Introduction to the Unified Agenda of Federal Regulatory and Deregulatory Actions-2026

Richard Lucas, Department of Agriculture, Food and Nutrition Administration, 1320 Braddock Place, Room 555, Alexandria, VA 22314

Phone: 703 457-6797

RIN: 0584-AE71

USDA—FNA

4. ENHANCING ELECTRONIC BENEFIT TRANSFER (EBT) CARD SECURITY MEASURES

Priority: Other Significant. Major status under 5 U.S.C. 801 is undetermined.

Regulatory Accounting: Regulatory

Legal Authority: Consolidated Appropriations Act, 2023 (Pub. Law No: 117-328)

CFR Citation: Not Yet Determined

Legal Deadline: None

Abstract: This proposed rule implements Division HH, title IV, section 501(a)(2) of the Consolidated Appropriations Act, 2023. Under section 501(a)(2), the Department of Agriculture, Food and Nutrition Service (FNS) is instructed to promulgate regulations through the notice and comment process that require State agencies to implement new card security measures to protect against card skimming, card cloning, and other similar fraudulent means.

Statement of Need: This proposed rule implements Division HH, Title IV, section 501(a)(2) of the Consolidated Appropriations Act, 2023. Under section 501(a)(2), the Department of Agriculture, Food and Nutrition Service (FNS) is instructed to promulgate regulations through the notice and comment process that require State agencies to implement new card security measures to protect against card skimming, card cloning, and other similar fraudulent means.

Summary of Legal Basis: The legal authority can be found in the Consolidated Appropriations Act, 2023 (Pub. L. 117-328).

Alternatives: No reasonable alternative is known.

Anticipated Cost and Benefits: The anticipated costs and benefits will be discussed in the Regulatory Impact Analysis which will accompany the rule.

Risks: If there are any associated risks, those would be discussed in the proposed rule.

Timetable:

Action	Date	FR Cite
NPRM	09/00/26

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: State

Federalism: Undetermined

Agency Contact: Lynn Gilbert, Department of Agriculture, Food and Nutrition Administration, 1320 Braddock Place, Alexandria, VA 22314

Phone: 703 305-1615

Richard Lucas, Department of Agriculture, Food and Nutrition Administration, 1320 Braddock Place, Room 555, Alexandria, VA 22314

Phone: 703 457-6797

RIN: 0584-AE99

USDA—FNA

5. • SUPPLEMENTAL NUTRITION ASSISTANCE PROGRAM: MODIFICATION TO WORK REQUIREMENTS FOR ABLE-BODIED ADULTS

Priority: Economically Significant. Major under 5 U.S.C. 801. ( printed page 52808)

Regulatory Accounting: Regulatory

Legal Authority: Pub. L. 119-21; 7 U.S.C. 2011 to 2036

CFR Citation: 7 CFR 273

Legal Deadline: None

Abstract: This proposed rule codifies provisions of Public Law 119-21. These changes include modifying the list of exceptions from the time limit; updating requirements for areas to qualify for waivers for the time limit; and adding the temporary good faith exemptions in Alaska and Hawaii. Additionally, this rule would strengthen requirements for requesting waivers of the time limit.

Statement of Need: Changes are needed to codify provisions of Public Law 119-21 that expand the scope of participants subject to time limits, as well as changes to the requirements for States seeking waivers from time limits. The proposed changes would reflect that exemptions and exceptions from work requirements are consistent with Federal statute and provided to the appropriate populations.

Summary of Legal Basis: The legal basis for this proposed rule can be found in Public Law 119-21, Section 10102, “Modifications to SNAP work requirements for able-bodied adults”.

Alternatives: No reasonable alternative is known, given the requirements of the statute.

Anticipated Cost and Benefits: The anticipated costs and benefits will be discussed in the Regulatory Impact Analysis which will accompany the rule.

Risks: Any associated risks will be discussed in the proposed rule.

Timetable:

Action	Date	FR Cite
NPRM	07/00/26

Regulatory Flexibility Analysis Required: No

Government Levels Affected: State

Federalism: Undetermined

Agency Contact: Lynn Gilbert, Department of Agriculture, Food and Nutrition Administration, 1320 Braddock Place, Alexandria, VA 22314

Phone: 703 305-1615

Richard Lucas, Department of Agriculture, Food and Nutrition Administration, 1320 Braddock Place, Room 555, Alexandria, VA 22314

Phone: 703 457-6797

RIN: 0584-AF09

USDA—FNA

6. SUPPLEMENTAL NUTRITION ASSISTANCE PROGRAM: REFORMING CATEGORICAL ELIGIBILITY

Priority: Economically Significant. Major under 5 U.S.C. 801.

Regulatory Accounting: Regulatory

Unfunded Mandates: Undetermined

Legal Authority: 7 U.S.C. 2011 to 2036

CFR Citation: 7 CFR 273

Legal Deadline: None

Abstract: Under section 5(a) of the Food and Nutrition Act of 2008, households in which all members receive benefits under a State program funded by the Temporary Assistance to Needy Families (TANF) program are categorically eligible to participate in the Supplemental Nutrition Assistance Program (SNAP). This proposal would change the regulations at 7 CFR 273.2(j)(2) pertaining to categorically eligible TANF households by limiting categorical eligibility to certain households that receive cash TANF or other substantial assistance from TANF. The proposed revisions would create a clearer and more consistent nationwide policy that ensures categorical eligibility is extended only to households that have sufficiently demonstrated eligibility by qualifying for ongoing and substantial benefits from TANF-funded programs designed to assist households and move them towards self-sufficiency.

Statement of Need: This proposal refines SNAP eligibility requirements by reforming categorical eligibility to better serve households that have demonstrated a need for assistance. Under the proposed rule, categorical eligibility would be limited to households that receive cash or other substantial assistance from the Temporary Assistance to Needy Families (TANF) program. This change would create a clearer, more consistent nationwide policy that ensures only households truly in need and on a path to self-sufficiency are deemed eligible.

Summary of Legal Basis: The legal basis for this proposed rule can be found in 7 U.S.C. 2011-2036.

Alternatives: The Department considered alternative approaches including the ongoing and substantial framework proposed in the 2019 proposed rule. The Department believes the current proposed rule best aligns with Congressional intent for categorical eligibility; however, the Department is seeking public comment on the proposed approach.

Anticipated Cost and Benefits: The anticipated costs and benefits will be discussed in the Regulatory Impact Analysis which will accompany the rule.

Risks: Any associated risks will be discussed in the proposed rule.

Timetable:

Action	Date	FR Cite
NPRM	11/00/26

Regulatory Flexibility Analysis Required: No

Government Levels Affected: Undetermined

Federalism: Undetermined

Agency Contact: Lynn Gilbert, Department of Agriculture, Food and Nutrition Administration, 1320 Braddock Place, Alexandria, VA 22314

Phone: 703 305-1615

Richard Lucas, Department of Agriculture, Food and Nutrition Administration, 1320 Braddock Place, Room 555, Alexandria, VA 22314

Phone: 703 457-6797

RIN: 0584-AF10

USDA—FNA

7. AMENDMENT OF DEFINITION OF “ELIGIBLE FOOD” IN THE SUPPLEMENTAL NUTRITION ASSISTANCE PROGRAM (SNAP)

Priority: Other Significant

Regulatory Accounting: Regulatory

Legal Authority: 7 U.S.C. 2013(a)

CFR Citation: 7 CFR 271.2

Legal Deadline: None

Abstract: The Food and Nutrition Service is proposing to amend the definition of “eligible foods” in SNAP to align with the program's purpose of assisting low-income households in obtaining a more nutritious diet and advance USDA's goal to “Make America Healthy Again.”

Statement of Need: To ensure the SNAP program effectively serves its intended population of low-income households by providing a nutritious diet, the Food and Nutrition Service is proposing to amend the definition of “eligible foods.” This change aligns the program with its purpose of promoting better nutrition and supports USDA's goal to “Make America Healthy Again.”

Summary of Legal Basis: The legal basis for this proposed rule can be found at 7 U.S.C. 2013(a).

Alternatives: Retaining the current definition is an alternative to this reform, but the proposal better aligns the program with its purpose of promoting better nutrition.

Anticipated Cost and Benefits: Anticipated costs and benefits will be discussed in the Regulatory Impact Analysis which will accompany the rule. ( printed page 52809)

Risks: Any associated risks will be discussed in the proposed rule.

Timetable:

Action	Date	FR Cite
NPRM	12/00/26

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Richard Lucas, Department of Agriculture, Food and Nutrition Administration, 1320 Braddock Place, Room 555, Alexandria, VA 22314

Phone: 703 457-6797

RIN: 0584-AF14

USDA—FNA

8. • SUPPLEMENTAL NUTRITION ASSISTANCE PROGRAM: ALIEN ELIGIBILITY

Priority: Other Significant

Regulatory Accounting: Regulatory

Legal Authority: Pub. L. 119-21 (7 U.S.C. 2015(f))

Relevant Executive Orders: 14218

CFR Citation: 7 CFR 271; 7 CFR 273

Legal Deadline: None

Abstract: Federal law and regulations limit eligibility for SNAP benefits to U.S. citizens and certain lawfully present aliens. This proposed rule implements provisions of Public Law 119-21 which changes alien eligibility.

Statement of Need: This proposed rule would conform SNAP regulations with Public Law 119-21 and refine the eligibility requirements for aliens to ensure the SNAP program effectively serves its intended population. These changes restrict the eligibility and participation of certain aliens, building on existing Federal policy that limits SNAP benefits to U.S. citizens and certain lawfully present aliens.

Summary of Legal Basis: The legal basis for this proposed rule can be found in Public Law 119-21, Section 10108. Alien SNAP eligibility.

Alternatives: There are no known alternatives that effectively implement the requirements of the statute.

Anticipated Cost and Benefits: Anticipated costs and benefits will be discussed in the Regulatory Impact Analysis which will accompany the rule.

Risks: Any associated risks will be discussed in the proposed rule.

Timetable:

Action	Date	FR Cite
NPRM	07/00/26

Regulatory Flexibility Analysis Required: No

Government Levels Affected: State

Agency Contact: Lynn Gilbert, Department of Agriculture, Food and Nutrition Administration, 1320 Braddock Place, Alexandria, VA 22314

Phone: 703 305-1615

Richard Lucas, Department of Agriculture, Food and Nutrition Administration, 1320 Braddock Place, Room 555, Alexandria, VA 22314

Phone: 703 457-6797

RIN: 0584-AF23

USDA—FNA

9. • ENHANCING INTEGRITY IN NON-CONGREGATE MEAL SERVICE IN THE SUMMER MEAL PROGRAMS

Priority: Other Significant. Major status under 5 U.S.C. 801 is undetermined.

Regulatory Accounting: Regulatory

Legal Authority: 42 U.S.C. 1761

CFR Citation: 7 CFR parts 225, 226

Legal Deadline: None

Abstract: This rulemaking proposes changes to streamline program operations and enhance program integrity related to non-congregate meal service operations under the Summer Food Service Program (SFSP) and the National School Lunch Program's Seamless Summer Option (SSO). These updates are intended to assist State and local Program operators overcome operational challenges that limit their ability to manage these Programs efficiently and effectively. The proposed rule also includes provisions to strengthen oversight controls and ensure that summer non-congregate meal service is operated by sponsors who are best equipped to maintain program integrity.

Statement of Need: Would implement provisions of the Consolidated Appropriations Act, 2023 (Pub. L. 117-328) authorizing a rural non-congregate meal service option in the Summer Food Service Program (SFSP). This would codify the flexibility for rural program operators to provide non-congregate meal service in the SFSP. Implementation would expand the reach of FNS's summer nutrition programs, providing greater access for communities and families whom the traditional SFSP cannot reliably reach.

Summary of Legal Basis: Section 502 of the Consolidated Appropriations Act, 2023 (Pub. L. 117-328), amended section 13 of the Richard B. Russell National School Lunch Act, 42 U.S.C. 1761, to establish a non-congregate meal service option in the Summer Food Service Program.

Alternatives: None.

Anticipated Cost and Benefits: Implementation is expected to add to current program costs at the Federal, State, and local levels. Implementation is anticipated to benefit families with children by enabling families access to critical nutrition assistance for their children.

Risks: N/A.

Timetable:

Action	Date	FR Cite
NPRM	07/00/26
Final Action	09/00/27

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: Local, State, Tribal

Agency Contact: Lynn Gilbert, Department of Agriculture, Food and Nutrition Administration, 1320 Braddock Place, Alexandria, VA 22314

Phone: 703 305-1615

Richard Lucas, Department of Agriculture, Food and Nutrition Administration, 1320 Braddock Place, Room 555, Alexandria, VA 22314

Phone: 703 457-6797

RIN: 0584-AF24

USDA—FNA

10. • COMBATING FRAUD IN THE CHILD AND ADULT CARE FOOD PROGRAM AND THE SUMMER FOOD SERVICE PROGRAM

Priority: Other Significant

Regulatory Accounting: Regulatory

Legal Authority: 5 U.S.C. 552a; 42 U.S.C. 1760(r); 42 U.S.C. 1761, 1766

CFR Citation: 7 CFR parts 225, 226

Legal Deadline: None

Abstract: This rulemaking proposes changes to minimize false and fraudulent claims in the Child and Adult Care Food Program (CACFP) and the Summer Food Service Program (SFSP). The proposed changes are intended to provide State agencies and sponsoring organizations with additional tools needed to effectively and efficiently identify and remove fraudulent operators and protect taxpayer dollars in CACFP and SFSP. As an additional integrity measure, this rule also proposes to apply reciprocal disqualification procedures to school meal programs, CACFP, and SFSP as required by Section 12(r) of the National School Lunch Act (NSLA) (42 U.S.C. ( printed page 52810) 1760(r)). Finally, this rule proposes changes to the monitoring of day care homes and modifies recordkeeping requirements.

Statement of Need: The rule is consistent with the Administration's priority to promote fiscal responsibility and minimize fraudulent claims in the Child and Adult Care Food Program and the Summer Food Service Program by providing State agencies and sponsoring organizations with new tools to effectively identify and remove fraudulent operators.

Summary of Legal Basis: Richard B. Russell National School Lunch Act.

Alternatives: None identified.

Anticipated Cost and Benefits: Costs to State agencies and program operators to be determined are expected to be outweighed by minimizing false and fraudulent claims and strengthen integrity measures to save taxpayer dollars.

Risks: None identified.

Timetable:

Action	Date	FR Cite
NPRM	07/00/26
Final Action	11/00/27

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: Local, State, Tribal

Agency Contact: Lynn Gilbert, Department of Agriculture, Food and Nutrition Administration, 1320 Braddock Place, Alexandria, VA 22314

Phone: 703 305-1615

Richard Lucas, Department of Agriculture, Food and Nutrition Administration, 1320 Braddock Place, Room 555, Alexandria, VA 22314

Phone: 703 457-6797

RIN: 0584-AF25

USDA—FNA

11. • SPECIAL SUPPLEMENTAL NUTRITION PROGRAM FOR WOMEN, INFANTS AND CHILDREN (WIC) PROGRAM INTEGRITY

Priority: Other Significant

Regulatory Accounting: Regulatory

Legal Authority: Pub. L. 89-642

CFR Citation: 7 CFR part 246.2, 246.4, 246.7, 246.12; 246.1

Legal Deadline: None

Abstract: The proposed rule would modernize vendor integrity requirements by reflecting the WIC program's nationwide implementation of electronic benefits transfer (EBT) and its move away from paper-based processes. It would advance security requirements to protect WIC participants' personal information and taxpayers in a modern marketplace. Further, it would enhance requirements regarding State agency vendor selection criteria and investigation techniques to reduce vendor fraud, abuse, and waste. The rule would also strengthen vendor investigation, violation, and sanction regulatory requirements.

Statement of Need: To strengthen program integrity in the WIC program, this proposed rule modernizes vendor integrity requirements by shifting from paper-based to electronic benefits transfer (EBT) processes nationwide. The regulations will protect WIC participants' personal information and taxpayer funds. Furthermore, the rule enhances state agency vendor selection criteria and investigation techniques to reduce vendor fraud, abuse, and waste. Stronger regulatory requirements for vendor investigations, violations, and sanctions will significantly improve oversight.

Summary of Legal Basis: The legal basis for this proposed rule can be found in Public Law 89-642.

Alternatives: There are no known alternatives that prevent program abuse and enhance integrity in the modern electronic benefits transfer operational environment as effectively as the proposed rule.

Anticipated Cost and Benefits: Anticipated costs and benefits will be discussed in the Regulatory Impact Analysis which will accompany the rule.

Risks: Any associated risks will be discussed in the proposed rule.

Timetable:

Action	Date	FR Cite
NPRM	09/00/26
Final Action	03/00/28

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected: Businesses

Government Levels Affected: Federal, Local, State, Tribal

Federalism: Undetermined

Agency Contact: Lynn Gilbert, Department of Agriculture, Food and Nutrition Administration, 1320 Braddock Place, Alexandria, VA 22314

Phone: 703 305-1615

Richard Lucas, Department of Agriculture, Food and Nutrition Administration, 1320 Braddock Place, Room 555, Alexandria, VA 22314

Phone: 703 457-6797

RIN: 0584-AF26

USDA—FNA

12. SPECIAL SUPPLEMENTAL NUTRITION PROGRAM FOR WOMEN, INFANTS AND CHILDREN (WIC): WIC ONLINE ORDERING AND TRANSACTIONS AND FOOD DELIVERY REVISIONS TO MEET THE NEEDS OF A MODERN, DATA-DRIVEN PROGRAM

Priority: Other Significant

Regulatory Accounting: Deregulatory

Legal Authority: Pub. Law 111-296

CFR Citation: 7 CFR 246.2; 7 CFR 246.4; 7 CFR 246.12

Legal Deadline: None

Abstract: This “final rule with comment” addresses key regulatory barriers to online ordering in the WIC Program by making changes to the provisions that prevent online transactions and types of online capable stores from participating in the Program. This rule will also allow FNS to modernize WIC vendor regulations that do not reflect current technology and facilitate the Program's transition to Electronic Benefit Transfer (EBT). The final rule is responsive to prior proposed rule public comments from WIC state, public and private industry stakeholders to ensure that the final rule reflects their substantive feedback as online shopping and FNS' modernization efforts are made permanent.

Statement of Need: USDA FNS will set forth final rulemaking to reduce barriers to WIC Program services, foster innovation in the retail market, and provide the best possible customer service to participants. The retail grocery industry has changed over the past several years. Online shopping has become an increasingly common method for purchasing groceries. Pursuing online ordering in WIC will ensure that WIC participants have access to a broader array of shopping options and are not left behind as the industry continues to innovate. Households that participate in WIC should have the opportunity to shop for foods, especially those needed to address nutritional deficits, the way others shop for food, by ordering online. State agencies have been able to request and receive waivers from these regulatory barriers as a result of shorter-term statutory flexibilities. A long-term solution is required in order to continue to support modernization of the WIC program.

Summary of Legal Basis: Pub. L. 111-296 ( printed page 52811)

Alternatives: None identified at this time.

Anticipated Cost and Benefits: This will be discussed in the Regulatory Impact Analysis to accompany the regulation.

Risks: Risks, if any, would be discussed in the regulation.

Timetable:

Action	Date	FR Cite
NPRM	02/23/23	88 FR 11516
NPRM Comment Period End	05/24/23
Final Action	07/00/26

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: Federal, Local, State, Tribal

Agency Contact:, Lynn Gilbert, Department of Agriculture, Food and Nutrition Administration, 1320 Braddock Place, Alexandria, VA 22314

Phone: 703 305-1615

Richard Lucas, Department of Agriculture, Food and Nutrition Administration, 1320 Braddock Place, Room 555, Alexandria, VA 22314

Phone: 703 457-6797

RIN: 0584-AE85

USDA—FNA

13. UPDATED STAPLE FOOD STOCKING STANDARDS FOR RETAILERS IN THE SUPPLEMENTAL NUTRITION ASSISTANCE PROGRAM

Priority: Other Significant

Regulatory Accounting: Regulatory

Legal Authority: Pub. L. 113-79; 7 U.S.C. 2011 to 2036

Relevant Executive Orders: 14212

CFR Citation: 7 CFR 271; 7 CFR 278

Legal Deadline: None

Abstract: The Agricultural Act of 2014 amended the Food and Nutrition Act of 2008 to increase the requirement that certain Supplemental Nutrition Assistance Program (SNAP) authorized retail food stores have available on a continuous basis at least three varieties of items in each of food staple food categories, to a mandatory minimum of seven varieties. This final rule would provide some retailers participating in SNAP as authorized food stores with more flexibility in meeting the enhanced SNAP eligibility requirements while also simplifying the criteria.

Statement of Need: This final rule refines the eligibility requirements for retailers participating in the SNAP program. The updated standards implement the Agricultural Act of 2014 by increasing the minimum number of varieties for food staples from three to seven. These changes aim to ensure that authorized retailers can effectively serve the intended population of SNAP participants by offering a wider variety of staple foods. The rule also provides some flexibility for retailers while simplifying the overall criteria.

Summary of Legal Basis: The legal basis for this rule can be found in the Agricultural Act of 2014 (Pub. L. 113-79), as codified at 7 U.S.C. 2011-2036.

Alternatives: There are no known alternatives that implement the enhanced stocking requirements of Pub L. 113-79 in ways that are practical and flexible for SNAP-authorized retailers.

Anticipated Cost and Benefits:

Benefits: The proposed rule will increase the variety of staple food products offered for sale at SNAP-authorized firms, which will help to ensure that SNAP households have access to healthier foods on a continuous basis.

Costs: The Department has estimated the proposed rule's total cost to the Federal Government as approximately $4 million in fiscal year (FY) 2027, and to incur no further costs after implementation. The cost to currently authorized retailers is estimated to be approximately $55 million in the first year and about $2 million per year over the following four years.

Risks: Any associated risks will be discussed in the rule.

Timetable:

Action	Date	FR Cite
NPRM	09/25/25	90 FR 46081
Final Action	07/00/26

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: Undetermined

Agency Contact: Lynn Gilbert, Department of Agriculture, Food and Nutrition Administration, 1320 Braddock Place, Alexandria, VA 22314

Phone: 703 305-1615

Richard Lucas, Department of Agriculture, Food and Nutrition Administration, 1320 Braddock Place, Room 555, Alexandria, VA 22314

Phone: 703 457-6797

Related RIN: Related to 0584-AE27

RIN: 0584-AF12

USDA—Food Safety and Inspection Service (FSIS)	Proposed Rule Stage

14. MAXIMUM LINE SPEED RATES FOR YOUNG CHICKEN AND TURKEY ESTABLISHMENTS OPERATING UNDER THE NEW POULTRY INSPECTION SYSTEM

Priority: Economically Significant. Major under 5 U.S.C. 801.

Regulatory Accounting: Deregulatory

Legal Authority: 21 U.S.C. 451, et. seq.

Relevant Executive Orders: 14212; 14267

CFR Citation: 9 CFR part 381

Legal Deadline: None

Abstract: The Food Safety and Inspection Service (FSIS) is proposing to amend the regulations that prescribe the maximum line speed rates under the New Poultry Inspection System (NPIS) to allow NPIS young chicken and turkey establishments to operate at more efficient line speeds.

Statement of Need: This proposed rule is needed to give poultry slaughter establishments the ability to operate under inspection systems and at line speeds that would allow them slaughter birds more efficiently without the need for a regulatory waiver while continuing to ensure food safety and effective FSIS online carcass inspection.

Summary of Legal Basis: FSIS has been delegated the authority to exercise the functions of the Secretary (7 CFR 2.18, 2.53), as specified in the Poultry Products Inspection Act (21 U.S.C 451 et seq.). This statute mandates that FSIS protect the public by verifying that poultry products are safe, wholesome, unadulterated, and properly labeled and packaged. The PPIA also requires, among other things, that [t]he Secretary [of Agriculture], whenever processing operations are being conducted, shall cause to be made by inspectors postmortem inspection of the carcasses of each bird processed (21 U.S.C. 455(b)). The PPIA provides that the Secretary shall promulgate such other rules and regulations as are necessary to carry out the provisions of the statutes (21 U.S.C. 463(b)).

Alternatives: FSIS may consider alternatives during the development of the proposed rule.

Anticipated Cost and Benefits: Overall, this proposed rule would benefit establishments that slaughter poultry, other than ratites, by ending the need for certain waivers. The proposed rule would allow certain poultry establishments to increase efficiency and decrease production costs by eliminating unnecessary barriers efficiency while maintaining or even improving food safety.

Allowing additional NPIS young chicken and young turkey ( printed page 52812) establishments to operate at more efficient line speeds would likely result in cost savings through reducing their production costs by using resources more efficiently and optimizing their production process. Further, allowing non-NPIS establishments that slaughter poultry classes other than ratites to operate under NPIS or SIS would give industry additional flexibility to choose the inspection system that is best suited for their operations.

If NPIS establishments currently operating without a line speed waiver choose to increase their line speeds, they would likely incur costs associated with hiring additional labor, training, and Hazard Analysis and Critical Control Point (HACCP) plan reassessment. An establishment would only incur these costs if the benefits outweigh the costs, since the choice to operate at increased line speeds is a voluntary business decision.

Risks: If the Agency does not proceed with the proposed poultry line speed rule, establishments may continue to be unable to operate at full capacity. This could limit the number of birds processed each day, slow production, and create inefficiencies across the supply chain. Without a clear regulatory framework to increase line speeds, establishments may delay investments in modernization and may not operate under NPIS, which could reduce productivity, make it harder for the industry to respond to market demand, and increase Agency costs.

Timetable:

Action	Date	FR Cite
NPRM	02/19/26	91 FR 7926
NPRM Comment Period End	04/20/26

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Melissa Hammar, Director, Regulations Development Staff, Department of Agriculture, Food Safety and Inspection Service, 1400 Independence Avenue SW, Washington, DC 20250

Phone: 202 286-2255

RIN: 0583-AE01

USDA—FSIS

15. MAXIMUM LINE SPEED UNDER THE NEW SWINE SLAUGHTER INSPECTION SYSTEM (NSIS)

Priority: Economically Significant. Major under 5 U.S.C. 801.

Regulatory Accounting: Deregulatory

Legal Authority: 21 U.S.C. 601, et. seq.

Relevant Executive Orders: 14212; 14267

CFR Citation: 9 CFR part 310

Legal Deadline: None

Abstract: The Food Safety and Inspection Service (FSIS) is proposing to amend the pork products inspection regulations to eliminate line speed limits for NSIS establishments and allow NSIS establishments to determine their line speeds based on their ability to maintain process control. FSIS intends to republish 9 CFR 310.26(c) (previously struck down by the U.S. District Court of the District of Minnesota) to eliminate the existing maximum line speed of 1,106 head per hour (hph) for NSIS establishments. The worker safety study found that line speed is not a leading factor for work-related musculoskeletal disorders (MSDs) in swine slaughter establishments.

Statement of Need: In October 2019, FSIS established the NSIS (84 FR 52300). The NSIS regulations, among other things, eliminated the existing maximum line speed of 1,106 hph for NSIS establishments and authorized establishments to determine their own line speeds based on their ability to maintain process control and food safety.

On June 30, 2021, based on a court decision, all NSIS establishments had to return to a maximum linespeed of 1,106 hph, unless an establishment has obtained a regulatory waiver from FSIS.

In November 2021, in response to a court decision, FSIS announced that the agency, in collaboration with OSHA, developed a time-limited trial (TLT) that allowed existing NSIS establishments to experiment with ergonomics, automation, and crewing to create custom work environments that will both protect food safety and worker safety while increasing productivity. The TLT has allowed six NSIS establishments to operate at increased line speeds under regulatory waivers. During the TLT, third-party contractors that the Agency hired to conduct a worker safety study in NSIS establishments collected data that measures how evisceration line speeds impact work-related MSD risk.

In January 2025,USDA published the contractor's report on the linespeed worker safety study.The study concluded that piece rate ( i.e., the number of hog parts handled per minute by a worker) is a better measure of MSD risk than line speed and that all establishments, regardless of current or anticipated future increased line speed, can mitigate MSD risk by increasing job-specific staffing levels, decreasing job-specific line speeds, or both. On March 17, 2025, USDA announced that it would extend the waivers and that rulemaking to propose line speed increases would begin immediately.

Summary of Legal Basis: FSIS has been delegated the authority to exercise the functions of the Secretary (7 CFR 2.18, 2.53), as specified in the FMIA. This statute mandates that FSIS protect the public by verifying that meat products are safe, wholesome, unadulterated, and properly labeled and packaged. The Act also prohibits the distribution in commerce of any meat products that are adulterated or misbranded. The FMIA gives FSIS broad authority to promulgate such rules and regulations as are necessary to carry out provisions of the Act (21 U.S.C. 621).

Alternatives: FSIS may consider alternatives during the development of the proposed rule.

Anticipated Cost and Benefits: Republishing and amending 9 CFR 310.26(c) to eliminate maximum linespeeds at NSIS establishments would reduce regulatory uncertainty and allow industry to operate more efficiently, likely reducing their production costs by optimizing their production process without compromising food safety.

This proposed rule, if finalized, would benefit NSIS establishments operating with a line speed waiver by eliminating potential regulatory uncertainty regarding the duration of the waivers. Allowing NSIS establishments currently operating without a line speed waiver to operate without a line speed limit would likely result in cost savings through reducing their production costs. This proposed rule may also benefit non-NSIS establishments that voluntarily choose to switch to NSIS and operate at more efficient line speeds.

If an NSIS establishment currently operating without a line speed waiver chooses to increase their line speeds, they would likely incur costs associated with hiring additional labor, training, and Hazard Analysis and Critical Control Point (HACCP) plan reassessment. Non-NSIS establishments that voluntarily choose to convert to NSIS would incur costs for hiring additional labor, training, ready to cook requirements, and HACCP plan reassessment. An establishment would only incur these costs if the benefits outweigh the costs, since the choice to operate at increased line speeds is a voluntary business decision.

Risks: If the Agency does not proceed with the proposed swine line speed rule, establishments may continue to be ( printed page 52813) unable to operate at full capacity. This could limit the number of animals processed each day, slow production, and create inefficiencies across the supply chain. Without a clear regulatory framework to increase line speeds, establishments may delay investments in modernization and may not operate under NSIS, which could reduce productivity, make it harder for the industry to respond to market demand, and increase Agency costs.

Timetable:

Action	Date	FR Cite
NPRM	02/19/26	91 FR 7905
NPRM Comment Period End	04/20/26

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Melissa Hammar, Director, Regulations Development Staff, Department of Agriculture, Food Safety and Inspection Service, 1400 Independence Avenue SW, Washington, DC 20250

Phone: 202 286-2255

RIN: 0583-AE02

USDA—FSIS

16. • MODERNIZATION OF BEEF SLAUGHTER INSPECTION

Priority: Other Significant

Regulatory Accounting: Regulatory

Legal Authority: 21 U.S.C. 601 et seq.

Relevant Executive Orders: 14212; 14267

CFR Citation: 9 CFR parts 301, 307, and 310

Legal Deadline: None

Abstract: The Food Safety and Inspection Service (FSIS) intends to propose amendments to the Federal meat inspection regulations to create an optional new inspection system for beef slaughter establishments. The system is expected to help FSIS use its resources more efficiently while still providing a level of public health protection equivalent to the current inspection system. It would also remove unnecessary regulatory obstacles to innovation. Establishments that do not opt in would continue under their current inspection system. FSIS also intends to propose changes that would apply to all beef slaughter establishments, giving them more flexibility to design sampling plans that fit their operations and improve how they monitor process control.

Statement of Need: The proposed action is necessary to make better use of the Agency's resources and remove unnecessary regulatory obstacles to innovation.

Alternatives: FSIS may consider alternatives during the development of the proposed rule.

Anticipated Cost and Benefits: The proposed regulations are expected to benefit beef slaughter establishments by removing unnecessary regulatory obstacles to innovation and allowing establishments more flexibility in how they configure their slaughter lines. The proposed changes are also expected to reduce establishments' sampling costs. FSIS anticipates that the proposed actions would make better use of the Agency's resources, which may reduce personnel and training costs. Establishments may incur increased labor and recordkeeping costs as a result of the proposed requirements.

Risks: If FSIS does not move forward with this rulemaking, establishments may continue to face regulatory requirements that limit their ability to adjust line configurations or adopt new technologies. Without changes to the current regulations, establishments may also continue to incur higher sampling costs and have fewer options for tailoring their food safety procedures to their specific operations. In addition, FSIS may need to maintain higher staffing levels and continue investing in training for inspection procedures that could be streamlined. This could limit the Agency's ability to use its resources more efficiently and respond to changing inspection needs across the industry.

Timetable:

Action	Date	FR Cite
NPRM	11/00/26

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Melissa Hammar, Director, Regulations Development Staff, Department of Agriculture, Food Safety and Inspection Service, 1400 Independence Avenue SW, Washington, DC 20250

Phone: 202 286-2255

RIN: 0583-AE08

USDA—FSIS	Final Rule Stage

17. REVISION OF THE NUTRITION FACTS LABELS FOR MEAT AND POULTRY PRODUCTS AND UPDATING CERTAIN REFERENCE AMOUNTS CUSTOMARILY CONSUMED

Priority: Other Significant

Regulatory Accounting: Regulatory

Legal Authority: 21 U.S.C. 601 et seq.;21 U.S.C. 451 et seq.

Relevant Executive Orders: 14212

CFR Citation: 9 CFR part 317; 9 CFR part 381; 9 CFR part 413

Legal Deadline: None

Abstract: Consistent with the changes that the Food and Drug Administration (FDA) finalized, the Food Safety and Inspection Service (FSIS) is amending the Federal meat and poultry products inspection regulations to update and revise the nutrition labeling requirements for meat and poultry products to reflect recent scientific research and dietary recommendations and to improve the presentation of nutrition information to assist consumers in maintaining healthy dietary practices.

Statement of Need: On May 27, 2016, the Food and Drug Administration (FDA) published two final rules: (1) “Food Labeling: Revision of the Nutrition and Supplement Facts Labels” (81 FR 33742); and (2) “Food Labeling: Serving Sizes of Foods that Can Reasonably be Consumed at One Eating Occasion; Dual-Column Labeling; Updating, Modifying, and Establishing Certain Reference Amounts Customarily Consumed; Serving Size for Breath Mints; and Technical Amendments” (81 FR 34000). FDA finalized these rules to update the Nutrition Facts label to reflect new nutrition and public health research, to reflect recent dietary recommendations from expert groups, and to improve the presentation of nutrition information to help consumers make more informed choices and maintain healthy dietary practices. FSIS has reviewed FDA's analysis and, to ensure that nutrition information is presented consistently across the food supply, FSIS is amending the nutrition labeling regulations for meat and poultry products to parallel, to the extent possible, FDA's regulations. This approach will help increase clarity of information for consumers and will improve efficiency in the marketplace. ( printed page 52814)

Summary of Legal Basis: Under the Federal Meat Inspection Act (FMIA) (21 U.S.C. 601-695, at 607), the Poultry Products Inspection Act (PPIA) (21 U.S.C. 451-470, at 457), and the Egg Products Inspection Act (21 U.S.C. 1031-1056, at 1036) (the Acts), the labels of meat, poultry, and egg products must be approved by the Secretary of Agriculture, who has delegated this authority to FSIS, before these products can enter commerce. The Acts prohibit the sale or offer for sale by any person, firm, or corporation of any article in commerce under any name or other marking or labeling that is false or misleading or in any container of a misleading form or size (21 U.S.C. 607(d); 21 U.S.C. 457(c)). The Acts also prohibit the distribution in commerce of meat or poultry products that are adulterated or misbranded. The FMIA and PPIA give FSIS broad authority to promulgate such rules and regulations as are necessary to carry out the provisions of the Acts (21 U.S.C. 621 and 463(b)).

To prevent meat and poultry products from being misbranded, the meat and poultry product inspection regulations require that the labels of meat and poultry products include specific information, such as nutrition labels, and that such information be displayed as prescribed in the regulations (9 CFR parts 317 and 381). The nutrition labeling requirements for meat and meat food products are in 9 CFR 317.300-317.400, and the nutrition labeling requirements for poultry products are in 9 CFR 381.400-381.500.

Alternatives: FSIS considered five alternatives in the proposed rule: (1.) No action; (2.) A 24-month compliance period for large manufacturers and a 36-month compliance period for small manufacturers (as proposed); (3.) A 42-month compliance period for all manufacturers; (4.) A 24-month compliance period for all manufactures; or (5.) A 12-month compliance period for large manufacturers and a 24-month compliance period for small manufacturers.

Anticipated Cost and Benefits: These regulations are expected to benefit consumers by increasing and improving dietary information available in the market. Firms will incur a one-time cost for relabeling, recordkeeping costs, and costs associated with voluntary reformulation. Many firms have voluntarily begun using the FDA format, which will reduce costs.

Risks: None

Timetable:

Action	Date	FR Cite
NPRM	01/19/17	82 FR 6732
NPRM Comment Period End	04/19/17
Final Action	07/00/26

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Melissa Hammar, Director, Regulations Development Staff, Department of Agriculture, Food Safety and Inspection Service, 1400 Independence Avenue SW, Washington, DC 20250-3700

Phone: 202 286-2255

RIN: 0583-AD56

USDA—Forest Service (FS)	Proposed Rule Stage

18. SPECIAL AREAS: ROADLESS AREA CONSERVATION REPEAL

Priority: Other Significant. Major status under 5 U.S.C. 801 is undetermined.

Regulatory Accounting: Deregulatory

Legal Authority: 16 U.S.C. 472, 551, and 1604; 42 U.S.C. 4321

Relevant Executive Orders: 14308; 14153; 14219

CFR Citation: 36 CFR 294

Legal Deadline: None

Abstract: The rulemaking would repeal 36 CFR 294 subpart B, which established prohibitions on road construction, road reconstruction, and timber harvesting in inventoried roadless areas on National Forest System lands. With the repeal, management requirements for inventoried roadless areas would be guided by individual land management plans. This rulemaking is in accordance with Executive Order 14153, Unleashing Alaska's Extraordinary Resource Potential, section 3(c), which directs the Secretary of Agriculture to reinstate the 2020 Alaska Roadless Rule (85 FR 68688). By removing the nationwide roadless standard under the 2001 Roadless Rule, a Tongass National Forest exemption under the 2020 Alaska Roadless Rule is no longer needed.

Statement of Need: The Department of Agriculture (USDA) is proposing this rule to establish a more effective and efficient administrative framework for managing the National Forest System's (NFS) inventoried roadless areas (IRAs). The current 2001 Roadless Rule established a single, nationwide set of prohibitions on road construction, road reconstruction, and timber harvesting in IRAs. The Department believes that this “one-size-fits-all” approach is no longer appropriate given changing resource conditions and shifts in policy priorities.

The promulgation of this rule will:

1. Address Evolving Conditions and Policy Priorities: Resource conditions within and adjacent to NFS lands have dramatically changed since 2001, including the expansion of the wildland-urban interface, growing impacts of extreme wildfire, drought, and insect and disease infestations. Management flexibility is required for the Agency to achieve its multiple-use conservation mission, including wildfire suppression and fuel reduction treatments.

2. Align with National Directives: This action is being proposed in accordance with Executive Order 14192, Unleashing Prosperity Through Deregulation, to alleviate unnecessary regulatory burdens. It also responds to Executive Order 14153, Unleashing Alaska's Extraordinary Resource Potential, which directs the Secretary of Agriculture to reinstate the 2020 Alaska Roadless Rule (the effect of which is achieved by rescinding the nationwide rule).

3. Restore Local Management Flexibility: Rescinding the 2001 Roadless Rule would return discretion for local land managers to tailor management, as appropriate, to local land conditions. Conservation and management of roadless area characteristics can be more effectively achieved through the robust public process and site-specific analysis inherent in the National Forest Management Act (NFMA) forest planning framework. This approach addresses longstanding administrative and policy challenges that have created uncertainty since 2001.

4. Enable Economic Development: The rule aims to enable job creation and economic development in rural America through responsible timber production and promotion of direct and indirect forest-related jobs.

Summary of Legal Basis: The Secretary of Agriculture has broad authority to protect and administer the National Forest System (NFS) through regulation. The legal basis for this rulemaking stems primarily from:

The Organic Administration Act of 1897 (Organic Act): This Act provides the Secretary with the authority to issue rules and regulations to “regulate the occupancy and use of the forests and to preserve them from destruction”.
The Multiple-Use Sustained-Yield Act of 1960 (MUSYA): This Act mandates the Forest Service to manage NFS lands for multiple uses and sustained yield of renewable surface ( printed page 52815) resources to meet the needs of the American people.
The National Forest Management Act of 1976 (NFMA): This statute requires the Forest Service to prepare comprehensive land and resource management plans (forest plans) for each NFS unit. The decision to rescind the national prohibition is an exercise of the Secretary's discretion to determine the proper uses within any area.

This proposed rule is an exercise of the Secretary of Agriculture's discretion to determine the most appropriate administrative process for balancing competing values and uses in IRAs.

Alternatives: The Environmental Impact Statement (EIS) being prepared to analyze this proposal will evaluate the effects of the proposed action and a reasonable range of alternatives. The alternatives generally include:

1. Proposed Action (Rescission of the 2001 Roadless Rule): The USDA proposes to rescind the 2001 Roadless Area Conservation Rule (36 CFR Subpart B), including its application to the Tongass National Forest, while maintaining the state-specific roadless conservation rules for Idaho (36 CFR Subpart C) and Colorado (36 CFR Subpart D). This action would remove the nationwide prohibitions on road construction, road reconstruction, and timber harvesting on IRAs, returning decision-making authority to local land managers guided by existing Forest-level land management plans.

2. No Action Alternative: This alternative would retain the 2001 Roadless Rule in its current form. This maintains the designation of 9,368,000 acres of IRAs on the Tongass (as established in 2001) and continues the prohibitions on timber harvest and road construction/reconstruction nationwide, with limited exceptions. The No Action Alternative serves as the baseline condition for comparison.

3. Other Alternatives for Roadless Area Conservation: The EIS will study alternatives for roadless area conservation on NFS lands, including the Tongass National Forest, in the context of multiple-use management.

Anticipated Cost and Benefits: The benefits and costs associated with rescinding the 2001 Roadless Rule are largely programmatic and are generally described qualitatively.

Anticipated Benefits:

Increased Management Flexibility: Provides local land managers the flexibility needed to respond to changing local conditions, such as reducing the risk of uncharacteristic wildfire effects and addressing insect and disease infestations.
Economic Opportunity: Potentially expands the land base available for timber harvest and offers greater flexibility in locating and designing timber sales. This improved flexibility could improve the Forest Service's ability to offer economic sales that contribute to rural economies.
Infrastructure and Development: Benefits for the transportation, infrastructure, and mineral development sectors are anticipated due to the rescission of prohibitions on road building.
Local Decision-making: Returns decision-making authority to the local forest level, potentially enhancing local collaboration and aligning management with regional goals.

Anticipated Costs:

Loss of Roadless Values: Increased development (road construction/reconstruction and timber harvest) resulting from the proposed rule could adversely affect the scenic beauty of roadless areas, water quality, fisheries, wildlife, and associated recreation opportunities. Road construction, reconstruction, and timber harvest pose the greatest risks of altering and fragmenting natural landscapes.
Increased Administrative Costs: The proposed rule may result in increased administrative costs related to the necessary maintenance of any new roads constructed.
Distributional Effects: While the overall change in resource availability across most regions is expected to be small, effects may be more pronounced in specific regions (e.g., Alaska).

Risks: The programmatic nature of this rulemaking means that specific on-the-ground risks are difficult to quantify, but potential risks include:

1. Environmental Degradation: The primary risk is the loss of the ecological and social values afforded by IRAs, such as high quality or undisturbed soil, water, and air; sources of public drinking water; diversity of plant and animal communities; and habitat for sensitive species.

2. Increased Public Controversy and Litigation: The rule is expected to generate significant public interest, including strong opposition from some state and local governments, Tribal communities, and environmental groups concerned about diminished protections. There is ongoing litigation related to roadless areas, particularly concerning the Tongass National Forest. Rescinding the rule may exacerbate controversy by replacing national uniformity with varying, localized management approaches.

3. Impacts on Subsistence Uses (Tongass Context): In the context of the Tongass, removing the 2001 Roadless Rule protections increases the risk of adverse effects to subsistence uses due to increased competition for resources or impacts on resource distribution and abundance, particularly deer habitat.

4. Compliance and Consultation Risk: Although the agency maintains commitment to consultation, the rulemaking must ensure compliance with requirements such as the Endangered Species Act (ESA) and Executive Order 13175 (Tribal Consultation), as programmatic rules affecting vast areas carry inherent risk regarding potential effects on threatened and endangered species or Tribal interests.

Timetable:

Action	Date	FR Cite
NPRM	07/00/26

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Agency Contact: Nathan Morris, Department of Agriculture, Forest Service, 201 14th Street SW, Washington, DC 20024

Phone: 202 205-0833

Email: nathan.morris@usda.gov

RIN: 0596-AD66

BILLING CODE 3410-90-P

Department Of Commerce

Statement of Regulatory and Deregulatory Priorities

Established in 1903, the Department of Commerce (Commerce or Department) is one of the oldest Cabinet-level agencies in the Federal Government. Commerce's mission is to create the conditions for economic growth and opportunity across American communities by promoting innovation, entrepreneurship, competitiveness, national security, and environmental stewardship. Commerce has 13 operating units, which manage a diverse portfolio of programs and services ranging from export controls, trade promotion, and improved broadband access to overseeing the National Weather Service, developing standards for the U.S. and the world, and producing statistical data. The Department executes the census, oversees the Patent and Trademark Office, and take care of the nation's oceans and fisheries. Across these varied activities, Commerce seeks to provide a foundation for a more dynamic, resilient, and globally competitive economy.

To fulfill its mission, Commerce works in partnership with businesses, ( printed page 52816) educational institutions, community organizations, government agencies, and individuals to:

Innovate by developing new ideas through cutting-edge science and technology, from advances in nanotechnology to ocean exploration to broadband deployment, and by protecting and incentivizing American innovations through the patent and trademark system;
Promote entrepreneurship and commercialization by strengthening capital markets, incentivizing growth, facilitating community development, and empowering small businesses.
Maintain U.S. economic competitiveness in the global marketplace by promoting exports and foreign direct investment, securing a level playing field for U.S. businesses, and ensuring that technology transfer is consistent with our nation's economic and security interests;
Provide effective management and stewardship of our nation's resources and assets to ensure sustainable economic opportunities; and
Make informed policy decisions and enable better understanding of the economy and our communities by providing timely, accessible, and accurate economic and demographic data.

Commerce's Regulatory Plan tracks the most important regulations that the Department anticipates issuing to implement these policy and program priorities and foster new and sustainable growth. Of Commerce's 13 primary operating units, three bureaus—the National Oceanic and Atmospheric Administration (NOAA), the United States Patent and Trademark Office (USPTO), and the Bureau of Industry and Security (BIS)—issue the vast majority of the Department's regulations, and these three bureaus account for all the planned actions that are considered the Department's most important significant pre-regulatory or regulatory actions for FY 2026.

Consistent with Executive Order 14094, moreover, the Department and its bureaus routinely seek to inform their rulemaking with meaningful opportunities for public input. The efforts of NOAA, USPTO, and BIS to promote public engagement are discussed in their respective sections, below.

National Oceanic and Atmospheric Administration

NOAA's mission is built on three pillars: science, service, and stewardship—to understand and predict changes in climate, weather, oceans, and coasts; to share that knowledge and information with others; and to conserve and manage coastal and marine ecosystems and resources.

NOAA seeks to conserve our lands, waters, and natural resources, protecting people and the environment now and for future generations. As part of Commerce, moreover, NOAA recognizes that environmental stewardship must go hand-in hand with economic growth. For example, with respect to the nation's fisheries, NOAA looks simultaneously to ensure sustainability and optimize resources in order to boost long-term economic growth and competitiveness in the vital fisheries sector of the U.S. economy. In doing so, we are guided by the ambitious agenda to revitalize our U.S. fisheries set forth by the President in E.O. 14276, “Restoring American Seafood Competitiveness.” Similarly, national marine sanctuaries both protect important natural resources and also are significant drivers of eco-tourism and local recreation.

Within NOAA, the National Marine Fisheries Services (NMFS) and the National Ocean Service (NOS) are the components that most often exercise regulatory authority to implement NOAA's mission. NMFS oversees the management and conservation of the nation's marine fisheries; protects marine mammals and Endangered Species Act (ESA)-listed marine and anadromous species; authorizes incidental take of marine mammals and provides consultations for interagency partners when ESA-listed species may be affected by certain activities that are important to the economy, national security, or other reasons; and promotes economic development of the U.S. fishing industry. NOS supports the coastal states in their management of land and ocean resources in their coastal zones, including estuarine research reserves; manages national marine sanctuaries; monitors marine pollution; and directs the national program for deep-seabed minerals and ocean thermal energy.

In FY 2025, the agency finalized 5 deregulatory actions (RINs 0648-BN45, 0648-BN64, 0648-BN51, 0648-BN18, and 0648-BN36) as defined under E.O. 14192, “Unleashing Prosperity Through Deregulation” and anticipates finalizing approximately 14 more in FY 2026 (RINs 0648-BL64, 0648-BM54, 0648-BN70, 0648-BN52, 0648-BN90, 0648-BM08, 0648-BN68, 0648-BN55, 0648-BN43, 0648-BI10, 0648-BN60, 0648-BN24, 0648-BN59, and 0648-BN95).

Many of NOAA's rulemakings, of which roughly 13 are expected to be significant rulemakings, as defined in Executive Order 12866, are issued pursuant to the following key statutes:

Magnuson-Stevens Fishery Conservation and Management Act

Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act) rulemakings concern the conservation and management of fishery resources in the U.S. Exclusive Economic Zone (generally 3-200 nautical miles from shore). Pursuant to the Magnuson-Stevens Act, NOAA manages the nation's fisheries with input from eight regional Fishery Management Councils (Councils). The Councils are comprised of representatives from the commercial and recreational fishing sectors, environmental groups, academia, and Federal and State government. Under the Act, the Councils prepare fishery management plans (FMPs) and amendments to FMPs, and they recommend implementing regulations for each managed fishery. With certain exceptions, rulemakings under the Magnuson-Stevens Act are usually recommended by the actions of the Councils. FMPs address a variety of issues, including maximizing fishing opportunities on healthy stocks, rebuilding overfished stocks, and addressing gear conflicts. In turn, after considering the Councils' recommendations in light of the standards and requirements set forth in the Magnuson-Stevens Act and other applicable laws, NOAA (exercising delegated authority) makes decisions on whether to issue regulations to implement the proposed FMPs and FMP amendments. This collaboration with the Councils gives NMFS the flexibility to incorporate local level input to develop management strategies appropriate for each region's unique fisheries, challenges, and opportunities. It also provides for a robust public process. Throughout the Council process, there is significant opportunity for public engagement, including participating on advisory panels, providing testimony at public hearings, and commenting on Council actions. After considering the Councils' recommendations in light of the standards and requirements set forth in the Magnuson-Stevens Act and in other applicable laws, NOAA may issue regulations to implement the proposed FMPs and FMP amendments. As itemized in the Unified Agenda, NOAA plans to take several hundred actions in FY 2026 under Magnuson-Stevens Act authority to achieve optimum yield for our fisheries. ( printed page 52817)

Marine Mammal Protection Act

The Marine Mammal Protection Act of 1972 (MMPA) provides the authority for the conservation and management of marine mammals under U.S. jurisdiction. The MMPA expressly prohibits, with certain exceptions, the intentional take of marine mammals. The MMPA allows, upon request and subsequent authorization, the incidental take of marine mammals by U.S. citizens who engage in a specified activity ( e.g., offshore energy-related activities, scientific research) within a specified geographic region. NMFS authorizes incidental take under the MMPA if it finds that the taking would be of small numbers, have no more than a “negligible impact” on those marine mammal species or stock, and would not have an “unmitigable adverse impact” on the availability of the species or stock for “subsistence” uses. NMFS also initiates rulemakings under the MMPA to establish a management regime to reduce marine mammal mortalities and injuries as a result of interactions with fisheries. In addition, the MMPA allows NMFS to permit the take or import of wild animals for scientific research or public display or to enhance the survival of a species or stock.

Endangered Species Act

The Endangered Species Act of 1973 (ESA) provides for the conservation of species that are determined to be “endangered” or “threatened,” and the conservation of the ecosystems on which these species depend. NMFS and the Department of Interior's Fish and Wildlife Service (FWS) jointly administer the provisions of the ESA: NMFS manages marine and several anadromous species, and FWS manages land and freshwater species. NMFS rulemaking actions under the ESA are focused on determining whether any species under its jurisdictional responsibility is endangered or threatened and whether those species must be added to the List of Threatened and Endangered Species. NMFS is also responsible for designating, reviewing and revising critical habitat for any listed species. One of the agency's priorities under the ESA is a joint action with FWS to rescind the definition of “harm” (0648-BN93). The existing regulatory definition of “harm,” which includes habitat modification, runs contrary to the best meaning of the statutory term “take.” This action will adhere to the single, best meaning of the ESA.

The National Marine Sanctuaries Act

The National Marine Sanctuaries Act (NMSA) authorizes the Secretary of Commerce to designate and protect as national marine sanctuaries areas of the marine environment with special national significance due to their conservation, recreational, ecological, historical, scientific, cultural, archeological, educational, or aesthetic qualities. The primary objective of the NMSA is to protect marine resources, such as coral reefs, sunken historical vessels, or unique habitats.

NOAA's Office of National Marine Sanctuaries (ONMS), within NOS, has the responsibility for management of national marine sanctuaries. Regulations issued pursuant to NMSA describe and define the boundaries of the designated national marine sanctuaries, and set up a system of permits to allow the conduct of certain types of activities that would otherwise not be allowed.

These regulations can, among other things, regulate and restrict activities that may injure natural resources, including all extractive and destructive activities, consistent with community-specific needs and NMSA's purpose to “facilitate to the extent compatible with the primary objective of resource protection, all public and private uses of the resources of these marine areas.” In FY 2025, NOAA published three regulatory actions under NMSA.

