[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; Subtitle B, Chs. II, III, and XIII

Unified Agenda of Federal Regulatory and Deregulatory Actions

AGENCY: Office of the Secretary, HHS.

ACTION: Semiannual agenda.

_______________________________________________________________________

SUMMARY: The Regulatory Flexibility Act of 1980 and Executive Order 
12866 require the semiannual publication of an inventory of all 
rulemakings that will be under development or review. The purpose of 
this effort is to encourage public participation in the regulatory 
process by providing, at an early stage, summarized information about 
regulatory actions that the Department is working on. All persons 
interested in communicating to the Department their views on the 
rulemakings prospectively outlined below are invited to do so.

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

SUPPLEMENTARY INFORMATION: The capsulized information provided below 
reflects an effort to present for public scrutiny a forecast of the 
rulemaking activities that the Department expects to undertake over the 
foreseeable future. We focus primarily on those areas of work expected 
to result in publication of an advance notice of proposed rulemaking, a 
notice of proposed rulemaking, or a final rule within the next 12 
months. (Also included in several ``long-term actions'' sections are 
summaries of actions that we will probably not take any earlier than 12 
months after publication of the agenda.) We welcome hearing the views 
of all concerned with regard to all of these planned rulemakings. 
Comments may be directed to the agency officials cited in each of the 
summaries, or, if early attention at the Secretary's level is believed 
to be warranted, comments should be directed to: Ann C. Agnew, 
Executive Secretary to the Department, Room 603H, 200 Independence 
Avenue SW., Washington, DC 20201.

     The Office of Management and Budget requires that fall 
editions of the agenda be augmented by a regulatory plan, 
highlighting the most important regulatory actions under 
development by the Department. Our Plan appears in part II of this 
issue of the Federal Register, along with those of other 
Departments and agencies. Our 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: September 27, 2002.

 Ann C. Agnew,

Executive Secretary to the Department.

                                  Office of the Secretary--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
907         Safe Harbor for Arrangements Involving Federally Qualified Health Centers...........     0991-AB06
908         Tax Refund Offset...................................................................     0991-AB17
909         Claims Collection...................................................................     0991-AB18
910         Salary Offset.......................................................................     0991-AB19
----------------------------------------------------------------------------------------------------------------


                                    Office of the Secretary--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
911         Shared Risk Exception to the Safe Harbor Provisions.................................     0991-AA91
912         Safe Harbor for Waiver of Beneficiary Coinsurance and Deductible Amounts for a           0991-AB16
            Medicare SELECT Policy..............................................................
913         Administrative Wage Garnishment.....................................................     0991-AB20
914         U.S. Exchange Visitor Programs; Request for Waiver of the Two-Year Foreign Residence     0991-AB21
            Requirement.........................................................................
915         Implementation of the Equal Access to Justice Act in Agency Proceedings.............     0991-AB22
----------------------------------------------------------------------------------------------------------------


                                   Office of the Secretary--Long-Term Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
916         Revisions to 42 CFR Part 1003.......................................................     0991-AB03
917         Civil Money Penalty Safe Harbor To Protect Payment of Medicare and Medigap Premiums      0991-AB04
            for ESRD Beneficiaries..............................................................
918         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.........................................................................
919         Governmentwide Debarment and Suspension (Nonprocurement) and Governmentwide              0991-AB12
            Requirements for Drug-Free Workplace (Grants).......................................
----------------------------------------------------------------------------------------------------------------


[[Page 74493]]


                                   Office of the Secretary--Completed Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
920         Modifications to Standards for Privacy of Individually Identifiable Health               0991-AB14
            Information.........................................................................
921         Implementing the Bioterrorism Prevention and Response Act of 2001...................     0991-AB15
----------------------------------------------------------------------------------------------------------------


                  Substance Abuse and Mental Health Services Administration--Long-Term Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
922         Seclusion and Restraint for Non-Medical Residential Facilities......................     0930-AA10
----------------------------------------------------------------------------------------------------------------


                         Centers for Disease Control and Prevention--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
923         Control of Communicable Diseases (Reg Plan Seq No. 29)..............................     0920-AA03
924         Amendments to Quality Assurance and Administrative Provision for Approval of             0920-AA04
            Respiratory Protective Devices......................................................
----------------------------------------------------------------------------------------------------------------
References in boldface appear in the Regulatory Plan in part II of this issue of the Federal Register.


                          Centers for Disease Control and Prevention--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
925         Procedures for Designating Classes of Employees as Members of the Special Exposure       0920-AA07
            Cohort Under the Energy Employee Occupational Illness Compensation Act of 2000......
926         Possession, Use, and Transfer of Select Agents (Reg Plan Seq No. 30)................     0920-AA08
----------------------------------------------------------------------------------------------------------------
References in boldface appear in the Regulatory Plan in part II of this issue of the Federal Register.


                          Centers for Disease Control and Prevention--Completed Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
927         Methods for Estimating Radiation Dose and Guidelines for Assessing Probability of        0920-AA05
            Cancer for Energy Employees Occupational Illness Compensation Program...............
----------------------------------------------------------------------------------------------------------------


                                   Departmental Management--Completed Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
928         Implementation of the Equal Access to Justice Act in Agency Proceedings.............     0990-AA02
929         Administrative Wage Garnishment.....................................................     0990-AA05
----------------------------------------------------------------------------------------------------------------


                                   Food and Drug Administration--Prerule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
930         Requirements for Submission of In Vivo Bioequivalence Data..........................     0910-AC23
----------------------------------------------------------------------------------------------------------------


[[Page 74494]]


                                Food and Drug Administration--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
931         Establishment Registration and Listing for Drugs and Biologics......................     0910-AA49
932         Safety Reporting Requirements for Human Drug and Biological Products (Reg Plan Seq       0910-AA97
            No. 31).............................................................................
933         Blood Initiative....................................................................     0910-AB26
934         Applications for FDA Approval to Market a New Drug; Complete Response Letter;            0910-AB34
            Amendments to Unapproved Applications...............................................
935         Current Good Manufacturing Practice for Medicated Feeds.............................     0910-AB70
936         Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Dietary        0910-AB88
            Ingredients and Dietary Supplements (Reg Plan Seq No. 32)...........................
937         Requirements Pertaining to Sampling Services and Private Laboratories Used in            0910-AB96
            Connection With Imported Food.......................................................
938         Control of Salmonella Enteritidis in Shell Eggs During Production and Retail (Reg        0910-AC14
            Plan Seq No. 33)....................................................................
939         Institutional Review Boards: Registration Requirements..............................     0910-AC17
940         Chronic Wasting Disease: Control of Food Products and Cosmetics Derived From Exposed     0910-AC21
            Animal Populations..................................................................
941         Exception From General Requirements for Informed Consent; Request for Comments and       0910-AC25
            Information (Reg Plan Seq No. 34)...................................................
942         Bar Code Label Requirements for Human Drug Products (Reg Plan Seq No. 35)...........     0910-AC26
943         Medical Devices; Patient Examination and Surgeons' Gloves; Adulteration.............     0910-AC32
944         Amendments to the Performance Standard for Diagnostic X-Ray Systems and Their Major      0910-AC34
            Components..........................................................................
945         Administrative Detention (Reg Plan Seq No. 36)......................................     0910-AC38
946         Establishment and Maintenance of Records to Identify Immediate Previous Source and       0910-AC39
            Immediate Subsequent Recipient of Foods (Reg Plan Seq No. 37).......................
947         Registration of Food and Animal Feed Facilities (Reg Plan Seq No. 38)...............     0910-AC40
948         Establishment of Prior Notification Requirement for All Imported Food Shipments (Reg     0910-AC41
            Plan Seq No. 39)....................................................................
949         Requirements for Liquid Medicated Feed and Free-Choice Medicated Feed...............     0910-AC43
950         Applications for FDA Approval to Market a New Drug: Patent Listing Requirements and      0910-AC48
            Application of 30-Month Stays on Approval of Abbreviated New Drug Applications (Reg
            Plan Seq No. 40)....................................................................
----------------------------------------------------------------------------------------------------------------
References in boldface appear in the Regulatory Plan in part II of this issue of the Federal Register.


                                 Food and Drug Administration--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
951         Over-the-Counter (OTC) Drug Review..................................................     0910-AA01
952         Investigational New Drugs: Export Requirements for Unapproved New Drug Products.....     0910-AA61
953         Determination That Informed Consent Is Infeasible or Is Contrary to the Best             0910-AA89
            Interest of Recipients..............................................................
954         Labeling for Human Prescription Drugs; Revised Format (Reg Plan Seq No. 41).........     0910-AA94
955         Revisions to the General Safety Requirements for Biological Products; Final Rule....     0910-AB51
956         Supplements and Other Changes to an Approved Application............................     0910-AB61
957         Food Labeling: Trans Fatty Acids in Nutrition Labeling, Nutrient Content Claims, and     0910-AB66
            Health Claims (Reg Plan Seq No. 42).................................................
958         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. 43)................................................
959         Antibiotic Resistance Labeling......................................................     0910-AB78
960         Requirements for Submission of Labeling for Human Prescription Drugs and Biologics       0910-AB91
            in Electronic Format................................................................
961         Additional Safeguards for Children in Clinical Investigations of FDA Regulated           0910-AC07
            Products............................................................................
962         Aluminum in Large- and Small-Volume Parenterals Used in Total Parenteral Nutrition..     0910-AC18
963         Toll-Free Number for Reporting Adverse Events on Labeling for Human Drugs (Reg Plan      0910-AC35
            Seq No. 44).........................................................................
964         Records and Reports Concerning Experience With Approved New Animal Drugs............     0910-AC42
965         Presubmission Conferences...........................................................     0910-AC44
966         Regulation of Carcinogenic Compounds Used in Food-Producing Animals; Definition of       0910-AC45
            ``No Residue''......................................................................
967         Bioavailability and Bioequivalence Requirements.....................................     0910-AC47
----------------------------------------------------------------------------------------------------------------
References in boldface appear in the Regulatory Plan in part II of this issue of the Federal Register.


[[Page 74495]]


                                 Food and Drug Administration--Long-Term Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
968         Infant Formula: Requirements Pertaining to Good Manufacturing Practice, Quality          0910-AA04
            Control Procedures, Quality Factors, Notification Requirements, and Records and
            Reports.............................................................................
969         Investigational Use New Animal Drug Regulations (Section 610 Review)................     0910-AB02
970         Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and           0910-AB27
            Tissue-Based Products (HCT/Ps)......................................................
971         Current Good Tissue Practice for Manufacturers of Human Cells, Tissues, and Cellular     0910-AB28
            and Tissue-Based Products (HCT/Ps); Inspection and Enforcement......................
972         Premarket Notice Concerning Bioengineered Foods.....................................     0910-AC15
973         Use of Materials Derived From Bovine and Ovine Animals in FDA-Regulated Products....     0910-AC19
974         Medical Devices; Anesthesiology Devices; Proposed Reclassification of Pressure           0910-AC30
            Regulators for Use With Medical Oxygen..............................................
----------------------------------------------------------------------------------------------------------------


                                 Food and Drug Administration--Completed Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
975         Use of Ozone-Depleting Substances...................................................     0910-AA99
976         Food Additives: Food Contact Substances Notification System.........................     0910-AB94
977         Efficacy Evidence Needed for Products To Be Used Against Toxic Substances When Human     0910-AC05
            Studies Are Unethical...............................................................
978         Revocation of Conditions for Marketing Digoxin Products for Oral Use................     0910-AC12
979         Postmarket Surveillance.............................................................     0910-AC31
----------------------------------------------------------------------------------------------------------------


                                                   Food and Drug Administration--Discontinued Entries
--------------------------------------------------------------------------------------------------------------------------------------------------------
  Regulation
Identification                                             Title                                                  Date                 Comments
    Number
--------------------------------------------------------------------------------------------------------------------------------------------------------
0910-AB24        FDA Export Reform and Enhancement Act of 1996; Reporting and Recordkeeping Requirements        08/02/2002   Withdrawn
                 for Unapproved or Violative Products Imported for Further Processing or Incorporation and
                 Later Export
0910-AB95        Marking Requirements for and Prohibitions on the Reimportation of Imported Food Products       08/02/2002   Withdrawn
                 That Have Been Refused Admission Into the United States
0910-AC04        Status Reports of Distribution and Use Information for Antimicrobial Animal Drug Products      07/31/2002   Withdrawn
                 Used in Food-Producing Animals
0910-AC20        Postmarketing Reports of Substandard or Ineffective Bulk Ingredients and Bulk Ingredients      08/02/2002   Withdrawn
                 From Unapproved Sources
0910-AC33        Redacting 510(k) Submissions                                                                   09/18/2002   Withdrawn
--------------------------------------------------------------------------------------------------------------------------------------------------------


                        Health Resources and Services Administration--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
980         National Practitioner Data Bank for Adverse Information on Physicians and Other          0906-AA41
            Health Care Practitioners: Medical Malpractice Payments Reporting Requirements......
981         Designation of Medically Underserved Populations and Health Professional Shortage        0906-AA44
            Areas...............................................................................
982         National Practitioner Data Bank for Adverse Information on Physicians and Other          0906-AA57
            Health Care Practitioners: Reporting Adverse and Negative Actions...................
----------------------------------------------------------------------------------------------------------------


[[Page 74496]]


                         Health Resources and Services Administration--Completed Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
983         National Vaccine Injury Compensation Program: Revisions and Additions to the Vaccine     0906-AA55
            Injury Table........................................................................
----------------------------------------------------------------------------------------------------------------


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


                                    Indian Health Service--Completed Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
985         Tribal Self-Governance Amendments...................................................     0917-AA05
----------------------------------------------------------------------------------------------------------------


                               National Institutes of Health--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
986         Undergraduate Scholarship Program Regarding Professions Needed by the National           0925-AA10
            Institutes of Health (NIH)..........................................................
987         National Institutes of Health (NIH) Center Grants...................................     0925-AA24
988         National Institutes of Health (NIH) Training Grants.................................     0925-AA28
989         National Institutes of Health (NIH) Aids Research Loan Repayment Program............     0925-AA32
----------------------------------------------------------------------------------------------------------------


                                 National Institutes of Health--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
990         National Institutes of Health Loan Repayment Program for Research Generally.........     0925-AA18
991         Scientific Peer Review of Research Grant Applications and Research and Development       0925-AA20
            Contract Projects...................................................................
----------------------------------------------------------------------------------------------------------------


                                National Institutes of Health--Long-Term Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
992         Standards for a National Chimpanzee Sanctuary System................................     0925-AA31
----------------------------------------------------------------------------------------------------------------


                            Office of Public Health and Science--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
993         Public Health Services Policies on Research Misconduct..............................     0940-AA04
994         Human Subjects Protection Regulations: Institutional Review Boards Registration          0940-AA06
            Requirements........................................................................
----------------------------------------------------------------------------------------------------------------


[[Page 74497]]


                              Office of Public Health and Science--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
995         Public Health Service Standards for the Protection of Research Misconduct                0940-AA01
            Whistleblowers......................................................................
----------------------------------------------------------------------------------------------------------------


