Agency Rule List - Fall 2014


Department of Health and Human Services

Agency Agenda Stage of Rulemaking Title RIN
HHS/HRSA Proposed Rule Stage 340B Civil Monetary Penalties for Manufacturers and Ceiling Price Regulations 0906-AA89
HHS/HRSA Proposed Rule Stage 340B Drug Pricing Program; Administrative Dispute Resolution Process 0906-AA90
HHS/HRSA Proposed Rule Stage Teaching Health Center Graduate Medical Education Program 0906-AA98
HHS/HRSA Proposed Rule Stage Revision to the Vaccine Injury Table Within the National Vaccine Injury Compensation Program 0906-AB01
HHS/HRSA Proposed Rule Stage Improve Efficiency and Integrity of the National Health Service Corps Program 0906-AB03
HHS/HRSA Final Rule Stage Designation of Medically Underserved Populations and Health Professional Shortage Areas 0906-AA44
HHS/HRSA Final Rule Stage Countermeasures Injury Compensation Program; Pandemic Influenza Countermeasure Injury Table Amendment for Influenza Vaccines, Antiviral Drugs, Respiratory Protection/Support Devices, and Diagnostics 0906-AA79
HHS/HRSA Final Rule Stage Vaccine Injury Table: Rotavirus Vaccine Within the National Vaccine Injury Compensation Program 0906-AB00
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 Implementation of the HIV Organ Policy Equity (HOPE) Act 0906-AB05
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--Internal Analgesic Products 0910-AF36
HHS/FDA Proposed Rule Stage Over-the-Counter (OTC) Drug Review--Topical Antimicrobial Drug Products 0910-AF69
HHS/FDA Proposed Rule Stage Abbreviated New Drug Applications and 505(b)(2) 0910-AF97
HHS/FDA Proposed Rule Stage Updated Standards for Labeling of Pet Food 0910-AG09
HHS/FDA Proposed Rule Stage Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals 0910-AG10
HHS/FDA Proposed Rule Stage Over-the-Counter (OTC) Drug Review--Pediatric Dosing for Cough/Cold Products 0910-AG12
HHS/FDA Proposed Rule Stage Electronic Distribution of Prescribing Information for Human Prescription Drugs Including Biological Products 0910-AG18
HHS/FDA Proposed Rule Stage Sunlamp Products; Proposed Amendment to the Performance Standard 0910-AG30
HHS/FDA Proposed Rule Stage Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption 0910-AG35
HHS/FDA Proposed Rule Stage Current Good Manufacturing and Hazard Analysis, and Risk-Based Preventive Controls for Human Food 0910-AG36
HHS/FDA Proposed Rule Stage Reports of Distribution and Sales Information for Antimicrobial Active Ingredients Used in Food-Producing Animals 0910-AG45
HHS/FDA Proposed Rule Stage Requirements for the Testing and Reporting of Tobacco Product Constituents, Ingredients, and Additives 0910-AG59
HHS/FDA Proposed Rule Stage Foreign Supplier Verification Program 0910-AG64
HHS/FDA Proposed Rule Stage Registration of Food Facilities: Amendments to Food Facility Registration Requirements 0910-AG69
HHS/FDA Proposed Rule Stage Submission of Labels and Package Inserts for Medical Devices Listed Pursuant to Section 510(j) of the Federal Food, Drug, and Cosmetic Act 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 Food Labeling; Gluten-Free Labeling of Fermented, Hydrolyzed, or Distilled Foods 0910-AH00
HHS/FDA Proposed Rule Stage Proposal to Ban Powdered Natural Rubber Latex and Powdered Synthetic Latex Surgeon's and Patient Examination Gloves 0910-AH02
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 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 Regulations on Human Drug Compounding Under Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act 0910-AH10
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 General and Plastic Surgery Devices: Sunlamp Products 0910-AH14
HHS/FDA Proposed Rule Stage Clarification of When Products Made or Derived From Tobacco Are Regulated as Drugs or Devices 0910-AH19
HHS/FDA Proposed Rule Stage Revocation of the General Safety Test Regulations That Are Duplicative of Requirements in Biologic License Applications 0910-AH21
