Agency Rule List - Spring 2018

Department of Health and Human Services

Agency Agenda Stage of Rulemaking Title RIN
HHS/HRSA Proposed Rule Stage National Vaccine Injury Compensation Program: Revisions to the Vaccine Injury Table 0906-AB14
HHS/HRSA Proposed Rule Stage 340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties Regulation; Further Delay of Effective Date 0906-AB18
HHS/HRSA Final Rule Stage The Ricky Ray Hemophilia Relief Fund Program 0906-AB13
HHS/HRSA Final Rule Stage Private Practice Start-Up Loans for Former National Health Service Corps Members 0906-AB15
HHS/HRSA Final Rule Stage Rural Physician Training Grant Program, Definition of "Underserved Rural Community" 0906-AB17
HHS/FDA Prerule Stage Regulation of Flavors in Tobacco Products; Request for Information 0910-AH60
HHS/FDA Prerule Stage Tobacco Product Standard for Nicotine Level of Certain Tobacco Products; Request for Information 0910-AH86
HHS/FDA Prerule Stage Premium Cigars; Request for Scientific Information 0910-AH88
HHS/FDA Proposed Rule Stage Food Standards: General Principles and Food Standards Modernization (Reopening of Comment Period) 0910-AC54
HHS/FDA Proposed Rule Stage Over-the-Counter (OTC) Drug Review--Cough/Cold (Antihistamine) Products 0910-AF31
HHS/FDA Proposed Rule Stage Sunscreen Drug Products For Over-The-Counter-Human Use; Tentative Final Monograph 0910-AF43
HHS/FDA Proposed Rule Stage Pediatric Study Plan Requirements for New Drug and Biologics License Applications 0910-AG93
HHS/FDA Proposed Rule Stage Mammography Quality Standards Act; Amendments to Part 900 Regulations 0910-AH04
HHS/FDA Proposed Rule Stage Investigational New Drug Applications Requirements for Conventional Foods, Dietary Supplements, and Cosmetics 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 Laboratory Accreditation for Analyses of Foods 0910-AH31
HHS/FDA Proposed Rule Stage Premarket Tobacco Product Applications; Recordkeeping Requirements to Support the Legal Marketing of Certain Tobacco Products 0910-AH44
HHS/FDA Proposed Rule Stage Biologics License Applications and Master Files 0910-AH50
HHS/FDA Proposed Rule Stage Medical Device De Novo Classification Process 0910-AH53
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 Definition of the Term "Biological Product" 0910-AH57
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 Nonprescription Drug Product with an Additional Condition for Nonprescription Use 0910-AH62
HHS/FDA Proposed Rule Stage Medication Guides; Patient Medication Information 0910-AH68
HHS/FDA Proposed Rule Stage Updating Public Information Regulations 0910-AH69
HHS/FDA Proposed Rule Stage Revision of Product Jurisdiction Regulations 0910-AH71
HHS/FDA Proposed Rule Stage The Food and Drug Administration Food Safety Modernization Act; Removing Written Assurance Requirements From the Customer Provisions in Certain Implementing Rules 0910-AH77
HHS/FDA Proposed Rule Stage Permanent Listing of Color Additive Lakes 0910-AH80
HHS/FDA Proposed Rule Stage Amendments to the Final Rule Regarding 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 Proposed Rule Stage Amendments to Registration of Food Facilities 0910-AH82
HHS/FDA Proposed Rule Stage Food Labeling: Calorie Labeling of Articles of Food Sold From Certain Vending Machines; Front of Package Type Size 0910-AH83
HHS/FDA Proposed Rule Stage Format and Content of Reports Intended to Demonstrate Substantial Equivalence 0910-AH89
HHS/FDA Proposed Rule Stage Testing Standards for Batteries and Battery Management Systems in Electronic Nicotine Delivery Systems 0910-AH90
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 Proposed Rule to Revise the Allowable Level of Fluoride Added to Bottled Water 0910-AI03
HHS/FDA Proposed Rule Stage Administration Detention of Tobacco Products 0910-AI05
HHS/FDA Proposed Rule Stage Safety Standards for Toxicants and Impurities in Nicotine, Propylene Glycol, and Vegetable Glycerin Used in E-Liquids; Tobacco Product Standard 0910-AI06
HHS/FDA Proposed Rule Stage Institutional Review Boards; Cooperative Research 0910-AI08
HHS/FDA Proposed Rule Stage Responsibilities for the Initiation and Conduct of Clinical Investigations 0910-AI09
