[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

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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, Chs. II, III, and XIII

Unified Agenda of Federal Regulatory and Deregulatory Actions

AGENCY:  Office of the Secretary, HHS.

ACTION:  Semiannual regulatory agenda.

_______________________________________________________________________

SUMMARY:  The regulatory agenda set out below provides information to 
the public about regulatory actions under development within the 
Department of Health and Human Services (HHS). The Agenda provides an 
opportunity for all concerned about the potential impact of these 
actions to participate in their development at an early stage. 
Semiannual publication of the Agenda is required under provisions of 
the Regulatory Flexibility Act of 1980 and of Executive Order 12866.

FOR FURTHER INFORMATION CONTACT:  Ann Stallion, U.S. Department of 
Health and Human Services, Washington, DC 20201, (202) 690-6824.

SUPPLEMENTARY INFORMATION:  The Office of Management and Budget 
requires that fall editions of the Agenda be augmented by a regulatory 
plan. The Plan is made up of a statement of the Department's regulatory 
priorities; this statement sets out the principles that Secretary 
Thompson has determined will govern the regulation-development process 
within HHS, and the overarching policy themes which will establish HHS 
regulatory priorities during fiscal year 2002. There follows amplified 
descriptions of those discrete regulatory actions under development 
which will best reflect these principles and policy themes.

     As noted above, public commentary is solicited on the Plan as 
a whole or on specific actions described in either the Plan or the 
full Agenda. Interested persons should direct specific comments to 
the contact official cited at the end of the descriptions of 
specific regulatory actions. Comments of a more generic nature, or 
comments on subjects which cross-cut the responsibilities of 
specific HHS agencies, should be sent to: Ann C. Agnew, Executive 
Secretary to the Department, Room 603H, 200 Independence Avenue 
SW., Washington, DC 20201.

     For this edition of HHS' regulatory agenda, the most important 
significant regulatory actions are included in The Regulatory Plan, 
which appears in part II of this issue of the Federal Register. The 
Regulatory Plan entries are listed in the table of contents below 
and are denoted by a bracketed bold reference, which directs the 
reader to the appropriate sequence number in part II.

Dated:  October 5, 2001.

 Ann C. Agnew,

Executive Secretary to the Department.

                                  Office of the Secretary--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
984          Governmentwide Debarment and Suspension (Nonprocurement) and Governmentwide             0991-AB12
            Requirements for Drug-Free Workplace (Grants).......................................
985          Modifications to Standards for Privacy of Individually Identifiable Health              0991-AB14
            Information (Reg Plan Seq No. 25).................................................
986          Implementing the Bioterrorism Prevention and Response Act of 2001 (Reg Plan Seq No.     0991-AB15
            26)...............................................................................
----------------------------------------------------------------------------------------------------------------
References in boldface appear in the Regulatory Plan in part II of this issue of the Federal Register


                                    Office of the Secretary--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
987          Shared Risk Exception to the Safe Harbor Provisions................................     0991-AA91
988          Civil Money Penalty Safe Harbor To Protect Payment of Medicare and Medigap Premiums     0991-AB04
            for ESRD Beneficiaries..............................................................
989          Safe Harbor for Ambulance Restocking...............................................     0991-AB05
990          Revisions and Technical Corrections to 42 CFR Chapter V............................     0991-AB09
991          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.........................................................................
----------------------------------------------------------------------------------------------------------------


                                   Office of the Secretary--Long-Term Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
992          Civil Money Penalties for Medicare+Choice Organizations and Medicaid Managed Care       0991-AB03
            Organizations.......................................................................
993          Safe Harbor for Arrangements Involving Federally Qualified Health Centers..........     0991-AB06
----------------------------------------------------------------------------------------------------------------


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                                   Office of the Secretary--Completed Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
994          Reproduction and Sale of Official Forms and Publications...........................     0991-AA83
995          Standards for Privacy of Individually Indentifiable Health Information.............     0991-AB08
996          Definition of Terms; Substantially in Excess and Usual Charges and Clarification of     0991-AB13
            the Good Cause Exception............................................................
----------------------------------------------------------------------------------------------------------------


                 Substance Abuse and Mental Health Services Administration--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
997          Community Mental Health Services Block Grant.......................................     0930-AA08
----------------------------------------------------------------------------------------------------------------


                   Substance Abuse and Mental Health Services Administration--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
998          Substance Abuse and Mental Health Services Administration Mental Health and             0930-AA09
            Substance Abuse Emergency Response Criteria.........................................
999          Seclusion and Restraint for Non-Medical Residential Facilities.....................     0930-AA10
----------------------------------------------------------------------------------------------------------------


                  Substance Abuse and Mental Health Services Administration--Completed Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
1000         Substance Abuse Prevention and Treatment Block Grant Applications Due Date Change       0930-AA04
            from March 31 to October 1 for FY 2001 and Beyond...................................
1001         Mandatory Guidelines for Federal Workplace Drug Testing Programs...................     0930-AA07
----------------------------------------------------------------------------------------------------------------


                         Centers for Disease Control and Prevention--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
1002         Control of Communicable Diseases (Reg Plan Seq No. 27)...........................     0920-AA03
1003         Amendments to Quality Assurance and Administrative Provision for Approval of            0920-AA04
            Respiratory Protective Devices......................................................
1004         Methods for Estimating Radiation Dose and Guidelines for Assessing Probability of       0920-AA05
            Cancer for Energy Employees Occupational Illness Compensation Program...............
----------------------------------------------------------------------------------------------------------------
References in boldface appear in the Regulatory Plan in part II of this issue of the Federal Register


                          Centers for Disease Control and Prevention--Long-Term Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
1005         Packaging and Handling of Infectious Substances and Select Agents..................     0920-AA02
----------------------------------------------------------------------------------------------------------------


                                  Departmental Management--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
1006         Implementation of the Equal Access to Justice Act in Agency Proceedings............     0990-AA02

[[Page 61558]]

 
1007         Administrative Wage Garnishment....................................................     0990-AA05
----------------------------------------------------------------------------------------------------------------


                                   Food and Drug Administration--Prerule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
1008         Natural Rubber-Containing Drugs; User Labeling.....................................     0910-AB56
1009         Requirements for Submission of In Vivo Bioequivalence Data.........................     0910-AC23
1010         Requirements for Medical Gas Containers and Closure Systems........................     0910-AC24
----------------------------------------------------------------------------------------------------------------


                                Food and Drug Administration--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
1011         Over-the-Counter (OTC) Drug Review.................................................     0910-AA01
1012         Establishment Registration and Product Listing for Drugs and Biologics.............     0910-AA49
1013         Investigational New Drugs: Export Requirements for Unapproved New Drug Products....     0910-AA61
1014         Safety Reporting and Recordkeeping Requirements for Marketed OTC Drugs.............     0910-AA86
1015         Safety Reporting Requirements for Human Drug and Biological Products (Reg Plan Seq      0910-AA97
            No. 28)...........................................................................
1016         Radioactive Drugs for Basic Research...............................................     0910-AB00
1017         Administrative Practices and Procedures; Advisory Opinions and Guidelines..........     0910-AB14
1018         Blood Initiative...................................................................     0910-AB26
1019         Applications for FDA Approval to Market a New Drug; Complete Response Letter;           0910-AB34
            Amendments to Unapproved Applications...............................................
1020         Expanded Access to Investigational Therapies.......................................     0910-AB37
1021         Electronic Submission of Postmarketing Safety Reports..............................     0910-AB42
1022         Distinguishing Marks for Drug Products Containing Insulin..........................     0910-AB43
1023         Pregnancy Labeling.................................................................     0910-AB44
1024         Positron Emission Tomography Drugs; Current Good Manufacturing Practice............     0910-AB63
1025         Current Good Manufacturing Practice for Medicated Feeds............................     0910-AB70
1026         Fixed-Combination Prescription and Over-the-Counter Drugs for Human Use............     0910-AB79
1027         Repackaging Approval Requirements..................................................     0910-AB81
1028         Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Dietary       0910-AB88
            Ingredients and Dietary Supplements (Reg Plan Seq No. 29).........................
1029         Submission in Electronic Format of Certain Labeling Information....................     0910-AB91
1030         Fees Relating to Drugs; Waiver and Reduction of Fees...............................     0910-AB92
1031         Periodic Testing for Certain Human Drug, Veterinary Drug, and Biological Product        0910-AB93
            Final Specifications................................................................
1032         Requirements Pertaining to Sampling Services and Private Laboratories Used in           0910-AB96
            Connection with Imported Food.......................................................
1033         Medical Devices, Medical Device Establishment Registration and Listing                  0910-AB99
            Requirements; Amendment.............................................................
1034         Reporting Information Regarding Falsification of Data..............................     0910-AC02
1035         Status Reports of Distribution and Use Information for Antimicrobial Animal Drug        0910-AC04
            Products Used in Food-Producing Animals.............................................
1036         Labeling Dietary Supplements for Women Who Are or May Become Pregnant..............     0910-AC09
1037         Regulation of Carcinogenic Compounds Used in Food-Producing Animals; Definition of      0910-AC13
            ``No Residue''......................................................................
1038         Control of Salmonella Enteritidis in Shell Eggs During Production and Retail (Reg       0910-AC14
            Plan Seq No. 30)..................................................................
1039         Aluminum in Large and Small Volume Parenterals Used in Total Parenteral Nutrition..     0910-AC18
1040         Use of Materials Derived from Ruminant Animals in FDA Regulated Products...........     0910-AC19
1041         Postmarketing Reports of Substandard or Ineffective Bulk Ingredients and Bulk           0910-AC20
            Ingredients from Unapproved Sources.................................................
1042         Exception from General Requirements for Informed Consent; Request for Comments and      0910-AC25
            Information (Reg Plan Seq No. 31).................................................
1043         Bar Code Label Requirements for Human Drug Products (Reg Plan Seq No. 32)........     0910-AC26
1044         Promotion and Charging For Investigational Drugs...................................     0910-AC27
----------------------------------------------------------------------------------------------------------------
References in boldface appear in the Regulatory Plan in part II of this issue of the Federal Register


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                                 Food and Drug Administration--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
1045         New Animal Drug Approval Process; Implementation of Title I of the Generic Animal       0910-AA02
            Drug and Patent Term Restoration Act (GADPTRA)......................................
1046         Current Good Manufacturing Practice; Amendment of Certain Requirements for Finished     0910-AA45
            Pharmaceuticals.....................................................................
1047         Bioavailability and Bioequivalence Requirements....................................     0910-AA51
1048         Determination That Informed Consent Is Infeasible or Is Contrary to the Best            0910-AA89
            Interest of Recipients..............................................................
1049         Labeling for Human Prescription Drugs; Revised Format (Reg Plan Seq No. 33)......     0910-AA94
1050         Current Good Manufacturing Practice; Revision of Certain Labeling Controls.........     0910-AA98
1051         Use of Ozone-Depleting Substances..................................................     0910-AA99
1052         Exports; Notification and Recordkeeping Requirements...............................     0910-AB16
1053         Foreign Establishment Registration and Listing (Reg Plan Seq No. 34).............     0910-AB21
1054         FDA Export Reform and Enhancement Act of 1996; Reporting and Recordkeeping              0910-AB24
            Requirements for Unapproved or Violative Products Imported for Further Processing or
            Incorporation and Later Export......................................................
1055         Antibiotic Drug Approval and Exclusivity...........................................     0910-AB33
1056         Amendment of Regulations Regarding Certain Label Statements on Prescription Drugs..     0910-AB39
1057         Supplements and Other Changes to Approved New Animal Drug Applications.............     0910-AB49
1058         Revisions to the General Safety Requirements for Biological Products; Direct Final      0910-AB51
            Rule................................................................................
1059         Discontinuation of a Lifesaving Product............................................     0910-AB60
1060         Supplements and Other Changes to an Approved Application...........................     0910-AB61
1061         Food Labeling: Trans Fatty Acids in Nutrition Labeling, Nutrient Content Claims,        0910-AB66
            and Health Claims (Reg Plan Seq No. 35)...........................................
1062         Presubmission Conferences..........................................................     0910-AB68
1063         Surgeon's and Patient Examination Gloves; Reclassification.........................     0910-AB74
1064         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 (Lookback) (Reg Plan Seq No. 36)..............................................
1065         Antibiotic Resistance Labeling.....................................................     0910-AB78
1066         180-Day Generic Drug Exclusivity for Abbreviated New Drug Applications.............     0910-AB80
1067         Food Additives: Food Contact Substances Notification System........................     0910-AB94
1068         Marking Requirements for and Prohibitions on the Reimportation of Imported Food         0910-AB95
            Products That Have Been Refused Admission into the United States (Reg Plan Seq No.
            37)...............................................................................
1069         State Certification of Mammography Facilities......................................     0910-AB98
1070         Availability for Public Disclosure and Submission to FDA for Public Disclosure of       0910-AC00
            Certain Data and Information Related to Gene Therapy or Xenotransplantation.........
1071         Examination of Administrative Record and Other Advisory Committee Records..........     0910-AC03
1072         Efficacy Evidence Needed for Products to be Used Against Toxic Substances When          0910-AC05
            Human Studies Are Unethical (Reg Plan Seq No. 38).................................
1073         Additional Safeguards for Children in Clinical Investigations of FDA Regulated          0910-AC07
            Products............................................................................
1074         Implementing Court Decisions, ANDA Approvals, and 180-Day Exclusivity..............     0910-AC11
1075         Revocation of Conditions for Marketing Digoxin Products for Oral Use...............     0910-AC12
1076         Additional Criteria and Procedures for Classifying Over-the-Counter Drugs as            0910-AC22
            Generally Recognized as Safe and Effective and Not Misbranded (Reg Plan Seq No.
            39)...............................................................................
----------------------------------------------------------------------------------------------------------------
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                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
1077         Infant Formula: Requirements Pertaining to Good Manufacturing Practice, Quality         0910-AA04
            Control Procedures, Quality Factors, Notification Requirements, and Records and
            Reports.............................................................................
1078         Food Labeling Review...............................................................     0910-AA19
1079         Medical Foods......................................................................     0910-AA20
1080         Direct-to-Consumer Promotion Regulations...........................................     0910-AA90
1081         Investigational Use New Animal Drug Regulations (Section 610 Review).............     0910-AB02
1082         Suitability Determination for Donors of Human Cellular and Tissue-Based Products...     0910-AB27
1083         Current Good Tissue Practice for Manufacturers of Human Cellular and Tissue-Based       0910-AB28
            Products............................................................................
1084         Requirements for Liquid Medicated Feed and Free-Choice Medicated Feed..............     0910-AB50
1085         Bulk Drug Substances for Use in Pharmacy Compounding...............................     0910-AB57
1086         Pharmacy and Physician Compounding of Drug Products................................     0910-AB58

[[Page 61560]]

 
1087         Drug Products That Present Demonstrable Difficulties for Compounding Because of         0910-AB59
            Reasons of Safety or Effectiveness..................................................
1088         Implementation of the Import Tolerance Provisions of the Animal Drug Availability       0910-AB71
            Act of 1996.........................................................................
1089         Mandatory HACCP Regulations for Manufacturers of Rendered Products.................     0910-AB72
1090         Citizen Petitions; Actions That Can Be Requested by Petition; Denials, Withdrawals,     0910-AB73
            and Referrals for Other Administrative Action.......................................
1091         Stability Testing of Drugs.........................................................     0910-AB82
1092         Substances Prohibited From Use in Animal Food or Feed..............................     0910-AB90
1093         Addition to the List of Drug Products That Have Been Withdrawn From the Market for      0910-AC01
            Reasons of Safety or Effectiveness..................................................
1094         Addition to the List of Drug Products That Have Been Withdrawn or Removed From the      0910-AC08
            Market for Reasons of Safety or Effectiveness.......................................
1095         Overwrap for Inhalation Products Packaged in Low Density Polyethylene (LDPE)            0910-AC10
            Containers..........................................................................
1096         Premarket Notice Concerning Bioengineered Foods....................................     0910-AC15
1097         Rescission of Substantially Equivalent Decisions and Rescission Appeal Procedures..     0910-AC16
1098         Institutional Review Boards: Registration Requirements.............................     0910-AC17
1099         Chronic Wasting Disease: Control of Food Products and Cosmetics Derived from            0910-AC21
            Exposed Animal Populations..........................................................
----------------------------------------------------------------------------------------------------------------


                                 Food and Drug Administration--Completed Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
1100         Hearing Aids; Professional and Patient Labeling; Conditions for Sale...............     0910-AA39
1101         Classification of Computer Software Programs That Are Medical Devices..............     0910-AA41
1102         Reinventing FDA Food Regulations...................................................     0910-AA58
1103         Part 600-Biological Products: General (Completion of a Section 610 Review).......     0910-AC06
----------------------------------------------------------------------------------------------------------------


                        Health Resources and Services Administration--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
1104         National Practitioner Data Bank for Adverse Information on Physicians and Other         0906-AA41
            Health Care Practitioners: Medical Malpractice Payments Reporting Requirements......
1105         Designation of Medically Underserved Populations and Health Professional Shortage       0906-AA44
            Areas...............................................................................
1106         National Vaccine Injury Compensation Program: Revisions and Additions to the            0906-AA55
            Vaccine Injury Table................................................................
1107         National Practitioner Data Bank for Adverse Information on Physicians and Other         0906-AA57
            Health Care Practitioners: Reporting Adverse and Negative Actions...................
----------------------------------------------------------------------------------------------------------------


                         Health Resources and Services Administration--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
1108         National Vaccine Injury Compensation Program: Revisions and Additions to the            0906-AA58
            Vaccine Injury Table................................................................
1109         Adoption of the Interim Final Rule as a Final Rule with Amendments for Ricky Ray        0906-AA59
            Hemophilia..........................................................................
----------------------------------------------------------------------------------------------------------------


                         Health Resources and Services Administration--Completed Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
1110         Compliance Alternatives for Provision of Uncompensated Services....................     0906-AA52

[[Page 61561]]

 
1111         Final Rule for the Health Professions, Nursing, Public Health, and Allied Health        0906-AA53
            Training Grant Programs Under 42 CFR Parts 57 and 58................................
----------------------------------------------------------------------------------------------------------------


                                   Indian Health Service--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
1112         Tribal Self-Governance Amendments (Reg Plan Seq No. 40)..........................     0917-AA05
----------------------------------------------------------------------------------------------------------------
References in boldface appear in the Regulatory Plan in part II of this issue of the Federal Register


                                     Indian Health Service--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
1113         Indian Child Protection and Family Violence Prevention Act Minimum Standards of         0917-AA02
            Character...........................................................................
----------------------------------------------------------------------------------------------------------------


                               National Institutes of Health--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
1114         National Institutes of Health AIDS Research Loan Repayment Program.................     0925-AA02
1115         Undergraduate Scholarship Program Regarding Professions Needed by the NIH..........     0925-AA10
1116         National Cancer Institute Clinical Cancer Education Program........................     0925-AA17
1117         National Institutes of Health Loan Repayment Program for Research..................     0925-AA18
1118         NIH Center Grants..................................................................     0925-AA24
1119         National Institutes of Health Clinics Research Loan Repayment Program for               0925-AA25
            Individuals from Disadvantaged Backgrounds..........................................
1120         NIH Loan Repayment Program for Minority Health Disparties Research.................     0925-AA26
1121         Pediatric Research Loan Repayment Program..........................................     0925-AA27
1122         NIH Training Grants................................................................     0925-AA28
1123         National Institutes of Health Loan Repayment Program for Clinical Researchers......     0925-AA30
1124         Standards for a National Chimpanzee Sanctuary System...............................     0925-AA31
----------------------------------------------------------------------------------------------------------------


                                 National Institutes of Health--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
1125         National Institute of Child Health and Human Development Contraception and              0925-AA19
            Infertility Research Loan Repayment Program.........................................
1126         Scientific Peer Review of Research Grant Applications and Research and Development      0925-AA20
            Contract Projects...................................................................
----------------------------------------------------------------------------------------------------------------


                                National Institutes of Health--Completed Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
1127         National Research Service Awards...................................................     0925-AA16
----------------------------------------------------------------------------------------------------------------


[[Page 61562]]


                            Office of Public Health and Science--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
1128         Public Health Services Policies on Research Misconduct.............................     0940-AA04
----------------------------------------------------------------------------------------------------------------


                              Office of Public Health and Science--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
1129         Public Health Service Standards for the Protection of Research Misconduct               0940-AA01
            Whistleblowers......................................................................
1130         Federal Policy (Common Rule) for the Protection of Human Subjects..................     0940-AA03
1131         Protection of Human Research Subjects..............................................     0940-AA05
----------------------------------------------------------------------------------------------------------------


                          Centers for Medicare & Medicaid Services--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
1132         Medicare and Medicaid Programs; Terms, Definitions, and Addresses: Technical            0938-AH53
            Amendments (CMS-9877-P).............................................................
1133         National Standard for Identifiers of Health Plans (CMS-4145-P) (Reg Plan Seq No.        0938-AH87
            41)...............................................................................
1134         End Stage Renal Disease Bad Debt Payment (CMS-1126-P)..............................     0938-AK02
1135         Fire Safety Requirements for RNHCI, ASC, Hospices, PACE, Hospitals, and Long-Term       0938-AK35
            Care Facilities and ICFs for the Mentally Retarded (CMS-3047-P).....................
1136         Medical Devices Coverage Decisions Related to Health Care Technology (CMS-3059-P)..     0938-AK43
1137         Medicare Program; Reporting and Repayment of Overpayments (CMS-6011-P).............     0938-AK45
1138         Health Insurance Reform: Standards for Electronic Claims Attachments (CMS-0050-P)       0938-AK62
            (Reg Plan Seq No. 42).............................................................
1139         Health Insurance Reform: Modifications to Standards for Electronic Transactions         0938-AK64
            (CMS-0003-P) (Reg Plan Seq No. 43)................................................
1140         Prospective Payment System for Long-Term Care Hospitals for FY 2003 (CMS-1177-P)        0938-AK69
            (Reg Plan Seq No. 44).............................................................
1141         Modifications to Medicare Managed Care Rules Based on Provisions of BIPA and            0938-AK71
            Technical Corrections (CMS-1180-P) (Reg Plan Seq No. 45)..........................
1142         Revisions to Transaction and Code Set Standards for Electronic Transactions (CMS-       0938-AK76
            0005-P) (Reg Plan Seq No. 46).....................................................
1143         Organ Procurement Organization Condition for Coverage (CMS-3064-IFC) (Reg Plan Seq      0938-AK81
            No. 47)...........................................................................
1144         Qualification Requirements for Directors of Laboratories Performing High Complexity     0938-AK83
            Testing (CMS-2094-P)................................................................
1145         State Allotments for Payment of Medicare Part B Premiums for Qualified Individuals;     0938-AK91
            Federal Fiscal Year 2002 (CMS-2087-PN)..............................................
1146         Home Health Prospective Payment System Refinements (CMS-1161-P) (Reg Plan Seq No.       0938-AK93
            48)...............................................................................
1147         Medicaid Managed Care (CMS-2104-F) (Reg Plan Seq No. 49).........................     0938-AK96
1148         Medicaid Upper Payment Limit for Non-State Government-Owned or Operated Hospitals       0938-AL05
            (CMS-2134-P) (Reg Plan Seq No. 50)................................................
1149         Home Health Prospective Payment System Rate Update For FY 2003 (CMS-1198-NC) (Reg       0938-AL16
            Plan Seq No. 51)..................................................................
1150         Requirements for Paid Feeding Assistants in Long-Term Care Facilities (CMS-2131-P)      0938-AL18
            (Reg Plan Seq No. 52).............................................................
1151         Hospital Outpatient Prospective Payment System for Calendar Year 2003 (CMS-1206-P)      0938-AL19
            (Reg Plan Seq No. 53).............................................................
1152         Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities-     0938-AL20
            Update for FY 2003 (CMS-1202-P) (Reg Plan Seq No. 54).............................
1153         Revisions to Payment Policies Under the Physician Fee Schedule for Calendar Year        0938-AL21
            2003 (CMS-1204-P) (Reg Plan Seq No. 55)...........................................
1154         Hospital Inpatient Rehabilitation Prospective Payment System for FY 2003 (CMS-1205-     0938-AL22
            P) (Reg Plan Seq No. 56)..........................................................
1155         Hospital Inpatient Prospective Payment System for FY 2003 (CMS-1203-P) (Reg Plan        0938-AL23
            Seq No. 57).......................................................................
1156         Initiative to Endorse Prescription Drug Discount Programs (CMS-4027-P) (Reg Plan        0938-AL28
            Seq No. 58).......................................................................
----------------------------------------------------------------------------------------------------------------
References in boldface appear in the Regulatory Plan in part II of this issue of the Federal Register


[[Page 61563]]


                           Centers for Medicare & Medicaid Services--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
1157         Health Insurance Reform: Standard Unique Health Care Provider Identifier (CMS-0045-     0938-AH99
            F) (Reg Plan Seq No. 59)..........................................................
1158         Security Standards (CMS-0049-F) (Reg Plan Seq No. 60)............................     0938-AI57
1159         National Standard Employer Identifier (CMS-0047-F) (Reg Plan Seq No. 61).........     0938-AI59
1160         Medicare Program; Coverage and Administrative Policies for Clinical Diagnostic          0938-AI92
            Laboratory Tests (CMS-3250-F).......................................................
1161         Rural Health Clinics: Amendments to Participation Requirements and Payment              0938-AJ17
            Provisions, and Establishment of a Quality Assessment and Improvement Program (CMS-
            1910-F).............................................................................
1162         Fee Schedule for Payment of Ambulance Services and Revisions to the Physician's         0938-AK30
            Certification Requirements for Coverage of Nonemergency Ambulance Services (CMS-1002-
            FC) (Reg Plan Seq No. 62).........................................................
1163         Hospital Conditions of Participation: Quality Assessment and Performance                0938-AK40
            Improvements (CMS-3050-F)...........................................................
1164         Payment for Upgraded Durable Medical Equipment (CMS-1084-P)........................     0938-AK50
1165         Prospective Payment System for Hospital Outpatient Services: Criteria for               0938-AK59
            Establishing New Pass-Through Categories for Medical Devices (CMS-1179-IFC).........
1166         Modifications to Managed Care Rules Based on Payment Provisions in BIPA and             0938-AK90
            Technical Corrections (CMS-1181-F)..................................................
----------------------------------------------------------------------------------------------------------------
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                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
1167         ''Without Fault'' and Beneficiary Waiver of Recovery As It Applies to Medicare          0938-AD95
            Overpayment Liability (CMS-6007-F)..................................................
1168         Revision of Medicare/Medicaid Hospital Conditions of Participation (CMS-3745-F)....     0938-AG79
1169         Home Health Agency (HHA) Conditions of Participation (HCMS-3819-FC)................     0938-AG81
1170         End Stage Renal Disease (ESRD) Conditions for Coverage (CMS-3818-P) (Section 610        0938-AG82
            Review)...........................................................................
1171         Criteria for Approval of Facilities to Perform Covered Heart, Liver, Lung, Pancreas     0938-AH17
            and Intestinal Transplants (CMS-3835-P).............................................
1172         Hospice Care-Conditions of Participation (CMS-3844-P)..............................     0938-AH27
1173         Requirements for Establishing and Maintaining Medicare Billing Privileges (CMS-6002-    0938-AH73
            P)..................................................................................
1174         Update of Ratesetting Methodology, Payment Rates and the List of Covered Surgical       0938-AH81
            Procedures for Ambulatory Surgical Centers (CMS-1885-FC)............................
1175         Medical Child Support and Health Insurance Coverage of Dependent Children (CMS-2081-    0938-AI21
            P)..................................................................................
1176         Surety Bond Requirements for Comprehensive Outpatient Rehabilitation Facilities,        0938-AI48
            Rehabilitation Agencies (CMS-6005-P)................................................
1177         Appeals of Carrier Determination That a Supplier Fails To Meet the Requirements for     0938-AI49
            Medicare Billing Privileges (CMS-6003-F)............................................
1178         Advance Refunding of Debt and Methodology for Repayment of Loan (CMS-1777-P).......     0938-AI75
1179         Medicare Coverage of, and Payment for, Bone Mass Measurements (CMS-3004-F).........     0938-AI89
1180         Coverage of Religious Non-Medical Health Care Institutions (CMS-1909-F)............     0938-AI93
1181         External Quality Review of Medicaid Managed Care Organizations (CMS-2015-F)........     0938-AJ06
1182         Reporting Outcome and Assessment Information Set (OASIS) Data as Part of the            0938-AJ10
            Conditions of Participation for Home Health Agencies (CMS-3006-F)...................
1183         Hospital Conditions of Participation: Laboratory Services (CMS-3014-F).............     0938-AJ29
1184         Medicare Hospice Care Amendments (CMS-1022-P)......................................     0938-AJ36
1185         Emergency Medical Treatment and Labor Act (EMTALA) (CMS-1063-P)....................     0938-AJ39
1186         Protection for Women Who Elect Reconstruction After a Mastectomy (CMS-2040-IFC)....     0938-AJ44
1187         Surety Bonds Requirements for Suppliers of Durable Medical Equipment (CMS-6006-P)..     0938-AJ64
1188         Surety Bond Requirements for Home Health Agencies (HHAS) (CMS-6001-P)..............     0938-AJ81
1189         Use of Restraint and Seclusion in Residential Treatment Facilities Providing            0938-AJ96
            Inpatient Psychiatric Services to Individuals Under Age 21 (CMS-2065-F).............
1190         Application of Inherent Reasonableness to All Medicare Part B Services (Other than      0938-AJ97
            Physician Services) (CMS-1908-F)....................................................
1191         Supplier Standards for Home Oxygen, Therapeutic Shoes, Home Nutrition Therapy, and      0938-AJ98
            Consignment Closets (CMS-6010-P)....................................................
1192         Non-Federal Governmental Plans Exempt From Health Insurance Portability                 0938-AK00
            Requirements (CMS-2033-IFC).........................................................
1193         Payment for Clinical Psychology Training Programs (CMS-1089-F).....................     0938-AK15
1194         Conditions of Participation of Intermediate Care Facilities for Persons With Mental     0938-AK23
            Retardation (CMS-3046-P)............................................................

[[Page 61564]]

 
1195         Clinical Lab Requirements-Revisions to Regulations Implementing CLIA (CMS-2226-F)..     0938-AK24
1196         Medicare Provider and Supplier Hearing Procedures (CMS-2093-P).....................     0938-AK39
1197         Supplementary Medical Insurance Premium Surcharge Agreements (CMS-4007-P)..........     0938-AK42
1198         Improvements to the Medicare+Choice Appeals and Grievance Procedures (CMS-4024-F)..     0938-AK48
1199         Recognition of the American Osteopathic Association for Ambulatory Surgical Center      0938-AK53
            Programs (CMS-2079-FN)..............................................................
1200         Challenges to National Coverage Determinations and Local Coverage Determinations        0938-AK60
            (CMS-3063-P)........................................................................
1201         Revised Process for Making Medicare Coverage Decisions (CMS-3062-N)................     0938-AK61
1202         Health Insurance Reform: Standards for Electronic Signatures (CMS-0051-F)..........     0938-AK63
1203         Physicians' Referrals to Health Care Entities With Which They Have Financial            0938-AK67
            Relationships-Phase II (CMS-1810-FC)................................................
1204         Rate of Reimbursement of Photocopy Expenses for Prospective Payment System              0938-AK68
            Providers (CMS-3055-P)..............................................................
1205         Medicare Inpatient Disproportionate Share Hospital Adjustment Calculation (CMS-1171-    0938-AK77
            IFC)................................................................................
1206         Statement of Intent (CMS-1185-P)...................................................     0938-AK79
1207         Hospital Reference Laboratory and Medicare Secondary Payer (CMS-1187-P)............     0938-AK87
1208         Portability in the Group Health Insurance Market--Shared HHS Provisions (CMS-2048-      0938-AK88
            F)..................................................................................
1209         Extended Medicaid for Certain Families Who Lose Medicaid Eligibility Because of         0938-AK92
            Earned Income and the Residency of Minor Parents and Pregnancy (CMS 2026-F).........
1210         Extending Medicare Entitlement When Disability Benefit Entitlement Ends Because of      0938-AK94
            Substantial Gainful Activity (CMS-4018-P)...........................................
1211         Relief from Medicare Part A Late Enrollment Penalty for Group Buy-In for State and      0938-AK99
            Local Retirees (CMS-4022-P).........................................................
1212         Modifications to the State Children's Health Insurance Program (CMS-2006-IFC)......     0938-AL00
1213         Continue to Allow States an Option Under the Medicaid Spousal Impoverishment            0938-AL06
            Provisions to Increase the Community Spouse's Income When Adjusting the Protected
            Resource Allowance (CMS-2128-P).....................................................
1214         Medicare Limits on the Valuation of a Depreciable Asset Recognized as an Allowance      0938-AL12
            for Depreciation and Interest on Capital Indebtedness After a change of Ownership
            (CMS-1004-F)........................................................................
1215         Update Interest Assessment on Medicare Overpayment and Underpayment (CMS-6014-P)...     0938-AL14
1216         Use of Restraint and Seclusion in Medicare and Medicaid Participating Facilities        0938-AL26
            that Provide Inpatient or Residential Care (CMS-2130-P).............................
1217         Payment for Respiratory Assist Devices with Bi-level Capability and a Back-up Rate      0938-AL27
            (CMS-1167-P)........................................................................
----------------------------------------------------------------------------------------------------------------


                           Centers for Medicare & Medicaid Services--Completed Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
1218         Medicaid Drugs Rebate Program (CMS-2046-FC)........................................     0938-AF42
1219         Liability for Third Parties To Pay for Services (CMS-2080-P).......................     0938-AH01
1220         Requirements for Enrollment of Medicaid Recipients Under Cost Effective Employer-       0938-AH48
            Based Group Health Plans (CMS-2047-FC)..............................................
1221         Revisions to Conditions for Coverage for Ambulatory Surgical Centers (CMS-3887-P)..     0938-AH83
1222         Medicare Program: Prospective Payment System for Inpatient Rehabilitation Hospital      0938-AJ55
            Services (CMS-1069-F)...............................................................
1223         State Health Insurance Assistance Program (SHIP) (CMS-4005-IFC)....................     0938-AJ67
1224         Practice Expense Data Collection (CMS-1111-IFC)....................................     0938-AK14
1225         Provisions of the Balanced Budget and Refinement Act of 1999; Hospital Inpatient        0938-AK20
            Payments and Rates and Costs of Graduate Medical Education (CMS-1131-F).............
1226         Requirements for the Recredentialing of Medicare+Choice Organization Providers (CMS-    0938-AK41
            1160-F).............................................................................
1227         Medicaid Management Information System Revised Definition of ``Mechanized Claims        0938-AK44
            Processing and Information Retrieval System'' (CMS-2123-IFC)........................
1228         Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities-     0938-AK47
            Update (CMS-1163-F).................................................................
1229         Civil Money Penalties, Assessments, and Revised Sanction Authorities (CMS-6145-FC).     0938-AK49
1230         Update to the Prospective Payment System for Home Health Agencies for FY 2002 (CMS-     0938-AK51
            1147-NC)............................................................................
1231         Prospective Payment System for Hospital Outpatient Services for Calendar Year 2002      0938-AK54
            (CMS-1159-F)........................................................................
1232         Medicare as Secondary Payer-Recovery of Conditional Payments (CMS-6009-P)..........     0938-AK55
1233         Five Year Review of Work Relative Value Units Under the Physician Fee Schedule          0938-AK56
            Proposed Notice (CMS-1170-PN).......................................................
1234         Revisions to Payment Policies Under the Physician Fee Schedule for Calendar Year        0938-AK57
            2002 (CMS-1169-F)...................................................................
1235         Changes to National Coverage Determinations and Local Coverage Determinations (CMS-     0938-AK58
            4019-FC)............................................................................

[[Page 61565]]

 
1236         Replacement of Reasonable Charge Methodology by Fee Schedules for Parenteral and        0938-AK66
            Enteral Nutrients, Equipment, and Supplies (CMS-1010-F).............................
1237         Changes to the Hospital Inpatients Prospective Payment System for Fiscal Year 2002      0938-AK73
            Rates (CMS-1158-F)..................................................................
1238         Changes to Inpatient BIPA for Fiscal Year 2001 (CMS-1178-F)........................     0938-AK74
1239         Medicare+Choice ESRD Rates (CMS-1182-FN)...........................................     0938-AK75
1240         Procedures for Public Consultations for Coding and Payment Determinations for New       0938-AK80
            Laboratory Tests (CMS-1186-N).......................................................
1241         Recognition of the American Osteopathic Association for Critical Access Hospitals       0938-AK84
            (CMS-2099-N)........................................................................
1242         Protection and Promotion of Resident Rights (CMS-3065-P)...........................     0938-AK85
1243         Standards for Electronic Transactions-Elimination of NDC Coding Standards (CMS-0006-    0938-AK86
            P)..................................................................................
1244         Modification of the Medicaid Upper Payment Limit Transition Period for Inpatient,       0938-AK89
            Outpatient Hospitals, Nursing and Intermediate Care Facility Services for the
            Mentally Retarded (CMS-2100-P)......................................................
1245         Hospital Conditions of Participation: Anesthesia Services (CMS-3070-F).............     0938-AK95
1246         Medicare Program; Emergency Approval for Coverage of End-Stage Renal Disease            0938-AK98
            Facilities in the Houston, Texas Area (CMS-3074-F)..................................
1247         Medicare and Medicaid Programs; Change of Agency Name: Technical Amendments (CMS-       0938-AL02
            9010-FC)............................................................................
1248         Payments for New Medical Services and New Technologies Under the Acute Care             0938-AL09
            Hospital Inpatient Prospective Payment System (CMS-1176-F)..........................
----------------------------------------------------------------------------------------------------------------


                          Administration for Children and Families--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
1249         Program Performance Standards for the Operation of Head Start Programs.............     0970-AB99
1250         Safeguarding Child Support and Expanded FPLS Information...........................     0970-AC01
1251         Developmental Disabilities and Bill of Rights Act..................................     0970-AC07
----------------------------------------------------------------------------------------------------------------


                           Administration for Children and Families--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
1252         Construction and Major Renovation of Head Start and Early Head Start Facilities....     0970-AB54
1253         Child Support Enforcement for Indian Tribes........................................     0970-AB73
1254         Child Support Enforcement Program Omnibus Conforming Regulation....................     0970-AB81
1255         Family Child Care Program Option for Head Start Programs...........................     0970-AB90
1256         Technical Revision of Head Start Regulations To Make Them Conform to Recent             0970-AC00
            Statutory Revisions.................................................................
1257         High Performance Bonus Awards Under the TANF Program...............................     0970-AC06
----------------------------------------------------------------------------------------------------------------


                           Administration for Children and Families--Completed Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
1258         Individual Development Accounts....................................................     0970-AC08
----------------------------------------------------------------------------------------------------------------


                                  Administration on Aging--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
1259         Grants for State and Community Programs on Aging, Training, Research and                0985-AA00
            Discretionary Programs; Vulnerable Elder Rights; and Grants to Indians and Native
            Hawaiians...........................................................................
----------------------------------------------------------------------------------------------------------------


[[Page 61566]]


                                   Administration on Aging--Completed Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
1260         Grants for State and Community Programs on Aging, Family Caregivers, American           0985-AA01
            Indians, and Native Hawaiians.......................................................
----------------------------------------------------------------------------------------------------------------

_______________________________________________________________________


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


Office of the Secretary (OS)



_______________________________________________________________________




984. GOVERNMENTWIDE DEBARMENT AND SUSPENSION (NONPROCUREMENT) AND 
GOVERNMENTWIDE REQUIREMENTS FOR DRUG-FREE WORKPLACE (GRANTS)

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

Legal Authority: 5 USC 301; 41 USC 701 et seq, sec 2455; PL 103-355; 31 
USC 6101 note; EO 12689; EO 12549

CFR Citation: 45 CFR 76; 45 CFR 82

Legal Deadline: None

Abstract: This proposed common rule is revised to simplify and 
streamline nonprocurement debarment and suspension requirements, as 
well as correspond to procurement regulations where possible. The 
revision will separate the debarment and suspension and Drug-Free 
Workplace regulations, and will be written in the plain language 
format.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            02/00/02

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Diane Osterhus, Federal Assistance Policy Specialist, 
Department of Health and Human Services, Office of the Secretary, Room 
517D, Office of Grants and Acquisition Management, 200 Independence 
Avenue SW., Washington, DC 20201
Phone: 202 690-5729
Fax: 202 690-6901
Email: [email protected]

RIN: 0991-AB12
_______________________________________________________________________




985.  MODIFICATIONS TO STANDARDS FOR PRIVACY OF INDIVIDUALLY 
IDENTIFIABLE HEALTH INFORMATION

 Regulatory Plan: This entry is Seq. No. 25 in part II of this issue of 
the Federal Register.

