Agency Rule List - Spring 2024

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 Prerule Stage Recalls of Products Subject to the Jurisdiction of the Food and Drug Administration 0910-AI86
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 Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food 0910-AH77
HHS/FDA Proposed Rule Stage Permanent Listing of Color Additive Lakes 0910-AH80
HHS/FDA Proposed Rule Stage Amendments to Registration of Food Facilities 0910-AH82
HHS/FDA Proposed Rule Stage Administrative Detention of Tobacco Products 0910-AI05
HHS/FDA Proposed Rule Stage Requirements for Determining Donor Eligibility and Donation Suitability of Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use 0910-AI11
HHS/FDA Proposed Rule Stage Biologics Regulation Modernization 0910-AI14
HHS/FDA Proposed Rule Stage Conditional Approval of New Animal Drugs for Minor Use and Minor Species 0910-AI18
HHS/FDA Proposed Rule Stage Clinical Holds in Medical Device Investigations 0910-AI20
HHS/FDA Proposed Rule Stage Streamlining Provisions Requiring Disclosure to and Receipt of Written Assurances From Commercial Customers in the Foreign Supplier Verification Programs Rule 0910-AI23
HHS/FDA Proposed Rule Stage Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals 0910-AI24
HHS/FDA Proposed Rule Stage The FDA Food Safety Modernization Act: Amendments to Exemption Provisions in the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption Regulation 0910-AI25
HHS/FDA Proposed Rule Stage Amendments to Patent Term Restoration 0910-AI29
HHS/FDA Proposed Rule Stage Amendment to Records and Reports Concerning Adverse Drug Experiences on Marketed Prescription Drugs for Human Use Without Approved New Drug Applications 0910-AI30
HHS/FDA Proposed Rule Stage Medical Devices; Cardiovascular Devices; Classification of More Than Minimally Manipulated Allograft Heart Valves 0910-AI33
HHS/FDA Proposed Rule Stage Phased Review of New Animal Drug Applications, Electronic Submission, and Master Files 0910-AI35
HHS/FDA Proposed Rule Stage Labeling Requirements for Approved or Conditionally Approved New Animal Drugs 0910-AI43
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 Contact Lens Devices; Designation of Special Controls for Daily Wear Contact Lenses 0910-AI58
HHS/FDA Proposed Rule Stage Submission of Food and Drug Administration Import Data in the Automated Commercial Environment for Certain Tobacco Products 0910-AI64
HHS/FDA Proposed Rule Stage Certifications Concerning Imported Foods 0910-AI66
HHS/FDA Proposed Rule Stage 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 Requirements for Requesting Records in Advance of or in Lieu of an Inspection, and Participation in a Remote Interactive Evaluation, of an Establishment that Manufactures Certain HCT/Ps 0910-AI78
HHS/FDA Proposed Rule Stage Food Standards; General Principles and Food Standards Modernization 0910-AI79
HHS/FDA Proposed Rule Stage Front-of-Package Nutrition Labeling 0910-AI80
HHS/FDA Proposed Rule Stage Testing Methods for Detecting and Identifying Asbestos in Talc-Containing Cosmetic Products 0910-AI82
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 Amendments to the Current Good Manufacturing Practice Regulations for Drug Products 0910-AI88
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 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 Proposed Rule Stage Radiology Devices; Classification of Blood Irradiator Devices 0910-AI93
HHS/FDA Proposed Rule Stage Drug Establishment Registration Requirements for Establishments Engaged in Distributed Manufacturing and Certain Foreign Establishments 0910-AI94
HHS/FDA Proposed Rule Stage Sterility Requirements for Ophthalmic Preparations 0910-AI95
