Office of Information and Regulatory Affairs (OIRA)

Executive Order Submissions Under Review

December 13, 2025

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Department of Health and Human Services

AGENCY: HHS-ACF	RIN: 0970-ZA23	Status: Pending Review
TITLE:Publish Request for Information: Nutrition Services in Head Start Programs
STAGE: Notice	Economically Significant: This term refers to a regulatory action, as determined under Section 3(f)(1) of E.O. 12866, that will have an annual effect on the economy of $100 million or more or will 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, or tribal governments or communities. No
RECEIVED DATE: 07/17/2025	LEGAL DEADLINE: None
AGENCY: HHS-ACF	RIN: 0970-AD07	Status: Pending Review
TITLE:Temporary Assistance for Needy Families Work Participation Rate Calculation Changes
STAGE: Proposed Rule	Economically Significant: This term refers to a regulatory action, as determined under Section 3(f)(1) of E.O. 12866, that will have an annual effect on the economy of $100 million or more or will 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, or tribal governments or communities. No
RECEIVED DATE: 08/27/2025	LEGAL DEADLINE: None
AGENCY: HHS-ACF	RIN: 0970-AD26	Status: Pending Review
TITLE:Unaccompanied Children Program Foundational Rule; Update to Include Proof of Identity and Income Verification Standards
STAGE: Interim Final Rule	Economically Significant: This term refers to a regulatory action, as determined under Section 3(f)(1) of E.O. 12866, that will have an annual effect on the economy of $100 million or more or will 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, or tribal governments or communities. No
RECEIVED DATE: 09/19/2025	LEGAL DEADLINE: None
AGENCY: HHS-ACF	RIN: 0970-AD20	Status: Pending Review
TITLE:Restoring Flexibility to the Child Care and Development Fund (CCDF)
STAGE: Proposed Rule	Economically Significant: This term refers to a regulatory action, as determined under Section 3(f)(1) of E.O. 12866, that will have an annual effect on the economy of $100 million or more or will 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, or tribal governments or communities. No
RECEIVED DATE: 09/24/2025	LEGAL DEADLINE: None
AGENCY: HHS-CMS	RIN: 0938-AV73	Status: Pending Review
TITLE:Medicaid Program; Prohibition on Federal Medicaid Funding for Sex Trait Modification Procedures Furnished to Children and Youth (CMS-2451)
STAGE: Proposed Rule	Economically Significant: This term refers to a regulatory action, as determined under Section 3(f)(1) of E.O. 12866, that will have an annual effect on the economy of $100 million or more or will 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, or tribal governments or communities. No
RECEIVED DATE: 07/18/2025	LEGAL DEADLINE: None
AGENCY: HHS-CMS	RIN: 0938-AV87	Status: Pending Review
TITLE:Medicare and Medicaid Programs; Hospital Condition of Participation: Limiting Participation Based on the Performance of Sex Trait Modification Procedures on Children.
STAGE: Proposed Rule	Economically Significant: This term refers to a regulatory action, as determined under Section 3(f)(1) of E.O. 12866, that will have an annual effect on the economy of $100 million or more or will 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, or tribal governments or communities. No
RECEIVED DATE: 08/07/2025	LEGAL DEADLINE: None
AGENCY: HHS-CMS	RIN: 0938-AV64	Status: Pending Review
TITLE:Transparency in Coverage (CMS-9882)
STAGE: Proposed Rule	Economically Significant: This term refers to a regulatory action, as determined under Section 3(f)(1) of E.O. 12866, that will have an annual effect on the economy of $100 million or more or will 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, or tribal governments or communities. No
RECEIVED DATE: 08/20/2025	LEGAL DEADLINE: None
AGENCY: HHS-CMS	RIN: 0938-AU54	Status: Pending Review
TITLE:Amendments to Rules Governing Organ Procurement Organizations (CMS-3409)
STAGE: Proposed Rule	Economically Significant: This term refers to a regulatory action, as determined under Section 3(f)(1) of E.O. 12866, that will have an annual effect on the economy of $100 million or more or will 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, or tribal governments or communities. No
RECEIVED DATE: 08/21/2025	LEGAL DEADLINE: None