                          Centers for Medicare & Medicaid Services--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
996         End Stage Renal Disease (ESRD) Conditions for Coverage (CMS-3818-P) (Section 610         0938-AG82
            Review) (Reg Plan Seq No. 45).......................................................
997         Criteria for Approval of Facilities to Perform Covered Heart, Liver, Lung, Pancreas,     0938-AH17
            and Intestinal Transplants (CMS-3835-P).............................................
998         Hospice Care--Conditions of Participation (CMS-3844-P)..............................     0938-AH27
999         Requirements for Establishing and Maintaining Medicare Billing Privileges (CMS-6002-     0938-AH73
            P)..................................................................................
1000        National Standard for Identifiers of Health Plans (CMS-6017-P) (Reg Plan Seq No. 46)     0938-AH87
1001        Medical Child Support and Health Insurance Coverage of Dependent Children (CMS-2081-     0938-AI21
            P)..................................................................................
1002        Medicare Hospice Care Amendments (CMS-1022-P).......................................     0938-AJ36
1003        Supplier Standards for Home Oxygen, Therapeutic Shoes, Home Nutrition Therapy (CMS-      0938-AJ98
            6010-P).............................................................................
1004        All Provider Bad Debt Payment (CMS-1126-P)..........................................     0938-AK02
1005        Conditions of Participation of Intermediate Care Facilities for Persons With Mental      0938-AK23
            Retardation (CMS-3046-P)............................................................
1006        Health Insurance Reform: Claims Attachments Standards (CMS-0050-P) (Reg Plan Seq No.     0938-AK62
            47).................................................................................
1007        Rate of Reimbursement of Photocopy Expenses for Prospective Payment System Providers     0938-AK68
            (CMS-3055-P)........................................................................
1008        Modifications to Medicare Managed Care Rules (CMS-4041-P)...........................     0938-AK71
1009        Medicare Inpatient Disproportionate Share Hospital (DSH) Adjustment Formula (CMS-        0938-AK77
            1171-P).............................................................................
1010        Elimination of Statement of Intent Procedures for Filing Medicare Claims (CMS-1185-      0938-AK79
            P)..................................................................................
1011        Organ Procurement Organization Conditions for Coverage (CMS-3064-P) (Reg Plan Seq        0938-AK81
            No. 48).............................................................................
1012        Extending Medicare Entitlement When Disability Benefit Entitlement Ends Because of       0938-AK94
            Substantial Gainful Activity (CMS-4018-P)...........................................
1013        Update Interest Assessment on Medicare Overpayment and Underpayment (CMS-6014-P)....     0938-AL14
1014        Use of Restraint and Seclusion in Medicare and Medicaid Participating Facilities         0938-AL26
            that Provide Inpatient or Residential Care (CMS-2130-P) (Reg Plan Seq No. 49).......
1015        Payment for Respiratory Assist Devices with Bi-Level Capability and a Back-Up Rate       0938-AL27
            (CMS-1167-P)........................................................................
1016        Self-Declaration of Citizenship (CMS-2085-P)........................................     0938-AL33
1017        Permitting Premium Reductions as Additional Benefits Under Medicare+Choice Plans         0938-AL49
            (CMS-6016-P)........................................................................
1018        Prospective Payment System for Psychiatric Hospitals (CMS-1213-P) (Reg Plan Seq No.      0938-AL50
            50).................................................................................
1019        Provider Reimbursement Determinations and Appeals (CMS-1727-P)......................     0938-AL54
1020        SCHIP; Purchase of Family Coverage--Benefit Flexibility in Parent Coverage (CMS-2148-    0938-AL62
            P)..................................................................................
1021        Request for Information on Benefit-Specific Waiting Periods (CMS-2150-N)............     0938-AL64
1022        Revisions to the Medicare Appeals Process (CMS-4004-P) (Reg Plan Seq No. 51)........     0938-AL67
1023        DMERC Service Areas and Related Matters (CMS-1219-P)................................     0938-AL76
1024        Revisions to Conditions for Coverage for Ambulatory Surgical Centers (CMS-3887-P)...     0938-AL80
1025        Medicaid Coverage Rules for Inmates of Public Institutions (CMS-2077-P).............     0938-AL85
1026        Targeted Case Management (CMS-2061-P)...............................................     0938-AL87
1027        Health Coverage Portability: Tolling Certain Time Periods and Interactions With          0938-AL88
            Family and Medical Leave Act (CMS-2158-P)...........................................
1028        Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities--     0938-AL90
            Update for FY 2004 (CMS-1469-P) (Reg Plan Seq No. 52)...............................
1029        Changes to the Hospital Outpatient Prospective Payment System and Calendar Year 2004     0938-AL91
            Payment Rates (CMS-1471-P) (Reg Plan Seq No. 53)....................................
1030        Prospective Payment System for Long-Term Care Hospitals: FY 2004 (CMS-1472-P).......     0938-AL92
1031        Home Health Prospective Payment System Rate Update for FY 2004 (CMS-1473-NC)........     0938-AL94
1032        Prospective Payment System for Inpatient Rehabilitation Hospitals (CMS-1474-P)......     0938-AL95
1033        Revisions to Payment Policies Under the Physician Fee Schedule for Calendar Year         0938-AL96
            2004 (CMS-1476-P) (Reg Plan Seq No. 54).............................................
1034        Nondiscrimination In Post-Hospital Referral to Home Health Agencies and Other            0938-AM01
            Entities (CMS-1224-P)...............................................................
1035        Medicaid Home and Community-Based Services Waivers (CMS-2162-P).....................     0938-AM05
1036        Ticket to Work Medicaid Infrastructure Grant (CMS-2165-N)...........................     0938-AM11
1037        Revisions to Average Wholesale Price Methodology (CMS-1229-P) (Reg Plan Seq No. 55).     0938-AM12
1038        Criteria for Determining Whether a Drug is Considered Usually Self-Administered (CMS-    0938-AM13
            1228-P).............................................................................

[[Page 74498]]

 
1039        Electronic Medicare Claims Submission (CMS-0008-P) (Reg Plan Seq No. 56)............     0938-AM22
1040        Liability of Third Parties to Pay for Care and Services (CMS-2080-P)................     0938-AM24
1041        Medicaid Definition of Qualified Speech Pathologists and Audiologists (CMS-2132-P)..     0938-AM26
1042        Medicaid Estate Recoveries (CMS-2083-P).............................................     0938-AM30
----------------------------------------------------------------------------------------------------------------
References in boldface appear in the Regulatory Plan in part II of this issue of the Federal Register.


                           Centers for Medicare & Medicaid Services--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
1043        Revision of Medicare/Medicaid Hospital Conditions of Participation (CMS-3745-F) (Reg     0938-AG79
            Plan Seq No. 57)....................................................................
1044        Home Health Agency (HHA) Conditions of Participation (CoPs) (CMS-3819-FC)...........     0938-AG81
1045        Medicare and Medicaid Programs; Terms, Definitions, and Addresses: Technical             0938-AH53
            Amendments (CMS-9877-F).............................................................
1046        Health Insurance Reform: Standard Unique Health Care Provider Identifier (CMS-0045-      0938-AH99
            F) (Reg Plan Seq No. 58)............................................................
1047        Appeals of Carrier Determination That a Supplier Fails To Meet the Requirements for      0938-AI49
            Medicare Billing Privileges (CMS-6003-F)............................................
1048        Security Standards (CMS-0049-F) (Reg Plan Seq No. 59)...............................     0938-AI57
1049        Coverage of Religious Non-Medical Health Care Institutions (CMS-1909-F).............     0938-AI93
1050        External Quality Review of Medicaid Managed Care Organizations (CMS-2015-F).........     0938-AJ06
1051        Reporting Outcome and Assessment Information Set (OASIS) Data as Part of the             0938-AJ10
            Conditions of Participation for Home Health Agencies (CMS-3006-IFC).................
1052        Rural Health Clinics: Amendments to Participation Requirements and Payment               0938-AJ17
            Provisions, and Establishment of a Quality Assessment and Improvement Program (CMS-
            1910-F).............................................................................
1053        Hospital Conditions of Participation: Laboratory Services (CMS-3014-F)..............     0938-AJ29
1054        Use of Restraint and Seclusion in Residential Treatment Facilities Providing             0938-AJ96
            Inpatient Psychiatric Services to Individuals Under Age 21 (CMS-2065-F).............
1055        Application of Inherent Reasonableness to All Medicare Part B Services (Other than       0938-AJ97
            Physician Services) (CMS-1908-F)....................................................
1056        Clinical Lab Requirements--Revisions to Regulations Implementing CLIA (CMS-2226-F)..     0938-AK24
1057        Fire Safety Requirements for RNHCI, ASC, Hospices, PACE, Hospitals, and Long-Term        0938-AK35
            Care Facilities and ICFs for the Mentally Retarded (CMS-3047-F).....................
1058        Hospital Conditions of Participation: Quality Assessment and Performance                 0938-AK40
            Improvements (QAPI) (CMS-3050-F) (Reg Plan Seq No. 60)..............................
1059        Improvements to the Medicare+Choice Appeals and Grievance Procedures (CMS-4024-F)...     0938-AK48
1060        Review of National Coverage Determinations and Local Coverage Determinations (CMS-       0938-AK60
            3063-F) (Reg Plan Seq No. 61).......................................................
1061        Revised Process for Making Medicare Coverage Determinations (NCDs) (CMS-3062-N).....     0938-AK61
1062        Health Insurance Reform: Modifications to Standards for Electronic Transactions (CMS-    0938-AK64
            0003-F) (Reg Plan Seq No. 62).......................................................
1063        Physicians' Referrals to Health Care Entities With Which They Have Financial             0938-AK67
            Relationships--Phase II (CMS-1810-FC)...............................................
1064        Medicaid Managed Care; New Provisions (CMS-2104-F2).................................     0938-AK96
1065        Modifications to the State Children's Health Insurance Program (CMS-2006-F).........     0938-AL00
1066        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)........................................................................
1067        Requirements for Paid Feeding Assistants in Long-Term Care Facilities (CMS-2131-F)..     0938-AL18
1068        Changes to the Hospital Outpatient Prospective Payment System and Calendar Year 2003     0938-AL19
            Payment Rates (CMS-1206-F)..........................................................
1069        Revisions to Payment Policies Under the Physician Fee Schedule for Calendar Year         0938-AL21
            2003 (CMS-1204-FC)..................................................................
1070        Health Coverage Portability for Group Health Plans and Group Health Insurance            0938-AL43
            Issuers (CMS-2151-F)................................................................
1071        Interim Final Amendment for Mental Health Parity (CMS-2152-IFC).....................     0938-AL44
1072        Electronic Submission of Cost Reports (CMS-1199-F)..................................     0938-AL51
1073        Inpatient Hospital Deductible and Hospital and Extended Care Services Coinsurance        0938-AL56
            Amounts for Calendar Year 2003 (CMS-8013-N).........................................
1074        Program for All-Inclusive Care for the Elderly (PACE): Program Revisions (CMS-1201-      0938-AL59
            F)..................................................................................
1075        Monthly Actuarial Rates and Monthly Supplementary Medical Insurance Premium Rate         0938-AL63
            Beginning January 1, 2003 (CMS-8014-N)..............................................

[[Page 74499]]

 
1076        Part A Premiums for 2003 for the Uninsured Aged and for Certain Disabled Individuals     0938-AL69
            Who Have Exhausted Other Entitlement (CMS-8015-N)...................................
1077        State Allotments for Payment of Medicare Part B Premiums for Qualifying Individuals;     0938-AL79
            Federal Fiscal Year 2002 (CMS-2136-FN)..............................................
1078        Changes to the Hospital Inpatient Prospective Payment System and FY 2004 Rates (CMS-     0938-AL89
            1470-N) (Reg Plan Seq No. 63).......................................................
1079        Fee Schedule for Payment of Ambulance Services--Update for CY 2003 (CMS-1220-N).....     0938-AL97
1080        Update of the List of Covered Procedures for Ambulatory Surgical Centers Effective       0938-AM02
            January 1, 2003 (CMS-1885-FC).......................................................
1081        Comprehensive Employment Demonstration (CMS-2163-N).................................     0938-AM10
1082        Nondiscrimination in Health Coverage in the Group Market (CMS-2022-F)...............     0938-AM14
1083        Bona Fide Wellness Programs (CMS-2078-F)............................................     0938-AM15
1084        Time Limitation on Recalculations and Disputes Under the Drug Rebate Program (CMS-       0938-AM20
            2175-IFC)...........................................................................
1085        Physicians' Referrals to Health Care Entities With Which They Have Financial             0938-AM21
            Relationships; Extension of Partial Delay of Effective Date of the ``Set in
            Advance'' Provision (CMS-1809-IFC2).................................................
1086        Inpatient Hospital Deductible and Hospital and Extended Care Services Coinsurance        0938-AM31
            Amounts for 2004 (CMS-8016-N).......................................................
1087        Monthly Actuarial Rates and Monthly Supplementary Medical Insurance Premium Rate         0938-AM32
            Beginning January 1, 2004 (CMS-8017-N)..............................................
1088        Part A Premiums for 2004 for the Uninsured Aged and for Certain Disabled Individuals     0938-AM33
            Who Have Exhausted Other Entitlement (CMS-8018-N)...................................
1089        Application of Emergency Medical and Treatment Act (EMTALA) (CMS-1063-F) (Reg Plan       0938-AM34
            Seq No. 64).........................................................................
----------------------------------------------------------------------------------------------------------------
References in boldface appear in the Regulatory Plan in part II of this issue of the Federal Register.


                           Centers for Medicare & Medicaid Services--Completed Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
1090        National Standard Employer Identifier (CMS-0047-F)..................................     0938-AI59
1091        Non-Federal Governmental Plans Exempt From Health Insurance Portability Requirements     0938-AK00
            (CMS-2033-F)........................................................................
1092        Supplementary Medical Insurance Premium Surcharge Agreements (CMS-1221-F)...........     0938-AK42
1093        Payment for Upgraded Durable Medical Equipment; Withdrawal of Proposed Rule (CMS-        0938-AK50
            1084-WN)............................................................................
1094        Prospective Payment System for Long-Term Care Hospitals for FY 2003 (CMS-1177-F)....     0938-AK69
1095        Revisions to Transaction and Code Set Standards for Electronic Transactions (CMS-        0938-AK76
            0005-P).............................................................................
1096        Modifications to Managed Care Rules Based on Payment Provisions in BIPA and              0938-AK90
            Technical Corrections (CMS-4040-F)..................................................
1097        Home Health Prospective Payment System Rate Update for FY 2003 (CMS-1198-NC)........     0938-AL16
1098        Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities--     0938-AL20
            Update for FY 2003 (CMS-1202-N).....................................................
1099        Inpatient Rehabilitation Facility Prospective Payment System for FY 2003 (CMS-1205-      0938-AL22
            N)..................................................................................
1100        Hospital Inpatient Prospective Payment System for FY 2003 (CMS-1203-F)..............     0938-AL23
1101        Medicare Program; Medicare-Endorsed Prescription Drug Discount Card Assistance           0938-AL28
            Initiative (CMS-4027-F).............................................................
1102        Medicare-Endorsed Prescription Drug Discount Card Assistance Initiative for State        0938-AL30
            Sponsors (CMS-4032-P)...............................................................
1103        Peer Review Organizations: Name and Other Changes--Technical Amendments (CMS-3088-       0938-AL38
            FC).................................................................................
1104        End-Stage Renal Disease--Rescission of Waiver of Conditions for Coverage Under a         0938-AL39
            State of Emergency in Houston, Texas Area (CMS-3074-F2).............................
1105        Prospective Payment System for Inpatient Rehabilitation Hospital; Correcting             0938-AL40
            Amendment (CMS-1069-F2).............................................................
1106        Hospice Wage Index for FY 2003 (CMS-1211-N).........................................     0938-AL41
1107        Physician Fee Schedule for CY 2002: Correction Notice (CMS-1169-CN).................     0938-AL48
1108        Notice of Modification of Beneficiary Assessment Requirements for Skilled Nursing        0938-AL55
            Facilities (CMS-1209-N).............................................................
1109        Revision of the Procedures for Requesting Exceptions to Cost Limits for Skilled          0938-AL61
            Nursing Facilities and Elimination of Reclassifications; Correction (CMS-1883-F3)...
1110        Notice of Intent to Conduct Negotiated Rulemaking for Special Payment Provisions and     0938-AL68
            Standards for Suppliers of Custom-Fabricated Orthotics and Prosthetics (CMS-6012-N).
1111        Medicaid Managed Care: Withdrawal (CMS-2001-F4).....................................     0938-AL83
1112        FY 1999 SCHIP Reallocation Notice (CMS-2137-N)......................................     0938-AL86

[[Page 74500]]

 
1113        Criteria for Acceptance of Supplemental Practice Expense Survey Data (CMS-1223-IFC).     0938-AL99
----------------------------------------------------------------------------------------------------------------


                                             Centers for Medicare & Medicaid Services--Discontinued Entries
--------------------------------------------------------------------------------------------------------------------------------------------------------
  Regulation
Identification                                             Title                                                  Date                 Comments
    Number
--------------------------------------------------------------------------------------------------------------------------------------------------------
0938-AD95        ''Without Fault'' and Beneficiary Waiver of Recovery As It Applies to Medicare Overpayment     09/12/2002   Withdrawn
                 Liability (CMS-6007-F)
0938-AK91        State Allotments for Payment of Medicare Part B Premiums for Qualified Individuals;            09/12/2002   Withdrawn
                 Federal Fiscal Year 2001 (CMS-2087-FN)
0938-AL37        State Children's Health Insurance Program; Eligibility for Unborn Children (CMS-2127-F)        09/12/2002   Withdrawn
0938-AL52        Health Insurance Reform: National Standard for Identifiers of Health Plans (CMS-6017-P)        08/22/2002   Withdrawn
0938-AL53        Revised Civil Money Penalties, Assessments, Exclusions, and Related Appeals Procedures         09/12/2002   Withdrawn
                 (CMS-6146-P)
0938-AL57        Definition of Severe Medically Determinable Impairment (CMS-2143-P)                            09/12/2002   Withdrawn
0938-AL66        Revisions to Medicaid Cost-Sharing Regulations (CMS-2144-P)                                    09/12/2002   Withdrawn
0938-AL72        Effect of Change of Ownership on Provider and Supplier Penalties (CMS-2215-P)                  10/10/2002   Withdrawn
0938-AL81        Flexibility in Payment Methods for Services of Hospitals, Nursing Facilities, and              09/12/2002   Withdrawn
                 Intermediate Care Facilities for the Mentally Retarded (CMS-2004-F)
0938-AL84        Continue To Allow States an Option Under the Medicaid Spousal Impoverishment Provisions To     09/12/2002   Withdrawn
                 Increase the Community Spouse's Income When Adjusting the Protected Resource Allowance
                 (CMS-2128-F)
0938-AL93        Prospective Payment System for Psychiatric Hospitals (CMS-1477-P)                              08/08/2002   Withdrawn
--------------------------------------------------------------------------------------------------------------------------------------------------------


                          Administration for Children and Families--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
1114        Safeguarding Child Support and Expanded FPLS Information............................     0970-AC01
1115        Developmental Disabilities and Bill of Rights Act...................................     0970-AC07
1116        Child Support Enforcement Program; Customer Service Annual State Self-Assessment....     0970-AC10
1117        Child Support Enforcement Program; Expenditures for Caseworker Costs................     0970-AC11
----------------------------------------------------------------------------------------------------------------


                           Administration for Children and Families--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
1118        Construction and Major Renovation of Head Start and Early Head Start Facilities.....     0970-AB54
1119        Child Support Enforcement for Indian Tribes.........................................     0970-AB73
1120        Child Support Enforcement Program Omnibus Conforming Regulation.....................     0970-AB81
1121        Family Child Care Program Option for Head Start Programs............................     0970-AB90
1122        Technical Revision of Head Start Regulations To Make Them Conform to Recent              0970-AC00
            Statutory Revisions.................................................................
1123        Child Support Enforcement Program; Federal Tax Refund Offset........................     0970-AC09
----------------------------------------------------------------------------------------------------------------


