[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 64554]]



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 this semi-annual publication inventorying 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 our consideration. Members of the public 
wishing to communicate to the Department their views on the potential 
rule-makings outlined below are invited to do so.

FOR FURTHER INFORMATION CONTACT: Ann C. Agnew, Executive Secretary, 
Department of Health and Human Services, Washington, D.C. 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 29, 2005

 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.............................................................
986         Medicare and State Health Care Programs: Fraud and Abuse; Safe Harbor for Certain         0991-AB39
            Electronic Prescribing Arrangements Under the Anti-Kickback Statute...................
----------------------------------------------------------------------------------------------------------------


                                    Office of the Secretary--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
987         Shared Risk Exception to the Safe Harbor Provisions...................................    0991-AA91
988         Safe Harbor for Waiver of Beneficiary Coinsurance and Deductible Amounts for a            0991-AB16
            Medicare SELECT Policy................................................................
989         Clarification of Terms and Application of Program Exclusion Authority for Submitting      0991-AB23
            Claims Containing Excessive Charges...................................................
990         Health Insurance Portability and Accountability Act--Enforcement......................    0991-AB29
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         Claims Collection.....................................................................    0991-AB18
993         Salary Offset.........................................................................    0991-AB19
994         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
----------------------------------------------------------------------------------------------------------------
995         Amending the Regulations Governing Nondiscrimination on the Basis of Race, Color,         0991-AB10
            National Origin, Handicap, Sex, and Age To Conform to the Civil Rights Restoration Act
            of 1987...............................................................................
----------------------------------------------------------------------------------------------------------------


[[Page 64555]]


                 Substance Abuse and Mental Health Services Administration--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
996         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
----------------------------------------------------------------------------------------------------------------
997         Mandatory Guidelines for the Federal Workplace Drug Testing Program...................    0930-AA12
----------------------------------------------------------------------------------------------------------------


                         Centers for Disease Control and Prevention--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
998         Amendments to Quality Assurance and Administrative Provision for Approval of              0920-AA04
            Respiratory Protective Devices........................................................
999         Amendments to Self-Contained Breathing Apparatus Requirements for Approval of             0920-AA10
            Respiratory Protective Devices........................................................
1000        Control of Communicable Diseases, Interstate and Foreign Quarantine (Reg Plan Seq No.     0920-AA12
            42)...................................................................................
----------------------------------------------------------------------------------------------------------------
References in boldface appear in the Regulatory Plan in part II of this issue of the Federal Register.


                          Centers for Disease Control and Prevention--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
1001        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......................................................................
----------------------------------------------------------------------------------------------------------------


                                   Food and Drug Administration--Prerule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
1002        Medical Devices; Current Good Manufacturing Practice (CGMP) Final Rule; Quality           0910-AF71
            Systems Regulations (Section 610 Review)..............................................
----------------------------------------------------------------------------------------------------------------


                                Food and Drug Administration--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
1003        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 (Reg Plan Seq No. 43)....................................................
1004        Chronic Wasting Disease: Control of Food Products and Cosmetics Derived From Exposed      0910-AC21
            Animal Populations....................................................................
1005        Medical Devices; Anesthesiology Devices; Proposed Reclassification of Pressure            0910-AC30
            Regulators for Use With Medical Oxygen................................................
1006        Submission of Standardized Electronic Study Data From Clinical Studies Evaluating         0910-AC52
            Human Drugs and Biologics (Reg Plan Seq No. 44).......................................
1007        Medical Gas Containers and Closures; Current Good Manufacturing Practice Requirements.    0910-AC53
1008        Positron Emission Tomography Drugs; Current Good Manufacturing Practices..............    0910-AC55
1009        Reporting Information Regarding Falsification of Data.................................    0910-AC59
1010        Content and Format of Labeling for Human Prescription Drugs and Biologics;                0910-AF11
            Requirements for Pregnancy and Lactation Labeling (Reg Plan Seq No. 45)...............
1011        Cochineal Extract and Carmine Label Declaration.......................................    0910-AF12

[[Page 64556]]

 
1012        Charging for Investigational Drugs....................................................    0910-AF13
1013        Expanded Access to Investigational Drugs for Treatment Use (Reg Plan Seq No. 46)......    0910-AF14
1014        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.............................................................
1015        Revocation of the Status of Specific Products; Group A Streptococcus..................    0910-AF20
1016        Obstetrical and Gynecological Devices; Designation of Special Control for Condoms and     0910-AF21
            Condoms With Spermicidal Lubricant....................................................
1017        Blood Initiative--Requirements for Human Blood and Blood Components Intended for          0910-AF25
            Transfusion or for Further Manufacturing Use..........................................
1018        Over-the-Counter (OTC) Drug Review--Internal Analgesic Products.......................    0910-AF36
1019        Over-the-Counter (OTC) Drug Review--Labeling of Drug Products for OTC Human Use.......    0910-AF37
1020        Over-the-Counter (OTC) Drug Review--Ophthalmic Products...............................    0910-AF39
1021        Over-the-Counter (OTC) Drug Review--Sunscreen Products................................    0910-AF43
1022        Over-the-Counter (OTC) Drug Review--Weight Control Products...........................    0910-AF45
1023        Substances Prohibited From Use in Animal Food or Feed.................................    0910-AF46
1024        Over-the-Counter (OTC) Drug Review--Dandruff, Seborrheic Dermatitis, and Psoriasis        0910-AF49
            Products..............................................................................
1025        Over-the-Counter (OTC) Drug Review--Skin Bleaching Products...........................    0910-AF53
1026        Over-the-Counter (OTC) Drug Review--Stimulant Drug Products...........................    0910-AF56
1027        Designation of New Animal Drugs for Minor Use and Minor Species.......................    0910-AF60
1028        Blood Vessels Recovered With Organs and Intended for Use in Organ Transplantation.....    0910-AF65
1029        Index of Legally Marketed Unapproved New Animal Drugs for Minor Species...............    0910-AF67
1030        Over-the-Counter (OTC) Drug Review--Poison Treatment Drug Products....................    0910-AF68
1031        Over-the-Counter (OTC) Drug Review--Topical Antimicrobial Drug Products...............    0910-AF69
----------------------------------------------------------------------------------------------------------------
References in boldface appear in the Regulatory Plan in part II of this issue of the Federal Register.


                                 Food and Drug Administration--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
1032        Investigational New Drugs: Export Requirements for Unapproved New Drug Products.......    0910-AA61
1033        Requirements on Content and Format of Labeling for Human Prescription Drugs and           0910-AA94
            Biological Products (Reg Plan Seq No. 47).............................................
1034        Safety Reporting Requirements for Human Drug and Biological Products..................    0910-AA97
1035        Applications for FDA Approval To Market a New Drug; Complete Response Letter;             0910-AB34
            Amendments To Unapproved Applications.................................................
1036        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)..................................................................
1037        Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Dietary         0910-AB88
            Ingredients and Dietary Supplements (Reg Plan Seq No. 48).............................
1038        Additional Safeguards for Children in Clinical Investigations of FDA-Regulated            0910-AC07
            Products..............................................................................
1039        Prevention of Salmonella Enteritidis in Shell Eggs....................................    0910-AC14
1040        Institutional Review Boards: Registration Requirements................................    0910-AC17
1041        Exception From General Requirements for Informed Consent; Request for Comments and        0910-AC25
            Information...........................................................................
1042        Medical Devices; Patient Examination and Surgeons' Gloves; Adulteration...............    0910-AC32
1043        Toll-Free Number for Reporting Adverse Events on Labeling for Human Drugs (Reg Plan       0910-AC35
            Seq No. 49)...........................................................................
1044        Prior Notice of Imported Food Under the Public Health Security and Bioterrorism           0910-AC41
            Preparedness and Response Act of 2002.................................................
1045        Human Subject Protection; Foreign Clinical Studies Not Conducted Under an                 0910-AF15
            Investigational New Drug Application..................................................
1046        Blood Initiative--Revisions to Labeling Requirements for Blood and Blood Components,      0910-AF26
            Including Source Plasma; and Technical Amendment......................................
1047        Infant Formula: Current Good Manufacturing Practices; Quality Control Procedures;         0910-AF27
            Notification Requirements; Records and Reports........................................
1048        Infant Formula Quality Factors........................................................    0910-AF28
1049        Over-the-Counter (OTC) Drug Review--Cough/Cold (Antihistamine) Products...............    0910-AF31
1050        Over-the-Counter (OTC) Drug Review--Cough/Cold (Nasal Decongestant) Products..........    0910-AF34
1051        Over-the-Counter (OTC) Drug Review--Laxative Drug Products............................    0910-AF38

[[Page 64557]]

 
1052        Over-the-Counter (OTC) Drug Review--Skin Protectant Products..........................    0910-AF42
1053        Over-the-Counter (OTC) Drug Review--Vaginal Contraceptive Products....................    0910-AF44
1054        Use of Materials Derived From Cattle in Human Food and Cosmetics......................    0910-AF47
1055        Recordkeeping Requirements for Human Food and Cosmetics Manufactured From, Processed      0910-AF48
            With, or Otherwise Containing Material From Cattle....................................
1056        Over-the-Counter (OTC) Drug Review--Antacid Products..................................    0910-AF52
1057        Supplements and Other Changes to Approved New Animal Drug Applications................    0910-AF59
1058        Biological Products; Bacterial Vaccines and Toxoids; Implementation of Efficacy Review    0910-AF62
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
1059        Requirements for Submission of In Vivo Bioequivalence Data............................    0910-AC23
1060        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.....
1061        Food Standards: General Principles and Food Standards Modernization...................    0910-AC54
1062        Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding     0910-AF08
            of Drugs; Revision of Certain Labeling Controls.......................................
1063        Health Claims.........................................................................    0910-AF09
1064        Food Labeling; Prominence of Calories.................................................    0910-AF22
1065        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....................................................
1066        Over-the-Counter (OTC) Drug Review--Cough/Cold (Bronchodilator) Products..............    0910-AF32
1067        Over-the-Counter (OTC) Drug Review--Cough/Cold (Combination) Products.................    0910-AF33
1068        Over-the-Counter (OTC) Drug Review--External Analgesic Products.......................    0910-AF35
1069        Over-the-Counter (OTC) Drug Review--Oral Health Care Products.........................    0910-AF40
1070        Over-the-Counter (OTC) Drug Review--Overindulgence in Food and Drink Products.........    0910-AF51
1071        Use of Materials Derived From Cattle in Medical Products Intended for Use in Humans       0910-AF54
            and Drugs Intended for Use in Ruminants...............................................
1072        Label Requirement for Food That Has Been Refused Admission Into the United States.....    0910-AF61
1073        Over-the-Counter Antidiarrheal Drug Products..........................................    0910-AF63
1074        Lowfat and Skim Milk and Lowfat and Nonfat Yogurt Products, Lowfat Cottage Cheese:        0910-AF64
            Rev. of Stand. of Ident.; Food Lab., Nutrient Cont. Claims for Fat, Fatty Acids, and
            Cholesterol Cont. of Foods (Section 610 Review).......................................
1075        Over-the-Counter (OTC) Drug Review--Urinary Analgesic Drug Products...................    0910-AF70
----------------------------------------------------------------------------------------------------------------


                                 Food and Drug Administration--Completed Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
1076        Requirements Pertaining to Sampling Services and Private Laboratories Used in             0910-AB96
            Connection With Imported Food.........................................................
1077        Amendments to the Performance Standard for Diagnostic X-Ray Systems and Their Major       0910-AC34
            Components............................................................................
1078        Registration of Food and Animal Feed Facilities.......................................    0910-AC40
1079        Quality Standard Regulation Establishing an Allowable Level for Arsenic in Bottled        0910-AF10
            Water.................................................................................
----------------------------------------------------------------------------------------------------------------


                        Health Resources and Services Administration--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
1080        Designation of Medically Underserved Populations and Health Professional Shortage         0906-AA44
            Areas.................................................................................
1081        National Practitioner Data Bank for Adverse Information on Physicians and Other Health    0906-AA57
            Care Practitioners: Reporting Adverse and Negative Actions............................

[[Page 64558]]

 
1082        Intestines Added to the Definition of Organs Covered by the Rules Governing the           0906-AA62
            Operation of the Organ Procurement and Transplantation Network (OPTN).................
1083        National Vaccine Injury Compensation Program: Calculation of Average Cost of a Health     0906-AA68
            Insurance Policy......................................................................
1084        Healthy Tomorrow's Partnership for Children (HTPC) Program............................    0906-AA70
----------------------------------------------------------------------------------------------------------------


                         Health Resources and Services Administration--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
1085        Interim Final Rule for the Smallpox Emergency Personnel Protection Program: Smallpox      0906-AA60
            (Vaccinia) Vaccine Injury Table.......................................................
1086        Smallpox Vaccine Injury Compensation Program: Administrative Implementation...........    0906-AA61
1087        Requirements Establishing a Limitation on Administrative Expenses; Ryan White CARE Act    0906-AA65
            Title IV Grants for Coordinated Services and Access to Research.......................
1088        Revision to 42 CFR Subpart D--Public Health Service (PHS) Grant Appeals Procedure.....    0906-AA69
----------------------------------------------------------------------------------------------------------------


                         Health Resources and Services Administration--Long-Term Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
1089        National Practitioner Data Bank for Adverse Information on Physicians and Other Health    0906-AA41
            Care Practitioners: Medical Malpractice Payments Reporting Requirements...............
1090        Operation of the Organ Procurement and Transplantation Network (OPTN).................    0906-AA63
----------------------------------------------------------------------------------------------------------------


                                   Indian Health Service--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
1091        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
----------------------------------------------------------------------------------------------------------------
1092        Grants for Research Projects -- 42 CFR Part 52-NPRM...................................    0925-AA42
1093        National Institutes of Health Loan Repayment Programs.................................    0925-AA43
1094        National Library of Medicine Training Grants..........................................    0925-AA44
1095        Minority Biomedical Research Support Program..........................................    0925-AA45
1096        National Institute of Environmental Health Sciences Hazardous Substances Basic            0925-AA46
            Research and Training Grants..........................................................
----------------------------------------------------------------------------------------------------------------


                                 National Institutes of Health--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
1097        National Institutes of Health Training Grants.........................................    0925-AA28
1098        Standards for a National Chimpanzee Sanctuary System..................................    0925-AA31
----------------------------------------------------------------------------------------------------------------


[[Page 64559]]


                                National Institutes of Health--Completed Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
1099        Undergraduate Scholarship Program Regarding Professions Needed by the National            0925-AA10
            Institutes of Health (NIH)............................................................
1100        National Institutes of Health Loan Repayment Program for Research Generally...........    0925-AA18
1101        National Institutes of Health AIDS Research Loan Repayment Program....................    0925-AA32
1102        National Institutes of Health Extramural Loan Repayment Program for Clinical              0925-AA33
            Researchers...........................................................................
1103        National Institutes of Health Pediatric Research Loan Repayment Program...............    0925-AA34
1104        National Institutes of Health Loan Repayment Program for Health Disparities Research..    0925-AA35
1105        National Institutes of Health Clinical Research Loan Repayment Program for Individuals    0925-AA36
            From Disadvantaged Backgrounds........................................................
1106        National Institute of Child Health and Human Development Contraception and Infertility    0925-AA41
            Research Loan Repayment Program.......................................................
----------------------------------------------------------------------------------------------------------------


                               Office of Public Health and Science--Prerule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
1107        Human Subjects Protection Regulations: Additional Protections for Adult Individuals       0940-AA11
            With Impaired Decisionmaking Capacity.................................................
----------------------------------------------------------------------------------------------------------------


                              Office of Public Health and Science--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
1108        Public Health Service Standards for the Protection of Research Misconduct                 0940-AA01
            Whistleblowers........................................................................
1109        Human Subjects Protection Regulations: Institutional Review Boards Registration           0940-AA06
            Requirements..........................................................................
1110        Federal Policy for the Protection of Human Subjects Technical Amendment...............    0940-AA10
----------------------------------------------------------------------------------------------------------------


                             Office of Public Health and Science--Long-Term Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
1111        Human Subjects Protection Regulations: Training and Ed. Requirements for Institutional    0940-AA08
            Officials, Institutional Review Board Members and Staff, Human Protections
            Administrators, and Investigators.....................................................
----------------------------------------------------------------------------------------------------------------


                             Office of Public Health and Science--Completed Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
1112        Public Health Service Policies on Research Misconduct.................................    0940-AA04
----------------------------------------------------------------------------------------------------------------


                             Centers for Medicare & Medicaid Services--Prerule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
1113        Innovations in Fee-for-Service Payment Systems to Improve Quality and Outcomes (CMS-      0938-AN91
            1298-ANPR) (Reg Plan Seq No. 50)......................................................
----------------------------------------------------------------------------------------------------------------
References in boldface appear in the Regulatory Plan in part II of this issue of the Federal Register.


[[Page 64560]]


                          Centers for Medicare & Medicaid Services--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
1114        Home Health Agency (HHA) Conditions of Participation (CoPs) (CMS-3819-P) (Section 610     0938-AG81
            Review)...............................................................................
1115        Standard Unique National Health Plan Identifier (CMS-6017-P)..........................    0938-AH87
1116        Appeals of Carrier Determinations That a Supplier Fails To Meet the Requirements for      0938-AI49
            Medicare Billing Privileges (CMS-6003-P2).............................................
1117        Rural Health Clinics: Amendments to Participation Requirements and Payment Provisions     0938-AJ17
            and Establishment of a Quality Assessment and Improvement Program (CMS-1910-P2).......
1118        Use of Restraints and Seclusion in Medicare and Medicaid Participating Facilities That    0938-AL26
            Provide Inpatient or Residential Care (CMS-2130-P)....................................
1119        Revisions to Conditions for Coverage for Ambulatory Surgical Centers (CMS-3887-P).....    0938-AL80
1120        Modifications to Electronic Transactions and Code Sets (CMS-0009-P)...................    0938-AM50
1121        Requirements for Long-Term Care Facilities: Hospice Services (CMS-3140-P).............    0938-AM87
1122        Competitive Acquisition for Certain Durable Medical Equipment (DME), Prosthetics,         0938-AN14
            Orthotics, and Supplies and Residual Issues (CMS-1270-P) (Reg Plan Seq No. 51)........
1123        Revisions to HIPAA Code Sets (CMS-0013-P).............................................    0938-AN25
1124        Payment for Clinical Laboratory Tests (CMS-1494-P)....................................    0938-AN26
1125        Termination of Non-Random Prepayment Medical Review (CMS-6022-F)......................    0938-AN31
1126         Limitation on Recoupment of Overpayments (CMS-6025-P)................................    0938-AN42
1127        Revisions to the Oversight and Validation Program for Accrediting Organizations           0938-AN62
            Approved for Deeming Authority (CMS-2255-P)...........................................
1128        Physicians' Referrals to Health Care Entities With Which They Have Financial              0938-AN69
            Relationships; Exceptions for Certain Electronic Prescribing and Electronic Health
            Records Arrangements (CMS-1303-F).....................................................
1129        National Plan and Provider Enumeration System (NPPES) Data Dissemination (CMS-6060-PN)    0938-AN71
1130        Changes to the Disclosure of Information Requirements for Quality Improvement             0938-AN73
            Organizations (CMS-3156-P)............................................................
1131        Home Health Payment System Rate Update for Calendar Year 2007 (CMS-1304-P)............    0938-AN76
1132        Fire Safety Requirements for Long-Term Care Facilities: Sprinkler Systems (CMS-3191-P)    0938-AN79
1133        Inpatient Psychiatric Facility Prospective Payment System--Update for 2006 (CMS-1306-     0938-AN82
            P)....................................................................................
1134        Prospective Payment System for Long-Term Care Hospitals FY 2007: Annual Payment Rate      0938-AO06
            Updates (CMS-1485-P)..................................................................
1135        Payments for Service Provided Without Charge (CMS-2489-P).............................    0938-AO07
1136        Revisions to Payment of Ambulance Services under Medicare (CMS-1317-P)................    0938-AO11
1137        Changes to the Hospital Inpatient Prospective Payment Systems and FY 2007 Rates (CMS-     0938-AO12
            1488-P) (Reg Plan Seq No. 52).........................................................
1138        Revised Payment System for Services Furnished in Ambulatory Surgical Centers (ASCs)       0938-AO13
            Effective January 1, 2008 (CMS-1517-P)................................................
1139        Changes to the Hospital Outpatient Prospective Payment System and Calendar Year 2007      0938-AO15
            Payment Rates (CMS-1506-P)............................................................
1140        Prospective Payment System for Inpatient Rehabilitation Facilities for FY 2007 (CMS-      0938-AO16
            1540-P)...............................................................................
1141        Outpatient Hospital Services and Rural Health Clinic Services Amendment (CMS-2213-P)..    0938-AO17
1142        Five Year Review of Work Relative Value Units Under the Physician Fee Schedule (CMS-      0938-AO22
            1512-PN)..............................................................................
1143        Revisions to Payment Policies Under the Physician Fee Schedule for Calendar Year 2007     0938-AO24
            (CMS-1321-P)..........................................................................
1144        Use of Repayment Plans (CMS-6032-P)...................................................    0938-AO27
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
1145        Requirements for Establishing and Maintaining Medicare Billing Privileges (CMS-6002-F)    0938-AH73
1146        Hospital Conditions of Participation: Laboratory Services (CMS-3014-IFC) (Section 610     0938-AJ29
            Review)...............................................................................
1147        Medicare Hospice Care Amendments (CMS-1022-F).........................................    0938-AJ36
1148        Use of Restraint and Seclusion in Residential Treatment Facilities Providing Inpatient    0938-AJ96
            Psychiatric Services to Individuals Under Age 21 (CMS-2065-F).........................
1149        Organ Procurement Organization Conditions for Coverage (CMS-3064-IFR) (Section 610        0938-AK81
            Review) (Reg Plan Seq No. 53).........................................................
1150        Payment for Respiratory Assist Devices With Bi-Level Capability and a Back-Up Rate        0938-AN02
            (CMS-1167-F)..........................................................................
1151        Enhanced DSH Treatment for Certain Hospitals (CMS-2198-F).............................    0938-AN09
1152        Update of the List of Covered Procedures for Ambulatory Surgical Centers for 2005 (CMS-   0938-AN23
            1478-IFC).............................................................................

