Agency Rule List - Spring 2025


Department of Health and Human Services

Agency Agenda Stage of Rulemaking Title RIN
HHS/HRSA Proposed Rule Stage Countermeasures Injury Compensation Program: COVID-19 Countermeasures Injury Table 0906-AB31
HHS/FDA Proposed Rule Stage Post Approval Changes to Approved Applications 0910-AH55
HHS/FDA Proposed Rule Stage Current Good Manufacturing Practice for Positron Emission Tomography Drugs 0910-AH58
HHS/FDA Proposed Rule Stage Establishment Registration and Product Listing for Tobacco Products 0910-AH59
HHS/FDA Proposed Rule Stage Current Good Manufacturing Practice for Outsourcing Facilities 0910-AH61
HHS/FDA Proposed Rule Stage Amending Regulations That Require Multiple Copies Submissions 0910-AI50
HHS/FDA Proposed Rule Stage Conduct of Analytical and Clinical Pharmacology, Bioavailability, and Bioequivalence Studies 0910-AI57
HHS/FDA Proposed Rule Stage Postmarketing Safety Reporting Requirements, Pharmacovigilance Plans, and Pharmacovigilance Quality Systems for Human Drug and Biological Products 0910-AI61
HHS/FDA Proposed Rule Stage Additional Amendments to the Final Rule Regarding the List of Bulk Substances That Can Be Used to Compound Drug Products in Accordance With Section 503A of the Federal Food, Drug, and Cosmetic Act 0910-AI70
HHS/FDA Proposed Rule Stage Distribution of Compounded Drug Products Under Section 503A of the Federal Food, Drug, and Cosmetic Act 0910-AI71
HHS/FDA Proposed Rule Stage Amendments to the Regulation Regarding the List of Drug Products That Have Been Withdrawn or Removed From the Market for Reasons of Safety or Effectiveness 0910-AI77
HHS/FDA Proposed Rule Stage Use of Formaldehyde and Formaldehyde-Releasing Chemicals as an Ingredient in Hair Smoothing Products or Hair Straightening Products 0910-AI83
HHS/FDA Proposed Rule Stage Registration of Commercial Importers of Drugs; Good Importing Practice 0910-AI87
HHS/FDA Proposed Rule Stage Pediatric Study Plan Requirements for New Drug and Biologics License Applications 0910-AI89
HHS/FDA Proposed Rule Stage Disclosure of Fragrance Allergens in Cosmetic Labeling 0910-AI90
HHS/FDA Proposed Rule Stage Rulemaking to Provide by Regulation that an Ingredient Is Not Excluded From the Dietary Supplement Definition 0910-AI91
HHS/FDA Proposed Rule Stage Radiology Devices; Classification of Blood Irradiator Devices 0910-AI93
HHS/FDA Proposed Rule Stage Drug Establishment Registration and Drug Listing Requirements for Establishments Engaged in Distributed Manufacturing and Certain Foreign Establishments 0910-AI94
HHS/FDA Proposed Rule Stage Food Standards of Identity Modernization; Pasteurized Orange Juice 0910-AI98
HHS/FDA Proposed Rule Stage Substances Generally Recognized as Safe 0910-AJ02
HHS/FDA Proposed Rule Stage Requirements For Additional Traceability Records For Certain Foods: Compliance Date Extension 0910-AJ03
HHS/FDA Proposed Rule Stage Revocation of Food Standards for 11 Products Not Currently Sold 0910-AJ06
HHS/FDA Proposed Rule Stage Proposal to Revoke 18 Standards of Identity for Dairy Products 0910-AJ11
HHS/FDA Proposed Rule Stage Proposal to Revoke 23 Standards of Identity for Foods 0910-AJ12
HHS/FDA Final Rule Stage Fixed-Combination and Co-Packaged Drugs: Applications for Approval and Combinations of Active Ingredients Under Consideration for Inclusion in an Over-the-Counter Drug Monograph 0910-AF89
HHS/FDA Final Rule Stage Sunlamp Products; Amendment to the Performance Standard 0910-AG30