[[Page 74501]]


                           Administration for Children and Families--Completed Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
1124        Program Performance Standards for the Operation of Head Start Programs..............     0970-AB99
----------------------------------------------------------------------------------------------------------------


                                  Administration on Aging--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
1125        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...........................................................................
----------------------------------------------------------------------------------------------------------------

_______________________________________________________________________


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


Office of the Secretary (OS)



_______________________________________________________________________




907. 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 federally qualified health centers and 
certain service providers where a significant community benefit exists.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/00/02
NPRM Comment Period End         02/00/03

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

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




908. [bull] TAX REFUND OFFSET

Priority: Substantive, Nonsignificant

Legal Authority: 31 USC 3720A; 31 CFR 285.2

CFR Citation: 45 CFR 31

Legal Deadline: None

Abstract: The Department will amend part 31 to title 45 of the Code of 
Federal Regulations (CFR) to reflect amendments to 31 U.S.C. 3720A made 
by the tax refund offset provisions of the Debt Collection Improvement 
Act of 1996 (DCIA), Public Law 104-134, 110 Stat. 1321-358, as 
implemented by the Department of Treasury at 31 CFR 285.2. The proposed 
rule revises the process by which the Department collects its debts. 
The proposed rule is required in order to bring the Department's tax 
refund offset provisions in compliance with Department of Treasury 
regulations.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/00/02
NPRM Comment Period End         02/00/03

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Federalism:  Undetermined

Agency Contact: Katherine M. Drews, Associate General Counsel, 
Department of Health and Human Services, Office of the Secretary, 
Office of the General Counsel, Room 5362, HHS Cohen Building, 330 
Independence Avenue SW., Washington, DC 20201
Phone: 202 619-0150

RIN: 0991-AB17
_______________________________________________________________________




909. [bull] CLAIMS COLLECTION

Priority: Substantive, Nonsignificant

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

CFR Citation: 45 CFR 30

Legal Deadline: None

Abstract: The Department will amend part 30 of title 45 of the Code of 
Federal Regulations (CFR) to reflect the amendments to the Federal 
Claims Collection Act made by the Debt Collection Improvement Act of 
1996 (DCIA), Public Law 104-134, 110 Stat. 1321 to 1358, as implemented 
by the Department of Treasury at 31 CFR 900-904. The proposed rule will 
prescribe the standards and procedures for the Department's use in the 
administrative collection, offset, compromise and suspension or 
termination of debts owed to the Department. The proposed rule is 
required in order to bring the Department's claims collection 
provisions in compliance with Department of Treasury regulations.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            01/00/03
NPRM Comment Period End         03/00/03
Final Rule                      06/00/03

Regulatory Flexibility Analysis Required: No

[[Page 74502]]

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Katherine M. Drews, Associate General Counsel, 
Department of Health and Human Services, Office of the Secretary, 
Office of the General Counsel, Room 5362, HHS Cohen Building, 330 
Independence Avenue SW., Washington, DC 20201
Phone: 202 619-0150

RIN: 0991-AB18
_______________________________________________________________________




910. [bull] SALARY OFFSET

Priority: Substantive, Nonsignificant

Unfunded Mandates: Undetermined

Legal Authority: Not Yet Determined

CFR Citation: Not Yet Determined

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            01/00/03
NPRM Comment Period End         03/00/03
Final Rule                      06/00/03

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Katherine M. Drews, Associate General Counsel, 
Department of Health and Human Services, Office of the Secretary, 
Office of the General Counsel, Room 5362, HHS Cohen Building, 330 
Independence Avenue SW., Washington, DC 20201
Phone: 202 619-0150

RIN: 0991-AB19
_______________________________________________________________________


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


Office of the Secretary (OS)



_______________________________________________________________________




911. 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                      02/00/03

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Additional Information: Interim final regulations were published on 
November 19, 1999 (64 FR 63504) and are currently in effect. See 42 CFR 
1001.952(t) and (u).

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

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




912. [bull] SAFE HARBOR FOR WAIVER OF BENEFICIARY COINSURANCE AND 
DEDUCTIBLE AMOUNTS FOR A MEDICARE SELECT POLICY

Priority: Substantive, Nonsignificant

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

CFR Citation: 42 CFR 1001

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/25/02                    67 FR 60202
NPRM Comment Period End         10/25/02
Final Rule                      04/00/03

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-AB16

[[Page 74503]]

_______________________________________________________________________




913. ADMINISTRATIVE WAGE GARNISHMENT

Priority: Substantive, Nonsignificant

Legal Authority: 31 USC 3720D; 31 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 to 1358, 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                            03/13/02                    67 FR 11264
NPRM Comment Period End         05/13/02
Final Rule                      11/00/02

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Additional Information: Transferred from RIN 0990-AA05

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

Katherine M. Drews, Associate General Counsel, Department of Health and 
Human Services, Office of the Secretary, Office of the General Counsel, 
Room 5362, HHS Cohen Building, 330 Independence Avenue SW., Washington, 
DC 20201
Phone: 202 619-0150

Related RIN: Previously reported as 0990-AA05
RIN: 0991-AB20
_______________________________________________________________________




914. [bull] U.S. EXCHANGE VISITOR PROGRAMS; REQUEST FOR WAIVER OF THE 
TWO-YEAR FOREIGN RESIDENCE REQUIREMENT

Priority: Other Significant

Legal Authority: 22 USC 2451 et seq; 8 USC 1182(e)

CFR Citation: 45 CFR 50

Legal Deadline: None

Abstract: This regulation will expand the Department's role in 
requesting waivers of the two year foreign residence requirement. HHS 
previously only requested waivers for J-1 visa holders for research. 
This will permit the review of applications based on 40 hours per week 
primary care in an HHS-designated health manpower shortage area or a 
medically underserved area.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              01/00/03

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: State

Agency Contact: Joyce Edith Jones, International Affairs Specialist, 
Department of Health and Human Services, Office of the Secretary, Room 
639H, 200 Independence Avenue SW., Washington, DC 20201
Phone: 202 690-6174
Fax: 202 690-7127

RIN: 0991-AB21
_______________________________________________________________________




915. 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's 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         08/18/87
Second NPRM                     08/13/02                    67 FR 52696
Second NPRM Comment Period End  10/12/02
Final Rule                      11/00/02

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Additional Information: Transferred from RIN 0990-AA02

Agency Contact: Katherine M. Drews, Associate General Counsel, 
Department of Health and Human Services, Office of the Secretary, 
Office of the General Counsel, Room 5362, HHS Cohen Building, 330 
Independence Avenue SW., Washington, DC 20201
Phone: 202 619-0150

Related RIN: Previously reported as 0990-AA02
RIN: 0991-AB22

[[Page 74504]]

_______________________________________________________________________


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


Office of the Secretary (OS)



_______________________________________________________________________




916. REVISIONS TO 42 CFR PART 1003

Priority: Substantive, Nonsignificant

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

CFR Citation: 42 CFR 1003

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                             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
_______________________________________________________________________




917. 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: The proposed final rule would 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 
Supplemental Health Insurance policies (Medigap) for financially needy 
Medicare beneficiaries with end-stage renal disease (ESRD). The safe 
harbor would specifically establish 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

________________________________________________________________________

Final Rule                       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-AB04
_______________________________________________________________________




918. 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                            12/06/00                    65 FR 76460


Next Action Undetermined

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected: Businesses, Governmental Jurisdictions, 
Organizations

Government Levels Affected: State, Local, Federal, Tribal

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

RIN: 0991-AB10
_______________________________________________________________________




919. 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                            01/23/02                     67 FR 3315
NPRM Comment Period End         03/25/02


Next Action Undetermined

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Diane Osterhus, Federal Assistance Policy Specialist,

[[Page 74505]]

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
_______________________________________________________________________


Department of Health and Human Services (HHS)         Completed Actions


Office of the Secretary (OS)



_______________________________________________________________________




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

Priority: Other Significant. Major under 5 USC 801.

CFR Citation: 45 CFR 160; 45 CFR 164

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Rule                      08/14/02                    67 FR 53182

Regulatory Flexibility Analysis Required: Yes

Government Levels Affected: Federal, State, Local, Tribal

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

Agency Contact: Susan McAndrew
Phone: 202 205-8725

RIN: 0991-AB14
_______________________________________________________________________




921. IMPLEMENTING THE BIOTERRORISM PREVENTION AND RESPONSE ACT OF 2001

Priority: Other Significant

CFR Citation: None

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn                       09/06/02

Regulatory Flexibility Analysis Required: No

Government Levels Affected: State, Tribal, Federal

Agency Contact: Alex Azar
Phone: 202 690-7741

RIN: 0991-AB15

_______________________________________________________________________


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


Substance Abuse and Mental Health Services Administration (SAMHSA)



_______________________________________________________________________




922. SECLUSION AND RESTRAINT FOR NON-MEDICAL RESIDENTIAL FACILITIES

Priority: Substantive, Nonsignificant

Legal Authority: PL 106-310

CFR Citation: Not Yet Determined

Legal Deadline: NPRM, Statutory, April 2001.

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

Timetable: Next Action Undetermined

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: 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

_______________________________________________________________________


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


Centers for Disease Control and Prevention (CDC)



_______________________________________________________________________




923. CONTROL OF COMMUNICABLE DISEASES

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

RIN: 0920-AA03
_______________________________________________________________________




924. 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

[[Page 74506]]

restructured fee schedule; and 5) fee retention in the respirator 
program.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/00/02

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Roland Berry Ann, Acting Chief, Respirator Branch, 
National Personal Protection Technology Laboratory, Department of 
Health and Human Services, Centers for Disease Control and Prevention, 
NIOSH, P.O. Box 18070, 626 Cochrans Mill Road, Pittsburgh, PA 15236
Phone: 412 386-4000

RIN: 0920-AA04
_______________________________________________________________________


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


Centers for Disease Control and Prevention (CDC)



_______________________________________________________________________




925. PROCEDURES FOR DESIGNATING CLASSES OF EMPLOYEES AS MEMBERS OF THE 
SPECIAL EXPOSURE COHORT UNDER THE ENERGY EMPLOYEE OCCUPATIONAL ILLNESS 
COMPENSATION ACT OF 2000

Priority: Substantive, Nonsignificant

Legal Authority: 42 USC 7384g; EO 13179

CFR Citation: 42 CFR Par 83

Legal Deadline: None

Abstract: Pursuant to the Energy Employees Occupational Illness 
Compensation Program Act, HHS plans to finalize procedures to petition 
the Secretary to be added to the Special Exposure Cohort.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/25/02                    67 FR 42962
Final Rule                      01/00/03

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Larry Elliott, Director, Office of Compensation 
Analysis and Support, Department of Health and Human Services, Centers 
for Disease Control and Prevention, NIOSH, R44, 5555 Ridge Avenue, 
Cincinnati, OH 45213
Phone: 513 841-4498

RIN: 0920-AA07
_______________________________________________________________________




926. [bull] POSSESSION, USE, AND TRANSFER OF SELECT AGENTS

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

RIN: 0920-AA08
_______________________________________________________________________


Department of Health and Human Services (HHS)         Completed Actions


Centers for Disease Control and Prevention (CDC)



_______________________________________________________________________




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

Priority: Other Significant

CFR Citation: 42 CFR 81; 42 CFR 82

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Rule                      05/02/02                    67 FR 22296

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Larry Elliott
Phone: 513 841-4498

RIN: 0920-AA05

_______________________________________________________________________


Department of Health and Human Services (HHS)         Completed Actions


Departmental Management (HHSDM)



_______________________________________________________________________




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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Transferred to RIN 0991-AB22    10/01/02

RIN: 0990-AA02
_______________________________________________________________________




929. ADMINISTRATIVE WAGE GARNISHMENT

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Transferred to RIN 0991-AB20    08/23/02

RIN: 0990-AA05


[[Page 74507]]

_______________________________________________________________________


Department of Health and Human Services (HHS)             Prerule Stage


Food and Drug Administration (FDA)



_______________________________________________________________________




930. 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                           11/00/02

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
_______________________________________________________________________


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


Food and Drug Administration (FDA)



_______________________________________________________________________




931. ESTABLISHMENT REGISTRATION AND LISTING FOR DRUGS AND BIOLOGICS

Priority: Other Significant

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

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

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                            05/00/03

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-AA49
_______________________________________________________________________




932. SAFETY REPORTING REQUIREMENTS FOR HUMAN DRUG AND BIOLOGICAL 
PRODUCTS

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

RIN: 0910-AA97
_______________________________________________________________________




933. 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 630; 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 end users of 
plasma-derivative products of product safety information; and 3) 
requirements for donor suitability and testing. 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); Revision of Requirements  Direct Final Rule 05/14/99 (64 FR 
26282)  NPRM 05/14/99 (64 FR 26344)  Direct Final Rule - Confirmation 
in Part and Technical Amendment 03/14/00 (65 FR 13678)  Final Action 
08/28/00 (65 FR 52016)

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

[[Page 74508]]

Regulations for Human Blood and Blood Components Intended for 
Transfusion or For Further Manufacturing Use  NPRM 09/00/03

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

Revisions to Labeling and Storage Requirements for Blood and Blood 
Components, Including Source Plasma  NPRM 05/00/03

Revisions 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)  Direct Final Rule - Confirmation in Part and 
Technical Amendment 01/10/01 (66 FR 1834)  Final Action 08/06/01 (66 FR 
40886)

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Paula S. McKeever, Regulatory Policy Analyst, 
Department of Health and Human Services, Food and Drug Administration, 
Suite 200N (HFM-17), Center for Biologics Evaluation and Research, 1401 
Rockville Pike, Rockville, MD 20852-1448
Phone: 301 827-6210
Fax: 301 594-1944

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




934. 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 to 353; 21 USC 355; 
21 USC 371; 21 USC 374; 21 USC 379e

CFR Citation: 21 CFR 312; 21 CFR 314

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/00/03

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
_______________________________________________________________________




935. 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                            03/00/03

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
_______________________________________________________________________




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

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

RIN: 0910-AB88
_______________________________________________________________________




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

Priority: Routine and Frequent

Legal Authority: 21 USC 331 to 334; 21 USC 335b; 21 USC 335c; 21 USC 
341 to 344; 21 USC 348; 21 USC 351; 21 USC 352; 21 USC 355; 21 USC 360; 
21 USC 360c-360f; 21 USC 361; 21 USC 362; 21 USC 371; 21 USC 372; 21 
USC 374; 21 USC 376; 21 USC 381; 21 USC 393; 42 USC 262; 42 USC 264

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 
would include recordkeeping requirements to ensure 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.

[[Page 74509]]

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            03/00/03

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
_______________________________________________________________________




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

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

RIN: 0910-AC14
_______________________________________________________________________




939. INSTITUTIONAL REVIEW BOARDS: REGISTRATION REQUIREMENTS

Priority: Info./Admin./Other

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

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 IRB, the name of the institution operating the IRB, and 
names, addresses, phone numbers, facsimile (fax) numbers, and 
electronic mail (e-mail) addresses of the senior officer of the 
institution and IRB chair or contact, the range of active protocols 
(small, medium, or large) involving FDA-regulated products reviewed in 
the previous calendar year, and a description of the types of FDA-
regulated products reviewed. The proposed rule would make it easier for 
FDA to inspect IRBs and to convey information to IRBs.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            02/00/03

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
_______________________________________________________________________




940. 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 The disease has been identified in wild and 
farmed elk and wild deer populations.
CWD is endemic in cervid populations in certain areas of Wisconsin, 
Colorado, Nebraska, Wyoming, Kansas, Montana, Oklahoma, South Dakota, 
New Mexico, Minnesota, and Canada. The disease has been identified in 
wild and farmed elk and wild deer populations. In 1999, the World 
Health Organization (WHO) said there is no evidence that CWD transmits 
to humans. However, it also suggested any part of a deer or elk 
believed to be diseased should not be eaten. Scientific studies in the 
literature suggest that transmission to humans could possibly occur. 
However, if it does occur, it is likely to be through a very 
inefficient process.
Currently, there are no validated analytical tests to identify animals 
in the pre-clinical phase of CWD, or any other TSE. In addition, no 
test exists to ensure food safety. CWD typically exhibits a long 
incubation period, during which time animals appear normal but are 
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                            09/00/03

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: Undetermined

Federalism:  Undetermined

Agency Contact: Rebecca Buckner, Consumer Safety Officer, Department of 
Health and Human Services, Food and Drug Administration, HFS-306, 
Center for Food Safety and Applied Nutrition, 5100 Paint Branch 
Parkway, College Park, MD 20740
Phone: 301 436-1486
Fax: 301 436-2632
Email: [email protected]

RIN: 0910-AC21
_______________________________________________________________________




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

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

RIN: 0910-AC25
_______________________________________________________________________




942. BAR CODE LABEL REQUIREMENTS FOR HUMAN DRUG PRODUCTS

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

RIN: 0910-AC26

[[Page 74510]]

_______________________________________________________________________




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

Priority: Substantive, Nonsignificant

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

CFR Citation: 21 CFR 800.20

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/00/02

Regulatory Flexibility Analysis Required: No

Government Levels Affected: Undetermined

Federalism:  Undetermined

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
Fax: 301 594-4795
Email: [email protected]

