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Search: Agenda Reg Review ICR
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Agency Rule List - Spring 2014


Department of Health and Human Services

Agency Agenda Stage of Rulemaking Title RIN
HHS/HRSA Proposed 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 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 Proposed Rule Stage 340B Drug Pricing Program Regulations 0906-AB04
HHS/HRSA Proposed Rule Stage Implementation of the HIV Organ Policy Equity (HOPE) Act 0906-AB05
HHS/HRSA Proposed Rule Stage 340B Drug Pricing Program Regulation--AIDS Drug Assistance Programs Rebate Option 0906-AB06
HHS/HRSA Proposed Rule Stage Allowable Uses of Program Income Within the National Hemophilia Program 0906-AB07
HHS/HRSA Final Rule Stage Designation of Medically Underserved Populations and Health Professional Shortage Areas 0906-AA44
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/FDA Prerule Stage FDA Food Safety Modernization Act (FSMA) Amendments to Reportable Food Registry (RFR Requirements) 0910-AG97
HHS/FDA Proposed Rule Stage Food Labeling; Revision of the Nutrition and Supplement Facts Labels 0910-AF22
HHS/FDA Proposed 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 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--Oral Health Care Products 0910-AF40
HHS/FDA Proposed Rule Stage Over-the-Counter (OTC) Drug Review--Sunscreen Products 0910-AF43
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 Produce Safety Regulation 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 "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 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 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 Sanitary Transportation of Human and Animal Food 0910-AG98
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 and General Information Regarding Submission of Information to Support Legal Marketing 0910-AH06
HHS/FDA Proposed Rule Stage Investigational New Drug Application Annual Reporting 0910-AH07
HHS/FDA Proposed 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 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 Administrative Destruction of Certain Drugs Refused Admission to the United States 0910-AH12
HHS/FDA Proposed Rule Stage General and Plastic Surgery Devices: Restriction of Sunlamp Products 0910-AH14
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 Decongestants or Expectorants; 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 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 Postmarketing Safety Reports for Human Drug and Biological Products: Electronic Submission Requirements 0910-AF96
HHS/FDA Final Rule Stage Human Subject Protection; Acceptance of Data From Clinical Studies 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 Use of Certain Symbols in Labeling 0910-AG74
HHS/FDA Final Rule Stage Requirements for the Submission of Data Needed to Calculate User Fees for Domestic Manufacturers and Importers of Tobacco Products 0910-AG81
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 Establishing a List of Qualifying Pathogens That Have the Potential to Pose a Serious Threat to Public Health Under the Food and Drug Administration Safety and Innovation Act 0910-AG92
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/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 Proposed Rule Stage Medical Examination of Aliens 0920-AA28
HHS/CDC Proposed Rule Stage World Trade Center Health Program; Definitions 0920-AA56
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 World Trade Center Health Program; Amendments to List of WTC-Related Health Conditions; Cancer; Revision 0920-AA50
HHS/CDC Final Rule Stage Amendments to Occupational Safety and Health Investigations of Places of Employment 0920-AA51
HHS/CDC Final Rule Stage Administrative Functions, Practices, and Procedures 0920-AA55
HHS/NIH Proposed Rule Stage Undergraduate Scholarship Program Regarding Professions Needed by the National Institutes of Health 0925-AA48
HHS/NIH Proposed Rule Stage Clinical Trials Registration and Results Submission 0925-AA55
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 the Office of the Inspector General's Civil Monetary Penalty Rules 0936-AA04
HHS/OIG Proposed Rule Stage Fraud and Abuse; Revisions to the Office of Inspector General's Exclusion Authorities 0936-AA05
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-P) 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 Medicare Secondary Payer and "Future Medicals" (CMS-6047-P) 0938-AR43
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 and Quality Assurance and Performance Improvement (QAPI) Program (CMS-3260-P) 0938-AR61
HHS/CMS Proposed Rule Stage Fire Safety Requirements for Certain Health Care Facilities (CMS-3277-P) 0938-AR72
