List of Regulatory Actions Currently Under Review

(Agency: HHS; Rule Stage: ALL; Length of Review: ALL; Economically Significant: ALL; International Impact: ALL)


Department of Health and Human Services
AGENCY: HHS-ACF RIN: 0970-AD34 Status: Pending Review for rule 0970-AD34 Request EO Meeting for rule 0970-AD34
TITLE: Unaccompanied Alien Children Program Foundational Rule; Updates to Accord with the Hyde Amendment
STAGE: Proposed Rule ECONOMICALLY SIGNIFICANT: No
RECEIVED DATE: 01/23/2026 LEGAL DEADLINE: None  


AGENCY: HHS-ACF RIN: 0970-AD30 Status: Pending Review for rule 0970-AD30 Request EO Meeting for rule 0970-AD30
TITLE: Modernize the Head Start Program by Reducing Requirements and Enhancing Alignment with State and Local Systems
STAGE: Proposed Rule ECONOMICALLY SIGNIFICANT: Yes
RECEIVED DATE: 05/22/2026 LEGAL DEADLINE: None  


AGENCY: HHS-ACF RIN: 0970-AD19 Status: Pending Review for rule 0970-AD19 Request EO Meeting for rule 0970-AD19
TITLE: Designated Placements Requirements Under Titles IV-E and IV-B for LQBTQ+ Children; Rescission
STAGE: Final Rule ECONOMICALLY SIGNIFICANT: No
RECEIVED DATE: 05/29/2026 LEGAL DEADLINE: None  


AGENCY: HHS-CMS RIN: 0938-AV83 Status: Pending Review for rule 0938-AV83 Request EO Meeting for rule 0938-AV83
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: Yes
RECEIVED DATE: 04/13/2026 LEGAL DEADLINE: Statutory  


AGENCY: HHS-CMS RIN: 0938-AV82 Status: Pending Review for rule 0938-AV82 Request EO Meeting for rule 0938-AV82
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: Yes
RECEIVED DATE: 04/14/2026 LEGAL DEADLINE: Statutory  


AGENCY: HHS-CMS RIN: 0938-AV81 Status: Pending Review for rule 0938-AV81 Request EO Meeting for rule 0938-AV81
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: Yes
RECEIVED DATE: 04/22/2026 LEGAL DEADLINE: Statutory  


AGENCY: HHS-CMS RIN: 0938-AW03 Status: Pending Review for rule 0938-AW03 Request EO Meeting for rule 0938-AW03
TITLE: Exchange Pre-Enrollment Eligibility Verification (CMS-9873)
STAGE: Proposed Rule ECONOMICALLY SIGNIFICANT: Yes
RECEIVED DATE: 04/22/2026 LEGAL DEADLINE: None  


AGENCY: HHS-CMS RIN: 0938-AV80 Status: Pending Review for rule 0938-AV80 Request EO Meeting for rule 0938-AV80
TITLE: CY 2027 Home Health Prospective Payment System Rate Update and Home Infusion Therapy Services Payment Update (CMS-1844)
STAGE: Proposed Rule ECONOMICALLY SIGNIFICANT: Yes
RECEIVED DATE: 05/11/2026 LEGAL DEADLINE: Statutory  


AGENCY: HHS-CMS RIN: 0938-AV70 Status: Pending Review for rule 0938-AV70 Request EO Meeting for rule 0938-AV70
TITLE: Strengthening the Integrity of Medicaid and CHIP Managed Care, Financing, and Access to Care (CMS-2450)
STAGE: Proposed Rule ECONOMICALLY SIGNIFICANT: Yes
RECEIVED DATE: 05/12/2026 LEGAL DEADLINE: None  


AGENCY: HHS-CMS RIN: 0938-AV92 Status: Pending Review for rule 0938-AV92 Request EO Meeting for rule 0938-AV92
TITLE: Short-Term, Limited-Duration Insurance (CMS-9881)
STAGE: Proposed Rule ECONOMICALLY SIGNIFICANT: Yes
RECEIVED DATE: 05/30/2026 LEGAL DEADLINE: None  


AGENCY: HHS-CMS RIN: 0938-AW01 Status: Pending Review for rule 0938-AW01 Request EO Meeting for rule 0938-AW01
TITLE: Request for Information; Clinical Laboratory Improvement Amendments (CLIA) of 1988 Regulations (CMS-3485)
STAGE: Notice ECONOMICALLY SIGNIFICANT: No
RECEIVED DATE: 06/01/2026 LEGAL DEADLINE: None  


AGENCY: HHS-CMS RIN: 0938-AV74 Status: Pending Review for rule 0938-AV74 Request EO Meeting for rule 0938-AV74
TITLE: Guarding U.S. Medicare Against Rising Drug Costs (GUARD) Model (CMS-5546)
STAGE: Final Rule ECONOMICALLY SIGNIFICANT: Yes
RECEIVED DATE: 06/15/2026 LEGAL DEADLINE: Statutory  


