January 2011 HHS Semiannual Regulatory 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 Department’s submission to the Fiscal Year 2011 Regulatory Plan, required under

Executive Order 12866.

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Regulations.gov Friday, January 20, 2012 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 Agenda’s 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

TitleRegulation Identifier Number

Add Vascularized Composite Allografts to the Definition of Organs Covered by the Rule Governing the Operation of theOrgan Procurement and Transplantation Network (OPTN) 0906-AA73

Countermeasures Injury Compensation Program; Pandemic Influenza Countermeasure Injury Table Amendment forInfluenza Vaccines, Antiviral Drugs, Respiratory Protection/Support Devices, and Diagnostics 0906-AA79

Countermeasures Injury Compensation Program; Smallpox Injury Table Amendment 0906-AA84 Countermeasures Injury Compensation Program; Anthrax Injury Table Amendment 0906-AA85

Elimination of Duplication Between the Healthcare Integrity and Protection Data Bank and the National Practitioner DataBank 0906-AA87

Amendments to the Rule Governing the Operation of the Organ Procurement and Transplantation Network (OPTN) 0906-AA95

Health Resources and Services Administration - Final Rule


Health Center Federal Tort Claims Act (FTCA) Medical Malpractice Program Regulations--Clarification of FTCACoverage for Services Provided to Non-Health Center Patients 0906-AA77

340B Orphan Drug Exclusion 0906-AA94

Health Resources and Services Administration - Long-term Action


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

Health Resources and Services Administration - Completed Action


National Vaccine Injury Compensation Program; Separate Category for Hepatitis A, Influenza, Meningococcal, HumanPapillomavirus Vaccines 0906-AA74

Countermeasures Injury Compensation Program; Administrative Implementation 0906-AA83 Privacy Act; Exempt Record System 0906-AA91

Food and Drug Administration - PreRule


Over-the-Counter (OTC) Drug Review--Sunscreen Products 0910-AF43

Prescription Drug Marketing Act of 1987; Prescription Drug Amendments of 1992; Policies, Requirements, andAdministrative Procedures 0910-AG14

Non-Face-to-Face Sale and Distribution of Tobacco Products and Advertising, Promotion, and Marketing of TobaccoProducts 0910-AG43

Reports of Distribution and Sales Information for Antimicrobial Active Ingredients Used in Food-Producing Animals3


0910-AG45 Requirements for Testing Human Blood Donors for Evidence of Infection Due to Communicable Disease Agents 0910-AG61 General Requirements for Blood, Blood Components, and Blood Derivatives; Donor Notification 0910-AG62

Food and Drug Administration - Proposed Rule


Electronic Submission of Data From Studies Evaluating Human Drugs and Biologics 0910-AC52 Over-the-Counter (OTC) Drug Review--Internal Analgesic Products 0910-AF36 Over-the-Counter (OTC) Drug Review--Topical Antimicrobial Drug Products 0910-AF69 Import Tolerances for Residues of Unapproved New Animal Drugs in Food 0910-AF78 Laser Products; Amendment to Performance Standard 0910-AF87

Proposed Revisions To Implement Portions of Title XI of the Medicare Prescription Drug, Improvement, andModernization Act of 2003 and Other Changes 0910-AF97

Current Good Manufacturing Practice and Hazard Analysis and Risk-Benefit Preventive Controls for Food for Animals 0910-AG10 Over-the-Counter (OTC) Drug Review-Pediatric Dosing for Cough/Cold Products 0910-AG12 New Animal Drugs: Updating Tolerances for Residues in New Animal Drugs in Food 0910-AG17 Electronic Distribution of Content of Labeling for Human Prescription Drug and Biological Products 0910-AG18 Amendment to the Current Good Manufacturing Practice Regulations for Finished Pharmaceuticals--Second Phase 0910-AG20

Amendments to Regulations on Citizen Petitions, Petitions for Stay of Action, and Submission of Documents to Dockets;Implementation of Section 505(q) of the Federal Food, Drug, and Cosmetic Act 0910-AG26

Unique Device Identification 0910-AG31 Produce Safety Regulation 0910-AG35 Hazard Analysis and Risk-Based Preventive Controls 0910-AG36 Additions to the List of Tropical Diseases in Section 524 of the Federal Food, Drug, and Cosmetic Act 0910-AG37

"Tobacco Products" Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family SmokingPrevention and Tobacco Control Act 0910-AG38

Amendment to Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco To ProtectChildren and Adolescents 0910-AG40

Human Subject Protection; Acceptance of Data From Clinical Studies for Medical Devices 0910-AG48 General Hospital and Personal Use Devices: Issuance of Draft Special Controls Guidance for Infusion Pumps 0910-AG54 Requirements for the Testing and Reporting of Tobacco Product Constituents, Ingredients, and Additives 0910-AG59 Foreign Supplier Verification Program 0910-AG64 Accreditation of Third Parties to Conduct Food Safety Audits and for Other Related Purposes 0910-AG66 Amendments to the Current Good Manufacturing Practice Regulations for Finished Pharmaceuticals--Components 0910-AG70 Orphan Drug Regulations 0910-AG72 Use of Symbols in Labeling 0910-AG74 Effective Date of Requirement for Premarket Approval for Two Class III Preamendments Devices 0910-AG78

Requirements for the Submission of Data Needed to Calculate User Fees for Manufacturers and Importers of TobaccoProducts 0910-AG81

Food and Drug Administration - Final Rule


Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs ThatAre Regulated Under a Biologics License Application and Animal Drugs 0910-AA49

Blood Initiative--Revisions to Labeling Requirements for Blood and Blood Components, Including Source Plasma 0910-AF26

Infant Formula: Current Good Manufacturing Practices; Quality Control Procedures; Notification Requirements; Recordsand Reports; and Quality Factors 0910-AF27

Label Requirement for Food That Has Been Refused Admission Into the United States 0910-AF61 Current Good Manufacturing Practice for Combination Products 0910-AF81 Postmarket Safety Reporting for Combination Products 0910-AF82

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Medical Device Reporting; Electronic Submission Requirements 0910-AF86 Electronic Registration and Listing for Devices 0910-AF88 Exceptions or Alternatives To Labeling Requirements for Products Held by the Strategic National Stockpile 0910-AF90 Postmarketing Safety Reports for Human Drug and Biological Products: Electronic Submission Requirements 0910-AF96 Amendments to Sterility Testing Requirements for Biological Products 0910-AG16 Disqualification of a Clinical Investigator 0910-AG49 Food Labeling: Nutrition Labeling for Food Sold in Vending Machines 0910-AG56 Food Labeling: Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments 0910-AG57 Prior Notice of Imported Food 0910-AG65 Administrative Detention of Food for Human or Animal Consumption 0910-AG67 Additional Safeguards for Children in Clinical Investigation of FDA-Regulated Products 0910-AG71 Food Labeling; Gluten-Free Labeling of Foods 0910-AG84

Food and Drug Administration - Long-term Action


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

Blood Initiative--Requirements for Human Blood and Blood Components Intended for Transfusion or for FurtherManufacturing Use 0910-AG87

Food and Drug Administration - Completed Action


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

Indian Health Service - Proposed Rule


Standards for the Planning, Design, Construction and Operation of Health Care and Sanitation Facilities 0917-AA08 Confidentiality of Medical Quality Assurance Records; Qualified Immunity for Participants 0917-AA09 Catastrophic Health Emergency Fund (CHEF) 0917-AA10

Centers for Disease Control and Prevention - Proposed Rule

Regulation 5


Title Identifier Number

Amendments to Specifications for Medical Examinations of Underground Coal Miners 0920-AA21 Inward Leakage Requirements for Respirators 0920-AA33

Public Health Security and Bioterrorism Preparedness and Response Act of 2002; Biennial Review and Republication ofthe Select Agent and Toxin List 0920-AA34

Control of Communicable Diseases: Foreign and Possessions; Proposed Revision of CDC Etiological Agents ImportationRegulations 0920-AA37

Open-Circuit Self-Contained Breathing Apparatus End-of-Service-Time Indicator Performance Requirements 0920-AA38 Amendments to Respirator Certification Fees 0920-AA42 Establishment of Minimum Standards for Birth Certificates 0920-AA46 Establishment of User Fees for Filovirus Testing of Nonhuman Primate Liver Samples 0920-AA47

Centers for Disease Control and Prevention - Final Rule


Approval Tests and Standards for Closed-Circuit Escape Respirators 0920-AA10 Control of Communicable Diseases: Foreign and Possessions Regulations; Nonhuman Primate 0920-AA23

Guidelines for Determining the Probability of Causation Under the Energy Employees Occupational Illness CompensationProgram Act of 2000; Revision of Guidelines for Non-Radiogenic Cancers 0920-AA39

World Trade Center Health Program Requirements for Enrollment, Appeals, Certification of Health Conditions, andReimbursement 0920-AA44

World Trade Center Health Program Requirements for the Addition of New WTC-Related Health Conditions 0920-AA45

Centers for Disease Control and Prevention - Long-term Action


Control of Communicable Diseases: Foreign 0920-AA12 Control of Communicable Diseases: Interstate 0920-AA22

Centers for Disease Control and Prevention - Completed Action


Amendments To Establish Wildland Firefighting Protection Performance Requirements for Approval of RespiratoryProtective Devices 0920-AA36

National Institutes of Health - Proposed Rule


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

National Institutes of Health - Final Rule


Privacy Act Regulation Concerning NIH Records Related to Research Misconduct Proceedings 0925-AA58

National Institutes of Health - Completed Action


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Endowment Program 0925-AA47 NIH Training Grants 0925-AA49

Amendment of Regulation of the Responsibility of Applicants for Promoting Objectivity in Research for Which PHSFunding Is Sought and Responsible Prospective Contractors 0925-AA53

National Institutes of Health Construction Grants 0925-AA57

Substance Abuse and Mental Health Services Administration - Final Rule


Opioid Drugs in Maintenance or Detoxification Treatment of Opiate Addiction 0930-AA14

Substance Abuse and Mental Health Services Administration - Completed Action


Protection and Advocacy for Individuals With Mental Illness 0930-AA15 Community Mental Health Services and Substance Abuse Prevention and Treatment Block Grants 0930-AA16

Office of the Inspector General - Proposed Rule


Medicare and State Health Care Programs: Fraud and Abuse; Revisions to the Office of Inspector General's SafeHarbors Under the Antikickback Status, Exclusion Authorities, and Civil Monetary Penalty 0936-AA02

Office of the Inspector General - Final Rule


Revision to Prohibition on FFP for "Data Mining" by Medicaid Fraud Control Units 0936-AA01

Office of Assistant Secretary for Health - Proposed Rule


Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, andAmbiguity for Investigators 0937-AA02

Office of Assistant Secretary for Health - Completed Action


Public Health Service Standards for the Protection of Research Misconduct Whistleblowers 0937-AA03

Centers for Medicare & Medicaid Services - Proposed Rule


Home and Community-Based State Plan Services Program and Provider Payment Reassignments (CMS-2249-P2) 0938-AO53 Administrative Simplification: Standard Unique Identifier for Health Plans (CMS-0040-P) 0938-AQ13 Medicaid Disproportionate Share Hospital Payments Uninsured Definition (CMS-2315-P) 0938-AQ37 Covered Outpatient Drugs (CMS-2345-P) 0938-AQ41 Reporting and Returning of Overpayments (CMS-6037-P) 0938-AQ58 Payments for Primary Care Services Under the Medicaid Program (CMS-2370-P) 0938-AQ63 Medicare and Medicaid Electronic Health Record Incentive Program--Stage 2 (CMS-0044-P) 0938-AQ84 Administrative Simplification: Compliance: Health Plan Certification (CMS-0037-P) 0938-AQ85

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Policy and Technical Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit Programs forContract Year 2013 (CMS-4157-F) 0938-AQ86

Medicare and Medicaid Programs: Reform of Hospital and Critical Access Hospital Conditions of Participation (CMS-3244-P) 0938-AQ89

Long Term Care: Ethics and Compliance (CMS-3226-P) 0938-AQ93 Regulatory Provisions To Promote Program Efficiency, Transparency, and Burden Reduction (CMS-9070-P) 0938-AQ96

Establishment of Exchange Program Part II; Appeals of Eligibility Determinations and Oversight and Financial Integrity(CMS-9980-P) 0938-AR03

Medicaid Eligibility Changes Under the Affordable Care Act—Part II (CMS-2334-P) 0938-AR04

Proposed Changes to Hospital OPPS and CY 2013 Payment Rates; ASC Payment System and CY 2013 PaymentRates (CMS-1589-P) 0938-AR10

Revisions to Payment Policies Under the Physician Fee Schedule and Part B for CY 2013 (CMS-1590-P) 0938-AR11 Changes to the Hospital Inpatient an Long-Term Care Prospective Payment System for FY 2013 (CMS-1588-P) 0938-AR12 Changes to the End-Stage Renal Disease Prospective Payment System for CY 2013 (CMS-1352-P) 0938-AR13 Hospice Wage Index for FY 2013 (CMS-1434-P) 0938-AR17 Home Health Prospective Payment System Rate for CY 2013 (CMS-1358-P) 0938-AR18 Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities—Update for FY 2013 (CMS-1432-P) 0938-AR20 Prospective Payment System for Inpatient Rehabilitation Facilities for FY 2013 (CMS-1433-P) 0938-AR21 Inpatient Psychiatric Facility Prospective Payment System--Update for Fiscal Year 2013 (CMS-1440-P) 0938-AR22 Disproportionate Share Hospital Payment Reduction (CMS-2367-P) 0938-AR31 Transparency Reports and Reporting of Physician Ownership of Investment Interests (CMS-5060-F) 0938-AR33

Centers for Medicare & Medicaid Services - Final Rule


Medicare Advantage and Prescription Drug Benefit Programs; Payments to Sponsors of Retiree Prescription Drug Plans(CMS-4131-F2) 0938-AP64

Administrative Simplification: Adoption of Standards for Electronic Funds Transfer (EFT) (CMS-0024-IFC) 0938-AQ11

Medicaid and Children's Health Insurance Programs; Disallowance of Claims for FFP and Technical Corrections (CMS-2292-F) 0938-AQ32

Community First Choice Option (CMS-2337-F) 0938-AQ35

Face-to-Face Requirements for Home Health Services; Policy Changes and Clarifications Related to Home Health(CMS-2348-F) 0938-AQ36

Review and Approval Process for Section 1115 Demonstrations (CMS-2325-F) 0938-AQ46

Emergency Medical Treatment and Labor Act: Applicability to Hospital Inpatients and Hospitals with SpecializedCapabilities (CMS-1350-N) 0938-AQ51

Methods for Assuring Access to Covered Medicaid Services (CMS-2328-F) 0938-AQ54 Medicaid Eligibility Expansion Under the Affordable Care Act of 2010 (CMS-2349-F) 0938-AQ62 Establishment of Exchanges and Qualified Health Plans Part I (CMS-9989-F) 0938-AQ67 Uniform Disclosure to Consumers: Benefit Design, Cost Sharing, & Standards for Definitions (CMS-9982-F) 0938-AQ73 Affordable Care Act Waiver for State Innovation; Review and Approval Process (CMS-9987-F) 0938-AQ75 Student Health Insurance Coverage (CMS-9981-F) 0938-AQ95

Administrative Simplification: Adoption of Operating Rules for Electronic Funds Transfer (EFT) and Remittance Advice(RA) (CMS-0028-IFC) 0938-AR01

State Requirements for Exchange--Reinsurance and Risk Adjustments (CMS-9975-F) 0938-AR07

Inpatient Hospital Deductible and Hospital and Extended Care Services Coinsurance Amounts for CY 2013 (CMS-8046-N) 0938-AR14

Part A Premiums for CY 2013 for the Uninsured Aged and for Certain Disabled Individuals Who Have Exhausted OtherEntitlement (CMS-8047-N) 0938-AR15

Part B Monthly Actuarial Rates, Monthly Premium Rates, and Annual Deductible Beginning January 1, 2013 (CMS-8048-N) 0938-AR16

Medicare Shared Savings Program; Final Waivers (CMS-1439-IFC) 0938-AR30

Centers for Medicare & Medicaid Services - Long-term Action

Regulation 8


Title Identifier Number

Requirements for Long-Term Care Facilities: Hospice Services (CMS-3140-F) 0938-AP32 Conditions of Participation (CoPs) for Community Mental Health Centers (CMHCs)(CMS-3202-F) 0938-AP51 Home and Community Based Services Waivers (CMS-2296-F) 0938-AP61 Survey and Enforcement Requirements for Home Health Agencies (CMS-3256-P) 0938-AP96

Changes in Provider and Supplier Enrollment, Ordering and Referring, and Documentation Requirements; and Changesin Provider Agreements (CMS-6010-F) 0938-AQ01

CLIA Programs and HIPAA Privacy Rule; Patients' Access to Laboratory Test Reports (CMS-2319-F) 0938-AQ38

Revisions to Certain Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) Suppliers Safeguards(CMS-6036-F2) 0938-AQ57

Preventive Services Under the Affordable Care Act (CMS-9992-F) 0938-AQ74 Skilled Nursing Facility Required Disclosure of Ownership (CMS-6008-F) 0938-AR24

Centers for Medicare & Medicaid Services - Completed Action


Medicare Changes in Conditions of Participation Requirements and Payment Provisions for Rural Health Clinics andFederally Qualified Health Centers (CMS-1910-F2) 0938-AJ17

Use of Restraints and Seclusion in Residential Treatment Facilities Providing Inpatient Psychiatric Services to IndividualsUnder Age 21 (CMS-2065-F) 0938-AJ96

Medical Improvement Eligibility Group and Definition of Work (CMS-2143-P) 0938-AO10 Optional State Plan Case Management Services (CMS-2237-F) 0938-AO50 Standards for E-Prescribing Under Medicare Part D and the Lifting of the Long Term Care Exemption (CMS-0023-P) 0938-AP49

Limited Changes to the Competitive Acquisition of Durable Medical Equipment, Prosthetics, Orthotics, and Supplies(DMEPOS)(CMS-1561-F) 0938-AP59

Implementing Regulations for Reauthorization of the Children's Health Insurance Program (CHIP) (CMS-2301-P) 0938-AP68 Children's Health Insurance Program (CHIP) Child Enrollment Contingency Fund Payments (CMS-2488-P) 0938-AP71 Ambulatory Surgical Centers Conditions for Coverage: Same-Day Services (CMS-3217-F) 0938-AP93 Charges for Vaccine Administration Under the Vaccines for Children (VFC) Program (CMS-2310-NC) 0938-AP98 Health Care-Related Taxes--Clarification of Definition (CMS-2314-P) 0938-AP99

Changes Affecting Hospital and Critical Access Hospital (CAH) Conditions of Participation (CoPs): Credentialing andPrivileging of Telemedicine Physicians and Practitioners (CMS-3227-F) 0938-AQ05

Long-Term Care Facility Quality Assessment and Performance Improvement Dementia Management and AbusePrevention Training (CMS-3231-P) 0938-AQ10

Administrative Simplification: Adoption of Authoring Organizations for Operating Rules and Adoption of Operating Rulesfor Eligibility and Claims Status (CMS-0032-F) 0938-AQ12

Inpatient Hospital Deductible and Hospital and Extended Care Services Coinsurance Amounts for CY 2012 (CMS-8043-N) 0938-AQ14

Part A Premiums for CY 2012 for the Uninsured Aged and for Certain Disabled Individuals Who Have Exhausted OtherEntitlement (CMS-8044-N) 0938-AQ15

Part B Monthly Actuarial Rates, Monthly Premium Rates, and Annual Deductible Beginning January 1, 2012 (CMS-8045-N) 0938-AQ16

Availability of Medicare Data for Performance Measurement (CMS-5059-F) 0938-AQ17 Medicaid Recovery Audit Contractors (CMS-6034-F) 0938-AQ19 Durable Medical Equipment (DME) Face to Face Encounters and Written Orders Prior to Delivery (CMS-6033-P) 0938-AQ21 Medicare Shared Savings Program: Accountable Care Organizations (CMS-1345-F) 0938-AQ22

Inpatient Psychiatric Facilities Prospective Payment System--Update for Rate Year and Fiscal Year Beginning July 1,2011 (CMS-1346-F) 0938-AQ23

Proposed Changes to the Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and FY 2012 Ratesand to the Long-Term Care Hospital PPS and FY 2012 Rates (CMS-1518-F) 0938-AQ24

Revisions to Payment Policies Under the Physician Fee Schedule and Part B for CY 2012 (CMS-1524-FC) 0938-AQ25

Changes to the Hospital Outpatient Prospective Payment System and Ambulatory Surgical Center Payment System forCY 2012 (CMS-1525-F) 0938-AQ26

End-Stage Renal Disease Prospective Payment System for CY 2012, Quality Incentive Program for PY 2013 and PY2014; Ambulance Fee Schedule; and Durable Medical Equipment (CMS-1577-F) 0938-AQ27

Prospective Payment System for Inpatient Rehabilitation Facilities for FY 2012; Changes in Size of InpatientRehabilitation Units and Inpatient Psychiatric Units (CMS-1349-F) 0938-AQ28

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Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities for FY 2012; Required Disclosures ofOwnership (CMS-1351-F) 0938-AQ29

Home Health Prospective Payment System Refinements and Rate Update for CY 2012 (CMS-1353-F) 0938-AQ30 Hospice Wage Index for FY 2012 (CMS-1355-F) 0938-AQ31 Payment Adjustment for Provider--Preventable Conditions Including Health Care-Acquired Conditions (CMS-2400-F) 0938-AQ34

Medicaid Automated Data System Requirements and Data Elements Necessary for Program Integrity, ProgramOversight, and Administration (CMS-2317-P) 0938-AQ43

HIPAA Mental Health Parity and Addiction Equity Act of 2008 Amendments (CMS-4140-F) 0938-AQ52 Enhanced Federal Funding for Medicaid Eligibility Determination and Enrollment Activities (CMS-2346-F) 0938-AQ53

Medicaid Program; Federal Medical Assistance Percentages (FMAP) for Newly Eligible Mandatory Individuals andExpansion States (CMS-2327-P) 0938-AQ59

Revisions to Medicare Advantage and Part D Prescription Drug Programs; MIPPA-Related Marketing Revisions andAgent/Broker Compensation Plan (CMS-4138-F) 0938-AQ60

Medicaid Program Integrity: Registration of Billing Agents, Clearing Houses, or Other Alternate Payees (CMS-2365-P) 0938-AQ61 Public Use Files of Health Plan Data (CMS-9984-P) 0938-AQ69 Medical Loss Ratios (CMS-9998-FC) 0938-AQ71 Elimination of the Requirement for Termination of Non-Random Prepayment Complex Medical Review (CMS-6022-F2) 0938-AQ83 Five Year Review of Work Relative Value Units Under the Physician Fee Schedule (CMS-1582-PN) 0938-AQ87

Changes to the End-Stage Renal Disease Prospective Payment System Transition Budget-Neutrality Adjustment (CMS-1435-IFC) 0938-AQ94

Establishment of the Consumer Operated and Oriented Plan Program (CMS-9983-F) 0938-AQ98 Changes to the Electronic Prescribing (eRx) Incentive Program for Calendar Year 2011 (CMS-3248-F) 0938-AR00 Clinical Laboratory Fee Schedule; Signature on Requisition (CMS-1436-P) 0938-AR06

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 0938-AR25

Rate Increase Disclosure and Review: Definitions of "Individual Market" and "Small Group Market" (CMS-9999-F) 0938-AR26

Office of Public Health and Science - Completed Action


Public Health Service Standards for the Protection of Research Misconduct Whistleblowers 0940-AA01

Office for Civil Rights - Final Rule


HIPAA Privacy Rule Accounting of Disclosures under the Health Information Technology for Economic and ClinicalHealth Act 0945-AA00

Modifications to the HIPAA Privacy, Security, Enforcement, and Breach Notification Rules 0945-AA03

Office for Civil Rights - Long-term Action


Nondiscrimination Under the Affordable Care Act 0945-AA02

Office for Civil Rights - Completed Action


Individual Access to Protected Health Information Held by CLIA Laboratories 0945-AA01

Administration for Children and Families - Proposed Rule


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Implementation of the Unaccompanied Alien Children (UAC) Provisions of the Trafficking Victims Reauthorization Act of2008 0970-AC42

Performance Standards for Runaway and Homeless Youth Grantees 0970-AC43 Flexibility and Efficiency in Child Support 0970-AC50 Federal Case Registry System of Records Exemption 0970-AC52 Child Care and Development Fund Reforms to Support Child Development and Working Families 0970-AC53

Administration for Children and Families - Final Rule


Tribal Child Welfare 0970-AC41 Head Start Eligibility Determinations 0970-AC46

Administration for Children and Families - Completed Action


Designation Renewal of Head Start Grantees 0970-AC44 Strengthen Medical Support in the Child Support Program 0970-AC48 Improving Payment Processing in the Child Support Enforcement Program 0970-AC49

Administration on Aging - Proposed Rule


Older Americans Act --Ombudsman Program 0985-AA08

Administration on Aging - Completed Action


Community Living Assistance Services and Supports (CLASS) Program--Designation of the CLASS IndependenceBenefit Plan and Enrollment Rules 0985-AA07

Office of the Secretary - PreRule


Governance for a Nationwide Health Information Network 0991-AB83

Office of the Secretary - Proposed Rule


Health Information Technology: New and Revised Standards, Implementation Specifications, and Certification Criteria forElectronic Health Record Technology 0991-AB82

Office of the Secretary - Completed Action


Shared Risk Exception to the Safe Harbor Provisions 0991-AA91 Principles for Determining Costs at Hospitals Under Federal Grants, Contracts, and Cooperative Agreements 0991-AB51

Rescission of Interest Prohibition in the Principles for Determining Costs at Hospitals Under Federal Grants, Contracts,and Cooperative Agreements 0991-AB52

Revision to Prohibition on FFP for "Data Mining" by Medicaid Fraud Control Units 0991-AB61

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HIPAA Privacy Rule Accounting of Disclosures under the Health Information Technology for Economic and ClinicalHealth Act 0991-AB62

Individual Access to Protected Health Information Held by CLIA Laboratories 0991-AB74 Nondiscrimination Under the Affordable Care Act 0991-AB75 Permanent Certification Program for Health Information Technology; Revisions to ONC-AA Processes 0991-AB77 Metadata Standards to Support Nationwide Electronic Health Information Exchange 0991-AB78 Modifications to the HIPAA Privacy, Security, Enforcement, and Breach Notification Rules 0991-AB80

Medicare and State Health Care Programs: Fraud and Abuse; Revisions to the Office of Inspector General's SafeHarbors Under the Antikickback Status, Exclusion Authorities, and Civil Monetary Penalty 0991-AB81

Permanent Certification Program for Health Information Technology; Revisions to ONC-AA Processes 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 theOrgan Procurement and Transplantation Network (OPTN)Abstract: This notice of proposed rulemaking will add vascularized composite allografts (VCA) to the definition of "organs" forpurpose of coverage under NOTA and the OPTN final rule. NOTA authorizes the Secretary to include by regulation, additionalorgans 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 gastrointestinaltract)." VCA transplantation comprises transplants of a variety of body parts (i.e. hand and face transplants) that are notcurrently regulated and which share common characteristics.

Priority: Other Significant Agenda Stage of Rulemaking: Proposed RuleMajor: No Unfunded Mandates: NoCFR 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 PublicHealth Service Act; sec 1138 of the Social Security ActLegal Deadline: None

Timetable: Action Date FR Cite NPRM 12/16/2011 76 FR 78216 NPRM Comment Period End 02/14/2012

Regulatory Flexibility Analysis Required: No Government Levels Affected: NoSmall Entities Affected: No Federalism: NoAgency Contact: Dr. James Bowman Medical Director, Division of TransplantationDepartment of Health and Human ServicesHealth Resources and Services Administration5600 Fishers Lane Room 12C-06Rockville , MD 20857 Phone: 301 443-4861



Title: Countermeasures Injury Compensation Program; Pandemic Influenza Countermeasure Injury Table Amendment forInfluenza Vaccines, Antiviral Drugs, Respiratory Protection/Support Devices, and DiagnosticsAbstract: This proposed rule establishes the Pandemic Influenza Countermeasure Injury Table for Influenza Vaccines, AntiviralMedications, Respiratory Protection Devices, Respiratory Support Devices, and Diagnostics for the Countermeasure InjuryCompensation Program (CICP). The Public Readiness and Emergency Preparedness Act (PREP Act) authorized the Secretaryof HHS to establish the CICP to provide benefits to certain persons who sustain serious physical injury or death as a directresult of the administration or use of covered countermeasures identified by the Secretary in declarations issued under the

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http://www.regulations.gov/public/component/main?main=RuleDocuments&agency=HHS&pubperiod=201110&rin=0906-AA73

http://www.gpoaccess.gov/cfr/retrieve.html


PREP Act. In addition, the Secretary may provide death benefits to certain survivors of individuals who died as a direct result ofcovered injuries or their health complications. One way that an individual who was administered or used a coveredcountermeasure can show that they sustained a covered injury is by demonstrating that they sustained an injury listed on aCountermeasures Injury Table (Table) within the time interval set forth on the Table. This rule will be an amendment to theCICP Administrative Interim Final Rule and will list and explain injuries that, based on compelling, reliable, valid, medical, andscientific evidence, are presumed to be caused by covered Pandemic Influenza Vaccines, Antiviral Medications, RespiratoryProtection Devices, Respiratory Support Devices, and Diagnostics, and set forth the time periods in which the onset of theseinjuries must occur after the administration or use of these covered Pandemic influenza countermeasures.

Priority: Other Significant Agenda Stage of Rulemaking: Proposed RuleMajor: Undetermined Unfunded Mandates: NoCFR 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 ActLegal Deadline: None

Timetable: Action Date FR Cite NPRM 06/00/2012

Regulatory Flexibility Analysis Required: No Government Levels Affected: NoFederalism: NoEnergy Affected: NoAgency Contact: Dr. Vito Caserta Director, Countermeasures Injury Compensation ProgramDepartment of Health and Human ServicesHealth Resources and Services AdministrationHealthcare Systems Bureau Room 11C-26 5600 Fishers LaneRockville , MD 20857 Phone: 301 443-5287 E-Mail: [email protected]



Title: Countermeasures Injury Compensation Program; Smallpox Injury Table AmendmentAbstract: This rule will establish the Smallpox Injury Table for the Countermeasures Injury Compensation Program (CICP). ThePublic Readiness and Emergency Preparedness Act (PREP Act) authorized the Secretary of HHS to establish the CICP toprovide benefits to certain persons who sustain serious physical injury or death as a direct result of the administration or use ofcovered countermeasures identified by the Secretary in declarations issued under the PREP Act. In addition, the Secretary mayprovide death benefits to certain survivors of individuals who died as a direct result of such covered injuries or their healthcomplications. One way that an individual who was administered or used a covered countermeasure can show that they sustaina covered injury is by demonstrating that they sustained an injury listed on a Countermeasures Injury Table (Table) within thetime interval set forth on the Table. This rule will be an amendment to the CICP Administrative Interim Final Rule and will listand explain injuries that, based on compelling, reliable, valid, medical and scientific evidence, are presumed to be caused bycovered smallpox countermeasures, and the time periods in which the onset of these injuries must occur after the administrationor use of these covered smallpox countermeasures.

Priority: Other Significant Agenda Stage of Rulemaking: Proposed RuleMajor: No Unfunded Mandates: NoCFR 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-6eLegal Deadline: None


Regulatory Flexibility Analysis Required: No Government Levels Affected: No13





Federalism: NoEnergy Affected: NoAgency Contact: Dr. Vito Caserta Director, Countermeasures Injury Compensation ProgramDepartment of Health and Human ServicesHealth Resources and Services AdministrationHealthcare Systems Bureau 5600 Fishers Lane Room 11C-26Rockville , MD 20857 Phone: 301 443-5287 E-Mail: [email protected]



Title: Countermeasures Injury Compensation Program; Anthrax Injury Table AmendmentAbstract: This rule will establish the Anthrax Injury Table for the Countermeasures Injury Compensation Program (CICP). ThePublic Readiness and Emergency Preparedness Act (PREP Act) authorized the Secretary of HHS to establish the CICP toprovide benefits to certain persons who sustain serious physical injury or death as a direct result of the administration or use ofcovered countermeasures identified by the Secretary in declarations issued under the PREP Act. In addition, the Secretary mayprovide death benefits to certain survivors of individuals who died as a direct result of such covered injuries or their healthcomplications. One way that an individual who was administered or used a covered countermeasure can show that they sustaina covered injury is by demonstrating that they sustained an injury listed on a Countermeasures Injury Table (Table) within thetime interval set forth on the Table. This rule will be an amendment to the CICP Administrative Interim Final Rule and will listand explain injuries that, based on compelling, reliable, valid, medical and scientific evidence, are presumed to be caused bycovered anthrax countermeasures, and the time periods in which the onset of these injuries must occur after the administrationor use of these covered anthrax countermeasures.

Priority: Other Significant Agenda Stage of Rulemaking: Proposed RuleMajor: No Unfunded Mandates: NoCFR 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-6eLegal Deadline: None


Regulatory Flexibility Analysis Required: No Government Levels Affected: NoFederalism: UndeterminedEnergy Affected: NoAgency Contact: Dr. Vito Caserta Director, Countermeasures Injury Compensation ProgramDepartment of Health and Human ServicesHealth Resources and Services AdministrationHealthcare Systems Bureau 5600 Fishers Lane Room 11C-26Rockville , MD 20857 Phone: 301 443-5287 E-Mail: [email protected]



Title: Elimination of Duplication Between the Healthcare Integrity and Protection Data Bank and the National Practitioner DataBankAbstract: This rule is required under the Affordable Care Act. The purpose is to eliminate the redundant reporting requirements

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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 theHealth 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 arepublished.

Priority: Other Significant Agenda Stage of Rulemaking: Proposed RuleMajor: Undetermined Unfunded Mandates: NoCFR 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 11101Legal Deadline:

Action Source Description Date NPRM Statutory PL 111-148, sec 6403


Regulatory Flexibility Analysis Required: Undetermined Government Levels Affected: NoFederalism: NoAgency Contact: Cynthia Grubbs Director of the Division of Practitioner Data BanksDepartment of Health and Human ServicesHealth Resources and Services Administration5600 Fishers laneRockville , MD 20857 Phone: 301 443-1821 E-Mail: [email protected]



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 andTransplantation Network (OPTN) (42 CFR part 121), which propose amendments on a variety of topics, including protections forliving organ donors, organ allocation, designated transplant program requirements, OPTN policymaking, and data requirements.

Priority: Other Significant Agenda Stage of Rulemaking: Proposed RuleMajor: No Unfunded Mandates: NoCFR 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 ActLegal Deadline: None


Regulatory Flexibility Analysis Required: No Government Levels Affected: NoFederalism: NoEnergy Affected: NoAgency Contact: Emily Levine Special AssistantDepartment of Health and Human ServicesHealth Resources and Services Administration5600 Fishers Lane, Room 4A-53Rockville , MD 20857 Phone: 301 443-3264

15







Title: Health Center Federal Tort Claims Act (FTCA) Medical Malpractice Program Regulations--Clarification of FTCA Coveragefor Services Provided to Non-Health Center PatientsAbstract: This notice of proposed rulemaking proposes to amend regulations at 42 CFR part 6 (FTCA Coverage of CertainGrantees and Individuals) to include additional examples of FTCA covered activities. Recently, questions have arisen regardingthe scope of FTCA regulations as they affect medical malpractice coverage for FTCA deemed health centers and non-healthcenter patients. Section 6.6(e) of the Health Center FTCA Program regulations provides examples of situations within the scopeof section 6.6(d), which authorizes FTCA medical malpractice coverage for non-health center patients. These examples includecertain community-wide interventions and hospital-related activities where the health center's health care practitioners will becovered for services provided to non-health center patients.

Priority: Other Significant Agenda Stage of Rulemaking: Final RuleMajor: No Unfunded Mandates: NoCFR Citation: 42 CFR 6 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: 42 USC 233Legal Deadline: None

Timetable: Action Date FR Cite NPRM 02/28/2011 76 FR 10825 NPRM Comment Period End 04/29/2011 Final Action 05/00/2012

Regulatory Flexibility Analysis Required: No Government Levels Affected: NoSmall Entities Affected: No Federalism: NoEnergy Affected: NoAgency Contact: Suma Nair Director, Office of Quality and Data, Bureau of Primary Health CareDepartment of Health and Human ServicesHealth Resources and Services AdministrationRoom 15C-26 5600 Fishers LaneRockville , MD 20857 Phone: 301 594-0818 E-Mail: [email protected]



Title: 340B Orphan Drug ExclusionAbstract: Under the changes made by section 2302 Health Care and Education Reconciliation Act (Pub. L. 111-152), orphandrugs, when used for the rare condition or disease for which that orphan drug was designated under section 526 of the FederalFood, Drug, and Cosmetic Act (FFDCA), are excluded from the definition of covered outpatient drug for the specified newly-eligible covered entity types for purposes of the 340B Program. This regulatory action details how these exclusions will beimplemented under the 340B Program. The purpose of issuing this proposed rule is to clarify HHS's stated effort in: (1) Providingclarity 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 theAffordable Care Act as intended by Congress.

Priority: Other Significant Agenda Stage of Rulemaking: Final RuleMajor: No Unfunded Mandates: NoCFR 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

16






Act (21 USC 360bb); sec 701(a) FFDC Act (21 USC 371(a)Legal Deadline: None


Regulatory Flexibility Analysis Required: No Government Levels Affected: NoFederalism: NoEnergy Affected: NoAgency Contact: Bradford Lang Public Health Analyst/Health Care System BureauDepartment of Health and Human ServicesHealth Resources and Services Administration5600 Fishers Lane, Room 10c-03Rockville , MD 20857 Phone: 301 443-2671



Title: Designation of Medically Underserved Populations and Health Professional Shortage AreasAbstract: This rulemaking is mandated under the Affordable Care Act. It requires the Secretary to establish a committee todraft an interim final rule for designation of Medically Underserved Populations (MUPs) and Primary Care Health ProfessionsShortage Areas (HPSAs). A notice of intent to form the negotiated rulemaking committee was published on May 21, 2010 (75FR 26167), and the Secretary announced committee membership on July 21, 2010. The rulemaking committee consists oftechnical experts representing stakeholders that will be significantly affected by this rule. A variety of federal and state programstarget resources to underserved populations using MUP and HPSA designations. These designations have not been updated inmany cases for over 20 years and may not reflect current conditions in many areas. The task of the rulemaking committee is toupdate the designations, which will likely involve revisions to the current methodologies to reflect changes in the prevailingvalues 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, butdue to the extensive comments received, another notice was published on June 3, 1999 announcing a decision to develop andpublish a revised NPRM for public comment. The second NPRM was published on February 29, 2008, with the comment periodextended twice (first on April 21, 2008, and again on June 2, 2008). Substantial comments were received. A Federal RegisterNotice published on July 23, 2008, announcing an Agency decision to carefully review these comments, develop a modifiedproposal, and publish another NPRM at a future date.

Priority: Other Significant Agenda Stage of Rulemaking: Long-term ActionMajor: No Unfunded Mandates: NoCFR 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 254eLegal Deadline: None

Timetable: Action Date FR Cite NPRM 09/01/1998 63 FR 46538 NPRM Comment Period End 11/02/1998 Second NPRM 02/29/2008 73 FR 11232 Second NPRM Comment Period Extended 04/21/2008 73 FR 21300 Second NPRM Initial Comment Period End 04/29/2008 Second NPRM Extended Comment Period End 05/29/2008 Second NPRM Second Comment Period Extended 06/02/2008 73 FR 31418 Second NPRM Second Extension of Comment Period End 06/30/2008 NPRM Status 07/23/2008 73 FR 42743 Interim Final Rule 12/00/2012

17




Regulatory Flexibility Analysis Required: No Government Levels Affected: NoFederalism: NoAgency Contact: Andy Jordan Senior Analyst, Office of Shortage Designation, Bureau of Health ProfessionsDepartment of Health and Human ServicesHealth Resources and Services AdministrationRoom 8A-09 Parklawn Building 5600 Fishers LaneRockville , MD 20857 Phone: 301 594-0197 FAX: 301 443-4370E-Mail: [email protected]



Title: 340B Drug Pricing Program; Manufacturer Civil Monetary PenaltiesAbstract: This rulemaking is required under the Affordable Care Act. The purpose is to implement an enhancement to the 340BProgram. It amends section 340B of the Public Health Service Act to impose monetary sanctions (not to exceed $5,000 perinstance) on drug manufacturers who intentionally charge a covered entity (aka "safety net provider") a price above the ceilingprice established under the procedures of the 340B Program.

Priority: Other Significant Agenda Stage of Rulemaking: Long-term ActionMajor: No Unfunded Mandates: NoCFR 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 ActLegal Deadline:

Action Source Description Date Other Statutory ANPRM met deadline 09/20/2010

Timetable: Action Date FR Cite NPRM 00/00/0000 ANPRM 09/20/2010 75 FR 57230 ANPRM Comment Period End 11/19/2010

Regulatory Flexibility Analysis Required: Undetermined Government Levels Affected: NoFederalism: NoEnergy Affected: NoAgency Contact: Bradford Lang Public Health Analyst/Health Care System BureauDepartment of Health and Human ServicesHealth Resources and Services Administration5600 Fishers Lane, Room 10c-03Rockville , MD 20857 Phone: 301 443-2671



Title: 340B Drug Pricing Program; Administrative Dispute Resolution ProcessAbstract: This rulemaking is required under the Affordable Care Act. The purpose is to implement an enhancement to the 340BProgram. This rulemaking establishes an involuntary and binding administrative dispute resolution process to resolve claimsraised by covered entities (aka "safety net providers") that they have been overcharged for drugs purchased under the 340BProgram. This administrative dispute resolution process also is available to drug manufacturers.

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Priority: Other Significant Agenda Stage of Rulemaking: Long-term ActionMajor: No Unfunded Mandates: NoCFR 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 HealthService ActLegal Deadline:

Action Source Description Date Other Statutory Advance Notice 09/20/2010


Regulatory Flexibility Analysis Required: Undetermined Government Levels Affected: NoFederalism: NoEnergy Affected: NoAgency Contact: Bradford Lang Public Health Analyst/Health Care System BureauDepartment of Health and Human ServicesHealth Resources and Services Administration5600 Fishers Lane, Room 10c-03Rockville , MD 20857 Phone: 301 443-2671



Title: 340B Ceiling Price RegulationsAbstract: The purpose of this rulemaking is to implement a new statutory requirement in the Affordable Care Act to developand publish through an appropriate policy or regulation issuance, precisely defined standards and methodology for thecalculation of ceiling prices for purposes of 340B.

Priority: Info./Admin./Other Agenda Stage of Rulemaking: Long-term ActionMajor: Undetermined Unfunded Mandates: NoCFR 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 amendedLegal Deadline: None



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Title: 340B Civil Monetary Penalties for Covered EntitiesAbstract: The purpose of this rulemaking is to implement an enhancement to the 340B Program. It amends section 340B ofthe Public Health Service Act to impose sanctions, in appropriate cases as determined by the Secretary, additional to those towhich covered entities are subject under subsection (a)(5)(D), through one or more of the following actions: (i) Where a coveredentity knowingly and intentionally violates subsection (a)(5)(B), the covered entity shall be required to pay a monetary penalty toa 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 asknowing and intentional, removing the covered entity from the drug discount program under this section and disqualifying theentity from re-entry into such program for a reasonable period of time to be determined by the Secretary; and (iii) referringmatters to appropriate Federal authorities within the Food and Drug Administration, the Office of Inspector General ofDepartment of Health and Human Services, or other Federal agencies for consideration of appropriate action under otherFederal statutes, such as the Prescription Drug Marketing Act (21 U.S.C. 353).

