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-AD47 Status: Pending Review for rule 0970-AD47 Request EO Meeting for rule 0970-AD47
TITLE: Ensuring Program Integrity for Head Start Programs
STAGE: Proposed Rule ECONOMICALLY SIGNIFICANT: Yes
RECEIVED DATE: 08/05/2026 LEGAL DEADLINE: None  


AGENCY: HHS-ACF RIN: 0970-AD43 Status: Pending Review for rule 0970-AD43 Request EO Meeting for rule 0970-AD43
TITLE: Unaccompanied Alien Children Bureau Reunification of Certain Unaccompanied Alien Children with a Parent or Legal Guardian in a Country Other Than the United States
STAGE: Proposed Rule ECONOMICALLY SIGNIFICANT: No
RECEIVED DATE: 08/07/2026 LEGAL DEADLINE: None  


AGENCY: HHS-ACF RIN: 0970-AD49 Status: Pending Review for rule 0970-AD49 Request EO Meeting for rule 0970-AD49
TITLE: Reducing Bureaucracy and Burden for Block Grants
STAGE: Proposed Rule ECONOMICALLY SIGNIFICANT: No
RECEIVED DATE: 09/03/2026 LEGAL DEADLINE: None  


AGENCY: HHS-ACF RIN: 0970-AD21 Status: Pending Review for rule 0970-AD21 Request EO Meeting for rule 0970-AD21
TITLE: Restoring Flexibility to Support Head Start Program Access
STAGE: Final Rule ECONOMICALLY SIGNIFICANT: Yes
RECEIVED DATE: 09/10/2026 LEGAL DEADLINE: None  


AGENCY: HHS-ACF RIN: 0970-AD45 Status: Pending Review for rule 0970-AD45 Request EO Meeting for rule 0970-AD45
TITLE: Reducing Bureaucracy and Burden in Part 1370
STAGE: Proposed Rule ECONOMICALLY SIGNIFICANT: No
RECEIVED DATE: 09/15/2026 LEGAL DEADLINE: None  


AGENCY: HHS-ACF RIN: 0970-AD29 Status: Pending Review for rule 0970-AD29 Request EO Meeting for rule 0970-AD29
TITLE: Reducing Bureaucracy and Burden in the Child Care and Development Fund (CCDF)
STAGE: Proposed Rule ECONOMICALLY SIGNIFICANT: Yes
RECEIVED DATE: 09/17/2026 LEGAL DEADLINE: None  


AGENCY: HHS-ACF RIN: 0970-AD39 Status: Pending Review for rule 0970-AD39 Request EO Meeting for rule 0970-AD39
TITLE: Reducing Bureaucracy and Burden for Child Support Enforcement
STAGE: Final Rule ECONOMICALLY SIGNIFICANT: No
RECEIVED DATE: 09/28/2026 LEGAL DEADLINE: None  


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-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-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-AW04 Status: Pending Review for rule 0938-AW04 Request EO Meeting for rule 0938-AW04
TITLE: Cutting Administrative Requirements for Excellence in Patient Care (CMS-3484)
STAGE: Proposed Rule ECONOMICALLY SIGNIFICANT: Yes
RECEIVED DATE: 07/02/2026 LEGAL DEADLINE: None  


AGENCY: HHS-CMS RIN: 0938-AV99 Status: Pending Review for rule 0938-AV99 Request EO Meeting for rule 0938-AV99
TITLE: Patient Protection and Affordable Care Act; State Innovation Waivers and Health Care Choice Compacts (CMS-9877)
STAGE: Proposed Rule ECONOMICALLY SIGNIFICANT: Yes
RECEIVED DATE: 07/13/2026 LEGAL DEADLINE: None  


AGENCY: HHS-CMS RIN: 0938-AV97 Status: Pending Review for rule 0938-AV97 Request EO Meeting for rule 0938-AV97
TITLE: Comprehensive Regulations to Uncover Suspicious Healthcare (CRUSH) (CMS-6098)
STAGE: Proposed Rule ECONOMICALLY SIGNIFICANT: No
RECEIVED DATE: 08/07/2026 LEGAL DEADLINE: None  


AGENCY: HHS-CMS RIN: 0938-AU54 Status: Pending Review for rule 0938-AU54 Request EO Meeting for rule 0938-AU54
TITLE: Amendments to Rules Governing Organ Procurement Organizations (CMS-3409)
STAGE: Final Rule ECONOMICALLY SIGNIFICANT: No
RECEIVED DATE: 08/20/2026 LEGAL DEADLINE: Statutory  


AGENCY: HHS-CMS RIN: 0938-AV90 Status: Pending Review for rule 0938-AV90 Request EO Meeting for rule 0938-AV90
TITLE: Medicare Drug Price Negotiation Program (CMS-4215)
STAGE: Final Rule ECONOMICALLY SIGNIFICANT: Yes
RECEIVED DATE: 09/09/2026 LEGAL DEADLINE: None  