RIN: 0991-AB14
_______________________________________________________________________




986.  IMPLEMENTING THE BIOTERRORISM PREVENTION AND RESPONSE ACT 
OF 2001

 Regulatory Plan: This entry is Seq. No. 26 in part II of this issue of 
the Federal Register.

RIN: 0991-AB15
_______________________________________________________________________


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 Rule                      03/00/02

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 (OCIG), 330 Independence Avenue SW., Washington, DC 20201
Phone: 202 619-0089

RIN: 0991-AA91
_______________________________________________________________________




988. CIVIL MONEY PENALTY SAFE HARBOR TO PROTECT PAYMENT OF MEDICARE AND 
MEDIGAP PREMIUMS FOR ESRD BENEFICIARIES

Priority: Substantive, Nonsignificant

Legal Authority: Social Security Act, sec 1128A(a)(5)

CFR Citation: 42 CFR 1003

Legal Deadline: None

Abstract: This final rule will set forth in the OIG's civil money 
penalty provisions in 42 CFR part 1003 a new safe harbor for unlawful 
inducements to beneficiaries to provide protection for independent 
dialysis facilities that pay, in whole or in part, premiums for 
Supplementary Medical Insurance (Medicare part B) or Medicare

[[Page 61567]]

Supplemental Health Insurance policies (Medigap) for financially needy 
Medicare beneficiaries with end-stage renal disease (ESRD). This safe 
harbor specifically establishes various standards that, if met, would 
result in the particular arrangement being protected from civil 
penalties under section 1128A(a)(5) of the Social Security Act.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            05/02/00                    65 FR 25460
NPRM Comment Period End         07/03/00
Final Action                    04/00/02

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 (OCIG), 330 Independence Avenue SW., Washington, DC 20201
Phone: 202 619-0089

RIN: 0991-AB04
_______________________________________________________________________




989. SAFE HARBOR FOR AMBULANCE RESTOCKING

Priority: Substantive, Nonsignificant

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

CFR Citation: 42 CFR 1001

Legal Deadline: None

Abstract: This rule will set forth acceptable restocking arrangements 
between municipal and nonprofit ambulance companies and hospitals.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            05/22/00                    65 FR 32060
NPRM Comment Period End         07/21/00
Final Action                    12/00/01

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 (OCIG), 330 Independence Avenue SW., Washington, DC 20201
Phone: 202 619-0089

RIN: 0991-AB05
_______________________________________________________________________




990. REVISIONS AND TECHNICAL CORRECTIONS TO 42 CFR CHAPTER V

Priority: Substantive, Nonsignificant

Legal Authority: 42 USC 1302; 42 USC 1320a-7; 42 USC 1320a-7a; 42 USC 
1320a-7b; 42 USC 1320a-7d(b); 42 USC 1395u

CFR Citation: 42 CFR 1001; 42 CFR 1003; 42 CFR 1008

Legal Deadline: None

Abstract: This final rule sets forth several miscellaneous revisions 
and technical corrections to the OIG regulations codified in 42 CFR 
chapter V. Among other revisions, this rule makes revisions or 
clarifications to the term ``item or service'' contained in part 1003 
of this chapter, to the reinstatement procedures relating to exclusions 
resulting from the default on health education or scholarship 
obligations set forth in part 1001, and to the statute of limitations 
for the OIG to impose an exclusion under part 1001.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            10/20/00                    65 FR 63035
NPRM Comment Period End         12/20/00
Final Action                    03/00/02

Regulatory Flexibility Analysis Required: No

Government Levels Affected: Undetermined

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

RIN: 0991-AB09
_______________________________________________________________________




991. 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

Legal Authority: PL 100-259, Civil Rights Restoration Act of 1987

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

Legal Deadline: None

Abstract: The Secretary proposes to amend the Department's regulations 
implementing title VI of the Civil Rights Act of 1964, as amended, 
section 504 of the Rehabilitation Act of 1973, as amended, title IX of 
the Education Amendments of 1972, and the Age Discrimination Act of 
1975, as amended. The principal proposed conforming change is to amend 
the regulations to add the definitions of ``program or activity'' or 
``program'' that correspond to the statutory definitions enacted under 
the Civil Rights Restoration Act of 1987.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            10/26/00                    65 FR 64194
NPRM Comment Period End         11/27/00
Final Action                    12/00/01
Final Action Effective          02/00/02

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Federal

Agency Contact: Robinsue Frohboese, Acting Director, Office for Civil 
Rights, Department of Health and Human Services, Office of the 
Secretary
Phone: 202 619-0403

RIN: 0991-AB10

[[Page 61568]]

_______________________________________________________________________


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


Office of the Secretary (OS)



_______________________________________________________________________




992. CIVIL MONEY PENALTIES FOR MEDICARE+CHOICE ORGANIZATIONS AND 
MEDICAID MANAGED CARE ORGANIZATIONS

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 reflect OIG's authority to impose 
civil money penalties against Medicare+Choice organizations that engage 
in certain abusive practices, including failure to provide medically 
necessary care and discriminatory enrollment procedures. This rule 
would specifically address the Medicare+Choice provisions set forth in 
Public Law 105-33, the Balanced Budget Act of 1997, and the Medicaid 
managed care provisions.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                             To Be                       Determined

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 (OCIG), 330 Independence Avenue SW., Washington, DC 20201
Phone: 202 619-0089

RIN: 0991-AB03
_______________________________________________________________________




993. SAFE HARBOR FOR ARRANGEMENTS INVOLVING FEDERALLY QUALIFIED HEALTH 
CENTERS

Priority: Substantive, Nonsignificant

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

CFR Citation: 42 CFR 1001

Legal Deadline: None

Abstract: This rule would set forth a new anti-kickback safe harbor 
addressing remuneration between Federal Qualified Health Centers and 
certain service providers where a significant community benefit exists.

Timetable: Next Action Undetermined

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 (OCIG), 330 Independence Avenue SW., Washington, DC 20201
Phone: 202 619-0089

RIN: 0991-AB06
_______________________________________________________________________


Department of Health and Human Services (HHS)         Completed Actions


Office of the Secretary (OS)



_______________________________________________________________________




994. REPRODUCTION AND SALE OF OFFICIAL FORMS AND PUBLICATIONS

Priority: Info./Admin./Other

CFR Citation: 45 CFR 101

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn                       08/31/01

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Michael Herrell
Phone: 202 690-5739

RIN: 0991-AA83
_______________________________________________________________________




995. STANDARDS FOR PRIVACY OF INDIVIDUALLY INDENTIFIABLE HEALTH 
INFORMATION

Priority: Economically Significant. Major under 5 USC 801.

CFR Citation: 45 CFR 160; 45 CFR 164

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Rule                      12/28/00                    65 FR 82462
60-Day Delay of Effective Date 
To 04/14/2001                   02/26/01                    66 FR 12434
Comment Period Extended         03/30/01                    66 FR 12738

Regulatory Flexibility Analysis Required: Yes

Government Levels Affected: State, Local, Tribal, Federal

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

Agency Contact: Roxanne Gibson
Phone: 202 260-5083

RIN: 0991-AB08
_______________________________________________________________________




996. DEFINITION OF TERMS; SUBSTANTIALLY IN EXCESS AND USUAL CHARGES AND 
CLARIFICATION OF THE GOOD CAUSE EXCEPTION

Priority: Substantive, Nonsignificant

CFR Citation: 42 CFR 1001

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn                       10/09/01

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

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

RIN: 0991-AB13

[[Page 61569]]

_______________________________________________________________________


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


Substance Abuse and Mental Health Services Administration (SAMHSA)



_______________________________________________________________________




997.  COMMUNITY MENTAL HEALTH SERVICES BLOCK GRANT

Priority: Economically Significant. Major under 5 USC 801.

Legal Authority: 42 USC 300x-1

CFR Citation: 42 CFR 96

Legal Deadline: None

Abstract: SAMHSA is responsible for the implementation of the Community 
Mental health Services (CMHS) Block Grant program which distributes 
this year $420 million to States for the provision of community-based 
mental health services to adults with serious mental illness and 
children with serious emotional disturbance. While there is no 
statutory requirement that regulations be developed, the statute does 
give the Secretary the authority and responsibility of determining 
whether States have complied with the requirements of the statute. This 
regulation establishes the criteria the Secretary will use in 
determining whether a Sate is in compliance with the requirements of 
the statute. In order for the Secretary to act on a determination of 
non-compliance, the Department must issue regulations clearly 
identifying for the States what they are required to do.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/00/01
Final Action                    06/00/02

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: State

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-AA08
_______________________________________________________________________


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


Substance Abuse and Mental Health Services Administration (SAMHSA)



_______________________________________________________________________




998.  SUBSTANCE ABUSE AND MENTAL HEALTH SERVICES ADMINISTRATION 
MENTAL HEALTH AND SUBSTANCE ABUSE EMERGENCY RESPONSE CRITERIA

Priority: Other Significant

Legal Authority: PL 106-310

CFR Citation: Not Yet Determined

Legal Deadline: None

Abstract: SAMHSA is drafting a regulation to define ``emergency'' for 
the purposes of implementing section 501(m) of the Public Health 
Service Act. Section 501(m) permits the Secretary to use up to 2.5 
percent of those funds appropriated for discretionary programs ``to 
make non-competitive, grants, contracts or cooperative agreements to 
public entities to enable such entities to address emergency substance 
abuse and mental health needs in local communities.''

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              10/11/01                    66 FR 51873
Final Rule                       To Be                       Determined

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

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-AA09
_______________________________________________________________________




999.  SECLUSION AND RESTRAINT FOR NON-MEDICAL RESIDENTIAL 
FACILITIES

Priority: Other Significant

Legal Authority: PL 106-310

CFR Citation: Not Yet Determined

Legal Deadline: NPRM, Statutory, April 17, 2001.

Abstract: These regulations will implement the requirements of part I 
of title V of the PHS Act which make certain requirements of non-
medical facilities for children which receive funds authorized by the 
PHS Act.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              06/00/02
Final Action                    12/00/02

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

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-AA10

[[Page 61570]]

_______________________________________________________________________


Department of Health and Human Services (HHS)         Completed Actions


Substance Abuse and Mental Health Services Administration (SAMHSA)



_______________________________________________________________________




1000. SUBSTANCE ABUSE PREVENTION AND TREATMENT BLOCK GRANT APPLICATIONS 
DUE DATE CHANGE FROM MARCH 31 TO OCTOBER 1 FOR FY 2001 AND BEYOND

Priority: Routine and Frequent

CFR Citation: 45 CFR 96; 45 CFR 96.122(d); 45 CFR 96.130(e); 45 CFR 
96.134(d)

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Rule                      07/21/00                    65 FR 45301

Regulatory Flexibility Analysis Required: No

Government Levels Affected: State

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

Agency Contact: Thomas Reynolds
Phone: 301 443-0179

RIN: 0930-AA04
_______________________________________________________________________




1001.  MANDATORY GUIDELINES FOR FEDERAL WORKPLACE DRUG TESTING 
PROGRAMS

Priority: Substantive, Nonsignificant

Legal Authority: 5 USC 7301

CFR Citation: None

Legal Deadline: None

Abstract: The Mandatory Guidelines for Federal Workplace Drug Testing 
Progrms (Mandatory Guidelines), as revised in the Federal Register on 
June 9, 1994 (59 FR 29908) and on September 30, 2997 (62 FR 51118), 
establish the scientific and technical guidelines for Federal workplace 
drug testing programs and establish standards for certification of 
laboratories engaged in urine drug testing for Federal agencies under 
authority Public Law 100-71, 5 U.S.C. 7301 note, and Exective Order 
12564.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Notice                          08/21/01                    66 FR 43876

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

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-AA07
_______________________________________________________________________


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


Centers for Disease Control and Prevention (CDC)



_______________________________________________________________________




1002. CONTROL OF COMMUNICABLE DISEASES

 Regulatory Plan: This entry is Seq. No. 27 in part II of this issue of 
the Federal Register.

RIN: 0920-AA03
_______________________________________________________________________




1003. AMENDMENTS TO QUALITY ASSURANCE AND ADMINISTRATIVE PROVISION 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(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                            02/00/02

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Roland Berry Ann, Team Leader, Policy Development, 
Respirator Branch, Department of Health and Human Services, Centers for 
Disease Control and Prevention, NIOSH, P04, 1095 Willowdale Road, 
Morgantown, WV 26505
Phone: 304 285-5907

RIN: 0920-AA04
_______________________________________________________________________




1004. METHODS FOR ESTIMATING RADIATION DOSE AND GUIDELINES FOR ASSESSING 
PROBABILITY OF CANCER FOR ENERGY EMPLOYEES OCCUPATIONAL ILLNESS 
COMPENSATION PROGRAM

Priority: Other Significant

Legal Authority: PL 106-398, sec 3623

CFR Citation: 42 CFR 81

Legal Deadline: None

Abstract: Pursant to Executive Order 13179, which implements section 
3623 of the Energy Employees Occupational Illness Compensation Program 
Act, Public Law 106-398, NIOSH plans to propose and finalize 
regulations to establish:
1) Guidelines to assess the likelihood that an individual with cancer 
sustained that cancer in the performance of duty at a Department of 
Energy facility, or an atomic weapons employer facility, as defined in 
that Act; and
2) Methods for arriving at, and providing reasonable estimates of, the 
radiation doses received by individuals applying for assistance under 
this program for whom there are inadequate records of radiation 
exposure.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/00/01

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: Undetermined

Agency Contact: Larry Elliott, Acting Director, Office of Compensation 
Analysis and Support, Department of Health and Human Services, Centers 
for Disease Control and Prevention,

[[Page 61571]]

NIOSH, R44, 5555 Ridge Avenue, Cincinnati, OH 45213
Phone: 513 841-4400

RIN: 0920-AA05
_______________________________________________________________________


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


Centers for Disease Control and Prevention (CDC)



_______________________________________________________________________




1005. PACKAGING AND HANDLING OF INFECTIOUS SUBSTANCES AND SELECT AGENTS

Priority: Other Significant

Legal Authority: 42 USC 264; 42 USC 271; 42 USC 262 note; 31 USC 9701; 
18 USC 3559; 18 USC 3571

CFR Citation: 42 CFR 72.6 (Renumbered); 42 CFR 72.7 (Renumbered); 42 
CFR 72.1-5 (Revision)

Legal Deadline: None

Abstract: The purpose of this NPRM is to update regulations governing 
the packaging, labeling, and shipment of infectious agents. Materials 
must be packaged in such a way as to prevent damage and leakage during 
transport in order to protect workers and the public from exposure.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            10/28/99                    64 FR 58022


Next Action Undetermined

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Federalism:  Undetermined

Agency Contact: Dr. Jonathan Y. Richmond, Director, Office on Health 
and Safety, Department of Health and Human Services, Centers for 
Disease Control and Prevention, MS F05, 1600 Clifton Road NE, Atlanta, 
GA 30333
Phone: 404 639-2453

RIN: 0920-AA02
_______________________________________________________________________


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


Departmental Management (HHSDM)



_______________________________________________________________________




1006. IMPLEMENTATION OF THE EQUAL ACCESS TO JUSTICE ACT IN AGENCY 
PROCEEDINGS

Priority: Substantive, Nonsignificant

Legal Authority: 5 USC 504(c)(1)

CFR Citation: 45 CFR 13

Legal Deadline: None

Abstract: The Equal Access to Justice Act requires agencies to pay fees 
to parties prevailing against the Government in certain administrative 
proceedings. The Act has been amended several times since its 1980 
enactment, most recently by the Contract with America Advancement Act 
of 1996, which increased the amount of the hourly fees payable. The 
proposed rule revises 45 CFR part 13 (HHS regulation implementing the 
Equal Access to Justice Act) to conform with statutory changes.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/19/87                    52 FR 23311
NPRM Comment Period End         08/17/87
Second NPRM                     02/00/02

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Timothy M. White, Associate General Counsel, Business 
and Administrative Law Division, Department of Health and Human 
Services, Room 5362, HHS Cohen Building, 330 Independence Avenue SW., 
Washington, DC 20201
Phone: 202 619-0150

RIN: 0990-AA02
_______________________________________________________________________




1007.  ADMINISTRATIVE WAGE GARNISHMENT

Priority: Substantive, Nonsignificant

Legal Authority: 31 USC 3720D; 28 CFR 285.11

CFR Citation: 42 CFR 32

Legal Deadline: None

Abstract: The Department will add a new part 32 to title 42 of the Code 
of Federal Regulations (CFR) to implement the Administrative Wage 
Garnishment provisions of the Debt Collection Improvement Act of 1996 
(DCIA), Public Law 104-134, 110 Stat 1321-358, codified at 31 U.S.C 
3720D, and implemented by the Department of Treasury at 31 C.F.R. 
285.11. The proposed rule will be another tool for the Department to 
collect its debts by allowing the Department to garnish the wages of 
non-Federal employees administratively (i.e., without the need for a 
court order). The wage withholding order will be required to withold 
amounts from an employee's wages and pay those amounts to the 
Department in satisfaction of the indebtedness.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            01/00/02

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Timothy M. White, Associate General Counsel, Business 
and Administrative Law Division, Department of Health and Human 
Services, Room 5362, HHS Cohen Building, 330 Independence Avenue SW., 
Washington, DC 20201
Phone: 202 619-0150

RIN: 0990-AA05

[[Page 61572]]

_______________________________________________________________________


Department of Health and Human Services (HHS)             Prerule Stage


Food and Drug Administration (FDA)



_______________________________________________________________________




1008. NATURAL RUBBER-CONTAINING DRUGS; USER LABELING

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

Unfunded Mandates: Undetermined

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

CFR Citation: 21 CFR 201

Legal Deadline: None

Abstract: The advance notice of proposed rulemaking requests comments 
on requirements under consideration for labeling statements on products 
regulated as drugs (including combination products regulated under drug 
labeling provisions) that contain natural rubber that contacts humans.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

ANPRM                           04/00/02

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Federalism:  Undetermined

Agency Contact: Carol Drew, 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, 1451 Rockville Pike, Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562

RIN: 0910-AB56
_______________________________________________________________________




1009.  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; 21 USC 356b; 21 USC 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

________________________________________________________________________

ANPRM                           02/00/02

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Aida L. Sanchez, Special Assistant to the Director, 
Department of Health and Human Services, Food and Drug Administration, 
HFD-650, Center for Drug Evaluation and Research, 5600 Fishers Lane, 
Rockville, MD 20857
Phone: 301 827-5847

RIN: 0910-AC23
_______________________________________________________________________




1010.  REQUIREMENTS FOR MEDICAL GAS CONTAINERS AND CLOSURE 
SYSTEMS

Priority: Substantive, Nonsignificant

Legal Authority: Not Yet Determined

CFR Citation: Not Yet Determined

Legal Deadline: None

Abstract: The proposed rule would revise Food and Drug Administration 
regulations to require that medical gas manufacturers configure medical 
gas containers and closure systems, and provide training to personnel, 
to help avoid the risk of administration of the improper gas to 
patients.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

ANPRM                           02/00/02

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected: Businesses

Government Levels Affected: Undetermined

Federalism:  Undetermined

Agency Contact: Lee D. Korb, 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, 1451 Rockville Pike, Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562

RIN: 0910-AC24
_______________________________________________________________________


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


Food and Drug Administration (FDA)



_______________________________________________________________________




1011. OVER-THE-COUNTER (OTC) DRUG REVIEW

Priority: Routine and Frequent

Legal Authority: 21 USC 321p; 21 USC 351; 21 USC 352; 21 USC 353; 21 
USC 355; 21 USC 360a; 21 USC 371a; 21 USC 331; 21 USC 360; 21 USC 360b; 
21 USC 361; 21 USC 371

CFR Citation: 21 CFR 310; 21 CFR 340; 21 CFR 341; 21 CFR 342; 21 CFR 
343; 21 CFR 344; 21 CFR 345; 21 CFR 330; 21 CFR 333; 21 CFR 334; 21 CFR 
335; 21 CFR 336; 21 CFR 337; 21 CFR 338; 21 CFR 339

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. NOTE: NPRM for 
``Antidotes, Toxic Ingestion Products'' was combined with NPRM for 
``Emetic

[[Page 61573]]

Products'' and reproposed as ``Poison Treatment Products.'' NPRM for 
``Astringent (Wet Dressings) Products'' was included in the NPRM for 
``Skin Protectant Products.'' NPRM for ``Diaper Rash Products'' was 
included in NPRMs for ``Antifungal,'' ``Antimicrobial,'' ``External 
Analgesic'' and ``Skin Protectant Products.'' NPRM for ``Fever Blister/
Cold Sore Products (External)'' was included in NPRMs for ``External 
Analgesic'' and ``Skin Protectant Products.'' NPRM for ``Insect Bites 
and Stings (Relief) Products'' was included in NPRMs for ``External 
Analgesic'' and ``Skin Protectant Products.'' ``Poison Ivy/Oak/Sumac 
Prevention'' was included in NPRMs for ``External Analgesic'' and 
``Skin Protectant Products.'' NPRM for ``Mercurial (Topical) Products'' 
was included in revised NPRM for ``Antimicrobial Products.'' NPRM for 
``Alcohol (Topical) Products'' was included in revised NPRM for 
``Antimicrobial Products.'' The NPRM for ``Antimicrobial Products'' was 
updated and split into two sections: First Aid Products and Health Care 
Antiseptic Products.
SMALL ENTITIES AFFECTED: The effects, if any, vary depending on the 
individual rulemaking. However, the Agency anticipates that the rules 
would not have a significant economic impact on a substantial number of 
small entities as defined by the Regulatory Flexibility Act.

Timetable:
________________________________________________________________________

Acne (Topical) Products  ANPRM 03/23/82 (47 FR 12430)  NPRM 01/15/85 
(50 FR 2172)  NPRM (Amendment) 08/07/91 (56 FR 37622)  Final Action 08/
16/91 (56 FR 41008)

Alcohol (Oral) in OTC Drug Products  NPRM 10/21/93 (58 FR 54466)  Final 
Action 03/13/95 (60 FR 13590)  NPRM (Amendment) 05/10/96 (61 FR 
21392)  Final Action (Amendment) 11/18/96 (61 FR 58629)

Anorectal Products  ANPRM 05/27/80 (45 FR 35576)  NPRM 08/15/88 (53 FR 
30756)  Final Action 08/03/90 (55 FR 31776)  Final Action (LYCD) 09/02/
93 (58 FR 46746)  Final Action (Witch Hazel) 06/03/94 (59 FR 28766)

Antacid Drug Products  ANPRM 04/05/73 (38 FR 8714)  NPRM 11/12/73 (38 
FR 31260)  Final Action 06/04/74 (39 FR 9862)  NPRM (Amendment) 
(Overindulgence) 12/24/91 (56 FR 66754)  Final Action (Amendment) 
(Warning) 08/26/93 (58 FR 45204)  NPRM (Amendment) (Testing) 09/23/93 
(58 FR 49826)  NPRM (Amendment)(Sodium Bicarb.) 02/02/94 (59 FR 
5060)  Final Action (Technical Amendment) 11/25/94 (59 FR 60555)  Final 
Action (Amendment) (Testing) 02/08/96 (61 FR 4822)  Final Action 
(Amendment)(Sodium B.) 12/00/02  Final Action (Amendment) 
(Overindulgence) 12/00/02

Anthelmintic Products  ANPRM 09/09/80 (45 FR 59541)  NPRM 08/24/82 (47 
FR 37062)  Final Action 08/01/86 (51 FR 27756)

Antibiotic First Aid Products  ANPRM 04/01/77 (42 FR 17642)  NPRM 07/
09/82 (47 FR 29986)  Final Action 12/11/87 (52 FR 47312)  NPRM 
(Amendment) 08/18/89 (54 FR 34188)  Final Action 03/15/90 (55 FR 
9721)  NPRM (Amendment) 05/11/90 (55 FR 19868)  NPRM (Amendment) 06/08/
90 (55 FR 23450)  Final Action (Amendment) 10/03/90 (55 FR 
40379)  Final Action (Amendment) 12/05/90 (55 FR 50171)  NPRM 
(Amendment) (Warning) 02/14/96 (61 FR 5918)  Final Action 
(Amendment)(Warning) 11/15/96 (61 FR 58471)

Anticaries Products  ANPRM 03/28/80 (45 FR 20666)  NPRM 09/30/85 (50 FR 
39854)  NPRM 06/15/88 (53 FR 22430)  Final Action 10/06/95 (60 FR 
52474)  Final Action (Technical Amendment) 10/07/96 (61 FR 52285)

Antidiarrheal Products  ANPRM 03/21/75 (40 FR 12924)  NPRM 04/30/86 (51 
FR 16138)  NPRM (Amendment)(Trav. Diar.) 04/00/02  Final Action 04/00/
02

Antidotes, Toxic Ingestion Prdts (New Poison Treatment Prdts)  ANPRM 
01/05/82 (47 FR 444)

Antiemetic Products  ANPRM 03/21/75 (40 FR 12934)  NPRM 07/13/79 (44 FR 
41064)  Final Action 04/30/87 (52 FR 15886)  NPRM (Amendment) 08/26/93 
(58 FR 45216)  Final Action 04/11/94 (59 FR 16981)  NPRM 
(Amendment)(Warning) 08/29/97 (62 FR 45767)  Final Action (Amendment) 
(Warning) 03/00/02

Antiflatulent Drug Products  NPRM 11/12/73 (38 FR 31260)  Final Action 
06/04/74 (39 FR 19877)  NPRM (Amendment) 01/29/88 (53 FR 2716)  Final 
Action (Amendment) 03/05/96 (61 FR 8836)

Antifungal (Topical) Products  ANPRM 03/23/82 (47 FR 12480)  NPRM 12/
12/89 (54 FR 51136)  NPRM (Amendment) (Diaper Rash) 06/20/90 (55 FR 
25240)  Final Action (Amdt.)(Diaper Rash) 12/18/92 (57 FR 60430)  Final 
Action (Partial) 09/02/93 (58 FR 46744)  Final Action 09/23/93 (58 FR 
49890)  NPRM (Amendment) (Indications) 07/22/99 (64 FR 39452)  Final 
Action 08/29/00 (65 FR 52302)  NPRM (Amendment) Clotrimazole 05/29/01 
(66 FR 29059)  Final Action Clotrimazole 04/00/02

Antimicrobial Products  ANPRM 09/13/74 (39 FR 33103)  NPRM 01/06/78 (43 
FR 1210)  NPRM (Amendment) (Diaper Rash) 06/20/90 (55 FR 25246)  Final 
Action (Diaper Rash) 03/00/04

Antiperspirant Products  ANPRM 10/10/78 (43 FR 46694)  NPRM 08/20/82 
(47 FR 36492)  Final Action 09/00/02

Aphrodisiac Products  ANPRM 10/01/82 (47 FR 43572)  NPRM 01/15/85 (50 
FR 2168)  Final Action 07/07/89 (54 FR 28780)

Astringent (Wet Dressings) Prdts (Merged w/other rulemkg)  ANPRM 09/07/
82 (47 FR 39436)

Benign Prostatic Hypertrophy Products  ANPRM 10/01/82 (47 FR 
43566)  NPRM 02/20/87 (52 FR 5406)  Final Action 02/27/90 (55 FR 6926)

Boil Ointments  ANPRM 06/29/82 (47 FR 28306)  NPRM 01/26/88 (53 FR 
2198)  Final Action 11/15/93 (58 FR 60332)

Camphorated Oil Drug Products  ANPRM 09/26/80 (45 FR 63869)  Final 
Action 09/21/82 (47 FR 41716)

Cholecystokinetic Products  ANPRM 02/12/80 (45 FR 9286)  NPRM 08/24/82 
(47 FR 37068)  Final Action 06/10/83 (48 FR 27004)  NPRM (Amendment) 
08/15/88 (53 FR 30786)  Final Action (Amendment) 02/28/89 (54 FR 8320)

Corn and Callus Remover Products  ANPRM 01/05/82 (47 FR 522)  NPRM 02/
20/87 (52 FR 5412)  Final Action 08/14/90 (55 FR 33258)

Cough/Cold (Anticholinergic) Products  ANPRM 09/09/76 (41 FR 
38312)  NPRM 07/09/82 (47 FR 30002)  Final Action 11/08/85 (50 FR 
46582)

[[Page 61574]]

Cough/Cold (Antihistamine) Products  ANPRM 09/09/76 (41 FR 38312)  NPRM 
01/15/85 (50 FR 2200)  NPRM (Amendment) 08/24/87 (52 FR 31892)  Final 
Action 12/09/92 (57 FR 58356)  Final Action (Amendment)(Warning) 01/28/
94 (59 FR 4216)  NPRM (Amendment)(Warning) 08/29/97 (62 FR 
45767)  Reopen Record (Common Cold) 08/25/00 (65 FR 51780)  Final 
Action (Amendment)(Warning) 03/00/02  Final Action 12/00/02

Cough/Cold (Antitussive) Products  ANPRM 09/09/76 (41 FR 38312)  NPRM 
10/19/83 (48 FR 48576)  Final Action 08/12/87 (52 FR 30042)  NPRM 
(Amendment) (Warning) 07/06/89 (54 FR 28442)  NPRM (Amendment) 10/02/89 
(54 FR 40412)  Final Action (Amendment) (Warning) 07/06/90 (55 FR 
27806)  Final Action (Amendment) 10/03/90 (55 FR 40381)  NPRM 
(Amendment)(Warning) 06/19/92 (57 FR 27666)  NPRM 
(Amendment)(Ingredients) 12/09/92 (57 FR 58378)  Final Action 
(Amendment)(Warning) 10/20/93 (58 FR 54232)  Final Action 
(Amdt.)(Ingredients) 06/03/94 (59 FR 29172)  NPRM (Amendment)(Warning) 
08/29/97 (62 FR 45767)  NPRM (Amendment)(Flammability) 07/20/98 (63 FR 
38762)  Final Action (Amendment)(Flammability) 08/01/00 (65 FR 
46864)  Final Action (Amendment)(Warning) 03/00/02

Cough/Cold (Bronchodilator) Products  ANPRM 09/09/76 (41 FR 
38312)  NPRM 10/26/82 (47 FR 47520)  Final Action 10/02/86 (51 FR 
35326)  NPRM (Amendment)(Warning) 06/19/92 (57 FR 27662)  Final Action 
(Amendment)(Warning) 10/20/93 (58 FR 54238)  NPRM (Amendment)(MDI) 03/
09/95 (60 FR 13014)  NPRM (Amendment)(Ephedrine) 07/27/95 (60 FR 
38643)  Final Action (Amendment) (MDI) 05/20/96 (61 FR 25142)  Final 
Action (Amendment) (Ephedrine) 12/00/02

Cough/Cold (Combination) Products  ANPRM 09/09/76 (41 FR 38312)  NPRM 
08/12/88 (53 FR 30522)  NPRM (Amendment)(DPH Combinations) 02/23/95 (60 
FR 10286)  Final Action (Theophylline) 07/27/95 (60 FR 38636)  Final 
Action 09/00/02  NPRM (Amendment) (Ephedrine Combo) 12/00/02

Cough/Cold (Diphenhydramine) Products  Final Action/Enforcement Policy 
04/09/96 (61 FR 15700)

Cough/Cold (Expectorant) Products  ANPRM 09/09/76 (41 FR 38312)  NPRM 
07/09/82 (47 FR 30002)  Final Action 02/28/89 (54 FR 8494)  Final 
Action (Technical Changes) 06/30/92 (57 FR 29176)

Cough/Cold (Expectorant/Ipecac) Products  ANPRM 09/09/76 (41 FR 
38312)  NPRM 07/09/82 (47 FR 30002)  Final Action 09/14/92 (57 FR 
41857)

Cough/Cold (Nasal Decongestant) Products  ANPRM 09/09/76 (41 FR 
38312)  NPRM 01/15/85 (50 FR 2220)  NPRM (Amendment) 06/19/92 (57 FR 
27658)  Final Action 08/23/94 (59 FR 43386)  Final Action; Partial Stay 
03/08/96 (61 FR 9570)  Final Action (Amendment)(Levmetamfetamine) 07/
30/98 (63 FR 40647)  NPRM (Phenylpropanolamine) 04/00/02

Dandruff, Seborrheic Dermatitis and Psoriasis Control Products  ANPRM 
12/03/82 (47 FR 54646)  NPRM 07/30/86 (51 FR 27346)  Final Action 12/
04/91 (56 FR 63554)  NPRM (Amendment) 04/05/93 (58 FR 17554)  Final 
Action 01/28/94 (59 FR 4000)

Daytime Sedatives  ANPRM 12/08/75 (40 FR 57292)  NPRM 06/13/78 (43 FR 
25544)  Final Action 06/22/79 (44 FR 36378)

Diaper Rash Products (Merged w/other rulemkg)  ANPRM 09/07/82 (47 FR 
39406)

Digestive Aid Products  ANPRM 01/05/82 (47 FR 454)  NPRM 01/29/88 (53 
FR 2706)  Final Action 10/21/93 (58 FR 54450)

Eligibility Criteria for Additional Conditions  ANPRM 10/03/96 (61 FR 
51625)  NPRM 12/20/99 (64 FR 71062)  Final Action 04/00/02

Emetic Products  ANPRM 03/21/75 (40 FR 12939)  NPRM 09/05/78 (43 FR 
39544)

Exocrine Pancreatic Insufficiency Products  ANPRM 12/21/79 (44 FR 
75666)  NPRM 11/08/85 (50 FR 46594)  NPRM (Reproposed) 07/15/91 (56 FR 
32282)  Final Action 04/24/95 (60 FR 20162)

External Analgesic Products  ANPRM 12/04/79 (44 FR 69768)  NPRM 02/08/
83 (48 FR 5852)  NPRM (Amendment) (Dandruff) 07/30/86 (51 FR 
27360)  NPRM (Amendment) (Anorectal) 08/25/88 (53 FR 32592)  NPRM 
(Amendment) (Poison Ivy) 10/03/89 (54 FR 40818)  NPRM (Amendment) (Fvr 
Blister/Ext) 01/31/90 (55 FR 3370)  NPRM (Amendment) (1%Hydrocortisone) 
02/27/90 (55 FR 6932)  NPRM (Amendment) (Diaper Rash) 06/20/90 (55 FR 
25234)  Final Action (Diaper Rash) 12/18/92 (57 FR 60426)  NPRM 
(Amendment)(Warning) 08/29/97 (62 FR 45767)  Final Action 
(Amendment)(Warning) 03/00/02

Fever Blister Products (Internal)  ANPRM 01/05/82 (47 FR 502)  NPRM 06/
17/85 (50 FR 25156)  Final Action 06/30/92 (57 FR 29166)

First Aid Antiseptic  ANPRM 09/13/74 (39 FR 33103)  NPRM 01/06/78 (43 
FR 1210)  NPRM (Revised) 07/22/91 (56 FR 33644)

Fvr Blister/Cold Sore Prdts (Ext.) (To be merged w/other 
rulemkg)  ANPRM 09/07/82 (47 FR 39436)

Hair Grower and Hair Loss Prevention Products  ANPRM 11/07/80 (45 FR 
73955)  NPRM 01/15/85 (50 FR 2190)  Final Action 07/07/89 (54 FR 28772)

Healthcare Antiseptic Products  ANPRM 09/13/74 (39 FR 33103)  NPRM 01/
06/78 (43 FR 1210)  NPRM (Revised) 06/17/94 (59 FR 31402)  Final Action 
12/00/02

Hormone (Topical) Products  ANPRM 01/05/82 (47 FR 430)  NPRM 10/02/89 
(54 FR 40618)  Final Action 09/09/93 (58 FR 57608)

Hypo/Hyperphosphatemia Products  ANPRM 12/09/80 (45 FR 81154)  NPRM 01/
15/85 (50 FR 2160)  Final Action 05/11/90 (55 FR 19852)

Ingrown Toenail Relief Products  ANPRM 10/17/80 (45 FR 69128)  NPRM 09/
03/82 (47 FR 39120)  Final Action 09/09/93 (58 FR 47602)  NPRM 03/00/02

Insect Bite & Sting (Relief) Prdts (Merged w/other rulemkg)  ANPRM 09/
07/82 (47 FR 39412)

Insect Repellent Drug Products (Internal)  ANPRM 01/05/82 (47 FR 
424)  NPRM 06/10/83 (48 FR 26986)  Final Action 06/17/85 (50 FR 25170)

[[Page 61575]]

Internal Analgesic Products  ANPRM 07/08/77 (42 FR 35346)  NPRM 11/16/
88 (53 FR 46204)  NPRM (Amendment) (Overindulgence) 12/24/91 (56 FR 
66762)  NPRM 10/20/93 (58 FR 54224)  NPRM (Amendment)(Sodium 
Bicarbonate) 02/02/94 (59 FR 5068)  NPRM (Prof. Labeling)(Acute MI) 06/
13/96 (61 FR 30002)  NPRM (Amendment)(Alcohol Warning) 11/14/97 (62 FR 
61041)  Final Action (Alcohol Warning) 10/23/98 (63 FR 56789)  Final 
Action (Aspirin Prof. Label) 10/23/98 (63 FR 56802)  NPRM 
(Amendment)(Ibuprofen) 04/00/02  Final Action 12/00/02  Final Action 
(Sodium Bicarbonate) 12/00/02  Final Action (Amendment)(Overindulgence) 
12/00/02

Internal Deodorant Products  ANPRM 01/05/82 (47 FR 512)  NPRM 06/17/85 
(50 FR 25162)  Final Action 05/11/90 (55 FR 19862)

Labeling of Drug Products for OTC Human Use  NPRM (Sodium Labeling) 04/
25/91 (56 FR 19222)  NPRM 04/05/93 (58 FR 17553)  Final Action 01/28/94 
(59 FR 3998)  NPRM (Do not mix drugs) 08/03/94 (59 FR 39499)  NPRM 
(Amendment) (Do not mix drugs) 10/04/95 (60 FR 52058)  NPRM (Unless a 
doctor tells you) 03/04/96 (61 FR 8450)  Final Action (Sodium Labeling) 
04/22/96 (61 FR 17798)  NPRM (Calcium/Magnesium/Potassium) 04/22/96 (61 
FR 17807)  Withdrawal (Unless a doctor tells you) 02/27/97 (62 FR 
9024)  Final Action (Format/Examples) 03/17/99 (64 FR 13254)  Final 
Action (Technical Amendment) 01/03/00 (65 FR 7)  Final Action (Ca/Mg/K/
Na) 12/00/01

Laxative Products  ANPRM 03/21/75 (40 FR 12902)  NPRM 01/15/85 (50 FR 
2124)  NPRM (Amendment) (Directions/Bulk) 10/01/86 (51 FR 35136)  NPRM 
(Amendment) (Docusate Salts) 09/02/93 (58 FR 46589)  NPRM 
(Amendment)(Sodium Phosphates) 03/31/94 (59 FR 15139)  NPRM 
(Phenolphthalein) 09/02/97 (62 FR 46223)  Final Action (Sodium 
Phosphates) 05/21/98 (63 FR 27836)  NPRM (Amendment)(Phosphates Label) 
05/21/98 (63 FR 27886)  NPRM (Amendment)(Stim. Laxative) 06/19/98 (63 
FR 33592)  Final Action; stay (Na Phos. Enema) 12/07/98 (63 FR 
67399)  Part. With. (Na Phos. Prof. Lab.) 12/09/98 (63 FR 67817)  Final 
Action (Phenolphthalein) 01/29/99 (64 FR 4535)  Final Action 12/00/
02  Final Action (Stim. Laxative) 12/00/03

Leg Muscle Cramps (Nocturnal Relief) Products  ANPRM 10/01/82 (47 FR 
43562)  NPRM 11/08/85 (50 FR 46588)  Final Action 08/22/94 (59 FR 
43234)

Male Genital Desensitizer Products  ANPRM 09/07/82 (47 FR 39412)  NPRM 
10/02/85 (50 FR 40260)  Final Action 06/19/92 (57 FR 27654)

Menstrual Products  ANPRM 12/07/82 (47 FR 55075)  NPRM 11/16/88 (53 FR 
46194)  Final Action 12/00/02

