Agency Rule List - Spring 2021


Department of Health and Human Services

Agency Agenda Stage of Rulemaking Title RIN
HHS/HRSA Final Rule Stage Countermeasures Injury Compensation Program; Smallpox Countermeasures Injury Table 0906-AB22
HHS/HRSA Final Rule Stage National Vaccine Injury Compensation Program: Adding the Category of Vaccines Recommended for Pregnant Women to the Vaccine Injury Table 0906-AB27
HHS/FDA Proposed Rule Stage Food Standards: General Principles and Food Standards Modernization 0910-AC54
HHS/FDA Proposed 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 Proposed Rule Stage National Standards for the Licensure of Wholesale Drug Distributors and Third-Party Logistics Providers 0910-AH11
HHS/FDA Proposed Rule Stage Post Approval Changes to Approved Applications 0910-AH55
HHS/FDA Proposed Rule Stage Certain Requirements Regarding Prescription Drug Marketing (203 Amendment) 0910-AH56
HHS/FDA Proposed Rule Stage Current Good Manufacturing Practice for Positron Emission Tomography Drugs 0910-AH58
HHS/FDA Proposed Rule Stage Nonprescription Drug Product With an Additional Condition for Nonprescription Use 0910-AH62
HHS/FDA Proposed Rule Stage Medication Guide; Patient Medication Information 0910-AH68
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 Amendments to Registration of Food Facilities 0910-AH82
HHS/FDA Proposed Rule Stage Requirements for Tobacco Product Manufacturing Practice 0910-AH91
HHS/FDA Proposed Rule Stage Updated Regulations for Medical Gases 0910-AH96
HHS/FDA Proposed Rule Stage Harmonizing and Modernizing Regulation of Medical Device Quality Systems 0910-AH99
HHS/FDA Proposed Rule Stage Food Additives: Food Contact Substance Notification That Is No Longer Effective 0910-AI01
HHS/FDA Proposed Rule Stage Administrative Detention of Tobacco Products 0910-AI05
HHS/FDA Proposed Rule Stage Part 50 Protection of Human Subjects and Part 56 Institutional Review Boards 0910-AI07
HHS/FDA Proposed Rule Stage Institutional Review Boards; Cooperative Research 0910-AI08
HHS/FDA Proposed Rule Stage Medical Devices; Immunology and Microbiology Devices; Classification of Human Leukocyte, Neutrophil and Platelet Antigen or Antibody Tests 0910-AI12
HHS/FDA Proposed Rule Stage Nutrient Content Claims, Definition of Term: Healthy 0910-AI13
HHS/FDA Proposed Rule Stage Revocation of Uses of Partially Hydrogenated Oils in Foods 0910-AI15
HHS/FDA Proposed Rule Stage Medical Devices; Ear, Nose and Throat Devices; Establishing Over-the-Counter Hearing Aids and Aligning Other Regulations 0910-AI21
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 Classification of Wound Dressings Containing Antimicrobials and/or Other Chemicals 0910-AI26
HHS/FDA Proposed Rule Stage Tobacco Product Standard for Characterizing Flavors in Cigars 0910-AI28
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 Drug Products That Present Demonstrable Difficulties for Compounding Under Sections 503A and 503B of the Federal Food Drug and Cosmetic Act 0910-AI31
HHS/FDA Proposed Rule Stage Classification of Spinal Spheres For Use in Intervertebral Fusion Procedures 0910-AI32
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 Investigational New Drug Application Annual Reporting 0910-AI37
HHS/FDA Proposed Rule Stage Modified Risk Tobacco Product Applications 0910-AI38
HHS/FDA Proposed Rule Stage Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption 0910-AI49
HHS/FDA Proposed Rule Stage Amending Regulations That Require Multiple Copies Submissions 0910-AI50
HHS/FDA Proposed Rule Stage Revising the National Drug Code Format and Drug Labeling Barcode Requirements 0910-AI52
HHS/FDA Proposed Rule Stage Amendment of Procedural Requirements for Color Additive Petitions 0910-AI53
HHS/FDA Proposed Rule Stage Abbreviated New Animal Drug Applications 0910-AI54
HHS/FDA Proposed Rule Stage Amendment of Procedural Requirements for Food Additive Petitions 0910-AI55
HHS/FDA Proposed Rule Stage Conduct of Analytical and Clinical Pharmacology, Bioavailability and Bioequivalence Studies 0910-AI57
HHS/FDA Proposed Rule Stage Administrative Destruction of Certain Devices Refused Admission to the United States 0910-AI59
