[The Regulatory Plan and Unified Agenda of Federal Regulatory and Deregulatory Actions]
[Department of Health and Human Services Semiannual Regulatory Agenda]
[From the U.S. Government Printing Office, www.gpo.gov]


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Part VIII





Department of Health and Human Services





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Semiannual Regulatory Agenda

[[Page 73196]]



DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)                          


  



_______________________________________________________________________

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 
12866 require the following inventory of the rulemaking actions under 
development by the Department. The purpose is to encourage public 
participation in the regulatory process by providing, at as early a 
stage as possible, summarized information about regulatory actions 
under consideration. Members of the public wishing to communicate to 
the Department their views on the potential rulemakings outlined below 
are invited to do so.

FOR FURTHER INFORMATION CONTACT: Ann C. Agnew, Executive Secretary, 
Department of Health and Human Services, Washington, DC 20201.

SUPPLEMENTARY INFORMATION: The capsulized information provided below 
presents for public scrutiny a forecast of the rulemaking activities 
that the Department expects to undertake over the foreseeable future. 
We focus primarily on those areas of work expected to result in 
publication of Notices of Proposed Rulemaking or Final Rules within the 
next 12 months.

     We welcome the views of all concerned with regard to these 
planned rulemakings. Comments may be directed to the agency 
officials cited in each of the summaries, or, if early attention at 
the Secretary's level is seen as required, comments should be sent 
to: Ann C. Agnew, Executive Secretary to the Department, Room 603H, 
200 Independence Avenue SW., Washington, DC 20201.

Dated: September 15, 2006.

 Ann C. Agnew,

Executive Secretary to the Department.

                                  Office of the Secretary--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
985         Revisions to Regulations Addressing the OIG's Authority To Impose Civil Money             0991-AB03
            Penalties and Assessments.............................................................
----------------------------------------------------------------------------------------------------------------


                                    Office of the Secretary--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
986         Shared Risk Exception to the Safe Harbor Provisions...................................    0991-AA91
987         Safe Harbor for Waiver of Beneficiary Coinsurance and Deductible Amounts for a            0991-AB16
            Medicare SELECT Policy................................................................
988         Debt Collection.......................................................................    0991-AB18
989         Salary Offset.........................................................................    0991-AB19
990         Clarification of Terms and Application of Program Exclusion Authority for Submitting      0991-AB23
            Claims Containing Excessive Charges...................................................
991         Medicare and State Health Care Programs: Fraud and Abuse; Safe Harbor for Federally       0991-AB38
            Qualified Health Centers Under the Anti-Kickback Statute..............................
----------------------------------------------------------------------------------------------------------------


                                   Office of the Secretary--Long-Term Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
992         Revisions to the Waiver Provisions of the Office of Inspector General's (OIG)             0991-AB33
            Exclusion Authorities.................................................................
----------------------------------------------------------------------------------------------------------------


                                   Office of the Secretary--Completed Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
993         Medicare and State Health Care Programs: Fraud and Abuse; Safe Harbor for Certain         0991-AB39
            Electronic Prescribing Arrangements Under the Anti-Kickback Statute...................
----------------------------------------------------------------------------------------------------------------


[[Page 73197]]


                 Substance Abuse and Mental Health Services Administration--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
994         Requirements Governing the Use of Seclusion and Restraint in Certain Nonmedical           0930-AA10
            Community-Based Facilities for Children and Youth.....................................
----------------------------------------------------------------------------------------------------------------


                   Substance Abuse and Mental Health Services Administration--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
995         Mandatory Guidelines for the Federal Workplace Drug Testing Program...................    0930-AA12
----------------------------------------------------------------------------------------------------------------


                            Centers for Disease Control and Prevention--Prerule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
996         Foreign Quarantine Regulations, Proposed Revision of HHS/CDC Animal Importation           0920-AA14
            Regulations...........................................................................
997         Amendments to Powered Air-Purifying Respirator Requirements for Approval of               0920-AA16
            Respiratory Protection Devices........................................................
998         Amendments to Performance Requirements for Chemical Biological, Radiological, and         0920-AA17
            Nuclear (CBRN) Approval of Respiratory Protection Devices.............................
----------------------------------------------------------------------------------------------------------------


                         Centers for Disease Control and Prevention--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
999         Amendments to Quality Assurance and Administrative Provision for Approval of              0920-AA04
            Respiratory Protective Devices........................................................
1000        Amendments to Self-Contained Breathing Apparatus Requirements for Approval of             0920-AA10
            Respiratory Protective Devices........................................................
1001        Amendments to Requirements for Coal Mine Dust Personal Sampler Units..................    0920-AA18
----------------------------------------------------------------------------------------------------------------


                          Centers for Disease Control and Prevention--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
1002        Control of Communicable Diseases, Interstate and Foreign Quarantine (Reg Plan Seq No.     0920-AA12
            35)...................................................................................
1003        Procedures for Designating Classes of Employees as Members of the Special Exposure        0920-AA13
            Cohort Under the Energy Employees Occupational Illness Compensation Program Act of
            2000; Amendments......................................................................
1004        Interstate Shipment of Etiologic Agents...............................................    0920-AA19
----------------------------------------------------------------------------------------------------------------
References in boldface appear in the Regulatory Plan in part II of this issue of the Federal Register.


                                   Food and Drug Administration--Prerule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
1005        Over-the-Counter (OTC) Drug Review--Sunscreen Products................................    0910-AF43
1006        Medical Devices; Current Good Manufacturing Practice (CGMP) Final Rule; Quality           0910-AF71
            Systems Regulations (Section 610 Review)..............................................
1007        Package Size Limitation for Sodium Phosphates Oral Solution and Warning and Direction     0910-AF73
            Statements for Oral and Rectal Sodium Phosphates for Over-the-Counter Laxative Use
            (Section 610 Review)..................................................................
1008        Over-the-Counter Drug Products Containing Analgesic/Antipyretic Active Ingredients for    0910-AF74
            Internal Use: Required Alcohol Warning (Section 610 Review)...........................
1009        Status of Certain Additional Over-the-Counter Drug Category II and III Active             0910-AF75
            Ingredients (Section 610 Review)......................................................

[[Page 73198]]

 
1010        Medical Devices: Classification/Reclassification; Restricted Devices; Analyte Specific    0910-AF76
            Reagents (Section 610 Review).........................................................
1011        Amended Economic Impact Analysis of Final Rule on User Labeling on Natural Rubber-        0910-AF77
            Containing Medical Device (Section 610 Review)........................................
1012        Financial Disclosure by Clinical Investigators (Section 610 Review)...................    0910-AF79
1013        Beverages: Bottled Water (Section 610 Review).........................................    0910-AF80
1014        Food Labeling; Nutrient Content Claims: Definition for ``High Potency'' and Definition    0910-AF83
            of ``Antioxidant'' for Use in Nutrient Content Claims for Dietary Supplements and
            Conventional Foods (Section 610 Review)...............................................
----------------------------------------------------------------------------------------------------------------


                                Food and Drug Administration--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
1015        Medical Devices; Anesthesiology Devices; Proposed Reclassification of Pressure            0910-AC30
            Regulators for Use With Medical Oxygen and Separate Classification of Oxygen
            Conserving Devices....................................................................
1016        Electronic Submission of Data From Studies Evaluating Human Drugs and Biologics (Reg      0910-AC52
            Plan Seq No. 36)......................................................................
1017        Reporting Information Regarding Falsification of Data.................................    0910-AC59
1018        Content and Format of Labeling for Human Prescription Drugs and Biologics;                0910-AF11
            Requirements for Pregnancy and Lactation Labeling (Reg Plan Seq No. 37)...............
1019        Charging for Investigational Drugs....................................................    0910-AF13
1020        Expanded Access to Investigational Drugs for Treatment Use (Reg Plan Seq No. 38)......    0910-AF14
1021        Blood Initiative--Requirements for Human Blood and Blood Components Intended for          0910-AF25
            Transfusion or for Further Manufacturing Use..........................................
1022        Over-the-Counter (OTC) Drug Review--Internal Analgesic Products.......................    0910-AF36
1023        Over-the-Counter (OTC) Drug Review--Labeling of Drug Products for OTC Human Use.......    0910-AF37
1024        Over-the-Counter (OTC) Drug Review--Ophthalmic Products...............................    0910-AF39
1025        Over-the-Counter (OTC) Drug Review--Oral Health Care Products.........................    0910-AF40
1026        Over-the-Counter (OTC) Drug Review--Skin Bleaching Products...........................    0910-AF53
1027        Use of Materials Derived From Cattle in Medical Products Intended for Use in Humans       0910-AF54
            and Drugs Intended for Use in Ruminants...............................................
1028        Over-the-Counter (OTC) Drug Review--Stimulant Drug Products...........................    0910-AF56
1029        Label Requirement for Food That Has Been Refused Admission Into the United States (Reg    0910-AF61
            Plan Seq No. 39)......................................................................
1030        Over-the-Counter Antidiarrheal Drug Products..........................................    0910-AF63
1031        Index of Legally Marketed Unapproved New Animal Drugs for Minor Species...............    0910-AF67
1032        Over-the-Counter (OTC) Drug Review--Poison Treatment Drug Products....................    0910-AF68
1033        Over-the-Counter (OTC) Drug Review--Topical Antimicrobial Drug Products...............    0910-AF69
1034        Over-the-Counter (OTC) Drug Review--Urinary Analgesic Drug Products...................    0910-AF70
1035        Import Tolerances for Animal Drugs....................................................    0910-AF78
1036        Current Good Manufacturing Practice for Combination Products..........................    0910-AF81
1037        Postmarket Safety Reporting for Combination Products..................................    0910-AF82
1038        Revisions to the Requirements Applicable to Blood, Blood Components, and Source Plasma    0910-AF84
1039        Revision of the Requirements for Live Vaccine Processing..............................    0910-AF85
1040        Medical Device Reporting; Electronic Submission Requirements (Reg Plan Seq No. 40)....    0910-AF86
1041        Laser Products; Amendment to Performance Standard.....................................    0910-AF87
1042        Electronic Registration and Listing for Devices (Reg Plan Seq No. 41).................    0910-AF88
1043        Regulations on Fixed-Combination Drug Products........................................    0910-AF89
1044        Use of Ozone-Depleting Substances; Removal of Essential Use Designations [epinephrine]    0910-AF92
1045        Use of Ozone-Depleting Substances; Removal of Essential Use Designations [flunisolide,    0910-AF93
            triamcinolone, metaproterenol, pirbuterol, albuterol and ipratropium in combination,
            cromolyn, and nedocromil].............................................................
----------------------------------------------------------------------------------------------------------------
References in boldface appear in the Regulatory Plan in part II of this issue of the Federal Register.


[[Page 73199]]


                                 Food and Drug Administration--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
1046        Foreign and Domestic Establishment Registration and Listing Requirements for Human        0910-AA49
            Drugs, Including Drugs That Are Regulated Under a Biologics License Application, and
            Animal Drugs..........................................................................
1047        Safety Reporting Requirements for Human Drug and Biological Products..................    0910-AA97
1048        Applications for FDA Approval To Market a New Drug; Complete Response Letter;             0910-AB34
            Amendments to Unapproved Applications.................................................
1049        CGMPs for Blood and Blood Components: Notification of Consignees and Transfusion          0910-AB76
            Recipients Receiving Blood and Blood Components at Increased Risk of Transmitting HCV
            Infection (Lookback)..................................................................
1050        Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Dietary         0910-AB88
            Ingredients and Dietary Supplements (Reg Plan Seq No. 42).............................
1051        Additional Safeguards for Children in Clinical Investigations.........................    0910-AC07
1052        Prevention of Salmonella Enteritidis in Shell Eggs....................................    0910-AC14
1053        Institutional Review Boards: Registration Requirements................................    0910-AC17
1054        Exception From General Requirements for Informed Consent; Request for Comments and        0910-AC25
            Information...........................................................................
1055        Medical Devices; Patient Examination and Surgeons' Gloves; Test Procedures and            0910-AC32
            Acceptance Criteria...................................................................
1056        Toll-Free Number for Reporting Adverse Events on Labeling for Human Drugs.............    0910-AC35
1057        Prior Notice of Imported Food Under the Public Health Security and Bioterrorism           0910-AC41
            Preparedness and Response Act of 2002 (Reg Plan Seq No. 43)...........................
1058        Medical Gas Containers and Closures; Current Good Manufacturing Practice Requirements.    0910-AC53
1059        Positron Emission Tomography Drugs; Current Good Manufacturing Practices..............    0910-AC55
1060        Human Subject Protection; Foreign Clinical Studies Not Conducted Under an                 0910-AF15
            Investigational New Drug Application..................................................
1061        Distribution of Blood Derivatives by Registered Blood Establishments That Qualify as      0910-AF16
            Health Care Entities; PDMA of 1987; PDA of 1992; Policies, Requirements, and
            Administrative Procedures.............................................................
1062        Obstetrical and Gynecological Devices; Designation of Special Control for Condoms and     0910-AF21
            Condoms With Spermicidal Lubricant....................................................
1063        Blood Initiative--Revisions to Labeling Requirements for Blood and Blood Components,      0910-AF26
            Including Source Plasma; and Technical Amendment......................................
1064        Infant Formula: Current Good Manufacturing Practices; Quality Control Procedures;         0910-AF27
            Notification Requirements; Records and Reports........................................
1065        Infant Formula Quality Factors........................................................    0910-AF28
1066        Over-the-Counter (OTC) Drug Review--Cough/Cold (Antihistamine) Products...............    0910-AF31
1067        Over-the-Counter (OTC) Drug Review--Cough/Cold (Bronchodilator) Products..............    0910-AF32
1068        Over-the-Counter (OTC) Drug Review--Cough/Cold (Combination) Products.................    0910-AF33
1069        Over-the-Counter (OTC) Drug Review--Cough/Cold (Nasal Decongestant) Products..........    0910-AF34
1070        Over-the-Counter (OTC) Drug Review--External Analgesic Products.......................    0910-AF35
1071        Over-the-Counter (OTC) Drug Review--Laxative Drug Products............................    0910-AF38
1072        Over-the-Counter (OTC) Drug Review--Skin Protectant Products..........................    0910-AF42
1073        Over-the-Counter (OTC) Drug Review--Vaginal Contraceptive Products....................    0910-AF44
1074        Over-the-Counter (OTC) Drug Review--Weight Control Products...........................    0910-AF45
1075        Over-the-Counter (OTC) Drug Review--Dandruff, Seborrheic Dermatitis, and Psoriasis        0910-AF49
            Products..............................................................................
1076        Over-the-Counter (OTC) Drug Review--Overindulgence in Food and Drink Products.........    0910-AF51
1077        Over-the-Counter (OTC) Drug Review--Antacid Products..................................    0910-AF52
1078        Supplements and Other Changes to Approved New Animal Drug Applications................    0910-AF59
1079        Designation of New Animal Drugs for Minor Uses or Minor Species.......................    0910-AF60
1080        Blood Vessels Recovered With Organs and Intended for Use in Organ Transplantation.....    0910-AF65
1081        Exceptions or Alternatives to Labeling Requirements for Products Held by the Strategic    0910-AF90
            National Stockpile....................................................................
----------------------------------------------------------------------------------------------------------------
References in boldface appear in the Regulatory Plan in part II of this issue of the Federal Register.


                                 Food and Drug Administration--Long-Term Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
1082        Chronic Wasting Disease: Control of Food Products and Cosmetics Derived From Exposed      0910-AC21
            Animal Populations....................................................................
1083        Requirements for Submission of In Vivo Bioequivalence Data............................    0910-AC23
1084        Food Labeling: Trans Fatty Acids in Nutrition Labeling: Consumer Research To Consider     0910-AC50
            Nutrient Content and Health Claims and Possible Footnote or Disclosure Statements.....
1085        Food Standards: General Principles and Food Standards Modernization...................    0910-AC54

[[Page 73200]]

 
1086        Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding     0910-AF08
            of Drugs; Revision of Certain Labeling Controls.......................................
1087        Health Claims.........................................................................    0910-AF09
1088        Cochineal Extract and Carmine Label Declaration.......................................    0910-AF12
1089        Food Labeling; Prominence of Calories.................................................    0910-AF22
1090        Food Labeling; Serving Sizes of Products That Can Reasonably Be Consumed at One Eating    0910-AF23
            Occasion; Updating of Reference Amounts Customarily Consumed; Approaches for
            Recommending Smaller Portion Sizes....................................................
1091        Substances Prohibited From Use in Animal Food or Feed.................................    0910-AF46
1092        Use of Materials Derived From Cattle in Human Food and Cosmetics......................    0910-AF47
----------------------------------------------------------------------------------------------------------------


                                 Food and Drug Administration--Completed Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
1093        Revocation of the Status of Specific Products; Group A Streptococcus..................    0910-AF20
1094        Recordkeeping Requirements for Human Food and Cosmetics Manufactured From, Processed      0910-AF48
            With, or Otherwise Containing Material From Cattle....................................
----------------------------------------------------------------------------------------------------------------


                        Health Resources and Services Administration--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
1095        Designation of Medically Underserved Populations and Health Professional Shortage         0906-AA44
            Areas.................................................................................
----------------------------------------------------------------------------------------------------------------


                         Health Resources and Services Administration--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
1096        National Practitioner Data Bank for Adverse Information on Physicians and Other Health    0906-AA57
            Care Practitioners: Reporting Adverse and Negative Actions............................
1097        Intestines Added to the Definition of Organs Covered by the Rules Governing the           0906-AA62
            Operation of the Organ Procurement and Transplantation Network (OPTN).................
1098        Requirements Establishing a Limitation on Administrative Expenses; Ryan White CARE Act    0906-AA65
            Title IV Grants for Coordinated Services and Access to Research.......................
1099        National Vaccine Injury Compensation Program: Calculation of Average Cost of a Health     0906-AA68
            Insurance Policy......................................................................
1100        Healthy Tomorrow's Partnership for Children (HTPC) Program............................    0906-AA70
----------------------------------------------------------------------------------------------------------------


                         Health Resources and Services Administration--Long-Term Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
1101        National Practitioner Data Bank for Adverse Information on Physicians and Other Health    0906-AA41
            Care Practitioners: Medical Malpractice Payments Reporting Requirements...............
1102        Operation of the Organ Procurement and Transplantation Network (OPTN).................    0906-AA63
----------------------------------------------------------------------------------------------------------------


[[Page 73201]]


                         Health Resources and Services Administration--Completed Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
1103        Smallpox Vaccine Injury Compensation Program: Smallpox (Vaccinia) Vaccine Injury Table    0906-AA60
1104        Smallpox Vaccine Injury Compensation Program: Administrative Implementation...........    0906-AA61
----------------------------------------------------------------------------------------------------------------


                                     Indian Health Service--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
1105        Section 506--Limitation on Charges for Services Furnished by Medicare-Participating       0917-AA07
            Inpatient Hospital to Indians.........................................................
----------------------------------------------------------------------------------------------------------------


                               National Institutes of Health--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
1106        Grants for Research Projects..........................................................    0925-AA42
1107        National Institutes of Health Loan Repayment Programs.................................    0925-AA43
1108        National Library of Medicine Training Grants..........................................    0925-AA44
1109        Minority Biomedical Research Support Program..........................................    0925-AA45
1110        National Institute of Environmental Health Sciences Hazardous Substances Basic            0925-AA46
            Research and Training Grants..........................................................
1111        Endowment Program.....................................................................    0925-AA47
1112        Undergraduate Scholarship Program Regarding Professions Needed by the National            0925-AA48
            Institutes of Health..................................................................
1113        NIH Training Grants...................................................................    0925-AA49
1114        NIH Center Grants.....................................................................    0925-AA50
1115        NIH Construction Grant................................................................    0925-AA51
----------------------------------------------------------------------------------------------------------------


                                 National Institutes of Health--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
1116        Standards for a National Chimpanzee Sanctuary System..................................    0925-AA31
----------------------------------------------------------------------------------------------------------------


                                National Institutes of Health--Completed Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
1117        National Institutes of Health Training Grants.........................................    0925-AA28
----------------------------------------------------------------------------------------------------------------


                               Office of Public Health and Science--Prerule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
1118        Human Subjects Protection Regulations: Additional Protections for Adult Individuals       0940-AA11
            With Impaired Decisionmaking Capacity.................................................
----------------------------------------------------------------------------------------------------------------


[[Page 73202]]


                              Office of Public Health and Science--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
1119        Human Subjects Protection Regulations: Institutional Review Boards Registration           0940-AA06
            Requirements..........................................................................
----------------------------------------------------------------------------------------------------------------


                             Office of Public Health and Science--Long-Term Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
1120        Public Health Service Standards for the Protection of Research Misconduct                 0940-AA01
            Whistleblowers........................................................................
1121        Human Subjects Protection Regulations: Training and Ed. Requirements for Institutional    0940-AA08
            Officials, Institutional Review Board Members and Staff, Human Protections
            Administrators, and Investigators.....................................................
----------------------------------------------------------------------------------------------------------------


                          Centers for Medicare & Medicaid Services--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
1122        Home Health Agency (HHA) Conditions of Participation (CoPs) (CMS-3819-P) (Section 610     0938-AG81
            Review)...............................................................................
1123        Appeals of CMS or Contractor Determinations When a Provider or Supplier Fails To Meet     0938-AI49
            the Requirements for Medicare Billing (CMS-6003-P2)...................................
1124        Rural Health Clinics: Amendments to Participation Requirements and Payment Provisions     0938-AJ17
            and Establishment of a Quality Assessment and Improvement Program (CMS-1910-P2).......
1125        Use of Restraints and Seclusion in Medicare and Medicaid Participating Facilities That    0938-AL26
            Provide Inpatient or Residential Care (CMS-2130-P)....................................
1126        Revisions to Conditions for Coverage for Ambulatory Surgical Centers (CMS-3887-P).....    0938-AL80
1127        Modifications to Electronic Transactions and Code Sets (CMS-0009-P)...................    0938-AM50
1128        Requirements for Long-Term Care Facilities: Hospice Services (CMS-3140-P).............    0938-AM87
1129        Revisions to HIPAA Code Sets (CMS-0013-P).............................................    0938-AN25
1130        National Plan and Provider Enumeration System (NPPES) Data Dissemination (CMS-6060-NC)    0938-AN71
1131        Changes to the Disclosure of Information Requirements for Quality Improvement             0938-AN73
            Organizations (CMS-3156-P)............................................................
1132        Fire Safety Requirements for Long-Term Care Facilities: Sprinkler Systems (CMS-3191-P)    0938-AN79
1133        Payments for Service Provided Without Charge (CMS-2489-P).............................    0938-AO07
1134        Medical Improvement Eligibility Group and Definition of Work (CMS-2143-P).............    0938-AO10
1135        Outpatient Hospital Services and Rural Health Clinic Services Amendment (CMS-2213-P)..    0938-AO17
1136        Medicaid Prescription Drugs -- Average Manufacturer Price (CMS-2238-P)................    0938-AO20
1137        Use of Repayment Plans (CMS-6032-P)...................................................    0938-AO27
1138        Redistribution of Unexpended State Children's Health Insurance Program (SCHIP) Funds      0938-AO28
            From the Appropriation for Fiscal Year 2004 (CMS-2241-NC).............................
1139        Prospective Payment System for Long-Term Care Hospitals RY 2008: Annual Payment Rate      0938-AO30
            Updates (CMS-1529-P) (Reg Plan Seq No. 44)............................................
1140        Home Health Prospective Payment System Rate Update for Calendar Year 2008 (CMS-1541-P)    0938-AO32
1141        Gynecological Cytology Proficiency Testing Requirements for Laboratories, Individuals,    0938-AO34
            and Proficiency Testing Program Approvals (CMS-2252-P)................................
1142        State Option To Establish Non-Emergency Medical Transportation Program (CMS-2234-P)...    0938-AO45
1143        Cost Sharing Options (CMS-2244-P).....................................................    0938-AO47
1144        State Flexibility for Medicaid Benefit Packages (CMS-2232-P)..........................    0938-AO48
1145        Home and Community-Based Services (HCBS) State Plan Option (CMS-2249-P)...............    0938-AO53
1146        Medicare Part D Data (CMS-4119-P).....................................................    0938-AO58
1147        Prospective Payment System for Inpatient Rehabilitation Facilities for FY 2008 (CMS-      0938-AO63
            1551-P)...............................................................................
1148        Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities--      0938-AO64
            Update for FY 2008 (CMS-1545-P).......................................................
1149        Revisions to Payment Policies Under the Physician Fee Schedule for Calendar Year 2008     0938-AO65
            (CMS-1385-P)..........................................................................
1150        Standards for E-Prescribing Under Medicare Part D (CMS-0016-P) (Reg Plan Seq No. 45)..    0938-AO66
1151        Exemption of Privacy Act Disclosure of Certain Investigative Materials (CMS-0029-P)...    0938-AO69
1152        Changes to the Hospital Inpatient Prospective Payment Systems and FY 2008 Rates (CMS-     0938-AO70
            1533-P) (Reg Plan Seq No. 46).........................................................
1153        Changes to the Hospital Outpatient Prospective Payment System and Calendar Year 2008      0938-AO71
            Payment Rates (CMS-1392-P)............................................................

[[Page 73203]]

 
1154        Hospice Wage Index for FY 2008 (CMS-1539-P)...........................................    0938-AO72
1155        Special Enrollment Period and Medicare Premium Changes (CMS-4129-P)...................    0938-AO77
1156        Revisions to the Medicare Advantage and Part D Prescription Drug Contract                 0938-AO78
            Confidentiality and Disclosure, Determinations, Appeals, and Intermediate Sanctions
            Processes (CMS-4124-P) (Reg Plan Seq No. 47)..........................................
----------------------------------------------------------------------------------------------------------------
References in boldface appear in the Regulatory Plan in part II of this issue of the Federal Register.


                           Centers for Medicare & Medicaid Services--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
1157        Hospital Conditions of Participation: Laboratory Services (CMS-3014-IFC) (Section 610     0938-AJ29
            Review)...............................................................................
1158        Use of Restraints and Seclusion in Residential Treatment Facilities Providing             0938-AJ96
            Inpatient Psychiatric Services to Individuals Under Age 21 (CMS-2065-F)...............
1159        Physicians' Referrals to Health Care Entities With Which They Have Financial              0938-AK67
            Relationships (CMS-1810-F)............................................................
1160        Provider Reimbursement Determinations and Appeals (CMS-1727-F)........................    0938-AL54
1161        Revised Civil Money Penalties, Assessments, Exclusions, and Related Appeals Procedures    0938-AM98
            (CMS-6146-F)..........................................................................
1162        Enhanced DSH Treatment for Certain Hospitals (CMS-2198-F).............................    0938-AN09
1163        Competitive Acquisition for Certain Durable Medical Equipment (DME), Prosthetics,         0938-AN14
            Orthotics, and Supplies (CMS-1270-F) (Reg Plan Seq No. 48)............................
1164        Nondiscrimination in Health Coverage in the Group Market (CMS-4081-F).................    0938-AN29
1165        Hospital Conditions of Participation: Patients' Rights (CMS-3018-F)...................    0938-AN30
1166        Program for All-Inclusive Care for the Elderly (PACE): Program Revisions (CMS-1201-F).    0938-AN83
1167        Special Medicare GME Affillations for a Teaching Hospital Affected by a Disaster (CMS-    0938-AO35
            1531-F2)..............................................................................
1168        Inpatient Psychiatric Facility Prospective Payment System--Update for Rate Year           0938-AO40
            Beginning July 1, 2007 (RY 2008) (CMS-1479-N).........................................
1169        Group Health Plans and Health Insurance Issues Under the Newborns and Mothers Health      0938-AO43
            Protection Act (CMS-4116-F)...........................................................
1170        High Risk Pools (CMS-2260-IFC)........................................................    0938-AO46
1171        Targeted Case Management (CMS-2237-IFC)...............................................    0938-AO50
1172        Citizenship Documentation Requirements (CMS-2257-F)...................................    0938-AO51
1173        Self-Directed Personal Assistance Services State Plan Option (CMS-2229-IFC)...........    0938-AO52
1174        Inpatient Hospital Deductible and Hospital and Extended Care Services Coinsurance         0938-AO61
            Amounts for CY 2008 (CMS-8032-N)......................................................
1175        Part A Premiums for CY 2008 for the Uninsured Aged and for Certain Disabled               0938-AO62
            Individuals Who Have Exhausted Other Entitlement (CMS-8031-N).........................
1176        Part B Monthly Actuarial Rates and Premium Rates Beginning January 1, 2008 (CMS-8033-     0938-AO68
            N)....................................................................................
1177        Revised Payment System for Services Furnished in Ambulatory Surgical Centers (ASCs)       0938-AO73
            Effective January 1, 2008 (CMS-1517-F)................................................
1178        Fiscal Year 2008 SCHIP Allotments (CMS-2262-N)........................................    0938-AO76
----------------------------------------------------------------------------------------------------------------
References in boldface appear in the Regulatory Plan in part II of this issue of the Federal Register.


                           Centers for Medicare & Medicaid Services--Long-Term Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
1179        End Stage Renal Disease (ESRD) Conditions for Coverage (CMS-3818-F) (Section 610          0938-AG82
            Review)...............................................................................
1180        Hospital Conditions of Participation: Requirements for Approval and Reapproval of         0938-AH17
            Transplant Centers To Perform Organ Transplants (CMS-3835-F)..........................
1181        Hospice Care Conditions of Participation (CMS-3844-F) (Section 610 Review)............    0938-AH27
1182        Electronic Claims Attachments Standards (CMS-0050-F)..................................    0938-AK62
1183        Health Coverage Portability: Tolling Certain Time Periods and Interactions With Family    0938-AL88
            and Medical Leave Act (CMS-2158-F)....................................................
1184        Revisions to the Appeals Process for Initial Claim Determinations (CMS-4064-F)........    0938-AM73
1185        Hospital Conditions of Participation: Requirements for History and Physical               0938-AM88
            Examinations; Authentication of Verbal Orders; Securing Medications; and Post-
            Anesthesia Evaluations (CMS-3122-F)...................................................

[[Page 73204]]

 
1186        Prior Determination Process for Certain Items and Services (CMS-6024-F)...............    0938-AN10
1187        Medicare Secondary Payer Amendments (CMS-6272-F)......................................    0938-AN27
1188        Termination of Non-Random Prepayment Medical Review (CMS-6022-F)......................    0938-AN31
1189        Limitation on Recoupment of Overpayments (CMS-6025-F).................................    0938-AN42
1190        Medicare Part B Competitive Acquisition of Outpatient Drugs and Biologicals (CMS-1325-    0938-AN58
            F)....................................................................................
1191        Medicare Integrity Program, Fiscal Intermediary and Carrier Functions, and Conflict of    0938-AN72
            Interest Requirements (CMS-6030-F)....................................................
1192        Payment Error Rate Measurement (PERM) Program (CMS-6026-F)............................    0938-AN77
1193        Notification Procedures for Hospital Discharges (CMS-4105-F)..........................    0938-AO41
1194        Identification of Backward Compatible Version of Adopted Standard for E-Prescribing       0938-AO42
            and the Medicare Prescription Drug Program (Version 8.1) (CMS-0018-F).................
1195        Prohibition of Mid-year Benefit Enhancements for Medicare Advantage Organizations         0938-AO54
            Offering Plans in Calendar Year 2007 and Subsequent Calendar Years (CMS-4121-F).......
----------------------------------------------------------------------------------------------------------------


                           Centers for Medicare & Medicaid Services--Completed Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
1196        Requirements for Providers and Suppliers To Establish and Maintain Medicare Enrollment    0938-AH73
            (CMS-6002-F2).........................................................................
1197        Organ Procurement Organization Conditions for Coverage and Recertification (CMS-3064-     0938-AK81
            F) (Completion of a Section 610 Review)...............................................
1198        Fire Safety Requirements for Certain Health Care Facilities; Alcohol-Based Hand           0938-AN36
            Sanitizer Amendment (CMS-3145-F)......................................................
1199        Revisions to the Oversight and Validation Program for Accrediting Organizations           0938-AN62
            Approved for Deeming Authority (CMS-2255-P)...........................................
1200        Physicians' Referrals to Health Care Entities With Which They Have Financial              0938-AN69
            Relationships; E-Prescribing Exceptions (CMS-1303-F)..................................
1201        Home Health Payment System Rate Update for CY 2007 and Deficit Reduction Act of 2005      0938-AN76
            Changes to Medicare Payment for Oxygen Equipment and Capped Rental Durable Medical
            Equipment (CMS-1304-F)................................................................
1202        Inpatient Psychiatric Facility Prospective Payment System--Update for RY 2007 (CMS-       0938-AN82
            1306-F)...............................................................................
1203        Innovations in Fee-for-Service Payment Systems to Improve Quality and Outcomes (CMS-      0938-AN91
            1298-ANPR)............................................................................
1204        Health Care Infrastructure Improvement Program; Loan Program for Qualifying Hospitals     0938-AO03
            Engaged in Cancer-Related Health Care (CMS-1287-F)....................................
1205        Prospective Payment System for Long-Term Care Hospitals RY 2007: Annual Payment Rate      0938-AO06
            Updates (CMS-1485-F)..................................................................
1206        Quality Standards for Genetic Testing (CMS-2121-P)....................................    0938-AO09
1207        Revisions to the Payment Policies of Ambulance Services Under the Fee Schedule for        0938-AO11
            Ambulance Services (CMS-1317-F).......................................................
1208        Hospital Inpatient Prospective Payment Systems and Fiscal Year 2007 Rates: Final          0938-AO12
            Fiscal Year 2007 Wage Indices and Payment Rates After Application of Revised
            Occupational Mix Adjustment (CMS-1488-N)..............................................
1209        Changes to the Hospital Outpatient Prospective Payment System and CY 2007 Payment         0938-AO15
            Rates; and Changes to the ASC Payment System in CY 2007 (CMS-1506-F)..................
1210        Prospective Payment System for Inpatient Rehabilitation Facilities for FY 2007,           0938-AO16
            Certain Provisions Concerning Competitive Acquisition for DMEPOS (CMS-1540-F).........
1211        Part A Premiums for Calendar Year 2007 for the Uninsured Aged and for Certain Disabled    0938-AO18
            Individuals Who Have Exhausted Other Entitlement (CMS-8028-N).........................
1212        Inpatient Hospital Deductible and Hospital and Extended Care Services Coinsurance         0938-AO19
            Amounts for Calendar Year 2007 (CMS-8029-N)...........................................
1213        Fiscal Year 2007 SCHIP Allotments (CMS-2251-N)........................................    0938-AO21
1214        Five-Year Review of Work Relative Value Units Under the Physician Fee Schedule (CMS-      0938-AO22
            1512-PN)..............................................................................
1215        Part B Monthly Actuarial Rates and Premium Rates Beginning January 1, 2007 (CMS-8030-     0938-AO23
            N)....................................................................................
1216        Revisions to Payment Policies under the Physician Fee Schedule and Ambulance Fee          0938-AO24
            Schedule for Calendar Year 2007 (CMS-1321-FC).........................................
1217        Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities--      0938-AO25
            Update for FY 2007 (CMS-1530-N).......................................................
1218        Hospice Wage Index for FY 2007 (CMS-1535-N)...........................................    0938-AO26

[[Page 73205]]

 
1219        State Allotments for Payment of Medicare Part B Premiums for Qualifying Individuals:      0938-AO31
            Fiscal Year 2006 (CMS-2231-F).........................................................
1220        Provider Nomination Provision (CMS-1331-P)............................................    0938-AO33
1221        Extending Sunset Date for the Interim Final Regulation on Mental Health Parity (CMS-      0938-AO36
            4094-F4)..............................................................................
1222        State Health Insurance Assistance Program (SHIP) (CMS-4005-F).........................    0938-AO37
1223        State Children's Health Insurance Program (SCHIP) Redistribution of Unexpended SCHIP      0938-AO38
            Funds From the Appropriation for Fiscal Year 2003 (CMS-2235-NC).......................
1224        Fee Schedule for Payment of Ambulance Services--Update for CY 2007 (CMS-1532-N).......    0938-AO39
1225        Fiscal Year Disproportionate Share Hospital Allotments and Disproportionate Share         0938-AO75
            Hospital Institutions for Mental Disease Limits (CMS-2243-N)..........................
----------------------------------------------------------------------------------------------------------------


                          Administration for Children and Families--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
1226        Developmental Disabilities and Bill of Rights Act.....................................    0970-AC07
1227        Care and Placement of Unaccompanied Alien Children....................................    0970-AC20
1228        Medical Support.......................................................................    0970-AC22
1229        Adoption and Foster Care Analysis and Reporting System................................    0970-AC23
1230        Child Support Provisions of the Deficit Reduction Act.................................    0970-AC24
1231        Privatizing Functions.................................................................    0970-AC25
1232        Limitation on Use of Funds Made Available To Monitor and Combat Trafficking in Persons    0970-AC28
1233        Child Care and Development Fund Error Rate............................................    0970-AC29
1234        Abstinence Education..................................................................    0970-AC30
----------------------------------------------------------------------------------------------------------------


                           Administration for Children and Families--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
1235        Safeguarding Child Support and Expanded Federal Parent Locator Services (FPLS)            0970-AC01
            Information...........................................................................
1236        Cost Allocation Methodology Applicable to the Temporary Assistance for Needy Families     0970-AC15
            Program...............................................................................
1237        Child Care and Development Fund State Match Provisions................................    0970-AC18
1238        Chafee National Youth in Transition Database..........................................    0970-AC21
1239        Head Start Transportation.............................................................    0970-AC26
1240        TANF Work Provisions of the Deficit Reduction Act.....................................    0970-AC27
----------------------------------------------------------------------------------------------------------------


                           Administration for Children and Families--Completed Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
1241        Reasonable Quantitative Standard for Review and Adjustment of Child Support Orders....    0970-AC19
----------------------------------------------------------------------------------------------------------------


[[Page 73206]]

_______________________________________________________________________


Department of Health and Human Services (HHS)       Proposed Rule Stage


Office of the Secretary (OS)



_______________________________________________________________________




985. REVISIONS TO REGULATIONS ADDRESSING THE OIG'S AUTHORITY TO IMPOSE 
CIVIL MONEY PENALTIES AND ASSESSMENTS

Priority: Substantive, Nonsignificant

Legal Authority: 42 USC 1320a-7a; 42 USC 1395mm; 42 USC 1395w-27; 42 
USC 1396b; 42 USC 1396u-2

CFR Citation: 42 CFR 1003

Legal Deadline: None

Abstract: This proposed rule would revise part 1003, addressing the 
Office of Inspector General's authority to propose the imposition of 
civil money penalties and assessments, by reorganizing and simplifying 
existing regulatory text and eliminating obsolete references contained 
in the current regulations. Among the proposed revisions, this rule 
would establish separate subparts within part 1003 for various 
categories of violations; modify the current definition for the term 
``claim''; date various references to managed care organization 
authorities; and clarify the application of section 1140 of the Social 
Security Act with respect to the misuse of certain Departmental 
symbols, emblems, or names through Internet and e-mail communications.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            03/00/07
NPRM Comment Period End         05/00/07

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Joel Jay Schaer, Regulations Officer, Department of 
Health and Human Services, Office of the Secretary, Office of Inspector 
General, 330 Independence Avenue SW., Washington, DC 20201
Phone: 202 619-0089

RIN: 0991-AB03
_______________________________________________________________________


Department of Health and Human Services (HHS)          Final Rule Stage


Office of the Secretary (OS)



_______________________________________________________________________




986. SHARED RISK EXCEPTION TO THE SAFE HARBOR PROVISIONS

Priority: Substantive, Nonsignificant

Legal Authority: 42 USC 1302; 42 USC 1320a-7b; 42 USC 1395hh; PL 104-
191, sec 216(b)

CFR Citation: 42 CFR 1001

Legal Deadline: Final, Statutory, January 1, 1997.

Abstract: This final rule establishes a new statutory exception for 
risk-sharing arrangements under the Federal health care programs' anti-
kickback provisions. The rule sets forth an exception from liability 
for remuneration between an eligible organization and an individual or 
entity providing items or services in accordance with a written 
agreement between these parties. The rule allows remuneration between 
an organization and an individual or entity if a written agreement 
places the individual or entity at ``substantial financial risk'' for 
the cost or utilization of the items or services that the individual or 
entity is obligated to provide.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

ANPRM                           05/23/97                    62 FR 28410
ANPRM Comment Period End        06/09/97
Interim Final Rule              11/19/99                    64 FR 63504
Final Action                    04/00/07

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Joel Jay Schaer, Regulations Officer, Department of 
Health and Human Services, Office of the Secretary, Office of Inspector 
General, 330 Independence Avenue SW., Washington, DC 20201
Phone: 202 619-0089

Related RIN: Related to 0991-AB06
RIN: 0991-AA91
_______________________________________________________________________




987. SAFE HARBOR FOR WAIVER OF BENEFICIARY COINSURANCE AND DEDUCTIBLE 
AMOUNTS FOR A MEDICARE SELECT POLICY

Priority: Substantive, Nonsignificant

Legal Authority: PL 100-93, sec 14(a)

CFR Citation: 42 CFR 1001

Legal Deadline: None

Abstract: This final rule will expand the existing safe harbor for 
certain waivers of beneficiary coinsurance and deductible amounts to 
benefit the policyholders of Medicare SELECT supplemental insurance. 
Specifically, the amended safe harbor will protect waivers of 
coinsurance and deductible amounts under part A or part B of the 
Medicare program owed by beneficiaries covered by a Medicare SELECT 
policy issued in accordance with section 1882(t)(1) of the Social 
Security Act, if the waiver is in accordance with a price reduction 
agreement covering such policyholders between the Medicare SELECT 
issuer and the provider or supplier offering the waiver.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/25/02                    67 FR 60202
NPRM Comment Period End         10/25/02
Final Action                    04/00/07

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Joel Jay Schaer, Regulations Officer, Department of 
Health and Human Services, Office of the Secretary, Office of Inspector 
General, 330 Independence Avenue SW., Washington, DC 20201
Phone: 202 619-0089

RIN: 0991-AB16
_______________________________________________________________________




988. DEBT COLLECTION

Priority: Substantive, Nonsignificant

Legal Authority: 31 USC 3711; 31 CFR 900 to 904

CFR Citation: 45 CFR 30

Legal Deadline: None

Abstract: The Department will amend part 30 of title 45 of the Code of 
Federal Regulations (CFR) to reflect the amendments to the Federal 
Claims Collection Act made by the Debt Collection Improvement Act of 
1996 (DCIA), Public Law 104-134, 110 Stat. 1321 to 1358, as implemented 
by the Department of the Treasury at 31 CFR 900-904. The proposed rule 
will

[[Page 73207]]

prescribe the standards and procedures for the Department's use in the 
administrative collection, offset, compromise, and suspension or 
termination of debts owed to the Department. The proposed rule is 
required in order to bring the Department's claims collection 
provisions in compliance with the Department of the Treasury 
regulations.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            07/13/04                    69 FR 42010
Final Action                    01/00/07

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Jeffrey S. Davis, Associate General Counsel, Department 
of Health and Human Services, Office of the Secretary, HHS Cohen 
Building, Room 4760, 330 Independence Avenue SW., Washington, DC 20201
Phone: 202 619-0150

RIN: 0991-AB18
_______________________________________________________________________




989. SALARY OFFSET

Priority: Substantive, Nonsignificant

Unfunded Mandates: Undetermined

Legal Authority: 5 USC 5514

CFR Citation: 5 CFR 550; 45 CFR 33

Legal Deadline: None

Abstract: The Department will add a new part 33 to title 45 of the Code 
of Federal Regulations (CFR) to implement the salary offset provisions 
of the Debt Collection Improvement Act of 1996 (DCIA), Public Law 104-
134, 110 Stat. 1321 to 1358, codified at 5 U.S.C. 5514, as implemented 
by the Office of Personnel Management at 5 CFR part 550, subpart K. The 
proposed rule is required in order to bring the Department's salary 
offset provisions in compliance with Governmentwide regulations 
published by the Office of Personnel Management.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            07/13/04                    69 FR 42022
Final Action                    01/00/07

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Jeffrey S. Davis, Associate General Counsel, Department 
of Health and Human Services, Office of the Secretary, HHS Cohen 
Building, Room 4760, 330 Independence Avenue SW., Washington, DC 20201
Phone: 202 619-0150

RIN: 0991-AB19
_______________________________________________________________________




990. CLARIFICATION OF TERMS AND APPLICATION OF PROGRAM EXCLUSION 
AUTHORITY FOR SUBMITTING CLAIMS CONTAINING EXCESSIVE CHARGES

Priority: Substantive, Nonsignificant

Legal Authority: Social Security Act, sec 112B(6); Social Security Act, 
sec 112B(6)(A)

CFR Citation: 42 CFR 1001

Legal Deadline: None

Abstract: This rule would amend the Office of Inspector General's 
exclusion regulations at 42 CFR 1001.701, addressing excessive claims, 
by including definitions for the terms ``substantially in excess'' and 
``usual charges,'' and by clarifying the ``good cause'' exception set 
forth in this section.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/15/03                    68 FR 53939
NPRM Comment Period End         11/14/03
Final Action                    04/00/07

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Joel Jay Schaer, Regulations Officer, Department of 
Health and Human Services, Office of the Secretary, Office of Inspector 
General, 330 Independence Avenue SW., Washington, DC 20201
Phone: 202 619-0089

RIN: 0991-AB23
_______________________________________________________________________




991. MEDICARE AND STATE HEALTH CARE PROGRAMS: FRAUD AND ABUSE; SAFE 
HARBOR FOR FEDERALLY QUALIFIED HEALTH CENTERS UNDER THE ANTI-KICKBACK 
STATUTE

Priority: Other Significant

Legal Authority: PL 100-93, sec 14(a); PL 108-173, sec 431

CFR Citation: 42 CFR 1001

Legal Deadline: Final, Statutory, December 8, 2004.

