January 2011 HHS Semiannual Regulatory Agenda

Regulations.
gov
Friday, January 20, 2012
Unified Agenda
DEPARTMENT OF HEALTH AND HUMAN SERVICES Office of the Secretary 21 CFR Ch. I 42 CFR Chs. I-V 45 CFR Subtitle A; Subtitle B, Chs. II, III, and XIII Regulatory Agenda AGENCY: Office of the Secretary, HHS ACTION: Semiannual Regulatory Agenda
SUMMARY: The Regulatory Flexibility Act of 1980 and Executive Order (EO) 12866 require the semiannual issuance of an inventory of rulemaking actions under development throughout the Department with a view to offering summarized information about forthcoming regulatory actions for public review.
FOR FURTHER INFORMATION CONTACT: Jennifer M. Cannistra, Executive Secretary, Department of Health and Human Services, Washington, D.C. 20201.
SUPPLEMENTARY INFORMATION: The information provided in the Agenda presents a forecast of the rulemaking activities that the Department of Health and Human Services (HHS) expects to undertake in the foreseeable future. Rulemakings are grouped according to pre-rulemaking actions, proposed rules, final rules, long-term actions, and rulemaking actions completed since the spring 2011 Agenda was published. Please note that the rulemaking abstracts included in this paper issue of the Federal Register relate strictly to those prospective rulemakings that are likely to have a significant economic impact on a substantial number of small entities, as required by the Regulatory Flexibility Act of 1980. Also available in this issue of the Register is the Departments submission to the Fiscal Year 2011 Regulatory Plan, required under Executive Order 12866.
Regulations.gov
Unified Agenda
The complete Regulatory Agenda of the Department is accessible online at www.reginfo.gov in an interactive format that offers users enhanced capabilities to obtain information from the Agendas database. The purpose of the Agenda is to encourage more effective public participation in the regulatory process.
NAME: Jennifer M. Cannistra, Executive Secretary to the Department
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The 251 Regulatory Agendas
Health Resources and Services Administration - Proposed Rule

Title Add Vascularized Composite Allografts to the Definition of Organs Covered by the Rule Governing the Operation of the Organ Procurement and Transplantation Network (OPTN) Countermeasures Injury Compensation Program; Pandemic Influenza Countermeasure Injury Table Amendment for Influenza Vaccines, Antiviral Drugs, Respiratory Protection/Support Devices, and Diagnostics Countermeasures Injury Compensation Program; Smallpox Injury Table Amendment Countermeasures Injury Compensation Program; Anthrax Injury Table Amendment Elimination of Duplication Between the Healthcare Integrity and Protection Data Bank and the National Practitioner Data Bank Amendments to the Rule Governing the Operation of the Organ Procurement and Transplantation Network (OPTN) Regulation Identifier Number
0906-AA73 0906-AA79 0906-AA84 0906-AA85 0906-AA87 0906-AA95
Health Resources and Services Administration - Final Rule

Title Health Center Federal Tort Claims Act (FTCA) Medical Malpractice Program Regulations--Clarification of FTCA Coverage for Services Provided to Non-Health Center Patients 340B Orphan Drug Exclusion Regulation Identifier Number
0906-AA77 0906-AA94
Health Resources and Services Administration - Long-term Action

Title Designation of Medically Underserved Populations and Health Professional Shortage Areas 340B Drug Pricing Program; Manufacturer Civil Monetary Penalties 340B Drug Pricing Program; Administrative Dispute Resolution Process 340B Ceiling Price Regulations 340B Civil Monetary Penalties for Covered Entities Regulation Identifier Number
0906-AA44 0906-AA89 0906-AA90 0906-AA92 0906-AA93
Health Resources and Services Administration - Completed Action

Title National Vaccine Injury Compensation Program; Separate Category for Hepatitis A, Influenza, Meningococcal, Human Papillomavirus Vaccines Countermeasures Injury Compensation Program; Administrative Implementation Privacy Act; Exempt Record System Regulation Identifier Number
0906-AA74 0906-AA83 0906-AA91
Food and Drug Administration - PreRule

Title Over-the-Counter (OTC) Drug Review--Sunscreen Products Prescription Drug Marketing Act of 1987; Prescription Drug Amendments of 1992; Policies, Requirements, and Administrative Procedures Non-Face -to-Face Sale and Distribution of Tobacco Products and Advertising, Promotion, and Marketing of Tobacco Products Reports of Distribution and Sales Information for Antimicrobial Active Ingredients Used in Food-Producing Animals Regulation Identifier Number
0910-AF43 0910-AG14 0910-AG43
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Unified Agenda
0910-AG45
Requirements for Testing Human Blood Donors for Evidence of Infection Due to Communicable Disease Agents General Requirements for Blood, Blood Components, and Blood Derivatives; Donor Notification
0910-AG61 0910-AG62
Food and Drug Administration - Proposed Rule

Title Electronic Submission of Data From Studies Evaluating Human Drugs and Biologics Over-the-Counter (OTC) Drug Review--Internal Analgesic Products Over-the-Counter (OTC) Drug Review--Topical Antimicrobial Drug Products Import Tolerances for Residues of Unapproved New Animal Drugs in Food Laser Products; Amendment to Performance Standard Proposed Revisions To Implement Portions of Title XI of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 and Other Changes Current Good Manufacturing Practice and Hazard Analysis and Risk-Benefit Preventive Controls for Food for Animals Over-the-Counter (OTC) Drug Review-Pediatric Dosing for Cough/Cold Products New Animal Drugs: Updating Tolerances for Residues in New Animal Drugs in Food Electronic Distribution of Content of Labeling for Human Prescription Drug and Biological Products Amendment to the Current Good Manufacturing Practice Regulations for Finished Pharmaceuticals--Second Phase 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 Unique Device Identification Produce Safety Regulation Hazard Analysis and Risk-Based Preventive Controls Additions to the List of Tropical Diseases in Section 524 of the Federal Food, Drug, and Cosmetic Act "Tobacco Products" Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act Amendment to Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco To Protect Children and Adolescents Human Subject Protection; Acceptance of Data From Clinical Studies for Medical Devices General Hospital and Personal Use Devices: Issuance of Draft Special Controls Guidance for Infusion Pumps Requirements for the Testing and Reporting of Tobacco Product Constituents, Ingredients, and Additives Foreign Supplier Verification Program Accreditation of Third Parties to Conduct Food Safety Audits and for Other Related Purposes Amendments to the Current Good Manufacturing Practice Regulations for Finished Pharmaceuticals--Components Orphan Drug Regulations Use of Symbols in Labeling Effective Date of Requirement for Premarket Approval for Two Class III Preamendments Devices Requirements for the Submission of Data Needed to Calculate User Fees for Manufacturers and Importers of Tobacco Products Regulation Identifier Number
0910-AC52 0910-AF36 0910-AF69 0910-AF78 0910-AF87 0910-AF97 0910-AG10 0910-AG12 0910-AG17 0910-AG18 0910-AG20 0910-AG26 0910-AG31 0910-AG35 0910-AG36 0910-AG37 0910-AG38 0910-AG40 0910-AG48 0910-AG54 0910-AG59 0910-AG64 0910-AG66 0910-AG70 0910-AG72 0910-AG74 0910-AG78 0910-AG81
Food and Drug Administration - Final Rule

Title 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 Blood Initiative --Revisions to Labeling Requirements for Blood and Blood Components, Including Source Plasma Infant Formula: Current Good Manufacturing Practices; Quality Control Procedures; Notification Requirements; Records and Reports; and Quality Factors Label Requirement for Food That Has Been Refused Admission Into the United States Current Good Manufacturing Practice for Combination Products Postmarket Safety Reporting for Combination Products Regulation Identifier Number
0910-AA49 0910-AF26 0910-AF27 0910-AF61 0910-AF81 0910-AF82
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0910-AF86 0910-AF88 0910-AF90 0910-AF96 0910-AG16 0910-AG49 0910-AG56 0910-AG57 0910-AG65 0910-AG67 0910-AG71 0910-AG84
Medical Device Reporting; Electronic Submission Requirements Electronic Registration and Listing for Devices Exceptions or Alternatives To Labeling Requirements for Products Held by the Strategic National Stockpile Postmarketing Safety Reports for Human Drug and Biological Products: Electronic Submission Requirements Amendments to Sterility Testing Requirements for Biological Products Disqualification of a Clinical Investigator Food Labeling: Nutrition Labeling for Food Sold in Vending Machines Food Labeling: Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments Prior Notice of Imported Food Administrative Detention of Food for Human or Animal Consumption Additional Safeguards for Children in Clinical Investigation of FDA-Regulated Products Food Labeling; Gluten-Free Labeling of Foods
Food and Drug Administration - Long-term Action

Title Food Labeling; Revision of the Nutrition and Supplement Facts Labels Over-the-Counter (OTC) Drug Review--Oral Health Care Products Use of Materials Derived From Cattle in Human Food and Cosmetics Pet Food Labeling Requirements Animal Drugs, Feeds, and Related Products; Regulation of Carcinogenic Compounds in Food-Producing Animals Food Labeling; Dietary Guidance Statements Further Amendments to General Regulations of the Food and Drug Administration to Incorporate Tobacco Products Food Labeling: Hard Candies and Breath Mints Food Labeling; Serving Sizes; Reference Amounts for Candies Tobacco Product Standard Blood Initiative --Requirements for Human Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use Regulation Identifier Number
0910-AF22 0910-AF40 0910-AF47 0910-AG09 0910-AG28 0910-AG50 0910-AG60 0910-AG82 0910-AG83 0910-AG86 0910-AG87
Food and Drug Administration - Completed Action

Title Medical Devices; Exception From General Requirements for Informed Consent Over-the-Counter (OTC) Drug Review--Cough/Cold (Bronchodilator) Products Over-the-Counter (OTC) Drug Review--Poison Treatment Drug Products Animal Food Labeling; Declaration of Certifiable Color Additives Tobacco Product Substantial Equivalence Exemptions Cigarette Warning Label Statements Effective Date of Requirement for Premarket Approval for Three Class III Preamendments Devices Regulation Identifier Number
0910-AC25 0910-AF32 0910-AF68 0910-AG02 0910-AG39 0910-AG41 0910-AG51
Indian Health Service - Proposed Rule

Title Standards for the Planning, Design, Construction and Operation of Health Care and Sanitation Facilities Confidentiality of Medical Quality Assurance Records; Qualified Immunity for Participants Catastrophic Health Emergency Fund (CHEF) Regulation Identifier Number
0917-AA08 0917-AA09 0917-AA10
Centers for Disease Control and Prevention - Proposed Rule

5
Regulation
Regulations.gov

Title
Unified Agenda
Identifier Number
Amendments to Specifications for Medical Examinations of Underground Coal Miners Inward Leakage Requirements for Respirators Public Health Security and Bioterrorism Preparedness and Response Act of 2002; Biennial Review and Republication of the Select Agent and Toxin List Control of Communicable Diseases: Foreign and Possessions; Proposed Revision of CDC Etiological Agents Importation Regulations Open -Circuit Self-Contained Breathing Apparatus End -of-Service -Time Indicator Performance Requirements Amendments to Respirator Certification Fees Establishment of Minimum Standards for Birth Certificates Establishment of User Fees for Filovirus Testing of Nonhuman Primate Liver Samples
0920-AA21 0920-AA33 0920-AA34 0920-AA37 0920-AA38 0920-AA42 0920-AA46 0920-AA47
Centers for Disease Control and Prevention - Final Rule

Title Approval Tests and Standards for Closed -Circuit Escape Respirators Control of Communicable Diseases: Foreign and Possessions Regulations; Nonhuman Primate Guidelines for Determining the Probability of Causation Under the Energy Employees Occupational Illness Compensation Program Act of 2000; Revision of Guidelines for Non-Radiogenic Cancers World Trade Center Health Program Requirements for Enrollment, Appeals, Certification of Health Conditions, and Reimbursement World Trade Center Health Program Requirements for the Addition of New WTC-Related Health Conditions Regulation Identifier Number
0920-AA10 0920-AA23 0920-AA39 0920-AA44 0920-AA45
Centers for Disease Control and Prevention - Long-term Action

Title Control of Communicable Diseases: Foreign Control of Communicable Diseases: Interstate Regulation Identifier Number
0920-AA12 0920-AA22
Centers for Disease Control and Prevention - Completed Action

Title Amendments To Establish Wildland Firefighting Protection Performance Requirements for Approval of Respiratory Protective Devices Regulation Identifier Number
0920-AA36
National Institutes of Health - Proposed Rule

Title National Institutes of Health Loan Repayment Programs Undergraduate Scholarship Program Regarding Professions Needed by the National Institutes of Health Expanded Registration and Results Reporting at ClinicalTrials.gov Regulation Identifier Number
0925-AA43 0925-AA48 0925-AA55
National Institutes of Health - Final Rule

Title Privacy Act Regulation Concerning NIH Records Related to Research Misconduct Proceedings Regulation Identifier Number
0925-AA58
National Institutes of Health - Completed Action

Title Regulation Identifier Number
Regulations.gov
Endowment Program NIH Training Grants
Unified Agenda
0925-AA47 0925-AA49 0925-AA53 0925-AA57
Amendment of Regulation of the Responsibility of Applicants for Promoting Objectivity in Research for Which PHS Funding Is Sought and Responsible Prospective Contractors National Institutes of Health Construction Grants
Substance Abuse and Mental Health Services Administration - Final Rule

Title Opioid Drugs in Maintenance or Detoxification Treatment of Opiate Addiction Regulation Identifier Number
0930-AA14
Substance Abuse and Mental Health Services Administration - Completed Action

Title Protection and Advocacy for Individuals With Mental Illness Community Mental Health Services and Substance Abuse Prevention and Treatment Block Grants Regulation Identifier Number
0930-AA15 0930-AA16
Office of the Inspector General - Proposed Rule

Title Medicare and State Health Care Programs: Fraud and Abuse; Revisions to the Office of Inspector General's Safe Harbors Under the Antikickback Status, Exclusion Authorities, and Civil Monetary Penalty Regulation Identifier Number
0936-AA02
Office of the Inspector General - Final Rule

Title Revision to Prohibition on FFP for "Data Mining" by Medicaid Fraud Control Units Regulation Identifier Number
0936-AA01
Office of Assistant Secretary for Health - Proposed Rule

Title Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators Regulation Identifier Number
0937-AA02
Office of Assistant Secretary for Health - Completed Action

Title Public Health Service Standards for the Protection of Research Misconduct Whistleblowers Regulation Identifier Number
0937-AA03
Centers for Medicare & Medicaid Services - Proposed Rule

Title Home and Community-Based State Plan Services Program and Provider Payment Reassignments (CMS-2249 -P2) Administrative Simplification: Standard Unique Identifier for Health Plans (CMS-0040 -P) Medicaid Disproportionate Share Hospital Payments Uninsured Definition (CMS-2315 -P) Covered Outpatient Drugs (CMS-2345 -P) Reporting and Returning of Overpayments (CMS-6037 -P) Payments for Primary Care Services Under the Medicaid Program (CMS-2370 -P) Medicare and Medicaid Electronic Health Record Incentive Program--Stage 2 (CMS-0044 -P) Administrative Simplification: Compliance: Health Plan Certification (CMS-0037 -P) Regulation Identifier Number
0938-AO53 0938-AQ13 0938-AQ37 0938-AQ41 0938-AQ58 0938-AQ63 0938-AQ84 0938-AQ85
Regulations.gov
Unified Agenda
Policy and Technical Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit Programs for Contract Year 2013 (CMS-4157 -F) Medicare and Medicaid Programs: Reform of Hospital and Critical Access Hospital Conditions of Participation (CMS3244 -P) Long Term Care: Ethics and Compliance (CMS-3226 -P) Regulatory Provisions To Promote Program Efficiency, Transparency, and Burden Reduction (CMS-9070 -P) Establishment of Exchange Program Part II; Appeals of Eligibility Determinations and Oversight and Financial Integrity (CMS-9980 -P) Medicaid Eligibility Changes Under the Affordable Care ActPart II (CMS-2334 -P) Proposed Changes to Hospital OPPS and CY 2013 Payment Rates; ASC Payment System and CY 2013 Payment Rates (CMS-1589 -P) Revisions to Payment Policies Under the Physician Fee Schedule and Part B for CY 2013 (CMS-1590 -P) Changes to the Hospital Inpatient an Long -Term Care Prospective Payment System for FY 2013 (CMS-1588 -P) Changes to the End -Stage Renal Disease Prospective Payment System for CY 2013 (CMS-1352 -P) Hospice Wage Index for FY 2013 (CMS-1434 -P) Home Health Prospective Payment System Rate for CY 2013 (CMS-1358 -P) Prospective Payment System and Consolidated Billing for Skilled Nursing FacilitiesUpdate for FY 2013 (CMS-1432 -P) Prospective Payment System for Inpatient Rehabilitation Facilities for FY 2013 (CMS-1433 -P) Inpatient Psychiatric Facility Prospective Payment System --Update for Fiscal Year 2013 (CMS-1440 -P) Disproportionate Share Hospital Payment Reduction (CMS-2367 -P) Transparency Reports and Reporting of Physician Ownership of Investment Interests (CMS-5060 -F)
0938-AQ86 0938-AQ89 0938-AQ93 0938-AQ96 0938-AR03 0938-AR04 0938-AR10 0938-AR11 0938-AR12 0938-AR13 0938-AR17 0938-AR18 0938-AR20 0938-AR21 0938-AR22 0938-AR31 0938-AR33
Centers for Medicare & Medicaid Services - Final Rule

Title Medicare Advantage and Prescription Drug Benefit Programs; Payments to Sponsors of Retiree Prescription Drug Plans (CMS-4131 -F2) Administrative Simplification: Adoption of Standards for Electronic Funds Transfer (EFT) (CMS-0024 -IFC) Medicaid and Children's Health Insurance Programs; Disallowance of Claims for FFP and Technical Corrections (CMS2292 -F) Community First Choice Option (CMS-2337 -F) Face -to-Face Requirements for Home Health Services; Policy Changes and Clarifications Related to Home Health (CMS-2348 -F) Review and Approval Process for Section 1115 Demonstrations (CMS-2325 -F) Emergency Medical Treatment and Labor Act: Applicability to Hospital Inpatients and Hospitals with Specialized Capabilities (CMS-1350 -N) Methods for Assuring Access to Covered Medicaid Services (CMS-2328 -F) Medicaid Eligibility Expansion Under the Affordable Care Act of 2010 (CMS-2349 -F) Establishment of Exchanges and Qualified Health Plans Part I (CMS-9989 -F) Uniform Disclosure to Consumers: Benefit Design, Cost Sharing, & Standards for Definitions (CMS-9982 -F) Affordable Care Act Waiver for State Innovation; Review and Approval Process (CMS-9987 -F) Student Health Insurance Coverage (CMS-9981 -F) Administrative Simplification: Adoption of Operating Rules for Electronic Funds Transfer (EFT) and Remittance Advice (RA) (CMS-0028 -IFC) State Requirements for Exchange --Reinsurance and Risk Adjustments (CMS-9975 -F) Inpatient Hospital Deductible and Hospital and Extended Care Services Coinsurance Amounts for CY 2013 (CMS-8046 N) Part A Premiums for CY 2013 for the Uninsured Aged and for Certain Disabled Individuals Who Have Exhausted Other Entitlement (CMS-8047 -N) Part B Monthly Actuarial Rates, Monthly Premium Rates, and Annual Deductible Beginning January 1, 2013 (CMS8048 -N) Medicare Shared Savings Program; Final Waivers (CMS-1439 -IFC) Regulation Identifier Number
0938-AP64 0938-AQ11 0938-AQ32 0938-AQ35 0938-AQ36 0938-AQ46 0938-AQ51 0938-AQ54 0938-AQ62 0938-AQ67 0938-AQ73 0938-AQ75 0938-AQ95 0938-AR01 0938-AR07 0938-AR14 0938-AR15 0938-AR16 0938-AR30
Centers for Medicare & Medicaid Services - Long-term Action

Regulation
Regulations.gov

Title
Unified Agenda
Identifier Number
Requirements for Long -Term Care Facilities: Hospice Services (CMS-3140 -F) Conditions of Participation (CoPs) for Community Mental Health Centers (CMHCs)(CMS-3202 -F) Home and Community Based Services Waivers (CMS-2296 -F) Survey and Enforcement Requirements for Home Health Agencies (CMS-3256 -P) Changes in Provider and Supplier Enrollment, Ordering and Referring, and Documentation Requirements; and Changes in Provider Agreements (CMS-6010 -F) CLIA Programs and HIPAA Privacy Rule; Patients' Access to Laboratory Test Reports (CMS-2319 -F) Revisions to Certain Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) Suppliers Safeguards (CMS-6036 -F2) Preventive Services Under the Affordable Care Act (CMS-9992 -F) Skilled Nursing Facility Required Disclosure of Ownership (CMS-6008 -F)
0938-AP32 0938-AP51 0938-AP61 0938-AP96 0938-AQ01 0938-AQ38 0938-AQ57 0938-AQ74 0938-AR24
Centers for Medicare & Medicaid Services - Completed Action

Title Medicare Changes in Conditions of Participation Requirements and Payment Provisions for Rural Health Clinics and Federally Qualified Health Centers (CMS-1910 -F2) Use of Restraints and Seclusion in Residential Treatment Facilities Providing Inpatient Psychiatric Services to Individuals Under Age 21 (CMS-2065 -F) Medical Improvement Eligibility Group and Definition of Work (CMS-2143 -P) Optional State Plan Case Management Services (CMS-2237 -F) Standards for E -Prescribing Under Medicare Part D and the Lifting of the Long Term Care Exemption (CMS-0023 -P) Limited Changes to the Competitive Acquisition of Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS)(CMS-1561 -F) Implementing Regulations for Reauthorization of the Children's Health Insurance Program (CHIP) (CMS-2301 -P) Children's Health Insurance Program (CHIP) Child Enrollment Contingency Fund Payments (CMS-2488 -P) Ambulatory Surgical Centers Conditions for Coverage: Same-Day Services (CMS-3217 -F) Charges for Vaccine Administration Under the Vaccines for Children (VFC) Program (CMS-2310 -NC) Health Care-Related Taxes--Clarification of Definition (CMS-2314 -P) Changes Affecting Hospital and Critical Access Hospital (CAH) Conditions of Participation (CoPs): Credentialing and Privileging of Telemedicine Physicians and Practitioners (CMS-3227 -F) Long -Term Care Facility Quality Assessment and Performance Improvement Dementia Management and Abuse Prevention Training (CMS-3231 -P) Administrative Simplification: Adoption of Authoring Organizations for Operating Rules and Adoption of Operating Rules for Eligibility and Claims Status (CMS-0032 -F) Inpatient Hospital Deductible and Hospital and Extended Care Services Coinsurance Amounts for CY 2012 (CMS-8043 N) Part A Premiums for CY 2012 for the Uninsured Aged and for Certain Disabled Individuals Who Have Exhausted Other Entitlement (CMS-8044 -N) Part B Monthly Actuarial Rates, Monthly Premium Rates, and Annual Deductible Beginning January 1, 2012 (CMS8045 -N) Availability of Medicare Data for Performance Measurement (CMS-5059 -F) Medicaid Recovery Audit Contractors (CMS-6034 -F) Durable Medical Equipment (DME) Face to Face Encounters and Written Orders Prior to Delivery (CMS-6033 -P) Medicare Shared Savings Program: Accountable Care Organizations (CMS-1345 -F) Inpatient Psychiatric Facilities Prospective Payment System --Update for Rate Year and Fiscal Year Beginning July 1, 2011 (CMS-1346 -F) Proposed Changes to the Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and FY 2012 Rates and to the Long -Term Care Hospital PPS and FY 2012 Rates (CMS-1518 -F) Revisions to Payment Policies Under the Physician Fee Schedule and Part B for CY 2012 (CMS-1524 -FC) Changes to the Hospital Outpatient Prospective Payment System and Ambulatory Surgical Center Payment System for CY 2012 (CMS-1525 -F) End -Stage Renal Disease Prospective Payment System for CY 2012, Quality Incentive Program for PY 2013 and PY 2014; Ambulance Fee Schedule; and Durable Medical Equipment (CMS-1577 -F) Prospective Payment System for Inpatient Rehabilitation Facilities for FY 2012; Changes in Size of Inpatient Rehabilitation Units and Inpatient Psychiatric Units (CMS-1349 -F) Regulation Identifier Number
0938-AJ17 0938-AJ96 0938-AO10 0938-AO50 0938-AP49 0938-AP59 0938-AP68 0938-AP71 0938-AP93 0938-AP98 0938-AP99 0938-AQ05 0938-AQ10 0938-AQ12 0938-AQ14 0938-AQ15 0938-AQ16 0938-AQ17 0938-AQ19 0938-AQ21 0938-AQ22 0938-AQ23 0938-AQ24 0938-AQ25 0938-AQ26 0938-AQ27 0938-AQ28
Regulations.gov
Unified Agenda
Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities for FY 2012; Required Disclosures of Ownership (CMS-1351 -F) Home Health Prospective Payment System Refinements and Rate Update for CY 2012 (CMS-1353 -F) Hospice Wage Index for FY 2012 (CMS-1355 -F) Payment Adjustment for Provider--Preventable Conditions Including Health Care-Acquired Conditions (CMS-2400 -F) Medicaid Automated Data System Requirements and Data Elements Necessary for Program Integrity, Program Oversight, and Administration (CMS-2317 -P) HIPAA Mental Health Parity and Addiction Equity Act of 2008 Amendments (CMS-4140 -F) Enhanced Federal Funding for Medicaid Eligibility Determination and Enrollment Activities (CMS-2346 -F) Medicaid Program; Federal Medical Assistance Percentages (FMAP) for Newly Eligible Mandatory Individuals and Expansion States (CMS-2327 -P) Revisions to Medicare Advantage and Part D Prescription Drug Programs; MIPPA -Related Marketing Revisions and Agent/Broker Compensation Plan (CMS-4138 -F) Medicaid Program Integrity: Registration of Billing Agents, Clearing Houses, or Other Alternate Payees (CMS-2365 -P) Public Use Files of Health Plan Data (CMS-9984 -P) Medical Loss Ratios (CMS-9998 -FC) Elimination of the Requirement for Termination of Non-Random Prepayment Complex Medical Review (CMS-6022 -F2) Five Year Review of Work Relative Value Units Under the Physician Fee Schedule (CMS-1582 -PN) Changes to the End -Stage Renal Disease Prospective Payment System Transition Budget-Neutrality Adjustment (CMS1435 -IFC) Establishment of the Consumer Operated and Oriented Plan Program (CMS-9983 -F) Changes to the Electronic Prescribing (eRx) Incentive Program for Calendar Year 2011 (CMS-3248 -F) Clinical Laboratory Fee Schedule; Signature on Requisition (CMS-1436 -P) Exchange Functions in the Individual Market: Eligibility Determinations; Standards for Verification of Employer Sponsored Health Coverage, Employer Appeals, and Employer SHOP Participation (CMS-9974 -F Rate Increase Disclosure and Review: Definitions of "Individual Market" and "Small Group Market" (CMS-9999 -F)
0938-AQ29 0938-AQ30 0938-AQ31 0938-AQ34 0938-AQ43 0938-AQ52 0938-AQ53 0938-AQ59 0938-AQ60 0938-AQ61 0938-AQ69 0938-AQ71 0938-AQ83 0938-AQ87 0938-AQ94 0938-AQ98 0938-AR00 0938-AR06 0938-AR25 0938-AR26
Office of Public Health and Science - Completed Action

Title Public Health Service Standards for the Protection of Research Misconduct Whistleblowers Regulation Identifier Number
0940-AA01
Office for Civil Rights - Final Rule

Title HIPAA Privacy Rule Accounting of Disclosures under the Health Information Technology for Economic and Clinical Health Act Modifications to the HIPAA Privacy, Security, Enforcement, and Breach Notification Rules Regulation Identifier Number
0945-AA00 0945-AA03
Office for Civil Rights - Long-term Action

Title Nondiscrimination Under the Affordable Care Act Regulation Identifier Number
0945-AA02
Office for Civil Rights - Completed Action

Title Individual Access to Protected Health Information Held by CLIA Laboratories Regulation Identifier Number
0945-AA01
Administration for Children and Families - Proposed Rule

Title Regulation Identifier Number
10
Regulations.gov
Unified Agenda
Implementation of the Unaccompanied Alien Children (UAC) Provisions of the Trafficking Victims Reauthorization Act of 2008 Performance Standards for Runaway and Homeless Youth Grantees Flexibility and Efficiency in Child Support Federal Case Registry System of Records Exemption Child Care and Development Fund Reforms to Support Child Development and Working Families
0970-AC42 0970-AC43 0970-AC50 0970-AC52 0970-AC53
Administration for Children and Families - Final Rule

Title Tribal Child Welfare Head Start Eligibility Determinations Regulation Identifier Number
0970-AC41 0970-AC46
Administration for Children and Families - Completed Action

Title Designation Renewal of Head Start Grantees Strengthen Medical Support in the Child Support Program Improving Payment Processing in the Child Support Enforcement Program Regulation Identifier Number
0970-AC44 0970-AC48 0970-AC49
Administration on Aging - Proposed Rule

Title Older Americans Act --Ombudsman Program Regulation Identifier Number
0985-AA08
Administration on Aging - Completed Action

Title Community Living Assistance Services and Supports (CLASS) Program--Designation of the CLASS Independence Benefit Plan and Enrollment Rules Regulation Identifier Number
0985-AA07
Office of the Secretary - PreRule

Title Governance for a Nationwide Health Information Network Regulation Identifier Number
0991-AB83
Office of the Secretary - Proposed Rule

Title Health Information Technology: New and Revised Standards, Implementation Specifications, and Certification Criteria for Electronic Health Record Technology Regulation Identifier Number
0991-AB82
Office of the Secretary - Completed Action