HHS/FDA Proposed Rule Stage Tobacco Product Standard for Menthol in Cigarettes 0910-AI60
HHS/FDA Final Rule Stage Import Tolerances for Residues of Unapproved New Animal Drugs in Food 0910-AF78
HHS/FDA Final Rule Stage Mammography Quality Standards Act 0910-AH04
HHS/FDA Final Rule Stage Laboratory Accreditation for Analyses of Foods 0910-AH31
HHS/FDA Final Rule Stage Premarket Tobacco Product Applications and Recordkeeping Requirements 0910-AH44
HHS/FDA Final Rule Stage Biologics License Applications and Master Files 0910-AH50
HHS/FDA Final Rule Stage Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations 0910-AH52
HHS/FDA Final Rule Stage Medical Device De Novo Classification Process 0910-AH53
HHS/FDA Final Rule Stage Radiological Health Regulations; Amendments to Records and Reports for Radiation Emitting Electronic Products; Amendments to Performance Standards for Diagnostic X-ray, Laser, and Ultrasonic Products 0910-AH65
HHS/FDA Final Rule Stage Submission of Food and Drug Administration Import Data in the Automated Commercial Environment for Veterinary Devices 0910-AH66
HHS/FDA Final Rule Stage Updating Public Information Regulations 0910-AH69
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 Format and Content of Reports Intended to Demonstrate Substantial Equivalence 0910-AH89
HHS/FDA Final Rule Stage Amendment to Add a New Method for the Analysis of Sulfites in Foods 0910-AI02
HHS/FDA Final Rule Stage Beverages: Bottled Water 0910-AI03
HHS/FDA Final Rule Stage Revised Procedures for the Announcement of Approvals and Denials of Premarket Approval Applications and Humanitarian Device Exemption Applications 0910-AI10
HHS/FDA Final Rule Stage French Dressing; Proposed Revocation of a Standard of Identity 0910-AI16
HHS/FDA Final Rule Stage Frozen Cherry Pie; Proposed Revocation of a Standard of Identity and a Standard of Quality 0910-AI17
HHS/FDA Final Rule Stage Annual Summary Reporting Requirements Under the Right to Try Act 0910-AI36
HHS/FDA Final Rule Stage Revocation for the Regulation for Human Tissue Intended For Transplantation and Human Dura Mater 0910-AI41
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 Defining "Small Number of Animals" for Minor Use Designation; Periodic Reassessment 0910-AI46
HHS/FDA Final Rule Stage Regulations Regarding "Intended Uses" 0910-AI47
HHS/FDA Final Rule Stage Prohibition of Sale of Tobacco Products to Persons Younger Than 21 Years of Age 0910-AI51
HHS/IHS Prerule Stage Calendar Year 2022 Reimbursement Rates 0917-AA21
HHS/IHS Proposed Rule Stage Catastrophic Health Emergency Fund (CHEF) 0917-AA10
HHS/IHS Proposed Rule Stage Acquisition Regulations; Buy Indian Act; Procedures for Contracting 0917-AA18
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 Respirator Certification Fees; Fee Schedule Update 0920-AA70
HHS/CDC Proposed Rule Stage Possession, Use, and Transfer of Select Agents and Toxins; Biennial Review 0920-AA71
HHS/CDC Proposed Rule Stage Development of Regulatory Requirements for Respirator Fit Capability Test Standards for Air-Purifying, Half-Facepiece, Particulate Respirators 0920-AA77
HHS/CDC Proposed Rule Stage NIOSH Respirator Approval Program: Penalties for Fraud and Fraudulent Statements 0920-AA78
HHS/CDC Final Rule Stage Approval Tests and Standards for Air-Purifying Particulate Respirators 0920-AA69
HHS/CDC Final Rule Stage Control of Communicable Diseases; Foreign Quarantine 0920-AA75
HHS/NIH Proposed Rule Stage Conduct of Persons and Traffic on the National Institutes of Health Federal Enclave 0925-AA67
HHS/NIH Proposed Rule Stage National Institutes of Health Loan Repayment Programs 0925-AA68
HHS/NIH Final Rule Stage Privacy Act; Exempt Record System for NIH Division of Loan Repayment Records; Implementation 0925-AA62
HHS/SAMHSA Proposed Rule Stage Mandatory Guidelines for Federal Workplace Drug Testing Programs--Urine 0930-AA36
HHS/SAMHSA Proposed Rule Stage Mandatory Guidelines for Federal Workplace Drug Testing Programs--Oral/Fluid 0930-AA37
HHS/SAMHSA Final Rule Stage Mandatory Guidelines for Federal Workplace Drug Testing Programs--Hair 0930-AA33