Priority: Info./Admin./Other Agenda Stage of Rulemaking: Long-term ActionMajor: No Unfunded Mandates: NoCFR 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 amendedLegal Deadline: None





Title: National Vaccine Injury Compensation Program; Separate Category for Hepatitis A, Influenza, Meningococcal, HumanPapillomavirus VaccinesAbstract: This notice of proposed rulemaking proposes to change the Vaccine Injury Table (Table) to create separatecategories for hepatitis A, trivalent influenza, meningococcal, and human papillomavirus (HPV) vaccines. When a vaccine isrecommended for routine administration to children by the Centers for Disease Control and Prevention (CDC), and after anexcise 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 taximposed on them. Notices were published informing the public that these four vaccines have been added to the Table underCategory XIII. The next step is that new vaccines are added as their own separate categories, with associatedinjuries/conditions, including the time periods in which the first symptoms or significant aggravation of such injuries/conditionsmust occur, if applicable, once the Secretary goes through the rulemaking process. In the past, such injuries/conditions havebeen added based on extensive scientific reviews of medical literature for adverse events following vaccination. Becausereviews for these vaccines are not expected until 2011 at the earliest, we are proceeding with rulemaking to add these fourvaccines as their own separate categories in order to make clear the four vaccines are covered by the National Vaccine InjuryCompensation 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 ActionMajor: No Unfunded Mandates: NoCFR 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, 42USC CFR 100.3(c)(5)Legal Deadline: None

Timetable: Action Date FR Cite NPRM 09/13/2010 75 FR 176 NPRM Comment Period End 03/14/2011 Final Action 06/22/2011 76 FR 36367

Regulatory Flexibility Analysis Required: No Government Levels Affected: NoSmall Entities Affected: No Federalism: NoEnergy Affected: NoAgency Contact: Dr. Geoffrey S. Evans Director, Division of Vaccine Injury Compensation, Healthcare Systems BureauDepartment of Health and Human ServicesHealth Resources and Services AdministrationRoom 11C-26 5600 Fishers LaneRockville , MD 20857 Phone: 301 443-6593 FAX: 301 443-8196E-Mail: [email protected]



Title: Countermeasures Injury Compensation Program; Administrative ImplementationAbstract: This rule establishes the administrative policies, procedures, and requirements for the Countermeasures InjuryCompensation Program (CICP). The Public Readiness and Emergency Preparedness Act (PREP Act) authorizes the Secretaryof HHS to establish the CICP to provide benefits to certain persons who sustain serious physical injury or death as a directresult of the administration or use of covered countermeasures identified by the Secretary in declarations issued under thePREP Act. In addition, the Secretary may provide death benefits to certain survivors of individuals who died as a direct result ofsuch covered injuries or their health complications.

Priority: Other Significant Agenda Stage of Rulemaking: Completed ActionMajor: No Unfunded Mandates: NoCFR 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-4of the Public Health Service Act, as amended; 42 USC 247d to 6d; 42 USC 247d to 6eLegal Deadline: None

Timetable: Action Date FR Cite Interim Final Rule Effective 10/15/2010 Interim Final Rule 10/15/2010 75 FR 63656 Interim Final Rule Comment Period End 12/14/2010 Final Rule 10/07/2011 76 FR 62306

Regulatory Flexibility Analysis Required: No Government Levels Affected: NoSmall Entities Affected: Business Federalism: NoEnergy Affected: NoAgency Contact: Dr. Vito Caserta

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Director, Countermeasures Injury Compensation ProgramDepartment of Health and Human ServicesHealth Resources and Services AdministrationHealthcare Systems Bureau 5600 Fishers Lane Room 11C-26Rockville , MD 20857 Phone: 301 443-5287 E-Mail: [email protected]



Title: Privacy Act; Exempt Record SystemAbstract: 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 andProtection Data Bank (HIPDB) has an exemption from certain provisions of the Privacy Act. In order to maintain this exemptionfor the HIPDB materials, which are now under the NPDB due to implementation of section 1921 of the Social Security Act (42U.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 ActionMajor: No Unfunded Mandates: NoCFR 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 552aLegal Deadline: None


Regulatory Flexibility Analysis Required: No Government Levels Affected: NoFederalism: NoEnergy Affected: UndeterminedAgency Contact: Elizabeth Rezai-Zedah Department of Health and Human ServicesHealth Resources and Services Administration5600 Fishers Lane, Room 8A-09Rockville , MD 20857 Phone: 301 443-4107 E-Mail: [email protected]

Department of Health and Human Services (HHS) Food and Drug Administration ( FDA ) RIN: 0910-AF43


Title: Over-the-Counter (OTC) Drug Review--Sunscreen ProductsAbstract: The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safeand effective and not misbranded. After a final monograph (i.e., final rule) is issued, only OTC drugs meeting the conditions ofthe monograph, or having an approved new drug application, may be legally marketed. The first of the future actions willaddress the safety of sunscreen active ingredients. The second of the future actions will address active ingredients reviewedunder time and extent applications. The last action addresses combination products containing sunscreen and insect repellentingredients.

Priority: Other Significant Agenda Stage of Rulemaking: PreRuleMajor: No Unfunded Mandates: NoCFR Citation: 21 CFR 201; 21 CFR 310; 21 CFR 330 to 358 (To search for a specific CFR, visit the Code of FederalRegulations )

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http://www.regulations.gov/public/component/main?main=RuleDocuments&agency=HHS&pubperiod=201110&rin=0910-AF43



Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 360; 21 USC 371Legal Deadline: None

Timetable: Action Date FR Cite ANPRM (Sunscreen and Insect Repellent) 02/22/2007 72 FR 7941 ANPRM Comment Period End 05/23/2007 NPRM (UVA/UVB) 08/27/2007 72 FR 49070 NPRM Comment Period End 12/26/2007 ANPRM (Dosage Forms) 06/17/2011 76 FR 35669 NPRM (Effectiveness) 06/17/2011 76 FR 35672 Final Action (UVA/UVB) 06/17/2011 76 FR 35620 ANPRM (Dosage Forms) Comment Period End 09/15/2011 NPRM (Effectiveness) Comment Period End 09/15/2011 ANPRM (Safety) 06/00/2012 NPRM (Time and Extent Applications) 08/00/2012

Regulatory Flexibility Analysis Required: Business Government Levels Affected: Local; StateFederalism: YesRelated RINs: Split From 0910-AA01Agency Contact: David Eng Department of Health and Human ServicesFood and Drug AdministrationCenter for Drug Evaluation and Research WO 22, Room 5487 10903 New Hampshire AvenueSilver Spring , MD 20993 Phone: 301 796-2773 FAX: 301 796-9899E-Mail: [email protected]

Department of Health and Human Services (HHS) Food and Drug Administration ( FDA ) RIN: 0910-AG14


Title: Prescription Drug Marketing Act of 1987; Prescription Drug Amendments of 1992; Policies, Requirements, andAdministrative ProceduresAbstract: Pursuant to section 610 of the Regulatory Flexibility Act, FDA is currently undertaking a review of regulationspromulgated under the Prescription Drug Marketing Act (PDMA) including those contained in 21 CFR part 203 and 21 CFRsections 205.3 and 205.50 (as amended in 64 FR 67762 and 67763). The purpose of this review is to determine whether theregulations in 21 CFR part 203 and 21 CFR sections 205.3 and 205.50 (as amended in 64 FR 67762 and 67763) should becontinued without change, or whether they should be amended or rescinded, consistent with the stated objectives of applicablestatues, 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 FR67762 and 67763); (2) the nature of complaints or comments received from the public concerning the regulations in 21 CFR part203 and 21 CFR sections 205.3 and 205.50 (as amended in 64 FR 67762 and 67763); (3) the complexity of the regulations in21 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 theregulations 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) thedegree to which technology, economic conditions, or other factors have changed in the area affected by the regulations in 21CFR part 203 and 21 CFR sections 205.3 and 205.50 (as amended in 64 FR 67762 and 67763). Last year, FDA extended thecompletion date by one year due to the RxUSA Wholesale, Inc., v. HHS case. Since then, the case has ended and FDAproposed to withdraw section 203.50(a). Therefore, FDA will complete the review by December 2011.

Priority: Other Significant Agenda Stage of Rulemaking: PreRuleMajor: Undetermined Unfunded Mandates: NoCFR Citation: 21 CFR 203; 21 CFR 205.3; 21 CFR 205.50 (To search for a specific CFR, visit the Code of FederalRegulations ) 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 381Legal Deadline:

Action Source Description Date Other Statutory Planned Section 610 Review 12/03/2009

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http://www.regulations.gov/public/component/main?main=RuleDocuments&agency=HHS&pubperiod=201110&rin=0910-AG14



Timetable: Action Date FR Cite Begin Review of Current Regulation 11/24/2008 End Review of Current Regulation 12/00/2011

Regulatory Flexibility Analysis Required: Business;Governmental Jurisdictions; Organizations Government Levels Affected: Federal; Local; State

Federalism: NoEnergy Affected: NoAgency Contact: Howard Muller Office of Regulatory PolicyDepartment of Health and Human ServicesFood and Drug AdministrationCenter for Drug Evaluation and Research WO 51, Room 6234 10903 New Hampshire AvenueSilver Spring , MD 20993-0002 Phone: 301 796-3601 FAX: 301 847-8440E-Mail: pdma610(c)[email protected]



Title: Non-Face-to-Face Sale and Distribution of Tobacco Products and Advertising, Promotion, and Marketing of TobaccoProductsAbstract: This rulemaking will address (1) advertising, promotion, and marketing of tobacco products and (2) sale anddistribution 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 transactionsinclude: (a) Mail-order-e.g., a print ad in a magazine that includes a phone number and/or web address for ordering a tobaccoproduct; and (b) Internet-e.g., standard websites, such as an official website of cigarette brand or company/firm websites.

Priority: Other Significant Agenda Stage of Rulemaking: PreRuleMajor: No Unfunded Mandates: NoCFR 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 ActLegal Deadline:

Action Source Description Date

Other Statutory Sec. 906(d)(4)(A)(i) of the Family Smoking Prevention and TobaccoControl Act

10/01/2011

Timetable: Action Date FR Cite ANPRM 09/09/2011 76 FR 55835 ANPRM Comment Period Extended 12/06/2011 76 FR 76096 ANPRM Comment Period End 01/19/2012

Regulatory Flexibility Analysis Required: Undetermined Government Levels Affected: UndeterminedFederalism: UndeterminedEnergy Affected: UndeterminedInternational Impacts: This regulatory action will be likely to have international trade and investment effects, or otherwise be ofinternational interest.Agency Contact: Beth Buckler Regulatory CounselDepartment of Health and Human ServicesFood and Drug Administration9200 Corporate BoulevardRockville , MD 20850

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Phone: 877 287-1373 FAX: 240 276-3904E-Mail: [email protected]



Title: Reports of Distribution and Sales Information for Antimicrobial Active Ingredients Used in Food-Producing AnimalsAbstract: 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 anantimicrobial agent submit an annual report to the Food and Drug Administration on the amount of each antimicrobial activeingredient in the drug product that is sold or distributed for use in food-producing animals, including information on anydistributor-labeled product. This rulemaking is intended to establish the implementing regulations for this statutory provision. Inaddition, FDA is exploring the establishment of other requirements to provide for the collection of more useful drug distributiondata.

Priority: Substantive, Nonsignificant Agenda Stage of Rulemaking: PreRuleMajor: No Unfunded Mandates: NoCFR 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 Date FR Cite ANPRM 03/00/2012

Regulatory Flexibility Analysis Required: Undetermined Government Levels Affected: NoSmall Entities Affected: Business Federalism: NoAgency Contact: Sharon Benz Department of Health and Human ServicesFood and Drug AdministrationCenter for Veterinary Medicine MPN-4, Room 2648, HFV-220 7529 Standish PlaceRockville , MD 20855 Phone: 240 453-6864 E-Mail: [email protected]



Title: Requirements for Testing Human Blood Donors for Evidence of Infection Due to Communicable Disease AgentsAbstract: FDA is undertaking a review of 21 CFR sections 610.40, 610.41, 610.42, 610.44, 640.67, 640.70, (as amended in 66FR 31146) under section 610 of the Regulatory Flexibility Act. The purpose of this review is to determine whether theregulations in 21 CFR sections 610.40, 610.41, 610.42, 610.44, 640.67, 640.70 (as amended in 66 FR 31146) should becontinued without change, or whether they should be amended or rescinded, consistent with the stated objectives of applicablestatutes, to minimize adverse impacts on a substantial number of small entities. FDA will consider, and is soliciting commentson, the following: (1) The continued need for the rule; (2) the nature of complaints or comments received concerning the rulefrom the public; (3) the complexity of the rule; (4) the extent to which the rule overlaps, duplicates, or conflicts with other Federalrules, and, to the extent feasible, with State and local governmental rules; and (5) the length of time since the rule has beenevaluated or the degree to which technology, economic conditions, or other factors have changed in the area affected by therule.

Priority: Other Significant Agenda Stage of Rulemaking: PreRuleMajor: No Unfunded Mandates: NoCFR 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 USC360h 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






263a; 42 USC 264Legal Deadline: None

Timetable: Action Date FR Cite Begin Review of Current Regulation 06/01/2011 End Review of Current Regulation 12/00/2011

Regulatory Flexibility Analysis Required: Business Government Levels Affected: NoFederalism: NoAgency Contact: Melissa Reisman Regulatory CounselDepartment of Health and Human ServicesFood and Drug AdministrationCenter for Biologics Evaluation and Research Suite 200N (HFM-17) 1401 Rockville PikeRockville , MD 20852 Phone: 301 827-6210



Title: General Requirements for Blood, Blood Components, and Blood Derivatives; Donor NotificationAbstract: 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 CFRsections 606.100(b), 606.160(b) and 630.6 (as amended in 66 FR 31165) should be continued without change, or whether theyshould be amended or rescinded, consistent with the stated objectives of applicable statutes, to minimize adverse impacts on asubstantial number of small entities. FDA will consider, and is soliciting comments on, the following: (1) The continued need forthe 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 Stateand 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: PreRuleMajor: No Unfunded Mandates: NoCFR 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 USC374; 42 USC 216; 42 USC 262; 42 USC 263a; 42 USC 264; ...Legal Deadline: None

Timetable: Action Date FR Cite Begin Review 06/01/2011 End Review 12/00/2011

Regulatory Flexibility Analysis Required: No Government Levels Affected: NoFederalism: NoAgency Contact: Melissa Reisman Regulatory CounselDepartment of Health and Human ServicesFood and Drug AdministrationCenter for Biologics Evaluation and Research Suite 200N (HFM-17) 1401 Rockville PikeRockville , MD 20852 Phone: 301 827-6210

Department of Health and Human Services (HHS) Food and Drug Administration ( FDA ) RIN: 0910-AC52

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Title: Electronic Submission of Data From Studies Evaluating Human Drugs and BiologicsAbstract: The Food and Drug Administration is proposing to amend the regulations governing the format in which clinical studydata 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 datasubmitted for NDAs, BLAs, and ANDAs, and their supplements and amendments, be provided in an electronic format that FDAcan process, review, and archive.

Priority: Economically Significant Agenda Stage of Rulemaking: Proposed RuleMajor: Yes Unfunded Mandates: Private SectorCFR 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 Codeof Federal Regulations ) Legal Authority: 21 USC 355; 21 USC 371; 42 USC 262Legal 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 itsintended use. This determination is based in part on clinical study data and bioequivalence data that are submitted as part ofthe marketing application. Study data submitted to FDA in electronic format have generally been more efficient to process andreview. FDA's proposed rule would address the submission of study data in a standardized electronic format. Electronicsubmission 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 increaseduse 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 andbioequivalence data for human drugs and biologics derives from sections 505 and 701 of the Act (21 U.S.C. 355 and 371) andsection 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 ofstudy data, but not requiring electronic submission of the data in the standardized format. This alternative was rejected becausethe 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 time-period was selected because the Agency believes it would provide ample time for applicants to comply without too long a delayin the effective date. A longer time-period would delay the benefit from the increased efficiencies, such as standardization ofreview 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 theAgency 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 wouldinclude, among other things, the cost of converting data to standard structures, terminology, and cost sets (i.e., purchase ofsoftware to convert data); the cost of submitting electronic data (i.e., purchase of file transfer programs); and the cost ofinstalling and validating the software and training personnel. Additional annual recurring costs may result from softwarepurchases and licensing agreements for use of proprietary terminologies. The proposal could result in many long-term benefitsassociated with reduced time for preparing applications, including reduced preparation costs and faster time to market forbeneficial products. In addition, the proposed rule would improve patient safety through faster, more efficient, comprehensiveand accurate data review, as well as enhanced communication among sponsors and clinicians.

Risks: None.Timetable:

Action Date FR Cite NPRM 03/00/2012

Regulatory Flexibility Analysis Required: Business Government Levels Affected: NoFederalism: NoEnergy Affected: NoAgency Contact: Martha Nguyen Regulatory CounselDepartment of Health and Human ServicesFood and Drug Administration

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http://www.regulations.gov/public/component/main?main=RuleDocuments&agency=HHS&pubperiod=201110&rin=0910-AC52



Center for Drug Evaluation and Research WO 51, Room 6352 10903 New Hampshire AvenueSilver Spring , MD 20993-0002 Phone: 301 796-3471 FAX: 301 847-8440E-Mail: [email protected]



Title: Over-the-Counter (OTC) Drug Review--Internal Analgesic ProductsAbstract: The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safeand effective and not misbranded. After a final monograph (i.e., final rule) is issued, only OTC drugs meeting the conditions ofthe monograph, or having an approved new drug application, may be legally marketed. The first action addressesacetaminophen safety. The second action addresses products marketed for children under 2 years old and weight- and age-based dosing for children's products.

Priority: Other Significant Agenda Stage of Rulemaking: Proposed RuleMajor: No Unfunded Mandates: NoCFR Citation: 21 CFR 201; 21 CFR 310; 21 CFR 330 to 358 (To search for a specific CFR, visit the Code of FederalRegulations ) 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; 21USC 379eLegal Deadline: None

Timetable: Action Date FR Cite NPRM (Amendment) (Required Warnings and Other Labeling) 12/26/2006 71 FR 77314 NPRM Comment Period End 05/25/2007 Final Action (Required Warnings and Other Labeling) 04/29/2009 74 FR 19385 Final Action (Correction) 06/30/2009 74 FR 31177 Final Action (Technical Amendment) 11/25/2009 74 FR 61512 NPRM (Acetaminophen) 06/00/2012 NPRM (Amendment) (Pediatric) 12/00/2012

Regulatory Flexibility Analysis Required: Business Government Levels Affected: Local; StateFederalism: YesRelated RINs: Split From 0910-AA01Agency Contact: Mary Chung Department of Health and Human ServicesFood and Drug AdministrationCenter for Drug Evaluation and Research WO 22, Room 5488 10903 New Hampshire AvenueSilver Spring , MD 20993 Phone: 301 796-0260 FAX: 301 796-9899E-Mail: [email protected]



Title: Over-the-Counter (OTC) Drug Review--Topical Antimicrobial Drug ProductsAbstract: The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safeand effective and not misbranded. After a final monograph (i.e., final rule) is issued, only OTC drugs meeting the conditions ofthe monograph, or having an approved new drug application, may be legally marketed. The first action addresses consumerproducts. The second action addresses testing requirements.

Priority: Economically Significant Agenda Stage of Rulemaking: Proposed Rule

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Major: Yes Unfunded Mandates: NoCFR Citation: 21 CFR 201; 21 CFR 310; 21 CFR 330 to 358 (To search for a specific CFR, visit the Code of FederalRegulations ) Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 360; 21 USC 371Legal Deadline: None

Timetable: Action Date FR Cite Final Action (Food Handlers) 00/00/0000 Final Action (First Aid Antiseptic) 00/00/0000 Final Action (Testing) 00/00/0000 Final Action (Consumer) 00/00/0000 NPRM (Testing) 00/00/0000 NPRM (Food Handlers) 00/00/0000 NPRM (Healthcare) 06/17/1994 59 FR 31402 Comment Period End 12/15/1995 NPRM (Consumer) 04/00/2012

Regulatory Flexibility Analysis Required: Business Government Levels Affected: Local; StateFederalism: YesAgency Contact: David Eng Department of Health and Human ServicesFood and Drug AdministrationCenter for Drug Evaluation and Research WO 22, Room 5487 10903 New Hampshire AvenueSilver Spring , MD 20993 Phone: 301 796-2773 FAX: 301 796-9899E-Mail: [email protected]



Title: Import Tolerances for Residues of Unapproved New Animal Drugs in FoodAbstract: The Food and Drug Administration (FDA) plans to publish a proposed rule related to the implementation of the importtolerances provision of the Animal Drug Availability Act of 1996 (ADAA). The ADAA authorizes FDA to establish tolerances forunapproved new animal drugs where edible portions of animals imported into the United States may contain residues of suchdrugs (import tolerances). It is unlawful to import animal-derived food that bears or contains residues of a new animal drug thatis not approved in the United States, unless FDA has established an import tolerance for that new animal drug and the residueof the new animal drug in the animal-derived food does not exceed that tolerance.

Priority: Substantive, Nonsignificant Agenda Stage of Rulemaking: Proposed RuleMajor: No Unfunded Mandates: NoCFR 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 371Legal Deadline: None

Timetable: Action Date FR Cite NPRM 03/00/2012 NPRM Comment Period End 06/00/2012

Regulatory Flexibility Analysis Required: Business Government Levels Affected: NoFederalism: NoEnergy Affected: NoInternational Impacts: This regulatory action will be likely to have international trade and investment effects, or otherwise be ofinternational interest.Agency Contact: Thomas Moskal Consumer Safety OfficerDepartment of Health and Human Services

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Food and Drug AdministrationCenter for Veterinary Medicine, Room 101 (MPN-4, HFV-232), 7519 Standish PlaceRockville , MD 20855 Phone: 240 276-9242 FAX: 240 276-9241E-Mail: [email protected]



Title: Laser Products; Amendment to Performance StandardAbstract: FDA is proposing to amend the performance standard for laser products to achieve closer harmonization between thecurrent standard and the International Electrotechnical Commission (IEC) standard for laser products and medical laserproducts. 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.

Priority: Other Significant Agenda Stage of Rulemaking: Proposed RuleMajor: No Unfunded Mandates: NoCFR 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 393Legal Deadline: None


Regulatory Flexibility Analysis Required: Business Government Levels Affected: Federal; StateFederalism: YesEnergy Affected: UndeterminedAgency Contact: Nancy Pirt Regulatory CounselDepartment of Health and Human ServicesFood and Drug AdministrationCenter for Devices and Radiological Health WO 66, Room 4438 10903 New Hampshire AvenueSilver Spring , MD 20993 Phone: 301 796-6248 FAX: 301 847-8145E-Mail: [email protected]



Title: Proposed Revisions To Implement Portions of Title XI of the Medicare Prescription Drug, Improvement, andModernization Act of 2003 and Other ChangesAbstract: 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 submitting505(b)(2) applications or ANDAs; (2) the availability of 30-month stays of approval on 505(b)(2) applications and ANDAs thatare 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

30





also would amend certain regulations regarding 505(b)(2) applications and ANDAs to facilitate compliance with and efficientenforcement 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, andsuitability petitions, to facilitate compliance with and efficient enforcement of the Act.

Priority: Other Significant Agenda Stage of Rulemaking: Proposed RuleMajor: Undetermined Unfunded Mandates: NoCFR 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 CFR314.70; 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; 21CFR 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 CFR320.23 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: PL 108-173, title XI; 21 USC 355; 21 USC 371Legal Deadline: None


Regulatory Flexibility Analysis Required: Undetermined Government Levels Affected: NoFederalism: NoAgency Contact: Janice L. Weiner Regulatory CounselDepartment of Health and Human ServicesFood and Drug AdministrationCenter for Drug Evaluation and Research, Office of Regulatory Policy WO 51, Room 6304 10903 New Hampshire AvenueSilver Spring , MD 20993-0002 Phone: 301 796-3601 FAX: 301 847-8440E-Mail: [email protected]



Title: Current Good Manufacturing Practice and Hazard Analysis and Risk-Benefit Preventive Controls for Food for AnimalsAbstract: The Food and Drug Administration (FDA) is proposing regulations for preventive controls for animal feed ingredientsand mixed animal feed to provide greater assurance that marketed animal feed ingredients and mixed feeds intended for allanimals, including pets, are safe. This action is being taken as part of the FDA's Animal Feed Safety System initiative. Thisaction is also being taken to carry out the requirements of the Food and Drug Administration Amendments Act of 2007, undersection 1002(a), and the Food Safety Modernization Act of 2010 (FSMA), under section 103.

Priority: Economically Significant Agenda Stage of Rulemaking: Proposed RuleMajor: Yes Unfunded Mandates: NoCFR 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 111-353Legal Deadline: The legal deadline for FDA under the Food Safety and Modernization Act to promulgate regulations is July2012.


Other Statutory FDA is directed to issue proposed and final regulations under FDAAmendments Act by the statutory deadline.

09/27/2009

Regulatory Plan:Statement of Need: Regulatory oversight of the animal food industry has traditionally been limited and focused on a fewknown safety issues, so there could be potential human and animal health problems that remain unaddressed. The massive petfood recall due to adulteration of pet food with melamine and cyanuric acid in 2007 is a prime example. The actions taken bytwo protein suppliers in China affected a large number of pet food suppliers in the United States and created a nationwideproblem. By the time the cause of the problem was identified, melamine and cyanuric acid contaminated ingredients resulted inthe 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) byadding section 418 (21 U.S.C. 350g) Hazard Analysis and Risk Based Preventive Controls. In enacting FSMA, Congresssought to improve the safety of food in the United States by taking a risk-based approach to food safety, emphasizingprevention. Section 418 of the FD&C Act requires owners, operators, or agents in charge of food facilities to develop andimplement a written plan that describes and documents how their facility will implement the hazard analysis and preventivecontrols 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 byestablishing section 418, which directed FDA to publish implementing regulations. FSMA also amended section 301 of theFD&C Act to add 301(uu) that states the operation of a facility that manufactures, processes, packs, or holds food for sale in theUnited States if the owner, operator, or agent in charge of such facility is not in compliance with section 418 of the FD&C Act isa prohibited act. Further authority comes from section 1002(a) of title X of the FDAAA of 2007 (21 U.S.C. 2102) requiring theSecretary to update standards for the processing of pet food. FDA is also issuing this rule under the general requirements ofsection 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 itsrequirements 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 ingredientsor finished animal food products. Discovering contaminated food ingredients before they are used in a finished product wouldreduce the number of recalls of contaminated animal food products. Benefits would include reduced medical treatment costs foranimals and humans, reduced loss of market value of live animals, reduced loss of animal companionship, and reduced loss invalue of animal food products. More stringent requirements for animal food manufacturing would maintain public confidence inthe safety of animal foods and protect animal and human health. FDA lacks sufficient data to quantify the benefits of theproposed rule. The compliance costs of the proposed rule would result from the additional labor and capital required to performthe hazard analyses, write and implement the preventive controls, monitor and verify the preventive controls, take correctiveactions if preventive controls fail to prevent feeds from becoming contaminated, and implement requirements from theoperations and practices section.

Risks: FDA is proposing this rule to provide greater assurance that food intended for animals is safe and will not cause illnessor injury to animals or humans. This rule would implement a risk-based, preventive controls food safety system intended toprevent animal food containing hazards, which may cause illness or injury to animals or humans, from entering into the foodsupply. The rule would apply to domestic and imported animal food (including raw materials and ingredients). Fewer cases ofanimal food contamination would (1) reduce the risk of serious illness and death to animals, (2) reduce the risk of adversehealth effects to humans handling animal food, and (3) reduce the risk of consuming human food from animals that consumedcontaminated food.Timetable:


Regulatory Flexibility Analysis Required: Business Government Levels Affected: NoFederalism: NoInternational Impacts: This regulatory action will be likely to have international trade and investment effects, or otherwise be ofinternational interest.Agency Contact: Kim Young Deputy Director, Division of ComplianceDepartment of Health and Human ServicesFood and Drug AdministrationCenter for Veterinary Medicine Room 106 (MPN-4, HFV-230) 7519 Standish PlaceRockville , MD 20855 Phone: 240 276-9207 E-Mail: [email protected]



Title: Over-the-Counter (OTC) Drug Review-Pediatric Dosing for Cough/Cold ProductsAbstract: The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safe

32



and effective and not misbranded. After a final monograph (i.e., final rule) is issued, only OTC drugs meeting the conditions ofthe monograph, or having an approved new drug application, may be legally marketed. This action will propose changes to thefinal monograph to address safety and efficacy issues associated with pediatric cough and cold products.

Priority: Economically Significant Agenda Stage of Rulemaking: Proposed RuleMajor: Yes Unfunded Mandates: Private SectorCFR Citation: 21 CFR 201; 21 CFR 310; 21 CFR 330 to 358 (To search for a specific CFR, visit the Code of FederalRegulations ) Legal Authority: 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 360; 21 USC 371Legal Deadline: None


Regulatory Flexibility Analysis Required: Business Government Levels Affected: Local; StateFederalism: YesEnergy Affected: NoInternational Impacts: This regulatory action will be likely to have international trade and investment effects, or otherwise be ofinternational interest.Related RINs: Related to 0910-AF31; Related to 0910-AF32; Related to 0910-AF33; Related to 0910-AF34Agency Contact: Mary Chung Department of Health and Human ServicesFood and Drug AdministrationCenter for Drug Evaluation and Research WO 22, Room 5488 10903 New Hampshire AvenueSilver Spring , MD 20993 Phone: 301 796-0260 FAX: 301 796-9899E-Mail: [email protected]



Title: New Animal Drugs: Updating Tolerances for Residues in New Animal Drugs in FoodAbstract: FDA is proposing to revise 21 CFR 556 to reformat the listings of tolerances for residues of approved new animaldrugs in food. Currently, part 556 employs a patchwork of various styles for listing tolerances that have evolved over the past 40years as each additional animal drug has been approved. The listings in part 556 are not uniform in format, and do not alwaysprovide relevant information in a consistent manner. For example, FDA provides the acceptable daily intake (ADI) and safeconcentrations for some, but not all drugs; FDA lists some tolerances as being for "negligible" residues; and FDA presents somelistings 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. Thisrevision will standardize, simplify, and clarify these listings and improve the readability of the regulations.

Priority: Routine and Frequent Agenda Stage of Rulemaking: Proposed RuleMajor: No Unfunded Mandates: NoCFR 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 371Legal Deadline: None


Regulatory Flexibility Analysis Required: No Government Levels Affected: NoSmall Entities Affected: No Federalism: NoEnergy Affected: NoAgency Contact: Dong Yan

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BiologistDepartment of Health and Human ServicesFood and Drug AdministrationCenter for Veterinary Medicine Room E464 (MPN-2, HFV-151) 7500 Standish PlaceRockville , MD 20855 Phone: 240 276-8117 E-Mail: [email protected]



Title: Electronic Distribution of Content of Labeling for Human Prescription Drug and Biological ProductsAbstract: This rule would require electronic package inserts for human drug and biological prescription products with limitedexception, in lieu of paper, which is currently used. These inserts contain prescribing information intended for healthcarepractitioners. This would ensure that the information accompanying the product is the most up-to-date information regardingimportant safety and efficacy issues about these products.

Priority: Economically Significant Agenda Stage of Rulemaking: Proposed RuleMajor: Yes Unfunded Mandates: Private SectorCFR Citation: 21 CFR 201.100; 21 CFR 201.306; 21 CFR 201.310 (To search for a specific CFR, visit the Code of FederalRegulations ) 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; 42USC 264Legal Deadline: None


Regulatory Flexibility Analysis Required: Business Government Levels Affected: NoFederalism: NoEnergy Affected: NoAgency Contact: Megan Clark-Velez Policy AnalystDepartment of Health and Human ServicesFood and Drug AdministrationOffice of Policy WO Building 32, Room 4249 10903 New Hampshire AvenueSilver Spring , MD 20993 Phone: 301 796-9301 E-Mail: [email protected]



Title: Amendment to the Current Good Manufacturing Practice Regulations for Finished Pharmaceuticals--Second PhaseAbstract: The Food and Drug Administration (FDA) periodically reassesses and revises the cGMP regulations to accommodateadvances in technology and other scientific knowledge that further safeguard the drug manufacturing process and the publichealth. In August 2002, FDA announced the Pharmaceutical cGMPs for the 21st Century Initiative. As part of the Initiative, FDAcreated a cGMP Harmonization Analysis Working Group to analyze related cGMP requirements in the United States andinternationally. The cGMP working group compared 21 CFR parts 210 and 211 with the cGMPs of the European Union, as wellas other FDA regulations (such as the Quality Systems Regulation in 21 CFR part 820) to identify differences and consider thevalue of supplementing or changing the current regulations. Based on the cGMP Working Group's analysis, FDA decided to takean incremental approach to modifying 21 CFR parts 210 and 211. In September of 2008, FDA published a final rule revising thecGMP regulations primarily in the areas of aseptic processing, use of asbestos filters, and verification of operations by a second

34






individual; this final rule represented the culmination of the first increment of modifications to the cGMP regulations. Theproposed 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 RuleMajor: Undetermined Unfunded Mandates: UndeterminedCFR 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 USC262; 42 USC 264Legal Deadline: None


Regulatory Flexibility Analysis Required: Business Government Levels Affected: NoFederalism: NoEnergy Affected: UndeterminedInternational Impacts: This regulatory action will be likely to have international trade and investment effects, or otherwise be ofinternational interest.Agency Contact: S. Mitchell Weitzman Regulatory Counsel, Office of Regulatory PolicyDepartment of Health and Human ServicesFood and Drug AdministrationCenter for Drug Evaluation and Research WO 51, Room 6318 10903 New Hampshire AvenueSilver Spring , MD 20993 Phone: 301 796-3511 FAX: 301 847-8440E-Mail: [email protected]



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 ActAbstract: 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 certainprovisions of section 914 of title IX of the Food and Drug Administration Amendments Act, which added section 505(q) to theFederal Food, Drug, and Cosmetic Act (the Act).

Priority: Other Significant Agenda Stage of Rulemaking: Proposed RuleMajor: No Unfunded Mandates: NoCFR 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 ofFederal Regulations ) Legal Authority: 21 USC 321; 21 USC 505Legal Deadline: None


Regulatory Flexibility Analysis Required: No Government Levels Affected: NoFederalism: NoEnergy Affected: NoAgency Contact: Nicole K. Mueller Regulatory CounselDepartment of Health and Human ServicesFood and Drug Administration

35






Center for Drug Evaluation and Research WO 51, Room 6312 10903 New Hampshire AvenueSilver Spring , MD 20993-0002 Phone: 301 796-3507 FAX: 301 827-8440E-Mail: [email protected]



Title: Unique Device IdentificationAbstract: The Food and Drug Administration Amendments Act of 2007 (FDAAA), amended the Federal Food, Drug, andCosmetic Act by adding section 519(f) (21 U.S.C. 360i(f)). This section requires FDA to promulgate regulations establishing aunique identification system for medical devices requiring the label of medical devices to bear a unique identifier, unless FDAspecifies an alternative placement or provides for exceptions. The unique identifier must adequately identify the device throughdistribution and use, and may include information on the lot or serial number.

Priority: Economically Significant Agenda Stage of Rulemaking: Proposed RuleMajor: Yes Unfunded Mandates: NoCFR 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; 21CFR 822 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: Not Yet DeterminedLegal Deadline: None

Regulatory Plan:Statement of Need: A unique device identification system will help reduce medical errors; will allow FDA, the healthcarecommunity, and industry to more rapidly review and organize adverse event reports; identify problems relating to a particulardevice (even down to a particular lot or batch, range of serial numbers, or range of manufacturing or expiration dates); andthereby 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 of2007) directs the Secretary to promulgate regulations establishing a unique device identification (UDI) system for medicaldevices, requiring the label of devices to bear a unique identifier that will adequately identify the device through its distributionand use.

Alternatives: FDA considered several alternatives that would allow certain requirements of the proposed rule to vary, such asthe 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, includingadministrative costs, to change and print labels that include the required elements of a UDI, costs to purchase equipment toprint and verify the UDI, and costs to purchase software and integrate and validate the UDI into existing IT systems. FDAanticipates that implementation of a UDI system would help improve the efficiency and accuracy of medical device recalls andmedical device adverse event reporting. The proposed rule would also standardize how medical devices are identified andcontribute 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 usedin the Unites States. By providing the means to rapidly and accurately identify a device and key attributes that affect its safeand effective use, the rule would reduce medical errors that result from misidentification of a device or confusion concerning itsappropriate use. The rule will fulfill a statutory directive to establish a unique device identification system.Timetable:


Regulatory Flexibility Analysis Required: Business Government Levels Affected: NoFederalism: UndeterminedEnergy Affected: NoAgency Contact: John J. Crowley Senior Advisor for Patient SafetyDepartment of Health and Human Services

36




Food and Drug AdministrationCenter for Devices and Radiological Health WO 66, Room 2315 10903 New Hampshire AvenueSilver Spring , MD 20993 Phone: 301 980-1936 E-Mail: [email protected]



Title: Produce Safety RegulationAbstract: The Food Safety Modernization Act requires the Secretary to establish and publish science-based minimumstandards for the safe production and harvesting of those types of fruits and vegetables, including specific mixes or categories offruits and vegetables, that are raw agricultural commodities for which the Secretary has determined that such standardsminimize the risk of serious adverse health consequences or death. FDA is proposing to promulgate regulations settingenforceable standards for fresh produce safety at the farm and packing house. The purpose of the proposed rule is to reducethe risk of illness associated with contaminated fresh produce. The proposed rule will be based on prevention-oriented publichealth principles and incorporate what we have learned in the past decade since the Agency issued general good agriculturalpractice 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 draftcommodity specific guidances for tomatoes, leafy greens, and melons. Although the proposed rule will be based onrecommendations that are included in the GAPs guide, FDA does not intend to make the entire guidance mandatory. FDA'sproposed rule would, however, set out clear standards for implementation of modern preventive controls. The proposed rule alsowould emphasize the importance of environmental assessments to identify hazards and possible pathways of contaminationand provide examples of risk reduction practices recognizing that operators must tailor their preventive controls to particularhazards and conditions affecting their operations. The requirements of the proposed rule would be scale appropriate andcommensurate with the relative risks and complexity of individual operations. FDA intends to issue guidance to assist industry incomplying with the requirements of the new regulation.

Priority: Economically Significant Agenda Stage of Rulemaking: Proposed RuleMajor: Yes Unfunded Mandates: Private SectorCFR 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:


NPRM Statutory Proposed rule not later than 12 months after the date of enactment ofthe Food Safety Modernization Act.

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 safetychallenges 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 ofall reported foodborne illness outbreaks. The Agency issued general good agricultural practice guidelines for fresh fruits andvegetables over a decade ago. Incorporating prevention-oriented public heath principles and incorporating what we havelearned in the past decade into a regulation is a critical step in establishing standards for the growing, harvesting, packing, andstoring 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 bysection 105 of the Food Safety Modernization Act (codified primarily in sec. 419 of the FD&C Act (21 U.S.C. 350h)). FDA's legalbasis 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 alsointends to rely on section 361 of the Public Health Service Act (PHS Act) (42 U.S.C. 264), which gives FDA authority topromulgate 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 freshproduce 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 withfresh 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 the37




risks for illness and death associated with foodborne infections associated with the consumption of fresh produce. Lessrestrictive and less comprehensive approaches have not been sufficiently effective in reducing the problems addressed by thisregulation. FDA anticipates that the regulation would lead to a significant decrease in foodborne illness associated with freshproduce consumed in the U.S.Timetable:


Regulatory Flexibility Analysis Required: Business Government Levels Affected: NoFederalism: UndeterminedInternational Impacts: This regulatory action will be likely to have international trade and investment effects, or otherwise be ofinternational interest.Agency Contact: Samir Assar Supervisory Consumer Safety OfficerDepartment of Health and Human ServicesFood and Drug AdministrationCenter for Food Safety and Applied Nutrition Office of Food Safety 5100 Paint Branch ParkwayCollege Park , MD 20740 Phone: 240 402-1636 E-Mail: [email protected]



Title: Hazard Analysis and Risk-Based Preventive ControlsAbstract: The Food and Drug Administration (FDA) Food Safety Modernization Act (the FSMA) requires the Secretary ofHealth and Human Services to promulgate regulations to establish science-based minimum standards for conducting a hazardanalysis, documenting hazards, implementing preventive controls, and documenting the implementation of the preventivecontrols; and to define the terms "small business" and "very small business." The FSMA also requires the Secretary topromulgate regulations with respect to activities that constitute on-farm packing or holding of food that is not grown, raised, orconsumed on a farm or another farm under the same ownership and activities that constitute on farm manufacturing orprocessing of food that is not grown, raised, or consumed on a farm or another farm under the same ownership. FDA isproposing 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 wouldrequire a food facility to have and implement preventive controls to significantly minimize or prevent the occurrence of hazardsthat could affect food manufactured, processed, packed, or held by the facility and to provide assurances that such food will notbe adulterated under section 402 or misbranded under section 403(w).

Priority: Economically Significant Agenda Stage of Rulemaking: Proposed RuleMajor: Yes Unfunded Mandates: NoCFR 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.


Other Statutory Final rule must be published no later than 18 months after the date ofenactment of the FDA Food Safety Modernizaton Act.

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 haveoccurred in the food industry and thereby protect public health. FDA last updated its food CGMP regulations for themanufacturing, packing, or holding of human food in 1986. Modernizing these food CGMP regulations to address risk-basedpreventive controls and more explicitly address issues such as environmental pathogens, food allergens, mandatory employeetraining, and sanitation of food contact surfaces, would be a critical step in raising the standards for food production anddistribution. By amending 21 CFR 110 to modernize good manufacturing practices, the agency could focus the attention of foodprocessors on measures that have been proven to significantly reduce the risk of food-borne illness. An amended regulationalso would allow the agency to better focus its regulatory efforts on ensuring industry compliance with controls that have asignificant 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 the38




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 theFD&C Act, a food is adulterated if it consists in whole or in part of any filthy, putrid, or decomposed substance, or if it isotherwise unfit for food. Under section 402(a)(4), a food is adulterated if it has been prepared, packed, or held under unsanitaryconditions whereby it may have become contaminated with filth or may have been rendered injurious to health. Under section701(a) of the FD&C Act, FDA is authorized to issue regulations for the efficient enforcement of the FD&C Act. FDA's legal basisalso derives from section 361 of the Public Health Service Act (PHS Act) (42 U.S.C. 264), which gives FDA authority topromulgate 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 regulationsto 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 ofprocessed 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 monitoringsuppliers of sensitive raw materials and ingredients, training employees, and completing and maintaining records usedthroughout the facility). FDA anticipates that the benefits would be a reduced risk of food-borne illness and death fromprocessed 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 risksfor illness and death associated with food-borne infections. Less restrictive and less comprehensive approaches have not beeneffective in reducing the problems addressed by this regulation. The regulation will lead to a significant decrease in foodborneillness in the U.S.Timetable:


Regulatory Flexibility Analysis Required: Business Government Levels Affected: NoFederalism: UndeterminedInternational Impacts: This regulatory action will be likely to have international trade and investment effects, or otherwise be ofinternational interest.Agency Contact: John F. Sheehan Director, Office of Food Safety, Division of Plant and Dairy Food SafetyDepartment of Health and Human ServicesFood and Drug AdministrationCenter for Food Safety and Applied Nutrition (HFS-315) 5100 Paint Branch ParkwayCollege Park , MD 20740 Phone: 240 402-1488 FAX: 301 436-2632E-Mail: [email protected]



Title: Additions to the List of Tropical Diseases in Section 524 of the Federal Food, Drug, and Cosmetic ActAbstract: Section 524 of the Federal Food, Drug, and Cosmetic Act (21 USC 360n), "Priority Review to Encourage Treatmentsfor Tropical Diseases," provides authority for the Food and Drug Administration to award to the sponsor of a tropical diseaseproduct application, defined in section 524(a)(4), a priority review voucher, entitling the sponsor to priority review of a singlehuman drug application that is unrelated to the tropical disease product application. The term "tropical disease" means any ofthe diseases listed in section 524(a)(3), and "any other infectious disease for which there is no significant market in developednations and that disproportionately affects poor and marginalized populations, designated by regulation by the Secretary." Theproposed 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 RuleMajor: No Unfunded Mandates: NoCFR Citation: Not Yet Determined (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: 21 USC 360nLegal Deadline: None

Timetable:39





Regulatory Flexibility Analysis Required: No Government Levels Affected: NoSmall Entities Affected: No Federalism: NoEnergy Affected: NoInternational Impacts: This regulatory action will be likely to have international trade and investment effects, or otherwise be ofinternational interest.Agency Contact: Kristiana Brugger Regulatory CounselDepartment of Health and Human ServicesFood and Drug AdministrationCenter for Drug Evaluation and Research 10903 New Hampshire Avenue WO 51, Room 6262Silver Spring , MD 20993 Phone: 301 796-2897 FAX: 301 847-8440E-Mail: [email protected]



Title: "Tobacco Products" Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family SmokingPrevention and Tobacco Control ActAbstract: The Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) provides FDA authority to regulatecigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco. Section 901 of the Federal Food, Drug, andCosmetic Act (FD&C Act), as amended by the Tobacco Control Act, permits FDA to issue regulations deeming other tobaccoproducts to be subject to the FD&C Act. This proposed rule would deem products meeting the statutory definition of "tobaccoproduct" found at section 201(rr) of the FD&C Act to be subject to Chapter IX of the FD&C Act and would clarify additionalrestrictions under the FD&C Act. The scope of the proposed rule deeming cigars that was previously included in the UnifiedAgenda is being broadened to encompass products that meet the statutory definition of "tobacco product."