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 Content and Format of Labeling for Human Prescription Drugs and Biologics; Requirements for Pregnancy and Lactation Labeling 0910-AF11
HHS/FDA Final Rule Stage Combinations of Bronchodilators With Nasal Decongestant; Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-Counter Human Use 0910-AF33
HHS/FDA Final Rule Stage Over-the-Counter (OTC) Drug Review--Laxative Drug Products 0910-AF38
HHS/FDA Final Rule Stage Use of Materials Derived From Cattle in Human Food and Cosmetics 0910-AF47
HHS/FDA Final Rule Stage Postmarket Safety Reporting for Combination Products 0910-AF82
HHS/FDA Final Rule Stage Laser Products; Amendment to Performance Standard 0910-AF87
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 Human Subject Protection; Acceptance of Data From Clinical Investigations for Medical Devices 0910-AG48
HHS/FDA Final Rule Stage Food Labeling: Calorie Labeling of Articles of Food Sold in Vending Machines 0910-AG56
HHS/FDA Final Rule Stage Food Labeling: Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments 0910-AG57
HHS/FDA Final Rule Stage Accreditation of Third-Party Auditors/Certification Bodies to Conduct Food Safety Audits and to Issue Certifications 0910-AG66
HHS/FDA Final Rule Stage Use of Certain Symbols in Labeling 0910-AG74
HHS/FDA Final Rule Stage Blood Initiative--Requirements for Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use 0910-AG87
HHS/FDA Final Rule Stage Revision of Postmarketing Reporting Requirements Discontinuance or Interruption in Supply of Certain Products (Drug Shortages) 0910-AG88
HHS/FDA Final Rule Stage Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products 0910-AG94
HHS/FDA Final Rule Stage Veterinary Feed Directive 0910-AG95
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 Administrative Destruction of Certain Drugs Refused Admission to the United States 0910-AH12
HHS/FDA Final Rule Stage Combinations of Bronchodilators With Expectorants; Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-Counter Human Use 0910-AH16
HHS/IHS Proposed Rule Stage Catastrophic Health Emergency Fund (CHEF) 0917-AA10
HHS/IHS Proposed Rule Stage Medicare-Like Rate for Non-Hospital Services 0917-AA12
HHS/CDC Prerule Stage Possession, Use, and Transfer of Select Agents and Toxins; Biennial Review 0920-AA59
HHS/CDC Proposed Rule Stage Medical Examination of Aliens 0920-AA28
HHS/CDC Proposed Rule Stage World Trade Center Health Program: Definitions 0920-AA56
HHS/CDC Proposed 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 Proposed Rule Stage World Trade Center Health Program: Addition of COPD and Traumatic Injury to the List of WTC-Related Health Conditions 0920-AA61
HHS/CDC Final Rule Stage Respirator Certification Fees 0920-AA42
HHS/CDC Final Rule Stage World Trade Center Health Program Requirements for Enrollment, Appeals, Certification of Health Conditions Reimbursement 0920-AA44
HHS/CDC Final Rule Stage Administrative Functions, Practices, and Procedures 0920-AA55
HHS/CDC Final Rule Stage Closed-Circuit Escape Respirators; Extension of Transition Period 0920-AA60
HHS/NIH Proposed Rule Stage Clinical Trials Registration and Results Submission 0925-AA55
HHS/NIH Final Rule Stage Undergraduate Scholarship Program Regarding Professions Needed by the National Institutes of Health 0925-AA48
HHS/NIH Final Rule Stage Privacy Act; Exempt Record System for NIH Police Records; Implementation 0925-AA60
HHS/NIH Final Rule Stage Endowments Program 0925-AA61
HHS/SAMHSA Proposed Rule Stage SAMHSA User Fees for Data Requests 0930-AA17
HHS/SAMHSA Proposed Rule Stage SAMHSA User Fees for Publications 0930-AA18
HHS/SAMHSA Proposed Rule Stage SAMHSA Confidentiality of Alcohol and Drug Abuse Patient Records 0930-AA19
HHS/OIG Proposed 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 Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators 0937-AA02
HHS/CMS Proposed Rule Stage Home Health Agency Conditions of Participation (CMS-3819-F) 0938-AG81