HHS/OIG Final Rule Stage Amendments to Civil Monetary Penalty Law Regarding Grants, Contracts, and Information Blocking 0936-AA09
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 Ensuring Access to Equitable, Affordable, Client-centered, Quality Family Planning Services 0937-AA11
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/CMS Prerule Stage Request for Information: Transplant System Modernization (CMS-3409) 0938-AU55
HHS/CMS Prerule Stage Requirements Related to Prescription Drug Reporting (CMS-9905) 0938-AU66
HHS/CMS Proposed Rule Stage Administrative Simplification: Adoption of Standards for Health Care Attachment Transactions and Electronic Signatures, and Modification to Referral Certification and Authorization Standard (CMS-0053) 0938-AT38
HHS/CMS Proposed Rule Stage Clinical Laboratory Improvement Amendments (CLIA) Fees (CMS-3356) 0938-AT56
HHS/CMS Proposed Rule Stage Establishing Minimum Standards in Medicaid State Drug Utilization Review (DUR) and Supporting Value Based Payments (VBP) for Drugs Covered in Medicaid (CMS-2482) 0938-AT82
HHS/CMS Proposed Rule Stage Medicare Secondary Payer and Future Medicals (CMS-6047) 0938-AT85
HHS/CMS Proposed Rule Stage Streamlining the Medicaid and Chip Application, Eligibility Determination, Enrollment, and Renewal Processes (CMS-2421) 0938-AU00
HHS/CMS Proposed Rule Stage Administrative Simplification: Modifications to NCPDP Retail Pharmacy Standards (CMS-0056) 0938-AU19
HHS/CMS Proposed Rule Stage Electronic Prescribing for Controlled Substances (CMS-3394) 0938-AU25
HHS/CMS Proposed Rule Stage Medicaid Drug Misclassification, Beneficiary Access Protection, and Drug Program Administration (CMS 2434) 0938-AU28
HHS/CMS Proposed Rule Stage Contract Year 2023 Policy and Technical Changes to the Medicare Advantage and Medicare Prescription Drug Benefit Programs (CMS-4192) 0938-AU30
HHS/CMS Proposed Rule Stage FY 2022 Skilled Nursing Facility (SNFs) Prospective Payment System Rate Update and Quality Reporting Requirements (CMS-1746) 0938-AU36
HHS/CMS Proposed Rule Stage CY 2022 Home Health Prospective Payment System Rate Update, Home Infusion Therapy Services, and Quality Reporting Requirements (CMS-1747) 0938-AU37
HHS/CMS Proposed Rule Stage FY 2022 Inpatient Rehabilitation Facility (IRF) Prospective Payment System Rate Update and Quality Reporting Requirements (CMS-1748) 0938-AU38
HHS/CMS Proposed Rule Stage CY 2022 Changes to the End-Stage Renal Disease (ESRD) Prospective Payment System and Quality Incentive Program (CMS-1749) 0938-AU39
HHS/CMS Proposed Rule Stage FY 2022 Inpatient Psychiatric Facilities Prospective Payment System Rate and Quality Reporting Updates (CMS-1750) 0938-AU40
HHS/CMS Proposed Rule Stage FY 2022 Hospice Wage Index, Payment Rate Update, and Quality Reporting Requirements (CMS-1754) 0938-AU41
HHS/CMS Proposed Rule Stage CY 2022 Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Medicare Part B (CMS-1751) 0938-AU42
HHS/CMS Proposed Rule Stage CY 2022 Hospital Outpatient PPS Policy Changes and Payment Rates and Ambulatory Surgical Center Payment System Policy Changes and Payment Rates (CMS-1753) 0938-AU43
HHS/CMS Proposed Rule Stage Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals; the Long-Term Care Hospital Prospective Payment System; and FY 2022 Rates (CMS-1752) 0938-AU44
HHS/CMS Proposed Rule Stage Alternative Payment Model (CMS-5532) 0938-AU51
HHS/CMS Proposed Rule Stage Mandatory Medicaid and Children's Health Insurance Plan (CHIP) Core Set Reporting (CMS-2440) 0938-AU52
HHS/CMS Proposed Rule Stage Amendments to Rules Governing Organ Procurement Organizations and Transplant Centers (CMS-3409) 0938-AU54
HHS/CMS Proposed Rule Stage Improving Infection Prevention and Control in Long Term Care Facilities (CMS-3405) 0938-AU58
HHS/CMS Proposed Rule Stage Medicare Advantage and Medicare Prescription Drug Benefit Program Payment Policy (CMS-4198) 0938-AU59
HHS/CMS Proposed Rule Stage Patient Protection and Affordable Care Act; Updating Payment Parameters and Improving Health Insurance Markets for 2022 and Beyond Proposed Rule (CMS-9906) 0938-AU60