Priority: Economically Significant Agenda Stage of Rulemaking: Proposed RuleMajor: Yes Unfunded Mandates: UndeterminedCFR 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 Preventionand Tobacco Control ActLegal Deadline: None


Regulatory Flexibility Analysis Required: Business Government Levels Affected: UndeterminedFederalism: UndeterminedInternational Impacts: This regulatory action will be likely to have international trade and investment effects, or otherwise be ofinternational interest.Agency Contact: May Nelson Regulatory CounselDepartment of Health and Human ServicesFood and Drug Administration9200 Corporate BoulevardRockville , MD 20850 Phone: 877 287-1373 FAX: 240 276-3904E-Mail: [email protected]

40






Title: Amendment to Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco To ProtectChildren and AdolescentsAbstract: Section 102 of the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) requires theSecretary to publish a final rule regarding cigarettes and smokeless tobacco identical in its provisions to the regulationspromulgated by FDA in 1996 (61 FR 44396, August 28, 1996) (1996 final rule), with certain specified exceptions. In the re-issued 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 theTobacco 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 manufacturerof a cigarette or smokeless tobacco product with a trade or brand name that is also the trade or brand name of a nontobaccoproduct to continue to use the name if the tobacco product was sold in the United States on or before June 22, 2009. FDA alsois proposing to amend the regulation to ensure that a manufacturer of a cigarette or smokeless tobacco product may continue touse its trade or brand name even if that name is subsequently registered with the United States Patent and Trademark Office orsubsequently used for a nontobacco product.

Priority: Other Significant Agenda Stage of Rulemaking: Proposed RuleMajor: No Unfunded Mandates: NoCFR 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 Preventionand Tobacco Control ActLegal Deadline: None


Regulatory Flexibility Analysis Required: Undetermined Government Levels Affected: NoFederalism: NoRelated RINs: Related to 0910-AG33Agency Contact: Gail L. Schmerfeld Senior Regulatory CounselDepartment of Health and Human ServicesFood and Drug Administration9200 Corporate BoulevardRockville , MD 20850-3229 Phone: 877 287-1373 FAX: 240 276-3904E-Mail: [email protected]



Title: Human Subject Protection; Acceptance of Data From Clinical Studies for Medical DevicesAbstract: The Food and Drug Administration (FDA) is proposing to amend its regulations on acceptance of data from clinicalstudies conducted in support of a premarket approval application, humanitarian device exemption application, an investigationaldevice exemption application, or a premarket notification submission for a medical device.

Priority: Other Significant Agenda Stage of Rulemaking: Proposed RuleMajor: No Unfunded Mandates: NoCFR Citation: Not Yet Determined (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: Not Yet DeterminedLegal Deadline: None

41







Regulatory Flexibility Analysis Required: Business Government Levels Affected: NoFederalism: NoInternational Impacts: This regulatory action will be likely to have international trade and investment effects, or otherwise be ofinternational interest.Agency Contact: Sheila Anne Brown Policy Analyst, Investigational Device Exemptions StaffDepartment of Health and Human ServicesFood and Drug AdministrationWO 66, Room 1651 10903 New Hampshire AvenueSilver Spring , MD 20993 Phone: 301 796-6563 FAX: 301 847-8120E-Mail: [email protected]



Title: General Hospital and Personal Use Devices: Issuance of Draft Special Controls Guidance for Infusion PumpsAbstract: Since 2003, FDA has seen a dramatic increase in the number of device recalls, as well as an increase in the numberof death and serious injury reports submitted regarding infusion pumps. An analysis of the reports reveals that a majority of therecalls and failures were caused by user error and/or device design flaw. As a result of these incidents, FDA is proposing tochange the classification of infusion pumps from class II (performance standards) to class II (special controls). Along with theproposed rule, FDA plans to announce a draft special controls guidance document that, when final, will be a special control forinfusion pumps. The agency believes that establishing these special controls for infusion pumps is necessary to providereasonable assurance of the safety and effectiveness of these devices.

Priority: Other Significant Agenda Stage of Rulemaking: Proposed RuleMajor: Undetermined Unfunded Mandates: NoCFR 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 371Legal Deadline: None


Regulatory Flexibility Analysis Required: Business Government Levels Affected: StateFederalism: YesEnergy Affected: NoAgency Contact: Nancy Pirt Regulatory CounselDepartment of Health and Human ServicesFood and Drug AdministrationCenter for Devices and Radiological Health WO 66 Room 4438 10903 New Hampshire AvenueSilver Spring , MD 20993 Phone: 301 796-6248 FAX: 301 847-8145E-Mail: [email protected]


42





Title: Requirements for the Testing and Reporting of Tobacco Product Constituents, Ingredients, and AdditivesAbstract: Section 915 of the Federal Food, Drug, and Cosmetic Act, as amended by the Family Smoking Prevention andTobacco Control Act, requires FDA to promulgate regulations that require the testing and reporting of tobacco productconstituents, ingredients, and additives, including smoke constituents that the agency determines should be tested to protect thepublic health.

Priority: Other Significant Agenda Stage of Rulemaking: Proposed RuleMajor: Undetermined Unfunded Mandates: UndeterminedCFR 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.


Other Statutory Sec. 915(a) of the Family Smoking Prevention and Tobacco Control Act

04/00/2013


Regulatory Flexibility Analysis Required: Business Government Levels Affected: UndeterminedFederalism: UndeterminedEnergy Affected: NoAgency Contact: Carol Drew Regulatory CounselDepartment of Health and Human ServicesFood and Drug AdministrationRm 240 H 9200 Corporate BoulevardRockville , MD 20850 Phone: 877 287-1373 FAX: 240 276-3904E-Mail: [email protected]



Title: Foreign Supplier Verification ProgramAbstract: The proposed rule would establish regulations concerning the content of foreign supplier verification programs. Theregulations will require that each importer have a foreign supplier verification program that is adequate to provide assurancesthat each foreign supplier produces food in compliance with: (1) Processes and procedures that provide the same level of publichealth protection as those required under section 418 (concerning hazard analysis and risk-based preventative controls) orsection 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, asappropriate, take into account differences among importers and types of imported foods, including differences related to the levelof risk posed by an imported food. Methods of foreign supplier verification may include monitoring records for shipments, lot-by-lot certifications of compliance, annual on-site inspections, checking the hazard analysis and risk-based preventive control plansof foreign suppliers, and periodically testing and sampling shipments.

Priority: Other Significant Agenda Stage of Rulemaking: Proposed RuleMajor: Undetermined Unfunded Mandates: UndeterminedCFR 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 FederalFood, Drug, and Cosmetic Act (FD&C Act)Legal Deadline:


43






Other Statutory 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 aresafe for U.S. consumers. Included among these tools and authorities is a requirement that importers perform risk-based foreignsupplier verification activities to verify that the food they import is produced in compliance with U.S. requirements and is notadulterated or misbranded. This proposed rule on the content of foreign supplier verification program (FSVPs) sets forth theproposed steps that food importers would be required to take to fulfill their responsibility to ensure the safety of the food theybring 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 ofenactment of FSMA, to issue regulations on the content of FSVPs. Section 805(c)(4) states that verification activities undersuch 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 samplingshipments of imported products. Section 301(b) of FSMA amends section 301 of the FD&C Act (21 U.S.C. 331) by addingsection 301(zz), which designates as a prohibited act the importation or offering for importation of a food if the importer (asdefined in section 805) does not have in place an FSVP in compliance with section 805. In addition, section 301(c) of FSMAamends 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 importinto the United States shall be refused admission if it appears from an examination of a sample of such an article or otherwisethat the importer is in violation of section 805.

Alternatives: We are considering a range of alternative approaches to the requirements for foreign supplier verificationactivities. These might include: (1) Establishing a general requirement that importers determine and conduct whateververification activity that would adequately address the risks associated with the foods they import; (2) allowing importers tochoose 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) butallowing flexibility in verification activities for other types of foods or risks; and (4) specifying use of a particular verificationactivity for each particular kind of food or risk. To the extent possible while still ensuring that verification activities are adequateto ensure that foreign suppliers are producing food in accordance with U.S. requirements, we will seek to give importers theflexibility to choose verification procedures that are appropriate to adequately address the risks associated with the importationof a particular food.

Costs and Benefits: We have not yet quantified the cost and benefits for this proposed rule. However, the availableinformation suggests that the costs will be significant. Our preliminary analysis of FY10 OASIS data suggests that this rule willcover about 60,000 importers, 240,000 unique combinations of importers and foreign suppliers, and 540,000 uniquecombinations of importers, products, and foreign suppliers. These numbers imply that provisions that require activity for eachimporter, each unique combination of importer and foreign supplier, or each unique combination of importer, product, andforeign supplier will generate significant costs. An example of a provision linked to combinations of importers and foreignsuppliers would be a requirement to conduct a verification activity, such as an onsite audit, under certain conditions. The cost ofonsite audits will depend in part on whether foreign suppliers can provide the same onsite audit results to different importers orwhether every importer will need to take some action with respect to each of their foreign suppliers. The benefits of thisproposed rule will consist of the reduction of adverse health events linked to imported food that could result from compliancewith 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-riskcommodities. According to recent data from the Centers for Disease Control and Prevention, each year, about 48 millionAmericans 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 imminentthreat. We expect that the adoption of FSVPs by food importers will lead to a significant reduction to the threat to public healthposed by unsafe imported food, though we are still in the process of trying to quantify the reduction in risk that will occurthrough importer compliance with the FSVP regulations.Timetable:


Regulatory Flexibility Analysis Required: Undetermined Government Levels Affected: NoSmall Entities Affected: Business Federalism: NoEnergy Affected: NoInternational Impacts: This regulatory action will be likely to have international trade and investment effects, or otherwise be ofinternational interest.Agency Contact: Brian L. Pendleton

44


Senior Policy AdvisorDepartment of Health and Human ServicesFood and Drug AdministrationOffice of Policy WO32, Room 4245 10903 New Hampshire AvenueSilver Spring , MD 20993-0002 Phone: 301 796-4614 FAX: 301 847-8616E-Mail: [email protected]



Title: Accreditation of Third Parties to Conduct Food Safety Audits and for Other Related PurposesAbstract: The Food and Drug Administration (FDA) is proposing regulations relating to the accreditation of third-party auditorsto conduct food safety audits of foreign entities, including foreign facilities in the food import supply chain. The proposedregulations will include provisions to protect against conflicts of interest between accredited auditors and audited entities, asdescribed 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 conductinglaboratory analyses of food, authorized by other sections of FSMA.

Priority: Other Significant Agenda Stage of Rulemaking: Proposed RuleMajor: No Unfunded Mandates: NoCFR 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 ModernizationAct, as appropriateLegal Deadline: Per Public Law 111-353, section 307(c)(5)(C), promulgate, within 18 months of enactment, implementingregulations for accreditation of third-party auditors to conduct food safety audits.

Action Source Description Date Other Statutory Promulgate implementing regulations 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 safetyof food from foreign origin entering U.S. commerce. Accredited third-party auditors auditing foreign process facilities may beviewed as increasing FDA's "coverage" of foreign facilities that FDA may not have adequate resources to inspect in a particularyear while using identified standards creating overall uniformity to complete the task. Audits that result in issuance of facilitycertificates will provide FDA information about the compliance status of the facility. Additionally, auditors will be required tosubmit 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 bodiesthat accredit third-party auditors, certifying that their eligible entities meet the requirements, directly accredit third-party auditorsshould none be identified and recognized by the 2-year date of enactment, obtain a list of all accredited third-party auditors andtheir agents from recognized accreditation bodies, and determine requirements for regulatory audit reports while avoidingunnecessary 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, asdistinguished from third-party auditors directly accredited by FDA. Another alternative relates to the nature of the requiredstandards 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 enteringU.S. commerce. Additional benefits include the increased flow of credible information to FDA regarding the compliance status offoreign firms and their foods that are ultimately offered for import Into the United States, which information in turn would informFDA's work planning for inspection of foreign food facilities and might result in a signal of possible problems with a particularfirm or its products, and with sufficient signals, might raise questions about the rigor of the food safety regulatory system of thecountry of origin. The compliance costs of the proposed rule would result from the additional labor and capital required ofaccreditation bodies seeking FDA recognition and of third-party auditors seeking accreditation to the extent that will involve theassembling of information for an application unique to the FDA third-party program. The compliance costs associated withcertification will be accounted for separately under the costs associated with participation In the foreign supplier verificationprogram and the costs associated with mandatory certification for high-risk food imports. The third-party program is funded

45




through revenue neutral user fees, which will be developed by FDA through rulemaklng. User fee costs will be accounted for inthat rulemaklng.

Risks: FDA is proposing this rule to provide greater assurance the food offered for import into the United States is safe andwill not cause injury or illness to animals or humans. The rule would implement a program for accrediting third-party auditors toconduct food safety audits of foreign food entities, including registered foreign food facilities, and based on the findings of theregulatory audit, to issue certifications to foreign food entities found to be in compliance with FDA requirements. Thecertifications would be used by importers seeking to participate in the Voluntary Qualified Importer Program for expedited reviewand entry of product and would be a means to provide assurance of compliance as required by FDA based on risk-relatedconsiderations. The rule would apply to any foreign or domestic accreditation body seeking FDA recognition, any foreign ordomestic third-party auditor seeking accreditation, any registered foreign food facility or other foreign food entity subject to afood safety audit (including a regulatory audit conducted for purposes of certification), and any importer seeking to participate inthe Voluntary Qualified Importer Program. Fewer cases of unsafe or misbranded food entering U.S. commerce would reducethe risk of serious illness and death to humans and animals.Timetable:


Regulatory Flexibility Analysis Required: No Government Levels Affected: UndeterminedFederalism: NoEnergy Affected: NoInternational Impacts: This regulatory action will be likely to have international trade and investment effects, or otherwise be ofinternational interest.Agency Contact: Charlotte A. Christin Senior Policy AdvisorDepartment of Health and Human ServicesFood and Drug AdministrationOffice of Policy WO32, Room 4234 10903 New Hampshire AvenueSilver Spring , MD 20993 Phone: 301 796-4718 FAX: 301 847-3541E-Mail: [email protected]



Title: Amendments to the Current Good Manufacturing Practice Regulations for Finished Pharmaceuticals--ComponentsAbstract: This rule proposes to amend regulations regarding the control over components used in manufacturing finishedpharmaceuticals.

Priority: Economically Significant Agenda Stage of Rulemaking: Proposed RuleMajor: Yes Unfunded Mandates: UndeterminedCFR 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 USC262; 42 USC 264Legal Deadline: None


Regulatory Flexibility Analysis Required: Business Government Levels Affected: FederalFederalism: NoInternational Impacts: This regulatory action will be likely to have international trade and investment effects, or otherwise be ofinternational interest.Agency Contact: Brian Hasselbalch Consumer Safety OfficerDepartment of Health and Human Services

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Food and Drug AdministrationCenter for Drug Evaluation and Research WO 51, Room 4364 10903 New Hampshire AvenueSilver Spring , MD 20993 Phone: 301 796-3279 E-Mail: [email protected] Contact: Paula Katz Department of Health and Human ServicesFood and Drug AdministrationCenter for Drug Evaluation and Research WO 51, Room 1320 10903 New Hampshire AvenueSilver Spring , MD 20993 Phone: 301 796-6972 E-Mail: [email protected]



Title: Orphan Drug RegulationsAbstract: FDA is proposing to amend the orphan drug regulations (21 CFR Part 316) to clarify issues that have arisen sincethose regulations were first issued in 1992. These proposed revisions are intended to assist sponsors who are seeking or whohave 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 demonstratingclinical superiority, and the timing of request for designations.

Priority: Substantive, Nonsignificant Agenda Stage of Rulemaking: Proposed RuleMajor: No Unfunded Mandates: NoCFR 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 371Legal Deadline: None


Regulatory Flexibility Analysis Required: No Government Levels Affected: NoSmall Entities Affected: No Federalism: NoAgency Contact: Henry "Chip" Startzman Department of Health and Human ServicesFood and Drug AdministrationWO 32, Room 5280 10903 New Hampshire AvenueSilver Spring , MD 20993 Phone: 301 796-8663 E-Mail: [email protected]



Title: Use of Symbols in LabelingAbstract: 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 ofstandardized symbols recognized by FDA for use on the labeling of medical devices.

Priority: Other Significant Agenda Stage of Rulemaking: Proposed RuleMajor: No Unfunded Mandates: NoCFR 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 USC360d(c), enacted by the Food and Drug Modernization Act of 1997 (FDAMA)

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Legal Deadline: None


Regulatory Flexibility Analysis Required: Undetermined Government Levels Affected: NoFederalism: NoEnergy Affected: NoAgency Contact: Mary Follette Story Department of Health and Human ServicesFood and Drug AdministrationCenter for Devices and Radiological Health Room 2553 10903 New Hampshire AvenueSilver Spring , MD 20993 Phone: 301 796-1456 E-Mail: [email protected]



Title: Effective Date of Requirement for Premarket Approval for Two Class III Preamendments DevicesAbstract: The Food and Drug Administration is proposing to require the filing of a premarket approval application (PMA) or anotice of completion of a product development protocol (PDP) for the following two class III preamendments devices: hip jointmetal/metal semi-constrained, with an uncemented acetabular component, prosthesis.

Priority: Economically Significant Agenda Stage of Rulemaking: Proposed RuleMajor: Yes Unfunded Mandates: NoCFR 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 ActLegal Deadline: None


Regulatory Flexibility Analysis Required: No Government Levels Affected: NoFederalism: NoAgency Contact: Michael Ryan Regulatory AdvisorDepartment of Health and Human ServicesFood and Drug AdministrationWhite Oak, Building 66, Room 1615 10903 New Hampshire AvenueSilver Spring , MD 20993 Phone: 301 796-6283 E-Mail: [email protected]



Title: Requirements for the Submission of Data Needed to Calculate User Fees for Manufacturers and Importers of TobaccoProductsAbstract: Section 919 of the Federal Food, Drug, and Cosmetic Act requires FDA to assess and collect user fees frommanufacturers and importers of certain tobacco products. These user fees are allocated based on the market share of specificclasses of tobacco products and then the market share of individual manufacturers and importers within each class. Section 919requires 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 marketshare 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 tobaccoproducts to provide FDA with certain data that is currently collected by USDA so that FDA will have the ability to directlycalculate market share percentages needed to assess and collect user fees as required in section 919.

Priority: Other Significant Agenda Stage of Rulemaking: Proposed RuleMajor: Undetermined Unfunded Mandates: UndeterminedCFR 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; PL111-31Legal Deadline: None


Regulatory Flexibility Analysis Required: Undetermined Government Levels Affected: NoSmall Entities Affected: Business Federalism: NoEnergy Affected: NoAgency Contact: Annette L. Marthaler Regulatory CounselDepartment of Health and Human ServicesFood and Drug Administration9200 Corporate Boulevard, Room 340KRockville , MD 20850 Phone: 877 287-1373 FAX: 240 276-3904E-Mail: [email protected]

Department of Health and Human Services (HHS) Food and Drug Administration ( FDA ) RIN: 0910-AA49


Title: Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs ThatAre Regulated Under a Biologics License Application and Animal DrugsAbstract: The rule will reorganize, consolidate, clarify, and modify current regulations at 21 CFR part 207 concerning who mustregister establishments and list human drugs, certain biological drugs, and animal drugs. These regulations contain informationon when, how, and where to register drug establishments and list drugs, and what information must be submitted for initialregistration and listing and for changes to registration and listing. They also address National Drug Codes and associatedlabeling.

Priority: Other Significant Agenda Stage of Rulemaking: Final RuleMajor: No Unfunded Mandates: NoCFR 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 CFR610; 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 to360f; 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 262and 264; 42 USC 271Legal Deadline: None


Regulatory Flexibility Analysis Required: No Government Levels Affected: NoSmall Entities Affected: Business Federalism: NoInternational Impacts: This regulatory action will be likely to have international trade and investment effects, or otherwise be of

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international interest.Public Comment URL: www.regulations.govAgency Contact: Sandra Park Regulatory CounselDepartment of Health and Human ServicesFood and Drug AdministrationCenter for Drug Evaluation and Research WO 51, Room 6221 10903 New Hampshire AvenueSilver Spring , MD 20993 Phone: 301 796-0752 FAX: 301 847-8440E-Mail: [email protected]



Title: Blood Initiative--Revisions to Labeling Requirements for Blood and Blood Components, Including Source PlasmaAbstract: The Food and Drug Administration (FDA) is amending the regulations regarding container labels and instructioncirculars for certain human blood and blood components, including Source Plasma, to be more consistent with current practicesand to remove unnecessary or outdated requirements. This action is based on FDA's comprehensive review of the biologicsregulations. It is also based on reports by the U.S. House of Representatives Committee on Government Reform and OversightSubcommittee on House Resources and Intergovernmental Relations, the Government Accountability Office (previously, theGeneral Accounting Office), and the Institute of Medicine, as well as on public comments. This action is intended to help ensurethe continued safety of the blood supply and to help ensure consistency in container labeling. The rule will also consolidate mostof the regulations applicable to labeling standards for blood and blood components, including Source Plasma. For example, mostlabeling requirements for all blood and blood components, including Source Plasma, found previously in 21 CFR 606.121 and 21CFR 640.70, will be found in 21 CFR 606.121.

Priority: Other Significant Agenda Stage of Rulemaking: Final RuleMajor: No Unfunded Mandates: NoCFR 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 to360j; 21 USC 371; 21 USC 374; 21 USC 381; 42 USC 216; 42 USC 262 and 263; 42 USC 263a; 42 USC 264Legal Deadline: None


Regulatory Flexibility Analysis Required: No Government Levels Affected: NoSmall Entities Affected: No Federalism: NoRelated RINs: Split From 0910-AB26Agency Contact: Benjamin Chacko Regulatory CounselDepartment of Health and Human ServicesFood and Drug AdministrationCenter for Biologics Evaluation and Research Suite 200N (HFM-17) 1401 Rockville PikeRockville , MD 20852 Phone: 301 827-6210



Title: Infant Formula: Current Good Manufacturing Practices; Quality Control Procedures; Notification Requirements; Records50





and Reports; and Quality FactorsAbstract: The Food and Drug Administration (FDA) is revising its infant formula regulations in 21 CFR parts 106 and 107 toestablish requirements for current good manufacturing practices (CGMP), including audits; to establish requirements for qualityfactors; 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 RuleMajor: No Unfunded Mandates: NoCFR 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 371Legal Deadline: None

Regulatory Plan:Statement of Need: The Agency published a proposed rule on July 9, 1996, that would establish current good manufacturingpractice regulations, quality control procedures, quality factors, notification requirements, records, and reports for the productionof infant formula. This proposal was issued in response to the 1986 Amendments to the Infant Formula Act of 1980. On April28, 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 CosmeticAct (the Act) to include section 412 (21 U.S.C. 350a). This law is intended to improve protection of infants consuming infantformula products by establishing greater regulatory control over the formulation and production of infant formula. In 1982, FDAadopted infant formula recall procedures in subpart D of 21 CFR part 107 of its regulations (47 FR 18832, Apr. 30, 1982), andinfant formula quality control procedures in subpart B of 21 CFR part 106 (47 FR 17016, Apr. 20, 1982). In 1985, FDA furtherimplemented 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. 99-570) (the 1986 amendments), amended section 412 of the act to address concerns that had been expressed by Congress andconsumers 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 providecertain required nutrients, fails to meet quality factor requirements established by the Secretary (and, by delegation, FDA), or ifit is not processed in compliance with the CGMP and quality control procedures established by the Secretary; (2) require thatthe 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 andquality control procedure regulations; (4) expand the circumstances in which firms must make a submission to the Agency toinclude 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 recallrequirements; and (7) give the Secretary authority to establish requirements for retention of records, including recordsnecessary to demonstrate compliance with CGMP and quality control procedures. In 1989, the Agency implemented theprovisions 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 CFR106.100 (56 FR 66566, Dec. 24, 1991). The Agency has already promulgated regulations that respond to a number of theprovisions 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, requirementsfor 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 yearand recurring costs (e.g., administrative costs, implementation of quality controls, records, audit plans, and assurances of qualityfactors in new infant formulas). FDA anticipates that the primary benefits would be a reduced risk of illness due to Cronobactersakazakii and Salmonella spp in infant formula. Additional benefits stem from the quality factors requirements that would assurethe healthy growth of infants consuming infant formula. Monetized estimates of costs and benefits for this final rule are notavailable at this time. The analysis for the proposed rule estimated costs of less than $1 million per year. FDA was not able toquantify benefits in the analysis for the proposed rule.

Risks: Special controls for infant formula manufacturing are especially important because infant formula, particularly powderedinfant formula, is an ideal medium for bacterial growth and because infants are at high risk of foodborne illness because of theirimmature immune systems. In addition, quality factors are of critical need to assure that the infant formula supports healthygrowth in the first months of life when infant formula may be an infant's sole source of nutrition. The provisions of this rule willaddress weaknesses in production that may allow contamination of infant formula, including, contamination with C. sakazakiiand Salmonella spp which can lead to serious illness with devastating sequelae and/or death. The provisions would also assurethat new infant formulas support healthy growth in infants.

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Timetable: Action Date FR Cite NPRM 07/09/1996 61 FR 36154 NPRM Comment Period End 12/06/1996 NPRM Comment Period Reopened 04/28/2003 68 FR 22341 NPRM Comment Period Extended 06/27/2003 68 FR 38247 NPRM Comment Period End 08/26/2003 NPRM Comment Period Reopened 08/01/2006 71 FR 43392 NPRM Comment Period End 09/15/2006 Final Action 03/00/2012

Regulatory Flexibility Analysis Required: Business Government Levels Affected: NoFederalism: NoEnergy Affected: NoInternational Impacts: This regulatory action will be likely to have international trade and investment effects, or otherwise be ofinternational interest.Related RINs: Split From 0910-AA04Agency Contact: Benson Silverman Department of Health and Human ServicesFood and Drug AdministrationCenter for Food Safety and Applied Nutrition (HFS-850) 5100 Paint Branch ParkwayCollege Park , MD 20740 Phone: 240 402-1459 E-Mail: [email protected]



Title: Label Requirement for Food That Has Been Refused Admission Into the United StatesAbstract: 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 ofunsafe food into the United States, to facilitate the examination of imported food, and to implement section 308 of the PublicHealth Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act) (Pub. L. 107-188).

Priority: Other Significant Agenda Stage of Rulemaking: Final RuleMajor: No Unfunded Mandates: NoCFR 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 USC216; 42 USC 264Legal Deadline: None


Regulatory Flexibility Analysis Required: Business Government Levels Affected: UndeterminedFederalism: NoEnergy Affected: NoInternational Impacts: This regulatory action will be likely to have international trade and investment effects, or otherwise be ofinternational interest.Agency Contact: Daniel Sigelman Regulatory CounselDepartment of Health and Human ServicesFood and Drug AdministrationWO Building 32, Room 4254 10903 New Hampshire AvenueSilver Spring , MD 20993

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Phone: 301 796-4706 E-Mail: [email protected]



Title: Current Good Manufacturing Practice for Combination ProductsAbstract: The final rule is intended to clarify and codify the current good manufacturing practice (cGMP) requirements forcombination products (combinations of a drug, device, and/or biological product). The final rule is intended to ensureconsistency and appropriateness in the regulation of combination products. The final rule will provide a flexible, regulatoryframework that recognizes that, in most instances, for combination products, a properly implemented quality system programunder one set of medical product cGMP regulations will meet the requirements of another set (e.g., application of cGMPs forfinished pharmaceuticals in 21 CFR parts 210 and 211 will generally meet the requirements of the device quality systemregulations in 21 CFR part 820). It would allow manufacturers the flexibility to implement either the drug CGMP or device qualitysystem regulation if both would apply to their manufacture of the combination product, provided that they also incorporateselect, key provisions from the other set of these regulations. It would avoid the necessity to fully implement both sets of cGMPregulations when manufacturing combination products.

Priority: Other Significant Agenda Stage of Rulemaking: Final RuleMajor: No Unfunded Mandates: NoCFR 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 USC360h to 360j; 21 USC 360l; 21 USC 360hh to 360ss; 21 USC 360aaa to 360bbb; 21 USC 371a; 21 USC 372 to 374; 21 USC379e; 21 USC 381; 21 USC 394; 42 USC 216; 42 USC 262; 42 USC 263a; 42 USC 264; 42 USC 271Legal Deadline: None

Timetable: Action Date FR Cite NPRM 09/23/2009 74 FR 48423 NPRM Extension of Comment Period 11/10/2009 74 FR 57973 NPRM Comment Period End 12/22/2009 Final Action 05/00/2012

Regulatory Flexibility Analysis Required: No Government Levels Affected: StateSmall Entities Affected: Business Federalism: YesAgency Contact: John Barlow Weiner Associate Director for PolicyDepartment of Health and Human ServicesFood and Drug AdministrationOffice of Combination Products W032, Room 5130 10903 New Hampshire AvenueSilver Spring , MD 20993 Phone: 301 796-8930 FAX: 301 847-8619E-Mail: [email protected]



Title: Postmarket Safety Reporting for Combination ProductsAbstract: The rule would describe the postmarket safety reporting requirements for combination products (combinations of adrug, device, and/or biological product). The rule would provide a framework for the reporting of adverse events for combinationproducts. The rule would clarify that a combination product is subject primarily to the reporting requirements associated with thetype of marketing application under which the product is approved or cleared. In addition, the rule identifies additional reportingprovisions that must be complied with if applicable. The regulation would ensure the consistency and appropriateness ofpostmarket safety reporting for combination products while minimizing duplicative reporting requirements.

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Priority: Other Significant Agenda Stage of Rulemaking: Final RuleMajor: No Unfunded Mandates: NoCFR 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 USC360h to 360j; 21 USC 360l; 21 USC 360hh to 360ss; 21 USC 360aaa to 360bbb; 21 USC 371a; 21 USC 372 to 374; 21 USC379e; 21 USC 381; 21 USC 394; 42 USC 216; 42 USC 262; 42 USC 263a; 42 USC 264; 42 USC 271Legal Deadline: None


Regulatory Flexibility Analysis Required: No Government Levels Affected: StateSmall Entities Affected: Business Federalism: UndeterminedAgency Contact: John Barlow Weiner Associate Director for PolicyDepartment of Health and Human ServicesFood and Drug AdministrationOffice of Combination Products W032, Room 5130 10903 New Hampshire AvenueSilver Spring , MD 20993 Phone: 301 796-8930 FAX: 301 847-8619E-Mail: [email protected]



Title: Medical Device Reporting; Electronic Submission RequirementsAbstract: The Food and Drug Administration (FDA) is amending its postmarket medical device reporting (MDR) regulations torequire that manufacturers, importers, and user facilities submit mandatory reports of medical device adverse events to theAgency in an electronic format that FDA can process, review, and archive. FDA is taking this action to improve the Agency'ssystems for collecting and analyzing postmarketing safety reports. The proposed change would help the Agency to more quicklyreview safety reports and identify emerging public health issues.

Priority: Economically Significant Agenda Stage of Rulemaking: Final RuleMajor: Yes Unfunded Mandates: NoCFR 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, 374Legal Deadline: None

Regulatory Plan:Statement of Need: The final rule would require user facilities and medical device manufacturers and importers to submitmedical device adverse event reports in electronic format instead of using a paper form. FDA is taking this action to improve itsadverse 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 requireadverse event reports. The final rule would require manufacturers, importers, and user facilities to change their procedures tosend 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 asubstantial number of reporters fail to voluntarily submit electronic MDRs, FDA will not obtain the benefits of standardizedformats and quicker access to medical device adverse event data. The second alternative is to allow small entities more time tocomply. 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 and54





analysis of medical device reports currently submitted annually on paper. In addition, requiring electronic submission wouldreduce FDA annual operating costs and generate industry savings. The one-time costs are for modifying standard operatingprocedures and establishing electronic submission capabilities. Annually recurring costs include maintenance of electronicsubmission capabilities, including renewing the electronic certificate, and for some firms, the incremental cost to maintain high-speed Internet access.

Risks: NoneTimetable:

Action Date FR Cite NPRM 08/21/2009 74 FR 42203 NPRM Comment Period End 11/19/2009 Final Action 03/00/2012

Regulatory Flexibility Analysis Required: No Government Levels Affected: NoFederalism: NoEnergy Affected: NoAgency Contact: Nancy Pirt Regulatory CounselDepartment of Health and Human ServicesFood and Drug AdministrationCenter for Devices and Radiological Health WO 66, Room 4438 10903 New Hampshire AvenueSilver Spring , MD 20993 Phone: 301 796-6248 FAX: 301 847-8145E-Mail: [email protected]



Title: Electronic Registration and Listing for DevicesAbstract: This rule would codify the requirements for electronic registration and listing. However, for those companies that donot have access to the Web, FDA will offer an avenue by which they can register, list, and update information with a papersubmission. The rule also will amend part 807 to reflect the timeframes for device establishment registration and listingestablished by sections 222 and 223 of Food and Drug Administration Amendment Act (FDAAA) and to reflect the requirementin section 510(i) of the Act, as amended by section 321 of the Public Health Security and Bioterrorism Preparedness andResponse Act (BT Act), that foreign establishments provide FDA with additional pieces of information as part of their registration.

Priority: Other Significant Agenda Stage of Rulemaking: Final RuleMajor: No Unfunded Mandates: NoCFR 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 CFRpart 807 to reflect the electronic submission requirements in section 510(p) of the Act, which was added by section 207 ofMDUFMA and later amended by section 224 of FDAAA. FDA also is amending 21 CFR part 807 to reflect the requirements insection 321 of the BT Act for foreign establishments to furnish additional information as part of their registration. This rule willimprove FDA's device establishment registration and listing system and utilize the latest technology in the collection of thisinformation.

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 thenew FDAAA statutory requirements and the advances in data collection and transmission technology, FDA believes thisrulemaking is the preferable alternative.

Costs and Benefits: The Agency believes that there may be some one-time costs associated with the rulemaking, whichinvolve resource costs of familiarizing users with the electronic system. Recurring costs related to submission of the information

55




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 registrationinformation as required by section 321 of the BT Act.

Risks: NoneTimetable:

Action Date FR Cite NPRM 03/26/2010 75 FR 14510 NPRM Comment Period End 06/24/2010 Final Rule 05/00/2012

Regulatory Flexibility Analysis Required: No Government Levels Affected: NoSmall Entities Affected: Business Federalism: NoEnergy Affected: NoAgency Contact: Nancy Pirt Regulatory CounselDepartment of Health and Human ServicesFood and Drug AdministrationCenter for Devices and Radiological Health WO 66, Room 4438 10903 New Hampshire AvenueSilver Spring , MD 20993 Phone: 301 796-6248 FAX: 301 847-8145E-Mail: [email protected]



Title: Exceptions or Alternatives To Labeling Requirements for Products Held by the Strategic National StockpileAbstract: FDA issued regulations to permit FDA Center Directors to grant an exception or alternative to certain regulatorylabeling provisions applicable to human drugs, biological products, or medical devices that are or will be included in the StrategicNational Stockpile (SNS). Under this rule, the appropriate FDA Center Director may grant an exception or alternative to suchlabeling 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 thatare or will be included in the SNS, including not only those that are approved, licensed, or cleared for marketing, but also thosethat are investigational. A grant of an exception or alternative under these regulations will include any safeguards or conditionsdeemed appropriate by the FDA Center Director to ensure that the labeling of such products includes information for the safeand 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 RuleMajor: No Unfunded Mandates: NoCFR 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; 21CFR 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 to264; 42 USC 271Legal Deadline: None

Timetable: Action Date FR Cite Interim Final Rule 12/28/2007 72 FR 73589 Interim Final Rule Comment Period End 03/27/2008 Final Action 02/00/2012

Regulatory Flexibility Analysis Required: No Government Levels Affected: Federal; StateFederalism: YesEnergy Affected: NoAgency Contact: Melissa Reisman

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Regulatory CounselDepartment of Health and Human ServicesFood and Drug AdministrationCenter for Biologics Evaluation and Research Suite 200N (HFM-17) 1401 Rockville PikeRockville , MD 20852 Phone: 301 827-6210



Title: Postmarketing Safety Reports for Human Drug and Biological Products: Electronic Submission RequirementsAbstract: 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 personssubject 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 rulewill allow the Agency to review safety reports more quickly, to identify emerging safety problems, and disseminate safetyinformation more rapidly in support of FDA's public health mission. The amendments would be a key element in harmonizingFDA's postmarketing safety reporting regulations with international and ICH standards for the electronic submission of safetyinformation.

Priority: Other Significant Agenda Stage of Rulemaking: Final RuleMajor: No Unfunded Mandates: NoCFR 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; 21USC 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 Date FR Cite ANPRM 11/05/1998 63 FR 59746 ANPRM Comment Period End 02/03/1999 NPRM 08/21/2009 74 FR 42184 NPRM Comment Period End 11/19/2009 Final Action 03/00/2012

Regulatory Flexibility Analysis Required: Undetermined Government Levels Affected: NoFederalism: NoAgency Contact: Reena Raman Regulatory CounselDepartment of Health and Human ServicesFood and Drug AdministrationCenter for Drug Evaluation and Research WO 51, Room 6238 10903 New Hampshire AvenueSilver Spring , MD 20993-0002 Phone: 301 796-7577 FAX: 301 847-8440E-Mail: [email protected]



Title: Amendments to Sterility Testing Requirements for Biological ProductsAbstract: The Food and Drug Administration (FDA) is issuing a rule to amend the sterility testing requirements for biologicalproducts. This rule is intended to provide manufacturers of biological products greater flexibility and to encourage use of themost 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 RuleMajor: No Unfunded Mandates: NoCFR 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 USC360c; 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 USC262; 42 USC 263; 42 USC 263a; 42 USC 264Legal Deadline: None


Regulatory Flexibility Analysis Required: No Government Levels Affected: NoFederalism: NoAgency Contact: Paul E. Levine Regulatory CounselDepartment of Health and Human ServicesFood and Drug AdministrationCenter for Biologics Evaluation and Research Suite 200N (HFM-17) 1401 Rockville PikeRockville , MD 20852 Phone: 301 827-6210



Title: Disqualification of a Clinical InvestigatorAbstract: The Food and Drug Administration (FDA) is proposing to amend the regulations to expand the scope of clinicalinvestigator disqualification. Under this proposal, when the Commissioner of Food and Drugs determines that an investigator isineligible to receive certain investigational products such as drugs (including biologics), new animal drugs, or devices, theinvestigator also will be ineligible to conduct a clinical investigation that supports an application for a research or marketingpermit for products regulated by the FDA. This proposal is based in part upon recommendations from the GovernmentAccountability Office. Also, this proposal harmonizes existing FDA investigator disqualification regulations. This proposal isintended 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 RuleMajor: No Unfunded Mandates: NoCFR 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 specificCFR, 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


Regulatory Flexibility Analysis Required: No Government Levels Affected: NoFederalism: NoAgency Contact: Kathleen E. Pfaender Senior Health Policy AnalystDepartment of Health and Human ServicesFood and Drug AdministrationWO32-5129 10903 New Hampshire AvenueSilver Spring , MD 20993

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Phone: 301 796-8340 FAX: 301 847-8640E-Mail: [email protected]



Title: Food Labeling: Nutrition Labeling for Food Sold in Vending MachinesAbstract: The Food and Drug Administration (FDA) published a proposed rule in the Federal Register of April 6, 2011 (72 FR19238) to establish requirements for nutrition labeling of certain food items sold in certain vending machines. FDA alsoproposed the terms and conditions for vending machine operators registering to voluntarily be subject to the requirements. FDAtook 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 RuleMajor: Yes Unfunded Mandates: NoCFR 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 371Legal 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 amended403(q)(5) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) by, among other things, creating new clause (H) to requirethat vending machine operators, who own or operate 20 or more machines, disclose calories for certain food items. FDA hasthe 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 DrugAdministration (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 byregulation requirements for calorie labeling of articles of food sold from covered vending machines. Therefore, there are noalternatives to rulemaking. FDA has analyzed alternatives that may reduce the burden of the rulemaking, including analyzingthe benefits and costs of: Restricting the flexibility of the format for calorie disclosure, lengthening the compliance time, andextending 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 coveredby the national standard. It is anticipated that vending machine operators that own or operate 20 or more vending machines willbear costs associated with adding calorie information to vending machines. FDA estimates that the total cost of complying withsection 4205 of the Affordable Care Act and this rulemaking will be approximately $25.8 million initially, with a recurring cost ofapproximately $24 million. Because comprehensive national data for the effects of vending machine labeling do not exist, FDAhas not quantified the benefits associated with section 4205 of the Affordable Care Act and this rulemaking. Some studies haveshown 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 whenconsuming food away from home. Given the very high costs associated with obesity and its associated health risks, FDAestimates that if 0.02 percent of the adult obese population reduces energy intake by at least 100 calories per week, then thebenefits 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 andspend almost half of their food dollars on such foods. This rule will provide consumers with information about the nutritionalcontent of food to enable them to make healthier food choices, and may help mitigate the trend of increasing obesity inAmerica.Timetable:


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Regulatory Flexibility Analysis Required: Business;Governmental Jurisdictions Government Levels Affected: Federal; Local; State

Federalism: YesAgency Contact: Daniel Reese Department of Health and Human ServicesFood and Drug AdministrationCenter for Food Safety and Applied Nutrition (HFS-820) 5100 Paint Branch ParkwayCollege Park , MD 20740 Phone: 240 402-2126 E-Mail: [email protected]



Title: Food Labeling: Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food EstablishmentsAbstract: The Food and Drug Administration (FDA) published a proposed rule in the Federal Register of April 6, 2011 (72 FR19192), to establish requirements for nutrition labeling of standard menu items in chain restaurants and similar retail foodestablishments. FDA also proposed the terms and conditions for restaurants and similar retail food establishments registering tovoluntarily be subject to the Federal requirements. FDA took this action to carry out section 4205 of the Patient Protection andAffordable Care Act ("Affordable Care Act" or "ACA"), which was signed into law on March 23, 2010.