HHS/FDA Proposed Rule Stage Modernizing the Standard of Identity for Maple Syrup 0910-AI96
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 General and Plastic Surgery Devices: Restricted Sale, Distribution, and Use of Sunlamp Products 0910-AH14
HHS/FDA Final Rule Stage Food Labeling: Health Claims; Soy Protein and Coronary Heart Disease 0910-AH43
HHS/FDA Final Rule Stage Nonprescription Drug Product With an Additional Condition for Nonprescription Use 0910-AH62
HHS/FDA Final Rule Stage Revision of Product Jurisdiction Regulations 0910-AH71
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 Requirements for Tobacco Product Manufacturing Practice 0910-AH91
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 Nutrient Content Claims, Definition of Term: Healthy 0910-AI13
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 Cheeses and Related Cheese Products; Proposal to Permit the Use of Ultrafiltered Milk 0910-AI42
HHS/FDA Final Rule Stage Prohibition of Sale of Tobacco Products to Persons Younger Than 21 Years of Age 0910-AI51
HHS/FDA Final Rule Stage Revising the National Drug Code Format and Drug Labeling Barcode Requirements 0910-AI52
HHS/FDA Final Rule Stage Revocation of Methods of Analysis Regulation 0910-AI65
HHS/FDA Final Rule Stage Color Additive Certification; Increase in Fees for Certification Services 0910-AI69
HHS/FDA Final Rule Stage Use of Salt Substitutes to Reduce the Sodium Content in Standardized Foods 0910-AI72
HHS/FDA Final Rule Stage Amendment to Establishment Registration and Device Listing Requirements for Manufacturers of Human Cells, Tissues, and Cellular and Tissue-Based Products Regulated as Devices 0910-AI73
HHS/FDA Final Rule Stage Fish and Shellfish; Canned Tuna Standard of Identity and Standard of Fill of Container 0910-AI74
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 The Revocation of Authorization of Use of Brominated Vegetable Oil in Food 0910-AI81
HHS/FDA Final Rule Stage Amendments to Regulatory Hearing Before the Food and Drug Administration 0910-AI97
HHS/IHS Proposed Rule Stage Medical Quality Assurance Records Regulations 0917-AA20
HHS/IHS Proposed Rule Stage Calendar Year 2025 Reimbursement Rates Notice 0917-AA25
HHS/IHS Final Rule Stage Catastrophic Health Emergency Fund (CHEF) 0917-AA10
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 Respirator Fit Capability Test Standard, Filter Shelf Life, and Application Requirements for Air-Purifying Particulate Respirators 0920-AA77
HHS/CDC Proposed Rule Stage Import Regulations for Infectious Biological Agents, Infectious Substances, and Vectors 0920-AA85
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 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/CDC Final Rule Stage Updated World Trade Center Health Program Eligibility Requirements for Shanksville, Pennsylvania, and Pentagon Responders 0920-AA86
HHS/NIH Proposed Rule Stage Privacy Act Exempt Record System for NIH Police Records; Implementation 0925-AA69
HHS/NIH Final Rule Stage National Institute on Minority Health and Health Disparities Research Endowment Program 0925-AA70
HHS/SAMHSA Proposed Rule Stage Mandatory Guidelines for Federal Workplace Drug Testing Programs--Hair 0930-AA33
HHS/OIG Proposed Rule Stage Health Care Programs: Fraud and Abuse; Revisions to the Office of Inspector General's Exclusion Authorities 0936-AA12
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/OASH Proposed Rule Stage Federal Policy for the Protection of Human Subjects: Updates to Reduce Administrative Burdens 0937-AA10
HHS/OASH Proposed Rule Stage Organ Procurement and Transplantation: Implementation of the HIV Organ Policy Equity Act 0937-AA13