AGENCY: HHS-CMS	RIN: 0938-AV72	Status: Pending Review
TITLE:Ensuring Safety through Domestic Security with Made in America Personal Protective Equipment (PPE) and Essential Medicine Procurement by Medicare Providers and Suppliers (CMS-1516)
STAGE: Prerule	Economically Significant: This term refers to a regulatory action, as determined under Section 3(f)(1) of E.O. 12866, that will have an annual effect on the economy of $100 million or more or will 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, or tribal governments or communities. No
RECEIVED DATE: 09/12/2025	LEGAL DEADLINE: None
AGENCY: HHS-CMS	RIN: 0938-AV66	Status: Pending Review
TITLE:Global Benchmark for Efficient Drug Pricing (GLOBE) Model (CMS-5545)
STAGE: Proposed Rule	Economically Significant: This term refers to a regulatory action, as determined under Section 3(f)(1) of E.O. 12866, that will have an annual effect on the economy of $100 million or more or will 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, or tribal governments or communities. Yes
RECEIVED DATE: 09/25/2025	LEGAL DEADLINE: None
AGENCY: HHS-CMS	RIN: 0938-AV74	Status: Pending Review
TITLE:Guarding U.S. Medicare Against Rising Drug Costs (GUARD) Model (CMS-5546)
STAGE: Proposed Rule	Economically Significant: This term refers to a regulatory action, as determined under Section 3(f)(1) of E.O. 12866, that will have an annual effect on the economy of $100 million or more or will 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, or tribal governments or communities. Yes
RECEIVED DATE: 10/02/2025	LEGAL DEADLINE: None
AGENCY: HHS-CMS	RIN: 0938-AV62	Status: Pending Review
TITLE:HHS Notice of Benefit and Payment Parameters for 2027 (CMS-9883)
STAGE: Proposed Rule	Economically Significant: This term refers to a regulatory action, as determined under Section 3(f)(1) of E.O. 12866, that will have an annual effect on the economy of $100 million or more or will 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, or tribal governments or communities. Yes
RECEIVED DATE: 11/14/2025	LEGAL DEADLINE: None
AGENCY: HHS-CMS	RIN: 0938-AV58	Status: Pending Review
TITLE:Preserving Medicaid Funding for Vulnerable Populations – Closing a Health Care-Related Tax Loophole (CMS-2448)
STAGE: Final Rule	Economically Significant: This term refers to a regulatory action, as determined under Section 3(f)(1) of E.O. 12866, that will have an annual effect on the economy of $100 million or more or will 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, or tribal governments or communities. Yes
RECEIVED DATE: 11/17/2025	LEGAL DEADLINE: None
AGENCY: HHS-CMS	RIN: 0938-ZC01	Status: Pending Review
TITLE:Advance Notice of Methodological Changes for Calendar Year (CY) 2027 for Medicare Advantage (MA) Capitation Rates and Part C and Part D Payment Policies
STAGE: Notice	Economically Significant: This term refers to a regulatory action, as determined under Section 3(f)(1) of E.O. 12866, that will have an annual effect on the economy of $100 million or more or will 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, or tribal governments or communities. Yes
RECEIVED DATE: 12/04/2025	LEGAL DEADLINE: Statutory
AGENCY: HHS-FDA	RIN: 0910-ZC37	Status: Pending Review
TITLE:Evaluating the Safety of Antimicrobial New Animal Drugs with Regard to their Microbiological Effects on Bacteria of Human Health Concern; Guidance for Industry
STAGE: Notice	Economically Significant: This term refers to a regulatory action, as determined under Section 3(f)(1) of E.O. 12866, that will have an annual effect on the economy of $100 million or more or will 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, or tribal governments or communities. No
RECEIVED DATE: 07/10/2025	LEGAL DEADLINE: None
AGENCY: HHS-FDA	RIN: 0910-ZC45	Status: Pending Review
TITLE:Postapproval Pregnancy Safety Studies; Guidance for Industry; Availability
STAGE: Notice	Economically Significant: This term refers to a regulatory action, as determined under Section 3(f)(1) of E.O. 12866, that will have an annual effect on the economy of $100 million or more or will 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, or tribal governments or communities. No
RECEIVED DATE: 08/21/2025	LEGAL DEADLINE: None
AGENCY: HHS-FDA	RIN: 0910-ZC55	Status: Pending Review