Priority: Economically Significant Agenda Stage of Rulemaking: Final RuleMajor: Yes Unfunded Mandates: Private SectorCFR 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 371Legal 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 theAffordable 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 locationsdisclose 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 veststhe Secretary of Health and Human Services, and, by delegation, the Food and Drug Administration (FDA) with the authority toissue 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 byregulation requirements for nutrition labeling of standard menu items for covered restaurants and similar retail foodestablishments. Therefore, there are no alternatives to rulemaking. FDA has analyzed alternatives that may reduce the burdenof this rulemaking, including analyzing the benefits and costs of expanding and contracting the set of establishmentsautomatically 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 imposedifferent nutrition labeling requirements will benefit from having a uniform national standard. Any restaurant or similar retail foodestablishment with fewer than 20 locations may voluntarily choose to be covered by the national standard. It is anticipated thatchain restaurants with 20 or more locations will bear costs for adding nutrition information to menus and menu boards. FDAestimates 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 over10 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 benefitsassociated with section 4205 of the Affordable Care Act and this rulemaking. Some studies have shown that some consumersconsume fewer calories when menus have information about calorie content displayed. Consumers will benefit from havingimportant nutrition information for the approximately 30 percent of calories consumed away from home. Given the very highcosts associated with obesity and its associated health risks, FDA estimates that if 0.6 percent of the adult obese populationreduces energy intake by at least 100 calories per week, then the benefits of section 4205 of the Affordable Care Act and thisrule 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 spendalmost half of their food dollars on such foods. Unlike packaged foods that are labeled with nutrition information, foods inrestaurants, for the most part, do not have nutrition information that is readily available when ordered. Dietary intake data haveshown that obese Americans consume over 100 calories per meal more when eating food away from home rather than food athome. This rule will provide consumers information about the nutritional content of food to enable them to make healthier foodchoices and may help mitigate the trend of increasing obesity in America.Timetable:


Regulatory Flexibility Analysis Required: Business;Governmental Jurisdictions Government Levels Affected: Federal; Local; State

Federalism: YesAgency Contact: Geraldine A. June Supervisor, Product Evaluation and Labeling TeamDepartment of Health and Human ServicesFood and Drug AdministrationCenter for Food Safety and Applied Nutrition (HFS-820) 5100 Paint Branch ParkwayCollege Park , MD 20740 Phone: 240 402-1802 FAX: 301 436-2636E-Mail: [email protected]



Title: Prior Notice of Imported FoodAbstract: Public Law 111-353, section 304 amends section 801(m) (21 U.S.C. 381(m)) of the Federal Food, Drug, andCosmetic 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, "anycountry to which the article has been refused entry."

Priority: Other Significant Agenda Stage of Rulemaking: Final RuleMajor: No Unfunded Mandates: NoCFR 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 304Legal Deadline:


Other Statutory Public Law 111-353, sec 304 requires the Secretary to issue this interimfinal rule no later than 120 days following the date of enactment of PL111-353.

05/04/2011

Timetable: Action Date FR Cite Interim Final Rule 05/05/2011 76 FR 25542 Interim Final Rule Effective 07/03/2011 Interim Final Rule Comment Period End 08/03/2011 Final Action 08/00/2012

Regulatory Flexibility Analysis Required: No Government Levels Affected: NoSmall Entities Affected: No Federalism: NoEnergy Affected: NoInternational Impacts: This regulatory action will be likely to have international trade and investment effects, or otherwise be ofinternational interest.Agency Contact: Anthony C. Taube Department of Health and Human ServicesFood and Drug Administration

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Office of Regulatory Affairs, Office of Regional Operations 12420 Parklawn Drive, ELEM-4051Rockville , MD 20857 Phone: 866 521-2297 FAX: 703 261-8625E-Mail: [email protected]



Title: Administrative Detention of Food for Human or Animal ConsumptionAbstract: The FDA Food Safety Modernization Act (FSMA) (Pub. L. 111-353) amends the Federal Food, Drug, and CosmeticAct (FD&C Act) with respect to the safety of the food supply. Section 207 of FSMA amends the criteria for orderingadministrative detention of human or animal food in section 304(h)(1)(A) of the FD&C Act. The existing criteria allow the agencyto order the detention of any article of food if during an inspection, examination, or investigation an FDA officer or qualifiedemployee finds there is credible evidence or information indicating that the article of food presents a threat of serious adversehealth consequences or death to humans or animals. Under the new criteria, FDA can order administrative detention if an FDAofficer or qualified employee has reason to believe that an article of food is adulterated or misbranded. Section 207 also requiresthe Secretary to issue an interim final rule implementing this change no later than 120 days following the date of enactment ofFSMA. The interim final rule, issued on May 5, 2011, amended the administrative detention regulations codified at 21 CFR part1, subpart K.

Priority: Substantive, Nonsignificant Agenda Stage of Rulemaking: Final RuleMajor: No Unfunded Mandates: NoCFR 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 USC334(h) and 371(a)).Legal Deadline:


Other Statutory Interim Final Rule to amend 21 CFR part 1, subpart K within 120 daysof the FDA FSMA.

05/04/2011

Timetable: Action Date FR Cite Interim Final Rule 05/05/2011 76 FR 25538 Interim Final Rule Effective 07/03/2011 Interim Final Rule Comment Period End 08/03/2011 Final Action 08/00/2012

Regulatory Flexibility Analysis Required: Undetermined Government Levels Affected: UndeterminedSmall Entities Affected: Business Federalism: NoEnergy Affected: UndeterminedAgency Contact: William A. Correll, Jr. Supervisory Consumer Safety OfficerDepartment of Health and Human ServicesFood and Drug Administration5100 Paint Branch Parkway Room 3C-019, CPK1, HFS-607College Park , MD 20740 Phone: 240 402-1611 FAX: 301 436-2716E-Mail: [email protected]



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 ofthe Children's Health Act of 2000. This rule amends FDA regulation on protection of human subjects (21 CFR Part 50) andinstitutional review boards (21 CFR Part 56) to provide additional safeguards for children enrolled in clinical investigation of FDAregulated trials. Compared to the interim final rule, this final rule makes minor editorial changes and a small number ofsubstantive changes in response to comments received on the interim rule.

Priority: Substantive, Nonsignificant Agenda Stage of Rulemaking: Final RuleMajor: No Unfunded Mandates: NoCFR 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; 42USC 262Legal Deadline: None

Timetable: Action Date FR Cite Interim Final Rule 04/24/2001 66 FR 20589 Final Action 04/00/2012

Regulatory Flexibility Analysis Required: No Government Levels Affected: FederalSmall Entities Affected: No Federalism: NoAgency Contact: Rorbert "Skip" Nelson Department of Health and Human ServicesFood and Drug AdministrationWO 32, Room 5126 10903 New Hampshire AvenueSilver Spring , MD 20993 Phone: 301 796-8665 E-Mail: [email protected]



Title: Food Labeling; Gluten-Free Labeling of FoodsAbstract: Title II of Public Law 108-282 (sec. 206) directed the HHS Secretary to issue a proposed rule by 08/04/2006, and afinal rule by 08/04/2008, to define and permit use of the term "gluten-free" in the labeling of foods. The purpose of thisrulemaking 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 certainstorage proteins, commonly referred to as "gluten," that naturally occur in wheat, rye, barely, and crossbred hybrids of thesegrains (e.g., triticale). Eating foods containing gluten can cause damage to the lining of the small intestine. With continualexposure to gluten, the damage to the small intestine can result in the malabsorption of nutrients, resulting in nutritionaldeficiencies. Persons with celiac disease are also at higher risk of developing other serious disease health problems anddiseases (e.g., growth retardation, short stature, infertility, and intestinal cancers). About 1 percent of the U.S. population isestimated to have celiac disease. FDA issued a proposed rule on gluten-free food labeling on 01/23/07 (72 FR 2795), thatproposed to define the "gluten-free," for voluntary use in the labeling of foods, to mean that the food does not contain: (1) Aningredient that is a species of certain prohibited grains; (2) an ingredient derived from those prohibited grains and that has notbeen processed to remove gluten; (3) an ingredient derived from those prohibited grains and that has been processed toremove 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 asafety 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 announcethe availability of and seek comments on the completed, expert-reviewed safety assessment. FDA is also seeking comments onwhether and, if so, how the safety assessment should affect FDA's definition of "gluten-free" in the final rule, as well as on otherrelated issues.

Priority: Other Significant Agenda Stage of Rulemaking: Final RuleMajor: Undetermined Unfunded Mandates: NoCFR 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 371Legal Deadline:

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Action Source Description Date NPRM Statutory Publication of NPRM 01/23/2007 08/04/2006

Timetable: Action Date FR Cite NPRM 01/23/2007 72 FR 2795 NPRM Comment Period End 04/23/2007 NPRM Comment Period Reopened 08/03/2011 76 FR 46671 NPRM Reopened Comment Period End 10/03/2011 Final Action 11/00/2012

Regulatory Flexibility Analysis Required: No Government Levels Affected: NoSmall Entities Affected: No Federalism: NoEnergy Affected: NoInternational Impacts: This regulatory action will be likely to have international trade and investment effects, or otherwise be ofinternational interest.Agency Contact: Rhonda Rhoda Kane Consumer Safety OfficerDepartment of Health and Human ServicesFood and Drug AdministrationCenter for Food Safety and Applied Nutrition 5100 Paint Branch Parkway Room 4D008, HFS-820College Park , MD 20740 Phone: 240 402-1803 FAX: 301 436-2636E-Mail: [email protected]



Title: Food Labeling; Revision of the Nutrition and Supplement Facts LabelsAbstract: In the Federal Register of July 11, 2003 (68 FR 41507), FDA published an ANPRM (the 2003 ANPRM) to solicitinformation and data on trans fat labeling and claims made about trans fats. Comments received to the 2003 ANPRM thatpertain to the labeling of trans fat will be addressed in this proposed rule. In addition, the Agency published an ANPRM on theprominence of calories on the food label on April 4, 2005 (the 2005 ANPRM) (70 FR 17008), and an ANPRM on the revision ofreference values and mandatory nutrients on November 2, 2007 (the 2007 ANPRM) (72 FR 62149). The Agency also intends toaddress the comments received to the 2005 and 2007 ANPRM's in this proposed rule. FDA is proposing to amend labelingregulations for conventional foods and dietary supplements to provide updated nutrition information on the label to assistconsumers in maintaining healthy dietary practices. Mandatory nutrition labeling of food was first required in 1993. Much of theinformation found on the Nutrition Facts label has not been updated since that time. If finalized, this rule will modernize thenutrition information found on the Nutrition Facts label, as well as the format and appearance of the label. Among the changesproposed, 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 ReferenceIntakes; 2) provide DRVs and RDIs, as well as requirements for foods purported to be for children under 4 years of age andpregnant or lactating women; and 3) make changes to the mandatory declaration of specific nutrients. The Agency is alsoconsidering revisions to the format and appearance of the Nutrition Facts label and the Supplement Facts label, including theprominence of calories on the label.

Priority: Economically Significant Agenda Stage of Rulemaking: Long-term ActionMajor: Yes Unfunded Mandates: UndeterminedCFR 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 371Legal Deadline: None

Timetable: Action Date FR Cite ANPRM 07/11/2003 68 FR 41507 ANPRM Comment Period End 10/09/2003 ANPRM 04/04/2005 70 FR 17008 ANPRM Comment Period End 06/20/2005

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ANPRM 11/02/2007 72 FR 62149 ANPRM Comment Period End 01/31/2008 NPRM 12/00/2012

Regulatory Flexibility Analysis Required: Business;Governmental Jurisdictions Government Levels Affected: Federal; Local

Federalism: YesEnergy Affected: NoInternational Impacts: This regulatory action will be likely to have international trade and investment effects, or otherwise be ofinternational interest.Agency Contact: Blakeley Fitzpatrick Interdisciplinary ScientistDepartment of Health and Human ServicesFood and Drug AdministrationCenter for Food Safety and Applied Nutrition (HFS-830) HFS-830 5100 Paint Branch ParkwayCollege Park , MD 20740 Phone: 240 402-1450 E-Mail: [email protected]



Title: Over-the-Counter (OTC) Drug Review--Oral Health Care ProductsAbstract: The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safeand effective and not misbranded. After a final monograph (i.e., final rule) is issued, only OTC drugs meeting the conditions ofthe monograph, or having an approved new drug application, may be legally marketed. The NPRM and final action will addressoral health care products used to reduce or prevent dental plaque and gingivitis.

Priority: Routine and Frequent Agenda Stage of Rulemaking: Long-term ActionMajor: No Unfunded Mandates: NoCFR Citation: 21 CFR 201; 21 CFR 310; 21 CFR 330 to 358 (To search for a specific CFR, visit the Code of FederalRegulations ) 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 371aLegal Deadline: None

Timetable: Action Date FR Cite NPRM (Benzocaine) 00/00/0000 ANPRM (Plaque Gingivitis) 05/29/2003 68 FR 32232 ANPRM Comment Period End 08/27/2003

Regulatory Flexibility Analysis Required: Business Government Levels Affected: Local; StateFederalism: YesRelated RINs: Split From 0910-AA01Agency Contact: David Eng Department of Health and Human ServicesFood and Drug AdministrationCenter for Drug Evaluation and Research WO 22, Room 5487 10903 New Hampshire AvenueSilver Spring , MD 20993 Phone: 301 796-2773 FAX: 301 796-9899E-Mail: [email protected]



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Title: Use of Materials Derived From Cattle in Human Food and CosmeticsAbstract: On July 14, 2004, FDA issued an interim final rule (IFR), effective immediately, to prohibit the use of certain cattlematerial and to address the potential risk of bovine spongiform encephalopathy (BSE) in human food, including dietarysupplements, and cosmetics. FDA amended the IFR in 2005 and 2008. Prohibited cattle materials under the IFR as amendedinclude specified risk materials, small intestine of all cattle, material from nonambulatory disabled cattle, material from cattle notinspected 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 thethoracic and lumbar vertebrae, and the wings of the sacrum), and dorsal root ganglia of cattle 30 months and older; and thetonsils and distal ileum of the small intestine of all cattle. Prohibited cattle materials do not include tallow that contains no morethan 0.15 percent hexane-insoluble impurities and tallow derivatives, hides and hide derived products, and milk and milkproducts. This action minimizes human exposure to materials that scientific studies have demonstrated are highly likely tocontain the BSE agent in cattle infected with the disease. Scientists believe that the human disease variant Creutzfeldt-Jakobdisease (vCJD) is likely caused by the consumption of products contaminated with the agent that causes BSE. FDA hasbecome aware of new literature which indicates that portions of the small intestine besides the distal ileum may harbor theprions causative of BSE. FDA believes that it should obtain comments from the public on the significance of these new reportsand is reopening the comment period for this regulation.

Priority: Other Significant Agenda Stage of Rulemaking: Long-term ActionMajor: No Unfunded Mandates: NoCFR 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 371Legal Deadline: None

Timetable: Action Date FR Cite Final Action 00/00/0000 Interim Final Rule Effective 07/14/2004 Interim Final Rule 07/14/2004 69 FR 42256 Interim Final Rule Comment Period End 10/12/2004 Interim Final Rule (Amendments) 09/07/2005 70 FR 53063 Interim Final Rule (Amendments) Effective 10/07/2005 Interim Final Rule (Amendments) Comment Period End 11/07/2005 Interim Final Rule (Amendments) 04/17/2008 73 FR 20785 Interim Final Rule (Amendments) Effective 07/16/2008 Interim Final Rule (Amendments) Comment Period End 07/16/2008

Regulatory Flexibility Analysis Required: No Government Levels Affected: NoFederalism: NoEnergy Affected: NoInternational Impacts: This regulatory action will be likely to have international trade and investment effects, or otherwise be ofinternational interest.Agency Contact: Amber McCoig Consumer Safety OfficerDepartment of Health and Human ServicesFood and Drug AdministrationCenter for Food Safety and Applied Nutrition (HFS-316) 5100 Paint Branch ParkwayCollege Park , MD 20740 Phone: 240 402-2131 FAX: 301 436-2644E-Mail: [email protected]



Title: Pet Food Labeling RequirementsAbstract: The President signed into law the Food and Drug Administration Amendments Act of 2007 (FDAAA) on September27, 2007 (Pub. L. 110-85). Title X of the FDAAA includes several provisions pertaining to food safety, including the safety of petfood. Section 1002(a)(3) of the new law directs FDA to issue new regulations to establish updated standards for the labeling ofpet food that include nutritional and ingredient information. This same provision of the law also directs that, in developing these

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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 ActionMajor: No Unfunded Mandates: NoCFR 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 Source Description Date Other Statutory 09/27/2009


Regulatory Flexibility Analysis Required: Business Government Levels Affected: StateFederalism: YesEnergy Affected: NoInternational Impacts: This regulatory action will be likely to have international trade and investment effects, or otherwise be ofinternational interest.Agency Contact: William Burkholder Veterinary Medical OfficerDepartment of Health and Human ServicesFood and Drug AdministrationCenter for Veterinary Medicine Room 2642 (MPN-4, HFV-228) 7519 Standish PlaceRockville , MD 20855 Phone: 240 453-6865 E-Mail: [email protected]



Title: Animal Drugs, Feeds, and Related Products; Regulation of Carcinogenic Compounds in Food-Producing AnimalsAbstract: 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, oranimal drug can be deemed safe if it is found to induce cancer in man or animals. An exception can be made for animal drugsand additives used in food producing animals if it can be found that: (1) An animal feed additive, color additive, or animal drugwill not adversely affect the animal, and (2) no residue of the animal feed additive, color additive, or animal drug will be found inany edible portion of that animal when residues are measured according to an approved regulatory method. FDA regulationsimpose requirements for the sensitivity of the approved regulatory method for testing residues of carcinogenic compounds inedible animal tissues. The regulatory method must be sensitive enough to detect levels of carcinogenic compound thatcorresponds to the level of the compound that may be consumed daily by the human consumer with no significant increase inthe risk of cancer. The sensitivity is calculated by determining the concentration of residue of carcinogenic concern in the totaldiet that can safely be consumed by humans over a lifetime. This concentration is termed the So. The So is currently defined byregulation primarily as the concentration of the carcinogenic compound that corresponds to a maximum lifetime risk to testanimals of 1 in 1 million, and secondarily as corresponding to the concentration of residue of carcinogenic concern in the totalhuman diet that represents no significant increase in the risk of cancer to people. FDA believes that a careful reading of theDecember 31, 1987, final rule (52 FR 49586) suggests that an emphasis on no significant increase in the risk of cancer to thehuman 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 concentrationof residue of carcinogenic concern in the total human diet that represents no significant increase in the risk of cancer to thehuman consumer and secondarily corresponds to the concentration of test compound in the total diet of test animals thatcorresponds to a maximum lifetime risk of cancer in the test animals of 1 in 1 million. These changes reflect advances inscientific technology. Other clarifying and conforming changes are also being proposed.

Priority: Substantive, Nonsignificant Agenda Stage of Rulemaking: Long-term ActionMajor: No Unfunded Mandates: NoCFR 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 Date FR Cite Final Action 00/00/0000 NPRM 12/20/2010 75 FR 79320 NPRM Comment Period End 03/07/2011

Regulatory Flexibility Analysis Required: No Government Levels Affected: NoFederalism: NoAgency Contact: Kevin Greenlees Senior Science AdvisorDepartment of Health and Human ServicesFood and Drug AdministrationCenter for Veterinary Medicine Room 238B (MPN-1, HFV-100) 7520 Standish PlaceRockville , MD 20855 Phone: 240 276-8214 FAX: 240 276-8118E-Mail: [email protected]



Title: Food Labeling; Dietary Guidance StatementsAbstract: This proposed rule would define dietary guidance statements as statements in food labeling about the usefulness of afoods, or a category of foods, in maintaining healthy dietary practices. Dietary guidance statements focus on general dietarypatterns, practices, and recommendations that promote health. They may highlight the presence or amount of a food orcategory of foods in relation to a general health benefit or healthful diet or recommend the substitution of a food or foodcategory that is consistent with current dietary recommendations for a food or food category that is less beneficial to health. Theproposed rule would also establish requirements for making dietary guidance statements in food labeling. In addition, theproposed 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 ActionMajor: No Unfunded Mandates: UndeterminedCFR 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 371Legal Deadline: None


Regulatory Flexibility Analysis Required: Undetermined Government Levels Affected: UndeterminedFederalism: NoAgency Contact: Blakeley Fitzpatrick Interdisciplinary ScientistDepartment of Health and Human ServicesFood and Drug AdministrationCenter for Food Safety and Applied Nutrition (HFS-830) HFS-830 5100 Paint Branch ParkwayCollege Park , MD 20740 Phone: 240 402-1450 E-Mail: [email protected]

Department of Health and Human Services (HHS)

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Food and Drug Administration ( FDA ) RIN: 0910-AG60


Title: Further Amendments to General Regulations of the Food and Drug Administration to Incorporate Tobacco ProductsAbstract: 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 TobaccoControl 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 ActionMajor: No Unfunded Mandates: NoCFR 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 USC387c; 21 USC 387f; 21 USC 387k; 15 USC 1333; 15 USC 4402Legal Deadline: None


Regulatory Flexibility Analysis Required: Business Government Levels Affected: NoFederalism: NoAgency Contact: Gerie Voss Regulatory CounselDepartment of Health and Human ServicesFood and Drug Administration9200 Corporate BoulevardRockville , MD 20850 Phone: 877 287-1373 FAX: 240 276-4193E-Mail: [email protected]



Title: Food Labeling: Hard Candies and Breath MintsAbstract: The Food and Drug Administration is proposing to amend certain provisions of its serving size regulations to changethe label serving size for breath mints to one unit. This action is in response to an advanced notice of proposed rulemakingpublished in 2005, in which FDA requested comment on whether to amend certain provisions of its nutrition labeling regulationsconcerning serving size and a 1997 proposed rule entitled Food Labeling: Hard Candies and Breath Mints (62 FR 67775).

Priority: Substantive, Nonsignificant Agenda Stage of Rulemaking: Long-term ActionMajor: No Unfunded Mandates: UndeterminedCFR 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 371Legal Deadline: None

Timetable: Action Date FR Cite NPRM 12/30/1997 62 FR 67775 NPRM Comment Period End 03/16/1998 ANPRM 04/05/2005 70 FR 17010 ANPRM Comment Period End 06/20/2005 NPRM 12/00/2012

Regulatory Flexibility Analysis Required: Business Government Levels Affected: Federal; State

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Federalism: YesEnergy Affected: NoInternational Impacts: This regulatory action will be likely to have international trade and investment effects, or otherwise be ofinternational interest.Agency Contact: Mark Kantor NutritionistDepartment of Health and Human ServicesFood and Drug Administration5100 Paint Branch Parkway HFS-830College Park , MD 20740 Phone: 240 402-1450 FAX: 301 436-1191E-Mail: [email protected]



Title: Food Labeling; Serving Sizes; Reference Amounts for CandiesAbstract: The Food and Drug Administration is proposing to amend certain provisions of its serving size regulations to provideupdated Reference Amounts Customarily Consumed for candies. This action is in response to an advance notice of proposedrulemaking published in 2005, in which FDA requested comment on whether to amend certain provisions of its nutrition labelingregulations concerning serving size and a 1998 proposed rule entitled "Food Labeling: Reference Amounts for Candies" (63 FR1078).

Priority: Substantive, Nonsignificant Agenda Stage of Rulemaking: Long-term ActionMajor: No Unfunded Mandates: UndeterminedCFR 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 371Legal Deadline: None

Timetable: Action Date FR Cite NPRM 01/08/1998 63 FR 1078 NPRM Comment Period End 02/09/1998 ANPRM 04/05/2005 70 FR 17010 ANPRM Comment Period End 06/20/2005 NPRM 12/00/2012

Regulatory Flexibility Analysis Required: Business Government Levels Affected: Federal; StateFederalism: YesEnergy Affected: NoAgency Contact: Mark Kantor NutritionistDepartment of Health and Human ServicesFood and Drug Administration5100 Paint Branch Parkway HFS-830College Park , MD 20740 Phone: 240 402-1450 FAX: 301 436-1191E-Mail: [email protected]



Title: Tobacco Product Standard70





Abstract: Section 907 of the Federal Food, Drug, and Cosmetic Act, as amended by the Family Smoking Prevention andTobacco Control Act, authorizes FDA to issue tobacco product standards that the agency finds are appropriate for the protectionof the public health. FDA intends to develop one or more tobacco product standards to reduce the harms and/or addictivenessof tobacco products or that is otherwise appropriate for the protection of the public health.

Priority: Other Significant Agenda Stage of Rulemaking: Long-term ActionMajor: Undetermined Unfunded Mandates: UndeterminedCFR 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 907Legal Deadline: None


Regulatory Flexibility Analysis Required: Undetermined Government Levels Affected: UndeterminedSmall Entities Affected: Business Federalism: UndeterminedEnergy Affected: NoAgency Contact: Annette L. Marthaler Regulatory CounselDepartment of Health and Human ServicesFood and Drug Administration9200 Corporate Boulevard, Room 340KRockville , MD 20850 Phone: 877 287-1373 FAX: 240 276-3904E-Mail: [email protected]



Title: Blood Initiative--Requirements for Human Blood and Blood Components Intended for Transfusion or for FurtherManufacturing UseAbstract: The Food and Drug Administration (FDA) is amending the biologics regulations, particularly those related to blooddonor 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. Thisaction is based on FDA's comprehensive review of the biologics regulations. It is also responsive to reports by the U.S. Houseof Representatives Committee on Government Reform and Oversight Subcommittee on House Resources andIntergovernmental Relations, the Government Accountability Office (previously, the General Accounting Office), and the Instituteof Medicine, and to public comments. These actions are intended to help ensure the continued safety of the Nation's bloodsupply.

Priority: Other Significant Agenda Stage of Rulemaking: Long-term ActionMajor: Undetermined Unfunded Mandates: NoCFR 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 aspecific 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 USC360h 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; 42USC 262 and 263; 42 USC 263a; 42 USC 264; 42 USC 271Legal Deadline: None

Timetable: Action Date FR Cite NPRM 11/08/2007 72 FR 63416 NPRM Comment Period Extended 01/11/2008 73 FR 1983 NPRM Comment Period End 02/06/2008 NPRM Comment Period Extended End 08/04/2008 Final Action 12/00/2012

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Regulatory Flexibility Analysis Required: No Government Levels Affected: NoSmall Entities Affected: Business Federalism: NoEnergy Affected: NoAgency Contact: Valerie A. Butler Team LeaderDepartment of Health and Human ServicesFood and Drug AdministrationCenter for Biologics Evaluation and Research Suite 200N (HFM-17) 1401 Rockville PikeRockville , MD 20852 Phone: 301 827-6210 FAX: 301 827-3093E-Mail: [email protected]

Department of Health and Human Services (HHS) Food and Drug Administration ( FDA ) RIN: 0910-AC25


Title: Medical Devices; Exception From General Requirements for Informed ConsentAbstract: This rule affirmed the interim final rule's exception from the general requirement for informed consent in certaincircumstances involving the use of investigational in vitro diagnostic devices to identify chemical, biological, radiological, ornuclear agents in a potential terrorist event or other public health emergency. Informed consent will be required unless theclinical investigator determines in writing that: 1) There exists a life-threatening situation involving the human subject of suchtesting 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 uninvolvedin the testing must agree in writing with this three-part determination before the product is used unless immediate use of thedevice 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 thedocumentation to the Institutional Review Board (IRB).

Priority: Other Significant Agenda Stage of Rulemaking: Completed ActionMajor: No Unfunded Mandates: NoCFR 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; 21USC 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; 42USC 241; 42 USC 262; 42 USC 263b to 263nLegal Deadline: None

Timetable: Action Date FR Cite Interim Final Rule 06/07/2006 71 FR 32827 Interim Final Rule Comment Period End 08/07/2006 Final Action 06/24/2011 76 FR 36989

Regulatory Flexibility Analysis Required: No Government Levels Affected: StateSmall Entities Affected: No Federalism: NoAgency Contact: Claudia M. Gaffey Medical OfficerDepartment of Health and Human ServicesFood and Drug AdministrationCenter for Devices and Radiological Health WO66, Room 5516 10903 New Hampshire AvenueSilver Spring , MD 20993 Phone: 301 796-6196 FAX: 301 847-8144E-Mail: [email protected]


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Title: Over-the-Counter (OTC) Drug Review--Cough/Cold (Bronchodilator) ProductsAbstract: The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safeand effective and not misbranded. After a final monograph (i.e., final rule) is issued, only OTC drugs meeting the conditions ofthe monograph, or having an approved new drug application, may be legally marketed. This action addresses labeling for singleingredient bronchodilator products.

Priority: Substantive, Nonsignificant Agenda Stage of Rulemaking: Completed ActionMajor: No Unfunded Mandates: NoCFR Citation: 21 CFR 201; 21 CFR 310; 21 CFR 330 to 358 (To search for a specific CFR, visit the Code of FederalRegulations ) Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 360; 21 USC 371Legal Deadline: None

Timetable: Action Date FR Cite NPRM (Amendment--Ephedrine Single Ingredient) 07/13/2005 70 FR 40237 NPRM Comment Period End 11/10/2005 Final Action (Technical Amendment) 11/30/2007 72 FR 67639 Final Action (Amendment--Single Ingredient Labeling) 07/26/2011 76 FR 44475

Regulatory Flexibility Analysis Required: Business Government Levels Affected: Local; StateFederalism: YesRelated RINs: Split From 0910-AA01Agency Contact: Mary Chung Department of Health and Human ServicesFood and Drug AdministrationCenter for Drug Evaluation and Research WO 22, Room 5488 10903 New Hampshire AvenueSilver Spring , MD 20993 Phone: 301 796-0260 FAX: 301 796-9899E-Mail: [email protected]



Title: Over-the-Counter (OTC) Drug Review--Poison Treatment Drug ProductsAbstract: The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safeand effective and not misbranded. After a final monograph (i.e., final rule) is issued, only OTC drugs meeting the conditions ofthe monograph, or having an approved new drug application, may be legally marketed. This action addresses the ingredientipecac syrup.

Priority: Substantive, Nonsignificant Agenda Stage of Rulemaking: Completed ActionMajor: No Unfunded Mandates: NoCFR Citation: 21 CFR 201; 21 CFR 310; 21 CFR 330 to 358 (To search for a specific CFR, visit the Code of FederalRegulations ) Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 360; 21 USC 371Legal Deadline: None

Timetable: Action Date FR Cite Withdrawn 09/08/2011

Regulatory Flexibility Analysis Required: Business Government Levels Affected: Local; StateFederalism: YesAgency Contact: David Eng Department of Health and Human ServicesFood and Drug Administration

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Center for Drug Evaluation and Research WO 22, Room 5487 10903 New Hampshire AvenueSilver Spring , MD 20993 Phone: 301 796-2773 FAX: 301 796-9899E-Mail: [email protected]



Title: Animal Food Labeling; Declaration of Certifiable Color AdditivesAbstract: The Food and Drug Administration (FDA) is amending its regulations regarding the declaration of certified coloradditives on the labels of animal food including animal feeds and pet foods. FDA is proposing this amendment in response tothe Nutrition Labeling and Education Act of 1990 (PL 101-535), which amended section 403 of the Federal Food, Drug, andCosmetic Act (21 USC 343) by requiring, among other things, the listing on food labels of the common or usual names of allcolor additives required to be certified by FDA. An additional purpose of this amendment is to make these regulations consistentwith the regulations regarding the declaration of certified color additives on the labels of human food. The final rule alsosuggests appropriate terminology for the declaration of certification-exempt color additives on the labels of animal food.

Priority: Substantive, Nonsignificant Agenda Stage of Rulemaking: Completed ActionMajor: No Unfunded Mandates: NoCFR 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


Regulatory Flexibility Analysis Required: No Government Levels Affected: NoFederalism: NoInternational Impacts: This regulatory action will be likely to have international trade and investment effects, or otherwise be ofinternational interest.Agency Contact: John P. Machado Veterinary Medical OfficerDepartment of Health and Human ServicesFood and Drug AdministrationCenter for Veterinary Medicine Room 2640 (MPN-4, HFV-228) 7519 Standish PlaceRockville , MD 20855 Phone: 240 453-6854 FAX: 240 453-6882E-Mail: [email protected]



Title: Tobacco Product Substantial Equivalence ExemptionsAbstract: This rule implements the substantial equivalence exemption provision of the Family Smoking Prevention andTobacco Control Act. The Secretary may exempt from the requirements relating to demonstration that a tobacco product issubstantially equivalent, tobacco products that are modified by adding or deleting a tobacco additive or increasing or decreasingthe quantity of an existing tobacco additive, if the Secretary determines the modification would be a minor modification of atobacco product that can be sold under the law, a report is not necessary to ensure that permitting the tobacco product to bemarketed 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 ActionMajor: No Unfunded Mandates: NoCFR 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 387jLegal Deadline:



Regulatory Flexibility Analysis Required: No Government Levels Affected: NoFederalism: NoAgency Contact: Annette L. Marthaler Regulatory CounselDepartment of Health and Human ServicesFood and Drug Administration9200 Corporate Boulevard, Room 340KRockville , MD 20850 Phone: 877 287-1373 FAX: 240 276-3904E-Mail: [email protected]



Title: Cigarette Warning Label StatementsAbstract: Section 4 of the FCLAA, as amended by section 201 of the Tobacco Control Act, requires FDA to issue regulationsthat require color graphics depicting the negative health consequences of smoking to accompany required warning statementson cigarette packages and advertisements. FDA also may adjust the type size, text and format of the required label statementson product packaging and advertising if FDA determines that it is appropriate so that both the graphics and the accompanyinglabel statements are clear, conspicuous, legible and appear within the specified area.

Priority: Economically Significant Agenda Stage of Rulemaking: Completed ActionMajor: Yes Unfunded Mandates: Private SectorCFR 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 201Legal Deadline: Section 4 of the Federal Cigarette Labeling and Advertising Act (FCLAA), as amended by section 201 of theFamily Smoking Prevention and Tobacco Control Act (the Tobacco Control Act), requires FDA to issue regulations no later than24 months after the date of enactment of the Tobacco Control Act that require color graphics depicting the negative healthconsequences of smoking to appear on cigarette packages and advertisements.



Regulatory Flexibility Analysis Required: Business Government Levels Affected: NoFederalism: NoEnergy Affected: NoInternational 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 CounselDepartment of Health and Human ServicesFood and Drug Administration9200 Corporate BoulevardRockville , MD 20850 Phone: 877 287-1373 FAX: 240 276-4193E-Mail: [email protected]



Title: Effective Date of Requirement for Premarket Approval for Three Class III Preamendments DevicesAbstract: The purpose of this rule required the submission of a premarket approval application or notice of completion of aproduct development protocol for three class III preamendments devices. This regulation will provide FDA with more oversightconcerning the three class III device types that currently can be marketed via less stringent premarket notification procedures. Iffinalized, this regulation will require premarket approval for the three class III device types within 90 days of the issuance of afinal 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 findingson the three device types and provides an opportunity to request a change in classification of the devices based on newinformation.

Priority: Substantive, Nonsignificant Agenda Stage of Rulemaking: Completed ActionMajor: No Unfunded Mandates: NoCFR 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


Regulatory Flexibility Analysis Required: No Government Levels Affected: NoFederalism: NoEnergy Affected: NoAgency Contact: Nancy Pirt Regulatory CounselDepartment of Health and Human ServicesFood and Drug AdministrationCenter for Devices and Radiological Health WO 66, Room 4438 10903 New Hampshire AvenueSilver Spring , MD 20993 Phone: 301 796-6248 FAX: 301 847-8145E-Mail: [email protected]

Department of Health and Human Services (HHS) Indian Health Service ( IHS ) RIN: 0917-AA08


Title: Standards for the Planning, Design, Construction and Operation of Health Care and Sanitation FacilitiesAbstract: Section 311(c)(1) of the Indian Health Care Improvement Act, Public Law No. 94-437 (1976), as amended by thePatient 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 ofhealth care and sanitation facilities serving Indians under the Indian Health Care Improvement Act. Additionally, theseregulations would stipulate which departmental regulations would be applicable to these activities.

Priority: Other Significant Agenda Stage of Rulemaking: Proposed RuleMajor: Undetermined Unfunded Mandates: UndeterminedCFR 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 10221Legal Deadline: None


Regulatory Flexibility Analysis Required: Undetermined Government Levels Affected: UndeterminedFederalism: NoAgency Contact: Ronald C. Ferguson Director, Division of Sanitation Facilities ConstructionDepartment of Health and Human ServicesIndian Health Service801 Thompson Avenue, TMP 610Rockville , MD 20852 Phone: 301 443-1046 E-Mail: [email protected]



Title: Confidentiality of Medical Quality Assurance Records; Qualified Immunity for ParticipantsAbstract: Section 805(j)) of the Indian Health Care Improvement Act, Public Law No. 94-437 (1976), as amended by thePatient Protection and Affordable Care Act, Public Law No. 111-148, section 10221 (2010) requires the Secretary of theDepartment of Health and Human Services, acting through the Indian Health Service (IHS), to promulgate regulations toimplement section 805. Section 805 makes confidential and privileged the medical quality assurance records of Indian healthprograms and urban Indian organizations, with very limited exceptions. It also prohibits the testimony of individuals that reviewor create medical quality assurance records, with very limited exceptions. Although section 805 is immediately executable, theSecretary is required to issue regulations which could substantively affect the implementation of this provision.

Priority: Other Significant Agenda Stage of Rulemaking: Proposed RuleMajor: No Unfunded Mandates: NoCFR 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 10221Legal Deadline: None


Regulatory Flexibility Analysis Required: No Government Levels Affected: UndeterminedFederalism: NoEnergy Affected: NoAgency Contact: Paul Fowler IHS Risk Management OfficerDepartment of Health and Human ServicesIndian Health Service801 Thompson Avenue Suite 331Rockville , MD 20852 Phone: 301 443-6372 FAX: 301 594-6213

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E-Mail: [email protected]



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 bythe Patient Protection and Affordable Care Act, Public Law No. 111-148, section 10221 (2010) requires the Secretary of theDepartment of Health and Human Services, acting through the Indian Health Service (IHS), to promulgate regulations toimplement section 202. Section 202 of the IHCIA amends the IHS Catastrophic Health Emergency Fund (CHEF) to revise thethreshold cost for reimbursement of the cost of treatment using contract health services funds to an IHS or Tribally managedfacility. The law also describes an annual increase in the threshold that is based on the increase in the medical care expenditurecategory 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 RuleMajor: Undetermined Unfunded Mandates: NoCFR 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 10221Legal Deadline: None


Regulatory Flexibility Analysis Required: Undetermined Government Levels Affected: UndeterminedFederalism: NoEnergy Affected: NoAgency Contact: Carl Harper Director, Office of Resource Access and PartnershipsDepartment of Health and Human ServicesIndian Health Service801 Thompson Avenue TMP Suite 360Rockville , MD 20852 Phone: 301 443-1016 E-Mail: [email protected]

Department of Health and Human Services (HHS) Centers for Disease Control and Prevention ( CDC ) RIN: 0920-AA21


Title: Amendments to Specifications for Medical Examinations of Underground Coal MinersAbstract: NIOSH plans to modify sections of 42 CFR part 37 to allow for the use of digital radiography in medical screening ofcoal miners for coal workers' pneumoconiosis. Current provisions of these regulations require the use of film radiography whichis being phased out of use at medical facilities in the United States.

Priority: Other Significant Agenda Stage of Rulemaking: Proposed RuleMajor: No Unfunded Mandates: NoCFR Citation: 42 CFR 37 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: 30 USC 843Legal Deadline: None


78






Regulatory Flexibility Analysis Required: No Government Levels Affected: FederalFederalism: NoAgency Contact: David Weissman Director, Division of Respiratory Disease StudiesDepartment of Health and Human ServicesCenters for Disease Control and Prevention1095 Willowdale Road MS G900Morgantown , WV 26505 Phone: 304 285-5749 E-Mail: [email protected]



Title: Inward Leakage Requirements for RespiratorsAbstract: NIOSH plans to re-issue this NPRM in response to public comment. The proposed rule will improve certificationrequirements for half-mask air-purifying particulate respirators and establish performance requirements for an alternate class ofhalf-mask air-purifying respirators to prevent inward leakage of contaminants through the face seal and evaluate non-filtercomponents. The rule would supplement existing requirements for testing the performance of the filter and thus providemanufacturers greater flexibility in their applications.

Priority: Other Significant Agenda Stage of Rulemaking: Proposed RuleMajor: No Unfunded Mandates: NoCFR 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 844Legal Deadline: None

Timetable: Action Date FR Cite NPRM 10/30/2009 74 FR 66935 NPRM Comment Period End 12/29/2009 NPRM Comment Period Reopened 04/20/2010 75 FR 20546 NPRM Public Meeting 07/29/2010 75 FR 29699 NPRM Comment Period End 09/30/2010 NPRM 05/00/2012

Regulatory Flexibility Analysis Required: No Government Levels Affected: NoSmall Entities Affected: No Federalism: NoEnergy Affected: NoAgency Contact: William E. Newcomb Physical ScientistDepartment of Health and Human ServicesCenters for Disease Control and PreventionPO Box 18070 626 Cochrans Mill RoadPittsburgh , PA 15236 Phone: 412 386-5200 E-Mail: [email protected]



Title: Public Health Security and Bioterrorism Preparedness and Response Act of 2002; Biennial Review and Republication ofthe Select Agent and Toxin ListAbstract: The Bioterrorism Preparedness Act requires that the HHS Secretary review and republish the list of select agentsand toxins on at least a biennial basis. To assist with the biennial review, HHS reviewed recommendations provided by subject

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matter experts and the Intragovernmental Select Agents and Toxins Advisory Committee. In addition, on July 2, 2010, thePresident 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 establishingphysical security standards for identified Tier 1 select agents and toxins. This final rule implements the Executive Order andupdates the list of select agents and toxins.

Priority: Other Significant Agenda Stage of Rulemaking: Proposed RuleMajor: No Unfunded Mandates: NoCFR 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 Date FR Cite NPRM 10/03/2011 76 FR 61206 NPRM Comment Period End 12/02/2011 NPRM Comment Period Reopened 12/16/2011 76 FR 78215 NPRM Comment Period Reopened End 01/17/2012 Final Action 10/00/2012

Regulatory Flexibility Analysis Required: No Government Levels Affected: NoSmall Entities Affected: No Federalism: NoEnergy Affected: NoAgency Contact: Robbin Weyant Director, Division of Select Agents and ToxinsDepartment of Health and Human ServicesCenters for Disease Control and PreventionMS A-46 Clifton Road NE.Atlanta , GA 30333 Phone: 404 718-2000 E-Mail: [email protected]



Title: Control of Communicable Diseases: Foreign and Possessions; Proposed Revision of CDC Etiological Agents ImportationRegulationsAbstract: By statute, CDC implements regulations found at 42 CFR 71.54 restricting the importation and transportation ofetiologic agents. Importers are required to complete an application for permit. Under its current regulatory framework, policiesand 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 permitapplication. Rule-making is needed with the aim of improving CDC's ability to prevent importation of communicable diseases intothe United States. CDC is considering whether to adopt a program similar to the U.S. Department of Agriculture/Animal andPlant Health Inspection Service Program such as conducting inspections on importer facilities prior to issuance of a permit foretiologic agents such as Mycobacterium tuberculosis and Hantavirus, providing an appeal process for denied applications.