[[Page 64561]]

 
1153        Medicare Secondary Payer Amendments (CMS-6272-IFC)....................................    0938-AN27
1154        Home Health Prospective Payment System Rate Update for Calendar Year 2006 (CMS-1301-F)    0938-AN44
1155        Changes to the Hospital Outpatient Prospective Payment System and Calendar Year 2006      0938-AN46
            Payment Rates (CMS-1501-FC) (Reg Plan Seq No. 54).....................................
1156        All Provider Bad Debt Payment (CMS-1126-F)............................................    0938-AN75
1157        Payment Error Rate Measurement (PERM) Program (CMS-6026-F)............................    0938-AN77
1158        Revisions to Payment Policies Under the Physician Fee Schedule for Calendar Year 2006     0938-AN84
            (CMS-1502-FC) (Reg Plan Seq No. 55)...................................................
1159        Fee Schedule for Payment of Ambulance Services -- Update for CY 2006 (CMS-1294-N).....    0938-AN99
1160        State Allotments for Payment of Medicare Part B Premiums for Qualifying Individuals       0938-AO04
            (CMS-2210-F)..........................................................................
1161        Federal Government's Adoption of Twenty (20) Healthcare Messaging and Vocabulary          0938-AO05
            Standards Recommended by the Consolidated Health Informatics Initiative (CMS-0015-N)..
1162        Fire Safety Requirements for Religious Non-Medical Health Care Institutions:              0938-AO14
            Correction to Add Written Fire Control Plans & Maintenance of Documentation (CMS-3183-
            IFC)..................................................................................
1163        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).........................
1164        Inpatient Hospital Deductible and Hospital and Extended Care Services Coinsurance         0938-AO19
            Amounts for Calendar Year 2007 (CMS-8029-N)...........................................
1165        Fiscal Year 2007 SCHIP Allotments (CMS-2251-N)........................................    0938-AO21
1166        Part B Monthly Actuarial Rates and Premium Rate Beginning January 1, 2007 (CMS-8030-N)    0938-AO23
1167        Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities--      0938-AO25
            Update for FY 2007 (CMS-1530-N).......................................................
1168        Hospice Wage Index for FY 2007 (CMS-1535-N)...........................................    0938-AO26
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
1169        End Stage Renal Disease (ESRD) Conditions for Coverage (CMS-3818-F) (Section 610          0938-AG82
            Review)...............................................................................
1170        Hospital Conditions of Participation: Requirements for Approval and Re-approval of        0938-AH17
            Transplant Centers To Perform Organ Transplants (CMS-3835-F)..........................
1171        Hospice Care--Conditions of Participation (CMS-3844-F) (Section 610 Review)...........    0938-AH27
1172        Medicare Outcome and Assessment Information Set (OASIS) Data Reporting Requirements       0938-AJ10
            (CMS-3006-F)..........................................................................
1173        Standards for Electronic Health Care Claim Attachments (CMS-0050-P)...................    0938-AK62
1174        Physicians' Referrals to Health Care Entities With Which They Have Financial              0938-AK67
            Relationships (CMS-1810-F)............................................................
1175        Provider Reimbursement Determinations and Appeals (CMS-1727-F)........................    0938-AL54
1176        Health Coverage Portability: Tolling Certain Time Periods and Interactions With Family    0938-AL88
            and Medical Leave Act (CMS-2158-F)....................................................
1177        Electronic Medicare Claims Submission (CMS-0008-F)....................................    0938-AM22
1178        Requirements for Long-Term Care Facilities; Nursing Services; Posting of Nurse            0938-AM55
            Staffing Information (CMS-3121-F).....................................................
1179        Revisions to the Appeals Process for Initial Claim Determinations (CMS-4064-F)........    0938-AM73
1180        Conditions for Coverage of Power Mobility Devices, Including Powered Wheelchairs and      0938-AM74
            Power-Operated Vehicles Scooter (CMS-3017-F)..........................................
1181        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)...................................................
1182        Revised Civil Money Penalties, Assessments, Exclusions, and Related Appeals Procedures    0938-AM98
            (CMS-6146-F)..........................................................................
1183        Prior Determination Process for Certain Items and Services (CMS-6024-P)...............    0938-AN10
1184        Nondiscrimination in Health Coverage and Wellness Plans in the Group Market (CMS-4081-    0938-AN29
            F)....................................................................................
1185        Hospital Conditions of Participation: Patients' Rights (CMS-3018-F)...................    0938-AN30
1186        Federal Enforcement in Group and Individual Health Insurance Markets (CMS-4091-F).....    0938-AN35
1187        Fire Safety Requirements for Certain Health Care Facilities; Alcohol-Based Hand           0938-AN36
            Sanitizer Amendment (CMS-3145-F)......................................................
1188        Revised Civil Money Penalties, Assessments, Exclusions, and Related Appeals Procedures    0938-AN48
            (CMS-6019-F)..........................................................................
1189        Electronic Prescribing Standards (CMS-0011-F).........................................    0938-AN49
1190        Medicare Part B Competitive Acquisition of Outpatient Drugs and Biologicals (CMS-1325-    0938-AN58
            F)....................................................................................

[[Page 64562]]

 
1191        Group Market Health Insurance Reform: Guaranteed Availability, Guaranteed                 0938-AN60
            Renewability, Disclosures to Small Employers (CMS-4102-F).............................
1192        Individual Market Health Insurance Reform: Portability From Group to Individual           0938-AN61
            Coverage; Federal Rules for Access in the Individual Market; State Alternative
            Mechanisms to Federal Rules (CMS-4103-F)..............................................
1193        Medicare Integrity Program, Fiscal Intermediary and Carrier Functions, and Conflict of    0938-AN72
            Interest Requirements (CMS-6030-F)....................................................
1194        Application of Inherent Reasonableness to All Medicare Part B Services (Other than        0938-AN81
            Physician Services) (CMS-1908-F)......................................................
1195        Program for All-Inclusive Care for the Elderly (PACE): Program Revisions (CMS-1201-F).    0938-AN83
1196        Electronic Submission of Cost Reports: Revision to Cost Reporting Period (CMS-1199-F).    0938-AN87
1197        Loan Forgiveness Criteria for the Health Care Infrastructure Loan Program (CMS-1320-F)    0938-AN93
1198        Health Care Infrastructure Improvement Program; Selection Criteria of Loan Program for    0938-AO03
            Qualifying Hospitals Engaged in Cancer-Related Health Care (CMS-1287-F)...............
1199        Medical Improvement Eligibility Group and Definition of Work (CMS-2143-P).............    0938-AO10
----------------------------------------------------------------------------------------------------------------


                           Centers for Medicare & Medicaid Services--Completed Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
1200        Supplier Standards for Home Oxygen, Therapeutic Shoes, and Home Nutrition Therapy (CMS-   0938-AJ98
            6010-P)...............................................................................
1201        Evaluation Criteria and Standards for Quality Improvement Program Contracts (CMS-3142-    0938-AN13
            FN)...................................................................................
1202        Nondiscrimination In Post-Hospital Referral to Home Health Agencies and Other Entities    0938-AN19
            (CMS-1224-F)..........................................................................
1203        Medicare Ambulance Fee Schedule Update (CMS-1492-IFC).................................    0938-AN24
1204        Prospective Payment System for Long Term Care Hospitals: Annual Payment Rate Updates      0938-AN28
            and Policy Changes for 2006 (CMS-1483-F)..............................................
1205        Prospective Payment System for Inpatient Rehabilitation Facilities for FY 2006 (CMS-      0938-AN43
            1290-F)...............................................................................
1206        Development of New Standards for Medigap Policies (CMS-4087-FN).......................    0938-AN50
1207        Fiscal Year 2006 SCHIP Allotments (CMS-2219-N)........................................    0938-AN56
1208        Changes to the Hospital Inpatient Prospective Payment System and FY 2006 Rates (CMS-      0938-AN57
            1500-F)...............................................................................
1209        Special Payment Provisions and Standards for Suppliers of Custom Fabricated Orthotics     0938-AN63
            and Prosthetics (CMS-6012-P)..........................................................
1210        Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities--      0938-AN65
            Update for FY 2006 (CMS-1282-F).......................................................
1211        State Children's Health Insurance Program (SCHIP); Redistribution of Unexpended SCHIP     0938-AN78
            Funds From the Appropriation for Fiscal Year (FY) 2002 (CMS-2230-FN)..................
1212        Extending Sunset Date for the Interim Final Regulation on Mental Health Parity (CMS-      0938-AN80
            4094-F3)..............................................................................
1213        Disproportionate Share Hospital Payments--Institutions for Mental Disease (IMDs) (CMS-    0938-AN88
            2062-N2)..............................................................................
1214        Hospice Wage Index for FY 2006 (CMS-1286-F)...........................................    0938-AN89
1215        Inpatient Rehabilitation Facility Classification Rule Compliance (CMS-1480-N).........    0938-AN92
1216        Withdrawal of Ambulance Fee Schedule Issued in Accordance With Federal District Court     0938-AN94
            Order in Lifestar Ambulance, Inc. v. U.S.--Medicare Covered Ambulance Services (CMS-
            1308-)................................................................................
1217        Immunization Standard for Long Term Care Facilities (CMS-3198-F)......................    0938-AN95
1218        Disproportionate Share Hospital Payments -- Institutions for Mental Disease (IMDs)        0938-AN96
            (CMS-2209-N)..........................................................................
1219        Medicare Prescription Drug Discount Card (CMS-4063-F).................................    0938-AN97
1220        Inpatient Hospital Deductible and Hospital and Extended Care Services Coinsurance         0938-AO00
            Amounts for Calendar Year 2006 (CMS-8026-N)...........................................
1221        Part A Premiums for Calendar Year 2006 for the Uninsured Aged and for Certain Disabled    0938-AO01
            Individuals Who Have Exhausted Other Entitlement (CMS-8025-N).........................
1222        Medicare Part B Monthly Actuarial Rates and Premium Rate Beginning January 1, 2006        0938-AO02
            (CMS-8027-N)..........................................................................
----------------------------------------------------------------------------------------------------------------


                          Administration for Children and Families--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
1223        Safeguarding Child Support and Expanded Federal Parent Locator Services (FPLS)            0970-AC01
            Information...........................................................................

[[Page 64563]]

 
1224        Developmental Disabilities and Bill of Rights Act.....................................    0970-AC07
1225        Administrative Cost Sharing Under TANF................................................    0970-AC15
1226        Care and Placement of Unaccompanied Alien Children....................................    0970-AC20
1227        Chafee National Youth in Transition Database..........................................    0970-AC21
1228        Medical Support.......................................................................    0970-AC22
1229        Adoption and Foster Care Analysis and Reporting System................................    0970-AC23
----------------------------------------------------------------------------------------------------------------


                           Administration for Children and Families--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
1230        Administrative Costs for Children in Title IV-E Foster Care...........................    0970-AC14
1231        Head Start Transportation.............................................................    0970-AC16
1232        Child Care and Development Fund State Match Provisions................................    0970-AC18
1233        Reasonable Quantitative Standard for Review and Adjustment of Child Support Orders....    0970-AC19
----------------------------------------------------------------------------------------------------------------

_______________________________________________________________________


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;'' update 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                            04/00/06
NPRM Comment Period End         06/00/06

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

RIN: 0991-AB03
_______________________________________________________________________




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

Priority: Other Significant

Legal Authority: PL 100-93, sec 14(a); PL 108-173, sec 101(a)(4)(D)(6)

CFR Citation: 42 CFR 1001

Legal Deadline: None

Abstract: This rule will establish a safe harbor with respect to the 
provision of nonmonetary remuneration--in the form of hardware, 
software, or information technology and training services--necessary 
and used solely to receive and transmit electronic prescription 
information in accordance with section 1860-D of the Social Security 
Act.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            10/11/05                    70 FR 59015
NPRM Comment Period End         12/12/05
Final Action                    03/00/06

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-AB39

[[Page 64564]]

_______________________________________________________________________


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


Office of the Secretary (OS)



_______________________________________________________________________




987. 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                    03/00/06

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
_______________________________________________________________________




988. 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                    03/00/06

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

RIN: 0991-AB16
_______________________________________________________________________




989. 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                    04/00/06

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
_______________________________________________________________________




990. HEALTH INSURANCE PORTABILITY AND ACCOUNTABILITY ACT--ENFORCEMENT

Priority: Other Significant

Legal Authority: Subtitle F of title II of PL 104-191; 42 USC 1320d-5

CFR Citation: 45 CFR 160, subparts C to E

Legal Deadline: None

Abstract: This rulemaking would seek to establish a framework for 
enforcing compliance with the ``administrative simplification'' 
provisions of the Health Insurance Portability and Accountability Act 
(HIPAA) of 1996--subtitle F of title II of Public Law 104-191, through 
the imposition of civil money penalties under 42 U.S.C. 1320d-5.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            04/18/05                    70 FR 20224
Final Action                    02/00/06

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Carol Conrad, Department of Health and Human Services, 
Room 5347, Office of the General Counsel, 330 Independence Avenue SW., 
Washington, DC 20201
Phone: 202 690-1840

RIN: 0991-AB29

[[Page 64565]]

_______________________________________________________________________




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                    02/00/06

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
_______________________________________________________________________


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


Office of the Secretary (OS)



_______________________________________________________________________




992. CLAIMS 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 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                     To Be                       Determined

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, Office of the 
General Counsel, Room 5362, HHS Cohen Building, Room 4760, 330 
Independence Avenue SW., Washington, DC 20201
Phone: 202 619-0150

RIN: 0991-AB18
_______________________________________________________________________




993. SALARY OFFSET

Priority: Substantive, Nonsignificant

Unfunded Mandates: Undetermined

Legal Authority: 5 USC 5514; 5 CFR 550

CFR Citation: 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
Final Action                     To Be                       Determined

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, Office of the 
General Counsel, HHS Cohen Building, Room 4760, 330 Independence Avenue 
SW., Washington, DC 20201
Phone: 202 619-0150

RIN: 0991-AB19
_______________________________________________________________________




994. 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

________________________________________________________________________

NPRM                             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

[[Page 64566]]

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)



_______________________________________________________________________




995. AMENDING THE REGULATIONS GOVERNING NONDISCRIMINATION ON THE BASIS 
OF RACE, COLOR, NATIONAL ORIGIN, HANDICAP, SEX, AND AGE TO CONFORM TO 
THE CIVIL RIGHTS RESTORATION ACT OF 1987

Priority: Other Significant

CFR Citation: 45 CFR 80; 45 CFR 84; 45 CFR 86; 45 CFR 90; 45 CFR 91

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Rule                      05/09/05                    70 FR 24314

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses, Governmental Jurisdictions, 
Organizations

Government Levels Affected: Federal, Local, State, Tribal

Agency Contact: Robinsue Frohboese
Phone: 202 619-0403

RIN: 0991-AB10
_______________________________________________________________________


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


Substance Abuse and Mental Health Services Administration (SAMHSA)



_______________________________________________________________________




996. 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                            12/00/05

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)



_______________________________________________________________________




997. 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.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Notice                          04/13/04                    69 FR 19673
Final Action                    12/00/05

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, Room 12C-15, 5600 Fishers Lane, Rockville, MD 
20857
Phone: 301 443-7017
Fax: 301 443-1450
Email: [email protected]

RIN: 0930-AA12

[[Page 64567]]

_______________________________________________________________________


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


Centers for Disease Control and Prevention (CDC)



_______________________________________________________________________




998. 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                            06/00/06

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, NIOSH, P.O. Box 18070, 626 
Cochrans Mill Road, Pittsburgh, PA 15236
Phone: 412 386-4000

RIN: 0920-AA04
_______________________________________________________________________




999. 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                            06/00/06

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, NIOSH, P.O. Box 18070, 626 
Cochrans Mill Road, Pittsburgh, PA 15236
Phone: 412 386-4000

RIN: 0920-AA10
_______________________________________________________________________




1000. CONTROL OF COMMUNICABLE DISEASES, INTERSTATE AND FOREIGN 
QUARANTINE

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

RIN: 0920-AA12
_______________________________________________________________________


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


Centers for Disease Control and Prevention (CDC)



_______________________________________________________________________




1001. [bull] 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 
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, Pub. L. No. 108-375 (codified 
as amended in scattered sections of 42 U.S.C.).

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              12/00/05

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, NIOSH, R44, 4676 Columbia Pkwy, MS 
C-46, Cincinnati, OH 45226
Phone: 513 533-6825

RIN: 0920-AA13

[[Page 64568]]

_______________________________________________________________________


Department of Health and Human Services (HHS)             Prerule Stage


Food and Drug Administration (FDA)



_______________________________________________________________________




1002. [bull] 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 solicit 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 conflicts with other Federal, State, or 
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                      11/00/05

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, Rockville, MD 
20850
Phone: 301 827-2971
Fax: 301 594-4765
Email: [email protected]

RIN: 0910-AF71
_______________________________________________________________________


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


Food and Drug Administration (FDA)



_______________________________________________________________________




1003. FOREIGN AND DOMESTIC ESTABLISHMENT REGISTRATION AND LISTING 
REQUIREMENTS FOR HUMAN DRUGS, INCLUDING DRUGS THAT ARE REGULATED UNDER A 
BIOLOGICS LICENSE APPLICATION, AND ANIMAL DRUGS

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

RIN: 0910-AA49
_______________________________________________________________________




1004. 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, DA is proposing to require that food or cosmetic 
products derived from animals exposed to CWD not enter into commerce.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            05/00/06

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, HFS-306, 
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
_______________________________________________________________________




1005. MEDICAL DEVICES; ANESTHESIOLOGY DEVICES; PROPOSED RECLASSIFICATION 
OF PRESSURE REGULATORS FOR USE WITH MEDICAL OXYGEN

Priority: Substantive, Nonsignificant

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

CFR Citation: 21 CFR 868.2700

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 and to establish a special

[[Page 64569]]

control for oxygen pressure regulators to address problems of fire and 
explosion associated with use of these devices. The special control 
will be a guidance document that includes standardized testing, 
performance, and labeling guidance for industry. Devices that meet the 
special control will be exempt from the premarket notification 
requirements of the Act. The agency believes it is taking a least 
burdensome approach for industry. This proposed rule will phase-in a 
compliance approach that will minimize the cost. FDA seeks to 
reclassify these devices under section 513(e)(1) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 360c(e)(1)).

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/00/05

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, Rockville, MD 
20850
Phone: 301 827-2971
Fax: 301 594-4765
Email: [email protected]

RIN: 0910-AC30
_______________________________________________________________________




1006. SUBMISSION OF STANDARDIZED ELECTRONIC STUDY DATA FROM CLINICAL 
STUDIES EVALUATING HUMAN DRUGS AND BIOLOGICS

 Regulatory Plan: This entry is Seq. No. 44 in part II of this issue of 
the Federal Register.

RIN: 0910-AC52
_______________________________________________________________________




1007. MEDICAL GAS CONTAINERS AND CLOSURES; CURRENT GOOD MANUFACTURING 
PRACTICE REQUIREMENTS

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

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

CFR Citation: 21 CFR 201.161(a); 21 CFR 210.3(b); 21 CFR 211.94

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                            04/00/06

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: None

Agency Contact: Elaine H. Tseng, 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

RIN: 0910-AC53
_______________________________________________________________________




1008. 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                    12/00/06

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: Wayne H. Mitchell, Regulatory Counsel, Office of 
Regulatory Policy, Department of Health and Human Services, Food and 
Drug Administration, Suite 3037 (HFD-7), 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
_______________________________________________________________________




1009. 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 58.11; 21 CFR 71.1; 21 CFR 101.69; 21 CFR 101.70; 
21 CFR 171.1; 21 CFR 190.6; 21 CFR 312.3; 21 CFR 312.56; 21 CFR 511.1; 
21 CFR 812.46

Legal Deadline: None

Abstract: The proposed rule would require sponsors to promptly report 
any information indicating that any person

[[Page 64570]]

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                            06/00/06

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
_______________________________________________________________________




1010. CONTENT AND FORMAT OF LABELING FOR HUMAN PRESCRIPTION DRUGS AND 
BIOLOGICS; REQUIREMENTS FOR PREGNANCY AND LACTATION LABELING

 Regulatory Plan: This entry is Seq. No. 45 in part II of this issue of 
the Federal Register.

RIN: 0910-AF11
_______________________________________________________________________




1011. COCHINEAL EXTRACT AND CARMINE LABEL DECLARATION

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

Legal Authority: 21 USC 379e(b)

CFR Citation: 21 CFR 73.100(d); 21 CFR 73.1100(c); 21 CFR 73.2087(c); 
21 CFR 101.22(k)

Legal Deadline: None

Abstract: The purpose of this proposed rule is to protect consumers who 
have allergies to the color additives carmine and cochineal extract by 
requiring label declaration on products under FDA jurisdiction. This 
action responds to adverse event reports received by FDA and to a 
citizen petition submitted to FDA.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            01/00/06

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
_______________________________________________________________________




1012. 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 treatment use of investigational drugs, 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                            05/00/06

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, Suite 3059 
(HFD-7), Center for Drug Evaulation and Research, 5515 Security Lane, 
Rockville, MD 20852
Phone: 301 594-2041
Fax: 301-827-5562
Email: [email protected]

RIN: 0910-AF13
_______________________________________________________________________




1013. EXPANDED ACCESS TO INVESTIGATIONAL DRUGS FOR TREATMENT USE

 Regulatory Plan: This entry is Seq. No. 46 in part II of this issue of 
the Federal Register.