Abstract: This rule will set forth standards for the new anti-kickback 
safe harbor addressing remuneration between federally qualified health 
centers and certain providers where significant community benefit 
exits.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              07/01/05                    70 FR 38081
Interim Final Rule Comment 
Period End                      08/01/05
Final Action                    12/00/06

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Joel Jay Schaer, Regulations Officer, Department of 
Health and Human Services, Office of the Secretary, Office of Inspector 
General, 330 Independence Avenue SW., Washington, DC 20201
Phone: 202 619-0089

Related RIN: Related to 0991-AB06, Related to 0991-AA91
RIN: 0991-AB38

[[Page 73208]]

_______________________________________________________________________


Department of Health and Human Services (HHS)         Long-Term Actions


Office of the Secretary (OS)



_______________________________________________________________________




992. REVISIONS TO THE WAIVER PROVISIONS OF THE OFFICE OF INSPECTOR 
GENERAL'S (OIG) EXCLUSION AUTHORITIES

Priority: Substantive, Nonsignificant

Legal Authority: PL 108-173, sec 949; PL 105-33, sec 4331; Social 
Security Act, sec 1128(c)(3)(b)

CFR Citation: 42 CFR 1001

Legal Deadline: None

Abstract: In accordance with section 949 of the Medicare Prescription 
Drug, Improvement, and Modernization Act of 2003, this rule would 
revise the OIG's exclusion authority to permit any Federal health care 
program to request a waiver of an OIG exclusion imposed under sections 
1128(a)(1), 1128(a)(3), or 1128(a)(4) of the Social Security Act.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Action                     To Be                       Determined

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: Federal

Agency Contact: Joel Jay Schaer, Regulations Officer, Department of 
Health and Human Services, Office of the Secretary, Office of Inspector 
General, 330 Independence Avenue SW., Washington, DC 20201
Phone: 202 619-0089

RIN: 0991-AB33
_______________________________________________________________________


Department of Health and Human Services (HHS)         Completed Actions


Office of the Secretary (OS)



_______________________________________________________________________




993. MEDICARE AND STATE HEALTH CARE PROGRAMS: FRAUD AND ABUSE; SAFE 
HARBOR FOR CERTAIN ELECTRONIC PRESCRIBING ARRANGEMENTS UNDER THE ANTI-
KICKBACK STATUTE

Priority: Other Significant

CFR Citation: 42 CFR 1001

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    08/08/06                    71 FR 45110

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Joel Jay Schaer
Phone: 202 619-0089

RIN: 0991-AB39
_______________________________________________________________________


Department of Health and Human Services (HHS)       Proposed Rule Stage


Substance Abuse and Mental Health Services Administration (SAMHSA)



_______________________________________________________________________




994. REQUIREMENTS GOVERNING THE USE OF SECLUSION AND RESTRAINT IN 
CERTAIN NONMEDICAL COMMUNITY-BASED FACILITIES FOR CHILDREN AND YOUTH

Priority: Other Significant. Major status under 5 USC 801 is 
undetermined.

Legal Authority: PL 106-310

CFR Citation: Not Yet Determined

Legal Deadline: NPRM, Statutory, April 2001.

Abstract: The Secretary is required by statute to publish regulations 
governing States that license nonmedical, community-based residential 
facilities for children and youth. The regulation requires States to 
develop licensing rules and monitoring requirements concerning behavior 
management practice that will ensure compliance; requires States to 
develop and implement such licensing rules and implementation 
requirements within one year; and ensures that States require such 
facilities to have adequate staff, and that the States provide training 
for professional staff.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/00/07

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: State

Federalism:  This action may have federalism implications as defined in 
EO 13132.

Agency Contact: Paolo Del Vecchio, Department of Health and Human 
Services, Substance Abuse and Mental Health Services Administration, 
Room 13-103, Parklawn Building, 5600 Fishers Lane, Rockville, MD 20857
Phone: 301 443-2619

RIN: 0930-AA10
_______________________________________________________________________


Department of Health and Human Services (HHS)          Final Rule Stage


Substance Abuse and Mental Health Services Administration (SAMHSA)



_______________________________________________________________________




995. MANDATORY GUIDELINES FOR THE FEDERAL WORKPLACE DRUG TESTING PROGRAM

Priority: Other Significant

Legal Authority: PL 100-71; 5 USC 7301

CFR Citation: None

Legal Deadline: NPRM, Statutory, December 2003.

Abstract: HHS is proposing to establish scientific and technical 
guidelines for the testing of hair, sweat, and oral fluid specimens in 
addition to urine specimens; scientific and technical guidelines for 
using on-site tests to test urine and oral fluids at the collection 
site; requirements for the certification of instrumented initial test 
facilities; and added standards for collectors, on-site testers, and 
medical review officers.

[[Page 73209]]

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Notice                          04/13/04                    69 FR 19673
Final Action                    06/00/07

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: Federal

Agency Contact: Joseph Denis Faha, Director, DLEA, SAMHSA, Department 
of Health and Human Services, Substance Abuse and Mental Health 
Services Administration, 5600 Fishers Lane, Rockville, MD 20857
Phone: 301 443-7017
Fax: 301 443-1450
Email: [email protected]

RIN: 0930-AA12
_______________________________________________________________________


Department of Health and Human Services (HHS)             Prerule Stage


Centers for Disease Control and Prevention (CDC)



_______________________________________________________________________




996. FOREIGN QUARANTINE REGULATIONS, PROPOSED REVISION OF HHS/CDC ANIMAL 
IMPORTATION REGULATIONS

Priority: Other Significant. Major status under 5 USC 801 is 
undetermined.

Unfunded Mandates: Undetermined

Legal Authority: Not Yet Determined

CFR Citation: 42 CFR 71

Legal Deadline: None

Abstract: The Centers for Disease Control and Prevention (CDC) is 
issuing this Advance Notice of Proposed Rulemaking (ANPRM) to begin the 
process of revising the regulations for importation of dogs, cats and 
other animals into the United States (42 CFR 71.51 and 71.56).
The input received from stakeholders via the ANPRM with the aim of 
improving CDC's ability to prevent importation of communicable 
diseases. The scope of this ANPRM does not include the nonhuman primate 
regulations (42 CFR 71.53).

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

ANPRM                           12/00/06

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: None

Federalism:  Undetermined

Agency Contact: Jennifer Brooks, Department of Health and Human 
Services, Centers for Disease Control and Prevention, National Center 
for Infectious Diseases, 1600 Clifton Road NE., NE E-03, Atlanta, GA 
30333
Phone: 404 639-7048

RIN: 0920-AA14
_______________________________________________________________________




997. AMENDMENTS TO POWERED AIR-PURIFYING RESPIRATOR REQUIREMENTS FOR 
APPROVAL OF RESPIRATORY PROTECTION DEVICES

Priority: Other Significant. Major status under 5 USC 801 is 
undetermined.

Unfunded Mandates: Undetermined

Legal Authority: 28 USC 651; 30 USC 3; 30 USC 7; 30 USC 11; 30 USC 842; 
30 USC 844

CFR Citation: 42 CFR 84

Legal Deadline: None

Abstract: NIOSH plans to modify sections of 42 CFR part 84 concerning 
performance testing and other specifications for the certification of 
powered air-purifying respirators. These respirators are used in a 
variety of workplace applications, including emergency response 
activities.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

ANPRM                           03/00/07

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: None

Federalism:  Undetermined

Agency Contact: Jon Szalajada, Acting Chief, Policy and Standards 
Branch, HHS, CDC, NIOSH, Department of Health and Human Services, 
Centers for Disease Control and Prevention, P.O. Box 18070, 626 
Cochrans Mill Road, Pittsburgh, PA 15236
Phone: 412 386-5200

RIN: 0920-AA16
_______________________________________________________________________




998. AMENDMENTS TO PERFORMANCE REQUIREMENTS FOR CHEMICAL BIOLOGICAL, 
RADIOLOGICAL, AND NUCLEAR (CBRN) APPROVAL OF RESPIRATORY PROTECTION 
DEVICES

Priority: Other Significant. Major status under 5 USC 801 is 
undetermined.

Legal Authority: 29 USC 651; 30 USC 3; 30 USC 5; 30 USC 7; 30 USC 11; 
30 USC 842l; 30 USC 844

CFR Citation: 42 CFR 84

Legal Deadline: None

Abstract: NIOSH plans to modify sections of 42 CFR part 84 concerning 
performance testing and other specifications for the certification of 
closed-circuit, self-contained breathing apparatus, supplied air 
respirators, and combination (supplied air and air purifying capable) 
respirators against CBRN respiratory hazards. These respirators are 
used in emergency response situations.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

ANPRM                           03/00/07

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected:  Businesses

Government Levels Affected: None

Federalism:  Undetermined

Agency Contact: Jon Szalajada, Acting Chief, Policy and Standards 
Branch, HHS, CDC, NIOSH, Department of Health and Human Services, 
Centers for Disease Control and Prevention, P.O. Box 18070, 626 
Cochrans Mill Road, Pittsburgh, PA 15236
Phone: 412 386-5200

RIN: 0920-AA17

[[Page 73210]]

_______________________________________________________________________


Department of Health and Human Services (HHS)       Proposed Rule Stage


Centers for Disease Control and Prevention (CDC)



_______________________________________________________________________




999. AMENDMENTS TO QUALITY ASSURANCE AND ADMINISTRATIVE PROVISION FOR 
APPROVAL OF RESPIRATORY PROTECTIVE DEVICES

Priority: Other Significant. Major status under 5 USC 801 is 
undetermined.

Legal Authority: 29 USC 651 et seq; 30 USC 3; 30 USC 5; 30 USC 7; 30 
USC 811; 30 USC 842(h); 30 USC 844

CFR Citation: 42 CFR 84

Legal Deadline: None

Abstract: NIOSH plans to modify the Administrative/Quality Assurance 
sections of 42 CFR part 84, Approval of Respiratory Protective Devices. 
Areas for potential modification in this module are: 1) Upgrade of 
quality assurance requirements; 2) ability to use private sector 
quality auditors and private sector testing laboratories in the 
approval program; 3) revised approval label requirements; 4) updated 
and restructured fee schedule; and 5) fee retention in the respirator 
program.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/00/06

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected:  Businesses

Government Levels Affected: None

Agency Contact: Jon Szalajada, Acting Chief, Policy and Standards 
Branch, HHS, CDC, NIOSH, Department of Health and Human Services, 
Centers for Disease Control and Prevention, P.O. Box 18070, 626 
Cochrans Mill Road, Pittsburgh, PA 15236
Phone: 412 386-5200

RIN: 0920-AA04
_______________________________________________________________________




1000. AMENDMENTS TO SELF-CONTAINED BREATHING APPARATUS REQUIREMENTS FOR 
APPROVAL OF RESPIRATORY PROTECTIVE DEVICES

Priority: Other Significant

Legal Authority: 29 USC 651 et seq; 30 USC 3; 30 USC 5; 30 USC 7; 30 
USC 811; 30 USC 842; 30 USC 844

CFR Citation: 42 CFR 84

Legal Deadline: None

Abstract: NIOSH plans to modify sections of 42 CFR part 84 concerning 
performance testing and other specifications for the certification of 
closed-circuit, self-contained breathing apparatus. These respiratory 
protective devices are used in emergencies for the protection of miners 
and workers in other industries.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/00/06

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected:  Businesses

Government Levels Affected: None

Agency Contact: Jon Szalajada, Acting Chief, Policy and Standards 
Branch, HHS, CDC, NIOSH, Department of Health and Human Services, 
Centers for Disease Control and Prevention, P.O. Box 18070, 626 
Cochrans Mill Road, Pittsburgh, PA 15236
Phone: 412 386-5200

RIN: 0920-AA10
_______________________________________________________________________




1001. AMENDMENTS TO REQUIREMENTS FOR COAL MINE DUST PERSONAL SAMPLER 
UNITS

Priority: Other Significant. Major status under 5 USC 801 is 
undetermined.

Unfunded Mandates: Undetermined

Legal Authority: Not Yet Determined

CFR Citation: Not Yet Determined

Legal Deadline: None

Abstract: NIOSH and MSHA jointly plan to modify 30 CFR part 74, which 
provides requirements for the approval by NIOSH and MSHA or coal mine 
dust personal sampler units that are worn by miners to determine the 
concentrations of respirable dust in coal mine atmospheres. The 
existing requirements are design-specific for a particular monitoring 
technology that has been available since the 1970's. The amendments 
would establish requirements that would promote the development and 
govern the testing and approval of new coal mine dust sampler designs 
and technology for use in coal mines.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/00/06

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected:  Businesses

Government Levels Affected: None

Federalism:  Undetermined

Agency Contact: John Breslin, Director, Science, Pittsburgh Research 
Laboratory, Department of Health and Human Services, Centers for 
Disease Control and Prevention, 626 Cochrans Mill Road, Pittsburgh, PA 
15236
Phone: 412 386-6873

RIN: 0920-AA18
_______________________________________________________________________


Department of Health and Human Services (HHS)          Final Rule Stage


Centers for Disease Control and Prevention (CDC)



_______________________________________________________________________




1002. CONTROL OF COMMUNICABLE DISEASES, INTERSTATE AND FOREIGN 
QUARANTINE

 Regulatory Plan: This entry is Seq. No. 35 in part II of this issue of 
the Federal Register.

RIN: 0920-AA12
_______________________________________________________________________




1003. PROCEDURES FOR DESIGNATING CLASSES OF EMPLOYEES AS MEMBERS OF THE 
SPECIAL EXPOSURE COHORT UNDER THE ENERGY EMPLOYEES OCCUPATIONAL ILLNESS 
COMPENSATION PROGRAM ACT OF 2000; AMENDMENTS

Priority: Other Significant

Legal Authority: Not Yet Determined

CFR Citation: None

Legal Deadline: None

Abstract: HHS is amending its procedures to consider designating 
classes of employees to be added to the Special Exposure Cohort under 
the Energy Employees Occupational Illness Compensation Program Act of 
2000 (``EEOICPA''), 42 U.S.C. sections 7384-7385. HHS must change these

[[Page 73211]]

procedures to implement amendments to EEOICPA enacted on October 28, 
2004, as part of the Ronald W. Reagan National Defense Authorization 
Act for Fiscal Year 2005, Public Law No. 108-375 (codified as amended 
in scattered sections of 42 U.S.C.).

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              12/22/05                    70 FR 75949
Interim Final Rule Comment 
Period End                      02/21/06
Final Action                    01/00/07

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Larry Elliott, Director, Office of Compensation 
Analysis and Support, Department of Health and Human Services, Centers 
for Disease Control and Prevention, 4676 Columbia Pkwy, MS C-46, 
Cincinnati, OH 45226
Phone: 513 533-6825

RIN: 0920-AA13
_______________________________________________________________________




1004. [bull] INTERSTATE SHIPMENT OF ETIOLOGIC AGENTS

Priority: Other Significant

Legal Authority: Not Yet Determined

CFR Citation: 42 CFR 72

Legal Deadline: None

Abstract: HHS/CDC proposes to rescind part 72 of title 42, Code of 
Federal Regulations, which governs the interstate shipment of etiologic 
agents, because the U.S. Department of Transportation (DOT) already has 
in effect a more comprehensive set of regulations applicable to the 
transport in commerce of infectious substances. DOT harmonizes its 
transport requirements with international standards adopted by the 
United Nations (UN) Committee of Experts on the Transport of Dangerous 
Goods for the classification, packaging, and transport of infectious 
substances. Rescinding the rule will eliminate duplication of the more 
current DOT regulations that cover intrastate and international, as 
well as interstate, transport. HHS/CDC replaced those sections of part 
72 that deal with select biological agents and toxins with a new set of 
regulations found in part 73 of title 42. HHS/CDC anticipates that 
rescission of part 72 will alleviate confusion and reduce the 
regulatory burden with no adverse impact on public health and safety.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              12/00/06

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Janet K Nicholson, Associate Director-Lab Science, 
Department of Health and Human Services, Centers for Disease Control 
and Prevention, Clifton Bldg. 16, Room 5131, Atlanta, GA 30329-4018
Phone: 404 639-3945

RIN: 0920-AA19
_______________________________________________________________________


Department of Health and Human Services (HHS)             Prerule Stage


Food and Drug Administration (FDA)



_______________________________________________________________________




1005. OVER-THE-COUNTER (OTC) DRUG REVIEW--SUNSCREEN PRODUCTS

Priority: Routine and Frequent

Legal Authority: 21 USC 321p; 21 USC 351 to 353; 21 USC 355; 21 USC 
360a; 21 USC 371a; 21 USC 331; 21 USC 360; 21 USC 371

CFR Citation: 21 CFR 201; 21 CFR 310; 21 CFR 330 to 358

Legal Deadline: None

Abstract: The OTC drug review establishes conditions under which OTC 
drugs are considered generally recognized as safe and effective and not 
misbranded. After a final monograph (i.e., final rule) is issued, only 
OTC drugs meeting the conditions of the monograph, or having an 
approved new drug application, may be legally marketed. One action 
addresses sunscreen formulation, labeling, and testing requirements for 
both ultraviolet B (UVB) and ultraviolet A (UVA) radiation protection, 
and the other action addresses combination products containing 
sunscreen and insect repellent ingredients.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM (UVA/UVB)                  12/00/06
ANPRM (Sunscreen and Insect 
Repellent)                      12/00/06

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: Local, State

Federalism:  This action may have federalism implications as defined in 
EO 13132.

Agency Contact: Gerald M. Rachanow, Regulatory Counsel, Division of 
Over-the-Counter Drug Products, Department of Health and Human 
Services, Food and Drug Administration, Center for Drug Evaluation and 
Research, 5600 Fishers Lane, HFD-560, Rockville, MD 20857
Phone: 301 827-2241
Fax: 301 827-2315
Email: [email protected]

Related RIN: Split from 0910-AA01
RIN: 0910-AF43
_______________________________________________________________________




1006. MEDICAL DEVICES; CURRENT GOOD MANUFACTURING PRACTICE (CGMP) FINAL 
RULE; QUALITY SYSTEMS REGULATIONS (SECTION 610 REVIEW)

Priority: Routine and Frequent

Legal Authority: 5 USC 610

CFR Citation: 21 CFR 808; 21 CFR 812; 21 CFR 820

Legal Deadline: None

Abstract: FDA is initiating a review under section 610 of the 
Regulatory Flexibility Act for the regulations in part 820. The purpose 
of this review is to determine if any of the regulations in part 820 
should be continued without change, or should be amended or rescinded, 
to minimize adverse economic impacts on small entities. FDA will 
consider and is soliciting comments on the following: 1) The continued 
need for a regulation in part 820; 2) the nature of complaints or 
comments received concerning a regulation in part 820; 3) the 
complexity of a regulation in part 820; 4) the extent to which a 
regulation in part 820 overlaps, duplicates, or

[[Page 73212]]

conflicts with other Federal, State, or local government rules; and 5) 
the degree to which technology, economic conditions, or other factors 
have changed in the area affected by a regulation in part 820.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Begin Review of Current 
Regulation                      04/01/06
End Review of Current Regulation12/00/06

Regulatory Flexibility Analysis Required: No

Government Levels Affected: Undetermined

Federalism:  Undetermined

Agency Contact: Myrna Hanna, Regulations Staff, Department of Health 
and Human Services, Food and Drug Administration, Center for Devices 
and Radiological Health, HFZ-215, 1350 Piccard Drive, PI50 RM150F, 
Rockville, MD 20850
Phone: 240 276-2347
Fax: 240 276-2352
Email: [email protected]

RIN: 0910-AF71
_______________________________________________________________________




1007. PACKAGE SIZE LIMITATION FOR SODIUM PHOSPHATES ORAL SOLUTION AND 
WARNING AND DIRECTION STATEMENTS FOR ORAL AND RECTAL SODIUM PHOSPHATES 
FOR OVER-THE-COUNTER LAXATIVE USE (SECTION 610 REVIEW)

Priority: Routine and Frequent. Major status under 5 USC 801 is 
undetermined.

Legal Authority: 5 USC 610

CFR Citation: 21 CFR 201.307

Legal Deadline: None

Abstract: Section 201.307 (21 CFR section 201.307) describes a final 
rule to limit the container size for sodium phosphates oral solution 
(dibasic sodium phosphate/monobasic sodium phosphate oral solution) to 
not greater than 90 milliliters (mL) (3 ounces (oz)) when used as an 
over-the-counter (OTC) laxative drug product. FDA limited the container 
size due to reports of deaths associated with an overdosage of sodium 
phosphates when packaged in a larger size container and a larger than 
intended dose was ingested inadvertently. In addition, this final rule 
required warning and direction statements to inform consumers that 
exceeding the recommended dose of oral and rectal sodium phosphates 
products in a 24 hour period could be harmful.
FDA is initiating a review under section 610 of the Regulatory 
Flexibility Act for the regulation in section 201.307. The purpose of 
this review is to determine whether the regulation in section 201.307 
should be continued without change, or whether it should be further 
amended or rescinded, consistent with the stated objectives of 
applicable statutes, to minimize adverse impacts on a substantial 
number of small entities. FDA will consider, and is soliciting comments 
on the following: (1) The continued need for the regulation in section 
201.307; (2) the nature of the complaints or comments received 
concerning the regulation in section 201.307; (3) the complexity of the 
regulation in section 201.307; (4) the extent to which the regulation 
in section 201.307 overlaps, duplicates, or conflicts with other 
Federal, State, or governmental rules; and (5) the degree to which 
technology, economic conditions, or other factors have changed for the 
products still subject to the package size and labeling regulation in 
section 201.307.
The section 610 review will be carried out along with a regulatory 
review under section 5 of Executive Order 12866, which calls for 
agencies to periodically review existing regulations to determine 
whether any should be modified or eliminated so as to make the Agency's 
regulatory program more effective in achieving its goals, less 
burdensome, or in greater alignment with the President's priorities and 
the principles set forth in the Executive order.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Begin Review of Current 
Regulation                      12/00/06
End Review                      12/00/07

Regulatory Flexibility Analysis Required: No

Government Levels Affected: Local, State

Federalism:  This action may have federalism implications as defined in 
EO 13132.

Agency Contact: Walter Ellenberg, Regulatory Project Management 
Officer, Center for Drug Evaluation and Research, Department of Health 
and Human Services, Food and Drug Administration, WO22 RM 5489, HFD-
569, Rockville, MD 20850
Phone: 301 796-0885
Fax: 301 796-9899
Email: [email protected]

RIN: 0910-AF73
_______________________________________________________________________




1008. OVER-THE-COUNTER DRUG PRODUCTS CONTAINING ANALGESIC/ANTIPYRETIC 
ACTIVE INGREDIENTS FOR INTERNAL USE: REQUIRED ALCOHOL WARNING (SECTION 
610 REVIEW)

Priority: Routine and Frequent. Major status under 5 USC 801 is 
undetermined.

Legal Authority: 5 USC 610

CFR Citation: 21 CFR 201.322

Legal Deadline: None

Abstract: Section 201.322 describes a regulation which requires an 
alcohol warning for all over-the-counter (OTC) drug products, labeled 
for adult use, containing internal analgesic/antipyretic active 
ingredients. The required warning statements advise consumers with a 
history of heavy alcohol use to consult a physician for advice about 
the use of OTC internal analgesic/antipyretic drug products. FDA issued 
the final rule after considering comments on the Agency's proposed 
regulation for OTC internal analgesic, antipyretic, and antirheumatic 
drug products: A proposed regulation to establish an alcohol warning; 
recommendations from its Nonprescription Drugs Advisory Committee 
(NDAC) and Arthritis Drugs Advisory Committee (ADAC); and data 
submitted to the agency.
FDA is initiating a review under section 610 of the Regulatory 
Flexibility Act for the regulation in section 201.322. The purpose of 
this review is to determine whether the regulation in section 201.322 
should be continued without change, or whether it should be further 
amended or rescinded, consistent with the stated objectives of 
applicable statutes, to minimize adverse impacts on a substantial 
number of small entities. FDA will consider, and is soliciting comments 
on the following: (1) The continued need for the regulation in section 
201.322; (2) the nature of the complaints or comments received 
concerning the regulation in section 201.322; (3) the

[[Page 73213]]

complexity of the regulation in section 201.322; (4) the extent to 
which the regulation in section 201.322 overlaps, duplicates, or 
conflicts with other Federal, State, or governmental rules; and (5) the 
degree to which technology, economic conditions, or other factors have 
changed for the products still subject to the labeling regulation in 
section 201.322.
The section 610 review will be carried out along with a regulatory 
review under section 5 of Executive Order 12866, which calls for 
agencies to periodically review existing regulations to determine 
whether any should be modified or eliminated so as to make the Agency's 
regulatory program more effective in achieving its goals, less 
burdensome, or in greater alignment with the President's priorities and 
the principles set forth in the Executive order.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Begin Review of Current 
Regulation                      12/00/06
End Review                      12/00/07

Regulatory Flexibility Analysis Required: No

Government Levels Affected: Local, State

Federalism:  This action may have federalism implications as defined in 
EO 13132.

Agency Contact: Walter Ellenberg, Regulatory Project Management 
Officer, Center for Drug Evaluation and Research, Department of Health 
and Human Services, Food and Drug Administration, WO22 RM 5489, HFD-
569, Rockville, MD 20850
Phone: 301 796-0885
Fax: 301 796-9899
Email: [email protected]

RIN: 0910-AF74
_______________________________________________________________________




1009. STATUS OF CERTAIN ADDITIONAL OVER-THE-COUNTER DRUG CATEGORY II AND 
III ACTIVE INGREDIENTS (SECTION 610 REVIEW)

Priority: Routine and Frequent. Major status under 5 USC 801 is 
undetermined.

Legal Authority: 5 USC 610

CFR Citation: 21 CFR 310.545

Legal Deadline: None

Abstract: Section 310.545 (21 CFR 310.545) codifies a final rule that 
was issued stating certain first aid antiseptic, vaginal contraceptive, 
and antimicrobial diaper rash ingredients in over-the-counter (OTC) 
drug products are not generally recognized as safe and effective and 
are misbranded. This rule took into consideration the reports and 
recommendations of various OTC drug advisory review panels and public 
comment on proposed Agency regulations. Based on the absence of 
substantive comments in opposition to the Agency's proposed 
nonmonograph status for various ingredients, as well as the failure of 
interested parties to submit new data or information to FDA, the Agency 
determined that the presence of the subject ingredients in an OTC drug 
products would result in that product not being generally recognized as 
safe and effective and would result in misbranding.
FDA is initiating a review under section 610 of the Regulatory 
Flexibility Act for the regulation in section 310.545. The purpose of 
this review is to determine whether the regulation in section 310.545 
should be continued without change, or whether it should be further 
amended or rescinded, consistent with the stated objectives of 
applicable statutes, to minimize adverse impacts on a substantial 
number of small entities. FDA will consider, and is soliciting comments 
on the following: (1) The continued need for the regulation in section 
310.545; (2) the nature of the complaints or comments received 
concerning the regulation in section 310.545; (3) the complexity of the 
regulations in section 310.545; (4) the extent to which the regulation 
in section 310.545 overlaps, duplicates, or conflicts with other 
Federal, State, or governmental rules; and (5) the degree to which 
technology, economic conditions, or other factors have changed for the 
products still subject to the regulation in section 310.545.
The section 610 review will be carried out along with a regulatory 
review under section 5 of Executive Order 12866, which calls for 
agencies to periodically review existing regulations to determine 
whether any should be modified or eliminated so as to make the Agency's 
regulatory program more effective in achieving its goals, less 
burdensome, or in greater alignment with the President's priorities and 
the principles set forth in the Executive order.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Begin Review of Current 
Regulation                      12/00/06
End Review                      12/00/07

Regulatory Flexibility Analysis Required: No

Government Levels Affected: Local, State

Federalism:  This action may have federalism implications as defined in 
EO 13132.

Agency Contact: Walter Ellenberg, Regulatory Project Management 
Officer, Center for Drug Evaluation and Research, Department of Health 
and Human Services, Food and Drug Administration, WO22 RM 5489, HFD-
569, Rockville, MD 20850
Phone: 301 796-0885
Fax: 301 796-9899
Email: [email protected]

RIN: 0910-AF75
_______________________________________________________________________




1010. MEDICAL DEVICES: CLASSIFICATION/RECLASSIFICATION; RESTRICTED 
DEVICES; ANALYTE SPECIFIC REAGENTS (SECTION 610 REVIEW)

Priority: Other Significant

Legal Authority: 21 USC 351; 21 USC 352; 21 USC 360j

CFR Citation: 21 CFR 809.10; 21 CFR 809.30

Legal Deadline: None

Abstract: FDA is initiating a review under section 610 of the 
Regulatory Flexibility Act for two regulations in part 809. The purpose 
of this review is to determine if 21 CFR 809.10 and 809.30 should be 
continued without change, or should be amended or rescinded, to 
minimize adverse economic impact on small entities. FDA is soliciting 
and will consider comments on the following: 1) The continued need for 
21 CFR 809.10 and 809.30; 2) the nature of complaints or comments 
received concerning 21 CFR 809.10 and 809.30; 3) the complexity of 21 
CFR 809.10 and 809.30; 4) the extent to which 21 CFR 809.10 and 809.30 
overlap, duplicate, or conflict with other Federal, State, or local 
government rules; and 5) the degree to which technology economic 
conditions or other factors have changed in the area affected by 21 CFR 
809.10 and 809.30.

[[Page 73214]]

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Begin Review of Current 
Regulation                      12/00/06
End Review of Current Regulation11/00/07

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Myrna Hanna, Regulations Staff, Department of Health 
and Human Services, Food and Drug Administration, Center for Devices 
and Radiological Health, HFZ-215, 1350 Piccard Drive, PI50 RM150F, 
Rockville, MD 20850
Phone: 240 276-2347
Fax: 240 276-2352
Email: [email protected]

RIN: 0910-AF76
_______________________________________________________________________




1011. AMENDED ECONOMIC IMPACT ANALYSIS OF FINAL RULE ON USER LABELING ON 
NATURAL RUBBER-CONTAINING MEDICAL DEVICE (SECTION 610 REVIEW)

Priority: Other Significant. Major status under 5 USC 801 is 
undetermined.

Legal Authority: 21 USC 321; 21 USC 331; 21 USC 351; 21 USC 352; 21 USC 
357; 21 USC 360i; 21 USC 360j; 21 USC 371; 21 USC 374

CFR Citation: 21 CFR 801.437

Legal Deadline: Other, Statutory, September 30, 2007, Planned Section 
610 Review.

Abstract: FDA is initiating a review of the regulations in part 801 
under section 610 of the Regulatory Flexibility Act. The purpose of 
this review is to determine, consistent with stated objectives and 
applicable statutes, whether the regulations in part 801 should be 
continued without change, amended, or rescinded in order to minimize 
any significant economic impact on a substantial number of small 
entities. FDA will consider and is soliciting comments on the 
following: 1) The continued need for the regulation; 2) the nature of 
complaints or comments received concerning the regulation; 3) the 
complexity of the regulation; 4) the extent to which a regulation in 
part 801 overlaps, duplicates, or conflicts with other Federal rules, 
and to the extent feasible, with State and local government rules; and 
5) the degree to which technology, economic conditions, or other 
factors have changed in the area affected by the regulation.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Action                    09/30/97                    62 FR 51021
Final Action Effective          09/30/98
End Review of Current Regulation12/00/06

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Myrna Hanna, Regulations Staff, Department of Health 
and Human Services, Food and Drug Administration, Center for Devices 
and Radiological Health, HFZ-215, 1350 Piccard Drive, PI50 RM150F, 
Rockville, MD 20850
Phone: 240 276-2347
Fax: 240 276-2352
Email: [email protected]

RIN: 0910-AF77
_______________________________________________________________________




1012. FINANCIAL DISCLOSURE BY CLINICAL INVESTIGATORS (SECTION 610 
REVIEW)

Priority: Other Significant. Major status under 5 USC 801 is 
undetermined.

Legal Authority: 21 USC 321; 21 USC 331; 21 USC 351; 21 USC 352; 21 USC 
353; 21 USC 355; 21 USC 356; 21 USC 357; 21 USC 360; 21 USC 360c to 
360j; 21 USC 371; 21 USC 372; 21 USC 373; 21 USC 374; 21 USC 375; 21 
USC 376; 21 USC 379; 42 USC 262

CFR Citation: 21 CFR 54; 21 CFR 312.53; 21 CFR 312.57; 21 CFR 312.64; 
21 CFR 314.50; 21 CFR 314.60; 21 CFR 314.94; 21 CFR 314.200; 21 CFR 
314.300; 21 CFR 320.36; 21 CFR 330.10; 21 CFR 601.2; 21 CFR 807.31; 21 
CFR 807.87; 21 CFR 807.100; 21 CFR 812.43; 21 CFR 812.110; 21 CFR 
812.140; 21 CFR 814.20; 21 CFR 814.42; 21 CFR 814.112; 21 CFR 860.123

Legal Deadline: Other, Statutory, February 2, 2006, Planned Section 610 
Review.

Abstract: FDA is undertaking a review of 21 CFR sections 54, 312.53, 
312.47, 312.64, 314.50, 314.60, 314.94, 314.200, 314.300, 320.36, 
330.10, 601.2, 807.31, 807.87, 807.100, 812.43, 812.110, 812.140, 
814.20, 814.42, 814.112 and 860.123 under section 610 of the Regulatory 
Flexibility Act. The purpose of this review is to determine whether the 
regulations in sections 54, 312.53, 312.47, 312.64, 314.50, 314.60, 
314.94, 314.200, 314.300, 320.36, 330.10, 601.2, 807.31, 807.87, 
807.100, 812.43, 812.110, 812.140, 814.20, 814.42, 814.112 and 860.123 
should be continued without change, or whether they should be amended 
or rescinded, consistent with the stated objectives of applicable 
statues, to minimize adverse impacts on a substantial number of small 
entities. FDA will consider, and is soliciting comments on, the 
following: (1) The continued need for the regulations in sections 54, 
312.53, 312.47, 312.64, 314.50, 314.60, 314.94, 314.200, 314.300, 
320.36, 330.10, 601.2, 807.31, 807.87, 807.100, 812.43, 812.110, 
812.140, 814.20, 814.42, 814.112 and 860.123; (2) the nature of 
complaints or comments received concerning the regulations in sections 
54, 312.53, 312.47, 312.64, 314.50, 314.60, 314.94, 314.200, 314.300, 
320.36, 330.10, 601.2, 807.31, 807.87, 807.100, 812.43, 812.110, 
812.140, 814.20, 814.42, 814.112 and 860.123; (3) the complexity of the 
regulations in sections 54, 312.53, 312.47, 312.64, 314.50, 314.60, 
314.94, 314.200, 314.300, 320.36, 330.10, 601.2, 807.31, 807.87, 
807.100, 812.43, 812.110, 812.140, 814.20, 814.42, 814.112 and 860.123; 
(4) the extent to which the regulations in sections 54, 312.53, 312.47, 
312.64, 314.50, 314.60, 314.94, 314.200, 314.300, 320.36, 330.10, 
601.2, 807.31, 807.87, 807.100, 812.43, 812.110, 812.140, 814.20, 
814.42, 814.112 and 860.123 overlap, duplicate, or conflict with other 
regulations with other Federal, State, or governmental rules, and (5) 
the degree to which technology, economic conditions, or other factors 
have changed in the area affected by the regulations in sections 54, 
312.53, 312.47, 312.64, 314.50, 314.60, 314.94, 314.200, 314.300, 
320.36, 330.10, 601.2, 807.31, 807.87, 807.100, 812.43, 812.110, 
812.140, 814.20, 814.42, 814.112 and 860.123.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Begin Review of Current 
Regulation                      12/00/06
End Review of Current Regulation12/00/07

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

[[Page 73215]]

Agency Contact: Howard P. Muller, Office of Regulatory Policy, 
Department of Health and Human Services, Food and Drug Administration, 
Center for Drug Evaluation and Research, 5515 Security Lane, Suite 1101 
(HFD-7), Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562
Email: [email protected]

Stephen M. Ripley, Team Leader, Department of Health and Human 
Services, Food and Drug Administration, Center for Biologics Evaluation 
and Research, Suite 200N, HFM-17, 1401 Rockville Pike, Rockville, MD 
20852-1448
Phone: 301 827-6210
Fax: 301 827-9434

Elisa D. Harvey, Director, Office of Device Evaluation, Department of 
Health and Human Services, Food and Drug Administration, Center for 
Devices and Radiological Health, 1350 Piccard Drive (HFZ-215), Corp Rm 
130F, Rockville, MD 20850
Phone: 301 594-1190
Fax: 301 594-3076
Email: [email protected]

RIN: 0910-AF79
_______________________________________________________________________




1013. BEVERAGES: BOTTLED WATER (SECTION 610 REVIEW)

Priority: Substantive, Nonsignificant. Major status under 5 USC 801 is 
undetermined.

Unfunded Mandates: Undetermined

Legal Authority: 21 USC 321; 21 USC 341; 21 USC 343; 21 USC 343-1; 21 
USC 348; 21 USC 349; 21 USC 371; 21 USC 379e

CFR Citation: 21 CFR 165.110

Legal Deadline: Other, Statutory, November 13, 2005, Planned Section 
610 Review.

Abstract: Section 165.110 (21 CFR 165.110) describes requirements for 
identity and quality standards for bottled water. FDA is undertaking a 
review of section 165.110 under section 610 of the Regulatory 
Flexibility Act. The purpose of this review is to determine whether the 
regulations in section 165.110 should be continued without change, or 
whether they should be amended or rescinded, consistent with the stated 
objectives of applicable statutes, to minimize any significant economic 
impact on a substantial number of small entities. FDA will consider, 
and is soliciting comments on, the following: (1) The continued need 
for the regulations in section 165.110; (2) the nature of complaints or 
comments received concerning the regulations in section 165.110; (3) 
the complexity of the regulations; (4) the extent to which the 
regulations in section 165.110 overlap, duplicate, or conflict with 
other Federal rules, and to the extent feasible, with State, or 
governmental rules; and (5) the degree to which technology, economic 
conditions, or other factors have changed in the area affected by the 
regulations in section 165.110.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Begin Review                    03/00/07
End Review                      12/00/07

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Federalism:  Undetermined

Agency Contact: Richard A. Williams, Director, Division of Social 
Sciences, ORP, CFSAN, Department of Health and Human Services, Food and 
Drug Administration, HFS-725, Center for Food Safety and Applied 
Nutrition, 5100 Paint Branch Parkway, College Park, MD 20740
Phone: 301 436-1989
Fax: 301 436-2626
Email: [email protected]

RIN: 0910-AF80
_______________________________________________________________________




1014. FOOD LABELING; NUTRIENT CONTENT CLAIMS: DEFINITION FOR ``HIGH 
POTENCY'' AND DEFINITION OF ``ANTIOXIDANT'' FOR USE IN NUTRIENT CONTENT 
CLAIMS FOR DIETARY SUPPLEMENTS AND CONVENTIONAL FOODS (SECTION 610 
REVIEW)

Priority: Other Significant. Major status under 5 USC 801 is 
undetermined.

Legal Authority: 15 USC 1453; 15 USC 1454; 15 USC 1455; 21 USC 321; 21 
USC 331; 21 USC 342; 21 USC 343; 21 USC 348; 21 USC 371

CFR Citation: 21 CFR 101.54; 21 CFR 101.60

Legal Deadline: Other, Statutory, September 23, 2007, Deadline for 
610(c) Review.

Abstract: Section 101.54 (21 CFR 101.54) describes the requirements for 
when the terms ``high potency'' and ``antioxidant'' may be used on the 
label or in the labeling of foods, including dietary supplements. 
Section 101.60 (21 CFR 101.60) describes the requirements for when the 
terms ``low calorie'' or ``reduced calorie'' may be used on the label 
or in the labeling of such foods. FDA is undertaking a review of 
sections 101.54 and 101.60 under section 610 of the Regulatory 
Flexibility Act. The purpose of this review is to determine whether the 
regulations should be continued without change, or whether they should 
be amended or rescinded, consistent with the stated objectives of 
applicable statutes, to minimize any significant economic impact on a 
substantial number of small entities. FDA will consider, and is 
soliciting comments on, the following: (1) The continued need for the 
regulations in sections 101.54 and 101.60; (2) the nature of complaints 
or comments received concerning the regulations; (3) the complexity of 
the regulations; (4) the extent to which the regulations in sections 
101.54 and 101.60 overlap, duplicate, or conflict with other Federal 
rules, and to the extent feasible, with State, or governmental rules; 
and (5) the degree to which technology, economic conditions, or other 
factors have changed in the area affected by the regulations in 
sections 101.54 and 101.60.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Begin Review                    12/00/06
End Review                      09/00/07

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Federal, Local, State, Tribal

Federalism:  This action may have federalism implications as defined in 
EO 13132.

Agency Contact: Richard A. Williams, Director, Division of Social 
Sciences, ORP, CFSAN, Department of Health and Human Services, Food and 
Drug Administration, HFS-725, Center for Food Safety and Applied 
Nutrition, 5100 Paint Branch Parkway, College Park, MD 20740
Phone: 301 436-1989
Fax: 301 436-2626
Email: [email protected]

RIN: 0910-AF83

[[Page 73216]]

_______________________________________________________________________


Department of Health and Human Services (HHS)       Proposed Rule Stage


Food and Drug Administration (FDA)



_______________________________________________________________________




1015. MEDICAL DEVICES; ANESTHESIOLOGY DEVICES; PROPOSED RECLASSIFICATION 
OF PRESSURE REGULATORS FOR USE WITH MEDICAL OXYGEN AND SEPARATE 
CLASSIFICATION OF OXYGEN CONSERVING DEVICES

Priority: Routine and Frequent

Legal Authority: 21 USC 351; 21 USC 352; 21 USC 360c; 21 USC 360i; 21 
USC 371

CFR Citation: 21 CFR 868.2700; 21 CFR 868.2750

Legal Deadline: None

Abstract: The Food and Drug Administration (FDA) is proposing to 
reclassify pressure regulators for use with medical oxygen from class I 
to class II, establish a separate classification for oxygen conserving 
devices, and establish a special control for these devices to address 
problems of fire and explosion associated with use of these devices. 
The special control would be a guidance document that includes 
standardized testing, performance, and labeling guidance for industry. 
Devices that meet the special control would be exempt from the 
premarket notification requirements of the Federal Food, Drug, and 
Cosmetic Act (the Act). The agency believes it is taking a least 
burdensome approach for industry. The requirements of the proposed rule 
would be phased-in to minimize the cost of complying with the special 
control. FDA seeks to reclassify these devices under section 513(e)(1) 
of the act (21 U.S.C. 360c(e)(1)).

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/00/06

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Federalism:  Undetermined

Agency Contact: Myrna Hanna, Regulations Staff, Department of Health 
and Human Services, Food and Drug Administration, Center for Devices 
and Radiological Health, HFZ-215, 1350 Piccard Drive, PI50 RM150F, 
Rockville, MD 20850
Phone: 240 276-2347
Fax: 240 276-2352
Email: [email protected]

RIN: 0910-AC30
_______________________________________________________________________




1016. ELECTRONIC SUBMISSION OF DATA FROM STUDIES EVALUATING HUMAN DRUGS 
AND BIOLOGICS

 Regulatory Plan: This entry is Seq. No. 36 in part II of this issue of 
the Federal Register.

RIN: 0910-AC52
_______________________________________________________________________




1017. REPORTING INFORMATION REGARDING FALSIFICATION OF DATA

Priority: Other Significant. Major status under 5 USC 801 is 
undetermined.

Unfunded Mandates: Undetermined

Legal Authority: 21 USC 321; 21 USC 341 to 343; 21 USC 348; 21 USC 349; 
21 USC 351; 21 USC 352; 21 USC 355; 21 USC 360b; 21 USC 360c; 21 USC 
360e; 21 USC 360i to 360k; 21 USC 361; 21 USC 371; 21 USC 379e; 42 USC 
262

CFR Citation: 21 CFR 16.1; 21 CFR 58.11; 21 CFR 58.12; 21 CFR 71.1; 21 
CFR 101.69; 21 CFR 170.101; 21 CFR 171.1; 21 CFR 190.6; 21 CFR 312.3; 
21 CFR 312.56; 21 CFR 511.1; 21 CFR 571.1; 21 CFR 812.46

Legal Deadline: None

Abstract: The proposed rule would require sponsors to promptly report 
any information indicating that any person has or may have engaged in 
the falsification of data in the course of proposing, designing, 
performing, recording, supervising, or reviewing research, or in 
reporting research results.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/00/06

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: None

Agency Contact: Brian L. Pendleton, Regulatory Counsel, Department of 
Health and Human Services, Food and Drug Administration, Center for 
Drug Evaluation and Research, 5515 Security Lane, Suite 1101 (HFD-7), 
Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562
Email: [email protected]

Related RIN: Previously reported as 0910-AC02
RIN: 0910-AC59
_______________________________________________________________________




1018. CONTENT AND FORMAT OF LABELING FOR HUMAN PRESCRIPTION DRUGS AND 
BIOLOGICS; REQUIREMENTS FOR PREGNANCY AND LACTATION LABELING

 Regulatory Plan: This entry is Seq. No. 37 in part II of this issue of 
the Federal Register.

RIN: 0910-AF11
_______________________________________________________________________




1019. CHARGING FOR INVESTIGATIONAL DRUGS

Priority: Substantive, Nonsignificant. Major status under 5 USC 801 is 
undetermined.