HHS/OASH Final Rule Stage HHS Policy for the Protection of Human Research Subjects: Updates to the Additional Protections for Specific Populations (Subparts B, C, and D) 0937-AA09
HHS/OASH Final Rule Stage Public Health Service Policies on Research Misconduct 0937-AA12
HHS/CMS Proposed Rule Stage Reporting of Crimes Occurring in Federally Funded Long Term Care Facilities and Enforcement Under Section 1150B of the Social Security Act (CMS-3359) 0938-AT60
HHS/CMS Proposed Rule Stage Alternative Payment Model Updates; Increasing Organ Transplant Access (IOTA) Model (CMS-5535) 0938-AU51
HHS/CMS Proposed Rule Stage Amendments to Rules Governing Organ Procurement Organizations (CMS-3409) 0938-AU54
HHS/CMS Proposed Rule Stage Medicare Advantage and Medicare Prescription Drug Benefit Program Payment Policy (CMS-4198) 0938-AU59
HHS/CMS Proposed Rule Stage Provider Nondiscrimination Requirements for Group Health Plans and Health Insurance Issuers in the Group and Individual Markets (CMS-9910) 0938-AU64
HHS/CMS Proposed Rule Stage Healthcare System Resiliency and Modernization (CMS-3426) 0938-AU91
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 Mitigating the Impact of Anomalous Increases in Billing on Medicare Shared Savings Program Financial Calculations (CMS-1799) 0938-AV20
HHS/CMS Proposed Rule Stage Emergency Preparedness Requirements for Medicare and Medicaid Participating Providers and Suppliers II 0938-AV21
HHS/CMS Proposed Rule Stage CY 2025 Changes to the End-Stage Renal Disease (ESRD) Prospective Payment System and Quality Incentive Program (CMS-1805) 0938-AV27
HHS/CMS Proposed Rule Stage CY 2025 Home Health Prospective Payment System Rate Update and Home Infusion Therapy and Home IVIG Services Payment Update (CMS-1803) 0938-AV28
HHS/CMS Proposed Rule Stage CY 2025 Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Medicare Part B (CMS-1807) 0938-AV33
HHS/CMS Proposed Rule Stage CY 2025 Hospital Outpatient PPS Policy Changes and Payment Rates and Ambulatory Surgical Center Payment System Policy Changes and Payment Rates (CMS-1809) 0938-AV35
HHS/CMS Proposed 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 Proposed Rule Stage HHS Notice of Benefit and Payment Parameters for 2026 (CMS-9888) 0938-AV41
HHS/CMS Proposed Rule Stage Administrative Simplification: Modifications to the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Electronic Transaction Standards Version 8020 (CMS-0061) 0938-AV43
HHS/CMS Proposed Rule Stage Interoperability Standards and Prior Authorization for Drugs (CMS-0062) 0938-AV44
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 Misclassification of Drugs, Program Administration and Program Integrity Updates Under the Medicaid Drug Rebate Program (CMS-2434) 0938-AU28
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 Transitional Coverage for Emerging Technologies; Response to Comments (CMS-3421) 0938-AU86
HHS/CMS Final Rule Stage Mental Health Parity and Addiction Equity Act and the Consolidated Appropriations Act, 2021 (CMS-9902) 0938-AU93
HHS/CMS Final Rule Stage Coverage of Certain Preventive Services Under the Affordable Care Act (CMS-9903) 0938-AU94
HHS/CMS Final Rule Stage Independent Dispute Resolution Operations (CMS-9897) 0938-AV15
HHS/CMS Final Rule Stage FY 2025 Hospice Wage Index, Payment Rate Update, and Quality Reporting Requirements (CMS-1810) 0938-AV29
HHS/CMS Final Rule Stage FY 2025 Skilled Nursing Facility (SNFs) Prospective Payment System and Consolidated Billing and Updates to the Value-Based Purchasing and Quality Reporting Programs (CMS-1802) 0938-AV30
HHS/CMS Final Rule Stage FY 2025 Inpatient Rehabilitation Facility (IRF) Prospective Payment System Rate Update and Quality Reporting Program (CMS-1804) 0938-AV31