RIN: 0910-AF14
_______________________________________________________________________




1014. 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 proposing to amend 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), do not allow a 
registered blood establishment that provides health care services to 
concurrently distribute 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 is amending the final rule to allow a 
registered blood establishment that concurrently provides health care 
services related to its activities as a blood establishment to also 
distribute blood derivatives.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/00/05

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

[[Page 64571]]

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 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
_______________________________________________________________________




1015. REVOCATION OF THE STATUS OF SPECIFIC PRODUCTS; GROUP A 
STREPTOCOCCUS

Priority: Info./Admin./Other

Legal Authority: 42 USC 262

CFR Citation: 21 CFR 610.19

Legal Deadline: None

Abstract: FDA is issuing a direct final rule and companion proposed 
rule to revoke 21 CFR 610.19, Status of specific products; Group A 
streptococcus. The products had been licensed by the National 
Institutes of Health prior to 1972, when regulatory authority over 
these products was transferred to FDA. The regulation prohibits the use 
of Group A streptococcus organisms and derivatives of Group A 
streptococcus as ingredients in Bacterial Vaccines and Bacterial 
Antigens with ``No U.S. Standard of Potency.'' The regulation was 
written to apply to a group of products that are no longer on the 
market, namely, streptococcus vaccines and antigens with ``No U.S. 
Standard of Potency'' that were not purified. The regulation was never 
intended to refer to purified streptococcus vaccines, which were not 
developed at that time. Therefore, the regulation is being revoked.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM - Companion to Direct Final 
Rule                            10/00/05
Direct Final Rule               10/00/05

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Valerie Butler, Consumer Safety Officer, Department of 
Health and Human Services, Food and Drug Administration, Suite 200N 
(HFM-17), Center for Biologics Evaluation and Research, 1401 Rockville 
Pike, Suite 200N, Rockville, MD 20852
Phone: 301 827-6210
Fax: 301 827-9434

RIN: 0910-AF20
_______________________________________________________________________




1016. OBSTETRICAL AND GYNECOLOGICAL DEVICES; DESIGNATION OF SPECIAL 
CONTROL FOR CONDOMS AND CONDOMS WITH SPERMICIDAL LUBRICANT

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

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                            12/00/05

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected:  Businesses

Government Levels Affected: None

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, Rockville, MD 
20850
Phone: 301 827-2971
Fax: 301 594-4765
Email: [email protected]

RIN: 0910-AF21
_______________________________________________________________________




1017. 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                            06/00/06

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

[[Page 64572]]

Government Levels Affected: None

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

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




1018. 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 two 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.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM (Amendment) (Required 
Warnings and Other Labeling)    01/00/06
NPRM (Amendment) (Pediatric)    03/00/06
NPRM (Amendment) (Combinations 
with Sodium Bicarbonate)        10/00/06
NPRM (Amendment) 
(Overindulgence/ Hangover)      01/00/06
NPRM (Amendment) (Steven's 
Johnson Warnings)               03/00/06
NPRM (Amendment) (Cardiovascular 
Warnings)                       03/00/06
Final Action (Internal 
Analgesics)                     10/00/06

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: None

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
_______________________________________________________________________




1019. 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 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)        12/00/05

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: None

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
_______________________________________________________________________




1020. 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)            03/00/06

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: None

[[Page 64573]]

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
_______________________________________________________________________




1021. 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 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

________________________________________________________________________

ANPRM (Sunscreen and Insect 
Repellent)                      10/00/06
NPRM (UVA/UVB)                  12/00/05

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: None

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
_______________________________________________________________________




1022. 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 phenylpropanolamine, and the other action 
addresses the ingredient benzocaine.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM (Phenyl propanolamine)     12/00/05
NPRM (Benzocaine)               12/00/05
Final Action (Phenyl 
propanolamine)                  10/00/06

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: None

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
_______________________________________________________________________




1023. 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 349; 21 USC 
371

CFR Citation: 21 CFR 589.2001

Legal Deadline: None

Abstract: The Food and Drug Administration (FDA) is proposing 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                    07/00/06

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
_______________________________________________________________________




1024. 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

[[Page 64574]]

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)                12/00/05

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: None

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
_______________________________________________________________________




1025. 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 drug products containing hydroquinone.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            03/00/06

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: None

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-AF53
_______________________________________________________________________




1026. 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)     01/00/06

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: None

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
_______________________________________________________________________




1027. DESIGNATION OF NEW ANIMAL DRUGS FOR MINOR USE AND MINOR SPECIES

Priority: Other Significant

Legal Authority: 21 USC 360ccc-2

CFR Citation: 21 CFR 514.1(d)(1)(i)

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

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 573 of the MUMS Act which sets forth the 
functional requirements for drug sponsors requesting MUMS designation 
for proposed new animal drugs. MUMS designation of a new animal drug 
will allow 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 will 
define content and format requirements for designation, requests 
changing designation ownership, and annual reporting requirements. This 
rule will also describe the criteria CVM will use for granting or 
denying these requests. Specific sections of the rule will be dedicated 
to documentation of MUMS status in a request, granting MUMS 
designation, and revocation of MUMS designation. This is a voluntary 
program for animal drug sponsors. While we do not have estimates of the 
impact on the animal drug industry, we expect that this rule will have 
a net beneficial impact on the industry with those firms participating 
who hope to profit as a result of the market exclusivity provided by 
the MUMS Act. A large number of these drug companies are classified as 
small businesses.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/27/05                    70 FR 56394

[[Page 64575]]

NPRM Comment Period End         12/12/05
Final Rule                      02/00/06

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
_______________________________________________________________________




1028. [bull] 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) 
are issuing 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 are taking 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 vascular tissue 
(FDA jurisdiction) and organs (HRSA jurisdiction).

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM - Companion to Direct Final 
Rule                            12/00/05
Direct Final Rule               12/00/05

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

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

RIN: 0910-AF65
_______________________________________________________________________




1029. [bull] 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 safety and effectiveness 
of a new animal drug proposed for indexing.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            02/00/06
NPRM Comment Period End         05/00/06

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
_______________________________________________________________________




1030. [bull] 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)                   06/00/06

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: None

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

[[Page 64576]]

Administration, CRP2 RMS214, HFD-560, Rockville, MD 20850
Phone: 301 827-2279
Fax: 301-827-2316
Email: [email protected]

RIN: 0910-AF68
_______________________________________________________________________




1031. [bull] 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)        03/00/06
NPRM (Food Handlers)            03/00/06
NPRM (Healthcare Antiseptics)   03/00/06

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Walter Ellenberg, Regulatory Health Project Manager, 
Center for Drug Evaluation and Research, Department of Health and Human 
Services, Food and Drug Administration, CRP2 RMS214, HFD-560, 
Rockville, MD 20850
Phone: 301 827-2279
Fax: 301-827-2316
Email: [email protected]

RIN: 0910-AF69
_______________________________________________________________________


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


Food and Drug Administration (FDA)



_______________________________________________________________________




1032. INVESTIGATIONAL NEW DRUGS: EXPORT REQUIREMENTS FOR UNAPPROVED NEW 
DRUG PRODUCTS

Priority: Routine and Frequent

Legal Authority: 21 USC 321; 21 USC 381; 21 USC 382; 21 USC 393; 42 USC 
241; 42 USC 243; 42 USC 262; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 
21 USC 371

CFR Citation: 21 CFR 312.110

Legal Deadline: None

Abstract: The final rule would amend the regulations on the exportation 
of unapproved new drug products, including biological products, for 
investigational use. In general, the rule would provide four different 
routes for exporting an unapproved new drug product for investigational 
use. One route would permit exportation, if the drug is the subject of 
an investigational new drug application (IND) and is being exported for 
use in the investigation. A second route would permit exportation, 
without prior Food and Drug Administration (FDA) approval and without 
an IND, if the product is to be exported for use in a clinical 
investigation and has received marketing authorization in certain 
developed countries. The third route would permit exportation, without 
prior FDA approval and without an IND, if the product is to be exported 
for use in a clinical investigation in certain specified developed 
countries. The fourth route would permit exportation without an IND, to 
any country provided that the exporter sends a written certification to 
FDA at the time the drug is first exported. Drugs exported under any of 
the first three routes would, however, be subject to certain statutory 
requirements, such as not conflicting with the foreign country's laws 
and not being sold or offered for sale in the United States. Drugs 
exported under either the second or third routes would be subject to 
additional statutory requirements, such as being in substantial 
conformity with the current good manufacturing practices and certain 
labeling requirements. These provisions would implement changes in 
FDA's export authority resulting from the FDA Export Reform and 
Enhancement Act of 1996 and streamline another mechanism for exporting 
investigational new drugs while providing safeguards.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/19/02                    67 FR 41642
Final Action                    02/00/06

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, Room 15-61 
(HF-23), Office of Policy and Planning, 5600 Fishers Lane, Room 14C-17, 
Rockville, MD 20857
Phone: 301 827-0587
Fax: 301 827-4774
Email: [email protected]

RIN: 0910-AA61
_______________________________________________________________________




1033. REQUIREMENTS ON CONTENT AND FORMAT OF LABELING FOR HUMAN 
PRESCRIPTION DRUGS AND BIOLOGICAL PRODUCTS

 Regulatory Plan: This entry is Seq. No. 47 in part II of this issue of 
the Federal Register.

RIN: 0910-AA94
_______________________________________________________________________




1034. 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

[[Page 64577]]

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              06/00/06

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
_______________________________________________________________________




1035. 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 proposed 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 proposed rule would also 
amend the regulations on extension of the review clock because of 
amendments to applications.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            07/20/04                    69 FR 43357
Final Action                    04/00/06

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
_______________________________________________________________________




1036. 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 263a; 42 USC 264; 21 USC 
372; 21 USC 381; 42 USC 263

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                    12/00/05

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: None

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

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




1037. CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKING, OR 
HOLDING DIETARY INGREDIENTS AND DIETARY SUPPLEMENTS

 Regulatory Plan: This entry is Seq. No. 48 in part II of this issue of 
the Federal Register.

RIN: 0910-AB88

[[Page 64578]]

_______________________________________________________________________




1038. ADDITIONAL SAFEGUARDS FOR CHILDREN IN CLINICAL INVESTIGATIONS OF 
FDA-REGULATED PRODUCTS

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                    06/00/06

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
_______________________________________________________________________




1039. 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 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                    07/00/06

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: Undetermined

Agency Contact: Louis J. Carson, Deputy Director, Food Safety 
Initiative, Department of Health and Human Services, Food and Drug 
Administration, Center for Food Safety and Applied Nutrition (HFS-032), 
5100 Paint Branch Parkway, College Park, MD 20740
Phone: 301 436-2130
Fax: 301 436-2632
Email: [email protected]

RIN: 0910-AC14
_______________________________________________________________________




1040. INSTITUTIONAL REVIEW BOARDS: REGISTRATION REQUIREMENTS

Priority: Info./Admin./Other

Legal Authority: 21 USC 321; 21 USC 346; 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

[[Page 64579]]

CFR Citation: 21 CFR 56.106

Legal Deadline: None

Abstract: The final rule would require institutional review boards 
(IRB) to register with FDA. 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 range of active protocols 
(small, medium, or large) 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                    03/00/06

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, Room 15-61 
(HF-23), 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
_______________________________________________________________________




1041. 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 interim 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              06/00/06

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Catherine Lorraine, Director, Policy Development and 
Coordination Group, Office of Policy and Planning, Department of Health 
and Human Services, Food and Drug Administration, 14-101-11, 5600 
Fishers Lane, Rockville, MD 20857
Phone: 301 827-3360
Fax: 301 594-6777

RIN: 0910-AC25
_______________________________________________________________________




1042. MEDICAL DEVICES; PATIENT EXAMINATION AND SURGEONS' GLOVES; 
ADULTERATION

Priority: Substantive, Nonsignificant

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 would 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                    12/00/05

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, Rockville, MD 
20850
Phone: 301 827-2971
Fax: 301 594-4765
Email: [email protected]

RIN: 0910-AC32
_______________________________________________________________________




1043. TOLL-FREE NUMBER FOR REPORTING ADVERSE EVENTS ON LABELING FOR 
HUMAN DRUGS

 Regulatory Plan: This entry is Seq. No. 49 in part II of this issue of 
the Federal Register.

RIN: 0910-AC35
_______________________________________________________________________




1044. PRIOR NOTICE OF IMPORTED FOOD UNDER THE PUBLIC HEALTH SECURITY AND 
BIOTERRORISM PREPAREDNESS AND RESPONSE ACT OF 2002

Priority: Other Significant. Major under 5 USC 801.

Legal Authority: PL 107-188, sec 307

CFR Citation: 21 CFR 1.276 et seq

Legal Deadline: Final, Statutory, December 12, 2003.
The Public Health Security and Bioterrorism Preparedness and Response 
Act of 2002, section 307, directs the Secretary, through FDA, to issue 
final regulations establishing prior notice requirements for all 
imported food by December 12, 2003. If FDA fails to issue final 
regulations by this date, the statute is self-executing on this date, 
and requires FDA to receive prior notice of not less than eight hours, 
nor more than five days until final regulations are issued.

Abstract: This rulemaking is one of a number of actions being taken to 
improve FDA's ability to respond to threats of bioterrorism. Section 
801(m) of the Federal Food, Drug, and Cosmetic Act (FFDCA), which was 
added by section 307 of the Public Health Security and Bioterrorism 
Preparedness and Response Act of 2002 (the Bioterrorism Act), requires 
notification to FDA prior to the entry of imported food. The required 
prior notice would provide the identity of

[[Page 64580]]

the article of food; the manufacturer; the shipper; the grower, if 
known at the time of notification; the originating country; the 
shipping country; and the anticipated port of entry. The regulation 
identifies the parties responsible for providing the notice and 
explains the information that the prior notice is required to contain, 
the method of submission of the notice, and the minimum and maximum 
period of advance notice required. Section 307 also states that if FDA 
does not receive prior notice or receives inadequate prior notice, the 
imported food shall be refused admission and held at the port of entry 
until proper notice is provided.
Section 307 authorizes the Secretary, through FDA, to promulgate final 
regulations by December 12, 2003. FDA and CBP issued an interim final 
rule (IFR) on October 10, 2003 (68 FR 58974). The IFR originally 
provided a 75-day comment period to ensure that those that comment on 
the IFR have the benefit of our outreach and educational efforts and 
have the experience with the systems, timeframes, and data elements. We 
reopened the comment period for an additional 90 days in April through 
July 2004 to allow for additional comment on the industry's experience 
with the prior notice system, and comment on the Joint FDA-CBP Plan for 
Increasing Integration and Assessing the Coordination of Prior Notice 
Timeframes. The final rule currently is under development, and it will 
confirm or amend the IFR, as appropriate. This final rule is not 
expected to have a significant impact on a substantial number of small 
entities.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            02/03/03                     68 FR 5428
Interim Final Rule              10/10/03                    68 FR 58974
Interim Final Rule Comment 
Period Reopened                 04/14/04                    69 FR 19763
Interim Final Rule Comment 
Period Reopened End             07/13/04
Final Rule                      07/00/06

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: Federal

Agency Contact: May Nelson, Regulatory Counsel, Department of Health 
and Human Services, Food and Drug Administration, HFS-32, Center for 
Food Safety and Applied Nutrition, 5100 Paint Branch Parkway, College 
Park, MD 20740
Phone: 301 436-1722
Fax: 301 436-2637
Email: [email protected]

RIN: 0910-AC41
_______________________________________________________________________




1045. 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                    04/00/06

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, Suite 3037 
(HFD-7), 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
_______________________________________________________________________




1046. BLOOD INITIATIVE--REVISIONS TO LABELING REQUIREMENTS FOR BLOOD AND 
BLOOD COMPONENTS, INCLUDING SOURCE PLASMA; AND TECHNICAL AMENDMENT

Priority: Other Significant

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

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 blood, 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                    06/00/06

Regulatory Flexibility Analysis Required: No

[[Page 64581]]

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
_______________________________________________________________________




1047. 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
Other/NPRM Comment Period 
Reopened                        04/28/03                    68 FR 22341
Other/NPRM Comment Period 
Extended                        06/27/03                    68 FR 38247
NPRM Comment Period End         08/26/03
Final Action                    09/00/06

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Melissa Scales, Regulatory Counsel, Department of 
Health and Human Services, Food and Drug Administration, HFS-024, 
Center for Food Safety and Applied Nutrition, 5100 Paint Branch 
Parkway, College Park, MD 20740
Phone: 301 436-1720
Email: [email protected]

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




1048. 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.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

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

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Melissa Scales, Regulatory Counsel, Department of 
Health and Human Services, Food and Drug Administration, HFS-024, 
Center for Food Safety and Applied Nutrition, 5100 Paint Branch 
Parkway, College Park, MD 20740
Phone: 301 436-1720
Email: [email protected]

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




1049. 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)                           12/00/05

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: None

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

[[Page 64582]]

_______________________________________________________________________




1050. 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 phenylpropanolamine.

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 (Phenyl propanolamine)     12/00/05
Final Action (Amendment) 
(Sinusitis Claim)               10/31/05                    70 FR 58974
Final Action (Phenyl 
propanolamine)                  10/00/06
Final Action (Phenylephrine 
Bitartrate)                     12/00/05

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: None

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
_______________________________________________________________________




1051. 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. This action 
will address laxative drug products.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Action (Laxative Drug 
Products)                       03/00/06
Final Action (Granular Psyllium)10/00/06

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: None

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
_______________________________________________________________________




1052. 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)                     12/00/05
Final Action (Fever Blisters/
Cold Sores)                     10/00/06
Final Action (Diaper Rash)      03/00/06
NPRM (Amendment) (Diaper Rash 
Drug Product)                   10/00/06

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: None

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
_______________________________________________________________________




1053. 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

[[Page 64583]]

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 warning statements for products containing nonoxynol 
9.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Action (Warnings)         12/00/05
NPRM (Vaginal Contraceptive Drug 
Products)                       10/00/06

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: None

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
_______________________________________________________________________




1054. 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, effective 
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 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.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              07/14/04                    69 FR 42256
Interim Final Rule Comment 
Period End                      10/12/04
Final Action                    07/00/06
Interim Final Rule (Ammendments)09/07/05                    70 FR 53063
Interim Final Rule (Ammendments) 
Comment Period End              11/07/05

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

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-AF47
_______________________________________________________________________




1055. RECORDKEEPING REQUIREMENTS FOR HUMAN FOOD AND COSMETICS 
MANUFACTURED FROM, PROCESSED WITH, OR OTHERWISE CONTAINING MATERIAL FROM 
CATTLE

Priority: Other Significant

Legal Authority: 21 USC 342; 21 USC 361; 21 USC 371; 21 USC 381

CFR Citation: 21 CFR 189.5; 21 CFR 700.27

Legal Deadline: None

Abstract: On July 14, 2004, FDA proposed to require that manufacturers 
and processors of human food and cosmetics that are manufactured from, 
processed with, or otherwise contain, material from cattle must 
establish and maintain records sufficient to demonstrate the food or 
cosmetic is not manufactured from, processed with, or does not 
otherwise contain, prohibited cattle materials. This is a companion 
rulemaking to FDA's interim final rule entitled ``Use of Materials 
Derived From Cattle in Human Food and Cosmetics.`` FDA intends to 
finalize this proposal after reviewing any comments received.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            07/14/04                    69 FR 42275
NPRM Comment Period End         08/13/04
Final Action                    12/00/05

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: None

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-AF48
_______________________________________________________________________




1056. 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

[[Page 64584]]

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 (Sodium Bicarbonate 
Labeling)                       01/00/06
Final Action (Overindulgence 
Labeling)                       01/00/06

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: None

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-AF52
_______________________________________________________________________




1057. SUPPLEMENTS AND OTHER CHANGES TO APPROVED NEW ANIMAL DRUG 
APPLICATIONS

Priority: Substantive, Nonsignificant

Legal Authority: 21 USC 356a

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                    01/00/06
Final Action Effective          03/00/06

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
_______________________________________________________________________




1058. BIOLOGICAL PRODUCTS; BACTERIAL VACCINES AND TOXOIDS; 
IMPLEMENTATION OF EFFICACY REVIEW

Priority: Substantive, Nonsignificant

Legal Authority: 21 USC 321; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 
21 USC 358; 21 USC 360; 21 USC 360b to 360d; 21 USC 360h; 21 USC 360i; 
21 USC 360gg to 360ss; 21 USC 371; 21 USC 372; 21 USC 374; 21 USC 379e; 
21 USC 381; 42 USC 216; 42 USC 241; 42 USC 262; 42 USC 263; 42 USC 
263a; 42 USC 264

CFR Citation: 21 CFR 201.59; 21 CFR 610.21

Legal Deadline: None

Abstract: On December 13, 1985, the Food and Drug Administration (FDA) 
proposed to amend the biologics regulations and proposed to classify 
the bacterial vaccines and toxoids on the basis of findings and 
recommendations of the Panel on Review of Bacterial Vaccines and 
Toxoids (the Panel). The Panel reviewed the safety, efficacy, and 
labeling of bacterial vaccines and toxoids with standards of potency, 
bacterial antitoxins, and immune globulins. After reviewing the Panel's 
report and comments on the proposal, FDA published a final rule and 
final order on January 5, 2004 (69 FR 255). On October 27, 2004, the 
United States District Court for the District of Columbia vacated the 
January 5, 2004, final rule and final order. On December 29, 2004 (69 
FR 78280), FDA published a withdrawal of the January 5, 2004, final 
rule and final order. Concurrently with the withdrawal of the final 
rule and final order, FDA published again a proposed rule and proposed 
order (December 2004 proposal) (69 FR 78281) to provide notice and to 
give interested persons an opportunity to comment. FDA is proposing to 
amend the biologics regulations in response to the report and 
recommendations of the Panel and in consideration of comments submitted 
to the Division of Dockets Management. FDA intends to classify these 
products as Category I (safe, effective, and not misbranded), Category 
II (unsafe, ineffective, or misbranded), or Category IIIB (off the 
market pending completion of studies permitting a determination of 
effectiveness).
The December 2004 proposal included a proposed order for Anthrax 
Vaccine Absorbed. The final order Anthrax Vaccine Absorbed will be 
published separately in the same issue of the Federal Register as the 
final rule and final order for the other products included in the 
December 2004 proposal.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/29/04                    69 FR 78281
NPRM Comment Period End         03/29/05
Final Action                    12/00/05

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Astrid L. Szeto, Senior Regulatory Review Officer,

[[Page 64585]]

Department of Health and Human Services, Food and Drug 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-AF62
_______________________________________________________________________


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


Food and Drug Administration (FDA)



_______________________________________________________________________




1059. 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, HFD-7, 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
_______________________________________________________________________




1060. 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
_______________________________________________________________________




1061. 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

[[Page 64586]]

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 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, HFS-820, 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
_______________________________________________________________________




1062. 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
_______________________________________________________________________




1063. 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: Nancy Crane, Department of Health and Human Services, 
Food and Drug Administration, HFS-830, 5100 Paint Branch Parkway, 
College Park, MD 20740
Phone: 301 436-1456
Fax: 301 436-2636
Email: [email protected]

RIN: 0910-AF09

[[Page 64587]]

_______________________________________________________________________




1064. 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

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
_______________________________________________________________________




1065. 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

Agency Contact: Lori LeGault, Nutritionist, Department of Health and 
Human Services, Food and Drug Administration, HFS-840, 5100 Paint 
Branch Parkway, College Park, MD 20740
Phone: 301 436-1791
Fax: 301 436-2635
Email: [email protected]

RIN: 0910-AF23
_______________________________________________________________________




1066. 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                     To Be                       Determined

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: None

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
_______________________________________________________________________




1067. 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

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                     To Be                       Determined

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: None

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

[[Page 64588]]

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

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




1068. 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: Next Action Undetermined

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: None

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
_______________________________________________________________________




1069. 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.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Action (Plaque Gingivitis)10/00/06

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: None

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
_______________________________________________________________________




1070. 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                     To Be                       Determined

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: None

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
_______________________________________________________________________




1071. 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 501; 21 USC 502; 21 USC 505; 21 USC 512; 21 USC 
516; 21 USC 519; 21 USC 701; 21 USC 704; 21 USC 801; 42 USC 351; 42 USC 
361

CFR Citation: 21 CFR 116; 21 CFR 226.60; 21 CFR 300.200; 21 CFR 500; 21 
CFR 600.16; 21 CFR 895; 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

[[Page 64589]]

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                             To Be                       Determined

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: 301 827-0891
Fax: 301 827-4774
Email: [email protected]

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




1072. LABEL REQUIREMENT FOR FOOD THAT HAS BEEN REFUSED ADMISSION INTO 
THE UNITED STATES

Priority: Other Significant

Legal Authority: 15 USC 1453 to 1455 ; 21 USC 321; 21 USC 343; 21 USC 
352; 21 USC 355; 21 USC 360b; 21 USC 362; 21 USC 371; 21 USC 374; 21 
USC 381; 42 USC 216; 42 USC 264

CFR Citation: 21 CFR 1.98

Legal Deadline: None

Abstract: The proposed rule would require owners or consignees to label 
imported food that is refused entry into the United States. The label 
would read, ``UNITED STATES: REFUSED ENTRY.'' The proposal would 
describe the label's characteristics (such as its size) and processes 
for verifying that the label has been affixed properly. We are taking 
this action to prevent the introduction of unsafe food into the United 
States, to facilitate the examination of imported food, and to 
implement section 308 of the Public Health Security and Bioterrorism 
Preparedness and Response Act of 2002 (the Bioterrorism Act) (Pub. L. 
107-188).