Mercurial (Topical) Products (To be merged w/other rulemkg)  ANPRM 01/
05/82 (47 FR 436)

NDA Labeling Exclusivity (Merged with other rulemaking)  NPRM 11/09/93 
(58 FR 59622)

Nailbiting/Thumbsucking Deterrent Products  ANPRM 10/17/80 (45 FR 
69122)  NPRM 09/03/82 (47 FR 39096)  Final Action 09/02/93 (58 FR 
46749)

Nighttime Sleep Aid Products  ANPRM 12/08/75 (40 FR 57292)  NPRM 06/13/
78 (43 FR 25544)  Final Action 02/14/89 (54 FR 6814)  NPRM (Amendment) 
08/26/93 (58 FR 45217)  Final Action (Amendment) 04/11/94 (59 FR 
16982)  NPRM (Amendment)(Warning) 08/29/97 (62 FR 45767)  Final Action 
(Amendment)(Warning) 03/00/02

Ophthalmic Products  ANPRM 05/06/80 (45 FR 30002)  NPRM 06/28/83 (48 FR 
29788)  Final Action 03/04/88 (53 FR 7076)  Final Action (Anti-
infective) 12/18/92 (57 FR 60416)  NPRM (Amendment) (Warning) 02/23/98 
(63 FR 8888)  Final Action 06/21/00 (65 FR 38426)

Oral Discomfort (Relief) Products  ANPRM 05/25/82 (47 FR 22712)  NPRM 
09/24/91 (56 FR 48302)  Final Action 06/00/03

Oral Health Care Products  ANPRM 05/25/82 (47 FR 22760)  NPRM 01/27/88 
(53 FR 2436)  NPRM (Amendment) (Antimicrobials) 02/09/94 (59 FR 
6084)  ANPRM (Plaque/Gingivitis) 06/00/02

Oral Wound Healing Products  ANPRM 11/02/79 (44 FR 63270)  NPRM 07/26/
83 (48 FR 33984)  Final Action 07/18/86 (51 FR 26112)

Otic Products (Dry Water-Clogged Ears)  NPRM (Amendment) 08/17/99 (64 
FR 44671)  Final Action 08/10/00 (65 FR 48902)

Otic Products (Earwax)  NPRM 07/09/82 (47 FR 30012)  Final Action 08/
08/86 (51 FR 28656)

Otic Products (Swimmers Ear)  NPRM 07/30/86 (51 FR 27366)  Final Action 
02/15/95 (60 FR 8916)  Final Action Partial Stay 08/16/95 (60 FR 42435)

Overindulgence Remedies  ANPRM 10/01/82 (47 FR 43540)  NPRM 12/24/91 
(56 FR 66742)  Final Action 12/00/02

Overindulgence Remedies/Prevention of Inebriation  ANPRM 10/01/82 (47 
FR 43540)  Final Action 07/19/83 (48 FR 32872)

Pediculicide Products  ANPRM 06/29/82 (47 FR 28312)  NPRM 04/03/89 (54 
FR 13480)  Final Action 12/14/93 (58 FR 65452)  NPRM (Labeling 
Amendment) 04/00/02

Phenylpropanolamine Products (Labeling)  NPRM 02/14/96 (61 FR 3912)

Poison Ivy/Oak/Sumac Prevention (Merged w/other rulemkg)  ANPRM 09/07/
82 (47 FR 39412)

Poison Treatment Products  NPRM 01/15/85 (50 FR 2244)  Final Action 12/
00/02  NPRM (Amendment) 12/00/02

Quinine for Malaria  NPRM 04/19/95 (60 FR 19650)  Final Action 03/20/98 
(63 FR 13526)

Salicylate (Reye Syndrome)  NPRM (Amendment)(Warning) 05/05/93 (58 FR 
26886)  ANPRM 10/20/93 (58 FR 54228)  Final Action (Warning) 04/00/02

Skin Bleaching Products  ANPRM 11/03/78 (43 FR 51546)  NPRM 09/03/82 
(47 FR 39108)  NPRM (Reproposed) 01/00/03

[[Page 61576]]

Skin Protectant Products  ANPRM 08/04/78 (43 FR 34628)  NPRM 02/15/83 
(48 FR 6820)  NPRM (Amendment) (Astringent) 04/03/89 (54 FR 
13490)  NPRM (Amendment) (Poison Ivy) 10/03/89 (54 FR 40808)  NPRM 
(Amendment) (Fvr Blister/Ext) 01/31/90 (55 FR 3362)  NPRM (Amendment) 
(Diaper Rash) 06/20/90 (55 FR 25204)  Final Action (Astringent) 10/21/
93 (58 FR 54466)  Final Action (Witch Hazel) 06/03/94 (59 FR 
28767)  Final Action (Poison Ivy) 11/00/01  Final Action 11/00/
01  Final Action (Astringent) 12/00/01

Smoking Deterrent Products  ANPRM 01/05/82 (47 FR 490)  NPRM 07/03/85 
(50 FR 27552)  Final Action 06/01/93 (58 FR 31236)

Status of Certain Category II and III Ingredients  NPRM 05/16/90 (55 FR 
20434)  Final Action 11/07/90 (55 FR 46914)  NPRM 08/25/92 (57 FR 
38568)  Final Action 05/10/93 (58 FR 27636)  Final Action 04/22/98 (63 
FR 19799)  Final Action 08/24/98 (63 FR 44996)  Final Action 09/27/01 
(66 FR 49276)  Final Action 12/00/01

Stimulant (Overindulgence) Products  NPRM (Amendment) 12/24/91 (56 FR 
66758)  Final Action 12/00/02

Stimulant Products  ANPRM 12/08/75 (40 FR 57292)  NPRM 06/13/78 (43 FR 
25544)  Final Action 02/29/88 (53 FR 6100)

Stomach Acidifier Products  ANPRM 10/19/79 (44 FR 60316)  NPRM 01/15/85 
(50 FR 2184)  Final Action 08/17/88 (53 FR 31270)

Sunscreen Products  ANPRM 08/25/78 (43 FR 38206)  NPRM 05/12/93 (58 FR 
28194)  NPRM (Amendment) 06/08/94 (59 FR 29706)  NPRM 
(Amendment)(Avobenzone) 09/16/96 (61 FR 48645)  Final Action 
(Avobenzone Enf. Pol.) 04/30/97 (62 FR 23350)  Final Action 05/21/99 
(64 FR 27666)  ANPRM (and Insect Repellant) 12/00/01  NPRM (UVA/UVB) 
06/00/02

Sweet Spirits of Nitre  ANPRM 02/22/80 (45 FR 11846)  Final Action 06/
27/80 (45 FR 43400)

Topical Drug Products Containing Benzoyl Peroxide (Labeling)  NPRM 02/
17/95 (60 FR 9554)  Final Action 12/00/02

Vaginal Contraceptive Products  ANPRM 12/12/80 (45 FR 82014)  NPRM 02/
03/95 (60 FR 6892)  NPRM (Amendment) 06/00/02

Vaginal Drug Products  ANPRM 10/13/83 (48 FR 46694)  Withdrawal 02/03/
95 (60 FR 5226)  NPRM (Douches) 12/00/02

Vitamin/Mineral Products  ANPRM 03/16/79 (44 FR 16126)  Withdrawal 11/
27/81 (46 FR 57914)

Wart Remover Products  ANPRM 10/03/80 (45 FR 65609)  NPRM 09/03/82 (47 
FR 39102)  NPRM (Amendment) 03/27/87 (52 FR 9992)  Final Action 08/14/
90 (55 FR 33246)  NPRM (Amendment)(Directions) 01/28/94 (59 FR 
4015)  Final Action (Amdt.)(Directions) 11/23/94 (59 FR 60315)

Water Soluble Gums  NPRM 10/30/90 (55 FR 45782)  Final Action 08/26/93 
(58 FR 45194)  NPRM 12/00/02

Weight Control Products  ANPRM 02/26/82 (47 FR 8466)  NPRM 10/30/90 (55 
FR 45788)  Final Action 08/08/91 (56 FR 37792)  NPRM 
(Phenylpropanolamine) 04/00/02

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

RIN: 0910-AA01
_______________________________________________________________________




1012. ESTABLISHMENT REGISTRATION AND PRODUCT LISTING FOR DRUGS AND 
BIOLOGICS

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

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

CFR Citation: 21 CFR 201; 21 CFR 207; 21 CFR 314

Legal Deadline: None

Abstract: The proposed rule would amend FDA regulations on the 
registration of producers of drugs and the listing of drugs in 
commercial distribution. The proposed revisions would reorganize, 
consolidate, clarify, and modify current regulations concerning who 
must register establishments and list drug or biological products. The 
proposal describes when, how, and where to register and list and what 
information must be submitted for registration and listing. The 
proposed regulations would also require the electronic submission of 
most registration and listing information.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            04/00/02

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Federalism:  Undetermined

Agency Contact: Howard P. Muller, Office of Regulatory Policy, 
Department of Health and Human Services, Food and Drug Administration, 
Suite 3037 (HFD-7), Center for Drug Evaluation and Research, 1451 
Rockville Pike, Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562

RIN: 0910-AA49
_______________________________________________________________________




1013. 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; 21 USC 352; 21 USC 
353; 21 USC 355; 21 USC 371

CFR Citation: 21 CFR 312.110

Legal Deadline: None

Abstract: The proposed rule would amend the regulations on the 
exportation of unapproved new drug products, including biological 
products, for investigational use. In general, the proposed 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

[[Page 61577]]

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.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            02/00/02

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, Planning and Legislation, 5600 Fishers Lane, 
Rockville, MD 20857
Phone: 301 827-0587
Fax: 301 827-4774
Email: [email protected]

RIN: 0910-AA61
_______________________________________________________________________




1014. SAFETY REPORTING AND RECORDKEEPING REQUIREMENTS FOR MARKETED OTC 
DRUGS

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

Unfunded Mandates: Undetermined

Legal Authority: 21 USC 321; 21 USC 374; 21 USC 375; 21 USC 379; 42 USC 
216; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 358; 21 USC 360; 
21 USC 371

CFR Citation: 21 CFR 201; 21 CFR 211; 21 CFR 327; 21 CFR 330

Legal Deadline: None

Abstract: The proposed rule would require manufacturers of marketed 
nonprescription human drug products to report to FDA information they 
receive about adverse drug reactions, maintain records of adverse drug 
reactions, and permit access by FDA to adverse drug reaction records.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            08/00/02

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Federalism:  Undetermined

Agency Contact: Audrey Thomas, Regulatory Policy Analyst, Office of 
Regulatory Policy, Department of Health and Human Services, Food and 
Drug Administration, Suite 3037 (HFD-7), Center for Drug Evaluation and 
Research, 1451 Rockville Pike, Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562

RIN: 0910-AA86
_______________________________________________________________________




1015. SAFETY REPORTING REQUIREMENTS FOR HUMAN DRUG AND BIOLOGICAL 
PRODUCTS

 Regulatory Plan: This entry is Seq. No. 28 in part II of this issue of 
the Federal Register.

RIN: 0910-AA97
_______________________________________________________________________




1016. RADIOACTIVE DRUGS FOR BASIC RESEARCH

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

Unfunded Mandates: Undetermined

Legal Authority: 21 USC 321; 21 USC 351; 21 USC 352; 21 USC 353; 21 USC 
355; 21 USC 371; 42 USC 262

CFR Citation: 21 CFR 361

Legal Deadline: None

Abstract: The proposed rule would update FDA's regulations on the use 
of radioactive drugs for basic research to reflect technological 
changes in the field of radiopharmaceuticals. The proposed rule would 
also clarify and correct certain provisions.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            08/00/02

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Federalism:  Undetermined

Agency Contact: Brian L. Pendleton, 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, 1451 Rockville Pike, Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562
Email: [email protected]

RIN: 0910-AB00
_______________________________________________________________________




1017. ADMINISTRATIVE PRACTICES AND PROCEDURES; ADVISORY OPINIONS AND 
GUIDELINES

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

Unfunded Mandates: Undetermined

Legal Authority: 15 USC 1451 to 1461; 42 USC 262; 42 USC 263b; 42 USC 
264; 21 USC 41 to 50; 21 USC 141 to 149; 21 USC 321 to 394; 21 USC 
467f; 21 USC 679; 21 USC 821; 21 USC 1034; 42 USC 201

CFR Citation: 21 CFR 10; 21 CFR 808

Legal Deadline: None

Abstract: This proposed rule would amend FDA regulations in 21 CFR part 
10 concerning advisory opinions.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            08/00/02

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Federalism:  Undetermined

Agency Contact: Mitchell Weitzman, 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, 1451 Rockville Pike, Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562

RIN: 0910-AB14

[[Page 61578]]

_______________________________________________________________________




1018. BLOOD INITIATIVE

Priority: Other Significant. 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 360; 21 USC 371; 21 USC 374; 42 USC 216; 42 USC 262; 42 USC 263; 
42 USC 263a; 42 USC 264

CFR Citation: 21 CFR 600; 21 CFR 601; 21 CFR 606; 21 CFR 607; 21 CFR 
610; 21 CFR 640; 21 CFR 660; 21 CFR 680

Legal Deadline: None

Abstract: In multiple rulemakings, the Food and Drug Administration is 
amending the biologics regulations by removing, revising, or updating 
specific regulations applicable to blood, blood components, Source 
Plasma and blood derivative products to be more consistent with current 
practices and to remove unnecessary or outdated requirements. This 
action is based on a comprehensive review of the regulations that has 
been performed by FDA. 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; the Institute of Medicine, as well as public 
comments. Some of the subjects intended to be addressed in the 
rulemakings include: 1) labeling; 2) notification of consignees and end 
users of product safety information for plasma derivative products; 3) 
notification of deferred donors; 4) requirements for donor suitability 
and testing; and 5) infectious agent clearance. These actions are 
intended to help ensure the continued safety of the Nation's blood 
supply.

Timetable:
________________________________________________________________________

Albumin (Human), Plasma Protein Fraction (Human) and Immune Globulin 
(Human); Rev. of Reqs.  Direct Final Rule 05/14/99 (64 FR 26282)  NPRM 
05/14/99 (64 FR 26344)  DFR: Confirmation in Part and Tech. Amendment 
03/14/00 (65 FR 13678)  Final Action 08/28/00 (65 FR 52016)

Current Good Manufacturing Practice for Blood and Blood Components; 
Blood Labeling Standards  NPRM 06/00/02

Gen. Reqs. for Blood, Blood Compon., and Plasma Derivatives; 
Notification of Deferred Donors  NPRM 08/19/99 (64 FR 45355)  Final 
Action 06/11/01 (66 FR 31165)

Infectious Agent Clearance  NPRM 01/00/03

Plasma Derivatives and Other Blood-Derived Products; Reqs. for Tracking 
and Notification  ANPRM 08/19/99 (64 FR 45383)  NPRM 06/00/02

Reqs. for Testing Human Blood Donors for Evid. of Infection Due to 
Communicable Disease Agents  NPRM 08/19/99 (64 FR 45340)  Final Action 
06/11/01 (66 FR 31146)

Rev. to the Requirements Applicable to Blood, Blood Components, and 
Source Plasma  Direct Final Rule 08/19/99 (64 FR 45366)  NPRM 08/19/99 
(64 FR 45375)  DFR: Confirmation in Part and Tech. Amendment 01/10/01 
(66 FR 1834)  Final Action 08/06/01 (66 FR 40886)

Suitability Reqs. for Whole Blood and Source Plasma Donors  NPRM 01/00/
03

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: None

Additional Information: See RIN 0910-AB76. CGMP for Blood and Blood 
Components; Blood Labeling Standards formerly listed under 0910-AB89

Agency Contact: Steven F. Falter, Director, Regulations and Policy 
Staff, 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: 301 594-1944
Email: [email protected]

RIN: 0910-AB26
_______________________________________________________________________




1019. 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.

Unfunded Mandates: Undetermined

Legal Authority: 21 USC 321; 21 USC 331; 21 USC 351; 21 USC 352; 21 USC 
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                            03/00/02

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Federalism:  Undetermined

Agency Contact: Brian L. Pendleton, 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, 1451 Rockville Pike, Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562
Email: [email protected]

RIN: 0910-AB34
_______________________________________________________________________




1020. EXPANDED ACCESS TO INVESTIGATIONAL THERAPIES

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

Unfunded Mandates: Undetermined

Legal Authority: 21 USC 360bbb

CFR Citation: 21 CFR 312

Legal Deadline: None

Abstract: The proposed rule would revise the investigational new drug 
regulations to clarify the conditions under which individual patients 
may receive investigational drugs for treatment use and to clarify the 
conditions under which a small group of patients may receive 
investigational drugs for treatment use under an access protocol.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/00/02

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Federalism:  Undetermined

Agency Contact: Joseph Griffin, Regulatory Counsel, Department of

[[Page 61579]]

Health and Human Services, Food and Drug Administration, (HFD-40), 
Center for Drug Evaluation and Research, 1451 Rockville Pike, Suite 
6021, Rockville, MD 20852
Phone: 301 594-6758
Fax: 301 594-5298

RIN: 0910-AB37
_______________________________________________________________________




1021. ELECTRONIC SUBMISSION OF POSTMARKETING SAFETY REPORTS

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

Unfunded Mandates: Undetermined

Legal Authority: 21 USC 216; 21 USC 355; 21 USC 371; 21 USC 374; 21 USC 
262; 21 USC 263; 21 USC 263a; 21 USC 264; 21 USC 300aa; 21 USC 321; 21 
USC 331; 21 USC 251 to 353

CFR Citation: 21 CFR 310; 21 CFR 314; 21 CFR 600

Legal Deadline: None

Abstract: The proposed rule would set forth requirements on the 
electronic submission of postmarketing safety reports using 
internationally accepted electronic data format, and electronic 
transmission standards.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

ANPRM                           11/05/98                    63 FR 59746
ANPRM Comment Period End        02/03/99
NPRM                            05/00/02

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Federalism:  Undetermined

Agency Contact: Audrey Thomas, Regulatory Policy Analyst, Office of 
Regulatory Policy, Department of Health and Human Services, Food and 
Drug Administration, Suite 3037 (HFD-7), Center for Drug Evaluation and 
Research, 1451 Rockville Pike, Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562

RIN: 0910-AB42
_______________________________________________________________________




1022. DISTINGUISHING MARKS FOR DRUG PRODUCTS CONTAINING INSULIN

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

Unfunded Mandates: Undetermined

Legal Authority: 21 USC 321; 21 USC 360gg to 360ss; 21 USC 371; 21 USC 
374; 21 USC 379e; 42 USC 216; 21 USC 331; 21 USC 351 to 353; 21 USC 
355; 21 USC 358; 21 USC 360; 21 USC 360b

CFR Citation: 21 CFR 201

Legal Deadline: None

Abstract: The proposed rule would set forth a new system of distinctive 
colors and marks to identify different types of insulin-containing drug 
products.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            04/00/02

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Federalism:  Undetermined

Agency Contact: Howard P. Muller, Office of Regulatory Policy, 
Department of Health and Human Services, Food and Drug Administration, 
Suite 3037 (HFD-7), Center for Drug Evaluation and Research, 1451 
Rockville Pike, Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562

RIN: 0910-AB43
_______________________________________________________________________




1023. PREGNANCY LABELING

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

Unfunded Mandates: Undetermined

Legal Authority: 21 USC 321; 21 USC 360gg to 360ss; 21 USC 371; 21 USC 
374; 21 USC 379e; 42 USC 216; 21 USC 331; 21 USC 351; 21 USC 352; 21 
USC 353; 21 USC 355; 21 USC 358; 21 USC 360; 21 USC 360b

CFR Citation: 21 CFR 201

Legal Deadline: None

Abstract: The proposed rule would revise the regulatory requirements 
for the pregnancy labeling subsection of the labeling requirements for 
human drugs and biologics.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/00/02

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Federalism:  Undetermined

Agency Contact: Virginia G. Beakes, 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, 1451 Rockville Pike, Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562
Email: [email protected]

RIN: 0910-AB44
_______________________________________________________________________




1024. POSITRON EMISSION TOMOGRAPHY DRUGS; CURRENT GOOD MANUFACTURING 
PRACTICE

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

Unfunded Mandates: Undetermined

Legal Authority: PL 105-115, sec 121

CFR Citation: 21 CFR 220

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

Abstract: Positron emission tomography (PET) is a medical imaging 
modality involving the use of a unique type of radiopharmaceutical 
drug. PET drugs are usually injected intravenously into patients for 
diagnostic purposes. Most PET drugs are produced using cyclotrons at 
locations that are in close proximity to the patients to whom the drugs 
are administered (e.g., in hospitals or academic institutions). Each 
PET drug is compounded under a physician's prescription and, due to the 
short half-lives of PET drugs, is administered to the patient within a 
few minutes or hours.
Under section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act 
(the Act) (21 U.S.C. 351(a)(2)(B)), a drug is adulterated if the 
methods used in, or the facilities or controls used for, its 
manufacture, processing, packing, or holding do not conform to or are 
not operated or administered in conformity with current good 
manufacturing practice (CGMP) to assure that the drug meets the 
requirements of the Act as to safety and has the identity and strength, 
and meets the quality and purity characteristics, that it purports or 
is represented to possess. FDA's CGMP requirements for drug products 
are set forth in 21 CFR parts 210 and 211.
On November 21, 1997, the President signed into law the Food and Drug 
Administration Modernization Act

[[Page 61580]]

(Modernization Act) (Pub. L. 105-115). Section 121 of the Modernization 
Act contains several provisions affecting the regulation of PET drugs. 
Section 121(c)(1)(A) of the Modernization Act directs FDA to establish, 
within two years after enactment, appropriate approval procedures and 
CGMP requirements for PET drugs. Section 121(c)(1)(B) directs FDA to 
consult with patient advocacy groups, professional associations, 
manufacturers, and other interested persons as the agency develops PET 
drug CGMP requirements and approval procedures. FDA's proposed rule on 
PET drug CGMP will be designed to reflect the unique nature of PET drug 
products.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            08/00/02

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Federalism:  Undetermined

Agency Contact: Brian L. Pendleton, 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, 1451 Rockville Pike, Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562
Email: [email protected]

RIN: 0910-AB63
_______________________________________________________________________




1025. CURRENT GOOD MANUFACTURING PRACTICE FOR MEDICATED FEEDS

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

Unfunded Mandates: Undetermined

Legal Authority: 21 USC 351; 21 USC 352; 21 USC 360b; 21 USC 371; 21 
USC 374

CFR Citation: 21 CFR 225

Legal Deadline: None

Abstract: This proposal is in response to a citizen petition request to 
merge the separate requirements of the current good manufacturing 
practice (CGMP) regulations, 21 CFR part 225 applicable to licensed and 
unlicensed feed manufacturing facilities, respectively. The merger 
would produce a single set of updated, streamlined CGMPs that apply to 
all medicated feed manufacturers. This consolidation of existing CGMPs 
would preserve and strengthen food safety, be more appropriate given 
the changing structure of the medicated feed industry, and enhance 
uniformity and enforcement.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/00/02

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Federalism:  Undetermined

Agency Contact: George Graber, Director, Division of Animal Feeds, 
Department of Health and Human Services, Food and Drug Administration, 
HFV-220, Center for Veterinary Medicine, 7500 Standish Place, 
Rockville, MD 20855
Phone: 301 827-6651
Email: [email protected]

RIN: 0910-AB70
_______________________________________________________________________




1026. FIXED-COMBINATION PRESCRIPTION AND OVER-THE-COUNTER DRUGS FOR 
HUMAN USE

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

Unfunded Mandates: Undetermined

Legal Authority: 21 USC 331; 21 USC 351; 21 USC 352; 21 USC 355; 21 USC 
360b; 21 USC 361; 21 USC 371

CFR Citation: 21 CFR 300.50; 21 CFR 330.10

Legal Deadline: None

Abstract: The proposed rule would amend 21 CFR 300.50 and 21 CFR 
330.10(a)(4)(iv), which state the conditions under which two or more 
drugs (for a prescription drug) or active ingredients (for an over-the-
counter drug) may be combined in a single dosage form. The proposed 
rule would state how this provision will apply to products derived from 
natural sources, including animal or botanical raw materials and 
traditional fermentation products.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            04/00/02

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Federalism:  Undetermined

Agency Contact: Brian L. Pendleton, 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, 1451 Rockville Pike, Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562
Email: [email protected]

RIN: 0910-AB79
_______________________________________________________________________




1027. REPACKAGING APPROVAL REQUIREMENTS

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

Unfunded Mandates: 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 314

Legal Deadline: None

Abstract: The proposed rule would set forth requirements for FDA prior 
approval of certain types of repackaging of approved drug products by 
persons who are not holders of approved applications for the products. 
The proposed rule would ensure that FDA approves changes to drug 
product containers and closure systems by both application holders and 
repackagers.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            08/00/02

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Federalism:  Undetermined

Agency Contact: Brian L. Pendleton, 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, 1451 Rockville Pike, Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562

[[Page 61581]]

Email: [email protected]

RIN: 0910-AB81
_______________________________________________________________________




1028. CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKING, OR 
HOLDING DIETARY INGREDIENTS AND DIETARY SUPPLEMENTS

 Regulatory Plan: This entry is Seq. No. 29 in part II of this issue of 
the Federal Register.

RIN: 0910-AB88
_______________________________________________________________________




1029. SUBMISSION IN ELECTRONIC FORMAT OF CERTAIN LABELING INFORMATION

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

Unfunded Mandates: Undetermined

Legal Authority: 21 USC 321; 21 USC 331; 21 USC 350; 21 USC 351; 21 USC 
353; 21 USC 355; 21 USC 371; 21 USC 374; 21 USC 379e; ...

CFR Citation: 21 CFR 314.50; 21 CFR 314.81; 21 CFR 314.94

Legal Deadline: None

Abstract: The Food and Drug Administration is proposing to amend its 
regulations governing the format in which certain labeling in new drug 
applications, abbreviated new drug applications, certain biological 
license applications, supplements, and annual reports is required to be 
submitted. The proposal would require that certain labeing content 
described under sections 201.56 and 201.57 be submitted to FDA in 
electronic format.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            03/00/02

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected: No

Government Levels Affected: Undetermined

Federalism:  Undetermined

Agency Contact: Andrea C. Masciale, 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, 1451 Rockville Pike, Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562

RIN: 0910-AB91
_______________________________________________________________________




1030. FEES RELATING TO DRUGS; WAIVER AND REDUCTION OF FEES

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

Unfunded Mandates: Undetermined

Legal Authority: 21 USC 379g; 21 USC 379h

CFR Citation: Not Yet Determined

Legal Deadline: None

Abstract: Sections 735 and 736 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. sections 379g and 379h) require FDA to assess and 
collect fees related to human drug applications. Section 736(d) of the 
Act (21 U.S.C. 379h(d)) authorizes the agency to grant a waiver or 
reduction of such fees in certain circumstances. This proposed rule 
would establish FDA's criteria for determining when to grant a waiver 
or reduction of fees.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/00/02

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected: No

Government Levels Affected: Undetermined

Federalism:  Undetermined

Agency Contact: Paul C. Varki, 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, 1451 Rockville Pike, Rockville, MD 20852
Phone: 301 594-2041
Email: [email protected]

RIN: 0910-AB92
_______________________________________________________________________




1031. PERIODIC TESTING FOR CERTAIN HUMAN DRUG, VETERINARY DRUG, AND 
BIOLOGICAL PRODUCT FINAL SPECIFICATIONS

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

Unfunded Mandates: Undetermined

Legal Authority: 21 USC 321; 21 USC 351; 21 USC 352; 21 USC 355; 21 USC 
360(b); 21 USC 371; 21 USC 374

CFR Citation: 21 CFR 211.165; 21 CFR 314; 21 CFR 514; 21 CFR 601; 21 
CFR 610

Legal Deadline: None

Abstract: The proposed rule requests comments on when certain finished 
product laboratory tests to determine satisfactory conformance to final 
specifications for new human drug, animal drug, and biological products 
may be performed on a periodic basis.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/00/02

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected: No

Government Levels Affected: Undetermined

Federalism:  Undetermined

Agency Contact: Carol Drew, 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, 1451 Rockville Pike, Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562

RIN: 0910-AB93
_______________________________________________________________________




1032. REQUIREMENTS PERTAINING TO SAMPLING SERVICES AND PRIVATE 
LABORATORIES USED IN CONNECTION WITH IMPORTED FOOD

Priority: Routine and Frequent

Legal Authority: 21 USC 331; 21 USC 333; 21 USC 334; 21 USC 335b; 21 
USC 335c; 21 USC 342; 21 USC 343; 21 USC 351; 21 USC 352; 21 USC 361; 
21 USC 362; 21 USC 371; 21 USC 372; 21 USC 374; 21 USC 376; 21 USC 381

CFR Citation: 21 CFR 59

Legal Deadline: None

Abstract: The proposed rule would establish requirements for importers 
and other persons who use sampling services and private laboratories in 
connection with imported food. For example, the proposal would pertain 
to persons who use sample collection services and private laboratories 
and would describe some responsibilities for such persons, sample 
collection services, and private laboratories. These responsibilities 
might include recordkeeping requirements to ensure

[[Page 61582]]

that the correct sample is collected and analyzed, and a notification 
requirement if a person intends to use a private laboratory in 
connection with imported food. The proposed rule is intended to help 
insure the integrity and scientific validity of data and results 
submitted to FDA.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            05/00/02

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected: No

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, Planning and Legislation, 5600 Fishers Lane, 
Rockville, MD 20857
Phone: 301 827-0587
Fax: 301 827-4774
Email: [email protected]

RIN: 0910-AB96
_______________________________________________________________________




1033. MEDICAL DEVICES, MEDICAL DEVICE ESTABLISHMENT REGISTRATION AND 
LISTING REQUIREMENTS; AMENDMENT

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

Unfunded Mandates: Undetermined

Legal Authority: 21 USC 331; 21 USC 351; 21 USC 352; 21 USC 360; 21 USC 
360c; 21 USC 360e; 21 USC 360i; 21 USC 360j; 21 USC 371; 21 USC 374

CFR Citation: Not Yet Determined

Legal Deadline: None

Abstract: FDA is considering revising its present establishment 
registration and device listing regulations. More particularly, FDA is 
considering whether to: (1) merge establishment registration and device 
listing into a single process; (2) require the electronic submission of 
the establishment registration and device listing information to FDA 
through the Internet; (3) require use of a firm identification number 
that would link registration and listing information for all 
establishments operated by the same firm; (4) amend time frames for 
providing and updating registration and listing data; and (5) require 
notification of transfer of ownership for all premarket applications.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/00/02

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: None

Agency Contact: Bryan H. Benesch, Special Assistant to the Director, 
Office of Compliance, Department of Health and Human Services, Food and 
Drug Administration, HFZ-300, Center for Devices and Radiological 
Health, 2094 Gaither Road, Rockville, MD 20850
Phone: 301 549-4699
Fax: 301 594-4715
Email: [email protected]

RIN: 0910-AB99
_______________________________________________________________________




1034. 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; 21 USC 360j; 21 USC 360k; 21 USC 361; 21 USC 371; 21 
USC 379e; 42 USC 262

CFR Citation: 21 CFR 70.3; 21 CFR 71.1; 21 CFR 170.3; 21 CFR 171.1; 21 
CFR 312.3; 21 CFR 312.56; 21 CFR 510.3; 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 has or may have falsified 
data in the course of proposing, designing, performing, recording, 
supervising, or reviewing research, or in reporting research results.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            02/00/02

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: None

Agency Contact: Christine Rogers, Regulatory Counsel, Department of 
Health and Human Services, Food and Drug Administration, Suite 3059 
(HFD-7), Center for Drug Evaluation and Research, 1451 Rockville Pike, 
Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562

RIN: 0910-AC02
_______________________________________________________________________




1035. STATUS REPORTS OF DISTRIBUTION AND USE INFORMATION FOR 
ANTIMICROBIAL ANIMAL DRUG PRODUCTS USED IN FOOD-PRODUCING ANIMALS

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

Unfunded Mandates: Undetermined

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

CFR Citation: 21 CFR 510.300

Legal Deadline: None

Abstract: After approving a new animal drug application, the Food and 
Drug Administration (FDA) requires the sponsor to submit adverse 
experience and use information on the product. The currently submitted 
distribution data are insufficient to provide the use information 
needed by FDA. Because of concern about the effect of the use of 
antimicrobial drugs in food-producing animals on the development rate 
and extent of resistance in human pathogens, FDA published a document 
describing a proposed framework for evaluating and protecting human 
health. The Framework Document describes the need for more detailed 
drug distribution information to permit the evaluation of a correlation 
between changes in resistance and the use of antimicrobial drugs in 
food-producing animals. The regulatory proposal would require the 
reporting of the total number of distributed units of each size, 
strength, or potency (distribution data or quantity marketed data) and 
provide FDA with the more detailed information needed to assess the 
correlation between resistance in human pathogens and the use of 
antimicrobial drugs in food-producing animals.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            05/00/02

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected: Businesses

Government Levels Affected: None

Federalism:  Undetermined

[[Page 61583]]

Agency Contact: William Keller, Division Director, Division of 
Surveillance, Department of Health and Human Services, Food and Drug 
Administration, (HFV-210), Center for Veterinary Medicine, 7500 
Standish Place, Rockville, MD 20855
Phone: 301 827-6642

RIN: 0910-AC04
_______________________________________________________________________




1036. LABELING DIETARY SUPPLEMENTS FOR WOMEN WHO ARE OR MAY BECOME 
PREGNANT

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

Unfunded Mandates: Undetermined

Legal Authority: 21 USC 321(n); 21 USC 342(f); 21 USC 343(a)(1); 21 USC 
343(r)(6); 21 USC 371(a)

CFR Citation: Not Yet Determined

Legal Deadline: None

Abstract: The Food and Drug Administration (FDA) is proposing to 
require manufacturers to label their dietary supplements with a caution 
statement for women who are or may become pregnant unless there is 
evidence demonstrating that use in pregnancy is safe. FDA is including 
in this proposal a list of products that would not require this caution 
statement, as well as a petition process by which a product may be 
exempted from bearing the caution statement. FDA is also proposing to 
require manufacturers of dietary supplements that bear a claim about an 
effect on a condition associated with pregnancy to maintain and permit 
FDA inspection of certain records. FDA is proposing this rule because 
of the special safety concerns associated with use of any product 
during pregnancy.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            02/00/02

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Federalism:  Undetermined

Agency Contact: Brian L. Pendleton, 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, 1451 Rockville Pike, Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562
Email: [email protected]

RIN: 0910-AC09
_______________________________________________________________________




1037. REGULATION OF CARCINOGENIC COMPOUNDS USED IN FOOD-PRODUCING 
ANIMALS; DEFINITION OF ``NO RESIDUE''

Priority: Substantive, Nonsignificant

Legal Authority: 21 USC 321; 21 USC 331; 21 USC 342; 21 USC 343; 21 USC 
348; 21 USC 351 to 353; 21 USC 360b; 21 USC 371

CFR Citation: 21 CFR 500.82; 21 CFR 500.84; 21 CFR 500.88

Legal Deadline: None

Abstract: The Food and Drug Administration (FDA) is proposing to amend 
its regulations relating to the operational definition of the term ``no 
residue.'' The definition is used in determining whether any residue of 
carcinogenic compounds used in food-producing animals would ``be found 
in food produced from those animals under conditions of use reasonably 
certain to be followed in practice'' (21 CFR 500.80(a)). Under the 
current operational definition of no residue, it is possible for a 
residue detected by a method approved by FDA to be considered ``no 
residue.'' FDA is revising its regulations to make them consistent with 
a 1995 Department of Justice opinion regarding this definition. The 
proposed changes would revise the definition of ``no residue'' to mean 
that no residue is detected with an approved regulatory method. FDA 
would propose several conditions that sponsors of carcinogenic 
compounds must satisfy with respect to the sponsors' proposed 
regulatory methods.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/00/01

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Steven Brynes, Regulatory Scientist, Department of 
Health and Human Services, Food and Drug Administration, HFV-151, 
Center for Veterinary Medicine, 7500 Standish Place, Rockville, MD 
20855
Phone: 301 827-6975
Email: [email protected]

RIN: 0910-AC13
_______________________________________________________________________




1038. CONTROL OF SALMONELLA ENTERITIDIS IN SHELL EGGS DURING PRODUCTION 
AND RETAIL

 Regulatory Plan: This entry is Seq. No. 30 in part II of this issue of 
the Federal Register.

RIN: 0910-AC14
_______________________________________________________________________




1039. ALUMINUM IN LARGE AND SMALL VOLUME PARENTERALS USED IN TOTAL 
PARENTERAL NUTRITION

Priority: Other Significant

Legal Authority: 21 USC 352; 21 USC 321(n); 21 USC 371(a); 21 USC 355; 
21 CFR 201.51; 21 CFR 201.100; 21 CFR 314.125

CFR Citation: 21 CFR 201.323(c)

Legal Deadline: None

Abstract: The proposed rule would revise 21 CFR 323(c) to permit small 
volume parenterals and pharmacy bulk packages that contain less than 25 
ug/L of aluminum to state ``contains less than 25ug/L'' rather than the 
exact amount of aluminum.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            03/00/02

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Christine Rogers, Regulatory Counsel, Department of 
Health and Human Services, Food and Drug Administration, Suite 3059 
(HFD-7), Center for Drug Evaluation and Research, 1451 Rockville Pike, 
Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562

RIN: 0910-AC18
_______________________________________________________________________




1040. USE OF MATERIALS DERIVED FROM RUMINANT ANIMALS IN FDA REGULATED 
PRODUCTS

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

Legal Authority: Not Yet Determined

CFR Citation: Not Yet Determined

[[Page 61584]]

Legal Deadline: None

Abstract: The U.S. Department of Agriculture's Animal and Plant Health 
Inspection Service maintains, by regulation in 9 CFR 94.18(a), a list 
of countries: (1) where bovine spongiform encephalopathy (BSE) exists; 
and (2) that present an undue risk of introducing BSE into the United 
States. This proposed rule would restrict, in FDA regulated products, 
the use of most materials derived from ruminant animals born, raised, 
or slaughtered in a country listed in 9 CFR 94.18(a). In addition, 
there would be a waiver provision that could be used under appropriate 
criteria.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/00/02

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Federalism:  Undetermined

Agency Contact: Andrea C. Masciale, 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, 1451 Rockville Pike, Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562

RIN: 0910-AC19
_______________________________________________________________________




1041. POSTMARKETING REPORTS OF SUBSTANDARD OR INEFFECTIVE BULK 
INGREDIENTS AND BULK INGREDIENTS FROM UNAPPROVED SOURCES

Priority: Info./Admin./Other

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: Not Yet Determined

Legal Deadline: None

Abstract: The proposed rule would address reporting and other issues 
relating to the importation or receipt of bulk ingredients that are 
substandard, ineffective, or come from unapproved sources. The proposal 
is intended to enhance FDA's ability to help ensure that human drug 
products have the strength, quality, and purity appropriate for an 
approved human drug product.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/00/02

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: None

Federalism:  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, Planning and Legislation, 5600 Fishers Lane, 
Rockville, MD 20857
Phone: 301 827-0587
Fax: 301 827-4774
Email: [email protected]

RIN: 0910-AC20
_______________________________________________________________________




1042.  EXCEPTION FROM GENERAL REQUIREMENTS FOR INFORMED 
CONSENT; REQUEST FOR COMMENTS AND INFORMATION

 Regulatory Plan: This entry is Seq. No. 31 in part II of this issue of 
the Federal Register.

RIN: 0910-AC25
_______________________________________________________________________




1043.  BAR CODE LABEL REQUIREMENTS FOR HUMAN DRUG PRODUCTS

 Regulatory Plan: This entry is Seq. No. 32 in part II of this issue of 
the Federal Register.

