian RNAV Routes Q-828, Q-945, Q-971, and T-797; and Revocation of Jet Routes J-483 and J-562; Northcentral United States

AGENCY:
Federal Aviation Administration (FAA), DOT.

ACTION:
Final rule.

SUMMARY:
This action amends Jet Route J-538 and Very High Frequency Omnidirectional Range (VOR) Federal Airway V-129; establishes Canadian Area Navigation (RNAV) Routes Q-828, Q-945, Q-971, and T-797 within United States (U.S.) airspace; and revokes Jet Routes J-483 and J-562. The FAA is taking this action due to NAV CANADA's decommissioning of the Sioux Narrows (VBI), Ontario (ON), Canada, Very High Frequency Omnidirectional Range (VOR)/Distance Measuring Equipment (VOR/DME) navigational aid (NAVAID), and the planned decommissioning of the Lumsden (VLN), Saskatchewan (SK), Canada, VOR/Tactical Air Navigation (VORTAC) and Brandon (YBR), Manitoba (MB), Canada, VORTAC NAVAIDs. This action supports NAV CANADA's NAVAID Modernization Program.

DATES:
Effective date 0901 UTC, August 7, 2025. The Director of the Federal Register approves this incorporation by reference action under 1 CFR part 51, subject to the annual revision of FAA Order JO 7400.11 and publication of conforming amendments.

ADDRESSES:
A copy of the Notice of Proposed Rulemaking (NPRM), all comments received, this final rule, and all background material may be viewed online at www.regulations.gov using the FAA Docket number. Electronic retrieval help and guidelines are available on the website. It is available 24 hours each day, 365 days each year.
FAA Order JO 7400.11J, Airspace Designations and Reporting Points, and subsequent amendments can be viewed online at www.faa.gov/air_traffic/publications/. You may also contact the Rules and Regulations Group, Policy Directorate, Federal Aviation Administration, 600 Independence Avenue SW, Washington, DC 20597; telephone: (202) 267-8783.

FOR FURTHER INFORMATION CONTACT:
Colby Abbott, Rules and Regulations Group, Policy Directorate, Federal Aviation Administration, 600 Independence Avenue SW, Washington, DC 20597; telephone: (202) 267-8783.

SUPPLEMENTARY INFORMATION:

Authority for This Rulemaking
The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle I, Section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of the airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it modifies the National Airspace System (NAS) as necessary to preserve the safe and efficient flow of air traffic.

History
The FAA published an NPRM for Docket No. FAA-2024-2573 in the Federal Register (89 FR 97574; December 9, 2024), proposing to amend Jet Route J-538 and VOR Federal Airway V-129; establish Canadian RNAV Routes Q-828, Q-945, Q-971, and T-797 within U.S. airspace; and revoke Jet Routes J-483 and J-562. The proposed action was due to NAV CANADA's decommissioning of the Sioux Narrows, ON, Canada, VOR/DME NAVAID and the planned decommissioning of the Lumsden, SK, Canada, and Brandon, MB, Canada, VORTAC NAVAIDs. Interested parties were invited to participate in this rulemaking effort by submitting written comments on the proposal. No comments were received.

Differences From the NPRM
Subsequent to the NPRM, the FAA discovered the Canadian RNAV Route Q-828 description published in the proposal section and the proposed regulatory text of the NPRM was listed in reverse order and reflected an east to west orientation, in error. Based on the route identifier being an even number, the route should be published in a west to east orientation. This rule incorporates a correction of that error and reflects Canadian RNAV route extending between the FARID, MN, waypoint (WP) and the Duluth, MN, VORTAC.

Incorporation by Reference
Jet Routes are published in paragraph 2004, Canadian Area Navigation Routes (Q-routes) are published in paragraph 2007, VOR Federal Airways are published in paragraph 6010(a), and Canadian Area Navigation Routes (T-routes) are published in paragraph 6013 of FAA Order JO 7400.11, Airspace Designations and Reporting Points, which is incorporated by reference in 14 CFR 71.1 on an annual basis. This document amends the current version of that order, FAA Order JO 7400.11J, dated July 31, 2024, and effective September 15, 2024. These amendments will be published in the next update to FAA Order JO 7400.11. FAA Order JO 7400.11J is publicly available as listed in the ADDRESSES section of this document.
FAA Order JO 7400.11J lists Class A, B, C, D, and E airspace areas, air traffic service routes, and reporting points.

The Rule
This action amends 14 CFR part 71 by amending Jet Route J-538 and VOR Federal Airway V-129; establishing Canadian RNAV Routes Q-828, Q-945, Q-971, and T-797 in U.S. airspace; and revoking Jet Routes J-483 and J-562. The FAA is taking this action due to the decommissioning of the Sioux Narrows, ON, Canada, VOR/DME and the planned decommissioning of the Lumsden, SK, Canada, and Brandon, MB, Canada, VORTAC NAVAIDs by NAV CANADA in support of their NAVAID Modernization Program. The Air Traffic Service (ATS) route actions are described below.
J-48 3: Prior to this final rule, J-483 extended between the Minot, ND, VOR/DME and the Lumsden, SK, Canada, VORTAC. The airspace within Canada was excluded. The route is removed in its entirety.
J-538: Prior to this final rule, J-538 extended between the Sioux Narrows, ON, Canada, VOR/DME and the Badger, WI, VOR/DME. The airspace within Canada was excluded. The route segment between the Sioux Narrows, ON, VOR/DME and the Duluth, MN, VORTAC is removed. As amended, the route is changed to now extend between the Duluth VORTAC and the Badger VOR/DME.
J-562: Prior to this final rule, J-562 extended between the Dickinson, ND, VORTAC and the Brandon, MB, Canada, VORTAC. The airspace within Canada was excluded. The route is removed in its entirety.
Q-828: Q-828 is a new Canadian RNAV route established by this rule within U.S. airspace extending between the FARID, MN, WP, which replaces the “CFCJN” Computer Navigation Fix (CNF) on the U.S./Canada border, and the Duluth, MN, VORTAC. The new RNAV route mitigates the J-538 amendment and provides route continuity and cross-border connectivity with the RNAV Route Q-828 established by NAV CANADA within Canadian airspace.
Q-945: Q-945 is a new Canadian RNAV route established by this rule within U.S. airspace extending between the Dickinson, ND, VORTAC and the OSMEE, ND, WP, which replaces the “CFMSZ” CNF on the U.S./Canada border. The new RNAV route mitigates the J-562 revocation and provides route continuity and cross-border connectivity with the RNAV Route Q-945 established by NAV CANADA within Canadian airspace.
Q-971: Q-971 is a new Canadian RNAV route established by this rule within U.S. airspace extending between the Minot, ND, VOR/DME and the CIPTA, ND, WP, which replaces the “CFHLT” CNF on the U.S./Canada border. The new RNAV route mitigates the J-483 revocation and provides route continuity and cross-border connectivity with the RNAV Route Q-971 established by NAV CANADA within Canadian airspace.
V-129: Prior to this final rule, V-129 extended between the Spinner, IL, VORTAC and the intersection of the International Falls, MN, VOR/DME 335° radial and U.S./Canadian border. The airway segment between the International Falls VOR/DME and the intersection of the International Falls VOR/DME 335° radial and U.S./Canadian border is removed. As amended, the airway is changed to now extend between the Spinner VORTAC and the International Falls VOR/DME.
T-797: T-797 is a new Canadian RNAV route established by this rule within U.S. airspace extending between the International Falls, MN, VOR/DME and the WUGOR, MN, WP, which replaces the “CFDTS” CNF on the U.S./Canada border. The new RNAV route mitigates the V-129 airway segment removal and provides route continuity and cross-border connectivity with the RNAV Route T-797 established by NAV CANADA within Canadian airspace.
The NAVAID radials listed in the VOR Federal Airway V-129 description in the regulatory text of this final rule are unchanged and stated in degrees True north.

Regulatory Notices and Analyses
The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. It, therefore: (1) is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. Since this is a routine matter that only affects air traffic procedures and air navigation, it is certified that this rule, when promulgated, does not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

Environmental Review
The FAA has determined that this action amending Jet Route J-538 and VOR Federal Airway V-129; establishing Canadian RNAV Routes Q-828, Q-945, Q-971, and T-797 in U.S. airspace; and revoking Jet Routes J-483 and J-562 due to the decommissioning of the Sioux Narrows, ON, Canada, VOR/DME and the planned decommissioning of the Lumsden, SK, Canada, and Brandon, MB, Canada, VORTAC NAVAIDs by NAV CANADA, qualifies for categorical exclusion under the National Environmental Policy Act (42 U.S.C. 4321, et seq. ) and in accordance with FAA Order 1050.1F, Environmental Impacts: Policies and Procedures, paragraph 5-6.5a, which categorically excludes from further environmental impact review rulemaking actions that designate or modify classes of airspace areas, airways, routes, and reporting points (see 14 CFR part 71, Designation of Class A, B, C, D, and E Airspace Areas; Air Traffic Service Routes; and Reporting Points); and paragraph 5-6.5k, which categorically excludes from further environmental impact review the publication of existing air traffic control procedures that do not essentially change existing tracks, create new tracks, change altitude, or change concentration of aircraft on these tracks. As such, this action is not expected to result in any potentially significant environmental impacts. In accordance with FAA Order 1050.1F, paragraph 5-2 regarding Extraordinary Circumstances, the FAA has reviewed this action for factors and circumstances in which a normally categorically excluded action may have a significant environmental impact requiring further analysis. The FAA has determined that no extraordinary circumstances exist that warrant preparation of an environmental assessment or environmental impact study.

List of Subjects in 14 CFR Part 71
Airspace, Incorporation by reference, Navigation (air).

The Amendment
In consideration of the foregoing, the Federal Aviation Administration amends 14 CFR part 71 as follows:

PART 71—DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR TRAFFIC SERVICE ROUTES; AND REPORTING POINTS
1. The authority citation for 14 CFR part 71 continues to read as follows:

Authority:
49 U.S.C. 106(f), 106(g), 40103, 40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.
§ 71.1
[Amended]
2. The incorporation by reference in 14 CFR 71.1 of FAA Order JO 7400.11J, Airspace Designations and Reporting Points, dated July 31, 2024, and effective September 15, 2024, is amended as follows:

Paragraph 2004 Jet Routes.
* * * * *

J-483 [Removed]
* * * * *

J-538 [Amended]
From Duluth, MN; Dells, WI; to Badger, WI.
* * * * *

J-562 [Removed]
* * * * *

Paragraph 2007 Canadian Area Navigation Routes.
* * * * *
Q-828 FARID, MN to Duluth, MN (DLH) [New]
FARID, MN | WP | (Lat. 48°36′13.96″ N, long. 093°25′16.09″ W)
Duluth, MN (DLH) | VORTAC | (Lat. 46°48′07.79″ N, long. 092°12′10.33″ W)
* * * * *
Q-945 Dickinson, ND (DIK) to OSMEE, ND [New]
Dickinson, ND (DIK) | VORTAC | (Lat. 46°51′36.14″ N, long. 102°46′24.60″ W)
OSMEE, ND | WP | (Lat. 48°59′59.19″ N, long. 100°49′57.63″ W)
* * * * *
Q-971 Minot, ND (MOT) to CIPTA, ND [New]
Minot, ND (MOT) | VOR/DME | (Lat. 48°15′37.21″ N, long. 101°17′13.46″ W)
CIPTA, ND | WP | (Lat. 48°59′55.84″ N, long. 102°20′17.11″ W)

Paragraph 6010(a) VOR Federal Airways.
* * * * *

V-129 [Amended]
From Spinner, IL; Peoria, IL; Davenport, IA; Dubuque, IA; INT Dubuque 348° and Nodine, MN, 150° radials; Nodine; Eau Claire, WI; Duluth, MN; Hibbing, MN; to International Falls, MN.
* * * * *

Paragraph 6013 Canadian Area Navigation Routes.
* * * * *
T-797 International Falls, MN (INL) to WUGOR, MN [New]
International Falls, MN (INL) | VOR/DME | (Lat. 48°33′56.87″ N, long. 093°24′20.44″ W)
WUGOR, MN | WP | (Lat. 48°35′58.85″ N, long. 093°25′44.53″ W)
Issued in Washington, DC, on May 6, 2025.
Brian Eric Konie,

Manager (A), Rules and Regulations Group.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 73
[Docket No. FDA-2023-C-0544]
Listing of Color Additives Exempt From Certification; Calcium Phosphate

AGENCY:
Food and Drug Administration, HHS.

ACTION:
Final amendment; order.

SUMMARY:
The Food and Drug Administration (FDA or we) is amending the color additive regulations to provide for the safe use of calcium phosphate as a color additive in ready-to-eat chicken products, white candy melts, doughnut sugar, and sugar for coated candies. This action is in response to a color additive petition (CAP) filed by Innophos, Inc. (Innophos or petitioner).

DATES:
This order is effective June 26, 2025. See section VIII for further information on the filing of objections. Either electronic or written objections and requests for a hearing on the final order must be submitted by June 11, 2025.

ADDRESSES:
You may submit objections and requests for a hearing as follows. Please note that late, untimely filed objections will not be considered. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of June 11, 2025. Objections received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are received on or before that date.

Electronic Submissions
Submit electronic objections in the following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the instructions for submitting comments. Objections submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because your objection will be made public, you are solely responsible for ensuring that your objection does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your objection, that information will be posted on https://www.regulations.gov.
• If you want to submit an objection with confidential information that you do not wish to be made available to the public, submit the objection as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).

Written/Paper Submissions
Submit written/paper submissions as follows:
• Mail/Hand Delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper objections submitted to the Dockets Management Staff, FDA will post your objection, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
Instructions: All submissions received must include the Docket No. FDA-2023-C-0544 for “Listing of Color Additives Exempt from Certification; Calcium Phosphate.” Received objections, those filed in a timely manner (see ADDRESSES ), will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
• Confidential Submissions—To submit an objection with confidential information that you do not wish to be made publicly available, submit your objections only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” We will review this copy, including the claimed confidential information, in our consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500.

FOR FURTHER INFORMATION CONTACT:
Rachel Morissette, Office of Food Chemical Safety, Dietary Supplements, and Innovation, Human Foods Program, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-1212; or Barbara Little, Office of Policy, Regulations, and Information, Human Foods Program, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-2378.

SUPPLEMENTARY INFORMATION:

I. Introduction
In a document published in the Federal Register of February 27, 2023 (88 FR 12281), we announced that we filed a color additive petition (CAP 3C0324) submitted on behalf of Innophos by Steptoe & Johnson LLP, 1330 Connecticut Avenue NW, Washington, DC 20036-1795. The petition proposed to amend the color additive regulations in part 73 (21 CFR part 73), Listing of Color Additives Exempt from Certification, to provide for the safe use of calcium phosphate as a color additive, by weight of the finished food, in ready-to-eat chicken products; icing; white candy melts; doughnut sugar; and sugar for coated candies. In the petition and filing notice, the color additive was identified as “tricalcium phosphate.” During the course of our review, we determined that the correct nomenclature for the color additive is “calcium phosphate.” Additionally, during the course of our review and in consultation with FDA, Innophos amended the intended uses to remove icing in order to reduce overall dietary exposure to calcium.
Calcium phosphate is a white, synthetically prepared powder consisting predominantly of precipitated Ca 5 OH(PO 4 ) 3 . Innophos proposed the following specifications for calcium phosphate: loss on ignition, not more than 10 percent; assay (Ca), 36.0-40.0 percent; fluoride, not more than 75 milligrams/kilogram (mg/kg) (75 parts per million (ppm)); lead, not more than 0.25 mg/kg (0.25 ppm); and arsenic, not more than 3 mg/kg (3 ppm) (Ref. 1).
Calcium phosphate is generally recognized as safe (GRAS) for use as a nutrient or multiple purpose ingredient in food with no limitation other than use in accordance with good manufacturing practice under 21 CFR 182.8217 and 21 CFR 182.1217. Additionally, we have previously evaluated the safety of substances containing calcium and/or phosphate as constituent ions in numerous food and color additive regulations and in GRAS notices.
This final order is expected to result in expanded production options and is considered an E.O. 14192 deregulatory action.

II. Safety Evaluation
Under section 721(b)(4) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 379e(b)(4)), a color additive cannot be listed for an intended use unless the data and information available to us establishes that the color additive is safe for that use. Our color additive regulations in § 70.3(i) (21 CFR 70.3(i)) define “safe” to mean that there is convincing evidence establishing with reasonable certainty that no harm will result from the intended use of the color additive. As part of our safety evaluation to establish with reasonable certainty that a color additive is not harmful under its intended conditions of use, we consider the color additive's manufacturing and stability; the projected human dietary exposure to the color additive and any impurities resulting from the petitioned use of the color additive; the additive's toxicological data; and other relevant information (such as published literature) available to us.

A. Estimated Dietary Exposure
To support the safety of the intended use of calcium phosphate, Innophos provided dietary exposure estimates for calcium phosphate, calcium, and phosphorus from the petitioned uses. The petitioned uses included in ready-to-eat chicken products in an amount not exceeding 1.5 percent; in white candy melts in an amount not exceeding 0.25 percent; in doughnut sugar in an amount not exceeding 2.0 percent; and in sugar for coated candies in an amount not exceeding 5.25 percent by weight of the finished food. During review of the petition, Innophos revised the use level in sugar for coated candies from 7.5% to 5.25%. Innophos provided a cumulative dietary exposure for: (1) calcium from background dietary sources, including dietary supplements and drugs, as well as the intended uses of the color additive and (2) for phosphorus based on the intended uses (Ref. 2).
Innophos provided a cumulative dietary exposure to calcium from the intended uses and calcium from background dietary sources, including dietary supplements, by utilizing a simplistic model of the National Cancer Institute (NCI) usual intakes method for estimating dietary exposure (Ref. 2). We noted that Innophos did not include all relevant food codes, may have overestimated exposure by summing the food category exposures, and did not provide a 90th percentile dietary exposure for phosphorus. Therefore, we conducted a dietary exposure estimate and estimated the updated dietary exposure for calcium phosphate, calcium, and phosphorus from the petitioned uses based on the 2015-2020 Nutritional Health and Nutrition Examination Survey (NHANES) to be 535 milligrams (mg)/person (p)/day (d), 214 mg/p/d, and 99 mg/p/d, respectively, at the mean and 1200 mg/p/d, 480 mg/p/d, and 222 mg/p/d, respectively, at the 90th percentile for the U.S. population ages 2 years and older (Ref. 2). Additionally, using 2015-2020 NHANES food consumption data combined with the NCI usual intakes method, we estimated the cumulative dietary exposure to calcium from the background dietary sources, including dietary supplements and drugs, and the petitioned uses to be 1195 mg/p/d at the mean and 1789 mg/p/d at the 90th percentile for the U.S. population ages 2 years and older (Ref. 2). Using 2015-2020 NHANES food consumption data, we also estimated the cumulative dietary exposure to phosphorus from the background dietary sources, including dietary supplements and drugs, and the petitioned uses to be 1330 mg/p/d at the mean and 2010 mg/p/d at the 90th percentile for the U.S. population ages 2 years and older (Ref. 2).

B. Toxicological Considerations
Innophos submitted peer-reviewed published data sourced from a literature review and additional information relevant to the safety of calcium phosphate for the intended use as a color additive. Based on the physiochemical properties of calcium phosphate and the rapid dissolution of the salt into its component ions, the safety conclusion predominantly focuses on the safety of calcium and phosphorus.
Based on the cumulative dietary exposure for calcium from the petitioned uses of calcium phosphate and the contribution of calcium from background dietary sources, including dietary supplements, we concluded that the estimated 90th percentile cumulative dietary exposure for calcium from all dietary calcium sources does not exceed the current Institute of Medicine (IOM) Upper Limit (UL) of 2000 mg/p/d for calcium intake for all assessed populations (Refs. 2 and 3).
Based on the cumulative dietary exposure for phosphorus from the petitioned uses of calcium phosphate and the contribution of phosphorus from background dietary sources, including dietary supplements, we concluded that the estimated 90th percentile cumulative dietary exposure for phosphorus from all dietary phosphorus sources does not exceed the current IOM UL of 3000 mg/p/d for phosphorus intake for all assessed populations (Refs. 2 and 3).
Innophos conducted a comprehensive evaluation of the available literature for information pertinent to the safety of calcium phosphate, as well as available safety assessments of dietary calcium and phosphorus by other regulatory bodies, including the IOM report on Dietary Reference Intakes (DRI), Joint Food and Agriculture Organization/World Health Organization Expert Committee on Food Additives (JECFA), and the European Food Safety Authority (EFSA). Innophos provided a safety summary for calcium phosphate and its components, calcium and phosphorus, noting that when used in food, calcium phosphate is expected to dissociate in the gastrointestinal tract to conjugate ionic salts of calcium and inorganic phosphate (phosphorus).
Calcium is an essential micronutrient necessary for numerous physiological processes, including formation/metabolism of bone, and intracellular signaling related to muscular function, vascular contraction/dilation, nerve transmission, and hormonal secretion. Maintenance of calcium balance in the body within a narrow physiological range is essential for normative function. In 2011, the IOM reassessed the DRI for calcium based on newly available scientific information/data generated since its previous assessment. The IOM panel noted that excess intake of calcium was unlikely related to calcium intake from conventional foods, and higher intake levels often corresponded with use of calcium dietary supplements. The IOM panel specified that the efficiency of calcium absorption is in reverse proportion to the amount of calcium consumed at one time to maintain physiologic calcium balance and may vary based on vitamin D status. The IOM panel identified several potential indicators of adverse outcomes for excess calcium intake, including hypercalcemia, hypercalciuria, vascular and soft tissue calcification, nephrolithiasis (kidney stones), prostate cancer, interactions with iron and zinc, and constipation. As a result, IOM established a calcium UL between 2000 and 3000 mg/d for each DRI life-stage group. Our literature search identified no new publications relevant to the safe use of calcium in food. Therefore, the current state of the science supports the continued use of the IOM UL for calcium intake as a dietary reference value to support public health (Ref. 3).
Phosphorus is ubiquitously present across the food supply as organic phosphorus in various sources, such as dairy, meats, legumes, and nuts, or inorganic phosphorus related to the use of phosphorus salts. Phosphorus is an essential mineral that is a major component of healthy bones and teeth, and critical for numerous physiological functions, including pH homeostasis, energy metabolism, and cellular signaling mediated via phosphorylation and dephosphorylation events. Phosphorus is also a key component of phospholipid membranes and nucleic acids. The IOM panel noted that dietary phosphorus supports tissue growth and replacement of phosphorus lost due to excretion and desquamation of skin cells.
Innophos summarized the scientific literature on the safety of phosphorus and other phosphate salts, including genotoxicity assessments, systemic toxicity studies, carcinogenicity studies, and reproductive and developmental studies, focusing on studies using oral administration. Innophos summarized additional data/studies of various phosphate salts in support of the safety of calcium phosphate. Additionally, Innophos discussed published scientific opinions from JECFA, the EFSA Panel on Food Additives and Flavourings, and the IOM DRI to establish upper limits for phosphorus intake. The IOM panel noted that all adverse effects of excess phosphorous consumption corresponded to elevated inorganic phosphorus in the extracellular fluid. Hyperphosphatemia from dietary sources is a potential concern for individuals diagnosed with end-stage renal disease and is associated with reduced calcium absorption and potential calcification of non-skeletal tissues, particularly the kidney. Based on the weight of evidence, the IOM panel utilized intakes of phosphorus corresponding to normal circulating levels of inorganic phosphate in healthy adults and the application of a factorial approach for other relevant populations to support DRI derivation. The panel recognized the likely need for higher recommended daily allowances of phosphorus during periods of rapid growth in children. As a result, the IOM established a phosphorus UL between 3000 and 4000 mg/d for each DRI life-stage group. Our literature search identified no new publications relevant to the safe use of phosphorous in food. Therefore, the current state of the science supports the continued use of the IOM UL for phosphorus intake as a dietary reference value to support public health (Ref. 3).
Based on the totality of the safety data provided by Innophos and otherwise available to us, including supporting literature on the safety of calcium phosphate and its constituent ions, expert opinions from other regulatory bodies on safe dietary intake levels of calcium and phosphorous, and that the estimated 90th percentile cumulative dietary exposures for calcium and phosphorus from all sources (petitioned intended uses, and background dietary sources, including dietary supplements and drugs) does not exceed the IOM UL established for dietary calcium and phosphorous, we conclude that there is a reasonable certainty of no harm from the intended uses of calcium phosphate as a color additive in ready-to-eat chicken products, white candy melts, doughnut sugar, and sugar for coated candies.

III. Conclusion
Based on the data and information in the petition and other relevant material, we conclude that the petitioned use of calcium phosphate as a color additive, by weight of the finished food, in ready-to-eat chicken products in an amount not exceeding 1.5 percent; in white candy melts in an amount not exceeding 0.25 percent; in doughnut sugar in an amount not exceeding 2.0 percent; and in sugar for coated candies in an amount not exceeding 5.25 percent is safe. We further conclude that the color additive will achieve its intended technical effect and is suitable for the petitioned use. Consequently, we are amending the color additive regulations in 21 CFR part 73 as set forth in this document. In addition, based upon the factors listed in 21 CFR 71.20(b), we conclude that certification of calcium phosphate is not necessary for the protection of public health.

IV. Public Disclosure
In accordance with § 71.15 (21 CFR 71.15), the petition and the documents that we considered and relied upon in reaching our decision to approve the petition will be made available for public disclosure (see FOR FURTHER INFORMATION CONTACT ). As provided in § 71.15, we will delete from the documents any materials that are not available for public disclosure.

V. Analysis of Environmental Impact
As stated in the February 27, 2023 (88 FR 12281) Federal Register notification of petition for CAP 3C0324, the petitioner claimed that this action is categorically excluded under 21 CFR 25.32(k) because calcium phosphate added directly to food is intended to remain in food through ingestion by consumers and is not intended to replace macronutrients in food. We further stated that, if FDA determines a categorical exclusion applies, neither an environmental assessment nor an environmental impact statement is required. We did not receive any new information or comments regarding this claim of categorical exclusion. We considered the petitioner's claim of categorical exclusion and determined that this action is categorically excluded under 21 CFR 25.32(k). Therefore, neither an environmental assessment nor an environmental impact statement is required.

VI. Paperwork Reduction Act of 1995
This order contains no collection of information. Therefore, clearance by the Office of Management and Budget under the Paperwork Reduction Act of 1995 is not required.

VII. Section 301(ll) of the FD&C Act
Our review of this petition was limited to section 721 of the FD&C Act. This order is not a statement regarding compliance with other sections of the FD&C Act. For example, section 301(ll) of the FD&C Act (21 U.S.C. 331(ll)) prohibits the introduction or delivery for introduction into interstate commerce of any food that contains a drug approved under section 505 of the FD&C Act (21 U.S.C. 355), a biological product licensed under section 351 of the Public Health Service Act (42 U.S.C. 262), or a drug or biological product for which substantial clinical investigations have been instituted and their existence has been made public, unless one of the exemptions in section 301(ll)(1) through (4) of the FD&C Act applies. In our review of this petition, we did not consider whether section 301(ll) of the FD&C Act or any of its exemptions apply to food containing this color additive. Accordingly, this order should not be construed to be a statement that a food containing this color additive, if introduced or delivered for introduction into interstate commerce, would not violate section 301(ll) of the FD&C Act. Furthermore, this language is included in all color additive orders that pertain to food and therefore should not be construed to be a statement of the likelihood that section 301(ll) of the FD&C Act applies.

VIII. Objections
This order is effective as shown in the DATES section, except as to any provisions that may be stayed by the filing of proper objections. If you will be adversely affected by one or more provisions of this regulation, you may file with the Dockets Management Staff (see ADDRESSES ) either electronic or written objections. You must separately number each objection, and within each numbered objection you must specify with particularity the provision(s) to which you object, and the grounds for your objection. Within each numbered objection, you must specifically state whether you are requesting a hearing on the particular provision that you specify in that numbered objection. If you do not request a hearing for any particular objection, you waive the right to a hearing on that objection. If you request a hearing, your objection must include a detailed description and analysis of the specific factual information you intend to present in support of the objection in the event that a hearing is held. If you do not include such a description and analysis for any particular objection, you waive the right to a hearing on the objection.
Any objections received in response to the regulation may be seen in the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at https://www.regulations.gov. We will publish notice of the objections that we have received or lack thereof in the Federal Register .

IX. References
The following references marked with an asterisk (*) are on display at the Dockets Management Staff (see ADDRESSES ) and are available for viewing by interested persons between 9 a.m. and 4 p.m., Monday through Friday; they are also available electronically at https://www.regulations.gov. FDA has verified the website addresses, as of the date this document publishes in the Federal Register , but websites are subject to change over time.
* 1. Memorandum from J. Barrows, Color Technology Branch, Office of Cosmetics and Colors, Office of the Chief Scientist, FDA to R. Morissette, Regulatory Management Branch (RMB), Division of Food Ingredients (DFI), Office of Pre-Market Additive Safety (OPMAS), Office of Food Chemical Safety, Dietary Supplements, and Innovation (OFCSDSI), Human Foods Program (HFP), FDA, April 23, 2025.
* 2. Memorandum from T. Todorov, Chemistry Review Branch, DFI, OPMAS, OFCSDSI, FDA to R. Morissette, RMB, DFI, OPMAS, OFCSDSI, HFP, FDA, April 22, 2025.
* 3. Memorandum from T. Hubbard, Toxicology Review Branch, DFI, OPMAS, OFCSDSI, HFP, FDA to R. Morissette, RMB, DFI, OPMAS, OFCSDSI, HFP, FDA, April 22, 2025.

List of Subjects in 21 CFR Part 73
Color additives, Cosmetics, Drugs, Foods, Medical devices.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under the authority delegated to the Commissioner of the Food and Drugs, 21 CFR part 73 is amended as follows:

PART 73-LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION
1. The authority citation for part 73 continues to read as follows:

Authority:
21 U.S.C. 321, 341, 342, 343, 348, 351, 352, 355, 361, 362, 371, 379e.
2. Add § 73.80 to read as follows:
§ 73.80
Calcium phosphate.
(a) Identity. (1) The color additive calcium phosphate is a white, synthetically prepared powder consisting predominantly of precipitated Ca 5 OH(PO 4 ) 3.
(2) Color additive mixtures for food use made with calcium phosphate may contain only those diluents that are suitable and are listed in this subpart as safe for use in color additive mixtures for coloring foods.
(b) Specifications. Calcium phosphate must conform to the following specifications and must be free from impurities, other than those named, to the extent that such other impurities may be avoided by good manufacturing practice:
(1) Loss on ignition, not more than 10 percent.
(2) Assay (Ca): 36.0-40.0 percent.
(3) Fluoride, not more than 75 milligrams/kilogram (mg/kg) (75 parts per million (ppm)).
(4) Lead, not more than 0.25 mg/kg (0.25 ppm).
(5) Arsenic, not more than 3 mg/kg (3 ppm).
(c) Uses and restrictions. Calcium phosphate may be safely used for coloring foods intended for human consumption, subject to the following restrictions:
(1) In ready-to-eat chicken products in an amount not exceeding 1.5 percent by weight of the finished food.
(2) In white candy melts in an amount not exceeding 0.25 percent by weight of the finished food.
(3) In doughnut sugar in an amount not exceeding 2.0 percent by weight of the finished food.
(4) In sugar for coated candies in an amount not exceeding 5.25 percent by weight of the finished food.
(d) Labeling requirements. The label of the color additive and any mixtures prepared therefrom intended solely or in part for coloring purposes must conform to the requirements of § 70.25 of this chapter.
(e) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health, and therefore batches thereof are exempt from the certification requirements of section 721(c) of the Federal Food, Drug, and Cosmetic Act.
Dated: May 6, 2025.
Grace R. Graham,

Deputy Commissioner for Policy, Legislation, and International Affairs.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 73
[Docket No. FDA-2024-C-0971]
Listing of Color Additives Exempt From Certification; Butterfly Pea Flower Extract

AGENCY:
Food and Drug Administration, HHS.

ACTION:
Final amendment; order.

SUMMARY:
The Food and Drug Administration (FDA or we) is amending the color additive regulations to provide for the expanded safe use of butterfly pea flower extract as a color additive in ready-to-eat cereals, crackers, snack mixes, hard pretzels, plain potato chips (restructured or baked), and plain corn chips, tortilla chips, and multigrain chips at levels consistent with good manufacturing practice (GMP). This action is in response to a color additive petition (CAP) submitted by Sensient Colors, LLC (Sensient or petitioner).

DATES:
This order is effective June 26, 2025. See section X for further information on the filing of objections. Either electronic or written objections and requests for a hearing on the order must be submitted by June 11, 2025.

ADDRESSES:
You may submit objections and requests for a hearing as follows. Please note that late, untimely filed objections will not be considered. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of June 11, 2025. Objections received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are received on or before that date.

Electronic Submissions
Submit electronic objections in the following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the instructions for submitting comments. Objections submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because your objection will be made public, you are solely responsible for ensuring that your objection does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your objection, that information will be posted on https://www.regulations.gov.
• If you want to submit an objection with confidential information that you do not wish to be made available to the public, submit the objection as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).

Written/Paper Submissions
Submit written/paper submissions as follows:
• Mail/Hand Delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper objections submitted to the Dockets Management Staff, FDA will post your objection, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
Instructions: All submissions received must include the Docket No. FDA-2024-C-0971 for “Listing of Color Additives Exempt from Certification; Butterfly Pea Flower Extract.” Received objections, those filed in a timely manner (see ADDRESSES ), will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
• Confidential Submissions—To submit an objection with confidential information that you do not wish to be made publicly available, submit your objections only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” We will review this copy, including the claimed confidential information, in our consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500.

FOR FURTHER INFORMATION CONTACT:
Stephen DiFranco, Office of Food Chemical Safety, Dietary Supplements, and Innovation, Human Foods Program, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-2710; or Philip Chao, Office of Policy, Regulations, and Information, Human Foods Program, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-2378.

SUPPLEMENTARY INFORMATION:

I. Introduction
In the Federal Register of February 8, 2024 (89 FR 8537), we announced that we filed a color additive petition (CAP 4C0328) submitted by Exponent, Inc., on behalf of Sensient Colors, LLC, 1150 Connecticut Ave. NW, Suite 1100, Washington, DC 20036. The petition proposed to amend the color additive regulations in part 73 (21 CFR 73.69), “Listing of Color Additives Exempt from Certification” to provide for the expanded safe use of butterfly pea flower extract to include ready-to-eat cereals, crackers, snack mixes, hard pretzels, plain potato chips (restructured or baked), and plain corn chips, tortilla chips, and multigrain chips, at levels consistent with GMP.
We note that the notification of filing stated that documents related to this petition would be deposited in docket FDA-2018-C-4117. This petition has been reassigned to a new docket, docket number FDA-2024-C-0971. All relevant files from the previous docket have been moved into docket number FDA-2024-C-0971.
This final order is expected to result in expanded production options and is considered an E.O. 14192 deregulatory action.

II. Background
Butterfly pea flower extract is approved under § 73.69 for coloring alcoholic beverages, sport and energy drinks, flavored or carbonated water, fruit drinks (including smoothies and grain drinks), carbonated soft drinks (fruit-flavored or juice, ginger ale, and root beer), fruit and vegetable juice, nutritional beverages, chewing gum, teas, coated nuts, liquid coffee creamers (dairy and non-dairy), ice cream and frozen dairy desserts, hard candy, dairy and non-dairy drinks, fruit preparations in yogurts, and soft candy in amounts consistent with GMP, except that it may not be used for coloring foods for which standards of identity have been issued under section 401 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), unless the use of added color is authorized by such standards. Butterfly pea flower extract is exempt from certification under section 721(c) of the FD&C Act (21 U.S.C. 379e(c)) because we previously determined that certification was not necessary for the protection of public health (86 FR 49230, September 2, 2021).
The color additive that is the subject of this petition is the dark blue liquid produced through the water extraction of the dried flower petals of Clitoria ternatea, commonly known as the butterfly pea plant. Butterfly pea flower extract contains 42 to 62 percent water, 22 to 43 percent carbohydrates, and 8 to 12 percent proteins. The principal coloring components in butterfly pea flower extract are anthocyanins, mainly delphinidin derivatives (Ref. 1). The extract also contains flavonols, mainly quercetin and kaempferol derivatives, as minor components. Based on data and information provided in this petition (CAP 4C0328) on the identity, physical and chemical properties, manufacturing process, and composition of the color additive, we have determined that the color additive meets the specifications for butterfly pea flower extract in § 73.69 (Ref. 1).

III. Safety Evaluation

A. Determination of Safety
Under section 721(b)(4) of the FD&C Act (21 U.S.C. 379e(b)(4)), a color additive cannot be listed for a particular use unless the data and information available to FDA establish that the color additive is safe for that use. Our color additive regulations at 21 CFR 70.3(i) define “safe” to mean that there is convincing evidence establishing with reasonable certainty that no harm will result from the intended use of the color additive.
To establish with reasonable certainty that a color additive intended for use in food is not harmful under its intended conditions of use, we consider the projected human dietary exposure to the color additive, the additive's toxicological data, and other relevant information (such as published literature) available to us. We compare the estimated dietary exposure of the color additive from all sources to an acceptable daily intake (ADI) level established by toxicological data. The estimated dietary exposure is based on the amount of the color additive proposed for use in particular foods and on data regarding the amount consumed from all sources of the color additive. We commonly use the estimated dietary exposure for the 90th percentile consumer of a color additive as a measure of high chronic dietary exposure.

B. Safety of Petitioned Use of the Color Additive
During our safety review of this petition (CAP 4C0328), we considered the estimated dietary exposure to butterfly pea flower extract, anthocyanins (the main coloring component), total flavonols, and quercetin from the petitioned uses of the subject color additive (Ref. 2). The petition provided the eaters-only 90th percentile dietary exposure for butterfly pea flower extract for the petitioned uses for the U.S. population aged 2 years and older, and various subpopulations. From that dietary exposure and compositional information incorporated by reference from CAP 8C0313, the petitioner also estimated the eaters-only 90th percentile dietary exposure to anthocyanins, total flavonols, and quercetin (Ref. 2).
The petitioner requested that butterfly pea flower extract be permitted at levels consistent with GMP and provided the maximum use levels for the color additive, representing GMP, for the petitioned and approved food uses (Ref. 2). Using food consumption data from the 2015-2018 National Health and Nutrition Examination Survey (NHANES), the petitioner estimated the eaters-only cumulative dietary exposure to butterfly pea flower extract to be 215 milligrams/person/day (mg/p/d) at the mean and 467 mg/p/d at the 90th percentile for the U.S. population aged 2 years and older and 94 mg/p/d at the mean and 183 mg/p/d at the 90th percentile for children aged 2-5 years (Ref. 2).
Assuming a maximum content of 2% anthocyanins (the principal coloring component) in butterfly pea flower extract, the petitioner estimated the eaters-only cumulative dietary exposure to anthocyanins to be 4.3 mg/p/d at the mean and 9.3 mg/p/d at the 90th percentile for the U.S. population aged 2 years and older (Ref. 2). The petitioner also indicated that the color additive could contain up to 3% flavonols and assumed that 50% of the flavonol content was quercetin. Based on these assumptions, the petitioner estimated the eaters-only cumulative dietary exposure to flavonols (6.4 mg/p/d at the mean and 14 mg/p/d at the 90th percentile) and to quercetin (3.2 mg/p/d at the mean and 7 mg/p/d at the 90th percentile) for the U.S. population aged 2 years and older (Ref. 2).
To support the safety of the petitioned uses of butterfly pea flower extract, the petitioner referenced the safety determinations made by FDA for CAP 8C0313 (86 FR 49230, September 2, 2021). The petitioner also conducted an updated search of the peer-reviewed scientific literature on butterfly pea flower extract and Hibiscus sabdariffa flower extract (a known source of anthocyanins with a high content of delphinidin), as well as on other sources of anthocyanins and delphinidins. The petitioner concluded that these publications did not reveal any significant new toxicological effects and should not alter the conclusions of FDA's previous reviews on butterfly pea flower extract. Of the publications submitted by the petitioner, some studies had been previously reviewed by FDA. Our review of the new information, the information submitted in previously reviewed publications, as well as our own independent literature search and review did not reveal any safety concerns relating to the consumption of butterfly pea flower extract or its major components (Ref. 3).
In our most recent evaluation of the use of butterfly pea flower extract as a color additive in various foods (86 FR 49230, September 2, 2021), we did not have any concerns regarding the safety of the use of butterfly pea flower extract and its principal coloring components, anthocyanins and delphinidins. This finding was based on a weight-of-evidence approach and agreed with the petitioner's conclusion that the no observed adverse effect level (NOAEL) in the submitted 90-day study was the highest dose tested (3,500 mg/kg/d of butterfly pea flower extract), which is nearly 500-fold of the estimated 90th percentile dietary exposure for the U.S. population aged 2 years and older from the originally petitioned uses. To establish a reasonable certainty of no harm for the petitioned expanded uses of butterfly pea flower extract, we compared the cumulative estimated dietary exposure to the article of commerce and its constituents in the current petition to that of the previous petition, as well as to the petitioner's NOAEL from their previous 90-day study to develop a margin of exposure (MOE) (Ref. 3). Based on the slight increase in the estimated dietary exposure to butterfly pea flower extract and its constituents resulting from the petitioned expanded uses in this petition above those seen in the previous petition, and the high MOE between the observed NOAEL, we conclude that these new uses of the color additive are reasonably safe under the intended conditions of use (Ref. 3).
We discussed the potential allergenicity of butterfly pea flower extract in our previous approval of a petition for its use in various foods (86 FR 49230, September 2, 2021). We stated that there is no evidence in the scientific literature specifically suggesting that either Clitoria ternatea flowers or the coloring component delphinidin is associated with allergic or hypersensitive reactions. The petitioner submitted an updated search of the peer-reviewed scientific literature and found no new additional publications which suggested an allergenicity concern. Further, to mitigate the possible risk that allergenic proteins and other large peptides might pose, our regulation at 21 CFR 73.69(a)(1) requires that the aqueous extract used to produce the color additive undergo ultrafiltration. Therefore, we concluded that butterfly pea flower extract presents an insignificant allergy risk to consumers of the color additive (Ref. 4).

V. Conclusion
Based on the data and information in the petition, the referenced material, and other relevant material, we conclude that the petitioned use of butterfly pea flower extract as a color additive in ready-to-eat cereals, crackers, snack mixes, hard pretzels, plain potato chips (restructured or baked), and plain corn chips, tortilla chips, and multigrain chips, at levels consistent with GMP is safe. We further conclude that the color additive will achieve its intended technical effect and is suitable for the petitioned uses. Therefore, we are amending the color additive regulations in 21 CFR part 73 as set forth in this document. In addition, based upon the factors listed in 21 CFR 71.20(b), we continue to conclude that batch certification of butterfly pea flower extract is not necessary to protect the public health.

VI. Public Disclosure
In accordance with § 71.15(a) (21 CFR 71.15(a)), the petition and the documents that we considered and relied upon in reaching our decision to approve the petition will be made available for public disclosure (see FOR FURTHER INFORMATION CONTACT ). As provided in § 71.15(b), we will delete from the documents any materials that are not available for public disclosure.

VII. Analysis of Environmental Impact
As stated in the February 8, 2024, Federal Register notification of filing for CAP 4C0328, the petitioner claimed that this action is categorically excluded under § 25.32(k) (21 CFR 25.32(k)) because butterfly pea flower extract would be added directly to food and is intended to remain in the food through ingestion by consumers and is not intended to replace nutrients in food (89 FR 8537 at 8538). We further stated that, if FDA determines a categorical exclusion applies, neither an environmental assessment nor an environmental impact statement is required (id.). We did not receive any new information or comments regarding this claim of categorical exclusion. We considered the petitioner's claim of categorical exclusion and determined that this action is categorically excluded under § 25.32(k). Therefore, neither an environmental assessment nor an environmental impact statement is required.

VIII. Paperwork Reduction Act of 1995
This order contains no collection of information. Therefore, clearance by the Office of Management and Budget under the Paperwork Reduction Act of 1995 is not required.

IX. Section 301(ll) of the FD&C Act
Our review of this petition was limited to section 721 of the FD&C Act. This order is not a statement regarding compliance with other sections of the FD&C Act. For example, section 301(ll) of the FD&C Act (21 U.S.C. 331(ll)) prohibits the introduction or delivery for introduction into interstate commerce of any food that contains a drug approved under section 505 of the FD&C Act (21 U.S.C. 355), a biological product licensed under section 351 of the Public Health Service Act (42 U.S.C. 262), or a drug or biological product for which substantial clinical investigations have been instituted and their existence has been made public, unless one of the exemptions in section 301(ll)(1) through (4) of the FD&C Act applies. In our review of this petition, we did not consider whether section 301(ll) of the FD&C Act or any of its exemptions apply to food containing this color additive. Accordingly, this order should not be construed to be a statement that a food containing this color additive, if introduced or delivered for introduction into interstate commerce, would not violate section 301(ll) of the FD&C Act. Furthermore, this language is included in all orders authorizing new uses of color additives that pertain to food and therefore should not be construed to be a statement of the likelihood that section 301(ll) of the FD&C Act applies.

X. Objections
This order is effective as shown in the DATES section, except as to any provisions that may be stayed by the filing of proper objections. If you will be adversely affected by one or more provisions of this regulation, you may file with the Dockets Management Staff (see ADDRESSES ) either electronic or written objections. You must separately number each objection, and within each numbered objection, you must specify with particularity the provision(s) to which you object, and the grounds for your objection. Within each numbered objection, you must specifically state whether you are requesting a hearing on the particular provision that you specify in that numbered objection. If you do not request a hearing for any particular objection, you waive the right to a hearing on that objection. If you request a hearing, your objection must include a detailed description and analysis of the specific factual information you intend to present in support of the objection in the event that a hearing is held. If you do not include such a description and analysis for any particular objection, you waive the right to a hearing on the objection.
Any objections received in response to the regulation may be seen in the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at https://www.regulations.gov. We will publish notice of the objections that we have received or lack thereof in the Federal Register .

XI. References
The following references are on display at the Dockets Management Staff (see ADDRESSES ) and are available for viewing by interested persons between 9 a.m. and 4 p.m., Monday through Friday; they are also available electronically at https:// www.regulations.gov. FDA has verified the website addresses, as of the date this document publishes in the Federal Register , but websites are subject to change over time.
1. Memorandum from B. Petigara-Harp, Color Technology Branch, Division of Color Certification and Technology, Office of Cosmetics and Colors (OCAC), Office of Commissioner, Office of Chief Scientist, FDA to S. DiFranco, Regulatory Management Branch (RMB), Division of Food Ingredients (DFI), Office of Pre-market Additive Safety (OPMAS), HFP, FDA, April 21, 2025.
2. Memorandum from H. Thapa, Chemistry Evaluation Branch, DFI, OPMAS, HFP, FDA to S. DiFranco, RMB, DFI, OPMAS, HFP, FDA, April 21, 2025.
3. Memorandum from T. Thurmond, Toxicology Review Branch (TRB), DFI, OPMAS, HFP, FDA to S. DiFranco, RMB, DFI, OPMAS, HFP, FDA, April 21, 2025.
4. Memorandum from Y. Zang, Toxicology Review Team, DFI, Office of Food Additive Safety (OFAS), Center for Food and Human Nutrition (CFSAN), FDA, to S. DiFranco, DFI, OFAS, CFSAN, FDA, June 9, 2021.

List of Subjects in 21 CFR Part 73
Color additives, Cosmetics, Drugs, Foods, Medical devices.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under the authority delegated to the Commissioner of the Food and Drugs, 21 CFR part 73 is amended as follows:

PART 73-LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION
1. The authority citation for part 73 continues to read as follows:

Authority:
21 U.S.C. 321, 341, 342, 343, 348, 351, 352, 355, 361, 362, 371, 379e.
2. Section 73.69 is amended by revising paragraph (c) to read as follows:
§ 73.69
Butterfly pea flower extract.
* * * * *
(c) Uses and restrictions. Butterfly pea flower extract may be safely used for coloring alcoholic beverages, sport and energy drinks, flavored or carbonated water, fruit drinks (including smoothies and grain drinks), carbonated soft drinks (fruit-flavored or juice, ginger ale, and root beer), fruit and vegetable juice, nutritional beverages, chewing gum, teas, coated nuts, liquid coffee creamers (dairy and non-dairy), ice cream and frozen dairy desserts, hard candy, dairy and non-dairy drinks, fruit preparations in yogurts, soft candy, ready-to-eat cereals, crackers, snack mixes, hard pretzels, plain potato chips (restructured or baked), and plain corn chips, tortilla chips, and multigrain chips. Amounts must be consistent with good manufacturing practice. Butterfly pea flower extract may not be used for coloring foods for which standards of identity have been issued under section 401 of the Federal Food, Drug, and Cosmetic Act, unless the use of added color is authorized by such standards.
* * * * *
Dated: May 6, 2025.
Grace R. Graham,

Deputy Commissioner for Policy, Legislation, and International Affairs.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 73
[Docket No. FDA-2021-C-0925]
Listing of Color Additives Exempt From Certification; Galdieria Extract Blue

AGENCY:
Food and Drug Administration, HHS.

ACTION:
Final amendment; order.

SUMMARY:
The Food and Drug Administration (FDA or we) is amending the color additive regulations to provide for the safe use of galdieria extract blue, derived from unicellular red algae ( Galdieria sulphuraria ), in various food categories at levels consistent with good manufacturing practice (GMP). We are taking this action in response to a color additive petition (CAP) submitted by Fermentalg (Fermentalg or petitioner).

DATES:
This order is effective June 26, 2025. See section XI of this document for further information on the filing of objections. Either electronic or written objections and requests for a hearing on the order must be submitted by June 11, 2025.

ADDRESSES:
You may submit objections and requests for a hearing as follows. Please note that late, untimely filed objections will not be considered. The https://www.regulations.gov electronic filing system will accept objections until 11:59 p.m. Eastern Time at the end of June 11, 2025. Objections received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are received on or before that date.

Electronic Submissions
Submit electronic objections in the following way:
• Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Objections submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because your objection will be made public, you are solely responsible for ensuring that your objection does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your objection, that information will be posted on https://www.regulations.gov.
• If you want to submit an objection with confidential information that you do not wish to be made available to the public, submit the objection as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).

Written/Paper Submissions
Submit written/paper submissions as follows:
• Mail/Hand Delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper objections submitted to the Dockets Management Staff, FDA will post your objection, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
Instructions: All submissions received must include the Docket No. FDA-2021-C-0925 for “Listing of Color Additives Exempt from Certification; Galdieria Extract Blue.” Received objections, those filed in a timely manner (see ADDRESSES ), will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
• Confidential Submissions—To submit an objection with confidential information that you do not wish to be made publicly available, submit your objections only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” We will review this copy, including the claimed confidential information, in our consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts, and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500.

FOR FURTHER INFORMATION CONTACT:
Stephanie A. Hice, Office of Food Chemical Safety, Dietary Supplements, and Innovation, Human Foods Program, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 301-348-1740 or Keronica Richardson, Office of Policy, Regulations, and Information, Human Foods Program, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-2378.

SUPPLEMENTARY INFORMATION:

I. Introduction
In the Federal Register of September 9, 2021 (86 FR 50495), FDA announced that we filed a color additive petition (CAP 1C0320) submitted by Fermentalg, 4 Rue Rivière, 33500 Libourne, France. The petition proposed that FDA amend the color additive regulations in part 73 (21 CFR part 73), “Listing of Color Additives Exempt from Certification,” to provide for the safe use of galdieria extract blue as a color additive at levels consistent with GMP in: non-alcoholic beverages and beverage bases, fruit drinks, fruit smoothies, fruit juices, vegetable juices, dairy-based smoothies, milk shakes and flavored milks, yogurt drinks, milk-based meal replacement and nutritional beverages, breakfast cereal coatings, hard candy, soft candy and chewing gum, flavored frostings, ice cream and frozen dairy desserts, frozen fruits, water ices and popsicles, gelatin desserts, puddings and custards, whipped cream, yogurt, frozen or liquid creamers (including non-dairy alternatives), and whipped toppings (including non-dairy alternatives). (In the filing notice for CAP 1C0320, the color additive was called “blue galdieria extract.” After the filing notice was published, the name was changed to “galdieria extract blue.”)

II. Background
Galdieria extract blue is a blue liquid or powder prepared from the aqueous extraction of the dried biomass of Galdieria sulphuraria, a naturally occurring species of red microalgae. Galdieria extract blue contains C-phycocyanin, the principal coloring component, and may contain authorized food-grade carriers and antioxidants to standardize the color intensity and stabilize the color additive.
Production of the G. sulphuraria biomass is carried out by heterotrophic fermentation with no reported instances of pathogenicity or toxigenicity. The petitioner states that the production strain was deposited in the Culture Collection of Algae and Protozoa, Scottish Marine Institute, in Dunbeg, Oban, Scotland. Using a fed-batch or continuous process for providing the fermentation medium, the production strain is contained in an enclosed fermentation vessel, which avoids potential contamination by bacteria, cyanobacteria, fungi, or environmental contaminants such as heavy metals and pesticides that could otherwise be encountered in open ponds.
The finished biomass is concentrated, washed with water to remove the majority of culture medium and antifoam agent, mechanically lysed, and subjected to extraction with water, which results in a crude extract. The crude extract consists of a mixture of C-phycocyanin and other water-soluble proteins, minerals, and carbohydrates, which is then treated with a carbohydrase enzyme that digests the carbohydrates. The resulting extract is purified with consecutive filtrations and can be in a liquid form, or in a powdered form using spray-drying or other drying technologies (Ref. 1).
The petitioner proposed the following specifications for galdieria extract blue: lead, not more than 0.5 milligram/kilogram (mg/kg) (0.5 part per million (ppm)); cadmium, not more than 1 mg/kg (1 ppm); arsenic, not more than 0.5 mg/kg (0.5 ppm); mercury, not more than 0.05 mg/kg (0.05 ppm). FDA has determined that the petitioner's data support that lead, cadmium, and arsenic should all have a specification of not more than 0.5 mg/kg. The petitioner's data support a specification of not more than 0.05 mg/kg for mercury (Ref. 1).

III. Safety Evaluation
Under section 721(b)(4) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 379e(b)(4)), a color additive may not be listed for a proposed use unless the data and other information available to FDA establish that the color additive is safe for that use. Our color additive regulations at 21 CFR 70.3(i) define “safe” to mean that there is convincing evidence establishing with reasonable certainty that no harm will result from the intended use of the color additive.
To determine whether a color additive is safe under the general safety clause, the FD&C Act requires FDA to conduct a fair evaluation of the available data and consider, among other relevant factors: (1) probable consumption of, or other relevant exposure from, the additive and of any substance formed in or on food, drugs, devices, or cosmetics because of the use of the additive; (2) cumulative effect, if any, of such additive in the diet of man or animals, taking into account chemically or pharmacologically related substance or substances in such diet; and (3) safety factors recognized by experts as appropriate for the use of animal experimentation data (see section 721(b)(5)(A)(i) through (iii) of the FD&C Act).
As part of our safety evaluation to establish with reasonable certainty that a color additive is not harmful under its intended conditions of use, we consider the additive's manufacturing and stability, the projected human dietary exposure to the additive and any impurities resulting from the petitioned use of the additive, the additive's toxicological data, and other relevant information (such as published literature) available to us.

IV. Safety of the Petitioned Use of the Color Additive

A. Dietary Exposure Estimate
The petitioner provided information on the proposed food categories and the corresponding maximum use levels of galdieria extract blue as a color additive that represent levels consistent with GMP for each proposed food category (Ref. 2). The petitioner used food consumption data from the 2017-2018 National Health and Nutrition Examination Survey (NHANES) to estimate the dietary exposure to galdieria extract blue from the petitioned uses. The petitioner estimated the eaters-only ( i.e., only those individuals in the population that consume the foods of interest) dietary exposure to galdieria extract blue to be 273 mg/person/day (mg/p/d) at the mean and 630 mg/p/d at the 90th percentile for the U.S. population aged 2 years and older; and 261 mg/p/d at the mean and 575 mg/p/d at the 90th percentile for children aged 2-5 years (Ref. 2).
The petitioner indicated that the typical level of C-phycocyanin in galdieria extract blue is 34 percent. FDA estimated the dietary exposure to C-phycocyanin by multiplying the dietary exposure to galdieria extract blue by the typical C-phycocyanin level of 34 percent, resulting in an estimated eaters-only dietary exposure to the principal coloring component from the petitioned uses to be 93 mg/p/d at the mean and 214 mg/p/d at the 90th percentile for the U.S. population aged 2 years and older; and 89 mg/p/d at the mean and 196 mg/p/d at the 90th percentile for children aged 2-5 years (Ref. 2).
The petitioner stated that galdieria extract blue will likely be used in the petitioned food categories as a substitute for spirulina extract, a related C-phycocyanin-based color additive derived from Arthrospira platensis. Given that galdieria extract blue will likely be used in the petitioned food categories as a substitute for spirulina extract, and given the structural similarity of the phycocyanobilin chromophores in these two sources, we would not expect an increase in the current upper-bound cumulative estimated daily intake (CEDI) for C-phycocyanin of 1140 mg/p/d in the U.S. diet from the petitioned uses of galdieria extract blue. Therefore, the current upper-bound CEDI of C-phycocyanin encompasses the petitioned uses of galdieria extract blue (Ref. 2).

B. Toxicological Considerations
To support the safety of the petitioned use of galdieria extract blue, the petitioner provided peer-reviewed studies, data derived from publicly available databases, and referenced previously submitted color additive petitions. The data and information provided included: (1) the results of a subchronic (90-day rat) toxicology study on the G. sulphuraria C-phycocyanin extract and the G. sulphuraria biomass, (2) two genotoxicity assays (bacterial reverse mutation test and in vitro micronucleus test), (3) a safety narrative that discusses the results of their safety assessment of the color additive, (4) a narrative that discusses the current published literature that supports the safe use of the color additive, and (5) a discussion on FDA's previous reviews of color additive petitions regarding the safety of C-phycocyanin (78 FR 49117, August 13, 2013; 79 FR 20095, April 11, 2014; 82 FR 30731, July 3, 2017). The petitioner also addressed the potential for allergenicity associated with the color additive (Ref. 3).
The petitioner included data from a 90-day subchronic study that used multiple doses of galdieria extract blue. The study also included a post-treatment recovery period of 28 days to facilitate evaluation of the persistence, reversibility, or delayed occurrence of toxic effects. C-phycocyanin extract derived from Spirulina platensis (reclassified as A. platensis ) was used as a reference test item, for a period of 90 days with the same dosing procedure as for galdieria extract blue. The petitioner reported no instances of mortality among the animals treated with galdieria extract blue or C-phycocyanin extract derived from A. platensis throughout the study. All control animals and treated animals survived during the treatment period of 90 days and during the 28-day recovery period. No gross treatment-related changes were observed at necropsy. FDA identified no major deficiencies that would invalidate the study results for its intended purpose, and no results from this study suggest that galdieria extract blue produces adverse effects for any of the parameters evaluated during the study. The petitioner concluded that under the test conditions, the no observed adverse effect level (NOAEL) for galdieria extract blue was the highest dose tested, 4000 mg/kg body weight (bw)/d (Ref. 3).
The petitioner also included data from a 90-day subchronic study that used multiple doses of the G. sulphuraria biomass. Following completion of the study, the petitioner stated that the G. sulphuraria biomass was well-tolerated at all dose levels with no mortality or toxicity observed. The petitioner concluded that under the test conditions, the NOAEL for the G. sulphuraria biomass was the highest dose tested, 5000 mg/kg bw/d (Ref. 3).
An Ames test (bacterial reverse mutation test) and an in vitro micronucleus test were also conducted on both galdieria extract blue and the G. sulphuraria biomass. Following completion of the studies, the petitioner concluded that the test items did not show any mutagenic activity in the Ames test, and that the in vitro micronucleus test demonstrated no statistically significant increase in micronucleated cells. Based on the data submitted by the petitioner, FDA agrees with the petitioner's findings that galdieria extract blue was not a mutagen in the Ames test under the conditions of the assay, nor did it induce chromosomal damage under the conditions of the micronucleus test.
The petitioner's discussion of the potential allergenicity of C-phycocyanin included a pepsin gastric simulation assay, a bioinformatics analysis of potential proteins encoded in the genome DNA of G. sulphuraria that could be associated with allergenicity, and the results of petitioner's literature search. The results of the pepsin gastric simulation assay indicated that C-phycocyanin derived from G. sulphuraria is likely to undergo rapid degradation under normal digestive conditions, suggesting that it may be non-allergenic. The results of the bioinformatic analysis only identified sequences from highly conserved gene families, and these sequences demonstrated lower similarity to G. sulphuraria proteins than to members of the same gene family in common foodstuffs. Therefore, the color additive is proposed to have low allergenic risk. The petitioner's literature search identified one case report of an atopic person having an anaphylactic reaction to C-phycocyanin derived from A. platensis. The petitioner considered the response to be idiosyncratic; no other reports of a similar reaction to C-phycocyanin were identified. Given the results of the pepsin gastric simulation assay, the bioinformatic analysis, and the search of the literature, we concur with the petitioner's conclusion that galdieria extract blue is unlikely to produce an allergic reaction and find no additional data suggesting galdieria extract blue is associated with allergic or hypersensitivity reactions (Ref. 3).
The petitioner's safety narrative included a structural comparison of C-phycocyanin from G. sulphuraria and C-phycocyanin from A. platensis, noting that C-phycocyanins from G. sulphuraria and A. platensis belong to the same C-phycocyanin family and stated that their primary sequences of the protein backbone are highly similar, with no significant differences between their 3-dimensional organizations. The petitioner stated that, despite amino acid differences between the two C-phycocyanins, the differences did not seem to affect any of the molecular recognition properties of the C-phycocyanins, neither in their structural organization nor in the chromophore binding, and therefore, the functional properties are likely to be similar (Ref. 3).
Based on our review of the safety data provided by the petitioner, and our independent review of the current published literature, which do not present evidence of safety concerns for galdieria extract blue at the expected dietary exposures, and given that the estimated 90th percentile dietary exposure for the color additive for the U.S. population aged 2 years and older (630 mg/p/d) does not exceed the NOAEL of 4000 mg/kg bw/d, we conclude that galdieria extract blue is safe for the petitioned uses.

VI. Conclusion
Based on the data and information in the petition and other available relevant information, we conclude that the petitioned use of galdieria extract blue as a color additive in non-alcoholic beverages and beverage bases, fruit drinks, fruit smoothies, fruit juices, vegetable juices, dairy-based smoothies, milk shakes and flavored milks, yogurt drinks, milk-based meal replacement and nutritional beverages, breakfast cereal coatings, hard candy, soft candy and chewing gum, flavored frostings, ice cream and frozen dairy desserts, frozen fruits, water ices and popsicles, gelatin desserts, puddings and custards, whipped cream, yogurt, frozen or liquid creamers (including non-dairy alternatives), and whipped toppings (including non-dairy alternatives) is safe, provided the amount of galdieria extract blue does not exceed levels consistent with GMP.
We further conclude that this color additive will achieve its intended technical effect and is suitable for the petitioned use. Therefore, we are amending the color additive regulations in part 73 to provide for the safe use of this color additive as set forth in this document. In addition, based on the factors in 21 CFR 71.20(b), we conclude that batch certification of galdieria extract blue is not necessary to protect the public health.
This final order is expected to result in expanded production options and is considered an E.O. 14192 deregulatory action.

VII. Public Disclosure
In accordance with § 71.15 (21 CFR 71.15), the petition and the documents that we considered and relied upon in reaching our decision to approve the petition will be made available for public disclosure (see FOR FURTHER INFORMATION CONTACT ). As provided in § 71.15, we will delete from the documents any materials that are not available for public disclosure.

VIII. Analysis of Environmental Impact
As we stated in the September 9, 2021, Federal Register notification of petition for CAP 1C0320 (86 FR 50495 at 50495 to 50496), the petitioner claimed that this action is categorically excluded under § 25.32(r) (21 CFR 25.32(r)) because the substance occurs naturally in the environment, and the proposed action does not significantly alter the concentration or distribution of the substance, its metabolites, or degradation products in the environment, and that, to their knowledge, no extraordinary circumstances exist that would warrant at least an environmental assessment (see § 25.21 (21 CFR 25.21)). We did not receive any new information or comments regarding this claim of categorical exclusion. We considered the petitioner's claim of categorical exclusion and determined that this action is categorically excluded under § 25.32(r). Therefore, neither an environmental assessment nor an environmental impact statement is required.

IX. Paperwork Reduction Act of 1995
This order contains no collection of information. Therefore, clearance by the Office of Management and Budget under the Paperwork Reduction Act of 1995 is not required.

X. Section 301(ll) of the FD&C Act
Our review of this petition was limited to section 721 of the FD&C Act (21 U.S.C. 379e). This order is not a statement regarding compliance with other sections of the FD&C Act. For example, section 301(ll) of the FD&C Act (21 U.S.C. 331(ll)) prohibits the introduction or delivery for introduction into interstate commerce of any food that contains a drug approved under section 505 of the FD&C Act (21 U.S.C. 355), a biological product licensed under section 351 of the Public Health Service Act (42 U.S.C. 262), or a drug or biological product for which substantial clinical investigations have been instituted and their existence has been made public, unless one of the exemptions in section 301(ll)(1) to (4) of the FD&C Act applies. In our review of this petition, we did not consider whether section 301(ll) of the FD&C Act or any of its exemptions apply to food containing this color additive. Accordingly, this order should not be construed to be a statement that a food containing this color additive, if introduced or delivered for introduction into interstate commerce, would not violate section 301(ll) of the FD&C Act. Furthermore, this language is included in all color additive final orders that pertain to food and therefore should not be construed to be a statement of the likelihood that section 301(ll) of the FD&C Act applies.

XI. Objections
This order is effective as shown in the DATES section, except as to any provisions that may be stayed by the filing of proper objections. If you will be adversely affected by one or more provisions of this regulation, you may file with the Dockets Management Staff (see ADDRESSES ) either electronic or written objections. You must separately number each objection, and within each numbered objection you must specify with particularity the provision(s) to which you object, and the grounds for your objection. Within each numbered objection, you must specifically state whether you are requesting a hearing on the particular provision that you specify in that numbered objection. If you do not request a hearing for any particular objection, you waive the right to a hearing on that objection. If you request a hearing, your objection must include a detailed description and analysis of the specific factual information you intend to present in support of the objection in the event that a hearing is held. If you do not include such a description and analysis for any particular objection, you waive the right to a hearing on the objection.
Any objections received in response to the regulation may be seen in the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at https://www.regulations.gov. We will publish notice of the objections that we have received or lack thereof in the Federal Register .

XII. References
The following references are on display at the Dockets Management Staff (see ADDRESSES ) and are available for viewing by interested persons between 9 a.m. and 4 p.m., Monday through Friday; they are also available electronically at https://www.regulations.gov. FDA has verified the website addresses, as of the date this document publishes in the Federal Register , but websites are subject to change over time.
1. Memorandum from N. Belai, Color Technology Branch, Division of Color Certification and Technology, Office of Cosmetics and Colors, Office of the Chief Scientist, FDA to S. Hice, Innovative Foods Staff (IFS), Office of Food Chemical Safety, Dietary Supplements, and Innovation (OFCSDSI), Human Foods Program (HFP), FDA, April 28, 2025.
2. Memorandum from H. Lee, Chemistry Evaluation Branch, DFI, Office of Pre-Market Additive Safety (OPMAS), OFCSDSI, HFP, FDA to S. Hice, IFS, OFCSDSI, HFP, FDA, April 28, 2025.
3. Memorandum from S. Thurmond, Toxicology Review Branch, DFI, OPMAS, OFCSDSI, HFP, FDA to S. Hice, IFS, OFCSDSI, HFP, FDA, April 28, 2025.

List of Subjects in 21 CFR Part 73
Color additives, Cosmetics, Drugs, Foods, Medical devices.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under the authority delegated to the Commissioner of Food and Drugs, 21 CFR part 73 is amended as follows:

PART 73—LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION
1. The authority citation for part 73 continues to read as follows:

Authority:
21 U.S.C. 321, 341, 342, 343, 348, 351, 352, 355, 361, 362, 371, 379e.
2. Add § 73.167 to subpart A to read as follows:
§ 73.167
Galdieria extract blue.
(a) Identity. (1) The color additive galdieria extract blue is a liquid or powder prepared by the filtered aqueous extraction of the dried biomass of a non-pathogenic and non-toxigenic strain of Galdieria sulphuraria. The biomass is prepared by heterotrophic fermentation of G. sulphuraria. The color additive contains C-phycocyanin as the principal coloring component.
(2) Color additive mixtures for food use made with galdieria extract blue may contain only those diluents that are suitable and are listed in this subpart as safe for use in color additive mixtures for coloring foods.
(b) Specifications. Galdieria extract blue must conform to the following specifications and must be free from impurities, other than those named, to the extent that such other impurities may be avoided by good manufacturing practice:
(1) Lead, not more than 0.5 milligram/kilogram (mg/kg) (0.5 parts per million (ppm)).
(2) Arsenic, not more than 0.5 mg/kg (0.5 ppm).
(3) Mercury, not more than 0.05 mg/kg (0.05 ppm).
(4) Cadmium, not more than 0.5 mg/kg (0.5 ppm).
(c) Uses and restrictions. Galdieria extract blue may be safely used for coloring non-alcoholic beverages and beverage bases, fruit drinks, fruit smoothies, fruit juices, vegetable juices, dairy-based smoothies, milk shakes and flavored milks, yogurt drinks, milk-based meal replacement and nutritional beverages, breakfast cereal coatings, hard candy, soft candy and chewing gum, flavored frostings, ice cream and frozen dairy desserts, frozen fruits, water ices and popsicles, gelatin desserts, puddings and custards, whipped cream, yogurt, frozen or liquid creamers (including non-dairy alternatives), and whipped toppings (including non-dairy alternatives), at levels consistent with good manufacturing practice, except that it may not be used to color foods for which standards of identity have been issued under section 401 of the Federal Food, Drug, and Cosmetic Act, unless the use of the added color is authorized by such standards.
(d) Labeling. The label of the color additive and of any mixture prepared therefrom intended solely or in part for coloring purposes must conform to the requirements of § 70.25 of this chapter.
(e) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health, and therefore batches thereof are exempt from the certification requirements of section 721(c) of the Federal Food, Drug, and Cosmetic Act.
Dated: May 6, 2025.
Grace R. Graham,

Deputy Commissioner for Policy, Legislation, and International Affairs.
DEPARTMENT OF HOMELAND SECURITY
Coast Guard
33 CFR Part 165
[Docket Number USCG-2025-0321]
RIN 1625-AA00
Safety Zone; Atlantic Ocean, Cocoa Beach, FL

AGENCY:
Coast Guard, Department of Homeland Security (DHS).

ACTION:
Temporary final rule.

SUMMARY:
The Coast Guard is establishing a temporary safety zone for certain waters of the Atlantic Ocean near Cocoa Beach, Florida. This safety zone is needed to protect personnel, vessels, and the marine environment from potential hazards associated with the Thunder on Cocoa Beach powerboat racing event. Entry of vessels or persons into this zone is prohibited unless specifically authorized by the Captain of the Port Jacksonville or a designated representative.

DATES:
This rule is effective daily from 8 a.m. until 6:30 p.m. on May 16, 2025, through May 18, 2025.

ADDRESSES:
To view documents mentioned in this preamble as being available in the docket, go to https://www.regulations.gov, type USCG-2025-0321 in the search box and click “Search.” Next, in the Document Type column, select “Supporting & Related Material.”

FOR FURTHER INFORMATION CONTACT:
If you have questions about this rule, call or email Marine Safety Technician First Class Alex Christensen, Marine Safety Unit Port Canaveral, U.S. Coast Guard; telephone 321-868-5921, email alex.m.christensen@uscg.mil.

SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations
CFR Code of Federal Regulations
COTP Captain of the Port
DHS Department of Homeland Security
FR Federal Register
NPRM Notice of proposed rulemaking
§ Section
U.S.C. United States Code

II. Background Information and Regulatory History
The Coast Guard is issuing this temporary rule under the authority in 5 U.S.C. 553(b)(B). This statutory provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” The Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule because it is impracticable. The Coast Guard lacks sufficient time to provide for a comment period and then consider those comments before issuing the rule since this rule is needed by May 16, 2025. We must establish the safety zone by May 16, 2025, to ensure the safety of the public, and vessels transiting the waters of the Atlantic Ocean near Cocoa Beach, Florida during the race event.
Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the Federal Register . Delaying the effective date of this rule would be impracticable and contrary to the public interest because prompt action is needed to respond to the potential dangers to the public and vessels during the race.

III. Legal Authority and Need for Rule
The Coast Guard is issuing this rule under authority in 46 U.S.C. 70034. The Captain of the Port (COTP) Jacksonville has determined that potential hazards associated with Thunder on Cocoa Beach powerboat races will be a safety concern for anyone within the described boundary of this safety zone. This rule is needed to protect personnel, vessels, and the marine environment in the navigable waters within the safety zone while the event is taking place.

IV. Discussion of the Rule
This rule establishes a safety zone daily from 8 a.m. until 6:30 p.m. on May 16, 2025, through May 18, 2025. The safety zone will cover all navigable waters within a set boundary located in the Atlantic Ocean off the coast of Cocoa Beach, FL. The duration of the zone is intended to protect personnel, vessels, and the marine environment in these navigable waters during this event. No vessel or person will be permitted to enter the safety zone without obtaining permission from the COTP Jacksonville or a designated representative. A designated representative is a commissioned, warrant, or petty officer of the Coast Guard assigned to units under the operational control of the Coast Guard Sector Jacksonville. Requests for entry will be considered and reviewed on a case-by-case basis.
Persons and vessels may request authorization to enter, transit through, anchor in, or remain within the regulated area by contacting the Captain of the Port Jacksonville or a designated representative via VHF radio on channel 16. If authorization to enter, transit through, anchor in, or remain within the regulated area is granted by the Captain of the Port Jacksonville or a designated representative, all persons and vessels receiving such authorization must comply with the instructions of the Captain of the Port Jacksonville or a designated representative. The Coast Guard will provide notice of the safety zone by Broadcast Notice to Mariners via VHF-FM marine channel 16, and/or by on-scene designated representatives.

V. Regulatory Analyses
We developed this rule after considering numerous statutes and Executive orders related to rulemaking. Below we summarize our analyses based on a number of these statutes and Executive orders.

A. Regulatory Planning and Review
Executive Orders 12866 and 13563 direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits. This rule has not been designated a “significant regulatory action,” under section 3(f) of Executive Order 12866. Accordingly, this rule has not been reviewed by the Office of Management and Budget (OMB).
This regulatory action determination is based on: (1) This rule involves a safety zone that will prohibit persons and vessels from entering, transiting through, anchoring in, or remaining within a limited area on the navigable waters of Cocoa Beach, Florida, during a racing event lasting ten and a half hours daily for three days; (2) Although persons and vessels may not enter, transit through, anchor in, or remain within the zone without authorization from the COTP or a designated representative, they will be able to safely transit around this safety zone; (3) persons and vessels may still enter, transit through, anchor in, or remain within the areas during the enforcement period if authorized by the COTP or a designated representative; and (4) the Coast Guard will provide advance notification of the zone to the local maritime community by Broadcast Notice to Mariners, or by on-scene designated representatives.

B. Impact on Small Entities
The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as amended, requires Federal agencies to consider the potential impact of regulations on small entities during rulemaking. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities.
While some owners or operators of vessels intending to transit the safety zone may be small entities, for the reasons stated in section V.A. above, this rule will not have a significant economic impact on any vessel owner or operator.
Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding this rule. If the rule will affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please call or email the person listed in the FOR FURTHER INFORMATION CONTACT section.
Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247). The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard.

C. Collection of Information
This rule will not call for a new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

D. Federalism and Indian Tribal Governments
A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on the States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government. We have analyzed this rule under that order and have determined that it is consistent with the fundamental federalism principles and preemption requirements described in Executive Order 13132.
Also, this rule does not have Tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect on one or more Indian Tribes, on the relationship between the Federal Government and Indian Tribes, or on the distribution of power and responsibilities between the Federal Government and Indian Tribes.

E. Unfunded Mandates Reform Act
The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or Tribal government, in the aggregate, or by the private sector of $100,000,000 (adjusted for inflation) or more in any one year. Though this rule will not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble.

F. Environment
We have analyzed this rule under Department of Homeland Security Directive 023-01, Rev. 1, associated implementing instructions, and Environmental Planning COMDTINST 5090.1 (series), which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have determined that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule involves a safety zone lasting only ten and a half hours each day over a three-day period that will prohibit entry within a described boundary off the coast of Cocoa Beach, FL. It is categorically excluded from further review under paragraph L60(a) of Appendix A, Table 1 of DHS Instruction Manual 023-01-001-01, Rev. 1. A Record of Environmental Consideration supporting this determination is available in the docket. For instructions on locating the docket, see the ADDRESSES section of this preamble.

List of Subjects in 33 CFR Part 165
Harbors, Marine safety, Navigation (water), Reporting and recordkeeping requirements, Security measures, Waterways.
For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 165 as follows:

PART 165—REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS
1. The authority citation for part 165 continues to read as follows:

Authority:
46 U.S.C. 70034, 70051, 70124; 33 CFR 1.05-1, 6.04-1, 6.04-6, and 160.5; Department of Homeland Security Delegation No. 00170.1, Revision No. 01.3.
2. Add § 165.T07-0321 to read as follows:
§ 165.T07-0321
Safety Zone; Atlantic Ocean, Cocoa Beach, FL.
(a) Location. The following area is a safety zone: All waters of the Atlantic Ocean, from surface to bottom, encompassed by a line connecting the following points beginning at 28°18.688′ N, 80°36.345′ W, thence to 28°18.685′ N, 80°35.617′ W, thence to 28°22.143′ N, 80° 35.225′ W, thence to28°22.330′ N, 80°35.996′ W, thence back to the beginning point. These coordinates are based on the 1984 World Geodetic System (WGS 84).
(b) Definitions. As used in this section, designated representative means a Coast Guard Patrol Commander, including a Coast Guard coxswain, petty officer, or other officer operating a Coast Guard vessel and a Federal, State, and local officer designated by or assisting the Captain of the Port (COTP) Jacksonville in the enforcement of the safety zone.
(c) Regulations. (1) Under the general safety zone regulations in subpart C of this part, you may not enter the safety zone described in paragraph (a) of this section unless authorized by the COTP Jacksonville or designated representative.
(2) Designated representatives may control vessel traffic throughout the enforcement area as determined by the prevailing conditions.
(3) To seek authorization to enter, contact the COTP or the COTP's representative by telephone at (904) 714-7557, or an on-scene designated representative via VHF-FM radio on channel 16. If authorization is granted, all persons and vessels receiving such authorization must comply with the instructions of the COTP Jacksonville or a designated representative.
(d) Enforcement period. The safety zone will be enforced daily, from 8 a.m. to 6:30 p.m., from May 16, 2025, through May 18, 2025. The Coast Guard will provide notice of the regulated area by Broadcast Notice to Mariners on VHF-FM marine channel 16.
J.D. Espino-Young,

Captain, U.S. Coast Guard, Captain of the Port Sector Jacksonville.
DEPARTMENT OF COMMERCE
National Oceanic and Atmospheric Administration
50 CFR Part 217
[Docket No. 250505-0077]
RIN 0648-BN12
Takes of Marine Mammals Incidental to Specified Activities; Taking Marine Mammals Incidental to the Lower Columbia River Dredged Material Management Plan, Oregon and Washington

AGENCY:
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.

ACTION:
Final rule.

SUMMARY:
NMFS, upon request from the U.S. Army Corps of Engineers (USACE), issues regulations to govern the unintentional taking of marine mammals incidental to implementation of the Lower Columbia River Dredged Material Management Plan in Oregon and Washington over 5 years (2027-2032). These regulations, which allow for the issuance of a Letter of Authorization (LOA) for the incidental take of marine mammals during the specified activities and timeframes, prescribe the permissible methods of taking and effecting the least practicable adverse impact on marine mammal species or stocks and their habitat, as well as monitoring and reporting requirements.

DATES:
This rule is effective from November 1, 2027 through February 29, 2032.

ADDRESSES:
A copy of the USACE's application and any supporting documents, as well as a list of the references cited in this document, may be obtained online at: https://www.fisheries.noaa.gov/action/incidental-take-authorization-us-army-corps-engineers-lower-columbia-river-dredged-material.
In case of problems accessing these documents, please call the contact listed below.

FOR FURTHER INFORMATION CONTACT:
Robert Pauline, Office of Protected Resources, NMFS, (301) 427-8401.

SUPPLEMENTARY INFORMATION:

Purpose and Need for Regulatory Action
This rule establishes a framework under the authority of the Marine Mammal Protection Act (MMPA) (16 U.S.C. 1361 et seq. ) to allow for the authorization of take of marine mammals incidental to the USACE's construction activities related to the Lower Columbia River (LCR) Dredged Materials Management Plan (DMMP).
We received an application from the USACE requesting 5-year regulations and authorization to take multiple species of marine mammals. Take is anticipated to occur incidental to impact and vibratory pile driving, by Level A and Level B harassment only. Please see Background below for definitions of harassment.

Legal Authority for the Action
Section 101(a)(5)(A)(i) of the MMPA (16 U.S.C. 1371(a)(5)(A)(i)) directs the Secretary of Commerce to allow, upon request, the incidental, but not intentional, taking of small numbers of marine mammals by U.S. citizens who engage in a specified activity (other than commercial fishing) within a specified geographical region for up to 5 years if, after notice and public comment, the agency “finds that the total of such taking during each . . . period concerned will have a negligible impact on such species or stock and will not have an unmitigable adverse impact on the availability of such species or stock for taking for subsistence uses” and issues regulations that set forth “permissible methods of taking pursuant to that activity, and other means of effecting the least practicable adverse impact on [the affected] species or stock and their habitat” as well as monitoring and reporting requirements. As such, this provision of the MMPA and the implementing regulations at 50 CFR 216.105 and 216.106 provides the legal basis for issuing this rule containing 5-year regulations and for any subsequent LOAs.

Summary of Major Provisions
The major provisions of this final rule include:
• Monitoring of the construction areas to detect the presence of marine mammals before beginning construction activities;
• Shutdown of construction activities under certain circumstances to avoid injury of marine mammals;
• Soft start for impact pile driving to allow marine mammals the opportunity to leave the area prior to beginning impact pile driving at full power; and
• Use of bubble curtains to attenuate sound levels when impact pile driving.