Priority: Other Significant Agenda Stage of Rulemaking: Proposed RuleMajor: No Unfunded Mandates: NoCFR 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


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Regulatory Flexibility Analysis Required: No Government Levels Affected: NoSmall Entities Affected: No Federalism: NoEnergy Affected: NoAgency Contact: Robbin Weyant Director, Division of Select Agents and ToxinsDepartment of Health and Human ServicesCenters for Disease Control and PreventionMS A-46 Clifton Road NE.Atlanta , GA 30333 Phone: 404 718-2000 E-Mail: [email protected]



Title: Open-Circuit Self-Contained Breathing Apparatus End-of-Service-Time Indicator Performance RequirementsAbstract: The end-of-service-time indicators are devices built into respirators to alert the users that the oxygen provided to theuser is close to depletion. This rule responds to a petition to allow the indicators to be set to better match the different workerprotection needs to different work operations.

Priority: Other Significant Agenda Stage of Rulemaking: Proposed RuleMajor: No Unfunded Mandates: NoCFR 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 957Legal Deadline: None


Regulatory Flexibility Analysis Required: No Government Levels Affected: NoFederalism: NoEnergy Affected: NoAgency Contact: Jon Szalajda Chief, Policy and Standards BranchDepartment of Health and Human ServicesCenters for Disease Control and Prevention626 Cochrans Mill RoadPittsburgh , PA 15236 Phone: 412 386-5200 E-Mail: [email protected]



Title: Amendments to Respirator Certification FeesAbstract: NIOSH approves respirators used in a variety of industrial settings; regulations governing approval are codified in 42CFR part 84. The fees charged to respirator manufacturers for approval of their products have not changed since 1972; thecurrent approval fees cover less than 10 percent of the costs of generating certificates. Updating these fees will allow NIOSH'srespirator certification program to recover the costs associated with the approval process.

Priority: Other Significant Agenda Stage of Rulemaking: Proposed RuleMajor: No Unfunded Mandates: NoCFR 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 957Legal Deadline: None


Regulatory Flexibility Analysis Required: No Government Levels Affected: NoSmall Entities Affected: No Federalism: NoEnergy Affected: NoAgency Contact: David Book Physical ScientistDepartment of Health and Human ServicesCenters for Disease Control and Prevention626 Cochrans Mill RdPittsburgh , PA 15236 Phone: 412 386-6691 E-Mail: [email protected]



Title: Establishment of Minimum Standards for Birth CertificatesAbstract: Section 7211 of the Intelligence Reform and Terrorism Prevention Act (IRTPA) mandates that HHS establish, byregulation, 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 RuleMajor: No Unfunded Mandates: State, Local, Or Tribal GovernmentsCFR Citation: Not Yet Determined (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: 42 USC 264Legal Deadline:



Regulatory Flexibility Analysis Required: GovernmentalJurisdictions Government Levels Affected: Federal; Local; State

Federalism: YesEnergy Affected: NoAgency Contact: Charles Rothwell Director, Division of Vital StatisticsDepartment of Health and Human ServicesCenters for Disease Control and Prevention3311 Toledo Road Room 7311, MHyattsville , MD 20782 Phone: 301 458-4555



Title: Establishment of User Fees for Filovirus Testing of Nonhuman Primate Liver Samples82





Abstract: HHS/CDC requires Filovirus testing of all nonhuman primates that die for any reason other than trauma during the 31day 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 ofTransportation and International Air Transport Association regulations. Testing will be conducted by CDC laboratories. Thisregulation will establish user fees that will be effective immediately.

Priority: Other Significant Agenda Stage of Rulemaking: Proposed RuleMajor: No Unfunded Mandates: NoCFR Citation: 42 CFR 71.53 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: 42 USC 264Legal Deadline: None

Timetable: Action Date FR Cite NPRM/Direct Final Rule 02/00/2012

Regulatory Flexibility Analysis Required: No Government Levels Affected: NoFederalism: NoEnergy Affected: NoAgency Contact: Ashley Marrone Public Health AnalystDepartment of Health and Human ServicesCenters for Disease Control and PreventionMS-E03 1600 Clifton Road NE.Atlanta , GA 30329 Phone: 404 498-1600 E-Mail: [email protected]



Title: Approval Tests and Standards for Closed-Circuit Escape RespiratorsAbstract: This rule updates performance testing and other specifications for the certification of closed-circuit self-containedescape breathing apparatus. These respiratory protective devices are used in emergencies for the protection of miners andworkers in other industries.

Priority: Other Significant Agenda Stage of Rulemaking: Final RuleMajor: No Unfunded Mandates: NoCFR 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 844Legal Deadline: None

Timetable: Action Date FR Cite NPRM 12/10/2008 73 FR 75027 NPRM Comment Period End 02/09/2009 NPRM Comment Period Reopened 03/04/2009 74 FR 9380 NPRM Comment Period End 04/10/2009 NPRM Comment Period Reopened 05/21/2009 74 FR 23814 NPRM Comment Period End 06/19/2009 Final Action 02/00/2012

Regulatory Flexibility Analysis Required: No Government Levels Affected: NoSmall Entities Affected: No Federalism: NoEnergy Affected: NoAgency Contact: Tim Rehak General Engineer

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Department of Health and Human ServicesCenters for Disease Control and Prevention626 Cochran Mill RoadPittsburgh , PA 15236 Phone: 412 386-5200 FAX: 412 386-4089E-Mail: [email protected]



Title: Control of Communicable Diseases: Foreign and Possessions Regulations; Nonhuman PrimateAbstract: In this final rule, CDC will amend its regulations related to the importation of live nonhuman primates (NHPs) byextending existing requirements for the importation of cynomolgus, African green, and rhesus monkeys to all NHPs. CDC willalso reduce the frequency at which importers of the three species are required to renew their registrations, (from every 180 daysto every two years) and incorporate existing guidelines into regulations. CDC will add new provisions to address NHPs importedas 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 quarantinestation is located.

Priority: Substantive, Nonsignificant Agenda Stage of Rulemaking: Final RuleMajor: No Unfunded Mandates: NoCFR Citation: 42 CFR 71.53 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: 42 USC 264Legal Deadline: None

Timetable: Action Date FR Cite NPRM 01/05/2011 76 FR 678 NPRM Comment Period End 03/07/2011 NPRM Comment Period Extended 03/10/2011 76 FR 13120 NPRM Comment Period Extended End 04/25/2011 Final Action 07/00/2012

Regulatory Flexibility Analysis Required: No Government Levels Affected: NoFederalism: NoAgency Contact: Ashley Marrone Public Health AnalystDepartment of Health and Human ServicesCenters for Disease Control and PreventionMS-E03 1600 Clifton Road NE.Atlanta , GA 30329 Phone: 404 498-1600 E-Mail: [email protected]



Title: Guidelines for Determining the Probability of Causation Under the Energy Employees Occupational Illness CompensationProgram Act of 2000; Revision of Guidelines for Non-Radiogenic CancersAbstract: The Department of Health and Human Services (HHS) will treat chronic lymphocytic leukemia (CLL) as a radiogeniccancer under the Energy Employees Occupational Illness Compensation Program Act of 2000 (EEOICPA). CLL has beenconsidered to be caused by radiation and hence not potentially compensable under EEOICPA. HHS reverses its decision toexclude CLL from such treatment.

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Priority: Other Significant Agenda Stage of Rulemaking: Final RuleMajor: No Unfunded Mandates: NoCFR Citation: 42 CFR 81.30 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: 42 USC 7384n; EO 13179Legal Deadline: None

Timetable: Action Date FR Cite NPRM 03/21/2011 76 FR 15268 NPRM Comment Period Extended 06/23/2011 76 FR 36891 NPRM Comment Period End 06/20/2011 NPRM Comment Period Extended End 07/20/2011 Final Action 01/00/2012

Regulatory Flexibility Analysis Required: No Government Levels Affected: FederalFederalism: NoEnergy Affected: NoAgency Contact: Stuart Hinnefeld Director, Division of Compensation Analysis and SupportDepartment of Health and Human ServicesCenters for Disease Control and Prevention4676 Columbia Parkway, MS-C46Cincinnati , OH 45226 Phone: 513 533-6800 E-Mail: [email protected]



Title: World Trade Center Health Program Requirements for Enrollment, Appeals, Certification of Health Conditions, andReimbursementAbstract: These regulations implement portions of the WTC Health Program established within the Department of Health andHuman Services. The WTC Health Program, which will be administered in part by the Director of NIOSH at CDC, will providemedical 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 HealthProgram, obtain health monitoring and treatment for WTC-related health conditions, and appeal enrollment and treatmentdecisions. The final rule also establishes reimbursement rates for providers who provide initial health evaluations, treatment, andhealth monitoring.

Priority: Economically Significant Agenda Stage of Rulemaking: Final RuleMajor: Yes Unfunded Mandates: NoCFR Citation: 42 CFR 88 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: PL 111-347Legal Deadline:



Regulatory Flexibility Analysis Required: No Government Levels Affected: FederalSmall Entities Affected: No Federalism: NoEnergy Affected: No

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Agency Contact: Roy Fleming Senior Science Advisor, World Trade Center Health ProgramDepartment of Health and Human ServicesCenters for Disease Control and Prevention1600 Clifton Road NE MS-E74Atlanta , GA 30329 Phone: 866 426-3673 E-Mail: [email protected]



Title: World Trade Center Health Program Requirements for the Addition of New WTC-Related Health ConditionsAbstract: This rule establishes the processes by which the WTC Program Administrator may add a new condition to the list ofWTC-related health conditions through rulemaking; and includes a process for considering petitions by interested parties to adda new condition.

Priority: Other Significant Agenda Stage of Rulemaking: Final RuleMajor: No Unfunded Mandates: NoCFR Citation: 42 CFR 88 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: PL 111-347Legal Deadline: None


Regulatory Flexibility Analysis Required: No Government Levels Affected: FederalSmall Entities Affected: No Federalism: NoEnergy Affected: NoAgency Contact: Roy Fleming Senior Science Advisor, World Trade Center Health ProgramDepartment of Health and Human ServicesCenters for Disease Control and Prevention1600 Clifton Road NE MS-E74Atlanta , GA 30329 Phone: 866 426-3673 E-Mail: [email protected]



Title: Control of Communicable Diseases: ForeignAbstract: The final rule focuses primarily on requirements relating to the reporting of deaths and illnesses onboard aircraftsand ships traveling from foreign countries into the United States, and the collection of specific traveler contact information for thepurpose of CDC contacting travelers in the event of an exposure to a communicable disease.

Priority: Economically Significant Agenda Stage of Rulemaking: Long-term ActionMajor: Yes Unfunded Mandates: Private SectorCFR 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 271Legal Deadline:

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Regulatory Flexibility Analysis Required: Business;Governmental Jurisdictions Government Levels Affected: Federal; State

Federalism: NoEnergy Affected: NoAgency Contact: Ashley Marrone Public Health AnalystDepartment of Health and Human ServicesCenters for Disease Control and PreventionMS-E03 1600 Clifton Road NE.Atlanta , GA 30329 Phone: 404 498-1600 E-Mail: [email protected]



Title: Control of Communicable Diseases: InterstateAbstract: This rule focuses primarily on requirements relating to the reporting of deaths and illnesses onboard aircraftstraveling domestically, and the collection of specific traveler contact information for the purpose of CDC contacting travelers inthe event of an exposure to a communicable disease.

Priority: Economically Significant Agenda Stage of Rulemaking: Long-term ActionMajor: Yes Unfunded Mandates: Private SectorCFR 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 to268; 42 USC 270 to 272; 42 USC 2001Legal Deadline:



Regulatory Flexibility Analysis Required: Business;Governmental Jurisdictions Government Levels Affected: Federal; State

Federalism: NoEnergy Affected: NoAgency Contact: Ashley Marrone Public Health AnalystDepartment of Health and Human ServicesCenters for Disease Control and PreventionMS-E03 1600 Clifton Road NE.Atlanta , GA 30329 Phone: 404 498-1600 E-Mail: [email protected]

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Title: Amendments To Establish Wildland Firefighting Protection Performance Requirements for Approval of RespiratoryProtective DevicesAbstract: NIOSH has determined this rulemaking is not required to develop a class of respirator. The National Fire ProtectionAssociation (NFPA) has developed NFPA 1984: Standard on Respirators for Wildland Fire Fighting Operations, 2011 Edition, asa national consensus standard. NIOSH participated in the committee that developed the standard, and NIOSH can certify, undercurrent 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 ActionMajor: No Unfunded Mandates: NoCFR 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


Regulatory Flexibility Analysis Required: No Government Levels Affected: NoFederalism: NoEnergy Affected: NoAgency Contact: Tim Rehak General EngineerDepartment of Health and Human ServicesCenters for Disease Control and Prevention626 Cochran Mill RoadPittsburgh , PA 15236 Phone: 412 386-5200 FAX: 412 386-4089E-Mail: [email protected]

Department of Health and Human Services (HHS) National Institutes of Health ( NIH ) RIN: 0925-AA43


Title: National Institutes of Health Loan Repayment ProgramsAbstract: NIH proposes to issue a single set of regulations to govern all of its loan repayment (LRP) authorities. This action willinclude rescinding the current regulations at 42 CFR part 68a and at 42 CFR part 68c replaced by the new consolidated set ofLRP regulations. Establishing a single set of regulations to govern all eight of the current NIH loan repayment programs ratherthan issuing a separate set of regulations for each program will serve to streamline regulatory requirements for the programsand enhance program participants' understanding of and compliance with program requirements.

Priority: Substantive, Nonsignificant Agenda Stage of Rulemaking: Proposed RuleMajor: No Unfunded Mandates: NoCFR 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 288-6Legal Deadline: None








Small Entities Affected: No Federalism: NoEnergy Affected: NoAgency Contact: Jerry Moore NIH Regulations OfficerDepartment of Health and Human ServicesNational Institutes of Health6011 Executive BoulevardRockville , MD 20852 Phone: 301 496-4606 FAX: 301 402-0169E-Mail: [email protected]



Title: Undergraduate Scholarship Program Regarding Professions Needed by the National Institutes of HealthAbstract: Section 487D of the Public Health Service Act, as added by NIH Revitalization Act of 1993, creates a programoffering scholarships to individuals from disadvantaged backgrounds who are enrolled as full-time students at accreditedinstitutions pursuing academic programs appropriate for careers in professions needed by NIH. For each year of scholarshipsupport, the recipient agrees to provide service (employment) after graduation, at NIH, for 1 year. Additionally, the individualagrees to provide at least 10 consecutive weeks of service (employment) at NIH during which the individual is attending theeducational institution and receiving the NIH scholarship. The proposed new regulations will govern this program.

Priority: Substantive, Nonsignificant Agenda Stage of Rulemaking: Proposed RuleMajor: No Unfunded Mandates: NoCFR Citation: 42 CFR 68b (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: 42 USC 216; 42 USC 288-4Legal Deadline: None


Regulatory Flexibility Analysis Required: No Government Levels Affected: NoSmall Entities Affected: No Federalism: NoEnergy Affected: NoAgency Contact: Jerry Moore NIH Regulations OfficerDepartment of Health and Human ServicesNational Institutes of Health6011 Executive BoulevardRockville , MD 20852 Phone: 301 496-4606 FAX: 301 402-0169E-Mail: [email protected]



Title: Expanded Registration and Results Reporting at ClinicalTrials.govAbstract: The National Institutes of Health (NIH) proposes to issue new regulations that will prescribe procedures forregistering and reporting the results, including adverse events, of clinical trials in ClinicalTrials.gov, in accordance with section801 of the Food and Drug Administration Amendments Act of 2007, (FDAAA, PL. 110-85). As previously announced, the agencyintends to proceed with a single rulemaking to implement the expanded registry, results reporting, and adverse eventinformation reporting requirements of the statute. The rulemaking will also consider topics that the statute requires to be

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addressed in regulations intended [to provide more complete results information and to enhance patient access to andunderstanding of the results of clinical trials] [as codified in 42 U.S.C. 282(j)(3)(D)], including whether results information shouldbe 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 resultscan be included in the data bank without being misleading or promotional. These topics were the subject of discussion at thepublic meeting organized by NIH in April 2009, and of written public comments. The regulations will identify the trials that aresubject to the registration and results reporting requirements (including adverse event reporting); the specific information andformat of the information that must be submitted to ClinicalTrials.gov; deadlines for registering and reporting results; proceduresfor extending the deadlines or waiving the submission requirements; and procedures for agency review and public posting ofsubmitted information.

Priority: Other Significant Agenda Stage of Rulemaking: Proposed RuleMajor: No Unfunded Mandates: NoCFR 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:



Regulatory Flexibility Analysis Required: Undetermined Government Levels Affected: NoSmall Entities Affected: Business Federalism: NoEnergy Affected: NoAgency Contact: Jerry Moore NIH Regulations OfficerDepartment of Health and Human ServicesNational Institutes of Health6011 Executive BoulevardRockville , MD 20852 Phone: 301 496-4606 FAX: 301 402-0169E-Mail: [email protected]



Title: Privacy Act Regulation Concerning NIH Records Related to Research Misconduct ProceedingsAbstract: The Department of Health and Human Services (HHS), through the National Institutes of Health (NIH), isimplementing a new system of records, 09-25-0223, "NIH Records Related to Misconduct Proceedings, HHS/NIH." HHS wouldexempt this system of records from certain requirements of the Privacy Act, to protect records compiled in the course of NIHresearch-mission proceedings, and to protect the identity of confidential course in such proceedings. HHS is issuing direct finalrule for this action because the agency expects that there will be no significant adverse comment on this rule. HHS is alsopublishing a companion proposed rule under the agency's usual procedures for notice-and-comment rulemaking, to provide aprocedural framework to finalize the rule in the event the agency receives any significant comments and withdraws the directfinal rule. The companion proposed rule and direct final rule will be substantively identical.

Priority: Substantive, Nonsignificant Agenda Stage of Rulemaking: Final RuleMajor: No Unfunded Mandates: NoCFR Citation: 45 CFR 5b (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: 5 USC 301; 5 USC 552aLegal Deadline: None

Timetable: Action Date FR Cite Final Action 03/00/2012

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Regulatory Flexibility Analysis Required: No Government Levels Affected: UndeterminedSmall Entities Affected: No Federalism: NoEnergy Affected: NoAgency Contact: Jerry Moore NIH Regulations OfficerDepartment of Health and Human ServicesNational Institutes of Health6011 Executive BoulevardRockville , MD 20852 Phone: 301 496-4606 FAX: 301 402-0169E-Mail: [email protected]



Title: Endowment ProgramAbstract: 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 healthdisparities 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.

Priority: Other Significant Agenda Stage of Rulemaking: Completed ActionMajor: No Unfunded Mandates: NoCFR Citation: 42 CFR 52i (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: 42 USC 216; 42 USC 287c-31Legal Deadline: None





Title: NIH Training GrantsAbstract: NIH plans to amend the Agency's existing training grants regulations to: (1) Reflect their applicability to the trainingauthorities set forth in sections 464W and 485F of the Public Health Service Act; (2) reflect their applicability to trainingprograms 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 nonprofitinstitutions to provide training and instruction in the study and investigation of the prevention of disease, health promotion, and

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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 ActionMajor: No Unfunded Mandates: NoCFR 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-32Legal Deadline: None





Title: Amendment of Regulation of the Responsibility of Applicants for Promoting Objectivity in Research for Which PHSFunding Is Sought and Responsible Prospective ContractorsAbstract: The Department of Health and Human Services is issuing a final rule to amend the final rule to amend the PublicHealth Service(PHS) regulations on the Responsibility of Applicants for Promoting Objectivity in Research for Which PHSfunding is Sought and Responsible Prospective Contractors. Since the promulgation of the regulations in 1995, biomedical andbehavioral interactions among government research institutions and the private sector have become increasingly complex. Thiscomplexity, as well as a need to strengthen accountability, have led to the need for amendments to expand and addtransparency to investigator disclosure of significant financial interests, enhance regulatory compliance and effective institutionaloversight 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 ActionMajor: No Unfunded Mandates: NoCFR 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 3034Legal Deadline: None

Timetable: Action Date FR Cite ANPRM 05/08/2009 74 FR 21610 ANPRM Comment Period End 07/07/2009 NPRM 05/21/2010 75 FR 28688 NPRM Comment Period End 08/19/2010 75 FR 42362 Final Action 08/25/2011 76 FR 53256

Regulatory Flexibility Analysis Required: No Government Levels Affected: NoSmall Entities Affected: Business Federalism: NoEnergy Affected: NoAgency Contact: Jerry Moore NIH Regulations Officer

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Department of Health and Human ServicesNational Institutes of Health6011 Executive Boulevard Room 601, MSC 7669Rockville , MD 20852 Phone: 301 496-4607 FAX: 301 402-0169E-Mail: [email protected]



Title: National Institutes of Health Construction GrantsAbstract: The National Institutes of Health (NIH) proposes to review and/or amend the existing regulations at 42 CFR 52bgoverning 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 makethe building (or applicable part of the building) suitable for which it was constructed. The NIH proposes to revise and/or amendthe regulations to promote consistency with the Department of Health and Human Services (HHS) regulations at 45 CFR 74applicable to recovery and insurance coverage. Specifically, NIH proposes to replace language in section 52b.9(a)(1) with thelanguage in 45 CFR 74.32(c)(2), and replace the language in section 52b.10(n) with the language in 45 CFR 74.31. Thenarrative in section 52b.12(b) that refers to the National Cancer Institute having copies of certain resource documents would beupdated. Citations in section 52b.12(c) design and construction standards would be updated. Section 52b.14(c) would beamended 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 ActionMajor: Undetermined Unfunded Mandates: NoCFR 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 USC285m-3 and 285o-4; 42 USC 287a-2 and 287a-3; 42 USC 300cc-41Legal Deadline: None



Department of Health and Human Services (HHS) Substance Abuse and Mental Health Services Administration ( SAMHSA ) RIN: 0930-AA14


Title: Opioid Drugs in Maintenance or Detoxification Treatment of Opiate AddictionAbstract: This rule would amend the Federal opioid treatment program regulations. It would modify the dispensingrequirements for buprenorphine and buprenorphine combination products that are approved by the Food and DrugAdministration (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 RuleMajor: No Unfunded Mandates: NoCFR 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-11Legal Deadline: None


Regulatory Flexibility Analysis Required: No Government Levels Affected: NoSmall Entities Affected: No Federalism: NoEnergy Affected: NoAgency Contact: Nicholas Reuter Department of Health and Human ServicesSubstance Abuse and Mental Health Services AdministrationSuite 2-1063 One Choke Cherry RoadRockville , MD 20857 Phone: 240 276-2716 E-Mail: [email protected]



Title: Protection and Advocacy for Individuals With Mental IllnessAbstract: A final rule implementing the requirements of the Protection and Advocacy with Mental Illness Act was published onOctober 15, 1997 (Federal Register, Vol. 62, No. 193, page 53548). This proposed rule clarifies some of the requirements fromthat 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 thelegislation to provide representation to individuals living in a community setting, including their own home if the total allotmentunder the program for any fiscal year was $30 million or more. Prior to the passage of Public Law 106-310, the P&A systemscould 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 ActionMajor: Undetermined Unfunded Mandates: NoCFR 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 10801Legal Deadline: None


Regulatory Flexibility Analysis Required: No Government Levels Affected: NoSmall Entities Affected: No Federalism: UndeterminedEnergy Affected: NoAgency Contact: Joseph Denis Faha Director, DLEA, SAMHSADepartment of Health and Human ServicesSubstance Abuse and Mental Health Services Administration5600 Fishers LaneRockville , MD 20857 Phone: 301 443-7017 FAX: 301 443-1450

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Title: Community Mental Health Services and Substance Abuse Prevention and Treatment Block GrantsAbstract: 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 thecriteria that the Secretary would use in approving applications for the CMHS Block Grant have never been issued. Regulationsestablishing the criteria for the SAPT Block Grant, except for implementation of section 1926 related to tobacco, were issued onMarch 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 theregulations for the SAPT to reflect changes in statute and our experience over the past seventeen years. The regulations willemphasize consistent and effective planning, reporting and expenditure of obligations, and helping States build and maintainmore effective behavioral health systems for prevention and treatment, services and recovery supports.

Priority: Other Significant Agenda Stage of Rulemaking: Completed ActionMajor: Yes Unfunded Mandates: NoCFR 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 HealthServices (CMHS) Block Grant and the Substance Abuse Prevention and Treatment (SAPT) Block GrantLegal Deadline: None


Regulatory Flexibility Analysis Required: No Government Levels Affected: StateFederalism: YesEnergy Affected: NoAgency Contact: Joseph Denis Faha Director, DLEA, SAMHSADepartment of Health and Human ServicesSubstance Abuse and Mental Health Services Administration5600 Fishers LaneRockville , MD 20857 Phone: 301 443-7017 FAX: 301 443-1450E-Mail: [email protected]

Department of Health and Human Services (HHS) Office of the Inspector General ( OIG ) RIN: 0936-AA02


Title: Medicare and State Health Care Programs: Fraud and Abuse; Revisions to the Office of Inspector General's SafeHarbors Under the Antikickback Status, Exclusion Authorities, and Civil Monetary PenaltyAbstract: This rule would: 1) Safe Harbor Provisions: Add safe harbors under the anti-kickback statute addressingarrangements in the following areas (subject to certain conditions): waivers of Federal health care program beneficiary cost-sharing amounts in the context of certain government sponsored clinical trials and in the context of certain emergency medicalservices furnished by suppliers owned or operated by States or municipalities; certain local transportation provided to Federalhealth care program beneficiaries; certain waived or reduced cost-sharing amounts under Medicare Part D (codifying inregulations section 101(e) of the Medicare Prescription Drug Improvement and Modernization Act of 2003); and certaindiscounts in the price of "applicable drugs" of manufacturers furnished to "applicable beneficiaries" under the MedicareCoverage Gap Discount Program (pursuant to section 3301 of the Affordable Care Act of 2010). In addition, this rule would re-propose expanding the existing safe harbor for certain waivers of beneficiary co-insurance and deductible amounts for Part A orPart 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 (610Review): Revise 42 CFR part 1003, addressing the Office of Inspector General's authority to propose the imposition of civilmoney penalties and assessments by reorganizing and simplifying existing regulatory text and eliminating obsolete referencescontained in the current regulations. Among the proposed revisions, this rule would establish separate subparts within part 1003for various categories of violations; clarify the availability of exclusion for certain violations in addition to civil money penaltiesand assessments; date various references to managed care organization authorities; and clarify the application of section 1140of the Social Security Act with respect to the misuse of certain Departmental symbols, emblems, or names through Internet ande mail communications. 3) OIG's Exclusion Authority: In accordance with section 949 of the Medicare Prescription DrugImprovement and Modernization Act of 2003, and section 6402 of the Affordable care Act 0f 2010, this rule would revise theOIG's exclusion authority to permit any Federal health care program to request a waiver of an OIG exclusion imposed undersections 1128(a)(1), 1128(a)(3), or 1128(a)(4) of the Social Security Act if the exclusion would impose a hardship onbeneficiaries. In addition, in accordance with sections 6406 and 6408 of the Affordable Care Act, the proposed rule would revisethe OIG's exclusion authority to grant testimonial subpoena authority in exclusion cases; to add a new permissive exclusionauthority for making false statements or misrepresentation of materials facts, and; to broaden the scope of certain permissiveexclusion authorities. Finally, the proposed rule would revise current exclusion authorities in 42 CFR parts 1001, 1002, and1005, to further clarify OIG's existing exclusion authorities. 4) Exceptions to the Beneficiary Inducement Prohibition for CertainArrangements This proposed rule will codify section 6402(d)(2)(B) of the Affordable Care Act of 2010, entitled "Clarification ofTreatment of Certain Charitable and Other Innocuous Programs." Section 1128A(a)(5) of the Social Security Act provides for acivil monetary penalty for certain inducements offered to Medicare and Medicaid beneficiaries. Section 6402(d)(2)(B) of the ACAadds four exceptions to the definition of remuneration at section 1128A(i)(6) of the Social Security Act for purposes of section1128A(a)(5): certain remuneration which promotes access to care and poses a low risk of harm to patients and Federal healthcare 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 tobeneficiaries experiencing financial need; and certain waivers by PDP sponsors of Part D plans or MA organizations offeringMA-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 RuleMajor: Undetermined Unfunded Mandates: NoCFR Citation: 42 CFR 1001.952; 42 CFR 1001 and 1002; 42 CFR 1005; 42 CFR 1003.101; 42 CFR 1003; ... (To search for aspecific 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 105-33, sec 4331, PL 99-660; PL 107-188; 42 USC 1320a-7a; 42 USC 1395mm; 42 USC 1395w-27; 42 USC 1396bLegal Deadline:

Action Source Description Date NPRM Statutory 11/00/2011


Regulatory Flexibility Analysis Required: No Government Levels Affected: NoFederalism: NoAgency Contact: Patrice S. Drew Regulations AnalystDepartment of Health and Human ServicesOffice of the Inspector General330 Independence Avenue SW.Washington , DC 20201 Phone: 202 619-1368 E-Mail: [email protected]

Department of Health and Human Services (HHS) Office of the Inspector General ( OIG ) RIN: 0936-AA01


Title: Revision to Prohibition on FFP for "Data Mining" by Medicaid Fraud Control UnitsAbstract: 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 thescreening of claims, analysis of patterns of practice, or routine verification with recipients of whether services billed by providerswere 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 RuleMajor: No Unfunded Mandates: NoCFR 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


Regulatory Flexibility Analysis Required: No Government Levels Affected: StateFederalism: NoEnergy Affected: UndeterminedAgency Contact: Patrice S. Drew Regulations AnalystDepartment of Health and Human ServicesOffice of the Inspector General330 Independence Avenue SW.Washington , DC 20201 Phone: 202 619-1368 E-Mail: [email protected]

Department of Health and Human Services (HHS) Office of Assistant Secretary for Health ( OASH ) RIN: 0937-AA02


Title: Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, andAmbiguity for InvestigatorsAbstract: The Office of the Secretary of the Department of Health and Human Services (HHS) in coordination with the Office ofScience and Technology Policy (OSTP) issued an advance notice of proposed rulemaking (ANPRM) to request comment onhow current regulations for protecting human subjects who participate in research might be modernized and revised to be moreeffective. This ANPRM solicited comment on how to better protect human subjects who are involved in research, whilefacilitating valuable research and reducing burden, delay, and ambiguity for investigators. Revisions to the current humansubjects regulations are being considered because OSTP and HHS believe these changes would strengthen protections forresearch subjects.

Priority: Other Significant Agenda Stage of Rulemaking: Proposed RuleMajor: No Unfunded Mandates: NoCFR Citation: 45 CFR 160; 45 CFR 164; 21 CFR 56; 21 CFR 50 (To search for a specific CFR, visit the Code of FederalRegulations ) Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 360; 21 USC 371Legal Deadline: None

Timetable: Action Date FR Cite ANPRM 07/26/2011 76 FR 44512 ANPRM Comment Period End 09/26/2011 NPRM 03/00/2012

Regulatory Flexibility Analysis Required: Undetermined Government Levels Affected: UndeterminedFederalism: NoEnergy Affected: UndeterminedAgency Contact: Jerry Menikoff Department of Health and Human ServicesOffice of Assistant Secretary for Health200 Independence Ave. SWWashington , DC 20201

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Department of Health and Human Services (HHS) Office of Assistant Secretary for Health ( OASH ) RIN: 0937-AA03


Title: Public Health Service Standards for the Protection of Research Misconduct WhistleblowersAbstract: To implement section 493(e) of the Public Health Service Act (added by sec. 163 of the National Institutes of HealthRevitalization Act of 1993, Pub. L. 103-43), the Department is proposing to add a new part 94 to title 42 of the Code of FederalRegulations. Under this proposed regulation, covered institutions must follow certain requirements for preventing and respondingto occurrences of retaliation against whistleblowers. The purpose of this part is to protect: 1) Persons who make a good faithallegation that a covered institution or member thereof engaged in, or failed to respond adequately, to an allegation of researchmisconduct; and 2) persons who cooperate in good faith with an investigation of research misconduct.

Priority: Substantive, Nonsignificant Agenda Stage of Rulemaking: Completed ActionMajor: No Unfunded Mandates: NoCFR 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 241Legal Deadline: None

Timetable: Action Date FR Cite NPRM 11/28/2000 65 FR 70830 NPRM Comment Period End 01/29/2001 Withdrawn 10/25/2011

Regulatory Flexibility Analysis Required: No Government Levels Affected: NoSmall Entities Affected: No Federalism: NoRelated RINs: Related to 0940-AA04; Previously Reported as0940-AA01Agency Contact: John Dahlberg Senior ScientistDepartment of Health and Human ServicesOffice of Assistant Secretary for Health1101 Wootton ParkwayRockville , MD 20852 Phone: 301 443-5300 E-Mail: [email protected]

Department of Health and Human Services (HHS) Centers for Medicare & Medicaid Services ( CMS ) RIN: 0938-AO53


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 community-based services (HCBS) plan services under the Affordable Care Act. This proposed rule offers States new flexibilities inproviding necessary and appropriate services to elderly and disabled populations and reflects CMS' commitment to the generalprinciples of the President's Executive Order released January 18, 2011, entitled "Improving Regulation and RegulatoryReview." In particular, this rule does not include the existing cumbersome eligibility link between HCBS and institutional carethat exists under the Medicaid 1915(c) HCBS waiver program. This regulation would describe Medicaid coverage of a newoptional State plan benefit to furnish home and community based State plan services and draw Federal matching funds. As aresult, States will be better able to design and tailor Medicaid services to accommodate individual needs. This may result inimproved patient outcomes and satisfaction, while enabling States to effectively manage their Medicaid resources.

Priority: Economically Significant Agenda Stage of Rulemaking: Proposed RuleMajor: Yes Unfunded Mandates: No

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http://www.regulations.gov/public/component/main?main=RuleDocuments&agency=HHS&pubperiod=201110&rin=0938-AO53

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 Date FR Cite NPRM 04/04/2008 73 FR 18676 NPRM Comment Period End 06/03/2008 Second NPRM 02/00/2012

Additional Information: Includes Retrospective Review under E.O. 13563.

Regulatory Flexibility Analysis Required: No Government Levels Affected: StateSmall Entities Affected: Business Federalism: NoEnergy Affected: NoAgency Contact: Suzanne Bosstick Director, Division of Integrated Health SystemsDepartment of Health and Human ServicesCenters for Medicare & Medicaid Services7500 Security BoulevardBaltimore , MD 21244 Phone: 410 786-1301 E-Mail: [email protected]

Department of Health and Human Services (HHS) Centers for Medicare & Medicaid Services ( CMS ) RIN: 0938-AQ13


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 thatestablish a unique health plan identifier. This health plan identifier will be used to identify health plans in HIPAA standardtransactions.

Priority: Other Significant Agenda Stage of Rulemaking: Proposed RuleMajor: Undetermined Unfunded Mandates: UndeterminedCFR Citation: Not Yet Determined (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: PL 111-148, sec 1104Legal Deadline:



Regulatory Flexibility Analysis Required: Undetermined Government Levels Affected: UndeterminedSmall Entities Affected: Business Federalism: UndeterminedEnergy Affected: NoAgency Contact: Denise Buenning Director, Administrative Simplification Group, Office of E-Health Standards and ServicesDepartment of Health and Human ServicesCenters for Medicare & Medicaid ServicesMail Stop S2-26-17 7500 Security BoulevardBaltimore , MD 21244 Phone: 410 786-6711

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http://www.regulations.gov/public/component/main?main=RuleDocuments&agency=HHS&pubperiod=201110&rin=0938-AQ13





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 cannotexceed the uncompensated costs of furnishing hospital services by the hospital to individuals who are Medicaid-eligible or "haveno health insurance (or other source of third party coverage) for the services furnished during the year." This rule would providethat the quoted phrase would refer in context to a lack of coverage on a service-specific basis, so that the calculation ofuncompensated care for purposes of the hospital-specific Medicaid Disproportionate Share Hospital (DSH) limit would includethe cost of each service furnished to an individual who had no health insurance or other source of third party coverage for thatservice.

Priority: Other Significant Agenda Stage of Rulemaking: Proposed RuleMajor: No Unfunded Mandates: NoCFR Citation: 42 CFR 447 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: 1923(g) of the Social Security ActLegal Deadline: None


Regulatory Flexibility Analysis Required: No Government Levels Affected: StateSmall Entities Affected: Business; Governmental Jurisdictions Federalism: NoEnergy Affected: NoAgency Contact: Rory Howe Health Insurance SpecialistDepartment of Health and Human ServicesCenters for Medicare & Medicaid ServicesMail Stop S3-13-11 7500 Security BoulevardBaltimore , MD 21244 Phone: 410 786-8533 Extension: 68533 E-Mail: [email protected]



Title: Covered Outpatient Drugs (CMS-2345-P)Abstract: This proposed rule would revise requirements pertaining to Medicaid reimbursement for covered outpatient drugs toimplement provisions of the Affordable Care Act. This proposed rule would also revise other requirements related to coveredoutpatient drugs, including key aspects of Medicaid coverage, payment, and the drug rebate program.

Priority: Economically Significant Agenda Stage of Rulemaking: Proposed RuleMajor: Yes Unfunded Mandates: NoCFR Citation: 42 CFR 447 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: PL 111- 48, secs 2501 and 2503Legal Deadline:


Timetable:100







Regulatory Flexibility Analysis Required: Business Government Levels Affected: State; TribalFederalism: NoEnergy Affected: NoRelated RINs: Related to 0938-AP26; Related to 0938-AP67Agency Contact: Wendy Tuttle Health Insurance SpecialistDepartment of Health and Human ServicesCenters for Medicare & Medicaid ServicesCenter for Medicaid and State Operations Mail Stop S2-14-26 7500 Security BoulevardBaltimore , MD 21244 Phone: 410 786-8690 E-Mail: [email protected]



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 Secretaryestablish a process for a provider or supplier to return an overpayment to the program, as well as establish a process for CMSand its contractors to receive and apply the overpayment.

Priority: Other Significant Agenda Stage of Rulemaking: Proposed RuleMajor: Yes Unfunded Mandates: NoCFR 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


Regulatory Flexibility Analysis Required: No Government Levels Affected: StateSmall Entities Affected: Business Federalism: NoAgency Contact: John Spiegel Director, Program Integrity GroupDepartment of Health and Human ServicesCenters for Medicare & Medicaid ServicesMail Stop C3-02-16 7500 Security BoulevardBaltimore , MD 21244 Phone: 410 786-5704 E-Mail: [email protected]



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 StateMedicaid agencies of at least the Medicare rates in effect in calendar years (CYs) 2013 and 2014 for primary care servicesdelivered by a physician with a specialty designation of family medicine, general internal medicine, or pediatric medicine. Thisrule 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 forimplementing the enhanced payment for managed care services.

Priority: Economically Significant Agenda Stage of Rulemaking: Proposed RuleMajor: Yes Unfunded Mandates: NoCFR Citation: 42 CFR 447 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: PL 111-152, sec 1202Legal Deadline:



Regulatory Flexibility Analysis Required: No Government Levels Affected: Federal; StateFederalism: NoEnergy Affected: NoAgency Contact: Mary Cieslicki Health Insurance SpecialistDepartment of Health and Human ServicesCenters for Medicare & Medicaid ServicesMail Stop S3-14-28 7500 Security BoulevardBaltimore , MD 21244 Phone: 410 786-4576 E-Mail: [email protected]



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 Registeron July 28, 2010, specifies that CMS will expand on the criteria for meaningful use established for Stage 1 to advance the useof certified EHR technology by eligible professionals (EPs), eligible hospitals and critical access hospitals (CAHs). Thisproposed rule would establish the requirements for Stage 2. As stated in the July 28 final rule, "Our goals for the Stage 2meaningful use criteria, consistent with other provisions of Medicare and Medicaid law, expand upon the Stage 1 criteria toencourage the use of health IT for continuous quality improvement at the point of care and the exchange of information in themost 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 RuleMajor: Yes Unfunded Mandates: NoCFR Citation: 42 CFR 412; 42 CFR 413; 42 CFR 422; 42 CFR 495 (To search for a specific CFR, visit the Code of FederalRegulations ) Legal Authority: PL 111-5 secs 4101, 4102, and 4202Legal Deadline: None


Regulatory Flexibility Analysis Required: Business;Governmental Jurisdictions Government Levels Affected: State

Federalism: NoEnergy Affected: NoRelated RINs: Related to 0938-AP78; Related to 0991-AB82Agency Contact: Elizabeth Holland

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Director, Health Initiatives Group/Office of e-Health Standards and ServicesDepartment of Health and Human ServicesCenters for Medicare & Medicaid ServicesMail Stop S2-26-17 7500 Security BoulevardBaltimore , MD 21244 Phone: 410 786-1309 E-Mail: [email protected]



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 tocertify that data and information systems are in compliance with any applicable standards and associated operating rules forelectronic 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 RuleMajor: Undetermined Unfunded Mandates: UndeterminedCFR Citation: Not Yet Determined (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: PL 111-148, sec 1104Legal Deadline:


Other Statutory First phase of compliance deadline is December 31, 2013; second phaseof compliance to occur by December 31, 2015.

12/31/2013


Regulatory Flexibility Analysis Required: Undetermined Government Levels Affected: UndeterminedSmall Entities Affected: Business Federalism: UndeterminedEnergy Affected: NoAgency Contact: Denise Buenning Director, Administrative Simplification Group, Office of E-Health Standards and ServicesDepartment of Health and Human ServicesCenters for Medicare & Medicaid ServicesMail Stop S2-26-17 7500 Security BoulevardBaltimore , MD 21244 Phone: 410 786-6711 E-Mail: [email protected]



Title: Policy and Technical Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit Programs forContract Year 2013 (CMS-4157-F)Abstract: This rule sets forth programmatic and operational changes to the Medicare Advantage (MA) and prescription drugbenefit programs for contract year 2013.

Priority: Economically Significant Agenda Stage of Rulemaking: Proposed RuleMajor: Yes Unfunded Mandates: NoCFR 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; MIPPALegal Deadline: None

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Regulatory Flexibility Analysis Required: Undetermined Government Levels Affected: FederalSmall Entities Affected: Business; Governmental Jurisdictions Federalism: NoEnergy Affected: UndeterminedAgency Contact: Christian Bauer Health Insurance SpecialistDepartment of Health and Human ServicesCenters for Medicare & Medicaid ServicesMail Stop C1-26-16 7500 Security BoulevardBaltimore , MD 21244 Phone: 410 786-6043 E-Mail: [email protected]



Title: Medicare and Medicaid Programs: Reform of Hospital and Critical Access Hospital Conditions of Participation (CMS-3244-P)Abstract: This proposed rule would revise the requirements that hospitals and critical access hospitals (CAHs) must meet toparticipate in the Medicare and Medicaid programs. These changes are necessary to reflect substantial advances in health caredelivery and in patient safety knowledge and practices. They are also an integral part of our efforts to achieve broad-basedimprovements in the quality of health care furnished through Federal programs and in patient safety, while at the same timereducing procedural burdens on providers.

Priority: Economically Significant Agenda Stage of Rulemaking: Proposed RuleMajor: Yes Unfunded Mandates: NoCFR 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 1395rrLegal 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 CAHpatients in an effective and efficient manner. CMS is proposing changes to reduce unnecessary, obsolete, or burdensomeregulations on U.S. hospitals. This retrospective review of existing regulations meets the President's Executive Order that allFederal agencies identify such rules and make proposals to "modify, streamline, expand, or repeal them." CMS is alsoproposing 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 ExecutiveOrder 13563 "Improving Regulations and Regulatory Review."

Alternatives: To date, nearly 90 specific reforms have been identified and scheduled for action. These reforms impacthospitals, physicians, home health agencies, ambulance providers, clinical labs, skilled nursing facilities, intermediate carefacilities, managed care plans, Medicare Advantage organizations, and States. Many of these reforms will be included inproposed rules that relate to particular categories of regulations or types of providers. Other reforms are being implementedwithout the need for regulations. This proposed rule includes reforms that do not fit directly in other rules scheduled forpublication.