Title Shared Risk Exception to the Safe Harbor Provisions Principles for Determining Costs at Hospitals Under Federal Grants, Contracts, and Cooperative Agreements Rescission of Interest Prohibition in the Principles for Determining Costs at Hospitals Under Federal Grants, Contracts, and Cooperative Agreements Revision to Prohibition on FFP for "Data Mining" by Medicaid Fraud Control Units Regulation Identifier Number
0991-AA91 0991-AB51 0991-AB52 0991-AB61
11
Regulations.gov
Unified Agenda
HIPAA Privacy Rule Accounting of Disclosures under the Health Information Technology for Economic and Clinical Health Act Individual Access to Protected Health Information Held by CLIA Laboratories Nondiscrimination Under the Affordable Care Act Permanent Certification Program for Health Information Technology; Revisions to ONC-AA Processes Metadata Standards to Support Nationwide Electronic Health Information Exchange Modifications to the HIPAA Privacy, Security, Enforcement, and Breach Notification Rules Medicare and State Health Care Programs: Fraud and Abuse; Revisions to the Office of Inspector General's Safe Harbors Under the Antikickback Status, Exclusion Authorities, and Civil Monetary Penalty Permanent Certification Program for Health Information Technology; Revisions to ONC-AA Processes
0991-AB62 0991-AB74 0991-AB75 0991-AB77 0991-AB78 0991-AB80 0991-AB81 0991-AB84
Department of Health and Human Services (HHS) Health Resources and Services Administration ( HRSA )
RIN: 0906-AA73 View Related Documents
Title: Add Vascularized Composite Allografts to the Definition of Organs Covered by the Rule Governing the Operation of the Organ Procurement and Transplantation Network (OPTN) Abstract: This notice of proposed rulemaking will add vascularized composite allografts (VCA) to the definition of "organs" for purpose of coverage under NOTA and the OPTN final rule. NOTA authorizes the Secretary to include by regulation, additional organs under the definition of organ. Currently, the OPTN final rule defines covered organs as "a human kidney, liver, heart, lung, pancreas, or intestine (including the esophagus, stomach, small and/or large intestine, or any portion of the gastrointestinal tract)." VCA transplantation comprises transplants of a variety of body parts (i.e. hand and face transplants) that are not currently regulated and which share common characteristics. Priority: Other Significant Agenda Stage of Rulemaking: Proposed Rule Major: No Unfunded Mandates: No CFR Citation: 42 CFR 121 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: sec 301 of the National Organ Transplant Act (NOTA) of 1984, as amended; sec 371 to 376 of the Public Health Service Act; sec 1138 of the Social Security Act Legal Deadline: None Timetable:
Action NPRM NPRM Comment Period End Date 12/16/2011 02/14/2012 FR Cite 76 FR 78216
Regulatory Flexibility Analysis Required: No Small Entities Affected: No Agency Contact: Dr. James Bowman Medical Director, Division of Transplantation Department of Health and Human Services Health Resources and Services Administration 5600 Fishers Lane Room 12C-06 Rockville , MD 20857 Phone: 301 443-4861
Government Levels Affected: No Federalism: No
Title: Countermeasures Injury Compensation Program; Pandemic Influenza Countermeasure Injury Table Amendment for Influenza Vaccines, Antiviral Drugs, Respiratory Protection/Support Devices, and Diagnostics Abstract: This proposed rule establishes the Pandemic Influenza Countermeasure Injury Table for Influenza Vaccines, Antiviral Medications, Respiratory Protection Devices, Respiratory Support Devices, and Diagnostics for the Countermeasure Injury Compensation Program (CICP). The Public Readiness and Emergency Preparedness Act (PREP Act) authorized the Secretary of HHS to establish the CICP to provide benefits to certain persons who sustain serious physical injury or death as a direct result of the administration or use of covered countermeasures identified by the Secretary in declarations issued under the 12
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PREP Act. In addition, the Secretary may provide death benefits to certain survivors of individuals who died as a direct result of covered injuries or their health complications. One way that an individual who was administered or used a covered countermeasure can show that they sustained a covered injury is by demonstrating that they sustained an injury listed on a Countermeasures Injury Table (Table) within the time interval set forth on the Table. This rule will be an amendment to the CICP Administrative Interim Final Rule and will list and explain injuries that, based on compelling, reliable, valid, medical, and scientific evidence, are presumed to be caused by covered Pandemic Influenza Vaccines, Antiviral Medications, Respiratory Protection Devices, Respiratory Support Devices, and Diagnostics, and set forth the time periods in which the onset of these injuries must occur after the administration or use of these covered Pandemic influenza countermeasures. Priority: Other Significant Agenda Stage of Rulemaking: Proposed Rule Unfunded Mandates: No Major: Undetermined CFR Citation: 42 CFR 110 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: PL109-148; sec 31F-3 and 319F-4 of the PHS Act Legal Deadline: None Timetable:
Action NPRM Date 06/00/2012 FR Cite
Regulatory Flexibility Analysis Required: No Government Levels Affected: No Federalism: No Energy Affected: No Agency Contact: Dr. Vito Caserta Director, Countermeasures Injury Compensation Program Department of Health and Human Services Health Resources and Services Administration Healthcare Systems Bureau Room 11C-26 5600 Fishers Lane Rockville , MD 20857 Phone: 301 443-5287 E-Mail: cicp@hrsa.gov
Title: Countermeasures Injury Compensation Program; Smallpox Injury Table Amendment Abstract: This rule will establish the Smallpox Injury Table for the Countermeasures Injury Compensation Program (CICP). The Public Readiness and Emergency Preparedness Act (PREP Act) authorized the Secretary of HHS to establish the CICP to provide benefits to certain persons who sustain serious physical injury or death as a direct result of the administration or use of covered countermeasures identified by the Secretary in declarations issued under the PREP Act. In addition, the Secretary may provide death benefits to certain survivors of individuals who died as a direct result of such covered injuries or their health complications. One way that an individual who was administered or used a covered countermeasure can show that they sustain a covered injury is by demonstrating that they sustained an injury listed on a Countermeasures Injury Table (Table) within the time interval set forth on the Table. This rule will be an amendment to the CICP Administrative Interim Final Rule and will list and explain injuries that, based on compelling, reliable, valid, medical and scientific evidence, are presumed to be caused by covered smallpox countermeasures, and the time periods in which the onset of these injuries must occur after the administration or use of these covered smallpox countermeasures. Priority: Other Significant Agenda Stage of Rulemaking: Proposed Rule Major: No Unfunded Mandates: No CFR Citation: 42 CFR 110 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: PL 109-148, sec 31F-3 and 319F-4 of PHS Act as amended; 42 USC 247d-6d and 247d-6e Legal Deadline: None Timetable:
Regulatory Flexibility Analysis Required: No
Government Levels Affected: No 13
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Federalism: No Energy Affected: No Agency Contact: Dr. Vito Caserta Director, Countermeasures Injury Compensation Program Department of Health and Human Services Health Resources and Services Administration Healthcare Systems Bureau 5600 Fishers Lane Room 11C-26 Rockville , MD 20857 Phone: 301 443-5287 E-Mail: cicp@hrsa.gov
Title: Countermeasures Injury Compensation Program; Anthrax Injury Table Amendment Abstract: This rule will establish the Anthrax Injury Table for the Countermeasures Injury Compensation Program (CICP). The Public Readiness and Emergency Preparedness Act (PREP Act) authorized the Secretary of HHS to establish the CICP to provide benefits to certain persons who sustain serious physical injury or death as a direct result of the administration or use of covered countermeasures identified by the Secretary in declarations issued under the PREP Act. In addition, the Secretary may provide death benefits to certain survivors of individuals who died as a direct result of such covered injuries or their health complications. One way that an individual who was administered or used a covered countermeasure can show that they sustain a covered injury is by demonstrating that they sustained an injury listed on a Countermeasures Injury Table (Table) within the time interval set forth on the Table. This rule will be an amendment to the CICP Administrative Interim Final Rule and will list and explain injuries that, based on compelling, reliable, valid, medical and scientific evidence, are presumed to be caused by covered anthrax countermeasures, and the time periods in which the onset of these injuries must occur after the administration or use of these covered anthrax countermeasures. Priority: Other Significant Agenda Stage of Rulemaking: Proposed Rule Unfunded Mandates: No Major: No CFR Citation: 42 CFR 110 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: PL 109-148 sec 31F-3 and319F-4 PHA; 42 USC 247d-6e Legal Deadline: None Timetable:
Regulatory Flexibility Analysis Required: No Government Levels Affected: No Federalism: Undetermined Energy Affected: No Agency Contact: Dr. Vito Caserta Director, Countermeasures Injury Compensation Program Department of Health and Human Services Health Resources and Services Administration Healthcare Systems Bureau 5600 Fishers Lane Room 11C-26 Rockville , MD 20857 Phone: 301 443-5287 E-Mail: cicp@hrsa.gov
Title: Elimination of Duplication Between the Healthcare Integrity and Protection Data Bank and the National Practitioner Data Bank Abstract: This rule is required under the Affordable Care Act. The purpose is to eliminate the redundant reporting requirements 14
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for two closely related national health care data banks. This rule terminates the Healthcare Integrity and Protection Databank (HIPDB) and transfers all data collected in the HIPDB to the National Practitioner Data Bank (NPDB) established pursuant to the Health Care Quality Improvement Act of 1986. This rule will also provide for the disclosure of information, fee collection, establishment of dispute procedures, and an effective date of no later than one year after enactment or when regulations are published. Priority: Other Significant Agenda Stage of Rulemaking: Proposed Rule Unfunded Mandates: No Major: Undetermined CFR Citation: 45 CFR 60; 45 CFR 61 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: sec 6403 PPAC Act; PL 111-148; 42 USC 1320a-7e; 42 USC 11101 Legal Deadline:
Action NPRM Source Statutory PL 111 -148, sec 6403 Description Date
Timetable:
Regulatory Flexibility Analysis Required: Undetermined Federalism: No Agency Contact: Cynthia Grubbs Director of the Division of Practitioner Data Banks Department of Health and Human Services Health Resources and Services Administration 5600 Fishers lane Rockville , MD 20857 Phone: 301 443-1821 E-Mail: cynthia.grubbs@hhs.gov
Government Levels Affected: No
Title: Amendments to the Rule Governing the Operation of the Organ Procurement and Transplantation Network (OPTN) Abstract: This rule proposes changes to the existing regulations governing the operation of the Organ Procurement and Transplantation Network (OPTN) (42 CFR part 121), which propose amendments on a variety of topics, including protections for living organ donors, organ allocation, designated transplant program requirements, OPTN policymaking, and data requirements. Priority: Other Significant Agenda Stage of Rulemaking: Proposed Rule Major: No Unfunded Mandates: No CFR Citation: Not Yet Determined (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: sec 371 to 375, PHS Act, sec 1138, SS Act Legal Deadline: None Timetable:
Regulatory Flexibility Analysis Required: No Federalism: No Energy Affected: No Agency Contact: Emily Levine Special Assistant Department of Health and Human Services Health Resources and Services Administration 5600 Fishers Lane, Room 4A-53 Rockville , MD 20857 Phone: 301 443-3264
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Title: Health Center Federal Tort Claims Act (FTCA) Medical Malpractice Program Regulations--Clarification of FTCA Coverage for Services Provided to Non-Health Center Patients Abstract: This notice of proposed rulemaking proposes to amend regulations at 42 CFR part 6 (FTCA Coverage of Certain Grantees and Individuals) to include additional examples of FTCA covered activities. Recently, questions have arisen regarding the scope of FTCA regulations as they affect medical malpractice coverage for FTCA deemed health centers and non-health center patients. Section 6.6(e) of the Health Center FTCA Program regulations provides examples of situations within the scope of section 6.6(d), which authorizes FTCA medical malpractice coverage for non-health center patients. These examples include certain community-wide interventions and hospital-related activities where the health center's health care practitioners will be covered for services provided to non-health center patients. Priority: Other Significant Agenda Stage of Rulemaking: Final Rule Unfunded Mandates: No Major: No CFR Citation: 42 CFR 6 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: 42 USC 233 Legal Deadline: None Timetable:
Action NPRM NPRM Comment Period End Final Action Date 02/28/2011 04/29/2011 05/00/2012 FR Cite 76 FR 10825
Regulatory Flexibility Analysis Required: No Government Levels Affected: No Small Entities Affected: No Federalism: No Energy Affected: No Agency Contact: Suma Nair Director, Office of Quality and Data, Bureau of Primary Health Care Department of Health and Human Services Health Resources and Services Administration Room 15C-26 5600 Fishers Lane Rockville , MD 20857 Phone: 301 594-0818 E-Mail: suma.nair@hrsa.hhs.gov
Title: 340B Orphan Drug Exclusion Abstract: Under the changes made by section 2302 Health Care and Education Reconciliation Act (Pub. L. 111-152), orphan drugs, when used for the rare condition or disease for which that orphan drug was designated under section 526 of the Federal Food, Drug, and Cosmetic Act (FFDCA), are excluded from the definition of covered outpatient drug for the specified newlyeligible covered entity types for purposes of the 340B Program. This regulatory action details how these exclusions will be implemented under the 340B Program. The purpose of issuing this proposed rule is to clarify HHS's stated effort in: (1) Providing clarity in the marketplace, (2) maintaining the 340B savings and interests to the newly-eligible covered entities; and (3) protecting the financial incentives for manufacturing orphan drugs designated for a rare disease or condition as indicated in the Affordable Care Act as intended by Congress. Priority: Other Significant Agenda Stage of Rulemaking: Final Rule Unfunded Mandates: No Major: No CFR Citation: 42 CFR 10 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: 340B PHS Act (42 USC 256b), as amended; sec 215 PHS Act (42 USC 216), as amended; sec 526 FFDC
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Act (21 USC 360bb); sec 701(a) FFDC Act (21 USC 371(a) Legal Deadline: None Timetable:
Regulatory Flexibility Analysis Required: No Federalism: No Energy Affected: No Agency Contact: Bradford Lang Public Health Analyst/Health Care System Bureau Department of Health and Human Services Health Resources and Services Administration 5600 Fishers Lane, Room 10c-03 Rockville , MD 20857 Phone: 301 443-2671
Title: Designation of Medically Underserved Populations and Health Professional Shortage Areas Abstract: This rulemaking is mandated under the Affordable Care Act. It requires the Secretary to establish a committee to draft an interim final rule for designation of Medically Underserved Populations (MUPs) and Primary Care Health Professions Shortage Areas (HPSAs). A notice of intent to form the negotiated rulemaking committee was published on May 21, 2010 (75 FR 26167), and the Secretary announced committee membership on July 21, 2010. The rulemaking committee consists of technical experts representing stakeholders that will be significantly affected by this rule. A variety of federal and state programs target resources to underserved populations using MUP and HPSA designations. These designations have not been updated in many cases for over 20 years and may not reflect current conditions in many areas. The task of the rulemaking committee is to update the designations, which will likely involve revisions to the current methodologies to reflect changes in the prevailing values of the indicators and availability of data on other indicators of underservice. Prior to passage of the Affordable Care Act, the Department made several attempts to revise the designations. An initial NPRM was published on September 1, 1998, but due to the extensive comments received, another notice was published on June 3, 1999 announcing a decision to develop and publish a revised NPRM for public comment. The second NPRM was published on February 29, 2008, with the comment period extended twice (first on April 21, 2008, and again on June 2, 2008). Substantial comments were received. A Federal Register Notice published on July 23, 2008, announcing an Agency decision to carefully review these comments, develop a modified proposal, and publish another NPRM at a future date. Priority: Other Significant Agenda Stage of Rulemaking: Long-term Action Unfunded Mandates: No Major: No CFR Citation: 42 CFR 5; 42 CFR 51c (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: 42 USC 254b; 42 USC 254e Legal Deadline: None Timetable:
Action NPRM NPRM Comment Period End Second NPRM Second NPRM Comment Period Extended Second NPRM Initial Comment Period End Second NPRM Extended Comment Period End Second NPRM Second Comment Period Extended Second NPRM Second Extension of Comment Period End NPRM Status Interim Final Rule Date 09/01/1998 11/02/1998 02/29/2008 04/21/2008 04/29/2008 05/29/2008 06/02/2008 06/30/2008 07/23/2008 12/00/2012 73 FR 42743 73 FR 31418 73 FR 11232 73 FR 21300 FR Cite 63 FR 46538
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Regulatory Flexibility Analysis Required: No Government Levels Affected: No Federalism: No Agency Contact: Andy Jordan Senior Analyst, Office of Shortage Designation, Bureau of Health Professions Department of Health and Human Services Health Resources and Services Administration Room 8A-09 Parklawn Building 5600 Fishers Lane Rockville , MD 20857 Phone: 301 594-0197 FAX: 301 443-4370 E-Mail: ajordan@hrsa.gov
Title: 340B Drug Pricing Program; Manufacturer Civil Monetary Penalties Abstract: This rulemaking is required under the Affordable Care Act. The purpose is to implement an enhancement to the 340B Program. It amends section 340B of the Public Health Service Act to impose monetary sanctions (not to exceed $5,000 per instance) on drug manufacturers who intentionally charge a covered entity (aka "safety net provider") a price above the ceiling price established under the procedures of the 340B Program. Agenda Stage of Rulemaking: Long-term Action Priority: Other Significant Major: No Unfunded Mandates: No CFR Citation: Not Yet Determined (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: sec 7102 of the Affordable Care Act; PL 111-148 amending subsec.(d); sec 340B PHS Act Legal Deadline:
Action Other Source Statutory ANPRM met deadline Description Date 09/20/2010
Timetable:
Action NPRM ANPRM ANPRM Comment Period End Date 00/00/0000 09/20/2010 11/19/2010 75 FR 57230 FR Cite
Regulatory Flexibility Analysis Required: Undetermined Federalism: No Energy Affected: No Agency Contact: Bradford Lang Public Health Analyst/Health Care System Bureau Department of Health and Human Services Health Resources and Services Administration 5600 Fishers Lane, Room 10c-03 Rockville , MD 20857 Phone: 301 443-2671
Title: 340B Drug Pricing Program; Administrative Dispute Resolution Process Abstract: This rulemaking is required under the Affordable Care Act. The purpose is to implement an enhancement to the 340B Program. This rulemaking establishes an involuntary and binding administrative dispute resolution process to resolve claims raised by covered entities (aka "safety net providers") that they have been overcharged for drugs purchased under the 340B Program. This administrative dispute resolution process also is available to drug manufacturers.
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Priority: Other Significant Agenda Stage of Rulemaking: Long-term Action Unfunded Mandates: No Major: No CFR Citation: Not Yet Determined (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: sec 7102 of the Affordable Care Act, PL 111-148, amending subsection (d) of sec 340B of the Public Health Service Act Legal Deadline:
Action Other Source Statutory Advance Notice Description Date 09/20/2010
Timetable:
Regulatory Flexibility Analysis Required: Undetermined Federalism: No Energy Affected: No Agency Contact: Bradford Lang Public Health Analyst/Health Care System Bureau Department of Health and Human Services Health Resources and Services Administration 5600 Fishers Lane, Room 10c-03 Rockville , MD 20857 Phone: 301 443-2671
Title: 340B Ceiling Price Regulations Abstract: The purpose of this rulemaking is to implement a new statutory requirement in the Affordable Care Act to develop and publish through an appropriate policy or regulation issuance, precisely defined standards and methodology for the calculation of ceiling prices for purposes of 340B. Priority: Info./Admin./Other Agenda Stage of Rulemaking: Long-term Action Major: Undetermined Unfunded Mandates: No CFR Citation: Not Yet Determined (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: sec 340B PHS Act (42 USC 256b), as amended Legal Deadline: None Timetable:
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Title: 340B Civil Monetary Penalties for Covered Entities Abstract: The purpose of this rulemaking is to implement an enhancement to the 340B Program. It amends section 340B of the Public Health Service Act to impose sanctions, in appropriate cases as determined by the Secretary, additional to those to which covered entities are subject under subsection (a)(5)(D), through one or more of the following actions: (i) Where a covered entity knowingly and intentionally violates subsection (a)(5)(B), the covered entity shall be required to pay a monetary penalty to a manufacturer or manufacturers in the form of interest on sums for which the covered entity is found liable under subsection (a)(5)(D), (ii) where the Secretary determines a violation of subsection (a)(5)(B) was systematic and egregious as well as knowing and intentional, removing the covered entity from the drug discount program under this section and disqualifying the entity from re-entry into such program for a reasonable period of time to be determined by the Secretary; and (iii) referring matters to appropriate Federal authorities within the Food and Drug Administration, the Office of Inspector General of Department of Health and Human Services, or other Federal agencies for consideration of appropriate action under other Federal statutes, such as the Prescription Drug Marketing Act (21 U.S.C. 353). Priority: Info./Admin./Other Agenda Stage of Rulemaking: Long-term Action Unfunded Mandates: No Major: No CFR Citation: Not Yet Determined (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: sec 340B PHS Act (42 USC 256b), as amended Legal Deadline: None Timetable:
Title: National Vaccine Injury Compensation Program; Separate Category for Hepatitis A, Influenza, Meningococcal, Human Papillomavirus Vaccines Abstract: This notice of proposed rulemaking proposes to change the Vaccine Injury Table (Table) to create separate categories for hepatitis A, trivalent influenza, meningococcal, and human papillomavirus (HPV) vaccines. When a vaccine is recommended for routine administration to children by the Centers for Disease Control and Prevention (CDC), and after an excise tax is imposed on it by Congress, a vaccine is added to the Table under the new vaccines category (Category XIII). These four vaccines have been recommended for routine administration to children by the CDC and have had an excise tax imposed on them. Notices were published informing the public that these four vaccines have been added to the Table under Category XIII. The next step is that new vaccines are added as their own separate categories, with associated injuries/conditions, including the time periods in which the first symptoms or significant aggravation of such injuries/conditions must occur, if applicable, once the Secretary goes through the rulemaking process. In the past, such injuries/conditions have been added based on extensive scientific reviews of medical literature for adverse events following vaccination. Because reviews for these vaccines are not expected until 2011 at the earliest, we are proceeding with rulemaking to add these four vaccines as their own separate categories in order to make clear the four vaccines are covered by the National Vaccine Injury Compensation Program. Once results of the scientific reviews are published, additional rulemaking may be necessary, if certain
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conditions are viewed by the Department as appropriate for inclusion on the Table, including the relevant time periods of onset. Priority: Other Significant Agenda Stage of Rulemaking: Completed Action Unfunded Mandates: No Major: No CFR Citation: 42 CFR 100.3(c)(5) (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: sec 2114(e)(2) of the Public Health Service Act, 42 USC 300ea-14(e)(2); sec 13632(a)(3) PL 103-66, 42 USC CFR 100.3(c)(5) Legal Deadline: None Timetable:
Action NPRM NPRM Comment Period End Final Action Date 09/13/2010 03/14/2011 06/22/2011 76 FR 36367 FR Cite 75 FR 176
Regulatory Flexibility Analysis Required: No Government Levels Affected: No Federalism: No Small Entities Affected: No Energy Affected: No Agency Contact: Dr. Geoffrey S. Evans Director, Division of Vaccine Injury Compensation, Healthcare Systems Bureau Department of Health and Human Services Health Resources and Services Administration Room 11C-26 5600 Fishers Lane Rockville , MD 20857 Phone: 301 443-6593 FAX: 301 443-8196 E-Mail: gevans@hrsa.gov
Title: Countermeasures Injury Compensation Program; Administrative Implementation Abstract: This rule establishes the administrative policies, procedures, and requirements for the Countermeasures Injury Compensation Program (CICP). The Public Readiness and Emergency Preparedness Act (PREP Act) authorizes the Secretary of HHS to establish the CICP to provide benefits to certain persons who sustain serious physical injury or death as a direct result of the administration or use of covered countermeasures identified by the Secretary in declarations issued under the PREP Act. In addition, the Secretary may provide death benefits to certain survivors of individuals who died as a direct result of such covered injuries or their health complications. Priority: Other Significant Agenda Stage of Rulemaking: Completed Action Unfunded Mandates: No Major: No CFR Citation: 42 CFR 110 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: Authorized by the Public Readiness and Emergency Preparedness Act PL 109-148, secs 31F-3 and 319F-4 of the Public Health Service Act, as amended; 42 USC 247d to 6d; 42 USC 247d to 6e Legal Deadline: None Timetable:
Action Interim Final Rule Effective Interim Final Rule Interim Final Rule Comment Period End Final Rule Date 10/15/2010 10/15/2010 12/14/2010 10/07/2011 76 FR 62306 75 FR 63656 FR Cite
Regulatory Flexibility Analysis Required: No Small Entities Affected: Business Energy Affected: No Agency Contact: Dr. Vito Caserta
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Director, Countermeasures Injury Compensation Program Department of Health and Human Services Health Resources and Services Administration Healthcare Systems Bureau 5600 Fishers Lane Room 11C-26 Rockville , MD 20857 Phone: 301 443-5287 E-Mail: cicp@hrsa.gov
Title: Privacy Act; Exempt Record System Abstract: The purpose of this proposed rule is to exempt the system of records for the National Practitioner Data Bank (NPDB) from certain provisions of the Privacy Act (5 U.S.C. 552a). Currently the system of records for the Healthcare Integrity and Protection Data Bank (HIPDB) has an exemption from certain provisions of the Privacy Act. In order to maintain this exemption for the HIPDB materials, which are now under the NPDB due to implementation of section 1921 of the Social Security Act (42 U.S.C. 1396r-2), it is necessary to expand the same privacy act exemptions for the HIPDB to the NPDB. Priority: Substantive, Nonsignificant Agenda Stage of Rulemaking: Completed Action Major: No Unfunded Mandates: No CFR Citation: 45 CFR 5b (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: 42 USC 1396r-2 and 5 USC 552a Legal Deadline: None Timetable:
Regulatory Flexibility Analysis Required: No Government Levels Affected: No Federalism: No Energy Affected: Undetermined Agency Contact: Elizabeth Rezai-Zedah Department of Health and Human Services Health Resources and Services Administration 5600 Fishers Lane, Room 8A-09 Rockville , MD 20857 Phone: 301 443-4107 E-Mail: erezai-zedah@hrsa.gov
Department of Health and Human Services (HHS) Food and Drug Administration ( FDA )
RIN: 0910-AF43 View Related Documents
Title: Over-the-Counter (OTC) Drug Review--Sunscreen Products Abstract: The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safe and effective and not misbranded. After a final monograph (i.e., final rule) is issued, only OTC drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. The first of the future actions will address the safety of sunscreen active ingredients. The second of the future actions will address active ingredients reviewed under time and extent applications. The last action addresses combination products containing sunscreen and insect repellent ingredients. Priority: Other Significant Agenda Stage of Rulemaking: PreRule Unfunded Mandates: No Major: No CFR Citation: 21 CFR 201; 21 CFR 310; 21 CFR 330 to 358 (To search for a specific CFR, visit the Code of Federal Regulations ) 22
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Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 360; 21 USC 371 Legal Deadline: None Timetable:
Action ANPRM (Sunscreen and Insect Repellent) ANPRM Comment Period End NPRM (UVA/UVB) NPRM Comment Period End ANPRM (Dosage Forms) NPRM (Effectiveness) Final Action (UVA/UVB) ANPRM (Dosage Forms) Comment Period End NPRM (Effectiveness) Comment Period End ANPRM (Safety) NPRM (Time and Extent Applications) Date 02/22/2007 05/23/2007 08/27/2007 12/26/2007 06/17/2011 06/17/2011 06/17/2011 09/15/2011 09/15/2011 06/00/2012 08/00/2012 76 FR 35669 76 FR 35672 76 FR 35620 72 FR 49070 FR Cite 72 FR 7941
Regulatory Flexibility Analysis Required: Business Government Levels Affected: Local; State Federalism: Yes Related RINs: Split From 0910-AA01 Agency Contact: David Eng Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research WO 22, Room 5487 10903 New Hampshire Avenue Silver Spring , MD 20993 Phone: 301 796-2773 FAX: 301 796-9899 E-Mail: david.eng@fda.hhs.gov
RIN: 0910-AG14 View Related Documents
Title: Prescription Drug Marketing Act of 1987; Prescription Drug Amendments of 1992; Policies, Requirements, and Administrative Procedures Abstract: Pursuant to section 610 of the Regulatory Flexibility Act, FDA is currently undertaking a review of regulations promulgated under the Prescription Drug Marketing Act (PDMA) including those contained in 21 CFR part 203 and 21 CFR sections 205.3 and 205.50 (as amended in 64 FR 67762 and 67763). The purpose of this review is to determine whether the regulations in 21 CFR part 203 and 21 CFR sections 205.3 and 205.50 (as amended in 64 FR 67762 and 67763) should be continued without change, or whether they should be amended or rescinded, consistent with the stated objectives of applicable statues, to minimize adverse impacts on a substantial number of small entities. FDA solicited comments on the following: (1) The continued need for the regulations in 21 CFR part 203 and 21 CFR sections 205.3 and 205.50 (as amended in 64 FR 67762 and 67763); (2) the nature of complaints or comments received from the public concerning the regulations in 21 CFR part 203 and 21 CFR sections 205.3 and 205.50 (as amended in 64 FR 67762 and 67763); (3) the complexity of the regulations in 21 CFR part 203 and 21 CFR sections 205.3 and 205.50 (as amended in 64 FR 67762 and 67763); (4) the extent to which the regulations in 21 CFR part 203 and 21 CFR sections 205.3 and 205.50 (as amended in 64 FR 67762 and 67763) overlap, duplicate, or conflict with other Federal rules, and to the extent feasible, with State and local governmental rules, and (5) the degree to which technology, economic conditions, or other factors have changed in the area affected by the regulations in 21 CFR part 203 and 21 CFR sections 205.3 and 205.50 (as amended in 64 FR 67762 and 67763). Last year, FDA extended the completion date by one year due to the RxUSA Wholesale, Inc., v. HHS case. Since then, the case has ended and FDA proposed to withdraw section 203.50(a). Therefore, FDA will complete the review by December 2011. Priority: Other Significant Agenda Stage of Rulemaking: PreRule Unfunded Mandates: No Major: Undetermined CFR Citation: 21 CFR 203; 21 CFR 205.3; 21 CFR 205.50 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: 21 USC 331; 21 USC 333; 21 USC 351; 21 USC 352; 21 USC 353; 21 USC 360; 21 USC 371; 21 USC 374; 21 USC 381 Legal Deadline:
Action Other Source Statutory Planned Section 610 Review Description Date 12/03/2009
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Timetable:
Action Begin Review of Current Regulation End Review of Current Regulation Date 11/24/2008 12/00/2011 FR Cite
Regulatory Flexibility Analysis Required: Business; Government Levels Affected: Federal; Local; State Governmental Jurisdictions; Organizations Federalism: No Energy Affected: No Agency Contact: Howard Muller Office of Regulatory Policy Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research WO 51, Room 6234 10903 New Hampshire Avenue Silver Spring , MD 20993-0002 Phone: 301 796-3601 FAX: 301 847-8440 E-Mail: pdma610(c)review@fda.hhs.gov
Title: Non-Face-to-Face Sale and Distribution of Tobacco Products and Advertising, Promotion, and Marketing of Tobacco Products Abstract: This rulemaking will address (1) advertising, promotion, and marketing of tobacco products and (2) sale and distribution of tobacco products involving Internet and mail-order transactions, and other transactions that involve a means "other than a direct, face-to-face exchange between a retailer and a consumer." Examples of these types of transactions include: (a) Mail-order-e.g., a print ad in a magazine that includes a phone number and/or web address for ordering a tobacco product; and (b) Internet-e.g., standard websites, such as an official website of cigarette brand or company/firm websites. Agenda Stage of Rulemaking: PreRule Priority: Other Significant Major: No Unfunded Mandates: No CFR Citation: Not Yet Determined (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: PL 111-31, sec 906, The Family Smoking Prevention and Tobacco Control Act; 21 USC 301 et seq, sec 387f, The Federal Food, Drug, and Cosmetic Act Legal Deadline:
Action Other Source Statutory Description Sec. 906(d)(4)(A)(i) of the Family Smoking Prevention and Tobacco Control Act Date 10/01/2011
Timetable:
Action ANPRM ANPRM Comment Period Extended ANPRM Comment Period End Date 09/09/2011 12/06/2011 01/19/2012 FR Cite 76 FR 55835 76 FR 76096
Regulatory Flexibility Analysis Required: Undetermined Government Levels Affected: Undetermined Federalism: Undetermined Energy Affected: Undetermined International Impacts: This regulatory action will be likely to have international trade and investment effects, or otherwise be of international interest. Agency Contact: Beth Buckler Regulatory Counsel Department of Health and Human Services Food and Drug Administration 9200 Corporate Boulevard Rockville , MD 20850
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Title: Reports of Distribution and Sales Information for Antimicrobial Active Ingredients Used in Food-Producing Animals Abstract: Section 105 of the Animal Drug User Fee Amendments of 2008 (ADUFA) amended section 512 of the Federal Food, Drug, and Cosmetic Act (the Act) (21 USC 360b) to require that the sponsor of each new animal drug product that contains an antimicrobial agent submit an annual report to the Food and Drug Administration on the amount of each antimicrobial active ingredient in the drug product that is sold or distributed for use in food-producing animals, including information on any distributor-labeled product. This rulemaking is intended to establish the implementing regulations for this statutory provision. In addition, FDA is exploring the establishment of other requirements to provide for the collection of more useful drug distribution data. Priority: Substantive, Nonsignificant Agenda Stage of Rulemaking: PreRule Major: No Unfunded Mandates: No CFR Citation: 21 CFR 514.80 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: 21 USC 360b(l)(3) Legal Deadline: None Timetable:
Action ANPRM Date 03/00/2012 FR Cite
Regulatory Flexibility Analysis Required: Undetermined Government Levels Affected: No Small Entities Affected: Business Federalism: No Agency Contact: Sharon Benz Department of Health and Human Services Food and Drug Administration Center for Veterinary Medicine MPN-4, Room 2648, HFV-220 7529 Standish Place Rockville , MD 20855 Phone: 240 453-6864 E-Mail: sharon.benz@fda.hhs.gov
Title: Requirements for Testing Human Blood Donors for Evidence of Infection Due to Communicable Disease Agents Abstract: FDA is undertaking a review of 21 CFR sections 610.40, 610.41, 610.42, 610.44, 640.67, 640.70, (as amended in 66 FR 31146) under section 610 of the Regulatory Flexibility Act. The purpose of this review is to determine whether the regulations in 21 CFR sections 610.40, 610.41, 610.42, 610.44, 640.67, 640.70 (as amended in 66 FR 31146) should be continued without change, or whether they should be amended or rescinded, consistent with the stated objectives of applicable statutes, to minimize adverse impacts on a substantial number of small entities. FDA will consider, and is soliciting comments on, the following: (1) The continued need for the rule; (2) the nature of complaints or comments received concerning the rule from the public; (3) the complexity of the rule; (4) the extent to which the rule overlaps, duplicates, or conflicts with other Federal rules, and, to the extent feasible, with State and local governmental rules; and (5) the length of time since the rule has been evaluated or the degree to which technology, economic conditions, or other factors have changed in the area affected by the rule. Agenda Stage of Rulemaking: PreRule Priority: Other Significant Major: No Unfunded Mandates: No CFR Citation: None (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: 21 USC 321; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 360; 21 USC 360c and 360d; 21 USC 360h and 360i; 21 USC 371 and 372; 21 USC 374; 21 USC 381; 42 USC 216; 42 USC 262 to 264; 42 USC 263; 42 USC 25
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263a; 42 USC 264 Legal Deadline: None Timetable:
Action Begin Review of Current Regulation End Review of Current Regulation
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Date 06/01/2011 12/00/2011
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Regulatory Flexibility Analysis Required: Business Government Levels Affected: No Federalism: No Agency Contact: Melissa Reisman Regulatory Counsel Department of Health and Human Services Food and Drug Administration Center for Biologics Evaluation and Research Suite 200N (HFM-17) 1401 Rockville Pike Rockville , MD 20852 Phone: 301 827-6210
Title: General Requirements for Blood, Blood Components, and Blood Derivatives; Donor Notification Abstract: FDA is undertaking a review of 21 CFR sections 606.100(b), 606.160(b) and 630.6 (as amended in 66 FR 31165) under section 610 of the Regulatory Flexibility Act. The purpose of this review is to determine whether the regulations in 21 CFR sections 606.100(b), 606.160(b) and 630.6 (as amended in 66 FR 31165) should be continued without change, or whether they should be amended or rescinded, consistent with the stated objectives of applicable statutes, to minimize adverse impacts on a substantial number of small entities. FDA will consider, and is soliciting comments on, the following: (1) The continued need for the rule; (2) the nature of complaints or comments received concerning the rule from the public; (3) the complexity of the rule; (4) the extent to which the rule overlaps, duplicates, or conflicts with other Federal rules, and, to the extent feasible, with State and local governmental rules; and (5) the length of time since the rule has been evaluated or the degree to which technology, economic conditions, or other factors have changed in the area affected by the rule. Priority: Other Significant Agenda Stage of Rulemaking: PreRule Unfunded Mandates: No Major: No CFR Citation: None (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: 21 USC 321; 21 USC 331; 21 USC 351 and 352; 21 USC 355; 21 USC 360 and 360j; 21 USC 371; 21 USC 374; 42 USC 216; 42 USC 262; 42 USC 263a; 42 USC 264; ... Legal Deadline: None Timetable:
Action Begin Review End Review Date 06/01/2011 12/00/2011 FR Cite
Regulatory Flexibility Analysis Required: No Government Levels Affected: No Federalism: No Agency Contact: Melissa Reisman Regulatory Counsel Department of Health and Human Services Food and Drug Administration Center for Biologics Evaluation and Research Suite 200N (HFM-17) 1401 Rockville Pike Rockville , MD 20852 Phone: 301 827-6210
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View Related Documents Title: Electronic Submission of Data From Studies Evaluating Human Drugs and Biologics Abstract: The Food and Drug Administration is proposing to amend the regulations governing the format in which clinical study data and bioequivalence data are required to be submitted for new drug applications (NDAs), biological license applications (BLAs), and abbreviated new drug applications (ANDAs). The proposal would revise our regulations to require that data submitted for NDAs, BLAs, and ANDAs, and their supplements and amendments, be provided in an electronic format that FDA can process, review, and archive. Priority: Economically Significant Agenda Stage of Rulemaking: Proposed Rule Unfunded Mandates: Private Sector Major: Yes CFR Citation: 21 CFR 314.50; 21 CFR 601.12; 21 CFR 314.94; 21 CFR 314.96 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: 21 USC 355; 21 USC 371; 42 USC 262 Legal Deadline: None Regulatory Plan: Statement of Need: Before a drug is approved for marketing, FDA must determine that the drug is safe and effective for its intended use. This determination is based in part on clinical study data and bioequivalence data that are submitted as part of the marketing application. Study data submitted to FDA in electronic format have generally been more efficient to process and review. FDA's proposed rule would address the submission of study data in a standardized electronic format. Electronic submission of study data would improve patient safety and enhance health care delivery by enabling FDA to process, review, and archive data more efficiently. Standardization would also enhance the ability to share study data and communicate results. Investigators and industry would benefit from the use of standards throughout the lifecycle of a study--in data collection, reporting, and analysis. The proposal would work in concert with ongoing Agency and national initiatives to support increased use of electronic technology as a means to improve patient safety and enhance health care delivery. Legal Basis: Our legal authority to amend our regulations governing the submission and format of clinical study data and bioequivalence data for human drugs and biologics derives from sections 505 and 701 of the Act (21 U.S.C. 355 and 371) and section 351 of the Public Health Service Act (42 U.S.C. 262). Alternatives: FDA considered issuing a guidance document outlining the electronic submission and the standardization of study data, but not requiring electronic submission of the data in the standardized format. This alternative was rejected because the Agency would not fully benefit from standardization until it became the industry standard, which could take up to 20 years. We also considered a number of different implementation scenarios, from shorter to longer time-periods. The 2-year timeperiod was selected because the Agency believes it would provide ample time for applicants to comply without too long a delay in the effective date. A longer time-period would delay the benefit from the increased efficiencies, such as standardization of review tools across applications, and the incremental cost savings to industry would be small. Costs and Benefits: Standardization of clinical data structure, terminology, and code sets will increase the efficiency of the Agency review process. FDA estimates that the costs resulting from the proposal would include substantial one-time costs, additional waves of one-time costs as standards mature, and possibly some annual recurring costs. One-time costs would include, among other things, the cost of converting data to standard structures, terminology, and cost sets (i.e., purchase of software to convert data); the cost of submitting electronic data (i.e., purchase of file transfer programs); and the cost of installing and validating the software and training personnel. Additional annual recurring costs may result from software purchases and licensing agreements for use of proprietary terminologies. The proposal could result in many long-term benefits associated with reduced time for preparing applications, including reduced preparation costs and faster time to market for beneficial products. In addition, the proposed rule would improve patient safety through faster, more efficient, comprehensive and accurate data review, as well as enhanced communication among sponsors and clinicians. Risks: None. Timetable:
Regulatory Flexibility Analysis Required: Business Federalism: No Energy Affected: No Agency Contact: Martha Nguyen Regulatory Counsel Department of Health and Human Services Food and Drug Administration
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Center for Drug Evaluation and Research WO 51, Room 6352 10903 New Hampshire Avenue Silver Spring , MD 20993-0002 Phone: 301 796-3471 FAX: 301 847-8440 E-Mail: martha.nguyen@fda.hhs.gov
Title: Over-the-Counter (OTC) Drug Review--Internal Analgesic Products Abstract: The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safe and effective and not misbranded. After a final monograph (i.e., final rule) is issued, only OTC drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. The first action addresses acetaminophen safety. The second action addresses products marketed for children under 2 years old and weight- and agebased dosing for children's products. Priority: Other Significant Agenda Stage of Rulemaking: Proposed Rule Major: No Unfunded Mandates: No CFR Citation: 21 CFR 201; 21 CFR 310; 21 CFR 330 to 358 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 360; 21 USC 371; 21 USC 374; 21 USC 379e Legal Deadline: None Timetable:
Action NPRM (Amendment) (Required Warnings and Other Labeling) NPRM Comment Period End Final Action (Required Warnings and Other Labeling) Final Action (Correction) Final Action (Technical Amendment) NPRM (Acetaminophen) NPRM (Amendment) (Pediatric) Date 12/26/2006 05/25/2007 04/29/2009 06/30/2009 11/25/2009 06/00/2012 12/00/2012 74 FR 19385 74 FR 31177 74 FR 61512 FR Cite 71 FR 77314
Regulatory Flexibility Analysis Required: Business Government Levels Affected: Local; State Federalism: Yes Related RINs: Split From 0910-AA01 Agency Contact: Mary Chung Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research WO 22, Room 5488 10903 New Hampshire Avenue Silver Spring , MD 20993 Phone: 301 796-0260 FAX: 301 796-9899 E-Mail: mary.chung@fda.hhs.gov
Title: Over-the-Counter (OTC) Drug Review--Topical Antimicrobial Drug Products Abstract: The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safe and effective and not misbranded. After a final monograph (i.e., final rule) is issued, only OTC drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. The first action addresses consumer products. The second action addresses testing requirements. Priority: Economically Significant Agenda Stage of Rulemaking: Proposed Rule
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Major: Yes Unfunded Mandates: No CFR Citation: 21 CFR 201; 21 CFR 310; 21 CFR 330 to 358 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 360; 21 USC 371 Legal Deadline: None Timetable:
Action Final Action (Food Handlers) Final Action (First Aid Antiseptic) Final Action (Testing) Final Action (Consumer) NPRM (Testing) NPRM (Food Handlers) NPRM (Healthcare) Comment Period End NPRM (Consumer) Date 00/00/0000 00/00/0000 00/00/0000 00/00/0000 00/00/0000 00/00/0000 06/17/1994 12/15/1995 04/00/2012 59 FR 31402 FR Cite
Regulatory Flexibility Analysis Required: Business Government Levels Affected: Local; State Federalism: Yes Agency Contact: David Eng Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research WO 22, Room 5487 10903 New Hampshire Avenue Silver Spring , MD 20993 Phone: 301 796-2773 FAX: 301 796-9899 E-Mail: david.eng@fda.hhs.gov
Title: Import Tolerances for Residues of Unapproved New Animal Drugs in Food Abstract: The Food and Drug Administration (FDA) plans to publish a proposed rule related to the implementation of the import tolerances provision of the Animal Drug Availability Act of 1996 (ADAA). The ADAA authorizes FDA to establish tolerances for unapproved new animal drugs where edible portions of animals imported into the United States may contain residues of such drugs (import tolerances). It is unlawful to import animal-derived food that bears or contains residues of a new animal drug that is not approved in the United States, unless FDA has established an import tolerance for that new animal drug and the residue of the new animal drug in the animal-derived food does not exceed that tolerance. Priority: Substantive, Nonsignificant Agenda Stage of Rulemaking: Proposed Rule Unfunded Mandates: No Major: No CFR Citation: Not Yet Determined (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: 21 USC 342; 21 USC 360b(a)(6); 21 USC 371 Legal Deadline: None Timetable:
Action NPRM NPRM Comment Period End Date 03/00/2012 06/00/2012 FR Cite
Regulatory Flexibility Analysis Required: Business Government Levels Affected: No Federalism: No Energy Affected: No International Impacts: This regulatory action will be likely to have international trade and investment effects, or otherwise be of international interest. Agency Contact: Thomas Moskal Consumer Safety Officer Department of Health and Human Services 29
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Food and Drug Administration Center for Veterinary Medicine, Room 101 (MPN-4, HFV-232), 7519 Standish Place Rockville , MD 20855 Phone: 240 276-9242 FAX: 240 276-9241 E-Mail: thomas.moskal@fda.hhs.gov
Title: Laser Products; Amendment to Performance Standard Abstract: FDA is proposing to amend the performance standard for laser products to achieve closer harmonization between the current standard and the International Electrotechnical Commission (IEC) standard for laser products and medical laser products. The proposed amendment is intended to update FDA's performance standard to reflect advancements in technology. The proposal would adopt portions of an IEC standard to achieve greater harmonization and reflect current science. In addition, the proposal would include an alternative mechanism for providing certification and identification, address novelty laser products, and clarify the military exemption for laser products. Agenda Stage of Rulemaking: Proposed Rule Priority: Other Significant Major: No Unfunded Mandates: No CFR Citation: 21 CFR 1002; 21 CFR 1010; 21 CFR 1040 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: 21 USC 360hh to 360ss; 21 USC 371; 21 USC 393 Legal Deadline: None Timetable:
Regulatory Flexibility Analysis Required: Business Government Levels Affected: Federal; State Federalism: Yes Energy Affected: Undetermined Agency Contact: Nancy Pirt Regulatory Counsel Department of Health and Human Services Food and Drug Administration Center for Devices and Radiological Health WO 66, Room 4438 10903 New Hampshire Avenue Silver Spring , MD 20993 Phone: 301 796-6248 FAX: 301 847-8145 E-Mail: nancy.pirt@fda.hhs.gov
Title: Proposed Revisions To Implement Portions of Title XI of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 and Other Changes Abstract: Title XI of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (Pub. L. 108-173) (MMA) amended provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that govern the approval of new drug applications (NDAs), described by section 505(b)(2) of the Act (505(b)(2) applications); and abbreviated new drug applications (ANDAs), described by section 505(j) of the Act. This proposed rule would implement portions of title XI of the MMA that pertain to: (1) Provision of notice to each patent owner and the NDA holder of certain patent certifications made by applicants submitting 505(b)(2) applications or ANDAs; (2) the availability of 30-month stays of approval on 505(b)(2) applications and ANDAs that are otherwise ready to be approved; (3) submission of amendments and supplements to 505(b)(2) applications and ANDAs; and (4) the types of bioavailability and bioequivalence data that can be used to support these applications. This proposed rule
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also would amend certain regulations regarding 505(b)(2) applications and ANDAs to facilitate compliance with and efficient enforcement of the Act. This proposed rule also would amend certain regulations regarding 505(b)(2) applications and ANDAs, including regulations related to certain patent certification requirements, identification of the listed drug relied upon, and suitability petitions, to facilitate compliance with and efficient enforcement of the Act. Priority: Other Significant Agenda Stage of Rulemaking: Proposed Rule Unfunded Mandates: No Major: Undetermined CFR Citation: 21 CFR 314.3; 21 CFR 314.50; 21 CFR 314.52; 21 CFR 314.53; 21 CFR 314.54; 21 CFR 314.60; 21 CFR 314.70; 21 CFR 314.90; 21 CFR 314.93; 21 CFR 314.94; 21 CFR 314.95; 21 CFR 314.96; 21 CFR 314.97; 21 CFR 314.99; 21 CFR 314.101; 21 CFR 314.105; 21 CFR 314.107; 21 CFR 314.108; 21 CFR 314.125; 21 CFR 314.127; 21 CFR 320.1; 21 CFR 320.23 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: PL 108-173, title XI; 21 USC 355; 21 USC 371 Legal Deadline: None Timetable:
Regulatory Flexibility Analysis Required: Undetermined Government Levels Affected: No Federalism: No Agency Contact: Janice L. Weiner Regulatory Counsel Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research, Office of Regulatory Policy WO 51, Room 6304 10903 New Hampshire Avenue Silver Spring , MD 20993-0002 Phone: 301 796-3601 FAX: 301 847-8440 E-Mail: janice.weiner@fda.hhs.gov
Title: Current Good Manufacturing Practice and Hazard Analysis and Risk-Benefit Preventive Controls for Food for Animals Abstract: The Food and Drug Administration (FDA) is proposing regulations for preventive controls for animal feed ingredients and mixed animal feed to provide greater assurance that marketed animal feed ingredients and mixed feeds intended for all animals, including pets, are safe. This action is being taken as part of the FDA's Animal Feed Safety System initiative. This action is also being taken to carry out the requirements of the Food and Drug Administration Amendments Act of 2007, under section 1002(a), and the Food Safety Modernization Act of 2010 (FSMA), under section 103. Priority: Economically Significant Agenda Stage of Rulemaking: Proposed Rule Major: Yes Unfunded Mandates: No CFR Citation: 21 CFR 228 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: 21 USC 342; 21 USC 350e; 21 USC 371; 21 USC 374; 42 USC 264; PL 110-85, sec 1002(a)(2); PL 111353 Legal Deadline: The legal deadline for FDA under the Food Safety and Modernization Act to promulgate regulations is July 2012.
Action Other Source Statutory Description FDA is directed to issue proposed and final regulations under FDA Amendments Act by the statutory deadline. Date 09/27/2009
Regulatory Plan: Statement of Need: Regulatory oversight of the animal food industry has traditionally been limited and focused on a few known safety issues, so there could be potential human and animal health problems that remain unaddressed. The massive pet food recall due to adulteration of pet food with melamine and cyanuric acid in 2007 is a prime example. The actions taken by two protein suppliers in China affected a large number of pet food suppliers in the United States and created a nationwide problem. By the time the cause of the problem was identified, melamine and cyanuric acid contaminated ingredients resulted in the adulteration of millions of individual servings of pet food. Congress passed FSMA which the President signed into law on
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January 4, 2011 (Pub. L. 111-353). Section 103 of FSMA amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) by adding section 418 (21 U.S.C. 350g) Hazard Analysis and Risk Based Preventive Controls. In enacting FSMA, Congress sought to improve the safety of food in the United States by taking a risk-based approach to food safety, emphasizing prevention. Section 418 of the FD&C Act requires owners, operators, or agents in charge of food facilities to develop and implement a written plan that describes and documents how their facility will implement the hazard analysis and preventive controls required by this section. Legal Basis: FDA's authority for issuing this rule is provided in FSMA (Pub. L. 111-353), which amended the FD&C Act by establishing section 418, which directed FDA to publish implementing regulations. FSMA also amended section 301 of the FD&C Act to add 301(uu) that states the operation of a facility that manufactures, processes, packs, or holds food for sale in the United States if the owner, operator, or agent in charge of such facility is not in compliance with section 418 of the FD&C Act is a prohibited act. Further authority comes from section 1002(a) of title X of the FDAAA of 2007 (21 U.S.C. 2102) requiring the Secretary to update standards for the processing of pet food. FDA is also issuing this rule under the general requirements of section 402 of the FD&C Act (21 U.S.C. 342) for adulterated food. In addition, section 701(a) of the FD&C Act (21 U.S.C. 371(a)) authorizes the Agency to issue regulations for the efficient enforcement of the Act. Alternatives: The 2011 FSMA limited the Agency's flexibility to exclude many requirements. It described in detail its requirements for subpart C, concerning the hazard analysis and risk-based preventive controls part of the proposed rule. Alternatives include certain requirements listed in subpart B concerning operations and practices. Costs and Benefits: The benefits of the proposed rule would result from fewer cases of contaminated animal food ingredients or finished animal food products. Discovering contaminated food ingredients before they are used in a finished product would reduce the number of recalls of contaminated animal food products. Benefits would include reduced medical treatment costs for animals and humans, reduced loss of market value of live animals, reduced loss of animal companionship, and reduced loss in value of animal food products. More stringent requirements for animal food manufacturing would maintain public confidence in the safety of animal foods and protect animal and human health. FDA lacks sufficient data to quantify the benefits of the proposed rule. The compliance costs of the proposed rule would result from the additional labor and capital required to perform the hazard analyses, write and implement the preventive controls, monitor and verify the preventive controls, take corrective actions if preventive controls fail to prevent feeds from becoming contaminated, and implement requirements from the operations and practices section. Risks: FDA is proposing this rule to provide greater assurance that food intended for animals is safe and will not cause illness or injury to animals or humans. This rule would implement a risk-based, preventive controls food safety system intended to prevent animal food containing hazards, which may cause illness or injury to animals or humans, from entering into the food supply. The rule would apply to domestic and imported animal food (including raw materials and ingredients). Fewer cases of animal food contamination would (1) reduce the risk of serious illness and death to animals, (2) reduce the risk of adverse health effects to humans handling animal food, and (3) reduce the risk of consuming human food from animals that consumed contaminated food. Timetable:
Regulatory Flexibility Analysis Required: Business Government Levels Affected: No Federalism: No International Impacts: This regulatory action will be likely to have international trade and investment effects, or otherwise be of international interest. Agency Contact: Kim Young Deputy Director, Division of Compliance Department of Health and Human Services Food and Drug Administration Center for Veterinary Medicine Room 106 (MPN-4, HFV-230) 7519 Standish Place Rockville , MD 20855 Phone: 240 276-9207 E-Mail: kim.young@fda.hhs.gov
Title: Over-the-Counter (OTC) Drug Review-Pediatric Dosing for Cough/Cold Products Abstract: The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safe 32
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and effective and not misbranded. After a final monograph (i.e., final rule) is issued, only OTC drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. This action will propose changes to the final monograph to address safety and efficacy issues associated with pediatric cough and cold products. Priority: Economically Significant Agenda Stage of Rulemaking: Proposed Rule Unfunded Mandates: Private Sector Major: Yes CFR Citation: 21 CFR 201; 21 CFR 310; 21 CFR 330 to 358 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 360; 21 USC 371 Legal Deadline: None Timetable:
Regulatory Flexibility Analysis Required: Business Government Levels Affected: Local; State Federalism: Yes Energy Affected: No International Impacts: This regulatory action will be likely to have international trade and investment effects, or otherwise be of international interest. Related RINs: Related to 0910-AF31; Related to 0910AF32; Related to 0910-AF33; Related to 0910-AF34 Agency Contact: Mary Chung Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research WO 22, Room 5488 10903 New Hampshire Avenue Silver Spring , MD 20993 Phone: 301 796-0260 FAX: 301 796-9899 E-Mail: mary.chung@fda.hhs.gov
Title: New Animal Drugs: Updating Tolerances for Residues in New Animal Drugs in Food Abstract: FDA is proposing to revise 21 CFR 556 to reformat the listings of tolerances for residues of approved new animal drugs in food. Currently, part 556 employs a patchwork of various styles for listing tolerances that have evolved over the past 40 years as each additional animal drug has been approved. The listings in part 556 are not uniform in format, and do not always provide relevant information in a consistent manner. For example, FDA provides the acceptable daily intake (ADI) and safe concentrations for some, but not all drugs; FDA lists some tolerances as being for "negligible" residues; and FDA presents some listings in a text paragraph format while others are presented in outline form. Moreover, sometimes FDA specifies "no residue," "zero tolerance," or tolerance "not required," but does not define or make distinction between these important terms. This revision will standardize, simplify, and clarify these listings and improve the readability of the regulations. Priority: Routine and Frequent Agenda Stage of Rulemaking: Proposed Rule Unfunded Mandates: No Major: No CFR Citation: 21 CFR 556 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: 21 USC 342; 21 USC 360b; 21 USC 371 Legal Deadline: None Timetable:
Regulatory Flexibility Analysis Required: No Small Entities Affected: No Energy Affected: No Agency Contact: Dong Yan
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Biologist Department of Health and Human Services Food and Drug Administration Center for Veterinary Medicine Room E464 (MPN-2, HFV-151) 7500 Standish Place Rockville , MD 20855 Phone: 240 276-8117 E-Mail: dong.yan@fda.hhs.gov
Title: Electronic Distribution of Content of Labeling for Human Prescription Drug and Biological Products Abstract: This rule would require electronic package inserts for human drug and biological prescription products with limited exception, in lieu of paper, which is currently used. These inserts contain prescribing information intended for healthcare practitioners. This would ensure that the information accompanying the product is the most up-to-date information regarding important safety and efficacy issues about these products. Agenda Stage of Rulemaking: Proposed Rule Priority: Economically Significant Major: Yes Unfunded Mandates: Private Sector CFR Citation: 21 CFR 201.100; 21 CFR 201.306; 21 CFR 201.310 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: 21 USC 321; 21 USC 331; 21 USC 351; 21 USC 352; 21 USC 353; 21 USC 355; 21 USC 358; 21 USC 360; 21 USC 360b; 21 USC 360gg to 360ss; 21 USC 371; 21 USC 374; 21 USC 379e; 42 USC 216; 42 USC 241; 42 USC 262; 42 USC 264 Legal Deadline: None Timetable:
Regulatory Flexibility Analysis Required: Business Government Levels Affected: No Federalism: No Energy Affected: No Agency Contact: Megan Clark-Velez Policy Analyst Department of Health and Human Services Food and Drug Administration Office of Policy WO Building 32, Room 4249 10903 New Hampshire Avenue Silver Spring , MD 20993 Phone: 301 796-9301 E-Mail: megan.clark@fda.hhs.gov
Title: Amendment to the Current Good Manufacturing Practice Regulations for Finished Pharmaceuticals--Second Phase Abstract: The Food and Drug Administration (FDA) periodically reassesses and revises the cGMP regulations to accommodate advances in technology and other scientific knowledge that further safeguard the drug manufacturing process and the public health. In August 2002, FDA announced the Pharmaceutical cGMPs for the 21st Century Initiative. As part of the Initiative, FDA created a cGMP Harmonization Analysis Working Group to analyze related cGMP requirements in the United States and internationally. The cGMP working group compared 21 CFR parts 210 and 211 with the cGMPs of the European Union, as well as other FDA regulations (such as the Quality Systems Regulation in 21 CFR part 820) to identify differences and consider the value of supplementing or changing the current regulations. Based on the cGMP Working Group's analysis, FDA decided to take an incremental approach to modifying 21 CFR parts 210 and 211. In September of 2008, FDA published a final rule revising the cGMP regulations primarily in the areas of aseptic processing, use of asbestos filters, and verification of operations by a second
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individual; this final rule represented the culmination of the first increment of modifications to the cGMP regulations. The proposed rule identified on this Unified Agenda would begin the second increment of modifications to the cGMP regulations. Priority: Other Significant Agenda Stage of Rulemaking: Proposed Rule Unfunded Mandates: Undetermined Major: Undetermined CFR Citation: 21 CFR 210; 21 CFR 211 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: 21 USC 321; 21 USC 351; 21 USC 352; 21 USC 355; 21 USC 360b; 21 USC 371; 21 USC 374; 42 USC 262; 42 USC 264 Legal Deadline: None Timetable:
Regulatory Flexibility Analysis Required: Business Government Levels Affected: No Federalism: No Energy Affected: Undetermined International Impacts: This regulatory action will be likely to have international trade and investment effects, or otherwise be of international interest. Agency Contact: S. Mitchell Weitzman Regulatory Counsel, Office of Regulatory Policy Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research WO 51, Room 6318 10903 New Hampshire Avenue Silver Spring , MD 20993 Phone: 301 796-3511 FAX: 301 847-8440 E-Mail: smitchell.weitzman@fda.hhs.gov
Title: 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 Abstract: The Food and Drug Administration (FDA) is proposing to amend certain regulations relating to citizen petitions, petitions for stay of action, and the submission of documents to the agency. We are making these changes to implement certain provisions of section 914 of title IX of the Food and Drug Administration Amendments Act, which added section 505(q) to the Federal Food, Drug, and Cosmetic Act (the Act). Priority: Other Significant Agenda Stage of Rulemaking: Proposed Rule Major: No Unfunded Mandates: No CFR Citation: 21 CFR 10.20; 21 CFR 10.30; 21 CFR 10.31; 21 CFR 10.35 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: 21 USC 321; 21 USC 505 Legal Deadline: None Timetable:
Regulatory Flexibility Analysis Required: No Federalism: No Energy Affected: No Agency Contact: Nicole K. Mueller Regulatory Counsel Department of Health and Human Services Food and Drug Administration
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Center for Drug Evaluation and Research WO 51, Room 6312 10903 New Hampshire Avenue Silver Spring , MD 20993-0002 Phone: 301 796-3507 FAX: 301 827-8440 E-Mail: nicole.mueller@fda.hhs.gov
Title: Unique Device Identification Abstract: The Food and Drug Administration Amendments Act of 2007 (FDAAA), amended the Federal Food, Drug, and Cosmetic Act by adding section 519(f) (21 U.S.C. 360i(f)). This section requires FDA to promulgate regulations establishing a unique identification system for medical devices requiring the label of medical devices to bear a unique identifier, unless FDA specifies an alternative placement or provides for exceptions. The unique identifier must adequately identify the device through distribution and use, and may include information on the lot or serial number. Priority: Economically Significant Agenda Stage of Rulemaking: Proposed Rule Major: Yes Unfunded Mandates: No CFR Citation: 21 CFR 16; 21 CFR 801; 21 CFR 803; 21 CFR 806; 21 CFR 810; 21 CFR 814; 21 CFR 820; 21 CFR 821; 21 CFR 822 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: Not Yet Determined Legal Deadline: None Regulatory Plan: Statement of Need: A unique device identification system will help reduce medical errors; will allow FDA, the healthcare community, and industry to more rapidly review and organize adverse event reports; identify problems relating to a particular device (even down to a particular lot or batch, range of serial numbers, or range of manufacturing or expiration dates); and thereby allow for more rapid, effective, corrective actions that focus sharply on the specific devices that are of concern. Legal Basis: Section 519(f) of the FD&C Act (added by sec. 226 of the Food and Drug Administration Amendments Act of 2007) directs the Secretary to promulgate regulations establishing a unique device identification (UDI) system for medical devices, requiring the label of devices to bear a unique identifier that will adequately identify the device through its distribution and use. Alternatives: FDA considered several alternatives that would allow certain requirements of the proposed rule to vary, such as the required elements of a UDI and the scope of affected devices. Costs and Benefits: FDA estimates that the affected industry would incur one-time and recurring costs, including administrative costs, to change and print labels that include the required elements of a UDI, costs to purchase equipment to print and verify the UDI, and costs to purchase software and integrate and validate the UDI into existing IT systems. FDA anticipates that implementation of a UDI system would help improve the efficiency and accuracy of medical device recalls and medical device adverse event reporting. The proposed rule would also standardize how medical devices are identified and contribute to future potential public health benefits of initiatives aimed at optimizing the use of automated systems in healthcare. Most of these benefits, however, require complementary developments and innovations in the private and public sectors. Risks: This rule is intended to substantially eliminate existing obstacles to the consistent identification of medical devices used in the Unites States. By providing the means to rapidly and accurately identify a device and key attributes that affect its safe and effective use, the rule would reduce medical errors that result from misidentification of a device or confusion concerning its appropriate use. The rule will fulfill a statutory directive to establish a unique device identification system. Timetable:
Regulatory Flexibility Analysis Required: Business Federalism: Undetermined Energy Affected: No Agency Contact: John J. Crowley Senior Advisor for Patient Safety Department of Health and Human Services
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Food and Drug Administration Center for Devices and Radiological Health WO 66, Room 2315 10903 New Hampshire Avenue Silver Spring , MD 20993 Phone: 301 980-1936 E-Mail: jay.crowley@fda.hhs.gov
Title: Produce Safety Regulation Abstract: The Food Safety Modernization Act requires the Secretary to establish and publish science-based minimum standards for the safe production and harvesting of those types of fruits and vegetables, including specific mixes or categories of fruits and vegetables, that are raw agricultural commodities for which the Secretary has determined that such standards minimize the risk of serious adverse health consequences or death. FDA is proposing to promulgate regulations setting enforceable standards for fresh produce safety at the farm and packing house. The purpose of the proposed rule is to reduce the risk of illness associated with contaminated fresh produce. The proposed rule will be based on prevention-oriented public health principles and incorporate what we have learned in the past decade since the Agency issued general good agricultural practice guidelines entitled "Guide to Minimize Microbial Food Safety Hazards for Fresh Fruits and Vegetables" (GAPs Guide). The proposed rule also will reflect comments received on the Agency's 1998 update of its GAPs guide and its July 2009 draft commodity specific guidances for tomatoes, leafy greens, and melons. Although the proposed rule will be based on recommendations that are included in the GAPs guide, FDA does not intend to make the entire guidance mandatory. FDA's proposed rule would, however, set out clear standards for implementation of modern preventive controls. The proposed rule also would emphasize the importance of environmental assessments to identify hazards and possible pathways of contamination and provide examples of risk reduction practices recognizing that operators must tailor their preventive controls to particular hazards and conditions affecting their operations. The requirements of the proposed rule would be scale appropriate and commensurate with the relative risks and complexity of individual operations. FDA intends to issue guidance to assist industry in complying with the requirements of the new regulation. Priority: Economically Significant Agenda Stage of Rulemaking: Proposed Rule Major: Yes Unfunded Mandates: Private Sector CFR Citation: Not Yet Determined (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: 21 USC 342; 21 USC 350h; 21 USC 371; 42 USC 264; PL 111-353 (signed on Jan. 4, 2011) Legal Deadline:
Action NPRM Source Statutory Description Proposed rule not later than 12 months after the date of enactment of the Food Safety Modernization Act. Date 01/04/2012
Regulatory Plan: Statement of Need: FDA is taking this action to meet the requirements of the FSMA and to address the food safety challenges associated with fresh produce and thereby protect the public health. Data indicate that between 1973 and 1997, outbreaks of foodborne illness in the U.S. associated with fresh produce increased in absolute numbers and as a proportion of all reported foodborne illness outbreaks. The Agency issued general good agricultural practice guidelines for fresh fruits and vegetables over a decade ago. Incorporating prevention-oriented public heath principles and incorporating what we have learned in the past decade into a regulation is a critical step in establishing standards for the growing, harvesting, packing, and storing of produce and reducing the foodborne illness attributed to fresh produce. Legal Basis: FDA is relying on the amendments to the Federal Food, Drug, and Cosmetic Act (the FD&C Act), provided by section 105 of the Food Safety Modernization Act (codified primarily in sec. 419 of the FD&C Act (21 U.S.C. 350h)). FDA's legal basis also derives in part from sections 402(a)(4) and 701(a) of the FD&C Act (21 U.S.C. 342(a)(4) and 371(a)). FDA also intends to rely on section 361 of the Public Health Service Act (PHS Act) (42 U.S.C. 264), which gives FDA authority to promulgate regulations to control the spread of communicable disease. Alternatives: Section 105 of the Food Safety Modernization Act requires FDA to conduct this rulemaking. Costs and Benefits: FDA estimates that the costs to more than 300,000 domestic and foreign producers and packers of fresh produce from the proposal would include one-time costs (e.g., new tools and equipment) and recurring costs (e.g., monitoring, training, recordkeeping). FDA anticipates that the benefits would be a reduction in foodborne illness and deaths associated with fresh produce. Monetized estimates of costs and benefits are not available at this time. Risks: This regulation would directly and materially advance the Federal Government's substantial interest in reducing the 37
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risks for illness and death associated with foodborne infections associated with the consumption of fresh produce. Less restrictive and less comprehensive approaches have not been sufficiently effective in reducing the problems addressed by this regulation. FDA anticipates that the regulation would lead to a significant decrease in foodborne illness associated with fresh produce consumed in the U.S. Timetable:
Regulatory Flexibility Analysis Required: Business Government Levels Affected: No Federalism: Undetermined International Impacts: This regulatory action will be likely to have international trade and investment effects, or otherwise be of international interest. Agency Contact: Samir Assar Supervisory Consumer Safety Officer Department of Health and Human Services Food and Drug Administration Center for Food Safety and Applied Nutrition Office of Food Safety 5100 Paint Branch Parkway College Park , MD 20740 Phone: 240 402-1636 E-Mail: samir.assar@fda.hhs.gov
Title: Hazard Analysis and Risk-Based Preventive Controls Abstract: The Food and Drug Administration (FDA) Food Safety Modernization Act (the FSMA) requires the Secretary of Health and Human Services to promulgate regulations to establish science-based minimum standards for conducting a hazard analysis, documenting hazards, implementing preventive controls, and documenting the implementation of the preventive controls; and to define the terms "small business" and "very small business." The FSMA also requires the Secretary to promulgate regulations with respect to activities that constitute on-farm packing or holding of food that is not grown, raised, or consumed on a farm or another farm under the same ownership and activities that constitute on farm manufacturing or processing of food that is not grown, raised, or consumed on a farm or another farm under the same ownership. FDA is proposing to amend its current good manufacturing practice (CGMP) regulations (21 CFR part 110) for manufacturing, packing, or holding human food to require food facilities to develop and implement a written food safety plan. This proposed rule would require a food facility to have and implement preventive controls to significantly minimize or prevent the occurrence of hazards that could affect food manufactured, processed, packed, or held by the facility and to provide assurances that such food will not be adulterated under section 402 or misbranded under section 403(w). Priority: Economically Significant Agenda Stage of Rulemaking: Proposed Rule Unfunded Mandates: No Major: Yes CFR Citation: 21 CFR 110 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: 21 USC 342; 21 USC 371; 42 USC 264; PL 111-353 (signed on Jan. 4, 2011) Legal Deadline: Not later than 9 months after the date of enactment of the FDA Food Safety Modernization Act.
Action Other Source Statutory Description Final rule must be published no later than 18 months after the date of enactment of the FDA Food Safety Modernizaton Act. Date 07/04/2012
Regulatory Plan: Statement of Need: FDA is taking this action to meet the requirements of the FSMA and to better address changes that have occurred in the food industry and thereby protect public health. FDA last updated its food CGMP regulations for the manufacturing, packing, or holding of human food in 1986. Modernizing these food CGMP regulations to address risk-based preventive controls and more explicitly address issues such as environmental pathogens, food allergens, mandatory employee training, and sanitation of food contact surfaces, would be a critical step in raising the standards for food production and distribution. By amending 21 CFR 110 to modernize good manufacturing practices, the agency could focus the attention of food processors on measures that have been proven to significantly reduce the risk of food-borne illness. An amended regulation also would allow the agency to better focus its regulatory efforts on ensuring industry compliance with controls that have a significant food safety impact. Legal Basis: FDA is relying on section 103 of the FSMA. FDA is also relying on sections 402(a)(3), (a)(4) and 701(a) of the 38
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Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 342(a)(3), (a)(4), and 371(a)). Under section 402(a)(3) of the FD&C Act, a food is adulterated if it consists in whole or in part of any filthy, putrid, or decomposed substance, or if it is otherwise unfit for food. Under section 402(a)(4), a food is adulterated if it has been prepared, packed, or held under unsanitary conditions whereby it may have become contaminated with filth or may have been rendered injurious to health. Under section 701(a) of the FD&C Act, FDA is authorized to issue regulations for the efficient enforcement of the FD&C Act. FDA's legal basis also derives from section 361 of the Public Health Service Act (PHS Act) (42 U.S.C. 264), which gives FDA authority to promulgate regulations to control the spread of communicable disease. Alternatives: An alternative to this rulemaking is not to update the CGMP regulations, and instead issue separate regulations to implement the FDA Food Safety Modernization Act. Costs and Benefits: FDA estimates that the costs from the proposal to domestic and foreign producers and packers of processed foods would include new one-time costs (e.g., adoption of written food safety plans, setting up training programs, implementing allergen controls, and purchasing new tools and equipment) and recurring costs (e.g., auditing and monitoring suppliers of sensitive raw materials and ingredients, training employees, and completing and maintaining records used throughout the facility). FDA anticipates that the benefits would be a reduced risk of food-borne illness and death from processed foods and a reduction in the number of safety related recalls. Risks: This regulation will directly and materially advance the Federal Government's substantial interest in reducing the risks for illness and death associated with food-borne infections. Less restrictive and less comprehensive approaches have not been effective in reducing the problems addressed by this regulation. The regulation will lead to a significant decrease in foodborne illness in the U.S. Timetable:
Regulatory Flexibility Analysis Required: Business Government Levels Affected: No Federalism: Undetermined International Impacts: This regulatory action will be likely to have international trade and investment effects, or otherwise be of international interest. Agency Contact: John F. Sheehan Director, Office of Food Safety, Division of Plant and Dairy Food Safety Department of Health and Human Services Food and Drug Administration Center for Food Safety and Applied Nutrition (HFS-315) 5100 Paint Branch Parkway College Park , MD 20740 Phone: 240 402-1488 FAX: 301 436-2632 E-Mail: john.sheehan@fda.hhs.gov
Title: Additions to the List of Tropical Diseases in Section 524 of the Federal Food, Drug, and Cosmetic Act Abstract: Section 524 of the Federal Food, Drug, and Cosmetic Act (21 USC 360n), "Priority Review to Encourage Treatments for Tropical Diseases," provides authority for the Food and Drug Administration to award to the sponsor of a tropical disease product application, defined in section 524(a)(4), a priority review voucher, entitling the sponsor to priority review of a single human drug application that is unrelated to the tropical disease product application. The term "tropical disease" means any of the diseases listed in section 524(a)(3), and "any other infectious disease for which there is no significant market in developed nations and that disproportionately affects poor and marginalized populations, designated by regulation by the Secretary." The proposed rule will designate tropical diseases to be added to the list in accordance with section 524(a)(3)(Q). Priority: Other Significant Agenda Stage of Rulemaking: Proposed Rule Unfunded Mandates: No Major: No CFR Citation: Not Yet Determined (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: 21 USC 360n Legal Deadline: None Timetable:
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Date 03/00/2012 FR Cite
Unified Agenda
Regulatory Flexibility Analysis Required: No Government Levels Affected: No Federalism: No Small Entities Affected: No Energy Affected: No International Impacts: This regulatory action will be likely to have international trade and investment effects, or otherwise be of international interest. Agency Contact: Kristiana Brugger Regulatory Counsel Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research 10903 New Hampshire Avenue WO 51, Room 6262 Silver Spring , MD 20993 Phone: 301 796-2897 FAX: 301 847-8440 E-Mail: kristiana.brugger@fda.hhs.gov
Title: "Tobacco Products" Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act Abstract: The Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) provides FDA authority to regulate cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco. Section 901 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Tobacco Control Act, permits FDA to issue regulations deeming other tobacco products to be subject to the FD&C Act. This proposed rule would deem products meeting the statutory definition of "tobacco product" found at section 201(rr) of the FD&C Act to be subject to Chapter IX of the FD&C Act and would clarify additional restrictions under the FD&C Act. The scope of the proposed rule deeming cigars that was previously included in the Unified Agenda is being broadened to encompass products that meet the statutory definition of "tobacco product." Priority: Economically Significant Agenda Stage of Rulemaking: Proposed Rule Unfunded Mandates: Undetermined Major: Yes CFR Citation: Not Yet Determined (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: 21 USC 301 et seq, The Federal Food, Drug, and Cosmetic Act; PL 111-31, The Family Smoking Prevention and Tobacco Control Act Legal Deadline: None Timetable:
Regulatory Flexibility Analysis Required: Business Government Levels Affected: Undetermined Federalism: Undetermined International Impacts: This regulatory action will be likely to have international trade and investment effects, or otherwise be of international interest. Agency Contact: May Nelson Regulatory Counsel Department of Health and Human Services Food and Drug Administration 9200 Corporate Boulevard Rockville , MD 20850 Phone: 877 287-1373 FAX: 240 276-3904 E-Mail: may.nelson@fda.hhs.gov
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Title: Amendment to Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco To Protect Children and Adolescents Abstract: Section 102 of the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) requires the Secretary to publish a final rule regarding cigarettes and smokeless tobacco identical in its provisions to the regulations promulgated by FDA in 1996 (61 FR 44396, August 28, 1996) (1996 final rule), with certain specified exceptions. In the reissued 1996 rule, 21 CFR 1140.16(a) is identical to section 897.16(a) in the 1996 final rule. Section 102(a)(3) and (4) of the Tobacco Control Act give FDA the authority to amend the rule in accordance with the Administrative Procedure Act (5 U.S.C. Chapter 5). FDA is proposing to amend 21 CFR 1140.16(a), which became effective June 22, 2010, to allow the manufacturer of a cigarette or smokeless tobacco product with a trade or brand name that is also the trade or brand name of a nontobacco product to continue to use the name if the tobacco product was sold in the United States on or before June 22, 2009. FDA also is proposing to amend the regulation to ensure that a manufacturer of a cigarette or smokeless tobacco product may continue to use its trade or brand name even if that name is subsequently registered with the United States Patent and Trademark Office or subsequently used for a nontobacco product. Priority: Other Significant Agenda Stage of Rulemaking: Proposed Rule Unfunded Mandates: No Major: No CFR Citation: 21 CFR 1140 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: 21 USC 301 et seq, The Federal Food, Drug, and Cosmetic Act; PL 111-31, The Family Smoking Prevention and Tobacco Control Act Legal Deadline: None Timetable:
Regulatory Flexibility Analysis Required: Undetermined Federalism: No Related RINs: Related to 0910-AG33 Agency Contact: Gail L. Schmerfeld Senior Regulatory Counsel Department of Health and Human Services Food and Drug Administration 9200 Corporate Boulevard Rockville , MD 20850-3229 Phone: 877 287-1373 FAX: 240 276-3904 E-Mail: gail.schmerfeld@fda.hhs.gov
Title: Human Subject Protection; Acceptance of Data From Clinical Studies for Medical Devices Abstract: The Food and Drug Administration (FDA) is proposing to amend its regulations on acceptance of data from clinical studies conducted in support of a premarket approval application, humanitarian device exemption application, an investigational device exemption application, or a premarket notification submission for a medical device. Priority: Other Significant Agenda Stage of Rulemaking: Proposed Rule Unfunded Mandates: No Major: No CFR Citation: Not Yet Determined (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: Not Yet Determined Legal Deadline: None
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Action NPRM
Unified Agenda
Date 04/00/2012
FR Cite
Regulatory Flexibility Analysis Required: Business Government Levels Affected: No Federalism: No International Impacts: This regulatory action will be likely to have international trade and investment effects, or otherwise be of international interest. Agency Contact: Sheila Anne Brown Policy Analyst, Investigational Device Exemptions Staff Department of Health and Human Services Food and Drug Administration WO 66, Room 1651 10903 New Hampshire Avenue Silver Spring , MD 20993 Phone: 301 796-6563 FAX: 301 847-8120 E-Mail: sheila.brown@fda.hhs.gov
Title: General Hospital and Personal Use Devices: Issuance of Draft Special Controls Guidance for Infusion Pumps Abstract: Since 2003, FDA has seen a dramatic increase in the number of device recalls, as well as an increase in the number of death and serious injury reports submitted regarding infusion pumps. An analysis of the reports reveals that a majority of the recalls and failures were caused by user error and/or device design flaw. As a result of these incidents, FDA is proposing to change the classification of infusion pumps from class II (performance standards) to class II (special controls). Along with the proposed rule, FDA plans to announce a draft special controls guidance document that, when final, will be a special control for infusion pumps. The agency believes that establishing these special controls for infusion pumps is necessary to provide reasonable assurance of the safety and effectiveness of these devices. Priority: Other Significant Agenda Stage of Rulemaking: Proposed Rule Major: Undetermined Unfunded Mandates: No CFR Citation: 21 CFR 880.5725 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: 21 USC 351; 21 USC 360; 21 USC 360c; 21 USC 360e; 21 USC 360j; 21 USC 371 Legal Deadline: None Timetable:
Regulatory Flexibility Analysis Required: Business Government Levels Affected: State Federalism: Yes Energy Affected: No Agency Contact: Nancy Pirt Regulatory Counsel Department of Health and Human Services Food and Drug Administration Center for Devices and Radiological Health WO 66 Room 4438 10903 New Hampshire Avenue Silver Spring , MD 20993 Phone: 301 796-6248 FAX: 301 847-8145 E-Mail: nancy.pirt@fda.hhs.gov
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View Related Documents Title: Requirements for the Testing and Reporting of Tobacco Product Constituents, Ingredients, and Additives Abstract: Section 915 of the Federal Food, Drug, and Cosmetic Act, as amended by the Family Smoking Prevention and Tobacco Control Act, requires FDA to promulgate regulations that require the testing and reporting of tobacco product constituents, ingredients, and additives, including smoke constituents that the agency determines should be tested to protect the public health. Agenda Stage of Rulemaking: Proposed Rule Priority: Other Significant Major: Undetermined Unfunded Mandates: Undetermined CFR Citation: Not Yet Determined (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: PL 111-31, The Family Smoking Prevention and Tobacco Control Act, sec 101(b) Legal Deadline: Final rule must issue no later than 36 months after April 1, 2010--see sec. 915(a) of the Federal Food, Drug, and Cosmetic Act and sec. 6 of the Family Smoking Prevention and Tobacco Control Act.
Action Other Source Statutory Description Sec. 915(a) of the Family Smoking Prevention and Tobacco Control Act Date 04/00/2013
Timetable:
Regulatory Flexibility Analysis Required: Business Federalism: Undetermined Energy Affected: No Agency Contact: Carol Drew Regulatory Counsel Department of Health and Human Services Food and Drug Administration Rm 240 H 9200 Corporate Boulevard Rockville , MD 20850 Phone: 877 287-1373 FAX: 240 276-3904 E-Mail: carol.drew@fda.hhs.gov
Government Levels Affected: Undetermined
Title: Foreign Supplier Verification Program Abstract: The proposed rule would establish regulations concerning the content of foreign supplier verification programs. The regulations will require that each importer have a foreign supplier verification program that is adequate to provide assurances that each foreign supplier produces food in compliance with: (1) Processes and procedures that provide the same level of public health protection as those required under section 418 (concerning hazard analysis and risk-based preventative controls) or section 419 (concerning produce safety standards) of the FD&C Act; and (2) sections 402 (concerning adulteration) and 403(w) (concerning major food allergens) of the FD&C Act. In promulgating the foreign supplier verification regulations, we will, as appropriate, take into account differences among importers and types of imported foods, including differences related to the level of risk posed by an imported food. Methods of foreign supplier verification may include monitoring records for shipments, lot-bylot certifications of compliance, annual on-site inspections, checking the hazard analysis and risk-based preventive control plans of foreign suppliers, and periodically testing and sampling shipments. Agenda Stage of Rulemaking: Proposed Rule Priority: Other Significant Major: Undetermined Unfunded Mandates: Undetermined CFR Citation: Not Yet Determined (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: Title III, sec 301 of FDA Food Safety Modernization Act, PL 111-353, establishing sec 805 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) Legal Deadline:
Action Source Description Date
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01/04/2012
Regulatory Plan: Statement of Need: The proposed rule is needed to help improve the safety of food that is imported into the United States. Imported food products have increased dramatically over the last several decades. Data indicate that about 15% of the U.S. food supply is imported. FSMA provides the Agency with additional tools and authorities to help ensure that imported foods are safe for U.S. consumers. Included among these tools and authorities is a requirement that importers perform risk-based foreign supplier verification activities to verify that the food they import is produced in compliance with U.S. requirements and is not adulterated or misbranded. This proposed rule on the content of foreign supplier verification program (FSVPs) sets forth the proposed steps that food importers would be required to take to fulfill their responsibility to ensure the safety of the food they bring into this country. Legal Basis: Section 805(c) of the FD&C Act (21 U.S.C. 384a(c)) directs FDA, not later than 1 year after the date of enactment of FSMA, to issue regulations on the content of FSVPs. Section 805(c)(4) states that verification activities under such programs may include monitoring records for shipments, lot-by-lot certification of compliance, annual onsite inspections, checking the hazard analysis and risk-based preventive control plans of foreign suppliers, and periodically testing and sampling shipments of imported products. Section 301(b) of FSMA amends section 301 of the FD&C Act (21 U.S.C. 331) by adding section 301(zz), which designates as a prohibited act the importation or offering for importation of a food if the importer (as defined in section 805) does not have in place an FSVP in compliance with section 805. In addition, section 301(c) of FSMA amends section 801(a) of the FD&C Act (21 U.S.C. 381(a)) by stating that an article of food being imported or offered for import into the United States shall be refused admission if it appears from an examination of a sample of such an article or otherwise that the importer is in violation of section 805. Alternatives: We are considering a range of alternative approaches to the requirements for foreign supplier verification activities. These might include: (1) Establishing a general requirement that importers determine and conduct whatever verification activity that would adequately address the risks associated with the foods they import; (2) allowing importers to choose from a list of possible verification mechanisms, such as the activities listed in section 805(c)(4) of the FD&C Act; (3) requiring importers to conduct particular verification activities for certain types of foods or risks (e.g., for high-risk foods) but allowing flexibility in verification activities for other types of foods or risks; and (4) specifying use of a particular verification activity for each particular kind of food or risk. To the extent possible while still ensuring that verification activities are adequate to ensure that foreign suppliers are producing food in accordance with U.S. requirements, we will seek to give importers the flexibility to choose verification procedures that are appropriate to adequately address the risks associated with the importation of a particular food. Costs and Benefits: We have not yet quantified the cost and benefits for this proposed rule. However, the available information suggests that the costs will be significant. Our preliminary analysis of FY10 OASIS data suggests that this rule will cover about 60,000 importers, 240,000 unique combinations of importers and foreign suppliers, and 540,000 unique combinations of importers, products, and foreign suppliers. These numbers imply that provisions that require activity for each importer, each unique combination of importer and foreign supplier, or each unique combination of importer, product, and foreign supplier will generate significant costs. An example of a provision linked to combinations of importers and foreign suppliers would be a requirement to conduct a verification activity, such as an onsite audit, under certain conditions. The cost of onsite audits will depend in part on whether foreign suppliers can provide the same onsite audit results to different importers or whether every importer will need to take some action with respect to each of their foreign suppliers. The benefits of this proposed rule will consist of the reduction of adverse health events linked to imported food that could result from compliance with the FSVP requirements. We have not yet estimated the benefits of the rule. Risks: As stated above, about 15 percent of the U.S. food supply is imported, and many of these imported foods are high-risk commodities. According to recent data from the Centers for Disease Control and Prevention, each year, about 48 million Americans get sick, 128,000 are hospitalized, and 3,000 die from foodborne diseases. From July 1, 2007, through June 30, 2008, FDA oversaw 40 recalls of imported foods that were so contaminated that the Agency deemed them to be an imminent threat. We expect that the adoption of FSVPs by food importers will lead to a significant reduction to the threat to public health posed by unsafe imported food, though we are still in the process of trying to quantify the reduction in risk that will occur through importer compliance with the FSVP regulations. Timetable:
Regulatory Flexibility Analysis Required: Undetermined Government Levels Affected: No Federalism: No Small Entities Affected: Business Energy Affected: No International Impacts: This regulatory action will be likely to have international trade and investment effects, or otherwise be of international interest. Agency Contact: Brian L. Pendleton
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Senior Policy Advisor Department of Health and Human Services Food and Drug Administration Office of Policy WO32, Room 4245 10903 New Hampshire Avenue Silver Spring , MD 20993-0002 Phone: 301 796-4614 FAX: 301 847-8616 E-Mail: brian.pendleton@fda.hhs.gov
Title: Accreditation of Third Parties to Conduct Food Safety Audits and for Other Related Purposes Abstract: The Food and Drug Administration (FDA) is proposing regulations relating to the accreditation of third-party auditors to conduct food safety audits of foreign entities, including foreign facilities in the food import supply chain. The proposed regulations will include provisions to protect against conflicts of interest between accredited auditors and audited entities, as described in section 307 of the FDA Food Safety Modernization Act (FSMA), Public Law 111-353. As part of this rulemaking, FDA may propose regulations relating to the accreditation of third parties to perform related activities, such as conducting laboratory analyses of food, authorized by other sections of FSMA. Agenda Stage of Rulemaking: Proposed Rule Priority: Other Significant Major: No Unfunded Mandates: No CFR Citation: Not Yet Determined (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: PL 111-353, sec 307, FDA Food Safety Modernization Act; Other sections of FDA Food Safety Modernization Act, as appropriate Legal Deadline: Per Public Law 111-353, section 307(c)(5)(C), promulgate, within 18 months of enactment, implementing regulations for accreditation of third-party auditors to conduct food safety audits.
Action Other Source Statutory Description Promulgate implementing regulations Date 07/00/2012
Regulatory Plan: Statement of Need: The use of accredited third-party auditors to certify high-risk food imports to assist in ensuring the safety of food from foreign origin entering U.S. commerce. Accredited third-party auditors auditing foreign process facilities may be viewed as increasing FDA's "coverage" of foreign facilities that FDA may not have adequate resources to inspect in a particular year while using identified standards creating overall uniformity to complete the task. Audits that result in issuance of facility certificates will provide FDA information about the compliance status of the facility. Additionally, auditors will be required to submit audit reports that may be reviewed by FDA for purposes of compliance assessment and work planning. Legal Basis: Not later than 2 years after the date of enactment, establish a system for the recognition of accreditation bodies that accredit third-party auditors, certifying that their eligible entities meet the requirements, directly accredit third-party auditors should none be identified and recognized by the 2-year date of enactment, obtain a list of all accredited third-party auditors and their agents from recognized accreditation bodies, and determine requirements for regulatory audit reports while avoiding unnecessary duplication of efforts and costs. Alternatives: FSMA described in detail the framework for, and requirements of, the accredited third-party auditor program. Alternatives include certain oversight activities required of recognized accreditation bodies that accredit third-party auditors, as distinguished from third-party auditors directly accredited by FDA. Another alternative relates to the nature of the required standards and the degree to which those standards are prescriptive or flexible. Costs and Benefits: The benefits of the proposed rule would result from fewer cases of unsafe or misbranded food entering U.S. commerce. Additional benefits include the increased flow of credible information to FDA regarding the compliance status of foreign firms and their foods that are ultimately offered for import Into the United States, which information in turn would inform FDA's work planning for inspection of foreign food facilities and might result in a signal of possible problems with a particular firm or its products, and with sufficient signals, might raise questions about the rigor of the food safety regulatory system of the country of origin. The compliance costs of the proposed rule would result from the additional labor and capital required of accreditation bodies seeking FDA recognition and of third-party auditors seeking accreditation to the extent that will involve the assembling of information for an application unique to the FDA third-party program. The compliance costs associated with certification will be accounted for separately under the costs associated with participation In the foreign supplier verification program and the costs associated with mandatory certification for high-risk food imports. The third-party program is funded
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through revenue neutral user fees, which will be developed by FDA through rulemaklng. User fee costs will be accounted for in that rulemaklng. Risks: FDA is proposing this rule to provide greater assurance the food offered for import into the United States is safe and will not cause injury or illness to animals or humans. The rule would implement a program for accrediting third-party auditors to conduct food safety audits of foreign food entities, including registered foreign food facilities, and based on the findings of the regulatory audit, to issue certifications to foreign food entities found to be in compliance with FDA requirements. The certifications would be used by importers seeking to participate in the Voluntary Qualified Importer Program for expedited review and entry of product and would be a means to provide assurance of compliance as required by FDA based on risk-related considerations. The rule would apply to any foreign or domestic accreditation body seeking FDA recognition, any foreign or domestic third-party auditor seeking accreditation, any registered foreign food facility or other foreign food entity subject to a food safety audit (including a regulatory audit conducted for purposes of certification), and any importer seeking to participate in the Voluntary Qualified Importer Program. Fewer cases of unsafe or misbranded food entering U.S. commerce would reduce the risk of serious illness and death to humans and animals. Timetable:
Regulatory Flexibility Analysis Required: No Government Levels Affected: Undetermined Federalism: No Energy Affected: No International Impacts: This regulatory action will be likely to have international trade and investment effects, or otherwise be of international interest. Agency Contact: Charlotte A. Christin Senior Policy Advisor Department of Health and Human Services Food and Drug Administration Office of Policy WO32, Room 4234 10903 New Hampshire Avenue Silver Spring , MD 20993 Phone: 301 796-4718 FAX: 301 847-3541 E-Mail: charlotte.christin@fda.hhs.gov
Title: Amendments to the Current Good Manufacturing Practice Regulations for Finished Pharmaceuticals--Components Abstract: This rule proposes to amend regulations regarding the control over components used in manufacturing finished pharmaceuticals. Priority: Economically Significant Agenda Stage of Rulemaking: Proposed Rule Unfunded Mandates: Undetermined Major: Yes CFR Citation: 21 CFR 210 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: 21 USC 321; 21 USC 351; 21 USC 352; 21 USC 355; 21 USC 360b; 21 USC 371; 21 USC 374; 42 USC 262; 42 USC 264 Legal Deadline: None Timetable:
Regulatory Flexibility Analysis Required: Business Government Levels Affected: Federal Federalism: No International Impacts: This regulatory action will be likely to have international trade and investment effects, or otherwise be of international interest. Agency Contact: Brian Hasselbalch Consumer Safety Officer Department of Health and Human Services 46
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Food and Drug Administration Center for Drug Evaluation and Research WO 51, Room 4364 10903 New Hampshire Avenue Silver Spring , MD 20993 Phone: 301 796-3279 E-Mail: brian.hasselbalch@fda.hhs.gov Agency Contact: Paula Katz Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research WO 51, Room 1320 10903 New Hampshire Avenue Silver Spring , MD 20993 Phone: 301 796-6972 E-Mail: paula.katz@fda.hhs.gov
Title: Orphan Drug Regulations Abstract: FDA is proposing to amend the orphan drug regulations (21 CFR Part 316) to clarify issues that have arisen since those regulations were first issued in 1992. These proposed revisions are intended to assist sponsors who are seeking or who have obtained orphan-drug designation for their drugs. The revisions would clarify agency policy regarding, for example, eligibility for orphan-drug designations, eligibility for multiple orphan-drug exclusive approvals, the requirement for demonstrating clinical superiority, and the timing of request for designations. Priority: Substantive, Nonsignificant Agenda Stage of Rulemaking: Proposed Rule Major: No Unfunded Mandates: No CFR Citation: 21 CFR 316 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: 21 USC 360aa; 21 USC 360bb; 21 USC 360cc; 21 USC 360dd; 21 USC 371 Legal Deadline: None Timetable:
Regulatory Flexibility Analysis Required: No Government Levels Affected: No Small Entities Affected: No Federalism: No Agency Contact: Henry "Chip" Startzman Department of Health and Human Services Food and Drug Administration WO 32, Room 5280 10903 New Hampshire Avenue Silver Spring , MD 20993 Phone: 301 796-8663 E-Mail: henry.startzman@fda.hhs.gov
Title: Use of Symbols in Labeling Abstract: The purpose of this proposed rule is to implement section 502(c)of the FD&C Act and to revise 21 CFR 801.15 (prominence of required label statements) using the authority under section 514(c) of the FD&C Act to allow for the inclusion of standardized symbols recognized by FDA for use on the labeling of medical devices. Priority: Other Significant Agenda Stage of Rulemaking: Proposed Rule Unfunded Mandates: No Major: No CFR Citation: 21 CFR 801.15(c)(1) (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: sec 502(c) of the Food Drug and Cosmetic Act (FD&C Act), 21 USC 352(c); sec 514(c) of FD&C Act, 21 USC 360d(c), enacted by the Food and Drug Modernization Act of 1997 (FDAMA) 47
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Legal Deadline: None Timetable:
Action NPRM
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Date 06/00/2012
FR Cite
Regulatory Flexibility Analysis Required: Undetermined Government Levels Affected: No Federalism: No Energy Affected: No Agency Contact: Mary Follette Story Department of Health and Human Services Food and Drug Administration Center for Devices and Radiological Health Room 2553 10903 New Hampshire Avenue Silver Spring , MD 20993 Phone: 301 796-1456 E-Mail: molly.story@fda.hhs.gov
Title: Effective Date of Requirement for Premarket Approval for Two Class III Preamendments Devices Abstract: The Food and Drug Administration is proposing to require the filing of a premarket approval application (PMA) or a notice of completion of a product development protocol (PDP) for the following two class III preamendments devices: hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis. Priority: Economically Significant Agenda Stage of Rulemaking: Proposed Rule Major: Yes Unfunded Mandates: No CFR Citation: 21 CFR 888.3320; 21 CFR 888.3330 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: 21 USC 360e(b)(1); sec 515(b)(1) of the Federal Food, Drug, and Cosmetic Act Legal Deadline: None Timetable:
Regulatory Flexibility Analysis Required: No Government Levels Affected: No Federalism: No Agency Contact: Michael Ryan Regulatory Advisor Department of Health and Human Services Food and Drug Administration White Oak, Building 66, Room 1615 10903 New Hampshire Avenue Silver Spring , MD 20993 Phone: 301 796-6283 E-Mail: michael.ryan@fda.hhs.gov
Title: Requirements for the Submission of Data Needed to Calculate User Fees for Manufacturers and Importers of Tobacco Products Abstract: Section 919 of the Federal Food, Drug, and Cosmetic Act requires FDA to assess and collect user fees from manufacturers and importers of certain tobacco products. These user fees are allocated based on the market share of specific classes of tobacco products and then the market share of individual manufacturers and importers within each class. Section 919 requires that FDA determine these allocations based on section 625 of Public Law 108-357, which applies to tobacco transition
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assessments that are administered by the U.S. Department of Agriculture (USDA). Currently FDA obtains necessary market share information directly from USDA and uses this information to assess user fees. However, beginning in October 2014 (Fiscal Year 2015), USDA's program sunsets. This proposed rule would require manufacturers and importers of tobacco products to provide FDA with certain data that is currently collected by USDA so that FDA will have the ability to directly calculate market share percentages needed to assess and collect user fees as required in section 919. Priority: Other Significant Agenda Stage of Rulemaking: Proposed Rule Unfunded Mandates: Undetermined Major: Undetermined CFR Citation: 21 CFR 1150 (new) (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: 21 USC 371; 21 USC 387s; PL111-31 Legal Deadline: None Timetable:
Regulatory Flexibility Analysis Required: Undetermined Small Entities Affected: Business Energy Affected: No Agency Contact: Annette L. Marthaler Regulatory Counsel Department of Health and Human Services Food and Drug Administration 9200 Corporate Boulevard, Room 340K Rockville , MD 20850 Phone: 877 287-1373 FAX: 240 276-3904 E-Mail: annette.marthaler@fda.hhs.gov
Title: 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 Abstract: The rule will reorganize, consolidate, clarify, and modify current regulations at 21 CFR part 207 concerning who must register establishments and list human drugs, certain biological drugs, and animal drugs. These regulations contain information on when, how, and where to register drug establishments and list drugs, and what information must be submitted for initial registration and listing and for changes to registration and listing. They also address National Drug Codes and associated labeling. Priority: Other Significant Agenda Stage of Rulemaking: Final Rule Unfunded Mandates: No Major: No CFR Citation: 21 CFR 20; 21 CFR 201 and 207; 21 CFR 314 and 330; 21 CFR 514 to 516; 21 CFR 601 and 607; 21 CFR 610; 21 CFR 1271 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: 21 USC 321 and 331; 21 USC 351 to 353; 21 USC 355 to 356c; 21 USC 360 and 360b; 21 USC 360c to 360f; 21 USC 360h to 360j; 21 USC 371 and 374; 21 USC 379e and 381; 21 USC 393; 15 USC 1451 to 1561; 42 USC 262 and 264; 42 USC 271 Legal Deadline: None Timetable:
Regulatory Flexibility Analysis Required: No Government Levels Affected: No Federalism: No Small Entities Affected: Business International Impacts: This regulatory action will be likely to have international trade and investment effects, or otherwise be of 49
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international interest. Public Comment URL: www.regulations.gov Agency Contact: Sandra Park Regulatory Counsel Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research WO 51, Room 6221 10903 New Hampshire Avenue Silver Spring , MD 20993 Phone: 301 796-0752 FAX: 301 847-8440 E-Mail: sandra.park@fda.hhs.gov
Title: Blood Initiative--Revisions to Labeling Requirements for Blood and Blood Components, Including Source Plasma Abstract: The Food and Drug Administration (FDA) is amending the regulations regarding container labels and instruction circulars for certain human blood and blood components, including Source Plasma, to be more consistent with current practices and to remove unnecessary or outdated requirements. This action is based on FDA's comprehensive review of the biologics regulations. It is also based on reports by the U.S. House of Representatives Committee on Government Reform and Oversight Subcommittee on House Resources and Intergovernmental Relations, the Government Accountability Office (previously, the General Accounting Office), and the Institute of Medicine, as well as on public comments. This action is intended to help ensure the continued safety of the blood supply and to help ensure consistency in container labeling. The rule will also consolidate most of the regulations applicable to labeling standards for blood and blood components, including Source Plasma. For example, most labeling requirements for all blood and blood components, including Source Plasma, found previously in 21 CFR 606.121 and 21 CFR 640.70, will be found in 21 CFR 606.121. Priority: Other Significant Agenda Stage of Rulemaking: Final Rule Unfunded Mandates: No Major: No CFR Citation: 21 CFR 606; 21 CFR 610; 21 CFR 640 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: 21 USC 321; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 360; 21 USC 360d; 21 USC 360h to 360j; 21 USC 371; 21 USC 374; 21 USC 381; 42 USC 216; 42 USC 262 and 263; 42 USC 263a; 42 USC 264 Legal Deadline: None Timetable:
Regulatory Flexibility Analysis Required: No Government Levels Affected: No Small Entities Affected: No Federalism: No Related RINs: Split From 0910-AB26 Agency Contact: Benjamin Chacko Regulatory Counsel Department of Health and Human Services Food and Drug Administration Center for Biologics Evaluation and Research Suite 200N (HFM-17) 1401 Rockville Pike Rockville , MD 20852 Phone: 301 827-6210
Title: Infant Formula: Current Good Manufacturing Practices; Quality Control Procedures; Notification Requirements; Records
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and Reports; and Quality Factors Abstract: The Food and Drug Administration (FDA) is revising its infant formula regulations in 21 CFR parts 106 and 107 to establish requirements for current good manufacturing practices (CGMP), including audits; to establish requirements for quality factors; and to amend FDA's quality control procedures, notification, and record and reporting requirements for infant formula. FDA is taking this action to improve the protection of infants who consume infant formula products. Priority: Other Significant Agenda Stage of Rulemaking: Final Rule Unfunded Mandates: No Major: No CFR Citation: 21 CFR 106 and 107 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: 21 USC 321; 21 USC 350a; 21 USC 371 Legal Deadline: None Regulatory Plan: Statement of Need: The Agency published a proposed rule on July 9, 1996, that would establish current good manufacturing practice regulations, quality control procedures, quality factors, notification requirements, records, and reports for the production of infant formula. This proposal was issued in response to the 1986 Amendments to the Infant Formula Act of 1980. On April 28, 2003, FDA reopened the comment period to update comments on the proposal. The comment was extended on June 27, 2003, and ended on August 26, 2003. The comment period was reopened on August 1, 2006, and ended on September 15, 2006. Legal Basis: The Infant Formula Act of 1980 (the 1980 Act) (Pub. L. 96-359) amended the Federal Food, Drug, and Cosmetic Act (the Act) to include section 412 (21 U.S.C. 350a). This law is intended to improve protection of infants consuming infant formula products by establishing greater regulatory control over the formulation and production of infant formula. In 1982, FDA adopted infant formula recall procedures in subpart D of 21 CFR part 107 of its regulations (47 FR 18832, Apr. 30, 1982), and infant formula quality control procedures in subpart B of 21 CFR part 106 (47 FR 17016, Apr. 20, 1982). In 1985, FDA further implemented the 1980 Act by establishing subparts B, C, and D in 21 CFR part 107 regarding the labeling of infant formula, exempt infant formulas, and nutrient requirements for infant formula, respectively (50 FR 1833, Jan. 14, 1985; 50 FR 48183, Nov. 22, 1985; and 50 FR 45106, Oct. 30, 1985). In 1986, Congress, as part of the Anti-Drug Abuse Act of 1986 (Pub. L. 99570) (the 1986 amendments), amended section 412 of the act to address concerns that had been expressed by Congress and consumers about the 1980 Act and its implementation related to the sufficiency of quality control testing, CGMP, recordkeeping, and recall requirements. The 1986 amendments: (1) State that an infant formula is deemed to be adulterated if it fails to provide certain required nutrients, fails to meet quality factor requirements established by the Secretary (and, by delegation, FDA), or if it is not processed in compliance with the CGMP and quality control procedures established by the Secretary; (2) require that the Secretary issue regulations establishing requirements for quality factors and CGMP, including quality control procedures; (3) require that infant formula manufacturers regularly audit their operations to ensure that those operations comply with CGMP and quality control procedure regulations; (4) expand the circumstances in which firms must make a submission to the Agency to include when there is a major change in an infant formula or a change that may affect whether the formula is adulterated; (5) specify the nutrient quality control testing that must be done on each batch of infant formula; (6) modify the infant formula recall requirements; and (7) give the Secretary authority to establish requirements for retention of records, including records necessary to demonstrate compliance with CGMP and quality control procedures. In 1989, the Agency implemented the provisions on recalls (secs. 412(f) and (g) of the Act) by establishing subpart E in 21 CFR part 107 (54 FR 4006, Jan. 27, 1989). In 1991, the Agency implemented the provisions on record and record retention requirements by revising 21 CFR 106.100 (56 FR 66566, Dec. 24, 1991). The Agency has already promulgated regulations that respond to a number of the provisions of the 1986 amendments. The final rule would address additional provisions of these amendments. Alternatives: The 1986 amendments require the Secretary (and, by delegation, FDA) to establish, by regulation, requirements for quality factors and CGMPs, including quality control procedures. Therefore, there are no alternatives to rulemaking. Costs and Benefits: FDA estimates that the costs from the final rule to producers of infant formula would include first year and recurring costs (e.g., administrative costs, implementation of quality controls, records, audit plans, and assurances of quality factors in new infant formulas). FDA anticipates that the primary benefits would be a reduced risk of illness due to Cronobacter sakazakii and Salmonella spp in infant formula. Additional benefits stem from the quality factors requirements that would assure the healthy growth of infants consuming infant formula. Monetized estimates of costs and benefits for this final rule are not available at this time. The analysis for the proposed rule estimated costs of less than $1 million per year. FDA was not able to quantify benefits in the analysis for the proposed rule. Risks: Special controls for infant formula manufacturing are especially important because infant formula, particularly powdered infant formula, is an ideal medium for bacterial growth and because infants are at high risk of foodborne illness because of their immature immune systems. In addition, quality factors are of critical need to assure that the infant formula supports healthy growth in the first months of life when infant formula may be an infant's sole source of nutrition. The provisions of this rule will address weaknesses in production that may allow contamination of infant formula, including, contamination with C. sakazakii and Salmonella spp which can lead to serious illness with devastating sequelae and/or death. The provisions would also assure that new infant formulas support healthy growth in infants.
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Timetable:
Action NPRM NPRM Comment Period End NPRM Comment Period Reopened NPRM Comment Period Extended NPRM Comment Period End NPRM Comment Period Reopened NPRM Comment Period End Final Action
Unified Agenda
Date 07/09/1996 12/06/1996 04/28/2003 06/27/2003 08/26/2003 08/01/2006 09/15/2006 03/00/2012
FR Cite 61 FR 36154 68 FR 22341 68 FR 38247 71 FR 43392
Regulatory Flexibility Analysis Required: Business Government Levels Affected: No Federalism: No Energy Affected: No International Impacts: This regulatory action will be likely to have international trade and investment effects, or otherwise be of international interest. Related RINs: Split From 0910-AA04 Agency Contact: Benson Silverman Department of Health and Human Services Food and Drug Administration Center for Food Safety and Applied Nutrition (HFS-850) 5100 Paint Branch Parkway College Park , MD 20740 Phone: 240 402-1459 E-Mail: benson.silverman@fda.hhs.gov
Title: Label Requirement for Food That Has Been Refused Admission Into the United States Abstract: The final rule will require owners or consignees to label imported food that is refused entry into the United States. The label will read, "UNITED STATES: REFUSED ENTRY." The proposal describes the label's characteristics (such as its size) and processes for verifying that the label has been affixed properly. We are taking this action to prevent the introduction of unsafe food into the United States, to facilitate the examination of imported food, and to implement section 308 of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act) (Pub. L. 107-188). Priority: Other Significant Agenda Stage of Rulemaking: Final Rule Major: No Unfunded Mandates: No CFR Citation: 21 CFR 1.98 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: 15 USC 1453 to 1455; 21 USC 321; 21 USC 342 and 343; 21 USC 371; 21 USC 374; 21 USC 381; 42 USC 216; 42 USC 264 Legal Deadline: None Timetable:
Regulatory Flexibility Analysis Required: Business Government Levels Affected: Undetermined Federalism: No Energy Affected: No International Impacts: This regulatory action will be likely to have international trade and investment effects, or otherwise be of international interest. Agency Contact: Daniel Sigelman Regulatory Counsel Department of Health and Human Services Food and Drug Administration WO Building 32, Room 4254 10903 New Hampshire Avenue Silver Spring , MD 20993 52
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Title: Current Good Manufacturing Practice for Combination Products Abstract: The final rule is intended to clarify and codify the current good manufacturing practice (cGMP) requirements for combination products (combinations of a drug, device, and/or biological product). The final rule is intended to ensure consistency and appropriateness in the regulation of combination products. The final rule will provide a flexible, regulatory framework that recognizes that, in most instances, for combination products, a properly implemented quality system program under one set of medical product cGMP regulations will meet the requirements of another set (e.g., application of cGMPs for finished pharmaceuticals in 21 CFR parts 210 and 211 will generally meet the requirements of the device quality system regulations in 21 CFR part 820). It would allow manufacturers the flexibility to implement either the drug CGMP or device quality system regulation if both would apply to their manufacture of the combination product, provided that they also incorporate select, key provisions from the other set of these regulations. It would avoid the necessity to fully implement both sets of cGMP regulations when manufacturing combination products. Priority: Other Significant Agenda Stage of Rulemaking: Final Rule Unfunded Mandates: No Major: No CFR Citation: 21 CFR 4, subchapter A (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: 21 USC 321; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 360; 21 USC 360c to 360f; 21 USC 360h to 360j; 21 USC 360l; 21 USC 360hh to 360ss; 21 USC 360aaa to 360bbb; 21 USC 371a; 21 USC 372 to 374; 21 USC 379e; 21 USC 381; 21 USC 394; 42 USC 216; 42 USC 262; 42 USC 263a; 42 USC 264; 42 USC 271 Legal Deadline: None Timetable:
Action NPRM NPRM Extension of Comment Period NPRM Comment Period End Final Action Date 09/23/2009 11/10/2009 12/22/2009 05/00/2012 FR Cite 74 FR 48423 74 FR 57973
Regulatory Flexibility Analysis Required: No Government Levels Affected: State Small Entities Affected: Business Federalism: Yes Agency Contact: John Barlow Weiner Associate Director for Policy Department of Health and Human Services Food and Drug Administration Office of Combination Products W032, Room 5130 10903 New Hampshire Avenue Silver Spring , MD 20993 Phone: 301 796-8930 FAX: 301 847-8619 E-Mail: john.weiner@fda.hhs.gov
Title: Postmarket Safety Reporting for Combination Products Abstract: The rule would describe the postmarket safety reporting requirements for combination products (combinations of a drug, device, and/or biological product). The rule would provide a framework for the reporting of adverse events for combination products. The rule would clarify that a combination product is subject primarily to the reporting requirements associated with the type of marketing application under which the product is approved or cleared. In addition, the rule identifies additional reporting provisions that must be complied with if applicable. The regulation would ensure the consistency and appropriateness of postmarket safety reporting for combination products while minimizing duplicative reporting requirements.
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Priority: Other Significant Agenda Stage of Rulemaking: Final Rule Unfunded Mandates: No Major: No CFR Citation: 21 CFR 4, subchapter B (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: 21 USC 321; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 360; 21 USC 360c to 360f; 21 USC 360h to 360j; 21 USC 360l; 21 USC 360hh to 360ss; 21 USC 360aaa to 360bbb; 21 USC 371a; 21 USC 372 to 374; 21 USC 379e; 21 USC 381; 21 USC 394; 42 USC 216; 42 USC 262; 42 USC 263a; 42 USC 264; 42 USC 271 Legal Deadline: None Timetable:
Regulatory Flexibility Analysis Required: No Government Levels Affected: State Federalism: Undetermined Small Entities Affected: Business Agency Contact: John Barlow Weiner Associate Director for Policy Department of Health and Human Services Food and Drug Administration Office of Combination Products W032, Room 5130 10903 New Hampshire Avenue Silver Spring , MD 20993 Phone: 301 796-8930 FAX: 301 847-8619 E-Mail: john.weiner@fda.hhs.gov
Title: Medical Device Reporting; Electronic Submission Requirements Abstract: The Food and Drug Administration (FDA) is amending its postmarket medical device reporting (MDR) regulations to require that manufacturers, importers, and user facilities submit mandatory reports of medical device adverse events to the Agency in an electronic format that FDA can process, review, and archive. FDA is taking this action to improve the Agency's systems for collecting and analyzing postmarketing safety reports. The proposed change would help the Agency to more quickly review safety reports and identify emerging public health issues. Priority: Economically Significant Agenda Stage of Rulemaking: Final Rule Major: Yes Unfunded Mandates: No CFR Citation: 21 CFR 803 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: 21 USC 352, 360, 360i, 360j, 371, 374 Legal Deadline: None Regulatory Plan: Statement of Need: The final rule would require user facilities and medical device manufacturers and importers to submit medical device adverse event reports in electronic format instead of using a paper form. FDA is taking this action to improve its adverse event reporting program by enabling it to more quickly receive and process these reports. Legal Basis: The Agency has legal authority under section 519 of the Federal Food, Drug, and Cosmetic Act to require adverse event reports. The final rule would require manufacturers, importers, and user facilities to change their procedures to send reports of medical device adverse events to FDA in electronic format instead of using a hard copy form. Alternatives: There are two alternatives. The first alternative is to allow the voluntary submission of electronic MDRs. If a substantial number of reporters fail to voluntarily submit electronic MDRs, FDA will not obtain the benefits of standardized formats and quicker access to medical device adverse event data. The second alternative is to allow small entities more time to comply. This would significantly postpone the benefits of the rule; moreover, it would only delay, rather than reduce or eliminate, the costs of compliance. Costs and Benefits: The principal benefit would be to public health, due to the increased speed in the processing and 54
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analysis of medical device reports currently submitted annually on paper. In addition, requiring electronic submission would reduce FDA annual operating costs and generate industry savings. The one-time costs are for modifying standard operating procedures and establishing electronic submission capabilities. Annually recurring costs include maintenance of electronic submission capabilities, including renewing the electronic certificate, and for some firms, the incremental cost to maintain highspeed Internet access. Risks: None Timetable:
Regulatory Flexibility Analysis Required: No Government Levels Affected: No Federalism: No Energy Affected: No Agency Contact: Nancy Pirt Regulatory Counsel Department of Health and Human Services Food and Drug Administration Center for Devices and Radiological Health WO 66, Room 4438 10903 New Hampshire Avenue Silver Spring , MD 20993 Phone: 301 796-6248 FAX: 301 847-8145 E-Mail: nancy.pirt@fda.hhs.gov
Title: Electronic Registration and Listing for Devices Abstract: This rule would codify the requirements for electronic registration and listing. However, for those companies that do not have access to the Web, FDA will offer an avenue by which they can register, list, and update information with a paper submission. The rule also will amend part 807 to reflect the timeframes for device establishment registration and listing established by sections 222 and 223 of Food and Drug Administration Amendment Act (FDAAA) and to reflect the requirement in section 510(i) of the Act, as amended by section 321 of the Public Health Security and Bioterrorism Preparedness and Response Act (BT Act), that foreign establishments provide FDA with additional pieces of information as part of their registration. Agenda Stage of Rulemaking: Final Rule Priority: Other Significant Major: No Unfunded Mandates: No CFR Citation: 21 CFR 807 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: PL 110-85; PL 107-188, sec 321; PL 107-250, sec 207; 21 USC 360(a) through 360(j); 21 USC 360(p) Legal Deadline: None Regulatory Plan: Statement of Need: FDA is amending the medical device establishment registration and listing requirements under 21 CFR part 807 to reflect the electronic submission requirements in section 510(p) of the Act, which was added by section 207 of MDUFMA and later amended by section 224 of FDAAA. FDA also is amending 21 CFR part 807 to reflect the requirements in section 321 of the BT Act for foreign establishments to furnish additional information as part of their registration. This rule will improve FDA's device establishment registration and listing system and utilize the latest technology in the collection of this information. Legal Basis: The statutory basis for our authority includes sections 510(a) through (j), 510(p), 701, 801, and 1003 of the Act. Alternatives: The alternatives to this rulemaking include not updating the registration and listing regulations. Because of the new FDAAA statutory requirements and the advances in data collection and transmission technology, FDA believes this rulemaking is the preferable alternative. Costs and Benefits: The Agency believes that there may be some one-time costs associated with the rulemaking, which involve resource costs of familiarizing users with the electronic system. Recurring costs related to submission of the information 55
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by domestic firms would probably remain the same or decrease because a paper submission and postage is not required. There might be some increase in the financial burden on foreign firms since they will have to supply additional registration information as required by section 321 of the BT Act. Risks: None Timetable:
Action NPRM NPRM Comment Period End Final Rule Date 03/26/2010 06/24/2010 05/00/2012 FR Cite 75 FR 14510
Regulatory Flexibility Analysis Required: No Government Levels Affected: No Federalism: No Small Entities Affected: Business Energy Affected: No Agency Contact: Nancy Pirt Regulatory Counsel Department of Health and Human Services Food and Drug Administration Center for Devices and Radiological Health WO 66, Room 4438 10903 New Hampshire Avenue Silver Spring , MD 20993 Phone: 301 796-6248 FAX: 301 847-8145 E-Mail: nancy.pirt@fda.hhs.gov
Title: Exceptions or Alternatives To Labeling Requirements for Products Held by the Strategic National Stockpile Abstract: FDA issued regulations to permit FDA Center Directors to grant an exception or alternative to certain regulatory labeling provisions applicable to human drugs, biological products, or medical devices that are or will be included in the Strategic National Stockpile (SNS). Under this rule, the appropriate FDA Center Director may grant an exception or alternative to such labeling requirements if he or she determines that compliance with such requirements could adversely affect the safety, effectiveness, or availability of specified lots, batches, or other units of human drugs, biological products, or medical devices that are or will be included in the SNS, including not only those that are approved, licensed, or cleared for marketing, but also those that are investigational. A grant of an exception or alternative under these regulations will include any safeguards or conditions deemed appropriate by the FDA Center Director to ensure that the labeling of such products includes information for the safe and effective use of the products given their anticipated circumstances of use. This rule will facilitate the safety, effectiveness, and availability of appropriate medical countermeasures in the event of a public health emergency. Priority: Other Significant Agenda Stage of Rulemaking: Final Rule Unfunded Mandates: No Major: No CFR Citation: 21 CFR 201; 21 CFR 312; 21 CFR 314; 21 CFR 601; 21 CFR 610; 21 CFR 801; 21 CFR 807; 21 CFR 809; 21 CFR 812; 21 CFR 814 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: 15 USC 1451 to 1561; 21 USC 321; 21 USC 331; 21 USC 351 to 353; 21 USC 355 and 356; 21 USC 358; 21 USC 360; 21 USC 371 to 375; 21 USC 379; 21 USC 381 and 382; 21 USC 393; 42 USC 216; 42 USC 241; 42 USC 262 to 264; 42 USC 271 Legal Deadline: None Timetable:
Action Interim Final Rule Interim Final Rule Comment Period End Final Action Date 12/28/2007 03/27/2008 02/00/2012 FR Cite 72 FR 73589
Regulatory Flexibility Analysis Required: No Federalism: Yes Energy Affected: No Agency Contact: Melissa Reisman
Government Levels Affected: Federal; State
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Regulatory Counsel Department of Health and Human Services Food and Drug Administration Center for Biologics Evaluation and Research Suite 200N (HFM-17) 1401 Rockville Pike Rockville , MD 20852 Phone: 301 827-6210
Title: Postmarketing Safety Reports for Human Drug and Biological Products: Electronic Submission Requirements Abstract: The final rule would amend FDA's postmarketing safety reporting regulations for human drug and biological products (21 CFR part 310.305, 314.80, 314.98, 600.80, and 600.81) to require that safety reports submitted to the Agency by persons subject to mandatory reporting requirements be transmitted in an electronic format that FDA can process, review, and archive. FDA is taking this action to improve the Agency's systems for collecting and analyzing postmarketing safety reports. The rule will allow the Agency to review safety reports more quickly, to identify emerging safety problems, and disseminate safety information more rapidly in support of FDA's public health mission. The amendments would be a key element in harmonizing FDA's postmarketing safety reporting regulations with international and ICH standards for the electronic submission of safety information. Priority: Other Significant Agenda Stage of Rulemaking: Final Rule Unfunded Mandates: No Major: No CFR Citation: 21 CFR 310.305; 21 CFR 314.80; 21 CFR 314.98; 21 CFR 600.80 and 600.81 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: 21 USC 321; 21 USC 331; 21 USC 351 to 353; 21 USC 355 to 355a; 21 USC 356 to 356c; 21 USC 360; 21 USC 371; 21 USC 374; 21 USC 375; 21 USC 379aa; 21 USC 381; 42 USC 241; 42 USC 262; 42 USC 264; ... Legal Deadline: None Timetable:
Action ANPRM ANPRM Comment Period End NPRM NPRM Comment Period End Final Action Date 11/05/1998 02/03/1999 08/21/2009 11/19/2009 03/00/2012 74 FR 42184 FR Cite 63 FR 59746
Regulatory Flexibility Analysis Required: Undetermined Government Levels Affected: No Federalism: No Agency Contact: Reena Raman Regulatory Counsel Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research WO 51, Room 6238 10903 New Hampshire Avenue Silver Spring , MD 20993-0002 Phone: 301 796-7577 FAX: 301 847-8440 E-Mail: reena.raman@fda.hhs.gov
Title: Amendments to Sterility Testing Requirements for Biological Products Abstract: The Food and Drug Administration (FDA) is issuing a rule to amend the sterility testing requirements for biological products. This rule is intended to provide manufacturers of biological products greater flexibility and to encourage use of the most appropriate and state-of-the-art methodologies to ensure the safety of biological products.
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Priority: Other Significant Agenda Stage of Rulemaking: Final Rule Unfunded Mandates: No Major: No CFR Citation: 21 CFR 600; 21 CFR 610; 21 CFR 680 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: 21 USC 321; 21 USC 331; 21 USC 351; 21 USC 352; 21 USC 353; 21 USC 355; 21 USC 360; 21 USC 360c; 21 USC 360d; 21 USC 360h; 21 USC 360i; 21 USC 371; 21 USC 372; 21 USC 374; 21 USC 381; 42 USC 216; 42 USC 262; 42 USC 263; 42 USC 263a; 42 USC 264 Legal Deadline: None Timetable:
Regulatory Flexibility Analysis Required: No Government Levels Affected: No Federalism: No Agency Contact: Paul E. Levine Regulatory Counsel Department of Health and Human Services Food and Drug Administration Center for Biologics Evaluation and Research Suite 200N (HFM-17) 1401 Rockville Pike Rockville , MD 20852 Phone: 301 827-6210
Title: Disqualification of a Clinical Investigator Abstract: The Food and Drug Administration (FDA) is proposing to amend the regulations to expand the scope of clinical investigator disqualification. Under this proposal, when the Commissioner of Food and Drugs determines that an investigator is ineligible to receive certain investigational products such as drugs (including biologics), new animal drugs, or devices, the investigator also will be ineligible to conduct a clinical investigation that supports an application for a research or marketing permit for products regulated by the FDA. This proposal is based in part upon recommendations from the Government Accountability Office. Also, this proposal harmonizes existing FDA investigator disqualification regulations. This proposal is intended to help ensure adequate protection of research subjects and the quality and integrity of data submitted to FDA. Priority: Other Significant Agenda Stage of Rulemaking: Final Rule Major: No Unfunded Mandates: No CFR Citation: 21 CFR 16.1; 21 CFR 312.70; 21 CFR 511.1; 21 CFR 511.3 (new); 21 CFR 812.119 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: 28 USC 2112; 42 USC 201 to 262; 21 USC 321 to 394; 42 USC 263b to 263n; ... Legal Deadline: None Timetable:
Regulatory Flexibility Analysis Required: No Federalism: No Agency Contact: Kathleen E. Pfaender Senior Health Policy Analyst Department of Health and Human Services Food and Drug Administration WO32-5129 10903 New Hampshire Avenue Silver Spring , MD 20993
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Title: Food Labeling: Nutrition Labeling for Food Sold in Vending Machines Abstract: The Food and Drug Administration (FDA) published a proposed rule in the Federal Register of April 6, 2011 (72 FR 19238) to establish requirements for nutrition labeling of certain food items sold in certain vending machines. FDA also proposed the terms and conditions for vending machine operators registering to voluntarily be subject to the requirements. FDA took this action to carry out section 4205 of the Patient Protection and Affordable Care Act ("Affordable Care Act" or "ACA"), which was signed into law on March 23, 2010. Priority: Economically Significant Agenda Stage of Rulemaking: Final Rule Major: Yes Unfunded Mandates: No CFR Citation: Not Yet Determined (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: 21 USC 321; 21 USC 343; 21 USC 371 Legal Deadline: None Regulatory Plan: Statement of Need: This rulemaking was mandated by section 4205 of the Patient Protection and Affordable Care Act (Affordable Care Act). Legal Basis: On March 23, 2010, the Affordable Care Act (Pub. L. 111-148) was signed into law. Section 4205 amended 403(q)(5) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) by, among other things, creating new clause (H) to require that vending machine operators, who own or operate 20 or more machines, disclose calories for certain food items. FDA has the authority to issue this rule under sections 403(q)(5)(H) and 701(a) of the FD&C Act (21 U.S.C. 343(q)(5)(H), and 371(a)). Section 701(a) of the FD&C Act vests the Secretary of Health and Human Services, and, by delegation, the Food and Drug Administration (FDA) with the authority to issue regulations for the efficient enforcement of the FD&C Act. Alternatives: Section 4205 of the Affordable Care Act requires the Secretary (and by delegation, the FDA) to establish by regulation requirements for calorie labeling of articles of food sold from covered vending machines. Therefore, there are no alternatives to rulemaking. FDA has analyzed alternatives that may reduce the burden of the rulemaking, including analyzing the benefits and costs of: Restricting the flexibility of the format for calorie disclosure, lengthening the compliance time, and extending the coverage of the rule to bulk vending machines without selection buttons. Costs and Benefits: Any vending machine operator operating fewer than 20 machines may voluntarily choose to be covered by the national standard. It is anticipated that vending machine operators that own or operate 20 or more vending machines will bear costs associated with adding calorie information to vending machines. FDA estimates that the total cost of complying with section 4205 of the Affordable Care Act and this rulemaking will be approximately $25.8 million initially, with a recurring cost of approximately $24 million. Because comprehensive national data for the effects of vending machine labeling do not exist, FDA has not quantified the benefits associated with section 4205 of the Affordable Care Act and this rulemaking. Some studies have shown that some consumers consume fewer calories when calorie content information is displayed at the point of purchase. Consumers will benefit from having this important nutrition information to assist them in making healthier choices when consuming food away from home. Given the very high costs associated with obesity and its associated health risks, FDA estimates that if 0.02 percent of the adult obese population reduces energy intake by at least 100 calories per week, then the benefits of Section 4205 of the Affordable Care Act and this rulemaking will be at least as large as the costs. Risks: Americans now consume an estimated one-third of their total calories from foods prepared outside the home and spend almost half of their food dollars on such foods. This rule will provide consumers with information about the nutritional content of food to enable them to make healthier food choices, and may help mitigate the trend of increasing obesity in America. Timetable:
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Regulatory Flexibility Analysis Required: Business; Government Levels Affected: Federal; Local; State Governmental Jurisdictions Federalism: Yes Agency Contact: Daniel Reese Department of Health and Human Services Food and Drug Administration Center for Food Safety and Applied Nutrition (HFS-820) 5100 Paint Branch Parkway College Park , MD 20740 Phone: 240 402-2126 E-Mail: daniel.reese@fda.hhs.gov
Title: Food Labeling: Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments Abstract: The Food and Drug Administration (FDA) published a proposed rule in the Federal Register of April 6, 2011 (72 FR 19192), to establish requirements for nutrition labeling of standard menu items in chain restaurants and similar retail food establishments. FDA also proposed the terms and conditions for restaurants and similar retail food establishments registering to voluntarily be subject to the Federal requirements. FDA took this action to carry out section 4205 of the Patient Protection and Affordable Care Act ("Affordable Care Act" or "ACA"), which was signed into law on March 23, 2010. Priority: Economically Significant Agenda Stage of Rulemaking: Final Rule Major: Yes Unfunded Mandates: Private Sector CFR Citation: Not Yet Determined (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: 21 USC 321; 21 USC 343; 21 USC 371 Legal Deadline: None Regulatory Plan: Statement of Need: This rulemaking was mandated by section 4205 of the Patient Protection and Affordable Care Act (Affordable Care Act). Legal Basis: On March 23, 2010, the Affordable Care Act (Pub. L. 111-148) was signed into law. Section 4205 of the Affordable Care Act amended 403(q)(5) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) by, among other things, creating new clause (H) to require that certain chain restaurants and similar retail food establishments with 20 or more locations disclose certain nutrient information for standard menu items. FDA has the authority to issue this rule under sections 403(a)(1), 403(q)(5)(H), and 701(a) of the FD&C Act (21 U.S.C. 343(a)(1), 343(q)(5)(H), and 371(a)). Section 701(a) of the FD&C Act vests the Secretary of Health and Human Services, and, by delegation, the Food and Drug Administration (FDA) with the authority to issue regulations for the efficient enforcement of the FD&C Act. Alternatives: Section 4205 of the Affordable Care Act requires the Secretary, and by delegation the FDA, to establish by regulation requirements for nutrition labeling of standard menu items for covered restaurants and similar retail food establishments. Therefore, there are no alternatives to rulemaking. FDA has analyzed alternatives that may reduce the burden of this rulemaking, including analyzing the benefits and costs of expanding and contracting the set of establishments automatically covered by this rule and shortening or lengthening the compliance time relative to the rulemaking. Costs and Benefits: Chain restaurants and similar retail food establishments operating in local jurisdictions that impose different nutrition labeling requirements will benefit from having a uniform national standard. Any restaurant or similar retail food establishment with fewer than 20 locations may voluntarily choose to be covered by the national standard. It is anticipated that chain restaurants with 20 or more locations will bear costs for adding nutrition information to menus and menu boards. FDA estimates that the total cost of section 4205 and this rulemaking will be approximately $80 million, annualized over 10 years, with a low annualized estimate of approximately $33 million and a high annualized estimate of approximately $125 million over 10 years. These costs include an initial cost of approximately $320 million with an annually recurring cost of $45 million. Because comprehensive national data for the effects of menu labeling do not exist, FDA has not quantified the benefits associated with section 4205 of the Affordable Care Act and this rulemaking. Some studies have shown that some consumers consume fewer calories when menus have information about calorie content displayed. Consumers will benefit from having important nutrition information for the approximately 30 percent of calories consumed away from home. Given the very high costs associated with obesity and its associated health risks, FDA estimates that if 0.6 percent of the adult obese population reduces energy intake by at least 100 calories per week, then the benefits of section 4205 of the Affordable Care Act and this rule will be at least as large as the costs.
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Risks: Americans now consume an estimated one-third of their total calories on foods prepared outside the home and spend almost half of their food dollars on such foods. Unlike packaged foods that are labeled with nutrition information, foods in restaurants, for the most part, do not have nutrition information that is readily available when ordered. Dietary intake data have shown that obese Americans consume over 100 calories per meal more when eating food away from home rather than food at home. This rule will provide consumers information about the nutritional content of food to enable them to make healthier food choices and may help mitigate the trend of increasing obesity in America. Timetable:
Regulatory Flexibility Analysis Required: Business; Government Levels Affected: Federal; Local; State Governmental Jurisdictions Federalism: Yes Agency Contact: Geraldine A. June Supervisor, Product Evaluation and Labeling Team Department of Health and Human Services Food and Drug Administration Center for Food Safety and Applied Nutrition (HFS-820) 5100 Paint Branch Parkway College Park , MD 20740 Phone: 240 402-1802 FAX: 301 436-2636 E-Mail: geraldine.june@fda.hhs.gov
Title: Prior Notice of Imported Food Abstract: Public Law 111-353, section 304 amends section 801(m) (21 U.S.C. 381(m)) of the Federal Food, Drug, and Cosmetic Act to require an additional element of information be provided in a prior notice of imported food submitted to FDA. This change requires a person submitting a prior notice of imported food to the agency to report, among other things, "any country to which the article has been refused entry." Agenda Stage of Rulemaking: Final Rule Priority: Other Significant Major: No Unfunded Mandates: No CFR Citation: 21 CFR 1.281 (Revision) (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: FDA Food Safety Modernization Act, PL 111-353, sec 304 Legal Deadline:
Action Other Source Statutory Description Public Law 111 -353, sec 304 requires the Secretary to issue this interim final rule no later than 120 days following the date of enactment of PL 111 -353. Date 05/04/2011
Timetable:
Action Interim Final Rule Interim Final Rule Effective Interim Final Rule Comment Period End Final Action Date 05/05/2011 07/03/2011 08/03/2011 08/00/2012 FR Cite 76 FR 25542
Regulatory Flexibility Analysis Required: No Government Levels Affected: No Federalism: No Small Entities Affected: No Energy Affected: No International Impacts: This regulatory action will be likely to have international trade and investment effects, or otherwise be of international interest. Agency Contact: Anthony C. Taube Department of Health and Human Services Food and Drug Administration
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Office of Regulatory Affairs, Office of Regional Operations 12420 Parklawn Drive, ELEM-4051 Rockville , MD 20857 Phone: 866 521-2297 FAX: 703 261-8625 E-Mail: anthony.taube@fda.hhs.gov
Title: Administrative Detention of Food for Human or Animal Consumption Abstract: The FDA Food Safety Modernization Act (FSMA) (Pub. L. 111-353) amends the Federal Food, Drug, and Cosmetic Act (FD&C Act) with respect to the safety of the food supply. Section 207 of FSMA amends the criteria for ordering administrative detention of human or animal food in section 304(h)(1)(A) of the FD&C Act. The existing criteria allow the agency to order the detention of any article of food if during an inspection, examination, or investigation an FDA officer or qualified employee finds there is credible evidence or information indicating that the article of food presents a threat of serious adverse health consequences or death to humans or animals. Under the new criteria, FDA can order administrative detention if an FDA officer or qualified employee has reason to believe that an article of food is adulterated or misbranded. Section 207 also requires the Secretary to issue an interim final rule implementing this change no later than 120 days following the date of enactment of FSMA. The interim final rule, issued on May 5, 2011, amended the administrative detention regulations codified at 21 CFR part 1, subpart K. Priority: Substantive, Nonsignificant Agenda Stage of Rulemaking: Final Rule Unfunded Mandates: No Major: No CFR Citation: 21 CFR part 1, subpart K (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: PL 111-353, sec 207 and secs 304(h) and 701(a) of the Federal Food, Drug, and Cosmetic Act (21 USC 334(h) and 371(a)). Legal Deadline:
Action Other Source Statutory Description Interim Final Rule to amend 21 CFR part 1, subpart K within 120 days of the FDA FSMA. Date 05/04/2011
Timetable:
Action Interim Final Rule Interim Final Rule Effective Interim Final Rule Comment Period End Final Action Date 05/05/2011 07/03/2011 08/03/2011 08/00/2012 FR Cite 76 FR 25538
Regulatory Flexibility Analysis Required: Undetermined Small Entities Affected: Business Energy Affected: Undetermined Agency Contact: William A. Correll, Jr. Supervisory Consumer Safety Officer Department of Health and Human Services Food and Drug Administration 5100 Paint Branch Parkway Room 3C-019, CPK1, HFS-607 College Park , MD 20740 Phone: 240 402-1611 FAX: 301 436-2716 E-Mail: william.correll@fda.hhs.gov
Government Levels Affected: Undetermined Federalism: No
Title: Additional Safeguards for Children in Clinical Investigation of FDA-Regulated Products