Legal Background
The MMPA prohibits the “take” of marine mammals, with certain exceptions. sections 101(a)(5)(A) and (D) of the MMPA (16 U.S.C. 1361 et seq. ) direct the Secretary of Commerce (as delegated to NMFS) to allow, upon request, the incidental, but not intentional, taking of small numbers of marine mammals by U.S. citizens who engage in a specified activity (other than commercial fishing) within a specified geographical region if certain findings are made and either regulations are proposed or, if the taking is limited to harassment, a notice of a proposed incidental take authorization (ITA) is provided to the public for review.
Authorization for incidental takings shall be granted if NMFS finds that the taking will have a negligible impact on the species or stock(s) and will not have an unmitigable adverse impact on the availability of the species or stock(s) for taking for subsistence uses, where relevant. Further, NMFS must prescribe the permissible methods of taking and other “means of effecting the least practicable adverse impact” on the affected species or stocks and their habitat, paying particular attention to rookeries, mating grounds, and areas of similar significance, and on the availability of the species or stocks for taking for certain subsistence uses (referred to in shorthand as “mitigation”); and requirements pertaining to the mitigation, monitoring and reporting of the takings are set forth (section 101(5)(A)(i)(II)(aa)).

Summary of Request
On October 18, 2023, NMFS received a request (Application) from the USACE for authorization to take marine mammals incidental to construction activities associated with the LCR DMMP in Oregon and Washington. After the applicant responded to our questions and redrafted the Application, we determined the Application was adequate and complete on April 25, 2024. On May 14, 2024, we published a notice of receipt of the USACE Application in the Federal Register , requesting comments and information related to the request for 30 days (89 FR 41941). We received no public comments during the public comment period.
On November 13, 2024, NMFS published a notice of proposed rulemaking and request for public comments in the Federal Register (89 FR 89543). All comments were considered in development of this final rule (see Comments and Responses). The USACE's request is for the take of harbor seal ( Phoca vitulina ), Steller sea lion ( Eumetopias jubatus ), and California sea lion ( Zalophus californianus ) by Level B harassment and, for harbor seal only, by Level A harassment. The regulations are valid for 5 years (2027-2032).

Description of the Activity
The USACE has developed a draft DMMP to support continued operation and maintenance of the LCR Federal Navigation Channel (FNC) for the next 20 years. The full draft DMMP includes planned dredging and placement operations between river miles (RM) 3 (4.8 kilometers (km)) and 105.5 (169.8 km). However, the scope of this request for a LOA is limited to potential pile driving that would be associated with any new steel and timber piles installed between RM 23 and 36. Work on additional reaches of the LCR will likely occur in subsequent years. The USACE is anticipating up to 141 days of in-water work between November 2027 and February 2032 and is planning to install 1,039 steel piles and 1,029 timber piles by vibratory and impact driving over the 5-year LOA period for a total of 2,068 piles. No concurrent driving of piles is planned.
A detailed description of the planned construction project is provided in the Federal Register notice for the proposed rule (89 FR 89543). Since that time, no changes have been made to the planned activities. Therefore, a detailed description is not provided here.

Comments and Responses
NMFS' notice of proposed rulemaking was published in the Federal Register on November 13, 2024 (89 FR 89543). That proposed rule described, in detail, the USACE's activities, the marine mammal species that may be affected by the activities, and the anticipated effects on marine mammals. In that proposed rule, we requested public input on the request for authorization described therein, our analyses, the proposed authorization, and any other aspect of the notice of proposed rulemaking, and requested that interested persons submit relevant information, suggestions, and comments.
During the 30-day public comment period, NMFS received four substantive comment submissions from members of the public and from the Center for Regulatory Freedom. NMFS' responses to the comments are provided below, and all comments are available online at: https://www.regulations.gov/document/NOAA-NMFS-2024-0123-0001/comment.
Comment 1: One commenter inquired if plans for the dredging project extend beyond the allotted 5-year LOA effective period of 2027-2032. The commenter also asked if the USACE would reapply for authorized take if work were undertaken beyond the end of the effective date of this LOA (February 29, 2032).
Response: The USACE has stated that it plans additional construction activities at other locations during the 2033/2034 and 2034/2035 work windows along the LCR that were not analyzed and are not covered under this rulemaking and LOA. The USACE would need to submit an application for an ITA in the form of an IHA or LOA for any work that could result in incidental take of marine mammals occurring after the end of the LOA's effective date (February 29, 2032). Additionally, any activities planned to occur under this LOA that were not completed would need to be included in subsequent incidental take authorizations requested by the USACE.
Comment 2: A commenter asked how NMFS would respond in a situation in which take of marine mammals is higher than predicted.
Response: In the event that the USACE exceeds the authorized or predicted take levels, any further take would be unauthorized and therefore, prohibited under the MMPA. The USACE would require authorization for additional activities that could result in incidental take. Providing such authorization would require NMFS to reanalyze its small numbers and negligible impact determinations. Under certain conditions, including monitoring data showing rates of take in excess of expectations, the LOA could potentially be modified to increase the number of authorized takes and/or adjust mitigation measures. See Adaptive Management section and 50 CFR 217.77 (addressing LOA modification requests).
Comment 3: A member of the public asked if alternate locations are available to install the specified infrastructure.
Response: The LCR DMMP is a coordinated, long-term plan for managing dredged material generated by the continued operations and maintenance (O&M) of the LCR Federal Navigation Channel (FNC) for a minimum of 20 years to continue to provide a 43-foot-deep and 600-foot-wide channel. Existing pile dike structures reduce dredging needs and confine dredged material. The purpose of repairs or replacement is to restore full function of a pile dike system in the context of existing (present day) channel configuration, hydrologic, and environmental river conditions. Functional pile dikes are critical for continued navigation channel maintenance and have been placed in specific locations to maximize operational conditions. Specifically, these defined locations are the best solution for providing sufficient dredged material placement capacity while also providing environmental, economic, and social benefits by sustaining the Columbia River's sediment budget and morphology, developing fish and wildlife habitat, and providing opportunities for recreation and commercial uses to include fishing, nourishment, aesthetics, and bird watching. Removal and relocation of these pile dikes would likely negatively impact one or more of the described benefits.
Comment 4: A member of the public asked to see alternate plans in the case of undue harm to local wildlife populations at the proposed pile-driving sites.
Response: NMFS did not develop alternatives as part of the analysis of the Application because the agency determined the action fell within Categorical Exclusion B4 of the Companion Manual for NAO 216-6A (available at https://www.noaa.gov/sites/default/files/2021-10/NOAA-NAO-216-6A-Companion-Manual-03012018%20%281%29.pdf ), and therefore a National Environmental Policy Act (NEPA) analysis (which could include an alternatives analysis) is unnecessary. Any undue harm would likely be exceedance of authorized take numbers or take in excess of expected levels. In such situations, the LOA could be modified to accommodate the predicted increase in take and/or mitigation measures could be revised if such modifications would have a reasonable likelihood of reducing adverse effects to marine mammals and if the measures are practicable. See Adaptive Management section and 50 CFR 217.77(c) (addressing LOA modification requests).
Comment 5: One commenter inquired about the potential impacts to affected animals when they are physically moved to areas away from the project location.
Response: The USACE did not request and NMFS has not authorized the intentional relocation of marine mammals away from the project area. The USACE requested and NMFS has authorized the take of marine mammals incidental to DMMP project activities. Take would occur by harassment only (defined in Estimated Take of Marine Mammals section), incidental to impact and vibratory pile driving. Relocation of marine mammals would constitute an intentional act, i.e., not an incidental taking, and, therefore, cannot be addressed through sections 101(a)(5)(A) or (D) of the MMPA. Note that this action is not related to the Pinniped Removal Program at Bonneville Dam ( https://www.fisheries.noaa.gov/west-coast/marine-mammal-protection/marine-mammal-protection-act-section-120-pinniped-removal ).
Comment 6: A member of the public who supported the issuance of the LOA also strongly encouraged NMFS to implement comprehensive mitigation measures designed to protect vulnerable species. Recommended measures included abiding by season restrictions, utilizing real-time monitoring systems, employing advanced noise reduction techniques, and applying adaptive management strategies. They also stressed the importance of transparency in monitoring and reporting efforts.
Response: All of the mitigation measures described by the commenter have been included in the regulations and the LOA. See the Mitigation section for information on noise reduction techniques ( i.e., bubble curtains, soft-start). Information on seasonal restrictions, real-time monitoring ( i.e., use of protected species observers (PSOs)) and reporting may be found in the Monitoring and Reporting section. Transparency is achieved by requiring monitoring during all activities that could result in the harassment of marine mammals and posting monitoring reports to our website for the public to view after they have been submitted and then reviewed and approved by NMFS. ( https://www.fisheries.noaa.gov/permit/incidental-take-authorizations-under-marine-mammal-protection-act ). Adaptive management options are also included in the regulations with additional information located in the Adaptive Management section.
Comment 7: The Center for Regulatory Freedom (CRF) indicated support for the authorization of incidental take associated with the dredging activities at issue. However, CRF recommended withdrawal of the proposed rule and a “fundamental reform of incidental takings under the MMPA and ESA,” stating that transparency, consistency, and fairness in decision-making should be prioritized (and suggesting that these are currently lacking). The CRF wrote that Federal agencies tasked with enforcing the MMPA and ESA must establish clear, science-based standards for evaluating environmental impacts.
Response: NMFS appreciates the support for the authorization of incidental take of marine mammals associated with the project. The comment does not provide analysis or information specific to the impact of this project on marine mammals. The commenters' concerns about the overall framework of the MMPA and ESA incidental take regulations are outside the scope of this individual authorization and rulemaking.

Changes From the Proposed Rule to Final Rule
On May 3, 2024, NMFS published (89 FR 36762) and solicited public comment on its draft updated Technical Guidance ( https://www.fisheries.noaa.gov/national/marine-mammal-protection/marine-mammal-acoustic-technical-guidance ), which includes updated thresholds and weighting functions to inform auditory injury estimates, and is intended to replace the 2018 Technical Guidance (NMFS 2018). The 2024 Technical Guidance was finalized on October 24, 2024 (89 FR 84872). The Federal Register notice for the proposed rule (89 FR 89543) for this regulation included a basic comparative analysis of the 2018 and 2024 Technical Guidance document since at that time it was unclear when the 2024 Technical Guidance would be finalized. The revised guidance results in changes to the Level A harassment and shutdown zones (see Estimated Take and Mitigation), which are discussed below. The updated analysis based on the 2024 Technical Guidance did not change the take numbers authorized through this rule.

Description of Marine Mammals in the Area of Specified Activities
Sections 3 and 4 of the Application summarize available information regarding status and trends, distribution and habitat preferences, and behavior and life history of the potentially affected species. NMFS fully considered all of this information, and we refer the reader to these descriptions, instead of reprinting the information. Additional information regarding population trends and threats may be found in NMFS' Stock Assessment Reports (SARs) (see https://www.fisheries.noaa.gov/national/marine-mammal-protection/marine-mammal-stock-assessments ) and more general information about these species ( e.g., physical and behavioral descriptions) may be found on NMFS' website at: https://www.fisheries.noaa.gov/find-species.
Table 1 lists all species or stocks for which take is expected and authorized for this activity and summarizes information related to the population or stock, including regulatory status under the MMPA and the ESA and potential biological removal (PBR), where known. PBR is defined by the MMPA as the maximum number of animals, not including natural mortalities, that may be removed from a marine mammal stock while allowing that stock to reach or maintain its optimum sustainable population (as described in NMFS' SARs). While no serious injury or mortality is anticipated or authorized here, PBR and annual serious injury and mortality from anthropogenic sources are included here as gross indicators of the status of the species or stocks and other threats.
Marine mammal abundance estimates presented in this document represent the total number of individuals that make up a given stock or the total number estimated within a particular study or survey area. NMFS' stock abundance estimates for most species represent the total estimate of individuals within the geographic area, if known, that comprises that stock. For some species, this geographic area may extend beyond U.S. waters. All managed stocks in this region are assessed in NMFS' U.S. Pacific and Alaska SARs. All values presented in table 1 are the most recent available at the time of publication (including from the 2023 SARs) and are available online at: https://www.fisheries.noaa.gov/national/marine-mammal-protection/marine-mammal-stock-assessments.
Table 1—Marine Mammal Species ^1 Likely Impacted by the Specified Activities
Common name | Scientific name | Stock | ESA/ MMPA status; strategic (Y/N) ^2 | Stock abundance (CV, N min , most recent abundance survey) ^3 | PBR | Annual M/SI ^4
Order Carnivora—Pinnipedia
Family Otariidae (eared seals and sea lions):
California Sea Lion | Zalophus californianus | U.S. | -, -, N | 257,606 (N/A, 233,515, 2014) | 14,011 | >321
Steller Sea Lion | Eumetopias jubatus | Eastern | -, -, N | 36,308 ^5 (N/A, 36,308, 2022) | 2,178 | 93.2
Family Phocidae (earless seals):
Harbor Seal | Phoca vitulina | OR/WA Coastal | -, -, N | 24,731 ^6 (1999) | UND | 10.6
^1 Information on the classification of marine mammal species can be found on the web page for The Society for Marine Mammalogy's Committee on Taxonomy at: https://marinemammalscience.org/science-and-publications/list-marine-mammal-species-subspecies.
^2 ESA status: Endangered (E), Threatened (T)/MMPA status: Depleted (D). A dash (-) indicates that the species is not listed under the ESA or designated as depleted under the MMPA. Under the MMPA, a strategic stock is one for which the level of direct human-caused mortality exceeds PBR or which is determined to be declining and likely to be listed under the ESA within the foreseeable future. Any species or stock listed under the ESA is automatically designated under the MMPA as depleted and as a strategic stock.
^3 NMFS marine mammal SARs online at: https://www.fisheries.noaa.gov/national/marine-mammal-protection/marine-mammal-stock-assessment-reports-region. CV is coefficient of variation; N min is the minimum estimate of stock abundance. In some cases, CV is not applicable.
^4 These values, found in NMFS's SARs, represent annual levels of human-caused mortality plus serious injury from all sources combined ( e.g., commercial fisheries, ship strike). Annual M/SI often cannot be determined precisely and is in some cases presented as a minimum value or range. A CV associated with estimated mortality due to commercial fisheries is presented in some cases.
^5 Nest is best estimate of counts, which have not been corrected for animals at sea during abundance surveys. Estimates provided are for the U.S. only.
^6 There is no current estimate of abundance available for this stock. Value presented is the most recent available and based on 1999 data.
A detailed description of the species likely to be affected by the USACE's construction project, including brief introductions to the species and relevant stocks as well as available information regarding population trends and threats, and information regarding local occurrence, were provided in the Federal Register notice for the proposed rule (89 FR 89543, November 13, 2024); since that time, we are not aware of any changes in the status of these species and stocks; therefore, detailed descriptions are not provided here. Please refer to that Federal Register notice for these descriptions. Please also refer to NMFS' website ( https://www.fisheries.noaa.gov/find-species ) for generalized species information.

Marine Mammal Hearing
Hearing is the most important sensory modality for marine mammals underwater, and exposure to anthropogenic sound can have deleterious effects. To appropriately assess the potential effects of exposure to sound, it is necessary to understand the frequency ranges marine mammals are able to hear. Not all marine mammal species have equal hearing capabilities ( e.g., Richardson et al., 1995; Wartzok and Ketten, 1999; Au and Hastings, 2008). To reflect this, Southall et al. (2007, 2019) recommended that marine mammals be divided into hearing groups based on directly measured (behavioral or auditory evoked potential techniques) or estimated hearing ranges (behavioral response data, anatomical modeling, etc. ). Subsequently, NMFS (2018, 2024) described generalized hearing ranges for these marine mammal hearing groups. Generalized hearing ranges were chosen based on the approximately 65 decibel (dB) threshold from the normalized composite audiograms, with the exception for lower limits for low-frequency cetaceans where the lower bound was deemed to be biologically implausible and the lower bound from Southall et al. (2007) retained.
As noted in Changes From the Proposed Rule to Final Rule, we previously considered both the 2018 and 2024 Technical Guidance in our effects and estimated take analysis. However for the final rule we are only including information relevant to the 2024 Technical Guidance.
Marine mammal hearing groups and their associated hearing ranges from NMFS (2024) are provided in table 2. In the Updated Technical Guidance, mid-frequency cetaceans have been re-classified as high-frequency cetaceans, and high-frequency cetaceans have been updated to very-high-frequency (VHF) cetaceans. Additionally, the Updated Technical Guidance includes in-air data for phocid (PA) and otariid (OA) pinnipeds.
Table 2—Marine Mammal Hearing Groups
[NMFS, 2024]
Hearing group | Generalized hearing range *
Low-frequency (LF) cetaceans (baleen whales) | 7 Hz to 36 kHz.
High-frequency (HF) cetaceans (dolphins, toothed whales, beaked whales, bottlenose whales) | 150 Hz to 160 kHz.
Very High-frequency (VHF) cetaceans (true porpoises, Kogia, river dolphins, Cephalorhynchid, Lagenorhynchus cruciger & L. australis ) | 200 Hz to 165 kHz.
Phocid pinnipeds (PW) (underwater) (true seals) | 40 Hz to 90 kHz.
Otariid pinnipeds (OW) (underwater) (sea lions and fur seals) | 60 Hz to 68 kHz.
* Represents the generalized hearing range for the entire group as a composite ( i.e., all species within the group), where individual species' hearing ranges may not be as broad. Generalized hearing range chosen based on ~65 dB threshold from composite audiogram, previous analysis in NMFS 2018, and/or data from Southall et al. 2007; Southall. 2019. Additionally, animals are able to detect very loud sounds above and below that “generalized” hearing range.
For more detail concerning these groups and associated frequency ranges, please see NMFS (2024) for a review of available information.

Effects of Specified Activities on Marine Mammals and Their Habitat
The effects of underwater noise from the USACE's construction activities have the potential to result in behavioral harassment of marine mammals in the vicinity of the project area. The proposed rule (89 FR 89543) included a discussion of the effects of anthropogenic noise on marine mammals and the potential effects of underwater noise from the USACE's construction on marine mammals and their habitat. That information and analysis is referenced in this final rule and is not repeated here.

Estimated Take of Marine Mammals
This section provides an estimate of the number of incidental takes that may be authorized, which will inform both NMFS' consideration of whether the activities will take “small numbers” of marine mammals and the negligible impact determinations.
Harassment is the only type of take expected to result from these activities. Except with respect to certain activities not pertinent here, section 3(18) of the MMPA defines “harassment” as any act of pursuit, torment, or annoyance, which (i) has the potential to injure a marine mammal or marine mammal stock in the wild (Level A harassment); or (ii) has the potential to disturb a marine mammal or marine mammal stock in the wild by causing disruption of behavioral patterns, including, but not limited to, migration, breathing, nursing, breeding, feeding, or sheltering (Level B harassment) (16 U.S.C. 1362(18)(A)(i)-(ii)).
For acoustic impacts, generally speaking, we estimate take by considering (1) acoustic thresholds above which NMFS believes the best available science indicates marine mammals will be behaviorally harassed or incur some degree of permanent hearing impairment, (2) the area or volume of water that will be ensonified above these levels in a day, (3) the density or occurrence of marine mammals within these ensonified areas, and (4) the number of days of activities. We note that while these factors can contribute to a basic calculation to provide an initial prediction of potential takes, additional information that can qualitatively inform take estimates is also sometimes available ( e.g., previous monitoring results or average group size). Below, we describe the factors considered here in more detail and present the take estimates.
Authorized takes would primarily be by Level B harassment, as use of the acoustic source ( i.e., pile driving) has the potential to result in disruption of behavioral patterns for individual marine mammals. There is also some potential for auditory injury (Level A harassment) to result, primarily for phocids because predicted auditory injury zones are larger than for otariids. Auditory injury is unlikely to occur for otariids. The required mitigation and monitoring measures are expected to minimize the severity of the taking to the extent practicable.
As described previously, no serious injury or mortality is anticipated or authorized for this activity. We describe below how the authorized take numbers have been estimated.

Acoustic Thresholds
NMFS uses acoustic thresholds to identify the received level of underwater sound above which exposed marine mammals would be reasonably expected to be behaviorally harassed (equated to Level B harassment) or to incur permanent threshold shift (PTS), defined as “a permanent, irreversible increase in the threshold of audibility at a specified frequency or portion of an individual's hearing range above a previously established reference levels” (89 FR at 89550) ( i.e. hearing loss) of some degree (equated to Level A harassment).
Level B Harassment —Though significantly driven by received level (the level of sound at a specified distance of interest ( i.e., at the animal or receiver)), the onset of behavioral disturbance from anthropogenic noise exposure is also informed to varying degrees by other factors related to the source or exposure context ( e.g., frequency, predictability, duty cycle, duration of the exposure, signal-to-noise ratio, distance to the source), the environment ( e.g., bathymetry, other noises in the area, predators in the area), and the receiving animals (hearing, motivation, experience, demography, life stage, depth) and can be difficult to predict ( e.g., Southall et al., 2007, 2021; Ellison et al., 2012). Based on what the available science indicates and the practical need to use a threshold based on a metric that is both predictable and measurable for most activities, NMFS typically uses a generalized acoustic threshold based on received level to estimate the onset of behavioral harassment. NMFS generally predicts that marine mammals are likely to be behaviorally harassed in a manner considered to be Level B harassment when exposed to underwater anthropogenic noise above root-mean-squared pressure received levels (RMS SPL) of 120 dB (referenced to 1 micropascal (re 1 μPa)) for continuous sources of noise ( e.g., vibratory pile driving, drilling) and above RMS SPL 160 dB re 1 μPa for non-explosive impulsive ( e.g., seismic airguns) or intermittent ( e.g., scientific sonar) sources. Level B harassment could also take place due to temporary threshold shift (TTS), “a temporary, reversible increase in the threshold of audibility at a specified frequency or portion of an individual's hearing range above a previously established reference level” (89 FR at 89552) ( i.e., temporary hearing loss). Generally speaking, Level B harassment take estimates based on behavioral harassment thresholds are expected to include any likely takes by TTS as, in most cases, takes from TTS are likely at shorter distances from the source than those at which behavioral harassment is likely. TTS of a sufficient degree can manifest as behavioral harassment, as reduced hearing sensitivity and the potential reduced opportunities to detect important signals ( e.g., conspecific communication, predators, prey) may result in changes in behavior patterns that would not otherwise occur.
The USACE's planned activity includes the use of continuous (vibratory pile driving) and impulsive (impact pile driving) sources, and therefore NMFS will use the RMS SPL thresholds of 120 and 160 dB re 1 μPa to determine whether marine mammals are experiencing Level B harassment.
Level A Harassment —NMFS' 2024 Updated Technical Guidance (NMFS, 2024) identifies dual criteria to assess auditory injury (Level A harassment) to five different marine mammal groups (based on hearing sensitivity) as a result of exposure to noise from two different types of sources (impulsive or non-impulsive). These thresholds are provided in table 3 below. The references, analysis, and methodology used in the development of the thresholds are described in NMFS' 2018 Technical Guidance and NMFS' 2024 Updated Technical Guidance, both of which may be accessed at: https://www.fisheries.noaa.gov/national/marine-mammal-protection/marine-mammal-acoustic-technical-guidance.
The USACE's planned activity includes the use of impulsive (impact pile driving) and non-impulsive (vibratory driving) sources.
Table 3—NMFS' 2024 Thresholds Identifying the Onset of Auditory Injury
[AUD INJ]
Hearing group | AUD INJ acoustic thresholds * (received level) | Impulsive | Non-impulsive
UNDERWATER:
Low-Frequency (LF) Cetaceans | Cell 1: L p, 0-pk,flat : 222 dB; L E, p, LF,24h : 183 dB | Cell 2: L E, p, LF,24h : 197 dB.
High-Frequency (HF) Cetaceans | Cell 3: L p, 0-pk,flat : 230 dB; L E, p, HF,24h : 193 dB | Cell 4: L E, p, HF,24h : 201 dB.
Very High-Frequency (VHF) Cetaceans | Cell 5: L p, 0-pk,flat : 202 dB; L E, p, VHF,24h : 159 dB | Cell 6: L E, p, VHF,24h : 181 dB.
Phocid Pinnipeds (PW) (Underwater) | Cell 7: L p, 0-pk.flat : 223 dB; L E, p, PW,24h : 183 dB | Cell 8: L E, p, PW,24h : 195 dB.
Otariid Pinnipeds (OW) (Underwater) | Cell 9: L p, 0-pk,flat : 230 dB; L E, p, OW,24h : 185 dB | Cell 10: L E, p, OW,24h : 199 dB.
IN-AIR:
Phocid Pinnipeds (PA) (In-Air) | Cell 11: L p, 0-pk.flat : 162 dB; L E, p, PA,24h : 140 dB | Cell 12: L E, p, PA,24h : 154 dB.
Otariid Pinnipeds (OA) (In-Air) | Cell 13: L p, 0-pk,flat : 177 dB; L E, p, OA,24h : 163 dB | Cell 14: L E, p, OA,24h : 177 dB.
* Dual metric acoustic thresholds for impulsive sounds: Use whichever results in the largest isopleth for calculating AUD INJ onset. If a non-impulsive sound has the potential of exceeding the peak sound pressure level thresholds associated with impulsive sounds, these thresholds should also be considered.
Note: Peak sound pressure ( L pk ) has a reference value of 1 µPa, and cumulative sound exposure level ( L E ) has a reference value of 1µPa ^2 s. In this table, thresholds are abbreviated to reflect American National Standards Institute standards (ANSI, 2013). However, peak sound pressure is defined by ANSI as incorporating frequency weighting, which is not the intent for NMFS' 2018 Technical Guidance. Hence, the subscript “flat” is being included to indicate peak sound pressure should be flat weighted or unweighted within the generalized hearing range. The subscript associated with cumulative sound exposure level thresholds indicates the designated marine mammal auditory weighting function (LF, MF, and HF cetaceans, and PW and OW pinnipeds) and that the recommended accumulation period is 24 hours. The cumulative sound exposure level thresholds could be exceeded in a multitude of ways ( i.e., varying exposure levels and durations, duty cycle). When possible, it is valuable for action proponents to indicate the conditions under which these acoustic thresholds will be exceeded.

Ensonified Area
This section describes the operational and environmental parameters of the activity that are used in estimating the area ensonified (or sound field) above the acoustic thresholds, including source levels and transmission loss ( TL ) coefficient.
The sound field in the project area is the existing background noise plus additional construction noise from the planned project. Pile driving generates underwater noise that can potentially result in disturbance to marine mammals in the Project Area. The maximum (underwater) area ensonified is determined by the topography of the LCR, including intersecting land masses that will reduce the overall area of potential impact. Additionally, vessel traffic in the LCR during construction may contribute to elevated background noise levels, which may mask sounds produced by the project.
TL is the decrease in acoustic intensity as an acoustic pressure wave propagates out from a source. TL parameters vary with frequency, temperature, sea conditions, current, source and receiver depth, water depth, water chemistry, and bottom composition and topography. The general formula for underwater TL is:
TL = B × Log 10 ( R 1 / R 2 ),
where
TL = transmission loss in dB;
B = transmission loss coefficient; for practical spreading equals 15;
R 1 = the distance of the modeled SPL from the driven pile; and,
R 2 = the distance from the driven pile of the initial measurement.
This formula neglects loss due to scattering and absorption, which is assumed to be zero here. The degree to which underwater sound propagates away from a sound source is dependent on a variety of factors, most notably the water bathymetry and presence or absence of reflective or absorptive conditions including in-water structures and sediments. Spherical spreading occurs in a perfectly unobstructed (free-field) environment not limited by depth or water surface, resulting in a 6-dB reduction in sound level for each doubling of distance from the source (20 × log 10 [range]). Cylindrical spreading occurs in an environment in which sound propagation is bounded by the water surface and sea bottom, resulting in a reduction of 3 dB in sound level for each doubling of distance from the source (10 × log 10 [range]). A practical spreading value of 15 is often used under conditions, such as the project site, where water increases with depth as the receiver moves away from the shoreline, resulting in an expected propagation environment that would lie between spherical and cylindrical spreading loss conditions. Practical spreading loss is assumed here.
The intensity of pile driving sounds is greatly influenced by factors such as the type of piles, hammers, and the physical environment in which the activity takes place. In order to calculate the distances to the Level A harassment and the Level B harassment sound thresholds for the methods and piles being used in this project, NMFS used acoustic monitoring data from other locations to develop proxy source levels for the various pile types, sizes and methods (table 4). Generally, we choose source levels from similar pile types from locations ( e.g., geology, bathymetry) similar to the project.
Table 4—Proxy Sound Source Levels for Pile Sizes and Driving Methods
Pile type | Sound pressure level (single strike)
24-in Steel Pipe ^1 Vibratory (unattenuated) | | 159 dB RMS
24-in Steel Pipe ^1 ^3 Impact (attenuated) | 198 dB PEAK | 185 dB RMS | 171 dB SEL .
12-in Timber ^2 Vibratory (unattenuated) | | 162 dB RMS
12-in Timber ^2 ^3 Impact (attenuated) | 175 dB PEAK | 165 dB RMS | 155 dB SEL .
^1 Reference levels based on the Sand Island Test Piles project in the Columbia River (Robert Miner Dynamic Testing 2021). While the original study tested various pile tips for driving through existing enrockment, the DMMP will not use pile tips so we referenced sound levels solely for piles excluding tips during vibratory driving. For impact driving, all piles in the Sand Island study included tips so we used the average SPLs across all piles as a conservative estimate.
^2 All timber pile assumptions are based on Caltrans (2020).
^3 We assume bubble curtains will be employed for all piles installed with an impact hammer under this LOA, thus, SPLs in this table reflect reference noise estimates reduced by 5 dB.
The ensonified area associated with Level A harassment is more technically challenging to predict due to the need to account for a duration component. Therefore, NMFS developed an optional User Spreadsheet tool to accompany the Technical Guidance that can be used to relatively simply predict an isopleth distance for use in conjunction with marine mammal density or occurrence to help predict potential takes. We note that because of some of the assumptions included in the methods underlying this optional tool, we anticipate that the resulting isopleth estimates are typically going to be overestimates of some degree, which may result in an overestimate of potential take by Level A harassment. However, the optional User Spreadsheet tool offers the best way to estimate isopleth distances when more sophisticated modeling methods are not available or practical. For stationary sources such as pile driving, the optional User Spreadsheet tool predicts the distance at which, if a marine mammal remained at that distance for the duration of the activity, it would be expected to incur PTS. Inputs used in the optional User Spreadsheet tool, and the resulting estimated isopleths, are reported in table 5 below. The calculated Level A and Level B harassment isopleths are shown in table 6.
Table 5—NMFS User Spreadsheet Inputs
Pile size and type | Spreadsheet tab used | Weighting factor adjustment (kHz) | Number of piles per day | Duration to drive a single pile (min) | Number of strikes per pile
Vibratory pile driving and removal
24-in steel pile (Vibratory) | A.1) Vibratory pile driving | 2.5 | 20 | 25 | NA
12-in Timber (Vibratory) | A.1) Vibratory pile driving | 2.5 | 20 | 25 | NA
Impact pile driving
24-in steel pile (Impact attenuated) | E.1) Impact pile driving | 2 | 20 | NA | 45
12-in Timber (Impact attenuated) | E.1) Impact pile driving | 2 | 20 | NA | 45
Table 6—Calculated Distance of Level A (Based on NMFS' 2024 Updated Technical Guidance) and Level B Harassment by Pile Type and Pile Driving Method
Pile size and type | Level A harassment (m) | Phocid | Otariid | Level B harassment (m)
Vibratory pile driving
24-in steel pile | 35.9 | 12.1 | 3,981.1
| 12-in timber pile | 56.9 | 19.1 | 6,309.6
Impact pile driving
24-in steel pile | 130.6 | 48.7 | 464.2
12-in timber pile | 11.2 | 4.2 | 21.5

Marine Mammal Occurrence and Take Estimation
In this section we provide information about the occurrence of marine mammals, including density and/or other relevant information which will inform the take calculations and describe how the information provided is synthesized to produce a quantitative estimate of the take that is reasonably likely to occur and may be authorized. The USACE referenced data provided by the Oregon Department of Fish and Wildlife (ODFW) and the Washington Department of Fish and Wildlife (WDFW) to support assumptions regarding marine mammal occurrence in the project area. The ODFW conducts periodic counts of pinnipeds at haul out sites along the Oregon coast and in the LCR. The WDFW has collected recent anecdotal evidence of pinniped abundance at haul out sites in the LCR near the confluence of the Cowlitz River at RM 67.5 (108.6 km). While the confluence of the two rivers is located approximately 31.5 river miles (50.7 km) upstream from the project area, it is the closest site that features data on pinniped activity. The USACE used the proximal count estimates from ODFW and WDFW to estimate the number of harbor seals, Steller sea lions, and California sea lions that could transit or occupy the project area during planned pile driving in winter ( i.e., November through February). For sea lions, the USACE estimated the maximum number of animals likely to be encountered in a single day based on the maximum number of animals detected at haul out sites within 5 mi. (3.1 km) of planned pile driving, as well as the closest haul out sites upstream or downstream. For harbor seals, the USACE estimated the harbor seal density using the approximate span of river where they have been observed at haul out sites.

Harbor Seal
The most recent harbor seal aerial surveys were conducted by ODFW during the 2021 summer pupping season. The average, maximum daily count of harbor seals counted across all haulout sites in the project vicinity in May and June was 837 (pups and non-pups combined) (USACE, 2024). After applying the Huber et al. (2001) correction factor of 1.53, used to account for likely imperfect detection during surveys, the adjusted number of harbor seals that may have been present during the 2021 surveys was 1,281 individuals. However, that estimate is not necessarily representative of the number of harbor seals that may be present in winter.
Jeffries et al. (1984) synthesized survey data collected by the state of Washington to document pinniped abundance and distribution in the LCR between 1980 and 1983. Table 7 summarizes the harbor seal count by month detected over that roughly 3-year study period (Jeffries et al., 1984). The USACE used this data to calculate the average, maximum total count observed across all haulout sites in the project vicinity to estimate the proportion of animals present from November through February relative to counts observed from May to June. The average harbor seal count observed between November and February was approximately 618 animals, whereas the average count for May and June was roughly 464. The count of harbor seals in winter was 1.33 times the number counted in May and June. To account for this seasonality, the most recent estimate of 1,281 harbor seals in the project vicinity during the pupping season, based on ODFW counts, could equate to a maximum of 1,706 harbor seals in the project vicinity each day in winter. While the USACE and NMFS acknowledge that the seasonal correction factor is based on data that is over 40 years old, all recent surveys have focused solely on the summer pupping season and there is no winter data corresponding to those counts. Therefore, the USACE, with NMFS' concurrence, relied on available data from a historic study that included counts for multiple seasons in the same year.
The USACE assumed the maximum winter abundance of 1,706 individuals and an even distribution of animals throughout the span of river between the river mouth and the upstream end of Tenasillahe Island shown in figure 6-21 in the Application. The hatched area in figure 6-21 represents the project area and amounts to roughly 377 square kilometers (km ^2 ), yielding an approximate daily harbor seal density of five individuals per km ^2 in the project area.
Table 7—Maximum Monthly Counts of Harbor Seals Detected During Low-Tide Aerial Surveys at Haulout Locations in the Lower Columbia River Estuary Between 1980 and 1983
[Adapted from Jeffries et al., 1984]
Month | South Jetty | Baker Bay | Desdemona Sands | Taylor Sands | Grays Bay | Miller Sands | Green Island | N of Woody Island | Total
January | 0 | 0 | 566 | 444 | 1 | 381 | 0 | 72 | 1,464
February | 0 | NS | NS | NS | NS | * 200 | NS | 55 | 255
March | 1 | 0 | * 650 | 548 | 0 | 82 | 0 | 3 | 1,284
April | 0 | * 20 | 884 | 260 | * 20 | 137 | 0 | 18 | 1,339
May | 0 | 1 | 568 | 4 | 4 | 0 | 16 | 0 | 593
June | 1 | 0 | 273 | 22 | 11 | 1 | * 26 | * 0 | 334
| July | 0 | 0 | 525 | 21 | 10 | 0 | 38 | 0 | 594
August | 3 | 7 | 378 | 0 | 0 | 32 | 35 | 0 | 455
September | 4 | 11 | 563 | 7 | 12 | 0 | 26 | 0 | 623
October | 0 | * 25 | 223 | 59 | 0 | 6 | 0 | 0 | 313
November | NS | NS | * 230 | NS | NS | NS | NS | NS | 230
December | 0 | 0 | 301 | 174 | 0 | 46 | 0 | 0 | 521
NS = Not Surveyed.
* Count based on visual estimate from airplane, boat, or jetty.
For harbor seals only, take by Level A and Level B harassment was calculated based on the following equations, which were performed for Level A and Level B harassment and for steel and timber piles:
Harassment = Harbor seal density * ensonified area * pile driving workdays
The estimated isopleth areas associated with the longest pile dike at each site are presented in table 8. These inputs were used in the equation above to estimate the number of harbor seals possible within those isopleths each day (table 9) and then calculate the overall level of take based on the number of workdays projected in each year (table 10). The number of takes requested by Level A and Level B harassment by the USACE for Year 1 through Year 5 are shown in table 10. The calculated take by Level A harassment is likely an overestimate because the likelihood of a harbor seal coming within a specified Level A harassment isopleth of the pile and remaining long enough to experience PTS during the brief period of potential impact driving that could be needed to reach the last ~5 ft (1.5 m) of embedment depth is fairly low. In addition, the USACE utilized the Level A harassment isopleth area of the longest pile dike at each site, when in actuality, some sites have shorter structures, and a pile dike is composed of multiple individual piles with much smaller noise isopleths. NMFS concurs with this assessment and will authorize harbor seal take according to the totals contained in table 10.
Table 8—Pile Dike Lengths ( m ) and Corresponding Level A and Level B Harassment Areas
[
km
2
]
Site | Pile dike length (m) | Phocids level A (km ^2 ) 24-in steel impact | All marine mammals Level B (km 2 ) 24-in steel impact | All marine mammals Level B (km 2 ) 24-in steel vibratory | All marine mammals Level B (km 2 ) 12-in timber vibratory
O-23.5-BN-ADD1 | 22.40 | 0.213 | 0.74 | 37.29 | 81.45
O-23.5-BN-ADD2 | 25.00 | 0.180 | 0.58 | 18.06 | 30.79
O-27.3-BN | 27.86 | 0.162 | 0.68 | 13.52 | 22.97
O-31.4-BN | 31.46 | 0.293 | 1.05 | 17.97 | 26.33
O-35.6-IW-D | 35.41 | 0.135 | 0.63 | 10.70 | 16.51
Table 9—Estimated Harbor Seals in Level A and Level B Harassment Zones per Day
Site | Installation timeframe | HS * in level A isopleth area 24-in steel impact | HS in Level B isopleth area 24-in steel impact | HS in Level B isopleth area 24-in steel vibratory | HS in Level B isopleth area 12-in timber vibratory
O-23.5-BN-ADD1 | LOA YR-3 | 2 | 4 | 187 | 408
O-23.5-BN-ADD2 | LOA YR-1 | 1 | 3 | 91 | 154
O-27.3-BN | LOA YR-4 | 1 | 4 | 68 | 115
O-31.4-BN | LOA YR-5 | 2 | 6 | 90 | 132
O-35.6-IW-D | LOA YR-2 | 1 | 4 | 54 | 83
Table 10—Calculated Level A and Level B Harassment Take for Harbor Seals During Pile Driving Activities Each Year
| Site | Steel pile driving workdays | Timber pile driving workdays | Level A (steel piles) | Level B (steel piles) | Level B (timber piles)
YR-1 | O-23.5-BN-ADD2 | 13 | 12 | 26 | 2,405 | 4,896
YR-2 | O-35.6-IW-D | 1 | 0 | 1 | 90 | 0
YR-3 | O-23.5-BN-ADD1 | 17 | 17 | 17 | 1,139 | 1,955
| YR-4 | O-27.3-BN | 15 | 15 | 30 | 1,320 | 1,980
YR-5 | O-31.4-BN | 26 | 25 | 26 | 1,378 | 2,075

California and Steller Sea Lions
Take estimates for California and Steller sea lions were based on assumed daily abundances in the project area rather than the estimated densities. The ODFW counted sea lions during recent aerial surveys of three key haulout locations in the LCR. All sea lions detected in winter are non-pup males and average counts of both California and Steller sea lions observed during surveys between 2019 and 2022 are shown in table 11. The haulout at East Mooring Basin (EMB) is just south of the project area and likely downstream of pile driving harassment isopleths. The USACE used the average counts observed at EMB (RM 15 (25 km) from there) as a proxy for sea lions that may be present during pile driving and used the average across all winter months as a proxy for the number of sea lions in the project area since that haulout is closer to the project area (RM 23 (37 km) to RM 36 (57.9 km)) compared to the Rainer (RM 67 (107.8 km)) and Coffin Rock (RM 72 115.9 km)) locations. Based on counts of sea lions at the EMB site (table 11), the USACE estimated 182 California sea lions and 3 Steller sea lions by Level B harassment per day in the project vicinity. Level A harassment is not likely since the Level A harassment zones for otariids are smaller than the shutdown zone calculated (15-20 m) for all pile driving scenarios as shown in table 9, and no such take is authorized.
Table 11—Average Counts of California and Steller Sea Lions Detected at Haulout Locations Depicted in Figure 4-2 During ODFW Winter Aerial Surveys, 2019-2022
[USACE, 2024]
Haulout site | Month | Average of CSL | Average of SSL
East Mooring Basin (EMB) | November | 128 | 0
| December | 234 | 3
| January | 166 | 4
| February | 197 | 5
Take estimates for California and Steller sea lions were calculated based on the equation below and number of workdays shown in table 12:
Level B exposure = N animals/day * total driving days
There could be 25 total days of noise exposure from pile driving during year 1 (YR-1); 34 days in YR-3; 30 days in YR-4, and up to 51 days in YR-5.
Table 12—Authorized Take by Level B Harassment for California and Steller Sea Lions Likely To Be in the Project Vicinity
| Total pile driving workdays | Level B harassment CSL | Level B harassment SSL
YR-1 | 25 | 4,550 | 75
YR-2 | 1 | 182 | 3
YR-3 | 34 | 6,188 | 102
YR-4 | 30 | 5,460 | 90
YR-5 | 51 | 9,282 | 153
The annual and total number of takes of marine mammal species requested by the USACE and authorized for take by NMFS are shown in table 13.
Table 13—Authorized Takes by Level A Harassment and Level B Harassment Annually Over 5 Years
Species | Stock | Yr 1 | Level A | Level B | Yr 2 | Level A | Level B | Year 3 | Level A | Level B | Yr 4 | Level A | Level B | Yr 5 | Level A | Level B | 5-Yr total | Level A | Level B
Harbor Seal | OR/WA Coastal | 26 | 7,301 | 1 | 90 | 17 | 3,094 | 30 | 3,300 | 26 | 3,453 | 87 | 17,238
California sea lion | U.S. | | 4,550 | | 182 | | 6,188 | | 5,460 | | 9,282 | | 25,662
Steller sea lion | Eastern | | 75 | | 3 | | 102 | | 90 | | 153 | | 423
To inform both the negligible impact analysis and the small numbers determination, NMFS assesses the maximum number of takes of marine mammals that could occur within any given year during the effective LOA period. In this calculation, the maximum estimated number of Level A harassment takes in any one year is summed with the maximum estimated number of Level B harassment takes in any one year for each species to yield the highest number of estimated take that could occur in any year (table 14). Table 14 also depicts the number of takes that will be authorized by NMFS relative to the abundance of each stock.
Table 14—Maximum Number of Authorized Takes (by Level A Harassment and Level B Harassment) That Could Occur in Any One Year of the Project Relative to Stock Population Size
Species | NMFS stock abundance | Maximum Level A harassment | Maximum Level B harassment | Maximum annual take ^1 | Total percent stock taken based on maximum annual take
Harbor seal | ^2 24,732 | 30 | 7,301 | 7,331 | 29.6
California sea lion | 257,606 | | 9,282 | 9,282 | 3.6
Steller sea lion | 36,308 | | 153 | 153 | <0.01
^1 Calculations of the maximum annual take are based on the maximum requested Level A harassment take in any one year + the total requested Level B harassment take in any one year.
^2 The Oregon/Washington Coastal Stock was most recently estimated at 24,732 harbor seals in 1999 and more recent abundance data is not available (Carretta et al., 2022).

Mitigation
Under section 101(a)(5)(D)(ii) of the MMPA, NMFS must set forth (1) “the permissible methods of taking pursuant to the activity” and (2) “other means of effecting the least practicable impact on the species or stock and its habitat, paying particular attention to rookeries, mating grounds, and areas of similar significance.” NMFS regulations require applicants for incidental take authorizations to include information about “the availability and feasibility (economic and technological) of equipment, methods, and manner of conducting [the] activity or other means of effecting the least practicable adverse impact upon the affected species or stocks [and] their habitat.” (50 CFR 216.104(a)(11)).
In evaluating how mitigation may or may not be appropriate to ensure the least practicable adverse impact on species or stocks and their habitat, as well as subsistence uses where applicable, NMFS considers 2 primary factors:
(1) The manner in which, and the degree to which, the successful implementation of the measure(s) is expected to reduce impacts to marine mammals, marine mammal species or stocks, and their habitat. This considers the nature of the potential adverse impact being mitigated ( e.g., likelihood, scope, range). It further considers the likelihood that the measure will be effective if implemented ( i.e., probability of accomplishing the mitigating result if implemented as planned), the likelihood of effective implementation ( i.e., probability of being implemented as planned); and
(2) The practicability of the measures for applicant implementation, which may consider such things as cost and impact on operations.
The mitigation measures described in the following sections would apply to the USACE in-water construction activities.

Shutdown, Harassment, and Monitoring Zones
USACE will employ shutdown, harassment, and monitoring zones in order to mitigate harm to marine mammals. Shutdown zones are areas in which pile driving will stop if any marine mammal enters and are pictured/identified in table 15. In most impact and pile driving scenarios, the shutdown zones exceed the calculated Level A isopleths, meaning that no marine mammal is expected to enter a shutdown zone except during impact pile driving of 24-in steel piles for phocids ( e.g. harbor seals) when the calculated Level A harassment isopleth (130.6 m) exceeds the 50-m shutdown zone. There was concern that the potential for seals to enter into a shutdown zone of 130 m would result in frequent delays and could impede the project's schedule. The shutdown zone will be established at 50 m for phocid pinnipeds during impact driving of 24-in steel piles to provide adequate protection without unnecessary delay, thereby meeting the statutory “practicable” standard.
Table 15—Shutdown Zones and Level B Monitoring Zones by Activity
Pile size and type | Shutdown zone (m) | Phocid | Otariid | Level B harassment (m)
Vibratory Pile driving
24-in steel pile | 50 | 15 | 3,981.1
12-in timber pile | 60 | 20 | 6,309.6
Impact pile driving
24-in steel pile | 50 | 50 | 464.2
12-in timber pile | 15 | 15 | 21.5
Prior to pile driving, PSOs will survey the shutdown zones shown in table 15 and surrounding areas for at least 30 minutes before pile driving activities start. If marine mammals are found within the shutdown zone, pile driving will be delayed until the animal has moved out of the shutdown zone, either verified by a PSO or by waiting until 15 minutes has elapsed without a sighting. If a marine mammal approaches or enters the shutdown zone during pile driving, the activity will be halted. Pile driving may resume after the animal has moved out of the shutdown zone or after at least 15 minutes has passed since the last observation of the animal.
All marine mammals will be monitored in the Level B harassment zone to the extent of visibility for the on-duty PSOs. If a marine mammal for which take is authorized enters the Level B harassment zone, in-water activities will continue and PSOs would document the animal's presence within the estimated harassment zone.
If a species for which authorization has not been granted, or for which the authorized takes are met, is observed approaching or within the Level B harassment zone, pile driving activities will be shut down immediately. Activities would not resume until the animal has been confirmed to have left the area or 15 minutes has elapsed with no sighting of the animal. If a Shutdown Zone is obscured by fog or other weather/sea conditions that restrict the observers' ability to observe, pile driving will not be initiated or would cease until the entire Shutdown Zone is visible so that monitoring may resume.

PSOs
The placement of PSOs during all pile driving and removal activities (described in detail in the Monitoring and Reporting section and Marine Mammal Monitoring Plan) will ensure that the project area is monitored to the maximum extent possible based on the required number of PSOs, required monitoring locations, and environmental conditions.

Pre- and Post-Activity Monitoring
Monitoring must take place from 30 minutes prior to initiation of pile driving activities ( i.e., pre-clearance monitoring) through 30 minutes post-completion of pile driving. Prior to the start of daily in-water construction activity, or whenever a break in pile driving of 30 minutes or longer occurs, PSOs will observe the shutdown and monitoring zones for a period of 30 minutes. The shutdown zone will be considered cleared when a marine mammal has not been observed within the zone for a 30-minute period. If a marine mammal is observed within the shutdown zones, pile driving activity will be delayed or halted. If work ceases for more than 30 minutes, the pre-activity monitoring of the shutdown zones will commence. A determination that the shutdown zone is clear must be made during a period of good visibility ( i.e., the entire shutdown zone and surrounding waters must be visible to the naked eye).

Bubble Curtain
A bubble curtain must be employed during all impact pile driving activities. The bubble curtain must distribute air bubbles around 100 percent of the piling circumference for the full depth of the water column. The lowest bubble ring must be in contact with the mudline for the full circumference of the ring. The weights attached to the bottom ring must ensure 100 percent substrate contact. No parts of the ring or other objects may prevent full substrate contact. Air flow to the bubblers must be balanced around the circumference of the pile.

Soft Start
Soft-start procedures are believed to provide additional protection to marine mammals by providing warning and/or giving marine mammals a chance to leave the area prior to the impact hammer operating at full capacity. For impact driving, an initial set of three strikes will be made by the hammer at reduced energy, followed by a 30-second waiting period, then 2 subsequent 3-strike sets before initiating continuous driving. Soft start will be implemented at the start of each day's impact pile driving and at any time following cessation of impact pile driving for a period of 30 minutes or longer.
Based on our evaluation of the applicant's planned measures, NMFS has determined that the required mitigation measures provide the means of effecting the least practicable impact on the affected species or stocks and their habitat, paying particular attention to rookeries, mating grounds, and areas of similar significance.

Monitoring and Reporting
In order to issue an LOA for an activity, section 101(a)(5)(A) of the MMPA states that NMFS must set forth requirements pertaining to the monitoring and reporting of such taking. The MMPA implementing regulations at 50 CFR 216.104(a)(13) indicate that requests for authorizations must include the suggested means of accomplishing the necessary monitoring and reporting that will result in increased knowledge of the species and of the level of taking or impacts on populations of marine mammals that are expected to be present while conducting the activities. Effective reporting is critical both to compliance as well as ensuring that the most value is obtained from the required monitoring.
Monitoring and reporting requirements prescribed by NMFS should contribute to improved understanding of one or more of the following:
• Occurrence of marine mammal species or stocks in the area in which take is anticipated ( e.g., presence, abundance, distribution, density);
• Nature, scope, or context of likely marine mammal exposure to potential stressors/impacts (individual or cumulative, acute or chronic), through better understanding of (1) action or environment ( e.g., source characterization, propagation, ambient noise), (2) affected species ( e.g., life history, dive patterns), (3) co-occurrence of marine mammal species with the activity, or (4) biological or behavioral context of exposure ( e.g., age, calving, or feeding areas);
• Individual marine mammal responses (behavioral or physiological) to acoustic stressors (acute, chronic, or cumulative), other stressors, or cumulative impacts from multiple stressors;
• How anticipated responses to stressors impact either long-term fitness and survival of individual marine mammals or populations, species, or stocks;
• Effects on marine mammal habitat ( e.g., marine mammal prey species, acoustic habitat, or other important physical components of marine mammal habitat); and
• Mitigation and monitoring effectiveness.

Visual Monitoring
Marine mammal monitoring during pile driving and removal associated with this project must be conducted by NMFS-approved PSOs as follows:
• PSOs must be independent of the contractor employed by USACE to conduct the project ( e.g., employed by a subcontractor) and have no other assigned tasks during monitoring periods;
• At least one PSO must have prior experience performing the duties of a PSO during construction activity pursuant to a NMFS-issued incidental take authorization;
• Other PSOs may substitute education ( i.e., degree in biological science or related field) or training for prior experience performing the duties of a PSO during construction activity pursuant to a NMFS-issued incidental take authorization;
• Where a team of three or more PSOs is required, a lead observer or monitoring coordinator must be designated. The lead observer must have prior experience performing the duties of a PSO during construction activity pursuant to a NMFS-issued incidental take authorization;
• PSOs must record all observations of marine mammals as described in the Marine Mammal Monitoring Plan, regardless of distance from the pile being driven. PSOs shall document any behavioral reactions in concert with distance from piles being driven or removed.
PSOs must have the following additional qualifications:
• Ability to conduct field observations and collect data according to assigned protocols;
• Experience or training in the field identification of marine mammals, including the identification of behaviors;
• Sufficient training, orientation, or experience with the construction operation to provide for personal safety during observations;
• Writing skills sufficient to prepare a report of observations including but not limited to: (1) the number and species of marine mammals observed; (2) dates and times when in-water construction activities were conducted; (3) dates, times, and reason for implementation of mitigation (or why mitigation was not implemented when required); and (4) marine mammal behavior; and
• Ability to communicate orally, by radio or in person, with project personnel to provide real-time information on marine mammals observed in the area as necessary.
The USACE must employ a minimum of two PSOs. PSO locations will provide an unobstructed view of all water within the shutdown zone(s) and as much of the Level A harassment and Level B harassment zones as possible. PSOs will be stationed along the shore of the LCR. One will be located on the closest shoreline or construction barge adjacent to planned pile driving and another observer could be stationed on a publicly accessible shoreline with a different vantage point of the disturbance area or be boat-based.
The USACE will ensure that construction supervisors and crews, the monitoring team, and relevant USACE staff are trained prior to the start of activities subject to the LOA, so that responsibilities, communication procedures, monitoring protocols, and operational procedures are clearly understood. New personnel joining during the project will be trained prior to commencing work. Monitoring will occur for all in-water pile driving activities during the pile installation work window (November 1 to February 28 (or February 29 in a leap year).

Data Collection
PSOs will use approved data forms to record the following information:
• Dates and times (beginning and end) of all marine mammal monitoring;
• PSO locations during marine mammal monitoring;
• Construction activities occurring during each daily observation period, including how many and what type of piles were driven or removed and by what method ( i.e., vibratory, impact);
• Weather parameters and water conditions;
• The number of marine mammals observed, by species, relative to the pile location and if pile driving or removal was occurring at time of sighting;
• Distance and bearings of each marine mammal observed to the pile being driven or removed;
• Description of marine mammal behavior patterns, including direction of travel;
• Age and sex class, if possible, of all marine mammals observed; and
• Detailed information about implementation of any mitigation triggered ( e.g., shutdowns and delays), a description of specific actions that ensued, and resulting behavior of the animal if any.

Reporting
The USACE must submit a draft monitoring report to NMFS within 90 calendar days of the completion of each construction year. A draft comprehensive 5-year summary report must also be submitted to NMFS within 90 days of the end of the effective period of the LOA. The reports must detail the monitoring protocol and summarize the data recorded during monitoring. Final annual reports and the final comprehensive report must be prepared and submitted within 30 days following resolution of any NMFS comments on the draft report. If no comments are received from NMFS within 30 days of receipt of the draft report, the report must be considered final. If comments are received, a final report addressing NMFS comments must be submitted within 30 days after receipt of comments. The marine mammal report would include an overall description of work completed, a narrative regarding marine mammal sightings, and associated PSO data sheets. Specifically, the report must include:
• Dates and times (begin and end) of all marine mammal monitoring;
• Construction activities occurring during each daily observation period, including the number and type of piles driven or removed and by what method ( i.e., vibratory driving) and the total equipment duration for cutting for each pile;
• PSO locations during marine mammal monitoring;
• Environmental conditions during monitoring periods (at beginning and end of PSO shift and whenever conditions change significantly), including Beaufort sea state and any other relevant weather conditions including cloud cover, fog, sun glare, and overall visibility to the horizon, and estimated observable distance;
• Upon observation of a marine mammal, the following information: (1) name of PSO who sighted the animal(s) and PSO location and activity at time of sighting; (2) time of sighting; (3) identification of the animal(s) ( e.g., genus/species, lowest possible taxonomic level, or unidentified), PSO confidence in identification, and the composition of the group if there is a mix of species; (4) distance and bearing of each marine mammal observed relative to the pile being driven for each sighting (if pile driving was occurring at time of sighting); (5) estimated number of animals (min/max/best estimate); (6) estimated number of animals by cohort ( e.g., adults, juveniles, neonates, group composition, etc. ); (7) animal's closest point of approach and estimated time spent within the harassment zone; and (8) description of any marine mammal behavioral observations ( e.g., observed behaviors such as feeding or traveling), including an assessment of behavioral responses thought to have resulted from the activity ( e.g., no response or changes in behavioral state such as ceasing feeding, changing direction, flushing, or breaching);
• Number of marine mammals detected within the harassment zones, by species; and
• Detailed information about any implementation of any mitigation triggered ( e.g., shutdowns and delays), a description of specific actions that ensued, and resulting changes in behavior of the animal(s), if any.

Reporting Injured or Dead Marine Mammals
In the event that personnel involved in the construction activities discover an injured or dead marine mammal, the USACE will report the incident to the Office of Protected Resources (OPR), NMFS, and to the West Coast regional stranding network as soon as feasible. If the death or injury was clearly caused by the specified activity, the USACE must immediately cease the specified activities until NMFS is able to review the circumstances of the incident and determine what, if any, additional measures are appropriate to ensure compliance with the terms of the LOA. The USACE must not resume their activities until notified by NMFS. The report must include the following information:
• Time, date, and location (latitude/longitude) of the first discovery (and updated location information if known and applicable);
• Species identification (if known) or description of the animal(s) involved;
• Condition of the animal(s) (including carcass condition if the animal is dead);
• Observed behaviors of the animal(s), if alive;
• If available, photographs or video footage of the animal(s); and
• General circumstances under which the animal was discovered.

Negligible Impact Analysis and Determination
NMFS has defined negligible impact as “an impact resulting from the specified activity that cannot be reasonably expected to, and is not reasonably likely to, adversely affect the species or stock through effects on annual rates of recruitment or survival” (50 CFR 216.103). A negligible impact finding is based on the lack of likely adverse effects on annual rates of recruitment or survival ( i.e., population-level effects). An estimate of the number of takes alone is not enough information on which to base an impact determination. In addition to considering estimates of the number of marine mammals that might be “taken” through harassment, NMFS considers other factors, such as the likely nature of any impacts or responses ( e.g., intensity, duration), the context of any impacts or responses ( e.g., critical reproductive time or location, foraging impacts affecting energetics), as well as effects on habitat, and the likely effectiveness of the mitigation. We also assess the number, intensity, and context of estimated takes by evaluating this information relative to population status. Consistent with the 1989 preamble for NMFS' implementing regulations (54 FR 40338, September 29, 1989), the impacts from other past and ongoing anthropogenic activities are incorporated into this analysis via their impacts on the baseline ( e.g., as reflected in the regulatory status of the species, population size and growth rate where known, ongoing sources of human-caused mortality, or ambient noise levels).
The analysis that follows applies to California sea lions, Steller sea lions, and harbor seals, given that the anticipated effects of this activity on these different marine mammal stocks are expected to be similar since they have comparable behavioral sensitivities and, therefore, no meaningful differences in terms of likely impacts. There is little information about the nature or severity of the impacts, or the size, status, or structure of any of these species or stocks that would lead to a different analysis for this activity as regards the different species.
Vibratory and impact pile driving activities have the potential to disturb or displace marine mammals. Specifically, the project activities may result in take, in the form of Level A harassment and Level B harassment from underwater sounds generated from pile driving and removal. Potential takes could occur if individuals are present in the ensonified zone when these activities are underway.
The takes from Level B harassment would be due to potential behavioral disturbance and TTS. Level A harassment takes would be due to auditory injury. No mortality or serious injury is anticipated given the nature of the activity, even in the absence of the required mitigation. The potential for harassment is minimized through the construction method and the implementation of the required mitigation measures (see Mitigation section).
Take would occur within a limited, confined area (the LCR) of the stocks' ranges. The duration and intensity of authorized harassment events would be minimized through use of mitigation measures described herein. Further, the amount of take authorized is small when compared to stock abundance, and the project is not anticipated to impact any known important habitat areas for any marine mammal species.
Take by Level A harassment is authorized for a single species (harbor seal) to account for the potential that an animal could enter and remain within the area between a Level A harassment zone and the shutdown zone for a duration long enough to experience a take via Level A harassment. Limited take by Level A harassment is expected to arise from, at most, a small degree of auditory injury during impact driving, which will only be used briefly to achieve the final 5-ft (1.5 m) of embedment depth for a given pile. Animals would need to be exposed to higher levels and/or longer duration in order to incur any more than a small degree of auditory injury. Additionally, and as noted previously, some subset of the individuals that are behaviorally harassed could also simultaneously incur some small degree of TTS for a short duration of time. Because of the small degree anticipated, though, any auditory injury or TTS potentially incurred here would not be expected to adversely impact individual fitness, let alone annual rates of recruitment or survival.
Marine mammal behavioral responses to pile driving, if any, are expected to be mild and temporary. Marine mammals found within the Level B harassment zone may not show any visual cues they are disturbed by activities or they could become alert, avoid the area, leave the area, or display other mild responses that are not observable such as changes in vocalization patterns. Given the limited number of piles to be installed per day and that pile driving would occur across a range of 1 to 51 days between November 1 and February 28 or February 29 in a leap year over the 5-year effective period of the LOA, the effects of any harassment would be temporary.
Impacts on marine mammal prey that would occur during the USACE's planned activity would have, at most, short-term effects on foraging of individual marine mammals and likely no effect on the populations of marine mammals as a whole. Indirect effects on marine mammal prey during the construction are expected to be minor, and these effects are unlikely to cause substantial effects on marine mammals at the individual level, with no expected effect on annual rates of recruitment or survival.
In addition, it is unlikely that minor noise effects in a small, localized area of habitat would have any effect on the stocks' annual rates of recruitment or survival. In combination, we believe that these factors, as well as the available body of evidence from other similar activities, demonstrate that the potential effects of the specified activities will have only minor, short-term effects on individuals. The specified activities are not expected to impact rates of recruitment or survival and will therefore not result in population-level impacts.
In summary and as described above, the following factors primarily support our determination that the impacts resulting from this activity are not expected to adversely affect any of the species or stocks through effects on annual rates of recruitment or survival:
• No serious injury or mortality is anticipated or authorized;
• The intensity of anticipated takes by Level B harassment is relatively low for all stocks and would not be of a duration or intensity expected to result in impacts on reproduction or survival;
• No important habitat areas have been identified within the project area;
• For species authorized for take, the project area is a very small and peripheral part of their range and anticipated habitat impacts are minor;
• The USACE would implement mitigation measures, such as bubble curtains and soft-starts for impact pile driving; and
• Monitoring and shutdowns would minimize the numbers of marine mammals exposed to injurious levels of sound to ensure that take by Level A harassment would result, at most, in a small degree of auditory injury.
Based on the analysis contained herein of the likely effects of the specified activity on marine mammals and their habitat, and taking into consideration the implementation of the required monitoring and mitigation measures, NMFS finds that the total marine mammal take from the planned activity will have a negligible impact on all affected marine mammal species or stocks.

Small Numbers
As noted previously, only take of small numbers of marine mammals may be authorized under sections 101(a)(5)(A) and (D) of the MMPA for specified activities other than military readiness activities. The MMPA does not define small numbers and so, in practice, where estimated numbers are available, NMFS compares the maximum number of individuals taken in any year to the most appropriate estimation of abundance of the relevant species or stock in our determination of whether an authorization is limited to small numbers of marine mammals. When the predicted maximum annual number of individuals to be taken is fewer than one-third of the species or stock abundance, the take is considered to be of small numbers. See 86 FR 5322, 5439 (Jan. 19, 2021). Additionally, other qualitative factors may be considered in the analysis, such as the temporal or spatial scale of the activities.
Table 14 demonstrates the maximum number of Level A and Level B harassment events per year. Our analysis shows that no more than 29.6 percent of harbor seals, 3.6 percent of California sea lions and less than 0.01 percent of Steller sea lions could be taken by Level A and Level B harassment. The numbers of animals authorized to be taken for these stocks would be considered small relative to the relevant stock's abundances, even if each estimated taking occurred to a new individual—an extremely unlikely scenario.
Based on the analysis contained herein of the planned activity (including the required mitigation and monitoring measures) and the anticipated take of marine mammals, NMFS finds that small numbers of marine mammals would be taken relative to the population size of the affected species or stocks.

Unmitigable Adverse Impact Analysis and Determination
There are no relevant subsistence uses of the affected marine mammal stocks or species implicated by this action. Therefore, NMFS has determined that the total taking of affected species or stocks would not have an unmitigable adverse impact on the availability of such species or stocks for taking for subsistence purposes.

Adaptive Management
The regulations governing the take of marine mammals incidental to the USACE's construction activities contains an adaptive management component. The reporting requirements associated with this rule are designed to provide NMFS with monitoring data from completed projects to allow consideration of whether any changes are appropriate. The use of adaptive management allows NMFS to consider new information from different sources to determine (with input from the USACE regarding practicability) on an annual or biennial basis if mitigation or monitoring measures should be modified (including additions or deletions). Mitigation measures could be modified if new data suggests that such modifications would have a reasonable likelihood of reducing adverse effects to marine mammals and if the measures are practicable.
The following are some of the possible sources of applicable data could be considered through the adaptive management process: (1) results from monitoring reports, as required by MMPA authorizations; (2) results from general marine mammal and sound research; and (3) any information which reveals that marine mammals may have been taken in a manner, extent, or number not authorized by these regulations or LOAs issues pursuant to these regulations. See § 217.77(c) below.

National Environmental Policy Act
To comply with NEPA (42 U.S.C. 4321 et seq. ) and NOAA Administrative Order (NAO) 216-6A, NMFS must review our action ( i.e., promulgation of regulations and subsequent issuance of a 5-year LOA) with respect to potential impacts on the human environment.
This action is consistent with categories of activities identified in Categorical Exclusion B4 (IHAs with no anticipated serious injury or mortality) of the Companion Manual for NAO 216-6A, which do not individually or cumulatively have the potential for significant impacts on the quality of the human environment and for which we have not identified any extraordinary circumstances that would preclude this categorical exclusion. Accordingly, NMFS has determined that the action qualifies to be categorically excluded from further review under NEPA.

Endangered Species Act
Section 7(a)(2) of the ESA of 1973 (16 U.S.C. 1531 et seq. ) requires that each Federal agency insure that any action it authorizes, funds, or carries out is not likely to jeopardize the continued existence of any endangered or threatened species or result in the destruction or adverse modification of designated critical habitat. To ensure ESA compliance for the issuance of incidental take authorizations, NMFS consults internally whenever NMFS authorizes take for endangered or threatened species.
No incidental take of ESA-listed species is authorized or expected to result from this activity. Therefore, NMFS has determined that formal consultation under section 7 of the ESA is not required for this action.

Classification
The Office of Management and Budget has determined that this rule is not significant for purposes of Executive Order 12866.
Pursuant to section 605(b) of the Regulatory Flexibility Act (RFA), the Chief Counsel for Regulation of the Department of Commerce certified to the Chief Counsel for Advocacy of the Small Business Administration at the proposed rule stage that this action will not have a significant economic impact on a substantial number of small entities. No comments were received regarding this certification or on the economic impacts of the rule more generally. As a result, a regulatory flexibility analysis is not required and none has been prepared.
This rule does not contain a collection-of-information requirement subject to the provisions of the Paperwork Reduction Act because the applicant is a Federal agency.

List of Subjects in 50 CFR 217
Acoustics, Administrative practice and procedure, Construction, Endangered and threatened species, Marine mammals, Mitigation and Monitoring requirements, Reporting requirements, and Wildlife.
Dated: May 5, 2025.
Samuel D. Rauch, III,

Deputy Assistant Administrator for Regulatory Programs, National Marine Fisheries Service.
For the reasons set forth in the preamble, NMFS amends 50 CFR part 217 as follows:

PART 217—REGULATIONS GOVERNING THE TAKE OF MARINE MAMMALS INCIDENTAL TO SPECIFIED ACTIVITIES
1. The authority citation for part 217 continues to read as follows:

Authority:
16 U.S.C. 1361 et seq., unless otherwise noted.
2. Add subpart H to read as follows:

Subpart H—Taking Marine Mammals Incidental to the Lower Columbia River Dredged Material Management Plan, Oregon and Washington
Sec.
217.70
Specified activity and geographical region.
217.71
Effective dates.
217.72
Permissible methods of taking.
217.73
Prohibitions.
217.74
Mitigation requirements.
217.75
Requirements for monitoring and reporting.
217.76
Letters of Authorization.
217.77
Renewals and modifications of Letters of Authorization.
217.78-217.279
[Reserved]
§ 217.70
Specified activity and geographical region.
(a) Regulations in this subpart apply only to the United States Army Corps of Engineers (USACE) and those persons it authorizes or funds to conduct construction activities, including maintenance and replacement of piles, as designated in the Lower Columbia River Dredged Material Management Plan, Oregon and Washington on its behalf that result in the incidental taking of marine mammals that occur in the areas outlined in paragraph (b) of this section. Requirements imposed on the USACE pursuant to this subpart must be implemented by those persons it authorizes or funds to conduct activities on its behalf.
(b) The taking of marine mammals by the USACE may be authorized in a Letter of Authorization (LOA) only if it occurs near the Mouth of the Columbia River in Oregon and Washington.
§ 217.71
Effective dates.
Regulations in this subpart are effective from November 1, 2027, through February 29, 2032.
§ 217.72
Permissible methods of taking.
Under an LOA issued pursuant to § 216.106 of this chapter and § 217.76, the Holder of the LOA (hereinafter “USACE”) may incidentally, but not intentionally, take marine mammals within the area described in § 217.70 (b) by harassment associated with construction activities, provided the activity is in compliance with all terms, conditions, and requirements of the regulations in this subpart and the applicable LOA.
§ 217.73
Prohibitions.
(a) It is unlawful for any person to do any of the following in connection with the activities described in § 217.70:
(1) Violate, or fail to comply with, the terms, conditions, and requirements of this subpart or a LOA issued under this subpart;
(2) Take any marine mammal not specified in such LOA;
(3) Take any marine mammal specified in such LOA in any manner other than as specified;
(4) Take a marine mammal specified in such LOA after NMFS determines such taking results in more than a negligible impact on the species or stocks of such marine mammal; or
(5) Take a marine mammal specified in such LOA after NMFS determines such taking results in an unmitigable adverse impact on the species or stock of such marine mammal for taking for subsistence uses.
(b) [Reserved]
§ 217.74
Mitigation requirements.
(a) When conducting the activities identified in § 217.70(a), the mitigation measures contained in any LOA issued under this subpart must be implemented. These mitigation measures include but are not limited to:
(1) A copy of the LOA must be in the possession of the USACE, supervisory construction personnel, lead protected species observers (PSOs), and any other relevant designees of the USACE operating under the authority of the LOA at all times that activities subject to the LOA are being conducted.
(2) The USACE shall conduct training for supervisors and crews, the PSO team, and relevant USACE staff prior to the start of construction activity subject to this rule, so that responsibilities, communication procedures, monitoring protocols, and operational procedures are clearly understood. New personnel joining during the project must be trained in the aforementioned matters prior to commencing work.
(3) The USACE must employ PSOs and establish monitoring locations as described in the Marine Mammal Monitoring Plan. The USACE must monitor the harassment zones to the maximum extent possible based on the required number of PSOs, required monitoring locations, and environmental conditions.
(4) Monitoring must take place from 30 minutes prior to initiation of pile driving activity ( i.e., pre-start clearance monitoring) through 30 minutes post-completion of pile driving activity.
(5) Pre-start clearance monitoring must be conducted during periods of visibility sufficient for the lead PSO to determine that the shutdown zones are clear of marine mammals. Pile driving may commence following 30 minutes of diligent observation after which it is determined that the shutdown zones are clear of marine mammals.
(6) For all pile driving activity, the USACE must implement shutdown zones with radial distances as identified in a LOA issued under this subpart.
(7) If a marine mammal is observed entering or within the shutdown zones, pile driving activity must be delayed or halted. Pile driving must be commenced or resumed as described in § 217.74(a)(8).
(8) If pile driving is delayed or halted due to the presence of a marine mammal, the activity may not commence or resume until either the animal has voluntarily exited and been visually confirmed to be beyond the shutdown zone or 15 minutes have passed without re-detection of the animal within the shutdown zone.
(9) The USACE must avoid direct physical interaction with marine mammals during construction activity. If a marine mammal comes within 15 m of such activity, operations must cease and vessels must reduce speed to the minimum level required to maintain steerage and safe working conditions, as necessary, to avoid direct physical interaction.
(10) The USACE must use soft start techniques when impact pile driving. Soft start requires contractors to provide an initial set of three strikes from the hammer at reduced energy, followed by a 30-second waiting period. Then two subsequent reduced-energy strike sets would occur. A soft start must be implemented at the start of each day's impact pile driving and at any time following cessation of impact pile driving for a period of 30 minutes or longer.
(11) The USACE must employ bubble curtain systems during all impact driving except where the water depth is less than 0.67 m (2 ft) in depth. Bubble curtains must meet the following requirements:
(i) The bubble curtain must distribute air bubbles around 100 percent of the piling perimeter for the full depth of the water column.
(ii) The lowest bubble ring must be in contact with the mudline and/or rock bottom for the full circumference of the ring, and the weights attached to the bottom ring shall ensure 100 percent mudline and/or rock bottom contact. No parts of the ring or other objects shall prevent full mudline and/or rock bottom contact.
(iii) The bubble curtain must be operated such that there is equal balancing of air flow to all bubblers.
(12) For all pile driving activities, land-based PSOs must be stationed at the best vantage points practicable to monitor for marine mammals and implement shutdown/delay procedures.
(13) Pile driving activity must be halted upon observation of a species for which either incidental take is not authorized or the authorized number of takes has been met entering or within the harassment zone.
(b) [Reserved]
§ 217.75
Requirements for monitoring and reporting.
(a) The USACE must submit a Marine Mammal Monitoring Plan (Monitoring Plan) to NMFS for approval at least 90 days in advance of construction. Marine mammal monitoring must be conducted in accordance with the conditions in this section and the approved Monitoring Plan.
(b) Monitoring must be conducted by qualified, NMFS-approved PSOs, in accordance with the following conditions:
(1) PSOs must be independent of the activity contractor (for example, employed by a subcontractor) and have no other assigned tasks during monitoring periods.
(2) At least one PSO must have prior experience performing the duties of a PSO during construction activity pursuant to a NMFS-issued incidental take authorization.
(3) Other PSOs may substitute other relevant experience, education ( i.e., degree in biological science or related field), or training for prior experience performing the duties of a PSO during construction activity pursuant to a NMFS-issued incidental take authorization.
(4) Where a team of three or more PSOs is required, a lead observer or monitoring coordinator must be designated. The lead observer must have prior experience performing the duties of a PSO during construction activity pursuant to a NMFS-issued incidental take authorization.
(5) PSOs must record all observations of marine mammals as described in the Monitoring Plan, regardless of distance from the pile being driven. PSOs shall document any behavioral reactions in concert with distance from piles being driven or removed.
(c) The USACE must establish monitoring locations as described in the Monitoring Plan. For all pile driving activities, a minimum of 1 PSO must be assigned to each active pile driving location to monitor the shutdown zones.
(d) The USACE must submit a draft monitoring report to NMFS within 90 calendar days of the completion of each construction year. A draft comprehensive 5-year summary report must also be submitted to NMFS within 90 days of the end of the project. The reports must detail the monitoring protocol and summarize the data recorded during monitoring. If no comments are received from NMFS within 30 days of receipt of the draft reports, the reports must be considered final. If comments are received, final annual reports and the final comprehensive report addressing NMFS comments must be submitted within 30 days after receipt of comments. The reports must contain the informational elements described at minimum below including:
(1) Dates and times (beginning and end) of all marine mammal monitoring;
(2) Construction activities occurring during each daily observation period, including how many and what type of piles were driven or removed, by what method ( i.e., impact or vibratory), the total duration of driving time for each pile (vibratory driving), and number of strikes for each pile (impact driving);
(3) PSO locations during marine mammal monitoring;
(4) Environmental conditions during monitoring periods (at beginning and end of PSO shift and whenever conditions change significantly), including Beaufort sea state, and any other relevant weather conditions including cloud cover, fog, sun glare, and overall visibility to the horizon, and estimated observable distance (if less than the harassment zone distance);
(5) Upon observation of a marine mammal, the following information should be collected:
(i) PSO who sighted the animal, PSO location, and construction activity at time of sighting:
(ii) Time of sighting;
(iii) Identification of the animal(s) ( e.g., genus/species, lowest possible taxonomic level, or unidentified), PSO confidence in identification, and the composition of the group if there is a mix of species;
(iv) Distances and bearings of each marine mammal observed in relation to the pile being driven for each sighting (if pile driving was occurring at time of sighting);
(v) Minimum, maximum, and best estimated number of animals;
(vi) Estimated number of animals by cohort (adults, juveniles, neonates, group composition, etc. );
(vii) Animal's closest point of approach and estimated time spent within the harassment zone;
(viii) Description of any marine mammal behavioral observations ( e.g., feeding or traveling), including an assessment of behavioral responses to the construction activity ( e.g., no response or changes in behavioral state such as ceasing feeding, changing direction, flushing, or breaching);
(ix) Number of marine mammals detected within the harassment zones by species.
(x) Detailed information about any implementation of any mitigation ( e.g., shutdowns and delays), a description of specific actions that ensued, and resulting changes in the behavior of the animal, if any; and
(xi) All PSO datasheets and/or raw sightings data.
(e) In the event that personnel involved in the construction activities discover an injured or dead marine mammal, the USACE must report the incident to NMFS Office of Protected Resources (OPR) and to the West Coast Regional Stranding Coordinator as soon as feasible. If the death or injury was caused by the specified activity, the USACE must immediately cease the specified activities until NMFS OPR is able to review the circumstances of the incident and determine what, if any, additional measures are appropriate to ensure compliance with the terms of this rule and the LOA issued under § 216.106 and § 217.76. The USACE must not resume their activities until notified by NMFS. The report must include the following information:
(1) Time, date, and location (latitude/longitude) of the first discovery (and updated location information if known and applicable);
(2) Species identification (if known) or description of the animal(s) involved;
(3) Condition of the animal(s) (including carcass condition if the animal is dead);
(4) Observed behaviors of the animal(s), if alive;
(5) If available, photographs or video footage of the animal(s); and
(6) General circumstances under which the animal was discovered.
§ 217.76
Letters of Authorization.
(a) To incidentally take marine mammals pursuant to these regulations, the USACE must apply for and obtain an LOA.
(b) An LOA, unless suspended or revoked, may be effective for a period of time not to exceed the expiration date of these regulations.
(c) If an LOA expires prior to the expiration date of these regulations, the USACE may apply for and obtain a renewal of the LOA.
(d) In the event of projected changes to the activity or to mitigation and monitoring measures required by an LOA, the USACE must apply for and obtain a modification of the LOA as described in § 217.77.
(e) The LOA must set forth the following information:
(1) Permissible methods of incidental taking;
(2) Means of effecting the least practicable adverse impact ( i.e., mitigation) on the species, its habitat, and on the availability of the species for subsistence uses; and
(3) Requirements for monitoring and reporting.
(f) Issuance of the LOA must be based on a determination that the level of taking will be consistent with the findings made for the total taking allowable under these regulations.
(g) Notice of issuance or denial of an LOA must be published in the Federal Register within 30 days of a determination.
§ 217.77
Renewals and modifications of Letters of Authorization.
(a) An LOA issued under § 216.106 of this chapter and § 217.76 for the activity identified in § 217.70(a) may be renewed or modified upon request by the applicant, provided that:
(1) The specified activity and mitigation, monitoring, and reporting measures, as well as the anticipated impacts, are the same as those described and analyzed for these regulations; and
(2) NMFS determines that the mitigation, monitoring, and reporting measures required by the previous LOA under these regulations were implemented.
(b) For LOA modification or renewal requests by the applicant that include changes to the activity or the mitigation, monitoring, or reporting that do not change the findings made as the basis of these regulations or result in no more than a minor change in the total estimated number of takes (or distribution by species or years), NMFS may publish a notice of proposed LOA in the Federal Register , including the associated analysis of the change, and solicit public comment before issuing the LOA.
(c) An LOA issued under § 216.106 of this chapter and § 217.76 for the activity identified in § 217.70 (a) may be modified by NMFS under the following circumstances:
(1) NMFS may modify (including augment) the existing mitigation, monitoring, or reporting measures (after consulting with USACE regarding the practicability of the modifications) if doing so creates a reasonable likelihood of more effectively accomplishing the goals of the mitigation and monitoring set forth in the preamble for these regulations;
(i) Possible sources of data that could contribute to the decision to modify the mitigation, monitoring, or reporting measures in an LOA:
(A) Results from USACE's monitoring from previous years;
(B) Results from other marine mammal and/or sound research or studies; and
(C) Any information that reveals marine mammals may have been taken in a manner, extent or number not authorized by these regulations or subsequent LOAs; and
(ii) If, through adaptive management, the modifications to the mitigation, monitoring, or reporting measures are substantial, NMFS must publish a notice of proposed LOA in the Federal Register and solicit public comment.
(2) If NMFS determines that an emergency exists that poses a significant risk to the well-being of the species or stocks of marine mammals specified in a LOA issued pursuant to § 216.106 of this chapter and § 217.76, a LOA may be modified without prior notice or opportunity for public comment. Notification would be published in the Federal Register within 30 days of the action.
§§ 217.78-217.79
[Reserved]
DEPARTMENT OF COMMERCE
National Oceanic and Atmospheric Administration
50 CFR Part 622
[Docket No. 140818679-5356-02; RTID 0648-XE873]
2025 Gulf Red Snapper Recreational For-Hire Fishing Season

AGENCY:
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.

ACTION:
Temporary rule; closure.

SUMMARY:
NMFS announces the 2025 recreational fishing season for the Federal charter vessel/headboat (for-hire) component for red snapper in the exclusive economic zone (EEZ) of the Gulf through this temporary rule. The red snapper recreational for-hire component in the Gulf EEZ opens on June 1, 2025, and will close at 12:01 a.m., local time, on September 16, 2025. This closure is necessary to prevent the Federal for-hire component from exceeding its quota and to prevent overfishing of the Gulf red snapper resource.

DATES:
The closure is effective at 12:01 a.m., local time, on September 16, 2025, until 12:01 a.m., local time, on January 1, 2026.

FOR FURTHER INFORMATION CONTACT:
Frank Helies, NMFS Southeast Regional Office, telephone: 727-209-5988, email: frank.helies@noaa.gov.