Coastal Zone Management Act

The Coastal Zone Management Act (CZMA) was passed in 1972 to preserve, protect, and develop and, where possible, to restore and enhance the resources of the nation's coastal zone. The CZMA creates a voluntary state-federal partnership, where coastal states (States in, or bordering on, the Atlantic, Pacific or Arctic Ocean, the Gulf of America, Long Island Sound, one or more of the Great Lakes, and Pacific and Caribbean U.S. territories and commonwealths), may elect to develop comprehensive programs that meet federal approval standards. Currently, 34 of the 35 eligible entities are implementing a federally approved coastal management plan approved by NOAA.

Of the numerous regulatory actions that NOAA is planning for this year and that are included in the Unified Agenda, the Department describes three below.

NOAA's Regulatory Plan Actions

1. Endangered and Threatened Wildlife and Plants; Regulations for Listing Species and Designating Critical Habitat (0648-BN70): This action responds to the E.O. 14154, titled “Unleashing American Energy,” which directed all departments and agencies to immediately review agency actions that potentially impose an undue burden on the identification, development, or use of domestic energy resources, and, as appropriate and consistent with applicable law, consider suspending, revising, or rescinding agency actions that conflict with this national objective. The Department of Interior (DOI) issued Secretarial Order (SO) 3418 to implement E.O. 14154 and requires that the FWS, in cooperation with NMFS, take action to suspend, revise, or rescind the ESA regulations that were revised in 2024. E.O. 14219 also directs all departments and agencies to review and rescind unlawful regulations that are “based on anything other than the best reading of the underlying statutory authority.”

2. Endangered and Threatened Wildlife and Plants; Interagency Cooperation (0648-BN79): This action responds to the E.O. 14154, titled “Unleashing American Energy,” which directed the removal of impediments imposed on the development and use of the country's energy and natural resources by the previous administration's regulations, and the Department of Interior (DOI) Secretarial Order (SO) 3418, to implement E.O. 14154 which specifically requires that the FWS, in cooperation with the NMFS take action to suspend, revise, or rescind the ESA regulations that were revised in 2024. E.O. 14219 also directs all departments and agencies to review and rescind unlawful regulations that are “based on anything other than the best reading of the underlying statutory authority.”

3. Deep Seabed Mining: Revisions to Regulations for Exploration License and Commercial Recovery Permit Applications (0648-BN96): This action is to revise NOAA's regulations (15 CFR parts 970 and 971) that implement the Deep Seabed Hard Mineral Resources Act, 30 U.S.C. 1401, et. seq., (DSHMRA or the Act). DSHMRA is an important part of the President's directive, E.O. 14285, “Unleashing America's Offshore Critical Minerals and Resources,” to establish policies to advance U.S. leadership in seabed mineral exploration and responsible commercial recovery. Currently, the DSHMRA regulations require a sequential process. Applicants must first obtain an exploration license from NOAA before they can submit a commercial recovery permit application. When NOAA promulgated the DSHMRA regulations in the 1980s, this sequential approach was appropriate due to the nascent stage of deep seabed mining technology and ( printed page 52818) the data needed for a commercial recovery application. However, at that time NOAA reserved a section of the regulations for a consolidated review once the industry matured. See 51 FR 26794, 26796 (July 25, 1986).

The United States Patent and Trademark Office

The USPTO's mission is to foster innovation, competitiveness, and economic growth, domestically and abroad, by delivering high quality and timely examination of patent and trademark applications, guiding domestic and international intellectual property policy, and delivering intellectual property information and education worldwide.

Major Programs and Activities

The USPTO is responsible for granting U.S. patents and registering trademarks. This system of secured property rights, which has its foundation in Article I, Section 8, Clause 8, of the Constitution (providing that Congress shall have the power to “promote the Progress of Science and useful Arts, by securing for limited Times to Authors and Inventors the exclusive Right to their respective Writings and Discoveries”) has enabled American industry to flourish. New products have been invented, new uses for old ones discovered, and employment opportunities created for millions of Americans. The continued demand for patents and trademarks underscores the importance to the U.S. economy of effective mechanisms to protect new ideas and investments in innovation, as well as the ingenuity of American inventors and entrepreneurs.

In addition to granting patents and trademarks, the USPTO advises the President of the United States, the Secretary of Commerce, and U.S. government agencies on intellectual property (IP) policy, protection, and enforcement; and promotes strong and effective IP protection around the world. The USPTO furthers effective IP protection for U.S. innovators and entrepreneurs worldwide by working with other agencies to secure strong IP provisions in free trade and other international agreements. It also provides training, education, and capacity building programs designed to foster respect for IP and encourage the development of strong IP enforcement regimes by U.S. trading partners.

Of the rulemaking actions that the USPTO is planning for this year and that are included in the Unified Agenda, outlined below is the USPTO's most important upcoming regulatory action for this year.

The USPTO's Regulatory Plan Actions

1. Setting and Adjusting Patent Fees (0651-AD88): This final rule would set and adjust Patent fee amounts to provide the Office with sufficient aggregate revenue to recover its aggregate cost of operations thereby maintaining a sustainable funding model.

Bureau of Industry and Security

BIS advances U.S. national security, foreign policy, and economic objectives by administering and enforcing export controls, conducting Section 232 investigations, and performing various other functions to strengthen national security and the defense industrial base.

Major Programs and Activities

BIS administers five sets of regulations.

The Export Administration Regulations (EAR) regulate exports and reexports to protect national security, foreign policy, and short supply interests. The EAR includes the Commerce Control List (CCL), which describes commodities, software, and technology that are subject to licensing requirements for specific reasons for control. The EAR also regulates U.S. persons' participation in certain boycotts administered by foreign governments.
The National Security Industrial Base Regulations (NSIBR) provide for prioritization of certain contracts and allocations of resources to promote the national defense, require reporting of foreign government-imposed offsets in defense sales, provide for surveys to assess the capabilities of the industrial base to support the national defense, and address the effect of imports on the defense industrial base.
The Chemical Weapons Convention Regulations implement declaration, reporting, and on-site inspection requirements in the private sector necessary to meet United States treaty obligations under the Chemical Weapons Convention treaty.
The Additional Protocol Regulations implement similar requirements for certain civil nuclear and nuclear-related items with respect to an agreement between the United States and the International Atomic Energy Agency.
The ICTS Transaction Review Regulations (ICTS-R) are administered by the Office of Information and Communications Technology and Services (OICTS) and implement the authority to prohibit or mitigate any acquisition, importation, transfer, installation, dealing in, or use of any information or communications technology and service (ICTS) that has been designed, developed, manufactured, or supplied by persons owned by, controlled by, or subject to the jurisdiction or direction of foreign adversaries that pose undue or unacceptable risk to the U.S. national security or U.S. persons' safety. The BIS ICTS program reviews and addresses ICTS transactions, including classes of transactions, that pose undue or unacceptable risks in the United States, which involves vetting and prioritizing referrals, compiling intelligence, and other information, conducting investigations into transactions, performing risk-based analysis, and recommending mitigation measures and/or prohibitions to the Secretary of Commerce.

BIS also has an enforcement component with nine offices covering the United States, as well as BIS export control officers stationed at several U.S. embassies and consulates abroad. BIS works with other U.S. Government agencies to promote coordinated U.S. Government efforts in export controls and other programs. BIS participates in U.S. Government efforts to strengthen multilateral export control regimes and promote effective export controls through cooperation with other governments.

In FY 2026, BIS plans to publish a number of proposed and final rules amending the EAR. These rules will cover a range of issues, including EAR controls for artificial intelligence and Unmanned Aircraft Systems. BIS also continues to identify and propose controls for emerging and foundational technologies. BIS also plans to publish proposed and final rules amending the NSIBR, including establishing a Copper Tariffs Inclusions Process for including additional derivative copper articles within the scope of the ad valorem duties as authorized by the President under Section 232 of the Trade Expansion Act of 1962, as amended (Section 232).

Outlined below are BIS's most important upcoming regulatory actions for this year.

BIS's Regulatory Plan Actions

1. Implementation of the AI Action Plan Through Export Controls (RIN 0694-AJ90): This interim final rule (IFR) will formally rescind the “Framework for Artificial Intelligence Diffusion ” rule issued by the Biden Administration in January 2025—which BIS has already stopped enforcing. The IFR will also establish a new, streamlined framework to enable the secure spread of U.S. technology around the globe consistent ( printed page 52819) with U.S. national security and foreign policy objectives.

2. Copper Tariffs Inclusions Process (RIN 0694-AK36): Establishes a process for including additional derivative copper articles within the scope of the ad valorem duties authorized by the President under Section 232 of the Trade Expansion Act of 1962, as amended (Section 232).

3. Unmanned Aircraft Systems (0694-AJ72): This rule will reduce export controls on drones exported to certain U.S. partners and allies.

DOC—National Oceanic and Atmospheric Administration (NOAA)	Proposed Rule Stage

19. ENDANGERED AND THREATENED WILDLIFE AND PLANTS; REGULATIONS FOR LISTING SPECIES AND DESIGNATING CRITICAL HABITAT

Priority: Other Significant

Regulatory Accounting: Deregulatory

Legal Authority: 16 U.S.C. 1531 et seq.

Relevant Executive Orders: 14154; 14219

CFR Citation: 50 CFR 424

Legal Deadline: None

Abstract: This is a joint rulemaking with the Department of the Interior to rescind or revise regulations in 50 CFR part 424 that were promulgated in 2024 regarding classification of species and the designation of critical habitat under the Endangered Species Act.

Statement of Need: This action responds to the Executive Order (E.O.) 14154, titled “Unleashing American Energy,” which directed all departments and agencies to immediately review agency actions that potentially impose an undue burden on the identification, development, or use of domestic energy resources, and, as appropriate and consistent with applicable law, consider suspending, revising, or rescinding agency actions that conflict with this national objective. The Department of Interior (DOI) issued Secretarial Order (SO) 3418 to implement E.O. 14154 and requires that the U.S. Fish and Wildlife Service (USFWS), in cooperation with National Marine Fisheries Service (NMFS), take action to suspend, revise, or rescind the Endangered Species Act (ESA) regulations that were revised in 2024. E.O. 14219 also directs all departments and agencies to review and rescind unlawful regulations that are “based on anything other than the best reading of the underlying statutory authority.”

Summary of Legal Basis: This action is authorized under 16 U.S.C. 1531 et seq.

Alternatives: This is a joint rulemaking by NMFS and USFWS (collectively referred to as the Services) to amend portions of the regulations in 50 CFR 424 that implement section 4 of the Endangered Species Act of 1973, as amended. A final rule revising these same regulations in 50 CFR 424 was published on April 5, 2024, and became effective on May 6, 2024 (89 FR 24300). Based on a review of the 2024 rule in response to E.O. 14154, E.O. 14219, and DOI Secretarial Order 3418, the Services are proposing to revise the regulations that were addressed in the 2024 final rule. The regulations proposed in this rule would provide criteria or otherwise clarify the processes by which the Services will interpret and implement various statutory requirements set forth in section 4 of the Act. Prior to developing and issuing a final rule, the Services will review and consider public comments received.

Anticipated Cost and Benefits: This proposed rule would revise and clarify requirements for the Services in classifying species and designating critical habitat under the ESA. The proposed regulations would not expand the reach of species protections or designations of critical habitat. NMFS and FWS are the only entities that would be directly affected by this rule, because they are the only entities that list species or designate critical habitat. No external entities, including any small businesses, small organizations, or small governments, will experience any direct economic impacts from this proposed rule. Anticipated benefits of this regulatory revisions include increased clarity in implementing section 4 of the ESA.

Risks: This action is expected to receive a significant amount of public comment from a diverse set of interested parties. The 2024 rule is also subject to ongoing litigation.

Timetable:

Action	Date	FR Cite
NPRM	11/21/25	90 FR 52607
NPRM Comment Period End	12/22/25

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: Federal

Agency Contact: Kim Damon-Randall, Director, Office of Protected Resources, Department of Commerce, National Oceanic and Atmospheric Administration, 1315 East-West Highway, Silver Spring, MD 20910

Phone: 301 427-8400

Email: kimberly.damon-randall@noaa.gov

RIN: 0648-BN70

DOC—NOAA	Final Rule Stage

20. ENDANGERED AND THREATENED WILDLIFE AND PLANTS; INTERAGENCY COOPERATION REGULATIONS

Priority: Other Significant

Regulatory Accounting: Not subject to, not significant

Legal Authority: 16 U.S.C. 1531 et seq.

Relevant Executive Orders: 14154; 14219

CFR Citation: 50 CFR 402

Legal Deadline: None

Abstract: The National Marine Fisheries Service and U.S. Fish and Wildlife Service (collectively referred to as the Services) propose to amend portions of our regulations that implement section 7 of the Endangered Species Act of 1973, as amended. A final rule revising the Endangered Species Act (ESA) Interagency Cooperation Regulations at 50 CFR 402 was published on April 5, 2024, and became effective on May 6, 2024. Pursuant to a review of this rule under E.O. 14154 and DOI Secretarial Order 3418, the Services are proposing to revise provisions of the 2024 final rule (89 FR 24268). The resulting rulemaking action will clarify, interpret, and implement portions of section 7 of the ESA concerning interagency cooperation procedures. This rulemaking would revise existing procedures for federal agencies, including the Services under section 7 of the ESA. Federal agencies would be the only entities directly affected by this rulemaking.

Statement of Need: This action responds to the Executive Order (E.O.) 14154, titled “Unleashing American Energy,” which directed the removal of impediments imposed on the development and use of the country's energy and natural resources by the previous administration's regulations, and the Department of Interior (DOI) Secretarial Order (SO) 3418, to implement E.O. 14154 which specifically requires that the U.S. Fish and Wildlife Service (USFWS), in cooperation with the National Marine Fisheries Service (NMFS) take action to suspend, revise, or rescind the ESA regulations that were revised in 2024. E.O. 14219 also directs all departments and agencies to review and rescind unlawful regulations that are “based on anything other than the best reading of the underlying statutory authority.” ( printed page 52820)

Summary of Legal Basis: This action is authorized under 16 U.S.C. 1531 et seq.

Alternatives: This is a joint rulemaking by NMFS and USFWS (collectively referred to as the Services) to amend portions of our regulations that implement section 7 of the Endangered Species Act of 1973, as amended. A final rule revising the Endangered Species Act (ESA) Interagency Cooperation Regulations at 50 CFR 402 was published on April 5, 2024, and became effective on May 6, 2024. Pursuant to a review of this rule under E.O.14154, E.O. 14219, and DOI Secretarial Order 3418, the Services are proposing to revise provisions of the 2024 final rule (89 FR 24268). The resulting rulemaking action will revise, interpret, and implement portions of section 7 of the ESA concerning interagency cooperation procedures. This rulemaking would revise existing procedures for Federal agencies, including the Services under section 7 of the ESA. Prior to developing and issuing a final rule, the Services will review and consider public comments received.

Anticipated Cost and Benefits: The rulemaking revises existing requirements for Federal agencies, including the Services, under section 7 of the ESA. Federal agencies are the only entities affected by this rule. We do not anticipate significant costs associated with the rule. This rule is intended to revise the standards with which we evaluate proposed Federal agency actions pursuant to section 7 of the ESA.

Risks: This action addresses the ESA Interagency Cooperation provisions in the Services' joint ESA implementing regulations. This action will receive a significant level of scrutiny and attention by a diverse set of constituents. The 2024 rule is subject to ongoing litigation and this rulemaking may influence that process. Overall, the proposed changes will reduce the risk to ESA-listed species and designated critical habitat associated with ensuring Federal action agencies do not jeopardize the continued existence of listed species or destroy or adversely modify designated critical habitat and continue to provide for the conservation of ESA resources.

Timetable:

Action	Date	FR Cite
NPRM	11/21/25	90 FR 52600
NPRM Comment Period End	12/22/25

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: Federal

Agency Contact: Kim Damon-Randall, Director, Office of Protected Resources, Department of Commerce, National Oceanic and Atmospheric Administration, 1315 East-West Highway, Silver Spring, MD 20910

Phone: 301 427-8400

Email: kimberly.damon-randall@noaa.gov

RIN: 0648-BN79

DOC—Patent and Trademark Office (PTO)	Proposed Rule Stage

21. SETTING AND ADJUSTING PATENT FEES

Priority: Other Significant. Major under 5 U.S.C. 801.

Regulatory Accounting: Fully or Partially Exempt

Legal Authority: Pub. L. 112-29

CFR Citation: 37 CFR 1; 37 CFR 41; 37 CFR 42

Legal Deadline: None

Abstract: The United States Patent and Trademark Office (USPTO or Office) takes this action to set and adjust Patent fee amounts to provide the Office with sufficient aggregate revenue to recover its aggregate cost of operations thereby maintaining a sustainable funding model.

Statement of Need: The purpose of this rule is to set and adjust patent fee amounts to modernize the patent fee structure. To this end, this rule may create new or change existing fees for patent services.

Summary of Legal Basis: The Leahy-Smith America Invents Act (AIA), enacted in 2011, provided USPTO with the authority to set and adjust its fees for patent and trademark services. Since then, USPTO has conducted an internal biennial fee review, in which it undertook internal consideration of the current fee structure, and considered ways that the structure might be improved, including rulemaking pursuant to the USPTO's fee setting authority. This fee review process involves public outreach, including, as required by the Act, public hearings held by the USPTO's Public Advisory Committees, as well as public comment and other outreach to the user community and public in general.

Alternatives: This rulemaking action is currently in development and alternatives have not yet been determined.

Anticipated Cost and Benefits: This rulemaking action is currently in development and aggregate annual economic impacts have not yet been determined.

Risks: This rulemaking action is currently in development and risks have not yet been determined.

Timetable:

Action	Date	FR Cite
NPRM	07/00/26
NPRM Comment Period End	09/00/26
Final Action	07/00/26
Final Action Effective	05/00/27

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses, Organizations

Government Levels Affected: None

International Impacts: This regulatory action will be likely to have international trade and investment effects, or otherwise be of international interest.

Agency Contact: C. Brett Lockard, Director, Forecasting and Analysis, Department of Commerce, Patent and Trademark Office, P.O. Box 1450, Alexandria, VA 22313-1450

Phone: 571 272-0928

Email: christopher.lockard@uspto.gov

RIN: 0651-AD88

BILLING CODE 3410-12-P

Department Of War

Statement of Regulatory Priorities

Background

The Department of War (DoW) is the largest Federal department, employing over 2.8 million people (including 1,326,211 active duty military personnel; 767,774 Reserve/Guard; and 770,132 Appropriated Funds civilian positions) with operations all over the world. DoW's enduring mission is to provide combat-credible military forces needed to protect the security of our nation. To guide this mission, the Secretary of War has outlined three top priorities, which are to revive the warrior ethos, rebuild our military, and reestablish deterrence. Because of this expansive and diversified mission and reach, DoW regulations can address a broad range of matters and have an impact on varied members of the public, as well as other Federal agencies.

Pursuant to Executive Order 12866, “Regulatory Planning and Review” (September 30, 1993) and Executive Order 13563, “Improving Regulation and Regulatory Review” (January 18, 2011), the DoW issues this Regulatory Plan and Agenda to provide notice about the DoW's regulatory and ( printed page 52821) deregulatory actions. Consistent with current Administration policy, the Department places primary emphasis on deregulatory actions and regulatory restraint. Regulatory actions are advanced only where required by statue, necessary to implement higher-level policy direction, or essential to national security and mission execution.

Deregulatory Policy and Compliance

In accordance with Executive Order 14192, the DoW evaluates all existing and proposed regulatory actions to identify opportunities to reduce regulatory burden, eliminate unnecessary or duplicative requirements, and achieve measurable cost savings.

The Department requires Components to demonstrate Executive Order 14192 compliance for any regulatory action proposed for inclusion in the Unified Agenda. This includes identification of deregulatory actions or offsets, documentation of anticipated cost savings or burden reductions, and confirmation that the action does not exceed Administration-wide cost caps. Actions that do not meet Executive Order 14192 criteria are not prioritized and may be deferred or withdrawn.

Deregulatory Governance and Oversight

The DoW maintains centralized oversight of deregulatory actions through its regulatory governance framework. Proposed actions are reviewed for Executive order compliance, cost impacts, and alignment with the Secretary's priorities prior to submission to the Office of Management and Budget. This oversight ensures consistent application of deregulatory policy across all Components and supports defensible, date-driven decision-making.

Retrospective Review of Existing Regulations Under Executive Order 14219, “Ensuring Lawful Governance and Implementing the President's “Department of Government Efficiency” Deregulatory Initiative” (February 19, 2025), the Department conducts coordinated, Department-wide reviews to identify regulations suitable for repeal, consolidation, or modification. These reviews focus on reducing compliance burden, improving clarity, and enhancing operational flexibility while maintaining statutory and national security requirements.

Pursuant to section 6 of Executive Order 13563, “Improving Regulation and Regulatory Review” (January 18, 2011), the Department continues to review existing regulations with a goal to eliminate outdated, unnecessary, or ineffective regulations; account for the currency and legitimacy of each of the Department's regulations; and ultimately reduce regulatory burden and costs.

Public Participation and Community Outreach

As the DoW develops our regulations, we seek to increase public participation and community outreach to be better informed of and address issues from members of the public affected by our regulations. The following provides examples of our specific outreach and public participation efforts. The Office of the Assistant to the Secretary of War for Public Affairs/Community Engagement Directorate, via its Opinion Leader Engagement portfolio, provides public affairs support to leaders throughout the Office of the Secretary of War (OSW) who are responsible for regulatory activities. This support includes convening roundtables and similar engagements for national stakeholder organizations to meet with OSW leaders to discuss and share information about DoW policies and programs that are governed by Federal regulations. For example, regular engagements with leaders of national military and veteran supporting organizations include topics such as military benefits, housing, healthcare, compensation, and sexual assault prevention and response, which are governed by law and Federal regulation. These meetings allow the regulating authorities in OSW an opportunity to dialogue with national organizations with a stakeholder interest in the impact and effect of DoW regulations.

DoW engages with the public on procurement-related regulations that will affect the Defense Federal Acquisition Regulation Supplement (DFARS) in several ways. In addition to publishing abstracts of and anticipated publication dates for upcoming rules in the biannual Unified Agenda, members of the public can track the progress of any open and pending DFARS regulation via the Open DFARS Cases Report, which is publicly available at www.acq.osd.mil/dpap/dars/case_status.html. The report is updated on a weekly basis and includes the following information: a case number, title, DFARS parts anticipated to be impacted by the regulation, a summary of the basis for the regulation, and the status of the regulation. Members of the public who are interested in a particular DFARS case are encouraged to monitor the Open DFARS Cases Report to track the progress of a particular regulation through the rulemaking process.

DoW also meets with industry associations on a quarterly basis. Industry associations that regularly participate in these quarterly discussions include the Council of Defense and Space Industry Associations, the Professional Services Council, the Aerospace Industries Association, and the National Defense Industrial Association. During these meetings, DoW often provides updates on open DFARS cases.

While developing certain DFARS regulations, DoW may seek input from the public by publishing in the Federal Register an early engagement opportunity, an advance notice of proposed rulemaking (ANPR), or a general request for information (RFI). Notices for early engagement opportunities usually pertain to a recent law, such as the annual National Defense Authorization Act (NDAA), and request input on implementation of the law in the DFARS. ANPRs and RFIs may include a summary of the overarching policy objectives of the regulation and a list of questions seeking input that will help DoW develop a proposed regulation. Information on whether DoW plans to publish an ANPR or RFI is included in both the Open DFARS Cases Report and the biannual Unified Agenda.

Occasionally, while an ANPR, proposed DFARS regulation, or interim DFARS regulation is out for public comment, DoW may hold a public meeting to allow the public to provide feedback to the Government in an open forum. Information about whether DoW plans on holding a public meeting for an ANPR or a regulation is normally included in the ANPR, proposed regulation, or interim regulation when it is published for public comment. Presentations made during the public meeting are made publicly available.

The U.S. Army Corps of Engineers (USACE) occasionally utilizes listening sessions prior to proposing a rule to obtain public input that is then used to inform the contents of the proposed rule. Additionally, Federal Register notices, website postings, press releases, and social media releases are used to notify the public of the dates and times for the listening sessions. When a Federal Register notice is used to provide notification of the listening sessions, the use of an open docket is employed for the submission of public comments in addition to the receipt of public comments during the listening sessions.

Also, the USACE may publish an ANPR to engage the public on the development of a proposed rule. Federal Register notices, website postings, press releases, and social media releases are used to notify the ( printed page 52822) public of the publication of the proposed rule and how they can provide comments and engage in the rulemaking effort.

Finally, the USACE has meetings with industry associations, non-Government Organizations (NGOs), or similar stakeholders to provide updates on proposed policies or actions to solicit informal feedback that is used to help inform the path forward for the development of a proposed rule.

DoW Priority Deregulatory Actions

The Federal regulatory and deregulatory actions identified in this Regulatory Plan embody the core of DoW's regulatory priorities for Fiscal Year (FY) 2026 and help support the President's regulatory priorities, the Secretary of War's top priorities. The DoW Deregulatory prioritization is focused on initiatives that:

Restore the warrior ethos.
Rebuild our military readiness and capability;
Reestablish credible deterrence; and.
Strengthen national security, including safeguarding Federal information and information technology systems.

Rules That Promote the Country's Economic Resilience

Solicitation Provisions and Contract Clauses. RIN 0790-AK52

This final rule amends the Defense Logistics Agency (DLA) acquisition regulations in title 48 Code of Federal Regulations (CFR) part 5452 by removing an unnecessary clause. The 5452.249 Allocation clause became effective on May 4, 1995, and was last revised on May 17, 2001 (66 FR 27474). The rule permits fuel contractors to supply less than the full amount of fuel contracted for by the government, without being terminated for default, during periods of exceptional fuel shortages, provided that the fuel shortage is beyond the control and without the fault or negligence of the contractor. The DLA has determined there are existing Federal Acquisition Regulations and DFARS clauses on excusable delay.

Reissuance and Modification of Nationwide Permits. 0710-AB56

This proposed rule would begin the process of reissuing the 57 existing nationwide permits before they expire on March 14, 2026. Under the Clean Water Act and the Corps' regulations, nationwide permits can be issued for a period of no more than five years. If the nationwide permits are not reissued before they expire, they automatically become null and void and project proponents who want to conduct activities regulated under section 404 of the Clean Water Act or section 10 of the Rivers and Harbors Act would need to obtain individual permits from the Corps for those activities. The nationwide permits are a type of general permit issued by the Chief of Engineers and are designed to regulate with little, if any, delay or paperwork categories of activities having no more than minimal individual and cumulative adverse environmental impacts. The nationwide permits provide environmental protection by incentivizing project proponents to reduce impacts to waters and wetlands to obtain the required Corps authorization in less time than it would take to be granted individual permits for regulated activities.

Updated Definition of “Waters of the United States”. 0710-AB59

The Environmental Protection Agency and the Department of the Army are undertaking a rulemaking to revise key topics of the waters of the United States definition in light of the Supreme Court's decision in Sackett v. Environmental Protection Agency, 598 U.S. 651 (2023), including continuous surface connection, relatively permanent, and jurisdictional versus non-jurisdictional ditches. These revisions focus on clarity, simplicity, and improvements that will stand the test of time. This action will streamline implementation of Clean Water Act programs by aligning the definition of waters of the United States with Sackett, which significantly narrowed the definition under the Clean Water Act.

Health Care Priorities

TRICARE Removal of Temporary Regulation Change and Freestanding End-Stage Renal Disease (ESRD) Facilities as TRICARE-Authorized Institutional Providers and Reimbursement Methods for ESRD Facilities. RIN 0720-AB85

This rule finalizes an interim final rule that amended 32 CFR part 199 by: (1) adding freestanding End Stage Renal Disease (ESRD) facilities as a category of TRICARE-authorized institutional provider and modifying the reimbursement for such facilities; and (2) temporarily adopting Medicare's New COVID-19 Treatments Add-on Payment (NCTAP). The ESRD provisions are made permanent, and the temporary NCTAP provisions which expired at the end of the public health emergency are terminated.

Medical Billing for Healthcare Services Provided by Department of War Medical Treatment Facilities to Civilian Non-Beneficiaries. RIN 0720-AB87

This final rule is aimed at preventing severe financial harm to civilians who are not covered beneficiaries of the Military Health System, and who receive healthcare services at military medical treatment facilities. The proposed rule implements the requirement to apply a sliding fee and/or a catastrophic waiver to medical invoices of non-beneficiaries; to accept payments from health insurers as full payment; to not balance bill non-beneficiaries except for copays, coinsurance, deductibles, nominal fees, and non-covered services; and grants the Director of Defense Health Agency (DHA) discretionary authority to waive medical debts of non-beneficiaries when the healthcare provided enhances the knowledge, skills, and abilities of healthcare providers, as determined by the Director of DHA.

Rules That Support National Security Efforts

Cybersecurity Maturity Model Certification (CMMC) Program. RIN 0790-AM01

With this amendment, DoW amends the CMMC Program to comply with National Institute of Standards and Technology (NIST) Special Publication (SP) 800-171 Revision 2, to a requirement to comply with NIST SP 800-171 Revision 3. As described by NIST, the significant changes between these two documents include added specificity in the security requirements and introduction of organization-defined parameters (ODPs) in select security requirementsIn addition to revising documents incorporated by reference in this rule, this amendment adds administrative edits and clarifying content in certain areas.

National Industrial Security Program Operating Manual (NISPOM); Second Amendment. RIN 0790-AL52

The DoW is amending the NISPOM based on public comments received on a final rule published on December 21, 2020. The amendments address implementation guidance and costs for the Security Executive Agent Directive (SEAD) 3; clarifications on procedures for the protection and reproduction of classified information and controlled unclassified information (CUI); National Interest Determination (NID) requirements for cleared contractors operating under a Special Security Agreement for Foreign Ownership, Control or Influence; and eligibility ( printed page 52823) determinations for personnel security clearance processes and requirements.

DOW—Office of the Secretary (OS)	Final Rule Stage

22. SOLICITATION PROVISIONS AND CONTRACT CLAUSES

Priority: Other Significant

Regulatory Accounting: Deregulatory

Legal Authority: 5 U.S.C. 301

CFR Citation: 48 CFR 5452

Legal Deadline: None

Abstract: This final rule amends the Defense Logistics Agency (DLA) acquisition regulations in 48 CFR part 5452 by removing an unnecessary clause. The 5452.249 Allocation clause became effective on May 4, 1995, and was last revised on May 17, 2001 (66 FR 27474). The rule permits fuel contractors to supply less than the full amount of fuel contracted for by the government, without being terminated for default, during periods of exceptional fuel shortages, provided that the fuel shortage is beyond the control and without the fault or negligence of the contractor. The DLA has determined there are existing Federal Acquisition Regulations (FAR) and Defense Federal Acquisition Regulation Supplements (DFARS) clauses on excusable delay.

Statement of Need: This final rule amends the DLA acquisition regulations in this part by removing an unnecessary clause. The Allocation clause was effective on May 4, 1995, and permitted fuel contractors to supply less than the full amount of fuel contracted for by the government, without being terminated for default, during periods of exceptional fuel shortages, provided that the fuel shortage is beyond the control and without the fault or negligence of the contractor. DLA has determined that this clause is not necessary, since there are means to address the circumstance described under existing Federal Acquisition Regulation and Defense Federal Acquisition Regulation Supplement clauses on excusable delay. Therefore, the clause may be removed.

Summary of Legal Basis: 5 U.S.C. 301

Alternatives: None

Anticipated Cost and Benefits: The rule removes a clause that is no longer in use. Therefore, there is no impact on contractors or offerors. This rule removal will not create any costs.

Risks: None

Timetable:

Action	Date	FR Cite
Final Action	07/00/26

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Tracie Swann,

Department of War, Office of the Secretary, 8752 John J Kingman Rd, Ste 2545, Fort Belvoir, VA 22060.

Phone: 571 767-1124

Email: tracie.swann@dla.mil

RIN: 0790-AK52

DOW—OS	Final Rule Stage

23. NATIONAL INDUSTRIAL SECURITY PROGRAM OPERATING MANUAL (NISPOM); SECOND AMENDMENT

Priority: Other Significant

Regulatory Accounting: Regulatory

Legal Authority: 32 CFR 2004; E.O. 10865; E.O. 12333; E.O. 12829; E.O. 12866; E.O. 12968; E.O. 13526; E.O. 13563; E.O. 13587; E.O. 13691; Pub. L 108-458; 42 U.S.C. 2011 et seq.;50 U.S.C. ch. 44; 50 U.S.C. 3501 et seq.

CFR Citation: 32 CFR 117

Legal Deadline: None

Abstract: The Department of Defense is amending the National Industrial Security Program Operating Manual (NISPOM) based on public comments received on a final rule published on December 21, 2020. The amendments address implementation guidance and costs for the Security Executive Agent Directive (SEAD) 3, clarifications on procedures for the protection and reproduction of classified information, controlled unclassified information (CUI), National Interest Determination (NID) requirements for cleared contractors operating under a Special Security Agreement for Foreign Ownership, Control or Influence, and eligibility determinations for personnel security clearance processes and requirements.

Statement of Need: With this amendment, DoD amends the National Industrial Security Program Operating Manual (NISPOM) to address implementation guidance and costs for the Security Executive Agent Directive (SEAD) 2, clarifications on procedures for the protection and reproduction of classified information.

Summary of Legal Basis: 32 CFR 2004; E.O. 10865; E.O. 12333 ; E.O. 12829 ; E.O. 12866 ; E.O. 12968 ; E.O. 13526 ; E.O. 13563 ; E.O. 13587 ; E.O. 13691 ; Pub. L 108-458 ; 42 U.S.C. 2011 et seq.; 50 U.S.C. ch. 44 ; 50 U.S.C. 3501 et seq.

Alternatives: None

Anticipated Cost and Benefits: DCSA began the cost analysis for the baseline costs for fiscal year (FY) 2017 by randomly selecting active NISP contractor facilities that have existing DoD approval for classified storage at their own physical locations and having those facilities submit security costs. The randomly selected contractor facilities also have an active facility security clearance and a permanent Commercial and Government Entity (CAGE) Code. In addition to the randomly selected cleared facilities having approved classified storage, DCSA categorizes these contractor facilities for the survey based on the size, scope, and complexity of each contractor's security program. The general methodology used to estimate security costs incurred by contractor cleared facilities with approved storage of classified information is based on the costs incurred by respondent contractors for the protection of classified information. The methodology captures the most significant portion of industry's costs, which is labor. Security labor in the survey is defined as personnel whose positions exist to support operations and staff in the implementation of government security requirements for the protection of classified information. Guards who are required as supplemental controls are included in security labor. The respondent contractors are requested to compile their cleared facility's current annual security labor cost in burdened, current year dollars with the most recent data being from the 2017 survey. The labor cost, when identified as an estimated percent of each contractor's total security costs, enables the respondent contractors to calculate their total security costs. Information collected is compiled to create an aggregate estimated cost of NISP classification-related activities.

Risks: None

Timetable:

Action	Date	FR Cite
NPRM	12/13/23	88 FR 86288
NPRM Comment Period End	02/12/24
Final Action	07/00/26

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Allyson C. Renzella,

Industrial Security Specialist, Department of War, Office of the Secretary, 1400 Defense Pentagon, Arlington, VA 20130.

Phone: 703 697-9209

Email: allyson.c.renzella.civ@mail.mil

Related RIN:

Related to 0790-AK85, Related to 0790-AL41 ( printed page 52824)

RIN: 0790-AL52

DOW—OS	Final Rule Stage

24. • CYBERSECURITY MATURITY MODEL CERTIFICATION (CMMC) PROGRAM

Priority: Other Significant. Major status under 5 U.S.C. 801 is undetermined.

Regulatory Accounting: Fully or Partially Exempt

Legal Authority: 5 U.S.C. 301; Pub. L. 116-92, sec. 1648; 133 Stat. 1198

CFR Citation: 32 CFR 170

Legal Deadline: None

Abstract: This amendment defines a deadline and period for transition from the requirement to comply with NIST SP 800-171 Revision 2, to a requirement to comply with NIST SP 800-171 Revision 3. Significant changes between these two documents include added specificity in the security requirements and introduction of organization-defined parameters (ODP) in select security requirements. In addition to revising the NIST documents that are incorporated by reference in 32 CFR part 170, this amendment adds administrative edits and clarifying content in multiple areas as necessary to effect the transition.

Statement of Need: With this amendment, DoD amends the Cybersecurity Maturity Model Certification (CMMC) Program to define a period for transition from the requirement to comply with NIST SP 800-171 Revision 2, to a requirement to comply with NIST SP 800-171 Revision 3. As described by NIST, the significant changes between these two documents include added specificity in the security requirements and introduction of organization-defined parameters (ODPs) in select security requirements. In addition to revising documents incorporated by reference in this rule, this amendment adds administrative edits and clarifying content in multiple areas.

Summary of Legal Basis: 5 U.S.C. 301; Sec. 1648, Pub. L. 116-92, 133 Stat. 1198.

Alternatives: None

Anticipated Cost and Benefits: In addition to the change from NIST SP 800-171 revision 2 to revision 3, which impacted CMMC Level 2 and Level 3 assessment objectives, this rule amendment is based on a more current estimate of the size of the Defense Industrial Base. Overall, we estimate approximately 20% fewer total companies will be impacted by 32 CFR part 170.

Risks: None

Timetable:

Action	Date	FR Cite
Interim Final Rule	07/00/26

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses, Governmental Jurisdictions, Organizations

Government Levels Affected: Undetermined

Agency Contact: Carrie Cardwell, Acquisition Analyst, Office of the DoD CIO, Department of War, Office of the Secretary, 4800 Mark Center Drive, Suite 11G14, Alexandria, VA 22350

Phone: 571 372-4410

Email: carrie.m.cardwell.civ@mail.mil

RIN: 0790-AM01

DOW—U.S. Army Corps of Engineers (COE)	PROPOSED RULE STAGE

25. UPDATED DEFINITION OF “WATERS OF THE UNITED STATES”

Priority: Other Significant. Major status under 5 U.S.C. 801 is undetermined.

Regulatory Accounting: Deregulatory

Unfunded Mandates: Undetermined

Legal Authority: 33 U.S.C. 1344 ; 33 U.S.C. 1251

CFR Citation: 33 CFR 328

Legal Deadline: None

Abstract: The EPA and the Department of the Army are undertaking a rulemaking to revise key topics of the waters of the United States definition in light of the Supreme Court's decision in Sackett v. Environmental Protection Agency, 598 U.S. 651 (2023), including continuous surface connection, relatively permanent, and jurisdictional versus non-jurisdictional ditches. These revisions focus on clarity, simplicity, and improvements that will stand the test of time.

Statement of Need: The Environmental Protection Agency and the Department of the Army are undertaking a rulemaking to revise key topics of the waters of the United States definition in light of the Supreme Court's decision in Sackett v. Environmental Protection Agency, 598 U.S. 651 (2023), including continuous surface connection, relatively permanent, and jurisdictional versus non-jurisdictional ditches. These revisions focus on clarity, simplicity, and improvements that will stand the test of time. This action will streamline implementation of Clean Water Act programs by aligning the definition of waters of the United States with Sackett, which significantly narrowed the definition under the Clean Water Act.

Summary of Legal Basis: The Clean Water Act (33 U.S.C. 1251 et seq.)

Alternatives: The EPA and the Army are evaluating alternatives for this action.

Anticipated Cost and Benefits: The EPA and Army are evaluating the anticipated costs and benefits of this action.

Risks: The EPA and the Army are evaluating the risks associated with this action.

Timetable:

Action	Date	FR Cite
NPRM	07/00/26
Final Action	07/00/26

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: Federal, Local, State, Tribal

Federalism: Undetermined

Agency Contact: Elliott Carman, Department of War, 108 Army Pentagon, Room 3E419, Washington, DC 20310-0108,

Phone: 703 300-2899

Email: elliott.n.carman.civ@army.mil

RIN: 0710-AB59

DOW—Office of Assistant Secretary for Health Affairs (DODOASHA)	Final Rule Stage

26. TRICARE REMOVAL OF TEMPORARY REGULATION CHANGE AND FREESTANDING END-STAGE RENAL DISEASE (ESRD) FACILITIES AS TRICARE-AUTHORIZED INSTITUTIONAL PROVIDERS AND REIMBURSEMENT METHODS FOR ESRD FACILITIES

Priority: Other Significant

Regulatory Accounting: Fully or Partially Exempt

Legal Authority: 5 U.S.C. 301; 10 U.S.C. ch. 55

CFR Citation: 32 CFR 199

Legal Deadline: None

Abstract: This rule finalizes the provisions of the interim final rule (88 FR 1992) that added freestanding End-Stage Renal Disease (ESRD) facilities as TRICARE-authorized institutional providers and established reimbursement methodologies for such facilities. These ESRD provisions are adopted as final without substantive change. This rule also removed expired regulatory text related to Medicare's New COVID-19 Treatments Add-on Payment (NCTAP), which was implemented on a temporary basis in the interim final rule and expired at the ( printed page 52825) conclusion of the COVID 19 public health emergency. This removal is administrative in nature and ensures the regulations reflects current policy.

Statement of Need: The modifications to paragraphs 199.6(b)(4)(xxi) and 199.14(a)(1)(iii)(E)( 7) establish freestanding End Stage Renal Disease (ESRD) facilities as a category of TRICARE-authorized institutional provider and modify TRICARE reimbursement of freestanding ESRD facilities. These provisions will improve TRICARE beneficiary access to medically necessary dialysis and other ESRD services and supplies. These provisions also support the requirement that TRICARE reimburse like Medicare, and will help ensure access to dialysis care in freestanding ESRD facilities rather than hospital outpatient departments.

Summary of Legal Basis: This rule is issued under 10 U.S.C. 1073(a)(2) giving authority and responsibility to the Secretary of Defense to administer the TRICARE program.

Alternatives:

(1) No action

(2) The second alternative the Department of Defense considered was to adopt Medicare's ESRD reimbursement methodology, the ESRD Prospective Payment System (PPS), in total. While this would have been completely consistent with the statutory provision to pay institutional providers using the same reimbursement methodology as Medicare, this alternative is not preferred because there is still a relatively low volume of TRICARE beneficiaries who receive dialysis services from freestanding ESRDs and who are not enrolled to Medicare. The cost of implementing the full ESRD PPS system is estimated to be at least $600,000.00 in start-up costs, plus ongoing administrative costs, to ensure all adjustments were made for each claim, plus additional special pricing software or algorithms. In contrast, we estimate that the option provided in this IFR can be implemented relatively quickly (within six months of publication), and for approximately $300,000.00 in start-up costs with lower ongoing administrative costs. Further, the flat rate will provide the ESRD facilities with predictability with regard to TRICARE payments and will reduce uncertainty and specialized coding or case-mix documentation requirements that may be required by the ESRD PPS, reducing the administrative burden on the provider.

To summarize, adopting the ESRD PPS was considered, but was deemed impracticable and overly burdensome to both the Government and providers due to the relative low volume of claims that will be priced and paid by TRICARE as primary under this system.

Anticipated Cost and Benefits: The ESRD provisions are expected to result in $5M in incremental annual health care costs.

Risks: None. This rule will promote the efficient functioning of the economy and markets by modifying the regulations to better reimburse health care providers for particularly as strain on the health care economy is being felt due to reductions in higher cost elective procedures.

Timetable:

Action	Date	FR Cite
Interim Final Rule	01/12/23	88 FR 1992
Interim Final Rule Effective	01/12/23
Interim Final Rule Comment Period End	03/13/23
Final Action	07/00/26

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Duncan Moskowitz, Health Care Program Specialist (Reimbursement), Health Plan Design Division, TRICARE Health Plan, Department of War, Office of Assistant Secretary for Health Affairs, 16401 E Centretech Pkwy, Aurora, CO 80011-9066.

Phone: 303 676-3582

Email: duncan.p.moskowitz.civ@health.mil

RIN: 0720-AB85

BILLING CODE 5001-06-P

DEPARTMENT OF EDUCATION

Statement of Regulatory Priorities

I. Introduction

The U.S. Department of Education (Department) provides financial assistance pertaining to education and related services at all levels to a wide range of stakeholders and individuals, including State educational and other agencies, local school districts, providers of early learning programs, elementary and secondary schools, institutions of higher education, career and technical schools, students, and families.

The Department also vigorously monitors and enforces the implementation of Federal civil rights laws in educational programs and activities that receive Federal financial assistance from the Department. The Department's regulatory priorities aim to return education to the states by promoting as much choice, freedom, and flexibility as possible while ensuring students learn in an environment that promotes educational excellence, not divisive ideologies.

The Department is focused on removing regulatory barriers that impede competition, individual initiative, innovation, and economic growth. This regulatory agenda establishes the Department's regulatory and deregulatory priorities.

II. Public Participation

We invite the public to submit comments on all proposed regulations through the internet or by regular mail. We also note that the Higher Education Act of 1965 requires the Department to use the negotiated rulemaking process for a majority of its higher education rulemakings, which is a process that necessitates public participation from a broad range of stakeholders. Under negotiated rulemaking, the Department seeks and considers initial input through public hearings and written comments when it announces intent to establish a negotiated rulemaking committee and requests nominations from the public for individual negotiators who represent key stakeholder constituencies for the issues to be negotiated to serve on the committee before a committee is established.

To facilitate the public's involvement, we participate in the Federal Docket Management System (FDMS), an electronic single Government-wide access point ( www.regulations.gov) that enables the public to submit comments on different types of Federal regulatory documents as well as read and respond to comments submitted by other members of the public during the public comment period. This system provides the public with the opportunity to submit comments electronically on any notice of proposed rulemaking or interim final regulations open for comment as well as read and print any supporting regulatory documents.

III. Regulatory Priorities

This Administration's goals are to return power over education to families instead of bureaucracies, return education authority to the states, continue provision of services, programs and benefits on which Americans rely, and ensure that Federal funds support students and families instead of extreme ideologies that divide Americans by race and deny that sex is a binary, immutable human characteristic.

The Department expects to initiate several deregulatory actions and continue rescinding burdensome guidance documents across all ( printed page 52826) programs. The Department will focus on completing regulatory actions that streamline existing regulations and remove unjustified burdens as well as reduce government transfers and promote principles of fiscal responsibility. The Department also considered ideas the public submitted to OMB through the Notice of request for information: Deregulation. 90 FR 15481 (April 11, 2025). Many of the deregulatory actions described below align with the ideas the public submitted and are already being put into action.

Postsecondary Education

Section 492 of the Higher Education Act (HEA) requires that the Secretary solicit public involvement in the development of regulations before publishing proposed rules implementing programs authorized under Title IV. In the Reimagining and Improving Student Education (RISE) proposed rule, the Department intends to propose regulations after completing negotiated rulemaking and reaching consensus to implement the changes the One Big Beautiful Bill Act, Public Law. 119-21, made to the student loans programs. Proposed changes include phasing out graduate PLUS Loans; eliminating income contingent repayment (ICR) and Pay As You Earn (PAYE) loans, setting loan limits at $20,000 for graduate students and $50,000 for professional students and creating a new loan repayment plan known at the “Repayment Assistance Plan.” The Department also engaged in negotiated rulemaking to propose regulations implementing the One Big Beautiful Bill's changes to Pell Grants and accountability provisions, including updates to the Workforce Pell Grant program that offers Pell Grants to students for short-term training programs. In addition, the proposed rules will address institutional accountability issues including financial value transparency and gainful employment. These rules seek to enhance oversight, strengthen eligibility standards, and streamline implementation.

The Department intends to propose regulations covering institutions' reporting of statutorily defined gifts, contracts, and/or restricted and conditional gifts or contracts from or with defined foreign sources, pursuant to the requirements of section 117 of the HigherEA. In compliance with Executive Order 14279, Reforming Accreditation To Strengthen Higher Education, negotiated rulemaking will address accreditation issues to clarify institutional flexibility to pursue changes of accreditors without prior Department approval and remove other burdensome requirements that erect barriers to entry for new accreditation agencies. Also, the Department proposes to address Title IV eligibility issues to remove requirements that unnecessarily target faith-based or for-profit institutions and interfere with efficient and beneficial mergers, sales, and transfers of institutions of higher education. Such issues to be addressed in the context of institutional eligibility for participation of Federal student financial aid include rules governing change of ownership, cash management, administrative capability standards, and financial responsibility requirements.

In the Reducing Anti-Competitive Regulatory Barriers proposed rule, the Department seeks to implement President Trump's Executive Order 14267, Reducing Anti-Competitive Regulatory Barriers, and will engage in negotiated rulemaking to promulgate rules to (1) amend college textbook packaging rules under 34 CFR 668.163(c)(2) to put downward pressure on prices by promoting competition among booksellers and (2) improve the transferability of college credits.

Civil Rights

The Department intends to remove the regulation under Title VI of the 1964 Civil Rights Act that utilizes a disparate impact theory of race-based discrimination. We will align Department regulations with Supreme Court precedent that requires Title VI violations to rest upon intentional discrimination.

Executive Order 14168, Defending Women From Gender Ideology Extremism and Restoring Biological Truth to the Federal Government, defends women's rights and protects freedom of conscience by directing agencies to use clear and accurate language and policies that recognize women are biologically female, and men are biologically male. The Department intends to amend regulations implementing Title IX of the Education Amendments of 1972 (Title IX) to ensure consistency with E.O. 14168 by clarifying that implementation of Title IX is to be based on sex, which shall refer exclusively to an individual's immutable biological classification as either male or female.

In the Update of Regulations of Title VI of the Civil Rights Act of 1964 proposed rule, the Department intends to amend regulations implementing Title VI of the Civil Rights Act of 1964 (Title VI) to provide further clarification of how Title VI's provisions protecting individuals from discrimination on the basis of race, color and national origin protect individuals on the basis of the individual's actual or perceived shared ancestry or ethnic characteristics, or affiliation with a dominant religion or distinct religious identity. The Department will continue to implement President Trump's Executive Order 14188, Additional Measures to Combat Anti-Semitism, and use all available and appropriate legal tools, to tackle unlawful anti-Semitic harassment and violence.

Special Education and Rehabilitative Services

In the Equity in IDEA proposed rule, the Department intends to amend regulations implementing the Individuals with Disabilities Education Act's (IDEA) provisions pertaining to significant disproportionality. Specifically, the Department intends to amend 2016 regulations that established a standard methodology States must use to determine whether significant disproportionality based on race and ethnicity is occurring in the State and set specific programmatic requirements on how states are required to comply with Section 618(d)(2) of the IDEA.

Other Actions

The Department will work on a proposed rulemaking relating to Department grant programs to ensure that federal public benefits are only provided to citizens and eligible noncitizens, as required under the Personal Responsibility and Work Opportunity Reconciliation Act of 1996.

III. Principles for Regulating

Over the next year, the Department may need to issue other regulations because of new legislation or programmatic changes. In deciding when to regulate, we consider the following:

Whether regulations are essential to promote quality and equality of opportunity in education.
Whether a demonstrated problem cannot be resolved without regulation.
Whether regulations are necessary to provide a legally binding interpretation to resolve ambiguity.
Whether regulations are needed to protect the Federal interest, that is, to ensure that Federal funds are used for their intended purpose and to eliminate fraud, waste, and abuse.

In deciding how to regulate, we are mindful of the following principles:

Regulate no more than necessary.
Minimize burden to the extent possible and promote multiple approaches to meeting statutory requirements if possible. ( printed page 52827)
Encourage coordination of federally funded activities with State and local reform activities.
Ensure that the benefits justify the costs of regulating.
To the extent possible, establish performance objectives rather than specify the behavior or manner of compliance a regulated entity must adopt.
Encourage flexibility, to the extent possible and as needed to enable institutional forces to achieve desired results.

ED—Office for Civil Rights (OCR)	Final Rule Stage

27. ELIMINATION OF DISPARATE IMPACT THEORY UNDER TITLE VI OF THE 1964 CIVIL RIGHTS ACT

Priority: Other Significant

Regulatory Accounting: Deregulatory

Legal Authority: 42 U.S.C. 2000d-1; 20 U.S.C. 1682; 29 U.S.C. 794

Relevant Executive Orders: 14281

CFR Citation: 34 CFR 100

Legal Deadline: None

Abstract: The Department intends to remove the regulation under Title VI of the 1964 Civil Rights Act that utilizes a disparate impact theory of race-based discrimination, to align Department regulations with Supreme Court precedent that requires Title VI violations to rest upon intentional discrimination, to otherwise ensure compliance with constitutional and statutory requirements, and to remove outdated materials.

Statement of Need: The Department is rescinding portions of its regulations promulgated pursuant to Title VI, 42 U.S.C. 2000d-1, to more closely align its regulations to apply to the intentionally discriminatory conduct that Congress prohibited when enacting Title VI statute, 42 U.S.C. 2000d and to ensure its regulations comply with Executive Order 14821, Restoring Equality of Opportunity and Meritocracy, issued on April 23, 2025.

Summary of Legal Basis: The Department is rescinding portions of its regulations pursuant to Title VI, 42 U.S.C. 2000d-1. Executive Order 14281 requires federal agencies to eliminate the use of disparate-impact liability in all contexts to the maximum degree possible to avoid violating the Constitution, federal civil rights laws, and basic American ideals.

Alternatives: This will be discussed in the action taken by the agency that is published in the Federal Register .

Anticipated Cost and Benefits: This will be discussed in the action taken by the agency that is published in the Federal Register .

Risks: This will be discussed in the action taken by the agency that is published in the Federal Register .

Timetable:

Action	Date	FR Cite
Final Action	07/00/26

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Meir Katz, Department of Education, Office for Civil Rights, 400 Maryland Ave SW, Washington, DC 20202

Phone: 202 999-9999

Email: meir.katz@ed.gov

RIN: 1870-AA20

ED—OCR

28. • IMPLEMENTATION OF TITLE IX BASED ON DEFINITION OF “SEX” IDENTIFIED IN E.O. 14168

Priority: Other Significant. Major status under 5 U.S.C. 801 is undetermined.

Regulatory Accounting: Other

Unfunded Mandates: Undetermined

Legal Authority: Not Yet Determined

Relevant Executive Orders: 14168

CFR Citation: Not Yet Determined

Legal Deadline: None

Abstract: The Department intends to amend regulations implementing Title IX of the Education Amendments of 1972 (Title IX) to ensure consistency with Executive Order 14168, Defending Women From Gender Ideology Extremism and Restoring Biological Truth to the Federal Government (January 20, 2025), including clarifying that implementation of Title IX is to be based on sex, which shall refer exclusively to an individual's immutable biological classification as either male or female.

