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Search: Agenda Reg Review ICR
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Agency Rule List - Spring 2016


Department of Health and Human Services

Agency Agenda Stage of Rulemaking Title RIN
HHS/HRSA Proposed Rule Stage Countermeasures Injury Compensation Program; Smallpox Injury Table Amendment 0906-AA84
HHS/HRSA Proposed Rule Stage 340B Drug Pricing Program; Administrative Dispute Resolution Process 0906-AA90
HHS/HRSA Proposed Rule Stage Amendments to the Rule Governing the Operation of the Organ Procurement and Transplantation Network (OPTN) 0906-AA95
HHS/HRSA Final Rule Stage 340(B) Civil Monetary Penalties for Manufacturers and Ceiling Price Regulations 0906-AA89
HHS/HRSA Final Rule Stage Revision to the Vaccine Injury Table Within the National Vaccine Injury Compensation Program 0906-AB01
HHS/HRSA Final Rule Stage Definition of Human Organ Under Section 301 of the National Organ Transplant Act of 1984 0906-AB02
HHS/HRSA Final Rule Stage 340B Program Omnibus Guidelines 0906-AB08
HHS/FDA Proposed Rule Stage Over-the-Counter (OTC) Drug Review--Cough/Cold (Antihistamine) Products 0910-AF31
HHS/FDA Proposed Rule Stage Over-the-Counter (OTC) Drug Review--Topical Antimicrobial Drug Products 0910-AF69
HHS/FDA Proposed Rule Stage Conditional Approval of New Animal Drugs for Minor Use and Minor Species 0910-AG07
HHS/FDA Proposed Rule Stage Updated Standards for Labeling of Pet Food 0910-AG09
HHS/FDA Proposed Rule Stage New Animal Drugs: Updating Tolerances for Residues in New Animal Drugs in Food 0910-AG17
HHS/FDA Proposed Rule Stage Abbreviated New Animal Drug Applications and Phased Review Process for New Animal Drug Applications 0910-AG46
HHS/FDA Proposed Rule Stage Electronic Submission of Labeling for Certain Home-Use Devices 0910-AG79
HHS/FDA Proposed Rule Stage Establishment Registration and Product Listing for Tobacco Products 0910-AG89
HHS/FDA Proposed Rule Stage Pediatric Study Plan Requirements for New Drug and Biologics License Applications 0910-AG93
HHS/FDA Proposed Rule Stage Format and Content of Reports Intended to Demonstrate Substantial Equivalence 0910-AG96
HHS/FDA Proposed Rule Stage Proposal to Ban Powdered Surgeon's Gloves, Powdered Patient Examination Gloves, and Absorbable Powder for Lubricating a Surgeon's Glove 0910-AH02
HHS/FDA Proposed Rule Stage Mammography Quality Standards Act; Regulatory Amendments 0910-AH04
HHS/FDA Proposed Rule Stage Investigational Tobacco Product Applications 0910-AH06
HHS/FDA Proposed Rule Stage Investigational New Drug Application Annual Reporting 0910-AH07
HHS/FDA Proposed Rule Stage Current Good Manufacturing Practice for Outsourcing Facilities 0910-AH09
HHS/FDA Proposed Rule Stage National Standards for Licensing of Prescription Drug Wholesale Distributor and Third-Party Logistics Providers 0910-AH11
HHS/FDA Proposed Rule Stage Requirements for Tobacco Product Manufacturing Practice 0910-AH22
HHS/FDA Proposed Rule Stage Labeling Requirement for Approved and Conditionally Approved New Animal Drugs 0910-AH27
HHS/FDA Proposed Rule Stage Direct Food Substances Affirmed as Generally Recognized as Safe; Partially Hydrogenated Menhaden Oil and Rapeseed Oil 0910-AH28
HHS/FDA Proposed Rule Stage List of Bulk Drug Substances That May Be Used to Compound Drug Products in Accordance With Section 503A of the Federal Food, Drug, and Cosmetic Act 0910-AH29
HHS/FDA Proposed Rule Stage FDA Review and Action on Over-the-Counter Time and Extent Applications 0910-AH30
HHS/FDA Proposed Rule Stage Responsibilities for the Initiation and Conduct of Clinical Investigations 0910-AH32
HHS/FDA Proposed Rule Stage Patient Medication Information 0910-AH33
HHS/FDA Proposed Rule Stage Second 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-AH34
HHS/FDA Proposed Rule Stage Amendments to the Regulation Regarding the List of Drug Products That Have Been Withdrawn or Removed From the Market for Reasons of Safety or Effectiveness 0910-AH35
HHS/FDA Proposed Rule Stage Use of Ozone Depleting Substances 0910-AH36