RIN: 0910-AC26
_______________________________________________________________________




1044.  PROMOTION AND CHARGING FOR INVESTIGATIONAL DRUGS

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

Legal Authority: 21 USC 360bbb

CFR Citation: 21 CFR 312

Legal Deadline: None

Abstract: The proposed rule would clarify the criteria under which 
sponsors can recover costs for investigational drugs, create one new 
category of investigational use for which sponsors may be able to 
recover cost, and clarify the types of costs that can be recovered when 
charging for an investigational drug.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/00/02

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Federalism:  Undetermined

Agency Contact: Joseph Griffin, Regulatory Counsel, Department of 
Health and Human Services, Food and Drug Administration, (HFD-40), 
Center for Drug Evaluation and Research, 1451 Rockville Pike, Suite 
6021, Rockville, MD 20852
Phone: 301 594-6758
Fax: 301 594-5298

RIN: 0910-AC27

[[Page 61585]]

_______________________________________________________________________


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


Food and Drug Administration (FDA)



_______________________________________________________________________




1045. NEW ANIMAL DRUG APPROVAL PROCESS; IMPLEMENTATION OF TITLE I OF THE 
GENERIC ANIMAL DRUG AND PATENT TERM RESTORATION ACT (GADPTRA)

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

Legal Authority: 21 USC 321; 21 USC 351; 21 USC 352; 21 USC 360b; 21 
USC 371; 21 USC 379e; 21 USC 381

CFR Citation: 21 CFR 514

Legal Deadline: Final, Statutory, November 16, 1989, The deadline 
applies to the GADPTRA sections. There is no deadline relating to the 
other sections.

Abstract: On December 17, 1991, the Agency published a proposed 
revision of the existing regulations that is consistent with the 
current procedural regulations for human drugs, where appropriate. The 
New Animal Drug Application (NADA) revisions articulate general 
requirements in regulations containing performance standards and would 
complement these regulations through detailed guidance on, among other 
matters, appropriate ways of meeting requirements for submission of 
chemistry, pharmacology, and statistical data that would better address 
the intricate scientific issues involved. A separate proposed rule for 
reporting requirements for marketed animal drugs also was published on 
that date. The agency intends to repropose the NADA proposed rule to 
incorporate some recent changes in procedure. The NADA revisions are 
expected to include regulations to implement the provisions of the 
Animal Drug Availability Act of 1996, specifically the definition of 
flexible labeling, and implement parts of the President's National 
Performance Report ``Reinventing the Regulation of Animal Drugs,'' May 
1996. In the reinventing regulations report, FDA proposed to revise its 
regulations to reflect numerous new process changes and programs that 
will maintain the safety and effectiveness of new animal drugs and 
enable a more streamlined animal drug application review and approval 
process which will result in less regulatory burden upon industry and 
FDA. The Agency also proposes to amend its regulations to implement 
title I of the Generic Animal Drug and Patent Term Restoration Act, 
which established new standards for marketing approval of generic 
copies of animal drugs approved after 1962.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

ANPRM                           11/21/96                    61 FR 59209
ANPRM Comment Period End        01/21/97
New Animal Drug Approval Process  NPRM 12/17/91 (56 FR 65544)  NPRM To 
Be Determined

Records and Reports Concerning Experience with Approved New Animal 
Drugs  NPRM 12/17/91 (56 FR 65581)  Final Action 01/00/02

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: None

Additional Information: For information concerning reporting 
requirements for marketed animal drugs, contact William C. Keller, 
Director, Division of Surveillance, Center for Veterinary Medicine, 
Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855, 
301 827-6642.
For further information concerning generic animal drugs, contact Lonnie 
W. Luther, Chief, Quality Assurance Support Team, Center for Veterinary 
Medicine, Food and Drug Administration, 7500 Standish Place, Rockville, 
MD 20855, 301 827-0209.

Agency Contact: Claire Lathers, Director, Office of New Animal Drug 
Evaluation, Department of Health and Human Services, Food and Drug 
Administration, HFV-100, Center for Veterinary Medicine, 7500 Standish 
Place, Rockville, MD 20855
Phone: 301 827-1796

RIN: 0910-AA02
_______________________________________________________________________




1046. CURRENT GOOD MANUFACTURING PRACTICE; AMENDMENT OF CERTAIN 
REQUIREMENTS FOR FINISHED PHARMACEUTICALS

Priority: Substantive, Nonsignificant

Legal Authority: 21 USC 321; 21 USC 351; 21 USC 352; 21 USC 355; 21 USC 
360b; 21 USC 371; 21 USC 374

CFR Citation: 21 CFR 210.3; 21 CFR 211.113; 21 CFR 211.160; 21 CFR 
211.165; 21 CFR 211.166; 21 CFR 211.180; 21 CFR 211.192; 21 CFR 
211.220; 21 CFR 211.222; 21 CFR 211.240; 21 CFR 211.22; 21 CFR 211.68; 
21 CFR 211.82; 21 CFR 211.84; 21 CFR 211.101; 21 CFR 211.103; 21 CFR 
211.110; 21 CFR 211.111; ...

Legal Deadline: None

Abstract: FDA is finalizing revisions to the current good manufacturing 
practice (CGMP) regulations at 21 CFR parts 210 and 211 regarding 
finished pharmaceuticals. The new regulations will codify certain 
current agency policies and current industry practices. The rule will, 
among other things, create or clarify requirements for process and 
methods validation, appropriate laboratory testing procedures, and 
protection against contamination. The rule is designed to update the 
CGMP regulations in response to technological changes and the agency's 
experience with the regulations.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            05/03/96                    61 FR 20104
NPRM Comment Period End         09/30/96
Final Action                    07/00/02

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: None

Agency Contact: Howard P. Muller, Office of Regulatory Policy, 
Department of Health and Human Services, Food and Drug Administration, 
Suite 3037 (HFD-7), Center for Drug Evaluation and Research, 1451 
Rockville Pike, Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562

RIN: 0910-AA45
_______________________________________________________________________




1047. BIOAVAILABILITY AND BIOEQUIVALENCE REQUIREMENTS

Priority: Substantive, Nonsignificant

Legal Authority: 21 USC 321; 21 USC 351; 21 USC 352; 21 USC 355; 21 USC 
371

CFR Citation: 21 CFR 320

Legal Deadline: None

Abstract: The final rule revises and clarifies certain sections of 
parts 314 and 320 and eliminates duplication and inconsistencies.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            11/19/98                    63 FR 64222

[[Page 61586]]

NPRM Comment Period End         02/02/99
Final Action                    05/00/02

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Christine Rogers, Regulatory Counsel, Department of 
Health and Human Services, Food and Drug Administration, Suite 3059 
(HFD-7), Center for Drug Evaluation and Research, 1451 Rockville Pike, 
Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562

RIN: 0910-AA51
_______________________________________________________________________




1048. DETERMINATION THAT INFORMED CONSENT IS INFEASIBLE OR IS CONTRARY 
TO THE BEST INTEREST OF RECIPIENTS

Priority: Other Significant

Legal Authority: 21 USC 321; 42 USC 241; 42 USC 262; 21 USC 352; 21 USC 
353; 21 USC 355; 21 USC 360; 21 USC 371; 42 USC 216; 21 USC 346; 21 USC 
346a; 21 USC 348; 21 USC 360c; 21 USC 360d; 21 USC 360e; 21 USC 360f; 
21 USC 360h; 21 USC 360i; 21 USC 360j; 21 USC 379e; 21 USC 381; 42 USC 
263b; 42 USC 263e; 42 USC 263f; 42 USC 263g; 42 USC 263h; 42 USC 263i; 
42 USC 263j; 42 USC 263k; 42 USC 263l; 42 USC 263m; 42 USC 263n; 42 USC 
263c; 42 USC 263d

CFR Citation: 21 CFR 50; 21 CFR 312

Legal Deadline: None

Abstract: The Food and Drug Administration is planning to publish a 
final rule that would finalize its 1999 interim final rule (64 FR 
54180) that established strengthened criteria and standards for the 
President to apply in making a determination that informed consent is 
not feasible or is contrary to the best interest of military personnel 
engaged in specific military operations. Under the Strom Thurmond 
National Defense Authorization Act for Fiscal Year 1999, the President 
is authorized to waive the Federal Food, Drug, and Cosmetic Act's 
informed consent requirements in military operations, if the President 
finds that obtaining consent is infeasible or contrary to the best 
interests of recipients and on an additional ground that obtaining 
consent is contrary to national security interests.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              10/05/99                    64 FR 54180
Final Action                    04/00/02

Regulatory Flexibility Analysis Required: No

Government Levels Affected: Federal

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, Planning and Legislation, 5600 Fishers Lane, 
Rockville, MD 20857
Phone: 301 827-0587
Fax: 301 827-4774
Email: [email protected]

RIN: 0910-AA89
_______________________________________________________________________




1049. LABELING FOR HUMAN PRESCRIPTION DRUGS; REVISED FORMAT

 Regulatory Plan: This entry is Seq. No. 33 in part II of this issue of 
the Federal Register.

RIN: 0910-AA94
_______________________________________________________________________




1050. CURRENT GOOD MANUFACTURING PRACTICE; REVISION OF CERTAIN LABELING 
CONTROLS

Priority: Substantive, Nonsignificant

Legal Authority: 21 USC 321; 21 USC 351; 21 USC 352; 21 USC 355; 21 USC 
360b; 21 USC 371; 21 USC 374

CFR Citation: 21 CFR 210; 21 CFR 211

Legal Deadline: None

Abstract: The final rule will amend the labeling control provisions for 
gang-printed or cut labeling in the current good manufacturing practice 
regulations for drug products (21 CFR parts 210 and 211) to make the 
provisions less burdensome while still reducing the frequency of drug 
product mislabeling and drug product recalls associated with cut 
labeling.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            07/29/97                    62 FR 40489
NPRM Comment Period End         10/27/97
Final Action                    05/00/02

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: None

Agency Contact: Howard P. Muller, Office of Regulatory Policy, 
Department of Health and Human Services, Food and Drug Administration, 
Suite 3037 (HFD-7), Center for Drug Evaluation and Research, 1451 
Rockville Pike, Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562

RIN: 0910-AA98
_______________________________________________________________________




1051. USE OF OZONE-DEPLETING SUBSTANCES

Priority: Other Significant

Legal Authority: 15 USC 402; 21 USC 352; 21 USC 355; 21 USC 360b; 21 
USC 361; 21 USC 371; 15 USC 409; 21 USC 321; 21 USC 331; 21 USC 335; 21 
USC 342; 21 USC 346a; 21 USC 348; 21 USC 351

CFR Citation: 21 CFR 2

Legal Deadline: None

Abstract: FDA is amending the regulation that permits the use of ozone-
depleting substances in particular circumstances to set the standard 
FDA will use to determine when the use of ozone-depleting substances 
(ODS) is no longer essential under the Clean Air Act (CAA) and set a 
new standard to determine when a new essential-use designation should 
be granted after the effective date of the rule. FDA is also amending 
the regulations to better conform to other statutes and regulations 
relating to ozone-depleting substances to eliminate potential confusion 
and conflicts. FDA is eliminating out-of-date transitional provisions 
and making other nonsubstantive housekeeping changes to its regulations 
on ozone-depleting substances. The intended effect of the rule is to 
protect the health and safety of medical product users while complying 
with the CAA and the Montreal Protocol.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

ANPRM                           03/06/97                    62 FR 10242
ANPRM Comment Period End        05/05/97
NPRM                            09/01/99                    64 FR 47719
NPRM Comment Period End         11/30/99
Final Action                    02/00/02

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

[[Page 61587]]

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, 1451 Rockville Pike, Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562
Email: [email protected]

RIN: 0910-AA99
_______________________________________________________________________




1052. EXPORTS; NOTIFICATION AND RECORDKEEPING REQUIREMENTS

Priority: Routine and Frequent

Legal Authority: 15 USC 1453 to 1455; 21 USC 382; 21 USC 393; 42 USC 
216; 42 USC 241; 42 USC 243; 42 USC 262; 21 USC 321; 21 USC 343; 21 USC 
352; 21 USC 355; 21 USC 360b; 21 USC 362; 21 USC 371; 21 USC 381

CFR Citation: 21 CFR 1.101

Legal Deadline: None

Abstract: The final rule would establish the notification recordkeeping 
requirements for persons exporting human drugs, animal drugs, 
biological products, and devices under the FDA Export Reform and 
Enhancement Act.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            04/02/99                    64 FR 15944
Extension                       06/17/99                    64 FR 32442
NPRM Comment Period End         07/16/99
Final Action                    12/00/01

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, Planning and Legislation, 5600 Fishers Lane, 
Rockville, MD 20857
Phone: 301 827-0587
Fax: 301 827-4774
Email: [email protected]

RIN: 0910-AB16
_______________________________________________________________________




1053. FOREIGN ESTABLISHMENT REGISTRATION AND LISTING

 Regulatory Plan: This entry is Seq. No. 34 in part II of this issue of 
the Federal Register.

RIN: 0910-AB21
_______________________________________________________________________




1054. FDA EXPORT REFORM AND ENHANCEMENT ACT OF 1996; REPORTING AND 
RECORDKEEPING REQUIREMENTS FOR UNAPPROVED OR VIOLATIVE PRODUCTS IMPORTED 
FOR FURTHER PROCESSING OR INCORPORATION AND LATER EXPORT

Priority: Substantive, Nonsignificant

Legal Authority: 15 USC 1453 to 1455; 21 USC 381; 21 USC 382; 21 USC 
393; 42 USC 216; 21 USC 321; 21 USC 343; 21 USC 352; 21 USC 355; 21 USC 
360b; 21 USC 362; 21 USC 371; 21 USC 374

CFR Citation: 21 CFR 1.84

Legal Deadline: None

Abstract: The final rule would establish reporting and recordkeeping 
requirements to implement sections 801(d)(3) and 801(d)(4) of the 
Federal Food, Drug, and Cosmetic Act (the Act) as amended by the Food 
and Drug Administration (FDA) Export Reform and Enhancement Act of 
1996. Section 801(d)(3) of the Act provides that, under prescribed 
conditions, drug and device components, food and color additives, and 
dietary supplements may be imported if they are to be further processed 
or incorporated into products that are to be exported from the United 
States in accordance with sections 801(e) or 802 of the Act or section 
351(h) of the Public Health Service (PHS) Act. Section 801(d)(4) of the 
Act provides that blood, blood components, source plasma, or source 
leukocytes, or a component, accessory, or part thereof, may not be 
imported under section 801(d)(3) of the Act unless the importation 
complies with section 351(a) of the PHS Act or FDA permits the 
importation under FDA-determined appropriate circumstances and 
conditions. Additionally, section 801(d)(4) of the Act prohibits the 
importation of tissue or a component or part of tissue under section 
801(d)(3) of the Act unless the importation complies with section 361 
of the PHS Act.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            11/24/98                    63 FR 64930
NPRM Comment Period End         02/08/99
Final Action                    05/00/02

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, Planning and Legislation, 5600 Fishers Lane, 
Rockville, MD 20857
Phone: 301 827-0587
Fax: 301 827-4774
Email: [email protected]

RIN: 0910-AB24
_______________________________________________________________________




1055. ANTIBIOTIC DRUG APPROVAL AND EXCLUSIVITY

Priority: Substantive, Nonsignificant

Unfunded Mandates: Undetermined

Legal Authority: PL 105-115, sec 125

CFR Citation: 21 CFR 314

Legal Deadline: None

Abstract: The final rule would implement the incorporation of 
antibiotics, which were formerly regulated under authority of section 
507 of the Federal Food, Drug, and Cosmetic Act, into the new drug 
regulatory scheme under section 505 of the Act. The regulation will 
describe which antibiotics are excepted under section 125(d) of the 
Food and Drug Administration Modernization Act of 1997 from certain 
provisions in section 505, including the exclusivity provisions under 
sections 505(c) and 505(j) of the Act.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            01/24/00                     65 FR 3623
NPRM Comment Period End         04/24/00
Final Action                    04/00/02

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Paul C. Varki, 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, 1451 Rockville Pike, Rockville, MD 20852
Phone: 301 594-2041
Email: [email protected]

RIN: 0910-AB33

[[Page 61588]]

_______________________________________________________________________




1056. AMENDMENT OF REGULATIONS REGARDING CERTAIN LABEL STATEMENTS ON 
PRESCRIPTION DRUGS

Priority: Substantive, Nonsignificant

Legal Authority: PL 105-115, sec 126

CFR Citation: 21 CFR 201; 21 CFR 250; 21 CFR 310; 21 CFR 329; 21 CFR 
361; 21 CFR 369; 21 CFR 290

Legal Deadline: None

Abstract: This final rule revises 21 CFR parts 10, 201, 250, 310, 329, 
361, 606, and 610 by removing the requirement that prescription drugs 
be labeled ``Caution: Federal law prohibits dispensing without 
prescription'' and substituting a requirement that prescription drugs 
be labeled ``Rx only.'' The rule also revises 21 CFR parts 201, 329, 
and 369 by removing the requirement that certain habit-forming drugs 
bear the statement ``Warning--May be habit forming.'' The rule also 
revises 21 CFR part 290 to clarify that drugs that are controlled 
substances under the Federal Controlled Substances Act are prescription 
drugs.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            04/21/00                    65 FR 21378
Final Action                    02/00/02

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Christine Rogers, Regulatory Counsel, Department of 
Health and Human Services, Food and Drug Administration, Suite 3059 
(HFD-7), Center for Drug Evaluation and Research, 1451 Rockville Pike, 
Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562

RIN: 0910-AB39
_______________________________________________________________________




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

Priority: Other Significant

Legal Authority: 21 USC 356a

CFR Citation: 21 CFR 514.8

Legal Deadline: None

Abstract: Section 116 of the Food and Drug Administration Modernization 
Act of 1997 added a new section to the Federal Food, Drug, and Cosmetic 
Act that sets forth categories for the reporting of manufacturing 
changes to a drug product (21 U.S.C. 356a). These categories are based 
on the potential of the change to adversely affect the identity, 
strength, quality, purity, and potency of the drug as they may relate 
to the safety and effectiveness of the drug. The rulemaking will 
establish the procedures for determining what information the agency 
would require before drugs manufactured subject to these changes may be 
distributed. The Center for Veterinary Medicine is amending the 
regulations regarding supplementary new animal drug regulations to 
incorporate the requirements of section 116.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            10/01/99                    64 FR 53281
Final Rule                      05/00/02

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: Undetermined

Federalism:  Undetermined

Agency Contact: William Marnane, Director, Division of Manufacturing 
Technologies, Department of Health and Human Services, Food and Drug 
Administration, HFV-140, Center for Veterinary Medicine, 7500 Standish 
Place, Rockville, MD 20855
Phone: 301 827-6966

RIN: 0910-AB49
_______________________________________________________________________




1058. REVISIONS TO THE GENERAL SAFETY REQUIREMENTS FOR BIOLOGICAL 
PRODUCTS; DIRECT FINAL RULE

Priority: Substantive, Nonsignificant

Legal Authority: 42 USC 351

CFR Citation: 21 CFR 610.11(g)

Legal Deadline: None

Abstract: The Food and Drug Administration (FDA) issued a direct final 
rule and companion proposed rule to amend the biologics regulations by 
adding ``cellular therapy products'' to the list of products excepted 
from the general safety test (GST) and by adding an administrative 
procedure for obtaining an exemption from the GST requirements for 
other biological products. Because the agency received significant 
adverse comment on the administrative procedure portion of the direct 
final rule, FDA withdrew that portion of the rule and confirmed the 
remaining portion. FDA intends to finalize the companion proposed rule 
to respond to the significant adverse comment on the administrative 
procedure portion of the rule. FDA is taking this action because the 
GST may not be relevant or necessary for all biological products, 
including cellular therapy products, currently in various stages of 
development. This action is part of FDA's continuing effort to achieve 
the objectives of the ``Reinventing Government'' initiative, and is 
intended to reduce the burden of unnecessary regulations on biological 
products without diminishing the protection of the public health.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Direct Final Rule               04/20/98                    63 FR 19399
Proposed Rule - Companion 
Document to Direct Final Rule   04/20/98                    63 FR 19431
Direct Final Rule Confirmation 
in Part                         08/05/98                    63 FR 41718
Direct Final Rule Withdrawn in 
Part                            08/05/98                    63 FR 41718
Final Action                    05/00/02

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Stephen M. Ripley, Team Leader, 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

RIN: 0910-AB51
_______________________________________________________________________




1059. DISCONTINUATION OF A LIFESAVING PRODUCT

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

Unfunded Mandates: Undetermined

Legal Authority: 21 USC 356(c)

CFR Citation: 21 CFR 314

Legal Deadline: None

Abstract: Section 131 of the Food and Drug Administration Modernization 
Act of 1997 (Pub. L. 105-115) added section 506C to the Food, Drug, and 
Cosmetic Act (21 U.S.C. 356c). This proposed

[[Page 61589]]

rule would set forth requirements on issues related to the 
implementation of section 131, which requires that the sole 
manufacturer of certain drug products notify the Secretary of the 
discontinuance of the manufacture of the product at least six months 
prior to the discontinuance of the drug.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            11/07/00                    65 FR 66665
Final Action                    02/00/02

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Federalism:  Undetermined

Agency Contact: Mitchell Weitzman, 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, 1451 Rockville Pike, Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562

RIN: 0910-AB60
_______________________________________________________________________




1060. SUPPLEMENTS AND OTHER CHANGES TO AN APPROVED APPLICATION

Priority: Other Significant

Legal Authority: 21 USC 356a

CFR Citation: 21 CFR 314

Legal Deadline: None

Abstract: Section 116 of the Food and Drug Administration Modernization 
Act of 1997 (Pub. L. 105-115) added section 506A to the Food, Drug, and 
Cosmetic Act (21 U.S.C. 356a). Pursuant to section 116, the rulemaking 
will revise current procedures for approving manufacturing changes and 
generally classify such changes into four categories. Major 
manufacturing changes, which are of a type determined by the Secretary 
to have a substantial potential to adversely affect the identity, 
strength, quality, purity, and potency of the drug as they may relate 
to the safety and effectiveness of a drug, require prior approval of a 
supplemental application. A second category of changes may be made if 
FDA has not notified the company within 30 days after the submission of 
a supplement that prior approval is required. A third category of 
changes may be made upon submission of a supplement to the agency. The 
rule will also identify another category of changes that may be made 
without the submission of a supplement but which must be reported in an 
annual report.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/28/99                    64 FR 34608
Final Action                    04/00/02

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Howard P. Muller, Office of Regulatory Policy, 
Department of Health and Human Services, Food and Drug Administration, 
Suite 3037 (HFD-7), Center for Drug Evaluation and Research, 1451 
Rockville Pike, Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562

RIN: 0910-AB61
_______________________________________________________________________




1061. FOOD LABELING: TRANS FATTY ACIDS IN NUTRITION LABELING, NUTRIENT 
CONTENT CLAIMS, AND HEALTH CLAIMS

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

RIN: 0910-AB66
_______________________________________________________________________




1062. PRESUBMISSION CONFERENCES

Priority: Substantive, Nonsignificant

Legal Authority: 21 USC 360b

CFR Citation: 21 CFR 514

Legal Deadline: None

Abstract: This rule will implement section 512(b)(3) of the Federal 
Food, Drug, and Cosmetic Act (the Act). This section of the Act states 
that any person intending to file a new animal drug application or 
supplemental new animal drug application, or to investigate a new 
animal drug is entitled to one or more conferences with the agency 
prior to submission to reach an agreement establishing a submission or 
investigational requirement. This rule would describe how to request a 
presubmission conference and describe the procedures for the conduct of 
presubmission conferences.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            08/25/00                    65 FR 51782
Final Rule                      06/00/02

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Federalism:  Undetermined

Agency Contact: Gail Schmerfeld, Special Assistant, Department of 
Health and Human Services, Food and Drug Administration, HFV-100, 
Center for Veterinary Medicine, 7500 Standish Place, Rockville, MD 
20855
Phone: 301 827-1796

RIN: 0910-AB68
_______________________________________________________________________




1063. SURGEON'S AND PATIENT EXAMINATION GLOVES; RECLASSIFICATION

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

Unfunded Mandates: Undetermined

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

CFR Citation: 21 CFR 801.437; 21 CFR 878.4460; 21 CFR 878.4461; 21 CFR 
880.6250; 21 CFR 880.6251; 21 CFR 801.440

Legal Deadline: None

Abstract: FDA is revising its present regulations governing the 
classification of surgeon's and patient examination gloves. The present 
rule classifies surgeon's and patient examination gloves as class I 
devices. FDA is reclassifying surgeon's and patient examination gloves 
as class II devices subject to special controls. FDA is also requiring 
additional labeling concerning powder and protein levels and expiration 
dating for these devices.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            07/30/99                    64 FR 41710
Final Action                    06/00/02

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Agency Contact: Joseph M. Sheehan, Chief, Regulations Staff, Department 
of Health and Human Services, Food and Drug Administration, HFZ-215, 
Center

[[Page 61590]]

for Devices and Radiological Health, 1350 Piccard Drive, Rockville, MD 
20850
Phone: 301 827-2974

RIN: 0910-AB74
_______________________________________________________________________




1064. CGMPS FOR BLOOD AND BLOOD COMPONENTS: NOTIFICATION OF CONSIGNEES 
AND TRANSFUSION RECIPIENTS RECEIVING BLOOD AND BLOOD COMPONENTS AT 
INCREASED RISK OF TRANSMITTING HCV (LOOKBACK)

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

RIN: 0910-AB76
_______________________________________________________________________




1065. ANTIBIOTIC RESISTANCE LABELING

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

Unfunded Mandates: Undetermined

Legal Authority: 21 USC 321; 21 USC 371; 21 USC 374; 21 USC 379e; 42 
USC 216; 42 USC 241; 42 USC 262; 21 USC 331; 21 USC 351 to 353; 21 USC 
355; 21 USC 358; 21 USC 360; 21 USC 360b; ...

CFR Citation: 21 CFR 201.24

Legal Deadline: None

Abstract: The final rule would require the inclusion of statements on 
antibiotic prescription drug labeling concerning inappropriate 
antibiotic use and the prevalence of drug resistant microorganisms.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/19/00                    65 FR 56511
Final Rule                      04/00/02

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Federalism:  Undetermined

Agency Contact: Christine Rogers, Regulatory Counsel, Department of 
Health and Human Services, Food and Drug Administration, Suite 3059 
(HFD-7), Center for Drug Evaluation and Research, 1451 Rockville Pike, 
Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562

RIN: 0910-AB78
_______________________________________________________________________




1066. 180-DAY GENERIC DRUG EXCLUSIVITY FOR ABBREVIATED NEW DRUG 
APPLICATIONS

Priority: Substantive, Nonsignificant

Unfunded Mandates: Undetermined

Legal Authority: 21 USC 321; 21 USC 331; 21 USC 351; 21 USC 352; 21 USC 
353; 21 USC 355; 21 USC 371; 21 USC 374; 21 USC 379e

CFR Citation: 21 CFR 314.107

Legal Deadline: None

Abstract: The final rule will amend regulations governing 180-day 
generic drug exclusivity to clarify existing eligibility requirements 
and conditions for abbreviated new drug application sponsors, to modify 
current eligibility requirements, and to impose new eligibility 
conditions. These revisions are the result of recent court decisions, 
including Mova Pharmaceutical v. Shalala, 140 F. 3d 1060 (D.C. Cir. 
1998), invalidating an eligibility requirement for exclusivity.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            08/06/99                    64 FR 42873
NPRM Comment Period End         10/04/99
Final Action                    06/00/02

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: Undetermined

Agency Contact: Virginia G. Beakes, 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, 1451 Rockville Pike, Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562
Email: [email protected]

RIN: 0910-AB80
_______________________________________________________________________




1067. FOOD ADDITIVES: FOOD CONTACT SUBSTANCES NOTIFICATION SYSTEM

Priority: Substantive, Nonsignificant

Legal Authority: 21 USC 321 et seq

CFR Citation: 21 CFR 20.100; 21 CFR 58.3; 21 CFR 170.3; 21 CFR 170.100; 
21 CFR 170.101; 21 CFR 170.102; 21 CFR 170.103; 21 CFR 170.104; 21 CFR 
170.105; 21 CFR 171.1; 21 CFR 171.4; 21 CFR 174.5; 21 CFR 179.25; 21 
CFR 170.106; ...

Legal Deadline: None

Abstract: In November 1997, Congress amended the Federal Food, Drug, 
and Cosmetic Act (FFD&C) to establish a notification process whereby 
manufacturers and suppliers of components of food contact materials may 
notify FDA 120 days prior to marketing a new food contact substance. If 
FDA does not object to the notification within 120 days, the substance 
may be marketed with the same status as a regulated food additive. FDA 
is authorized to publish regulations outlining the information required 
to be submitted in premarket notifications for food-contact substances 
submitted to the agency. FDA is also authorized to publish regulations 
that identify when a food additive petition is required in lieu of a 
premarket notification. FDA is not required to accept a premarket 
notification in any fiscal year for which an appropriation is not 
specifically made for this program. FDA expects that the majority of 
food-contact substances that are currently the subject of food additive 
petitions will be the subject of premarket notifications. FDA also 
expects that substances currently reviewed under the agency's threshold 
of regulation process will be reviewed as premarket notifications under 
the new process. Unlike food additive regulations, premarket 
notifications will be specific to the notifier. The proposed use of a 
similar or identical substance produced by another manufacturer will 
require a separate premarket notification submission. Also unlike food 
additive petitions, the existence of the notification and any otherwise 
releasable data within the notification is not publicly available until 
the 120-day period has expired. FDA expects to keep a publicly 
available list of effective premarket notifications to assist 
manufacturers, distributors, and users of food packaging and other 
food-contact materials. FDA published a proposed rule on the 
notification process for food contact substances on July 13, 2000. The 
comment period on the proposed rule ended on September 26, 2000. Three 
comments were received on the proposed rule.

[[Page 61591]]

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            07/13/00                    65 FR 43269
Final Rule                      12/00/01

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Mitchell Alan Cheeseman, Team Leader, Department of 
Health and Human Services, Food and Drug Administration, HFS-215, 
Center for Food Safety and Applied Nutrition, 200 C Street SW, 
Washington, DC 20204
Phone: 202 418-3083
Fax: 202 418-3131
Email: [email protected]

RIN: 0910-AB94
_______________________________________________________________________




1068. MARKING REQUIREMENTS FOR AND PROHIBITIONS ON THE REIMPORTATION OF 
IMPORTED FOOD PRODUCTS THAT HAVE BEEN REFUSED ADMISSION INTO THE UNITED 
STATES

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

RIN: 0910-AB95
_______________________________________________________________________




1069. STATE CERTIFICATION OF MAMMOGRAPHY FACILITIES

Priority: Other Significant

Legal Authority: 42 USC 263b

CFR Citation: 21 CFR 900.2; 21 CFR 900.20; 21 CFR 900.21; 21 CFR 
900.22; 21 CFR 900.23; 21 CFR 900.24; 21 CFR 900.25

Legal Deadline: None

Abstract: FDA is considering regulations to implement section (q) of 
the Mammography Quality Standards Act of 1992 (the MQSA). This section 
permits FDA to authorize individual States to certify mammography 
facilities, to conduct the inspection of the facilities, to implement 
the MQSA quality standards, and to administer other related functions. 
FDA retains oversight responsibility for the activities of the States 
authorized to carry out certification requirements and mammography 
facilities certified by those States must continue to meet the quality 
standards established by FDA for mammography facilities nationwide. The 
rule would include procedures for application, approval, evaluation, 
and withdrawal of approval of States as Certification Agencies. It also 
would include standards to be met by States receiving this authority.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            03/30/00                    65 FR 16847
NPRM Comment Period End         06/28/00
Final Rule                      02/00/02

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: Ruth Fischer, Office of Health and Industry Programs, 
Department of Health and Human Services, Food and Drug Administration, 
HFZ-215, Center for Devices and Radiological Health, 1350 Piccard 
Drive, Rockville, MD 20850
Phone: 301 827-2960

RIN: 0910-AB98
_______________________________________________________________________




1070. AVAILABILITY FOR PUBLIC DISCLOSURE AND SUBMISSION TO FDA FOR 
PUBLIC DISCLOSURE OF CERTAIN DATA AND INFORMATION RELATED TO GENE 
THERAPY OR XENOTRANSPLANTATION

Priority: Other Significant

Legal Authority: 5 USC 552; 21 USC 331(j); 18 USC 1905; 21 USC 355(i); 
21 USC 371(a); 42 USC 264

CFR Citation: 21 CFR 20.100; 21 CFR 312.42; 21 CFR 312.130; 21 CFR 
601.50; 21 CFR 601.51; 21 CFR 601.52; 21 CFR 601.53

Legal Deadline: None

Abstract: The regulation would require sponsors of human trials 
involving human gene therapy or xenotransplantation to submit a 
redacted version for public disclosure of an investigational new drug 
application (IND), an amendment to an IND, or other related documents. 
The submission would be redacted to exclude trade secret information 
and personal information, the disclosure of which would constitute a 
clearly unwarranted invasion of personal privacy. FDA would then make 
the redacted documents available to the general public and the 
information would be available for discussion in open session at 
scientific advisory committee meetings and at other suitable fora.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            01/18/01                     66 FR 4688
NPRM Comment Period End         04/18/01
Final Action                    05/00/02

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Steven F. Falter, Director, Regulations and Policy 
Staff, 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: 301 594-1944
Email: [email protected]

RIN: 0910-AC00
_______________________________________________________________________




1071. EXAMINATION OF ADMINISTRATIVE RECORD AND OTHER ADVISORY COMMITTEE 
RECORDS

Priority: Substantive, Nonsignificant

Legal Authority: 21 USC 321

CFR Citation: 21 CFR 14.75

Legal Deadline: None

Abstract: FDA is amending its administrative regulations in 21 CFR 
14.75(a) to state that written information for consideration by an 
advisory committee at an advisory committee meeting is available for 
public disclosure, whenever practicable, before or at the time of the 
meeting.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            01/08/01                     66 FR 1275
Direct Final Rule               01/08/01                     66 FR 1257
Direct Final Rule Withdrawn     04/23/01                    66 FR 20401
Final Rule                      08/00/02

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Andrea C. Masciale, Regulatory Counsel, Office of

[[Page 61592]]

Regulatory Policy, Department of Health and Human Services, Food and 
Drug Administration, Suite 3037 (HFD-7), Center for Drug Evaluation and 
Research, 1451 Rockville Pike, Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562

RIN: 0910-AC03
_______________________________________________________________________




1072. EFFICACY EVIDENCE NEEDED FOR PRODUCTS TO BE USED AGAINST TOXIC 
SUBSTANCES WHEN HUMAN STUDIES ARE UNETHICAL

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

RIN: 0910-AC05
_______________________________________________________________________




1073. 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: Other, Statutory, April 17, 2001, The Children's Health 
Act of 2000 requires FDA to adopt existing HHS regulations within six 
months of the date of its enactment on 10/17/2000. Thus FDA is required 
to adopt HHS Subpart D by 4/17/2001.

Abstract: The final rule will finalize the interim rule that published 
in April 2001 and provide 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 Rule                      03/00/02

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Carol Drew, 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, 1451 Rockville Pike, Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562

RIN: 0910-AC07
_______________________________________________________________________




1074. IMPLEMENTING COURT DECISIONS, ANDA APPROVALS, AND 180-DAY 
EXCLUSIVITY

Priority: Substantive, Nonsignificant

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 314.107(e)

Legal Deadline: None

Abstract: The interim rule will amend regulations governing 180-day 
generic drug exclusivity to redefine the term court decision. The 
definition of court decision will be changed to the decision of a 
District Court deciding the relevant patent litigation case. The 
regulations will then correctly define court decision in accordance 
with recent court holdings addressing the definition.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              07/13/00                    65 FR 43233
Final Rule                      06/00/02

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Virginia G. Beakes, 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, 1451 Rockville Pike, Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562
Email: [email protected]

RIN: 0910-AC11
_______________________________________________________________________




1075. REVOCATION OF CONDITIONS FOR MARKETING DIGOXIN PRODUCTS FOR ORAL 
USE

Priority: Substantive, Nonsignificant

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

CFR Citation: 21 CFR 310.500

Legal Deadline: None

Abstract: The final rule will revoke the regulation (21 CFR 310.500) 
that established conditions for marketing digoxin products for oral 
use.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            11/24/00                    65 FR 70538
Final Rule                      06/00/02

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Mary E. Catchings, Regulatory Counsel, Office of 
Regulatory Policy, Department of Health and Human Services, Food and 
Drug Administration, HFD-7, Center for Drug Evaluation and Research, 
1451 Rockville Pike, Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-0951

RIN: 0910-AC12
_______________________________________________________________________




1076.  ADDITIONAL CRITERIA AND PROCEDURES FOR CLASSIFYING OVER-
THE-COUNTER DRUGS AS GENERALLY RECOGNIZED AS SAFE AND EFFECTIVE AND NOT 
MISBRANDED

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

RIN: 0910-AC22

[[Page 61593]]

_______________________________________________________________________


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


Food and Drug Administration (FDA)



_______________________________________________________________________




1077. INFANT FORMULA: REQUIREMENTS PERTAINING TO GOOD MANUFACTURING 
PRACTICE, QUALITY CONTROL PROCEDURES, QUALITY FACTORS, NOTIFICATION 
REQUIREMENTS, AND 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.

Timetable:
________________________________________________________________________

Current Good Mfg. Practices; Qual. Control Proc.  NPRM 07/09/96 (61 FR 
36154)  NPRM Comment Period End 12/06/96  Final Action To Be Determined

Infant Form Cons Comp, Micro Test & Recd Retention Req  NPRM 01/26/89 
(54 FR 3783)  NPRM Comment Period End 03/27/89  Final Rule 12/24/91 (56 
FR 66566)

Infant Formula Quality Factors  NPRM 07/09/96 (61 FR 36154)  NPRM 
Comment Period End 12/06/96  Final Action To Be Determined

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Darla Danford, Supervisory Nutritionist, Department of 
Health and Human Services, Food and Drug Administration, (HFS-800), 
Center for Food Safety and Applied Nutrition, 200 C Street SW, 
Washington, DC 20204
Phone: 202 205-5365

RIN: 0910-AA04
_______________________________________________________________________




1078. FOOD LABELING REVIEW

Priority: Routine and Frequent

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

CFR Citation: 21 CFR 100; 21 CFR 101; 21 CFR 102; 21 CFR 161

Legal Deadline: None

Abstract: The Nutrition Labeling and Education Act of 1990 (NLEA) 
requires that most foods bear nutrition labeling. The agency issued 
final rules implementing most of the provisions contained in the NLEA 
on January 6, 1993. Subsequently, however, the agency has identified 
additional areas that should be the subject of rulemaking. FDA issued a 
proposal on January 6, 1993, to establish requirements for the 
identification of certain ingredients on food labels. FDA proposed on 
June 15, 1993, to amend its January 6, 1993, final rules on nutrient 
content and health claims to remove the provisions that exempted 
restaurant menus from the requirements for how nutrient content claims 
and health claims are to be made. The agency proposed on January 4, 
1994, to establish reference daily intakes based on the 9th and 10th 
editions of the National Research Council's Recommended Dietary 
Allowances. On March 14, 1994, FDA published a proposal implementing 
the provisions for exemptions from nutrition labeling for low-volume 
food products of small businesses that were established by the 
Nutrition Labeling and Education Act Amendments of 1993. On August 18, 
1993, FDA published a proposal concerning the placement of the 
nutrition facts panel on food labels. Finally, on July 18, 1994, FDA 
published proposed revised guidelines for the voluntary declaration of 
nutrition labeling for raw produce and fish. A final rule concerning 
the placement of the nutrition facts panel was published on April 5, 
1995. A final rule establishing reference daily intakes based on the 
9th and 10th editions of Recommended Dietary Allowances was published 
on December 28, 1995.
FDA published a final rule on August 2, 1996, on nutrient content 
claims and health claims to remove the provisions that exempted 
restaurant menus from the requirements for how nutrient content claims 
and health claims are to be made. FDA published a final rule on August 
7, 1996, implementing the exemption for small businesses from the 
requirements for nutrition labeling and providing instructions on how 
to file a notice claiming the exemption. FDA published on August 16, 
1996, final guidelines on the voluntary declaration of nutrition 
labeling for raw produce and fish.