HHS/FDA Final Rule Stage Investigational New Drug Applications; Exemptions for Clinical Investigations to Evaluate a Drug Use of a Product Lawfully Marketed as a Conventional Food, Dietary Supplement, or Cosmetic 0910-AH07
HHS/FDA Final Rule Stage Amendments to the List of Bulk Drug Substances That Can Be Used To Compound Drug Products in Accordance With Section 503A of the Federal Food, Drug, and Cosmetic Act 0910-AH81
HHS/FDA Final Rule Stage Protection of Human Subjects and Institutional Review Boards 0910-AI07
HHS/FDA Final Rule Stage Institutional Review Boards; Cooperative Research 0910-AI08
HHS/FDA Final Rule Stage Medical Devices; Immunology and Microbiology Devices; Classification of Human Leukocyte, Neutrophil and Platelet Antigen and Antibody Tests 0910-AI12
HHS/FDA Final Rule Stage Medical Devices; General and Plastic Surgery Devices; Classification of Certain Solid Wound Dressings, Wound Dressings Formulated as a Gel, Cream, or Ointment, and Liquid Wound Washes 0910-AI26
HHS/FDA Final Rule Stage Drug Products or Categories of Drug Products That Present Demonstrable Difficulties for Compounding Under Sections 503A or 503B of the Federal Food, Drug, and Cosmetic Act 0910-AI31
HHS/FDA Final Rule Stage Investigational New Drug Application Annual Reporting 0910-AI37
HHS/FDA Final Rule Stage Cheeses and Related Cheese Products; Proposal to Permit the Use of Ultrafiltered Milk 0910-AI42
HHS/FDA Final Rule Stage Labeling Requirements for Approved or Conditionally Approved New Animal Drugs 0910-AI43
HHS/FDA Final Rule Stage Revising the National Drug Code Format and Drug Label Barcode Requirements 0910-AI52
HHS/FDA Final Rule Stage Submission of Food and Drug Administration Import Data in the Automated Commercial Environment for Certain Tobacco Products 0910-AI64
HHS/FDA Final Rule Stage Revocation of Methods of Analysis Regulation 0910-AI65
HHS/FDA Final Rule Stage Revision of Requirements for the Establishment and Maintenance of Records Related to Medicated Animal Feed and Veterinary Feed Directive Drugs 0910-AI67
HHS/FDA Final Rule Stage Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs That Are Regulated Under a Biologics License Application, and Animal Drugs 0910-AI68
HHS/FDA Final Rule Stage Use of Salt Substitutes to Reduce the Sodium Content in Standardized Foods 0910-AI72
HHS/FDA Final Rule Stage Prior Notice: Adding Requirement to Submit Mail Tracking Number for Articles of Food Arriving by International Mail and Timeframe for Post-refusal and Post-hold Submissions 0910-AI75
HHS/FDA Final Rule Stage Front-of-Package Nutrition Labeling 0910-AI80
HHS/FDA Final Rule Stage Testing Methods for Detecting and Identifying Asbestos in Talc-Containing Cosmetic Products 0910-AI82
HHS/FDA Final Rule Stage Banned Devices; Electrical Stimulation Devices Intended for Self-Injurious Behavior or Aggressive Behavior 0910-AI84
HHS/FDA Final Rule Stage Revocation of the Mutual Recognition of Pharmaceutical Good Manufacturing Practice, Medical Device Quality System Audit, and Certain Medical Device Product Evaluation Reports: U.S. and the E.C. 0910-AI92
HHS/FDA Final Rule Stage Update of FDA Regulations Implementing the Procedural Provisions of the National Environmental Policy Act 0910-AJ04
HHS/FDA Final Rule Stage Medical Devices; Laboratory Developed Tests; Rescission 0910-AJ05
HHS/IHS Prerule Stage Calendar Year 2026 Reimbursement Rates Notice 0917-AA26
HHS/IHS Proposed Rule Stage Medical Quality Assurance Records Regulations 0917-AA20
HHS/IHS Final Rule Stage Removal of Suspended Regulations 0917-AA13
HHS/IHS Final Rule Stage Removal of Obsolete Portion of Regulation Relating to Care and Treatment of Ineligible Individuals 0917-AA14