SUPPLEMENTARY INFORMATION:
The Gulf reef fish fishery, which includes red snapper, is managed under the Fishery Management Plan for the Reef Fish Resources of the Gulf (FMP). The Gulf Council prepared the FMP, which was approved by the Secretary of Commerce, and NMFS implements the FMP through regulations at 50 CFR part 622 under the authority of the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act).
Through this temporary rule, NMFS announces the recreational fishing season for the red snapper recreational sector for-hire component in the Gulf of America (Gulf) for the 2025 fishing year. Executive Order 14172, “Restoring Names That Honor American Greatness” (January 20, 2025), directs that the Gulf of Mexico be renamed the Gulf of America. Consistent with the order, this action uses Gulf of America to refer to the area known as the Gulf of Mexico in the specific regulations at 50 CFR part 622.
The final rule implementing Amendment 40 to the FMP established two components within the recreational sector fishing for Gulf red snapper: the private angling component and the Federal for-hire component (80 FR 22422, April 22, 2015). Amendment 40 also allocated the red snapper recreational annual catch limit (ACL; recreational quota) between the components and established separate seasonal closures for the two components. The Federal for-hire component's red snapper annual catch target (ACT) is 9 percent below the for-hire component quota (87 FR 74014, December 2, 2022; 50 CFR 622.41(q)(2)(iii)(B)).
The red snapper for-hire component seasonal closure is projected from the component's ACT. Projecting the for-hire component's seasonal closure using the ACT reduces the likelihood of the harvest exceeding the component quota and the total recreational quota. The Federal for-hire component ACT for red snapper in the Gulf EEZ is 3,076,322 pounds (1,395,396 kilograms), round weight (50 CFR 622.41(q)(2)(iii)(B)).
NMFS has determined that the 2025 Federal Gulf red snapper for-hire fishing season will be 107 days. NMFS considered season length projections based on average catch rates for 2020-2022, 2020-2024, and 2022-2024, and using only 2024 landings. NMFS determined that 107 days is likely to constrain harvest to the for-hire component ACT based on these historical catch rates, including the lower catch rates and the under harvest of the component ACT in 2024 (74 percent of the ACT). For details about the projection for 2025, see https://www.fisheries.noaa.gov/southeast/sustainable-fisheries/gulf-mexico-recreational-red-snapper-management. Therefore, the 2025 recreational season for the Federal for-hire component will begin at 12:01 a.m., local time, on June 1, 2025, and close at 12:01 a.m., local time, on September 16, 2025.
On and after the effective date of the Federal for-hire component closure, the bag and possession limits for red snapper for Federal for-hire vessels are zero. When the Federal for-hire component is closed, these bag and possession limits apply in the Gulf on board a vessel for which a valid Federal for-hire permit for Gulf reef fish has been issued, without regard to where such species were harvested, i.e., in state or Federal waters. In addition, a person aboard a vessel that has been issued a charter vessel/headboat permit for Gulf reef fish any time during the fishing year may not harvest or possess red snapper in or from the Gulf EEZ when the Federal charter vessel/headboat component is closed.

Classification
NMFS issues this action pursuant to section 305(d) of the Magnuson-Stevens Act. This action is taken under 50 CFR 622.41(q)(2)(i) and (ii), which was issued pursuant to section 304(b) of the Magnuson-Stevens Act, and is exempt from review under Executive Order 12866.
Pursuant to 5 U.S.C. 553(b)(B), there is good cause to waive prior notice and an opportunity for public comment on this action, as notice and comment is unnecessary and contrary to the public interest. Such procedures are unnecessary because the rule implementing the recreational red snapper quotas and ACTs, and the rule implementing the requirement to close the for-hire component when its ACT is projected to be reached have already been subject to notice and comment, and all that remains is to notify the public of the closure. Such procedures are contrary to the public interest because many for-hire operations book trips for clients in advance and require as much notice as NMFS is able to provide to adjust their business plans to account for the fishing season.

Authority:
16 U.S.C. 1801 et seq.
Dated: May 6, 2025.
Kelly Denit,

Director, Office of Sustainable Fisheries, National Marine Fisheries Service.
DEPARTMENT OF COMMERCE
National Oceanic and Atmospheric Administration
50 CFR Part 648
[Docket No. 250506-0079; RTID 0648-XE827]
Fisheries of the Northeastern United States; Atlantic Spiny Dogfish Fishery; 2025 Specifications

AGENCY:
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.

ACTION:
Final rule.

SUMMARY:
NMFS is implementing specifications for the 2025 Atlantic spiny dogfish fishery, as recommended by the Mid-Atlantic and New England Fishery Management Councils. This action is necessary to establish allowable harvest levels for the Atlantic spiny dogfish fishery to prevent overfishing while enabling optimum yield, using the best scientific information available.

DATES:
Effective May 9, 2025.

ADDRESSES:
Copies of the Supplemental Information Report (SIR) and other supporting documents for this action are available upon request from Dr. Christopher M. Moore, Executive Director, Mid-Atlantic Fishery Management Council, Suite 201, 800 North State Street, Dover, DE 19901. These documents are also accessible via the internet at: http://www.mafmc.org/supporting-documents.

FOR FURTHER INFORMATION CONTACT:
Laura Deighan, Fishery Policy Analyst, Laura.Deighan@noaa.gov or (978) 281-9184.

SUPPLEMENTARY INFORMATION:

Background
The Mid-Atlantic and New England Fishery Management Councils (collectively, the Councils) jointly manage the Atlantic Spiny Dogfish Fishery Management Plan (FMP), with the Mid-Atlantic Council serving as the administrative lead. Additionally, the Atlantic States Marine Fisheries Commission (Commission) manages the spiny dogfish fishery in state waters from Maine to North Carolina through a separate, interstate fishery management plan. The Federal FMP requires the specification of an acceptable biological catch (ABC), annual catch limit (ACL), annual catch target (ACT), total allowable landings (TAL), and a coastwide commercial quota. These limits and other related management measures may be set for up to five fishing years at a time, with each fishing year running from May 1 through April 30. This action implements Atlantic spiny dogfish specifications for fishing year 2025, as recommended by the Councils. The Commission voted to implement complementary specifications on February 4, 2025, during its winter meeting.
At their respective December 2024 meetings, both Councils voted to adopt 2025 spiny dogfish specifications using an ABC of 7,626 metric tons (mt), as provided by the Mid-Atlantic Council's Scientific and Statistical Committee (SSC) at its November 20, 2024, meeting. The Councils determined that a 50-percent probability of overfishing ( i.e., an ABC equal to the overfishing limit (OFL)) was an acceptable level of risk for the 2025 specifications given: (1) Industry testimony that reductions in the commercial quota risk the sustainability of the commercial spiny dogfish industry, and (2) that the stock is expected to increase to 113 percent of its biomass target in 2026 (from 101 percent in 2022) under these catch limits. After accounting for estimated catch from other sources ( i.e., Canadian landings, domestic discards, and recreational landings), this results in a commercial quota of 4,236 mt. This action includes no changes to other management measures, such as trip limits.
The proposed rule for this action published in the Federal Register on March 26, 2025 (90 FR 13724), and comments were accepted through April 10, 2025. NMFS received seven comments from the public, and no changes were made to the final rule because of those comments (see Comments and Responses for additional detail). Additional background information regarding the development of these specifications was provided in the proposed rule and is not repeated here.

Final 2025 Specifications
This action implements the Councils' recommendations for the 2025 Atlantic spiny dogfish catch specifications (table 1), which are consistent with the ABC provided by the Mid-Atlantic Council's SSC in November and the best available science. The resulting coastwide commercial quota is 4,236 mt, which is an 18-percent decrease from the initial 2024 commercial quota. It is a 9-percent decrease from the current 2024 commercial quota, which was reduced on September 30, 2024, (89 FR 79452) to account for an ACL overage in 2023. The decrease from 2024 is the result of a higher, corrected 2022 discard estimate; discards that were higher than expected in 2023; and a more precautionary discard estimate for 2025. This action makes no changes to the 7,500-pound (lb; 3,402-kilogram) trip limit.
Table 1—Final 2025 Atlantic Spiny Dogfish Fishery Specifications
| Million lb | Metric tons
ABC | 16.81 | 7,626
ACL = ACT | 16.8 | 7,622
TAL | 9.58 | 4,347
Commercial Quota | 9.34 | 4,236
While these specifications result in a reduction in the commercial quota, they are based on the highest ABC allowable under the National Standard 1 requirements that NMFS prevent overfishing with at least a 50-percent probability. The 2025 commercial quota is slightly higher than landings in recent years ( i.e., 8.5 million lb (3,855 mt) in 2023, with fishing year 2024 catch currently trending lower than that of 2023).

Comments and Responses
The public comment period for the proposed rule ended on April 10, 2025. Four individual members of the public, one non-governmental organization, and four commercial fishermen commented on the proposed rule. Three commercial fishermen submitted a single comment, resulting in seven unique comments. One comment from a member of the public was not germane to this action, and one comment from a member of the public did not provide sufficient context and information for NMFS to respond. In total, five unique comments were relevant to the action and are addressed below. No changes were made to the final rule as a result of these comments.
Comment 1: Four commercial fishermen opposed the reduction in the Atlantic spiny dogfish commercial quota. These commenters cited concerns about the impact of reduced quotas on an already declining industry, the risk that the industry may permanently lose access to some markets, the negative economic impact on associated industries ( e.g., shipping, processing), and the negative ecological impacts of increased spiny dogfish predation on other species under reduced quotas.
Response: National Standard 1 requires NMFS to prevent overfishing, and the National Standard 1 guidelines require at least a 50-percent probability of doing so. These specifications include the highest allowable ABC expected to prevent overfishing with a 50-percent probability. While the Mid-Atlantic Council's risk policy would typically require a lower ABC with a 46-percent probability of overfishing for a stock just above its target ( e.g., Atlantic spiny dogfish), the Councils took into account industry testimony regarding the potential economic impacts of quota reductions and set the specifications based on the highest allowable ABC.
To ensure the ABC is not exceeded, the specifications must consider expected catch from other sources when setting the commercial quota. The 2025 specifications use reasonable estimates for other sources of fishing mortality: The most recent three-year average of Canadian landings; the most recent five-year average of recreational landings; and a discard set-aside that is the mid-point of the most recent five-year average and the previously accepted “model-based projection” (generated by applying the 2022 ratio of discards to total catch to the year-specific ABC). The Atlantic Spiny Dogfish Committee recommended using the average of these two estimates as a reasonable approach to deal with uncertainty, as Atlantic spiny dogfish discards can be highly variable. The use of a lower and less precautionary discard estimate would result in a higher quota, but would increase the risk of an ACL overage in 2025. The Atlantic Spiny Dogfish FMP and regulations at 50 CFR 648.233(c) require a reduction in a future-year ACL, and thus the commercial quota, when an overage occurs. The 2025 commercial quota is intended to provide the industry with the highest allowable quota while minimizing the risk of a quota reduction in a future fishing year due to an ACL overage.
Comment 2: One commercial fisherman opposed to the specifications also stated that “take” should only include dogfish landings and not live discards.
Response: “Catch, take, or harvest” is defined under the Magnuson-Stevens Act as including, but is not limited to, “any activity that results in killing any fish or bringing any live fish on board a vessel” (§ 600.10). While “take” may be defined differently under other statutes, those definitions do not apply to these specifications or catch accounting within the Atlantic spiny dogfish fishery and are not discussed further.
The performance of the Atlantic spiny dogfish fishery is evaluated based on total dead catch ( i.e., commercial and recreational landings and dead discards). Live discards are not included in the calculation of total dead catch. The estimates of dead discards, and the methods used to calculate them, are considered the best scientific information available. First, observer data is used to generate ratios of Atlantic spiny dogfish discards-to-total-catch by stock area, gear, and mesh size annually. These ratios are applied to total catch reported on dealer reports to generate estimates of total Atlantic spiny dogfish discards ( i.e., both live and dead discards) by stock area and gear type. The estimated dead discards are then calculated by applying a stock area- and gear-specific discard mortality rate to the total discards by gear and area. This estimate of dead discards is included in the calculation of total dead catch that is compared to the catch limits.
Comment 3: Three commercial fishermen who opposed the specifications raised concerns with the information that factored into the 2025 quota being lower than that of 2024 ( i.e., the higher, corrected 2022 discard estimate; discards that were higher than expected in 2023; and a more precautionary discard estimate for 2025). Specifically, the commenters took issue with the use of discard estimates, rather than actual numbers. The commenters raised concerns with the correction to the 2022 discards and that the correction was made “3 years later.”
Response: When setting forward-looking specifications and commercial quotas ( i.e., 2025 catch limits), other sources of fishing mortality must be estimated because actual catch information is not yet available. The estimates used to set the 2025 specifications, including the dead discards, are based on data from previous fishing years and represent reasonable estimates (see Comment 1 ).
When calculating catch for previous years, the total number of discards and dead discards are estimated because fishermen and fishery observers cannot record all discards or directly observe all discard mortality. Previous years' discard estimates, and the methods used to calculate them, are based on the best scientific information available (see Comment 2 ).
Final 2022 data for Atlantic spiny dogfish became available in calendar year 2023. In 2024, NMFS identified a difference between the area- and gear-specific discard mortality rates used in Atlantic spiny dogfish catch accounting and the stock assessment. The discard mortality rates used in the Catch Accounting and Monitoring System were updated to those used in the assessment. The updated discard mortality rates were applied to the 2022 catch information available at that time ( i.e., inclusive of any late data), resulting in a higher estimate of 2022 dead discards. This discard estimate, along with actual information on 2023 catch and 2024 catch limits that became available in 2024, was incorporated into the projections that informed the 2025 ABC and catch limits. These updates contributed to the 2025 ABC and quota being lower than those of 2024. This difference is not the result of a payback from the 2025 quota, but 2025 catch limits based on current projections that reflect the best estimates of stock biomass and productivity. These updates ensure the catch limits comply with National Standard 2 requirements to use the best scientific information available and National Standard 1 requirements to prevent overfishing.
Comment 4: Three commenters opposed to the specifications suggested unused 2024 quota should be rolled over to 2025, noting that the 2024 quota was reduced to account for an overage in 2023 and 2024 catch is trending below the 2024 quota.
Response: The Atlantic spiny dogfish fishery is managed under the Atlantic Spiny Dogfish FMP with implementing regulations at § 648 subpart L. The FMP and regulations at § 648.233(c) require a subsequent fishing year ACL be reduced by the amount the ACL is exceeded. The FMP does not authorize the rollover of unused quota in a subsequent fishing year. However, actual catch information is incorporated into stock assessments and projections that inform future catch limits.
Comment 5: One non-governmental organization commented that NMFS should not set the commercial quota any higher than the proposed 9.3 million lb (4,236 mt). The commenter expressed concerns that NMFS endorsed the Mid-Atlantic Council setting the specifications higher than what was originally discussed at its October 2024 meeting and that the Council suspended its risk policy based on industry requests for higher quota. The commenter cautioned against the erosion of precautionary buffers for spiny dogfish, which is a slow-growing species, and disagreed that the specifications include sufficient precaution.
Response: NMFS is implementing a quota at, and not greater than, the proposed 9.3 million lb (4,236 mt). Catch specifications must comply with the Magnuson-Stevens Act National Standards and their guidelines, which include requirements to prevent overfishing and achieve optimum yield (National Standard 1) and to provide for the sustained participation of fishing communities and minimize adverse economic impacts on such communities (National Standard 8). The Councils' decision to consider specifications with a 50-percent probability of overfishing was based on industry testimony that reductions to the commercial quota would create a significant risk to the future of the industry. In 2024, the last remaining southern spiny dogfish processor closed. The industry has raised concerns that the sole remaining processor, which is critical to the viability of the fishery, may close if catch decreases. The Councils further based their recommendations on current stock projections, which indicate the stock is expected to increase to 113 percent of its target under these catch limits. After weighing this information, the Council recommended specifications using the highest ABC allowable under National Standard 1 ( i.e., a 50-percent probability of overfishing; § 600.310(f)(2)(i)) to minimize adverse economic impacts on the industry. NMFS agrees that the Councils' recommended specifications balance the requirements of National Standards 1 and 8.
As described in response to Comment 1, the specifications account for reasonable estimates of other sources of catch. The highest source of uncertainty within the specifications is the discard estimate, as annual discards can vary. To account for uncertainty, the 2025 discard estimate uses the average of two reasonable methods for estimating discards. It represents an increase from the amount set aside for discards in 2024. The Councils agreed, and NMFS concurs, that substantial precaution is taken, and uncertainty accounted for, within these specifications.
Comment 6: One commenter expressed cautious support for the proposed specifications. The commenter noted concerns about the economic impacts that reduced quotas may have on the fishing industry, particularly small businesses, and suggested NMFS monitor the economic impacts on the spiny dogfish industry.
Response: As noted in response to Comment 5, NMFS must comply with the Magnuson-Stevens Act National Standards, including National Standards 1 and 8, when setting catch specifications. Typically, the Mid-Atlantic Council's risk policy requires an ABC based on a 46-percent probability of overfishing for a stock just above its biomass target, such as Atlantic spiny dogfish. The Mid-Atlantic Council voted to waive its risk policy when recommending these specifications due to industry testimony about the potential for negative economic impacts from quota reductions.
The National Standard 8 guidelines specify that the requirement to account for the importance of fishery resources to fishing communities is within the context of the conservation requirements of the Magnuson-Stevens Act (§ 600.345(b)(1)). In other words, the National Standard 8 requirements do not supersede the National Standard 1 requirements to prevent overfishing. An ABC with more than a 50-percent probability of overfishing would risk overfishing, stock depletion, reduced stock productivity, and lower quotas in future years. Sustainable management of the stock, including the prevention of overfishing, is intended to ensure the long-term viability of both the Atlantic spiny dogfish stock and the industry that relies on that stock.
NMFS collects and analyzes economic and social data on the importance of fisheries to communities, as required under National Standard 8 (§ 600.345(c)). In addition, the Regulatory Flexibility Act (RFA) requires NMFS to analyze the impacts of these catch specifications on small business entities. Information on the expected impacts of these catch specifications, including the basis for certification that this action would not have a significant economic impact on a substantial number of small entities, can be found in the proposed rule and in the SIR for this rule. Additional economic analysis of the Atlantic spiny dogfish fishery can be found in the 2024-2026 Atlantic Spiny Dogfish Specifications Environmental Assessment (EA; both the SIR and EA are posted at http://www.mafmc.org/supporting-documents ).
Comment 7: One commenter expressed general support for the specifications and noted the importance of protecting fisheries.
Response: NMFS agrees and is implementing the specifications as recommended by the Mid-Atlantic and New England Councils.
Comment 8: Three members of the commercial fishing industry asserted that the reduced quota would have an economic impact on commercial fishermen and commercial fishing support industries ( e.g., shipping). The commenters state that roughly 100 people in the Commonwealth of Virginia rely on the spiny dogfish fishery, and the fishery makes up the majority of the industry's wintertime work. The commenters state that the reduced quota could potentially cause financial hardship to these individuals, and assert that this contradicts the RFA analysis in the proposed rule for these specifications.
Response: The RFA requires that an agency consider whether an action will have a significant impact on a substantial number of small businesses entities and ways to minimize impacts on small business entities. As provided in the proposed rule, this action would maintain spiny dogfish specifications and commercial quota at a level above recent landings ( i.e., 8.5 million lb (3,855 mt) in 2023, with 2024 catch currently trending lower than that of 2023). As a result, the specifications are expected to have an economic impact similar to recent years. There is no information that the action might impact small businesses differently than large businesses. Further, as discussed throughout this document, these specifications are based on the highest allowable ABC under National Standard 1, and there are no available alternatives that would reduce impacts on small business entities. While the commenters suggest that the reduced quota could potentially have a negative economic impact to the fishery and related businesses, they do not provide evidence that the proposed specifications would be expected to have a significant impact on a substantial number of small businesses nor contest the factual basis for certification under the RFA. No changes were made as a result of these comments.

Classification
NMFS is issuing this rule pursuant to section 305(d) of the Magnuson-Stevens Act (16 U.S.C. 1855(d)). The reason for using this regulatory authority is that in a previous action taken pursuant to section 304(b) of the Magnuson-Stevens Act (16 U.S.C. 1854(b)), the FMP and implementing regulations created the process by which specifications are developed through a NMFS rulemaking process distinct from that of 304(b). See 50 CFR 648.232. As such, NMFS is issuing this rule pursuant to section 305(d). The NMFS Assistant Administrator has determined that this final rule is consistent with the Atlantic Spiny Dogfish FMP and other applicable law.
There is good cause under 5 U.S.C. 553(d)(3) to waive the 30-day delay in effective date. The 2025 fishing year began on May 1, 2025. The Commission adopted a complementary coastwide quota, which went into effect on May 1, 2025. Under the Commission's Interstate Fishery Management Plan for Spiny Dogfish, the coastwide quota is allocated among the relevant states. State management agencies implement annual management measures intended to achieve the state's allocated quota over the fishing year. A delay in the date of effectiveness of the Federal quota substantially beyond May 1 would be contrary to the public interest as it could create misalignment with state management, confusion with state agencies as they prepare their annual management measures, and confusion in the spiny dogfish industry around current quotas. Furthermore, regulated parties do not require any additional time to come into compliance with this rule, and thus, a 30-day delay before the final rule becomes effective does not provide any benefit. Fishery stakeholders have also been involved in the development of this action and are anticipating this rule. For these reasons, there is good cause not to delay this final rule's effectiveness, consistent with 5 U.S.C. 553(d)(3), and to implement this action as soon as possible for the 2025 fishing year.
This final rule is exempt from review under Executive Orders 12866 and 14192.
NMFS has determined that this action would not have a substantial direct effect on one or more Indian Tribes, on the relationship between the Federal Government and Indian Tribes, or on the distribution of power and responsibilities between the Federal Government and Indian Tribes; therefore, consultation with Tribal officials under E.O. 13175 is not required, and the requirements of sections (5)(b) and (5)(c) of E.O. 13175 also do not apply. A Tribal summary impact statement under section (5)(b)(2)(B) and section (5)(c)(2)(B) of E.O. 13175 is not required and has not been prepared.
The Chief Counsel for Regulation of the Department of Commerce certified to the Chief Counsel for Advocacy of the Small Business Administration during the proposed rule stage that this action would not have a significant economic impact on a substantial number of small entities. The factual basis for the certification was published in the proposed rule and is not repeated here. We received one comment regarding the RFA analysis. The comment did not contest the factual basis for the certification. As a result, a regulatory flexibility analysis was not required and none was prepared.
This final rule contains no information collection requirements under the Paperwork Reduction Act of 1995.

Authority:
16 U.S.C. 1801 et seq.
Dated: May 6, 2025.
Samuel D. Rauch III,

Deputy Assistant Administrator for Regulatory Programs, National Marine Fisheries Service.
90
90
Monday, May 12, 2025
Proposed Rules
FEDERAL RETIREMENT THRIFT INVESTMENT BOARD
5 CFR Part 1655
Curing Missed Loan Payments

AGENCY:
Federal Retirement Thrift Investment Board.

ACTION:
Proposed rule.

SUMMARY:
The Federal Retirement Thrift Investment Board (FRTIB) proposes to update its regulations regarding the methods available to participants to cure missed loan payments. The proposed change will also clarify the number of missed payments which must be brought back into compliance by the last day of the quarter following the quarter in which the payment was missed to avoid triggering a deemed distribution.

DATES:
Comments must be received on or before July 11, 2025.

ADDRESSES:
You may submit comments using one of the following methods:
• Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments.
• Mail: Office of General Counsel, Attn: Dharmesh Vashee, Federal Retirement Thrift Investment Board, 77 K Street NE, Suite 1000, Washington, DC 20002.
Comments will be made available to the public online at https://www.regulations.gov. Do not include any personally identifiable or confidential information that you do not want publicly disclosed. Anonymous comments are acceptable.

FOR FURTHER INFORMATION CONTACT:
For press inquiries: James Kaplan at (202) 809-2625. For information about how to comment on this proposed rule: Elizabeth Harris at (202) 913-5300.

SUPPLEMENTARY INFORMATION:
The FRTIB administers the TSP, which was established by the Federal Employees' Retirement System Act of 1986 (FERSA), Public Law 99-335, 100 Stat. 514. The TSP is a retirement savings plan for Federal civilian employees and members of the uniformed services. It is similar to cash or deferred arrangements established for private-sector employees under section 401(k) of the Internal Revenue Code (26 U.S.C. 401(k)). The provisions of FERSA that govern the TSP are codified, as amended, largely at 5 U.S.C. 8351 and 8401-79.
The FRTIB proposes to update its regulations regarding the methods available to participants to cure missed loan payments to include recurring payroll loan deductions. The FRTIB also proposes to clarify the number of missed payments which must be cured to avoid triggering a deemed distribution.
Currently, under FRTIB regulations when a participant misses a loan payment, the participant cannot make up the missed payment through a scheduled payroll deduction. TSP will only accept a one-time payment in the form of a check, guaranteed funds, or direct debit from a personal savings or checking account. The FRTIB proposes to update its regulation to allow participants to use recurring payroll loan deductions to make up missed payments. This proposed change will provide participants with greater flexibility when a loan payment is missed due to a temporary change in payroll status, transfer to another federal agency with a different pay schedule, or other circumstance.
When a participant elects to use a recurring payroll loan deduction to make up a missed payment, the payroll deduction will shift or roll the missed loan payment to the following month. For example, if a participant misses a loan payment in March and restarts payroll loan deductions in April, the April payroll deduction will satisfy the missed March payment. However, the April payment will now be considered missed. When a participant makes up a missed payment through a subsequent month's payroll deduction, the participant will remain behind on their loan repayment schedule by one payment until one of the following occur: a one-time payment is submitted; the maximum loan term is reached, and a deemed distribution occurs; or the participant misses additional payment(s) and a deemed distribution is triggered.
The FRTIB further proposes to amend its regulations regarding the number of missed payments which must be cured to avoid a deemed distribution. IRS regulations provide flexibility to plan sponsors to permit a cure period for missed loan payments that lasts no later than the last day of the calendar quarter following the calendar quarter in which the required installment payment was due. Currently, TSP regulations are more stringent than the IRS requires, and TSP treats a loan as a deemed distribution in instances where a participant has not made up all missed payments by the end of the calendar quarter following the calendar quarter in which the first payment was missed. The FRTIB proposes to align its regulation with the maximum period permitted under IRS regulations to reduce the instances where a participant loan is treated as a deemed distribution in accordance with section 72(p) of the Internal Revenue Code.

Regulatory Flexibility Act
This proposed regulation will not have a significant economic impact on a substantial number of small entities. This regulation will affect Federal employees and members of the uniformed services who participate in the TSP.

Paperwork Reduction Act
This proposed regulation does not require additional reporting under the criteria of the Paperwork Reduction Act.

Unfunded Mandates Reform Act of 1995
Pursuant to the Unfunded Mandates Reform Act of 1995, 2 U.S.C. 602, 632, 653, and 1501-1571, the effects of this regulation on State, local, and tribal governments and the private sector have been assessed. This regulation will not compel the expenditure in any one year of $100 million or more by State, local, and tribal governments, in the aggregate, or by the private sector. Therefore, a statement under 2 U.S.C. 1532 is not required.

List of Subjects in 5 CFR Part 1655
Credit, Government employees, Pensions, Retirement.
Ravindra Deo,

Executive Director, Federal Retirement Thrift Investment Board.
For the reasons stated in the preamble, the FRTIB proposes to amend 5 CFR chapter VI as follows:

PART 1655—LOAN PROGRAM
1. The authority citation for part 1655 continues to read as follows:

Authority:
5 U.S.C. 8432d, 8433(g), 8439(a)(3) and 8474.
2. In § 1655.14 amend by revising paragraph (e) to read as follows:
§ 1655.14
Loan payments.
* * * * *
(e) In the case of a participant who has not separated from Government service, if a payment is not made when due, the TSP record keeper will notify the participant of the missed payment. The participant can make-up the missed payment in the form of a check, guaranteed funds, a one-time payment via loan direct debit from his or her personal savings or checking account, or by resuming scheduled loans payments by payroll deduction. If the participant does not make up the missed payment by the end of the calendar quarter following the calendar quarter in which the payment was missed, the TSP record keeper will declare the loan to be a deemed distribution in accordance with § 1655.15(a). The declaration of a deemed distribution does not relieve the participant of his or her obligation to repay the amount.
* * * * *
DEPARTMENT OF AGRICULTURE
Agricultural Marketing Service
7 CFR Part 205
[Doc. No. AMS-NOP-22-0063]
RIN 0581-AE13
Rescinding National Organic Program; Market Development for Mushrooms and Pet Food

AGENCY:
Agricultural Marketing Service (AMS), Department of Agriculture (USDA).

ACTION:
Notice of proposed rulemaking.

SUMMARY:
AMS is proposing to rescind the rule and regulations issued on December 23, 2024, titled, “National Organic Program; Market Development for Mushrooms and Pet Food.”

DATES:
Comments must be received by June 11, 2025.

ADDRESSES:
Comments may be submitted through the Federal eRulemaking portal at https://www.regulations.gov and should reference the docket number and the date and page number of this issue of the Federal Register . AMS strongly prefers comments to be submitted electronically. However, written comments may be submitted ( i.e., postmarked) via mail to: Erin Healy, Director, Standards Division, National Organic Program, USDA-AMS-NOP, 1400 Independence Ave. SW, Room 2642-So., Ag Stop 0268, Washington, DC 20250-0268.
Instructions: All comments should include the docket number (AMS-NOP-22-0063), and/or the Regulatory Information Number (RIN 0581-AE13) for this rulemaking. You should clearly indicate the topic and section number of this proposed rule to which your comment refers, state your position(s), offer any recommended language change(s), and include relevant information and data to support your position(s) ( e.g., scientific, environmental, manufacturing, industry, or industry impact information, etc.). All comments and relevant background documents posted to https://www.regulations.gov will include any personal information provided.

FOR FURTHER INFORMATION CONTACT:
Erin Healy, Director, Standards Division, National Organic Program, USDA-AMS-NOP, 1400 Independence Ave. SW, Room 2642-So., Ag Stop 0268, Washington, DC 20250-0268; Telephone: 202-720-3252, Email: Erin.Healy@usda.gov.

SUPPLEMENTARY INFORMATION:
AMS is proposing to rescind the rule issued on December 23, 2024, National Organic Program; Market Development for Mushrooms and Pet Food, via 89 FR 104367, amending 7 CFR part 205. The rule proposed for rescission amended the USDA organic regulations to clarify standards for organic mushrooms and organic pet food. AMS proposes to rescind this rule in full and seek comments on all aspects of that proposal.

Procedural Matters

Executive Orders 12866 and 13563
As with the rule (89 FR 104367) proposed for rescission, this rule does not meet the criteria of a “significant regulatory action” under Executive Order 12866, as amended by Executive Orders 14215 and 13563. Therefore, the Office of Management and Budget (OMB) has not reviewed this rule under those orders.
This regulation is not an Executive Order 14192 regulatory action.

Regulatory Flexibility Act
Under the Regulatory Flexibility Act (RFA) (5 U.S.C. 601-612) (as amended by the Small Business Regulatory Enforcement Fairness Act (SBREFA) of 1996, 5 U.S.C. 601 et seq. ), agencies must prepare and make available for public comment a regulatory flexibility analysis that describes the effect of the rule on small entities ( i.e., small businesses, small organizations, and small government jurisdictions). In the final rule (89 FR 104367), AMS concluded and certified that the rule would not have a significant economic impact on a substantial number of small entities and therefore did not conduct a regulatory flexibility analysis. Similarly, this proposed recission rule will only have minor impacts on small entities engaged in organic mushroom operations and pet food producers. This proposed recission of the rule is expected to have a beneficial effect on these small entities, lowering costs related to paperwork burden and otherwise allowing operators and producers to continue to engage in beneficial and often industry-standard practices without additional regulatory costs. The same is true for certifying agents that certify organic mushroom or pet food operations.

Unfunded Mandates Reform Act
This proposed rule does not contain Federal mandates (under the regulatory provisions of title II of the UMRA) for State, local and Tribal governments, or the private sector of $100 million or more in any one year. Thus, the rule is not subject to the requirements of sections 202 and 205 of the UMRA.

Executive Order 13175
Executive Order 13175 requires Federal agencies to consult and coordinate with Tribes on a government-to-government basis on policies that have Tribal implications, including regulations, legislative comments or proposed legislation, and other policy statements or actions that have substantial direct effects on one or more Indian Tribes, on the relationship between the Federal Government and Indian Tribes, or on the distribution of power and responsibilities between the Federal Government and Indian Tribes. AMS has assessed the impact of this proposed rule on Indian Tribes and determined that this rule would not have Tribal implications that require consultation under Executive Order 13175.

Paperwork Reduction Act
In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. 3501- 3520), an agency may not conduct or sponsor, and a person is not required to respond to, a collection of information, unless the collection displays a currently valid Office of Management and Budget (OMB) control number. This proposed rule is deregulatory and so would not impose any additional information collection requirements; rather, it would reduce future collection requirements by removing reporting burdens.

E-Government Act Compliance
The Department is committed to complying with the E-Government Act, 2002 to promote the use of the internet and other information technologies to provide increased opportunities for citizen access to Government information and services, and for other purposes.

Executive Order 13132; Federalism Summary Impact Statement
The proposed rule is deregulatory and has little effect on States and local governments, so AMS anticipates that this rule will not have implications for federalism. Therefore, under section 6(b) of the Executive Order, a federalism summary is not required. States and local governments are invited to comment if they believe a federalism summary is necessary.

NEPA
AMS believes this proposed rule, if finalized, would not have a reasonably foreseeable significant effect on the quality of the human environment. AMS invites the public to comment on the impact of the proposed agency action.

List of Subjects in 7 CFR Part 205
Administrative practice and procedure, Agricultural commodities, Agriculture, Animals, Archives and records, Fees, Imports, Labeling, Livestock, Organically produced products, Plants, Reporting and recordkeeping requirements, Seals and insignia, Soil conservation.
For the reasons set forth above, AMS proposes to amend 7 CFR part 205 as follows:

PART 205—NATIONAL ORGANIC PROGRAM
1. The authority citation for 7 CFR part 205 continues to read as follows:

Authority:
7 U.S.C. 6501-6524.
2. Amend § 205.2 by:
a. Revising the definitions of “Compost” and “Crop”;
b. Removing the definitions for “Mushroom”, “Mushroom mycelium”, “Mushroom spawn”, “Mushroom spawn media”, “Mushroom substrate”, “Pet”, and “Pet food”; and
c. Revising the definition of “Wild crop”.
The revisions read as follows:
§ 205.2
Terms defined.
* * * * *
Compost. The product of a managed process through which microorganisms break down plant and animal materials into more available forms suitable for application to the soil. Compost must be produced through a process that combines plant and animal materials with an initial C:N ratio of between 25:1 and 40:1. Producers using an in-vessel or static aerated pile system must maintain the composting materials at a temperature between 131 °F and 170 °F for 3 days. Producers using a window system must maintain the composting materials at a temperature between 131 °F and 170 °F for 15 days, during which time, the materials must be turned a minimum of five times.
* * * * *
Crop. Pastures, cover crops, green manure crops, catch crops, or any plant or part of a plant intended to be marketed as an agricultural product, fed to livestock, or used in the field to manage nutrients and soil fertility.
* * * * *
Wild crop. Any plant or portion of a plant that is collected or harvested from a site that is not maintained under cultivation or other agricultural management.
* * * * *
§ 205.210
[Removed and Reserved]
3. Remove and reserve § 205.210.
§ 205.270
[Amended]
4. Amend § 205.270 by removing and reserving paragraph (d).
5. Amend § 205.601 by revising paragraphs (i) introductory text and (j) introductory text to read as follows:
§ 205.601
Synthetic substances allowed for use in organic crop production.
* * * * *
(i) As plant disease control.
* * * * *
(j) As plant or soil amendments.
* * * * *
§ 205.605
[Amended]
6. Amend § 205.605 by removing paragraph (b)(36) and redesignating paragraphs (b)(37) and (38) as paragraphs (b)(36) and (37), respectively.
Bruce Summers,

Administrator, Agricultural Marketing Service.
SMALL BUSINESS ADMINISTRATION
13 CFR Parts 124 and 125
Tribal Consultation for 8(a) Business Development Program and Mentor-Protégé Program Issues and Best Practices

AGENCY:
U.S. Small Business Administration.

ACTION:
Notice of tribal consultation meeting.

SUMMARY:
The U.S. Small Business Administration (SBA) announces that it is holding a tribal consultation meeting in Anchorage, Alaska requesting comments and input on a variety of topics relating to the 8(a) program and the mentor-protégé program. SBA is requesting general comments and input on how the 8(a) program is working and is inviting suggestions on potential avenues for making the program more efficient or reducing the regulatory burden on participants in the program. Additionally, SBA requests comments and input on best practices for how entity-owned firms market their capabilities to procuring agencies. SBA is also requesting comments and input on how to ensure the mentor-protégé program is operating as intended.

DATES:
The Tribal Consultation meeting date is Friday, June 13, 2025, 9:30 a.m. to 12 p.m. (AKDT), Anchorage, Alaska. The Tribal Consultation meeting pre-registration deadline date is June 6, 2025.

ADDRESSES:
1. The Tribal Consultation meeting will be held at Z.J. Loussac Public Library, 3600 Denali Street, Anchorage, AK 99503.
2. Send pre-registration requests to attend and/or testify to Diane Cullo, Assistant Administrator, Office of Native American Affairs, U.S. Small Business Administration, 409 3rd Street SW, Washington, DC 20416; Diane.Cullo@sba.gov; or Facsimile to (202) 481-2177.
3. You may submit written comments to SBA by sending them to Diane Cullo, Assistant Administrator, Office of Native American Affairs, U.S. Small Business Administration, 409 3rd Street SW, Washington, DC 20416; or Diane.Cullo@sba.gov; or Facsimile to (202) 481-2177. If you wish to submit confidential business information (CBI), please submit the information to Diane Cullo, Assistant Administrator, Office of Native American Affairs, U.S. Small Business Administration, 409 3rd Street SW, Washington, DC 20416 and highlight the information that you consider to be CBI and explain why you believe this information should be held confidential. SBA will review the information and make a final determination of whether the information will be published or not.

FOR FURTHER INFORMATION CONTACT:
Diane Cullo, Assistant Administrator, Office of Native American Affairs, at Diane.cullo@sba.gov or (202) 619-0518 or by facsimile to (202) 481-2177.

SUPPLEMENTARY INFORMATION:

I. Background
SBA is seeking input from the Native American community on the general management and operation of the 8(a) and mentor protégé programs (particularly with respect to 8(a) firms owned by tribes, Alaska Native Corporations (ANCs), and Native Hawaiian Organizations (NHOs)) as part of the Administration's desire to make these programs more effective and improve the delivery of them to the small business community. Accordingly, SBA is interested in receiving comments from representatives of tribes, ANCs and NHOs offering their perspective on how the 8(a) program is working generally and providing suggestions for how the program could be made more efficient to better suit the needs of small businesses owned by these entities. Additionally, SBA is asking for input on best practices on how entity-owned firms market their capabilities to procuring agencies. SBA has found that certain practices may be negatively impacting entity-owned firms' ability to receive awards. For example, contracting officers may consider entity-owned firms to be affiliated with each other when several appear on the same web page or where multiple firms owned by the same entity have the exact same capabilities and contact points. SBA is seeking comments and input from firms who have encountered these or similar issues and how they have been able to successfully market their sophisticated capabilities while still making clear to procuring agencies that they are independent small businesses. Lastly, SBA wishes to discuss and is inviting comments on the mentor-protégé program. In particular, SBA is interested in receiving comments and input on whether protégé firms can truly direct and manage mentor firms when performing a joint venture mentor-protégé joint venture project. It has come to SBA's attention that some mentors that have pre-existing relationships with certain procuring agencies do not include protégé firms in critical meetings with those agencies, despite the protege being the project manager of the joint venture. SBA believes that this is contrary to the intent of the mentor-protégé program. Protégé firms should be the ones directing the actions of a mentor-protégé joint venture, not the mentor. SBA is concerned that this may also lead to instances of non-compliance with the limitations on subcontracting requirements. SBA seeks comments and guidance on this issue.

Tribal Consultation Meeting
The purpose of this tribal consultation meeting is to conform to the requirements of Executive Order 13175, Tribal Consultations; to provide interested parties with an opportunity to discuss their views on the issues; and for SBA to obtain the views of SBA's stakeholders on ways to maximize efficiency and reduce the burden on small businesses in the 8(a) BD program and mentor-protégé program regulations. SBA considers tribal consultation meetings a valuable component of its deliberations and believes that this tribal consultation meeting will allow for constructive dialogue with the Tribal community, Tribal Leaders, Tribal Elders, elected members of Alaska Native Villages or their appointed representatives, and principals of tribally-owned and ANC-owned firms participating in the 8(a) BD and mentor-protégé programs.
The format of this tribal consultation meeting will consist of a panel of SBA representatives who will preside over the session. The oral and written testimony as well as any comments SBA receives will become part of the administrative record for SBA's consideration. Written testimony may be submitted in lieu of oral testimony. SBA will analyze the testimony, both oral and written, along with any written comments received. SBA officials may ask questions of a presenter to clarify or further explain the testimony. The purpose of the tribal consultation is to assist SBA with gathering information to guide SBA's review process and to potentially develop new proposals. SBA requests that the comments focus on issues as they pertain to the 8(a) BD and mentor-protégé regulations, input related to what changes could be made to make these programs more attractive to procuring agencies and small businesses, or the unique concerns of the Tribal and Native communities. SBA requests that commenters do not raise issues pertaining to other SBA small business programs. Presenters are encouraged to provide a written copy of their testimony. SBA will accept written material that the presenter wishes to provide that further supplements his or her testimony. Electronic or digitized copies are encouraged.
The tribal consultation meeting will be held for one day. The meeting will begin at 9:30 a.m. and end at 12 p.m. (AKDT). SBA will adjourn early if all those scheduled have delivered their testimony.

II. Registration
SBA respectfully requests that any elected or appointed representative of the tribal communities or principal of a tribally-owned, ANC-owned or NHO-owned 8(a) firm that is interested in attending please pre-register in advance and indicate whether you would like to testify at the hearing. Registration requests should be received by SBA by June 6, 2025. Please contact Diane Cullo, Assistant Administrator, Office of Native American Affairs in writing at Diane.Cullo@sba.gov or by facsimile to (202) 481-2950. If you are interested in testifying please include the following information relating to the person testifying: Name, Organization affiliation, Address, Telephone number, Email address and Fax number. SBA will attempt to accommodate all interested parties that wish to present testimony. Based on the number of registrants it may be necessary to impose time limits to ensure that everyone who wishes to testify has the opportunity to do so. SBA will confirm in writing the registration of presenters and attendees.

Authority:
15 U.S.C. 634 and E.O. 13175, 65 FR 67249.
Dated: May 7, 2025.
Diane Cullo,

Assistant Administrator, Office of Native American Affairs.
DEPARTMENT OF TRANSPORTATION
Federal Aviation Administration
14 CFR Part 71
[Docket No. FAA-2025-0668; Airspace Docket No. 24-ASO-34]
RIN 2120-AA66
Establishment of United States Area Navigation (RNAV) Routes Q-190 and T-497, and Amendment of Domestic Very High Frequency Omnidirectional Range (VOR) Federal Airways V-1, V-70, and V-194; Eastern United States

AGENCY:
Federal Aviation Administration (FAA), DOT.

ACTION:
Notice of proposed rulemaking (NPRM).

SUMMARY:
This action proposes to establish United States Area Navigation (RNAV) Routes Q-190 and T-497, and amend domestic Very High Frequency Omnidirectional Range (VOR) Federal Airways V-1, V-70, and V-194 in the eastern United States. The FAA is taking this action due to the planned decommissioning of the Cofield, NC (CVI), VOR/Tactical Air Navigation (VORTAC). This action is in support of the FAA's VOR Minimum Operational Network (MON) Program.

DATES:
Comments must be received on or before June 26, 2025.

ADDRESSES:
Send comments identified by FAA Docket No. FAA-2025-0668 and Airspace Docket No. 24-ASO-34 using any of the following methods:
* Federal eRulemaking Portal: Go to www.regulations.gov and follow the online instructions for sending your comments electronically.
* Mail: Send comments to Docket Operations, M-30; U.S. Department of Transportation, 1200 New Jersey Avenue SE, Room W12-140, West Building Ground Floor, Washington, DC 20590-0001.
* Hand Delivery or Courier: Take comments to Docket Operations in Room W12-140 of the West Building Ground Floor at 1200 New Jersey Avenue SE, Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays.
* Fax: Fax comments to Docket Operations at (202) 493-2251.
Docket: Background documents or comments received may be read at www.regulations.gov at any time. Follow the online instructions for accessing the docket or go to the Docket Operations in Room W12-140 of the West Building Ground Floor at 1200 New Jersey Avenue SE, Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays.
FAA Order JO 7400.11J, Airspace Designations and Reporting Points, and subsequent amendments can be viewed online at www.faa.gov/air_traffic/publications/. You may also contact the Rules and Regulations Group, Policy Directorate, Federal Aviation Administration, 600 Independence Avenue SW, Washington, DC 20597; telephone: (202) 267-8783.

FOR FURTHER INFORMATION CONTACT:
Brian Vidis, Rules and Regulations Group, Policy Directorate, Federal Aviation Administration, 600 Independence Avenue SW, Washington, DC 20597; telephone: (202) 267-8783.

SUPPLEMENTARY INFORMATION:

Authority for This Rulemaking
The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle I, Section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of the airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it amends the route structure to maintain the efficient flow of air traffic within the National Airspace System (NAS).

Comments Invited
The FAA invites interested persons to participate in this rulemaking by submitting written comments, data, or views. Comments are specifically invited on the overall regulatory, aeronautical, economic, environmental, and energy-related aspects of the proposal. The most helpful comments reference a specific portion of the proposal, explain the reason for any recommended change, and include supporting data. To ensure the docket does not contain duplicate comments, commenters should submit only one time if comments are filed electronically, or commenters should send only one copy of written comments if comments are filed in writing.
The FAA will file in the docket all comments it receives, as well as a report summarizing each substantive public contact with FAA personnel concerning this proposed rulemaking. Before acting on this proposal, the FAA will consider all comments it receives on or before the closing date for comments. The FAA will consider comments filed after the comment period has closed if it is possible to do so without incurring expense or delay. The FAA may change this proposal in light of the comments it receives.
Privacy: In accordance with 5 U.S.C. 553(c), DOT solicits comments from the public to better inform its rulemaking process. DOT posts these comments, without edit, including any personal information the commenter provides, to www.regulations.gov, as described in the system of records notice (DOT/ALL-14 FDMS), which can be reviewed at www.dot.gov/privacy.

Availability of Rulemaking Documents
An electronic copy of this document may be downloaded through the internet at www.regulations.gov. Recently published rulemaking documents can also be accessed through the FAA's web page at www.faa.gov/air_traffic/publications/airspace_amendments/.
You may review the public docket containing the proposal, any comments received and any final disposition in person in the Dockets Operations office (see ADDRESSES section for address, phone number, and hours of operations). An informal docket may also be examined during normal business hours at the office of the Eastern Service Center, Federal Aviation Administration, Room 210, 1701 Columbia Avenue, College Park, GA 30337.

Incorporation by Reference
United States Area Navigation Routes are published in paragraphs 2006 and 6011, and Domestic VOR Federal Airways are published in paragraph 6010(a) of FAA Order JO 7400.11, Airspace Designations and Reporting Points, which is incorporated by reference in 14 CFR 71.1 on an annual basis. This document proposes to amend the current version of that order, FAA Order JO 7400.11J, dated July 31, 2024, and effective September 15, 2024. These updates would be published in the next update to FAA Order JO 7400.11. FAA Order JO 7400.11J is publicly available as listed in the ADDRESSES section of this document. FAA Order JO 7400.11J lists Class A, B, C, D, and E airspace areas, air traffic service routes, and reporting points.

Background
The FAA is planning to decommission the Cofield, NC (CVI), VORTAC in March 2026. The Cofield VORTAC was a candidate navigational aid (NAVAID) identified for discontinuance by the FAA's VOR MON program and listed in the Final policy statement notice, “Provision of Navigation Services for the Next Generation Air Transportation System (NextGen) Transition to Performance-Based Navigation (PBN) (Plan for Establishing a VOR Minimum Operational Network),” published in the Federal Register on July 26, 2016 (81 FR 48694), Docket No. FAA-2011-1082.
The Air Traffic Service (ATS) routes affected by the planned NAVAID decommissioning are VOR Federal Airways V-1, V-70, and V-194. With the planned decommissioning of the Cofield VORTAC, the remaining ground-based NAVAID coverage in the area is insufficient to enable the continuity of the affected ATS routes. As such, proposed modifications to VOR Federal Airways V-1, V-70, and V-194 would result in the airways being shortened.
To overcome the proposed modifications to the affected routes, instrument flight rules (IFR) traffic could use adjacent VOR Federal Airways V-139, V-157, V-266, V-310, and V-472 or receive air traffic control (ATC) radar vectors to fly through or circumnavigate the affected area. Additionally, IFR pilots with Area Navigation (RNAV)-equipped aircraft could also use the adjacent RNAV Routes T-291, T-303, T-307, T-480, and T-497; or navigate point-to-point using the existing fixes that will remain in place to support continued operations through the affected area. Visual flight rules (VFR) pilots who elect to navigate via airways through the affected area could also take advantage of ATC services listed previously.

The Proposal
The FAA is proposing an amendment to 14 CFR part 71 to establish RNAV Routes Q-190 and T-497, and amend domestic VOR Federal Airways V-1, V-70, and V-194 to support the planned decommissioning of the Cofield, NC (CVI), VORTAC. This action is in support of the FAA's VOR MON Program.
Q-190: Q-190 is a new RNAV route proposed to extend between the Carleton, MI (CRL), VOR/Distance Measuring Equipment (VOR/DME) and the PONCT, NY, waypoint (WP). The route would overlay Jet Route J-190 between the Carleton VOR/DME and the PONCT WP. The new proposed route would provide RNAV connectivity between the Detroit, MI area and the Albany, NY area.
V-1: V-1 currently extends between the Craig, FL (CRG), VORTAC and the Boston, MA (BOS), VOR/DME. The FAA proposes to remove the airway segments between the Kinston, NC (ISO), VORTAC and the Cape Charles, VA (CCV), VORTAC due to the scheduled decommissioning of the Cofield, NC (CVI), VORTAC. As amended, the airway would be changed to extend between the Craig VORTAC and the Kinston VORTAC; and between the Cape Charles VORTAC and the Boston VOR/DME. Concurrent changes to other segments of V-1 have been proposed in a separate rulemaking docket, Docket No. FAA 2024-2512 published in the Federal Register (89 FR 93233; November 26, 2024).
V-70: V-70 currently extends between Monterrey Mexico and the Picayune, MS (PCU), VOR/DME; between the Monroeville, AL (MVC), VORTAC and the Allendale, SC (ALD), VOR; and between the Grand Strand, SC (CRE), VORTAC and the Cofield, NC (CVI), VORTAC. The airspace within Mexico is excluded. The FAA proposes to remove the airway segments between the Kinston, NC (ISO), VORTAC and the Cofield VORTAC due to the scheduled decommissioning of the Cofield VORTAC. As amended, the airway would be changed to extend between Monterrey Mexico and the Picayune VOR/DME; between the Monroeville VORTAC and the Allendale VOR; and between the Grand Strand VORTAC and the Kinston VORTAC. The airspace within Mexico would remain excluded.
V-194: V-194 currently extends between the Cedar Creek, TX (CQY), VORTAC and the College Station, TX (CLL), VORTAC; between the Sabine Pass, TX (SBI), VOR/DME and the Meridian, MS (MEI), VORTAC; and between the Liberty, NC (LIB), VORTAC and the intersection of the Cofield, NC (CVI), VORTAC 077° and the Norfolk, VA (ORF), VORTAC 209° radials (SUNNS Fix). The FAA proposes to remove the airway segments between the Tar River, NC (NC), VORTAC and the SUNNS Fix due to the scheduled decommissioning of the Cofield VORTAC. As amended, the airway would be changed to extend between the Cedar Creek VORTAC and the College Station VORTAC; between the Sabine Pass VOR/DME and the Meridian VORTAC; and between the Liberty VORTAC and the Tar River VORTAC.
T-497: T-497 is a proposed new RNAV route that would extend between the Elizabeth City, NC (ECG), VOR/DME and the FAGED, VA, WP. The route would overlay VOR Federal Airway V-286 between the OUTLA, VA, WP and the FAGED, VA, Fix. The new proposed route would provide RNAV connectivity between the Elizabeth City, NC area and the Warsaw, VA area.
The full proposed descriptions of the above routes are set forth below in the proposed text amendments to part 71. The NAVAID radials listed in the VOR Federal airway description regulatory text of this NPRM are stated in degrees True north. Additionally, minor editorial corrections to the airway descriptions are made to comply with ATS route formatting requirements.

Regulatory Notices and Analyses
The FAA has determined that this proposed regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. It, therefore: (1) is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. Since this is a routine matter that will only affect air traffic procedures and air navigation, it is certified that this proposed rule, when promulgated, will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

Environmental Review
This proposal will be subject to an environmental analysis in accordance with FAA Order 1050.1F, “Environmental Impacts: Policies and Procedures” prior to any FAA final regulatory action.

List of Subjects in 14 CFR Part 71
Airspace, Incorporation by reference, Navigation (air).

The Proposed Amendment
In consideration of the foregoing, the Federal Aviation Administration proposes to amend 14 CFR part 71 as follows:

PART 71—DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR TRAFFIC SERVICE ROUTES; AND REPORTING POINTS
1. The authority citation for 14 CFR part 71 continues to read as follows:

Authority:
49 U.S.C. 106(f), 106(g), 40103, 40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.
§ 71.1
[Amended]
2. The incorporation by reference in 14 CFR 71.1 of FAA Order JO 7400.11J, Airspace Designations and Reporting Points, dated July 31, 2024, and effective September 15, 2024, is amended as follows:

Paragraph 2006 United States Area Navigation Routes.
* * * * *
Q-190 Carleton, MI (CRL) to PONCT, NY [New]
Carleton, MI (CRL) | VOR/DME | (Lat. 42°02′52.90″ N, long. 083°27′27.26″ W)
WIGGZ, PA | WP | (Lat. 41°30′51.00″ N, long. 077°58′52.00″ W)
RAHKS, NY | WP | (Lat. 42°27′59.28″ N, long. 075°14′21.68″ W)
PONCT, NY | WP | (Lat. 42°44′48.83″ N, long. 073°48′48.07″ W)
* * * * *

Paragraph 6010(a) Domestic VOR Federal Airways.
* * * * *

V-1 [Amended]
From Craig, FL, INT Craig 020° and Charleston, SC, 214° radials; Charleston; Grand Strand, SC; INT Grand Strand 031° and Kinston, NC, 214° radials; to Kinston. From Cape Charles, VA; INT Cape Charles 006° and Salisbury, MD, 206° radials; Salisbury; Waterloo, DE; INT Waterloo 024° and Coyle, NJ, 216° radials; Coyle; INT Coyle 036° and Kennedy, NY, 209° radials; Kennedy; Deer Park, NY; Madison, CT; Hartford, CT; INT Hartford 040° and Boston, MA, 252° radials; to Boston, MA; excluding the airspace below 2,700 feet MSL outside the United States between STARY INT and Charleston, SC. The portions within R-5002A, R-5002C and R-5002D are excluded during their times of use. The airspace within R-4006 is excluded.
* * * * *

V-70 [Amended]
From Monterrey, Mexico; Brownsville, TX; INT Brownsville 338° and Corpus Christi, TX, 193° radials; 34 miles standard width, 37 miles 7 miles wide (4 miles E and 3 miles W of centerline), Corpus Christi; INT Corpus Christi 054° and Palacios, TX, 226° radials; Palacios; Scholes, TX; Sabine Pass, TX; Lake Charles, LA; Lafayette, LA; Fighting Tiger, LA; to Picayune, MS. From Monroeville, AL; INT Monroeville 073° and Eufaula, AL, 258° radials; Eufaula; Vienna, GA; to Allendale, SC. From Grand Strand, SC; Wilmington, NC; to Kinston, NC. The airspace within Mexico is excluded.
* * * * *

V-194 [Amended]
From Cedar Creek, TX; to College Station, TX. From Sabine Pass, TX; Lafayette, LA; Fighting Tiger, LA; McComb, MS; INT McComb 055° and Meridian, MS, 221° radials; to Meridian. From Liberty, NC; Raleigh-Durham, NC; to Tar River, NC.
* * * * *

Paragraph 6011 United States Area Navigation Routes.
* * * * *
T-497 Elizabeth City, NC (ECG) to FAGED, VA [New]
Elizabeth City, NC (ECG) | VOR/DME | (Lat. 38°20′16.21″ N, long. 076°26′10.51″ W)
Oceana, VA (NTU) | TACAN | (Lat. 38°05′59.23″ N, long. 076°39′50.85″ W)
SKOUT, VA | FIX | (Lat. 37°51′07.69″ N, long. 076°40′55.91″ W)
TURET, VA | FIX | (Lat. 37°20′45.48″ N, long. 075°59′54.08″ W)
FAAFO, VA | WP | (Lat. 37°20′13.20″ N, long. 075°55′30.29″ W)
BAYSO, VA | WP | (Lat. 37°19′17.65″ N, long. 075°49′40.37″ W)
LNSKY, VA | FIX | (Lat. 37°03′08.52″ N, long. 075°44′12.51″ W)
OUTLA, VA | WP | (Lat. 37°00′10.90″ N, long. 075°47′08.35″ W)
FAGED, VA | FIX | (Lat. 36°55′55.13″ N, long. 075°51′07.39″ W)
* * * * *
Issued in Washington, DC, on May 6, 2025.
Brian Konie,

Manager (A), Rules and Regulations Group.
DEPARTMENT OF TRANSPORTATION
Federal Aviation Administration
14 CFR Part 71
[Docket No. FAA-2025-0099; Airspace Docket No. 24-ANM-124]
RIN 2120-AA66
Establishment of Class E Airspace; Ekalaka Airport, Ekalaka, MT

AGENCY:
Federal Aviation Administration (FAA), DOT.

ACTION:
Notice of proposed rulemaking (NPRM).

SUMMARY:
This action proposes to establish Class E airspace extending upward from 700 feet above the surface at Ekalaka Airport, Ekalaka, MT. This action would support the airport's transition from visual flight rules (VFR) to instrument flight rules (IFR) operations.

DATES:
Comments must be received on or before June 26, 2025.

ADDRESSES:
Send comments identified by FAA Docket No. FAA-2025-0099 and Airspace Docket No. 24-ANM-124 using any of the following methods:
* Federal eRulemaking Portal: Go to www.regulations.gov and follow the online instructions for sending your comments electronically.
* Mail: Send comments to Docket Operations, M-30; U.S. Department of Transportation, 1200 New Jersey Avenue SE, Room W12-140, West Building Ground Floor, Washington, DC 20590-0001.
* Hand Delivery or Courier: Take comments to Docket Operations in Room W12-140 of the West Building Ground Floor at 1200 New Jersey Avenue SE, Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays.
* Fax: Fax comments to Docket Operations at (202) 493-2251.
Docket: Background documents or comments received may be read at www.regulations.gov at any time. Follow the online instructions for accessing the docket or go to the Docket Operations in Room W12-140 of the West Building Ground Floor at 1200 New Jersey Avenue SE, Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays.
FAA Order JO 7400.11J, Airspace Designations and Reporting Points, and subsequent amendments can be viewed online at www.faa.gov/air_traffic/publications/. You may also contact the Rules and Regulations Group, Office of Policy, Federal Aviation Administration, 800 Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-8783.

FOR FURTHER INFORMATION CONTACT:
Jeffrey Drasin, Federal Aviation Administration, Western Service Center, Operations Support Group, 2200 S 216th Street, Des Moines, WA 98198; telephone (206) 231-2248.

SUPPLEMENTARY INFORMATION:

Authority for This Rulemaking
The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle I, Section 106, describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of the airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority, as it would establish Class E airspace extending upward from 700 feet above the surface to support IFR operations at Ekalaka Airport, Ekalaka, MT.

Comments Invited
The FAA invites interested persons to participate in this rulemaking by submitting written comments, data, or views. Comments are specifically invited on the overall regulatory, aeronautical, economic, environmental, and energy-related aspects of the proposal. The most helpful comments reference a specific portion of the proposal, explain the reason for any recommended change, and include supporting data. To ensure the docket does not contain duplicate comments, commenters should submit only one time if comments are filed electronically, or commenters should send only one copy of written comments if comments are filed in writing.
The FAA will file in the docket all comments it receives, as well as a report summarizing each substantive public contact with FAA personnel concerning this proposed rulemaking. Before acting on this proposal, the FAA will consider all comments it receives on or before the closing date for comments. The FAA will consider comments filed after the comment period has closed if it is possible to do so without incurring expense or delay. The FAA may change this proposal in light of the comments it receives.
Privacy: In accordance with 5 U.S.C. 553(c), DOT solicits comments from the public to better inform its rulemaking process. DOT posts these comments, without edit, including any personal information the commenter provides, to www.regulations.gov, as described in the system of records notice (DOT/ALL-14 FDMS), which can be reviewed at www.dot.gov/privacy.

Availability of Rulemaking Documents
An electronic copy of this document may be downloaded through the internet at www.regulations.gov. Recently published rulemaking documents can also be accessed through the FAA's web page at www.faa.gov/air_traffic/publications/airspace_amendments/.
You may review the public docket containing the proposal, any comments received and any final disposition in person in the Dockets Operations office (see ADDRESSES section for address, phone number, and hours of operations). An informal docket may also be examined during normal business hours at the office at the Northwest Mountain Regional Office of the Federal Aviation Administration, Air Traffic Organization, Western Service Center, Operations Support Group, 2200 S 216th Street, Des Moines, WA 98198.

Incorporation by Reference
Class E5 airspace designations are published in paragraph 6005 of FAA Order JO 7400.11, Airspace Designations and Reporting Points, which is incorporated by reference in 14 CFR 71.1 on an annual basis. This document proposes to amend the current version of that order, FAA Order JO 7400.11J, dated July 31, 2024 and effective September 15, 2024. These updates would be published in the next update to FAA Order JO 7400.11. FAA Order JO 7400.11J, is publicly available as listed in the ADDRESSES section of this document.
FAA Order JO 7400.11J lists Class A, B, C, D, and E airspace areas, air traffic service routes, and reporting points.

The Proposal
The FAA is proposing an amendment to 14 CFR part 71 to establish Class E airspace extending upward from 700 feet above the surface at Ekalaka Airport, Ekalaka, MT.
As proposed, Class E airspace would be established extending upward from 700 feet within a 3-mile radius of the airport with extensions to the southeast and northwest. The configuration would provide sufficient containment to the southeast for arriving IFR operations on the Global Positioning System (GPS) Runway (RWY) 31 approach below 1,500 feet above the surface and departing IFR operations on the RWY 13 obstacle departure procedure (ODP) until reaching 1,200 feet above the surface. Additional containment would be added to the northwest to accommodate arriving IFR operations on the GPS RWY 13 approach below 1,500 feet above the surface and departing IFR operations on the RWY 31 ODP until reaching 1,200 feet above the surface.

Regulatory Notices and Analyses
The FAA has determined that this proposed regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. It, therefore: (1) is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. Since this is a routine matter that will only affect air traffic procedures and air navigation, it is certified that this proposed rule, when promulgated, will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

Environmental Review
This proposal will be subject to an environmental analysis in accordance with FAA Order 1050.1F, “Environmental Impacts: Policies and Procedures,” prior to any FAA final regulatory action.

List of Subjects in 14 CFR Part 71
Airspace, Incorporation by reference, Navigation (air).

The Proposed Amendment
In consideration of the foregoing, the Federal Aviation Administration proposes to amend 14 CFR part 71 as follows:

PART 71—DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR TRAFFIC SERVICE ROUTES; AND REPORTING POINTS
1. The authority citation for 14 CFR part 71 continues to read as follows:

Authority:
49 U.S.C. 106(f), 106(g), 40103, 40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.
§ 71.1
[Amended]
2. The incorporation by reference in 14 CFR 71.1 of FAA Order JO 7400.11J, Airspace Designations and Reporting Points, dated July 31, 2024, and effective September 15, 2024, is amended as follows:

Paragraph 6005 Class E Airspace Areas Extending Upward From 700 Feet or More Above the Surface of the Earth.
* * * * *

ANM MT E5 Ekalaka, MT [New]
Ekalaka Airport, MT
(Lat. 45°52′35″ N, long, 104°32′15″ W)
That airspace extending upward from 700 feet above the surface within a 3-mile radius of the airport and within 2.1 miles on either side of the airport's 138° bearing extending from the 3-mile radius to 6.5 miles southeast, and within 2.1 miles on either side of the airport's 318° bearing extending from the 3-mile radius to 8.5 miles northwest.
* * * * *
Issued in Des Moines, Washington, on May 6, 2025.
B.G. Chew,

Group Manager, Operations Support Group, Western Service Center.
DEPARTMENT OF HOMELAND SECURITY
Coast Guard
33 CFR Part 100
[Docket Number USCG-2025-0130]
RIN 1625-AA08
Special Local Regulation; Allegheny River Mile Marker 20.5-21.5, Creighton, PA

AGENCY:
Coast Guard, Department of Homeland Security (DHS).

ACTION:
Notice of proposed rulemaking.

SUMMARY:
The Coast Guard is proposing to establish a temporary special local regulation on the waters of the Allegheny River from mile marker 20.5 to mile marker 21.5 in Creighton, PA. This action is necessary to provide for the safety of life on these navigable waters from potential hazards during the powerboat regatta for the activities planned from June 7, 2025, through June 8, 2025. This proposed rulemaking would prohibit persons and vessels from being in the regulated area unless authorized by the Captain of the Port Pittsburgh or a designated representative. We invite your comments on this proposed rulemaking.

DATES:
Comments and related material must be received by the Coast Guard on or before May 27, 2025.

ADDRESSES:
You may submit comments identified by docket number USCG-2025-0130 using the Federal Decision-Making Portal at https://www.regulations.gov. See the “Public Participation and Request for Comments” portion of the SUPPLEMENTARY INFORMATION section for further instructions on submitting comments. This notice of proposed rulemaking with its plain-language, 100-word-or-less proposed rule summary will be available in this same docket.

FOR FURTHER INFORMATION CONTACT:
If you have questions about this proposed rulemaking, call or email Petty Officer Brett Lanzel, MSU Pittsburgh, U.S. Coast Guard; telephone 206-815-6624, email Brett.J.Lanzel@uscg.mil.

SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations
CFR Code of Federal Regulations
DHS Department of Homeland Security
FR Federal Register
NPRM Notice of proposed rulemaking
§ Section
U.S.C. United States Code

II. Background, Purpose, and Legal Basis
On February 4, 2025, an organization notified the Coast Guard that it will be conducting a powerboat regatta from 6 a.m. to 6 p.m. on June 7, 2025, and June 8, 2025. The regatta will take place on the Allegheny River between the Mile Markers 20.5 and 21.5 in Creighton, PA. The Captain of the Port Pittsburgh (COTP) has determined that potential hazards associated with the regatta, such as increased vessel traffic, would be a safety concern for any persons or vessels transiting through the area of the Allegheny River on the days of the event.
The purpose of this rulemaking is to ensure the safety of vessels and the navigable waters within the 1-mile regulated area around the racecourse before, during, and after the scheduled event. The Coast Guard is proposing this rulemaking under authority in 46 U.S.C. 70041.

III. Discussion of Proposed Rule
The COTP is proposing to establish a temporary special local regulation from June 7, 2025, through June 8, 2025. The regulated area would cover all navigable waters from Mile Marker 20.5 to 21.5 on the Allegheny River located near Creighton, PA. The Coast Guard anticipates that this regulated area will be enforced between the hours of 5 a.m. and 7 p.m. each day. The duration of the regulation is intended to ensure the safety of vessels and these navigable waters before, during, and after the scheduled event. No vessel or person would be permitted to enter the regulated area without obtaining permission from the COTP or a designated representative. The regulatory text we are proposing appears at the end of this document.

IV. Regulatory Analyses
We developed this proposed rule after considering numerous statutes and Executive orders related to rulemaking. Below we summarize our analyses based on a number of these statutes and Executive orders.

A. Regulatory Planning and Review
Executive Orders 12866 and 13563 direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits. This NPRM has not been designated a “significant regulatory action,” under section 3(f) of Executive Order 12866. Accordingly, the NPRM has not been reviewed by the Office of Management and Budget (OMB).
This regulatory action determination is based on the size, location, and duration of the temporary special local regulation. This regulation impacts only a one mile stretch of the Allegheny River starting June 7, 2025, through June 8, 2025. The regulation will be enforced only during the event, which is anticipated to take place over a two-day period. Vessel traffic will be permitted to transit the area at other times. Moreover, the Coast Guard will issue Local Notice to Mariners (LNMs), Broadcast Notices to Mariners (BNMs), and/or Marine Safety Information Bulletins (MSIBs), via VHF-FM marine channel 13 or 16 about the regulated area and the rule allows vessels to seek permission from the COTP to transit the regulated area.

B. Impact on Small Entities
The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as amended, requires Federal agencies to consider the potential impact of regulations on small entities during rulemaking. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this proposed rule would not have a significant economic impact on a substantial number of small entities.
While some owners or operators of vessels intending to transit the regulated area may be small entities, for the reasons stated in section IV.A above, this proposed rule would not have a significant economic impact on any vessel owner or operator.
If you think that your business, organization, or governmental jurisdiction qualifies as a small entity and that this proposed rule would have a significant economic impact on it, please submit a comment (see ADDRESSES ) explaining why you think it qualifies and how and to what degree this rulemaking would economically affect it.
Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding this proposed rule. If the proposed rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please call or email the person listed in the FOR FURTHER INFORMATION CONTACT section. The Coast Guard will not retaliate against small entities that question or complain about this proposed rule or any policy or action of the Coast Guard.

C. Collection of Information
This proposed rule would not call for a new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

D. Federalism and Indian Tribal Governments
A rule has implications for federalism under Executive Order 13132 (Federalism), if it has a substantial direct effect on the States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government. We have analyzed this proposed rule under that order and have determined that it is consistent with the fundamental federalism principles and preemption requirements described in Executive Order 13132.
Also, this proposed rule does not have Tribal implications under Executive Order 13175 (Consultation and Coordination with Indian Tribal Governments) because it would not have a substantial direct effect on one or more Indian Tribes, on the relationship between the Federal Government and Indian Tribes, or on the distribution of power and responsibilities between the Federal Government and Indian Tribes. If you believe this proposed rule has implications for federalism or Indian Tribes, please call or email the person listed in the FOR FURTHER INFORMATION CONTACT section.

E. Unfunded Mandates Reform Act
The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or Tribal government, in the aggregate, or by the private sector of $100,000,000 (adjusted for inflation) or more in any one year. Though this proposed rule would not result in such an expenditure, we do discuss the potential effects of this proposed rule elsewhere in this preamble.

F. Environment
We have analyzed this proposed rule under Department of Homeland Security Directive 023-01, Rev. 1, associated implementing instructions, and Environmental Planning COMDTINST 5090.1 (series), which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have made a preliminary determination that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This proposed rule involves a temporary special local regulation that impacts only a one mile stretch of the Allegheny River starting June 7, 2025, at 5 a.m., through June 8, 2025, at 7 p.m. Normally such actions are categorically excluded from further review under paragraph L61 of Appendix A, Table 1 of DHS Instruction Manual 023-01-001-01, Rev. 1. We seek any comments or information that may lead to the discovery of a significant environmental impact from this proposed rule.

V. Public Participation and Request for Comments
We view public participation as essential to effective rulemaking and will consider all comments and material received during the comment period. Your comment can help shape the outcome of this rulemaking. If you submit a comment, please include the docket number for this rulemaking, indicate the specific section of this document to which each comment applies, and provide a reason for each suggestion or recommendation.
Submitting comments. We encourage you to submit comments through the Federal Decision-Making Portal at https://www.regulations.gov. To do so, go to https://www.regulations.gov, type USCG-2025-0130 in the search box and click “Search.” Next, look for this document in the Search Results column, and click on it. Then click on the Comment option. If you cannot submit your material by using https://www.regulations.gov, call or email the person in the FOR FURTHER INFORMATION CONTACT section of this proposed rule for alternate instructions.
Viewing material in docket. To view documents mentioned in this proposed rule as being available in the docket, find the docket as described in the previous paragraph, and then select “Supporting & Related Material” in the Document Type column. Public comments will also be placed in our online docket and can be viewed by following instructions on the https://www.regulations.gov Frequently Asked Questions web page. Also, if you click on the Dockets tab and then the proposed rule, you should see a “Subscribe” option for email alerts. The option will notify you when comments are posted, or a final rule is published.
We review all comments received, but we will only post comments that address the topic of the proposed rule. We may choose not to post off-topic, inappropriate, or duplicate comments that we receive.
Personal information. We accept anonymous comments. Comments we post to https://www.regulations.gov will include any personal information you have provided. For more about privacy and submissions to the docket in response to this document, see DHS's eRulemaking System of Records notice (85 FR 14226, March 11, 2020).

List of Subjects in 33 CFR Part 100
Marine safety, Navigation (water), Reporting and recordkeeping requirements, Waterways.
For the reasons discussed in the preamble, the Coast Guard is proposing to amend 33 CFR part 100 as follows:

PART 100—SAFETY OF LIFE ON NAVIGABLE WATERS
1. The authority citation for part 100 continues to read as follows:

Authority:
46 U.S.C. 70041; 33 CFR 1.05-1.
2. Add § 100.T899-0130 to read as follows:
§ 100.T899-0130
Special Local Regulation; Iron City Classic Regatta, Creighton, PA.
(a) Regulated area. All navigable waters on the Allegheny River between mile marker 20.5 and mile marker 21.5.
(b) Definitions. As used in this section:
Designated representative means a Coast Guard Patrol Commander, including any commissioned, warrant, petty officer, a Coast Guard coxswain, petty officer, or other officer operating a Coast Guard vessel, or any Federal, State, or local law enforcement officer who has been designated by the Captain of the Port Pittsburgh (COTP) to act on his or her behalf. The designated representative may be on an official patrol vessel or may be on shore and will communicate with vessels via VHF-FM radio or loudhailer. In addition, members of the Coast Guard Auxiliary may be present to inform vessel operators of this regulation. Official patrol vessels mean any Coast Guard, Coast Guard Auxiliary, state, or local law enforcement vessels assigned or approved by the COTP to enforce this section.
Participant means all persons and vessels registered with the event sponsor as participants in the parade.
(c) Regulations. (1) All non-participants are prohibited from entering, transiting through, anchoring in, or remaining within the regulated area described in paragraph (a) of this section unless authorized by the COTP or the COTP's designated representative.
(2) Any person or vessel permitted to enter the regulated area shall comply with the directions and orders of the COTP or the COTP's designated representative. Any vessel that is granted permission to enter or remain in the regulated area by the COTP or the COTP's designated representative must proceed through the area with caution and operate at a speed no faster than that speed necessary to maintain a safe course, unless otherwise required by the Inland Navigation Rules as set forth in 33 CFR chapter I, subchapter E.
(3) To seek permission to enter the regulated area, contact the COTP or the COTP's representative by VHF Channel 13 or 16, or through the Marine Safety Unit Pittsburgh at 206-815-6624.
(d) Enforcement period. The regulated area in paragraph (a) of this section is in effect from June 7, 2025, through June 8, 2025. The regulated area will be enforced for approximately 14 hours each day of the event, between the hours of 5 a.m. and 7 p.m. The COTP, or a designated representative, will inform the public through written Local Notice to Mariners, and Broadcast Notice to Mariners via VHF-FM marine channel 13 or 16, of the enforcement period of the regulated area.
Dated: March 31, 2025.
Justin R. Jolley,

Commander, U.S. Coast Guard, Captain of the Port, MSU Pittsburgh.
DEPARTMENT OF EDUCATION
34 CFR Chapter VI
[Docket ID ED-2025-OPE-0016]
Negotiated Rulemaking Committee; Negotiator Nominations and Schedule of Committee Meetings

AGENCY:
Office of Postsecondary Education, Department of Education.

ACTION:
Intent to establish rulemaking committee.

SUMMARY:
We announce our intention to establish a negotiated rulemaking committee to prepare proposed regulations for the Federal Student Aid programs authorized under title IV of the Higher Education Act of 1965, as amended (HEA). The committee will include representatives of organizations or groups with interests that are significantly affected by the subject matter of the proposed regulations. We request nominations for individual negotiators who represent key stakeholder constituencies for the issues to be negotiated to serve on the committee.

DATES:
We must receive your nominations for negotiators to serve on the committee on or before June 2, 2025. The dates and times of the committee meetings are set out in the Schedule for Negotiations in the SUPPLEMENTARY INFORMATION section.

ADDRESSES:
Please email your nominations for negotiators to negregnominations@ed.gov. If you are unable to email your nomination, please contact Vanessa Gomez, U.S. Department of Education, Office of Postsecondary Education, 400 Maryland Avenue SW, 5th Floor, Washington, DC 20202. Telephone: (202) 987-0378. Email: NegRegnominations@ed.gov .

FOR FURTHER INFORMATION CONTACT:
For information about negotiated rulemaking, see “The Negotiated Rulemaking Process for Title IV Regulations—Frequently Asked Questions” at https://www.ed.gov/laws-and-policy/higher-education-laws-and-policy/higher-education-policy/frequently-asked-questions-negotiated-rulemaking-process-title-iv-regulations. For information about the content of this document, including additional information about the negotiated rulemaking process, please contact Tamy Abernathy, U.S. Department of Education (Department), Office of Postsecondary Education, 400 Maryland Avenue SW, 5th Floor, Washington, DC 20202. Telephone: (202) 245-4595. Email: NegRegNPRMHelp@ed.gov.
If you are deaf, hard of hearing, or have a speech disability and wish to access telecommunications relay services, please dial 7-1-1.

SUPPLEMENTARY INFORMATION:

Background
On April 4, 2025, we published in the Federal Register 90 FR 14741 an announcement of our intent to establish a negotiated rulemaking committee addressing topics which may include Public Service Loan Forgiveness (PSLF), Pay As You Earn (PAYE), Income-Contingent Repayment (ICR), or other topics that would streamline and improve federal student financial assistance programs and related regulations. We also announced public hearings at which interested parties could comment on the topics for negotiation suggested by the Department and suggest additional topics for consideration for action by one or more negotiated rulemaking committees. Those hearings were held on April 29 and May 1, 2025.
You may view written comments submitted in response to the aforementioned Federal Register document through the Federal eRulemaking Portal at www.regulations.gov. The Department is still receiving comments through May 8, 2025, and will consider suggested additional topics for future negotiations. Instructions for finding comments are available on the site under “FAQ.” Enter Docket ID ED-2025-OPE-0016 in the search box to locate the appropriate docket.

Committee Topics
After considering the information received at the public hearing and the written comments, we have decided to establish the Student Loans and Affordability Committee (Committee) to address the following topics:
1. Refining definitions of a qualifying employer for the purposes of determining eligibility for the Public Service Loan Forgiveness program.
2. Revisiting family size, restructuring repayment plan provisions, including the alternative repayment plan, and certain other provisions of the July 10, 2023 rule.
We intend to select negotiators for the Committee who represent the interests of those significantly affected by the topics proposed for negotiation. In so doing, we will comply with the requirement in section 492(b)(1) of the HEA (20 U.S.C. 1098a) that the individuals selected must have demonstrated expertise or experience in the relevant topics proposed for negotiations. Our goal is to establish a committee that will allow significantly affected parties to be represented while keeping the size manageable.
We generally select a primary and alternate negotiator for each constituency represented on a committee. The primary negotiator participates for the purpose of determining consensus. The alternate participates for the purpose of determining consensus in the absence of the primary negotiator. The Department will provide more detailed information to both primary and alternate negotiators selected to participate on the Committee about the logistics and protocols of the meetings.

Constituencies for Negotiator Nominations
We have identified the following constituencies as having interests that are significantly affected by the topics proposed for negotiation. We plan to include negotiators who represent these constituencies. Nominations should include evidence of the nominee's specific knowledge of the issues listed under the Committee Topics heading earlier in this document. The Department strongly encourages nominees to list all constituencies under which they would like to be considered. The Department reserves the discretion to place a nominee in a constituency based upon their background and experience even if the individual was not nominated for that specific category.
Constituencies for the Committee are:
• Civil rights organizations, consumer advocates, and legal assistance organizations that represent students and/or borrowers.
• State officials, including State higher education executive officers, State authorizing agencies and State attorneys general. Student loan borrowers in repayment.
• U.S. military service members, veterans, or groups representing them.
• Public institutions of higher education, including Historically Black Colleges and Universities, Tribal Colleges and Universities, and Minority-serving institutions (institutions of higher education eligible to receive Federal assistance under title III, parts A and F, and title V of the HEA).
• Private nonprofit institutions of higher education including Historically Black Colleges and Universities, Tribal Colleges and Universities, and Minority-serving institutions (institutions of higher education eligible to receive Federal assistance under title III, parts A and F, and title V of the HEA).
• Proprietary institutions of higher education.
• Financial aid administrators at postsecondary institutions.
• Organizations representing taxpayers and the public interest.
• Federal Family Education Loan Lenders and/or Guaranty Agencies.

Advisor
The Department also invites nominations for an advisor. The advisor will not be a member of the committee and will not impact the consensus vote; however, we will consult with the advisor, who will serve as a resource to the committee for the purposes of expanding the definition of qualifying employment under the Public Service Loan Forgiveness program. We seek an advisor who has the knowledge of Federal immigration laws and laws that prohibit illegal discrimination and curtail domestic support of terrorism. We also seek assistance in defining terms such as, illegal immigration, human smuggling, child trafficking, and other terms mentioned in the March 7, 2025, Presidential Executive Order directing the Secretary to revise 34 CFR 685.219, specifically activities that would exclude an agency from being a qualifying employer. The advisor will be expected to be available throughout the duration of the Student Loans and Affordability Committee meetings, specifically when the committee is discussing issues related to Public Service Loan Forgiveness. The Department will work with the committee and the advisor to determine additional dates and times that the advisor must be present before, in-between, and after committee meetings. The advisor may also offer recommendations to the committee on regulatory language.
The goal of the committee is to develop proposed regulations that reflect a final consensus of the committee. Consensus means that there is no dissent by any member of a negotiating committee, including the committee member representing the Department.
A negotiator is expected to represent the interests of their constituency and to participate in the negotiations in a manner consistent with the goal of developing proposed regulations on which the committee will reach consensus.

Nominations
We request that nominations include the information described in this section.
(1) The name of the nominee;
(2) The name of the constituency (or constituencies) for which the nominee is being nominated (see Constituencies for Negotiator Nominations );
(3) The nominee's place of employment or institution at which they are or were enrolled and, if different, the organization the nominee represents;
(4) A resume or evidence of the nominee's expertise and experience in the topics proposed for negotiations; and
(5) The nominee's contact information, including email address, telephone number, and mailing address.
Please see the ADDRESSES section for submission information. We will confirm receipt of nominations to the submitter. The Department will provide additional information to those we select to serve as negotiators. Once complete, a list of negotiators will be posted here: https://www.ed.gov/laws-and-policy/higher-education-laws-and-policy/higher-education-policy/negotiated-rulemaking-for-higher-education-2025-2026 . The Department will also provide information about how any committee vacancies can be filled at the beginning of the first committee meeting.