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Abstract: This rule finalized the interim final rule published in 2001 to bring FDA regulations into compliance with provisions of the Children's Health Act of 2000. This rule amends FDA regulation on protection of human subjects (21 CFR Part 50) and institutional review boards (21 CFR Part 56) to provide additional safeguards for children enrolled in clinical investigation of FDA regulated trials. Compared to the interim final rule, this final rule makes minor editorial changes and a small number of substantive changes in response to comments received on the interim rule. Priority: Substantive, Nonsignificant Agenda Stage of Rulemaking: Final Rule Unfunded Mandates: No Major: No CFR Citation: 21 CFR 50; 21 CFR 56 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: 21 USC 343; 21 USC 350a; 21 USC 350b; 21 USC 352 to 353; 21 USC 355; 21 USC 360j; 21 USC 371; 42 USC 262 Legal Deadline: None Timetable:
Action Interim Final Rule Final Action Date 04/24/2001 04/00/2012 FR Cite 66 FR 20589
Regulatory Flexibility Analysis Required: No Government Levels Affected: Federal Small Entities Affected: No Federalism: No Agency Contact: Rorbert "Skip" Nelson Department of Health and Human Services Food and Drug Administration WO 32, Room 5126 10903 New Hampshire Avenue Silver Spring , MD 20993 Phone: 301 796-8665 E-Mail: robert.nelson@fda.hhs.gov
Title: Food Labeling; Gluten-Free Labeling of Foods Abstract: Title II of Public Law 108-282 (sec. 206) directed the HHS Secretary to issue a proposed rule by 08/04/2006, and a final rule by 08/04/2008, to define and permit use of the term "gluten-free" in the labeling of foods. The purpose of this rulemaking is to assist persons who have celiac disease to more easily identify foods that they can eat following a "gluten-free" diet. Celiac disease is a genetically inherited chronic inflammatory disorder of the small intestine triggered by ingesting certain storage proteins, commonly referred to as "gluten," that naturally occur in wheat, rye, barely, and crossbred hybrids of these grains (e.g., triticale). Eating foods containing gluten can cause damage to the lining of the small intestine. With continual exposure to gluten, the damage to the small intestine can result in the malabsorption of nutrients, resulting in nutritional deficiencies. Persons with celiac disease are also at higher risk of developing other serious disease health problems and diseases (e.g., growth retardation, short stature, infertility, and intestinal cancers). About 1 percent of the U.S. population is estimated to have celiac disease. FDA issued a proposed rule on gluten-free food labeling on 01/23/07 (72 FR 2795), that proposed to define the "gluten-free," for voluntary use in the labeling of foods, to mean that the food does not contain: (1) An ingredient that is a species of certain prohibited grains; (2) an ingredient derived from those prohibited grains and that has not been processed to remove gluten; (3) an ingredient derived from those prohibited grains and that has been processed to remove gluten, if the use of that ingredient results in the presence of 20 parts per million (ppm) or more gluten in the food; or (4) 20 ppm or more gluten. The term "prohibited grains" refers to wheat, rye, barley, and crossbred hybrids of these grains (e.g., triticale, which is a cross between wheat and rye). FDA also announced in the proposed rule that we intended to conduct a safety assessment for gluten exposure and seek comments on the safety assessment and its potential use in defining the term "gluten-free" in the final rule. On 08/03/11 (76 FR 46671), FDA reopened the comment period on the proposed rule to announce the availability of and seek comments on the completed, expert-reviewed safety assessment. FDA is also seeking comments on whether and, if so, how the safety assessment should affect FDA's definition of "gluten-free" in the final rule, as well as on other related issues. Priority: Other Significant Agenda Stage of Rulemaking: Final Rule Major: Undetermined Unfunded Mandates: No CFR Citation: 21 CFR 101.91 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: title II of PL 108-282; 21 USC 321; 21 USC 331; 21 USC 342; 21 USC 343; 21 USC 348; 21 USC 371 Legal Deadline:
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Action NPRM Source Statutory