HHS/FDA Proposed Rule Stage Medical Devices; Internal Agency Review of Decisions; Requests for Review of Medical Device Decisions 0910-AH37
HHS/FDA Proposed Rule Stage Renaming Various Devices as Powered Laparoscopic Tissue Fragmentation Devices; Designation of Special Controls 0910-AH38
HHS/FDA Proposed Rule Stage Ear, Nose, and Throat, Gastroenterology-Urology, General and Plastic Surgery, Neurological, Orthopedic, and Radiology Devices; Reprocessing of Reusable Medical Devices Designation of Special Controls 0910-AH39
HHS/FDA Final Rule Stage Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs That Are Regulated Under a Biologics License Application, and Animal Drugs 0910-AA49
HHS/FDA Final Rule Stage Postmarketing Safety Reporting Requirements for Human Drug and Biological Products 0910-AA97
HHS/FDA Final Rule Stage Medical Gas Containers and Closures; Current Good Manufacturing Practice Requirements 0910-AC53
HHS/FDA Final Rule Stage Food Labeling: Revision of the Nutrition and Supplement Facts Labels 0910-AF22
HHS/FDA Final Rule Stage Food Labeling: Serving Sizes of Foods That Can Reasonably Be Consumed At One Eating Occasion; Dual-Column Labeling; Updating, Modifying, and Establishing Certain RACCs 0910-AF23
HHS/FDA Final Rule Stage Import Tolerances for Residues of Unapproved New Animal Drugs in Food 0910-AF78
HHS/FDA Final Rule Stage Postmarket Safety Reporting for Combination Products 0910-AF82
HHS/FDA Final Rule Stage Abbreviated New Drug Applications and 505(b)(2) 0910-AF97
HHS/FDA Final Rule Stage Amendments to Regulations on Citizen Petitions, Petitions for Stay of Action, and Submission of Documents to Dockets; Implementation of Section 505(q) of the Federal Food, Drug, and Cosmetic Act 0910-AG26
HHS/FDA Final Rule Stage Sunlamp Products; Amendment to the Performance Standard 0910-AG30
HHS/FDA Final Rule Stage "Tobacco Products" Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act 0910-AG38
HHS/FDA Final Rule Stage Reports of Distribution and Sales Information for Antimicrobial Active Ingredients Used in Food-Producing Animals 0910-AG45
HHS/FDA Final Rule Stage Human Subject Protection; Acceptance of Data From Clinical Investigations for Medical Devices 0910-AG48
HHS/FDA Final Rule Stage Focused Mitigation Strategies To Protect Food Against Intentional Adulteration 0910-AG63
HHS/FDA Final Rule Stage Registration of Food Facilities: Amendments to Food Facility Registration Requirements 0910-AG69
HHS/FDA Final Rule Stage Use of Symbols in Labeling 0910-AG74
HHS/FDA Final Rule Stage Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products 0910-AG94
HHS/FDA Final Rule Stage Food Labeling; Gluten-Free Labeling of Fermented, Hydrolyzed, or Distilled Foods 0910-AH00
HHS/FDA Final Rule Stage Additions and Modifications to the List of Drug Products That Have Been Withdrawn or Removed From the Market for Reasons of Safety or Effectiveness 0910-AH08
HHS/FDA Final Rule Stage General and Plastic Surgery Devices: Sunlamp Products 0910-AH14
HHS/FDA Final Rule Stage Substances Generally Recognized as Safe 0910-AH15
HHS/FDA Final Rule Stage Clarification of When Products Made or Derived From Tobacco Are Regulated as Drugs or Devices 0910-AH19
HHS/FDA Final Rule Stage User Fees for FDA's Third-Party Accreditation Program for Food and Feed 0910-AH23
HHS/IHS Final Rule Stage Catastrophic Health Emergency Fund (CHEF) 0917-AA10
HHS/IHS Final Rule Stage Medicare-Like Rate for Non-Hospital Services 0917-AA12
HHS/CDC Proposed Rule Stage World Trade Center Health Program: Amendments to Definitions, Appeals, and Other Requirements 0920-AA56
HHS/CDC Proposed Rule Stage Control of Communicable Diseases 0920-AA63
HHS/CDC Final Rule Stage World Trade Center Health Program Requirements for Enrollment, Appeals, Certification of Health Conditions and Reimbursement 0920-AA44
HHS/CDC Final Rule Stage Specifications for Medical Examinations of Coal Miners 0920-AA57
HHS/CDC Final Rule Stage Possession, Use, and Transfer of Select Agents and Toxins: Addition of HPAI H5N1 Influenza Strains to the List of HHS Select Agents 0920-AA58