Schedule for Negotiations
The Committee will meet in-person at the Department in Washington, DC for one session on the following dates:
Session 1: June 30-July 2, 2025
Session times will be from 9:00 a.m. to 12:00 p.m. and 1:00 p.m. to 4:00 p.m., with a public comment period from approximately 3:30 p.m. to 4:00 p.m., Eastern time.
The session will be conducted in person and is available for the public to view via livestream. The Department is willing to add another session if needed. Registration is requested to observe the in-person or livestream. Space may be limited. We will post a registration link on our website at https://www.ed.gov/laws-and-policy/higher-education-laws-and-policy/higher-education-policy/negotiated-rulemaking-for-higher-education-2025-2026 closer to the start of negotiations. Please note any in-person visitors to the Department must present a Driver's License (DL) or Identification (ID) that is compliant with the REAL ID Act; a current military ID; or a valid passport. Those persons not in possession of a DL/ID that is REAL ID compliant, a current military ID or a valid passport, will not be allowed to gain entrance into the Department. The Department will also post recordings and transcripts of the meetings on the site listed above
At the end of each day (except for the final day of the final session), the Department will reserve 30 minutes for in-person public comment at the Department in Washington, DC. We will attempt to accommodate each speaker's preference, but, if we are unable to do so, we will select speakers on a first-come, first-served basis, based on the date and time we received the message. We will limit each participant to three minutes. We will provide information on how to request time to speak on our website at https://www.ed.gov/laws-and-policy/higher-education-laws-and-policy/higher-education-policy/negotiated-rulemaking-for-higher-education-2025-2026 . For those who need a reasonable modification in order to provide a live comment during the negotiations, please see the “Reasonable Modifications” section below for information about how to make such a request.
Individuals who would like to present comments must register by sending an email message to negreghearing@ed.gov no later than noon, Eastern time, on the business day prior to the committee hearing in which they would like to speak. The message should include the name of the presenter and one or more dates and times during which the individual would be available to speak. The Department will notify registrants of the date and time slot reserved for them to speak. An individual may make only one presentation at the committee meetings. If we receive more registrations than we are able to accommodate, the Department reserves the right to reject the registration of an entity or individual that is affiliated with an entity or individual that is already scheduled to present comments, and to select among registrants to ensure that a broad range of entities and individuals is allowed to present. We will accept registrations for any remaining time slots on a first-come, first-served basis, beginning at 8 a.m., at the Department's on-site registration table.
Accessible Format: On request to the program contact person listed under FOR FURTHER INFORMATION CONTACT , individuals with disabilities can obtain this document in an accessible format. The Department will provide the requestor with an accessible format that may include Rich Text Format (RTF) or text format (txt), a thumb drive, an MP3 file, braille, large print, audiotape, or compact disc, or other accessible format. American Sign Language translation will be provided to all who attend the negotiations and closed captioning will be provided for the negotiations.
Reasonable Modifications: The hearings will be accessible to individuals with disabilities. Information for contacting the Department to request auxiliary aids or services to provide a live comment will be included in the registration process for providing a live comment at the hearing. If you will need an auxiliary aid or service to provide your comment, please notify the person listed under FOR FURTHER INFORMATION CONTACT in this document at least two weeks before the scheduled meeting date.
Electronic Access to this Document: The official version of this document is the document published in the Federal Register . You may access the official edition of the Federal Register and the Code of Federal Regulations at www.govinfo.gov . At this site you can view this document, as well as all other documents of this Department published in the Federal Register , in text or Portable Document Format (PDF). To use PDF, you must have Adobe Acrobat Reader, which is available free at the site. You may also access the documents of the Department published in the Federal Register by using the article search feature at www.federalregister.gov . Specifically, through the advanced search feature at this site, you can limit your search to documents published by the Department.
Program Authority: 20 U.S.C. 1098a.
James P. Bergeron,

Acting Under Secretary.
90
90
Monday, May 12, 2025
Notices
CIVIL RIGHTS COLD CASE RECORDS REVIEW BOARD
[Agency Docket Number: CRCCRRB-2025-0014-N]
Notice of Formal Determination on Records Release

AGENCY:
Civil Rights Cold Case Records Review Board.

ACTION:
Notice.

SUMMARY:
The Civil Rights Cold Case Records Review Board received 425 pages of records from the National Archives and Records Administration (NARA), the Department of Justice, and the Federal Bureau of Investigation (FBI) related to a civil rights cold case incident to which the Review Board assigned the unique identifier 2024-003-016. NARA did not propose any postponements of disclosure. The Department of Justice and the FBI proposed 423 postponements of disclosure. The FBI later withdrew 32 of those postponements. On May 2, 2025, the Review Board approved 120 postponements and portions of 13 additional postponements, and determined that 399 pages in full and 26 pages in part should be publicly disclosed in the Civil Rights Cold Case Records Collection. By issuing this notice, the Review Board complies with the Civil Rights Cold Case Records Collection Act of 2018 that requires the Review Board to publish in the Federal Register its determinations on the disclosure or postponement of records in the Collection no more than 14 days after the date of its decision.

FOR FURTHER INFORMATION CONTACT:
Stephannie Oriabure, Chief of Staff, Civil Rights Cold Case Records Review Board, 1800 F Street NW, Washington, DC 20405, (771) 221-0014, info@coldcaserecords.gov.

SUPPLEMENTARY INFORMATION:
Incident identifier | Postponement identifier | Review board decision
2024-003-016 | 2024-DOJ-03-0260 through 2024-DOJ-03-0333 | Reject.
2024-003-016 | 2024-DOJ-03-0334 | Approve.
2024-003-016 | 2024-DOJ-03-0335 through 2024-DOJ-03-0343 | Reject.
2024-003-016 | 2024-DOJ-03-0344 | Approve.
2024-003-016 | 2024-DOJ-03-0345 through 2024-DOJ-03-0366 | Reject.
2024-003-016 | 2024-DOJ-03-0367 | Approve with changes.
2024-003-016 | 2024-DOJ-03-0368 | Approve.
2024-003-016 | 2024-DOJ-03-0369 through 2024-DOJ-03-0384 | Reject.
2024-003-016 | 2024-DOJ-03-0385 and 2024-DOJ-03-0386 | Approve.
2024-003-016 | 2024-DOJ-03-0387 through 2024-DOJ-03-0390 | Reject.
2024-003-016 | 2024-DOJ-03-0391 | Approve.
2024-003-016 | 2024-DOJ-03-0392 | Reject.
2024-003-016 | 2024-DOJ-03-0393 through 2024-DOJ-03-0395 | Approve.
2024-003-016 | 2024-DOJ-03-0396 and 2024-DOJ-03-0397 | Reject.
2024-003-016 | 2024-DOJ-03-0398 and 2024-DOJ-03-0399 | Approve.
2024-003-016 | 2024-DOJ-03-0400 | Reject.
2024-003-016 | 2024-DOJ-03-0401 through 2024-DOJ-03-0403 | Approve.
2024-003-016 | 2024-DOJ-03-0404 | Approve with changes.
2024-003-016 | 2024-DOJ-03-0405 through 2024-DOJ-03-0407 | Approve.
2024-003-016 | 2024-DOJ-03-0408 | Reject.
2024-003-016 | 2024-DOJ-03-0409 through 2024-DOJ-03-0411 | Approve.
2024-003-016 | 2024-DOJ-03-0412 through 2024-DOJ-03-0421 | Reject.
2024-003-016 | 2024-DOJ-03-0422 through 2024-DOJ-03-0426 | Approve.
2024-003-016 | 2024-DOJ-03-0427 through 2024-DOJ-03-0438 | Reject.
2024-003-016 | 2024-DOJ-03-0439 through 2024-DOJ-03-0442 | Approve.
2024-003-016 | 2024-DOJ-03-0443 through 2024-DOJ-03-0464 | Reject.
2024-003-016 | 2024-DOJ-03-0465 | Approve.
2024-003-016 | 2024-DOJ-03-0466 through 2024-DOJ-03-0476 | Reject.
2024-003-016 | 2024-DOJ-03-0477 | Approve.
2024-003-016 | 2024-DOJ-03-0478 | Reject.
2024-003-016 | 2024-FBI-03-0422 and 2024-FBI-03-0423 | Reject.
2024-003-016 | 2024-FBI-03-0424 and 2024-FBI-03-0425 | Approve.
2024-003-016 | 2024-FBI-03-0426 and 2024-FBI-03-0427 | Reject.
2024-003-016 | 2024-FBI-03-0428 through 2024-FBI-03-0431 | Approve.
2024-003-016 | 2024-FBI-03-0432 | Approve with changes.
2024-003-016 | 2024-FBI-03-0433 through 2024-FBI-03-0448 | Approve.
2024-003-016 | 2024-FBI-03-0449 | Reject.
2024-003-016 | 2024-FBI-03-0450 | Approve.
2024-003-016 | 2024-FBI-03-0451 | Approve with changes.
2024-003-016 | 2024-FBI-03-0452 through 2024-FBI-03-0454 | Approve.
2024-003-016 | 2024-FBI-03-0455 | Approve with changes.
2024-003-016 | 2024-FBI-03-0456 | Approve.
2024-003-016 | 2024-FBI-03-0457 through 2024-FBI-03-0459 | Approve with changes.
| 2024-003-016 | 2024-FBI-03-0460 | Approve.
2024-003-016 | 2024-FBI-03-0461 | Approve with changes.
2024-003-016 | 2024-FBI-03-0462 through 2024-FBI-03-0464 | Approve.
2024-003-016 | 2024-FBI-03-0465 through 2024-FBI-03-0469 | Reject.
2024-003-016 | 2024-FBI-03-0470 | Approve.
2024-003-016 | 2024-FBI-03-0471 through 2024-FBI-03-0473 | Reject.
2024-003-016 | 2024-FBI-03-0474 through 2024-FBI-03-0488 | Approve.
2024-003-016 | 2024-FBI-03-0489 | Reject.
2024-003-016 | 2024-FBI-03-0490 | Approve.
2024-003-016 | 2024-FBI-03-0491 | Approve with changes.
2024-003-016 | 2024-FBI-03-0492 through 2024-FBI-03-0503 | Reject.
2024-003-016 | 2024-FBI-03-0504 | Approve.
2024-003-016 | 2024-FBI-03-0505 through 2024-FBI-03-0509 | Reject.
2024-003-016 | 2024-FBI-03-0510 and 2024-FBI-03-0511 | Approve.
2024-003-016 | 2024-FBI-03-0512 through 2024-FBI-03-0521 | Withdrawn by agency.
2024-003-016 | 2024-FBI-03-0522 and 2024-FBI-03-0523 | Reject.
2024-003-016 | 2024-FBI-03-0524 through 2024-FBI-03-0527 | Withdrawn by agency.
2024-003-016 | 2024-FBI-03-0528 | Reject.
2024-003-016 | 2024-FBI-03-0529 through 2024-FBI-03-0532 | Withdrawn by agency.
2024-003-016 | 2024-FBI-03-0533 | Reject.
2024-003-016 | 2024-FBI-03-0534 | Withdrawn by agency.
2024-003-016 | 2024-FBI-03-0535 and 2024-FBI-03-0536 | Approve.
2024-003-016 | 2024-FBI-03-0537 | Reject.
2024-003-016 | 2024-FBI-03-0538 and 2024-FBI-03-0539 | Withdrawn by agency.
2024-003-016 | 2024-FBI-03-0540 | Reject.
2024-003-016 | 2024-FBI-03-0541 through 2024-FBI-03-0544 | Withdrawn by agency.
2024-003-016 | 2024-FBI-03-0545 | Reject.
2024-003-016 | 2024-FBI-03-0546 | Withdrawn by agency.
2024-003-016 | 2024-FBI-03-0547 and 2024-FBI-03-0548 | Approve.
2024-003-016 | 2024-FBI-03-0549 | Reject.
2024-003-016 | 2024-FBI-03-0550 and 2024-FBI-03-0551 | Withdrawn by agency.
2024-003-016 | 2024-FBI-03-0552 through 2024-FBI-03-0557 | Reject.
2024-003-016 | 2024-FBI-03-0558 | Approve.
2024-003-016 | 2024-FBI-03-0559 | Withdrawn by agency.
2024-003-016 | 2024-FBI-03-0560 through 2024-FBI-03-0562 | Reject.
2024-003-016 | 2024-FBI-03-0563 through 2024-FBI-03-0577 | Approve.
2024-003-016 | 2024-FBI-03-0578 | Reject.
2024-003-016 | 2024-FBI-03-0579 | Approve with changes.
2024-003-016 | 2024-FBI-03-0580 | Approve.
2024-003-016 | 2024-FBI-03-0581 through 2024-FBI-03-0593 | Reject.
2024-003-016 | 2024-FBI-03-0594 | Withdrawn by agency.
2024-003-016 | 2024-FBI-03-0595 through 2024-FBI-03-0599 | Approve.
2024-003-016 | 2024-FBI-03-0600 | Reject.
2024-003-016 | 2024-FBI-03-0601 through 2024-FBI-03-0603 | Approve.
2024-003-016 | 2024-FBI-03-0604 and 2024-FBI-03-0605 | Reject.
2024-003-016 | 2024-FBI-03-0606 and 2024-FBI-03-0607 | Approve.
2024-003-016 | 2024-FBI-03-0608 | Approve with changes.
2024-003-016 | 2024-FBI-03-0609 through 2024-FBI-03-0611 | Approve.
2024-003-016 | 2024-FBI-03-0612 and 2024-FBI-03-0613 | Reject.
2024-003-016 | 2024-FBI-03-0614 | Approve.
2024-003-016 | 2024-FBI-03-0615 | Withdrawn by agency.
2024-003-016 | 2024-FBI-03-0616 and 2024-FBI-03-0617 | Approve.
2024-003-016 | 2024-FBI-03-0618 | Withdrawn by agency.
2024-003-016 | 2024-FBI-03-0619 | Reject.
2024-003-016 | 2024-FBI-03-0620 | Approve with changes.
2024-003-016 | 2024-FBI-03-0621 through 2024-FBI-03-0623 | Approve.
2024-003-016 | 2024-FBI-03-0624 | Reject.
2024-003-016 | 2024-FBI-03-0625 | Approve.
Authority: Pub. L. 115-426, 132 Stat. 5489 (44 U.S.C. 2107).
Dated: May 7, 2025.
Stephannie Oriabure,

Chief of Staff.
COMMISSION ON CIVIL RIGHTS
Sunshine Act Meeting

AGENCY:
United States Commission on Civil Rights.

ACTION:
Notice of Commission public business meeting.

DATES:
Friday, May 16, 2025, 10 a.m. EST.

ADDRESSES:
Meeting to take place virtually and is open to the public via livestream on the Commission's YouTube page: https://www.youtube.com/user/USCCR/videos.

FOR FURTHER INFORMATION CONTACT:
Joe Kim: 202-499-0263. publicaffairs@usccr.gov .

SUPPLEMENTARY INFORMATION:
In accordance with the Government in Sunshine Act (5 U.S.C. 552b), the Commission on Civil Rights is holding a meeting to discuss the Commission's business for the month of May. This business meeting is open to the public. Computer assisted real-time transcription (CART) will be provided. The web link to access CART (in English) on Friday, May 16, 2025, is https://www.streamtext.net/player?event=USCCR. Please note that CART is text-only translation that occurs in real time during the meeting and is not an exact transcript.

Meeting Agenda
I. Approval of Agenda
II. Business Meeting
A. Discussion and Vote on the planning documents for the 2025 Briefing Report Topic on Mental Health in Juvenile Justice.
B. Discussion and Vote on State Advisory Committee Appointments.
C. Management and Operations.
• Staff Director's Report
III. Adjourn Meeting
Dated: May 8, 2025.
David Mussatt,

Supervisory Chief, Regional Programs Unit.
COMMISSION ON CIVIL RIGHTS
Notice of Public Meeting of the Florida Advisory Committee to the U.S. Commission on Civil Rights

AGENCY:
U.S. Commission on Civil Rights.

ACTION:
Notice of public meeting.

SUMMARY:
Notice is hereby given, pursuant to the provisions of the rules and regulations of the U.S. Commission on Civil Rights (Commission) and the Federal Advisory Committee Act, that the Florida Advisory Committee (Committee) to the U.S. Commission on Civil Rights will hold a public meeting via Zoom at 3 p.m. eastern time (ET) on Monday, May 19, 2025. The purpose of the meeting is to discuss the Committee's project, “Voting Rights and Emergency Preparedness in Florida”.

DATES:
Monday, May 19, 2025, from 3 p.m.-4 p.m. ET.

ADDRESSES:
The meeting will be held via Zoom Webinar.
Registration Link (Audio/Visual): https://www.zoomgov.com/webinar/register/WN_ZXFSHxjfR8Si7G64b3Dd9A.
Join by Phone (Audio Only): (833) 435-1820 USA Toll-Free; Meeting ID: 161 522 8006.

FOR FURTHER INFORMATION CONTACT:
Melissa Wojnaroski, Designated Federal Officer, at mwojnaroski@usccr.gov or (202) 618-4158.

SUPPLEMENTARY INFORMATION:
This committee meeting is available to the public through the registration link above. Any interested member of the public may listen to the meeting. An open comment period will be provided to allow members of the public to make a statement as time allows. Per the Federal Advisory Committee Act, public minutes of the meeting will include a list of persons who are present at the meeting. If joining via phone, callers can expect to incur regular charges for calls they initiate over wireless lines, according to their wireless plan. The Commission will not refund any incurred charges. Callers will incur no charge for calls they initiate over land-line connections to the toll-free telephone number. Closed captioning will be available for individuals who are deaf, hard of hearing, or who have certain cognitive or learning impairments. To request additional accommodations, please email Liliana Schiller, Support Services Specialist, at lschiller@usccr.gov at least 10 business days prior to the meeting.
Members of the public are entitled to submit written comments; the comments must be received in the regional office within 30 days following the meeting. Written comments may be emailed to Melissa Wojnaroski at mwojnaroski@usccr.gov. Persons who desire additional information may contact the Regional Programs Coordination Unit at (202) 618-4158.
Records generated from this meeting may be inspected and reproduced at the Regional Programs Coordination Unit Office, as they become available, both before and after the meeting. Records of the meetings will be available via the file sharing website, www.box.com. Persons interested in the work of this Committee are directed to the Commission's website, http://www.usccr.gov, or may contact the Regional Programs Coordination Unit at the above phone number.

Agenda
I. Welcome & Roll Call
II. Committee Discussion: Voting Rights & Emergency Preparedness in Florida
III. Public Comment
IV. Next Steps
V. Adjournment
Exceptional Circumstance: Pursuant to 41 CFR 102-3.150, the notice for this meeting is given less than 15 calendar days prior to the meeting due to the availability of staff and the Committee.
Dated: May 6, 2025.
David Mussatt,

Supervisory Chief, Regional Programs Unit.
DEPARTMENT OF COMMERCE
International Trade Administration
[A-570-182]
Thermoformed Molded Fiber Products From the People's Republic of China: Preliminary Affirmative Determination of Sales at Less Than Fair Value, Postponement of Final Determination and Extension of Provisional Measures

AGENCY:
Enforcement and Compliance, International Trade Administration, Department of Commerce.

SUMMARY:
The U.S. Department of Commerce (Commerce) preliminarily determines that thermoformed molded fiber products from the People's Republic of China (China) are being, or are likely to be, sold in the United States at less than fair value (LTFV). The period of investigation is April 1, 2024, through September 30, 2024. Interested parties are invited to comment on this preliminary determination.

DATES:
Applicable May 12, 2025.

FOR FURTHER INFORMATION CONTACT:
Dennis McClure or Matthew Lipka, AD/CVD Operations, Office VIII, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone: (202) 482-5973 or (202) 482-7976, respectively.

SUPPLEMENTARY INFORMATION:

Background
This preliminary determination is made in accordance with section 733(b) of the Tariff Act of 1930, as amended (the Act). Commerce published the notice of initiation of this investigation on November 4, 2024. ^1 On March 4, 2025, Commerce postponed the preliminary determination of this investigation, and the revised deadline is now May 6, 2025. ^2
^1 See Thermoformed Molded Fiber Products From the People's Republic of China and the Socialist Republic of Vietnam: Initiation of Less-Than-Fair-Value Investigations , 89 FR 87551 (November 4, 2024) ( Initiation Notice ).
^2 See Thermoformed Molded Fiber Products from the People's Republic of China and the Socialist Republic of Vietnam: Postponement of Preliminary Determinations in the Less-Than-Fair Value Investigations, 90 FR 11153 (March 4, 2025).
For a complete description of the events that followed the initiation of this investigation, see the Preliminary Decision Memorandum. ^3 A list of topics included in the Preliminary Decision Memorandum is included as Appendix II to this notice. The Preliminary Decision Memorandum is a public document and is on file electronically via Enforcement and Compliance's Antidumping and Countervailing Duty Centralized Electronic Service System (ACCESS). ACCESS is available to registered users at https://access.trade.gov. In addition, a complete version of the Preliminary Decision Memorandum can be accessed directly at https://access.trade.gov/public/FRNoticesListLayout.aspx.
^3 See Memorandum, “Decision Memorandum for the Preliminary Affirmative Determination in the Less-Than-Fair-Value Investigation of Thermoformed Molded Fiber Products from the People's Republic of China,” dated concurrently with, and hereby adopted by, this notice (Preliminary Decision Memorandum).

Scope of the Investigation
The product covered by this investigation is thermoformed molded fiber products from China. For a complete description of the scope of this investigation, see Appendix I.

Scope Comments
In accordance with the Preamble to Commerce's regulations, ^4 the Initiation Notice set aside a period of time for parties to raise issues regarding product coverage ( i.e., scope). ^5 On November 25, 2024, interested parties submitted comments on the scope of this investigation and, on December 5, 2024, the American Molded Fiber Coalition (the petitioners) responded to these scope comments. ^6 For a summary of the product coverage comments and rebuttal responses submitted to the record for this investigation and accompanying discussion and analysis of all comments timely received, see the Preliminary Scope Decision Memorandum. ^7 Commerce is preliminarily modifying the scope language as it appeared in the Initiation Notice. See the revised scope in Appendix I to this notice.
^4 See Antidumping Duties; Countervailing Duties, Final Rule, 62 FR 27296, 27323 (May 19, 1997) ( Preamble ).
^5 See Initiation Notice, 89 FR at 87552.
^6 See Eco-Products, PBC's Letter, “Scope Comments,” dated November 25, 2024; see also World Centric's Letter, “World Centric Scope Comments,” dated November 25, 2024; Target General Merchandise, Inc.'s Letter, “Scope Comments on Behalf of Target General Merchandise, Inc.,” dated November 25, 2024; and Petitioners' Letter, “Petitioners' Response to Scope Comments,” dated December 5, 2024.
^7 See Memorandum, “Less-Than-Fair-Value and Countervailing Duty Investigations of Thermoformed Molded Fiber Products from the People's Republic of China and the Socialist Republic of Vietnam: Preliminary Scope Decision Memorandum,” dated concurrently with this notice (Preliminary Scope Decision Memorandum).

Methodology
Commerce is conducting this investigation in accordance with section 731 of the Act. Commerce has calculated export prices in accordance with section 772(a) of the Act and constructed export prices in accordance with section 772(b) of the Act. Because China is a non-market economy (NME), within the meaning of section 771(18) of the Act, Commerce has calculated normal value in accordance with section 773(c) of the Act. Furthermore, pursuant to sections 776(a) and (b) of the Act, Commerce preliminarily has relied upon facts otherwise available, with adverse inferences, for the China-wide entity, which includes (1) Be Green Packaging Co., Ltd., (2) Greenland Industrial Limited, (3) Sabert (Zhongshan) Limited, (4) Shanghai Veridian International Co. LTD, (5) Shanghai Yingzhenghui Green Industrial Co., Ltd., (6) Zhejiang Beehive Trading Company, (7) Zhejiang Enjoy & Wonderful Inc., and (8) Zhejiang Jiadebao Technology Co., Ltd. In addition, Commerce has applied partial facts otherwise available, with adverse inferences, to mandatory respondents Guangxi Firstpak Environmental Technology Co., Ltd. (Guangxi Firstpak) and the collapsed single entity that includes mandatory respondent Zhejiang Zhongxin Environmental Protection Technology Group Co., Ltd. (Zhejiang Zhongxin). ^8 For a full description of the methodology underlying Commerce's preliminary determination, see the Preliminary Decision Memorandum.
^8 Commerce has preliminarily determined that the mandatory respondent Zhejiang Zhongxin is affiliated with the following companies and has treated these companies as a single entity: (1) Chongzuo Zhongxin Environmental Protection Technology Co., Ltd.; (2) Guangxi Huabao Fiber Products Co,. Ltd.; (3) Jinhua Zhongsheng Fiber Products Co., Ltd.; and (4) Hangzhou Ganzhejun Environmental Protection Technology Co., Ltd (collectively, the Zhongxin Group). See the Preliminary Decision Memorandum for further details.

Combination Rates
In the Initiation Notice, ^9 Commerce stated that it would calculate producer/exporter combination rates for the respondents that are eligible for a separate rate in this investigation. Policy Bulletin 05.1 describes this practice. ^{10}
^9 See Initiation Notice, 89 FR at 87554-87555.
^{10} See Enforcement and Compliance's Policy Bulletin No. 05.1, regarding, “Separate-Rates Practice and Application of Combination Rates in Antidumping Investigations involving Non-Market Economy Countries,” (April 5, 2005) (Policy Bulletin 05.1), available on Commerce's website at https://enforcement.trade.gov/policy/bull05-1.pdf.

Separate Rates
We preliminarily granted a separate rate to certain respondents that we did not select for individual examination. ^{11} In calculating the rate for non-individually examined separate rate respondents in an NME LTFV investigation, Commerce normally looks to section 735(c)(5)(A) of the Act, which pertains to the calculation of the all-others rate in a market economy LTFV investigation, for guidance. Pursuant to section 735(c)(5)(A) of the Act, normally this rate shall be an amount equal to the weighted-average of the estimated weighted-average dumping margins established for those companies individually examined, excluding zero and de minimis dumping margins, and any dumping margins based entirely under section 776 of the Act.
^{11} See the Preliminary Decision Memorandum for additional details.
In this investigation, Commerce calculated individual estimated weighted-average dumping margins for Guangxi Firstpak and the Zhongxin Group that are not zero, de minimis, or based entirely on facts otherwise available. Thus, the weighted-average dumping margins calculated for Guangxi Firstpak and the Zhongxin Group are the basis to determine the weighted-average dumping margin for the non-examined, separate rate companies in this investigation. ^{12}
See the table below in the “Preliminary Determination” section of this notice.
^{12} See Memorandum, “Calculation of the Dumping Margin for Respondents Not Selected for Individual Examination,” dated concurrently with this notice.

Preliminary Determination
Commerce preliminarily determines that the following estimated weighted-average dumping margins exist:
Exporter | Producer | Estimated weighted- average dumping margin (percent) | Cash deposit rate (adjusted for subsidy offsets) (percent)
Guangxi Firstpak Environmental Technology Co., Ltd | Guangxi Firstpak Environmental Technology Co., Ltd | 47.44 | 47.44
Zhejiang Zhongxin Environmental Protection Technology Group Co., Ltd./Chongzuo Zhongxin Environmental Protection Technology Co., Ltd./Guangxi Huabao Fiber Products Co., Ltd./Hangzhou Ganzhejun Environmental Protection Technology Co., Ltd./Jinhua Zhongsheng Fiber Products Co., Ltd | Zhejiang Zhongxin Environmental Protection Technology Group Co., Ltd./Chongzuo Zhongxin Environmental Protection Technology Co., Ltd./Guangxi Huabao Fiber Products Co., Ltd./Hangzhou Ganzhejun Environmental Protection Technology Co., Ltd./Jinhua Zhongsheng Fiber Products Co., Ltd | 470.63 | 470.36
Xiamen Win Win Bag Co., Ltd | Shandong Yijia Packaging Technology Co., Ltd | 345.98 | 345.84
Anhui Shangjia Environmental Tableware Co., Ltd | Anhui Shangjia Environmental Tableware Co., Ltd | 345.98 | 345.84
Shandong Tranlin Straw New Environmental Technology Joint Stock Company Limited | Shandong Tranlin Straw New Environmental | 345.98 | 345.84
Shandong Teanhe Hongsheng International Trade Co., Ltd | Shandong Tranlin Straw New Environmental | 345.98 | 345.84
Zhejiang Kingsun Eco-Pack Co. Ltd | Zhejiang Kingsun Eco-Pack Co. Ltd | 345.98 | 345.84
Zhejiang Kingsun Eco-Pack Co. Ltd | Guangxi Jiefeng Biological Technology Co., Ltd | 345.98 | 345.84
Guangxi Jiefeng Biological Technology Co., Ltd | Guangxi Jiefeng Biological Technology Co., Ltd | 345.98 | 345.84
Guangxi Fineshine ECO Technology Co., Ltd | Guangxi Fineshine ECO Technology Co., Ltd | 345.98 | 345.84
Wenzhou Sanxing Eco-Friendly Packaging Co., Ltd | Wenzhou Sanxing Eco-Friendly Packaging Co., Ltd | 345.98 | 345.84
Guangdong Shaoneng Group Luzhou Technology Development Co., Ltd | Shaoneng Group Luzhou Eco (Xinfeng) Technology Co., Ltd | 345.98 | 345.84
Guangdong Shaoneng Group Luzhou Technology Development Co., Ltd | Shaoneng Group Guangdong Luzhou Eco Technology Co., Ltd | 345.98 | 345.84
Shaoneng Group Luzhou Eco (Xinfeng) Technology Co., Ltd | Shaoneng Group Guangdong Luzhou Eco Technology Co., Ltd | 345.98 | 345.84
Shaoneng Group Luzhou Eco (Xinfeng) Technology Co., Ltd | Longyan Green Olive Co., Ltd | 345.98 | 345.84
Shaoneng Group Luzhou Eco (Xinfeng) Technology Co., Ltd | Hebei Daoxiang Eco Technology Co., Ltd | 345.98 | 345.84
Shaoneng Group Luzhou Eco (Xinfeng) Technology Co., Ltd | Guangxi Fineshine ECO Technology Co., Ltd | 345.98 | 345.84
Shaoneng Group Luzhou Eco (Xinfeng) Technology Co., Ltd | Zhejiang Fuchang Environmental Protection Technology Co., Ltd | 345.98 | 345.84
Shaoneng Group Guangdong Luzhou Eco Technology Co., Ltd | Cangzhou Jinda Packaging Products Co., Ltd | 345.98 | 345.84
Shaoneng Group Guangdong Luzhou Eco Technology Co., Ltd | Minjie Eco-Machinery Technology Co., Ltd | 345.98 | 345.84
Shaoneng Group Guangdong Luzhou Eco Technology Co., Ltd | Shaoneng Group Luzhou Eco (XinFeng) Technology Co., Ltd | 345.98 | 345.84
Shaoneng Group Guangdong Luzhou Eco Technology Co., Ltd | Hainan Huandu Biotechnology Co., Ltd | 345.98 | 345.84
Shaoneng Group Guangdong Luzhou Eco Technology Co., Ltd | Hebei Daoxiang Eco Technology Co., Ltd | 345.98 | 345.84
Shaoneng Group Guangdong Luzhou Eco Technology Co., Ltd | HuiZhou Gold-Superman Packing Material Co., Ltd | 345.98 | 345.84
Shaoneng Group Guangdong Luzhou Eco Technology Co., Ltd | Nanxiong Taihua Plastic Products Co., Ltd | 345.98 | 345.84
Shaoneng Group Guangdong Luzhou Eco Technology Co., Ltd | NAN Xiong Yangxin ECO Packing Co., Ltd | 345.98 | 345.84
Shaoneng Group Guangdong Luzhou Eco Technology Co., Ltd | NAN Xiong Yangxin ECO Packing Co., Ltd | 345.98 | 345.84
Shaoneng Group Guangdong Luzhou Eco Technology Co., Ltd | Shandong Qizheng Packaging Co., Ltd | 345.98 | 345.84
Shaoneng Group Guangdong Luzhou Eco Technology Co., Ltd | Zhejiang Fuchang Environmental Protection Technology Co., Ltd | 345.98 | 345.84
Shaoneng Group Guangdong Luzhou Eco Technology Co., Ltd | Jiangmen Zhuoyu Technology Co., Ltd | 345.98 | 345.84
Shaoneng Group Guangdong Luzhou Eco Technology Co., Ltd | Dongguan Lvluo Environmental Protection Technology Co., Ltd | 345.98 | 345.84
Shaoneng Group Guangdong Luzhou Eco Technology Co., Ltd | Nanxiong Aerospace Health Technology Co., Ltd | 345.98 | 345.84
Clean Packaging Technology (Shenzhen) Co., Ltd | GreenDoer Advanced Materials, Co., Ltd | 345.98 | 345.84
Ningbo HomeLink Eco-itech Co., Ltd | Zhejiang Jiadebao Technology Co., Ltd | 345.98 | 345.84
Ningbo HomeLink Eco-itech Co., Ltd | Guangxi Ecolink Technology Co., Ltd | 345.98 | 345.84
Guangxi Ecolink Technology Co., Ltd | Guangxi Ecolink Technology Co., Ltd | 345.98 | 345.84
Shandong Shengquan New Materials Co., Ltd | Shandong Shengquan New Materials Co., Ltd | 345.98 | 345.84
Jiangsu Jinsheng Environmental Protection Tableware Co., Ltd | Jiangsu Jinsheng Environmental Protection Tableware Co., Ltd | 345.98 | 345.84
| Hubei Wheat-Straw Environmental Technologies Co., Ltd | Hubei Wheat-Straw Environmental Technologies Co., Ltd | 345.98 | 345.84
Shandong Lvhe Packaging Co., Ltd | Shandong Tranlin Straw New Environmental Technology Joint Stock Company Limited | 345.98 | 345.84
Yibin YUTO Eco Packaging Technology Co., Ltd | Yibin YUTO Eco Packaging Technology Co., Ltd | 345.98 | 345.84
HaiKou YUTO Eco Technology Co., Ltd | HaiKou YUTO Eco Technology Co., Ltd | 345.98 | 345.84
Xiamen Target Trade Co., Ltd | GeoTegrity Eco Pack (Xiamen) Co., Ltd | 345.98 | 345.84
Guangzhou Jiurong Packaging Co., Ltd | Guandong Fenghua Paper Co., Ltd | 345.98 | 345.84
Guangzhou Jiurong Packaging Co., Ltd | Zhejiang Guangju Paper Products Co., Ltd | 345.98 | 345.84
Guangzhou Jiurong Packaging Co., Ltd | Shaoneng Group Guangdong Luzhou Eco Technology Co., Ltd | 345.98 | 345.84
Guangzhou Jiurong Packaging Co., Ltd | Shaoneng Group Luzhou (Xinfeng) Technology Co., Ltd | 345.98 | 345.84
Guangdong Huilin Packaging Technology Group Co., Ltd | Shenzhen Pinchuang Supply Chain Co., Ltd | 345.98 | 345.84
Guangdong Huilin Packaging Technology Group Co., Ltd | Pinchuang Fabric Products Factory | 345.98 | 345.84
Fujian Lvwei Environmental Protection Tableware Co., Ltd | Fujian Qingshan Paper Industry Co., Ltd | 345.98 | 345.84
Fujian Lvwei Environmental Protection Tableware Co., Ltd | Suzhou Pchem New Energy Technology Co., Ltd | 345.98 | 345.84
Fujian Lvwei Environmental Protection Tableware Co., Ltd | Positive energy machinery processing plant | 345.98 | 345.84
Fujian Lvwei Environmental Protection Tableware Co., Ltd | Yangzhou Cannaan Mesh Belt Co., Ltd | 345.98 | 345.84
Fujian Lvwei Environmental Protection Tableware Co., Ltd | Guangxi Boguan Environmental Products Co., Ltd | 345.98 | 345.84
Fujian Lvwei Environmental Protection Tableware Co., Ltd | Guangxi Liantuo Trading Co., Ltd | 345.98 | 345.84
Fujian Lvwei Environmental Protection Tableware Co., Ltd | Shanghai Tingli Environmental Protection Technology Co., Ltd | 345.98 | 345.84
Fujian Lvwei Environmental Protection Tableware Co., Ltd | Guangdong Liangshi Industrial Materials Co., Ltd | 345.98 | 345.84
Fujian Lvwei Environmental Protection Tableware Co., Ltd | Wenzhou Honglian Packaging Container Co., Ltd | 345.98 | 345.84
Fujian Lvwei Environmental Protection Tableware Co., Ltd | Zhenghe County Fenghua Packaging Co., Ltd | 345.98 | 345.84
Wenzhou Keyi Environmental Protection Tableware Co., Ltd | Fujian Qingshan Paper Industry Co., Ltd | 345.98 | 345.84
Wenzhou Keyi Environmental Protection Tableware Co., Ltd | Suzhou Pchem New Energy Technology Co., Ltd | 345.98 | 345.84
Wenzhou Keyi Environmental Protection Tableware Co., Ltd | Wenzhou Shunfu Packaging Co., Ltd | 345.98 | 345.84
Wenzhou Keyi Environmental Protection Tableware Co., Ltd | Wenzhou Xinao Energy Development Co. Ltd | 345.98 | 345.84
Wenzhou Keyi Environmental Protection Tableware Co., Ltd | Ningbo Lufeng Logistics Co., Ltd | 345.98 | 345.84
Wenzhou Keyi Environmental Protection Tableware Co., Ltd | Positive energy machinery processing plant | 345.98 | 345.84
Wenzhou Keyi Environmental Protection Tableware Co., Ltd | Yangzhou Cannaan Mesh Belt Co., Ltd | 345.98 | 345.84
Wenzhou Keyi Environmental Protection Tableware Co., Ltd | Guangxi Boguan Environmental Products Co., Ltd | 345.98 | 345.84
Wenzhou Keyi Environmental Protection Tableware Co., Ltd | Guangxi Liantuo Trading Co., Ltd | 345.98 | 345.84
Wenzhou Keyi Environmental Protection Tableware Co., Ltd | Wenzhou Yongdian Technology Co., Ltd | 345.98 | 345.84
Wenzhou Keyi Environmental Protection Tableware Co., Ltd | Wandu packaging products factory | 345.98 | 345.84
Wenzhou Keyi Environmental Protection Tableware Co., Ltd | Fujian Qingshan Paper Industry Co., Ltd | 345.98 | 345.84
Wenzhou Keyi Environmental Protection Tableware Co., Ltd | Wenzhou Honglian Packaging Container Co., Ltd | 345.98 | 345.84
Wenzhou Keyi Environmental Protection Tableware Co., Ltd | Shanghai Tingli Environmental Protection Technology Co., Ltd | 345.98 | 345.84
Wenzhou Keyi Environmental Protection Tableware Co., Ltd | Guangdong Liangshi Industrial Materials Co., Ltd | 345.98 | 345.84
Fuzhou Hengli Paper Co., Ltd | Shaoneng Group Guangdong Luzhou Eco Technology Co., Ltd | 345.98 | 345.84
| Fuzhou Hengli Paper Co., Ltd | Shenzhen Yike Environmental Resources Co., Ltd | 345.98 | 345.84
Sabert Asia Holdings Limited | Sabert (Zhongshan) Limited | 345.98 | 345.84
China-Wide Entity | * 477.97 | * 477.97
* This rate is based on facts available with adverse inferences.

Suspension of Liquidation
In accordance with section 733(d)(2) of the Act, Commerce will direct U.S. Customs and Border Protection (CBP) to suspend liquidation of subject merchandise as described in the scope of the investigation section entered, or withdrawn from warehouse, for consumption on or after the date of publication of this notice in the Federal Register , as discussed below. Further, pursuant to section 733(d)(1)(B) of the Act and 19 CFR 351.205(d), Commerce will instruct CBP to require a cash deposit equal to the weighted average amount by which normal value exceeds U.S. price, as indicated in the chart above, as follows: (1) for the producer/exporter combinations listed in the table above, the cash deposit rate is equal to the estimated weighted-average dumping margin listed for that combination in the table; (2) for all combinations of Chinese producers/exporters of merchandise under consideration that have not established eligibility for their own separate rates, the cash deposit rate will be equal to the estimated weighted-average dumping margin established for the China-wide entity; and (3) for all third-country exporters of merchandise under consideration not listed in the table above, the cash deposit rate is the cash deposit rate applicable to the Chinese producer/exporter combination (or the China-wide entity) that supplied that third-country exporter.
To determine the cash deposit rate, Commerce normally adjusts the estimated weighted-average dumping margin by the amount of domestic subsidy pass-through and export subsidies determined in a companion countervailing duty (CVD) proceeding when CVD provisional measures are in effect. Accordingly, where Commerce has made a preliminary affirmative determination for domestic subsidy pass-through or export subsidies, Commerce has offset the calculated estimated weighted-average dumping margin by the appropriate rate(s). Any such adjusted rates may be found in the Preliminary Determination section's chart of estimated weighted-average dumping margins, above.
Should provisional measures in the companion CVD investigation expire prior to the expiration of provisional measures in this LTFV investigation, Commerce will direct CBP to begin collecting cash deposits at a rate equal to the estimated weighted-average dumping margins calculated in this preliminary determination unadjusted for the passed-through domestic subsidies or for export subsidies at the time the CVD provisional measures expire.
These suspension of liquidation instructions will remain in effect until further notice.

Disclosure
Commerce intends to disclose to interested parties the calculations performed in connection with this preliminary determination within five days of its public announcement or, if there is no public announcement, within five days of the date of publication of this notice in accordance with 19 CFR 351.224(b).
Consistent with 19 CFR 351.224(e), Commerce will analyze and, if appropriate, correct any timely allegations of significant ministerial errors by amending the preliminary determination. However, consistent with 19 CFR 351.224(d), Commerce will not consider incomplete allegations that do not address the significance standard under 19 CFR 351.224(g) following the preliminary determination. Instead, Commerce will address such allegations in the final determination together with issues raised in the case briefs or other written comments.

Verification
As provided in section 782(i)(1) of the Act, Commerce intends to verify information relied upon in making its final determination.

Public Comment
All interested parties are invited to comment on Commerce's Preliminary Scope Decision Memorandum in scope case and scope rebuttal briefs. The deadline for interested parties to submit scope case briefs is 30 days after the issuance of the Preliminary Scope Decision Memorandum. Scope rebuttal briefs, limited to issues raised in the scope case briefs, may be submitted no later than seven days after the deadline for the scope case briefs. Scope case and rebuttal briefs must be filed simultaneously, via ACCESS, on the records of the LTFV and CVD investigations of thermoformed molded fiber products from China and the Socialist Republic of Vietnam.
Case briefs or other written comments, excluding scope comments, may be submitted to the Assistant Secretary for Enforcement and Compliance no later than seven days after the date on which the last final verification report is issued in this investigation. A timeline for the submission of case briefs and written comments will be provided to interested parties at a later date. Rebuttal briefs, limited to issues raised in the case briefs, may be filed not later than five days after the date for filing case briefs. ^{13} Interested parties who submit case or rebuttal briefs in this proceeding must submit: (1) a table of contents listing each issue; and (2) a table of authorities. ^{14}
^{13} See 19 CFR 351.309(d); see also Administrative Protective Order, Service, and Other Procedures in Antidumping and Countervailing Duty Proceedings, 88 FR 67069, 67077 (September 29, 2023) ( APO and Service Final Rule ).
^{14} See 19 351.309(c)(2) and (d)(2)
As provided under 19 CFR 351.309(c)(2) and (d)(2), in prior proceedings we have encouraged interested parties to provide an executive summary of their brief that should be limited to five pages total, including footnotes. In this investigation, we instead request that interested parties provide at the beginning of their briefs a public, executive summary for each issue raised in their briefs. ^{15} Further, we request that interested parties limit their executive summary of each issue to no more than 450 words, not including citations. We intend to use the executive summaries as the basis of the comment summaries included in the issues and decision memorandum that will accompany the final determination in this investigation. We request that interested parties include footnotes for relevant citations in the executive summary of each issue. Note that Commerce has amended certain of its requirements pertaining to the service of documents in 19 CFR 351.303(f). ^{16}
^{15} We use the term “issue” here to describe an argument that Commerce would normally address in a comment of the Issues and Decision Memorandum.
^{16} See APO and Service Final Rule.
Pursuant to 19 CFR 351.310(c), interested parties who wish to request a hearing, limited to issues raised in the case and rebuttal briefs, must submit a written request to the Assistant Secretary for Enforcement and Compliance, U.S. Department of Commerce, within 30 days after the date of publication of this notice. Requests should contain (1) the party's name, address, and telephone number; (2) the number of participants and whether any participant is a foreign national; and (3) a list of the issues to be discussed. If a request for a hearing is made, Commerce intends to hold the hearing at a time and date to be determined.

Postponement of Final Determination and Extension of Provisional Measures
Section 735(a)(2) of the Act provides that a final determination may be postponed until not later than 135 days after the date of the publication of the preliminary determination if, in the event of an affirmative preliminary determination, a request for such postponement is made by exporters who account for a significant proportion of exports of the subject merchandise, or in the event of a negative preliminary determination, a request for such postponement is made by the petitioner. Pursuant to 19 CFR 351.210(e)(2), Commerce requires that requests by respondents for postponement of a final antidumping duty determination be accompanied by a request for extension of provisional measures from a four-month period to a period not more than six months in duration.
On April 9, 2025, Guangxi Firstpak requested that Commerce postpone the final determination and that provisional measures be extended to a period not to exceed six months. ^{17} In accordance with section 735(a)(2)(A) of the Act and 19 CFR 351.210(b)(2)(ii), because: (1) the preliminary determination is affirmative; (2) the requesting exporter accounts for a significant proportion of exports of the subject merchandise; and (3) no compelling reasons for denial exist, Commerce is postponing the final determination and extending the provisional measures from a four-month period to a period not greater than six months. Accordingly, Commerce will make its final determination no later than 135 days after the date of publication of this preliminary determination.
^{17} See Guangxi Firstpak's Letter, “Firstpak's Request to Postpone Final Determination,” dated April 9, 2025.

U.S. International Trade Commission (ITC) Notification
In accordance with section 733(f) of the Act, Commerce will notify the ITC of its preliminary determination of sales at LTFV. If the final determination is affirmative, the ITC will determine before the later of 120 days after the date of this preliminary determination or 45 days after the final determination whether imports of the subject merchandise are materially injuring, or threaten material injury to, the U.S. industry.

Notification to Interested Parties
This determination is issued and published in accordance with sections 733(f) and 777(i)(1) of the Act, and 19 CFR 351.205(c).
Dated: May 6, 2025.
Christopher Abbott,

Deputy Assistant Secretary for Policy and Negotiations, performing the non-exclusive functions and duties of the Assistant Secretary for Enforcement and Compliance.

Appendix I

Scope of the Investigation
The merchandise subject to this investigation consists of thermoformed molded fiber products regardless of shape, form, function, fiber source, or finish. Thermoformed molded fiber products are formed with cellulose fibers, thermoformed using one or more heated molds, and dried/cured in the mold.
Thermoformed molded fiber products include, but are not limited to, plates, bowls, clamshells, trays, lids, food or foodservice contact packaging, and consumer or other product packaging.
Thermoformed molded fiber products are relatively dense, with a typical fiber density above 0.5 grams per cubic centimeter, and are generally characterized by relatively smooth surfaces. They may be derived from any virgin or recycled cellulose fiber source (including, but not limited to, those sourced from wood, woody crops, agricultural crops/byproducts/residue, and agricultural/industrial/other waste). They may have any weight, shape, dimensionality, design, or size, and may be bleached, unbleached, dyed, colored, or printed. They may include ingredients, additives, or chemistries to enhance functionality including, but not limited to, anti-microbial, anti-fungal, anti-bacterial, heat/flame resistant, hydrophobic, oleophobic, absorbent, or adsorbent. Thermoformed molded fiber products may also be subject to other processing or treatments, including, but not limited to, hot or after pressing, die-cutting, punching, trimming, padding, perforating, printing, labeling, dying, coloring, coating, laminating, embossing, debossing, repacking, or denesting. Thermoformed molded fiber products subject to this investigation may also have additional design features, including, but not limited to, tab closures, venting, channeling, or stiffening.
Thermoformed molded fiber products remain covered by the scope of this investigation if the subject product is encased by exterior packaging. They also remain covered by the scope of this investigation whether imported alone, or in any combination of subject and non-subject merchandise ( e.g., a lid or cover of any type packaged with a molded fiber bowl, addition of any items to make the thermoformed molded fiber packaging suitable for end-use such as absorbent pads). When thermoformed molded fiber products are imported in combination with non-subject merchandise, only the thermoformed molded fiber products are subject merchandise.
Also excluded from the scope of this investigation are products covered by the scope of the antidumping and countervailing duty orders on paper plates from People's Republic of China, the Kingdom of Thailand, and the Socialist Republic of Vietnam.
Excluded from the scope of this investigation are thermoformed molded fiber products imported as packaging material that enclose and/or surround non-subject merchandise prepackaged for final sale upon importation into the United States ( e.g., molded fiber packaging surrounding a cellular phone).
Thermoformed molded fiber products include thermoformed molded fiber products matching the above description that have been finished, packaged, or otherwise processed in a third country by performing finishing, packaging, or processing that would not otherwise remove the merchandise from the scope of the investigation if performed in the country of manufacture of the thermoformed molded fiber products. Examples of finishing, packaging, or other processing in a third country that would not otherwise remove the merchandise from the scope of the investigation if performed in the country of manufacture of the thermoformed molded fiber products include, but are not limited to, hot or after pressing, die-cutting, punching, trimming, padding, perforating, printing, labeling, dying, coloring, coating, laminating, embossing, debossing, repacking, or denesting.
Thermoformed molded fiber products are classified under subheadings 7823.70.0020 and 4823.70.0040, Harmonized Tariff Schedule of the United States (HTSUS). Imports may also be classified under subheadings 4823.61.0020, 4823.61.0040, 4823.69.0020, 4823.69.0040, 4823.90.1000, HTSUS. References to the HTSUS classification are provided for convenience and customs purposes, and the written description of the merchandise under investigation is dispositive.

Appendix II

List of Topics Discussed in the Preliminary Decision Memorandum
I. Summary
II. Background
III. Period of Investigation
IV. Affiliation and Single Entity Treatment
V. Discussion of the Methodology
VI. Adjustment Under Section 777(A)(f) of the Act
VII. Adjustments to Cash Deposit Rates for Export Subsidies in the Companion Countervailing Duty Investigation
VIII. Currency Conversion
IX. Recommendation
DEPARTMENT OF COMMERCE
International Trade Administration
[A-552-845]
Thermoformed Molded Fiber Products From the Socialist Republic of Vietnam: Preliminary Affirmative Determination of Sales at Less Than Fair Value, Postponement of Final Determination and Extension of Provisional Measures

AGENCY:
Enforcement and Compliance, International Trade Administration, Department of Commerce.

SUMMARY:
The U.S. Department of Commerce (Commerce) preliminarily determines that thermoformed molded fiber products from the Socialist Republic of Vietnam (Vietnam) are being, or are likely to be, sold in the United States at less than fair value (LTFV). The period of investigation is April 1, 2024, through September 30, 2024. Interested parties are invited to comment on this preliminary determination.

DATES:
Applicable May 12, 2025.

FOR FURTHER INFORMATION CONTACT:
Zachary Shaykin, AD/CVD Operations, Office IV, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone: (202) 482-2638.

SUPPLEMENTARY INFORMATION:

Background
This preliminary determination is made in accordance with section 733(b) of the Tariff Act of 1930, as amended (the Act). Commerce published the notice of initiation of this investigation on November 4, 2024. ^1 On March 4, 2025, Commerce postponed the preliminary determination of this investigation, and the revised deadline is now May 6, 2025. ^2
^1 See Thermoformed Molded Fiber Products from the People's Republic of China and the Socialist Republic of Vietnam: Initiation of Less-Than-Fair-Value Investigations, 89 FR 87551 (November 4, 2024) ( Initiation Notice ); see also Thermoformed Molded Fiber Products from the People's Republic of China and the Socialist Republic of Vietnam: Initiation of Less-Than-Fair-Value Investigations; Correction, 89 FR 91330 (November 19, 2024).
^2 See Thermoformed Molded Fiber Products from the Socialist Republic of Vietnam: Postponement of Preliminary Determinations of Antidumping Duty Investigations, 90 FR 11153 (March 4, 2025).
For a complete description of the events that followed the initiation of this investigation, see the Preliminary Decision Memorandum. ^3 A list of topics included in the Preliminary Decision Memorandum is included as Appendix II to this notice. The Preliminary Decision Memorandum is a public document and is on file electronically via Enforcement and Compliance's Antidumping and Countervailing Duty Centralized Electronic Service System (ACCESS). ACCESS is available to registered users at https://access.trade.gov. In addition, a complete version of the Preliminary Decision Memorandum can be accessed directly at https://access.trade.gov/public/FRNoticesListLayout.aspx.
^3 See Memorandum, “Decision Memorandum for the Preliminary Affirmative Determination in the Less-Than-Fair-Value Investigation of Thermoformed Molded Fiber Products from the Socialist Republic of Vietnam,” dated concurrently with, and hereby adopted by, this notice (Preliminary Decision Memorandum).

Scope of the Investigation
The product covered by this investigation is thermoformed molded fiber products from Vietnam. For a complete description of the scope of this investigation, see Appendix I.

Scope Comments
In accordance with the Preamble to Commerce's regulations, ^4 the Initiation Notice set aside a period of time for parties to raise issues regarding product coverage (scope). ^5 On November 25, 2024, interested parties submitted comments on the scope of this investigation and, on December 5, 2024, the American Molded Fiber Coalition (the petitioners) responded to these scope comments. ^6 For a summary of the product coverage comments and rebuttal responses submitted to the record for this investigation and accompanying discussion and analysis of all comments timely received, see the Preliminary Scope Decision Memorandum. ^7 Commerce is preliminarily modifying the scope language as it appeared in the Initiation Notice. See the revised scope in Appendix I to this notice.
^4 See Antidumping Duties; Countervailing Duties, Final Rule, 62 FR 27296, 27323 (May 19, 1997) ( Preamble ).
^5 See Initiation Notic e, 89 FR at 87552.
^6 See Eco-Products, PBC's Letter, “Scope Comments,” dated November 25, 2024; see also World Centric's Letter, “World Centric Scope Comments,” dated November 25, 2024; Target General Merchandise, Inc.'s Letter, “Scope Comments on Behalf of Target General Merchandise, Inc.,” dated November 25, 2024; and Petitioners' Letter, “Petitioners' Response to Scope Comments,” dated December 5, 2024.
^7 See Memorandum, “Less-Than-Fair-Value and Countervailing Duty Investigations of Thermoformed Molded Fiber Products from the People's Republic of China and the Socialist Republic of Vietnam: Preliminary Scope Decision Memorandum,” dated concurrently with this notice (Preliminary Scope Decision Memorandum).

Methodology
Commerce is conducting this investigation in accordance with section 731 of the Act. Commerce has calculated export prices in accordance with section 772(a) of the Act. Because Vietnam is a non-market economy (NME), within the meaning of section 771(18) of the Act, Commerce has calculated normal value in accordance with section 773(c) of the Act. In addition, Commerce has relied on partial adverse facts available under sections 776(a) and (b) of the Act for Vietnam Yuzhan Packaging Technology Company Limited (Yuzhan). For a full description of the methodology underlying Commerce's preliminary determination, see the Preliminary Decision Memorandum.

Combination Rates
In the Initiation Notice, ^8 Commerce stated that it would calculate producer/exporter combination rates for the respondents that are eligible for a separate rate in this investigation. Policy Bulletin 05.1 describes this practice. ^9
^8 See Initiation Notice, 89 FR at 87554-87555.
^9 See Enforcement and Compliance's Policy Bulletin No. 05.1, regarding, “Separate-Rates Practice and Application of Combination Rates in Antidumping Investigations involving Non-Market Economy Countries,” (April 5, 2005) (Policy Bulletin 05.1), available on Commerce's website at https://enforcement.trade.gov/policy/bull05-1.pdf.

Separate Rates
We preliminarily granted a separate rate to a certain respondent that we did not select for individual examination. ^{10} In calculating the rate for non-individually examined separate rate respondents in an NME LTFV investigation, Commerce normally looks to section 735(c)(5)(A) of the Act, which pertains to the calculation of the all-others rate in a market economy LTFV investigation, for guidance. Pursuant to section 735(c)(5)(A) of the Act, normally this rate shall be an amount equal to the weighted average of the estimated weighted-average dumping margins those companies individually examined, excluding any margins that are zero, de minimis, or based entirely under section 776 of the Act.
^{10} See Preliminary Decision Memorandum for additional details.
In this investigation, Commerce calculated an individual estimated weighted-average dumping margin for Yuzhan that is not zero, de minimis, or based entirely on facts otherwise available. Therefore, we are preliminarily determining the dumping margin for the non-examined, separate rate company based on the calculated rate of the sole mandatory respondent, Yuzhan, in accordance with section 735(c)(5)(A) of the Act. See the table below in the “Preliminary Determination” section of this notice.

Preliminary Determination
Commerce preliminarily determines that the following estimated weighted-average dumping margins exist:
^{11} The companies that will receive the Vietnam-wide rate because they did not respond to Commerce's quantity and value questionnaire and/or provide a separate rate application are: (1) HC Packaging Asia (Industrial Park); (2) Honha Eco Pulp Viet Nam Paper Tray; (3) Pulp Tray, Martin Vietnam Co. Ltd.; (4) Vietnam Yuhua Packaging Technology Co., Ltd.; (5) Zhong Xin Ya Tai Viet Nam Co., Ltd.; and (6) Cong Ty TNHH Cong Nghe Bao Bi Yuzhan.
Producer | Exporter | Estimated weighted- average dumping margin (percent) | Cash deposit rate (adjusted for Subsidy Offsets) (percent)
Vietnam Yuzhan Packaging Technology Company Limited | Vietnam Yuzhan Packaging Technology Company Limited | 3.86 | 0.76
Ningbo Changya Plastic (Vietnam) Co., Ltd | Ningbo Changya Plastic (Vietnam) Co., Ltd | 3.86 | 0.76
Ningbo Changya Plastic (Vietnam) Co., Ltd | Changya Newmaterial Technology Co., Ltd | 3.86 | 0.76
Vietnam-Wide Entity ^{11} | * 260.56 | 211.60
* This rate is based on facts available with adverse inferences.

Suspension of Liquidation
In accordance with section 733(d)(2) of the Act, Commerce will direct U.S. Customs and Border Protection (CBP) to suspend liquidation of subject merchandise as described in the scope of the investigation section entered, or withdrawn from warehouse, for consumption on or after the date of publication of this notice in the Federal Register , as discussed below. Further, pursuant to section 733(d)(1)(B) of the Act and 19 CFR 351.205(d), Commerce will instruct CBP to require a cash deposit equal to the weighted average amount by which normal value exceeds U.S. price, as indicated in the chart above as follows: (1) for the producer/exporter combinations listed in the table above, the cash deposit rate is equal to the estimated weighted-average dumping margin listed for that combination in the table; (2) for all combinations of Vietnamese producers/exporters of merchandise under consideration that have not established eligibility for their own separate rates, the cash deposit rate will be equal to the estimated weighted-average dumping margin established for the Vietnam-wide entity; and (3) for all third-county exporters of merchandise under consideration not listed in the table above, the cash deposit rate is the cash deposit rate applicable to the Vietnamese producer/exporter combination (or the Vietnam-wide entity) that supplied that third-country exporter.
Should the final estimated weighted-average dumping margin be zero or de minimis for the producer/exporter combinations identified above, entries of merchandise from these producer/exporter combinations will be excluded from the order. Such exclusion(s) will not be applicable to merchandise exported to the United States by any other producer/exporter combinations or by third-country exporters that sourced from the excluded producer/exporter combination(s).
To determine the cash deposit rate, Commerce normally adjusts the estimated weighted-average dumping margin by the amount of domestic subsidy pass-through and export subsidies determined in a companion countervailing duty (CVD) proceeding when CVD provisional measures are in effect. Accordingly, where Commerce has made a preliminary affirmative determination for domestic subsidy pass-through or export subsidies, Commerce has offset the calculated estimated weighted-average dumping margin by the appropriate rate(s). Any such adjusted rates may be found in the “Preliminary Determination” section's chart of estimated weighted-average dumping margins, above.
Should provisional measures in the companion CVD investigation expire prior to the expiration of provisional measures in this LTFV investigation, Commerce will direct CBP to begin collecting cash deposits at a rate equal to the estimated weighted-average dumping margins calculated in this preliminary determination unadjusted for the passed-through domestic subsidies or for export subsidies at the time the CVD provisional measures expire.
These suspension of liquidation instructions will remain in effect until further notice.

Disclosure
Commerce intends to disclose to interested parties the calculations performed in connection with this preliminary determination within five days of its public announcement or, if there is no public announcement, within five days of the date of publication of this notice in accordance with 19 CFR 351.224(b).
Consistent with 19 CFR 351.224(e), Commerce will analyze and, if appropriate, correct any timely allegations of significant ministerial errors by amending the preliminary determination. However, consistent with 19 CFR 351.224(d), Commerce will not consider incomplete allegations that do not address the significance standard under 19 CFR 351.224(g) following the preliminary determination. Instead, Commerce will address such allegations in the final determination together with issues raised in the case briefs or other written comments.

Verification
As provided in section 782(i)(1) of the Act, Commerce intends to verify information relied upon in making its final determination.

Public Comment
All interested parties are invited to comment on Commerce's Preliminary Scope Decision Memorandum in scope case and scope rebuttal briefs. The deadline for interested parties to submit scope case briefs is 30 days after the issuance of the Preliminary Scope Decision Memorandum. Scope rebuttal briefs, limited to issues raised in the scope case briefs, may be submitted no later than seven days after the deadline for the scope case briefs. Scope case and rebuttal briefs must be filed simultaneously, via ACCESS, on the records of the LTFV and CVD investigations of thermoformed molded fiber products from the People's Republic of China and Vietnam.
Case briefs or other written comments, excluding scope comments, may be submitted to the Assistant Secretary for Enforcement and Compliance no later than seven days after the date on which the last final verification report is issued in this investigation. ^{12} A timeline for the submission of case briefs and written comments will be provided to interested parties at a later date. Rebuttal briefs, limited to issues raised in the case briefs, may be filed not later than five days after the date for filing case briefs. ^{13} Interested parties who submit case or rebuttal briefs in this proceeding must submit: (1) a table of contents listing each issue; and (2) a table of authorities. ^{14}
^{12} See 19 CFR 351.309(c)(1)(i); see also 19 CFR 351.303 (for general filing requirements).
^{13} See 19 CFR 351.309(d); see also Administrative Protective Order, Service, and Other Procedures in Antidumping and Countervailing Duty Proceedings, 88 FR 67069, 67077 (September 29, 2023) ( APO and Service Final Rule ).
^{14} See 19 CFR 351.309(c)(2) and (d)(2).
As provided under 19 CFR 351.309(c)(2) and (d)(2), in prior proceedings we have encouraged interested parties to provide an executive summary of their brief that should be limited to five pages total, including footnotes. In this investigation, we instead request that interested parties provide at the beginning of their briefs a public, executive summary for each issue raised in their briefs. ^{15} Further, we request that interested parties limit their executive summary of each issue to no more than 450 words, not including citations. We intend to use the executive summaries as the basis of the comment summaries included in the issues and decision memorandum that will accompany the final determination in this investigation. We request that interested parties include footnotes for relevant citations in the executive summary of each issue. Note that Commerce has amended certain of its requirements pertaining to the service of documents in 19 CFR 351.303(f). ^{16}
^{15} We use the term “issue” here to describe an argument that Commerce would normally address in a comment of the Issues and Decision Memorandum.
^{16} See APO and Service Final Rule, 88 FR at 67077.
Pursuant to 19 CFR 351.310(c), interested parties who wish to request a hearing, limited to issues raised in the case and rebuttal briefs, must submit a written request to the Assistant Secretary for Enforcement and Compliance, U.S. Department of Commerce, within 30 days after the date of publication of this notice. Requests should contain (1) the party's name, address, and telephone number; (2) the number of participants and whether any participant is a foreign national; and (3) a list of the issues to be discussed. If a request for a hearing is made, Commerce intends to hold the hearing at a time and date to be determined.

Postponement of Final Determination and Extension of Provisional Measures
Section 735(a)(2) of the Act provides that a final determination may be postponed until not later than 135 days after the date of the publication of the preliminary determination if, in the event of an affirmative preliminary determination, a request for such postponement is made by exporters who account for a significant proportion of exports of the subject merchandise, or in the event of a negative preliminary determination, a request for such postponement is made by the petitioners. Pursuant to 19 CFR 351.210(e)(2), Commerce requires that requests by respondents for postponement of a final antidumping determination be accompanied by a request for extension of provisional measures from a four-month period to a period not more than six months in duration.
On May 1, 2025, pursuant to 19 CFR 351.210(e), Yuzhan requested that Commerce postpone the final determination and that provisional measures be extended to a period not to exceed six months. ^{17} In accordance with section 735(a)(2)(A) of the Act and 19 CFR 351.210(b)(2)(ii), because: (1) the preliminary determination is affirmative; (2) the requesting exporter accounts for a significant proportion of exports of the subject merchandise; and (3) no compelling reasons for denial exist, Commerce is postponing the final determination and extending the provisional measures from a four-month period to a period not greater than six months. Accordingly, Commerce will make its final determination no later than 135 days after the date of publication of this preliminary determination.
^{17} See Yuzhan's Letter, “Thermoformed Molded Fiber Products from the Socialist Republic of Vietnam: Request to Extend Final Determination,” dated May, 1, 2025.

U.S. International Trade Commission (ITC) Notification
In accordance with section 733(f) of the Act, Commerce will notify the ITC of its preliminary determination of sales at LTFV. If the final determination is affirmative, the ITC will determine before the later of 120 days after the date of this preliminary determination or 45 days after the final determination whether imports of the subject merchandise are materially injuring, or threaten material injury to, the U.S. industry.

Notification to Interested Parties
This determination is issued and published in accordance with sections 733(f) and 777(i)(1) of the Act, and 19 CFR 351.205(c).
Dated: May 6, 2025.
Christopher Abbott,

Deputy Assistant Secretary for Policy and Negotiations, performing the non-exclusive functions and duties of the Assistant Secretary for Enforcement and Compliance.

Appendix I

Scope of the Investigation
The merchandise subject to this investigation consists of thermoformed molded fiber products regardless of shape, form, function, fiber source, or finish. Thermoformed molded fiber products are formed with cellulose fibers, thermoformed using one or more heated molds, and dried/cured in the mold.
Thermoformed molded fiber products include, but are not limited to, plates, bowls, clamshells, trays, lids, food or foodservice contact packaging, and consumer or other product packaging.
Thermoformed molded fiber products are relatively dense, with a typical fiber density above 0.5 grams per cubic centimeter, and are generally characterized by relatively smooth surfaces. They may be derived from any virgin or recycled cellulose fiber source (including, but not limited to, those sourced from wood, woody crops, agricultural crops/byproducts/residue, and agricultural/industrial/other waste). They may have any weight, shape, dimensionality, design, or size, and may be bleached, unbleached, dyed, colored, or printed. They may include ingredients, additives, or chemistries to enhance functionality including, but not limited to, anti-microbial, anti-fungal, anti-bacterial, heat/flame resistant, hydrophobic, oleophobic, absorbent, or adsorbent. Thermoformed molded fiber products may also be subject to other processing or treatments, including, but not limited to, hot or after pressing, die-cutting, punching, trimming, padding, perforating, printing, labeling, dying, coloring, coating, laminating, embossing, debossing, repacking, or denesting. Thermoformed molded fiber products subject to this investigation may also have additional design features, including, but not limited to, tab closures, venting, channeling, or stiffening.
Thermoformed molded fiber products remain covered by the scope of this investigation if the subject product is encased by exterior packaging. They also remain covered by the scope of this investigation whether imported alone, or in any combination of subject and non-subject merchandise ( e.g., a lid or cover of any type packaged with a molded fiber bowl, addition of any items to make the thermoformed molded fiber packaging suitable for end-use such as absorbent pads). When thermoformed molded fiber products are imported in combination with non-subject merchandise, only the thermoformed molded fiber products are subject merchandise.
Also excluded from the scope of this investigation are products covered by the scope of the antidumping and countervailing duty orders on paper plates from People's Republic of China, the Kingdom of Thailand, and the Socialist Republic of Vietnam.
Excluded from the scope of this investigation are thermoformed molded fiber products imported as packaging material that enclose and/or surround non-subject merchandise prepackaged for final sale upon importation into the United States ( e.g., molded fiber packaging surrounding a cellular phone).
Thermoformed molded fiber products include thermoformed molded fiber products matching the above description that have been finished, packaged, or otherwise processed in a third country by performing finishing, packaging, or processing that would not otherwise remove the merchandise from the scope of the investigation if performed in the country of manufacture of the thermoformed molded fiber products. Examples of finishing, packaging, or other processing in a third country that would not otherwise remove the merchandise from the scope of the investigation if performed in the country of manufacture of the thermoformed molded fiber products include, but are not limited to, hot or after pressing, die-cutting, punching, trimming, padding, perforating, printing, labeling, dying, coloring, coating, laminating, embossing, debossing, repacking, or denesting.
Thermoformed molded fiber products are classified under subheadings 7823.70.0020 and 4823.70.0040, Harmonized Tariff Schedule of the United States (HTSUS). Imports may also be classified under subheadings 4823.61.0020, 4823.61.0040, 4823.69.0020, 4823.69.0040, 4823.90.1000, HTSUS. References to the HTSUS classification are provided for convenience and customs purposes, and the written description of the merchandise under investigation is dispositive.

Appendix II

List of Topics Discussed in the Preliminary Decision Memorandum
I. Summary
II. Background
III. Period of Investigation
IV. Discussion of the Methodology
V. Currency Conversion
VI. Adjustment Under Section 777(A)(F) of the Act
VII. Adjustments to Cash Deposit Rates for Export Subsidies in the Companion Countervailing Duty Investigation
VIII. Recommendation
DEPARTMENT OF COMMERCE
National Oceanic and Atmospheric Administration
[RTID 0648-XE838]
Marine Mammals; File No. 23922

AGENCY:
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.

ACTION:
Notice; issuance of permit amendment.

SUMMARY:
Notice is hereby given that the University of California, 35 Medical Center Way, San Francisco, CA 94131, (Responsible Party: Alexander Pollen, Ph.D.) has been issued a minor amendment to Scientific Research Permit No. 23922.

ADDRESSES:
The amendment and related documents are available for review upon written request via email to NMFS.Pr1Comments@noaa.gov.

FOR FURTHER INFORMATION CONTACT:
Shasta McClenahan, Ph.D., or Jennifer Skidmore, (301) 427-8401.

SUPPLEMENTARY INFORMATION:
The requested amendment has been granted under the authority of the Marine Mammal Protection Act of 1972, as amended (16 U.S.C. 1361 et seq. ), the regulations governing the taking and importing of marine mammals (50 CFR part 216), the Endangered Species Act of 1973, as amended (ESA; 16 U.S.C. 1531 et seq. ), and the regulations governing the taking, importing, and exporting of endangered and threatened species (50 CFR parts 222-226).
The original permit (No. 23922), issued on July 27, 2020 (85 FR 48508, August 11, 2020) authorized the receipt, import, and export of cetacean parts to develop cell lines and study development for evolutionary neuroscience and toxicology studies through July 31, 2025. The minor amendment, issued on May 6, 2025, extends the duration of the permit through July 31, 2026, but does not change any other terms or conditions of the permit.
Dated: May 7, 2025.
Kimberly Damon-Randall,

Director, Office of Protected Resources, National Marine Fisheries Service.
DEPARTMENT OF COMMERCE
National Oceanic and Atmospheric Administration
[RTID 0648-XE894]
Endangered and Threatened Species; Take of Anadromous Fish

AGENCY:
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Department of Commerce.

ACTION:
Notice; availability of a Proposed Evaluation and Pending Determination for public comment.

SUMMARY:
Notice is hereby given that NMFS has received plans for twelve hatchery programs rearing and releasing Chinook salmon in the Nooksack River basin and Strait of Georgia. The plans describe hatchery programs operated by the Lummi Nation and Washington Department of Fish and Wildlife (WDFW) in collaboration with the Nooksack Indian Tribe as co-managers. This document serves to notify the public of the availability and opportunity to comment on a Proposed Evaluation and Determination Documents (PEPD) on the proposed hatchery programs.

DATES:
Comments must be received at the appropriate address (see ADDRESSES ) no later than 5 p.m. Pacific time on June 11, 2025. Comments received after this date may not be considered.

ADDRESSES:
Comments may be submitted by email. The mailbox address for providing email comments is: Hatcheries.Public.Comment@noaa.gov. Include in the subject line of the email comment the following identifier: Comments on Nooksack River hatchery programs. The document available for public comment is available on the internet at https://www.fisheries.noaa.gov/action/twelve-hatchery-and-genetic-management-plans-nooksack-river-basin-and-georgia-strait-salmon.

FOR FURTHER INFORMATION CONTACT:
Morgan Robinson at (253) 307-2670 or by email at morgan.robinson@noaa.gov.

SUPPLEMENTARY INFORMATION:

ESA-Listed Species Covered in This Notice
• Puget Sound Chinook salmon ( Oncorhynchus tshawytscha ): threatened, naturally and artificially propagated;
• Puget Sound Steelhead ( O. mykiss ): threatened, naturally and artificially propagated.

Background
The term “take” is defined under the Endangered Species Act (ESA) to mean harass, harm, pursue, hunt, shoot, wound, kill, trap, capture, or collect, or to attempt to engage in any such conduct. The ESA prohibits the take of endangered salmonids and, pursuant to ESA section 4(d), ESA regulations can be extended to prohibit the take of threatened salmonids. However, NMFS may make exceptions to the take prohibitions for hatchery programs that are approved by NMFS under the limits on the prohibitions outlined in 50 CFR 223.203(b). The operators, Lummi Nation and WDFW, collaborating with tribal co-manager Nooksack Indian Tribe, have submitted twelve HGMPs to NMFS pursuant to NMFS' limit six of the 4(d) Rule of the ESA for hatchery activities in the Nooksack River basin and Strait of Georgia, Washington. Chinook, coho, and chum salmon hatchery programs will be operated at Skookum Creek, Kendall Creek, Samish, Glenwood Springs, Whatcom Creek, and Lummi Bay hatcheries.
The hatchery programs are designed to contribute to the survival and recovery of Nooksack River Chinook salmon and provide salmon for harvest augmentation purposes. These hatchery programs are intended to contribute to fulfilling federal tribal treaty rights affirmed in U.S. v. Washington (1974) by enhancing future fishing opportunities for Chinook, coho, and chum salmon. Included in the hatchery plans are research and monitoring activities to study the effect of the programs on the recovery of Puget Sound Chinook salmon and steelhead.
Authority: 16 U.S.C. 1531 et seq.; 16 U.S.C. 742a et seq.
Dated: May 7, 2025.
Kimberly Damon-Randall,

Director, Office of Protected Resources, National Marine Fisheries Service.
DEPARTMENT OF EDUCATION
Application Deadline for Fiscal Year 2025; Small, Rural School Achievement Program

AGENCY:
Office of Elementary and Secondary Education, Department of Education.

ACTION:
Notice.

SUMMARY:
Under the Small, Rural School Achievement (SRSA) program, the U.S. Department of Education (Department) awards grants on a formula basis to eligible local educational agencies (LEAs) to address the unique needs of rural school districts. In this notice, we establish the deadline and describe the application process for the fiscal year (FY) 2025 SRSA grant.
All LEAs eligible for FY 2025 SRSA funds must apply electronically via the process described in this notice by the deadline listed below.

DATES:
Applications Available: May 14, 2025.
Deadline for Transmittal of Applications: June 13, 2025.
Application Technical Assistance: The Department will announce via email application technical assistance opportunities for applicants when the application becomes available.

FOR FURTHER INFORMATION CONTACT:
Leslie Poynter, Rural Education Achievement Program (REAP) Group Leader, U.S. Department of Education, 400 Maryland Avenue SW, Washington, DC 20202. Telephone: (202) 401-0039. Email: reap@ed.gov .
If you are deaf, hard of hearing, or have a speech disability and wish to access telecommunications relay services, please dial 7-1-1.

SUPPLEMENTARY INFORMATION:
Assistance Listing Number: 84.358A.
OMB Control Number: 1810-0646.

I. Award Information
Type of Award: Formula grant.
Available Funds: $110,000,000.
Estimated Range of Awards: $0-$60,000.
Note: The amount of an LEA's award depends on the number and makeup of eligible LEAs that complete the SRSA application, and the amount Congress appropriates for the program. Some eligible LEAs may receive an SRSA allocation of $0 due to the statutory funding formula and, in that case, will not be invited to submit an application.
Estimated Number of Awards: 4,200.

II. Program Authority and Eligibility Information

Under what statutory authority will FY 2025 SRSA grant awards be made?
The FY 2025 SRSA grant awards will be made under title V, part B, subpart 1 of the Elementary and Secondary Education Act of 1965 (ESEA), 20 U.S.C. 7345-7345a.

Which LEAs are eligible for an award under the SRSA program?
For FY 2025, an LEA (including a public charter school that meets the definition of LEA in section 8101(30) of the ESEA) is eligible for an award under the SRSA program if it meets both of the criteria below:
(a) The total number of students in average daily attendance at all of the schools served by the LEA is fewer than 600, or each county in which a school served by the LEA is located has a total population density of fewer than 10 persons per square mile; and
(b) All of the schools served by the LEA are designated with a school locale code of 41, 42, or 43 by the Department's National Center for Education Statistics (NCES), or the Secretary has determined, based on a demonstration by the LEA and concurrence of the State educational agency, that the LEA is located in an area defined as rural by a governmental agency of the State.
The Department provides an eligibility spreadsheet listing each LEA eligible to apply for FY 2025 SRSA grant funds. The spreadsheet is available on the Department's website at: https://data.ed.gov/dataset/reap-fy-2025-master-eligibility-spreadsheet/resources .
If an LEA on the Department's list of LEAs eligible to apply for an FY 2025 SRSA award will close prior to the 2025-2026 school year, that LEA is not eligible to receive an FY 2025 SRSA award and should not apply.
Note: The “Choice of Participation” provision under section 5225 of the ESEA gives an LEA eligible for both SRSA and the Rural and Low-Income School (RLIS) program, which is authorized under title V, part B, subpart 2 of the ESEA, the option to participate in either the SRSA program or the RLIS program. 20 U.S.C. 7351d. An LEA eligible for both SRSA and RLIS is henceforth referred to as a “dual-eligible LEA.”

Which eligible LEAs must submit an application to receive an FY 2025 SRSA grant award?
Under 34 CFR 75.104(a), the Secretary makes a grant only to an eligible entity that submits an application.
In FY 2025, each LEA eligible to receive an SRSA award is required to submit an SRSA application in order to receive SRSA funds, regardless of whether the LEA received an award or submitted an application in a previous year. For example, if a rural community has two distinct LEAs—one composed of its elementary school(s) and one composed of its high school(s)—each distinct LEA must submit its own SRSA application. This requirement applies to all eligible LEAs, including each dual-eligible LEA that chooses to participate in the SRSA program instead of the RLIS program and each SRSA-eligible LEA that is a member of an educational service agency (ESA) that does not receive SRSA funds on the LEA's behalf. In the case of an SRSA-eligible LEA that is a member of an SRSA-eligible ESA, the LEA and ESA must coordinate directly with each other to determine which entity will submit an SRSA application on the LEA's behalf, as both entities may not apply for or receive SRSA funds for the LEA. As noted above, pursuant to section 5225 of the ESEA, a dual-eligible LEA that applies for SRSA funds will not receive an RLIS award.

What are the Unique Entity Identification (UEI) number requirements for the SRSA program?
As required by 2 CFR part 25, Appendix A, entities receiving funds from the Federal government, including SRSA-eligible LEAs that apply for an SRSA award, must maintain current entity information in the System for Award Management (SAM). SAM is the Federal government's primary registrant database and is managed by the General Services Administration, not the Department. The UEI, a 12-character alphanumeric code, is the primary means of entity identification for Federal awards.
Each SRSA-eligible LEA must provide its UEI on the SRSA application. An LEA must have a UEI with an active registration status in SAM to access its awarded SRSA grant funds. An LEA without a UEI may not receive an SRSA award until it has obtained and registered a UEI. Obtaining a UEI is free to LEAs and can be accomplished at www.SAM.gov. LEAs may find SAM's guide helpful in understanding the registration process, available at: https://sam.gov/content/entity-registration. For additional resources or technical support related to the UEI registration process please utilize the support features at www.fsd.gov.

III. Application and Submission Information

Electronic Submission of Applications Using Connect.gov
The Department will send an email with a unique application link on May 14, 2025, to each LEA that is eligible and estimated to receive a positive allocation ( i.e., an estimated amount greater than $0.00) for an FY 2025 SRSA grant award. The email will include detailed instructions for completing the electronic application.
An eligible LEA must submit an electronic application via Connect.gov by June 13, 2025, to be assured of receiving an FY 2025 SRSA grant award. The Department may consider applications submitted after the deadline to the extent practicable and contingent upon the availability of funding.
Please note the following:
• The application is estimated to take 30 minutes to complete. LEAs are encouraged not to wait until the application deadline date to begin the application process.
• Eligible LEAs will receive periodic emails during the application period containing a reminder to complete the SRSA application prior to the June 13, 2025, deadline.
• An application received by Connect.gov is dated and time stamped upon submission, and an applicant will receive a confirmation email after the application is submitted.
• If any applicant information changes ( e.g., address or contact information for the LEA) after an application has been submitted via Connect.gov, the applicant must contact the Department directly by emailing reap@ed.gov to update such information.

Application Deadline Date Extension in Case of Technical Issues
If you are unable to submit an application by June 13, 2025, because of technical issues, contact the Department by emailing reap@ed.gov within 5 business days and provide an explanation of the technical problem you experienced. The late application will be accepted as having met the deadline if the Department can confirm that a technical issue occurred with the Connect.gov system that affected your ability to submit the application by the deadline. As noted above, if you submit the application after the deadline and the late submission is not due to a technical issue about which you have notified the Department, the Department may consider your application to the extent practicable and contingent upon the availability of funding.

IV. Other Procedural Requirements

System for Award Management (SAM)
To do business with the Department, an entity must maintain an active registration in the SAM, the Federal Government's primary registrant database, using the following information:
a. UEI.
b. Legal business name.
c. Physical address associated with the UEI.
d. Taxpayer identification number (TIN).
e. Taxpayer name associated with the TIN.
f. Bank information to set up Electronic Funds Transfer (EFT) ( i.e., routing number, account number, and account type (checking/savings)).