HHS/CMS Proposed Rule Stage State Option To Provide Health Homes for Enrollees With Chronic Conditions (CMS-2331-P) 0938-AQ48
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 Reform of Requirements for Long-Term Care Facilities (CMS-3260-P) 0938-AR61
HHS/CMS Proposed Rule Stage Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DM EPOS): Special Payment Rules (CMS-6012-P) 0938-AR84
HHS/CMS Proposed Rule Stage Civil Money Penalties Under the Medicare, Medicaid, and SCHIP Extension Act of 2007 (MMSEA) (CMS-6061-P) 0938-AR88
HHS/CMS Proposed Rule Stage Modifications to E-Prescribing and Pharmacy Administrative Simplification Transaction Standards (CMS-0039-P) 0938-AR97
HHS/CMS Proposed Rule Stage Clinical Laboratory Improvement Amendments (CLIA); Fecal Occult Blood (FOB) Testing (CMS-3271-P) 0938-AS04
HHS/CMS Proposed Rule Stage Medicare Shared Savings Program; Accountable Care Organizations (CMS-1461-P) 0938-AS06
HHS/CMS Proposed Rule Stage CY 2016 Notice of Benefit and Payment Parameters (CMS-9944-P) 0938-AS19
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 Transfer of Assets and Post-Eligibility Treatment of Income (CMS-2379-P) 0938-AS23
HHS/CMS Proposed Rule Stage Mental Health Parity and Addiction Equity Act of 2008; the Application to Medicaid Managed Care, CHIP, and Alternative Benefit Plans (CMS-2333-P) 0938-AS24
HHS/CMS Proposed Rule Stage Medicaid Managed Care (CMS-2390-P) 0938-AS25
HHS/CMS Proposed Rule Stage Electronic Health Record (EHR) Incentive Programs--Stage 3 (CMS-3310-P) 0938-AS26
HHS/CMS Proposed Rule Stage Revisions to Patient's Rights Conditions for Participation and Conditions for Coverage (CMS-3302-P) 0938-AS29
HHS/CMS Proposed Rule Stage Medicare Clinical Diagnostic Laboratory Test Payment System (CMS-1621-P) 0938-AS33
HHS/CMS Proposed Rule Stage FY 2016 Hospice Rate Update (CMS-1629-P) 0938-AS39
HHS/CMS Proposed Rule Stage CY 2016 Revisions to Payment Policies under the Physician Fee Schedule and Other Revisions to Medicare Part B (CMS-1631-P) 0938-AS40
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 2016 Rates (CMS-1632-P) 0938-AS41
HHS/CMS Proposed Rule Stage CY 2016 Hospital Outpatient PPS Policy Changes and Payment Rates and Ambulatory Surgical Center Payment System Policy Changes and Payment Rates (CMS-1633-P) 0938-AS42
HHS/CMS Proposed Rule Stage FY 2016 Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities (CMS-1622-P) 0938-AS44
HHS/CMS Proposed Rule Stage FY 2016 Inpatient Rehabilitation Facility Prospective Payment System (CMS-1624-P) 0938-AS45
HHS/CMS Proposed Rule Stage CY 2016 Home Health Prospective Payment System Refinements and Rate Update (CMS-1625-P) 0938-AS46
HHS/CMS Proposed Rule Stage FY 2016 Inpatient Psychiatric Facilities Prospective Payment System--Rate Update (CMS-1627-P) 0938-AS47
HHS/CMS Proposed Rule Stage CY 2016 Changes to the End-Stage Renal Disease (ESRD) Prospective Payment System and Quality Incentive Program (CMS-1628-P) 0938-AS48
HHS/CMS Proposed Rule Stage Coverage of Certain Preventive Services; Eligible Organizations (CMS-9940-P) 0938-AS50
HHS/CMS Final Rule Stage Face-to-Face Requirements for Home Health Services; Policy Changes and Clarifications Related to Home Health (CMS-2348-F) 0938-AQ36
HHS/CMS Final Rule Stage Medicaid Disproportionate Share Hospital Payments Uninsured Definition (CMS-2315-F) 0938-AQ37
HHS/CMS Final Rule Stage Covered Outpatient Drugs (CMS-2345-F) 0938-AQ41
HHS/CMS Final Rule Stage Methods for Assuring Access to Covered Medicaid Services (CMS-2328-F) 0938-AQ54
HHS/CMS Final Rule Stage Reporting and Returning of Overpayments (CMS-6037-F) 0938-AQ58
HHS/CMS Final Rule Stage Administrative Simplification: Certification of Compliance for Health Plans (CMS-0037-F) 0938-AQ85
HHS/CMS Final Rule Stage Contract Year 2015 Policy and Technical Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit Programs; Remaining Provisions (CMS-4159-F2) 0938-AS20