Description Publication of NPRM 01/23/2007
Unified Agenda
Date 08/04/2006
Timetable:
Action NPRM NPRM Comment Period End NPRM Comment Period Reopened NPRM Reopened Comment Period End Final Action Date 01/23/2007 04/23/2007 08/03/2011 10/03/2011 11/00/2012 76 FR 46671 FR Cite 72 FR 2795
Regulatory Flexibility Analysis Required: No Government Levels Affected: No Federalism: No Small Entities Affected: No Energy Affected: No International Impacts: This regulatory action will be likely to have international trade and investment effects, or otherwise be of international interest. Agency Contact: Rhonda Rhoda Kane Consumer Safety Officer Department of Health and Human Services Food and Drug Administration Center for Food Safety and Applied Nutrition 5100 Paint Branch Parkway Room 4D008, HFS-820 College Park , MD 20740 Phone: 240 402-1803 FAX: 301 436-2636 E-Mail: rhonda.kane@fda.hhs.gov
Title: Food Labeling; Revision of the Nutrition and Supplement Facts Labels Abstract: In the Federal Register of July 11, 2003 (68 FR 41507), FDA published an ANPRM (the 2003 ANPRM) to solicit information and data on trans fat labeling and claims made about trans fats. Comments received to the 2003 ANPRM that pertain to the labeling of trans fat will be addressed in this proposed rule. In addition, the Agency published an ANPRM on the prominence of calories on the food label on April 4, 2005 (the 2005 ANPRM) (70 FR 17008), and an ANPRM on the revision of reference values and mandatory nutrients on November 2, 2007 (the 2007 ANPRM) (72 FR 62149). The Agency also intends to address the comments received to the 2005 and 2007 ANPRM's in this proposed rule. FDA is proposing to amend labeling regulations for conventional foods and dietary supplements to provide updated nutrition information on the label to assist consumers in maintaining healthy dietary practices. Mandatory nutrition labeling of food was first required in 1993. Much of the information found on the Nutrition Facts label has not been updated since that time. If finalized, this rule will modernize the nutrition information found on the Nutrition Facts label, as well as the format and appearance of the label. Among the changes proposed, the Agency intends to: 1) Provide updated Daily Reference values (DRVs) and Reference Daily Intake values (RDIs) that are based on the latest scientific evidence from consensus reports, such as the Institute of Medicine Dietary Reference Intakes; 2) provide DRVs and RDIs, as well as requirements for foods purported to be for children under 4 years of age and pregnant or lactating women; and 3) make changes to the mandatory declaration of specific nutrients. The Agency is also considering revisions to the format and appearance of the Nutrition Facts label and the Supplement Facts label, including the prominence of calories on the label. Priority: Economically Significant Agenda Stage of Rulemaking: Long-term Action Major: Yes Unfunded Mandates: Undetermined CFR Citation: 21 CFR 101.9; 21 CFR 101.36 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: 21 USC 321; 21 USC 343; 21 USC 371 Legal Deadline: None Timetable:
Action ANPRM ANPRM Comment Period End ANPRM ANPRM Comment Period End Date 07/11/2003 10/09/2003 04/04/2005 06/20/2005 70 FR 17008 FR Cite 68 FR 41507
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ANPRM ANPRM Comment Period End NPRM

11/02/2007 01/31/2008 12/00/2012 72 FR 62149
Unified Agenda
Regulatory Flexibility Analysis Required: Business; Government Levels Affected: Federal; Local Governmental Jurisdictions Federalism: Yes Energy Affected: No International Impacts: This regulatory action will be likely to have international trade and investment effects, or otherwise be of international interest. Agency Contact: Blakeley Fitzpatrick Interdisciplinary Scientist Department of Health and Human Services Food and Drug Administration Center for Food Safety and Applied Nutrition (HFS-830) HFS-830 5100 Paint Branch Parkway College Park , MD 20740 Phone: 240 402-1450 E-Mail: blakeley.fitzpatrick@fda.hhs.gov
Title: Over-the-Counter (OTC) Drug Review--Oral Health Care Products Abstract: The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safe and effective and not misbranded. After a final monograph (i.e., final rule) is issued, only OTC drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. The NPRM and final action will address oral health care products used to reduce or prevent dental plaque and gingivitis. Priority: Routine and Frequent Agenda Stage of Rulemaking: Long-term Action Major: No Unfunded Mandates: No CFR Citation: 21 CFR 201; 21 CFR 310; 21 CFR 330 to 358 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 360 to 360a; 21 USC 371 to 371a Legal Deadline: None Timetable:
Action NPRM (Benzocaine) ANPRM (Plaque Gingivitis) ANPRM Comment Period End Date 00/00/0000 05/29/2003 08/27/2003 68 FR 32232 FR Cite
Regulatory Flexibility Analysis Required: Business Government Levels Affected: Local; State Federalism: Yes Related RINs: Split From 0910-AA01 Agency Contact: David Eng Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research WO 22, Room 5487 10903 New Hampshire Avenue Silver Spring , MD 20993 Phone: 301 796-2773 FAX: 301 796-9899 E-Mail: david.eng@fda.hhs.gov

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Title: Use of Materials Derived From Cattle in Human Food and Cosmetics Abstract: On July 14, 2004, FDA issued an interim final rule (IFR), effective immediately, to prohibit the use of certain cattle material and to address the potential risk of bovine spongiform encephalopathy (BSE) in human food, including dietary supplements, and cosmetics. FDA amended the IFR in 2005 and 2008. Prohibited cattle materials under the IFR as amended include specified risk materials, small intestine of all cattle, material from nonambulatory disabled cattle, material from cattle not inspected and passed for human consumption, and mechanically separated (MS) beef. Specified risk materials are the brain, skull, eyes, trigeminal ganglia, spinal cord, vertebral column (excluding the vertebrae of the tail, the transverse processes of the thoracic and lumbar vertebrae, and the wings of the sacrum), and dorsal root ganglia of cattle 30 months and older; and the tonsils and distal ileum of the small intestine of all cattle. Prohibited cattle materials do not include tallow that contains no more than 0.15 percent hexane-insoluble impurities and tallow derivatives, hides and hide derived products, and milk and milk products. This action minimizes human exposure to materials that scientific studies have demonstrated are highly likely to contain the BSE agent in cattle infected with the disease. Scientists believe that the human disease variant Creutzfeldt-Jakob disease (vCJD) is likely caused by the consumption of products contaminated with the agent that causes BSE. FDA has become aware of new literature which indicates that portions of the small intestine besides the distal ileum may harbor the prions causative of BSE. FDA believes that it should obtain comments from the public on the significance of these new reports and is reopening the comment period for this regulation. Priority: Other Significant Agenda Stage of Rulemaking: Long-term Action Unfunded Mandates: No Major: No CFR Citation: 21 CFR 189.5; 21 CFR 700.27 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: 21 USC 342; 21 USC 361; 21 USC 371 Legal Deadline: None Timetable:
Action Final Action Interim Final Rule Effective Interim Final Rule Interim Final Rule Comment Period End Interim Final Rule (Amendments) Interim Final Rule (Amendments) Effective Interim Final Rule (Amendments) Comment Period End Interim Final Rule (Amendments) Interim Final Rule (Amendments) Effective Interim Final Rule (Amendments) Comment Period End Date 00/00/0000 07/14/2004 07/14/2004 10/12/2004 09/07/2005 10/07/2005 11/07/2005 04/17/2008 07/16/2008 07/16/2008 73 FR 20785 70 FR 53063 69 FR 42256 FR Cite
Regulatory Flexibility Analysis Required: No Government Levels Affected: No Federalism: No Energy Affected: No International Impacts: This regulatory action will be likely to have international trade and investment effects, or otherwise be of international interest. Agency Contact: Amber McCoig Consumer Safety Officer Department of Health and Human Services Food and Drug Administration Center for Food Safety and Applied Nutrition (HFS-316) 5100 Paint Branch Parkway College Park , MD 20740 Phone: 240 402-2131 FAX: 301 436-2644 E-Mail: amber.mccoig@fda.hhs.gov
Title: Pet Food Labeling Requirements Abstract: The President signed into law the Food and Drug Administration Amendments Act of 2007 (FDAAA) on September 27, 2007 (Pub. L. 110-85). Title X of the FDAAA includes several provisions pertaining to food safety, including the safety of pet food. Section 1002(a)(3) of the new law directs FDA to issue new regulations to establish updated standards for the labeling of pet food that include nutritional and ingredient information. This same provision of the law also directs that, in developing these 66
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new regulations, FDA consult with the Association of American Feed Control Officials and other relevant stakeholder groups, including veterinary medical associations, animal health organizations, and pet food manufacturers. Priority: Other Significant Agenda Stage of Rulemaking: Long-term Action Major: No Unfunded Mandates: No CFR Citation: Not Yet Determined (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: 21 USC 343; 21 USC 371; PL 110-85, sec 1002(a)(3) Legal Deadline:
Action Other Source Statutory Description Date 09/27/2009
Timetable:
Regulatory Flexibility Analysis Required: Business Government Levels Affected: State Federalism: Yes Energy Affected: No International Impacts: This regulatory action will be likely to have international trade and investment effects, or otherwise be of international interest. Agency Contact: William Burkholder Veterinary Medical Officer Department of Health and Human Services Food and Drug Administration Center for Veterinary Medicine Room 2642 (MPN-4, HFV-228) 7519 Standish Place Rockville , MD 20855 Phone: 240 453-6865 E-Mail: william.burkholder@fda.hhs.gov
Title: Animal Drugs, Feeds, and Related Products; Regulation of Carcinogenic Compounds in Food-Producing Animals Abstract: The Food and Drug Administration (FDA) plans to publish a final rule to amend regulations regarding food additives, color additives, and animal drugs of carcinogenic concern used in food-producing animals. No food additive, color additive, or animal drug can be deemed safe if it is found to induce cancer in man or animals. An exception can be made for animal drugs and additives used in food producing animals if it can be found that: (1) An animal feed additive, color additive, or animal drug will not adversely affect the animal, and (2) no residue of the animal feed additive, color additive, or animal drug will be found in any edible portion of that animal when residues are measured according to an approved regulatory method. FDA regulations impose requirements for the sensitivity of the approved regulatory method for testing residues of carcinogenic compounds in edible animal tissues. The regulatory method must be sensitive enough to detect levels of carcinogenic compound that corresponds to the level of the compound that may be consumed daily by the human consumer with no significant increase in the risk of cancer. The sensitivity is calculated by determining the concentration of residue of carcinogenic concern in the total diet that can safely be consumed by humans over a lifetime. This concentration is termed the So. The So is currently defined by regulation primarily as the concentration of the carcinogenic compound that corresponds to a maximum lifetime risk to test animals of 1 in 1 million, and secondarily as corresponding to the concentration of residue of carcinogenic concern in the total human diet that represents no significant increase in the risk of cancer to people. FDA believes that a careful reading of the December 31, 1987, final rule (52 FR 49586) suggests that an emphasis on no significant increase in the risk of cancer to the human consumer, rather than on the specific 1 in 1 million approach, reflects the original intent of the regulation. Specifically, FDA is proposing a revision to the definition of So for clarification purposes so that the term primarily means the concentration of residue of carcinogenic concern in the total human diet that represents no significant increase in the risk of cancer to the human consumer and secondarily corresponds to the concentration of test compound in the total diet of test animals that corresponds to a maximum lifetime risk of cancer in the test animals of 1 in 1 million. These changes reflect advances in scientific technology. Other clarifying and conforming changes are also being proposed. Priority: Substantive, Nonsignificant Agenda Stage of Rulemaking: Long-term Action Major: No Unfunded Mandates: No CFR Citation: 21 CFR 500.82 and 500.84 (To search for a specific CFR, visit the Code of Federal Regulations )
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Legal Authority: 21 USC 348(c)(3)(A); 21 USC 360b(d)(1)(I); 21 USC 371(a); 21 USC 379e(b)(5)(B) Legal Deadline: None Timetable:
Action Final Action NPRM NPRM Comment Period End Date 00/00/0000 12/20/2010 03/07/2011 75 FR 79320 FR Cite
Regulatory Flexibility Analysis Required: No Government Levels Affected: No Federalism: No Agency Contact: Kevin Greenlees Senior Science Advisor Department of Health and Human Services Food and Drug Administration Center for Veterinary Medicine Room 238B (MPN-1, HFV-100) 7520 Standish Place Rockville , MD 20855 Phone: 240 276-8214 FAX: 240 276-8118 E-Mail: kevin.greenlees@fda.hhs.gov
Title: Food Labeling; Dietary Guidance Statements Abstract: This proposed rule would define dietary guidance statements as statements in food labeling about the usefulness of a foods, or a category of foods, in maintaining healthy dietary practices. Dietary guidance statements focus on general dietary patterns, practices, and recommendations that promote health. They may highlight the presence or amount of a food or category of foods in relation to a general health benefit or healthful diet or recommend the substitution of a food or food category that is consistent with current dietary recommendations for a food or food category that is less beneficial to health. The proposed rule would also establish requirements for making dietary guidance statements in food labeling. In addition, the proposed rule provides guidance on how dietary guidance statements differ from other types of food labeling claims. Priority: Other Significant Agenda Stage of Rulemaking: Long-term Action Major: No Unfunded Mandates: Undetermined CFR Citation: 21 CFR 101.16 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: 21 USC 321 and 331; 21 USC 343 and 371 Legal Deadline: None Timetable:
Regulatory Flexibility Analysis Required: Undetermined Government Levels Affected: Undetermined Federalism: No Agency Contact: Blakeley Fitzpatrick Interdisciplinary Scientist Department of Health and Human Services Food and Drug Administration Center for Food Safety and Applied Nutrition (HFS-830) HFS-830 5100 Paint Branch Parkway College Park , MD 20740 Phone: 240 402-1450 E-Mail: blakeley.fitzpatrick@fda.hhs.gov
Department of Health and Human Services (HHS)

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Food and Drug Administration ( FDA )
Unified Agenda
Title: Further Amendments to General Regulations of the Food and Drug Administration to Incorporate Tobacco Products Abstract: The Food and Drug Administration is seeking to amend certain of its general regulations to include tobacco products, where appropriate, in light of FDA's authority to regulate these products under the Family Smoking Prevention and Tobacco Control Act. The final rule will cover revisions to the document reporting requirements and definition of "product." Priority: Other Significant Agenda Stage of Rulemaking: Long-term Action Unfunded Mandates: No Major: No CFR Citation: Not Yet Determined (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: 21 USC 321; 21 USC 331; 21 USC 333; 21 USC 371; 21 USC 381; 21 USC 387; 21 USC 387a; 21 USC 387c; 21 USC 387f; 21 USC 387k; 15 USC 1333; 15 USC 4402 Legal Deadline: None Timetable:
Regulatory Flexibility Analysis Required: Business Federalism: No Agency Contact: Gerie Voss Regulatory Counsel Department of Health and Human Services Food and Drug Administration 9200 Corporate Boulevard Rockville , MD 20850 Phone: 877 287-1373 FAX: 240 276-4193 E-Mail: gerie.voss@fda.hhs.gov
Title: Food Labeling: Hard Candies and Breath Mints Abstract: The Food and Drug Administration is proposing to amend certain provisions of its serving size regulations to change the label serving size for breath mints to one unit. This action is in response to an advanced notice of proposed rulemaking published in 2005, in which FDA requested comment on whether to amend certain provisions of its nutrition labeling regulations concerning serving size and a 1997 proposed rule entitled Food Labeling: Hard Candies and Breath Mints (62 FR 67775). Agenda Stage of Rulemaking: Long-term Action Priority: Substantive, Nonsignificant Major: No Unfunded Mandates: Undetermined CFR Citation: 21 CFR 101.9; 21 CFR 101.12 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: 21 USC 321; 21 USC 343; 21 USC 371 Legal Deadline: None Timetable:
Action NPRM NPRM Comment Period End ANPRM ANPRM Comment Period End NPRM Date 12/30/1997 03/16/1998 04/05/2005 06/20/2005 12/00/2012 70 FR 17010 FR Cite 62 FR 67775
Regulatory Flexibility Analysis Required: Business

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Federalism: Yes Energy Affected: No International Impacts: This regulatory action will be likely to have international trade and investment effects, or otherwise be of international interest. Agency Contact: Mark Kantor Nutritionist Department of Health and Human Services Food and Drug Administration 5100 Paint Branch Parkway HFS-830 College Park , MD 20740 Phone: 240 402-1450 FAX: 301 436-1191 E-Mail: mark.kantor@fda.hhs.gov
Title: Food Labeling; Serving Sizes; Reference Amounts for Candies Abstract: The Food and Drug Administration is proposing to amend certain provisions of its serving size regulations to provide updated Reference Amounts Customarily Consumed for candies. This action is in response to an advance notice of proposed rulemaking published in 2005, in which FDA requested comment on whether to amend certain provisions of its nutrition labeling regulations concerning serving size and a 1998 proposed rule entitled "Food Labeling: Reference Amounts for Candies" (63 FR 1078). Priority: Substantive, Nonsignificant Agenda Stage of Rulemaking: Long-term Action Major: No Unfunded Mandates: Undetermined CFR Citation: 21 CFR 101.9; 21 CFR 101.12 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: 21 USC 321; 21 USC 343; 21 USC 371 Legal Deadline: None Timetable:
Action NPRM NPRM Comment Period End ANPRM ANPRM Comment Period End NPRM Date 01/08/1998 02/09/1998 04/05/2005 06/20/2005 12/00/2012 70 FR 17010 FR Cite 63 FR 1078
Regulatory Flexibility Analysis Required: Business Federalism: Yes Energy Affected: No Agency Contact: Mark Kantor Nutritionist Department of Health and Human Services Food and Drug Administration 5100 Paint Branch Parkway HFS-830 College Park , MD 20740 Phone: 240 402-1450 FAX: 301 436-1191 E-Mail: mark.kantor@fda.hhs.gov
Title: Tobacco Product Standard

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Abstract: Section 907 of the Federal Food, Drug, and Cosmetic Act, as amended by the Family Smoking Prevention and Tobacco Control Act, authorizes FDA to issue tobacco product standards that the agency finds are appropriate for the protection of the public health. FDA intends to develop one or more tobacco product standards to reduce the harms and/or addictiveness of tobacco products or that is otherwise appropriate for the protection of the public health. Priority: Other Significant Agenda Stage of Rulemaking: Long-term Action Major: Undetermined Unfunded Mandates: Undetermined CFR Citation: Not Yet Determined (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: PL 111-31, The Family Smoking Prevention and Tobacco Control Act, section 907 Legal Deadline: None Timetable:
Regulatory Flexibility Analysis Required: Undetermined Small Entities Affected: Business Energy Affected: No Agency Contact: Annette L. Marthaler Regulatory Counsel Department of Health and Human Services Food and Drug Administration 9200 Corporate Boulevard, Room 340K Rockville , MD 20850 Phone: 877 287-1373 FAX: 240 276-3904 E-Mail: annette.marthaler@fda.hhs.gov
Government Levels Affected: Undetermined Federalism: Undetermined
Title: Blood Initiative--Requirements for Human Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use Abstract: The Food and Drug Administration (FDA) is amending the biologics regulations, particularly those related to blood donor eligibility, by removing, revising, or updating specific regulations applicable to blood, blood components, Source Plasma, and Source Leukocytes to be more consistent with current practices and to remove unnecessary or outdated requirements. This action is based on FDA's comprehensive review of the biologics regulations. It is also responsive to reports by the U.S. House of Representatives Committee on Government Reform and Oversight Subcommittee on House Resources and Intergovernmental Relations, the Government Accountability Office (previously, the General Accounting Office), and the Institute of Medicine, and to public comments. These actions are intended to help ensure the continued safety of the Nation's blood supply. Priority: Other Significant Agenda Stage of Rulemaking: Long-term Action Major: Undetermined Unfunded Mandates: No CFR Citation: 21 CFR 606; 21 CFR 610; 21 CFR 630; 21 CFR 640; 21 CFR 660; 21 CFR 820; 21 CFR 1270 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: 21 USC 321; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 360; 21 USC 360c to 360e; 21 USC 360h to 360j; 21 USC 360l; 21 USC 371; 21 USC 372; 21 USC 374; 21 USC 381; 21 USC 383; 42 USC 216; 42 USC 243; 42 USC 262 and 263; 42 USC 263a; 42 USC 264; 42 USC 271 Legal Deadline: None Timetable:
Action NPRM NPRM Comment Period Extended NPRM Comment Period End NPRM Comment Period Extended End Final Action Date 11/08/2007 01/11/2008 02/06/2008 08/04/2008 12/00/2012 FR Cite 72 FR 63416 73 FR 1983
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Regulatory Flexibility Analysis Required: No Government Levels Affected: No Federalism: No Small Entities Affected: Business Energy Affected: No Agency Contact: Valerie A. Butler Team Leader Department of Health and Human Services Food and Drug Administration Center for Biologics Evaluation and Research Suite 200N (HFM-17) 1401 Rockville Pike Rockville , MD 20852 Phone: 301 827-6210 FAX: 301 827-3093 E-Mail: valerie.butler@fda.hhs.gov
RIN: 0910-AC25 View Related Documents
Title: Medical Devices; Exception From General Requirements for Informed Consent Abstract: This rule affirmed the interim final rule's exception from the general requirement for informed consent in certain circumstances involving the use of investigational in vitro diagnostic devices to identify chemical, biological, radiological, or nuclear agents in a potential terrorist event or other public health emergency. Informed consent will be required unless the clinical investigator determines in writing that: 1) There exists a life-threatening situation involving the human subject of such testing which necessitates the use of the investigational device; 2) it is not feasible to obtain informed consent from the subject; and 3) there is not sufficient time to obtain such consent from his or her representative. Further, a licensed physician uninvolved in the testing must agree in writing with this three-part determination before the product is used unless immediate use of the device is required to save the life of the human subject of such testing and there is not sufficient time to get such concurrence. This final rule adds a requirement that the investigator submit this required documentation to FDA, in addition to submitting the documentation to the Institutional Review Board (IRB). Priority: Other Significant Agenda Stage of Rulemaking: Completed Action Unfunded Mandates: No Major: No CFR Citation: 21 CFR 50.23 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: 21 USC 321; 21 USC 343; 21 USC 346 to 346a; 21 USC 348; 21 USC 350a; 21 USC 352; 21 USC 353; 21 USC 355; 21 USC 360; 21 USC 360c to 360f; 21 USC 360h to 360j; 21 USC 371; 21 USC 379e; 21 USC 381; 42 USC 216; 42 USC 241; 42 USC 262; 42 USC 263b to 263n Legal Deadline: None Timetable:
Action Interim Final Rule Interim Final Rule Comment Period End Final Action Date 06/07/2006 08/07/2006 06/24/2011 76 FR 36989 FR Cite 71 FR 32827
Regulatory Flexibility Analysis Required: No Government Levels Affected: State Small Entities Affected: No Federalism: No Agency Contact: Claudia M. Gaffey Medical Officer Department of Health and Human Services Food and Drug Administration Center for Devices and Radiological Health WO66, Room 5516 10903 New Hampshire Avenue Silver Spring , MD 20993 Phone: 301 796-6196 FAX: 301 847-8144 E-Mail: claudia.gaffey@fda.hhs.gov
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View Related Documents Title: Over-the-Counter (OTC) Drug Review--Cough/Cold (Bronchodilator) Products Abstract: The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safe and effective and not misbranded. After a final monograph (i.e., final rule) is issued, only OTC drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. This action addresses labeling for single ingredient bronchodilator products. Agenda Stage of Rulemaking: Completed Action Priority: Substantive, Nonsignificant Major: No Unfunded Mandates: No CFR Citation: 21 CFR 201; 21 CFR 310; 21 CFR 330 to 358 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 360; 21 USC 371 Legal Deadline: None Timetable:
Action NPRM (Amendment--Ephedrine Single Ingredient) NPRM Comment Period End Final Action (Technical Amendment) Final Action (Amendment--Single Ingredient Labeling) Date 07/13/2005 11/10/2005 11/30/2007 07/26/2011 72 FR 67639 76 FR 44475 FR Cite 70 FR 40237
Regulatory Flexibility Analysis Required: Business Government Levels Affected: Local; State Federalism: Yes Related RINs: Split From 0910-AA01 Agency Contact: Mary Chung Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research WO 22, Room 5488 10903 New Hampshire Avenue Silver Spring , MD 20993 Phone: 301 796-0260 FAX: 301 796-9899 E-Mail: mary.chung@fda.hhs.gov
Title: Over-the-Counter (OTC) Drug Review--Poison Treatment Drug Products Abstract: The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safe and effective and not misbranded. After a final monograph (i.e., final rule) is issued, only OTC drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. This action addresses the ingredient ipecac syrup. Agenda Stage of Rulemaking: Completed Action Priority: Substantive, Nonsignificant Major: No Unfunded Mandates: No CFR Citation: 21 CFR 201; 21 CFR 310; 21 CFR 330 to 358 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 360; 21 USC 371 Legal Deadline: None Timetable:
Action Withdrawn Date 09/08/2011 FR Cite
Regulatory Flexibility Analysis Required: Business Government Levels Affected: Local; State Federalism: Yes Agency Contact: David Eng Department of Health and Human Services Food and Drug Administration
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Center for Drug Evaluation and Research WO 22, Room 5487 10903 New Hampshire Avenue Silver Spring , MD 20993 Phone: 301 796-2773 FAX: 301 796-9899 E-Mail: david.eng@fda.hhs.gov
Title: Animal Food Labeling; Declaration of Certifiable Color Additives Abstract: The Food and Drug Administration (FDA) is amending its regulations regarding the declaration of certified color additives on the labels of animal food including animal feeds and pet foods. FDA is proposing this amendment in response to the Nutrition Labeling and Education Act of 1990 (PL 101-535), which amended section 403 of the Federal Food, Drug, and Cosmetic Act (21 USC 343) by requiring, among other things, the listing on food labels of the common or usual names of all color additives required to be certified by FDA. An additional purpose of this amendment is to make these regulations consistent with the regulations regarding the declaration of certified color additives on the labels of human food. The final rule also suggests appropriate terminology for the declaration of certification-exempt color additives on the labels of animal food. Priority: Substantive, Nonsignificant Agenda Stage of Rulemaking: Completed Action Major: No Unfunded Mandates: No CFR Citation: 21 CFR 501.22(k) (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: 21 USC 343(i) Legal Deadline: None Timetable:
Regulatory Flexibility Analysis Required: No Government Levels Affected: No Federalism: No International Impacts: This regulatory action will be likely to have international trade and investment effects, or otherwise be of international interest. Agency Contact: John P. Machado Veterinary Medical Officer Department of Health and Human Services Food and Drug Administration Center for Veterinary Medicine Room 2640 (MPN-4, HFV-228) 7519 Standish Place Rockville , MD 20855 Phone: 240 453-6854 FAX: 240 453-6882 E-Mail: john.machado@fda.hhs.gov
Title: Tobacco Product Substantial Equivalence Exemptions Abstract: This rule implements the substantial equivalence exemption provision of the Family Smoking Prevention and Tobacco Control Act. The Secretary may exempt from the requirements relating to demonstration that a tobacco product is substantially equivalent, tobacco products that are modified by adding or deleting a tobacco additive or increasing or decreasing the quantity of an existing tobacco additive, if the Secretary determines the modification would be a minor modification of a tobacco product that can be sold under the law, a report is not necessary to ensure that permitting the tobacco product to be marketed would be appropriate for protection of the public health, and an exemption is otherwise appropriate.
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Priority: Other Significant Agenda Stage of Rulemaking: Completed Action Major: No Unfunded Mandates: No CFR Citation: 21 CFR 1107.1 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: 21 USC 371; 21 USC 387e; 21 USC 387j Legal Deadline:
Timetable:
Regulatory Flexibility Analysis Required: No Federalism: No Agency Contact: Annette L. Marthaler Regulatory Counsel Department of Health and Human Services Food and Drug Administration 9200 Corporate Boulevard, Room 340K Rockville , MD 20850 Phone: 877 287-1373 FAX: 240 276-3904 E-Mail: annette.marthaler@fda.hhs.gov
Title: Cigarette Warning Label Statements Abstract: Section 4 of the FCLAA, as amended by section 201 of the Tobacco Control Act, requires FDA to issue regulations that require color graphics depicting the negative health consequences of smoking to accompany required warning statements on cigarette packages and advertisements. FDA also may adjust the type size, text and format of the required label statements on product packaging and advertising if FDA determines that it is appropriate so that both the graphics and the accompanying label statements are clear, conspicuous, legible and appear within the specified area. Priority: Economically Significant Agenda Stage of Rulemaking: Completed Action Major: Yes Unfunded Mandates: Private Sector CFR Citation: 21 CFR 1141 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: PL 111-31, The Family Smoking Prevention and Tobacco Control Act, sec 201 Legal Deadline: Section 4 of the Federal Cigarette Labeling and Advertising Act (FCLAA), as amended by section 201 of the Family Smoking Prevention and Tobacco Control Act (the Tobacco Control Act), requires FDA to issue regulations no later than 24 months after the date of enactment of the Tobacco Control Act that require color graphics depicting the negative health consequences of smoking to appear on cigarette packages and advertisements.
Timetable:
Regulatory Flexibility Analysis Required: Business Government Levels Affected: No Federalism: No Energy Affected: No International Impacts: This regulatory action will be likely to have international trade and investment effects, or otherwise be of
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international interest. Agency Contact: Gerie Voss Regulatory Counsel Department of Health and Human Services Food and Drug Administration 9200 Corporate Boulevard Rockville , MD 20850 Phone: 877 287-1373 FAX: 240 276-4193 E-Mail: gerie.voss@fda.hhs.gov
Unified Agenda
Title: Effective Date of Requirement for Premarket Approval for Three Class III Preamendments Devices Abstract: The purpose of this rule required the submission of a premarket approval application or notice of completion of a product development protocol for three class III preamendments devices. This regulation will provide FDA with more oversight concerning the three class III device types that currently can be marketed via less stringent premarket notification procedures. If finalized, this regulation will require premarket approval for the three class III device types within 90 days of the issuance of a final rule or within 30 months after final classification of the device, whichever is later. The three devices are ventricular bypass (assist) device; pacemaker repair or replacement material; and female condom. The rule also publicizes advisory panel findings on the three device types and provides an opportunity to request a change in classification of the devices based on new information. Priority: Substantive, Nonsignificant Agenda Stage of Rulemaking: Completed Action Unfunded Mandates: No Major: No CFR Citation: 21 CFR 870; 21 CFR 884 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: 21 USC 360e; 21 USC 371(a) Legal Deadline: None Timetable:
Regulatory Flexibility Analysis Required: No Government Levels Affected: No Federalism: No Energy Affected: No Agency Contact: Nancy Pirt Regulatory Counsel Department of Health and Human Services Food and Drug Administration Center for Devices and Radiological Health WO 66, Room 4438 10903 New Hampshire Avenue Silver Spring , MD 20993 Phone: 301 796-6248 FAX: 301 847-8145 E-Mail: nancy.pirt@fda.hhs.gov
Department of Health and Human Services (HHS) Indian Health Service ( IHS )
Title: Standards for the Planning, Design, Construction and Operation of Health Care and Sanitation Facilities Abstract: Section 311(c)(1) of the Indian Health Care Improvement Act, Public Law No. 94-437 (1976), as amended by the Patient Protection and Affordable Care Act, Public Law No. 111-148, section 10221 (2010) requires the Secretary, acting though
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the Indian Health Service (IHS), to establish, by regulation, standards for the planning, design, construction, and operation of health care and sanitation facilities serving Indians under the Indian Health Care Improvement Act. Additionally, these regulations would stipulate which departmental regulations would be applicable to these activities. Priority: Other Significant Agenda Stage of Rulemaking: Proposed Rule Unfunded Mandates: Undetermined Major: Undetermined CFR Citation: Not Yet Determined (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: PL 94-437, sec 311(c)(1); IHCI Act as amended by PL 111-148, sec 10221 Legal Deadline: None Timetable:
Regulatory Flexibility Analysis Required: Undetermined Federalism: No Agency Contact: Ronald C. Ferguson Director, Division of Sanitation Facilities Construction Department of Health and Human Services Indian Health Service 801 Thompson Avenue, TMP 610 Rockville , MD 20852 Phone: 301 443-1046 E-Mail: rferguso@hqe.ihs.gov
Title: Confidentiality of Medical Quality Assurance Records; Qualified Immunity for Participants Abstract: Section 805(j)) of the Indian Health Care Improvement Act, Public Law No. 94-437 (1976), as amended by the Patient Protection and Affordable Care Act, Public Law No. 111-148, section 10221 (2010) requires the Secretary of the Department of Health and Human Services, acting through the Indian Health Service (IHS), to promulgate regulations to implement section 805. Section 805 makes confidential and privileged the medical quality assurance records of Indian health programs and urban Indian organizations, with very limited exceptions. It also prohibits the testimony of individuals that review or create medical quality assurance records, with very limited exceptions. Although section 805 is immediately executable, the Secretary is required to issue regulations which could substantively affect the implementation of this provision. Priority: Other Significant Agenda Stage of Rulemaking: Proposed Rule Major: No Unfunded Mandates: No CFR Citation: Not Yet Determined (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: PL 94-437, sec 805, IHCI ACT; amended by PL 111-148; sec 10221 Legal Deadline: None Timetable:
Regulatory Flexibility Analysis Required: No Federalism: No Energy Affected: No Agency Contact: Paul Fowler IHS Risk Management Officer Department of Health and Human Services Indian Health Service 801 Thompson Avenue Suite 331 Rockville , MD 20852 Phone: 301 443-6372 FAX: 301 594-6213
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Title: Catastrophic Health Emergency Fund (CHEF) Abstract: Section 202(d) of the Indian Health Care Improvement Act (IHCIA), Public Law No. 94-437 (1976), as amended by the Patient Protection and Affordable Care Act, Public Law No. 111-148, section 10221 (2010) requires the Secretary of the Department of Health and Human Services, acting through the Indian Health Service (IHS), to promulgate regulations to implement section 202. Section 202 of the IHCIA amends the IHS Catastrophic Health Emergency Fund (CHEF) to revise the threshold cost for reimbursement of the cost of treatment using contract health services funds to an IHS or Tribally managed facility. The law also describes an annual increase in the threshold that is based on the increase in the medical care expenditure category of the consumer price index for all consumers for the 12 month period ending with December of the previous year. Priority: Other Significant Agenda Stage of Rulemaking: Proposed Rule Major: Undetermined Unfunded Mandates: No CFR Citation: Not Yet Determined (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: PL 94-437, sec 202(d), IHCI Act, as amended by PL 111-148, sec 10221 Legal Deadline: None Timetable:
Regulatory Flexibility Analysis Required: Undetermined Federalism: No Energy Affected: No Agency Contact: Carl Harper Director, Office of Resource Access and Partnerships Department of Health and Human Services Indian Health Service 801 Thompson Avenue TMP Suite 360 Rockville , MD 20852 Phone: 301 443-1016 E-Mail: carl.harper@hhs.gov
Department of Health and Human Services (HHS) Centers for Disease Control and Prevention ( CDC )
Title: Amendments to Specifications for Medical Examinations of Underground Coal Miners Abstract: NIOSH plans to modify sections of 42 CFR part 37 to allow for the use of digital radiography in medical screening of coal miners for coal workers' pneumoconiosis. Current provisions of these regulations require the use of film radiography which is being phased out of use at medical facilities in the United States. Priority: Other Significant Agenda Stage of Rulemaking: Proposed Rule Major: No Unfunded Mandates: No CFR Citation: 42 CFR 37 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: 30 USC 843 Legal Deadline: None Timetable:
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Regulatory Flexibility Analysis Required: No Federalism: No Agency Contact: David Weissman Director, Division of Respiratory Disease Studies Department of Health and Human Services Centers for Disease Control and Prevention 1095 Willowdale Road MS G900 Morgantown , WV 26505 Phone: 304 285-5749 E-Mail: dweissman@cdc.gov

Government Levels Affected: Federal
Unified Agenda
Title: Inward Leakage Requirements for Respirators Abstract: NIOSH plans to re-issue this NPRM in response to public comment. The proposed rule will improve certification requirements for half-mask air-purifying particulate respirators and establish performance requirements for an alternate class of half-mask air-purifying respirators to prevent inward leakage of contaminants through the face seal and evaluate non-filter components. The rule would supplement existing requirements for testing the performance of the filter and thus provide manufacturers greater flexibility in their applications. Priority: Other Significant Agenda Stage of Rulemaking: Proposed Rule Major: No Unfunded Mandates: No CFR Citation: 42 CFR 84 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: 29 USC 651 et seq; 29 USC 657(g); 30 USC 3; 30 USC 7; 30 USC 811; 30 USC 842(h) and 844 Legal Deadline: None Timetable:
Action NPRM NPRM Comment Period End NPRM Comment Period Reopened NPRM Public Meeting NPRM Comment Period End NPRM Date 10/30/2009 12/29/2009 04/20/2010 07/29/2010 09/30/2010 05/00/2012 75 FR 20546 75 FR 29699 FR Cite 74 FR 66935
Regulatory Flexibility Analysis Required: No Small Entities Affected: No Energy Affected: No Agency Contact: William E. Newcomb Physical Scientist Department of Health and Human Services Centers for Disease Control and Prevention PO Box 18070 626 Cochrans Mill Road Pittsburgh , PA 15236 Phone: 412 386-5200 E-Mail: wnewcomb@cdc.gov
Title: Public Health Security and Bioterrorism Preparedness and Response Act of 2002; Biennial Review and Republication of the Select Agent and Toxin List Abstract: The Bioterrorism Preparedness Act requires that the HHS Secretary review and republish the list of select agents and toxins on at least a biennial basis. To assist with the biennial review, HHS reviewed recommendations provided by subject 79
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matter experts and the Intragovernmental Select Agents and Toxins Advisory Committee. In addition, on July 2, 2010, the President signed "Executive Order 13546: Optimizing the Security of Biological Select Agents and Toxins in the United States" to review, tier, and reduce the Select Agent List; establishing personal reliability standards for BSAT workers; and establishing physical security standards for identified Tier 1 select agents and toxins. This final rule implements the Executive Order and updates the list of select agents and toxins. Priority: Other Significant Agenda Stage of Rulemaking: Proposed Rule Unfunded Mandates: No Major: No CFR Citation: None (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: PL 107-188; 42 USC 262(a) Legal Deadline: None Timetable:
Action NPRM NPRM Comment Period End NPRM Comment Period Reopened NPRM Comment Period Reopened End Final Action Date 10/03/2011 12/02/2011 12/16/2011 01/17/2012 10/00/2012 76 FR 78215 FR Cite 76 FR 61206
Regulatory Flexibility Analysis Required: No Small Entities Affected: No Energy Affected: No Agency Contact: Robbin Weyant Director, Division of Select Agents and Toxins Department of Health and Human Services Centers for Disease Control and Prevention MS A-46 Clifton Road NE. Atlanta , GA 30333 Phone: 404 718-2000 E-Mail: rweyant@cdc.gov
Title: Control of Communicable Diseases: Foreign and Possessions; Proposed Revision of CDC Etiological Agents Importation Regulations Abstract: By statute, CDC implements regulations found at 42 CFR 71.54 restricting the importation and transportation of etiologic agents. Importers are required to complete an application for permit. Under its current regulatory framework, policies and procedures, the EAIPP does not perform on-site inspections at these facilities prior to the issuance of an import permit. Permits are issued based on a review of safety information provided by a potential importer in support of an import permit application. Rule-making is needed with the aim of improving CDC's ability to prevent importation of communicable diseases into the United States. CDC is considering whether to adopt a program similar to the U.S. Department of Agriculture/Animal and Plant Health Inspection Service Program such as conducting inspections on importer facilities prior to issuance of a permit for etiologic agents such as Mycobacterium tuberculosis and Hantavirus, providing an appeal process for denied applications. Priority: Other Significant Agenda Stage of Rulemaking: Proposed Rule Major: No Unfunded Mandates: No CFR Citation: 42 CFR 71.54 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: PHA as amended (42 USC 216, 264 to 272) Legal Deadline: None Timetable:
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Regulatory Flexibility Analysis Required: No Small Entities Affected: No Energy Affected: No Agency Contact: Robbin Weyant Director, Division of Select Agents and Toxins Department of Health and Human Services Centers for Disease Control and Prevention MS A-46 Clifton Road NE. Atlanta , GA 30333 Phone: 404 718-2000 E-Mail: rweyant@cdc.gov