HHS/FDA Final Rule Stage Postmarketing Safety Reporting Requirements for Human Drug and Biological Products 0910-AA97
HHS/FDA Final Rule Stage Reporting Information Regarding Falsification of Data 0910-AC59
HHS/FDA Final Rule Stage Label Requirement for Food That Has Been Refused Admission Into the United States 0910-AF61
HHS/FDA Final Rule Stage Import Tolerances for Residues of Unapproved New Animal Drugs in Food 0910-AF78
HHS/FDA Final Rule Stage Laser Products; Amendment to Performance Standard 0910-AF87
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 Monograph 0910-AF89
HHS/FDA Final Rule Stage New Animal Drugs: Updating Tolerances for Residues of New Animal Drugs in Food 0910-AG17
HHS/FDA Final Rule Stage Electronic Submission of Labeling for Certain Home-Use Devices 0910-AG79
HHS/FDA Final Rule Stage Food Labeling; Gluten-Free Labeling of Fermented, Hydrolyzed, or Distilled Foods 0910-AH00
HHS/FDA Final Rule Stage 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-AH29
HHS/FDA Final Rule Stage Repeal of Regulation Requiring an Approved New Drug Application for Drugs Sterilized by Irradiation 0910-AH47
HHS/FDA Final Rule Stage Amending Premarket Regulations That Require Multiple Copies and Specify Paper Copies to be Allowed in Electronic Format 0910-AH48
HHS/FDA Final Rule Stage Postmarketing Safety Reports for Approved New Animal Drugs; Electronic Submission Requirements 0910-AH51
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 Devices; Hematology and Pathology Devices; Classification of Blood Establishment Computer Software 0910-AH54
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 Amendments and Repeal to Medical Device Software Regulations 0910-AH67
HHS/FDA Final Rule Stage Medical Devices; Medical Device Classification Procedures 0910-AH75
HHS/FDA Final Rule Stage Food Labeling: Revision of the Nutrition and Supplement Facts Labels and Serving Sizes of Foods 0910-AH92
HHS/FDA Final Rule Stage Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption, Extension of Compliance Dates for Subpart E 0910-AH93
HHS/FDA Final Rule Stage Revocation of the Test for Mycoplasma 0910-AH95
HHS/FDA Final Rule Stage Topical Antimicrobial Drug Products for Over-the-Counter Human Use: Final Monograph for Consumer Antiseptic Rub Products 0910-AH97
HHS/FDA Final Rule Stage Microbiology Devices; Classification of In Vitro Diagnostic Devices for Bacillus Species Detection 0910-AH98
HHS/FDA Final Rule Stage Classification of Posterior Cervical Screw Systems 0910-AI00
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 Crabmeat; Amendment of Common or Usual Name 0910-AI04
HHS/FDA Final Rule Stage Part 50 Protection of Human Subjects and Part 56 Institutional Review Boards 0910-AI07
HHS/IHS Proposed Rule Stage Removal of Suspended Regulations 0917-AA13
HHS/IHS Proposed Rule Stage Removal of Obsolete Portion of Regulation Relating to Care and Treatment of Ineligible Individuals 0917-AA14
HHS/CDC Proposed Rule Stage Clarification of Post-Approval Testing Standards for Closed-Circuit Escape Respirators 0920-AA66
HHS/NIH Proposed Rule Stage National Cancer Institute Clinical Cancer Education Program 0925-AA65
HHS/NIH Final Rule Stage Privacy Act; Exempt Record System for NIH Division of Loan Repayment Records 0925-AA62
HHS/NIH Final Rule Stage Privacy Act; Exempt Record System for NIH Electronic Research Administration (eRA) Records; Implementation 0925-AA63
HHS/SAMHSA Proposed Rule Stage Certification of Opioid Treatment Programs 0930-AA27
HHS/SAMHSA Proposed Rule Stage Mental Health and Substance Abuse Emergency Response Procedures 0930-AA28
HHS/SAMHSA Final Rule Stage Substance Abuse and Mental Health Services Administration Mandatory Guidelines for Federal Workplace Drug Testing Programs 0930-AA24
HHS/OIG Final Rule Stage Medicaid, Revisions to State Medicaid Fraud Control Unit Rules 0936-AA07
HHS/OASH Proposed Rule Stage Proposed 6-Month Delay of the General Compliance Date While Allowing the Use of Three Burden-Reducing Provisions During the Delay Period 0937-AA05
HHS/OASH Final Rule Stage Compliance With Title X Requirements By Project Recipients in Selecting Subrecipients 0937-AA04