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 futuredecisions 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, areapproximately $940 million a year.


Action Date FR Cite NPRM 10/24/2011 76 FR 65891 NPRM Comment Period End 12/23/2011

Regulatory Flexibility Analysis Required: Business Government Levels Affected: NoFederalism: NoEnergy Affected: NoAgency Contact: CDR Scott Cooper Health Insurance SpecialistDepartment of Health and Human ServicesCenters for Medicare & Medicaid ServicesClinical Standards Group Mail Stop S3-05-15 7500 Security BoulevardBaltimore , MD 21244 Phone: 410 786-9465 E-Mail: [email protected]



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) underMedicaid to have an operational ethics and compliance program that is effective in promoting quality of care and preventing anddetecting criminal, civil, and administrative violations.

Priority: Other Significant Agenda Stage of Rulemaking: Proposed RuleMajor: No Unfunded Mandates: NoCFR Citation: 42 CFR 483 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: PL 111-148 6102Legal Deadline:



Regulatory Flexibility Analysis Required: No Government Levels Affected: StateSmall Entities Affected: Business Federalism: NoEnergy Affected: NoAgency Contact: Diane Corning Health Insurance SpecialistDepartment of Health and Human ServicesCenters for Medicare & Medicaid ServicesOffice of Clinical Standards and Quality Mail Stop S3-02-01 7500 Security BoulevardBaltimore , MD 21244 Phone: 410 786-8486 E-Mail: [email protected]


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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 asunnecessary, obsolete, or excessively burdensome on health care providers and beneficiaries. This proposed rule wouldincrease the ability of health care professionals to devote resources to improving patient care, by eliminating or reducingrequirements that impede quality patient care or that divert providing high quality patient care.

Priority: Economically Significant Agenda Stage of Rulemaking: Proposed RuleMajor: Yes Unfunded Mandates: NoCFR Citation: 42 CFR 400, 405, 416, 418, 423; 42 CFR 424, 440, 442, 486, 494 (To search for a specific CFR, visit the Codeof Federal Regulations ) Legal Authority: 42 USC 1302 and 1395hh and 44 USC 35Legal Deadline: None

Regulatory Plan:Statement of Need: In January 2011, the President issued an Executive order that requires agencies to identify rules thatmay be "outmoded, ineffective, insufficient, or excessively burdensome, and to modify, streamline, expand, or repeal them inaccordance with what has been learned." In accordance with the Executive order, we identified obsolete and unnecessarilyburdensome rules that could be eliminated or reformed to achieve similar objectives, with a particular focus on freeing upresources that health care providers, health plans, and States could use to improve or enhance patient health and safety. Weexamined policies and practices not codified in rules that could be changed or streamlined to achieve better outcomes forpatients while reducing burden on providers of care. We also sought to increase transparency and become a better businesspartner.

Legal Basis: The provisions that are included in this proposed rule are necessary to implement the requirements of ExecutiveOrder 13563 "Improving Regulations and Regulatory Review."

Alternatives: To date, nearly 90 specific reforms have been identified and scheduled for action. These reforms impacthospitals, physicians, home health agencies, ambulance providers, clinical labs, skilled nursing facilities, intermediate carefacilities, managed care plans, Medicare Advantage organizations, and States. Many of these reforms will be included inproposed rules that relate to particular categories of regulations or types of providers. Other reforms are being implementedwithout the need for regulations. This proposed rule includes reforms that do not fit directly in other rules scheduled forpublication.

Costs and Benefits: We anticipate that the provider industry and health professionals would welcome the proposed changesand reductions in burden. We also expect that health professionals would experience increased efficiencies and resources toappropriately devote to improving patient care, increasing accessibility to care, and reducing associated health care costs.


Action Date FR Cite NPRM 10/24/2011 76 FR 65909 NPRM Comment Period End 12/23/2011

Regulatory Flexibility Analysis Required: No Government Levels Affected: Federal; StateSmall Entities Affected: Business; Governmental Jurisdictions;Organizations Federalism: No

Agency Contact: Michelle Shortt Director, Regulations Development Group, OSORADepartment of Health and Human ServicesCenters for Medicare & Medicaid ServicesMailstop C4-26-05 7500 Security BoulevardBaltimore , MD 21244 Phone: 410 786-4675 E-Mail: [email protected]

Department of Health and Human Services (HHS) Centers for Medicare & Medicaid Services ( CMS ) RIN: 0938-AR03

View Related Documents106





http://www.regulations.gov/public/component/main?main=RuleDocuments&agency=HHS&pubperiod=201110&rin=0938-AR03

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 ruleestablishing the Qualified Health Plans and Health Benefit Exchanges as defined in the Affordable Care Act. This rule focuseson requirements for Qualified Health Plans and is more implementation-focused on elements such as the Essential HealthBenefits and oversight of the Exchanges.

Priority: Other Significant Agenda Stage of Rulemaking: Proposed RuleMajor: No Unfunded Mandates: UndeterminedCFR 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 111-148Legal Deadline:


Timetable: Action Date FR Cite Notice 09/14/2011 76 FR 56767 Comment Period End 10/31/2011 NPRM 04/00/2012

Regulatory Flexibility Analysis Required: Undetermined Government Levels Affected: Federal; Local; State; TribalSmall Entities Affected: Business; Governmental Jurisdictions;Organizations Federalism: Yes

Energy Affected: NoAgency Contact: Alissa Deboy Department of Health and Human ServicesCenters for Medicare & Medicaid Services7500 Security BoulevardBaltimore , MD 21244 Phone: 301 492-4428 E-Mail: [email protected]



Title: Medicaid Eligibility Changes Under the Affordable Care Act—Part II (CMS-2334-P)Abstract: This proposed rule would implement provisions of the Affordable Care Act of 2010. The Affordable Care Act expandsaccess 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. Thisproposed rule would set forth sections of the Affordable Care Act related to appeals, notices, and other Medicaid eligibilitychanges under the Affordable Care Act and options established by other Federal statutes.

Priority: Economically Significant Agenda Stage of Rulemaking: Proposed RuleMajor: Yes Unfunded Mandates: NoCFR 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, 2201Legal Deadline:



Regulatory Flexibility Analysis Required: Undetermined Government Levels Affected: Federal; Local; State; TribalFederalism: Undetermined

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Energy Affected: NoAgency Contact: Sarah Delone Senior. Policy AdvisorDepartment of Health and Human ServicesCenters for Medicare & Medicaid ServicesMailstop S2-01-16 7500 Security BoulevardBaltimore , MD 21244 Phone: 410 786-0615 E-Mail: [email protected]



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 applicablestatutory requirements and changes arising from our continuing experience with this system. The proposed rule also describeschanges to the amounts and factors used to determine payment rates for services. In addition, the rule proposes changes to theAmbulatory Surgical Center Payment System list of services and rates.

Priority: Economically Significant Agenda Stage of Rulemaking: Proposed RuleMajor: Yes Unfunded Mandates: UndeterminedCFR 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 ActLegal Deadline:


Regulatory Plan:Statement of Need: Medicare pays over 4,000 hospitals for outpatient department services under the hospital outpatientprospective payment system (OPPS). The OPPS is based on groups of clinically similar services called ambulatory paymentclassification groups (APCs). CMS annually revises the APC payment amounts based on the most recent claims data, proposesnew payment policies, and updates the payments for inflation using the hospital operating market basket. The proposed rulesolicits comments on the proposed OPPS payment rates and new policies. Medicare pays roughly 5,000 Ambulatory SurgicalCenters (ASCs) under the ASC payment system. CMS annually revises the payment under the ASC payment system, proposesnew policies, and updates payments for inflation using the Consumer Price Index for All Urban Consumers (CPI-U). CMS willissue a final rule containing the payment rates for the 2013 OPPS and ASC payment system at least 60 days before January1, 2013.

Legal Basis: Section 1833 of the Social Security Act establishes Medicare payment for hospital outpatient services and ASCservices. The final rule revises the Medicare hospital OPPS and ASC payment system to implement applicable statutoryrequirements. In addition, the proposed and final rules describe changes to the outpatient APC system, relative paymentweights, outlier adjustments, and other amounts and factors used to determine the payment rates for Medicare hospitaloutpatient services paid under the prospective payment system, as well as changes to the rates and services paid under theASC 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 beginningJanuary 1, 2013.Timetable:


Regulatory Flexibility Analysis Required: Business Government Levels Affected: FederalFederalism: Undetermined

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Energy Affected: NoAgency Contact: Paula Smith Health Insurance SpecialistDepartment of Health and Human ServicesCenters for Medicare & Medicaid ServicesMail Stop C4-05-13 7500 Security BlvdBaltimore , MD 21244 Phone: 410 786-4709 E-Mail: [email protected]



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 policychanges 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 RuleMajor: Yes Unfunded Mandates: UndeterminedCFR Citation: Not Yet Determined (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: Social Security Act, secs 1102, 1871, 1848Legal 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 Bpayment to physicians and other Part B suppliers. The final rule has a statutory publication date of November 1, 2012, and animplementation date of January 1, 2013.

Legal Basis: Section 1848 of the Social Security Act (the Act) establishes the payment for physician services provided underMedicare. Section 1848 of the Act imposes a deadline of no later than November 1 for publication of the final rule or finalphysician 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 Government Levels Affected: UndeterminedFederalism: UndeterminedEnergy Affected: UndeterminedAgency Contact: Christina Ritter Director, Division of Practitioner ServicesDepartment of Health and Human ServicesCenters for Medicare & Medicaid ServicesMail Stop C4-03-06 7500 Security BlvdBaltimore , MD 21244 Phone: 410 786-4636 E-Mail: [email protected]

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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 prospectivepayment systems for operating and capital-related costs. This proposed rule would implement changes arising from ourcontinuing experience with these systems.

Priority: Economically Significant Agenda Stage of Rulemaking: Proposed RuleMajor: Yes Unfunded Mandates: UndeterminedCFR 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 ActLegal Deadline:

Action Source Description Date NPRM Statutory 04/01/2012 Other Statutory 08/01/2012

Regulatory Plan:Statement of Need: CMS annually revises the Medicare hospital inpatient prospective payment systems (IPPS) for operatingand capital-related costs to implement changes arising from our continuing experience with these systems. In addition, wedescribe the proposed changes to the amounts and factors used to determine the rates for Medicare hospital inpatient servicesfor operating costs and capital-related costs. Also, CMS annually updates the payment rates for the Medicare prospectivepayment system (PPS) for inpatient hospital services provided by long-term care hospitals (LTCHs). The proposed rule solicitscomments on the proposed IPPS and LTCH payment rates and new policies. CMS will issue a final rule containing thepayment 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 hospitalinpatient stays under Medicare Part A (Hospital Insurance) based on prospectively set rates. The Act requires the Secretary topay for the capital-related costs of hospital inpatient and Long Term Care stays under a PPS. Under these systems, Medicarepayment for hospital inpatient and Long Term Care operating and capital-related costs is made at predetermined, specific ratesfor 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 beginningOctober 1, 2012.Timetable:


Regulatory Flexibility Analysis Required: Business Government Levels Affected: FederalFederalism: NoEnergy Affected: NoAgency Contact: Ankit Patel Health Insurance Specialist, Division of Acute CareDepartment of Health and Human ServicesCenters for Medicare & Medicaid ServicesHospital and Ambulatory Policy Group Mail Stop, C4-25-11 7500 Security BoulevardBaltimore , MD 21244 Phone: 410 786-4537 E-Mail: [email protected]



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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) facilitiesas required by MIPPA. These changes would be applicable to services furnished on or after January 1.

Priority: Economically Significant Agenda Stage of Rulemaking: Proposed RuleMajor: Yes Unfunded Mandates: UndeterminedCFR 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:



Regulatory Flexibility Analysis Required: Undetermined Government Levels Affected: FederalSmall Entities Affected: Business Federalism: UndeterminedEnergy Affected: NoAgency Contact: Janet Samen Director, Division of Chronic Care ManagementDepartment of Health and Human ServicesCenters for Medicare & Medicaid ServicesMail Stop C5-05-27 7500 Security BoulevardBaltimore , MD 21244 Phone: 410 786-4533 E-Mail: [email protected]



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) thatreflects local differences in wage levels.

Priority: Other Significant Agenda Stage of Rulemaking: Proposed RuleMajor: Undetermined Unfunded Mandates: UndeterminedCFR 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:



Regulatory Flexibility Analysis Required: Undetermined Government Levels Affected: UndeterminedSmall Entities Affected: Business Federalism: UndeterminedEnergy Affected: UndeterminedAgency Contact: Katherine Lucas Health Insurance SpecialistDepartment of Health and Human ServicesCenters for Medicare & Medicaid ServicesMailstop C5-08-23 7500 Security BoulevardBaltimore , MD 21244 Phone: 410 786-7723

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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 marketbasket update and case-mix adjustment. It would also update the national per-visit rates used to calculate low utilizationpayment 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.

Priority: Economically Significant Agenda Stage of Rulemaking: Proposed RuleMajor: Yes Unfunded Mandates: UndeterminedCFR 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:



Regulatory Flexibility Analysis Required: Undetermined Government Levels Affected: UndeterminedFederalism: UndeterminedEnergy Affected: UndeterminedAgency Contact: Randy Throndset Health Insurance SpecialistDepartment of Health and Human ServicesCenters for Medicare & Medicaid ServicesMailstop C5-08-17 7500 Security BoulevardBaltimore , MD 21244 Phone: 410 786-0131 E-Mail: [email protected]



Title: Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities—Update for FY 2013 (CMS-1432-P)Abstract: This rule would update the payment rates used under the prospective payment system for skilled nursing facilitiesbeginning October 1st.

Priority: Economically Significant Agenda Stage of Rulemaking: Proposed RuleMajor: Yes Unfunded Mandates: UndeterminedCFR 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:



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Regulatory Flexibility Analysis Required: Undetermined Government Levels Affected: UndeterminedFederalism: NoEnergy Affected: NoAgency Contact: Bill Ullman Center for Medicare Management, Chronic Care Policy GroupDepartment of Health and Human ServicesCenters for Medicare & Medicaid ServicesMailstop C5-06-24 7500 Security BoulevardBaltimore , MD 21244-1850 Phone: 410 786-5667 Extension: 6-5667 E-Mail: [email protected]



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 RuleMajor: Yes Unfunded Mandates: UndeterminedCFR 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 106-113Legal Deadline:



Regulatory Flexibility Analysis Required: Undetermined Government Levels Affected: UndeterminedFederalism: NoEnergy Affected: NoAgency Contact: Julie Stankivic Health Insurance SpecialistDepartment of Health and Human ServicesCenters for Medicare & Medicaid ServicesDepartment of Health and Human Services Mailstop, C5-06-27 7500 Security BoulevardBaltimore , MD 21244 Phone: 410 786-5725 E-Mail: [email protected]



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 dischargesbeginning October 1st.

Priority: Other Significant Agenda Stage of Rulemaking: Proposed RuleMajor: Undetermined Unfunded Mandates: UndeterminedCFR 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

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Legal Deadline: Action Source Description Date Other Statutory 08/01/2012


Regulatory Flexibility Analysis Required: No Government Levels Affected: LocalSmall Entities Affected: Business Federalism: NoEnergy Affected: UndeterminedAgency Contact: Janet Samen Director, Division of Chronic Care ManagementDepartment of Health and Human ServicesCenters for Medicare & Medicaid ServicesMail Stop C5-05-27 7500 Security BoulevardBaltimore , MD 21244 Phone: 410 786-4533 E-Mail: [email protected]



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 DSHallotments from FY 2014 through FY 2020. The annual reduction amounts are specified in statute and must be implementedusing a DSH Health Reform methodology determined by the Secretary. This proposed rule will delineate the DSH HealthReform methodology required to implement the reductions.

Priority: Economically Significant Agenda Stage of Rulemaking: Proposed RuleMajor: Undetermined Unfunded Mandates: NoCFR Citation: Not Yet Determined (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: PL 111-148, sec 1203Legal Deadline: The Affordable Care Act requires aggregate reductions to state Medicaid DSH allotments beginning in FY2014 (October 1, 2013).



Regulatory Flexibility Analysis Required: Undetermined Government Levels Affected: Federal; StateSmall Entities Affected: Governmental Jurisdictions Federalism: UndeterminedAgency Contact: Rory C. Howe Financial Management SpecialistDepartment of Health and Human ServicesCenters for Medicare & Medicaid ServicesMailstop S3-14-02 7500 Security BoulevardBaltimore , MD 21244 Phone: 410 786-4878 FAX: 410 786-8533E-Mail: [email protected]

Department of Health and Human Services (HHS)

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Centers for Medicare & Medicaid Services ( CMS ) RIN: 0938-AR33


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 byMedicare, Medicaid, or CHIP to report annually to the Secretary certain payments or transfers of value provided to physicians orteaching 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 publishapplicable manufacturers' and applicable GPOs' submitted payment and ownership information on a public website.

Priority: Economically Significant Agenda Stage of Rulemaking: Proposed RuleMajor: Yes Unfunded Mandates: Private SectorCFR 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 6002Legal Deadline:



Regulatory Flexibility Analysis Required: Business Government Levels Affected: NoFederalism: NoAgency Contact: Niall Brennan Director, Policy and Data Analysis GroupDepartment of Health and Human ServicesCenters for Medicare & Medicaid Services7500 Security Blvd,Baltimore, , MD 21244 Phone: 202 690-6627 E-Mail: [email protected]

Department of Health and Human Services (HHS) Centers for Medicare & Medicaid Services ( CMS ) RIN: 0938-AP64


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 "pass-through price" or the "lock-in price" when reporting Part D drug cost data.

Priority: Other Significant Agenda Stage of Rulemaking: Final RuleMajor: No Unfunded Mandates: NoCFR 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 1395hhLegal Deadline:

Action Source Description Date Other Statutory MMA section 902 01/12/2012


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http://www.regulations.gov/public/component/main?main=RuleDocuments&agency=HHS&pubperiod=201110&rin=0938-AP64


Regulatory Flexibility Analysis Required: No Government Levels Affected: NoSmall Entities Affected: Business Federalism: NoAgency Contact: James Slade Health Insurance SpecialistDepartment of Health and Human ServicesCenters for Medicare & Medicaid ServicesMail Stop C1-13-15 7500 Security BoulevardBaltimore , MD 21244 Phone: 410 786-1073 E-Mail: [email protected]



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 requirethe adoption of standards for Electronic Funds Transfers (EFT).

Priority: Economically Significant Agenda Stage of Rulemaking: Final RuleMajor: Yes Unfunded Mandates: NoCFR Citation: Not Yet Determined (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: PL 111-148, sec 1104Legal Deadline:


Timetable: Action Date FR Cite Interim Final Rule 01/00/2012

Regulatory Flexibility Analysis Required: Undetermined Government Levels Affected: UndeterminedSmall Entities Affected: Business Federalism: NoEnergy Affected: NoAgency Contact: Denise Buenning Director, Administrative Simplification Group, Office of E-Health Standards and ServicesDepartment of Health and Human ServicesCenters for Medicare & Medicaid ServicesMail Stop S2-26-17 7500 Security BoulevardBaltimore , MD 21244 Phone: 410 786-6711 E-Mail: [email protected]



Title: Medicaid and Children's Health Insurance Programs; Disallowance of Claims for FFP and Technical Corrections (CMS-2292-F)Abstract: This rule reflects the Centers for Medicare and Medicaid Services' commitment to the general principles of thePresident's Executive Order 13563 released January 18, 2011, entitled "Improving Regulation and Regulatory Review," as thisrule will: (1) Implement a new reconsideration process for administrative determinations to disallow claims for Federal financialparticipation (FFP) under title XIX of the Act (Medicaid); (2) lengthen the time States have to credit the Federal Government foridentified but uncollected Medicaid provider overpayments; (3) make conforming changes to the Medicaid and Children's HealthInsurance Program (CHIP) disallowance process to allow States the option to retain disputed Federal funds through the newadministrative reconsideration process; (4) revise installment repayment standards and schedules for States that owe significantamounts; (5) clarify that interest charges may accrue during the new administrative reconsideration process if a State chooses

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to retain the funds during that period. This rule also makes a technical correction to reporting requirements for disproportionateshare 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 RuleMajor: No Unfunded Mandates: NoCFR Citation: 42 CFR 430; 42 CFR 433; 42 CFR 447; 42 CFR 457 (To search for a specific CFR, visit the Code of FederalRegulations ) Legal Authority: 42 USC 1316; PL 111-148; PL 110-275Legal Deadline:




Regulatory Flexibility Analysis Required: No Government Levels Affected: StateFederalism: NoAgency Contact: Robert Lane Financial Management SpecialistDepartment of Health and Human ServicesCenters for Medicare & Medicaid ServicesMail Stop S3-14-16 7500 Security BoulevardBaltimore , MD 21244 Phone: 410 786-2015 Extension: 62015 E-Mail: [email protected]



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 providehome and community-based attendant services and supports. These services and supports may be offered through theCommunity First Choice State plan option.

Priority: Economically Significant Agenda Stage of Rulemaking: Final RuleMajor: Yes Unfunded Mandates: NoCFR 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 1205Legal Deadline:



Regulatory Flexibility Analysis Required: No Government Levels Affected: StateSmall Entities Affected: Business Federalism: NoEnergy Affected: No

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Agency Contact: Melissa Harris Technical DirectorDepartment of Health and Human ServicesCenters for Medicare & Medicaid ServicesCenter for Medicaid, CHIP and Survey & Certification S2-14-26 7500 Security BoulevardBaltimore , MD 21244 Phone: 410 786-3397 E-Mail: [email protected]



Title: Face-to-Face Requirements for Home Health Services; Policy Changes and Clarifications Related to Home Health (CMS-2348-F)Abstract: This rule revises the Medicaid home health service definition as required by section 6407 of the Affordable Care Actof 2010 to add a requirement that physicians document the existence of a face-to-face encounter (including through the use oftelehealth) with the Medicaid eligible individual within reasonable timeframes. This aligns the timeframes with similar regulatoryrequirements 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 "ImprovingRegulation and Regulatory Review." In addition, this rule amends home health services regulations at section 440.70 to clarifythe definitions of included medical supplies, equipment and appliances, and clarify that States may not limit home healthservices to services delivered in the home, or to services furnished to individuals who are homebound.

Priority: Economically Significant Agenda Stage of Rulemaking: Final RuleMajor: Yes Unfunded Mandates: NoCFR 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:




Regulatory Flexibility Analysis Required: No Government Levels Affected: StateSmall Entities Affected: No Federalism: NoEnergy Affected: NoAgency Contact: Melissa Harris Technical DirectorDepartment of Health and Human ServicesCenters for Medicare & Medicaid ServicesCenter for Medicaid, CHIP and Survey & Certification S2-14-26 7500 Security BoulevardBaltimore , MD 21244 Phone: 410 786-3397 E-Mail: [email protected]



Title: Review and Approval Process for Section 1115 Demonstrations (CMS-2325-F)118





Abstract: This final rule will implement provisions of the Affordable Care Act of 2010 that set forth transparency and publicnotice procedures for experimental, pilot, and demonstration projects approved under section 1115 of the Social Security Actrelating to Medicaid and the Children's Health Insurance Program (CHIP). This rule will increase the degree to whichinformation about Medicaid and CHIP demonstration applications and approved demonstration projects is publicly available andpromote greater transparency in the review and approval of demonstrations. It will also codify existing statutory requirementspertaining to seeking advice from Indian health care providers and urban Indian organizations for section 1115 demonstrationprojects, and for the first time impose as regulatory requirements tribal consultation standards that were previously onlypublished as guidance documents.

Priority: Other Significant Agenda Stage of Rulemaking: Final RuleMajor: No Unfunded Mandates: NoCFR Citation: 42 CFR 431 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: PL 111-148, sec 10201Legal Deadline:



Regulatory Flexibility Analysis Required: No Government Levels Affected: StateSmall Entities Affected: No Federalism: NoEnergy Affected: NoAgency Contact: Steven Rubio Health Insurance SpecialistDepartment of Health and Human ServicesCenters for Medicare & Medicaid ServicesMail Stop S2-01-16 7500 Security BoulevardBaltimore , MD 21244 Phone: 410 786-1782 E-Mail: [email protected]



Title: Emergency Medical Treatment and Labor Act: Applicability to Hospital Inpatients and Hospitals with SpecializedCapabilities (CMS-1350-N)Abstract: This notice addresses the applicability of Emergency Medical Treatment and Labor Act (EMTALA) to hospitalinpatients and the responsibilities of hospitals with specialized capabilities.

Priority: Other Significant Agenda Stage of Rulemaking: Final RuleMajor: No Unfunded Mandates: NoCFR Citation: 42 CFR 489 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: 42 USC 1395cc; 42 USC 1395ddLegal Deadline: None

Timetable: Action Date FR Cite ANPRM 12/23/2010 75 FR 80762 ANPRM Comment Period End 02/22/2011 Notice 01/00/2012

Regulatory Flexibility Analysis Required: No Government Levels Affected: NoSmall Entities Affected: No Federalism: No

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Related RINs: Related to 0938-AM34; Related to 0938-AP15Agency Contact: Tzvi Hefter Division DirectorDepartment of Health and Human ServicesCenters for Medicare & Medicaid ServicesCenters for Medicare Management Mail Stop, C4-07-07 7500 Security BoulevardBaltimore , MD 21244 Phone: 410 786-0614 E-Mail: [email protected]



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 "assurethat payments are consistent with efficiency, economy, and quality of care and are sufficient to enlist enough providers so thatcare and services are available under the plan at least to the extent that such care and services are available to the generalpopulation in the geographic area" as required by section 1902(a)(30)(A) of the Social Security Act (the Act). This rule alsorecognizes, as States have requested, electronic publication as an optional means of communicating State plan amendments(SPAs) proposed rate-setting policy changes to the public.

Priority: Other Significant Agenda Stage of Rulemaking: Final RuleMajor: No Unfunded Mandates: NoCFR 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 ActLegal Deadline: None


Regulatory Flexibility Analysis Required: No Government Levels Affected: StateSmall Entities Affected: No Federalism: NoEnergy Affected: NoAgency Contact: Jeremy Silanskis Health Insurance SpecialistDepartment of Health and Human ServicesCenters for Medicare & Medicaid ServicesCenter for Medicaid and State Operations Mail Stop S3-13-15 7500 Security BoulevardBaltimore , MD 21244 Phone: 410 786-1592 FAX: 410 786-8533E-Mail: [email protected]



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 throughimprovements in Medicaid, the establishment of American Health Benefit Exchanges ("Exchanges"), and coordination betweenMedicaid, the Children's Health Insurance Program (CHIP), and Exchanges. This rule also implements sections of theAffordable Care Act related to Medicaid eligibility, enrollment simplification, and coordination.

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Priority: Economically Significant Agenda Stage of Rulemaking: Final RuleMajor: Yes Unfunded Mandates: NoCFR 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, 2201Legal Deadline:


Regulatory Plan:Statement of Need: This rule expands Medicaid eligibility, simplifies Medicaid eligibility procedures, and streamlines Medicaidenrollment processes. It also coordinates eligibility processes and policies with the processes for premium tax credits forExchange coverage. Millions of uninsured low-income persons who do not have access to, or could not afford, health insurancewill 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.


Costs and Benefits: We anticipate that this rule provides significant benefits to low-income individuals by expanding theavailability 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 thelonger term.



Regulatory Flexibility Analysis Required: Undetermined Government Levels Affected: Federal; Local; State; TribalSmall Entities Affected: Governmental Jurisdictions Federalism: NoEnergy Affected: NoAgency Contact: Sarah DeLone Health Insurance SpecialistDepartment of Health and Human ServicesCenters for Medicare & Medicaid ServicesMail Stop S2-01-16 7500 Security BoulevardBaltimore , MD 21244 Phone: 410 786-0615 E-Mail: [email protected]



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 AffordableCare Act of 2010, referred to collectively as the Affordable Care Act. The Exchanges will provide competitive marketplaces forindividuals and small employers to directly compare available private health insurance options on the basis of price, quality, andother factors. The Exchanges, which will become operational by January 1, 2014, will help enhance competition in the healthinsurance market, improve choice of affordable health insurance, and give small businesses the same purchasing clout as largebusinesses.

Priority: Economically Significant Agenda Stage of Rulemaking: Final RuleMajor: Yes Unfunded Mandates: NoCFR 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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Regulatory Plan:Statement of Need: A central aim of Title I of the Affordable Care Act is to expand access to health insurance coveragethrough 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 costof their care to health care providers. Providers pass much of this cost to insurance companies, resulting in higher premiumsthat make insurance unaffordable to even more people. The Affordable Care Act includes a number of policies to address theseproblems, 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 Actof 2010.


Costs and Benefits: This rule will help enhance competition in the health insurance market, promote the choice of affordablehealth insurance, and give small businesses the same purchasing clout as large businesses. States seeking to operate anExchange will incur administrative expenses as a result of implementing and subsequently maintaining Exchanges. There is noFederal 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 thestatute.Timetable:


Regulatory Flexibility Analysis Required: Undetermined Government Levels Affected: Federal; State; TribalSmall Entities Affected: Business; Governmental Jurisdictions Federalism: YesEnergy Affected: NoAgency Contact: Alissa DeBoy Department of Health and Human ServicesDepartment of Health and Human ServicesCenters for Medicare & Medicaid Services7500 Security BoulevardBaltimore , MD 21244 Phone: 301 492-4428 E-Mail: [email protected]



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 healthinsurance issuers in compiling and providing a summary of benefits and coverage explanation that accurately describes benefitsand coverage. The Secretary must also set standards for the definitions of terms used in health insurance coverage, includingspecific terms set out in the statute. Plans and issuers must provide information according to these standards no later than 24months after enactment. This rule implements the information disclosure provisions in section 2715 of the Public Health ServiceAct, as added by the Affordable Care Act.

Priority: Other Significant Agenda Stage of Rulemaking: Final RuleMajor: No Unfunded Mandates: NoCFR 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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Regulatory Flexibility Analysis Required: Undetermined Government Levels Affected: UndeterminedFederalism: NoEnergy Affected: UndeterminedAgency Contact: Jacob Ackerman Program AnalystDepartment of Health and Human ServicesCenters for Medicare & Medicaid Services7500 Security BoulevardBaltimore , MD 21244 Phone: 301 492-4262 E-Mail: [email protected]



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. Thisregulation provides a process for public notice and comment at the State level, including public hearings, sufficient to ensure ameaningful level of public input; a process for the submission of an application that ensures the disclosure of the provisions oflaw that the state involved seeks to waive and the specific plans of the State to ensure that the waiver will be in compliance withsubsection (b) of section 1332 of the Affordable Care Act; a process for providing public notice and comment after theapplication is received by the Secretary, that is sufficient to ensure a meaningful level of public input and that does not imposerequirements that are in addition to, or duplicative of, requirements imposed under the Administrative Procedures Act, orrequirements that are unreasonable or unnecessarily burdensome with respect to state compliance; a process for thesubmission 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 RuleMajor: No Unfunded Mandates: NoCFR Citation: 45 CFR 155 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: PL 111-148Legal Deadline:



Regulatory Flexibility Analysis Required: No Government Levels Affected: StateFederalism: NoRelated Agencies: Joint : TREASAgency Contact: Ben Walker Health Insurance SpecialistDepartment of Health and Human ServicesCenters for Medicare & Medicaid Services

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Department of Treasury 7500 Security BoulevardBaltimore , MD 21244 Phone: 301 492-4148 E-Mail: ben.walker@ cms.hhs.gov



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 CareAct. The rule defines "student health insurance coverage" as a type of individual health insurance coverage, and exempts suchcoverage from certain requirements otherwise applicable to individual health insurance coverage.

Priority: Other Significant Agenda Stage of Rulemaking: Final RuleMajor: No Unfunded Mandates: NoCFR Citation: 45 CFR 144; 45 CFR 147 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: PL 111-148Legal Deadline: None


Regulatory Flexibility Analysis Required: No Government Levels Affected: FederalFederalism: NoEnergy Affected: NoAgency Contact: Gary Cohen Director, Oversight GroupDepartment of Health and Human ServicesCenters for Medicare & Medicaid Services7500 Security BoulevardBaltimore , MD 21244 Phone: 301 492-4117 E-Mail: [email protected]



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 requirethe adoption of operating rules for Electronic Funds Transfer (EFT) and Remittance Advice, and to consideration of thoseoperating rules developed by a qualified nonprofit entity that meets specific criteria.

Priority: Other Significant Agenda Stage of Rulemaking: Final RuleMajor: No Unfunded Mandates: UndeterminedCFR Citation: Not Yet Determined (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: PL 111-148, sec 1104Legal Deadline:


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Regulatory Flexibility Analysis Required: Undetermined Government Levels Affected: UndeterminedFederalism: UndeterminedEnergy Affected: NoAgency Contact: Denise Buenning Director, Administrative Simplification Group, Office of E-Health Standards and Services, CMSDepartment of Health and Human ServicesCenters for Medicare & Medicaid ServicesMail Stop S2-26-17 7500 Security BoulevardBaltimore , MD 21244 Phone: 410 786-6711 Extension: 66711 E-Mail: [email protected]



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 RuleMajor: Yes Unfunded Mandates: NoCFR 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 1342Legal Deadline:


Regulatory Plan:Statement of Need: This rule finalizes guidelines for the transitional risk-sharing programs, reinsurance and risk corridors, aswell as for the risk adjustment program that will continue beyond the first 3 years of Exchange operation. The purpose of theseprograms is to protect health insurance issuers from the negative effects of adverse selection and to protect consumers fromincreases 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 Actof 2010.


Costs and Benefits: Payments through reinsurance, risk adjustment, and risk corridors reduce the increased risk of financialloss that health insurance issuers might otherwise expect to incur in 2014 due to market reforms such as guaranteed issue andthe elimination of medical underwriting. These payments reduce the risk to the issuer and the issuer can pass on a reduced riskpremium to enrollees. Administrative costs will vary across States and health insurance issuers depending on the sophisticationof technical infrastructure and prior experience with data collection and risk adjustment. States and issuers that already havesystems 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 thestatute.Timetable:


Regulatory Flexibility Analysis Required: Undetermined Government Levels Affected: State125




Small Entities Affected: Governmental Jurisdictions Federalism: YesEnergy Affected: UndeterminedAgency Contact: Alissa Deboy Health Insurance Specialist, Center for Consumer Information & Insurance OversightDepartment of Health and Human ServicesCenters for Medicare & Medicaid Services7500 Security BoulevardBaltimore , MD 21244 Phone: 301 492-4428 E-Mail: [email protected]



Title: Inpatient Hospital Deductible and Hospital and Extended Care Services Coinsurance Amounts for CY 2013 (CMS-8046-N)Abstract: This notice announces the inpatient hospital deductible and the hospital and extended care services coinsuranceamounts for services furnished in calendar year 2013 under Medicare's Hospital Insurance program (Medicare Part A). TheMedicare statute specifies the formulae used to determine these amounts.

Priority: Other Significant Agenda Stage of Rulemaking: Final RuleMajor: Undetermined Unfunded Mandates: NoCFR 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:



Regulatory Flexibility Analysis Required: No Government Levels Affected: NoSmall Entities Affected: No Federalism: NoEnergy Affected: NoAgency Contact: Clare McFarland Deputy Director, Medicare and Medicaid Cost Estimates GroupDepartment of Health and Human ServicesCenters for Medicare & Medicaid ServicesOffice of the Actuary 7500 Security Boulevard N3-26-00Baltimore , MD 21244 Phone: 410 786-6390 E-Mail: [email protected]



Title: Part A Premiums for CY 2013 for the Uninsured Aged and for Certain Disabled Individuals Who Have Exhausted OtherEntitlement (CMS-8047-N)Abstract: This notice announces the Hospital Insurance premium for calendar year 2013 under Medicare's Hospital Insuranceprogram (Medicare Part A) for the uninsured aged and for certain disabled individuals who have exhausted other entitlement.

Priority: Other Significant Agenda Stage of Rulemaking: Final RuleMajor: Undetermined 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, sec1818A(d)(2)Legal Deadline:



Regulatory Flexibility Analysis Required: No Government Levels Affected: NoSmall Entities Affected: No Federalism: NoEnergy Affected: NoAgency Contact: Clare McFarland Deputy Director, Medicare and Medicaid Cost Estimates GroupDepartment of Health and Human ServicesCenters for Medicare & Medicaid ServicesOffice of the Actuary 7500 Security Boulevard N3-26-00Baltimore , MD 21244 Phone: 410 786-6390 E-Mail: [email protected]



Title: Part B Monthly Actuarial Rates, Monthly Premium Rates, and Annual Deductible Beginning January 1, 2013 (CMS-8048-N)Abstract: This notice announces the monthly actuarial rates for aged (age 65 and over) and disabled (under age 65) enrolleesin 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 RuleMajor: Undetermined Unfunded Mandates: NoCFR 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 5111Legal Deadline:



Regulatory Flexibility Analysis Required: No Government Levels Affected: NoSmall Entities Affected: No Federalism: NoEnergy Affected: NoAgency Contact: Suzanne Codespote Deputy Director, Medicare and Medicaid Cost Estimates GroupDepartment of Health and Human ServicesCenters for Medicare & Medicaid ServicesOffice of the Actuary 7500 Security Boulevard Mail Stop N3-26-00Baltimore , 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 anti-kickback statute, and certain civil monetary penalties (CMP) law provisions to specified financial arrangements involvingaccountable care organizations (ACOs) under the Medicare Shared Savings Program. The Affordable Care Act authorizes theSecretary to waive certain fraud and abuse laws as necessary to carry out the provisions of section 1899 of the Act (theMedicare Shared Savings Program).

Priority: Other Significant Agenda Stage of Rulemaking: Final RuleMajor: No Unfunded Mandates: NoCFR Citation: Not Yet Determined (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: PL 111-148 sec 3022Legal Deadline:


Timetable: Action Date FR Cite Interim Final Rule 11/02/2011 76 FR 67992 Interim Final Rule Comment Period End 01/01/2012

Regulatory Flexibility Analysis Required: Undetermined Government Levels Affected: FederalSmall Entities Affected: Organizations Federalism: NoAgency Contact: Troy Barsky Director, Division of Technical Payment PolicyDepartment of Health and Human ServicesCenters for Medicare & Medicaid ServicesMail Stop C4-25-05 7500 Security BoulevardBaltimore , MD 21244 Phone: 410 786-8873 E-Mail: [email protected]



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 carefacilities 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 ActionMajor: No Unfunded Mandates: NoCFR Citation: 42 CFR 483 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: 42 USC 1302; 42 USC 1395hhLegal Deadline:

Action Source Description Date Other Statutory MMA sec 902 10/22/2013








Federalism: NoEnergy Affected: NoAgency Contact: Kadie Thomas Health Insurance SpecialistDepartment of Health and Human ServicesCenters for Medicare & Medicaid ServicesOffice of Clinical Standards and Quality Mail Stop S3-02-01 7500 Security BoulevardBaltimore , MD 21244 Phone: 410 786-0468 E-Mail: [email protected] Contact: Diane Corning Health Insurance SpecialistDepartment of Health and Human ServicesCenters for Medicare & Medicaid ServicesOffice of Clinical Standards and Quality Mail Stop S3-02-01 7500 Security BoulevardBaltimore , MD 21244 Phone: 410 786-8486 E-Mail: [email protected]



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 thatCMHCs furnish services meeting essential health and safety standards. The rule focuses on patient-centered and outcome-oriented care and is based on four core requirements: 1) Patient's rights; 2) admission, assessment, and discharge; 3) treatmentand coordination of services; and 4) governance.

Priority: Other Significant Agenda Stage of Rulemaking: Long-term ActionMajor: No Unfunded Mandates: NoCFR 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 hhLegal Deadline:



Regulatory Flexibility Analysis Required: No Government Levels Affected: NoSmall Entities Affected: Business Federalism: NoEnergy Affected: NoAgency Contact: Mary Rossi-Coajou Health Insurance SpecialistDepartment of Health and Human ServicesCenters for Medicare & Medicaid ServicesOffice of Clinical Standards & Quality Mail Stop, S3-02-01 7500 Security BoulevardBaltimore , MD 21244 Phone: 410 786-6051 E-Mail: [email protected]


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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 undersection 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 person-centered plans of care, to provide characteristics of settings that are not home and community-based, to clarify the timing ofamendments 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 section1915(c) of the Act.

Priority: Other Significant Agenda Stage of Rulemaking: Long-term ActionMajor: No Unfunded Mandates: NoCFR Citation: 42 CFR 441 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: 42 USC 1302Legal Deadline: None

Timetable: Action Date FR Cite Final Action 00/00/0000 ANPRM 06/22/2009 74 FR 29453 ANPRM Comment Period End 08/21/2009 NPRM 04/15/2011 76 FR 21311 NPRM Comment Period End 06/14/2011

Regulatory Flexibility Analysis Required: No Government Levels Affected: StateFederalism: NoEnergy Affected: NoAgency Contact: Kathy Poisal Health Insurance SpecialistDepartment of Health and Human ServicesCenters for Medicare & Medicaid ServicesCenters for Medicaid State Operations Mail Stop S2-14-26 7500 Security BoulevardBaltimore , MD 21244 Phone: 410 786-5940 E-Mail: [email protected]



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 healthagencies (HHAs), and provides a number of sanctions that may be imposed when HHAs are out of compliance with Federalrequirements. This rule is necessary to implement changes in OBRA '87 in section 1891 of the Social Security Act. The rulewould emphasize quality of care, health, and safety for patients receiving home health services. The goal is to move systemsaway from a simple test of compliance to one geared toward quality services provided to patients.

Priority: Other Significant Agenda Stage of Rulemaking: Long-term ActionMajor: Undetermined Unfunded Mandates: UndeterminedCFR 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 100-203Legal Deadline: None


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Regulatory Flexibility Analysis Required: No Government Levels Affected: NoFederalism: NoEnergy Affected: NoAgency Contact: Debora Terkay Health Insurance SpecialistDepartment of Health and Human ServicesCenters for Medicare & Medicaid ServicesMail Stop S2-02-38 7500 Security BoulevardBaltimore , MD 21244 Phone: 410 786-6835 E-Mail: [email protected]



Title: Changes in Provider and Supplier Enrollment, Ordering and Referring, and Documentation Requirements; and Changesin Provider Agreements (CMS-6010-F)Abstract: This final rule implements several provisions set forth in the Affordable Care Act. Specifically, the rule requiresproviders and suppliers under the Medicare and Medicaid programs that qualify for a national provider identifier (NPI) to includetheir NPI on all applications to enroll in such programs and all claims for payment submitted under such programs. The rulealso requires, that physician and nonphysician practitioners (NPP) who are eligible to order and refer services for Medicarebeneficiaries be enrolled in Medicare and adds requirements for physicians to provide documentation on referrals to programsat high risk of waste and abuse.

Priority: Other Significant Agenda Stage of Rulemaking: Long-term ActionMajor: No Unfunded Mandates: NoCFR Citation: 42 CFR 424 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: 42 USC 1302 and 1395hhLegal Deadline:




Regulatory Flexibility Analysis Required: No Government Levels Affected: NoFederalism: NoAgency Contact: John Spiegel Director, Medicare Program of Integrity GroupDepartment of Health and Human ServicesCenters for Medicare & Medicaid ServicesCenter for Program Integrity Mail Stop B3-01-14 7111 Security BoulevardBaltimore , MD 21244 Phone: 410 786-5704 FAX: 410 786-0035E-Mail: [email protected]



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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 tospecify that, upon a patient's request, the laboratory may provide access to completed test reports that, using the laboratory'sauthentication process, can be identified as belonging to that patient. Subject to conforming amendments, the rule retains theexisting provisions that provide for release of test reports to authorized persons and, if applicable, the individuals (or theirpersonal representative) responsible for using the test reports and, in the case of reference laboratories, the laboratory thatinitially 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 theexceptions for CLIA-certified laboratories and CLIA-exempt laboratories from the provision that provides individuals with theright of access to their protected health information.