Timetable:
________________________________________________________________________

Amend Standard of Identity for Grain Products (Folic Acid)  NPRM 10/14/
93 (58 FR 53305)  Final Action 03/05/96 (61 FR 8781)

Health Claims and Label Statements  NPRM Folic Acid and Neural Tube Def 
10/14/93 (58 FR 53254)  Final Action 03/05/96 (61 FR 8752)

Misleading Containers; Nonfunctional Slack Fill  NPRM 01/06/93 (58 FR 
2957)  Final Action 12/06/93 (58 FR 64123)

Nutrient Content Claims and Health Claims; Restaurant Foods  NPRM 06/
15/93 (58 FR 33055)  Final Action 08/02/96 (61 FR 40320)

Nutrient Content, Definition of the Term, Healthy  NPRM 01/06/93 (58 FR 
2944)  Final Action 05/10/94 (59 FR 24232)

Placement of Nutrition Facts Panel  NPRM 08/18/93 (58 FR 44091)  Final 
Action 04/05/95 (60 FR 17202)  Final Action Effective 05/05/95  Final 
Action Correction 06/12/95 (60 FR 30788)

Protein Hydrolysates; Broth in Tuna; and/or Labeling  NPRM (Declaration 
of Ingredients) 01/06/93 (58 FR 2950)  Final Action (Dec. of 
Ingredients) To Be Determined

Reference Daily Intakes  NPRM 01/04/94 (59 FR 427)  Final Action 12/28/
95 (60 FR 67164)

Small Business Exemption, Nutrition Labeling  NPRM 03/14/94 (59 FR 
11872)  Final Action 08/07/96 (61 FR 40963)

Voluntary Guidelines for Nutrition Labeling Produce  NPRM 07/18/94 (59 
FR 36379)  Final Action 08/16/96 (61 FR 42742)

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: State, Federal

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

Additional Information: Federalism: Yes for Protein Hydrolysates; Broth 
in Tuna; and/or Labeling

Agency Contact: Christine L. Lewis, Director, Office of Nutritional 
Products, Labeling and Dietary Supplements, Department of Health and 
Human Services, Food and Drug Administration, (HFS-800), Center for 
Food Safety and Applied Nutrition, 200 C Street SW, Washington, DC 
20204
Phone: 202 205-4561

RIN: 0910-AA19

[[Page 61594]]

_______________________________________________________________________




1079. MEDICAL FOODS

Priority: Other Significant

Legal Authority: 21 USC 321; 21 USC 360ee; 21 USC 371; 21 USC 342; 21 
USC 343; 21 USC 348; 21 USC 350; 21 USC 350a; 21 USC 351; 21 USC 352; 
21 USC 355

CFR Citation: Not Yet Determined

Legal Deadline: None

Abstract: The Food and Drug Administration is considering development 
of regulations for medical foods, as defined by the Orphan Drug Act 
Amendments of 1988 (21 U.S.C. 360ee(b)(3)) to assure, among other 
things, the safety and effectiveness of these products, proper labeling 
of the nutrient content and purported uses, including adequate and 
appropriate directions for use, and quality control and good 
manufacturing practices.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

ANPRM                           11/29/96                    61 FR 60661
ANPRM Comment Period End        04/28/97
NPRM                             To Be                       Determined

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: State, Federal

Federalism:  Undetermined

Agency Contact: Sue A. Anderson, Department of Health and Human 
Services, Food and Drug Administration, (HFS-831), Center for Food 
Safety and Applied, Nutrition, 200 C Street SW, Washington, DC 20204
Phone: 202 205-4240

RIN: 0910-AA20
_______________________________________________________________________




1080. DIRECT-TO-CONSUMER PROMOTION REGULATIONS

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

Unfunded Mandates: Undetermined

Legal Authority: 21 USC 321; 21 USC 360k; 21 USC 361; 21 USC 362; 21 
USC 371; 21 USC 331; 21 USC 334; 21 USC 351; 21 USC 352; 21 USC 353; 21 
USC 355; 21 USC 358; 21 USC 360e to 360i

CFR Citation: 21 CFR 200; 21 CFR 800

Legal Deadline: None

Abstract: The Food and Drug Administration will issue proposed 
regulations for direct-to-consumer promotion of human and animal 
prescription drugs, biologics, and restricted devices. The regulations 
will set forth the requirements for what type of information shall be 
contained in the consumer directed advertisements for these products 
and how the information shall be presented.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/00/02

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Federalism:  Undetermined

Agency Contact: Nancy M. Ostrove, Division of Drug Marketing, 
Advertising, and Communications, Department of Health and Human 
Services, Food and Drug Administration, (HFD-42), Center for Drug 
Evaluation and Research, 5600 Fishers Lane, Rockville, MD 20857
Phone: 301 827-2828

RIN: 0910-AA90
_______________________________________________________________________




1081. INVESTIGATIONAL USE NEW ANIMAL DRUG REGULATIONS (SECTION 610 
REVIEW)

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

Unfunded Mandates: Undetermined

Legal Authority: 5 USC 610; 21 USC 351; 21 USC 353; 21 USC 360b; 21 USC 
371; 21 USC 321; 21 USC 352

CFR Citation: 21 CFR 511; 21 CFR 512

Legal Deadline: None

Abstract: FDA is proposing to revise its regulations governing 
investigational use of new animal drugs by proposing to delete 21 CFR 
511 and establish in 21 CFR part 512 revised investigational use of new 
animal drug regulations. The investigational use new animal drug 
regulations are expected to include regulations to implement provisions 
of the Animal Drug Availability Act of 1996, specifically presubmission 
conferences, and implement parts of the President's National 
Performance Report, ``Reinventing the Regulation of Animal Drugs,'' May 
1996. In the reinventing regulations report, FDA proposed to revise its 
regulations to reflect numerous new process changes and programs that 
will enable a more streamlined animal drug application review and 
approval process, and that would result in less regulatory burden upon 
industry and FDA while maintaining the safety and effectiveness of new 
animal drugs. In addition, FDA is initiating a review of this rule 
under section 610 of the Regulatory Flexibility Act. The purpose of the 
section 610 review is to determine if the rule should be amended to 
minimize adverse economic impacts on small entities. FDA will consider 
and solicit comments on the following: 1) the continued need for the 
rule; 2) the nature of complaints or comments received concerning the 
rule; 3) the complexity of the rule; 4) the extent to which the rule 
overlaps, duplicates, or conflicts with other Federal, State or local 
government rules; and 5) the degree to which technology, economic 
conditions or other factors have changed in the area affected by the 
rule.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

ANPRM                           11/21/96                    61 FR 59209
ANPRM Comment Period End        01/21/97
Begin Review                    04/03/00
Proposed Rule                   02/00/03

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected: Businesses

Government Levels Affected: Undetermined

Federalism:  Undetermined

Agency Contact: Marty Schoenemann, Department of Health and Human 
Services, Food and Drug Administration, HFV-126, Center for Veterinary 
Medicine, 7500 Standish Place, Rockville, MD 20855
Phone: 301 827-0220

RIN: 0910-AB02
_______________________________________________________________________




1082. SUITABILITY DETERMINATION FOR DONORS OF HUMAN CELLULAR AND TISSUE-
BASED PRODUCTS

Priority: Other Significant

Legal Authority: 42 USC 216; 42 USC 243; 42 USC 262; 42 USC 263a; 42 
USC 264; 42 USC 271

CFR Citation: 21 CFR 210.1(c); 21 CFR 210.2(a); 21 CFR 210.2(b); 21 CFR

[[Page 61595]]

211.1(b); 21 CFR 820.1(a)(1); 21 CFR 820.1(c); 21 CFR 1271

Legal Deadline: None

Abstract: As part of implementing the proposed regulatory approach to 
human cells, tissues, and cellular and tissue-based products, the Food 
and Drug Administration is requiring manufacturers of human cells, 
tissues, and cellular and tissue-based products to screen and test the 
donors of cells and tissues used in those products for evidence of or 
risk factors for relevant communicable disease. As part of this action, 
the agency is amending the current good manufacturing practice 
regulations that apply to human cells, tissues, and cellular and 
tissue-based products regulated as drugs, medical devices, and/or 
biological products in order to incorporate the new donor suitability 
requirements into existing good manufacturing practice regulations for 
those products.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/30/99                    64 FR 52696
NPRM Comment Period Reopened    04/18/00                    65 FR 20774
NPRM Comment Period End         07/17/00
Final Action                    01/00/03

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: State

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

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

RIN: 0910-AB27
_______________________________________________________________________




1083. CURRENT GOOD TISSUE PRACTICE FOR MANUFACTURERS OF HUMAN CELLULAR 
AND TISSUE-BASED PRODUCTS

Priority: Other Significant

Legal Authority: 42 USC 216; 42 USC 243; 42 USC 263a; 42 USC 264; 42 
USC 271

CFR Citation: 21 CFR 1271

Legal Deadline: None

Abstract: As part of implementing the proposed regulatory approach to 
human cells, tissues, and cellular and tissue-based products, the Food 
and Drug Administration (FDA) is proposing to require manufacturers of 
human cells and tissue to follow current good tissue practice (GTP), 
which includes proper handling, processing, and storage of human cells 
and tissue, recordkeeping, and the maintenance of a quality program. 
FDA is also proposing to amend the current good manufacturing practice 
regulations that apply to medical device products and human drug 
products in order to incorporate the new GTP requirements into existing 
good manufacturing practice regulations.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            01/08/01                     66 FR 1508
NPRM Comment Period End         05/08/01
Final Action                    01/00/03

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: 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

RIN: 0910-AB28
_______________________________________________________________________




1084. REQUIREMENTS FOR LIQUID MEDICATED FEED AND FREE-CHOICE MEDICATED 
FEED

Priority: Substantive, Nonsignificant

Legal Authority: PL 104-250; 21 USC 360b

CFR Citation: 21 CFR 558.5; 21 CFR 510.455

Legal Deadline: None

Abstract: In response to a citizen petition filed by the American Feed 
Industry Association, the Food and Drug Administration (FDA) is 
proposing to amend the requirements for liquid medicated animal feed to 
clarify what information and data are required to demonstrate chemical 
and positional stability. The amended regulations would also clarify 
the provisions for the submission of such data through a master file 
and the reference to master files by subsequent applicants. 
Additionally, FDA is proposing to amend the regulations for free-choice 
medicated feed in order to ensure consistency with the requirements for 
liquid medicated feed. Finally, FDA is proposing to amend the 
regulations for free-choice medicated feed and liquid medicated feed so 
that these provisions comply with the terms of the Animal Drug 
Availability Act of 1996.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                             To Be                       Determined

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Federalism:  Undetermined

Agency Contact: William D. Price, Special Assistant, Department of 
Health and Human Services, Food and Drug Administration, HFV-200, 
Center for Veterinary Medicine, 7500 Standish Place, Rockville, MD 
20855
Phone: 301 827-6652
Fax: 301 594-4512

RIN: 0910-AB50
_______________________________________________________________________




1085. BULK DRUG SUBSTANCES FOR USE IN PHARMACY COMPOUNDING

Priority: Other Significant

Legal Authority: PL 105-115, sec 127; 21 USC 351; 21 USC 352; 21 USC 
353a; 21 USC 355; 21 USC 371

CFR Citation: 21 CFR 216

Legal Deadline: None

Abstract: Section 127 of the Food and Drug Administration Modernization 
Act of 1997 (Pub. L. 105-115) added section 503A to the Food, Drug, and 
Cosmetic Act (21 U.S.C. 353a). Section 503A governs the application of 
Federal law to the practice of pharmacy compounding. Under section 
503A(b)(1)(A), FDA may issue by regulation a list of bulk drug 
substances that may be used in compounding that are not covered by a 
United States Pharmacopeia (USP) or National Formulary (NF) monograph 
and are not

[[Page 61596]]

components of FDA-approved drugs. Bulk drug substances that do not 
appear on the list may not be used in compunding under section 127 
unless such substances are covered by USP or NF monograph or are 
components of approved drugs.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            01/07/99                      64 FR 996
NPRM Comment Period End         03/23/99
Final Action                     To Be                       Determined

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: None

Agency Contact: Wayne H. Mitchell, Regulatory Counsel, Office of 
Regulatory Policy, Department of Health and Human Services, Food and 
Drug Administration, Suite 3037 (HFD-7), Center for Drug Evaluation and 
Research, 1451 Rockville Pike, Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562
Email: [email protected]

RIN: 0910-AB57
_______________________________________________________________________




1086. PHARMACY AND PHYSICIAN COMPOUNDING OF DRUG PRODUCTS

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

Unfunded Mandates: Undetermined

Legal Authority: 21 USC 331; 21 USC 351; 21 USC 352; 21 USC 353a; 21 
USC 355; 21 USC 360; 21 USC 371

CFR Citation: 21 CFR 216

Legal Deadline: None

Abstract: Section 503A of the Federal Food, Drug, and Cosmetic Act (the 
Act) (21 U.S.C. 353a) describes the circumstances under which 
compounded drugs may qualify for exemption from three requirements of 
the Act: (1) that a drug be manufactured according to current good 
manufacturing practice; (2) that a drug have adequate directions for 
use; and (3) that a marketing application be approved by FDA before a 
new drug product is introduced for sale (i.e., sections 501(a)(2)(B), 
502(f)(1), and 505 of the Act (21 U.S.C. 351(a)(2)(B), 352(f)(1), and 
355)). To qualify for the exemption, a pharmacist or physician must 
meet statutory conditions for compounding, including the following: (1) 
there generally must be a prescription for an identified individual 
patient before compounding; (2) compounding before receiving a 
prescription is allowed only under limited circumstances; (3) the 
quantity of drugs that may be shipped out of State is limited and may 
vary depending on whether the compounder is located in a State that has 
entered into a memorandum of understanding (MOU) with FDA; (4) drug 
products may only be compounded using a bulk drug substance (which is 
essentially the active ingredient) that is listed in the United States 
Pharmacopoeia (USP) or National Formulary (NF), or a bulk drug 
substance that is a component of an FDA-approved drug product, or a 
bulk drug substance that is listed in the regulation as one that FDA 
has found to be suitable for compounding; (5) the bulk drug substance 
must be made in a facility registered with FDA and the bulk drug 
substance must be accompanied by a certificate of analysis; (6) they 
cannot compound regularly or in inordinate amounts any drug products 
that are essentially copies of commercially available products; (7) 
drug products may not be compounded if they are listed in a regulation 
as having been removed from the market or had their FDA-approval 
withdrawn because they were found to be not safe or not effective; (8) 
drug products that are listed in the regulations as ``demonstrably 
difficult to compound'' may not be compounded. The regulations will 
amplify and explain the statutory requirements as well as execute tasks 
Congress assigned FDA in section 503A. This proposed rule will be one 
of several rulemakings implementing section 503A. Related regulatory 
initiatives are described below: (1) FDA has issued a final rule 
listing drug products that may not be compounded because they were 
found to be not safe or not effective and were removed from the market 
or had their FDA approval withdrawn; (2) FDA has also issued a proposed 
rule and is preparing a final rule listing drugs that are not the 
subject of a USP or NF monograph, and are not components of an FDA-
approved drug product but are suitable for compounding; (3) FDA is 
currently preparing a proposed rule listing those drugs that are 
demonstrably difficult to compound and are not allowed to be 
compounded; and (4) FDA has published a Federal Register notice 
announcing the availability of a draft MOU between FDA and State boards 
of pharmacy.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                             To Be                       Determined

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: State, Federal

Federalism:  Undetermined

Additional Information: See RINs 0910-AB57, 0910-AB59

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, 1451 Rockville Pike, Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562
Email: [email protected]

RIN: 0910-AB58
_______________________________________________________________________




1087. DRUG PRODUCTS THAT PRESENT DEMONSTRABLE DIFFICULTIES FOR 
COMPOUNDING BECAUSE OF REASONS OF SAFETY OR EFFECTIVENESS

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

Unfunded Mandates: Undetermined

Legal Authority: PL 105-115, sec 127

CFR Citation: 21 CFR 216

Legal Deadline: None

Abstract: Section 127 of the Food and Drug Administration Modernization 
Act of 1997 (Pub. L. 105-115) added section 503A to the Food, Drug, and 
Cosmetic Act (21 U.S.C. 353a). Section 503A exempts compounded drug 
products, under certain circumstances, from several key provisions of 
the Food, Drug, and Cosmetic Act. Section 503A(b)(3)(A) directs FDA to 
issue by regulation a list of drug products that, if compounded, will 
not qualify for these exemptions because their compounding would be 
demonstrably difficult in terms of assuring the safety or effectiveness 
of the compounded product.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                             To Be                       Determined

[[Page 61597]]

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Federalism:  Undetermined

Agency Contact: Andrea C. Masciale, 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, 1451 Rockville Pike, Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562

RIN: 0910-AB59
_______________________________________________________________________




1088. IMPLEMENTATION OF THE IMPORT TOLERANCE PROVISIONS OF THE ANIMAL 
DRUG AVAILABILITY ACT OF 1996

Priority: Substantive, Nonsignificant

Unfunded Mandates: Undetermined

Legal Authority: 21 USC 360b

CFR Citation: 21 CFR 556

Legal Deadline: None

Abstract: Section 4 of the Animal Drug Availability Act of 1996 (ADAA) 
(Pub. L. 104-250) permits the Secretary of HHS to establish tolerances 
for animal drugs used or intended for use in animals grown in an 
exporting nation from which an edible portion is imported into the 
United States. The standards used to establish tolerances are to be 
similar to the food safety criteria used by the Secretary to establish 
tolerances for drugs administered to animals grown in the United 
States. The data used for establishing the tolerances may be from the 
manufacturer and include data upon which a foreign approval is based or 
data available to an international organization such as the Codex 
Alimentarius Commission. This rule would implement the provisions in 
ADAA.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

ANPRM                           08/10/01                    66 FR 42167
NPRM                            12/00/02

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Federalism:  Undetermined

Agency Contact: Frances Pell, Consumer Safety Officer, Department of 
Health and Human Services, Food and Drug Administration, HFV-1, Center 
for Veterinary Medicine, 7500 Standish Place, Rockville, MD 20855
Phone: 301 827-0188
Email: [email protected]

RIN: 0910-AB71
_______________________________________________________________________




1089. MANDATORY HACCP REGULATIONS FOR MANUFACTURERS OF RENDERED PRODUCTS

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

Unfunded Mandates: Undetermined

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

CFR Citation: 21 CFR 589

Legal Deadline: None

Abstract: During the notice and comment rulemaking for 21 CFR part 589, 
``Listing of Specific Substances Prohibited from Use in Animal Food or 
Feed; Animal Proteins Prohibited in Ruminant Feed,'' FDA received 
several comments supporting the application of mandatory Hazard 
Analysis Critical Control Point (HACCP) regulations for renderers. Some 
of these comments were from renderers. Because of the need to expedite 
the rulemaking for 21 CFR part 589, FDA stated that it would take up 
the HACCP regulations for renderers as a separate initiative. This 
rulemaking is to address the need expressed in the comments to 21 CFR 
part 589 by promulgating mandatory HACCP regulations for renderers.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                             To Be                       Determined

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Federalism:  Undetermined

Agency Contact: Daniel G. McChesney, Deputy Director, Office of 
Surveillance and Compliance, Department of Health and Human Services, 
Food and Drug Administration, HFV-200, Center for Veterinary Medicine, 
7500 Standish Place, Rockville, MD 20855
Phone: 301 827-6648

RIN: 0910-AB72
_______________________________________________________________________




1090. CITIZEN PETITIONS; ACTIONS THAT CAN BE REQUESTED BY PETITION; 
DENIALS, WITHDRAWALS, AND REFERRALS FOR OTHER ADMINISTRATIVE ACTION

Priority: Info./Admin./Other

Legal Authority: 5 USC 551 to 558; 21 USC 1034; 28 USC 2112; 42 USC 
201; 42 USC 262; 42 USC 263b to 263n; 42 USC 264; 5 USC 701 to 706; 15 
USC 1451 to 1461; 21 USC 41 to 50; 21 USC 141 to 149; 21 USC 321 to 
393; 21 USC 467f; 21 USC 679; 21 USC 821

CFR Citation: 21 CFR 10

Legal Deadline: None

Abstract: The final rule would amend the agency's regulations 
pertaining to citizen petitions by specifying the types of actions that 
could be requested through a petition. The final rule would also revise 
the content requirements for citizen petitions and would allow the 
agency to take various administrative actions in response to citizen 
petitions. These changes are intended to improve the citizen petition 
mechanism by focusing FDA's resources on important public health 
issues.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            11/30/99                    64 FR 66822
NPRM Comment Period End         02/28/00
Final Action                     To Be                       Determined

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, Planning and Legislation, 5600 Fishers Lane, 
Rockville, MD 20857
Phone: 301 827-0587
Fax: 301 827-4774
Email: [email protected]

RIN: 0910-AB73
_______________________________________________________________________




1091. STABILITY TESTING OF DRUGS

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

Unfunded Mandates: Undetermined

Legal Authority: 21 USC 321; 21 USC 331; 21 USC 351; 21 USC 352; 21 USC 
353; 21 USC 355; 21 USC 371; 21 USC 374; 21 USC 379e

CFR Citation: 21 CFR 314

[[Page 61598]]

Legal Deadline: None

Abstract: The proposed rule would specify required stability data that 
must be submitted with new drug applications.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/00/02

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Federalism:  Undetermined

Agency Contact: Christine Rogers, Regulatory Counsel, Department of 
Health and Human Services, Food and Drug Administration, Suite 3059 
(HFD-7), Center for Drug Evaluation and Research, 1451 Rockville Pike, 
Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562

RIN: 0910-AB82
_______________________________________________________________________




1092. SUBSTANCES PROHIBITED FROM USE IN ANIMAL FOOD OR FEED

Priority: Substantive, Nonsignificant

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

CFR Citation: 21 CFR 589

Legal Deadline: None

Abstract: After determining that dioxins were present in some clays 
used as anti-caking agents in animal feeds, the agency is considering 
proposing a rule that would prohibit the use of these clays unless they 
meet certain conditions under the Federal Food, Drug, and Cosmetic Act. 
At this time, it is not clear whether there are other types of mined 
clay products that contain dioxins or whether the relatively low 
concentrations found in recent samples of mined clay products would 
have a significant impact on the public health. Thus, the advance 
notice of proposed rulemaking will request further information 
regarding the presence of dioxins in mined clay products used in animal 
feeds or feed ingredients and the significance of these dioxins to the 
public health.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

ANPRM                            To Be                       Determined

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected: No

Government Levels Affected: State

Federalism:  Undetermined

Agency Contact: Randall A. Lovell, Veterinary Medical Officer, 
Department of Health and Human Services, Food and Drug Administration, 
HFV-222, Center for Veterinary Medicine, 7500 Standish Place, 
Rockville, MD 20855
Phone: 301 827-0176
Fax: 301 827-1484
Email: [email protected]

RIN: 0910-AB90
_______________________________________________________________________




1093. ADDITION TO THE LIST OF DRUG PRODUCTS THAT HAVE BEEN WITHDRAWN 
FROM THE MARKET FOR REASONS OF SAFETY OR EFFECTIVENESS

Priority: Substantive, Nonsignificant

Legal Authority: 21 USC 353a; 21 USC 351; 21 USC 352; 21 USC 355; 21 
USC 371

CFR Citation: 21 CFR 216.24

Legal Deadline: None

Abstract: The final rule will amend 21 CFR 216.24 by adding two drug 
products, aminopyrine and astemizole, to the list of drug products that 
may not be used for pharmacy compounding under the exemptions provided 
by section 503A of the Federal Food, Drug, and Cosmetic Act because 
they have had their approval withdrawn or were removed from the market 
because the drug product or its components have been found to be unsafe 
or not effective.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            01/04/00                      65 FR 256
NPRM Comment Period End         03/20/00
Final Action                     To Be                       Determined

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Wayne H. Mitchell, Regulatory Counsel, Office of 
Regulatory Policy, Department of Health and Human Services, Food and 
Drug Administration, Suite 3037 (HFD-7), Center for Drug Evaluation and 
Research, 1451 Rockville Pike, Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562
Email: [email protected]

RIN: 0910-AC01
_______________________________________________________________________




1094. ADDITION TO THE LIST OF DRUG PRODUCTS THAT HAVE BEEN WITHDRAWN OR 
REMOVED FROM THE MARKET FOR REASONS OF SAFETY OR EFFECTIVENESS

Priority: Substantive, Nonsignificant

Legal Authority: 21 USC 353a

CFR Citation: 21 CFR 216.24

Legal Deadline: None

Abstract: The NPRM proposes to amend 21 CFR 216.24 by adding three drug 
products, grepafloxacin, troglitazone, and cisapride to the list of 
drug products that may not be used for pharmacy compounding under the 
exemptions provided by section 503A of the Federal Food, Drug, and 
Cosmetic Act because they have had their approval withdrawn or were 
removed from the market because the drug product or its components have 
been found to be unsafe or not effective.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                             To Be                       Determined

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Wayne H. Mitchell, Regulatory Counsel, Office of 
Regulatory Policy, Department of Health and Human Services, Food and 
Drug Administration, Suite 3037 (HFD-7), Center for Drug Evaluation and 
Research, 1451 Rockville Pike, Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562
Email: [email protected]

RIN: 0910-AC08
_______________________________________________________________________




1095. OVERWRAP FOR INHALATION PRODUCTS PACKAGED IN LOW DENSITY 
POLYETHYLENE (LDPE) CONTAINERS

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

Unfunded Mandates: Undetermined

[[Page 61599]]

Legal Authority: 21 USC 321; 21 USC 331; 21 USC 351 to 353; 21 USC 358; 
21 USC 360; 21 USC 371; 21 USC 374; 21 USC 375

CFR Citation: 21 CFR 200

Legal Deadline: None

Abstract: The proposed rule would require overwrap on all inhalation 
products packaged in low density polyethylene (LDPE) containers to 
prevent ingress of contaminates.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            11/00/02

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Carol Drew, 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, 1451 Rockville Pike, Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562

RIN: 0910-AC10
_______________________________________________________________________




1096. PREMARKET NOTICE CONCERNING BIOENGINEERED FOODS

Priority: Other Significant

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

CFR Citation: 21 CFR 192; 21 CFR 592

Legal Deadline: None

Abstract: The Food and Drug Administration (FDA) is requiring the 
submission to the agency of data and information regarding plant-
derived bioengineered foods that would be consumed by humans or 
animals. FDA is requiring that this submission be made at least 120 
days prior to the commercial distribution of such foods. FDA took this 
action to ensure that it has the appropriate amount of information 
about bioengineered foods to help to ensure that all market entry 
decisions by the industry are made consistently and in full compliance 
with the law. The action will permit the agency to assess on an ongoing 
basis whether plant-derived bioengineered foods comply with the 
standards of the Federal Food, Drug, and Cosmetic Act.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            01/18/01                     66 FR 4706
Final Action                     To Be                       Determined

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Linda Kahl, Consumer Safety Officer, Department of 
Health and Human Services, Food and Drug Administration, HFS-206, 
Center for Food Safety and Applied Nutrition, 200 C Street SW, 
Washington, DC 20204
Phone: 202 418-3101
Fax: 202 418-3131
Email: [email protected]

RIN: 0910-AC15
_______________________________________________________________________




1097. RESCISSION OF SUBSTANTIALLY EQUIVALENT DECISIONS AND RESCISSION 
APPEAL PROCEDURES

Priority: Substantive, Nonsignificant

Legal Authority: 21 USC 331; 21 USC 351; 21 USC 352; 21 USC 360; 21 USC 
360c; 21 USC 360e; 21 USC 360i; 21 USC 360j; 21 USC 371; 21 USC 374

CFR Citation: 21 CFR 16; 21 CFR 807

Legal Deadline: None

Abstract: FDA may rescind a decision issued under the Federal Food, 
Drug, and Cosmetic Act (the Act) that a device is substantially 
equivalent to a legally marketed device, and therefore, may be 
marketed. In addition, under this rule a premarket notification 
(commonly known as a 510(k)) holder may request administrative review 
of a proposed rescission action. This rule would standardize the 
procedures for considering rescissions.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Proposed Rule                   01/26/01                     66 FR 3526
Final Rule                       To Be                       Determined

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Joseph M. Sheehan, Chief, Regulations Staff, Department 
of Health and Human Services, Food and Drug Administration, HFZ-215, 
Center for Devices and Radiological Health, 1350 Piccard Drive, 
Rockville, MD 20850
Phone: 301 827-2974

RIN: 0910-AC16
_______________________________________________________________________




1098. 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 306c to 306f; 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; 42 USC 264

CFR Citation: 21 CFR 56.106

Legal Deadline: None

Abstract: The proposed rule would require institutional review boards 
(IRB) to register with FDA. The registration information would include 
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 proposed rule would make it easier for FDA to inspect 
IRB's and to convey information to IRB's.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                             To Be                       Determined

Regulatory Flexibility Analysis Required: Undetermined

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, Planning and Legislation, 5600 Fishers Lane, 
Rockville, MD 20857
Phone: 301 827-0587
Fax: 301 827-4774
Email: [email protected]

RIN: 0910-AC17

[[Page 61600]]

_______________________________________________________________________




1099. 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 Creutzfeldt-Jakob 
disease (CJD) in humans. CWD affects cervids in the United States and 
Canada.
CWD is endemic in cervid populations in certain areas of Colorado, 
Nebraska, and Wyoming. The disease has been identified in wild and 
farmed elk and wild deer populations. At least one published scientific 
article has reported that infectious CWD prion proteins in vitro can 
convert normal, non-infectious human prion proteins into abnormal, 
infectious forms. These data suggest that the agent of CWD could be 
transmitted to humans.
Currently, there are no validated analytical tests to identify animals 
in the pre-clinical phase of CWD, or any other TSE. CWD typically 
exhibits a long incubation period, during which time animals appear 
normal but are likely to be infectious. Therefore, FDA 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                             To Be                       Determined

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, 200 C Street SW., 
Washington, DC 20204
Phone: 202 205-4081
Fax: 202 205-4422
Email: [email protected]

RIN: 0910-AC21
_______________________________________________________________________


Department of Health and Human Services (HHS)         Completed Actions


Food and Drug Administration (FDA)



_______________________________________________________________________




1100. HEARING AIDS; PROFESSIONAL AND PATIENT LABELING; CONDITIONS FOR 
SALE

Priority: Other Significant. Major under 5 USC 801.

CFR Citation: 21 CFR 801.420; 21 CFR 801.421

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn                       10/10/01

Regulatory Flexibility Analysis Required: Yes

Government Levels Affected: State

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

Agency Contact: Joseph M. Sheehan
Phone: 301 827-2974

RIN: 0910-AA39
_______________________________________________________________________




1101. CLASSIFICATION OF COMPUTER SOFTWARE PROGRAMS THAT ARE MEDICAL 
DEVICES

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

CFR Citation: Not Yet Determined

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn                       08/31/01

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: None

Agency Contact: Charles S. Furfine
Phone: 301 443-2536

RIN: 0910-AA41
_______________________________________________________________________




1102. REINVENTING FDA FOOD REGULATIONS

Priority: Substantive, Nonsignificant

CFR Citation: 21 CFR 101; 21 CFR 145; 21 CFR 146; 21 CFR 150; 21 CFR 
152; 21 CFR 155; 21 CFR 156; 21 CFR 102; 21 CFR 103; 21 CFR 131; 21 CFR 
133; 21 CFR 135; 21 CFR 136; 21 CFR 137; 21 CFR 139; ...

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn                       08/30/01

Regulatory Flexibility Analysis Required: Yes

Government Levels Affected: State

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

Agency Contact: L. Robert Lake
Phone: 202 205-4561

RIN: 0910-AA58
_______________________________________________________________________




1103. PART 600-BIOLOGICAL PRODUCTS: GENERAL (COMPLETION OF A SECTION 610 
REVIEW)

Priority: Other Significant

Legal Authority: 21 USC 321; 21 USC 351; 21 USC 352; 21 USC 353; 21 USC 
355; 21 USC 360; 21 USC 360(i); 21 USC 371; 21 USC 374; 42 USC 216; 42 
USC 262; 42 USC 263(a); 42 USC 264; 42 USC 300aa-25

CFR Citation: None

Legal Deadline: None

Abstract: 21 CFR parts 600 through 680 describe regulations applicable 
to biological products. Part 600 describes regulations for general 
establishment standards, establishment inspections, and the reporting 
of adverse experiences applicable to manufacturers of licensed 
biological products. FDA is initiating a review under section 610 of 
the Regulatory Flexibility Act for the regulations in

[[Page 61601]]

part 600. The purpose of this review is to determine if any of the 
regulations in part 600 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 600; (2) the nature of 
complaints or comments received concerning a regulation in part 600; 
(3) the complexity of a regulation in part 600; (4) the extent to which 
a regulation in part 600 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 600.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Begin Review of Current 
Regulation                      04/03/00
End Review                      08/15/01

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Steven F. Falter, Director, Regulations and Policy 
Staff, 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: 301 594-1944
Email: [email protected]

RIN: 0910-AC06
_______________________________________________________________________


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


Health Resources and Services Administration (HRSA)



_______________________________________________________________________




1104. 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 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
NPRM Comment Period End         02/22/99
Second NPRM                     03/00/02

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: John M. Heyob, Director, Division of Practitioner Data 
Banks, Department of Health and Human Services, Public Health Service, 
Suite 300, 7519 Standish Place, Rockville, MD 20957
Phone: 301 443-2300
Fax: 301 443-6725

RIN: 0906-AA41
_______________________________________________________________________




1105. 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 (MUPs) and Primary Care 
Health Professional Shortage Areas (HPSAs). This 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
NPRM Comment Period End         01/04/99
Second NPRM                     03/00/02

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Jerilyn A. Thornburg RN., MPH., Chief, Shortage 
Designation Branch, Department of Health and Human Services, Health 
Resources and Services Administration, Room 91C4, National Center for 
Health Workforce Analysis, Bureau of Health Professions, 4350 East-West 
Highway, Bethesda, MD 20814
Phone: 301 594-0197
Email: [email protected]

RIN: 0906-AA44
_______________________________________________________________________




1106. NATIONAL VACCINE INJURY COMPENSATION PROGRAM: REVISIONS AND 
ADDITIONS TO THE VACCINE INJURY TABLE

Priority: Substantive, Nonsignificant

Legal Authority: PL 106-170; 42 USC 300aa-14

CFR Citation: 42 CFR 100

Legal Deadline: None

Abstract: This NPRM proposes several changes to the Vaccine Injury 
Table (Table) (42 CFR 100.3), which will have an effect upon petitions 
for compensation under the National Childhood Vaccine Injury

[[Page 61602]]

Compensation Program including the following: 1) amending the Table by 
adding the injury of intussusception to the Table for vaccines 
containing live, oral, rhesus-based rotavirus, a category of rotavirus 
vaccines; 2) removing residual seizure disorder and early onset Hib 
disease from the Table's Qualifications and Aids to Interpretation; 3) 
removing hemophilus influenzae type b polysaccharide vaccines from and 
adding pneumococcal conjugate vaccines to the Table; and 4) changing 
certain dates of coverage under the Table.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            11/05/01                    66 FR 55908
Final Rule                       To Be                       Determined

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Geoffrey Evans, Medical Director, Divison of Vaccine 
Injury Compensation, BHPR, Department of Health and Human Services, 
Health Resources and Services Administration, Room 8A-45, 5600 Fishers 
Lane, Rockville, MD 20857
Phone: 301 443-4998
Fax: 301 443-8196
Email: [email protected]

RIN: 0906-AA55
_______________________________________________________________________




1107.  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 which 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 (NPDB).

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            01/00/02

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: State

Agency Contact: John M. Heyob, Director, Division of Practitioner Data 
Banks, Department of Health and Human Services, Public Health Service, 
Suite 300, 7519 Standish Place, Rockville, MD 20957
Phone: 301 443-2300
Fax: 301 443-6725

RIN: 0906-AA57
_______________________________________________________________________


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


Health Resources and Services Administration (HRSA)



_______________________________________________________________________




1108.  NATIONAL VACCINE INJURY COMPENSATION PROGRAM: REVISIONS 
AND ADDITIONS TO THE VACCINE INJURY TABLE

Priority: Substantive, Nonsignificant

Legal Authority: PL 106-170

CFR Citation: 42 CFR 100

Legal Deadline: None

Abstract: This final rule amends the Vaccine Injury Table (Table) (42 
CFR 100.3), which will have an effect upon petitions for compensation 
under the National Childhood Vaccine Injury Compensation Program 
including the following: (1) amending the Table by adding the injury of 
intussusception to the Table for vaccines containing live, oral, 
rehesus-based rotavirus, a category of rotavirus vaccines; (2) removing 
residual seizure disorder and early onset Hib disease from the Table's 
Qualifications and Aids to Interpretation; (3) removing hemophilus 
influenzae type b polysaccharide vaccines from and adding pneumococcal 
conjugate vaccines to the Table; and (4) changing certain dates of 
coverage under the Table.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Rule                      03/00/02

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Geoffrey Evans, Medical Director, Divison of Vaccine 
Injury Compensation, BHPR, Department of Health and Human Services, 
Health Resources and Services Administration, Room 8A-45, 5600 Fishers 
Lane, Rockville, MD 20857
Phone: 301 443-4998
Fax: 301 443-8196
Email: [email protected]

RIN: 0906-AA58
_______________________________________________________________________




1109.  ADOPTION OF THE INTERIM FINAL RULE AS A FINAL RULE WITH 
AMENDMENTS FOR RICKY RAY HEMOPHILIA

Priority: Substantive, Nonsignificant

Legal Authority: PL 105-369 Sec. 103

CFR Citation: 42 CFR 130

Legal Deadline: None

Abstract: Facilitates petitioning and review process for providing 
compassionate payments to certain individuals with blood clotting 
disorders treated with antihemophilic factor between July 1, 1982 and 
December 31, 1987, and who contracted HIV, certain persons who 
contracted HIV from these individuals, and certain survivors. Ensures 
that payments made to legally incompetent individuals, such as minors, 
are used for their benefit. Responds to public comments on the interim 
final rule (65FR34860) effective July 31, 2000.