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: Final Rule ECONOMICALLY SIGNIFICANT: Yes
RECEIVED DATE: 09/17/2026 LEGAL DEADLINE: Statutory  


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: Final Rule ECONOMICALLY SIGNIFICANT: Yes
RECEIVED DATE: 09/17/2026 LEGAL DEADLINE: Statutory  


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: Final Rule ECONOMICALLY SIGNIFICANT: Yes
RECEIVED DATE: 09/21/2026 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: Final Rule ECONOMICALLY SIGNIFICANT: Yes
RECEIVED DATE: 09/29/2026 LEGAL DEADLINE: Statutory  


AGENCY: HHS-CMS RIN: 0938-AW00 Status: Pending Review for rule 0938-AW00 Request EO Meeting for rule 0938-AW00
TITLE: Expanding Access to Individual Coverage Health Reimbursement Arrangements (CMS-9876)
STAGE: Proposed Rule ECONOMICALLY SIGNIFICANT: No
RECEIVED DATE: 10/05/2026 LEGAL DEADLINE: None  


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-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-AI05 Status: Pending Review for rule 0910-AI05 Request EO Meeting for rule 0910-AI05
TITLE: Administrative Detention of Tobacco Products
STAGE: Proposed Rule ECONOMICALLY SIGNIFICANT: No
RECEIVED DATE: 07/09/2026 LEGAL DEADLINE: None  


AGENCY: HHS-FDA RIN: 0910-ZD48 Status: Pending Review for rule 0910-ZD48 Request EO Meeting for rule 0910-ZD48
TITLE: U.S.-Origin Statements on Seafood; Draft Guidance for Industry
STAGE: Notice ECONOMICALLY SIGNIFICANT: No
RECEIVED DATE: 07/10/2026 LEGAL DEADLINE: None  


AGENCY: HHS-FDA RIN: 0910-ZD60 Status: Pending Review for rule 0910-ZD60 Request EO Meeting for rule 0910-ZD60
TITLE: White Paper: Proposed Definition of Ultra-Processed Food
STAGE: Notice ECONOMICALLY SIGNIFICANT: No
RECEIVED DATE: 08/03/2026 LEGAL DEADLINE: None  


AGENCY: HHS-FDA RIN: 0910-AI83 Status: Pending Review for rule 0910-AI83 Request EO Meeting for rule 0910-AI83
TITLE: Use of Formaldehyde and Formaldehyde-Releasing Chemicals as an Ingredient in Hair Smoothing Products or Hair Straightening Products
STAGE: Proposed Rule ECONOMICALLY SIGNIFICANT: No
RECEIVED DATE: 08/06/2026 LEGAL DEADLINE: None  


AGENCY: HHS-FDA RIN: 0910-AI42 Status: Pending Review for rule 0910-AI42 Request EO Meeting for rule 0910-AI42
TITLE: Cheeses and Related Cheese Products; Proposal to Permit the Use of Ultrafiltered Milk and Microfiltered Milk
STAGE: Final Rule ECONOMICALLY SIGNIFICANT: No
RECEIVED DATE: 08/28/2026 LEGAL DEADLINE: None  


AGENCY: HHS-FDA RIN: 0910-AG30 Status: Pending Review for rule 0910-AG30 Request EO Meeting for rule 0910-AG30
TITLE: Sunlamp Products; Amendment to the Performance Standard
STAGE: Final Rule ECONOMICALLY SIGNIFICANT: No
RECEIVED DATE: 09/09/2026 LEGAL DEADLINE: None  


AGENCY: HHS-FDA RIN: 0910-ZD68 Status: Pending Review for rule 0910-ZD68 Request EO Meeting for rule 0910-ZD68
TITLE: Validation of Certain In Vitro Diagnostic Devices for Emerging Pathogens During a Section 564 Declared Emergency; Guidance for Industry and Food and Drug Administration Staff; Availability
STAGE: Notice ECONOMICALLY SIGNIFICANT: No
RECEIVED DATE: 09/10/2026 LEGAL DEADLINE: None  


AGENCY: HHS-FDA RIN: 0910-ZD81 Status: Pending Review for rule 0910-ZD81 Request EO Meeting for rule 0910-ZD81
TITLE: Potency Assurance for Cellular and Gene Therapy Products; Guidance for Industry; Availability
STAGE: Notice ECONOMICALLY SIGNIFICANT: No
RECEIVED DATE: 09/17/2026 LEGAL DEADLINE: None  


AGENCY: HHS-FDA RIN: 0910-ZD84 Status: Pending Review for rule 0910-ZD84 Request EO Meeting for rule 0910-ZD84
TITLE: Clinical Trial Enrollment Action Plans to Improve Representation of the U.S. Intended Use Population in Clinical Studies
STAGE: Notice ECONOMICALLY SIGNIFICANT: No
RECEIVED DATE: 10/06/2026 LEGAL DEADLINE: None  