V. Accessibility Information and Program Authority
Accessible Format: Upon request to the REAP Group Leader (using the email or phone number provided in the FOR FURTHER INFORMATION CONTACT section above), individuals with disabilities can obtain this document and a copy of the application package in an accessible format. The Department will provide the requestor with an accessible format that may include Rich Text Format (RTF) or text format (txt), a thumb drive, an MP3 file, braille, large print, audiotape, compact disc, or other accessible format.
Electronic Access to This Document: The official version of this document is the document published in the Federal Register . You may access the official edition of the Federal Register and the Code of Federal Regulations at https://www.govinfo.gov/. At this site you can view this document, as well as all other Department documents published in the Federal Register , in text or Portable Document Format (PDF). To use PDF, you must have Adobe Acrobat Reader, which is available free at the site.
You may also access Department documents published in the Federal Register by using the article search feature at www.federalregister.gov. Specifically, through the advanced search feature at this site, you can limit your search to documents published by the Department.
Program Authority: Sections 5211-5212 of the ESEA, 20 U.S.C. 7345-7345a.
Hayley B. Sanon,

Principal Deputy Assistant Secretary and Acting Assistant Secretary, Office of Elementary and Secondary Education.
DEPARTMENT OF ENERGY
Federal Energy Regulatory Commission
[Project No. 3633-044]
KC Brighton, LLC; Notice of Availability of Environmental Assessment
In accordance with the National Environmental Policy Act of 1969 and the Federal Energy Regulatory Commission's (Commission or FERC) regulations, 18 CFR part 380, Commission staff reviewed KC Brighton LLC's application for surrender of license for the Brighton Hydroelectric Project No. 3633 and have prepared an Environmental Assessment (EA) for the project. ^1 The licensee proposes to surrender its license and decommission the project. The project is located on the Patuxent River in Howard and Montgomery counties, Maryland. The project does not occupy any federal lands.
^1 The unique identification number for documents relating to this environmental review is EAXX-019-20-000-1736780205.
The EA contains Commission staff's analysis of the potential environmental effects of the proposed surrender, alternatives to the proposed action, and concludes that the proposed surrender would not constitute a major federal action that would significantly affect the quality of the human environment.
The EA may be viewed on the Commission's website at http://www.ferc.gov using the “eLibrary” link. Enter the docket number (P-3633) in the docket number field to access the document. For assistance, contact FERC Online Support at FERCOnlineSupport@ferc.gov or toll-free at 1-866-208-3676, or for TTY, (202) 502-8659.
You may also register online at http://www.ferc.gov/docs-filing/esubscription.asp to be notified via email of new filings and issuances related to this or other pending projects. For assistance, contact FERC Online Support.
All comments must be filed by June 11, 2025.
The Commission strongly encourages electronic filing. Please file comments using the Commission's eFiling system at http://www.ferc.gov/docs-filing/efiling.asp . Commenters can submit brief comments up to 6,000 characters, without prior registration, using the eComment system at http://www.ferc.gov/docs-filing/ecomment.asp . For assistance, please contact FERC Online Support. In lieu of electronic filing, you may submit a paper copy. Submissions sent via the U.S. Postal Service must be addressed to: Debbie-Anne A. Reese, Secretary, Federal Energy Regulatory Commission, 888 First Street NE, Room 1A, Washington, DC 20426. Submissions sent via any other carrier must be addressed to: Debbie-Anne A. Reese, Secretary, Federal Energy Regulatory Commission, 12225 Wilkins Avenue, Rockville, Maryland 20852. The first page of any filing should include docket number P-3633-044.
The Commission's Office of Public Participation (OPP) supports meaningful public engagement and participation in Commission proceedings. OPP can help members of the public, including landowners, Tribal members, and others access publicly available information and navigate Commission processes. For public inquiries and assistance with making filings such as interventions, comments, or requests for rehearing, the public is encouraged to contact OPP at (202) 502-6595 or OPP@ferc.gov .
For further information, contact Kelly Fitzpatrick at 202-502-8435 or kelly.fitzpatrick@ferc.gov .
Dated: May 6, 2025.
Debbie-Anne A. Reese,

Secretary.
DEPARTMENT OF ENERGY
Federal Energy Regulatory Commission
Combined Notice of Filings #2
Take notice that the Commission received the following electric corporate filings:
Docket Numbers: EC25-85-000.
Applicants: Icetec Energy Services, Inc., Icetec.com, Inc., Veolia Energy North America Holdings, Inc.
Description: Application for Authorization Under Section 203 of the Federal Power Act of Icetec.com, Inc.
Filed Date: 5/2/25.
Accession Number: 20250502-5229.
Comment Date: 5 p.m. ET 5/23/25.
Take notice that the Commission received the following electric rate filings:
Docket Numbers: ER13-738-013; ER11-3097-017; ER10-1186-016; ER12-421-007; ER11-2731-007.
Applicants: Heritage Stoney Corners Wind Farm I, LLC, Heritage Garden Wind Farm I, LLC, DTE Energy Supply, LLC, DTE Energy Trading, Inc., DTE Electric Company.
Description: Notice of Change in Status of DTE Electric Company, et al.
Filed Date: 4/29/25.
Accession Number: 20250429-5384.
Comment Date: 5 p.m. ET 5/20/25.
Docket Numbers: ER17-256-022; ER17-242-021; ER17-243-021; ER17-245-021; ER17-652-021.
Applicants: Lightstone Marketing LLC, Waterford Power, LLC, Lawrenceburg Power, LLC, Gavin Power, LLC, Darby Power, LLC.
Description: Notice of Non-Material Change in Status of Darby Power, LLC, et al.
Filed Date: 4/30/25.
Accession Number: 20250430-5694.
Comment Date: 5 p.m. ET 5/21/25.
Docket Numbers: ER25-2151-000.
Applicants: PJM Interconnection, L.L.C.
Description: § 205(d) Rate Filing: Original GIA Service Agreement No. 7645; Project Identifier No. AC2-123/AE2-326 to be effective 4/4/2025.
Filed Date: 5/5/25.
Accession Number: 20250505-5038.
Comment Date: 5 p.m. ET 5/27/25.
Docket Numbers: ER25-2152-000.
Applicants: PJM Interconnection, L.L.C.
Description: § 205(d) Rate Filing: Original GIA, Service Agreement No. 7648; Project Identifier No. AE1-173 to be effective 4/2/2025.
Filed Date: 5/5/25.
Accession Number: 20250505-5039.
Comment Date: 5 p.m. ET 5/27/25.
Docket Numbers: ER25-2153-000.
Applicants: PJM Interconnection, L.L.C.
Description: § 205(d) Rate Filing: Original GIA, Service Agreement No. 7655; AG1-152 to be effective 4/3/2025.
Filed Date: 5/5/25.
Accession Number: 20250505-5067.
Comment Date: 5 p.m. ET 5/27/25.
Docket Numbers: ER25-2154-000.
Applicants: PJM Interconnection, L.L.C.
Description: § 205(d) Rate Filing: Amendment to Service Agreement No. 5849; Queue Position No. AE2-131 to be effective 7/5/2025.
Filed Date: 5/5/25.
Accession Number: 20250505-5069.
Comment Date: 5 p.m. ET 5/27/25.
Docket Numbers: ER25-2155-000.
Applicants: PJM Interconnection, L.L.C.
Description: § 205(d) Rate Filing: Amendment to GIA, SA No. 7403; PJM Project Identifier No. AF2-229 to be effective 7/5/2025.
Filed Date: 5/5/25.
Accession Number: 20250505-5105.
Comment Date: 5 p.m. ET 5/27/25.
Docket Numbers: ER25-2156-000.
Applicants: Cascade BESS LLC.
Description: § 205(d) Rate Filing: Notice of Succession to be effective 4/30/2025.
Filed Date: 5/5/25.
Accession Number: 20250505-5180.
Comment Date: 5 p.m. ET 5/27/25.
The filings are accessible in the Commission's eLibrary system ( https://elibrary.ferc.gov/idmws/search/fercgensearch.asp ) by querying the docket number.
Any person desiring to intervene, to protest, or to answer a complaint in any of the above proceedings must file in accordance with Rules 211, 214, or 206 of the Commission's Regulations (18 CFR 385.211, 385.214, or 385.206) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.
eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call (866) 208-3676 (toll free). For TTY, call (202) 502-8659.
The Commission's Office of Public Participation (OPP) supports meaningful public engagement and participation in Commission proceedings. OPP can help members of the public, including landowners, community organization, Tribal members and others, access publicly available information and navigate Commission processes. For public inquiries and assistance with making filings such as interventions, comments, or requests for rehearing, the public is encouraged to contact OPP at (202) 502-6595 or OPP@ferc.gov.
Dated: May 5, 2025.
Carlos D. Clay,

Deputy Secretary.
DEPARTMENT OF ENERGY
Federal Energy Regulatory Commission
Notice of Effectiveness of Exempt Wholesale Generator Status
| Docket Nos.
Peyton Creek Wind Farm II, LLC | EG25-96-000
Stoneridge Solar, LLC | EG25-97-000
Sun Ridge Solar, LLC | EG25-98-000
Regis Falfurrias LLC | EG25-99-000
Regis Medina LLC | EG25-100-000
Regis Sinton Pirate LLC | EG25-101-000
Regis Carrizo Springs LLC | EG25-102-000
Regis Escondido LLC | EG25-103-000
Regis Gears-Harris LLC | EG25-104-000
Regis Goodwin LLC | EG25-105-000
Regis Gregory LLC | EG25-106-000
Regis Hearn LLC | EG25-107-000
Regis Hidden Valley LLC | EG25-108-000
Regis Laureles LLC | EG25-109-000
Regis Leakey LLC | EG25-110-000
Regis Lyssy LLC | EG25-111-000
Regis Mason LLC | EG25-112-000
Regis Medina Lake LLC | EG25-113-000
Regis Milton LLC | EG25-114-000
Regis Monte Cristo LLC | EG25-115-000
Regis Muenster LLC | EG25-116-000
Regis Palacios LLC | EG25-117-000
Regis Utopia LLC | EG25-118-000
La Casa Wind, LLC | EG25-119-000
Carol Renewable Energy, LLC | EG25-120-000
Throckmorton Wind, LLC | EG25-121-000
Willow Creek Wind Project, LLC | EG25-123-000
Salt Creek Wind, LLC | EG25-124-000
Regis Continental LLC | EG25-125-000
Golden Fields Solar IV Bess LLC | EG25-126-000
Hornshadow Solar, LLC | EG25-127-000
Hornshadow Solar 2, LLC | EG25-128-000
Breckinridge Wind, LLC | EG25-129-000
EXUS NM Data Center IV, LLC | EG25-130-000
Cedar Bluff Wind Energy, LLC | EG25-131-000
Mammoth Plains Wind, LLC | EG25-132-000
Seiling Wind Energy II, LLC | EG25-133-000
Palo Duro Wind, LLC | EG25-134-000
Calistoga Resiliency Center, LLC | EG25-135-000
New Madrid Solar, LLC | EG25-136-000
Forgeview Solar, LLC | EG25-137-000
Gibson Solar, LLC | EG25-138-000
Lane City Wind, LLC | EG25-139-000
BHS Solar, LLC | EG25-140-000
Flat Fork Solar, LLC | EG25-141-000
Bronson Solar, LLC | EG25-142-000
Wildwood Solar, LLC | EG25-143-000
Sebree Solar, LLC | EG25-144-000
Route 66 Energy Storage, LLC | EG25-145-000
Sky Ranch Energy Storage II, LLC | EG25-146-000
Fremont Solar, LLC | EG25-147-000
BT Hickerson Solar, LLC | EG25-148-000
Compadre Solar, LLC | EG25-149-000
Blue Summit II Storage, LLC | EG25-150-000
Diver Solar, LLC | EG25-151-000
Roadrunner Crossing Energy Storage, LLC | EG25-152-000
Milagro Solar I, LLC | EG25-153-000
Dominguez Grid, LLC | EG25-154-000
MPH Elwood, LLC | EG25-155-000
Tibbits Energy Storage LLC | EG25-156-000
Skeleton Creek Energy Center, LLC | EG25-157-000
Cadence Solar Energy LLC | EG25-158-000
Trade Post Solar LLC | EG25-159-000
Roaring Springs Solar, LLC | EG25-160-000
Midpoint Solar, LLC | EG25-161-000
1000 Mile Solar, LLC | EG25-162-000
Sequoia Renewables LLC | EG25-163-000
Luna Valley Storage LLC | EG25-164-000
Luna Valley Solar I, LLC | EG25-165-000
Dogfish ESS Assets, LLC | EG25-166-000
Osagrove Flats Wind, LLC | EG25-167-000
Dusty Rose Wind, LLC | EG25-168-000
Hart Wind Project, LLC | EG25-169-000
CPV Rogue's Wind, LLC | EG25-170-000
Cottonwood Bayou Storage, LLC | EG25-171-000
Knox County Wind Farm LLC | EG25-172-000
Carousel Wind, LLC | EG25-173-000
Monarch Creek Wind LLC | EG25-174-000
Eldorado Solar Project II, LLC | EG25-175-000
Sol InfraCo MT3, LLC | EG25-176-000
FRP Forest Trail Solar, LLC | EG25-177-000
FRP Miller Solar, LLC | EG25-178-000
Take notice that during the month of April 2025, the status of the above-captioned entities as Exempt Wholesale Generators became effective by operation of the Commission's regulations. 18 CFR 366.7(a) (2024).
Dated: May 5, 2025.
Carlos D. Clay,

Deputy Secretary.
DEPARTMENT OF ENERGY
Federal Energy Regulatory Commission
Combined Notice of Filings
Take notice that the Commission has received the following Natural Gas Pipeline Rate and Refund Report filings:

Filings Instituting Proceedings
Docket Numbers: RP25-891-000.
Applicants: Gulf South Pipeline Company, LLC.
Description: § 4(d) Rate Filing: Cap Rel Neg Rate Agmt (Osaka 46428 to TotalEnergies 59405) to be effective 5/2/2025.
Filed Date: 5/2/25.
Accession Number: 20250502-5158.
Comment Date: 5 p.m. ET 5/14/25.
Any person desiring to intervene, to protest, or to answer a complaint in any of the above proceedings must file in accordance with Rules 211, 214, or 206 of the Commission's Regulations (18 CFR 385.211, 385.214, or 385.206) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.

Filings in Existing Proceedings
Docket Numbers: RP25-484-001.
Applicants: Gulf Shore Energy Partners, LP.
Description: Compliance filing: Gulf Shore Amended NAESB 4.0 Compliance Filing to be effective 8/1/2025.
Filed Date: 5/2/25.
Accession Number: 20250502-5132.
Comment Date: 5 p.m. ET 5/14/25.
Docket Numbers: RP25-536-001.
Applicants: Leaf River Energy Center LLC.
Description: Compliance filing: Leaf River Amended NAESB 4.0 Compliance Filing to be effective 8/1/2025.
Filed Date: 5/2/25.
Accession Number: 20250502-5147.
Comment Date: 5 p.m. ET 5/14/25.
Any person desiring to protest in any the above proceedings must file in accordance with Rule 211 of the Commission's Regulations (18 CFR 385.211) on or before 5:00 p.m. Eastern time on the specified comment date.
The filings are accessible in the Commission's eLibrary system ( https://elibrary.ferc.gov/idmws/search/fercgensearch.asp ) by querying the docket number.
eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call (866) 208-3676 (toll free). For TTY, call (202) 502-8659.
The Commission's Office of Public Participation (OPP) supports meaningful public engagement and participation in Commission proceedings. OPP can help members of the public, including landowners, community organization, Tribal members and others, access publicly available information and navigate Commission processes. For public inquiries and assistance with making filings such as interventions, comments, or requests for rehearing, the public is encouraged to contact OPP at (202) 502-6595 or OPP@ferc.gov.
Dated: May 5, 2025.
Carlos D. Clay,

Deputy Secretary.
DEPARTMENT OF ENERGY
Federal Energy Regulatory Commission
[Project No. 553-000]
City of Seattle, Washington; Notice of Authorization for Continued Project Operation
The license for the Skagit River Hydroelectric Project No. 553 was issued for a period ending April 30, 2025.
Section 15(a)(1) of the FPA, 16 U.S.C. 808(a)(1), requires the Commission, at the expiration of a license term, to issue from year-to-year an annual license to the then licensee(s) under the terms and conditions of the prior license until a new license is issued, or the project is otherwise disposed of as provided in section 15 or any other applicable section of the FPA. If the project's prior license waived the applicability of section 15 of the FPA, then, based on section 9(b) of the Administrative Procedure Act, 5 U.S.C. 558(c), and as set forth at 18 CFR 16.21(a), if the licensee of such project has filed an application for a subsequent license, the licensee may continue to operate the project in accordance with the terms and conditions of the license after the minor or minor part license expires, until the Commission acts on its application. If the licensee of such a project has not filed an application for a subsequent license, then it may be required, pursuant to 18 CFR 16.21(b), to continue project operations until the Commission issues someone else a license for the project or otherwise orders disposition of the project.
If the project is subject to section 15 of the FPA, notice is hereby given that an annual license for Project No. 553 is issued to City of Seattle, Washington for a period effective May 1, 2025, through April 30, 2026, or until the issuance of a new license for the project or other disposition under the FPA, whichever comes first.
If issuance of a new license (or other disposition) does not take place on or before April 30, 2026, notice is hereby given that, pursuant to 18 CFR 16.18(c), an annual license under section 15(a)(1) of the FPA is renewed automatically without further order or notice by the Commission, unless the Commission orders otherwise.
If the project is not subject to section 15 of the FPA, notice is hereby given that City of Seattle, Washington is authorized to continue operation of the Skagit River Hydroelectric Project under the terms and conditions of the prior license until the issuance of a subsequent license for the project or other disposition under the FPA, whichever comes first.
Dated: May 6, 2025.
Debbie-Anne A. Reese,

Secretary.
DEPARTMENT OF ENERGY
Federal Energy Regulatory Commission
Combined Notice of Filings #1
Take notice that the Commission received the following electric rate filings:
Docket Numbers: ER10-1852-108; ER19-774-014; ER10-2641-052.
Applicants: Oleander Power Project, Limited Partnership, Stanton Clean Energy, LLC, Florida Power & Light Company.
Description: Notice of Change in Status of Florida Power & Light Company, et al.
Filed Date: 4/28/25.
Accession Number: 20250428-5311.
Comment Date: 5 p.m. ET 5/19/25.
Docket Numbers: ER10-3181-007; ER17-424-011; ER17-991-011; ER13-823-009; ER12-1561-006; ER15-1348-004; ER24-2589-003; ER24-2590-003.
Applicants: Castleton Commodities Energy Trading LLC, Castleton Commodities Energy Services LLC, Roseton Generating LLC, LDH Rensselaer LLC, Castleton Commodities Merchant Trading L.P., Hunlock Energy, LLC, Footprint Power Salem Harbor Development LP, UGI Development Company.
Description: Notice of Non-Material Change in Status of Hunlock Creek Generating LLC, et al.
Filed Date: 4/29/25.
Accession Number: 20250429-5383.
Comment Date: 5 p.m. ET 5/20/25.
Docket Numbers: ER13-738-013; ER11-3097-017; ER10-1186-016; ER12-421-007; ER11-2731-007.
Applicants: Heritage Stoney Corners Wind Farm I, LLC, Heritage Garden Wind Farm I, LLC, DTE Energy Supply, LLC, DTE Energy Trading, Inc., DTE Electric Company.
Description: Notice of Change in Status of DTE Electric Company, et al.
Filed Date: 4/29/25.
Accession Number: 20250429-5384.
Comment Date: 5 p.m. ET 5/20/25.
Docket Numbers: ER17-1394-012; ER10-1330-015; ER10-1427-015; ER10-2917-031; ER10-2922-031; ER11-2383-028; ER11-3376-013; ER11-3377-014; ER11-3378-014; ER12-161-034; ER12-2313-013; ER13-1139-028; ER14-1964-023; ER14-2630-021; ER16-141-012; ER16-287-017; ER17-360-007; ER17-361-007; ER17-362-007; ER17-482-017; ER17-539-006; ER17-540-006; ER19-89-004; ER19-529-022; ER19-1074-022; ER19-1075-022; ER19-2429-011; ER20-1447-013; ER20-2028-008; ER22-192-014; ER22-398-005; ER22-1010-012; ER22-1019-005; ER22-1627-006; ER23-2363-007; ER23-2481-006; ER24-443-007; ER24-444-006; ER24-1271-004; ER24-1272-004; ER24-1449-004; ER24-2271-003; ER24-2272-002; ER24-2273-003; ER24-2467-003; ER25-567-002.
Applicants: BR Pacific Hydro Power LLC, Spanish Peaks Solar LLC, Jones Farm Lane Solar, LLC, Egypt Road Solar, LLC, Aspen Road Solar 1, LLC, Goose Prairie Solar LLC, Foxglove Solar Project, LLC, Alton Post Office Solar, LLC, Deriva Energy Beckjord Storage LLC, Deriva Energy Services, LLC, Crystal Hill Solar, LLC, HXOap Solar One, LLC, AM Wind Repower LLC, Powell River Energy Inc., TerraForm IWG Acquisition Holdings II, LLC, Mesa Wind Power LLC, Evolugen Trading and Marketing LP, Bitter Ridge Wind Farm, LLC, Brookfield Energy Marketing US LLC, Brookfield Smoky Mountain Hydropower LP, Brookfield Renewable Energy Marketing US LLC, Brookfield Energy Marketing Inc., Brookfield Renewable Trading and Marketing LP, North Rosamond Solar, LLC, Wildwood Solar II, LLC, Wildwood Solar I, LLC, BREG Aggregator LLC, Rio Bravo Solar II, LLC, Pumpjack Solar I, LLC, Rio Bravo Solar I, LLC, BIF III Holtwood LLC, Conetoe II Solar, LLC, Regulus Solar, LLC, BIF II Safe Harbor Holdings, LLC, Imperial Valley Solar 1, LLC, Laurel Hill Wind Energy, LLC, Bishop Hill Energy LLC, South Hurlburt Wind, LLC, Horseshoe Bend Wind, LLC, North Hurlburt Wind, LLC, Safe Harbor Water Power Corporation, Hawks Nest Hydro LLC, Brookfield Power Piney & Deep Creek LLC, Brookfield Energy Marketing LP, North Allegheny Wind, LLC, 83WI 8me, LLC.
Description: Notice of Non-Material Change in Status of 83WI 8me, LLC, et al.
Filed Date: 4/29/25.
Accession Number: 20250429-5382.
Comment Date: 5 p.m. ET 5/20/25.
Docket Numbers: ER17-1394-011; ER10-1328-007; ER10-1-004; ER10-1330-014; ER10-1331-007; ER10-1332-007; ER10-2460-024; ER10-2461-025; ER10-2463-022; ER10-2466-025; ER10-2522-008; ER10-2567-008; ER10-2895-027; ER10-2917-030; ER10-2918-027; ER10-2920-027; ER10-2921-027; ER10-2922-030; ER10-2966-027; ER10-3167-020; ER11-2201-030; ER11-2383-027; ER11-3376-012; ER11-3377-013; ER11-3378-013; ER11-4029-024; ER12-161-033; ER12-645-030; ER12-682-025; ER12-1311-024; ER12-1502-011; ER12-1504-011; ER12-2068-024; ER12-2313-012; ER13-17-023; ER13-203-019; ER13-1139-027; ER13-1613-020; ER13-2143-020; ER14-25-025; ER14-1964-022; ER14-2630-020; ER16-61-007; ER16-63-007; ER16-64-007; ER16-141-011; ER16-287-016; ER16-355-009; ER16-2527-008; ER17-2-009; ER17-360-006; ER17-361-006; ER17-362-006; ER17-482-016; ER17-539-005; ER17-540-005; ER17-2336-010; ER18-1343-019; ER19-89-003; ER19-529-021; ER19-1074-021; ER19-1075-021; ER19-1819-009; ER19-1820-009; ER19-1821-009; ER19-2429-010; ER19-2684-005; ER19-2728-006; ER19-2729-006; ER20-1447-012; ER20-1487-007; ER20-1806-008; ER20-2028-007; ER21-2426-005; ER22-192-013; ER22-398-004; ER22-1010-011; ER22-1019-004; ER22-1627-005; ER22-1883-006; ER22-2042-005; ER23-921-004; ER23-1889-003; ER23-1939-004; ER23-2203-005; ER23-2363-006; ER23-2481-005; ER24-443-006; ER24-444-005; ER24-957-003; ER24-1271-003; ER24-1272-003; ER24-1449-003; ER24-2271-002; ER24-2272-001; ER24-2273-002; ER24-2467-002; ER24-2580-001; ER25-567-001.
Applicants: BR Pacific Hydro Power LLC, White Pine Hydro, LLC, Spanish Peaks Solar LLC, Jones Farm Lane Solar, LLC, Egypt Road Solar, LLC, Aspen Road Solar 1, LLC, Goose Prairie Solar LLC, Foxglove Solar Project, LLC, Alton Post Office Solar, LLC, Franklin Solar LLC, Deriva Energy Beckjord Storage LLC, Deriva Energy Services, LLC, Crystal Hill Solar, LLC, HXOap Solar One, LLC, Wildflower Solar, LLC, Pike Solar LLC, Sweetland Wind Farm, LLC, Black Mesa Energy, LLC, Jackpot Holdings, LLC, Ledyard Windpower, LLC,AM Wind Repower LLC, Powell River Energy Inc., TerraForm IWG Acquisition Holdings II, LLC, Mesa Wind Power LLC, Evolugen Trading and Marketing LP, CPRE 1 Lessee, LLC, Bitter Ridge Wind Farm, LLC, Catalyst Old River Hydroelectric Limited Partnership, Frontier Windpower II, LLC, Brookfield Energy Marketing US LLC, Lily Solar Lessee, LLC, Lily Solar LLC, Palmer Solar, LLC, Brookfield Smoky Mountain Hydropower LP, Speedway Solar NC, LLC, Stony Knoll Solar, LLC, Broad River Solar, LLC, Brookfield Renewable Energy Marketing US LLC, Brookfield Energy Marketing Inc., Brookfield Renewable Trading and Marketing LP, North Rosamond Solar, LLC, Carolina Solar Power, LLC, Shoreham Solar Commons LLC, Wildwood Solar II, LLC, Wildwood Solar I, LLC, BREG Aggregator LLC, Rio Bravo Solar II, LLC, Pumpjack Solar I, LLC, Rio Bravo Solar I, LLC, Frontier Windpower, LLC, Caprock Solar I LLC, Colonial Eagle Solar, LLC, BIF III Holtwood LLC, Conetoe II Solar, LLC, Tallbear Seville LLC, Seville Solar Two, LLC, Seville Solar One LLC, Regulus Solar, LLC, LSP Safe Harbor Holdings, LLC, Prairie Breeze Wind Energy LLC, Black Bear Development Holdings, LLC, Brookfield White Pine Hydro LLC, Imperial Valley Solar 1, LLC, Black Bear SO, LLC, Niagara Wind Power, LLC, Laurel Hill Wind Energy, LLC, Blue Sky East, LLC, Cimarron Windpower II, LLC, Ironwood Windpower, LLC, Stetson Holdings, LLC, Erie Wind, LLC, California Ridge Wind Energy LLC, Bishop Hill Energy LLC, Vermont Wind, LLC, South Hurlburt Wind, LLC, Horseshoe Bend Wind, LLC, North Hurlburt Wind, LLC, Safe Harbor Water Power Corporation, Evergreen Wind Power III, LLC, Black Bear Hydro Partners, LLC, Rumford Falls Hydro LLC, Hawks Nest Hydro LLC, Great Lakes Hydro America, LLC, Erie Boulevard Hydropower, L.P., Carr Street Generating Station, L.P., Brookfield Power Piney & Deep Creek LLC, Bear Swamp Power Company LLC, Kit Carson Windpower, LLC, Top of the World Wind Energy, LLC, Stetson Wind II, LLC, Evergreen Wind Power, LLC, Canandaigua Power Partners II, LLC, Canandaigua Power Partners, LLC, Three Buttes Windpower, LLC, Silver Sage Windpower, LLC, North Allegheny Wind, LLC, High Majestic Wind Energy Center, LLC, Happy Jack Windpower, LLC, 83WI 8me, LLC.
Description: Notice of Non-Material Change in Status of 83WI 8me, LLC, et al.
Filed Date: 4/29/25.
Accession Number: 20250429-5379.
Comment Date: 5 p.m. ET 5/20/25.
Docket Numbers: ER19-2343-005; ER10-2798-022; ER10-2799-022; ER10-2878-023; ER10-2879-022; ER21-2423-011; ER21-2424-011; ER22-1449-006; ER22-1450-006; ER24-762-004.
Applicants: Elevate Renewables F7, LLC, GB II New Haven LLC, GB II Connecticut LLC, Generation Bridge M&M Holdings, LLC, Generation Bridge Connecticut Holdings, LLC, Montville Power LLC, Middleton Power LLC, Devon Power LLC, Connecticut Jet Power LLC, 2018 ESA Project Company, LLC.
Description: Notice of Non-Material Change in Status of 2018 ESA Project Company, LLC, et al.
Filed Date: 4/29/25.
Accession Number: 20250429-5381.
Comment Date: 5 p.m. ET 5/20/25.
Docket Numbers: ER23-2511-005; ER11-2036-018; ER19-1597-010; ER19-2527-005; ER20-902-009; ER20-1593-009; ER20-1594-008; ER20-1596-009; ER20-1597-009; ER20-1599-009; ER20-1620-010; ER20-1629-010; ER21-2767-006; ER22-414-010; ER22-1518-006; ER23-495-011; ER23-1503-004; ER23-2346-006; \ER23-2439-005; ER23-2448-006; ER23-2450-005; ER23-2451-005; ER23-2456-002; ER24-1732-002; ER24-2103-004; ER24-2327-004; ER25-59-001; ER25-160-001.
Applicants: Morris Solar, LLC, AES Pike County Energy Storage, LLC, Calhoun County Solar Project, LLC, Keydet Solar Center, LLC, Sol Madison Solar, LLC, Platteview Solar, LLC, Great Cove Solar II LLC, Great Cove Solar LLC, Tunica Windpower LLC, Cavalier Solar A2, LLC, Oak Ridge Solar, LLC, Cavalier Solar A, LLC, AES CE Solutions, LLC, Laurel Mountain BESS, LLC, AES Marketing and Trading, LLC, Skipjack Solar Center, LLC, AES ES Alamitos, LLC, AES Solutions Management, LLC, Richmond Spider Solar, LLC, Pleinmont Solar 2, LLC, Pleinmont Solar 1, LLC, Highlander IA, LLC, Highlander Solar Energy Station 1, LLC, sPower Energy Marketing, LLC, Prevailing Wind Park, LLC, AES Integrated Energy, LLC, AES Laurel Mountain, LLC, Hardy Hills Solar Energy LLC.
Description: Notice of Change in Status of Hardy Hills Solar Energy LLC, et al.
Filed Date: 4/28/25.
Accession Number: 20250428-5310.
Comment Date: 5 p.m. ET 5/19/25.
Docket Numbers: ER24-3011-001; ER17-2580-004; ER24-2238-001; ER24-2239-001; ER24-2240-001; ER24-2242-001; ER24-2243-001; ER24-3097-001; ER24-3098-001; ER24-3099-001; ER24-3100-001.
Applicants: Reworld Plymouth, LLC, Reworld Fairfax, LLC, Reworld Essex Company, Reworld Delaware Valley, L.P., Reworld Union (NJ), LLC, Reworld REC, LLC, Reworld Niagara I, LLC, Reworld Hempstead Company, Reworld Haverhill Associates, LLC, SEMASS Partnership, Reworld Camden County, L.P.
Description: Notice of Non-Material Change in Status of Reworld Camden County, L.P., et al.
Filed Date: 4/29/25.
Accession Number: 20250429-5380.
Comment Date: 5 p.m. ET 5/20/25.
Docket Numbers: ER25-451-001; ER10-3116-015; ER10-3120-017; ER10-3128-017; ER10-3145-018; ER11-2701-019; ER15-760-020; ER15-762-023; ER15-1579-021; ER15-1582-022; ER15-1914-023; ER15-2680-019; ER16-468-017; ER16-474-018; ER16-890-018; ER16-1255-020; ER16-1738-017; ER16-1901-017; ER16-1955-017; ER16-1956-017; ER16-1973-017; ER16-2201-016; ER16-2224-016; ER16-2578-017; ER17-306-016; ER17-544-016; ER17-1864-015; ER17-1871-015; ER17-1909-015; ER18-1667-012; ER18-2492-013; ER19-846-012; ER19-847-012; ER19-1473-007; ER19-1474-006; ER19-1597-009; ER20-902-008; ER20-1620-009; ER20-1629-009; ER20-2065-007; ER20-2066-007; ER20-2519-006; ER21-1488-007; ER21-2156-007; ER21-2766-006; ER22-414-009; ER22-799-007; ER23-48-005; ER23-495-010; ER23-937-004; ER23-1165-003; ER23-1319-004; ER23-1589-004; ER23-1668-005; ER23-1669-005; ER23-2440-003; ER23-2441-004; ER24-55-004; ER24-1035-004; ER24-1697-002; ER24-1698-003; ER24-2148-002.
Applicants: McFarland Storage C, LLC, AES ES Alamitos 2, LLC, AES Westwing II ES, LLC, 20SD 8me LLC, Silver Peak Energy, LLC, Chevelon Butte RE II LLC, McFarland Solar B, LLC, Raceway Solar 1, LLC, Estrella Solar, LLC, AES ES Westwing, LLC, Baldy Mesa Solar, LLC, McFarland Solar A, LLC, Chevelon Butte RE LLC, AES CE Solutions, LLC, West Line Solar, LLC, Lancaster Area Battery Storage, LLC, AES Marketing and Trading, LLC, Central Line Solar, LLC, Antelope Expansion 1B, LLC, Luna Storage, LLC, East Line Solar, LLC, Antelope Expansion 3B, LLC, Antelope Expansion 3A, LLC, AES ES Tait, LLC, AES Solutions Management, LLC, sPower Energy Marketing, LLC, AES Integrated Energy, LLC, AES Huntington Beach Energy, LLC, AES Alamitos Energy, LLC, San Pablo Raceway, LLC, Antelope DSR 3, LLC, FTS Master Tenant 2, LLC, Antelope Expansion 2, LLC, Bayshore Solar C, LLC, Bayshore Solar B, LLC, Bayshore Solar A, LLC, Beacon Solar 1, LLC, Beacon Solar 3, LLC, North Lancaster Ranch LLC, Solverde 1, LLC, Antelope DSR 1, LLC, Western Antelope Blue Sky Ranch B LLC, Western Antelope Dry Ranch LLC, Antelope DSR 2, LLC, Elevation Solar C LLC, Beacon Solar 4, LLC, Antelope Big Sky Ranch LLC, Summer Solar LLC, Central Antelope Dry Ranch C LLC, FTS Master Tenant 1, LLC, Sandstone Solar LLC, 87RL 8me LLC, 65HK 8me LLC, 67RK 8me LLC, Sierra Solar Greenworks LLC, Western Antelope Blue Sky Ranch A LLC, Mountain View Power Partners IV, LLC, AES Alamitos, LLC, AES Redondo Beach, L.L.C., AES Huntington Beach, L.L.C., AES Energy Storage, LLC, 50LW 8me LLC.
Description: Notice of Non-Material Change in Status of 50LW 8me LLC, et al.
Filed Date: 4/28/25.
Accession Number: 20250428-5309.
Comment Date: 5 p.m. ET 5/19/25.
Docket Numbers: ER25-2081-000; ER10-1781-010; ER19-2626-012; ER21-714-013; ER22-381-016; ER22-399-008; ER23-2321-006.
Applicants: Dunns Bridge Energy Storage, LLC, Meadow Lake Solar Park LLC, Dunns Bridge Solar Center, LLC, Indiana Crossroads Wind Farm LLC, Rosewater Wind Farm LLC, Northern Indiana Public Service Company, Fairbanks Solar Energy Center LLC.
Description: Notice of Non-Material Change in Status and Market-Based Rate Tariff Revisions of Fairbanks Solar Energy Center LLC, et al.
Filed Date: 4/29/25.
Accession Number: 20250429-5385.
Comment Date: 5 p.m. ET 5/20/25.
The filings are accessible in the Commission's eLibrary system ( https://elibrary.ferc.gov/idmws/search/fercgensearch.asp ) by querying the docket number.
Any person desiring to intervene, to protest, or to answer a complaint in any of the above proceedings must file in accordance with Rules 211, 214, or 206 of the Commission's Regulations (18 CFR 385.211, 385.214, or 385.206) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.
eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call (866) 208-3676 (toll free). For TTY, call (202) 502-8659.
The Commission's Office of Public Participation (OPP) supports meaningful public engagement and participation in Commission proceedings. OPP can help members of the public, including landowners, community organization, Tribal members and others, access publicly available information and navigate Commission processes. For public inquiries and assistance with making filings such as interventions, comments, or requests for rehearing, the public is encouraged to contact OPP at (202) 502-6595 or OPP@ferc.gov.
Dated: May 5, 2025.
Carlos D. Clay,

Deputy Secretary
DEPARTMENT OF ENERGY
Federal Energy Regulatory Commission
Combined Notice of Filings #2
Take notice that the Commission received the following exempt wholesale generator filings:
Docket Numbers: EG25-312-000.
Applicants: Coldwater River Solar, LLC.
Description: Coldwater River Solar, LLC submits Notice of Self-Certification of Exempt Wholesale Generator Status.
Filed Date: 5/6/25.
Accession Number: 20250506-5128.
Comment Date: 5 p.m. ET 5/27/25.
Docket Numbers: EG25-313-000.
Applicants: Badger Wind, LLC.
Description: Badger Wind, LLC submits Notice of Self-Certification of Exempt Wholesale Generator Status.
Filed Date: 5/6/25.
Accession Number: 20250506-5135.
Comment Date: 5 p.m. ET 5/27/25.
Take notice that the Commission received the following electric rate filings:
Docket Numbers: ER25-2071-001.
Applicants: PJM Interconnection, L.L.C.
Description: Tariff Amendment: Amendment of NSA, Original SA No. 7663; Queue No. AB2-133 in Docket No. ER25-2071 to be effective 6/29/2025.
Filed Date: 5/6/25.
Accession Number: 20250506-5074.
Comment Date: 5 p.m. ET 5/27/25.
Docket Numbers: ER25-2161-000.
Applicants: Mid-Atlantic Interstate Transmission, LLC.
Description: § 205(d) Rate Filing: MAIT submits 3 amended ECSAs—SA #s 6941, 6944, and 7221 to be effective 7/7/2025.
Filed Date: 5/6/25.
Accession Number: 20250506-5090.
Comment Date: 5 p.m. ET 5/27/25.
The filings are accessible in the Commission's eLibrary system ( https://elibrary.ferc.gov/idmws/search/fercgensearch.asp ) by querying the docket number.
Any person desiring to intervene, to protest, or to answer a complaint in any of the above proceedings must file in accordance with Rules 211, 214, or 206 of the Commission's Regulations (18 CFR 385.211, 385.214, or 385.206) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.
eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at: https://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call (866) 208-3676 (toll free). For TTY, call (202) 502-8659.
The Commission's Office of Public Participation (OPP) supports meaningful public engagement and participation in Commission proceedings. OPP can help members of the public, including landowners, community organization, Tribal members and others, access publicly available information and navigate Commission processes.
For public inquiries and assistance with making filings such as interventions, comments, or requests for rehearing, the public is encouraged to contact OPP at (202) 502-6595 or OPP@ferc.gov.
Dated: May 6, 2025.
Carlos D. Clay,

Deputy Secretary.
DEPARTMENT OF ENERGY
Federal Energy Regulatory Commission
Combined Notice of Filings #1
Take notice that the Commission received the following exempt wholesale generator filings:
Docket Numbers: EG25-311-000.
Applicants: Bexar ESS LLC.
Description: Bexar ESS LLC submits Notice of Self-Certification of Exempt Wholesale Generator Status.
Filed Date: 5/5/25.
Accession Number: 20250505-5256.
Comment Date: 5 p.m. ET 5/27/25.
Take notice that the Commission received the following electric rate filings:
Docket Numbers: ER10-2727-011; ER10-1451-013; ER10-1467-014 ER10-1469-013; ER10-2687-013; ER10-2688-016 ER10-2728-015; ER11-3907-007; ER24-172-005.
Applicants: FirstEnergy Pennsylvania Electric Company, The Toledo Edison Company, Green Valley Hydro, LLC, The Potomac Edison Company, Monongahela Power Company, The Cleveland Electric Illuminating Company, Ohio Edison Company, Jersey Central Power & Light, Allegheny Energy Supply Company, LLC.
Description: Notice of Non-Material Change in Status of Allegheny Energy Supply Company, LLC, et al. under ER10-2727.
Filed Date: 4/30/25.
Accession Number: 20250430-5696.
Comment Date: 5 p.m. ET 5/21/25.
Docket Numbers: ER13-2386-011; ER10-2806-013; ER10-2818-013 ER10-2847-010; ER18-1984-007; ER21-2712-004.
Applicants: Heartland Generation Ltd., Big Level Wind LLC, TransAlta Centralia Generation LLC, TransAlta Energy Marketing Corporation, TransAlta Energy Marketing (U.S.) Inc., Lakeswind Power Partners, LLC.
Description: Notice of Change in Status of Lakeswind Power Partners, LLC, et al.
Filed Date: 4/30/25.
Accession Number: 20250430-5705.
Comment Date: 5 p.m. ET 5/21/25.
Docket Numbers: ER16-700-009.
Applicants: CPV Towantic, LLC.
Description: Notice of Change in Status of CPV Towantic, LLC.
Filed Date: 4/30/25.
Accession Number: 20250430-5701.
Comment Date: 5 p.m. ET 5/21/25.
Docket Numbers: ER16-1999-003; ER11-4625-009; ER14-608-007 ER16-1644-007; ER16-1998-003; ER16-2000-003 ER16-2001-003; ER16-2002-003; ER16-2003-003 ER16-2006-003; ER19-537-006; ER24-1653-001 ER24-2557-002; ER24-2558-001; ER24-2559-002.
Applicants: Malaga BESS LLC, Hanford BESS LLC, Henrietta BESS LLC, MRP Pacifica Marketing LLC, MRP San Joaquin Energy, LLC, CalPeak Power—Vaca Dixon LLC, CalPeak Power—Panoche LLC, Midway Peaking, LLC, Malaga Power, LLC, CalPeak Power—Enterprise LLC, CalPeak Power—Border LLC, MRP Generation Holdings, LLC, High Desert Power Project, LLC, Colton Power L.P., CalPeak Power LLC.
Description: Notice of Non-Material Change in Status of CalPeak Power LLC, et al.
Filed Date: 4/30/25.
Accession Number: 20250430-5695.
Comment Date: 5 p.m. ET 5/21/25.
Docket Numbers: ER17-556-008; ER23-2469-003; ER10-1362-009 ER11-3959-011; ER12-726-011; ER12-2639-013 ER15-1019-011; ER17-104-010; ER17-105-010 ER18-2158-005; ER21-2330-003; ER21-2331-003 ER21-2333-003; ER21-2336-003; ER22-2703-006.
Applicants: Pattern Energy Management Services LLC, Tecolote Wind LLC, Red Cloud Wind LLC, Duran Mesa LLC, Clines Corners Wind Farm LLC, Stillwater Wind, LLC, Broadview Energy JN, LLC, Broadview Energy KW, LLC, Fowler Ridge IV Wind Farm LLC, Ocotillo Express LLC, Spring Valley Wind LLC, Post Rock Wind Power Project, LLC, Hatchet Ridge Wind, LLC, Lost Creek Wind, LLC, Grady Wind Energy Center, LLC.
Description: Notice of Change in Status of Grady Wind Energy Center, LLC, et al.
Filed Date: 4/30/25.
Accession Number: 20250430-5700.
Comment Date: 5 p.m. ET 5/21/25.
Docket Numbers: ER20-391-013; ER21-2557-008; ER22-2662-008 ER22-2663-008; ER22-2664-008; ER23-1275-006 ER23-1276-006; ER23-1277-006; ER24-1276-004 ER24-2249-004; ER24-2250-004; ER24-2251-003 ER24-2854-002; ER24-2855-002; ER24-2856-002 ER25-938-001; ER25-939-001; ER25-940-001 ER25-1422-001.
Applicants: Aron Energy Prepay 57 LLC, Aron Energy Prepay 53 LLC, Aron Energy Prepay 52 LLC, Aron Energy Prepay 51 LLC, Aron Energy Prepay 46 LLC, Aron Energy Prepay 45 LLC, Aron Energy Prepay 44 LLC, Aron Energy Prepay 43 LLC, Aron Energy Prepay 42 LLC, Aron Energy Prepay 41 LLC, Aron Energy Prepay 35 LLC, Aron Energy Prepay 23 LLC, Aron Energy Prepay 22 LLC, Aron Energy Prepay 21 LLC, Aron Energy Prepay 16 LLC, Aron Energy Prepay 15 LLC, Aron Energy Prepay 14 LLC, Aron Energy Prepay 5 LLC, J. Aron & Company LLC.
Description: Notice of Non-Material Change in Status of J. Aron & Company LLC, et al.
Filed Date: 4/30/25.
Accession Number: 20250430-5697.
Comment Date: 5 p.m. ET 5/21/25.
Docket Numbers: ER21-2445-005; ER23-2716-003; ER25-561-001 ER25-562-001.
Applicants: Winfield Solar I, LLC, Crossover Wind LLC, Moraine Sands Wind Power, LLC, Glacier Sands Wind Power, LLC.
Description: Notice of Non-Material Change in Status of Glacier Sands Wind Power, LLC, et al.
Filed Date: 4/30/25.
Accession Number: 20250430-5704.
Comment Date: 5 p.m. ET 5/21/25.
Docket Numbers: ER21-2557-009; ER22-2662-009; ER22-2663-009 ER22-2664-009; ER23-1275-007; ER23-1276-007 ER24-2249-005; ER24-2251-004; ER24-2854-003 ER24-2855-003; ER24-2856-003.
Applicants: Aron Energy Prepay 46 LLC, Aron Energy Prepay 45 LLC, Aron Energy Prepay 44 LLC, Aron Energy Prepay 43 LLC, Aron Energy Prepay 41 LLC, Aron Energy Prepay 22 LLC, Aron Energy Prepay 21 LLC, Aron Energy Prepay 16 LLC, Aron Energy Prepay 15 LLC, Aron Energy Prepay 14 LLC, Aron Energy Prepay 5 LLC.
Description: Notice of Non-Material Change in Status of Aron Energy Prepay 5 LLC, et al.
Filed Date: 4/30/25.
Accession Number: 20250430-5699.
Comment Date: 5 p.m. ET 5/21/25.
Docket Numbers: ER22-2784-008; ER14-41-014; ER14-42-014; ER16-498-013; ER16-499-013; ER16-500-013 ER16-2277-007; ER16-2289-008; ER18-1174-008; ER20-2448-009; ER21-133-009; ER21-736-010; ER21-1962-010; ER21-2634-008; ER25-590-002.
Applicants: Pome BESS LLC, Solar Star Lost Hills, LLC, Mulberry BESS LLC, RE Slate 1 LLC, HDSI, LLC, American Kings Solar, LLC, Imperial Valley Solar 2, LLC, Golden Fields Solar I, LLC, Solar Star California XLI, LLC, RE Mustang 4 LLC, RE Mustang 3 LLC, RE Mustang LLC, RE Rosamond Two LLC, RE Rosamond One LLC, MN8 Energy Marketing LLC.
Description: Notice of Non-Material Change in Status of MN8 Energy Marketing LLC, et al.
Filed Date: 4/30/25.
Accession Number: 20250430-5702.
Comment Date: 5 p.m. ET 5/21/25.
Docket Numbers: ER22-2784-009; ER21-632-004; ER22-2827-005 ER23-108-003; ER23-2967-003.
Applicants: Pome BESS LLC, Solar Star Lost Hills, LLC, Mulberry BESS LLC, RE Slate 1 LLC, HDSI, LLC, American Kings Solar, LLC, Imperial Valley Solar 2, LLC, Golden Fields Solar I, LLC, Solar Star California XLI, LLC, RE Mustang 4 LLC, RE Mustang 3 LLC, RE Mustang LLC, RE Rosamond Two LLC, RE Rosamond One LLC, MN8 Energy Marketing LLC.
Description: Notice of Non-Material Change in Status of MN8 Energy Marketing LLC, et al.
Filed Date: 4/30/25.
Accession Number: 20250430-5703.
Comment Date: 5 p.m. ET 5/21/25.
Docket Numbers: ER23-2091-004.
Applicants: Goleta Energy Storage, LLC.
Description: Notice of Non-Material Change in Status of Goleta Energy Storage, LLC.
Filed Date: 4/30/25.
Accession Number: 20250430-5698.
Comment Date: 5 p.m. ET 5/21/25.
Docket Numbers: ER25-2158-000.
Applicants: PJM Interconnection, L.L.C.
Description: § 205(d) Rate Filing: Original GIA, Service Agreement No. 7664; AG1-483 to be effective 4/4/2025.
Filed Date: 5/5/25.
Accession Number: 20250505-5197.
Comment Date: 5 p.m. ET 5/27/25.
Docket Numbers: ER25-2159-000.
Applicants: Duke Energy Progress, LLC.
Description: Tariff Amendment: DEP—NCEMC Notice of Termination of the Reimbursement Agreement RS No. 449 to be effective 7/5/2025.
Filed Date: 5/5/25.
Accession Number: 20250505-5200.
Comment Date: 5 p.m. ET 5/27/25.
Docket Numbers: ER25-2160-000.
Applicants: PJM Interconnection, L.L.C.
Description: § 205(d) Rate Filing: Amendment to ISA, SA No. 7087; Queue No. AF1-062 (amend) to be effective 7/6/2025.
Filed Date: 5/6/25.
Accession Number: 20250506-5042.
Comment Date: 5 p.m. ET 5/27/25.
The filings are accessible in the Commission's eLibrary system ( https://elibrary.ferc.gov/idmws/search/fercgensearch.asp ) by querying the docket number. Any person desiring to intervene, to protest, or to answer a complaint in any of the above proceedings must file in accordance with Rules 211, 214, or 206 of the Commission's Regulations (18 CFR 385.211, 385.214, or 385.206) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.
eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at: https://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call (866) 208-3676 (toll free). For TTY, call (202) 502-8659.
The Commission's Office of Public Participation (OPP) supports meaningful public engagement and participation in Commission proceedings. OPP can help members of the public, including landowners, community organization, Tribal members and others, access publicly available information and navigate Commission processes. For public inquiries and assistance with making filings such as interventions, comments, or requests for rehearing, the public is encouraged to contact OPP at (202) 502-6595 or OPP@ferc.gov.
Dated: May 6, 2025.
Carlos D. Clay,

Deputy Secretary.
DEPARTMENT OF ENERGY
Federal Energy Regulatory Commission
[Project No. 10441-020]
City of Aspen, Colorado; Notice of Application Tendered for Filing With the Commission and Soliciting Additional Study Requests
Take notice that the following hydroelectric application has been filed with the Commission and is available for public inspection.
a. Type of Application: Exemption from Licensing. ^1
^1 The applicant is an existing licensee for the project in which the license expires on June 30, 2028. The licensee is requesting a small hydropower exemption as an authorization to continue operating and maintaining the project after the license expires. The licensee states that should the project not qualify for a small hydropower exemption, the application should be considered a subsequent license application.
b. Project No.: 10441-020.
c. Date Filed: April 8, 2025.
d. Applicant: City of Aspen, Colorado.
e. Name of Project: Maroon Creek Hydroelectric Project.
f. Location: On Maroon Creek in Pitkin County, Colorado.
g. Filed Pursuant to: 18 CFR 16.22 and the Public Utility Regulatory Policies Act of 1978, 16 U.S.C. 2705, 2708, amended by the Hydropower Regulatory Efficiency Act of 2013, Public Law 113-23, 127 Stat. 493 (2013).
h. Applicant Contact: Phil Overenyder at City of Aspen at (970) 920-5111; or email at phil.overeynder@aspen.gov .
i. FERC Contact: Lee Baker at (202) 502-8554, or everard.baker@ferc.gov .
j. Cooperating Agencies: Federal, state, local, and Tribal agencies with jurisdiction and/or special expertise with respect to environmental issues that wish to cooperate in the preparation of the environmental document should follow the instructions for filing such requests described in item l below. Cooperating agencies should note the Commission's policy that agencies that cooperate in the preparation of the environmental document cannot also intervene. See 94 FERC ¶ 61,076 (2001).
k. Pursuant to section 4.32(b)(7) of 18 CFR of the Commission's regulations, if any resource agency, Indian Tribe, or person believes that an additional scientific study should be conducted in order to form an adequate factual basis for a complete analysis of the application on its merit, the resource agency, Indian Tribe, or person must file a request for a study with the Commission not later than 60 days from the date of filing of the application, and serve a copy of the request on the applicant.
l. Deadline for filing additional study requests and requests for cooperating agency status: July 7, 2025.
The Commission strongly encourages electronic filing. Please file additional study requests and requests for cooperating agency status using the Commission's eFiling system at https://ferconline.ferc.gov/FERCOnline.aspx . For assistance, please contact FERC Online Support at FERCOnlineSupport@ferc.gov, (866) 208-3676 (toll free), or (202) 502-8659 (TTY). In lieu of electronic filing, you may submit a paper copy. Submissions sent via the U.S. Postal Service must be addressed to: Debbie-Anne A. Reese, Secretary, Federal Energy Regulatory Commission, 888 First Street NE, Room 1A, Washington, DC 20426. Submissions sent via any other carrier must be addressed to: Debbie-Anne A. Reese, Secretary, Federal Energy Regulatory Commission, 12225 Wilkins Avenue, Rockville, Maryland 20852. All filings must clearly identify the project name and docket number on the first page: Maroon Creek Hydroelectric Project (P-10441-020).
m. The application is not ready for environmental analysis at this time.
n. The existing project works consist of: (a) a 10-foot-high, 40-foot-long reinforced concrete dam with a crest elevation of 8,245.75 feet (the Maroon Creek diversion dam); (b) a small impoundment; (c) an intake structure at the dam; (d) a 39-inch-diameter, 5,563-foot-long buried reinforced concrete penstock; (e) a 27-inch-diameter, 1,317-foot-long buried reinforced concrete penstock together with a 110-foot section of steel penstock leading to the powerhouse; (f) a powerhouse with a 450-kW turbine-generator unit; (g) a 200-foot-long trapezoidal open channel tailrace, returning the water to Maroon Creek; (h) a 0.48-kV generator leading to a three-phase, 0.48/24.9-kV step-up transformer; (i) an approximately 400-foot-long, 24.9-kV overhead power line tap connection to the Aspen Highlands circuit operated by Holy Cross Energy; and (j) appurtenant facilities.
The application describes the addition of up to 50 kW of generating capacity through two new small turbines, with two new attached generators placed at the existing diversion dam. These new units would generate power from the bypass flows released from the diversion dam without changing the time or the amount of those releases. Flows utilized by new generation equipment would be returned to the same location on the stream immediately below the dam and headgate.
o. A copy of the application can be viewed on the Commission's website at http://www.ferc.gov, using the “eLibrary” link. Enter the docket number, excluding the last three digits in the docket number field, to access the document (P-10441). For assistance, contact FERC at FERCOnlineSupport@ferc.gov, or call toll-free, (866) 208-3676 or (202) 502-8659 (TTY).
p. You may also register online at http://www.ferc.gov/docs-filing/esubscription.asp to be notified via email of new filings and issuances related to this or other pending projects. For assistance, contact FERC Online Support.
The Commission's Office of Public Participation (OPP) supports meaningful public engagement and participation in Commission proceedings. OPP can help members of the public, including landowners, community organizations, Tribal members and others, access publicly available information and navigate Commission processes. For public inquiries and assistance with making filings such as interventions, comments, or requests for rehearing, the public is encouraged to contact OPP at (202) 502-6595 or OPP@ferc.gov .
q. Procedural schedule and final amendments: The application will be processed according to the following preliminary schedule. Revisions to the schedule will be made as appropriate.
Milestone | Target date
Issue Deficiency Letter and Additional Information Request (if necessary) | June 2025.
Issue Acceptance Letter | September 2025.
Issue Scoping Document 1 for comments | October 2025.
Issue Scoping Document 2 (if necessary) | January 2026.
Issue Notice of Ready for Environmental Analysis | January 2026.
Final amendments to the application must be filed with the Commission no later than 30 days from the issuance date of the notice of ready for environmental analysis.
Dated: May 6, 2025.
Debbie-Anne A. Reese,

Secretary.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifier: CMS-209, CMS-R-52, CMS-10538, CMS-10171, and CMS-10780]
Agency Information Collection Activities: Submission for OMB Review; Comment Request

AGENCY:
Centers for Medicare & Medicaid Services, Health and Human Services (HHS).

ACTION:
Notice.

SUMMARY:
The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, and to allow a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.

DATES:
Comments on the collection(s) of information must be received by the OMB desk officer by June 11, 2025.

ADDRESSES:
Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to www.reginfo.gov/public/do/PRAMain . Find this particular information collection by selecting “Currently under 30-day Review—Open for Public Comments” or by using the search function.
To obtain copies of a supporting statement and any related forms for the proposed collection(s) summarized in this notice, please access the CMS PRA website by copying and pasting the following web address into your web browser: https://www.cms.gov/Regulations-and-Guidance/Legislation/PaperworkReductionActof1995/PRA-Listing .

FOR FURTHER INFORMATION CONTACT:
William Parham at (410) 786-4669.

SUPPLEMENTARY INFORMATION:
Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520), federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. The term “collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires federal agencies to publish a 30-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, CMS is publishing this notice that summarizes the following proposed collection(s) of information for public comment:
1. Type of Information Collection Request: Revision of a currently approved collection; Title of Information Collection: Laboratory Personnel Report (CLIA) and Supporting Regulations; Use: The information collected on this survey form is used in the administrative pursuit of the Congressionally-mandated program with regard to regulation of laboratories participating in CLIA. The surveyor will provide the laboratory with the CMS-209 form. While the surveyor performs other aspects of the survey, the laboratory will complete the CMS-209 by recording the personnel data needed to support their compliance with the personnel requirements of CLIA. For this submission, we are making minor revisions to the collection instrument. We revised the instructions for clarity and removed the references to specific regulations. Form Number: CMS-209 (OMB control number 0938-0151); Frequency: Biennially; Affected Public: Private Sector—State, Local, or Tribal Governments; and Federal Government; Number of Respondents: 16,404; Total Annual Responses: 8,202; Total Annual Hours: 4,101. (For policy questions regarding this collection contact Penny Keller at 410-786-2035.)
2. Type of Information Collection Request: Reinstatement with change of a previously approved collection; Title of Information Collection: End Stage Renal Disease (ESRD) Conditions for Coverage and Supporting Regulations; Use: The Centers for Medicare and Medicaid Services (CMS) is requesting reinstatement of OMB Control number 0938-0386 (CMS-R-52) in compliance with the Paperwork Reduction Act (PRA). This package applies to existing Medicare End-stage Renal Disease (ESRD) conditions for coverage (CfCs) at 42 CFR 494. Section 299I of the Social Security Amendments of 1972 (Pub. L. 92-603) originally extended Medicare coverage to insured individuals, their spouses, and their dependent children with ESRD who require dialysis or transplantation. Subsequently, the ESRD Amendments of 1978 (Pub. L. 95-292) amended title XVIII of the Social Security Act (the Act) by adding section 1881. Section 1881(b)(1) of the Act authorizes the Secretary to prescribe health and safety requirements (known as conditions for coverage) that a facility providing dialysis and transplantation services to patients must meet to qualify for Medicare reimbursement. Final regulations were published June 3, 1976. Subsequent to the publication of the final regulations, the ESRD Amendments of 1978 were enacted to amend title XVIII of the Act to include section 1881(c). This section establishes ESRD network areas and Network organizations to assure the effective and efficient administration of ESRD program benefits. The requirements from section 1881(b) and (c) are implemented in regulations at 42 CFR part 405, subpart U, Conditions for Coverage for dialysis facilities.
On April 7, 1986, the Consolidated Omnibus Budget Reconciliation Act of 1975 (COBRA) (P.L. 99-272) was enacted which requires the Secretary to maintain renal disease Network organizations as authorized under section 1881(c) of the Act, and not merge the Network organizations into other organizations or entities. On April 15, 1986, we published a notice of proposed rulemaking to implement section 9214 of Public Law 99-272. A final rule (HSQ-115) was published August 26, 1986, which included information collection requirements at § 405.2112(e). This rule revised the requirements in regulations pertaining to the ESRD networks and organizations and establishes new, more efficient Network organizations.
Revisions resulting from two additional rules: HSQ-137—ESRD: Responsibilities of Network Organizations, published January 21, 1988; and BERC-434—Medicare Program: Standards for the Reuse of Hemodialyzer Filters and Other Dialysis Supplies, published October 2, 1987, are also included. HSQ-137-ESRD approved information collection requirements at §§ 405.2112(f) and (j). BERC-434 approved information collection requirements stemming from the following historical sections of the CFR including §§ 405.2136(b), 405.2138(a), 405.2139(a), and 405.2140(b) and (c).
Major revisions to the CFR established new ESRD CfCs at 42 CFR 494 issued in a final rule, “ Medicare and Medicaid Programs; Conditions for Coverage for End-Stage Renal Disease Facilities, ” published on April 15, 2008 (CMS-3818-F). This rule modified, removed, added, and redesigned CfCs that dialysis facilities must meet to be certified under the Medicare program. This rule approved information collection requirements at §§ 494.30, 494.40, 494.50, 494.60, 494.70, 494.80, 494.90, 494.100, 494.110, 494.120, 494.150, 494.170, and 494.180.
An additional revision to the ESRD CfCs at 42 CFR 494 was precipitated by CMS-3818-F at 414.330(a)(2)(iii)(C). The burden to ESRD home dialysis suppliers associated with this requirement would be the time and effort necessary to collect all data for each patient receiving home dialysis care with respect to services and items furnished. However, the payment method that covered these suppliers was eliminated in 2011 and there are no longer any such entities. See 42 CFR parts 410, 413 and 414 Medicare Program; End-Stage Renal Disease Prospective Payment System; Final Rule and Proposed Rule at the following link Federal Register
https://www.govinfo.gov/content/pkg/FR-2010-08-12/pdf/2010-18466.pdf. Therefore, there are no actual costs associated with this requirement; we removed it from this package.
An additional revision to the ESRD CfCs at 42 CFR 494 was precipitated by interim final rule, “ Medicare Program; Conditions for Coverage for End-Stage Renal Disease Facilities-Third Party Payment, ” published on December 14, 2016 (CMS-3337-IFC). This rule established new requirements for Medicare-certified dialysis facilities that make payments of premiums for individual market health plans. This interim final rule established additional burden associated with §§ 494.70(c) and 494.180(k); these were quantified in the preceding information collection which expired in 2024 (OMB control number 0938-0386). Since these regulations were not finalized due to litigation, they are no longer in effect. Therefore, we took out these sections from this package as they do not impose any burden.
An additional revision to the ESRD CfCs at 42 CFR 494 was precipitated by final rule, “ Medicare and Medicaid Programs; Emergency Preparedness Requirements for Medicare and Medicaid Participating Providers and Suppliers, ” published September 16, 2016 (CMS-3178-F). This rule established the creation and maintenance of an Emergency Preparedness Plan at 494.62(a), an Emergency Preparedness Policies and Procedures document at 494.62(b), an Emergency Preparedness Communication Plan at 494.62(c), a training program 494.62(d), and documentation of training exercises 494.62(e). These information collections are in separate package, OMB Control number 0938-1325.
On July 5, 2024, revisions to the CfC were proposed in “ Medicare Program; End-Stage Renal Disease Prospective Payment System, Payment for Renal Dialysis Services Furnished to Individuals with Acute Kidney Injury, Conditions for Coverage for End-Stage Renal Disease Facilities, End-Stage Renal Disease Quality Incentive Program, and End-Stage Renal Disease Treatment Choices Model, ” (CMS-1805-P). This rule proposed to expand coverage of home dialysis services to patients with acute kidney injury (AKI). Since the ESRD CfCs apply to dialysis facilities, not to people with ESRD, this rule proposes to revise language in the CfCs to allow beneficiaries with AKI to utilize home dialysis. Specifically, we refer to facilities abiding by the ESRD CfCs as `dialysis facilities' opposed to `ESRD facilities and all patients seeking services from dialysis facilities as `patients' rather than `ESRD patients.' There is no ICR burden associated with these changes however we made confirming changes to the language in this package.
The CfCs are used by Federal (CMS), State surveyors (employed by State survey agencies), or CMS authorized accrediting organizations as a basis for determining whether a dialysis facility qualifies for approval or re-approval under Medicare. Surveyors make an in-person visit to the dialysis facility to perform the complete survey.
The preceding information collection, which expired on March 31, 2024, estimated the total annual hourly burden as 1,260,491 hours at a cost of $64,839,657. We revise this to 800,621 hours at a cost of $49,638,502. The reduction in hours and cost is largely due to removing the burden estimates that no longer apply. Form Number: CMS-R-52 (OMB control number: 0938-0386); Frequency: Annually; Affected Public: Private sector—Business or other for-profit; Number of Respondents: 8,048; Total Annual Responses: 215,591; Total Annual Hours: 800,621 (For policy questions regarding this collection contact Claudia Molinar at 410-786-8445.)
3. Type of Information Collection Request: Reinstatement without change of a previously approved collection; Title of Information Collection: Hospice Information for Medicare Part D Plans; Use: The Social Security Act in section 1861(dd) and Federal regulations in 42 CFR 418.106 and § 418.202(f) require hospice programs to provide individuals under hospice care with drugs and biologicals related to the palliation and management of the terminal illness as defined in the hospice plan of care. Medicare payment is made to the hospice for each day an eligible beneficiary is under the hospice's care, regardless of the amount of services provided on any given day. Because hospice care is a Medicare Part A benefit, drugs provided by the hospice and covered under the Medicare payment to the hospice program are not covered under Part D.
The form would be completed by the prescriber or the beneficiary's hospice, or if the prescriber or hospice provides the information verbally to the Part D sponsor, the form would be completed by the sponsor. Information provided on the form would be used by the Part D sponsor to establish coverage of the drug under Medicare Part D. Per statute, drugs that are necessary for the palliation and management of the terminal illness and related conditions are not eligible for payment under Part D. The standard form provides a vehicle for the hospice provider, prescriber or sponsor to document that the drug prescribed is “unrelated” to the terminal illness and related conditions. It also gives a hospice organization the option to communicate a beneficiary's change in hospice status and/care plan to Part D sponsors. Form Number: CMS-10538 (OMB control number: 0938-1296); Frequency: Yearly; Affected Public: Private Sector (business or other for-profits); Number of Respondents: 319; Number of Responses: 57,027; Total Annual Hours: 2,329. (For policy questions regarding this collection, contact Chad Buskirk at (410) 786-1630 or chad.buskirk@cms.hhs.gov. )
4. Type of Information Collection Request: Reinstatement without change of a previously approved collection; Title of Information Collection: Part D Coordination of Benefits Data; Use: Sections 1860D-23 and 1860D-24 of the Act require the Secretary to establish requirements for prescription drug plans to promote effective coordination between Part D plans and SPAPs and other payers. These Part D Coordination of Benefits (COB) requirements have been codified into the Code of Federal Regulations at 42 CFR 423.464. In particular, CMS' requirements relate to the following elements: (1) enrollment file sharing; (2) claims processing and payment; (3) claims reconciliation reports; (4) application of the protections against high out-of-pocket expenditures by tracking TrOOP expenditures; and (5) other processes that the Secretary determines.
This information collection request assists CMS, pharmacists, Part D plans, and other payers coordinate prescription drug benefits at the point-of-sale and track beneficiary True out-of-pocket (TrOOP) expenditures using the Part D Transaction Facilitator (PDTF). Form Number: CMS-10171 (OMB control number: 0938-0978); Frequency: Yearly; Affected Public: State, Local, or Tribal Government; Number of Respondents: 67,043; Total Annual Responses: 935,730,342; Total Annual Hours: 1,011,740. (For policy questions regarding this collection contact Chad Buskirk at 410-786-1630 or chad.buskirk@cms.hhs.gov. )
5. Type of Information Collection Request: Revision of a currently approved collection; Title of Information Collection: Requirements Related to Surprise Billing: Qualifying Payment Amount, Notice and Consent, Disclosure on Patient Protections Against Balance Billing, and State Law Opt-in; Use: On December 27, 2020, the Consolidated Appropriations Act, 2021 (Pub. L. 116-260), which included the No Surprises Act, was signed into law. The No Surprises Act provides Federal protections against surprise billing and limits out-of-network cost sharing under many of the circumstances in which surprise medical bills arise most frequently. The July 13, 2021 interim final rules “Requirements Related to Surprise Billing; Part I” (86 FR 36872, July 2021 interim final rules) issued by the Department of Health and Human Services, the Department of Labor, the Department of the Treasury, and the Office of Personnel Management, implement provisions of the No Surprises Act that apply to group health plans, health insurance issuers offering group or individual health insurance coverage, and carriers in the Federal Employees Health Benefits (FEHB) Program that provide protections against balance billing and out-of-network cost sharing with respect to emergency services, non-emergency services furnished by nonparticipating providers related to patient visits to certain types of participating health care facilities, and services furnished by nonparticipating providers of air ambulance services. The July 2021 interim final rules prohibit nonparticipating providers, emergency facilities, and providers of air ambulance services from balance billing participants, beneficiaries, and enrollees in certain situations unless they satisfy certain notice and consent requirements. The No Surprises Act and the July 2021 interim final rules require group health plans and issuers of health insurance coverage to provide information about qualifying payment amounts (QPAs) to nonparticipating providers and facilities and to provide disclosures on patient protections against balance billing to participants, beneficiaries and enrollees. Self-insured plans opting in to a specified State law are required to provide a disclosure to participants. Certain nonparticipating providers and nonparticipating emergency facilities may provide participants, beneficiaries, and enrollees with notice and obtain their consent to waive balance billing protections, provided certain requirements are met. In addition, certain providers and facilities are required to provide disclosures on patient protections against balance billing to participants, beneficiaries and enrollees. The No Surprises Act requires the Secretary of HHS to audit no more than 25 group health plans and health insurance issuers offering group or individual health insurance coverage annually, and permits additional audits based on complaints, to ensure that such plans and coverage are in compliance with the requirement of applying a QPA and that the QPA applied satisfies the definition under the No Surprises Act with respect to the year involved. Form Number: CMS-10780 (OMB control number: 0938-1401); Frequency: On Occasion; Affected Public: Individuals, State, Local, or Tribal Governments, Private Sector; Number of Respondents: 2,477,197; Total Annual Responses: 85,148,199; Total Annual Hours: 6,006,654. (For policy questions regarding this collection, contact Russell Tipps at 667-290-9640.)
William N. Parham, III,

Director, Division of Information Collections and Regulatory Impacts, Office of Strategic Operations and Regulatory Affairs.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-E-3272; FDA-2023-E-3273; FDA-2023-E-3274; FDA-2023-E-3276; FDA-2023-E-3296; and FDA-2023-E-3297]
Determination of Regulatory Review Period for Purposes of Patent Extension; SKYCLARYS

AGENCY:
Food and Drug Administration, HHS.

ACTION:
Notice.

SUMMARY:
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for SKYCLARYS and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.

DATES:
Anyone with knowledge that any of the dates as published (see SUPPLEMENTARY INFORMATION ) are incorrect must submit either electronic or written comments and ask for a redetermination by July 11, 2025. Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period by November 10, 2025. See “Petitions” in the SUPPLEMENTARY INFORMATION section for more information.

ADDRESSES:
You may submit comments as follows. Please note that late, untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of July 11, 2025. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are received on or before that date.

Electronic Submissions
Submit electronic comments in the following way:
• Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov.
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).

Written/Paper Submissions
Submit written/paper submissions as follows:
• Mail/Hand Delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
Instructions: All submissions received must include the Docket Nos. FDA-2023-E-3272; FDA-2023-E-3273; FDA-2023-E-3274; FDA-2023-E-3276; FDA-2023-E-3296; and FDA-2023-E-3297 for “Determination of Regulatory Review Period for Purposes of Patent Extension; SKYCLARYS.” Received comments, those filed in a timely manner (see ADDRESSES ), will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
• Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with § 10.20 (21 CFR 10.20) and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500.

FOR FURTHER INFORMATION CONTACT:
Beverly Friedman or Jack Dan, Office of Regulatory Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6200, Silver Spring, MD 20993, 301-796-3600.

SUPPLEMENTARY INFORMATION:

I. Background
The Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug and Patent Term Restoration Act (Pub. L. 100-670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug or biologic product, animal drug product, medical device, food additive, or color additive) was subject to regulatory review by FDA before the item was marketed. Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.
A regulatory review period consists of two periods of time: a testing phase and an approval phase. For human drug products, the testing phase begins when the exemption to permit the clinical investigations of the drug becomes effective and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the human drug product and continues until FDA grants permission to market the drug product. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of USPTO may award (for example, half the testing phase must be subtracted as well as any time that may have occurred before the patent was issued), FDA's determination of the length of a regulatory review period for a human drug product will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(1)(B).
FDA has approved for marketing the human drug product, SKYCLARYS (omaveloxolone). SKYCLARYS is indicated for the treatment of Friedreich's ataxia in adults and adolescents aged 16 years and older. Subsequent to this approval, the USPTO received patent term restoration applications for SKYCLARYS (U.S. Patent Nos. 8,124,799; 8,440,854; 8,993,640; 9,670,147; 9,701,709; and 11,091,430) from Reata Pharmaceuticals, Inc., and the USPTO requested FDA's assistance in determining the patents' eligibility for patent term restoration. In a letter dated January 30, 2024, FDA advised the USPTO that this human biological product had undergone a regulatory review period and that the approval of SKYCLARYS represented the first permitted commercial marketing or use of the product. Thereafter, the USPTO requested that FDA determine the product's regulatory review period.

II. Determination of Regulatory Review Period
FDA has determined that the applicable regulatory review period for SKYCLARYS is 3,450 days. Of this time, 3,114 days occurred during the testing phase of the regulatory review period, while 336 days occurred during the approval phase. These periods of time were derived from the following dates:
1. The date an exemption under section 505(i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(i)) became effective: September 20, 2013. FDA has verified the applicant's claim that the date the investigational new drug application became effective was on September 20, 2013.
2. The date the application was initially submitted with respect to the human drug product under section 505 of the FD&C Act: March 30, 2022. FDA has verified the applicant's claim that the new drug application (NDA) for SKYCLARYS (NDA 216718) was initially submitted on March 30, 2022.
3. The date the application was approved: February 28, 2023. FDA has verified the applicant's claim that NDA 216718 was approved on February 28, 2023.
This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the USPTO applies several statutory limitations in its calculations of the actual period for patent extension. In its applications for patent extension, this applicant seeks 449 days; 1,198 days; 1,215 days; 1,406 days; or 1,826 days of patent term extension.

III. Petitions
Anyone with knowledge that any of the dates as published are incorrect may submit either electronic or written comments and, under 21 CFR 60.24, ask for a redetermination (see DATES ). Furthermore, as specified in § 60.30 (21 CFR 60.30), any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period. To meet its burden, the petition must comply with all the requirements of § 60.30, including but not limited to: must be timely (see DATES ), must be filed in accordance with § 10.20, must contain sufficient facts to merit an FDA investigation, and must certify that a true and complete copy of the petition has been served upon the patent applicant. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-42, 1984.) Petitions should be in the format specified in 21 CFR 10.30.
Submit petitions electronically to https://www.regulations.gov at Docket No. FDA-2013-S-0610. Submit written petitions (two copies are required) to the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
Dated: May 6, 2025.
Grace R. Graham,

Deputy Commissioner for Policy, Legislation, and International Affairs.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-E-0192]
Determination of Regulatory Review Period for Purposes of Patent Extension; LITFULO

AGENCY:
Food and Drug Administration, HHS.

ACTION:
Notice.

SUMMARY:
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for LITFULO and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.

DATES:
Anyone with knowledge that any of the dates as published (see SUPPLEMENTARY INFORMATION ) are incorrect may submit either electronic or written comments and ask for a redetermination by July 11, 2025. Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period by November 10, 2025. See “Petitions” in the SUPPLEMENTARY INFORMATION section for more information.

ADDRESSES:
You may submit comments as follows. Please note that late, untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of July 11, 2025. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are received on or before that date.

Electronic Submissions
Submit electronic comments in the following way:
• Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov.
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).

Written/Paper Submissions
Submit written/paper submissions as follows:
• Mail/Hand Delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
Instructions: All submissions received must include the Docket No. FDA-2024-E-0192 for “Determination of Regulatory Review Period for Purposes of Patent Extension; LITFULO.” Received comments, those filed in a timely manner (see ADDRESSES ), will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
• Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with § 10.20 (21 CFR 10.20) and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500.

FOR FURTHER INFORMATION CONTACT:
Beverly Friedman or Jack Dan, Office of Regulatory Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6200, Silver Spring, MD 20993, 301-796-3600.

SUPPLEMENTARY INFORMATION:

I. Background
The Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug and Patent Term Restoration Act (Pub. L. 100-670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug or biological product, animal drug product, medical device, food additive, or color additive) was subject to regulatory review by FDA before the item was marketed. Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.
A regulatory review period consists of two periods of time: a testing phase and an approval phase. For human drug products, the testing phase begins when the exemption to permit the clinical investigations of the drug becomes effective and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the human drug product and continues until FDA grants permission to market the drug product. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of USPTO may award (for example, half the testing phase must be subtracted as well as any time that may have occurred before the patent was issued), FDA's determination of the length of a regulatory review period for a human drug product will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(1)(B).
FDA has approved for marketing the human drug product, LITFULO (ritlecitinib tosylate) indicated for treatment of severe alopecia areata in adults and adolescents 12 years and older. Subsequent to this approval, the USPTO received a patent term restoration application for LITFULO (U.S. Patent No. 9,617,258) from Pfizer Inc., and the USPTO requested FDA's assistance in determining the patent's eligibility for patent term restoration. In a letter dated January 30, 2024, FDA advised the USPTO that this human drug product had undergone a regulatory review period and that the approval of LITFULO represented the first permitted commercial marketing or use of the product. Thereafter, the USPTO requested that FDA determine the product's regulatory review period.

II. Determination of Regulatory Review Period
FDA has determined that the applicable regulatory review period for LITFULO is 2,434 days. Of this time, 2,068 days occurred during the testing phase of the regulatory review period, while 366 days occurred during the approval phase. These periods of time were derived from the following dates:
1. The date an exemption under section 505(i) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(i)) became effective: October 26, 2016. The applicant claims November 2, 2016, as the date the investigational new drug application (IND) became effective. However, FDA records indicate that the IND effective date was October 26, 2016, which was 30 days after FDA receipt of an earlier IND.
2. The date the application was initially submitted with respect to the human drug product under section 505 of the FD&C Act: June 24, 2022. FDA has verified the applicant's claim that the new drug application (NDA) for LITFULO (NDA 215830) was initially submitted on June 24, 2022.
3. The date the application was approved: June 23, 2023, 5:04 p.m. FDA has verified the applicant's claim that NDA 215830 was approved on June 23, 2023.
This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the USPTO applies several statutory limitations in its calculations of the actual period for patent extension. In its application(s) for patent extension, this applicant seeks 934 days of patent term extension.

III. Petitions
Anyone with knowledge that any of the dates as published are incorrect may submit either electronic or written comments and, under 21 CFR 60.24, ask for a redetermination (see DATES ). Furthermore, as specified in § 60.30 (21 CFR 60.30), any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period. To meet its burden, the petition must comply with all the requirements of § 60.30, including but not limited to: must be timely (see DATES ), must be filed in accordance with § 10.20, must contain sufficient facts to merit an FDA investigation, and must certify that a true and complete copy of the petition has been served upon the patent applicant. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-42, 1984.) Petitions should be in the format specified in 21 CFR 10.30.
Submit petitions electronically to http://www.regulations.gov at Docket No. FDA-2013-S-0610. Submit written petitions (two copies are required) to the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
Dated: May 6, 2025.
Grace R. Graham,

Deputy Commissioner for Policy, Legislation, and International Affairs.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA-2024-E-0201, FDA-2024-E-0202, and FDA-2024-E-0203]
Determination of Regulatory Review Period for Purposes of Patent Extension; NGENLA

AGENCY:
Food and Drug Administration, HHS.

ACTION:
Notice.

SUMMARY:
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for NGENLA and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human biological product.

DATES:
Anyone with knowledge that any of the dates as published (see SUPPLEMENTARY INFORMATION ) are incorrect must submit either electronic or written comments and ask for a redetermination by July 11, 2025. Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period by November 10, 2025. See “Petitions” in the SUPPLEMENTARY INFORMATION section for more information.

ADDRESSES:
You may submit comments as follows. Please note that late, untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of July 11, 2025. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are received on or before that date.

Electronic Submissions
Submit electronic comments in the following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov.
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).

Written/Paper Submissions
Submit written/paper submissions as follows:
• Mail/Hand Delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
Instructions: All submissions received must include the Docket Nos. FDA-2024-E-0201, FDA-2024-E-0202, and FDA-2024-E-0203 for “Determination of Regulatory Review Period for Purposes of Patent Extension; NGENLA.” Received comments, those filed in a timely manner (see ADDRESSES ), will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
• Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with § 10.20 (21 CFR 10.20) and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500.

FOR FURTHER INFORMATION CONTACT:
Beverly Friedman or Jack Dan, Office of Regulatory Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6200, Silver Spring, MD 20993, 301-796-3600.

SUPPLEMENTARY INFORMATION:

I. Background
The Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug and Patent Term Restoration Act (Pub. L. 100-670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug or biologic product, animal drug product, medical device, food additive, or color additive) was subject to regulatory review by FDA before the item was marketed. Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.
A regulatory review period consists of two periods of time: a testing phase and an approval phase. For human biological products, the testing phase begins when the exemption to permit the clinical investigations of the biological product becomes effective and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the human biological product and continues until FDA grants permission to market the biological product. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of USPTO may award (for example, half the testing phase must be subtracted as well as any time that may have occurred before the patent was issued), FDA's determination of the length of a regulatory review period for a human biological product will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(1)(B).
FDA has approved for marketing the human biologic product NGENLA (somatrogon-ghla). NGENLA is indicated for treatment of pediatric patients aged 3 years and older who have growth failure due to inadequate secretion of endogenous growth hormone. Subsequent to this approval, the USPTO received patent term restoration applications for NGENLA (U.S. Patent Nos. 7,553,941; 8,304,386; 11,197,915) from OPKO Biologics Ltd., and the USPTO requested FDA's assistance in determining the patents' eligibility for patent term restoration. In a letter dated February 6, 2024, FDA advised the USPTO that this human biological product had undergone a regulatory review period and that the approval of NGENLA represented the first permitted commercial marketing or use of the product. Thereafter, the USPTO requested that FDA determine the product's regulatory review period.

II. Determination of Regulatory Review Period
FDA has determined that the applicable regulatory review period for NGENLA is 4,698 days. Of this time, 3,718 days occurred during the testing phase of the regulatory review period, while 980 days occurred during the approval phase. These periods of time were derived from the following dates:
1. The date an exemption under section 505(i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(i)) became effective: August 19, 2010. FDA has verified the applicant's claim that the date the investigational new drug application became effective was on August 19, 2010.
2. The date the application was initially submitted with respect to the human biological product under section 351 of the Public Health Service Act (42 U.S.C. 262): October 22, 2020. FDA has verified the applicant's claim that the biologics license application (BLA) for NGENLA (BLA B761184) was initially submitted on October 22, 2020.
3. The date the application was approved: June 27, 2023, 5:37 p.m. FDA has verified the applicant's claim that BLA B761184 was approved on June 27, 2023.
This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the USPTO applies several statutory limitations in its calculations of the actual period for patent extension. In its applications for patent extension, this applicant seeks 560 days or 1,826 days of patent term extension.