Unified Agenda
Title: Open-Circuit Self-Contained Breathing Apparatus End-of-Service-Time Indicator Performance Requirements Abstract: The end-of-service-time indicators are devices built into respirators to alert the users that the oxygen provided to the user is close to depletion. This rule responds to a petition to allow the indicators to be set to better match the different worker protection needs to different work operations. Priority: Other Significant Agenda Stage of Rulemaking: Proposed Rule Major: No Unfunded Mandates: No CFR Citation: 42 CFR 84.83(f) (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: 29 USC 651 et seq; 30 USC 3 and 5; 30 USC 7; 30 USC 842(h) and 30 USC 844; 30 USC 957 Legal Deadline: None Timetable:
Regulatory Flexibility Analysis Required: No Federalism: No Energy Affected: No Agency Contact: Jon Szalajda Chief, Policy and Standards Branch Department of Health and Human Services Centers for Disease Control and Prevention 626 Cochrans Mill Road Pittsburgh , PA 15236 Phone: 412 386-5200 E-Mail: jszalajda@cdc.gov
Title: Amendments to Respirator Certification Fees Abstract: NIOSH approves respirators used in a variety of industrial settings; regulations governing approval are codified in 42 CFR part 84. The fees charged to respirator manufacturers for approval of their products have not changed since 1972; the current approval fees cover less than 10 percent of the costs of generating certificates. Updating these fees will allow NIOSH's respirator certification program to recover the costs associated with the approval process. Agenda Stage of Rulemaking: Proposed Rule Priority: Other Significant Major: No Unfunded Mandates: No CFR Citation: 42 CFR 84.20 to 84.22 (To search for a specific CFR, visit the Code of Federal Regulations )
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Legal Authority: 29 USC 651 et seq; 30 USC 3 and 5; 30 USC 7; 30 USC 842(h) and 844; 30 USC 957 Legal Deadline: None Timetable:
Regulatory Flexibility Analysis Required: No Small Entities Affected: No Energy Affected: No Agency Contact: David Book Physical Scientist Department of Health and Human Services Centers for Disease Control and Prevention 626 Cochrans Mill Rd Pittsburgh , PA 15236 Phone: 412 386-6691 E-Mail: dbook@cdc.gov
Title: Establishment of Minimum Standards for Birth Certificates Abstract: Section 7211 of the Intelligence Reform and Terrorism Prevention Act (IRTPA) mandates that HHS establish, by regulation, minimum standards to improve the security of birth certificates for use by Federal agencies for official purposes. Priority: Other Significant Agenda Stage of Rulemaking: Proposed Rule Unfunded Mandates: State, Local, Or Tribal Governments Major: No CFR Citation: Not Yet Determined (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: 42 USC 264 Legal Deadline:
Timetable:
Regulatory Flexibility Analysis Required: Governmental Jurisdictions Federalism: Yes Energy Affected: No Agency Contact: Charles Rothwell Director, Division of Vital Statistics Department of Health and Human Services Centers for Disease Control and Prevention 3311 Toledo Road Room 7311, M Hyattsville , MD 20782 Phone: 301 458-4555
Government Levels Affected: Federal; Local; State
Title: Establishment of User Fees for Filovirus Testing of Nonhuman Primate Liver Samples 82
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Abstract: HHS/CDC requires Filovirus testing of all nonhuman primates that die for any reason other than trauma during the 31 day quarantine period. Through this Direct Final Rule, HHS is publishing a Notice of Proposed Rulemaking concurrently. U.S. Quarantine Veterinary officers will be instructed on how to transfer tissue specimens to CDC, complying with Department of Transportation and International Air Transport Association regulations. Testing will be conducted by CDC laboratories. This regulation will establish user fees that will be effective immediately. Priority: Other Significant Agenda Stage of Rulemaking: Proposed Rule Unfunded Mandates: No Major: No CFR Citation: 42 CFR 71.53 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: 42 USC 264 Legal Deadline: None Timetable:
Action NPRM/Direct Final Rule Date 02/00/2012 FR Cite
Regulatory Flexibility Analysis Required: No Federalism: No Energy Affected: No Agency Contact: Ashley Marrone Public Health Analyst Department of Health and Human Services Centers for Disease Control and Prevention MS-E03 1600 Clifton Road NE. Atlanta , GA 30329 Phone: 404 498-1600 E-Mail: amarrone@cdc.gov
Title: Approval Tests and Standards for Closed-Circuit Escape Respirators Abstract: This rule updates performance testing and other specifications for the certification of closed-circuit self-contained escape breathing apparatus. These respiratory protective devices are used in emergencies for the protection of miners and workers in other industries. Priority: Other Significant Agenda Stage of Rulemaking: Final Rule Major: No Unfunded Mandates: No CFR Citation: 42 CFR 84 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: 29 USC 651 et seq; 30 USC 3; 30 USC 5; 30 USC 7; 30 USC 811; 30 USC 842; 30 USC 844 Legal Deadline: None Timetable:
Action NPRM NPRM Comment Period End NPRM Comment Period Reopened NPRM Comment Period End NPRM Comment Period Reopened NPRM Comment Period End Final Action Date 12/10/2008 02/09/2009 03/04/2009 04/10/2009 05/21/2009 06/19/2009 02/00/2012 74 FR 23814 74 FR 9380 FR Cite 73 FR 75027
Regulatory Flexibility Analysis Required: No Small Entities Affected: No Energy Affected: No Agency Contact: Tim Rehak General Engineer
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Department of Health and Human Services Centers for Disease Control and Prevention 626 Cochran Mill Road Pittsburgh , PA 15236 Phone: 412 386-5200 FAX: 412 386-4089 E-Mail: trehak@cdc.gov
Unified Agenda
Title: Control of Communicable Diseases: Foreign and Possessions Regulations; Nonhuman Primate Abstract: In this final rule, CDC will amend its regulations related to the importation of live nonhuman primates (NHPs) by extending existing requirements for the importation of cynomolgus, African green, and rhesus monkeys to all NHPs. CDC will also reduce the frequency at which importers of the three species are required to renew their registrations, (from every 180 days to every two years) and incorporate existing guidelines into regulations. CDC will add new provisions to address NHPs imported as part of a circus or trained animal act, NHPs imported by zoological societies, the transfer of NHPs from approved laboratories, and non-live imported NHP products. Finally, all NHPs will be imported only through ports of entry where a CDC quarantine station is located. Priority: Substantive, Nonsignificant Agenda Stage of Rulemaking: Final Rule Major: No Unfunded Mandates: No CFR Citation: 42 CFR 71.53 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: 42 USC 264 Legal Deadline: None Timetable:
Action NPRM NPRM Comment Period End NPRM Comment Period Extended NPRM Comment Period Extended End Final Action Date 01/05/2011 03/07/2011 03/10/2011 04/25/2011 07/00/2012 76 FR 13120 FR Cite 76 FR 678
Regulatory Flexibility Analysis Required: No Federalism: No Agency Contact: Ashley Marrone Public Health Analyst Department of Health and Human Services Centers for Disease Control and Prevention MS-E03 1600 Clifton Road NE. Atlanta , GA 30329 Phone: 404 498-1600 E-Mail: amarrone@cdc.gov
Title: Guidelines for Determining the Probability of Causation Under the Energy Employees Occupational Illness Compensation Program Act of 2000; Revision of Guidelines for Non-Radiogenic Cancers Abstract: The Department of Health and Human Services (HHS) will treat chronic lymphocytic leukemia (CLL) as a radiogenic cancer under the Energy Employees Occupational Illness Compensation Program Act of 2000 (EEOICPA). CLL has been considered to be caused by radiation and hence not potentially compensable under EEOICPA. HHS reverses its decision to exclude CLL from such treatment.
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Priority: Other Significant Agenda Stage of Rulemaking: Final Rule Major: No Unfunded Mandates: No CFR Citation: 42 CFR 81.30 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: 42 USC 7384n; EO 13179 Legal Deadline: None Timetable:
Action NPRM NPRM Comment Period Extended NPRM Comment Period End NPRM Comment Period Extended End Final Action Date 03/21/2011 06/23/2011 06/20/2011 07/20/2011 01/00/2012 FR Cite 76 FR 15268 76 FR 36891
Regulatory Flexibility Analysis Required: No Federalism: No Energy Affected: No Agency Contact: Stuart Hinnefeld Director, Division of Compensation Analysis and Support Department of Health and Human Services Centers for Disease Control and Prevention 4676 Columbia Parkway, MS-C46 Cincinnati , OH 45226 Phone: 513 533-6800 E-Mail: ocas@cdc.gov
Title: World Trade Center Health Program Requirements for Enrollment, Appeals, Certification of Health Conditions, and Reimbursement Abstract: These regulations implement portions of the WTC Health Program established within the Department of Health and Human Services. The WTC Health Program, which will be administered in part by the Director of NIOSH at CDC, will provide medical monitoring and treatment to firefighters and other eligible responders who responded to the September 11, 2001, terrorist attacks in New York City, Shanksville, PA, and at the Pentagon, and to eligible survivors of the New York City attacks. The final rule establishes the processes by which eligible responders and survivors may apply for enrollment in the WTC Health Program, obtain health monitoring and treatment for WTC-related health conditions, and appeal enrollment and treatment decisions. The final rule also establishes reimbursement rates for providers who provide initial health evaluations, treatment, and health monitoring. Priority: Economically Significant Agenda Stage of Rulemaking: Final Rule Major: Yes Unfunded Mandates: No CFR Citation: 42 CFR 88 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: PL 111-347 Legal Deadline:
Timetable:
Regulatory Flexibility Analysis Required: No Small Entities Affected: No Energy Affected: No
Government Levels Affected: Federal Federalism: No

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Agency Contact: Roy Fleming Senior Science Advisor, World Trade Center Health Program Department of Health and Human Services Centers for Disease Control and Prevention 1600 Clifton Road NE MS-E74 Atlanta , GA 30329 Phone: 866 426-3673 E-Mail: wtcpublicinput@cdc.gov
Title: World Trade Center Health Program Requirements for the Addition of New WTC-Related Health Conditions Abstract: This rule establishes the processes by which the WTC Program Administrator may add a new condition to the list of WTC-related health conditions through rulemaking; and includes a process for considering petitions by interested parties to add a new condition. Priority: Other Significant Agenda Stage of Rulemaking: Final Rule Major: No Unfunded Mandates: No CFR Citation: 42 CFR 88 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: PL 111-347 Legal Deadline: None Timetable:
Regulatory Flexibility Analysis Required: No Small Entities Affected: No Energy Affected: No Agency Contact: Roy Fleming Senior Science Advisor, World Trade Center Health Program Department of Health and Human Services Centers for Disease Control and Prevention 1600 Clifton Road NE MS-E74 Atlanta , GA 30329 Phone: 866 426-3673 E-Mail: wtcpublicinput@cdc.gov
Title: Control of Communicable Diseases: Foreign Abstract: The final rule focuses primarily on requirements relating to the reporting of deaths and illnesses onboard aircrafts and ships traveling from foreign countries into the United States, and the collection of specific traveler contact information for the purpose of CDC contacting travelers in the event of an exposure to a communicable disease. Priority: Economically Significant Agenda Stage of Rulemaking: Long-term Action Unfunded Mandates: Private Sector Major: Yes CFR Citation: 42 CFR 71 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: 42 USC 243; 42 USC 264 and 265; 42 USC 267 and 268; 42 USC 270 and 271 Legal Deadline:
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Action Other Source Statutory

Description
Unified Agenda
Date 06/00/2009
Timetable:
Regulatory Flexibility Analysis Required: Business; Governmental Jurisdictions Federalism: No Energy Affected: No Agency Contact: Ashley Marrone Public Health Analyst Department of Health and Human Services Centers for Disease Control and Prevention MS-E03 1600 Clifton Road NE. Atlanta , GA 30329 Phone: 404 498-1600 E-Mail: amarrone@cdc.gov
Title: Control of Communicable Diseases: Interstate Abstract: This rule focuses primarily on requirements relating to the reporting of deaths and illnesses onboard aircrafts traveling domestically, and the collection of specific traveler contact information for the purpose of CDC contacting travelers in the event of an exposure to a communicable disease. Priority: Economically Significant Agenda Stage of Rulemaking: Long-term Action Major: Yes Unfunded Mandates: Private Sector CFR Citation: 42 CFR 70 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: 28 USC 198; 28 USC 231; 25 USC 1661; 42 USC 243; 42 USC 248 and 249; 42 USC 264; 42 USC 266 to 268; 42 USC 270 to 272; 42 USC 2001 Legal Deadline:
Timetable:
Regulatory Flexibility Analysis Required: Business; Governmental Jurisdictions Federalism: No Energy Affected: No Agency Contact: Ashley Marrone Public Health Analyst Department of Health and Human Services Centers for Disease Control and Prevention MS-E03 1600 Clifton Road NE. Atlanta , GA 30329 Phone: 404 498-1600 E-Mail: amarrone@cdc.gov
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Title: Amendments To Establish Wildland Firefighting Protection Performance Requirements for Approval of Respiratory Protective Devices Abstract: NIOSH has determined this rulemaking is not required to develop a class of respirator. The National Fire Protection Association (NFPA) has developed NFPA 1984: Standard on Respirators for Wildland Fire Fighting Operations, 2011 Edition, as a national consensus standard. NIOSH participated in the committee that developed the standard, and NIOSH can certify, under current requirements of 42 CFR 84, for the NFPA identified performance requirements and protections in the new NFPA1984. Priority: Other Significant Agenda Stage of Rulemaking: Completed Action Unfunded Mandates: No Major: No CFR Citation: 42 CFR 84 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: 29 USC 651 et seq; 30 USC 3 and 5; 30 USC 7; 30 USC 811 and 842(h); 30 USC 844; 30 USC 957; ... Legal Deadline: None Timetable:
Regulatory Flexibility Analysis Required: No Federalism: No Energy Affected: No Agency Contact: Tim Rehak General Engineer Department of Health and Human Services Centers for Disease Control and Prevention 626 Cochran Mill Road Pittsburgh , PA 15236 Phone: 412 386-5200 FAX: 412 386-4089 E-Mail: trehak@cdc.gov
Department of Health and Human Services (HHS) National Institutes of Health ( NIH )
Title: National Institutes of Health Loan Repayment Programs Abstract: NIH proposes to issue a single set of regulations to govern all of its loan repayment (LRP) authorities. This action will include rescinding the current regulations at 42 CFR part 68a and at 42 CFR part 68c replaced by the new consolidated set of LRP regulations. Establishing a single set of regulations to govern all eight of the current NIH loan repayment programs rather than issuing a separate set of regulations for each program will serve to streamline regulatory requirements for the programs and enhance program participants' understanding of and compliance with program requirements. Priority: Substantive, Nonsignificant Agenda Stage of Rulemaking: Proposed Rule Major: No Unfunded Mandates: No CFR Citation: 42 CFR 68 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: 42 USC 216; 42 USC 288-5a; 42 USC 287c-33; 42 USC 288-1; 42 USC 288-3; 42 USC 288-5 and 288-6 Legal Deadline: None Timetable:

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Small Entities Affected: No Energy Affected: No Agency Contact: Jerry Moore NIH Regulations Officer Department of Health and Human Services National Institutes of Health 6011 Executive Boulevard Rockville , MD 20852 Phone: 301 496-4606 FAX: 301 402-0169 E-Mail: jm40z@nih.gov

Federalism: No
Unified Agenda
Title: Undergraduate Scholarship Program Regarding Professions Needed by the National Institutes of Health Abstract: Section 487D of the Public Health Service Act, as added by NIH Revitalization Act of 1993, creates a program offering scholarships to individuals from disadvantaged backgrounds who are enrolled as full-time students at accredited institutions pursuing academic programs appropriate for careers in professions needed by NIH. For each year of scholarship support, the recipient agrees to provide service (employment) after graduation, at NIH, for 1 year. Additionally, the individual agrees to provide at least 10 consecutive weeks of service (employment) at NIH during which the individual is attending the educational institution and receiving the NIH scholarship. The proposed new regulations will govern this program. Agenda Stage of Rulemaking: Proposed Rule Priority: Substantive, Nonsignificant Major: No Unfunded Mandates: No CFR Citation: 42 CFR 68b (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: 42 USC 216; 42 USC 288-4 Legal Deadline: None Timetable:
Regulatory Flexibility Analysis Required: No Small Entities Affected: No Energy Affected: No Agency Contact: Jerry Moore NIH Regulations Officer Department of Health and Human Services National Institutes of Health 6011 Executive Boulevard Rockville , MD 20852 Phone: 301 496-4606 FAX: 301 402-0169 E-Mail: jm40z@nih.gov
Title: Expanded Registration and Results Reporting at ClinicalTrials.gov Abstract: The National Institutes of Health (NIH) proposes to issue new regulations that will prescribe procedures for registering and reporting the results, including adverse events, of clinical trials in ClinicalTrials.gov, in accordance with section 801 of the Food and Drug Administration Amendments Act of 2007, (FDAAA, PL. 110-85). As previously announced, the agency intends to proceed with a single rulemaking to implement the expanded registry, results reporting, and adverse event information reporting requirements of the statute. The rulemaking will also consider topics that the statute requires to be 89
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addressed in regulations intended [to provide more complete results information and to enhance patient access to and understanding of the results of clinical trials] [as codified in 42 U.S.C. 282(j)(3)(D)], including whether results information should be required to be submitted for applicable clinical trials of drugs, biological products, or devices that have not been approved, licensed, or cleared by the Food and Drug Administration, and whether narrative summaries of clinical trials and their results can be included in the data bank without being misleading or promotional. These topics were the subject of discussion at the public meeting organized by NIH in April 2009, and of written public comments. The regulations will identify the trials that are subject to the registration and results reporting requirements (including adverse event reporting); the specific information and format of the information that must be submitted to ClinicalTrials.gov; deadlines for registering and reporting results; procedures for extending the deadlines or waiving the submission requirements; and procedures for agency review and public posting of submitted information. Priority: Other Significant Agenda Stage of Rulemaking: Proposed Rule Unfunded Mandates: No Major: No CFR Citation: 42 CFR 3 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: 42 USC282(i); 42 USC 282(j); 5 USC 301; 42 USC 286(a); 42 USC 241(a); 42 USC 216(b) Legal Deadline:
Timetable:
Regulatory Flexibility Analysis Required: Undetermined Small Entities Affected: Business Energy Affected: No Agency Contact: Jerry Moore NIH Regulations Officer Department of Health and Human Services National Institutes of Health 6011 Executive Boulevard Rockville , MD 20852 Phone: 301 496-4606 FAX: 301 402-0169 E-Mail: jm40z@nih.gov
Title: Privacy Act Regulation Concerning NIH Records Related to Research Misconduct Proceedings Abstract: The Department of Health and Human Services (HHS), through the National Institutes of Health (NIH), is implementing a new system of records, 09-25-0223, "NIH Records Related to Misconduct Proceedings, HHS/NIH." HHS would exempt this system of records from certain requirements of the Privacy Act, to protect records compiled in the course of NIH research-mission proceedings, and to protect the identity of confidential course in such proceedings. HHS is issuing direct final rule for this action because the agency expects that there will be no significant adverse comment on this rule. HHS is also publishing a companion proposed rule under the agency's usual procedures for notice-and-comment rulemaking, to provide a procedural framework to finalize the rule in the event the agency receives any significant comments and withdraws the direct final rule. The companion proposed rule and direct final rule will be substantively identical. Priority: Substantive, Nonsignificant Agenda Stage of Rulemaking: Final Rule Unfunded Mandates: No Major: No CFR Citation: 45 CFR 5b (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: 5 USC 301; 5 USC 552a Legal Deadline: None Timetable:
Action Final Action Date 03/00/2012 FR Cite
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Government Levels Affected: Undetermined Federalism: No
Title: Endowment Program Abstract: The Director of the National Institute on Minority Health and Health Disparities is authorized under section 485E(h)(1) of the Public Health Service Act to carry out a program to facilitate minority health disparities research and other health disparities research by providing for research endowments centers of excellence under section 736 (Public Health Service Act). NIH plans to issue implementing regulations to govern these research endowments. Agenda Stage of Rulemaking: Completed Action Priority: Other Significant Major: No Unfunded Mandates: No CFR Citation: 42 CFR 52i (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: 42 USC 216; 42 USC 287c-31 Legal Deadline: None Timetable:
Title: NIH Training Grants Abstract: NIH plans to amend the Agency's existing training grants regulations to: (1) Reflect their applicability to the training authorities set forth in sections 464W and 485F of the Public Health Service Act; (2) reflect their applicability to training programs of the National Institute on Minority Health and Health Disparities (NIMHD) and Fogarty International Center (FIC) awards; and (3) reflect their applicability for grants that the National Institute of Nursing Research (NINR) makes to nonprofit institutions to provide training and instruction in the study and investigation of the prevention of disease, health promotion, and 91
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the nursing care of individuals with, and the families of individuals with acute and chronic illnesses. Priority: Substantive, Nonsignificant Agenda Stage of Rulemaking: Completed Action Unfunded Mandates: No Major: No CFR Citation: 42 CFR 63a (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: 42 USC 216; 42 USC 2421; 42 USC 285q-1; 42 USC 287c-31 and 287c-32 Legal Deadline: None Timetable:
Title: Amendment of Regulation of the Responsibility of Applicants for Promoting Objectivity in Research for Which PHS Funding Is Sought and Responsible Prospective Contractors Abstract: The Department of Health and Human Services is issuing a final rule to amend the final rule to amend the Public Health Service(PHS) regulations on the Responsibility of Applicants for Promoting Objectivity in Research for Which PHS funding is Sought and Responsible Prospective Contractors. Since the promulgation of the regulations in 1995, biomedical and behavioral interactions among government research institutions and the private sector have become increasingly complex. This complexity, as well as a need to strengthen accountability, have led to the need for amendments to expand and add transparency to investigator disclosure of significant financial interests, enhance regulatory compliance and effective institutional oversight and management of investigators' financial conflicts of interst, as well as the agency's ability to ensure compliance." Priority: Other Significant Agenda Stage of Rulemaking: Completed Action Unfunded Mandates: No Major: No CFR Citation: 45 CFR 50, subpart F; 45 CFR 94 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: 42 USC 216; 42 USC 289b-1; 42 USC 299c-4; sec 219, title II, Div D, PL 111-117, 123 Stat 3034 Legal Deadline: None Timetable:
Action ANPRM ANPRM Comment Period End NPRM NPRM Comment Period End Final Action Date 05/08/2009 07/07/2009 05/21/2010 08/19/2010 08/25/2011 75 FR 28688 75 FR 42362 76 FR 53256 FR Cite 74 FR 21610
Regulatory Flexibility Analysis Required: No Small Entities Affected: Business Energy Affected: No Agency Contact: Jerry Moore NIH Regulations Officer
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Department of Health and Human Services National Institutes of Health 6011 Executive Boulevard Room 601, MSC 7669 Rockville , MD 20852 Phone: 301 496-4607 FAX: 301 402-0169 E-Mail: jm40z@nih.gov
Unified Agenda
Title: National Institutes of Health Construction Grants Abstract: The National Institutes of Health (NIH) proposes to review and/or amend the existing regulations at 42 CFR 52b governing grants awarded by the agency and its components for construction of new buildings and the alteration, renovation, remodeling, improvement, expansion, and repair of existing buildings, including the provision of equipment necessary to make the building (or applicable part of the building) suitable for which it was constructed. The NIH proposes to revise and/or amend the regulations to promote consistency with the Department of Health and Human Services (HHS) regulations at 45 CFR 74 applicable to recovery and insurance coverage. Specifically, NIH proposes to replace language in section 52b.9(a)(1) with the language in 45 CFR 74.32(c)(2), and replace the language in section 52b.10(n) with the language in 45 CFR 74.31. The narrative in section 52b.12(b) that refers to the National Cancer Institute having copies of certain resource documents would be updated. Citations in section 52b.12(c) design and construction standards would be updated. Section 52b.14(c) would be amended to reference Executive Order 12372, Intergovernmental Review of Federal Programs. Reference numbers (1), (3), (4), (5), (6), and (7) in section 53b.14(d) Policies would be updated. Priority: Substantive, Nonsignificant Agenda Stage of Rulemaking: Completed Action Unfunded Mandates: No Major: Undetermined CFR Citation: 42 CFR 52b (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: 42 USC 216; 42 USC 285a-2 and 285a-3; 42 USC 285b-3 and 285b-4; 42 USC 285d-6 and 285i; 42 USC 285m-3 and 285o-4; 42 USC 287a-2 and 287a-3; 42 USC 300cc-41 Legal Deadline: None Timetable:
Department of Health and Human Services (HHS) Substance Abuse and Mental Health Services Administration ( SAMHSA )
Title: Opioid Drugs in Maintenance or Detoxification Treatment of Opiate Addiction Abstract: This rule would amend the Federal opioid treatment program regulations. It would modify the dispensing requirements for buprenorphine and buprenorphine combination products that are approved by the Food and Drug Administration (FDA) for opioid dependence and used in federally certified and registered opioid treatment programs.
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Priority: Other Significant Agenda Stage of Rulemaking: Final Rule Unfunded Mandates: No Major: No CFR Citation: 42 CFR 8 to 12 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: 21 USC 823 (9); 42 USC 257a; 42 USC 290aa(d); 42 USC 290dd-2; 42 USC 300xx-23; 42 USC 300x-27(a); 42 USC 300y-11 Legal Deadline: None Timetable:
Regulatory Flexibility Analysis Required: No Government Levels Affected: No Federalism: No Small Entities Affected: No Energy Affected: No Agency Contact: Nicholas Reuter Department of Health and Human Services Substance Abuse and Mental Health Services Administration Suite 2-1063 One Choke Cherry Road Rockville , MD 20857 Phone: 240 276-2716 E-Mail: nicholas.reuter@samhsa.hhs.gov
Title: Protection and Advocacy for Individuals With Mental Illness Abstract: A final rule implementing the requirements of the Protection and Advocacy with Mental Illness Act was published on October 15, 1997 (Federal Register, Vol. 62, No. 193, page 53548). This proposed rule clarifies some of the requirements from that rule and implements changes made to the statute in the Children's Health Act of 2000 (Pub. L. 106-310, section 3206). Most notably Public Law 106-310 extended the authority of the protection and advocacy (P&A) systems authorized in the legislation to provide representation to individuals living in a community setting, including their own home if the total allotment under the program for any fiscal year was $30 million or more. Prior to the passage of Public Law 106-310, the P&A systems could only represent individuals living in inpatient or residential institutions. The allotment for the P&A program has been above $30 million since fiscal year 2000. Priority: Substantive, Nonsignificant Agenda Stage of Rulemaking: Completed Action Unfunded Mandates: No Major: Undetermined CFR Citation: 42 CFR 51 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: Protection and Advocacy with Mental Illness Act; 42 USC 10801 Legal Deadline: None Timetable:
Regulatory Flexibility Analysis Required: No Small Entities Affected: No Energy Affected: No Agency Contact: Joseph Denis Faha Director, DLEA, SAMHSA Department of Health and Human Services Substance Abuse and Mental Health Services Administration 5600 Fishers Lane Rockville , MD 20857 Phone: 301 443-7017 FAX: 301 443-1450
Government Levels Affected: No Federalism: Undetermined
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E-Mail: jfaha@samhsa.gov
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Title: Community Mental Health Services and Substance Abuse Prevention and Treatment Block Grants Abstract: Sections 1911 through 1956 of the Public Health Service Act authorize the Community Mental Health Services (CMHS) Block Grant and the Substance Abuse Prevention and Treatment (SAPT) Block Grant. Regulations establishing the criteria that the Secretary would use in approving applications for the CMHS Block Grant have never been issued. Regulations establishing the criteria for the SAPT Block Grant, except for implementation of section 1926 related to tobacco, were issued on March 31, 1993, in compliance with section 1932(d). The regulations with regard to section 1926 were issued on January 19, 1996. The rule will establish criteria for approving applications for the CMHS Block Grant for the first time, and update the regulations for the SAPT to reflect changes in statute and our experience over the past seventeen years. The regulations will emphasize consistent and effective planning, reporting and expenditure of obligations, and helping States build and maintain more effective behavioral health systems for prevention and treatment, services and recovery supports. Priority: Other Significant Agenda Stage of Rulemaking: Completed Action Unfunded Mandates: No Major: Yes CFR Citation: Not Yet Determined (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: Sections 1911 through 1956 of the Public Health Services (PHS) Act Authorize the Community Mental Health Services (CMHS) Block Grant and the Substance Abuse Prevention and Treatment (SAPT) Block Grant Legal Deadline: None Timetable:
Regulatory Flexibility Analysis Required: No Federalism: Yes Energy Affected: No Agency Contact: Joseph Denis Faha Director, DLEA, SAMHSA Department of Health and Human Services Substance Abuse and Mental Health Services Administration 5600 Fishers Lane Rockville , MD 20857 Phone: 301 443-7017 FAX: 301 443-1450 E-Mail: jfaha@samhsa.gov
Government Levels Affected: State
Department of Health and Human Services (HHS) Office of the Inspector General ( OIG )
Title: Medicare and State Health Care Programs: Fraud and Abuse; Revisions to the Office of Inspector General's Safe Harbors Under the Antikickback Status, Exclusion Authorities, and Civil Monetary Penalty Abstract: This rule would: 1) Safe Harbor Provisions: Add safe harbors under the anti-kickback statute addressing arrangements in the following areas (subject to certain conditions): waivers of Federal health care program beneficiary costsharing amounts in the context of certain government sponsored clinical trials and in the context of certain emergency medical services furnished by suppliers owned or operated by States or municipalities; certain local transportation provided to Federal health care program beneficiaries; certain waived or reduced cost-sharing amounts under Medicare Part D (codifying in regulations section 101(e) of the Medicare Prescription Drug Improvement and Modernization Act of 2003); and certain discounts in the price of "applicable drugs" of manufacturers furnished to "applicable beneficiaries" under the Medicare Coverage Gap Discount Program (pursuant to section 3301 of the Affordable Care Act of 2010). In addition, this rule would repropose expanding the existing safe harbor for certain waivers of beneficiary co-insurance and deductible amounts for Part A or Part B services for Medicare SELECT policyholders in accordance with an agreement between the Medicare SELECT issuer
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and a provider or supplier, in certain contexts. 2) OIG's Authority To Impose Civil Money Penalties and Assessments (610 Review): Revise 42 CFR part 1003, addressing the Office of Inspector General's authority to propose the imposition of civil money penalties and assessments by reorganizing and simplifying existing regulatory text and eliminating obsolete references contained in the current regulations. Among the proposed revisions, this rule would establish separate subparts within part 1003 for various categories of violations; clarify the availability of exclusion for certain violations in addition to civil money penalties and assessments; date various references to managed care organization authorities; and clarify the application of section 1140 of the Social Security Act with respect to the misuse of certain Departmental symbols, emblems, or names through Internet and e mail communications. 3) OIG's Exclusion Authority: In accordance with section 949 of the Medicare Prescription Drug Improvement and Modernization Act of 2003, and section 6402 of the Affordable care Act 0f 2010, this rule would revise the OIG's exclusion authority to permit any Federal health care program to request a waiver of an OIG exclusion imposed under sections 1128(a)(1), 1128(a)(3), or 1128(a)(4) of the Social Security Act if the exclusion would impose a hardship on beneficiaries. In addition, in accordance with sections 6406 and 6408 of the Affordable Care Act, the proposed rule would revise the OIG's exclusion authority to grant testimonial subpoena authority in exclusion cases; to add a new permissive exclusion authority for making false statements or misrepresentation of materials facts, and; to broaden the scope of certain permissive exclusion authorities. Finally, the proposed rule would revise current exclusion authorities in 42 CFR parts 1001, 1002, and 1005, to further clarify OIG's existing exclusion authorities. 4) Exceptions to the Beneficiary Inducement Prohibition for Certain Arrangements This proposed rule will codify section 6402(d)(2)(B) of the Affordable Care Act of 2010, entitled "Clarification of Treatment of Certain Charitable and Other Innocuous Programs." Section 1128A(a)(5) of the Social Security Act provides for a civil monetary penalty for certain inducements offered to Medicare and Medicaid beneficiaries. Section 6402(d)(2)(B) of the ACA adds four exceptions to the definition of remuneration at section 1128A(i)(6) of the Social Security Act for purposes of section 1128A(a)(5): certain remuneration which promotes access to care and poses a low risk of harm to patients and Federal health care programs (as defined in section 1128(f) of the Social Security Act and designated by the Secretary under regulations); certain offers or transfers in connection with retail rewards programs; certain unadvertised transfers of items or services to beneficiaries experiencing financial need; and certain waivers by PDP sponsors of Part D plans or MA organizations offering MA-PD plans of copayments otherwise owed by their enrollees for the first fill of a covered Part D drug that is a generic drug. Priority: Substantive, Nonsignificant Agenda Stage of Rulemaking: Proposed Rule Major: Undetermined Unfunded Mandates: No CFR Citation: 42 CFR 1001.952; 42 CFR 1001 and 1002; 42 CFR 1005; 42 CFR 1003.101; 42 CFR 1003; ... (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: PL 100-93, sec 14(a), sec; PL 111-148, sec 3301, sec 6402; PL 108-173, sec 101(eaaa0, sec 949; PL 10533, sec 4331, PL 99-660; PL 107-188; 42 USC 1320a-7a; 42 USC 1395mm; 42 USC 1395w-27; 42 USC 1396b Legal Deadline:
Action NPRM Source Statutory Description Date 11/00/2011
Timetable:
Regulatory Flexibility Analysis Required: No Federalism: No Agency Contact: Patrice S. Drew Regulations Analyst Department of Health and Human Services Office of the Inspector General 330 Independence Avenue SW. Washington , DC 20201 Phone: 202 619-1368 E-Mail: patrice.drew@hhs.gov
Department of Health and Human Services (HHS) Office of the Inspector General ( OIG )
Title: Revision to Prohibition on FFP for "Data Mining" by Medicaid Fraud Control Units Abstract: This notice proposes modifications to current regulations that prohibit State Medicaid Fraud Control Units (MFCUs) from using Federal matching funds to conduct efforts to identify situations in which a question of fraud may exist, including the screening of claims, analysis of patterns of practice, or routine verification with recipients of whether services billed by providers were actually received. The modifications would allow data mining to be conducted by MFCUs under limited circumstances.
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Priority: Other Significant Agenda Stage of Rulemaking: Final Rule Unfunded Mandates: No Major: No CFR Citation: 42 CFR 1007 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: 42 USC 1302; 42 USC 1396b(a)(6); 42USC 1396(b)(3); 42 USC 1396b(q) Legal Deadline: None Timetable:
Regulatory Flexibility Analysis Required: No Federalism: No Energy Affected: Undetermined Agency Contact: Patrice S. Drew Regulations Analyst Department of Health and Human Services Office of the Inspector General 330 Independence Avenue SW. Washington , DC 20201 Phone: 202 619-1368 E-Mail: patrice.drew@hhs.gov
Department of Health and Human Services (HHS) Office of Assistant Secretary for Health ( OASH )
Title: Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators Abstract: The Office of the Secretary of the Department of Health and Human Services (HHS) in coordination with the Office of Science and Technology Policy (OSTP) issued an advance notice of proposed rulemaking (ANPRM) to request comment on how current regulations for protecting human subjects who participate in research might be modernized and revised to be more effective. This ANPRM solicited comment on how to better protect human subjects who are involved in research, while facilitating valuable research and reducing burden, delay, and ambiguity for investigators. Revisions to the current human subjects regulations are being considered because OSTP and HHS believe these changes would strengthen protections for research subjects. Priority: Other Significant Major: No CFR Citation: 45 CFR 160; 45 CFR 164; 21 CFR 56; 21 CFR Regulations ) Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to Legal Deadline: None Timetable:
Action ANPRM ANPRM Comment Period End NPRM Date 07/26/2011 09/26/2011 03/00/2012 FR Cite 76 FR 44512
Agenda Stage of Rulemaking: Proposed Rule Unfunded Mandates: No 50 (To search for a specific CFR, visit the Code of Federal 353; 21 USC 355; 21 USC 360; 21 USC 371
Regulatory Flexibility Analysis Required: Undetermined Government Levels Affected: Undetermined Federalism: No Energy Affected: Undetermined Agency Contact: Jerry Menikoff Department of Health and Human Services Office of Assistant Secretary for Health 200 Independence Ave. SW Washington , DC 20201 97
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Department of Health and Human Services (HHS) Office of Assistant Secretary for Health ( OASH )
Title: Public Health Service Standards for the Protection of Research Misconduct Whistleblowers Abstract: To implement section 493(e) of the Public Health Service Act (added by sec. 163 of the National Institutes of Health Revitalization Act of 1993, Pub. L. 103-43), the Department is proposing to add a new part 94 to title 42 of the Code of Federal Regulations. Under this proposed regulation, covered institutions must follow certain requirements for preventing and responding to occurrences of retaliation against whistleblowers. The purpose of this part is to protect: 1) Persons who make a good faith allegation that a covered institution or member thereof engaged in, or failed to respond adequately, to an allegation of research misconduct; and 2) persons who cooperate in good faith with an investigation of research misconduct. Agenda Stage of Rulemaking: Completed Action Priority: Substantive, Nonsignificant Major: No Unfunded Mandates: No CFR Citation: 42 CFR 94 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: 42 USC 216 and 289b; 42 USC 241 Legal Deadline: None Timetable:
Action NPRM NPRM Comment Period End Withdrawn Date 11/28/2000 01/29/2001 10/25/2011 FR Cite 65 FR 70830
Regulatory Flexibility Analysis Required: No Government Levels Affected: No Small Entities Affected: No Federalism: No Related RINs: Related to 0940-AA04; Previously Reported as 0940-AA01 Agency Contact: John Dahlberg Senior Scientist Department of Health and Human Services Office of Assistant Secretary for Health 1101 Wootton Parkway Rockville , MD 20852 Phone: 301 443-5300 E-Mail: john.dahlberg@hhs.gov
Department of Health and Human Services (HHS) Centers for Medicare & Medicaid Services ( CMS )
RIN: 0938-AO53 View Related Documents
Title: Home and Community-Based State Plan Services Program and Provider Payment Reassignments (CMS-2249-P2) Abstract: This proposed rule would amend the Medicaid regulations to define and describe State plan home and communitybased services (HCBS) plan services under the Affordable Care Act. This proposed rule offers States new flexibilities in providing necessary and appropriate services to elderly and disabled populations and reflects CMS' commitment to the general principles of the President's Executive Order released January 18, 2011, entitled "Improving Regulation and Regulatory Review." In particular, this rule does not include the existing cumbersome eligibility link between HCBS and institutional care that exists under the Medicaid 1915(c) HCBS waiver program. This regulation would describe Medicaid coverage of a new optional State plan benefit to furnish home and community based State plan services and draw Federal matching funds. As a result, States will be better able to design and tailor Medicaid services to accommodate individual needs. This may result in improved patient outcomes and satisfaction, while enabling States to effectively manage their Medicaid resources. Priority: Economically Significant Major: Yes Agenda Stage of Rulemaking: Proposed Rule Unfunded Mandates: No 98
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CFR Citation: 42 CFR 431; 42 CFR 435; 42 CFR 436; 42 CFR 440; 42 CFR 441; 42 CFR 447 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: Deficit Reduction Act of 2005; PL 109-171, sec 6086;; PL 111-148, sec 2402(b)-(g) Legal Deadline:
Timetable:
Action NPRM NPRM Comment Period End Second NPRM Date 04/04/2008 06/03/2008 02/00/2012 FR Cite 73 FR 18676
Additional Information: Includes Retrospective Review under E.O. 13563. Regulatory Flexibility Analysis Required: No Small Entities Affected: Business Energy Affected: No Agency Contact: Suzanne Bosstick Director, Division of Integrated Health Systems Department of Health and Human Services Centers for Medicare & Medicaid Services 7500 Security Boulevard Baltimore , MD 21244 Phone: 410 786-1301 E-Mail: suzanne.bosstick@cms.hhs.gov Government Levels Affected: State Federalism: No
RIN: 0938-AQ13 View Related Documents
Title: Administrative Simplification: Standard Unique Identifier for Health Plans (CMS-0040-P) Abstract: This rule would implement provisions of the Affordable Care Act of 2010 under Administrative Simplification that establish a unique health plan identifier. This health plan identifier will be used to identify health plans in HIPAA standard transactions. Priority: Other Significant Agenda Stage of Rulemaking: Proposed Rule Major: Undetermined Unfunded Mandates: Undetermined CFR Citation: Not Yet Determined (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: PL 111-148, sec 1104 Legal Deadline:
Timetable:
Regulatory Flexibility Analysis Required: Undetermined Government Levels Affected: Undetermined Small Entities Affected: Business Federalism: Undetermined Energy Affected: No Agency Contact: Denise Buenning Director, Administrative Simplification Group, Office of E-Health Standards and Services Department of Health and Human Services Centers for Medicare & Medicaid Services Mail Stop S2-26-17 7500 Security Boulevard Baltimore , MD 21244 Phone: 410 786-6711
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Title: Medicaid Disproportionate Share Hospital Payments Uninsured Definition (CMS-2315-P) Abstract: This proposed rule addresses the hospital-specific limitation on Medicaid disproportionate share hospital (DSH) payments under section 1923(g)(1)(A) of the Social Security Act. Under this limitation, DSH payments to a hospital cannot exceed the uncompensated costs of furnishing hospital services by the hospital to individuals who are Medicaid-eligible or "have no health insurance (or other source of third party coverage) for the services furnished during the year." This rule would provide that the quoted phrase would refer in context to a lack of coverage on a service-specific basis, so that the calculation of uncompensated care for purposes of the hospital-specific Medicaid Disproportionate Share Hospital (DSH) limit would include the cost of each service furnished to an individual who had no health insurance or other source of third party coverage for that service. Priority: Other Significant Agenda Stage of Rulemaking: Proposed Rule Unfunded Mandates: No Major: No CFR Citation: 42 CFR 447 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: 1923(g) of the Social Security Act Legal Deadline: None Timetable:
Regulatory Flexibility Analysis Required: No Government Levels Affected: State Small Entities Affected: Business; Governmental Jurisdictions Federalism: No Energy Affected: No Agency Contact: Rory Howe Health Insurance Specialist Department of Health and Human Services Centers for Medicare & Medicaid Services Mail Stop S3-13-11 7500 Security Boulevard Baltimore , MD 21244 Phone: 410 786-8533 Extension: 68533 E-Mail: rory.howe@cms.hhs.gov
Title: Covered Outpatient Drugs (CMS-2345-P) Abstract: This proposed rule would revise requirements pertaining to Medicaid reimbursement for covered outpatient drugs to implement provisions of the Affordable Care Act. This proposed rule would also revise other requirements related to covered outpatient drugs, including key aspects of Medicaid coverage, payment, and the drug rebate program. Priority: Economically Significant Agenda Stage of Rulemaking: Proposed Rule Unfunded Mandates: No Major: Yes CFR Citation: 42 CFR 447 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: PL 111- 48, secs 2501 and 2503 Legal Deadline:
Timetable:
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Action NPRM

Date 01/00/2012 FR Cite
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Regulatory Flexibility Analysis Required: Business Government Levels Affected: State; Tribal Federalism: No Energy Affected: No Related RINs: Related to 0938-AP26; Related to 0938-AP67 Agency Contact: Wendy Tuttle Health Insurance Specialist Department of Health and Human Services Centers for Medicare & Medicaid Services Center for Medicaid and State Operations Mail Stop S2-14-26 7500 Security Boulevard Baltimore , MD 21244 Phone: 410 786-8690 E-Mail: wendy.tuttle@cms.hhs.gov
Title: Reporting and Returning of Overpayments (CMS-6037-P) Abstract: This proposed rule would implement section 6402(d) of the Affordable Care Act, which requires the Secretary establish a process for a provider or supplier to return an overpayment to the program, as well as establish a process for CMS and its contractors to receive and apply the overpayment. Priority: Other Significant Agenda Stage of Rulemaking: Proposed Rule Major: Yes Unfunded Mandates: No CFR Citation: 42 CFR 401 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: PL 111-148, 6402 (d) Legal Deadline: None Timetable:
Regulatory Flexibility Analysis Required: No Small Entities Affected: Business Agency Contact: John Spiegel Director, Program Integrity Group Department of Health and Human Services Centers for Medicare & Medicaid Services Mail Stop C3-02-16 7500 Security Boulevard Baltimore , MD 21244 Phone: 410 786-5704 E-Mail: john.spiegel@cms.hhs.gov
Government Levels Affected: State Federalism: No
Title: Payments for Primary Care Services Under the Medicaid Program (CMS-2370-P) Abstract: This proposed rule would implement section 1202 of the Affordable Care Act that requires payment by State Medicaid agencies of at least the Medicare rates in effect in calendar years (CYs) 2013 and 2014 for primary care services delivered by a physician with a specialty designation of family medicine, general internal medicine, or pediatric medicine. This rule would implement the statutory payment provisions uniformly across all States. Specifically, this proposed rule would define, for purposes of enhanced Federal match, eligible primary care providers and identify eligible primary care services, as well as
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specify how the enhanced payment should be calculated. This proposed rule would also provide general guidelines for implementing the enhanced payment for managed care services. Priority: Economically Significant Agenda Stage of Rulemaking: Proposed Rule Unfunded Mandates: No Major: Yes CFR Citation: 42 CFR 447 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: PL 111-152, sec 1202 Legal Deadline:
Timetable:
Regulatory Flexibility Analysis Required: No Federalism: No Energy Affected: No Agency Contact: Mary Cieslicki Health Insurance Specialist Department of Health and Human Services Centers for Medicare & Medicaid Services Mail Stop S3-14-28 7500 Security Boulevard Baltimore , MD 21244 Phone: 410 786-4576 E-Mail: mary.cieslicki@cms.hhs.gov
Title: Medicare and Medicaid Electronic Health Record Incentive Program--Stage 2 (CMS-0044-P) Abstract: The final rule for the Medicare and Medicaid EHR Incentive Programs, which was published in the Federal Register on July 28, 2010, specifies that CMS will expand on the criteria for meaningful use established for Stage 1 to advance the use of certified EHR technology by eligible professionals (EPs), eligible hospitals and critical access hospitals (CAHs). This proposed rule would establish the requirements for Stage 2. As stated in the July 28 final rule, "Our goals for the Stage 2 meaningful use criteria, consistent with other provisions of Medicare and Medicaid law, expand upon the Stage 1 criteria to encourage the use of health IT for continuous quality improvement at the point of care and the exchange of information in the most structured format possible, such as the electronic transmission of orders entered using computerized provider order entry (CPOE) and the electronic transmission of diagnostic test results." Priority: Economically Significant Agenda Stage of Rulemaking: Proposed Rule Unfunded Mandates: No Major: Yes CFR Citation: 42 CFR 412; 42 CFR 413; 42 CFR 422; 42 CFR 495 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: PL 111-5 secs 4101, 4102, and 4202 Legal Deadline: None Timetable:
Regulatory Flexibility Analysis Required: Business; Governmental Jurisdictions Federalism: No Energy Affected: No Related RINs: Related to 0938-AP78; Related to 0991-AB82 Agency Contact: Elizabeth Holland
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Director, Health Initiatives Group/Office of e-Health Standards and Services Department of Health and Human Services Centers for Medicare & Medicaid Services Mail Stop S2-26-17 7500 Security Boulevard Baltimore , MD 21244 Phone: 410 786-1309 E-Mail: elizabeth.holland@cms.hhs.gov
Title: Administrative Simplification: Compliance: Health Plan Certification (CMS-0037-P) Abstract: This rule proposes to implement provisions of the Affordable Care Act of 2010 under Administrative Simplification to certify that data and information systems are in compliance with any applicable standards and associated operating rules for electronic funds transfers, eligibility for a health plan, health claim status, and health care payment and remittance advice. Priority: Other Significant Agenda Stage of Rulemaking: Proposed Rule Major: Undetermined Unfunded Mandates: Undetermined CFR Citation: Not Yet Determined (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: PL 111-148, sec 1104 Legal Deadline:
Action Other Source Statutory Description First phase of compliance deadline is December 31, 2013; second phase of compliance to occur by December 31, 2015. Date 12/31/2013
Timetable:
Regulatory Flexibility Analysis Required: Undetermined Government Levels Affected: Undetermined Small Entities Affected: Business Federalism: Undetermined Energy Affected: No Agency Contact: Denise Buenning Director, Administrative Simplification Group, Office of E-Health Standards and Services Department of Health and Human Services Centers for Medicare & Medicaid Services Mail Stop S2-26-17 7500 Security Boulevard Baltimore , MD 21244 Phone: 410 786-6711 E-Mail: denise.buenning@cms.hhs.gov
Title: Policy and Technical Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit Programs for Contract Year 2013 (CMS-4157-F) Abstract: This rule sets forth programmatic and operational changes to the Medicare Advantage (MA) and prescription drug benefit programs for contract year 2013. Priority: Economically Significant Agenda Stage of Rulemaking: Proposed Rule Unfunded Mandates: No Major: Yes CFR Citation: 42 CFR 422; 42 CFR 423; 42 CFR 417 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: MMA 2003; PL 111-148; MIPPA Legal Deadline: None
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Timetable:
Additional Information: Includes Retrospective Review under E.O. 13563. Regulatory Flexibility Analysis Required: Undetermined Government Levels Affected: Federal Small Entities Affected: Business; Governmental Jurisdictions Federalism: No Energy Affected: Undetermined Agency Contact: Christian Bauer Health Insurance Specialist Department of Health and Human Services Centers for Medicare & Medicaid Services Mail Stop C1-26-16 7500 Security Boulevard Baltimore , MD 21244 Phone: 410 786-6043 E-Mail: christian.bauer@cms.hhs.gov
Title: Medicare and Medicaid Programs: Reform of Hospital and Critical Access Hospital Conditions of Participation (CMS3244-P) Abstract: This proposed rule would revise the requirements that hospitals and critical access hospitals (CAHs) must meet to participate in the Medicare and Medicaid programs. These changes are necessary to reflect substantial advances in health care delivery and in patient safety knowledge and practices. They are also an integral part of our efforts to achieve broad-based improvements in the quality of health care furnished through Federal programs and in patient safety, while at the same time reducing procedural burdens on providers. Agenda Stage of Rulemaking: Proposed Rule Priority: Economically Significant Major: Yes Unfunded Mandates: No CFR Citation: 42 CFR 482; 42 CFR 485 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: 42 USC 1302; 42 USC 1395hh and 1395rr Legal Deadline: None Regulatory Plan: Statement of Need: CMS is revising many of the hospital CoPs to ensure that they meet the needs of hospital and CAH patients in an effective and efficient manner. CMS is proposing changes to reduce unnecessary, obsolete, or burdensome regulations on U.S. hospitals. This retrospective review of existing regulations meets the President's Executive Order that all Federal agencies identify such rules and make proposals to "modify, streamline, expand, or repeal them." CMS is also proposing additional quality and safety requirements to protect patients. Legal Basis: The provisions that are included in this proposed rule are necessary to implement the requirements of Executive Order 13563 "Improving Regulations and Regulatory Review." Alternatives: To date, nearly 90 specific reforms have been identified and scheduled for action. These reforms impact hospitals, physicians, home health agencies, ambulance providers, clinical labs, skilled nursing facilities, intermediate care facilities, managed care plans, Medicare Advantage organizations, and States. Many of these reforms will be included in proposed rules that relate to particular categories of regulations or types of providers. Other reforms are being implemented without the need for regulations. This proposed rule includes reforms that do not fit directly in other rules scheduled for publication. Costs and Benefits: This proposed rule would reduce costs to tens of thousands of physicians, ambulatory surgical centers, End Stage Renal Disease facilities, and other small entities. Achieving the full scope of potential savings will depend on future decisions by hospitals, by State regulators, and others. Many other factors will influence long-term results. We believe, however, that likely savings and benefits will reach many billions of dollars. Our primary estimate of the net savings to hospitals from
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reductions in regulatory requirements that we can quantify at this time, offset by increases in other regulatory costs, are approximately $940 million a year. Risks: None. Timetable:
Regulatory Flexibility Analysis Required: Business Government Levels Affected: No Federalism: No Energy Affected: No Agency Contact: CDR Scott Cooper Health Insurance Specialist Department of Health and Human Services Centers for Medicare & Medicaid Services Clinical Standards Group Mail Stop S3-05-15 7500 Security Boulevard Baltimore , MD 21244 Phone: 410 786-9465 E-Mail: scott.cooper@cms.hhs.gov
Title: Long Term Care: Ethics and Compliance (CMS-3226-P) Abstract: This proposed rule would require skilled nursing facilities (SNFs) under Medicare and nursing facilities (NFs) under Medicaid to have an operational ethics and compliance program that is effective in promoting quality of care and preventing and detecting criminal, civil, and administrative violations. Priority: Other Significant Agenda Stage of Rulemaking: Proposed Rule Major: No Unfunded Mandates: No CFR Citation: 42 CFR 483 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: PL 111-148 6102 Legal Deadline:
Timetable:
Regulatory Flexibility Analysis Required: No Government Levels Affected: State Small Entities Affected: Business Federalism: No Energy Affected: No Agency Contact: Diane Corning Health Insurance Specialist Department of Health and Human Services Centers for Medicare & Medicaid Services Office of Clinical Standards and Quality Mail Stop S3-02-01 7500 Security Boulevard Baltimore , MD 21244 Phone: 410 786-8486 E-Mail: diane.corning@cms.hhs.gov
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View Related Documents
Title: Regulatory Provisions To Promote Program Efficiency, Transparency, and Burden Reduction (CMS-9070-P) Abstract: This proposed rule identifies and proposes reforms in Medicare and Medicaid regulations that CMS has identified as unnecessary, obsolete, or excessively burdensome on health care providers and beneficiaries. This proposed rule would increase the ability of health care professionals to devote resources to improving patient care, by eliminating or reducing requirements that impede quality patient care or that divert providing high quality patient care. Agenda Stage of Rulemaking: Proposed Rule Priority: Economically Significant Major: Yes Unfunded Mandates: No CFR Citation: 42 CFR 400, 405, 416, 418, 423; 42 CFR 424, 440, 442, 486, 494 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: 42 USC 1302 and 1395hh and 44 USC 35 Legal Deadline: None Regulatory Plan: Statement of Need: In January 2011, the President issued an Executive order that requires agencies to identify rules that may be "outmoded, ineffective, insufficient, or excessively burdensome, and to modify, streamline, expand, or repeal them in accordance with what has been learned." In accordance with the Executive order, we identified obsolete and unnecessarily burdensome rules that could be eliminated or reformed to achieve similar objectives, with a particular focus on freeing up resources that health care providers, health plans, and States could use to improve or enhance patient health and safety. We examined policies and practices not codified in rules that could be changed or streamlined to achieve better outcomes for patients while reducing burden on providers of care. We also sought to increase transparency and become a better business partner. Legal Basis: The provisions that are included in this proposed rule are necessary to implement the requirements of Executive Order 13563 "Improving Regulations and Regulatory Review." Alternatives: To date, nearly 90 specific reforms have been identified and scheduled for action. These reforms impact hospitals, physicians, home health agencies, ambulance providers, clinical labs, skilled nursing facilities, intermediate care facilities, managed care plans, Medicare Advantage organizations, and States. Many of these reforms will be included in proposed rules that relate to particular categories of regulations or types of providers. Other reforms are being implemented without the need for regulations. This proposed rule includes reforms that do not fit directly in other rules scheduled for publication. Costs and Benefits: We anticipate that the provider industry and health professionals would welcome the proposed changes and reductions in burden. We also expect that health professionals would experience increased efficiencies and resources to appropriately devote to improving patient care, increasing accessibility to care, and reducing associated health care costs. Risks: None. Timetable:
Regulatory Flexibility Analysis Required: No Government Levels Affected: Federal; State Small Entities Affected: Business; Governmental Jurisdictions; Federalism: No Organizations Agency Contact: Michelle Shortt Director, Regulations Development Group, OSORA Department of Health and Human Services Centers for Medicare & Medicaid Services Mailstop C4-26-05 7500 Security Boulevard Baltimore , MD 21244 Phone: 410 786-4675 E-Mail: michelle.shortt@cms.hhs.gov
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RIN: 0938-AR03 View Related Documents
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Title: Establishment of Exchange Program Part II; Appeals of Eligibility Determinations and Oversight and Financial Integrity (CMS-9980-P) Abstract: This proposed rule would implement section 1311 of the Affordable Care Act. This will be the second rule establishing the Qualified Health Plans and Health Benefit Exchanges as defined in the Affordable Care Act. This rule focuses on requirements for Qualified Health Plans and is more implementation-focused on elements such as the Essential Health Benefits and oversight of the Exchanges. Priority: Other Significant Agenda Stage of Rulemaking: Proposed Rule Unfunded Mandates: Undetermined Major: No CFR Citation: 45 CFR 156; 45 CFR 156; 45 CFR 157 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: PL 111-148 Legal Deadline:
Timetable:
Action Notice Comment Period End NPRM Date 09/14/2011 10/31/2011 04/00/2012 FR Cite 76 FR 56767
Regulatory Flexibility Analysis Required: Undetermined Government Levels Affected: Federal; Local; State; Tribal Small Entities Affected: Business; Governmental Jurisdictions; Federalism: Yes Organizations Energy Affected: No Agency Contact: Alissa Deboy Department of Health and Human Services Centers for Medicare & Medicaid Services 7500 Security Boulevard Baltimore , MD 21244 Phone: 301 492-4428 E-Mail: alissa.deboy@hhs.gov
Title: Medicaid Eligibility Changes Under the Affordable Care ActPart II (CMS-2334-P) Abstract: This proposed rule would implement provisions of the Affordable Care Act of 2010. The Affordable Care Act expands access to health insurance through improvements in Medicaid, the establishment of Affordable Insurance Exchanges (Exchanges), and coordination between Medicaid, the Children's Health Insurance Program (CHIP), and Exchanges. This proposed rule would set forth sections of the Affordable Care Act related to appeals, notices, and other Medicaid eligibility changes under the Affordable Care Act and options established by other Federal statutes. Priority: Economically Significant Agenda Stage of Rulemaking: Proposed Rule Major: Yes Unfunded Mandates: No CFR Citation: Not Yet Determined (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: PL 111-48; secs 1413, 2001, 2002, 2201 Legal Deadline:
Timetable:
Regulatory Flexibility Analysis Required: Undetermined Federalism: Undetermined
Government Levels Affected: Federal; Local; State; Tribal