HHS/CMS Proposed Rule Stage Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS): Special Payment Rules (CMS-6012-P) 0938-AR84
HHS/CMS Proposed Rule Stage Prior Authorization Process for Certain Durable Medical Equipment, Prosthetic, Orthotics, and Supplies (DMEPOS) Items (CMS-6050-P) 0938-AR85
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 FY 2015 Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities (SNF) (CMS-1605-P) 0938-AS07
HHS/CMS Proposed Rule Stage FY 2015 Inpatient Psychiatric Facilities Prospective Payment System--Rate Update (CMS-1606-P) 0938-AS08
HHS/CMS Proposed Rule Stage FY 2015 Inpatient Rehabilitation Facility Prospective Payment System (CMS-1608-P) 0938-AS09
HHS/CMS Proposed Rule Stage FY 2015 Hospice Payment Rate Update (CMS-1609-P) 0938-AS10
HHS/CMS Proposed Rule Stage Hospital Inpatient Prospective Payment System for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Fiscal Year 2015 Rates (CMS-1607-P) 0938-AS11
HHS/CMS Proposed Rule Stage CY 2015 Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Medicare Part B (CMS-1612-P) 0938-AS12
HHS/CMS Proposed Rule Stage CY 2015 Changes to the End-Stage Renal Disease (ESRD) Prospective Payment System and Quality Incentive Program (CMS-1614-P) 0938-AS13
HHS/CMS Proposed Rule Stage CY 2015 Home Health Prospective Payment System Refinements and Rate Update (CMS-1611-P) 0938-AS14
HHS/CMS Proposed Rule Stage CY 2015 Hospital Outpatient Prospective Payment System (PPS) Policy Changes and Payment Rates, and CY 2015 Ambulatory Surgical Center Payment System Policy Changes and Payment Rates (CMS-1613-P) 0938-AS15
HHS/CMS Proposed Rule Stage Amendments to Excepted Benefits (CMS-9946-F) 0938-AS16
HHS/CMS Proposed Rule Stage CY 2016 Notice of Benefit and Payment Parameters (CMS-9944-P) 0938-AS19
HHS/CMS Proposed Rule Stage Contract Year 2016 Policy and Technical Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit Programs (CMS-4174-P) 0938-AS20
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 Ninety-Day Waiting Period Limitation (CMS-9952-F2) 0938-AS22
HHS/CMS Proposed Rule Stage Transfer of Assets and Post-Eligibility Treatment of Income (CMS-2379-P) 0938-AS23
HHS/CMS Proposed Rule Stage Application of the Mental Health Parity and Addiction Equity Act to Medicaid Programs (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-0042-P) 0938-AS26
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 Medicare Shared Savings Program; Final Waivers (CMS-1439-F) 0938-AR30
HHS/CMS Final Rule Stage Prospective Payment System for Federally Qualified Health Centers; Changes to Contracting Policies for Rural Health Clinics and CLIA Enforcement Actions for Proficiency Testing Referral (CMS-1443-FC) 0938-AR62
HHS/CMS Final Rule Stage CY 2015 Inpatient Hospital Deductible and Hospital and Extended Care Services Coinsurance Amounts (CMS-8056-N) 0938-AR94
HHS/CMS Final Rule Stage CY 2015 Part A Premiums for the Uninsured Aged and for Certain Disabled Individuals Who Have Exhausted Other Entitlement (CMS-8057-N) 0938-AR96
HHS/CMS Final Rule Stage Adoption of Operating Rules for HIPAA Transactions (CMS-0036-IFC) 0938-AS01
HHS/CMS Final Rule Stage Extension of Payment Adjustment for Low-Volume Hospitals and the Medicare-Dependent Hospital Program Under the FY 2014 Hospital Inpatient Prospective Payment System (CMS-1599-IFC2) 0938-AS18
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 Patient Protection and Affordable Care Act; Third Party Payment of Qualified Health Plan (QHP) Premiums (CMS-9943-IFC) 0938-AS28
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 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 Performance Standards for Runaway and Homeless Youth Grantees 0970-AC43
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 Temporary Assistance for Needy Families (TANF) Assistance and Electronic Benefits Transfer Actions 0970-AC56
HHS/ACF Proposed Rule Stage Standards for Data Exchange 0970-AC58
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 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 Implementation of the Unaccompanied Alien Children (UAC) Provisions of the Violence Against Women Reauthorization Act of 2013 0970-AC61
HHS/ACL Final Rule Stage State Long-Term Care 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 2017 Edition Certification Criteria for Health Information Technology 0991-AB93
HHS/OS Proposed Rule Stage Equal Participation of Religious Organizations in HHS Programs and Activities 0991-AB96
HHS/OS Final Rule Stage Amend Health and Human Services Acquisition Regulation (HHSAR), To Add Clauses 352.227-11 and 352.227-14 0991-AB87
HHS/OS Final Rule Stage Voluntary 2015 Edition Electronic Health Record (EHR) Certification Criteria; Interoperability Updates and Regulatory Improvements 0991-AB92
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
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