Legal Authority: 21 USC 321; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 
21 USC 371; 42 USC 262

CFR Citation: 21 CFR 312.7; 21 CFR 312.8

Legal Deadline: None

Abstract: The proposed rule would amend FDA's investigational new drug 
regulation concerning charging for investigational drugs. The proposed 
rule would clarify the circumstances in which charging for an 
investigational drug in a clinical trial is appropriate, set forth 
criteria for charging for an investigational drug for the different 
types of treatment uses to be described in the Agency's proposed rule 
on expanded access to investigational drugs for treatment use, and 
clarify what costs can be recovered for an investigational drug. The 
proposed rule is intended to permit charging for a broader range of 
investigational uses than is explicitly permitted in current 
regulations.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/00/06

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected:  Businesses

Government Levels Affected: None

Agency Contact: Christine F. Rogers, Regulatory Counsel, Department of 
Health and Human Services, Food and Drug Administration, Center for 
Drug Evaluation and Research, 5515 Security Lane, Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562
Email: [email protected]

RIN: 0910-AF13

[[Page 73217]]

_______________________________________________________________________




1020. EXPANDED ACCESS TO INVESTIGATIONAL DRUGS FOR TREATMENT USE

 Regulatory Plan: This entry is Seq. No. 38 in part II of this issue of 
the Federal Register.

RIN: 0910-AF14
_______________________________________________________________________




1021. BLOOD INITIATIVE--REQUIREMENTS FOR HUMAN BLOOD AND BLOOD 
COMPONENTS INTENDED FOR TRANSFUSION OR FOR FURTHER MANUFACTURING USE

Priority: Other Significant

Legal Authority: 21 USC 321; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 
21 USC 360; 21 USC 360c to 360e; 21 USC 360h to 360j; 21 USC 360l; 21 
USC 371; 21 USC 372; 21 USC 374; 21 USC 381; 21 USC 383; 42 USC 216; 42 
USC 243; 42 USC 262; 42 USC 263; 42 USC 263a; 42 USC 264; 42 USC 271

CFR Citation: 21 CFR 606; 21 CFR 610; 21 CFR 630; 21 CFR 640; 21 CFR 
660; 21 CFR 820; 21 CFR 1270

Legal Deadline: None

Abstract: The Food and Drug Administration (FDA) is proposing to amend 
the biologics regulations, particularly those related to blood donor 
eligibility, by removing, revising, or updating specific regulations 
applicable to blood, blood components, source plasma, and source 
leukocytes to be more consistent with current practices and to remove 
unnecessary or outdated requirements. This action is based on FDA's 
comprehensive review of the biologics regulations. It is also based on 
reports by the U.S. House of Representatives Committee on Government 
Reform and Oversight Subcommittee on House Resources and 
Intergovernmental Relations, the General Accounting Office, and the 
Institute of Medicine, and on public comments. These actions are 
intended to help ensure the continued safety of the Nation's blood 
supply.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            01/00/07

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Kathleen G. Swisher, Supervisory Regulatory Counsel, 
Department of Health and Human Services, Food and Drug Administration, 
Center for Biologics Evaluation and Research, HFM-17, 1401 Rockville 
Pike, Rockville, MD 20852-1448
Phone: 301 827-6210
Fax: 301 827-9434

Related RIN: Split from 0910-AB26
RIN: 0910-AF25
_______________________________________________________________________




1022. OVER-THE-COUNTER (OTC) DRUG REVIEW--INTERNAL ANALGESIC PRODUCTS

Priority: Routine and Frequent

Legal Authority: 21 USC 321p; 21 USC 351 to 353; 21 USC 355; 21 USC 
360a; 21USC 371a; 21 USC 331; 21 USC 360; 21 USC 360gg to 360ss; 21 USC 
371; 21 USC 374; 21 USC 379e; 42 USC 216; 42 USC 241; 42 USC 262; 42 
USC 264

CFR Citation: 21 CFR 201; 21 CFR 310; 21 CFR 330 to 358

Legal Deadline: None

Abstract: The OTC drug review establishes conditions under which OTC 
drugs are considered generally recognized as safe and effective and not 
misbranded. After a final monograph (i.e., final rule) is issued, only 
OTC drugs meeting the conditions of the monograph, or having an 
approved new drug application, may be legally marketed. One action 
addresses labeling intended to better inform consumers of potential 
risks associated with these products. The second action addresses 
products marketed for children under 2 years old and weight- and age-
based dosing for children's products. The third action addresses 
combination products containing the analgesic acetaminophen or aspirin 
and sodium bicarbonate used as an antacid ingredient. The fourth action 
addresses products labeled to relieve upset stomach associated with 
overindulgence in food and drink and to relieve symptoms associated 
with a hangover. The Stevens Johnson and Cardiovascular Warnings 
Documents address new proposed product warnings.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM (Amendment) (Required 
Warnings and Other Labeling)    12/00/06
NPRM (Amendment) (Pediatric)    03/00/07
NPRM (Amendment) (Combinations 
with Sodium Bicarbonate)        06/00/07
NPRM (Amendment) (Cardiovascular 
Warnings)                       06/00/07
NPRM (Amendment) 
(Overindulgence/ Hangover)      10/00/07
NPRM (Amendment) (Stevens 
Johnson Warnings)               10/00/07
Final Action (Internal 
Analgesics)                     10/00/07

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: Local, State

Federalism:  This action may have federalism implications as defined in 
EO 13132.

Agency Contact: Gerald M. Rachanow, Regulatory Counsel, Division of 
Over-the-Counter Drug Products, Department of Health and Human 
Services, Food and Drug Administration, Center for Drug Evaluation and 
Research, 5600 Fishers Lane, HFD-560, Rockville, MD 20857
Phone: 301 827-2241
Fax: 301 827-2315
Email: [email protected]

Related RIN: Split from 0910-AA01
RIN: 0910-AF36
_______________________________________________________________________




1023. OVER-THE-COUNTER (OTC) DRUG REVIEW--LABELING OF DRUG PRODUCTS FOR 
OTC HUMAN USE

Priority: Routine and Frequent

Legal Authority: 21 USC 321p; 21 USC 351 to 353; 21 USC 355; 21 USC 
360a; 21USC 371a; 21 USC 331; 21 USC 360; 21 USC 371; 21 USC 358; 21 
USC 360gg to 360ss; 21 USC 374; 21 USC 379e; 42 USC 216; 42 USC 241; 42 
USC 262; 42 USC 264

CFR Citation: 21 CFR 201; 21 CFR 310; 21 CFR 330 to 358

Legal Deadline: None

Abstract: The OTC drug review establishes conditions under which OTC 
drugs are considered generally recognized as safe and effective and not 
misbranded. After a final monograph (i.e., final rule) is issued, only 
OTC drugs meeting the conditions of the monograph, or having an 
approved new

[[Page 73218]]

drug application, may be legally marketed. This action addresses 
labeling for convenience (small) size OTC drug packages.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM (Convenience Sizes)        12/00/06

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: Local, State

Federalism:  This action may have federalism implications as defined in 
EO 13132.

Agency Contact: Gerald M. Rachanow, Regulatory Counsel, Division of 
Over-the-Counter Drug Products, Department of Health and Human 
Services, Food and Drug Administration, Center for Drug Evaluation and 
Research, 5600 Fishers Lane, HFD-560, Rockville, MD 20857
Phone: 301 827-2241
Fax: 301 827-2315
Email: [email protected]

Related RIN: Split from 0910-AA01
RIN: 0910-AF37
_______________________________________________________________________




1024. OVER-THE-COUNTER (OTC) DRUG REVIEW--OPHTHALMIC PRODUCTS

Priority: Routine and Frequent

Legal Authority: 21 USC 321p; 21 USC 351 to 353; 21 USC 355; 21 USC 
360a; 21 USC 371a; 21 USC 331; 21 USC 360; 21 USC 371

CFR Citation: 21 CFR 201; 21 CFR 310; 21 CFR 330 to 358

Legal Deadline: None

Abstract: The OTC drug review establishes conditions under which OTC 
drugs are considered generally recognized as safe and effective and not 
misbranded. After a final monograph (i.e., final rule) is issued, only 
OTC drugs meeting the conditions of the monograph, or having an 
approved new drug application, may be legally marketed. This action 
addresses emergency first aid eyewash products.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM (Amendment) (Emergency 
First Aid Eyewashes)            06/00/07

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: Local, State

Federalism:  This action may have federalism implications as defined in 
EO 13132.

Agency Contact: Gerald M. Rachanow, Regulatory Counsel, Division of 
Over-the-Counter Drug Products, Department of Health and Human 
Services, Food and Drug Administration, Center for Drug Evaluation and 
Research, 5600 Fishers Lane, HFD-560, Rockville, MD 20857
Phone: 301 827-2241
Fax: 301 827-2315
Email: [email protected]

Related RIN: Split from 0910-AA01
RIN: 0910-AF39
_______________________________________________________________________




1025. OVER-THE-COUNTER (OTC) DRUG REVIEW--ORAL HEALTH CARE PRODUCTS

Priority: Routine and Frequent

Legal Authority: 21 USC 321p; 21 USC 351 to 353; 21 USC 355; 21 USC 
360a; 21 USC 371a; 21 USC 331; 21 USC 360; 21 USC 371

CFR Citation: 21 CFR 201; 21 CFR 310; 21 CFR 330 to 358

Legal Deadline: None

Abstract: The OTC drug review establishes conditions under which OTC 
drugs are considered generally recognized as safe and effective and not 
misbranded. After a final monograph (i.e., final rule) is issued, only 
OTC drugs meeting the conditions of the monograph, or having an 
approved new drug application, may be legally marketed. This action 
will address oral health care products used to reduce or prevent dental 
plaque and gingivitis.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM (Plaque Gingivitis)        05/00/07

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: Local, State

Federalism:  This action may have federalism implications as defined in 
EO 13132.

Agency Contact: Gerald M. Rachanow, Regulatory Counsel, Division of 
Over-the-Counter Drug Products, Department of Health and Human 
Services, Food and Drug Administration, Center for Drug Evaluation and 
Research, 5600 Fishers Lane, HFD-560, Rockville, MD 20857
Phone: 301 827-2241
Fax: 301 827-2315
Email: [email protected]

Related RIN: Split from 0910-AA01
RIN: 0910-AF40
_______________________________________________________________________




1026. OVER-THE-COUNTER (OTC) DRUG REVIEW--SKIN BLEACHING PRODUCTS

Priority: Routine and Frequent

Legal Authority: 21 USC 321p; 21 USC 351 to 353; 21 USC 355; 21 USC 
360; 21 USC 360a; 21 USC 371; 21 USC 371a; 21 USC 331

CFR Citation: 21 CFR 201; 21 CFR 310; 21 CFR 330 to 358

Legal Deadline: None

Abstract: The OTC drug review establishes conditions under which OTC 
drugs are considered generally recognized as safe and effective and not 
misbranded. After a final monograph (i.e., final rule) is issued, only 
OTC drugs meeting the conditions of the monograph, or having an 
approved new drug application, may be legally marketed. This action 
addresses skin bleaching drug products containing hydroquinone.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            08/29/06                    71 FR 51146
NPRM Comment Period End         12/27/06
Final Action                     To Be                       Determined

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: Local, State

Federalism:  This action may have federalism implications as defined in 
EO 13132.

Agency Contact: Gerald M. Rachanow, Regulatory Counsel, Division of 
Over-the-Counter Drug Products, Department of Health and Human 
Services, Food and Drug Administration, Center for Drug Evaluation and 
Research, 5600 Fishers Lane, HFD-560, Rockville, MD 20857

[[Page 73219]]

Phone: 301 827-2241
Fax: 301 827-2315
Email: [email protected]

RIN: 0910-AF53
_______________________________________________________________________




1027. USE OF MATERIALS DERIVED FROM CATTLE IN MEDICAL PRODUCTS INTENDED 
FOR USE IN HUMANS AND DRUGS INTENDED FOR USE IN RUMINANTS

Priority: Other Significant

Legal Authority: 21 USC 321; 21 USC 331; 21 USC 351; 21 USC 352; 21 USC 
355; 21 USC 360b; 21 USC 360f; 21 USC 360i; 21 USC 371; 21 USC 374; 21 
USC 381; 42 USC 262; 42 USC 264; 42 USC 271

CFR Citation: 21 CFR 211.116; 21 CFR 226.60; 21 CFR 300.200; 21 CFR 
500.200; 21 CFR 530; 21 CFR 600.16; 21 CFR 895.102; 21 CFR 1271.465; 21 
CFR 1271.470

Legal Deadline: None

Abstract: The regulation would prohibit the use of certain cattle 
material in the manufacture of medical products for humans and drugs 
for ruminants, and would require recordkeeping for products containing 
or manufactured with cattle materials to enable monitoring and 
enforcement of the prohibitions. The rule would prohibit the same 
cattle material that is prohibited in the previous FDA IFR that applies 
to foods and cosmetics. These include certain high risk tissues (e.g., 
brain, skull, eyes, spinal cord, trigeminal ganglia, parts of the 
vertebral column, and dorsal root ganglia) from cattle 30 months and 
older, tonsils and the distal ileum of cattle of any age, mechanically 
separated beef, material from nonambulatory disabled cattle, and 
material from cattle not inspected and passed for human consumption. 
The prohibitions would apply only to materials derived from animals 
slaughtered after the effective dates of the rules. The prohibitions 
would not apply to tallow that met a specified purity standard. The 
rule would provide criteria for deviations from the requirements based 
on a showing of safety or appropriate benefit to risk ratio.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/00/06

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Eric Flamm, Senior Policy Advisor, Office of Policy, 
Department of Health and Human Services, Food and Drug Administration, 
Office of the Commissioner, 5600 Fishers Lane, Room 14C-17, HF-23, 
Rockville, MD 20857
Phone: 301 827-0591
Fax: 301 827-4774
Email: [email protected]

Related RIN: Merged with 0910-AF55
RIN: 0910-AF54
_______________________________________________________________________




1028. OVER-THE-COUNTER (OTC) DRUG REVIEW--STIMULANT DRUG PRODUCTS

Priority: Routine and Frequent

Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 
355; 21 USC 360; 21 USC 360a; 21 USC 371; 21 USC 371a

CFR Citation: 21 CFR 201; 21 CFR 310; 21 CFR 330 to 358

Legal Deadline: None

Abstract: The OTC drug review establishes conditions under which OTC 
drugs are considered generally recognized as safe and effective and not 
misbranded. After a final monograph (i.e., final rule) is issued, only 
OTC drugs meeting the conditions of the monograph, or having an 
approved new drug application, may be legally marketed. This action 
addresses the use of stimulant active ingredients to relieve symptoms 
associated with a hangover.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM (Amendment) (Hangover)     06/00/07

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: Local, State

Federalism:  This action may have federalism implications as defined in 
EO 13132.

Agency Contact: Gerald M. Rachanow, Regulatory Counsel, Division of 
Over-the-Counter Drug Products, Department of Health and Human 
Services, Food and Drug Administration, Center for Drug Evaluation and 
Research, 5600 Fishers Lane, HFD-560, Rockville, MD 20857
Phone: 301 827-2241
Fax: 301 827-2315
Email: [email protected]

RIN: 0910-AF56
_______________________________________________________________________




1029. LABEL REQUIREMENT FOR FOOD THAT HAS BEEN REFUSED ADMISSION INTO 
THE UNITED STATES

 Regulatory Plan: This entry is Seq. No. 39 in part II of this issue of 
the Federal Register.

RIN: 0910-AF61
_______________________________________________________________________




1030. OVER-THE-COUNTER ANTIDIARRHEAL DRUG PRODUCTS

Priority: Routine and Frequent. Major status under 5 USC 801 is 
undetermined.

Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 
355; 21 USC 360; 21 USC 360a; 21 USC 371; 21 USC 371a

CFR Citation: 21 CFR 201; 21 CFR 310; 21 CFR 330 to 358

Legal Deadline: None

Abstract: The OTC drug review establishes conditions under which OTC 
drugs are considered generally recognized as safe and effective and not 
misbranded. After a final monograph (i.e., final rule) is issued, only 
OTC drugs meeting the conditions of the monograph, or having an 
approved new drug application, may be legally marketed. This action 
addresses products containing antidiarrheal drug ingredients.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/00/07

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: Local, State

Federalism:  This action may have federalism implications as defined in 
EO 13132.

Agency Contact: Walter Ellenberg, Regulatory Project Management 
Officer, Center for Drug Evaluation and Research, Department of Health 
and Human Services, Food and Drug

[[Page 73220]]

Administration, WO22 RM 5489, HFD-569, Rockville, MD 20850
Phone: 301 796-0885
Fax: 301 796-9899
Email: [email protected]

Related RIN: Related to 0910-AC82
RIN: 0910-AF63
_______________________________________________________________________




1031. INDEX OF LEGALLY MARKETED UNAPPROVED NEW ANIMAL DRUGS FOR MINOR 
SPECIES

Priority: Other Significant

Legal Authority: 21 USC 360 ccc-1

CFR Citation: 21 CFR 516

Legal Deadline: NPRM, Statutory, February 2, 2006.
Final, Statutory, August 2, 2007.

Abstract: This proposed rule is being issued in response to the Minor 
Use and Minor Species (MUMS) Animal Health Act of 2004. The proposed 
rule implements section 572 of the MUMS Act which provides for a public 
index listing of legally-marketed unapproved new animal drugs for minor 
species of animals (species other than cattle, horses, swine, chickens, 
turkeys, dogs, and cats). The drugs in this index will only be 
indicated for use in non-food minor species or for use in early non-
food life stages to food-producing minor species. This proposed rule, 
will, among other things, specify the procedures for requesting 
eligibility for indexing and for requesting addition to the index as 
well as the reporting requirements for index holders. This rule will 
also describe the criteria requestors will use for assembling a 
qualified expert panel to evaluate for FDA the target animal safety and 
effectiveness of a new animal drug proposed for indexing.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            08/22/06                    71 FR 48840
NPRM Comment Period Extended    10/02/06                    71 FR 57892
NPRM Comment Period End         12/20/06
Final Action                    08/00/07

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Andrew J. Beaulieu, Director, Office of Minor Use and 
Minor Species Animal Drug Development, Department of Health and Human 
Services, Food and Drug Administration, Center for Veterinary Medicine, 
7519 Standish Place, Room 180, HFV-50, MPN-4, Rockville, MD 20855
Phone: 240 276-9090
Fax: 240 276-9001
Email: [email protected]

RIN: 0910-AF67
_______________________________________________________________________




1032. OVER-THE-COUNTER (OTC) DRUG REVIEW--POISON TREATMENT DRUG PRODUCTS

Priority: Routine and Frequent. Major status under 5 USC 801 is 
undetermined.

Legal Authority: 21 USC 321p; 21 USC 351 to 353; 21 USC 355; 21 USC 
360a; 21 USC 371a; 21 USC 331; 21 USC 360; 21 USC 371

CFR Citation: 21 CFR 201; 21 CFR 310; 21 CFR 330 to 358

Legal Deadline: None

Abstract: The OTC drug review establishes conditions under which OTC 
drugs are considered generally recognized as safe and effective and not 
misbranded. After a final monograph (i.e., final rule) is issued, only 
OTC drugs meeting the conditions of the monograph, or having an 
approved new drug application, may be legally marketed. This action 
addresses the ingredient ipecac.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM (IPECAC)                   05/00/07

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: Local, State

Federalism:  This action may have federalism implications as defined in 
EO 13132.

Agency Contact: Walter Ellenberg, Regulatory Project Management 
Officer, Center for Drug Evaluation and Research, Department of Health 
and Human Services, Food and Drug Administration, WO22 RM 5489, HFD-
569, Rockville, MD 20850
Phone: 301 796-0885
Fax: 301 796-9899
Email: [email protected]

RIN: 0910-AF68
_______________________________________________________________________




1033. OVER-THE-COUNTER (OTC) DRUG REVIEW--TOPICAL ANTIMICROBIAL DRUG 
PRODUCTS

Priority: Routine and Frequent

Legal Authority: 21 USC 321p; 21 USC 351 to 353; 21 USC 355; 21 USC 
360a; 21 USC 371a; 21 USC 331; 21 USC 360; 21 USC 371

CFR Citation: 21 CFR 201; 21 CFR 310; 21 CFR 330 to 358

Legal Deadline: None

Abstract: The OTC drug review establishes conditions under which OTC 
drugs are considered generally recognized as safe and effective and not 
misbranded. After a final monograph (i.e., final rule) is issued, only 
OTC drugs meeting the conditions of the monograph, or having an 
approved new drug application, may be legally marketed. These actions 
address the consumer healthcare, food handlers and healthcare 
antiseptic products.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM (Consumer Products)        10/00/07
NPRM (Food Handlers)            10/00/07
NPRM (Healthcare Antiseptics)   10/00/07

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: Local, State

Federalism:  This action may have federalism implications as defined in 
EO 13132.

Agency Contact: Walter Ellenberg, Regulatory Project Management 
Officer, Center for Drug Evaluation and Research, Department of Health 
and Human Services, Food and Drug Administration, WO22 RM 5489, HFD-
569, Rockville, MD 20850
Phone: 301 796-0885
Fax: 301 796-9899
Email: [email protected]

RIN: 0910-AF69
_______________________________________________________________________




1034. OVER-THE-COUNTER (OTC) DRUG REVIEW--URINARY ANALGESIC DRUG 
PRODUCTS

Priority: Routine and Frequent. Major status under 5 USC 801 is 
undetermined.

Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 
355;

[[Page 73221]]

21 USC 360; 21 USC 360a; 21 USC 371; 21 USC 371a

CFR Citation: 21 CFR 201; 21 CFR 310; 21 CFR 330 to 358

Legal Deadline: None

Abstract: The OTC drug review establishes conditions under which OTC 
drugs are considered generally recognized as safe and effective and not 
misbranded. After a final monograph (i.e., final rule) is issued, only 
OTC drugs meeting the conditions of the monograph, or having an 
approved new drug application, may be legally marketed. This action 
addresses the products used for urinary pain relief.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM (Urinary Analgesic)        08/00/07

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: Local, State

Federalism:  This action may have federalism implications as defined in 
EO 13132.

Agency Contact: Walter Ellenberg, Regulatory Project Management 
Officer, Center for Drug Evaluation and Research, Department of Health 
and Human Services, Food and Drug Administration, WO22 RM 5489, HFD-
569, Rockville, MD 20850
Phone: 301 796-0885
Fax: 301 796-9899
Email: [email protected]

RIN: 0910-AF70
_______________________________________________________________________




1035. IMPORT TOLERANCES FOR ANIMAL DRUGS

Priority: Substantive, Nonsignificant

Legal Authority: 21 USC 360b(a)(6); 21 USC 371

CFR Citation: Not Yet Determined

Legal Deadline: None

Abstract: FDA plans to publish a proposed rule related to the 
implementation of the import tolerances provision of the Animal Drug 
Availability Act of 1996 (ADAA). The ADAA authorizes FDA to establish 
drug residue tolerances (import tolerances) for imported food products 
of animal origin for drugs that are used in other countries, but that 
are unapproved new animal drugs in the United States. Food products of 
animal origin that are in compliance with the import tolerances will 
not be considered adulterated under the Federal Food, Drug, and 
Cosmetic Act (the Act) and may be imported into the United States.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            03/00/07

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: George Kenneth Haibel, Veterinary Medical Officer, 
Department of Health and Human Services, Food and Drug Administration, 
7519 Standish Place, Rm. 169, MPN-4, HFV-6, Rockville, MD 20855
Phone: 240 276-9019
Fax: 240 276-9101
Email: [email protected]

RIN: 0910-AF78
_______________________________________________________________________




1036. CURRENT GOOD MANUFACTURING PRACTICE FOR COMBINATION PRODUCTS

Priority: Other Significant. Major status under 5 USC 801 is 
undetermined.

Legal Authority: 21 USC 321; 21 USC 331; 21 USC 351; 21 USC 352; 21 USC 
353; 21 USC 355; 21 USC 360; 21 USC 360c to 360f; 21 USC 360h to 360j; 
21 USC 360l; 21 USC 360hh to 360ss; 21 USC 360aaa to 360bbb; 21 USC 
371a; 21 USC 372 to 374; 21 USC 379e; 21 USC 381; 21 USC 394; 42 USC 
216; 42 USC 262; 42 USC 263a; 42 USC 264; 42 USC 271

CFR Citation: 21 CFR 4, subchapter A

Legal Deadline: None

Abstract: The proposed rule would clarify and streamline the current 
good manufacturing practice (cGMP) requirements for combination 
products (combinations of a drug, device, and/or biological product). 
The proposed rule would provide a flexible, quality management 
regulatory framework that recognizes that, in most instances, for 
combination products, a properly implemented quality system program 
under one set of medical product cGMP regulations will meet the 
requirements of another set (e.g., application of cGMPs for finished 
pharmaceuticals in 21 CFR 210/211 will generally meet the requirements 
of the device quality system regulations in 21 CFR 820). It would allow 
manufacturers the flexibility to select either the cGMP or quality 
system regulation to apply for the manufacture of their combination 
product, provided that their system incorporates select, key provisions 
from the regulations pertaining to the other part of their combination 
product. It would avoid the necessity to fully implement both sets of 
cGMP regulations when manufacturing combination products. The proposed 
rule is intended to ensure consistency and appropriateness in the 
regulation of combination products.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            03/00/07

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: James S. Cohen, Senior Counsel, Department of Health 
and Human Services, Food and Drug Administration, Office of Combination 
Products, 15800 Crabbs Branch Way, Suite 200 (HFG-3), Rockville, MD 
20855
Phone: 301 427-1934
Fax: 301 427-1935
Email: [email protected]

RIN: 0910-AF81
_______________________________________________________________________




1037. POSTMARKET SAFETY REPORTING FOR COMBINATION PRODUCTS

Priority: Other Significant

Legal Authority: 21 USC 321; 21 USC 331; 21 USC 351; 21 USC 352; 21 USC 
353; 21 USC 355; 21 USC 360; 21 USC 360c to 360f; 21 USC 360h to 360j; 
21 USC 360l; 21 USC 360hh to 360ss; 21 USC 360aaa to 360bbb; 21 USC 
371a; 21 USC 372 to 374; 21 USC 379e; 21 USC 381; 21 USC 394; 42 USC 
216; 42 USC 262; 42 USC 263a; 42 USC 264; 42 USC 271

CFR Citation: 21 CFR 4, subchapter B

Legal Deadline: None

Abstract: The proposed rule would clarify the postmarket safety 
reporting requirements for combination products (combinations of a 
drug, device, and/or biological product). The proposed rule

[[Page 73222]]

would provide a framework for the reporting of adverse events for 
combination products. The proposed rule would clarify the circumstances 
in which following one set of postmarket safety reporting regulations 
generally would meet the requirements of another set, and the 
circumstances in which these requirements would be supplemented with 
specific reporting provisions applicable to the other constituent part 
of the combination product. The regulation would ensure the consistency 
and appropriateness of postmarket safety reporting for combination 
products while avoiding the need for duplicative reporting 
requirements.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            03/00/07

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Leigh Hayes, Regulatory Counsel, Department of Health 
and Human Services, Food and Drug Administration, Office of Combination 
Products, 15800 Crabbs Branch Way, Suite 200 (HFG-3), Rockville, MD 
20855
Phone: 301 427-1934
Fax: 301 427-1935
Email: [email protected]

RIN: 0910-AF82
_______________________________________________________________________




1038. [bull] REVISIONS TO THE REQUIREMENTS APPLICABLE TO BLOOD, BLOOD 
COMPONENTS, AND SOURCE PLASMA

Priority: Routine and Frequent

Legal Authority: 21 USC 321; 21 USC 331; 21 USC 351; 21 USC 352; 21 USC 
353; 21 USC 355; 21 USC 360; 21 USC 360c; 21 USC 360d; 21 USC 360h; 21 
USC 360i; 21 USC 360j; 21 USC 371; 21 USC 372; 21 USC 374; 21 USC 381; 
21 USC 393; 42 USC 216; 42 USC 262; 42 USC 263; 42 USC 263a; 42 USC 
264; 42 USC 271

CFR Citation: 21 CFR 606.3; 21 CFR 607.65; 21 CFR 640

Legal Deadline: None

Abstract: FDA is issuing this rulemaking to amend the biologics 
regulations by removing, revising, or updating specific regulations 
applicable to blood, blood components, and Source Plasma to be more 
consistent with current practices in the blood industry and to remove 
unnecessary or outdated requirements. Some examples of the amendments 
include revisions to the dating period for Platelets, Red Blood Cells 
Deglycerolized, and Red Blood Cells Frozen; storage temperatures for 
blood; and pooling and pH level of Platelets. FDA is also removing two 
obsolete regulations.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM - Companion to Direct Final 
Rule                            03/00/07
Direct Final Rule               03/00/07

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Stephen M. Ripley, Team Leader, Department of Health 
and Human Services, Food and Drug Administration, Center for Biologics 
Evaluation and Research, Suite 200N, HFM-17, 1401 Rockville Pike, 
Rockville, MD 20852-1448
Phone: 301 827-6210
Fax: 301 827-9434

RIN: 0910-AF84
_______________________________________________________________________




1039. [bull] REVISION OF THE REQUIREMENTS FOR LIVE VACCINE PROCESSING

Priority: Other Significant

Legal Authority: 21 USC 321; 21 USC 351 to 353; 21 USC 355; 21 USC 360; 
21 USC 360i; 21 USC 371; 21 USC 374; 42 USC 216; 42 USC 262; 42 USC 
263; 42 USC 263a; 42 USC 264; 42 USC 300aa-25

CFR Citation: 21 CFR 600.11

Legal Deadline: None

Abstract: This rulemaking is being issued to provide options to the 
existing requirement for processing live vaccines. FDA is amending the 
regulations due to advances in facility, system, and equipment design, 
and in sterilization technologies that will allow live vaccine 
processing to be performed in multiproduct manufacturing areas. We are 
amending this regulation to permit manufacturers greater flexibility in 
the use of their buildings and equipment for processing live vaccines 
when appropriate controls exist and have been demonstrated to be 
effective in preventing cross contamination of other products and 
areas. We are taking this action as part of our continuing effort to 
reduce the burden of unnecessary regulations and to revise outdated 
regulations without diminishing public health protection.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM--Companion to Direct Final 
Rule                            05/00/07
Direct Final Rule               05/00/07

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Nathaniel L. Geary, Consumer Safety Officer, Department 
of Health and Human Services, Food and Drug Administration, Center for 
Biologics Evaulation and Research, 1401 Rockville Pike, HFM-17, 
Rockville, MD 20852-1448
Phone: 301 827-6210
Fax: 301 827-9434
Email: [email protected]

RIN: 0910-AF85
_______________________________________________________________________




1040. [bull] MEDICAL DEVICE REPORTING; ELECTRONIC SUBMISSION 
REQUIREMENTS

 Regulatory Plan: This entry is Seq. No. 40 in part II of this issue of 
the Federal Register.

RIN: 0910-AF86
_______________________________________________________________________




1041. [bull] LASER PRODUCTS; AMENDMENT TO PERFORMANCE STANDARD

Priority: Substantive, Nonsignificant

Legal Authority: 21 USC 360kk

CFR Citation: 21 CFR 1020; 21 CFR 1040

Legal Deadline: None

Abstract: FDA is proposing to amend the performance standard for laser 
products to achieve harmonization between the current standard 
International Electrotechnical Commission (IEC) standard for laser 
products and medical laser products. The proposed amendment is intended 
to update FDA's performance standard to reflect advancements in 
technology. The proposal would adopt portions of an IEC standard (to 
achieve harmonization and reflect current science), include an 
alternative mechanism for providing certification and identification, 
address novelty laser

[[Page 73223]]

products, and clarify the military exemption for laser products.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/00/07

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected:  Businesses

Government Levels Affected: None

Agency Contact: Myrna Hanna, Regulations Staff, Department of Health 
and Human Services, Food and Drug Administration, Center for Devices 
and Radiological Health, HFZ-215, 1350 Piccard Drive, PI50 RM150F, 
Rockville, MD 20850
Phone: 240 276-2347
Fax: 240 276-2352
Email: [email protected]

RIN: 0910-AF87
_______________________________________________________________________




1042. [bull] ELECTRONIC REGISTRATION AND LISTING FOR DEVICES

 Regulatory Plan: This entry is Seq. No. 41 in part II of this issue of 
the Federal Register.

RIN: 0910-AF88
_______________________________________________________________________




1043. [bull] REGULATIONS ON FIXED-COMBINATION DRUG PRODUCTS

Priority: Substantive, Nonsignificant

Legal Authority: 21 USC 331; 21 USC 351; 21 USC 352; 21 USC 355; 21 USC 
371

CFR Citation: 21 CFR 300.50

Legal Deadline: None

Abstract: The proposed rule would amend FDA regulations on fixed-
combination prescription and OTC drugs. The current regulations 
require, among other things, that the sponsor of a fixed-combination 
drug demonstrate that each of the components makes a contribution to 
the drug's claimed effects. The proposed rule would create a single set 
of regulations for prescription and OTC combination drugs and codify 
existing policy on what kinds of studies are needed to show that the 
combination drug requirements are met, and it would clarify application 
of FDA's combination policy to certain natural source drugs and certain 
synthetic drugs. The regulation would also establish circumstances 
under which the agency might waive the combination drug requirements 
for a particular drug. The proposed rule will also address the issue of 
co-packaging.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/00/07

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Brian L. Pendleton, Regulatory Counsel, Department of 
Health and Human Services, Food and Drug Administration, Center for 
Drug Evaluation and Research, 5515 Security Lane, Suite 1101 (HFD-7), 
Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562
Email: [email protected]

RIN: 0910-AF89
_______________________________________________________________________




1044. [bull] USE OF OZONE-DEPLETING SUBSTANCES; REMOVAL OF ESSENTIAL USE 
DESIGNATIONS [EPINEPHRINE]

Priority: Other Significant. Major status under 5 USC 801 is 
undetermined.

Legal Authority: 21 USC 321; 21 USC 331; 21 USC 335; 21 USC 342; 21 USC 
346a; 21 USC 348; 21 USC 355; 42 USC 7671 et seq

CFR Citation: 21 CFR 1.25 (revision); 40 CFR 82.4; 40 CFR 82.64; 40 CFR 
82.66

Legal Deadline: None

Abstract: Medical products using chlorofluorocarbons (CFCs) and other 
ozone-depleting substances may only be legally marketed if they are 
listed in 21 CFR 2.125 as ``essential uses.'' This proposed rule would 
remove the essential use designations after a specified date for 
metered-dose inhalers (MDIs) containing epinephrine. Under the 
provisions of this proposed rule these MDIs would have to be removed 
from the market. This proposed rule is consistent with obligations 
under the Clean Air Act and the Montreal Protocol on Substances that 
Deplete the Ozone Layer.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            07/00/07

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Wayne H. Mitchell, Regulatory Counsel, Office of 
Regulatory Policy, Department of Health and Human Services, Food and 
Drug Administration, Center for Drug Evaluation and Research, 5600 
Fishers Lane, HFD-7, Rockville, MD 20857
Phone: 301 594-2041
Fax: 301 827-0951
Email: [email protected]

RIN: 0910-AF92
_______________________________________________________________________




1045. [bull] USE OF OZONE-DEPLETING SUBSTANCES; REMOVAL OF ESSENTIAL USE 
DESIGNATIONS [FLUNISOLIDE, TRIAMCINOLONE, METAPROTERENOL, PIRBUTEROL, 
ALBUTEROL AND IPRATROPIUM IN COMBINATION, CROMOLYN, AND NEDOCROMIL].

Priority: Other Significant. Major under 5 USC 801.

Legal Authority: 21 USC 321; 21 USC 331; 21 USC 335; 21 USC 342; 21 USC 
346a; 21 USC 348; 21 USC 355; 42 USC 7671 et seq

CFR Citation: 21 CFR 1.25 (revision); 40 CFR 82.4; 40 CFR 82.64; 40 CFR 
82.66

Legal Deadline: None

Abstract: Medical products using chlorofluorocarbons (CFCs) and other 
ozone-depleting substances may only be legally marketed if they are 
listed in 21 CFR 2.125 as ``essential uses.'' This proposed rule would 
remove the essential use designations after a specified date for 
metered-dose inhalers (MDIs) containing flunisolide, triamcinolone, 
metaproterenol, pirbuterol, albuterol and ipratropium in combination, 
cromolyn, and nedocromil. Under the provisions of this proposed rule 
these MDIs would have to be removed from the market. This proposed rule 
is consistent with obligations under the Clean Air Act and the Montreal 
Protocol on Substances that Deplete the Ozone Layer.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            05/00/07

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Wayne H. Mitchell, Regulatory Counsel, Office of 
Regulatory Policy, Department of

[[Page 73224]]

Health and Human Services, Food and Drug Administration, Center for 
Drug Evaluation and Research, 5600 Fishers Lane, HFD-7, Rockville, MD 
20857
Phone: 301 594-2041
Fax: 301 827-0951
Email: [email protected]

RIN: 0910-AF93
_______________________________________________________________________


Department of Health and Human Services (HHS)          Final Rule Stage


Food and Drug Administration (FDA)



_______________________________________________________________________




1046. FOREIGN AND DOMESTIC ESTABLISHMENT REGISTRATION AND LISTING 
REQUIREMENTS FOR HUMAN DRUGS, INCLUDING DRUGS THAT ARE REGULATED UNDER A 
BIOLOGICS LICENSE APPLICATION, AND ANIMAL DRUGS

Priority: Other Significant

Legal Authority: 21 USC 321; 21 USC 331; 21 USC 351; 21 USC 352; 21 USC 
355; 21 USC 360; 21 USC 360b; 21 USC 371; 21 USC 374; 42 USC 262; 42 
USC 264; 42 USC 271

CFR Citation: 21 CFR 20; 21 CFR 201; 21 CFR 207; 21 CFR 314; 21 CFR 
330; 21 CFR 514; 21 CFR 515; 21 CFR 601; 21 CFR 607; 21 CFR 610; 21 CFR 
1271

Legal Deadline: None

Abstract: The rule will reorganize, consolidate, clarify, and modify 
current regulations at 21 CFR part 207 concerning who must register 
establishments and list human drugs, certain biological drugs, and 
animal drugs. These regulations contain information on when, how, and 
where to register drug establishments and list drugs, and what 
information must be submitted for initial registration and listing and 
for changes to registration and listing. The rule will require that 
this information be submitted via the Internet into the FDA 
registration and listing database, instead of the current requirement 
to submit the information to FDA on paper forms. The rule will also 
require that the NDC number appear on certain drug labels. In addition, 
FDA will assign the NDC number to newly listed drugs and take other 
steps to minimize the use of inaccurate NDC numbers on drug labels.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            08/29/06                    71 FR 51276
NPRM Comment Period End         11/27/06
Final Action                    09/00/07

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected:  Businesses

Government Levels Affected: None

Agency Contact: Howard P. Muller, Office of Regulatory Policy, 
Department of Health and Human Services, Food and Drug Administration, 
Center for Drug Evaluation and Research, 5515 Security Lane, Suite 1101 
(HFD-7), Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562
Email: [email protected]

RIN: 0910-AA49
_______________________________________________________________________




1047. SAFETY REPORTING REQUIREMENTS FOR HUMAN DRUG AND BIOLOGICAL 
PRODUCTS

Priority: Other Significant. Major status under 5 USC 801 is 
undetermined.

Unfunded Mandates: Undetermined

Legal Authority: 42 USC 216; 42 USC 241; 42 USC 242a; 42 USC 262; 42 
USC 263; 42 USC 263a to 263-n; 42 USC 264; 42 USC 300aa; 21 USC 321; 21 
USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 360; 21 USC 360b to 
360j; 21 USC 361a; 21 USC 371; 21 USC 374; 21 USC 375; 21 USC 379e; 21 
USC 381

CFR Citation: 21 CFR 310; 21 CFR 312; 21 CFR 314; 21 CFR 320; 21 CFR 
600; 21 CFR 601; 21 CFR 606

Legal Deadline: None

Abstract: This regulation is one component of the Secretary's 
initiative to reduce medical errors. The final rule would amend the 
expedited and periodic safety reporting regulations for human drugs and 
biological products to revise certain definitions and reporting formats 
as recommended by the International Conference on Harmonisation and to 
define new terms; to add to or revise current reporting requirements; 
to revise certain reporting time frames; and propose other revisions to 
these regulations to enhance the quality of safety reports received by 
FDA.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            03/14/03                    68 FR 12406
NPRM Comment Period Extended    06/18/03
NPRM Comment Period End         07/14/03
NPRM Comment Period Extension 
End                             10/14/03
Comment Review End              04/00/07
Final Action                    09/00/07

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: Undetermined

Agency Contact: Carol Drew, Regulatory Counsel, Department of Health 
and Human Services, Food and Drug Administration, Center for Drug 
Evaluation and Research, 5515 Security Lane, Suite 1101 (HFD-7), 
Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562

RIN: 0910-AA97
_______________________________________________________________________




1048. APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG; COMPLETE 
RESPONSE LETTER; AMENDMENTS TO UNAPPROVED APPLICATIONS

Priority: Substantive, Nonsignificant. Major status under 5 USC 801 is 
undetermined.

Legal Authority: 21 USC 321; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 
21 USC 371; 21 USC 374; 21 USC 379e

CFR Citation: 21 CFR 312; 21 CFR 314

Legal Deadline: None

Abstract: The rule would amend the regulations on marketing approval of 
new drugs to discontinue the use of approvable and not approvable 
letters when taking action on a marketing application and instead use 
complete response letters. The rule would also amend the regulations on 
extension of the review clock because of amendments to applications.

[[Page 73225]]

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            07/20/04                    69 FR 43357
Final Action                    04/00/07

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Brian L. Pendleton, Regulatory Counsel, Department of 
Health and Human Services, Food and Drug Administration, Center for 
Drug Evaluation and Research, 5515 Security Lane, Suite 1101 (HFD-7), 
Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562
Email: [email protected]

RIN: 0910-AB34
_______________________________________________________________________




1049. CGMPS FOR BLOOD AND BLOOD COMPONENTS: NOTIFICATION OF CONSIGNEES 
AND TRANSFUSION RECIPIENTS RECEIVING BLOOD AND BLOOD COMPONENTS AT 
INCREASED RISK OF TRANSMITTING HCV INFECTION (LOOKBACK)

Priority: Other Significant

Legal Authority: 21 USC 321; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 
21 USC 360; 21 USC 360c; 21 USC 360d; 21 USC 360h to 360j; 21 USC 371; 
21 USC 374; 42 USC 216; 42 USC 262; 42 USC 263 to 42 USC 263a; 42 USC 
264; 21 USC 372; 21 USC 381

CFR Citation: 21 CFR 606; 21 CFR 610

Legal Deadline: None

Abstract: This rulemaking is one of a number of actions being taken to 
amend the biologics regulations to remove, revise, or update the 
regulations applicable to blood, blood components, and blood 
derivatives. These actions are based on FDA's comprehensive review of 
the biologics regulations and on reports by the U.S. House of 
Representatives Committee on Government Reform and Oversight's, 
Subcommittee on House Resources and Intergovernmental Relations, the 
General Accounting Office, and the Institute of Medicine, as well as on 
public comments. In this rulemaking, FDA will amend the biologics 
regulations to require that blood establishments prepare and follow 
written procedures for appropriate action when it is determined that 
blood and blood components pose an increased risk for transmitting 
hepatitis C virus (HCV) infection because they have been collected from 
a donor who, at a later date, tested reactive for evidence of HCV. The 
HIV lookback regulations will be amended for consistency.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            11/16/00                    65 FR 69377
NPRM Comment Period End         02/14/01
Final Action                    02/00/07

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Stephen M. Ripley, Team Leader, Department of Health 
and Human Services, Food and Drug Administration, Center for Biologics 
Evaluation and Research, Suite 200N, HFM-17, 1401 Rockville Pike, 
Rockville, MD 20852-1448
Phone: 301 827-6210
Fax: 301 827-9434

Related RIN: Related to 0910-AB26
RIN: 0910-AB76
_______________________________________________________________________




1050. CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKING, OR 
HOLDING DIETARY INGREDIENTS AND DIETARY SUPPLEMENTS

 Regulatory Plan: This entry is Seq. No. 42 in part II of this issue of 
the Federal Register.

RIN: 0910-AB88
_______________________________________________________________________




1051. ADDITIONAL SAFEGUARDS FOR CHILDREN IN CLINICAL INVESTIGATIONS

Priority: Other Significant. Major status under 5 USC 801 is 
undetermined.

Unfunded Mandates: Undetermined

Legal Authority: 21 USC 321; 21 USC 343; 21 USC 346; 21 USC 346a; 21 
USC 348; 21 USC 350a; 21 USC 350b; 21 USC 351 to 353; 21 USC 355; 21 
USC 360; 21 USC 360c to 360f; 21 USC 360h to 360j; 21 USC 371; 21 USC 
379e; 21 USC 381; 41 USC 216; 41 USC 241; 41 USC 262; 41 USC 263b to 
263n

CFR Citation: 21 CFR 50; 21 CFR 56

Legal Deadline: None

Abstract: The final rule will finalize the interim rule that published 
in April 2001, providing additional protections for children involved 
as subjects in clinical investigations of FDA-regulated products, as 
required by the Children's Health Act of 2000.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Rule                    04/24/01                    66 FR 20589
Final Action                    04/00/07

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Carol Drew, Regulatory Counsel, Department of Health 
and Human Services, Food and Drug Administration, Center for Drug 
Evaluation and Research, 5515 Security Lane, Suite 1101 (HFD-7), 
Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562

RIN: 0910-AC07
_______________________________________________________________________




1052. PREVENTION OF SALMONELLA ENTERITIDIS IN SHELL EGGS

Priority: Economically Significant. Major under 5 USC 801.