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Energy Affected: No Agency Contact: Sarah Delone Senior. Policy Advisor Department of Health and Human Services Centers for Medicare & Medicaid Services Mailstop S2-01-16 7500 Security Boulevard Baltimore , MD 21244 Phone: 410 786-0615 E-Mail: sarah.delone2@cms.hhs.gov
Unified Agenda
Title: Proposed Changes to Hospital OPPS and CY 2013 Payment Rates; ASC Payment System and CY 2013 Payment Rates (CMS-1589-P) Abstract: This final rule would revise the Medicare hospital outpatient prospective payment system to implement applicable statutory requirements and changes arising from our continuing experience with this system. The proposed rule also describes changes to the amounts and factors used to determine payment rates for services. In addition, the rule proposes changes to the Ambulatory Surgical Center Payment System list of services and rates. Priority: Economically Significant Agenda Stage of Rulemaking: Proposed Rule Major: Yes Unfunded Mandates: Undetermined CFR Citation: 42 CFR 410; 42 CFR 416; 42 CFR 419 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: Sec 1833 of the Social Security Act Legal Deadline:
Regulatory Plan: Statement of Need: Medicare pays over 4,000 hospitals for outpatient department services under the hospital outpatient prospective payment system (OPPS). The OPPS is based on groups of clinically similar services called ambulatory payment classification groups (APCs). CMS annually revises the APC payment amounts based on the most recent claims data, proposes new payment policies, and updates the payments for inflation using the hospital operating market basket. The proposed rule solicits comments on the proposed OPPS payment rates and new policies. Medicare pays roughly 5,000 Ambulatory Surgical Centers (ASCs) under the ASC payment system. CMS annually revises the payment under the ASC payment system, proposes new policies, and updates payments for inflation using the Consumer Price Index for All Urban Consumers (CPI-U). CMS will issue a final rule containing the payment rates for the 2013 OPPS and ASC payment system at least 60 days before January 1, 2013. Legal Basis: Section 1833 of the Social Security Act establishes Medicare payment for hospital outpatient services and ASC services. The final rule revises the Medicare hospital OPPS and ASC payment system to implement applicable statutory requirements. In addition, the proposed and final rules describe changes to the outpatient APC system, relative payment weights, outlier adjustments, and other amounts and factors used to determine the payment rates for Medicare hospital outpatient services paid under the prospective payment system, as well as changes to the rates and services paid under the ASC payment system. These changes would be applicable to services furnished on or after January 1, 2013. Alternatives: None. This is a statutory requirement. Costs and Benefits: Total expenditures will be adjusted for CY 2013. Risks: If this regulation is not published timely, outpatient hospital and ASC services will not be paid appropriately beginning January 1, 2013. Timetable:
Regulatory Flexibility Analysis Required: Business Federalism: Undetermined
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Energy Affected: No Agency Contact: Paula Smith Health Insurance Specialist Department of Health and Human Services Centers for Medicare & Medicaid Services Mail Stop C4-05-13 7500 Security Blvd Baltimore , MD 21244 Phone: 410 786-4709 E-Mail: paula.smith@cms.hhs.gov
Unified Agenda
Title: Revisions to Payment Policies Under the Physician Fee Schedule and Part B for CY 2013 (CMS-1590-P) Abstract: This annual proposed rule would revise payment polices under the physician fee schedule, as well as other policy changes to payment under Part B. These changes would be applicable to services furnished on or after January 1. Priority: Economically Significant Agenda Stage of Rulemaking: Proposed Rule Unfunded Mandates: Undetermined Major: Yes CFR Citation: Not Yet Determined (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: Social Security Act, secs 1102, 1871, 1848 Legal Deadline:
Regulatory Plan: Statement of Need: The statute requires that we establish each year, by regulation, payment amounts for all physicians' services furnished in all fee schedule areas. This major proposed rule would implement changes affecting Medicare Part B payment to physicians and other Part B suppliers. The final rule has a statutory publication date of November 1, 2012, and an implementation date of January 1, 2013. Legal Basis: Section 1848 of the Social Security Act (the Act) establishes the payment for physician services provided under Medicare. Section 1848 of the Act imposes a deadline of no later than November 1 for publication of the final rule or final physician fee schedule. Alternatives: None. This implements a statutory requirement. Costs and Benefits: Total expenditures will be adjusted for CY 2013. Risks: If this regulation is not published timely, physician services will not be paid appropriately, beginning January 1, 2013. Timetable:
Regulatory Flexibility Analysis Required: Business Federalism: Undetermined Energy Affected: Undetermined Agency Contact: Christina Ritter Director, Division of Practitioner Services Department of Health and Human Services Centers for Medicare & Medicaid Services Mail Stop C4-03-06 7500 Security Blvd Baltimore , MD 21244 Phone: 410 786-4636 E-Mail: christina.ritter@cms.hhs.gov
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Title: Changes to the Hospital Inpatient an Long-Term Care Prospective Payment System for FY 2013 (CMS-1588-P) Abstract: This annual major proposed rule would revise the Medicare hospital inpatient and long-term care hospital prospective payment systems for operating and capital-related costs. This proposed rule would implement changes arising from our continuing experience with these systems. Priority: Economically Significant Agenda Stage of Rulemaking: Proposed Rule Unfunded Mandates: Undetermined Major: Yes CFR Citation: 42 CFR 412 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: Sec 1886(d) of the Social Security Act Legal Deadline:
Action NPRM Other Source Statutory Statutory Description Date 04/01/2012 08/01/2012
Regulatory Plan: Statement of Need: CMS annually revises the Medicare hospital inpatient prospective payment systems (IPPS) for operating and capital-related costs to implement changes arising from our continuing experience with these systems. In addition, we describe the proposed changes to the amounts and factors used to determine the rates for Medicare hospital inpatient services for operating costs and capital-related costs. Also, CMS annually updates the payment rates for the Medicare prospective payment system (PPS) for inpatient hospital services provided by long-term care hospitals (LTCHs). The proposed rule solicits comments on the proposed IPPS and LTCH payment rates and new policies. CMS will issue a final rule containing the payment rates for the FY 2013 IPPS and LTCHs at least 60 days before October 1, 2012. Legal Basis: The Social Security Act (the Act) sets forth a system of payment for the operating costs of acute care hospital inpatient stays under Medicare Part A (Hospital Insurance) based on prospectively set rates. The Act requires the Secretary to pay for the capital-related costs of hospital inpatient and Long Term Care stays under a PPS. Under these systems, Medicare payment for hospital inpatient and Long Term Care operating and capital-related costs is made at predetermined, specific rates for each hospital discharge. These changes would be applicable to services furnished on or after October 1, 2012. Alternatives: None. This implements a statutory requirement. Costs and Benefits: Total expenditures will be adjusted for FY 2013. Risks: If this regulation is not published timely, inpatient hospital and LTCH services will not be paid appropriately beginning October 1, 2012. Timetable:
Regulatory Flexibility Analysis Required: Business Government Levels Affected: Federal Federalism: No Energy Affected: No Agency Contact: Ankit Patel Health Insurance Specialist, Division of Acute Care Department of Health and Human Services Centers for Medicare & Medicaid Services Hospital and Ambulatory Policy Group Mail Stop, C4-25-11 7500 Security Boulevard Baltimore , MD 21244 Phone: 410 786-4537 E-Mail: ankit.patel@cms.hhs.gov

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Title: Changes to the End-Stage Renal Disease Prospective Payment System for CY 2013 (CMS-1352-P) Abstract: This annual proposed rule would update the bundled payment system for End Stage Renal Disease (ESRD) facilities as required by MIPPA. These changes would be applicable to services furnished on or after January 1. Priority: Economically Significant Agenda Stage of Rulemaking: Proposed Rule Unfunded Mandates: Undetermined Major: Yes CFR Citation: 42 CFR 410; 42 CFR 413; 42 CFR 414 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: sec 1881 of the Social Security Act, MIPPA sec 153 (c) Legal Deadline:
Timetable:
Regulatory Flexibility Analysis Required: Undetermined Small Entities Affected: Business Energy Affected: No Agency Contact: Janet Samen Director, Division of Chronic Care Management Department of Health and Human Services Centers for Medicare & Medicaid Services Mail Stop C5-05-27 7500 Security Boulevard Baltimore , MD 21244 Phone: 410 786-4533 E-Mail: janet.samen@cms.hhs.gov
Government Levels Affected: Federal Federalism: Undetermined
Title: Hospice Wage Index for FY 2013 (CMS-1434-P) Abstract: This proposed rule would announce the annual update to the hospice wage index (beginning October 1st) that reflects local differences in wage levels. Priority: Other Significant Agenda Stage of Rulemaking: Proposed Rule Unfunded Mandates: Undetermined Major: Undetermined CFR Citation: 42 CFR 418 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: 1814(i) (1) of the Act; 1814(i) (2) Legal Deadline:
Timetable:
Regulatory Flexibility Analysis Required: Undetermined Small Entities Affected: Business Energy Affected: Undetermined Agency Contact: Katherine Lucas Health Insurance Specialist Department of Health and Human Services Centers for Medicare & Medicaid Services Mailstop C5-08-23 7500 Security Boulevard Baltimore , MD 21244 Phone: 410 786-7723
Government Levels Affected: Undetermined Federalism: Undetermined
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E-Mail: katherine.lucas@cms.hhs.gov
Unified Agenda
Title: Home Health Prospective Payment System Rate for CY 2013 (CMS-1358-P) Abstract: This proposed rule would update the 60-day national episode rate based on the applicable home health market basket update and case-mix adjustment. It would also update the national per-visit rates used to calculate low utilization payment adjustments (LUPAs) and outlier payments under the Medicare prospective payment system for home health agencies. These changes would be applicable to services furnished on or after January 1. Agenda Stage of Rulemaking: Proposed Rule Priority: Economically Significant Major: Yes Unfunded Mandates: Undetermined CFR Citation: 42 CFR 484 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: Social Security Act, secs 1102 and 1871; 42 USC 1302 and 42 USC 1395(hh); Social Security Act, sec 1895; 42 USC 1395(fff) Legal Deadline:
Timetable:
Regulatory Flexibility Analysis Required: Undetermined Federalism: Undetermined Energy Affected: Undetermined Agency Contact: Randy Throndset Health Insurance Specialist Department of Health and Human Services Centers for Medicare & Medicaid Services Mailstop C5-08-17 7500 Security Boulevard Baltimore , MD 21244 Phone: 410 786-0131 E-Mail: randy.throndset@cms.hhs.gov
Title: Prospective Payment System and Consolidated Billing for Skilled Nursing FacilitiesUpdate for FY 2013 (CMS-1432-P) Abstract: This rule would update the payment rates used under the prospective payment system for skilled nursing facilities beginning October 1st. Priority: Economically Significant Agenda Stage of Rulemaking: Proposed Rule Unfunded Mandates: Undetermined Major: Yes CFR Citation: 42 CFR 483 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: Social Security Act, sec 1888(e) Legal Deadline:
Timetable:
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Regulatory Flexibility Analysis Required: Undetermined Federalism: No Energy Affected: No Agency Contact: Bill Ullman Center for Medicare Management, Chronic Care Policy Group Department of Health and Human Services Centers for Medicare & Medicaid Services Mailstop C5-06-24 7500 Security Boulevard Baltimore , MD 21244-1850 Phone: 410 786-5667 Extension: 6-5667 E-Mail: bill.ullman@cms.hhs.gov
Title: Prospective Payment System for Inpatient Rehabilitation Facilities for FY 2013 (CMS-1433-P) Abstract: This proposed rule would update rates for the prospective payment system for inpatient rehabilitation facilities. Priority: Economically Significant Agenda Stage of Rulemaking: Proposed Rule Major: Yes Unfunded Mandates: Undetermined CFR Citation: 42 CFR 412 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: Social Security Act, sec 1886(j); PL 106-554; PL 106-113 Legal Deadline:
Timetable:
Regulatory Flexibility Analysis Required: Undetermined Government Levels Affected: Undetermined Federalism: No Energy Affected: No Agency Contact: Julie Stankivic Health Insurance Specialist Department of Health and Human Services Centers for Medicare & Medicaid Services Department of Health and Human Services Mailstop, C5-06-27 7500 Security Boulevard Baltimore , MD 21244 Phone: 410 786-5725 E-Mail: julie.stankivic@cms.hhs.gov
Title: Inpatient Psychiatric Facility Prospective Payment System--Update for Fiscal Year 2013 (CMS-1440-P) Abstract: This rule is necessary to update the prospective payment rates for inpatient psychiatric facilities with discharges beginning October 1st. Agenda Stage of Rulemaking: Proposed Rule Priority: Other Significant Major: Undetermined Unfunded Mandates: Undetermined CFR Citation: 42 CFR 412.400, subpart N (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: PL 106-113, sec 124 BBRA 113
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Description
Date 08/01/2012
Timetable:
Regulatory Flexibility Analysis Required: No Small Entities Affected: Business Energy Affected: Undetermined Agency Contact: Janet Samen Director, Division of Chronic Care Management Department of Health and Human Services Centers for Medicare & Medicaid Services Mail Stop C5-05-27 7500 Security Boulevard Baltimore , MD 21244 Phone: 410 786-4533 E-Mail: janet.samen@cms.hhs.gov
Government Levels Affected: Local Federalism: No
Title: Disproportionate Share Hospital Payment Reduction (CMS-2367-P) Abstract: The Affordable Care Act amends the Social Security Act by requiring aggregate reductions to state Medicaid DSH allotments from FY 2014 through FY 2020. The annual reduction amounts are specified in statute and must be implemented using a DSH Health Reform methodology determined by the Secretary. This proposed rule will delineate the DSH Health Reform methodology required to implement the reductions. Agenda Stage of Rulemaking: Proposed Rule Priority: Economically Significant Major: Undetermined Unfunded Mandates: No CFR Citation: Not Yet Determined (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: PL 111-148, sec 1203 Legal Deadline: The Affordable Care Act requires aggregate reductions to state Medicaid DSH allotments beginning in FY 2014 (October 1, 2013).
Timetable:
Regulatory Flexibility Analysis Required: Undetermined Small Entities Affected: Governmental Jurisdictions Agency Contact: Rory C. Howe Financial Management Specialist Department of Health and Human Services Centers for Medicare & Medicaid Services Mailstop S3-14-02 7500 Security Boulevard Baltimore , MD 21244 Phone: 410 786-4878 FAX: 410 786-8533 E-Mail: rory.howe@cms.hhs.gov
Government Levels Affected: Federal; State Federalism: Undetermined

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Centers for Medicare & Medicaid Services ( CMS )
Title: Transparency Reports and Reporting of Physician Ownership of Investment Interests (CMS-5060-F) Abstract: This final rule requires applicable manufacturers of drugs, devices, biologicals, or medical supplies covered by Medicare, Medicaid, or CHIP to report annually to the Secretary certain payments or transfers of value provided to physicians or teaching hospitals ("covered recipients"). In addition, applicable manufacturers and applicable group purchasing organizations (GPOs) are required to report annually certain physician ownership or investment interests. The Secretary is required to publish applicable manufacturers' and applicable GPOs' submitted payment and ownership information on a public website. Priority: Economically Significant Agenda Stage of Rulemaking: Proposed Rule Unfunded Mandates: Private Sector Major: Yes CFR Citation: 42 CFR 402; 42 CFR 403 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: PL 111-148, sec 6002 Legal Deadline:
Timetable:
Regulatory Flexibility Analysis Required: Business Federalism: No Agency Contact: Niall Brennan Director, Policy and Data Analysis Group Department of Health and Human Services Centers for Medicare & Medicaid Services 7500 Security Blvd, Baltimore, , MD 21244 Phone: 202 690-6627 E-Mail: niall.brennan@cms.hhs.gov
RIN: 0938-AP64 View Related Documents
Title: Medicare Advantage and Prescription Drug Benefit Programs; Payments to Sponsors of Retiree Prescription Drug Plans (CMS-4131-F2) Abstract: This rule will specify whether Retiree Drug Subsidy plan sponsors can continue to choose to report either the "passthrough price" or the "lock-in price" when reporting Part D drug cost data. Priority: Other Significant Agenda Stage of Rulemaking: Final Rule Major: No Unfunded Mandates: No CFR Citation: 42 CFR 422 and 423 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: 42 USC 1302; 42 USC 1395w-101 to 1395w-152; 42 USC 1395hh Legal Deadline:
Action Other Source Statutory MMA section 902 Description Date 01/12/2012
Timetable:
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Regulatory Flexibility Analysis Required: No Small Entities Affected: Business Agency Contact: James Slade Health Insurance Specialist Department of Health and Human Services Centers for Medicare & Medicaid Services Mail Stop C1-13-15 7500 Security Boulevard Baltimore , MD 21244 Phone: 410 786-1073 E-Mail: james.slade@cms.hhs.gov

Unified Agenda
Title: Administrative Simplification: Adoption of Standards for Electronic Funds Transfer (EFT) (CMS-0024-IFC) Abstract: This rule implements provisions of the Affordable Care Act of 2010 under Administrative Simplification that require the adoption of standards for Electronic Funds Transfers (EFT). Priority: Economically Significant Agenda Stage of Rulemaking: Final Rule Unfunded Mandates: No Major: Yes CFR Citation: Not Yet Determined (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: PL 111-148, sec 1104 Legal Deadline:
Timetable:
Action Interim Final Rule Date 01/00/2012 FR Cite
Regulatory Flexibility Analysis Required: Undetermined Government Levels Affected: Undetermined Small Entities Affected: Business Federalism: No Energy Affected: No Agency Contact: Denise Buenning Director, Administrative Simplification Group, Office of E-Health Standards and Services Department of Health and Human Services Centers for Medicare & Medicaid Services Mail Stop S2-26-17 7500 Security Boulevard Baltimore , MD 21244 Phone: 410 786-6711 E-Mail: denise.buenning@cms.hhs.gov
Title: Medicaid and Children's Health Insurance Programs; Disallowance of Claims for FFP and Technical Corrections (CMS2292-F) Abstract: This rule reflects the Centers for Medicare and Medicaid Services' commitment to the general principles of the President's Executive Order 13563 released January 18, 2011, entitled "Improving Regulation and Regulatory Review," as this rule will: (1) Implement a new reconsideration process for administrative determinations to disallow claims for Federal financial participation (FFP) under title XIX of the Act (Medicaid); (2) lengthen the time States have to credit the Federal Government for identified but uncollected Medicaid provider overpayments; (3) make conforming changes to the Medicaid and Children's Health Insurance Program (CHIP) disallowance process to allow States the option to retain disputed Federal funds through the new administrative reconsideration process; (4) revise installment repayment standards and schedules for States that owe significant amounts; (5) clarify that interest charges may accrue during the new administrative reconsideration process if a State chooses 116
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to retain the funds during that period. This rule also makes a technical correction to reporting requirements for disproportionate share hospital payments, revises internal delegations of authority to reflect current CMS structure; removes obsolete language; and corrects other technical errors. Priority: Other Significant Agenda Stage of Rulemaking: Final Rule Unfunded Mandates: No Major: No CFR Citation: 42 CFR 430; 42 CFR 433; 42 CFR 447; 42 CFR 457 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: 42 USC 1316; PL 111-148; PL 110-275 Legal Deadline:
Timetable:
Additional Information: Includes Retrospective Review under E.O. 13563. Regulatory Flexibility Analysis Required: No Federalism: No Agency Contact: Robert Lane Financial Management Specialist Department of Health and Human Services Centers for Medicare & Medicaid Services Mail Stop S3-14-16 7500 Security Boulevard Baltimore , MD 21244 Phone: 410 786-2015 Extension: 62015 E-Mail: robert.lane@cms.hhs.gov Government Levels Affected: State
Title: Community First Choice Option (CMS-2337-F) Abstract: This rule implements section 2401 of the Affordable Care Act (ACA) which establishes a new State option to provide home and community-based attendant services and supports. These services and supports may be offered through the Community First Choice State plan option. Priority: Economically Significant Agenda Stage of Rulemaking: Final Rule Major: Yes Unfunded Mandates: No CFR Citation: 42 CFR 441 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: PL 111-148, sec 2401; PL 111-152, sec 1205 Legal Deadline:
Timetable:
Regulatory Flexibility Analysis Required: No Small Entities Affected: Business Energy Affected: No

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Agency Contact: Melissa Harris Technical Director Department of Health and Human Services Centers for Medicare & Medicaid Services Center for Medicaid, CHIP and Survey & Certification S2-14-26 7500 Security Boulevard Baltimore , MD 21244 Phone: 410 786-3397 E-Mail: melissa.harris@cms.hhs.gov
Title: Face-to-Face Requirements for Home Health Services; Policy Changes and Clarifications Related to Home Health (CMS2348-F) Abstract: This rule revises the Medicaid home health service definition as required by section 6407 of the Affordable Care Act of 2010 to add a requirement that physicians document the existence of a face-to-face encounter (including through the use of telehealth) with the Medicaid eligible individual within reasonable timeframes. This aligns the timeframes with similar regulatory requirements for Medicare home health services in accordance with section 6407 of the Affordable Care Act and reflects CMS' commitment to the general principles of the President's Executive Order 13563 released January 18, 2011, entitled "Improving Regulation and Regulatory Review." In addition, this rule amends home health services regulations at section 440.70 to clarify the definitions of included medical supplies, equipment and appliances, and clarify that States may not limit home health services to services delivered in the home, or to services furnished to individuals who are homebound. Priority: Economically Significant Agenda Stage of Rulemaking: Final Rule Unfunded Mandates: No Major: Yes CFR Citation: 42 CFR 440 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: PL 111-148, sec 6407(d) Legal Deadline:
Timetable:
Additional Information: Includes Retrospective Review under E.O. 13563. Regulatory Flexibility Analysis Required: No Government Levels Affected: State Federalism: No Small Entities Affected: No Energy Affected: No Agency Contact: Melissa Harris Technical Director Department of Health and Human Services Centers for Medicare & Medicaid Services Center for Medicaid, CHIP and Survey & Certification S2-14-26 7500 Security Boulevard Baltimore , MD 21244 Phone: 410 786-3397 E-Mail: melissa.harris@cms.hhs.gov
Title: Review and Approval Process for Section 1115 Demonstrations (CMS-2325-F) 118
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Abstract: This final rule will implement provisions of the Affordable Care Act of 2010 that set forth transparency and public notice procedures for experimental, pilot, and demonstration projects approved under section 1115 of the Social Security Act relating to Medicaid and the Children's Health Insurance Program (CHIP). This rule will increase the degree to which information about Medicaid and CHIP demonstration applications and approved demonstration projects is publicly available and promote greater transparency in the review and approval of demonstrations. It will also codify existing statutory requirements pertaining to seeking advice from Indian health care providers and urban Indian organizations for section 1115 demonstration projects, and for the first time impose as regulatory requirements tribal consultation standards that were previously only published as guidance documents. Priority: Other Significant Agenda Stage of Rulemaking: Final Rule Unfunded Mandates: No Major: No CFR Citation: 42 CFR 431 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: PL 111-148, sec 10201 Legal Deadline:
Timetable:
Regulatory Flexibility Analysis Required: No Small Entities Affected: No Energy Affected: No Agency Contact: Steven Rubio Health Insurance Specialist Department of Health and Human Services Centers for Medicare & Medicaid Services Mail Stop S2-01-16 7500 Security Boulevard Baltimore , MD 21244 Phone: 410 786-1782 E-Mail: steven.rubio@cms.hhs.gov
Title: Emergency Medical Treatment and Labor Act: Applicability to Hospital Inpatients and Hospitals with Specialized Capabilities (CMS-1350-N) Abstract: This notice addresses the applicability of Emergency Medical Treatment and Labor Act (EMTALA) to hospital inpatients and the responsibilities of hospitals with specialized capabilities. Priority: Other Significant Agenda Stage of Rulemaking: Final Rule Major: No Unfunded Mandates: No CFR Citation: 42 CFR 489 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: 42 USC 1395cc; 42 USC 1395dd Legal Deadline: None Timetable:
Action ANPRM ANPRM Comment Period End Notice Date 12/23/2010 02/22/2011 01/00/2012 FR Cite 75 FR 80762
Regulatory Flexibility Analysis Required: No Small Entities Affected: No

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Related RINs: Related to 0938-AM34; Related to 0938-AP15 Agency Contact: Tzvi Hefter Division Director Department of Health and Human Services Centers for Medicare & Medicaid Services Centers for Medicare Management Mail Stop, C4-07-07 7500 Security Boulevard Baltimore , MD 21244 Phone: 410 786-0614 E-Mail: tzvi.hefter@cms.hhs.gov
Title: Methods for Assuring Access to Covered Medicaid Services (CMS-2328-F) Abstract: This rule creates a standardized, transparent process for States to follow as part of their broader efforts to "assure that payments are consistent with efficiency, economy, and quality of care and are sufficient to enlist enough providers so that care and services are available under the plan at least to the extent that such care and services are available to the general population in the geographic area" as required by section 1902(a)(30)(A) of the Social Security Act (the Act). This rule also recognizes, as States have requested, electronic publication as an optional means of communicating State plan amendments (SPAs) proposed rate-setting policy changes to the public. Agenda Stage of Rulemaking: Final Rule Priority: Other Significant Major: No Unfunded Mandates: No CFR Citation: 42 CFR 447 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: 42 USC 1396 to 1396v; 1902(a)(30)(A) of the Social Security Act Legal Deadline: None Timetable:
Regulatory Flexibility Analysis Required: No Government Levels Affected: State Small Entities Affected: No Federalism: No Energy Affected: No Agency Contact: Jeremy Silanskis Health Insurance Specialist Department of Health and Human Services Centers for Medicare & Medicaid Services Center for Medicaid and State Operations Mail Stop S3-13-15 7500 Security Boulevard Baltimore , MD 21244 Phone: 410 786-1592 FAX: 410 786-8533 E-Mail: jeremy.silanskis@cms.hhs.gov
Title: Medicaid Eligibility Expansion Under the Affordable Care Act of 2010 (CMS-2349-F) Abstract: This rule implements provisions of the Affordable Care Act expanding access to health insurance through improvements in Medicaid, the establishment of American Health Benefit Exchanges ("Exchanges"), and coordination between Medicaid, the Children's Health Insurance Program (CHIP), and Exchanges. This rule also implements sections of the Affordable Care Act related to Medicaid eligibility, enrollment simplification, and coordination.
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Priority: Economically Significant Agenda Stage of Rulemaking: Final Rule Major: Yes Unfunded Mandates: No CFR Citation: 42 CFR 431, 435, 457 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: PL 111-148, secs 1413,1414, 2001, 2002, 2101, 2201 Legal Deadline:
Regulatory Plan: Statement of Need: This rule expands Medicaid eligibility, simplifies Medicaid eligibility procedures, and streamlines Medicaid enrollment processes. It also coordinates eligibility processes and policies with the processes for premium tax credits for Exchange coverage. Millions of uninsured low-income persons who do not have access to, or could not afford, health insurance will obtain coverage. Legal Basis: The provisions that are included in this rule are necessary to implement the requirements of sections 1413, 1414, 2001, 2002, 2101, and 2201 of the Affordable Care Act. Alternatives: None. This is a statutory requirement. Costs and Benefits: We anticipate that this rule provides significant benefits to low-income individuals by expanding the availability of affordable health coverage. We expect that States may incur short term increases in administrative costs (depending on their current systems and practices) but that these costs will be wholly offset by administrative savings over the longer term. Risks: None. Timetable:
Regulatory Flexibility Analysis Required: Undetermined Small Entities Affected: Governmental Jurisdictions Energy Affected: No Agency Contact: Sarah DeLone Health Insurance Specialist Department of Health and Human Services Centers for Medicare & Medicaid Services Mail Stop S2-01-16 7500 Security Boulevard Baltimore , MD 21244 Phone: 410 786-0615 E-Mail: sarah.delone@cms.hhs.gov
Government Levels Affected: Federal; Local; State; Tribal Federalism: No
Title: Establishment of Exchanges and Qualified Health Plans Part I (CMS-9989-F) Abstract: This rule implements the new Affordable Insurance Exchanges ("Exchanges"), consistent with title I of the Affordable Care Act of 2010, referred to collectively as the Affordable Care Act. The Exchanges will provide competitive marketplaces for individuals and small employers to directly compare available private health insurance options on the basis of price, quality, and other factors. The Exchanges, which will become operational by January 1, 2014, will help enhance competition in the health insurance market, improve choice of affordable health insurance, and give small businesses the same purchasing clout as large businesses. Priority: Economically Significant Agenda Stage of Rulemaking: Final Rule Unfunded Mandates: No Major: Yes CFR Citation: 45 CFR 155 to 157 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: Affordable Care Act, secs 1301 to 1343, secs 1401 to 1413
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Description
Date 01/01/2014
Regulatory Plan: Statement of Need: A central aim of Title I of the Affordable Care Act is to expand access to health insurance coverage through the establishment of Exchanges. The number of uninsured Americans is rising due to the lack of affordable insurance, barriers to insurance for people with pre-existing conditions, and high prices due to limited competition and market failures. Millions of people without health insurance use health care services for which they do not pay, shifting the uncompensated cost of their care to health care providers. Providers pass much of this cost to insurance companies, resulting in higher premiums that make insurance unaffordable to even more people. The Affordable Care Act includes a number of policies to address these problems, including the creating of Affordable Insurance Exchanges. Legal Basis: This rule implements the new Affordable Insurance Exchanges consistent with title I of the Affordable Care Act of 2010. Alternatives: None. This is a statutory requirement. Costs and Benefits: This rule will help enhance competition in the health insurance market, promote the choice of affordable health insurance, and give small businesses the same purchasing clout as large businesses. States seeking to operate an Exchange will incur administrative expenses as a result of implementing and subsequently maintaining Exchanges. There is no Federal requirement that each State establish an Exchange. Risks: If this regulation is not published, the Exchanges will not become operational by January 1, 2014, thereby violating the statute. Timetable:
Regulatory Flexibility Analysis Required: Undetermined Government Levels Affected: Federal; State; Tribal Small Entities Affected: Business; Governmental Jurisdictions Federalism: Yes Energy Affected: No Agency Contact: Alissa DeBoy Department of Health and Human Services Department of Health and Human Services Centers for Medicare & Medicaid Services 7500 Security Boulevard Baltimore , MD 21244 Phone: 301 492-4428 E-Mail: alissa.deboy@cms.hhs.gov
Title: Uniform Disclosure to Consumers: Benefit Design, Cost Sharing, & Standards for Definitions (CMS-9982-F) Abstract: The Affordable Care Act requires the Secretary to develop standards for use by group health plans and health insurance issuers in compiling and providing a summary of benefits and coverage explanation that accurately describes benefits and coverage. The Secretary must also set standards for the definitions of terms used in health insurance coverage, including specific terms set out in the statute. Plans and issuers must provide information according to these standards no later than 24 months after enactment. This rule implements the information disclosure provisions in section 2715 of the Public Health Service Act, as added by the Affordable Care Act. Priority: Other Significant Agenda Stage of Rulemaking: Final Rule Unfunded Mandates: No Major: No CFR Citation: 45 CFR 153, Insurance Rules (sec 2715) (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: PL 111-148, title I, subtitle A, sec 1001 (Public Health Service Act, sec 2715)
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Description
Date 03/23/2011
Timetable:
Regulatory Flexibility Analysis Required: Undetermined Federalism: No Energy Affected: Undetermined Agency Contact: Jacob Ackerman Program Analyst Department of Health and Human Services Centers for Medicare & Medicaid Services 7500 Security Boulevard Baltimore , MD 21244 Phone: 301 492-4262 E-Mail: jacob.ackerman@cms.hhs.gov
Title: Affordable Care Act Waiver for State Innovation; Review and Approval Process (CMS-9987-F) Abstract: The Affordable Care Act requires that the Secretary issue regulations regarding the Waiver for State Innovation. This regulation provides a process for public notice and comment at the State level, including public hearings, sufficient to ensure a meaningful level of public input; a process for the submission of an application that ensures the disclosure of the provisions of law that the state involved seeks to waive and the specific plans of the State to ensure that the waiver will be in compliance with subsection (b) of section 1332 of the Affordable Care Act; a process for providing public notice and comment after the application is received by the Secretary, that is sufficient to ensure a meaningful level of public input and that does not impose requirements that are in addition to, or duplicative of, requirements imposed under the Administrative Procedures Act, or requirements that are unreasonable or unnecessarily burdensome with respect to state compliance; a process for the submission to the Secretary of periodic reports by the state concerning the implementation of the program under the waiver; and a process for the periodic evaluation by the Secretary of the program under the waiver. Priority: Other Significant Agenda Stage of Rulemaking: Final Rule Unfunded Mandates: No Major: No CFR Citation: 45 CFR 155 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: PL 111-148 Legal Deadline:
Timetable:
Regulatory Flexibility Analysis Required: No Federalism: No Related Agencies: Joint : TREAS Agency Contact: Ben Walker Health Insurance Specialist Department of Health and Human Services Centers for Medicare & Medicaid Services
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Department of Treasury 7500 Security Boulevard Baltimore , MD 21244 Phone: 301 492-4148 E-Mail: ben.walker@ cms.hhs.gov
Unified Agenda
Title: Student Health Insurance Coverage (CMS-9981-F) Abstract: This rule establishes student health insurance coverage under the Public Health Service Act and the Affordable Care Act. The rule defines "student health insurance coverage" as a type of individual health insurance coverage, and exempts such coverage from certain requirements otherwise applicable to individual health insurance coverage. Priority: Other Significant Agenda Stage of Rulemaking: Final Rule Unfunded Mandates: No Major: No CFR Citation: 45 CFR 144; 45 CFR 147 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: PL 111-148 Legal Deadline: None Timetable:
Regulatory Flexibility Analysis Required: No Federalism: No Energy Affected: No Agency Contact: Gary Cohen Director, Oversight Group Department of Health and Human Services Centers for Medicare & Medicaid Services 7500 Security Boulevard Baltimore , MD 21244 Phone: 301 492-4117 E-Mail: gary.cohen@cms.hhs.gov
Title: Administrative Simplification: Adoption of Operating Rules for Electronic Funds Transfer (EFT) and Remittance Advice (RA) (CMS-0028-IFC) Abstract: This rule implements provisions of the Affordable Care Act of 2010 under Administrative Simplification that require the adoption of operating rules for Electronic Funds Transfer (EFT) and Remittance Advice, and to consideration of those operating rules developed by a qualified nonprofit entity that meets specific criteria. Agenda Stage of Rulemaking: Final Rule Priority: Other Significant Major: No Unfunded Mandates: Undetermined CFR Citation: Not Yet Determined (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: PL 111-148, sec 1104 Legal Deadline:
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Action Interim Final Rule
Unified Agenda
Date 06/00/2012
FR Cite
Regulatory Flexibility Analysis Required: Undetermined Government Levels Affected: Undetermined Federalism: Undetermined Energy Affected: No Agency Contact: Denise Buenning Director, Administrative Simplification Group, Office of E-Health Standards and Services, CMS Department of Health and Human Services Centers for Medicare & Medicaid Services Mail Stop S2-26-17 7500 Security Boulevard Baltimore , MD 21244 Phone: 410 786-6711 Extension: 66711 E-Mail: denise.buenning@cms.hhs.gov
Title: State Requirements for Exchange--Reinsurance and Risk Adjustments (CMS-9975-F) Abstract: This rule implements requirements for States related to reinsurance, risk corridors, and a permanent risk adjustment. The goals of these programs are to minimize negative impacts of adverse selection inside the Exchanges. Priority: Economically Significant Agenda Stage of Rulemaking: Final Rule Unfunded Mandates: No Major: Yes CFR Citation: 45 CFR 155, 156 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: PL 111-148, secs 1341 and 1342 Legal Deadline:
Regulatory Plan: Statement of Need: This rule finalizes guidelines for the transitional risk-sharing programs, reinsurance and risk corridors, as well as for the risk adjustment program that will continue beyond the first 3 years of Exchange operation. The purpose of these programs is to protect health insurance issuers from the negative effects of adverse selection and to protect consumers from increases in premiums due to uncertainty for issuers. Legal Basis: This rule implements the new Affordable Insurance Exchanges consistent with title I of the Affordable Care Act of 2010. Alternatives: None. This is a statutory requirement. Costs and Benefits: Payments through reinsurance, risk adjustment, and risk corridors reduce the increased risk of financial loss that health insurance issuers might otherwise expect to incur in 2014 due to market reforms such as guaranteed issue and the elimination of medical underwriting. These payments reduce the risk to the issuer and the issuer can pass on a reduced risk premium to enrollees. Administrative costs will vary across States and health insurance issuers depending on the sophistication of technical infrastructure and prior experience with data collection and risk adjustment. States and issuers that already have systems in place for data collection and reporting will have reduced administrative costs. Risks: If this regulation is not published, the Exchanges will not become operational by January 1, 2014, thereby violating the statute. Timetable:
Regulatory Flexibility Analysis Required: Undetermined

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Small Entities Affected: Governmental Jurisdictions Federalism: Yes Energy Affected: Undetermined Agency Contact: Alissa Deboy Health Insurance Specialist, Center for Consumer Information & Insurance Oversight Department of Health and Human Services Centers for Medicare & Medicaid Services 7500 Security Boulevard Baltimore , MD 21244 Phone: 301 492-4428 E-Mail: alissa.deboy1@cms.hhs.gov
Title: Inpatient Hospital Deductible and Hospital and Extended Care Services Coinsurance Amounts for CY 2013 (CMS-8046N) Abstract: This notice announces the inpatient hospital deductible and the hospital and extended care services coinsurance amounts for services furnished in calendar year 2013 under Medicare's Hospital Insurance program (Medicare Part A). The Medicare statute specifies the formulae used to determine these amounts. Agenda Stage of Rulemaking: Final Rule Priority: Other Significant Major: Undetermined Unfunded Mandates: No CFR Citation: None (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: 42 USC 1395e-2(b)(2); Social Security Act, sec 1813 (b)(2) Legal Deadline:
Timetable:
Regulatory Flexibility Analysis Required: No Government Levels Affected: No Small Entities Affected: No Federalism: No Energy Affected: No Agency Contact: Clare McFarland Deputy Director, Medicare and Medicaid Cost Estimates Group Department of Health and Human Services Centers for Medicare & Medicaid Services Office of the Actuary 7500 Security Boulevard N3-26-00 Baltimore , MD 21244 Phone: 410 786-6390 E-Mail: clare.mcfarland@cms.hhs.gov
Title: Part A Premiums for CY 2013 for the Uninsured Aged and for Certain Disabled Individuals Who Have Exhausted Other Entitlement (CMS-8047-N) Abstract: This notice announces the Hospital Insurance premium for calendar year 2013 under Medicare's Hospital Insurance program (Medicare Part A) for the uninsured aged and for certain disabled individuals who have exhausted other entitlement. Priority: Other Significant Major: Undetermined Agenda Stage of Rulemaking: Final Rule Unfunded Mandates: No
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CFR Citation: None (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: 42 USC 1395i-2(d)(2); 42 USC 1395i-2a(d)(2); Social Security Act, sec 1818(d)(2); Social Security Act, sec 1818A(d)(2) Legal Deadline:
Timetable:
Regulatory Flexibility Analysis Required: No Government Levels Affected: No Federalism: No Small Entities Affected: No Energy Affected: No Agency Contact: Clare McFarland Deputy Director, Medicare and Medicaid Cost Estimates Group Department of Health and Human Services Centers for Medicare & Medicaid Services Office of the Actuary 7500 Security Boulevard N3-26-00 Baltimore , MD 21244 Phone: 410 786-6390 E-Mail: clare.mcfarland@cms.hhs.gov
Title: Part B Monthly Actuarial Rates, Monthly Premium Rates, and Annual Deductible Beginning January 1, 2013 (CMS-8048N) Abstract: This notice announces the monthly actuarial rates for aged (age 65 and over) and disabled (under age 65) enrollees in Part B of Medicare for CY 2013. It also announces the monthly Part B premiums and the Part B deductible during CY 2013. Priority: Other Significant Agenda Stage of Rulemaking: Final Rule Major: Undetermined Unfunded Mandates: No CFR Citation: None (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: 42 USC 1395r; Social Security Act, sec 1839; MMA, sec 629; MMA, sec 811; DRA, sec 5111 Legal Deadline:
Timetable:
Regulatory Flexibility Analysis Required: No Government Levels Affected: No Small Entities Affected: No Federalism: No Energy Affected: No Agency Contact: Suzanne Codespote Deputy Director, Medicare and Medicaid Cost Estimates Group Department of Health and Human Services Centers for Medicare & Medicaid Services Office of the Actuary 7500 Security Boulevard Mail Stop N3-26-00 Baltimore , MD 21244 Phone: 410 786-7737 E-Mail: suzanne.codespote@ cms.hhs.gov
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Title: Medicare Shared Savings Program; Final Waivers (CMS-1439-IFC) Abstract: This interim final rule establishes waivers of the application of the Physician Self-Referral Law, the Federal antikickback statute, and certain civil monetary penalties (CMP) law provisions to specified financial arrangements involving accountable care organizations (ACOs) under the Medicare Shared Savings Program. The Affordable Care Act authorizes the Secretary to waive certain fraud and abuse laws as necessary to carry out the provisions of section 1899 of the Act (the Medicare Shared Savings Program). Priority: Other Significant Agenda Stage of Rulemaking: Final Rule Unfunded Mandates: No Major: No CFR Citation: Not Yet Determined (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: PL 111-148 sec 3022 Legal Deadline:
Timetable:
Action Interim Final Rule Interim Final Rule Comment Period End Date 11/02/2011 01/01/2012 FR Cite 76 FR 67992
Regulatory Flexibility Analysis Required: Undetermined Small Entities Affected: Organizations Agency Contact: Troy Barsky Director, Division of Technical Payment Policy Department of Health and Human Services Centers for Medicare & Medicaid Services Mail Stop C4-25-05 7500 Security Boulevard Baltimore , MD 21244 Phone: 410 786-8873 E-Mail: troy.barsky@cms.hhs.gov
Title: Requirements for Long-Term Care Facilities: Hospice Services (CMS-3140-F) Abstract: This rule establishes requirements that in order to participate in the Medicare and Medicaid programs, long-term care facilities must have an agreement with hospice agencies when hospice care is provided in a long-term care facility. Priority: Other Significant Agenda Stage of Rulemaking: Long-term Action Major: No Unfunded Mandates: No CFR Citation: 42 CFR 483 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: 42 USC 1302; 42 USC 1395hh Legal Deadline:
Action Other Source Statutory MMA sec 902 Description Date 10/22/2013
Timetable:
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Federalism: No Energy Affected: No Agency Contact: Kadie Thomas Health Insurance Specialist Department of Health and Human Services Centers for Medicare & Medicaid Services Office of Clinical Standards and Quality Mail Stop S3-02-01 7500 Security Boulevard Baltimore , MD 21244 Phone: 410 786-0468 E-Mail: kadie.thomas@cms.hhs.gov Agency Contact: Diane Corning Health Insurance Specialist Department of Health and Human Services Centers for Medicare & Medicaid Services Office of Clinical Standards and Quality Mail Stop S3-02-01 7500 Security Boulevard Baltimore , MD 21244 Phone: 410 786-8486 E-Mail: diane.corning@cms.hhs.gov
Title: Conditions of Participation (CoPs) for Community Mental Health Centers (CMHCs)(CMS-3202-F) Abstract: This rule establishes Conditions of Participation for community mental health centers (CMHCs) to ensure that CMHCs furnish services meeting essential health and safety standards. The rule focuses on patient-centered and outcomeoriented care and is based on four core requirements: 1) Patient's rights; 2) admission, assessment, and discharge; 3) treatment and coordination of services; and 4) governance. Agenda Stage of Rulemaking: Long-term Action Priority: Other Significant Major: No Unfunded Mandates: No CFR Citation: 42 CFR 485 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: sec 1102 42 USC 1302; sec 1861 42 USC 1395 hh Legal Deadline:
Timetable:
Regulatory Flexibility Analysis Required: No Government Levels Affected: No Small Entities Affected: Business Federalism: No Energy Affected: No Agency Contact: Mary Rossi-Coajou Health Insurance Specialist Department of Health and Human Services Centers for Medicare & Medicaid Services Office of Clinical Standards & Quality Mail Stop, S3-02-01 7500 Security Boulevard Baltimore , MD 21244 Phone: 410 786-6051 E-Mail: mary.rossicoajou@cms.hhs.gov
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Unified Agenda
View Related Documents Title: Home and Community Based Services Waivers (CMS-2296-F) Abstract: This rule revises the regulations implementing Medicaid home and community-based services (HCBS) waivers under section 1915(c) of the Social Security Act by providing States the option to combine the existing three waiver targeting groups. In addition, we are implementing other changes to the HCBS waiver provisions to convey expectations regarding personcentered plans of care, to provide characteristics of settings that are not home and community-based, to clarify the timing of amendments and public input requirements when States propose modifications to HCBS waiver programs and service rates, and to describe the additional strategies available to CMS to ensure State compliance with the statutory provisions of section 1915(c) of the Act. Priority: Other Significant Agenda Stage of Rulemaking: Long-term Action Unfunded Mandates: No Major: No CFR Citation: 42 CFR 441 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: 42 USC 1302 Legal Deadline: None Timetable:
Action Final Action ANPRM ANPRM Comment Period End NPRM NPRM Comment Period End Date 00/00/0000 06/22/2009 08/21/2009 04/15/2011 06/14/2011 76 FR 21311 74 FR 29453 FR Cite
Regulatory Flexibility Analysis Required: No Government Levels Affected: State Federalism: No Energy Affected: No Agency Contact: Kathy Poisal Health Insurance Specialist Department of Health and Human Services Centers for Medicare & Medicaid Services Centers for Medicaid State Operations Mail Stop S2-14-26 7500 Security Boulevard Baltimore , MD 21244 Phone: 410 786-5940 E-Mail: kathy.poisal@cms.hhs.gov
Title: Survey and Enforcement Requirements for Home Health Agencies (CMS-3256-P) Abstract: This proposed rule would establish requirements for unannounced, standard and extended surveys for home health agencies (HHAs), and provides a number of sanctions that may be imposed when HHAs are out of compliance with Federal requirements. This rule is necessary to implement changes in OBRA '87 in section 1891 of the Social Security Act. The rule would emphasize quality of care, health, and safety for patients receiving home health services. The goal is to move systems away from a simple test of compliance to one geared toward quality services provided to patients. Priority: Other Significant Agenda Stage of Rulemaking: Long-term Action Major: Undetermined Unfunded Mandates: Undetermined CFR Citation: 42 CFR 488 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: Omnibus Budget Reconciliation Act of 1987 (OBRA '87); PL 100-203 Legal Deadline: None Timetable:
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Regulatory Flexibility Analysis Required: No Federalism: No Energy Affected: No Agency Contact: Debora Terkay Health Insurance Specialist Department of Health and Human Services Centers for Medicare & Medicaid Services Mail Stop S2-02-38 7500 Security Boulevard Baltimore , MD 21244 Phone: 410 786-6835 E-Mail: debora.terkay@cms.hhs.gov

Unified Agenda
Title: Changes in Provider and Supplier Enrollment, Ordering and Referring, and Documentation Requirements; and Changes in Provider Agreements (CMS-6010-F) Abstract: This final rule implements several provisions set forth in the Affordable Care Act. Specifically, the rule requires providers and suppliers under the Medicare and Medicaid programs that qualify for a national provider identifier (NPI) to include their NPI on all applications to enroll in such programs and all claims for payment submitted under such programs. The rule also requires, that physician and nonphysician practitioners (NPP) who are eligible to order and refer services for Medicare beneficiaries be enrolled in Medicare and adds requirements for physicians to provide documentation on referrals to programs at high risk of waste and abuse. Priority: Other Significant Agenda Stage of Rulemaking: Long-term Action Major: No Unfunded Mandates: No CFR Citation: 42 CFR 424 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: 42 USC 1302 and 1395hh Legal Deadline:
Timetable:
Additional Information: Includes Retrospective Review under E.O. 13563. Regulatory Flexibility Analysis Required: No Government Levels Affected: No Federalism: No Agency Contact: John Spiegel Director, Medicare Program of Integrity Group Department of Health and Human Services Centers for Medicare & Medicaid Services Center for Program Integrity Mail Stop B3-01-14 7111 Security Boulevard Baltimore , MD 21244 Phone: 410 786-5704 FAX: 410 786-0035 E-Mail: john.spiegel@cms.hhs.gov

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Title: CLIA Programs and HIPAA Privacy Rule; Patients' Access to Laboratory Test Reports (CMS-2319-F) Abstract: This CMS-CDC-OCR rule amends the Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations to specify that, upon a patient's request, the laboratory may provide access to completed test reports that, using the laboratory's authentication process, can be identified as belonging to that patient. Subject to conforming amendments, the rule retains the existing provisions that provide for release of test reports to authorized persons and, if applicable, the individuals (or their personal representative) responsible for using the test reports and, in the case of reference laboratories, the laboratory that initially requested the test. In addition, this rule also amends the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule to provide individuals the right to receive their test reports directly from laboratories by removing the exceptions for CLIA-certified laboratories and CLIA-exempt laboratories from the provision that provides individuals with the right of access to their protected health information. Priority: Other Significant Agenda Stage of Rulemaking: Long-term Action Major: No Unfunded Mandates: No CFR Citation: 42 CFR 493; 45 CFR 164 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: 42 USC 263a Legal Deadline: None Timetable:
Action Final Action NPRM ANPRM Comment Period End Date 00/00/0000 09/14/2011 11/14/2011 76 FR 56712 FR Cite
Additional Information: Includes Retrospective Review under E.O. 13563. Regulatory Flexibility Analysis Required: Undetermined Government Levels Affected: State Small Entities Affected: Business; Governmental Jurisdictions Federalism: No Energy Affected: No Agency Contact: Judith Yost Director, Division of Laboratory Services Department of Health and Human Services Centers for Medicare & Medicaid Services 7500 Security Boulevard Baltimore , MD 21244-1850 Phone: 410 786-3531 E-Mail: judith.yost@cms.hhs.gov
Title: Revisions to Certain Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) Suppliers Safeguards (CMS-6036-F2) Abstract: This final rule would remove the definition of direct solicitation, allow DMEPOS suppliers to contact licensed agencts to provide DMEPOS supplies unless prohibited by state law, remove the requirement for compliance with local zoning laws, and modify certain state licensing requirement exceptions. Agenda Stage of Rulemaking: Long-term Action Priority: Other Significant Major: No Unfunded Mandates: No CFR Citation: 42 CFR 424.57 (c) (11) (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: Social Security Act, secs 1102 and 1871 Legal Deadline:
Timetable:
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Final Action

04/00/2014
Unified Agenda
Regulatory Flexibility Analysis Required: No Government Levels Affected: No Federalism: No Small Entities Affected: Business Related RINs: Related to 0938-AO90 Agency Contact: Frank Whelan Health Insurance Specialist Department of Health and Human Services Centers for Medicare & Medicaid Services Office of Financial Management Mailstop C3-02-16 7500 Security Boulevard Baltimore , MD 21244 Phone: 410 786-1302 E-Mail: frank.whelan@cms.hhs.gov
Title: Preventive Services Under the Affordable Care Act (CMS-9992-F) Abstract: The Affordable Care Act requires that a group health plan and a health insurance issuer offering group or individual health insurance coverage provide benefits for and prohibit the imposition of cost-sharing requirements with respect to certain recommended evidence-based items or services. This rule finalizes the requirements and responds to any comments as the result of the interim final rule implementing this provision. Agenda Stage of Rulemaking: Long-term Action Priority: Other Significant Major: No Unfunded Mandates: No CFR Citation: 45 CFR 156 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: PL 111-148 Legal Deadline: None Timetable:
Action Next Action Undetermined Interim Final Rule Interim Final Rule Comment Period End 2nd Interim Final Rule 2nd Interim Final Rule Comment Period End 07/19/2010 09/10/2010 08/03/2011 09/30/2011 76 FR 46621 75 FR 41726 Date FR Cite
Regulatory Flexibility Analysis Required: No Small Entities Affected: Business Energy Affected: No Related Agencies: Joint : DOL; Joint : TREAS Agency Contact: James Mayhew Health Insurance Specialist Department of Health and Human Services Centers for Medicare & Medicaid Services 7500 Security Boulevard Baltimore , MD 21244 Phone: 301 492-4113 E-Mail: james.mayhew@cms.hhs.gov
Title: Skilled Nursing Facility Required Disclosure of Ownership (CMS-6008-F)