HHS/CMS Final Rule Stage Eligibility Notices, Fair Hearing and Appeal Processes for Medicaid and Exchange Eligibility Appeals, and Other Eligibility and Enrollment Provisions (CMS-2334-F2) 0938-AS27
HHS/CMS Final Rule Stage CY 2016 Inpatient Hospital Deductible and Hospital and Extended Care Services Coinsurance Amounts (CMS-8059-N) 0938-AS36
HHS/CMS Final Rule Stage CY 2016 Part A Premiums for the Uninsured Aged and for Certain Disabled Individuals Who Have Exhausted Other Entitlement (CMS-8060-N) 0938-AS37
HHS/CMS Final Rule Stage CY 2016 Part B Monthly Actuarial Rates, Monthly Premium Rates, and Annual Deductible (CMS-8061-N) 0938-AS38
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 Nondiscrimination Under the Patient Protection and Affordable Care Act 0945-AA02
HHS/OCR Proposed Rule Stage Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule; Modifications to Ensure the Equal Rights of Same-Sex Spouses 0945-AA07
HHS/OCR Final Rule Stage HIPAA Privacy Rule and the National Instant Criminal Background Check System (NICS) 0945-AA05
HHS/ACF Prerule Stage Revisions and Amendments to Regulations Governing Native American Programs authorized Under the Native American Programs Act of 1974 0970-AC60
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 Adoption and Foster Care Analysis and Reporting System (AFCARS) 0970-AC47
HHS/ACF Proposed Rule Stage Flexibility, Efficiency, and Modernization of Child Support Enforcement Programs 0970-AC50
HHS/ACF Proposed Rule Stage Standards for Data Exchange 0970-AC58
HHS/ACF Proposed Rule Stage Statewide Automated Child Welfare Information Systems (SACWIS) 0970-AC59
HHS/ACF Proposed Rule Stage Family Violence Prevention and Services Program Regulation 0970-AC62
HHS/ACF Proposed Rule Stage Head Start Performance Standards 0970-AC63
HHS/ACF Proposed Rule Stage Refugee Medical Assistance 0970-AC64
HHS/ACF Final Rule Stage Performance Standards for Runaway and Homeless Youth Grantees 0970-AC43
HHS/ACF Final Rule Stage Head Start Eligibility Determination 0970-AC46
HHS/ACF Final Rule Stage Child Care and Development Fund Reforms to Support Child Development and Working Families 0970-AC53
HHS/ACF Final Rule Stage Temporary Assistance for Needy Families (TANF) Assistance and Electronic Benefits Transfer Actions 0970-AC56
HHS/ACF Final Rule Stage Implementation of the Unaccompanied Alien Children (UAC) Provisions of the Violence Against Women Reauthorization Act of 2013 0970-AC61
HHS/ACF Final Rule Stage Removal of Child Abuse Prevention and Treatment Act (CAPTA) Regulations 0970-AC65
HHS/ACL Proposed Rule Stage Independent Living Program Revisions in Support of the Workforce Innovation and Opportunity Act 0985-AA10
HHS/ACL Proposed Rule Stage State Health Insurance Assistance Programs Conforming Changes 0985-AA11
HHS/ACL Proposed Rule Stage Disability and Rehabilitation Research Projects and Centers Program; Disability and Rehabilitation Research; Research Fellowships; Special Projects and Demonstrations for Spinal Cord Injuries 0985-AA12
HHS/ACL Final Rule Stage Older Americans Act--Ombudsman Program 0985-AA08
HHS/ACL Final Rule Stage Developmental Disabilities Assistance and Bill of Rights 0985-AA09
HHS/OS Proposed Rule Stage Revise, Update, and Reissue Health and Human Services Acquisition Regulation (HHSAR) 0991-AB86
HHS/OS Proposed Rule Stage 2015 Edition Health Information Technology (Health IT) Certification Criteria, Base Electronic Health Record (EHR) Definition, and ONC Health IT Certification Program Modifications 0991-AB93
HHS/OS Proposed Rule Stage Equal Participation of Religious Organizations in HHS Programs and Activities 0991-AB96
HHS/OS Proposed Rule Stage Organizational Integrity of Entities Implementing Programs and Activities Under the Leadership Act 0991-AC00
HHS/OS Final Rule Stage HHS Uniform Administrative Requirements for Grant and Cooperative Agreement Awards and Subawards 0991-AB94
HHS/OS Final Rule Stage Health Resources Priority and Allocations System (HRPAS) 0991-AB95
HHS/OS Final Rule Stage Removal of Obsolete Provisions From the CFR 0991-AB98