HHS/CMS Proposed Rule Stage Prior Authorization Process as a Condition of Medicare Payment for Services Provided by Certain Chiropractors (CMS-6070-P) 0938-AS68
HHS/CMS Proposed Rule Stage Third Party Payments for Coverage Under Qualified Health Plans (CMS-3337-P) 0938-AT11
HHS/CMS Proposed Rule Stage Regulatory Provisions to Promote Program Efficiency, Transparency, and Burden Reduction (CMS-3346-P) 0938-AT23
HHS/CMS Proposed Rule Stage FY 2019 Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities (SNFs) (CMS-1696-P) 0938-AT24
HHS/CMS Proposed Rule Stage Inpatient Rehabilitation Facility Prospective Payment System for Federal Fiscal Year 2019 (CMS-1688-P) 0938-AT25
HHS/CMS Proposed Rule Stage FY 2019 Hospice Wage Index and Payment Rate Update and Hospice Quality Reporting Requirements (CMS-1692-P) 0938-AT26
HHS/CMS Proposed Rule Stage Hospital Inpatient Prospective Payment System for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and FY 2019 Rates (CMS-1694-P) 0938-AT27
HHS/CMS Proposed Rule Stage CY 2019 Changes to the End-Stage Renal Disease (ESRD) Prospective Payment System, Quality Incentive Program, Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) (CMS-1691-P) 0938-AT28
HHS/CMS Proposed Rule Stage CY 2019 Home Health Prospective Payment System Rate Update (CMS-1689-P) 0938-AT29
HHS/CMS Proposed Rule Stage CY 2019 Hospital Outpatient PPS Policy Changes and Payment Rates and Ambulatory Surgical Center Payment System Policy Changes and Payment Rates (CMS-1695-P) 0938-AT30
HHS/CMS Proposed Rule Stage CY 2019 Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Medicare Part B (CMS-1693-P) 0938-AT31
HHS/CMS Proposed Rule Stage FY 2019 Inpatient Psychiatric Facilities Prospective Payment System--Rate and Quality Reporting Updates (CMS-1690-P) 0938-AT32
HHS/CMS Proposed Rule Stage Requirements for Long-Term Care Facilities: Regulatory Provisions to Promote Program Efficiency, Transparency, and Burden Reduction (CMS-3347-P) 0938-AT36
HHS/CMS Proposed Rule Stage CY 2020 Notice of Benefit and Payment Parameters (CMS-9926-P) 0938-AT37
HHS/CMS Proposed Rule Stage Adoption of Standards for Health Care Attachments Transactions, Acknowledgments Transactions, Electronic Signatures, and Modification to Referral Certification and Authorization Standard (CMS-0053-P) 0938-AT38
HHS/CMS Proposed Rule Stage Medicaid and CHIP Managed Care and Medicaid Provider Enrollment and Terminations (CMS-2408-P) 0938-AT40
HHS/CMS Proposed Rule Stage Methods for Assuring Access to Care; Exceptions for High Managed Care Penetration and Rate Reduction Threshold (CMS-2406-PF) 0938-AT41
HHS/CMS Proposed Rule Stage Administrative Simplification: Rescinding the Adoption of the Standard Unique Health Plan Identifier and Other Entity Identifier (CMS-0054-P) 0938-AT42
HHS/CMS Proposed Rule Stage Medicare Shared Savings Program; Accountable Care Organizations (CMS-1701-P) 0938-AT45
HHS/CMS Proposed Rule Stage Grandfathered Health Plans in the Individual and Small Group Markets (CMS–9923–P ) 0938-AT49
HHS/CMS Proposed Rule Stage Medicaid Supplemental Payment and Accountability (CMS–2393–P) 0938-AT50
HHS/CMS Proposed Rule Stage Exchange Program Integrity (CMS-9922-P) 0938-AT53
HHS/CMS Proposed Rule Stage Proficiency Testing Regulations Related to Analytes and Acceptable Performance (CMS-3355-P) 0938-AT55
HHS/CMS Proposed Rule Stage Clinical Laboratory Improvement Amendments (CLIA) Fees (CMS-3356-P) 0938-AT56
HHS/CMS Proposed Rule Stage Medicaid Premiums and Cost Sharing (CMS-2411-P) 0938-AT57
HHS/CMS Proposed Rule Stage Policy and Technical Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit Programs for Contract Year 2020 (CMS-4185-P) 0938-AT59
HHS/CMS Proposed Rule Stage Civil Money Penalties and Exclusion Authority to Enforce 1150B Requirements (CMS-3359-P) 0938-AT60
HHS/CMS Proposed Rule Stage Medicaid Provider Payment Reassignment (CMS-2413-P) 0938-AT61
HHS/CMS Proposed Rule Stage Changes To the Medicare Claims, Medicare Advantage Organization Determination, and Medicare Prescription Drug Coverage Determination Appeals Procedures (CMS-4174-P) 0938-AT62