RIN: 0910-AC32
_______________________________________________________________________




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

Priority: Substantive, Nonsignificant

Legal Authority: 21 USC 301 et seq; 21 USC 360kk et seq

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

Legal Deadline: None

Abstract: This rule amends the performance standard for diagnostic x-
ray systems and their components in 21 CFR 1020.30, 1020.31, and 
1020.32 to address the changes in technology and practice and to fully 
utilize the currently accepted metric system.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            07/00/03

Regulatory Flexibility Analysis Required: No

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
Fax: 301 594-4795
Email: [email protected]

RIN: 0910-AC34
_______________________________________________________________________




945. [bull] ADMINISTRATIVE DETENTION

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

RIN: 0910-AC38
_______________________________________________________________________




946. [bull] ESTABLISHMENT AND MAINTENANCE OF RECORDS TO IDENTIFY 
IMMEDIATE PREVIOUS SOURCE AND IMMEDIATE SUBSEQUENT RECIPIENT OF FOODS

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

RIN: 0910-AC39
_______________________________________________________________________




947. [bull] REGISTRATION OF FOOD AND ANIMAL FEED FACILITIES

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

RIN: 0910-AC40
_______________________________________________________________________




948. [bull] ESTABLISHMENT OF PRIOR NOTIFICATION REQUIREMENT FOR ALL 
IMPORTED FOOD SHIPMENTS

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

RIN: 0910-AC41
_______________________________________________________________________




949. 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 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                            03/00/03

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

[[Page 74511]]

Fax: 301 594-4512

Related RIN: Previously reported as 0910-AB50
RIN: 0910-AC43
_______________________________________________________________________




950. [bull] APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG: PATENT 
LISTING REQUIREMENTS AND APPLICATION OF 30-MONTH STAYS ON APPROVAL OF 
ABBREVIATED NEW DRUG APPLICATIONS

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

RIN: 0910-AC48
_______________________________________________________________________


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


Food and Drug Administration (FDA)



_______________________________________________________________________




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

Priority: Routine and Frequent

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

CFR Citation: 21 CFR 310; 21 CFR 340 to 345; 21 CFR 330; 21 CFR 333 to 
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.
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:
________________________________________________________________________

Antidiarrheal Products  NPRM (Amendment)(Trav. Diar.) 04/00/03  Final 
Action 04/00/03

Antiemetic Products  Final Action (Amendment) (Warning) 12/00/02

Antiperspirant Products  Final Action 04/00/03

Cough/Cold (Antihistamine) Products  Final Action (Amendment)(Warning) 
12/00/02

Cough/Cold (Antitussive) Products  Final Action (Amendment)(Warning) 
12/00/02

Cough/Cold (Combination) Products  Final Action 04/00/03

Cough/Cold (Nasal Decongestant) Products  NPRM (Phenylpropanolamine) 
04/00/03

External Analgesic Products  Final Action (Amendment)(Warning) 12/00/02

Ingrown Toenail Relief Products  NPRM 10/04/02 (67 FR 62218)

Internal Analgesic Products  NPRM (Amendment)(Ibuprofen) 08/12/02 (67 
FR 54139)  NPRM (Amendment) (Pediatric) 04/00/03

Labeling of Drug Products for OTC Human Use  NPRM (Convenience Sizes) 
03/00/03  Final Action (Ca/Mg/K/Na) 06/00/03  Final Action (Sodium 
Labeling) 06/00/03  NPRM (Sodium Labeling) 06/00/03

Laxative Drug Products  NPRM (Amendment) (Psyllium Granular Dosage 
Form) 10/00/03

Nighttime Sleep Aid Products  Final Action (Amendment)(Warning) 12/00/
02

Ophthalmic Products  NPRM (Emergency First Aid Eyewashes) 01/00/
03  Final Action (Technical Amendment) 01/00/03

Oral Health Care Products  ANPRM (Plaque/Gingivitis) 04/00/03

Pediculicide Products  NPRM (Labeling Amendment) 05/10/02 (67 FR 31739)

Salicylate (Reye Syndrome)  Final Action (Warning) 04/00/03

Skin Protectant Products  Final Action 04/00/03  Final Action 
(Astringent) 06/00/03  NPRM (Astringent) 06/00/03

Status of Certain Category II and III Ingredients  Final Action 05/09/
02 (67 FR 31123)  Final Action 05/09/02 (67 FR 31125)

Sunscreen Products  Final Action (Names) 06/20/02 (67 FR 41821)  ANPRM 
(and Insect Repellent) 02/00/03  NPRM (UVA/UVB) 08/00/03

Vaginal Contraceptive Products  NPRM (Amendment) 03/00/03

Weight Control Products  NPRM (Phenylpropanolamine) 04/00/03

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
_______________________________________________________________________




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

Priority: Routine and Frequent

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

CFR Citation: 21 CFR 312.110

Legal Deadline: None

Abstract: The 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,

[[Page 74512]]

without prior Food and Drug Administration (FDA) approval and without 
an IND, if the product is to be exported for use in a clinical 
investigation and has received marketing authorization in certain 
developed countries. The third route would permit exportation, without 
prior FDA approval and without an IND, if the product is to be exported 
for use in a clinical investigation in certain specified developed 
countries. The fourth route would permit exportation without an IND, to 
any country provided that the exporter sends a written certification to 
FDA at the time the drug is first exported. Drugs exported under any of 
the first three routes would, however, be subject to certain statutory 
requirements, such as not conflicting with the foreign country's laws 
and not being sold or offered for sale in the United States. Drugs 
exported under either the second or third routes would be subject to 
additional statutory requirements, such as being in substantial 
conformity with the current good manufacturing practices and certain 
labeling requirements. These provisions would implement changes in 
FDA's export authority resulting from the FDA Export Reform and 
Enhancement Act of 1996.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/19/02                    67 FR 41642
Final Action                    05/00/03

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
_______________________________________________________________________




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

Priority: Other Significant

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

CFR Citation: 21 CFR 50; 21 CFR 312

Legal Deadline: None

Abstract: The final rule would establish 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 Federal law, 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, contrary to the 
best interests of recipients, or contrary to national security 
interests.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              10/05/99                    64 FR 54180
Final Action                    03/00/03

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
_______________________________________________________________________




954. LABELING FOR HUMAN PRESCRIPTION DRUGS; REVISED FORMAT

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

RIN: 0910-AA94
_______________________________________________________________________




955. REVISIONS TO THE GENERAL SAFETY REQUIREMENTS FOR BIOLOGICAL 
PRODUCTS; 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                    03/00/03

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

[[Page 74513]]

_______________________________________________________________________




956. 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                    09/00/03

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
_______________________________________________________________________




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

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

RIN: 0910-AB66
_______________________________________________________________________




958. 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. 43 in part II of this issue of 
the Federal Register.

RIN: 0910-AB76
_______________________________________________________________________




959. ANTIBIOTIC RESISTANCE LABELING

Priority: Other Significant

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

CFR Citation: 21 CFR 201.24

Legal Deadline: None

Abstract: The final rule would require the inclusion of certain 
statements about the use of antibiotics in the prescription drug 
labeling of these products. These statements will emphasize the proper 
use of these products in an effort to reduce the development of drug-
resistant bacterial strains.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/19/00                    65 FR 56511
Final Rule                      03/00/03

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

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

RIN: 0910-AB78
_______________________________________________________________________




960. REQUIREMENTS FOR SUBMISSION OF LABELING FOR HUMAN PRESCRIPTION 
DRUGS AND BIOLOGICS IN ELECTRONIC FORMAT

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 353; 21 USC 
355; 21 USC 360; 21 USC 371; 21 USC 374; 21 USC 379e; ...

CFR Citation: 21 CFR 314; 21 CFR 601

Legal Deadline: None

Abstract: The Food and Drug Administration (FDA) 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 rule would require that certain labeing 
content described under section 201.160(d)(3) be submitted to FDA in 
electronic format.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            05/03/02                    67 FR 22367
Final Action                    09/00/03

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected: No

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-AB91

[[Page 74514]]

_______________________________________________________________________




961. 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 that, within six months of the date of its 
enactment on 10/17/2000, FDA adopt existing HHS regulations providing 
additional protections for children involved as subjects in research. 
FDA published an interim rule in April 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                      06/00/03

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Carol Drew, Regulatory Counsel, 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
_______________________________________________________________________




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

Priority: Other Significant

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

CFR Citation: 21 CFR 201.323(c)

Legal Deadline: None

Abstract: The final rule will revise 21 CFR 323(c) to permit small-
volume parenterals and pharmacy bulk packages that contain no more than 
25 ug/L of aluminum to state ``contains no more than 25ug/L'' rather 
than the exact amount of aluminum.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            08/12/02                    67 FR 52429
Final Action                    03/00/03

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected: No

Government Levels Affected: None

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

RIN: 0910-AC18
_______________________________________________________________________




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

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

RIN: 0910-AC35
_______________________________________________________________________




964. [bull] RECORDS AND REPORTS CONCERNING EXPERIENCE WITH APPROVED NEW 
ANIMAL DRUGS

Priority: Other Significant

Legal Authority: 21 USC 360b(l)

CFR Citation: 21 CFR 514.80

Legal Deadline: None

Abstract: In the Federal Register of December 17, 1991 (56 FR 65581), 
FDA published a proposed rule to revise Section 510.300 (21 CFR 
510.300) and to redesignate it a Section 514.80 (21 CFR 514.80). This 
regulation implements section 512(l) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360b(l), which provides that, following 
approval of a new animal drug application or an abbreviated new animal 
drug application, applicants must establish and maintain records and 
make reports to the agency as prescribed by regulation or order. FDA 
proposed the revision to define more clearly the kinds of information 
to be maintained and submitted by the applicant and to revise the 
timing and content of certain reports to enhance the usefulness of the 
information.
After considering comments submitted in response to the proposed rule 
for records and reports, FDA adopted the rule in modified form. 
Therefore, FDA issued an interim final rule on February 4, 2002 (67 FR 
5046), which differed in some respects from the proposed rule. For 
instance, the interim final rule did not address medicated feed 
applications because they were eliminated by the Animal Drug 
Availability Act of 1996. Also, while the proposed rule for records and 
reports proposed to remove 21 CFR 510.310, which addressed records and 
reports for new animal drugs approved before June 20, 1963, FDA issued 
a final rule that revoked this provision in response to the 
Administration's ``Reinventing Government Initiative'' (61 FR 37680, 
July 19, 1996). The proposed rule for records and reports followed a 
style and format similar to the human drug records and reports 
regulations in part 314 (21 CFR part 314). The interim final rule 
maintained a similar style and format, but removed many of the proposed 
records and reports requirements that are not necessary to monitor 
animal drugs.
FDA received 33 comments to the interim final rule. In response to 
those comments, the agency further streamlined and clarified the 
regulation. FDA is affirming the interim final rule on its requirements 
for records and reports concerning experiences with approved new animal 
drugs (67 FR 5046) with modifications. The modifications include: 
revising the definitions of ``applicant'' and ``serious adverse drug 
experience;'' modifying the reporting requirement for summary reports 
of increased frequency of adverse drug experiences; clarifying what 
safety and efficacy records a nonapplicant versus an applicant must 
maintain; changing one word in the title of the section of the 
regulation pertaining to nonclinical laboratory studies and clinical 
data; eliminating the requirement of submission of prepublication 
manuscripts relating to completed clinical trials; changing

[[Page 74515]]

distributor's labeling so that the qualifying phrase that must precede 
the name and address of the distributor is as permitted by 21 CFR 
201.1; and revising the section of the rule pertaining to distributor's 
signed statements to state that the distributor will promote the 
product only for use under the conditions stated in the approved 
labeling.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/17/91                    56 FR 65581
NPRM Comment Period End         02/18/92
Interim Final Rule              02/04/02                     67 FR 5046
Interim Final Rule Comment 
Period End                      04/05/02
Interim Final Rule Effective 
Date Delayed                    07/31/02                    67 FR 49568
Final Action                    01/00/03

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Glenn Peterson, Mathematician/Statistician 
(Biomedical), Department of Health and Human Services, Food and Drug 
Administration, HFV-212, Center for Veterinary Medicine, 7500 Standish 
Place, Rockville, MD 20855
Phone: 301 827-0224
Fax: 301 827-1485
Email: [email protected]

Related RIN: Previously reported as 0910-AA02
RIN: 0910-AC42
_______________________________________________________________________




965. 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 Action                    06/00/03

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: 301 827-0205

Related RIN: Previously reported as 0910-AB68
RIN: 0910-AC44
_______________________________________________________________________




966. 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 amending 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 the 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 changes revise the definition of ``no residue'' to mean that no 
residue is detected with an approved regulatory method. The rule has 
several conditions that sponsors of carcinogenic compounds must satisfy 
with respect to the sponsors' proposed regulatory methods.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            01/17/02                     67 FR 2384
NPRM Comment Period Ends        04/17/02
Final Action                    01/00/03

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]

Related RIN: Previously reported as 0910-AC13
RIN: 0910-AC45
_______________________________________________________________________




967. 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
NPRM Comment Period End         02/02/99
Final Rule                      05/00/03

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

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

Related RIN: Previously reported as 0910-AA51
RIN: 0910-AC47

[[Page 74516]]

_______________________________________________________________________


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


Food and Drug Administration (FDA)



_______________________________________________________________________




968. 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 12/00/03

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 12/00/03

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Shellee Anderson, Food Technologist, Department of 
Health and Human Services, Food and Drug Administration, HFS-800, 
Center for Food Safety and Applied Nutrition, 5100 Paint Branch 
Parkway, College Park, MD 20740
Phone: 301 436-1693
Email: [email protected]

RIN: 0910-AA04
_______________________________________________________________________




969. 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 solicit 
and consider 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
End Review                      12/00/03

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
_______________________________________________________________________




970. ELIGIBILITY DETERMINATION FOR DONORS OF HUMAN CELLS, TISSUES, AND 
CELLULAR AND TISSUE-BASED PRODUCTS (HCT/PS)

Priority: Other Significant

Legal Authority: 42 USC 216; 42 USC 243; 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 
211.1(b); 21 CFR 820.1(a)(1); 21 CFR 820.1(c); 21 CFR 1271

Legal Deadline: None

Abstract: The Food and Drug Administration is requiring certain 
manufacturers of human cells, tissues, and cellular and tissue-based 
products to take actions to screen 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 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 End         12/29/99
NPRM Comment Period Reopened    04/18/00                    65 FR 20774
NPRM Comment Period Reopened End07/17/00
Final Action                     To Be                       Determined

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: State

[[Page 74517]]

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
Fax: 301 594-1944

RIN: 0910-AB27
_______________________________________________________________________




971. CURRENT GOOD TISSUE PRACTICE FOR MANUFACTURERS OF HUMAN CELLS, 
TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS (HCT/PS); INSPECTION AND 
ENFORCEMENT

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: The Food and Drug Administration (FDA) is proposing to 
require certain 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, the 
maintenance of a quality program labeling and reporting. FDA is also 
proposing inspection and enforcement provisions.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            01/08/01                     66 FR 1508
NPRM Comment Period End         05/08/01
Final Action                     To Be                       Determined

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
Fax: 301 594-1944

RIN: 0910-AB28
_______________________________________________________________________




972. 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 Rule                       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, 5100 Paint Branch 
Parkway, College Park, MD 20740
Phone: 202 418-3101
Fax: 202 418-3131
Email: [email protected]

RIN: 0910-AC15
_______________________________________________________________________




973. USE OF MATERIALS DERIVED FROM BOVINE AND OVINE 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

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 bovine and ovine 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                            12/00/03

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Federalism:  Undetermined

Agency Contact: Rebecca Buckner, Consumer Safety Officer, Department of 
Health and Human Services, Food and Drug Administration, HFS-306, 
Center for Food Safety and Applied Nutrition, 5100 Paint Branch 
Parkway, College Park, MD 20740
Phone: 301 436-1486
Fax: 301 436-2632
Email: [email protected]

RIN: 0910-AC19
_______________________________________________________________________




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

Priority: Substantive, Nonsignificant

Legal Authority: 21 USC 351; 21 USC 360c(e)(1); 21 USC 371

CFR Citation: 21 CFR 868.2700; 21 CFR 868.5905

Legal Deadline: None

Abstract: The Food and Drug Administration is proposing to

[[Page 74518]]

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/00/03

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Federalism:  Undetermined

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
Fax: 301 594-4795
Email: [email protected]

RIN: 0910-AC30
_______________________________________________________________________


Department of Health and Human Services (HHS)         Completed Actions


Food and Drug Administration (FDA)



_______________________________________________________________________




975. USE OF OZONE-DEPLETING SUBSTANCES

Priority: Other Significant

CFR Citation: 21 CFR 2

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    07/24/02                    67 FR 48370

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Wayne H. Mitchell
Phone: 301 594-2041
Fax: 301 827-5562
Email: [email protected]

RIN: 0910-AA99
_______________________________________________________________________




976. FOOD ADDITIVES: FOOD CONTACT SUBSTANCES NOTIFICATION SYSTEM

Priority: Substantive, Nonsignificant

CFR Citation: 21 CFR 20.100; 21 CFR 58.3; 21 CFR 170.3; 21 CFR 170.100 
to 170.105; 21 CFR 171.1; 21 CFR 171.4; 21 CFR 174.5; 21 CFR 179.25; 21 
CFR 170.106; ...