Statement of Need: The Department is amending portions of its regulations promulgated pursuant to Title IX of the Education Amendments Act, codified at 20 U.S.C. 1681, to more closely align its regulations with Executive Order 14168, Defending Women from Gender Ideology Extremism and Restoring Biological Truth to the Federal Government, issued on January 20, 2025.

Summary of Legal Basis: The Department is amending portions of its regulations pursuant to Title IX of the Education Amendments Act, 20 U.S.C. 1681. Executive Order 14168 directs federal agencies to recognize the existence of only two sexes, male and female, that are not changeable and are grounded in fundamental and incontrovertible reality.

Alternatives: This will be discussed in the action taken by the agency that is published in the Federal Register .

Anticipated Cost and Benefits: This will be discussed in the action taken by the agency that is published in the Federal Register .

Risks: This will be discussed in the action taken by the agency that is published in the Federal Register .

Timetable:

Action	Date	FR Cite
Final Action	07/00/26

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Federalism: Undetermined

Agency Contact: David Samberg, Department of Education, Office for Civil Rights, 400 Maryland Avenue SW, 5th, Washington, DC 20202

Phone: 202 999-9999

Email: david.samberg@ed.gov.

RIN: 1870-AA23

ED—Office of Postsecondary Education (OPE)	Prerule Stage

29. DOCUMENTATION OF FOREIGN SOURCE GIFTS AND CONTRACTS, SECTION 117 OF THE HIGHER EDUCATION ACT OF 1965

Priority: Other Significant

Regulatory Accounting: Regulatory

Legal Authority: 20 U.S.C. 1011f

CFR Citation: 34 CFR 668; 34 CFR 695

Legal Deadline: None

Abstract: The Department intends to propose regulations covering institutions' reporting of statutorily defined gifts, contracts, and/or restricted and conditional gifts or contracts from or with defined foreign sources, pursuant to the requirements of section 117 of the Higher Education Act of 1965, as amended (HEA).

Statement of Need: Section 117 of the Higher Education Act of 1965, as amended, codified at 20 U.S.C. 1011f, requires that institutions of higher education that receive federal funding must biannually disclose to the Department of Education foreign gifts, contracts, and ownership, the value of which (alone or combined) is $250,000 or more annually. In an official report published by the Department in October 2020 (Institutional Compliance with Section 117 of the Higher Education Act of 1965), the Department reported findings of widespread noncompliance with Section 117's relatively simple disclosure requirements amounting to ( printed page 52828) billions of dollars in unreported but qualifying foreign funding transactions. The Department's review of IHE disclosures indicates significant improvements in compliance, although noncompliance continues to occur at unacceptably high levels. Evidence obtained by the Department through disclosures submitted by IHEs and records obtained by the Department through its civil investigations have revealed significant continued noncompliance by IHEs.

Issued on Apr. 22, 2025, Executive Order 14282 (Transparency Regarding Foreign Influence at American Universities) further clarified the need for significantly improved enforcement of Section 117's disclosure requirements. The Department is statutorily obligated to provide robust enforcement of Section 117's disclosure requirements as required by Congress to ensure transparency with regard to foreign funding and involvements in higher education.

Summary of Legal Basis: Section 117 of the Higher Education Act of 1965, as amended, codified at 20 U.S.C. 1011f, requires that institutions of higher education that receive federal funding must biannually disclose to the Department of Education foreign gifts, contracts, and ownership, the value of which (alone or combined) is $250,000 or more annually. The current version of this disclosure requirement was adopted in 1998, see Public Law 105-244, Higher Education Amendments of 1998, Title I, sec. 102(a), adding HEA Title I, sec. 117 (Oct. 7, 1998); but a substantially similar disclosure requirement has been in place since 1986. See Public Law 99-498, Higher Education Amendments of 1986, Title XII, sec. 1206, adding HEA Title XII, sec. 1207 (Oct. 17, 1986) (then codified at 20 U.S.C. 1145d). In addition, IHEs are required to accurately and timely report qualifying Section 117 foreign funding under their Program Participation Agreements (PPAs) with the Department, pursuant to 20 U.S.C. 1094(a)(17), which provides that [i]n order to be an eligible institution for the purposes of any program authorized under this subchapter, an institution must . . . enter into a program participation agreement with the Secretary. The agreement shall condition the initial and continuing eligibility of an institution to participate in a program upon compliance with the following requirements: . . . (17) The institution will complete surveys conducted as a part of the Integrated Postsecondary Education Data System (IPEDS) or any other Federal postsecondary institution data collection effort, as designated by the Secretary, in a timely manner and to the satisfaction of the Secretary. Under 20 U.S.C. 1094(a)(17), where an IHE fails to report Section 117 information timely and accurately, the IHE has failed to comply with its reporting obligations under 20 U.S.C. 1011f and failed to comply with the requirements contained in its PPA.

Alternatives: The Department's ongoing information collection efforts, vastly improved through the Department's creation of a new foreign funding reporting portal ( www.ForeignFundingHigherEd.gov), is the least costly alternative for securing improved compliance by IHEs with Section 117's straightforward requirements. The new reporting portal also facilitates compliance by IHEs through a significantly more user-friendly reporting portal.

Anticipated Cost and Benefits: The Department executed a Firm Fixed Price (FFP) Contract in support of the creation and maintenance of the new foreign funding reporting portal ( www.ForeignFundingHigherEd.gov). The original contract obligated $9,828,256.13 for an initial nine-month base year through June 18, 2026, and included four twelve-month option years thereafter that would bring the potential award to over $60 million.

Risks: There are significant national security risks associated with the failure to timely and accurately disclose foreign funding to IHEs, particularly to federally funded research universities (which receive approximately $65 billion annually in support of sometimes highly classified weapons-related technological developments ( i.e., critical emerging technologies). Universities often have significant contracts for the operation of important national laboratories ( e.g., the Los Alamos National Laboratory a Department of Energy national laboratory with well known historical and current involvements is managed by Texas A&M University; NASA's Jet Propulsion Laboratory critically important to U.S. space involvements and related technologies is managed by the California Institute of Technology). In addition, foreign influence operations on IHE campuses continue to be deeply concerning to Congress, the President, and the American people. Section 117's transparency requirements continue to play an important statutory role in providing Congress, the President, and the American people with important ongoing knowledge regarding efforts to safeguard America's research enterprise.

Timetable:

Action	Date	FR Cite
Notice of Intent to Commence Negotiated Rulemaking	11/00/26

Regulatory Flexibility Analysis Required: No

Government Levels Affected: Undetermined

URL For Public Comments: www.regulations.gov

Agency Contact: Paul Moore, Chief Investigative Counsel, Office of the General Counsel, Department of Education, Office of Postsecondary Education, 400 Maryland Avenue SW, Seventh Floor, Washington, DC 20202

Phone: 999 999-9999

Email: paul.moore@ed.gov

RIN: 1840-AD50

ED—OPE

30. • REDUCING ANTI-COMPETITIVE REGULATORY BARRIERS

Priority: Other Significant. Major status under 5 U.S.C. 801 is undetermined.

Regulatory Accounting: Other

Unfunded Mandates: Undetermined

Legal Authority: Not Yet Determined

Relevant Executive Orders: 14267

CFR Citation: Not Yet Determined

Legal Deadline: None

Abstract: To implement President Trump's Executive Order 14267 on anti-competitive regulations, the Department will engage in negotiated rulemaking to promulgate rules to (1) amend college textbook packaging rules under 34 CFR 668.163(c)(2) to put downward pressure on prices by promoting competition among booksellers; and (2) improve the transferability of college credits.

Statement of Need: This rule amends and aligns Department regulations with Executive Order 14267, Reducing Anti-Competitive Regulatory Barriers, issued on April 9, 2025 to amend college textbook packaging rules under 34 CFR 668.163(c)(2) to put downward pressure on prices by promoting competition among booksellers and to improve the transferability of college credits.

Summary of Legal Basis: The Department is amending portions of its regulations pursuant to title IV of the Higher Education Act of 1965, as amended, codified at 20 U.S.C. 1070. Executive Order 14267 mandates federal agencies to identify and rescind regulations that create monopolies, create unnecessary barriers to entry for new market participants, limit competition, or otherwise impose anti-competitive restraints or distortions on the operation of the free market. ( printed page 52829)

Alternatives: Alternatives will be discussed in the notice of proposed rulemaking and final rule.

Anticipated Cost and Benefits: Anticipated Costs and Benefits will be discussed in the notice of proposed rulemaking and final rule.

Risks: Risks will be discussed in the notice of proposed rulemaking and final rule.

Timetable:

Action	Date	FR Cite
Notice of Intent to Commence Negotiated Rulemaking	09/00/26

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Federalism: Undetermined

Agency Contact: Jeffrey R. Andrade, Deputy Assistant Secretary for Policy, Planning and Innovation, Department of Education, Office of Postsecondary Education, 400 Maryland Avenue SW, Washington, DC 20202

Phone: 202 708-7888

RIN: 1840-AE01

ED—OPE

31. • ADDRESSING TITLE IV ELIGIBILITY ISSUES

Priority: Other Significant. Major status under 5 U.S.C. 801 is undetermined.

Regulatory Accounting: Deregulatory

Unfunded Mandates: Undetermined

Legal Authority: Not Yet Determined

Relevant Executive Orders: 14267

CFR Citation: Not Yet Determined

Legal Deadline: None

Abstract: The Department proposes to address Title IV eligibility issues to remove requirements that unnecessarily target faith-based or for-profit institutions and interfere with efficient and beneficial mergers, sales, and transfers of institutions of higher education. Such issues to be addressed in the context of institutional eligibility for participation of Federal student financial aid include rules governing change of ownership, cash management, administrative capability standards, program length requirements, and financial responsibility requirements. This rule would also remove ultra vires provisions in the Title IV Revenue and Non-Federal Education Assistance Funds regulations called the 90/10 Rule that give public and nonprofit institutions a competitive advantage and update Ronald E. McNair Postbaccalaureate Achievement Program regulations consistent with the December 2, 2025 opinion published by the Office of Legal Counsel at the Department of Justice entitled, “Constitutionality of Race-Based Department of Education Programs,” regarding that program.

Statement of Need: The rule will address Title IV eligibility issues to remove requirements that unnecessarily target faith-based or for-profit institutions and interfere with efficient and beneficial mergers, sales, and transfers of institutions of higher education.

Summary of Legal Basis: The Department is amending portions of its regulations pursuant to title IV of the Higher Education Act of 1965, as amended, codified at 20 U.S.C. 1070.

Alternatives: Alternatives will be discussed in the notice of proposed rulemaking and final rule.

Anticipated Cost and Benefits: Anticipated Costs and Benefits will be discussed in the notice of proposed rulemaking and final rule.

Risks: Risks will be discussed in the notice of proposed rulemaking and final rule.

Timetable:

Action	Date	FR Cite
Notice of Intent to Commence Negotiated Rulemaking	07/00/26

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Federalism: Undetermined

Agency Contact: Tamy Abernathy, Department of Education, Office of Postsecondary Education, 400 Maryland Avenue SW, Washington, DC 20202

Phone: 202 245-4595

Email: negregnprmhelp@ed.gov

RIN: 1840-AE04

ED—OPE	Proposed Rule Stage

32. ACCREDITATION ISSUES

Priority: Other Significant

Regulatory Accounting: Deregulatory

Legal Authority: 20 U.S.C. 1099b

Relevant Executive Orders: 14279

CFR Citation: 34 CFR 600; 34 CFR 602

Legal Deadline: None

Abstract: The Department proposes to engage in negotiated rulemaking to address accreditation issues to clarify institutional flexibility to pursue changes of accreditors without prior Department approval and remove other burdensome requirements that erect barriers to entry for new accreditation agencies.

On December 26, 2024, the Department issued a Notice of Termination of negotiated rulemaking process for State Authorization, Cash Management, Accreditation and Related Issues closing the Notice of Intent to Commence Negotiated Rulemaking, 88 FR 43069 (July 6, 2023).

Statement of Need: This rule aligns Department regulations with Executive Order 14279, Reforming Accreditation to Strengthen Higher Education, issued on April 23, 2025, particularly to clarify institutional flexibility to pursue changes of accreditors without prior Department approval and remove other burdensome requirements that erect barriers to entry for new accreditation agencies.

Summary of Legal Basis: The Department is conducting this rulemaking under 20 U.S.C. 1099b.

Executive Order 14279 requires the Department to reform the Higher Education Accreditation system in the following ways: (1) ensure programs are free from unlawful discrimination, (2) allow institutions to adopt practices that advance credential and degree completion, (3) require institutions to prioritize academic freedom, (4) inhibit accreditors from using their role to violate State laws, and (5) prohibit accreditors from engaging in practices that result in burdensome costs to students.

Alternatives: Alternatives will be discussed in the notice of proposed rulemaking and final rule.

Anticipated Cost and Benefits: Anticipated Costs and Benefits will be discussed in the notice of proposed rulemaking and final rule.

Risks: Risks will be discussed in the notice of proposed rulemaking and final rule.

Timetable:

Action	Date	FR Cite
Notice of Intent to Commence Negotiated Rulemaking	01/27/26	91 FR 3403
NPRM	07/00/26

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

URL For Public Comments: www.regulations.gov

Phone: 202 708-7888

RIN: 1840-AD82

ED—Office of Special Education and Rehabilitative Services (OSERS)	Proposed Rule Stage

33. • EQUITY IN IDEA (INDIVIDUALS WITH DISABILITIES EDUCATION ACT)

Priority: Other Significant. Major status under 5 U.S.C. 801 is undetermined.

Regulatory Accounting: Deregulatory

Unfunded Mandates: Undetermined

Legal Authority: Not Yet Determined

CFR Citation: Not Yet Determined

Legal Deadline: None

Abstract: The Department intends to amend regulations implementing the Individuals with Disabilities Education Act's (IDEA) provisions pertaining to significant disproportionality. Specifically, the Department intends to amend 2016 regulations that established a standard methodology States must use to determine whether significant disproportionality based on race and ethnicity is occurring in the State and set specific programmatic requirements on how states are required to comply with Section 618(d)(2) of the IDEA.

Statement of Need: The Individuals with Disabilities Education Act (IDEA), codified at 20 U.S.C. 1400-82, requires that the Secretary must ensure that all regulations implementing IDEA are compliance with federal civil rights laws and uphold both procedural and substantive protections under IDEA including ensuring that all children with disabilities are identified, evaluated and receive special education and related services for which they are eligible.

Summary of Legal Basis: The U.S. Department of Education (ED) has statutory authority under IDEA, codified at 20 U.S.C. 1400-82 to propose, issue, amend, or repeal regulations that implement the law.

Alternatives: Alternatives will be discussed in the notice of proposed rulemaking and final rule.

Anticipated Cost and Benefits: Anticipated Costs and Benefits will be discussed in the notice of proposed rulemaking and final rule.

Risks: Risks will be discussed in the notice of proposed rulemaking and final rule.

Timetable:

Action	Date	FR Cite
NPRM	08/00/26

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Federalism: Undetermined

Agency Contact: Erin McHugh, Department of Education, Office of Special Education and Rehabilitative Services, 400 Maryland Ave SW, Washington, DC 20202

Phone: 202 245-6248

RIN: 1820-AB84

BILLING CODE 4000-01-P

Department of Energy

Statement of Regulatory and Deregulatory Priorities

The Department of Energy (Department or DOE) makes vital contributions to the Nation's welfare through its activities focused on improving national security, energy supply, energy efficiency, environmental remediation, and energy research. The Department's mission is to:

Promote dependable and affordable energy production and distribution;
Advance energy efficiency and conservation;
Provide responsible stewardship of the Nation's nuclear weapons;
Provide a responsible resolution to the environmental legacy of nuclear weapons production; and
Strengthen U.S. scientific discovery, economic competitiveness, and improve quality of life through innovations in science and technology.

The Department's regulatory activities are essential to achieving its critical mission and to implementing President Trump's energy dominance initiatives. Among other things, the Regulatory Plan and the Unified Agenda contain the rulemakings the Department will be engaged in during the coming year. The Regulatory Plan and Unified Agenda also reflect the Department's continuing commitment to cut costs, eliminate red tape, reduce regulatory burden, increase consumer choice, and promote market competition and innovation as directed through Departmental priorities and recent executive orders. Additionally, DOE recognizes that public participation and community engagement are a crucial aspect of the Department's rulemaking process, as well as an important vehicle to assist the Department in streamlining its deregulatory priorities to meet Administration goals as well.

As a general matter, the Department is undertaking a broad review of its regulatory and deregulatory actions. In the Spring of 2025 and in response to Executive Orders (E.O.) 14192 and 14219, the Department initiated an internal review of its existing regulations and guidance materials with the aim of identifying any redundant or unused regulatory mechanisms. The Department has used the results of that internal review to identify several opportunities for deregulatory activity. Overall, the Department has completed 15 deregulatory activities, as identified under E.O. 14192. More specifically, the Department would like to highlight the following ongoing actions.

One rulemaking being undertaken by the Department in FY 2026 addresses proposed revisions to the value for the petroleum-equivalency factor (PEF). This rulemaking would revise DOE's regulations regarding procedures for calculating a value for the petroleum-equivalent fuel economy of electric vehicles (EVs). The PEF is used by the Environmental Protection Agency (EPA) in calculating light-duty vehicle manufacturers' compliance with the Department of Transportation's (DOT) Corporate Average Fuel Economy (CAFE) standards. This rulemaking action is in response to an Eighth Circuit Court of Appeals decision that vacated Petroleum-Equivalent Fuel Economy Calculation,89 FR 22041 (Mar. 29, 2024) (2024 PEF Final Rule).

DOE is also considering potential revisions to the Department's current rulemaking guidance titled “Procedures, Interpretations, and Policies for Consideration of New or Revised Energy Conservation Standards and Test Procedures for Consumer Products and Certain Commercial/Industrial Equipment” (Process Rule), which was last modified in 2024. The goal of the Process Rule is to increase transparency by elaborating on the procedures, interpretations, and policies that would guide the Department in establishing new or revised energy conservation standards and test procedures for covered consumer products and commercial/industrial equipment. DOE is considering a notice-and-comment rulemaking to amend its Process Improvement Rule to reflect statutory changes, as well as innovative, collaborative approaches to reflect more efficient rulemaking. This rulemaking advances the objectives of E.O. 14154 and E.O. 14219 by ensuring that the rulemaking process for the Appliance Standards Program meets the energy and cost savings objectives of EPCA while preserving consumer choice and minimizing regulatory burdens.

In addition, as part of a nuclear regulatory reform effort directed by E.O. 14301, DOE is proposing to streamline and modernize its regulations for worker safety and health to expedite the deployment of advanced reactors under DOE's jurisdiction. These amendments ( printed page 52831) will incorporate lessons learned from decades of operating experience at DOE nuclear facilities while continuing to ensure worker safety and health. Benefits of these amendments include: increased flexibility for DOE's Office of Nuclear Energy contractors to implement current industry and government standards, streamlined compliance processes, and a greater focus on risk management.

Lastly, the One Big Beautiful Bill Act (OBBBA) amended the Energy Infrastructure Reinvestment Program authorized by Title XVII of the Energy Policy Act of 2005, as amended. The OBBBA amendments, specifically its Energy Dominance Financing provisions, necessitate immediate and material changes to the regulations set forth at 10 CFR part 609. Through an interim final rule, DOE is amending 10 CFR part 609 to incorporate the Energy Dominance Financing provisions, which include new and amended categories of eligible projects. The interim final rule allows DOE to continue processing Title XVII applications for a broad range of energy infrastructure projects up to a total principal amount of $250 billion (through September 30, 2028). The rulemaking will also reduce a Title XVII applicants' reporting burden, which translates to a cost savings.

DOE—Energy Efficiency and Renewable Energy (EE)	Proposed Rule Stage

34. PROCEDURES, INTERPRETATIONS, AND POLICIES FOR CONSIDERATION IN NEW OR REVISED ENERGY CONSERVATION STANDARDS AND TEST PROCEDURES FOR CONSUMER PRODUCTS AND COMMERCIAL/INDUSTRIAL EQUIPMENT

Priority: Other Significant

Regulatory Accounting: Deregulatory

Legal Authority: 42 U.S.C. 6291-6317; 5 U.S.C. 553(d)

Relevant Executive Orders: 14154; 13272; 13132; 13211

CFR Citation: 10 CFR part 430, subpart C, appendix A

Legal Deadline: None

Abstract: The U.S. Department of Energy (DOE or the Department) is considering potential revisions to the Department's current rulemaking guidance titled “Procedures, Interpretations, and Policies for Consideration of New or Revised Energy Conservation Standards and Test Procedures for Consumer Products and Certain Commercial/Industrial Equipment” (Process Rule), which was last modified in 2024. DOE is considering a notice-and-comment rulemaking to amend its Process Improvement Rule to reflect statutory changes as well as innovative, collaborative approaches to reflect more efficient rulemaking. Any rulemaking action will be consistent with the President's direction in Executive Order 14154, Unleashing American Energy, to preserve consumer choice as well as DOE's statutory obligation to preserve appliance features in the market.

Statement of Need: On January 20, 2025, the President issued Executive Order 14154, Unleashing American Energy (E.O. 14154). 90 FR 8353 (Jan. 29, 2025). That order stated the policy of the United States with regard to energy production and management. Among the stated elements of this policy, section 1(f)-(h) of E.O. 14154 cite the intent to safeguard the American people's freedom to choose from a variety of goods and appliances, including but not limited to lightbulbs, dishwashers, washing machines, gas stoves, water heaters, toilets, and shower heads, and to promote market competition and innovation within the manufacturing and appliance industries; to ensure that the global effects of a rule, regulation, or action shall, whenever evaluated, be reported separately from its domestic costs and benefits, in order to promote sound regulatory decision making and prioritize the interests of the American people; and to guarantee that all Executive departments and agencies provide opportunity for public comment and rigorous, peer-reviewed scientific analysis. Section 6 of the Executive order also specifies policies for prioritizing accuracy in environmental analyses, specifically instructing that for Federal regulatory processes, all agencies shall adhere to only the relevant legislated requirements for environmental considerations and any considerations beyond those requirements are eliminated. Section 6 of the Executive order also provides instructions regarding consideration of greenhouse gas emissions and the social cost of carbon.

On February 19, 2025, the President issued Executive Order 14219, Ensuring Lawful Governance and Implementing the President's `Department of Government Efficiency' Deregulatory Initiative (E.O. 14219). 90 FR 10583 (Feb. 25, 2025). That order stated the policy of the United States to end Federal regulatory overreach and restore the constitutional separation of powers. Among the stated elements of this policy, E.O. 14219 calls for review of certain categories of regulations. Among these, section 2(a)(v) cites regulations that impose significant costs upon private parties that are not outweighed by public benefits, and section 2(a)(vii) cites regulations that impose undue burdens on small business and impede private enterprise and entrepreneurship.

To implement E.O. 14154 and E.O. 14219, the Department, among other actions, is evaluating existing policy regarding its approach to consideration of new or amended energy conservation standards and test procedures for consumer products and certain commercial and industrial equipment. In furtherance of this reassessment, DOE is considering revisions to the Process Rule, which DOE generally uses to prescribe energy conservation standards and test procedures for both consumer products and commercial equipment pursuant to the Energy Policy and Conservation Act of 1975, as amended (42 U.S.C. 6291, et seq.).

Summary of Legal Basis: The Energy Policy and Conservation Act, Public Law 94-163, as amended (EPCA), authorizes DOE to regulate the energy efficiency of a number of consumer products and certain industrial equipment. (42 U.S.C. 6291-6317, as codified) Title III, Part B of EPCA established the Energy Conservation Program for Consumer Products Other Than Automobiles. (42 U.S.C. 6291-6309, as codified) Title III, Part C of EPCA, added by Public Law 95-619, Title IV, section 441(a), established the Energy Conservation Program for Certain Industrial Equipment, which sets forth a variety of provisions designed to improve energy efficiency. (42 U.S.C. 6311-6317, as codified) Under EPCA, DOE's energy conservation program consists essentially of four parts: (1) testing, (2) labeling, (3) the establishment of Federal energy conservation standards, and (4) certification and enforcement procedures.

In July of 1996, pursuant to EPCA, DOE published a final rule in the Federal Register that codified DOE's Procedures, Interpretations and Policies for Consideration of New or Revised Energy Conservation Standards for Consumer Products at 10 CFR part 430, subpart C, appendix A. 61 FR 36974 (July 15, 1996). The goal of the Process Rule was to increase transparency by elaborating on the procedures, interpretations, and policies that would guide the Department in establishing new or revised energy conservation standards for consumer products. DOE subsequently updated the Process Rule in 2020, 2021, and 2024 to reflect analytical best practices and technological and legal developments. See85 FR 8626 (Feb. 14, 2020); 85 FR ( printed page 52832) 50937 (August 19, 2020); 86 FR 70892 (Dec. 13, 2021), and 89 FR 24340 (April 8, 2024).

This rulemaking advances the objectives of E.O. 14154 and E.O. 14219 by ensuring that the rulemaking process for the Appliance Standards Program meets the energy and cost savings objectives of EPCA while preserving consumer choice and minimizing regulatory burdens.

Alternatives: DOE will issue a notice of proposed rulemaking (NOPR) considering amendments to the Process Rule, after a careful review of public comments on the April 17, 2025 RFI. In determining whether and how to update the existing Process Rule, DOE may consider alternatives such as taking no further action or examining approaches different from those proposed in the NOPR, based upon public comments and additional information received in response to the NOPR.

Anticipated Cost and Benefits: This proposed rulemaking has also been determined to be an E.O. 14192 deregulatory action because it intends to reduce the burden to society by streamlining the regulatory framework and improving efficiency for regulated entities and the interested public. These benefits are difficult to quantify, but they may involve reduced manufacturer administrative burdens, lower appliance first costs, and expanded consumer choice.

Risks: N/A

Timetable:

Action	Date	FR Cite
Request for Information (RFI)	04/17/25	90 FR 16093
Comment Period End	06/02/25
NPRM	07/00/26

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: None

Agency Contact: Troy Watson, Project Manager, Department of Energy, Energy Efficiency and Renewable Energy, U.S. Department of Energy, 1000 Independence Avenue SW, Mail Stop EE-5B, Washington, DC 20585

Phone: 240 449-9387

Email: troy.watson@ee.doe.gov

Related RIN: Related to 1904-AD38, Related to 1904-AF13

RIN: 1904-AF72

DOE—EE	Final Rule Stage

35. PETROLEUM-EQUIVALENT FUEL ECONOMY CALCULATION

Priority: Other Significant

Regulatory Accounting: Deregulatory

Legal Authority: 49 U.S.C. 32904(a)(2)

Relevant Executive Orders: 14219; 14154; 13563

CFR Citation: 10 CFR part 474

Legal Deadline: None

Abstract: The U.S. Department of Energy (DOE) has reviewed the petroleum-equivalency factor (PEF) for electric vehicles (EVs) used by the Environmental Protection Agency (EPA) in calculating light-duty vehicle manufacturers' compliance with the Department of Transportation's (DOT) Corporate Average Fuel Economy (CAFE) standards. DOE has determined that revisions to the PEF are necessary. The interim final rule was published under RIN 1904-AF47.

Statement of Need: In Iowa v. Wright, several states and the American Free Enterprise Chamber of Commerce (AmFree) petitioned the Eighth Circuit Court of Appeals to review the 2024 PEF Final Rule that revised DOE's methodology to calculate the PEF used in determining the equivalent petroleum-based fuel economy values of EVs. On September 5, 2025, the Eighth Circuit issued a decision that vacated and remanded the 2024 PEF Final Rule to Doe for further consideration.

In addition, on January 20, 2025, the President issued Executive Order 14154, Unleashing American Energy (E.O. 14154). 90 FR 8353 (Jan. 29, 2025). E.O. 14154 stated the policy of the United States with regard to energy production and management. Among the stated elements of this policy, section 1(e) of E.O. 14154 cite the intent to eliminate the EV mandate and promote true consumer choice by removing regulatory barriers to motor vehicle access, ensuring a level regulatory playing field for consumer choice in vehicles, and eliminating unfair subsidies and other ill-conceived government-imposed market distortions that favor EVs over other technologies.

In response to the Eighth Circuit Court of Appeals decision in Iowa v. Wright, and to implement E.O. 14154, the Department, among other actions, is first publishing a notice of technical amendment to remove the revisions adopted in the 2024 PEF Final Rule from 10 CFR part 474. In addition, DOE is proposing revisions to procedures for calculating a value for the petroleum-equivalent fuel economy of electric vehicles (EVs).

Summary of Legal Basis: Title III of the Energy Policy and Conservation Act, Public Law 94-163, (EPCA), amended the Motor Vehicle Information and Cost Savings Act (the Motor Vehicle Act) by mandating fuel economy standards for automobiles produced in, or imported into, the United States. This legislation, as amended, requires every manufacturer to meet applicable specified corporate average fuel economy standards for their fleets of light-duty vehicles under 8,500 pounds that the manufacturer manufactures in any model year. The Secretary of Transportation is responsible for prescribing the CAFE standards and enforcing the penalties for failure to meet these standards. 49 U.S.C. 32902. The Administrator of the EPA is responsible for calculating each manufacturer's fleet CAFE value. 49 U.S.C. 32902 and 32904.

If an automobile manufacturer manufactures an EV, the Administrator of EPA shall include in the manufacturer's calculation of average fuel economy the equivalent petroleum based fuel economy values determined by the Secretary of Energy for various classes of EVs. 49 U.S.C. 32904(a)(2). The petroleum-equivalency factor is used to convert the energy efficiency of EVs to an equivalent petroleum-based fuel economy and is measured in Watt hours per gallon of gasoline.

This rulemaking advances the objectives of E.O. 14154 by ensuring that the Department`s regulations relating to the calculation of equivalent petroleum-based fuel economy do not create an unlevel playing field in favor of EVs while preserving consumer choice and minimizing regulatory burdens.

Alternatives: DOE will issue a notice of proposed rulemaking (NOPR) considering revisions to the petroleum equivalency factor consistent with the Eighth Circuit Court of Appeals decision in Iowa v. Wright and the Administration's policies. In determining how to revise the current PEF value, DOE may consider alternatives such as taking no further action.

Anticipated Cost and Benefits: DOE anticipates that the total costs are zero or will reduce regulatory burden to society.

Risks: N/A

Timetable:

Action	Date	FR Cite
Final Rule; technical amendment	01/08/26	91 FR 553
Final Rule; technical amendment Effective	01/08/26
Interim Final Rule; request for comments	02/19/26	91 FR 7810
Final Rule Effective	02/19/26
( printed page 52833)
Comment Period End	03/23/26

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Agency Contact: Kevin Stork, Department of Energy, 1000 Independence Avenue SW, Washington, DC 20585-0121

Phone: 202 586-8306

Email: kevin.stork@ee.doe.gov

Related RIN: Previously reported as 1904-AF47

RIN: 1904-AG09

DOE—Departmental and Others (ENDEP)	Proposed Rule Stage

36. • WORKER SAFETY AND HEALTH REQUIREMENTS TO SUPPORT REFORM OF NUCLEAR REACTOR TESTING

Priority: Other Significant

Regulatory Accounting: Deregulatory

Legal Authority: 42 U.S.C. 2201(i)(3); 42 U.S.C. 2201(p); 42 U.S.C. 2282c; 42 U.S.C. 5801 et seq.;42 U.S.C. 7101 et seq.;50 U.S.C. 2401 et seq.;. . .

Relevant Executive Orders: 14301; 14299; 14302

CFR Citation: 10 CFR 851

Legal Deadline: None

Abstract: The Department of Energy (DOE) proposes to amend its regulations for worker safety and health to expedite the review, approval, and deployment of advanced reactors under DOE's jurisdiction including qualified test reactors in DOE's reactor pilot program, consistent with Executive Order 14301. The revisions would ensure that DOE's worker safety and health program continues to protect workers, while incorporating lessons learned from decades of operating experience and fostering nuclear innovation and technologies to the benefit of the United States. Additionally, the proposed rule would make minor updates to these regulations to improve clarity.

Statement of Need: This rulemaking is necessary to expedite the deployment of advanced reactors under DOE's jurisdiction, as directed by E.O. 14301, which will contribute towards the Nation's supply of reliable, diversified, and affordable energy. This rulemaking is also necessary to streamline and modernize regulations for worker safety and health consistent with section 234C of the Atomic Energy Act of 1954 (AEA).

Summary of Legal Basis: Section 234C of the AEA (codified as 42 U.S.C. 2282c) requires DOE to promulgate worker safety and health regulations. These regulations are to include flexibility to tailor implementation to reflect activities and hazards associated with a particular work environment; to take into account special circumstances for facilities permanently closed or demolished, or for which title is expected to be transferred; and to achieve national security missions in an efficient and timely manner (42 U.S.C. 2282c(a)(3)).

Alternatives: One alternative approach that DOE considered but rejected was to make the proposed changes more broadly applicable to the Department as a whole rather than only to Office of Nuclear Energy contractors. However, given that the catalyst for the proposed changes, E.O. 14301, set forth an expedited timeline and affected only Office of Nuclear Energy contractors, the Department decided to focus these proposed changes on Office of Nuclear Energy contractors and defer changes affecting other DOE contractors for future consideration.

Anticipated Cost and Benefits: The estimated cost savings, while difficult to quantify precisely, are expected to be realized through time savings and increased efficiency. Specifically, the potential cost savings are estimated to be 1-3% of the contract value per year. For the Idaho National Laboratory, this would be on the order of $20-60 million per year. Faster decision-making and reduced administrative tasks can lead to significant savings in both time and resources.

Risks: Optional/no response.

Timetable:

Action	Date	FR Cite
NPRM	01/21/26	91 FR 2498
NPRM Comment Period	02/20/26
NPRM; Reopening of Public Comment Period	02/26/26	91 FR 9498
Reopened comment Period End	03/23/26
Final Action	07/00/26

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Daryn Moorman, Department of Energy, 1000 Independence Ave SW, Washington, DC 20585

Phone: 208 526-1270

Email: moormadj@id.doe.gov

RIN: 1901-AB74

DOE—ENDEP	Final Rule Stage

37. • ENERGY DOMINANCE FINANCING AMENDMENTS

Priority: Economically Significant. Major under 5 U.S.C. 801.

Regulatory Accounting: Deregulatory

Legal Authority: 42 U.S.C. 16511 et seq.;42 U.S.C. 7254; Pub.L. 119-21

Relevant Executive Orders: 14154; 14262; 14302; 14255

CFR Citation: 10 CFR 609

Legal Deadline: None

Abstract: The One Big Beautiful Bill Act amended the Energy Infrastructure Reinvestment Program administered by the U.S. Department of Energy's Loan Programs Office as authorized by Title XVII of the Energy Policy Act of 2005, as amended. The One Big Beautiful Bill Act, and its Energy Dominance Financing provisions, necessitate immediate and material changes to DOE's existing regulations set forth in 10 CFR part 609 to enable the continued processing of loan applications and issuance of loan guarantees for all categories of Title XVII projects. The loan authority and appropriations authorized under the One Big Beautiful Bill Act are available through September 30, 2028, making the implementation of the authority, and associated amendments, time-sensitive.

Statement of Need: The Energy Dominance Financing Amendments interim final rule would amend DOE's regulations implementing the Title XVII loan guarantee program to incorporate new categories of eligible projects and other provisions of the One Big Beautiful Bill Act. The rule would enable DOE to guarantee loans of up to a total principal amount of $250 billion through September 30, 2028, for a broad range of energy infrastructure projects.

Summary of Legal Basis: Title XVII of the Energy Policy Act of 2005, as amended (Title XVII) directs the Department of Energy to make loan guarantees for certain types of energy projects, after final regulations are issued. 42 U.S.C. 16515(b) & (d).

Alternatives: N/A

Anticipated Cost and Benefits: Reduce the reporting burden, which translates to a cost savings.

Risks: NA

Timetable:

Action	Date	FR Cite
Interim Final Rule	10/28/25	90 FR 48705
Interim Final Rule Effective	10/28/25
Interim Final Rule Comment Period End	12/29/25
Final Action	07/00/26

Regulatory Flexibility Analysis Required: No ( printed page 52834)

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Uchechukwu Nnaemeka Eze, Attorney-Advisor, Department of Energy, U.S. Department of Energy, 1000 Independence Avenue SW, Washington, DC 20585

Phone: 202 586-1092

Email: lpo.ifr@hq.doe.gov

RIN: 1901-AB72

BILLING CODE 6450-01-P

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Statement of Regulatory Priorities for Fiscal Year 2026

America faces an unprecedented healthcare crisis. With skyrocketing costs—nearing $4.5 trillion annually—essential care has become unaffordable for millions of Americans.

To meet this generational challenge, the U.S. Department of Health and Human Services (HHS) will unlock innovation and apply “Make America Healthy Again” (MAHA) principles to improve the health and well-being of Americans, including with its regulatory agenda. The 2026 HHS regulatory plan prioritizes actions to promote health, manage chronic diseases; eliminate unnecessary administrative expenses and rent-seeking practices; combating fraud and abuse; protecting religious and individual liberties; supporting biological women, children, and families; and radical transparency. HHS is committed to fixing a system that rewards ineffective health care practices and delivers poor value.

This agenda highlights certain rulemakings that promote open government, reduce government transfers, and support small businesses, to ensure a transparent and efficient regulatory framework that promotes and protects public health.

I. Promoting Health and Managing Chronic Disease

Addressing chronic disease, the most pressing public health problem of our time—is the cornerstone of the MAHA agenda. In less than a year, under Secretary Kennedy's leadership, HHS, CMS, and FDA have taken unprecedented steps to combat the obesity crisis and make prescriptions more affordable to everyday Americans with Most-Favored-Nation pricing. And in the coming year, the Department will continue to take steps to make medicines affordable to address and manage chronic disease.

HHS will also explore ways to enhance our nation's response to this unprecedented challenge by critically examining its regulations. To better serve the American people through its programs, HHS will advance innovative care models and other regulatory actions to prevent and manage chronic diseases, for example:

Modernization of Coverage Pathways. CMS will modernize coverage pathways for innovative technologies, streamlining implementation to ensure timely access to treatments. This rulemaking is expected to yield significant net benefits by improving health outcomes and reducing long-term costs.
Quality and Safety Measurements. CMS will reduce the number of quality measures and shift from fee-for-service to value-based care, streamlining compliance burdens and creating reimbursement pathways for MAHA-based interventions. This action will promote fiscal responsibility by optimizing resource allocation.
Substances Generally Recognized as Safe. This FDA rule proposes mandatory submission of GRAS notices, enhancing oversight of food substances to combat obesity-related risks. It promotes open government by ensuring transparent safety evaluations and is expected to yield large net benefits by reducing obesity-related health care costs.
Nutrient Content Claims for Added Sugars. FDA will propose a rule to update definitions, terminology, and provisions related to nutrient content claims and added sugars to be consistent with terms related to and updates to requirements for the Nutrition Facts label. The rule will define a new “low sugar” nutrient content claim that manufacturers could voluntarily use to communicate information about the level of added sugars in food products.
Nimbler Powered Respirators. This CDC rule will finalize performance standards allowing for the approval of PAPR100 class powered air-purifying particulate respirators. Although the current PAPR approval program has provided proven protection, these current requirements, as outlined in the interim final rule, will extend the same proven protection to smaller, lighter systems that may be more comfortable to wear.

II. Eliminating Unnecessary Administrative Expenses and Rent-Seeking Practices

Unnecessary administrative expenses and rent-seeking practices contribute to inefficiency in health care. The Department is committed to advancing initiatives that reward innovation, value, and performance.

Across the Department, under Secretary Kennedy and Deputy Secretary O'Neill's leadership, agencies are exploring, deploying, and integrating modern technology and AI to streamline internal operations of the Department and agencies. For example, HHS has launched internal tools to help employees leverage AI to streamline daily tasks; FDA has launched an AI tool to assist with scientific reviews; and CMS has launched an AI-assisted prior-authorization pilot.

The Department's regulatory priorities further reflect its commitment to eliminating unnecessary administrative burdens. In the upcoming year, HHS will take deregulatory actions to reduce common and/or significant regulatory burdens, such as:

Updating the Common Rule. The Department is considering revising 45 CFR part 46 to modernize and simplify subpart A, known as the Common Rule, to uphold protections for human subjects while reducing burden and ambiguity for investigators, institutional review boards, and research institutions. Examples of changes include clarifying terminology, expanding exemptions for certain low-risk research activities, and enabling flexibility for regulatory review of de minimis protocol changes.
Amending Regulations that Require Multiple Copies to Single Submission. FDA will replace paper-based, multiple-copy submissions with single, electronic submissions. This rule reduces paperwork burdens, saving time and costs for submitters. This action aligns with public RFI feedback calling for simplified submission processes.
Electronic Labeling for Medical Devices. FDA will propose a rule to clarify the “adequate directions for use” requirement in the Federal Food, Drug, and Cosmetic Act can be satisfied when labeling is provided solely by electronic means for certain types of devices in certain circumstances.
Ending Accreditation Monopolies. CMS will work toward reforming accreditation processes to eliminate monopolies, reduce unjustified costs, and align accreditation with principles that will make Americans healthy again. This deregulatory action promotes competition and fiscal responsibility.
Innovative Payment Models for Affordable Drugs. This CMS initiative will streamline drug pricing models, reducing government transfers and promoting fiscal responsibility, and is expected to yield large net benefits by lowering costs for patients.
Reducing Bureaucracy and Burden in the Child Care and Development Fund. This ACF proposed rule would modify Child Care and Development ( printed page 52835) Fund (CCDF) regulations to improve childcare access and choice for families, reduce administrative burdens for states, territories, and Tribes, and provide additional flexibilities by removing outdated provisions, changing requirements for Tribal CCDF programs, streamlining complicated and burdensome requirements for states and territories.
Modernizing the Head Start Program by Reducing Requirements and Enhancing Alignment with State and Local Systems. This ACF proposed rule will reduce and streamline Head Start regulatory requirements to align standards with state and local systems and reduce burden on Head Start programs. The proposed rule would also make regulatory changes to ensure children and families have access to healthy food and comprehensive nutrition services and that programs are supporting improved early literacy outcomes for children.

III. Combatting Waste, Fraud, and Abuse

Waste, fraud, and abuse are the antithesis of efficient health care. Improved technology such as AI will not only help the Department make processes more efficient, but will help root out fraud, waste, and abuse. For example, CMS's WISeR Model will assess whether new technologies like AI can expedite the prior authorization processes for select items and services that have been identified as particularly vulnerable to fraud, waste, and abuse, or inappropriate use.

In the coming year, HHS will strengthen oversight and eligibility standards with its regulatory agenda to combat fraud and reduce government transfers.

Strengthening the Integrity of Medicaid and CHIP Eligibility, Managed Care, Financing, and Section 1115 Demonstrations. By streamlining implementation through clarifying payment and access requirements, this CMS rule enhances oversight of state enrollment processes and establishes budget neutrality for Section 1115 demonstrations, reducing fraudulent transfers and ensuring fiscal responsibility.
Administrative Detention of Tobacco Products. By allowing FDA to detain adulterated or misbranded tobacco products during inspections, this rule strengthens oversight, protecting public health and reducing risks of costly recalls.
Zero-Based Regulation. The goal of this ACF proposed rule is to take the ZBR approach to ACF's regulations and remove any regulations identified as outdated or unnecessary in a cross-cutting package. This proposal seeks to trim the nearly 1,500 sections of regulations associated with ACF, some of which have not been updated since the '60s.
Eliminating Bureaucratic Waste in Federal Reporting and Assessments. This rulemaking seeks to restructure the way in which Child and Family Services Reviews are conducted by the states to comply with federal requirements. The current system is both ineffective and costly. Regulatory changes will allow for streamlined reporting and better outcomes.
Strengthening Regulatory Oversight of the Organ Procurement and Transplantation Network to Ensure Patient Safety. HRSA will make the policies of the Organ Procurement and Transplantation Network (OPTN), which are currently voluntary, legally enforceable.

IV. Protecting Religious and Individual Liberty and Standing Up for Biological Women, Children, and Families

Good health care policy begins with protecting life, liberty, and immutable, biologically rooted truths. HHS will amend regulations consistent with this policy, such as:

Making Technical Changes and Clarifying How OCR Addresses Conscience Authorities in Health Care; Delegation of Authority. This deregulatory rule clarifies federal conscience authorities, reducing ambiguity for providers and aligning with public feedback emphasizing religious liberty protections.
Restoring Flexibility to the Child Care and Development Fund. This ACF deregulatory rule increases parental choice and reduces administrative burdens in the CCDF program, streamlining implementation and supporting families. It is of particular interest to small businesses, such as childcare providers, by simplifying compliance.
Medicare; Hospital Condition of Participation: Prohibiting Sex Trait Modifications. By prohibiting specified sex trait modification procedures on children, this CMS rule enhances oversight and aligns with evidence-based care, yielding large net benefits by safeguarding child health.
Clarifying Statutory Limitation on Disability as it Applies to Gender Identity and Dysphoria in Nondiscrimination: This OCR deregulatory rule clarifies that gender identity disorders do not qualify as disabilities under Section 504, reducing unjustified burdens on providers and ensuring fiscal responsibility.
Modification of Certain Terminology in Title 21. FDA will modify certain terminology in Title 21 of the Code of Federal Regulations (CFR) to comply with Executive Order E.O. 14168, “Defending Women From Gender Ideology Extremism and Restoring Biological Truth to the Federal Government,” issued on January 20, 2025. Specifically, this proposed rule will propose removing the term “gender” wherever it appears and either replace it with the term “sex,” or delete reference to gender as applicable, along with other editorial changes to improve readability.
HIPAA Privacy Rule to Promote Individuals' Timely Access to their Protected Health Information. OCR will solicit comment on proposals to modify the Privacy Rule under the Health Insurance Portability and Accountability Act of 1996 (HIPAA) and the Health Information Technology for Economic and Clinical Health Act of 2009 (HITECH Act). The proposals would address the amount of time that covered entities have to respond to requests for protected health information (PHI) made pursuant to the right of access.

V. Radical Transparency

Radical transparency—making information, decisions, processes, and even failures publicly visible—is a force multiplier for the MAHA agenda. Radical transparency exposes impropriety, accelerates evidence-based policies, system self-correction, and ensures merit prevails in a free market. Most important, radical transparency builds trust and gives patients and care-providers the tools to make informed choices that are best for them, as opposed to having to rely on government bureaucrats. Numerous HHS agencies have already taken steps to promote radical transparency, such as FDA's release of Complete Response Letters (CRLs).

In the coming year, the Department will take other novel and unprecedented actions to promote radical transparency, including streamlining operational issues with public disclosure statutes. New regulatory actions relevant to increased transparency include:

Proactive Disclosure of Complete Response Letters. This rule will clarify and expand the FDA Commissioner's discretion to release CRLs and not approvable letters and eliminate the longstanding presumption that the mere existence of a marketing application constitutes confidential commercial information to enable proactive disclosure of information maintaining ( printed page 52836) appropriate redactions for trade secrets and personal private information.
Transparency in Direct-to-Consumer Advertising. This rule will revise 21 CFR 202.1 to eliminate the option for prescription drug advertisements broadcast through media such as radio or television to fulfill the statutory “brief summary” requirement of the Federal Food, Drug, and Cosmetic Act by disclosing risk, contraindications, and other safety information in another source beyond the advertisement itself.
Updating Privacy Act Regulations. This rule will update Department regulations at 45 CFR part 5b and remove duplicative Food and Drug Administration (FDA) Privacy Act regulations at 21 CFR part 21.
Health Data, Technology, and Interoperability: Application Programming Interfaces and Information Blocking Advancements. ASTP will propose a rule to advance interoperability through API certification and updated information blocking regulations, promoting open government by enhancing data sharing and improved patient outcomes.
Reforming the HHS Petition Process. HHS will put forward new streamlined procedures for handling rulemaking petitions, including a process to review existing regulations.

VI. Conclusion

In the coming year, HHS will take regulatory actions to further the MAHA agenda and reduce burdens and costs while maximizing benefits and transparency. To fully realize the potential of these efforts, HHS seeks to collaborate with stakeholders and the public to ensure concerns are given due consideration and properly and transparently addressed. By working with stakeholders and the public, the Department hopes to Make America Healthy Again, ensure regulations better serve the needs of the American people, and restore confidence in our public health agencies.

HHS—Office of the Secretary (OS)	Proposed Rule Stage

38. PRIVACY ACT REGULATIONS

Priority: Other Significant

Regulatory Accounting: Not subject to, not significant

Legal Authority: 5 U.S.C. 552a(f)

Relevant Executive Orders: 14243; 14291; 14295

CFR Citation: 45 CFR part 5b

Legal Deadline: None

Abstract: This rulemaking will update the Department's Privacy Act regulations at 45 CFR part 5b, which detail how the Department implements requirements of the Privacy Act of 1974, as amended (5 U.S.C. 552a), and will remove duplicative Food and Drug Administration (FDA) Privacy Act regulations at 21 CFR part 21.

Statement of Need: The Department's existing regulations were promulgated in 1975, when the Privacy Act was new. Certain details are now outdated, incomplete, or incorrect due to later amendments to the Privacy Act, statutorily mandated organizational changes, and judicial interpretations. The proposed amendment would result in significant changes and improvements to the Department's regulations (for example, it would remove antiquated provisions that require an individual's medical records to be released to the individual indirectly, through a doctor or other representative designated by the individual), and it would enable the separate FDA Privacy Act regulations to be removed as duplicative.

Summary of Legal Basis: The Privacy Act statute at 5 U.S.C. 552a(f) requires each agency to maintain up-to-date rules implementing the Privacy Act. Based on the definition of agency in the Freedom of Information Act (FOIA) statute at 5 U.S.C. 552(f)(1) (formerly 5 U.S.C. 552(e)), which is incorporated in the Privacy Act statute at 5 U.S.C. 552a(a)(1), such rules must be maintained at the Departmental level but are not required at the sub-agency level.

Alternatives: Leaving the regulations in their current state is not recommended, because certain details in the regulations are outdated, incomplete, or incorrect, and some required provisions are missing. For example, court cases have identified legal deficiencies in indirect-access-to-medical records provisions like those in the Department's regulations, effectively rendering those provisions unenforceable in their current state.

Anticipated Cost and Benefits: The proposed rule is not significant for purposes of E.O. 12866. Privacy Act regulations do not apply to businesses or other entities and do not impose significant costs and burdens on individuals

Risks: The only risk that we perceive is associated with eliminating the indirect-access-to-medical-records provisions, i.e., that harm to the individual or another person could result from allowing subject individuals to receive direct access to their medical records under the Privacy Act. However, that same risk is present now, because the indirect access provisions are effectively unenforceable in their current state, and the risk would be present if the provisions were retained with curative provisions added, as the curative provisions would guarantee the full disclosure to the individual of any medical record the agency released to the individual's designated representative.

Timetable:

Action	Date	FR Cite
NPRM	07/00/26

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Samuel Shipley, Team Lead & Senior Regulatory Coordinator, Department of Health and Human Services, Office of the Secretary, 200 Independence Avenue SW, Washington, DC 20201

Phone: 202 503-6492

Email: samuel.shipley@hhs.gov

RIN: 0991-AC05

HHS—OS	Final Rule Stage

39. • PETITION PROCESS FOR RULEMAKING AND REGULATORY REVIEW

Priority: Other Significant

Regulatory Accounting: Deregulatory

Unfunded Mandates: Undetermined

Legal Authority: 5 U.S.C. 553(e), 610

Relevant Executive Orders: 14217; 14219; 14270

CFR Citation: 45 CFR part 10

Legal Deadline: None

Abstract: This final rule establishes new procedures for the submission, processing, and review of petitions to amend or repeal a rule under 5 U.S.C. 553(e) and for regulatory review under 5 U.S.C. 610(b).

Statement of Need: This regulatory action will lessen the burden on both the public and agency to respond to rulemaking petitions and establish a process for regulatory review of existing regulations. Existing processes often result in delays and the presentation of non-standard or incomplete submissions. This regulatory action will also enhance transparency and public trust in the rulemaking process.

Summary of Legal Basis: TBD

Alternatives: TBD

Anticipated Cost and Benefits: The costs and benefits are difficult to quantify. It is anticipated that this rulemaking will require upfront costs to set up technology to receive and efficiently process rulemaking petitions. Once the rule is set up, it is anticipated ( printed page 52837) that recurring costs will be minimal and the benefits of less employee time spent managing rulemaking petitions will outstrip costs.

Risks: TBD

Timetable:

Action	Date	FR Cite
Interim Final Rule	07/00/26

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Matt Zorn, Deputy General Counsel, Department of Health and Human Services, Office of the Secretary, 200 Independence Avenue SW, Washington, DC 20201

Phone: 202 555-1234

Email: matthew.zorn@hhs.gov

RIN: 0991-AC43

HHS—Office for Civil Rights (OCR)	Proposed Rule Stage

40. MAKING TECHNICAL CHANGES AND CLARIFYING HOW OCR ADDRESSES CONSCIENCE AUTHORITIES IN HEALTH CARE; DELEGATION OF AUTHORITY (RULEMAKING RESULTING FROM A SECTION 610 REVIEW)

Priority: Other Significant

Regulatory Accounting: Regulatory

Legal Authority: 5 U.S.C. 301 and other federal authorities

Relevant Executive Orders: 14219; 14202; 14188

CFR Citation: 45 CFR 88

Legal Deadline: None

Abstract: In keeping with Executive Orders 14202 and 14188, and HHS' commitment to reevaluate its regulations and guidance pertaining to Federal laws on conscience and religious exercise, the proposed conscience rule would amend the 2024 rule to make technical corrections and clarify how OCR addresses those federal authorities.

Statement of Need: HHS is the Federal government's lead agency for protecting the health of all Americans and providing essential human services. OCR supports that mission by ensuring HHS programs and funds are expended in keeping with applicable civil rights laws, including laws protecting the conscience rights of the health care workforce. Current OCR regulations provide clarity on OCR's enforcement process but do not address the scope and meaning of the federal health care conscience statutes. Prior rulemakings have received significant stakeholder engagement requesting clarity on these authorities. This regulatory action is needed to clarify that scope and meaning to ensure the health care workforce can avail themselves of their protection, thereby ensuring their ability to continue providing health care, including in the service of women, children, and families.