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                             To Be                       Determined

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: Undetermined

Agency Contact: Philip L. Chao, Senior Policy Analyst, Department of 
Health and Human Services, Food and Drug Administration, Room 15-61 
(HF-23), Office of Policy and Planning, 5600 Fishers Lane, Room 14C-17, 
Rockville, MD 20857
Phone: 301 827-0587
Fax: 301 827-4774
Email: [email protected]

RIN: 0910-AF61
_______________________________________________________________________




1073. [bull] 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 products.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Proposed Rule                   10/00/06

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Walter Ellenberg, Regulatory Health Project Manager, 
Center for Drug Evaluation and Research, Department of Health and Human 
Services, Food and Drug Administration, CRP2 RMS214, HFD-560, 
Rockville, MD 20850
Phone: 301 827-2279
Fax: 301-827-2316
Email: [email protected]

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




1074. [bull] LOWFAT AND SKIM MILK AND LOWFAT AND NONFAT YOGURT PRODUCTS, 
LOWFAT COTTAGE CHEESE: REV. OF STAND. OF IDENT.; FOOD LAB., NUTRIENT 
CONT. CLAIMS FOR FAT, FATTY ACIDS, AND CHOLESTEROL CONT. OF FOODS 
(SECTION 610 REVIEW)

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

Legal Authority: 21 USC 321; 21 USC 341; 21 USC 343; 21 USC 348; 21 USC 
371; 21 USC 379

CFR Citation: 21 CFR 101; 21 CFR 131; 21 CFR 133

Legal Deadline: None

Abstract: Part 131 (21 CFR Part 131) describes regulations for 
standards of identity for milk and milk products. Part 133 (21 CFR Part 
133) describes regulations for standards of identity for cheese and 
cheese products. The 1996 final rule (61 FR 58991) removed standards of 
identity for sweetened condensed skim milk, lowfat dry milk, evaporated 
skim milk, lowfat milk, acidified lowfat milk, skim (nonfat) milk, 
cultured skim (nonfat) milk, sour half-and-half, acidified sour half-
and-half, and lowfat cottage cheese. The final rule amended the 
standard of identity for dry cream by removing the reference to the 
lowfat milk standard. The regulation also amended the nutrient content 
claims regulations for fat, fatty acids, and cholesterol (part 101.62) 
to provide for ``skim'' as a synonym for ``nonfat'' when used in 
labeling milk products. The purpose of this review is to determine 
whether the regulations in parts 131 and 133 should be continued 
without change, or whether they 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

[[Page 64590]]

soliciting comments on, the following: (1) The continued need for the 
regulations in parts 131 and 133; (2) the nature of complaints or 
comments received concerning the regulations in parts 131 and 133; (3) 
the complexity of the regulations in parts 131 and 133; (4) the extent 
to which the regulations in parts 131 and 133 overlap, duplicate, or 
conflict 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 food standard regulations 
in parts 131 and 133.
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. The combined effect of 
the two reviews will be to determine if it is possible to redesign milk 
and cheese food standards of identity in ways that will maintain or 
increase the effectiveness of food labeling in providing useful 
information to consumers, and, at the same time, reduce compliance and 
other costs associated with the regulations.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Begin Review                    08/01/05
End Review                      12/00/06

Regulatory Flexibility Analysis Required: No

Government Levels Affected: Undetermined

Federalism:  Undetermined

Agency Contact: Richard A. Williams, Director, Division of Market 
Studies, OSAS, 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-AF64
_______________________________________________________________________




1075. [bull] 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 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 phenazopyridine.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM (Urinary Analgesic)        12/00/06

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Walter Ellenberg, Regulatory Health Project Manager, 
Center for Drug Evaluation and Research, Department of Health and Human 
Services, Food and Drug Administration, CRP2 RMS214, HFD-560, 
Rockville, MD 20850
Phone: 301 827-2279
Fax: 301-827-2316
Email: [email protected]

RIN: 0910-AF70
_______________________________________________________________________


Department of Health and Human Services (HHS)         Completed Actions


Food and Drug Administration (FDA)



_______________________________________________________________________




1076. REQUIREMENTS PERTAINING TO SAMPLING SERVICES AND PRIVATE 
LABORATORIES USED IN CONNECTION WITH IMPORTED FOOD

Priority: Routine and Frequent

CFR Citation: 21 CFR 59

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn                       08/05/05

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Philip L. Chao
Phone: 301 827-0587
Fax: 301 827-4774
Email: [email protected]

RIN: 0910-AB96
_______________________________________________________________________




1077. AMENDMENTS TO THE PERFORMANCE STANDARD FOR DIAGNOSTIC X-RAY 
SYSTEMS AND THEIR MAJOR COMPONENTS

Priority: Economically Significant. Major under 5 USC 801.

CFR Citation: 21 CFR 1020.30; 21 CFR 1020.31; 21 CFR 1020.32; 21 CFR 
1020.33

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    06/10/05                    70 FR 33998

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Myrna Hanna
Phone: 301 827-2971
Fax: 301 594-4765
Email: [email protected]

RIN: 0910-AC34
_______________________________________________________________________




1078. REGISTRATION OF FOOD AND ANIMAL FEED FACILITIES

Priority: Other Significant

CFR Citation: 21 CFR 1; 21 CFR 20

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Rule                      10/03/05                    70 FR 57505

Regulatory Flexibility Analysis Required: No

[[Page 64591]]

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Catherine Copp
Phone: 301 436-1589
Fax: 301 436-2637
Email: [email protected]

RIN: 0910-AC40
_______________________________________________________________________




1079. QUALITY STANDARD REGULATION ESTABLISHING AN ALLOWABLE LEVEL FOR 
ARSENIC IN BOTTLED WATER

Priority: Other Significant

CFR Citation: 21 CFR 165.110(b)

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Rule                      06/09/05                    70 FR 33694

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: Henry Kim
Phone: 301 436-2023
Fax: 301 436-2651
Email: [email protected]

RIN: 0910-AF10
_______________________________________________________________________


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


Health Resources and Services Administration (HRSA)



_______________________________________________________________________




1080. 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                     12/00/05

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

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
_______________________________________________________________________




1081. NATIONAL PRACTITIONER DATA BANK FOR ADVERSE INFORMATION ON 
PHYSICIANS AND OTHER HEALTH CARE PRACTITIONERS: REPORTING ADVERSE AND 
NEGATIVE ACTIONS

Priority: Substantive, Nonsignificant

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                            10/00/05

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
_______________________________________________________________________




1082. 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

[[Page 64592]]

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                            10/00/05

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
_______________________________________________________________________




1083. NATIONAL VACCINE INJURY COMPENSATION PROGRAM: CALCULATION OF 
AVERAGE COST OF A HEALTH INSURANCE POLICY

Priority: Info./Admin./Other

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, 
``lf, 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 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                            10/00/05

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
_______________________________________________________________________




1084. HEALTHY TOMORROW'S PARTNERSHIP FOR CHILDREN (HTPC) PROGRAM

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

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                            12/00/05

[[Page 64593]]

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Jose Belardo, Director, Healthy Tomorrow's Partnership 
for 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)          Final Rule Stage


Health Resources and Services Administration (HRSA)



_______________________________________________________________________




1085. INTERIM FINAL RULE FOR THE SMALLPOX EMERGENCY PERSONNEL PROTECTION 
PROGRAM: SMALLPOX (VACCINIA) VACCINE INJURY TABLE

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

Legal Authority: PL 108-20, 117 Stat 638

CFR Citation: 42 CFR 102

Legal Deadline: None

Abstract: To establish a table identifying adverse effects (including 
injuries, disabilities, conditions, and deaths) that shall be presumed 
to result from the administration of, or exposure to, the smallpox 
vaccine, and the time interval in which the first symptom or 
manifestation of each listed injury must manifest in order for such 
presumption to apply.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              08/27/03                    68 FR 51492
Final Action                    10/00/05

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Mr. Paul T. Clark, Director, Smallpox Vaccine Injury 
Compensation Program, Department of Health and Human Services, Health 
Resources and Services Administration, 11th Floor, 5600 Fishers Lane, 
Rockville, MD 20857
Phone: 301 443-5255
Email: [email protected]

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




1086. SMALLPOX VACCINE INJURY COMPENSATION PROGRAM: ADMINISTRATIVE 
IMPLEMENTATION

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

Legal Authority: PL 108-20, 117 Stat 638

CFR Citation: 42 CFR 102

Legal Deadline: None

Abstract: To provide benefits to certain persons harmed as a result of 
receiving smallpox covered countermeasures, including the smallpox 
vaccine, or as a result of contracting vaccinia through accidental 
exposure to certain persons. The Secretary may also provide death 
benefits to certain survivors of people who died as a direct result of 
these injuries.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              12/16/03                    68 FR 70080
Final Action                    10/00/05

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Mr. Paul T. Clark, Director, Smallpox Vaccine Injury 
Compensation Program, Department of Health and Human Services, Health 
Resources and Services Administration, 11th Floor, 5600 Fishers Lane, 
Rockville, MD 20857
Phone: 301 443-5255
Email: [email protected]

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




1087. 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 Action                    12/00/05

Regulatory Flexibility Analysis Required: No

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

[[Page 64594]]

Email: [email protected]

RIN: 0906-AA65
_______________________________________________________________________




1088. REVISION TO 42 CFR SUBPART D--PUBLIC HEALTH SERVICE (PHS) GRANT 
APPEALS PROCEDURE

Priority: Other Significant

Legal Authority: 42 USC 216

CFR Citation: 42 CFR 50.402

Legal Deadline: None

Abstract: The Health Resources and Services Administration (HRSA), an 
operating division under the U.S. Department of Health and Human 
Services, is proposing to no longer require its grantees to appeal 
certain adverse agency decisions to an ``informal'' appeals board (as 
outlined in 42 CFR part 50, subpart D--Public Health Service Grant 
Appeals Procedure) before exercising the right to appeal to the 
Departmental Appeals Board. In doing so, HRSA will join other PHS 
agencies (Substance Abuse and Mental Health Services Administration and 
the Indian Health Service) which no longer require the use of an 
informal appeal procedure.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/07/05                    70 FR 33053
NPRM Comment Period End         08/08/05
Final Rule                      06/00/06

Regulatory Flexibility Analysis Required: No

Government Levels Affected: Undetermined

Agency Contact: Gail Ellen Lipton, Director, Division of Grants Policy, 
Department of Health and Human Services, Health Resources and Services 
Administration, Room 11A-55, 5600 Fishers Lane, Rockville, MD 20857
Phone: 301 443-6509
Email: [email protected]

RIN: 0906-AA69
_______________________________________________________________________


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


Health Resources and Services Administration (HRSA)



_______________________________________________________________________




1089. 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
_______________________________________________________________________




1090. 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

[[Page 64595]]

_______________________________________________________________________


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


Indian Health Service (IHS)



_______________________________________________________________________




1091. SECTION 506--LIMITATION ON CHARGES FOR SERVICES FURNISHED BY 
MEDICARE PARTICIPATING INPATIENT HOSPITAL TO INDIANS

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

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                            12/00/05
NPRM Comment Period End         02/00/06
Final Action                    12/00/06

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)



_______________________________________________________________________




1092. [bull] GRANTS FOR RESEARCH PROJECTS -- 42 CFR PART 52-NPRM

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                            01/00/06

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, Room 601 MSC 
7669, 6011 Executive Boulevard, Rockville, MD 20852
Phone: 301 496-4606
Fax: 301 402-0169
Email: [email protected]

RIN: 0925-AA42
_______________________________________________________________________




1093. [bull] NATIONAL INSTITUTES OF HEALTH LOAN REPAYMENT PROGRAMS

Priority: Substantive, Nonsignificant

Legal Authority: 42 USC 216 42 USC 288-5a; 42 USC 287c-33 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 (LPR) authorities. This action will include 
rescinding the current regulations at 42 CFR 68a and at 42 CFR 68c in 
lieu of 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                            04/00/06

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, Room 601 MSC 
7669, 6011 Executive Boulevard, Rockville, MD 20852
Phone: 301 496-4606
Fax: 301 402-0169
Email: [email protected]

RIN: 0925-AA43
_______________________________________________________________________




1094. [bull] 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 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                            04/00/06

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, Room 601 MSC 
7669, 6011 Executive Boulevard, Rockville, MD 20852

[[Page 64596]]

Phone: 301 496-4606
Fax: 301 402-0169
Email: [email protected]

RIN: 0925-AA44
_______________________________________________________________________




1095. [bull] 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                            04/00/06

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, Room 601 MSC 
7669, 6011 Executive Boulevard, Rockville, MD 20852
Phone: 301 496-4606
Fax: 301 402-0169
Email: [email protected]

RIN: 0925-AA45
_______________________________________________________________________




1096. [bull] NATIONAL INSTITUTE OF ENVIRONMENTAL HEALTH SCIENCES 
HAZARDOUS SUBSTANCES BASIC RESEARCH AND TRAINING GRANTS

Priority: Substantive, Nonsignificant

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

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                            04/00/06

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, Room 601 MSC 
7669, 6011 Executive Boulevard, Rockville, MD 20852
Phone: 301 496-4606
Fax: 301 402-0169
Email: [email protected]

RIN: 0925-AA46
_______________________________________________________________________


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


National Institutes of Health (NIH)



_______________________________________________________________________




1097. NATIONAL INSTITUTES OF HEALTH TRAINING GRANTS

Priority: Substantive, Nonsignificant

Legal Authority: 42 USC 216; 42 USC 285g-10

CFR Citation: 42 CFR 63a

Legal Deadline: None

Abstract: NIH proposes to amend the training grants regulations to 
implement the new authority under section 452G of the Public Health 
Service (PHS) Act. This action is necessitated by enactment of the 
Children's Health Act of 2000. Section 1002 of this Act adds a new 
section 452G to the PHS Act that authorizes the Director of the 
National Institute of Child Health and Human Development, in 
consultation with the Administrator of the Health Resources and 
Services Administration, to support activities to provide for an 
increase in the number and size of institutional training grants 
supporting pediatric training.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            01/28/05                     70 FR 4080
Final Action                    01/00/06

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, Room 601 MSC 
7669, 6011 Executive Boulevard, Rockville, MD 20852
Phone: 301 496-4606
Fax: 301 402-0169
Email: [email protected]

RIN: 0925-AA28
_______________________________________________________________________




1098. 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.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

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

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

[[Page 64597]]

Government Levels Affected: None

Agency Contact: Jerry Moore, NIH Regulations Officer, Department of 
Health and Human Services, National Institutes of Health, Room 601 MSC 
7669, 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)



_______________________________________________________________________




1099. UNDERGRADUATE SCHOLARSHIP PROGRAM REGARDING PROFESSIONS NEEDED BY 
THE NATIONAL INSTITUTES OF HEALTH (NIH)

Priority: Substantive, Nonsignificant

CFR Citation: 42 CFR 68b

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn                       10/20/05

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

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

RIN: 0925-AA10
_______________________________________________________________________




1100. NATIONAL INSTITUTES OF HEALTH LOAN REPAYMENT PROGRAM FOR RESEARCH 
GENERALLY

Priority: Substantive, Nonsignificant

CFR Citation: 42 CFR 68d

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn                       08/05/05

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

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

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

RIN: 0925-AA18
_______________________________________________________________________




1101. NATIONAL INSTITUTES OF HEALTH AIDS RESEARCH LOAN REPAYMENT PROGRAM

Priority: Substantive, Nonsignificant

CFR Citation: 42 CFR 68

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn                       08/05/05

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-AA32
_______________________________________________________________________




1102. NATIONAL INSTITUTES OF HEALTH EXTRAMURAL LOAN REPAYMENT PROGRAM 
FOR CLINICAL RESEARCHERS

Priority: Substantive, Nonsignificant

CFR Citation: 42 CFR 68g

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn                       10/20/05

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-AA33
_______________________________________________________________________




1103. NATIONAL INSTITUTES OF HEALTH PEDIATRIC RESEARCH LOAN REPAYMENT 
PROGRAM

Priority: Substantive, Nonsignificant

CFR Citation: 42 CFR 68e

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn                       10/20/05

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-AA34
_______________________________________________________________________




1104. NATIONAL INSTITUTES OF HEALTH LOAN REPAYMENT PROGRAM FOR HEALTH 
DISPARITIES RESEARCH

Priority: Substantive, Nonsignificant

CFR Citation: 42 CFR 68f

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn                       10/20/05

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-AA35
_______________________________________________________________________




1105. NATIONAL INSTITUTES OF HEALTH CLINICAL RESEARCH LOAN REPAYMENT 
PROGRAM FOR INDIVIDUALS FROM DISADVANTAGED BACKGROUNDS

Priority: Substantive, Nonsignificant

CFR Citation: 42 CFR 68a

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn                       10/20/05

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Jerry Moore

[[Page 64598]]

Phone: 301 496-4606
Fax: 301 402-0169
Email: [email protected]

RIN: 0925-AA36
_______________________________________________________________________




1106. NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT 
CONTRACEPTION AND INFERTILITY RESEARCH LOAN REPAYMENT PROGRAM

Priority: Substantive, Nonsignificant

CFR Citation: 42 CFR 68c

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn                       10/20/05

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-AA41
_______________________________________________________________________


Department of Health and Human Services (HHS)             Prerule Stage


Office of Public Health and Science (OPHS)



_______________________________________________________________________




1107. 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                           06/00/06
ANPRM Comment Period End        09/00/06

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, Suite 200, The 
Tower Building, 1101 Wootten Parkway, Rockville, MD 20852
Phone: 240 453-6900
Fax: 301 402-2071

RIN: 0940-AA11
_______________________________________________________________________


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


Office of Public Health and Science (OPHS)



_______________________________________________________________________




1108. 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 section 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                    08/00/06

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, Suite 750, 1101 Wootten Parkway, Rockville, MD 20852
Phone: 240 453-8200

[[Page 64599]]

Fax: 301 443-5351

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




1109. 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 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                    03/00/06

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, Suite 200, The 
Tower Building, 1101 Wootten Parkway, Rockville, MD 20852
Phone: 240 453-6900
Fax: 301 402-2071

RIN: 0940-AA06
_______________________________________________________________________




1110. FEDERAL POLICY FOR THE PROTECTION OF HUMAN SUBJECTS TECHNICAL 
AMENDMENT

Priority: Substantive, Nonsignificant

Legal Authority: 5 USC 301; 42 USC 289; 42 USC 300v-1(b)

CFR Citation: 45 CFR 46

Legal Deadline: None

Abstract: This final rule amends the Department of Health and Human 
Services (HHS) regulations for the protection of human subjects by 
changing all references to the Office for Protection from Research 
Risks (OPRR) to the Office for Human Research Protections (OHRP) and 
revising the footnote at the end of 45 CFR 46.101(i) by deleting the 
references to research involving fetuses, pregnant women, or human in 
vitro fertilization and subpart B of 45 CFR part 46. This technical 
amendment is being made in conjunction with the other federal 
departments and agencies that have promulgated the Federal Policy for 
the Protection of Human Subjects.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Action                    11/00/05

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Michael A. Carome MD, Department of Health and Human 
Services, Office of Public Health and Science, Suite 200, The Tower 
Building, 1101 Wootten Parkway, Rockville, MD 20852
Phone: 240 453-6900
Fax: 301 402-2071

RIN: 0940-AA10
_______________________________________________________________________


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


Office of Public Health and Science (OPHS)



_______________________________________________________________________




1111. 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

________________________________________________________________________

NPRM                             To Be                       Determined

[[Page 64600]]

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Michael A. Carome MD, Department of Health and Human 
Services, Office of Public Health and Science, Suite 200, The Tower 
Building, 1101 Wootten Parkway, Rockville, MD 20852
Phone: 240 453-6900
Fax: 301 402-2071

RIN: 0940-AA08
_______________________________________________________________________


Department of Health and Human Services (HHS)         Completed Actions


Office of Public Health and Science (OPHS)



_______________________________________________________________________




1112. PUBLIC HEALTH SERVICE POLICIES ON RESEARCH MISCONDUCT

Priority: Other Significant

CFR Citation: 42 CFR 93

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    05/17/05                    70 FR 28370

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Chris Pascal
Phone: 240 453-8200
Fax: 301 443-5351

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


Department of Health and Human Services (HHS)             Prerule Stage


Centers for Medicare & Medicaid Services (CMS)



_______________________________________________________________________




1113. [bull] INNOVATIONS IN FEE-FOR-SERVICE PAYMENT SYSTEMS TO IMPROVE 
QUALITY AND OUTCOMES (CMS-1298-ANPR)

 Regulatory Plan: This entry is Seq. No. 50 in part II of this issue of 
the Federal Register.

