Office of Information and Regulatory Affairs (OIRA)

Executive Order Submissions Under Review

April 21, 2026

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Department of Health and Human Services

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-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-ACF	RIN: 0970-AD21	Status: Pending Review
TITLE:Restoring Flexibility to Support Head Start Program Access
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: 03/03/2026	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-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-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-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-AV98	Status: Pending Review
TITLE:Establishing State Community Engagement Requirements for Certain Individuals Under Section 1902(xx) of the Social Security Act (CMS-2454)
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. Yes
RECEIVED DATE: 03/31/2026	LEGAL DEADLINE: Statutory
AGENCY: HHS-CMS	RIN: 0938-AV62	Status: Pending Review
TITLE:Patient Protection and Affordable Care Act, HHS Notice of Benefit and Payment Parameters for 2027; and Basic Health Program (CMS-9883)
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: 04/01/2026	LEGAL DEADLINE: None
AGENCY: HHS-CMS	RIN: 0938-AV65	Status: Pending Review
TITLE:Alternative Payment Model Updates and the Increasing Organ Transplant Access (IOTA) Model (CMS-5544)
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: 04/11/2026	LEGAL DEADLINE: Statutory
AGENCY: HHS-CMS	RIN: 0938-AV83	Status: Pending Review
TITLE:CY 2027 Hospital Outpatient PPS Policy Changes and Payment Rates and Ambulatory Surgical Center Payment System Policy Changes and Payment Rates (CMS-1850)
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: 04/13/2026	LEGAL DEADLINE: Statutory
AGENCY: HHS-CMS	RIN: 0938-AV82	Status: Pending Review
TITLE:CY 2027 Revisions to Payment Policies under the Physician Fee Schedule and Other Revisions to Medicare Part B (CMS-1848)
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: 04/14/2026	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-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
AGENCY: HHS-FDA	RIN: 0910-AI94	Status: Pending Review
TITLE:Drug Establishment Registration and Drug Listing Requirements for Establishments Engaged in Distributed Manufacturing and Certain Foreign Establishments
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: 03/04/2026	LEGAL DEADLINE: Statutory
AGENCY: HHS-FDA	RIN: 0910-ZC82	Status: Pending Review
TITLE:Cannabidiol (CBD) Products Compliance and Enforcement Policy
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: 03/13/2026	LEGAL DEADLINE: None
AGENCY: HHS-FDA	RIN: 0910-ZC89	Status: Pending Review
TITLE:Serotonin-2A Agonists and Related Products: Considerations for Clinical Investigations; 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: 04/17/2026	LEGAL DEADLINE: None
AGENCY: HHS-OCR	RIN: 0945-AA00	Status: Pending Review
TITLE:HIPAA Privacy Rule: Changes to Support Coordinated Care and Individual Engagement and Reduce Regulatory Burdens
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: 04/02/2026	LEGAL DEADLINE: None
AGENCY: HHS-OCR	RIN: 0945-AA30	Status: Pending Review
TITLE:Nondiscrimination on the Basis of Disability by Recipients of Department of Health and Human Services Financial Assistance
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. Yes
RECEIVED DATE: 04/17/2026	LEGAL DEADLINE: None