Summary of Legal Basis: This regulation would be promulgated under federal conscience and religious freedom protections such as the following authorities: The Federal health care conscience statutes ( e.g.,42 U.S.C. 300a-7 (the Church Amendments); 42 U.S.C. 238n (Coats-Snowe Amendment); the Weldon Amendment ( e.g.,Pub. L. 115-245, Div. B, sec. 507(d)). The authorities include the Department's Housekeeping Authority (5 U.S.C. 301); 40 U.S.C. 121(c); 42 U.S.C. 263a(f)(1)(E); Uniform Administrative Requirements, Cost Principles, and Audit Requirements For HHS Awards (45 CFR parts 75 and 96); Federal Acquisitions Regulations (48 CFR chapter 1; 48 CFR part 370); HHS Nonprocurement Debarment And Suspension (2 CFR part 376).

Alternatives: OCR will consider as alternative approaches to the proposed rulemaking:

A. Not engaging in rulemaking and maintaining the status quo.

B. Engaging in technical rulemaking only to add related authorities to OCR's delegation to enforce the federal health care conscience statutes and to clarify portions of the current regulation.

C. Promulgating a rule substantially similar in scope and cost to the 2019 Final Conscience Rule.

Anticipated Cost and Benefits: The 2024 Final Conscience Rule had significant quantifiable savings of −$128,000,000 annualized value for the 7% discount rate as a result from partly repealing the 2019 conscience rule. This regulatory action would be building on that final rule to confer non-quantifiable benefits such as notice and greater clarity for the medical community about existing statutory obligations and protections. This regulatory action would also confer qualitative benefits, including sustaining membership in the workforce of practitioners who would otherwise not join or remain in the workforce but for protection of their statutory conscience rights. This regulatory action would address Government and other federally funded discrimination against health care systems, insurers, providers, and the like could reduce the private health care workforce, and in turn, this could result in longer wait times, lower quality of care, and more people accessing government funded health insurance with greater costs to the public.

This regulatory action would likely incur some quantifiable costs associated with ensuring compliance with the federal health care conscience statutes. Similar to the 2019 and 2024 Final Conscience Rules, this regulatory action is likely to have familiarization costs similar to the $106.3 million cost (at a 7% discount) in the 2024 Final Rule and $103 million cost (at a 7% discount) in the 2019 Final Rule. The familiarization costs in this rule will be adjusted for inflation and will occur in the first year after publication. This regulatory action may prompt covered entities to incur voluntary remedial efforts, at a similar inflation-adjusted cost to the 2019 Rule, which costs ranged between $8.0 million and $5.4 million annually (at a 7% discount rate). Other costs associated with the 2019 Final Rule, including additional enforcement costs to OCR and the cost of voluntary notices, were not considered new costs under the 2024 Final Rule. OCR does not anticipate additional costs associated with voluntary notices, however, there may be additional modest enforcement costs to OCR at less than $3 million a year.

Risks: This regulation may reduce risks to public health by reducing instances of conscience-based discrimination. This both prevents the deleterious impact discrimination can have on the individuals experiencing the discrimination, and the negative impact on public health of a reduction in work force membership, including in rural areas, of practitioners who would otherwise not join or remain in the workforce but for awareness of and clear protection of their statutory conscience rights. The magnitude of the risk addressed by the action is similar to OCR's role in mitigating risks to public health posed by discrimination on other bases, though allegations of conscience-based discrimination currently constitute a smaller portion of the discrimination-based complaints received annually by OCR.

Timetable:

Action	Date	FR Cite
NPRM	07/00/26

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: David Christensen, Supervisory Policy Advisor, Department of Health and Human Services, Office for Civil Rights, 200 Independence Avenue SW, Washington, DC 20201

Phone: 202 795-7830

Email: consciencerule@hhs.gov ( printed page 52838)

Related RIN: Previously reported as 0945-AA18

RIN: 0945-AA24

HHS—OCR	Final Rule Stage

41. HIPAA PRIVACY RULE: CHANGES TO SUPPORT COORDINATED CARE AND INDIVIDUAL ENGAGEMENT AND REDUCE REGULATORY BURDENS

Priority: Other Significant. Major under 5 U.S.C. 801.

Regulatory Accounting: Deregulatory

Unfunded Mandates: This action may affect the private sector under PL 104-4.

Legal Authority: Health Insurance Portability and Accountability Act of 1996 (HIPAA), sec. 264 (42 U.S.C. 1320d-2 note); Health Information Technology for Economic and Clinical Health (HITECH) Act, sec. 13405 (42 U.S.C. 201 note)

Relevant Executive Orders: 14219; 13610; 13563; 14221

CFR Citation: 45 CFR 160; 45 CFR 164

Legal Deadline: None

Abstract: This rule will address proposals to modify the HIPAA Privacy Rule to strengthen individuals' rights to access their own protected health information, including electronic information; improve information sharing for care coordination and case management for individuals; facilitate greater family and caregiver involvement in the care of individuals experiencing emergencies or health crises; enhance flexibilities for disclosures in emergency or threatening circumstances; support the use of telecommunications relay services by individuals and workforce members of HIPAA covered entities and business associates who are deaf, hard of hearing, deaf-blind, or who have a speech disability; expand the Privacy Rule permission to use and disclose protected health information of Armed Forces personnel for national readiness purposes so that it applies to all uniformed services personnel; and reduce administrative burdens on HIPAA covered health care providers and health plans, while continuing to protect individuals' health information privacy interests.

Statement of Need: HHS is the Federal government's lead agency for protecting the health of all Americans and providing essential human services. OCR supports that mission by enforcing protections for health information privacy and security pursuant to the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy, Security, and Breach Notification Rules and the Health Information Technology for Economic and Clinical Health Act of 2009 (HITECH Act). In light of ongoing concerns that regulatory barriers across the Department impede effective delivery of coordinated, value-based health care, and impose unnecessary administrative expenses and limit initiatives that reward innovation, value, and performance, the Department launched efforts to promote care coordination and facilitate a nationwide transformation to value-based health care and reduce regulatory barriers to coordinated care.

Summary of Legal Basis: This regulation would be promulgated under HIPAA, the HITECH Act.

Alternatives: OCR considered regulatory and non-regulatory alternatives to rulemaking, including expanding OCR outreach, guidance, and educational materials, as well as not engaging in rulemaking and maintaining the status quo. OCR determined that rulemaking is necessary to achieve the desired effects of reducing burdens and strengthening individual rights. OCR may supplement this rulemaking with non-regulatory actions such as issuing subregulatory guidance.

Anticipated Cost and Benefits: OCR estimates an annualized cost savings of approximately $785 million discounted at 7 percent. Costs are attributable to new training, the development of new policies and procedures, and administrative expenses. Cost-savings are attributable to eliminating certain recordkeeping requirements.

Risks: None known.

Timetable:

Action	Date	FR Cite
RFI	11/01/18	83 FR 64302
RFI Comment Period End	02/19/19
NPRM	01/21/21	86 FR 6446
NPRM Comment Period Extended	03/10/21	86 FR 13683
NPRM Comment Period End	03/22/21
NPRM Comment Period Extended End	05/06/21
Final Action	08/00/26

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Federal, Local, State, Tribal

URL For More Information: www.hhs.gov/ocr/privacy

Agency Contact: Conner O'Brien, Senior Advisor, Department of Health and Human Services, Office for Civil Rights, 200 Independence Avenue SW, Washington, DC 20201

Phone: 800 537-7697

Email: conner.obrien@hhs.gov

Related RIN: Related to 0945-AA20

RIN: 0945-AA00

HHS—OCR

42. NONDISCRIMINATION ON THE BASIS OF DISABILITY IN PROGRAMS OR ACTIVITIES RECEIVING FEDERAL FINANCIAL ASSISTANCE

Priority: Other Significant

Regulatory Accounting: Deregulatory

Legal Authority: 29 U.S.C. 794

Relevant Executive Orders: 14219; 14168; 14187

CFR Citation: 45 CFR 84

Legal Deadline: None

Abstract: This proposed rule would revise 45 CFR part 84 under section 504 of the Rehabilitation Act of 1973 to address discrimination on the basis of disability in programs and activities funded by HHS. HHS revised 45 CFR part 84 under Section 504 in May of 2024 (see Nondiscrimination on the Basis of Disability in Programs or Activities Receiving Federal Financial Assistance (RIN 0945-AA15)) and now intends to clarify existing statutory limitations on the definition of disability as it applies to gender identity disorders and/or gender dysphoria.

Statement of Need: In order to further this Administration's priorities and clear up confusion surrounding non-binding preamble language, HHS will need to issue rulemaking on disability under Section 504. HHS has issued a Federal Register notice that the preamble statements lack the force and effect of law and are not enforceable. See Nondiscrimination on the Basis of Disability in Programs or Activities Receiving Federal Financial Assistance; Clarification, 90 FR 15412 (Apr. 11, 2025). However, because preamble discussions are often persuasive authority, HHS needs to issue a rule clarifying that the 2024 Section 504 Final Rule preamble language on gender dysphoria did not constitute the best reading of 29 U.S.C. 705(20)(F)(i) which excludes gender identity disorders from the term disability. The Department has already faced legal consequences [1] for the language and will need to clear up confusion among recipients and members of the public. Regulatory action is needed to address litigation, enforce the Administration's priorities, and recognize the best reading of the underlying statute.

[1] See Texas v. Becerra, No. 5:24-cv-00225 (N.D. Tex.); Rapides Parish Sch. Bd. v. U.S. Dep't of Health & Hum. Servs., et al, 1:25-cv-70 (W.D. La.). ( printed page 52839)

Summary of Legal Basis: Section 504 of the Rehabilitation Act of 1973, as amended, 29 U.S.C. 794, gives HHS the authority to promulgate regulations prohibiting discrimination on the basis of disability in programs and activities conducted by the Department. The substantive authority for the definition and exclusions includes 29 U.S.C. 705 (20)(F) There are currently no requirements due to statute or court order.

Alternatives: OCR will consider as alternative approaches to the proposed rulemaking:

A. Not engaging in rulemaking and maintaining the status quo.

B. Attempt an Interim Final Rule (IFR) instead of a Notice of Proposed Rulemaking (NPRM).

Anticipated Cost and Benefits: Any costs would be negligible given that this is a clarification of one limited aspect of the definition of disability as it relates to bringing claims for civil rights violations. OCR does not anticipate that recipients will alter their practices based on this clarification, especially since this clarification will eliminate any confusion that may have been brought about by the Preamble to 2024 Section 504 Final Rule. Benefits would be largely unquantifiable and rest largely on enforcing Administration priorities.

Risks: The main risk is for further litigation. At present, there is only a single federal appeals court decision, Williams v. Kincaid, [1] that addresses, on the merits, whether gender dysphoria may be considered a disability under the Americans with Disabilities Act (ADA) and Section 504 of the Rehabilitation Act. That decision comes to the opposite conclusion of this rulemaking, finding that gender dysphoria is not sufficiently similar to gender identity disorders, which are expressly excluded from the definition of disability and individual with a disability under the ADA and/or Section 504. While many district courts have come to the opposite conclusion of Williams, and OCR believes that the best reading of the underlying statute essentially is that gender identity disorder encompasses gender dysphoria, the Fourth Circuit opinion cuts against this rulemaking. OCR's approach is consistent with a recent statement of interest filed by the Department of Justice in a private lawsuit involving an ADA claim on the same issue.

[1] 45 F.4th 759 (4th Cir. 2022), cert. denied, 600 U.S. __ (2023).

Timetable:

Action	Date	FR Cite
NPRM	12/19/25	90 FR 59478
NPRM Reopening of public comment period	02/02/26	91 FR 4467
NPRM Comment Period End	02/20/26
Final Action	09/00/26

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: John Thompson, Policy Advisor, Policy Division, Department of Health and Human Services, Office for Civil Rights, 200 Independence Avenue SW, Washington, DC 20201

Phone: 800 368-1019

TDD Phone: 800 537-7697

Email: 504@hhs.gov

Related RIN: Previously reported as 0945-AA15

RIN: 0945-AA27

HHS—Office of the National Coordinator for Health Information Technology (ONC)	Proposed Rule Stage

43. • HEALTH DATA, TECHNOLOGY, AND INTEROPERABILITY: APPLICATION PROGRAMMING INTERFACES AND INFORMATION BLOCKING

Priority: Economically Significant. Major status under 5 U.S.C. 801 is undetermined.

Regulatory Accounting: Regulatory

Unfunded Mandates: Undetermined

Legal Authority: 42 U.S.C. 300jj-11; 42 U.S.C. 300jj-14; 42 U.S.C. 300jj-52; 5 U.S.C. 552; P.L 114-255

Relevant Executive Orders: 14267; 14221; 14212

CFR Citation: 45 CFR 170; 45 CFR 171

Legal Deadline: None

Abstract: The proposed rule would seek to advance interoperability through proposals for standards adoption; the certification of health IT to support expanded uses of application programming interfaces (APIs); and enhancements to the conditions of certification. Additionally, the rule would update the information blocking regulations to support information sharing and improved patient health outcomes.

Statement of Need: The Make America Healthy Again initiative, as established by Executive Orders 14212 Establishing the President's Make America Healthy Again Commission and 14221 Making America Healthy Again by Empowering Patients with Clear, Accurate, and Actionable Healthcare Pricing Information, aims to combat chronic disease and enhance price transparency. Executive Order 14267, Reducing Anti-Competitive Regulatory Barriers, further promotes market competition and lowering health care costs. The HTI-6 Proposed Rule is needed to further enhance the access, exchange, and use of electronic health information (EHI) by patients, providers, and third parties—empowering them to address chronic disease, increase market competition, and lower health care costs. Specifically, proposals in the rule would advance interoperability and EHI sharing through: standards adoption; the certification of health IT to support expanded uses of application programming interfaces (APIs) and potential successor technologies; targeted conditions of certification; and revised information blocking regulations.

Summary of Legal Basis: The provisions would be implemented under the authority of the Public Health Service Act, as amended by the HITECH Act and the 21st Century Cures Act.

Alternatives: ONC will consider different options to improve interoperability and access to electronic health information so that the benefits to providers, patients, and payers are maximized and the economic burden to health IT developers, providers, and other stakeholders is minimized.

Anticipated Cost and Benefits: The majority of costs for this proposed rule would be incurred by health IT developers in terms of meeting new requirements and continual compliance with the condition and maintenance of certification requirements. We expect that through implementation and compliance with the regulations, the market (particularly patients, payers, and providers) will benefit greatly from increased interoperability and access to electronic heath information. We have not yet quantified the costs and benefits of this proposed rule.

Risks: At this time, ASTP/ONC has not been able to identify any substantial risks that would undermine likely proposals in the proposed rule.

Timetable:

Action	Date	FR Cite
NPRM	11/00/26

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected: Businesses

Government Levels Affected: Undetermined

Agency Contact: Michael Lipinski, Director, Regulatory and Policy Affairs Division, Office of Policy, Department of ( printed page 52840) Health and Human Services, Office of the National Coordinator for Health Information Technology, Mail Stop: 7033A, 330 C Street SW, Washington, DC 20201

Phone: 202 690-7151

Email: michael.lipinski@hhs.gov

RIN: 0955-AA10

HHS—Centers for Disease Control and Prevention (CDC)	Proposed Rule Stage

44. CONTROL OF COMMUNICABLE DISEASES; FOREIGN QUARANTINE: DOG IMPORTATION

Priority: Other Significant

Regulatory Accounting: Deregulatory

Legal Authority: 42 U.S.C. 264, sec. 361

Relevant Executive Orders: 14219; 14165; 14243

CFR Citation: 42 CFR 71

Legal Deadline: None

Abstract: This proposed rule addresses the public health risk of dog-maintained rabies virus variant (DMRVV) associated with the importation of dogs into the United States. In this rule, HHS/CDC proposes revisions and clarifications to the requirements for the importation of dogs.

Statement of Need: Following publication of a related final rule in May 2024, CDC received considerable feedback regarding the rule's requirements for dogs entering from low risk and rabies-free countries. In response, CDC quickly implemented temporary flexibilities prior to the rule's effective date. Implementing these temporary flexibilities alleviated the most pressing concerns regarding burden and prevented travel disruptions.

Targeted modification of these regulatory requirements is needed to ensure that they are proportionate to the public health risk. By refining these requirements, we can strike a better balance between protecting public health and minimizing unnecessary burden importers from low-risk and rabies-free countries. This approach acknowledges a minimal increase in the possibility of fraudulent importation, but the benefits are substantial: improved public compliance, streamlined processes, and significantly reduced burden for those importing dogs from the lowest-risk countries. In addition to alleviating the burden of individuals importing dogs, we are also working closely with airlines to provide additional flexibilities for air waybill requirements.

Congressional and interagency partners (including Department of State), foreign governments, airlines, rescue groups, disability advocates, and breeders have welcomed the temporary flexibilities and remain interested in maintaining simpler and less burdensome importation requirements in the long-term.

Summary of Legal Basis: The primary legal authority supporting this proposed rule is section 361 of the Public Health Service Act (PHS Act) (42 U.S.C. 264). Under section 361, the Secretary of HHS (Secretary) may make and enforce such regulations as in the Secretary's judgment are necessary to prevent the introduction, transmission, or spread of communicable diseases from foreign countries into the United States and from one State or possession into any other State or possession. It also authorizes the Secretary to promulgate and enforce a variety of public health regulations to prevent the spread of communicable diseases, including through inspection, fumigation, disinfection, sanitation, pest extermination, destruction of animals or articles found to be sources of dangerous infection to human beings, and other measures. Since at least 1956, federal quarantine regulations (currently found at 42 CFR 71.51) have controlled the entry of dogs and cats into the United States.

Alternatives: We have considered maintaining existing dog importation requirements, which would provide the highest level of protection against the importation of DRMVV. However, we have determined that reducing the requirements for low-risk dog importations would substantially lower burden while retaining appropriate public health protections. This approach aligns with Section 4(c)(1)(B) of Executive Order 12866, which calls for regulations to be tailored to the level of risk and to avoid imposing unnecessary costs. Furthermore, maintaining current requirements would conflict with the mandate in Executive Order 14219 to reduce regulatory burdens wherever possible.

Anticipated Cost and Benefits: While formal economic estimates are still in progress, CDC's preliminary analysis indicates that the proposed revisions to 42 CFR 71.51 will generate substantial cost savings and increased flexibilities for individual travelers, government agencies, and commercial airlines. Current estimates suggest that these changes could result in annualizednet cost-savings of $5--$43 million.

The primary source of cost savings stems from streamlining documentation requirements for dogs imported from rabies-free and low-risk countries. By streamlining these requirements, the rule will significantly reduce administrative, compliance, and processing costs for importers. Instead, the only requirement will be a CDC Dog Import Form receipt.

In addition to the cost-savings, the proposed changes will enhance travel flexibility for individuals and organizations, making it easier to import dogs from low-risk countries without unnecessary delays or disruptions.

Risks: Adopting reduced documentation requirements for dogs imported from low-risk and rabies-free countries is a targeted approach that aligns regulatory oversight with the public health risk posed by these importations. The primary risk associated with this approach is a small increase in the possibility of fraudulent importation attempts, such as falsified documentation or misrepresentation of a dog's country of origin or rabies status. However, this risk is mitigated by several factors:

5. Low Baseline Risk: Dogs imported from countries classified as low-risk or rabies-free have a minimal likelihood of carrying DMRVV, as these countries maintain robust rabies control and surveillance programs. Historical data and international standards support the low risk associated with these importations.

Retained Safeguards: While documentation requirements are being streamlined, essential safeguards remain in place to verify the origin and health status of imported dogs. These measures continue to provide a strong layer of protection against the introduction of rabies and other diseases.The proposed rule would maintain the Director's authority to deny the entry of dogs who do not appear healthy upon arrival.

4. Improved Compliance: Simplifying requirements is expected to increase public compliance, as importers are more likely to follow clear and reasonable rules. Higher compliance rates further reduce the risk of inadvertent or intentional violations.

This approach is consistent with Section 4(c)(1)(D) of Executive Order 12866, which directs agencies to ensure that regulations are proportionate to the risks addressed. By focusing regulatory efforts where they are most needed, we maintain effective public health protections while minimizing unnecessary burdens.

Timetable:

Action	Date	FR Cite
NPRM	07/00/26

Regulatory Flexibility Analysis Required: Undetermined ( printed page 52841)

Small Entities Affected: Businesses, Organizations

Government Levels Affected: Federal, Local, State

International Impacts: This regulatory action will be likely to have international trade and investment effects, or otherwise be of international interest.

Agency Contact: Ashley C. Altenburger, JD, Regulatory Analyst, Department of Health and Human Services, Centers for Disease Control and Prevention, 1600 Clifton Road NE, MS: H16-4, Atlanta, GA 30307

Phone: 800 232-4636

Email: dgmqpolicyoffice@cdc.gov

RIN: 0920-AA87

HHS—Food and Drug Administration (FDA)	Proposed Rule Stage

45. ADMINISTRATIVE DETENTION OF TOBACCO PRODUCTS

Priority: Other Significant

Regulatory Accounting: Regulatory

Legal Authority: 21 U.S.C. 334; 21 U.S.C. 371

Relevant Executive Orders: 14212; 14303; 13563

CFR Citation: 21 CFR 16; 21 CFR 1100

Legal Deadline: None

Abstract: FDA is proposing a regulation to establish requirements for the administrative detention of tobacco products. This rule, if finalized, would allow FDA to administratively detain tobacco products believed to be adulterated or misbranded that are encountered during inspections of manufacturers, vape shops, or other establishments that manufacture, process, pack, or hold tobacco products. The intent of administrative detention is to protect public health by preventing the distribution or use of tobacco products that are believed to be adulterated or misbranded until FDA has had time to consider the appropriate action to take and, where appropriate, to initiate legal action. This rule, if finalized, would be a critical enforcement tool to stop the distribution and sale of unauthorized tobacco products, such as illegal shipments of unauthorized e-cigarettes originating from overseas.

Statement of Need: Currently, Federal law prohibits the adulteration or misbranding of a tobacco product, as well as the introduction, delivery for introduction, or receipt in interstate commerce of such product. Adulterated products include those that are contaminated, held under unsanitary conditions, or lack required marketing authorization. (Section 902(1)-(2), (6) of the Federal Food, Drug, and Cosmetic Act (FD&C Act). Misbranded products include those with false or misleading labeling or those that do not bear labeling that is required by an applicable tobacco product standard. (Section 903(a)(1) and (a)(9) of the FD&C Act.) Notably, large quantities of tobacco products such as e-cigarettes continue to be illegally imported and marketed without required marketing authorization. This proposed rule, if finalized, would allow FDA to administratively detain non-compliant tobacco products. The period of administrative detention provides FDA with valuable time to consider further action, if appropriate, including time to engage the Department of Justice, who could go to court on FDA's behalf to pursue legal action such as a seizure of the products in question. Without the ability to administratively detain non-compliant products, manufacturers, distributors, and retailers could unlawfully transport the products to evade their seizure, and market them from a different location.

This proposed rule mirrors existing regulatory authority for the administrative detention of devices and drugs. FDA's administrative detention authority with respect to drugs allows FDA to better protect the integrity of the drug supply chain. For foods, FDA can exercise administrative detention authority to prevent potentially harmful food from reaching U.S. consumers and thereby improve the safety of the U.S. food supply. Similarly, FDA can administratively detain devices that are suspected of being in violation of the Act. This proposed rule is needed with respect to tobacco products so that FDA has an additional enforcement tool to better protect the public health. The ability for FDA to issue administration detention orders against new, unauthorized tobacco products, including ENDS, may encourage manufacturers to submit premarket applications requesting authorization for their products to be lawfully marketed, rather than continue to flood the market with additional unauthorized products. FDA would be able to use our resources to review these applications under streamlined procedures under development and authorize those that are appropriate for the protection of the public health.

Summary of Legal Basis: The legal basis for this action is sections 304(g) and 701 of the Federal Food, Drug, and Cosmetic Act (FD&C Act). Section 304(g) of the FD&C Act provides FDA with administrative detention authority with respect to tobacco products pursuant to duly promulgated regulations. Section 304(g)(1) states that [i]f during an inspection conducted under section 704 of a facility or a vehicle, a device, drug, or tobacco product which the officer or employee making the inspection has reason to believe is adulterated or misbranded is found in such facility or vehicle, such officer or employee may order the device, drug, or tobacco product detained (in accordance with regulations prescribed by the Secretary) for a reasonable period which may not exceed twenty days unless the Secretary determines that a period of detention greater than twenty days is required to institute an action under subsection (a) or section 302, in which case he may authorize a detention period of not to exceed thirty days. Additionally, section 701 of the FD&C Act gives FDA general rulemaking authority to issue regulations for the efficient enforcement of the FD&C Act.

Alternatives: FDA has considered a delay in the effective date of the regulation, i.e., a greater than 30-day period before the rule becomes effective. While a delay may discount FDA's cost estimates, it would not have an impact on the cost of regulated entities reading and understanding the rule. On the other hand, a delay in the effective date would increase the risk of adulterated or misbranded tobacco products being released into U.S. commerce and to the public. For these reasons, FDA did not pursue this regulatory alternative.

Anticipated Cost and Benefits: The estimated primary costs of the proposed rule include the one-time costs incurred by industry to read and understand the regulation, if finalized, annual costs to FDA associated with marking or labeling the detained product, and costs associated with potential appeals of detention orders; however, other costs, such as loss in market value of a detained tobacco product or additional costs associated with appeals of detention orders to affected entities, could be incurred if FDA revokes the detention order on appeal. Given the history of administrative detention use with medical devices, foods, and human and animal drugs, the most likely outcomes are the firm would choose to destroy the detained tobacco product voluntarily or that FDA would initiate a seizure of the product.

The primary public health benefit from adoption of the proposed rule would be the value of the illnesses, injuries, or deaths prevented because the Agency administratively detained a tobacco product it has reason to believe is adulterated or misbranded. These benefits would occur only if the tobacco product would not have been prevented ( printed page 52842) from entering the market using one of the Agency's other regulatory and enforcement tools. Additionally, should firms choose to voluntarily destroy the detained tobacco products, or a federal seizure action is otherwise avoided, potential cost-savings would be realized. There would also be benefits from deterrence if administrative detention increases the likelihood that adulterated or misbranded products would not enter commerce in the future.

Risks: None.

Timetable:

Action	Date	FR Cite
NPRM	07/00/26

Regulatory Flexibility Analysis Required: No

Government Levels Affected: Federal

Agency Contact: Dhanya John, Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, Center for Tobacco Products, 10903 New Hampshire Avenue, Document Control Center, Bldg. 71, Rm. G335, Silver Spring, MD 20993

Phone: 877 287-1373

Email: askctp@fda.hhs.gov

Beth Buckler, Senior Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, Center for Tobacco Products, 10903 New Hampshire Avenue, Document Control Center, Bldg. 71, Rm. G335, Silver Spring, MD 20993

Phone: 877 287-1373

Email: askctp@fda.hhs.gov

RIN: 0910-AI05

HHS—FDA

46. MODERNIZING REGULATIONS TO PROMOTE ELECTRONIC SUBMISSION AND REDUCE PAPER SUBMISSION

Priority: Other Significant

Regulatory Accounting: Deregulatory

Legal Authority: 5 U.S.C. 551 to 558; 5 U.S.C. 701 to 706; 15 U.S.C. 1453; 15 U.S.C. 1454; 15 U.S.C. 1455; 21 U.S.C. 141 to 149; 21 U.S.C. 321; 21 U.S.C. 331; 21 U.S.C. 336; 21 U.S.C. 341; 21 U.S.C. 342; 21 U.S.C. 343; 21 U.S.C. 348; 21 U.S.C. 351; 21 U.S.C. 352; 21 U.S.C. 353; 21 U.S.C. 355; 21 U.S.C. 360; 21 U.S.C. 360c; 21 U.S.C. 360j; 21 U.S.C. 360l; 21 U.S.C. 360aa; 21 U.S.C. 360aaa-6; 21 U.S.C. 360b-360f; 21 U.S.C. 360bbb-8b; 21 U.S.C. 360h to 360i; 21 U.S.C. 361; 21 U.S.C. 371; 21 U.S.C. 372; 21 U.S.C. 373; 21 U.S.C. 374; 21 U.S.C. 375; 21 U.S.C. 379; 21 U.S.C. 379e; 21 U.S.C. 379k-1; 21 U.S.C. 381; 21 U.S.C. 467f; 21 U.S.C. 679; 21 U.S.C. 821; 21 U.S.C. 1034; 28 U.S.C. 2112; 42 U.S.C. 201; 42 U.S.C. 216; 42 U.S.C. 241; 42 U.S.C. 243; 42 U.S.C. 262; 42 U.S.C. 263b; 42 U.S.C. 264; 42 U.S.C. 271; . . .

Relevant Executive Orders: 14303; 13563; 14212

CFR Citation: 21 CFR 101.69; 21 CFR 130.17; 21 CFR 171.1; 21 CFR 571.1; 21 CFR 71.1; 21 CFR 10.20; 21 CFR 10.40; 21 CFR 10.85; 21 CFR 314.94; 21 CFR 314.50

Legal Deadline: NPRM, Statutory, September 30, 2022.

Abstract: This rule would amend FDA's regulations to promote electronic submissions and reduce paper submission, including by removing requirements for submission of multiple copies and replace them with the requirement for a single submission in electronic format. This action is being undertaken to revise regulations that required paper submission.

Statement of Need: The proposed rule, if finalized, would remove express or implied requirements for submission of multiple copies as well as the requirement or option to provide paper submissions for a large number of programs and processes administered by the Agency and replace them with a requirement for single submissions in electronic format. Because electronic submission is easily reproducible, the requirement for multiple copies is no longer necessary. FDA believes it is beneficial to the public to limit any burden and expense to submitters caused by requiring additional copies, and that due to the essentially universal availability of electronic devices that can transmit documents in electronic format, the Agency no longer needs to provide the option to submit information on paper. In conjunction with related efforts focused on existing records, this rule would facilitate a fully digital system of records submitted to and maintained by the Agency. FDA considers that such a system would enhance the efficiency of the Agency's operations and also facilitate transparency in records requests. To help ensure access to FDA's submission processes for all participants, the Agency intends to provide the ability to request a waiver for individual paper submissions.

Summary of Legal Basis: FDA is issuing this rule from the same authority under which FDA initially issued the applicable regulations. In addition, section 701(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 371(a)) grants FDA general rulemaking authority to issue regulations for the efficient enforcement of the FD&C Act.

Alternatives:

Alternative 1: Remove express or implied requirements for paper submissions but continue to accept them if submitted.

Given the availability of a waiver process, the primary beneficiaries of this option would be entities with the ability or option to submit electronically but who do not choose to do so. Compared to the proposed approach, this option would be less effective at reducing administrative complexity and system fragmentation going forward and would reduce the accessibility of Agency records.

Alternative 2: Require electronic submissions only for a subset of submission processes.

This option would involve selecting certain submission processes for mandatory electronic submission. As with Alternative 1, we anticipate this option would be less effective at reducing administrative complexity and system fragmentation going forward and would reduce the accessibility of Agency records. In addition, this approach could potentially result in concerns of unbalanced treatment of different stakeholders or industry sectors based on the selected processes.

Anticipated Cost and Benefits: The rule would amend regulations to reduce or eliminate submitting multiple copies to the Agency for a large number of programs and processes. The rule would also amend regulations containing a reference to the specific form of a submission to require that the submission be in electronic format. The rule would produce cost-savings for firms and FDA without imposing any additional regulatory burdens or affecting the Agency's ability to review submissions. Firms would incur minimal administrative costs to read and understand the rule. Some firms and individuals that currently send their submissions by mail may incur the costs of submit electronically.

Risks: TBD

Timetable:

Action	Date	FR Cite
NPRM	12/00/26

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Shena Arellano, Policy Analyst, Department of Health and Human Services, Food and Drug Administration, Office of the Commissione 10903 New Hampshire Avenue, Silver Spring, MD 20993

Phone: 301 796-8353

Email: shena.arellano@fda.hhs.gov ( printed page 52843)

RIN: 0910-AI50

HHS—FDA

47. SUBSTANCES GENERALLY RECOGNIZED AS SAFE

Priority: Economically Significant. Major status under 5 U.S.C. 801 is undetermined.

Regulatory Accounting: Regulatory

Unfunded Mandates: Undetermined

Legal Authority: 21 U.S.C. 321; 21 U.S.C. 342; 21 U.S.C. 348; 21 U.S.C. 371

Relevant Executive Orders: 14212; 13272; 13100

CFR Citation: 21 CFR part 170; 21 CFR part 570

Legal Deadline: None

Abstract: This rule, if finalized, would amend FDA's regulations at 21 CFR parts 170 and 570 to require the submission of a generally recognized as safe (GRAS) notice for the use of a human or animal food substance that is purported to be GRAS under the conditions of its intended use under section 201(s) of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The rule would clarify that FDA maintain and update the public-facing GRAS notice inventory for all substances that are the subject of mandatory GRAS notice for the conditions of their intended use. The rule would also clarify the process under which FDA would determine that the use of a substance is not GRAS. This change would provide greater transparency about substances that are added to food, so that FDA can more efficiently determine if the use of a substance constitutes a food additive use that is subject to the premarket review and approval requirements under the FD&C Act.

Statement of Need: This proposed rule would revise the procedures by which a person introducing a human or animal food substance into interstate commerce notifies FDA of a conclusion that the use of such substance is generally recognized as safe (GRAS). Specifically, the proposed rule would require the submission of GRAS notices to FDA for certain uses of food substances. A substance that is GRAS under the conditions of its intended use is not subject to FDA premarket review and approval as a food additive for that particular use (see sections 201(s) and 409 of the FD&C Act). Under our current regulations, a person who concludes that the use of a substance is GRAS under the conditions of its intended use may, but is not required to, notify FDA of this conclusion. The submission of a GRAS notice is therefore currently voluntary. If the proposed rule is finalized, GRAS notices will be required for certain uses of substances in human and animal food. Uses of food substances that are subject to the mandatory notification requirement will be presumed by FDA not to be GRAS unless the notification requirement has been met regarding the use of the substance.

Summary of Legal Basis: We are issuing this proposed rule consistent with our authority in sections 201, 402, 409, and 701 of the FD&C Act (21 U.S.C. 321, 342, 348, 371).

Alternatives: TBD

Anticipated Cost and Benefits: The primary benefits of the proposed rule, if finalized, would come from increased information being made available to FDA and the public regarding substances used in human and animal foods. This information would enable us to more effectively determine if the use of a substance constitutes a food additive use that is subject to premarket review and approval under the FD&C Act. This information is also expected to help FDA identify and prevent the use of unsafe food additives in food, thereby enabling FDA to regulate the safety of food substances more effectively. One-time costs of the proposed rule to persons who introduce a substance into interstate commerce under the GRAS provision of section 201(s) of the FD&C Act include reading the rule and revising standard operating procedures (SOPs) regarding GRAS notices. Other one-time per manufacturer costs of the proposed rule are preparing and submitting streamlined submissions related to uses of substances introduced into interstate commerce under the GRAS provision of section 201(s) of the FD&C Act before the effective date of a final rule, for firms that choose to submit this information during the window of availability for this time-limited option for such submissions. Costs associated with these activities may include translation costs for manufacturers in non-English speaking countries. Recurring costs to affected manufacturers would include preparing and submitting GRAS notices for the uses of substances introduced into interstate commerce under the GRAS provision of section 201(s) of the FD&C Act after the effective date of a final rule that would otherwise have been the subject of an independent conclusion of GRAS status ( i.e., a GRAS conclusion has been reached without submitting a GRAS notice).

Risks: TBD

Timetable:

Action	Date	FR Cite
NPRM	12/00/26

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: None

Agency Contact: Paulette Gaynor, Senior Policy Advisor, Department of Health and Human Services, Food and Drug Administration, Human Foods Program, 4300 River Road, Room 2053 (HFS-255), College Park, MD 20740-3835

Phone: 240 402-1192

Fax: 301 436-2965

Email: paulette.gaynor@fda.hhs.gov

RIN: 0910-AJ02

HHS—FDA

48. • TRANSPARENCY IN DIRECT-TO-CONSUMER ADVERTISING

Priority: Economically Significant. Major under 5 U.S.C. 801.

Regulatory Accounting: Regulatory

Unfunded Mandates: Undetermined

Legal Authority: The Federal Food, Drug, and Cosmetic Act, section 502(n) (21 U.S.C. 352)

Relevant Executive Orders: 14303; 14212; 13563

CFR Citation: 21 CFR 202

Legal Deadline: None

Abstract: This rule will revise 21 CFR 202.1 to eliminate the option for prescription drug advertisements broadcast through media such as radio or television to fulfill the statutory brief summary requirement in section 502(n) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) by disclosing risk, contraindication, and other safety information in another source beyond the advertisement itself.

Statement of Need: Until relatively recently, Direct-to-Consumer (DTC) broadcast advertisements for prescription drugs were rare, in part because drug companies had not been advised by FDA how they could meet the adequate provision requirement for dissemination of the FDA-approved labeling in connection with broadcast ads. In 1999, FDA issued a final guidance document, that described an approach to fulfill the adequate provision requirement for broadcast advertisements. The approach created a loophole that resulted in certain important information being hidden behind 1-800 numbers, print inserts, and websites, rather than being included in the broadcast advertisement.

The proliferation of DTC advertising across television and digital platforms has created potential patient confusion and harm from inappropriate demand for medications, distorting the doctor-patient relationship leading to misalignment of therapeutic choices ( printed page 52844) with actual patient needs, and the misallocation of healthcare resources and government overspending. FDA proposes revising the prescription drug advertising regulation to require DTC ads broadcast through media such as radio and television to disclose all relevant risk and safety information to consumers within the confines of the ad itself rather than referring consumers to an external source where they can request the full FDA-approved labeling. This action does not constitute a ban or unreasonable imposition on DTC drug advertising, but would instead require complete and accurate safety, contraindication, and other risk information in DTC prescription drug advertisements, so that patients and consumers can make fully informed decisions.

Summary of Legal Basis: FDA has authority to promulgate rules governing the promotion of prescription drugs under Section 502(n) of the FD&C Act [21 U.S.C. 352(n)], which states that promotional material shall include “such other information in brief summary relating to side effects, contraindications, and effectiveness as shall be required in regulations[.]” FDA has set forth regulations under 502(n) at 21 CFR 202.1, including the “adequate provision” language at issue here. Id. at 202.1(e)(1)(i)(B).

Alternatives: Removing the “adequate provision” loophole permitting the disclosure of “all necessary information related to side effects and contraindications” in a location other than the promotional material is the only option to effectuate the goals and direction of the September 9, 2025, Presidential Memorandum instructing HHS and FDA to “take appropriate action to ensure transparency and accuracy in direct-to-consumer prescription drug advertising, including by increasing the amount of information regarding any risks associated with the use of any such prescription drug required to be provided in prescription drug advertisements, to the extent permitted by applicable law.”

Anticipated Cost and Benefits: FDA anticipates that this rule, if finalized, will result in regulatory costs. Industry will face costs of either: (1) purchasing additional advertising time to include required product safety information, (2) dedicating additional advertising time within current advertising time slots toward the newly required information, or (3) the opportunity cost of choosing not to advertise if the cost of inclusion of all newly required safety information induces a decrease or cessation of product advertising. To provide context for the magnitude of such potential costs, we note that, in 2023, the top ten pharmaceutical companies spent a combined $13.8 billion on the promotion of drugs directed at U.S. consumers and physicians (source: CSRxP Analysis: Direct-To-Consumer Advertising Report. (2025). In CSRxP.org. The Campaign for Sustainable Rx Pricing. www.csrxp.org/wp-content/uploads/2025/04/CSRxP-Analysis-Direct-to-Consumer-Advertising-Report.pdf). Given the potential impact on advertising spending, we expect this rule to be economically significant, with annual costs exceeding $100 million for at least one year. The benefits of this rule are in providing patients more complete safety information during all advertisements covered by the rule, thus improving consumer understanding when they participate in healthcare decision making.

Risks: TBD

Timetable:

Action	Date	FR Cite
NPRM	12/00/26

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: Undetermined

Federalism: Undetermined

International Impacts: This regulatory action will be likely to have international trade and investment effects, or otherwise be of international interest.

Agency Contact: Lowell Zeta, Deputy Commissioner of Strategic Initiatives, Department of Health and Human Services, Food and Drug Administration, 10903 New Hampshire Avenue, WO Building 1, Room 2314, Silver Spring, MD 20993

Phone: 301 332-8931

Email: lowell.zeta@fda.hhs.gov

RIN: 0910-AJ14

HHS—FDA

49. • PROACTIVE DISCLOSURE OF COMPLETE RESPONSE LETTERS

Priority: Other Significant

Regulatory Accounting: Regulatory

Unfunded Mandates: Undetermined

Legal Authority: The Federal Food, Drug, and Cosmetic Act, section 505(1) (21 U.S.C. 355(1)); The Freedom of Information Act at 5 U.S.C. 552(a)

Relevant Executive Orders: 14212; 13563; 14303

CFR Citation: 21 CFR 20; 21 CFR 312.130; 21 CFR 314.430; 21 CFR 601.51; 21 CFR 814.9

Legal Deadline: None

Abstract: This rule will revise 21 CFR 312.130, 314.430, 601.51, and 814.9 to clarify and expand the discretion of the Commissioner of the Food and Drug Administration regarding the public release of Complete Response Letters (CRLs) and not approvable letters. This rule will eliminate the longstanding presumption that the mere existence of a marketing application constitutes confidential commercial information, thereby enabling proactive disclosure of CRLs for unapproved products while maintaining appropriate redactions for trade secrets and personal private information.

Statement of Need: CRLs and not approvable letters are summary documents FDA issues to sponsors when it completes its review cycle and determines that it cannot grant approval of an application in its current form. FDA describes in the letters the specific deficiencies identified during the review of safety and effectiveness data in the application which prevent it from granting approval of an application. CRLs and not approvable letters often contain confidential commercial information (CCI), trade secret information (TSI), (and personal private information (PPI)) that will be redacted prior to any public disclosure under the Trade Secrets Act and section 301(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

There are compelling public interests favoring the disclosure of CRL information and a good cause finding for this rule. Sponsors can leverage this valuable information to avoid common missteps and to provide enhanced predictability leading to more meaningful cures and treatments. Such efficiencies support the public interest in the availability, safety, and effectiveness of medical products and their efficient entry onto the market. Information related to the safety and effectiveness (and timeliness) of treatments is an issue of the utmost importance to patients and their families, and healthcare professionals evaluating and recommending care for patients. In addition, greater transparency will help to ensure sponsors provide complete and contextualized information in public announcements and to investors and shareholders. FDA recognizes the tremendous public interest in the transparency and credibility of FDA decision-making. Restoring common sense and gold standard science to America's public health system is an issue of paramount importance.

Summary of Legal Basis: FDA's authority to release CRL information is ( printed page 52845) derived from the Federal Freedom of Information Act (FOIA) at 5 U.S.C. 552(a), section 505(l) of the FD&C Act) at 21 U.S.C. 355(l), and FDA information disclosure regulations at 21 CFR part 20 and 21 CFR parts 312.130, 314.430, and 601.51. Federal law and FDA regulations provide FDA significant discretion to disclose CRL information including certain safety and effectiveness deficiencies associated with a pending application, regardless of whether the application has been made public. See 21 U.S.C. 355(l)(1). As set forth in 21 CFR 314.430(a)-(c), FDA's statements and deliberations reflected in CRLs are not property of the sponsor and can be disclosed by FDA.

Alternatives: There is no alternative method of changing the current regulatory structure to permit the disclosure of CRLs associated with applications whose existence has not been made public. Amending 21 CFR parts 312.130, 314.430, 601.51, and 814.9 enables FDA to clarify and revise its longstanding presumption that the mere existence of an application is CCI and thus cannot be disclosed to the public, permitting the disclosure of CRLs related to otherwise non-public applications.

Anticipated Cost and Benefits: The benefits of the proposed rule would be increased transparency into FDA decision-making on CRLs, which may help future sponsors avoid submitting applications with the deficiencies explained in the CRLs. The costs of the proposed rule include costs to read and understand both the rule and the CRLs to interested parties, as well as costs to redact and publish CRLs on FDA's website.

Risks: TBD

Timetable:

Action	Date	FR Cite
NPRM	10/00/26

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Federalism: Undetermined

International Impacts: This regulatory action will be likely to have international trade and investment effects, or otherwise be of international interest.

Phone: 301 332-8931

Email: lowell.zeta@fda.hhs.gov

RIN: 0910-AJ16

HHS—FDA

50. • ELECTRONIC LABELING FOR MEDICAL DEVICES

Priority: Economically Significant. Major status under 5 U.S.C. 801 is undetermined.

Regulatory Accounting: Deregulatory

Unfunded Mandates: Undetermined

Legal Authority: 21 U.S.C. 352(f)

Relevant Executive Orders: 14303; 14212; 13951; 14273

CFR Citation: Not Yet Determined

Legal Deadline: None

Abstract: This rule would clarify that the adequate directions for use requirement in section 502(f) of the Federal Food, Drug, and Cosmetic Act could be satisfied when labeling is provided solely by electronic means for certain types of devices in certain circumstances. FDA anticipates that this clarification would facilitate the communication of comprehensive and up-to-date information to users to provide reasonable assurance of the safety and effectiveness of such medical devices.

Statement of Need: The proposed rule, if finalized, would clarify that the “adequate directions for use” requirement under section 502(f) of the Federal Food, Drug, and Cosmetic Act could be satisfied when labeling is provided solely by electronic means for certain types of prescription and non-prescription devices used outside of health care settings, and would establish the associated requirements for use of such electronic labeling. Considering the current widespread use of and access to the internet, particularly through mobile devices, this rulemaking would help modernize the way required labeling is provided to consumers of medical devices. This clarification would help manufacturers facilitate the communication of robust and up-to-date labeling necessary to provide reasonable assurance of the safety and effectiveness of medical devices. Electronic labeling for medical devices would also reduce various administrative and resource burdens associated with printing, and subsequent revision and redistribution, of print labeling, and would better help manufacturers quickly and efficiently update any labeling. Electronic forms of required labeling can also increase access to labeling in various ways, such as by enabling users to access labeling online at any time and place, and by increasing accessibility for users with visual impairments. The proposed rule, if finalized, would require that access to electronic labeling be readily available and unrestricted, while also requiring that manufacturers afford users the opportunity to request and then promptly provide labeling in paper form.

Summary of Legal Basis: The legal basis for this action is 502(f) of the FD&C Act. 502(f) of the FD&C Act, a device shall be deemed misbranded unless its labeling bears adequate directions for use and such adequate warnings (to the extent applicable) in such manner and form as are necessary for the protection of users. The term labeling contemplates both physical and non-physical forms, as it is defined as “all labels and other written, printed, or graphic matter (1) upon any article or any of its containers or wrappers, or (2) accompanying such article.” 21 U.S.C. 321(m). The term accompanying has been interpreted liberally to extend beyond physical association with the product, and includes materials provided electronically. The statutory language does not require labeling to be provided solely in paper form for all devices and in fact contemplates different manner[s] and form[s] of permissible labeling to protect the public health. A clarification via rulemaking that certain information can be provided electronically would not alter the existing requirements for adequate directions for use, but instead would clarify that such required labeling may be provided in either physical or electronic form for certain devices in certain circumstances.

Alternatives: FDA has considered taking action via guidance. However, the focus of this effort is to clarify the availability of electronic labeling for certain types of prescription and non-prescription devices used outside of health care settings and establish the requirements for such use of electronic labeling. In order to make these requirements binding they would need to be captured in regulations, as guidance would not allow FDA to accomplish this level of specificity in a binding manner.

Anticipated Cost and Benefits: FDA anticipates that this rule is deregulatory. The rule, if finalized, would produce cost-savings for firms, as it would reduce the various administrative and resource burdens of printing and distributing paper labeling for specific medical devices. Additionally, electronic labels can be updated as needed without costly updates to a physical label. We note that firms can still choose to use physical labeling if they find it more cost effective. The cost of this rule comes in the form of time cost for consumers who are unable to ( printed page 52846) access electronic labeling and must request labeling in paper form or those who prefer to request labeling in paper form rather than access labeling electronically. Benefits of this rule include increased accessible labeling as consumers can adjust font size, use text to voice, and access other accessibility features in electronic labeling. Additionally, the availability of electronic labeling will facilitate the communication of comprehensive and up to date information to consumers. We anticipate that this regulation will be net cost savings and therefore deregulatory.

Risks: TBD

Timetable:

Action	Date	FR Cite
NPRM	11/00/26

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: None

Agency Contact: Rachel Park, Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, 10903 New Hampshire Ave., WO Bldg. 66, Silver Spring, MD 20993

Phone: 301 796-7944

Email: rachel.park@fda.hhs.gov

RIN: 0910-AJ17

HHS—FDA

51. • NUTRIENT CONTENT CLAIMS FOR ADDED SUGARS

Priority: Other Significant. Major status under 5 U.S.C. 801 is undetermined.

Regulatory Accounting: Regulatory

Unfunded Mandates: Undetermined

Legal Authority: Not Yet Determined

Relevant Executive Orders: 14212; 14303

CFR Citation: Not Yet Determined

Legal Deadline: None

Abstract: The rule would update definitions, terminology, and provisions related to nutrient content claims and added sugars to be consistent with terms related to and updates to requirements for the Nutrition Facts label. The rule would, among other things, define a new “low added sugar” nutrient content claim that manufactures could voluntarily use to communicate information about the level of added sugars in food products.

Statement of Need: In 2016, FDA updated the requirements for the Nutrition Facts label and serving size information for packaged foods to reflect new scientific information, including the link between diet and chronic diseases such as obesity and heart disease. Among the updates to the Nutrition Facts label was the requirement that added sugars be included in the Nutrition Facts label and the establishment of a daily value (DV) for added sugars. The declaration for added sugars was established, in part, because excess consumption of added sugars makes it difficult to meet nutrient needs within the calorie limits generally needed to maintain a healthy weight and can lead to an increase in overall caloric intake. Further, healthy dietary patterns that are characterized by lower amounts of sugar-sweetened foods and beverages, as compared to less healthy dietary patterns, are associated with a reduced risk of cardiovascular disease. This proposed rule, if finalized, would update definitions, terminology, and provisions related to nutrient content claims and added sugars to be consistent with the terms related to and the previous updates to the requirements for the Nutrition Facts label.

Summary of Legal Basis: We are issuing this proposed rule consistent with our authority in sections 201, 301, 403, and 701 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 331, 343, and 371).

Alternatives: None.

Anticipated Cost and Benefits: The proposed rule will include several provisions. For one, it will propose to update the definition of added sugars in the existing no added sugar, without added sugar, or no sugar added claims to be consistent with the declaration on the updated Nutrition Facts label. This proposal, if finalized, would cause manufacturers who are voluntarily using the older no added sugar claims and whose products are not consistent with definition of added sugars to either reformulate products or to remove claims from the label, both of which involve costs to the manufacturer. In addition, the proposed rule will propose to define a claim of “low added sugars” and allow factual quantitative amount statements for added sugars on the labels of certain products. These proposals, if finalized, would provide claims that have not previously been available for use by manufacturers. If manufacturers voluntarily choose to use these new claims on their labels, there would be relabeling costs involved. Finally, the proposed rule will propose to update the terminology in existing nutrient content claims for added sugars and total sugars that are not consistent with the terms used in the updated Nutrition Fact label regarding the Added Sugars and Total Sugars declarations. This proposal, if finalized, would require manufacturers who are using the older added sugar or total sugar claims to relabel and incur relabeling costs to correct terminology ( i.e., change the term “sugar” to “sugars”) or to remove the claim.

Risks: TBD

Timetable:

Action	Date	FR Cite
NPRM	12/00/26

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Federalism: Undetermined

Agency Contact: Vincent De Jesus, Nutritionist, Department of Health and Human Services, Food and Drug Administration, Human Foods Program, Office of Nutrition and Food Labeling, 5001 Campus Dr., College Park, MD 20740

Phone: 240 402-2371

Fax: 301 436-1191

Email: vincent.dejesus@fda.hhs.gov

RIN: 0910-AJ20

HHS—FDA

52. • MODIFICATION OF CERTAIN TERMINOLOGY IN TITLE 21

Priority: Other Significant

Regulatory Accounting: Other

Legal Authority: 21 U.S.C. 321 to 397; 42 U.S.C. 201; 42 U.S.C. 216; 42 U.S.C. 241 to 242(a); 42 U.S.C. 262; 42 U.S.C. 263a and b; 42 U.S.C. 264; 15 U.S.C. 1451 to 1461; 28 U.S.C. 2112; 5 U.S.C. 551 to 558; 5 U.S.C. 701 to 706; 21 U.S.C. 141 to 149; 21 U.S.C. 467f; 21 U.S.C. 679; 21 U.S.C. 821; 21 U.S.C. 1034; Pub. L. 117-103, 136 Stat. 49

Relevant Executive Orders: 14168; 14303; 13563

CFR Citation: 21 CFR 10.65; 21 CFR 56.107; 21 CFR 106.121; 21 CFR 201.57; 21 CFR 600.80; 21 CFR 803.42

Legal Deadline: None

Abstract: The Food and Drug Administration is issuing a rule to modify certain terminology in Title 21 of the Code of Federal Regulations to comply with Executive Order 14168, Defending Women From Gender Ideology Extremism and Restoring Biological Truth to the Federal Government, issued on January 20, 2025. Specifically, this rule, if finalized, will remove the term gender wherever it appears and either replace it with the term sex, or delete reference to gender as applicable, along with other editorial changes to improve readability.

Statement of Need: The terms gender and sex appear in various contexts in ( printed page 52847) FDA regulations, including in requirements related to Institutional Review Board (IRB) membership (see 21 CFR 56.107), records and reporting requirements for product applications and approvals (see, e.g.,21 CFR 312.42, 314.50, 314.80, 600.80, 803.32), and device classification regulations (see, e.g.,21 CFR 862.1840, 866.3215, 866.5950). Section 2(a) of E.O. 14168 defines sex as referring to “an individual's immutable biological classification as either male or female. `Sex' is not a synonym for and does not include the concept of `gender identity.' Section 3(c) of E.O. 14168 requires, among other things, that [w]hen administering or enforcing sex-based distinctions, every agency and all Federal employees acting in an official capacity on behalf of their agency shall use the term sex and not gender in all applicable Federal policies and documents. Accordingly, FDA is modifying regulations to remove the term gender wherever it appears, to either replace it with the term sex, or delete reference to gender as applicable.