RIN: 0938-AN91
_______________________________________________________________________


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


Centers for Medicare & Medicaid Services (CMS)



_______________________________________________________________________




1114. 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

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 the Administration's 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                     06/00/06

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses, Organizations

Government Levels Affected: None

Agency Contact: 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]

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
_______________________________________________________________________




1115. STANDARD UNIQUE NATIONAL HEALTH PLAN IDENTIFIER (CMS-6017-P)

Priority: Other Significant. Major under 5 USC 801.

Unfunded Mandates: This action may affect State, local or tribal 
governments.

Legal Authority: 42 USC 1320d to 1320d-8

[[Page 64601]]

CFR Citation: 45 CFR 160; 45 CFR 162

Legal Deadline: Final, Statutory, February 21, 1998.

Abstract: This proposed rule would implement a standard identifier to 
identify health plans that process and pay certain electronic health 
care transactions. It would implement one of the requirements for 
administrative simplification that have a national scope beyond 
Medicare and Medicaid.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/00/06

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: Helen Dietrick, 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: 410 786-7448

RIN: 0938-AH87
_______________________________________________________________________




1116. APPEALS OF CARRIER DETERMINATIONS THAT A SUPPLIER FAILS TO MEET 
THE REQUIREMENTS FOR MEDICARE BILLING PRIVILEGES (CMS-6003-P2)

Priority: Substantive, Nonsignificant

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

CFR Citation: 42 CFR 405.874

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                     02/00/06

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Michael Collett, 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: 410 786-6121
Email: [email protected]

RIN: 0938-AI49
_______________________________________________________________________




1117. 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.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/24/03                    68 FR 74792
Second NPRM                     04/00/06

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: Federal

Agency Contact: David Worgo, Health Insurance Specialist, Ambulatory 
Policy Group, Department of Health and Human Services, Centers for 
Medicare & Medicaid Services, Hospital and Ambulatory, Mailstop C4-15-
18, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-5919
Email: [email protected]

RIN: 0938-AJ17
_______________________________________________________________________




1118. USE OF RESTRAINTS AND SECLUSION IN MEDICARE AND MEDICAID 
PARTICIPATING FACILITIES THAT PROVIDE INPATIENT OR RESIDENTIAL CARE 
(CMS-2130-P)

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

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

CFR Citation: 42 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                            04/00/06

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected:  Businesses

Government Levels Affected: Undetermined

Federalism:  Undetermined

Agency Contact: Carla McGregor, Health Insurance Specialist, Survey and

[[Page 64602]]

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
_______________________________________________________________________




1119. REVISIONS TO CONDITIONS FOR COVERAGE FOR AMBULATORY SURGICAL 
CENTERS (CMS-3887-P)

Priority: Other Significant. Major under 5 USC 801.

Unfunded Mandates: Undetermined

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                            06/00/06

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]

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
_______________________________________________________________________




1120. 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: 42 CFR 162.1002; 42 CFR 162.1802

Legal Deadline: None

Abstract: This proposed rule would revise some of the electronic 
transactions and code set standards mandated by the Health Insurance 
Portability and Accountability Act of 1966.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            05/00/06

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
_______________________________________________________________________




1121. REQUIREMENTS FOR LONG-TERM CARE FACILITIES: HOSPICE SERVICES (CMS-
3140-P)

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

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 hospice 
agencies and long term care (LTC) facilities must meet 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                            05/00/06

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
_______________________________________________________________________




1122. COMPETITIVE ACQUISITION FOR CERTAIN DURABLE MEDICAL EQUIPMENT 
(DME), PROSTHETICS, ORTHOTICS, AND SUPPLIES AND RESIDUAL ISSUES (CMS-
1270-P)

 Regulatory Plan: This entry is Seq. No. 51 in part II of this issue of 
the Federal Register.

RIN: 0938-AN14
_______________________________________________________________________




1123. 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                            09/00/06

Regulatory Flexibility Analysis Required: Yes

[[Page 64603]]

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
_______________________________________________________________________




1124. PAYMENT FOR CLINICAL LABORATORY TESTS (CMS-1494-P)

Priority: Substantive, Nonsignificant

Legal Authority: Sec 1833(h)(8) of the MMA; Sec 416 of the MMA; PL 108-
173

CFR Citation: Not Yet Determined

Legal Deadline: Final, Statutory, July 1, 2004.

Abstract: The Medicare Modernization Act of 2003 (MMA), requires 
codification of the payment basis for determining Medicare payments for 
new clinical laboratory tests under the clinical laboratory fee 
schedule. Also, section 416 of the MMA eliminates the application of 
the clinical laboratory fee schedule for hospital outpatient laboratory 
testing by a hospital with fewer than 50 beds in a qualified rural area 
for cost reporting periods beginning during the two-year period 
beginning on July 1, 2004. Section 1833(h) of the Social Security Act 
mandates payment for outpatient clinical laboratory tests under a 
clinical laboratory fee schedule.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            05/00/06

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Anita Greenberg, Health Insurance Specialist, Center 
for Medicare Management, Department of Health and Human Services, 
Centers for Medicare & Medicaid Services, Mailstop C4-07-07, 7500 
Security Boulevard, Baltimore, MD 21244
Phone: 410 786-4601
Email: [email protected]

RIN: 0938-AN26
_______________________________________________________________________




1125. TERMINATION OF NON-RANDOM PREPAYMENT MEDICAL REVIEW (CMS-6022-F)

Priority: Other Significant

Legal Authority: Sec 934 of the MMA

CFR Citation: Not Yet Determined

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

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, 2004. 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
_______________________________________________________________________




1126. LIMITATION ON RECOUPMENT OF OVERPAYMENTS (CMS-6025-P)

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

Legal Authority: Section 935 of the MMA

CFR Citation: None

Legal Deadline: Final, Statutory, December 8, 2003.

Abstract: This proposed rule would implement one provision of section 
935 of the Medicare Modernization Act which added a new subsection to 
section 1893 of the Social Security Act. It would prohibit recoupment 
where a provider or supplier has appealed an overpayment determination 
until the reconsideration-level appeal is decided.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            07/00/06

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
_______________________________________________________________________




1127. 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.

Legal Authority: Social Security Act, sec 1864; Social Security Act, 
sec 1865; Social Security Act, sec 1875

CFR Citation: 42 CFR 488.1 to 488.9

Legal Deadline: None

Abstract: This proposed rule would respond to the recommendations in 
the GAO Report, ``CMS Needs Additional Authority to Adequately Oversee 
Patient Safety in Hospitals'' (GAO-04-850). With respect to the 
oversight and validation of hospital accreditation programs, a rate of 
disparity calculation is specified in Federal regulations at 42 CFR, 
488.8. This rule proposes to consider additional alternative measures 
to assess the performance of the accreditation organizations.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            07/00/06

Regulatory Flexibility Analysis Required: No

[[Page 64604]]

Small Entities Affected: No

Government Levels Affected: Undetermined

Agency Contact: Amber L. Wolfe, Health Insurance Specialist, Center for 
Medicaid and State Operations, Department of Health and Human Services, 
Centers for Medicare & Medicaid Services, Survey and Certification 
Group, Mailstop S2-12-25, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-6773
Email: [email protected]

RIN: 0938-AN62
_______________________________________________________________________




1128. PHYSICIANS' REFERRALS TO HEALTH CARE ENTITIES WITH WHICH THEY HAVE 
FINANCIAL RELATIONSHIPS; EXCEPTIONS FOR CERTAIN ELECTRONIC PRESCRIBING 
AND ELECTRONIC HEALTH RECORDS ARRANGEMENTS (CMS-1303-F)

Priority: Other Significant

Legal Authority: 1827(b)(4)-(b)(5); 1860D-4(e)(6); 1860D-42(e)(8)(B)

CFR Citation: 42 CFR 411.357

Legal Deadline: Final, Statutory, January 1, 2006.

Abstract: This rule proposes an exception to the physician self-
referral prohibition for certain nonmonetary remuneration related to 
electronic prescribing (section 1860D-4 of the Medicare Modernization 
Act).

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            10/07/05                    70 FR 59181
Final Action                    10/00/08

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Linda Howard, Health Insurance Specialist, Department 
of Health and Human Services, Centers for Medicare & Medicaid Services, 
C5-13-08, 7500 Security Boulevard, Baltimore, MD 21244-1850
Phone: 410 786-5255
Email: [email protected]

RIN: 0938-AN69
_______________________________________________________________________




1129. NATIONAL PLAN AND PROVIDER ENUMERATION SYSTEM (NPPES) DATA 
DISSEMINATION (CMS-6060-PN)

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

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 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 would describe the data 
dissemination strategy, processes, and any applicable charges for data.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Notice                          02/00/06

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Helen Dietrick, 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: 410 786-7448
Email: [email protected]

RIN: 0938-AN71
_______________________________________________________________________




1130. 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                            09/00/06

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Maria L. Hammel, 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: 410 786-1775
Email: [email protected]

RIN: 0938-AN73

[[Page 64605]]

_______________________________________________________________________




1131. HOME HEALTH PAYMENT SYSTEM RATE UPDATE FOR CALENDAR YEAR 2007 
(CMS-1304-P)

Priority: Economically Significant. Major under 5 USC 801.

Legal Authority: Social Security Act, sec 1895

CFR Citation: 42 CFR 484

Legal Deadline: Final, None, January 1, 2007, effective date.

Abstract: The proposed rule would set forth an update to the 60-day 
national episode rates and the national per-visit amounts under the 
Medicare prospective payment system for home health agencies, effective 
on January 1, 2007.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            03/00/06

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Federalism:  Undetermined

Agency Contact: Randy Throndset, Health Insurance Specialist, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, C5-07-28, 7500 Security Boulevard, Baltimore, MD 
21244
Phone: 410 786-0131
Email: [email protected]

RIN: 0938-AN76
_______________________________________________________________________




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: On July 16, 2004, GAO published a report on Federal fire 
safety standards and procedures in nursing facilities. The GAO Report 
recommended that CMS explore requiring sprinkler systems in all nursing 
facilities. This proposed rule would implement this regulation. We 
propose to require sprinkler systems in all long-term care facilities 
and solicit public comment regarding an appropriate and feasible phase-
in period for this regulation.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            03/00/06

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. INPATIENT PSYCHIATRIC FACILITY PROSPECTIVE PAYMENT SYSTEM--UPDATE 
FOR 2006 (CMS-1306-P)

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: None

Abstract: This rule would update the Inpatient Psychiatric Facility 
Prospective Payment System for 2006. This rule would update and revise 
the market basket and the use of new market area definitions.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            01/00/06

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected:  Businesses, Governmental Jurisdictions

Government Levels Affected: Local

Federalism:  Undetermined

Agency Contact: Paul Olenick, 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
Phone: 410 786-4533
Email: [email protected]

Janet Samen, Chronic Care Management and the Chronic Care Policy Group, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, Mailstop C5-05-07, 7500 Security Boulevard, 
Baltimore, MD 21244
Phone: 410 786-9161
Email: [email protected]

RIN: 0938-AN82
_______________________________________________________________________




1134. [bull] PROSPECTIVE PAYMENT SYSTEM FOR LONG-TERM CARE HOSPITALS FY 
2007: ANNUAL PAYMENT RATE UPDATES (CMS-1485-P)

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

Legal Authority: sec 123 PL 106-113; sec 307(b), PL 106-554

CFR Citation: 42 CFR 412

Legal Deadline: Final, Statutory, May 1, 2005, To be effective July 1, 
2005.

Abstract: This rule proposes the payment rate update for the 2007 
prospective payment system for Medicare long-term care hospitals. The 
new rates will be based on cost reports from the first LTC PPS rate 
year. (The proposed and final rules must be published by 5/1/06 to be 
effective 7/1/06.)

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            01/00/06

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Judith Richter, Health Insurance Specialist, Department 
of Health and Human Services, Centers for Medicare & Medicaid Services, 
7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-2590
Email: [email protected]

RIN: 0938-AO06
_______________________________________________________________________




1135. [bull] 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: Not Yet Determined

[[Page 64606]]

CFR Citation: Not Yet Determined

Legal Deadline: None

Abstract: This proposed rule would increase States' accountability for 
Federal Financial participation (FFP) provided for certain services 
furnished without charge to (but not limited to) the following groups: 
children residing in various foster care settings; juvenile offenders 
residing in detention, correctional, or shelter facilities; and others. 
The rule would clarify circumstances under which Federal financial 
participation (FFP) will or will not be made available to States on 
behalf of Medicaid beneficiaries in instances where the services are 
provided free of charge to all users in the community. The regulation 
would specify the criteria for determining when a service is free.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            08/00/06

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected:  Governmental Jurisdictions

Government Levels Affected: Undetermined

Federalism:  Undetermined

Agency Contact: Ellen W. Blackwell, Disability & Elderly Health 
Programs Group, Department of Health and Human Services, Centers for 
Medicare & Medicaid Services, Center for Medicaid State Operations, 
Mailstop S2-26-12, 7500 Security Boulevard, Baltimore, MD 21244-1850
Phone: 410 786-4498
Fax: 410 786-3262
Email: [email protected]

RIN: 0938-AO07
_______________________________________________________________________




1136. [bull] REVISIONS TO PAYMENT OF AMBULANCE SERVICES UNDER MEDICARE 
(CMS-1317-P)

Priority: Substantive, Nonsignificant

Legal Authority: Section 1834(1) of the Social Security Act (the Act).

CFR Citation: 42 CFR 414.605; 42 CFR 412.64; 42 CFR 410.40

Legal Deadline: None

Abstract: This rule would revise the fee schedule for payment of 
ambulance services specifically with respect to the definition of 
Specialty Care Transport (SCT) and the Metropolitan Statistical Area 
(MSA) geographic breakdown in relation to payment of ambulance services 
under Medicare. In addition, this proposed rule, discusses the 
conversion factor and the effect of low billers.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            01/00/06

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected:  Businesses

Government Levels Affected: None

Agency Contact: Anne Elizabeth Tayloe, Health Insurance Specialist, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, Mailstop C4-06-28, 7500 Security Boulevard, 
Baltimore, MD 21244-1850
Phone: 410 786-4546
Email: [email protected]

RIN: 0938-AO11
_______________________________________________________________________




1137. [bull] CHANGES TO THE HOSPITAL INPATIENT PROSPECTIVE PAYMENT 
SYSTEMS AND FY 2007 RATES (CMS-1488-P)

 Regulatory Plan: This entry is Seq. No. 52 in part II of this issue of 
the Federal Register.

RIN: 0938-AO12
_______________________________________________________________________




1138. [bull] REVISED PAYMENT SYSTEM FOR SERVICES FURNISHED IN AMBULATORY 
SURGICAL CENTERS (ASCS) EFFECTIVE JANUARY 1, 2008 (CMS-1517-P)

Priority: Economically Significant. Major under 5 USC 801.

Unfunded Mandates: Undetermined

Legal Authority: 42 CFR 416, Social Security Act 1832(2)(F) and 
1833(i), as amended by section 626 of the Medicare Modernization Act

CFR Citation: 42 FR 416

Legal Deadline: Final, Statutory, November 1, 2007.

Abstract: This rule, proposes to revise the method by which Medicare 
sets payment rates for ASC facility services, and will propose new 
payment rates for ASC services in accordance with that methodology. 
(Effective January 1, 2008).

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            04/00/06

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Organizations

Government Levels Affected: Federal

Federalism:  Undetermined

Agency Contact: Joan H. Sanow, Deputy Director, Division of Outpatient 
Care, Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, Center for Medicare Management, Mailstop C4-03-18, 
7500 Security Boulevard, Baltimore, MD 21244-1850
Phone: 410 786-9739
Fax: 410 786-4490
Email: [email protected]

RIN: 0938-AO13
_______________________________________________________________________




1139. [bull] CHANGES TO THE HOSPITAL OUTPATIENT PROSPECTIVE PAYMENT 
SYSTEM AND CALENDAR YEAR 2007 PAYMENT RATES (CMS-1506-P)

Priority: Substantive, Nonsignificant

Legal Authority: BBA; BBRA; BIPA; MMA

CFR Citation: 42 CFR 419 and 485

Legal Deadline: Final, None, November 1, 2006.

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 
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 payment system. These changes would be applicable to 
services furnished on or after January 1, 2007.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            07/00/06

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: Federal

[[Page 64607]]

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

Agency Contact: Rebecca Kane, Health Insurance Specialist, Center for 
Medicare Management, Hospital & Ambulatory Policy Group, Department of 
Health and Human Services, Centers for Medicare & Medicaid Services, 
Division Group of Outpatient Care, Mailstop C5-01-28, 7500 Security 
Boulevard, Baltimore, MD 21244-1850
Phone: 410 786-1589
Email: [email protected]

RIN: 0938-AO15
_______________________________________________________________________




1140. [bull] PROSPECTIVE PAYMENT SYSTEM FOR INPATIENT REHABILITATION 
FACILITIES FOR FY 2007 (CMS-1540-P)

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

Unfunded Mandates: Undetermined

Legal Authority: Section 1866(l) of the Social Security Act; ; PL 105-
33; PL 106-554; PL 106-113

CFR Citation: 42 CFR 412

Legal Deadline: Final, None, August 1, 2006.

Abstract: This proposed rule would update rates for the prospective 
payment system for inpatient rehabilitation facilities for FY 2007. 
(Effective October 1, 2006).

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            04/00/06

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Federalism:  Undetermined

Agency Contact: Robert Kuhl, Division Director of Center for Medicaid 
and Medicare, Department of Health and Human Services, Centers for 
Medicare & Medicaid Services, Mailstop C5-06-24, 7500 Security 
Boulevard, Baltimore, MD 21244-1850
Phone: 410 786-4597
Email: [email protected]

RIN: 0938-AO16
_______________________________________________________________________




1141. [bull] OUTPATIENT HOSPITAL SERVICES AND RURAL HEALTH CLINIC 
SERVICES AMENDMENT (CMS-2213-P)

Priority: Economically Significant. Major under 5 USC 801.

Legal Authority: Section 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                            08/00/06

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected:  Businesses

Government Levels Affected: None

Federalism:  Undetermined

Agency Contact: Jeremy Silanskis, Health Insurance Specialist, Center 
for Medicaid Services, 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
Phone: 410 786-1592
Fax: 410 786-8533
Email: [email protected]

RIN: 0938-AO17
_______________________________________________________________________




1142. [bull] FIVE YEAR REVIEW OF WORK RELATIVE VALUE UNITS UNDER THE 
PHYSICIAN FEE SCHEDULE (CMS-1512-PN)

Priority: Economically Significant. Major under 5 USC 801.

Unfunded Mandates: Undetermined

Legal Authority: Social Security Act sec 1848

CFR Citation: Not Yet Determined

Legal Deadline: Other, Statutory, April 2006, Proposed notice. Comments 
to be addressed as part of final physician fee.
Final, Statutory, November 1, 2006.

Abstract: This notice discusses changes to work relative value units 
(RVUs) affecting payment for physician services. Comments on this 
notice will be addressed as part of the final physician fee schedule 
rule required to be published by 11/01/06.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            04/00/06

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected:  Businesses

Government Levels Affected: Undetermined

Federalism:  Undetermined

Agency Contact: Diane Milstead, Health Insurance Specialist, Center of 
Medicare and Medicaid, Department of Health and Human Services, Centers 
for Medicare & Medicaid Services, Mailstop C4-03-06, 7500 Security 
Boulevard, Baltimore, MD 21244-1850
Phone: 410 786-3355
Email: [email protected]

RIN: 0938-AO22
_______________________________________________________________________




1143. [bull] REVISIONS TO PAYMENT POLICIES UNDER THE PHYSICIAN FEE 
SCHEDULE FOR CALENDAR YEAR 2007 (CMS-1321-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, 2006.

Abstract: This rule would make several changes affecting Medicare Part 
B payment. (The statute requires the final rule be published by 11/01/
06.)

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            07/00/06

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Federalism:  Undetermined

Agency Contact: Diane Milstead, Health Insurance Specialist, Center for 
Medicare and Medicaid Services, Department of Health and Human 
Services, Centers for Medicare &

[[Page 64608]]

Medicaid Services, Mailstop C4-03-06, 7500 Security Boulevard, 
Baltimore, MD 21244-1850
Phone: 410 786-3355
Email: [email protected]

RIN: 0938-AO24
_______________________________________________________________________




1144. [bull] 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 401.607, 42 CFR 401.601

Legal Deadline: Final, Statutory, December 9, 2003.

Abstract: This rule would implement a provision of section 935 of the 
MMA and adds a new subsection to section 1893 (42 U.S.C. 1395ddd) of 
the Social Security Act. The provision, ``Use of Repayment Plans,'' 
requires CMS to enter into a repayment plan with a provider or supplier 
when repaying a Medicare overpayment would be a hardship for the 
provider or supplier absent specific exceptions. The rule would 
establish criteria and procedures to apply this requirement to include 
the concepts of extreme hardship and the discretionary right to 
accelerate upon default.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            04/00/06

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
_______________________________________________________________________


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


Centers for Medicare & Medicaid Services (CMS)



_______________________________________________________________________




1145. REQUIREMENTS FOR ESTABLISHING AND MAINTAINING MEDICARE BILLING 
PRIVILEGES (CMS-6002-F)

Priority: Other Significant

Legal Authority: 42 USC 1302; 42 USC 1395hh

CFR Citation: 42 CFR 424

Legal Deadline: Final, Statutory, April 25, 2006, MMA 902.