HHS/CDC Proposed Rule Stage Import Regulations for Infectious Biological Agents, Infectious Substances, Vectors, and Nucleic Acids Capable of Producing Infectious Viruses 0920-AA85
HHS/CDC Proposed Rule Stage Control of Communicable Diseases; Foreign Quarantine: Dog Importation 0920-AA87
HHS/CDC Final Rule Stage Approval Tests and Standards for Air-Purifying Particulate Respirators 0920-AA69
HHS/CDC Final Rule Stage Possession, Use, and Transfer of Select Agents and Toxins; Biennial Review of the List of Select Agents and Toxins 0920-AA71
HHS/CDC Final Rule Stage Control of Communicable Diseases; Foreign Quarantine 0920-AA75
HHS/CDC Final Rule Stage Approval Tests and Standards for Combination Unit Respirators 0920-AA83
HHS/NIH Final Rule Stage Minority Biomedical Research Support Program -- Recission 0925-AA72
HHS/SAMHSA Proposed Rule Stage Mandatory Guidelines for Federal Workplace Drug Testing Programs--Hair 0930-AA33
HHS/OIG Proposed Rule Stage Medicare and State Health Care Programs: Fraud and Abuse; Establishment of New Safe Harbors Under the Federal Anti-Kickback Statute 0936-AA13
HHS/OIG Final Rule Stage Health Care Programs: Fraud and Abuse; Revisions to the Office of Inspector General's Exclusion Authorities 0936-AA12
HHS/OASH Proposed Rule Stage US Public Health Service Commissioned Corps Officers: Updates to Appointment Standards 0937-AA14
HHS/OASH Proposed Rule Stage Compliance with Title X Statutory Program Integrirty Requirements 0937-AA15
HHS/CMS Prerule Stage Ensuring Safety through Domestic Security with Made in America Personal Protective Equipment (PPE) and Essential Medicine Procurement by Medicare Providers and Suppliers (CMS-1516) 0938-AV72
HHS/CMS Proposed Rule Stage Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) Competitive Bidding Program (CBP) Revisions (CMS-1756) 0938-AU45
HHS/CMS Proposed Rule Stage Amendments to Rules Governing Organ Procurement Organizations (CMS-3409) 0938-AU54
HHS/CMS Proposed Rule Stage Requirements Related to Advanced Explanation of Benefits and Other Provisions Under the Consolidated Appropriations Act 2021 (CMS-9900) 0938-AU98
HHS/CMS Proposed Rule Stage Administrative Simplification: Modifications to the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Electronic Transaction Standards (CMS-0061) 0938-AV43
HHS/CMS Proposed Rule Stage Interoperability Standards and Prior Authorization for Drugs (CMS-0062) 0938-AV44
HHS/CMS Proposed Rule Stage CY 2026 Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Medicare Part B (CMS-1832) 0938-AV50
HHS/CMS Proposed Rule Stage CY 2026 Hospital Outpatient PPS Policy Changes and Payment Rates and Ambulatory Surgical Center Payment System Policy Changes and Payment Rates (CMS-1834) 0938-AV51
HHS/CMS Proposed Rule Stage CY 2026 Changes to the End-Stage Renal Disease (ESRD) Prospective Payment System and Quality Incentive Program (CMS-1830) 0938-AV52
HHS/CMS Proposed Rule Stage CY 2026 Home Health Prospective Payment System Rate and Durable Medical Equipment, Prosthetics, Orthotics, and Supplies Competitive Bidding Program Updates (CMS-1828) 0938-AV53
HHS/CMS Proposed Rule Stage Preserving Medicaid Funding for Vulnerable Populations – Closing a Health Care-Related Tax Loophole (CMS-2448) 0938-AV58
HHS/CMS Proposed Rule Stage End-Stage Renal Disease (ESRD) Treatment Choices (ETC) Model Updates (CMS-5543) 0938-AV60
HHS/CMS Proposed Rule Stage HHS Notice of Benefit and Payment Parameters for 2027 (CMS-9883) 0938-AV62
HHS/CMS Proposed Rule Stage 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) 0938-AV63
