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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