Abstract: This final rule requires that all providers and suppliers 
(other than physicians who have elected to ``opt-out'' of the Medicare 
program) complete an enrollment form and submit specific information to 
CMS. This rule will requires that all providers and suppliers 
periodically update and certify the accuracy of their enrollment 
information to receive and maintain billing privileges in the Medicare 
program. In addition, this final rule will implement provisions in the 
Medicare statute that require CMS to ensure that all Medicare providers 
and suppliers are qualified to provide the appropriate health care 
services. These statutory provisions include requirements meant to 
protect beneficiaries and the Medicare Trust Funds by preventing 
unqualified, fraudulent, or excluded providers and suppliers from 
providing items or services to Medicare beneficiaries or billing the 
Medicare program or its beneficiaries.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            04/25/03                    68 FR 22064
Final Action                    04/00/06

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Michael Collett, Health Insurance Specialist, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, Office of Financial Management, Program Integrity 
Group, Division of Provider/Supplier Enrollment, N3-22-17, 7500 
Security Boulevard, Baltimore, MD 21244
Phone: 410 786-6121

RIN: 0938-AH73
_______________________________________________________________________




1146. 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 counseling; and maintain 
records for at least 10 years.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            11/16/00                    65 FR 69416
Interim Final Rule With Comment 03/00/06

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

[[Page 64609]]

_______________________________________________________________________




1147. MEDICARE HOSPICE CARE AMENDMENTS (CMS-1022-F)

Priority: Substantive, Nonsignificant

Legal Authority: PL 105-33, sec 1961(dd); PL 105-33, sec 1814(i); PL 
105-33, sec 4441 to 4444; PL 105-33, sec 4448; PL 106-113, sec 131; PL 
106-554, sec 321; PL 106-554, sec 322; PL 105-33, sec 4449

CFR Citation: 42 CFR 418

Legal Deadline: Final, Statutory, November 22, 2005, MMA 902.

Abstract: This final rule revises certain regulations governing 
coverage and payments for hospice care under the Medicare program as 
required by the Balanced Budget Act of 1997.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            11/22/02                    67 FR 70363
Final Action                    11/00/05

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Linda Smith, Health Insurance Specialist, Department of 
Health and Human Services, Centers for Medicare & Medicaid Services, 
Chronic Care Policy Group, Mailstop C5-02-24, 7500 Security Boulevard, 
Baltimore, MD 21244
Phone: 410 786-5650

Related RIN: Previously reported as 0938-AH73
RIN: 0938-AJ36
_______________________________________________________________________




1148. USE OF RESTRAINT 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; 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                    09/00/06

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Mary Clarkson, Health Insurance Specialist, Disabled & 
Elderly Health Programs Group, Department of Health and Human Services, 
Centers for Medicare & Medicaid Services, Division of Benefits & 
Coverage Policy, Mailstop S2-12-11, 7500 Security Boulevard, Baltimore, 
MD 21244-1850
Phone: 410 786-5918
Email: [email protected]

RIN: 0938-AJ96
_______________________________________________________________________




1149. ORGAN PROCUREMENT ORGANIZATION CONDITIONS FOR COVERAGE (CMS-3064-
IFR) (SECTION 610 REVIEW)

 Regulatory Plan: This entry is Seq. No. 53 in part II of this issue of 
the Federal Register.

RIN: 0938-AK81
_______________________________________________________________________




1150. PAYMENT FOR RESPIRATORY ASSIST DEVICES WITH BI-LEVEL CAPABILITY 
AND A BACK-UP RATE (CMS-1167-F)

Priority: Other Significant

Legal Authority: 42 USC 1395(m)(3)

CFR Citation: 42 CFR 414.222(a)(1)

Legal Deadline: Final, Statutory, August 22, 2006, MMA, section 902.

Abstract: This final rule clarifies that respiratory assist devices 
with bi-level capability and a back-up rate must be classified as 
capped rental durable medical equipment (DME) in accordance with 
section 1834(a)(3) of the Social Security Act (42 U.S.C. 1395(m)(3)).

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            08/22/03                    68 FR 50735
Final Action                    08/00/06

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Joel Kaiser, Health Insurance Specialist, Department of 
Health and Human Services, Centers for Medicare & Medicaid Services, 
Center for Medicare Management, Chronic Care Policy Group, Mailstop C5-
07-26, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-4499
Email: [email protected]

Related RIN: Related to 0938-AL27
RIN: 0938-AN02
_______________________________________________________________________




1151. ENHANCED DSH TREATMENT FOR CERTAIN HOSPITALS (CMS-2198-F)

Priority: Other Significant

Legal Authority: Section 1923(i) of the Social Security Act

CFR Citation: Not Yet Determined

Legal Deadline: None

Abstract: This rule implements section 1001(d) of the Medicare 
Modernization Act which requires States to report additional 
information about their disproportionate share hospital (DSH) programs 
to their annual report. This section also requires States to 
independently audit and submit these certified audits annually to the 
Secretary (effective December 8, 2003).

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            08/26/05                    70 FR 50262
Final Action                    09/00/06

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

[[Page 64610]]

Phone: 410 786-3263
Email: [email protected]

RIN: 0938-AN09
_______________________________________________________________________




1152. UPDATE OF THE LIST OF COVERED PROCEDURES FOR AMBULATORY SURGICAL 
CENTERS FOR 2005 (CMS-1478-IFC)

Priority: Other Significant

Legal Authority: Not Yet Determined

CFR Citation: None

Legal Deadline: Final, Statutory, July 1, 2005.

Abstract: This final rule updates the list of Medicare-covered ASC 
procedures.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            11/26/04                    69 FR 69178
Interim Final Rule              05/04/05                    70 FR 23690
Final Action                    01/00/06

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: None

Agency Contact: Dana Burley, Health Insurance Specialist, Department of 
Health and Human Services, Centers for Medicare & Medicaid Services, 
Center for Medicare Management, Hospital and Ambulatory Policy Group, 
Mailstop C4-05-17, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-4547
Email: [email protected]

RIN: 0938-AN23
_______________________________________________________________________




1153. MEDICARE SECONDARY PAYER AMENDMENTS (CMS-6272-IFC)

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: Section 301 of the Medicare Modernization Act clarifies when 
CMS may make a conditional Medicare payment when other insurance cannot 
reasonably be expected to make a prompt payment (effective December 8, 
2003).

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule With Comment 02/00/06

Regulatory Flexibility Analysis Required: No

Government Levels Affected: Undetermined

Agency Contact: Jeremy Silanskis, Health Insurance Specialist, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, Centers for Medicaid Services Office, Mail Stop S3-
13-15, 7500 Security Boulevard, Baltimore, MD 21244-1850
Phone: 410 786-1592
Fax: 410 786-8533
Email: [email protected]

RIN: 0938-AN27
_______________________________________________________________________




1154. HOME HEALTH PROSPECTIVE PAYMENT SYSTEM RATE UPDATE FOR CALENDAR 
YEAR 2006 (CMS-1301-F)

Priority: Economically Significant. Major under 5 USC 801.

Legal Authority: Sec 1895 of the Social Security Act

CFR Citation: 42 CFR 484

Legal Deadline: Final, Statutory, November 1, 2005.

Abstract: This rule updates the 60-day national episode rates and the 
national per-visit amounts under the Medicare prospective payment 
system for home health agencies.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            07/14/05                    70 FR 40788
Final Action                    11/00/05

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Agency Contact: Randy Throndset, Health Insurance Specialist, Division 
of Community Post Acute Care, Department of Health and Human Services, 
Centers for Medicare & Medicaid Services, Center for Medicare 
Management, C5-09-15, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-0131
Email: [email protected]

RIN: 0938-AN44
_______________________________________________________________________




1155. CHANGES TO THE HOSPITAL OUTPATIENT PROSPECTIVE PAYMENT SYSTEM AND 
CALENDAR YEAR 2006 PAYMENT RATES (CMS-1501-FC)

 Regulatory Plan: This entry is Seq. No. 54 in part II of this issue of 
the Federal Register.

RIN: 0938-AN46
_______________________________________________________________________




1156. ALL PROVIDER BAD DEBT PAYMENT (CMS-1126-F)

Priority: Other Significant

Legal Authority: SSA, sec 1834

CFR Citation: 42 CFR 412; 42 CFR 413; 42 CFR 1902

Legal Deadline: Final, Statutory, February 10, 2006, MMA sec. 902.

Abstract: This final rule will achieve a consistent bad debt 
reimbursement policy for all providers currently eligible to receive 
payments from Medicare for bad debt. It implements a court settlement 
agreement and removes the cap on End Stage Renal Disease (ESRD) bad 
debt reimbursement, which limits payment of allowable bad debts to the 
facility's unrecovered costs.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            02/10/03                     68 FR 6682
Final Action                    02/00/06

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: Federal

Agency Contact: Katie Walker, Health Insurance Specialist, Department 
of Health and Human Services, Centers for Medicare & Medicaid Services, 
Center of Medicare Management, Mailstop C5-03-03, 7500 Security 
Boulevard, Baltimore, MD 21244
Phone: 410 786-7278
Email: [email protected]

Related RIN: Related to 0938-AK02
RIN: 0938-AN75
_______________________________________________________________________




1157. 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

[[Page 64611]]

Legal Deadline: Final, Statutory, October 1, 2005.

Abstract: This rule requires States to estimate improper payments in 
the Medicaid program and the State Children's Health Insurance Program. 
The State level estimates will be used to produce estimates of improper 
payments for both Medicaid and SCHIP at the national level. These 
national level estimates will enable us to comply with the Improper 
Payments Information Act of 2002. The intended effect of this 
regulation is for States to produce estimates of improper payments for 
their Medicaid and SCHIP programs and identify existing and emerging 
vulnerabilities that can be effectively targeted for corrective actions 
by the States.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            08/27/04                    69 FR 52620
Interim Final Rule              10/05/05                    70 FR 58260
Final Action                    10/00/08

Regulatory Flexibility Analysis Required: No

Government Levels Affected: State

Agency Contact: Chrstine Jones, Division Director, Department of Health 
and Human Services, Centers for Medicare & Medicaid Services, Office of 
Financial Management, Mail stop C3-02-16, 7500 Security Boulevard, 
Baltimore, MD 21244
Phone: 410 786-3722
Email: [email protected]

Related RIN: Related to 0938-AM86
RIN: 0938-AN77
_______________________________________________________________________




1158. REVISIONS TO PAYMENT POLICIES UNDER THE PHYSICIAN FEE SCHEDULE FOR 
CALENDAR YEAR 2006 (CMS-1502-FC)

 Regulatory Plan: This entry is Seq. No. 55 in part II of this issue of 
the Federal Register.

RIN: 0938-AN84
_______________________________________________________________________




1159. [bull] FEE SCHEDULE FOR PAYMENT OF AMBULANCE SERVICES -- UPDATE 
FOR CY 2006 (CMS-1294-N)

Priority: Economically Significant. Major under 5 USC 801.

Unfunded Mandates: Undetermined

Legal Authority: Sec 1834(1) of the Social Security Act

CFR Citation: 42 CFR 410

Legal Deadline: None

Abstract: This notice updates the fee schedule for ambulance services 
under the Medicare program, implementing section 1834(1) of the Social 
Security Act. (effective January 1, 2006)

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Notice                          11/00/05

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Federalism:  Undetermined

Agency Contact: Anne Tayloe, Health Insurance Specialist, Department of 
Health and Human Services, Centers for Medicare & Medicaid Services, 
Center for Medicaid and State Operations, Mailstop C4-07-07, 7500 
Security Boulevard, Baltimore, MD 21244
Phone: 410 786-4546
Email: [email protected]

RIN: 0938-AN99
_______________________________________________________________________




1160. [bull] STATE ALLOTMENTS FOR PAYMENT OF MEDICARE PART B PREMIUMS 
FOR QUALIFYING INDIVIDUALS (CMS-2210-F)

Priority: Other Significant

Legal Authority: Section 4732 of the Balanced Budget Act of 1997 (PL 
105-33)

CFR Citation: Not Yet Determined

Legal Deadline: None

Abstract: Section 4732 of the Balanced Budget Act amended the Social 
Security Act to provide for certain low income Medicare Beneficiaries 
(also known as Qualified Individuals, or QIs) for whom Medicaid payment 
can be made for Medicare Part B premiums. Section 1933(c) of the Act 
limits the total amount of Federal funds available for payment of Part 
B premiums each fiscal year and specifies the formula to be used to 
determine an allotment for each State from this total amount. States 
must limit the number of QIs so that the amount of assistance provided 
during the fiscal year is approximately equal to the allotment for that 
year. For FY 2005 some States have experienced a deficit in their 
allotments which has necessitated denial of benefits to applicants 
after a certain date, while other States project that they will not 
utilize their full allotments. To fully utilize the authorized funding 
and to prevent denial of benefits to eligible applicants, the FY 2005 
funds will be reallocated based on current data available from States. 
This interim final rule with comment period announces the reallocation 
of funds available to States for FY 2005 and describes the methodology 
used to determine each State's allotment.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              08/26/05                    70 FR 50214
Comment Period End              10/25/05
Final Action                    08/00/08

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: State

Agency Contact: Richard Strauss, Technical Director Finance Systems & 
Budget Group, Department of Health and Human Services, Centers for 
Medicare & Medicaid Services, Center for Medicare State Operations, 
Mailstop S3-13-15, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-2019
Email: [email protected]

RIN: 0938-AO04
_______________________________________________________________________




1161. [bull] FEDERAL GOVERNMENT'S ADOPTION OF TWENTY (20) HEALTHCARE 
MESSAGING AND VOCABULARY STANDARDS RECOMMENDED BY THE CONSOLIDATED 
HEALTH INFORMATICS INITIATIVE (CMS-0015-N)

Priority: Other Significant

Legal Authority: Not Yet Determined

CFR Citation: None

Legal Deadline: None

Abstract: This notice identifies the 20 messaging and vocabulary 
standards adopted for use by the Federal government health information 
technology systems. The first set of 5 standards were adopted on 3/21/
03, and the second set of 15 standards were adopted on 5/6/04, which 
completed the initial portfolio of the Consolidated Health Informatics 
initiative.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Notice                          12/00/05

[[Page 64612]]

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: Federal

Agency Contact: Alicia Bradford, Office of HIPAA Standards, Director, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, 7500 Security Boulevard, Mailstop C5-25-04, 
Baltimore, MD 21244-1850
Phone: 410 786-4160

RIN: 0938-AO05
_______________________________________________________________________




1162. [bull] FIRE SAFETY REQUIREMENTS FOR RELIGIOUS NON-MEDICAL HEALTH 
CARE INSTITUTIONS: CORRECTION TO ADD WRITTEN FIRE CONTROL PLANS & 
MAINTENANCE OF DOCUMENTATION (CMS-3183-IFC)

Priority: Other Significant

Legal Authority: 42 USC.1395hh; 42 USC 1302

CFR Citation: 42 CFR 403

Legal Deadline: None

Abstract: On January 10, 2003, CMS issued a final rule amending the 
fire safety standards for religious non-medical health care 
institutions, hospices, programs of all-inclusive care for the elderly, 
hospitals, long-term care facilities, intermediate care facilities for 
the mentally retarded, and critical access hospitals. This final rule 
adopted, with certain exceptions, the 2000 edition of the Life Safety 
Code (LSC) published by the National Fire Protection Assoc. (NFPA). On 
August 11, 2004, the final Inpatient PPS rule was published. The LSC 
provisions in the August rule were meant to clarify the effective date 
of the roller latch prohibition. The clarifying regulatory language was 
accidentally deleted. These requirements will be restored by this 
regulation.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              06/00/06

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Janice A. Graham RN, Health Insurance Specialist, 
Clinical Standards Group, Department of Health and Human Services, 
Centers for Medicare & Medicaid Services, Office of Clinical Standards 
and Quality, Mailstop S3-02-01, 7500 Security Boulevard, Baltimore, MD 
21244-1850
Phone: 410 786-8020
Fax: 410 786-2532
Email: [email protected]

RIN: 0938-AO14
_______________________________________________________________________




1163. [bull] 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: Other Significant. Major under 5 USC 801.

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 1818 
A(d)(2)

CFR Citation: None

Legal Deadline: Final, Statutory, September 30, 2006.

Abstract: This notice announces the hospital insurance premium for 
Calendar Year 2007 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

________________________________________________________________________

Final Action                    09/00/06

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Clare McFarland, Division Director, Medicare and 
Medicaid Cost Estimates Group, Department of Health and Human Services, 
Centers for Medicare & Medicaid Services, Office of the Actuary, 
Mailstop N3-26-00, 7500 Security Boulevard, Baltimore, MD 21244-1850
Phone: 410 786-6390
Email: [email protected]

RIN: 0938-AO18
_______________________________________________________________________




1164. [bull] INPATIENT HOSPITAL DEDUCTIBLE AND HOSPITAL AND EXTENDED 
CARE SERVICES COINSURANCE AMOUNTS FOR CALENDAR YEAR 2007 (CMS-8029-N)

Priority: Other Significant. Major under 5 USC 801.

Legal Authority: 42 USC 1395e-2(b)(2); Social Security Act, section 
1813 (b)(2)

CFR Citation: None

Legal Deadline: Final, Statutory, September 15, 2006.

Abstract: This notice announces the inpatient hospital deductible and 
the hospital and extended care services coinsurance amounts for 
services furnished in Calendar Year 2007 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

________________________________________________________________________

Final Action                    09/00/06

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Clare McFarland, Division Director, Medicare and 
Medicaid Cost Estimates Group, Department of Health and Human Services, 
Centers for Medicare & Medicaid Services, Office of Actuary, Mailstop 
N3-26-00, 7500 Security Boulevard, Baltimore, MD 21244-1850
Phone: 410 786-6390
Email: [email protected]

RIN: 0938-AO19
_______________________________________________________________________




1165. [bull] FISCAL YEAR 2007 SCHIP ALLOTMENTS (CMS-2251-N)

Priority: Other Significant

Legal Authority: Title XXI of the Social Security Act, sec 2104

CFR Citation: 42 CFR 457

Legal Deadline: Final, Statutory, September 30, 2006.

Abstract: This notice sets forth the final 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

________________________________________________________________________

Final Notice                    06/00/06

[[Page 64613]]

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, 
Center for Medicaid State Operations, Mailstop S3-13-15, 7500 Security 
Boulevard, Baltimore, MD 21244-1850
Phone: 410 786-2019
Email: [email protected]

RIN: 0938-AO21
_______________________________________________________________________




1166. [bull] PART B MONTHLY ACTUARIAL RATES AND PREMIUM RATE BEGINNING 
JANUARY 1, 2007 (CMS-8030-N)

Priority: Other Significant

Legal Authority: 42 USC 1395r; Social Security Act, section 1839; MMA, 
section 629; MMA, section 811

CFR Citation: None

Legal Deadline: Final, Statutory, September 30, 2006.

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 2007. It also announces the monthly Part B premium to be 
paid by all enrollees, and the Part B deductible, during 2007.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Action                    09/00/06

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Suzanne Codespote, Division Director of Medicare and 
Medicaid Cost Estimates Group, Department of Health and Human Services, 
Centers for Medicare & Medicaid Services, Office of Actuary, Mailstop 
N3-26-00, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-7737
Email: [email protected]

RIN: 0938-AO23
_______________________________________________________________________




1167. [bull] 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.

Legal Authority: Social Security Act, sec 1888(e)

CFR Citation: 42 CFR 424

Legal Deadline: Other, Statutory, July 30, 2005, Notice must be 
published before August 1, 2006.

Abstract: This notice updates the payment rates used under the SNF PPS 
beginning 10/1/06.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Action                    07/00/06

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Agency Contact: Bill Ullman, Health Insurance Specialist, Division of 
Institutional Post Acute Care, Department of Health and Human Services, 
Centers for Medicare & Medicaid Services, Chronic Care Policy Group, 
Mailstop C5-07-08, 7500 Security Boulevard, Baltimore, MD 21244-1850
Phone: 410 786-5667
Email: [email protected]

RIN: 0938-AO25
_______________________________________________________________________




1168. [bull] HOSPICE WAGE INDEX FOR FY 2007 (CMS-1535-N)

Priority: Other Significant

Legal Authority: 1824 (i)(2)(D) of the Act; 1814 (i)(1)(A); 1814 
(i)(C)(ii)

CFR Citation: 42 CFR 418.306 (c)

Legal Deadline: Final, Statutory, September 1, 2006.

Abstract: This notice announces the annual update to the hospice wage 
index for FY 2007. 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

________________________________________________________________________

Final Action                    08/00/06

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected:  Businesses

Government Levels Affected: Undetermined

Federalism:  Undetermined

Agency Contact: Terri Deutsch, Health Insurance Specialist, Division of 
Community Post Acute Care, Department of Health and Human Services, 
Centers for Medicare & Medicaid Services, Hospital and Ambulatory 
Policy Group, Mailstop C5-08-18, 7500 Security Boulevard, Baltimore, MD 
21244-1850
Phone: 410 786-9462
Email: [email protected]

RIN: 0938-AO26
_______________________________________________________________________


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


Centers for Medicare & Medicaid Services (CMS)



_______________________________________________________________________




1169. 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 412 to 414; 42 
CFR 488; 42 CRR 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

[[Page 64614]]

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]

Robert Miller, Health Insurance Specialist, Department of Health and 
Human Services, Centers for Medicare & Medicaid Services, Clinical 
Standards Group, Division of Non-Institutional Quality Standards, S3-
04-25, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-6797
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
_______________________________________________________________________




1170. HOSPITAL CONDITIONS OF PARTICIPATION: REQUIREMENTS FOR APPROVAL 
AND RE-APPROVAL OF TRANSPLANT CENTERS TO PERFORM ORGAN TRANSPLANTS (CMS-
3835-F)

Priority: Other Significant

Legal Authority: 42 USC 1302; 42 USC 1395hh

CFR Citation: 42 USC 405; 42 USC 482; 42 USC 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
_______________________________________________________________________




1171. 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 would 
revise existing conditions of participation that hospices must meet to 
participate in the Medicare and Medicaid programs. The proposed 
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, allow hospices greater 
flexibility in meeting quality standards, and eliminate unnecessary 
procedural requirements.

