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


Department of Health and Human Services

Agency Agenda Stage of Rulemaking Title RIN
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 Removing Outmoded Regulations Regarding the Smallpox Vaccine Injury Compensation Program 0906-AA84
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 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 Format and Content of Reports Intended To Demonstrate Substantial Equivalence 0910-AG96
HHS/FDA Proposed Rule Stage Radiology Devices; Designation of Special Controls for the Computed Tomography X-Ray System 0910-AH03
HHS/FDA Proposed Rule Stage Mammography Quality Standards Act; Regulatory Amendments 0910-AH04
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 Licensure of Wholesale Distributors 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 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 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 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 Proposed Rule Stage Food Labeling: Calorie Labeling of Articles of Food in Vending Machines; Front of Package Font Size and Signage for Gums, Mints and Roll Candy Sold From Vending Machines 0910-AH42
HHS/FDA Proposed Rule Stage Food Labeling: Health Claims; Soy Protein and Coronary Heart Disease 0910-AH43
HHS/FDA Proposed Rule Stage Premarket Tobacco Product Applications 0910-AH44
HHS/FDA Proposed Rule Stage Record-keeping Requirements for Certain Submissions to FDA 0910-AH45
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 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 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 Human Subject Protection; Acceptance of Data From Clinical Investigations for Medical Devices 0910-AG48
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 Banned Powdered Surgeon's Gloves, Powdered Patient Examination Gloves, and Absorbable Powder for Lubricating a Surgeon's Glove 0910-AH02
HHS/FDA Final Rule Stage General and Plastic Surgery Devices: Sunlamp Products 0910-AH14
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/FDA Final Rule Stage FDA Review and Action on Over-the-Counter Time and Extent Applications 0910-AH30
HHS/FDA Final Rule Stage Submission of Food and Drug Administration Import Data in the Automated Commercial Environment 0910-AH41
HHS/IHS Final Rule Stage Catastrophic Health Emergency Fund (CHEF) 0917-AA10
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 World Trade Center Health Program: Amendments to Definitions, Appeals, and Other Requirements 0920-AA56
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 Control of Communicable Diseases 0920-AA63
HHS/CDC Final Rule Stage Possession, Use, and Transfer of Select Agents and Toxins ? Addition of Bacillus cereus Biovar anthracis to the HHS List of Select Agents and Toxins 0920-AA64
HHS/NIH Prerule Stage National Institutes of Health Construction Grants 0925-AA64
HHS/NIH Final Rule Stage Privacy Act; Exempt Record System for NIH Police Records; Implementation 0925-AA60
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 Tobacco Regulation for Substance Abuse Prevention and Treatment Block Grants 0930-AA20
HHS/SAMHSA Proposed Rule Stage Medication Assisted Treatment for Opioid Use Disorders--Nurse Practitioners and Physician Assistants 0930-AA25
HHS/SAMHSA Final Rule Stage Confidentiality of Substance Use Disorder Patient Records 0930-AA21
HHS/SAMHSA Final Rule Stage Medication Assisted Treatment for Opioid Use Disorders Reporting Requirements 0930-AA22
HHS/SAMHSA Final Rule Stage Substance Abuse and Mental Health Services Administration Mandatory Guidelines for Federal Workplace Drug Testing Programs 0930-AA23
HHS/SAMHSA Final Rule Stage Substance Abuse and Mental Health Services Administration Mandatory Guidelines for Federal Workplace Drug Testing Programs 0930-AA24
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 Proposed Rule Stage Compliance With Title X Requirements by Project Recipients in Selecting Subrecipients 0937-AA04
HHS/OASH Final Rule Stage Federal Policy for the Protection of Human Subjects; Final Rules 0937-AA02
HHS/CMS Proposed Rule Stage Administrative Simplification: Certification of Compliance for Health Plans (CMS-0037-P2) 0938-AQ85
HHS/CMS Proposed Rule Stage Programs of All-Inclusive Care for the Elderly (PACE) Update (CMS-4168-F) 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 Modification to National Council for Prescription Drug Programs (NCPDP) Telecommunication Standard Implementation Guide Version D.0 Enhancement (CMS-0039-P) 0938-AR97
HHS/CMS Proposed Rule Stage Adoption of Operating Rules for HIPAA Transactions (CMS-0036-P) 0938-AS01
