Agency Rule List - Fall 2017

Department of Health and Human Services

Agency Agenda Stage of Rulemaking Title RIN
HHS/HRSA Proposed Rule Stage 340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties Regulation 0906-AB12
HHS/HRSA Proposed Rule Stage National Vaccine Injury Compensation Program: Revisions to the Vaccine Injury Table 0906-AB14
HHS/HRSA Final Rule Stage 340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties Regulation – Further Delay of Effective Date 0906-AB11
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 Loan Repayment Terms for Private Practice Special Loans to Former National Health Service Corps Scholarship Recipients 0906-AB16
HHS/HRSA Final Rule Stage Rural Physician Training Grant Program, Definition of "Underserved Rural Community" 0906-AB17
HHS/FDA Prerule Stage Kid-Appealing Flavors in Tobacco Products; Request for Informaiton 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 Sunscreen Drug Products For Over-The-Counter-Human Use; Tentative Final Monograph 0910-AF43
HHS/FDA Proposed Rule Stage Laser Products; Amendment to Performance Standard 0910-AF87
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; Regulatory Amendments 0910-AH04
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 Internal Agency Review of Decisions; Requests for Supervisory Review of Certain Decisions Made by the Center for Devices and Radiological Health 0910-AH37
HHS/FDA Proposed Rule Stage Food Labeling: Health Claims; Soy Protein and Coronary Heart Disease 0910-AH43
HHS/FDA Proposed Rule Stage Biologics License Applications and Master Files 0910-AH50
HHS/FDA Proposed Rule Stage Postmarketing Safety Reports for Approved New Animal Drugs; Electronic Submission Requirements 0910-AH51
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 Amendment of Certain Requirements Under 21 CFR 203 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 Outsourcing Facilities 0910-AH61
HHS/FDA Proposed Rule Stage Requirement for Access or Safe Use of Certain Nonprescription Drug Products 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 Record Keeping Requirements Related to Tobacco Product Applications 0910-AH74
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 Suspension of Registration of Food Facilities 0910-AH79
HHS/FDA Proposed Rule Stage Permanent Listing of Color Additive Lakes 0910-AH80
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 Food Labeling: Revision of the Nutrition and Supplement Facts Labels and Serving Sizes of Foods That Can Reasonably Be Consumed At One Eating Occasion; Dual-Column Labeling; Updating, Modifying, and E 0910-AH92
HHS/FDA Proposed 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 Postmarketing Safety Reporting Requirements for Human Drug and Biological Products 0910-AA97
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 New Animal Drugs: Updating Tolerances for Residues of New Animal Drugs in Food 0910-AG17
HHS/FDA Final Rule Stage Human Subject Protection; Acceptance of Data From Clinical Investigations for Medical Devices 0910-AG48
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 Safety and Effectiveness of Healthcare Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use 0910-AH40
HHS/FDA Final Rule Stage Revocation 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 Removal of Time of Inspection and Duties of Inspector Regulations for Biological Products 0910-AH49
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 and Accessories 0910-AH54
HHS/FDA Final Rule Stage New Animal Drugs for Investigational Use; Disqualification of a Clinical Investigator 0910-AH64
HHS/FDA Final Rule Stage Radiological Health; Amendments to Records and Report Regulations 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 Medical Devices; Amendments to Medical Software Regulations 0910-AH67
HHS/FDA Final Rule Stage Medical Devices; Medical Device Classification Procedures 0910-AH75
HHS/IHS Prerule Stage Reimbursement Rates for Calendar Year 2018 0917-AA15
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 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/SAMHSA Final Rule Stage Confidentiality of Substance Use Disorder Patient Records 0930-AA26
HHS/OIG Final Rule Stage Medicaid, Revisions to State Medicaid Fraud Control Unit Rules 0936-AA07
HHS/OASH Proposed Rule Stage Proposed 1-Year Delay of the General Implementation Date While Allowing the Use of Three Burden-Reducing Provisions During the Delay Year 0937-AA05
HHS/OASH Final Rule Stage Compliance With Title X Requirements By Project Recipients in Selecting Subrecipients 0937-AA04
HHS/CMS Prerule Stage Request for Information: Revisions to Personnel Regulations, Proficiency Testing Referral, Histocompatibility Regulations and Fee Regulations under CLIA (CMS-3326-NC) 0938-AT47
HHS/CMS Proposed Rule Stage Fire Safety Requirements for Certain Dialysis Facilities (CMS-3334-F) 0938-AS94
HHS/CMS Proposed Rule Stage Policy and Technical Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit Programs for Contract Year 2019 (CMS-4182-P) 0938-AT08
HHS/CMS Proposed Rule Stage Third Party Payments for Coverage Under Qualified Health Plans (CMS-3337-P) 0938-AT11
HHS/CMS Proposed Rule Stage CY 2019 Notice of Benefit and Payment Parameters (CMS-9930-P) 0938-AT12
HHS/CMS Proposed Rule Stage Cancellation of Advancing Care Coordination Through Episode Payment and Cardiac Rehabilitation Incentive Payment Models; Changes to Comprehensive Care for Joint Replacement Payment Model (CMS-5524-F) 0938-AT16
HHS/CMS Proposed Rule Stage Expedited Coverage of Innovative Technology (ExCITe) (CMS-3344-P) 0938-AT19
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, (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 Update (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 Administrative Simplification; Health Care Claims Attachments (CMS-0053-P) 0938-AT38
HHS/CMS Proposed Rule Stage Medicare Coverage of Infusion Therapy (CMS-3341-P) 0938-AT39
HHS/CMS Proposed Rule Stage Medicaid and CHIP Managed Care (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-P) 0938-AT41
HHS/CMS Proposed Rule Stage Adoption of a Standard for a Unique Health Plan Identifier Repeal (CMS-0054-P) 0938-AT42
HHS/CMS Proposed Rule Stage Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) Competitive Bidding Program Methodology in Determining Single Payment Amounts (CMS-1699-IFC) 0938-AT43
HHS/CMS Proposed Rule Stage Medicare Shared Savings Program; Accountable Care Organizations (CMS-1701-P) 0938-AT45
HHS/CMS Proposed Rule Stage Short Term Limited Duration Insurance (CMS-9924-P) 0938-AT48
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 Updates to Part D E-Prescribing Standards and Part D HIPAA Electronic Standards (CMS-0055-P) 0938-AT52
HHS/CMS Proposed Rule Stage Exchange Program Integrity (CMS-9922-P) 0938-AT53
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 Changes to the Requirements for Part D Prescribers (CMS-6107-F) 0938-AS60
HHS/CMS Final Rule Stage Medicaid Disproportionate Share Hospital (DSH) Allotment Reductions (CMS-2394-F) 0938-AS63
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-IFC) 0938-AT46
HHS/CMS Final Rule Stage Medicare Shared Savings Program: Addressing Extreme and Uncontrollable Circumstances (CMS–1702–IFC) 0938-AT51
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/ONC Proposed Rule Stage Health Information Technology: Interoperability and Certification Enhancements 0955-AA01
HHS/ACF Prerule Stage Adoption and Foster Care Analysis and Reporting System 0970-AC72
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 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--Exempt Record System for Insider Threat Records 0991-AC10