[[Page 61603]]

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              05/31/00                    65 FR 34860
Interim Final Rule Comment 
Period End                      06/30/00
Interim Final Rule Effective    07/31/00
Final Rule                      02/00/02

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Thomas C. Croft, Director, Division of Quality 
Assurance, Bureau of Health Professions, HRSA, Department of Health and 
Human Services, Health Resources and Services Administration, Room 8A-
55, Parklawn Building, 5600 Fishers Lane, Rockville, MD 20857
Phone: 301 443-2300

RIN: 0906-AA59
_______________________________________________________________________


Department of Health and Human Services (HHS)         Completed Actions


Health Resources and Services Administration (HRSA)



_______________________________________________________________________




1110. COMPLIANCE ALTERNATIVES FOR PROVISION OF UNCOMPENSATED SERVICES

Priority: Substantive, Nonsignificant

CFR Citation: 42 CFR 124, subpart F

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    09/26/01                    66 FR 49261

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Eulas Dortch
Phone: 301 443-8007
Fax: 301 443-0619
Email: [email protected]

RIN: 0906-AA52
_______________________________________________________________________




1111. FINAL RULE FOR THE HEALTH PROFESSIONS, NURSING, PUBLIC HEALTH, AND 
ALLIED HEALTH TRAINING GRANT PROGRAMS UNDER 42 CFR PARTS 57 AND 58

Priority: Substantive, Nonsignificant

CFR Citation: 42 CFR 57; 42 CFR 58

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    08/27/01                    66 FR 44981

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Steve Tise
Phone: 301 443-2381
Fax: 301 443-8003
Email: [email protected]

RIN: 0906-AA53
_______________________________________________________________________


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


Indian Health Service (IHS)



_______________________________________________________________________




1112. TRIBAL SELF-GOVERNANCE AMENDMENTS

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

RIN: 0917-AA05
_______________________________________________________________________


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


Indian Health Service (IHS)



_______________________________________________________________________




1113. INDIAN CHILD PROTECTION AND FAMILY VIOLENCE PREVENTION ACT MINIMUM 
STANDARDS OF CHARACTER

Priority: Info./Admin./Other

Legal Authority: 25 USC 3201 et seq

CFR Citation: 42 CFR 36

Legal Deadline: None

Abstract: The Indian Health Service (IHS) is proposing to establish 
regulations as mandated by the Indian Child Protection and Family 
Violence Protection Act, Public Law 101-630, 25 U.S.C. 3201 to 3211, 
that prescribe minimum standards of character for individuals whose 
duties and responsibilities involve regular contact with, or control 
over, Indian children.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            03/25/99                    64 FR 14559
NPRM Comment Period End         07/26/99
Final Action                    04/00/02

Regulatory Flexibility Analysis Required: No

Government Levels Affected: Tribal

Agency Contact: Ramona D. Williams, Child Protection Coordinator, 
Department of Health and Human Services, Indian Health Service, Suite 
605, 12300 Twinbrook Parkway, Rockville, MD 20852
Phone: 301 443-1589

RIN: 0917-AA02

[[Page 61604]]

_______________________________________________________________________


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


National Institutes of Health (NIH)



_______________________________________________________________________




1114. NATIONAL INSTITUTES OF HEALTH AIDS RESEARCH LOAN REPAYMENT PROGRAM

Priority: Substantive, Nonsignificant

Legal Authority: 42 USC 216; 42 USC 288-1

CFR Citation: 42 CFR 68

Legal Deadline: None

Abstract: Section 487A of the Public Health Service (PHS) Act creates a 
program through which appropriately qualified health professionals may 
obtain federally funded repayment of educational loans by conducting 
AIDS research as NIH employees.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            01/00/02

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

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
Email: [email protected]

RIN: 0925-AA02
_______________________________________________________________________




1115. UNDERGRADUATE SCHOLARSHIP PROGRAM REGARDING PROFESSIONS NEEDED BY 
THE NIH

Priority: Substantive, Nonsignificant

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

CFR Citation: 42 CFR 68b

Legal Deadline: None

Abstract: Section 487D of the Public Health Service Act, as added by 
the National Institutes of Health Revitalization Act of 1993, creates a 
program offering scholarships, in an amount not to exceed $20,000 per 
year of academic study, to individuals from disadvantaged backgrounds 
who are enrolled as full-time students at accredited institutions 
pursuing academic programs appropriate for careers in professions 
needed by the NIH. For each year of scholarship support, the recipient 
agrees to service (employment) after graduation, at the NIH, for one 
year. Additionally, the individual agrees to at least 10 consecutive 
weeks of service (employment) at the NIH during which the individual is 
attending the educational institution and receiving the NIH 
scholarship. The proposed new regulations will cover this program.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            02/00/02

Regulatory Flexibility Analysis Required: 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
Email: [email protected]

RIN: 0925-AA10
_______________________________________________________________________




1116. NATIONAL CANCER INSTITUTE CLINICAL CANCER EDUCATION PROGRAM

Priority: Info./Admin./Other

Legal Authority: 42 USC 216; 42 USC 285a-1

CFR Citation: 42 CFR 52d

Legal Deadline: None

Abstract: Current regulations relating to the National Cancer Institute 
(NCI) Clinical Cancer Education Program will be amended to update 
various aspects of the regulation.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            02/00/02

Regulatory Flexibility Analysis Required: 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
Email: [email protected]

RIN: 0925-AA17
_______________________________________________________________________




1117. NATIONAL INSTITUTES OF HEALTH LOAN REPAYMENT PROGRAM FOR RESEARCH

Priority: Substantive, Nonsignificant

Legal Authority: 42 USC 216; 42 USC 288-3

CFR Citation: 42 CFR 68d

Legal Deadline: None

Abstract: Regulations will be issued to govern the awarding of 
educational loan repayments to qualified health professionals who agree 
to conduct research as employees of the National Institutes of Health.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            02/00/02

Regulatory Flexibility Analysis Required: 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
Email: [email protected]

RIN: 0925-AA18
_______________________________________________________________________




1118. NIH CENTER GRANTS

Priority: Substantive, Nonsignificant

Legal Authority: 42 USC 216; PL 106-310; PL 106-505; PL 106-525

CFR Citation: 42 CFR 52a

Legal Deadline: None

Abstract: NIH proposes to amend the current center grants regulations 
to reflect new authorities set forth in sections 409C, 452E, 485F and 
445I of the PHS Act. Section 409C concerns centers of excellence 
regarding research on autism; section 485F concerns centers regarding 
research on ``fragile X;'' section 452F concerns centers of excellence 
for research education and training for individuals who are members of 
minority health disparity populations, and section 445I concerns 
centers of excellence in Alzheimer's disease research and treatment.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            02/00/02

Regulatory Flexibility Analysis Required: No

[[Page 61605]]

Small Entities Affected: Governmental Jurisdictions

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
Email: [email protected]

RIN: 0925-AA24
_______________________________________________________________________




1119. NATIONAL INSTITUTES OF HEALTH CLINICS RESEARCH LOAN REPAYMENT 
PROGRAM FOR INDIVIDUALS FROM DISADVANTAGED BACKGROUNDS

Priority: Substantive, Nonsignificant

Legal Authority: 42 USC 216; PL 105-392; PL 106-554

CFR Citation: 42 CFR 68a

Legal Deadline: None

Abstract: NIH proposes to amend the current regulations by revising 
sections 68a.8(a) to reflect the increase in the maximum annual loan 
repayment from $20,000 to $35,000, and other sections to reflect 
expansion of the program to include extramural investigators from 
disadvantaged backgrounds. This action is necessary because of the 
enactment of the Health Professions Education Partnership Act of 1998, 
Public Law 105-392, and enactment of the Consolidated Appropriations 
Act of 2001, Public Law 106-554. Section 410 of Public Law 105-392 
amends section 487E(a) of the PHS Act to increase the maximum annual 
amount.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            02/00/02

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
Email: [email protected]

RIN: 0925-AA25
_______________________________________________________________________




1120. NIH LOAN REPAYMENT PROGRAM FOR MINORITY HEALTH DISPARTIES RESEARCH

Priority: Substantive, Nonsignificant

Legal Authority: 42 USC 216; PL 106-525

CFR Citation: 42 CFR 68f

Legal Deadline: None

Abstract: NIH propses to establish regulations to implement the program 
authorized under section 485G of the PHS Act. Section 103 of the 
Minority Health and Health Disparities Research and Education Act of 
2000 amends the PHS Act by adding a new section 485G which authorizes 
the program.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            02/00/02

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
Email: [email protected]

RIN: 0925-AA26
_______________________________________________________________________




1121. PEDIATRIC RESEARCH LOAN REPAYMENT PROGRAM

Priority: Substantive, Nonsignificant

Legal Authority: 42 USC 216; PL 106-310

CFR Citation: 42 CFR 68f

Legal Deadline: None

Abstract: NIH proposes to establish regulations to implement the 
Pediatric Research Loan Repayment Program authorized under section 487F 
of the PHS Act, as added by Public Law 106-310. Section 1002 of Public 
Law 106-310 amends the PHS Act by adding a new section 487F which 
authorizes the program.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            02/00/02

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
Email: [email protected]

RIN: 0925-AA27
_______________________________________________________________________




1122. NIH TRAINING GRANTS

Priority: Substantive, Nonsignificant

Legal Authority: 42 USC 216; PL 106-310

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 PHS Act. This 
action is necessitated by enactment of the Children's Act of 2000. 
Section 1002 of this act adds a new section 452G that authorizes the 
Director of National Institute of Child Health and Human Development 
(NICHD) in consultation with the Administrator of Health Resources and 
Services Administration (HRSA), to support activities to provide for an 
increase in the number and size of institutional training grants to 
institutions supporting pediatric training.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            01/00/02

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
Email: [email protected]

RIN: 0925-AA28

[[Page 61606]]

_______________________________________________________________________




1123.  NATIONAL INSTITUTES OF HEALTH LOAN REPAYMENT PROGRAM FOR 
CLINICAL RESEARCHERS

Priority: Substantive, Nonsignificant

Legal Authority: 42 USC 216; PL 106-505

CFR Citation: 42 CFR 68f

Legal Deadline: None

Abstract: Section 487F of the Public Health Service Act as added by the 
Public Health Improvement Act (Pub. L. 106-505), provides for repayment 
of the educational loan debt of qualified health professionals who 
agree to conduct clinical research. NIH is proposing to issue 
regulations to govern the administration of this program.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            02/00/02

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
Email: [email protected]

RIN: 0925-AA30
_______________________________________________________________________




1124.  STANDARDS FOR A NATIONAL CHIMPANZEE SANCTUARY SYSTEM

Priority: Substantive, Nonsignificant

Legal Authority: 42 USC 287a-3a

CFR Citation: 42 CFR 8

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

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            02/00/02

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Procurement: This is a procurement-related action for which there is a 
statutory requirement. The agency has not yet determined whether there 
is a paperwork burden associated with this action.

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
Email: [email protected]

RIN: 0925-AA31
_______________________________________________________________________


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


National Institutes of Health (NIH)



_______________________________________________________________________




1125. NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT 
CONTRACEPTION AND INFERTILITY RESEARCH LOAN REPAYMENT PROGRAM

Priority: Substantive, Nonsignificant

Legal Authority: 42 USC 216; 42 USC 288-2

CFR Citation: 42 CFR 68c

Legal Deadline: None

Abstract: Section 487B of the Public Health Service Act creates a 
program through which appropriately qualified health professionals may 
obtain federally funded repayment of education loans by conducting 
research with respect to contraception and/or infertility.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/10/99                    64 FR 69213
Final Rule                      02/00/02

Regulatory Flexibility Analysis Required: 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
Email: [email protected]

RIN: 0925-AA19
_______________________________________________________________________




1126. SCIENTIFIC PEER REVIEW OF RESEARCH GRANT APPLICATIONS AND RESEARCH 
AND DEVELOPMENT CONTRACT PROJECTS

Priority: Substantive, Nonsignificant

Legal Authority: 42 USC 216; 42 USC 282(b)(6); 42 USC 284(c)(3); 42 USC 
289a; 42 USC 290aa-3

CFR Citation: 42 CFR 52h

Legal Deadline: None

Abstract: NIH staff have been reexamining the peer review process as 
part of its reinvention of government initiatives and have found 
ambiguities, misstatements, and voids in the existing regulations. 
These regulations, which govern the first level of review, are being 
amended to reflect current policies and procedures.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/21/00                    65 FR 57132
Final Action                    02/00/02

Regulatory Flexibility Analysis Required: 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
Email: [email protected]

RIN: 0925-AA20

[[Page 61607]]

_______________________________________________________________________


Department of Health and Human Services (HHS)         Completed Actions


National Institutes of Health (NIH)



_______________________________________________________________________




1127. NATIONAL RESEARCH SERVICE AWARDS

Priority: Info./Admin./Other

CFR Citation: 42 CFR 66

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Rule                      05/31/01                    66 FR 29498

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

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

RIN: 0925-AA16
_______________________________________________________________________


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


Office of Public Health and Science (OPHS)



_______________________________________________________________________




1128.  PUBLIC HEALTH SERVICES POLICIES ON RESEARCH MISCONDUCT

Priority: Substantive, Nonsignificant

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

CFR Citation: 42 CFR 93

Legal Deadline: None

Abstract: This Notice of Proposed Rulemaking proposes substantial 
revisions to the existing regulations at 42 CFR part 50, subpart A, 
``Responsibilities of Awardee and Applicant Institutions for Dealing 
With and Reporting Possible Misconduct in Science,'' 54 FR 32449, 
August 8, 1989. The National Institutes of Health Revitalization Act of 
1993 (NIH Act), Public Law 103-43, contains provisions that affect the 
current rule. For example, section 161 of the NIH Act established the 
Office of Research Integrity (ORI) as an independent entity reporting 
to the Secretary, and recent organizational changes have also affected 
the ORI's operations. In addition, the Office of Science and Technology 
Policy (OSTP) published a governmentwide policy that applies to 
federally-funded research and proposals submitted to the Federal 
agencies for research funding, 65 FR 76260, December 6, 2000. The 
proposed revised regulation will implement this OSTP policy, which 
contains a definition of research misconduct and basic guidelines for 
the response of Federal agencies and research institutions to 
allegations of research misconduct. The current regulation, which 
implemented section 493(e) of the Public Health Service Act, would be 
deleted, and a new part 93, subparts A, B, C, D, and E would be added.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            03/00/02
NPRM Comment Period End         05/00/02

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses, Governmental Jurisdictions, 
Organizations

Government Levels Affected: Federal, State

Agency Contact: Gail Gibbons, Department of Health and Human Services, 
Office of Public Health and Science, 5515 Security Lane, Suite 700, 
Rockville, MD 20852
Phone: 301 443-3466
Fax: 301 594-0041

RIN: 0940-AA04
_______________________________________________________________________


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


Office of Public Health and Science (OPHS)



_______________________________________________________________________




1129. 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 Rule                      04/00/02

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses, Governmental Jurisdictions, 
Organizations

Government Levels Affected: State

Agency Contact: Barbara Bullman, Policy Analyst, Department of Health 
and Human Services, Office of Public Health and Science, Suite 700, 
5515 Security Lane, Rockville, MD 20852
Phone: 301 443-5300
Fax: 301 443-5351

Gail Gibbons, Department of Health and Human Services, Office of Public 
Health and Science, 5515 Security Lane, Suite 700, Rockville, MD 20852
Phone: 301 443-3466
Fax: 301 594-0041

RIN: 0940-AA01
_______________________________________________________________________




1130. FEDERAL POLICY (COMMON RULE) FOR THE PROTECTION OF HUMAN SUBJECTS

Priority: Other Significant

Legal Authority: 5 USC 301; 42 USC 289

CFR Citation: 45 CFR 46

Legal Deadline: None

[[Page 61608]]

Abstract: In compliance with the President's Memorandum of March 27, 
1997, this interim final rule would amend the Federal Policy (common 
rule) for the Protection of Human Subjects to add a new section that 
applies only to classified research involving human subjects. The new 
section would modify the Federal Policy by: 1) prohibiting any 
executive branch agency from engaging in classified research involving 
human subjects unless the agency has adopted the Federal Policy and the 
interim final rule; 2) eliminating the availability of waiver of 
informed consent and expedited review for classified research involving 
human subjects; 3) enhancing the informed consent requirements and 
allowing for disclosure of classified information if necessary; and 4) 
changing the composition of the institutional review board (IRB) and 
establishing a process for individual IRB approvals of classified 
research.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              02/00/02

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Dr. Clifford Scharke, Department of Health and Human 
Services, Office of Public Health and Science, Suite 3B01, 6100 
Executive Boulevard, Rockville, MD 20852
Phone: 301 435-5647

RIN: 0940-AA03
_______________________________________________________________________




1131.  PROTECTION OF HUMAN RESEARCH SUBJECTS

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

Legal Authority: 5 USC 301: 42 USC 289(a)

CFR Citation: 45 CFR 46

Legal Deadline: None

Abstract: The Department is proposing to amend subpart B of its human 
subjects protections regulations published on January 17, 2001. Subpart 
B provides additional protections for pregnant women and human fetuses 
involved in research and pertain to human in vitro fertilization. A 
proposed rule was published on July 6, 2001, which would amend the 
January regulations by making the following three modifications:
 (1) Require a father's consent (when the father is readily available) 
for participating in research directed solely at the fetus and that 
does not affect a mother's health.
 (2) Add to the regulations the term ``neonate'' to describe an infant 
that has been delivered but for which viability determination has not 
yet been made.
 (3) Clarify that neonates of uncertain viability may be subjected to 
added risk only if the research is intended to enhance the particular 
neonate's probability of survival to the point of viability.
Public comment was accepted through September 4; the anticipated date 
of the final rule is November 14, 2001.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            07/06/01                    66 FR 73354
NPRM Comment Period End         09/04/01
Final Rule                      12/00/01

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, 200 Independence 
Avenue, SW, Room 733-E, Washington, DC 20201
Phone: 202 260-1587
Fax: 202 205-0493
Email: [email protected]

RIN: 0940-AA05
_______________________________________________________________________


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


Centers for Medicare & Medicaid Services (CMS)



_______________________________________________________________________




1132. MEDICARE AND MEDICAID PROGRAMS; TERMS, DEFINITIONS, AND ADDRESSES: 
TECHNICAL AMENDMENTS (CMS-9877-P)

Priority: Substantive, Nonsignificant

Legal Authority: 42 USC 1302; 42 USC 1395x(v)(1)(A); 42 USC 1395hh

CFR Citation: 42 CFR 400 to 440; 42 CFR 442 to 447; 42 CFR 455; 42 CFR 
456; 42 CFR 462 to 466; 42 CFR 473 to 476; 42 CFR 482 to 489; 42 CFR 
491 to 498

Legal Deadline: None

Abstract: This rule would initiate the rationalization of our system of 
definitions, correct outdated addresses and formulas, clarify which 
steps of the appeals process are binding and which are final, remove 
content that is duplicative or unnecessary, and make other clarifying 
editorial changes.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            02/00/02

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Margaret Teeters, Department of Health and Human 
Services, Centers for Medicare & Medicaid Services, C5-14-03, Division 
of Regulation and Issuances, 7500 Security Boulevard, Balitmore, MD 
21244
Phone: 410 786-4678

RIN: 0938-AH53
_______________________________________________________________________




1133. NATIONAL STANDARD FOR IDENTIFIERS OF HEALTH PLANS (CMS-4145-P)

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

RIN: 0938-AH87
_______________________________________________________________________




1134. END STAGE RENAL DISEASE BAD DEBT PAYMENT (CMS-1126-P)

Priority: Other Significant

Legal Authority: Sec 110 of the Social Security Act; sec 1812(d) of the 
Social Security Act; sec 1814(b) of the Social Security Act; sec 1815 
of the Social Security Act; sec 1833(a) of the Social Security Act; sec 
1833(i) of the Social Security Act; sec 1833(n) of the Social Security 
Act; sec 1861(v) of the Social Security Act; sec 1866 of the Social 
Security Act; sec 1871 of the Social

[[Page 61609]]

Security Act; sec 1881 of the Social Security Act; sec 1883 of the 
Social Security Act; 42 USC 1302; 42 USC 1395f(b); 42 USC 1395g; 42 USC 
1395(a); 42 USC 1395(i); 42 USC 1395(n); 42 USC 1395x(v); 42 USC 
1395cc; 42 USC 1395hh; 42 USC 1395rr; 42 USC 1395tt

CFR Citation: 42 CFR 413.178

Legal Deadline: None

Abstract: This rule would remove the cap on end stage renal disease bad 
debts as stated in 42 CFR 413.178, which limits reimbursement of 
Medicare bad debts to the end stage renal disease facility's 
unrecovered costs. With respect to hospital-based providers, this 
regulation permits clearer distinctions to be made between various 
types of services, and ensures that these services will be paid for in 
an appropriate manner.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            03/00/02

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Katie Walker, Department of Health and Human Services, 
Centers for Medicare & Medicaid Services, C5-03-03, 7500 Security 
Boulevard, Baltimore, MD 21244-1850
Phone: 410 786-7278

RIN: 0938-AK02
_______________________________________________________________________




1135. FIRE SAFETY REQUIREMENTS FOR RNHCI, ASC, HOSPICES, PACE, 
HOSPITALS, AND LONG-TERM CARE FACILITIES AND ICFS FOR THE MENTALLY 
RETARDED (CMS-3047-P)

Priority: Substantive, Nonsignificant

Legal Authority: 42 USC 1302; 42 USC 1395hh

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

Legal Deadline: None

Abstract: This rule would adopt the 2000 edition of the National Fire 
Protection Association's Life Safety Code as the fire safety standards 
for RNHCI, ASC, and Hospices that provide in-patient services, PACE, 
Hospitals, Long-Term Care Facilities, and ICFs for the Mentally 
Retarded.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            10/26/01                    66 FR 54179
Final Rule                       To Be                       Determined

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Tamara Syrek, Health Insurance Specialist, Department 
of Health and Human Services, Centers for Medicare & Medicaid Services
Phone: 410 786-3529

RIN: 0938-AK35
_______________________________________________________________________




1136. MEDICAL DEVICES COVERAGE DECISIONS RELATED TO HEALTH CARE 
TECHNOLOGY (CMS-3059-P)

Priority: Other Significant. Major under 5 USC 801.

Unfunded Mandates: Undetermined

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

CFR Citation: 42 CFR 405.207

Legal Deadline: None

Abstract: This rule exemption would permit coverage for, and payment, 
of routine patient care costs associated with certain approved clinical 
trials of delays subject to the investigational devices. This would 
also include costs due to medical complications associated with 
participating in approved clinical trials.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            03/00/02

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Marty Abeln, Department of Health and Human Services, 
Centers for Medicare & Medicaid Services, Centers for Medicare 
Management, 7500 Security Boulevard, Baltimore, MD 21244-1850
Phone: 410 786-1032

Sharon Hippler, Office of Clinical Standards and Quality, Department of 
Health and Human Services, Centers for Medicare & Medicaid Services, 
7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-4633

RIN: 0938-AK43
_______________________________________________________________________




1137. MEDICARE PROGRAM; REPORTING AND REPAYMENT OF OVERPAYMENTS (CMS-
6011-P)

Priority: Other Significant

Legal Authority: Sec 1102 of the Social Security Act; Sec 1870 of the 
Social Security Act; Sec 1871 of the Social Security Act; 42 USC 1302 
of the Social Security Act; 42 USC 1395gg of the Social Security Act; 
42 USC 1395hh of the Social Security Act

CFR Citation: 42 CFR 401.310

Legal Deadline: None

Abstract: This proposed rule would modify a notice of proposed 
rulemaking published on March 25, 1998. That notice proposed to amend 
regulations governing liability for overpayments to providers, 
suppliers, and individuals.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            02/00/02

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Barbara Wright, Health Insurance Specialist, Department 
of Health and Human Services, Centers for Medicare & Medicaid Services, 
C3-14-00, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-4292

RIN: 0938-AK45
_______________________________________________________________________




1138. HEALTH INSURANCE REFORM: STANDARDS FOR ELECTRONIC CLAIMS 
ATTACHMENTS (CMS-0050-P)

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

RIN: 0938-AK62
_______________________________________________________________________




1139. HEALTH INSURANCE REFORM: MODIFICATIONS TO STANDARDS FOR ELECTRONIC 
TRANSACTIONS (CMS-0003-P)

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

RIN: 0938-AK64

[[Page 61610]]

_______________________________________________________________________




1140. PROSPECTIVE PAYMENT SYSTEM FOR LONG-TERM CARE HOSPITALS FOR FY 
2003 (CMS-1177-P)

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

RIN: 0938-AK69
_______________________________________________________________________




1141. MODIFICATIONS TO MEDICARE MANAGED CARE RULES BASED ON PROVISIONS 
OF BIPA AND TECHNICAL CORRECTIONS (CMS-1180-P)

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

RIN: 0938-AK71
_______________________________________________________________________




1142. REVISIONS TO TRANSACTION AND CODE SET STANDARDS FOR ELECTRONIC 
TRANSACTIONS (CMS-0005-P)

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

RIN: 0938-AK76
_______________________________________________________________________




1143. ORGAN PROCUREMENT ORGANIZATION CONDITION FOR COVERAGE (CMS-3064-
IFC)

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

RIN: 0938-AK81
_______________________________________________________________________




1144. QUALIFICATION REQUIREMENTS FOR DIRECTORS OF LABORATORIES 
PERFORMING HIGH COMPLEXITY TESTING (CMS-2094-P)

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

Legal Authority: USPHSA, sec 353

CFR Citation: 42 CFR 493.1443

Legal Deadline: None

Abstract: This rule would revise and expand the qualification 
requirements by which an individual with a doctoral degree may qualify 
to serve as a director of a laboratory that performs high complexity 
testing.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            02/00/02

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Cecelia Hinkel, Health Insurance Specialist, Department 
of Health and Human Services, Centers for Medicare & Medicaid Services
Phone: 410 786-3347

RIN: 0938-AK83
_______________________________________________________________________




1145.  STATE ALLOTMENTS FOR PAYMENT OF MEDICARE PART B PREMIUMS 
FOR QUALIFIED INDIVIDUALS; FEDERAL FISCAL YEAR 2002 (CMS-2087-PN)

Priority: Other Significant

Legal Authority: 42 USC 1396a(a)(10)(E); 42 USC 1396x

CFR Citation: None

Legal Deadline: None

Abstract: This notice proposes state allotments that would be available 
for state agencies to pay Medicare part B premiums for certain 
eligibility groups for Federal Fiscal Year 2002.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Notice                          02/00/02

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: State

Federalism:  Undetermined

Agency Contact: Robert Nakielny, Center for Medicaid and State 
Operations, Department of Health and Human Services, Centers for 
Medicare & Medicaid Services, S2-14-26, 7500 Security Boulevard, 
Baltimore, MD 21244-1850
Phone: 410 786-4466

RIN: 0938-AK91
_______________________________________________________________________




1146.  HOME HEALTH PROSPECTIVE PAYMENT SYSTEM REFINEMENTS (CMS-
1161-P)

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

RIN: 0938-AK93
_______________________________________________________________________




1147.  MEDICAID MANAGED CARE (CMS-2104-F)

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

RIN: 0938-AK96
_______________________________________________________________________




1148.  MEDICAID UPPER PAYMENT LIMIT FOR NON-STATE GOVERNMENT-
OWNED OR OPERATED HOSPITALS (CMS-2134-P)

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

RIN: 0938-AL05
_______________________________________________________________________




1149.  HOME HEALTH PROSPECTIVE PAYMENT SYSTEM RATE UPDATE FOR 
FY 2003 (CMS-1198-NC)

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

RIN: 0938-AL16
_______________________________________________________________________




1150.  REQUIREMENTS FOR PAID FEEDING ASSISTANTS IN LONG-TERM 
CARE FACILITIES (CMS-2131-P)

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

RIN: 0938-AL18
_______________________________________________________________________




1151.  HOSPITAL OUTPATIENT PROSPECTIVE PAYMENT SYSTEM FOR 
CALENDAR YEAR 2003 (CMS-1206-P)

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

RIN: 0938-AL19
_______________________________________________________________________




1152.  PROSPECTIVE PAYMENT SYSTEM AND CONSOLIDATED BILLING FOR 
SKILLED NURSING FACILITIES-UPDATE FOR FY 2003 (CMS-1202-P)

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

RIN: 0938-AL20
_______________________________________________________________________




1153.  REVISIONS TO PAYMENT POLICIES UNDER THE PHYSICIAN FEE 
SCHEDULE FOR CALENDAR YEAR 2003 (CMS-1204-P)

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

RIN: 0938-AL21

[[Page 61611]]

_______________________________________________________________________




1154.  HOSPITAL INPATIENT REHABILITATION PROSPECTIVE PAYMENT 
SYSTEM FOR FY 2003 (CMS-1205-P)

 Regulatory Plan: This entry is Seq. No. 56 in part II of this issue of 
the Federal Register.

RIN: 0938-AL22
_______________________________________________________________________




1155.  HOSPITAL INPATIENT PROSPECTIVE PAYMENT SYSTEM FOR FY 
2003 (CMS-1203-P)

 Regulatory Plan: This entry is Seq. No. 57 in part II of this issue of 
the Federal Register.

RIN: 0938-AL23
_______________________________________________________________________




1156.  INITIATIVE TO ENDORSE PRESCRIPTION DRUG DISCOUNT 
PROGRAMS (CMS-4027-P)

 Regulatory Plan: This entry is Seq. No. 58 in part II of this issue of 
the Federal Register.

RIN: 0938-AL28
_______________________________________________________________________


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


Centers for Medicare & Medicaid Services (CMS)



_______________________________________________________________________




1157. HEALTH INSURANCE REFORM: STANDARD UNIQUE HEALTH CARE PROVIDER 
IDENTIFIER (CMS-0045-F)

 Regulatory Plan: This entry is Seq. No. 59 in part II of this issue of 
the Federal Register.

RIN: 0938-AH99
_______________________________________________________________________




1158. SECURITY STANDARDS (CMS-0049-F)

 Regulatory Plan: This entry is Seq. No. 60 in part II of this issue of 
the Federal Register.

RIN: 0938-AI57
_______________________________________________________________________




1159. NATIONAL STANDARD EMPLOYER IDENTIFIER (CMS-0047-F)

 Regulatory Plan: This entry is Seq. No. 61 in part II of this issue of 
the Federal Register.

RIN: 0938-AI59
_______________________________________________________________________




1160. MEDICARE PROGRAM; COVERAGE AND ADMINISTRATIVE POLICIES FOR 
CLINICAL DIAGNOSTIC LABORATORY TESTS (CMS-3250-F)

Priority: Other Significant. Major under 5 USC 801.

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

Legal Authority: PL 105-33, sec 4554(b)(1)

CFR Citation: 42 CFR ch 410

Legal Deadline: Final, Statutory, January 1, 1999, BBA Section 4106.

Abstract: This rule would establish national coverage and 
administrative policies for clinical diagnostic laboratory services 
payable under Medicare part B to promote Medicare program integrity and 
national uniformity, and simplify administrative requirements for 
clinical diagnostic laboratory services. A Negotiated Rulemaking 
Committee (the Committee) developed the proposed policies as directed 
by section 4554(b)(1) of the Balanced Budget Act of 1997 (the BBA).

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Notice of Intent To Negotiate   06/03/98                    63 FR 30166
Final Action                    02/00/02

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected: Businesses

Government Levels Affected: State, Local, Tribal

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

Agency Contact: Jacqueline Sheridan, Office of Clinical Standards and 
Quality, Department of Health and Human Services, Centers for Medicare 
& Medicaid Services, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-4635

RIN: 0938-AI92
_______________________________________________________________________




1161. RURAL HEALTH CLINICS: AMENDMENTS TO PARTICIPATION REQUIREMENTS AND 
PAYMENT PROVISIONS, AND ESTABLISHMENT OF A QUALITY ASSESSMENT AND 
IMPROVEMENT PROGRAM (CMS-1910-F)

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 amends the requirements for certification and 
payment for rural health clinics (RHCs), as required by section 4205 of 
the Balanced Budget Act of 1997 (BBA 1997). It includes new refinements 
of what constitutes 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 can continue to be 
approved as Medicare RHCs in areas no longer designated as medically 
underserved; and include recent statutory provisions that provide a 
temporary waiver of certain nonphysician practitioner staffing 
requirements. It imposes payment limits on provider based RHCs, and 
would prohibit the use of RHC space or equipment, and other RHC 
resources by another Medicare entity. The rule also requires 
establishment of a quality assessment and performance improvement 
program.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            02/28/00                    65 FR 10450
Final Action                    03/00/02

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: Federal

Agency Contact: David Worgo, Center for Health Plans and Providers, 
Division of Integrated Services, Department of Health and Human 
Services, Centers for Medicare & Medicaid Services, C4-15-18, 7500 
Security Boulevard, Baltimore, MD 21244-1850
Phone: 410 786-5919

RIN: 0938

[[Page 61612]]

-AJ17
_______________________________________________________________________




1162. FEE SCHEDULE FOR PAYMENT OF AMBULANCE SERVICES AND REVISIONS TO 
THE PHYSICIAN'S CERTIFICATION REQUIREMENTS FOR COVERAGE OF NONEMERGENCY 
AMBULANCE SERVICES (CMS-1002-FC)

 Regulatory Plan: This entry is Seq. No. 62 in part II of this issue of 
the Federal Register.

RIN: 0938-AK30
_______________________________________________________________________




1163. HOSPITAL CONDITIONS OF PARTICIPATION: QUALITY ASSESSMENT AND 
PERFORMANCE IMPROVEMENTS (CMS-3050-F)

Priority: Other Significant

Legal Authority: 42 USC 1302; 42 USC 1395hh

CFR Citation: 42 CFR 482.21

Legal Deadline: None

Abstract: This rule requires hospitals to develop and maintain a 
quality assessment and performance improvement (QAPI) program. The QAPI 
focuses the providers' efforts on the actual care delivered to 
patients, the performance of the hospital as an organization, and the 
impact of treatment furnished by the hospital on the health status of 
its patients. In addition, QAPI entails all activities required for 
measuring quality of care and maintaining it at acceptable levels. 
Performance improvement activities aim to improve overall performance 
assuming there is no permanent threshold for good performance. Under a 
performance improvement framework, hospitals will continuously study 
and improve the processes of healthcare and delivery of service.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/19/97                    62 FR 66725
NPRM Comment Period End         02/17/98
Final Action                    02/00/02

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: State

Agency Contact: Stephanie Dyson, Health Insurance Specialist, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, S3-02-01, 7500 Security Boulevard, Baltimore, MD 
21244
Phone: 410 786-9226

RIN: 0938-AK40
_______________________________________________________________________




1164. PAYMENT FOR UPGRADED DURABLE MEDICAL EQUIPMENT (CMS-1084-P)

Priority: Other Significant

Legal Authority: Not Yet Determined

CFR Citation: 42 CFR 414

Legal Deadline: None

Abstract: This rule amends the Medicare regulations to permit Medicare 
suppliers to furnish certain upgraded durable medical equipment on an 
assignment basis. Medicare payment will be made to suppliers as if the 
DME were without the upgraded features.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            04/27/00                    65 FR 24666
Final Action                    01/00/02

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: William J. Long, Department of Health and Human 
Services, Centers for Medicare & Medicaid Services, C4-12-18, Center 
for Health Plans and Providers, 7500 Security Boulevard, Baltimore, MD 
21228
Phone: 410 786-5655
Email: [email protected]

RIN: 0938-AK50
_______________________________________________________________________




1165. PROSPECTIVE PAYMENT SYSTEM FOR HOSPITAL OUTPATIENT SERVICES: 
CRITERIA FOR ESTABLISHING NEW PASS-THROUGH CATEGORIES FOR MEDICAL 
DEVICES (CMS-1179-IFC)

Priority: Other Significant

Legal Authority: 42 USC 1395l; BIPA 2000

CFR Citation: 42 CFR 419

Legal Deadline: None

Abstract: This rule implements the requirement of the BIPA to establish 
criteria for new categories of medical devices for transitional pass-
through payment under the outpatient prospective payment system.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule with Comment 
Period                          11/02/01                    66 FR 55850
Final Rule                      09/00/02

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Nancy Edwards, Center for Medicare Mangement, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, 7500 Security Boulevard, Baltimore, MD 21244-1850
Phone: 410 786-0378
Email: [email protected]

RIN: 0938-AK59
_______________________________________________________________________




1166.  MODIFICATIONS TO MANAGED CARE RULES BASED ON PAYMENT 
PROVISIONS IN BIPA AND TECHNICAL CORRECTIONS (CMS-1181-F)

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

Legal Authority: Secs 601-605 of BIPA; Secs 607-608 of BIPA; Secs 611-
613 of BIPA; Secs 619-621 of BIPA; Sec 623 of BIPA; Sec 634 of BIPA; 
...

CFR Citation: Not Yet Determined

Legal Deadline: None

Abstract: This regulation implements certain technical and minor 
changes of the provisions of sections 601 to 634 of the Medicare 
Payment provisions of the Medicare, Medicaid & SCHIP Benefits and 
Improvement Act (BIPA) of 2000. It is significant because although the 
changes mandated by BIPA are minor and technical in nature, they 
involve updates to payment rates.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Action                    12/00/01

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Alfred G. D'Alberto, Office of Managed Care, Department 
of Health and Human Services, Centers for Medicare & Medicaid Services, 
S3-02-01, 7500 Security Boulevard, Baltimore, MD 21244-1850
Phone: 410 786-1100

RIN: 0938-AK90

[[Page 61613]]

_______________________________________________________________________


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


Centers for Medicare & Medicaid Services (CMS)



_______________________________________________________________________




1167. ``WITHOUT FAULT'' AND BENEFICIARY WAIVER OF RECOVERY AS IT APPLIES 
TO MEDICARE OVERPAYMENT LIABILITY (CMS-6007-F)

Priority: Substantive, Nonsignificant

Legal Authority: 42 USC 1395gg; Sec 1870 of the Social Security Act

CFR Citation: 42 CFR 401; 42 CFR 466.86; 42 CFR 466.94; 42 CFR 473.14; 
42 CFR 403.310; 42 CFR 405; 42 CFR 410.1; 42 CFR 411.23; 42 CFR 411.28; 
42 CFR 413.20; 42 CFR 413.153; 42 CFR 447.31

Legal Deadline: None

Abstract: This rule would amend the Medicare regulations to clarify our 
interpretation of ``without fault'' as it applies to physician, 
provider, supplier, and beneficiary liability for overpayments. This 
definition would result in greater uniformity of determinations by 
carriers and intermediaries. Additionally, this rule would amend the 
Medicare regulations governing liability for overpayments to eliminate 
application of certain regulations of the Social Security 
Administration and to replace them with CMS regulations more specific 
to circumstances involving Medicare overpayments.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            03/25/98                    63 FR 14506


Next Action Undetermined

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Barbara Wright, Health Insurance Specialist, Department 
of Health and Human Services, Centers for Medicare & Medicaid Services, 
C3-14-00, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-4292

RIN: 0938-AD95
_______________________________________________________________________




1168. REVISION OF MEDICARE/MEDICAID HOSPITAL CONDITIONS OF PARTICIPATION 
(CMS-3745-F)

Priority: Other Significant

Legal Authority: 42 USC 1395x; 42 USC 1302; 42 USC 1395(cc); 42 USC 
1395hh; 42 USC 13206-8

CFR Citation: 42 CFR 416; 42 CFR 482; 42 CFR 485; 42 CFR 489

Legal Deadline: None

Abstract: This rule will revise the requirements that hospitals must 
meet to participate in the Medicare and Medicaid programs. The revised 
requirements focus on patient care and the outcomes of that care, 
reflect a cross-functional view of patient treatment, encourage 
flexibility in meeting quality standards, and eliminate unnecessary 
procedural requirements. These changes are necessary to reflect 
advances in health care practices since the requirements were last 
revised in 1986.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/19/97                    62 FR 66726
NPRM Comment Period End         03/20/98


Next Action Undetermined

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses, Organizations

Government Levels Affected: None

Federalism:  Undetermined

Agency Contact: Stephanie Dyson, Health Insurance Specialist, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, S3-02-01, 7500 Security Boulevard, Baltimore, MD 
21244
Phone: 410 786-9226

RIN: 0938-AG79
_______________________________________________________________________




1169. HOME HEALTH AGENCY (HHA) CONDITIONS OF PARTICIPATION (HCMS-3819-
FC)

Priority: Other Significant

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

CFR Citation: 42 CFR 484

Legal Deadline: None

Abstract: This rule will revise home health agency conditions of 
participation to center on the patient, using outcome-oriented 
measures. Most of the current HHA conditions of participation have 
remained unchanged since home health services became a Medicare benefit 
in 1966. Some limited modifications have been made over the years to 
comply with legislative changes. As a result, most of the conditions of 
participation continue to be structure- and process-oriented.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            03/10/97                    62 FR 11005
NPRM Comment Period End         06/09/97


Next Action Undetermined

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected: Businesses, Organizations

Government Levels Affected: None

Federalism:  Undetermined

Agency Contact: Janice Stevenson, Office of Clinical Standards and 
Quality, Department of Health and Human Services, Centers for Medicare 
& Medicaid Services, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-4882

Rachael Weinstein, Health Insurance Specialist, Department of Health 
and Human Services, Centers for Medicare & Medicaid Services, 7500 
Security Boulevard, Baltimore, MD 21244
Phone: 410 786-6775

RIN: 0938-AG81
_______________________________________________________________________




1170. END STAGE RENAL DISEASE (ESRD) CONDITIONS FOR COVERAGE (CMS-3818-
P) (SECTION 610 REVIEW)

Priority: Other Significant

Legal Authority: 42 USC 1395rr

CFR Citation: 42 CFR 400; 42 CFR 405; 42 CFR 406; 42 CFR 409; 42 CFR 
410; 42 CFR 412; 42 CFR 413; 42 CFR 414; 42 CFR 489; 42 CFR 494

Legal Deadline: None

Abstract: This proposed rule would revise the current conditions for 
coverage for end stage renal disease (ESRD) facilities approved to 
provide ESRD service under Medicare. It would update the conditions to 
reflect developments in technology and equipment, emphasize the total 
patient experience and develop performance expectations for the 
facility that result in quality, comprehensive care for the dialysis 
patient.

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Governmental Jurisdictions, Businesses, 
Organizations

[[Page 61614]]

Government Levels Affected: None

Agency Contact: Robert Miller, Department of Health and Human Services, 
Centers for Medicare & Medicaid Services, S3-02-01, Office of Clinical 
Standards and Quality, 7500 Security Boulevard, Baltimore, MD 21244-
1850
Phone: 410 786-6797

RIN: 0938-AG82
_______________________________________________________________________




1171. CRITERIA FOR APPROVAL OF FACILITIES TO PERFORM COVERED HEART, 
LIVER, LUNG, PANCREAS AND INTESTINAL TRANSPLANTS (CMS-3835-P)

Priority: Other Significant

Legal Authority: 42 USC 1302; 42 USC 1395hh

CFR Citation: 42 CFR 482

Legal Deadline: None

Abstract: The rule establishes conditions of participation for 
facilities to perform Medicare-covered transplants.