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Rule                      05/21/02                    67 FR 35724

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Mitchell Alan Cheeseman
Phone: 301 436-1589
Email: [email protected]

RIN: 0910-AB94
_______________________________________________________________________




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

Priority: Other Significant

CFR Citation: 21 CFR 314; 21 CFR 601

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    05/31/02                    67 FR 37988

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Wayne H. Mitchell
Phone: 301 594-2041
Fax: 301 827-5562
Email: [email protected]

RIN: 0910-AC05
_______________________________________________________________________




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

Priority: Substantive, Nonsignificant

CFR Citation: 21 CFR 310.500

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Rule                      06/26/02                    67 FR 42992

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Mary E. Catchings
Phone: 301 594-2041
Fax: 301 827-0951

RIN: 0910-AC12
_______________________________________________________________________




979. POSTMARKET SURVEILLANCE

Priority: Substantive, Nonsignificant

CFR Citation: 21 CFR 822

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    06/06/02                    67 FR 38878

Regulatory Flexibility Analysis Required: Yes

Government Levels Affected: None

Agency Contact: Joseph M. Sheehan
Phone: 301 827-2974
Fax: 301 594-4795
Email: [email protected]

RIN: 0910-AC31

[[Page 74519]]

_______________________________________________________________________


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


Health Resources and Services Administration (HRSA)



_______________________________________________________________________




980. 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                     11/00/02

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
_______________________________________________________________________




981. 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                     11/00/02

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Andy Jordan, Acting Chief, Shortage Designation Branch, 
Department of Health and Human Services, Health Resources and Services 
Administration, National Center for Health Workforce Analysis, Bureau 
of Health Professions, 4350 East-West Highway, Bethesda, MD 20814
Phone: 301 594-0816
Email: [email protected]

RIN: 0906-AA44
_______________________________________________________________________




982. 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                            11/00/02

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

[[Page 74520]]

_______________________________________________________________________


Department of Health and Human Services (HHS)         Completed Actions


Health Resources and Services Administration (HRSA)



_______________________________________________________________________




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

Priority: Substantive, Nonsignificant

CFR Citation: 42 CFR 100

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Rule                      07/25/02                    67 FR 48558

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Marian Jordan
Phone: 301 443-4998
Fax: 301 443-8196
Email: [email protected]

Related RIN: Duplicate of 0906-AA58
RIN: 0906-AA55

_______________________________________________________________________


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


Indian Health Service (IHS)



_______________________________________________________________________




984. 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                    11/00/02

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
_______________________________________________________________________


Department of Health and Human Services (HHS)         Completed Actions


Indian Health Service (IHS)



_______________________________________________________________________




985. TRIBAL SELF-GOVERNANCE AMENDMENTS

Priority: Other Significant

CFR Citation: None

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Rule                      05/17/02                    67 FR 35333

Regulatory Flexibility Analysis Required: No

Government Levels Affected: Federal, Tribal

Agency Contact: Paula K. Williams
Phone: 301 443-7821

RIN: 0917-AA05

_______________________________________________________________________


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


National Institutes of Health (NIH)



_______________________________________________________________________




986. UNDERGRADUATE SCHOLARSHIP PROGRAM REGARDING PROFESSIONS NEEDED BY 
THE NATIONAL INSTITUTES OF HEALTH (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                            11/00/02

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Jerry Moore, NIH Regulations Officer, Department of

[[Page 74521]]

 Health and Human Services, National Institutes of Health, Room 601 MSC 
7669, 6011 Executive Boulevard, Rockville, MD 20852
Phone: 301 496-4606
Fax: 301 402-0169
Email: [email protected]

RIN: 0925-AA10
_______________________________________________________________________




987. NATIONAL INSTITUTES OF HEALTH (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, 445I, 452E, and 
485F of the Public Health Service Act (PHS Act). Section 409C concerns 
centers of excellence regarding research on autism; section 445I 
concerns centers of excellence in Alzheimer's disease research and 
treatment; section 452E concerns centers regarding research on 
``fragile X;'' and section 485F concerns centers of excellence for 
research education and training for individuals who are members of 
minority health disparity populations.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/00/02

Regulatory Flexibility Analysis Required: No

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
Fax: 301 402-0169
Email: [email protected]

RIN: 0925-AA24
_______________________________________________________________________




988. NATIONAL INSTITUTES OF HEALTH (NIH) TRAINING GRANTS

Priority: Substantive, Nonsignificant

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

CFR Citation: 42 CFR 63a

Legal Deadline: None

Abstract: NIH proposes to amend the training grants regulations to 
implement the new authority under section 452G of the 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 
(NICHHD) 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 
supporting pediatric training.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            03/00/03

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Jerry Moore, NIH Regulations Officer, Department of 
Health and Human Services, National Institutes of Health, Room 601 MSC 
7669, 6011 Executive Boulevard, Rockville, MD 20852
Phone: 301 496-4606
Fax: 301 402-0169
Email: [email protected]

RIN: 0925-AA28
_______________________________________________________________________




989. [bull] NATIONAL INSTITUTES OF HEALTH (NIH) AIDS RESEARCH LOAN 
REPAYMENT PROGRAM

Priority: Substantive, Nonsignificant

Unfunded Mandates: Undetermined

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 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. NIH is issuing regulations that will 
govern the program.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            03/00/03

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Jerry Moore, NIH Regulations Officer, Department of 
Health and Human Services, National Institutes of Health, Room 601 MSC 
7669, 6011 Executive Boulevard, Rockville, MD 20852
Phone: 301 496-4606
Fax: 301 402-0169
Email: [email protected]

RIN: 0925-AA32
_______________________________________________________________________


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


National Institutes of Health (NIH)



_______________________________________________________________________




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

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                            08/05/02                    67 FR 50622
Final Rule                      12/00/02

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
Fax: 301 402-0169
Email: [email protected]

RIN: 0925-AA18

[[Page 74522]]

_______________________________________________________________________




991. 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                    03/00/03

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
Fax: 301 402-0169
Email: [email protected]

RIN: 0925-AA20
_______________________________________________________________________


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


National Institutes of Health (NIH)



_______________________________________________________________________




992. STANDARDS FOR A NATIONAL CHIMPANZEE SANCTUARY SYSTEM

Priority: Substantive, Nonsignificant

Legal Authority: 42 USC 287a-3a

CFR Citation: 42 CFR 52b

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: Next Action Undetermined

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Jerry Moore, NIH Regulations Officer, Department of 
Health and Human Services, National Institutes of Health, Room 601 MSC 
7669, 6011 Executive Boulevard, Rockville, MD 20852
Phone: 301 496-4606
Fax: 301 402-0169
Email: [email protected]

RIN: 0925-AA31

_______________________________________________________________________


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


Office of Public Health and Science (OPHS)



_______________________________________________________________________




993. 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                            11/00/02
NPRM Comment Period End         02/00/03

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

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

Chris Pascal, Director, Office of Research Integrity, Department of 
Health and Human Services, Office of Public Health and Science, Public 
Health and Science, Suite 700, 5515 Security Lane, Rockville, MD 20852
Phone: 301 443-3400

Related RIN: Related To 0940-AA01
RIN: 0940-AA04

[[Page 74523]]

_______________________________________________________________________




994. [bull] HUMAN SUBJECTS PROTECTION REGULATIONS: INSTITUTIONAL REVIEW 
BOARDS REGISTRATION REQUIREMENTS

Priority: Substantive, Nonsignificant

Legal Authority: 5 USC 301; 42 USC 289

CFR Citation: 45 CFR 46

Legal Deadline: None

Abstract: This notice of proposed rulemaking proposes to add subpart F 
to Department of Health and Human Services (HHS) regulations for 
protection of human subjects, 45 CFR part 46, to reqire registration of 
institutional review boards (IRBs) with the Department of Health and 
Human Services (HHS). The registration information would include 
contact information, approximate numbers of active protocols involving 
research conducted or supported by HHS and other Federal agencies, 
accreditation status, IRB membership, and staffing for the IRB. The 
proposed registration requirements will make it easier for Office for 
Human Research Protections (OHRP) to convey information to IRBs and 
will support the current IRB registration operated by OHRP. Under the 
current OHRP IRB registration system, the submission of certain 
registration information is required by human subjects protection 
regulations, and certain other information may be submitted 
voluntarily. This proposed information collection was submitted to te 
Office of Management and Budget under the Paperwork Reduction Act. 
Under the proposed rule, all registration information will be required, 
making the IRB registration system uniform with IRB registration 
requirements of the Food and Drug Administration (FDA), and creating a 
single, HHS IRB Registration system. FDA will simultaneously publish a 
proposed rule regarding FDA IRB registration requirements.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/00/02
NPRM Comment Period End         03/00/03

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: George Gasparis, Department of Health and Human 
Services, Office of Public Health and Science, Office for Human 
Research Protections, The Tower Building, Suite 200, 1101 Wootton 
Parkway, Rockville, MD 20852
Phone: 301 496-7005

RIN: 0940-AA06
_______________________________________________________________________


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


Office of Public Health and Science (OPHS)



_______________________________________________________________________




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

Priority: Substantive, Nonsignificant

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

CFR Citation: 42 CFR 94

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            11/28/00                    65 FR 70830
NPRM Comment Period End         01/29/01
Final Action                    12/00/02

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

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

Chris Pascal, Director, Office of Research Integrity, Department of 
Health and Human Services, Office of Public Health and Science, Public 
Health and Science, Suite 700, 5515 Security Lane, Rockville, MD 20852
Phone: 301 443-3400

Related RIN: Related To 0940-AA04
RIN: 0940-AA01


[[Page 74524]]

_______________________________________________________________________


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


Centers for Medicare & Medicaid Services (CMS)



_______________________________________________________________________




996. END STAGE RENAL DISEASE (ESRD) CONDITIONS FOR COVERAGE (CMS-3818-P) 
(SECTION 610 REVIEW)

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

RIN: 0938-AG82
_______________________________________________________________________




997. 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: This proposed rule would establish conditions of 
participation for Medicare-covered transplants.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Proposed Rule                   07/00/03

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
_______________________________________________________________________




998. 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 proposed rule would revise existing conditions of 
participation that hospices must meet to participate in the Medicare 
program. The proposed requirements focus on the actual care delivered 
to patients and patients' families by hospices and the results of that 
care, reflect an interdisciplinary view of patient care, allow hospices 
greater flexibility in meeting quality standards, and eliminate 
unnecessary procedural requirements.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Proposed Rule                   07/00/03

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
_______________________________________________________________________




999. 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 proposed rule is needed as part of the Administration's 
anti-fraud and abuse efforts. It would give us the authority to enroll 
and re-enroll providers with time frames for re-enrollment.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Proposed Rule                   01/00/03

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
_______________________________________________________________________




1000. NATIONAL STANDARD FOR IDENTIFIERS OF HEALTH PLANS (CMS-6017-P)

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

RIN: 0938-AH87
_______________________________________________________________________




1001. 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 proposed 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. 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. This requirement would 
implement section 13623, OBRA of 1993.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Proposed Rule                   02/00/03

Regulatory Flexibility Analysis Required: Yes

[[Page 74525]]

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
_______________________________________________________________________




1002. MEDICARE HOSPICE CARE AMENDMENTS (CMS-1022-P)

Priority: Substantive, Nonsignificant

Unfunded Mandates: Undetermined

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

CFR Citation: 42 CFR 418

Legal Deadline: None

Abstract: This proposed rule revises certain regulations governing 
coverage and payments for hospice care under the Medicare program as 
required by the Balanced Budged Act of 1997, the Medicare, Medicaid, 
and State Child Health Insurance Program Balanced Budget Refinement Act 
of 1999, and the Medicare, Medicaid, and SCHIP Benefits Improvement and 
Protection Act of 2000.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Proposed Rule                   11/00/02

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: None

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]

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




1003. SUPPLIER STANDARDS FOR HOME OXYGEN, THERAPEUTIC SHOES, HOME 
NUTRITION THERAPY (CMS-6010-P)

Priority: Substantive, Nonsignificant

Legal Authority: Not Yet Determined

CFR Citation: 42 CFR 424.57

Legal Deadline: None

Abstract: This proposed rule would establish service standards for 
suppliers of home oxygen equipment, therapeutic shoes, and home 
infusion therapy.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Proposed Rule                   08/00/03

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Frank Whelan, Health Insurance Specialist, 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
_______________________________________________________________________




1004. ALL PROVIDER BAD DEBT PAYMENT (CMS-1126-P)

Priority: Other Significant

Legal Authority: 42 USC 1302; 42 USC 1395f(b); 42 USC 1395g; 42 USC 
1395.l(a); 42 USC 1395.l(i); 42 USC 1395.l(n); 42 USC 1395x(v); 42 USC 
1395cc; 42 USC 1395hh; 42 USC 1395rr; 42 USC 1395tt

CFR Citation: 42 CFR 413.80; 42 CFR 413.178

Legal Deadline: None

Abstract: This proposed rule would implement a court settlement 
agreement and remove the cap on End Stage Renal Disease (ESRD) bad debt 
reimbursement, which limits payment of allowable bad debts to the 
facility's unrecovered costs. This rule would also reduce the amount of 
reimbursement for bad debt for all providers and suppliers that 
receives reimbursement by 30 percent.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Proposed Rule                   11/00/02

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
_______________________________________________________________________




1005. 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 proposed rule would revise the conditions of 
participation for ICFs/MR. We would set forth these new requirements 
that ICFs/MR must meet to adhere to current trends in the field of 
developmental disabilities. It would address recent developments in 
some facilities in the District of Columbia to further protect the 
health and safety of this vulnerable population.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            03/00/03

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

[[Page 74526]]

_______________________________________________________________________




1006. HEALTH INSURANCE REFORM: CLAIMS ATTACHMENTS STANDARDS (CMS-0050-P)

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

RIN: 0938-AK62
_______________________________________________________________________




1007. 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 proposed rule would increase the rate of reimbursement 
of photocopy expenses as required by the regulations governing 
Utilization and Quality Control Peer Review Organizations. Our current 
regulations identify the photocopying reimbursement methodology for 
prospective payment system hospitals.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Proposed Rule                   11/00/02

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
_______________________________________________________________________




1008. MODIFICATIONS TO MEDICARE MANAGED CARE RULES (CMS-4041-P)

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

Legal Authority: BIPA, sec 605; BIPA, sec 606; BIPA, sec 612; BIPA, sec 
615 to 617; BIPA, sec 620; BIPA, sec 621; BIPA, sec 623

CFR Citation: 42 CFR 409; 42 CFR 417; 42 CFR 422

Legal Deadline: None

Abstract: This proposed rule would implement certain Medicare payment 
provisions of the Medicare, Medicaid, and SCHIP Benefits and 
Improvement Act of 2000. The policy changes include premium reductions 
for M+C enrollees, uniform coverage for M+C plans in multiple 
locations, eliminating health disparities, ESRD enrollees, and 
increased civil money penalties for M+C organizations that terminate 
contracts mid-year. Moreover, this proposed rule describes authority to 
waive or modify requirements that hinder the design of, the offering 
of, or the enrollment in the M+C plans offered to employers or labor 
unions.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            11/00/02

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: Federal

Additional Information: CMS-4041-P was previously identified as CMS-
1180-P.

Agency Contact: Frank Szeflinski, Health Insurance Specialist, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services
Phone: 303 844-7119

RIN: 0938-AK71
_______________________________________________________________________




1009. MEDICARE INPATIENT DISPROPORTIONATE SHARE HOSPITAL (DSH) 
ADJUSTMENT FORMULA (CMS-1171-P)

Priority: Other Significant

Legal Authority: Not Yet Determined

CFR Citation: 42 CFR 412106

Legal Deadline: None

Abstract: This proposed rule clarifies the Medicare DSH adjustment 
calculation in reference to the inclusion of Medicaid patient days. It 
describes the criteria to use in calculating the Medicare DSH 
adjustment for hospitals for purposes of payment under the hospital 
inpatient prospective payment system.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Proposed Rule                   01/00/03

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
_______________________________________________________________________




1010. ELIMINATION OF STATEMENT OF INTENT PROCEDURES FOR FILING MEDICARE 
CLAIMS (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: None

Abstract: This proposed rule would revise the requirements concerning 
the written statement of intent procedures for filing Medicare claims 
from the current Medicare regulation.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Proposed Rule                   04/00/03

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
_______________________________________________________________________




1011. ORGAN PROCUREMENT ORGANIZATION CONDITIONS FOR COVERAGE (CMS-3064-
P)

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

RIN: 0938-AK81

[[Page 74527]]

_______________________________________________________________________




1012. 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

CFR Citation: 42 CFR 406.12

Legal Deadline: None

Abstract: This rule would provide working disabled individuals with 
continued Medicare entitlement for an additional 54 months beyond the 
current limit. It would implement the Ticket to Work and Work 
Incentives Improvement Act of 1999.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Proposed Rule                   03/00/03

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
_______________________________________________________________________




1013. UPDATE INTEREST ASSESSMENT ON MEDICARE OVERPAYMENT AND 
UNDERPAYMENT (CMS-6014-P)

Priority: Other Significant

Legal Authority: Social Security Act, sec 1815(d); Social Security Act, 
sec 1833(j)

CFR Citation: 42 CFR 405.378

Legal Deadline: None

Abstract: This proposed rule would change the formula used to compute 
interest on provider, supplier overpayments and underpayments.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            03/00/03

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected: Businesses, Organizations

Government Levels Affected: None

Agency Contact: Paul Thomas Reed, Financial Management Specialist, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, C3-15-07, 7500 Security Boulevard, Baltimore, MD 
21244
Phone: 410 786-4001
Email: [email protected]

RIN: 0938-AL14
_______________________________________________________________________




1014. USE OF RESTRAINT AND SECLUSION IN MEDICARE AND MEDICAID 
PARTICIPATING FACILITIES THAT PROVIDE INPATIENT OR RESIDENTIAL CARE 
(CMS-2130-P)

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

RIN: 0938-AL26
_______________________________________________________________________




1015. 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

CFR Citation: 42 CFR 414

Legal Deadline: None

Abstract: This rule removes respiratory assist devices with bi-level 
capability and a back-up rate from the category for items requiring 
frequent and substantial servicing, and places them in the category for 
other items, or capped rental items. This rule corrects an error that 
occurred in 1992, where these devices were inappropriately placed in 
the category for items requiring frequent and substantial servicing.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Proposed Rule                   03/00/03

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: None

Federalism:  Undetermined

Agency Contact: Joel Kaiser, Center for Medicare Management, Department 
of Health and Human Services, Centers for Medicare & Medicaid Services, 
7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-4499

RIN: 0938-AL27
_______________________________________________________________________




1016. SELF-DECLARATION OF CITIZENSHIP (CMS-2085-P)

Priority: Info./Admin./Other

Legal Authority: Public Law 104-193, Sec 431

CFR Citation: 42 CFR 435.410; 42 CFR 436.410

Legal Deadline: None

Abstract: This proposed rule would require States, on a post-
determination basis, to carry out a process for verifying citizenship 
in a sample of cases to ensure that program integrity is being 
maintained. This proposed rule would also clearly state that acceptance 
of the individual's self-declaration is an option.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Proposed Rule                   01/00/03

Regulatory Flexibility Analysis Required: No

Government Levels Affected: State

Agency Contact: Sarah DeLone, Health Insurance Specialist, Department 
of Health and Human Services, Centers for Medicare & Medicaid Services, 
S2-01-16, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-7010

RIN: 0938-AL33
_______________________________________________________________________




1017. PERMITTING PREMIUM REDUCTIONS AS ADDITIONAL BENEFITS UNDER 
MEDICARE+CHOICE PLANS (CMS-6016-P)

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

Unfunded Mandates: Undetermined

Legal Authority: Not Yet Determined

CFR Citation: 42 CFR 408.ff

Legal Deadline: Final, Statutory, January 1, 2003.