HHS/CMS Proposed Rule Stage Post-Eligibility Treatment of Income, Appeal Processes for Medicaid, and Other Provisions Related to Eligibility and Enrollment for Medicaid and CHIP (CMS-2379-P) 0938-AS23
HHS/CMS Proposed 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-P2) 0938-AS55
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 Prior Authorization of Certain Chiropractic Services for Certain Chiropractors (CMS-6070-IFC) 0938-AS68
HHS/CMS Proposed Rule Stage Fire Safety Requirements for Certain Dialysis Facilities (CMS-3334-P) 0938-AS94
HHS/CMS Proposed Rule Stage FY 2018 Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities (SNFs) (CMS-1679-P) 0938-AS96
HHS/CMS Proposed Rule Stage FY 2018 Inpatient Psychiatric Facilities Prospective Payment System--Rate Update (CMS-1673-P) 0938-AS97
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 2018 Rates (CMS-1677-P) 0938-AS98
HHS/CMS Proposed Rule Stage FY 2018 Inpatient Rehabilitation Facility (IRF) Prospective Payment System (CMS-1671-P) 0938-AS99
HHS/CMS Proposed Rule Stage FY 2018 Hospice Rate Update (CMS-1675-P) 0938-AT00
HHS/CMS Proposed Rule Stage CY 2018 Home Health Prospective Payment System Rate Update (CMS-1672-P) 0938-AT01
HHS/CMS Proposed Rule Stage CY 2018 Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Medicare Part B (CMS-1676-P) 0938-AT02
HHS/CMS Proposed Rule Stage CY 2018 Hospital Outpatient PPS Policy Changes and Payment Rates and Ambulatory Surgical Center Payment System Policy Changes and Payment Rates (CMS-1678-P) 0938-AT03
HHS/CMS Proposed Rule Stage CY 2018 Changes to the End-Stage Renal Disease (ESRD) Prospective Payment System, Quality Incentive Program, and Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) (CMS-1674-P) 0938-AT04
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 The Use of New or Increased Pass-Through Payments in Medicaid Managed Care Delivery Systems (CMS-2402-P) 0938-AT10
HHS/CMS Final Rule Stage Flexibility, Efficiency, and Modernization in Child Support Enforcement Programs (CMS-2343-F) 0938-AR92
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-F2) 0938-AS27
HHS/CMS Final Rule Stage Merit-Based Incentive Payment System (MIPS) and Alternative Payment Models (APMs) in Medicare Fee-for-Service (CMS-5517-FC) 0938-AS69
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 Changes to the Medicaid Eligibility Quality Control and Payment Error Rate Measurement (PERM) Programs in Response to the Affordable Care Act (CMS-6068-F) 0938-AS74
HHS/CMS Final Rule Stage CY 2017 Home Health Prospective Payment System Rate Update; Home Health Value-Based Purchasing Model; and Home Health Quality Reporting Requirements (CMS-1648-F) 0938-AS80
HHS/CMS Final Rule Stage CY 2017 Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Medicare Part B (CMS-1654-F) 0938-AS81
HHS/CMS Final 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-FC) 0938-AS82
HHS/CMS Final Rule Stage CY 2017 Changes to the End-Stage Renal Disease (ESRD) Prospective Payment System, Quality Incentive Program, and Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) (CMS-1651-F) 0938-AS83
HHS/CMS Final Rule Stage Disproportionate Share Hospital (DSH) Payments: Treatment of Third Party Payers in Calculating Uncompensated Costs (CMS-2399-F) 0938-AS92
HHS/CMS Final Rule Stage Expatriate Health Plans, Expatriate Health Plan Issuers, and Qualified Expatriates; Excepted Benefits; Lifetime and Annual Limits; and Short-Term, Limited-Duration Insurance (CMS-9932-F) 0938-AS93
HHS/CMS Final Rule Stage CY 2018 Notice of Benefit and Payment Parameters (CMS-9934-P) 0938-AS95
HHS/CMS Final Rule Stage CY 2018 Inpatient Hospital Deductible and Hospital and Extended Care Services Coinsurance Amounts (CMS-8065-N) 0938-AT05
HHS/CMS Final Rule Stage CY 2018 Part A Premiums for the Uninsured Aged and for Certain Disabled Individuals Who Have Exhausted Other Entitlement (CMS-8066-N) 0938-AT06
HHS/CMS Final Rule Stage CY 2018 Part B Monthly Actuarial Rates, Monthly Premium Rates, and Annual Deductible (CMS-8067-N) 0938-AT07
HHS/CMS Final Rule Stage Conditions for Coverage for End-Stage Renal Disease Facilities (CMS-3337-IFC) 0938-AT11
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 Proposed Rule Stage Standards for Data Exchange 0970-AC58
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 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/OS Prerule Stage Privacy Act Regulations 0991-AC05
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
HHS/OS Final Rule Stage Removal of 2 CFR Subsection 376.147 0991-AC08
HHS/OS Final Rule Stage Uniform Administrative Requirements, Costs Principles and Adult Requirements (45 CFR 75) 0991-AC09
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