Unfunded Mandates: This action may affect the private sector under PL 
104-4.

Legal Authority: 21 USC 321; 21 USC 342; 21 USC 371; 21 USC 381; 21 USC 
393; 42 USC 243; 42 USC 264; 42 USC 271; . . .

CFR Citation: 21 CFR 16; 21 CFR 116; 21 CFR 118

Legal Deadline: None

Abstract: In July 1999, the Food and Drug Administration (FDA) and the 
Food Safety Inspection Service (FSIS) committed to developing an action 
plan to address the presence of salmonella enteritidis (SE) in shell 
eggs and egg products using a farm-to-table approach. FDA and FSIS held 
a public meeting on August 26, 1999, to obtain stakeholder input on the 
draft goals, as well as to further develop the objectives and action 
items for the action plan. The Egg Safety Action Plan was announced on 
December 11, 1999. The goal of the Action Plan is to reduce egg-related 
SE illnesses by 50 percent by 2005 and eliminate egg-related SE 
illnesses by 2010.
The Egg Safety Action Plan consists of eight objectives covering all 
stages of

[[Page 73226]]

the farm-to-table continuum as well as support functions. On March 30, 
2000 (Columbus, OH), April 6, 2000 (Sacramento, CA), and July 31, 2000 
(Washington, DC), joint public meetings were held by FDA and FSIS to 
solicit and discuss information related to the implementation of the 
objectives in the Egg Safety Action Plan.
On September 22, 2004, FDA published a proposed rule that would require 
egg safety measures to prevent the contamination of shell eggs with SE 
during egg production. This proposal would reduce SE prevalence in the 
egg production environment and consequently in the eggs themselves. 
Most SE contamination of eggs is a result of SE infection in the laying 
hen's reproductive tract, called transovarian contamination. The 
proposed measures are designed to reduce the likelihood of this 
transovarian contamination and include: (1) Provisions for procurement 
of chicks and pullets; (2) a biosecurity program; (3) a rodent and pest 
control program; (4) cleaning and disinfection of poultry houses that 
have had an environmental or egg test positive for SE; (5) egg testing 
when an environmental test is positive; and (6) refrigerated storage of 
eggs held at the farm.
Additionally, to verify that the measures have been effective, the rule 
proposes that producers test the poultry house environment for SE. If 
the environmental test is positive, eggs from that environment must be 
tested for SE, and if the egg test is positive, the eggs must be 
diverted to egg products processing or a treatment process that 
achieves at least a 5-log destruction of SE.
The proposed rule is one step in a broader farm-to-table egg safety 
effort that includes FDA's requirements for safe handling statements on 
egg cartons and refrigerated storage of shell eggs at retail and egg 
safety education for consumers and retail establishments. The rule had 
a 90-day comment period, which ended December 21, 2004. To discuss the 
proposed rule and solicit comments from interested stakeholders, FDA 
held three public meetings: October 28, 2004, in College Park, MD; 
November 9, 2004, in Chicago, IL; and November 16, 2004, in Los 
Angeles, CA.
The comment period was reopened until July 25, 2005 to solicit further 
comment and information on industry practices and programs that prevent 
SE monitored chicks from becoming infected by SE during the period of 
pullet rearing until placement into laying hen houses.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/22/04                    69 FR 56824
Final Action                    06/00/07

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: State

Federalism:  This action may have federalism implications as defined in 
EO 13132.

Agency Contact: John Sheehan, Director, Department of Health and Human 
Services, Food and Drug Administration, Division o Dairy and Egg Safety 
(HFS-032), 5100 Paint Branch Parkway, College Park, MD 20740
Phone: 301 436-1488
Fax: 301 436-2632
Email: [email protected]

RIN: 0910-AC14
_______________________________________________________________________




1053. INSTITUTIONAL REVIEW BOARDS: REGISTRATION REQUIREMENTS

Priority: Info./Admin./Other

Legal Authority: 21 USC 321; 21 USC 346 to 21 USC 346a; 21 USC 348; 21 
USC 351 to 353; 21 USC 355; 21 USC 360; 21 USC 360c to 360f; 21 USC 
360h to 360j; 21 USC 371; 21 USC 379e; 21 USC 381; 42 USC 216; 42 USC 
241; 42 USC 262; 42 USC 263b to 263n

CFR Citation: 21 CFR 56.106

Legal Deadline: None

Abstract: The final rule would require institutional review boards 
(IRB) to register with the Department of Health and Human Services. The 
registration information would include the name of the IRB, the name of 
the institution operating the IRB, and names, addresses, phone numbers, 
facsimile (fax) numbers, and electronic mail (e-mail) addresses of the 
senior officer of the institution and IRB chair or contact, the number 
of active protocols involving FDA-regulated products reviewed in the 
previous calendar year, and a description of the types of FDA-regulated 
products reviewed. The final rule would make it easier for FDA to 
inspect IRBs and to convey information to IRBs.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            07/06/04                    69 FR 40556
Final Action                    04/00/07

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Philip L. Chao, Senior Policy Analyst, Department of 
Health and Human Services, Food and Drug Administration, Office of 
Policy and Planning (HF-23), 5600 Fishers Lane, Room 14C-17, Rockville, 
MD 20857
Phone: 301 827-0587
Fax: 301 827-4774
Email: [email protected]

RIN: 0910-AC17
_______________________________________________________________________




1054. EXCEPTION FROM GENERAL REQUIREMENTS FOR INFORMED CONSENT; REQUEST 
FOR COMMENTS AND INFORMATION

Priority: Other Significant

Legal Authority: 21 USC 321; 21 USC 351; 21 USC 352; 21 USC 355; 21 USC 
360; 21 USC 360bbb; 21 USC 360c; 21 USC 360d; 21 USC 360e; 21 USC 360f; 
21 USC 360h; 21 USC 360i; 21 USC 360j; 21 USC 371; 21 USC 381

CFR Citation: 21 CFR 50.23

Legal Deadline: None

Abstract: This final rule will add an exception from the general 
requirement for informed consent in certain circumstances involving the 
use of investigational in vitro diagnostic devices to identify 
chemical, biological, radiological, or nuclear agents in a potential 
terrorist event or other public health emergency.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              06/07/06                    71 FR 32827
Final Action                    04/00/07

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: State

Federalism:  This action may have federalism implications as defined in 
EO 13132.

Agency Contact: Catherine Lorraine, Director, Policy Development and

[[Page 73227]]

Coordination Group, Office of Policy and Planning, Department of Health 
and Human Services, Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857
Phone: 301 827-3360
Fax: 301 594-6777

RIN: 0910-AC25
_______________________________________________________________________




1055. MEDICAL DEVICES; PATIENT EXAMINATION AND SURGEONS' GLOVES; TEST 
PROCEDURES AND ACCEPTANCE CRITERIA

Priority: Routine and Frequent

Legal Authority: 21 USC 321; 21 USC 331; 21 USC 351; 21 USC 352; 21 USC 
371; 21 USC 374

CFR Citation: 21 CFR 800.20

Legal Deadline: None

Abstract: The final rule amends the sampling plans, test method, and 
acceptable quality levels in 21 CFR 800.20. As prescribed by this 
regulation, FDA samples patient examination and surgeons' gloves and 
examines them for visual defects and water leaks. Glove lots are 
considered adulterated if they do not meet specified quality levels. 
This rule will clarify sampling plans and the scoring of defects, lower 
acceptance rates for leaking gloves, raise rejection rates for leaking 
gloves, and add tightened inspection schemes for reexamined glove lots. 
The rule is intended to facilitate industry compliance and enhance the 
safety and effectiveness of gloves.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            03/31/03                    68 FR 15404
NPRM Comment Period End         06/30/03
Final Action                    12/00/06

Regulatory Flexibility Analysis Required: No

Government Levels Affected: Undetermined

Federalism:  Undetermined

Agency Contact: Myrna Hanna, Regulations Staff, Department of Health 
and Human Services, Food and Drug Administration, Center for Devices 
and Radiological Health, HFZ-215, 1350 Piccard Drive, PI50 RM150F, 
Rockville, MD 20850
Phone: 240 276-2347
Fax: 240 276-2352
Email: [email protected]

RIN: 0910-AC32
_______________________________________________________________________




1056. TOLL-FREE NUMBER FOR REPORTING ADVERSE EVENTS ON LABELING FOR 
HUMAN DRUGS

Priority: Other Significant

Legal Authority: 21 USC 355b

CFR Citation: 21 CFR 201; 21 CFR 208; 21 CFR 209

Legal Deadline: Final, Statutory, January 4, 2003.

Abstract: To require the labeling of human drugs approved under section 
505 of the Federal Food, Drug, and Cosmetic Act to include a toll-free 
number for reports of adverse events, and a statement that the number 
is to be used for reporting purposes only and not to receive medical 
advice.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            04/22/04                    69 FR 21778
NPRM Comment Period End         07/21/04
Final Action                    09/00/07

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Carol Drew, Regulatory Counsel, Department of Health 
and Human Services, Food and Drug Administration, Center for Drug 
Evaluation and Research, 5515 Security Lane, Suite 1101 (HFD-7), 
Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562

RIN: 0910-AC35
_______________________________________________________________________




1057. PRIOR NOTICE OF IMPORTED FOOD UNDER THE PUBLIC HEALTH SECURITY AND 
BIOTERRORISM PREPAREDNESS AND RESPONSE ACT OF 2002

 Regulatory Plan: This entry is Seq. No. 43 in part II of this issue of 
the Federal Register.

RIN: 0910-AC41
_______________________________________________________________________




1058. MEDICAL GAS CONTAINERS AND CLOSURES; CURRENT GOOD MANUFACTURING 
PRACTICE REQUIREMENTS

Priority: Other Significant

Legal Authority: 21 USC 321; 21 USC 351 to 21 USC 353

CFR Citation: 21 CFR 201.161(a); 21 CFR 211.94; 21 CFR 211.125

Legal Deadline: None

Abstract: The Food and Drug Administration is proposing to amend its 
current good manufacturing practice regulations and other regulations 
to clarify and strengthen requirements for the label, color, 
dedication, and design of medical gas containers and closures. Despite 
existing regulatory requirements and industry standards for medical 
gases, there have been repeated incidents in which cryogenic containers 
of harmful industrial gases have been connected to medical oxygen 
supply systems in hospitals and nursing homes, and subsequently 
administered to patients. These incidents have resulted in death and 
serious injury. There have also been several incidents involving high-
pressure medical gas cylinders that have resulted in death and injuries 
to patients. These proposed amendments, together with existing 
regulations, are intended to ensure that the types of incidents that 
have occurred in the past, as well as other types of foreseeable and 
potentially deadly medical gas mixups, do not occur in the future.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            04/10/06                    71 FR 18039
NPRM Comment Period End         07/10/06
Final Action                    04/00/07

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: None

Agency Contact: Quynh H. Nguyen, Regulatory Counsel, Department of 
Health and Human Services, Food and Drug Administration, Office of 
Regulatory Policy, Center for Drug Evaluation and Research, 5515 
Security Lane, Suite 1101 (HFD-7), Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562
Email: [email protected]

RIN: 0910-AC53

[[Page 73228]]

_______________________________________________________________________




1059. POSITRON EMISSION TOMOGRAPHY DRUGS; CURRENT GOOD MANUFACTURING 
PRACTICES

Priority: Other Significant

Legal Authority: PL 105-115, sec 121

CFR Citation: 21 CFR 212

Legal Deadline: Final, Statutory, November 21, 1999.

Abstract: Section 121 of the Food and Drug Administration Modernization 
Act of 1997 (Pub. L. 105-115) directs FDA to establish requirements for 
current good manufacturing practices (CGMPs) for positron emission 
tomography (PET) drugs, a type of radiopharmaceutical. The proposed 
rule would adopt CGMPs that reflect the unique characteristics of PET 
drugs.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/20/05                    70 FR 55038
NPRM Comment Period End         12/19/05
Final Action                    05/00/07

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Governmental Jurisdictions

Government Levels Affected: Federal, State

URL For More Information:
www.fda.gov/cder/regulatory/pet

Agency Contact: Brian L. Pendleton, Regulatory Counsel, Department of 
Health and Human Services, Food and Drug Administration, Center for 
Drug Evaluation and Research, 5515 Security Lane, Suite 1101 (HFD-7), 
Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562
Email: [email protected]

Related RIN: Previously reported as 0910-AB63
RIN: 0910-AC55
_______________________________________________________________________




1060. HUMAN SUBJECT PROTECTION; FOREIGN CLINICAL STUDIES NOT CONDUCTED 
UNDER AN INVESTIGATIONAL NEW DRUG APPLICATION

Priority: Substantive, Nonsignificant. Major status under 5 USC 801 is 
undetermined.

Legal Authority: 21 USC 355(d)(5); 21 USC 355(i); 21 USC 371(a); 42 USC 
262(a)(2)(A); 42 USC 262(a)(2)(B)(i)(l)

CFR Citation: 21 CFR 312.120

Legal Deadline: None

Abstract: This final rule follows a proposed rule, which proposed to 
update the standards for the acceptance of foreign clinical studies not 
conducted under an investigational new drug application (IND) as 
support for an IND or marketing application for a drug or biological 
product. We proposed to replace the requirement in 21 CFR 312.120 that 
non-IND foreign clinical studies be conducted in accordance with 
ethical principles stated in the Declaration of Helsinki or with the 
laws and regulations of the country that is the research site, 
whichever provide greater protection to subjects. We would replace that 
with a requirement that such studies be conducted in accordance with 
good clinical practice (GCP), including review and approval by an 
independent ethics committee. The proposed GCP standard is consistent 
with the standard of the International Conference on Harmonisation of 
Technical Requirements for Registration of Pharmaceuticals for Human 
Use for GCP and is sufficiently flexible to accommodate differences in 
how countries regulate the conduct of clinical research and obtain the 
informed consent of patients.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/10/04                    69 FR 32467
Final Action                    02/00/07

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Brian L. Pendleton, Regulatory Counsel, Department of 
Health and Human Services, Food and Drug Administration, Center for 
Drug Evaluation and Research, 5515 Security Lane, Suite 1101 (HFD-7), 
Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562
Email: [email protected]

RIN: 0910-AF15
_______________________________________________________________________




1061. DISTRIBUTION OF BLOOD DERIVATIVES BY REGISTERED BLOOD 
ESTABLISHMENTS THAT QUALIFY AS HEALTH CARE ENTITIES; PDMA OF 1987; PDA 
OF 1992; POLICIES, REQUIREMENTS, AND ADMINISTRATIVE PROCEDURES

Priority: Substantive, Nonsignificant

Legal Authority: 21 USC 351 to 353; 21 USC 371; 21 USC 374

CFR Citation: 21 CFR 203.3(q); 21 CFR 203.22(h); 21 CFR 205.3(h)

Legal Deadline: None

Abstract: FDA is amending certain limited provisions of the 
implementing regulations of the Prescription Drug Marketing Act (PDMA) 
of 1987, as modified by the Prescription Drug Amendments (PDA) of 1992 
and the FDA Modernization Act of 1997. Certain provisions of that final 
rule that published on December 3, 1999 (64 FR 67720), would not allow 
registered blood establishments or hemophilia treatment centers that 
provide health care services to concurrently distribute drugs, 
including blood derivatives. The effective date of those provisions of 
that rule is December 1, 2006, as published on February 23, 2004 (69 FR 
8105). FDA intends to delay the effective date of those provisions 
while FDA is considering comments on the proposed rule. FDA is amending 
the final rule to allow registered blood establishments and certain 
hemophilia treatment centers that concurrently provide health care 
services related to their activities as blood establishments or 
hemophilia treatment centers to also distribute certain products, 
including blood derivatives.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            02/01/06                     71 FR 5200
NPRM Comment Period End         05/02/06
Final Action                    10/00/07

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Additional Information: Delayed effective date of portion of rule to 
12/01/06, effective date of non-stayed portion of final rule, 64 FR 
67720, December 3, 1999

Agency Contact: Kathleen E. Swisher, Supervisory Regulatory Counsel, 
Department of Health and Human Services, Food and Drug

[[Page 73229]]

Administration, Center for Biologics Evaluation and Research, 1401 
Rockville Pike, Suite 200N, (HFM-17), Rockville, MD 20852
Phone: 301 827-6210
Fax: 301 827-9434

RIN: 0910-AF16
_______________________________________________________________________




1062. OBSTETRICAL AND GYNECOLOGICAL DEVICES; DESIGNATION OF SPECIAL 
CONTROL FOR CONDOMS AND CONDOMS WITH SPERMICIDAL LUBRICANT

Priority: Other Significant

Legal Authority: 21 USC 360c

CFR Citation: 21 CFR 884.5300; 21 CFR 884.5310

Legal Deadline: None

Abstract: The classification regulations for male condoms would be 
amended to specify a labeling guidance document as a special control 
for condoms made from natural rubber latex. The new special control 
guidance document would identify issues presented by these devices, and 
would provide detailed recommendations for labeling to address these 
issues. FDA believes that compliance with the recommendations in the 
guidance, or with some equivalent means of addressing the identified 
issues, together with the general controls, will provide a reasonable 
assurance of the safety and effectiveness of these devices. These 
labeling recommendations are also consistent with the labeling 
requirements of 21 CFR 801. The rule will demonstrate how the Agency is 
moving forward to meet the congressional directive of Public Law 106-
554 that FDA review condom labeling to assure that the information 
regarding the overall effectiveness or lack of effectiveness of condoms 
in preventing sexually transmitted diseases is medically accurate.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            11/14/05                    70 FR 69102
Final Action                    07/00/07

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Myrna Hanna, Regulations Staff, Department of Health 
and Human Services, Food and Drug Administration, Center for Devices 
and Radiological Health, HFZ-215, 1350 Piccard Drive, PI50 RM150F, 
Rockville, MD 20850
Phone: 240 276-2347
Fax: 240 276-2352
Email: [email protected]

RIN: 0910-AF21
_______________________________________________________________________




1063. BLOOD INITIATIVE--REVISIONS TO LABELING REQUIREMENTS FOR BLOOD AND 
BLOOD COMPONENTS, INCLUDING SOURCE PLASMA; AND TECHNICAL AMENDMENT

Priority: Other Significant

Legal Authority: 21 USC 310; 21 USC 321; 21 USC 331; 21 USC 351 to 353; 
21 USC 355; 21 USC 360; 21 USC 360d; 21 USC 360h to 360j; 21 USC 371; 
21 USC 374; 21 USC 381; 42 USC 216; 42 USC 262; 42 USC 263; 42 USC 
263a; 42 USC 264; 42 USC 300aa to 25

CFR Citation: 21 CFR 606; 21 CFR 610; 21 CFR 640

Legal Deadline: None

Abstract: The Food and Drug Administration (FDA) is amending the 
regulations regarding container labels and instruction circulars for 
certain human blood and blood components, including Source Plasma to be 
more consistent with current practices and to remove unnecessary or 
outdated requirements. This action is based on FDA's comprehensive 
review of the biologics regulations. It is also based on reports by the 
U.S. House of Representatives Committee on Government Reform and 
Oversight Subcommittee on House Resources and Intergovernmental 
Relations, the General Accounting Office, and the Institute of 
Medicine, as well as on public comments. This action is intended to 
help ensure the continued safety of the blood supply and to help ensure 
consistency in container labeling.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            07/30/03                    68 FR 44678
NPRM Comment Period End         10/28/03
Final Action                    10/00/07

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Brenda R. Friend, Regulatory Counsel, Department of 
Health and Human Services, Food and Drug Administration, Center for 
Biologics Evaluation and Research, HFM-17, 1410 Rockville Pike, Suite 
200N, Rockville, MD 20852-1448
Phone: 301 827-6210
Fax: 301 827-9434

Related RIN: Split from 0910-AB26
RIN: 0910-AF26
_______________________________________________________________________




1064. INFANT FORMULA: CURRENT GOOD MANUFACTURING PRACTICES; QUALITY 
CONTROL PROCEDURES; NOTIFICATION REQUIREMENTS; RECORDS AND REPORTS

Priority: Other Significant

Legal Authority: 21 USC 321; 21 USC 350a; 21 USC 371; . . .

CFR Citation: 21 CFR 106; 21 CFR 107

Legal Deadline: None

Abstract: The Agency published a proposed rule on July 9, 1996, that 
would establish current good manufacturing practice regulations, 
quality control procedures, quality factors, notification requirements, 
and records and reports for the production of infant formula. This 
proposal was issued in response to the 1986 Amendments to the Infant 
Formula Act of 1980. On April 28, 2003, FDA reopened the comment period 
to update comments on the proposal. The comment period was extended on 
June 27, 2003, to end on August 26, 2003.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            07/09/96                    61 FR 36154
NPRM Comment Period End         12/06/96
NPRM Comment Period Reopened    04/28/03                    68 FR 22341
NPRM Comment Period Extended    06/27/03                    68 FR 38247
NPRM Comment Period End         08/26/03
NPRM Comment Period Reopened    08/01/06                    71 FR 43392
NPRM Comment Period End         09/15/06
Final Action                    09/00/07

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Benson Silverman, Department of Health and Human

[[Page 73230]]

Services, Food and Drug Administration, Center for Food Safety and 
Applied Nutrition, 5100 Paint Branch Parkway, HFS-024, College Park, MD 
20740
Phone: 301 436-1459
Email: [email protected]

Related RIN: Split from 0910-AA04
RIN: 0910-AF27
_______________________________________________________________________




1065. INFANT FORMULA QUALITY FACTORS

Priority: Other Significant

Legal Authority: 21 USC 321; 21 USC 350a; 21 USC 371; . . .

CFR Citation: 21 CFR 106; 21 CFR 107

Legal Deadline: None

Abstract: The Agency published a proposed rule on July 9, 1996, that 
would establish current good manufacturing practice regulations, 
quality control procedures, quality factors, notification requirements, 
and records and reports for the production of infant formula. This 
proposal was issued in response to the 1986 Amendments to the Infant 
Formula Act of 1980. On April 28, 2003, FDA reopened the comment period 
to update comments on the proposal. The comment period was extended on 
June 27, 2003, to end on August 26, 2003. The comment period was 
reopened on August 1, 2006 to end on September 15, 2006.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            07/09/96                    61 FR 36154
NPRM Comment Period End         12/06/96
NPRM Comment Period Reopened    04/28/03                    68 FR 22341
NPRM Comment Period Extended    06/27/03                    68 FR 38247
NPRM Comment Period End         08/26/03
Final Action                    09/00/07

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Benson Silverman, Department of Health and Human 
Services, Food and Drug Administration, Center for Food Safety and 
Applied Nutrition, 5100 Paint Branch Parkway, HFS-024, College Park, MD 
20740
Phone: 301 436-1459
Email: [email protected]

Related RIN: Split from 0910-AA04
RIN: 0910-AF28
_______________________________________________________________________




1066. OVER-THE-COUNTER (OTC) DRUG REVIEW--COUGH/COLD (ANTIHISTAMINE) 
PRODUCTS

Priority: Routine and Frequent

Legal Authority: 21 USC 321p; 21 USC 351 to 353; 21 USC 355; 21 USC 
360a; 21USC 371a; 21 USC 331; 21 USC 360; 21 USC 371

CFR Citation: 21 CFR 201; 21 CFR 310; 21 CFR 330 to 358

Legal Deadline: None

Abstract: The OTC drug review establishes conditions under which OTC 
drugs are considered generally recognized as safe and effective and not 
misbranded. After a final monograph (i.e., final rule) is issued, only 
OTC drugs meeting the conditions of the monograph, or having an 
approved new drug application, may be legally marketed. This action 
addresses labeling claims for the common cold.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Action (Amendment) (Common 
Cold)                           06/00/07

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: Local, State

Federalism:  This action may have federalism implications as defined in 
EO 13132.

Agency Contact: Gerald M. Rachanow, Regulatory Counsel, Division of 
Over-the-Counter Drug Products, Department of Health and Human 
Services, Food and Drug Administration, Center for Drug Evaluation and 
Research, 5600 Fishers Lane, HFD-560, Rockville, MD 20857
Phone: 301 827-2241
Fax: 301 827-2315
Email: [email protected]

Related RIN: Split from 0910-AA01
RIN: 0910-AF31
_______________________________________________________________________




1067. OVER-THE-COUNTER (OTC) DRUG REVIEW--COUGH/COLD (BRONCHODILATOR) 
PRODUCTS

Priority: Routine and Frequent

Legal Authority: 21 USC 321p; 21 USC 351 to 353; 21 USC 355; 21 USC 
360a; 21USC 371a; 21 USC 331; 21 USC 360; 21 USC 371

CFR Citation: 21 CFR 201; 21 CFR 310; 21 CFR 330 to 358

Legal Deadline: None

Abstract: The OTC drug review establishes conditions under which OTC 
drugs are considered generally recognized as safe and effective and not 
misbranded. After a final monograph (i.e., final rule) is issued, only 
OTC drugs meeting the conditions of the monograph, or having an 
approved new drug application, may be legally marketed. This action 
addresses labeling for these products.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM (Amendment)                07/13/05                    70 FR 40237
Final Action                    06/00/07

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: Local, State

Federalism:  This action may have federalism implications as defined in 
EO 13132.

Agency Contact: Gerald M. Rachanow, Regulatory Counsel, Division of 
Over-the-Counter Drug Products, Department of Health and Human 
Services, Food and Drug Administration, Center for Drug Evaluation and 
Research, 5600 Fishers Lane, HFD-560, Rockville, MD 20857
Phone: 301 827-2241
Fax: 301 827-2315
Email: [email protected]

Related RIN: Split from 0910-AA01
RIN: 0910-AF32
_______________________________________________________________________




1068. OVER-THE-COUNTER (OTC) DRUG REVIEW--COUGH/COLD (COMBINATION) 
PRODUCTS

Priority: Routine and Frequent

Legal Authority: 21 USC 321p; 21 USC 351 to 353; 21 USC 355; 21 USC 
360a; 21USC 371a; 21 USC 331; 21 USC 360; 21 USC 371

CFR Citation: 21 CFR 201; 21 CFR 310; 21 CFR 330 to 358

[[Page 73231]]

Legal Deadline: None

Abstract: The OTC drug review establishes conditions under which OTC 
drugs are considered generally recognized as safe and effective and not 
misbranded. After a final monograph (i.e., final rule) is issued, only 
OTC drugs meeting the conditions of the monograph, or having an 
approved new drug application, may be legally marketed. This action 
addresses combination products containing an oral bronchodilator.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM (Amendment)                07/13/05                    70 FR 40232
Final Action                    06/00/07

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: Local, State

Federalism:  This action may have federalism implications as defined in 
EO 13132.

Agency Contact: Gerald M. Rachanow, Regulatory Counsel, Division of 
Over-the-Counter Drug Products, Department of Health and Human 
Services, Food and Drug Administration, Center for Drug Evaluation and 
Research, 5600 Fishers Lane, HFD-560, Rockville, MD 20857
Phone: 301 827-2241
Fax: 301 827-2315
Email: [email protected]

Related RIN: Split from 0910-AA01
RIN: 0910-AF33
_______________________________________________________________________




1069. OVER-THE-COUNTER (OTC) DRUG REVIEW--COUGH/COLD (NASAL 
DECONGESTANT) PRODUCTS

Priority: Routine and Frequent

Legal Authority: 21 USC 321p; 21 USC 351 to 353; 21 USC 355; 21 USC 
360a; 21 USC 371a; 21 USC 331; 21 USC 360; 21 USC 371

CFR Citation: 21 CFR 201; 21 CFR 310; 21 CFR 330 to 358

Legal Deadline: None

Abstract: The OTC drug review establishes conditions under which OTC 
drugs are considered generally recognized as safe and effective and not 
misbranded. After a final monograph (i.e., final rule) is issued, only 
OTC drugs meeting the conditions of the monograph, or having an 
approved new drug application, may be legally marketed. One action 
addresses the ingredient phenylephrine bitartrate, and the other action 
addresses the ingredient phenyl propanolamine.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM (Amendment) (Sinusitis 
Claim)                          08/02/04                    69 FR 46119
NPRM (Phenylephrine Bitartrate) 11/02/04                    69 FR 63482
NPRM (Phenylpro panolamine)     12/22/05                    70 FR 75988
Final Action (Amendment) 
(Sinusitis Claim)               10/31/05                    70 FR 58974
Final Action (Phenylephrine 
Bitartrate)                     08/01/06                    71 FR 83358
Final Action (Phenyl 
propanolamine)                  05/00/07

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: Local, State

Federalism:  This action may have federalism implications as defined in 
EO 13132.

Agency Contact: Gerald M. Rachanow, Regulatory Counsel, Division of 
Over-the-Counter Drug Products, Department of Health and Human 
Services, Food and Drug Administration, Center for Drug Evaluation and 
Research, 5600 Fishers Lane, HFD-560, Rockville, MD 20857
Phone: 301 827-2241
Fax: 301 827-2315
Email: [email protected]

Related RIN: Split from 0910-AA01
RIN: 0910-AF34
_______________________________________________________________________




1070. OVER-THE-COUNTER (OTC) DRUG REVIEW--EXTERNAL ANALGESIC PRODUCTS

Priority: Routine and Frequent

Legal Authority: 21 USC 321p; 21 USC 351 to 353; 21 USC 355; 21 USC 
360a; 21USC 371a; 21 USC 331; 21 USC 360; 21 USC 371

CFR Citation: 21 CFR 201; 21 CFR 310; 21 CFR 330 to 358

Legal Deadline: None

Abstract: The OTC drug review establishes conditions under which OTC 
drugs are considered generally recognized as safe and effective and not 
misbranded. After a final monograph (i.e., final rule) is issued, only 
OTC drugs meeting the conditions of the monograph, or having an 
approved new drug application, may be legally marketed. This action 
will address external analgesic drug products.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Action                    09/00/07

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: Local, State

Federalism:  This action may have federalism implications as defined in 
EO 13132.

Agency Contact: Gerald M. Rachanow, Regulatory Counsel, Division of 
Over-the-Counter Drug Products, Department of Health and Human 
Services, Food and Drug Administration, Center for Drug Evaluation and 
Research, 5600 Fishers Lane, HFD-560, Rockville, MD 20857
Phone: 301 827-2241
Fax: 301 827-2315
Email: [email protected]

Related RIN: Split from 0910-AA01
RIN: 0910-AF35
_______________________________________________________________________




1071. OVER-THE-COUNTER (OTC) DRUG REVIEW--LAXATIVE DRUG PRODUCTS

Priority: Routine and Frequent

Legal Authority: 21 USC 321p; 21 USC 351 to 353; 21 USC 355; 21 USC 
360a; 21USC 371a; 21 USC 331; 21 USC 360; 21 USC 371

CFR Citation: 21 CFR 201; 21 CFR 310; 21 CFR 330 to 358

Legal Deadline: None

Abstract: The OTC drug review establishes conditions under which OTC 
drugs are considered generally recognized as safe and effective and not 
misbranded. After a final monograph (i.e., final rule) is issued, only 
OTC drugs meeting the conditions of the monograph, or having an 
approved new drug application, may be legally marketed. One action will 
address laxative drug products. The other action will address psyllium 
laxative drug products in a granular dosage form.

[[Page 73232]]

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Action (Granular Psyllium)05/00/07
Final Action (Laxative Drug 
Products)                       06/00/07

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: Local, State

Federalism:  This action may have federalism implications as defined in 
EO 13132.

Agency Contact: Gerald M. Rachanow, Regulatory Counsel, Division of 
Over-the-Counter Drug Products, Department of Health and Human 
Services, Food and Drug Administration, Center for Drug Evaluation and 
Research, 5600 Fishers Lane, HFD-560, Rockville, MD 20857
Phone: 301 827-2241
Fax: 301 827-2315
Email: [email protected]

Related RIN: Split from 0910-AA01
RIN: 0910-AF38
_______________________________________________________________________




1072. OVER-THE-COUNTER (OTC) DRUG REVIEW--SKIN PROTECTANT PRODUCTS

Priority: Routine and Frequent

Legal Authority: 21 USC 321p; 21 USC 351 to 353; 21 USC 355; 21 USC 
360a; 21 USC 371a; 21 USC 331; 21 USC 360; 21 USC 371

CFR Citation: 21 CFR 201; 21 CFR 310; 21 CFR 330 to 358

Legal Deadline: None

Abstract: The OTC drug review establishes conditions under which OTC 
drugs are considered generally recognized as safe and effective and not 
misbranded. After a final monograph (i.e., final rule) is issued, only 
OTC drugs meeting the conditions of the monograph, or having an 
approved new drug application, may be legally marketed. One action 
addresses labeling for products formulated and marketed as lip 
protectants. The second action addresses skin protectant products to 
protect and treat fever blisters and cold sores.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Action (Technical 
Amendments)                     03/00/07
Final Action (Fever Blisters/
Cold Sores)                     06/00/07
Final Action (Diaper Rash)      06/00/07
NPRM (Amendment) (Diaper Rash 
Drug Product)                   06/00/07

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: Local, State

Federalism:  This action may have federalism implications as defined in 
EO 13132.

Agency Contact: Gerald M. Rachanow, Regulatory Counsel, Division of 
Over-the-Counter Drug Products, Department of Health and Human 
Services, Food and Drug Administration, Center for Drug Evaluation and 
Research, 5600 Fishers Lane, HFD-560, Rockville, MD 20857
Phone: 301 827-2241
Fax: 301 827-2315
Email: [email protected]

Related RIN: Split from 0910-AA01
RIN: 0910-AF42
_______________________________________________________________________




1073. OVER-THE-COUNTER (OTC) DRUG REVIEW--VAGINAL CONTRACEPTIVE PRODUCTS

Priority: Routine and Frequent

Legal Authority: 21 USC 321p; 21 USC 351 to 353; 21 USC 355; 21 USC 
360a; 21 USC 371a; 21 USC 331; 21 USC 358; 21 USC 360; 21 USC 360gg to 
360ss; 21 USC 371; 21 USC 374; 21 USC 379e; 42 USC 216; 42 USC 241; 42 
USC 262; 42 USC 264

CFR Citation: 21 CFR 201; 21 CFR 310; 21 CFR 330 to 358

Legal Deadline: None

Abstract: The OTC drug review establishes conditions under which OTC 
drugs are considered generally recognized as safe and effective and not 
misbranded. After a final monograph (i.e., final rule) is issued, only 
OTC drugs meeting the conditions of the monograph, or having an 
approved new drug application, may be legally marketed. One action will 
address labeling warning statements for products containing Nonoxynol 
9. The other action addresses vaginal contraceptive drug products.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Action (Warnings)         12/00/06
NPRM (Vaginal Contraceptive Drug 
Products)                       06/00/07

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: Local, State

Federalism:  This action may have federalism implications as defined in 
EO 13132.

Agency Contact: Gerald M. Rachanow, Regulatory Counsel, Division of 
Over-the-Counter Drug Products, Department of Health and Human 
Services, Food and Drug Administration, Center for Drug Evaluation and 
Research, 5600 Fishers Lane, HFD-560, Rockville, MD 20857
Phone: 301 827-2241
Fax: 301 827-2315
Email: [email protected]

Related RIN: Split from 0910-AA01
RIN: 0910-AF44
_______________________________________________________________________




1074. OVER-THE-COUNTER (OTC) DRUG REVIEW--WEIGHT CONTROL PRODUCTS

Priority: Routine and Frequent

Legal Authority: 21 USC 321p; 21 USC 351 to 353; 21 USC 355; 21 USC 
360a; 21 USC 371a; 21 USC 331; 21 USC 360; 21 USC 371

CFR Citation: 21 CFR 201; 21 CFR 310; 21 CFR 330 to 358

Legal Deadline: None

Abstract: The OTC drug review establishes conditions under which OTC 
drugs are considered generally recognized as safe and effective and not 
misbranded. After a final monograph (i.e., final rule) is issued, only 
OTC drugs meeting the conditions of the monograph, or having an 
approved new drug application, may be legally marketed. One action 
addresses the ingredient phenyl propanolamine, and the other action 
addresses the ingredient benzocaine.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM (Phenyl propanolamine)     12/22/05                    70 FR 75988
NPRM (Benzocaine)               06/00/07

[[Page 73233]]

Final Action (Phenyl 
propanolamine)                  05/00/07

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: Local, State

Federalism:  This action may have federalism implications as defined in 
EO 13132.

Agency Contact: Gerald M. Rachanow, Regulatory Counsel, Division of 
Over-the-Counter Drug Products, Department of Health and Human 
Services, Food and Drug Administration, Center for Drug Evaluation and 
Research, 5600 Fishers Lane, HFD-560, Rockville, MD 20857
Phone: 301 827-2241
Fax: 301 827-2315
Email: [email protected]

Related RIN: Split from 0910-AA01
RIN: 0910-AF45
_______________________________________________________________________




1075. OVER-THE-COUNTER (OTC) DRUG REVIEW--DANDRUFF, SEBORRHEIC 
DERMATITIS, AND PSORIASIS PRODUCTS

Priority: Routine and Frequent

Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 
355; 21 USC 360; 21 USC 360a; 21 USC 371; 21 USC 371a

CFR Citation: 21 CFR 201; 21 CFR 310; 21 CFR 330 to 358

Legal Deadline: None

Abstract: The OTC drug review establishes conditions under which OTC 
drugs are considered generally recognized as safe and effective and not 
misbranded. After a final monograph (i.e., final rule) is issued, only 
OTC drugs meeting the conditions of the monograph, or having an 
approved new drug application, may be legally marketed. This action 
addresses combinations containing coal tar solution and menthol in a 
shampoo product.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM (Amendment)                12/09/05                    70 FR 73178
Final Action                    06/00/07

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: Local, State

Federalism:  This action may have federalism implications as defined in 
EO 13132.

Agency Contact: Gerald M. Rachanow, Regulatory Counsel, Division of 
Over-the-Counter Drug Products, Department of Health and Human 
Services, Food and Drug Administration, Center for Drug Evaluation and 
Research, 5600 Fishers Lane, HFD-560, Rockville, MD 20857
Phone: 301 827-2241
Fax: 301 827-2315
Email: [email protected]

RIN: 0910-AF49
_______________________________________________________________________




1076. OVER-THE-COUNTER (OTC) DRUG REVIEW--OVERINDULGENCE IN FOOD AND 
DRINK PRODUCTS

Priority: Routine and Frequent

Legal Authority: 21 USC 321p; 21 USC 351 to 353; 21 USC 355; 21 USC 
360; 21 USC 360a; 21 USC 371; 21 USC 371a; 21 USC 331

CFR Citation: 21 CFR 201; 21 CFR 310; 21 CFR 330 to 358

Legal Deadline: None

Abstract: The OTC drug review establishes conditions under which OTC 
drugs are considered generally recognized as safe and effective and not 
misbranded. After a final monograph (i.e., final rule) is issued, only 
OTC drugs meeting the conditions of the monograph, or having an 
approved new drug application, may be legally marketed. This action 
addresses products containing bismuth subsalicylate for relief of 
symptoms of upset stomach due to overindulgence resulting from food and 
drink.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM (Amendment)                01/05/05                      70 FR 741
Final Action                    06/00/07

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: Local, State

Federalism:  This action may have federalism implications as defined in 
EO 13132.

Agency Contact: Gerald M. Rachanow, Regulatory Counsel, Division of 
Over-the-Counter Drug Products, Department of Health and Human 
Services, Food and Drug Administration, Center for Drug Evaluation and 
Research, 5600 Fishers Lane, HFD-560, Rockville, MD 20857
Phone: 301 827-2241
Fax: 301 827-2315
Email: [email protected]

RIN: 0910-AF51
_______________________________________________________________________




1077. OVER-THE-COUNTER (OTC) DRUG REVIEW--ANTACID PRODUCTS

Priority: Routine and Frequent

Legal Authority: 21 USC 321p; 21 USC 351 to 353; 21 USC 355; 21 USC 
360; 21 USC 360a; 21 USC 371; 21 USC 371a; 21 USC 331

CFR Citation: 21 CFR 201; 21 CFR 310; 21 CFR 330 to 358

Legal Deadline: None

Abstract: The OTC drug review establishes conditions under which OTC 
drugs are considered generally recognized as safe and effective and not 
misbranded. After a final monograph (i.e., final rule) is issued, only 
OTC drugs meeting the conditions of the monograph, or having an 
approved new drug application, may be legally marketed. One action 
addresses the labeling of products containing sodium bicarbonate as an 
active ingredient. The other action addresses the use of antacids to 
relieve upset stomach associated with overindulgence in food and drink.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Action (Overindulgence 
Labeling)                       06/00/07
Final Action (Sodium Bicarbonate 
Labeling)                       06/00/07

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: Local, State

Federalism:  This action may have federalism implications as defined in 
EO 13132.

Agency Contact: Gerald M. Rachanow, Regulatory Counsel, Division of 
Over-the-Counter Drug Products, Department of Health and Human 
Services, Food and Drug Administration, Center for Drug

[[Page 73234]]

Evaluation and Research, 5600 Fishers Lane, HFD-560, Rockville, MD 
20857
Phone: 301 827-2241
Fax: 301 827-2315
Email: [email protected]

RIN: 0910-AF52
_______________________________________________________________________




1078. SUPPLEMENTS AND OTHER CHANGES TO APPROVED NEW ANIMAL DRUG 
APPLICATIONS

Priority: Substantive, Nonsignificant

Legal Authority: 21 USC 351; 21 USC 352; 21 USC 356a; 21 USC 360b; 21 
USC 371

CFR Citation: 21 CFR 25; 21 CFR 500; 21 CFR 514; 21 CFR 558

Legal Deadline: None

Abstract: The Food and Drug Administration (FDA) is amending its 
regulations on supplements and other changes to approved new animal 
drug applications (NADAs) or abbreviated new animal drug applications 
(ANADAs) to implement the manufacturing changes provision of the Food 
and Drug Modernization Act of 1997. The final rule requires 
manufacturers to assess the effect of a manufacturing change on the 
identity, strength, quality, purity, and potency of a drug as those 
factors relate to the safety or effectiveness of the drug. The final 
rule sets forth requirements for changes requiring submission and 
approval of a supplement before the distribution of the drug made using 
the change, changes requiring the submission of a supplement at least 
30 days prior to the distribution of the drug, changes requiring the 
submission of a supplement at the time of distribution of the drug, and 
changes to be described in an annual report.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            10/01/99                    64 FR 53281
Final Action                    12/00/06
Final Action Effective          02/00/07

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Dennis Bensley Jr., Chemist, Department of Health and 
Human Services, Food and Drug Administration, 7500 Standish Place, MPN-
2, Room 320, HFV-140, Rockville, MD 20855
Phone: 301 827-6956
Email: [email protected]

RIN: 0910-AF59
_______________________________________________________________________




1079. DESIGNATION OF NEW ANIMAL DRUGS FOR MINOR USES OR MINOR SPECIES

Priority: Other Significant

Legal Authority: 21 USC 360ccc-2

CFR Citation: 21 CFR 516

Legal Deadline: NPRM, Statutory, August 2, 2005.
Final, Statutory, August 2, 2006.