HHS/CMS Proposed Rule Stage Transparency in Coverage (CMS-9882) 0938-AV64
HHS/CMS Proposed Rule Stage Center for Medicare & Medicaid Innovation Payment Models (CMS-5544) 0938-AV65
HHS/CMS Proposed Rule Stage Center for Medicare & Medicaid Innovation Payment Models (CMS-5545) 0938-AV66
HHS/CMS Proposed Rule Stage Medicaid Managed Care State Directed Payments and Medicaid Fee-For-Service Targeted Medicaid Practitioner Payments (CMS-2449) 0938-AV69
HHS/CMS Proposed Rule Stage Strengthening the Integrity of Medicaid and CHIP Eligibility, Managed Care, Financing and Section 1115 Demonstrations (CMS-2450) 0938-AV70
HHS/CMS Final Rule Stage Administrative Simplification: Adoption of Standards for Health Care Attachment Transactions and Electronic Signatures (CMS-0053) 0938-AT38
HHS/CMS Final Rule Stage Administrative Simplification: Modifications to NCPDP Retail Pharmacy Standards (CMS-0056) 0938-AU19
HHS/CMS Final Rule Stage Requirements Related to Air Ambulance Services, Agent and Broker Disclosures, and Provider Enforcement (CMS-9907) 0938-AU61
HHS/CMS Final Rule Stage Independent Dispute Resolution Operations (CMS-9897) 0938-AV15
HHS/CMS Final Rule Stage Contract Year 2026 Policy and Technical Changes to the Medicare Advantage, Medicare Prescription Drug Benefit, and Medicare Cost Plan Programs, and PACE (CMS-4208) 0938-AV40
HHS/CMS Final Rule Stage Administrative Simplification: Modifications of Operating Rules for Eligibility for a Health Plan, Health Care Claim Status and Health Care EFT and ERA Transactions (CMS-0060) 0938-AV42
HHS/CMS Final Rule Stage Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals; the Long-Term Care Hospital Prospective Payment System; and FY 2026 Rates (CMS-1833) 0938-AV45
HHS/CMS Final Rule Stage FY 2026 Inpatient Psychiatric Facilities Prospective Payment System Rate and Quality Reporting Updates (CMS-1831) 0938-AV46
HHS/CMS Final Rule Stage FY 2026 Skilled Nursing Facility (SNFs) Prospective Payment System and Consolidated Billing and Updates to the Value-Based Purchasing and Quality Reporting Programs (CMS-1827) 0938-AV47
HHS/CMS Final Rule Stage FY 2026 Inpatient Rehabilitation Facility (IRF) Prospective Payment System Rate Update and Quality Reporting Program (CMS-1829) 0938-AV48
HHS/CMS Final Rule Stage FY 2026 Hospice Wage Index, Payment Rate Update, and Quality Reporting Requirements (CMS-1835) 0938-AV49
HHS/CMS Final Rule Stage CY 2026 Inpatient Hospital Deductible and Hospital and Extended Care Services Coinsurance Amounts (CMS-8089) 0938-AV54
HHS/CMS Final Rule Stage CY 2026 Part A Premiums for the Uninsured Aged and for Certain Disabled Individuals Who Have Exhausted Other Entitlement (CMS-8090) 0938-AV55
HHS/CMS Final Rule Stage Medicare Part B Monthly Actuarial Rates, Premium Rates, and Annual Deductible Beginning January 1, 2026 (CMS-8091) 0938-AV56
HHS/CMS Final Rule Stage Changes Under the Affordable Care Act of 2010; Giving States Additional Flexibility to Use Immigration Information to Determine State Residency for Medicaid and CHIP Eligibility (CMS-2349) 0938-AV71
HHS/OCR Proposed Rule Stage Rulemaking on Nondiscrimination on the Basis of Disability in Programs and Activities Conducted by the Department of Health and Human Services 0945-AA23
HHS/OCR Proposed Rule Stage Making Technical Changes And Clarifying How OCR Addresses Conscience Authorities In Health Care; Delegation of Authority 0945-AA24
HHS/OCR Proposed Rule Stage Clarifying Statutory Limitation on Disability as it Applies to Gender Identity and Dysphoria in Nondiscrimination in Programs and Activities Receiving Federal Financial Assistance. 0945-AA27