Abstract: This proposed rule would implement section 606 of BIPA to 
allow M+C organizations to elect a reduction in capitation payments so 
that these

[[Page 74528]]

organizations could offer Medicare part B premium reductions to 
enrollees.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Proposed Rule                   03/00/03

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: State, Local, Federal

Agency Contact: Michele Sanders, Department of Health and Human 
Services, Centers for Medicare & Medicaid Services, 7500 Security 
Boulevard, Baltimore, MD 21244
Phone: 410 786-0808

RIN: 0938-AL49
_______________________________________________________________________




1018. PROSPECTIVE PAYMENT SYSTEM FOR PSYCHIATRIC HOSPITALS (CMS-1213-P)

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

RIN: 0938-AL50
_______________________________________________________________________




1019. PROVIDER REIMBURSEMENT DETERMINATIONS AND APPEALS (CMS-1727-P)

Priority: Substantive, Nonsignificant

Legal Authority: Sec 1878 of the Social Security Act

CFR Citation: Not Yet Determined

Legal Deadline: None

Abstract: This proposed rule would redefine, clarify, and update the 
guidelines and procedures for provider reimbursement review board 
appeals.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Proposed Rule                   05/00/03

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Morton Marcus, Department of Health and Human Services, 
Centers for Medicare & Medicaid Services, C4-26-22, 7500 Security 
Boulevard, Baltimore, MD 21244-1850
Phone: 410 786-4477

RIN: 0938-AL54
_______________________________________________________________________




1020. SCHIP; PURCHASE OF FAMILY COVERAGE--BENEFIT FLEXIBILITY IN PARENT 
COVERAGE (CMS-2148-P)

Priority: Substantive, Nonsignificant

Unfunded Mandates: Undetermined

Legal Authority: 42 USC 2110

CFR Citation: 42 CFR 457

Legal Deadline: None

Abstract: This proposed rule would provide flexibility to States in 
defining their benefit package for adults covered under the State 
Children's Health Insurance Program (SCHIP) family coverage options.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Proposed Rule                   04/00/03

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Terese Klitenic, Center for Medicaid and State 
Operations, Department of Health and Human Services, Centers for 
Medicare & Medicaid Services, C4-25-02, 7500 Security Boulevard, 
Baltimore, MD 21244-1850
Phone: 410 786-5942

RIN: 0938-AL62
_______________________________________________________________________




1021. REQUEST FOR INFORMATION ON BENEFIT-SPECIFIC WAITING PERIODS (CMS-
2150-N)

Priority: Info./Admin./Other

Legal Authority: None

CFR Citation: None

Legal Deadline: None

Abstract: This notice requests information on the use of benefit-
specific waiting periods by group health plan and group health 
insurance issuers.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Notice                          05/00/03

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: David Mlawsky, Health Insurance Specialist, Department 
of Health and Human Services, Centers for Medicare & Medicaid Services, 
S3-16-26, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-6851

RIN: 0938-AL64
_______________________________________________________________________




1022. REVISIONS TO THE MEDICARE APPEALS PROCESS (CMS-4004-P)

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

RIN: 0938-AL67
_______________________________________________________________________




1023. DMERC SERVICE AREAS AND RELATED MATTERS (CMS-1219-P)

Priority: Substantive, Nonsignificant

Legal Authority: Social Security Act, sec 1842; Social Security Act, 
sec 1834(a)(12); Social Security Act, sec 1834(h)(3); Social Security 
Act, sec 1834(j)(1)(E)

CFR Citation: 42 CFR 421.210(c); 42 CFR 421.210(d); 42 CFR 421.210(e)

Legal Deadline: None

Abstract: This proposed rule would allow flexibility in regulatory 
changes to the DMERC contractor structure.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Proposed Rule                   07/00/03

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: James Holt, Health Insurance Specialist, Department of 
Health and Human Services, Centers for Medicare & Medicaid Services, 
S1-14-27, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-1953
Email: [email protected]

RIN: 0938-AL76
_______________________________________________________________________




1024. REVISIONS TO CONDITIONS FOR COVERAGE FOR AMBULATORY SURGICAL 
CENTERS (CMS-3887-P)

Priority: Other Significant. Major under 5 USC 801.

Unfunded Mandates: Undetermined

Legal Authority: Social Security Act, sec 1102; Social Security Act, 
sec 1832; Social Security Act, sec 1871

CFR Citation: 42 CFR 410; 42 CFR 424; 42 CFR 416; 42 CFR 488; 42 CFR 
489

[[Page 74529]]

Legal Deadline: None

Abstract: This proposed rule would revise the ambulatory surgical 
center conditions for coverage to reflect current innovations in 
healthcare delivery, quality assessment, and performance improvement.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Proposed Rule                   06/00/03

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: State

Agency Contact: Joan Brooks, Health Insurance Specialist, Department of 
Health and Human Services, Centers for Medicare & Medicaid Services, 
7500 Security Boulevard, Baltimore, MD 21244-1850
Phone: 410 786-5526

RIN: 0938-AL80
_______________________________________________________________________




1025. MEDICAID COVERAGE RULES FOR INMATES OF PUBLIC INSTITUTIONS (CMS-
2077-P)

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

Unfunded Mandates: Undetermined

Legal Authority: Social Security Act, sec 1905(a)(A)

CFR Citation: 42 CFR 435.1008; 42 CFR 435.1009; 42 CFR 435.1012; 42 CFR 
436.1004

Legal Deadline: None

Abstract: This proposed rule would provide a new interpretation of the 
statute in order to eliminate confusion among the States and to ensure 
consistent application of the FFP exclusionary rules for services 
provided to inmates of a public institution.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Proposed Rule                   07/00/03

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: State, Local

Agency Contact: Tom Shenk, Center for Medicaid and State Operations, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-3295

RIN: 0938-AL85
_______________________________________________________________________




1026. TARGETED CASE MANAGEMENT (CMS-2061-P)

Priority: Substantive, Nonsignificant

Legal Authority: Sec 1915(g) of the Social Security Act

CFR Citation: 42 CFR 431; 42 CFR 440; 42 CFR 441

Legal Deadline: None

Abstract: This proposed rule would amend the Medicaid regulations to 
provide for optional coverage of case management services furnished to 
specific groups, geographic areas, or political subdivisions within a 
State. This proposed rule rescinds the proposed rule that was published 
on 10/15/93.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Proposed Rule                   06/00/03

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Kathy Poisal, Health Insurance Specialist, Department 
of Health and Human Services, Centers for Medicare & Medicaid Services, 
S2-14-26, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-5940

RIN: 0938-AL87
_______________________________________________________________________




1027. HEALTH COVERAGE PORTABILITY: TOLLING CERTAIN TIME PERIODS AND 
INTERACTIONS WITH FAMILY AND MEDICAL LEAVE ACT (CMS-2158-P)

Priority: Other Significant

Legal Authority: 42 USC 300 gg; PL 104-191

CFR Citation: 45 CFR 146.113; 45 CFR 146.115; 45 CFR 146.117; 45 CFR 
146.120; 45 CFR 146.145

Legal Deadline: None

Abstract: This proposed rule would clarify certain portability 
requirements for group health plans and issuers of health insurance 
coverage offered in connection with a group health plan. This rule 
would implement changes made to the Internal Revenue Code, the Employee 
Retirement Income Security Act, and the Public Health Service Act 
enacted as part of the Health Insurance Portability and Accountability 
Act of 1996.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Proposed Rule                   05/00/03

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses, Organizations

Government Levels Affected: State, Local, Federal

Agency Contact: David Mlawsky, Health Insurance Specialist, Department 
of Health and Human Services, Centers for Medicare & Medicaid Services, 
S3-16-26, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-6851

RIN: 0938-AL88
_______________________________________________________________________




1028. PROSPECTIVE PAYMENT SYSTEM AND CONSOLIDATED BILLING FOR SKILLED 
NURSING FACILITIES--UPDATE FOR FY 2004 (CMS-1469-P)

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

RIN: 0938-AL90
_______________________________________________________________________




1029. CHANGES TO THE HOSPITAL OUTPATIENT PROSPECTIVE PAYMENT SYSTEM AND 
CALENDAR YEAR 2004 PAYMENT RATES (CMS-1471-P)

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

RIN: 0938-AL91
_______________________________________________________________________




1030. PROSPECTIVE PAYMENT SYSTEM FOR LONG-TERM CARE HOSPITALS: FY 2004 
(CMS-1472-P)

Priority: Substantive, Nonsignificant

Legal Authority: BBRA 1999, sec 123; BIPA 2000, sec 307(b)

CFR Citation: 42 CFR 412; 42 CFR 413

Legal Deadline: None

Abstract: This rule updates the Prospective Payment System for Medicare 
payment of inpatient hospital.

[[Page 74530]]

It implements section 123 of the Medicare, Medicaid, and SCHIP Balanced 
Budget Refinement Act of 1999 and section 307(b) of the Medicare, 
Medicaid, and SCHIP Benefits Improvement and Protection Act of 2000.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            05/00/03

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Tzvi Hefter, 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-AL92
_______________________________________________________________________




1031. HOME HEALTH PROSPECTIVE PAYMENT SYSTEM RATE UPDATE FOR FY 2004 
(CMS-1473-NC)

Priority: Other Significant

Legal Authority: Not Yet Determined

CFR Citation: Not Yet Determined

Legal Deadline: Other, Statutory, June 28, 2003, notice must be 
published by 06/28/2003 deadline in order to meet statutory effective 
date of 10/01/2003.

Abstract: This notice with comment period sets forth an update to the 
60-day national episode rates and the national per-visit amounts under 
the Medicare prospective payment system for home health agencies for FY 
2004. (We must publish this notice by 06/28/04 to meet the statutory 
effective date of 10/01/04.)

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Notice                          06/00/03

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Susan Levy, Health Insurance Specialist, Department of 
Health and Human Services, Centers for Medicare & Medicaid Services, 
C5-08-27, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-9364

RIN: 0938-AL94
_______________________________________________________________________




1032. PROSPECTIVE PAYMENT SYSTEM FOR INPATIENT REHABILITATION HOSPITALS 
(CMS-1474-P)

Priority: Substantive, Nonsignificant

Legal Authority: Social Security Act, sec 1886(j); PL 105-33; PL 106-
554; PL 106-113

CFR Citation: 42 CFR 412 to 413

Legal Deadline: None

Abstract: This proposed rule will update rates for the prospective 
payment systems for inpatient rehabilitation facilities for FY 2004.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Proposed Rule                   04/00/03

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Robert Kuhl, Department of Health and Human Services, 
Centers for Medicare & Medicaid Services, C4-11-06, 7500 Security 
Boulevard, Baltimore, MD 21244-1850
Phone: 410 786-4597

RIN: 0938-AL95
_______________________________________________________________________




1033. REVISIONS TO PAYMENT POLICIES UNDER THE PHYSICIAN FEE SCHEDULE FOR 
CALENDAR YEAR 2004 (CMS-1476-P)

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

RIN: 0938-AL96
_______________________________________________________________________




1034. [bull] NONDISCRIMINATION IN POST-HOSPITAL REFERRAL TO HOME HEALTH 
AGENCIES AND OTHER ENTITIES (CMS-1224-P)

Priority: Substantive, Nonsignificant

Legal Authority: PL 105-33, Sec 4321 of the BBA

CFR Citation: 42 CFR 482

Legal Deadline: None

Abstract: This proposed rule would establish a process for collecting 
and maintaining information about hospitals referring Medicare patients 
to home health agencies (HHAs) with which the hospitals have a 
financial interest. Moreover, collected information would be made 
available to the public in order to enhance its understanding and 
awareness regarding the availability of Medicare-certified HHAs to 
serve the Medicare population.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            11/00/02

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Elizabeth Carmody, Department of Health and Human 
Services, Centers for Medicare & Medicaid Services, C4-10-07, 7500 
Security Boulevard, Baltimore, MD 21244
Phone: 410 786-7533

RIN: 0938-AM01
_______________________________________________________________________




1035. [bull] MEDICAID HOME AND COMMUNITY-BASED SERVICES WAIVERS (CMS-
2162-P)

Priority: Substantive, Nonsignificant

Legal Authority: Sec 1915(c) of the Social Security Act

CFR Citation: 42 CFR 441.300

Legal Deadline: None

Abstract: This proposed rule incorporates New Freedom Initiative 
recommendations/proposals into the HCBS waiver program to allow States 
greater flexibility in creating community-based long term care 
alternatives for eligible persons.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Proposed Rule                   06/00/03

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Mary Clarkson, Health Insurance Specialist, Department 
of Health and Human Services, Centers for Medicare & Medicaid Services, 
S2-14-26, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-5918

RIN: 0938-AM05

[[Page 74531]]

_______________________________________________________________________




1036. [bull] TICKET TO WORK MEDICAID INFRASTRUCTURE GRANT (CMS-2165-N)

Priority: Routine and Frequent

Legal Authority: Social Security Act, sec 203; PL 106-170

CFR Citation: None

Legal Deadline: None

Abstract: This notice is an annual event that gives State agencies 
official notification of the Medicaid Grant Infrastructure Grant 
solicitation process.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Notice                          02/00/03

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Federalism:  Undetermined

Agency Contact: Joe A Razes, Health Insurance Specialist, Department of 
Health and Human Services, Centers for Medicare & Medicaid Services, 
S2-12-28, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-6126
Email: [email protected]

RIN: 0938-AM11
_______________________________________________________________________




1037. [bull] REVISIONS TO AVERAGE WHOLESALE PRICE METHODOLOGY (CMS-1229-
P)

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

RIN: 0938-AM12
_______________________________________________________________________




1038. [bull] CRITERIA FOR DETERMINING WHETHER A DRUG IS CONSIDERED 
USUALLY SELF-ADMINISTERED (CMS-1228-P)

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

Legal Authority: 1861(s)(2)(B)

CFR Citation: Not Yet Determined

Legal Deadline: None

Abstract: This proposed rule would solicit comments on the criteria to 
determine whether a drug is considered usually self-administered and 
therefore, not covered under part B of Medicare.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Proposed Rule                   09/00/03

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected: No

Government Levels Affected: Undetermined

Federalism:  Undetermined

Agency Contact: Robert Niemann, Department of Health and Human 
Services, Centers for Medicare & Medicaid Services, 7500 Security 
Boulevard, Baltimore, MD 21244
Phone: 410 786-4569

RIN: 0938-AM13
_______________________________________________________________________




1039. [bull] ELECTRONIC MEDICARE CLAIMS SUBMISSION (CMS-0008-P)

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

RIN: 0938-AM22
_______________________________________________________________________




1040. [bull] LIABILITY OF THIRD PARTIES TO PAY FOR CARE AND SERVICES 
(CMS-2080-P)

Priority: Substantive, Nonsignificant

Legal Authority: Sec 13622 of OBRA `93; Sec 4741(a)(2) of BBA `97; Sec 
4701(b) of BBA `97

CFR Citation: 42 CFR Part 433

Legal Deadline: None

Abstract: This rule would amend regulations governing third party 
liability. It adds Employee Retirement Income Security Act of 1974 
(ERISA) plans, service benefit plans, and health maintenance 
organizations to the definition of liable third parties.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Proposed Rule                   03/00/03

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: State

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-AM24
_______________________________________________________________________




1041. [bull] MEDICAID DEFINITION OF QUALIFIED SPEECH PATHOLOGISTS AND 
AUDIOLOGISTS (CMS-2132-P)

Priority: Substantive, Nonsignificant

Legal Authority: Sec 1905(a)(11) of the Social Security Act; 42 USC 
1396d

CFR Citation: 42 CFR 440.110(a)

Legal Deadline: None

Abstract: This proposed rule would set forth changes in existing 
Medicaid regulations to establish provider standards consistent with 
those in the Medicare program. The Medicare definition of speech 
pathologist/audiologist defers to the States for the definition, and if 
States do not license these providers, defines specific training and 
education standards.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Proposed Rule                   12/00/02

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Linda Peltz, Center for Medicaid and State Operations, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, C4-25-02, 7500 Security Boulevard, Baltimore, MD 
21244-1850
Phone: 410 786-3399

RIN: 0938-AM26
_______________________________________________________________________




1042. [bull] MEDICAID ESTATE RECOVERIES (CMS-2083-P)

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

Unfunded Mandates: Undetermined

Legal Authority: Not Yet Determined

CFR Citation: Not Yet Determined

Legal Deadline: None

Abstract: This proposed rule would require States to seek adjustment or 
recovery from the estates of Medicaid beneficiaries for amounts 
correctly spent by Medicaid on permanently institutionalized 
individuals (any age) and aged 55 or older for certain services.