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses, Organizations

Government Levels Affected: None

Agency Contact: Marty Abeln, Department of Health and Human Services, 
Centers for Medicare & Medicaid Services, Centers for Medicare 
Management, 7500 Security Boulevard, Baltimore, MD 21244-1850
Phone: 410 786-1032

Kathy Linstromberg, Department of Health and Human Services, Centers 
for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, 
MD 21244
Phone: 410 786-8279

Eva Fung, Health Insurance Specialist, Department of Health and Human 
Services, Centers for Medicare & Medicaid Services, S3-06-6, 7500 
Security Boulevard, Baltimore, MD 21244-1850
Phone: 410 786-7539

RIN: 0938-AH17
_______________________________________________________________________




1172. HOSPICE CARE-CONDITIONS OF PARTICIPATION (CMS-3844-P)

Priority: Other Significant

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

CFR Citation: 42 CFR 418

Legal Deadline: None

Abstract: This rule would revise the Medicare conditions of 
participation for hospices to help ensure the provision of quality care 
through an emphasis on patient-centered outcomes. Areas of change would 
include, among others, assessment of patient needs, clarification of 
physician roles, coordination of care for hospice patients residing in 
nursing homes, clarification of nursing roles, patient rights, and 
provision of services.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                             To Be                       Determined

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected: Businesses, Organizations

Government Levels Affected: None

Federalism:  Undetermined

Agency Contact: Mary Rossi Coajou, Health Insurance Specialist, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-6051

Rachael Weinstein, Health Insurance Specialist, Department of Health 
and Human Services, Centers for Medicare & Medicaid Services, 7500 
Security Boulevard, Baltimore, MD 21244
Phone: 410 786-6775

RIN: 0938-AH27
_______________________________________________________________________




1173. REQUIREMENTS FOR ESTABLISHING AND MAINTAINING MEDICARE BILLING 
PRIVILEGES (CMS-6002-P)

Priority: Other Significant

Legal Authority: 42 USC 1302; 42 USC 1395hh

CFR Citation: 42 CFR 424

Legal Deadline: None

Abstract: This rule would establish a requirement that all providers 
and suppliers (other than physicians who have entered into a private 
contract with a beneficiary) must complete an enrollment form, submit 
specified information to us, and periodically update and certify the 
accuracy of the enrollment information in order to receive and maintain 
billing privileges in the Medicare program. The information must 
clearly identify the provider or supplier and its place of business, 
provide documentation that it is qualified to perform the services for 
which it is billing, and assure that it is not currently excluded from 
the Medicare program. If we determine the information submitted is 
incomplete, invalid, or insufficient to meet Medicare requirements, we 
would reject, deny, inactivate, or revoke billing privileges.

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: None

Additional Information: Formerly known as HCFA-1023-P

Agency Contact: Michael Collett, OFM, Department of Health and Human 
Services, Centers for Medicare & Medicaid Services, 7500 Security 
Boulevard, Baltimore, MD 21244
Phone: 410 786-6121

RIN: 0938-AH73
_______________________________________________________________________




1174. UPDATE OF RATESETTING METHODOLOGY, PAYMENT RATES AND THE LIST OF 
COVERED SURGICAL PROCEDURES FOR AMBULATORY SURGICAL CENTERS (CMS-1885-
FC)

Priority: Other Significant. Major under 5 USC 801.

Legal Authority: 42 USC 13951(i)(2)(A)

CFR Citation: 42 CFR 416.61(b); 42 CFR 416.65(a)(4); 42 CFR 416.65(c); 
42 CFR 416.120(c)(1); 42 CFR 416.125; 42 CFR 416.130; 42 CFR 
416.140(a); 42 CFR 416.140(b); 42 CFR 488.1

Legal Deadline: None

Abstract: The final rule will update the criteria for determining which 
surgical procedures can be appropriately and safely performed in an 
Ambulatory Surgical Center (ASC); make additions to and deletions from 
the current list of Medicare covered ASC procedures based on the 
revised criteria; rebase the ASC payment rates using charge and 
utilization data collected by a 1994

[[Page 61615]]

survey of ASCs; refine the ratesetting methodology that was implemented 
by a final notice published on February 8, 1990 in the Federal 
Register; require that ASC payment, coverage and wage index updates be 
implemented annually on January 1, rather than having these updates 
occur randomly throughout the year; establish a payment rate for 
Extracorporeal Shock Wave Lithotripsy; reduce regulatory burden; and 
make several technical policy changes.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/12/98                    63 FR 32290


Next Action Undetermined

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Bob Cereghino, Program Analyst, Department of Health 
and Human Services, Centers for Medicare & Medicaid Services, C4-03-06, 
7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-4645

RIN: 0938-AH81
_______________________________________________________________________




1175. MEDICAL CHILD SUPPORT AND HEALTH INSURANCE COVERAGE OF DEPENDENT 
CHILDREN (CMS-2081-P)

Priority: Substantive, Nonsignificant

Legal Authority: 42 USC 1302; 42 USC 1396(a)(25); 42 USC 1396(a)(45); 
42 USC 1396(a)(60); 42 USC 1396(o); 42 USC 1396g-1; 42 USC 1396(k)

CFR Citation: 42 CFR 433.135; 42 CFR 433.137; 42 CFR 433.170

Legal Deadline: None

Abstract: This rule would require States to provide assurances that 
laws relating to medical child support have satisfactorily been 
implemented in accordance with the Social Security Act (the Act). This 
requirement would implement section 13623 of the Omnibus Budget 
Reconciliation Act of 1993 (Pub. L. 103-66), commonly cited as OBRA 
1993. The medical child support laws that the States must have in 
effect are set forth in section 1908 of the Act. These laws would 
impose requirements on insurers, employers, and State Medicaid agencies 
that would result in greater enrollment opportunities for children, 
facilitate the filing of claims by custodial parents, and establish new 
payment disbursement criteria.

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses, Governmental Jurisdictions

Government Levels Affected: State

Agency Contact: Sue Knefley, Center for Medicaid and State Operations, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-0488

RIN: 0938-AI21
_______________________________________________________________________




1176. SURETY BOND REQUIREMENTS FOR COMPREHENSIVE OUTPATIENT 
REHABILITATION FACILITIES, REHABILITATION AGENCIES (CMS-6005-P)

Priority: Other Significant

Legal Authority: 42 USC 1302; 42 USC 1395x(p); 42 USC 1395x(v); 42 USC 
1395hh; 42 USC 1395x(cc)(2); 42 USC 1395x(p)

CFR Citation: 42 CFR 405; 42 CFR 413; 42 CFR 489

Legal Deadline: None

Abstract: This rule would require comprehensive outpatient 
rehabilitation facilities and rehabilitation agencies to furnish us 
with a surety bond on a continuing basis in order to participate in the 
Medicare program, in accordance with provisions of the Balanced Budget 
Act of 1997 (Pub. L. 105-33).

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Ralph Goldberg, Division of Provider and Supplier 
Enrollment, Department of Health and Human Services, Centers for 
Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, MD 
21244
Phone: 410 786-4870
Email: [email protected]

RIN: 0938-AI48
_______________________________________________________________________




1177. APPEALS OF CARRIER DETERMINATION THAT A SUPPLIER FAILS TO MEET THE 
REQUIREMENTS FOR MEDICARE BILLING PRIVILEGES (CMS-6003-F)

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 rule would establish an administrative appeal process 
whereby suppliers can request an appeal for a determination that 
affects their Medicare part B billing number. The purpose of this rule 
is to update and clarify our policy and extend administrative appeal 
rights to all current and prospective suppliers who are denied 
enrollment in the Medicare program or whose Medicare billing privileges 
are revoked. This rule does not apply to those suppliers covered under 
the appeals provisions for our regulations at 42 CFR 498.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            10/25/99                    64 FR 57431


Next Action Undetermined

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Charles Waldhauser, Division of Provider/Supplier 
Enrollment, Department of Health and Human Services, Centers for 
Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, MD 
21244-1850
Phone: 410 786-6140

Yvonne West, Health Insurance Specialist, Department of Health and 
Human Services, Centers for Medicare & Medicaid Services, 7500 Security 
Blvd., Baltimore, MD 21244
Phone: 410 786-6479

RIN: 0938-AI49
_______________________________________________________________________




1178. ADVANCE REFUNDING OF DEBT AND METHODOLOGY FOR REPAYMENT OF LOAN 
(CMS-1777-P)

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

Unfunded Mandates: Undetermined

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

[[Page 61616]]

CFR Citation: 42 CFR 413

Legal Deadline: None

Abstract: This rule would amend current regulations to clarify our 
policies regarding the treatment of interest expense. The rule would 
require that, when only part of the interest on a loan is allowable, 
repayment would be made first to that portion of the loan on which 
expense is allowable. This rule would also clarify how this policy is 
to be applied in situations in which there are multiple loans, and one 
or more of the loans are not related to patient care. In addition, we 
would define the allowable costs associated with advance refunding of 
debt, and clarify the treatment of revenue and expenses.

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: None

Agency Contact: Ann Pash, Center for Medicare Management,, Department 
of Health and Human Services, Centers for Medicare & Medicaid Services, 
7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-4516
Email: [email protected]

RIN: 0938-AI75
_______________________________________________________________________




1179. MEDICARE COVERAGE OF, AND PAYMENT FOR, BONE MASS MEASUREMENTS 
(CMS-3004-F)

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

Unfunded Mandates: Undetermined

Legal Authority: 42 USC 1302; 42 USC 1395hh; 42 USC 1395(rr)1; 42 USC 
4106

CFR Citation: 42 CFR 410; 42 CFR 414

Legal Deadline: Other, Statutory, July 1, 1998, BBA Section 4106.

Abstract: This final responds to public comments we received on an 
interim final rule that set forth uniform coverage of, and payment for, 
bone mass measurements for qualified Medicare beneficiaries for 
services furnished on or after July 1, 1998. It implements provisions 
in section 4106(a) of the Balanced Budget Act of 1997.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              06/24/98                    63 FR 34320


Next Action Undetermined

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Federalism:  Undetermined

Agency Contact: William Larson, Office of Communications and Operations 
Support, Department of Health and Human Services, Centers for Medicare 
& Medicaid Services, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-4639

RIN: 0938-AI89
_______________________________________________________________________




1180. COVERAGE OF RELIGIOUS NON-MEDICAL HEALTH CARE INSTITUTIONS (CMS-
1909-F)

Priority: Substantive, Nonsignificant

Legal Authority: 42 USC 1395i-5; 42 USC 1395x(e); 42 USC 1395x(y); 42 
USC 1395x(ss); 42 USC 1302

CFR Citation: 42 CFR 403; 42 CFR 440.170; 42 CFR 488.2; 42 CFR 488.6; 
42 CFR 489.102; 42 CFR 412.90; 42 CFR 412.98; 42 CFR 431.610; 42 CFR 
440.155; 42 CFR 442.12; 42 CFR 456.351; 42 CFR 456.601; 42 CFR 466.1

Legal Deadline: Final, Statutory, July 1, 1998, BBA, Section 4454(d).

Abstract: This rule implements section 4454 of the Balanced Budget Act 
of 1997 (BBA 1997), which amended section 1861 of the Social Security 
Act (the Act) and added a new section 1821 to the Act. Section 4454 of 
BBA 1997 removed all references to Christian Science and Christian 
sanatoria from the Act and substituted religious nonmedical health care 
institutions in their place. This change permits any qualified 
religious, nonmedical, health care institution to apply for payment for 
furnishing nonmedical services under Medicare. Section 4454 also 
authorizes payment for such services as an option benefit under State 
Medicaid plans. The rule sets forth minimum requirements and conditions 
of participation to qualify as a religious nonmedical health care 
institution for purposes of receiving payment for services furnished 
under Medicare and Medicaid.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              11/30/99                    64 FR 67028


Next Action Undetermined

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: None

Federalism:  Undetermined

Agency Contact: Jean Marie Moore, Center for Health Plans and 
Providers, Department of Health and Human Services, Centers for 
Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, MD 
21244
Phone: 410 786-3508

RIN: 0938-AI93
_______________________________________________________________________




1181. EXTERNAL QUALITY REVIEW OF MEDICAID MANAGED CARE ORGANIZATIONS 
(CMS-2015-F)

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

Unfunded Mandates: Undetermined

Legal Authority: 42 USC 1302

CFR Citation: 42 CFR 438

Legal Deadline: None

Abstract: This rule implements section 1932(c) of the Social Security 
Act, added by section 4705(a) of the Balanced Budget Act of 1997. It 
requires State agencies that contract with managed care organizations 
to implement quality improvement strategies that address access and 
other aspects of care and services directly related to the quality of 
care provided by these managed care organizations and performance 
through annual external, independent reviews conducted by accrediting 
organizations that are approved by CMS.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/01/99                    64 FR 67223


Next Action Undetermined

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected: Businesses

Government Levels Affected: State

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

Agency Contact: Sharon Gilles, Center for Medicaid and State 
Operations,

[[Page 61617]]

Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-1177

RIN: 0938-AJ06
_______________________________________________________________________




1182. REPORTING OUTCOME AND ASSESSMENT INFORMATION SET (OASIS) DATA AS 
PART OF THE CONDITIONS OF PARTICIPATION FOR HOME HEALTH AGENCIES (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: None

Abstract: This rule requires electronic reporting of data from the 
Outcome and Assessment Information Set (OASIS) as a condition of 
participation for Home Health Agencies (HHAs). Specifically, this rule 
provides guidelines for HHAs for the electronic transmission of the 
OASIS data set as well as responsibilities of the State agency or 
contractor in collecting and transmitting this information to CMS. This 
rule also sets forth provisions concerning the privacy of patient 
identifiable information generated by the OASIS.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              01/25/99                     64 FR 3748


Next Action Undetermined

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected: Businesses

Government Levels Affected: State, Local, Tribal

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

Agency Contact: Janice Stevenson, Office of Clinical Standards and 
Quality, Department of Health and Human Services, Centers for Medicare 
& Medicaid Services, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-4882

RIN: 0938-AJ10
_______________________________________________________________________




1183. HOSPITAL CONDITIONS OF PARTICIPATION: LABORATORY SERVICES (CMS-
3014-F)

Priority: Substantive, Nonsignificant

Legal Authority: 42 USC 1302; 42 USC 1395hh

CFR Citation: 42 CFR 482.27

Legal Deadline: None

Abstract: This rule would require hospitals that transfuse blood and 
blood products to: 1) prepare and follow written procedures for 
appropriate action when it is determined that blood and blood products 
are at increased risk for transmitting hepatitis C virus (HCV); 2) 
quarantine prior collections from a donor who is at increased risk for 
transmitting HCV infection; 3) notify transfusion recipients, as 
appropriate, of the need for HCV testing and counseling; and 4) 
maintain records for at least 10 years.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            11/16/00                    65 FR 69416


Next Action Undetermined

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: None

Federalism:  Undetermined

Agency Contact: Mary Collins, OCSQ, Department of Health and Human 
Services, Centers for Medicare & Medicaid Services, 7500 Security 
Boulevard, Baltimore, MD 21244
Phone: 410 786-3189

RIN: 0938-AJ29
_______________________________________________________________________




1184. MEDICARE HOSPICE CARE AMENDMENTS (CMS-1022-P)

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

Unfunded Mandates: Undetermined

Legal Authority: PL 105-33, sec 4441(a); PL 105-33, sec 4442 to 4446; 
PL 105-33, sec 4448

CFR Citation: 42 CFR 418

Legal Deadline: None

Abstract: This rule would implement sections 4441(a), 4442 to 4446, and 
4448 of the Balanced Budget Act of 1997. Specific changes include 
updating hospice payment rates, specifying payment according to the 
site of service, modifying the hospice benefit periods, clarifying the 
services covered under the benefit, allowing hospices to contract for 
physician services, allowing waivers of certain staffing requirements 
for hospice care provided in non-urbanized areas, and extending the 
period for physician certification of an individual's terminal illness. 
Additionally, the rule would clarify other current policies.

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: No

Government Levels Affected: Undetermined

Federalism:  Undetermined

Procurement: This is a procurement-related action for which there is a 
statutory requirement. There is no paperwork burden associated with 
this action.

Agency Contact: Carol Blackford, Center for Health Plans and Providers, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-5909
Email: [email protected]

RIN: 0938-AJ36
_______________________________________________________________________




1185. EMERGENCY MEDICAL TREATMENT AND LABOR ACT (EMTALA) (CMS-1063-P)

Priority: Other Significant

Unfunded Mandates: Undetermined

Legal Authority: 42 USC 1395cc; 42 USC 1395dd

CFR Citation: 42 CFR 489.24

Legal Deadline: None

Abstract: This rule would clarify the extent of the applicability of 
the Emergency Medical Treatment and Labor Act (EMTALA).

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                             To Be                       Determined

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Federalism:  Undetermined

Agency Contact: George Morey, Center For Medicare Management, 
Department

[[Page 61618]]

of Health and Human Services, Centers for Medicare & Medicaid Services, 
7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-4653

RIN: 0938-AJ39
_______________________________________________________________________




1186. PROTECTION FOR WOMEN WHO ELECT RECONSTRUCTION AFTER A MASTECTOMY 
(CMS-2040-IFC)

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

Unfunded Mandates: Undetermined

Legal Authority: 42 USC 300gg-6; 42 USC 300gg-52

CFR Citation: 45 CFR 146; 45 CFR 148

Legal Deadline: None

Abstract: The final rule would implement the requirements of the 
Women's Health and Cancer Rights Act of 1998 (WHCRA) (Pub. L. 105-277). 
The rule will provide protection to patients who are receiving benefits 
in connection with a mastectomy and who elect breast reconstruction. 
WHCRA provides coverage for all stages of reconstruction of the breast 
on which the mastectomy has been performed; surgery and reconstruction 
of the other breast to produce a symmetrical appearance; and coverage 
for prostheses and treatment of physical complications of a mastectomy, 
including lymphedema. Group health plans and health insurance issuers 
that offer medical and surgical benefits for mastectomies are subject 
to WHCRA's coverage requirements.

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected: No

Government Levels Affected: Undetermined

Federalism:  Undetermined

Agency Contact: Kathryn McCann, Health Insurance Specialist, Department 
of Health and Human Services, Centers for Medicare & Medicaid Services, 
7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-7623

RIN: 0938-AJ44
_______________________________________________________________________




1187. SURETY BONDS REQUIREMENTS FOR SUPPLIERS OF DURABLE MEDICAL 
EQUIPMENT (CMS-6006-P)

Priority: Economically Significant. Major under 5 USC 801.

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

Legal Authority: PL 105-33, sec 4312(a); 42 USC 1395m(a)(16)

CFR Citation: 42 CFR 424.57

Legal Deadline: NPRM, Statutory, January 1, 1998.

Abstract: This proposed rule would implement the provision of the 
Balanced Budget Act of 1997 that requires a Medicare supplier of 
durable medical equipment (DME) to furnish CMS with a surety bond.

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: State

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

Agency Contact: Ralph Goldberg, Division of Provider and Supplier 
Enrollment, Department of Health and Human Services, Centers for 
Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, MD 
21244
Phone: 410 786-4870
Email: [email protected]

RIN: 0938-AJ64
_______________________________________________________________________




1188. SURETY BOND REQUIREMENTS FOR HOME HEALTH AGENCIES (HHAS) (CMS-
6001-P)

Priority: Economically Significant. Major under 5 USC 801.

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

Legal Authority: PL 105-33, sec 4312(b); PL 105-33, sec 4724(b); PL 
105-33, sec 1861(o)(7); PL 105-33, sec 1861(v)(1); PL 105-33, sec 
1891(b); PL 105-33, sec 1903(i)(18); PL 105-33, sec 1128F

CFR Citation: 42 CFR 413; 42 CFR 440; 42 CFR 441; 42 CFR 489

Legal Deadline: NPRM, Statutory, June 15, 2000.

Abstract: This rule would amend our regulations to require an HHA 
surety bond of $50,000. We would remove the 15 percent provision based 
on concerns expressed by Congress, the home health industry, surety 
association representatives, and comments published in a report by the 
General Accounting Office. This rule would require that HHAs obtain a 
surety bond by October 1, 2000. Although the bond must be effective 
January 1, 1998, we are proposing not to hold sureties liable for 
excessive interim payments attributable to the implementation of the 
interim payment systems made between October 1, 1997 and September 30, 
2000.

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Organizations

Government Levels Affected: State

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

Agency Contact: Ralph Goldberg, Division of Provider and Supplier 
Enrollment, Department of Health and Human Services, Centers for 
Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, MD 
21244
Phone: 410 786-4870
Email: [email protected]

Mary Linda Morgan, Center for Medicaid and State Operations, Department 
of Health and Human Services, Centers for Medicare & Medicaid Services, 
S2-26-12, 7500 Security Boulevard, Baltimore, MD 21244-1850
Phone: 410 786-2011
Email: [email protected]

RIN: 0938-AJ81
_______________________________________________________________________




1189. USE OF RESTRAINT AND SECLUSION IN RESIDENTIAL TREATMENT FACILITIES 
PROVIDING INPATIENT PSYCHIATRIC SERVICES TO INDIVIDUALS UNDER AGE 21 
(CMS-2065-F)

Priority: Economically Significant

Legal Authority: 42 USC 1302; 42 USC 1396d

CFR Citation: 42 CFR 441; 42 CFR 483

Legal Deadline: None

Abstract: This rule establishes a new condition of participation that

[[Page 61619]]

psychiatric residential treatment facilities that are not hospitals 
must meet to provide, or to continue to provide, the Medicaid inpatient 
psychiatric services benefit to individuals under age 21. Specifically, 
this rule establishes standards for the use of restraint or seclusion 
that residential treatment facilities must have in place to protect the 
health and safety of residents. This new COP acknowledges a resident's 
right to be free from restraint or seclusion except in emergency safety 
situations. We also are requiring residential facilities to notify a 
resident and his or her parent or legal guardian of the facility's 
policy regarding the use of restraint or seclusion during an emergency 
safety situation that occurs while the resident is in the program. We 
believe these added requirements will provide minimum safeguards to 
protect residents against the inappropriate use of restraint or 
seclusion.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              01/22/01                     66 FR 7148
Interim Final Rule Comment 
Period End                      03/23/01
Interim Final Rule Effective    03/23/01
60-Day Delay of Effective Date 
To 05/22/2001                   03/21/01                    66 FR 15800
Interim Final Rule Amendment 
with Clarification              05/22/01                    66 FR 28110
Interim Final Rule Comment 
Period End                      07/23/01


Next Action Undetermined

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Mary Kay Mullen, Health Insurance Specialist, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, S2-14-26, 7500 Security Boulevard, Baltimore, MD 
21244-1850
Phone: 410 786-5480

RIN: 0938-AJ96
_______________________________________________________________________




1190. APPLICATION OF INHERENT REASONABLENESS TO ALL MEDICARE PART B 
SERVICES (OTHER THAN PHYSICIAN SERVICES) (CMS-1908-F)

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

Legal Authority: PL 105-33, sec 4316

CFR Citation: 42 CFR 405

Legal Deadline: None

Abstract: This rule implements sections 1842(b)(8) and (9) of the 
Social Security Act, as revised by section 4316 of the Balanced Budget 
Act of 1997. It 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. This rule describes the factors CMS (or its 
carriers) will consider and the procedures that will be followed in 
establishing realistic and equitable payment amounts.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              01/07/98                      63 FR 687


Next Action Undetermined

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Federalism:  Undetermined

Agency Contact: William J. Long, Department of Health and Human 
Services, Centers for Medicare & Medicaid Services, C4-12-18, Center 
for Health Plans and Providers, 7500 Security Boulevard, Baltimore, MD 
21228
Phone: 410 786-5655
Email: [email protected]

RIN: 0938-AJ97
_______________________________________________________________________




1191. SUPPLIER STANDARDS FOR HOME OXYGEN, THERAPEUTIC SHOES, HOME 
NUTRITION THERAPY, AND CONSIGNMENT CLOSETS (CMS-6010-P)

Priority: Substantive, Nonsignificant

Legal Authority: Not Yet Determined

CFR Citation: 42 CFR 424.57

Legal Deadline: None

Abstract: This rule would establish service standards for suppliers of 
home oxygen equipment, therapeutic shoes, home infusion therapy, and 
standards for consignment closets.

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Frank Whelan, Health Insurance Sepicalist, Department 
of Health and Human Services, Centers for Medicare & Medicaid Services, 
C3-02-16, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-1302

RIN: 0938-AJ98
_______________________________________________________________________




1192. NON-FEDERAL GOVERNMENTAL PLANS EXEMPT FROM HEALTH INSURANCE 
PORTABILITY REQUIREMENTS (CMS-2033-IFC)

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

Unfunded Mandates: Undetermined

Legal Authority: Not Yet Determined

CFR Citation: 45 CFR 146

Legal Deadline: None

Abstract: This rule amends 45 CFR part 146, as promulgated at 62 FR 
16894 April 8, 1997 (BPD-890-IFC). This rule makes a correction to 45 
CFR 146.150, Guaranteed Availability of Coverage for Employers in the 
Small Group Market.

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: Undetermined

Agency Contact: Dave Holstein, Insurance Standards Team, Department of 
Health and Human Services, Centers for Medicare & Medicaid Services, 
7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-1564

RIN: 0938-AK00

[[Page 61620]]

_______________________________________________________________________




1193. PAYMENT FOR CLINICAL PSYCHOLOGY TRAINING PROGRAMS (CMS-1089-F)

Priority: Other Significant

Legal Authority: Social Security Act, sec 1861(v); Social Security Act, 
sec 1886(a)(4); PL 105-33

CFR Citation: 42 CFR 413.85

Legal Deadline: None

Abstract: This final rule revises our policy on Medicare payment for 
approved nursing and allied health education programs to permit payment 
for the costs incurred by a provider for the clinical training of 
students enrolled in a clinical psychology training program or a 
physician assistant training program. Consistent with the Conference 
Agreement language in the Conference Report accompanying the Balanced 
Budget Act of 1997 (Pub. L. 105-33), these clinical training costs 
would be paid separately on a reasonable cost basis pursuant to 
sections 1861(v) and 1886(a)(4) of the Social Security Act.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            01/12/01                     66 FR 3377


Next Action Undetermined

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Tzvi Hefter, Center for Health Plans and Providers, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, C4-07-07, 7500 Security Boulevard, Baltimore, MD 
21244-1850
Phone: 410 786-1304

RIN: 0938-AK15
_______________________________________________________________________




1194. CONDITIONS OF PARTICIPATION OF INTERMEDIATE CARE FACILITIES FOR 
PERSONS WITH MENTAL RETARDATION (CMS-3046-P)

Priority: Other Significant

Unfunded Mandates: Undetermined

Legal Authority: 42 USC 1302; 42 USC 1396d

CFR Citation: 42 CFR 400; 42 CFR 435; 42 CFR 440; 42 CFR 441; 42 CFR 
483

Legal Deadline: None

Abstract: This rule would revise the Conditions of Participation for 
Intermediate Care Facilities for Persons with Mental Retardation (ICFs/
MR). It would set forth new requirements that an ICF/MR must meet to 
participate in the Medicaid program, as well as adhere to current 
trends in the field of developmental disabilities. It would also 
increase our focus on client-directed choices, while maintaining 
essential client protections that reinforce our mandate to protect the 
health, safety, and welfare of the clients we serve.

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Federalism:  Undetermined

Agency Contact: Nancy Archer, Office of Clinical Standards and Quality, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, S3-05-27, 7500 Security Boulevard, Baltimore, MD 
21244-1850
Phone: 401 786-0596

RIN: 0938-AK23
_______________________________________________________________________




1195. CLINICAL LAB REQUIREMENTS-REVISIONS TO REGULATIONS IMPLEMENTING 
CLIA (CMS-2226-F)

Priority: Other Significant

Legal Authority: PL 100-578

CFR Citation: 42 CFR 493

Legal Deadline: None

Abstract: This rule finalizes certain laboratory requirements under the 
Clinical Laboratory Improvement Amendments of 1988 (CLIA), Public Law 
100-578. In addition, this rule concludes the prospective dates for 
certain quality control and personnel requirements, addresses comments 
received on previously promulgated CLIA regulations, and establishes 
requirements for patient test management, quality control and quality 
assurance.

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses, Organizations

Government Levels Affected: None

Agency Contact: Cecelia Hinkel, Health Insurance Specialist, Department 
of Health and Human Services, Centers for Medicare & Medicaid Services
Phone: 410 786-3347

RIN: 0938-AK24
_______________________________________________________________________




1196. MEDICARE PROVIDER AND SUPPLIER HEARING PROCEDURES (CMS-2093-P)

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

Unfunded Mandates: Undetermined

Legal Authority: 42 USC 1302; 42 USC 1395hh

CFR Citation: 42 CFR 498.40; 42 CFR 498.70; 42 CFR 498.83; 42 CFR 
498.88

Legal Deadline: None

Abstract: This rule would revise current hearing regulations applicable 
to enforcement actions taken by CMS against Medicare providers and 
suppliers (and, in some cases, certain Medicaid providers) based on a 
lack of compliance with Federal certification requirements. 
Specifically, this rule would revise existing requirements governing 
the level of specificity that petitioners must include when seeking 
review of agency actions governed by these hearing regulations. 
Additionally, this rule would clarify the meaning of ``good cause'' as 
that term is used in the hearing regulations to judge whether 
petitioners may file requests for review after filing deadlines have 
passed. The rule would also require dismissal of petitions for review 
when a petitioner has failed to file a sufficiently detailed hearing 
request within the time allotted by the regulations.

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Organizations

Government Levels Affected: None

Agency Contact: Sandy Haydock, Health Insurance Specialist, Department 
of Health and Human Services, Centers for Medicare & Medicaid Services, 
7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-3822

RIN: 0938-AK39

[[Page 61621]]

_______________________________________________________________________




1197. SUPPLEMENTARY MEDICAL INSURANCE PREMIUM SURCHARGE AGREEMENTS (CMS-
4007-P)

Priority: Other Significant

Legal Authority: Social Security Act, sec 1839(e)

CFR Citation: 42 CFR 408.200; 42 CFR 408.201; 42 CFR 408.202; 42 CFR 
408.205; 42 CFR 408.207; 42 CFR 408.210; ...

Legal Deadline: None

Abstract: This rule would implement section 1839(e) of the Social 
Security Act (SSA), as amended by section 144 of the SSA Amendments of 
1994 and the Balanced Budget Act of 1997 to allow State and local 
government agencies to pay a lump sum for the Supplementary Medical 
Insurance (SMI) late enrollment fee due for a designated group of 
eligible individuals.

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: State, Local

Agency Contact: Marty Abeln, Department of Health and Human Services, 
Centers for Medicare & Medicaid Services, Centers for Medicare 
Management, 7500 Security Boulevard, Baltimore, MD 21244-1850
Phone: 410 786-1032

Sandy Clarke, Department of Health and Human Services, Centers for 
Medicare & Medicaid Services, Center for Beneficiary Choices, 7500 
Security Boulevard, Baltimore, MD 21244
Phone: 410 786-7451

RIN: 0938-AK42
_______________________________________________________________________




1198. IMPROVEMENTS TO THE MEDICARE+CHOICE APPEALS AND GRIEVANCE 
PROCEDURES (CMS-4024-F)

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

Unfunded Mandates: Undetermined

Legal Authority: BBA, sec 4001; PL 105-33; Social Security Act, sec 
1851 to 1859

CFR Citation: 42 CFR 422; 42 CFR 489

Legal Deadline: NPRM, Judicial, January 19, 2001.

Abstract: This rule sets forth several improvements to the 
Medicare+Choice (M+C) appeal and grievance procedures. Most notably, 
this rule will--ensure that M+C enrollees receive written notice, 
including information about appeal rights, at least four days before 
the proposed termination date of provider services; and establishe a 
new fast-track independent review process for appealing decisions to 
terminate services.
This rule also clarifies hospitals responsibility for issuing discharge 
notices, amends the Medicare provider agreement regulations with regard 
to beneficiary notification requirements, and sets forth beneficiary 
grievance procedures.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            01/24/01                     66 FR 7593
Final Action                     To Be                       Determined

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Organizations

Government Levels Affected: None

Additional Information: The Settlement Agreement in Grijalva v. Shalala 
contemplates that a final rule will be published by the end of 2002.

Agency Contact: Tony Culotta, Department of Health and Human Services, 
Centers for Medicare & Medicaid Services, 7500 Security Boulevard, 
Baltimore, MD 21244
Phone: 410 786-4661

RIN: 0938-AK48
_______________________________________________________________________




1199. RECOGNITION OF THE AMERICAN OSTEOPATHIC ASSOCIATION FOR AMBULATORY 
SURGICAL CENTER PROGRAMS (CMS-2079-FN)

Priority: Routine and Frequent

Legal Authority: Social Security Act, sec 1865(b)(l); Social Security 
Act, sec 1832(a)(F)(i)

CFR Citation: Not Yet Determined

Legal Deadline: NPRM, Statutory, January 12, 2001, Must be published 60 
days after receipt of the November 14, 2000 application.

Abstract: In this notice we announce the receipt of an application from 
the American Osteopathic Association (AOA), for recognition as a 
national accreditation program for ambulatory surgical centers that 
wish to participate in the Medicare or Medicaid programs. The Social 
Security Act requires that the Secretary publish a notice identifying 
the national accreditation body making the request, describing the 
nature of the request, and providing a 30-day public comment period.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Proposed Notice                 03/14/01                    66 FR 14906


Next Action Undetermined

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: Undetermined

Agency Contact: Joan Benny, Health Insurance Specialist, Department of 
Health and Human Services, Centers for Medicare & Medicaid Services, 
7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-7233

RIN: 0938-AK53
_______________________________________________________________________




1200. CHALLENGES TO NATIONAL COVERAGE DETERMINATIONS AND LOCAL COVERAGE 
DETERMINATIONS (CMS-3063-P)

Priority: Other Significant

Legal Authority: Sec 522 of the BIPA 2000

CFR Citation: 42 CFR 405

Legal Deadline: NPRM, Statutory, October 1, 2001.
The effective date for regulation changes is 10/01/01.

Abstract: This rule proposes changes to the appeals process for 
national and local coverage determinations.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                             To Be                       Determined

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: Undetermined

Federalism:  Undetermined

Agency Contact: James Bossenmeyer, Health Insurance Specialist, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, C5-16-26, 7500 Security Boulevard, Baltimore, MD 
21244

[[Page 61622]]

Phone: 410 786-9317
Email: [email protected]

RIN: 0938-AK60
_______________________________________________________________________




1201. REVISED PROCESS FOR MAKING MEDICARE COVERAGE DECISIONS (CMS-3062-
N)

Priority: Other Significant

Legal Authority: Sec 522 of the BIPA

CFR Citation: None

Legal Deadline: Other, Statutory, October 1, 2001, Revision notice.

Abstract: This notice will announce a revised process for making 
Medicare national coverage determinations. It implements section 522 of 
the Benefits Improvement and Protection Act of 2000.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                             To Be                       Determined

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses, Governmental Jurisdictions, 
Organizations

Government Levels Affected: Federal

Agency Contact: Vadim Lubarsky, Health Insurance Specialist, Department 
of Health and Human Services, Centers for Medicare & Medicaid Services, 
C5-16-03, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-0840

RIN: 0938-AK61
_______________________________________________________________________




1202. HEALTH INSURANCE REFORM: STANDARDS FOR ELECTRONIC SIGNATURES (CMS-
0051-F)

Priority: Other Significant. Major under 5 USC 801.

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

Legal Authority: PL 104-91; Social Security Act, sec 1171 to 1179

CFR Citation: Not Yet Determined

Legal Deadline: None

Abstract: This final rule is being jointly developed by CMS and the 
Department of Commerce. The final rule implements administrative 
simplification initiatives that have a national scope beyond the 
Medicare and Medicaid programs. This rule establishes standards for 
electronic signature for health care claims processing.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            08/12/98                    63 FR 43242
NPRM Comment Period End         10/13/98
Final Action                     To Be                       Determined

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected: No

Government Levels Affected: State, Local, Federal

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

Additional Information: Previously reported under 0938-AI57.

Agency Contact: Barbara Clark, Office of Information Services, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, N2-14-10, 7500 Security Boulevard, Baltimore, MD 
21244-1850
Phone: 410 786-3017

Stanley B. Nachimson, Senior Technical Advisor, Department of Health 
and Human Services, Centers for Medicare & Medicaid Services, N2-16-03, 
7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-6153

RIN: 0938-AK63
_______________________________________________________________________




1203. PHYSICIANS' REFERRALS TO HEALTH CARE ENTITIES WITH WHICH THEY HAVE 
FINANCIAL RELATIONSHIPS-PHASE II (CMS-1810-FC)

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

Unfunded Mandates: Undetermined

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

CFR Citation: 42 CFR 411

Legal Deadline: None

Abstract: On January 4, 2001, we issued a final rule with comment 
period (phase I) to incorporate into regulations paragraphs (a), (b), 
and (h) of section 1877 of the Social Security Act. This final rule 
with comment period (phase II) will address comments from the January 
9, 1998 proposed rule concerning the remainder of section 1877, 
including the ownership and investment exceptions and the compensation 
exceptions. In addition, this final rule will address comments from the 
January 4, 2001 final rule with comment period.

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected: No

Government Levels Affected: State, Local

Federalism:  Undetermined

Agency Contact: Joanne Sinsheimer, Technical Assistant, CHPP, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-4620

RIN: 0938-AK67
_______________________________________________________________________




1204. RATE OF REIMBURSEMENT OF PHOTOCOPY EXPENSES FOR PROSPECTIVE 
PAYMENT SYSTEM PROVIDERS (CMS-3055-P)

Priority: Economically Significant

Legal Authority: Social Security Act, sec 1102; Social Security Act, 
sec 1154; Social Security Act, sec 1159; Social Security Act, sec 1866; 
Social Security Act, sec 1871

CFR Citation: 42 CFR 476.78

Legal Deadline: None

Abstract: This rule would adjust the rate of reimbursement for 
photocopy expenses of Medicare Prospective Payment System (PPS) 
providers of medical records requested by Utilization and Quality 
Control Peer Review Organizations.
This rule is necessary due to changes in the inflation factor, 
salaries, and the cost of living. We would specify a provision for 
periodic review and adjustment of the per-page reimbursement cost to 
account for inflation and changes in technology. The methodology for 
calculating the per-page reimbursement rate would remain unchanged.
We also propose to expand the scope of the regulation to encompass 
other providers subject to the Medicare PPS (for example, skilled 
nursing facilities and home health agencies), as well as hospitals.

[[Page 61623]]

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: Undetermined

Agency Contact: Valerie Mattison-Brown, Department of Health and Human 
Services, Centers for Medicare & Medicaid Services, Office of Clinical 
Standards, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-5958

RIN: 0938-AK68
_______________________________________________________________________




1205. MEDICARE INPATIENT DISPROPORTIONATE SHARE HOSPITAL ADJUSTMENT 
CALCULATION (CMS-1171-IFC)

Priority: Other Significant

Legal Authority: Not Yet Determined

CFR Citation: 42 CFR 412106

Legal Deadline: None

Abstract: This rule clarifies the Medicare DSH adjustment calculation 
in reference to the inclusion of Medicaid patient days. It also 
describes the criteria used in calculating the Medicare DSH adjustment 
for hospitals for purposes of payment under the prospective payment 
system.

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Stephen Phillips, Center for Health Plans and 
Providers, Department of Health and Human Services, Centers for 
Medicare & Medicaid Services, C4-05-27, 7500 Security Boulevard, 
Baltimore, MD 21244
Phone: 410 786-4548

RIN: 0938-AK77
_______________________________________________________________________




1206. STATEMENT OF INTENT (CMS-1185-P)

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

Legal Authority: Not Yet Determined

CFR Citation: 42 CFR 424

Legal Deadline: NPRM, Statutory, November 1, 2001.

Abstract: The purpose of this regulation is to eliminate the written 
statement of intent procedures for filing Medicare claims, from the 
current Medicare regulation at 42 CFR 424.45. Providers, suppliers and 
other qualified claimants would still have 15 to 27 months to submit 
valid claims to Medicare.

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected: No

Government Levels Affected: State, Federal

Federalism:  Undetermined

Agency Contact: David Walczak, Center for Health Plans and Providers, 
Plan and Provider Purchasing Policy Group, Department of Health and 
Human Services, Centers for Medicare & Medicaid Services, C4-07-07, 
7500 Security Boulevard, Baltimore, MD 21244-1850
Phone: 410 786-4475

RIN: 0938-AK79
_______________________________________________________________________




1207. HOSPITAL REFERENCE LABORATORY AND MEDICARE SECONDARY PAYER (CMS-
1187-P)

Priority: Info./Admin./Other

Legal Authority: Not Yet Determined

CFR Citation: Not Yet Determined

Legal Deadline: None

Abstract: This regulation will address current procedures with respect 
to independent laboratories' administrative requirements in gathering 
and verifying Medicare Secondary Payer information in reference lab 
situations involving ``nonpatient'' claims.