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
Phone: 410 786-6051
Email: mary .[email protected]

RIN: 0938-AH27
_______________________________________________________________________




1172. MEDICARE OUTCOME AND ASSESSMENT INFORMATION SET (OASIS) DATA 
REPORTING REQUIREMENTS (CMS-3006-F)

Priority: Other Significant. Major under 5 USC 801.

Unfunded Mandates: This action may affect State, local or tribal 
governments and the private sector.

Legal Authority: 42 USC 1302; 42 USC 1395(hh)

CFR Citation: 42 CFR 484.11; 42 CFR 484.20; 42 CFR 488.68

Legal Deadline: Final, Statutory, December 8, 2006, MMA sec. 202.

Abstract: This final rule requires home health agencies to 
electronically report OASIS data as a condition of participation in the 
Medicare program.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              01/25/99                     64 FR 3748
Final Action                    12/00/06

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected:  Businesses

Government Levels Affected: Local, State, Tribal

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

Agency Contact: 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-AJ10
_______________________________________________________________________




1173. STANDARDS FOR ELECTRONIC HEALTH CARE CLAIM ATTACHMENTS (CMS-0050-
P)

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 claims

[[Page 64615]]

attachments. The standard is required by the Health Insurance 
Portability and Accountability Act of 1996. It will be used to transmit 
clinical data, in addition to the data contained in the claims 
standard, to help establish medical necessity 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: Lorraine Doo, Health Insurance Specialist, Office of E-
Health Standards and Services, Department of Health and Human Services, 
Centers for Medicare & Medicaid Services, Mailstop S-25-17, 7500 
Security Boulevard, Baltimore, MD 21244
Phone: 410 786-6597
Email: [email protected]

RIN: 0938-AK62
_______________________________________________________________________




1174. 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 final rule incorporates into regulation certain 
statutory provisions that preclude payment for services under Medicare 
if a physician makes a referral to a facility in which he or she has a 
financial interest. It addresses comments from the January 9, 1998 
proposed rule concerning the ownership, investment, and compensation 
exceptions. It also addresses comments from the January 4, 2001 final 
rule with comment period.

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
_______________________________________________________________________




1175. 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, 
C4-25-02, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-4477

RIN: 0938-AL54
_______________________________________________________________________




1176. 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                           12/00/07

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses, Organizations

Government Levels Affected: Federal, Local, State

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

Agency Contact: David Mlawsky, Health Insurance Specialist, Department 
of Health and Human Services, Centers for Medicare & Medicaid Services, 
Center for Beneficiary Choices, Medicare Plan Policy Group, Mailstop 
S3-16-26, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-6851
Email: [email protected]

RIN: 0938-AL88
_______________________________________________________________________




1177. ELECTRONIC MEDICARE CLAIMS SUBMISSION (CMS-0008-F)

Priority: Other Significant

Legal Authority: PL 107-105

CFR Citation: Not Yet Determined

Legal Deadline: Final, Statutory, December 8, 2006, MMA sec. 902.

[[Page 64616]]

Abstract: This final rule implements the requirements for electronic 
submission of Medicare claims, submitted on or after October 16, 2003. 
In addition, this rule also implements the conditions upon which a 
waiver could be granted for these requirements.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              08/15/03                    68 FR 48805
Interim Final Rule Comment 
Period End                      10/16/03
Final Action                    12/00/06

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: None

Agency Contact: Stewart Streimer, Director, Provider Billing Group, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, C4-10-07, 7500 Security Boulevard, Baltimore, MD 
21244
Phone: 410 786-9318
Email: [email protected]

RIN: 0938-AM22
_______________________________________________________________________




1178. REQUIREMENTS FOR LONG-TERM CARE FACILITIES; NURSING SERVICES; 
POSTING OF NURSE STAFFING INFORMATION (CMS-3121-F)

Priority: Other Significant

Legal Authority: Sec 1819(b) of the Social Security Act; 42 USC 1395i-
3(b)

CFR Citation: 42 CFR 483

Legal Deadline: Final, Statutory, February 27, 2007, MMA sec. 902.

Abstract: This final rule implements section 941 of the Medicare, 
Medicaid, and SCHIP Benefits Improvement and Protection Act of 2000 and 
requires nursing homes to post daily, for each shift, the number of 
registered nurses, licensed practical nurses, licensed vocational 
nurses, and certified nurse aides who are directly responsible for 
resident care.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            02/27/04                     69 FR 9282
NPRM Comment Period End         04/27/04
Final Action                    02/00/07

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

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, S3-02-01, 7500 Security Boulevard, Baltimore, 
MD 21244
Phone: 410 786-5646
Fax: 410 786-8532
Email: [email protected]

RIN: 0938-AM55
_______________________________________________________________________




1179. 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, June 30, 2008, MMA sec. 902.

Abstract: This final rule will revise 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
Interim Final Rule              06/30/05                    70 FR 37700
Final Action                    06/00/08

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]

Related RIN: Related to 0938-AK69
RIN: 0938-AM73
_______________________________________________________________________




1180. CONDITIONS FOR COVERAGE OF POWER MOBILITY DEVICES, INCLUDING 
POWERED WHEELCHAIRS AND POWER-OPERATED VEHICLES SCOOTER (CMS-3017-F)

Priority: Economically Significant. Major under 5 USC 801.

Legal Authority: Sec 1102 of the Social Security Act; Sec 1871 of the 
Social Security Act; 42 USC 1302 ; 42 USC 1359 hh

CFR Citation: 42 CFR 410.38

Legal Deadline: Final, Statutory, August 26, 2008, MMA sec. 902.

Abstract: This rule will make the requirements to purchase power 
operated vehicles, functioning as wheelchairs, less stringent. It 
expands who can order a Powered Operated Vehicle. It also requires a 
face-to-face examination of the beneficiary before ordering a device.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              08/26/05                    70 FR 50939
Final Rule                      08/00/08

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Karen Daily, Health Insurance Specialist Coverage & 
Analysis Group, Department of Health and Human Services, Centers for 
Medicare & Medicaid Services, Centers for Medicare and Medicaid 
Services, Mailstop C1-09-06, 7500 Security Boulevard, Baltimore, MD 
21244
Phone: 410 786-0189
Email: [email protected]

RIN: 0938-AM74
_______________________________________________________________________




1181. 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.

[[Page 64617]]

Abstract: This rule will reduce the burden on hospitals and allow 
hospitals to conform to current standards of practice. Hospitals would 
meet these final requirements to participate in Medicare and Medicaid. 
They must establish and maintain policies and procedures that would 
ensure their hospital would 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
_______________________________________________________________________




1182. 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, August 23, 2007, MMA sec. 902.

Abstract: This final rule proposes revisions to the CMS civil money 
penalty authorities. These proposed 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.

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

RIN: 0938-AM98
_______________________________________________________________________




1183. PRIOR DETERMINATION PROCESS FOR CERTAIN ITEMS AND SERVICES (CMS-
6024-P)

Priority: Other Significant

Legal Authority: Sec 938 of the Medicare Modernization Act of 2003

CFR Citation: Not Yet Determined

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 (effective 
June 8, 2005).

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: Misty D. Whitaker, Health Insurance Specialist, Office 
of Financial Management, Department of Health and Human Services, 
Centers for Medicare & Medicaid Services, Program Integrity Group, 
Office of Financial Management, Mail Stop C3-02-16, 7500 Security 
Boulevard, Baltimore, MD 21244
Phone: 410 786-3087
Email: [email protected]

RIN: 0938-AN10
_______________________________________________________________________




1184. NONDISCRIMINATION IN HEALTH COVERAGE AND WELLNESS PLANS IN THE 
GROUP MARKET (CMS-4081-F)

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

Legal Authority: 42 USC 300gg

CFR Citation: 45 CFR 146.121

Legal Deadline: Final, Statutory, December 8, 2006, MMA sec. 902.

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 (Code), 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 (CMS-2078-P).

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: David Mlawsky, Health Insurance Specialist, Department 
of Health and Human Services, Centers for Medicare & Medicaid Services, 
Center for Beneficiary Choices, Medicare Plan Policy Group, S3-16-26, 
7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-6851
Email: [email protected]

RIN: 0938-AN29

[[Page 64618]]

_______________________________________________________________________




1185. HOSPITAL CONDITIONS OF PARTICIPATION: PATIENTS' RIGHTS (CMS-3018-
F)

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

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 
used in the provision of acute medical and surgical care unless 
clinically necessary; and freedom from seclusion and restraint for 
behavior management unless clinically necessary.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              07/02/99                    64 FR 36069
Final Action                    12/00/06

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Janice Graham, Health Insurance Specialist, Department 
of Health and Human Services, Centers for Medicare & Medicaid Services, 
Office of Clinical Standards and Quality, Mailstop S3-05-27, 7500 
Security Boulevard, Baltimore, MD 21244
Phone: 410 786-8020
Email: [email protected]

RIN: 0938-AN30
_______________________________________________________________________




1186. FEDERAL ENFORCEMENT IN GROUP AND INDIVIDUAL HEALTH INSURANCE 
MARKETS (CMS-4091-F)

Priority: Other Significant

Legal Authority: 42 USC 300gg-22; 42 USC 300gg-31

CFR Citation: 45 CFR 150.101 to 150.465

Legal Deadline: None

Abstract: This rule finalizes, without any substantive changes, an 
interim final regulation (HCFA-2019-IFC) that sets forth the process by 
which CMS enforces the HIPAA title I requirements with regard to State 
and local governmental group health plans. It also finalizes the 
process by which CMS assumes direct enforcement responsibility in a 
State with regard to group and individual market health insurance 
issues.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              08/20/99                     64 FR 1999
Final Action                    12/00/06

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: Local, State

Agency Contact: David Mlawsky, Health Insurance Specialist, Department 
of Health and Human Services, Centers for Medicare & Medicaid Services, 
Center for Beneficiary Choices, Medicare Plan Policy Group, Mailstop 
S3-16-26, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-6851
Email: [email protected]

RIN: 0938-AN35
_______________________________________________________________________




1187. FIRE SAFETY REQUIREMENTS FOR CERTAIN HEALTH CARE FACILITIES; 
ALCOHOL-BASED HAND SANITIZER AMENDMENT (CMS-3145-F)

Priority: Other Significant

Legal Authority: Not Yet Determined

CFR Citation: 42 CFR 403; 42 CFR 416; 42 CFR 418; 42 CFR 460; 42 CFR 
482; 42 CFR 483; 42 CFR 485

Legal Deadline: Final, Statutory, March 25, 2008, MMA sec. 902.

Abstract: This final rule amends the fire safety standard for religious 
nonmedical health care institutions, hospices, programs of all-
inclusive care for the elderly, hospitals, long-term care facilities, 
intermediate care facilities for the mentally retarded, and critical 
access hospitals that participate in Medicare and Medicaid. The rule 
adopts a change made to the 2000 edition of the Life Safety Code (LSC) 
published by the National Fire Protection Association (NFPA). We 
adopted the 2000 edition of the LSC in January 2003. The LSC change 
will allow facilities to place alcohol-based hand sanitizer dispensers 
in exit corridors under certain conditions. These sanitizers have 
proven to be effective in increasing hand hygiene and have the 
potential to improve infection control practice. Adopting the LSC 
change will increase a provider's flexibility in meeting infection 
control goals while minimizing potential fire safety concerns. 
Additionally, this rule includes a requirement for placement of battery 
operated smoke alarms in resident rooms in non-sprinkled SNFs.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule With Comments03/25/05                    70 FR 15229
Final Action                    03/00/08

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Additional Information: Providers requesting publication of this 
regulation.

Agency Contact: Danielle 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
Email: [email protected]

RIN: 0938-AN36
_______________________________________________________________________




1188. REVISED CIVIL MONEY PENALTIES, ASSESSMENTS, EXCLUSIONS, AND 
RELATED APPEALS PROCEDURES (CMS-6019-F)

Priority: Other Significant

Legal Authority: PL 108-173, sec 949 of MMA

CFR Citation: 42 CFR 402.400

Legal Deadline: Final, Statutory, December 8, 2003.

Abstract: Section 949 of the Medicare Modernization Act changed the 
designation of authority to request waiver of a program exclusion under 
the Social Security Act from the State to the Administrator of a 
Federal health

[[Page 64619]]

care program. This rule proposes to outline a process for health care 
providers to follow if they wish CMS to request a waiver of exclusion 
on their behalf (effective December 8, 2003).

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            08/04/05                    70 FR 44879
Final Action                    08/00/08

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Joel Cohen, Health Insurance Specialist, Department of 
Health and Human Services, Centers for Medicare & Medicaid Services, 
Office of Financial Management, Program Integrity Group, 7500 Security 
Boulevard, Baltimore, MD 21244
Phone: 410 786-3349
Email: [email protected]

Related RIN: Merged with 0938-AM98
RIN: 0938-AN48
_______________________________________________________________________




1189. ELECTRONIC PRESCRIBING STANDARDS (CMS-0011-F)

Priority: Economically Significant. Major under 5 USC 801.

Legal Authority: 42 USC 1395

CFR Citation: None

Legal Deadline: Final, Statutory, September 1, 2005, Required e-
prescribing before outset of January 1, 2006, Medicare part D drug 
benefit.

Abstract: This final rule requires Medicare part D plans and Medicare 
Advantage Plans to support electronic transmission of basic 
prescription data to, and from, doctors and pharmacies, and to adopt a 
number of the initial standards required for electronic prescribing by 
section 1860(d) of the Medicare Modernization Act.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            02/04/05                     70 FR 6255
Final Action                    02/00/08

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: Gladys Wheeler, Health Insurance Specialist, Department 
of Health and Human Services, Centers for Medicare & Medicaid Services, 
7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-0273
Email: [email protected]

RIN: 0938-AN49
_______________________________________________________________________




1190. MEDICARE PART B COMPETITIVE ACQUISITION OF OUTPATIENT DRUGS AND 
BIOLOGICALS (CMS-1325-F)

Priority: Economically Significant. Major under 5 USC 801.

Legal Authority: MMA of 2003, sec 303(d)

CFR Citation: 42 CFR 414

Legal Deadline: Final, Statutory, January 1, 2006, MMA of 2003, section 
303(d) or section 1847(B)(a)(1) of the Social Security Act.

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 
January 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
Final Action                    07/00/08

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Edmund E. Kasaitis, Health Insurance Specialist, 
Hospital & Ambulatory Policy Group, Department of Health and Human 
Services, Centers for Medicare & Medicaid Services, Mailstop C4-01-26, 
7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-0477
Email: [email protected]

RIN: 0938-AN58
_______________________________________________________________________




1191. GROUP MARKET HEALTH INSURANCE REFORM: GUARANTEED AVAILABILITY, 
GUARANTEED RENEWABILITY, DISCLOSURES TO SMALL EMPLOYERS (CMS-4102-F)

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

Legal Authority: 42 USC 300gg-92

CFR Citation: 45 CFR 146.150; 45 CFR 146.152; 45 CFR 146.160

Legal Deadline: Final, Statutory, December 8, 2006, MMA sec. 902.

Abstract: This regulation finalizes the interim final regulation (BPD-
890-IFC) guaranteeing the availability of health insurance coverage to 
small employers, and guaranteeing the renewability of health insurance 
coverage to small and large employers.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Action                    12/00/06

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: David R. Mlawsky, Health Insurance Specialist, Center 
for Beneficiary Choices, Department of Health and Human Services, 
Centers for Medicare & Medicaid Services, Medicare Plan Policy Group, 
Mailstop S3-16-26, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 877 267-2323
Email: [email protected]

Related RIN: Related to 0938-AI08
RIN: 0938-AN60
_______________________________________________________________________




1192. INDIVIDUAL MARKET HEALTH INSURANCE REFORM: PORTABILITY FROM GROUP 
TO INDIVIDUAL COVERAGE; FEDERAL RULES FOR ACCESS IN THE INDIVIDUAL 
MARKET; STATE ALTERNATIVE MECHANISMS TO FEDERAL RULES (CMS-4103-F)

Priority: Other Significant. Major under 5 USC 801.

Legal Authority: 42 USC 300gg-92

CFR Citation: 42 CFR 148.11; 42 CFR 148.102; 42 CFR 148.103; 42 CFR 
148.122; 42 CFR 148.1

Legal Deadline: Final, Statutory, December 8, 2006, MMA sec. 902.

Abstract: This regulation finalizes the interim final rule (BPD-890-
IFC) that

[[Page 64620]]

guarantees availability of health coverage to certain individuals, 
guarantees renewability of coverage in the individual market, and sets 
standards for State alternative mechanisms for guaranteeing coverage to 
certain individuals.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Action                    12/00/06

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: David R. Mlawsky, Health Insurance Specialist, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, Center for Beneficiary Choices, Medicare Plan Policy 
Group, Mailstop S3-16-16, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 877 267-2323
Email: [email protected]

Related RIN: Related to 0938-AI08
RIN: 0938-AN61
_______________________________________________________________________




1193. 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: Not Yet Determined

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: Lauren Haley, Health Insurance Specialist, Department 
of Health and Human Services, Centers for Medicare & Medicaid Services, 
Centers for Medicare and Medicaid Services, Mailstop C3-02-16, 7500 
Security Boulevard, Baltimore, MD 21244-1850
Phone: 410 786-1730
Email: [email protected]

Related RIN: Related to 0938-AI09
RIN: 0938-AN72
_______________________________________________________________________




1194. APPLICATION OF INHERENT REASONABLENESS TO ALL MEDICARE PART B 
SERVICES (OTHER THAN PHYSICIAN SERVICES) (CMS-1908-F)

Priority: Info./Admin./Other. Major status under 5 USC 801 is 
undetermined.

Legal Authority: BBA; BBRA

CFR Citation: 42 CFR 405

Legal Deadline: Final, Statutory, December 8, 2006, MMA sec. 902.

Abstract: This rule finalizes the December 13, 2002, interim final rule 
and sets forth the process for establishing realistic and equitable 
payment amounts for all Medicare part B items and services (other than 
physician services) when the existing payment amounts are inherently 
unreasonable because they are either grossly excessive or grossly 
deficient. The rule describes the factors CMS (or its carriers) will 
consider, and the procedures that will be followed in establishing 
realistic and equitable payment amounts. This rule implements section 
4316 of the BBA, and section 223 of the BBRA that required CMS to 
publish this subsequent final rule.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              12/13/02                    67 FR 76684
Interim Final Rule Comment 
Period End                      02/11/03
Final Rule                      12/00/06

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Bill Long, Health Insurance Specialist, Department of 
Health and Human Services, Centers for Medicare & Medicaid Services, 
Center for Medicare Management, Mailstop C5-08-27, 7500 Security 
Boulevard, Baltimore, MD 21244
Phone: 410 786-5655
Email: [email protected]

RIN: 0938-AN81
_______________________________________________________________________




1195. 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 that 
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

Federalism:  Undetermined

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

[[Page 64621]]

_______________________________________________________________________




1196. ELECTRONIC SUBMISSION OF COST REPORTS: REVISION TO COST REPORTING 
PERIOD (CMS-1199-F)

Priority: Substantive, Nonsignificant

Legal Authority: None

CFR Citation: None

Legal Deadline: Final, Statutory, May 27, 2008, MMA sec. 902.

Abstract: This final rule follows a August 26, 2003, final rule that 
requires ESRD facilities, hospices, rural health clinics, federally 
qualified health centers, and community mental health centers to file 
cost reports in a standardized electronic format. It provided a delay 
or waiver of this requirement if implementation would result in 
financial hardship. Because the software packages for accepting the 
cost reports are not available yet, this final rule changes the cost 
report ending date from December 31, 2004, to March 31, 2005.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              05/27/05                    70 FR 30640
Final Action                    05/00/08

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Darryl E. Simms, Health Insurance Specialist, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, C5-03-30, 7500 Security Boulevard, Baltimore, MD 
21244
Phone: 410 786-4524
Email: [email protected]

Related RIN: Related to 0938-AL51
RIN: 0938-AN87
_______________________________________________________________________




1197. [bull] LOAN FORGIVENESS CRITERIA FOR THE HEALTH CARE 
INFRASTRUCTURE LOAN PROGRAM (CMS-1320-F)

Priority: Other Significant

Legal Authority: sec 1016 of PL 108-173

CFR Citation: 42 CFR 505

Legal Deadline: NPRM, Statutory, July 1, 2004.

Abstract: The Secretary is authorized to forgive such loans awarded in 
the Health Care Infrastructure Improvement Program if the hospital 
establishes an outreach program for cancer prevention, early diagnosis, 
and treatment for a substantial majority of the residents of the state, 
a similar program for multiple Indian tribes, and either unique 
research resources or an affiliation with an entity that has unique 
research resources.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/30/05                    70 FR 57376
Final Action                    09/00/08

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected:  Businesses

Government Levels Affected: None

Agency Contact: Tzvi Hefter, Director of the Division of Acute Care, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, Hospital and Ambulatory Policy Group, Mailstop C4-
01-17, 7500 Security Boulevard, Baltimore, MD 21244-1850
Phone: 410 786-4487
Email: [email protected]

RIN: 0938-AN93
_______________________________________________________________________




1198. [bull] HEALTH CARE INFRASTRUCTURE IMPROVEMENT PROGRAM; SELECTION 
CRITERIA OF LOAN PROGRAM FOR QUALIFYING HOSPITALS ENGAGED IN CANCER-
RELATED HEALTH CARE (CMS-1287-F)

Priority: Economically Significant. Major under 5 USC 801.

Legal Authority: Section 1016 of Public Law 108-173

CFR Citation: 42 CFR 505

Legal Deadline: Final, Statutory, July 1, 2004.