Abstract: The proposed rule was published on September 27, 2005, in 
response to the Minor Use and Minor Species (MUMS) Animal Health Act of 
2004. The proposed rule would implement section 573 of the MUMS Act 
which sets forth the requirements for drug sponsors requesting MUMS 
designation for proposed new animal drugs. MUMS designation of a new 
animal drug allows drug sponsors to be granted seven years of exclusive 
marketing rights for these limited demand new animal drugs once the 
drugs are approved or conditionally approved. This regulation would 
define content and format requirements for designation, requests 
changing designation ownership, and annual reporting requirements. This 
rule would also describe the criteria CVM will use for granting or 
denying these requests. Specific sections of the rule are dedicated to 
documentation of MUMS status in a request, granting MUMS designation, 
and revocation of MUMS designation. FDA intends to finalize this 
proposal after reviewing any comments received. This is a voluntary 
program for animal drug sponsors. A large number of these drug 
companies are classified as small businesses.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/27/05                    70 FR 56394
NPRM Comment Period End         12/12/05
Final Rule                      01/00/07

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Andrew J. Beaulieu, Director, Office of Minor Use and 
Minor Species Animal Drug Development, Department of Health and Human 
Services, Food and Drug Administration, Center for Veterinary Medicine, 
7519 Standish Place, Room 180, HFV-50, MPN-4, Rockville, MD 20855
Phone: 240 276-9090
Fax: 240 276-9001
Email: [email protected]

RIN: 0910-AF60
_______________________________________________________________________




1080. BLOOD VESSELS RECOVERED WITH ORGANS AND INTENDED FOR USE IN ORGAN 
TRANSPLANTATION

Priority: Substantive, Nonsignificant

Legal Authority: 42 USC 216; 42 USC 243; 42 USC 263a; 42 USC 264; 42 
USC 271; 42 USC 273 to 274d; 42 USC 1302; 42 USC 1306

CFR Citation: 21 CFR 1271; 42 CFR 121

Legal Deadline: None

Abstract: FDA and Health Resources and Services Administration (HRSA) 
issued a direct final rule and companion proposed rule to amend the 
regulations to consider as part of an organ (and regulated by HRSA) 
those blood vessels recovered with vascularized human organs that are 
intended for use in organ transplantation; and to exclude such blood 
vessels from the definition of human cells, tissues, and cellular and 
tissue-based products (regulated by FDA). We took this action to 
provide that blood vessels recovered with organs and intended for use 
in organ transplantation will be governed by the regulations pertaining 
to organs. We believe this change will eliminate unnecessary burden 
resulting from an organ procurement organization's efforts to comply 
with both FDA and HRSA requirements with respect to blood vessels (FDA 
jurisdiction) and organs (HRSA jurisdiction). We received significant 
adverse comments in response to the direct final rule. Therefore, the 
direct final rule is being withdrawn. FDA and HRSA intend to finalize 
the proposed rule after considering comments.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM - Companion to Direct Final 
Rule                            05/12/06                    71 FR 27649
Direct Final Rule               05/12/06                    71 FR 27606
Comment Period End              07/26/06
Direct Final Rule-Withdrawal    09/14/06                    71 FR 54198
Final Action                    09/00/07

[[Page 73235]]

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Denise Sanchez, Regulatory Policy Analyst, Department 
of Health and Human Services, Food and Drug Administration, Center for 
Biologics Evaluation and Research, HFM-17, 1401 Rockville Pike, 
Rockville, MD 20852-1448
Phone: 301 827-6210
Fax: 301 827-9434

RIN: 0910-AF65
_______________________________________________________________________




1081. [bull] EXCEPTIONS OR ALTERNATIVES TO LABELING REQUIREMENTS FOR 
PRODUCTS HELD BY THE STRATEGIC NATIONAL STOCKPILE

Priority: Other Significant

Legal Authority: 15 USC 1451 to 1561; 21 USC 321; 21 USC 331; 21 USC 
351 to 353; 21 USC 355 and 356; 21 USC 358; 21 USC 360; 21 USC 371 to 
375; 21 USC 379; 21 USC 381 and 382; 21 USC 393; 42 USC 216; 42 USC 
241; 42 USC 262 to 264; 42 USC 271

CFR Citation: 21 CFR 201; 21 CFR 312; 21 CFR 314; 21 CFR 601; 21 CFR 
610; 21 CFR 801; 21 CFR 807; 21 CFR 809; 21 CFR 812; 21 CFR 814

Legal Deadline: None

Abstract: FDA is issuing regulations to permit FDA Center Directors to 
grant an exception or alternative to certain regulatory labeling 
provisions applicable to human drugs, biological products, or medical 
devices that are or will be included in the Strategic National 
Stockpile (SNS). Under this rule, the appropriate Center Director may 
grant an exception or alternative to such labeling requirements if he 
or she determines that compliance with such requirements could 
adversely affect the safety, effectiveness, or availability of 
specified lots, batches, or other units of human drugs, biological 
products, or medical devices that are or will be included in the SNS. A 
grant of an exception or alternative under these regulations will 
include any safeguards or conditions deemed appropriate by the Center 
Director to ensure that the labeling of such products includes 
information for the safe and effective use of the products given their 
anticipated circumstances of use. This rule will facilitate the safety, 
effectiveness, and availability of appropriate medical countermeasures 
in the event of a public health emergency.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              05/00/07

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Astrid L. Szeto, Director Regulatory Review Officer, 
Department of Health and Human Services, Food and Drug Administration, 
Center for Biologics Evaluation and Research (HFM-17), 1401 Rockville 
Pike, Suite 200N, Rockville, MD 20852-1448
Phone: 301 827-6210
Fax: 301 827-9434
Email: [email protected]

RIN: 0910-AF90
_______________________________________________________________________


Department of Health and Human Services (HHS)         Long-Term Actions


Food and Drug Administration (FDA)



_______________________________________________________________________




1082. CHRONIC WASTING DISEASE: CONTROL OF FOOD PRODUCTS AND COSMETICS 
DERIVED FROM EXPOSED ANIMAL POPULATIONS

Priority: Other Significant

Legal Authority: 42 USC 264; 21 USC 301 et seq

CFR Citation: Not Yet Determined

Legal Deadline: None

Abstract: The Food and Drug Administration (FDA) is proposing to 
prohibit the use of cervids (deer, elk) for food, including dietary 
supplements, and cosmetics if the cervids have been exposed to chronic 
wasting disease (CWD). FDA is proposing this regulation because of 
potential risks to health.
CWD is a type of transmissible spongiform encephalopathy (TSE), a group 
of fatal, neurodegenerative diseases that include bovine spongiform 
encephalopathy (BSE) in cattle, scrapie in sheep and goats, and 
Creutzfeldt-Jakob disease (CJD) in humans. The disease has been 
identified in wild and farmed elk and wild deer populations.
CWD has been found in cervid populations in certain areas of Wisconsin, 
Colorado, Nebraska, Wyoming, Kansas, Montana, Oklahoma, South Dakota, 
New Mexico, Minnesota, and Canada. In 1999, the World Health 
Organization said there is no evidence that CWD transmits to humans. 
However, it also suggested any part of a deer or elk believed to be 
diseased should not be eaten. Results of some studies using in vitro 
techniques have suggested that transmission to humans could possibly 
occur. However, if it does occur, it is likely to be through a very 
inefficient process.
Currently, there are no validated analytical tests to identify animals 
in the preclinical phase of CWD, or any other TSE. In addition, no test 
exists to ensure food safety. CWD typically exhibits a long incubation 
period, during which time animals appear normal but are potentially 
infectious. Therefore, FDA is proposing to require that food or 
cosmetic products derived from animals exposed to CWD not enter into 
commerce.

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: Undetermined

Federalism:  Undetermined

Agency Contact: Rebecca Buckner, Consumer Safety Officer, Department of 
Health and Human Services, Food and Drug Administration, Center for 
Food Safety and Applied Nutrition, 5100 Paint Branch Parkway, HFS-366, 
College Park, MD 20740
Phone: 301 436-1486
Fax: 301 436-2632
Email: [email protected]

RIN: 0910-AC21

[[Page 73236]]

_______________________________________________________________________




1083. REQUIREMENTS FOR SUBMISSION OF IN VIVO BIOEQUIVALENCE DATA

Priority: Substantive, Nonsignificant

Legal Authority: 21 USC 321; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 
21 USC 355a; 21 USC 356; 21 USC 356a to 356c; 21 USC 371; 21 USC 374; 
21 USC 379

CFR Citation: 21 CFR 314.96(a)(1); 21 CFR 314.94(a)(7); 21 CFR 
320.21(b)(1)

Legal Deadline: None

Abstract: The Food and Drug Administration (FDA) is proposing to amend 
its regulations on submission of bioequivalence (BE) data to require an 
abbreviated new drug application (ANDA) applicant to submit data from 
all BE studies the applicant conducts on a drug product formulation 
submitted for approval. In the past, ANDA applicants have submitted BE 
studies demonstrating that a generic product meets BE criteria for FDA 
to approve the ANDA but have not typically submitted additional BE 
studies conducted on the same drug product formulation. FDA is 
proposing to require ANDA applicants to submit information, in either a 
complete or summary report, from all additional passing and nonpassing 
BE studies conducted on the same drug product formulation submitted for 
approval.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            10/29/03                    68 FR 61640
Final Action                     To Be                       Determined

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Christine F. Rogers, Regulatory Counsel, Department of 
Health and Human Services, Food and Drug Administration, Center for 
Drug Evaluation and Research, 5515 Security Lane, Suite 1101, 
Rockville, MD 20857
Phone: 301 594-2041
Fax: 301 827-5562

RIN: 0910-AC23
_______________________________________________________________________




1084. FOOD LABELING: TRANS FATTY ACIDS IN NUTRITION LABELING: CONSUMER 
RESEARCH TO CONSIDER NUTRIENT CONTENT AND HEALTH CLAIMS AND POSSIBLE 
FOOTNOTE OR DISCLOSURE STATEMENTS

Priority: Other Significant

Legal Authority: 21 USC 321; 21 USC 343; 21 USC 371

CFR Citation: 21 CFR 101

Legal Deadline: None

Abstract: The Food and Drug Administration issued an advance notice of 
proposed rulemaking on July 11, 2003 (68 FR 41507), to solicit 
information and data that potentially could be used to establish new 
nutrient content claims about trans fatty acids; to establish 
qualifying criteria for trans fat in current nutrient content claims 
for saturated fat and cholesterol, lean and extra lean claims, and 
health claims that contain a message about cholesterol-raising lipids; 
and, in addition, to establish disclosure and disqualifying criteria to 
help consumers make heart-healthy food choices. The Agency also 
requested comments on whether it should consider statements about trans 
fat, either alone or in combination with saturated fat and cholesterol, 
as a footnote in the Nutrition Facts panel or as a disclosure statement 
in conjunction with claims to enhance consumers' understanding about 
such cholesterol-raising lipids and how to use the information to make 
healthy food choices. Information and data obtained from comments and 
from consumer studies that will be conducted by FDA also may be used to 
help draft a proposed rule that would establish criteria for certain 
nutrient content or health claims or require the use of a footnote, or 
other labeling approach, about one or more cholesterol-raising lipids 
in the Nutrition Facts panel to assist consumers in maintaining healthy 
dietary practices.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

ANPRM                           07/11/03                    68 FR 41507
ANPRM Comment Period End        10/09/03
ANPRM Comment Period Reopened 
for 45 days                     03/01/04                     69 FR 9559
ANPRM Comment Period Extended 
for Additional 60 days          04/19/04                    69 FR 20838
ANPRM Comment Period End        06/18/04
NPRM                             To Be                       Determined

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Federal

Agency Contact: Julie Moss, Consumer Safety Officer, Department of 
Health and Human Services, Food and Drug Administration, HFS-830, 
Center for Food Safety and Applied Nutrition, 5100 Paint Branch 
Parkway, College Park, MD 20740
Phone: 301 436-2373
Fax: 301 436-2639
Email: [email protected]

Related RIN: Related to 0910-AB66
RIN: 0910-AC50
_______________________________________________________________________




1085. FOOD STANDARDS: GENERAL PRINCIPLES AND FOOD STANDARDS 
MODERNIZATION

Priority: Other Significant

Legal Authority: 21 USC 321; 21 USC 336; 21 USC 341; 21 USC 343; 21 USC 
371

CFR Citation: 21 CFR 130.5

Legal Deadline: None

Abstract: In 1995, the FDA and FSIS reviewed their regulatory 
procedures and requirements for food standards to determine whether any 
were still needed, and if so, which ones should be modified or 
streamlined. To request public comment to assist them in their review 
of the need for food standards, both Agencies published advance notices 
of proposed rulemaking (ANPRMs) on food standards in December 1995 (60 
FR 47453 and 60 FR 67492). These ANPRMs discussed the Agencies' 
regulations and policy governing food standards, the history of food 
standards, and the possible need to revise the food standards. Several 
comments in response to the ANPRMs recommended that the Agencies 
establish general principles or a fundamental philosophy for reviewing 
food standards and revising them. The Agencies agreed with these 
comments and determined that it would be appropriate to develop general 
principles for reviewing and revising food standards regulations. The 
Agencies also agreed with the comments that stated that the Agencies 
should work in concert to develop

[[Page 73237]]

consistent food standards regulations. FDA and FSIS proposed a set of 
general principles that define how modern food standards should be 
structured (70 FR 29214, May 20, 2005). If this proposed rule is 
adopted, FDA and FSIS will require that a citizen petition for 
establishing, revising, or eliminating a food standard in 21 CFR parts 
130 to 169 and 9 CFR part 319 be submitted in accordance with the 
general principles. Conversely, the Agencies may find deficient a 
petition to establish, revise, or eliminate a food standard that does 
not follow these general principles.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

ANPRM                           12/29/95                    60 FR 67492
ANPRM Comment Period End        04/29/96
NPRM                            05/20/05                    70 FR 29214
NPRM Comment Period End         08/18/05
Final Action                     To Be                       Determined

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: Undetermined

Agency Contact: Ritu Nalubola, Staff Fellow, Department of Health and 
Human Services, Food and Drug Administration, Center for Food Safety 
and Applied Nutrition, Harvey Wiley Building, 5100 Paint Branch 
Parkway, College Park, MD 20740
Phone: 301 436-2371
Fax: 301 436-2636
Email: [email protected]

Related RIN: Related to 0583-AC72
RIN: 0910-AC54
_______________________________________________________________________




1086. CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PROCESSING, 
PACKING, OR HOLDING OF DRUGS; REVISION OF CERTAIN LABELING CONTROLS

Priority: Substantive, Nonsignificant. Major status under 5 USC 801 is 
undetermined.

Unfunded Mandates: Undetermined

Legal Authority: 21 USC 351

CFR Citation: 21 CFR 211.122

Legal Deadline: None

Abstract: The proposed rule would amend the packaging and labeling 
control provisions of the current good manufacturing practice 
regulations for human and veterinary drug products by limiting the 
application of special control procedures for the use of cut labeling 
to immediate container labels, individual unit cartons, or multiunit 
cartons containing immediate containers that are not packaged in 
individual unit cartons. The proposal would also permit the use of any 
automated technique, including differentiation by labeling size and 
shape, that physically prevents incorrect labeling from being processed 
by labeling and packaging equipment when cut labeling is used.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            07/29/97                    62 FR 40489
Final Action                     To Be                       Determined

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected:  Businesses

Government Levels Affected: None

Federalism:  Undetermined

Agency Contact: Howard P. Muller, Office of Regulatory Policy, 
Department of Health and Human Services, Food and Drug Administration, 
Center for Drug Evaluation and Research, 5515 Security Lane, Suite 1101 
(HFD-7), Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562
Email: [email protected]

RIN: 0910-AF08
_______________________________________________________________________




1087. HEALTH CLAIMS

Priority: Other Significant

Unfunded Mandates: Undetermined

Legal Authority: 21 USC 343; 21 USC 371

CFR Citation: Not Yet Determined

Legal Deadline: None

Abstract: On November 25, 2003 (68 FR 66040), FDA issued an advance 
notice of proposed rulemaking (ANPRM) to request comments on 
alternatives for regulating qualified health claims in the labeling of 
conventional human foods and dietary supplements. FDA also solicited 
comments on various other issues related to health claims and on the 
appropriateness and nature of dietary guidance statements on 
conventional food and dietary supplement labels. This ANPRM was 
signaled in the July 11, 2003 (68 FR 41387) notice that announced the 
availability of the final report of the FDA Task Force on the Consumer 
Health Information for Better Nutrition Initiative.
Comments on the regulatory alternatives and additional topics 
identified in the ANPRM will inform FDA decisions about regulation of 
qualified health claims.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

ANPRM                           11/25/03                    68 FR 66040
ANPRM Comment Period Extended   01/27/04                     69 FR 3868
ANPRM Comment Period End        02/25/04
NPRM                             To Be                       Determined

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: None

Federalism:  Undetermined

Agency Contact: Julie Moss, Consumer Safety Officer, Department of 
Health and Human Services, Food and Drug Administration, HFS-830, 
Center for Food Safety and Applied Nutrition, 5100 Paint Branch 
Parkway, College Park, MD 20740
Phone: 301 436-2373
Fax: 301 436-2639
Email: [email protected]

RIN: 0910-AF09
_______________________________________________________________________




1088. COCHINEAL EXTRACT AND CARMINE LABEL DECLARATION

Priority: Other Significant

Legal Authority: 21 USC 379e(b)

CFR Citation: 21 CFR 73.100(d); 21 CFR 73.2087(c); 21 CFR 101.22(k)

Legal Deadline: None

Abstract: The Agency published a proposed rule on January 30, 2006, to 
require the label declaration of all foods and cosmetics containing the 
color additives cochineal extract and carmine in order to protect 
consumers with allergies to these additives. This proposal was issued 
in response to adverse event reports received by FDA and to a citizen 
petition submitted to FDA. The comment period ended on May 1, 2006. FDA 
intends to issue a final rule after reviewing comments.

[[Page 73238]]

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            01/30/06                     71 FR 4839
NPRM Comment Period End         05/01/06
Final Action                     To Be                       Determined

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Mical E. Honigfort, Consumer Safety Officer, Department 
of Health and Human Services, Food and Drug Administration, HFS-265, 
5100 Paint Branch Parkway, College Park, MD 20740
Phone: 301 436-1278
Fax: 301 436-2972
Email: [email protected]

RIN: 0910-AF12
_______________________________________________________________________




1089. FOOD LABELING; PROMINENCE OF CALORIES

Priority: Other Significant

Legal Authority: 21 USC 321; 21 USC 343; 21 USC 371

CFR Citation: 21 CFR 101.9

Legal Deadline: None

Abstract: In response to the Report of the Working Group on Obesity 
(OWG) that FDA issued on March 12, 2004, the Agency issued on April 4, 
2005, an advance notice of proposed rulemaking (ANPRM) in its efforts 
to combat the Nation's obesity problem. The ANPRM requested comments on 
ways to give more prominence to ``calories'' on the food label.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

ANPRM                           04/04/05                    70 FR 17008
ANPRM Comment Period End        06/20/05
NPRM                             To Be                       Determined

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Federalism:  Undetermined

Agency Contact: Jill Kevala, Chemist, Department of Health and Human 
Services, Food and Drug Administration, HFS-830, Center for Food Safety 
and Applied Nutrition, 5100 Paint Branch Parkway, College Park, MD 
20740
Phone: 301 436-1450
Fax: 301 436-2636
Email: [email protected]

RIN: 0910-AF22
_______________________________________________________________________




1090. FOOD LABELING; SERVING SIZES OF PRODUCTS THAT CAN REASONABLY BE 
CONSUMED AT ONE EATING OCCASION; UPDATING OF REFERENCE AMOUNTS 
CUSTOMARILY CONSUMED; APPROACHES FOR RECOMMENDING SMALLER PORTION SIZES

Priority: Other Significant

Legal Authority: 21 USC 321; 21 USC 343; 21 USC 371

CFR Citation: 21 CFR 101.9; 21 CFR 101.12; 21 CFR 101.60(b)

Legal Deadline: None

Abstract: In response to the Report of the Working Group on Obesity 
that FDA issued on March 12, 2004, the Agency issued on April 4, 2005, 
an advance notice of proposed rulemaking (ANPRM) in its efforts to 
combat the Nation's obesity problem. The ANPRM requested comments on 
changes to the Agency's nutrition labeling regulations on serving size 
and comments on allowance of truthful, nonmisleading, and useful 
approaches for promoting consumption of smaller portion sizes.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

ANPRM                           04/04/05                    70 FR 17010
ANPRM Comment Period End        06/20/05
NPRM                             To Be                       Determined

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Federalism:  Undetermined

Agency Contact: Mary Brandt, Supervisor Team Leader, Department of 
Health and Human Services, Food and Drug Administration, HFS-840, 5100 
Paint Branch Parkway, College Park, MD 20740
Phone: 301 436-1788
Fax: 301-436-2635
Email: [email protected]

RIN: 0910-AF23
_______________________________________________________________________




1091. SUBSTANCES PROHIBITED FROM USE IN ANIMAL FOOD OR FEED

Priority: Other Significant

Legal Authority: 21 USC 321; 21 USC 342; 21 USC 343; 21 USC 348; 21 USC 
371

CFR Citation: 21 CFR 589.2001

Legal Deadline: None

Abstract: On October 6, 2005, the Food and Drug Administration (FDA) 
proposed to amend its regulations to prohibit the use of certain cattle 
origin materials in the food or feed of all animals to help strengthen 
existing safeguards to prevent the spread of bovine spongiform 
encephalopathy (BSE) in U.S. cattle. The discovery of a BSE-positive 
dairy cow in December 2003 has caused FDA to review its policies for 
prevention of BSE which resulted in this rulemaking.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

ANPRM                           07/14/04                    69 FR 42288
ANPRM Comment Period End        08/13/04
NPRM                            10/06/05                    70 FR 58569
NPRM Comment Period End         12/20/05
Final Action                     To Be                       Determined

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Burt Pritchett, Biologist, Department of Health and 
Human Services, Food and Drug Administration, Center for Veterinary 
Medicine, HFV-222, 7519 Standish Place, MPN-4, Rockville, MD 20855
Phone: 240 453-6860
Fax: 240 453-6882
Email: [email protected]

RIN: 0910-AF46
_______________________________________________________________________




1092. USE OF MATERIALS DERIVED FROM CATTLE IN HUMAN FOOD AND COSMETICS

Priority: Other Significant

Legal Authority: 21 USC 342; 21 USC 361; 21 USC 371

CFR Citation: 21 CFR 189.5; 21 CFR 700.27

Legal Deadline: None

Abstract: On July 14, 2004, FDA issued an interim final rule (IFR), 
effective

[[Page 73239]]

immediately, to prohibit the use of certain cattle material, to address 
the potential risk of bovine spongiform encephalopathy (BSE), in human 
food, including dietary supplements, and cosmetics. Prohibited cattle 
materials under the IFR include specified risk materials, small 
intestine of all cattle, material from nonambulatory disabled cattle, 
material from cattle not inspected and passed for human consumption, 
and mechanically separated (MS) (Beef). Specified risk materials are 
the brain, skull, eyes, trigeminal ganglia, spinal cord, vertebral 
column (excluding the vertebrae of the tail, the transverse processes 
of the thoracic and lumbar vertebrae, and the wings of the sacrum), and 
dorsal root ganglia of cattle 30 months and older; and the tonsils and 
distal ileum of the small intestine of all cattle. Prohibited cattle 
materials do not include tallow that contains no more than 0.15 percent 
hexane-insoluble impurities and tallow derivatives. This action 
minimizes human exposure to materials that scientific studies have 
demonstrated are highly likely to contain the BSE agent in cattle 
infected with the disease. Scientists believe that the human disease 
variant Creutzfeldt-Jakob disease (vCJD) is likely caused by the 
consumption of products contaminated with the agent that causes BSE. 
After reviewing comments received to the interim final rule, FDA 
intends to issue a final rule.
On September 7, 2005, FDA amended the IFR to permit the use of small 
intestine in human food and cosmetics if it is effectively removed from 
the distal ileum. The amendment also clarified that milk and milk 
products, hides, and tallow derivatives are not prohibited for use in 
human food and cosmetics.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              07/14/04                    69 FR 42256
Interim Final Rule Comment 
Period End                      10/12/04
Interim Final Rule (Ammendments)09/07/05                    70 FR 53063
Final Action                     To Be                       Determined

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Morris E. Potter, Lead Scientist for Epidemiology, 
Department of Health and Human Services, Food and Drug Administration, 
Center for Food Safety and Applied Nutrition, HFS-032, 60 Eighth St., 
NE., Atlanta, GA 30309
Phone: 404 253-1225
Fax: 404-253-1218
Email: [email protected]

RIN: 0910-AF47
_______________________________________________________________________


Department of Health and Human Services (HHS)         Completed Actions


Food and Drug Administration (FDA)



_______________________________________________________________________




1093. REVOCATION OF THE STATUS OF SPECIFIC PRODUCTS; GROUP A 
STREPTOCOCCUS

Priority: Info./Admin./Other

CFR Citation: 21 CFR 610.19

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    04/21/06                    71 FR 20533

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Valerie Butler
Phone: 301 827-6210
Fax: 301 827-9434

RIN: 0910-AF20
_______________________________________________________________________




1094. RECORDKEEPING REQUIREMENTS FOR HUMAN FOOD AND COSMETICS 
MANUFACTURED FROM, PROCESSED WITH, OR OTHERWISE CONTAINING MATERIAL FROM 
CATTLE

Priority: Other Significant

CFR Citation: 21 CFR 189.5; 21 CFR 700.27

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    10/11/06                    71 FR 59653

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Rebecca Buckner
Phone: 301 436-1486
Fax: 301 436-2632
Email: [email protected]

RIN: 0910-AF48
_______________________________________________________________________


Department of Health and Human Services (HHS)       Proposed Rule Stage


Health Resources and Services Administration (HRSA)



_______________________________________________________________________




1095. DESIGNATION OF MEDICALLY UNDERSERVED POPULATIONS AND HEALTH 
PROFESSIONAL SHORTAGE AREAS

Priority: Substantive, Nonsignificant

Legal Authority: 42 USC 254b; 42 USC 254e

CFR Citation: 42 CFR 5; 42 CFR 51c

Legal Deadline: None

Abstract: This rule would consolidate the process for designating areas 
of health professional shortage and medical underservice that apply in 
several Department programs, and would improve the criteria for 
designating medically underserved populations and Primary Care Health 
Professional Shortage Areas. This notice of proposed rulemaking (NPRM) 
will address issues raised by comments received in a previous NPRM, 
dated September 1, 1998.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/01/98                    63 FR 46538
Second NPRM                     12/00/06

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

[[Page 73240]]

Agency Contact: Andy Jordan, Chief, Shortage Designation Branch, 
Department of Health and Human Services, Health Resources and Services 
Administration, 5600 Fishers Lane, Room 8C-26, Rockville, MD 20857
Phone: 301 594-0197
Email: [email protected]

RIN: 0906-AA44
_______________________________________________________________________


Department of Health and Human Services (HHS)          Final Rule Stage


Health Resources and Services Administration (HRSA)



_______________________________________________________________________




1096. NATIONAL PRACTITIONER DATA BANK FOR ADVERSE INFORMATION ON 
PHYSICIANS AND OTHER HEALTH CARE PRACTITIONERS: REPORTING ADVERSE AND 
NEGATIVE ACTIONS

Priority: Other Significant

Legal Authority: 42 USC 1396r-2

CFR Citation: 45 CFR 60

Legal Deadline: None

Abstract: Public Law 100-93 amended section 1921 of the Social Security 
Act to require that each State have in effect a system of reporting 
disciplinary licensure actions taken against all licensed health care 
practitioners and entities. It also requires States to report any 
negative action or finding that a peer review organization, private 
accreditation entity, or a State has concluded against a health care 
practitioner or entity. Section 1921 directs the Secretary to provide 
for maximum appropriate coordination in the implementation of these 
reporting requirements with those of the Health Care Quality 
Improvement Act of 1986 (title IV of Pub. L. 99-660). Section 1921 
requirements will be incorporated into the National Practitioner Data 
Bank.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            03/21/06                    71 FR 14135
Final Action                    12/00/06

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: State

Agency Contact: Mark S. Pincus, Director, Division of Practitioner Data 
Banks, Department of Health and Human Services, Health Resources and 
Services Administration, 5600 Fishers Lane, Room 8-103, Rockville, MD 
20857
Phone: 301 443-2300

RIN: 0906-AA57
_______________________________________________________________________




1097. INTESTINES ADDED TO THE DEFINITION OF ORGANS COVERED BY THE RULES 
GOVERNING THE OPERATION OF THE ORGAN PROCUREMENT AND TRANSPLANTATION 
NETWORK (OPTN)

Priority: Other Significant

Legal Authority: 42 USC 274e, sec 301; 42 USC 273 to 274d, sec 371 to 
376; 42 USC 1320b-8, sec 1138

CFR Citation: 42 CFR 121

Legal Deadline: None

Abstract: The Department of Health and Human Services proposes to add 
intestines to the definition of organs covered by the rules governing 
the operation of the OPTN. After a review of intestinal transplants, 
HHS believes that intestines should now be included within the 
definition. The notice of proposed rulemaking provides the history of 
intestinal transplants, the factors that have persuaded HHS of the 
advisability of including intestines within the scope of the 
regulations governing the operation of the OPTN, and the anticipated 
consequences of this proposal.
As the field of intestinal transplantation evolves, it becomes more 
critical that intestinal organ allocation policies keep pace with the 
advances in the field; that policy development include performance 
indicators to assess how well the policies achieve the goals of an 
equitable transplant system; that those policies are enforceable; and 
that patients and physicians have timely access to accurate data that 
will assist them in making decisions regarding intestinal 
transplantation.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            11/23/05                    70 FR 70765
NPRM Comment Period End         01/23/06
Final Rule                      12/00/06

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Dr. Laura St. Martin, Chief Medical Officer, Department 
of Health and Human Services, Health Resources and Services 
Administration, 5600 Fishers Lane, Room 12C-04, Parklawn Bldg., 
Rockville, MD 20857
Phone: 301 443-4423
Email: [email protected]

RIN: 0906-AA62
_______________________________________________________________________




1098. REQUIREMENTS ESTABLISHING A LIMITATION ON ADMINISTRATIVE EXPENSES; 
RYAN WHITE CARE ACT TITLE IV GRANTS FOR COORDINATED SERVICES AND ACCESS 
TO RESEARCH

Priority: Other Significant. Major status under 5 USC 801 is 
undetermined.

Legal Authority: 42 USC 300ff-71

CFR Citation: Not Yet Determined

Legal Deadline: None

Abstract: This rule finalizes the determination to establish a 
limitation on administrative expenses for Ryan White Comprehensive AIDS 
Resources Emergency (CARE) Act title IV Grants for Coordinated Services 
and Access to Research for Women, Infants, Children, and Youth. The 
rule establishes the limitation on administrative expenses as a 
percentage of the grant award, provides guidance on the procedures and 
processes for implementation of the limitation on administrative 
expenses, and clarifies the individual expenses that shall be 
categorized as administrative. The rule specifies the date for 
implementation as grants funded using fiscal year 2005 grant dollars.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            08/12/03                    68 FR 47923
NPRM Comment Period End         09/11/03
Final Rule                      12/00/06

Regulatory Flexibility Analysis Required: No

[[Page 73241]]

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Jose Rafael Morales, Acting Director, Division of 
Community Based Programs, Department of Health and Human Services, 
Health Resources and Services Administration, 5600 Fishers Lane, Room 
7A-21, Rockville, MD 20857
Phone: 301 443-3650
Email: [email protected]

RIN: 0906-AA65
_______________________________________________________________________




1099. NATIONAL VACCINE INJURY COMPENSATION PROGRAM: CALCULATION OF 
AVERAGE COST OF A HEALTH INSURANCE POLICY

Priority: Other Significant

Legal Authority: Section 2115 of the Public Health Service Act, 42 USC, 
300aa-15

CFR Citation: 42 CFR 100, sec 100.2

Legal Deadline: None

Abstract: The Department of Health and Human Services (HHS) is 
proposing to revise the current method for calculating the average cost 
of a health insurance policy, which is an amount deducted from the 
award of compensation in certain cases. According to the Final Rule 
published on June 24, 1992, which established the current calculation, 
``If, over time, the average cost of health insurance, as calculated by 
the method described above, significantly differs from subsequent HIAA 
survey results or other authoritative sources then available, the 
Secretary of HHS will consider appropriate revisions of this rule.`` 57 
FR 28098 (June 24, 1992). When the latest average monthly cost of an 
individual health insurance policy was calculated based on the current 
methodology, it was significantly different from the Kaiser Family 
Foundation/Health Research and Educational Trust average monthly cost 
of an individual health insurance policy for the same time period. 
Therefore, the Secretary is proposing a new methodology to calculate 
the average cost of a health insurance policy.
Subtitle 2 of title XXI of the Public Health Service Act, as enacted by 
the National Childhood Vaccine Injury Act of 1986, as amended, governs 
the National Vaccine Injury Compensation Program (VICP). The VICP, 
administered by the Secretary of Health and Human Services (the 
Secretary) provides that a proceeding for compensation for a vaccine-
related injury or death shall be initiated by service upon the 
Secretary, and the filing of a petition with the United States Court of 
Federal Claims. In some cases, the injured individual may receive 
compensation for future lost earnings, less appropriate taxes and the 
``average cost of a health insurance policy, as determined by the 
Secretary.'' The elements of compensation that may be awarded to a 
successful petitioner are set out in section 2115 of the Public Service 
Act, 42 U.S.C. section 300aa-15. Subsection (a)(3)(B) specifically 
provides for compensation for lost earnings for a person who has 
sustained a vaccine-related injury at age 18 and beyond. The injured 
person would be eligible to receive compensation for loss of earnings, 
after the age of 18, which are calculated on the basis of the average 
gross weekly earnings of workers in the private, non-farm sector, less 
appropriate taxes and the ``average cost of a health insurance policy, 
as determined by the Secretary.'' The wage data are taken from the 
Employment and Earnings survey done by the Department of Labor, Bureau 
of Labor Statistics.
Subsection (a)(3)(A) specifically provides for payment of actual and 
anticipated lost earnings for individuals injured after reaching age 18 
and does not include deductions for taxes and the cost of health 
insurance. This new methodology is expected to result in a more 
accurate reflection of the actual average cost of a health insurance 
policy as compared to the figure reached under the methodology that is 
currently used which results in a number that is too high. Because the 
amount of compensation for lost wages is reduced by this figure for 
some petitioners receiving compensation under the VICP, such 
petitioners are likely to receive a greater amount of compensation if 
the amendment is adopted.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/09/06                    71 FR 33420
Final Action                    12/00/06

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Dr. Geoffrey S. Evans, Acting Director, Division of 
Vaccine Injury Compensation, Department of Health and Human Services, 
Health Resources and Services Administration, Room 11C-26, 5600 Fishers 
Lane, Rockville, MD 20857
Phone: 301 443-6593
Fax: 301 443-8196
Email: [email protected]

RIN: 0906-AA68
_______________________________________________________________________




1100. HEALTHY TOMORROW'S PARTNERSHIP FOR CHILDREN (HTPC) PROGRAM

Priority: Other Significant

Legal Authority: Social Security Act, title V, sec 501(a)(2); Social 
Security Act, title V, sec 502(a)(1); 42 USC 701

CFR Citation: 42 CFR 51(a)

Legal Deadline: None

Abstract: In this rule, the HTPC is proposing to formally add a cost 
participation component to its grant program. This would require the 
grantees to have non-Federal matching funds and/or in-kind resources 
that are equal to or greater than $100,000 in years 2 through 5 of the 
5-year project period. For example, in years 2-5, a project awarded 
$50,000 (i.e., the maximum annual award) of HTPC funds yearly would be 
expected to have, at a minimum, $100,000 in non-Federal matching funds 
each funding year. In this example, the $100,000 must come from 
alternate non-Federal funds, including, but not limited to, 
individuals, corporations, foundations, in-kind resources, or State and 
local agencies. Documentation of matching funds would be required 
(i.e., specific sources, funding level, in-kind contributions).

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/27/05             70 FR 76435--76436
NPRM Comment Period End         02/27/06
Final Rule                      01/00/07

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Jose Belardo, Director, Healthy Tomorrow's Partnership 
for

[[Page 73242]]

Children Program, Department of Health and Human Services, Health 
Resources and Services Administration, 5600 Fishers Lane, Room 18A-55, 
Rockville, MD 20857
Phone: 301 443-0757
Email: [email protected]

RIN: 0906-AA70
_______________________________________________________________________


Department of Health and Human Services (HHS)         Long-Term Actions


Health Resources and Services Administration (HRSA)



_______________________________________________________________________




1101. NATIONAL PRACTITIONER DATA BANK FOR ADVERSE INFORMATION ON 
PHYSICIANS AND OTHER HEALTH CARE PRACTITIONERS: MEDICAL MALPRACTICE 
PAYMENTS REPORTING REQUIREMENTS

Priority: Substantive, Nonsignificant

Legal Authority: 42 USC 11131

CFR Citation: 45 CFR 60.7

Legal Deadline: None

Abstract: This notice of proposed rulemaking (NPRM) proposes to require 
that, in addition to reporting to the National Practitioner Data Bank, 
medical malpractice payments made where physicians or other health care 
practitioners are named in medical malpractice actions or claims, 
judgments, or settlements, payments be reported where they are made for 
the benefit of physicians or other health care practitioners not named 
in the judgments or settlements but who furnished or failed to furnish 
the health care services upon which the actions or claims were based. 
The purpose of this NPRM is to prevent the evasion of the medical 
malpractice payment reporting requirement of the Data Bank through the 
agreement of the parties to a lawsuit to use the corporate health care 
entity to ``shield'' practitioners. It would also require malpractice 
payers, in very limited circumstances, when it is impossible to 
identify the practitioner who furnished or failed to furnish the health 
care services upon which the actions or claims were based, to report 
why the practitioner could not be identified, and to provide the name 
of the corporate health care entity.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/24/98                    63 FR 71255
Second NPRM                      To Be                       Determined

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Mark S. Pincus, Director, Division of Practitioner Data 
Banks, Department of Health and Human Services, Health Resources and 
Services Administration, 5600 Fishers Lane, Room 8-103, Rockville, MD 
20857
Phone: 301 443-2300

RIN: 0906-AA41
_______________________________________________________________________




1102. OPERATION OF THE ORGAN PROCUREMENT AND TRANSPLANTATION NETWORK 
(OPTN)

Priority: Other Significant. Major status under 5 USC 801 is 
undetermined.

Legal Authority: 42 USC 274e, sec 301, 1984; 42 USC 273 to 274d, sec 
371 to 376; 42 USC 1320b-8, sec 1138

CFR Citation: 42 CFR 121

Legal Deadline: None

Abstract: The Department of Health and Human Services (HHS) proposes to 
amend the final rule governing the operation of the OPTN.
This notice of proposed rulemaking provides the legislative and 
regulatory history of the current rule, the factors that persuaded HHS 
of the advisability of amending the final rule governing the operation 
of the OPTN, and the anticipated consequences of this proposal. As 
required rapid changes in response to better understanding of the 
clinical scientific issues have become evident, HHS has determined that 
the current process for approving and enforcing policies must be 
amended.

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Dr. Hui-Hsing Wong, Medical Officer, Department of 
Health and Human Services, Health Resources and Services 
Administration, 5600 Fishers Lane, Mail Stop 16C-17, Parklawn Bldg., 
Rockville, MD 20857
Phone: 301 443-8104
Fax: 301 594-6095
Email: [email protected]

RIN: 0906-AA63
_______________________________________________________________________


Department of Health and Human Services (HHS)         Completed Actions


Health Resources and Services Administration (HRSA)



_______________________________________________________________________




1103. SMALLPOX VACCINE INJURY COMPENSATION PROGRAM: SMALLPOX (VACCINIA) 
VACCINE INJURY TABLE

Priority: Other Significant

CFR Citation: 42 CFR 102

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Rule                      05/24/06                    71 FR 29805

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Paul T. Clark
Phone: 301 443-5255
Email: [email protected]

Related RIN: Related to 0906-AA61
RIN: 0906-AA60
_______________________________________________________________________




1104. SMALLPOX VACCINE INJURY COMPENSATION PROGRAM: ADMINISTRATIVE 
IMPLEMENTATION

Priority: Other Significant

CFR Citation: 42 CFR 102

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Rule                      05/24/06                    71 FR 29808

Regulatory Flexibility Analysis Required: No

[[Page 73243]]

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Paul T. Clark
Phone: 301 443-5255
Email: [email protected]

Related RIN: Related to 0906-AA60
RIN: 0906-AA61
_______________________________________________________________________


Department of Health and Human Services (HHS)          Final Rule Stage


Indian Health Service (IHS)



_______________________________________________________________________




1105. SECTION 506--LIMITATION ON CHARGES FOR SERVICES FURNISHED BY 
MEDICARE-PARTICIPATING INPATIENT HOSPITAL TO INDIANS

Priority: Other Significant

Legal Authority: MMA, sec 506; PL 108-173

CFR Citation: 42 CFR 135, subpart D; 42 CFR 489, subpart B

Legal Deadline: None

Abstract: This provision requires that as a condition of participation 
in the Medicare Program, providers accept payment at rates established 
by the Secretary in regulations as payment in full for services 
provided in an inpatient hospital to American Indians/Alaskan Natives 
(AI/AN) beneficiaries referred or authorized by the Indian Health 
Service, Tribes or Tribal organizations, or Urban Indian Organization 
(I/T/U).

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            04/28/06                    71 FR 25124
NPRM Comment Period End         06/27/06
Final Action                    04/00/07

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Betty Z. Gould, Regulations Officer, Department of 
Health and Human Services, Indian Health Service, 12300 Twinbrook 
Parkway, Suite 450, Rockville, MD 20852
Phone: 301 443-1116
Email: [email protected]

RIN: 0917-AA07
_______________________________________________________________________


Department of Health and Human Services (HHS)       Proposed Rule Stage


National Institutes of Health (NIH)



_______________________________________________________________________




1106. GRANTS FOR RESEARCH PROJECTS

Priority: Substantive, Nonsignificant

Legal Authority: 42 USC 216

CFR Citation: 42 CFR 52

Legal Deadline: None

Abstract: NIH proposes to amend the regulations governing grants for 
research projects by revising the definition of Principal Investigator 
to mean one or more individuals designated by the grantee in the grant 
application and approved by the Secretary, who is or are responsible 
for the scientific and technical direction of the project, rather than 
limiting the role of principal investigator to one single individual 
when that more accurately reflects the management needs of a research 
project.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/00/06

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Jerry Moore, NIH Regulations Officer, Department of 
Health and Human Services, National Institutes of Health, 6011 
Executive Boulevard, Rockville, MD 20852
Phone: 301 496-4606
Fax: 301 402-0169
Email: [email protected]

RIN: 0925-AA42
_______________________________________________________________________




1107. NATIONAL INSTITUTES OF HEALTH LOAN REPAYMENT PROGRAMS

Priority: Substantive, Nonsignificant

Legal Authority: 42 USC 216; 42 USC 288-5a; 42 USC 287c-33; 42 USC 288-
6; 42 USC 288-1; 42 USC 288-3 42 USC 288-5; 42 USC 288-5a ; 42 USC 288-
6

CFR Citation: 42 CFR 68

Legal Deadline: None

Abstract: NIH proposes to issue a single set of regulations to govern 
all of its loan repayment (LRP) authorities. This action will include 
rescinding the current regulations at 42 CFR 68a and at 42 CFR 68c 
replaced by the new consolidated set of LRP regulations. This action 
will also include withdrawing the previously announced planned actions 
concerning NIH LRP authorities.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            01/00/07

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Jerry Moore, NIH Regulations Officer, Department of 
Health and Human Services, National Institutes of Health, 6011 
Executive Boulevard, Rockville, MD 20852
Phone: 301 496-4606
Fax: 301 402-0169
Email: [email protected]

RIN: 0925-AA43
_______________________________________________________________________




1108. NATIONAL LIBRARY OF MEDICINE TRAINING GRANTS

Priority: Substantive, Nonsignificant

Legal Authority: 42 USC 216; 42 USC 286b-3

CFR Citation: 42 CFR 64

Legal Deadline: None

Abstract: NIH proposes to amend the regulations governing National 
Library of Medicine training grants by revising the definition of 
Project Director to

[[Page 73244]]

mean one or more individuals designated by the grantee in the grant 
application and approved by the Secretary, who is or are responsible 
for the scientific and technical direction of the project, rather than 
limiting the role of the project director to one single individual when 
that more accurately reflects the management needs of a research 
project.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            03/00/07

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Jerry Moore, NIH Regulations Officer, Department of 
Health and Human Services, National Institutes of Health, 6011 
Executive Boulevard, Rockville, MD 20852
Phone: 301 496-4606
Fax: 301 402-0169
Email: [email protected]

RIN: 0925-AA44
_______________________________________________________________________




1109. MINORITY BIOMEDICAL RESEARCH SUPPORT PROGRAM

Priority: Substantive, Nonsignificant. Major status under 5 USC 801 is 
undetermined.

Legal Authority: 42 USC 216 42 USC 241(a) (3)

CFR Citation: 42 CFR 52c

Legal Deadline: None

Abstract: NIH proposes to amend the regulations governing Minority 
Biomedical Research Support Program grants by revising the definition 
of Program Director to mean one or more individuals designated by the 
grant application and approved by the Secretary, who is or are 
responsible for the scientific and technical direction of the program, 
rather than limiting the role of the program director to one single 
individual when that more accurately reflects the management needs of a 
research program.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            03/00/07

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Jerry Moore, NIH Regulations Officer, Department of 
Health and Human Services, National Institutes of Health, 6011 
Executive Boulevard, Rockville, MD 20852
Phone: 301 496-4606
Fax: 301 402-0169
Email: [email protected]

RIN: 0925-AA45
_______________________________________________________________________




1110. NATIONAL INSTITUTE OF ENVIRONMENTAL HEALTH SCIENCES HAZARDOUS 
SUBSTANCES BASIC RESEARCH AND TRAINING GRANTS

Priority: Substantive, Nonsignificant

Legal Authority: 42 USC 216; 42 USC 9660(a)

CFR Citation: 42 CFR 65a

Legal Deadline: None

Abstract: NIH proposes to amend the regulations governing National 
Institute of Environmental Health Sciences Hazardous Substances Basic 
Research and Training grants by revising the definition of Program 
Director to mean one or more individuals designated by the grantee in 
the grant application and approved by the Secretary, who is or are 
responsible for the scientific and technical direction of the project, 
rather than limiting the role of the program director to one single 
individual when that more accurately reflects the management needs of a 
research project.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            03/00/07

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Jerry Moore, NIH Regulations Officer, Department of 
Health and Human Services, National Institutes of Health, 6011 
Executive Boulevard, Rockville, MD 20852
Phone: 301 496-4606
Fax: 301 402-0169
Email: [email protected]

RIN: 0925-AA46
_______________________________________________________________________




1111. ENDOWMENT PROGRAM

Priority: Substantive, Nonsignificant

Legal Authority: 42 USC 216; 42 USC 287c-31

CFR Citation: Not Yet Determined

Legal Deadline: None

Abstract: The Director of the National Center for Minority Health and 
Disparities Research is authorized under section 485E(h)(1) of the 
Public Health Service Act to carry out a program to facilitate minority 
health disparities research and other health disparities research by 
providing for research endowments at centers of excellence under 
section 736 (Public Health Service Act). NIH plans to issue 
implementing regulations to govern these research endowments.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/00/06

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Jerry Moore, NIH Regulations Officer, Department of 
Health and Human Services, National Institutes of Health, 6011 
Executive Boulevard, Rockville, MD 20852
Phone: 301 496-4606
Fax: 301 402-0169
Email: [email protected]

RIN: 0925-AA47
_______________________________________________________________________




1112. UNDERGRADUATE SCHOLARSHIP PROGRAM REGARDING PROFESSIONS NEEDED BY 
THE NATIONAL INSTITUTES OF HEALTH

Priority: Substantive, Nonsignificant. Major status under 5 USC 801 is 
undetermined.

