Office of Information and Regulatory Affairs (OIRA)

Executive Order Submissions Under Review

March 03, 2026

---

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-AD18	Status: Pending Review
TITLE:Employment and Training Services for Noncustodial Parents in the Child Support Program Final Rule; Rescission
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: 12/19/2025	LEGAL DEADLINE: None
AGENCY: HHS-ACF	RIN: 0970-AD19	Status: Pending Review
TITLE:Designated Placements Requirements Under Titles IV-E and IV-B for LQBTQ+ Children; Rescission
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: 01/20/2026	LEGAL DEADLINE: None
AGENCY: HHS-ACF	RIN: 0970-AD34	Status: Pending Review
TITLE:Unaccompanied Alien Children Program Foundational Rule; Updates to Accord with the Hyde Amendment
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: 01/23/2026	LEGAL DEADLINE: None
AGENCY: HHS-CMS	RIN: 0938-AV93	Status: Pending Review
TITLE:Amending the Indirect Hold Harmless Threshold of Health Care-Related Taxes (CMS-2452)
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: 12/31/2025	LEGAL DEADLINE: Statutory
AGENCY: HHS-CMS	RIN: 0938-AT38	Status: Pending Review
TITLE:Administrative Simplification: Adoption of Standards for Health Care Attachment Transactions and Electronic Signatures (CMS-0053)
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: 01/09/2026	LEGAL DEADLINE: None
AGENCY: HHS-CMS	RIN: 0938-AV44	Status: Pending Review
TITLE:Interoperability Standards and Prior Authorization for Drugs (CMS-0062)
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: 01/16/2026	LEGAL DEADLINE: None
AGENCY: HHS-CMS	RIN: 0938-AV79	Status: Pending Review
TITLE:Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals; the Long-Term Care Hospital Prospective Payment System; and FY 2027 Rates (CMS-1849)
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: 01/22/2026	LEGAL DEADLINE: Statutory
AGENCY: HHS-CMS	RIN: 0938-AV15	Status: Pending Review
TITLE:Independent Dispute Resolution Operations (CMS-9897)
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: 01/29/2026	LEGAL DEADLINE: None
AGENCY: HHS-CMS	RIN: 0938-AU88	Status: Pending Review
TITLE:Strengthening Oversight of Accrediting Organizations (AO), Burden Reduction, and Related Provisions (CMS-3367)
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. No
RECEIVED DATE: 02/04/2026	LEGAL DEADLINE: Statutory
AGENCY: HHS-CMS	RIN: 0938-AV63	Status: Pending Review
TITLE:Contract Year 2027 Policy and Technical Changes to Medicare Advantage, Medicare Prescription Drug Benefit, Medicare Cost Plan, and Programs of All-Inclusive Care for the Elderly Programs (CMS-4212)
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. No
RECEIVED DATE: 02/18/2026	LEGAL DEADLINE: Statutory
AGENCY: HHS-CMS	RIN: 0938-AV77	Status: Pending Review
TITLE:FY 2027 Inpatient Psychiatric Facilities Prospective Payment System Rate and Quality Reporting Updates (CMS-1847)
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: 02/25/2026	LEGAL DEADLINE: Statutory
AGENCY: HHS-CMS	RIN: 0938-AV78	Status: Pending Review
TITLE:FY 2027 Hospice Wage Index, Payment Rate Update, and Quality Reporting Requirements (CMS-1851)
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: 02/26/2026	LEGAL DEADLINE: Statutory
AGENCY: HHS-CMS	RIN: 0938-AV90	Status: Pending Review
TITLE:Medicare Drug Price Negotiation Program (CMS-4215)
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: 02/26/2026	LEGAL DEADLINE: None
AGENCY: HHS-CMS	RIN: 0938-AV76	Status: Pending Review
TITLE:FY 2027 Inpatient Rehabilitation Facility (IRF) Prospective Payment System Rate Update and Quality Reporting Program (CMS-1845)
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: 02/26/2026	LEGAL DEADLINE: Statutory
AGENCY: HHS-CMS	RIN: 0938-AV69	Status: Pending Review
TITLE:Medicaid Managed Care State Directed Payments and Medicaid Fee-For-Service Targeted Medicaid Practitioner Payments (CMS-2449)
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: 02/27/2026	LEGAL DEADLINE: None
AGENCY: HHS-CMS	RIN: 0938-AV75	Status: Pending Review
TITLE:FY 2027 Skilled Nursing Facility (SNFs) Prospective Payment System and Consolidated Billing and Updates to the Value-Based Purchasing and Quality Reporting Programs (CMS-1843)
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: 02/27/2026	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-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-ZC71	Status: Pending Review
TITLE:Medical Devices with Indications Associated with Weight Loss--Premarket Considerations; 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: 12/18/2025	LEGAL DEADLINE: None
AGENCY: HHS-FDA	RIN: 0910-ZC72	Status: Pending Review
TITLE:General Considerations for the Use of New Approach Methodologies; 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: 01/09/2026	LEGAL DEADLINE: None
AGENCY: HHS-FDA	RIN: 0910-ZC73	Status: Pending Review
TITLE:Responding to FDA Form 483 Observations at the Conclusion of a Drug CGMP Inspection: 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: 01/27/2026	LEGAL DEADLINE: None
AGENCY: HHS-FDA	RIN: 0910-ZC78	Status: Pending Review
TITLE:Statement of Policy – Considerations for Flavored Electronic Nicotine Delivery Systems (ENDS) Premarket Applications; Draft 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: 02/18/2026	LEGAL DEADLINE: None
AGENCY: HHS-FDA	RIN: 0910-AH59	Status: Pending Review
TITLE:Establishment Registration and Product Listing for Tobacco Products
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: 02/19/2026	LEGAL DEADLINE: None