AGENCY: HHS-FDA RIN: 0910-AJ34 Status: Pending Review for rule 0910-AJ34 Request EO Meeting for rule 0910-AJ34
TITLE: Infant Formula Nutrient Requirements
STAGE: Proposed Rule ECONOMICALLY SIGNIFICANT: Yes
RECEIVED DATE: 10/14/2026 LEGAL DEADLINE: None  


AGENCY: HHS-FDA RIN: 0910-ZD94 Status: Pending Review for rule 0910-ZD94 Request EO Meeting for rule 0910-ZD94
TITLE: Interim Access Policy for Compounding Using Certain Peptides
STAGE: Notice ECONOMICALLY SIGNIFICANT: No
RECEIVED DATE: 10/14/2026 LEGAL DEADLINE: None  


AGENCY: HHS-FDA RIN: 0910-ZD95 Status: Pending Review for rule 0910-ZD95 Request EO Meeting for rule 0910-ZD95
TITLE: Patient-level data for drugs and biological products submissions containing real-world data and real-world evidence; Request for Information
STAGE: Notice ECONOMICALLY SIGNIFICANT: No
** RECEIVED DATE: 10/15/2026 LEGAL DEADLINE: None  


AGENCY: HHS-NIH RIN: 0925-ZA21 Status: Pending Review for rule 0925-ZA21 Request EO Meeting for rule 0925-ZA21
TITLE: 2026 NIH Research Plan on Rehabilitation
STAGE: Notice ECONOMICALLY SIGNIFICANT: No
RECEIVED DATE: 09/11/2026 LEGAL DEADLINE: None  


AGENCY: HHS-NIH RIN: 0925-ZA22 Status: Pending Review for rule 0925-ZA22 Request EO Meeting for rule 0925-ZA22
TITLE: Request for Information: Developing Menopause Common Data Elements
STAGE: Notice ECONOMICALLY SIGNIFICANT: No
RECEIVED DATE: 09/28/2026 LEGAL DEADLINE: None  


AGENCY: HHS-NIH RIN: 0925-ZA25 Status: Pending Review for rule 0925-ZA25 Request EO Meeting for rule 0925-ZA25
TITLE: Draft Policy Update to the NIH Policy for Data and Safety Monitoring Request for Information
STAGE: Notice ECONOMICALLY SIGNIFICANT: No
RECEIVED DATE: 09/29/2026 LEGAL DEADLINE: None  


AGENCY: HHS-NIH RIN: 0925-ZA26 Status: Pending Review for rule 0925-ZA26 Request EO Meeting for rule 0925-ZA26
TITLE: Request for Information: Seeking New and Emerging Areas of Science Relevant to the NIDCD Mission, To Inform an Update of the NIDCD Strategic Plan for 2028-2032
STAGE: Notice ECONOMICALLY SIGNIFICANT: No
RECEIVED DATE: 10/01/2026 LEGAL DEADLINE: None  


AGENCY: HHS-NIH RIN: 0925-ZA27 Status: Pending Review for rule 0925-ZA27 Request EO Meeting for rule 0925-ZA27
TITLE: National Institute on Aging Strategic Directions 2026-2030
STAGE: Notice ECONOMICALLY SIGNIFICANT: No
RECEIVED DATE: 10/02/2026 LEGAL DEADLINE: None  


AGENCY: HHS-NIH RIN: 0925-ZA28 Status: Pending Review for rule 0925-ZA28 Request EO Meeting for rule 0925-ZA28
TITLE: Minority Health and Health Disparities Research Strategic Plan Fiscal Years 2026-2030
STAGE: Notice ECONOMICALLY SIGNIFICANT: No
RECEIVED DATE: 10/06/2026 LEGAL DEADLINE: None  


AGENCY: HHS-NIH RIN: 0925-ZA29 Status: Pending Review for rule 0925-ZA29 Request EO Meeting for rule 0925-ZA29
TITLE: Notice of Change: Updates to SBIR and STTR Foreign Risk Notification and Mitigation Process
STAGE: Notice ECONOMICALLY SIGNIFICANT: No
** RECEIVED DATE: 10/15/2026 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-AA27 Status: Pending Review for rule 0945-AA27 Request EO Meeting for rule 0945-AA27
TITLE: Nondiscrimination on the Basis of Disability in Programs or Activities Receiving Federal Financial Assistance
STAGE: Final Rule ECONOMICALLY SIGNIFICANT: No
RECEIVED DATE: 09/30/2026 LEGAL DEADLINE: None  


AGENCY: HHS-ONC RIN: 0955-AA09 Status: Pending Review for rule 0955-AA09 Request EO Meeting for rule 0955-AA09
TITLE: Health Data, Technology, and Interoperability: ASTP/ONC Deregulatory Actions to Unleash Prosperity
STAGE: Final Rule ECONOMICALLY SIGNIFICANT: Yes
RECEIVED DATE: 07/28/2026 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