Legal Authority: 42 USC 216; 42 USC 288-4

CFR Citation: 42 CFR 68b

Legal Deadline: None

Abstract: Section 487D of the Public Health Service Act, as added by 
NIH Revitalization Act of 1993, creates a program offering scholarships 
to individuals from disadvantaged backgrounds who are enrolled as full-
time students at accredited institutions pursuing academic programs 
appropriate for careers in professions needed by NIH. For each year of 
scholarship support, the recipient agrees to service (employment) after 
graduation, at NIH, for one year. Additionally, the individual agrees 
to at least 10 consecutive weeks of service

[[Page 73245]]

(employment) at NIH during which the individual is attending the 
educational institution and receiving the NIH scholarship. The proposed 
new regulations will govern this program.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            03/00/07

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Jerry Moore, NIH Regulations Officer, Department of 
Health and Human Services, National Institutes of Health, 6011 
Executive Boulevard, Rockville, MD 20852
Phone: 301 496-4606
Fax: 301 402-0169
Email: [email protected]

RIN: 0925-AA48
_______________________________________________________________________




1113. [bull] NIH TRAINING GRANTS

Priority: Substantive, Nonsignificant

Legal Authority: 42 USC 216; 42 USC 285q-1; 42 USC 287c-32

CFR Citation: 42 CFR 63a

Legal Deadline: None

Abstract: NIH plans to amend the agency's existing training grants 
regulations to (1) reflect their applicability to the training 
authorities set forth in PHS's ACT sections 464W and 485F, (2) reflect 
their applicability to the National Center on Minority Health and 
Health Disparities (NCMHD)'s and Fogarty International Center (FIC)'s 
Minority Health and Health Disparities International Research Training 
(MHIRT) awards, and (3) revise the definition of program director to 
mean one or more individuals named by the grantee in the grant 
application and approved by the Secretary, who is responsible for the 
management and conduct of the training program, rather than limiting 
the role of program director to a single individual when that more 
accurately reflects the management needs of a training program.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            03/00/07

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Jerry Moore, NIH Regulations Officer, Department of 
Health and Human Services, National Institutes of Health, 6011 
Executive Boulevard, Rockville, MD 20852
Phone: 301 496-4606
Fax: 301 402-0169
Email: [email protected]

RIN: 0925-AA49
_______________________________________________________________________




1114. [bull] NIH CENTER GRANTS

Priority: Substantive, Nonsignificant

Legal Authority: 42 USC 216; 42 USC 287c-21h; 42 USC 241

CFR Citation: 42 CFR 57a

Legal Deadline: None

Abstract: NIH plans to amend the Agency's existing center grant 
regulations by revising section 52a.1 to reflect the applicability of 
the regulations to (1) The program of research centers on complementary 
and alternative medicine administered by the National Center for 
Complementary and Alternative Medicine (NCCAM), and (2) the regional 
centers of excellence for biodefense and emerging infectious diseases 
research administered by the National Institute of Allergy and 
Infectious Diseases (NIAID).

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            03/00/07

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Jerry Moore, NIH Regulations Officer, Department of 
Health and Human Services, National Institutes of Health, 6011 
Executive Boulevard, Rockville, MD 20852
Phone: 301 496-4606
Fax: 301 402-0169
Email: [email protected]

RIN: 0925-AA50
_______________________________________________________________________




1115. [bull] NIH CONSTRUCTION GRANT

Priority: Substantive, Nonsignificant

Legal Authority: 42 USC 216

CFR Citation: 42 CFR 52b

Legal Deadline: None

Abstract: NIH plans to amend the Agency's existing construction grant 
regulations by revising language concerning recovery set forth in 42 
CFR part 52b(a)(1) and insurance coverage set forth in 42 CFR part 52b, 
10(n) to make the language more consistent with the language set forth 
in the Department's regulations at 45 CFR part 74.32 and 45 CFR part 
74.31, respectively.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            03/00/07

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Jerry Moore, NIH Regulations Officer, Department of 
Health and Human Services, National Institutes of Health, 6011 
Executive Boulevard, Rockville, MD 20852
Phone: 301 496-4606
Fax: 301 402-0169
Email: [email protected]

RIN: 0925-AA51
_______________________________________________________________________


Department of Health and Human Services (HHS)          Final Rule Stage


National Institutes of Health (NIH)



_______________________________________________________________________




1116. STANDARDS FOR A NATIONAL CHIMPANZEE SANCTUARY SYSTEM

Priority: Other Significant

Legal Authority: 42 USC 287a-3a

CFR Citation: 42 CFR 9

Legal Deadline: NPRM, Statutory, June 18, 2001.

Abstract: NIH proposes to establish standards for operating a national 
chimpanzee sanctuary system to provide for the retirement of federally-
owned or supported chimpanzees no longer needed for research.

[[Page 73246]]

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            01/11/05                     70 FR 1843
Final Action                    12/00/06

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Jerry Moore, NIH Regulations Officer, Department of 
Health and Human Services, National Institutes of Health, 6011 
Executive Boulevard, Rockville, MD 20852
Phone: 301 496-4606
Fax: 301 402-0169
Email: [email protected]

RIN: 0925-AA31
_______________________________________________________________________


Department of Health and Human Services (HHS)         Completed Actions


National Institutes of Health (NIH)



_______________________________________________________________________




1117. NATIONAL INSTITUTES OF HEALTH TRAINING GRANTS

Priority: Substantive, Nonsignificant

CFR Citation: 42 CFR 63a

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    06/26/06                    71 FR 42296

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Jerry Moore
Phone: 301 496-4606
Fax: 301 402-0169
Email: [email protected]

RIN: 0925-AA28
_______________________________________________________________________


Department of Health and Human Services (HHS)             Prerule Stage


Office of Public Health and Science (OPHS)



_______________________________________________________________________




1118. HUMAN SUBJECTS PROTECTION REGULATIONS: ADDITIONAL PROTECTIONS FOR 
ADULT INDIVIDUALS WITH IMPAIRED DECISIONMAKING CAPACITY

Priority: Substantive, Nonsignificant. Major status under 5 USC 801 is 
undetermined.

Legal Authority: 5 USC 301; 42 USC 289

CFR Citation: 45 CFR 46

Legal Deadline: None

Abstract: Through this advance notice of proposed rulemaking (ANPRM), 
the Office for Human Research Protections (OHRP), Office of Public 
Health and Science, and the Food and Drug Administration (FDA) of the 
Department of Health and Human Services (HHS) are seeking comment on 
whether it is necessary to develop additional safeguards to help 
protect adult individuals with impaired decisionmaking capacity who are 
potential subjects in research, and if so, suggestions for appropriate 
safeguards. This ANPRM stems from the recommendation of an HHS working 
group, generated in response to the report published by the National 
Bioethics Advisory Commission entitled ``Research Involving Persons 
with Mental Disorders That May Affect Decisionmaking Capacity'' 
(December 1998), and from subsequent recommendations by the National 
Human Research Protections Advisory Committee. The goal of these 
efforts is to maximize the safety and welfare of adult subjects with 
impaired decisionmaking capacity who participate in research supported, 
conducted, or regulated by HHS.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

ANPRM                            To Be                       Determined

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Julie A. Kaneshiro, Department of Health and Human 
Services, Office of Public Health and Science, The Tower Building, 1101 
Wootton Parkway, Suite 200, Rockville, MD 20852
Phone: 240 452-6900
Fax: 301 402-2071
Email: [email protected]

RIN: 0940-AA11
_______________________________________________________________________


Department of Health and Human Services (HHS)          Final Rule Stage


Office of Public Health and Science (OPHS)



_______________________________________________________________________




1119. HUMAN SUBJECTS PROTECTION REGULATIONS: INSTITUTIONAL REVIEW BOARDS 
REGISTRATION REQUIREMENTS

Priority: Substantive, Nonsignificant

Legal Authority: 5 USC 301; 42 USC 289

CFR Citation: 45 CFR 46

Legal Deadline: None

Abstract: This notice of proposed rulemaking proposes to add subpart F 
to Department of Health and Human Services (HHS) regulations for 
protection of human subjects, 45 CFR part 46, to require registration 
of institutional review boards (IRBs) with HHS. The registration 
information would include contact information, approximate numbers of 
active protocols involving research conducted or supported by HHS, 
accreditation status, IRB membership, and staffing for the IRB. The 
proposed registration requirements will make it easier for the Office 
for Human Research Protections (OHRP) to convey information to IRBs, 
and will support the current IRB registration operated by OHRP. Under 
the current OHRP IRB registration

[[Page 73247]]

system, the submission of certain registration information is required 
by human subjects protection regulations, and certain other information 
may be submitted voluntarily. This proposed information collection was 
submitted to the Office of Management and Budget under the Paperwork 
Reduction Act. Under the proposed rule, all registration information 
will be required, making the IRB registration system uniform with IRB 
registration requirements of the Food and Drug Administration (FDA), 
and creating a single, HHS IRB Registration system. FDA simultaneously 
published a proposed rule regarding FDA IRB registration requirements.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            07/04/04                    69 FR 40584
NPRM Comment Period End         10/04/04
Final Action                    04/00/07

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Irene Stith-Coleman Ph.D, Department of Health and 
Human Services, Office of Public Health and Science, The Tower 
Building, 1101 Wootten Parkway, Rockville, MD 20852
Phone: 240 453-6900
Fax: 301 402-2071
Email: [email protected]

RIN: 0940-AA06
_______________________________________________________________________


Department of Health and Human Services (HHS)         Long-Term Actions


Office of Public Health and Science (OPHS)



_______________________________________________________________________




1120. PUBLIC HEALTH SERVICE STANDARDS FOR THE PROTECTION OF RESEARCH 
MISCONDUCT WHISTLEBLOWERS

Priority: Substantive, Nonsignificant

Legal Authority: 42 USC 216; 42 USC 241; 42 USC 289b

CFR Citation: 42 CFR 94

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            11/28/00                    65 FR 70830
NPRM Comment Period End         01/29/01
Final Action                    12/00/07

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Chris Pascal, Director, Office of Research Integrity, 
Department of Health and Human Services, Office of Public Health and 
Science, 1101 Wootten Parkway, Rockville, MD 20852
Phone: 240 453-8200
Fax: 301 443-5351

Related RIN: Related to 0940-AA04
RIN: 0940-AA01
_______________________________________________________________________




1121. HUMAN SUBJECTS PROTECTION REGULATIONS: TRAINING AND ED. 
REQUIREMENTS FOR INSTITUTIONAL OFFICIALS, INSTITUTIONAL REVIEW BOARD 
MEMBERS AND STAFF, HUMAN PROTECTIONS ADMINISTRATORS, AND INVESTIGATORS

Priority: Other Significant. Major status under 5 USC 801 is 
undetermined.

Legal Authority: 5 USC 301; 42 USC 289

CFR Citation: 45 CFR 46

Legal Deadline: None

Abstract: This notice of proposed rulemaking proposes to add subpart E 
to the Department of Health and Human Services (HHS) regulations for 
protection of human subjects, 45 CFR part 46, and would require that 
institutions engaged in human subjects research covered by an assurance 
of compliance filed with the Office for Human Research Protections 
ensure that institutional officials, institutional review board (IRB) 
chairpersons, and human protection administrators receive appropriate 
training and education about the institution's assurance and that IRB 
chairpersons and members, IRB staff, investigators, and other personnel 
involved in the conduct or oversight of human subjects research receive 
appropriate training and education about relevant human subjects 
protection requirements. The proposed training and education 
requirements will help to ensure that responsible individuals at 
assured institutions understand and meet their regulatory 
responsibilities for human subjects protection.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

ANPRM                            To Be                       Determined

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Elyse Summers, Department of Health and Human Services, 
Office of Public Health and Science, The Tower Building, 1101 Wootten 
Parking, Rockville, MD 20852
Phone: 240 453-6900
Email: [email protected]

RIN: 0940-AA08

[[Page 73248]]

_______________________________________________________________________


Department of Health and Human Services (HHS)       Proposed Rule Stage


Centers for Medicare & Medicaid Services (CMS)



_______________________________________________________________________




1122. HOME HEALTH AGENCY (HHA) CONDITIONS OF PARTICIPATION (COPS) (CMS-
3819-P) (SECTION 610 REVIEW)

Priority: Other Significant

Legal Authority: 42 USC 1302; 42 USC 1395x; 42 USC 1395cc(a); 42 USC 
1395hh; 42 USC 1395bb

CFR Citation: 42 CFR 484;409;418

Legal Deadline: None

Abstract: This proposed rule would revise the existing Conditions of 
Participation (CoPs) that Home Health Agencies (HHAs) must meet to 
participate in the Medicare program. The requirements focus on the 
actual care delivered to patients by HHAs, reflect an interdisciplinary 
view of patient care, allow HHAs greater flexibility in meeting quality 
standards, and eliminate unnecessary procedural requirements. These 
changes are an integral part of our efforts to achieve broad-based 
improvements and measurements of the quality of care furnished through 
Federal programs while at the same time reducing procedural burdens on 
providers.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            03/10/97                    62 FR 11005
NPRM Comment Period End         06/09/97
Second NPRM                     05/00/07

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses, Organizations

Government Levels Affected: None

Agency Contact: Lieutenant Scott Cooper, Health Insurance Specialist, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, Clinical Standards Group, Mailstop S3-05-15, 7500 
Security Boulevard, Baltimore, MD 21244
Phone: 410 786-9465
Email: [email protected]

Commander Mercedes Benitez-McCray, Health Insurance Specialist, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, Clinical Standards Group, Mailstop S3-05-14, 7500 
Security Boulevard, Baltimore, MD 21244
Phone: 410 786-5716
Email: [email protected]

RIN: 0938-AG81
_______________________________________________________________________




1123. APPEALS OF CMS OR CONTRACTOR DETERMINATIONS WHEN A PROVIDER OR 
SUPPLIER FAILS TO MEET THE REQUIREMENTS FOR MEDICARE BILLING (CMS-6003-
P2)

Priority: Substantive, Nonsignificant

Legal Authority: 42 USC 1302; 42 USC 1395u(b)(3)(C); 42 USC 1395ff(b) 
and 1395hh

CFR Citation: 42 CFR 405.874; 42 CFR 424.525; 42 CFR 424.535; 42 CFR 
424.545; 42 CFR 498.1; 42 CFR 498.2; 42 CFR 498.5; 42 CFR 498.22; 42 
CFR 498.40; 42 CFR 498.44; 42 CFR 498.56; 42 CFR 498.78; 42 CFR 498.79; 
42 CFR 498.86; 42 CFR 498.89; . . .

Legal Deadline: None

Abstract: This proposed rule would extend appeal rights to all 
suppliers whose enrollment applications for Medicare billing privileges 
are disallowed by a carrier or whose Medicare billing privileges are 
revoked, except for those suppliers covered under other existing 
appeals provisions of our regulations. In addition, certain appeal 
provisions are revised to correspond with the existing appeal 
provisions in those other sections of our regulations. The rule would 
also extend appeal rights to all suppliers not covered by existing 
regulations to ensure they have a full and fair opportunity to be 
heard. This rule would incorporate provisions from section 936 of the 
Medicare Modernization Act.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            10/25/99                    64 FR 57431
Second NPRM                     03/00/07

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: August Nemec, Health Insurance Specialist, Department 
of Health and Human Services, Centers for Medicare & Medicaid Services, 
Mailstop C3-02-16, 7500 Security Boulevard, Baltimore, MD 21244-1850
Phone: 410 786-0612
Email: [email protected]

RIN: 0938-AI49
_______________________________________________________________________




1124. RURAL HEALTH CLINICS: AMENDMENTS TO PARTICIPATION REQUIREMENTS AND 
PAYMENT PROVISIONS AND ESTABLISHMENT OF A QUALITY ASSESSMENT AND 
IMPROVEMENT PROGRAM (CMS-1910-P2)

Priority: Other Significant

Legal Authority: 42 USC 1302; 42 USC 1395hh

CFR Citation: 42 CFR 405; 42 CFR 491

Legal Deadline: None

Abstract: This rule proposes to amend the Medicare certification and 
payment requirements for rural health clinics (RHCs), as required by 
section 4205 of the Balanced Budget Act of 1997. It proposes to change 
the definition of a qualifying rural shortage area in which a Medicare 
RHC must be located; establish criteria for identifying RHCs essential 
to delivery of primary care services that we can continue to approve as 
Medicare RHCs in areas no longer designated as medically underserved; 
and limit nonphysician practitioner staffing requirements. This rule 
proposes to impose payment limits on provider-based RHCs and prohibit 
the use of RHC space, professional staff, equipment, and other RHC 
resources by another Medicare entity. The rule also proposes to require 
RHCs to establish a quality assessment and performance improvement 
program. In light of the fact that section 902 of MMA of 2003 requires 
the Secretary to issue regulations within 3 years, CMS is republishing 
the provisions of the final RHC rule as a proposed rule to provide the 
public with an opportunity to formally comment on the new policies 
established under the December 24, 2003 rule. In addition, we are 
proposing new policy revisions to the RHC and FQHC program to improve 
and strengthen this rural safety net benefit.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/24/03                    68 FR 74792
Interim Final Rule              09/22/06                    71 FR 55341
Interim Final Rule Comment 
Period End                      11/21/06
Second NPRM                     02/00/07

Regulatory Flexibility Analysis Required: No

[[Page 73249]]

Small Entities Affected: Businesses

Government Levels Affected: Federal

Agency Contact: Amy Bassano, Director, Division of Ambulatory Services, 
Hospital and Ambulatory Policy Group, Department of Health and Human 
Services, Centers for Medicare & Medicaid Services, Mailstop C4-02-14, 
7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-3028
Email: [email protected]

RIN: 0938-AJ17
_______________________________________________________________________




1125. USE OF RESTRAINTS AND SECLUSION IN MEDICARE AND MEDICAID 
PARTICIPATING FACILITIES THAT PROVIDE INPATIENT OR RESIDENTIAL CARE 
(CMS-2130-P)

Priority: Other Significant

Legal Authority: PL 106-554, (BIPA 2000 of the Children's Health Act)

CFR Citation: 45 CFR 101; 42 CFR 418; 42 CFR 482; 42 CFR 483; 42 CFR 
485

Legal Deadline: None

Abstract: This proposed rule would implement provisions of the 
Children's Health Act of 2000 (CHA) related to the use of restraints or 
seclusion for individuals receiving services in health care facilities 
that receive Federal funding. The rule would establish common 
terminology and basic expectations for the use of restraints and 
seclusion for health care facilities that furnish inpatient or 
residential care and receive Medicare or Medicaid funding.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            02/00/07

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected:  Businesses

Government Levels Affected: Undetermined

Federalism:  Undetermined

Agency Contact: Carla McGregor, Health Insurance Specialist, Survey and 
Certification Group, Department of Health and Human Services, Centers 
for Medicare & Medicaid Services, Mailstop S2-11-27, 7500 Security 
Boulevard, Baltimore, MD 21244-1850
Phone: 410 786-0663
Email: [email protected]

RIN: 0938-AL26
_______________________________________________________________________




1126. REVISIONS TO CONDITIONS FOR COVERAGE FOR AMBULATORY SURGICAL 
CENTERS (CMS-3887-P)

Priority: Other Significant. Major under 5 USC 801.

Legal Authority: Not Yet Determined

CFR Citation: None

Legal Deadline: None

Abstract: This proposed rule would revise the ambulatory surgical 
center conditions for coverage to reflect current innovations in 
healthcare delivery, quality assessment, and performance improvement. 
The focus would be to improve outcomes of health care and satisfaction 
for Medicare beneficiaries, while streamlining structural and 
procedural requirements when possible.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/00/07

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: State

Agency Contact: Joan Brooks, Health Insurance Specialist, Department of 
Health and Human Services, Centers for Medicare & Medicaid Services, 
Clinical Standards Group, Mailstop S3-02-01, 7500 Security Boulevard, 
Baltimore, MD 21244
Phone: 410 786-5526
Email: [email protected]

Commander Jacqueline Morgan, Health Insurance Specialist, Department of 
Health and Human Services, Centers for Medicare & Medicaid Services, 
Clinical Standards and Group, Mailstop S3-02-01, 7500 Security 
Boulevard, Baltimore, MD 21244
Phone: 410 786-4282
Email: [email protected]

RIN: 0938-AL80
_______________________________________________________________________




1127. MODIFICATIONS TO ELECTRONIC TRANSACTIONS AND CODE SETS (CMS-0009-
P)

Priority: Other Significant. Major status under 5 USC 801 is 
undetermined.

Unfunded Mandates: Undetermined

Legal Authority: Sec 1171 to 1179 of the Social Security Act

CFR Citation: Not Yet Determined

Legal Deadline: None

Abstract: This proposed rule would streamline the adoption process for 
electronic transactions and code set standards mandated by the Health 
Insurance Portability and Accountability Act of 1996, and provide 
certain other technical corrections and clarifications to the 
regulations.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/00/07

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected:  Businesses, Governmental Jurisdictions, 
Organizations

Government Levels Affected: Federal, Local, State, Tribal

Federalism:  This action may have federalism implications as defined in 
EO 13132.

Agency Contact: Gladys C. Wheeler, Health Insurance Specialist, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, Office of E-Health Standards and Services, Mail Stop 
S2-24-18, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-0273
Email: [email protected]

RIN: 0938-AM50
_______________________________________________________________________




1128. REQUIREMENTS FOR LONG-TERM CARE FACILITIES: HOSPICE SERVICES (CMS-
3140-P)

Priority: Other Significant

Unfunded Mandates: Undetermined

Legal Authority: 42 USC 1395i-3; 42 USC 1396r

CFR Citation: 42 CFR 483

Legal Deadline: None

Abstract: This proposed rule establishes requirements that long-term 
care (LTC) facilities must have an agreement with hospice agencies when 
hospice care is provided in a long-term care facility to participate in 
the Medicare and Medicaid programs. We are proposing these new 
requirements to ensure that quality hospice care is provided to 
eligible residents.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            02/00/07

[[Page 73250]]

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Anita Panicker, Health Insurance Specialist, Department 
of Health and Human Services, Centers for Medicare & Medicaid Services, 
Clinical Standards Group, Mailstop S3-02-01, 7500 Security Boulevard, 
Baltimore, MD 21244
Phone: 410 786-5646
Fax: 410 786-8532
Email: [email protected]

RIN: 0938-AM87
_______________________________________________________________________




1129. REVISIONS TO HIPAA CODE SETS (CMS-0013-P)

Priority: Economically Significant. Major under 5 USC 801.

Unfunded Mandates: Undetermined

Legal Authority: PL 104-191

CFR Citation: 45 CFR 162

Legal Deadline: None

Abstract: This proposed rule would revise some of the adopted 
transaction and code set standards detailed in regulations published by 
HHS on August 17, 2000, and February 20, 2003.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            03/00/07

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses, Governmental Jurisdictions, 
Organizations

Government Levels Affected: Federal, Local, State, Tribal

Federalism:  This action may have federalism implications as defined in 
EO 13132.

Energy Effects:  Statement of Energy Effects planned as required by 
Executive Order 13211.

Agency Contact: Gladys Wheeler, Health Insurance Specialist, Office of 
E-Health Standards and Services, Department of Health and Human 
Services, Centers for Medicare & Medicaid Services, Mailstop S2-26-17, 
7500 Security Boulevard, Baltimore, MD 21244-1850
Phone: 410 786-0273
Email: [email protected]

RIN: 0938-AN25
_______________________________________________________________________




1130. NATIONAL PLAN AND PROVIDER ENUMERATION SYSTEM (NPPES) DATA 
DISSEMINATION (CMS-6060-NC)

Priority: Other Significant

Legal Authority: HIPAA of 1996, secs 1171 to 1179 of the Social 
Security Act (42 USC 1329d to 1320d-8); NPI final rule (01/23/2004); 
NPS System of Records (07/28/1998)

CFR Citation: 45 CFR 163

Legal Deadline: None

Abstract: The National Provider Identifier final rule, published 
January 23, 2004, stated that CMS would publish a follow-up notice to 
describe the data dissemination processes and any applicable charges 
for data. This notice with comment period describes the data that would 
be available from the National Plan and Provider Enumeration System 
(NPPES), in compliance with the provisions of the Privacy Act, the 
Freedom of Information Act, the Electronic Freedom of Information Act 
(FOIA) Amendments of 1996, and other applicable regulations and 
authorities, and must be consistent with the National Provider System 
of Records Notice published on July 28, 1998. The notice describes the 
data dissemination strategy, processes, and any applicable charges for 
data.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Notice                          01/00/07

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Patrica Peyton, Health Insurance Specialist, Department 
of Health and Human Services, Centers for Medicare & Medicaid Services, 
Office of Financial Management, Program Integrity Group, Mailstop C3-
02-16, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-1812
Email: [email protected]

RIN: 0938-AN71
_______________________________________________________________________




1131. CHANGES TO THE DISCLOSURE OF INFORMATION REQUIREMENTS FOR QUALITY 
IMPROVEMENT ORGANIZATIONS (CMS-3156-P)

Priority: Other Significant. Major status under 5 USC 801 is 
undetermined.

Legal Authority: Sec 1154 to 1160 of the Social Security Act

CFR Citation: Not Yet Determined

Legal Deadline: None

Abstract: This proposed rule would add a provision to the existing 
Quality Improvement Organization (QIO) confidentiality regulations 
allowing the release of Medicare beneficiary-specific information, with 
patient consent, from the QIO to practitioners and providers in a 
treatment relationship with the beneficiary. This release may only be 
permitted after the beneficiary has consented to the release and has 
been provided notice of the release. The new provisions will also 
permit the release of Medicare beneficiary-specific information, with 
patient consent, from the QIO to other QIOs, subcontractors to QIOs, 
and CMS for educational and quality improvement purposes. Additionally, 
the rule would add provisions for the Medicare beneficiary complaint 
system that is required by the statute and administered by the QIOs.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/00/07

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Captain Arnold C. Farley, Health Insurance Specialist, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, Office of Clinical Standards and Quality, 
Improvement Group, Mail Stop S3-02-01, 7500 Security Boulevard, 
Baltimore, MD 21244-1850
Phone: 410 786-1154
Email: [email protected]

RIN: 0938-AN73

[[Page 73251]]

_______________________________________________________________________




1132. FIRE SAFETY REQUIREMENTS FOR LONG-TERM CARE FACILITIES: SPRINKLER 
SYSTEMS (CMS-3191-P)

Priority: Other Significant

Legal Authority: 42 USC 1302; 42 USC 1395hh

CFR Citation: 42 CFR 483

Legal Deadline: None

Abstract: This proposed rule would require all long-term care 
facilities to be equipped with sprinkler systems. This proposed rule 
requests public comment, including comment on the duration of a phase-
in period, to allow long-term care facilities to install such systems.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            10/27/06                    71 FR 62957
NPRM Comment Period End         12/26/06
Final Action                    10/00/09

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Danielle N. Shearer, Health Insurance Specialist, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, Clinical Standards Group, Mailstop S3-02-01, 7500 
Security Boulevard, Baltimore, MD 21244
Phone: 410 786-6617
Fax: 410 786-8532
Email: [email protected]

RIN: 0938-AN79
_______________________________________________________________________




1133. PAYMENTS FOR SERVICE PROVIDED WITHOUT CHARGE (CMS-2489-P)

Priority: Other Significant. Major status under 5 USC 801 is 
undetermined.

Unfunded Mandates: Undetermined

Legal Authority: None

CFR Citation: 42 CFR 435

Legal Deadline: None

Abstract: The proposed rule would clarify that Federal Financial 
Participation (FFP) is not available to States on behalf of Medicaid 
beneficiaries for Medicaid-covered services provided without charge 
(that is, free care) to individuals receiving the services. Free care 
means a particular service is available without charge to an individual 
who receives the service or to any third party on behalf of the 
individual.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            01/00/07

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected:  Governmental Jurisdictions

Government Levels Affected: Undetermined

Federalism:  Undetermined

Agency Contact: Melissa L. Harris, Health Insurance Specialist, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, Disability & Elderly Health Programs Group, Mailstop 
S2-14-26, 7500 Security Boulevard, Baltimore, MD 21244-1850
Phone: 410 786-3397
Email: [email protected]

RIN: 0938-AO07
_______________________________________________________________________




1134. MEDICAL IMPROVEMENT ELIGIBILITY GROUP AND DEFINITION OF WORK (CMS-
2143-P)

Priority: Other Significant

Legal Authority: PL 105-33 sec 4733 Balanced Budget Act of 1997; PL 
106-170 sec 201 Ticket to Work and Work Incentives Improvement Act of 
1999

CFR Citation: 42 CFR 435. 238; 42 CFR 436.232

Legal Deadline: None

Abstract: In order to provide health services to employed individuals 
whose medical conditions have improved to the point where they are no 
longer eligible for disability benefits, this proposed rule would 
provide a definition of ``medically determinable severe impairment'' 
under the Ticket to Work and Work Incentives Improvement Act of 1999 
(Ticket to Work). Under this definition, States can determine 
eligibility standards for the Medical Improvement Group authorized 
under the Ticket to Work law, thereby permitting individuals to retain 
their Medicaid coverage. Additionally, this proposed rule would give 
States offering Medicaid buy-in programs for employed individuals with 
disabilities the option of selecting a minimum work standard for 
participation.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            07/00/07

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: State

Agency Contact: Carey Appold, Technical Director, Disabled & Elderly 
Health Programs Group, Div. of Advocacy and Special Issues, Department 
of Health and Human Services, Centers for Medicare & Medicaid Services, 
Center for Medicaid and State Operations, Mailstop S2-14-26, 7500 
Security Boulevard, Baltimore, MD 21244-1850
Phone: 410 786-2117
Fax: 410 786-9004
Email: [email protected]

RIN: 0938-AO10
_______________________________________________________________________




1135. OUTPATIENT HOSPITAL SERVICES AND RURAL HEALTH CLINIC SERVICES 
AMENDMENT (CMS-2213-P)

Priority: Economically Significant. Major under 5 USC 801.

Legal Authority: sec 1102 of the Social Security Act

CFR Citation: 42 CFR 440.20

Legal Deadline: None

Abstract: This rule would amend the definition of outpatient hospital 
services for the Medicaid program. The purpose of this amendment is to 
clarify the scope of services available for Federal financial 
participation (FFP) under the outpatient hospital services benefit 
category.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/00/07

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected:  Businesses

Government Levels Affected: None

Federalism:  Undetermined

Agency Contact: Jeremy Silanskis, Health Insurance Specialist, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, Center for Medicaid and State Operations, Mailstop 
S3-13-15, 7500 Security Boulevard, Baltimore, MD 21244-1850

[[Page 73252]]

Phone: 410 786-1592
Fax: 410 786-8533
Email: [email protected]

RIN: 0938-AO17
_______________________________________________________________________




1136. MEDICAID PRESCRIPTION DRUGS -- AVERAGE MANUFACTURER PRICE (CMS-
2238-P)

Priority: Other Significant. Major status under 5 USC 801 is 
undetermined.

Legal Authority: 42 USC 1396r.8; Deficit Reduction Act of 2005, PL 109-
171, sec 6001 to 6003

CFR Citation: 42 CFR 447.535

Legal Deadline: Final, Statutory, January 1, 2007.

Abstract: This proposed rule would implement sections 6001, 6002, and 
6003 of the Deficit Reduction Act of 2005. This rule would set the 
Federal upper reimbursement limit (FUL) as 250 percent of the average 
manufacturer price (AMP) for drugs on the FUL list, and would clarify 
the requirements and manner in which AMPs are determined for multiple 
source drugs and other drug payment revisions. This rule would also 
list the physician administered multiple source drugs that the 
Secretary determines have the highest dollar volume of dispensing in 
Medicaid and would require manufacturers to include authorized generics 
when they report their AMP and best price for covered outpatient drugs 
to the Secretary.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/00/06

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: State

Agency Contact: Yolanda Lashawn Reese, Health Insurance Specialist, 
Division of Benefits and Coverage Policy Services, Department of Health 
and Human Services, Centers for Medicare & Medicaid Services, Center 
for Medicaid and State Operations, Mailstop S2-06-15, 7500 Security 
Boulevard, Baltimore, MD 21244-1850
Phone: 410 786-9898
Fax: 410 786-5882
Email: [email protected]

RIN: 0938-AO20
_______________________________________________________________________




1137. USE OF REPAYMENT PLANS (CMS-6032-P)

Priority: Other Significant

Legal Authority: Section 1893(i)(1) of the Social Security Act as 
amended by sec 935(i)(1) of Medicare Modernization Act (MMA)

CFR Citation: 42 CFR 401.601, 42 CFR 401.607

Legal Deadline: Final, Statutory, December 9, 2003.

Abstract: This proposed rule would modify Medicare regulations to 
implement a provision of the Medicare Prescription Drug, Improvement, 
and Modernization Act of 2003 pertaining to the use of repayment plans 
(also known as extended repayment schedules). Under this provision, we 
propose to grant a provider or a supplier an extended repayment 
schedule under certain terms and conditions as defined in the statute. 
The proposed rule would establish criteria and procedures to apply this 
requirement and to define the concepts of ``hardship'' and ``extreme 
hardship.''

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/00/06

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Thomas A. Noplock, Health Insurance Specialist, 
Division of Medicare Overpayments, Office of Financial Management, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, Financial Services Group, Mailstop C3-15-01, 7500 
Security Boulevard, Baltimore, MD 21244-1850
Phone: 410 786-3378
Fax: 410 786-7030
Email: [email protected]

RIN: 0938-AO27
_______________________________________________________________________




1138. REDISTRIBUTION OF UNEXPENDED STATE CHILDREN'S HEALTH INSURANCE 
PROGRAM (SCHIP) FUNDS FROM THE APPROPRIATION FOR FISCAL YEAR 2004 (CMS-
2241-NC)

Priority: Other Significant

Legal Authority: 42 USC 1397dd(g); 42 USC 1397ee(g); secs 2104(e) & (f) 
of the Social Security Act

CFR Citation: 42 CFR 457.600-630

Legal Deadline: None

Abstract: This notice announces the procedure for redistribution of 
States' unexpended FY 2004 allotments that remained at the end of FY 
2004 to those States that fully expended the FY 2004 SCHIP allotment. 
These redistributed allotments will be available through the end of FY 
2007.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            03/00/07

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: Undetermined

Federalism:  Undetermined

Agency Contact: Richard Strauss, Technical Director, Finance Systems & 
Budget Group, Department of Health and Human Services, Centers for 
Medicare & Medicaid Services, Centers for Medicaid and State 
Operations, Mailstop, C5-22-25, 7500 Security Boulevard, Baltimore, MD 
21244-1850
Phone: 410 786-2019
Email: [email protected]

RIN: 0938-AO28
_______________________________________________________________________




1139. PROSPECTIVE PAYMENT SYSTEM FOR LONG-TERM CARE HOSPITALS RY 2008: 
ANNUAL PAYMENT RATE UPDATES (CMS-1529-P)

 Regulatory Plan: This entry is Seq. No. 44 in part II of this issue of 
the Federal Register.

RIN: 0938-AO30
_______________________________________________________________________




1140. HOME HEALTH PROSPECTIVE PAYMENT SYSTEM RATE UPDATE FOR CALENDAR 
YEAR 2008 (CMS-1541-P)

Priority: Economically Significant. Major under 5 USC 801.

Legal Authority: Social Security Act, sec 1102 and 1871; (42 USC 1302 
and 1395 (hh))

CFR Citation: 42 CFR 484

Legal Deadline: Final, Statutory, January 1, 2008.

Abstract: This proposed rule would update the 60-day national episode 
rate and the national per-visit rate amounts

[[Page 73253]]

under the Medicare Prospective Payment System for home health agencies, 
effective January 1, 2008. This rule would also propose the first major 
refinement to the HHPPS since its implementation on October 1, 2001.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            05/00/07

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Randy L. Throndset, Technical Advisor, Department of 
Health and Human Services, Centers for Medicare & Medicaid Services, 
Mailstop C5-02-03, 7500 Security Boulevard, Baltimore, MD 21244-1850
Phone: 410 786-0131
Email: [email protected]

RIN: 0938-AO32
_______________________________________________________________________




1141. GYNECOLOGICAL CYTOLOGY PROFICIENCY TESTING REQUIREMENTS FOR 
LABORATORIES, INDIVIDUALS, AND PROFICIENCY TESTING PROGRAM APPROVALS 
(CMS-2252-P)

Priority: Other Significant

Legal Authority: 42 USC 263a, Clinical Laboratory Improvement 
Amendments of 1988; 42 USC 1395x secs 1861s(15) through 1861s(17)

CFR Citation: 42 CFR 493

Legal Deadline: None

Abstract: This proposed rule would revise certain participation 
requirements for clinical laboratories offering cytology services and 
individuals examining gynecological cytology specimens; and CMS-
approval requirements for programs offering proficiency testing for 
gynecologic cytology under the Clinical Laboratory Improvement 
Amendments (CLIA) of 1988 program. Evaluating the competency of each 
individual who examines gynecologic cytology specimens (pap smears) is 
required by Federal law and regulations. Failure to publish this rule 
could result in the failure to identify individuals who cannot 
competently and accurately examine pap smears, or failure to 
demonstrate a need for continual education. Identifying these 
individuals is essential in providing quality patient care.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            07/00/07

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected:  Businesses

Government Levels Affected: None

Federalism:  Undetermined

Agency Contact: Cheryl B. Wiseman, Health Insurance Specialist, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, Centers for Medicare & Medicare Services, Mailstop, 
S2-12-25, 7500 Security Boulevard, Baltimore, MD 21244-1850
Phone: 410 786-3340
Email: [email protected]

RIN: 0938-AO34
_______________________________________________________________________




1142. STATE OPTION TO ESTABLISH NON-EMERGENCY MEDICAL TRANSPORTATION 
PROGRAM (CMS-2234-P)

Priority: Other Significant

Unfunded Mandates: Undetermined

Legal Authority: Deficit Reduction Act of 2005 (PL 109-171), sec 6083

CFR Citation: Not Yet Determined

Legal Deadline: Final, Statutory, February 8, 2006.

Abstract: Enactment of section 6083 of the Deficit Reduction Act of 
2005 (DRA amends section 1902(a)of the Social Security Act (the Act) by 
adding a new section 1902(a)(70) that provides States with the ability 
to establish, under the State plan, a non-emergency medical 
transportation (NEMT) brokerage program. Such a program may be managed 
through a contract with a broker(s), as a method of assuring NEMT 
services for beneficiaries who need access to medical care, but have no 
other means of transportation. A regulation is needed in order to 
implement this provision of the DRA.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            02/00/07

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Federalism:  Undetermined

Agency Contact: Jean Sheil, Director, Family and Children's Health 
Programs Group, Department of Health and Human Services, Centers for 
Medicare & Medicaid Services, Center for Medicaid State Operations, 
Mailstop S2-01-16, 7500 Security Boulevard, Baltimore, MD 21244-1850
Phone: 410 786-5647
Fax: 410-786-8534
Email: [email protected]

RIN: 0938-AO45
_______________________________________________________________________




1143. COST SHARING OPTIONS (CMS-2244-P)

Priority: Other Significant. Major status under 5 USC 801 is 
undetermined.

Unfunded Mandates: Undetermined

Legal Authority: Deficit Reduction Act of 2005, PL 109-171

CFR Citation: Not Yet Determined

Legal Deadline: Final, Statutory, March 31, 2006, sec 6041 and 6042.
Final, Statutory, January 1, 2007, sec 6043.

Abstract: This rule would incorporate sections 6041, 6042, and 6043 of 
the Deficit Reduction Act of 2005 (DRA), which provides State Medicaid 
agencies with increased flexibility to implement premium and cost 
sharing requirements for certain Medicaid recipients. This authority is 
in addition to the current authority States already had under section 
1916 of the Social Security Act to implement premiums and cost sharing. 
Sections 6041, 6042, and 6043 of the DRA provide States with additional 
State plan flexibility to implement alternative premiums for certain 
recipients and to implement alternative cost sharing for certain 
medical services, particularly non-preferred drugs and non-emergency 
care furnished in a hospital emergency department.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            02/00/07

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Federalism:  Undetermined

Agency Contact: Jean Sheil, Director, Family and Childrens Health 
Programs Group, Department of Health and Human Services, Centers for 
Medicare & Medicaid Services, Centers for Medicaid State Operations, 
Mailstop

[[Page 73254]]

S2-01-16, 7500 Security Boulevard, Baltimore, MD 21244-1850
Phone: 410 786-5647
Fax: 410 786-8534
Email: [email protected]

RIN: 0938-AO47
_______________________________________________________________________




1144. STATE FLEXIBILITY FOR MEDICAID BENEFIT PACKAGES (CMS-2232-P)

Priority: Economically Significant. Major under 5 USC 801.

Unfunded Mandates: Undetermined

Legal Authority: Deficit Reduction Act of 2005; sec 6044; sec 1102 of 
the Social Security Act

CFR Citation: 42 CFR 440.300; 440, 385

Legal Deadline: Final, Statutory, March 31, 2006.

Abstract: Enactment of section 6044 of the Deficit Reduction Act of 
2005 (DRA) responds to State requests for additional flexibility by 
providing States with new options. For non-disabled, non-elderly 
persons who are eligible for Medicaid, the DRA allows States to follow 
the lead established by SCHIP and provide more flexible benefit 
packages that are more comparable to those in the private sector. 
Benchmark coverage is one of four types of coverage: Blue Cross/Blue 
Shield standard FEHBP coverage; State employee coverage; coverage of 
the largest commercial HMO in the states; and Secretary approved 
coverage. Children under age 19 enrolled in a benchmark plan will 
continue to receive EPSDT benefits through wrap-around coverage. A 
regulation is needed in order to implement this provision of the DRA.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            02/00/07

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Federalism:  Undetermined

Agency Contact: Jean Sheil, Director, Family and Children's Health 
Programs Group, Department of Health and Human Services, Centers for 
Medicare & Medicaid Services, Center for Medicaid State Operations, 
MailStop S2-01-16, 7500 Security Boulevard, Balitimore, MD 21244
Phone: 410 786-5647
Email: [email protected]

RIN: 0938-AO48
_______________________________________________________________________




1145. HOME AND COMMUNITY-BASED SERVICES (HCBS) STATE PLAN OPTION (CMS-
2249-P)

Priority: Other Significant. Major status under 5 USC 801 is 
undetermined.

Unfunded Mandates: Undetermined

Legal Authority: Deficit Reduction Act of 2005; (PL 109-171), sec 6086

CFR Citation: Not Yet Determined

Legal Deadline: Final, Statutory, January 1, 2007.

Abstract: The regulation would offer guidance to States on implementing 
the statutory provisions of section 6086 of the Deficit Reduction Act.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            04/00/07

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Federalism:  Undetermined

Agency Contact: Theresa Pratt, Director, Division of Integrated Health 
Systems, Disabled and Elderly Health Programs Group, Department of 
Health and Human Services, Centers for Medicare & Medicaid Services, 
Center for Medicaid State Operations, Mailstop S2-14-26, 7500 Security 
Boulevard, Baltimore, MD 21244
Phone: 410 786-9499
Email: [email protected]

RIN: 0938-AO53
_______________________________________________________________________




1146. [bull] MEDICARE PART D DATA (CMS-4119-P)

Priority: Other Significant

Legal Authority: 1860 D-15 of the Social Security Act

CFR Citation: 42 CFR 423

Legal Deadline: None

Abstract: CMS is required by Congress to conduct a number of Part D 
related research demonstration and evaluation studies that require Part 
D claims data. We are requesting that plans, on a voluntary basis, 
provide CMS with their approval to use claims and beneficiary risk 
score data for these studies to be conducted by CMS staff and 
contractors to better operate and/or improve the Medicare Part D 
program.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            10/18/06                    71 FR 61445
NPRM Comment Period End         12/18/06
Final Action                    10/00/09

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected:  Organizations

Government Levels Affected: None

Agency Contact: Alissa M. Deboy, Acting Division Director, Center for 
Beneficiary Choices, Department of Health and Human Services, Centers 
for Medicare & Medicaid Services, Drug Plan Policy and Analysis 
Division, Mailstop C1-26-16, 7500 Security Boulevard, Baltimore, MD 
21244-1850
Phone: 410 786-6041
Email: [email protected]

RIN: 0938-AO58
_______________________________________________________________________




1147. [bull] PROSPECTIVE PAYMENT SYSTEM FOR INPATIENT REHABILITATION 
FACILITIES FOR FY 2008 (CMS-1551-P)

Priority: Economically Significant. Major under 5 USC 801.

Legal Authority: SSA, sec 1886(i); PL 105-33; PL 106-554; PL 106-113

CFR Citation: 42 CFR 412

Legal Deadline: Final, Statutory, August 1, 2007.

Abstract: This proposed rule would update rates for the prospective 
payment system for inpatient rehabilitation facilities for FY 2008.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            05/00/07

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Agency Contact: Bill Ullman, Division Director DHHS, CMS, Center for 
Medicare Management, Department of Health and Human Services, Centers 
for Medicare & Medicaid Services, C5-06-24, 7500 Security Blvd, 
Baltimore, MD 21244
Phone: 410 786-5667

[[Page 73255]]

Email: [email protected]

RIN: 0938-AO63
_______________________________________________________________________




1148. [bull] PROSPECTIVE PAYMENT SYSTEM AND CONSOLIDATED BILLING FOR 
SKILLED NURSING FACILITIES--UPDATE FOR FY 2008 (CMS-1545-P)

Priority: Economically Significant. Major under 5 USC 801.

Legal Authority: Social Security Act, sec 1888(e)

CFR Citation: 42 CFR 424

Legal Deadline: Final, Statutory, July 31, 2007.