[[Page 74532]]

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Proposed Rule                   09/00/03

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Federalism:  Undetermined

Agency Contact: Ingrid Osborne, Center for Medicaid and State 
Operations, Department of Health and Human Services, Centers for 
Medicare & Medicaid Services, S2-16-25, 7500 Security Boulevard, 
Baltimore, MD 21244-1850
Phone: 410 786-4461

RIN: 0938-AM30
_______________________________________________________________________


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


Centers for Medicare & Medicaid Services (CMS)



_______________________________________________________________________




1043. REVISION OF MEDICARE/MEDICAID HOSPITAL CONDITIONS OF PARTICIPATION 
(CMS-3745-F)

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

RIN: 0938-AG79
_______________________________________________________________________




1044. HOME HEALTH AGENCY (HHA) CONDITIONS OF PARTICIPATION (COPS) (CMS-
3819-FC)

Priority: Other Significant

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

CFR Citation: 42 CFR 484

Legal Deadline: None

Abstract: This final rule with comment period revises the existing CoPs 
that HHAs must meet to participate in the Medicare program. The 
requirements focus on the actual care delivered to patients by HHAs, 
reflect an interdisciplinary view of patient care, allow HHAs greater 
flexibility in meeting quality standards, and eliminate unnecessary 
procedural requirements. These changes are an integral part of the 
Administration's efforts to achieve broad-based improvements and 
measurements of the quality of care furnished through Federal programs, 
while at the same time reducing procedural burdens on providers.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            03/10/97                    62 FR 11005
NPRM Comment Period End         06/09/97
Final Rule                      07/00/03

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
_______________________________________________________________________




1045. MEDICARE AND MEDICAID PROGRAMS; TERMS, DEFINITIONS, AND ADDRESSES: 
TECHNICAL AMENDMENTS (CMS-9877-F)

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 final 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                            01/25/02                     67 FR 3641
NPRM Comment Period End         03/26/02
Final Rule                      06/00/03

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
_______________________________________________________________________




1046. HEALTH INSURANCE REFORM: STANDARD UNIQUE HEALTH CARE PROVIDER 
IDENTIFIER (CMS-0045-F)

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

RIN: 0938-AH99
_______________________________________________________________________




1047. 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 final rule would extend appeal rights to all suppliers 
whose enrollment applications for Medicare billing privileges are 
disallowed by a carrier or whose Medicare billing privileges are 
revoked, except for those suppliers covered under other existing 
appeals provisions of our regulations.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            10/25/99                    64 FR 57431
Final Rule                      04/00/03

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: None

[[Page 74533]]

Agency Contact: Charles Waldhauser, 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 
Boulevard, Baltimore, MD 21244
Phone: 410 786-6479

RIN: 0938-AI49
_______________________________________________________________________




1048. SECURITY STANDARDS (CMS-0049-F)

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

RIN: 0938-AI57
_______________________________________________________________________




1049. 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 final rule follows an Interm Final with Comment that 
removed all references in the Medicare regulations to specific 
religious institutions to include all religious nonmedical 
institutions.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              11/30/99                    64 FR 67028
Final Action                    08/00/03

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
_______________________________________________________________________




1050. 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 final rule will require State agencies to contract with 
managed care organizations and to monitor and evaluate their 
performances 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
Final Rule                      12/00/02

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, Department of Health and Human Services, Centers for 
Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, MD 
21244
Phone: 410 786-1177

RIN: 0938-AJ06
_______________________________________________________________________




1051. REPORTING OUTCOME AND ASSESSMENT INFORMATION SET (OASIS) DATA AS 
PART OF THE CONDITIONS OF PARTICIPATION FOR HOME HEALTH AGENCIES (CMS-
3006-IFC)

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              01/25/99                     64 FR 3748
Interim Final Rule              04/00/03

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
_______________________________________________________________________




1052. 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 Medicare certification and payment 
requirements for rural health clinics (RHCs), as required by section 
4205 of the Balanced Budget Act of 1997. It changes the definition of a 
qualifying rural shortage area in which a Medicare RHC must be located; 
establishes criteria for identifying RHCs essential to delivery of 
primary care services that we can continue to approve as Medicare RHCs 
in areas no longer designated as medically underserved; and limits 
nonphysician practitioner staffing requirements. This rule imposes 
payment limits on provider-based RHCs and prohibits the use of RHC 
space, professional staff, equipment, and other RHC resources by 
another Medicare entity. The rule also requires RHCs to establish a 
quality

[[Page 74534]]

assessment and performance improvement program.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            02/28/00                    65 FR 10450
Final Rule                      01/00/03

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: Federal

Agency Contact: David Worgo, 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-AJ17
_______________________________________________________________________




1053. 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 final rule revises requirements for hospitals that 
transfuse blood and blood products regarding written procedures, 
quarantine, testing, and counseling for hepatitis C virus (HCV) and 
records maintenance.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

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

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
_______________________________________________________________________




1054. 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 final rule addresses standards of practices that 
residential treatment facilities providing inpatient psychiatric 
services for individuals under age 21 must meet with regard to the use 
of restraints and seclusion.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              01/22/01                     66 FR 7148
60-Day Delay of Effective Date 
To 05/22/2001                   03/21/01                    66 FR 15800
Interim Final Rule Comment 
Period End                      03/23/01
Interim Final Rule Effective    03/23/01
Interim Final Rule Amendment 
with Clarification              05/22/01                    66 FR 28110
Interim Final Rule Comment 
Period End                      07/23/01
Final Action                    06/00/03

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Larry Cutler, 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: 410 786-5903

RIN: 0938-AJ96
_______________________________________________________________________




1055. 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 final rule 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.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              01/07/98                      63 FR 687
Final Action                    11/00/02

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, C5-08-27, Center 
for Medicare Management, 7500 Security Boulevard, Baltimore, MD 21228
Phone: 410 786-5655
Email: [email protected]

RIN: 0938-AJ97
_______________________________________________________________________




1056. 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).

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Action                    11/00/02

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

[[Page 74535]]

_______________________________________________________________________




1057. FIRE SAFETY REQUIREMENTS FOR RNHCI, ASC, HOSPICES, PACE, 
HOSPITALS, AND LONG-TERM CARE FACILITIES AND ICFS FOR THE MENTALLY 
RETARDED (CMS-3047-F)

Priority: Other Significant

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 final rule adopts the 2000 edition of the National Fire 
Protection Association's Life Safety Code as the fire standards for 
Religious Non-Medical Health Care Institutions, Ambulatory Surgery 
Centers, Hospices that provide in-patient services, Programs of All-
Inclusive Care for the Elderly, Hospitals, Long-Term Care Facilities, 
and Intermediate Care Facilities for the Mentally Retarded.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Proposed Rule                   10/26/01                    66 FR 54179
Final Action                    11/00/02

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
_______________________________________________________________________




1058. HOSPITAL CONDITIONS OF PARTICIPATION: QUALITY ASSESSMENT AND 
PERFORMANCE IMPROVEMENTS (QAPI) (CMS-3050-F)

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

RIN: 0938-AK40
_______________________________________________________________________




1059. 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 final rule sets forth several improvements to the 
Medicare+Choice (M+C) appeal and grievance procedures. This rule 
addresses the termination date of provider services, independent review 
process, and discharge notices.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            01/24/01                     66 FR 7593
Final Rule                      02/00/03

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
_______________________________________________________________________




1060. REVIEW OF NATIONAL COVERAGE DETERMINATIONS AND LOCAL COVERAGE 
DETERMINATIONS (CMS-3063-F)

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

RIN: 0938-AK60
_______________________________________________________________________




1061. REVISED PROCESS FOR MAKING MEDICARE COVERAGE DETERMINATIONS (NCDS) 
(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 Ddecisions.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Notice                          12/00/02

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
_______________________________________________________________________




1062. HEALTH INSURANCE REFORM: MODIFICATIONS TO STANDARDS FOR ELECTRONIC 
TRANSACTIONS (CMS-0003-F)

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

RIN: 0938-AK64
_______________________________________________________________________




1063. 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.

Legal Authority: 42 USC 1877

CFR Citation: 42 CFR 411

Legal Deadline: None

Abstract: This final rule with comment period incorporates into 
regulations the provisions concerning ownership and investment 
exceptions in paragraphs (c) and (d) and the compensation exceptions in 
paragraph (e) of Section 1877 of the Social Security Act.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Action                    05/00/03

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses, Organizations

Government Levels Affected: None

Agency Contact: Joanne Sinsheimer, Technical Advisor, CMM, Department 
of Health and Human Services, Centers for Medicare & Medicaid Services, 
7500 Security Boulevard, Baltimore, MD 21244-1850
Phone: 410 786-4620

RIN: 0938-AK67

[[Page 74536]]

_______________________________________________________________________




1064. MEDICAID MANAGED CARE; NEW PROVISIONS (CMS-2104-F2)

Priority: Info./Admin./Other

Legal Authority: BIPA `00

CFR Citation: 42 CFR 400

Legal Deadline: None

Abstract: This notice will correct typographical errors, cross 
references, and other discrepancies, in the rule published on June 14, 
2002.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            08/20/01                    66 FR 43613
NPRM Comment Period End         10/19/01
Final Rule                      06/14/02                    67 FR 40989
Correction Notice               11/00/02

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Bruce Johnson, Center for Medicaid and State 
Operations, Department of Health and Human Services, Centers for 
Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, MD
Phone: 410 786-0615

Deirdre Duzor, Department of Health and Human Services, Centers for 
Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, MD 
21244
Phone: 410 786-4626

RIN: 0938-AK96
_______________________________________________________________________




1065. MODIFICATIONS TO THE STATE CHILDREN'S HEALTH INSURANCE PROGRAM 
(CMS-2006-F)

Priority: Substantive, Nonsignificant

Legal Authority: PL 105-33

CFR Citation: 42 CFR 435; 42 CFR 436; 42 CFR 457

Legal Deadline: None

Abstract: This final rule responds to public comments received and will 
revise certain provisions to the State Children's Health Insurance 
Program (SCHIP) final rule, published on January 11, 2002.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              06/25/01                    66 FR 33810
Interim Final Rule Comment 
Period End                      07/26/01
Interim Final Rule Effective    08/24/01
Final Rule                      05/00/03

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
_______________________________________________________________________




1066. 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)(1)(O) of the Social Security Act, as 
amended

CFR Citation: 42 CFR 413.134

Legal Deadline: None

Abstract: This final rule responds to public comments received and 
makes technical corrections to the Medicare provider reimbursement 
regulations that set forth requirements related to allowable costs.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Action                    04/00/03

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
_______________________________________________________________________




1067. REQUIREMENTS FOR PAID FEEDING ASSISTANTS IN LONG-TERM CARE 
FACILITIES (CMS-2131-F)

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

Unfunded Mandates: Undetermined

Legal Authority: Sec 1819(a) to (f) of the Social Security Act; sec 
1919(a) to (g) of the Social Security Act; PL 100-203

CFR Citation: 42 CFR 483.73; 42 CFR 483.75(c)

Legal Deadline: None

Abstract: This final rule would allow long-term care facilities to use 
paid feeding assistants to supplement the services of certified nurse 
aides. If facilities choose this option, feeding assistants must 
complete a specified training program.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Proposed Rule                   03/29/02                    67 FR 15149
Comment Period End              05/28/02
Final Rule                      03/00/03

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected: Businesses

Government Levels Affected: State, Federal

Agency Contact: Nola Petrovich, Department of Health and Human 
Services, Centers for Medicare & Medicaid Services, S2-14-26, 7500 
Security Boulevard, Baltimore, MD 21244
Phone: 410 786-4671

RIN: 0938-AL18
_______________________________________________________________________




1068. CHANGES TO THE HOSPITAL OUTPATIENT PROSPECTIVE PAYMENT SYSTEM AND 
CALENDAR YEAR 2003 PAYMENT RATES (CMS-1206-F)

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

Legal Authority: 42 USC 1395(L); BBA `97; BBRA `99; BIPA `00

CFR Citation: Not Yet Determined

Legal Deadline: None

Abstract: This final rule revises the Medicare hospital outpatient 
payment system beginning 01/01/03.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Notice                          03/18/02                    67 FR 11969

[[Page 74537]]

Proposed Rule                   08/09/02                    67 FR 52092
Comment Period End              10/07/02
Final Action                    11/00/02

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: Federal

Agency Contact: Cindy Read, Department of Health and Human Services, 
Centers for Medicare & Medicaid Services, 7500 Security Boulevard, 
Baltimore, MD 21244
Phone: 410 786-0378

RIN: 0938-AL19
_______________________________________________________________________




1069. REVISIONS TO PAYMENT POLICIES UNDER THE PHYSICIAN FEE SCHEDULE FOR 
CALENDAR YEAR 2003 (CMS-1204-FC)

Priority: Other Significant. Major under 5 USC 801.

Legal Authority: 42 USC 1395W-4

CFR Citation: 42 CFR 410; 42 CFR 414

Legal Deadline: None

Abstract: This rule would make several changes affecting Medicare part 
B payment.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Proposed Rule                   06/28/02                    67 FR 43846
Final Action                    11/00/02

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: Federal

Agency Contact: Diane Milstead, Department of Health and Human 
Services, Centers for Medicare & Medicaid Services, 7500 Security 
Boulevard, Baltimore, MD 21244
Phone: 410 786-3355

RIN: 0938-AL21
_______________________________________________________________________




1070. HEALTH COVERAGE PORTABILITY FOR GROUP HEALTH PLANS AND GROUP 
HEALTH INSURANCE ISSUERS (CMS-2151-F)

Priority: Other Significant. Major under 5 USC 801.

Legal Authority: 42 USC 300gg; PL 104-191

CFR Citation: 45 CFR 144.103; 45 CFR 146.101; 45 CFR 146.111; 45 CFR 
146.113; 45 CFR 146.115; 45 CFR 146.117; 45 CFR 146.119; 45 CFR 
146.145; ...