Summary of Legal Basis: FDA proposes to issue this rule under the following authorities: The Federal Food, Drug, and Cosmetic Act (FD&C Act) (at 21 U.S.C. 321 et seq.) and specifically, sections 321-397; the Public Health Service (PHS) Act at 42 U.S.C. 201, 216, 241, 242(a), 262, 263a, 263b, 264; and 15 U.S.C. 1451-1461; 5 U.S.C. 551-558, 701-706; 21 U.S.C. 141-149, 467f, 679, 821, 1034; 28 U.S.C. 2112; and section 111 of Pub. L. 117-103 (Consolidated Appropriations Act, 2022), 136 Stat. 49 at 789. FDA also has general authority to issue regulations for the efficient enforcement of the FD&C Act and the PHS Act under section 701 of the FD&C Act (21 U.S.C. 371) and section 351(j) of the PHS Act.

Alternatives: Alternative option: leave current regulations unchanged and update terminology when each regulation is amended for programmatic or other reasons. The drawback of this approach is that the sex/gender terminology in Title 21 would remain inconsistent until every provision is revised individually. In addition, taking this approach would not be in compliance with the directives of E.O. 14168.

Anticipated Cost and Benefits: This proposed rule reflects editorial changes that affect FDA and does not impact industry practices. Consequently, we do not anticipate any measurable change in industry resulting from this proposed rule. We also expect the economic impact on the FDA to be minimal. This proposed rule will produce no quantifiable savings, costs, or transfers. We do not expect any loss of public health benefits as a result of this rule.

Risks: TBD

Timetable:

Action	Date	FR Cite
NPRM	07/00/26
NPRM Comment Period End	09/00/26

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Swati Kabaria, Senior Policy Advisor, Department of Health and Human Services, Food and Drug Administration, 10903 New Hampshire Ave., WO Bldg. 32, Rm. 4262, Silver Spring, MD 20993

Phone: 301 796-8569

Email: swati.kabaria@fda.hhs.gov

RIN: 0910-AJ26

HHS—FDA

53. • AMENDMENTS TO 21 CFR PARTS 56 AND 312; EXPEDITED INVESTIGATIONAL NEW DRUG APPLICATION FOR PHASE 1 CLINICAL TRIAL REFORM

Priority: Economically Significant. Major under 5 U.S.C. 801.

Regulatory Accounting: Deregulatory

Unfunded Mandates: Undetermined

Legal Authority: 21 U.S.C. 321; 21 U.S.C. 331; 21 U.S.C. 351; 21 U.S.C. 352; 21 U.S.C. 353; 21 U.S.C. 355; 21 U.S.C. 360bbb; 21 U.S.C. 371; 42 U.S.C. 262

Relevant Executive Orders: 14212; 14273; 14293

CFR Citation: 21 CFR 56; 21 CFR 312 Subparts A, B, C, D

Legal Deadline: None

Abstract: The Food and Drug Administration is proposing to amend 21 CFR 312 Subparts A, B, C, D and 21 CFR 56, for expedited Investigational New Drug (IND) reform. The proposed rule would make changes to general provisions related to the IND requirements, including process and IND content and format and sponsor responsibilities.

Statement of Need: FDA is proposing this action to modernize and streamline the Investigational New Drug (IND) application process for Phase 1 clinical trials by reducing unnecessary regulatory burden through targeted, risk-based flexibilities. The action is needed to accelerate patient access to promising investigational therapies while maintaining appropriate human subject protections. By facilitating earlier clinical development of innovative drugs, this rule is expected to reduce delays that can adversely affect patient health outcomes and to address regulatory risks that are disproportionate to the low-risk nature of many early-phase studies. This type of reform is also a do out of the MAHA Commission as part of the White House's Make Our Children Healthy Again: Strategy Report (September 2025) and aligned with the Administration's deregulatory efforts.

Summary of Legal Basis: FDA's authority lies under the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act, including 21 U.S.C. 321, 331, 351 to 355, 360bbb, and 371, and 42 U.S.C. 262, to revise IND and IRB requirements for Phase 1 clinical trials. The proposed rule is intended to support risk-based regulatory modernization consistent with recent Executive Orders on deregulatory reform and innovation in healthcare.

Alternatives: FDA considered maintaining the current IND framework without modification, as well as implementing narrower administrative guidance instead of formal rulemaking. The Agency also considered more limited exemptions applicable only to specific therapeutic categories but determined broader risk-based flexibilities would better reduce unnecessary burden while preserving appropriate human subject protections, especially given Administration interest in these reforms.

Anticipated Cost and Benefits: FDA is proposing to amend 21 CFR 312 Subparts A, B, C, D and 21 CFR 56, for expedited Investigational New Drug (IND) reform. The proposed rule would make changes to general provisions related to the IND requirements, including process, content, format and sponsor responsibilities. FDA anticipates benefits from this rule emanating from loosening requirements. This streamlining for the use of certain investigational drugs for Phase I clinical trials through targeted and risk-based exemptions to speed the access of investigational drugs to patients would decrease regulatory burden, which may help accelerate access to transformative treatments for patients, which may lead to improved health outcomes. We anticipate costs of this rule would include reading and understanding what new flexibilities would be afforded to sponsors and any potential safety risks of loosening current requirements.

Risks: Potential risks include inconsistent sponsor interpretation of new flexibilities, and the possibility that streamlined requirements could increase safety concerns or data quality issues in low-risk studies while firms adjust. FDA expects these risks to be mitigated through existing Institutional ( printed page 52848) Review Board review, sponsor responsibilities, and continued FDA monitoring authority, as well as sponsor education and early engagement.

Timetable:

Action	Date	FR Cite
NPRM	07/00/26

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Federalism: Undetermined

Phone: 301 332-8931

Email: lowell.zeta@fda.hhs.gov

RIN: 0910-AJ30

HHS—Health Resources and Services Administration (HRSA)	Proposed Rule Stage

54. • STRENGTHENING REGULATORY OVERSIGHT OF THE ORGAN PROCUREMENT AND TRANSPLANTATION NETWORK TO ENSURE PATIENT SAFETY

Priority: Other Significant

Regulatory Accounting: Regulatory

Legal Authority: 42 U.S.C. 216, 274; 42 U.S.C. 1320b-8; 42 CFR 121.4(2)

Relevant Executive Orders: 14292; 14212; 14303

CFR Citation: 42 CFR part 121

Legal Deadline: NPRM, Statutory, December 19, 2025.

Abstract: The Health Resources and Services Administration (HRSA) seeks to use the authority described in 42 CFR 121.4(b)(2) to make policies of the Organ Procurement and Transplantation Network (OPTN) enforceable by formally approving them through the federal rulemaking process. Currently, compliance with OPTN policies is voluntary unless the Secretary has formally approved the policies. HRSA is also proposing rulemaking action to: (1) update regulatory language to align it with provisions of the Securing the U.S. Organ Procurement and Transplantation Act, Public Law 118-14 (Sept. 22, 2023) and (2) remove a paragraph of part 121 that references a prior effective date of the regulations.

Statement of Need: HRSA is pursuing rulemaking to address widespread non-compliance with OPTN policies, resulting in harm to patients and families. HRSA-led investigations, external investigative reporting, and Congressional hearings have revealed problems with the organ procurement and transplant system stemming from the failure of Organ Procurement Centers and transplant centers to adhere to OPTN policy. HRSA is also pursuing rulemaking to align existing regulations with the 2023 Securing the U.S. Organ Procurement and Transplantation Act.

Summary of Legal Basis: The implementing regulations of the National Organ Transplant Act (NOTA) (the OPTN final rule, 42 CFR part 121), describe a process by which certain policies of the OPTN may be made enforceable by HHS by promulgating those policies through federal rulemaking (42 CFR 121.4(b)(2)). Additionally, Section 1138 of the Social Security Act (42 U.S.C. 1320b-8) (section 1138) requires Medicare and Medicaid participating hospitals that perform transplants to be members of the OPTN and to abide by its rules and requirements.¹ Since violations of section 1138 could result in the withholding of a transplant hospital's reimbursement under Medicare or Medicaid, or termination from these programs, HHS has stated that for an OPTN policy to be considered a rule or requirement of the OPTN, and therefore mandatory or binding on OPOs and hospitals participating in Medicare or Medicaid, the Secretary must have given formal approval to the rule or requirement. Therefore, the term rules and requirements of the OPTN means those rules and requirements formally approved by the Secretary through the rulemaking process.² Once certain OPTN policies are enforceable by the Secretary, CMS and HRSA, as per the authority delegated by the Secretary, may take enforcement actions based on violations of these OPTN policies.

HRSA also seeks to make technical edits to 42 CFR 121.3(c)(1), to align the OPTN final rule with provisions of the Securing the U.S. Organ Procurement and Transplantation Act (Securing Act), Public Law 118-14 (Sept. 22, 2023) and to delete 42 CFR 121.3(d), which refers to a date in the past (June 30, 2000) by which requirements of 42 CFR 121.3 needed to be met.

[1] See 54 FR 51802 (December 18, 1989) ( Federal Register notice setting forth Secretary's interpretation of section 1138 provisions.)

[2] See 63 FR 16297 (April 2, 1998).

Alternatives: TBD

Anticipated Cost and Benefits: We anticipate benefits related to reduced health and safety risks for patients, and improvements in the equitable allocation of organs, patient safety, and transparency. We anticipate costs associated with greater adherence to documentation requirements, provider responsibilities, screening criteria, and increased reporting on patient safety events.

Risks: TBD

Timetable:

Action	Date	FR Cite
NPRM	09/00/26
NPRM Comment Period End	11/00/26

Regulatory Flexibility Analysis Required: No

Government Levels Affected: Federal

Agency Contact: Raymond Lynch, Chief, Organ Transplantation Branch, Department of Health and Human Services, Health Resources and Services Administration, 5600 Fishers Lane, Rockville, MD 20857

Phone: 301 443-3300

RIN: 0906-AB34

HHS—Office of Assistant Secretary for Health (OASH)	Proposed Rule Stage

55. • HUMAN RESEARCH PROTECTIONS: EXEMPTIONS AND CLARIFYING PROVISIONS RELATED TO INSTITUTIONAL REVIEW BOARD OVERSIGHT

Priority: Other Significant. Major status under 5 U.S.C. 801 is undetermined.

Regulatory Accounting: Deregulatory

Legal Authority: 5 U.S.C. 301; 42 U.S.C. 289(a); 42 U.S.C. 300v-1(b)

Relevant Executive Orders: 14179; 13563; 14303

CFR Citation: 45 CFR part 46

Legal Deadline: None

Abstract: The Department is proposing revisions to 45 CFR part 46 to modernize and simplify subpart A, known as the Common Rule. Changes are intended to uphold protections for human subjects while reducing burden and ambiguity for investigators, institutional review boards, and research institutions. Examples of changes include clarifying terminology, expanding exemptions for certain low-risk research activities, and enabling flexibilities for regulatory review of de minimis protocol changes. The Department will collaborate with the other Common Rule Departments and Agencies during this process.

Statement of Need: The foundational framework for human subjects protection in the United States was established by the National Research Act of 1974 in response to widespread public concern over unethical biomedical and behavioral research practices. Following its passage, the ( printed page 52849) then-Department of Health, Education, and Welfare issued the first version of 45 CFR part 46. These regulations established institutional review boards (IRBs) as the key mechanism for oversight and ethical review of human subjects research. While these protections remain vital, the current regulatory framework no longer reflects the realities of modern research.

In 1991 the Federal Policy for the Protection of Human Subjects, known as the Common Rule, was formally adopted by HHS and 15 other federal departments and agencies. Although the last major revision in 2017 introduced several changes to modernize human subject protections while reducing unnecessary regulatory burden, investigators and institutions have continued to report that the Common Rule imposes unnecessary burdens and unclear requirements, particularly for minimal-risk studies. For example, the Department has received feedback that applying the Common Rule remains cumbersome for research within Learning Healthcare Systems and for other research methods that are integrated into clinical care settings and are intended to improve the quality and safety of medical care.

Without additional changes intended to clarify ambiguities, expand flexibilities, and redirect protective measures toward high-risk activities, the rights and safety of research participants as well as scientific breakthroughs can be impeded. Examples of how this rulemaking will address these issues include expanding exemptions for certain additional types of low-risk research, incorporating flexibilities for de minimis protocol changes, and clarifying key terms such as the definition of undue influence. These reforms will reduce ambiguity and undue administrative burden for institutions engaged in HHS-supported and conducted human research and will enable IRBs and human research protection programs to focus on those activities posing the greatest risk to human participants while reducing barriers to research that could benefit society.

Summary of Legal Basis: U.S. Code Title 42, Section 289 requires the Secretary of Health and Human Services (HHS) to establish regulatory requirements for human research protections, a program for guidance, and a process for responding to violations. The President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research was described in 42 U.S.C. 300v, and the reports and recommendations that were created by this commission were integral to the development and promulgation of the Common Rule.

Alternatives: The Department considered maintaining the current Common Rule framework without modification, as well as relying solely on subregulatory guidance or interpretive materials to clarify existing requirements. HHS determined that broader regulatory updates are necessary to improve consistency, reduce administrative burden, and ensure that oversight remains appropriately calibrated to the level of risk posed to research participants.

Anticipated Cost and Benefits: The Department expects that the overall economic and social impact of this proposed rule will be deregulatory in nature and designed to improve efficiency, consistency, and proportionality of the rule's application. New costs attributable to this proposed rule would be associated with regulated entities' obligations to comply with updated requirements.

The Department anticipates that this proposed rule would generate significant quantifiable and unquantifiable deregulatory benefits by improving efficiency and enabling a more risk-based application of human subjects protections requirements. By expanding flexibilities for low-risk research activities and clarifying existing requirements, the proposed rule is expected to reduce administrative burden on investigators, institutions, and institutional review boards while helping accelerate scientific discovery, improve healthcare delivery practices, and support more timely development of treatments and interventions that benefit public health.

Risks: Potential risks include concerns from some stakeholders that expanded exemptions and additional regulatory flexibilities could reduce oversight for certain categories of research or create inconsistent implementation across institutions. The Department expects these risks to be mitigated through continued IRB oversight for higher-risk activities, existing human subject protections requirements, interagency coordination among Common Rule departments and agencies, and public engagement through the notice-and-comment process to ensure that participant protections remain strong while unnecessary burden is reduced.

Timetable:

Action	Date	FR Cite
NPRM	07/00/26

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses, Governmental Jurisdictions

Government Levels Affected: None

Agency Contact: Natalie Klein, Acting Director, Department of Health and Human Services, Office of Assistant Secretary for Health, Office for Human Research Protections, 1101 Wootton Parkway, Suite 200, Rockville, MD 20852

Phone: 240 453-6900

Email: ohrp@hhs.gov

RIN: 0937-AA16

HHS—Centers for Medicare & Medicaid Services (CMS)	Proposed Rule Stage

56. INTEROPERABILITY STANDARDS AND PRIOR AUTHORIZATION FOR DRUGS (CMS-0062)

Priority: Economically Significant. Major under 5 U.S.C. 801.

Regulatory Accounting: Other

Legal Authority: 42 U.S.C. 1395hh; 42 U.S.C. 1302; Pub. L. 104-191; Pub. L. 111-148, sec. 1104

CFR Citation: 42 CFR 422; 42 CFR 431; 42 CFR 438; 42 CFR 457; 45 CFR 156; . . .

Legal Deadline: None

Abstract: This rule would propose new requirements for Medicare Advantage (MA) organizations, state Medicaid fee-for service (FFS) programs, state Children's Health Insurance Program (CHIP) FFS programs, Medicaid managed care plans, CHIP managed care entities, and Qualified Health Plans (QHPs) offered on the Federally-facilitated Exchanges (FFEs) to streamline processes for the prior authorization for certain drugs. We are developing this rule, in part, based on the significant number of public commenters who responded to the CMS Interoperability and Prior Authorization proposed rule (87 FR 76238) urging CMS to expand the proposed prior authorization policies to include drugs. This rule would also propose a modified standard for prior authorization-related transactions under the Administrative Simplification provisions of HIPAA. In addition, as part of this rule, ASTP/ONC would propose to adopt updated versions of certain standards referenced in the proposed updated technical requirements for payer APIs, including standards supporting electronic prior authorization transactions. Finally, we are proposing to update the definition of “failure to report” under the Open Payments program.

Statement of Need: This proposed rule furthers CMS efforts to reduce ( printed page 52850) administrative burden on providers and allow them to spend more time on patient care. The proposals increase appropriate electronic access to health care data, while keeping that information safe and secure by utilizing the latest standards adopted by the Assistant Secretary for Technology Policy/Office of the National Coordinator for Health Information Technology. The proposals build on the CMS Interoperability and Prior Authorization final rule by expanding the types of prior authorizations that could be conducted electronically to include those for drugs. Based on public comments received on the CMS Interoperability and Prior Authorization proposed rule (87 FR 76238), we expect patients and providers will overwhelmingly support the addition of drugs to our prior authorization policies and the increased alignment across Medicare, Medicaid, CHIP and Marketplace coverage.

Summary of Legal Basis: The policies in this proposed rule are intended, where possible, to address disparities in standards and processes for prior authorization for drugs across Medicare Advantage, Medicaid, CHIP and QHPs offered on the FFEs. The statutory authority for these proposals is contained in the Social Security Act (42 U.S.C. 1302 and 1395hh).

Alternatives: In this proposed rule, we continue to build on the efforts from the CMS Interoperability and Patient Access final rule (85 FR 25510) and the CMS Interoperability and Prior Authorization final rule (89 FR 8758) to advance interoperability, improve care coordination, empower patients with access to their data, and improve prior authorization processes. When we excluded prior authorizations for drugs from the CMS Interoperability and Prior Authorization proposed rule, we received significant public feedback that we should reconsider that decision with future rulemaking. Those comments and engagements with industry experts over the past two years support our conclusions that the alternative of continuing to exclude drugs would leave significant burden on patients and providers.

Anticipated Cost and Benefits: We expect this rule will not be significant under section 3(f)(1). This rule proposes updates to the Application Programming Interfaces (APIs) already required by previous rules, proposes to require standards that were previously recommended, and proposes standards for the electronic prior authorization of drugs that are already required or being implemented across the country. We acknowledge that business processes would need to be updated for these payers, but we do not believe these costs would exceed the section 3(f)(1) threshold.

Risks: These policies are natural continuations of the policies finalized in the CMS Interoperability and Prior Authorization final rule. Adding certain drugs to the prior authorization requirements and data availability would close a gap in our current requirements.

Timetable:

Action	Date	FR Cite
NPRM	07/00/26

Regulatory Flexibility Analysis Required: No

Government Levels Affected: Federal, State

Agency Contact: David Koppel, Interoperability Policy Advisor, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Office of Healthcare Experience and Interoperability, 7500 Security Blvd., Baltimore, MD 21244

Phone: 303 844-2883

Email: david.koppel@cms.hhs.gov

RIN: 0938-AV44

HHS—CMS

57. STRENGTHENING THE INTEGRITY OF MEDICAID AND CHIP MANAGED CARE, FINANCING, AND ACCESS TO CARE (CMS-2450)

Priority: Economically Significant. Major under 5 U.S.C. 801.

Regulatory Accounting: Regulatory

Legal Authority: 42 U.S.C. 1302; 42 U.S.C. 1396u; 42 U.S.C. 1396r-8; Pub. L. 111-148; Pub. L. 119-21

CFR Citation: 42 CFR 431; 42 CFR 433; 42 CFR 438; 42 CFR 441; . . .

Legal Deadline: None

Abstract: This proposed rule would update regulations to strengthen the integrity of state enrollment processes, state directed payments and other payment and access requirements.

Statement of Need: Following an extensive review of rulemaking finalized in 2024, which includes the Medicaid and Children's Health Insurance Program Managed Care Access, Finance and Quality Final Rule (89 FR 41002; CMS-2439-F) and the Ensuring Access to Medicaid Services Final Rule (89 FR 40542; CMS-2442-F), CMS is developing a proposed rule to address priority fiscal and program integrity issues in Medicaid and the Children's Health Insurance Program (CHIP), including rescinding or revising provisions finalized in the 2024 final rules.

Additionally, CMS intends to propose a number of provisions to enhance oversight of states managed care plans, and provider enrollment, such as (1) revising various overpayment, disallowance, and other administrative action authorities, (2) adding new grounds for state Medicaid agencies (SMA) to use to terminate/deny the enrollment of bad actor providers, and (3) giving SMAs greater authority to conduct on-site visits of providers to verify compliance with state Medicaid requirements.

CMS would issue proposals affecting managed care and access that are intended to reduce administrative costs and regulatory and administrative burden for both state Medicaid and CHIP agencies and the federal government. CMS would also issue proposals that affect program integrity that are intended to decrease fraud and improper payments. These proposals, if finalized, would be expected to lessen burden on states and enable more efficient and cost-effective implementation of the revised provisions.

Summary of Legal Basis: To provide states with the direction they need on whether or how to implement the rulemaking finalized in 2024, and to give states notice as early as possible of CMS's plans for implementing sections 71103 and 71104 certain provisions of the One Big Beautiful Bill Act (OBBBA) (Public Law 119-21).

Alternatives: In developing the proposals for this rule, alternatives will be considered, including maintaining existing requirements. These alternatives will be described in the rule.

Anticipated Cost and Benefits: As we move toward publication, estimates of costs and benefits will be included in the rule.

Risks: Risks associated with the impact of this rule are under development and will be included in the published rule.

Timetable:

Action	Date	FR Cite
NPRM	07/00/26

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Federal, State

Federalism: Undetermined

Agency Contact: Kathryn Schultz, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Center for Medicaid and CHIP Services, ( printed page 52851) 7500 Security Blvd., Baltimore, MD 21244

Phone: 443 539-6172

Email: kathryn.schultz@cms.hhs.gov

RIN: 0938-AV70

HHS—CMS

58. • CY 2027 REVISIONS TO PAYMENT POLICIES UNDER THE PHYSICIAN FEE SCHEDULE AND OTHER REVISIONS TO MEDICARE PART B (CMS-1848) (SECTION 610 REVIEW)

Priority: Economically Significant. Major under 5 U.S.C. 801.

Regulatory Accounting: Other

Unfunded Mandates: Undetermined

Legal Authority: 42 U.S.C. 1302; 42 U.S.C. 1395hh

CFR Citation: 42 CFR 409; 42 CFR 410; 42 CFR 414

Legal Deadline: Final, Statutory, January 1, 2027, By statute, rule must be effective by January 1 annually.

Abstract: This annual proposed rule would revise payment polices under the Medicare physician fee schedule, and make other policy changes to payment under Medicare Part B, including for telehealth and primary care, to promote rural health and support deregulation. These changes would apply to services furnished beginning January 1, 2027. Additionally, this rule proposes updates to the Quality Payment Program.

Statement of Need: The statute requires that we establish each year, by regulation, payment amounts for all physicians' services furnished in all fee schedule areas. This rule would implement changes affecting Medicare Part B payment to physicians and other Part B suppliers and updates to the Quality Payment Program. The final rule has a statutory publication date of November 1, 2026, and an implementation date of January 1, 2027.

Summary of Legal Basis: Section 1848 of the Social Security Act (the Act) establishes the payment for physician services provided under Medicare. Section 1848 of the Act imposes an annual deadline of no later than November 1 for publication of the final rule or final physician fee schedule.

Alternatives: None. This rule implements a statutory requirement.

Anticipated Cost and Benefits: Total expenditures will be adjusted for CY 2027.

Risks: If this regulation is not published timely, physician services will not be paid appropriately, beginning January 1, 2027.

Timetable:

Action	Date	FR Cite
NPRM	07/00/26

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: Undetermined

Federalism: Undetermined

Agency Contact: Lindsey Baldwin, Director, Division of Practitioner Services, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Center for Medicare, 7500 Security Boulevard, Baltimore, MD 21244

Phone: 410 786-1694

Email: lindsey.baldwin@cms.hhs.gov

RIN: 0938-AV82

HHS—CMS

59. • COMPREHENSIVE REGULATIONS TO UNCOVER SUSPICIOUS HEALTHCARE (CRUSH) (CMS-6098)

Priority: Other Significant

Regulatory Accounting: Other

Legal Authority: 42 U.S.C. 1395hh

CFR Citation: Not Yet Determined

Legal Deadline: None

Abstract: This proposed rule would include provisions related to provider enrollment, medical review, investigations, and other program integrity oversight provisions that would greatly strengthen CMS's ability to crush fraud, enhance program integrity efforts across Medicare, Medicaid, and the Children's Health Insurance Program (CHIP), and maximize legislative authorities to address inappropriate payments.

Timetable:

Action	Date	FR Cite
Request for Information	02/27/26	91 FR 9803
RFI Comment Period End	03/30/26
NPRM	10/00/26

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Federal

Agency Contact: Kathleen O'Malley, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Center for Program Integrity, 7500 Security Boulevard, Baltimore, MD 21244

Phone: 410 786-8987

Email: kathleen.omalley@cms.hhs.gov

RIN: 0938-AV97

HHS—CMS	Final Rule Stage

60. STRENGTHENING OVERSIGHT OF ACCREDITING ORGANIZATIONS (AO), BURDEN REDUCTION, AND RELATED PROVISIONS (CMS-3367)

Priority: Other Significant

Regulatory Accounting: Regulatory

Legal Authority: 42 U.S.C. 1302; 42 U.S.C. 1395hh

CFR Citation: 42 CFR 488; 42 CFR 489

Legal Deadline: Final, Statutory, February 15, 2027, MMA sec. 902 requires Medicare final rules publish within 3 years of a proposed or interim final rule.

Per the CMS notice published December 30, 2004 (69 FR 78442), except for certain Medicare payment regulations and certain other statutorily-mandated regulations, we schedule all Medicare final regulations for publication within the 3-year standardized time limit in the current Unified Agenda. We do not intend to delay publishing a Medicare final regulation for 3 years if we are able to publish it sooner.

Abstract: This final rule sets forth a number of provisions to strengthen the oversight of accrediting organizations (AO) by addressing conflicts of interest, establishing consistent standards, processes and definitions, and updating the validation and performance standards systems.

Statement of Need: We seek to strengthen public trust in CMS-approved Accrediting Organization (AO) findings and to promote the health and safety of patients who receive services from Medicare and Medicaid-participating providers accredited by CMS-approved AOs. When AOs request and receive CMS approval to determine compliance for facilities they accredit and are deemed by CMS to meet federal requirements, they take on a public trust responsibility in their oversight of providers and suppliers across the country. CMS needs to hold these organizations accountable for that responsibility and to eliminate any corporate conflicts of interest. Patients need to be able to rely on the strength of that accreditation to be assured that their health care services will be safe and of high quality. Where there are gaps in that accreditation process, or where quality issues are not fully identified or investigated by the AO, it means that current and future patients may experience unnecessary harm or quality issues.

Summary of Legal Basis: This rule implements changes under 42 U.S.C. ( printed page 52852) 1302 and 1395hh (the Social Security Act).

Alternatives: In developing the policies contained in this rule, we considered several alternatives affecting AO fee-based consulting and the validation program. These alternatives will be described in the rule.

Anticipated Cost and Benefits: In developing this regulation, we carefully considered its potential effects including both costs and benefits. The overall benefit of this rule would be to improve CMS' oversight of the AOs and to improve the overall quality and safety of healthcare. More specifically, the benefits of this rule include the improvement of the validation process and anticipated reductions in the validation disparity rate, the additional performance measure and the implementation of plans of correction that would help AOs that have low performance measure scores to prepare a plan for how to improve their performance, and the prevention and removal of potential and actual conflicts of interest. We note that the generation of benefits is contingent upon behavior change, which entails costs, as having negligible costs would therefore be anticipated to have minimal benefits. As we move toward publication, estimates of costs and benefits will be included in the rule.

Risks: The changes to be finalized in this rule are intended to mitigate risks and improve patient care.

Timetable:

Action	Date	FR Cite
NPRM	02/15/24	89 FR 11996
NPRM Comment Period End	04/15/24
Final Action	02/00/27

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Michelle Geppi, Special Assistant, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Center for Clinical Standards and Quality, 7500 Security Boulevard, Baltimore, MD 21244

Phone: 410 786-4844

Email: michelle.geppi@cms.hhs.gov

RIN: 0938-AU88

HHS—CMS

61. • ESTABLISHING STATE COMMUNITY ENGAGEMENT REQUIREMENTS FOR CERTAIN INDIVIDUALS UNDER SECTION 1902(XX) OF THE SOCIAL SECURITY ACT (CMS-2454)

Priority: Economically Significant. Major under 5 U.S.C. 801.

Regulatory Accounting: Other

Unfunded Mandates: Undetermined

Legal Authority: Pub L 119-21, section 71119 ; Section 1902(xx) of the Social Security Act

CFR Citation: Not Yet Determined

Legal Deadline: Final, Statutory, June 1, 2026.

Section 71119 of Public Law 119-21 requires the agency to promulgate an interim final rule no later than June 1, 2026, to implement the requirements established by such section beginning January 1, 2027 (or earlier date at state option).

Abstract: Section 71119 (Requirement for States to Establish Medicaid Community Engagement Requirements for Certain Individuals) of Public Law 119-21 amended section 1902 of the Social Security Act (the Act) to add subsection (xx). Section 1902(xx) of the Act requires states and the District of Columbia to ensure that applicable individuals demonstrate, as a condition of their Medicaid eligibility, a minimum number of community engagement hours (generally, that they work, are enrolled in an educational program, complete community service, participate in a work program, or any combination thereof) for a minimum period of time preceding their application and during their enrollment. The requirements of section 1902(xx) of the Act are effective beginning January 1, 2027, unless a state opts to implement the requirements sooner. Section 71119 also requires the agency to promulgate an interim final rule to implement 1902(xx) of the Act no later than June 1, 2026.

Statement of Need: As required by statute, beginning January 1, 2027, states must condition eligibility for applicable individuals on their demonstration of community engagement (generally, that they work, are enrolled in an educational program, complete community service, participate in a work program, or any combination thereof, or meet an exception), unless a state opts to implement community engagement sooner.

Summary of Legal Basis: Section 71119 of the Working Families Tax Cut Act (Pub L. 119-21) requires that we promulgate an interim final rule to implement 1902(xx) of the Act no later than June 1, 2026.

Alternatives: None. This rule implements a statutory requirement.

Anticipated Cost and Benefits: As we move toward publication, estimates of costs and benefits will be included in the rule.

Risks: Risks associated with the impact of this rule are under development and will be included in the published rule.

Timetable:

Action	Date	FR Cite
Interim Final Rule	07/00/26

Regulatory Flexibility Analysis Required: No

Government Levels Affected: Federal, State

Federalism: This action may have federalism implications as defined in E.O. 13132.

Agency Contact: Jessica Stephens, Acting Deputy Director, Children and Adults Health Programs Group, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Center for Medicaid and CHIP Services, 7500 Security Blvd., Baltimore, MD 21244

Phone: 410 786-3341

Email: jessica.stephens@cms.hhs.gov

RIN: 0938-AV98

HHS—Administration for Children and Families (ACF)	Proposed Rule Stage

62. • REDUCING BUREAUCRACY AND BURDEN IN THE CHILD CARE AND DEVELOPMENT FUND (CCDF)

Priority: Economically Significant. Major status under 5 U.S.C. 801 is undetermined.

Regulatory Accounting: Deregulatory

Unfunded Mandates: Undetermined

Legal Authority: 42 U.S.C. 9857 et seq; 42 U.S.C. 618

Relevant Executive Orders: 14303; 14191; 14219

CFR Citation: CFR part 98 and 99

Legal Deadline: None

Abstract: This NPRM proposes to modify Child Care and Development Fund (CCDF) regulations to improve child care access and choice for families, reduce administrative burdens for states, territories, and Tribes, and provide additional flexibilities. The proposed changes would remove outdated provisions, significantly change requirements for Tribal CCDF programs, and streamline overly complicated and burdensome requirements for states and territories.

Statement of Need: This NPRM proposes to significantly reduce CCDF regulations (45 Part 98 and 99) to serve ( printed page 52853) more children and reduce costs and burden for states, territories, and Tribes administering the CCDF program. It builds upon the first deregulatory CCDF NPRM (RIN: 0970-AD20) by further promoting the Administration's interests and priorities around expanding parental choice, reducing bureaucratic red tape and regulatory burden, and prioritizing flexibility for states, territories, and Tribes. More specifically, this NPRM is in line with Executive Order (E.O.) 14192, Unleashing Prosperity Through Deregulation.

Summary of Legal Basis: This NPRM will be issued under the authority granted to the Secretary of Health and Human Services by the Child Care and Development Block Grant (CCDBG) Act of 1990, as amended (42 U.S.C. 9857, et seq.), and section 418 of the Social Security Act (42 U.S.C. 618).

Alternatives: TBD

Anticipated Cost and Benefits: ACF anticipates that this regulatory action would result in great cost savings for states, territories, and Tribes due to reduced administrative burden. ACF expects these savings would allow states, territories, and Tribes to serve additional children and families.

Risks: TBD

Timetable:

Action	Date	FR Cite
NPRM	11/00/26

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Federalism: Undetermined

Agency Contact: Megan Campbell, Supervisory Child Care Program Specialist, Department of Health and Human Services, Administration for Children and Families, Office of Child Care, 330 C Street SW, Washington, DC 20201

Phone: 202 690-6499

Fax: 202 690-5600

Email: megan.campbell@acf.hhs.gov

RIN: 0970-AD29

HHS—CMS

63. • MODERNIZE THE HEAD START PROGRAM BY REDUCING REQUIREMENTS AND ENHANCING ALIGNMENT WITH STATE AND LOCAL SYSTEMS

Priority: Other Significant. Major status under 5 U.S.C. 801 is undetermined.

Regulatory Accounting: Deregulatory

Unfunded Mandates: Undetermined

Legal Authority: Public Law 110-134, Sec. 641A, 645, and 645A

Relevant Executive Orders: 14303; 14242; 14219

CFR Citation: Not Yet Determined

Legal Deadline: None

Abstract: This NPRM proposes to reduce and streamline Head Start regulatory requirements, to align Head Start standards with state and local systems and reduce burden on Head Start programs. Regulatory changes will support the integration of Head Start programs and funding into state systems of early care and education.

Statement of Need: This NPRM proposes to modify the Head Start Program Performance Standards to significantly reduce regulatory requirements and better align Head Start standards with state and local systems. This NPRM will lower burden on Head Start programs and improve coordination with state early childhood systems. The NPRM also proposes to prioritize and strengthen the importance of nutrition and physical exercise in Head Start programs.

This builds upon the first deregulatory OHS NPRM by further promoting the Administration's interests and priorities around expanding parental choice, reducing bureaucratic red tape and regulatory burden, and prioritizing flexibility for states, territories, and Tribes. More specifically, this NPRM is in line with Executive Order (E.O.) 14192, Unleashing Prosperity Through Deregulation.

Summary of Legal Basis: This NPRM will be issued under the authority granted to the Secretary of Health and Human Services by the Head Start Act.

Alternatives: ACF has considered alternatives, including issuance of sub-regulatory guidance, but has determined that regulatory action is necessary to reduce burden on agencies administering the Head Start program and to promote choice for parents in the program. Sub-regulatory action alone is insufficient to overcome mandates and requirements included in existing regulations.

Anticipated Cost and Benefits: ACF anticipates that this regulatory action will result in cost savings for Head Start programs by reducing burden on grant recipients.

Risks: ACF expects this NPRM will be well-received by Head Start programs, since they will welcome reduced burden and increased flexibility. ACF expects that some providers, some state or regional associations, and child and family stakeholders may have some express hesitation with the removal or revision of certain requirements; however, the NPRM would generally allow flexibility to Head Start programs to implement policies that best address the needs of their communities with direct engagement with state and local entities.

Timetable:

Action	Date	FR Cite
NPRM	11/00/26

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Federalism: Undetermined

Agency Contact: Shawna Pinckney, Acting Deputy Director, Office of Head Start, Department of Health and Human Services, Administration for Children and Families, 330 C Street SW, Washington, DC 20416

Phone: 866 763-6481

Email: shawna.pinckney@acf.hhs.gov

RIN: 0970-AD30

HHS—ACF

64. • REFORMING FEDERAL REPORTING AND ASSESSMENTS IN CHILD WELFARE

Priority: Other Significant. Major status under 5 U.S.C. 801 is undetermined.

Regulatory Accounting: Not subject to, not significant

Unfunded Mandates: Undetermined

Legal Authority: Not Yet Determined

Relevant Executive Orders: 14270; 14219; 14303

CFR Citation: Not Yet Determined

Legal Deadline: None

Abstract: This NPRM would permit ACF to streamline the assessment and reporting scheme in the Children's Bureau.

Statement of Need: This NPRM proposes to simplify and restructure the overly bureaucratic array of reporting and monitoring systems that evaluate a state's compliance with federal child welfare requirements. This includes both the five-year Child and Family Services Plan (CFSP), the Annual Progress and Services Report (APSR), and the Child and Family Services Review (CFSR). The CFSR is a periodic review of a state's child welfare system, which no state has achieved substantial conformity under after three complete rounds of review of every state. As such, every state is on a Program Improvement Plan (PIP) to take corrective action to improve the CFSR's findings.

Unfortunately, the PIPs have also been ineffective, with states producing ( printed page 52854) worse results in each subsequent round of the CFSR. It is clear that the web of reviews and reporting associated with state child welfare monitoring is overly restrictive and prescriptive. This rulemaking seeks to address this issue and reform the compliance reviews from a check-the-box process to an outcomes-based approach directed towards a tailored goal of ensuring a safe, loving home for every American child.

Summary of Legal Basis: TBD

Alternatives: ACF has considered alternatives, including issuance of sub-regulatory guidance, but has determined that regulatory action is necessary to reduce burden on states who are responsible for complying with the current bureaucratic patchwork of reporting and assessments. Sub-regulatory action alone is insufficient to overcome the needlessly prescriptive mandates and requirements included in existing regulations.

Anticipated Cost and Benefits: ACF has calculated that the cost of administering the CFSR is roughly $600,000 per state, per round. A rewritten reporting and review process seeks to not only save administrative expenses, but will also allow states and ACF to spend time seeking to improve child welfare as opposed to following a failed bureaucratic process. This proposed rulemaking is set to save considerable administrative costs for both the states and ACF.

Risks: Risks are minimal. ACF expects this NPRM will be well-received by the community as few individuals see much of a benefit in the CFSR process, which since the turn of the century has identified zero states in substantial compliance. While with any changes in reporting requirements, there could be some initial hesitation, it is expected that stakeholders would be excited for compliance reporting to strengthen a component of child welfare, rather than waste hundreds of thousands of dollars per review which will lead to a pre-determined failure.

Timetable:

Action	Date	FR Cite
NPRM	07/00/26

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Federalism: Undetermined

Agency Contact: Adam Jones, Department of Health and Human Services, Administration for Children and Families, 330 C Street SW,

Washington, DC 20201

Phone: 202 417-0115

RIN: 0970-AD32

HHS—ACF

65. • REDUCING BUREAUCRACY AND BURDEN FOR CHILDREN, YOUTH AND FAMILIES

Priority: Other Significant. Major status under 5 U.S.C. 801 is undetermined.

Regulatory Accounting: Deregulatory

Unfunded Mandates: Undetermined

Legal Authority: Not Yet Determined

Relevant Executive Orders: 14219; 14303; 13563

CFR Citation: Not Yet Determined

Legal Deadline: None

Abstract: This NPRM would eliminate the Administration for Children and Families' obsolete and unnecessary regulations related to the Administration on Children, Youth and Families.

Statement of Need: This NPRM proposes to modify Administration Children, Youth and Families regulations to identify outdated and obsolete regulations, while also shining a brighter spotlight onto the regulations that remain in order to improve clarity and to support families, reduce administrative burdens for states, territories, and Tribes, and provide additional flexibilities. The proposed changes would remove outdated provisions and streamline requirements.

This action is necessary as ACF has amassed nearly 1,500 sections of regulations, some of which have not been amended or updated since the final year of the Johnson Administration. Without this intentional removal of dead-weight regulations, regulatory provisions can confuse and burden members of the public who are forced to abide by them.

Summary of Legal Basis: TBD

Alternatives: ACF has considered alternatives, including issuance of sub-regulatory guidance, but has determined that regulatory action is necessary to reduce burden on states, territories, and tribes who are currently saddled with dead weight text that presently remains on the books. Sub-regulatory action alone is insufficient to overcome outdated and obsolete mandates and requirements included in existing regulations.

Anticipated Cost and Benefits: The regulations that are to be repealed as a result of this rulemaking are obsolete, and thus currently impose limited cost. As a result, the financial cost associated with their removal will not necessarily result in saved dollars, but will rather provide clarity and ease confusion to grantees and the public who interact with ACF's regulations.

Risks: ACF expects this NPRM will be well-received by the community as this serves to eliminate unnecessary and obsolete regulations.

Timetable:

Action	Date	FR Cite
NPRM	07/00/26

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Federal, Local, State

Federalism: Undetermined

Agency Contact: Adam Jones, Department of Health and Human Services, Administration for Children and Families, 330 C Street SW, Washington, DC 20201

Phone: 202 417-0115

RIN: 0970-AD37

HHS—ACF

66. • REDUCING BUREAUCRACY AND BURDEN FOR FAMILY ASSISTANCE PROGRAMS

Priority: Other Significant. Major status under 5 U.S.C. 801 is undetermined.

Regulatory Accounting: Deregulatory

Unfunded Mandates: Undetermined

Legal Authority: Not Yet Determined

Relevant Executive Orders: 14219; 14303; 13563

CFR Citation: Not Yet Determined

Legal Deadline: None

Abstract: This NPRM would eliminate the Administration for Children and Families' obsolete and unnecessary regulations related to the Office of Family Assistance.

Statement of Need: This NPRM proposes to modify Office of Family Assistance regulations to identify outdated and obsolete regulations, while also shining a brighter spotlight onto the regulations that remain in order to support families, reduce administrative burdens for states, territories, and Tribes, and provide additional flexibilities. The proposed changes would remove outdated provisions and streamline requirements.

Summary of Legal Basis: TBD

Alternatives: ACF has considered alternatives, including issuance of sub-regulatory guidance, but has determined that regulatory action is necessary to reduce burden on states, territories, and tribes who are currently saddled with dead weight text that presently remains on the books. Sub-regulatory action alone is insufficient to overcome outdated and obsolete mandates and requirements included in existing regulations.

Risks: ACF expects this NPRM will be well-received by the community as this serves to eliminate unnecessary and obsolete regulations.

Timetable:

Action	Date	FR Cite
NPRM	07/00/26

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Federal, Local, State

Federalism: Undetermined

Agency Contact: Adam Jones, Department of Health and Human Services, Administration for Children and Families, 330 C Street SW, Washington, DC 20201

Phone: 202 417-0115

RIN: 0970-AD38

HHS—ACF

67. • REDUCING BUREAUCRACY AND BURDEN FOR CHILD SUPPORT ENFORCEMENT

Priority: Other Significant. Major status under 5 U.S.C. 801 is undetermined.

Regulatory Accounting: Deregulatory

Unfunded Mandates: Undetermined

Legal Authority: Not Yet Determined

Relevant Executive Orders: 14219; 14303; 13563

CFR Citation: Not Yet Determined

Legal Deadline: None

Abstract: This NPRM would eliminate the Administration for Children and Families' obsolete and unnecessary regulations related to the Office of Child Support Enforcement.

Statement of Need:

This NPRM proposes to modify Office of Child Support Enforcement regulations to identify outdated and obsolete regulations, while also shining a brighter spotlight onto the regulations that remain in order to improve clarity, reduce administrative burdens for states, territories, and Tribes, and provide additional flexibilities. The proposed changes would remove outdated provisions and streamline requirements.

Summary of Legal Basis: TBD

Alternatives: ACF has considered alternatives, including issuance of sub-regulatory guidance, but has determined that regulatory action is necessary to reduce burden on states, territories, and tribes who are currently saddled with dead weight text that presently remains on the books. Sub-regulatory action alone is insufficient to overcome outdated and obsolete mandates and requirements included in existing regulations.

Risks: ACF expects this NPRM will be well-received by the community as this serves to eliminate unnecessary and obsolete regulations.

Timetable:

Action	Date	FR Cite
NPRM	07/00/26

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Federal, Local, State

Federalism: Undetermined

Agency Contact: Adam Jones, Department of Health and Human Services, Administration for Children and Families, 330 C Street SW, Washington, DC 20201

Phone: 202 417-0115

RIN: 0970-AD39

HHS—ACF

68. • REDUCING BUREAUCRACY AND BURDEN IN COMMUNITY SERVICES

Priority: Other Significant. Major status under 5 U.S.C. 801 is undetermined.

Regulatory Accounting: Deregulatory

Unfunded Mandates: Undetermined

Legal Authority: Not Yet Determined

Relevant Executive Orders: 14219; 14303; 13563

CFR Citation: Not Yet Determined

Legal Deadline: None

Abstract: This NPRM would eliminate the Administration for Children and Families' obsolete and unnecessary regulations related to the Office of Community Services.

Statement of Need: This NPRM proposes to modify Office of Community Services regulations to identify outdated and obsolete regulations, while also shining a brighter spotlight onto the regulations that remain in order to improve support families, reduce administrative burdens for states, territories, and Tribes, and provide additional flexibilities. The proposed changes would remove outdated provisions and streamline requirements.

Summary of Legal Basis: TBD

Alternatives: ACF has considered alternatives, including issuance of sub-regulatory guidance, but has determined that regulatory action is necessary to reduce burden on states, territories, and tribes who are currently saddled with dead weight text that presently remains on the books. Sub-regulatory action alone is insufficient to overcome outdated and obsolete mandates and requirements included in existing regulations.

Risks: ACF expects this NPRM will be well-received by the community as this ( printed page 52856) serves to eliminate unnecessary and obsolete regulations.

Timetable:

Action	Date	FR Cite
NPRM	07/00/26

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Federal, Local, State

Federalism: Undetermined

Agency Contact: Adam Jones, Department of Health and Human Services, Administration for Children and Families, 330 C Street SW, Washington, DC 20201

Phone: 202 417-0115

RIN: 0970-AD41

HHS—ACF

69. • REDUCING BUREAUCRACY AND BURDEN IN FAMILY VIOLENCE AND PREVENTION SERVICES

Priority: Other Significant. Major status under 5 U.S.C. 801 is undetermined.

Regulatory Accounting: Deregulatory

Unfunded Mandates: Undetermined

Legal Authority: Not Yet Determined

Relevant Executive Orders: 14219; 14303; 13563

CFR Citation: Not Yet Determined

Legal Deadline: None

Abstract: This NPRM would eliminate the Administration for Children and Families' obsolete and unnecessary regulations related to the Office of Family Violence and Prevention Services.

Statement of Need: This NPRM proposes to modify Office of Family Violence and Prevention Services regulations to identify outdated and obsolete regulations, while also shining a brighter spotlight onto the regulations that remain in order to improve clarity and to support families, reduce administrative burdens for states, territories, and Tribes, and provide additional flexibilities. The proposed changes would remove outdated provisions and streamline requirements.

Summary of Legal Basis: TBD

Alternatives: ACF has considered alternatives, including issuance of sub-regulatory guidance, but has determined that regulatory action is necessary to reduce burden on states, territories, and tribes who are currently saddled with dead weight text that presently remains on the books. Sub-regulatory action alone is insufficient to overcome outdated and obsolete mandates and requirements included in existing regulations.

Risks: ACF expects this NPRM will be well-received by the community as this serves to eliminate unnecessary and obsolete regulations.

Timetable:

Action	Date	FR Cite
NPRM	07/00/26

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Federal, Local, State

Federalism: Undetermined

Agency Contact: Adam Jones, Department of Health and Human Services, Administration for Children and Families, 330 C Street SW, Washington, DC 20201

Phone: 202 417-0115

RIN: 0970-AD42

HHS—ACF	Final Rule Stage

70. • REDUCING BUREAUCRACY AND BURDEN FOR REFUGEE RESETTLEMENT PROGRAMS

Priority: Other Significant

Regulatory Accounting: Deregulatory

Legal Authority: Not Yet Determined

Relevant Executive Orders: 14219; 14303; 13563

CFR Citation: Not Yet Determined

Legal Deadline: None

Abstract: This DFR would eliminate the Administration for Children and Families' obsolete and unnecessary regulations related to the Office of Refugee Resettlement.

Statement of Need: This DFR proposes to modify Office of Refugee Resettlement regulations to identify outdated and obsolete regulations, while also shining a brighter spotlight onto the regulations that remain in order to support for families, reduce administrative burdens for states, territories, and Tribes, and provide additional flexibilities. The proposed changes would remove outdated provisions and streamline requirements.

Summary of Legal Basis: TBD

Alternatives: ACF has considered alternatives, including issuance of sub-regulatory guidance, but has determined that regulatory action is necessary to reduce burden on states, territories, and tribes who are currently saddled with dead weight text that presently remains on the books. Sub-regulatory action alone is insufficient to overcome outdated and obsolete mandates and requirements included in existing regulations.

Risks: ACF expects this DFR will be well-received by the community as this serves to eliminate unnecessary and obsolete regulations.

Timetable:

Action	Date	FR Cite
Direct Final Rule	07/00/26

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Federal, Local, State

Agency Contact: Adam Jones, Department of Health and Human Services, Administration for Children and Families, 330 C Street SW, Washington, DC 20201

Phone: 202 417-0115

RIN: 0970-AD28

BILLING CODE 4150-03-P

Department of Homeland Security (DHS)

2026 Statement of Regulatory Priorities

The Department of Homeland Security (DHS or Department) was established in 2003 pursuant to the Homeland Security Act of 2002, Public ( printed page 52857) Law 107-296. The DHS mission statement provides the following: “With honor and integrity, we will safeguard the American people, our homeland, and our values.”

Fulfilling that mission requires the dedication of more than 271,000 employees in jobs that range from aviation and border security to emergency response, from cybersecurity analyst to chemical facility inspector. Our duties are wide-ranging, but our goal is clear: keep America safe.

There are six overarching homeland security missions that make up DHS's strategic plan: (1) Counter terrorism and homeland security threats; (2) secure U.S. borders; (3) administer the nation's legal immigration system; (4) secure cyberspace and critical infrastructure; (5) strengthen preparedness and respond to incidents; and (6) combat crimes of exploitation and protect victims. See also 6 U.S.C. 111(b)(1) (identifying the primary mission of the Department).

In achieving those goals, we are committed to upholding and strengthening the nation's economic security and prosperity. We are continually strengthening our partnerships with communities, first responders, law enforcement, and Government agencies—at the Federal, State, local, tribal, and international levels. We are accelerating the deployment of science, technology, and innovation in order to make America more secure, and we are becoming leaner, smarter and more efficient, ensuring that every security resource is used as effectively as possible. For a further discussion of our mission, see the DHS website at www.dhs.gov/mission.

The regulations in the Department's 2026 regulatory plan and agenda support the Department's mission, and also address legislative initiatives such as those found in the One Big Beautiful Bill Act, the REAL ID Act, and the Implementing Recommendations of the 9/11 Commission Act of 2007.

In addition, the regulations advance the President's priorities as outlined in executive orders and presidential memoranda, including Executive Order 14165, Securing Our Borders; Executive Order 14159, Protecting the American People Against Invasion; and Executive Order 14267, Reducing Anti-Competitive Regulatory Barriers. Consistent with the priorities in these and related executive actions, the Department is strengthening the integrity of its immigration programs and ensuring that immigration benefits are only issued to aliens that establish eligibility after thorough screening and vetting. In this effort, DHS is enhancing vetting of aliens who seek to enter the United States and who apply for benefits such as work authorization or admission as students or exchange visitors. DHS is also working to reduce asylum fraud and backlogs, address vulnerabilities in the transportation system, guard against cyber-attacks and threats to critical infrastructure, reduce barriers to American innovation, and streamline operations across its components. DHS is committed to supporting fair competition in the marketplace and is pursuing actions to facilitate private-sector engagement in disaster response efforts and innovation in the technology sector. In addition, DHS is working to restore American dominance in the maritime industry by eliminating needless barriers to entry for mariners and outdated requirements for vessel owners and operators.

DHS is committed to reviewing existing regulations, consistent with Executive Orders 14192 and 14219, and to rescinding any regulations that may be contrary to the public interest or administration policy, or unduly burdensome on private enterprise. These actions will improve the Department's ability to accomplish its mission and support broader Administration priorities. In fiscal year 2026, based on current estimates, DHS has already or plans to finalize the following actions:

0Executive Order 14192 regulatory action;
24Executive Order 14192 deregulatory actions;
19Executive Order 14192-exempt regulations; and
2 additional regulations that do not yet have anExecutive Order 14192 designation.

DHS strives for organizational excellence and uses a centralized and unified approach to manage its regulatory resources. The Office of the General Counsel manages the Department's regulatory program, including the agenda and regulatory plan. In addition, DHS senior leadership reviews each significant regulatory project in order to ensure that the project fosters and supports the Department's mission.

The DHS 2026 regulatory plan includes regulations from multiple DHS components, including U.S. Citizenship and Immigration Services (USCIS), U.S. Immigration and Customs Enforcement (ICE), U.S. Coast Guard (Coast Guard), U.S. Customs and Border Protection (CBP), Transportation Security Administration (TSA), Cybersecurity and Infrastructure Security Agency (CISA) and Federal Emergency Management Agency (FEMA). Below, we describe the regulations that comprise the DHS 2026 regulatory plan.

United States Citizenship and Immigration Services

USCIS oversees lawful immigration to the United States. USCIS is restoring integrity to the legal immigration system by prioritizing enhanced screening and vetting to deter, detect, and disrupt immigration fraud and threats to our national security and public safety. In the coming year, USCIS will pursue regulatory actions to further these priorities and to fortify our ability to process and issue accurate and timely eligibility determinations in strict adherence to U.S. immigration law, regulations, and policy.

Improving the Process of Certification of Form N-648, Medical Certification for Disability Exceptions. DHS will propose to amend its regulations governing the process of certifying Form N-648, Medical Certification for Disability Exceptions, by certain medical professionals. Through this certification process, aliens qualify for exemptions from the English proficiency and civics requirements for naturalization. The proposed amendments seek to strengthen the safeguards designed to protect the integrity of the naturalization process and reduce the ability of medical professionals to exploit vulnerabilities in the process. These changes would ensure proper administration of the disability exception process by implementing streamlined certification procedures for Form N-648 requests.

