Agency Rule List - Spring 2019


Department of Health and Human Services

Agency Agenda Stage of Rulemaking Title RIN
HHS/FDA Long-Term Actions Combinations of Bronchodilators With Nasal Decongestant; Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-Counter Human Use 0910-AF33
HHS/FDA Long-Term Actions Over-the-Counter (OTC) Drug Review--External Analgesic Products 0910-AF35
HHS/FDA Long-Term Actions Over-the-Counter (OTC) Drug Review--Internal Analgesic Products 0910-AF36
HHS/FDA Long-Term Actions Over-the-Counter (OTC) Drug Review--Laxative Drug Products 0910-AF38
HHS/FDA Long-Term Actions Over-the-Counter (OTC) Drug Review--Oral Health Care Products 0910-AF40
HHS/FDA Long-Term Actions Over-the-Counter (OTC) Drug Review--Weight Control Products 0910-AF45
HHS/FDA Long-Term Actions Over-the-Counter (OTC) Drug Review--Pediatric Dosing for Cough/Cold Products 0910-AG12
HHS/FDA Long-Term Actions Electronic Distribution of Prescribing Information for Human Prescription Drugs Including Biological Products 0910-AG18
HHS/FDA Long-Term Actions Sunlamp Products; Amendment to the Performance Standard 0910-AG30
HHS/FDA Long-Term Actions Pediatric Study Plan Requirements for New Drug and Biologics License Applications 0910-AG93
HHS/FDA Long-Term Actions Investigational Tobacco Product Applications 0910-AH06
HHS/FDA Long-Term Actions General and Plastic Surgery Devices: Sunlamp Products 0910-AH14
HHS/FDA Long-Term Actions Combinations of Bronchodilators With Expectorants; Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-Counter Human Use 0910-AH16
HHS/FDA Long-Term Actions Acute Nicotine Toxicity Warnings for E-Liquids 0910-AH24
HHS/FDA Long-Term Actions Medical Device De Novo Classification Process 0910-AH53
HHS/FDA Long-Term Actions Establishment Registration and Product Listing for Tobacco Products 0910-AH59
HHS/FDA Long-Term Actions Current Good Manufacturing Practice for Outsourcing Facilities 0910-AH61
HHS/FDA Long-Term Actions Premium Cigars; Request for Scientific Information 0910-AH88
HHS/FDA Long-Term Actions Testing Standards for Batteries and Battery Management Systems in Electronic Nicotine Delivery Systems 0910-AH90
HHS/FDA Long-Term Actions Administration Detention of Tobacco Products 0910-AI05
HHS/CMS Long-Term Actions Revision of Requirements for Long-Term Care Facilities: Arbitration Agreements (CMS-3342-F) 0938-AT18
HHS/CMS Long-Term Actions Durable Medical Equipment Fee Schedule, Adjustments to Resume the Transitional 50/50 Blended Rates to Provide Relief in Non-Competitive Bidding Areas (CMS-1687-F) 0938-AT21
HHS/CMS Long-Term Actions Regulatory Provisions to Promote Program Efficiency, Transparency, and Burden Reduction (CMS-3346-F) 0938-AT23
HHS/CMS Long-Term Actions Clinical Laboratory Improvement Amendments (CLIA) Fees (CMS-3356-P) 0938-AT56
HHS/CMS Long-Term Actions Changes to the Medicare Claims, Medicare Advantage Organization Determination, and Medicare Prescription Drug Coverage Determination Appeals Procedures (CMS-4174-F) 0938-AT62
HHS/CMS Long-Term Actions Non-Emergency Medical Transportation in Medicaid (CMS-2481-P) 0938-AT81
HHS/CMS Long-Term Actions Accrediting Organizations: Conflict of Interest and Consulting Services (CMS-3367-P) 0938-AT84
HHS/CMS Long-Term Actions Modernizing Part D and Medicare Advantage to Lower Drug Prices and Reduce Out of Pocket Expenses (CMS-4180-F) 0938-AT92
HHS/CMS Long-Term Actions Medicaid and Children's Health Insurance Plan (CHIP) Scorecard Initiative (CMS-2419-P) 0938-AT96
HHS/CMS Long-Term Actions Medicaid Payments to States for Ineligible Beneficiaries (CMS-6083-P) 0938-AU03