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Search: Agenda Reg Review ICR

Agency Rule List - Fall 2013

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 Countermeasures Injury Compensation Program; Smallpox Injury Table Amendment 0906-AA84
HHS/HRSA Proposed Rule Stage Teaching Health Center Graduate Medical Education Program 0906-AA98
HHS/HRSA Proposed Rule Stage Vaccine Injury Table: Rotavirus Vaccine Within the National Vaccine Injury Compensation Program 0906-AB00
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 Definition of Human Organ Under Section 301 of the National Organ Transplant Act of 1984 0906-AB02
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 Final Rule Stage Designation of Medically Underserved Populations and Health Professional Shortage Areas 0906-AA44
HHS/FDA Prerule Stage Over-the-Counter (OTC) Drug Review--Sunscreen Products 0910-AF43
HHS/FDA Prerule Stage Prescription Drug Marketing Act of 1987; Prescription Drug Amendments of 1992; Policies, Requirements, and Administrative Procedures 0910-AG14
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 Abbreviated New Drug Applications and 505(b)(2) Applications 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, 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 Hazard Analysis and Risk-Based Preventive Controls 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 Focused Mitigation Strategies To Protect Food Against Intentional Adulteration 0910-AG63
HHS/FDA Proposed Rule Stage Foreign Supplier Verification Program 0910-AG64
HHS/FDA Proposed Rule Stage Accreditation of Third Parties To Conduct Food Safety Audits and For Other Related Purposes 0910-AG66
HHS/FDA Proposed Rule Stage Registration of Food Facilities: Amendments to Food Facility Registration Requirements 0910-AG69
HHS/FDA Proposed Rule Stage Revision of Postmarketing Reporting Requirements Discontinuance or Interruption in Supply of Certain Products (Drug Shortages) 0910-AG88
HHS/FDA Proposed Rule Stage Establishment Registration and Product Listing for Tobacco Products 0910-AG89
HHS/FDA Proposed Rule Stage Public Information in Tobacco Marketing Applications 0910-AG90
HHS/FDA Proposed Rule Stage Pediatric Study Plan Requirements for New Drug and Biologics License Applications 0910-AG93
HHS/FDA Proposed Rule Stage Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products 0910-AG94
HHS/FDA Proposed Rule Stage Veterinary Feed Directive 0910-AG95
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 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 Infant Formula: Current Good Manufacturing Practices; Quality Control Procedures; Notification Requirements; Records and Reports; and Quality Factors 0910-AF27
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 Postmarket Safety Reporting for Combination Products 0910-AF82
HHS/FDA Final Rule Stage Medical Device Reporting; Electronic Submission Requirements 0910-AF86
HHS/FDA Final Rule Stage Laser Products; Proposed 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 Requirement for Submission of Information on Pediatric Subpopulations That Suffer From a Disease or Condition That a Device Is Intended To Treat, Diagnose, or Cure 0910-AG29
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 Establishment, Maintenance, and Availability of Records: Amendment to Record Availability Requirements 0910-AG73
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 Manufacturers and Importers of Tobacco Products 0910-AG81
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/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/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/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/OIG Final Rule Stage Medicare and State Health Care Programs: Fraud and Abuse; Electronic Health Records Safe Harbor Under the Anti-Kickback Statute 0936-AA03
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 Prerule Stage Civil Money Penalties Under the Medicare, Medicaid, and SCHIP Extension Act of 2007 (MMSEA) (CMS-6061-ANPRM) 0938-AR88
HHS/CMS Prerule Stage Methodology for Adjusting Medicare Fee Schedule Amounts for DMEPOS Using Information From Competitive Bidding Programs (CMS-1460-ANPRM) 0938-AS05
HHS/CMS Proposed Rule Stage Emergency Preparedness Requirements for Medicare and Medicaid Participating Providers and Suppliers (CMS-3178-P) 0938-AO91
HHS/CMS Proposed Rule Stage Administrative Simplification: Compliance: Health Plan Certification (CMS-0037-P) 0938-AQ85
HHS/CMS Proposed Rule Stage Policy and Technical Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit Programs for Contract Year 2015 (CMS-4159-P) 0938-AR37
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 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-F) 0938-AR62
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 CY 2015 Notice of Benefit and Payment Parameters (CMS-9954-P) 0938-AR89
HHS/CMS Proposed Rule Stage Establishment of the Basic Health Program (CMS-2380-F) 0938-AR93
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 Establishment of Quality Standards for Exchanges and Qualified Health Plans (QHPs) (CMS-3288-P) 0938-AS00
HHS/CMS Proposed Rule Stage Eligibility, Enrollment, and Appeals Updates (CMS-9949-P) 0938-AS02
HHS/CMS Proposed Rule Stage Medicare Secondary Payer-Applicable Plans and Appeals (CMS-6055-P) 0938-AS03
HHS/CMS Proposed Rule Stage Clinical Laboratory Improvement Amendment (CLIA)--Clarification of Waived Test Descriptor (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 Final Rule Stage Home and Community-Based State Plan Services Program, Waivers, and Provider Payment Reassignments (CMS-2249-F) 0938-AO53
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 CLIA Programs and HIPAA Privacy Rule; Patients' Access to Test Reports (CMS-2319-F) 0938-AQ38
HHS/CMS Final Rule Stage Covered Outpatient Drugs (CMS-2345-F) 0938-AQ41
HHS/CMS Final Rule Stage Home Health Prospective Payment System Rate for CY 2014 (CMS-1450-F) 0938-AR52
HHS/CMS Final Rule Stage CY 2014 Changes to the End-Stage Renal Disease (ESRD) Prospective Payment System, ESRD Quality Incentive Program, and Durable Medical Equipment (CMS-1526-F) 0938-AR55
HHS/CMS Final Rule Stage Revisions to Payment Policies Under the Physician Fee Schedule and Medicare Part B for CY 2014 (CMS-1600-F) 0938-AR56
HHS/CMS Final Rule Stage Physicians' Referrals to Health Care Entities With Which They Have Financial Relationships; Amending the Exception for Certain Electronic Health Records Arrangements (CMS-1454-F) 0938-AR70
HHS/CMS Final Rule Stage Ninety-Day Waiting Period Limitation and Technical Amendments to Certain Health Coverage Requirements Under the Affordable Care Act (CMS-9952-F) 0938-AR77
HHS/CMS Final Rule Stage Influenza Vaccination Standard for Certain Participating Providers and Suppliers (CMS-3213-F) 0938-AR80
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 B Monthly Actuarial Rates, Monthly Premium Rates, and Annual Deductible (CMS-8058-N) 0938-AR95
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/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 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 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 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 Voluntary 2015 Edition Electronic Health Record (EHR) Certification Criteria; Interoperability Updates and Regulatory Improvements 0991-AB92
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 Health and Human Services Acquisition Regulation (HHS' Supplement to the Federal Acquisition Regulation) 0991-AB88
HHS/OS Final Rule Stage Official HHS Symbol, Logo, and Seal 0991-AB89
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