TITLE:Use of Real-World Evidence To Support Regulatory Decision-Making for Medical Devices; Guidance for Industry and Food and Drug Administration Staff; Availability
STAGE: Notice	Economically Significant: This term refers to a regulatory action, as determined under Section 3(f)(1) of E.O. 12866, that will have an annual effect on the economy of $100 million or more or will 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, or tribal governments or communities. No
RECEIVED DATE: 09/09/2025	LEGAL DEADLINE: None
AGENCY: HHS-FDA	RIN: 0910-ZC59	Status: Pending Review
TITLE:Defining Durations of Use for Approved Medically Important Antimicrobial Drugs Fed to Food-Producing Animals; Guidance for Industry (final guidance)
STAGE: Notice	Economically Significant: This term refers to a regulatory action, as determined under Section 3(f)(1) of E.O. 12866, that will have an annual effect on the economy of $100 million or more or will 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, or tribal governments or communities. No
RECEIVED DATE: 09/12/2025	LEGAL DEADLINE: None
AGENCY: HHS-FDA	RIN: 0910-ZC67	Status: Pending Review
TITLE:New and Revised Draft Q&As on Biosimilar Development and the Biologics Price Competition and Innovation Act; Draft Guidance for Industry; Availability
STAGE: Notice	Economically Significant: This term refers to a regulatory action, as determined under Section 3(f)(1) of E.O. 12866, that will have an annual effect on the economy of $100 million or more or will 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, or tribal governments or communities. No
RECEIVED DATE: 11/26/2025	LEGAL DEADLINE: None
AGENCY: HHS-FDA	RIN: 0910-ZC68	Status: Pending Review
TITLE:New Clinical Investigation Exclusivity (3-Year Exclusivity) for Drug Products: Questions and Answers; Draft Guidance for Industry; Availability
STAGE: Notice	Economically Significant: This term refers to a regulatory action, as determined under Section 3(f)(1) of E.O. 12866, that will have an annual effect on the economy of $100 million or more or will 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, or tribal governments or communities. No
RECEIVED DATE: 12/01/2025	LEGAL DEADLINE: None
AGENCY: HHS-FDA	RIN: 0910-AJ02	Status: Pending Review
TITLE:Substances Generally Recognized as Safe
STAGE: Proposed Rule	Economically Significant: This term refers to a regulatory action, as determined under Section 3(f)(1) of E.O. 12866, that will have an annual effect on the economy of $100 million or more or will 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, or tribal governments or communities. No
RECEIVED DATE: 12/01/2025	LEGAL DEADLINE: None
AGENCY: HHS-FDA	RIN: 0910-ZC69	Status: Pending Review
TITLE:Minimal Residual Disease and Complete Response in Multiple Myeloma: Use as Endpoints to Support Accelerated Approval
STAGE: Notice	Economically Significant: This term refers to a regulatory action, as determined under Section 3(f)(1) of E.O. 12866, that will have an annual effect on the economy of $100 million or more or will 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, or tribal governments or communities. No
RECEIVED DATE: 12/05/2025	LEGAL DEADLINE: None
AGENCY: HHS-OCR	RIN: 0945-AA27	Status: Pending Review
TITLE:Clarifying Statutory Limitation on Disability as it Applies to Gender Identity and Dysphoria in Nondiscrimination in Programs and Activities Receiving Federal Financial Assistance
STAGE: Proposed Rule	Economically Significant: This term refers to a regulatory action, as determined under Section 3(f)(1) of E.O. 12866, that will have an annual effect on the economy of $100 million or more or will 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, or tribal governments or communities. No
RECEIVED DATE: 11/24/2025	LEGAL DEADLINE: None
AGENCY: HHS-ASTP/ONC	RIN: 0955-AA09	Status: Pending Review
TITLE:Health Data, Technology, and Interoperability: ASTP/ONC Deregulatory Actions to Unleash Prosperity
STAGE: Proposed Rule	Economically Significant: This term refers to a regulatory action, as determined under Section 3(f)(1) of E.O. 12866, that will have an annual effect on the economy of $100 million or more or will 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, or tribal governments or communities. Yes
RECEIVED DATE: 09/24/2025	LEGAL DEADLINE: None