Abstract: This rule would establish a loan program to improve certain 
hospital infrastructure, including capital improvement. To receive 
assistance, the applicant would be required to: 1) Engage in cancer 
research; and 2) be designated by the National Cancer Institute (NCI) 
as a cancer center or by the State as the official cancer institute. No 
later than 4 years after enactment, the Secretary must submit a report 
to Congress summarizing the financial performance of the projects that 
have received assistance under the loan program.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              09/30/05                    70 FR 57368
Final Action                    09/00/08

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected:  Businesses

Government Levels Affected: None

Agency Contact: Melinda Jones, Health Insurance Specialist, Quality 
Measurement & Health Assessment Group, Department of Health and Human 
Services, Centers for Medicare & Medicaid Services, Mailstop S3-02-01, 
7500 Security Boulevard, Baltimore, MD 21244-1850
Phone: 410 786-7069
Email: [email protected]

Tzvi Hefter, Director of the Division of Acute Care, Department of 
Health and Human Services, Centers for Medicare & Medicaid Services, 
Mailstop C4-01-17, 7500 Security Boulevard, Baltimore, MD 21244-1850
Phone: 410 786-4487
Email: [email protected]

Related RIN: Related to 0938-AN93
RIN: 0938-AO03
_______________________________________________________________________




1199. [bull] 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

[[Page 64622]]

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                            10/00/06

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
_______________________________________________________________________


Department of Health and Human Services (HHS)         Completed Actions


Centers for Medicare & Medicaid Services (CMS)



_______________________________________________________________________




1200. SUPPLIER STANDARDS FOR HOME OXYGEN, THERAPEUTIC SHOES, AND HOME 
NUTRITION THERAPY (CMS-6010-P)

Priority: Substantive, Nonsignificant

CFR Citation: 42 CFR 424.57

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn                       06/28/05

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Ralph Goldberg
Phone: 410 786-4870

RIN: 0938-AJ98
_______________________________________________________________________




1201. EVALUATION CRITERIA AND STANDARDS FOR QUALITY IMPROVEMENT PROGRAM 
CONTRACTS (CMS-3142-FN)

Priority: Info./Admin./Other

CFR Citation: None

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    07/22/05                    70 FR 42331

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Maria L. Hammel
Phone: 410 786-1775
Email: [email protected]

RIN: 0938-AN13
_______________________________________________________________________




1202. NONDISCRIMINATION IN POST-HOSPITAL REFERRAL TO HOME HEALTH 
AGENCIES AND OTHER ENTITIES (CMS-1224-F)

Priority: Substantive, Nonsignificant

CFR Citation: 42 CFR 482

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn                       08/15/05

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Sarah Shipey
Phone: 410 786-0187

RIN: 0938-AN19
_______________________________________________________________________




1203. MEDICARE AMBULANCE FEE SCHEDULE UPDATE (CMS-1492-IFC)

Priority: Other Significant

CFR Citation: 42 CFR 414, subpart H

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn                       08/29/05

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: Local

Agency Contact: Robert Niemann
Phone: 410 786-4596
Email: [email protected]

Related RIN: Related to 0938-AO11
RIN: 0938-AN24
_______________________________________________________________________




1204. PROSPECTIVE PAYMENT SYSTEM FOR LONG TERM CARE HOSPITALS: ANNUAL 
PAYMENT RATE UPDATES AND POLICY CHANGES FOR 2006 (CMS-1483-F)

Priority: Economically Significant. Major under 5 USC 801.

CFR Citation: None

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    05/06/05                    70 FR 24168

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Judy Richter
Phone: 410 786-2590
Email: [email protected]

RIN: 0938-AN28
_______________________________________________________________________




1205. PROSPECTIVE PAYMENT SYSTEM FOR INPATIENT REHABILITATION FACILITIES 
FOR FY 2006 (CMS-1290-F)

Priority: Economically Significant. Major under 5 USC 801.

CFR Citation: None

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

NPRM                            05/25/05                    70 FR 30187
Final Action                    08/15/05                    70 FR 47879

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Robert Kuhl
Phone: 410 786-4597
Email: [email protected]

RIN: 0938-AN43

[[Page 64623]]

_______________________________________________________________________




1206. DEVELOPMENT OF NEW STANDARDS FOR MEDIGAP POLICIES (CMS-4087-FN)

Priority: Substantive, Nonsignificant

CFR Citation: None

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn                       05/27/05

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Julie Walton
Phone: 410 786-4622
Email: [email protected]

Related RIN: Related to 0938-AN08
RIN: 0938-AN50
_______________________________________________________________________




1207. FISCAL YEAR 2006 SCHIP ALLOTMENTS (CMS-2219-N)

Priority: Other Significant

CFR Citation: 42 CFR 457

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Notice                          06/24/05                    70 FR 36615

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-AN56
_______________________________________________________________________




1208. CHANGES TO THE HOSPITAL INPATIENT PROSPECTIVE PAYMENT SYSTEM AND 
FY 2006 RATES (CMS-1500-F)

Priority: Economically Significant. Major under 5 USC 801.

CFR Citation: 42 CFR 412; 42 CFR 413; 42 CFR 485; 42 CFR 489

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

NPRM                            05/04/05                    70 FR 23306
Final Action                    08/12/05                    70 FR 47277

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: Federal

Agency Contact: Marc Hartstein
Phone: 410 786-6192
Email: [email protected]

RIN: 0938-AN57
_______________________________________________________________________




1209. SPECIAL PAYMENT PROVISIONS AND STANDARDS FOR SUPPLIERS OF CUSTOM 
FABRICATED ORTHOTICS AND PROSTHETICS (CMS-6012-P)

Priority: Economically Significant. Major under 5 USC 801.

CFR Citation: 42 CFR 410; 42 CFR 414; 42 CFR 424

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn                       06/28/05

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Theresa Linkowich
Phone: 410 786-9249
Email: [email protected]

Ralph Goldberg
Phone: 410 786-8864

RIN: 0938-AN63
_______________________________________________________________________




1210. PROSPECTIVE PAYMENT SYSTEM AND CONSOLIDATED BILLING FOR SKILLED 
NURSING FACILITIES--UPDATE FOR FY 2006 (CMS-1282-F)

Priority: Economically Significant. Major under 5 USC 801.

CFR Citation: 42 CFR 409; 42 CFR 411; 42 CFR 424; 42 CFR 489

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

NPRM                            05/19/05                    70 FR 29069
Final Action                    08/04/05                    70 FR 45025

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses, Organizations

Government Levels Affected: None

Agency Contact: Bill Ullman
Phone: 401 786-5667
Email: [email protected]

RIN: 0938-AN65
_______________________________________________________________________




1211. STATE CHILDREN'S HEALTH INSURANCE PROGRAM (SCHIP); REDISTRIBUTION 
OF UNEXPENDED SCHIP FUNDS FROM THE APPROPRIATION FOR FISCAL YEAR (FY) 
2002 (CMS-2230-FN)

Priority: Other Significant

CFR Citation: 42 CFR 457.600 to 457.630

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    09/29/05                    70 FR 56901

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-AN78
_______________________________________________________________________




1212. EXTENDING SUNSET DATE FOR THE INTERIM FINAL REGULATION ON MENTAL 
HEALTH PARITY (CMS-4094-F3)

Priority: Other Significant

CFR Citation: 42 CFR 146

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    07/22/05                    70 FR 42276

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: David Mlawsky
Phone: 410 786-6851
Email: [email protected]

Related RIN: Related to 0938-AN22
RIN: 0938-AN80
_______________________________________________________________________




1213. [bull] DISPROPORTIONATE SHARE HOSPITAL PAYMENTS--INSTITUTIONS FOR 
MENTAL DISEASE (IMDS) (CMS-2062-N2)

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Duplicate of 0938-AN96          05/24/05

RIN: 0938-AN88

[[Page 64624]]

_______________________________________________________________________




1214. [bull] HOSPICE WAGE INDEX FOR FY 2006 (CMS-1286-F)

Priority: Other Significant

Legal Authority: Sec. 408 and 946 of the MMA of 2003;; Sec. 1861(dd) of 
the Social Security Act

CFR Citation: 42 CFR 418.306c

Legal Deadline: Final, None, August 2005, Rates are updated October 1st 
of each year-need at least 3 months to implement.

Abstract: This rule announces the annual update to the hospice wage 
index for FY 2006. 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

________________________________________________________________________

NPRM                            04/29/05                    70 FR 22393
Final Action                    08/04/05                    70 FR 45129

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Terri Deutsch, Health Insurance Specialist, Division of 
Community Post Acute Care, Department of Health and Human Services, 
Centers for Medicare & Medicaid Services, Hospital and Ambulatory 
Policy Group, Mailstop C5-08-28, 7500 Security Boulevard, Baltimore, MD 
21244
Phone: 410 786-9462
Email: [email protected]

RIN: 0938-AN89
_______________________________________________________________________




1215. [bull] INPATIENT REHABILITATION FACILITY CLASSIFICATION RULE 
COMPLIANCE (CMS-1480-N)

Priority: Other Significant

Legal Authority: Public Law 108-477, In accordance with the 
Consolidated Appropriations Act of 2005

CFR Citation: 420CFR 412.23(b)(2)

Legal Deadline: None

Abstract: In accordance with the provisions of the Consolidated 
Appropriations Act of 2005, the notice announces the Secretary's 
determination that the requirements for classification as an inpatient 
rehabilitation facility (IRF) specified in section 412.23(b)(2) were 
inconsistent with a report that the Government Accountability Office 
(GAO) issued concerning classification of a facility as an IRF.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Notice                          06/24/05                    70 FR 36640

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses, Governmental Jurisdictions

Government Levels Affected: Federal, Local, State

Agency Contact: Robert Kuhl, Division Director, Chronic Care Policy 
Group, Division of Institutional Post Acute Care, Department of Health 
and Human Services, Centers for Medicare & Medicaid Services, Centers 
for Medicare Management, Mailstop C5-26-07, 7500 Security Boulevard, 
Baltimore, MD 21244
Phone: 410 786-4597
Email: [email protected]

RIN: 0938-AN92
_______________________________________________________________________




1216. [bull] WITHDRAWAL OF AMBULANCE FEE SCHEDULE ISSUED IN ACCORDANCE 
WITH FEDERAL DISTRICT COURT ORDER IN LIFESTAR AMBULANCE, INC. V. U.S.--
MEDICARE COVERED AMBULANCE SERVICES (CMS-1308-)

Priority: Info./Admin./Other

Legal Authority: None

CFR Citation: None

Legal Deadline: None

Abstract: This notice would withdraw the fee schedule that was put in 
place to effect compliance with the Court Order in Lifestar Ambulance, 
Inc. v. United States. That Order was vacated by the U.S. Court of 
Appeals for the Eleventh Circuit in Lifestar Ambulance Service, Inc. v. 
United States and, accordingly, is no longer in force.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Notice                          09/01/05                    70 FR 52105

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Ann Tayloe, Health Insurance Specialist, CMS/CMM/HAPG/
DAS, Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, 7500 Security Boulevard, C4-07-07, Baltimore, MD 
21244
Phone: 410 786-7452
Email: [email protected]

RIN: 0938-AN94
_______________________________________________________________________




1217. [bull] IMMUNIZATION STANDARD FOR LONG TERM CARE FACILITIES (CMS-
3198-F)

Priority: Economically Significant. Major under 5 USC 801.

Legal Authority: 42 USC 1395i-3; SSA 1819 ; 42 USC 1396r; SSA 1919

CFR Citation: 42 CFR 483

Legal Deadline: None

Abstract: This rule would mandate nursing facilities to immunize each 
resident for influenza and pneumonia and would reinforces the 
residents' rights to receive the immunizations for vaccine-preventable 
diseases. The residents will have the right to refuse the 
immunizations, if they choose to or if contraindication exist.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            08/15/05                    70 FR 47759
Final Action                    10/07/05                    70 FR 58834

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

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-AN95
_______________________________________________________________________




1218. [bull] DISPROPORTIONATE SHARE HOSPITAL PAYMENTS -- INSTITUTIONS 
FOR MENTAL DISEASE (IMDS) (CMS-2209-N)

Priority: Other Significant

Legal Authority: 42 USC 1396r-4; PL 108-173, Sec 1001(a)

CFR Citation: None

Legal Deadline: None

[[Page 64625]]

Abstract: Section 1001(a) of the MMA amended the Act to revise the 
methodology for calculating States Disproportionate Share Hospital 
(DSH) allotments. CMS published a notice describing this methodology 
and States' preliminary FY 2003, and 2004 DSH allotments and 
preliminary FY 2003 and 2004 IMD DSH limits in the Federal Register on 
3/26/04. This notice announces the final Federal DSH allotments for 
Federal fiscal years (FFYs) 2003 and 2004, and the preliminary Federal 
share DSH allotments for FFY 2005. It also announces the final FFYs 
2003 and 2004, and the preliminary FFY 2005, limitations on aggregate 
DSH payments that States may make to institutions for mental disease 
and other mental health facilities. This notice also includes a 
background describing the methodology for determining the amounts of 
States' FFY DSH allotments for FFY 1998 and thereafter.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Notice                          08/26/05                    70 FR 50358

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Richard Strauss, Technical Director, Department of 
Health and Human Services, Centers for Medicare & Medicaid Services, 
Centers for Medicaid Operations Services, Mailstop S3-13-15, 7500 
Security Boulevard, Baltimore, MD 21244
Phone: 410 786-2019
Email: [email protected]

Related RIN: Previously reported as 0938-AN88
RIN: 0938-AN96
_______________________________________________________________________




1219. [bull] MEDICARE PRESCRIPTION DRUG DISCOUNT CARD (CMS-4063-F)

Priority: Other Significant

Legal Authority: SSA 1851(d)(1) ; SSA 1860D-1(c); SSA 1860D-
31(h)(7)(B); SSA 1860D-31(h)(8)

CFR Citation: 42 CFR 403; 42 CFR 408

Legal Deadline: None

Abstract: The regulation will finalize the marketing rules for the drug 
card program; specifically it will provide current drug card sponsors 
who become prescription drug plans (PDPs) the ability to market their 
PDP offerings to their current Medicare members. CMS is making the 
change because the current regulation provides that an endorsed 
sponsor's information and outreach materials may describe only those 
products or services within the scope of the Medicare endorsement for 
the drug card. The intended effect is to increase Medicare 
beneficiaries' awareness and knowledge of PDP offerings for Part D 
enrollment effective in 2006. The current draft of the marketing 
section in the interim final rule contradicts the intention of the 
Medicare Modernization Act to facilitate efficient enrollment into Part 
D. The revised final rule will reflect the actual intention of the law.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Action                    09/01/05                    70 FR 52019

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Jessica Shapiro, Acting Director, of the Division of 
Drug Card Management, Department of Health and Human Services, Centers 
for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, 
MD 21244
Phone: 410 786-7407
Fax: 410 786-1048

Related RIN: Related to 0938-AM71
RIN: 0938-AN97
_______________________________________________________________________




1220. [bull] INPATIENT HOSPITAL DEDUCTIBLE AND HOSPITAL AND EXTENDED 
CARE SERVICES COINSURANCE AMOUNTS FOR CALENDAR YEAR 2006 (CMS-8026-N)

Priority: Economically Significant. Major under 5 USC 801.

Legal Authority: 42 USC 1395e-2(b)(2); Sec 1813(b)(2) of the Social 
Security Act

CFR Citation: None

Legal Deadline: NPRM, Statutory, September 15, 2005.

Abstract: This notice announces the inpatient hospital deductible and 
the hospital and extended care services coinsurance amounts for 
services furnished in calendar year 2006 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                          09/23/05                    70 FR 55885

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Clare McFarland, Division Director, Medicare and 
Medicaid Cost Estimates Group, Department of Health and Human Services, 
Centers for Medicare & Medicaid Services, N3-26-00, Office of the 
Actuary, 7500 Security Boulevard, Mailstop N3-26-00, Baltimore, MD 
21244
Phone: 410 786-6390
Email: [email protected]

RIN: 0938-AO00
_______________________________________________________________________




1221. [bull] PART A PREMIUMS FOR CALENDAR YEAR 2006 FOR THE UNINSURED 
AGED AND FOR CERTAIN DISABLED INDIVIDUALS WHO HAVE EXHAUSTED OTHER 
ENTITLEMENT (CMS-8025-N)

Priority: Economically Significant. Major under 5 USC 801.

Legal Authority: 42 USC 1395i-2(d)(2); 42 USC 1395i thru 2a(d)(2); Sec 
1818(d)(2) of the Social Security Act; Sec 1818A(d)(2) of the Social 
Security Act

CFR Citation: None

Legal Deadline: None

Abstract: This notice announces the hospital insurance premium for 
Calendar Year 2006 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                          09/23/05                    70 FR 55896

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Clare McFarland, Division Director, Medicare and 
Medicaid Cost Estimates Group, Department of Health and Human

[[Page 64626]]

Services, Centers for Medicare & Medicaid Services, Office of the 
Actuary, 7500 Security Boulevard, Mailstop N3-26-00, Baltimore, MD 
21244
Phone: 410 786-6390
Email: [email protected]

RIN: 0938-AO01
_______________________________________________________________________




1222. [bull] MEDICARE PART B MONTHLY ACTUARIAL RATES AND PREMIUM RATE 
BEGINNING JANUARY 1, 2006 (CMS-8027-N)

Priority: Economically Significant. Major under 5 USC 801.

Legal Authority: 42 USC 1395r; Sec 1839 of the Social Security Act; Sec 
629 of MMA; Sec 811 of MMA

CFR Citation: None

Legal Deadline: None

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 2006. It also announces the monthly Part B premium to be 
paid by all enrollees, and the Part B deductible, during 2006. Section 
629 of the Medicare Modernization Act requires indexing the Part B 
deductible to the increase in the Part B aged actuarial rate beginning 
1/1/06.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Notice                          09/23/05                    70 FR 55897

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Suzanne Codespote, Division Director, Medicare and 
Medicaid Cost Estimates Group, Department of Health and Human Services, 
Centers for Medicare & Medicaid Services, Office of the Actuary, 7500 
Security Boulevard, Mailstop N3-26-00, Baltimore, MD 21244
Phone: 410 786-7737
Email: [email protected]

RIN: 0938-AO02
_______________________________________________________________________


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


Administration for Children and Families (ACF)



_______________________________________________________________________




1223. 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                            11/00/05

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
_______________________________________________________________________




1224. 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                            12/00/05

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, ADD HHH-
300F, 370 L'Enfant Promenade SW., Washington, DC 20447
Phone: 202 690-5841

RIN: 0970-AC07
_______________________________________________________________________




1225. ADMINISTRATIVE COST SHARING UNDER TANF

Priority: Substantive, Nonsignificant

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,

[[Page 64627]]

the Medicaid program, and the Food Stamp programs.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/00/05

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: Local, State

Agency Contact: Grant Collins, Deputy Director, 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
_______________________________________________________________________




1226. 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                            11/01/05

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
_______________________________________________________________________




1227. 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                            12/00/05

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: State

Agency Contact: Kathleen McHugh, Divison Director, Children's Bureau 
Policy, Department of Health and Human Services, Administration for 
Children and Families, Room 2411, 330 C Street SW., Washington, DC 
20447
Phone: 202 401-5789
Fax: 202 205-8221
Email: [email protected]

RIN: 0970-AC21
_______________________________________________________________________




1228. MEDICAL SUPPORT

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

Legal Authority: 42 USC 1302

CFR Citation: 45 CFR 302; 45 CFR 303; 45 CFR 304; 45 CFR 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                            12/00/05

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. [bull] 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 (P.L. 108-145).

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            02/00/06

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: State

Agency Contact: Kathleen McHugh, Divison Director, Children's Bureau 
Policy, Department of Health and Human Services, Administration for 
Children and Families, Room 2411, 330 C Street SW., Washington, DC 
20447
Phone: 202 401-5789
Fax: 202 205-8221
Email: [email protected]

RIN: 0970-AC23

[[Page 64628]]

_______________________________________________________________________


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


Administration for Children and Families (ACF)



_______________________________________________________________________




1230. ADMINISTRATIVE COSTS FOR CHILDREN IN TITLE IV-E FOSTER CARE

Priority: Other Significant

Legal Authority: 42 USC 672; 42 USC 674; 42 USC 1302

CFR Citation: 45 CFR 1356.60(c)

Legal Deadline: None

Abstract: This notice of proposed rulemaking implements the title IV-E 
foster care eligibility and administrative cost provisions in sections 
472 and 474 of the Social Security Act. We propose to prohibit the 
reimbursement of administrative costs claimed on behalf of children in 
unlicensed foster family homes, with the exception of children in 
relative foster family homes while the State is in the process of 
licensing the home. We also propose to prohibit the reimbursement of 
administrative costs claimed on behalf of children in unallowable 
facilities, with the exception of the month prior to a child's 
transition into an allowable facility.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            01/31/05                     70 FR 4803
Final Action                    11/00/05

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: State

Agency Contact: Kathleen McHugh, Divison Director, Children's Bureau 
Policy, Department of Health and Human Services, Administration for 
Children and Families, Room 2411, 330 C Street SW., Washington, DC 
20447
Phone: 202 401-5789
Fax: 202 205-8221
Email: [email protected]

RIN: 0970-AC14
_______________________________________________________________________




1231. HEAD START TRANSPORTATION

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

Legal Authority: 42 USC 9801 et seq

CFR Citation: 45 CFR 1310

Legal Deadline: None

Abstract: This final rule will extend for 150 days those parts of the 
Head Start transportation regulation that deal with the requirement 
that each vehicle used to transport children is equipped for use of 
child safety restraint systems and the requirement that each bus have a 
bus monitor. Additionally, these rules will provide Head Start grantees 
the opportunity to request further extension of the effective date when 
such an extension is in the best interest of the children they serve.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              01/16/04                     69 FR 2513
Final Action                    01/00/06

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Windy Hill, Associate Commissioner, Head Start Bureau, 
Department of Health and Human Services, 330 C Street SW., Washington, 
DC 20447
Phone: 202 205-8573
Email: [email protected]

RIN: 0970-AC16
_______________________________________________________________________




1232. 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                    12/00/05

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: Local, State

Agency Contact: Karen Tvedt, Policy Director, Child Care Bureau, 
Department of Health and Human Services, Administration for Children 
and Families, 330 C Street SW., Room 2046, Washington, DC 20447
Phone: 202 401-5130
Email: [email protected]

RIN: 0970-AC18
_______________________________________________________________________




1233. REASONABLE QUANTITATIVE STANDARD FOR REVIEW AND ADJUSTMENT OF 
CHILD SUPPORT ORDERS

Priority: Other Significant

Legal Authority: 42 USC 1302

CFR Citation: 45 CFR 303

Legal Deadline: None

Abstract: This interim final rule permits States to use reasonable 
quantitative standards in adjusting an existing child support award 
amount after conducting review of the order, regardless of the method 
review.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              12/28/04                    69 FR 77659
Final Action                    12/00/05

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

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-AC19
[FR Doc. 05-21044 Filed 10-28-05; 8:45 am]
BILLING CODE 4150-24-S