III. Petitions
Anyone with knowledge that any of the dates as published are incorrect may submit either electronic or written comments and, under 21 CFR 60.24, ask for a redetermination (see DATES ). Furthermore, as specified in § 60.30 (21 CFR 60.30), any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period. To meet its burden, the petition must comply with all the requirements of § 60.30, including but not limited to: must be timely (see DATES ), must be filed in accordance with § 10.20, must contain sufficient facts to merit an FDA investigation, and must certify that a true and complete copy of the petition has been served upon the patent applicant. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-42, 1984.) Petitions should be in the format specified in 21 CFR 10.30.
Submit petitions electronically to https://www.regulations.gov at Docket Nos. FDA-2013-S-0610. Submit written petitions (two copies are required) to the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
Dated: May 6, 2025.
Grace R. Graham,

Deputy Commissioner for Policy, Legislation, and International Affairs.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-E-3265]
Determination of Regulatory Review Period for Purposes of Patent Extension; SUNLENCA

AGENCY:
Food and Drug Administration, HHS.

ACTION:
Notice.

SUMMARY:
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for SUNLENCA and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.

DATES:
Anyone with knowledge that any of the dates as published (see SUPPLEMENTARY INFORMATION ) are incorrect may submit either electronic or written comments and ask for a redetermination by July 11, 2025. Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period by November 10, 2025. See “Petitions” in the SUPPLEMENTARY INFORMATION section for more information.

ADDRESSES:
You may submit comments as follows. Please note that late, untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of July 11, 2025. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are received on or before that date.

Electronic Submissions
Submit electronic comments in the following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov.
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).

Written/Paper Submissions
Submit written/paper submissions as follows:
• Mail/Hand Delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
Instructions: All submissions received must include the Docket No. FDA-2023-E-3265 for “Determination of Regulatory Review Period for Purposes of Patent Extension; SUNLENCA.” Received comments, those filed in a timely manner (see ADDRESSES ), will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
• Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with § 10.20 (21 CFR 10.20) and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500.

FOR FURTHER INFORMATION CONTACT:
Beverly Friedman or Jack Dan, Office of Regulatory Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6200, Silver Spring, MD 20993, 301-796-3600.

SUPPLEMENTARY INFORMATION:

I. Background
The Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug and Patent Term Restoration Act (Pub. L. 100-670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug or biological product, animal drug product, medical device, food additive, or color additive) was subject to regulatory review by FDA before the item was marketed. Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.
A regulatory review period consists of two periods of time: a testing phase and an approval phase. For human drug products, the testing phase begins when the exemption to permit the clinical investigations of the drug becomes effective and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the human drug product and continues until FDA grants permission to market the drug product. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of USPTO may award (for example, half the testing phase must be subtracted as well as any time that may have occurred before the patent was issued), FDA's determination of the length of a regulatory review period for a human drug product will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(1)(B).
FDA has approved for marketing the human drug product SUNLENCA (lenacapavir sodium). SUNLENCA is indicated for the treatment of HIV-1 infection in heavily treatment-experienced adults with multidrug resistant HIV-1 infection failing their current antiretroviral regimen due to resistance, intolerance, or safety considerations. Subsequent to this approval, the USPTO received a patent term restoration application for SUNLENCA (U.S. Patent No. 9,951,043) from Gilead Sciences, Inc. and the USPTO requested FDA's assistance in determining the patent's eligibility for patent term restoration. In a letter dated January 30, 2024, FDA advised the USPTO that this human drug product had undergone a regulatory review period and that the approval of SUNLENCA represented the first permitted commercial marketing or use of the product. Thereafter, the USPTO requested that FDA determine the product's regulatory review period.

II. Determination of Regulatory Review Period
FDA has determined that the applicable regulatory review period for SUNLENCA is 1,808 days. Of this time, 1,265 days occurred during the testing phase of the regulatory review period, while 543 days occurred during the approval phase. These periods of time were derived from the following dates:
1. The date an exemption under section 505(i) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(i)) became effective: January 11, 2018. FDA has verified the applicant's claim that the date the investigational new drug application became effective was on January 11, 2018.
2. The date the application was initially submitted with respect to the human drug product under section 505 of the FD&C: June 28, 2021. FDA has verified the applicant's claim that the new drug application (NDA) for SUNLENCA (NDA 215974) was initially submitted on June 28, 2021.
3. The date the application was approved: December 22, 2022. FDA has verified the applicant's claim that NDA 215974 was approved on December 22, 2022.
This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the USPTO applies several statutory limitations in its calculations of the actual period for patent extension. In its application for patent extension, this applicant seeks 1,028 days of patent term extension.

III. Petitions
Anyone with knowledge that any of the dates as published are incorrect may submit either electronic or written comments and, under 21 CFR 60.24, ask for a redetermination (see DATES ). Furthermore, as specified in § 60.30 (21 CFR 60.30), any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period. To meet its burden, the petition must comply with all the requirements of § 60.30, including but not limited to: must be timely (see DATES ), must be filed in accordance with § 10.20, must contain sufficient facts to merit an FDA investigation, and must certify that a true and complete copy of the petition has been served upon the patent applicant. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-42, 1984.) Petitions should be in the format specified in 21 CFR 10.30.
Submit petitions electronically to https://www.regulations.gov at Docket No. FDA-2013-S-0610. Submit written petitions (two copies are required) to the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
Dated: May 6, 2025.
Grace R. Graham,

Deputy Commissioner for Policy, Legislation, and International Affairs.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-E-3267]
Determination of Regulatory Review Period for Purposes of Patent Extension; JAYPIRCA

AGENCY:
Food and Drug Administration, HHS.

ACTION:
Notice.

SUMMARY:
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for JAYPIRCA and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.

DATES:
Anyone with knowledge that any of the dates as published (see SUPPLEMENTARY INFORMATION ) are incorrect may submit either electronic or written comments and ask for a redetermination by July 11, 2025. Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period by November 10, 2025. See “Petitions” in the SUPPLEMENTARY INFORMATION section for more information.

ADDRESSES:
You may submit comments as follows. Please note that late, untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of July 11, 2025. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are received on or before that date.

Electronic Submissions
Submit electronic comments in the following way:
• Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov.
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).

Written/Paper Submissions
Submit written/paper submissions as follows:
• Mail/Hand Delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
Instructions: All submissions received must include the Docket No. FDA-2023-E-3267 for “Determination of Regulatory Review Period for Purposes of Patent Extension; JAYPIRCA.” Received comments, those filed in a timely manner (see ADDRESSES ), will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
• Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with § 10.20 (21 CFR 10.20) and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500.

FOR FURTHER INFORMATION CONTACT:
Beverly Friedman or Jack Dan, Office of Regulatory Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6200, Silver Spring, MD 20993, 301-796-3600.

SUPPLEMENTARY INFORMATION:

I. Background
The Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug and Patent Term Restoration Act (Pub. L. 100-670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug or biological product, animal drug product, medical device, food additive, or color additive) was subject to regulatory review by FDA before the item was marketed. Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.
A regulatory review period consists of two periods of time: a testing phase and an approval phase. For human drug products, the testing phase begins when the exemption to permit the clinical investigations of the drug becomes effective and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the human drug product and continues until FDA grants permission to market the drug product. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of USPTO may award (for example, half the testing phase must be subtracted as well as any time that may have occurred before the patent was issued), FDA's determination of the length of a regulatory review period for a human drug product will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(1)(B).
FDA has approved for marketing the human drug product, JAYPIRCA (pirtobrutinib) indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma after at least two lines of systemic therapy, including a Bruton tyrosine kinase inhibitor. This indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. Subsequent to this approval, the USPTO received a patent term restoration application for JAYPIRCA (U.S. Patent No. 10,342,780) from Loxo Oncology, Inc. and the USPTO requested FDA's assistance in determining the patent's eligibility for patent term restoration. In a letter dated January 30, 2024, FDA advised the USPTO that this human drug product had undergone a regulatory review period and that the approval of JAYPIRCA represented the first permitted commercial marketing or use of the product. Thereafter, the USPTO requested that FDA determine the product's regulatory review period.

II. Determination of Regulatory Review Period
FDA has determined that the applicable regulatory review period for JAYPIRCA is 1,584 days. Of this time, 1,338 days occurred during the testing phase of the regulatory review period, while 246 days occurred during the approval phase. These periods of time were derived from the following dates:
1. The date an exemption under section 505(i) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(i)) became effective: September 28, 2018. FDA has verified the applicant's claim that the date the investigational new drug application became effective was on September 28, 2018.
2. The date the application was initially submitted with respect to the human drug product under section 505 of the FD&C Act: May 27, 2022. The applicant claims December 10, 2021, as the date the new drug application (NDA) for JAYPIRCA (NDA 216059) was initially submitted. However, according to FDA records, NDA 216059 was submitted on May 27, 2022 when FDA received a complete application.
3. The date the application was approved: January 27, 2023. FDA has verified the applicant's claim that NDA 216059 was approved on January 27, 2023.
This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the USPTO applies several statutory limitations in its calculations of the actual period for patent extension. In its application for patent extension, this applicant seeks 42 days of patent term extension.

III. Petitions
Anyone with knowledge that any of the dates as published are incorrect may submit either electronic or written comments and, under 21 CFR 60.24, ask for a redetermination (see DATES ). Furthermore, as specified in § 60.30 (21 CFR 60.30), any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period. To meet its burden, the petition must comply with all the requirements of § 60.30, including but not limited to: must be timely (see DATES ), must be filed in accordance with § 10.20, must contain sufficient facts to merit an FDA investigation, and must certify that a true and complete copy of the petition has been served upon the patent applicant. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-42, 1984.) Petitions should be in the format specified in 21 CFR 10.30.
Submit petitions electronically to https://www.regulations.gov at Docket No. FDA-2013-S-0610. Submit written petitions (two copies are required) to the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
Dated: May 6, 2025.
Grace R. Graham,

Deputy Commissioner for Policy, Legislation, and International Affairs.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-E-0210]
Determination of Regulatory Review Period for Purposes of Patent Extension; ELREXFIO

AGENCY:
Food and Drug Administration, HHS.

ACTION:
Notice.

SUMMARY:
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for ELREXFIO and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human biological product.

DATES:
Anyone with knowledge that any of the dates as published (see SUPPLEMENTARY INFORMATION ) are incorrect must submit either electronic or written comments and ask for a redetermination by July 11, 2025. Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period by November 10, 2025. See “Petitions” in the SUPPLEMENTARY INFORMATION section for more information.

ADDRESSES:
You may submit comments as follows. Please note that late, untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of July 11, 2025. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are received on or before that date.

Electronic Submissions
Submit electronic comments in the following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov.
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).

Written/Paper Submissions
Submit written/paper submissions as follows:
• Mail/Hand Delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
Instructions: All submissions received must include the Docket No. FDA-2024-E-0210 for “Determination of Regulatory Review Period for Purposes of Patent Extension; ELREXFIO.” Received comments, those filed in a timely manner (see ADDRESSES ), will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
• Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with § 10.20 (21 CFR 10.20) and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500.

FOR FURTHER INFORMATION CONTACT:
Beverly Friedman or Jack Dan, Office of Regulatory Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6200, Silver Spring, MD 20993, 301-796-3600.

SUPPLEMENTARY INFORMATION:

I. Background
The Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug and Patent Term Restoration Act (Pub. L. 100-670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug or biologic product, animal drug product, medical device, food additive, or color additive) was subject to regulatory review by FDA before the item was marketed. Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.
A regulatory review period consists of two periods of time: a testing phase and an approval phase. For human biological products, the testing phase begins when the exemption to permit the clinical investigations of the biological product becomes effective and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the human biological product and continues until FDA grants permission to market the biological product. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of USPTO may award (for example, half the testing phase must be subtracted as well as any time that may have occurred before the patent was issued), FDA's determination of the length of a regulatory review period for a human biological product will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(1)(B).
FDA has approved for marketing the human biologic product ELREXFIO (elranatamab-bcmm). ELREXFIO is indicated for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody. This indication is approved under accelerated approval based on response rate and durability of response. Continued approval for this indication may be contingent upon verification of clinical benefit in a confirmatory trial. Subsequent to this approval, the USPTO received patent term restoration applications for ELREXFIO (U.S. Patent Nos. 9,969,809 and 11,155,630) from Pfizer Inc., and the USPTO requested FDA's assistance in determining the patents' eligibility for patent term restoration. In a letter dated February 7, 2024, FDA advised the USPTO that this human biological product had undergone a regulatory review period and that the approval of ELREXFIO represented the first permitted commercial marketing or use of the product. Thereafter, the USPTO requested that FDA determine the product's regulatory review period.

II. Determination of Regulatory Review Period
FDA has determined that the applicable regulatory review period for ELREXFIO is 2,149 days. Of this time, 1,910 days occurred during the testing phase of the regulatory review period, while 239 days occurred during the approval phase. These periods of time were derived from the following dates:
1. The date an exemption under section 505(i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(i)) became effective: September 27, 2017. FDA has verified the applicant's claim that the date the investigational new drug application became effective was on September 27, 2017.
2. The date the application was initially submitted with respect to the human biological product under section 351 of the Public Health Service Act (42 U.S.C. 262): December 19, 2022. FDA has verified the applicant's claim that the biologics license application (BLA) for ELREXFIO (BLA B761345) was initially submitted on December 19, 2022.
3. The date the application was approved: August 14, 2023. FDA has verified the applicant's claim that BLA B761345 was approved on August 14, 2023.
This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the USPTO applies several statutory limitations in its calculations of the actual period for patent extension. In its applications for patent extension, this applicant seeks 449 days or 502 days of patent term extension.

III. Petitions
Anyone with knowledge that any of the dates as published are incorrect may submit either electronic or written comments and, under 21 CFR 60.24, ask for a redetermination (see DATES ). Furthermore, as specified in § 60.30 (21 CFR 60.30), any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period. To meet its burden, the petition must comply with all the requirements of § 60.30, including but not limited to: must be timely (see DATES ), must be filed in accordance with § 10.20, must contain sufficient facts to merit an FDA investigation, and must certify that a true and complete copy of the petition has been served upon the patent applicant. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-42, 1984.) Petitions should be in the format specified in 21 CFR 10.30.
Submit petitions electronically to https://www.regulations.gov at Docket No. FDA-2013-S-0610. Submit written petitions (two copies are required) to the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
Dated: May 6, 2025.
Grace R. Graham,

Deputy Commissioner for Policy, Legislation, and International Affairs.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-E-3270]
Determination of Regulatory Review Period for Purposes of Patent Extension; LAMZEDE

AGENCY:
Food and Drug Administration, HHS.

ACTION:
Notice.

SUMMARY:
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for LAMZEDE and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human biological product.

DATES:
Anyone with knowledge that any of the dates as published (see SUPPLEMENTARY INFORMATION ) are incorrect must submit either electronic or written comments and ask for a redetermination by July 11, 2025. Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period by November 10, 2025. See “Petitions” in the SUPPLEMENTARY INFORMATION section for more information.

ADDRESSES:
You may submit comments as follows. Please note that late, untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of July 11, 2025. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are received on or before that date.

Electronic Submissions
Submit electronic comments in the following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov.
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).

Written/Paper Submissions
Submit written/paper submissions as follows:
• Mail/Hand Delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
Instructions: All submissions received must include the Docket No. FDA-2023-E-3270 for “Determination of Regulatory Review Period for Purposes of Patent Extension; LAMZEDE.” Received comments, those filed in a timely manner (see ADDRESSES ), will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
• Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with § 10.20 (21 CFR 10.20) and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500.

FOR FURTHER INFORMATION CONTACT:
Beverly Friedman or Jack Dan, Office of Regulatory Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6200, Silver Spring, MD 20993, 301-796-3600.

SUPPLEMENTARY INFORMATION:

I. Background
The Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug and Patent Term Restoration Act (Pub. L. 100-670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug or biologic product, animal drug product, medical device, food additive, or color additive) was subject to regulatory review by FDA before the item was marketed. Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.
A regulatory review period consists of two periods of time: a testing phase and an approval phase. For human biological products, the testing phase begins when the exemption to permit the clinical investigations of the biological product becomes effective and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the human biological product and continues until FDA grants permission to market the biological product. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of USPTO may award (for example, half the testing phase must be subtracted as well as any time that may have occurred before the patent was issued), FDA's determination of the length of a regulatory review period for a human biological product will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(1)(B).
FDA has approved for marketing the human biologic product LAMZEDE (velmanase alfa-tycv). LAMZEDE is indicated for the treatment of non-central nervous system manifestations of alpha-mannosidosis in adult and pediatric patients. Subsequent to this approval, the USPTO received a patent term restoration application for LAMZEDE (U.S. Patent No. 10,159,718) from Chiesi Farmaceutici S.p.A., and the USPTO requested FDA's assistance in determining this patent's eligibility for patent term restoration. In a letter dated January 30, 2024, FDA advised the USPTO that this human biological product had undergone a regulatory review period and that the approval of LAMZEDE represented the first permitted commercial marketing or use of the product. Thereafter, the USPTO requested that FDA determine the product's regulatory review period.

II. Determination of Regulatory Review Period
FDA has determined that the applicable regulatory review period for LAMZEDE is 1,245 days. Of this time, 1,000 days occurred during the testing phase of the regulatory review period, while 245 days occurred during the approval phase. These periods of time were derived from the following dates:
1. The date an exemption under section 505(i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(i)) became effective: September 22, 2019. FDA has verified the applicant's claim that the date the investigational new drug application became effective was on September 22, 2019.
2. The date the application was initially submitted with respect to the human biological product under section 351 of the Public Health Service Act (42 U.S.C. 262): June 17, 2022. FDA has verified the applicant's claim that the biologics license application (BLA) for LAMZEDE (BLA 761278) was initially submitted on June 17, 2022.
3. The date the application was approved: February 16, 2023. FDA has verified the applicant's claim that BLA 761278 was approved on February 16, 2023.
This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the USPTO applies several statutory limitations in its calculations of the actual period for patent extension. In its application for patent extension, this applicant seeks 745 days of patent term extension.

III. Petitions
Anyone with knowledge that any of the dates as published are incorrect may submit either electronic or written comments and, under 21 CFR 60.24, ask for a redetermination (see DATES ). Furthermore, as specified in § 60.30 (21 CFR 60.30), any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period. To meet its burden, the petition must comply with all the requirements of § 60.30, including but not limited to: must be timely (see DATES ), must be filed in accordance with § 10.20, must contain sufficient facts to merit an FDA investigation, and must certify that a true and complete copy of the petition has been served upon the patent applicant. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-42, 1984.) Petitions should be in the format specified in 21 CFR 10.30.
Submit petitions electronically to https://www.regulations.gov at Docket No. FDA-2013-S-0610. Submit written petitions (two copies are required) to the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
Dated: May 6, 2025.
Grace R. Graham,

Deputy Commissioner for Policy, Legislation, and International Affairs.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Fogarty International Center; Notice of Meeting
Pursuant to section 1009 of the Federal Advisory Committee Act, as amended, notice is hereby given of a meeting of the Fogarty International Center Advisory Board.
The meeting will be open to the public as indicated below, with attendance limited to space available. Individuals who plan to attend in-person and or view the virtual meeting and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the Contact Person listed below in advance of the meeting. The meeting can be accessed from the NIH Videocast at the following link: https://videocast.nih.gov/.
The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Name of Committee: Fogarty International Center Advisory Board.
Date: June 2-3, 2025.
Closed: June 2, 2025, 2:00 p.m. to 5:00 p.m.
Agenda: To review and evaluate to review and evaluate the second level of grant applications.
Address: Fogarty International Center, National Institutes of Health, Lawton Chiles International House (Stone House), 16 Center Drive, Conference Room, Bethesda, MD 20892 (In Person and Virtual Meeting).
Open: June 3, 2025, 9:00 a.m. to 3:00 p.m.
Agenda: Update and discussion of current and planned Fogarty International Center activities.
Address: Fogarty International Center, National Institutes of Health, Lawton Chiles International House (Stone House), 16 Center Drive, Conference Room, Bethesda, MD 20892 (In Person and Virtual Meeting).
Contact Person: Kristen Weymouth, Executive Secretary, Fogarty International Center, 31 Center Drive, Room B2C02, Bethesda, MD 20892, 301-495-1415, kristen.weymouth@nih.gov .
Information is also available on the Institute's/Center's home page: https://www.fic.nih.gov/About/Advisory/Pages/default.aspx, where an agenda and any additional information for the meeting will be posted when available.
In the interest of security, NIH has procedures at https://www.nih.gov/about-nih/visitor-information/campusaccess-security for entrance into on-campus and off-campus facilities. All visitor vehicles, including taxicabs, hotel, and airport shuttles will be inspected before being allowed on campus. Visitors attending a meeting on campus or at an off-campus Federal facility will be asked to show one form of identification (for example, a government-issued photo ID, driver's license, or passport) and to state the purpose of their visit.
(Catalogue of Federal Domestic Assistance Program Nos. 93.106, Minority International Research Training Grant in the Biomedical and Behavioral Sciences; 93.154, Special International Postdoctoral Research Program in Acquired Immunodeficiency Syndrome; 93.168, International Cooperative Biodiversity Groups Program; 93.934, Fogarty International Research Collaboration Award; 93.989, Senior International Fellowship Awards Program, National Institutes of Health, HHS)
Dated: May 6, 2025.
Bruce A. George,

Program Analyst, Office of Federal Advisory Committee Policy.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Pursuant to section 1009 of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meetings.
The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Name of Committee: Molecular, Cellular and Developmental Neuroscience Integrated Review Group; Neurogenesis and Cell Fate Study Section.
Date: June 4-5, 2025.
Time: 9:30 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant applications.
Address: National Institutes of Health, Rockledge II, 6701 Rockledge Drive, Bethesda, MD 20892.
Meeting Format: Virtual Meeting.
Contact Person: Adem Can, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4190, MSC 7850, Bethesda, MD 20892, (301) 435-1042, cana2@csr.nih.gov.
Name of Committee: Center for Scientific Review Special Emphasis Panel; PAR Panel: NINDS Interdisciplinary Team Science RM1 Review (Panel A).
Date: June 5, 2025.
Time: 10:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant applications.
Address: National Institutes of Health, Rockledge II, 6701 Rockledge Drive, Bethesda, MD 20892.
Meeting Format: Virtual Meeting.
Contact Person: Bo-Shiun Chen, Ph.D., Scientific Review Officer, Scientific Review Branch, Division of Extramural Activities, NINDS/NIH, NSC, 6001 Executive Blvd., Suite 3208, MSC 9529, Bethesda, MD 20892, (301) 496-9223, bo-shiun.chen@nih.gov.
Name of Committee: Emerging Technologies and Training Neurosciences Integrated Review Group; Bioengineering and Tissue Engineering for Neuroscience Study Section.
Date: June 10-11, 2025.
Time: 9:00 a.m. to 7:00 p.m.
Agenda: To review and evaluate grant applications.
Address: National Institutes of Health, Rockledge II, 6701 Rockledge Drive, Bethesda, MD 20892.
Meeting Format: Virtual Meeting.
Contact Person: Tina Tze-Tsang Tang, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Suite 3030, Bethesda, MD 20817, (301) 435-4436, tangt@mail.nih.gov.
Name of Committee: Biobehavioral and Behavioral Processes Integrated Review Group; Addiction Risks and Mechanisms Study Section.
Date: June 10-11, 2025.
Time: 10:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant applications.
Address: National Institutes of Health, Rockledge II, 6701 Rockledge Drive, Bethesda, MD 20892.
Meeting Format: Virtual Meeting.
Contact Person: Kristen Prentice, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3112, MSC 7808, Bethesda, MD 20892, (301) 496-0726, prenticekj@mail.nih.gov.
Name of Committee: Brain Disorders and Clinical Neuroscience Integrated Review Group; Pathophysiology of Eye Disease—2 Study Section.
Date: June 11-12, 2025.
Time: 9:00 a.m. to 7:00 p.m.
Agenda: To review and evaluate grant applications.
Address: National Institutes of Health, Rockledge II, 6701 Rockledge Drive, Bethesda, MD 20892.
Meeting Format: Virtual Meeting.
Contact Person: Barbara Susanne Mallon, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892, (301) 480-8992, mallonb@mail.nih.gov.
Name of Committee: Interdisciplinary Molecular Sciences and Training Integrated Review Group; Cellular and Molecular Technologies Study Section.
Date: June 11-12, 2025.
Time: 9:30 a.m. to 6:30 p.m.
Agenda: To review and evaluate grant applications.
Address: National Institutes of Health, Rockledge II, 6701 Rockledge Drive, Bethesda, MD 20892.
Meeting Format: Virtual Meeting.
Contact Person: Tatiana V. Cohen, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5213, Bethesda, MD 20892, 301-455-2364, tatiana.cohen@nih.gov.
Name of Committee: Biological Chemistry and Macromolecular Biophysics Integrated Review Group; Biochemistry and Biophysics of Membranes Study Section.
Date: June 11-12, 2025.
Time: 9:30 a.m. to 8:00 p.m.
Agenda: To review and evaluate grant applications.
Address: National Institutes of Health, Rockledge II, 6701 Rockledge Drive, Bethesda, MD 20892.
Meeting Format: Virtual Meeting.
Contact Person: Irina V. Nesmelova, Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892, (301) 594-6496, irina.nesmelova@nih.gov.
Name of Committee: Center for Scientific Review Special Emphasis Panel; Research Center in Minority Institutions (RCMI).
Date: June 11-13, 2025.
Time: 10:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant applications.
Address: National Institutes of Health, Rockledge II, 6701 Rockledge Drive, Bethesda, MD 20892.
Meeting Format: Virtual Meeting.
Contact Person: Maryline Laude, Ph.D., Scientific Review Officer, National Institute on Minority Health and Health Disparities, NIH, Gateway Building, 7201 Wisconsin Avenue, Ste. 525, MSC 5465, Bethesda, MD 20892, (301) 451-9536, mlaudesharp@mail.nih.gov.
(Catalogue of Federal Domestic Assistance Program Nos. 93.306, Comparative Medicine; 93.333, Clinical Research, 93.306, 93.333, 93.337, 93.393-93.396, 93.837-93.844, 93.846-93.878, 93.892, 93.893, National Institutes of Health, HHS)
Dated: May 6, 2025.
Sterlyn H. Gibson,

Program Specialist, Office of Federal Advisory Committee Policy.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Amended Notice of Meeting
Notice is hereby given of a change in the meeting of the Center for Scientific Review Special Emphasis Panel; RFA-EB-21-001 Technology Development to Reduce Health Disparities, May 30, 2025, 09:00 a.m. to May 30, 2025, 04:00 p.m., National Institutes of Health, Rockledge II, 6701 Rockledge Drive, Bethesda, MD 20892 which was published in the Federal Register on May 01, 2025, 90 FR 18693, FR Doc No. 2025-07594.
This meeting is being amended due to SRO changed from Dr. Vinod Charles to Dr. Yoon-Young Jang. The meeting is closed to the public.
Dated: May 7, 2025.
Sterlyn H. Gibson,

Program Specialist, Office of Federal Advisory Committee Policy.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Center For Scientific Review; Notice of Closed Meetings
Pursuant to section 1009 of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meetings.
The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Name of Committee: Center for Scientific Review Special Emphasis Panel; PAR 22-025: NIDCD Clinical Research Center Grant.
Date: June 6, 2025.
Time: 11:00 a.m. to 3:00 p.m.
Agenda: To review and evaluate grant applications.
Address: National Institutes of Health, Rockledge II, 6701 Rockledge Drive, Bethesda, MD 20892.
Meeting Format: Virtual Meeting.
Contact Person: Elia E Ortenberg, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3108, Bethesda, MD 20892, 301-827-7189, femiaee@csr.nih.gov .
Name of Committee: Integrative, Functional and Cognitive Neuroscience Integrated Review Group; Behavioral Neuroendocrinology, Neuroimmunology, Rhythms, and Sleep Study Section.
Date: June 9-10, 2025.
Time: 8:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant applications.
Address: National Institutes of Health, Rockledge II, 6701 Rockledge Drive, Bethesda, MD 20892.
Meeting Format: Virtual Meeting.
Contact Person: Simon Peter Peron, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Dr., Room 1009K, Bethesda, MD 20892, (301) 594-6236, peronsp@csr.nih.gov .
Name of Committee: Biological Chemistry and Macromolecular Biophysics Integrated Review Group; Macromolecular Structure and Function A Study Section.
Date: June 10-11, 2025.
Time: 10:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant applications.
Address: National Institutes of Health, Rockledge II, 6701 Rockledge Drive, Bethesda, MD 20892.
Meeting Format: Virtual Meeting.
Contact Person: Ian Frederick Thorpe, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 903K, Bethesda, MD 20892, (301) 480-8662, ian.thorpe@nih.gov .
Name of Committee: Genes, Genomes, and Genetics Integrated Review Group; Therapeutic Approaches to Genetic Diseases Study Section.
Date: June 11-12, 2025.
Time: 9:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant applications.
Address: National Institutes of Health, Rockledge II, 6701 Rockledge Drive, Bethesda, MD 20892.
Meeting Format: Virtual Meeting.
Contact Person: Maddalena Tilli Shiffert, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Dr., Room 710P, Bethesda, MD 20892, (301) 594-4257, shiffertmt@csr.nih.gov .
Name of Committee: Aging and Neurodegeneration Integrated Review Group; Aging Systems and Geriatrics Study Section.
Date: June 11-12, 2025.
Time: 9:00 a.m. to 8:00 p.m.
Agenda: To review and evaluate grant applications.
Address: National Institutes of Health, Rockledge II, 6701 Rockledge Drive Bethesda, MD 20892.
Meeting Format: Virtual Meeting.
Contact Person: Roger Alan Bannister, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 1010-D, Bethesda, MD 20892, (301) 435-1042, bannisterra@csr.nih.gov .
Name of Committee: Population Sciences and Epidemiology Integrated Review Group; Lifestyle and Health Behaviors Study Section.
Date: June 11-12, 2025.
Time: 9:30 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant applications.
Address: National Institutes of Health, Rockledge II, 6701 Rockledge Drive, Bethesda, MD 20892.
Meeting Format: Virtual Meeting.
Contact Person: Jewel L Wright, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892, (301) 827-9038, jewel.wright@nih.gov .
(Catalogue of Federal Domestic Assistance Program Nos. 93.306, Comparative Medicine; 93.333, Clinical Research, 93.306, 93.333, 93.337, 93.393-93.396, 93.837-93.844, 93.846-93.878, 93.892, 93.893, National Institutes of Health, HHS)
Dated: May 5, 2025.
Sterlyn H Gibson,

Program Specialist, Office of Federal Advisory Committee Policy.
DEPARTMENT OF HOMELAND SECURITY
Federal Emergency Management Agency
[Docket ID FEMA-2025-0002; Internal Agency Docket No. FEMA-B-2519]
Proposed Flood Hazard Determinations

AGENCY:
Federal Emergency Management Agency, Department of Homeland Security.

ACTION:
Notice.

SUMMARY:
Comments are requested on proposed flood hazard determinations, which may include additions or modifications of any Base Flood Elevation (BFE), base flood depth, Special Flood Hazard Area (SFHA) boundary or zone designation, or regulatory floodway on the Flood Insurance Rate Maps (FIRMs), and where applicable, in the supporting Flood Insurance Study (FIS) reports for the communities listed in the table below. The purpose of this notice is to seek general information and comment regarding the preliminary FIRM, and where applicable, the FIS report that the Federal Emergency Management Agency (FEMA) has provided to the affected communities. The FIRM and FIS report are the basis of the floodplain management measures that the community is required either to adopt or to show evidence of having in effect in order to qualify or remain qualified for participation in the National Flood Insurance Program (NFIP).

DATES:
Comments are to be submitted on or before August 11, 2025.

ADDRESSES:
The Preliminary FIRM, and where applicable, the FIS report for each community are available for inspection at both the online location https://hazards.fema.gov/femaportal/prelimdownload and the respective Community Map Repository address listed in the tables below. Additionally, the current effective FIRM and FIS report for each community are accessible online through the FEMA Map Service Center at https://msc.fema.gov for comparison.
You may submit comments, identified by Docket No. FEMA-B-2519, to Rick Sacbibit, Chief, Engineering Services Branch, Risk Analysis, Planning & Information Directorate, FEMA, 400 C Street SW, Washington, DC 20472, (202) 646-7659, or (email) patrick.sacbibit@fema.dhs.gov.

FOR FURTHER INFORMATION CONTACT:
Rick Sacbibit, Chief, Engineering Services Branch, Risk Analysis, Planning & Information Directorate, FEMA, 400 C Street SW, Washington, DC 20472, (202) 646-7659, or (email) patrick.sacbibit@fema.dhs.gov; or visit the FEMA Mapping and Insurance eXchange (FMIX) online at https://www.floodmaps.fema.gov/fhm/fmx_main.html.

SUPPLEMENTARY INFORMATION:
FEMA proposes to make flood hazard determinations for each community listed below, in accordance with section 110 of the Flood Disaster Protection Act of 1973, 42 U.S.C. 4104, and 44 CFR 67.4(a).
These proposed flood hazard determinations, together with the floodplain management criteria required by 44 CFR 60.3, are the minimum that are required. They should not be construed to mean that the community must change any existing ordinances that are more stringent in their floodplain management requirements. The community may at any time enact stricter requirements of its own or pursuant to policies established by other Federal, State, or regional entities. These flood hazard determinations are used to meet the floodplain management requirements of the NFIP.
The communities affected by the flood hazard determinations are provided in the tables below. Any request for reconsideration of the revised flood hazard information shown on the Preliminary FIRM and FIS report that satisfies the data requirements outlined in 44 CFR 67.6(b) is considered an appeal. Comments unrelated to the flood hazard determinations also will be considered before the FIRM and FIS report become effective.
Use of a Scientific Resolution Panel (SRP) is available to communities in support of the appeal resolution process. SRPs are independent panels of experts in hydrology, hydraulics, and other pertinent sciences established to review conflicting scientific and technical data and provide recommendations for resolution. Use of the SRP only may be exercised after FEMA and local communities have been engaged in a collaborative consultation process for at least 60 days without a mutually acceptable resolution of an appeal. Additional information regarding the SRP process can be found online at https://www.floodsrp.org/pdfs/srp_overview.pdf.
The watersheds and/or communities affected are listed in the tables below. The Preliminary FIRM, and where applicable, FIS report for each community are available for inspection at both the online location https://hazards.fema.gov/femaportal/prelimdownload and the respective Community Map Repository address listed in the tables. For communities with multiple ongoing Preliminary studies, the studies can be identified by the unique project number and Preliminary FIRM date listed in the tables. Additionally, the current effective FIRM and FIS report for each community are accessible online through the FEMA Map Service Center at https://msc.fema.gov for comparison.
(Catalog of Federal Domestic Assistance No. 97.022, “Flood Insurance.”)
Kristin E. Fontenot,

Assistant Administrator, Risk Analysis, Planning & Information Directorate, Federal Emergency Management Agency, Department of Homeland Security.
Community | Community map repository address
Lee County, Florida and Incorporated Areas
Project: 20-04-0036S Preliminary Date: July 25, 2024
Unincorporated Areas of Lee County | Lee County Community Development and Public Works Center, 1500 Monroe Street, 2nd Floor, Fort Myers, FL 33901.
Village of Estero | Village Hall, 9401 Corkscrew Palms Circle, Suite 101, Estero, FL 33928.
DEPARTMENT OF HOMELAND SECURITY
Federal Emergency Management Agency
[Docket ID FEMA-2025-0002; Internal Agency Docket No. FEMA-B-2520]
Changes in Flood Hazard Determinations

AGENCY:
Federal Emergency Management Agency, Department of Homeland Security.

ACTION:
Notice.

SUMMARY:
This notice lists communities where the addition or modification of Base Flood Elevations (BFEs), base flood depths, Special Flood Hazard Area (SFHA) boundaries or zone designations, or the regulatory floodway (hereinafter referred to as flood hazard determinations), as shown on the Flood Insurance Rate Maps (FIRMs), and where applicable, in the supporting Flood Insurance Study (FIS) reports, prepared by the Federal Emergency Management Agency (FEMA) for each community, is appropriate because of new scientific or technical data. The FIRM, and where applicable, portions of the FIS report, have been revised to reflect these flood hazard determinations through issuance of a Letter of Map Revision (LOMR), in accordance with Federal Regulations. The current effective community number is shown in the table below and must be used for all new policies and renewals.

DATES:
These flood hazard determinations will be finalized on the dates listed in the table below and revise the FIRM panels and FIS report in effect prior to this determination for the listed communities.
From the date of the second publication of notification of these changes in a newspaper of local circulation, any person has 90 days in which to request through the community that the Deputy Associate Administrator for Insurance and Mitigation reconsider the changes. The flood hazard determination information may be changed during the 90-day period.

ADDRESSES:
The affected communities are listed in the table below. Revised flood hazard information for each community is available for inspection at both the online location and the respective community map repository address listed in the table below. Additionally, the current effective FIRM and FIS report for each community are accessible online through the FEMA Map Service Center at https://msc.fema.gov for comparison.
Submit comments and/or appeals to the Chief Executive Officer of the community as listed in the table below.

FOR FURTHER INFORMATION CONTACT:
Rick Sacbibit, Chief, Engineering Services Branch, Risk Analysis, Planning & Information Directorate, FEMA, 400 C Street SW, Washington, DC 20472, (202) 646-7659, or (email) patrick.sacbibit@fema.dhs.gov; or visit the FEMA Mapping and Insurance eXchange (FMIX) online at https://www.floodmaps.fema.gov/fhm/fmx_main.html.

SUPPLEMENTARY INFORMATION:
The specific flood hazard determinations are not described for each community in this notice. However, the online location and local community map repository address where the flood hazard determination information is available for inspection is provided.
Any request for reconsideration of flood hazard determinations must be submitted to the Chief Executive Officer of the community as listed in the table below.
The modifications are made pursuant to section 201 of the Flood Disaster Protection Act of 1973, 42 U.S.C. 4105, and are in accordance with the National Flood Insurance Act of 1968, 42 U.S.C. 4001 et seq., and with 44 CFR part 65.
The FIRM and FIS report are the basis of the floodplain management measures that the community is required either to adopt or to show evidence of having in effect in order to qualify or remain qualified for participation in the National Flood Insurance Program (NFIP).
These flood hazard determinations, together with the floodplain management criteria required by 44 CFR 60.3, are the minimum that are required. They should not be construed to mean that the community must change any existing ordinances that are more stringent in their floodplain management requirements. The community may at any time enact stricter requirements of its own or pursuant to policies established by other Federal, State, or regional entities. The flood hazard determinations are in accordance with 44 CFR 65.4.
The affected communities are listed in the following table. Flood hazard determination information for each community is available for inspection at both the online location and the respective community map repository address listed in the table below. Additionally, the current effective FIRM and FIS report for each community are accessible online through the FEMA Map Service Center at https://msc.fema.gov for comparison.
(Catalog of Federal Domestic Assistance No. 97.022, “Flood Insurance.”)
Kristin E. Fontenot,

Assistant Administrator, Risk Analysis, Planning & Information Directorate, Federal Emergency Management Agency, Department of Homeland Security.
State and county | Location and case No. | Chief executive officer of community | Community map repository | Online location of letter of map revision | Date of modification | Community No.
Alabama:
Tuscaloosa | City of Northport (24-04-5206P). | The Honorable John Hinton, Mayor, City of Northport, 3500 McFarland Boulevard, Northport, AL 35476. | City Hall, 3500 McFarland Boulevard, Northport, AL 35476. | https://msc.fema.gov/portal/advanceSearch. | Jun. 20, 2025 | 010202
Tuscaloosa | City of Tuscaloosa (24-04-5206P). | The Honorable Walt Maddox, Mayor, City of Tuscaloosa, 2201 University Boulevard, Tuscaloosa, AL 35401. | City Hall, 2201 University Boulevard, Tuscaloosa, AL 35401. | https://msc.fema.gov/portal/advanceSearch. | Jun. 20, 2025 | 010203
Tuscaloosa | Unincorporated areas of Tuscaloosa County (24-04-5206P). | Ward “Rob” Robertson, III, Chair, Tuscaloosa County Commission, 714 Greensboro Avenue, Tuscaloosa, AL 35401. | Tuscaloosa County Courthouse, 714 Greensboro Avenue, Room 121, Tuscaloosa, AL 35401. | https://msc.fema.gov/portal/advanceSearch. | Jun. 20, 2025 | 010201
Arizona:
Maricopa | City of Litchfield Park (24-09-0662P). | The Honorable Thomas L. Schoaf, Mayor, City of Litchfield Park, 214 West Wigwam Boulevard, Litchfield Park, AZ 85340. | City Hall, 214 West Wigwam Boulevard, Litchfield Park, AZ 85340. | https://msc.fema.gov/portal/advanceSearch. | Jul. 11, 2025 | 040128
Maricopa | City of Phoenix (24-09-0411P). | The Honorable Kate Gallego, Mayor, City of Phoenix, 200 West Washington Street, Phoenix, AZ 85003. | City Hall, 200 West Washington Street, Phoenix, AZ 85003. | https://msc.fema.gov/portal/advanceSearch. | Jun. 20, 2025 | 040051
Pima | Town of Oro Valley (23-09-0234P). | The Honorable Joe Winfield, Mayor, Town of Oro Valley, 11000 North La Canada Drive, Oro Valley, AZ 85737. | Planning and Zoning Department, 11000 North La Canada Drive, Oro Valley, AZ 85737. | https://msc.fema.gov/portal/advanceSearch. | Jul. 11, 2025 | 040109
California:
Orange | City of Irvine (24-09-0442P). | The Honorable Larry Agran, Mayor, City of Irvine, 1 Civic Center Plaza, Irvine, CA 92606. | Development Engineering Department, 1 Civic Center Plaza, Irvine, CA 92606. | https://msc.fema.gov/portal/advanceSearch. | Jul. 15, 2025 | 060222
Riverside | Agua Caliente Band of Cahuilla Indians Tribe (24-09-0978P). | Reid D. Milanovich, Chair, Tribal Council of the Agua Caliente Band of Cahuilla Indians, 5401 Dinah Shore Drive, Palm Springs, CA 92264. | Agua Caliente Band of Cahuilla Indians, 5401 Dinah Shore Drive, Palm Springs, CA 92264. | https://msc.fema.gov/portal/advanceSearch. | Jul. 18, 2025 | 060763
| Riverside | City of Cathedral City (24-09-0978P). | The Honorable Mark Carnevale, Mayor, City of Cathedral City, 68-700 Avenida Lalo Guerrero, Cathedral City, CA 92234. | City Hall, 68-700 Avenida Lalo Guerrero, Cathedral City, CA 92234. | https://msc.fema.gov/portal/advanceSearch. | Jul. 18, 2025 | 060704
Riverside | City of Norco (25-09-0007P). | The Honorable Greg Newton, Mayor, City of Norco, 2870 Clark Avenue, Norco, CA 92860. | City Hall, 2870 Clark Avenue, Norco, CA 92860. | https://msc.fema.gov/portal/advanceSearch. | Jul. 18, 2025 | 060256
Riverside | City of Palm Springs (24-09-0978P). | Scott Stiles, Manager, City of Palm Springs, 3200 East Tahquitz Canyon Way, Palm Springs, CA 92262. | City Hall, 3200 East Tahquitz Canyon Way, Palm Springs, CA 92262. | https://msc.fema.gov/portal/advanceSearch. | Jul. 18, 2025 | 060257
San Diego | City of San Marcos (24-09-1116P). | The Honorable Rebecca Jones, Mayor, City of San Marcos, 1 Civic Center Drive, San Marcos, CA 92069. | City Hall, 1 Civic Center Drive, San Marcos, CA 92069. | https://msc.fema.gov/portal/advanceSearch. | Jul. 7, 2025 | 060296
San Luis Obispo | City of El Paso de Robles (25-09-0412P). | The Honorable John Hamon, Mayor, City of El Paso de Robles, 1000 Spring Street, Paso Robles, CA 93446. | City Hall, 1000 Spring Street, Paso Robles, CA 93446. | https://msc.fema.gov/portal/advanceSearch. | Jul. 17, 2025 | 060308
Colorado:
Boulder | Unincorporated areas of Boulder County (24-08-0327P) | Marta Loachamin, Chair, Boulder County Board of Commissioners, 1325 Pearl Street, Boulder, CO 80302. | Boulder County Transportation Department, 2525 13th Street, Suite 203, Boulder, CO 80304. | https://msc.fema.gov/portal/advanceSearch. | Jun. 30, 2025 | 080023
Jefferson | City of Arvada (24-08-0434P). | The Honorable Lauren Simpson, Mayor, City of Arvada, 8101 Ralston Road, Arvada, CO 80002. | Engineering Department, 8101 Ralston Road, Arvada, CO 80002. | https://msc.fema.gov/portal/advanceSearch. | Jul. 18, 2025 | 085072
Jefferson | Unincorporated areas of Jefferson County (24-08-0434P). | Lesley Dahlkemper, Chair, Jefferson County, Board of Commissioners, 100 Jefferson County Parkway, Suite 5550, Golden, CO 80419. | Jefferson County, Planning and Zoning Division, 100 Jefferson County Parkway, Suite 3550, Golden, CO 80419. | https://msc.fema.gov/portal/advanceSearch. | Jul. 18, 2025 | 080087
Florida:
Baker | Unincorporated areas of Baker County (24-04-6923P). | Jimmy Anderson, Chair, Baker County Board of Commissioners, 55 North 3rd Street, MacClenny, FL 32063. | Baker County Community Development Department, 360 East Shuey Avenue, MacClenny, FL 32063. | https://msc.fema.gov/portal/advanceSearch. | Jul. 18, 2025 | 120419
Bay | City of Panama City (24-04-5173P). | The Honorable Michael Rohan Sr., Mayor, City of Panama City, 501 Harrison Avenue, Panama City, FL 32401. | Public Works Department, Engineering Division, 501 Harrison Avenue, Panama City, FL 32401. | https://msc.fema.gov/portal/advanceSearch. | Jul. 17, 2025 | 120012
Clay. | Unincorporated areas of Clay County (24-04-2893P). | The Honorable Betsy Condon, Chair, Clay County Board of Commissioners, P.O. Box 1366, Green Cove Springs, FL 32043. | Clay County Administration Building, 477 Houston Street, Green Cove Springs, FL 32043. | https://msc.fema.gov/portal/advanceSearch. | Aug. 1, 2025 | 120064
Hillsborough | City of Tampa (24-04-6556P). | The Honorable Jane Castor, Mayor, City of Tampa, 306 East Jackson Street, Tampa, FL 33602. | City Hall, 306 East Jackson Street, Tampa, FL 33602. | https://msc.fema.gov/portal/advanceSearch. | Jul. 21, 2025 | 120114
Manatee | City of Bradenton (24-04-4585P). | The Honorable Gene Brown, Mayor, City of Bradenton, 101 Old Main Street, Bradenton, FL 34205. | Building Department, 101 Old Main Street, Bradenton, FL 34205. | https://msc.fema.gov/portal/advanceSearch. | Jun. 9, 2025 | 120155
Manatee | Unincorporated areas of Manatee County (23-04-6199P). | Charlie Bishop, Manatee County Administrator, 1112 Manatee Avenue West, Bradenton, FL 34205. | Manatee County Administration Building, 1112 Manatee Avenue West, Bradenton, FL 34205. | https://msc.fema.gov/portal/advanceSearch. | Jun. 19, 2025 | 120153
Orange | City of Orlando (24-04-6249P). | The Honorable Buddy Dyer, Mayor, City of Orlando, 400 South Orange Avenue, Orlando, FL 32801. | Public Works Department, Engineering Division, 400 South Orange Avenue, 8th Floor, Orlando, FL 32801. | https://msc.fema.gov/portal/advanceSearch. | Jul. 25, 2025 | 120186
| Pasco | Unincorporated areas of Pasco County (24-04-3863P). | Kathryn Starkey, Chair, Pasco County Board of Commissioners, 37918 Meridian Avenue, Dade City, FL 33525. | Pasco County Building Construction Services Department, 8661 Citizens Drive, Suite 100, New Port Richey, FL 34654. | https://msc.fema.gov/portal/advanceSearch. | Aug. 4, 2025 | 120230
Seminole | City of Lake Mary (24-04-2032P). | Kevin Smith, Manager, City of Lake Mary, 100 North Country Club Road, Lake Mary, FL 32746. | Department of Public Works, 911 Wallace Court, Lake Mary, FL 32746. | https://msc.fema.gov/portal/advanceSearch. | Jun. 12, 2025 | 120416
Georgia: Columbia | Unincorporated areas of Columbia County (24-04-1033P). | Douglas R. Duncan, Jr., Chair, Columbia County Board of Commissioners, 630 Ronald Reagan Drive, Building B, Evans, GA 30809. | Columbia County Engineering Services Division, Stormwater Compliance Department, 630 Ronald Reagan Drive, Building A, Evans, GA 30809. | https://msc.fema.gov/portal/advanceSearch. | Jul. 25, 2025 | 130059
Indiana:
Hamilton. | City of Noblesville (24-05-1632P). | The Honorable Chris Jensen, Mayor, City of Noblesville, 16 South 10th Street, Noblesville, IN 46060. | City Hall, 16 South 10th Street, Noblesville, IN 46060. | https://msc.fema.gov/portal/advanceSearch. | Jul. 22, 2025 | 180082
Hamilton | Unincorporated areas of Hamilton County (24-05-1632P). | Mark Heirbrandt, President, Hamilton County Board of Commissioners, 1 Hamilton County Square, Suite 157, Noblesville, IN 46060. | Hamilton County Administration Building, 1 Hamilton County Square, Suite 13, Noblesville, IN 46060. | https://msc.fema.gov/portal/advanceSearch. | Jul. 22, 2025 | 180080
Morgan | Town of Mooresville (24-05-1099P). | Tom Warthen, President, Town of Mooresville Council, 4 East Harrison Street, Mooresville, IN 46158. | Public Works Department, 4 East Harrison Street, Mooresville, IN 46158. | https://msc.fema.gov/portal/advanceSearch. | Jul. 18, 2025 | 180334
Morgan | Unincorporated areas of Morgan County (24-05-1099P). | The Honorable Don Adams, President, Morgan County Board of Commissioners, 180 South Main Street, Suite 112, Martinsville, IN 46151. | Morgan County Administration Building, 180 South Main Street, Martinsville, IN 46151. | https://msc.fema.gov/portal/advanceSearch. | Jul. 18, 2025 | 180176
Minnesota: Hennepin | City of Maple Grove (24-05-2167P). | Heidi Nelson, Administrator, City of Maple Grove, 12800 Arbor Lakes Parkway North, Maple Grove, MN 55369. | City Hall, 12800 Arbor Lakes Parkway North, Maple Grove, MN 55369. | https://msc.fema.gov/portal/advanceSearch. | Jul. 18, 2025 | 270169
Nevada:
Washoe | City of Sparks (24-09-0898P). | The Honorable Ed Lawson, Mayor, City of Sparks, 431 Prater Way, Sparks, NV 89431. | City Hall, 431 Prater Way, Sparks, NV 89431. | https://msc.fema.gov/portal/advanceSearch. | Jul. 11, 2025 | 320021
Washoe | Unincorporated areas of Washoe County (24-09-0898P). | Eric Brown, Washoe County Manager, 1001 East 9th Street, Reno, NV 89512. | Washoe County Administration Complex, 1001 East 9th Street, Reno, NV 89512. | https://msc.fema.gov/portal/advanceSearch. | Jul. 11, 2025 | 320019
Washoe | Unincorporated areas of Washoe County (24-09-0938P). | Eric Brown, Washoe County Manager, 1001 East 9th Street, Reno, NV 89512. | Washoe County Administration Complex, 1001 East 9th Steet, Reno, NV 89512. | https://msc.fema.gov/portal/advanceSearch. | Jul. 7, 2025 | 320019
North Dakota: Cass | City of Horace (24-08-0240P). | The Honorable Jeff Trudeau, Mayor, City of Horace, P.O. Box 99, Horace, ND 58047. | City Hall, 215 Park Drive East, Horace, ND 58047. | https://msc.fema.gov/portal/advanceSearch. | Jul. 15, 2025 | 380022
Ohio: Lucas | Unincorporated areas of Lucas County (24-05-0756P). | Lisa A. Sobecki, President, Lucas County Board of Commissioners, 1 Government Center, Toledo, OH 43604. | Lucas County Government Center, 1 Government Center, Toledo, OH 43604. | https://msc.fema.gov/portal/advanceSearch. | Jul. 25, 2025 | 390359
Oklahoma: Canadian | City of Oklahoma City (24-06-2550P). | The Honorable David Holt, Mayor, City of Oklahoma City, 200 North Walker Avenue, 3rd Floor, Oklahoma City, OK 73102. | Public Works Department, 420 West Main Street, Suite 700, Oklahoma City, OK 73102. | https://msc.fema.gov/portal/advanceSearch. | Jul. 21, 2025 | 405378
Texas:
| Collin | City of McKinney (24-06-1188P). | The Honorable George Fuller, Mayor, City of McKinney, 401 East Virginia Street, McKinney, TX 75069. | Public Works Department, 3501 North Central Parkway, McKinney, TX 75071. | https://msc.fema.gov/portal/advanceSearch. | Aug. 4, 2025 | 480135
Collin | City of Lavon (24-06-2255P). | The Honorable Vicki Sanson, Mayor, City of Lavon, 120 School Road, Lavon, TX 75166. | City Hall, 120 School Road, Lavon, TX 75166. | https://msc.fema.gov/portal/advanceSearch. | Jun. 9, 2025 | 481313
Collin | Unincorporated areas of Collin County (24-06-2255P). | The Honorable Chris Hill, Collin County Judge, 2300 Bloomdale Road, 1st Floor, McKinney, TX 75071. | Collin County Engineering and Building Department, 4690 Community Avenue, Suite 200, McKinney, TX 75071. | https://msc.fema.gov/portal/advanceSearch. | Jun. 9, 2025 | 480130
Denton | City of Celina (24-06-1095P). | The Honorable Ryan Tubbs, Mayor, City of Celina, 142 North Ohio Street, Celina, TX 75009. | City Hall, 142 North Ohio Street, Celina, TX 75009. | https://msc.fema.gov/portal/advanceSearch. | Jul. 21, 2025 | 480133
Denton | Unincorporated areas of Denton County (24-06-1095P). | The Honorable Andy Eads, Denton County Judge, 1 Courthouse Drive, Denton, TX 76208. | Denton County Development Services Department, 3900 Morse Street, Denton, TX 76208. | https://msc.fema.gov/portal/advanceSearch. | Jul. 21, 2025 | 480774
Johnson | City of Cleburne (24-06-1581P). | The Honorable Scott Cain, Mayor, City of Cleburne, P.O. Box 677, Cleburne, TX 76033. | City Hall, 10 North Robinson Street, Cleburne, TX 76031. | https://msc.fema.gov/portal/advanceSearch. | Jul. 11, 2025 | 485462
DEPARTMENT OF THE INTERIOR
Bureau of Indian Affairs
[256A2100DD/AAKP300000/A0A501010.000000; OMB Control Number 1076-0020]
Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Loan Guarantee, Insurance, and Interest Subsidy Program

AGENCY:
Bureau of Indian Affairs, Interior.

ACTION:
Notice of Information Collection; request for comment.

SUMMARY:
In accordance with the Paperwork Reduction Act of 1995, we, the Office of the Assistant Secretary—Indian Affairs (OAS-IA), are proposing to renew an information collection.

DATES:
Interested persons are invited to submit comments. To be considered, your comments must be received on or before June 11, 2025.

ADDRESSES:
Send your written comments and recommendations for the proposed information collection request (ICR) to the Office of Information and Regulatory Affairs (OIRA) through https://www.reginfo.gov/public/do/PRA/icrPublicCommentRequest?ref_nbr=202405-1076-017 or by visiting https://www.reginfo.gov/public/do/PRAMain and selecting “Currently under Review—Open for Public Comments” and then scrolling down to the “Department of the Interior.”

FOR FURTHER INFORMATION CONTACT:
Steven Mullen, Information Collection Clearance Officer, Office of Regulatory Affairs and Collaborative Action—Indian Affairs, U.S. Department of the Interior, 1001 Indian School Road NW, Suite 229, Albuquerque, New Mexico 87104; comments@bia.gov; (202) 924-2650. Individuals in the United States who are deaf, deafblind, hard of hearing, or have a speech disability may dial 711 (TTY, TDD, or TeleBraille) to access telecommunications relay services. You may also view the ICR at https://www.reginfo.gov/public/Forward?SearchTarget=PRA&textfield=1076-0020.

SUPPLEMENTARY INFORMATION:
In accordance with the Paperwork Reduction Act of 1995 (PRA, 44 U.S.C. 3501 et seq. ) and 5 CFR 1320.8(d)(1), we provide the general public and other Federal agencies with an opportunity to comment on new, proposed, revised, and continuing collections of information. This helps us assess the impact of our information collection requirements and minimize the public's reporting burden. It also helps the public understand our information collection requirements and provide the requested data in the desired format.
A Federal Register notice with a 60-day public comment period soliciting comments on this collection of information was published on June 21, 2024 (89 FR 52076). No comments were received.
As part of our continuing effort to reduce paperwork and respondent burdens, we are again soliciting comments from the public and other Federal agencies on the proposed ICR that is described below. We are especially interested in public comment addressing the following:
(1) Whether or not the collection of information is necessary for the proper performance of the functions of the agency, including whether or not the information will have practical utility;
(2) The accuracy of our estimate of the burden for this collection of information, including the validity of the methodology and assumptions used;
(3) Ways to enhance the quality, utility, and clarity of the information to be collected; and
(4) How might the agency minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of response.
Comments that you submit in response to this notice are a matter of public record. Before including your address, phone number, email address, or other personal identifying information in your comment, you should be aware that your entire comment—including your personal identifying information—may be made publicly available at any time. While you can ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so.
Abstract: The Office of Indian Economic Development (OIED) will use the information collected to implement the Loan Guarantee, Insurance, and Interest Subsidy Program, 25 U.S.C. 1451 et seq. The purpose of the collection is to encourage private lending to individual Indians and Indian organizations by providing lenders with loan guarantees or loan insurance to reduce their potential financial risk. The information collection allows OIED to determine the eligibility and credit-worthiness of respondents and loans; and otherwise ensure compliance with Program requirements. This information collection includes the use of several forms.
Title of Collection: Loan Guarantee, Insurance, and Interest Subsidy Program, 25 CFR part 103.
OMB Control Number: 1076-0020.
Form Number: ALD10, CFL10, ISR10, LGA10, LGC10, LIA10, NIL10, NOD10, RGI10.
Type of Review: Extension of a currently approved collection.
Respondents/Affected Public: Lenders, including commercial banks, and borrowers, including individual Indians and Indian organizations.
Total Estimated Number of Annual Respondents: 622.
Total Estimated Number of Annual Responses: 1,377.
Estimated Completion Time per Response: Ranging from 0.5 to 2 hours.
Total Estimated Number of Annual Burden Hours: 2,654 hours.
Respondent's Obligation: Required to obtain or retain a benefit.
Frequency of Collection: On occasion.
Total Estimated Annual Nonhour Burden Cost: $0.

Authority
An agency may not conduct or sponsor and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number. The authority for this action is the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ).
Scott J. Davis,

Senior Advisor to the Secretary of the Interior, Exercising the delegated authority of the Assistant Secretary—Indian Affairs.
DEPARTMENT OF THE INTERIOR
Bureau of Indian Affairs
[256A2100DD/AAKP300000/A0A501010.000000; OMB Control Number 1076-0112]
Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Tribal Reassumption of Jurisdiction Over Child Custody Proceedings

AGENCY:
Bureau of Indian Affairs, Interior.

ACTION:
Notice of Information Collection; request for comment.

SUMMARY:
In accordance with the Paperwork Reduction Act of 1995, we, the Bureau of Indian Affairs (BIA), are proposing to renew an information collection.

DATES:
Interested persons are invited to submit comments. To be considered, your comments must be received on or before June 11, 2025.

ADDRESSES:
Submit your written comments and recommendations for the proposed information collection request (ICR) to the Office of Information and Regulatory Affairs (OIRA) through https://www.reginfo.gov/public/do/PRA/icrPublicCommentRequest?ref_nbr=202405-1076-019 or by visiting https://www.reginfo.gov/public/do/PRAMain and selecting “Currently under Review—Open for Public Comments” and then scrolling down to the “Department of the Interior.”

FOR FURTHER INFORMATION CONTACT:
Steven Mullen, Information Collection Clearance Officer, Office of Regulatory Affairs and Collaborative Action—Indian Affairs, U.S. Department of the Interior, 1001 Indian School Road NW, Suite 229, Albuquerque, New Mexico 87104; comments@bia.gov; (202) 924-2650. Individuals in the United States who are deaf, deafblind, hard of hearing, or have a speech disability may dial 711 (TTY, TDD, or TeleBraille) to access telecommunications relay services. You may also view the ICR at https://www.reginfo.gov/public/Forward?SearchTarget=PRA&textfield=1076-0112.

SUPPLEMENTARY INFORMATION:
In accordance with the Paperwork Reduction Act of 1995 (PRA, 44 U.S.C. 3501 et seq. ) and 5 CFR 1320.8(d)(1), we provide the general public and other Federal agencies with an opportunity to comment on new, proposed, revised, and continuing collections of information. This helps us assess the impact of our information collection requirements and minimize the public's reporting burden. It also helps the public understand our information collection requirements and provide the requested data in the desired format.
A Federal Register notice with a 60-day public comment period soliciting comments on this collection of information was published on June 21, 2024 (89 FR 52076). No comments were received.
As part of our continuing effort to reduce paperwork and respondent burdens, we are again soliciting comments from the public and other Federal agencies on the proposed ICR that is described below. We are especially interested in public comment addressing the following:
(1) Whether or not the collection of information is necessary for the proper performance of the functions of the agency, including whether or not the information will have practical utility;
(2) The accuracy of our estimate of the burden for this collection of information, including the validity of the methodology and assumptions used;
(3) Ways to enhance the quality, utility, and clarity of the information to be collected; and
(4) How might the agency minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of response.
Comments that you submit in response to this notice are a matter of public record. Before including your address, phone number, email address, or other personal identifying information in your comment, you should be aware that your entire comment—including your personal identifying information—may be made publicly available at any time. While you can ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so.
Abstract: The BIA is seeking to renew the information collection conducted under 25 CFR part 13, “Tribal Reassumption of Jurisdiction over Child Custody Proceedings.” Part 13 prescribes procedures by which a federally recognized Tribe that occupies Tribal lands over which a State asserts any jurisdiction pursuant to Federal law may reassume jurisdiction over Indian child proceedings as authorized by the Indian Child Welfare Act (25 U.S.C. 1918). Any federally recognized Tribe that became subject to State jurisdiction pursuant to the provisions of the Act of August 15, 1953 (18 U.S.C. 1162), or pursuant to any other Federal law, may reassume jurisdiction over child custody proceedings.
The collection of information provides data that will be used in considering the petition and feasibility of the plan of the Tribe for reassumption of jurisdiction over Indian child custody proceedings. We collect the following information: Full name, address, and telephone number of petitioning Tribe or Tribes; a Tribal resolution; estimated total number of members in the petitioning Tribe or Tribes with an explanation of how the number was estimated; current criteria for Tribal membership; citation to provision in Tribal constitution authorizing the Tribal governing body to exercise jurisdiction over Indian child custody matters; description of Tribal court; copy of any Tribal ordinances or Tribal court rules establishing procedures or rules for exercise of jurisdiction over child custody matters; and all other information required by 25 CFR 13.11.
Title of Collection: Tribal Reassumption of Jurisdiction over Child Custody Proceedings, 25 CFR part 13.
OMB Control Number: 1076-0112.
Form Number: None.
Type of Review: Extension of a currently approved collection.
Respondents/Affected Public: Federally recognized Tribes who submit Tribal reassumption petitions for review and approval by the Secretary of the Interior.
Total Estimated Number of Annual Respondents: 1.
Total Estimated Number of Annual Responses: 1.
Estimated Completion Time per Response: 8 hours.
Total Estimated Number of Annual Burden Hours: 8 hours.
Respondent's Obligation: Required to obtain or retain a benefit.
Frequency of Collection: On occasion.
Total Estimated Annual Nonhour Burden Cost: None.

Authority
An agency may not conduct or sponsor and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number. The authority for this action is the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ).
Scott J. Davis,

Senior Advisor to the Secretary of the Interior, Exercising the delegated authority of the Assistant Secretary—Indian Affairs.
DEPARTMENT OF THE INTERIOR
Bureau of Indian Affairs
[256A2100DD/AAKP300000/A0A501010.000000; OMB Control Number 1076-0184]
Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Bureau of Indian Affairs Housing Improvement Program

AGENCY:
Bureau of Indian Affairs, Interior.

ACTION:
Notice of Information Collection; request for comment.

SUMMARY:
In accordance with the Paperwork Reduction Act of 1995, we, the Bureau of Indian Affairs (BIA) are proposing to renew an information collection.

DATES:
Interested persons are invited to submit comments. To be considered, your comments must be received on or before June 11, 2025.

ADDRESSES:
Written comments and recommendations for the proposed information collection request (ICR) should be sent to the Office of Information and Regulatory Affairs (OIRA) through https://www.reginfo.gov/public/do/PRA/icrPublicCommentRequest?ref_nbr=202405-1076-022 or by visiting https://www.reginfo.gov/public/do/PRAMain and selecting “Currently under Review—Open for Public Comments” and then scrolling down to the “Department of the Interior.”

FOR FURTHER INFORMATION CONTACT:
Steven Mullen, Information Collection Clearance Officer, Office of Regulatory Affairs and Collaborative Action—Indian Affairs, U.S. Department of the Interior, 1001 Indian School Road NW, Suite 229, Albuquerque, New Mexico 87104; comments@bia.gov; (202) 924-2650. Individuals in the United States who are deaf, deafblind, hard of hearing, or have a speech disability may dial 711 (TTY, TDD, or TeleBraille) to access telecommunications relay services. You may also view the ICR at https://www.reginfo.gov/public/Forward?SearchTarget=PRA&textfield=1076-0184.

SUPPLEMENTARY INFORMATION:
In accordance with the Paperwork Reduction Act of 1995 (PRA, 44 U.S.C. 3501 et seq. ) and 5 CFR 1320.8(d)(1), we provide the general public and other Federal agencies with an opportunity to comment on new, proposed, revised, and continuing collections of information. This helps us assess the impact of our information collection requirements and minimize the public's reporting burden. It also helps the public understand our information collection requirements and provide the requested data in the desired format.
A Federal Register notice with a 60-day public comment period soliciting comments on this collection of information was published on June 21, 2024 (89 FR 52076). No comments were received.
As part of our continuing effort to reduce paperwork and respondent burdens, we are again soliciting comments from the public and other Federal agencies on the proposed ICR that is described below. We are especially interested in public comment addressing the following:
(1) Whether or not the collection of information is necessary for the proper performance of the functions of the agency, including whether or not the information will have practical utility;
(2) The accuracy of our estimate of the burden for this collection of information, including the validity of the methodology and assumptions used;
(3) Ways to enhance the quality, utility, and clarity of the information to be collected; and
(4) How might the agency minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of response.
Comments that you submit in response to this notice are a matter of public record. Before including your address, phone number, email address, or other personal identifying information in your comment, you should be aware that your entire comment—including your personal identifying information—may be made publicly available at any time. While you can ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so.
Abstract: The regulations governing the Housing Improvement Program, 25 CFR part 256, provide Tribes with flexibility to address members requesting housing assistance. The BIA will use the information collected to determine applicant eligibility for housing services based upon the criteria referenced in 25 CFR 256.9 (repairs and renovation assistance) and 256.10 (replacement housing assistance). Enrolled members of a federally recognized Tribe, who live within a Tribe's designated and approved service area, submit information on an application form.
Title of Collection: Bureau of Indian Affairs Housing Improvement Program (HIP).
OMB Control Number: 1076-0184.
Form Number: BIA-6407, Tribal Annual Performance Report (TAPR) Excel workbook, and the Government Performance Results Act (GPRA) Reporting Form.
Type of Review: Extension of a currently approved collection.
Respondents/Affected Public: Individuals.
Total Estimated Number of Annual Respondents: 12,292 per year, on average.
Total Estimated Number of Annual Responses: 12,523 per year, on average.
Estimated Completion Time per Response: Varies between 15 and 30 minutes.
Total Estimated Number of Annual Burden Hours: 5,185 hours.
Respondent's Obligation: Required to obtain a benefit.
Frequency of Collection: Once per year for the HIP application, HIP addendum, and TAPR workbook. Quarterly for the GPRA reporting form.
Total Estimated Annual Nonhour Burden Cost: $0.

Authority
An agency may not conduct or sponsor and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number. The authority for this action is the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ).
Scott J. Davis,

Senior Advisor to the Secretary,

Exercising the delegated authority of the Assistant Secretary—Indian Affairs.
DEPARTMENT OF JUSTICE
Antitrust Division
United States of America v. XCL Resources Holdings, LLC, Verdun Oil Company II, LLC, and EP Energy LLC
Notice is hereby given pursuant to the Antitrust Procedures and Penalties Act, 15 U.S.C. 16(b)-(h), that the Response of Plaintiff United States to Public Comment on the Proposed Final Judgment in United States of America v. XCL Resources Holdings, LLC, Verdun Oil Company II, LLC, and EP Energy LLC, Civil Action No. 1:25-cv-00041 has been filed in the United States District Court for the District of Columbia, together with the response of the United States to the comment.
Copies of the public comment and the United States' Response are available for inspection on the Antitrust Division's website at http://www.justice.gov/atr.
Suzanne Morris,

Deputy Director of Civil Enforcement Operations.

United States District Court for the District of Columbia
United States of America, Plaintiff, v. XCL Resources Holdings, LLC,
Verdun Oil Company II LLC, and EP Energy LLC, Defendants.
Civil Action No. 1:25-cv-00041-TSC

Response of Plaintiff United States to Public Comment on the Proposed Final Judgment
Pursuant to the requirements of the Antitrust Procedures and Penalties Act (the “APPA” or “Tunney Act”), 15 U.S.C. 16, the United States hereby responds to the one public comment received regarding the proposed Final Judgment in this case. After careful consideration of the submitted comment, the United States continues to believe that the civil penalties and injunctive relief required by the proposed Final Judgment provides an effective and appropriate remedy for the violation alleged in the Complaint and is therefore in the public interest. The United States will move the Court for entry of the proposed Final Judgment after the public comment and this response have been published as required by 15 U.S.C. 16(d).

I. Procedural History
On July 26, 2021, Defendants Verdun Oil Company II LLC (“Verdun”) and EP Energy LLC (“EP”) entered into a Membership Interest Purchase Agreement (“Purchase Agreement”) whereby Verdun proposed to acquire EP for approximately $1.4 billion. The proposed transaction was subject to notification and waiting-period requirements imposed by Section 7A of the Clayton Act, 15 U.S.C. 18a, commonly known as the Hart-Scott-Rodino Antitrust Improvements Act of 1976 (the “HSR Act”). Defendants made the required pre-merger notification filing with the antitrust agencies; they failed, however, to satisfy their waiting-period obligations. Instead, upon executing the Purchase Agreement, EP allowed Verdun and its sister company, Defendant XCL Resources Holdings, LLC (“XCL”), to assume operational and decision-making control over significant aspects of EP's day-to-day business operations.
The United States filed a civil antitrust Complaint against Defendants on January 7, 2025, seeking civil penalties and equitable relief for the violation of the HSR Act. The Complaint alleges that Defendants were in continuous violation of the HSR Act from July 26, 2021, through October 27, 2021, when Defendants amended the Purchase Agreement and Verdun and XCL ceased exercising operational control over EP's business. See Dkt. No. 1-1.
At the same time the Complaint was filed, the United States filed a proposed Final Judgment and a Stipulation and Order in which the United States and Defendants consent to entry of the proposed Final Judgment after compliance with the requirements of the Tunney Act, 15 U.S.C. 16. See Dkt. Nos. 1-2, 1-3. The proposed Final Judgment requires Defendants to pay civil penalties totaling of $5,684,377 within 30 days of entry of the Final Judgment, prohibits Defendants from engaging in specified conduct designed to prevent future violations of the HSR Act, and imposes compliance and compliance-reporting obligations.
Pursuant to the APPA's requirements, the United States filed a Competitive Impact Statement (“CIS”) on January 7, 2025, describing the transaction and the proposed Final Judgment. See Dkt. No. 1-4. On January 21, 2025, the United States published the Complaint, proposed Final Judgment, and CIS in the Federal Register , see 90 FR 7159, and caused notice regarding the same, together with directions for the submission of written comments relating to the proposed Final Judgment, to be published in The Washington Post for seven days, from January 15, 2025 through January 21, 2025. The 60-day period for public comment ended on March 24, 2025. The United States received one comment, attached as Exhibit A.

II. The Complaint and the Proposed Final Judgment
The Complaint alleges that Defendants were in continuous violation of the HSR Act each day beginning on July 26, 2021, and ending on October 27, 2021, when XCL and Verdun ceased exercising operational control over relevant aspects of EP's business.
The HSR Act's reporting and waiting-period requirements apply to a transaction if, as a result of the transaction, the acquirer will “hold” assets or voting securities valued above the applicable thresholds. Under HSR Rule 801.1(c), to “hold” assets or voting securities means “beneficial ownership, whether direct, or indirect through fiduciaries, agents, controlled entities or other means.” 16 CFR 801.1(c). Thus, under the HSR Act, parties must make an HSR Act filing and observe a waiting period before transferring beneficial ownership of the assets or voting securities to be acquired. The Statement of Basis and Purpose accompanying the Rules explains that beneficial ownership is determined on a case-by-case basis, based on the indicia of beneficial ownership which include, among others, the right to obtain the benefit of any increase in value or dividends and the risk of loss of value. 43 FR 33449 (July 31, 1978). A firm may also gain beneficial ownership by obtaining “operational control” of an asset.
The rights provided by EP to XCL and Verdun in the Purchase Agreement, and XCL and Verdun's exercise of those rights in the period following signing the Purchase Agreement, transferred beneficial ownership of EP's business to XCL and Verdun before Defendants had fulfilled their obligations under the HSR Act. Specifically, the Purchase Agreement provided for the immediate transfer of control over key aspects of EP's business to XCL and Verdun, including granting XCL and Verdun approval rights over EP's ongoing and planned crude oil development and production activities and many of EP's ordinary-course expenditures. XCL put an immediate halt to EP's new well-drilling activities, so that XCL could control the development and production plans for EP's drilling assets moving forward. Even though XCL and Verdun eventually allowed EP to resume its own well-drilling and planning activities, the temporary halts resulted in EP having crude oil supply shortages in the following months. Defendants predicted these shortages would occur, and the Purchase Agreement specifically provided that XCL and Verdun—not EP—would bear all costs associated with EP's supply shortages.
XCL and Verdun also exercised operational control over EP by, inter alia, working directly with EP's customers on EP's behalf; requiring EP to provide competitively sensitive information to XCL and Verdun businesspeople; requiring approval of ordinary-course expenditures; and coordinating with EP on EP's contract negotiations with certain customers in the Eagle Ford production area. The illegal conduct lasted through October 27, 2021, when the Defendants executed an amendment to the Purchase Agreement which allowed EP to once again operate independently and in the ordinary course of business, without XCL's or Verdun's control over its day-to-day operations.
The Defendants were in violation of the HSR Act for a period of 94 days, from when the Purchase Agreement was signed on July 26, 2021 until the Purchase Agreement was amended on October 27, 2021.
As explained in the CIS, the proposed Final Judgment will prevent future violations of the HSR Act of the type Defendants committed and secures monetary civil penalties. The proposed Final Judgment sets forth prohibited and permitted conduct, requires Defendants to maintain compliance programs, and provides procedures to ensure ongoing compliance. These conditions will expire ten years after the entry of the Final Judgment. The proposed Final Judgment also imposes civil penalties in the amount of $5,684,377. The penalty amount was adjusted downward from the maximum permitted under the HSR Act, in part because Defendants were willing to resolve the matter by consent decree and avoid a prolonged investigation and litigation.

III. Standard of Judicial Review
Under the Clayton Act and APPA, proposed Final Judgments, or “consent decrees,” in antitrust cases brought by the United States are subject to a 60-day comment period, after which the court shall determine whether entry of the proposed Final Judgment is “in the public interest.” 15 U.S.C. 16(e)(1). In making that determination, the court, in accordance with the statute as amended in 2004, is required to consider:
(A) the competitive impact of such judgment, including termination of alleged violations, provisions for enforcement and modification, duration of relief sought, anticipated effects of alternative remedies actually considered, whether its terms are ambiguous, and any other competitive considerations bearing upon the adequacy of such judgment that the court deems necessary to a determination of whether the consent judgment is in the public interest; and
(B) the impact of entry of such judgment upon competition in the relevant market or markets, upon the public generally and individuals alleging specific injury from the violations set forth in the complaint including consideration of the public benefit, if any, to be derived from a determination of the issues at trial.
Id. § 16(e)(1)(A) & (B). In considering these statutory factors, the court's inquiry is necessarily a limited one, as the government is entitled to “broad discretion to settle with the defendant within the reaches of the public interest.” United States v. Microsoft Corp., 56 F.3d 1448, 1461 (D.C. Cir. 1995); United States v. U.S. Airways Group, Inc., 38 F. Supp. 3d 69, 75 (D.D.C. 2014) (noting the government has broad discretion of the adequacy of the relief at issue); United States v. InBev N.V./S.A., No. 08-1965 (JR), 2009-2 Trade Cas. (CCH) ¶ 76,736, 2009 U.S. Dist. LEXIS 84787, at *3, (D.D.C. Aug. 11, 2009) (noting that the court's review of a consent judgment is limited and only inquires “into whether the government's determination that the proposed remedies will cure the antitrust violations alleged in the complaint was reasonable, and whether the mechanism to enforce the final judgment are clear and manageable”).
As the United States Court of Appeals for the District of Columbia Circuit has held the APPA requires the court to consider, among other things, the relationship between the specific allegations in the government's Complaint and the remedy secured, whether the proposed Final Judgment is sufficiently clear, whether its enforcement mechanisms are sufficient, and whether it may positively harm third parties. See Microsoft, 56 F.3d at 1458-62. With respect to the adequacy of the relief secured by the proposed Final Judgment, a court may not “make de novo determination of facts and issues.” United States v. W. Elec. Co., 993 F.2d 1572, 1577 (D.C. Cir. 1993) (quotation marks omitted); see also Microsoft, 56 F.3d at 1460-62; United States v. Alcoa, Inc., 152 F. Supp. 2d 37, 40 (D.D.C. 2001); United States v. Enova Corp., 107 F. Supp. 2d 10, 16 (D.D.C. 2000); InBev, 2009 U.S. Dist. LEXIS 84787, at *3.
Instead, “[t]he balancing of competing social and political interests affected by a proposed antitrust decree must be left, in the first instance, to the discretion of the Attorney General.” W. Elec. Co., 993 F.2d at 1577 (quotation marks omitted). “The court should also bear in mind the flexibility of the public interest inquiry: the court's function is not to determine whether the resulting array of rights and liabilities is the one that will best serve society, but only to confirm that the resulting settlement is within the reaches of the public interest.” Microsoft, 56 F.3d at 1460 (quotation marks omitted); see also United States v. Deutsche Telekom AG, No. 19-2232 (TJK), 2020 WL 1873555, at *7 (D.D.C. Apr. 14, 2020). More demanding requirements would “have enormous practical consequences for the government's ability to negotiate future settlements,” contrary to congressional intent. Microsoft, 56 F.3d at 1456. “The Tunney Act was not intended to create a disincentive to the use of the consent decree.” Id.
The United States' predictions about the efficacy of the remedy are to be afforded deference by the Court. See, e.g., Microsoft, 56 F.3d at 1461 (recognizing courts should give “due respect to the Justice Department's . . . view of the nature of its case”); United States v. Iron Mountain, Inc., 217 F. Supp. 3d 146, 152-53 (D.D.C. 2016) (“In evaluating objections to settlement agreements under the Tunney Act, a court must be mindful that [t]he government need not prove that the settlements will perfectly remedy the alleged antitrust harms[;] it need only provide a factual basis for concluding that the settlements are reasonably adequate remedies for the alleged harms.” (internal citations omitted)); United States v. Republic Servs., Inc., 723 F. Supp. 2d 157, 160 (D.D.C. 2010) (noting “the deferential review to which the government's proposed remedy is accorded”); United States v. Archer-Daniels-Midland Co., 272 F. Supp. 2d 1, 6 (D.D.C. 2003) (“A district court must accord due respect to the government's prediction as to the effect of proposed remedies, its perception of the market structure, and its view of the nature of the case.”). The ultimate question is whether “the remedies [obtained by the Final Judgment are] so inconsonant with the allegations charged as to fall outside of the `reaches of the public interest.' ” Microsoft, 56 F.3d at 1461 ( quoting W. Elec. Co., 900 F.2d at 309).
Moreover, the court's role under the APPA is limited to reviewing the remedy in relationship to the violations that the United States has alleged in its Complaint and does not authorize the court to “construct [its] own hypothetical case and then evaluate the decree against that case.” Microsoft, 56 F.3d at 1459; see also U.S. Airways, 38 F. Supp. 3d at 75 (noting that the court must simply determine whether there is a factual foundation for the government's decisions such that its conclusions regarding the proposed settlements are reasonable); InBev, 2009 U.S. Dist. LEXIS 84787, at *20 (concluding that “the `public interest' is not to be measured by comparing the violations alleged in the complaint against those the court believes could have, or even should have, been alleged”). Because the “court's authority to review the decree depends entirely on the government's exercising its prosecutorial discretion by bringing a case in the first place,” it follows that “the court is only authorized to review the decree itself,” and not to “effectively redraft the complaint” to inquire into other matters that the United States did not pursue. Microsoft, 56 F.3d at 1459-60. As this Court confirmed in SBC Communications, courts “cannot look beyond the complaint in making the public interest determination unless the complaint is drafted so narrowly as to make a mockery of judicial power.” 489 F. Supp. 2d at 15.
In its 2004 amendments to the APPA, Congress made clear its intent to preserve the practical benefits of using judgments proposed by the United States in antitrust enforcement, adding the unambiguous instruction that “[n]othing in this section shall be construed to require the court to conduct an evidentiary hearing or to require the court to permit anyone to intervene.” 15 U.S.C. 16(e)(2); see also U.S. Airways, 38 F. Supp. 3d at 76 (indicating that a court is not required to hold an evidentiary hearing or to permit intervenors as part of its review under the Tunney Act). This language explicitly wrote into the statute what Congress intended when it enacted the Tunney Act in 1974. As Senator Tunney explained: “The court is nowhere compelled to go to trial or to engage in extended proceedings which might have the effect of vitiating the benefits of prompt and less costly settlement through the consent decree process.” 119 Cong. Rec. 24,598 (1973) (statement of Sen. Tunney). “A court can make its public interest determination based on the competitive impact statement and response to public comments alone.” U.S. Airways, 38 F. Supp. 3d at 76 (citing Enova Corp., 107 F. Supp. 2d at 17).