HHS/CMS Proposed Rule Stage Reporting Requirements Related To Air Ambulance and Agent and Broker Services and HHS Enforcement Provisions (CMS-9907) 0938-AU61
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 HHS Notice of Benefit and Payment Parameters for 2023 (CMS-9911) 0938-AU65
HHS/CMS Proposed Rule Stage Assuring Access to Medicaid Services (CMS-2442) 0938-AU68
HHS/CMS Proposed Rule Stage Medicaid Managed Care Risk-Sharing Mechanisms (CMS-2443) 0938-AU69
HHS/CMS Final Rule Stage Proficiency Testing Regulations Related to Analytes and Acceptable Performance (CMS-3355) 0938-AT55
HHS/CMS Final Rule Stage Policy and Technical Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit Programs for Contract Year 2020; Risk Adjustment Data Validation (CMS-4185) 0938-AT59
HHS/CMS Final Rule Stage Medicare Coverage of Innovative Technology (MCIT) and Definition of "Reasonable and Necessary" (CMS-3372) 0938-AT88
HHS/CMS Final Rule Stage CY 2022 Inpatient Hospital Deductible and Hospital and Extended Care Services Coinsurance Amounts (CMS-8077) 0938-AU46
HHS/CMS Final Rule Stage CY 2022 Part A Premiums for the Uninsured Aged and for Certain Disabled Individuals Who Have Exhausted Other Entitlement (CMS-8078) 0938-AU47
HHS/CMS Final Rule Stage Medicare Part B Monthly Actuarial Rates, Premium Rates, and Annual Deductible Beginning January 1, 2022 (CMS-8079) 0938-AU48
HHS/CMS Final Rule Stage Modification of Limitations on Redesignation by the Medicare Geographic Classification Review Board (CMS-1762) 0938-AU56
HHS/CMS Final Rule Stage COVID-19 Vaccine Immunization Requirements for LTC Residents and Staff (CMS-3414) 0938-AU57
HHS/CMS Final Rule Stage Requirements Related to Surprise Billing; Part II (CMS-9908) 0938-AU62
HHS/CMS Final Rule Stage Requirements Related to Surprise Billing; Part I (CMS-9909) 0938-AU63
HHS/CMS Final Rule Stage Temporary Federal Medical Assistance Percentage (FMAP) increase under the Families First Coronavirus Response Act (FFCRA) (CMS-2492) 0938-AU70
HHS/OCR Prerule Stage HIPAA Rules: Request for Information on Sharing Civil Money Penalties or Monetary Settlements With Harmed Individuals, and Recognized Security Practices Under HITECH 0945-AA04
HHS/OCR Proposed Rule Stage HIPAA Privacy: Changes to Support, and Remove Barriers to, Coordinated Care and Individual Engagement 0945-AA00
HHS/OCR Proposed Rule Stage Rulemaking on Discrimination on the Basis of Disability in Critical Health and Human Services Programs or Activities 0945-AA15
HHS/OCR Proposed Rule Stage Confidentiality of Substance Use Disorder Patient Records 0945-AA16
HHS/OCR Proposed Rule Stage Nondiscrimination in Health Programs and Activities 0945-AA17
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 Native Hawaiian Revolving Loan Fund Eligibility Requirements 0970-AC84
HHS/ACF Proposed Rule Stage Paternity Establishment Percentage Performance Relief 0970-AC86
HHS/ACF Proposed Rule Stage Unaccompanied Children Program 0970-AC87
HHS/ACF Proposed Rule Stage ANA Non-federal Share Emergency Waivers 0970-AC88
HHS/ACF Final Rule Stage Standards To Prevent, Detect, and Respond to Sexual Abuse and Sexual Harassment Involving Unaccompanied Children 0970-AC61
HHS/ACF Final Rule Stage Flexibility for Head Start Designation Renewals in Certain Emergencies 0970-AC85
HHS/OS Proposed Rule Stage Privacy Act Regulations 0991-AC05
HHS/OS Proposed Rule Stage Limiting the Effect of Exclusions Implemented Under the Social Security Act 0991-AC11
HHS/OS Proposed Rule Stage Use of Federal Property to Assist the Homeless 0991-AC14
HHS/OS Proposed Rule Stage Securing Updated and Necessary Statutory Evaluations Timely 0991-AC24
HHS/OS Proposed Rule Stage HHS Requirements for Grants and Agreements 0991-AC26
HHS/OS Proposed Rule Stage Streamlining HHS Guidance Practices 0991-AC29
HHS/OS Proposed Rule Stage Partnerships with Faith-Based and Neighborhood Organizations 0991-AC31
HHS/OS Final Rule Stage Health Resources Priority and Allocations System (HRPAS) 0991-AB95
HHS/OS Final Rule Stage Health and Human Services Grants Regulation 0991-AC16
HHS/OS Final Rule Stage CY 2021 Civil Monetary Penalties Inflation Adjustment 0991-AC21