HHS/CMS Final Rule Stage FY 2025 Inpatient Psychiatric Facilities Prospective Payment System Rate and Quality Reporting Updates (CMS-1806) 0938-AV32
HHS/CMS Final Rule Stage Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals; the Long-Term Care Hospital Prospective Payment System; and FY 2025 Rates (CMS-1808) 0938-AV34
HHS/CMS Final Rule Stage CY 2025 Inpatient Hospital Deductible and Hospital and Extended Care Services Coinsurance Amounts (CMS-8086) 0938-AV36
HHS/CMS Final Rule Stage CY 2025 Part A Premiums for the Uninsured Aged and for Certain Disabled Individuals Who Have Exhausted Other Entitlement (CMS-8087) 0938-AV37
HHS/CMS Final Rule Stage Medicare Part B Monthly Actuarial Rates, Premium Rates, and Annual Deductible Beginning January 1, 2025 (CMS-8088) 0938-AV38
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/OCR Proposed Rule Stage Proposed Modifications to the HIPAA Security Rule to Strengthen the Cybersecurity of Electronic Protected Health Information 0945-AA22
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/ONC Proposed Rule Stage Request for Information Regarding Electronic Prior Authorization in the ONC Health IT Certification Program 0955-AA04
HHS/ONC Proposed Rule Stage Health Data, Technology, and Interoperability: Patient Engagement, Information Sharing, and Public Health Interoperability 0955-AA06
HHS/ONC Final Rule Stage Establishment of Disincentives for Health Care Providers Who Have Committed Information Blocking 0955-AA05
HHS/ACF Proposed Rule Stage Standards for Data Exchange 0970-AC58
HHS/ACF Proposed Rule Stage Updating Refugee Resettlement Program Requirements 0970-AC74
HHS/ACF Proposed Rule Stage Updating Native Employment Works Requirements 0970-AC83
HHS/ACF Proposed Rule Stage Federal Licensing of Office of Refugee Resettlement Facilities 0970-AC94
HHS/ACF Proposed Rule Stage Employment and Training Services for Noncustodial Parents in the Child Support Services Program 0970-AD00
HHS/ACF Proposed Rule Stage Native American Programs Financial and Administrative Requirements 0970-AD05
HHS/ACF Proposed Rule Stage Name Change From Office of Child Support Enforcement to Office of Child Support Services 0970-AD06
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 Increase Flexibility for Tribes in Child Care and Development Fund (CCDF) Eligibility 0970-AD11
HHS/ACF Final Rule Stage Strengthening Temporary Assistance for Needy Families (TANF) as a Safety Net Program 0970-AC97
HHS/ACF Final Rule Stage Adoption and Foster Care Analysis and Reporting System (AFCARS) 0970-AC98
HHS/ACF Final Rule Stage Supporting the Head Start Workforce and Other Quality Improvements 0970-AD01
HHS/ACF Final Rule Stage Temporary Assistance for Needy Families Work Outcomes Measures 0970-AD04
HHS/ACF Final Rule Stage Head Start Program CLASS Effective Date Delay Direct Final Rule 0970-AD09
HHS/ACF Final Rule Stage ORR UC Program Child Abuse and Neglect 0970-AD10
HHS/OS Proposed Rule Stage Privacy Act Regulations 0991-AC05
HHS/OS Proposed Rule Stage Health and Human Services Acquisition Regulation: Standards for Health Information Technology 0991-AC35
HHS/OS Proposed Rule Stage HHS Acquisition Regulation: Regulatory Review 0991-AC36
HHS/OS Proposed Rule Stage HHS Acquisition Regulation: Part 339, Acquisition of Information Technology; Other Parts; Supply Chain Risk Management 0991-AC37
HHS/OS Final Rule Stage Use of Federal Property to Assist the Homeless 0991-AC14
HHS/OS Final Rule Stage HHS Adoption of Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards 0991-AC26
HHS/OS Final Rule Stage CY 2023 Civil Monetary Penalties Inflation Adjustment 0991-AC34