Abstract: This rule proposes updates to the payment rates used under 
the SNF PPS beginning 10/1/07.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            05/00/07

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Agency Contact: William Ullman, Health Insurance Specialist, Centers 
for Medicare Management, Department of Health and Human Services, 
Centers for Medicare & Medicaid Services, Chronic Care Policy Group, 
Mailstop C5-07-08, 7500 Security Blvd, Baltimore, MD 21244
Phone: 410 786-5667
Email: [email protected]

RIN: 0938-AO64
_______________________________________________________________________




1149. [bull] REVISIONS TO PAYMENT POLICIES UNDER THE PHYSICIAN FEE 
SCHEDULE FOR CALENDAR YEAR 2008 (CMS-1385-P)

Priority: Economically Significant. Major under 5 USC 801.

Unfunded Mandates: Undetermined

Legal Authority: Social Security Act, sec 1102; Social Security Act, 
sec 1871

CFR Citation: 42 CFR 405; 42 CFR 410; 42 CFR 411; 42 CFR 413; 42 CFR 
414; 42 CFR 426

Legal Deadline: Final, Statutory, November 1, 2007.

Abstract: This rule would make several changes affecting Medicare Part 
B payment.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            08/00/07

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Federalism:  Undetermined

Agency Contact: Diane S. Milstead, Health Insurance Specialist, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, Centers for Medicaid Management, Mailstop C4-03-06, 
7500 Security Blvd, Baltimore, MD 21244
Phone: 410 786-3355
Email: [email protected]

RIN: 0938-AO65
_______________________________________________________________________




1150. [bull] STANDARDS FOR E-PRESCRIBING UNDER MEDICARE PART D (CMS-
0016-P)

 Regulatory Plan: This entry is Seq. No. 45 in part II of this issue of 
the Federal Register.

RIN: 0938-AO66
_______________________________________________________________________




1151. [bull] EXEMPTION OF PRIVACY ACT DISCLOSURE OF CERTAIN 
INVESTIGATIVE MATERIALS (CMS-0029-P)

Priority: Info./Admin./Other

Legal Authority: 5 USC 301; 5 USC 552a.45 CFR s 5b.11(b) (2)(ii)(H)

CFR Citation: 45 CFR 5b

Legal Deadline: None

Abstract: Unrestricted disclosure of confidential information in CMS 
files can impede ongoing investigations, invade the personal privacy of 
individuals, reveal the identities of confidential sources, or 
otherwise impair the ability of CMS to conduct investigations. For 
these reasons this rule proposes to exempt the ASPEN Complaint/Incident 
Tracking System (ACTS), Organ Procurement Organizations Systems (OPOS), 
Fraud Investigation Database (FID), and HIPAA Information Tracking 
System (HITS) from the notification, access, correction and amendment 
provisions of the Privacy Act concerning records compiled for law 
enforcement purposes.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            02/00/07

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: Undetermined

Federalism:  Undetermined

Agency Contact: Katherine Marie Brewer, Health Insurance Specialist, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, Mail Stop N2-04-27, 7500 Security Boulevard, 
Baltimore, MD 21244-1850
Phone: 410 786-7235
Fax: 410-786-5636
Email: [email protected]

RIN: 0938-AO69
_______________________________________________________________________




1152. [bull] CHANGES TO THE HOSPITAL INPATIENT PROSPECTIVE PAYMENT 
SYSTEMS AND FY 2008 RATES (CMS-1533-P)

 Regulatory Plan: This entry is Seq. No. 46 in part II of this issue of 
the Federal Register.

RIN: 0938-AO70
_______________________________________________________________________




1153. [bull] CHANGES TO THE HOSPITAL OUTPATIENT PROSPECTIVE PAYMENT 
SYSTEM AND CALENDAR YEAR 2008 PAYMENT RATES (CMS-1392-P)

Priority: Economically Significant. Major under 5 USC 801.

Legal Authority: BBA; BBRA; BIPA; MMA; DRA of 2005; . . .

CFR Citation: 42 CFR 419 to 485

Legal Deadline: Final, Statutory, November 1, 2007.

Abstract: This proposed rule would revise the Medicare hospital 
outpatient prospective payment system to implement applicable statutory 
requirements and changes arising from our continuing experience with 
this system and to implement certain related provisions of the Medicare 
Prescription Drug, Improvement, and Modernization Act (MMA) of 2003. In 
addition, the proposed rule describes proposed changes to the amounts 
and factors used to determine the payment rates for Medicare hospital 
outpatient services paid under the prospective

[[Page 73256]]

payment system. These changes would be applicable to services furnished 
on or after 1/1/08.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            08/00/07

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: Federal

Federalism:  This action may have federalism implications as defined in 
EO 13132.

Agency Contact: Alberta Dwivedi, Health Insurance Specialist, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, Mailstop C3-24-23, 7500 Security Boulevard, 
Baltimore, MD 21244-1850
Phone: 410 786-0763
Email: [email protected]

RIN: 0938-AO71
_______________________________________________________________________




1154. [bull] HOSPICE WAGE INDEX FOR FY 2008 (CMS-1539-P)

Priority: Other Significant

Legal Authority: 1814(i)(1) and 1814(i)(2)

CFR Citation: 42 CFR 418

Legal Deadline: Final, Statutory, October 1, 2007.

Abstract: This rule proposes the annual update to the hospice wage 
index for FY 2008. The wage index is used to reflect local differences 
in wage levels. The hospice wage index methodology and values are based 
on recommendations of a negotiated rulemaking advisory committee and 
were originally published on 8/8/97.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Notice                          04/00/07

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected:  Businesses

Government Levels Affected: Undetermined

Federalism:  Undetermined

Agency Contact: Terri Deutsch, Health Insurance Specialist, Department 
of Health and Human Services, Centers for Medicare & Medicaid Services, 
Division of Community Post Acute Care, Hospital and Ambulatory Policy 
Group, Mailstop C5-08-18, 7500 Security Blvd, Baltimore, MD 21244
Phone: 410 786-9462
Email: [email protected]

RIN: 0938-AO72
_______________________________________________________________________




1155. [bull] SPECIAL ENROLLMENT PERIOD AND MEDICARE PREMIUM CHANGES 
(CMS-4129-P)

Priority: Other Significant. Major under 5 USC 801.

Legal Authority: PL 109-171, sec 5115; PL 108-173, sec 811

CFR Citation: 42 CFR 406 to 408; 20 CFR 418

Legal Deadline: Final, Statutory, January 1, 2007.

Abstract: Section 5115 of the Deficit Reduction Act of 2005 (DRA) 
provides a special enrollment period for Medicare Part B/premium Part A 
and waiver of late enrollment penalty and for individuals who are 
serving as a volunteer outside the United States through a program that 
covers at least a 12-month period and who have health insurance while 
providing the voluntary service outside of the United States. Section 
811 of the Medicare Prescription Drug, Drug, Improvement, and 
Modernization Act (MMA) of 2003 as amended by section 5111 of the DRA 
requires an additional amount be assessed to the Part B premium of 
individuals who have a modified adjusted gross income that reaches 
certain levels. The effective date for these provisions is 1/1/07. 
Since SSA has the responsibility for calculating the additional premium 
amount, SSA will explain this statutory requirement in its part of the 
regulations (20 CFR 418). CMS will include a reference to the SSA 
regulation in its change to 42 CFR 408.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            07/00/07

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Sam DellaVecchia, Health Insurance Specialist, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-4481
Email: [email protected]

RIN: 0938-AO77
_______________________________________________________________________




1156. [bull] REVISIONS TO THE MEDICARE ADVANTAGE AND PART D PRESCRIPTION 
DRUG CONTRACT CONFIDENTIALITY AND DISCLOSURE, DETERMINATIONS, APPEALS, 
AND INTERMEDIATE SANCTIONS PROCESSES (CMS-4124-P)

 Regulatory Plan: This entry is Seq. No. 47 in part II of this issue of 
the Federal Register.

RIN: 0938-AO78
_______________________________________________________________________


Department of Health and Human Services (HHS)          Final Rule Stage


Centers for Medicare & Medicaid Services (CMS)



_______________________________________________________________________




1157. HOSPITAL CONDITIONS OF PARTICIPATION: LABORATORY SERVICES (CMS-
3014-IFC) (SECTION 610 REVIEW)

Priority: Substantive, Nonsignificant

Legal Authority: 42 USC 1302; 42 USC 1395hh

CFR Citation: 42 CFR 482

Legal Deadline: None

Abstract: This interim final rule with comment period requires 
hospitals that transfuse blood and blood products to prepare and follow 
written procedures for appropriate action when it is determined that 
blood and blood products the hospital received and transfused are at 
increased risk for transmitting hepatitis C virus (HCV); quarantine 
prior collections from a donor who is at increased risk for 
transmitting HCV infection; notify transfusion recipients, as 
appropriate, of the need for HCV testing and

[[Page 73257]]

counseling; and maintain records for at least 10 years.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            11/16/00                    65 FR 69416
Interim Final Rule              01/00/07

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Mary Collins, Health Insurance Specialist, Department 
of Health and Human Services, Centers for Medicare & Medicaid Services, 
Clinical Standards Group, Mailstop S3-02-01, 7500 Security Boulevard, 
Baltimore, MD 21244
Phone: 410 786-3189
Email: [email protected]

RIN: 0938-AJ29
_______________________________________________________________________




1158. USE OF RESTRAINTS AND SECLUSION IN RESIDENTIAL TREATMENT 
FACILITIES PROVIDING INPATIENT PSYCHIATRIC SERVICES TO INDIVIDUALS UNDER 
AGE 21 (CMS-2065-F)

Priority: Other Significant

Legal Authority: 42 USC 1302; 42 USC 1396d

CFR Citation: 42 CFR 441, 42 CFR 442, and 42 CFR 483

Legal Deadline: None

Abstract: This rule addresses standards of practice that residential 
treatment facilities providing inpatient psychiatric services for 
individuals under age 21 must meet with regard to the use of restraints 
(including psychoactive drugs) and seclusion.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              01/22/01                     66 FR 7148
60-Day Delay of Effective Date 
To 05/22/2001                   03/21/01                    66 FR 15800
Interim Final Rule Comment 
Period End                      03/23/01
Interim Final Rule Effective    03/23/01
Interim Final Rule Amendment 
with Clarification              05/22/01                    66 FR 28110
Interim Final Rule Comment 
Period End                      07/23/01
Final Action                    05/00/07

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Thomas Shenk, Health Insurance Specialist, Department 
of Health and Human Services, Centers for Medicare & Medicaid Services, 
Division of Benefits & Coverage Policy, Mailstop S2-14-26, 7500 
Security Boulevard, Baltimore, MD 21244-1850
Phone: 410 786-3295
Email: [email protected]

RIN: 0938-AJ96
_______________________________________________________________________




1159. PHYSICIANS' REFERRALS TO HEALTH CARE ENTITIES WITH WHICH THEY HAVE 
FINANCIAL RELATIONSHIPS (CMS-1810-F)

Priority: Other Significant

Legal Authority: 42 USC 1877

CFR Citation: 42 CFR 411; 42 CFR 424

Legal Deadline: Final, Statutory, March 26, 2007, MMA sec. 902.

Abstract: This rule finalizes certain statutory provisions that prevent 
payment for services and impose penalties when a physician makes a 
referral to an entity in which that physician has a financial interest, 
unless an exception applies. It also addresses comments received on the 
``Phase II'' Stark regulation published in the Federal Register on 
March 26, 2004.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              03/26/04                    69 FR 16054
Interim Final Rule Comment 
Period End                      06/24/04
Correction Notice               04/06/04                    69 FR 17933
Second Correction Notice        09/24/04                    69 FR 57226
Final Action                    03/00/07

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses, Organizations

Government Levels Affected: None

Agency Contact: Linda P. Howard, Health Insurance Specialist, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, Center for Medicare Management, Chronic Care Policy 
Group, Mailstop C4-25-02, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-5255
Email: [email protected]

RIN: 0938-AK67
_______________________________________________________________________




1160. PROVIDER REIMBURSEMENT DETERMINATIONS AND APPEALS (CMS-1727-F)

Priority: Substantive, Nonsignificant

Legal Authority: Sec 1878 of the Social Security Act

CFR Citation: 42 CFR 405

Legal Deadline: Final, Statutory, June 25, 2007, MMA sec. 902.

Abstract: This final rule redefines, clarifies, and updates the 
guidelines and procedures for Provider Reimbursement Review Board 
appeals, based on recent court decisions.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/25/04                    69 FR 35716
NPRM Comment Period End         08/24/04
Final Action                    06/00/07

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Morton Marcus, Health Insurance Specialist, Department 
of Health and Human Services, Centers for Medicare & Medicaid Services, 
Mailstop C4-25-02, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-4477
Email: [email protected]

RIN: 0938-AL54
_______________________________________________________________________




1161. REVISED CIVIL MONEY PENALTIES, ASSESSMENTS, EXCLUSIONS, AND 
RELATED APPEALS PROCEDURES (CMS-6146-F)

Priority: Substantive, Nonsignificant. Major status under 5 USC 801 is 
undetermined.

Unfunded Mandates: Undetermined

Legal Authority: Not Yet Determined

CFR Citation: 42 CFR 402

Legal Deadline: Final, Statutory, July 23, 2007, MMA sec. 902.

Abstract: This final rule revises the CMS civil money penalty 
authorities.

[[Page 73258]]

These revisions are intended to add the specific exclusion sanction 
authorities as established in the procedures for imposing civil money 
penalties, assessments, and exclusions for certain violations of the 
Medicare and Medicaid programs. This rule also finalizes an August 4, 
2005, rule that outlines the process for health care providers to 
follow if they wish CMS to request a waiver of exclusion on their 
behalf.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            07/23/04                    69 FR 43956
Final Action                    07/00/07

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Agency Contact: Joel Cohen, Health Insurance Specialist, Department of 
Health and Human Services, Centers for Medicare & Medicaid Services, 
Office of Financial Management, C3-04-06, 7500 Security Boulevard, 
Baltimore, MD 21244-1850
Phone: 410 786-3349

Related RIN: Related to 0938-AN48
RIN: 0938-AM98
_______________________________________________________________________




1162. ENHANCED DSH TREATMENT FOR CERTAIN HOSPITALS (CMS-2198-F)

Priority: Other Significant

Legal Authority: Section 1923(a)(2)(D)of the Social Security Act

CFR Citation: 42 CFR 447; 42 CFR 455

Legal Deadline: Final, Statutory, December 8, 2003, Sec 1001(d) of MMA.

Abstract: This rule implements section 1001(d) of the Medicare 
Prescription Drug Improvement, and Modernization Act of 2003, which 
requires States to report additional information about their 
disproportionate share hospital (DSH) programs in their annual report. 
This section also requires States to independently audit and submit 
these certified audits annually to the Secretary.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            08/26/05                    70 FR 50262
Final Action                    04/00/07

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: State

Agency Contact: James Frizzera, Director, National Institutional 
Payment Policy Center for Medicaid and State Operations, Department of 
Health and Human Services, Centers for Medicare & Medicaid Services, 
Mailstop S3-13-15, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-3263
Email: [email protected]

RIN: 0938-AN09
_______________________________________________________________________




1163. COMPETITIVE ACQUISITION FOR CERTAIN DURABLE MEDICAL EQUIPMENT 
(DME), PROSTHETICS, ORTHOTICS, AND SUPPLIES (CMS-1270-F)

 Regulatory Plan: This entry is Seq. No. 48 in part II of this issue of 
the Federal Register.

RIN: 0938-AN14
_______________________________________________________________________




1164. NONDISCRIMINATION IN HEALTH COVERAGE IN THE GROUP MARKET (CMS-
4081-F)

Priority: Other Significant

Legal Authority: 42 USC 300gg

CFR Citation: 45 CFR 146.121

Legal Deadline: None

Abstract: This final rule governs the provisions prohibiting 
discrimination based on a health factor for group health plans and 
issuers of health insurance coverage offered in connection with a group 
health plan. The rules contained in this document implement changes 
made to the Internal Revenue Code of 1986, the Employee Retirement 
Income Security Act of 1974, and the Public Health Service Act enacted 
as part of the Health Insurance Portability and Accountability Act of 
1996. It also addresses comments we received on the Bonafide Wellness 
Plan proposed rule.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              04/08/97                    62 FR 16894
Interim Final Rule Comment 
Period End                      07/17/97
Interim Final Rule Effective    07/17/97
Interim Final Rule              01/08/01                     66 FR 1378
Interim Final Rule Effective    03/09/01
Interim Final Rule Comment 
Period End                      04/09/01
Final Action                    12/00/06

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses, Governmental Jurisdictions

Government Levels Affected: Local, State

Agency Contact: Adam Shaw, Health Insurance Specialist, Department of 
Health and Human Services, Centers for Medicare & Medicaid Services, 
Center for Beneficiary Choices, Employer & Policy Operations Group, 
7500 Security Boulevard, Baltimore, MD 21244-1850
Phone: 410 786-1091
Email: [email protected]

Karen Levin, Health Insurance Specialist, Department of Health and 
Human Services, Centers for Medicare & Medicaid Services, Center for 
Beneficiary Choices, Employer & Policy Operations Group, 7500 Security 
Boulevard, Baltimore, MD 21244-1850
Phone: 410 786-5445
Email: [email protected]

Related RIN: Previously reported as 0938-AK19
RIN: 0938-AN29
_______________________________________________________________________




1165. HOSPITAL CONDITIONS OF PARTICIPATION: PATIENTS' RIGHTS (CMS-3018-
F)

Priority: Other Significant

Legal Authority: 42 USC 1395x; 42 USC 1396d; 42 USC 1395bb

CFR Citation: 42 CFR 482

Legal Deadline: Final, Statutory, December 8, 2006, MMA sec 902.

Abstract: This final rule sets forth standards for the use of 
restraints and seclusion in Medicare- and Medicaid-participating 
hospitals as part of the Patients' Rights Condition of Participation 
(CoP) and finalizes other patients' rights afforded by that CoP. It 
finalizes six standards that ensure minimum protections of each 
patient's physical and emotional health and safety. These standards 
address each patient's right to: Notification of his or her rights; the 
exercise of his or her rights in regard to his or her care; privacy and 
safety; confidentiality of patient records; freedom from restraints

[[Page 73259]]

used in the provision of acute medical and surgical care unless 
clinically necessary; and freedom from seclusion and restraint.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              07/02/99                    64 FR 36069
Final Action                    12/00/06

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Patricia Chmielewski, Health Insurance Specialist, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, Clinical Standards and Quality Group, Mailstop S3-
02-01, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-6899
Email: [email protected]

RIN: 0938-AN30
_______________________________________________________________________




1166. PROGRAM FOR ALL-INCLUSIVE CARE FOR THE ELDERLY (PACE): PROGRAM 
REVISIONS (CMS-1201-F)

Priority: Other Significant

Legal Authority: PL 108-173, sec 902 of MMA; BIPA, sec 903

CFR Citation: 42 CFR 460

Legal Deadline: Final, Statutory, December 8, 2006, MMA sec. 902.

Abstract: This rule finalizes two interim final rules with comment 
periods. The November 24, 1999 rule established requirements for 
Programs of All-inclusive Care for the Elderly (PACE) under the 
Medicare and Medicaid programs and the October 1, 2002 rule implemented 
section 903 of BIPA. These are pre-paid, capitated programs for 
beneficiaries who meet special eligibility requirements and who elect 
to enroll.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              11/24/99                    64 FR 66234
Interim Final Rule              10/01/02                    67 FR 61496
Final Action                    12/00/06

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses, Governmental Jurisdictions, 
Organizations

Government Levels Affected: Federal, Local, State, Tribal

Agency Contact: Janet Harris, Health Insurance Specialist, Department 
of Health and Human Services, Centers for Medicare & Medicaid Services, 
Center for Medicare Management, Chronic Care Policy Group, Mailstop C5-
05-27, 7500 Security Boulevard, Baltimore, MD 21244-1850
Phone: 410 786-3137
Email: [email protected]

Related RIN: Previously reported as 0938-AL59
RIN: 0938-AN83
_______________________________________________________________________




1167. SPECIAL MEDICARE GME AFFILLATIONS FOR A TEACHING HOSPITAL AFFECTED 
BY A DISASTER (CMS-1531-F2)

Priority: Other Significant

Legal Authority: sec 1886(h)(d) of the Social Security Act

CFR Citation: 42 CFR 413

Legal Deadline: None

Abstract: This rule amends the current closed program regulations and 
Medicare affiliation agreement regulations to ameliorate the disruption 
in residency training caused by Hurricane Katrina and future emergency 
situations. Amendments to current closed program and Medicare 
affiliation agreement regulations will allow hospitals in areas 
affected by Hurricane Katrina and those hospitals adopting displaced 
residents, greater flexibility in maintaining Medicare funding during 
emergency situations. The amended regulations will go into effect 
during emergency situations as defined by the section 1135 emergency 
waiver invoked by the Secretary. Without changes to current 
regulations, adopting hospitals may be financially incapable of 
accepting displaced residents, home hospitals may have increased 
difficulty reopening residency training programs, and residents may be 
unable to continue with their planned residency training.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              04/12/06                    71 FR 18654
Final Rule                      07/06/06                    71 FR 38264
Second Final Action             08/00/07

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Tzvi Hefter, Director, Division of Acute Care, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, Mail Stop C4-07-07, Centers for Medicare and 
Medicaid Services, 7500 Security Boulevard, Baltimore, MD 21244-1850
Phone: 410 786-6014
Email: [email protected]

RIN: 0938-AO35
_______________________________________________________________________




1168. INPATIENT PSYCHIATRIC FACILITY PROSPECTIVE PAYMENT SYSTEM--UPDATE 
FOR RATE YEAR BEGINNING JULY 1, 2007 (RY 2008) (CMS-1479-N)

Priority: Other Significant. Major status under 5 USC 801 is 
undetermined.

Unfunded Mandates: Undetermined

Legal Authority: PL 106-113, sec 124 BBRA

CFR Citation: 42 CFR 412.400 subpart N

Legal Deadline: Final, Statutory, July 1, 2007.

Abstract: This notice updates the Inpatient Psychiatric Facility 
Prospective Payment System for 2008.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Notice                          05/00/07

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected:  Businesses

Government Levels Affected: Local, State

Federalism:  Undetermined

Agency Contact: Janet Samen, Director, Division of Technical Payment 
Policy, Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, Mailstop C5-05-27, 7500 Security Boulevard, 
Baltimore, MD 21244-1850
Phone: 410 786-4533
Email: [email protected]

RIN: 0938-AO40

[[Page 73260]]

_______________________________________________________________________




1169. GROUP HEALTH PLANS AND HEALTH INSURANCE ISSUES UNDER THE NEWBORNS 
AND MOTHERS HEALTH PROTECTION ACT (CMS-4116-F)

Priority: Economically Significant. Major under 5 USC 801.

Legal Authority: 42 USC 300gg to 300gg-63; 300gg-91 to 300gg-92

CFR Citation: 45 CFR 144; 45 CFR 146; 45 CFR 148

Legal Deadline: None

Abstract: This final rule sets forth the post-childbirth 
hospitalization length of stay requirements for group health plans and 
health insurance issuers that cover such length of stays.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Action                    09/00/07

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: Local, State

Federalism:  This action may have federalism implications as defined in 
EO 13132.

Agency Contact: Adam Shaw, Health Insurance Specialist, Department of 
Health and Human Services, Centers for Medicare & Medicaid Services, 
Center for Beneficiary Choices, Employer & Policy Operations Group, 
Mailstop C5-14-15, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-1091
Email: [email protected]

Karen B. Levin, Health Insurance Specialist, Department of Health and 
Human Services, Centers for Medicare & Medicaid Services, Center for 
Beneficiary Choices, Employer & Policy Operations Group, Mailstop C5-
14-15, 7500 Security Boulevard, Baltimore, MD 21244-1850
Phone: 410 786-5445
Email: [email protected]

Related RIN: Related to 0938-AI17
RIN: 0938-AO43
_______________________________________________________________________




1170. HIGH RISK POOLS (CMS-2260-IFC)

Priority: Other Significant. Major under 5 USC 801.

Unfunded Mandates: Undetermined

Legal Authority: Deficit Reduction Act of 2005; (PL 109-171), sec 6202

CFR Citation: Not Yet Determined

Legal Deadline: Final, Statutory, March 31, 2006.

Abstract: Section 6202 of the Deficit Reduction Act of 2005 extends the 
funding and authorizes (H.R. 4519) and appropriates for FY 2006 $75 
million for grants to help fund existing qualified State high risk 
pools and $15 million for grants to assist States to create and 
initially fund qualified high risk pools. The bill also authorizes 
appropriations of $75 million for each year FY 2007 through 2010. The 
section 6202 provision amendment to section 2745 establishes: (1) Seed 
grants to States for the creation and initial operation of a qualified 
high-risk pool for those States that do not have one, (2) grants to 
States to reimburse them for a percentage of losses incurred based on a 
methodology that allocates funding by 40 percent among all States, 30 
percent to States based on their number of uninsured residents and 30 
percent based on the number of people in State risk pools operating as 
an existing qualified high-risk pool during specified years and (3) 
bonus grants for supplemental consumer benefits. A regulation is needed 
in order to implement this provision of the DRA.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              02/00/07

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Federalism:  Undetermined

Agency Contact: Jean Sheil, Director, Family and Children's Health 
Programs Group, Department of Health and Human Services, Centers for 
Medicare & Medicaid Services, Centers for Medicaid Services Operations, 
Mailstop C2-01-16, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-5647
Email: [email protected]

RIN: 0938-AO46
_______________________________________________________________________




1171. TARGETED CASE MANAGEMENT (CMS-2237-IFC)

Priority: Other Significant. Major under 5 USC 801.

Legal Authority: Deficit Reduction Act of 2005; (PL 109-171), sec 6052

CFR Citation: 42 CFR 431, 440, 441

Legal Deadline: Final, Statutory, January 1, 2006.

Abstract: This regulation is required by the Deficit Reduction Act. It 
clarifies what is reimbursable under the Medicaid case management and 
targeted case management benefit and is intended to offer guidance to 
States on implementing the statutory provision.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              01/00/07

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Theresa A. Pratt, Health Insurance Specialist, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, Mail Stop S2-14-26, 7500 Security Boulevard, 
Baltimore, MD 21244-1850
Phone: 410 786-5831
Email: [email protected]

RIN: 0938-AO50
_______________________________________________________________________




1172. CITIZENSHIP DOCUMENTATION REQUIREMENTS (CMS-2257-F)

Priority: Other Significant

Legal Authority: Deficit Reduction Act of 2005 (PL 109-171), sec 6036; 
sec 1102 of Social Security Act

CFR Citation: 42 CFR 435.403; 42 CFR 435.1009; 42 CFR 435. 1010; 42 CFR 
435.406; 42 CFR 435.407; 42 CFR 435.1002; 42 CFR 435.408; 42 CFR 
435.1008; 42 CFR 435.1011; 42 CFR 436.406; 42 CFR 436.403; 42 CFR 
436.407; 42 CFR 436.408; 42 CFR 436.1004; 42 CFR 436.1005; 42 CFR 
440.2; 42 CFR 435.1009; 42 CFR 435.1010; 42 CFR 440.140; 42 CFR 
440.180; 42 CFR 440.185; 42 CFR 441.13; 42 CFR 457.310; 42 CFR 483.5; 
42 CFR 483.20; 42 CFR 483.102; 42 CFR 483.136; . . .

Legal Deadline: Final, Statutory, July 1, 2006.

[[Page 73261]]

Abstract: Enactment of section 6036 of the Deficit Reduction Act of 
2005 (DRA) requires that, effective July 1, 2006, all new applicants 
for Medicaid must, in addition to declaring that they are a citizen or 
national of the United States or an alien in a satisfactory immigration 
status, if claiming to be a citizen or national submit to the State 
evidence of citizenship. Since 1987, aliens claiming to be in a 
satisfactory immigration status have had to provide evidence of the 
claimed status and have that status verified with the Department of 
Homeland Security (previously the Immigration and Naturalization 
Service). A regulation is needed in order to implement this provision 
of the DRA.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule Comment 
Period                          07/12/06                    71 FR 39214
Interim Final Rule Comment 
Period End                      08/11/06
Final Action                    08/00/07

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Agency Contact: Jean Sheil, Director, Family and Children's Health 
Programs Group, Department of Health and Human Services, Centers for 
Medicare & Medicaid Services, Centers for Medicaid States Operations, 
Mailstop S2-01-16, 7500 Security Boulevard, Baltimore, MD 21244-1850
Phone: 410 786-5957
Fax: 410 786-8534
Email: [email protected]

RIN: 0938-AO51
_______________________________________________________________________




1173. SELF-DIRECTED PERSONAL ASSISTANCE SERVICES STATE PLAN OPTION (CMS-
2229-IFC)

Priority: Other Significant

Legal Authority: Deficit Reduction Act of 2005; (PL 109-171), sec 6087

CFR Citation: Not Yet Determined

Legal Deadline: Final, Statutory, January 1, 2007.

Abstract: The regulation is in support of the Deficit Reduction Act. 
Section 6087 allows a State to offer self-directed personal assistance 
services as a State Plan option and is intended to offer guidance to 
States on implementing the statutory provision.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              12/00/06

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: Federal, State

Agency Contact: Theresa Pratt, Director, Division of Integrated Health 
Systems, Disabled and Elderly Health Programs Group, Department of 
Health and Human Services, Centers for Medicare & Medicaid Services, 
Center for Medicaid State Operations, Mailstop S2-14-26, 7500 Security 
Boulevard, Baltimore, MD 21244
Phone: 410 786-9499
Email: [email protected]

RIN: 0938-AO52
_______________________________________________________________________




1174. [bull] INPATIENT HOSPITAL DEDUCTIBLE AND HOSPITAL AND EXTENDED 
CARE SERVICES COINSURANCE AMOUNTS FOR CY 2008 (CMS-8032-N)

Priority: Other Significant

Legal Authority: 42 USC 1395c-2 (b)(2), Social Security Act, sec 1813 
(b)(2)

CFR Citation: None

Legal Deadline: Final, Statutory, September 15, 2007.

Abstract: This notice announces the inpatient hospital deductible and 
the hospital and extended care services coinsurance amounts for 
services furnished in calendar year 2008 under Medicare's Hospital 
Insurance program (Medicare Part A). The Medicare statute specifies the 
formulae used to determine these amounts.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Notice                          09/00/07

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Clare McFarland, Deputy Director, Medicare and Medicaid 
Cost Estimates Group, Department of Health and Human Services, Centers 
for Medicare & Medicaid Services, Mailstop N3-26-00, Office of the 
Actuary, 7500 Security Boulevard, Baltimore, MD 21244-1850
Phone: 410 786-6390
Email: [email protected]

RIN: 0938-AO61
_______________________________________________________________________




1175. [bull] PART A PREMIUMS FOR CY 2008 FOR THE UNINSURED AGED AND FOR 
CERTAIN DISABLED INDIVIDUALS WHO HAVE EXHAUSTED OTHER ENTITLEMENT (CMS-
8031-N)

Priority: Other Significant

Legal Authority: 42 USC 1395i-2(d)(2); 42 USC 1395i-2a(d)(2); Social 
Security Act, section 1818(d)(2); Social Security Act, section 1818A 
(d)(2)

CFR Citation: None

Legal Deadline: Final, Statutory, September 30, 2007.

Abstract: This notice announces the hospital insurance amount premium 
for calendar year 2008 under Medicare's Hospital Insurance program 
(Medicare Part A) for the uninsured aged and for certain disabled 
individuals who have exhausted other entitlement.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Notice                          09/00/07

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Clare McFarland, Deputy Director, Medicare and Medicaid 
Cost Estimates Group, Department of Health and Human Services, Centers 
for Medicare & Medicaid Services, Mailstop N3-26-00, Office of the 
Actuary, 7500 Security Boulevard, Baltimore, MD 21244-1850
Phone: 410 786-6390
Email: [email protected]

RIN: 0938-AO62
_______________________________________________________________________




1176. [bull] PART B MONTHLY ACTUARIAL RATES AND PREMIUM RATES BEGINNING 
JANUARY 1, 2008 (CMS-8033-N)

Priority: Other Significant

Legal Authority: 42 USC 1395 Social Security Act, section 1839; MMA, 
Section 629; MMA, Section 811; DRA, Section 511

CFR Citation: None

Legal Deadline: Final, Statutory, September 30, 2007.

[[Page 73262]]

Abstract: This notice announces the monthly actuarial rates for aged 
(age 65 and over) and disabled (under age 65) enrollees in Part B of 
Medicare for calendar year 2008. It also announces the monthly Part B 
premiums and the Part B deductible during calendar year 2008.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Notice                          09/00/07

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Suzanne Codespote, Deputy Director, Medicare and 
Medicaid Cost Estimates Group, Department of Health and Human Services, 
Centers for Medicare & Medicaid Services, N3-26-00, 7500 Seurity 
Boulevard, Baltimore, MD 21244
Phone: 410 786-7737
Email: [email protected]

RIN: 0938-AO68
_______________________________________________________________________




1177. [bull] REVISED PAYMENT SYSTEM FOR SERVICES FURNISHED IN AMBULATORY 
SURGICAL CENTERS (ASCS) EFFECTIVE JANUARY 1, 2008 (CMS-1517-F)

Priority: Economically Significant. Major under 5 USC 801.

Unfunded Mandates: Undetermined

Legal Authority: 1833(i)(2)(D)(iii)

CFR Citation: 42 CFR 416

Legal Deadline: Final, Statutory, January 1, 2008.

Abstract: This rule revises the method by which Medicare sets payment 
rates for ASC facility services, and includes new payment rates for ASC 
services in accordance with that methodology. This rule finalizes 
policies proposed as part of CMS-1506-P.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Action                    11/00/07

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: State

Agency Contact: Joan Sanow, Deputy Director, Division of Outpatient 
Services, Department of Health and Human Services, Centers for Medicare 
& Medicaid Services, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-7802
Email: [email protected]

Related RIN: Split from 0938-AO15
RIN: 0938-AO73
_______________________________________________________________________




1178. [bull] FISCAL YEAR 2008 SCHIP ALLOTMENTS (CMS-2262-N)

Priority: Other Significant

Legal Authority: Title XXI of the Social Security Act, sec 2104

CFR Citation: Not Yet Determined

Legal Deadline: Final, Statutory, September 30, 2007.

Abstract: This notice sets forth the final State Children's Health 
Insurance Program (SCHIP) allotments of Federal funding available to 
each State, the District of Columbia, and each U.S. Territory and 
Commonwealth for fiscal year 2007.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Notice                          08/00/07

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: State

Agency Contact: Richard Strauss, Technical Director, Department of 
Health and Human Services, Centers for Medicare & Medicaid Services, 
Centers for Medicaid State Operations, Mailstop S3-13-15, 7500 Security 
Boulevard, Baltimore, MD 21244-1850
Phone: 410 786-2019
Fax: 410-786-0025
Email: [email protected]

RIN: 0938-AO76
_______________________________________________________________________


Department of Health and Human Services (HHS)         Long-Term Actions


Centers for Medicare & Medicaid Services (CMS)



_______________________________________________________________________




1179. END STAGE RENAL DISEASE (ESRD) CONDITIONS FOR COVERAGE (CMS-3818-
F) (SECTION 610 REVIEW)

Priority: Other Significant

Legal Authority: 42 USC 1395rr et al

CFR Citation: 42 CFR 400, 42 CFR 405,; 42 CFR 410, 42 CFR 413, 42 CFR 
414; 42 CFR 488 and CFR 494

Legal Deadline: Final, Statutory, February 4, 2008, MMA sec. 902.

Abstract: This final rule revises the requirements that end stage renal 
disease (ESRD) facilities must meet to be certified under the Medicare 
program.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            02/04/05                     70 FR 6184
Final Action                    02/00/08

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Teresa Casey, Health Insurance Specialist, Department 
of Health and Human Services, Centers for Medicare & Medicaid Services, 
Clinical Standards Group, S3-02-01, 7500 Security Boulevard, Baltimore, 
MD 21244
Phone: 410 786-7215
Email: [email protected]

Rebecca Donnay, Health Insurance Specialist, Department of Health and 
Human Services, Centers for Medicare & Medicaid Services, Clinical 
Standards Group, Mailstop S3-02-01, 7500 Security Boulevard, Baltimore, 
MD 21244
Phone: 410 786-1428
Email: [email protected]

RIN: 0938-AG82

[[Page 73263]]

_______________________________________________________________________




1180. HOSPITAL CONDITIONS OF PARTICIPATION: REQUIREMENTS FOR APPROVAL 
AND REAPPROVAL OF TRANSPLANT CENTERS TO PERFORM ORGAN TRANSPLANTS (CMS-
3835-F)

Priority: Other Significant

Legal Authority: 42 USC 1302; 42 USC 1395hh

CFR Citation: 42 CFR 405; 42 CFR 482; 42 CFR 488

Legal Deadline: Final, Statutory, February 4, 2008, MMA sec. 902.

Abstract: This rule establishes conditions of participation for 
Medicare-covered transplant centers.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            02/04/05                     70 FR 6140
Final Action                    02/00/08

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses, Organizations

Government Levels Affected: None

Agency Contact: Eva Fung, Health Insurance Specialist, Department of 
Health and Human Services, Centers for Medicare & Medicaid Services, 
Clinical Standards Group, Mailstop S3-02-01, 7500 Security Boulevard, 
Baltimore, MD 21244
Phone: 410 786-7539
Email: [email protected]

RIN: 0938-AH17
_______________________________________________________________________




1181. HOSPICE CARE CONDITIONS OF PARTICIPATION (CMS-3844-F) (SECTION 610 
REVIEW)

Priority: Other Significant

Legal Authority: 42 USC 1302; 42 USC 1395hh

CFR Citation: 42 CFR 418

Legal Deadline: Final, Statutory, May 27, 2008, MMA sec. 902.

Abstract: This final rule is a regulatory reform initiative that 
revises existing conditions of participation that hospices must meet to 
participate in the Medicare and Medicaid programs. The requirements 
focus on the actual care delivered to patients and patients' families 
by hospices and the results of that care, reflect an interdisciplinary 
view of patient care, and allow hospices greater flexibility in meeting 
quality standards. These changes are an integral part of our efforts to 
achieve broad-based improvements and measurements of the quality of 
care furnished through Federal programs while at the same time reducing 
procedural burdens on providers.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            05/27/05                    70 FR 30840
Final Action                    05/00/08

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected:  Businesses, Organizations

Government Levels Affected: None

Agency Contact: Mary Rossi-Coajou, Health Insurance Specialist, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, Clinical Standards Group, Mailstop S3-02-01, 7500 
Security Boulevard, Baltimore, MD 21244-1850
Phone: 410 786-6051
Email: [email protected]

Danielle Shearer, Health Insurance Specialist, Department of Health and 
Human Services, Centers for Medicare & Medicaid Services, Clinical 
Standards Group, S3-02-01, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-6617
Email: [email protected]

RIN: 0938-AH27
_______________________________________________________________________




1182. ELECTRONIC CLAIMS ATTACHMENTS STANDARDS (CMS-0050-F)

Priority: Economically Significant. Major under 5 USC 801.

Unfunded Mandates: This action may affect State, local or tribal 
governments.

Legal Authority: 42 USC 1320d-2(a)(2)(B)

CFR Citation: 45 CFR 162

Legal Deadline: Final, Statutory, February 21, 1999.

Abstract: This rule finalizes an electronic standard for health care 
claims attachments. The standard is required by the Health Insurance 
Portability and Accountability Act of 1996. It will be used to transmit 
clinical or administrative data, in addition to the data contained in 
the claims standard, to help establish medical necessity or policy 
compliance for coverage and payment.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/23/05                    70 FR 55989
Final Action                    09/00/08

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: Federal, Local, State, Tribal

Federalism:  This action may have federalism implications as defined in 
EO 13132.

Agency Contact: Stanley Nachimson, Senior Technical Advisor, Department 
of Health and Human Services, Centers for Medicare & Medicaid Services, 
Office of E-Health Standards and Services, Mailstop S2-25-17, 7500 
Security Boulevard, Baltimore, MD 21244-1850
Phone: 410 786-6153
Email: [email protected]

RIN: 0938-AK62
_______________________________________________________________________




1183. HEALTH COVERAGE PORTABILITY: TOLLING CERTAIN TIME PERIODS AND 
INTERACTIONS WITH FAMILY AND MEDICAL LEAVE ACT (CMS-2158-F)

Priority: Other Significant

Legal Authority: 42 USC 300gg; PL 104-191

CFR Citation: 45 CFR 146.113; 45 CFR 146.115; 45 CFR 146.117; 45 CFR 
146.120; 45 CFR 146.145

Legal Deadline: None

Abstract: This final rule will clarify certain portability requirements 
for group health plans and issuers of health insurance coverage offered 
in connection with a group health plan. It also implements changes made 
to the Internal Revenue Code, the Employee Retirement Income Security 
Act, and the Public Health Service Act enacted as part of the Health 
Insurance Portability and Accountability Act of 1996.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/30/04                    69 FR 78800
Final Action                    12/00/07

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses, Organizations

[[Page 73264]]

Government Levels Affected: Federal, Local, State

Federalism:  This action may have federalism implications as defined in 
EO 13132.

Agency Contact: Adam Shaw, Health Insurance Specialist, Department of 
Health and Human Services, Centers for Medicare & Medicaid Services, 
Center for Beneficiary Choices, Employer & Policy Operations Group, 
7500 Security Boulevard, Baltimore, MD 21244-1850
Phone: 410 786-1091
Email: [email protected]

Karen Levin, Health Insurance Specialist, Department of Health and 
Human Services, Centers for Medicare & Medicaid Services, Center for 
Beneficiary Choices, Employer & Policy Operations Group, 7500 Security 
Boulevard, Baltimore, MD 21244-1850
Phone: 410 786-5445
Email: [email protected]

RIN: 0938-AL88
_______________________________________________________________________




1184. REVISIONS TO THE APPEALS PROCESS FOR INITIAL CLAIM DETERMINATIONS 
(CMS-4064-F)

Priority: Economically Significant. Major under 5 USC 801.

Legal Authority: Sec 521 of BIPA

CFR Citation: 42 CFR 401 and 405

Legal Deadline: Final, Statutory, March 8, 2008, MMA sec 902.

Abstract: This final rule revises the Medicare appeals process by 
adding five levels of review. It will remove the distinction between 
the processing of initial determinations and appeals under part A and 
part B required by section 521 of Benefits Improvement and Protection 
Act of 2000 (BIPA).

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              03/08/05                    70 FR 11419
Second Interim Final Rule       06/30/05                    70 FR 37700
Third Interim Final Rule        08/26/05                    70 FR 50214
Final Action                    03/00/08

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: Federal

Agency Contact: Arrah Tabe-Bedward, Health Insurance Specialist, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, Mailstop S1-05-06, 7500 Security Boulevard, 
Baltimore, MD 21244-1850
Phone: 410 786-7129
Email: [email protected]

Katherine L. Hosna, Health Insurance Specialist, Department of Health 
and Human Services, Centers for Medicare & Medicaid Services, Mailstop 
C2-12-16, 7500 Security Boulevard, Baltimore, MD 21244-1850
Phone: 410 786-4993
Email: [email protected]

Related RIN: Related to 0938-AK69
RIN: 0938-AM73
_______________________________________________________________________




1185. HOSPITAL CONDITIONS OF PARTICIPATION: REQUIREMENTS FOR HISTORY AND 
PHYSICAL EXAMINATIONS; AUTHENTICATION OF VERBAL ORDERS; SECURING 
MEDICATIONS; AND POST-ANESTHESIA EVALUATIONS (CMS-3122-F)

Priority: Other Significant

Legal Authority: 42 USC 1395x; 42 USC 1396d; 42 USC 1395bb

CFR Citation: 42 CFR 482

Legal Deadline: Final, Statutory, March 25, 2008, MMA sec. 902.

Abstract: This rule reduces the burden on hospitals and allows 
hospitals to conform to current standards of practice. Hospitals must 
meet these final requirements to participate in Medicare and Medicaid 
programs. They must establish and maintain policies and procedures that 
will ensure their hospital will meet these requirements by using 
standard practices for history and physical examinations, securing 
medications, authenticating verbal orders, and completing post-
anesthesia evaluations.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            03/25/05                    70 FR 15266
Final Action                    03/00/08

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Organizations

Government Levels Affected: None

Additional Information: Decreases burden for hospitals and clinicians.

Agency Contact: Patricia Chmielewski, Health Insurance Specialist, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, Clinical Standards and Quality Group, Mailstop S3-
02-01, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-6899
Email: [email protected]

RIN: 0938-AM88
_______________________________________________________________________




1186. PRIOR DETERMINATION PROCESS FOR CERTAIN ITEMS AND SERVICES (CMS-
6024-F)

Priority: Other Significant

Legal Authority: Sec 938 of the Medicare Modernization Act of 2003

CFR Citation: 42 CFR 410

Legal Deadline: Final, Statutory, June 8, 2005.

Abstract: Section 938 of the Medicare Modernization Act requires that 
physicians and beneficiaries be able to receive a prior determination 
regarding coverage of certain items and physicians' services beginning 
June 8, 2005. Full knowledge regarding financial liability for these 
services will be available to physicians and beneficiaries before 
expenses are incurred, although prior determination of coverage is not 
required for submission of a claim.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            08/30/05                    70 FR 51321
Final Action                    08/00/08

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Debbie Skinner, Health Insurance Specialist, Department 
of Health and Human Services, Centers for Medicare & Medicaid Services, 
Program Integrity Goup, Office of Financial Management, Mailstop C3-02-
16, 7500 Security Boulevard, Baltimore, MD 21244-1850
Phone: 410 786-7480
Email: [email protected]

RIN: 0938-AN10

[[Page 73265]]

_______________________________________________________________________




1187. MEDICARE SECONDARY PAYER AMENDMENTS (CMS-6272-F)

Priority: Substantive, Nonsignificant. Major status under 5 USC 801 is 
undetermined.