IV. Summary of the Comment and the United States' Response
The United States received one public comment in response to the proposed Final Judgment from a member of the public. The commenter inquires as to (a) whether the Defendant companies were publicly traded and, if so, whether the conduct alleged in the Complaint affected the pricing of stock transactions, and (b) whether civil penalties would address harm, if any, to consumers potentially paying more at the gas pump.
Nothing in the comment warrants a change to the proposed Final Judgment or supports a conclusion that the proposed Final Judgment is not in the public interest. Section (g)(1) of the HSR Act, 15 U.S.C. 18a(g)(1), provides that the United States may recover a civil penalty for violations of the HSR Act. Here, Defendants will pay civil penalties totaling $5,694,377 pursuant to the terms of the proposed Final Judgment, representing approximately 65 percent of the statutory maximum. ^1 The United States has determined that this amount, along with the additional injunctive relief, will appropriately penalize Defendants and deter it and others from future violations of the HSR Act. As required by the APPA, the comment ^2 and this response will be published in the Federal Register .
^1 The maximum daily civil penalty, which had been $10,000, was increased to $11,000 for violations occurring on or after November 20, 1996, pursuant to the Debt Collection Improvement Act of 1996, Public Law 104-134 § 31001(s) and FTC Rule 1.98, 16 D.C.F.R. 1.98, 61 FR 54548 (Oct. 21, 1996). The maximum daily penalty is adjusted annually in accordance with the Federal Civil Penalties Inflation Adjustment Act Improvement Act of 2015, and is currently $53,088 for violations occurring on or after January 17, 2025. See, 90 Fed Reg. 5580 (Jan. 17, 2025). The maximum daily penalty in effect at the time of Defendant's conduct was $46,517 per day.
^2 Aside from a redaction of personally identifiable information, the comment is provided in its entirety.

V. Conclusion
After careful consideration of the public comment, the United States continues to believe that the proposed Final Judgment provides an effective and appropriate remedy for the violation alleged in the Complaint and is therefore in the public interest. The United States will move this Court to enter the Final Judgment after the comment and this response are published as required by 15 U.S.C. 16(d).
Dated: May 6, 2025.
Respectfully Submitted,
For Plaintiff United States of America

/s/ Kenneth A. Libby
Kenneth A. Libby,
Special Attorney for the United States, c/o Federal Trade Commission, 600 Pennsylvania Avenue NW, Washington, DC 20580, Tel: (202) 326-2694, Email: klibby@ftc.gov .

Exhibit A
Miercoles 08 Emero 2025
Dear Ms. Petrizzi,
Following news release on justice.gov website. I'm submitting my comments or questions about Tunney Act enforcement in USA vrs. XCL, Verdun, EP energy.
1. DOJ is asking on penalties for HSR Act. The companies are publicly traded? Iff, then where there public transactions on price for stock affected by their concert in pricing. How is that being litigated?
2. The price of by products, i.e. gas at the pump would have being affected by those actions? That would mean civil penalties for those affected?
I thank you for allowing to learn from your pursuit of the rule of law. That premise of equality, freedom, and justice is what makes the United States and its constitution a most beatiful country. Something admirable and worth protecting.
Praying for your continued success.
Saludos cordiales,
[Redacted]
DEPARTMENT OF JUSTICE
Parole Commission
Sunshine Act Meeting

DATE AND TIME:
Thursday, May 15, at 1 p.m.

PLACE:
U.S. Parole Commission, 90 K Street NE, 3rd Floor, Washington, DC.

STATUS:
Open.

MATTERS TO BE CONSIDERED:
1. Approval of November 14, 2024, Meeting Minutes.
2. Verbal Updates since the November Meeting from the Acting Chairman, Commissioner, Acting Chief of Staff, Acting Case Operations Administrator, Case Services Administrator, and General Counsel.

CONTACT PERSON FOR MORE INFORMATION:
Jacquelyn Graham, Staff Assistant to the Chairman, U.S. Parole Commission, 90 K Street NE, 3rd Floor, Washington, DC 20530, (202) 346-7010.
Dated: May 8, 2025.
Patricia K. Cushwa,

Chairman (Acting), U.S. Parole Commission.
LEGAL SERVICES CORPORATION
Sunshine Act Meetings

FEDERAL REGISTER CITATION OF PREVIOUS ANNOUNCEMENT:
90 FR 14392.

PREVIOUSLY ANNOUNCED TIME AND DATE OF THE MEETING:
April 7, 2025.

CHANGES IN THE MEETING:
In the Federal Register notice published on Tuesday, April 1, the Legal Services Corporation announced the April 7, 2025, meeting of the Finance Committee of LSC's Board of Directors. The meeting was announced as fully open to public observation. However, at the beginning of that meeting, the Committee determined it needed to close a portion of the meeting. On a motion of Committee Member Fr. Pius Pietrzyk, seconded by Committee Member John G. Levi (Chairman, LSC Board of Directors), and approved by the unanimous vote of Committee Members present (Fr. Pius Pietrzyk, John G. Levi, Committee Chair Robert J. Grey, Jr., Robert E. Henley, Jr. (Non-Director Member), Rebecca Rapp (Non-Director Member), Paul Snyder (Non-Director Member), and Allan Tanenbaum (Non-Director Member)), the Committee voted to close a portion of the meeting to consider matters related to the Corporation's internal activities and a request to consider and act on a resolution to recommend revising the Corporation's line of credit agreement. No earlier announcement of the change was possible. The meeting closure was authorized under 45 CFR 1622.5(a) and (g).

CONTACT PERSON FOR MORE INFORMATION:
Jessica Wechter, Special Assistant to the President, at (202) 295-1626. Questions may also be sent by electronic mail to wechterj@lsc.gov.
Dated: May 7, 2025.
Stefanie Davis,

Deputy General Counsel, Legal Services Corporation.
NUCLEAR REGULATORY COMMISSION
[Docket No. 040-38417; NRC-2025-0084]
Disa Technologies, Inc; License Application

AGENCY:
Nuclear Regulatory Commission.

ACTION:
Opportunity to request a hearing and to petition for leave to intervene; order imposing procedures.

SUMMARY:
The U.S. Nuclear Regulatory Commission (NRC) has received a license application from Disa Technologies, Inc (Disa) for a multi-site service provider license for its high-pressure slurry ablation (HPSA) technology to remediate abandoned uranium mine (AUM) waste. Disa's request (Docket #040-38417) is to use HPSA technology to perform remediation at certain AUM sites after additional site-specific safety and environmental information is provided to and approved by the NRC. Because the license application contains Sensitive Unclassified Non-Safeguards Information (SUNSI), an order imposes procedures to obtain access to SUNSI for contention preparation by persons who file a hearing request or petitions for leave to intervene.

DATES:
A request for a hearing or petition for leave to intervene must be filed by July 11, 2025. Any potential party as defined in section 2.4 of title 10 of the Code of Federal Regulations (10 CFR) who believes access is necessary to respond to this notice must request document access by May 22, 2025.

ADDRESSES:
Please refer to Docket ID NRC-2025-0084 when contacting the NRC about the availability of information for this action. You may obtain publicly available information related to this action by any of the following methods:
• Federal Rulemaking Website: Go to https://www.regulations.gov and search for Docket ID NRC-2025-0084. Address questions about Docket IDs in Regulations.gov to Bridget Curran; telephone: 301-415-1003; email: Bridget.Curran@nrc.gov. For technical questions, contact the individual listed in the For Further Information Contact section of this document.
• NRC's Agencywide Documents Access and Management System (ADAMS): You may obtain publicly available documents online in the ADAMS Public Documents collection at https://www.nrc.gov/reading-rm/adams.html. To begin the search, select “Begin Web-based ADAMS Search.” For problems with ADAMS, please contact the NRC's Public Document Room (PDR) reference staff at 1-800-397-4209, at 301-415-4737, or by email to PDR.Resource@nrc.gov. The ADAMS accession number for each document referenced (if it is available in ADAMS) is provided the first time that it is mentioned in this document.
• NRC's PDR: The PDR, where you may examine and order copies of publicly available documents, is open by appointment. To make an appointment to visit the PDR, please send an email to PDR.Resource@nrc.gov or call 1-800-397-4209 or 301-415-4737, between 8 a.m. and 4 p.m. eastern time (ET), Monday through Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT:
Priya Yadav, Office of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; telephone: 301-415-6667; email: Priya.Yadav@nrc.gov.

I. Introduction
On March 28, 2025, Disa submitted an application to the NRC for a multi-site service provider license for its HPSA technology to remediate AUM waste (ADAMS Package Accession No. ML25087A094). The application was submitted after staff conducted a pre-submittal audit (ADAMS Package Accession No. ML25036A182). The application is entitled “Application for a Performance-Based, Multi-Site Radioactive Materials License to Operate a High-Pressure Slurry Ablation Remediation System, Revision 3 Casper, Wyoming.”
An NRC administrative completeness review found the application acceptable for a technical review (ADAMS Accession No. ML25099A303). Prior to making a licensing decision on the application, the NRC will need to make the findings required by the Atomic Energy Act of 1954, as amended (the Act), and the NRC's regulations. The NRC's findings will be documented in a safety evaluation report and an environmental assessment (EA). The NRC will publish the EA and corresponding draft finding of no significant impact, provided a determination of no significant impacts is reached, in a future Federal Register notice for public review and comment. As appropriate and in accordance with 10 CFR 51.33, the NRC will consider comments received on the draft EA in preparing a final EA, provided a determination of no significant impacts is reached.
This license, if approved, would allow Disa to use HPSA technology to perform AUM waste remediation at AUM sites, after additional site-specific safety and environmental information is provided to and approved by the NRC. The application NRC received does not indicate any specific sites or locations where Disa plans to use HPSA technology. Disa states in the application that the specific sites will be provided to NRC through pre-mobilization notifications, if NRC grants the license.

II. Opportunity To Request a Hearing and Petition for Leave To Intervene
Within 60 days after the date of publication of this notice, any persons (petitioner) whose interest may be affected by this action may file a request for a hearing and petition for leave to intervene (petition) with respect to the action. Petitions shall be filed in accordance with the Commission's “Agency Rules of Practice and Procedure” in 10 CFR part 2. Interested persons should consult a current copy of 10 CFR 2.309. If a petition is filed, the presiding officer will rule on the petition and, if appropriate, a notice of a hearing will be issued.
Petitions must be filed no later than 60 days from the date of publication of this notice in accordance with the filing instructions in the “Electronic Submissions (E-Filing)” section of this document. Petitions and motions for leave to file new or amended contentions that are filed after the deadline will not be entertained absent a determination by the presiding officer that the filing demonstrates good cause by satisfying the three factors in 10 CFR 2.309(c)(1)(i) through (iii).
A State, local governmental body, Federally recognized Indian Tribe, or designated agency thereof, may submit a petition to the Commission to participate as a party under 10 CFR 2.309(h) no later than 60 days from the date of publication of this notice. Alternatively, a State, local governmental body, Federally recognized Indian Tribe, or agency thereof may participate as a non-party under 10 CFR 2.315(c).
For information about filing a petition and about participation by a person not a party under 10 CFR 2.315, see ADAMS Accession No. ML20340A053 ( https://adamswebsearch2.nrc.gov/webSearch2/main.jsp?AccessionNumber=ML20340A053 ) and on the NRC's public website at https://www.nrc.gov/about-nrc/regulatory/adjudicatory/hearing.html#participate.

III. Electronic Submissions (E-Filing)
All documents filed in NRC adjudicatory proceedings, including documents filed by an interested State, local governmental body, Federally recognized Indian Tribe, or designated agency thereof that requests to participate under 10 CFR 2.315(c), must be filed in accordance with 10 CFR 2.302. The E-Filing process requires participants to submit and serve all adjudicatory documents over the internet, or in some cases, to mail copies on electronic storage media, unless an exemption permitting an alternative filing method, as further discussed, is granted. Detailed guidance on electronic submissions is located in the “Guidance for Electronic Submissions to the NRC” (ADAMS Accession No. ML13031A056) and on the NRC's public website at https://www.nrc.gov/site-help/e-submittals.html.
To comply with the procedural requirements of E-Filing, at least 10 days prior to the filing deadline, the participant should contact the Office of the Secretary by email at Hearing.Docket@nrc.gov, or by telephone at 301-415-1677, to (1) request a digital identification (ID) certificate, which allows the participant (or its counsel or representative) to digitally sign submissions and access the E-Filing system for any proceeding in which it is participating; and (2) advise the Secretary that the participant will be submitting a petition or other adjudicatory document (even in instances in which the participant, or its counsel or representative, already holds an NRC-issued digital ID certificate). Based upon this information, the Secretary will establish an electronic docket for the proceeding if the Secretary has not already established an electronic docket.
Information about applying for a digital ID certificate is available on the NRC's public website at https://www.nrc.gov/site-help/e-submittals/getting-started.html. After a digital ID certificate is obtained and a docket created, the participant must submit adjudicatory documents in Portable Document Format. Guidance on submissions is available on the NRC's public website at https://www.nrc.gov/site-help/electronic-sub-ref-mat.html. A filing is considered complete at the time the document is submitted through the NRC's E-Filing system. To be timely, an electronic filing must be submitted to the E-Filing system no later than 11:59 p.m. ET on the due date. Upon receipt of a transmission, the E-Filing system time-stamps the document and sends the submitter an email confirming receipt of the document. The E-Filing system also distributes an email that provides access to the document to the NRC's Office of the General Counsel and any others who have advised the Office of the Secretary that they wish to participate in the proceeding, so that the filer need not serve the document on those participants separately. Therefore, applicants and other participants (or their counsel or representative) must apply for and receive a digital ID certificate before adjudicatory documents are filed to obtain access to the documents via the E-Filing system.
A person filing electronically using the NRC's adjudicatory E-Filing system may seek assistance by contacting the NRC's Electronic Filing Help Desk through the “Contact Us” link located on the NRC's public website at https://www.nrc.gov/site-help/e-submittals.html, by email to MSHD.Resource@nrc.gov, or by a toll-free call at 1-866-672-7640. The NRC Electronic Filing Help Desk is available between 9 a.m. and 6 p.m., ET, Monday through Friday, except Federal holidays.
Participants who believe that they have good cause for not submitting documents electronically must file an exemption request, in accordance with 10 CFR 2.302(g), with their initial paper filing stating why there is good cause for not filing electronically and requesting authorization to continue to submit documents in paper format. Such filings must be submitted in accordance with 10 CFR 2.302(b)-(d). Participants filing adjudicatory documents in this manner are responsible for serving their documents on all other participants. Participants granted an exemption under 10 CFR 2.302(g)(2) must still meet the electronic formatting requirement in 10 CFR 2.302(g)(1), unless the participant also seeks and is granted an exemption from 10 CFR 2.302(g)(1).
Documents submitted in adjudicatory proceedings will appear in the NRC's electronic hearing docket, which is publicly available at https://adams.nrc.gov/ehd, unless excluded pursuant to an order of the presiding officer. If you do not have an NRC-issued digital ID certificate as previously described, click “cancel” when the link requests certificates and you will be automatically directed to the NRC's electronic hearing docket where you will be able to access any publicly available documents in a particular hearing docket. Participants are requested not to include personal privacy information such as social security numbers, home addresses, or personal phone numbers in their filings unless an NRC regulation or other law requires submission of such information. With respect to copyrighted works, except for limited excerpts that serve the purpose of the adjudicatory filings and would constitute a Fair Use application, participants should not include copyrighted materials in their submission.

Order Imposing Procedures for Access to Sensitive Unclassified Non-Safeguards Information for Contention Preparation

Disa Technologies, Inc
A. This Order contains instructions regarding how potential parties to this proceeding may request access to documents containing Sensitive Unclassified Non-Safeguards Information (SUNSI).
B. Within 10 days after publication of this notice of hearing or opportunity for hearing, any potential party who believes access to SUNSI is necessary to respond to this notice may request access to SUNSI. A “potential party” is any person who intends to participate as a party by demonstrating standing and filing an admissible contention under 10 CFR 2.309. Requests for access to SUNSI submitted later than 10 days after publication of this notice will not be considered absent a showing of good cause for the late filing, addressing why the request could not have been filed earlier.
C. The requestor shall submit a letter requesting permission to access SUNSI to the Office of the Secretary, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, Attention: Rulemakings and Adjudications Staff, and provide a copy to the Deputy General Counsel for Licensing, Hearings, and Enforcement, Office of the General Counsel, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001. The expedited delivery or courier mailing address for both offices is: U.S. Nuclear Regulatory Commission, 11555 Rockville Pike, Rockville, Maryland 20852. The email addresses for the Office of the Secretary and the Office of the General Counsel are Hearing.Docket@nrc.gov and RidsOgcMailCenter.Resource@nrc.gov, respectively. ^1 The request must include the following information:
^1 While a request for hearing or petition to intervene in this proceeding must comply with the filing requirements of the NRC's “E-Filing Rule,” the initial request to access SUNSI under these procedures should be submitted as described in this paragraph.
(1) A description of the licensing action with a citation to this Federal Register notice;
(2) The name and address of the potential party and a description of the potential party's particularized interest that could be harmed by the action identified in C.(1); and
(3) The identity of the individual or entity requesting access to SUNSI and the requestor's basis for the need for the information in order to meaningfully participate in this adjudicatory proceeding. In particular, the request must explain why publicly available versions of the information requested would not be sufficient to provide the basis and specificity for a proffered contention.
D. Based on an evaluation of the information submitted under paragraph C, the NRC staff will determine within 10 days of receipt of the request whether:
(1) There is a reasonable basis to believe the requestor is likely to establish standing to participate in this NRC proceeding; and
(2) The requestor has established a legitimate need for access to SUNSI.
E. If the NRC staff determines that the requestor satisfies both D.(1) and D.(2), the NRC staff will notify the requestor in writing that access to SUNSI has been granted. The written notification will contain instructions on how the requestor may obtain copies of the requested documents, and any other conditions that may apply to access to those documents. These conditions may include, but are not limited to, the signing of a draft Non-Disclosure Agreement or Affidavit, or Protective Order ^2 setting forth terms and conditions to prevent the unauthorized or inadvertent disclosure of SUNSI by each individual who will be granted access to SUNSI.
^2 Any motion for Protective Order or draft Non-Disclosure Agreement or Affidavit for SUNSI must be filed with the presiding officer or the Chief Administrative Judge if the presiding officer has not yet been designated, within 30 days of the deadline for the receipt of the written access request.
F. Filing of Contentions. Any contentions in these proceedings that are based upon the information received as a result of the request made for SUNSI must be filed by the requestor no later than 25 days after receipt of (or access to) that information. However, if more than 25 days remain between the requestor's receipt of (or access to) the information and the deadline for filing all other contentions (as established in the notice of hearing or opportunity for hearing), the requestor may file its SUNSI contentions by that later deadline.
G. Review of Denials of Access.
(1) If the request for access to SUNSI is denied by the NRC staff after a determination on standing and requisite need, the NRC staff shall immediately notify the requestor in writing, briefly stating the reason or reasons for the denial.
(2) The requestor may challenge the NRC staff's adverse determination by filing a challenge within 5 days of receipt of that determination with: (a) the presiding officer designated in this proceeding; or (b) if no presiding officer has been appointed, the Chief Administrative Judge, or if this individual is unavailable, another administrative judge, or an Administrative Law Judge with jurisdiction pursuant to 10 CFR 2.318(a); or (c) if another officer has been designated to rule on information access issues, then with that officer.
(3) Further appeals of decisions under this paragraph must be made pursuant to 10 CFR 2.311.
H. Review of Grants of Access. A party other than the requestor may challenge an NRC staff determination granting access to SUNSI whose release would harm that party's interest independent of the proceeding. Such a challenge must be filed within 5 days of the notification by the NRC staff of its grant of access and must be filed with: (a) the presiding officer designated in this proceeding; or (b) if no presiding officer has been appointed, the Chief Administrative Judge, or if this individual is unavailable, another administrative judge, or an Administrative Law Judge with jurisdiction pursuant to 10 CFR 2.318(a); or (c) if another officer has been designated to rule on information access issues, then with that officer.
If challenges to the NRC staff determinations are filed, these procedures give way to the normal process for litigating disputes concerning access to information. Interlocutory review by the Commission on orders ruling on such NRC staff determinations (whether granting or denying access) is governed by 10 CFR 2.311. ^3
^3 Requestors should note that the filing requirements of the NRC's E-Filing Rule (72 FR 49139; August 28, 2007, as amended at 77 FR 46562; August 3, 2012, 78 FR 34247, June 7, 2013) apply to appeals of NRC staff determinations (because they must be served on a presiding officer or the Commission, as applicable), but not to the initial SUNSI request submitted to the NRC staff under these procedures.
I. The Commission expects that the NRC staff and presiding officers (and any other reviewing officers) will consider and resolve requests for access to SUNSI, and motions for protective orders, in a timely fashion in order to minimize any unnecessary delays in identifying those petitioners who have standing and who have propounded contentions meeting the specificity and basis requirements in 10 CFR part 2. The attachment to this Order summarizes the general target schedule for processing and resolving requests under these procedures.
It is so ordered.
Dated: May 7, 2025.
For the Nuclear Regulatory Commission.
Carrie Safford,

Secretary of the Commission.

Attachment 1—General Target Schedule for Processing and Resolving Requests for Access to Sensitive Unclassified Non-Safeguards Information in This Proceeding
Day | Event/activity
0 | Publication of Federal Register notice of hearing or opportunity for hearing, including order with instructions for access requests.
10 | Deadline for submitting requests for access to Sensitive Unclassified Non-Safeguards Information (SUNSI) with information: (i) supporting the standing of a potential party identified by name and address; and (ii) describing the need for the information in order for the potential party to participate meaningfully in an adjudicatory proceeding.
60 | Deadline for submitting petition for intervention containing: (i) demonstration of standing; and (ii) all contentions whose formulation does not require access to SUNSI (+25 Answers to petition for intervention; +7 petitioner/requestor reply).
20 | U.S. Nuclear Regulatory Commission (NRC) staff informs the requestor of the staff's determination whether the request for access provides a reasonable basis to believe standing can be established and shows need for SUNSI. (NRC staff also informs any party to the proceeding whose interest independent of the proceeding would be harmed by the release of the information.) If NRC staff makes the finding of need for SUNSI and likelihood of standing, NRC staff begins document processing (preparation of redactions or review of redacted documents).
25 | If NRC staff finds no “need” or no likelihood of standing, the deadline for petitioner/requestor to file a motion seeking a ruling to reverse the NRC staff's denial of access; NRC staff files copy of access determination with the presiding officer (or Chief Administrative Judge or other designated officer, as appropriate). If NRC staff finds “need” for SUNSI, the deadline for any party to the proceeding whose interest independent of the proceeding would be harmed by the release of the information to file a motion seeking a ruling to reverse the NRC staff's grant of access.
30 | Deadline for NRC staff reply to motions to reverse NRC staff determination(s).
40 | (Receipt +30) If NRC staff finds standing and need for SUNSI, deadline for NRC staff to complete information processing and file motion for Protective Order and draft Non-Disclosure Agreement or Affidavit. Deadline for applicant/licensee to file Non-Disclosure Agreement or Affidavit for SUNSI.
A | If access granted: issuance of presiding officer or other designated officer decision on motion for protective order for access to sensitive information (including schedule for providing access and submission of contentions) or decision reversing a final adverse determination by the NRC staff.
A + 3 | Deadline for filing executed Non-Disclosure Agreements or Affidavits. Access provided to SUNSI consistent with decision issuing the protective order.
A + 28 | Deadline for submission of contentions whose development depends upon access to SUNSI. However, if more than 25 days remain between the petitioner's receipt of (or access to) the information and the deadline for filing all other contentions (as established in the notice of hearing or notice of opportunity for hearing), the petitioner may file its SUNSI contentions by that later deadline.
A + 53 | (Contention receipt +25) Answers to contentions whose development depends upon access to SUNSI.
A + 60 | (Answer receipt +7) Petitioner/Intervenor reply to answers.
>A + 60 | Decision on contention admission.
POSTAL REGULATORY COMMISSION
[Docket Nos. MC2025-1356 and K2025-1356; MC2025-1357 and K2025-1357; MC2025-1358 and K2025-1358; MC2025-1359 and K2025-1359; MC2025-1360 and K2025-1360; MC2025-1361 and K2025-1361; MC2025-1362 and K2025-1362]
New Postal Products

AGENCY:
Postal Regulatory Commission.

ACTION:
Notice.

SUMMARY:
The Commission is noticing a recent Postal Service filing for the Commission's consideration concerning a negotiated service agreement. This notice informs the public of the filing, invites public comment, and takes other administrative steps.

DATES:
Comments are due: May 14, 2025.

ADDRESSES:
Submit comments electronically via the Commission's Filing Online system at https://www.prc.gov. Those who cannot submit comments electronically should contact the person identified in the FOR FURTHER INFORMATION CONTACT section by telephone for advice on filing alternatives.

FOR FURTHER INFORMATION CONTACT:
David A. Trissell, General Counsel, at 202-789-6820.

SUPPLEMENTARY INFORMATION:

Table of Contents
I. Introduction
II. Public Proceeding(s)
III. Summary Proceeding(s)

I. Introduction
Pursuant to 39 CFR 3041.405, the Commission gives notice that the Postal Service filed request(s) for the Commission to consider matters related to Competitive negotiated service agreement(s). The request(s) may propose the addition of a negotiated service agreement from the Competitive product list or the modification of an existing product currently appearing on the Competitive product list.
The public portions of the Postal Service's request(s) can be accessed via the Commission's website ( http://www.prc.gov ). Non-public portions of the Postal Service's request(s), if any, can be accessed through compliance with the requirements of 39 CFR 3011.301. ^1
^1 See Docket No. RM2018-3, Order Adopting Final Rules Relating to Non-Public Information, June 27, 2018, Attachment A at 19-22 (Order No. 4679).
Section II identifies the docket number(s) associated with each Postal Service request, if any, that will be reviewed in a public proceeding as defined by 39 CFR 3010.101(p), the title of each such request, the request's acceptance date, and the authority cited by the Postal Service for each request. For each such request, the Commission appoints an officer of the Commission to represent the interests of the general public in the proceeding, pursuant to 39 U.S.C. 505 and 39 CFR 3000.114 (Public Representative). The Public Representative does not represent any individual person, entity or particular point of view, and, when Commission attorneys are appointed, no attorney-client relationship is established. Section II also establishes comment deadline(s) pertaining to each such request.
The Commission invites comments on whether the Postal Service's request(s) identified in Section II, if any, are consistent with the policies of title 39. Applicable statutory and regulatory requirements include 39 U.S.C. 3632, 39 U.S.C. 3633, 39 U.S.C. 3642, 39 CFR part 3035, and 39 CFR part 3041. Comment deadline(s) for each such request, if any, appear in Section II.
Section III identifies the docket number(s) associated with each Postal Service request, if any, to add a standardized distinct product to the Competitive product list or to amend a standardized distinct product, the title of each such request, the request's acceptance date, and the authority cited by the Postal Service for each request. Standardized distinct products are negotiated service agreements that are variations of one or more Competitive products, and for which financial models, minimum rates, and classification criteria have undergone advance Commission review. See 39 CFR 3041.110(n); 39 CFR 3041.205(a). Such requests are reviewed in summary proceedings pursuant to 39 CFR 3041.325(c)(2) and 39 CFR 3041.505(f)(1). Pursuant to 39 CFR 3041.405(c)-(d), the Commission does not appoint a Public Representative or request public comment in proceedings to review such requests.

II. Public Proceeding(s)
1. Docket No(s).: MC2025-1356 and K2025-1356; Filing Title: USPS Request to Add Priority Mail & USPS Ground Advantage Contract 731 to the Competitive Product List and Notice of Filing Materials Under Seal; Filing Acceptance Date: May 6, 2025; Filing Authority: 39 U.S.C. 3642, 39 CFR 3035.105, and 39 CFR 3041.310; Public Representative: Jennaca Upperman; Comments Due: May 14, 2025.
2. Docket No(s).: MC2025-1357 and K2025-1357; Filing Title: USPS Request to Add Priority Mail Express, Priority Mail & USPS Ground Advantage Contract 1364 to the Competitive Product List and Notice of Filing Materials Under Seal; Filing Acceptance Date: May 6, 2025; Filing Authority: 39 U.S.C. 3642, 39 CFR 3035.105, and 39 CFR 3041.310; Public Representative: Jennaca Upperman; Comments Due: May 14, 2025.
3. Docket No(s).: MC2025-1358 and K2025-1358; Filing Title: USPS Request to Add Priority Mail & USPS Ground Advantage Contract 732 to the Competitive Product List and Notice of Filing Materials Under Seal; Filing Acceptance Date: May 6, 2025; Filing Authority: 39 U.S.C. 3642, 39 CFR 3035.105, and 39 CFR 3041.310; Public Representative: Maxine Bradley; Comments Due: May 14, 2025.
4. Docket No(s).: MC2025-1359 and K2025-1359; Filing Title: USPS Request to Add Priority Mail Contract 804 to the Competitive Product List and Notice of Filing Materials Under Seal; Filing Acceptance Date: May 6, 2025; Filing Authority: 39 U.S.C. 3642, 39 CFR 3035.105, and 39 CFR 3041.310; Public Representative: Arif Hafiz; Comments Due: May 14, 2025.
5. Docket No(s).: MC2025-1360 and K2025-1360; Filing Title: USPS Request to Add Priority Mail Contract 805 to the Competitive Product List and Notice of Filing Materials Under Seal; Filing Acceptance Date: May 6, 2025; Filing Authority: 39 U.S.C. 3642, 39 CFR 3035.105, and 39 CFR 3041.310; Public Representative: Almaroof Agoro; Comments Due: May 14, 2025.
6. Docket No(s).: MC2025-1361 and K2025-1361; Filing Title: USPS Request to Add Priority Mail & USPS Ground Advantage Contract 733 to the Competitive Product List and Notice of Filing Materials Under Seal; Filing Acceptance Date: May 6, 2025; Filing Authority: 39 U.S.C. 3642, 39 CFR 3035.105, and 39 CFR 3041.310; Public Representative: Kenneth Moeller; Comments Due: May 14, 2025.
7. Docket No(s).: MC2025-1362 and K2025-1362; Filing Title: USPS Request to Add Priority Mail & USPS Ground Advantage Contract 734 to the Competitive Product List and Notice of Filing Materials Under Seal; Filing Acceptance Date: May 6, 2025; Filing Authority: 39 U.S.C. 3642, 39 CFR 3035.105, and 39 CFR 3041.310; Public Representative: Elsie Lee-Robbins; Comments Due: May 14, 2025.

III. Summary Proceeding(s)
None. See Section II for public proceedings.
This Notice will be published in the Federal Register .
Jennie L. Jbara,

Primary Certifying Official.
POSTAL SERVICE
International Product Change—Priority Mail Express International, Priority Mail International & First-Class Package International Service Agreement

AGENCY:
Postal Service.

ACTION:
Notice.

SUMMARY:
The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a Priority Mail Express International, Priority Mail International & First-Class Package International Service contract to the list of Negotiated Service Agreements in the Competitive Product List in the Mail Classification Schedule.

DATES:
Date of notice: May 12, 2025.

FOR FURTHER INFORMATION CONTACT:
Christopher C. Meyerson, (202) 268-7820.

SUPPLEMENTARY INFORMATION:
The United States Postal Service hereby gives notice that, pursuant to 39 U.S.C. 3642 and 3632(b)(3), on May 1, 2025, it filed with the Postal Regulatory Commission a USPS Request to Add Priority Mail Express International, Priority Mail International & First-Class Package International Service Contract 68 to Competitive Product List. Documents are available at www.prc.gov, Docket Nos. MC2025-1344 and K2025-1344.
Kevin Rayburn,

Attorney, Ethics and Legal Compliance.
SECURITIES AND EXCHANGE COMMISSION
[Investment Company Act Release No. 35575; File No. 812-15759]
Nomura Alternative Income Fund, et al.
May 7, 2025.

AGENCY:
Securities and Exchange Commission (“Commission” or “SEC”).

ACTION:
Notice.
Notice of application for an order under sections 17(d) and 57(i) of the Investment Company Act of 1940 (the “Act”) and rule 17d-1 under the Act to permit certain joint transactions otherwise prohibited by sections 17(d) and 57(a)(4) of the Act and rule 17d-1 under the Act.

Summary of Application:
Applicants request an order to permit certain business development companies (“BDCs”) and closed-end management investment companies to co-invest in portfolio companies with each other and with certain affiliated investment entities.

Applicants:
Nomura Alternative Income Fund, NAIF Splitter LLC, Nomura Capital Management LLC and Nomura Credit Opportunities Fund, LP.

Filing Dates:
The application was filed on April 21, 2025.

Hearing or Notification of Hearing:
An order granting the requested relief will be issued unless the Commission orders a hearing. Interested persons may request a hearing on any application by emailing the SEC's Secretary at Secretarys-Office@sec.gov and serving the Applicants with a copy of the request by email, if an email address is listed for the relevant Applicant below, or personally or by mail, if a physical address is listed for the relevant Applicant below. Hearing requests should be received by the Commission by 5:30 p.m. on June 2, 2025, and should be accompanied by proof of service on the Applicants, in the form of an affidavit or, for lawyers, a certificate of service. Pursuant to rule 0-5 under the Act, hearing requests should state the nature of the writer's interest, any facts bearing upon the desirability of a hearing on the matter, the reason for the request, and the issues contested. Persons who wish to be notified of a hearing may request notification by emailing the Commission's Secretary at Secretarys-Office@sec.gov.

ADDRESSES:
The Commission: Secretarys-Office@sec.gov. Applicants: Robert Stark and Neil Daniele, Nomura Capital Management LLC, Worldwide Plaza, 309 W 49th Street, New York, NY 10019; and Joshua B. Deringer, Esq., Faegre Drinker Biddle & Reath LLP, joshua.deringer@faegredrinker.com.

FOR FURTHER INFORMATION CONTACT:
Adam Large, Senior Special Counsel, Laura Solomon, Senior Counsel, or Daniele Marchesani, Assistant Chief Counsel, at (202) 551-6825 (Division of Investment Management, Chief Counsel's Office).

SUPPLEMENTARY INFORMATION:
For Applicants' representations, legal analysis, and conditions, please refer to Applicants' application, dated April 21, 2025, which may be obtained via the Commission's website by searching for the file number at the top of this document, or for an Applicant using the Company name search field, on the SEC's EDGAR system. The SEC's EDGAR system may be searched at https://www.sec.gov/edgar/searchedgar/companysearch.html. You may also call the SEC's Office of Investor Education and Advocacy at (202) 551-8090.
For the Commission, by the Division of Investment Management, under delegated authority.
Sherry R. Haywood,

Assistant Secretary.
SECURITIES AND EXCHANGE COMMISSION
Investment Company Act Release No.35578; File No. 812-15757 Varagon Capital Corporation, et al.
May 7, 2025.

AGENCY:
Securities and Exchange Commission (“Commission” or “SEC”).

ACTION:
Notice.
Notice of application for an order under sections 17(d) and 57(i) of the Investment Company Act of 1940 (the “Act”) and rule 17d-1 under the Act to permit certain joint transactions otherwise prohibited by sections 17(d) and 57(a)(4) of the Act and rule 17d-1 under the Act.

Summary of Application:
Applicants request an order to permit certain business development companies (“BDCs”) and closed-end management investment companies to co-invest in portfolio companies with each other and with certain affiliated investment entities.

Applicants:
Varagon Capital Corporation, Senior Direct Lending Program, LLC, VCC Advisors, LLC, Varagon Capital Partners, L.P., certain of their affiliated entities as described in Appendix A to the application, and certain of their wholly-owned subsidiaries as described in Appendix B to the application.

Filing Dates:
The application was filed on April 17, 2025 and amended on May 5, 2025.

Hearing or Notification of Hearing:
An order granting the requested relief will be issued unless the Commission orders a hearing. Interested persons may request a hearing on any application by e- mailing the SEC's Secretary at Secretarys-Office@sec.gov and serving the Applicants with a copy of the request by email, if an email address is listed for the relevant Applicant below, or personally or by mail, if a physical address is listed for the relevant Applicant below. Hearing requests should be received by the Commission by 5:30 p.m. on June 2, 2025, and should be accompanied by proof of service on the Applicants, in the form of an affidavit or, for lawyers, a certificate of service.Pursuant to rule 0-5 under the Act, hearing requests should state the nature of the writer's interest, any facts bearing upon the desirability of a hearing on the matter, the reason for the request, and the issues contested. Persons who wish to be notified of a hearing may request notification by emailing the Commission's Secretary at Secretarys-Office@sec.gov.

ADDRESSES:
The Commission: Secretarys-Office@sec.gov. Applicants: Afsar Farman-Farmaian, Esq., Varagon Capital Corporation, 151 West 42nd Street, 53rd Floor, New York, NY 10036, varagonlegal@man.com; Steven B. Boehm, Esq., Anne G. Oberndorf, Esq., Payam Siadatpour, Esq., Sara Sabour Nasseri, Esq., Eversheds Sutherland (US) LLP, 700 Sixth Street NW, Suite 700, Washington, DC 20001, AnneOberndorf@eversheds-sutherland.com.

FOR FURTHER INFORMATION CONTACT:
Adam Large, Senior Special Counsel, Jill Ehrlich, Senior Counsel, or Daniele Marchesani, Assistant Chief Counsel, at (202) 551-6825 (Division of Investment Management, Chief Counsel's Office).

SUPPLEMENTARY INFORMATION:
For Applicants' representations, legal analysis, and conditions, please refer to Applicants' first amended application, dated May 5, 2025, which may be obtained via the Commission's website by searching for the file number at the top of this document, or for an Applicant using the Company name search field, on the SEC's EDGAR system. The SEC's EDGAR system may be searched at https://www.sec.gov/edgar/searchedgar/companysearch.html. You may also call the SEC's Office of Investor Education and Advocacy at (202) 551-8090.
For the Commission, by the Division of Investment Management, under delegated authority.
Sherry R. Haywood,

Assistant Secretary.
SECURITIES AND EXCHANGE COMMISSION
Sunshine Act Meetings

TIME AND DATE:
2:00 p.m. on Thursday, May 15, 2025.

PLACE:
The meeting will be held via remote means and/or at the Commission's headquarters, 100 F Street NE, Washington, DC 20549.

STATUS:
This meeting will be closed to the public.

MATTERS TO BE CONSIDERED:
Commissioners, Counsel to the Commissioners, the Secretary to the Commission, and recording secretaries will attend the closed meeting. Certain staff members who have an interest in the matters also may be present.
In the event that the time, date, or location of this meeting changes, an announcement of the change, along with the new time, date, and/or place of the meeting will be posted on the Commission's website at https://www.sec.gov.
The General Counsel of the Commission, or his designee, has certified that, in his opinion, one or more of the exemptions set forth in 5 U.S.C. 552b(c)(3), (5), (6), (7), (8), 9(B) and (10) and 17 CFR 200.402(a)(3), (a)(5), (a)(6), (a)(7), (a)(8), (a)(9)(ii) and (a)(10), permit consideration of the scheduled matters at the closed meeting.
The subject matter of the closed meeting will consist of the following topics:
Institution and settlement of injunctive actions;
Institution and settlement of administrative proceedings;
Resolution of litigation claims; and
Other matters relating to examinations and enforcement proceedings.
At times, changes in Commission priorities require alterations in the scheduling of meeting agenda items that may consist of adjudicatory, examination, litigation, or regulatory matters.

CONTACT PERSON FOR MORE INFORMATION:
For further information, please contact Vanessa A. Countryman from the Office of the Secretary at (202) 551-5400.
Authority: 5 U.S.C. 552b.
Dated: May 8, 2025.
Vanessa A. Countryman,

Secretary.
SECURITIES AND EXCHANGE COMMISSION
[OMB Control No. 3235-0259]
Submission for OMB Review; Comment Request; Extension: Rule 19h-1
Upon Written Request, Copies Available From: Securities and Exchange Commission, Office of FOIA Services, 100 F Street NE, Washington, DC 20549-2736
Notice is hereby given that pursuant to the Paperwork Reduction Act of 1995 (“PRA”) (44 U.S.C. 3501 et seq. ) the Securities and Exchange Commission (“Commission”) has submitted to the Office of Management and Budget (“OMB”) a request for approval of extension of the previously approved collection of information provided for in Rule 19h-1 (17 CFR 240.19h-1), under the Securities Exchange Act of 1934 (15 U.S.C. 78a et seq. ).
Rule 19h-1 prescribes the form and content of notices and applications by self-regulatory organizations (“SROs”) regarding proposed admissions to, or continuances in, membership, participation, or association with a member of any person subject to a statutory disqualification.
The Commission uses the information provided in the submissions filed pursuant to Rule 19h-1 to review decisions by SROs to permit the entry into or continuance in the securities business of persons who have committed serious misconduct. The filings submitted pursuant to the Rule also permit inclusion of an application to the Commission for consent to associate with a member of an SRO notwithstanding a Commission order barring such association.
The Commission reviews filings made pursuant to the Rule to ascertain whether it is in the public interest to permit the employment in the securities business of persons subject to statutory disqualification. The filings contain information that is essential to the staff's review and ultimate determination on whether an association or employment is in the public interest and consistent with investor protection.
It is estimated that only one respondent will make submissions pursuant to this Rule annually. With respect to submissions for Rule 19h-1(a) notices, the staff estimates that this respondent will make a total of 38 submissions per year. The staff estimates that the average number of hours necessary to complete a submission pursuant to Rule 19h-1(a) notices is 80 hours (for a total annual burden for all respondents in the amount of 3,040 hours). With respect to submissions for Rule 19h-1(a)(4) notifications, the staff estimates that this respondent will make a total of 2 submissions per year. The staff estimates that the average number of hours necessary to complete a submission pursuant to Rule 19h-1(a)(4) notifications is 80 hours (for a total annual burden for all respondents in the amount of 160 hours). With respect to submissions for Rule 19h-1(b), the staff estimates that this respondent will make a total of 40 submissions per year. The staff estimates that the average number of hours necessary to complete a submission pursuant to Rule 19h-1(b) is 13 hours (for a total annual burden for all respondents in the amount of 520 hours). With respect to submissions for Rule 19h-1(d), the staff estimates that this respondent will make a total of 3 submissions per year. The staff estimates that the average number of hours necessary to complete a submission pursuant to Rule 19h-1(d) is 80 hours (for a total annual burden for all respondents in the amount of 240 hours). The aggregate annual burden for this respondent is thus approximately 3,960 hours (3,040 + 160 + 520 + 240).
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB Control Number.
Written comments are invited on: (a) whether this collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (b) the accuracy of the agency's estimate of the burden imposed by the collection of information; (c) ways to enhance the quality, utility, and clarity of the information collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology.
The public may view and comment on this information collection request at: https://www.reginfo.gov/public/do/PRAViewICR?ref_nbr=202502-3235-005 or send an email comment to MBX.OMB.OIRA.SEC_desk_officer@omb.eop.gov within 30 days of the day after publication of this notice by June 12, 2025.
Dated: May 7, 2025.
Sherry R. Haywood,

Assistant Secretary.
SECURITIES AND EXCHANGE COMMISSION
[Investment Company Act Release No. 35577; 812-15740]
Adams Street Private Equity Navigator Fund LLC and Adams Street Advisors, LLC
May 7, 2025.

AGENCY:
Securities and Exchange Commission (“Commission” or “SEC”).

ACTION:
Notice.
Notice of an application for an order pursuant to section 6(c) of the Investment Company Act of 1940 (the “Act”) for an exemption from sections 18(a)(2), 18(c), and 18(i) of the Act, pursuant to sections 6(c) and 23(c) of the Act for an exemption from rule 23c-3 under the Act, and pursuant to section 17(d) of the Act and rule 17d-1 thereunder.

Summary of Application:
Applicants request an order to permit certain registered closed-end investment companies to issue multiple classes of shares and to impose early withdrawal charges and asset-based distribution and/or service fees.

Applicants:
Adams Street Private Equity Navigator Fund LLC and Adams Street Advisors, LLC.

Filing Date:
The application was filed on April 1, 2025.

Hearing or Notification of Hearing:
An order granting the requested relief will be issued unless the Commission orders a hearing. Interested persons may request a hearing on any application by emailing the SEC's Secretary at Secretarys-Office@sec.gov and serving the Applicants with a copy of the request by email, if an email address is listed for the relevant Applicant below, or personally or by mail, if a physical address is listed for the relevant Applicant below. Hearing requests should be received by the Commission by 5:30 p.m. on June 2, 2025, and should be accompanied by proof of service on the Applicants, in the form of an affidavit, or, for lawyers, a certificate of service. Pursuant to rule 0-5 under the Act, hearing requests should state the nature of the writer's interest, any facts bearing upon the desirability of a hearing on the matter, the reason for the request, and the issues contested. Persons who wish to be notified of a hearing may request notification by emailing the Commission's Secretary.

ADDRESSES:
The Commission: Secretarys-Office@sec.gov. Applicants: Eric R. Mansell, Adams Street Advisors, LLC, emansell@adamsstreetpartners.com, with a copies to Nicole M. Runyan, P.C., Kirkland & Ellis LLP, nicole.runyan@kirkland.com and Brad A. Green, P.C., Kirkland & Ellis LLP, brad.green@kirkland.com.

FOR FURTHER INFORMATION CONTACT:
Trace W. Rakestraw, Senior Special Counsel, at (202) 551-6825 (Division of Investment Management, Chief Counsel's Office).

SUPPLEMENTARY INFORMATION:
For Applicants' representations, legal analysis, and conditions, please refer to Applicants' application, dated April 1, 2025, which may be obtained via the Commission's website by searching for the file number at the top of this document, or for an Applicant using the Company name search field on the SEC's EDGAR system. The SEC's EDGAR system may be searched at https://www.sec.gov/edgar/searchedgar/companysearch. You may also call the SEC's Office of Investor Education and Advocacy at (202) 551-8090.
For the Commission, by the Division of Investment Management, under delegated authority.
Sherry R. Haywood,

Assistant Secretary.
SECURITIES AND EXCHANGE COMMISSION
[Investment Company Act Release No. 35574; File No. 812-15738]
Morgan Stanley Direct Lending Fund, et al.
May 7, 2025.

AGENCY:
Securities and Exchange Commission (“Commission” or “SEC”).

ACTION:
Notice.
Notice of application for an order under sections 17(d) and 57(i) of the Investment Company Act of 1940 (the “Act”) and rule 17d-1 under the Act to permit certain joint transactions otherwise prohibited by sections 17(d) and 57(a)(4) of the Act and rule 17d-1 under the Act.

Summary of Application:
Applicants request an order to permit certain business development companies (“BDCs”) and closed-end management investment companies to co-invest in portfolio companies with each other and with certain affiliated investment entities.

Applicants:
Morgan Stanley Direct Lending Fund, SL Investment Fund II LLC, T Series Middle Market Loan Fund LLC, North Haven Private Income Fund LLC, North Haven Private Income Fund A LLC, LGAM Private Credit LLC, MS Capital Partners Adviser Inc., DLF CA SPV LLC, DLF Equity Holdings LLC, DLF SPV LLC, DLF Financing SPV LLC, T Series CA SPV LLC, T Series Equity Holdings LLC, T Series Financing SPV LLC, T Series Financing II SPV LLC, T Series Financing III SPV LLC, LGAM CA SPV LLC, 1585 Koala Holdings LLC, LGAM Financing SPV LLC, LGAM Equity Holdings LLC, PIF A CA SPV LLC, Broadway Funding Holdings II LLC, PIF A Financing SPV LLC, PIF A Equity Holdings LLC, SLIF II CA SPV LLC, SLIF II LLC, SLIF II Financing SPV LLC, SLIF II Equity Holdings LLC, PIF CA SPV LLC, Broadway Funding Holdings LLC, PIF Financing SPV LLC, PIF Financing II SPV LLC, NHPIF Equity Holdings SPV LLC, SLIC CA SPV LLC, SLIC Equity Holdings LLC, SLIC Financing SPV LLC, and an Existing Proprietary Account and certain Existing Affiliated Funds as described in Appendix A to the application.

Filing Dates:
The application was filed on March 28, 2025, and amended on April 10, 2025 and May 2, 2025.

Hearing or Notification of Hearing:
An order granting the requested relief will be issued unless the Commission orders a hearing. Interested persons may request a hearing on any application by emailing the SEC's Secretary at Secretarys-Office@sec.gov and serving the Applicants with a copy of the request by email, if an email address is listed for the relevant Applicant below, or personally or by mail, if a physical address is listed for the relevant Applicant below. Hearing requests should be received by the Commission by 5:30 p.m. on June 2, 2025, and should be accompanied by proof of service on the Applicants, in the form of an affidavit or, for lawyers, a certificate of service. Pursuant to rule 0-5 under the Act, hearing requests should state the nature of the writer's interest, any facts bearing upon the desirability of a hearing on the matter, the reason for the request, and the issues contested. Persons who wish to be notified of a hearing may request notification by emailing the Commission's Secretary at Secretarys-Office@sec.gov.

ADDRESSES:
The Commission: Secretarys-Office@sec.gov. Applicants: Orit Mizrachi, Chief Operating Officer, Morgan Stanley, orit.mizrachi@morganstanley.com, Thomas Friedman, Esq., thomas.friedmann@dechert.com, and William J. Bielefeld, Esq., william.bielefeld@dechert.com, both of Dechert LLP.

FOR FURTHER INFORMATION CONTACT:
Adam Large, Senior Special Counsel, Stephan N. Packs, Senior Counsel, or Daniele Marchesani, Assistant Chief Counsel, at (202) 551-6825 (Division of Investment Management, Chief Counsel's Office).

SUPPLEMENTARY INFORMATION:
For Applicants' representations, legal analysis, and conditions, please refer to Applicants' Second Amended and Restated Application, dated May 2, 2025, which may be obtained via the Commission's website by searching for the file number at the top of this document, or for an Applicant using the Company name search field, on the SEC's EDGAR system. The SEC's EDGAR system may be searched at www.sec.gov/edgar/searchedgar/companysearch. You may also call the SEC's Office of Investor Education and Advocacy at (202) 551-8090.
For the Commission, by the Division of Investment Management, under delegated authority.
Sherry R. Haywood,

Assistant Secretary.
SMALL BUSINESS ADMINISTRATION
Data Collection Available for Public Comments

ACTION:
60-Day notice and request for comments.

SUMMARY:
The Small Business Administration (SBA) intends to request approval, from the Office of Management and Budget (OMB) for the collection of information described below. The Paperwork Reduction Act (PRA) requires Federal agencies to publish a notice in the Federal Register concerning each proposed collection of information before submission to OMB, and to allow 60 days for public comment in response to the notice. This notice complies with that requirement.

DATES:
Submit comments on or before July 11, 2025.

ADDRESSES:
Send all comments to Michael Donadieu, Senior Examiner, Office of Investment and Innovation, Small Business Administration, Washington, DC 20416.

FOR FURTHER INFORMATION CONTACT:
Michael Donadieu, Senior Examiner, Office of Investment and Innovation, 202-205-7281, michael.donadieu@sba.gov, or Curtis B. Rich, Agency Clearance Officer, 202-205-7030, curtis.rich@sba.gov .

SUPPLEMENTARY INFORMATION:
Small Business Administration (SBA) Forms 856 and 856A are used by SBA examiners as part of their examination of licensed small business investment companies (SBICs). This information collection obtains representations from an SBIC's management regarding certain obligations, transactions and relationships of the SBIC and helps SBA to evaluate the SBIC's financial condition and compliance with applicable laws and regulations.

Solicitation of Public Comments
SBA is requesting comments on (a) Whether the collection of information is necessary for the agency to properly perform its functions; (b) whether the burden estimates are accurate; (c) whether there are ways to minimize the burden, including through the use of automated techniques or other forms of information technology; and (d) whether there are ways to enhance the quality, utility, and clarity of the information.

Summary of Information Collection
OMB Control Number: 3245-0118.
Title: Disclosures Statement Leveraged Licensees; Disclosure Statement Non-leveraged Licensees.
Description of Respondents: SBA Examiners.
Form Numbers: SBA Forms 856 and 856A.
Total Estimated Annual Responses: 598.
Total Estimated Annual Hour Burden: 276.
Alethea Ten Eyck-Sanders,

Agency Clearance Officer.
DEPARTMENT OF STATE
[Public Notice: 12716]
Annual Determination and Certification of Shrimp-Harvesting Nations

SUMMARY:
On April 11, 2025, the Department of State certified to Congress that wild-caught shrimp harvested in the following nations and Hong Kong are eligible to enter the United States: Argentina, the Bahamas, Belgium, Belize, Canada, Chile, Colombia, Costa Rica, Denmark, the Dominican Republic, Ecuador, El Salvador, Estonia, Fiji, Gabon, Germany, Guatemala, Guyana, Honduras, Iceland, Ireland, Jamaica, Mexico, the Netherlands, New Zealand, Nicaragua, Nigeria, Norway, Oman, Panama, Russia, Sri Lanka, Suriname, Sweden, the United Kingdom, and Uruguay. The Department of State determined that wild-caught shrimp harvested in particular fisheries of certain nations and products from that shrimp are eligible to enter the United States: Australia (Northern Prawn Fishery, the Queensland East Coast Trawl Fishery, the Spencer Gulf, and the Torres Strait Prawn Fishery), France (French Guiana), Italy (giant red shrimp), Japan (shrimp baskets in Hokkaido), Republic of Korea (mosquito nets), and Spain (Mediterranean red shrimp). For nations, economies, and fisheries not listed above, only shrimp harvested from aquaculture and products from that shrimp are eligible to enter the United States. Shrimp and products from shrimp (products containing shrimp) imports into the United States must be accompanied by the DS-2031 Shrimp Exporter's/Importer's Declaration.

DATES:
This determination and certification notice is effective on May 12, 2025.

FOR FURTHER INFORMATION CONTACT:
Jared Milton, Section 609 Program Manager, Office of Marine Conservation, Bureau of Oceans and International Environmental and Scientific Affairs, Department of State, 2201 C Street NW, Washington, DC 20520-2758; telephone: (202) 647-3263; email: DS2031@state.gov.

SUPPLEMENTARY INFORMATION:
Section 609 of Public Law 101-162 (“Sec. 609”) prohibits imports of wild-caught shrimp or products from shrimp harvested with commercial fishing technology unless the President certifies to the Congress by May 1, 1991, and annually thereafter, that either: (1) the harvesting nation has adopted a regulatory program governing the incidental taking of relevant species of sea turtles in the course of commercial shrimp harvesting that is comparable to that of the United States and that the average rate of that incidental taking by the vessels of the harvesting nation is comparable to the average rate of incidental taking of sea turtles by United States vessels in the course of such harvesting; or (2) the particular fishing environment of the harvesting nation does not pose a threat of the incidental taking of sea turtles in the course of shrimp harvesting. The President has delegated the authority to make this certification to the Secretary of State (“Secretary”) who further delegated the authority within the Department of State (“Department”). The Revised Guidelines for the Implementation of Sec. 609 were published in the Federal Register on July 8, 1999, at 64 FR 36946.
On April 11, 2025, the Department certified to Congress the following nations pursuant to section 609(b)(2)(A) and (B) on the basis that they have adopted a regulatory program governing the incidental taking of relevant species of sea turtles in the course of commercial shrimp harvesting that is comparable to that of the United States and that the average rate of that incidental taking by the vessels of the harvesting nation is comparable to the average rate of incidental taking of such sea turtles by United States vessels in the course of such harvesting: Colombia, Ecuador, El Salvador, Gabon, Guatemala, Guyana, Honduras, Mexico, Nicaragua, Nigeria, Panama, and Suriname. The Department also certified pursuant to section 609(b)(2)(C) several shrimp-harvesting nations and one economy as having fishing environments that do not pose a threat to sea turtles, including the following nations with shrimping grounds only in cold waters where the risk of taking sea turtles is negligible: Argentina, Belgium, Canada, Chile, Denmark, Estonia, Germany, Iceland, Ireland, the Netherlands, New Zealand, Norway, Russia, Sweden, the United Kingdom, and Uruguay. Additionally, the Department certified pursuant to section 609(b)(2)(C) that the following nations and Hong Kong only harvest shrimp using small boats with crews of less than five that only use manual rather than mechanical means to retrieve nets or catch shrimp using other methods that do not pose a threat of incidental taking of sea turtles: the Bahamas, Belize, Costa Rica, the Dominican Republic, Fiji, Jamaica, Oman, and Sri Lanka.
The Department has certified the above listed nations and Hong Kong pursuant to Sec. 609, and shrimp and products from shrimp are eligible for importation into the United States utilizing the Shrimp Exporter's/Importer's Declaration (“DS-2031”) Box 7(B) provision for shrimp “harvested in the waters of a nation currently certified pursuant to Section 609 of Public Law 101-162.”
The Department suspended the certification of Peru (effective for Peru with Dates of Export June 1st, 2025, and after) because its sea turtle protection program is no longer comparable to that of the United States.
Shrimp harvested with turtle excluder devices (“TEDs”) and products from that shrimp in an uncertified nation may, under specific circumstances, be eligible for importation into the United States under the DS-2031 Box 7(A)(2) provision for shrimp “harvested using TEDs comparable in effectiveness to those in the United States, as determined by the U.S. Department of State.” Use of this provision requires that the Secretary or his or her delegate determine in advance that the government of the harvesting nation has put in place adequate procedures to monitor the use of TEDs in the specific fishery in question and to ensure the accurate completion of the DS-2031 forms. At this time, the Department has determined that only shrimp and products from shrimp harvested in the Northern Prawn Fishery, the Queensland East Coast Trawl Fishery, and the Torres Strait Prawn Fishery in Australia, and in the French Guiana domestic trawl fishery of France are eligible for entry under this provision. A responsible government official of Australia or France must sign in Block 8 of the DS-2031 form accompanying these imports into the United States.
In addition, shrimp and products of shrimp harvested in a manner or under circumstances determined by the Department of State not to pose a threat of the incidental taking of sea turtles may, under specific circumstances, be eligible for importation into the United States under the DS-2031 Box 7(A)(4) provision for shrimp “harvested in a manner or under circumstances not to pose a threat of the incidental taking of sea turtles, as determined by the U.S. Department of State.” The Department has determined that shrimp and products from shrimp harvested in the Spencer Gulf region in Australia, with shrimp baskets in Hokkaido, Japan, with “mosquito” nets in the Republic of Korea, Mediterranean red shrimp ( Aristeus antennatus ) and products from that shrimp harvested in the Mediterranean Sea in Spain, and giant red shrimp ( Aristaeomorpha foliacea ) and products from that shrimp harvested in Italy may be imported into the United States under the DS-2031 Box 7(A)(4) provision. A responsible government official of Australia, Japan, the Republic of Korea, Spain, or Italy must sign in Block 8 of the DS-2031 form accompanying these imports into the United States.
A completed DS-2031 Shrimp Exporter's/Importer's Declaration must accompany all imports of shrimp and products from shrimp into the United States. The DS-2031 form is accessible at the following link: https://eforms.state.gov/Forms/ds2031.PDF. Importers of shrimp and products from shrimp harvested in certified nations and Hong Kong must either provide the DS-2031 form to Customs and Border Protection at the port of entry or provide the information required by the DS-2031 through the Automated Commercial Environment. Importers of shrimp and products from shrimp from certified nations and Hong Kong should mark the box 7(B) provision for shrimp “harvested in the waters of a nation currently certified pursuant to Section 609 of Public Law 101-162” regardless of whether the shrimp is wild-caught or the product of aquaculture. DS-2031 forms accompanying all imports of shrimp and products from shrimp harvested in uncertified nations and economies, to include all fisheries with determinations, must be originals with Box 7(A)(1), 7(A)(2), or 7(A)(4) checked, consistent with the form's instructions with regard to the method of harvest of the shrimp and based on any relevant prior determinations by the Department, and signed by the exporter from the harvesting nation and a responsible government official of the harvesting nation prior to export from the harvesting nation.
The DS-2031 form must accompany the shipment through all stages of the export process, including any transformation of the original product and any shipment through any intermediary nation. The Department did not determine that shrimp or products from shrimp harvested in a manner as described in 7(A)(3) in any uncertified nation or economy is eligible to enter the United States. Consequently, 7(A)(3) may not be marked on any DS-2031 form.
The importation of wild-caught shrimp or products from that shrimp from any nation or fishery without a certification or determination will not be allowed.
The Department has communicated these certifications and determinations under Sec. 609 to the Offices of Field Operations and of Trade at U.S. Customs and Border Protection.
David F. Hogan,

Director, Office of Marine Conservation, Department of State.
DEPARTMENT OF STATE
[Public Notice: 12728]
Notice of Determinations; Culturally Significant Objects Being Imported for Exhibition—Determinations: Exhibition of Certain Armor Loans From the Kunsthistorisches Museum Wien

SUMMARY:
Notice is hereby given of the following determinations: I hereby determine that certain objects being imported from abroad pursuant to an agreement with their foreign owner or custodian for temporary exhibition or display at The Cleveland Museum of Art, Cleveland, Ohio, and at possible additional exhibitions or venues yet to be determined, are of cultural significance, and, further, that their temporary exhibition or display within the United States as aforementioned is in the national interest. I have ordered that Public Notice of these determinations be published in the Federal Register .

FOR FURTHER INFORMATION CONTACT:
Reed Liriano, Program Coordinator, Office of the Legal Adviser, U.S. Department of State (telephone: 202-632-6471; email: section2459@state.gov ). The mailing address is U.S. Department of State, L/PD, 2200 C Street NW (SA-5), Suite 5H03, Washington, DC 20522-0505.

SUPPLEMENTARY INFORMATION:
The foregoing determinations were made pursuant to the authority vested in me by the Act of October 19, 1965 (79 Stat. 985; 22 U.S.C. 2459), Executive Order 12047 of March 27, 1978, the Foreign Affairs Reform and Restructuring Act of 1998 (112 Stat. 2681, et seq.; 22 U.S.C. 6501 note, et seq. ), Delegation of Authority No. 234 of October 1, 1999, Delegation of Authority No. 236-3 of August 28, 2000, and Delegation of Authority No. 574 of March 4, 2025.
Mary C. Miner,

Managing Director for Professional and Cultural Exchanges, Bureau of Educational and Cultural Affairs, Department of State.
DEPARTMENT OF TRANSPORTATION
Federal Aviation Administration
Notice of Availability of the Final Tiered Environmental Assessment and Mitigated Finding of No Significant Impact and Record of Decision for SpaceX Starship/Super Heavy Vehicle Increased Cadence at the SpaceX Boca Chica Launch Site in Cameron County, Texas

AGENCY:
Federal Aviation Administration (FAA), Department of Transportation (DOT).

ACTION:
Notice of availability.

SUMMARY:
The FAA is announcing the availability of the Final Tiered Environmental Assessment and Mitigated Finding of No Significant Impact and Record of Decision for SpaceX Starship/Super Heavy Vehicle Increased Cadence at the SpaceX Boca Chica Launch Site in Cameron County, Texas (Final Tiered EA and Mitigated FONSI/ROD).

SUPPLEMENTARY INFORMATION:
The FAA is the lead agency. The National Aeronautics and Space Administration, the National Park Service, the U.S. Coast Guard, and the U.S. Fish and Wildlife Service are cooperating agencies due to their special expertise and/or jurisdiction. The FAA evaluated SpaceX's proposal to increase the launch and landing cadence of the Starship/Super Heavy launch vehicle at its existing Boca Chica Launch Site in Cameron County, Texas. SpaceX must obtain a modification of their existing vehicle operator license from the FAA to operate Starship/Super Heavy at an increased cadence. Under the Proposed Action, the FAA would modify SpaceX's existing vehicle operator license to authorize SpaceX to increase the cadence of the Starship/Super Heavy launch program at the Boca Chica vertical launch area (VLA) in Cameron County, Texas to up to 25 annual launches, up to 25 annual landings of Starship (second stage), up to 25 annual landings of Super Heavy (first stage) and make vehicle and operational upgrades. Up to three launches (of the total 25) would occur during nighttime hours from the VLA. Landings at the VLA would only take place during the daytime, with up to 22 Starship and 22 Super Heavy landings at the VLA. Daytime landings of either vehicle may also take place offshore as well. Up to three landings of Starship and three offshore landings of Super Heavy may occur at night. SpaceX would also conduct up to 90 seconds of licensed daytime Starship static fire tests and 70 seconds of licensed daytime Super Heavy static fire tests a year. The federal action also includes the FAA's issuance of temporary airspace closures.
The Final Tiered EA evaluated the potential environmental impacts of the Proposed Action and the No Action Alternative. Under the No Action Alternative, the FAA would not modify a license to SpaceX to allow for increased launch and landing cadence from the Boca Chica launch site. As assessed in the 2022 Final Programmatic Environmental Assessment (PEA) for the SpaceX Starship/Super Heavy Launch Vehicle Program at the SpaceX Boca Chica Launch Site in Cameron County, Texas and subsequent Written Re-evaluations (WRs), SpaceX could conduct up to five annual Starship and up to five annual Super Heavy launches (with Starship attached as the second stage of the launch vehicle), up to ten annual Starship landings, and up to five annual Super Heavy landings. The Starship/Super Heavy launch vehicles would not be modified and would remain the same as assessed in the 2022 PEA. This alternative provides the basis for comparing the environmental consequences of the Proposed Action.
The FAA published the Draft EA for a 30-day public comment period that began on July 29, 2024, and ended on August 29, 2024. The FAA issued a Revised Draft EA and initiated a new 45-day public comment period that began on November 20, 2024, and ended on January 17, 2025. The FAA received thousands of public comments on the Revised Draft EA. The revised Draft Tiered EA was revised based on public comments, and the Final Tiered EA includes responses to substantive comments. The FAA has posted the Final Tiered EA and Mitigated FONSI/ROD on the FAA Office of Commercial Space Transportation website: https://www.faa.gov/space/stakeholder_engagement/spacex_starship/.
Authority: The National Environmental Policy Act of 1969, as amended (NEPA; 42 U.S.C. 4321-4336) and FAA Order 1050.1F, Environmental Impacts: Policies and Procedures.
Issued in Washington, DC, on: May 6, 2025.
Stacey Molinich Zee,

Manager, Operations Support Branch.
DEPARTMENT OF TRANSPORTATION
Federal Highway Administration
Notice of Final Federal Agency Actions on Proposed Transportation Project in Utah

AGENCY:
Federal Highway Administration (FHWA), Department of Transportation.

ACTION:
Notice of limitation on claims for judicial review.

SUMMARY:
The FHWA, on behalf of the Utah Department of Transportation (UDOT), is issuing this notice to announce actions taken by UDOT and other Federal agencies that are final agency actions. These actions relate to the proposed Mountain View Corridor—2100 North Freeway project in Utah County, Utah.

DATES:
By this notice, the FHWA, on behalf of UDOT, is advising the public of final agency actions subject to 23 U.S.C. 139(l)(1). A claim seeking judicial review of the Federal Agency actions on the listed highway project will be barred unless the claim is filed on or before October 9, 2025. If the Federal law that authorizes judicial review of a claim provides a time period of less than 150 days for filing such claim, then that shorter time period still applies.

ADDRESSES:
The Environmental Impact Statement (EIS) Re-evaluation, Record of Decision and additional project documents can be viewed and downloaded from the project website at: https://udotinput.utah.gov/2100North or by contacting UDOT Environmental Services, 4501 South 2700 West, P.O. Box 148450, Salt Lake City, UT 84114-8450, during normal business hours are 8 a.m. to 5 p.m. (Eastern Standard Time), Monday through Friday, except State holidays.

FOR FURTHER INFORMATION CONTACT:
Carissa Watanabe, Environmental Program Manager, UDOT Division of Environmental Services; 503-939-3798; cwatanabe@utah.gov.

SUPPLEMENTARY INFORMATION:
Effective January 17, 2017, and as subsequently renewed on May 26, 2022, the FHWA assigned, and the UDOT assumed, environmental responsibilities for this project pursuant to 23 U.S.C. 327. Notice is hereby given that UDOT and other Federal agencies have taken final agency actions subject to 23 U.S.C. 139(l)(1) by issuing licenses, permits, or approvals for the proposed improvement highway project. The actions by UDOT and other Federal agencies on the project, and the laws under which such actions were taken are described in the EIS Re-evaluation and Record of Decision approved on April 18, 2025, and in other project records for the listed project.
The project subject to this notice is:
Project Location: The project limits include State Route (SR) 194 (2100 North) from SR-85 to Interstate 15 in Utah County, Utah. The project will construct approximately three miles of new highway on 2100 North; a new interchange system at Interstate 15; auxiliary lanes and ramps to the existing frontage road system; and new active transportation facilities.
Project Actions: This notice applies to the EIS Re-evaluation, Record of Decision and all other Federal agency licenses, permits, or approvals for the listed project as of the issuance date of this notice including but not limited to the Section 4(f) Evaluation and all laws under which such actions were taken, including but not limited to:
1. General: National Environmental Policy Act (NEPA) [42 U.S.C. 4321 et seq. ]; Federal-Aid Highway Act (FAHA) [23 U.S.C. 109 and 23 U.S.C. 128]; 23 CFR part 771.
2. Air: Clean Air Act (CAA) [42 U.S.C. 7401-7671(q)], with the exception of project level conformity determinations [42 U.S.C. 7506].
3. Noise: Noise Control Act of 1972 [42 U.S.C. 4901-4918]; 23 CFR part 772.
4. Land: Section 4(f) of the Department of Transportation Act of 1966 [23 U.S.C. 138 and 49 U.S.C. 303]; 23 CFR part 774; Land and Water Conservation Fund (LWCF) [54 U.S.C. 200302-200310].
5. Wildlife: Endangered Species Act (ESA) [16 U.S.C. 1531-1544 and 1536]; Fish and Wildlife Coordination Act [16 U.S.C. 661-667(d)]; Migratory Bird Treaty Act (MBTA) [16 U.S.C. 703-712].
6. Historic and Cultural Resources: Section 106 of the National Historic Preservation Act of 1966, as amended [54 U.S.C. 3006101 et seq. ]; Archaeological Resources Protection Act of 1979 (ARPA) [16 U.S.C. 470(aa)-470(II)]; Preservation of Historical and Archaeological Data [54 U.S.C.312501-312508].
7. Social and Economic: Civil Rights Act of 1964 [42 U.S.C. 2000 d-2000d-1]; American Indian Religious Freedom Act [42 U.S.C. 1996]; Farmland Protection Policy Act (FPPA) [7 U.S.C. 4201-4209].
8. Wetlands and Water Resources: Clean Water Act (Section 319, Section 401, Section 404) [33 U.S.C. 1251-1387]; Safe Drinking Water Act (SDWA) [42 U.S.C. 300f-300j-26]; Rivers and Harbors Act of 1899 [33 U.S.C. 401-406]; Emergency Wetlands Resources Act [16 U.S.C. 3921, 3931]; Wetlands Mitigation, [23 U.S.C. 119(g) and 133(b)(3)]; Flood Disaster Protection Act [42 U.S.C. 4001-4130].
9. Hazardous Materials: Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA) [42 U.S.C. 9601-9675]; Superfund Amendments and Reauthorization Act of 1986 (SARA); Resource Conservation and Recovery Act (RCRA) [42 U.S.C. 6901-6992(k)].
10. Executive Orders: E.O. 11990 Protection of Wetlands; E.O. 11988 Floodplain Management; E.O. 11593 Protection and Enhancement of Cultural Resources; E.O. 13007 Indian Sacred Sites; E.O. 13287 Preserve America; E.O. 11514 Protection and Enhancement of Environmental Quality; E.O. 13112 Invasive Species.
(Catalog of Federal Domestic Assistance Program Number 20.205, Highway Planning and Construction. The regulations implementing Executive Order 12372 regarding intergovernmental consultation on Federal programs and activities apply to this program.)
(Authority: 23 U.S.C. 139(l)(1)).
Issued on: May 5, 2025.
Ivan Marrero,

Division Administrator, Federal Highway Administration.
DEPARTMENT OF TRANSPORTATION
Federal Motor Carrier Safety Administration
[Docket No. FMCSA-2025-0093]
Hours of Service of Drivers; Northern Clearing, Inc.'s Application for Exemption

AGENCY:
Federal Motor Carrier Safety Administration (FMCSA), Department of Transportation (DOT).

ACTION:
Notice of application for exemption; request for comments.

SUMMARY:
FMCSA requests public comment on Northern Clearing Inc.'s (Northern Clearing) application for an exemption from the hours-of-service (HOS) maximum driving time limits for drivers of property-carrying commercial motor vehicles (CMV). The requested exemption would allow Northern Clearing to provide continued restoration, clean up, and re-construction services in North Carolina, under the same conditions set out in the FMCSA Regional Emergency Declaration and Extension of Emergency Declarations Number 2024-008, which was in effect from October 4 through December 26, 2024.

DATES:
Comments must be received on or before June 11, 2025.

ADDRESSES:
You may submit comments identified by Docket Number FMCSA-2025-0093 by any of the following methods:
• Federal eRulemaking Portal: www.regulations.gov. See the Public Participation and Request for Comments section below for further information.
• Mail: Dockets Operations, U.S. Department of Transportation, 1200 New Jersey Avenue SE, West Building, Ground Floor, Washington, DC 20590-0001.
• Hand Delivery or Courier: 1200 New Jersey Avenue SE, West Building, Ground Floor, Washington, DC 20590-0001, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays.
• Fax: (202) 493-2251.
To avoid duplication, please use only one of these four methods. Each submission must include the Agency name and the docket number (FMCSA-2025-0093) for this notice. Note that DOT posts all comments received without change to www.regulations.gov, including any personal information included in a comment. Please see the Privacy Act heading below.
Docket: To view any documents mentioned as being available in the docket, go to https://www.regulations.gov/docket/FMCSA-2025-0093/document and choose the document to review. To view comments, click this notice, then click “Browse Comments.” If you do not have access to the internet, you may view the docket online by visiting Dockets Operations on the ground floor of the West Building, 1200 New Jersey Avenue SE, Washington, DC 20590-0001, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. To be sure someone is there to help you, please call (202) 366-9317 or (202) 366-9826 before visiting Dockets Operations.
Privacy Act: In accordance with 49 U.S.C. 31315(b), DOT solicits comments from the public to better inform its exemption process. DOT posts these comments, including any personal information the commenter provides, to www.regulations.gov, as described in the system of records notice DOT/ALL-14 FDMS, which can be reviewed under the “Department Wide System of Records Notices” link at https://www.transportation.gov/individuals/privacy/privacy-act-system-records-notices. The comments are posted without edit and are searchable by the name of the submitter.

FOR FURTHER INFORMATION CONTACT:
Pearlie Robinson, Driver and Carrier Operations Division; Office of Carrier, Driver and Vehicle Safety Standards, FMCSA; 1200 New Jersey Avenue SE, Washington, DC 20590-0001; (202) 366-4225; pearlie.robinson@dot.gov. If you have questions on viewing or submitting material to the docket, contact Dockets Operations at (202) 366-9826.

SUPPLEMENTARY INFORMATION:

I. Public Participation and Request for Comments
FMCSA encourages you to participate by submitting comments and related materials.

A. Submitting Comments
If you submit a comment, please include the docket number for this notice (FMCSA-2025-0093), indicate the specific section of this document to which the comment applies, and provide a reason for your suggestions or recommendations. You may submit your comments and material online or by fax, mail, or hand delivery, but please use only one of these means. FMCSA recommends that you include your name and a mailing address, an email address, or a phone number in the body of your document so the Agency can contact you if it has questions regarding your submission.
To submit your comment online, go to https://www.regulations.gov/docket/FMCSA-2025-0093/document, click on this notice, click “Comment,” and type your comment into the text box on the following screen.
If you submit your comments by mail or hand delivery, submit them in an unbound format, no larger than 8 1/2 by 11 inches, suitable for copying and electronic filing.
FMCSA will consider all comments and material received during the comment period. Comments received after the comment closing date will be filed in the public docket and will be considered to the extent practicable.

B. Confidential Business Information (CBI)
CBI is commercial or financial information that is both customarily and actually treated as private by its owner. Under the Freedom of Information Act (5 U.S.C. 552), CBI is exempt from public disclosure. If your comments responsive to the notice contain commercial or financial information that is customarily treated as private, that you actually treat as private, and that is relevant or responsive to the notice, it is important that you clearly designate the submitted comments as CBI. Please mark each page of your submission that constitutes CBI as “PROPIN” to indicate it contains proprietary information. FMCSA will treat such marked submissions as confidential under the Freedom of Information Act, and they will not be placed in the public docket of the notice. Submissions containing CBI should be sent to Brian Dahlin, Chief, Regulatory Evaluation Division, Office of Policy, FMCSA, 1200 New Jersey Avenue SE, Washington, DC 20590-0001 or via email at brian.g.dahlin@dot.gov. At this time, you need not send a duplicate hardcopy of your electronic CBI submissions to FMCSA headquarters. Any comments FMCSA receives not specifically designated as CBI will be placed in the public docket for this notice.

II. Legal Basis
FMCSA has authority under 49 U.S.C. 31136(e) and 31315(b) to grant exemptions from Federal Motor Carrier Safety Regulations (FMCSRs). FMCSA must publish a notice of each exemption request in the Federal Register (49 CFR 381.315(a)). The Agency must provide the public an opportunity to inspect the information relevant to the application, including any safety analyses that have been conducted. The Agency must provide an opportunity for public comment on the request.
The Agency reviews the application, safety analyses, and public comments submitted and determines whether granting the exemption would likely maintain a level of safety equivalent to, or greater than, the level that would be achieved absent such exemption pursuant to the standard in 49 U.S.C 31315(b)(1). The Agency must publish its decision in the Federal Register (49 CFR 381.315(b)). If granted, the notice will identify the regulatory provision from which the applicant will be exempt, the effective period, and all terms and conditions of the exemption (49 CFR 381.315(c)(1)). If the exemption is denied, the notice will explain the reason for the denial (49 CFR 381.315(c)(2)). The exemption may be renewed (49 CFR 381.300(b)).

III. Applicant's Request
Northern Clearing is requesting an exemption from the HOS maximum driving time limits for property-carrying vehicles in 49 CFR 395.3 for its CMV drivers. The exemption would allow continued support for restoration, clean up, and re-construction efforts in North Carolina under the FMCSA Regional Emergency Declaration and Extension of Emergency Declarations Number 2024-008, which was in effect from October 4 through December 26, 2024. The original Declaration granted regulatory relief for CMV operations providing direct assistance in emergency response, regardless of trip origin. However, this relief does not cover long-term infrastructure rehabilitation once the immediate threat has passed.
Under the requested exemption, Northern Clearing would follow the conditions outlined in Emergency Declaration No. 2024-008 and align its HOS practices with the “utility service vehicle” exemption in 49 CFR 395.1(n). A copy of the application for exemption is available for review in the docket for this notice.

IV. Request for Comments
In accordance with 49 U.S.C. 31315(b), FMCSA requests public comment from all interested persons on Northern Clearing's application for exemption from 49 CFR part 395. All comments received before the close of business on the comment closing date indicated at the beginning of this notice will be considered and will be available for examination in the docket at the location listed under the Addresses section of this notice. Comments received after the comment closing date will be filed in the public docket and will be considered to the extent practicable. In addition to late comments, FMCSA will also continue to file in the public docket relevant information that becomes available after the comment closing date. Interested persons should continue to examine the public docket for new material.
Larry W. Minor,

Associate Administrator for Policy.
DEPARTMENT OF TRANSPORTATION
Federal Motor Carrier Safety Administration
[Docket No. FMCSA-2017-0133]
Commercial Driver's License: U.S. Custom Harvesters, Inc.; Application for Exemption Renewal

AGENCY:
Federal Motor Carrier Safety Administration (FMCSA), Department of Transportation (DOT).

ACTION:
Notice of application for exemption renewal; request for comments.

SUMMARY:
FMCSA announces that the U.S. Custom Harvesters, Inc. (USCHI) has requested a renewal of the exemption from the “K” intrastate restriction on commercial driver's licenses (CDLs) held by custom harvester drivers under the age of 21 operating in interstate commerce. FMCSA's regulations currently provide an exception to the minimum age requirements for drivers of commercial motor vehicles (CMV) controlled and operated by a person engaged in interstate custom harvesting. However, under the Agency's CDL regulations, States must include an intrastate-only (or “K”) restriction for these drivers. FMCSA requests public comment on USCHI's application to renew its exemption.

DATES:
Comments must be received on or before June 11, 2025.

ADDRESSES:
You may submit comments identified by Federal Docket Management System (FDMS) Number FMCSA-2017-0133 by any of the following methods:
• Federal eRulemaking Portal:
www.regulations.gov. See the Public Participation and Request for Comments section below for further information.
• Mail: Dockets Operations, U.S. Department of Transportation, 1200 New Jersey Avenue SE, West Building, Ground Floor, Washington, DC 20590-0001.
• Hand Delivery or Courier: 1200 New Jersey Avenue SE, West Building, Ground Floor, Washington, DC 20590-0001, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays.
• Fax: (202) 493-2251.
To avoid duplication, please use only one of these four methods. Each submission must include the Agency name and the docket number (FMCSA-2017-0133) for this notice. Note that DOT posts all comments received without change to www.regulations.gov, including any personal information included in a comment. Please see the Privacy Act heading below.
Docket: To view any documents mentioned as being available in the docket, go to https://www.regulations.gov/docket/FMCSA-2017-0133/document and choose the document to review. To view comments, click this notice, then click “Browse Comments.” If you do not have access to the internet, you may view the docket in person by visiting Dockets Operations on the ground floor of the DOT West Building, 1200 New Jersey Avenue SE, Washington, DC 20590-0001, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. To be sure someone is there to help you, please call (202) 366-9317 or (202) 366-9826 before visiting Dockets Operations.
Privacy Act: In accordance with 49 U.S.C. 31315(b), DOT solicits comments from the public to better inform its exemption process. DOT posts these comments, including any personal information the commenter provides, to www.regulations.gov, as described in the system of records notice DOT/ALL-14 FDMS (Federal Docket Management System (FDMS)), which can be reviewed at https://www.transportation.gov/individuals/privacy/privacy-act-system-records-notices. The comments are posted without edit and are searchable by the name of the submitter.

FOR FURTHER INFORMATION CONTACT:
Richard Clemente, Driver and Carrier Operations Division; Office of Carrier, Driver and Vehicle Safety Standards, FMCSA; (202) 366-2722; richard.clemente@dot.gov. If you have questions on viewing or submitting material to the docket, contact Dockets Operations at (202) 366-9826.

SUPPLEMENTARY INFORMATION:

I. Public Participation and Request for Comments
FMCSA encourages you to participate by submitting comments and related materials.

