Office of Information and Regulatory Affairs (OIRA)

Executive Order Submissions Under Review

June 11, 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-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-AD39	Status: Pending Review
TITLE:Reducing Bureaucracy and Burden for Child Support Enforcement
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: 05/05/2026	LEGAL DEADLINE: None
AGENCY: HHS-ACF	RIN: 0970-AD30	Status: Pending Review
TITLE:Modernize the Head Start Program by Reducing Requirements and Enhancing Alignment with State and Local Systems
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: 05/22/2026	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: 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: 05/29/2026	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-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-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-CMS	RIN: 0938-AW03	Status: Pending Review
TITLE:Exchange Pre-Enrollment Eligibility Verification (CMS-9873)
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: 04/22/2026	LEGAL DEADLINE: None
AGENCY: HHS-CMS	RIN: 0938-AV81	Status: Pending Review
TITLE:CY 2027 Changes to the End-Stage Renal Disease (ESRD) Prospective Payment System and Quality Incentive Program (CMS-1846)
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: 04/22/2026	LEGAL DEADLINE: Statutory
AGENCY: HHS-CMS	RIN: 0938-AV80	Status: Pending Review
TITLE:CY 2027 Home Health Prospective Payment System Rate Update and Home Infusion Therapy Services Payment Update (CMS-1844)
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: 05/11/2026	LEGAL DEADLINE: Statutory
AGENCY: HHS-CMS	RIN: 0938-AV70	Status: Pending Review
TITLE:Strengthening the Integrity of Medicaid and CHIP Managed Care, Financing, and Access to Care (CMS-2450)
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: 05/12/2026	LEGAL DEADLINE: None
AGENCY: HHS-CMS	RIN: 0938-AV92	Status: Pending Review
TITLE:Short-Term, Limited-Duration Insurance (CMS-9881)
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: 05/30/2026	LEGAL DEADLINE: None
AGENCY: HHS-CMS	RIN: 0938-AW09	Status: Pending Review
TITLE:Request for Information: Pharmacy Benefit Manager Compensation and Data Collection (CMS-4218)
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: 06/01/2026	LEGAL DEADLINE: None
AGENCY: HHS-CMS	RIN: 0938-AW01	Status: Pending Review
TITLE:Request for Information; Clinical Laboratory Improvement Amendments (CLIA) of 1988 Regulations (CMS-3485)
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: 06/01/2026	LEGAL DEADLINE: None
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-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-FDA	RIN: 0910-AI72	Status: Pending Review
TITLE:Use of Salt Substitutes to Reduce the Sodium Content in Standardized Foods
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: 04/20/2026	LEGAL DEADLINE: None
AGENCY: HHS-FDA	RIN: 0910-ZC90	Status: Pending Review
TITLE:Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products; Revised 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: 04/24/2026	LEGAL DEADLINE: None
AGENCY: HHS-FDA	RIN: 0910-AI98	Status: Pending Review
TITLE:Food Standards of Identity Modernization; Pasteurized Orange Juice
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: 05/08/2026	LEGAL DEADLINE: None
AGENCY: HHS-FDA	RIN: 0910-ZD09	Status: Pending Review
TITLE:Action Levels for Cadmium in Processed Food Intended for Babies and Young Children; 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: 05/22/2026	LEGAL DEADLINE: None
AGENCY: HHS-FDA	RIN: 0910-ZD12	Status: Pending Review
TITLE:Biosimilar and Interchangeable Biosimilar Products: Considerations for Container Closure Systems and Device Constituent Parts; 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: 05/27/2026	LEGAL DEADLINE: None
AGENCY: HHS-FDA	RIN: 0910-ZD15	Status: Pending Review
TITLE:Requirements for Additional Traceability Records for Certain Foods: Enforcement Policy for Certain Retail Food Establishments and Restaurants
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: 06/01/2026	LEGAL DEADLINE: None
AGENCY: HHS-FDA	RIN: 0910-ZD23	Status: Pending Review
TITLE:New Dietary Ingredient (NDI) Notifications and Related Issues; Identity and Safety Information About the NDI: 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: 06/02/2026	LEGAL DEADLINE: None
AGENCY: HHS-FDA	RIN: 0910-ZD25	Status: Pending Review
TITLE:Expedited Investigational New Drug Pilot Program; Request for Information
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: 06/03/2026	LEGAL DEADLINE: None
AGENCY: HHS-FDA	RIN: 0910-AJ03	Status: Pending Review
TITLE:Requirements For Additional Traceability Records For Certain Foods: Compliance Date Extension
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: 06/03/2026	LEGAL DEADLINE: None
AGENCY: HHS-FDA	RIN: 0910-AI91	Status: Pending Review
TITLE:Rulemaking to Provide by Regulation that an Ingredient Is Not Excluded From the Dietary Supplement Definition
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: 06/05/2026	LEGAL DEADLINE: None
AGENCY: HHS-HRSA	RIN: 0906-ZA23	Status: Pending Review
TITLE:Notice Regarding 340B Rebate Model Pilot Program
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: 05/27/2026	LEGAL DEADLINE: None
AGENCY: HHS-NIH	RIN: 0925-ZA10	Status: Pending Review
TITLE:Request for Information on Measuring and Rewarding Scientific Impact
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: 06/08/2026	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-AA29	Status: Pending Review
TITLE:Rescinding Portions of Department of Health and Human Services Title VI Regulations to Conform More Closely with the Statutory Text and to Implement Executive Order 14281
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: 04/24/2026	LEGAL DEADLINE: None
AGENCY: HHS-OCR	RIN: 0945-AA31	Status: Pending Review
TITLE:Rescinding Guidelines for Eliminating Discrimination and Denial of Services on the Basis of Race, Color, National Origin, Sex, and Handicap in Vocational Education Programs
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: 06/04/2026	LEGAL DEADLINE: None