Priority: Other Significant Agenda Stage of Rulemaking: Long-term ActionMajor: No Unfunded Mandates: NoCFR Citation: 42 CFR 493; 45 CFR 164 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: 42 USC 263aLegal Deadline: None

Timetable: Action Date FR Cite Final Action 00/00/0000 NPRM 09/14/2011 76 FR 56712 ANPRM Comment Period End 11/14/2011


Regulatory Flexibility Analysis Required: Undetermined Government Levels Affected: StateSmall Entities Affected: Business; Governmental Jurisdictions Federalism: NoEnergy Affected: NoAgency Contact: Judith Yost Director, Division of Laboratory ServicesDepartment of Health and Human ServicesCenters for Medicare & Medicaid Services7500 Security BoulevardBaltimore , MD 21244-1850 Phone: 410 786-3531 E-Mail: [email protected]



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 agenctsto provide DMEPOS supplies unless prohibited by state law, remove the requirement for compliance with local zoning laws, andmodify certain state licensing requirement exceptions.

Priority: Other Significant Agenda Stage of Rulemaking: Long-term ActionMajor: No Unfunded Mandates: NoCFR 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 1871Legal Deadline:



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Final Action 04/00/2014

Regulatory Flexibility Analysis Required: No Government Levels Affected: NoSmall Entities Affected: Business Federalism: NoRelated RINs: Related to 0938-AO90Agency Contact: Frank Whelan Health Insurance SpecialistDepartment of Health and Human ServicesCenters for Medicare & Medicaid ServicesOffice of Financial Management Mailstop C3-02-16 7500 Security BoulevardBaltimore , MD 21244 Phone: 410 786-1302 E-Mail: [email protected]



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 individualhealth insurance coverage provide benefits for and prohibit the imposition of cost-sharing requirements with respect to certainrecommended evidence-based items or services. This rule finalizes the requirements and responds to any comments as theresult of the interim final rule implementing this provision.

Priority: Other Significant Agenda Stage of Rulemaking: Long-term ActionMajor: No Unfunded Mandates: NoCFR Citation: 45 CFR 156 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: PL 111-148Legal Deadline: None

Timetable: Action Date FR Cite Next Action Undetermined Interim Final Rule 07/19/2010 75 FR 41726 Interim Final Rule Comment Period End 09/10/2010 2nd Interim Final Rule 08/03/2011 76 FR 46621 2nd Interim Final Rule Comment Period End 09/30/2011

Regulatory Flexibility Analysis Required: No Government Levels Affected: NoSmall Entities Affected: Business Federalism: NoEnergy Affected: NoRelated Agencies: Joint : DOL; Joint : TREASAgency Contact: James Mayhew Health Insurance SpecialistDepartment of Health and Human ServicesCenters for Medicare & Medicaid Services7500 Security BoulevardBaltimore , MD 21244 Phone: 301 492-4113 E-Mail: [email protected]



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 otherdisclosable parties. These requirements were initially proposed in the Skilled Nursing Facilities for FY 2012 proposed rulepublished on May 6, 2011.

Priority: Other Significant Agenda Stage of Rulemaking: Long-term ActionMajor: No Unfunded Mandates: NoCFR Citation: 42 CFR 424.502; 42 CFR 424.516; 42 CFR 455.101; 42 CFR 455.104 (To search for a specific CFR, visit theCode of Federal Regulations ) Legal Authority: PL 111-148, sec 6101Legal Deadline:


Other Statutory ACA Sec 6101 requires the promulgation of a regulation within twoyears after the ACA

03/23/2012


Regulatory Flexibility Analysis Required: No Government Levels Affected: StateSmall Entities Affected: Business; Governmental Jurisdictions Federalism: NoRelated RINs: Split From 0938-AQ29Agency Contact: Sandra Bastinelli Health Insurance SpecialistDepartment of Health and Human ServicesCenters for Medicare & Medicaid ServicesMailstop B3-01-14 7500 Security BoulevardBaltimore , MD 21244 Phone: 410 786-3630 E-Mail: [email protected]

Department of Health and Human Services (HHS) Centers for Medicare & Medicaid Services ( CMS ) RIN: 0938-AJ17


Title: Medicare Changes in Conditions of Participation Requirements and Payment Provisions for Rural Health Clinics andFederally 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 thefinal rule that was published on December 24, 2003, but was subsequently suspended. This final rule amends the Medicarecertification requirements for rural health clinics (RHCs), as required by section 4205 of the Balanced Budget Act of 1997. Itupdates the regulations pertaining to RHC staffing requirements, allows RHCs to contract with RHC nonphysician providers, andrevises the RHC and Federally Qualified Health Center (FQHC) payment methodology.

Priority: Other Significant Agenda Stage of Rulemaking: Completed ActionMajor: No Unfunded Mandates: NoCFR 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 6083Legal Deadline:

Action Source Description Date Other Statutory MMA Section 902 06/27/2011

Timetable: Action Date FR Cite NPRM 02/28/2000 65 FR 10450 NPRM Comment Period End 04/28/2000 Final Rule 12/24/2003 68 FR 74791 Interim Final Rule 09/22/2006 71 FR 55341 Interim Final Rule Comment Period End 11/21/2006 Second NPRM 06/27/2008 73 FR 36463 Second NPRM Comment Period End 08/26/2008

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http://www.regulations.gov/public/component/main?main=RuleDocuments&agency=HHS&pubperiod=201110&rin=0938-AJ17


Withdrawn 06/27/2011

Regulatory Flexibility Analysis Required: No Government Levels Affected: FederalSmall Entities Affected: Business Federalism: NoEnergy Affected: NoAgency Contact: John Warren Health Insurance SpecialistDepartment of Health and Human ServicesCenters for Medicare & Medicaid ServicesCenters for Medicare Management Mail Stop C4-01-15 7500 Security BoulevardBaltimore , MD 21244 Phone: 410 786-3633 E-Mail: [email protected]

Department of Health and Human Services (HHS) Centers for Medicare & Medicaid Services ( CMS ) RIN: 0938-AJ96


Title: Use of Restraints and Seclusion in Residential Treatment Facilities Providing Inpatient Psychiatric Services to IndividualsUnder Age 21 (CMS-2065-F)Abstract: This final rule addresses standards of practice that residential treatment facilities providing inpatient psychiatricservices for individuals under age 21 must meet with regard to the use of restraints (including psychoactive drugs) andseclusion.

Priority: Other Significant Agenda Stage of Rulemaking: Completed ActionMajor: No Unfunded Mandates: NoCFR 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 1396dLegal Deadline: None

Timetable: Action Date FR Cite Interim Final Rule 01/22/2001 66 FR 7148 Interim Final Rule Effective 03/23/2001 Interim Final Rule Comment Period End 03/23/2001 60-Day Delay of Effective Date to 05/22/2001 03/21/2001 66 FR 15800 Interim Final Rule Amendment With Clarification 05/22/2001 66 FR 28110 Interim Final Rule Comment Period End 07/23/2001 Withdrawn 10/24/2011

Regulatory Flexibility Analysis Required: No Government Levels Affected: NoSmall Entities Affected: Business Federalism: NoEnergy Affected: NoAgency Contact: Thomas Shenk Health Insurance SpecialistDepartment of Health and Human ServicesCenters for Medicare & Medicaid ServicesDivision of Benefits and Coverage Policy Mail Stop S2-14-26 7500 Security BoulevardBaltimore , MD 21244 Phone: 410 786-3295 E-Mail: [email protected]



Title: Medical Improvement Eligibility Group and Definition of Work (CMS-2143-P)135


http://www.regulations.gov/public/component/main?main=RuleDocuments&agency=HHS&pubperiod=201110&rin=0938-AJ96



Abstract: This proposed rule would codify in regulations certain statutory provisions established under the Balanced Budget Actof 1997 and the Ticket to Work and Work Incentives Improvement Act of 1999 (TWWIIA). These statutory provisions allowStates 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 "severemedically determinable impairment" under the TWWIIA.

Priority: Other Significant Agenda Stage of Rulemaking: Completed ActionMajor: No Unfunded Mandates: NoCFR 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 IncentivesImprovement Act of 1999Legal Deadline: None


Regulatory Flexibility Analysis Required: No Government Levels Affected: StateSmall Entities Affected: No Federalism: NoEnergy Affected: NoAgency Contact: Joseph Razes Technical Director, Disabled and Elderly Health Program Group Div. of Advocacy and Special IssuesDepartment of Health and Human ServicesCenters for Medicare & Medicaid ServicesCenter for Medicaid and State Operations Mail Stop, S2-14-26 7500 Security BoulevardBaltimore , MD 21244 Phone: 410 786-6126 FAX: 410 786-9004E-Mail: [email protected]



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 of2005. The rule finalizes portions of the interim final rule published on December 4, 2007, that were not rescinded under theCongressional moratoria. The rule clarifies what is reimbursable under the Medicaid case management and targeted casemanagement benefit and is intended to offer guidance to States on implementing the DRA provisions.

Priority: Economically Significant Agenda Stage of Rulemaking: Completed ActionMajor: Yes Unfunded Mandates: NoCFR 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 6052Legal Deadline: Public Law 110-28 established a 1-year moratorium on rule until May 25, 2008. Public Law 110-252 extendedthe moratorium to March 31, 2009. Public Law 111-5 extended moratorium to June 30, 2009.


Timetable: Action Date FR Cite Interim Final Rule 12/04/2007 72 FR 68077 Interim Final Rule Comment Period End 02/04/2008 Interim Final Rule Effective 03/03/2008 Withdrawn 10/24/2011

Regulatory Flexibility Analysis Required: Undetermined Government Levels Affected: NoSmall Entities Affected: Governmental Jurisdictions Federalism: No

136





Energy Affected: NoAgency Contact: Jean Close Health Insurance SpecialistDepartment of Health and Human ServicesCenters for Medicare & Medicaid ServicesMail Stop S2-14-26 7500 Security BoulevardBaltimore , MD 21244 Phone: 410 786-2804 E-Mail: [email protected]



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 forPrescription Drug Programs (NCPDP) SCRIPT 10.6 for conducting certain e-prescribing transactions for the Medicare Part Delectronic prescription drug program under section 1860D 4(e) of the Social Security Act. As recommended by industrystakeholders, this proposed rule would request comment on adopting newer versions of the eRx standard for use in e-prescribing 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 ActionMajor: No Unfunded Mandates: NoCFR Citation: 42 CFR 423 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: 42 USC 1395Legal Deadline: None

Timetable: Action Date FR Cite Interim Final Rule 07/01/2010 75 FR 38026 Interim Final Rule Comment Period End 08/30/2010 Merged With 0938-AR11 10/24/2011

Regulatory Flexibility Analysis Required: No Government Levels Affected: NoSmall Entities Affected: No Federalism: NoEnergy Affected: NoAgency Contact: Andrew Morgan Health Insurance SpecialistDepartment of Health and Human ServicesCenters for Medicare & Medicaid ServicesOffice of E- Standards & Services Mail Stop, S2-26-17 7500 Security BoulevardBaltimore , MD 21244 Phone: 410 786-2543 FAX: 410-786-1847E-Mail: [email protected]



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 excludingcertain services will be necessary. Section 154 also requires the program to provide a process for giving suppliers feedback onmissing financial documents and mandates the disclosure of subcontractors under a competitive bidding program.

137





Priority: Other Significant Agenda Stage of Rulemaking: Completed ActionMajor: No Unfunded Mandates: NoCFR 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 Source Description Date Other Statutory MMA section 902 01/16/2012

Timetable: Action Date FR Cite Interim Final Rule 01/16/2009 74 FR 2873 Interim Final Rule Comment Period End 03/17/2009 Merged With 0938-AQ27 07/07/2011

Regulatory Flexibility Analysis Required: No Government Levels Affected: NoFederalism: NoAgency Contact: Lorrie Ballantine Technical AdvisorDepartment of Health and Human ServicesCenters for Medicare & Medicaid ServicesMail Stop C5-08-17 7500 Security BoulevardBaltimore , MD 21244 Phone: 410 786-4499 E-Mail: [email protected]



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 HealthInsurance Program Reauthorization Act (CHIPRA) including a CHIP performance bonus payment system through 2013. Forexample, the rule would define and provide more guidance on the parameters of the new Express Lane Eligibility option forStates including what it means to be an Express Lane agency. It would also define the parameters for the new state option tocover pregnant women in CHIP and provide further guidance regarding the newly required dental benefit package. In addition, itwould codify the definition of individuals who are lawfully residing in the US but who are not citizens who can be enrolled inMedicaid and CHIP. Under section 2102 of the Affordable Care Act, this rule would also make technical corrections to selectedprovisions in CHIPRA and the American Recovery and Reinvestment Act of 2009 (ARRA).

Priority: Economically Significant Agenda Stage of Rulemaking: Completed ActionMajor: Undetermined Unfunded Mandates: UndeterminedCFR 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 2102Legal Deadline: None

Timetable: Action Date FR Cite Merged With 0938-AR04 12/31/2011


Regulatory Flexibility Analysis Required: Undetermined Government Levels Affected: StateFederalism: UndeterminedEnergy Affected: UndeterminedRelated RINs: Related to 0938-AP54Agency Contact: Linda Nablo Health Insurance SpecialistDepartment of Health and Human Services

138





Centers for Medicare & Medicaid Services7500 Security BoulevardBaltimore , MD 21244 Phone: 410 786-5143 E-Mail: [email protected]



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 inFY 2009. A State may qualify for the contingency funds if it projects a funding shortfall for the fiscal year (not counting anyredistributed amounts they may receive) and its average monthly child enrollment exceeds its target average number ofenrollees for the fiscal year. Contingency payments equal a State's projected per capita Federal spending multiplied by theexcess amount. This proposed rule implements provisions of the Children's Health Insurance Program Reauthorization Act of2009.

Priority: Other Significant Agenda Stage of Rulemaking: Completed ActionMajor: Undetermined Unfunded Mandates: UndeterminedCFR 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


Regulatory Flexibility Analysis Required: Undetermined Government Levels Affected: StateFederalism: UndeterminedEnergy Affected: NoAgency Contact: Richard Strauss Health Insurance SpecialistDepartment of Health and Human ServicesCenters for Medicare & Medicaid ServicesMail Stop S3-13-15 7500 Security BoulevardBaltimore , MD 21244 Phone: 410 786-2019 E-Mail: [email protected]



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 PaymentSystem 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 patientsin advance of the date of the procedure. Those ASCs who routinely perform same-day procedures will be unable to provide thisinformation prior to the date of surgery and will be out of compliance with the regulation. Therefore, patients will be deniedsame-day procedures in an ASC because of current regulatory requirements.

Priority: Other Significant Agenda Stage of Rulemaking: Completed ActionMajor: No Unfunded Mandates: NoCFR 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)

139






Legal Deadline: Action Source Description Date Other Statutory MMA sec 902 04/23/2010



Regulatory Flexibility Analysis Required: No Government Levels Affected: NoSmall Entities Affected: Business Federalism: NoEnergy Affected: NoAgency Contact: Joan Moliki Health Insurance SpecialistDepartment of Health and Human ServicesCenters for Medicare & Medicaid ServicesMail Stop S3-02-01 7500 Security BoulevardBaltimore , MD 21244 Phone: 410 786-5526 E-Mail: [email protected]



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 theadministration 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 aninterim basis until a final notice or new regulation is issued that revises the maximum regional charges.

Priority: Other Significant Agenda Stage of Rulemaking: Completed ActionMajor: No Unfunded Mandates: NoCFR 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 Date FR Cite Merged With 0938-AQ63 12/01/2011

Regulatory Flexibility Analysis Required: No Government Levels Affected: StateSmall Entities Affected: No Federalism: NoEnergy Affected: NoAgency Contact: Mary Beth Hance Senior Policy AdvisorDepartment of Health and Human ServicesCenters for Medicare & Medicaid ServicesMail Stop S2-26-12 7500 Security BoulevardBaltimore , MD 21224 Phone: 410 786-4299 E-Mail: [email protected]

Department of Health and Human Services (HHS) 140




Centers for Medicare & Medicaid Services ( CMS ) RIN: 0938-AP99


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 inorder to ensure compliance with the statutory requirements governing what is considered a health care related tax.

Priority: Other Significant Agenda Stage of Rulemaking: Completed ActionMajor: No Unfunded Mandates: NoCFR 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


Regulatory Flexibility Analysis Required: No Government Levels Affected: StateSmall Entities Affected: No Federalism: NoEnergy Affected: NoAgency Contact: Kristin Fan Deputy Director, Financial Management GroupDepartment of Health and Human ServicesCenters for Medicare & Medicaid ServicesMail Stop S3-13-23 7500 Security BoulevardBaltimore , MD 21244 Phone: 410 786-4581 E-Mail: [email protected]



Title: Changes Affecting Hospital and Critical Access Hospital (CAH) Conditions of Participation (CoPs): Credentialing andPrivileging 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). Theserevisions allow for a new credentialing and privileging process for physicians and practitioners providing telemedicine services.

Priority: Other Significant Agenda Stage of Rulemaking: Completed ActionMajor: No Unfunded Mandates: NoCFR 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 1395rrLegal Deadline: None



Regulatory Flexibility Analysis Required: No Government Levels Affected: NoSmall Entities Affected: Business Federalism: NoAgency Contact: CDR Scott Cooper Health Insurance SpecialistDepartment of Health and Human ServicesCenters for Medicare & Medicaid Services

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Clinical Standards Group Mail Stop S3-05-15 7500 Security BoulevardBaltimore , MD 21244 Phone: 410 786-9465 E-Mail: [email protected] Contact: Jeannie Miller Director, Clinical Standards Group,Department of Health and Human ServicesCenters for Medicare & Medicaid ServicesMail Stop S3-05-15 7500 Security BoulevardBaltimore , MD 21244 Phone: 410 786-3164 E-Mail: [email protected]



Title: Long-Term Care Facility Quality Assessment and Performance Improvement Dementia Management and AbusePrevention Training (CMS-3231-P)Abstract: This proposed rule would implement section 6102 of the Affordable Care Act by amending the requirements that aninstitution must meet to participate as a skilled nursing facility (SNF) in the Medicare program, or a nursing facility (NF) in theMedicaid program. This proposed rule would require these long term care (LTC) facilities to develop, implement, and maintain aquality assessment and performance improvement (QAPI) program. In addition, this proposed rule would also amend therequirements that an institution must meet in order to qualify to participate as a SNF in the Medicare program, or as a NF in theMedicaid program, by requiring the current mandatory on-going training requirements for nurse aides (NA) to include dementiamanagement and resident abuse training. This proposed rule would also clarify that the definition of NA includes an individualwho provides services through an agency or under contract with a SNF or NF. Finally, this proposed rule would address section6121 of the Affordable Care Act which requires facilities to include dementia management and abuse prevention training as partof pre-employment initial training for permanent and contract or agency staff, and if the Secretary determines appropriate, aspart of ongoing in-service training.

Priority: Other Significant Agenda Stage of Rulemaking: Completed ActionMajor: No Unfunded Mandates: NoCFR 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-7jLegal Deadline: None


Regulatory Flexibility Analysis Required: No Government Levels Affected: NoSmall Entities Affected: Business Federalism: NoEnergy Affected: NoAgency Contact: Kadie Thomas Health Insurance SpecialistDepartment of Health and Human ServicesCenters for Medicare & Medicaid ServicesOffice of Clinical Standards and Quality Mail Stop S3-02-01 7500 Security BoulevardBaltimore , MD 21244 Phone: 410 786-0468 E-Mail: [email protected] Contact: Diane Corning Health Insurance SpecialistDepartment of Health and Human ServicesCenters for Medicare & Medicaid ServicesOffice of Clinical Standards and Quality Mail Stop S3-02-01 7500 Security BoulevardBaltimore , MD 21244 Phone: 410 786-8486 E-Mail: [email protected]

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Title: Administrative Simplification: Adoption of Authoring Organizations for Operating Rules and Adoption of Operating Rulesfor Eligibility and Claims Status (CMS-0032-F)Abstract: This rule implements provisions of the Affordable Care Act of 2010 under Administrative Simplification that requirethe 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.

Priority: Economically Significant Agenda Stage of Rulemaking: Completed ActionMajor: Yes Unfunded Mandates: Private SectorCFR 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 1104Legal Deadline:


Timetable: Action Date FR Cite Interim Final Rule 07/08/2011 76 FR 40458 Interim Final Rule Comment Period End 09/06/2011 Withdrawn 10/24/2011

Regulatory Flexibility Analysis Required: Undetermined Government Levels Affected: FederalSmall Entities Affected: Organizations Federalism: NoEnergy Affected: NoAgency Contact: Lorraine Doo Deputy Director, Office of E-Health Systems and ServicesDepartment of Health and Human ServicesCenters for Medicare & Medicaid ServicesMail Stop S2-26-17 7500 Security BoulevardBaltimore , MD 21244 Phone: 410 786-6597 E-Mail: [email protected]



Title: Inpatient Hospital Deductible and Hospital and Extended Care Services Coinsurance Amounts for CY 2012 (CMS-8043-N)Abstract: This notice announces the inpatient hospital deductible and the hospital and extended care services coinsuranceamounts for services furnished in calendar year 2012 under Medicare's Hospital Insurance program (Medicare Part A). TheMedicare statute specifies the formulae used to determine these amounts.

Priority: Economically Significant Agenda Stage of Rulemaking: Completed ActionMajor: Yes Unfunded Mandates: NoCFR 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:143






Action Date FR Cite Final Action 11/01/2011 76 FR 67568

Regulatory Flexibility Analysis Required: No Government Levels Affected: NoSmall Entities Affected: No Federalism: NoEnergy Affected: NoAgency Contact: Clare McFarland Deputy Director, Medicare and Medicaid Cost Estimates GroupDepartment of Health and Human ServicesCenters for Medicare & Medicaid ServicesOffice of the Actuary Mail Stop N3-26-00 7500 Security BoulevardBaltimore , MD 21244 Phone: 410 786-6390 E-Mail: [email protected]



Title: Part A Premiums for CY 2012 for the Uninsured Aged and for Certain Disabled Individuals Who Have Exhausted OtherEntitlement (CMS-8044-N)Abstract: This notice announces the premium for calendar year 2012 under Medicare's Hospital Insurance program (MedicarePart A) for the uninsured aged and for certain disabled individuals who have exhausted other entitlement.

Priority: Other Significant Agenda Stage of Rulemaking: Completed ActionMajor: No Unfunded Mandates: NoCFR 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, sec1818A(d)(2)Legal Deadline:


Timetable: Action Date FR Cite Final Action 11/01/2011 76 FR 67570

Regulatory Flexibility Analysis Required: No Government Levels Affected: NoSmall Entities Affected: No Federalism: NoEnergy Affected: NoAgency Contact: Clare McFarland Deputy Director, Medicare and Medicaid Cost Estimates GroupDepartment of Health and Human ServicesCenters for Medicare & Medicaid ServicesOffice of the Actuary 7500 Security Boulevard Mail Stop N3-26-00Baltimore , MD 21244 Phone: 410 786-6390 E-Mail: [email protected]



Title: Part B Monthly Actuarial Rates, Monthly Premium Rates, and Annual Deductible Beginning January 1, 2012 (CMS-8045-N)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 ActionMajor: Yes Unfunded Mandates: NoCFR 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 5111Legal Deadline:



Regulatory Flexibility Analysis Required: No Government Levels Affected: NoSmall Entities Affected: No Federalism: NoEnergy Affected: NoAgency Contact: Suzanne Codespote Deputy Director, Medicare and Medicaid Cost Estimates GroupDepartment of Health and Human ServicesCenters for Medicare & Medicaid ServicesOffice of the Actuary 7500 Security Boulevard Mail Stop N3-26-00Baltimore , 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 Medicareclaims data to measure the performance of providers and suppliers in ways that protect patient privacy and in accordance withother requirements.

Priority: Other Significant Agenda Stage of Rulemaking: Completed ActionMajor: No Unfunded Mandates: NoCFR Citation: None (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: PL 111-148, sec 10332Legal Deadline:



Regulatory Flexibility Analysis Required: No Government Levels Affected: NoSmall Entities Affected: Business Federalism: NoEnergy Affected: NoAgency Contact: Colleen Bruce Health Insurance SpecialistDepartment of Health and Human ServicesCenters for Medicare & Medicaid Services7500 Security Boulevard Mail Stop, C5-19-16Baltimore , MD 21244

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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 andmaintenance costs of Medicaid Recovery Audit Contractors (Medicaid RACs), and the payment methodology for State paymentsto Medicaid RACs in accordance with section 6411 of the Affordable Care Act. In addition, this rule includes requirements forStates to assure that adequate appeals processes are in place for providers to dispute adverse determinations made byMedicaid RACs. Finally, the rule requires States and Medicaid RACs coordinate efforts with existing contractors and entitiesauditing Medicaid providers and with State and Federal law enforcement agencies.

Priority: Economically Significant Agenda Stage of Rulemaking: Completed ActionMajor: Yes Unfunded Mandates: NoCFR Citation: 42 CFR 455 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: PL 111-148, sec 6411; PL 111-152Legal Deadline:



Regulatory Flexibility Analysis Required: No Government Levels Affected: StateSmall Entities Affected: Business; Governmental Jurisdictions Federalism: YesEnergy Affected: NoAgency Contact: Joanne Davis Health Insurance SpecialistDepartment of Health and Human ServicesCenters for Medicare & Medicaid ServicesMail Stop B2-15-24 7500 Security BoulevardBaltimore , MD 21244 Phone: 410 786-5127 FAX: 410 786-0711E-Mail: [email protected]



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 amendedby the Affordable Care Act. It would establish a face-to-face encounter as a condition of payment for certain durable medicalequipment (DME). When this face-to-face encounter is performed by a physician assistant, a nurse practitioner or a clinicalnurse specialist, a physician must document that the face-to-face has occurred pursuant to the order being written. Thecomplete 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 ActionMajor: Yes Unfunded Mandates: NoCFR 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 6407Legal Deadline:




Regulatory Flexibility Analysis Required: No Government Levels Affected: NoSmall Entities Affected: Business Federalism: NoEnergy Affected: NoAgency Contact: Latesha Walker IIISupervisory Health Insurance SpecialistDepartment of Health and Human ServicesCenters for Medicare & Medicaid ServicesOffice of Financial Management Mail Stop C3-07-08 7500 Security BoulevardBaltimore , MD 21244 Phone: 410 786-1101 E-Mail: [email protected]



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 servicesand suppliers participating in Accountable Care Organizations (ACOs). Under this provision, providers of services and supplierscan continue to receive traditional Medicare fee-for-service payments under Parts A and B, and be eligible for additionalpayments based on meeting specified quality and savings requirements.

Priority: Economically Significant Agenda Stage of Rulemaking: Completed ActionMajor: Yes Unfunded Mandates: NoCFR Citation: 42 CFR 425 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: PL 111-148, sec 3022Legal Deadline:


Timetable: Action Date FR Cite Notice 11/17/2010 75 FR 70165 NPRM 04/07/2011 76 FR 19527 NPRM Comment Period End 06/06/2011 Final Action 11/02/2011 76 FR 67802

Regulatory Flexibility Analysis Required: No Government Levels Affected: FederalSmall Entities Affected: Organizations Federalism: NoEnergy Affected: NoAgency Contact: Terri Postma Health Insurance SpecialistDepartment of Health and Human ServicesCenters for Medicare & Medicaid ServicesMail Stop C5-01-14 7500 Security BoulevardBaltimore , MD 21244 Phone: 410 786-4169 Extension: 64169

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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 dischargesbeginning July 1, 2011.

Priority: Economically Significant Agenda Stage of Rulemaking: Completed ActionMajor: Yes Unfunded Mandates: NoCFR 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 BBRALegal Deadline:



Regulatory Flexibility Analysis Required: No Government Levels Affected: LocalSmall Entities Affected: Business Federalism: NoAgency Contact: Janet Samen Director, Division of Chronic Care ManagementDepartment of Health and Human ServicesCenters for Medicare & Medicaid ServicesMail Stop C5-05-27 7500 Security BoulevardBaltimore , MD 21244 Phone: 410 786-4533 E-Mail: [email protected]



Title: Proposed Changes to the Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and FY 2012 Ratesand 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 foroperating and capital-related costs. This rule implements changes arising from our continuing experience with these systems.

Priority: Economically Significant Agenda Stage of Rulemaking: Completed ActionMajor: Yes Unfunded Mandates: NoCFR 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, 3025Legal Deadline:

Action Source Description Date NPRM Statutory 04/01/2011 Other Statutory 08/01/2011

Timetable: Action Date FR Cite

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NPRM 05/05/2011 76 FR 25788 NPRM Comment Period End 06/20/2011 Final Action 08/18/2011 76 FR 51476


Regulatory Flexibility Analysis Required: Business Government Levels Affected: NoFederalism: NoEnergy Affected: NoAgency Contact: Ankit Patel Health Insurance Specialist, Division of Acute CareDepartment of Health and Human ServicesCenters for Medicare & Medicaid ServicesHospital and Ambulatory Policy Group Mail Stop, C4-25-11 7500 Security BoulevardBaltimore , MD 21244 Phone: 410 786-4537 E-Mail: [email protected]



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 topayment under Part B. These changes are be applicable to services furnished on or after January 1.

Priority: Economically Significant Agenda Stage of Rulemaking: Completed ActionMajor: Yes Unfunded Mandates: NoCFR Citation: 42 CFR 410; 42 CFR 414; 42 CFR 415; 42 CFR 495 (To search for a specific CFR, visit the Code of FederalRegulations ) Legal Authority: Social Security Act, sec 1102; Social Security Act, sec 1871; PL 111-148Legal Deadline: The statute requires that the final rule be issued by November.


Timetable: Action Date FR Cite NPRM 07/19/2011 76 FR 42772 NPRM Comment Period End 08/30/2011 Final Action 11/28/2011 76 FR 73026 Final Action Effective 01/01/2012


Regulatory Flexibility Analysis Required: Business;Organizations Government Levels Affected: Federal

Federalism: NoEnergy Affected: NoAgency Contact: Christina Ritter Director, Division of Practitioner ServicesDepartment of Health and Human ServicesCenters for Medicare & Medicaid ServicesMail Stop C4-03-06 7500 Security BoulevardBaltimore , MD 21244 Phone: 410 786-4636 E-Mail: [email protected] gov

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Title: Changes to the Hospital Outpatient Prospective Payment System and Ambulatory Surgical Center Payment System forCY 2012 (CMS-1525-F)Abstract: This rule revises the Medicare hospital outpatient prospective payment system to implement applicable statutoryrequirements and changes arising from our continuing experience with this system. The proposed rule also describes changesto the amounts and factors used to determine payment rates for services. In addition, the rule finalizes changes to theAmbulatory Surgical Center Payment System list of services and rates.

Priority: Economically Significant Agenda Stage of Rulemaking: Completed ActionMajor: Yes Unfunded Mandates: NoCFR 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 6001Legal Deadline:




Regulatory Flexibility Analysis Required: Business Government Levels Affected: FederalFederalism: NoEnergy Affected: NoAgency Contact: Paula Smith Health Insurance SpecialistDepartment of Health and Human ServicesCenters for Medicare & Medicaid ServicesMail Stop, C4-05-13 7500 Security BoulevardBaltimore , MD 21244 Phone: 410 786-4709 E-Mail: [email protected]



Title: End-Stage Renal Disease Prospective Payment System for CY 2012, Quality Incentive Program for PY 2013 and PY2014; 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 revisesthe ambulance fee schedule regulations to conform with statutory changes. Finally, this rule revises the definition of durablemedical equipment (DME) by adding a 3-year minimum lifetime criterion that must be met by an item or device in order to beconsidered durable for the purpose of classifying the item under the Medicare benefit category for DME.

Priority: Economically Significant Agenda Stage of Rulemaking: Completed ActionMajor: Yes Unfunded Mandates: NoCFR 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), MMEALegal Deadline:


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Other Statutory 11/01/2011


Regulatory Flexibility Analysis Required: No Government Levels Affected: FederalSmall Entities Affected: Business Federalism: NoEnergy Affected: NoAgency Contact: Janet Samen Director, Division of Chronic Care ManagementDepartment of Health and Human ServicesCenters for Medicare & Medicaid ServicesMail Stop C5-05-27 7500 Security BoulevardBaltimore , MD 21244 Phone: 410 786-4533 E-Mail: [email protected]



Title: Prospective Payment System for Inpatient Rehabilitation Facilities for FY 2012; Changes in Size of InpatientRehabilitation 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 reportingprogram that provides for a reduction in the annual increase factor beginning in 2014 for failure to report quality data to theSecretary of Health and Human Services. This rule also updates the prospective payment rates for inpatient rehabilitationfacilities (IRFs) for Federal fiscal year 2012 (for discharges occurring on or after October 1, 2011 and on or before September30, 2012) as required under section 1886(j)(3)(C) of the Social Security Act (the Act). Section 1886(j)(5) of the Act requires theSecretary to publish in the Federal Register on or before the August 1 that precedes the start of each FY the classification andweighting factors for the IRF prospective payment system (PPS) case-mix groups and a description of the methodology anddata used in computing the prospective payment rates for that fiscal year. We are also consolidating, clarifying, and revisingexisting policies regarding IRF hospitals and IRF units of hospitals to eliminate unnecessary confusion and enhanceconsistency. Furthermore, in accordance with the general principles of the President's January 18, 2011 Executive Orderentitled "Improving Regulation and Regulatory Review," we are amending existing regulatory provisions regarding "new" facilitiesand changes in the bed size and square footage of IRFs and inpatient psychiatric facilities (IPFs) to improve clarity and removeobsolete material.

Priority: Economically Significant Agenda Stage of Rulemaking: Completed ActionMajor: Yes Unfunded Mandates: NoCFR 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 3004Legal Deadline:




Regulatory Flexibility Analysis Required: No Government Levels Affected: FederalSmall Entities Affected: Business Federalism: NoEnergy Affected: No

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Agency Contact: Gwendolyn Johnson Health Insurance SpecialistDepartment of Health and Human ServicesCenters for Medicare & Medicaid ServicesCenter for Medicare Management Mail Stop C5-06-27 7500 Security BoulevardBaltimore , MD 21244 Phone: 410 786-6954 E-Mail: [email protected]



Title: Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities for FY 2012; Required Disclosures ofOwnership (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 ofthe Resource Utilization Groups, version 4 (RUG-IV) case-mix classification system, discusses how such changes may affectthe objective of maintaining parity in overall expenditures between RUG-IV and the previous case-mix classification system, andconsiders a possible recalibration of the case-mix indexes so that they more accurately reflect parity in expenditures. It alsoincludes a discussion of a Non-Therapy Ancillary component and outlier research currently under development within CMS. Inaddition, this rule discusses the impact of certain provisions of the Affordable Care Act , and new programs and initiativesaffecting SNFs. It also implements section 3401(b) of the Affordable Care Act, which requires for fiscal year 2012 andsubsequent fiscal years that the SNF market basket percentage change be reduced by the multi-factor productivity adjustmentdescribed in section 1886(b)(3)(B)(xi)(II) of the Act. It also implements section 6101 of the Affordable Care Act, which requiresMedicare SNFs and Medicaid nursing facilities to disclose certain information to the Secretary and other entities regarding theownership and organizational structure of their facilities.

Priority: Economically Significant Agenda Stage of Rulemaking: Completed ActionMajor: Yes Unfunded Mandates: NoCFR 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 6101Legal Deadline:



Regulatory Flexibility Analysis Required: Business Government Levels Affected: FederalFederalism: NoEnergy Affected: NoAgency Contact: William Ullman Technical AdvisorDepartment of Health and Human ServicesCenters for Medicare & Medicaid ServicesCenters for Medicare Management Mail Stop C5-06-27 7500 Security BoulevardBaltimore , MD 21244 Phone: 410 786-5667 FAX: 410 786-0765E-Mail: [email protected]


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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 andcase-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. Thesechanges are applicable to services furnished on or after January 1st.

Priority: Economically Significant Agenda Stage of Rulemaking: Completed ActionMajor: Yes Unfunded Mandates: NoCFR 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 USC1395(fff), PL 111-148 secs 3131, 3401, 6407Legal Deadline:




Regulatory Flexibility Analysis Required: Business Government Levels Affected: FederalFederalism: NoEnergy Affected: NoAgency Contact: Kelly Horney Health Insurance Specialist,Department of Health and Human ServicesCenters for Medicare & Medicaid ServicesCenter for Medicare Management Mail Stop C5-07-28 7500 Security BoulevardBaltimore , MD 21244 Phone: 410 786-0558 FAX: 410 786-0765E-Mail: [email protected]



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. Theupdate takes effect October 1.

Priority: Other Significant Agenda Stage of Rulemaking: Completed ActionMajor: No Unfunded Mandates: NoCFR 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 3004Legal Deadline:



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Final Action 08/04/2011 76 FR 47302


Regulatory Flexibility Analysis Required: No Government Levels Affected: FederalSmall Entities Affected: Business Federalism: NoEnergy Affected: NoAgency Contact: Katherine Lucas Health Insurance SpecialistDepartment of Health and Human ServicesCenters for Medicare & Medicaid ServicesMail Stop C5-08-23 7500 Security BoulevardBaltimore , MD 21244 Phone: 410 786-7723 E-Mail: [email protected]



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 careacquired conditions.

Priority: Other Significant Agenda Stage of Rulemaking: Completed ActionMajor: No Unfunded Mandates: NoCFR 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 2702Legal Deadline:



Regulatory Flexibility Analysis Required: No Government Levels Affected: StateFederalism: NoEnergy Affected: NoAgency Contact: Venesa Day Health Insurance SpecialistDepartment of Health and Human ServicesCenters for Medicare & Medicaid ServicesCenter for Medicaid and State Operations Mail Stop S3-13-15 7500 Security BoulevardBaltimore , MD 21244 Phone: 410 786-8281 E-Mail: [email protected]



Title: Medicaid Automated Data System Requirements and Data Elements Necessary for Program Integrity, ProgramOversight, 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 theprovision that requires States, for data submitted on or after January 1, 2010, to include data elements from the automated datasystem that CMS determines to be necessary for program integrity, program oversight, and administration, at such frequency asCMS shall determine. It also would implement the provision that requires for managed care patients that the managed careplans provide data to States at a frequency and level of detail as specified by CMS. In addition, the rule would implement theprovision that provides for withholding of Federal Matching Payments to States that fail to report enrollee encounter data in theMedicaid Statistical Information System.

Priority: Other Significant Agenda Stage of Rulemaking: Completed ActionMajor: No Unfunded Mandates: NoCFR 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; PL111-148, sec 6505; ...Legal Deadline:



Regulatory Flexibility Analysis Required: No Government Levels Affected: TribalFederalism: NoEnergy Affected: NoAgency Contact: Karen Raschke Deputy Director, Data and Systems GroupDepartment of Health and Human ServicesCenters for Medicare & Medicaid Services7500 Security BoulevardBaltimore , MD 21244 Phone: 410 786-0016 E-Mail: [email protected]



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 grouphealth insurance markets and non-federal governmental plans, made by the Mental Health Parity and Addiction Equity Act of2008 (MHPAEA).

Priority: Economically Significant Agenda Stage of Rulemaking: Completed ActionMajor: Undetermined Unfunded Mandates: NoCFR Citation: 45 CFR 136 and 146 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: PL 110-343Legal Deadline: None

Timetable: Action Date FR Cite Request for Information 04/28/2009 74 FR 19155 Request for Information Comment Period Ended 05/28/2009 Interim Final Rule 02/02/2010 75 FR 5410 Interim Final Rule Comment Period End 05/03/2010 Withdrawn 11/17/2011


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Related RINs: Related to 0938-AP65 Related Agencies: Joint: EBSA; Joint: IRSAgency Contact: James Mayhew Health Insurance SpecialistDepartment of Health and Human ServicesCenters for Medicare & Medicaid Services7500 Security BoulevardBaltimore , MD 21244 Phone: 301 492-4113 E-Mail: [email protected]



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 theState health subsidy programs known as "the Exchange". The Affordable Care Act requires many changes to State eligibility andenrollment 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 Statesabout the higher rates that CMS will provide to help them update or build legacy eligibility systems that meet the ACArequirements.

Priority: Economically Significant Agenda Stage of Rulemaking: Completed ActionMajor: Yes Unfunded Mandates: NoCFR Citation: 42 CFR 433 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: PL 111-148, sec 1413Legal Deadline: None


Regulatory Flexibility Analysis Required: GovernmentalJurisdictions Government Levels Affected: State

Federalism: YesEnergy Affected: NoAgency Contact: Richard H. Friedman Director, Division of State SystemsDepartment of Health and Human ServicesCenters for Medicare & Medicaid ServicesMail Stop S3-18-13 7500 Security BoulevardBaltimore , MD 21244 Phone: 410 786-4451 E-Mail: [email protected]



Title: Medicaid Program; Federal Medical Assistance Percentages (FMAP) for Newly Eligible Mandatory Individuals andExpansion States (CMS-2327-P)Abstract: This proposed rule sets forth methodologies for FMAP calculations. And the related conditions and requirements thatwill be available for State medical assistance expenditures relating to "newly eligible" individuals and certain medical assistanceexpenditures in "Expansion States" beginning January 1, 2014, under the Affordable Care Act of 2010 . This proposed rule alsosets 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 ActionMajor: No Unfunded Mandates: NoCFR Citation: 42 CFR 433 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: PL 111-148, sec 2001Legal Deadline:



Regulatory Flexibility Analysis Required: No Government Levels Affected: StateSmall Entities Affected: No Federalism: YesEnergy Affected: NoAgency Contact: Diane Gerrits Senior Policy AdvisorDepartment of Health and Human ServicesCenters for Medicare & Medicaid ServicesMail Stop S3-14-23 7500 Security BoulevardBaltimore , MD 21244 Phone: 410 786-5776 E-Mail: [email protected]



Title: Revisions to Medicare Advantage and Part D Prescription Drug Programs; MIPPA-Related Marketing Revisions andAgent/Broker Compensation Plan (CMS-4138-F)Abstract: This rule finalizes several Medicare Advantage and Part D prescription drug program provisions specified in MIPPAalong 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 themarketing of Part C and D plans; cost-sharing for dual eligible enrollees; and Part D prescription drug program pricing,coverage, and payment processes.

Priority: Economically Significant Agenda Stage of Rulemaking: Completed ActionMajor: Yes Unfunded Mandates: NoCFR 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 1395hhLegal Deadline:

Action Source Description Date Other Statutory MMA Section 902 09/18/2011


Regulatory Flexibility Analysis Required: No Government Levels Affected: FederalSmall Entities Affected: Business Federalism: NoEnergy Affected: NoRelated RINs: Related to 0938-AP52Agency Contact: Vanessa Duran Supervisory Health Insurance SpecialistDepartment of Health and Human ServicesCenters for Medicare & Medicaid Services

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Division of Policy, Analysis and Planning 7500 Security Boulevard Mail Stop C4-21-26Baltimore , MD 21244 Phone: 410 786-8697 E-Mail: [email protected]



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 ofa health care provider to register with the State and the Secretary in a form and manner specified by the Secretary.

Priority: Other Significant Agenda Stage of Rulemaking: Completed ActionMajor: Undetermined Unfunded Mandates: UndeterminedCFR 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 6503Legal Deadline: None


Regulatory Flexibility Analysis Required: Undetermined Government Levels Affected: StateFederalism: NoEnergy Affected: UndeterminedAgency Contact: Richard Friedman Director, Division of State SystemsDepartment of Health and Human ServicesCenters for Medicare & Medicaid ServicesMail Stop S3-18-13 7500 Security BoulevardBaltimore , MD 21244 Phone: 410 786-4451 E-Mail: [email protected]



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, andincludes specific data and their application (or not) to the Trade Secrets Act. This rule would clarify statutory requirements underthe Affordable Care Act.