Naturalization Application Fee Adjustments. DHS will propose to adjust the fees that USCIS charges for Form N-400, Application for Naturalization, and Form N-336, Request for a Hearing on a Decision in Naturalization Proceedings, eliminate the reduced fee option for Form N-400, and eliminate the availability of fee waivers for both forms. Adjusting these fees would allow USCIS to recover operating costs more fully and support the issuance of accurate and timely eligibility determinations. Armed forces service members filing under INA 328 or INA 329 would remain exempt from paying the fees when filing for naturalization under statutes for members of the armed forces.

Protecting the Integrity of Naturalization through Enhanced Educational Standards. DHS will propose to amend regulations governing the educational requirements for naturalization. Naturalization is the most significant immigration benefit offered by the U.S. and it is a privilege ( printed page 52858) that allows aliens to become fully vested members of American society, with important rights and responsibilities that all citizens should exercise and respect. DHS will propose to establish a framework and a standard for applicants to meet showing they have satisfied the educational requirements to ensure only those aliens who meet all eligibility requirements—including the ability to read, write, and speak English and an understanding of U.S. government and civics—are able to naturalize. DHS will also propose additional flexibilities to allow USCIS to modify the way it administers the naturalization test, including allowing third parties to administer the test.

Sponsor Reimbursement and Deeming. To uphold the rule of law, preserve hard-earned taxpayer resources, and protect benefits for American citizens in need,DHS will propose to amend its regulations relating to the mechanisms by which the Federal government, as well as the States and state agencies, hold the sponsors of aliens to their commitments to financially support those aliens. These amendments will include changes relating to requests for reimbursement and actions to compel reimbursement. DHS will also propose to amend its regulations to clarify the responsibilities of States and state agencies administering Federal means-tested public benefits to attribute a sponsor's income and resources to an alien when determining the eligibility and the amount of benefits of an alien for Federal means-tested public benefits programs. The goal is to hold individuals who have agreed to financially support aliens responsible for repaying American taxpayers for any means-tested public benefits received by those sponsored aliens.

United States Immigration and Customs Enforcement

ICE is the principal criminal investigative arm of DHS and one of the three DHS components charged with the criminal and civil enforcement of the Nation's immigration laws. ICE's primary mission is to enforce immigration laws in order to preserve national security and public safety, while also mitigating transnational threats and safeguarding our nation, communities, lawful immigration, trade, travel, and financial systems. During the coming year, ICE will focus on rulemakings that relate to foreign students, fees, and streamlining immigration processes in line with executive orders and Administration priorities. ICE highlights the rule below, which promotes fiscal responsibility and enhancing oversight of foreign student programs.

Establishing a Fixed Time Period of Admission and an Extension of Stay Procedure for Nonimmigrant Academic Students, Exchange Visitors, and Representatives of Foreign Information Media. On August 28, 2025, ICE proposed to amend the regulations governing the admission period of aliens in the F, J, and I classifications into the United States. Currently, aliens under those classifications are admitted into the United States for a period known as duration of status, which is an unspecified period of time, to engage in activities authorized under the alien's respective nonimmigrant classification. This rule will replace the duration of status framework with a fixed period of admission. This rule will ensure that DHS has an effective mechanism to periodically and directly assess whether these aliens are complying with the conditions of their classifications and U.S. immigration laws, while also addressing fraud and national security concerns.

United States Coast Guard

The Coast Guard is a military, multi-mission, maritime service of the United States and the only military organization within DHS. It is the principal Federal agency responsible for maritime safety, security, and stewardship in U.S. ports and waterways. The Coast Guard delivers daily value to the nation through its unique resources, authorities, and capabilities.

The United States is a maritime nation, and our security, resilience, and economic prosperity are intrinsically linked to the oceans. Safety, efficient waterways, and freedom of transit on the high seas are essential to our well-being. The Coast Guard is leaning forward, poised to meet the demands of the modern maritime environment. The Coast Guard creates value for the public through solid prevention and response efforts. Activities involving oversight and regulation, enforcement, maritime presence, and public and private partnership foster increased maritime safety, security, and stewardship. The Coast Guard supports the Department's overarching goals of mobilizing and organizing our Nation to secure the homeland from terrorist attacks, natural disasters, and other emergencies.

To empower its deregulatory endeavors, the Coast Guard has established over a dozen Process Improvement Teams (Deregulatory PIT Crews) that identified dozens of deregulatory ideas. The Coast Guard is deregulating through guidance documents, legislative change proposals, legacy stakeholder ideas, leveraging AI, program evaluation and evidence building, information collection requests, and several maritime sectors specific to Coast Guard jurisdiction. In fiscal year 2026, the Coast Guard plans to finalize the following 3 deregulatory actions.

Clarification of Certain Mariner Training Requirements. The Coast Guard will propose to remove certain Coast Guard merchant mariner requirements related to International Convention on Standards of Training, Certification and Watchkeeping for Seafarers, 1978, as amended (STCW) and the Seafarer's Training Certification and Watchkeeping Code endorsements from its regulations. The Coast Guard has determined these training requirements exceed current international certification and training standards of the STCW and cause a misalignment between the training of U.S. mariners and of mariners of other countries. The Coast Guard is taking this action to reduce the regulatory burden on U.S. mariners and to promote equivalent compliance standards with international requirements.

Electronic Chart and Navigation Equipment Carriage Requirements. This deregulatory action will revise regulations associated with the approval and carriage of navigation equipment, navigational charts, and publications. It will allow the use of electronic navigational charts and publications and certain classes of electronic charting systems to meet navigational equipment carriage requirements. This action will align Coast Guard regulations with current industry behavior. By establishing clear and updated standards for both paper and electronic navigational charts and systems, the Coast Guard regulations will reflect technological advancements and operational practices adopted by the maritime industry, and it will make navigational charting easier for the mariner.

Shipping Safety Fairways Along the Atlantic Coast. The Coast Guard published a notice of proposed rulemaking on January 19, 2024 to establish shipping safety fairways and other routing measures along the Atlantic Coast. The Coast Guard will reopen the comment period to request comments on a supplemental regulatory analysis and draft programmatic environmental impact statement. Fairways are marked routes for vessel traffic in which any obstructions are prohibited. The proposed fairways will be based on studies about vessel traffic along the Atlantic Coast. This action ( printed page 52859) would ensure that obstruction-free routes are preserved to and from US ports and along the Atlantic coast; reduce the risk of collisions, allisions and grounding; and alleviate the chance of increased time and expenses in transit. These routing measures would facilitate the direct and unobstructed transit of ships, and the Coast Guard believes that the assurances such routing measures provide would allow for improved medium- and long-term planning strategies, further serving shipping companies and their vessels.

United States Customs and Border Protection

CBP is the DHS agency principally responsible for the security of our Nation's borders, both at and between the ports of entry into the United States. CBP must accomplish its border security and enforcement mission without stifling the flow of legitimate trade and travel. The primary mission of CBP is its homeland security mission, that is, to prevent terrorists and terrorist weapons from entering the United States. An important aspect of this mission involves improving security at our borders and ports of entry, but it also means extending our zone of security beyond our physical borders.

CBP also administers laws concerning the importation of goods into the United States and enforces the laws concerning the entry of persons into the United States. This includes regulating and facilitating international trade; collecting import duties; enforcing U.S. trade, immigration, and other laws of the United States at our borders; inspecting imports; overseeing the activities of persons and businesses engaged in importing; enforcing the laws concerning smuggling and trafficking in contraband; apprehending aliens attempting to enter the United States illegally; protecting our agriculture and economic interests from harmful pests and diseases; servicing all people, vehicles, and cargo entering the United States; maintaining export controls; and protecting U.S. businesses from theft of their intellectual property.

The Homeland Security Act of 2002 provides that, although many functions of the former U.S. Customs Service were transferred to DHS, the Secretary of Treasury retains legal authority over customs revenue functions. By Treasury Department Order No. 100-20, the Secretary of the Treasury delegated to the Secretary of Homeland Security authority to prescribe regulations pertaining to the customs revenue functions. CBP plans to prioritize customs revenue-related regulations that streamline CBP procedures, protect the public, or are required by either statute or executive order.

CBP intends to issue several regulations to improve security at our borders and ports of entry as well as facilitate lawful trade. During the upcoming year, CBP will also work on projects to streamline CBP processing, reduce duplicative processes, reduce burdens on the public, and automate paper forms.

Homeland Security Functions

Advance Passenger Information System (APIS): Electronic Validation of Travel Documents. CBP intends to amend current APIS regulations to incorporate additional carrier requirements. This change would further enable CBP to determine whether each passenger is traveling with valid, authentic travel documents prior to the passenger boarding the aircraft. This rule is deregulatory and will result in time savings to passengers and cost savings to CBP. The rule will also enhance national security, because it will require air carriers to transmit to CBP additional data elements regarding contact information for all commercial aircraft passengers arriving in the United States. CBP also expects that the collection of these elements would support border operations and the Center for Disease Control and Prevention's mission in monitoring and tracing the contacts for persons involved in health incidents.

Automated Commercial Environment (ACE) Electronic Export Manifest for Rail Cargo. This rule will enhance national security by requiring exporters transporting cargo by rail to submit export manifest data electronically to CBP in the ACE. CBP officers are able to review electronic manifests faster than paper manifests, and so the rule would reduce the time burden for CBP, carriers, and transmitters.

Customs Revenue Functions

Elimination of Paper-Based Bond Applications and the Automated Processing of Bond Applications. CBP will propose to replace the paper-based bond application and approval process with an electronic process. The proposed rule would implement the successful National Customs Automation Program test of the electronic bond process.

Transportation Security Administration

TSA protects the Nation's transportation systems to ensure freedom of movement for people and commerce. TSA applies an intelligence-driven, risk-based approach to all aspects of its mission. This approach results in layers of security to mitigate risks effectively and efficiently.

TSA has prioritized regulatory actions that are required to meet statutory mandates, necessary for national and homeland security, and consistent with the goals of Executive Order 14192, Unleashing Prosperity Through Deregulation and other Administration priorities. In fiscal year 2026, TSA plans to issue the following three deregulatory and security-related actions.

Update to Procedures for State Certification for Remote Application and Issuance. This deregulatory rule would reduce burdens for individuals to apply for REAL ID-compliant driver's licenses and identification cards by establishing a procedure for TSA to approve States' remote application and issuance processes. Enabling remote processes will eliminate the need for individuals to travel to Departments of Motor Vehicle (DMV) offices and may reduce the burden on States to provide resources at DMV offices for in-person processing. This rulemaking is necessary to implement authority under the REAL ID Modernization Act, which authorized electronic submission of information and remote issuance of REAL ID cards under regulations prescribed by the Secretary of Homeland Security. States currently certified as meeting REAL ID standards would need to update their REAL ID certification documentation to confirm that their remote processes meet, or are comparable to, the existing standards. By enabling REAL ID application and issuance processes to conform to the modern modalities of electronic transactions with which the public is already familiar, this rule would accelerate and expand adoption of REAL ID-compliant cards.

Unmanned Aircraft Systems Beyond Visual Line of Sight Operations Security. This final rule is intended to provide a predictable and clear pathway for private industry to engage in safe, routine, and scalable unmanned aircraft systems (UAS) operations that include package delivery, agriculture, aerial surveying, operations training, demonstration, recreation, and flight testing. On June 6, 2025, the President issued Executive Order 14305, Restoring American Airspace Sovereignty, which noted the public safety benefits and security risks associated with UAS and also required Federal agencies to address the serious threats to our homeland that could be conducted if a UAS is weaponized. Concurrently, the President issued Executive Order 14307, Unleashing American Drone Dominance, which requires the Federal Aviation Administration (FAA) to issue ( printed page 52860) a final rule to enable beyond visual line of sight UAS operations for commercial and public safety purposes. In August 2025, TSA and FAA issued a joint proposed rule. TSA is working on a final rule, which it will issue in conjunction with FAA's final rule. The rule is an enabling rule as it will enable operations that are generally prohibited currently. While there may be costs associated in complying with mitigating security requirements necessary to permit these operations, the overall impact is expected to be deregulatory.

Vetting of Certain Surface Transportation Employees. This final rule will establish the requirements and procedures to conduct the vetting of certain higher-risk railroad, public transportation, and over-the-road bus employees, and to recover the costs of the vetting services. This rulemaking is required by the Implementing Recommendations of the 9/11 Commission Act, and it will enhance the security of surface transportation by ensuring that workers who are central to operations do not pose a threat to transportation or national security, or of terrorism. The final rule will address the public comments that TSA received in response to the May 2023 proposed rule.

Cybersecurity and Infrastructure Security Agency

CISA leads the national effort to understand, manage, and reduce risk to the cyber and physical infrastructure that Americans rely on every hour of every day. CISA's mission expands across three primary areas: cybersecurity, infrastructure security, and emergency communications.CISA is the operational lead for federal cybersecurity and the national coordinator for critical infrastructure security and resilience.

Cybersecurity Incident Reporting for Critical Infrastructure Act (CIRCIA) Reporting Requirements. In March 2022, CIRCIA was signed into law. CIRCIA directs CISA to develop and implement regulations requiring covered entities to submit reports to CISA regarding covered cyber incidents and ransom payments. CISA published a proposed rule on April 4, 2024. CISA received significant public comments, many of which emphasized the need to reduce the scope and burden of the reporting requirements, improve harmonization with other federal cyber incident reporting requirements, and ensure clarity. CISA is working to address Congressional intent and streamline CIRCIA's requirements, consistent with feedback to the NRPM.

Federal Emergency Management Agency

FEMA is responsible for helping the American people before, during, and after disasters. FEMA supports the people and communities of our Nation by providing experience, perspective, and resources in emergency management. FEMA is particularly focused on national resilience in the face of the risks of flooding, drought, extreme heat, and wildfire. FEMA has made a series of efforts to make assistance available promptly to those who need it, and to reduce administrative barriers and burdens. FEMA continues to prioritize those efforts and to improve them.

FEMA is working on deregulatory actions and has included certain ones in the 2026 Agenda. FEMA also plans to revise or repeal guidance documents and information collections to streamline program implementation and reduce burdens on the public. Additionally, FEMA is awaiting the recommendations of the FEMA Review Council, which was established by Executive Order 14180 (January 24, 2025).

Removal of Updates to Floodplain Management and Protection of Wetlands Regulations. FEMA plans to rescind the July 11, 2024 final rule, Updates to Floodplain Management and Protection of Wetlands Regulations to Implement the Federal Flood Risk Management Standard (FFRMS). This action is consistent with Executive Order 14148, Initial Rescissions of Harmful Executive Orders and Actions (January 20, 2025), which rescinded the executive order that had established the FFRMS. On March 25, 2025, FEMA stopped implementation of the FFRMS. FEMA is undertaking rulemaking to remove the FFRMS from its regulations. Removing the standard will streamline FEMA's regulations, streamline program implementation, reduce Federal spending, minimize transfers, and reduce burdens on the public.

BILLING CODE 9110-9B-P

DHS—U.S. Citizenship and Immigration Services (USCIS)	Proposed Rule Stage

1. • IMPROVING THE PROCESS OF CERTIFICATION OF FORM N-648, MEDICAL CERTIFICATION FOR DISABILITY EXCEPTIONS [1615-AD07]

Priority: Other Significant. Major status under 5 U.S.C. 801 is undetermined.

Regulatory Accounting: Fully or Partially Exempt

Unfunded Mandates: Undetermined

Legal Authority: 8 U.S.C. 1103; 8 U.S.C. 1423; 8 U.S.C. 1443

Relevant Executive Orders: 14161

CFR Citation: 8 CFR part 312; 8 CFR 106.2; 8 CFR part 336

Legal Deadline: None

Abstract: DHS proposes to amend its regulations governing the process of certifying Form N-648, Medical Certification for Disability Exceptions by certain medical professionals. Through this certification process, aliens qualify for exemptions from the English proficiency and civics requirements for naturalization. The proposed amendments seek to strengthen the integrity of the naturalization process by implementing streamlined certification procedures for medical professionals and ensuring that only qualified aliens are granted exemptions. These changes are intended to enhance safeguards designed to prevent fraudulent submissions and ensure proper administration of disability exception process for naturalization.

Statement of Need: Across the country and over the decades, there have been numerous instances where the medical certification process has been exploited. Some medical professionals have been arrested, indicted and convicted for submitting fraudulent Forms N-648 in violation of various federal statutes. This rule is intended to mitigate some of the concerns with the exploitation of the Form N-648 process, thereby further enhancing the integrity of naturalization process.

Anticipated Cost and Benefits: DHS is currently considering the specific impacts of the proposed provisions.

Timetable:

Action	Date	FR Cite
NPRM	07/00/26

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Federalism: Undetermined

Agency Contact: Mark Phillips, Residence and Naturalization Division Chief, Department of Homeland Security, U.S. Citizenship and Immigration Services, Office of Policy and Strategy, 5900 Capital Gateway Drive, Suite 4S190, Camp Springs, MD 20588-0009

Phone: 240 721-3000

RIN: 1615-AD07

DHS—USCIS

( printed page 52861)

2. • NATURALIZATION APPLICATION FEE ADJUSTMENTS [1615-AD08]

Priority: Other Significant. Major status under 5 U.S.C. 801 is undetermined.

Regulatory Accounting: Fully or Partially Exempt

Unfunded Mandates: Undetermined

Legal Authority: 8 U.S.C. 1356(m), (n)

CFR Citation: 8 CFR 106.2; 8 CFR 106.3

Legal Deadline: None

Abstract: DHS is proposing to adjust the fees that USCIS charges for Form N-400 and Form N-336 to ensure recovery of the cost of adjudication. This includes eliminating fee waivers (except for armed forces service members when filing for naturalization under statutes for members of the armed forces) and reduced fees for these forms.

Statement of Need: These proposed changes provide additional resources to further support USCIS's financial sustainability and provide additional resources for continued review of the integrity of the naturalization process.

Alternatives: DHS is currently considering the specific impacts of the proposed provisions.

Anticipated Cost and Benefits: DHS is currently considering the specific impacts of the proposed provisions.

Timetable:

Action	Date	FR Cite
NPRM	03/00/26

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Federalism: Undetermined

Phone: 240 721-3000

RIN: 1615-AD08

DHS—USCIS

3. • PROTECTING THE INTEGRITY OF NATURALIZATION THROUGH ENHANCED EDUCATIONAL STANDARDS [1615-AD13]

Priority: Other Significant. Major status under 5 U.S.C. 801 is undetermined.

Regulatory Accounting: Fully or Partially Exempt

Unfunded Mandates: Undetermined

Legal Authority: 8 U.S.C. 1103; 8 U.S.C. 1423; 8 U.S.C. 1443

Relevant Executive Orders: 14161

CFR Citation: 8 CFR part 312, 8 CRF part 316, 8 CFR part 3

Legal Deadline: None

Abstract: DHS proposes to amend its regulations governing the educational requirements for naturalization. DHS proposes to establish a framework and a standard for applicants to meet the educational requirements for naturalization. With this proposed rule, USCIS is seeking to further enhance the integrity of the naturalization test. DHS also proposes additional flexibilities to allow USCIS to modify the way it administers the naturalization tests, including by allowing for third party administration of the test.

Statement of Need: Aliens applying for naturalization must demonstrate an understanding of the English language, including an ability to read, write, and speak words in ordinary usage (English language requirements). Aliens must also demonstrate a knowledge and understanding of the fundamentals of the history, and of the principles and form of government, of the United States (civics requirements). Current regulations do not provide specifics on how aliens should meet the educational requirements. These changes would ensure the proper assimilation of lawful immigrants into the United States and promote a unified American identity and attachment to the Constitution, laws, and founding principles of the United States. With this proposed rule, USCIS is seeking to further enhance the integrity of the naturalization test and provide additional flexibilities in administering the naturalization test. Current regulations limit the administration of the naturalization test by requiring the test as part of the naturalization application and interview with an officer.

Anticipated Cost and Benefits: DHS is currently considering the specific impacts of the proposed provisions.

Timetable:

Action	Date	FR Cite
NPRM	07/00/26

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Federalism: Undetermined

Phone: 240 721-3000

RIN: 1615-AD13

DHS—USCIS

4. • SPONSOR REIMBURSEMENT AND DEEMING 8 CFR 213A [1615-AD15]

Priority: Other Significant. Major status under 5 U.S.C. 801 is undetermined.

Regulatory Accounting: Fully or Partially Exempt

Unfunded Mandates: Undetermined

Legal Authority: INA 213A (8 U.S.C. 1183a); 8 U.S.C. 1631; 8 U.S.C. 1632

CFR Citation: 8 CFR 213a

Legal Deadline: None

Abstract: DHS proposes to amend its regulations relating to the mechanisms by which the Federal government, as well as the States and state agencies, hold the sponsors of aliens to their commitments to financially support those aliens. The project will include amendments relating to requests for reimbursement and actions to compel reimbursement. DHS will also amend its regulations to clarify the responsibilities of States and state agencies to attribute a sponsor's income and resources to an alien when determining the eligibility and the amount of benefits of an alien for means-tested public benefits programs.

Statement of Need: Existing regulations relating to sponsor reimbursement and deeming fail to adequately convey the steps that States and state agencies must take to comply with their statutory obligations. These regulations would better aid States and state agencies in fulfilling those obligations, and expand the Federal role in forcing sponsors to financially support the sponsored aliens and reimburse the expenses associated with public benefit use by those aliens.

Anticipated Cost and Benefits: DHS is currently considering the specific impacts of the proposed provisions.

Timetable:

Action	Date	FR Cite
NPRM	03/00/26

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Federalism: Undetermined

Agency Contact: Mark Phillips, Residence and Naturalization Division Chief, Department of Homeland Security, U.S. Citizenship and Immigration Services, Office of Policy ( printed page 52862) and Strategy, 5900 Capital Gateway Drive, Suite 4S190, Camp Springs, MD 20588-0009

Phone: 240 721-3000

RIN: 1615-AD15

DHS—U.S. Coast Guard (USCG)	Proposed Rule Stage

5. SHIPPING SAFETY FAIRWAYS ALONG THE ATLANTIC COAST [1625-AC57]

Priority: Other Significant

Regulatory Accounting: Deregulatory

Legal Authority: 46 U.S.C. 70001; 46 U.S.C. 70003; 46 U.S.C. 70034

Relevant Executive Orders: 14269

CFR Citation: 33 CFR 166; 33 CFR 167

Legal Deadline: None

Abstract: The Coast Guard is proposing the establishment of shipping safety fairways along the Atlantic Coast of the United States. Fairways are marked routes for vessel traffic in which any fixed obstructions are prohibited. The proposed fairways are based on studies about vessel traffic along the Atlantic Coast and do not conflict with other ocean users. Coast Guard establishes shipping safety fairways to maintain safe and secure access to major ports of the U.S. Marine Transportation System.

Statement of Need: This rulemaking would establish shipping safety fairways along the Atlantic Coast of the United States to facilitate the direct and unobstructed transits of ships and facilitate development on the outer continental shelf. The rulemaking would also establish traffic separation schemes, precautionary areas, and a fairway anchorage. The establishment of these routing measures would ensure that obstruction-free routes are preserved to and from US ports and along the Atlantic Coast.

Anticipated Cost and Benefits: Establishing fairways would streamline interagency coordination between the Coast Guard, the Bureau of Ocean Energy Management, and other stakeholders during the wind energy leasing process. By clearly identifying historic vessel travel lanes and areas with high vessel traffic early on, this rule would enable efficient communication and decision-making. Additionally, it would provide clarity on less-trafficked, open-water areas suitable for future energy exploration projects, facilitating quicker and more effective planning. Coast Guard is determining the costs of the rule.

Timetable:

Action	Date	FR Cite
ANPRM	06/19/20	85 FR 37034
ANPRM Comment Period End	08/18/20
NPRM	01/19/24	89 FR 3587
Notification of Public Meeting; Extension of Comment Period	03/25/24	89 FR 20582
NPRM Comment Period Extended End	05/17/24
NPRM Comment Period Reopened	03/00/26
Final Rule	11/00/26

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: None

URL For More Information: www.regulations.gov

URL For Public Comments: www.regulations.gov

Agency Contact: Maureen Kallgren, Program Manager, Department of Homeland Security, U.S. Coast Guard, Office of Navigation Systems (CG-NAV), 2703 Martin Luther King Jr. Avenue SE, STOP 7509, Washington, DC 20593-7509

Phone: 571 608-5384

Email: maureen.r.kallgren2@uscg.mil

RIN: 1625-AC57

DHS—U.S. Customs and Border Protection (USCBP)	Final Rule Stage

6. ADVANCE PASSENGER INFORMATION SYSTEM: ELECTRONIC VALIDATION OF TRAVEL DOCUMENTS [1651-AB43]

Priority: Other Significant

Regulatory Accounting: Deregulatory

Legal Authority: 49 U.S.C. 44909; 8 U.S.C. 1221; 19 U.S.C. 1431

CFR Citation: 19 CFR 122

Legal Deadline: None

Abstract: U.S. Customs and Border Protection (CBP) regulations require commercial air carriers to electronically transmit passenger information to CBP's Advance Passenger Information System (APIS) prior to an aircraft's arrival in or departure from the United States. CBP proposed to incorporate additional carrier requirements that would enable CBP to validate each passenger's travel documents prior to the passenger boarding the aircraft. The proposed changes, if implemented, would also require air carriers to transmit additional data elements through APIS for all commercial aircraft passengers arriving in the United States in order to support border operations and national security. This rule is deregulatory and will result in time savings to passengers and cost savings to CBP.

Statement of Need: This Rule is needed to increase the safety of the traveling public, the air carrier industry, and the United States.

Anticipated Cost and Benefits: DHS is currently considering the specific impacts of the proposed provisions. Based on the analysis for the NPRM, DHS estimates this rule will result in an annualized net benefit of approximately $1 million due to time savings for CBP and travelers who will now be able to correct errors immediately.

Timetable:

Action	Date	FR Cite
NPRM	02/02/23	88 FR 7016
NPRM Comment Period End	04/03/23
Final Action	04/00/26

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

URL For More Information: www.regulations.gov

URL For Public Comments: www.regulations.gov

Agency Contact: Robert Neumann, Program Manager, Office of Field Operations, Department of Homeland Security, U.S. Customs and Border Protection, 1300 Pennsylvania Avenue NW, Washington, DC 20229

Phone: 202 412-2788

Email: robert.m.neumann@cbp.dhs.gov

RIN: 1651-AB43

DHS—USCBP

7. AUTOMATED COMMERCIAL ENVIRONMENT (ACE) ELECTRONIC EXPORT MANIFEST FOR RAIL CARGO [1651-AB52]

Priority: Other Significant

Regulatory Accounting: Deregulatory

Legal Authority: 19 U.S.C. 1415

CFR Citation: 123.93

Legal Deadline: None

Abstract: This rulemaking proposes to create a new regulation requiring the submission of export manifest data electronically to U.S. Customs and Border Protection (CBP) in the Automated Commercial Environment (ACE) for cargo transported by rail pursuant to section 343(a), of the Trade Act of 2002, as amended (19 U.S.C. 1415), for any train departing the United States. The proposed regulation would mandate the electronic transmission of rail export manifest information, identify the parties eligible to transmit information, describe the time frames prior to departure of the train in which ( printed page 52863) the information is due, and identify an initial filing that must occur 24 hours prior to departure from the port of export while requiring that remaining data be transmitted at least two hours prior to such departure. This rule is deregulatory and will result in both time savings and cost savings for carriers, transmitters, and CBP.

Statement of Need: This Rule is needed to address important cargo security concerns while providing efficiencies to the trade.

Anticipated Cost and Benefits: Based on the analysis for the NPRM, CBP expects that this rule would result in a present value total combined net cost savings of $49.8 million using a two percent discount rate, or approximately $3.8 million annualized (2023 U.S. dollars) to CBP, outbound rail carriers and other related parties during the period of analysis (2016 to 2030). CBP anticipates that this proposed rule would also provide added benefits from enhanced cargo security measures by improving compliance and the enforcement of U.S. export laws and regulations on U.S. rail exports, while also improving the facilitation of the export process.

Timetable:

Action	Date	FR Cite
NPRM	01/13/25	90 FR 2874
NPRM Comment Period End	03/14/25
Final Rule	04/00/26

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

International Impacts: This regulatory action will be likely to have international trade and investment effects, or otherwise be of international interest.

URL For More Information: www.regulations.gov

URL For Public Comments: www.regulations.gov

Agency Contact: Thomas Pagano, Chief, Outbound Enforcement Branch, Department of Homeland Security, U.S. Customs and Border Protection, Office of Field Operations, 1300 Pennsylvania Ave NW, Washington, DC 20229

Phone: 202 344-3277

Email: cbpexportmanifest@cpb.dhs.gov

RIN: 1651-AB52

DHS—Transportation Security Administration (TSA)	Final Rule Stage

8. VETTING OF CERTAIN SURFACE TRANSPORTATION EMPLOYEES [1652-AA69]

Priority: Other Significant

Regulatory Accounting: Regulatory

Legal Authority: 49 U.S.C. 114; Pub. L. 108-90, sec. 520; Pub. L. 110-53, secs. 1411, 1414, 1512, 1520, 1522, and 1531

Relevant Executive Orders: 14157; 14159; 14161; 14165

CFR Citation: 49 CFR 1500 ; 49 CFR 1530; 49 CFR 1570; 49 CFR 1572; 49 CFR 1580; 49 CFR 1582; 49 CFR 1584; . . .

Legal Deadline: Other, Statutory, August 3, 2008, background and immigration status check for all public transportation and railroad frontline employees is due no later than 12 months after date of enactment.

Sections 1411 and 1520 of Pub. L. 110-53, Implementing Recommendations of the 9/11 Commission Act of 2007 (9/11 Act), (121 Stat. 266, Aug. 3, 2007), require background checks of frontline public transportation and railroad employees not later than one year from the date of enactment. Requirement will be met through regulatory action.

Abstract: TSA will finalize regulations to establish the requirements and procedures to conduct the vetting of certain railroad, public transportation, and over-the-road bus employees, and to recover the costs of the vetting services. On May 23, 2023, TSA issued a notice of proposed rulemaking proposing these standards. TSA is evaluating all comments received and will publish the final rule. This regulation is related to 1652-AA55, Security Training for Surface Transportation Employees.

Statement of Need: This rulemaking is required by the Implementing Recommendations of the 9/11 Commission Act, Pub. L. 110-53, (121 Stat. 266, Aug. 3, 2007), and will enhance the security of surface transportation by ensuring that workers who are central to operations do not pose a threat to transportation or national security, or of terrorism.

Anticipated Cost and Benefits: The vetting of railroad, public transportation, and over-the-road bus employees covered under the rule will result in costs to TSA and to industry. TSA is required to recover vetting costs by collecting user fees from the individuals who are subject to the requirements rather than the public at large. TSA also anticipates ancillary costs ( e.g. updating contact information, compliance inspections) associated with compliance with the rule. Anticipated benefits include reducing security risks by identifying and/or mitigating potential insider threats through vetting.

Timetable:

Action	Date	FR Cite
NPRM	05/23/23	88 FR 33472
NPRM Comment Period End	08/21/23
NPRM Extension of Comment Period	08/22/23	88 FR 57044
NPRM Extension Comment Period End	10/01/23
Final Rule	11/00/26

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses, Governmental Jurisdictions, Organizations

Government Levels Affected: Local

URL For More Information: www.regulations.gov

URL For Public Comments: www.regulations.gov

Agency Contact: Ashlee Marks, Section Chief, Policy Development Section, Surface Policy Division, Department of Homeland Security, Transportation Security Administration, Policy, Plans, and Engagement, 6595 Springfield Center Drive, Springfield, VA 20598-6028

Phone: 571 227-3740

Email: ashlee.marks@tsa.dhs.gov

James Ruger, Chief Economist, Economic Analysis Branch-Coordination & Analysis Division, Department of Homeland Security, Transportation Security Administration, Policy, Plans, and Engagement, 6595 Springfield Center Drive, Springfield, VA 20598-6028

Phone: 571 227-5519

Christine Beyer, Senior Counsel, Regulations and Security Standards, Department of Homeland Security, Transportation Security Administration, Chief Counsel's Office, 6595 Springfield Center Drive, Springfield, VA 20598-6002

Phone: 571 227-3653

Email: christine.beyer@tsa.dhs.gov

Related RIN: Related to 1652-AA55, Related to 1652-AA56

RIN: 1652-AA69

DHS—TSA

( printed page 52864)

9. MINIMUM STANDARDS FOR DRIVER'S LICENSES AND IDENTIFICATION CARDS ACCEPTABLE BY FEDERAL AGENCIES FOR OFFICIAL PURPOSES; PROCEDURES FOR REMOTE APPLICATION AND ISSUANCE [1652-AA78]

Priority: Other Significant. Major status under 5 U.S.C. 801 is undetermined.

Regulatory Accounting: Deregulatory

Legal Authority: 49 U.S.C. 30301 note; 6 U.S.C. 111, 112; 49 U.S.C. 114

Relevant Executive Orders: 14159; 14161; 14165

CFR Citation: 6 CFR 37

Legal Deadline: None

Abstract: TSA is amending regulations implementing the REAL ID Act by issuing a procedural final rule that enables individuals to apply for, and for States to issue, REAL ID-compliant driver's licenses and identification cards remotely. The final rule requires States that elect to implement remote systems to update their existing REAL ID certification documentation to demonstrate how their remote systems meet, or are comparable to, existing standards of this part. Remote processes would eliminate the need for individuals to travel to Departments of Motor Vehicle offices and enable States to reduce support personnel at those offices. By reducing application and issuance burdens on individuals and States, this rule accelerates and expands adoption of REAL ID-compliant cards.

Statement of Need: This rulemaking is necessary to implement authority under the REAL ID Modernization Act, Section 1001 of Title X, Consolidated Appropriations Act, 2021, Pub. L. 116-260 (Dec. 27, 2020), which authorized electronic submission of information and remote issuance of REAL ID cards under regulations prescribed by the Secretary.

Anticipated Cost and Benefits: Allowance of a REAL ID remote issuance process will result in costs to States and TSA and cost savings for individuals. Individuals will realize cost savings from avoiding travel to the State Department of Motor Vehicles. States and TSA will incur administrative costs associated with submitting and reviewing remote issues applications. States may also incur costs to develop and implement remote issuance processes as well as potential cost savings associated with offering a fully remote option. Anticipated benefits include increased efficiencies as well as the acceleration and potential expansion of REAL ID adoption.

Timetable:

Action	Date	FR Cite
Final Action	11/00/26

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: Federal, State

URL For More Information: www.regulations.gov

URL For Public Comments: www.regulations.gov

Agency Contact: Anurag Maheshwary, Attorney Advisor, Department of Homeland Security, Transportation Security Administration, Regulations and Security Standards, 6595 Springfield Center Drive, Springfield, VA 20598

Phone: 571 227-4812

Email: anurag.maheshwary@tsa.dhs.gov

Phone: 571 227-5519

George Petersen, Senior Program Manager, REAL ID Program, Department of Homeland Security, Transportation Security Administration, Enrollment Services & Vetting Programs, 6595 Springfield Center Drive, Springfield, VA 20598-6010

Phone: 571 227-2215

Email: george.petersen@tsa.dhs.gov

RIN: 1652-AA78

DHS—TSA

10. • NORMALIZING UNMANNED AIRCRAFT SYSTEMS BEYOND VISUAL LINE OF SIGHT OPERATIONS [1652-AA80]

Priority: Other Significant. Major under 5 U.S.C. 801.

Regulatory Accounting: Deregulatory

Legal Authority: 49 U.S.C. 114, 44901, 44903

Relevant Executive Orders: 14157; 14159; 14161; 14305; 14307; 14165

CFR Citation: 49 CFR 1540; 49 CFR 1544; 49 CFR 1550

Legal Deadline: Final, Statutory, December 7, 2025, Deadline for FAA BVLOS Final Rule under section 930 of Pub. L. 118-63 (May 16, 2024).

Abstract: This final rule is intended to provide a predictable and clear pathway for safe, routine, and scalable UAS operations that include package delivery, agriculture, aerial surveying, civic interest, operations training, demonstration, recreation, and flight testing. This final rule will be issued in conjunction with the FAA's final rule. FAA's final rule provides performance-based regulations enabling the design and operation of unmanned aircraft systems at low altitudes beyond visual line of sight and for third-party services, to include UAS Traffic Management, that support these operations. The FAA Reauthorization Act of 2024 directs the development of this rulemaking. TSA's rule is necessary to support the secure integration of BVLOS UAS operations into the national air space system.

TSA's final rule makes complementary changes to its regulations to require necessary security measures on these operations consistent with its current regulatory structure for civil aviation.

Statement of Need: TSA has proposed revisions to its regulations to ensure that the FAA's regulation of BVLOS UAS operations under part 108 does not inadvertently create a security gap under TSA regulations.

Anticipated Cost and Benefits: TSA is continuing to assess the anticipated costs and benefits of the final rule.

Timetable:

Action	Date	FR Cite
NPRM	08/07/25	90 FR 38212
NPRM Comment Period End	10/06/25
Final Rule	05/00/26

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: Local

URL For More Information: www.regulations.gov

URL For Public Comments: www.regulations.gov

Agency Contact: James Ruger, Chief Economist, Economic Analysis Branch-Coordination & Analysis Division, Department of Homeland Security, Transportation Security Administration, Policy, Plans, and Engagement, 6595 Springfield Center Drive, Springfield, VA 20598-6028

Phone: 571 227-5519

Hans Kessler, Attorney Advisor, Department of Homeland Security, Transportation Security Administration, Regulations and Security Standards, 6595 Springfield Center Drive, Springfied, VA 20598

Phone: 571 227-1086

Email: hans.kessler@tsa.dhs.gov

Craig Mosford, Aviation Sector Manager, Policy, Plans, and ( printed page 52865) Engagement, Department of Homeland Security, Transportation Security Administration, 6595 Springfield Center Drive, Springfield, VA 20598

Phone: 571 227-5245

Email: bvlos@tsa.dhs.gov

Related RIN: Related to 2120-AL82

RIN: 1652-AA80

DHS—U.S. Immigration and Customs Enforcement (USICE)	Final Rule Stage

11. ESTABLISHING A FIXED TIME PERIOD OF ADMISSION AND AN EXTENSION OF STAY PROCEDURE FOR NONIMMIGRANT ACADEMIC STUDENTS, EXCHANGE VISITORS, AND REPRESENTATIVES OF FOREIGN INFORMATION MEDIA [1653-AA95]

Priority: Economically Significant. Major under 5 U.S.C. 801.

Regulatory Accounting: Fully or Partially Exempt

Legal Authority: 8 U.S.C. 1101; 8 U.S.C. 1103; 8 U.S.C. 1182; 8 U.S.C. 1184

CFR Citation: 8 CFR 214; 8 CFR 274a; 8 CFR 248

Legal Deadline: None

Abstract: This rule proposes to eliminate the Duration of Status admission for F, J, and I nonimmigrant categories and replace it with a date-limited authorized period of stay when entering the United States. The fixed date would eliminate confusion over how long foreign students, exchange visitors, and representatives of foreign information media may stay in the United States. It would also improve the Department's efforts to reduce overstay rates and address fraud and national security concerns.

Statement of Need: The failure to provide certain categories of nonimmigrants with specific dates for their authorized periods of stay has contributed to fraud, exploitation, and abuse in the system. These changes will allow DHS to effectively assess whether these nonimmigrants are complying with the conditions of their classifications and U.S. immigration law while also mitigating national security risks.

Anticipated Cost and Benefits: Through this NPRM, the DHS proposed changes would have an annualized cost ranging from $390.3 million to $392.4 million (using 3 and 7 percent discount rates, respectively).

Timetable:

Action	Date	FR Cite
NPRM	08/28/25	90 FR 42070
NPRM Comment Period End	09/29/25
Final Action	03/00/26

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Federal

Agency Contact: Sharon Hageman, Deputy Assistant Director, Department of Homeland Security, U.S. Immigration and Customs Enforcement, 500 12th Street SW, Mail Stop 5006, Washington, DC 20536

Phone: 202 732-6960

Email: ice.regulations@ice.dhs.gov

RIN: 1653-AA95

DHS—Federal Emergency Management Agency (FEMA)	Final Rule Stage

12. REMOVAL OF UPDATES TO FLOODPLAIN MANAGEMENT AND PROTECTION OF WETLANDS REGULATIONS [1660-AB18]

Priority: Other Significant

Regulatory Accounting: Other

Legal Authority: 6 U.S.C. 101 et seq.;42 U.S.C. 4001 et seq.;42 U.S.C. 4321 et seq.;E.O. 11988 of May 24, 1977, 42 FR 26951, 3 CFR, 1977 Comp., p. 117; E.O. 11990 of May 24, 1977, 42 FR 26961, 3 CFR, 1977 Comp., p. 121

Relevant Executive Orders: 14148; 14219; 14267

CFR Citation: 44 CFR part 9

Legal Deadline: None

Abstract: This rule would rescind certain provisions in the July 11, 2024, final rule titled Updates to Floodplain Management and Protection of Wetlands Regulations to Implement the Federal Flood Risk Management Standard. FEMA had issued this rule due to Executive Order 14030, which reinstated the Federal Flood Risk Management Standard (FFRMS). On January 20, 2025, President Trump issued Executive Order 14148, Initial Rescissions of Harmful Executive Orders and Actions. This Executive Order rescinded Executive Order 14030, thereby eliminating the standard. FEMA stopped implementation of the FFRMS on March 25, 2025, consistent with Executive Order 14148. FEMA is now undertaking rulemaking to remove the specific requirements of Executive Order 14030 from its regulations. Removing the standard from Part 9 will streamline FEMA's regulations, streamline program implementation, and reduce burdens on the public.

Statement of Need: In 2024, following Executive Order 14030, FEMA incorporated the Federal Flood Risk Management Standard (FFRMS) into 44 CFR part 9. However, in January 2025, Executive Order 14148 rescinded Executive Order 14030, thereby eliminating the FFRMS. FEMA stopped implementing the FFRMS in March 2025 and plans to update 44 CFR part 9 to remove the FFRMS from FEMA's regulations.

Anticipated Cost and Benefits: DHS is currently considering the specific impacts of this action.

Timetable:

Action	Date	FR Cite
Interim Final Rule	09/00/26

Regulatory Flexibility Analysis Required: No

Government Levels Affected: Federal, Local, State, Tribal

Agency Contact: Portia Ross, Office of Environmental and Historic Preservation, Department of Homeland Security, Federal Emergency Management Agency, 400 C Street SW, Washington, DC 20472

Phone: 202 709-0677

Email: fema-regulations@fema.dhs.gov

RIN: 1660-AB18

DHS—Cybersecurity and Infrastructure Security Agency (CISA)	Final Rule Stage

13. CYBER INCIDENT REPORTING FOR CRITICAL INFRASTRUCTURE ACT (CIRCIA) REPORTING REQUIREMENTS [1670-AA04]

Priority: Other Significant. Major under 5 U.S.C. 801.

Regulatory Accounting: Fully or Partially Exempt

Legal Authority: 6 U.S.C. 681 et seq.

CFR Citation: 6 CFR 226

Legal Deadline: NPRM, Statutory, March 15, 2024, Notice of Proposed Rulemaking. Final, Statutory, October 4, 2025, Final Rule.

Abstract: The Cybersecurity and Infrastructure Security Agency (CISA) will finalize regulations to implement certain aspects of the Cyber Incident Reporting for Critical Infrastructure Act of 2022 (CIRCIA). Specifically, CIRCIA directs CISA to develop and implement regulations requiring covered entities to submit reports to CISA regarding covered cyber incidents and ransom payments. CISA published the NPRM on April 4, 2024. CISA received significant public comments on the proposed rule, many of which emphasized the need to reduce the scope and burden of the proposed reporting requirements, improve harmonization of CIRCIA with other federal cyber incident reporting ( printed page 52866) requirements, and clarify terms. CISA is considering the public comments and examining options for the rulemaking. Additional information about this rulemaking is available at www.cisa.gov/circia.

Statement of Need: Congress directed CISA to promulgate regulations requiring covered entities to report covered cyber incidents and ransom payments to CISA.

Summary of Legal Basis: This regulation is statutorily mandated by 6 U.S.C. 681 et seq.

Anticipated Cost and Benefits: CISA is continuing to assess the anticipated costs and benefits of the final rule.

Timetable:

Action	Date	FR Cite
NPRM	04/04/24	89 FR 23644
NPRM Comment Period Extended	05/06/24	89 FR 37141
NPRM Correction	06/03/24	89 FR 47471
NPRM Comment Period End	06/03/24
NPRM Comment Period Extended End	07/03/24
Final Rule	05/00/26

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses, Governmental Jurisdictions, Organizations

Government Levels Affected: Local, State, Tribal

URL For More Information: www.regulations.gov

URL For Public Comments:

www.regulations.gov

Agency Contact: Todd Klessman, CIRCIA Rulemaking Team Lead, Department of Homeland Security, Cybersecurity and Infrastructure Security Agency, CISA—WB2 Stop 0612, 4200 Wilson Blvd., Arlington, VA 20598-0612

Phone: 202 964-6869

Email: circia@cisa.dhs.gov

RIN: 1670-AA04

DHS—Customs Revenue Functions (CUSTREV)	Final Rule Stage

14. ELECTRONIC BOND TRANSMISSION [1685-AA24]

Priority: Other Significant. Major status under 5 U.S.C. 801 is undetermined.

Regulatory Accounting: Deregulatory

Legal Authority: 19 U.S.C. 66; 19 U.S.C. 1411(a)(2)(D); 19 U.S.C. 1623; 19 U.S.C. 1624

CFR Citation: 19 CFR part 113

Legal Deadline: None

Abstract: This Notice of Proposed Rulemaking proposes to amend the CBP regulations to require that most bonds be transmitted to CBP electronically via a specialized system by the surety securing the bond, or by the principal on a bond secured by cash in lieu of surety. The proposed amendments eliminate the more onerous and inefficient paper-based bond application and approval processes. Moving forward, the proposed amendments would implement the successful National Customs Automation Program test for electronic bonds (“eBonds”).

Statement of Need: The proposed rule is needed to modernize existing regulations and reduce burdens on the public.

Anticipated Cost and Benefits: DHS is currently considering the specific impacts of the provisions.

Timetable:

Action	Date	FR Cite
NPRM	02/13/26	91 FR 6986
NPRM Comment Period End	04/14/26
Final Rule	To Be	Determined

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: None

Agency Contact: Kara Welty, Chief, Revenue Protection Branch, Revenue Division, Department of Homeland Security, Customs Revenue Functions, 8899 E 56th Street, Indianapolis, IN 46249

Phone: 202 875-3284

Email: kara.n.welty@cbp.dhs.gov

Sharolyn McCann, Director, Commercial Operations, Revenue & Entry Division, Department of Homeland Security, Customs Revenue Functions, 1331 Pennsylvania Avenue NW, Washington, DC 20004

Phone: 202 384-8935

Email: sharolyn.j.mccann@cbp.dhs.gov

Related RIN: Previously reported as 1515-AE49

RIN: 1685-AA24

BILLING CODE 9110-9B-P

DHS—U.S. Citizenship and Immigration Services (USCIS)	Proposed Rule Stage

71. • IMPROVING THE PROCESS OF CERTIFICATION OF FORM N-648, MEDICAL CERTIFICATION FOR DISABILITY EXCEPTIONS

Priority: Other Significant. Major status under 5 U.S.C. 801 is undetermined.

Regulatory Accounting: Fully or Partially Exempt

Unfunded Mandates: Undetermined

Legal Authority: 8 U.S.C. 1103; 8 U.S.C. 1423; 8 U.S.C. 1443

Relevant Executive Orders: 14161

CFR Citation: 8 CFR part 312; 8 CFR 106.2; 8 CFR part 336

Legal Deadline: None

Anticipated Cost and Benefits: DHS is currently considering the specific impacts of the proposed provisions.

Timetable:

Action	Date	FR Cite
NPRM	04/00/27

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Federalism: Undetermined

Phone: 240 721-3000

RIN: 1615-AD07

DHS—USCIS

( printed page 52867)

72. • NATURALIZATION APPLICATION FEE ADJUSTMENTS

Priority: Other Significant. Major status under 5 U.S.C. 801 is undetermined.

Regulatory Accounting: Fully or Partially Exempt

Unfunded Mandates: Undetermined

Legal Authority: 8 U.S.C. 1356(m), (n)

CFR Citation: 8 CFR 106.2; 8 CFR 106.3

Legal Deadline: None

Alternatives: DHS is currently considering the specific impacts of the proposed provisions.

Anticipated Cost and Benefits: DHS is currently considering the specific impacts of the proposed provisions.

Timetable:

Action	Date	FR Cite
NPRM	06/23/26	91 FR 37500
NPRM Comment Period End	08/24/26

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Federalism: Undetermined

Phone: 240 721-3000

RIN: 1615-AD08

DHS—USCIS

73. • PROTECTING THE INTEGRITY OF NATURALIZATION THROUGH ENHANCED EDUCATIONAL STANDARDS

Priority: Other Significant. Major status under 5 U.S.C. 801 is undetermined.

Regulatory Accounting: Fully or Partially Exempt

Unfunded Mandates: Undetermined

Legal Authority: 8 U.S.C. 1103; 8 U.S.C. 1423; 8 U.S.C. 1443

Relevant Executive Orders: 14161

CFR Citation: 8 CFR part 312, 8 CRF part 316, 8 CFR part 3

Legal Deadline: None

Anticipated Cost and Benefits: DHS is currently considering the specific impacts of the proposed provisions.

Timetable:

Action	Date	FR Cite
NPRM	12/00/26

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Federalism: Undetermined

Phone: 240 721-3000

RIN: 1615-AD13

DHS—USCIS

74. • SPONSOR REIMBURSEMENT AND DEEMING 8 CFR 213A

Priority: Other Significant. Major status under 5 U.S.C. 801 is undetermined.

Regulatory Accounting: Fully or Partially Exempt

Unfunded Mandates: Undetermined

Legal Authority: INA 213A (8 U.S.C. 1183a); 8 U.S.C. 1631; 8 U.S.C. 1632

CFR Citation: 8 CFR 213a

Legal Deadline: None

Abstract: DHS proposes to amend its regulations relating to the mechanisms by which the Federal government, as well as the States and state agencies, hold the sponsors of aliens to their commitments to financially support those aliens. The project will include amendments relating to requests for reimbursement and actions to compel reimbursement. DHS will also amend its regulations to clarify the responsibilities of States and state agencies to attribute a sponsor's income and resources to an alien when determining the eligibility and the amount of benefits of an alien for means-tested public benefits programs.

Anticipated Cost and Benefits: DHS is currently considering the specific impacts of the proposed provisions.

Timetable:

Action	Date	FR Cite
NPRM	06/00/27

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Federalism: Undetermined

Agency Contact: Mark Phillips, Residence and Naturalization Division Chief, Department of Homeland Security, U.S. Citizenship and ( printed page 52868) Immigration Services, Office of Policy and Strategy, 5900 Capital Gateway Drive, Suite 4S190, Camp Springs, MD 20588-0009

Phone: 240 721-3000

RIN: 1615-AD15

DHS—U.S. Coast Guard (USCG)	Proposed Rule Stage

75. CLARIFICATION OF CERTAIN MARINER TRAINING REQUIREMENTS

Priority: Other Significant

Regulatory Accounting: Deregulatory

Legal Authority: 46 U.S.C. 7101(c)

CFR Citation: 46 CFR 11.317; 46 CFR 11.321(a); 46 CFR 11.321(b); 46 CFR 12.611(a)(4)

Legal Deadline: None

Abstract: The Coast Guard proposes to remove four merchant mariner credentialing training requirements related to Standards of Training, Certification, and Watchkeeping (STCW) officer and rating endorsements from its regulations in 46 CFR parts 11 and 12. The Coast Guard has determined that these training requirements exceed the minimum training and certification standards required by the STCW. These training requirements are not necessary for the safety of life and property at sea. The rule would propose to remove: leadership and managerial skills training to qualify as master of vessels of less than 500 gross tons (GT) limited to near-coastal waters; demonstration of meeting the standard of competence in leadership and teamworking skills to renew an endorsement of an STCW as an officer in charge of a navigational watch (OICNW) of vessels of less than 500 GT limited to near-coastal waters to be valid on or after January 1, 2017; bridge resource management training to qualify as OICNW on vessels of less than 500 GT limited to near-coastal waters; and computer systems and maintenance training to qualify as electro-technical rating (ETR) on vessels powered by main propulsion machinery of 750 kilowatts (kW)/1,000 horsepower (HP) or more.

Statement of Need: The Coast Guard has determined that five requirements exceed current international certification and training standards of the STCW, causing a misalignment between the training of U.S. mariners and the mariners of other countries. These requirements are not necessary for the safety of life and property at sea.

Anticipated Cost and Benefits: DHS is currently considering the specific impacts of the proposed provisions.

Timetable:

Action	Date	FR Cite
NPRM	11/00/26

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: None

Agency Contact: Megan Johns Henry, Marine Transportation Specialist, Department of Homeland Security, U.S. Coast Guard, Office of Merchant Mariner Credentialing (CG-MMC-1), 2703 Martin Luther King Jr. Avenue SE, STOP 7509, Washington, DC 20593-7509

Phone: 571 610-3303

Email: megan.c.johns@uscg.mil

RIN: 1625-AC48

DHS—USCG

76. SHIPPING SAFETY FAIRWAYS ALONG THE ATLANTIC COAST

Priority: Other Significant

Regulatory Accounting: Deregulatory

Legal Authority: 46 U.S.C. 70001; 46 U.S.C. 70003; 46 U.S.C. 70034

Relevant Executive Orders: 14269

CFR Citation: 33 CFR 166; 33 CFR 167

Legal Deadline: None

Timetable:

Action	Date	FR Cite
ANPRM	06/19/20	85 FR 37034
ANPRM Comment Period End	08/18/20
NPRM	01/19/24	89 FR 3587
Notification of Public Meeting; Extension of Comment Period	03/25/24	89 FR 20582
NPRM Comment Period Extended End	05/17/24
NPRM Comment Period Reopened	05/05/26
NPRM Reopened Comment Period End	06/22/26

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: None

URL For More Information: www.regulations.gov

URL For Public Comments: www.regulations.gov

Phone: 571 608-5384

Email: maureen.r.kallgren2@uscg.mil

RIN: 1625-AC57

DHS—USCG	Final Rule Stage

77. ELECTRONIC CHART AND NAVIGATION EQUIPMENT CARRIAGE REQUIREMENTS

Priority: Economically Significant. Major under 5 U.S.C. 801.