AGENCY: HHS-CMS RIN: 0938-AV73 Status: Pending Review for rule 0938-AV73 Request EO Meeting for rule 0938-AV73
TITLE: Prohibition on Federal Medicaid and Children's Health Insurance Program Funding for Specified Sex-Rejecting Procedures Furnished to Children and Youth (CMS-2451)
STAGE: Final Rule ECONOMICALLY SIGNIFICANT: Yes
RECEIVED DATE: 06/16/2026 LEGAL DEADLINE: None  


AGENCY: HHS-CMS RIN: 0938-AV75 Status: Pending Review for rule 0938-AV75 Request EO Meeting for rule 0938-AV75
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: Final Rule ECONOMICALLY SIGNIFICANT: Yes
RECEIVED DATE: 06/18/2026 LEGAL DEADLINE: Statutory  


AGENCY: HHS-CMS RIN: 0938-AV93 Status: Pending Review for rule 0938-AV93 Request EO Meeting for rule 0938-AV93
TITLE: Amending the Indirect Hold Harmless Threshold of Health Care-Related Taxes (CMS-2452)
STAGE: Proposed Rule ECONOMICALLY SIGNIFICANT: Yes
RECEIVED DATE: 12/31/2025 LEGAL DEADLINE: Statutory  


AGENCY: HHS-FDA RIN: 0910-AI94 Status: Pending Review for rule 0910-AI94 Request EO Meeting for rule 0910-AI94
TITLE: Drug Establishment Registration and Drug Listing Requirements for Establishments Engaged in Distributed Manufacturing and Certain Foreign Establishments
STAGE: Proposed Rule ECONOMICALLY SIGNIFICANT: No
RECEIVED DATE: 03/04/2026 LEGAL DEADLINE: Statutory  


AGENCY: HHS-FDA RIN: 0910-ZC82 Status: Pending Review for rule 0910-ZC82 Request EO Meeting for rule 0910-ZC82
TITLE: Cannabidiol (CBD) Products Compliance and Enforcement Policy
STAGE: Notice ECONOMICALLY SIGNIFICANT: No
RECEIVED DATE: 03/13/2026 LEGAL DEADLINE: None  


AGENCY: HHS-FDA RIN: 0910-ZC89 Status: Pending Review for rule 0910-ZC89 Request EO Meeting for rule 0910-ZC89
TITLE: Serotonin-2A Agonists and Related Products: Considerations for Clinical Investigations; Guidance for Industry; Availability
STAGE: Notice ECONOMICALLY SIGNIFICANT: No
RECEIVED DATE: 04/17/2026 LEGAL DEADLINE: None  


AGENCY: HHS-FDA RIN: 0910-AI72 Status: Pending Review for rule 0910-AI72 Request EO Meeting for rule 0910-AI72
TITLE: Use of Salt Substitutes to Reduce the Sodium Content in Standardized Foods
STAGE: Final Rule ECONOMICALLY SIGNIFICANT: No
RECEIVED DATE: 04/20/2026 LEGAL DEADLINE: None  


AGENCY: HHS-FDA RIN: 0910-AI98 Status: Pending Review for rule 0910-AI98 Request EO Meeting for rule 0910-AI98
TITLE: Food Standards of Identity Modernization; Pasteurized Orange Juice
STAGE: Final Rule ECONOMICALLY SIGNIFICANT: No
RECEIVED DATE: 05/08/2026 LEGAL DEADLINE: None  


AGENCY: HHS-FDA RIN: 0910-ZD09 Status: Pending Review for rule 0910-ZD09 Request EO Meeting for rule 0910-ZD09
TITLE: Action Levels for Cadmium in Processed Food Intended for Babies and Young Children; Draft Guidance for Industry
STAGE: Notice ECONOMICALLY SIGNIFICANT: No
RECEIVED DATE: 05/22/2026 LEGAL DEADLINE: None  


AGENCY: HHS-FDA RIN: 0910-ZD12 Status: Pending Review for rule 0910-ZD12 Request EO Meeting for rule 0910-ZD12
TITLE: Biosimilar and Interchangeable Biosimilar Products: Considerations for Container Closure Systems and Device Constituent Parts; Draft Guidance for Industry; Availability
STAGE: Notice ECONOMICALLY SIGNIFICANT: No
RECEIVED DATE: 05/27/2026 LEGAL DEADLINE: None  


AGENCY: HHS-FDA RIN: 0910-ZD15 Status: Pending Review for rule 0910-ZD15 Request EO Meeting for rule 0910-ZD15
TITLE: Requirements for Additional Traceability Records for Certain Foods: Enforcement Policy for Certain Retail Food Establishments and Restaurants
STAGE: Notice ECONOMICALLY SIGNIFICANT: No
RECEIVED DATE: 06/01/2026 LEGAL DEADLINE: None  


AGENCY: HHS-FDA RIN: 0910-ZD23 Status: Pending Review for rule 0910-ZD23 Request EO Meeting for rule 0910-ZD23
TITLE: New Dietary Ingredient (NDI) Notifications and Related Issues; Identity and Safety Information About the NDI: Guidance for Industry
STAGE: Notice ECONOMICALLY SIGNIFICANT: No
RECEIVED DATE: 06/02/2026 LEGAL DEADLINE: None  