HHS/CMS Final Rule Stage Eligibility Notices, Fair Hearing and Appeal Processes for Medicaid, and Other Provisions Related to Eligibility and Enrollment for Medicaid and CHIP (CMS-2334-F3) 0938-AS55
HHS/CMS Final Rule Stage Revisions to Requirements for Discharge Planning for Hospitals, Critical Access Hospitals, and Home Health Agencies (CMS-3317-F) 0938-AS59
HHS/CMS Final Rule Stage Medicaid Disproportionate Share Hospital (DSH) Allotment Reductions (CMS-2394-F) 0938-AS63
HHS/CMS Final Rule Stage Program Integrity Enhancements to the Provider Enrollment Process (CMS-6058-F) 0938-AS84
HHS/CMS Final Rule Stage Covered Outpatient Drug; Finalization of Line Extension Definition and Delay in Including U.S. Territories in the Definitions of States and United States (CMS-2345-F2) 0938-AT09
HHS/CMS Final Rule Stage Durable Medical Equipment Fee Schedule, Adjustments to Resume the Transitional 50/50 Blended Rates to Provide Relief in Non-Competitive Bidding Areas (CMS-1687-IFC) 0938-AT21
HHS/CMS Final Rule Stage Inpatient Hospital Deductible and Hospital and Extended Care Services Coinsurance Amounts for CY 2019 (CMS-8068-N) 0938-AT33
HHS/CMS Final Rule Stage Part A Premiums for CY 2019 for the Uninsured Aged and for Certain Disabled Individuals Who Have Exhausted Other Entitlement (CMS-8069-N) 0938-AT34
HHS/CMS Final Rule Stage CY 2019 Part B Monthly Actuarial Rates, Monthly Premium Rates, and Annual Deductible (CMS-8070-N) 0938-AT35
HHS/CMS Final Rule Stage Moral Exemptions and Accommodations for Coverage of Certain Preventive Services Under the Affordable Care Act (CMS-9925-F) 0938-AT46
HHS/CMS Final Rule Stage Short-Term Limited Duration Insurance (CMS-9924-F) 0938-AT48
HHS/CMS Final Rule Stage Administrative Simplification: Update of Retail Pharmacy Standards (CMS-0055-IFC) 0938-AT52
HHS/CMS Final Rule Stage Religious Exemptions and Accommodations for Coverage of Certain Preventive Services Under the Affordable Care Act (CMS-9940-F2) 0938-AT54
HHS/OCR Prerule Stage HIPAA Enforcement: Distribution of a Percentage of Civil Money Penalties or Monetary Settlements to Harmed Individuals 0945-AA04
HHS/OCR Proposed Rule Stage HIPAA Privacy Rule: Accounting of Disclosures Under the Health Information Technology for Economic and Clinical Health Act 0945-AA00
HHS/OCR Proposed Rule Stage HIPAA Privacy Rule: Changing Requirement to Obtain Acknowledgment of Receipt of the Notice of Privacy Practices 0945-AA08
HHS/OCR Proposed Rule Stage HIPAA Privacy Rule: Presumption of Good Faith of HealthCare Providers 0945-AA09
HHS/OCR Proposed Rule Stage Nondiscrimination in Health Programs or Activities 0945-AA11
HHS/OCR Final Rule Stage Protecting Statutory Conscience Rights in Health Care; Delegations of Authority 0945-AA10
HHS/ONC Proposed Rule Stage Health Information Technology: Certification and Interoperability Enhancements 0955-AA01
HHS/ACF Prerule Stage Adoption and Foster Care Analysis and Reporting System 0970-AC72
HHS/ACF Proposed Rule Stage Implementation of The Settlement Reached in Jenny Lisette Flores, Et Al., V. Janet Reno, Attorney General of the United States, Et Al., Case No. CV 85-4544-RJK (C.D. Cal. 1966) 0970-AC42
HHS/ACF Proposed Rule Stage Standards for Data Exchange 0970-AC58
HHS/ACF Proposed Rule Stage Head Start Service Duration Requirements 0970-AC73
HHS/ACF Proposed Rule Stage Updating Refugee Resettlement Program Requirements 0970-AC74
HHS/ACF Proposed Rule Stage Child Support Enforcement Program Technical Corrections 0970-AC75
HHS/ACF Proposed Rule Stage Head Start Designation Renewal System 0970-AC77
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 Adoption and Foster Care Analysis and Reporting System 0970-AC76
HHS/ACL Proposed Rule Stage Older Americans Act Grants for Supportive and Nutritional Services to Older Hawaiian Natives 0985-AA14
HHS/ACL Proposed Rule Stage Older Americans Act Grants to Indian Tribes for Support and Nutrition Services 0985-AA15
HHS/OS Prerule Stage Privacy Act Regulations 0991-AC05
HHS/OS Proposed Rule Stage Privacy Act--Exemptions for Insider Threat Records 0991-AC10
HHS/OS Proposed Rule Stage Limiting the Effect of Exclusions implemented Under the Social Security Act 0991-AC11
HHS/OS Final Rule Stage Health Resources Priority and Allocations System (HRPAS) 0991-AB95