Priority: Other Significant Agenda Stage of Rulemaking: Completed ActionMajor: No Unfunded Mandates: NoCFR Citation: 45 CFR 159 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: PL 111-148Legal Deadline: None



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Energy Affected: NoAgency Contact: Elizabeth Hadley Health Insurance SpecialistDepartment of Health and Human ServicesCenters for Medicare & Medicaid Services7500 Security BoulevardBaltimore , MD 21244 Phone: 301 492-4222 E-Mail: [email protected]



Title: Medical Loss Ratios (CMS-9998-FC)Abstract: The Affordable Care Act requires health insurance issuers offering individual or group coverage to submit annualreports to the Secretary on the percentages of premiums that the coverage spends on reimbursement for clinical services andactivities that improve health care quality, and to provide rebates to enrollees if this spending does not meet minimum standardsfor a given plan year. This final rule implements the definition and methodology associated with the calculation of the MedicalLoss Ratio (MLR) provisions of the Affordable Care Act and the calculation of the rebate to consumers for plans that do notsatisfy the MLR.

Priority: Other Significant Agenda Stage of Rulemaking: Completed ActionMajor: No Unfunded Mandates: NoCFR Citation: 45 CFR 158 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: PL 111-148Legal Deadline:


Timetable: Action Date FR Cite Interim Final Rule 12/01/2010 75 FR 74864 Interim Final Rule Effective 01/01/2011 Interim Final Rule Comment Period End 01/31/2011 Final Action 12/07/2011 76 FR 76574

Regulatory Flexibility Analysis Required: No Government Levels Affected: StateFederalism: NoEnergy Affected: NoAgency Contact: James Mayhew Health Insurance SpecialistDepartment of Health and Human ServicesCenters for Medicare & Medicaid Services7500 Security BoulevardBaltimore , MD 21244 Phone: 301 492-4113 E-Mail: [email protected]



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 complexmedical review.

159





Priority: Other Significant Agenda Stage of Rulemaking: Completed ActionMajor: No Unfunded Mandates: NoCFR Citation: 42 CFR 421 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: PL 111-152, sec 1302Legal Deadline: None

Timetable: Action Date FR Cite Merged With 0938-AR11 12/31/2011

Regulatory Flexibility Analysis Required: No Government Levels Affected: NoSmall Entities Affected: Business Federalism: NoRelated RINs: Related to 0938-AN31Agency Contact: Debbie Skinner Health Insurance SpecialistDepartment of Health and Human ServicesCenters for Medicare & Medicaid Services7500 Security BoulevardBaltimore , MD 21244 Phone: 410 786-7480 E-Mail: [email protected]



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 forphysicians' services. The Act requires that we review RVUs no less than every five years. The revised values will be finalized inthe 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 ActionMajor: No Unfunded Mandates: NoCFR 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 proposedrule comment period.


Timetable: Action Date FR Cite Notice 06/06/2011 76 FR 32410 Merged With 0938-AQ25 07/07/2011

Regulatory Flexibility Analysis Required: Business Government Levels Affected: FederalFederalism: NoEnergy Affected: NoAgency Contact: Rebecca Cole Health Insurance SpecialistDepartment of Health and Human ServicesCenters for Medicare & Medicaid ServicesMail Stop: C4-03-06 7500 Security BoulevardBaltimore , MD 21244 Phone: 410 786-1589 E-Mail: [email protected]

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Title: Changes to the End-Stage Renal Disease Prospective Payment System Transition Budget-Neutrality Adjustment (CMS-1435-IFC)Abstract: This interim final rule with comment will revise the end-stage renal disease (ESRD) transition budget-neutralityadjustment 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 ActionMajor: No Unfunded Mandates: NoCFR Citation: 42 CFR 413 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: sec 1881 of the Social Security ActLegal Deadline: None

Timetable: Action Date FR Cite Interim Final Rule 04/06/2011 76 FR 18930 Merged With 0938-AQ27 06/07/2011 Interim Final Rule Comment Period End 06/06/2011

Regulatory Flexibility Analysis Required: No Government Levels Affected: NoSmall Entities Affected: Business Federalism: NoAgency Contact: Janet Samen Division Director of Chronic Care ManagementDepartment of Health and Human ServicesCenters for Medicare & Medicaid ServicesCenters for Medicare Management Mail Stop C5-05-27 7500 Security BoulevardBaltimore , MD 21244 Phone: 410 786-9161 E-Mail: [email protected]



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 inthe individual and small group markets. Such qualified nonprofit issuers must operate with a strong consumer focus and use anyprofits to lower premiums, improve benefits, or improve the quality of health care delivered to plan members.

Priority: Economically Significant Agenda Stage of Rulemaking: Completed ActionMajor: Yes Unfunded Mandates: NoCFR Citation: 45 CFR 170 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: PL 111-148, sec 1322Legal Deadline:

Action Source Description Date Other Statutory Grants and loans must be awarded by 7/1/2013. 07/01/2013


Regulatory Flexibility Analysis Required: No Government Levels Affected: Federal

161






Small Entities Affected: Organizations Federalism: NoRelated RINs: Related to 0938-AQ82Agency Contact: Barbara Smith Associate Director, Consumer Operated and Oriented Plan ProgramDepartment of Health and Human ServicesCenters for Medicare & Medicaid Services7500 Security BoulevardBaltimore , MD 21244 Phone: 301 492-4455 E-Mail: [email protected]



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 forreporting periods in calendar year (CY) 2011) and provides additional significant hardship exemption categories for eligibleprofessionals and group practices to request an exemption during 2011 for the 2012 eRx payment adjustment due to asignificant hardship.

Priority: Other Significant Agenda Stage of Rulemaking: Completed ActionMajor: No Unfunded Mandates: NoCFR Citation: 42 CFR 414 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: MIPPA, sec132Legal Deadline: None


Regulatory Flexibility Analysis Required: No Government Levels Affected: NoSmall Entities Affected: Business Federalism: NoAgency Contact: Aucha Prachanronarong Health Insurance SpecialistDepartment of Health and Human ServicesCenters for Medicare & Medicaid ServicesMailstop S3-02-01 7500 Security BlvdBaltimore , MD 21244 Phone: 410 786-1879 E-Mail: [email protected]



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 testspaid under the Clinical Laboratory Fee Schedule (CLFS) originally established in the CY 2011 Physician Fee Schedule final rulepublished on November 29, 2010.

Priority: Info./Admin./Other Agenda Stage of Rulemaking: Completed ActionMajor: No Unfunded Mandates: NoCFR Citation: 42 CFR 410 (To search for a specific CFR, visit the Code of Federal Regulations )

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Legal Authority: Social Security ActLegal Deadline: None

Timetable: Action Date FR Cite NPRM 06/30/2011 76 FR 38342 Merged With 0938-AQ25 07/22/2011 NPRM Comment Period End 08/29/2011


Regulatory Flexibility Analysis Required: No Government Levels Affected: NoSmall Entities Affected: No Federalism: NoEnergy Affected: NoAgency Contact: Glenn McGuirk Health Insurance SpecialistDepartment of Health and Human ServicesCenters for Medicare & Medicaid ServicesMail Stop C4-01-26 7500 Security BoulevardBaltimore , MD 21244 Phone: 410 786-5723 E-Mail: [email protected]



Title: Exchange Functions in the Individual Market: Eligibility Determinations; Standards for Verification of Employer-SponsoredHealth Coverage, Employer Appeals, and Employer SHOP Participation (CMS-9974-FAbstract: This rule continues to implement the new Affordable Insurance Exchanges (Exchanges), consistent with title I of theAffordable Care Act of 2010. The Exchanges will provide competitive marketplaces for individuals and small employers todirectly 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 choiceof affordable health insurance, and give small businesses the same purchasing clout as large businesses.

Priority: Economically Significant Agenda Stage of Rulemaking: Completed ActionMajor: Yes Unfunded Mandates: NoCFR 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 1413Legal Deadline:


Timetable: Action Date FR Cite NPRM 08/17/2011 76 FR 51202 NPRM Comment Period End 10/31/2011 Merged With 0938-AQ67 12/31/2011

Regulatory Flexibility Analysis Required: Undetermined Government Levels Affected: NoSmall Entities Affected: Business Federalism: NoEnergy Affected: NoAgency Contact: Alissa Deboy Health Insurance Specialist, Center for Consumer Information & Insurance OversightDepartment of Health and Human ServicesCenters for Medicare & Medicaid Services7500 Security BoulevardBaltimore , MD 21244 Phone: 301 492-4428

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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 periodentitled "Rate Increase Disclosure and Review." This final rule addresses the public comments we received and amends thedefinitions of "individual market" and "small group market" to include coverage sold to individuals and small groups throughassociations even if the State excludes the coverage from its definitions of individual and small group market coverage. Thisfinal rule updates requirements for health insurance issuers regarding disclosure and review of unreasonable premium increasesunder section 2794 of the Public Health Service Act.

Priority: Other Significant Agenda Stage of Rulemaking: Completed ActionMajor: No Unfunded Mandates: NoCFR Citation: 45 CFR 154 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: 42 USC 300gg-94Legal Deadline: None


Regulatory Flexibility Analysis Required: No Government Levels Affected: StateSmall Entities Affected: Business Federalism: NoRelated RINs: Related to 0938-AQ68Agency Contact: James Mayhew Health Insurance SpecialistDepartment of Health and Human ServicesCenters for Medicare & Medicaid Services7500 Security BoulevardBaltimore , MD 21244 Phone: 301 492-4113 E-Mail: [email protected]

Department of Health and Human Services (HHS) Office of Public Health and Science ( OPHS ) RIN: 0940-AA01


Title: Public Health Service Standards for the Protection of Research Misconduct WhistleblowersAbstract: To implement section 493(e) of the Public Health Service Act (added by sec. 163 of the National Institutes of HealthRevitalization Act of 1993, Pub. L. 103-43), the Department is proposing to add a new part 94 to title 42 of the Code of FederalRegulations. Under this proposed regulation, covered institutions must follow certain requirements for preventing and respondingto occurrences of retaliation against whistleblowers. The purpose of this part is to protect: 1) Persons who make a good faithallegation that a covered institution or member thereof engaged in, or failed to respond adequately, to an allegation of researchmisconduct; and 2) persons who cooperate in good faith with an investigation of research misconduct.

Priority: Substantive, Nonsignificant Agenda Stage of Rulemaking: Completed ActionMajor: No Unfunded Mandates: NoCFR 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 241Legal Deadline: None


164






NPRM 11/28/2000 65 FR 70830 Transferred to RIN 0937-AA03 08/10/2011

Regulatory Flexibility Analysis Required: No Government Levels Affected: NoSmall Entities Affected: No Federalism: NoRelated RINs: Related to 0940-AA04Agency Contact: John Dahlberg Senior ScientistDepartment of Health and Human ServicesOffice of Public Health and Science1101 Wootton ParkwayRockville , MD 20852 Phone: 301 443-5300 E-Mail: [email protected]

Department of Health and Human Services (HHS) Office for Civil Rights ( OCR ) RIN: 0945-AA00


Title: HIPAA Privacy Rule Accounting of Disclosures under the Health Information Technology for Economic and Clinical HealthActAbstract: The Department of Health and Human Services, Office for Civil Rights, will issue rules to modify the HIPAA PrivacyRule as necessary to implement the accounting of disclosures provisions of Section 13405(c) of the Health InformationTechnology for Economic and Clinical Health Act (Title XIII of the American Recovery and Reinvestment Act of 2009).

Priority: Other Significant Agenda Stage of Rulemaking: Final RuleMajor: No Unfunded Mandates: NoCFR 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 Date FR Cite NPRM 05/31/2011 76 FR 31426 NPRM Comment Period End 08/01/2011 Final Rule 06/00/2012

Regulatory Flexibility Analysis Required: Undetermined Government Levels Affected: UndeterminedFederalism: NoAgency Contact: Andra Wicks Privacy Specialist, Office of Civil RightsDepartment of Health and Human ServicesOffice for Civil Rights200 Independence Avenue SW.Washington , DC 20201 Phone: 202 205-2292 FAX: 202 205-4786E-Mail: [email protected]



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 HIPAAPrivacy, 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 (TitleXIII of the American Recovery and Reinvestment Act of 2009), and will modify the HIPAA Privacy Rule as required by section105 of the Genetic Information Nondiscrimination Act of 2008.

Priority: Economically Significant Agenda Stage of Rulemaking: Final RuleMajor: Undetermined Unfunded Mandates: NoCFR 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-9Legal Deadline:

Action Source Description Date Other Statutory Effective date of certain HITECH enforcement provisions 02/18/2009 Other Statutory Deadline for final GINA rule 05/21/2009 Other Statutory Deadline for Interim Final Rule on Breach Notification 08/17/2009

Other Statutory Effective date of certain HITECH privacy, security, and enforcementprovisions

02/18/2010

Other Statutory Effective date of certain HITECH enforcement provisions 02/18/2011


Regulatory Flexibility Analysis Required: No Government Levels Affected: NoFederalism: NoAgency Contact: Andra Wicks Privacy Specialist, Office of Civil RightsDepartment of Health and Human ServicesOffice for Civil Rights200 Independence Avenue SW.Washington , DC 20201 Phone: 202 205-2292 FAX: 202 205-4786E-Mail: [email protected]



Title: Nondiscrimination Under the Affordable Care ActAbstract: The Department of Health and Human Services, Office for Civil Rights, will issue rules for covered entities withrespect to prohibitions against discrimination on the basis of race, color, national origin, sex, age, and disability, as provided inSection 1557 of the Affordable Care Act. Section 1557 provides certain protections from discrimination by recipients of federalfinancial assistance, federally conducted programs, and entities established under title I of the Affordable Care Act. This sectionalso identifies additional forms of federal financial assistance to which the section will apply.

Priority: Other Significant Agenda Stage of Rulemaking: Long-term ActionMajor: Undetermined Unfunded Mandates: UndeterminedCFR Citation: Not Yet Determined (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: PL 111-148, sec 1557Legal Deadline: None


Regulatory Flexibility Analysis Required: Undetermined Government Levels Affected: UndeterminedFederalism: UndeterminedEnergy Affected: Undetermined

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Agency Contact: Carole Brown Equal Opportunity SpecialistDepartment of Health and Human ServicesOffice for Civil Rights200 Independence Avenue SW.Washington , DC 20201 Phone: 202 619-0805 E-Mail: [email protected]



Title: Individual Access to Protected Health Information Held by CLIA LaboratoriesAbstract: The Department of Health and Human Services, Office for Civil Rights, will modify the HIPAA Privacy Rule toconform the access provisions to be consistent with new Centers for Medicare & Medicaid Services regulations that will providefor laboratories subject to the Clinical Laboratory Improvements Amendments of 1988 to provide individuals with access to theirprotected health information.

Priority: Substantive, Nonsignificant Agenda Stage of Rulemaking: Completed ActionMajor: Undetermined Unfunded Mandates: UndeterminedCFR Citation: 45 CFR 164 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: PL 104-191 sec 264Legal Deadline: None

Timetable: Action Date FR Cite NPRM 09/14/2011 76 FR 56712 NPRM Comment Period End 11/14/2011 Merged With 0938-AQ38 12/30/2011

Regulatory Flexibility Analysis Required: Undetermined Government Levels Affected: UndeterminedFederalism: UndeterminedAgency Contact: Andra Wicks Privacy Specialist, Office of Civil RightsDepartment of Health and Human ServicesOffice for Civil Rights200 Independence Avenue SW.Washington , DC 20201 Phone: 202 205-2292 FAX: 202 205-4786E-Mail: [email protected]

Department of Health and Human Services (HHS) Administration for Children and Families ( ACF ) RIN: 0970-AC42


Title: Implementation of the Unaccompanied Alien Children (UAC) Provisions of the Trafficking Victims Reauthorization Act of2008Abstract: 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 theOffice of Refugee Resettlement (ORR). This rule would implement changes to the program under section 235 of the Actaddressing issues like age determinations, placement determinations, suitability assessments, and home studies. This rule alsowill address provisions of the Flores settlement agreement that were not addressed in Public Law 110-457.

Priority: Other Significant Agenda Stage of Rulemaking: Proposed RuleMajor: No Unfunded Mandates: No

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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 2008Legal Deadline: None


Regulatory Flexibility Analysis Required: No Government Levels Affected: FederalSmall Entities Affected: No Federalism: NoEnergy Affected: NoAgency Contact: Kenneth Tota Chief of Operations--Office of Refugee ResettlementDepartment of Health and Human ServicesAdministration for Children and Families370 L'Enfant Promenade SW.Washington , DC 20447 Phone: 202 401-4858 E-Mail: [email protected]



Title: Performance Standards for Runaway and Homeless Youth GranteesAbstract: This rule would implement section VIII of the Reconnecting Homeless Youth Act of 2008, requiring the Secretary ofHealth and Human Services to issue rules that specify performance standards for public and nonprofit private entities thatreceive grants under the Runaway and Homeless Youth Program.

Priority: Other Significant Agenda Stage of Rulemaking: Proposed RuleMajor: No Unfunded Mandates: NoCFR Citation: 45 CFR 1351 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: Reconnecting Homeless Youth Act, PL 110-378Legal Deadline:

Action Source Description Date Other Statutory Statutory. 10/08/2009


Regulatory Flexibility Analysis Required: No Government Levels Affected: Local; State; TribalSmall Entities Affected: Organizations Federalism: NoEnergy Affected: NoAgency Contact: Curtis O. Porter Division Director, Family & Youth Services Bureau, ACYFDepartment of Health and Human ServicesAdministration for Children and Families370 L'Enfant Promenade SW.Washington , DC 20447 Phone: 202 205-8306 E-Mail: [email protected]


View Related Documents168






Title: Flexibility and Efficiency in Child SupportAbstract: This regulation will propose a variety of changes to child support regulations that will result in more efficient andeffective operations and give state child support agencies additional flexibility. The regulation will propose: (1) Changes toimprove program management, including payment processing and disbursement; (2) updates to account for advances intechnology; and (3) technical corrections.

Priority: Other Significant Agenda Stage of Rulemaking: Proposed RuleMajor: No Unfunded Mandates: NoCFR 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 ActLegal Deadline: None


Regulatory Flexibility Analysis Required: No Government Levels Affected: Federal; Local; StateSmall Entities Affected: No Federalism: NoEnergy Affected: NoAgency Contact: Yvette Riddick Director, Division of Policy, OCSEDepartment of Health and Human ServicesAdministration for Children and Families370 L'Enfant Promenade SW.Washington , DC 20447 Phone: 202 401-4885 E-Mail: [email protected]



Title: Federal Case Registry System of Records ExemptionAbstract: HHS proposes to exempt Federal Case Registry records marked with the Family Violence Indicator from certainrequirements of the Privacy Act to prevent disclosure of records pertaining to victims of domestic violence.

Priority: Other Significant Agenda Stage of Rulemaking: Proposed RuleMajor: No Unfunded Mandates: NoCFR Citation: 45 CFR 5 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: 42 USC 652(a); 42 USC 1302Legal Deadline: None


Regulatory Flexibility Analysis Required: No Government Levels Affected: FederalSmall Entities Affected: No Federalism: NoEnergy Affected: NoAgency Contact: Linda Deimeke Director, Division of Federal Systems, OCSEDepartment of Health and Human ServicesAdministration for Children and Families370 L'Enfant Promenade SW.Washington , DC 20447 Phone: 202 401-5439

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Title: Child Care and Development Fund Reforms to Support Child Development and Working FamiliesAbstract: 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 ofchild care; (3) establishing family-friendly policies; (4) increasing State flexibility through select provisions; and (5) strengtheningprogram integrity. The changes would update the regulations to reflect: current research and knowledge about the early careand education sector; State innovations in policies and practices over the past decade; and increased recognition that highquality child care both supports work for low-income parents and promotes children's learning and healthy development.

Priority: Other Significant Agenda Stage of Rulemaking: Proposed RuleMajor: No Unfunded Mandates: NoCFR 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 amendedLegal Deadline: None


Regulatory Flexibility Analysis Required: No Government Levels Affected: State; TribalSmall Entities Affected: No Federalism: NoEnergy Affected: NoAgency Contact: Andrew Williams Program Specialist, Policy and Planning DivisionDepartment of Health and Human ServicesAdministration for Children and FamiliesOffice of Child Support Enforcement 370 L'Enfant Promenade SW.Washington , DC 20447 Phone: 202 401-1467 FAX: 202 690-5600E-Mail: [email protected]



Title: Tribal Child WelfareAbstract: This rule would implement title III, Tribal Foster Care and Adoption Access, of the Fostering Connections to Successand Increasing Adoptions Act of 2008 (the Act). Under section 301 of the Act, the Secretary is required to promulgate interimfinal regulations to carry out the title III provisions, including providing for transfer of responsibility for the placement and care ofa child under a state plan approved under section 471 of the Social Security Act to a tribal plan. This rule also will address in-kind expenditures from third-party sources for purposes of determining the non-federal share of administrative and trainingexpenditures as required in section 301 of the Act.

Priority: Other Significant Agenda Stage of Rulemaking: Final RuleMajor: No Unfunded Mandates: NoCFR 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 2008Legal Deadline:


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Other Statutory Statutory. 10/09/2009


Regulatory Flexibility Analysis Required: No Government Levels Affected: State; TribalSmall Entities Affected: No Federalism: NoEnergy Affected: NoAgency Contact: Elizabeth Sharp ACYFDepartment of Health and Human ServicesAdministration for Children and Families1250 Maryland Avenue SWWashington , DC 20447 Phone: 202 205-7265 FAX: 202 205-8221E-Mail: [email protected]



Title: Head Start Eligibility DeterminationsAbstract: This regulation amends Head Start Program regulations to clarify and strengthen procedures to determine eligibilityfor Head Start program enrollment, including procedures to document and verify such eligibility. The intent of this rule is toreduce 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 RuleMajor: No Unfunded Mandates: NoCFR Citation: Not Yet Determined (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: 42 USC 9801 et seqLegal Deadline: None


Regulatory Flexibility Analysis Required: No Government Levels Affected: NoSmall Entities Affected: No Federalism: NoEnergy Affected: NoAgency Contact: Colleen Rathgeb Division Director, Policy and Budget, HSDepartment of Health and Human ServicesAdministration for Children and Families1250 Maryland Avenue SW.Washington , DC 20024 Phone: 202 205-7378 E-Mail: [email protected]



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Title: Designation Renewal of Head Start GranteesAbstract: This rule would implement provisions of the Improving Head Start for School Readiness Act of 2007 (Pub. L. 110-134), requiring the Secretary to develop a system that will evaluate each grantee's performance every five years to determinewhich grantees are providing services of such high quality that they should be given another five-year grant without needing torecompete for the grant.

Priority: Other Significant Agenda Stage of Rulemaking: Completed ActionMajor: No Unfunded Mandates: NoCFR 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 110-134Legal Deadline: None


Regulatory Flexibility Analysis Required: No Government Levels Affected: NoSmall Entities Affected: No Federalism: NoEnergy Affected: NoAgency Contact: Colleen Rathgeb Department of Health and Human ServicesAdministration for Children and Families1250 Maryland Avenue SW.Washington , DC 20447 Phone: 202 205-7378 E-Mail: [email protected]



Title: Strengthen Medical Support in the Child Support ProgramAbstract: Limited revisions will be made to medical support regulations to improve interoperability between Child Support andMedicaid and CHIP to be consistent with the CHIP Reauthorization Act of 2009, and the Secretary's public goal of enrolling alleligible uninsured children in Medicaid and CHIP by 2014.

Priority: Other Significant Agenda Stage of Rulemaking: Completed ActionMajor: No Unfunded Mandates: NoCFR 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 ActLegal Deadline: None


Regulatory Flexibility Analysis Required: No Government Levels Affected: Federal; Local; StateSmall Entities Affected: No Federalism: NoEnergy Affected: NoAgency Contact: Jennifer Burnszynski OCSEDepartment of Health and Human ServicesAdministration for Children and Families901 D Street SW.Washington , DC 20447 Phone: 202 401-5068 E-Mail: [email protected]

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Title: Improving Payment Processing in the Child Support Enforcement ProgramAbstract: This proposed rule aims to address several significant barriers to effective payment processing experienced byemployers, states and families. The Notice of Proposed Rulemaking (NPRM) will propose changes regarding the incomewithholding documentation; direction of income withholding payments from employers; state processing of all incomewithholding payments, including payments on non-IV-D orders, through the SDU; and SDU disbursement of payments.

Priority: Other Significant Agenda Stage of Rulemaking: Completed ActionMajor: No Unfunded Mandates: NoCFR 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 ActLegal Deadline: None


Regulatory Flexibility Analysis Required: No Government Levels Affected: Federal; Local; StateSmall Entities Affected: No Federalism: NoEnergy Affected: NoAgency Contact: Yvette Riddick Director, Division of Policy, OCSEDepartment of Health and Human ServicesAdministration for Children and Families370 L'Enfant Promenade SW.Washington , DC 20447 Phone: 202 401-4885 E-Mail: [email protected]

Department of Health and Human Services (HHS) Administration on Aging ( AOA ) RIN: 0985-AA08


Title: Older Americans Act--Ombudsman ProgramAbstract: 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 42U.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 inquiriesfrom states and an AoA compliance review in one state have highlighted the difficulty of determining state compliance in carryingout the program functions.

Priority: Substantive, Nonsignificant Agenda Stage of Rulemaking: Proposed RuleMajor: No Unfunded Mandates: NoCFR Citation: 45 CFR 1327 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: 42 USC 3058gLegal Deadline: None


Regulatory Flexibility Analysis Required: No Government Levels Affected: State

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Small Entities Affected: No Federalism: NoEnergy Affected: NoAgency Contact: Deborah Burns Kuhn Aging Services Program SpecialistDepartment of Health and Human ServicesAdministration on Aging

Washington , DC 20201 Phone: 202 357-3549 E-Mail: [email protected]

Department of Health and Human Services (HHS) Administration on Aging ( AOA ) RIN: 0985-AA07


Title: Community Living Assistance Services and Supports (CLASS) Program--Designation of the CLASS IndependenceBenefit Plan and Enrollment RulesAbstract: The Department of Health and Human Services will issue rules to implement the Community Living AssistanceServices and Supports (CLASS) program, which was enacted as part of the Affordable Care Act. Specifically, the rules willdesignate the CLASS Independence Benefit Plan and establish enrollment rules for the program. Participation in the program isvoluntary.

Priority: Other Significant Agenda Stage of Rulemaking: Completed ActionMajor: No Unfunded Mandates: NoCFR 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 ina final rule by 10/01/12.

Action Source Description Date Other Statutory Required by 42 U.S.C. 300-2(a)(1)(3) 10/01/2012


Regulatory Flexibility Analysis Required: Undetermined Government Levels Affected: UndeterminedFederalism: UndeterminedEnergy Affected: NoAgency Contact: James Muetzel Management AnalystDepartment of Health and Human ServicesAdministration on AgingRoom 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


Title: Governance for a Nationwide Health Information NetworkAbstract: The National Coordinator for Health Information Technology (the National Coordinator) is required by section3001(c)(8) of the Public Health Service Act to establish a governance mechanism for the Nationwide Health InformationNetwork. Through this advance notice of proposed rulemaking (ANPRM), public comment will be sought on proposals andoptions relevant to the governance mechanism currently under consideration. Based on the public comments received, theNational Coordinator would issue a subsequent notice of proposed rulemaking (NPRM) to formally propose a governancemechanism for the Nationwide Health Information Network.

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http://www.regulations.gov/public/component/main?main=RuleDocuments&agency=HHS&pubperiod=201110&rin=0991-AB83

Priority: Routine and Frequent Agenda Stage of Rulemaking: PreRuleMajor: No Unfunded Mandates: NoCFR Citation: 45 CFR 170 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: 42 USC 300jj-11Legal Deadline: None

Timetable: Action Date FR Cite ANPRM 02/00/2012

Regulatory Flexibility Analysis Required: Undetermined Government Levels Affected: UndeterminedFederalism: UndeterminedEnergy Affected: NoAgency Contact: Steven Posnack Policy AnalystDepartment of Health and Human ServicesOffice of the SecretaryOffice 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 forElectronic Health Record TechnologyAbstract: The final rule that established the initial set of standards, implementation specifications, and certification criteria waspublished in the Federal Register on July 28, 2010. The initial set represented the first round of an incremental approach toadopting 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 newstandards, implementation specifications and certification criteria. The proposed new and revised standards, implementationspecifications, and certification criteria would establish the technical capabilities that certified EHR technology would need toinclude to support meaningful use under the CMS Medicare and Medicaid EHR Incentive Programs.

Priority: Other Significant Agenda Stage of Rulemaking: Proposed RuleMajor: Undetermined Unfunded Mandates: NoCFR Citation: 45 CFR 170 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: 42 USC 300jj-14Legal Deadline: None

Regulatory Plan:Statement of Need: The final rule that established the initial set of standards, implementation specifications, and certificationcriteria was published in the Federal Register on July 28, 2010. The initial set represented the first round of an incrementalapproach to adopting future sets of standards, implementation specifications, and certification criteria for electronic healthrecord (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 EHRtechnology would need to include in order to support meaningful use under the CMS Medicare and Medicaid EHR IncentivePrograms.

Legal Basis: Under the authority provided by section 3004 of the Public Health Service Act (PHSA), the Secretary wouldpropose to adopt revisions to the initial set of standards, implementation specifications, and certification criteria and proposenew standards, implementation specifications and certification criteria.

Alternatives: No alternatives are available because eligible professionals, eligible hospitals, and critical access hospitalsunder the CMS Medicare and Medicaid EHR Incentive Programs are required to demonstrate meaningful use of certified EHRtechnology. This rule ensures that the certification requirements necessary to support the achievement of meaningful use Stage

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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 technologyredesign, reprogramming, and new capability development. Benefits include greater standardization and increased EHRtechnology interoperability and functionality.

Risks: Absent a rulemaking, it is unlikely that currently certified EHR technology would include the requisite capacities tosupport an eligible professional's, eligible hospital's, or critical access hospital's achievement of meaningful use under the CMSMedicare and Medicaid EHR Incentive Programs.Timetable:


Regulatory Flexibility Analysis Required: Undetermined Government Levels Affected: NoFederalism: NoEnergy Affected: NoAgency Contact: Steven Posnack Policy AnalystDepartment of Health and Human ServicesOffice of the SecretaryOffice of the National Coordinator for Health Information Technology 200 Independence Avenue SW.Washington , DC 20201 Phone: 202 690-7151

Department of Health and Human Services (HHS) Office of the Secretary ( OS ) RIN: 0991-AA91


Title: Shared Risk Exception to the Safe Harbor ProvisionsAbstract: 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 anindividual or entity providing items or services in accordance with a written agreement between these parties. The rule allowsremuneration 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 ActionMajor: No Unfunded Mandates: NoCFR 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 Date FR Cite ANPRM 05/23/1997 62 FR 28410 ANPRM Comment Period End 06/09/1997 Interim Final Rule 11/19/1999 64 FR 63504 Interim Final Rule Comment Period End 01/18/2000 Transferred to RIN 0936-AA00 07/27/2011

Regulatory Flexibility Analysis Required: No Government Levels Affected: NoFederalism: NoRelated RINs: Related to 0991-AB06Agency Contact: Patrice S. Drew Regulations AnalystDepartment of Health and Human ServicesOffice of the Secretary330 Independence Avenue SW.

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Washington , DC 20201 Phone: 202 619-1368 E-Mail: [email protected]



Title: Principles for Determining Costs at Hospitals Under Federal Grants, Contracts, and Cooperative AgreementsAbstract: This notice of proposed rulemaking will publish for a 30-day comment period revisions to 45 CFR part 74, appendixE: Principles for Determining Costs at Hospitals Under Federal Grants, Contracts, and Cooperative Agreements (hereinafterreferred to as the Hospital Cost Principles or HCP). It is the culmination of a comprehensive review process begun in 2005, andincorporates relevant elements of 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). These otherprinciples were revised by OMB in the early 1990s, but the Hospital Cost Principles were not.

Priority: Routine and Frequent Agenda Stage of Rulemaking: Completed ActionMajor: No Unfunded Mandates: NoCFR 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 552Legal Deadline: None


Regulatory Flexibility Analysis Required: No Government Levels Affected: Local; StateFederalism: NoEnergy Affected: NoAgency Contact: Michelle G. Bulls Director, Office Of Grants Policy Oversight & EvaluationDepartment of Health and Human ServicesOffice of the Secretary200 Independence Avenue SW.Washington , DC 20202 Phone: 202 720-1908 E-Mail: [email protected]



Title: Rescission of Interest Prohibition in the Principles for Determining Costs at Hospitals Under Federal Grants, Contracts,and Cooperative AgreementsAbstract: This Notice of Proposed Rulemaking (NPRM) would rescind the current prohibition against interest as an allowableexpense. The recision applies only to interest endured for new construction, facility acquisitions, and interest debt to acquire orreplace facility acquisitions. It makes the Hospital Cost Principles consistent with the Office of Management and Budget circularsfor Colleges and Universities (OMB Circular A-21), Non-Profit Institutions (OMB Circular A-122), and State and LocalGovernments (OMB Circular A-87) concerning the allowance of interest debt. These other principles were revised in the early1990s, but the Hospital Cost Principles were not. In 2000, the current interest request waiver process was established as atemporary 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 inA-21 and A-87. This NPRM establish the Department of Health and Human Services as the proponent agency for appendix Eof 45 CFR part 74 with inherent responsibility to review, approve, and deny requests for waiver to Hospital Cost Principles.

Priority: Routine and Frequent Agenda Stage of Rulemaking: Completed ActionMajor: No Unfunded Mandates: No

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CFR Citation: 42 CFR 74 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: 5 USC 301 5 USC 552Legal Deadline: None


Regulatory Flexibility Analysis Required: No Government Levels Affected: Local; StateFederalism: NoEnergy Affected: NoAgency Contact: Michelle G. Bulls Director, Office Of Grants Policy Oversight & EvaluationDepartment of Health and Human ServicesOffice of the Secretary200 Independence Avenue SW.Washington , DC 20202 Phone: 202 720-1908 E-Mail: [email protected]



Title: Revision to Prohibition on FFP for "Data Mining" by Medicaid Fraud Control UnitsAbstract: 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 thescreening of claims, analysis of patterns of practice, or routine verification with recipients of whether services billed by providerswere actually received. The modifications would allow data mining to be conducted by MFCUs under limited circumstances.

Priority: Other Significant Agenda Stage of Rulemaking: Completed ActionMajor: No Unfunded Mandates: NoCFR 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 Date FR Cite NPRM 03/17/2011 76 FR 14637 NPRM Comment Period End 05/16/2011 Transferred to RIN 0936-AA01 07/27/2011

Regulatory Flexibility Analysis Required: No Government Levels Affected: StateFederalism: NoEnergy Affected: UndeterminedAgency Contact: Patrice S. Drew Regulations AnalystDepartment of Health and Human ServicesOffice of the Secretary330 Independence Avenue SW.Washington , DC 20201 Phone: 202 619-1368 E-Mail: [email protected]


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Title: HIPAA Privacy Rule Accounting of Disclosures under the Health Information Technology for Economic and Clinical HealthActAbstract: The Department of Health and Human Services, Office for Civil Rights, will issue rules to modify the HIPAA PrivacyRule as necessary to implement the accounting of disclosures provisions of section 13405(c) of the Health InformationTechnology for Economic and Clinical Health Act (Title XIII of the American Recovery and Reinvestment Act of 2009).

Priority: Other Significant Agenda Stage of Rulemaking: Completed ActionMajor: No Unfunded Mandates: NoCFR 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 Date FR Cite NPRM 05/31/2011 76 FR 31426 Transferred to RIN 0945-AA00 07/27/2011 NPRM Comment Period End 08/01/2011

Regulatory Flexibility Analysis Required: Undetermined Government Levels Affected: NoFederalism: NoAgency Contact: Andra Wicks Privacy Specialist, Office of Civil RightsDepartment of Health and Human ServicesOffice of the Secretary200 Independence Avenue SW.Washington , DC 20201 Phone: 202 205-2292 FAX: 202 205-4786E-Mail: [email protected]



Title: Individual Access to Protected Health Information Held by CLIA LaboratoriesAbstract: The Department of Health and Human Services, Office for Civil Rights, will modify the HIPAA Privacy Rule toconform the access provisions to be consistent with new Centers for Medicare & Medicaid Services regulations that will providefor laboratories subject to the Clinical Laboratory Improvements Amendments of 1988 to provide individuals with access to theirprotected health information.

Priority: Substantive, Nonsignificant Agenda Stage of Rulemaking: Completed ActionMajor: No Unfunded Mandates: NoCFR Citation: 45 CFR 164 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: PL 104-191 sec 264Legal Deadline: None

Timetable: Action Date FR Cite Transferred to RIN 0945-AA01 07/27/2011

Regulatory Flexibility Analysis Required: Undetermined Government Levels Affected: NoFederalism: NoAgency Contact: Andra Wicks Privacy Specialist, Office of Civil Rights

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Department of Health and Human ServicesOffice of the Secretary200 Independence Avenue SW.Washington , DC 20201 Phone: 202 205-2292 FAX: 202 205-4786E-Mail: [email protected]



Title: Nondiscrimination Under the Affordable Care ActAbstract: The Department of Health and Human Services, Office for Civil Rights, will issue rules for covered entities withrespect to prohibitions against discrimination on the basis of race, color, national origin, sex, age, and disability, as provided inSection 1557 of the Affordable Care Act. Section 1557 provides certain protections from discrimination by recipients of federalfinancial assistance, federally conducted programs, and entities established under Title I of the Affordable Care Act. This sectionalso identifies additional forms of federal financial assistance to which the section will apply.

Priority: Other Significant Agenda Stage of Rulemaking: Completed ActionMajor: No Unfunded Mandates: NoCFR Citation: None (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: PL 111-148, sec 1557Legal Deadline: None


Regulatory Flexibility Analysis Required: Undetermined Government Levels Affected: NoFederalism: NoEnergy Affected: UndeterminedAgency Contact: Carole Brown Equal Opportunity SpecialistDepartment of Health and Human ServicesOffice of the Secretary200 Independence Avenue SW.Washington , DC 20201 Phone: 202 619-0805 E-Mail: [email protected]



Title: Permanent Certification Program for Health Information Technology; Revisions to ONC-AA ProcessesAbstract: Under the authority granted to the National Coordinator for Health Information Technology by section 3001(c)(5) ofthe 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 ONC-Approved Accreditor (ONC-AA) to deny it accreditation. The National Coordinator is also proposing a process to addressinstances where the ONC-AA engages in improper conduct and/or does not perform its responsibilities under the permanentcertification program.

Priority: Other Significant Agenda Stage of Rulemaking: Completed ActionMajor: No Unfunded Mandates: NoCFR Citation: 45 CFR 170 (To search for a specific CFR, visit the Code of Federal Regulations )

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Legal Authority: 42 USC 300jj-11Legal Deadline: None


Regulatory Flexibility Analysis Required: No Government Levels Affected: NoFederalism: NoAgency Contact: Steven Posnack Policy AnalystDepartment of Health and Human ServicesOffice of the SecretaryOffice 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 ExchangeAbstract: This advance notice of proposed rulemaking would propose the adoption of metadata standards to supportnationwide electronic health information exchange. The proposed standards serve as first step toward implementing certainrecommendations 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."

Priority: Other Significant Agenda Stage of Rulemaking: Completed ActionMajor: No Unfunded Mandates: NoCFR Citation: 45 CFR 170 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: 42 USC 300jj-14Legal Deadline: None

Timetable: Action Date FR Cite ANPRM 08/09/2011 76 FR 48769 ANPRM Comment Period End 09/23/2011 Merged With 0991-AB84 12/31/2011

Regulatory Flexibility Analysis Required: Undetermined Government Levels Affected: UndeterminedFederalism: NoEnergy Affected: NoAgency Contact: Steven Posnack Policy AnalystDepartment of Health and Human ServicesOffice of the SecretaryOffice of the National Coordinator for Health Information Technology 200 Independence Avenue SW.Washington , DC 20201 Phone: 202 690-7151



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Title: Modifications to the HIPAA Privacy, Security, Enforcement, and Breach Notification RulesAbstract: The Department of Health and Human Services Office for Civil Rights will issue final rules to modify the HIPAAPrivacy, 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 (TitleXIII of the American Recovery and Reinvestment Act of 2009), and will modify the HIPAA Privacy Rule as required by section105 of the Genetic Information Nondiscrimination Act of 2008.

Priority: Economically Significant Agenda Stage of Rulemaking: Completed ActionMajor: Yes Unfunded Mandates: NoCFR 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-9Legal Deadline:

Action Source Description Date Other Statutory Effective date of certain HITECH enforcement provisions 02/18/2009 Other Statutory Deadline for final GINA rule 05/21/2009 Other Statutory Deadline for Interim Final Rule on Breach Notification 08/17/2009

Other Statutory Effective date of certain HITECH privacy, security, and enforcementprovisions

02/18/2010

Other Statutory Effective date of certain HITECH enforcement provisions 02/18/2011


Regulatory Flexibility Analysis Required: No Government Levels Affected: NoFederalism: NoAgency Contact: Andra Wicks Privacy Specialist, Office of Civil RightsDepartment of Health and Human ServicesOffice of the Secretary200 Independence Avenue SW.Washington , DC 20201 Phone: 202 205-2292 FAX: 202 205-4786E-Mail: [email protected]



Title: Medicare and State Health Care Programs: Fraud and Abuse; Revisions to the Office of Inspector General's SafeHarbors Under the Antikickback Status, Exclusion Authorities, and Civil Monetary PenaltyAbstract: This rule would add new, and modify existing, safe harbors under the anti-kickback statute; add new, and reviseexisting, 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 inducementsprohibition.

Priority: Substantive, Nonsignificant Agenda Stage of Rulemaking: Completed ActionMajor: No Unfunded Mandates: NoCFR Citation: 42 CFR 1001.952; 42 CFR 1001 and 1002; 42 CFR 1005; 42 CFR 1003.101; 42 CFR 1003; ... (To search for aspecific 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 105-33, sec 4331, PL 99-660; PL 107-188; 42 USC 1320a-7a; 42 USC 1395mm; 42 USC 1395w-27; 42 USC 1396bLegal Deadline:



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Transferred to RIN 0936-AA02 07/27/2011

Regulatory Flexibility Analysis Required: No Government Levels Affected: NoFederalism: NoAgency Contact: Patrice S. Drew Regulations AnalystDepartment of Health and Human ServicesOffice of the Secretary330 Independence Avenue SW.Washington , DC 20201 Phone: 202 619-1368 E-Mail: [email protected]



Title: Permanent Certification Program for Health Information Technology; Revisions to ONC-AA ProcessesAbstract: 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 wherethe ONC-Approved Accreditor (ONC-AA) engages in improper conduct or does not perform its responsibilities under thepermanent 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 theresponsibilities of the new ONC-AA.

Priority: Other Significant Agenda Stage of Rulemaking: Completed ActionMajor: No Unfunded Mandates: NoCFR Citation: 42 CFR 170 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: 42 USC 300jj-11Legal Deadline: None

Timetable: Action Date FR Cite NPRM 05/31/2011 76 FR 31272 Merged With 0991-AB77 07/10/2011 NPRM Comment Period End 08/01/2011

Regulatory Flexibility Analysis Required: No Government Levels Affected: NoFederalism: NoEnergy Affected: NoAgency Contact: Steven Posnack Policy AnalystDepartment of Health and Human ServicesOffice of the SecretaryOffice of the National Coordinator for Health Information Technology 200 Independence Avenue SW.Washington , DC 20201 Phone: 202 690-7151

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