AGENCY: HHS-FDA RIN: 0910-AJ03 Status: Pending Review for rule 0910-AJ03 Request EO Meeting for rule 0910-AJ03
TITLE: Requirements For Additional Traceability Records For Certain Foods: Compliance Date Extension
STAGE: Final Rule ECONOMICALLY SIGNIFICANT: No
RECEIVED DATE: 06/03/2026 LEGAL DEADLINE: None  


AGENCY: HHS-FDA RIN: 0910-AI91 Status: Pending Review for rule 0910-AI91 Request EO Meeting for rule 0910-AI91
TITLE: Rulemaking to Provide by Regulation that an Ingredient Is Not Excluded From the Dietary Supplement Definition
STAGE: Proposed Rule ECONOMICALLY SIGNIFICANT: No
RECEIVED DATE: 06/05/2026 LEGAL DEADLINE: None  


AGENCY: HHS-FDA RIN: 0910-ZC37 Status: Pending Review for rule 0910-ZC37 Request EO Meeting for rule 0910-ZC37
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: No
RECEIVED DATE: 07/10/2025 LEGAL DEADLINE: None  


AGENCY: HHS-FDA RIN: 0910-AJ02 Status: Pending Review for rule 0910-AJ02 Request EO Meeting for rule 0910-AJ02
TITLE: Substances Generally Recognized as Safe
STAGE: Proposed Rule ECONOMICALLY SIGNIFICANT: No
RECEIVED DATE: 12/01/2025 LEGAL DEADLINE: None  


AGENCY: HHS-HRSA RIN: 0906-ZA23 Status: Pending Review for rule 0906-ZA23 Request EO Meeting for rule 0906-ZA23
TITLE: Notice Regarding 340B Rebate Model Pilot Program
STAGE: Prerule ECONOMICALLY SIGNIFICANT: No
RECEIVED DATE: 05/27/2026 LEGAL DEADLINE: None  


AGENCY: HHS-NIH RIN: 0925-ZA11 Status: Pending Review for rule 0925-ZA11 Request EO Meeting for rule 0925-ZA11
TITLE: Request for Information: Inviting Input on NIDA's Strategic Plan for 2027-2031
STAGE: Notice ECONOMICALLY SIGNIFICANT: No
RECEIVED DATE: 06/15/2026 LEGAL DEADLINE: None  


AGENCY: HHS-NIH RIN: 0925-ZA12 Status: Pending Review for rule 0925-ZA12 Request EO Meeting for rule 0925-ZA12
TITLE: Inviting Comments and Suggestions on Topic Areas for the NIDCR Strategic Plan for Fiscal Years 2027–2031
STAGE: Notice ECONOMICALLY SIGNIFICANT: No
RECEIVED DATE: 06/15/2026 LEGAL DEADLINE: None  


AGENCY: HHS-NIH RIN: 0925-ZA13 Status: Pending Review for rule 0925-ZA13 Request EO Meeting for rule 0925-ZA13
TITLE: Request for Information: Draft NIH Biosafety Policy for Research Involving Biohazards
STAGE: Prerule ECONOMICALLY SIGNIFICANT: No
RECEIVED DATE: 06/17/2026 LEGAL DEADLINE: None  


AGENCY: HHS-OCR RIN: 0945-AA00 Status: Pending Review for rule 0945-AA00 Request EO Meeting for rule 0945-AA00
TITLE: HIPAA Privacy Rule: Changes to Support Coordinated Care and Individual Engagement and Reduce Regulatory Burdens
STAGE: Final Rule ECONOMICALLY SIGNIFICANT: Yes
RECEIVED DATE: 04/02/2026 LEGAL DEADLINE: None  


AGENCY: HHS-OCR RIN: 0945-AA29 Status: Pending Review for rule 0945-AA29 Request EO Meeting for rule 0945-AA29
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: No
RECEIVED DATE: 04/24/2026 LEGAL DEADLINE: None  


AGENCY: HHS-OCR RIN: 0945-AA31 Status: Pending Review for rule 0945-AA31 Request EO Meeting for rule 0945-AA31
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: No
RECEIVED DATE: 06/04/2026 LEGAL DEADLINE: None  


AGENCY: HHS-SAMHSA RIN: 0930-AA40 Status: Pending Review for rule 0930-AA40 Request EO Meeting for rule 0930-AA40
TITLE: Mandatory Guidelines for Federal Workplace Drug Testing Programs using Urine (UrMG)
STAGE: Notice ECONOMICALLY SIGNIFICANT: No
RECEIVED DATE: 06/11/2026 LEGAL DEADLINE: None  


AGENCY: HHS-SAMHSA RIN: 0930-AA41 Status: Pending Review for rule 0930-AA41 Request EO Meeting for rule 0930-AA41
TITLE: Mandatory Guidelines for Federal Workplace Drug Testing Programs using Oral Fluid (OFMG)
STAGE: Notice ECONOMICALLY SIGNIFICANT: No
RECEIVED DATE: 06/11/2026 LEGAL DEADLINE: None