A. Submitting Comments
If you submit a comment, please include the docket number for this notice (FMCSA-2017-0133), indicate the specific section of this document to which the comment applies, and provide a reason for suggestions or recommendations. You may submit your comments and material online or by fax, mail, or hand delivery, but please use only one of these means. FMCSA recommends that you include your name and a mailing address, an email address, or a phone number in the body of your document so the Agency can contact you if it has questions regarding your submission.
To submit your comment online, go to www.regulations.gov, insert the docket number (FMCSA-2017-0133) in keyword box, and click on this notice, click “Comment,” and type your comment into the text box on the following screen.
If you submit your comments by mail or hand delivery, submit them in an unbound format, no larger than 8 1/2 by 11 inches, suitable for copying and electronic filing.
FMCSA will consider all comments and material received during the comment period. Comments received after the comment closing date will be filed in the public docket and will be considered to the extent practicable.

B. Confidential Business Information (CBI)
CBI is commercial or financial information that is both customarily and actually treated as private by its owner. Under the Freedom of Information Act (5 U.S.C. 552), CBI is exempt from public disclosure. If your comments responsive to the notice contain commercial or financial information that is customarily treated as private, that you actually treat as private, and that is relevant or responsive to the notice, it is important that you clearly designate the submitted comments as CBI. Please mark each page of your submission that constitutes CBI as “PROPIN” to indicate it contains proprietary information. FMCSA will treat such marked submissions as confidential under the Freedom of Information Act, and they will not be placed in the public docket of the notice. Submissions containing CBI should be sent to Brian Dahlin brian.g.dahlin@dot.gov, Chief, Regulatory Evaluation Division, Office of Policy, FMCSA, 1200 New Jersey Avenue SE, Washington, DC 20590-0001 or via email at brian.g.dahlin@dot.gov. At this time, you need not send a duplicate hardcopy of your electronic CBI submissions to FMCSA headquarters. Any comments FMCSA receives not specifically designated as CBI will be placed in the public docket for this notice.

II. Legal Basis
FMCSA has authority under 49 U.S.C. 31136(e) and 31315(b) to grant exemptions from the Federal Motor Carrier Safety Regulations. FMCSA must publish a notice of each exemption request in the Federal Register (49 CFR 381.315(a)). The Agency must provide the public an opportunity to inspect the information relevant to the application, including the applicant's safety analysis. The Agency must provide an opportunity for public comment on the request.
The Agency reviews the application, safety analyses, and public comments submitted and determines whether granting the exemption would likely achieve a level of safety equivalent to, or greater than, the level that would be achieved absent such exemption pursuant to the standard set forth in 49 U.S.C. 31315(b)(1). The Agency must publish its decision in the Federal Register (49 CFR 381.315(b)). If granted, the notice will identify the regulatory provision from which the applicant will be exempt, the effective period, and all terms and conditions of the exemption (49 CFR 381.315(c)(1)). If the exemption is denied, the notice will explain the reason for the denial (49 CFR 381.315(c)(2)). The exemption may be renewed (49 CFR 381.300(b)).

III. Applicant's Request
USCHI requested a renewal of its current exemption. USCHI stated that it frequently employs drivers younger than 21 years of age, who are issued CDLs with a “K” restriction. Under an exception that has been in place since 1971, the requirement that commercial motor vehicle (CMV) drivers must be at least 21-years old does not apply to a someone who drives a CMV in interstate commerce while engaged in custom-harvesting operations, provided that certain conditions are met (49 CFR 391.2(a)). Under the exemption in section 391.2(a), drivers under 21 are therefore allowed to drive in interstate custom harvesting operations, but remain subject to the the “K” restriction which makes their licenses invalid outside the State of issuance. The current exemption allows holders of “K”-restricted CDLs to operate in interstate commerce.
USCHI states that, even though CMV drivers engaged in custom harvesting are excepted from the 21-year-old requirement, they are frequently cited during roadside inspections because of the presence of the “K” restriction on their licenses. USCHI states that this issue negatively impacts the safety records of drivers and employers. USCHI asks the Agency to renew its exemption, subject to terms and conditions, that would allow law enforcement officers to determine that the driver is operating in custom harvester operations. For example, USCHI proposes that the driver be required to provide at least three methods of verification while en route.
A copy of USCHI's request for an exemption renewal is available for review in the docket for this notice.

IV. Request for Comments
In accordance with 49 U.S.C. 31315(b), FMCSA requests public comment from all interested persons on USCHI's application for an exemption from the “K” intrastate restriction on CDLs held by custom harvester drivers under the age of 21 operating in interstate commerce (49 CFR 391.2; 49 CFR 383.23(a)(2) and 49 CFR 383.153(a)(10)(vii)). All comments received before the close of business on the comment closing date will be considered and will be available for examination in the docket at the location listed under the ADDRESSES section of this notice. Comments received after the comment closing date will be filed in the public docket and will be considered to the extent practicable. In addition to late comments, FMCSA will also continue to file, in the public docket, relevant information that becomes available after the comment closing date. Interested persons should continue to examine the public docket for new material.
Larry W. Minor,

Associate Administrator for Policy.
DEPARTMENT OF TRANSPORTATION
Federal Railroad Administration
[Docket Number FRA-2010-0032]
Metro-North Railroad's Request To Amend Its Positive Train Control Safety Plan and Positive Train Control System

AGENCY:
Federal Railroad Administration (FRA), Department of Transportation (DOT).

ACTION:
Notice of availability and request for comments.

SUMMARY:
This document provides the public with notice that, on May 2, 2025, Metro-North Railroad (MNR) submitted a request for amendment (RFA) to its FRA-approved Positive Train Control Safety Plan (PTCSP) to update its onboard computer (OBC) software to OBC 02.00.0000 Software Baseline for the MNR Siemens Charger Dual Mode Locomotive. FRA is publishing this notice and inviting public comment on MNR's RFA to its PTCSP.

DATES:
FRA will consider comments received by June 2, 2025. FRA may consider comments received after that date to the extent practicable and without delaying implementation of valuable or necessary modifications to a PTC system.

ADDRESSES:
Comments: Comments may be submitted by going to https://www.regulations.gov and following the online instructions for submitting comments.
Instructions: All submissions must include the agency name and the applicable docket number. The relevant PTC docket number for this host railroad is Docket No. FRA-2010-0032. For convenience, all active PTC dockets are hyperlinked on FRA's website at https://railroads.dot.gov/research-development/program-areas/train-control/ptc/railroads-ptc-dockets. All comments received will be posted without change to https://www.regulations.gov; this includes any personal information.

FOR FURTHER INFORMATION CONTACT:
Gabe Neal, Staff Director, Signal, Train Control, and Crossings Division, telephone: 816-516-7168, email: Gabe.Neal@dot.gov.

SUPPLEMENTARY INFORMATION:
In general, title 49 United States Code (U.S.C.) section 20157(h) requires FRA to certify that a host railroad's PTC system complies with title 49 Code of Federal Regulations (CFR) part 236, subpart I, before the technology may be operated in revenue service. Before making certain changes to an FRA-certified PTC system or the associated FRA-approved PTCSP, a host railroad must submit, and obtain FRA's approval of, an RFA to its PTCSP under 49 CFR 236.1021.
Under 49 CFR 236.1021(e), FRA's regulations provide that FRA will publish a notice in the Federal Register and invite public comment in accordance with 49 CFR part 211, if an RFA includes a request for approval of a material modification of a signal or train control system. Accordingly, this notice informs the public that, on May 2, 2025, MNR submitted an RFA to its PTCSP for its Advanced Civil Speed Enforcement System II (ACSES-II), which seeks FRA's approval to update its OBC software to OBC 02.00.0000 Software Baseline for the MNR Siemens Charger Dual Mode Locomotive. That RFA is available in Docket No. FRA-2010-0032.
Interested parties are invited to comment on MNR's RFA to its PTCSP by submitting written comments or data. During FRA's review of MNR's RFA, FRA will consider any comments or data submitted within the timeline specified in this notice and to the extent practicable, without delaying implementation of valuable or necessary modifications to a PTC system. See 49 CFR 236.1021; see also 49 CFR 236.1011(e). Under 49 CFR 236.1021, FRA maintains the authority to approve, approve with conditions, or deny a railroad's RFA to its PTCSP at FRA's sole discretion.

Privacy Act Notice
In accordance with 49 CFR 211.3, FRA solicits comments from the public to better inform its decisions. DOT posts these comments, without edit, including any personal information the commenter provides, to https://www.regulations.gov, as described in the system of records notice (DOT/ALL-14 FDMS), which can be reviewed at https://www.transportation.gov/privacy. See https://www.regulations.gov/privacy-notice for the privacy notice of regulations.gov. To facilitate comment tracking, we encourage commenters to provide their name, or the name of their organization; however, submission of names is completely optional. If you wish to provide comments containing proprietary or confidential information, please contact FRA for alternate submission instructions.
Issued in Washington, DC.
Carolyn R. Hayward-Williams,

Director, Office of Railroad Systems and Technology.
DEPARTMENT OF TRANSPORTATION
Pipeline and Hazardous Materials Safety Administration
Hazardous Materials: Notice of Applications for New Special Permits

AGENCY:
Pipeline and Hazardous Materials Safety Administration (PHMSA), DOT.

ACTION:
List of applications for special permits.

SUMMARY:
In accordance with the procedures governing the application for, and the processing of, special permits from the Department of Transportation's Hazardous Material Regulations, notice is hereby given that the Office of Hazardous Materials Safety has received the application described herein.

DATES:
Comments must be received on or before June 11, 2025.

ADDRESSES:
Record Center, Pipeline and Hazardous Materials Safety Administration, U.S. Department of Transportation, Washington, DC 20590.
Comments should refer to the application number and be submitted in triplicate. If confirmation of receipt of comments is desired, include a self-addressed stamped postcard showing the special permit number.

FOR FURTHER INFORMATION CONTACT:
Donald Burger, Chief, Office of Hazardous Materials Safety General Approvals and Permits Branch, Pipeline and Hazardous Materials Safety Administration, U.S. Department of Transportation, East Building, PHH-13, 1200 New Jersey Avenue Southeast, Washington, DC 20590-0001, (202) 366-4535.

SUPPLEMENTARY INFORMATION:
Each mode of transportation for which a particular special permit is requested is indicated by a number in the “Nature of Application” portion of the table below as follows: (1) Motor vehicle, (2) Rail freight, (3) Cargo vessel, (4) Cargo aircraft only, (5) Passenger-carrying aircraft.
Copies of the applications are available for inspection in the Records Center, East Building, PHH-13, 1200 New Jersey Avenue Southeast, Washington DC.
This notice of receipt of applications for special permit is published in accordance with part 107 of the Federal hazardous materials transportation law (49 U.S.C. 5117(b); 49 CFR 1.53(b)).
Issued in Washington, DC, on May 1, 2025.
Donald P. Burger,

Chief, General Approvals and Permits Branch.
Special Permits Data
Application No. | Applicant | Regulation(s) affected | Nature of the special permits thereof
21982-N | Ford Motor Company | 173.185(b)(3)(ii), 173.185(b)(6) | To authorize the transportation of multiple large cells in large packaging in compliance with existing LP903 packing instruction of the UN Model Regulations. (modes 1, 2).
21983-N | Resonac America, Inc | 178.35 | To authorize the transportation in commerce of foreign cylinders containing Dichlorosilane. (modes 1, 3).
21985-N | Accuray Incorporated | 173.310 | To authorize the manufacture, mark, sale, and use of non-DOT specification cylinders for the purpose of incorporation into a radiation detector. (modes 1, 2, 3, 4, 5).
21988-N | PAG Holdings, LLC | 173.240(f), 178.1030 | To authorize the transportation in commerce of non-specification flexible intermediate bulk containers that do not conform to all applicable specification FIBC requirements in 49 CFR Part 178. (modes 1, 2).
| 21990-N | Gas Transport Leasing—GTL, LLC | 173.301(f)(1), 173.301(g)(1) | To authorize the transportation in commerce of compressed hydrogen in module assemblies containing non-DOT specification carbon fiber reinforced composite cylinders manufactured under DOT-SP 14576 without pressure relief devices. (mode 1).
21992-N | Tesla, Inc | 173.185(b) | To authorize the transportation in commerce by motor vehicle and rail freight of lithium cells packaged within a rigid plastic 50H Large Packaging. (modes 1, 2).
21996-N | ArkEdge Space Inc | 173.185(a)(1), 173.185(b)(3) | To authorize the transportation in commerce of prototype and low production lithium batteries via cargo-only aircraft in alternative packaging. (mode 4).
22000-N | Nouryon Functional Chemicals LLC | 172.203(a), 172.302(c), 173.31(d)(1)(ii) | To authorize the transportation in commerce of tank cars in which the manway cover gasket has been subjected to the leak detection method(s) in lieu of a visual inspection. (mode 2).
22001-N | Axxon Services, Inc | 172.400a(c) | To authorize the transportation in commerce of a refrigerant (R170) to a customer in another state within the US. (mode 1).
22002-N | United Brands Products Design Development and Marketing, Inc | 173.301(a)(11), 173.301b(c)(1), 178.71(d)(2) | To authorize the transportation in commerce of certain specification cylinders containing nitrous oxide that use an alternative valve standard. (mode 1).
22003-N | L3Harris Technologies, Inc | 173.302a(a)(1) | To authorize the transportation in commerce of non-DOT specification cylinders contained in spacecraft. (mode 1).
22005-N | Caterpillar Inc | 173.185(a)(1) | To authorize the transportation in commerce of prototype lithium batteries exceeding 35 kg via cargo-only aircraft. (mode 4).
22006-N | Plastipak Packaging, Inc | 178.33b-8(a)(1) | To authorize the transportation in commerce of DOT 2S plastic receptacles with a burst pressure of 300 psig or greater. (modes 1, 2, 3).
DEPARTMENT OF TRANSPORTATION
Pipeline and Hazardous Materials Safety Administration
Hazardous Materials: Notice of Applications for Modification to Special Permits

AGENCY:
Pipeline and Hazardous Materials Safety Administration (PHMSA), DOT.

ACTION:
List of applications for modification of special permits.

SUMMARY:
In accordance with the procedures governing the application for, and the processing of, special permits from the Department of Transportation's Hazardous Material Regulations, notice is hereby given that the Office of Hazardous Materials Safety has received the application described herein.

DATES:
Comments must be received on or before May 27, 2025.

ADDRESSES:
Record Center, Pipeline and Hazardous Materials Safety Administration, U.S. Department of Transportation, Washington, DC 20590.
Comments should refer to the application number and be submitted in triplicate. If confirmation of receipt of comments is desired, include a self-addressed stamped postcard showing the special permit number.

FOR FURTHER INFORMATION CONTACT:
Donald Burger, Chief, Office of Hazardous Materials Safety General Approvals and Permits Branch, Pipeline and Hazardous Materials Safety Administration, U.S. Department of Transportation, East Building, PHH-13, 1200 New Jersey Avenue Southeast, Washington, DC 20590-0001, (202) 366-4535.

SUPPLEMENTARY INFORMATION:
Each mode of transportation for which a particular special permit is requested is indicated by a number in the “Nature of Application” portion of the table below as follows: (1) Motor vehicle, (2) Rail freight, (3) Cargo vessel, (4) Cargo aircraft only, (5) Passenger-carrying aircraft.
Copies of the applications are available for inspection in the Records Center, East Building, PHH-13, 1200 New Jersey Avenue Southeast, Washington DC or at http://regulations.gov.
This notice of receipt of applications for special permit is published in accordance with part 107 of the Federal hazardous materials transportation law (49 U.S.C. 5117(b); 49 CFR 1.53(b)).
Issued in Washington, DC, on May 1, 2025.
Donald P. Burger,

Chief, General Approvals and Permits Branch.
Special Permits Data
Application No. | Applicant | Regulation(s) affected | Nature of the special permits thereof
10814-M | Spellman High Voltage Electronics Corporation | 173.302a | To modify the special permit to authorize an additional packaging. (modes 1,2, 3, 4, 5).
11379-M | ZF Passive Safety Systems US LLC | 173.302(a)(1), 173.301(a) | To modify the special permit to authorize additional packagings. (mode 1).
| 16133-M | Cryovat International BV (The Rootselaar Group) | 178.274(b) | To modify the special permit to decrease the minimum volume, increase the maximum volume, and increase the upper design pressure. (modes 1, 2, 3).
20279-M | Kaplan Industries, Inc | 180.207(d)(1) | To modify the special permit to authorize an additional cylinder. (modes 1, 2, 3, 4, 5).
20493-M | Tesla, Inc | 173.185(b)(5) | To modify the special permit to authorize an additional battery. (mode 4).
20646-M | Omni-Tanker PTY | 172.102(c)(3), 172.102(c)(7)(ii) | To modify the special permit to authorize additional lining materials within the cargo tank. (modes 1, 2).
21023-M | Tire Seal, Inc | 173.304(d) | To modify the special permit to authorize an additional hazardous material. (modes 1, 2, 3, 4, 5).
21213-M | Space Exploration Technologies Corp | 172.300, 172.400, 173.302(a), 172.402(f), 173.1, 177.840 | To modify the special permit to add the Starlink satellite designs which include an aluminum pressure vessel containing compressed gas as part of the propulsion system and a battery pack consisting of lithium-ion battery cells which would be transported over public highways. (mode 1).
21433-M | Pyrotek Special Effects Rock Lititz Inc | 173.306(k)(1)(iv)(A), 173.306(k)(1)(iv)(B) | To modify the special permit to add additional package closure options. (modes 1, 2, 3).
21528-M | Honeywell Intellectual Properties Inc | 173.302a(a)(1) | To modify the special permit to increase the service pressure to 10,400 psig from 10,000 psig. (mode 1).
21619-M | Decade Products, LLC | 173.185(f)(1), 173.185(f)(3) | To modify the special permit to authorize an additional packaging design. (modes 1, 2, 3).
21624-M | Porsche Logistik GmbH | 172.101(j) | To authorize a lithium battery with a higher net mass. (mode 4).
21664-M | Champion Container Corporation | 173.158(f)(3) | To modify the special permit to authorize additional concentrations of nitric acid. (modes 1, 2, 3).
21896-M | Caterpillar Inc | 172.101(j), 173.185(a)(1) | To modify the permit to reflect that the battery types have now been UN 38.3 tested and revise the special permit to only address the necessary authorization to exceed 35 kg via cargo-only aircraft. (mode 4).
DEPARTMENT OF TRANSPORTATION
Pipeline and Hazardous Materials Safety Administration
Hazardous Materials: Notice of Actions on Special Permits

AGENCY:
Pipeline and Hazardous Materials Safety Administration (PHMSA), DOT.

ACTION:
Notice of actions on special permit applications.

SUMMARY:
In accordance with the procedures governing the application for, and the processing of, special permits from the Department of Transportation's Hazardous Material Regulations, notice is hereby given that the Office of Hazardous Materials Safety has received the application described herein.

DATES:
Comments must be received on or before June 11, 2025.

ADDRESSES:
Record Center, Pipeline and Hazardous Materials Safety Administration, U.S. Department of Transportation, Washington, DC 20590.
Comments should refer to the application number and be submitted in triplicate. If confirmation of receipt of comments is desired, include a self-addressed stamped postcard showing the special permit number.

FOR FURTHER INFORMATION CONTACT:
Donald Burger, Chief, Office of Hazardous Materials Safety General Approvals and Permits Branch, Pipeline and Hazardous Materials Safety Administration, U.S. Department of Transportation, East Building, PHH-13, 1200 New Jersey Avenue Southeast, Washington, DC 20590-0001, (202) 366-4535.

SUPPLEMENTARY INFORMATION:
Copies of the applications are available for inspection in the Records Center, East Building, PHH-13, 1200 New Jersey Avenue Southeast, Washington, DC.
This notice of receipt of applications for special permit is published in accordance with part 107 of the Federal hazardous materials transportation law (49 U.S.C. 5117(b); 49 CFR 1.53(b)).
Issued in Washington, DC, on May 1, 2025.
Donald P. Burger,

Chief, General Approvals and Permits Branch.
Application No. | Applicant | Regulation(s) affected | Nature of the special permits thereof
Special Permits Data—Granted
970-M | Linde Gas & Equipment Inc | 173.302a(e), 180.205(h) | To modify the special permit to authorize DOT 3AL cylinders.
14318-M | Department of Defense US Army Military Surface Deployment & Distribution Command | 178.274(b), 178.275(a), 178.276(b)(1), 180.605(d) | To modify the special permit to authorize an additional stainless steel in the fabrication of the portable tank.
| 16011-M | Americase, LLC | 172.102(c)(1), 173.185(c), 173.185(f) | To modify the special permit to authorize end-of-life batteries and various battery chemistries within the same outer packaging.
20777-M | Israel Aerospace Industries Ltd | 172.101(j)(1), 173.302a(a)(1), 173.304a(a)(1), 173.56, 173.185(b) | To modify the special permit to authorize a different Net Explosive Weight and origin and destination locations.
21129-M | Northrop Grumman Systems Corp | 173.301, 173.302 | To update the special permit with changed part numbers.
21428-M | Livewire EV LLC | 172.101(j), 173.220(d), 173.185(a)(1) | To modify the special permit to authorize lithium ion batteries each with a net weight greater than 35 kg aboard cargo-only aircraft.
21470-M | Honeywell Intellectual Properties Inc | 173.302(a)(1), 180.205, 180.207, 180.209, 180.211, 180.212, 180.213, 180.215 | To modify the special permit to increase the maximum service pressure from 10,000 psig to 10,400 psig to factor in the unilateral pressure tolerance during fill.
21503-M | Samsung Austin Semiconductor, LLC | 171.23(a), 173.304(a)(1), 173.304(a)(2) | To modify the special permit to authorize use of DOT-3AL specification cylinders.
21751-N | New Pig Corporation | 172.600, 172.700(a), 172.400, 172.200, 172.300, 173.185(c)(1)(iii), 173.185(f) | To authorize the manufacture, mark, sale, and use of steel drums for the transportation in commerce of the lithium ion cells and batteries, including those contained in equipment or packed with equipment, identified in the special permit.
21764-N | NPROXX B.V | 173.302(a)(1) | To authorize the manufacture, mark, sale, and use of a non-DOT specification fully wrapped fiber reinforced composite gas cylinder with a non-load sharing plastic liner.
21859-N | Plastipak Packaging, Inc | 178.33b-5(a), 178.33b-6(a) | To authorize the manufacture, mark, sale, and use of non-DOT specification plastic non-refillable inside containers conforming with all regulations applicable to a DOT specification 2S plastic inside container, except that recycled plastic may be used, for the transportation in commerce of the hazardous materials in paragraph 6.
21870-N | Air Transport International, Inc | 172.101(j), 172.301(c), 172.400(a), 172.500(a), 173.27(b)(1) | To authorize the transportation in commerce of certain Division 4.3, cesium devices via passenger-carrying aircraft, which are typically forbidden for transportation aboard passenger-carrying aircraft.
21874-N | Kary Environmental Services, Inc | 173.185(f)(1), 173.185(f)(2), 173.185(f)(3) | To authorize the transportation in commerce of damaged, defective, and recalled lithium batteries in alternative packaging.
21880-N | U.S. Department of Energy | 173.202 | To authorize the transportation in commerce of non-DOT specification non-bulk packagings containing the hazardous materials specified in paragraph 6.
21887-N | Aerofil Technology, Inc | 173.306(a)(5)(v), 173.306(a)(5)(vi) | To authorize the transportation in commerce of non-flammable, non-toxic compressed gases (Division 2.2) in DOT Specification 2S and non-DOT specification plastic aerosols not exceeding 1L capacity designed and tested through an in-line pressure testing approach under a quality management system.
21892-N | Electronic Fluorocarbons, LLC | 173.304a(a), 173.301(f) | To authorize the transportation in commerce of anhydrous ammonia in DOT 3AAX cylinders.
21907-N | BMW Manufacturing Co., LLC | 173.185(b)(3)(i) | To authorize the transportation in commerce of lithium ion batteries in alternative packaging.
21909-N | Stericycle, Inc | 172.200 | To authorize the transportation in commerce of certain Division 6.2 materials without requiring shipping papers.
21910-N | AESC US, LLC | 173.185(b)(6) | To authorize the transportation in commerce by motor vehicle of lithium ion cells packaged within a rigid plastic UN 50H Large Packaging.
21921-N | O'Bryan Barrel Company, Inc | 172.203(a), 172.301(c), 178.601(e) | To authorize the transportation in commerce of UN 1A1 and UN 1A2 steel drums that are subject to alternative periodic retest requirements.
21933-N | Seattle Children's Hospital | 173.199, 173.199(a)(4) | To authorize the transportation in commerce of live rodents infected with a Category B infectious substance.
21935-N | Umoe Advanced Composites | 173.302(a)(1) | To authorize the manufacture, mark, sale, and use of a non-DOT specification fully wrapped fiber reinforced composite gas cylinder with a non-load sharing plastic liner.
| 21944-N | Korean Airlines Co., Ltd | 172.101(j), 175.30(a)(1) | To authorize the transportation in commerce of certain explosives that are forbidden for transportation aboard cargo-only aircraft or exceed the authorized quantity limits for cargo-only aircrafts as specified in the Hazardous Materials Table.
21980-N | U.S. Tank & Cryogenics Equipment, Inc | 172.203(a), 172.301(c), 180.211(c)(2)(i) | To authorize the repair of certain DOT 4L cylinders without requiring pressure testing.
21998-N | Airwest Helicopters, LLC | 172.101(j), 172.200, 172.301(c), 173.1, 175.75 | To authorize the transportation in commerce of certain hazardous materials only in remote areas of the U.S. by 14 CFR Part 133 cargo-only aircraft (rotorcraft external load operations) in which hazardous materials are attached to or suspended from the aircraft, and Part 135, as applicable, without being subject to certain hazard communication requirements, quantity limitations and certain loading and stowage requirements.
Special Permits Data—Denied
21560-N | Osram Sylvania Inc | 173.436 | To authorize the transportation in commerce of lamps containing Class 7 materials with activity limits exceeding those specified in 49 CFR 173.436, as excepted packages.
21843-N | DDP Specialty Electronic Materials US, LLC | 172.203(a), 172.301(c), 173.306(a)(3)(v)(A) | To authorize the transportation in commerce of DOT 2Q specification inner containers where the lot size for the alternative hot water bath test is increased to 10,000 cylinders.
21918-N | Autoliv ASP, Inc | 172.704 | To authorize the transportation in commerce of non-specification packaging containing airbag inflators or modules shipped by ground.
Special Permits Data—Withdrawn
21188-M | National Institutes of Health | 173.199 | To update point of contact and locations where the special permit will be used.
21831-N | Boyd Lancaster, Inc | 172.101(j), 172.101(j)(1), 173.301(f), 173.302a(a)(1), 173.304a(a)(2), 173.306(e) | To authorize the transportation in commerce of non-DOT specification containers (heat pipes) containing certain Class 2 materials for use in specialty cooling applications such as satellites and military aircraft.
21926-N | Greenhill Trading Inc | 172.315, 172.315(a), 172.315(c) | To incorporate the reduced-size limited quantity marking on shipping labels.
21953-N | Exolaunch, Inc | 172.300, 172.400, 173.301(g), 173.302(a) | To authorize the transportation by private vehicle of a cubesat satellite from the location of satellite fueling to the launch location.
21989-N | Hydro-Chem Systems, Inc | 173.13 | To authorize the transportation in commerce of 5-gallon DOT-specification packaging of UN2922 with alternative hazard communication.
21991-N | Air Resources Board | 173.301(g) | To authorize the transportation in commerce of one or more cylinders containing certain hazardous materials, where the cylinder valve is open, for the purpose of measuring brake particulate emissions.
DEPARTMENT OF THE TREASURY
Office of the Comptroller of the Currency
[Docket ID OCC-2025-0008]
Request for Information Regarding Community Bank Digitalization

AGENCY:
Office of the Comptroller of the Currency (OCC), Treasury.

ACTION:
Request for information and comment.

SUMMARY:
To build on its understanding, OCC is issuing a request for information (RFI) on community bank engagement with digitalization. The RFI solicits comment on the key challenges and barriers faced by community banks in the adoption and implementation of digital banking solutions.

DATES:
Comments must be received by June 26, 2025.

ADDRESSES:
Commenters are encouraged to submit comments through the Federal eRulemaking Portal. Please use the title “Request for Information Regarding Community Bank Digitalization” to facilitate the organization and distribution of the comments. You may submit comments by any of the following methods:
• Federal eRulemaking Portal—Regulations.gov: Go to https://regulations.gov/. Enter “Docket ID OCC-2025-0008” in the Search Box and click “Search.” Public comments can be submitted via the “Comment” box below the displayed document information or by clicking on the document title and then clicking the “Comment” box on the top-left side of the screen. For help with submitting effective comments, please click on “Commenter's Checklist.” For assistance with the Regulations.gov site, please call 1-866-498-2945 (toll free) Monday-Friday, 9 a.m.-5 p.m. Eastern time, or email regulationshelpdesk@gsa.gov.
• Mail: Chief Counsel's Office, Attention: Comment Processing, Office of the Comptroller of the Currency, 400 7th Street SW, Suite 3E-218, Washington, DC 20219.
• Hand Delivery/Courier: 400 7th Street SW, Suite 3E-218, Washington, DC 20219.
Instructions: You must include “OCC” as the agency name and “Docket ID OCC-2025-0008” in your comment. In general, the OCC will enter all comments received into the docket and publish the comments on the Regulations.gov website without change, including any business or personal information provided such as name and address information, email addresses, or phone numbers. Comments received, including attachments and other supporting materials, are part of the public record and subject to public disclosure. Do not include any information in your comment or supporting materials that you consider confidential or inappropriate for public disclosure.
You may review comments and other related materials that pertain to this action by the following method:
• Viewing Comments Electronically—Regulations.gov: Go to https://regulations.gov/. Enter “Docket ID OCC-2025-0008” in the Search Box and click “Search.” Click on the “Dockets” tab and then the document's title. After clicking the document's title, click the “Browse All Comments” tab. Comments can be viewed and filtered by clicking on the “Sort By” drop-down on the right side of the screen or the “Refine Comments Results” options on the left side of the screen. Supporting materials can be viewed by clicking on the “Browse Documents” tab. Click on the “Sort By” drop-down on the right side of the screen or the “Refine Results” options on the left side of the screen checking the “Supporting & Related Material” checkbox. For assistance with the Regulations.gov site, please call 1-866-498-2945 (toll free) Monday-Friday, 9 a.m.-5 p.m. ET, or email regulationshelpdesk@gsa.gov.
The docket may be viewed after the close of the comment period in the same manner as during the comment period.

FOR FURTHER INFORMATION CONTACT:
Gareth Henley, Financial Technology Policy Specialist, Bank Supervision Policy, (202) 649-5200. If you are deaf, hard of hearing, or have a speech disability, please dial 7-1-1 to access telecommunications relay services.

SUPPLEMENTARY INFORMATION:

I. Introduction
The OCC seeks public comment on community banks' engagement with digitalization. ^1 This RFI will supplement the OCC's understanding of these activities and support the OCC in its supervisory activities.
^1 The term “banks” as used in this RFI means national banks and Federal savings associations.

II. Community Bank Digitalization
The OCC supports the strengthening and modernization of community banks and aims to facilitate community banks' safe, sound, and fair transition to digital banking, including with regard to arrangements with technology providers and supporting a level playing field. In support of community banks' transition to digital solutions, the OCC recently published a non-exhaustive list of relevant OCC rules, statements, and guidance ^2 that community banks can reference.
^2 See Digitalization: Resources for Community Banks, OCC Bulletin 2025-3, (March 19, 2025).
For purposes of this RFI, digitalization is the use of technology to change a business model, provide new revenue and value-producing opportunities, or automate business processes. New and emerging technologies can be important tools for community banks to meet customer demand, increase revenue, improve efficiencies, and remain competitive. For example, digitalization can improve operational functions ( e.g., data analytics, transaction monitoring, process improvements, reporting, etc.), support the addition of new or expanded business lines, and allow banks to communicate more seamlessly with customers. In this way, digitalization has the potential to be a key component of community banking and institutions' ability to meet the future needs of the communities and customers they serve. When engaging in digitalization strategies and initiatives, the OCC examines banks for safety and soundness and compliance with applicable laws and regulations, including consumer protection laws. Banks are expected to implement risk management systems appropriate to the size of the institution and the nature, scope, and risk of its activities to identify, measure, monitor, and control risks for the strategies undertaken.
The OCC seeks input from community banks and relevant stakeholders regarding the key challenges and barriers faced in adopting and implementing digitalization strategies and initiatives. The purpose of this RFI is to better understand the specific obstacles that community banks encounter in their efforts to modernize operations, enhance customer experience, and remain competitive in an increasingly digital financial services environment. This request is separate from the “RFI on Bank-Fintech Arrangements Involving Banking Products and Services Distributed to Consumers and Businesses,” ^3 jointly issued by the OCC, Federal Reserve, and Federal Deposit Insurance Corporation in July 2024. The agencies continue to review and consider the feedback received on that document.
^3 89 FR 61577 (July 31, 2024).
We invite community banks, industry groups, technology providers, and other interested parties to respond to the following questions:
1. Planning for Digitalization: What are the primary challenges facing community banks in pursuing digitalization strategies or initiatives? To what extent is digitalization a strategic priority for community banks, and what factors influence this prioritization? How are community banks addressing the need to obtain subject matter expertise to make informed risk-based decisions about digitalization strategies, initiatives, or their implementation? What challenges, if any, are community banks facing in hiring or retaining qualified personnel ( e.g., information technology, cybersecurity, compliance, audit, and other assurance roles) to support digitalization strategies or initiatives?
2. Board and Governance: How are community banks' boards of directors engaged in overseeing and supporting digitalization strategies and initiatives? What challenges do community banks' boards of directors face when seeking education or considering opportunities regarding digitalization? How do community banks' boards balance the pursuit of a digitalization strategy with their overall risk appetite and the bank's long-term mission? Describe the governance processes or policies in place to ensure that community banks' digitalization strategies or initiatives align with their overall business strategy and regulatory obligations to operate in a safe and sound manner and in compliance with applicable laws and regulations.
3. Due Diligence and Implementation: What factors are affecting community banks' due diligence and pre-implementation research of digital solutions? What are the most common obstacles facing community bank digitalization during the due diligence and pre-implementation phase, and how are community banks overcoming them? What are the most common obstacles facing community bank digitalization during the implementation phase, and how are community banks overcoming them?
4. Digitalization Costs and Budget: A digitalization strategy can involve significant up-front and ongoing costs and resources. What types of up-front costs, ongoing costs, and resources are associated with undertaking a digitalization strategy? How are potential budget constraints impacting community banks' ability to adopt or maintain digitalization strategies?
5. Use of Third Parties: To what extent are community banks reliant on third parties ( e.g., core service providers, technology vendors, financial technology firms (fintechs), regulatory compliance solutions, etc.) for the implementation of digitalization strategies or initiatives? How is this reliance managed? Are there any impediments to community banks' digitalization strategies with respect to core service providers or other third parties? Are community banks able to address these impediments, and if so, how do they enhance their control environments to best manage third-party relationships in light of these impediments? Are community banks finding third-party solutions meet their specific digitalization needs? If not, where are community banks facing the biggest gaps? What is the range of practice for community banks working with a single third-party provider for an integrated approach to digitalization versus engaging multiple third-party providers to address specific needs? What are the benefits and challenges of each approach? How are banks managing the risk that a third party may introduce a new technology ( e.g., artificial intelligence (AI)) or process without the bank's prior knowledge, potentially increasing risk outside of the bank's risk appetite?
6. Competition and Market Trends: How do community banks see digitalization affecting their competitiveness with fintechs, larger banks, and similarly situated community banks? Describe any risks associated with the lack of digitalization strategies or initiatives. How do trends and customers' demands for digitalization impact community banks' digitalization strategies and initiatives? How do community banks gather feedback on customer demands and changing technology needs?
7. Use of Artificial Intelligence and Machine Learning: How are community banks incorporating AI and machine learning (ML) into their digitalization strategies and initiatives? How has this use evolved as new forms of AI become commercially available, such as generative AI? Are banks using AI primarily for cost savings and efficiency, revenue-generating activities, or other reasons? How are banks evolving their risk management to address the use of AI and ML, including when introduced through a third-party relationship? How can regulators support community banks' adoption of AI and ML?
8. Effect of Applicable Laws and Regulations: How do regulatory and compliance requirements impact the decision to undertake digitalization strategies or initiatives? What regulatory, compliance, or supervisory requirements present the greatest challenges to digitalization at community banks? How are banks using digitalization strategies and initiatives to increase the effectiveness or efficiency of compliance programs? How can regulators support community bank adaptation and competitiveness amid continued digitalization and technological evolution?
9. Associated Risks: How do community banks manage the ongoing risks of digitalization that may result in material financial risks? How do community banks and third-party providers, including fintechs, approach cybersecurity and data privacy concerns when considering the implementation of new technology at a community bank? How are community banks safeguarding against the evolving nature of threats arising from bad actors' use of new technology? How can regulators support community banks' adoption of new technologies and the management of associated risks?
10. Data Sharing: To what extent do community banks share data with third-party providers, including fintechs, as part of a digitalization strategy or initiative? What challenges or concerns are encountered in facilitating secure and compliant data sharing? How are community banks managing connectivity ( e.g., by using an application programming interface (API), secure file transfer protocol (SFTP), or some other method) for the secure sharing of data with third-party providers? Are there any limitations or constraints within community banks' API offerings, such as restrictions on functionality, data accessibility, scalability, or third-party compatibility? If so, what measures, frameworks, or technologies are community banks using to ensure seamless data exchange, interoperability, and secure communication across different platforms, core banking systems, and external fintechs?
Stuart Feldstein,

Acting Principal Deputy Chief Counsel, Office of the Comptroller of the Currency.
DEPARTMENT OF THE TREASURY
Office of Foreign Assets Control
Notice of OFAC Sanctions Action

AGENCY:
Office of Foreign Assets Control, Treasury.

ACTION:
Notice.

SUMMARY:
The U.S. Department of the Treasury's Office of Foreign Assets Control (OFAC) is publishing the names of one or more persons that have been placed on OFAC's Specially Designated Nationals and Blocked Persons List (SDN List) based on OFAC's determination that one or more applicable legal criteria were satisfied. All property and interests in property subject to U.S. jurisdiction of these persons are blocked, and U.S. persons are generally prohibited from engaging in transactions with them.

DATES:
This action was issued on April 29, 2025. See SUPPLEMENTARY INFORMATION for relevant dates.

FOR FURTHER INFORMATION CONTACT:
OFAC: Associate Director for Global Targeting, 202-622-2420; Assistant Director for Licensing, 202-622-2480; Assistant Director for Sanctions Compliance, 202-622-2490 or https://ofac.treasury.gov/contact-ofac.

SUPPLEMENTARY INFORMATION:

Electronic Availability
The SDN List and additional information concerning OFAC sanctions programs are available on OFAC's website: https://ofac.treasury.gov.

Notice of OFAC Action
On April 29, 2025, OFAC determined that the property and interests in property subject to U.S. jurisdiction of the following persons are blocked under the relevant sanctions authority listed below.

Individuals
1. ASGARI, Mohammad, Iran; DOB 03 Jul 1979; nationality Iran; Additional Sanctions Information—Subject to Secondary Sanctions; Gender Male; National ID No. 1289040249 (Iran) (individual) [NPWMD] [IFSR] (Linked To: ISLAMIC REVOLUTIONARY GUARD CORPS).
Designated pursuant to section 1(a)(iii) of Executive Order 13382 of June 28, 2005, “Blocking Property of Weapons of Mass Destruction Proliferators and Their Supporters,” 70 FR 38567, 3 CFR, 2005 Comp., p. 170 (E.O. 13382), for having provided, or attempted to provide, financial, material, technological or other support for, or goods or services in support of, ISLAMIC REVOLUTIONARY GUARD CORPS, a person whose property and interests in property are blocked pursuant to E.O. 13382.
2. MODARRES FATHI, Forough (a.k.a. MODARES FATHI, Forough; a.k.a. MODARRES FATHI, Forugh), Isfahan, Iran; DOB 29 Aug 1950; nationality Iran; Additional Sanctions Information—Subject to Secondary Sanctions; Gender Female; Passport I62009245 (Iran) expires 29 Feb 2028; National ID No. 1286411351 (Iran) (individual) [NPWMD] [IFSR] (Linked To: SAMAN TEJARAT BARMAN TRADING COMPANY).
Designated pursuant to section 1(a)(iii) of E.O. 13382 for having provided, or attempted to provide, financial, material, technological or other support for, or goods or services in support of, SAMAN TEJARAT BARMAN TRADING COMPANY, a person whose property and interests in property are blocked pursuant to E.O. 13382.
3. POUR KAZEMI, Abbas (a.k.a. PORKAZEMI, Abbas; a.k.a. PURKAZEMI, Abbas), Isfahan, Iran; DOB 06 Nov 1952; nationality Iran; Additional Sanctions Information—Subject to Secondary Sanctions; Gender Male; National ID No. 1285448774 (Iran) (individual) [NPWMD] [IFSR] (Linked To: SAMAN TEJARAT BARMAN TRADING COMPANY).
Designated pursuant to section 1(a)(iii) of E.O. 13382 for having provided, or attempted to provide, financial, material, technological or other support for, or goods or services in support of, SAMAN TEJARAT BARMAN TRADING COMPANY, a person whose property and interests in property are blocked pursuant to E.O. 13382.
4. ZARGAR BAB ALDASHTI, Abed (a.k.a. ZARGAR BAB ALDASHTI, Abid; a.k.a. ZARGARBABODDASHTI, Abed), Isfahan, Iran; DOB 05 Jul 1978; nationality Iran; Additional Sanctions Information—Subject to Secondary Sanctions; Gender Male; National ID No. 0069233888 (Iran) (individual) [NPWMD] [IFSR] (Linked To: SAMAN TEJARAT BARMAN TRADING COMPANY).
Designated pursuant to section 1(a)(iv) of E.O. 13382 for acting or purporting to act for or on behalf of, directly or indirectly, SAMAN TEJARAT BARMAN TRADING COMPANY, a person whose property and interests in property are blocked pursuant to E.O. 13382.
5. ZARGAR BAB ALDASHTI, Hamed (a.k.a. ZARGARBABODDASHTI, Hamed; a.k.a. ZARGARBABOLDASHTI, Hamed), Isfahan, Iran; Dubai, United Arab Emirates; DOB 27 Apr 1977; nationality Iran; alt. nationality United Arab Emirates; Additional Sanctions Information—Subject to Secondary Sanctions; Gender Male; Passport U97775345 (United Arab Emirates) expires 11 Sep 2029; National ID No. 0069074771 (Iran) (individual) [NPWMD] [IFSR] (Linked To: SAMAN TEJARAT BARMAN TRADING COMPANY).
Designated pursuant to section 1(a)(iv) of E.O. 13382 for acting or purporting to act for or on behalf of, directly or indirectly, SAMAN TEJARAT BARMAN TRADING COMPANY, a person whose property and interests in property are blocked pursuant to E.O. 13382.
6. ZARGAR BAB ALDASHTI, Zahra (a.k.a. ZARGAR BABODDASHTI, Zahra), Isfahan, Iran; DOB 28 Jul 2003; nationality Iran; Additional Sanctions Information—Subject to Secondary Sanctions; Gender Female; National ID No. 1274057711 (Iran) (individual) [NPWMD] [IFSR] (Linked To: SAMAN TEJARAT BARMAN TRADING COMPANY).
Designated pursuant to section 1(a)(iv) of E.O. 13382 for acting or purporting to act for or on behalf of, directly or indirectly, SAMAN TEJARAT BARMAN TRADING COMPANY, a person whose property and interests in property are blocked pursuant to E.O. 13382.

Entities
1. CHINA CHLORATE TECH CO LIMITED, Chuanxing Town, Yanling County, Zhuzhou, Hunan, China; Hong Kong, China; Additional Sanctions Information—Subject to Secondary Sanctions; Organization Established Date 17 May 2022; Company Number 3153395 (Hong Kong); Business Registration Number 74050495 (Hong Kong) [NPWMD] [IFSR] (Linked To: YANLING CHUANXING CHEMICAL PLANT GENERAL PARTNERSHIP).
Designated pursuant to section 1(a)(iii) of E.O. 13382 for having provided, or attempted to provide, financial, material, technological or other support for, or goods or services in support of, YANLING CHUANXING CHEMICAL PLANT GENERAL PARTNERSHIP, a person whose property and interests in property are blocked pursuant to E.O. 13382.
2. DONGYING WEIAIEN CHEMICAL CO LTD, Shandong 257300, China; Additional Sanctions Information—Subject to Secondary Sanctions; Organization Established Date 13 Oct 2014; Registration Number 370523200027679 (China); Unified Social Credit Code (USCC) 913705233129553678 (China) [NPWMD] [IFSR] (Linked To: SAMAN TEJARAT BARMAN TRADING COMPANY).
Designated pursuant to section 1(a)(iii) of E.O. 13382 for having provided, or attempted to provide, financial, material, technological or other support for, or goods or services in support of, SAMAN TEJARAT BARMAN TRADING COMPANY, a person whose property and interests in property are blocked pursuant to E.O. 13382.
3. SAMAN TEJARAT BARMAN TRADING COMPANY, Number 226, South Unit, Floor 1, Abdul Razzaq Street, Mikhak Alley, Naqsh-e Jahan, Central District, Isfahan County, Isfahan City, Isfahan Province 8147846492, Iran; Additional Sanctions Information—Subject to Secondary Sanctions; Organization Established Date 08 Apr 2018; National ID No. 14007515283 (Iran); Registration Number 60254 (Iran) [NPWMD] [IFSR] (Linked To: ISLAMIC REVOLUTIONARY GUARD CORPS).
Designated pursuant to section 1(a)(iii) of E.O. 13382 for having provided, or attempted to provide, financial, material, technological or other support for, or goods or services in support of, ISLAMIC REVOLUTIONARY GUARD CORPS, a person whose property and interests in property are blocked pursuant to E.O. 13382.
4. SHENZHEN AMOR LOGISTICS CO LTD (a.k.a. SHENZHEN AIMI INTERNATIONAL LOGISTICS CO LTD), Unit 806, Huafeng Building, No. 6006 Shennan Avenue, Futian District, Shenzhen, Guangdong, China; website amorlogis.com; Additional Sanctions Information—Subject to Secondary Sanctions; Organization Established Date 20 Jun 2017; Registration Number 440300201508973 (China); Unified Social Credit Code (USCC) 91440300MA5EKR079F (China) [NPWMD] [IFSR] (Linked To: ISLAMIC REVOLUTIONARY GUARD CORPS).
Designated pursuant to section 1(a)(iii) of E.O. 13382 for having provided, or attempted to provide, financial, material, technological or other support for, or goods or services in support of, ISLAMIC REVOLUTIONARY GUARD CORPS, a person whose property and interests in property are blocked pursuant to E.O. 13382.
5. YANLING CHUANXING CHEMICAL PLANT GENERAL PARTNERSHIP (a.k.a. YANLING COUNTY CHUANXING CHEMICAL PLANT GENERAL PARTNERSHIP; a.k.a. YANLING COUNTY SHIP SHAPED CHEMICAL PLANT GENERAL PARTNERSHIP), Chuanxing Town, Yanling County, Zhuzhou, Hunan, China; Additional Sanctions Information—Subject to Secondary Sanctions; Organization Established Date 10 Jun 2008; Registration Number 430225600023395 (China); Unified Social Credit Code (USCC) 91430225L26191645X (China) [NPWMD] [IFSR] (Linked To: SHENZHEN AMOR LOGISTICS CO LTD).
Designated pursuant to section 1(a)(iii) of E.O. 13382 for having provided, or attempted to provide, financial, material, technological or other support for, or goods or services in support of, SHENZHEN AMOR LOGISTICS CO LTD, a person whose property and interests in property are blocked pursuant to E.O. 13382.
6. YANLING LINGFENG CHLORATE CO LTD (a.k.a. YANLING COUNTY LINGFENG CHEMICAL TRADING CO LTD), 1 Chuangye Road, Entrepreneurship Park, Xiayang Town, Yanling County, Zhuzhou, Hunan, China; Additional Sanctions Information—Subject to Secondary Sanctions; Organization Established Date 15 Dec 2021; Unified Social Credit Code (USCC) 91430225MA7DEW2U3K (China) [NPWMD] [IFSR] (Linked To: CHINA CHLORATE TECH CO LIMITED).
Designated pursuant to section 1(a)(iii) of E.O. 13382 for having provided, or attempted to provide, financial, material, technological or other support for, or goods or services in support of, CHINA CHLORATE TECH CO LIMITED, a person whose property and interests in property are blocked pursuant to E.O. 13382.
Lisa M. Palluconi,

Acting Director, Office of Foreign Assets Control.
DEPARTMENT OF THE TREASURY
Internal Revenue Service
Proposed Extension of Information Collection Request Submitted for Public Comment; Comment Request on Burden Related to Contributions for Aid of Construction Under Section 118(c)

AGENCY:
Internal Revenue Service (IRS), Treasury.

ACTION:
Notice and request for comments.

SUMMARY:
The Internal Revenue Service, as part of its continuing effort to reduce paperwork and respondent burden, invites the public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. Currently, the IRS is soliciting comments concerning the burden related to contributions for aid of construction under section 118(c).

DATES:
Written comments should be received on or before July 11, 2025 to be assured of consideration.

ADDRESSES:
Written comments and recommendations for the proposed information collection should be sent within 60 days of publication of this notice to pra.comments@irs.gov. Please include, “OMB Number: 1545-1639—Public Comment Request Notice” in the Subject line. Requests for additional information or copies of this collection can be directed to Ronald J. Durbala, at RJoseph.Durbala@irs.gov.

SUPPLEMENTARY INFORMATION:
Title: Aid of Construction Under Section 118(c).
OMB Number: 1545-1639.
Project Number: TD 8936.
Abstract: This regulation provides guidance with respect to section 118(c), which provides that a contribution in aid of construction received by a regulated public water or sewage utility is treated as a contribution to the capital of the utility and excluded from gross income.
Current Actions: There is no change to the existing collection.
Type of Review: Extension of a currently approved collection.
Affected Public: Businesses and other for-profit organizations.
Estimated Number of Respondents: 300.
Estimated Time per Respondent: 60 min.
Estimated Total Annual Burden Hours: 300.
The following paragraph applies to all the collections of information covered by this notice:
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless the collection of information displays a valid OMB control number.
Books or records relating to a collection of information must be retained if their contents may become material in the administration of any internal revenue law. Generally, tax returns and tax return information are confidential, as required by 26 U.S.C. 6103.
Desired Focus of Comments: The Internal Revenue Service (IRS) is particularly interested in comments that:
• Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility.
• Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used.
• Enhance the quality, utility, and clarity of the information to be collected; and
• Minimize the burden of the collection of information on those who are to respond, including using appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., by permitting electronic submissions of responses.
Comments submitted in response to this notice will be summarized and/or included in the ICR for OMB approval of the extension of the information collection; they will also become a matter of public record.
Approved: May 6, 2025.
Ronald J. Durbala,

IRS Tax Analyst.
DEPARTMENT OF VETERANS AFFAIRS
[OMB Control No. 2900-0043]
Agency Information Collection Activity: Application Request To Add and/or Remove Dependents

AGENCY:
Veterans Benefits Administration, Department of Veterans Affairs.

ACTION:
Notice.

SUMMARY:
Veterans Benefits Administration (VBA), Department of Veterans Affairs (VA), is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act (PRA) of 1995, Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed revision of a currently approved collection, and allow 60 days for public comment in response to the notice.

DATES:
Comments must be received on or before July 11, 2025.

ADDRESSES:
Comments must be submitted through www.regulations.gov .

FOR FURTHER INFORMATION CONTACT:
Program-Specific information: Nancy Kessinger, 202-632-8924, nancy.kessinger@va.gov.
VA PRA information: Dorothy Glasgow, 202-461-1084, VAPRA@va.gov.

SUPPLEMENTARY INFORMATION:
Under the PRA of 1995, Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. This request for comment is being made pursuant to Section 3506(c)(2)(A) of the PRA.
With respect to the following collection of information, VBA invites comments on: (1) whether the proposed collection of information is necessary for the proper performance of VBA's functions, including whether the information will have practical utility; (2) the accuracy of VBA's estimate of the burden of the proposed collection of information; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or the use of other forms of information technology.
Title: Application Request to Add and/or Remove Dependents (VA Form 21-686c).
OMB Control Number: 2900-0043. https://www.reginfo.gov/public/do/PRASearch.
Type of Review: Revision of a currently approved collection.
Abstract: VA Form 21-686c is used to gather the necessary information to determine eligibility for additional benefits for dependents. Without this information, entitlement to these benefits could not be determined.
No changes have been made to this form. The estimated annual burden has increased due to the increase in the estimated number of respondents, which is based on the increase in the number of submissions of this collection since the last renewal for this collection.
Affected Public: Individuals or Households.
Estimated Annual Burden: 267,769 hours.
Estimated Average Burden per Respondent: 30 minutes.
Frequency of Response: One time.
Estimated Number of Respondents: 535,538 per year.
Authority: 44 U.S.C. 3501 et seq.
Shunda Willis,

Acting, VA PRA Clearance Officer, (Alt.), Office of Enterprise and Integration/Data Governance Analytics, Department of Veterans Affairs.
90
90
Monday, May 12, 2025
Rules and Regulations
Part II
Office of Management and Budget
Office of Federal Procurement Policy
Department of Defense
General Services Administration
National Aeronautics and Space Administration
48 CFR Chapter 1

Federal Acquisition Regulations; Federal Acquisition Circular 2025-04; Introduction; List of Domestically Nonavailable Articles; Technical Amendments; and Federal Acquisition Circular 2025-04; Small Entity Compliance Guide; Rules
OFFICE OF MANAGEMENT AND BUDGET
Office of Federal Procurement Policy
DEPARTMENT OF DEFENSE
GENERAL SERVICES ADMINISTRATION
NATIONAL AERONAUTICS AND SPACE ADMINISTRATION
48 CFR Chapter 1
[Docket No. FAR-2025-0051, Sequence No. 1]
Federal Acquisition Regulation; Federal Acquisition Circular 2025-04; Introduction

AGENCY:
Office of Federal Procurement Policy (OFPP), Office of Management and Budget; Department of Defense (DoD); General Services Administration (GSA); and National Aeronautics and Space Administration (NASA).

ACTION:
Summary presentation of final rules.

SUMMARY:
This document summarizes the Federal Acquisition Regulation (FAR) rules agreed to by OFPP, DoD, GSA, and NASA (collectively referred to as the Federal Acquisition Regulatory Council) in this Federal Acquisition Circular (FAC) 2025-04. A companion document, the Small Entity Compliance Guide (SECG), follows this FAC.

DATES:
For effective dates see the separate documents, which follow.

ADDRESSES:
The FAC, including the SECG, is available at https://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT:
For clarification in relation to the FAR cases listed in the table below, contact FARPolicy@gsa.gov or call 202-969-4075. For information pertaining to status or publication schedules, contact the Regulatory Secretariat Division at 202-501-4755 or GSARegSec@gsa.gov.
Rules Listed in FAC 2025-04
Item | Subject | FAR case
I | List of Domestically Nonavailable Articles | 2020-009
II | Technical Amendments |

SUPPLEMENTARY INFORMATION:
Summaries for each FAR rule follow. For the actual revisions and/or amendments made by these FAR rules, refer to the specific item numbers and subjects set forth in the documents following these item summaries. FAC 2025-04 amends the FAR as follows:

Item I—List of Domestically Nonavailable Articles (FAR Case 2020-009)
This final rule amends the FAR to revise the list of domestically nonavailable articles under the Buy American statute. The changes are not expected to have a significant economic impact on a substantial number of small entities. It is expected that this rule will encourage small businesses to take an interest in building domestic manufacturing capabilities and capacity; this would be a positive impact though not a substantial impact.

Item II—Technical Amendments
Administrative changes are made at FAR 1.401, 17.703, 33.105, 52.101, 52.102, 52.300, 52.301.
William F. Clark,

Director, Office of Government-wide Acquisition Policy, Office of Acquisition Policy, Office of Government-wide Policy.
Federal Acquisition Circular (FAC) 2025-04 is issued under the authority of the Administrator for Federal Procurement Policy, the Secretary of Defense, the Administrator of General Services, and the Administrator of National Aeronautics and Space Administration.
Unless otherwise specified, all Federal Acquisition Regulation (FAR) and other directive material contained in FAC 2025-04 is effective May 12, 2025 except for Items I and II, which are effective June 11, 2025.
Mathew Blum,

Acting Administrator for Federal Procurement Policy Office of Management and Budget.
John M. Tenaglia,

Principal Director, Defense Pricing, Contracting, and Acquisition Policy, Department of Defense.
Jeffrey A. Koses,

Senior Procurement Executive/Deputy CAO, Office of Acquisition Policy, U.S. General Services Administration.
Karla Smith Jackson,

Assistant Administrator for Procurement, Senior Procurement Executive/Deputy CAO, National Aeronautics and Space Administration.
OFFICE OF MANAGEMENT AND BUDGET
Office of Federal Procurement Policy
DEPARTMENT OF DEFENSE
GENERAL SERVICES ADMINISTRATION
DEPARTMENT OF ENERGY
NATIONAL AERONAUTICS AND SPACE ADMINISTRATION
48 CFR Part 25
[FAC 2025-04, FAR Case 2020-009, Item I; Docket No. FAR-2020-0009, Sequence No. 1]
RIN 9000-AO07
Federal Acquisition Regulation: List of Domestically Nonavailable Articles

AGENCY:
Office of Federal Procurement Policy (OFPP), Office of Management and Budget; Department of Defense (DoD); General Services Administration (GSA); and National Aeronautics and Space Administration (NASA).

ACTION:
Final rule.

SUMMARY:
OFPP, DoD, GSA, and NASA (collectively referred to as the Federal Acquisition Regulatory Council) are issuing a final rule amending the Federal Acquisition Regulation (FAR) to revise the list of domestically nonavailable articles under the Buy American statute.

DATES:
Effective June 11, 2025.

FOR FURTHER INFORMATION CONTACT:
For clarification of content, contact FARPolicy@gsa.gov or call 202-969-4075. For information pertaining to status or publication schedules contact the Regulatory Secretariat Division at 202-501-4755 or GSARegSec@gsa.gov. Please cite FAC 2025-04, FAR Case 2020-009.

SUPPLEMENTARY INFORMATION:

I. Background
DoD, GSA, and NASA published a proposed rule at 89 FR 84505 on October 23, 2024, to revise the list of domestically nonavailable articles at FAR 25.104(a) and implement requirements related to making future changes to the list consistent with section 9 of Executive Order (E.O.) 14005, Ensuring the Future Is Made in All of America by All of America's Workers (86 FR 7475, January 28, 2021). The removal of articles from the list at FAR 25.104(a) supports the Administration's America First Trade Policy, by encouraging a more dynamic, secure, and competitive domestic industrial base.
As published in the proposed rule, this final rule removes the following articles from the list at FAR 25.104(a): acetylene, black; agar, bulk; anise; asbestos, amosite, chrysotile, and crocidolite; bauxite; beef, corned, canned; beef extract; bephenium hydroxynaphthoate; cadmium, ores and flue dust; calcium cyanamide; castor beans and castor oil; chalk, English; chicle; cinchona bark; cobalt, in cathodes, rondelles, or other primary ore and metal forms; colchicine alkaloid, raw; copra; crane rail (85-pound per foot); cryolite, natural; dammar gum; diamonds, industrial, stones and abrasives; emetine, bulk; ergot, crude; erythrityl tetranitrate; goat hair canvas; goat and kidskins; graphite, natural, crystalline, crucible grade; hand file sets (Swiss pattern); handsewing needles; ipecac, root; iodine, crude; kaurigum; lac; lavender oil; leather, sheepskin, hair type; manganese; menthol, natural bulk; mica; microprocessor chips (brought onto a Government construction site as separate units for incorporation into building systems during construction or repair and alteration of real property); nickel, primary, in ingots, pigs, shots, cathodes, or similar forms; nickel oxide and nickel salts; nux vomica, crude; oiticica oil; olive oil; olives (green), pitted or unpitted, or stuffed, in bulk; opium, crude; petroleum, crude oil, unfinished oils, and finished products; pine needle oil; platinum and related group metals, refined, as sponge, powder, ingots, or cast bars; pyrethrum flowers; quebracho; quinidine; quinine; rabbit fur felt; radium salts, source and special nuclear materials; rosettes; santonin, crude; secretin; shellac; sugars, raw; talc, block, steatite; tantalum; thread, metallic (gold); thyme oil; triprolidine hydrochloride; tungsten; wax, carnauba; wire glass; woods, logs, veneer, and lumber of the following species: Alaskan yellow cedar, angelique, balsa, ekki, greenheart, lignum vitae, mahogany, and teak; yarn, 50 Denier rayon; and yeast, active dry and instant active dry.
For further details please see the proposed rule. Thirteen respondents submitted comments on the proposed rule.

II. Discussion and Analysis
The Civilian Agency Acquisition Council and the Defense Acquisition Regulations Council (the Councils) reviewed the public comments in the development of the final rule. A discussion of the comments is provided as follows:

A. Summary of Significant Changes
The proposed paragraph (b) at FAR 25.104 has been removed from the final rule. While the Federal Acquisition Regulatory Council intends to follow the procedures proposed at paragraph (b), these procedures are not required to be included in the FAR. The procedures include an economic analysis of relevant markets and available market research to be performed by the Director of the Office of Management and Budget (OMB), through the Administrator of the Office of Federal Procurement Policy, in consultation with the Secretary of Commerce and the Director of OMB's Made in America Office (MIAO), prior to any changes to the list at FAR 25.104(a).

B. Analysis of Public Comments
1. Support removal of certain articles from the list at FAR 25.104(a).
Comment: Some respondents expressed their support in removing the following articles from the list: manganese; olives (green), pitted or unpitted, or stuffed, in bulk; and tungsten. A respondent stated, “This change is a pivotal move toward fostering long-term market stability and enhancing supply chain resilience.” Some respondents expressed that the rule will “strengthen collaboration between Government agencies and industry stakeholders”.
Response: The respondents' input is appreciated.
2. Oppose removal of certain articles from the list at FAR 25.104(a).
Comment: Some respondents recommended revising the proposed rule to retain nitrile butadiene rubber (“NBR”) on the list at FAR 25.104(a). They considered removal would be premature due to limited domestic capacity that is unable to meet the Government demand. Others contended that retention on the list will ensure the availability of personal protective equipment, specifically nitrile gloves.
Further, some respondents recommended retaining “yarn, 50 Denier rayon” on the list because of limited or non-existent domestic availability. The respondents stated that removing yarn from the list creates a conflict or inconsistency with the Berry Amendment (10 U.S.C. 4862), and although the Buy American Act and the Berry Amendment “represent different procurement models,” application of the two statutes “should be premised on the same fact patterns”.
Response: The policy reasons articulated in the preamble to the proposed rule remain valid, although the respondents' comments are acknowledged. The rule is intended to be a general reset of the list, which is updated every 5 years. Agencies may provide relevant information during forthcoming reviews of the list at FAR 25.104(a).
The rule's change of “Rubber, crude and latex” to “Rubber, crude and latex (natural)” clarifies that synthetic rubber is excluded from the list. Accordingly, using individualized waivers, which are coordinated centrally and posted for public awareness, should encourage the type of ongoing, proactive engagement with industry that is vital to allowing the Government to understand supply chains and market trends, strengthening domestic manufacturing, and reducing the need for regulatory waivers over time. Agencies have already begun utilizing the individual waiver process for nitrile gloves and this process has not prevented the acquisition of nitrile gloves, and other personal protective equipment, to meet agency needs.
Regarding an apparent conflict with the Berry Amendment, the Buy American statute and the Berry Amendment are two separate laws implemented by two different regulations. They differ regarding their scope, threshold, exceptions, and waiver authority.
3. Support and opposition to removal of certain articles from the list at FAR 25.104(a).
Comment: Some respondents provided arguments for removing, and another respondent provided similar arguments for retaining, the following articles from the list: cobalt, in cathodes, rondelles, or other primary ore and metal forms; nickel, primary, in ingots, pigs, shots, cathodes, or similar forms, nickel oxide and nickel salts; and tantalum.
Response: As explained in the proposed rule, there is no substantial evidence that there is a major increase in the availability of the articles being removed. The respondents highlighted the critical nature of these articles. The Government expects that more limited duration waivers with centralized management would provide important insight into Government supply chains, including critical supply chains with national or economic security implications. Agencies may pursue multi-procurement waivers for repetitive needs where market research indicates that domestic capability may be lacking for a period, provided the waiver is time limited. FAR 25.103(b)(1)(ii) already requires that “before acquisition of an article on the list, the procuring agency is responsible to conduct market research appropriate to the circumstances, including seeking of domestic sources.” This rule encourages further market research and a proactive engagement with industry to understand supply chains and market trends vital to strengthening domestic manufacturing.

III. Applicability to Contracts at or Below the Simplified Acquisition Threshold (SAT) and for Commercial Products (Including Commercially Available Off-the-Shelf (COTS) Items) or for Commercial Services
This rule does not create new solicitation provisions or contract clauses or impact any existing provisions or clauses.

IV. Expected Impact of the Rule
The final rule reduces the number of articles on the list at FAR 25.104(a) that are presumed by regulation to be nonavailable in the United States in sufficient and reasonably available commercial quantities and of a satisfactory quality. Over time, decreased reliance on regulatory waivers and greater use of individual waivers that are reviewed centrally and posted publicly should contribute to a more dynamic, secure, and competitive domestic industrial base. There are a number of strategic advantages to central review and posting of waivers, including: the ability for MIAO and agencies to share market research information and insight that might lead to the identification of domestic sources in future acquisitions; the ability for agencies to send a clear demand signal to industry of the Federal Government's desire to reduce reliance on foreign-made items; the ability for potential sources to see opportunities for new domestic providers, and for existing domestic providers that may have been overlooked to see if agencies may have missed market capabilities in their market research; and the opportunity for MIAO to bring greater consistency in use of waivers across the Government through its feedback to agencies. The heightened transparency provided on individual waivers can be especially beneficial in furthering contractor resilience by reducing transaction costs for potential sellers, which encourages new entrants by lowering a barrier to entry for businesses into the Federal market. These benefits of the individual waivers align with the America First Trade Policy which puts the American economy, the American worker, and American national security first.
The final rule provides these benefits at minimal cost to Federal contractors or the Government. There should be no cost to Federal contractors from the reduction of articles on the regulatory waiver list, as the transition to individual waivers should increase transparency and reduce transactions costs associated with finding domestic opportunities. The rule is expected to create only minimal additional procurement costs to the Government due to the low amount of spend and the low number of contract actions for the articles removed from the list.

V. Executive Orders 12866, 13563, and 14192
Executive Order (E.O.) 12866, Regulatory Planning and Review, dated September 30, 1993, directs agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). E.O. 13563, Improving Regulation and Regulatory Review, dated January 18, 2011, emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This rule is a significant regulatory action under E.O. 12866 and, therefore, was subject to review under section 6(b) of E.O. 12866.
This rule is not subject to E.O. 14192, Unleashing Prosperity Through Deregulation, because this rule has a de minimis impact on the public. See discussion in the
“Expected Impact of the Rule” section of this preamble.

VI. Congressional Review Act
Pursuant to the Congressional Review Act, the FAR Council will send this rule to each House of the Congress and to the Comptroller General of the United States. The Office of Information and Regulatory Affairs (OIRA) in the Office of Management and Budget has determined that this rule does not meet the definition in 5 U.S.C. 804(2).

VII. Regulatory Flexibility Act
The Federal Acquisition Regulatory Council has prepared a Final Regulatory Flexibility Analysis (FRFA) consistent with the Regulatory Flexibility Act, 5 U.S.C. 601-612.
1. Statement of the need for, and the objectives of, the rule. The objective of this rule is to revise the list of domestically nonavailable articles under the Buy American statute at FAR 25.104(a).
2. Statement of the significant issues raised by the public comments in response to the initial regulatory flexibility analysis, a statement of the assessment of the agency of such issues, and a statement of any changes made to the rules as a result of such comments. There were no significant issues raised by the public in response to the initial regulatory flexibility analysis.
3. Description of and an estimate of the number of small entities to which the rule will apply. The rule impacts all entities that do business with the Federal Government, including the over 405,972 small business registrants in the System for Award Management. However, the Federal Acquisition Regulatory Council does not expect this rule to have a significant economic impact on a substantial number of small entities because the rule is not implementing any requirements with which small entities must comply. It is expected that this rule will encourage small businesses to take an interest in building domestic manufacturing capabilities and capacity; this would be a positive impact though not a substantial impact.
4. Description of projected reporting, recordkeeping, and other compliance requirements of the rule. The rule does not include additional, or change any existing, reporting or recordkeeping requirements.
5. Description of the steps the agency has taken to minimize the significant economic impact on small entities consistent with the stated objectives of applicable statutes.
There are no available alternatives to the rule to accomplish the desired objective.
Interested parties may obtain a copy of the FRFA from the Regulatory Secretariat Division. The Regulatory Secretariat Division has submitted a copy of the FRFA to the Chief Counsel for Advocacy of the Small Business Administration.

VIII. Paperwork Reduction Act
This rule does not contain any information collection requirements that require the approval of the Office of Management and Budget under the Paperwork Reduction Act (44 U.S.C. 3501-3521).

List of Subjects in 48 CFR Part 25
Government procurement.
William F. Clark,

Director, Office of Government-wide Acquisition Policy, Office of Acquisition Policy, Office of Government-wide Policy.
Therefore, OFPP, DoD, GSA, and NASA are amending 48 CFR part 25 as set forth below:

PART 25—FOREIGN ACQUISITION
1. The authority citation for 48 CFR part 25 is revised to read as follows:

Authority:
41 U.S.C. 1121(b); 40 U.S.C. 121(c); 10 U.S.C. chapter 4 and 10 U.S.C. chapter 137 legacy provisions (see 10 U.S.C. 3016); and 51 U.S.C. 20113.
2. Amend section 25.104 by revising paragraph (a) to read as follows:
25.104
Nonavailable articles.
(a) The following articles have been determined to be nonavailable in accordance with 25.103(b)(1)(i):
(1) Antimony, as metal or oxide.
(2) Bamboo shoots.
(3) Bananas.
(4) Bismuth.
(5) Books, trade, text, technical, or scientific; newspapers; pamphlets; magazines; periodicals; printed briefs and films; not printed in the United States and for which domestic editions are not available.
(6) Brazil nuts, unroasted.
(7) Capers.
(8) Cashew nuts.
(9) Chestnuts.
(10) Chrome ore or chromite.
(11) Cocoa beans.
(12) Coconut and coconut meat, unsweetened, in shredded, desiccated, or similarly prepared form.
(13) Coffee, raw or green bean.
(14) Cork, wood or bark and waste.
(15) Cover glass, microscope slide.
(16) Fair linen, altar.
(17) Fibers of the following types: abaca, abace, agave, coir, flax, jute, jute burlaps, palmyra, and sisal.
(18) Grapefruit sections, canned.
(19) Hemp yarn.
(20) Hog bristles for brushes.
(21) Hyoscine, bulk.
(22) Modacrylic fiber.
(23) Nitroguanidine (also known as picrite).
(24) Oranges, mandarin, canned.
(25) Pineapple, canned.
(26) Quartz crystals.
(27) Rubber, crude and latex (natural).
(28) Rutile.
(29) Silk, raw and unmanufactured.
(30) Spare and replacement parts for equipment of foreign manufacture, and for which domestic parts are not available.
(31) Spices and herbs, in bulk.
(32) Swords and scabbards.
(33) Tapioca flour and cassava.
(34) Tartar, crude; tartaric acid and cream of tartar in bulk.
(35) Tea in bulk.
(36) Tin in bars, blocks, and pigs.
(37) Vanilla beans.
(38) Venom, cobra.
(39) Water chestnuts.
* * * * *
OFFICE OF MANAGEMENT AND BUDGET
Office of Federal Procurement Policy
DEPARTMENT OF DEFENSE
GENERAL SERVICES ADMINISTRATION
NATIONAL AERONAUTICS AND SPACE ADMINISTRATION
48 CFR Parts 1, 17, 33, and 52
[FAC 2025-04; Item II; Docket No. FAR-2025-0052; Sequence No. 1]
Federal Acquisition Regulation; Technical Amendments

AGENCY:
Office of Federal Procurement Policy (OFPP), Office of Management and Budget; Department of Defense (DoD); General Services Administration (GSA); and National Aeronautics and Space Administration (NASA).

ACTION:
Final rule.

SUMMARY:
This document amends the Federal Acquisition Regulation (FAR) to make needed editorial changes.

DATES:
Effective June 11, 2025.

FOR FURTHER INFORMATION CONTACT:
Ms. Lois Mandell, Regulatory Secretariat Division (MVCB), at 202-501-4755 or GSARegSec@gsa.gov. Please cite FAC 2025-04, Technical Amendments.

SUPPLEMENTARY INFORMATION:
This document makes editorial changes to 48 CFR parts 1, 17, 33, and 52.

List of Subjects in 48 CFR Parts 1, 17, 33, and 52
Government procurement.
William F. Clark,

Director, Office of Government-wide Acquisition Policy, Office of Acquisition Policy, Office of Government-wide Policy.
Therefore, OFPP, DoD, GSA, and NASA amend 48 CFR parts 1, 17, 33, and 52 as set forth below:
1. The authority citation for 48 CFR parts 1, 17, 33, and 52 is revised to read as follows:

Authority:
41 U.S.C. 1121(b); 40 U.S.C. 121(c); 10 U.S.C. chapter 4 and 10 U.S.C. chapter 137 legacy provisions (see 10 U.S.C. 3016); and 51 U.S.C. 20113.

PART 1—FEDERAL ACQUISITION REGULATIONS SYSTEM
1.401
[Amended]
2. Amend section 1.401 in paragraph (c) by removing “in 2.101” and adding “in 2.101)” in its place.

PART 17—SPECIAL CONTRACTING METHODS
17.703
[Amended]
3. Amend section 17.703 in paragraph (f) by removing “ http://www.acq.osd.mil/dpap/cpic/cp/interagency_acquisition.html ” and adding “ https://www.acq.osd.mil/asda/dpc/cp/policy/interagency-acquisition.html ” in its place.

PART 33—PROTESTS, DISPUTES, AND APPEALS
33.105
[Amended]
4. Amend section 33.105 by removing “ http://www.uscfc.uscourts.gov/rules-and-forms ” and adding “ https://www.uscfc.uscourts.gov/rules-forms ” in its place.

PART 52—SOLICITATION PROVISIONS AND CONTRACT CLAUSES
5. Amend section 52.101 by revising the introductory text of paragraph (e)(1) to read as follows:
52.101
Using part 52.
* * * * *
(e) * * *
(1) The matrix may be accessed via the internet at https://www.acquisition.gov/smart-matrix. The matrix contains a column for each principal type and/or purpose of contract ( e.g., fixed-price supply, cost reimbursement research and development). The matrix lists the—
* * * * *
6. Amend section 52.102 by revising the introductory text of paragraph (c) to read as follows:
52.102
Incorporating provisions and clauses.
* * * * *
(c) Agency approved provisions and clauses prescribed in agency acquisition regulations, and FAR provisions and clauses not authorized to be incorporated by reference as shown in the matrix at https://www.acquisition.gov/smart-matrix, need not be incorporated in full text, provided the contracting officer includes in the solicitation and contract a statement that—
* * * * *
7. Revise sections 52.300 and 52.301 to read as follows:
52.300
Scope of subpart.
The matrix contains a column for each principal type and/or purpose of contract (see 52.101(e)).
52.301
Solicitation provisions and contract clauses (Matrix).

Note:
The FAR matrix is not carried in the CFR. It is available via the internet at https://www.acquisition.gov/smart-matrix.
OFFICE OF MANAGEMENT AND BUDGET
Office of Federal Procurement Policy
DEPARTMENT OF DEFENSE
GENERAL SERVICES ADMINISTRATION
NATIONAL AERONAUTICS AND SPACE ADMINISTRATION
48 CFR Chapter 1
[Docket No. FAR-2025-0051, Sequence No. 1]
Federal Acquisition Regulation; Federal Acquisition Circular 2025-04; Small Entity Compliance Guide

AGENCY:
Office of Federal Procurement Policy (OFPP), Office of Management and Budget; Department of Defense (DoD); General Services Administration (GSA); and National Aeronautics and Space Administration (NASA).

ACTION:
Small Entity Compliance Guide (SECG).

SUMMARY:
This document is issued under the joint authority of OFPP, DoD, GSA, and NASA. This Small Entity Compliance Guide has been prepared in accordance with section 212 of the Small Business Regulatory Enforcement Fairness Act of 1996. It consists of a summary of the rules appearing in Federal Acquisition Circular (FAC) 2025-04, which amends the Federal Acquisition Regulation (FAR). Interested parties may obtain further information regarding these rules by referring to FAC 2025-04, which precedes this document.

DATES:
May 12, 2025.

ADDRESSES:
The FAC, including the SECG, is available at https://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT:
For clarification in relation to the FAR cases listed in the table below, contact FARPolicy@gsa.gov or call 202-969-4075. Please cite FAC 2025-04 and the FAR Case number. For information pertaining to status or publication schedules, contact the Regulatory Secretariat Division at 202-501-4755 or GSARegSec@gsa.gov. An asterisk (*) next to a rule indicates that a regulatory flexibility analysis has been prepared.
Rules Listed in FAC 2025-04
Item | Subject | FAR case
* I | List of Domestically Nonavailable Articles | 2020-009
II | Technical Amendments |

SUPPLEMENTARY INFORMATION:
Summaries for each FAR rule follow. For the actual revisions and/or amendments made by these FAR rules, refer to the specific item numbers and subjects set forth in the documents following these item summaries. FAC 2025-04 amends the FAR as follows:

Item I—List of Domestically Nonavailable Articles (FAR Case 2020-009)
This final rule amends the FAR to revise the list of domestically nonavailable articles under the Buy American statute. The changes are not expected to have a significant economic impact on a substantial number of small entities. It is expected that this rule will encourage small businesses to take an interest in building domestic manufacturing capabilities and capacity; this would be a positive impact though not a substantial impact.

Item II—Technical Amendments
Administrative changes are made at FAR 1.401, 17.703, 33.105, 52.101, 52.102, 52.300, and 52.301.
William F. Clark,

Director, Office of Government-wide Acquisition Policy, Office of Acquisition Policy, Office of Government-wide Policy.
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Presidential Documents
Part III
Proclamation 10933—National Foster Care Month, 2025
Proclamation 10934—Victory Day for World War II, 2025
Proclamation 10933 of May 7, 2025

National Foster Care Month, 2025
A Proclamation
Families raise our children, pass down our values, and hold communities together, forming the foundation of a strong country. Yet, far too often, for reasons beyond their control, children and young people find themselves in situations without an avenue for safe and loving care. These circumstances can be difficult for them, but it is the devoted foster parents across America who rise to the occasion with selfless compassion to ensure every child receives love, support, and a sense of belonging.
During National Foster Care Month, the First Lady and I honor the individuals and families who make room in their hearts and homes for thousands of children and youth throughout the year. Without a question, these dedicated men and women are unsung heroes in our local communities across the country for giving each child in their care as much normalcy as possible while also preparing them to be reunited with family or adopted.
My Administration estimates that, annually, more than 360,000 children and youth need the safety and stability a foster family provides. These licensed and trained foster or kinship-care families step up in times of need to offer emotional support and stability. Foster families, with the help of countless professionals and volunteers—including clergy, educators, attorneys, judges, social workers, and law enforcement personnel—can help change the course of young lives for the better. These noble caregivers devote their time and talent to ensuring every child has a safe and healthy environment in which to grow and thrive.
As a Nation of enduring faith and strong, guiding principles, every child deserves the blessings of a firm foundation and endless opportunity. That is why I proudly signed into law the landmark Family First Prevention Services Act during my first term, which utilizes evidence-based intervention methods to keep families intact, whenever possible. Targeted, proactive services—including mental health support, substance abuse treatment, in home parental skills training, housing assistance, and job training—focus on preventing the root causes of conflicts in the home.
Despite the work we have achieved, there is more to be done. That is why our First Lady is passionately focused on supporting young people through her BE BEST initiative and fostering the future for children and young adults. Her efforts help children reach their fullest potential, including transformative action for youth who have experienced foster care to help them pursue their dreams through education and continued support.
Together, we also recognize the need for more men and women to answer the call and serve as foster families. Foster families help every child realize their worth and inherent value, instilling them with the courage, character, and confidence to achieve their American Dream. We are incredibly grateful for their compassion and selfless dedication to protecting our Nation's most precious treasure.
NOW, THEREFORE, I, DONALD J. TRUMP, President of the United States of America, by virtue of the authority vested in me by the Constitution and the laws of the United States, do hereby proclaim May 2025 as National Foster Care Month. I call upon all Americans to find ways to support children and youth in foster care, and to recognize the invaluable contributions of foster parents and other caregivers.
IN WITNESS WHEREOF, I have hereunto set my hand this seventh day of May, in the year of our Lord two thousand twenty-five, and of the Independence of the United States of America the two hundred and forty-ninth.
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Presidential Documents
Proclamation 10934 of May 7, 2025

Victory Day for World War II, 2025
A Proclamation
Today, our Nation proudly commemorates the 80th anniversary of the Allied Powers' triumph over national socialism and fascism, and the end of World War II in Europe—one of the most epic victories for forces of freedom in the history of the world. On this Victory Day for World War II, we celebrate the unmatched might, strength, and power of the American Armed Forces, and we commit to protecting our sacred birthright of liberty against all threats, foreign and domestic.
In the wake of the December 7, 1941 attack on Pearl Harbor, the United States righteously entered the fray of what would become the apex of the eternal battle between good and evil. After nearly 4 years of the darkest and bloodiest chapters ever recorded in human history, more than 250,000 Americans lost their lives in the fight against the Nazi regime. Today and every day, we pay tribute to all those who made the ultimate sacrifice for their Nation, their liberty, and the survival of Western civilization. Without the sacrifice of our American soldiers, this war would not have been won, and our world today would look drastically different.
May 8, 1945 marks the Allies' acceptance of Germany's unconditional surrender—the beginning of the end of years of long, gruesome, and brutal warfare. The millions of souls senselessly lost serve as a reminder of why we must pursue peace through strength. I remain steadfastly devoted to stopping the years of endless foreign wars and preventing the further loss of lives. As I stated during my Inaugural Address, we will measure our success not only by the battles we win but also by the wars we end—and my proudest legacy will be that of a peacemaker.
As we commemorate Victory Day for World War II, we offer our unending thanks to every patriot from the Greatest Generation who left behind his home and family to fight for our freedom in distant lands. We honor the memories of all those who perished. Above all, we renew our commitment to keeping America and the entire world safe, secure, prosperous, and free.
NOW, THEREFORE, I, DONALD J. TRUMP, President of the United States of America, by virtue of the authority vested in me by the Constitution and the laws of the United States, do hereby proclaim May 8, 2025, as a day in celebration of Victory Day for World War II.
IN WITNESS WHEREOF, I have hereunto set my hand this seventh day of May, in the year of our Lord two thousand twenty-five, and of the Independence of the United States of America the two hundred and forty-ninth.