HHS/CDC Final Rule Stage Possession, Use, and Transfer of Select Agents and Toxins; Biennial Review, Addition of Certain Influenza Strains to the List of Select Agents, and Enhanced Biosafety Requirements 0920-AA59
HHS/CDC Final Rule Stage World Trade Center Health Program: Addition of New-Onset Chronic Obstructive Pulmonary Disease and Acute Traumatic Injury to the List of WTC-Related Health Conditions 0920-AA61
HHS/NIH Proposed Rule Stage Privacy Act; Exempt Record System for NIH Police Records; Implementation 0925-AA60
HHS/NIH Proposed Rule Stage Privacy Act; Exempt Record System for NIH Division of Loan Repayment Records 0925-AA62
HHS/NIH Proposed Rule Stage Privacy Act; Exempt Record System for NIH Electronic Research Administration (eRA) Records; Implementation 0925-AA63
HHS/NIH Final Rule Stage Clinical Trials Registration and Results Submission 0925-AA55
HHS/SAMHSA Proposed Rule Stage Increase Number of Patients to Which Drug Addiction Treatment Act (DATA)-Waived Physicians Can Prescribe Buprenorphine 0930-AA22
HHS/SAMHSA Final Rule Stage Confidentiality of Substance Use Disorder Patient Records 0930-AA21
HHS/OIG Proposed Rule Stage Medicaid, Revisions to State Medicaid Fraud Control Unit Rules 0936-AA07
HHS/OIG Final Rule Stage Medicare and State Health Care Programs: Fraud and Abuse; Revisions to the Office of the Inspector General's Civil Monetary Penalty Rules 0936-AA04
HHS/OIG Final Rule Stage Fraud and Abuse; Revisions to the Office of Inspector General's Exclusion Authorities 0936-AA05
HHS/OIG Final Rule Stage Medicare and State Health Care Programs: Fraud and Abuse; Revisions to Safe Harbors Under the Anti-Kickback Statute, and Civil Monetary Penalty Rules Regarding Beneficiary Inducements and Gainsharing 0936-AA06
HHS/OASH Final Rule Stage Federal Policy for the Protection of Human Subjects; Final Rules 0937-AA02
HHS/CMS Proposed Rule Stage Programs of All-Inclusive Care for the Elderly (PACE) Update (CMS-4168-P) 0938-AR60
HHS/CMS Proposed Rule Stage Establishment of Special Payment Provisions and Requirements for Qualified Practitioners and Qualified Suppliers of Prosthetics and Custom-Fabricated Orthotics (CMS-6012-P) 0938-AR84
HHS/CMS Proposed Rule Stage Hospital and Critical Access Hospital (CAH) Changes to Promote Innovation, Flexibility, and Improvement in Patient Care (CMS-3295-P) 0938-AS21
HHS/CMS Proposed Rule Stage Medicaid Supplemental Payment and Accountability (CMS-2393-P) 0938-AS61
HHS/CMS Proposed Rule Stage Medicaid Disproportionate Share Hospital (DSH) Allotment Reductions (CMS-2394-P) 0938-AS63
HHS/CMS Proposed Rule Stage Merit-Based Incentive Payment System (MIPS) and Alternative Payment Models (APMs) in Medicare Fee-for-Service (CMS-5517-P) 0938-AS69
HHS/CMS Proposed Rule Stage Changes to the Medicaid Eligibility Quality Control and Payment Error Rate Measurement (PERM) Programs in Response to the Affordable Care Act (CMS-6068-P) 0938-AS74
HHS/CMS Proposed Rule Stage FY 2017 Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities (CMS-1645-F) 0938-AS75
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 2017 Rates (CMS-1655-F) 0938-AS77
HHS/CMS Proposed Rule Stage FY 2017 Inpatient Rehabilitation Facility Prospective Payment System (CMS-1647-F) 0938-AS78
HHS/CMS Proposed Rule Stage FY 2017 Hospice Rate Update (CMS-1652-F) 0938-AS79
HHS/CMS Proposed Rule Stage CY 2017 Home Health Prospective Payment System Rate Update; Home Health Value-Based Purchasing Model; and Home Health Quality Reporting Requirements 0938-AS80
HHS/CMS Proposed Rule Stage CY 2017 Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Medicare Part B (CMS-1654-P) 0938-AS81
HHS/CMS Proposed Rule Stage CY 2017 Hospital Outpatient PPS Policy Changes and Payment Rates and Ambulatory Surgical Center Payment System Policy Changes and Payment Rates (CMS-1656-P) 0938-AS82
HHS/CMS Proposed Rule Stage CY 2017 Changes to the End-Stage Renal Disease (ESRD) Prospective Payment System and Quality Incentive, Durable Medical Equipment, and DMEPOS Competitive Bidding Programs (CMS-1651-P) 0938-AS83