Regulatory Accounting: Deregulatory

Legal Authority: 46 U.S.C. 3105

Relevant Executive Orders: 14269

CFR Citation: 33 CFR 164; 46 CFR 26; 46 CFR 28; 46 CFR 35; 46 CFR 78; 46 CFR 97; 46 CFR 109; 46 CFR 121; 46 CFR 130; 46 CFR 140; 46 CFR 167; 46 CFR 169; 46 CFR 184; 46 CFR 196

Legal Deadline: None

Abstract: This rulemaking would modify the chart, publications, and navigational equipment requirements in titles 33 and 46 of the Code of Federal Regulations (CFR) for all commercial ( printed page 52869) U.S.-flagged vessels and foreign-flagged vessels operating in the waters of the United States.

Statement of Need: This rulemaking is needed to reduce the burden on vessel owners and operators, eliminating unnecessary compliance requirements and streamlining Coast Guard regulations.

Anticipated Cost and Benefits: DHS is currently considering the specific impacts of the proposed provisions.

Timetable:

Action	Date	FR Cite
ANPRM	03/28/22	87 FR 17241
ANPRM Comment Period End	06/27/22
Final Rule with Comment	12/00/26

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Additional Information: Docket number USCG-2021-0291

URL For More Information: www.regulations.gov

URL For Public Comments: www.regulations.gov

Agency Contact: Brian Mottel, Marine Transportation Specialist, Department of Homeland Security, U.S. Coast Guard, Office of Navigation Systems (CG-NAV), 2703 Martin Luther King Jr. Avenue SE, STOP 7509, Washington, DC 20593-1526

Phone: 206 815-4657

Email: david.b.mottel2@uscg.mil

RIN: 1625-AC74

DHS—U.S. Customs and Border Protection (USCBP)	Final Rule Stage

78. ADVANCE PASSENGER INFORMATION SYSTEM: ELECTRONIC VALIDATION OF TRAVEL DOCUMENTS

Priority: Other Significant

Regulatory Accounting: Deregulatory

Legal Authority: 49 U.S.C. 44909; 8 U.S.C. 1221; 19 U.S.C. 1431

CFR Citation: 19 CFR 122

Legal Deadline: None

Statement of Need: This Rule is needed to increase the safety of the traveling public, the air carrier industry, and the United States.

Timetable:

Action	Date	FR Cite
NPRM	02/02/23	88 FR 7016
NPRM Comment Period End	04/03/23
Final Action	09/00/26

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

URL For More Information: www.regulations.gov

URL For Public Comments: www.regulations.gov

Agency Contact: Robert Neumann, Program Manager, Office of Field Operations, Department of Homeland Security, U.S. Customs and Border Protection, 1300 Pennsylvania Avenue NW, Washington, DC 20229

Phone: 202 412-2788

Email: robert.m.neumann@cbp.dhs.gov

RIN: 1651-AB43

DHS—USCBP

79. AUTOMATED COMMERCIAL ENVIRONMENT (ACE) ELECTRONIC EXPORT MANIFEST FOR RAIL CARGO

Priority: Other Significant

Regulatory Accounting: Deregulatory

Legal Authority: 19 U.S.C. 1415

CFR Citation: 123.93

Legal Deadline: None

Abstract: This rulemaking proposes to create a new regulation requiring the submission of export manifest data electronically to U.S. Customs and Border Protection (CBP) in the Automated Commercial Environment (ACE) for cargo transported by rail pursuant to section 343(a), of the Trade Act of 2002, as amended (19 U.S.C. 1415), for any train departing the United States. The proposed regulation would mandate the electronic transmission of rail export manifest information, identify the parties eligible to transmit information, describe the time frames prior to departure of the train in which the information is due, and identify an initial filing that must occur 24 hours prior to departure from the port of export while requiring that remaining data be transmitted at least two hours prior to such departure. This rule is deregulatory and will result in both time savings and cost savings for carriers, transmitters, and CBP.

Statement of Need: This Rule is needed to address important cargo security concerns while providing efficiencies to the trade.

Timetable:

Action	Date	FR Cite
NPRM	01/13/25	90 FR 2874
NPRM Comment Period End	03/14/25
Final Rule	07/00/26

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

International Impacts: This regulatory action will be likely to have international trade and investment effects, or otherwise be of international interest.

URL For More Information: www.regulations.gov

URL For Public Comments: www.regulations.gov

Phone: 202 344-3277

Email: cbpexportmanifest@cpb.dhs.gov

RIN: 1651-AB52 ( printed page 52870)

DHS—Transportation Security Administration (TSA)	Final Rule Stage

80. VETTING OF CERTAIN SURFACE TRANSPORTATION EMPLOYEES

Priority: Other Significant

Regulatory Accounting: Regulatory

Legal Authority: 49 U.S.C. 114; Pub. L. 108-90, sec. 520; Pub. L. 110-53, secs. 1411, 1414, 1512, 1520, 1522, and 1531

Relevant Executive Orders: 14157; 14159; 14161; 14165

CFR Citation: 49 CFR 1500 ; 49 CFR 1530; 49 CFR 1570; 49 CFR 1572; 49 CFR 1580; 49 CFR 1582; 49 CFR 1584; . . .

Timetable:

Action	Date	FR Cite
NPRM	05/23/23	88 FR 33472
NPRM Comment Period End	08/21/23
NPRM Extension of Comment Period	08/22/23	88 FR 57044
NPRM Extension Comment Period End	10/01/23
Final Rule	11/00/26

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses, Governmental Jurisdictions, Organizations

Government Levels Affected: Local

URL For More Information: www.regulations.gov

URL For Public Comments: www.regulations.gov

Phone: 571 227-3740

Email: ashlee.marks@tsa.dhs.gov

James Ruger, Chief Economist, Economic Analysis Branch—Coordination & Analysis Division, Department of Homeland Security, Transportation Security Administration, Policy, Plans, and Engagement, 6595 Springfield Center Drive, Springfield, VA 20598-6028

Phone: 571 227-5519

Phone: 571 227-3653

Email: christine.beyer@tsa.dhs.gov

Related RIN: Related to 1652-AA55, Related to 1652-AA56

RIN: 1652-AA69

DHS—TSA

81. MINIMUM STANDARDS FOR DRIVER'S LICENSES AND IDENTIFICATION CARDS ACCEPTABLE BY FEDERAL AGENCIES FOR OFFICIAL PURPOSES; PROCEDURES FOR REMOTE APPLICATION AND ISSUANCE

Priority: Other Significant. Major status under 5 U.S.C. 801 is undetermined.

Regulatory Accounting: Deregulatory

Legal Authority: 49 U.S.C. 30301 note; 6 U.S.C. 111, 112; 49 U.S.C. 114

Relevant Executive Orders: 14159; 14161; 14165

CFR Citation: 6 CFR 37

Legal Deadline: None

Statement of Need: This rulemaking is necessary to implement authority under the REAL ID Modernization Act, Section 1001 of Title X, Consolidated Appropriations Act, 2021, Pub. L .116-260 (Dec. 27, 2020), which authorized electronic submission of information and remote issuance of REAL ID cards under regulations prescribed by the Secretary.

Timetable: ( printed page 52871)

Action	Date	FR Cite
Final Action	11/00/26

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: Federal, State

URL For More Information: www.regulations.gov

URL For Public Comments: www.regulations.gov

Phone: 571 227-4812

Email: anurag.maheshwary@tsa.dhs.gov

Phone: 571 227-5519

Phone: 571 227-2215

Email: george.petersen@tsa.dhs.gov

RIN: 1652-AA78

DHS—TSA

82. • NORMALIZING UNMANNED AIRCRAFT SYSTEMS BEYOND VISUAL LINE OF SIGHT OPERATIONS

Priority: Other Significant. Major under 5 U.S.C. 801.

Regulatory Accounting: Deregulatory

Legal Authority: 49 U.S.C. 114, 44901, 44903

Relevant Executive Orders: 14157; 14159; 14161; 14305; 14307; 14165

CFR Citation: 49 CFR 1540; 49 CFR 1544; 49 CFR 1550

Legal Deadline: Final, Statutory, December 7, 2025, Deadline for FAA BVLOS Final Rule under section 930 of Pub. L. 118-63 (May 16, 2024).

TSA's final rule makes complementary changes to its regulations to require necessary security measures on these operations consistent with its current regulatory structure for civil aviation.

Anticipated Cost and Benefits: TSA is continuing to assess the anticipated costs and benefits of the final rule.

Timetable:

Action	Date	FR Cite
NPRM	08/07/25	90 FR 38212
NPRM Comment Period End	10/06/25
Final Rule	07/00/26

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: Local

URL For More Information: www.regulations.gov

URL For Public Comments: www.regulations.gov

Agency Contact: James Ruger, Chief Economist, Economic Analysis Branch—Coordination & Analysis Division, Department of Homeland Security, Transportation Security Administration, Policy, Plans, and Engagement, 6595 Springfield Center Drive, Springfield, VA 20598-6028

Phone: 571 227-5519

Hans Kessler, Attorney Advisor, Department of Homeland Security, Transportation Security Administration, Regulations and Security Standards, 6595 Springfield Center Drive, Springfied, VA 20598

Phone: 571 227-1086

Email: hans.kessler@tsa.dhs.gov

Craig Mosford, Aviation Sector Manager, Policy, Plans, and Engagement, Department of Homeland Security, Transportation Security Administration, 6595 Springfield Center Drive, Springfield, VA 20598

Phone: 571 227-5245

Email: bvlos@tsa.dhs.gov

Related RIN: Related to 2120-AL82

RIN: 1652-AA80

DHS—U.S. Immigration and Customs Enforcement (USICE)	Final Rule Stage

83. ESTABLISHING A FIXED TIME PERIOD OF ADMISSION AND AN EXTENSION OF STAY PROCEDURE FOR NONIMMIGRANT ACADEMIC STUDENTS, EXCHANGE VISITORS, AND REPRESENTATIVES OF FOREIGN INFORMATION MEDIA

Priority: Economically Significant. Major under 5 U.S.C. 801.

Regulatory Accounting: Fully or Partially Exempt

Legal Authority: 8 U.S.C. 1101; 8 U.S.C. 1103; 8 U.S.C. 1182; 8 U.S.C. 1184

CFR Citation: 8 CFR 214; 8 CFR 274a; 8 CFR 248

Legal Deadline: None

Timetable:

Action	Date	FR Cite
NPRM	08/28/25	90 FR 42070
NPRM Comment Period End	09/29/25
Final Action	07/00/26

( printed page 52872)

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Federal

Agency Contact: Sharon Hageman, Deputy Assistant Director, Department of Homeland Security, U.S. Immigration and Customs Enforcement, 500 12th Street SW, Mail Stop 5006, Washington, DC 20536

Phone: 202 732-6960

Email: ice.regulations@ice.dhs.gov

RIN: 1653-AA95

DHS—Federal Emergency Management Agency (FEMA)	Final Rule Stage

84. REMOVAL OF UPDATES TO FLOODPLAIN MANAGEMENT AND PROTECTION OF WETLANDS REGULATIONS

Priority: Other Significant

Regulatory Accounting: Other

Relevant Executive Orders: 14148; 14219; 14267

CFR Citation: 44 CFR part 9

Legal Deadline: None

Anticipated Cost and Benefits: DHS is currently considering the specific impacts of this action.

Timetable:

Action	Date	FR Cite
Interim Final Rule	09/00/26

Regulatory Flexibility Analysis Required: No

Government Levels Affected: Federal, Local, State, Tribal

Agency Contact: Portia Ross, Office of Environmental and Historic Preservation, Department of Homeland Security, Federal Emergency Management Agency, 400 C Street SW, Washington, DC 20472

Phone: 202 709-0677

Email: fema-regulations@fema.dhs.gov

RIN: 1660-AB18

DHS—Cybersecurity and Infrastructure Security Agency (CISA)	Final Rule Stage

85. CYBER INCIDENT REPORTING FOR CRITICAL INFRASTRUCTURE ACT (CIRCIA) REPORTING REQUIREMENTS

Priority: Other Significant. Major under 5 U.S.C. 801.

Regulatory Accounting: Fully or Partially Exempt

Legal Authority: 6 U.S.C. 681 et seq.

CFR Citation: 6 CFR 226

Legal Deadline: NPRM, Statutory, March 15, 2024, Notice of Proposed Rulemaking.

Final, Statutory, October 4, 2025, Final Rule.

Abstract: The Cybersecurity and Infrastructure Security Agency (CISA) will finalize regulations to implement certain aspects of the Cyber Incident Reporting for Critical Infrastructure Act of 2022 (CIRCIA). Specifically, CIRCIA directs CISA to develop and implement regulations requiring covered entities to submit reports to CISA regarding covered cyber incidents and ransom payments. CISA published the NPRM on April 4, 2024. CISA received significant public comments on the proposed rule, many of which emphasized the need to reduce the scope and burden of the proposed reporting requirements, improve harmonization of CIRCIA with other federal cyber incident reporting requirements, and clarify terms. CISA is considering the public comments and examining options for the rulemaking. Additional information about this rulemaking is available at www.cisa.gov/circia.

Statement of Need: Congress directed CISA to promulgate regulations requiring covered entities to report covered cyber incidents and ransom payments to CISA.

Summary of Legal Basis: This regulation is statutorily mandated by 6 U.S.C. 681 et seq.

Anticipated Cost and Benefits: CISA is continuing to assess the anticipated costs and benefits of the final rule.

Timetable:

Action	Date	FR Cite
NPRM	04/04/24	89 FR 23644
NPRM Comment Period Extended	05/06/24	89 FR 37141
NPRM Correction	06/03/24	89 FR 47471
NPRM Comment Period End	06/03/24
NPRM Comment Period Extended End	07/03/24
Final Rule	09/00/26

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses, Governmental Jurisdictions, Organizations

Government Levels Affected: Local, State, Tribal

URL For More Information: www.regulations.gov

URL For Public Comments: www.regulations.gov

Phone: 202 964-6869

Email: circia@cisa.dhs.gov

RIN: 1670-AA04

DHS—Customs Revenue Functions (CUSTREV)	Final Rule Stage

86. ELECTRONIC BOND TRANSMISSION

Priority: Other Significant. Major status under 5 U.S.C. 801 is undetermined.

Regulatory Accounting: Deregulatory

Legal Authority: 19 U.S.C. 66; 19 U.S.C. 1411(a)(2)(D); 19 U.S.C. 1623; 19 U.S.C. 1624

CFR Citation: 19 CFR part 113

Legal Deadline: None

Abstract: This rulemaking amends the CBP regulations to require that most bonds be transmitted to CBP electronically via a specialized system ( printed page 52873) by the surety securing the bond, or by the principal on a bond secured by cash in lieu of surety. The amendments eliminate the more onerous and inefficient paper-based bond application and approval processes. Moving forward, the amendments would implement the successful National Customs Automation Program test for electronic bonds (“eBonds”).

Statement of Need: The rule is needed to modernize existing regulations and reduce burdens on the public.

Anticipated Cost and Benefits: DHS is currently considering the specific impacts of the provisions.

Timetable:

Action	Date	FR Cite
NPRM	02/13/26	91 FR 6986
NPRM Comment Period End	04/14/26
Final Rule	To Be Determined

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: None

Agency Contact: Kara Welty, Chief, Revenue Protection Branch, Revenue Division, Department of Homeland Security, Customs Revenue Functions, 8899 E 56th Street, Indianapolis, IN 46249

Phone: 202 875-3284

Email: kara.n.welty@cbp.dhs.gov

Sharolyn McCann, Director, Commercial Operations, Revenue & Entry Division, Department of Homeland Security, Customs Revenue Functions, 1331 Pennsylvania Avenue NW, Washington, DC 20004

Phone: 202 384-8935

Email: sharolyn.j.mccann@cbp.dhs.gov

Related RIN: Previously reported as 1515-AE49

RIN: 1685-AA24

BILLING CODE 9110-9B-P

DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT STATEMENT OF REGULATORY PRIORITIES FOR FISCAL YEAR 2026

Introduction

The Regulatory Plan for the Department of Housing and Urban Development (HUD) for Fiscal Year (FY) 2026 highlights two significant regulations that HUD seeks to publish during the upcoming fiscal year. HUD is committed to promoting healthy, safe, and affordable housing

Under the leadership of Secretary Scott Turner, HUD is dedicated to setting forth initiatives to reduce burdens on the public, improve program integrity, and provide clearer information for program participants across all HUD programs. HUD is intending to finalize 22 regulations to reduce burden, and propose another 15.

The rules highlighted in HUD's regulatory plan for FY 2026 reflect HUD's efforts to continue its work in building strong and sustainable communities and addressing the housing needs of all Americans.

Updating the Definition of Chassis To Promote Production of Manufactured Homes

HUD's Manufactured Home Construction and Safety Standards (MHCSS) regulations are currently interpreted to require that every transportable section of a manufactured home be built and transported on a permanent chassis. This proposed rule would revise HUD's regulations to clarify that this requirement applies only to the lowest floor of the manufactured home. This proposed rule would amend the definition of “manufactured home” in the MHCSS, Model Manufactured Home Installation Standards (MMHIS), and Manufactured Home Installation Program (MHIP) to provide that a transportable section of a manufactured home serving as part of an upper floor of a manufactured home would not need to be transported or built on a permanent chassis.

Aggregate Costs and Benefits

Executive Order 12866, as amended, requires the agency to provide its best estimate of the combined aggregate costs and benefits of all regulations included in the agency's Regulatory Plan that will be pursued in fiscal year 2026. HUD expects that the proposed rule would reduce the costs associated with vertical density for manufactured homes, leading to economic gains from lower costs for two-story manufactured homes and growth in the manufactured housing market.

Statement of Need

The permanent chassis requirement adds thousands of dollars to the cost of a multistory manufactured home for producers and consumers and creates engineering and architectural challenges that complicate the design and production of multistory manufactured homes. Consequently, the permanent chassis requirement for every transportable section of a multistory manufactured home hinders HUD's execution on the Act's purposes of protecting the affordability of manufactured housing, facilitating the availability of affordable manufactured homes, and encouraging innovative and cost-effective construction techniques. Multistory manufactured homes could be built more cost-effectively and in a more innovative fashion if the permanent chassis requirement did not apply to upper floors.

Alternatives

HUD considered whether retaining this requirement, in one form or another, might serve an important purpose. Ultimately, HUD determined that the requirement provides no practical, safety, aesthetic, or design benefit for upper floors of multistory manufactured homes. Therefore, no alternative short of eliminating the requirement would meet HUD's goals.

Risks

This rule imposes no risks or additional costs on HUD.

Housing and Community Development Act of 1980: Verification of Eligible Status

Section 214 of the Housing and Community Development Act of 1980, as amended (“Section 214”), prohibits the Secretary of HUD from making financial assistance available to persons other than United States citizens or certain categories of eligible aliens in HUD's public and specified assisted housing programs. This proposed rule would revise HUD's Section 214 implementing regulations to require the verification of U.S. citizenship or the eligible immigration status of all applicants and recipients of assistance under a covered program regardless of age. The proposed rule would also make prorated assistance a temporary condition pending verification of eligible status of family members, where permitted by statute, as opposed to under HUD's current regulations where prorated assistance could continue indefinitely.

Aggregate Costs and Benefits

Consistent with the current Administration's regulatory reform efforts, these proposed regulatory amendments are consistent with the principles of Executive Order 13828 and 14218 and the current Administration's regulatory reform efforts. The policy changes will bring HUD's regulations into greater alignment with the requirements of Section 214 and make the administrative process for verification more uniform for citizens and eligible noncitizens, as well as ensure that only U.S. citizens or nationals and eligible noncitizens under Section 214 and other relevant legal authorities have access to HUD financial assistance. ( printed page 52874)

The proposed rule would impose administrative costs on responsible entities and HUD. Most of the costs of the rule would be upfront costs of adjustment, borne by the households adversely affected.

Statement of Need

The proposed rule would ensure better implementation to statutory authorities and align with President Trump's Executive Order to ensure that federal public benefits do not go to unqualified aliens.

Alternatives

In developing this proposed rule, HUD considered alternatives. Alternatives such as grandfathering in existing mixed families or continuing to provide housing assistance to specific subsets of mixed families would decrease administrative and transition costs. However, these alternatives would lead to decreased compliance with Section 214 and this Administration's immigration priorities.

Risks

Verification costs for tenants and applicants may increase the burden of complying with this rule. However, HUD believes based on research and data that methods of verification offset this burden and that verification costs are a necessary cost to ensure compliance with the law.

HUD—Office of the Secretary (HUDSEC)	Final Rule Stage

87. HOUSING AND COMMUNITY DEVELOPMENT ACT OF 1980: VERIFICATION OF ELIGIBLE STATUS (FR-6524)

Priority: Other Significant

Regulatory Accounting: Fully or Partially Exempt

Legal Authority: 42 U.S.C. 1436a; 42 U.S.C. 3535(d)

Relevant Executive Orders: 14218

CFR Citation: 24 CFR part 5, subpart E

Legal Deadline: None

Abstract: Section 214 of the Housing and Community Development Act of 1980, as amended (Section 214) prohibits the Secretary of HUD from making financial assistance available to persons other than United States citizens, nationals, or certain categories of eligible noncitizens in HUD's public and specified assisted housing programs. This proposed rule would require the verification of U.S. citizenship or eligible immigration status of recipients of assistance under a covered program and make prorated assistance a temporary condition pending verification of eligible status. The proposed rule also proposes technical changes to remove outdated acronyms and terminology.

Statement of Need: The proposed rule would ensure better implementation to statutory authorities and align with President Trump's Executive Order to ensure that federal public benefits do not go to unqualified aliens.

Summary of Legal Basis: This falls within HUD's authority to issue regulations under section 7(d) of the Department of Housing and Urban Development Act (42 U.S.C. 3535(d)).

Alternatives: In developing this proposed rule, HUD considered alternatives. Alternatives such as grandfathering in existing mixed families or continuing to provide housing assistance to specific subsets of mixed families would decrease administrative and transition costs. However, these alternatives would lead to decreased compliance with Section 214 and this Administration's immigration priorities.

Anticipated Cost and Benefits: Consistent with the current Administration's regulatory reform efforts, these proposed regulatory amendments are consistent with the principles of Executive Order 13828 and 14218 and the current Administration's regulatory reform efforts. The policy changes will bring HUD's regulations into greater alignment with the requirements of Section 214 and make the administrative process for verification more uniform for citizens and eligible noncitizens, as well as ensure that only U.S. citizens or nationals and eligible noncitizens under Section 214 and other relevant legal authorities have access to HUD financial assistance.

The proposed rule would impose administrative costs on responsible entities and HUD. Most of the costs of the rule would be upfront costs of adjustment, borne by the households adversely affected.

Risks: Verification costs for tenants and applicants may increase the burden of complying with this rule. However, HUD believes based on research and data that methods of verification offset this burden and that verification costs are a necessary cost to ensure compliance with the law.

Timetable:

Action	Date	FR Cite
NPRM	02/20/26	91 FR 8151
NPRM Comment Period End	04/21/26
Final Rule	11/00/26

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: Local, State

Agency Contact: Todd Thomas, Acting Deputy Assistant Secretary, Office of Public Housing and Voucher Programs, Department of Housing and Urban Development, Office of the Secretary, 451 7th Street SW, Washington, DC 20410

Phone: 202 402-4542

Robert Iber, Senior Advisor, Office of Multifamily Housing Programs, Department of Housing and Urban Development, Office of the Secretary, 451 7th Street SW, Room 6106, Washington, DC 20410

Phone: 202 708-3055

RIN: 2501-AE16

HUD—Office of Housing (OH)	Proposed Rule Stage

88. REVISING THE DEFINITION OF “MANUFACTURED HOME” TO LOWER HOUSING COSTS

Priority: Other Significant

Regulatory Accounting: Deregulatory

Legal Authority: 42 U.S.C. 5402, 42 U.S.C. 5403, 42 U.S.C. 5404, ; 42 U.S.C. 5424, 42 U.S.C. 3535(d)

CFR Citation: 24 CFR 3280, 3282, 3284, 3285, 3286, and 3288

Legal Deadline: None

Abstract: This proposed rule would amend the definition of manufactured home to provide that only the first floor of a multistory transportable structure must be built on a permanent chassis. Under this proposed rule, the portion of the transportable section serving as the upper floor(s) would not need to be built on or transported on a permanent chassis. The proposed rule would provide that any transportable section of a manufactured home that does not include a permanent chassis must solely be utilized as part of multistory manufactured homes where the transportable section used for the ground floor is built on a permanent chassis. Units produced by this method would remain subject to all other provisions of the Manufactured Home Construction and Safety Standards (24 CFR part 3280) and Procedural and Enforcement Regulations (24 CFR part 3282) in their entirety under the proposed rule.

Statement of Need: The permanent chassis requirement adds thousands of dollars to the cost of a multistory manufactured home for producers and consumers and creates engineering and architectural challenges that complicate the design and production of multistory ( printed page 52875) manufactured homes. Consequently, the permanent chassis requirement for every transportable section of a multistory manufactured home hinders HUD's execution on the Act's purposes of protecting the affordability of manufactured housing, facilitating the availability of affordable manufactured homes, and encouraging innovative and cost-effective construction techniques. Multistory manufactured homes could be built more cost-effectively and in a more innovative fashion if the permanent chassis requirement did not apply to upper floors.

Summary of Legal Basis: This falls within HUD's authority to issue regulations under section 7(d) of the Department of Housing and Urban Development Act (42 U.S.C. 3535(d)).

Alternatives: HUD considered whether retaining this requirement, in one form or another, might serve an important purpose. Ultimately, HUD determined that the requirement provides no practical, safety, aesthetic, or design benefit for upper floors of multistory manufactured homes. Therefore, no alternative short of eliminating the requirement would meet HUD's goals.

Anticipated Cost and Benefits: Executive Order 12866, as amended, requires the agency to provide its best estimate of the combined aggregate costs and benefits of all regulations included in the agency's Regulatory Plan that will be pursued in fiscal year 2026. HUD expects that the proposed rule would reduce the costs associated with vertical density for manufactured homes, leading to economic gains from lower costs for two-story manufactured homes and growth in the manufactured housing market.

Risks: This rule imposes no risks or additional costs on HUD.

Timetable:

Action	Date	FR Cite
NPRM	07/00/26

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Jason McJury, Office of Manufactured Housing Programs, Department of Housing and Urban Development, Office of Housing, 451 7th Street SW, Washington, DC 20410

Phone: 202 251-4232

RIN: 2502-AJ80

BILLING CODE 4210-67-P

DEPARTMENT OF THE INTERIOR REGULATORY PLAN

2026 Unified Agenda

Introduction

The U.S. Department of the Interior (Interior or the Department) manages the Nation's vast public lands and natural resources for the benefit and enjoyment of the American people. This includes managing approximately 500 million surface acres of Federal land or about 20 percent of the Nation's land area, approximately 700 million subsurface acres of Federal mineral estate,^[3] and nearly 3.2 billion acres of submerged lands on the Outer Continental Shelf (OCS).^[4] Through development of our Nation's energy and mineral resources, timber and grazing operations, and abundant recreation opportunities, Interior powers American prosperity. The Department also protects wildlife and ecosystems, manages water resources, and leads Federal wildland fire management and response activities. Interior's work is done collaboratively with States, local communities, federally recognized Indian Tribes, Alaska Natives, the Native Hawaiian Community, and U.S. Territories.

Interior plays a central role in the Trump administration's energy dominance agenda. The development of domestic energy, minerals, and other natural resources on Federal lands advances the Trump administration's agenda and generates billions of dollars in revenue for current and future generations. Interior is unleashing America's natural resources with a focus on affordable and reliable energy and prioritizing productive uses of Federal land, including grazing and timber harvesting.

Interior provides access to some of the best recreation opportunities in the Nation. Hundreds of millions of people visit Interior-managed lands each year in order to engage in camping, hiking, hunting, fishing, and various other forms of outdoor recreation, all of which support local communities and their economies. Interior is committed to increasing access to these opportunities.

Regulatory Reform Overview

The Department is committed to advancing President Trump's deregulation agenda. Federal regulations have imposed massive costs on millions of Americans and constrained our Nation's economy and productive uses of public lands and natural resources. On February 3, 2025, the Secretary of the Interior Doug Burgum issued Secretary's Order (SO) 3421, “Achieving Prosperity through Deregulation,” which implements the January 31, 2025, Executive Order (E.O.) 14192, “Unleashing Prosperity Through Deregulation.” SO 3421 ensures that the Department's Bureaus and Offices are focused on cutting all red tape to promote America's economic prosperity, further national security, and foster the highest possible quality of life for each United States citizen. Shortly thereafter, in SO 3418, “Unleashing American Energy,” Secretary Burgum directed the Department to suspend, rescind, or revise certain rules and guidance documents that may conflict with the goal of unleashing affordable and reliable energy. Interior has been methodically and expeditiously evaluating the rules and guidance documents referenced in SO 3418. As discussed below, Interior has proposed the repeal or modification of many of the rules referenced in SO 3418, including the Biden administration's overly burdensome rules regarding the Department's Endangered Species Act regulations, management of the National Petroleum Reserve in Alaska, and multiple use of public lands in the Conservation and Landscape Health rule. During Fiscal Year (FY) 2025, the Department rescinded dozens of obsolete, unnecessary, or redundant regulations to advance the President's energy dominance agenda. These rescissions accord with the Trump administration's broader commitment to decrease regulatory burdens, streamline agency processes, and promote energy development on public lands.

As part of President Trump's government-wide deregulatory agenda, Interior published a request for information (RFI) inviting the public to identify outdated, overly complex, or burdensome regulations. The effort aims to lower costs and regulatory burdens on the American people. The Department received hundreds of thoughtful comments and is in the process of identifying ideas for implementation.

In FY 2026, Interior will continue its successful efforts to identify and repeal, replace, or modify regulations that are unlawful, unnecessary, ineffective, or impose costs that are not adequately justified by benefits. Interior will also continue to encourage and seek public input on these regulatory reform efforts, including through its RFI, which remains open to the public. In FY 2026, Interior expects to complete ( printed page 52876) deregulatory actions that will provide significant regulatory cost savings.

Regulatory and Deregulatory Priorities

To help the Secretary advance his priorities to promote energy dominance, affordability, and reliability, including by implementing SO 3418 and the One Big Beautiful Bill Act (OBBBA); right-size its implementation of environmental statutes; increase access to recreational opportunities on Federal land, and more. we are highlighting a few key regulatory and deregulatory efforts below.

OBBB Implementation

Following President Trump's signing of the OBBBA, H.R. 1, on July 4, 2025, the Department began implementing statutory directives that will promote U.S. energy production and timber development.

For example:

Applying for Commingling and Allocation Approval Onshore, RIN 1004-AF38.

The Bureau of Land Management's (BLM) proposed rule “Requirements for Site Security and Production Handling; Applying for Commingling and Allocation Approval,” (RIN 1004-AF38), would revise its regulations to make it easier for operators to combine production from multiple leases—a practice known as commingling—in response to Congress' direction in OBBBA section 50101(d)(3) to approve onshore commingling applications. This approach allows oil and gas production from different leases, often under different ownership, using the same well pad, which reduces environmental impacts, lowers operating costs, and increases overall efficiency. If finalized, the updated rule could result in as much as $1.8 billion in industry savings annually.

Offshore Downhole Commingling Regulatory Updates, RIN 1014-AA68.

The Bureau of Safety and Environmental Enforcement (BSEE) published the final rule “Offshore Downhole Commingling Regulatory Updates.” See 90 FR 38935, August 13, 2025. This rule revises the downhole commingling regulations on the OCS to ensure consistency with the OBBB when BSEE reviews a request for downhole commingling. This rule clarifies that the Department should approve requests for commingling with only limited exceptions.

Offshore Distribution Cap Changes, RIN 1012-AA41.

The Office of Natural Resources Revenue (ONRR) published the direct final rule “Offshore Distribution Cap Changes.” See 90 FR 38938, August 13, 2025. In this rule, ONRR amended its regulations at 30 CFR 1219.512 to raise the cap on the distribution of OCS revenues from $500 million to $650 million for FY 2025.

Right-Sizing Implementation of Environmental Statutes

The Department has made massive strides towards reforming its implementation of the National Environmental Policy Act (NEPA) and the Endangered Species Act (ESA).

In June 2025, Secretary Burgum, in coordination with President Trump, announced reforms to modernize the Department's NEPA regulations and prevent them from being weaponized to delay American innovation and energy infrastructure construction. These modifications implement direction from all three branches of government (President Trump in E.O. 14154 “Unleashing American Energy;” the U.S. Congress in its BUILDER Act amendments as part of the 2023 Fiscal Responsibility Act; and the U.S. Supreme Court in its recent landmark decision in Seven County Infrastructure Coalition v. Eagle County).

In response to SO 3418 and other directives, the Department recently proposed new ESA rules that would better align the Department's regulations with the text and intent of the ESA and would reduce burdens on project proponents. This includes the following:

Listing Endangered and Threatened Species and Designating Critical Habitat, RIN 1018-BI73.

The U.S. Fish and Wildlife Service (FWS) published a proposed rule on November 21, 2025, proposing to revise portions of its regulations that implement section 4 of the ESA. This is a joint proposed rule with National Marine Fisheries Service (NMFS). The proposed revisions concern the procedures and criteria used for listing, reclassifying, and delisting species on the Lists of Endangered and Threatened Wildlife and Plants and designating critical habitat, clarifying, among other things, that the Department can only designate unoccupied habitat if occupied habitat isn't enough for the preservation of the species.

Regulations Pertaining to Endangered and Threatened Wildlife and Plants, RIN 1018-BI74.

FWS published a proposed rule on November 21, 2025, proposing to revise its regulations concerning protection of threatened species under the ESA. FWS proposes to remove the “blanket rule” option for protecting newly listed threatened species pursuant to section 4(d) of the ESA, right-sizing protections for threatened species and decreasing permitting burdens in line with the best reading of the ESA.

Interagency Cooperation Regulations, RIN 1018-BI75.

FWS published a proposed rule on November 21, 2025, proposing to revise portions of its regulations that implement section 7 of the ESA. This is a joint proposed rule with NMFS. The proposed revisions to the interagency cooperation implementing regulations confirm FWS' and NMFS' longstanding application of statutory requirements for interagency cooperation and aim to facilitate quicker consultations.

Regulations for Designating Critical Habitat, RIN 1018-BI76.

FWS published a proposed rule on November 21, 2025, proposing to amend portions of its regulations that implement section 4 of the ESA. Specifically, FWS proposes to revise regulations related to ESA section 4(b)(2), which requires consideration of the economic, national security, and any other relevant impacts of designating any particular area as critical habitat. Section 4(b)(2)(d) authorizes the exclusion of areas from critical habitat if the benefits of excluding the area outweigh the benefits of designating it as critical habitat. Here, the Department proposes text that would permit additional industry and landowner participation when excluding lands from the designation of critical habitat.

Definition of “Harm” Under the Endangered Species Act, RIN 1018-BI38.

FWS published a proposed rule on April 17, 2025, to rescind the regulatory definition of “harm” in its ESA regulations. This is a joint proposed rule with NMFS. The existing regulatory definition of “harm,” which includes habitat modification, runs contrary to the best meaning of the statutory term “take.” FWS undertakes this change to adhere to the single, best meaning of the ESA.

Achieving U.S. Energy Dominance while Promoting Affordable and Reliable Energy.

As discussed above, the Department is implementing the President's and Secretary's energy dominance agenda as outlined in several Executive and Secretary's orders.^[5] These orders direct the removal of impediments imposed on ( printed page 52877) the development and use of our Nation's abundant energy and natural resources by obsolete, unnecessary, and burdensome regulations. In FY 2026, the Department will continue to focus on deregulating with an eye towards promoting affordable and reliable energy. This includes potential changes to regulations involving energy and critical minerals identification, permitting, leasing, development, production, transportation, refining, distribution, exporting, and generation capacity onshore and offshore.

The Department will pursue finalizing the following rules to advance the administration's energy dominance agenda:

Rescission of Conservation and Landscape Health Rule, RIN 1004-AF03.

On September 11, 2025, BLM proposed rescinding the Biden-era, Conservation and Landscape Health rule. In its proposed rule, BLM explained that the Conservation and Landscape Health rule is inconsistent with the Federal Land Management and Policy Act's (FLPMA) multiple-use mandate and that rescission would provide the framework for future land management plans to better enable energy development as well as ranching, grazing, timber production, and recreation across America's public lands.

Risk Management and Financial Assurance for OCS Lease and Grant Obligations, RIN 1010-AE26.

BOEM has reviewed market conditions of supply and demand in the crude oil and gas markets, and, as a result, is proposing to amend its existing risk management and financial assurance regulations. If finalized, this revision will reduce the economic burden on OCS lessees and grant holders and promote OCS oil and gas development. BOEM estimates that a reduction of approximately $6.2 billion of financial burden to the regulated community will be achieved through this rulemaking. This reduction of the financial burden increases the amount of capital available for oil and gas exploration and production on the OCS.

Rescission of the Management and Protection of the National Petroleum Reserve in Alaska Regulations, RIN 1004-AF02.

On November 17, 2025, BLM published the final rule, Rescission of the Management and Protection of the National Petroleum Reserve in Alaska Regulations. See 90 FR 51470. This final rule is a major step towards unlocking the energy potential of the roughly 23-million-acre reserve. This rule implements direction that President Trump issued on his first day in office through E.O. 14153 and responds to calls from Alaskans, including North Slope leaders, to rescind restrictive regulations that had downstream effects on energy development and economic growth.

Federal Oil, Gas, and Coal Amendments, RIN 1012-AA39.

Consistent with Executive and Secretary's orders, ONRR is proposing to clarify the scope of review for Director-level appeals and amend its Federal oil, gas, and coal valuation regulations. Through this rulemaking, ONRR seeks to propose changes that will reduce cost and burden to industry by simplifying regulatory requirements.

Rights-of Way, Leasing, and Operations for Renewable Energy, RIN 1004-AF32.

BLM intends to propose rescission of the final rule, Rights-of-Way, Leasing, and Operations for Renewable Energy. If finalized, the rule will eliminate biased renewable energy rules that advantage intermittent energy over other energy sources. “Eliminating the Biden administration's preferential treatment of unaffordable, unreliable intermittent projects and dismantling excessive, one-sided restrictions on traditional energy sources like oil, gas, and critical minerals, will unlock the full potential of America's natural resources,” said Secretary Burgum. “This step will restore balance, strengthens our energy independence, and ensures taxpayers get the maximum return from the responsible use of our public lands.” ^[6]

Oil and Gas Leasing Rescission Rule, RIN 1004-AF05.

BLM proposes revising its oil and gas regulations regarding allocation schedules in multi-party agreements that outline how royalties are distributed across different leases within the agreement. BLM also proposes to return the minimum bonds to the amounts that existed before the 2024 rule. Finally, the proposed rule would improve BLM's leasing process to ensure stewardship of public lands as required by the Mineral Leasing Act.

Royalty for Oil and Gas Lost from Onshore Federal and Indian Leases, 1004-AF33.

BLM proposes to modify its existing regulations pertaining to royalties due on oil and natural gas lost on Federal and Tribal leases. These modifications would reduce unnecessary compliance burdens for operators and streamline BLM's royalty determinations on lost oil or natural gas.

Revisions to the 2023 Well Control Rule, RIN 1014-AA63.

BSEE proposes to revise certain regulatory provisions in its 2023 well control rule (88 FR 57334, August 23, 2023) to clarify certain reporting and recordkeeping requirements. This rule would reduce duplicative submissions and provide consistency and clarity of information available for BSEE review.

Increase Access to Recreational Opportunities on Public Land

The Department manages 480 million acres of public land and welcomes over 565 million visitors each year. Interior offers recreational activities like hunting, fishing, boating, hiking, and sightseeing, which contribute over a trillion dollars to our Nation's economy.^[7] The Department seeks to increase access to these activities and improve access to public lands more generally. Rules that will further this goal include the following:

Process for Authorizing Seasonal Migratory Game Bird Hunting, RIN 1018-BI04.

To better meet Federal, State, and Tribal rulemaking needs, reduce the complexity and delays associated with the current process, and ensure the timely start to hunting seasons, FWS proposes a streamlined approach to authorizing annual hunting seasons. Essentially, FWS proposes to change the authorization process from promulgating annual Federal regulations with State hunting seasons to issuing general Federal regulations that authorize States to establish regulations for the seasonal hunting of migratory game birds in accordance with Federal authorization conditions and the general regulations.

Deregulatory Actions for Migratory Bird and Eagle Permits, RIN 1018-BF58.

FWS proposes to deregulate migratory bird and eagle permitting to better serve the American public, streamline government operations, and reduce permitting requirements. FWS proposes to leverage technology in support of innovative approaches to permitting by using general permits and regulatory authorizations. Specifically, FWS would create a general permit option for 75 percent of existing migratory bird and eagle-specific permits, primarily those that authorize possessions such as exhibition and breeding. FWS also proposes replacing the current paper system with an electronic registration system for the eight existing depredation and control orders that authorize take of depredating, ( printed page 52878) overabundant, or otherwise injurious birds. FWS also intends to eliminate situations where previously two Federal permits were required for the same or similar actions.

Annual station-specific hunting and fishing regulations, RIN 1018-BI01.

FWS annually proposes regulatory additions and revisions to hunting and fishing at its national wildlife refuges and fish hatcheries. These actions are part of an annual update for the national wildlife refuge and the national fish hatchery systems to ensure adequate public notice of openings and changes. These actions enhance conservation stewardship and outdoor recreation and improve the management of game species and their habitat. FWS seeks to maximize hunting and fishing opportunities at its refuges and hatcheries to benefit the American people.

Alaska Hunting and Trapping in National Preserves, RIN 1024-AE96.

The National Park Service (NPS) proposes to amend its regulations for hunting, fishing, trapping, and other natural resource harvest in national preserves in Alaska and for the procedures used to restrict public use and access in Alaska park lands. These changes restore regulations adopted to implement the Alaska National Interest Lands Conservation Act of 1980 (P.L. 96-487) that were in effect for several decades, which allows for bear baiting consistent with State law. Rulemaking in 2015, 2017, and 2024 preempted methods of State-authorized fish and wildlife harvests, revised codified and established procedures for restricting public access and activities in Alaska park lands. This rulemaking would walk back those 2024 changes.

Additional Regulatory Priorities by Bureau

The following sections give an overview of some of the other major deregulatory and regulatory priorities of the Department's Bureaus and Offices in FY 2026.

I. Bureau of Indian Affairs

The Bureau of Indian Affairs (BIA) enhances the quality of life, promotes economic opportunity, and protects and improves the trust assets of approximately 1.9 million American Indians, Indian Tribes, and Alaska Natives. BIA maintains a government-to-government relationship with the 573 federally recognized Indian Tribes. BIA also administers and manages 55 million acres of surface land and 57 million acres of subsurface minerals held in trust by the United States for American Indians and Indian Tribes.

Other Deregulatory and Regulatory Actions

Leasing of Osage Reservation Lands for Oil and Gas Mining, RIN 1076-AF59.

The proposed rule was published on January 13, 2023 (88 FR 2430). This final rule will revise the regulations in 25 CFR part 226 to strengthen BIA's management of the Osage mineral estate and improve accounting and production measurement standards; offer consistency in production valuation; address inadequate bonding; support the implementation of electronic reporting systems; enhance accountability; clarify lessees' obligations; prevent waste; promote safe and environmentally sound operations; and protect resource values. The Department received Tribal government input through consultation sessions held pursuant to E.O. 13175 and the Department's policy on communication and collaboration with Tribal officials.

Agricultural Leasing of Indian Land, RIN 1076-AF66.

This proposed rule would update provisions addressing leasing of Indian trust or restricted lands for agricultural purposes to reflect updates that have been made to business and residential leasing provisions and address outdated provisions.

Mineral Leasing Regulations, RIN 1076-AF76.

This rule proposes to modernize the Department's trust responsibility in the areas of energy and minerals. This rule would propose to increase the benefit to Indian beneficiaries by revising definitions, authorities, bonding requirements, royalty rates, and leasing and cooperative agreements. The Department will seek Tribal government input through consultation sessions held pursuant to E.O. 13175 and the Department's policy on communication and collaboration with Tribal officials

II. Bureau of Land Management

BLM manages more than 245 million acres of public land, known as the National System of Public Lands, primarily located in 12 Western States, including Alaska. BLM also administers 700 million acres of sub-surface mineral estate throughout the Nation. As a steward, BLM pursues its multiple-use mission, providing opportunities for economic growth through uses such as energy development, ranching, mining and logging, as well as outdoor recreation activities such as camping, hunting, and fishing, while also supporting conservation efforts. Public lands provide valuable, tangible goods and materials that we, as Americans, use every day to heat our homes, build our roads, and feed our families. BLM strives to be a good neighbor in the communities it serves and is committed to keeping public landscapes healthy and productive.

Other Regulatory and Deregulatory Actions

In addition to the deregulatory and regulatory actions addressed above, the BLM intends to propose rules in FY 2026 re-imagining its grazing regulations, land use planning regulations, and regulations governing areas of critical environmental concern, among others. These rules would help lower the price of beef by, among other things, increasing the amount of cattle grazing on public lands and eliminate red tape that is slowing down BLM's execution of its multiple-use mandate.

Specifically, under the rulemaking, Grazing Administration- Exclusive of Alaska (RIN 1004-AE82), BLM will be revisions to the livestock grazing regulations found at 43 CFR part 4100. This rulemaking includes removing subpart 4180 from the grazing regulations and moving the Fundamentals of Rangeland Health to Part 1700 for the evaluation and achievement of the fundamentals of land health across all BLM programs. The proposed revisions are intended to modernize the BLM's grazing program, increase flexibility for ranchers, better protect rangeland health, and align with amendments to the Federal Land Policy and Management Act (FLPMA) and recommendations of the Government Accountability Office.

For the land use planning regulations, BLM will be proposing the Planning and Designation of Areas of Critical Environment Concern ((RIN 1004-AF53) which intends to modernize the BLM's land use planning. The proposed rule would eliminate unnecessary procedures that impose delays and roadblocks to an efficient process and remove program-specific procedures from the planning regulations while improving the BLM's coordination responsibilities in a more streamlined process. The proposed rule would also improve the readability of the planning regulations.

III. Bureau of Ocean Energy Management

BOEM is committed to ongoing efforts and initiatives vital to its mission to manage development of the Nation's offshore energy, mineral, and geological resources in an environmentally and economically responsible way. BOEM's mission is foundational to advancing the administration's oil and gas energy policies on the OCS. ( printed page 52879)

Offshore energy development is a vital component of U.S. national security and a critical driver of American prosperity. In accordance with E.O. 14154 and SO 3418, both titled “Unleashing American Energy,” E.O. 14192, titled “Unleashing Prosperity Through Deregulation,” and SO 3421, titled “Achieving Prosperity Through Deregulation,” BOEM is committed to the safe development of our offshore energy and mineral resources, with the goal of decreasing regulatory burdens that unnecessarily restrict energy production, constrain economic growth, and prevent job creation. During the coming year, BOEM will continue to be committed to identifying deregulatory opportunities and policies that lower costs and boost exploration, investment, development, and production.

Other Deregulatory and Regulatory Actions

Offshore Wind Regulatory Reform, RIN 1010-AE38.

As part of the Interior Department's full review of offshore wind energy regulations to ensure alignment with the Outer Continental Shelf Lands Act and the President's energy priorities, BOEM will propose revisions to the offshore wind regulations addressing bidding credits and financial assurance.

IV. Bureau of Safety and Environmental Enforcement

BSEE's mission is to promote offshore development and production of energy resources, while ensuring that offshore operations are safe and environmentally sound. BSEE's priorities in fulfillment of its mission are to, promote and regulate offshore energy development and build and sustain the organizational, technical, and intellectual capacity within and across BSEE's key functions in order to keep pace with offshore industry technology improvements, innovate in economically sound regulation and enforcement, and reduce risk through appropriate risk assessment and regulatory and enforcement actions.

Consistent with the direction in E.O. 14154 and SO 3418, both titled “Unleashing American Energy,” E.O. 14192, titled “Unleashing Prosperity Through Deregulation,” and SO 3421, titled “Achieving Prosperity through Deregulation,” BSEE has reviewed and will continue to review its existing regulations to determine whether they unnecessarily burden the development or use of domestically produced energy resources, constrain economic growth, or prevent job creation. BSEE is a well-positioned partner ready to help all stakeholders maintain the Nation's position as a global energy leader and foster energy independence for the benefit of the American people, while ensuring that offshore oil and gas activity on the OCS is performed in a safe and environmentally responsible manner.

Other Deregulatory and Regulatory Actions

Updates of Documents Incorporated by Reference—Oil and Gas and Sulphur Operations in the Outer Continental Shelf, RIN 1014-AA56.

BSEE proposes to update the editions of industry documents ( e.g., standards incorporated by reference in 30 CFR part 250). BSEE incorporates by reference over 125 standards in its regulations. Incorporation of a specific edition of a standard into the regulations requires the regulated industry to comply with the terms of that edition and will promote regulatory clarity.

Oil-Spill Response Requirements for Facilities Located Seaward of the Coast Line, RIN 1014-AA44.

BSEE proposes to update its existing regulations to incorporate the latest advancements in spill response and preparedness policies and technologies. These advancements include recent lessons learned and recommendations from reports related to the Deepwater Horizon explosion and subsequent oil spill..

Revisions to Subpart J—Pipelines and Pipeline Rights-of-Way, RIN 1014-AA45.

BSEE proposes to revise specific provisions of the current pipelines and pipeline rights-of-way regulations under 30 CFR part 250, subpart J. This proposed rule would align with current technology and state-of-the-art safety equipment and procedures, primarily through the incorporation of industry standards.

V. Office of Natural Resources Revenue

ONRR collects, accounts for, and disburses revenues from Federal offshore energy and mineral leases and from onshore mineral leases on Federal and Indian lands. ONRR operates nationwide and is primarily responsible for timely and accurate collection, distribution, and accounting for revenues associated with mineral and energy production.

Other Deregulatory and Regulatory Actions

Federal Oil, Gas, and Coal Amendments, RIN 1012-AA39.

ONRR proposes to amend its oil, gas, and coal valuation regulations and to specify the standard of review for Director-level appeals. This proposed rule likely would reduce cost and administrative burden to industry and the Federal Government by simplifying regulatory requirements and would ultimately incentivize production to unleash energy dominance.

VI. Office of Surface Mining Reclamation and Enforcement (OSMRE)

OSMRE was created by the Surface Mining Control and Reclamation Act of 1977 (SMCRA). Under SMCRA, OSMRE has two principal functions, regulation of surface coal mining and reclamation operations, and reclamation and restoration of abandoned coal mine lands. In enacting SMCRA, Congress directed OSMRE to “strike a balance between protection of the environment and agricultural productivity and the Nation's need for coal as an essential source of energy.” OSMRE seeks to develop and maintain a regulatory program that provides a safe, cost-effective, and environmentally sound supply of coal to help support the Nation's economy and local communities.

Other Deregulatory and Regulatory Actions

Rescission of the “Ten-Day Notices and Corrective Action for State Regulatory Program Issues” Rule, Issued April 9, 2024, RIN 1029-AC89.

OSMRE proposed rescinding the Biden-era 10-day notices and corrective action rule. This rescission would align the regulations with the single, best meaning of the statutory language in SMCRA, streamline OSMRE's coordination with State regulatory authorities to minimize duplication of efforts, and appropriately recognize that State regulatory authorities are the primary regulatory authorities of non-Federal, non-Indian lands within their borders.

VII. National Park Service

NPS preserves the natural and cultural resources and values within 433 units of the National Park System encompassing more than 85 million acres of lands and waters for the enjoyment, education, and inspiration of this and future generations.

Other Deregulatory and Regulatory Actions

During the coming year, NPS plans to develop deregulatory actions that further the purposes ofE.O. 14192 “Unleashing Prosperity Through Deregulation,” E.O. 14153 “Unleashing Alaska's Extraordinary Resource Potential,” E.O. 14219 “Ensuring Lawful ( printed page 52880) Governance and Implementing the President's `Department of Government Efficiency' Initiative,” and E.O. 14314 “Making America Beautiful Again by Improving Our National Parks.” These actions will create new opportunities for recreational access in park areas through off-road vehicle use, bicycling, horseback riding, fishing, hiking, use of powered micromobility devices ( e.g., e-scooters), use of motorized vessels and personal watercraft, and hunting and trapping.

In addition to the Alaska Hunting and Trapping in National Preserves rule referenced above, NPS highlights the following deregulatory actions:

- Olympic National Park; Fishing (1024-AF00). This rule would give the superintendent more flexibility to allow salmon fishing in park waters, consistent with a new fishery management plan under development. This could result in the NPS opening the Elwha River to salmon fishing by the general public for the first time in decades. This would create a new, highly anticipated opportunity for recreational fishing in the park, consistent with the direction in Executive Order 14314, Making America Beautiful Again by Improving Our National Parks, to improve the recreational experience in national parks for American residents.
- Revisions to Bicycle Regulations (1024-AE97). This rule would remove unnecessary procedural requirements for the designation of trails for bicycle use in park areas. Existing regulations require the NPS to prepare an environmental assessment or an environmental impact statement to evaluate the potential impacts of bicycle use whether or not they would be required by the National Environmental Policy Act (NEPA). As a result, the NPS conducts levels of review that may not be justified by the scope of the action or needed under Federal law. These regulations should therefore be modified consistent with the direction in Executive Order 14219, “Ensuring Lawful Governance and Implementing the President's `Department of Government Efficiency' Deregulatory Initiative.” By streamlining the process for designating trails for bicycle use in park areas, this rule may lead to increased opportunities for recreation and access in park areas thereby improving the recreational experience in national parks for American residents, consistent with Executive Order 14314.

VIII. Other Regulatory Actions of the Department of the Interior

Practices Before the Department of the Interior. RIN 1094-AA57.

The Office of Hearings and Appeals (OHA) will make comprehensive procedural changes to Federal regulations governing hearings and appeals proceedings before Interior's administrative tribunals. OHA will modify and update its regulations located in title 43 of the Code of Federal Regulations in parts 4 and 30 to: (1) promote expeditious and meaningful review of administrative decisions; (2) reflect changes in the law; (3) reorganize and streamline procedures and retitle subparts to improve clarity to parties; (4) consolidate redundant language; (5) eliminate outdated procedures; and (6) allow OHA to continue to modernize its practice and keep pace with technological and other advancements, including the establishment of a regulatory framework for an electronic filing and case docket management system.