HHS/OCR Final Rule Stage HIPAA Privacy Rule: Changes to support, remove barriers to coordinated care, and individual engagement 0945-AA00
HHS/OCR Final Rule Stage HIPAA Security Rule to Strengthen the Cybersecurity of Electronic Protected Health Information 0945-AA22
HHS/ASTP/ONC Proposed Rule Stage Health Data, Technology, and Interoperability: ASTP/ONC Deregulatory Actions to Unleash Prosperity 0955-AA09
HHS/ASTP/ONC Final Rule Stage Request for Information Regarding Electronic Prior Authorization in the ONC Health IT Certification Program 0955-AA04
HHS/ASTP/ONC Final Rule Stage Health Data, Technology, and Interoperability: Patient Engagement, Information Sharing, and Public Health Interoperability 0955-AA08
HHS/ACF Proposed Rule Stage Standards for Data Exchange 0970-AC58
HHS/ACF Proposed Rule Stage Updating Native Employment Works Requirements 0970-AC83
HHS/ACF Proposed Rule Stage Office of Refugee Resettlement Federal Licensure NPRM 0970-AC94
HHS/ACF Proposed Rule Stage Native American Programs Financial and Administrative Requirements 0970-AD05
HHS/ACF Proposed Rule Stage Temporary Assistance for Needy Families Work Participation Rate Calculation Changes 0970-AD07
HHS/ACF Proposed Rule Stage Unaccompanied Children Program Prevention of Sexual Abuse NPRM 0970-AD08
HHS/ACF Proposed Rule Stage Revisions to the Runaway and Homeless Youth Program Regulation 0970-AD14
HHS/ACF Proposed Rule Stage COVID-19 Mitigation Policy Requirement in Head Start Programs; Recission 0970-AD17
HHS/ACF Proposed Rule Stage Employment and Training Services for Noncustodial Parents in the Child Support Program final rule; Rescission 0970-AD18
HHS/ACF Proposed Rule Stage Restoring Flexibility to the Child Care and Development Fund (CCDF) 0970-AD20
HHS/ACF Proposed Rule Stage Restoring Flexibility to Support Head Start Program Access and Quality 0970-AD21
HHS/ACF Proposed Rule Stage Implementing requirements of the Supporting America's Children and Families Act, Public Law 118-258 and Tribal Child Support Enforcement (IV-D) Program technical corrections 0970-AD23
HHS/ACF Final Rule Stage Office of Refugee Resettlement Child Abuse and Neglect Investigations Rule 0970-AD10
HHS/ACF Final Rule Stage Unaccompanied Children Program Foundational Rule; Update to Accord with Statutory Requirements 0970-AD16
HHS/ACF Final Rule Stage Designated Placements Requirements Under Titles IV-E and IV-B for LQBTQ+ Children; Recission 0970-AD19
HHS/ACF Final Rule Stage Office of Refugee Resettlement UC Bureau Foundational Rule Update IFR 0970-AD22
HHS/ACF Final Rule Stage Office of Refugee Resettlement Refugee Program Refugee Support Services Funding Clarification 0970-AD25
HHS/ACL Proposed Rule Stage Older Americans Act, Title III, VI, and VII 0985-AA19
HHS/OS Proposed Rule Stage Privacy Act Regulations 0991-AC05
HHS/OS Proposed Rule Stage HHS Acquisition Regulation: Part 339, Acquisition of Information Technology; Other Parts; Supply Chain Risk Management 0991-AC37
HHS/OS Proposed Rule Stage HHS Acquisition Regulation: Supply Chain Risk Assessments 0991-AC39
HHS/OS Proposed Rule Stage Reforming Accreditation to Strengthen Graduate Medical Education 0991-AC41
HHS/OS Final Rule Stage Health and Human Services Acquisition Regulation: Standards for Health Information Technology 0991-AC35
HHS/OS Final Rule Stage HHS Acquisition Regulation: Regulatory Review 0991-AC36
HHS/OS Final Rule Stage CY 2024 Civil Monetary Penalties Inflation Adjustment 0991-AC38
HHS/OS Final Rule Stage Standards of Conduct 0991-AC40