Legal Authority: Sec 301 of the Medicare Modernization Act of 2003

CFR Citation: 42 CFR 411; 42 CFR 489

Legal Deadline: Final, Statutory, December 8, 2003.

Abstract: This final rule implements amendments to the Medicare 
Secondary Payer (MSP) provisions under title III of the Medicare 
Prescription Drug, Improvement, and Modernization Act of 2003 (MMA). 
The MMA amendments clarify the MSP provisions regarding the obligations 
of primary plans and primary payers, the nature of the insurance 
arrangements subject to the MSP rules, the circumstances under which 
Medicare may make conditional payments, and the obligations of primary 
payers to reimburse Medicare.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              02/24/06                     71 FR 9466
Final Action                    02/00/09

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Suzanne Ripley, Health Insurance Specialist, Office of 
Financial Management, Department of Health and Human Services, Centers 
for Medicare & Medicaid Services, Mailstop C3-14-16, 7500 Security 
Boulevard, Baltimore, MD 21244-1850
Phone: 410 786-0970
Fax: 410 786-7030
Email: [email protected]

RIN: 0938-AN27
_______________________________________________________________________




1188. TERMINATION OF NON-RANDOM PREPAYMENT MEDICAL REVIEW (CMS-6022-F)

Priority: Other Significant

Legal Authority: Sec 934 of the MMA

CFR Citation: 42 CFR 421

Legal Deadline: Final, Statutory, October 7, 2008, MMA sec. 902.

Abstract: This rule implements the statutory requirements regarding the 
termination of non-random prepayment review under section 934 of the 
Medicare Modernization Act beginning December 8, 2003. This rule 
provides guidelines for terminating a provider of services or supplier 
from non-random payment review.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            10/07/05                    70 FR 58649
Final Action                    10/00/08

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Marie Casey, Health Insurance Specialist, Department of 
Health and Human Services, Centers for Medicare & Medicaid Services, 
Office of Financial Management, Mailstop S3-02-01, 7500 Security 
Boulevard, Baltimore, MD 21244
Phone: 410 786-7861
Email: [email protected]

RIN: 0938-AN31
_______________________________________________________________________




1189. LIMITATION ON RECOUPMENT OF OVERPAYMENTS (CMS-6025-F)

Priority: Other Significant

Legal Authority: Section 1893 (f) (2) of the Social Security Act added 
by Section 935 of the MMA

CFR Citation: 42 CFR 405

Legal Deadline: Final, Statutory, December 8, 2003.

Abstract: This rule implements one provision of section 935 of the 
Medicare Modernization Act which added a new subsection to section 1893 
of the Social Security Act. It adjusts Medicare's ability to recover an 
overpayment when the Qualified Independent Contractor (QIC) receives a 
valid appeal from the provider or supplier. This rule defines the 
overpayments to which the limitation applies, how the limitation works 
in concert with the appeals process, and the change in Medicare's 
obligation to pay interest to a provider or supplier whose appeal is 
successful at levels above the QIC. This rule may cost a provider 
additional interest exposure if the provider appeals an overpayment; 
recoupment is stopped; and the overpayment is affirmed. The provider 
can avoid this by electing to pay the debt through a lump sum or in 
installments.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/22/06                    71 FR 55404
NPRM Comment Period End         11/21/06
Final Action                    09/00/09

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Nancy Braymer, Health Insurance Specialist, Department 
of Health and Human Services, Centers for Medicare & Medicaid Services, 
Mailstop C3-14-21, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-4323
Email: [email protected]

RIN: 0938-AN42
_______________________________________________________________________




1190. MEDICARE PART B COMPETITIVE ACQUISITION OF OUTPATIENT DRUGS AND 
BIOLOGICALS (CMS-1325-F)

Priority: Other Significant

Legal Authority: MMA of 2003, sec 303(d)

CFR Citation: 42 CFR 414

Legal Deadline: Final, Statutory, July 1, 2006.

Abstract: Section 303(d) of the Medicare Modernization Act requires the 
implementation of a competitive bidding program for Medicare Part B 
drugs not paid on a cost or prospective payment system basis. Beginning 
July 1, 2006, physicians will be given a choice between purchasing 
these drugs and being paid by Medicare under the average sales price 
(ASP) system, or obtaining these drugs from vendors selected in a 
competitive bidding process. If the physician elects to obtain drugs 
from a competitive vendor, the vendor will bill Medicare for the drug.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            03/04/05                    70 FR 10745
Interim Final Rule              07/06/05                    70 FR 39022
Second Interim Final Rule       09/06/05                    70 FR 52930
Third Interim Final Rule        11/21/05                    70 FR 70478
Fourth Interim Final Rule       08/18/06                    71 FR 47870

[[Page 73266]]

Fourth Interim Final Rule 
Comment Period End              10/02/06
Final Action                    08/00/09

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Corinne Axelrod, Health Insurance Specialist, Hospital 
& Ambulatory Policy Group, Department of Health and Human Services, 
Centers for Medicare & Medicaid Services, Mailstop C5-14-03, 7500 
Security Boulevard, Baltimore, MD 21244
Phone: 410 786-5620
Email: [email protected]

RIN: 0938-AN58
_______________________________________________________________________




1191. MEDICARE INTEGRITY PROGRAM, FISCAL INTERMEDIARY AND CARRIER 
FUNCTIONS, AND CONFLICT OF INTEREST REQUIREMENTS (CMS-6030-F)

Priority: Other Significant

Legal Authority: Sec 902 of the MMA

CFR Citation: 42 CFR 400 and 421

Legal Deadline: Final, Statutory, June 17, 2008, MMA sec. 902.

Abstract: This rule finalizes certain sections of the Medicare 
regulations concerning fiscal intermediaries and carriers and brings 
them into conformity with the Medicare statute. The rule would 
distinguish between those functions that the statute requires to be 
included in agreements with fiscal intermediaries and those that may be 
included in the agreements. It would also provide that some or all of 
the functions may be included in carrier contracts. Currently all these 
functions are mandatory for carrier contracts.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/17/05                    70 FR 35204
Final Action                    06/00/08

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Gary D. Williams, Health Insurance Specialist, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, Office of Financial Management, Mailstop C3-02-16, 
7500 Security Boulevard, Baltimore, MD 21244-1850
Phone: 410 786-6433
Email: [email protected]

Related RIN: Related to 0938-AI09
RIN: 0938-AN72
_______________________________________________________________________




1192. PAYMENT ERROR RATE MEASUREMENT (PERM) PROGRAM (CMS-6026-F)

Priority: Other Significant

Legal Authority: Improper Payment Information Act of 2002

CFR Citation: 42 CFR 431; 42 CFR 457

Legal Deadline: Final, Statutory, October 1, 2005.

Abstract: This rule sets forth the State requirements to provide 
information for purposes of estimating improper payments in Medicaid 
and SCHIP. The Improper Payments Information Act of 2002 (IPIA) 
requires heads of Federal agencies to annually estimate and report to 
the Congress these estimates of improper payments for the programs they 
oversee and submit a report on actions the Agency is taking to reduce 
erroneous payments.
This rule also responds to the public comments on the October 5, 2005, 
interim final rule and sets forth State requirements for submitting 
claims and policies to the Federal contractor for purposes of 
conducting fee-for-service and managed care reviews. This rule also 
responds to public comments on the State requirements for conducting 
eligibility reviews and estimating payment error rates due to errors in 
eligibility determinations.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            08/27/04                    69 FR 52620
Interim Final Rule              10/05/05                    70 FR 58260
 Second Interim Final Rule      08/28/06                    71 FR 51049
Final Action                    08/00/09

Regulatory Flexibility Analysis Required: No

Government Levels Affected: State

Agency Contact: Janet Reichert, Technical Advisor, Department of Health 
and Human Services, Centers for Medicare & Medicaid Services, Office of 
Financial Management, Mailstop C3-02-16, 7500 Security Boulevard, 
Baltimore, MD 21244
Phone: 410 786-4580
Email: [email protected]

Related RIN: Related to 0938-AM86
RIN: 0938-AN77
_______________________________________________________________________




1193. NOTIFICATION PROCEDURES FOR HOSPITAL DISCHARGES (CMS-4105-F)

Priority: Other Significant

Legal Authority: 42 USC 1396ff

CFR Citation: 42 CFR 405; 42 CFR 412; 42 CFR 422; 42 CFR 489

Legal Deadline: Final, Judicial, November 26, 2006, Based on language 
in settlement agreement.

Abstract: This rule sets forth new requirements for hospital discharge 
notices under both original Medicare and the Medicare Advantage (MA) 
program. Notably, this rule requires hospitals to comply with a 2-step 
notice process when discharging hospital inpatients that is similar to 
the notice requirements applicable to home health agencies (HHAs), 
skilled nursing facilities (SNFs), and comprehensive outpatient 
rehabilitation facilities (CORFs).

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            04/05/06                    71 FR 17052
NPRM Comment Period End         06/05/06
Final Action                    04/00/09

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Eileen Zerhusen, Health Insurance Specialist, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, Medicare Enrollment & Appeals Group, Mailstop S3-23-
03, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-7803
Email: [email protected]

Related RIN: Merged with 0938-AK48, Merged with 0938-AL67
RIN: 0938-AO41

[[Page 73267]]

_______________________________________________________________________




1194. IDENTIFICATION OF BACKWARD COMPATIBLE VERSION OF ADOPTED STANDARD 
FOR E-PRESCRIBING AND THE MEDICARE PRESCRIPTION DRUG PROGRAM (VERSION 
8.1) (CMS-0018-F)

Priority: Other Significant

Legal Authority: 42 USC 1395

CFR Citation: 42 CFR 423

Legal Deadline: None

Abstract: This final rule identifies Version 8.1 of the National 
Council for Prescription Drug Programs (NCPDP) SCRIPT Standard as a 
backward compatible update of the adopted Version 5.0. This rule also 
permits the voluntary use of Version 8.1 of the NCPDP SCRIPT Standard 
for conducting certain e-prescribing transactions for the electronic 
prescription drug program under title I of the Medicare Prescription 
Drug, Improvement, and Modernization Act of 2003 (MMA).

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              06/23/06                    71 FR 36020
Final Action                    06/00/09

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Gladys C. Wheeler, Health Insurance Specialist, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, Office of Electronic Standards and Services, 
Mailstop S2-16-17, 7500 Security Boulevard, Baltimore, MD 21244-1850
Phone: 410 786-0273
Email: [email protected]

Related RIN: Related to 0938-AN49
RIN: 0938-AO42
_______________________________________________________________________




1195. [bull] PROHIBITION OF MID-YEAR BENEFIT ENHANCEMENTS FOR MEDICARE 
ADVANTAGE ORGANIZATIONS OFFERING PLANS IN CALENDAR YEAR 2007 AND 
SUBSEQUENT CALENDAR YEARS (CMS-4121-F)

Priority: Other Significant

Legal Authority: 42 USC 1302, 1395hh

CFR Citation: 42 CFR 422.2; 42 CFR 422.254

Legal Deadline: None

Abstract: This rule implements new policy, beginning with contracts in 
calendar year 2007, to prohibit Medicare Advantage (MA) organizations 
from offering mid-year benefit enhancements (MYBEs). The policy is 
based on our experience during the first year of the new Medicare 
Advantage program and our belief that, in order to fully comply with 
the statute (MMA), we can no longer permit MYBEs as these threaten the 
integrity of the competitive bidding process established by the 
statute.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/01/06                    71 FR 52014
Final Action                    09/00/09

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: Federal

Agency Contact: Christopher McClintick, Health Insurance Specialist, 
Center for Beneficiary Choices, Department of Health and Human 
Services, Centers for Medicare & Medicaid Services, Medicare Advantage 
Group, Division of Plan Policy, 7500 Security Boulevard, Baltimore, MD 
21244
Phone: 410 786-4682
Email: [email protected]

RIN: 0938-AO54
_______________________________________________________________________


Department of Health and Human Services (HHS)         Completed Actions


Centers for Medicare & Medicaid Services (CMS)



_______________________________________________________________________




1196. REQUIREMENTS FOR PROVIDERS AND SUPPLIERS TO ESTABLISH AND MAINTAIN 
MEDICARE ENROLLMENT (CMS-6002-F2)

Priority: Other Significant

CFR Citation: 42 CFR 424

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Rule                      04/21/06                    71 FR 20754
Correcting Amendment            06/30/06                    71 FR 37504

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Michael Collett
Phone: 410 786-6121

RIN: 0938-AH73
_______________________________________________________________________




1197. ORGAN PROCUREMENT ORGANIZATION CONDITIONS FOR COVERAGE AND 
RECERTIFICATION (CMS-3064-F) (COMPLETION OF A SECTION 610 REVIEW)

Priority: Economically Significant. Major under 5 USC 801.

Legal Authority: 42 USC 1302 et al

CFR Citation: 42 CFR 413; 42 CFR 441; 42 CFR 486; 42 CFR 498

Legal Deadline: Final, Statutory, February 4, 2008, MMA sec 902.

Abstract: This rule establishes conditions for coverage for organ 
procurement organizations (OPOs) to be certified by the Secretary to 
receive payment from Medicare and Medicaid for organ procurement costs, 
and to be designated by the Secretary for a specific geographic service 
area. The Organ Procurement Organization Certification Act of 2000 
requires CMS to increase the certification cycle for OPOs from two 
years to four years and to promulgate new performance standards for 
OPOs.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              12/28/01                    66 FR 67109
NPRM                            02/04/05                     70 FR 6086
Final Rule                      05/31/06                    71 FR 30982

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Marcia Newton, Health Insurance Specialist, Office of 
Clinical Standards and Quality, Department of Health and Human 
Services, Centers for Medicare & Medicaid Services, Clinical Standards 
Group , Division of Institutional Quality Standards, Mailstop S3-02-01,

[[Page 73268]]

7500 Security Boulevard, Baltimore, MD 21244-1850
Phone: 410 786-5265
Email: [email protected]

RIN: 0938-AK81
_______________________________________________________________________




1198. FIRE SAFETY REQUIREMENTS FOR CERTAIN HEALTH CARE FACILITIES; 
ALCOHOL-BASED HAND SANITIZER AMENDMENT (CMS-3145-F)

Priority: Other Significant

CFR Citation: 42 CFR 403; 42 CFR 416; 42 CFR 418; 42 CFR 460; 42 CFR 
482 to 42 CFR 483; 42 CFR 485

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Rule                      09/22/06                    71 FR 55341

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Danielle Shearer
Phone: 410 786-6617
Email: [email protected]

RIN: 0938-AN36
_______________________________________________________________________




1199. REVISIONS TO THE OVERSIGHT AND VALIDATION PROGRAM FOR ACCREDITING 
ORGANIZATIONS APPROVED FOR DEEMING AUTHORITY (CMS-2255-P)

Priority: Other Significant. Major under 5 USC 801.

CFR Citation: 42 CFR 488.1 to 488.9

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn                       08/15/06

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Amber L. Wolfe
Phone: 410 786-6773
Email: [email protected]

RIN: 0938-AN62
_______________________________________________________________________




1200. PHYSICIANS' REFERRALS TO HEALTH CARE ENTITIES WITH WHICH THEY HAVE 
FINANCIAL RELATIONSHIPS; E-PRESCRIBING EXCEPTIONS (CMS-1303-F)

Priority: Other Significant

CFR Citation: 42 CFR 411.357

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    08/08/06                    71 FR 45140

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Linda P. Howard
Phone: 410 786-5255
Email: [email protected]

RIN: 0938-AN69
_______________________________________________________________________




1201. HOME HEALTH PAYMENT SYSTEM RATE UPDATE FOR CY 2007 AND DEFICIT 
REDUCTION ACT OF 2005 CHANGES TO MEDICARE PAYMENT FOR OXYGEN EQUIPMENT 
AND CAPPED RENTAL DURABLE MEDICAL EQUIPMENT (CMS-1304-F)

Priority: Economically Significant. Major under 5 USC 801.

CFR Citation: 42 CFR 484

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

NPRM                            08/03/06                    71 FR 44081
Final Action                    11/09/06                    71 FR 65884

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Randy Throndset
Phone: 410 786-0131
Email: [email protected]

RIN: 0938-AN76
_______________________________________________________________________




1202. INPATIENT PSYCHIATRIC FACILITY PROSPECTIVE PAYMENT SYSTEM--UPDATE 
FOR RY 2007 (CMS-1306-F)

Priority: Economically Significant. Major under 5 USC 801.

CFR Citation: 42 CFR 412

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Rule                      05/09/06                    71 FR 27040

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: Local

Agency Contact: Janet Samen
Phone: 410 786-9161
Email: [email protected]

RIN: 0938-AN82
_______________________________________________________________________




1203. INNOVATIONS IN FEE-FOR-SERVICE PAYMENT SYSTEMS TO IMPROVE QUALITY 
AND OUTCOMES (CMS-1298-ANPR)

Priority: Other Significant

CFR Citation: None

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn                       07/02/06

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Gay W. Burton
Phone: 410 786-4564
Email: [email protected]

Teresa Clark
Phone: 410 786-1079
Email: [email protected]

RIN: 0938-AN91
_______________________________________________________________________




1204. HEALTH CARE INFRASTRUCTURE IMPROVEMENT PROGRAM; LOAN PROGRAM FOR 
QUALIFYING HOSPITALS ENGAGED IN CANCER-RELATED HEALTH CARE (CMS-1287-F)

Priority: Economically Significant. Major under 5 USC 801.

CFR Citation: 42 CFR 505

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn                       07/10/06

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Melinda Jones
Phone: 410 786-7069
Email: [email protected]

Tzvi Hefter
Phone: 410 786-4487
Email: [email protected]

Related RIN: Related to 0938-AN93, Merged with 0938-AO12
RIN: 0938-AO03

[[Page 73269]]

_______________________________________________________________________




1205. PROSPECTIVE PAYMENT SYSTEM FOR LONG-TERM CARE HOSPITALS RY 2007: 
ANNUAL PAYMENT RATE UPDATES (CMS-1485-F)

Priority: Economically Significant. Major under 5 USC 801.

CFR Citation: 42 CFR 412

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Rule                      05/12/06                    71 FR 27798

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Linda McKenna
Phone: 410 786-4537
Email: [email protected]

RIN: 0938-AO06
_______________________________________________________________________




1206. QUALITY STANDARDS FOR GENETIC TESTING (CMS-2121-P)

Priority: Other Significant

CFR Citation: None

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn                       08/15/06

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Penelope Mattingly
Phone: 410 786-3366
Email: [email protected]

RIN: 0938-AO09
_______________________________________________________________________




1207. REVISIONS TO THE PAYMENT POLICIES OF AMBULANCE SERVICES UNDER THE 
FEE SCHEDULE FOR AMBULANCE SERVICES (CMS-1317-F)

Priority: Other Significant. Major under 5 USC 801.

CFR Citation: 42 CFR 414.605; 42 CFR 412.64; 42 CFR 410.40; 42 CFR 
410.12; 42 CFR 414.610; 42 CFR 414.615

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

NPRM                            05/26/06                    71 FR 30358
Withdrawn                       09/12/06

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Anne Elizabeth Tayloe
Phone: 410 786-4546
Email: [email protected]

Related RIN: Related to 0938-AO39, Merged with 0938-AO24
RIN: 0938-AO11
_______________________________________________________________________




1208. HOSPITAL INPATIENT PROSPECTIVE PAYMENT SYSTEMS AND FISCAL YEAR 
2007 RATES: FINAL FISCAL YEAR 2007 WAGE INDICES AND PAYMENT RATES AFTER 
APPLICATION OF REVISED OCCUPATIONAL MIX ADJUSTMENT (CMS-1488-N)

Priority: Other Significant

CFR Citation: 42 CFR 412

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

NPRM                            04/25/06                    71 FR 23995
 Second NPRM                    05/17/06                    71 FR 28644
Final Action                    08/18/06                    71 FR 47870
Correction Notice               10/03/06                    71 FR 58286
Notice                          10/11/06                    71 FR 59886

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: Federal

Agency Contact: Tzvi Hefter
Phone: 410 786-4487
Email: [email protected]

Related RIN: Related to 0938-AN93, Related to 0938-AO03, Related to 
0938-AN58
RIN: 0938-AO12
_______________________________________________________________________




1209. CHANGES TO THE HOSPITAL OUTPATIENT PROSPECTIVE PAYMENT SYSTEM AND 
CY 2007 PAYMENT RATES; AND CHANGES TO THE ASC PAYMENT SYSTEM IN CY 2007 
(CMS-1506-F)

Priority: Economically Significant. Major under 5 USC 801.

CFR Citation: 42 CFR 419 to 485

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

NPRM                            08/23/06                    71 FR 49506
Final Action                    11/24/06                    71 FR 67960
Final Action Effective          01/01/07

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: Federal

Federalism:  This action may have federalism implications as defined in 
EO 13132.

Agency Contact: James Hart
Phone: 410 786-9520
Email: [email protected]

Related RIN: Related to 0938-AO13, Related to 0938-AN23
RIN: 0938-AO15
_______________________________________________________________________




1210. PROSPECTIVE PAYMENT SYSTEM FOR INPATIENT REHABILITATION FACILITIES 
FOR FY 2007, CERTAIN PROVISIONS CONCERNING COMPETITIVE ACQUISITION FOR 
DMEPOS (CMS-1540-F)

Priority: Economically Significant. Major under 5 USC 801.

CFR Citation: 42 CFR 412.23, 412.624, 414.1; 414.406, 424.1, 424.57; 
424.58

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

NPRM                            05/15/06                    71 FR 28106
Final Rule                      08/18/06                    71 FR 48354
Correction Notice               09/29/06                    71 FR 57447

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Bill Ullman
Phone: 410 786-5667
Email: [email protected]

RIN: 0938-AO16
_______________________________________________________________________




1211. PART A PREMIUMS FOR CALENDAR YEAR 2007 FOR THE UNINSURED AGED AND 
FOR CERTAIN DISABLED INDIVIDUALS WHO HAVE EXHAUSTED OTHER ENTITLEMENT 
(CMS-8028-N)

Priority: Economically Significant. Major under 5 USC 801.

CFR Citation: None

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Notice                          09/18/06                    71 FR 54661

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Clare McFarland
Phone: 410 786-6390

[[Page 73270]]

Email: [email protected]

RIN: 0938-AO18
_______________________________________________________________________




1212. INPATIENT HOSPITAL DEDUCTIBLE AND HOSPITAL AND EXTENDED CARE 
SERVICES COINSURANCE AMOUNTS FOR CALENDAR YEAR 2007 (CMS-8029-N)

Priority: Economically Significant. Major under 5 USC 801.

CFR Citation: None

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Notice                          09/18/06                    71 FR 54662

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Clare McFarland
Phone: 410 786-6390
Email: [email protected]

RIN: 0938-AO19
_______________________________________________________________________




1213. FISCAL YEAR 2007 SCHIP ALLOTMENTS (CMS-2251-N)

Priority: Other Significant

CFR Citation: 42 CFR 457

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Notice                          07/28/06                    71 FR 42854

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: State

Agency Contact: Richard Strauss
Phone: 410 786-2019
Email: [email protected]

RIN: 0938-AO21
_______________________________________________________________________




1214. FIVE-YEAR REVIEW OF WORK RELATIVE VALUE UNITS UNDER THE PHYSICIAN 
FEE SCHEDULE (CMS-1512-PN)

Priority: Economically Significant. Major under 5 USC 801.

CFR Citation: None

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/29/06                    71 FR 37170
Withdrawn                       09/07/06

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Diane Milstead
Phone: 410 786-3355
Email: [email protected]

Related RIN: Merged with 0938-AO24
RIN: 0938-AO22
_______________________________________________________________________




1215. PART B MONTHLY ACTUARIAL RATES AND PREMIUM RATES BEGINNING JANUARY 
1, 2007 (CMS-8030-N)

Priority: Economically Significant. Major under 5 USC 801.

CFR Citation: None

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Notice                          09/18/06                    71 FR 54665
Correction Notice               09/22/06                    71 FR 55480

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Suzanne Codespote
Phone: 410 786-7737
Email: [email protected]

RIN: 0938-AO23
_______________________________________________________________________




1216. REVISIONS TO PAYMENT POLICIES UNDER THE PHYSICIAN FEE SCHEDULE AND 
AMBULANCE FEE SCHEDULE FOR CALENDAR YEAR 2007 (CMS-1321-FC)

Priority: Economically Significant. Major under 5 USC 801.

CFR Citation: 42 CFR 405; 42 CFR 410 to 411; 42 CFR 413 to 414; 42 CFR 
426

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

NPRM                            08/22/06                    71 FR 48982
Final Action                    12/01/06                    71 FR 69624
Final Action Effective          01/01/07

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses, Organizations

Government Levels Affected: Undetermined

Agency Contact: Diane Milstead
Phone: 410 786-3355
Email: [email protected]

Related RIN: Related to 0938-AN26, Related to 0938-AN05, Related to 
0938-AO22, Related to 0938-AO11
RIN: 0938-AO24
_______________________________________________________________________




1217. PROSPECTIVE PAYMENT SYSTEM AND CONSOLIDATED BILLING FOR SKILLED 
NURSING FACILITIES--UPDATE FOR FY 2007 (CMS-1530-N)

Priority: Economically Significant. Major under 5 USC 801.

CFR Citation: 42 CFR 424

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Notice                          07/31/06                    71 FR 43158
Correction Notice               09/29/06                    71 FR 57519

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses, Organizations

Government Levels Affected: None

Agency Contact: Bill Ullman
Phone: 410 786-5667
Email: [email protected]

RIN: 0938-AO25
_______________________________________________________________________




1218. HOSPICE WAGE INDEX FOR FY 2007 (CMS-1535-N)

Priority: Other Significant

CFR Citation: 42 CFR 418

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    09/01/06                    71 FR 52080
Correction Notice               10/03/06                    71 FR 58415

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Terri Deutsch
Phone: 410 786-9462
Email: [email protected]

RIN: 0938-AO26
_______________________________________________________________________




1219. STATE ALLOTMENTS FOR PAYMENT OF MEDICARE PART B PREMIUMS FOR 
QUALIFYING INDIVIDUALS: FISCAL YEAR 2006 (CMS-2231-F)

Priority: Other Significant

CFR Citation: 42 CFR 433.10

[[Page 73271]]

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              04/28/06                    71 FR 25085
Final Action                    10/16/06                    71 FR 60663

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Governmental Jurisdictions

Government Levels Affected: State

Agency Contact: Richard Strauss
Phone: 410 786-2019
Email: [email protected]

Related RIN: Related to 0938-AO04
RIN: 0938-AO31
_______________________________________________________________________




1220. PROVIDER NOMINATION PROVISION (CMS-1331-P)

Priority: Substantive, Nonsignificant

CFR Citation: 42 CFR 421.103 to 42 CFR 421.106 ; 42 CFR 421.114

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn                       06/07/07

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: Local

Agency Contact: Scott Sturiale
Phone: 410 786-2565
Email: [email protected]

Related RIN: Merged with 0938-AO15
RIN: 0938-AO33
_______________________________________________________________________




1221. EXTENDING SUNSET DATE FOR THE INTERIM FINAL REGULATION ON MENTAL 
HEALTH PARITY (CMS-4094-F4)

Priority: Other Significant

CFR Citation: 45 CFR 146

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Rule                      04/28/06                    71 FR 25092

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: Local, State

Agency Contact: Adam Shaw
Phone: 410 786-1091
Email: [email protected]

Karen Levin
Phone: 410 786-5445
Email: [email protected]

Related RIN: Related to 0938-AN80
RIN: 0938-AO36
_______________________________________________________________________




1222. STATE HEALTH INSURANCE ASSISTANCE PROGRAM (SHIP) (CMS-4005-F)

Priority: Other Significant

CFR Citation: 42 CFR 403

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Rule                      05/26/06                    71 FR 30289

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: Local, State

Agency Contact: Eric Lang
Phone: 410 786-3199
Email: [email protected]

Related RIN: Related to 0938-AJ67
RIN: 0938-AO37
_______________________________________________________________________




1223. STATE CHILDREN'S HEALTH INSURANCE PROGRAM (SCHIP) REDISTRIBUTION 
OF UNEXPENDED SCHIP FUNDS FROM THE APPROPRIATION FOR FISCAL YEAR 2003 
(CMS-2235-NC)

Priority: Other Significant

CFR Citation: 42 CFR 457.600.630

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Notice                          04/21/06                    71 FR 20697

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: State

Agency Contact: Richard Strauss
Phone: 410 786-2019
Email: [email protected]

RIN: 0938-AO38
_______________________________________________________________________




1224. FEE SCHEDULE FOR PAYMENT OF AMBULANCE SERVICES--UPDATE FOR CY 2007 
(CMS-1532-N)

Priority: Economically Significant. Major under 5 USC 801.

CFR Citation: 42 CFR 410

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn                       07/27/06

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Anne Tayloe
Phone: 410 786-4546
Email: [email protected]

Related RIN: Merged with 0938-AO11
RIN: 0938-AO39
_______________________________________________________________________




1225. [bull] FISCAL YEAR DISPROPORTIONATE SHARE HOSPITAL ALLOTMENTS AND 
DISPROPORTIONATE SHARE HOSPITAL INSTITUTIONS FOR MENTAL DISEASE LIMITS 
(CMS-2243-N)

Priority: Other Significant

Legal Authority: Title XIX of the Social Security Act, secs 1923(f) and 
(h); sec 6054 of the Deficit Reduction Act of 2005, PL 109-171

CFR Citation: None

Legal Deadline: Final, Statutory, September 30, 2006, Determination of 
fiscal year DSH allotment and IMD DSH Limits.

Abstract: This notice sets forth the States' final fiscal year (FY) 
2005, preliminary FY 2006, and preliminary FY 2007 disproportionate 
share hospital (DSH) payment allotments and States' institutions for 
mental disease (IMD) DSH limits in the Medicaid program.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Notice                          10/03/06                    71 FR 58398

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: State

Agency Contact: Richard Strauss, Senior Financial Advisor, Department 
of Health and Human Services, Centers for Medicare & Medicaid Services, 
Centers for Medicaid State Operations, Mailstop S3-13-15, 7500 Security 
Boulevard, Baltimore, MD 21244-1850
Phone: 410 786-2019
Fax: 410-786-0025
Email: [email protected]

RIN: 0938-AO75

[[Page 73272]]

_______________________________________________________________________


Department of Health and Human Services (HHS)       Proposed Rule Stage


Administration for Children and Families (ACF)



_______________________________________________________________________




1226. DEVELOPMENTAL DISABILITIES AND BILL OF RIGHTS ACT

Priority: Substantive, Nonsignificant

Legal Authority: PL 106-402; 42 USC 15001 et seq

CFR Citation: 45 CFR 1385 to 1388

Legal Deadline: Final, Statutory, October 30, 2001.

Abstract: A notice of proposed rulemaking to amend current regulations 
and to implement changes made by the Developmental Disabilities 
Assistance and Bill of Rights Act of 2000.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/00/06

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Governmental Jurisdictions, Organizations

Government Levels Affected: Local, State, Tribal

Agency Contact: Elsbeth Wyatt, Program Specialist, Department of Health 
and Human Services, Administration for Children and Families, 370 
L'Enfant Promenade SW., Washington, DC 20447
Phone: 202 690-5841

RIN: 0970-AC07
_______________________________________________________________________




1227. CARE AND PLACEMENT OF UNACCOMPANIED ALIEN CHILDREN

Priority: Other Significant

Legal Authority: 6 USC 279

CFR Citation: 45 CFR 410

Legal Deadline: None

Abstract: This rule concerns the placement of unaccompanied alien 
children in appropriate facilities and homes, the services provided for 
the children while they are in the care of the Office of Refugee 
Resettlement (ORR) and the criteria for release of these children from 
Federal custody to sponsors. The rule also implements ORR's role in 
Flores class-action settlement agreement.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/00/06

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: Federal

Agency Contact: Maureen Dunn, Department of Health and Human Services, 
Administration for Children and Families, 370 L'Enfant Promenade SW., 
Washington, DC 20447
Phone: 202 401-5523
Email: [email protected]

RIN: 0970-AC20
_______________________________________________________________________




1228. MEDICAL SUPPORT

Priority: Other Significant

Legal Authority: 42 USC 1302

CFR Citation: 45 CFR 302 to 305

Legal Deadline: None

Abstract: These rules would require that all support orders in the IV-D 
program address medical support, redefine reasonable-cost health 
insurance, require health insurance to be accessible, and make 
conforming changes to audit and self-assessment requirements.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/00/06

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Governmental Jurisdictions

Government Levels Affected: Local, State

Agency Contact: Elizabeth C. Matheson, Director, Policy and Planning 
Division, Department of Health and Human Services, Administration for 
Children and Families, Office of Child Support Enforcement, 370 
L'Enfant Promenade SW., Washington, DC 20447
Phone: 202 401-9386
Email: [email protected]

RIN: 0970-AC22
_______________________________________________________________________




1229. ADOPTION AND FOSTER CARE ANALYSIS AND REPORTING SYSTEM

Priority: Substantive, Nonsignificant

Legal Authority: 42 USC 679

CFR Citation: 45 CFR 1355

Legal Deadline: None

Abstract: This NPRM amends the Adoption and Foster Care Analysis and 
Reporting System (AFCARS) regulations at 45 CFR 1355.40 and the 
appendices to part 1355 to modify the requirements for States to 
collect and report data to ACF on children in foster care and in 
subsidized adoption or guardianship arrangements with the State. The 
rule also implements the AFCARS penalty requirements of the Adoption 
Promotion Act of 2003 (Pub. L. 108-145).

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/00/06

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: State

Agency Contact: Kathleen McHugh, Director, Division of Policy, 
Children's Bureau, ACYF/ACF/HHS, Department of Health and Human 
Services, Administration for Children and Families, 370 L'Enfant 
Promenade SW., Washington, DC 20447
Phone: 202 401-5789
Fax: 202 205-8221
Email: [email protected]

RIN: 0970-AC23
_______________________________________________________________________




1230. CHILD SUPPORT PROVISIONS OF THE DEFICIT REDUCTION ACT

Priority: Substantive, Nonsignificant

Legal Authority: 42 USC 1302

CFR Citation: Not Yet Determined

Legal Deadline: None

Abstract: The proposed rule would implement provisions of the Deficit 
Reduction Act of 2005 related to review and adjustment of child support 
orders, Federal financial participation in the program, and fees for 
program services.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/00/06

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Governmental Jurisdictions

Government Levels Affected: Federal, Local, State, Tribal

Agency Contact: Elizabeth C. Matheson, Director, Policy and Planning 
Division, Department of Health and Human Services, Administration for 
Children and Families, Office of Child Support Enforcement, 370 
L'Enfant Promenade SW., Washington, DC 20447
Phone: 202 401-9386

[[Page 73273]]

Email: [email protected]

RIN: 0970-AC24
_______________________________________________________________________




1231. PRIVATIZING FUNCTIONS

Priority: Substantive, Nonsignificant

Legal Authority: 42 USC 1302

CFR Citation: 45 CFR 1355 to 1356

Legal Deadline: None

Abstract: Proposed rule would address States' ability to delegate 
decision-making authority to private agencies performing administration 
functions and the availability of funding for training funds under the 
Foster Care program.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            03/00/07

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses, Governmental Jurisdictions

Government Levels Affected: State

Agency Contact: Kathleen McHugh, Director, Division of Policy, 
Children's Bureau, ACYF/ACF/HHS, Department of Health and Human 
Services, Administration for Children and Families, 370 L'Enfant 
Promenade SW., Washington, DC 20447
Phone: 202 401-5789
Fax: 202 205-8221
Email: [email protected]

RIN: 0970-AC25
_______________________________________________________________________




1232. [bull] LIMITATION ON USE OF FUNDS MADE AVAILABLE TO MONITOR AND 
COMBAT TRAFFICKING IN PERSONS

Priority: Other Significant

Legal Authority: 22 USC chapter 78 Trafficking Victims Protection Act

CFR Citation: 45 CFR 404

Legal Deadline: None

Abstract: This rule will implement provisions of the Trafficking 
Victims Protection Act which prohibit programs from using trafficking 
funds to promote, support, or advocate the legalization or practice of 
prostitution and make organizations ineligible to receive such funds 
that promotes, supports, or advocates the legalization or the practice 
of prostitution if the program operates a program that targets several 
forms of trafficking unless the organization provides services to 
individuals solely after they are no longer engaged in activities that 
resulted from such activities being trafficked.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            01/00/07

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Kenneth Tota, Chief of Operations - Office of Refugee 
Resettlement, Department of Health and Human Services, Administration 
for Children and Families, 370 L'Enfant Promenade SW., Washington, DC 
20447
Phone: 202 401-4858
Email: [email protected]

RIN: 0970-AC28
_______________________________________________________________________




1233. [bull] CHILD CARE AND DEVELOPMENT FUND ERROR RATE

Priority: Other Significant

Legal Authority: Improper Payments Information Act (PL 107-300)

CFR Citation: 45 CFR 98

Legal Deadline: None

Abstract: This rule will require States and selected Territories to 
employ a case review process every four years in calculating a CCDF 
error rate.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            01/00/07

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Governmental Jurisdictions

Government Levels Affected: Local, State, Tribal

Agency Contact: Jeffrey J. Polich, Child Care Program Specialist, 
Department of Health and Human Services, Administration for Children 
and Families, 1250 Maryland Avenue SW., 8th Floor, Washington, DC 20447
Phone: 202 205-8696
Email: [email protected]

RIN: 0970-AC29
_______________________________________________________________________




1234. [bull] ABSTINENCE EDUCATION

Priority: Other Significant

Unfunded Mandates: This action may affect State, local or tribal 
governments and the private sector.

Legal Authority: sec 510 of the Social Security Act

CFR Citation: 45 CFR 1352

Legal Deadline: None

Abstract: This rule will provide guidance on the general requirements 
for abstinence education curricula; clarify the treatment of section 
510(b)(2)(A) through (H). Clarify appropriate target age groups for 
title V State Abstinence Education Grants; and, clarify appropriate 
application of additional activities used by title V State Abstinence 
Education grantees.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            01/00/07

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Organizations

Government Levels Affected: State

Federalism:  This action may have federalism implications as defined in 
EO 13132.

Agency Contact: Jeffrey S. Trimbath, Director, Abstinence Education 
Division, Family and Youth Services Bureau, Department of Health and 
Human Services, Administration for Children and Families, 1250 Maryland 
Avenue SW., 8th Floor, Washington, DC 20447
Phone: 202 401-9205
Email: [email protected]

RIN: 0970-AC30

[[Page 73274]]

_______________________________________________________________________


Department of Health and Human Services (HHS)          Final Rule Stage


Administration for Children and Families (ACF)



_______________________________________________________________________




1235. SAFEGUARDING CHILD SUPPORT AND EXPANDED FEDERAL PARENT LOCATOR 
SERVICES (FPLS) INFORMATION

Priority: Other Significant

Legal Authority: 42 USC 652 to 654A; 42 USC 663; 42 USC 1302

CFR Citation: 45 CFR 303.3; 45 CFR 303.21; 45 CFR 303.70

Legal Deadline: None

Abstract: The Personal Responsibility and Work Opportunity 
Reconciliation Act of 1996 made far-reaching amendments to title IV-D 
of the Social Security Act, which governs the child support enforcement 
program. The Balanced Budget Act of 1997, the Adoption and Safe 
Families Act of 1997, and the Child Support Performance and Incentive 
Act of 1998 further amended title IV-D. A significant result of this 
legislation is an expansion in the scope of information available to 
State IV-D child support enforcement agencies. The legislation has 
rendered obsolete or inconsistent several regulations at 45 CFR chapter 
III, Office of Child Support Enforcement, including the regulations on 
the Federal Parent Locator Service, the State Parent Locator Services, 
the offset of Federal payments for purposes of collecting child 
support, and the safeguarding of information. This regulation would 
update various sections in 45 CFR chapter III to reflect the statutory 
changes.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            10/14/05                    70 FR 60038
NPRM Comment Period End         12/13/05
Final Action                    05/00/07

Regulatory Flexibility Analysis Required: No

Government Levels Affected: Local, State, Tribal

Agency Contact: Elizabeth C. Matheson, Director, Policy and Planning 
Division, Department of Health and Human Services, Administration for 
Children and Families, Office of Child Support Enforcement, 370 
L'Enfant Promenade SW., Washington, DC 20447
Phone: 202 401-9386
Email: [email protected]

RIN: 0970-AC01
_______________________________________________________________________




1236. COST ALLOCATION METHODOLOGY APPLICABLE TO THE TEMPORARY ASSISTANCE 
FOR NEEDY FAMILIES PROGRAM

Priority: Other Significant

Legal Authority: 42 USC 1302

CFR Citation: 45 CFR 263; 45 CFR 263.14

Legal Deadline: None

Abstract: This proposed rule will require States (including the 
District of Columbia) and territories to use the ``benefiting'' cost 
allocation methodology in allocating the common administrative costs of 
determining eligibility in the Temporary Assistance for Needy Families 
(TANF) program, the Medicaid program, and the Food Stamp programs.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/27/06                    71 FR 56440
NPRM Comment Period End         11/27/06
Final Action                    09/00/07

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: Local, State

Agency Contact: Grant Collins, Deputy Director, Office of Family 
Assistance, Department of Health and Human Services, Administration for 
Children and Families, 5th Floor East, 370 L'Enfant Promenade SW., 
Washington, DC 20447
Phone: 202 401-6953
Email: [email protected]

RIN: 0970-AC15
_______________________________________________________________________




1237. CHILD CARE AND DEVELOPMENT FUND STATE MATCH PROVISIONS

Priority: Other Significant

Legal Authority: 42 USC 9858C

CFR Citation: 45 CFR 98.16

Legal Deadline: None

Abstract: This proposed rule revises the Child Care and Development 
Fund (CCDF) regulations to permit States to designate multiple public 
and/or private entities as eligible to receive private donations that 
may be certified as child care expenditures for purposes of receiving 
Federal CCDF matching funds.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            11/09/04                    69 FR 64881
Final Action                    05/00/07

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: Local, State

Agency Contact: Shannon Christian, Associate Director, Child Care - 
Office of Family Assistance, Department of Health and Human Services, 
Administration for Children and Families, 1250 Maryland Avenue SW., 8th 
Floor, Washington, DC 20447
Phone: 202 260-2390
Email: [email protected]

RIN: 0970-AC18
_______________________________________________________________________




1238. CHAFEE NATIONAL YOUTH IN TRANSITION DATABASE

Priority: Other Significant

Legal Authority: 42 USC 677

CFR Citation: 45 CFR 1356

Legal Deadline: None

Abstract: This rule would require States to collect and report data on 
youth who are receiving independent living services and the outcomes of 
certain youth who are in foster care or who age-out of foster care.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            07/14/06                    71 FR 40345
Final Action                    07/00/07

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: State

Agency Contact: Kathleen McHugh, Director, Division of Policy, 
Children's Bureau, ACYF/ACF/HHS, Department of Health and Human 
Services, Administration for Children and Families, 370 L'Enfant 
Promenade SW., Washington, DC 20447
Phone: 202 401-5789
Fax: 202 205-8221
Email: [email protected]

RIN: 0970-AC21
_______________________________________________________________________




1239. HEAD START TRANSPORTATION

Priority: Other Significant

Legal Authority: 42 USC 9801 et seq

[[Page 73275]]

CFR Citation: 45 CFR 1310

Legal Deadline: None

Abstract: This proposed rule will address waiver for Head Start 
grantees from certain transportation requirements related to child 
safety restraint systems and bus monitors.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            05/30/06                    71 FR 30645
Final Action                    12/00/06

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Craig Turner, Department of Health and Human Services, 
Administration for Children and Families, P.O. Box 1182, Washington, DC 
20013
Phone: 202 205-8236
Email: [email protected]

RIN: 0970-AC26
_______________________________________________________________________




1240. TANF WORK PROVISIONS OF THE DEFICIT REDUCTION ACT

Priority: Other Significant

Legal Authority: 42 USC 1302

CFR Citation: 261, et al

Legal Deadline: Other, Statutory, June 30, 2006, Interim Final Rule.

Abstract: This rule will address new work requirements associated with 
the Deficit Reduction Act of 2005, including what counts as work 
activities, reporting and verifying hours of work and who should be 
included in the work participation rate.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              06/29/06                    71 FR 37454
Final Action                    04/00/07

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: State, Tribal

Agency Contact: Robert Shelbourne, Director of Policy, OFA/ACF/HHS, 
Department of Health and Human Services, Administration for Children 
and Families, 901 D Street SW., Washington, DC 20447
Phone: 202 401-5150
Email: [email protected]

RIN: 0970-AC27
_______________________________________________________________________


Department of Health and Human Services (HHS)         Completed Actions


Administration for Children and Families (ACF)



_______________________________________________________________________




1241. REASONABLE QUANTITATIVE STANDARD FOR REVIEW AND ADJUSTMENT OF 
CHILD SUPPORT ORDERS

Priority: Other Significant

CFR Citation: 45 CFR 303

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    05/23/06                    71 FR 29590

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: Local, State

Agency Contact: Elizabeth C. Matheson
Phone: 202 401-9386
Email: [email protected]

RIN: 0970-AC19
[FR Doc. 06-8151 Filed 12-08-06; 8:45 am]
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