BILLING CODE 4334-63-P

DOI—Bureau of Ocean Energy Management (BOEM)	Proposed Rule Stage

89. • OFFSHORE WIND REGULATORY REFORM

Priority: Other Significant. Major status under 5 U.S.C. 801 is undetermined.

Regulatory Accounting: Regulatory

Legal Authority: Outer Continental Shelf Lands Act

Relevant Executive Orders: 14315

CFR Citation: 30 CFR 585

Legal Deadline: None

Abstract: This rule will propose revisions to the offshore wind regulations. In 2024, BOEM promulgated the Renewable Energy Modernization Rule. Now, to support Executive Order 14315 and Secretary's Order 3437, and in accordance with the Department's August 7, 2025, announcement, BOEM will update the offshore wind regulations.

Statement of Need: The Department of the Interior, acting through the Bureau of Ocean Energy Management is proposing this regulatory action to support Executive Order 14315, Ending Market Distorting Subsidies for Unreliable, Foreign-Controlled Energy Sources (July 7, 2025), Secretary's Order 3437, Ending Preferential Treatment for Unreliable, Foreign-Controlled Energy Sources in Department Decision-Making (July 29, 2025), and the President's memorandum, Temporary Withdrawal of All Areas on the Outer Continental Shelf from Offshore Wind Leasing and Review of the Federal Government's Leasing and Permitting Practices for Wind Projects (January 20, 2025).

Summary of Legal Basis: Congress authorized the Secretary to grant OCS leases for renewable energy activities when it enacted the Energy Policy Act of 2005, which amended the Outer Continental Shelf Lands Act (OCSLA) by adding a new subsection 8(p), codified at 43 U.S.C. 1337(p). Subsection 8(p) of OCSLA authorizes the Secretary to award OCS leases, pipeline ROW grants, and RUE grants for activities not otherwise authorized by other applicable law, if those activities produce or support production, transportation, storage, or transmission of energy sources other than oil or gas.

Subsection 8(p) requires the Secretary to award such leases, ROWs, and RUEs on a competitive basis unless the Secretary determines, following public notice, that competitive interest does not exist. Additionally, subsection 8(p) also authorizes the Secretary to issue regulations to carry out the subsection's grant of authority. The Secretary delegated that authority to BOEM's and BSEE's predecessor, the Minerals Management Service. Subsection 8(p)(8) of OCSLA (43 U.S.C. 1337(p)(8)) authorizes the Secretary to issue any necessary regulations to carry out this subsection.

Alternatives: TBD

Anticipated Cost and Benefits: TBD

Risks: TBD

Timetable:

Action	Date	FR Cite
NPRM	08/00/26

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: Undetermined

Agency Contact: Karen Thundiyil, Director, Office of Regulatory Affairs, Department of the Interior, Bureau of Ocean Energy Management, 1849 C Street NW, Washington, DC 20240

Phone: 202 742-0970

Email: karen.thundiyil@boem.gov

RIN: 1010-AE38

BILLING CODE 4334-63-P

Department of Justice (DOJ)

Statement of Regulatory Priorities

The mission of the Department of Justice is to uphold the rule of law, to keep our country safe, and to protect civil rights. In carrying out this mission, the Department is guided by the core ( printed page 52881) values of excellence, integrity, fairness, and commitment to promoting the impartial administration of justice. Consistent with its mission and values, the Department is prioritizing activities that protect the public against foreign and domestic threats, enforce immigration laws, strengthen enforcement of civil rights laws, defend against domestic and international terrorism, combat violent crime while protecting Second Amendment rights and reducing unnecessary burdens on the regulated communities, prevent and control crime, and uphold our system of criminal justice. Because the Department of Justice is primarily a law enforcement agency, not a regulatory agency, it carries out its principal investigative, prosecutorial, and other enforcement activities through means other than the regulatory process.

Regulatory action is, however, a significant aspect of the mission of the Department. The regulatory priorities of the Department include initiatives in the areas of effective law enforcement, immigration enforcement, civil rights, and illicit firearms trafficking reduction, and are effectuated through rulemaking by the various components of the Department. These initiatives, as well as others important to components' accomplishing key law enforcement priorities, are summarized below.

Bureau of Alcohol, Tobacco, Firearms and Explosives (ATF)

ATF issues regulations to enforce and implement Federal laws relating to the manufacture, importation, sale, and other commerce in firearms and explosives. Such regulations are designed to promote the ATF mission to curb illegal traffic in, and criminal use of, firearms and explosives, and to assist state, local, Tribal, territorial, and other Federal law enforcement agencies in reducing violent crime.

ATF will, as a priority during fiscal year 2026, streamline firearms and explosives regulations to reduce unnecessary burdens on the public consistent with Federal laws governing commerce in firearms and explosives. In this way, ATF's approach is animated by an interest in deregulation. ATF is pursuing a large rulemaking initiative, which includes updating regulations, so the firearms industry and public are not subject to inadvertent regulatory traps, removing outdated and repetitive regulations, and reducing regulatory burdens to promote business efficiencies while still promoting public safety. As one priority, ATF is undertaking amendments to the regulations that govern firearms transactions and the Firearms Transaction Record, ATF Form 4473. The rulemaking will streamline identity and residence verification requirements, double the performance timeframe for transactions following a Form 4473 and background check, permit electronic forms and notices as well as auto-populating documents, and address private party transfers and firearms handlers checks (RIN 1140-AA82). As another priority, ATF is amending its regulations to conform with the One Big Beautiful Bill Act (OBBBA), which reduced the tax liability for certain firearms subject to the National Firearms Act of 1934 from $200 to $0, effective January 1, 2026 (RIN 1140-AA83). ATF is also amending the regulatory definition of “machine gun” in response to the Supreme Court decision in Garland v. Cargill to remove any language pertaining to bump-stock devices (RIN 1140-AA60) and is rescinding the final rule “Factoring Criteria for Firearms with Attached `Stabilizing Braces',” as it has rarely been in effect since its publication due to ongoing litigation.

ATF's continuing priorities include proposing a rulemaking to update certain provisions of the Federal explosives regulations at 27 CFR part 555, most of which have not been updated since the early 1970s (RIN 1140-AA59). The rulemaking is expected to be deregulatory in nature and address certain definitions of commonly used terms, consolidate licensing and permitting, simplify record-keeping provisions, and clarify certain aspects of storing and identifying explosive materials by multiple licensees using a single magazine. ATF is also publishing a final rule aimed at protecting first responders that industry has long recommended as a safety measure. The final rule amends 27 CFR part 555 to require persons who are subject to explosives regulations, and thus already report to the local authority with jurisdiction for fire safety in the locality when they begin storing explosive materials at a location, to annually notify that local authority of the current type, quantity, and location of each site where the licensee is storing explosive materials within that jurisdiction (RIN 1140-AA51).

Bureau of Prisons (BOP)

BOP issues regulations to enforce the Federal laws relating to its mission to protect public safety by ensuring that Federal offenders serve their sentences of imprisonment in facilities that are safe, humane, cost-efficient, and appropriately secure, and to provide reentry programming to ensure their successful return to the community.

The First Step Act (FSA) of 2018, Public Law 115-391, 132 Stat. 5194 (2018), has brought a host of regulatory changes for BOP. To date, BOP has successfully enacted FSA-related regulations (1) to enable eligible inmates to earn Time Credits towards prerelease custody or early transfer to supervised release, and (2) to modify the amount of Good Time Credit to which eligible inmates are entitled.

BOP has two remaining FSA-related regulatory measures it plans to finalize. The first involves the Reservation of Funds for Reentry Under the First Step Act final rule, which will implement an FSA provision requiring BOP to reserve a portion of the compensation inmates would otherwise receive for working to assist these inmates with costs associated with release from prison. The second involves promulgating an interim final rule that changes two specific sections of the First Step Act Time Credits regulation to conform with recent case law trends.

In February 2024, BOP published a notice of proposed rulemaking (NPRM) titled Inmate Discipline Program: Disciplinary Segregation and Prohibited Act Code Changes, which proposed several significant revisions and updates to the Inmate Discipline Program. BOP continues to work toward a final rule.

Finally, BOP continues to take the lead on updating and clarifying certain standards related to the Prison Rape Elimination Act (PREA), working toward publication of a proposed rule before the end of 2025.

Civil Rights Division (CRT)

CRT works to uphold the civil and constitutional rights of all persons in the United States, particularly some of the most vulnerable members of our society, and also works to facilitate compliance among regulated entities by addressing the regulatory burdens they face. Consistent with this mission, CRT plans to engage in four separate rulemakings on disability rights.

First and second, under Section 610 of the Regulatory Flexibility Act (5 U.S.C. 610), CRT intends to review the Americans with Disabilities Act title II and title III regulations issued in 2010, at 28 CFR 35 and 28 CFR 36 respectively, to determine whether updates are necessary. Third, CRT plans to reconsider whether some of the regulatory provisions imposed by the April 24, 2024, title II rule regarding the accessibility of web information and the services of state and local government entities could be made less burdensome and the deadlines for implementation extended. Fourth, CRT is proposing to revise the ADA title III regulations to ( printed page 52882) establish specific criteria for determining when qualified small businesses are presumed to be in compliance with their obligation to remove readily achievable barriers in existing facilities.

Drug Enforcement Administration (DEA)

DEA is primarily responsible for coordinating the drug law enforcement activities of the United States and assisting in the implementation of the President's National Drug Control Strategy. DEA implements and enforces titles II and III of the Comprehensive Drug Abuse Prevention and Control Act of 1970 and the Controlled Substances Import and Export Act (21 U.S.C. 801-971), as amended, collectively referred to as the Controlled Substances Act (CSA).

DEA's mission is to enforce the controlled substances laws and regulations of the United States and bring to the criminal, civil, and administrative justice systems those organizations and individuals involved in the growing, manufacture, or distribution of controlled substances and listed chemicals appearing in or destined for illicit traffic in the United States. The CSA and its implementing regulations are designed to prevent, detect, and eliminate the diversion of controlled substances and listed chemicals into the illicit market while providing for the legitimate medical, scientific, research, and industrial needs of the United States.

Pursuant to its statutory authority, DEA intends to continue with the following priority regulations:

On December 31, 2025, DEA, jointly with the Department of Health and Human Services, issued a fourth temporary extension (Fourth Temporary Rule) extending the full set of telemedicine flexibilities regarding prescription of controlled medications as were in place during the COVID-19 public health emergency, through December 31, 2026. This extension authorized all DEA-registered practitioners to prescribe schedule II-V controlled medications via telemedicine through December 31, 2026.

On January 17, 2025, DEA promulgated the “Special Registrations for Telemedicine and Limited State Telemedicine Registrations” NPRM, which proposed a framework for a Special Registration for telemedicine, authorizing practitioners and mid-level practitioners to prescribe controlled substances via audio-video telemedicine (and in limited instances, video-only telemedicine) without having ever conducted a prior in-person medical evaluation, provided they adhere to the proposed prescription, recordkeeping, and reporting requirements. The NPRM also proposed to require that certain Direct-to-Consumer (DTC) telemedicine platforms register with DEA when they engage in intermediary conduct integral to the provider-patient relationship.

DEA is currently reviewing the over 6,400 public comments submitted on the Special Registration for Telemedicine (RIN 1117-AB40).

DEA intends to publish a final regulation to revise its regulations relating to suspicious orders of controlled substances found at 21 CFR 1301.74 and 21 CFR 1301.76. DEA published an NPRM titled Suspicious Orders of Controlled Substances in November of 2020, that proposed to define the term suspicious order and specify the procedures a registrant must follow upon receiving such orders. Due to the large volume of public comments, DEA reopened the comment period until March 29, 2021 (RIN 1117-AB47).

Executive Office for Immigration Review (EOIR)

EOIR's primary mission is to adjudicate immigration cases by fairly, expeditiously, and uniformly interpreting and administering the Nation's immigration laws. Under delegated authority from the Attorney General, EOIR conducts Immigration Court proceedings under the Office of the Chief Immigration Judge (OCIJ), appellate reviews by the Board of Immigration Appeals (BIA or the Board) of Immigration Judge decisions and other matters specified by regulation, and administrative hearings involving immigration-related employment practices, discrimination claims, and document fraud cases under the Office of the Chief Administrative Hearing Officer (OCAHO). In Fiscal Year 2024, Immigration Judges adjudicated over 700,000 cases to determine whether aliens should be ordered removed from the United States or whether they are eligible for relief or protection from removal.

EOIR's top regulatory priorities focus on revising and updating regulations to increase efficiency in Immigration Court proceedings and enable adjudicators to quickly resolve immigration cases, thereby reducing the backlog of pending cases before EOIR. For example, EOIR is working to finalize a rulemaking that would implement the statutorily provided contempt authority, which will allow Immigration Judges to better control their courtrooms by imposing civil money penalty sanctions on individuals who engage in contemptuous behavior that delays, disrupts, or obstructs the due course of immigration proceedings (RIN 1125-AB02). EOIR is also finalizing a regulation implementing electronic filing and records applications for all cases before OCAHO (RIN 1125-AB23). This regulation will mandate electronic filing for most parties in proceedings before OCAHO, which will create significant efficiencies by reducing labor costs associated with using paper case files and allowing case deadlines to be set quickly since electronic filings do not require additional time to account for paper mail delivery. Finally, pursuant to the OBBBA, EOIR is finalizing a rule to update relevant EOIR regulations governing fees to ensure full regulatory consistency with OBBBA's statutory changes.

Federal Bureau of Investigation (FBI)

The FBI is responsible for protecting and defending the United States against terrorist and foreign intelligence threats, upholding and enforcing the criminal laws of the United States, and providing leadership and criminal justice services to Federal, state, local, tribal, territorial, and international agencies and partners. Only in limited contexts does the FBI rely on rulemaking.

The FBI intends to publish a proposed rule regarding additional permissible uses of the National Instant Criminal Background Check System (NICS). This proposed rule will, among other things, allow Federal firearms licensees (FFLs) to query the NICS regarding proposed transfers of privately owned firearms and will allow for further uses of the NICS Indices by criminal justice agencies, the FBI, ATF, the Nuclear Regulatory Commission, and other authorized agencies.

The FBI intends to publish a final rule regarding criteria for NICS checks concerning firearm handlers and other eligible employees. This final rule will implement a portion of the Bipartisan Safer Communities Act (BSCA), 34 U.S.C. 40901, by authorizing and establishing the process for FFLs to use NICS for the purpose of voluntarily conducting background checks of certain current and/or prospective employees of the FFL, to determine whether such employees are prohibited from possessing or receiving firearms. (RIN 1100-AA35).

Finally, the FBI continues to actively work on additional regulatory actions to implement other BSCA provisions, the Child Protection Improvement Act, and the Private Security Officer Employment Authorization Act that are on its long-term regulatory docket. ( printed page 52883)

National Security Division (NSD)

In December 2021, the Department published a National Security Division (NSD) Advance Notice of Proposed Rulemaking (ANPRM) (86 FR 70787) soliciting comments about potential revisions to the Foreign Agents Registration Act (FARA) regulations. Based on comments received, the Department published an NPRM (90 FR 40) in early January 2025. NSD has previously carefully considered comments received in response to the NPRM, and is now considering a final rule that adopts many—but not all—of the NPRM's proposals. Among others, changes anticipated in the final rule will expand the availability of exemptions commonly relied upon by corporations and law firms and provide requested clarity on labeling digital media. In sum, the final rule will clarify ambiguities in the existing regulations, update the regulations to keep pace with technological change, and improve civil FARA administration while reducing regulatory burdens on the public.

Additional Noteworthy Regulations

The Department of Justice is updating its existing procedures in 28 CFR part 61 concerning compliance with the National Environmental Policy Act (NEPA). The updates are necessary to respond to guidance issued by the Council on Environmental Quality, as well as amendments to NEPA made in 2023 by the Fiscal Responsibility Act.

The Department of Justice is also releasing a set of procedures and criteria in 28 CFR part 107 regarding Applications for Relief from Disabilities Imposed by Federal Laws with Respect to the Acquisition, Receipt, Transfer, Shipment, Transportation, or Possession of Firearms. The rule resurrects a moribund process under 18 U.S.C. 925(c) that had previously been effectuated by the ATF. In July, the Department issued an NPRM outlining the proposed criteria and guidelines for members of the public to apply for this new process. The comment period for this proposal ended in October 2025. The Department is reviewing comments and working to draft a final rule which will adopt many of the proposed rule's criteria. The development of this rule was necessary to satisfy the public's request for relief under this long-dormant provision, and the Department is committed to providing this valuable service in support of citizens' Second Amendment rights.

BILLING CODE 4410-BP-P

DOJ—Drug Enforcement Administration (DEA)	Final Rule Stage

90. SPECIAL REGISTRATIONS FOR TELEMEDICINE AND LIMITED STATE TELEMEDICINE REGISTRATIONS

Priority: Economically Significant

Regulatory Accounting: Deregulatory

Legal Authority: 21 U.S.C. 831(h); 21 U.S.C. 802(54); Pub. L. 115-271, sec. 3232

Relevant Executive Orders: 12866; 13563

CFR Citation: 21 CFR 1301

Legal Deadline: Final, Statutory, October 24, 2019.

Abstract: The Ryan Haight Online Pharmacy Consumer Protection Act of 2008 (the Act) (Pub. L. 110-425) was enacted on October 15, 2008, and amended the Controlled Substances Act by adding various provisions to prevent the illegal distribution and dispensing of controlled substances by means of the internet. Among other things, the Act required an in-person medical evaluation as a prerequisite to prescribing or otherwise dispensing controlled substances by means of the internet, except in the case of practitioners engaged in the practice of telemedicine. The definition of the “practice of telemedicine” includes seven distinct categories that involve circumstances in which the prescribing practitioner might be unable to satisfy the Act's in-person medical evaluation requirement yet nonetheless has sufficient medical information to prescribe a controlled substance for a legitimate medical purpose in the usual course of professional practice. One specific category within the Act's definition of the “practice of telemedicine” includes “a practitioner who has obtained from the [DEA Administrator] a special registration under [21 U.S.C. 831(h)].” 21 U.S.C. 802(54)(E). The Act also specifies certain criteria that the DEA must consider when evaluating an application for such a registration. However, the Act contemplates that the DEA must issue regulations to effectuate this special registration provision.

On January 17, 2025, DEA promulgated the Special Registrations for Telemedicine and Limited State Telemedicine Registrations NPRM, which proposed a framework for a Special Registration for telemedicine, authorizing practitioners and mid-level practitioners to prescribe controlled substances via audio-video telemedicine (and in limited instances, video-only telemedicine) without having ever conducted a prior in-person medical evaluation, provided they adhere to the proposed prescription, recordkeeping, and reporting requirements. The NPRM also proposed to require that certain Direct-to-Consumer (DTC) telemedicine platforms register with DEA when they engage in intermediary conduct integral to the provider-patient relationship.

Statement of Need: DEA is currently reviewing the over 6,400 public comments submitted on the Special Registration for Telemedicine NPRM published on January 17, 2025, and is considering various alternatives in drafting a Final Rule for Telemedicine Prescribing of Controlled Substances when the Practitioner and the Patient Have Not Had a Prior In-Person Medical Evaluation in order to promulgate effective regulations responsive to the general public and industry concerns.

Summary of Legal Basis: DEA implements and enforces the CSA and the Controlled Substances Import and Export Act, (21 U.S.C. 801-971), as amended. DEA publishes the implementing regulations for these statutes in 21 CFR parts 1300 to end. These regulations are designed to ensure a sufficient supply of controlled substances for medical, scientific, and other legitimate purposes, and to deter the diversion of controlled substances for illicit purposes.

As mandated by the CSA, DEA establishes and maintains a closed system of control for manufacturing, distribution, and dispensing of controlled substances, and requires any person who manufactures, distributes, dispenses, imports, exports, or conducts research or chemical analysis with controlled substances to register with DEA, unless they meet an exemption, pursuant to 21 U.S.C. 822. The CSA further authorizes the Administrator to promulgate regulations necessary and appropriate to execute the functions of subchapter I (Control and Enforcement) and subchapter II (Import and Export) of the CSA. 21 U.S.C. 871(b), 958(f).

Alternatives: DEA is considering various alternatives, particularly the proposed requirements outlined in the January 17, 2025, NPRM.

Anticipated Cost and Benefits: DEA anticipates this rule will be economically significant (that is, that the rule will have an annual effect on the economy of $100 million or more, or adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, territorial, or tribal governments or communities). DEA believes the rule will reduce the cost of providing and receiving medical care, increasing access, particularly for those ( printed page 52884) patients where an in-person medical evaluation is difficult, such as patients in rural areas and with disabilities.

Risks: Failing to issue a rule on telemedicine would interfere with DEA's mission to prevent, detect, and investigate the diversion of controlled pharmaceuticals and listed chemicals from legitimate sources while ensuring an adequate and uninterrupted supply for legitimate medical, commercial, and scientific needs.

Timetable:

Action	Date	FR Cite
NPRM	03/01/23	88 FR 12875
NPRM Comment Period End	03/31/23
Temporary Rule	05/10/23	88 FR 30037
Temporary Rule Effective	05/11/23
Second Temporary Rule	10/10/23	88 FR 69879
Second Temporary Rule Effective	11/11/23
Third Temporary Rule	11/19/24	89 FR 91253
Third Temporary Rule Effective	01/01/25
NPRM	01/17/25	90 FR 6541
Fourth Temporary Rule	12/31/25	90 FR 61301
Fourth Temporary Rule Effective	01/01/26
Final Action	11/00/26

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Additional Information: DEA Docket number 407/Related rule 1117-AB88 DEA407VA

URL For More Information: DPW@dea.gov

URL For Public Comments: www.regulations.gov

Agency Contact: Heather E. Achbach, Acting Section Chief, Regulatory Drafting and Support Section, Department of Justice, Drug Enforcement Administration, Diversion Control Division, 8701 Morrissette Drive, Springfield, VA 22152

Phone: 571 387-3185

Email: heather.e.achbach@dea.gov

Related RIN:

Related to 1117-AB88

RIN: 1117-AB40

BILLING CODE 4410-BP-P

Department of Labor

2026 Regulatory Plan

Executive Summary: Putting the American Worker First

The Department of Labor's mission is to foster, promote, and develop the welfare of America's wage earners, job seekers, and retirees; improve working conditions; advance opportunities for profitable employment; and assure work-related benefits and rights. The Department advocates for workers by ensuring that employers are held accountable for their legal obligations, while helping employers understand and comply with the many laws and regulations affecting their workplaces.

Under President Trump's leadership, the Department will continue to place American workers first by focusing on policies that protect American jobs, reduce unnecessary burdens on employers and workers alike, and ensure workers share in the benefits of a strong economy.

The Department's regulatory agenda is guided by the President's Executive Orders. Consistent with Executive Order E.O. 14192, Unleashing Prosperity Through Deregulation, the Department is rescinding and revising unlawful, unconstitutional, and overly burdensome rules that have stifled growth, imposed costs, and limited opportunity for workers and employers alike. Under the Executive Order Restoring Merit-Based Opportunity, the Department is proposing to end government mandates that pressured employers and contractors to make employment decisions based on race, sex, gender identity, and similar classifications. This includes eliminating divisive Diversity, Equity, and Inclusion (DEI) requirements that encouraged unlawful group preferences. The Department reaffirms the American principle that hiring, promotion, and opportunity should be based on merit, not identity politics. Consistent with Executive Orders 13877, Improving Price and Quality Transparency in American Healthcare to Put Patients First, and 14274, Lowering Drug Prices by Once Again Putting Americans First, the Department will continue efforts to make health care coverage more affordable and understandable for workers and retirees. Finally, pursuant to Executive Order 14154, Unleashing American Energy, the Department is aligning workplace standards with the goals of energy independence and economic strength. A central part of this strategy is maintaining protections for miners while ensuring America's energy producers can expand operations without facing duplicative or unnecessary regulatory burdens.

The Department is committed to fully and fairly enforcing the laws under its jurisdiction. The vast majority of employers work hard to keep their workplaces safe and to comply with wage and pension laws. Acknowledging this, the Department is working to provide compliance assistance, including through self-audit programs and the relaunch and expansion of the opinion letter program, to give employers the knowledge and tools they need to comply with their legal obligations.

The Department's Regulatory Plan To Accomplishing These Objectives

The Department's regulatory approach in 2026 will emphasize clarity, restraint, and accountability. The Department recognizes that workers benefit most from a strong and growing economy, and that excessive, unlawful, or poorly tailored regulation can reduce opportunity, raise costs, and weaken the very protections it was intended to promote.

To carry out its mission, the Department will rely on three core strategies. First, it will faithfully enforce the laws Congress has enacted, ensuring that employers who disregard their obligations are held accountable while providing compliance assistance to the vast majority of employers who want to do right by their employees. Second, it will rescind or revise rules that exceed statutory authority, conflict with constitutional principles, or impose unnecessary costs. Third, where regulation is needed, the Department will proceed through notice-and-comment to provide transparency, solicit public input, and ensure that rules are grounded in sound economic and scientific data.

This balanced approach will protect workers, retirees, and job seekers while giving employers certainty and flexibility. The Department will continue to prioritize deregulatory actions that deliver meaningful cost savings, streamline compliance, and unleash innovation, while also moving forward with targeted rulemakings that secure retirement savings, ensure safe workplaces, and promote true equal opportunity. Through this plan, the Department of Labor is advancing the President's directives to unleash prosperity, restore merit, and put American workers first, ensuring that every regulatory action strengthens the economy, expands opportunity, and safeguards the rights and benefits of the American people.

The Department's Regulatory Priorities

The Employee Benefits Security Administration (EBSA) will propose a rule responsive to Executive Order 14330, Democratizing Access to Alternative Assets for 401(k) Investors, that will clarify the duties that a fiduciary owes to plan participants under ERISA when deciding whether to make available to plan participants an ( printed page 52885) asset allocation fund, including a fund that incorporates investments in alternative assets. Consistent with Executive Orders 13877, Improving Price and Quality Transparency in American Healthcare to Put Patients First, and 14273, Lowering Drug Prices by Once Again Putting Americans First, EBSA will work with the Departments of HHS and Treasury to propose rules designed to improve transparency and reduce costs in health care. EBSA also will propose a rule to reaffirm that fiduciaries under ERISA must base their investment decisions on financial considerations relevant to risk-adjusted economic value. This approach ensures that retirement plans are not diverted by political or social agendas, but instead remain focused on maximizing security for American retirees.

The Office of Federal Contract Compliance Programs (OFCCP), consistent with Executive Order 14173, Ending Illegal Discrimination and Restoring Merit-Based Opportunity, will issue a final rule based on its proposal to rescind regulations that pressured contractors to make employment decisions based on race, sex, or other similar classifications. These rules undermined equal employment opportunity by encouraging unlawful group preferences and perpetuating divisive DEI mandates. Their removal ensures that hiring and promotion in federal contracting is based on merit, not group identity. The Department is also removing other DEI-related rules across its programs, including regulations that imposed unlawful and unauthorized requirements on apprenticeship sponsors and grant recipients.

The Occupational Safety and Health Administration (OSHA) enforces a wide range of standards that are designed to reduce occupational deaths, injuries, and illnesses. OSHA is committed to establishing clear, common-sense standards to help accomplish this. OSHA will finalize the heat illness prevention standard first proposed in 2024, with a view toward avoiding excessive burdens that commenters identified. OSHA will also finalize a standard for emergency responders to ensure they are adequately protected while performing lifesaving duties. OSHA will also propose comprehensive safety rules for the tree care industry and to modernize the lockout/tagout standard to recognize new technologies that both improve safety and reduce costs, ensuring that regulatory requirements do not stand in the way of innovation.

The Wage and Hour Division (WHD) administers numerous laws that establish the minimum standards for wages and working conditions in the United States. WHD will issue a final rule based on a proposal to restore the statutory exemptions from minimum wage and overtime compensation requirements for home health workers, which, if finalized as proposed, could lower the cost of care for seniors and persons with disabilities. WHD has proposed and will finalize a rule that clarifies when a worker is an independent contractor under several of the laws it administers, which is intended to ensure that entrepreneurs and freelancers can work freely while businesses have legal certainty. Finally, WHD will also propose a rule to clarify joint employment under those laws, reducing litigation risk and encouraging job growth.

The Employment and Training Administration (ETA) oversees administration of federal job training and worker dislocation adjustment programs, federal grants to states for public employment service programs, unemployment insurance benefits, and foreign labor certifications. ETA will finalize the rescission of costly regulatory burdens on farmers who use the H-2A program while modernizing the methodology used to determine the adverse effect wage rate for the program. ETA proposed and will finalize reforms to the H-1B temporary nonimmigrant and permanent immigrant visa program to improve wage and employment protections for U.S. workers.

The Mine Safety and Health Administration (MSHA) is responsible for protecting the health and safety of the nation's miners. In 2026, MSHA will propose revisions to its respirable silica standard to address new developments in the mining industry and clarify existing requirements while maintaining strong protections for miners.

The Office of Labor-Management Standards (OLMS) promotes union democracy through standards for union officer elections and trusteeships over subordinate bodies. It also furthers financial integrity in labor unions and safeguards union assets, in part through reporting and disclosure requirements for labor unions and other entities. OLMS seeks to modernize the annual financial reports filed by labor organizations to ensure labor organizations are adhering to the highest standards of responsibility and ethical conduct.

Conclusion

The Trump Administration's 2026 DOL Regulatory Plan places America's workers first. By protecting retirement security, replacing divisive DEI requirements with meritocracy, and unleashing prosperity by reducing regulatory costs, the Department will strengthen America's workforce, increase opportunity, and ensure that every American worker has the chance to prosper.

DOL—Office of Federal Contract Compliance Programs (OFCCP)	Final Rule Stage

91. RESCISSION OF EXECUTIVE ORDER 11246 IMPLEMENTING REGULATIONS

Priority: Economically Significant. Major under 5 U.S.C. 801.

Regulatory Accounting: Deregulatory

Legal Authority: E.O. 14173

Relevant Executive Orders: 14192; 14173; 14219; 14267

CFR Citation: 41 CFR 60-1; 41 CFR 60-2; 41 CFR 60-3; 41 CFR 60-4; 41 CFR 60-20; 41 CFR 60-30; 41 CFR 60-40; 41 CFR 60-50; 41 CFR 60-999

Legal Deadline: None

Abstract: On January 21, 2025, President Trump issued Executive Order 14173, Ending Illegal Discrimination and Restoring Merit-Based Opportunity, which revoked Executive Order 11246, Equal Employment Opportunity. Accordingly, the United States Department of Labor is rescinding its regulations implementing Executive Order 11246 found at 41 CFR part 60-1 et seq.

Statement of Need: The rule will rescind the implementing regulations for E.O. 11246, which was revoked by E.O. 14173 on January 21, 2025. The rule will also address legal vulnerabilities related to the regulation's affirmative action requirements, improve the efficiency of the federal contracting process, decrease employer burden, and provide regulatory certainty to Federal contractors and other stakeholders by aligning the regulations with recent executive orders impacting DOL's enforcement.

Summary of Legal Basis: Under development

Alternatives: Under development

Anticipated Cost and Benefits: In the NPRM we estimated 10-year cost savings of $6,998,112,173 at a 7% discount rate. However, my understanding is ASP may add in additional cost savings in the final rule so this is still under development. Benefits include potential cost savings for covered contractors, removing unnecessary regulatory burdens, and reducing confusion about contractors' current regulatory obligations.

Risks: Under development

Timetable: ( printed page 52886)

Action	Date	FR Cite
NPRM	07/01/25	90 FR 28472
Comment Period Ends	09/02/25
NPRM Comment Period Extended	09/04/25	90 FR 42711
NPRM Comment Period Extended End	09/17/25
Final Rule	07/00/26

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Kenneth Wolfe, Director, Office of Federal Contract Compliance Programs, Department of Labor, Office of Federal Contract Compliance Programs, 200 Constitution Ave NE, Washington, DC 20002

Phone: 202 693-0101

Email: ofccp_guidance@dol.gov

RIN: 1250-AA17

DOL—Wage and Hour Division (WHD)	Proposed Rule Stage

92. EMPLOYEE OR INDEPENDENT CONTRACTOR STATUS UNDER THE FAIR LABOR STANDARDS ACT, FAMILY AND MEDICAL LEAVE ACT, AND MIGRANT AND SEASONAL AGRICULTURAL WORKER PROTECTION ACT

Priority: Economically Significant. Major under 5 U.S.C. 801.

Regulatory Accounting: Deregulatory

Legal Authority: 29 U.S.C. 201 et seq; 29 U.S.C. 1861; 29 U.S.C 2654

CFR Citation: 29 CFR 500.20(h)(4); 29 CFR part 795; 29 CFR 825.102

Legal Deadline: None

Abstract: In 2024, the Department of Labor (Department) published a final rule providing an analysis for determining employee or independent contractor classification under the Fair Labor Standards Act (FLSA). See 89 FR 1638 (2024 IC Rule). The 2024 IC Rule took effect on March 11, 2024. However, the 2024 IC Rule has been the subject of five separate legal challenges. In this rulemaking, the Department intends to rescind the 2024 IC rule and replace it with the analysis that the Department previously adopted in an earlier 2021 rule, with a few modifications. 91 FR 9932; see also 86 FR 1168 (2021 IC Rule). The Department has also proposed to modify regulations interpreting the Family and Medical Leave Act (FMLA) and Migrant and Seasonal Agricultural Worker Protection Act (MSPA) to clarify that the analysis for determining employee or independent contractor status under the FLSA also applies under the FMLA and MSPA.

Statement of Need: In 2024, the Department of Labor (Department) published a final rule providing an analysis for determining employee or independent contractor classification under the Fair Labor Standards Act (FLSA). See 89 FR 1638 (2024 IC Rule). The 2024 IC Rule took effect on March 11, 2024. However, the 2024 IC Rule has been the subject of five separate legal challenges. In this rulemaking, the Department has proposed to rescind the 2024 IC rule and replace it with the analysis that the Department previously adopted in an earlier 2021 rule, with a few modifications. 91 FR 9932; see also 86 FR 1168 (2021 IC Rule). the Department has also proposed to modify regulations interpreting the Family and Medical Leave Act (FMLA) and Migrant and Seasonal Agricultural Worker Protection Act (MSPA) to clarify that the analysis for determining employee or independent contractor status under the FLSA also applies under the FMLA and MSPA.

Summary of Legal Basis: The Department's authority to interpret the FLSA comes with its authority to administer and enforce it. See 29 U.S.C. 201-219. The Department's authority to interpret the FMLA and MSPA is delegated by statute. 29 U.S.C. 2654 (FMLA); 29 U.S.C. 1861 (MSPA).

Alternatives: The Department considered three alternatives to the proposed rule, listed below from least to most restrictive of independent contracting: (1) adoption of the common law control test, which applies in distinguishing between employees and independent contractors under various other federal laws; (2) adoption of the Wage and Hour Division's current enforcement policy, which is comprised of sub-regulatory guidance from before 2021 applying a multifactor economic reality balancing test; and (3) adoption of an ABC test (which a number of states have adopted).

Anticipated Cost and Benefits: The Department estimates that the proposed rule would impose an initial one-time regulatory familiarization cost of $488.2 million. However, the Department also estimates cost savings of $682.7 million per year attributable to increased clarity. Assuming that the proposed rule increases the number of independent contractors by 2 percent, the Department estimates benefits to workers from new labor force entry could amount to $17.6 billion over 10 years, with an additional $14.9 billion accruing to broader society in the form of taxes collected on the earnings of the new labor. On an annualized basis, the Department estimates that the benefits from increased labor force participation could amount to $3.25 billion per year at a 7 percent discount rate. See 91 FR 9962.

Risks: Under development

Timetable:

Action	Date	FR Cite
NPRM	02/27/26	91 FR 9932
NPRM Comment Period End	04/28/26
Final Rule	10/00/26

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Daniel Navarrete, Director, Division of Regulations, Legislation, and Interpretation (DRLI), Department of Labor, Wage and Hour Division, 200 Constitution Avenue NW, Room S-3502, Washington, DC 20210

Phone: 202 693-0406

Related RIN:

Related to 1235-AA43, Related to 1235-AA34

RIN: 1235-AA46

DOL—WHD

93. JOINT EMPLOYER STATUS UNDER THE FAIR LABOR STANDARDS ACT, FAMILY AND MEDICAL LEAVE ACT, AND MIGRANT AND SEASONAL AGRICULTURAL WORKER PROTECTION ACT

Priority: Economically Significant. Major under 5 U.S.C. 801.

Regulatory Accounting: Deregulatory

Legal Authority: 29 U.S.C. 201 et seq; 29 U.S.C. 1861; 29 U.S.C. 2654

CFR Citation: 29 CFR 500.20(h)(5); 29 CFR 791; 29 CFR 825.106; 29 CFR 780.305(c) and 780.331(d)

Legal Deadline: None

Abstract: Since 2021, the Department has had no generally-applicable regulatory guidance addressing joint employer liability under the Fair Labor Standards Act (FLSA). The Department is considering a notice of proposed rulemaking to provide interpretive guidance on FLSA joint employer liability at 29 CFR part 791 (where it was located prior to 2021), and also to amend provisions in the Department's regulations for the Family and Medical Leave Act (FMLA) and Migrant and Seasonal Agricultural Workers Protection Act (MSPA) to advise that joint employer status under those laws should be determined using the Department's FLSA analysis.

Statement of Need: Since 2021, the Department has had no generally- ( printed page 52887) applicable regulatory guidance addressing joint employer liability under the Fair Labor Standards Act (FLSA). The Department is considering a notice of proposed rulemaking to provide interpretive guidance on FLSA joint employer liability at 29 CFR part 791 (where it was located prior to 2021), and also to amend provisions in the Department's regulations for the Family and Medical Leave Act (FMLA) and Migrant and Seasonal Agricultural Workers Protection Act (MSPA) to advise that joint employer status under those laws should be determined using the Department's FLSA analysis.

Alternatives: Under development

Anticipated Cost and Benefits: Under development

Risks: Under development

Timetable:

Action	Date	FR Cite
NPRM	07/00/26

Regulatory Flexibility Analysis Required: No

Government Levels Affected: Undetermined

Phone: 202 693-0406

RIN: 1235-AA48

DOL—WHD	Final Rule Stage

94. • APPLICATION OF THE FAIR LABOR STANDARDS ACT TO DOMESTIC SERVICE

Priority: Economically Significant. Major under 5 U.S.C. 801.

Regulatory Accounting: Deregulatory

Legal Authority: 29 U.S.C. 213(a)(15); 29 U.S.C. 213(b)(21); Pub. L. 93-259, 29(b), 88 Stat. 76

CFR Citation: 29 CFR 552

Legal Deadline: None

Abstract: Section 13(a)(15) of the Fair Labor Standards Act (FLSA or the Act) provides an exemption from the Act's minimum wage and overtime pay requirements for domestic service employees engaged in providing companionship services for individuals who (because of age or infirmity) are unable to care for themselves. Section 13(b)(21) of the FLSA provides an exemption from the Act's overtime pay requirement for domestic service employees who reside in the household in which they provide services. In this rulemaking, the Department proposes to rescind a 2013 rule which, among other changes, precluded third-party employers from claiming either exemption and established limits on the amount of certain types of duties that exempt companions could perform. See 78 FR 60454 (Oct. 1, 2013).

Statement of Need: Section 13(a)(15) of the Fair Labor Standards Act (FLSA or the Act) provides an exemption from the Act's minimum wage and overtime pay requirements for domestic service employees engaged in providing companionship services for individuals who (because of age or infirmity) are unable to care for themselves. Section 13(b)(21) of the FLSA provides an exemption from the Act's overtime pay requirement for domestic service employees who reside in the household in which they provide services. In this rulemaking, the Department has proposed to rescind a 2013 rule which, among other changes, precluded third-party employers from claiming either exemption and established limits on the amount of certain types of duties that exempt companions could perform. 91 FR 28976; see also 78 FR 60454 (2013 rule).

Summary of Legal Basis: The exemptions at issue in this rulemaking were added to the FLSA by Congress in the 1974 FLSA Amendments, which included a broad grant of rulemaking authority empowering the Secretary of Labor to “prescribe necessary rules, regulations, and orders with regard to the amendments made by this Act.” 1974 Amendments, Public Law 93-259, 29(b), 88 Stat. 76. Additionally, the FLSA's sec. 13(a)(15) exemption for employees who provide companionship services provides that the scope of that exemption should be defined and delimited by regulations of the Secretary. 29 U.S.C. 213(a)(15).

Alternatives: The Department considered two alternatives in its proposed rule. First, the Department considered the alternative of preserving the status quo under the current regulations. Second, the Department considered the alternative of retaining some changes from the 2013 rule in lieu of a wholesale return to the pre-2013 regulations specifically, retaining all changes to the regulatory text in part 552 introduced by the 2013 rule except for the third party provision codified at 29 CFR 552.109 and limits on the provision of care codified in 29 CFR 552.6(b). This approach would, for example, keep the 2013 rule's updated definition of the job duties which constitute care and its removal of outdated domestic service worker examples like governesses, footmen, and grooms.

Anticipated Cost and Benefits: Anticipated costs for the final rule are under development. In its proposal, the Department discussed potential costs such as longer work hours and/or reduced pay for affected home care workers, lower morale for home care workers, increased worker turnover in the home care industry, added difficulty attracting workers to the home care industry, and modest rule familiarization costs. See90 FR 28982. Anticipated benefits for the final rule are also under development. In its proposal, the Department discussed potential benefits such as reduced labor costs for home care provider agencies, reduced costs for home care services for consumers, reduced Medicaid expenditures for the Federal government, expanded access to home care services, and reduced institutionalization of individuals who are in need of care. See 90 FR 28981-82.

Risks: Under development

Timetable:

Action	Date	FR Cite
NPRM	07/02/25	90 FR 28976
NPRM Comment Period End	09/03/25
Final Rule	11/00/26

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses, Governmental Jurisdictions, Organizations

Government Levels Affected: Federal, Local, State, Tribal

Phone: 202 693-0406

RIN: 1235-AA51

DOL—Employment and Training Administration (ETA)	Proposed Rule Stage

( printed page 52888)

95. • IMPROVING WAGE PROTECTIONS FOR THE TEMPORARY AND PERMANENT EMPLOYMENT OF CERTAIN FOREIGN NATIONS IN THE UNITED STATES

Priority: Economically Significant. Major under 5 U.S.C. 801.

Regulatory Accounting: Fully or Partially Exempt

Legal Authority: 8 U.S.C. 1182(a)(5)(A); 8 U.S.C. 1182(p) ; 8 U.S.C. 1182(n)(1)(A)(i)(I) and (II) ; 8 U.S.C. 1182(t)(1)(A)(i)(I) and (II) ; 8 U.S.C. 1101(a)(15)(H)(i)(b)

CFR Citation: 20 CFR 656.40 and 656.41; 20 CFR 655.731

Legal Deadline: None

Abstract: The Immigration and Nationality Act (8 U.S.C. 1101, et seq.) requires that for most employment-based immigrant admissions to the United States, the Secretary of Labor must first certify that the employment of the immigrant will not adversely affect the wages and working conditions of U.S. workers similarly employed and that U.S. workers are unavailable for the position. The Immigration and Nationality Act also requires that an individual may not be admitted into the United States on an H-1B nonimmigrant visa unless the employer attests that they will pay the individual the higher of the actual wage paid to other workers with similar experience or the prevailing wage in the area of employment. The Department of Labor's (Department) Employment and Training Administration is initiating rulemaking governing prevailing wages for employment opportunities that United States (U.S.) employers seek to fill with foreign workers on a permanent or temporary basis through certain employment-based immigrant visas and H-1B, H-1B1, or E-3 nonimmigrant visas. Specifically, in response to President Trump's proclamation, the Department is initiating a rulemaking to revise prevailing wage levels, in accordance with section 4(a) of the September 19, 2025, Presidential Proclamation, Restriction on Entry of Certain Nonimmigrant Workers, consistent with section 212(n) of the INA, 8 U.S.C. 1182(n). The proposed rule will amend the Departmental regulations governing permanent labor certifications and temporary labor condition applications (LCA) to incorporate changes to the computation of wage levels under the Department's four-tiered wage structure based on the Occupational Employment and Wage Statistics wage survey administered by the Bureau of Labor Statistics. The primary purpose of these changes is to update the computation of prevailing wage levels under the existing four-tiered wage structure to better reflect actual wages earned by similarly-employed U.S. workers. With this revision, the Department will be able to more effectively ensure under these programs that the employment of immigrant and nonimmigrant workers does not adversely affect wages for U.S. workers.

Statement of Need: On September 19, 2025, President Trump issued the Presidential Proclamation, Restriction on Entry of Certain Nonimmigrant Workers. Section 4(a) of the proclamation requires the Secretary of Labor shall initiate a rulemaking to revise the prevailing wage levels to levels consistent with the policy goals of this proclamation consistent with section 212(n) of the INA, 8 U.S.C. 1182(n). In response to the proclamation, the Department is initiating a rulemaking to revise the methodology used to compute prevailing wage levels. The proposed rule will amend the Departmental regulations governing permanent labor certifications and temporary labor condition applications to incorporate changes to the computation of wage levels under the Department's four-tiered wage structure based on the Occupational Employment and Wage Statistics wage survey administered by the Bureau of Labor Statistics. The primary purpose of these changes is to update the computation of prevailing wage levels under the existing four-tiered wage structure to better reflect actual wages earned by similarly-employed U.S. workers. With this revision, the Department will be able to more effectively ensure under these programs that the employment of immigrant and nonimmigrant workers does not adversely affect wages for U.S. workers.

Summary of Legal Basis: The Immigration and Nationality Act (INA) (8 U.S.C. 1101, et seq.) requires that for most employment-based immigrant admissions to the United States, the Secretary of Labor must first certify that the employment of the immigrant will not adversely affect the wages and working conditions of U.S. workers similarly employed and that U.S. workers are unavailable for the position. The Immigration and Nationality Act also requires that an individual may not be admitted into the United States on an H-1B nonimmigrant visa unless the employer attests that they will pay the individual the higher of the actual wage paid to other workers with similar experience or the prevailing wage in the area of employment. The Department of Labor's (Department) Employment and Training Administration is initiating rulemaking governing prevailing wages for employment opportunities that United States (U.S.) employers seek to fill with foreign workers on a permanent or temporary basis through certain employment-based immigrant visas and H-1B, H-1B1, or E-3 nonimmigrant visas. In accordance with the Presidential Proclamation, the Department will engage in rulemaking to ensure it is fulfilling its mandate under the INA.

Alternatives: The Presidential Proclamation directed the Secretary of Labor to engage in rulemaking, so no alternatives to rulemaking were considered.

Anticipated Cost and Benefits: The Department expects that the proposed rule will result in costs and transfer payments. The proposed rule will have an annualized cost of $3.37 million and a total 10-year cost of $23.66 million at a discount rate of 7 percent in 2024 dollars. The NPRM will result in annualized transfer payments (U.S. employers to other entities and individuals, including foreign workers) of up to $15.76 billion and total 10-year transfer payments of up to $110.66 billion at a discount rate of 7 percent in 2024 dollars.

One benefit of the NPRM 's increase in prevailing wages is the economic incentive to increase employee retention, training, and productivity which will increase benefits to both employers and U.S. workers. Strengthening prevailing wages will also help promote and protect jobs for U.S. workers. By ensuring that the employment of any foreign worker is commensurate with the wages paid to similarly employed U.S. workers, the Department will be protecting the types of white-collar, middle-class jobs that are critical to ensuring the economic viability of communities throughout the country. Finally, ensuring that skilled occupations are not performed at below-market wage rates by foreign workers will provide greater incentives for firms to expand education and job training programs. These programs can attract and develop the skills of a younger generation of U.S. workers to enter occupations that currently rely on elevated levels of foreign workers.

Risks: Under development

Timetable:

Action	Date	FR Cite
NPRM	03/27/26	91 FR 15454
NPRM Comment Period End	05/26/26

( printed page 52889)

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: Local, State

Agency Contact: Brian Pasternak, Administrator, Department of Labor, Employment and Training Administration, 200 Constitution Avenue NW, Office of Foreign Labor Certification; Room N-5311, FP Building, Washington, DC 20210

Phone: 202 693-8200

Email: oflc.regulations@dol.gov

RIN: 1205-AC30

DOL—ETA	Final Rule Stage

96. ADVERSE EFFECT WAGE RATE METHODOLOGY FOR THE TEMPORARY EMPLOYMENT OF H-2A NONIMMIGRANTS IN NON-RANGE OCCUPATIONS IN THE UNITED STATES

Priority: Economically Significant. Major under 5 U.S.C. 801.

Regulatory Accounting: Deregulatory

Legal Authority: 8 U.S.C. 1188

CFR Citation: 20 CFR 655, Subpart B

Legal Deadline: None

Abstract: The Department of Labor (DOL) amended its regulations governing the certification of agricultural labor or services to be performed by temporary foreign workers in H-2A nonimmigrant status (H-2A workers). Specifically, the Department amended its regulations to revise the methodology by which it determines the Adverse Effect Wage Rates (AEWRs) for non-range agricultural occupations through an Interim Final Rule issued October 2, 2025. DOL intends to issue a final rule after considering all of the comments received.

Statement of Need: Under development

Summary of Legal Basis: Under development

Alternatives: Under development

Anticipated Cost and Benefits: Under development

Risks: Under development

Timetable:

Action	Date	FR Cite
Interim Final Rule	10/02/25	90 FR 47914
Interim Final Rule Effective	10/02/25
Interim Final Rule Comment Period End	12/01/25
Final Rule	07/00/26

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: None

Phone: 202 693-8200

Email: oflc.regulations@dol.gov

RIN: 1205-AC24

DOL—ETA

97. RESCISSION OF FINAL RULE: IMPROVING PROTECTIONS FOR WORKERS IN TEMPORARY AGRICULTURAL EMPLOYMENT IN THE UNITED STATES

Priority: Other Significant. Major under 5 U.S.C. 801.

Regulatory Accounting: Deregulatory

Legal Authority: 8 U.S.C. 1188; 29 U.S.C. 49 et. seq.

CFR Citation: 20 CFR 655 Part B

Legal Deadline: None

Abstract: The Department of Labor (DOL) proposed to amend its regulations governing the certification of agricultural labor or services to be performed by temporary foreign workers in H-2A nonimmigrant status (H-2A workers) and enforcement of the contractual obligations applicable to employers of such nonimmigrant workers. The Notice of Proposed Rulemaking (NPRM) proposed rescinding provisions contained within a final rule published by the Department on April 29, 2024, which adopted a number of unnecessary, burdensome, and costly requirements on employers. The proposed regulatory changes may impact the regulations for the Employment Service and the H-2A non-immigrant visa program at 29 CFR part 501 and 20 CFR parts 651, 653, 654, 655, and 658.

Statement of Need: On April 29, 2024, the Department published a final rule entitled Improving Protections for Workers in Temporary Agricultural Employment in the United States, which adopted a number of unnecessary, burdensome, and costly requirements on employers. The 2024 Final Rule was the subject of four distinct legal challenges, two of which resulted in the Department being preliminarily enjoined from enforcing all or part of the 2024 Final Rule in certain States and for certain parties, and one of which resulted in a nationwide stay. On July 2, 2025, the Department proposed to rescind most requirements that were introduced by the 2024 Final Rule to ensure that the H-2A program's regulatory framework is a more reasonable balance between the statute's competing goals of providing an adequate labor supply and protecting the jobs of domestic agricultural workers.

Summary of Legal Basis: The Immigration and Nationality Act (INA), as amended by the Immigration Reform and Control Act of 1986 (IRCA), establishes an H-2A nonimmigrant visa classification for a worker having a residence in a foreign country which he has no intention of abandoning who is coming temporarily to the United States to perform agricultural labor or services . . . of a temporary or seasonal nature. 8 U.S.C. 1101(a)(15)(H)(ii)(a); see also 8 U.S.C. 1184(c)(1) and 1188. Agricultural labor or services includes the types of labor and services defined by the Secretary of Labor in regulations, as well as the Internal Revenue Code definition of agricultural labor at section 3121(g) of title 26, the Fair Labor Standards Act definition of agriculture at section 203(f) of title 29, and the pressing of apples for cider on a farm . . . . 8 U.S.C. 1101(a)(15)(H)(ii)(a). The Secretary of Labor has delegated the authority to issue temporary agricultural labor certifications to the Assistant Secretary for Employment and Training, who in turn has delegated that authority to ETA's Office of Foreign Labor Certification (OFLC). In addition, the Secretary has delegated to the Department's Wage and Hour Division (WHD) the responsibility under sec. 218(g)(2) of the INA, 8 U.S.C. 1188(g)(2), to assure employer compliance with the terms and conditions of employment under the H-2A program.

Alternatives: In its NPRM, the Department considered two alternatives to this proposal. First, the Department considered preserving the current regulations at 20 CFR parts 651, 653, 655, and 658, and 29 CFR part 501, as modified by the 2024 H-2A Final Rule, until litigation is resolved. Second, the Department considered reverting back to the regulations in 20 CFR parts 651, 653, 655, and 658, and 29 CFR part 501, as of June 27, 2024. This option would remove all changes effectuated by the 2024 H-2A Final Rule, regardless of their utility.

Anticipated Cost and Benefits: Anticipated costs and benefits for this final rule are under development. In its proposal, the Department estimated total quantifiable annualized net cost savings from the rescissions in this proposed rule as $1.02 million and the annualized transfer payments (from employees to H-2A employers) at $12.66 million, each at a discount rate of 7 percent over a 10-year analysis period. ( printed page 52890)

Risks: Under development

Timetable:

Action	Date	FR Cite
NPRM	07/02/25	90 FR 28919
NPRM Comment Period End	09/02/25
Final Rule	07/00/26

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Kimberly Vitelli, Administrator, Office of Workforce Investment, Department of Labor, Employment and Training Administration 200 Constitution Avenue NW FP Building, Room C-4526 Washington, DC 20210

Phone: 202 693-3980

Email: vitelli.kimberly@dol.gov

Daniel Navarrete, Director, Department of Labor, Wage and Hour Division, 200 Constitution Ave. NW, Suite S-3016, Washington, DC 20210

Phone: 202 693-1134