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Abstract: This final rule will establish the requirements for disclosure of skilled nursing facilities' ownership and other disclosable parties. These requirements were initially proposed in the Skilled Nursing Facilities for FY 2012 proposed rule published on May 6, 2011. Priority: Other Significant Agenda Stage of Rulemaking: Long-term Action Unfunded Mandates: No Major: No CFR Citation: 42 CFR 424.502; 42 CFR 424.516; 42 CFR 455.101; 42 CFR 455.104 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: PL 111-148, sec 6101 Legal Deadline:
Action Other Source Statutory Description ACA Sec 6101 requires the promulgation of a regulation within two years after the ACA Date 03/23/2012
Timetable:
Regulatory Flexibility Analysis Required: No Government Levels Affected: State Small Entities Affected: Business; Governmental Jurisdictions Federalism: No Related RINs: Split From 0938-AQ29 Agency Contact: Sandra Bastinelli Health Insurance Specialist Department of Health and Human Services Centers for Medicare & Medicaid Services Mailstop B3-01-14 7500 Security Boulevard Baltimore , MD 21244 Phone: 410 786-3630 E-Mail: sandra.bastinelli@cms.hhs.gov
RIN: 0938-AJ17 View Related Documents
Title: Medicare Changes in Conditions of Participation Requirements and Payment Provisions for Rural Health Clinics and Federally Qualified Health Centers (CMS-1910-F2) Abstract: This rule finalizes the provisions of the proposed rule published on June 27, 2008, which reissued provisions of the final rule that was published on December 24, 2003, but was subsequently suspended. This final rule amends the Medicare certification requirements for rural health clinics (RHCs), as required by section 4205 of the Balanced Budget Act of 1997. It updates the regulations pertaining to RHC staffing requirements, allows RHCs to contract with RHC nonphysician providers, and revises the RHC and Federally Qualified Health Center (FQHC) payment methodology. Priority: Other Significant Agenda Stage of Rulemaking: Completed Action Unfunded Mandates: No Major: No CFR Citation: 42 CFR 405; 42 CFR 491 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: 42 USC 1302; 42 USC 1395hh; Deficit Reduction Act of 2005 (PL 109-171), sec 6083 Legal Deadline:
Action Other Source Statutory MMA Section 902 Description Date 06/27/2011
Timetable:
Action NPRM NPRM Comment Period End Final Rule Interim Final Rule Interim Final Rule Comment Period End Second NPRM Second NPRM Comment Period End Date 02/28/2000 04/28/2000 12/24/2003 09/22/2006 11/21/2006 06/27/2008 08/26/2008 73 FR 36463 68 FR 74791 71 FR 55341 FR Cite 65 FR 10450
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Withdrawn

06/27/2011
Unified Agenda
Regulatory Flexibility Analysis Required: No Government Levels Affected: Federal Federalism: No Small Entities Affected: Business Energy Affected: No Agency Contact: John Warren Health Insurance Specialist Department of Health and Human Services Centers for Medicare & Medicaid Services Centers for Medicare Management Mail Stop C4-01-15 7500 Security Boulevard Baltimore , MD 21244 Phone: 410 786-3633 E-Mail: john.warren@cms.hhs.gov
RIN: 0938-AJ96 View Related Documents
Title: Use of Restraints and Seclusion in Residential Treatment Facilities Providing Inpatient Psychiatric Services to Individuals Under Age 21 (CMS-2065-F) Abstract: This final rule addresses standards of practice that residential treatment facilities providing inpatient psychiatric services for individuals under age 21 must meet with regard to the use of restraints (including psychoactive drugs) and seclusion. Agenda Stage of Rulemaking: Completed Action Priority: Other Significant Major: No Unfunded Mandates: No CFR Citation: 42 CFR 441 and 442; 42 CFR 483 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: 42 USC 1302; 42 USC 1396d Legal Deadline: None Timetable:
Action Interim Final Rule Interim Final Rule Effective Interim Final Rule Comment Period End 60 -Day Delay of Effective Date to 05/22/2001 Interim Final Rule Amendment With Clarification Interim Final Rule Comment Period End Withdrawn Date 01/22/2001 03/23/2001 03/23/2001 03/21/2001 05/22/2001 07/23/2001 10/24/2011 66 FR 15800 66 FR 28110 FR Cite 66 FR 7148
Regulatory Flexibility Analysis Required: No Government Levels Affected: No Small Entities Affected: Business Federalism: No Energy Affected: No Agency Contact: Thomas Shenk Health Insurance Specialist Department of Health and Human Services Centers for Medicare & Medicaid Services Division of Benefits and Coverage Policy Mail Stop S2-14-26 7500 Security Boulevard Baltimore , MD 21244 Phone: 410 786-3295 E-Mail: thomas.shenk@cms.hhs.gov
Title: Medical Improvement Eligibility Group and Definition of Work (CMS-2143-P) 135
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Abstract: This proposed rule would codify in regulations certain statutory provisions established under the Balanced Budget Act of 1997 and the Ticket to Work and Work Incentives Improvement Act of 1999 (TWWIIA). These statutory provisions allow States to provide Medicaid coverage to employed individuals with disabilities who, due to improvement in medical conditions, lose eligibility for disability benefits that confer Medicaid eligibility. This proposed rule would also provide a definition for "severe medically determinable impairment" under the TWWIIA. Priority: Other Significant Agenda Stage of Rulemaking: Completed Action Unfunded Mandates: No Major: No CFR Citation: 42 CFR 435 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: PL 105-33, sec 4733 Balanced Budget Act of 1997; PL 106-170, sec 201 Ticket to Work and Work Incentives Improvement Act of 1999 Legal Deadline: None Timetable:
Regulatory Flexibility Analysis Required: No Government Levels Affected: State Small Entities Affected: No Federalism: No Energy Affected: No Agency Contact: Joseph Razes Technical Director, Disabled and Elderly Health Program Group Div. of Advocacy and Special Issues Department of Health and Human Services Centers for Medicare & Medicaid Services Center for Medicaid and State Operations Mail Stop, S2-14-26 7500 Security Boulevard Baltimore , MD 21244 Phone: 410 786-6126 FAX: 410 786-9004 E-Mail: joseph.razes@cms.hhs.gov
Title: Optional State Plan Case Management Services (CMS-2237-F) Abstract: This final rule revises current Medicaid regulations to incorporate changes made by the Deficit Reduction Act of 2005. The rule finalizes portions of the interim final rule published on December 4, 2007, that were not rescinded under the Congressional moratoria. The rule clarifies what is reimbursable under the Medicaid case management and targeted case management benefit and is intended to offer guidance to States on implementing the DRA provisions. Agenda Stage of Rulemaking: Completed Action Priority: Economically Significant Major: Yes Unfunded Mandates: No CFR Citation: 42 CFR 431; 42 CFR 440; 42 CFR 441 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: Deficit Reduction Act of 2005; PL 109-171, sec 6052 Legal Deadline: Public Law 110-28 established a 1-year moratorium on rule until May 25, 2008. Public Law 110-252 extended the moratorium to March 31, 2009. Public Law 111-5 extended moratorium to June 30, 2009.
Timetable:
Action Interim Final Rule Interim Final Rule Comment Period End Interim Final Rule Effective Withdrawn Date 12/04/2007 02/04/2008 03/03/2008 10/24/2011 FR Cite 72 FR 68077
Regulatory Flexibility Analysis Required: Undetermined Small Entities Affected: Governmental Jurisdictions

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Energy Affected: No Agency Contact: Jean Close Health Insurance Specialist Department of Health and Human Services Centers for Medicare & Medicaid Services Mail Stop S2-14-26 7500 Security Boulevard Baltimore , MD 21244 Phone: 410 786-2804 E-Mail: jean.close@cms.hhs.gov
Unified Agenda
Title: Standards for E-Prescribing Under Medicare Part D and the Lifting of the Long Term Care Exemption (CMS-0023-P) Abstract: On July 1, 2010, an interim final rule was published that permitted the voluntary use of National Council for Prescription Drug Programs (NCPDP) SCRIPT 10.6 for conducting certain e-prescribing transactions for the Medicare Part D electronic prescription drug program under section 1860D 4(e) of the Social Security Act. As recommended by industry stakeholders, this proposed rule would request comment on adopting newer versions of the eRx standard for use in eprescribing for Medicare Part D. It also proposes to lift the long term care exemption for e-prescribing. Priority: Substantive, Nonsignificant Agenda Stage of Rulemaking: Completed Action Major: No Unfunded Mandates: No CFR Citation: 42 CFR 423 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: 42 USC 1395 Legal Deadline: None Timetable:
Action Interim Final Rule Interim Final Rule Comment Period End Merged With 0938 -AR11 Date 07/01/2010 08/30/2010 10/24/2011 FR Cite 75 FR 38026
Regulatory Flexibility Analysis Required: No Government Levels Affected: No Small Entities Affected: No Federalism: No Energy Affected: No Agency Contact: Andrew Morgan Health Insurance Specialist Department of Health and Human Services Centers for Medicare & Medicaid Services Office of E- Standards & Services Mail Stop, S2-26-17 7500 Security Boulevard Baltimore , MD 21244 Phone: 410 786-2543 FAX: 410-786-1847 E-Mail: andrew.morgan@cms.hhs.gov
Title: Limited Changes to the Competitive Acquisition of Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS)(CMS-1561-F) Abstract: This final rule, as mandated by section 154 of the Medicare Improvements for Patients and Providers Act (MIPPA), requires the temporary delay of Round 1 of the DMEPOS Competitive Bidding Program. As such, a new competition excluding certain services will be necessary. Section 154 also requires the program to provide a process for giving suppliers feedback on missing financial documents and mandates the disclosure of subcontractors under a competitive bidding program.
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Priority: Other Significant Agenda Stage of Rulemaking: Completed Action Major: No Unfunded Mandates: No CFR Citation: 42 CFR 414 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: 42 USC 1302; 42 USC 1395hh; 42 USC 1395rr(b)(1) Legal Deadline:
Action Other Source Statutory MMA section 902 Description Date 01/16/2012
Timetable:
Action Interim Final Rule Interim Final Rule Comment Period End Merged With 0938 -AQ27 Date 01/16/2009 03/17/2009 07/07/2011 FR Cite 74 FR 2873
Regulatory Flexibility Analysis Required: No Federalism: No Agency Contact: Lorrie Ballantine Technical Advisor Department of Health and Human Services Centers for Medicare & Medicaid Services Mail Stop C5-08-17 7500 Security Boulevard Baltimore , MD 21244 Phone: 410 786-4499 E-Mail: lorrie.ballantine@cms.hhs.gov
Title: Implementing Regulations for Reauthorization of the Children's Health Insurance Program (CHIP) (CMS-2301-P) Abstract: This proposed rule would introduce several new features as a result of the passage of the Children's Health Insurance Program Reauthorization Act (CHIPRA) including a CHIP performance bonus payment system through 2013. For example, the rule would define and provide more guidance on the parameters of the new Express Lane Eligibility option for States including what it means to be an Express Lane agency. It would also define the parameters for the new state option to cover pregnant women in CHIP and provide further guidance regarding the newly required dental benefit package. In addition, it would codify the definition of individuals who are lawfully residing in the US but who are not citizens who can be enrolled in Medicaid and CHIP. Under section 2102 of the Affordable Care Act, this rule would also make technical corrections to selected provisions in CHIPRA and the American Recovery and Reinvestment Act of 2009 (ARRA). Priority: Economically Significant Agenda Stage of Rulemaking: Completed Action Unfunded Mandates: Undetermined Major: Undetermined CFR Citation: Not Yet Determined (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: CHIPRA of 2009 (PL 111-3); PL 111-148, sec 2102 Legal Deadline: None Timetable:
Action Merged With 0938 -AR04 Date 12/31/2011 FR Cite
Additional Information: Includes Retrospective Review under E.O. 13563. Regulatory Flexibility Analysis Required: Undetermined Federalism: Undetermined Energy Affected: Undetermined Related RINs: Related to 0938-AP54 Agency Contact: Linda Nablo Health Insurance Specialist Department of Health and Human Services Government Levels Affected: State
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Centers for Medicare & Medicaid Services 7500 Security Boulevard Baltimore , MD 21244 Phone: 410 786-5143 E-Mail: linda.nablo@cms.hhs.gov
Unified Agenda
Title: Children's Health Insurance Program (CHIP) Child Enrollment Contingency Fund Payments (CMS-2488-P) Abstract: This proposed rule would establish the "CHIP contingency fund" to eliminate State shortfalls in funding beginning in FY 2009. A State may qualify for the contingency funds if it projects a funding shortfall for the fiscal year (not counting any redistributed amounts they may receive) and its average monthly child enrollment exceeds its target average number of enrollees for the fiscal year. Contingency payments equal a State's projected per capita Federal spending multiplied by the excess amount. This proposed rule implements provisions of the Children's Health Insurance Program Reauthorization Act of 2009. Agenda Stage of Rulemaking: Completed Action Priority: Other Significant Major: Undetermined Unfunded Mandates: Undetermined CFR Citation: Not Yet Determined (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: Children's Health Insurance Program Reauthorization Act of 2009 (PL 111-3) Legal Deadline: None Timetable:
Regulatory Flexibility Analysis Required: Undetermined Federalism: Undetermined Energy Affected: No Agency Contact: Richard Strauss Health Insurance Specialist Department of Health and Human Services Centers for Medicare & Medicaid Services Mail Stop S3-13-15 7500 Security Boulevard Baltimore , MD 21244 Phone: 410 786-2019 E-Mail: richard.strauss@cms.hhs.gov
Title: Ambulatory Surgical Centers Conditions for Coverage: Same-Day Services (CMS-3217-F) Abstract: This rule amends and clarifies several requirements from the November 18, 2008, Outpatient Prospective Payment System final rule. Medicare beneficiaries may be medically disadvantaged by certain requirements in the patient rights condition. Specifically, the patient rights condition requires that Ambulatory Surgical Centers (ASCs) furnish certain information to patients in advance of the date of the procedure. Those ASCs who routinely perform same-day procedures will be unable to provide this information prior to the date of surgery and will be out of compliance with the regulation. Therefore, patients will be denied same-day procedures in an ASC because of current regulatory requirements. Priority: Other Significant Agenda Stage of Rulemaking: Completed Action Unfunded Mandates: No Major: No CFR Citation: 42 CFR 416 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: Social Security Act sec 1832(a)(2)(F)(i)
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Legal Deadline:
Action Other Source Statutory MMA sec 902
Unified Agenda
Description
Date 04/23/2010
Timetable:
Additional Information: Includes Retrospective Review under E.O. 13563. Regulatory Flexibility Analysis Required: No Small Entities Affected: Business Energy Affected: No Agency Contact: Joan Moliki Health Insurance Specialist Department of Health and Human Services Centers for Medicare & Medicaid Services Mail Stop S3-02-01 7500 Security Boulevard Baltimore , MD 21244 Phone: 410 786-5526 E-Mail: joan.moliki@cms.hhs.gov Government Levels Affected: No Federalism: No
Title: Charges for Vaccine Administration Under the Vaccines for Children (VFC) Program (CMS-2310-NC) Abstract: This notice with comment period updates the interim regional maximum fees that providers may charge for the administration of pediatric vaccines to Federally vaccine-eligible children under the Pediatric Immunization Distribution Program, more commonly known as the Vaccines for Children (VFC) program. These administration fees are intended to be used on an interim basis until a final notice or new regulation is issued that revises the maximum regional charges. Agenda Stage of Rulemaking: Completed Action Priority: Other Significant Major: No Unfunded Mandates: No CFR Citation: Not Yet Determined (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: Omnibus Budget Reconciliation Act of 1993 (PL 103-66) Legal Deadline: None Timetable:
Action Merged With 0938 -AQ63 Date 12/01/2011 FR Cite
Regulatory Flexibility Analysis Required: No Small Entities Affected: No Energy Affected: No Agency Contact: Mary Beth Hance Senior Policy Advisor Department of Health and Human Services Centers for Medicare & Medicaid Services Mail Stop S2-26-12 7500 Security Boulevard Baltimore , MD 21224 Phone: 410 786-4299 E-Mail: marybeth.hance@cms.hhs.gov
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Centers for Medicare & Medicaid Services ( CMS )
Title: Health Care-Related Taxes--Clarification of Definition (CMS-2314-P) Abstract: This proposed rule would clarify existing regulatory text pertaining to the definition of a health care related tax in order to ensure compliance with the statutory requirements governing what is considered a health care related tax. Agenda Stage of Rulemaking: Completed Action Priority: Other Significant Major: No Unfunded Mandates: No CFR Citation: 42 CFR 433 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: 42 USC 1396 (a) and (b) Legal Deadline: None Timetable:
Regulatory Flexibility Analysis Required: No Small Entities Affected: No Energy Affected: No Agency Contact: Kristin Fan Deputy Director, Financial Management Group Department of Health and Human Services Centers for Medicare & Medicaid Services Mail Stop S3-13-23 7500 Security Boulevard Baltimore , MD 21244 Phone: 410 786-4581 E-Mail: kristin.fan@cms.hhs.gov
Title: Changes Affecting Hospital and Critical Access Hospital (CAH) Conditions of Participation (CoPs): Credentialing and Privileging of Telemedicine Physicians and Practitioners (CMS-3227-F) Abstract: This rule revises the conditions of participation (CoPs) for both hospitals and critical access hospitals (CAHs). These revisions allow for a new credentialing and privileging process for physicians and practitioners providing telemedicine services. Priority: Other Significant Agenda Stage of Rulemaking: Completed Action Major: No Unfunded Mandates: No CFR Citation: 42 CFR 482; 42 CFR 485 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: 42 USC 1302; 42 USC 1395hh and 1395rr Legal Deadline: None Timetable:
Additional Information: Includes Retrospective Review under E.O. 13563. Regulatory Flexibility Analysis Required: No Small Entities Affected: Business Agency Contact: CDR Scott Cooper Health Insurance Specialist Department of Health and Human Services Centers for Medicare & Medicaid Services Government Levels Affected: No Federalism: No
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Clinical Standards Group Mail Stop S3-05-15 7500 Security Boulevard Baltimore , MD 21244 Phone: 410 786-9465 E-Mail: scott.cooper@cms.hhs.gov Agency Contact: Jeannie Miller Director, Clinical Standards Group, Department of Health and Human Services Centers for Medicare & Medicaid Services Mail Stop S3-05-15 7500 Security Boulevard Baltimore , MD 21244 Phone: 410 786-3164 E-Mail: jeannie.miller@cms.hhs.gov
Title: Long-Term Care Facility Quality Assessment and Performance Improvement Dementia Management and Abuse Prevention Training (CMS-3231-P) Abstract: This proposed rule would implement section 6102 of the Affordable Care Act by amending the requirements that an institution must meet to participate as a skilled nursing facility (SNF) in the Medicare program, or a nursing facility (NF) in the Medicaid program. This proposed rule would require these long term care (LTC) facilities to develop, implement, and maintain a quality assessment and performance improvement (QAPI) program. In addition, this proposed rule would also amend the requirements that an institution must meet in order to qualify to participate as a SNF in the Medicare program, or as a NF in the Medicaid program, by requiring the current mandatory on-going training requirements for nurse aides (NA) to include dementia management and resident abuse training. This proposed rule would also clarify that the definition of NA includes an individual who provides services through an agency or under contract with a SNF or NF. Finally, this proposed rule would address section 6121 of the Affordable Care Act which requires facilities to include dementia management and abuse prevention training as part of pre-employment initial training for permanent and contract or agency staff, and if the Secretary determines appropriate, as part of ongoing in-service training. Priority: Other Significant Agenda Stage of Rulemaking: Completed Action Unfunded Mandates: No Major: No CFR Citation: 42 CFR 483 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: PL 111-148, secs 6102; 6121; 42 USC 1320a-7j Legal Deadline: None Timetable:
Regulatory Flexibility Analysis Required: No Government Levels Affected: No Small Entities Affected: Business Federalism: No Energy Affected: No Agency Contact: Kadie Thomas Health Insurance Specialist Department of Health and Human Services Centers for Medicare & Medicaid Services Office of Clinical Standards and Quality Mail Stop S3-02-01 7500 Security Boulevard Baltimore , MD 21244 Phone: 410 786-0468 E-Mail: kadie.thomas@cms.hhs.gov Agency Contact: Diane Corning Health Insurance Specialist Department of Health and Human Services Centers for Medicare & Medicaid Services Office of Clinical Standards and Quality Mail Stop S3-02-01 7500 Security Boulevard Baltimore , MD 21244 Phone: 410 786-8486 E-Mail: diane.corning@cms.hhs.gov 142
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Title: Administrative Simplification: Adoption of Authoring Organizations for Operating Rules and Adoption of Operating Rules for Eligibility and Claims Status (CMS-0032-F) Abstract: This rule implements provisions of the Affordable Care Act of 2010 under Administrative Simplification that require the adoption of authoring organizations for operating rules and the adoption of operating rules for eligibility and claims status, and to consider those operating rules developed by a qualified nonprofit entity that meets specific criteria. Agenda Stage of Rulemaking: Completed Action Priority: Economically Significant Major: Yes Unfunded Mandates: Private Sector CFR Citation: 45 CFR 160; 45 CFR 162 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: PL 111-148, sec 1104 Legal Deadline:
Timetable:
Action Interim Final Rule Interim Final Rule Comment Period End Withdrawn Date 07/08/2011 09/06/2011 10/24/2011 FR Cite 76 FR 40458
Regulatory Flexibility Analysis Required: Undetermined Small Entities Affected: Organizations Energy Affected: No Agency Contact: Lorraine Doo Deputy Director, Office of E-Health Systems and Services Department of Health and Human Services Centers for Medicare & Medicaid Services Mail Stop S2-26-17 7500 Security Boulevard Baltimore , MD 21244 Phone: 410 786-6597 E-Mail: lorraine.doo@cms.hhs.gov
Title: Inpatient Hospital Deductible and Hospital and Extended Care Services Coinsurance Amounts for CY 2012 (CMS-8043N) Abstract: This notice announces the inpatient hospital deductible and the hospital and extended care services coinsurance amounts for services furnished in calendar year 2012 under Medicare's Hospital Insurance program (Medicare Part A). The Medicare statute specifies the formulae used to determine these amounts. Agenda Stage of Rulemaking: Completed Action Priority: Economically Significant Major: Yes Unfunded Mandates: No CFR Citation: None (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: 42 USC 1395e-2(b)(2); Social Security Act, sec 1813 (b)(2) Legal Deadline:
Timetable:
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Action Final Action

Date 11/01/2011 FR Cite 76 FR 67568
Unified Agenda
Regulatory Flexibility Analysis Required: No Government Levels Affected: No Federalism: No Small Entities Affected: No Energy Affected: No Agency Contact: Clare McFarland Deputy Director, Medicare and Medicaid Cost Estimates Group Department of Health and Human Services Centers for Medicare & Medicaid Services Office of the Actuary Mail Stop N3-26-00 7500 Security Boulevard Baltimore , MD 21244 Phone: 410 786-6390 E-Mail: clare.mcfarland@cms.hhs.gov
Title: Part A Premiums for CY 2012 for the Uninsured Aged and for Certain Disabled Individuals Who Have Exhausted Other Entitlement (CMS-8044-N) Abstract: This notice announces the premium for calendar year 2012 under Medicare's Hospital Insurance program (Medicare Part A) for the uninsured aged and for certain disabled individuals who have exhausted other entitlement. Priority: Other Significant Agenda Stage of Rulemaking: Completed Action Major: No Unfunded Mandates: No CFR Citation: None (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: 42 USC 1395i-2(d)(2); 42 USC 1395i-2a(d)(2); Social Security Act, sec 1818(d)(2); Social Security Act, sec 1818A(d)(2) Legal Deadline:
Timetable:
Action Final Action Date 11/01/2011 FR Cite 76 FR 67570
Regulatory Flexibility Analysis Required: No Government Levels Affected: No Small Entities Affected: No Federalism: No Energy Affected: No Agency Contact: Clare McFarland Deputy Director, Medicare and Medicaid Cost Estimates Group Department of Health and Human Services Centers for Medicare & Medicaid Services Office of the Actuary 7500 Security Boulevard Mail Stop N3-26-00 Baltimore , MD 21244 Phone: 410 786-6390 E-Mail: clare.mcfarland@cms.hhs.gov
Title: Part B Monthly Actuarial Rates, Monthly Premium Rates, and Annual Deductible Beginning January 1, 2012 (CMS-8045N) Abstract: This notice announces the monthly actuarial rates for aged (age 65 and over) and disabled (under age 65) enrollees
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in Part B of Medicare for CY 2012. It also announces the monthly Part B premiums and the Part B deductible during CY 2012. Priority: Economically Significant Agenda Stage of Rulemaking: Completed Action Unfunded Mandates: No Major: Yes CFR Citation: None (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: 42 USC 1395r; Social Security Act, sec 1839; MMA, sec 629; MMA, sec 811; DRA, sec 5111 Legal Deadline:
Timetable:
Regulatory Flexibility Analysis Required: No Government Levels Affected: No Federalism: No Small Entities Affected: No Energy Affected: No Agency Contact: Suzanne Codespote Deputy Director, Medicare and Medicaid Cost Estimates Group Department of Health and Human Services Centers for Medicare & Medicaid Services Office of the Actuary 7500 Security Boulevard Mail Stop N3-26-00 Baltimore , MD 21244 Phone: 410 786-7737 E-Mail: suzanne.codespote@ cms.hhs.gov
Title: Availability of Medicare Data for Performance Measurement (CMS-5059-F) Abstract: Under the Affordable Care Act of 2010, this rule authorizes the release and use of standardized extracts of Medicare claims data to measure the performance of providers and suppliers in ways that protect patient privacy and in accordance with other requirements. Priority: Other Significant Agenda Stage of Rulemaking: Completed Action Major: No Unfunded Mandates: No CFR Citation: None (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: PL 111-148, sec 10332 Legal Deadline:
Timetable:
Regulatory Flexibility Analysis Required: No Small Entities Affected: Business Energy Affected: No Agency Contact: Colleen Bruce Health Insurance Specialist Department of Health and Human Services Centers for Medicare & Medicaid Services 7500 Security Boulevard Mail Stop, C5-19-16 Baltimore , MD 21244
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Phone: 410 786-5529 E-Mail: colleen.bruce@cms.hhs.gov
Unified Agenda
Title: Medicaid Recovery Audit Contractors (CMS-6034-F) Abstract: This final rule would provide guidance to States related to Federal/State funding of State start-up, operation and maintenance costs of Medicaid Recovery Audit Contractors (Medicaid RACs), and the payment methodology for State payments to Medicaid RACs in accordance with section 6411 of the Affordable Care Act. In addition, this rule includes requirements for States to assure that adequate appeals processes are in place for providers to dispute adverse determinations made by Medicaid RACs. Finally, the rule requires States and Medicaid RACs coordinate efforts with existing contractors and entities auditing Medicaid providers and with State and Federal law enforcement agencies. Agenda Stage of Rulemaking: Completed Action Priority: Economically Significant Major: Yes Unfunded Mandates: No CFR Citation: 42 CFR 455 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: PL 111-148, sec 6411; PL 111-152 Legal Deadline:
Timetable:
Regulatory Flexibility Analysis Required: No Government Levels Affected: State Small Entities Affected: Business; Governmental Jurisdictions Federalism: Yes Energy Affected: No Agency Contact: Joanne Davis Health Insurance Specialist Department of Health and Human Services Centers for Medicare & Medicaid Services Mail Stop B2-15-24 7500 Security Boulevard Baltimore , MD 21244 Phone: 410 786-5127 FAX: 410 786-0711 E-Mail: joanne.davis@cms.hhs.gov
Title: Durable Medical Equipment (DME) Face to Face Encounters and Written Orders Prior to Delivery (CMS-6033-P) Abstract: This proposed rule would implement section 1834(a)(11)(B) of the Social Security Act, which was recently amended by the Affordable Care Act. It would establish a face-to-face encounter as a condition of payment for certain durable medical equipment (DME). When this face-to-face encounter is performed by a physician assistant, a nurse practitioner or a clinical nurse specialist, a physician must document that the face-to-face has occurred pursuant to the order being written. The complete list of covered items of DME that require a face-to-face encounter will be published annually in the Federal Register. Priority: Economically Significant Agenda Stage of Rulemaking: Completed Action Unfunded Mandates: No Major: Yes CFR Citation: 42 CFR 410 (To search for a specific CFR, visit the Code of Federal Regulations )
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Legal Authority: PL 111-148, sec 6407 Legal Deadline:
Unified Agenda
Description
Date 01/01/2010
Timetable:
Additional Information: Includes Retrospective Review under E.O. 13563. Regulatory Flexibility Analysis Required: No Government Levels Affected: No Federalism: No Small Entities Affected: Business Energy Affected: No Agency Contact: Latesha Walker III Supervisory Health Insurance Specialist Department of Health and Human Services Centers for Medicare & Medicaid Services Office of Financial Management Mail Stop C3-07-08 7500 Security Boulevard Baltimore , MD 21244 Phone: 410 786-1101 E-Mail: latesha.walker@cms.hhs.gov
Title: Medicare Shared Savings Program: Accountable Care Organizations (CMS-1345-F) Abstract: This rule implements section 3022 of the Affordable Care Act relating to Medicare payments to providers of services and suppliers participating in Accountable Care Organizations (ACOs). Under this provision, providers of services and suppliers can continue to receive traditional Medicare fee-for-service payments under Parts A and B, and be eligible for additional payments based on meeting specified quality and savings requirements. Agenda Stage of Rulemaking: Completed Action Priority: Economically Significant Major: Yes Unfunded Mandates: No CFR Citation: 42 CFR 425 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: PL 111-148, sec 3022 Legal Deadline:
Timetable:
Action Notice NPRM NPRM Comment Period End Final Action Date 11/17/2010 04/07/2011 06/06/2011 11/02/2011 76 FR 67802 FR Cite 75 FR 70165 76 FR 19527
Regulatory Flexibility Analysis Required: No Small Entities Affected: Organizations Energy Affected: No Agency Contact: Terri Postma Health Insurance Specialist Department of Health and Human Services Centers for Medicare & Medicaid Services Mail Stop C5-01-14 7500 Security Boulevard Baltimore , MD 21244 Phone: 410 786-4169 Extension: 64169
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E-Mail: terri.postma@cms.hhs.gov
Unified Agenda
Title: Inpatient Psychiatric Facilities Prospective Payment System--Update for Rate Year and Fiscal Year Beginning July 1, 2011 (CMS-1346-F) Abstract: This rule is necessary to update the prospective payment rates for inpatient psychiatric facilities with discharges beginning July 1, 2011. Priority: Economically Significant Agenda Stage of Rulemaking: Completed Action Unfunded Mandates: No Major: Yes CFR Citation: 42 CFR 412.400, subpart N (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: PL 106-113, sec 124 BBRA Legal Deadline:
Timetable:
Regulatory Flexibility Analysis Required: No Small Entities Affected: Business Agency Contact: Janet Samen Director, Division of Chronic Care Management Department of Health and Human Services Centers for Medicare & Medicaid Services Mail Stop C5-05-27 7500 Security Boulevard Baltimore , MD 21244 Phone: 410 786-4533 E-Mail: janet.samen@cms.hhs.gov
Government Levels Affected: Local Federalism: No
Title: Proposed Changes to the Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and FY 2012 Rates and to the Long-Term Care Hospital PPS and FY 2012 Rates (CMS-1518-F) Abstract: This rule revises the Medicare hospital inpatient and long-term care hospital prospective payment systems for operating and capital-related costs. This rule implements changes arising from our continuing experience with these systems. Priority: Economically Significant Agenda Stage of Rulemaking: Completed Action Major: Yes Unfunded Mandates: No CFR Citation: 42 CFR 412 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: sec 1886(d) of the Social Security Act; PL 111-148 secs 3004, 3025 Legal Deadline:
Action NPRM Other Source Statutory Statutory Description Date 04/01/2011 08/01/2011
Timetable:
Action Date FR Cite
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NPRM NPRM Comment Period End Final Action

05/05/2011 06/20/2011 08/18/2011 76 FR 51476 76 FR 25788
Unified Agenda
Additional Information: Includes Retrospective Review under E.O. 13563. Regulatory Flexibility Analysis Required: Business Government Levels Affected: No Federalism: No Energy Affected: No Agency Contact: Ankit Patel Health Insurance Specialist, Division of Acute Care Department of Health and Human Services Centers for Medicare & Medicaid Services Hospital and Ambulatory Policy Group Mail Stop, C4-25-11 7500 Security Boulevard Baltimore , MD 21244 Phone: 410 786-4537 E-Mail: ankit.patel@cms.hhs.gov
Title: Revisions to Payment Policies Under the Physician Fee Schedule and Part B for CY 2012 (CMS-1524-FC) Abstract: This annual rule revises payment polices under the physician fee schedule, as well as other policy changes to payment under Part B. These changes are be applicable to services furnished on or after January 1. Priority: Economically Significant Agenda Stage of Rulemaking: Completed Action Unfunded Mandates: No Major: Yes CFR Citation: 42 CFR 410; 42 CFR 414; 42 CFR 415; 42 CFR 495 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: Social Security Act, sec 1102; Social Security Act, sec 1871; PL 111-148 Legal Deadline: The statute requires that the final rule be issued by November.
Timetable:
Action NPRM NPRM Comment Period End Final Action Final Action Effective Date 07/19/2011 08/30/2011 11/28/2011 01/01/2012 76 FR 73026 FR Cite 76 FR 42772
Additional Information: Includes Retrospective Review under E.O. 13563. Regulatory Flexibility Analysis Required: Business; Organizations Federalism: No Energy Affected: No Agency Contact: Christina Ritter Director, Division of Practitioner Services Department of Health and Human Services Centers for Medicare & Medicaid Services Mail Stop C4-03-06 7500 Security Boulevard Baltimore , MD 21244 Phone: 410 786-4636 E-Mail: christina.ritter@cms.hhs gov Government Levels Affected: Federal
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Title: Changes to the Hospital Outpatient Prospective Payment System and Ambulatory Surgical Center Payment System for CY 2012 (CMS-1525-F) Abstract: This rule revises the Medicare hospital outpatient prospective payment system to implement applicable statutory requirements and changes arising from our continuing experience with this system. The proposed rule also describes changes to the amounts and factors used to determine payment rates for services. In addition, the rule finalizes changes to the Ambulatory Surgical Center Payment System list of services and rates. Priority: Economically Significant Agenda Stage of Rulemaking: Completed Action Unfunded Mandates: No Major: Yes CFR Citation: 42 CFR 410; 42 CFR 411; 42 CFR 416; 42 CFR 419; 42 CFR 489; 42 CFR 495 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: Social Security Act, sec 1833; PL 111-148 sec 6001 Legal Deadline:
Timetable:
Additional Information: Includes Retrospective Review under E.O. 13563. Regulatory Flexibility Analysis Required: Business Federalism: No Energy Affected: No Agency Contact: Paula Smith Health Insurance Specialist Department of Health and Human Services Centers for Medicare & Medicaid Services Mail Stop, C4-05-13 7500 Security Boulevard Baltimore , MD 21244 Phone: 410 786-4709 E-Mail: paula.smith@cms.hhs.gov Government Levels Affected: Federal
Title: End-Stage Renal Disease Prospective Payment System for CY 2012, Quality Incentive Program for PY 2013 and PY 2014; Ambulance Fee Schedule; and Durable Medical Equipment (CMS-1577-F) Abstract: This major rule updates the bundled payment system for End Stage Renal Disease (ESRD) facilities by January 1, 2012, as required by MIPPA. The rule also updates the Quality Incentives in the ESRD Program. In addition, this rule revises the ambulance fee schedule regulations to conform with statutory changes. Finally, this rule revises the definition of durable medical equipment (DME) by adding a 3-year minimum lifetime criterion that must be met by an item or device in order to be considered durable for the purpose of classifying the item under the Medicare benefit category for DME. Priority: Economically Significant Agenda Stage of Rulemaking: Completed Action Unfunded Mandates: No Major: Yes CFR Citation: 42 CFR 410; 42 CFR 413; 42 CFR 414 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: sec 1881 of the Social Security Act; MIPPA sec 153(c), MMEA Legal Deadline:
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Unified Agenda
11/01/2011
Timetable:
Regulatory Flexibility Analysis Required: No Small Entities Affected: Business Energy Affected: No Agency Contact: Janet Samen Director, Division of Chronic Care Management Department of Health and Human Services Centers for Medicare & Medicaid Services Mail Stop C5-05-27 7500 Security Boulevard Baltimore , MD 21244 Phone: 410 786-4533 E-Mail: janet.samen@cms.hhs.gov
Title: Prospective Payment System for Inpatient Rehabilitation Facilities for FY 2012; Changes in Size of Inpatient Rehabilitation Units and Inpatient Psychiatric Units (CMS-1349-F) Abstract: This major rule implements section 3004 of the Affordable Care Act, which establishes a new quality reporting program that provides for a reduction in the annual increase factor beginning in 2014 for failure to report quality data to the Secretary of Health and Human Services. This rule also updates the prospective payment rates for inpatient rehabilitation facilities (IRFs) for Federal fiscal year 2012 (for discharges occurring on or after October 1, 2011 and on or before September 30, 2012) as required under section 1886(j)(3)(C) of the Social Security Act (the Act). Section 1886(j)(5) of the Act requires the Secretary to publish in the Federal Register on or before the August 1 that precedes the start of each FY the classification and weighting factors for the IRF prospective payment system (PPS) case-mix groups and a description of the methodology and data used in computing the prospective payment rates for that fiscal year. We are also consolidating, clarifying, and revising existing policies regarding IRF hospitals and IRF units of hospitals to eliminate unnecessary confusion and enhance consistency. Furthermore, in accordance with the general principles of the President's January 18, 2011 Executive Order entitled "Improving Regulation and Regulatory Review," we are amending existing regulatory provisions regarding "new" facilities and changes in the bed size and square footage of IRFs and inpatient psychiatric facilities (IPFs) to improve clarity and remove obsolete material. Priority: Economically Significant Agenda Stage of Rulemaking: Completed Action Unfunded Mandates: No Major: Yes CFR Citation: 42 CFR 412 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: Social Security Act, sec 1886(j); PL 106-554; PL106-113; PL 111-148, sec 3004 Legal Deadline:
Timetable:
Additional Information: Includes Retrospective Review under E.O. 13563. Regulatory Flexibility Analysis Required: No Small Entities Affected: Business Energy Affected: No Government Levels Affected: Federal Federalism: No
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Agency Contact: Gwendolyn Johnson Health Insurance Specialist Department of Health and Human Services Centers for Medicare & Medicaid Services Center for Medicare Management Mail Stop C5-06-27 7500 Security Boulevard Baltimore , MD 21244 Phone: 410 786-6954 E-Mail: gwendolyn.johnson@cms.hhs.gov
Title: Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities for FY 2012; Required Disclosures of Ownership (CMS-1351-F) Abstract: This major rule finalizes two options for updating the payment rates used under the prospective payment system (SNFs), for fiscal year 2012. In this context, it examines recent changes in provider behavior relating to the implementation of the Resource Utilization Groups, version 4 (RUG-IV) case-mix classification system, discusses how such changes may affect the objective of maintaining parity in overall expenditures between RUG-IV and the previous case-mix classification system, and considers a possible recalibration of the case-mix indexes so that they more accurately reflect parity in expenditures. It also includes a discussion of a Non-Therapy Ancillary component and outlier research currently under development within CMS. In addition, this rule discusses the impact of certain provisions of the Affordable Care Act , and new programs and initiatives affecting SNFs. It also implements section 3401(b) of the Affordable Care Act, which requires for fiscal year 2012 and subsequent fiscal years that the SNF market basket percentage change be reduced by the multi-factor productivity adjustment described in section 1886(b)(3)(B)(xi)(II) of the Act. It also implements section 6101 of the Affordable Care Act, which requires Medicare SNFs and Medicaid nursing facilities to disclose certain information to the Secretary and other entities regarding the ownership and organizational structure of their facilities. Priority: Economically Significant Agenda Stage of Rulemaking: Completed Action Unfunded Mandates: No Major: Yes CFR Citation: 42 CFR 482 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: Social Security Act, sec 1888(e), PL 111-148, sec 6101 Legal Deadline:
Timetable:
Regulatory Flexibility Analysis Required: Business Government Levels Affected: Federal Federalism: No Energy Affected: No Agency Contact: William Ullman Technical Advisor Department of Health and Human Services Centers for Medicare & Medicaid Services Centers for Medicare Management Mail Stop C5-06-27 7500 Security Boulevard Baltimore , MD 21244 Phone: 410 786-5667 FAX: 410 786-0765 E-Mail: bill.ullman@cms.hhs.gov
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Title: Home Health Prospective Payment System Refinements and Rate Update for CY 2012 (CMS-1353-F) Abstract: This rule updates the 60-day national episode rate (based on the applicable Home Health Market Basket Update and case-mix adjustment) and would also update the national per-visit rates (used to calculate low utilization payment adjustments (LUPAs) and outlier payments) amounts under the Medicare Prospective Payment System for home health agencies. These changes are applicable to services furnished on or after January 1st. Agenda Stage of Rulemaking: Completed Action Priority: Economically Significant Major: Yes Unfunded Mandates: No CFR Citation: 42 CFR 484; 42 CFR 409; 42 CFR 424 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: Social Security Act, secs 1102 and 1871; 42 USC 1302 and 1395(hh); Social Security Act, sec 1895; 42 USC 1395(fff), PL 111-148 secs 3131, 3401, 6407 Legal Deadline:
Timetable:
Additional Information: Includes Retrospective Review under E.O. 13563. Regulatory Flexibility Analysis Required: Business Government Levels Affected: Federal Federalism: No Energy Affected: No Agency Contact: Kelly Horney Health Insurance Specialist, Department of Health and Human Services Centers for Medicare & Medicaid Services Center for Medicare Management Mail Stop C5-07-28 7500 Security Boulevard Baltimore , MD 21244 Phone: 410 786-0558 FAX: 410 786-0765 E-Mail: kelly.horney@cms.hhs.gov
Title: Hospice Wage Index for FY 2012 (CMS-1355-F) Abstract: This rule announces the annual update to the hospice wage index to reflect local differences in wage levels. The update takes effect October 1. Priority: Other Significant Agenda Stage of Rulemaking: Completed Action Unfunded Mandates: No Major: No CFR Citation: 42 CFR 418 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: 1814(i) (1) of the Act, 1814(i) (2); PL 111-148 sec 3004 Legal Deadline:
Timetable:
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Final Action

08/04/2011 76 FR 47302
Unified Agenda
Additional Information: Includes Retrospective Review under E.O. 13563. Regulatory Flexibility Analysis Required: No Small Entities Affected: Business Energy Affected: No Agency Contact: Katherine Lucas Health Insurance Specialist Department of Health and Human Services Centers for Medicare & Medicaid Services Mail Stop C5-08-23 7500 Security Boulevard Baltimore , MD 21244 Phone: 410 786-7723 E-Mail: katherine.lucas@cms.hhs.gov Government Levels Affected: Federal Federalism: No
Title: Payment Adjustment for Provider--Preventable Conditions Including Health Care-Acquired Conditions (CMS-2400-F) Abstract: This rule, under the Affordable Care Act of 2010, would prohibit Medicaid payment for services related to health care acquired conditions. Priority: Other Significant Agenda Stage of Rulemaking: Completed Action Unfunded Mandates: No Major: No CFR Citation: 42 CFR 434; 42 CFR 438; 42 CFR 447 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: PL 111-148, sec 2702 Legal Deadline:
Timetable:
Regulatory Flexibility Analysis Required: No Government Levels Affected: State Federalism: No Energy Affected: No Agency Contact: Venesa Day Health Insurance Specialist Department of Health and Human Services Centers for Medicare & Medicaid Services Center for Medicaid and State Operations Mail Stop S3-13-15 7500 Security Boulevard Baltimore , MD 21244 Phone: 410 786-8281 E-Mail: venesa.day@cms.hhs.gov
Title: Medicaid Automated Data System Requirements and Data Elements Necessary for Program Integrity, Program Oversight, and Administration (CMS-2317-P)
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Abstract: This proposed rule would implement several provisions of the Affordable Care Act of 2010. It would implement the provision that requires States, for data submitted on or after January 1, 2010, to include data elements from the automated data system that CMS determines to be necessary for program integrity, program oversight, and administration, at such frequency as CMS shall determine. It also would implement the provision that requires for managed care patients that the managed care plans provide data to States at a frequency and level of detail as specified by CMS. In addition, the rule would implement the provision that provides for withholding of Federal Matching Payments to States that fail to report enrollee encounter data in the Medicaid Statistical Information System. Priority: Other Significant Agenda Stage of Rulemaking: Completed Action Unfunded Mandates: No Major: No CFR Citation: None (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: PL 111-148, sec 6402(c); PL 111-148, sec 6504(a); PL 111-148, sec 6504(b); PL 111-148, sec 6503; PL 111-148, sec 6505; ... Legal Deadline:
Timetable:
Regulatory Flexibility Analysis Required: No Federalism: No Energy Affected: No Agency Contact: Karen Raschke Deputy Director, Data and Systems Group Department of Health and Human Services Centers for Medicare & Medicaid Services 7500 Security Boulevard Baltimore , MD 21244 Phone: 410 786-0016 E-Mail: karen.raschke@cms.hhs.gov
Government Levels Affected: Tribal
Title: HIPAA Mental Health Parity and Addiction Equity Act of 2008 Amendments (CMS-4140-F) Abstract: This final rule would further clarify statutory changes to the Public Health Services Act (PHSA) affecting the group health insurance markets and non-federal governmental plans, made by the Mental Health Parity and Addiction Equity Act of 2008 (MHPAEA). Priority: Economically Significant Agenda Stage of Rulemaking: Completed Action Major: Undetermined Unfunded Mandates: No CFR Citation: 45 CFR 136 and 146 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: PL 110-343 Legal Deadline: None Timetable:
Action Request for Information Request for Information Comment Period Ended Interim Final Rule Interim Final Rule Comment Period End Withdrawn Date 04/28/2009 05/28/2009 02/02/2010 05/03/2010 11/17/2011 75 FR 5410 FR Cite 74 FR 19155

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Related RINs: Related to 0938-AP65 Agency Contact: James Mayhew Health Insurance Specialist Department of Health and Human Services Centers for Medicare & Medicaid Services 7500 Security Boulevard Baltimore , MD 21244 Phone: 301 492-4113 E-Mail: james.mayhew@cms.hhs.gov

Related Agencies: Joint: EBSA; Joint: IRS
Unified Agenda
Title: Enhanced Federal Funding for Medicaid Eligibility Determination and Enrollment Activities (CMS-2346-F) Abstract: The Affordable Care Act requires States' residents to apply, enroll, receive determinations, and participate in the State health subsidy programs known as "the Exchange". The Affordable Care Act requires many changes to State eligibility and enrollment systems and each State is responsible for developing a secure, electronic interface allowing the exchange of data. Existing legacy eligibility systems are not able to implement the numerous requirements. This rule is key to informing States about the higher rates that CMS will provide to help them update or build legacy eligibility systems that meet the ACA requirements. Agenda Stage of Rulemaking: Completed Action Priority: Economically Significant Major: Yes Unfunded Mandates: No CFR Citation: 42 CFR 433 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: PL 111-148, sec 1413 Legal Deadline: None Timetable:
Regulatory Flexibility Analysis Required: Governmental Jurisdictions Federalism: Yes Energy Affected: No Agency Contact: Richard H. Friedman Director, Division of State Systems Department of Health and Human Services Centers for Medicare & Medicaid Services Mail Stop S3-18-13 7500 Security Boulevard Baltimore , MD 21244 Phone: 410 786-4451 E-Mail: richard.friedman@cms.hhs.gov
Title: Medicaid Program; Federal Medical Assistance Percentages (FMAP) for Newly Eligible Mandatory Individuals and Expansion States (CMS-2327-P) Abstract: This proposed rule sets forth methodologies for FMAP calculations. And the related conditions and requirements that will be available for State medical assistance expenditures relating to "newly eligible" individuals and certain medical assistance expenditures in "Expansion States" beginning January 1, 2014, under the Affordable Care Act of 2010 . This proposed rule also sets out allowable methodologies for States to use for purposes of applying the appropriate FMAP for expenditures for "newly
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eligible" individuals in accordance with section 2001 of the Affordable Care Act. Priority: Other Significant Agenda Stage of Rulemaking: Completed Action Unfunded Mandates: No Major: No CFR Citation: 42 CFR 433 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: PL 111-148, sec 2001 Legal Deadline:
Timetable:
Regulatory Flexibility Analysis Required: No Small Entities Affected: No Energy Affected: No Agency Contact: Diane Gerrits Senior Policy Advisor Department of Health and Human Services Centers for Medicare & Medicaid Services Mail Stop S3-14-23 7500 Security Boulevard Baltimore , MD 21244 Phone: 410 786-5776 E-Mail: diane.gerrits@cms.hhs.gov
Government Levels Affected: State Federalism: Yes
Title: Revisions to Medicare Advantage and Part D Prescription Drug Programs; MIPPA-Related Marketing Revisions and Agent/Broker Compensation Plan (CMS-4138-F) Abstract: This rule finalizes several Medicare Advantage and Part D prescription drug program provisions specified in MIPPA along with additional marketing requirements. These provisions affect special needs plans, private-fee-for-service plans, regional preferred provider organizations, and medical savings accounts plans. The rule also finalizes provisions related to the marketing of Part C and D plans; cost-sharing for dual eligible enrollees; and Part D prescription drug program pricing, coverage, and payment processes. Agenda Stage of Rulemaking: Completed Action Priority: Economically Significant Major: Yes Unfunded Mandates: No CFR Citation: 42 CFR 417; 42 CFR 422; 42 CFR 423 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: MIPPA; 42 USC 1302 and 42 USC 1395hh Legal Deadline:
Action Other Source Statutory MMA Section 902 Description Date 09/18/2011
Timetable:
Regulatory Flexibility Analysis Required: No Small Entities Affected: Business Energy Affected: No Related RINs: Related to 0938-AP52 Agency Contact: Vanessa Duran Supervisory Health Insurance Specialist Department of Health and Human Services Centers for Medicare & Medicaid Services
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Division of Policy, Analysis and Planning 7500 Security Boulevard Mail Stop C4-21-26 Baltimore , MD 21244 Phone: 410 786-8697 E-Mail: vanessa.duran@cms.hhs.gov
Title: Medicaid Program Integrity: Registration of Billing Agents, Clearing Houses, or Other Alternate Payees (CMS-2365-P) Abstract: This proposed rule would require any agent, clearinghouse, or other alternate payee that submits claims on behalf of a health care provider to register with the State and the Secretary in a form and manner specified by the Secretary. Agenda Stage of Rulemaking: Completed Action Priority: Other Significant Major: Undetermined Unfunded Mandates: Undetermined CFR Citation: Not Yet Determined (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: 42 USC 1396 a (a) (79) Social Security Act; PL 111-148, sec 6503 Legal Deadline: None Timetable:
Regulatory Flexibility Analysis Required: Undetermined Federalism: No Energy Affected: Undetermined Agency Contact: Richard Friedman Director, Division of State Systems Department of Health and Human Services Centers for Medicare & Medicaid Services Mail Stop S3-18-13 7500 Security Boulevard Baltimore , MD 21244 Phone: 410 786-4451 E-Mail: richard.friedman@cms.hhs.gov
Title: Public Use Files of Health Plan Data (CMS-9984-P) Abstract: The Affordable Care Act requires generating public use files on data that HHS collects from health plans, and includes specific data and their application (or not) to the Trade Secrets Act. This rule would clarify statutory requirements under the Affordable Care Act. Priority: Other Significant Agenda Stage of Rulemaking: Completed Action Major: No Unfunded Mandates: No CFR Citation: 45 CFR 159 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: PL 111-148 Legal Deadline: None Timetable:
Government Levels Affected: No Federalism: No 158
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Energy Affected: No Agency Contact: Elizabeth Hadley Health Insurance Specialist Department of Health and Human Services Centers for Medicare & Medicaid Services 7500 Security Boulevard Baltimore , MD 21244 Phone: 301 492-4222 E-Mail: elizabeth.hadley@hhs.gov
Unified Agenda
Title: Medical Loss Ratios (CMS-9998-FC) Abstract: The Affordable Care Act requires health insurance issuers offering individual or group coverage to submit annual reports to the Secretary on the percentages of premiums that the coverage spends on reimbursement for clinical services and activities that improve health care quality, and to provide rebates to enrollees if this spending does not meet minimum standards for a given plan year. This final rule implements the definition and methodology associated with the calculation of the Medical Loss Ratio (MLR) provisions of the Affordable Care Act and the calculation of the rebate to consumers for plans that do not satisfy the MLR. Agenda Stage of Rulemaking: Completed Action Priority: Other Significant Major: No Unfunded Mandates: No CFR Citation: 45 CFR 158 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: PL 111-148 Legal Deadline:
Timetable:
Action Interim Final Rule Interim Final Rule Effective Interim Final Rule Comment Period End Final Action Date 12/01/2010 01/01/2011 01/31/2011 12/07/2011 76 FR 76574 FR Cite 75 FR 74864
Regulatory Flexibility Analysis Required: No Federalism: No Energy Affected: No Agency Contact: James Mayhew Health Insurance Specialist Department of Health and Human Services Centers for Medicare & Medicaid Services 7500 Security Boulevard Baltimore , MD 21244 Phone: 301 492-4113 E-Mail: james.mayhew@cms.hhs.gov
Title: Elimination of the Requirement for Termination of Non-Random Prepayment Complex Medical Review (CMS-6022-F2) Abstract: This final rule removes the regulatory requirements regarding the termination of non-random prepayment complex medical review.
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Priority: Other Significant Agenda Stage of Rulemaking: Completed Action Major: No Unfunded Mandates: No CFR Citation: 42 CFR 421 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: PL 111-152, sec 1302 Legal Deadline: None Timetable:
Action Merged With 0938 -AR11 Date 12/31/2011 FR Cite
Regulatory Flexibility Analysis Required: No Small Entities Affected: Business Related RINs: Related to 0938-AN31 Agency Contact: Debbie Skinner Health Insurance Specialist Department of Health and Human Services Centers for Medicare & Medicaid Services 7500 Security Boulevard Baltimore , MD 21244 Phone: 410 786-7480 E-Mail: debbie.skinner@cms.hhs.gov
Title: Five Year Review of Work Relative Value Units Under the Physician Fee Schedule (CMS-1582-PN) Abstract: This proposed notice sets forth proposed revisions to work relative value units (RVUs) affecting payment for physicians' services. The Act requires that we review RVUs no less than every five years. The revised values will be finalized in the CY 2012 Physician Fee Schedule final rule and will be effective for services furnished beginning January 1, 2012. Priority: Other Significant Agenda Stage of Rulemaking: Completed Action Major: No Unfunded Mandates: No CFR Citation: None (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: SSA, sec 1848(c)(2)(B)(i) Legal Deadline: The comment period for this proposed notice must end prior to the start of the annual CY 2012 PFS proposed rule comment period.
Timetable:
Action Notice Merged With 0938 -AQ25 Date 06/06/2011 07/07/2011 FR Cite 76 FR 32410
Regulatory Flexibility Analysis Required: Business Federalism: No Energy Affected: No Agency Contact: Rebecca Cole Health Insurance Specialist Department of Health and Human Services Centers for Medicare & Medicaid Services Mail Stop: C4-03-06 7500 Security Boulevard Baltimore , MD 21244 Phone: 410 786-1589 E-Mail: rebecca.cole@cms.hhs.gov
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Title: Changes to the End-Stage Renal Disease Prospective Payment System Transition Budget-Neutrality Adjustment (CMS1435-IFC) Abstract: This interim final rule with comment will revise the end-stage renal disease (ESRD) transition budget-neutrality adjustment factor finalized in the CY 2011 ESRD Prospective Payment System (PPS) final rule published on August 12, 2010. Priority: Other Significant Agenda Stage of Rulemaking: Completed Action Unfunded Mandates: No Major: No CFR Citation: 42 CFR 413 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: sec 1881 of the Social Security Act Legal Deadline: None Timetable:
Action Interim Final Rule Merged With 0938 -AQ27 Interim Final Rule Comment Period End Date 04/06/2011 06/07/2011 06/06/2011 FR Cite 76 FR 18930
Regulatory Flexibility Analysis Required: No Government Levels Affected: No Small Entities Affected: Business Federalism: No Agency Contact: Janet Samen Division Director of Chronic Care Management Department of Health and Human Services Centers for Medicare & Medicaid Services Centers for Medicare Management Mail Stop C5-05-27 7500 Security Boulevard Baltimore , MD 21244 Phone: 410 786-9161 E-Mail: janet.samen@cms.hhs.gov
Title: Establishment of the Consumer Operated and Oriented Plan Program (CMS-9983-F) Abstract: Under section 1322 of the Affordable Care Act, a Consumer Operated and Oriented Plan program (CO-OP program) must be established to foster the creation of "qualified nonprofit health insurance issuers" that will offer qualified health plans in the individual and small group markets. Such qualified nonprofit issuers must operate with a strong consumer focus and use any profits to lower premiums, improve benefits, or improve the quality of health care delivered to plan members. Agenda Stage of Rulemaking: Completed Action Priority: Economically Significant Major: Yes Unfunded Mandates: No CFR Citation: 45 CFR 170 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: PL 111-148, sec 1322 Legal Deadline:
Action Other Source Statutory Description Grants and loans must be awarded by 7/1/2013. Date 07/01/2013
Timetable:

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Small Entities Affected: Organizations Federalism: No Related RINs: Related to 0938-AQ82 Agency Contact: Barbara Smith Associate Director, Consumer Operated and Oriented Plan Program Department of Health and Human Services Centers for Medicare & Medicaid Services 7500 Security Boulevard Baltimore , MD 21244 Phone: 301 492-4455 E-Mail: barbara.smith@cms.hhs.gov
Title: Changes to the Electronic Prescribing (eRx) Incentive Program for Calendar Year 2011 (CMS-3248-F) Abstract: This rule modifies the 2011 electronic prescribing (eRx) quality measure (that is, the eRx quality measure used for reporting periods in calendar year (CY) 2011) and provides additional significant hardship exemption categories for eligible professionals and group practices to request an exemption during 2011 for the 2012 eRx payment adjustment due to a significant hardship. Agenda Stage of Rulemaking: Completed Action Priority: Other Significant Major: No Unfunded Mandates: No CFR Citation: 42 CFR 414 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: MIPPA, sec132 Legal Deadline: None Timetable:
Regulatory Flexibility Analysis Required: No Small Entities Affected: Business Agency Contact: Aucha Prachanronarong Health Insurance Specialist Department of Health and Human Services Centers for Medicare & Medicaid Services Mailstop S3-02-01 7500 Security Blvd Baltimore , MD 21244 Phone: 410 786-1879 E-Mail: aucha.prachanronarong@cms.hhs.gov
Title: Clinical Laboratory Fee Schedule; Signature on Requisition (CMS-1436-P) Abstract: This proposed rule would address the signature requirement on requisitions for clinical diagnostic laboratory tests paid under the Clinical Laboratory Fee Schedule (CLFS) originally established in the CY 2011 Physician Fee Schedule final rule published on November 29, 2010. Priority: Info./Admin./Other Agenda Stage of Rulemaking: Completed Action Unfunded Mandates: No Major: No CFR Citation: 42 CFR 410 (To search for a specific CFR, visit the Code of Federal Regulations )
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Legal Authority: Social Security Act Legal Deadline: None Timetable:
Action NPRM Merged With 0938 -AQ25 NPRM Comment Period End
Unified Agenda
Date 06/30/2011 07/22/2011 08/29/2011
FR Cite 76 FR 38342
Additional Information: Includes Retrospective Review under E.O. 13563. Regulatory Flexibility Analysis Required: No Small Entities Affected: No Energy Affected: No Agency Contact: Glenn McGuirk Health Insurance Specialist Department of Health and Human Services Centers for Medicare & Medicaid Services Mail Stop C4-01-26 7500 Security Boulevard Baltimore , MD 21244 Phone: 410 786-5723 E-Mail: glenn.mcguirk@cms.hhs.gov Government Levels Affected: No Federalism: No
Title: Exchange Functions in the Individual Market: Eligibility Determinations; Standards for Verification of Employer-Sponsored Health Coverage, Employer Appeals, and Employer SHOP Participation (CMS-9974-F Abstract: This rule continues to implement the new Affordable Insurance Exchanges (Exchanges), consistent with title I of the Affordable Care Act of 2010. The Exchanges will provide competitive marketplaces for individuals and small employers to directly compare available private health insurance options on the basis of price, quality, and other factors. The Exchanges, which will become operational by January 1, 2014, will help enhance competition in the health insurance market, improve choice of affordable health insurance, and give small businesses the same purchasing clout as large businesses. Agenda Stage of Rulemaking: Completed Action Priority: Economically Significant Major: Yes Unfunded Mandates: No CFR Citation: 45 CFR 155; 45 CFR 157 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: PL111-148 secs 1311, 1411, 1412, and 1413 Legal Deadline:
Timetable:
Action NPRM NPRM Comment Period End Merged With 0938 -AQ67 Date 08/17/2011 10/31/2011 12/31/2011 FR Cite 76 FR 51202
Regulatory Flexibility Analysis Required: Undetermined Government Levels Affected: No Federalism: No Small Entities Affected: Business Energy Affected: No Agency Contact: Alissa Deboy Health Insurance Specialist, Center for Consumer Information & Insurance Oversight Department of Health and Human Services Centers for Medicare & Medicaid Services 7500 Security Boulevard Baltimore , MD 21244 Phone: 301 492-4428 163
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E-Mail: alissa.deboy1@cms.hhs.gov
Unified Agenda
Title: Rate Increase Disclosure and Review: Definitions of "Individual Market" and "Small Group Market" (CMS-9999-F) Abstract: This final rule addresses public comments that we received on a May 23, 2011, final rule with comment period entitled "Rate Increase Disclosure and Review." This final rule addresses the public comments we received and amends the definitions of "individual market" and "small group market" to include coverage sold to individuals and small groups through associations even if the State excludes the coverage from its definitions of individual and small group market coverage. This final rule updates requirements for health insurance issuers regarding disclosure and review of unreasonable premium increases under section 2794 of the Public Health Service Act. Agenda Stage of Rulemaking: Completed Action Priority: Other Significant Major: No Unfunded Mandates: No CFR Citation: 45 CFR 154 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: 42 USC 300gg-94 Legal Deadline: None Timetable:
Regulatory Flexibility Analysis Required: No Small Entities Affected: Business Related RINs: Related to 0938-AQ68 Agency Contact: James Mayhew Health Insurance Specialist Department of Health and Human Services Centers for Medicare & Medicaid Services 7500 Security Boulevard Baltimore , MD 21244 Phone: 301 492-4113 E-Mail: james.mayhew@cms.hhs.gov
Department of Health and Human Services (HHS) Office of Public Health and Science ( OPHS )
Title: Public Health Service Standards for the Protection of Research Misconduct Whistleblowers Abstract: To implement section 493(e) of the Public Health Service Act (added by sec. 163 of the National Institutes of Health Revitalization Act of 1993, Pub. L. 103-43), the Department is proposing to add a new part 94 to title 42 of the Code of Federal Regulations. Under this proposed regulation, covered institutions must follow certain requirements for preventing and responding to occurrences of retaliation against whistleblowers. The purpose of this part is to protect: 1) Persons who make a good faith allegation that a covered institution or member thereof engaged in, or failed to respond adequately, to an allegation of research misconduct; and 2) persons who cooperate in good faith with an investigation of research misconduct. Priority: Substantive, Nonsignificant Agenda Stage of Rulemaking: Completed Action Unfunded Mandates: No Major: No CFR Citation: 42 CFR 94 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: 42 USC 216 and 289b; 42 USC 241 Legal Deadline: None Timetable:
Action Date FR Cite
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NPRM Transferred to RIN 0937 -AA03

11/28/2000 08/10/2011 65 FR 70830
Unified Agenda
Regulatory Flexibility Analysis Required: No Small Entities Affected: No Related RINs: Related to 0940-AA04 Agency Contact: John Dahlberg Senior Scientist Department of Health and Human Services Office of Public Health and Science 1101 Wootton Parkway Rockville , MD 20852 Phone: 301 443-5300 E-Mail: john.dahlberg@hhs.gov
Department of Health and Human Services (HHS) Office for Civil Rights ( OCR )
Title: HIPAA Privacy Rule Accounting of Disclosures under the Health Information Technology for Economic and Clinical Health Act Abstract: The Department of Health and Human Services, Office for Civil Rights, will issue rules to modify the HIPAA Privacy Rule as necessary to implement the accounting of disclosures provisions of Section 13405(c) of the Health Information Technology for Economic and Clinical Health Act (Title XIII of the American Recovery and Reinvestment Act of 2009). Agenda Stage of Rulemaking: Final Rule Priority: Other Significant Major: No Unfunded Mandates: No CFR Citation: 45 CFR 164 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: PL 111-5, sec 13405(c) Legal Deadline:
Timetable:
Action NPRM NPRM Comment Period End Final Rule Date 05/31/2011 08/01/2011 06/00/2012 FR Cite 76 FR 31426
Regulatory Flexibility Analysis Required: Undetermined Federalism: No Agency Contact: Andra Wicks Privacy Specialist, Office of Civil Rights Department of Health and Human Services Office for Civil Rights 200 Independence Avenue SW. Washington , DC 20201 Phone: 202 205-2292 FAX: 202 205-4786 E-Mail: andra.wicks@hhs.gov
Title: Modifications to the HIPAA Privacy, Security, Enforcement, and Breach Notification Rules
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Abstract: The Department of Health and Human Services Office for Civil Rights will issue final rules to modify the HIPAA Privacy, Security, Enforcement, and Breach Notification Rules as necessary to implement the privacy, security, enforcement, and breach notification provisions of Subtitle D of the Health Information Technology for Economic and Clinical Health Act (Title XIII of the American Recovery and Reinvestment Act of 2009), and will modify the HIPAA Privacy Rule as required by section 105 of the Genetic Information Nondiscrimination Act of 2008. Priority: Economically Significant Agenda Stage of Rulemaking: Final Rule Unfunded Mandates: No Major: Undetermined CFR Citation: 45 CFR 160; 45 CFR 164 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: PL 111-5, secs 13400 to 13410; 42 USC 1320d-9 Legal Deadline:
Action Other Other Other Other Other Source Statutory Statutory Statutory Statutory Statutory Deadline for final GINA rule Deadline for Interim Final Rule on Breach Notification Effective date of certain HITECH privacy, security, and enforcement provisions Effective date of certain HITECH enforcement provisions Description Effective date of certain HITECH enforcement provisions Date 02/18/2009 05/21/2009 08/17/2009 02/18/2010 02/18/2011
Timetable:
Regulatory Flexibility Analysis Required: No Federalism: No Agency Contact: Andra Wicks Privacy Specialist, Office of Civil Rights Department of Health and Human Services Office for Civil Rights 200 Independence Avenue SW. Washington , DC 20201 Phone: 202 205-2292 FAX: 202 205-4786 E-Mail: andra.wicks@hhs.gov
Title: Nondiscrimination Under the Affordable Care Act Abstract: The Department of Health and Human Services, Office for Civil Rights, will issue rules for covered entities with respect to prohibitions against discrimination on the basis of race, color, national origin, sex, age, and disability, as provided in Section 1557 of the Affordable Care Act. Section 1557 provides certain protections from discrimination by recipients of federal financial assistance, federally conducted programs, and entities established under title I of the Affordable Care Act. This section also identifies additional forms of federal financial assistance to which the section will apply. Priority: Other Significant Agenda Stage of Rulemaking: Long-term Action Major: Undetermined Unfunded Mandates: Undetermined CFR Citation: Not Yet Determined (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: PL 111-148, sec 1557 Legal Deadline: None Timetable:
Regulatory Flexibility Analysis Required: Undetermined Federalism: Undetermined Energy Affected: Undetermined
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Agency Contact: Carole Brown Equal Opportunity Specialist Department of Health and Human Services Office for Civil Rights 200 Independence Avenue SW. Washington , DC 20201 Phone: 202 619-0805 E-Mail: carole.brown@hhs.gov
Unified Agenda
Title: Individual Access to Protected Health Information Held by CLIA Laboratories Abstract: The Department of Health and Human Services, Office for Civil Rights, will modify the HIPAA Privacy Rule to conform the access provisions to be consistent with new Centers for Medicare & Medicaid Services regulations that will provide for laboratories subject to the Clinical Laboratory Improvements Amendments of 1988 to provide individuals with access to their protected health information. Agenda Stage of Rulemaking: Completed Action Priority: Substantive, Nonsignificant Major: Undetermined Unfunded Mandates: Undetermined CFR Citation: 45 CFR 164 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: PL 104-191 sec 264 Legal Deadline: None Timetable:
Action NPRM NPRM Comment Period End Merged With 0938 -AQ38 Date 09/14/2011 11/14/2011 12/30/2011 FR Cite 76 FR 56712
Regulatory Flexibility Analysis Required: Undetermined Federalism: Undetermined Agency Contact: Andra Wicks Privacy Specialist, Office of Civil Rights Department of Health and Human Services Office for Civil Rights 200 Independence Avenue SW. Washington , DC 20201 Phone: 202 205-2292 FAX: 202 205-4786 E-Mail: andra.wicks@hhs.gov
Department of Health and Human Services (HHS) Administration for Children and Families ( ACF )
Title: Implementation of the Unaccompanied Alien Children (UAC) Provisions of the Trafficking Victims Reauthorization Act of 2008 Abstract: The William Wilberforce Trafficking Victims Protection Reauthorization Act of 2008 (the Act), Public Law 110-457, made significant changes concerning the care and placement of unaccompanied alien children while they are in the care of the Office of Refugee Resettlement (ORR). This rule would implement changes to the program under section 235 of the Act addressing issues like age determinations, placement determinations, suitability assessments, and home studies. This rule also will address provisions of the Flores settlement agreement that were not addressed in Public Law 110-457. Priority: Other Significant Major: No Agenda Stage of Rulemaking: Proposed Rule Unfunded Mandates: No 167
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CFR Citation: 45 CFR 410 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: 22 USC 7101 note, William Wilberforce Trafficking Victims Protection Reauthorization Act of 2008 Legal Deadline: None Timetable:
Regulatory Flexibility Analysis Required: No Small Entities Affected: No Energy Affected: No Agency Contact: Kenneth Tota Chief of Operations--Office of Refugee Resettlement Department of Health and Human Services Administration for Children and Families 370 L'Enfant Promenade SW. Washington , DC 20447 Phone: 202 401-4858 E-Mail: ktota@acf.hhs.gov
Title: Performance Standards for Runaway and Homeless Youth Grantees Abstract: This rule would implement section VIII of the Reconnecting Homeless Youth Act of 2008, requiring the Secretary of Health and Human Services to issue rules that specify performance standards for public and nonprofit private entities that receive grants under the Runaway and Homeless Youth Program. Priority: Other Significant Agenda Stage of Rulemaking: Proposed Rule Major: No Unfunded Mandates: No CFR Citation: 45 CFR 1351 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: Reconnecting Homeless Youth Act, PL 110-378 Legal Deadline:
Action Other Source Statutory Statutory. Description Date 10/08/2009
Timetable:
Regulatory Flexibility Analysis Required: No Small Entities Affected: Organizations Energy Affected: No Agency Contact: Curtis O. Porter Division Director, Family & Youth Services Bureau, ACYF Department of Health and Human Services Administration for Children and Families 370 L'Enfant Promenade SW. Washington , DC 20447 Phone: 202 205-8306 E-Mail: cporter@acf.hhs.gov
Government Levels Affected: Local; State; Tribal Federalism: No
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Unified Agenda
Title: Flexibility and Efficiency in Child Support Abstract: This regulation will propose a variety of changes to child support regulations that will result in more efficient and effective operations and give state child support agencies additional flexibility. The regulation will propose: (1) Changes to improve program management, including payment processing and disbursement; (2) updates to account for advances in technology; and (3) technical corrections. Agenda Stage of Rulemaking: Proposed Rule Priority: Other Significant Major: No Unfunded Mandates: No CFR Citation: 45 CFR 301 to 305; 45 CFR 307 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: sec 1102 of the Act Legal Deadline: None Timetable:
Regulatory Flexibility Analysis Required: No Small Entities Affected: No Energy Affected: No Agency Contact: Yvette Riddick Director, Division of Policy, OCSE Department of Health and Human Services Administration for Children and Families 370 L'Enfant Promenade SW. Washington , DC 20447 Phone: 202 401-4885 E-Mail: yriddick@acf.hhs.gov
Government Levels Affected: Federal; Local; State Federalism: No
Title: Federal Case Registry System of Records Exemption Abstract: HHS proposes to exempt Federal Case Registry records marked with the Family Violence Indicator from certain requirements of the Privacy Act to prevent disclosure of records pertaining to victims of domestic violence. Priority: Other Significant Agenda Stage of Rulemaking: Proposed Rule Unfunded Mandates: No Major: No CFR Citation: 45 CFR 5 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: 42 USC 652(a); 42 USC 1302 Legal Deadline: None Timetable:
Regulatory Flexibility Analysis Required: No Small Entities Affected: No Energy Affected: No Agency Contact: Linda Deimeke Director, Division of Federal Systems, OCSE Department of Health and Human Services Administration for Children and Families 370 L'Enfant Promenade SW. Washington , DC 20447 Phone: 202 401-5439
169
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E-Mail: ldeimeke@acf.hhs.gov
Unified Agenda
Title: Child Care and Development Fund Reforms to Support Child Development and Working Families Abstract: This proposed rule would provide the first comprehensive update of Child Care and Development Fund (CCDF) regulations since 1998. It would make changes in five key areas: (1) Improving health and safety; (2) improving the quality of child care; (3) establishing family-friendly policies; (4) increasing State flexibility through select provisions; and (5) strengthening program integrity. The changes would update the regulations to reflect: current research and knowledge about the early care and education sector; State innovations in policies and practices over the past decade; and increased recognition that high quality child care both supports work for low-income parents and promotes children's learning and healthy development. Agenda Stage of Rulemaking: Proposed Rule Priority: Other Significant Major: No Unfunded Mandates: No CFR Citation: 45 CFR 98 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: sec 658E and other provisions of the Child Care and Development Block Grant Act of 1990, as amended Legal Deadline: None Timetable:
Regulatory Flexibility Analysis Required: No Government Levels Affected: State; Tribal Small Entities Affected: No Federalism: No Energy Affected: No Agency Contact: Andrew Williams Program Specialist, Policy and Planning Division Department of Health and Human Services Administration for Children and Families Office of Child Support Enforcement 370 L'Enfant Promenade SW. Washington , DC 20447 Phone: 202 401-1467 FAX: 202 690-5600 E-Mail: andrew.williams@acf.hhs.gov
Title: Tribal Child Welfare Abstract: This rule would implement title III, Tribal Foster Care and Adoption Access, of the Fostering Connections to Success and Increasing Adoptions Act of 2008 (the Act). Under section 301 of the Act, the Secretary is required to promulgate interim final regulations to carry out the title III provisions, including providing for transfer of responsibility for the placement and care of a child under a state plan approved under section 471 of the Social Security Act to a tribal plan. This rule also will address inkind expenditures from third-party sources for purposes of determining the non-federal share of administrative and training expenditures as required in section 301 of the Act. Priority: Other Significant Agenda Stage of Rulemaking: Final Rule Unfunded Mandates: No Major: No CFR Citation: 45 CFR 1355 and 1356 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: Fostering Connections to Success and Increasing Adoptions Act of 2008 Legal Deadline:
170
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Other Statutory Statutory.
Unified Agenda
10/09/2009
Timetable:
Action Interim Final Rule Date 12/00/2011 FR Cite
Regulatory Flexibility Analysis Required: No Small Entities Affected: No Energy Affected: No Agency Contact: Elizabeth Sharp ACYF Department of Health and Human Services Administration for Children and Families 1250 Maryland Avenue SW Washington , DC 20447 Phone: 202 205-7265 FAX: 202 205-8221 E-Mail: esharp@acf.hhs.gov
Government Levels Affected: State; Tribal Federalism: No
Title: Head Start Eligibility Determinations Abstract: This regulation amends Head Start Program regulations to clarify and strengthen procedures to determine eligibility for Head Start program enrollment, including procedures to document and verify such eligibility. The intent of this rule is to reduce the risk of provision of Head Start services to persons who are not eligible for those services. Priority: Other Significant Agenda Stage of Rulemaking: Final Rule Major: No Unfunded Mandates: No CFR Citation: Not Yet Determined (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: 42 USC 9801 et seq Legal Deadline: None Timetable:
Regulatory Flexibility Analysis Required: No Small Entities Affected: No Energy Affected: No Agency Contact: Colleen Rathgeb Division Director, Policy and Budget, HS Department of Health and Human Services Administration for Children and Families 1250 Maryland Avenue SW. Washington , DC 20024 Phone: 202 205-7378 E-Mail: crathgeb@acf.hhs.gov

171
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Unified Agenda
Title: Designation Renewal of Head Start Grantees Abstract: This rule would implement provisions of the Improving Head Start for School Readiness Act of 2007 (Pub. L. 110134), requiring the Secretary to develop a system that will evaluate each grantee's performance every five years to determine which grantees are providing services of such high quality that they should be given another five-year grant without needing to recompete for the grant. Priority: Other Significant Agenda Stage of Rulemaking: Completed Action Unfunded Mandates: No Major: No CFR Citation: 45 CFR 1307 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: Improving Head Start for School Readiness Act of 2007, PL 110-134 Legal Deadline: None Timetable:
Regulatory Flexibility Analysis Required: No Government Levels Affected: No Small Entities Affected: No Federalism: No Energy Affected: No Agency Contact: Colleen Rathgeb Department of Health and Human Services Administration for Children and Families 1250 Maryland Avenue SW. Washington , DC 20447 Phone: 202 205-7378 E-Mail: crathgeb@acf.hhs.gov
Title: Strengthen Medical Support in the Child Support Program Abstract: Limited revisions will be made to medical support regulations to improve interoperability between Child Support and Medicaid and CHIP to be consistent with the CHIP Reauthorization Act of 2009, and the Secretary's public goal of enrolling all eligible uninsured children in Medicaid and CHIP by 2014. Priority: Other Significant Agenda Stage of Rulemaking: Completed Action Major: No Unfunded Mandates: No CFR Citation: 45 CFR 302 and 303; 45 CFR 308 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: secs 452(f) and 466(a)(19) of the Social Security Act (Act); sec 1102 of the Act Legal Deadline: None Timetable:
Regulatory Flexibility Analysis Required: No Small Entities Affected: No Energy Affected: No Agency Contact: Jennifer Burnszynski OCSE Department of Health and Human Services Administration for Children and Families 901 D Street SW. Washington , DC 20447 Phone: 202 401-5068 E-Mail: jburnszynski@acf.hhs.gov
172
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Unified Agenda
Title: Improving Payment Processing in the Child Support Enforcement Program Abstract: This proposed rule aims to address several significant barriers to effective payment processing experienced by employers, states and families. The Notice of Proposed Rulemaking (NPRM) will propose changes regarding the income withholding documentation; direction of income withholding payments from employers; state processing of all income withholding payments, including payments on non-IV-D orders, through the SDU; and SDU disbursement of payments. Agenda Stage of Rulemaking: Completed Action Priority: Other Significant Major: No Unfunded Mandates: No CFR Citation: 45 CFR 466(a) and 466(b) (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: secs 454A and 454B of the Act; sec 1102 of the Act Legal Deadline: None Timetable:
Regulatory Flexibility Analysis Required: No Small Entities Affected: No Energy Affected: No Agency Contact: Yvette Riddick Director, Division of Policy, OCSE Department of Health and Human Services Administration for Children and Families 370 L'Enfant Promenade SW. Washington , DC 20447 Phone: 202 401-4885 E-Mail: yriddick@acf.hhs.gov
Department of Health and Human Services (HHS) Administration on Aging ( AOA )
Title: Older Americans Act--Ombudsman Program Abstract: The Administration (AoA) intends to promulgate rules implementing title VII, chapter 2 of the Older Americans Act (OAA), as amended, i.e., the Ombudsman Program. Since 1992, the functions of this program have been delineated in 42 U.S.C. 3058g, however; regulations have not been promulgated for any title VII program. In the absence of regulatory guidance, there has been significant variation in the interpretation and implementation of these provisions among states. Recent inquiries from states and an AoA compliance review in one state have highlighted the difficulty of determining state compliance in carrying out the program functions. Priority: Substantive, Nonsignificant Agenda Stage of Rulemaking: Proposed Rule Unfunded Mandates: No Major: No CFR Citation: 45 CFR 1327 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: 42 USC 3058g Legal Deadline: None Timetable:

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Small Entities Affected: No Energy Affected: No Agency Contact: Deborah Burns Kuhn Aging Services Program Specialist Department of Health and Human Services Administration on Aging Washington , DC 20201 Phone: 202 357-3549 E-Mail: deborahburns.kuhn@aoa.hhs.gov

Federalism: No
Unified Agenda
Department of Health and Human Services (HHS) Administration on Aging ( AOA )
Title: Community Living Assistance Services and Supports (CLASS) Program--Designation of the CLASS Independence Benefit Plan and Enrollment Rules Abstract: The Department of Health and Human Services will issue rules to implement the Community Living Assistance Services and Supports (CLASS) program, which was enacted as part of the Affordable Care Act. Specifically, the rules will designate the CLASS Independence Benefit Plan and establish enrollment rules for the program. Participation in the program is voluntary. Priority: Other Significant Agenda Stage of Rulemaking: Completed Action Major: No Unfunded Mandates: No CFR Citation: 42 CFR 200 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: 42 USC 300-2(a)(1)(3); 42 USC 300-7(c) Legal Deadline: 42 U.S.C. 300-2(a)(1)(3)requires the Secretary of HHS to designate the CLASS Independence Benefit Plan in a final rule by 10/01/12.
Action Other Source Statutory Description Required by 42 U.S.C. 300 -2(a)(1)(3) Date 10/01/2012
Timetable:
Regulatory Flexibility Analysis Required: Undetermined Federalism: Undetermined Energy Affected: No Agency Contact: James Muetzel Management Analyst Department of Health and Human Services Administration on Aging Room 4718 1 Massachusetts Avenue NW. Washington , DC 20201 Phone: 202 357-3464
Department of Health and Human Services (HHS) Office of the Secretary ( OS )
RIN: 0991-AB83 View Related Documents
Title: Governance for a Nationwide Health Information Network Abstract: The National Coordinator for Health Information Technology (the National Coordinator) is required by section 3001(c)(8) of the Public Health Service Act to establish a governance mechanism for the Nationwide Health Information Network. Through this advance notice of proposed rulemaking (ANPRM), public comment will be sought on proposals and options relevant to the governance mechanism currently under consideration. Based on the public comments received, the National Coordinator would issue a subsequent notice of proposed rulemaking (NPRM) to formally propose a governance mechanism for the Nationwide Health Information Network. 174
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Unified Agenda
Priority: Routine and Frequent Agenda Stage of Rulemaking: PreRule Unfunded Mandates: No Major: No CFR Citation: 45 CFR 170 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: 42 USC 300jj-11 Legal Deadline: None Timetable:
Action ANPRM Date 02/00/2012 FR Cite
Regulatory Flexibility Analysis Required: Undetermined Government Levels Affected: Undetermined Federalism: Undetermined Energy Affected: No Agency Contact: Steven Posnack Policy Analyst Department of Health and Human Services Office of the Secretary Office of the National Coordinator for Health Information Technology 200 Independence Avenue SW. Washington , DC 20201 Phone: 202 690-7151
Title: Health Information Technology: New and Revised Standards, Implementation Specifications, and Certification Criteria for Electronic Health Record Technology Abstract: The final rule that established the initial set of standards, implementation specifications, and certification criteria was published in the Federal Register on July 28, 2010. The initial set represented the first round of an incremental approach to adopting future sets of standards, implementation specifications, and certification criteria to enhance electronic health record (EHR) interoperability, functionality, and utility. Under the authority provided by section 3004 of the Public Health Service Act (PHSA), this notice of proposed rulemaking would propose that the Secretary adopt revisions to the initial set as well as new standards, implementation specifications and certification criteria. The proposed new and revised standards, implementation specifications, and certification criteria would establish the technical capabilities that certified EHR technology would need to include to support meaningful use under the CMS Medicare and Medicaid EHR Incentive Programs. Priority: Other Significant Agenda Stage of Rulemaking: Proposed Rule Unfunded Mandates: No Major: Undetermined CFR Citation: 45 CFR 170 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: 42 USC 300jj-14 Legal Deadline: None Regulatory Plan: Statement of Need: The final rule that established the initial set of standards, implementation specifications, and certification criteria was published in the Federal Register on July 28, 2010. The initial set represented the first round of an incremental approach to adopting future sets of standards, implementation specifications, and certification criteria for electronic health record (EHR) technology. In a notice of proposed rulemaking, the Secretary would propose new and revised standards, implementation specifications, and certification criteria that would establish the technical capabilities that certified EHR technology would need to include in order to support meaningful use under the CMS Medicare and Medicaid EHR Incentive Programs. Legal Basis: Under the authority provided by section 3004 of the Public Health Service Act (PHSA), the Secretary would propose to adopt revisions to the initial set of standards, implementation specifications, and certification criteria and propose new standards, implementation specifications and certification criteria. Alternatives: No alternatives are available because eligible professionals, eligible hospitals, and critical access hospitals under the CMS Medicare and Medicaid EHR Incentive Programs are required to demonstrate meaningful use of certified EHR technology. This rule ensures that the certification requirements necessary to support the achievement of meaningful use Stage
175
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Unified Agenda
2 keep pace with the changes to the requirements in the CMS Medicare and Medicaid EHR Incentive Programs. Costs and Benefits: EHR technology developers seeking certification are expected to incur costs related to EHR technology redesign, reprogramming, and new capability development. Benefits include greater standardization and increased EHR technology interoperability and functionality. Risks: Absent a rulemaking, it is unlikely that currently certified EHR technology would include the requisite capacities to support an eligible professional's, eligible hospital's, or critical access hospital's achievement of meaningful use under the CMS Medicare and Medicaid EHR Incentive Programs. Timetable:
Regulatory Flexibility Analysis Required: Undetermined Government Levels Affected: No Federalism: No Energy Affected: No Agency Contact: Steven Posnack Policy Analyst Department of Health and Human Services Office of the Secretary Office of the National Coordinator for Health Information Technology 200 Independence Avenue SW. Washington , DC 20201 Phone: 202 690-7151
Title: Shared Risk Exception to the Safe Harbor Provisions Abstract: This final rule establishes a new safe harbor for risk-sharing arrangements under the Federal health care programs' anti-kickback provisions. The rule sets forth an exception from liability for remuneration between an eligible organization and an individual or entity providing items or services in accordance with a written agreement between these parties. The rule allows remuneration between an organization and an individual or entity if a written agreement places the individual or entity at "substantial financial risk" for the cost or utilization of the items or services that the individual or entity is obligated to provide. Priority: Substantive, Nonsignificant Agenda Stage of Rulemaking: Completed Action Major: No Unfunded Mandates: No CFR Citation: 42 CFR 1001 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: 42 USC 1302; 42 USC 1320a-7b; 42 USC 1395hh; PL 104-191, sec 216(b) Legal Deadline:
Timetable:
Action ANPRM ANPRM Comment Period End Interim Final Rule Interim Final Rule Comment Period End Transferred to RIN 0936 -AA00 Date 05/23/1997 06/09/1997 11/19/1999 01/18/2000 07/27/2011 64 FR 63504 FR Cite 62 FR 28410
Regulatory Flexibility Analysis Required: No Federalism: No Related RINs: Related to 0991-AB06 Agency Contact: Patrice S. Drew Regulations Analyst Department of Health and Human Services Office of the Secretary 330 Independence Avenue SW.
176
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Washington , DC 20201 Phone: 202 619-1368 E-Mail: patrice.drew@hhs.gov
Unified Agenda
Title: Principles for Determining Costs at Hospitals Under Federal Grants, Contracts, and Cooperative Agreements Abstract: This notice of proposed rulemaking will publish for a 30-day comment period revisions to 45 CFR part 74, appendix E: Principles for Determining Costs at Hospitals Under Federal Grants, Contracts, and Cooperative Agreements (hereinafter referred to as the Hospital Cost Principles or HCP). It is the culmination of a comprehensive review process begun in 2005, and incorporates relevant elements of the Office of Management and Budget circulars for Colleges and Universities (OMB Circular A21), Non-Profit Institutions (OMB Circular A-122), and State and Local Governments (OMB Circular A-87). These other principles were revised by OMB in the early 1990s, but the Hospital Cost Principles were not. Priority: Routine and Frequent Agenda Stage of Rulemaking: Completed Action Major: No Unfunded Mandates: No CFR Citation: 45 CFR 74, app E (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: 5 USC 301 5 USC 552 Legal Deadline: None Timetable:
Regulatory Flexibility Analysis Required: No Federalism: No Energy Affected: No Agency Contact: Michelle G. Bulls Director, Office Of Grants Policy Oversight & Evaluation Department of Health and Human Services Office of the Secretary 200 Independence Avenue SW. Washington , DC 20202 Phone: 202 720-1908 E-Mail: michelle.bulls@hhs.gov
Government Levels Affected: Local; State
Title: Rescission of Interest Prohibition in the Principles for Determining Costs at Hospitals Under Federal Grants, Contracts, and Cooperative Agreements Abstract: This Notice of Proposed Rulemaking (NPRM) would rescind the current prohibition against interest as an allowable expense. The recision applies only to interest endured for new construction, facility acquisitions, and interest debt to acquire or replace facility acquisitions. It makes the Hospital Cost Principles consistent with the Office of Management and Budget circulars for Colleges and Universities (OMB Circular A-21), Non-Profit Institutions (OMB Circular A-122), and State and Local Governments (OMB Circular A-87) concerning the allowance of interest debt. These other principles were revised in the early 1990s, but the Hospital Cost Principles were not. In 2000, the current interest request waiver process was established as a temporary practice to align the Hospital Cost Principles with A-21 and A-87 until a permanent revision could be published. Since then, 12 such waivers have been granted by the Department. The standards in this NPRM would be the same as those in A-21 and A-87. This NPRM establish the Department of Health and Human Services as the proponent agency for appendix E of 45 CFR part 74 with inherent responsibility to review, approve, and deny requests for waiver to Hospital Cost Principles. Priority: Routine and Frequent Major: No Agenda Stage of Rulemaking: Completed Action Unfunded Mandates: No 177
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Unified Agenda
CFR Citation: 42 CFR 74 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: 5 USC 301 5 USC 552 Legal Deadline: None Timetable:
Regulatory Flexibility Analysis Required: No Federalism: No Energy Affected: No Agency Contact: Michelle G. Bulls Director, Office Of Grants Policy Oversight & Evaluation Department of Health and Human Services Office of the Secretary 200 Independence Avenue SW. Washington , DC 20202 Phone: 202 720-1908 E-Mail: michelle.bulls@hhs.gov
Government Levels Affected: Local; State
Title: Revision to Prohibition on FFP for "Data Mining" by Medicaid Fraud Control Units Abstract: This notice proposes modifications to current regulations that prohibit State Medicaid Fraud Control Units (MFCUs) from using Federal matching funds to conduct efforts to identify situations in which a question of fraud may exist, including the screening of claims, analysis of patterns of practice, or routine verification with recipients of whether services billed by providers were actually received. The modifications would allow data mining to be conducted by MFCUs under limited circumstances. Agenda Stage of Rulemaking: Completed Action Priority: Other Significant Major: No Unfunded Mandates: No CFR Citation: 42 CFR 1007 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: 42 USC 1302; 42 USC 1396b(a)(6); 42USC 1396(b)(3); 42 USC 1396b(q) Legal Deadline: None Timetable:
Action NPRM NPRM Comment Period End Transferred to RIN 0936 -AA01 Date 03/17/2011 05/16/2011 07/27/2011 FR Cite 76 FR 14637
Regulatory Flexibility Analysis Required: No Federalism: No Energy Affected: Undetermined Agency Contact: Patrice S. Drew Regulations Analyst Department of Health and Human Services Office of the Secretary 330 Independence Avenue SW. Washington , DC 20201 Phone: 202 619-1368 E-Mail: patrice.drew@hhs.gov

178
RIN: 0991-AB62
Regulations.gov
Unified Agenda
Title: HIPAA Privacy Rule Accounting of Disclosures under the Health Information Technology for Economic and Clinical Health Act Abstract: The Department of Health and Human Services, Office for Civil Rights, will issue rules to modify the HIPAA Privacy Rule as necessary to implement the accounting of disclosures provisions of section 13405(c) of the Health Information Technology for Economic and Clinical Health Act (Title XIII of the American Recovery and Reinvestment Act of 2009). Agenda Stage of Rulemaking: Completed Action Priority: Other Significant Major: No Unfunded Mandates: No CFR Citation: 45 CFR 164 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: PL 111-5, sec 13405(c) Legal Deadline:
Timetable:
Action NPRM Transferred to RIN 0945 -AA00 NPRM Comment Period End Date 05/31/2011 07/27/2011 08/01/2011 FR Cite 76 FR 31426
Regulatory Flexibility Analysis Required: Undetermined Federalism: No Agency Contact: Andra Wicks Privacy Specialist, Office of Civil Rights Department of Health and Human Services Office of the Secretary 200 Independence Avenue SW. Washington , DC 20201 Phone: 202 205-2292 FAX: 202 205-4786 E-Mail: andra.wicks@hhs.gov
Title: Individual Access to Protected Health Information Held by CLIA Laboratories Abstract: The Department of Health and Human Services, Office for Civil Rights, will modify the HIPAA Privacy Rule to conform the access provisions to be consistent with new Centers for Medicare & Medicaid Services regulations that will provide for laboratories subject to the Clinical Laboratory Improvements Amendments of 1988 to provide individuals with access to their protected health information. Agenda Stage of Rulemaking: Completed Action Priority: Substantive, Nonsignificant Major: No Unfunded Mandates: No CFR Citation: 45 CFR 164 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: PL 104-191 sec 264 Legal Deadline: None Timetable:
Action Transferred to RIN 0945 -AA01 Date 07/27/2011 FR Cite
Regulatory Flexibility Analysis Required: Undetermined Federalism: No Agency Contact: Andra Wicks Privacy Specialist, Office of Civil Rights
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Department of Health and Human Services Office of the Secretary 200 Independence Avenue SW. Washington , DC 20201 Phone: 202 205-2292 FAX: 202 205-4786 E-Mail: andra.wicks@hhs.gov
Unified Agenda
Title: Nondiscrimination Under the Affordable Care Act Abstract: The Department of Health and Human Services, Office for Civil Rights, will issue rules for covered entities with respect to prohibitions against discrimination on the basis of race, color, national origin, sex, age, and disability, as provided in Section 1557 of the Affordable Care Act. Section 1557 provides certain protections from discrimination by recipients of federal financial assistance, federally conducted programs, and entities established under Title I of the Affordable Care Act. This section also identifies additional forms of federal financial assistance to which the section will apply. Priority: Other Significant Agenda Stage of Rulemaking: Completed Action Major: No Unfunded Mandates: No CFR Citation: None (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: PL 111-148, sec 1557 Legal Deadline: None Timetable:
Regulatory Flexibility Analysis Required: Undetermined Federalism: No Energy Affected: Undetermined Agency Contact: Carole Brown Equal Opportunity Specialist Department of Health and Human Services Office of the Secretary 200 Independence Avenue SW. Washington , DC 20201 Phone: 202 619-0805 E-Mail: carole.brown@hhs.gov
Title: Permanent Certification Program for Health Information Technology; Revisions to ONC-AA Processes Abstract: Under the authority granted to the National Coordinator for Health Information Technology by section 3001(c)(5) of the Public Health Service Act (PHSA) as added by the Health Information Technology for Economic and Clinical Health (HITECH) Act, this rule proposes a process for a potential applicant for ONC-Authorized Certification Body (ONC-ACB) status, or an ONC-ACB seeking to maintain or renew its accreditation, to appeal to the National Coordinator a decision by the ONCApproved Accreditor (ONC-AA) to deny it accreditation. The National Coordinator is also proposing a process to address instances where the ONC-AA engages in improper conduct and/or does not perform its responsibilities under the permanent certification program. Priority: Other Significant Agenda Stage of Rulemaking: Completed Action Unfunded Mandates: No Major: No CFR Citation: 45 CFR 170 (To search for a specific CFR, visit the Code of Federal Regulations ) 180
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Legal Authority: 42 USC 300jj-11 Legal Deadline: None Timetable:
Action NPRM NPRM Comment Period End Final Action
Unified Agenda
Date 05/31/2011 08/01/2011 11/25/2011
FR Cite 76 FR 31272 76 FR 72636
Regulatory Flexibility Analysis Required: No Government Levels Affected: No Federalism: No Agency Contact: Steven Posnack Policy Analyst Department of Health and Human Services Office of the Secretary Office of the National Coordinator for Health Information Technology 200 Independence Avenue SW. Washington , DC 20201 Phone: 202 690-7151
Title: Metadata Standards to Support Nationwide Electronic Health Information Exchange Abstract: This advance notice of proposed rulemaking would propose the adoption of metadata standards to support nationwide electronic health information exchange. The proposed standards serve as first step toward implementing certain recommendations made by the President's Council of Advisors on Science and Technology (PCAST) in a report entitled, "Realizing the Full Potential of Health Information Technology to improve Healthcare for Americans: The Path Forward." Agenda Stage of Rulemaking: Completed Action Priority: Other Significant Major: No Unfunded Mandates: No CFR Citation: 45 CFR 170 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: 42 USC 300jj-14 Legal Deadline: None Timetable:
Action ANPRM ANPRM Comment Period End Merged With 0991 -AB84 Date 08/09/2011 09/23/2011 12/31/2011 FR Cite 76 FR 48769
Regulatory Flexibility Analysis Required: Undetermined Government Levels Affected: Undetermined Federalism: No Energy Affected: No Agency Contact: Steven Posnack Policy Analyst Department of Health and Human Services Office of the Secretary Office of the National Coordinator for Health Information Technology 200 Independence Avenue SW. Washington , DC 20201 Phone: 202 690-7151

181
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Unified Agenda
Title: Modifications to the HIPAA Privacy, Security, Enforcement, and Breach Notification Rules Abstract: The Department of Health and Human Services Office for Civil Rights will issue final rules to modify the HIPAA Privacy, Security, Enforcement, and Breach Notification Rules as necessary to implement the privacy, security, enforcement, and breach notification provisions of Subtitle D of the Health Information Technology for Economic and Clinical Health Act (Title XIII of the American Recovery and Reinvestment Act of 2009), and will modify the HIPAA Privacy Rule as required by section 105 of the Genetic Information Nondiscrimination Act of 2008. Priority: Economically Significant Agenda Stage of Rulemaking: Completed Action Unfunded Mandates: No Major: Yes CFR Citation: 45 CFR 160; 45 CFR 164 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: PL 111-5, secs 13400 to 13410; 42 USC 1320d-9 Legal Deadline:
Action Other Other Other Other Other Source Statutory Statutory Statutory Statutory Statutory Deadline for final GINA rule Deadline for Interim Final Rule on Breach Notification Effective date of certain HITECH privacy, security, and enforcement provisions Effective date of certain HITECH enforcement provisions Description Effective date of certain HITECH enforcement provisions Date 02/18/2009 05/21/2009 08/17/2009 02/18/2010 02/18/2011
Timetable:
Regulatory Flexibility Analysis Required: No Federalism: No Agency Contact: Andra Wicks Privacy Specialist, Office of Civil Rights Department of Health and Human Services Office of the Secretary 200 Independence Avenue SW. Washington , DC 20201 Phone: 202 205-2292 FAX: 202 205-4786 E-Mail: andra.wicks@hhs.gov
Title: Medicare and State Health Care Programs: Fraud and Abuse; Revisions to the Office of Inspector General's Safe Harbors Under the Antikickback Status, Exclusion Authorities, and Civil Monetary Penalty Abstract: This rule would add new, and modify existing, safe harbors under the anti-kickback statute; add new, and revise existing, regulations governing OIG's authority to impose civil money penalties and assessments; add new, and revise existing, regulations governing OIG's exclusion authority in several areas; and codify new exceptions to the beneficiary inducements prohibition. Priority: Substantive, Nonsignificant Agenda Stage of Rulemaking: Completed Action Major: No Unfunded Mandates: No CFR Citation: 42 CFR 1001.952; 42 CFR 1001 and 1002; 42 CFR 1005; 42 CFR 1003.101; 42 CFR 1003; ... (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: PL 100-93, sec 14(a), sec; PL 111-148, sec 3301, sec 6402; PL 108-173, sec 101(eaaa0, sec 949; PL 10533, sec 4331, PL 99-660; PL 107-188; 42 USC 1320a-7a; 42 USC 1395mm; 42 USC 1395w-27; 42 USC 1396b Legal Deadline:
Timetable:
Action Date FR Cite
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Transferred to RIN 0936 -AA02

07/27/2011
Unified Agenda
Regulatory Flexibility Analysis Required: No Federalism: No Agency Contact: Patrice S. Drew Regulations Analyst Department of Health and Human Services Office of the Secretary 330 Independence Avenue SW. Washington , DC 20201 Phone: 202 619-1368 E-Mail: patrice.drew@hhs.gov
Title: Permanent Certification Program for Health Information Technology; Revisions to ONC-AA Processes Abstract: Under the authority granted to the National Coordinator for Health Information Technology (the National Coordinator) by section 3001(c)(5)of the Public Health Service Act (PHSA), this rule would establish a process for addressing instances where the ONC-Approved Accreditor (ONC-AA) engages in improper conduct or does not perform its responsibilities under the permanent certification program. This rule would also address the status of ONC-Authorized Certification Bodies (ONC-ACBs) in instances where there may be a change in the accreditation organization serving as the ONC-AA and clarifies the responsibilities of the new ONC-AA. Agenda Stage of Rulemaking: Completed Action Priority: Other Significant Major: No Unfunded Mandates: No CFR Citation: 42 CFR 170 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: 42 USC 300jj-11 Legal Deadline: None Timetable:
Action NPRM Merged With 0991 -AB77 NPRM Comment Period End Date 05/31/2011 07/10/2011 08/01/2011 FR Cite 76 FR 31272
Regulatory Flexibility Analysis Required: No Government Levels Affected: No Federalism: No Energy Affected: No Agency Contact: Steven Posnack Policy Analyst Department of Health and Human Services Office of the Secretary Office of the National Coordinator for Health Information Technology 200 Independence Avenue SW. Washington , DC 20201 Phone: 202 690-7151
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January 2011 HHS Semiannual Regulatory Agenda

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Regulations.

Friday, January 20, 2012

Friday, January 20, 2012

NAME: Jennifer M. Cannistra, Executive Secretary to the Department

Friday, January 20, 2012

The 251 Regulatory Agendas

Health Resources and Services Administration - Proposed Rule

0906-AA73 0906-AA79 0906-AA84 0906-AA85 0906-AA87 0906-AA95

Health Resources and Services Administration - Final Rule

Health Resources and Services Administration - Long-term Action

0906-AA44 0906-AA89 0906-AA90 0906-AA92 0906-AA93

Health Resources and Services Administration - Completed Action

0906-AA74 0906-AA83 0906-AA91

Food and Drug Administration - PreRule

0910-AF43 0910-AG14 0910-AG43

Friday, January 20, 2012

Food and Drug Administration - Proposed Rule

Food and Drug Administration - Final Rule

0910-AA49 0910-AF26 0910-AF27 0910-AF61 0910-AF81 0910-AF82

Friday, January 20, 2012

Food and Drug Administration - Long-term Action

Food and Drug Administration - Completed Action

0910-AC25 0910-AF32 0910-AF68 0910-AG02 0910-AG39 0910-AG41 0910-AG51

Indian Health Service - Proposed Rule

0917-AA08 0917-AA09 0917-AA10

Centers for Disease Control and Prevention - Proposed Rule

Friday, January 20, 2012

0920-AA21 0920-AA33 0920-AA34 0920-AA37 0920-AA38 0920-AA42 0920-AA46 0920-AA47

Centers for Disease Control and Prevention - Final Rule

0920-AA10 0920-AA23 0920-AA39 0920-AA44 0920-AA45

Centers for Disease Control and Prevention - Long-term Action

Centers for Disease Control and Prevention - Completed Action

National Institutes of Health - Proposed Rule

0925-AA43 0925-AA48 0925-AA55

National Institutes of Health - Final Rule

National Institutes of Health - Completed Action

Friday, January 20, 2012

Substance Abuse and Mental Health Services Administration - Final Rule

Substance Abuse and Mental Health Services Administration - Completed Action

Office of the Inspector General - Proposed Rule

Office of the Inspector General - Final Rule

Office of Assistant Secretary for Health - Proposed Rule

Office of Assistant Secretary for Health - Completed Action

Centers for Medicare & Medicaid Services - Proposed Rule

0938-AO53 0938-AQ13 0938-AQ37 0938-AQ41 0938-AQ58 0938-AQ63 0938-AQ84 0938-AQ85

Friday, January 20, 2012

Centers for Medicare & Medicaid Services - Final Rule

Centers for Medicare & Medicaid Services - Long-term Action

Friday, January 20, 2012

0938-AP32 0938-AP51 0938-AP61 0938-AP96 0938-AQ01 0938-AQ38 0938-AQ57 0938-AQ74 0938-AR24

Centers for Medicare & Medicaid Services - Completed Action

Friday, January 20, 2012

Office of Public Health and Science - Completed Action

Office for Civil Rights - Final Rule

Office for Civil Rights - Long-term Action

Office for Civil Rights - Completed Action

Administration for Children and Families - Proposed Rule

Friday, January 20, 2012

0970-AC42 0970-AC43 0970-AC50 0970-AC52 0970-AC53

Administration for Children and Families - Final Rule

Administration for Children and Families - Completed Action

0970-AC44 0970-AC48 0970-AC49

Administration on Aging - Proposed Rule

Administration on Aging - Completed Action