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Federalism:  Undetermined

Agency Contact: Paul Olenick, Director, Division of Beneficiary and 
Insurance Issues, Department of Health and Human Services, Centers for 
Medicare & Medicaid Services, C4-07-07, 7500 Security Boulevard, 
Baltimore, MD 21244-1850
Phone: 410 786-4472

RIN: 0938-AK87
_______________________________________________________________________




1208. PORTABILITY IN THE GROUP HEALTH INSURANCE MARKET--SHARED HHS 
PROVISIONS (CMS-2048-F)

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

Unfunded Mandates: Undetermined

Legal Authority: 42 USC 300gg

CFR Citation: 42 CFR 144.103; 42 CFR 146.101; 42 CFR 146.111; 42 CFR 
146.113; 42 CFR 146.115; 42 CFR 146.117; 42 CFR 146.119; ...

Legal Deadline: None

Abstract: This regulation will specify the limitations on only 
preexisting conditions exclusion periods imposed by group health 
insurance issues and non-Federal government plans, and the requirements 
on such issues and plans to offer special enrollment to certain 
individuals who lose eligibility for other coverage when a new 
dependent becomes eligible through marriage, birth or adoption.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              04/08/97                    62 FR 16893
Interim Final Rule Comment 
Period End                      07/07/97
Interim Final Rule Effective    07/07/97


Next Action Undetermined

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses, Governmental Jurisdictions

Government Levels Affected: State, Local

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

Agency Contact: Kathryn McCann, Health Insurance Specialist, Department 
of Health and Human Services, Centers for Medicare & Medicaid Services, 
7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-7623

RIN: 0938-AK88

[[Page 61624]]

_______________________________________________________________________




1209.  EXTENDED MEDICAID FOR CERTAIN FAMILIES WHO LOSE MEDICAID 
ELIGIBILITY BECAUSE OF EARNED INCOME AND THE RESIDENCY OF MINOR PARENTS 
AND PREGNANCY (CMS 2026-F)

Priority: Economically Significant. Major under 5 USC 801.

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

Legal Authority: Sec. 1102 of the SSA; Sec. 303 of the FSA; Sec. 103 of 
PRWORA

CFR Citation: 42 CFR 435; 42 CFR 436; 42 CFR 440; 42 CFR 447

Legal Deadline: None

Abstract: This final rule amends the Medicaid regulations that specify 
eligibility groups and conditions of eligibility. It revises the 
provisions for extended Medicaid to families who lose Medicaid under 
section 1931 of the Social Security Act because of income from, or 
hours of, employment, or when the earned income disregards are lost.
This change codifies and interprets certain provisions of the Family 
Support Act of 1988, as amended by the Omnibus Budget Reconciliation 
Act of 1989 and 1990, and the Personal Responsibility and Work 
Opportunity Act of 1996.

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: No

Government Levels Affected: State, Federal

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

Agency Contact: Cheryl Camillo, Health Insurance Specialist, Department 
of Health and Human Services, Centers for Medicare & Medicaid Services, 
S2-01-16, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-1068

RIN: 0938-AK92
_______________________________________________________________________




1210.  EXTENDING MEDICARE ENTITLEMENT WHEN DISABILITY BENEFIT 
ENTITLEMENT ENDS BECAUSE OF SUBSTANTIAL GAINFUL ACTIVITY (CMS-4018-P)

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

Unfunded Mandates: Undetermined

Legal Authority: Sec. 202 of the TWWIIA of 1999; PL 106-170 of the 
TWWIA of 1999

CFR Citation: 42 CFR 406.12

Legal Deadline: None

Abstract: This rule would implement the Ticket to Work and Work 
Incentives Act of 1999. It would provide for continued Medicare 
entitlement for an additional 4.5 years beyond the current limit.

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected: No

Government Levels Affected: Undetermined

Federalism:  Undetermined

Agency Contact: Denise Cox, Department of Health and Human Services, 
Centers for Medicare & Medicaid Services, 7500 Security Boulevard, 
Baltimore, MD 21244
Phone: 410 786-3195

RIN: 0938-AK94
_______________________________________________________________________




1211.  RELIEF FROM MEDICARE PART A LATE ENROLLMENT PENALTY FOR 
GROUP BUY-IN FOR STATE AND LOCAL RETIREES (CMS-4022-P)

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

Unfunded Mandates: Undetermined

Legal Authority: BIPA Section 331

CFR Citation: 42 CFR 408

Legal Deadline: Final, Statutory, January 1, 2002.

Abstract: This rule would implement section 331 of BIPA. It would 
provide for a reduction in the Medicare part A late enrollment penalty 
for any beneficiary who is subject to a premium surcharge and is in a 
qualified State or local government retiree group.

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected: No

Government Levels Affected: Undetermined

Federalism:  Undetermined

Agency Contact: Delilah Murphy, Health Insurance Specialist, Department 
of Health and Human Services, Centers for Medicare & Medicaid Services, 
7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-4300

RIN: 0938-AK99
_______________________________________________________________________




1212.  MODIFICATIONS TO THE STATE CHILDREN'S HEALTH INSURANCE 
PROGRAM (CMS-2006-IFC)

Priority: Substantive, Nonsignificant

Legal Authority: PL 105-33

CFR Citation: 42 CFR 435; 42 CFR 436; 42 CFR 457

Legal Deadline: None

Abstract: This interim final rule with a comment period delays the 
effective date, revises certain provisions, and makes technical 
corrections and clarifications to the January 11, 2001 final rule which 
implemented the State Children's Health Insurance Program.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              06/25/01                    66 FR 33810
Interim Final Rule Comment 
Period End                      07/25/01
Interim Final Rule Effective    08/24/01


Next Action Undetermined

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: State

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

Agency Contact: Regina Fletcher, Health Insurance Specialist, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, S2-01-16, 7500 Security Boulevard, Baltimore, MD 
21244
Phone: 410 786-3293

RIN: 0938-AL00

[[Page 61625]]

_______________________________________________________________________




1213.  CONTINUE TO ALLOW STATES AN OPTION UNDER THE MEDICAID 
SPOUSAL IMPOVERISHMENT PROVISIONS TO INCREASE THE COMMUNITY SPOUSE'S 
INCOME WHEN ADJUSTING THE PROTECTED RESOURCE ALLOWANCE (CMS-2128-P)

Priority: Substantive, Nonsignificant

Unfunded Mandates: Undetermined

Legal Authority: Sec 1924 of the Social Security Act

CFR Citation: 42 CFR 431

Legal Deadline: None

Abstract: This rule will revise our existing Medicaid regulations to 
include part of the spousal impoverishment provisions of the Social 
Security Act. This rule would allow States an option to count the 
institutionalized spouse's income as the community spouse's income when 
adjusting the protected resource allowance. Specifically, it would give 
States an option either to use an income-first or resource-first method 
when determining that the community spouse has insufficient income to 
meet minimum monthly maintenance needs.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/07/01                    66 FR 46763


Next Action Undetermined

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Roy Trudel, Department of Health and Human Services, 
Centers for Medicare & Medicaid Services, C4-20-15, Center for Medicaid 
and State Operations, 7500 Security Boulevard, Baltimore, MD 21244-1850
Phone: 410 786-3417

RIN: 0938-AL06
_______________________________________________________________________




1214.  MEDICARE LIMITS ON THE VALUATION OF A DEPRECIABLE ASSET 
RECOGNIZED AS AN ALLOWANCE FOR DEPRECIATION AND INTEREST ON CAPITAL 
INDEBTEDNESS AFTER A CHANGE OF OWNERSHIP (CMS-1004-F)

Priority: Other Significant

Unfunded Mandates: Undetermined

Legal Authority: Sec. 1861(v) of the Social Security Act as Amended

CFR Citation: 42 CFR 413.134

Legal Deadline: None

Abstract: This rule responds to public comments on, and makes technical 
corrections to, the final rule with comment period that revised the 
Medicare provider reimbursement regulations setting forth requirements 
related to allowable costs. That final rule with comment period set a 
limit on the valuation of a depreciable asset that may be recognized in 
establishing an appropriate allowance for depreciation and for interest 
on capital indebtedness after a change of ownership that occurs on or 
after December 1, 1997. The provisions apply to providers that are 
reimbursed on the basis of reasonable costs and implement revisions 
included in the Balanced Budget Act of 1997.

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Ann Pash, Center for Medicare Management,, Department 
of Health and Human Services, Centers for Medicare & Medicaid Services, 
7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-4516
Email: [email protected]

RIN: 0938-AL12
_______________________________________________________________________




1215.  UPDATE INTEREST ASSESSMENT ON MEDICARE OVERPAYMENT AND 
UNDERPAYMENT (CMS-6014-P)

Priority: Other Significant

Legal Authority: Sec. 1815(d) ofthe Social Security Act; Sec. 1833(j) 
ofthe Social Security Act

CFR Citation: 42 CFR 405.378

Legal Deadline: None

Abstract: This rule changes the formula used to compute interest on 
provider, supplier overpayments and underpayments.

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected: Businesses, Organizations

Government Levels Affected: None

Agency Contact: Paul Thomas Reed, Financial Management Specialists, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, C3-15-07, 7500 Security Boulevard, Blatimore, MD 
21244
Phone: 410 786-4001
Email: [email protected]

RIN: 0938-AL14
_______________________________________________________________________




1216.  USE OF RESTRAINT 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.

Unfunded Mandates: Undetermined

Legal Authority: Childrens's Health Act of 2000

CFR Citation: Not Yet Determined

Legal Deadline: None

Abstract: This rule would establish common terminology and basic 
expectations for the use of restraint and seclusion for health care 
facilities that furnish inpatient or residential care and receive 
Medicare and Medicaid funding.

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected: Businesses

Government Levels Affected: Undetermined

Federalism:  Undetermined

Agency Contact: Frank Sokolik, Center for Medicaid and State 
Operations, Department of Health and Human Services, Centers for 
Medicare & Medicaid Services, S2-13-23, 7500 Security Boulevard, 
Baltimore, MD 21244-1850
Phone: 410 786-7089

RIN: 0938-AL26
_______________________________________________________________________




1217.  PAYMENT FOR RESPIRATORY ASSIST DEVICES WITH BI-LEVEL 
CAPABILITY AND A BACK-UP RATE (CMS-1167-P)

Priority: Other Significant

Legal Authority: 42 CFR 1302; 42 CFR 1395hh; 42 CFR 1395rr(b)(1); PL 
103-66

[[Page 61626]]

CFR Citation: 42 CFR 414

Legal Deadline: None

Abstract: This proposed rule would clarify that respiratory assist 
devices with bi-level capability and a back-up rate must be paid as 
capped rental items and not paid as items requiring frequent and 
substantial servicing, as defined in section 1834(a)(3) of the Social 
Security Act.

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: None

Federalism:  Undetermined

Agency Contact: Joel Kaiser, Center for Health Plan and Providers, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-4499

RIN: 0938-AL27
_______________________________________________________________________


Department of Health and Human Services (HHS)         Completed Actions


Centers for Medicare & Medicaid Services (CMS)



_______________________________________________________________________




1218. MEDICAID DRUGS REBATE PROGRAM (CMS-2046-FC)

Priority: Other Significant

CFR Citation: 42 CFR 447; 42 CFR 441

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn                       09/12/01

Regulatory Flexibility Analysis Required: No

Government Levels Affected: State

Federalism:  Undetermined

Agency Contact: Larry Reed
Phone: 410 786-3325

Peggy Rahn
Phone: 410 786-3284

RIN: 0938-AF42
_______________________________________________________________________




1219. LIABILITY FOR THIRD PARTIES TO PAY FOR SERVICES (CMS-2080-P)

Priority: Other Significant

CFR Citation: 42 CFR 433

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn                       09/12/01

Regulatory Flexibility Analysis Required: Yes

Government Levels Affected: State, Federal

Agency Contact: Robert Nakielny
Phone: 410 786-4466

RIN: 0938-AH01
_______________________________________________________________________




1220. REQUIREMENTS FOR ENROLLMENT OF MEDICAID RECIPIENTS UNDER COST 
EFFECTIVE EMPLOYER-BASED GROUP HEALTH PLANS (CMS-2047-FC)

Priority: Substantive, Nonsignificant

CFR Citation: 42 CFR 435; 42 CFR 436

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn                       09/12/01

Regulatory Flexibility Analysis Required: No

Government Levels Affected: State

Agency Contact: Gwendolyn Talvert
Phone: 410 786-5928
Email: [email protected]

RIN: 0938-AH48
_______________________________________________________________________




1221. REVISIONS TO CONDITIONS FOR COVERAGE FOR AMBULATORY SURGICAL 
CENTERS (CMS-3887-P)

Priority: Other Significant

CFR Citation: 42 CFR 416

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn                       09/12/01

Regulatory Flexibility Analysis Required: Yes

Government Levels Affected: None

Federalism:  Undetermined

Agency Contact: Marcia Newton
Phone: 410 786-5265

Joan Brooks
Phone: 410 786-5526

RIN: 0938-AH83
_______________________________________________________________________




1222. MEDICARE PROGRAM: PROSPECTIVE PAYMENT SYSTEM FOR INPATIENT 
REHABILITATION HOSPITAL SERVICES (CMS-1069-F)

Priority: Economically Significant. Major under 5 USC 801.

CFR Citation: None

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    08/07/01                    66 FR 41316

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Laurence Wilson
Phone: 410 786-4603

RIN: 0938-AJ55
_______________________________________________________________________




1223. STATE HEALTH INSURANCE ASSISTANCE PROGRAM (SHIP) (CMS-4005-IFC)

Priority: Info./Admin./Other

CFR Citation: 42 CFR 403.502; 42 CFR 403.504; 42 CFR 403.508

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              06/01/00                    65 FR 34983

Regulatory Flexibility Analysis Required: No

Government Levels Affected: State, Local

Agency Contact: Eric Lang
Phone: 410 966-3193

RIN: 0938-AJ67
_______________________________________________________________________




1224. PRACTICE EXPENSE DATA COLLECTION (CMS-1111-IFC)

Priority: Substantive, Nonsignificant

CFR Citation: 42 CFR 414

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Rule                      11/01/00                    65 FR 65376

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Kenneth Marsalek
Phone: 301 786-1115

RIN: 0938-AK14

[[Page 61627]]

_______________________________________________________________________




1225. PROVISIONS OF THE BALANCED BUDGET AND REFINEMENT ACT OF 1999; 
HOSPITAL INPATIENT PAYMENTS AND RATES AND COSTS OF GRADUATE MEDICAL 
EDUCATION (CMS-1131-F)

Priority: Other Significant. Major under 5 USC 801.

CFR Citation: 42 CFR 410.152; 42 CFR 412.90; 42 CFR 412.102; 42 CFR 
412.103; 42 CFR 412.105; 42 CFR 412.108; 42 CFR 413.40; 42 CFR 413.70; 
42 CFR 413.86; ...

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    08/01/01                    66 FR 39828
Final Action Effective          10/01/01

Regulatory Flexibility Analysis Required: Yes

Government Levels Affected: None

Agency Contact: Stephen Phillips
Phone: 410 786-4548

RIN: 0938-AK20
_______________________________________________________________________




1226. REQUIREMENTS FOR THE RECREDENTIALING OF MEDICARE+CHOICE 
ORGANIZATION PROVIDERS (CMS-1160-F)

Priority: Substantive, Nonsignificant

CFR Citation: 42 CFR 422.204

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    09/12/01                    66 FR 47410

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Siera Gollan
Phone: 410 786-6664

RIN: 0938-AK41
_______________________________________________________________________




1227. MEDICAID MANAGEMENT INFORMATION SYSTEM REVISED DEFINITION OF 
``MECHANIZED CLAIMS PROCESSING AND INFORMATION RETRIEVAL SYSTEM'' (CMS-
2123-IFC)

Priority: Economically Significant. Major under 5 USC 801.

CFR Citation: 42 CFR 433.111; 42 CFR 433.112; 42 CFR 433.119

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn                       08/23/01

Regulatory Flexibility Analysis Required: Yes

Government Levels Affected: State, Federal

Agency Contact: Harvey Heyman
Phone: 410 786-0712

RIN: 0938-AK44
_______________________________________________________________________




1228. PROSPECTIVE PAYMENT SYSTEM AND CONSOLIDATED BILLING FOR SKILLED 
NURSING FACILITIES-UPDATE (CMS-1163-F)

Priority: Other Significant. Major under 5 USC 801.

CFR Citation: 42 CFR 411.15; 42 CFR 489.20

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

NPRM                            05/10/01                    66 FR 23984
Final Action                    07/31/01                    66 FR 39562

Regulatory Flexibility Analysis Required: Yes

Government Levels Affected: None

Agency Contact: William Ullman
Phone: 401 786-5667

RIN: 0938-AK47
_______________________________________________________________________




1229. CIVIL MONEY PENALTIES, ASSESSMENTS, AND REVISED SANCTION 
AUTHORITIES (CMS-6145-FC)

Priority: Info./Admin./Other

CFR Citation: 42 CFR 402.1; 42 CFR 402.105; 42 CFR 402.107; 42 CFR 
405.520

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    09/28/01                    66 FR 49544
Comment Period End              10/29/01

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Joel Cohen
Phone: 410 786-3349

RIN: 0938-AK49
_______________________________________________________________________




1230. UPDATE TO THE PROSPECTIVE PAYMENT SYSTEM FOR HOME HEALTH AGENCIES 
FOR FY 2002 (CMS-1147-NC)

Priority: Other Significant

CFR Citation: None

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Notice                          07/03/01                    66 FR 35253

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Susan Levy
Phone: 410 786-9364

RIN: 0938-AK51
_______________________________________________________________________




1231. PROSPECTIVE PAYMENT SYSTEM FOR HOSPITAL OUTPATIENT SERVICES FOR 
CALENDAR YEAR 2002 (CMS-1159-F)

Priority: Other Significant. Major under 5 USC 801.

CFR Citation: 42 CFR 413; 42 CFR 419; 42 CFR 489

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

NPRM                            08/24/01                    66 FR 44672
Final Rule                      11/01/01                    66 FR 55856

Regulatory Flexibility Analysis Required: Yes

Government Levels Affected: None

Agency Contact: Nancy Edwards
Phone: 410 786-0378
Email: [email protected]

George Morey
Phone: 410 786-4653

RIN: 0938-AK54
_______________________________________________________________________




1232. MEDICARE AS SECONDARY PAYER-RECOVERY OF CONDITIONAL PAYMENTS (CMS-
6009-P)

Priority: Other Significant

CFR Citation: 42 CFR 411.20; 42 CFR 411.24

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn                       04/01/01

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: None

Agency Contact: William Zavoina
Phone: 410 966-7461

RIN: 0938-AK55

[[Page 61628]]

_______________________________________________________________________




1233. FIVE YEAR REVIEW OF WORK RELATIVE VALUE UNITS UNDER THE PHYSICIAN 
FEE SCHEDULE PROPOSED NOTICE (CMS-1170-PN)

Priority: Other Significant

CFR Citation: None

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Notice                          06/08/01                    66 FR 31028

Regulatory Flexibility Analysis Required: No

Government Levels Affected: Federal

Agency Contact: Terrence Kay
Phone: 410 786-4497

James Menas
Phone: 410 786-4507

RIN: 0938-AK56
_______________________________________________________________________




1234. REVISIONS TO PAYMENT POLICIES UNDER THE PHYSICIAN FEE SCHEDULE FOR 
CALENDAR YEAR 2002 (CMS-1169-F)

Priority: Economically Significant. Major under 5 USC 801.

CFR Citation: 42 CFR 405; 42 CFR 410; 42 CFR 411; 42 CFR 414; 42 CFR 
415

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

NPRM                            08/02/01                    66 FR 40372
Final Rule                      11/01/01                    66 FR 55245

Regulatory Flexibility Analysis Required: Yes

Government Levels Affected: None

Agency Contact: Diane Milstead
Phone: 410 786-3355

Terrence Kay
Phone: 410 786-4497

RIN: 0938-AK57
_______________________________________________________________________




1235. CHANGES TO NATIONAL COVERAGE DETERMINATIONS AND LOCAL COVERAGE 
DETERMINATIONS (CMS-4019-FC)

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Duplicate of 0938-AK60          09/04/01

RIN: 0938-AK58
_______________________________________________________________________




1236. REPLACEMENT OF REASONABLE CHARGE METHODOLOGY BY FEE SCHEDULES FOR 
PARENTERAL AND ENTERAL NUTRIENTS, EQUIPMENT, AND SUPPLIES (CMS-1010-F)

Priority: Other Significant

CFR Citation: 42 CFR 414

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    08/28/01                    66 FR 45173

Regulatory Flexibility Analysis Required: Yes

Government Levels Affected: None

Agency Contact: Joel Kaiser
Phone: 410 786-4499

RIN: 0938-AK66
_______________________________________________________________________




1237. CHANGES TO THE HOSPITAL INPATIENTS PROSPECTIVE PAYMENT SYSTEM FOR 
FISCAL YEAR 2002 RATES (CMS-1158-F)

Priority: Economically Significant. Major under 5 USC 801.

CFR Citation: 42 CFR 412; 42 CFR 413; 42 CFR 485; 42 CFR 486

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

NPRM                            05/04/01                    66 FR 22646
Final Action                    08/01/01                    66 FR 39828
Final Action Effective          10/01/01

Regulatory Flexibility Analysis Required: Yes

Government Levels Affected: None

Agency Contact: Stephen Phillips
Phone: 410 786-4548

RIN: 0938-AK73
_______________________________________________________________________




1238. CHANGES TO INPATIENT BIPA FOR FISCAL YEAR 2001 (CMS-1178-F)

Priority: Economically Significant

CFR Citation: 42 CFR 410.152; 42 CFR 412.63; 42 CFR 412.92; 42 CFR 
412.105; 42 CFR 412.106; 42 CFR 412.108; 42 CFR 413.40; 42 CFR 413.70; 
42 CFR 413.80; 42 CFR 413.86; 42 CFR 413.87

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              06/13/01                    66 FR 32172
Interim Final Rule Effective    06/13/01
Interim Final Rule Comment 
Period End                      07/13/01
Final Action                    08/01/01                    66 FR 39828
Final Action Effective          10/01/01

Regulatory Flexibility Analysis Required: Yes

Government Levels Affected: None

Agency Contact: Stephen Phillips
Phone: 410 786-4548

RIN: 0938-AK74
_______________________________________________________________________




1239. MEDICARE+CHOICE ESRD RATES (CMS-1182-FN)

Priority: Other Significant

CFR Citation: None

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    10/01/01                    66 FR 49958

Regulatory Flexibility Analysis Required: No

Government Levels Affected: Federal

Agency Contact: Anne Hornsby
Phone: 410 786-1181

RIN: 0938-AK75
_______________________________________________________________________




1240. PROCEDURES FOR PUBLIC CONSULTATIONS FOR CODING AND PAYMENT 
DETERMINATIONS FOR NEW LABORATORY TESTS (CMS-1186-N)

Priority: Other Significant. Major under 5 USC 801.

CFR Citation: None

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Notice                          06/29/01                    66 FR 34693

Regulatory Flexibility Analysis Required: Yes

Government Levels Affected: Local, Federal

Agency Contact: Tzvi Hefter
Phone: 410 786-1304

RIN: 0938-AK80
_______________________________________________________________________




1241. RECOGNITION OF THE AMERICAN OSTEOPATHIC ASSOCIATION FOR CRITICAL 
ACCESS HOSPITALS (CMS-2099-N)

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

CFR Citation: 42 CFR 488.4

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Proposed Notice                 04/16/01                    66 FR 19509
Withdrawn                       09/04/01

Regulatory Flexibility Analysis Required: No

[[Page 61629]]

Government Levels Affected: State

Agency Contact: Irene Dustin
Phone: 410 786-0495
Email: [email protected]

RIN: 0938-AK84
_______________________________________________________________________




1242. PROTECTION AND PROMOTION OF RESIDENT RIGHTS (CMS-3065-P)

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

CFR Citation: Not Yet Determined

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Merged With 0938-AL26           09/13/01

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: State, Local

Federalism:  Undetermined

Agency Contact: Julie Moyers
Phone: 410 786-6772

RIN: 0938-AK85
_______________________________________________________________________




1243. STANDARDS FOR ELECTRONIC TRANSACTIONS-ELIMINATION OF NDC CODING 
STANDARDS (CMS-0006-P)

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

CFR Citation: 42 CFR 162.1002

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Merged With 0938-AK64           09/04/01

Regulatory Flexibility Analysis Required: Yes

Government Levels Affected: State, Local, Tribal, Federal

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

Agency Contact: Stanley B. Nachimson
Phone: 410 786-6153

RIN: 0938-AK86
_______________________________________________________________________




1244.  MODIFICATION OF THE MEDICAID UPPER PAYMENT LIMIT 
TRANSITION PERIOD FOR INPATIENT, OUTPATIENT HOSPITALS, NURSING AND 
INTERMEDIATE CARE FACILITY SERVICES FOR THE MENTALLY RETARDED (CMS-2100-
P)

Priority: Economically Significant

Legal Authority: BIPA sec 701

CFR Citation: 42 CFR 447.272; 42 CFR 447.321

Legal Deadline: None

Abstract: This rule will create a transition period for States that 
submitted State plan amendments to CMS before March 13, 2001 that have 
not yet been approved or disapproved.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            04/03/01                    66 FR 17657
Final Action                    09/05/01                    66 FR 46397

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: State

Agency Contact: Larry Reed, Chief, Medicaid Noninstitutional Payment 
Policy Branch, Department of Health and Human Services, Centers for 
Medicare & Medicaid Services, S2-01-16, 7500 Security Boulevard, 
Baltimore, MD 21244
Phone: 410 786-3325

RIN: 0938-AK89
_______________________________________________________________________




1245.  HOSPITAL CONDITIONS OF PARTICIPATION: ANESTHESIA 
SERVICES (CMS-3070-F)

Priority: Other Significant

Legal Authority: Sec 1102 of the Social Security Act; sec 1871 of the 
Social Security Act

CFR Citation: 42 CFR 416; 42 CFR 482; 42 CFR 485

Legal Deadline: None

Abstract: This rule will allow CRNAs to administer anesthesiology 
services without supervision of a physician, if the Governor of a State 
requests an exemption from current Federal laws requiring such 
supervision.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            07/05/01                    66 FR 35395
Final Rule                      11/13/01                    66 FR 56762

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: State, Federal

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

Agency Contact: Debbie Hattery, Health Insurance Specialist, Department 
of Health and Human Services, Centers for Medicare & Medicaid Services, 
S3-02-01, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-1855

RIN: 0938-AK95
_______________________________________________________________________




1246.  MEDICARE PROGRAM; EMERGENCY APPROVAL FOR COVERAGE OF 
END-STAGE RENAL DISEASE FACILITIES IN THE HOUSTON, TEXAS AREA (CMS-3074-
F)

Priority: Substantive, Nonsignificant

Legal Authority: 42 USC 1302; 42 USC 1230b-8; 42 USC 1395x; 42 USC 
1395y(a); 42 USC 1395hh; 42 USC 1395kk; 42 USC 1395rr

CFR Citation: 42 CFR 405.2175

Legal Deadline: None

Abstract: This final rule grants a waiver of the end-stage renal 
disease conditions for coverage to permit the transplant team of an 
approved renal transplant center to furnish covered kidney transplant 
services in three specific hospitals in the Houston, Texas area during 
a state of emergency crisis.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Action                    06/20/01                    66 FR 33030
Final Action Effective          06/15/01

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Jacqueline Sheridan, Office of Clinical Standards and 
Quality, Department of Health and Human Services, Centers for Medicare 
& Medicaid Services, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-4635

RIN: 0938-AK98

[[Page 61630]]

_______________________________________________________________________




1247.  MEDICARE AND MEDICAID PROGRAMS; CHANGE OF AGENCY NAME: 
TECHNICAL AMENDMENTS (CMS-9010-FC)

Priority: Info./Admin./Other

Legal Authority: 42 USC 1302; 42 USC 1395hh

CFR Citation: 42 CFR ch I; 42 CFR ch IV; 42 CFR ch V; 42 CFR subtitle 
A; 45 CFR ch II

Legal Deadline: None

Abstract: In accordance with the name change of the Health Care 
Financing Administration to the ``Centers for Medicare and Medicaid 
Services,'' this technical regulation revises all references to 
``Health Care Financing Administration'' and ``CMS'' in chapters I, IV, 
and V of title 42 and subtitle A and chapters II and III of titles 45 
of the Code of Federal Regulations. This regulation also makes 
conforming changes to the general definitions sections.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Action                    07/31/01                    66 FR 39450
Comment Period End              10/01/01

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Margaret Teeters, Department of Health and Human 
Services, Centers for Medicare & Medicaid Services, C5-14-03, Division 
of Regulation and Issuances, 7500 Security Boulevard, Balitmore, MD 
21244
Phone: 410 786-4678

RIN: 0938-AL02
_______________________________________________________________________




1248.  PAYMENTS FOR NEW MEDICAL SERVICES AND NEW TECHNOLOGIES 
UNDER THE ACUTE CARE HOSPITAL INPATIENT PROSPECTIVE PAYMENT SYSTEM (CMS-
1176-F)

Priority: Other Significant

Legal Authority: Sec 533 of PL 106-554; Sec 1886(d) of the Social 
Security Act

CFR Citation: 42 CFR 412

Legal Deadline: Final, Statutory, October 1, 2001.

Abstract: This final rule establishes a mechanism for increased 
Medicare payments for new medical services and technologies furnished 
to Medicare beneficiaries under the acute care hospital inpatient 
prospective payment system. The rule implements section 533 of the 
Medicare, Medicaid, and SCHIP [State Children's Health Insurance 
Program] Benefits Improvement and Protection Act of 2000; and finalizes 
related regulatory provisions that were addressed in a proposed rule 
published on May 4, 2001.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            05/04/01                    66 FR 22646
NPRM Comment Period End         07/03/01
Final Action                    09/07/01                    66 FR 46902
Final Action Effective          10/09/01

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Stephen Phillips, Center for Health Plans and 
Providers, Department of Health and Human Services, Centers for 
Medicare & Medicaid Services, C4-05-27, 7500 Security Boulevard, 
Baltimore, MD 21244
Phone: 410 786-4548

RIN: 0938-AL09
_______________________________________________________________________


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


Administration for Children and Families (ACF)



_______________________________________________________________________




1249. PROGRAM PERFORMANCE STANDARDS FOR THE OPERATION OF HEAD START 
PROGRAMS

Priority: Other Significant

Legal Authority: 42 USC 9801 et seq

CFR Citation: 45 CFR 1304

Legal Deadline: None

Abstract: The education component of the Head Start Performance 
Standards will be revised to ensure the school readiness of children 
participating in a Head Start program and to assure that Head Start 
children have certain understandings in the areas of language and 
numeracy.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            02/00/02

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Governmental Jurisdictions, Organizations

Government Levels Affected: None

Agency Contact: Douglas Klafehn, Deputy Associate Commissioner, Head 
Start, Department of Health and Human Services, Administration for 
Children and Families, 330 C Street SW., Washington, DC 20447
Phone: 202 205-8569
Email: [email protected]

RIN: 0970-AB99
_______________________________________________________________________




1250. SAFEGUARDING CHILD SUPPORT AND EXPANDED FPLS INFORMATION

Priority: Substantive, Nonsignificant

Legal Authority: 42 USC 652 to 654A

CFR Citation: 45 CFR 302.25; 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, 
offset of Federal payments for purposes of collecting child support, 
and safeguarding of information. This regulation would update various

[[Page 61631]]

sections in 45 CFR chapter III to reflect the statutory changes.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/00/02

Regulatory Flexibility Analysis Required: No

Government Levels Affected: State, Local, Tribal

Agency Contact: Eileen C. Brooks, Program Specialist, Department of 
Health and Human Services, Administration for Children and Families, 
4th Floor East, OCSE, DPP, 370 L'Enfant Promenade SW., Washington, DC 
20447
Phone: 202 401-5369
Email: [email protected]

RIN: 0970-AC01
_______________________________________________________________________




1251. DEVELOPMENTAL DISABILITIES AND BILL OF RIGHTS ACT

Priority: Substantive, Nonsignificant

Legal Authority: PL 106-402; USC 15001 et seq

CFR Citation: 45 CFR 1385 to 1388

Legal Deadline: Final, Statutory, October 30, 2001.
The final rule for the ``Indicator of Progress'' must be effective by 
October 1, 2001, and all other changes to the regulation are required 
to be made by October 30, 2001.

Abstract: A notice of proposed rulemaking will be published in the 
Federal Register by October 30, 2001, 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                            12/00/01

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Governmental Jurisdictions, Organizations

Government Levels Affected: State, Local, 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
_______________________________________________________________________


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


Administration for Children and Families (ACF)



_______________________________________________________________________




1252. CONSTRUCTION AND MAJOR RENOVATION OF HEAD START AND EARLY HEAD 
START FACILITIES

Priority: Other Significant

Legal Authority: 42 USC 9801 et seq

CFR Citation: 45 CFR 1309

Legal Deadline: None

Abstract: This rule establishes procedures to be used by Head Start and 
Early Head Start agencies in requesting to use Head Start grant funds 
to construct or perform major renovation on a Head Start or Early Head 
Start Facility.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            02/08/99                     64 FR 6013
NPRM Comment Period End         04/09/99
Final Action                    12/00/01

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Governmental Jurisdictions, Organizations

Government Levels Affected: Local, Tribal

Agency Contact: Douglas Klafehn, Deputy Associate Commissioner, Head 
Start, Department of Health and Human Services, Administration for 
Children and Families, 330 C Street SW., Washington, DC 20447
Phone: 202 205-8569
Email: [email protected]

RIN: 0970-AB54
_______________________________________________________________________




1253. CHILD SUPPORT ENFORCEMENT FOR INDIAN TRIBES

Priority: Other Significant

Legal Authority: 42 USC 655(f)

CFR Citation: 45 CFR 309

Legal Deadline: None

Abstract: This rule specifies how tribes can obtain direct payments 
from the Department of Health and Human Services for provision of child 
support enforcement services if they submit a plan meeting the 
objectives of title IV-D, including establishment of paternity, 
modification and enforcement of support orders, and location of absent 
parents.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            08/21/00                    65 FR 50800
NPRM Comment Period End         12/19/00
Final Action                    06/00/02

Regulatory Flexibility Analysis Required: No

Government Levels Affected: State, Tribal

Agency Contact: Paige Biava, Division of Policy and Planning, 
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

RIN: 0970-AB73
_______________________________________________________________________




1254. CHILD SUPPORT ENFORCEMENT PROGRAM OMNIBUS CONFORMING REGULATION

Priority: Substantive, Nonsignificant

Legal Authority: 42 USC 1302

CFR Citation: 45 CFR 301 to 305

Legal Deadline: None

Abstract: This rule eliminates child support enforcement program 
regulations rendered obsolete or inconsistent with the Personal 
Responsibility and Work Opportunity Reconciliation Act of 1996, and its 
technical amendments, the Balanced Budget Act of 1997, the Adoption and 
Safe Families Act of 1997, and the Child Support Performance and 
Incentive Act of 1998.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              02/09/99                     64 FR 6237
Final Action                    02/00/02

Regulatory Flexibility Analysis Required: No

[[Page 61632]]

Government Levels Affected: State

Agency Contact: Eileen C. Brooks, Program Specialist, Department of 
Health and Human Services, Administration for Children and Families, 
4th Floor East, OCSE, DPP, 370 L'Enfant Promenade SW., Washington, DC 
20447
Phone: 202 401-5369
Email: [email protected]

RIN: 0970-AB81
_______________________________________________________________________




1255. FAMILY CHILD CARE PROGRAM OPTION FOR HEAD START PROGRAMS

Priority: Substantive, Nonsignificant

Legal Authority: 42 USC 9801 et seq

CFR Citation: 45 CFR 1304; 45 CFR 1306

Legal Deadline: None

Abstract: This rule would allow Head Start programs to choose Family 
Child Care as a Head Start program option.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            08/29/00                    65 FR 52394
Final Action                    02/00/02

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Governmental Jurisdictions, Organizations

Government Levels Affected: State, Local, Tribal

Agency Contact: Douglas Klafehn, Deputy Associate Commissioner, Head 
Start, Department of Health and Human Services, Administration for 
Children and Families, 330 C Street SW., Washington, DC 20447
Phone: 202 205-8569
Email: [email protected]

RIN: 0970-AB90
_______________________________________________________________________




1256. TECHNICAL REVISION OF HEAD START REGULATIONS TO MAKE THEM CONFORM 
TO RECENT STATUTORY REVISIONS

Priority: Substantive, Nonsignificant

Legal Authority: 42 USC 9801 et seq

CFR Citation: 45 CFR 1301 to 1303; 45 CFR 1308

Legal Deadline: None

Abstract: This rule will correct several Head Start regulations that 
define Head Start programs as ``nonprofit'' agencies. Recent statutory 
changes now allow ``for-profit'' agencies to receive Head Start grant 
funds.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              02/00/02

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses, Governmental Jurisdictions, 
Organizations

Government Levels Affected: None

Agency Contact: Douglas Klafehn, Deputy Associate Commissioner, Head 
Start, Department of Health and Human Services, Administration for 
Children and Families, 330 C Street SW., Washington, DC 20447
Phone: 202 205-8569
Email: [email protected]

RIN: 0970-AC00
_______________________________________________________________________




1257. HIGH PERFORMANCE BONUS AWARDS UNDER THE TANF PROGRAM

Priority: Substantive, Nonsignificant

Legal Authority: 42 USC 603(a)(4)

CFR Citation: 45 CFR 270

Legal Deadline: None

Abstract: This final rule specifies how we will implement the child 
care measure for awarding high performance bonuses to States in FY 2002 
and FY 2003 under the Temporary Assistance for Needy Families (TANF) 
program.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              05/10/01                    66 FR 23854
Final Rule                      12/00/01

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: State

Agency Contact: Stephanie Fanjul, Deputy Associate Commissioner for 
Child Care, Department of Health and Human Services, Administration for 
Children and Families, Room 2046, 330 C Street SW., Washington, DC 
20201
Phone: 202 690-6782
Email: [email protected]

RIN: 0970-AC06
_______________________________________________________________________


Department of Health and Human Services (HHS)         Completed Actions


Administration for Children and Families (ACF)



_______________________________________________________________________




1258. INDIVIDUAL DEVELOPMENT ACCOUNTS

Priority: Substantive, Nonsignificant

CFR Citation: 45 CFR 1000

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    09/25/01                    66 FR 48970

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Sheldon Shalit
Phone: 202 401-4807

RIN: 0970-AC08

[[Page 61633]]

_______________________________________________________________________


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


Administration on Aging (AOA)



_______________________________________________________________________




1259. GRANTS FOR STATE AND COMMUNITY PROGRAMS ON AGING, TRAINING, 
RESEARCH AND DISCRETIONARY PROGRAMS; VULNERABLE ELDER RIGHTS; AND GRANTS 
TO INDIANS AND NATIVE HAWAIIANS

Priority: Substantive, Nonsignificant

Legal Authority: 42 USC 3001 et seq

CFR Citation: 45 CFR 1321; 45 CFR 1326 to 1328

Legal Deadline: None

Abstract: In response to the recent reauthorization of the Older 
Americans Act, Public Law 106-501, the Administration on Aging (AoA) 
proposes to issue a Notice of Proposed Rulemaking by the early part of 
2002.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            04/00/02

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses, Governmental Jurisdictions

Government Levels Affected: State, Tribal

Federalism:  Undetermined

Additional Information: Incorrectly reported as under Section 610 
Review in April 2001.

Agency Contact: Edwin Walker, Director, Office of Program Operations 
and Development, Department of Health and Human Services, 
Administration on Aging, Room 4733, 330 Independence Avenue SW., Cohen 
Building, Washington, DC 20201
Phone: 202 619-0011

RIN: 0985-AA00
_______________________________________________________________________


Department of Health and Human Services (HHS)         Completed Actions


Administration on Aging (AOA)



_______________________________________________________________________




1260. GRANTS FOR STATE AND COMMUNITY PROGRAMS ON AGING, FAMILY 
CAREGIVERS, AMERICAN INDIANS, AND NATIVE HAWAIIANS

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Duplicate of 0985-AA00          08/24/01

RIN: 0985-AA01
[FR Doc. 01-27742 Filed 11-30-01; 8:45 am]
BILLING CODE 4150-24-S