HHS/CMS Proposed Rule Stage Part B Drug Payment Model (CMS-1670-F) 0938-AS85
HHS/CMS Proposed Rule Stage Advancing Care Coordination (CMS-5519-P) 0938-AS90
HHS/CMS Final Rule Stage Emergency Preparedness Requirements for Medicare and Medicaid Participating Providers and Suppliers (CMS-3178-F) 0938-AO91
HHS/CMS Final Rule Stage Reform of Requirements for Long-Term Care Facilities (CMS-3260-F) 0938-AR61
HHS/CMS Final Rule Stage Obtaining Final Medicare Secondary Payer Conditional Payment Amounts via Web Portal (CMS-6054-F) 0938-AR90
HHS/CMS Final Rule Stage Flexibility, Efficiency, and Modernization in Child Support Enforcement Programs (CMS-2343-F) 0938-AR92
HHS/CMS Final Rule Stage Prior Authorization of Certain Chiropractic Services For Certain Chiropractors (CMS-6070-IFC) 0938-AS68
HHS/CMS Final Rule Stage CY 2017 Inpatient Hospital Deductible and Hospital and Extended Care Services Coinsurance Amounts (CMS-8062-N) 0938-AS70
HHS/CMS Final Rule Stage CY 2017 Part A Premiums for the Uninsured Aged and for Certain Disabled Individuals Who Have Exhausted Other Entitlement (CMS-8063-N) 0938-AS71
HHS/CMS Final Rule Stage CY 2017 Part B Monthly Actuarial Rates, Monthly Premium Rates, and Annual Deductible (CMS-8064-N) 0938-AS72
HHS/CMS Final Rule Stage FY 2017 Inpatient Psychiatric Facilities Prospective Payment System--Rate Update (CMS-1650-N) 0938-AS76
HHS/CMS Final Rule Stage Amendments to the Consumer Operated and Oriented Plan Program Regulations (CMS-9933-IFC) 0938-AS87
HHS/OCR Prerule Stage HIPAA Enforcement: Distribution of a Percentage of Civil Money Penalties or Monetary Settlements to Harmed Individuals 0945-AA04
HHS/OCR Final Rule Stage Nondiscrimination Under the Patient Protection and Affordable Care Act 0945-AA02
HHS/ONC Proposed Rule Stage ONC Health IT Certification Program: Enhanced Oversight and Accountability 0955-AA00
HHS/ACF Prerule Stage Adoption and Foster Care Analysis and Reporting System (AFCARS) 0970-AC68
HHS/ACF Proposed Rule Stage Implementation of the Unaccompanied Alien Children (UAC) Provisions of the Trafficking Victims Reauthorization Act of 2008 0970-AC42
HHS/ACF Final Rule Stage Performance Standards for Runaway and Homeless Youth Grantees 0970-AC43
HHS/ACF Final Rule Stage Adoption and Foster Care Analysis and Reporting System (AFCARS) 0970-AC47
HHS/ACF Final Rule Stage Flexibility, Efficiency, and Modernization of Child Support Enforcement Programs 0970-AC50
HHS/ACF Final Rule Stage Statewide Automated Child Welfare Information Systems (SACWIS) 0970-AC59
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 Family Violence Prevention and Services Program Regulation 0970-AC62
HHS/ACF Final Rule Stage Head Start Performance Standards 0970-AC63
HHS/ACF Final Rule Stage Child Care and Development Block Grant Act of Reauthorization Implementation 0970-AC67
HHS/ACL Final Rule Stage Independent Living Services and Centers for Independent Living 0985-AA10
HHS/ACL Final Rule Stage State Health Insurance Assistance Program 0985-AA11
HHS/ACL Final Rule Stage National Institute on Disability, Independent Living, and Rehabilitation Research 0985-AA12
HHS/OS Proposed Rule Stage Medicare Program; Changes to the Medicare Claims and Entitlement, Medicare Advantage Organization Determination, and Medicare Prescription Drug Coverage Determination Appeals Procedures 0991-AC02
HHS/OS Proposed Rule Stage Freedom of Information Regulations 0991-AC04
HHS/OS Final Rule Stage Revise, Update, and Re-Issue HHS Grants Administration Regulations 0991-AB94
HHS/OS Final Rule Stage Health Resources Priority and Allocations System (HRPAS) 0991-AB95
HHS/OS Final Rule Stage Equal Participation of Religious Organizations in HHS Programs and Activities 0991-AB96
HHS/OS Final Rule Stage Notice of Proposed Rulemaking (NPRM) for Additional Provisions to HHS Grants Regulations 0991-AC06
HHS/OS Final Rule Stage Interim Final Rule Implementing the Federal Civil Monetary Penalties Inflation Adjustment Act Improvements of 2015 0991-AC07
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