Legal Deadline: None

Abstract: This final rule addresses limitations on preexisting 
exclusions periods and requests for special enrollments.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              04/08/97                    62 FR 16894
Interim Final Rule Comment 
Period End                      07/07/97
Interim Final Rule Effective    07/07/97
Final Action                    05/00/03

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: State, Local, Federal

Agency Contact: David Mlawsky, Health Insurance Specialist, Department 
of Health and Human Services, Centers for Medicare & Medicaid Services, 
S3-16-26, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-6851

RIN: 0938-AL43
_______________________________________________________________________




1071. INTERIM FINAL AMENDMENT FOR MENTAL HEALTH PARITY (CMS-2152-IFC)

Priority: Substantive, Nonsignificant

Legal Authority: 42 USC 2705; PL 107-116; PL 104-191

CFR Citation: 45 CFR 146.136

Legal Deadline: None

Abstract: This interim final rule changes the sunset date of 
regulations under the Mental Health Parity Act of 1996.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              11/22/97                    62 FR 66932
Interim Final Rule Effective    01/01/98
Interim Final Rule Comment 
Period End                      03/23/98
Interim Final Rule              04/00/03

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: State, Local

Agency Contact: David Mlawsky, Health Insurance Specialist, Department 
of Health and Human Services, Centers for Medicare & Medicaid Services, 
S3-16-26, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-6851

RIN: 0938-AL44
_______________________________________________________________________




1072. ELECTRONIC SUBMISSION OF COST REPORTS (CMS-1199-F)

Priority: Substantive, Nonsignificant

Legal Authority: Social Security Act, sec 1815(a); Social Security Act, 
sec 1833(e)

CFR Citation: 42 CFR 413.24

Legal Deadline: None

Abstract: This final rule would establish the requirement for community 
mental health cneters, ESRD facilities, hospices, rural health clinics, 
and federally qualified health centers to file cost reports in a 
standardized electronic format. This rule would also provide a delay or 
waiver of this requirement where implementation would result in 
financial hardship. The provisions of this rule would allow for more 
accurate preparation and more efficient processing of each cost report.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Proposed Rule                   07/26/02                    67 FR 48840
Final Action                    05/00/03

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Thomas Talbott, Center for Medicare Management, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, C5-01-01, 7500 Security Boulevard, Baltimore, MD 
21244-1850
Phone: 410 786-4592

RIN: 0938-AL51

[[Page 74538]]

_______________________________________________________________________




1073. INPATIENT HOSPITAL DEDUCTIBLE AND HOSPITAL AND EXTENDED CARE 
SERVICES COINSURANCE AMOUNTS FOR CALENDAR YEAR 2003 (CMS-8013-N)

Priority: Other Significant

Legal Authority: 42 USC 1395e-2(g)(2)

CFR Citation: None

Legal Deadline: None

Abstract: This notice announces the inpatient hospital deductible and 
the hospital and extended care services coinsurance amounts for 
services furnished in calendar year 2003 under the Medicare hospital 
insurance program (part A). The Medicare statute specifies the formula 
used to determine these amounts.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Notice                          11/00/02

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Clare McFarland, Deputy Directory, Medicare and 
Medicaid Cost Estimates Group, Department of Health and Human Services, 
Centers for Medicare & Medicaid Services, N3-26-24, 7500 Security 
Boulevard, Baltimore, MD 21244
Phone: 410 786-6390

RIN: 0938-AL56
_______________________________________________________________________




1074. PROGRAM FOR ALL-INCLUSIVE CARE FOR THE ELDERLY (PACE): PROGRAM 
REVISIONS (CMS-1201-F)

Priority: Other Significant

Legal Authority: 42 USC 1395, as revised by sec 903 of BIPA; 42 USC 
1396, as revised by sec 903 of BIPA

CFR Citation: 42 CFR 460ff

Legal Deadline: None

Abstract: This rule revises the interim final rule with comment period 
that established requirements for Programs of All-Inclusive Care for 
the Elderly (PACE) under the Medicare and Medicaid programs. These are 
pre-paid, capitated programs for beneficiaries who meet special 
eligibility requirements and who elect to enroll. The revisions in this 
rule will implement section 903 of BIPA.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              10/01/02                    67 FR 61496
Final Action                    09/00/03

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Organizations

Government Levels Affected: State, Tribal

Federalism:  Undetermined

Agency Contact: Janet Samen, Center for Medicare Management, Department 
of Health and Human Services, Centers for Medicare & Medicaid Services, 
C4-08-15, 7500 Security Boulevard, Baltimore, MD 21244-1850
Phone: 410 786-9161

RIN: 0938-AL59
_______________________________________________________________________




1075. MONTHLY ACTUARIAL RATES AND MONTHLY SUPPLEMENTARY MEDICAL 
INSURANCE PREMIUM RATE BEGINNING JANUARY 1, 2003 (CMS-8014-N)

Priority: Economically Significant

Legal Authority: 42 CFR 1395r; Social Security Act, sec 1839

CFR Citation: None

Legal Deadline: NPRM, Statutory, September 27, 2002.

Abstract: This notice announces the monthly actuarial rates for aged 
and disabled enrollees in the Medicare Supplementary Medical Insurance 
(SMI) program for 2003. It also announces the monthly SMI premium to be 
paid by all enrollees during 2003.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Notice                          11/00/02

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Carter S. Warfield, Office of Medicare and Medicaid 
Cost Estimates, Department of Health and Human Services, Centers for 
Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, MD 
21244
Phone: 410 786-6396

RIN: 0938-AL63
_______________________________________________________________________




1076. PART A PREMIUMS FOR 2003 FOR THE UNINSURED AGED AND FOR CERTAIN 
DISABLED INDIVIDUALS WHO HAVE EXHAUSTED OTHER ENTITLEMENT (CMS-8015-N)

Priority: Other Significant

Legal Authority: 42 USC 1395i-2(d)(2); 42 USC 1395i-2a(d)(2)

CFR Citation: None

Legal Deadline: None

Abstract: This notice announces the hospital insurance premium for 
calendar year 2003 under Medicare's hospital insurance program (part A) 
for the uninsured aged and for certain disabled individuals who have 
exhausted other entitlement.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Notice                          11/00/02

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Clare McFarland, Deputy Directory, Medicare and 
Medicaid Cost Estimates Group, Department of Health and Human Services, 
Centers for Medicare & Medicaid Services, N3-26-24, 7500 Security 
Boulevard, Baltimore, MD 21244
Phone: 410 786-6390

RIN: 0938-AL69
_______________________________________________________________________




1077. STATE ALLOTMENTS FOR PAYMENT OF MEDICARE PART B PREMIUMS FOR 
QUALIFYING INDIVIDUALS; FEDERAL FISCAL YEAR 2002 (CMS-2136-FN)

Priority: Other Significant. Major under 5 USC 801.

Legal Authority: Social Security Act, sec 1902(a)(10); Social Security 
Act, sec 1933; 42 USC 139; PL 105-33

CFR Citation: None

Legal Deadline: None

Abstract: This final notice announces the Federal FY 2002 allotments 
that are available for State agencies to pay Medicare part B premiums 
for two distinct categories of low-income Medicare beneficiaries. The 
eligible groups are called qualified individuals.

[[Page 74539]]

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Proposed Notice                 08/30/02                    67 FR 55851
Final Notice                    05/00/03

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

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-AL79
_______________________________________________________________________




1078. CHANGES TO THE HOSPITAL INPATIENT PROSPECTIVE PAYMENT SYSTEM AND 
FY 2004 RATES (CMS-1470-N)

 Regulatory Plan: This entry is Seq. No. 63 in part II of this issue of 
the Federal Register.

RIN: 0938-AL89
_______________________________________________________________________




1079. [bull] FEE SCHEDULE FOR PAYMENT OF AMBULANCE SERVICES--UPDATE FOR 
CY 2003 (CMS-1220-N)

Priority: Other Significant

Legal Authority: 42 USC 1395m(l)(1)

CFR Citation: None

Legal Deadline: None

Abstract: This notice updates the fee schedule published 2/27/02 for 
ambulance services under the Medicare program, implementing section 
1834(l) of the Social Security Act.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Notice                          11/00/02

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Robert Niemann, Department of Health and Human 
Services, Centers for Medicare & Medicaid Services, 7500 Security 
Boulevard, Baltimore, MD 21244
Phone: 410 786-4569

RIN: 0938-AL97
_______________________________________________________________________




1080. [bull] UPDATE OF THE LIST OF COVERED PROCEDURES FOR AMBULATORY 
SURGICAL CENTERS EFFECTIVE JANUARY 1, 2003 (CMS-1885-FC)

Priority: Other Significant

Legal Authority: 1883(i)(l) and (2) of the Social Security Act

CFR Citation: 42 CFR 416

Legal Deadline: None

Abstract: This final rule with comment period will make additions to 
and deletions from the current list of Medicare covered Ambulatory 
Surgical Centers procedures.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Action                    12/00/02

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: Undetermined

Agency Contact: Bob Cereghino, Department of Health and Human Services, 
Centers for Medicare & Medicaid Services, C4-03-06, 7500 Security 
Boulevard, Baltimore, MD 21244
Phone: 410 786-4645

Related RIN: Related To 0938-AH81
RIN: 0938-AM02
_______________________________________________________________________




1081. [bull] COMPREHENSIVE EMPLOYMENT DEMONSTRATION (CMS-2163-N)

Priority: Other Significant

Legal Authority: PL 106-170, sec 203

CFR Citation: None

Legal Deadline: None

Abstract: This notification of funding availability announces the 
establishment of the comprehensive employment opportunities 
demonstration whereby up to $9.0 million in funding will be awarded via 
a competitive process to remove barriers to employment for individuals 
with a disability.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Notice                          02/00/03

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Karen L. Tritz, Department of Health and Human 
Services, Centers for Medicare & Medicaid Services, S2-14-26, 7500 
Security Boulevard, Baltimore, MD 21244
Phone: 410 786-0789
Fax: 410 786-9004
Email: [email protected]

RIN: 0938-AM10
_______________________________________________________________________




1082. [bull] NONDISCRIMINATION IN HEALTH COVERAGE IN THE GROUP MARKET 
(CMS-2022-F)

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

Legal Authority: 42 USC 300gg

CFR Citation: 45 CFR 146.121

Legal Deadline: None

Abstract: This document contains final rules governing the provisions 
prohibiting discrimination based on a health factor for group health 
plans and issuers of health insurance coverage offered in connection 
with a group health plan.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              04/08/97                    62 FR 16894
Interim Final Rule Comment 
Period End                      07/17/97
Interim Final Rule Effective    07/17/97
Interim Final Rule              01/08/01                     66 FR 1378
Interim Final Rule Effective    03/09/01
Interim Final Rule Comment 
Period End                      04/09/01
Final Action                    06/00/03

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses, Governmental Jurisdictions

Government Levels Affected: State, Local

Agency Contact: David Mlawsky, Health Insurance Specialist, Department 
of Health and Human Services, Centers for Medicare & Medicaid Services, 
S3-16-26, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-6851

RIN: 0938-AM14

[[Page 74540]]

_______________________________________________________________________




1083. [bull] BONA FIDE WELLNESS PROGRAMS (CMS-2078-F)

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

Legal Authority: 42 USC 300gg

CFR Citation: 45 CFR 146.121(f)

Legal Deadline: None

Abstract: This final rule implements and clarifies the term ``bona fide 
wellness program'' as it relates to regulations implementing the 
nondiscrimination provisions of the Internal Revenue Code, the Employee 
Retirement Income Security Act, and the Public Health Service Act, as 
added by the Health Insurance Portability and Accountability Act of 
1996.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              04/08/97                    62 FR 16894
Interim Final Rule Comment 
Period End                      07/07/97
Interim Final Rule Effective    07/07/97
NPRM                            01/08/01                     66 FR 1421
NPRM Comment Period End         04/09/01
Final Action                    07/00/03

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses, Governmental Jurisdictions

Government Levels Affected: State, Local

Agency Contact: David Mlawsky, Health Insurance Specialist, Department 
of Health and Human Services, Centers for Medicare & Medicaid Services, 
S3-16-26, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-6851

RIN: 0938-AM15
_______________________________________________________________________




1084. [bull] TIME LIMITATION ON RECALCULATIONS AND DISPUTES UNDER THE 
DRUG REBATE PROGRAM (CMS-2175-IFC)

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

Legal Authority: 42 USC 1396r-8

CFR Citation: 42 CFR 447.534

Legal Deadline: None

Abstract: This rule will establish a three year time limitation on drug 
manufacturer's requests to recalculate their drug prices for the 
purposes of reporting data to CMS, as well as manufacturer's ability to 
dispute claims for rebates.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              12/00/02

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: State, Federal

Federalism:  Undetermined

Agency Contact: Marge Lee Watchorn, Health Insurance Specialist, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, S1-01-16, 7500 Security Boulevard, Baltimore, MD 
21244
Phone: 410 786-4361

RIN: 0938-AM20
_______________________________________________________________________




1085. [bull] PHYSICIANS' REFERRALS TO HEALTH CARE ENTITIES WITH WHICH 
THEY HAVE FINANCIAL RELATIONSHIPS; EXTENSION OF PARTIAL DELAY OF 
EFFECTIVE DATE OF THE ``SET IN ADVANCE'' PROVISION (CMS-1809-IFC2)

Priority: Other Significant

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

CFR Citation: 42 CFR 411.354

Legal Deadline: None

Abstract: This final rule temporarily delays for six months or until 
publication of phase II the effective date of the last sentence of the 
``set in advance'' provision in section 411.354(d)(1) contained in the 
rule entitled ``Medicare and Medicaid Programs; Physicians' Referrals 
to Health Care Entities With Which They Have Financial Relationships,'' 
published in the Federal Register on January 4, 2001 (66 FR 856).

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Extension of Partial Delay of 
Final Rule Effective Date       11/00/02

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Joanne Sinsheimer, Technical Advisor, CMM, Department 
of Health and Human Services, Centers for Medicare & Medicaid Services, 
7500 Security Boulevard, Baltimore, MD 21244-1850
Phone: 410 786-4620

Related RIN: Related To 0938-AL29
RIN: 0938-AM21
_______________________________________________________________________




1086. [bull] INPATIENT HOSPITAL DEDUCTIBLE AND HOSPITAL AND EXTENDED 
CARE SERVICES COINSURANCE AMOUNTS FOR 2004 (CMS-8016-N)

Priority: Other Significant

Legal Authority: 42 USC 1395e-2(g)(2)

CFR Citation: None

Legal Deadline: None

Abstract: This notice announces the inpatient hospital deductible and 
the hospital and extended care services coinsurance amounts for 
services furnished in calendar year 2004 under Medicare's hospital 
insurance program (Medicare part A). The Medicare statute specifies the 
formulae used to determine these amounts.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Notice                          10/00/03

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Clare McFarland, Deputy Directory, Medicare and 
Medicaid Cost Estimates Group, Department of Health and Human Services, 
Centers for Medicare & Medicaid Services, N3-26-24, 7500 Security 
Boulevard, Baltimore, MD 21244
Phone: 410 786-6390

RIN: 0938-AM31
_______________________________________________________________________




1087. [bull] MONTHLY ACTUARIAL RATES AND MONTHLY SUPPLEMENTARY MEDICAL 
INSURANCE PREMIUM RATE BEGINNING JANUARY 1, 2004 (CMS-8017-N)

Priority: Other Significant

Legal Authority: 42 CFR 1395r; Social Security Act, Sec 1839

CFR Citation: 42 CFR 407; 42 CFR 408

Legal Deadline: NPRM, Statutory, September 27, 2002.

[[Page 74541]]

Abstract: This notice announces the monthly actuarial rates for aged 
(age 65 and over) and disabled (underage 65) enrollees in the Medicare 
Supplementary Medical Insurance (SMI) program for 2004. It also 
announces the monthly SMI premium to be paid by all enrollees during 
2004.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Notice                          10/00/03

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Carter S. Warfield, Office of Medicare and Medicaid 
Cost Estimates, Department of Health and Human Services, Centers for 
Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, MD 
21244
Phone: 410 786-6396

RIN: 0938-AM32
_______________________________________________________________________




1088. [bull] PART A PREMIUMS FOR 2004 FOR THE UNINSURED AGED AND FOR 
CERTAIN DISABLED INDIVIDUALS WHO HAVE EXHAUSTED OTHER ENTITLEMENT (CMS-
8018-N)

Priority: Other Significant

Legal Authority: 42 USC 1395i-2(d)(2); 42 USC 1395i-2a(d)(2)

CFR Citation: None

Legal Deadline: None

Abstract: This notice announces the hospital insurance premium for 
calendar year 2004 under Medicare's hospital insurance program (part A) 
for the uninsured aged and for certain disabled individuals who have 
exhausted other entitlement.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Notice                          10/00/03

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Clare McFarland, Deputy Directory, Medicare and 
Medicaid Cost Estimates Group, Department of Health and Human Services, 
Centers for Medicare & Medicaid Services, N3-26-24, 7500 Security 
Boulevard, Baltimore, MD 21244
Phone: 410 786-6390

RIN: 0938-AM33
_______________________________________________________________________




1089. [bull] APPLICATION OF EMERGENCY MEDICAL AND TREATMENT ACT (EMTALA) 
(CMS-1063-F)

 Regulatory Plan: This entry is Seq. No. 64 in part II of this issue of 
the Federal Register.

RIN: 0938-AM34
_______________________________________________________________________


Department of Health and Human Services (HHS)         Completed Actions


Centers for Medicare & Medicaid Services (CMS)



_______________________________________________________________________




1090. NATIONAL STANDARD EMPLOYER IDENTIFIER (CMS-0047-F)

Priority: Economically Significant. Major under 5 USC 801.

CFR Citation: 45 CFR 162

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Rule                      05/03/02                    67 FR 38009

Regulatory Flexibility Analysis Required: Yes

Government Levels Affected: State

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

Agency Contact: Patricia Peyton
Phone: 410 786-1812

RIN: 0938-AI59
_______________________________________________________________________




1091. NON-FEDERAL GOVERNMENTAL PLANS EXEMPT FROM HEALTH INSURANCE 
PORTABILITY REQUIREMENTS (CMS-2033-F)

Priority: Substantive, Nonsignificant

CFR Citation: 45 CFR 146

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              07/26/02                    67 FR 48802

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Dave Holstein
Phone: 410 786-1564

RIN: 0938-AK00
_______________________________________________________________________




1092. SUPPLEMENTARY MEDICAL INSURANCE PREMIUM SURCHARGE AGREEMENTS (CMS-
1221-F)

Priority: Other Significant

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; ...

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    09/27/02                    67 FR 60993

Regulatory Flexibility Analysis Required: No

Government Levels Affected: State, Local

Agency Contact: Sandy Clarke
Phone: 410 786-7451

RIN: 0938-AK42
_______________________________________________________________________




1093. PAYMENT FOR UPGRADED DURABLE MEDICAL EQUIPMENT; WITHDRAWAL OF 
PROPOSED RULE (CMS-1084-WN)

Priority: Info./Admin./Other

CFR Citation: None

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    05/01/02                    67 FR 21617

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: William J. Long
Phone: 410 786-5655
Email: [email protected]

RIN: 0938-AK50
_______________________________________________________________________




1094. PROSPECTIVE PAYMENT SYSTEM FOR LONG-TERM CARE HOSPITALS FOR FY 
2003 (CMS-1177-F)

Priority: Other Significant

CFR Citation: 42 CFR 412

[[Page 74542]]

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Comment Period End              05/21/02
Final Rule                      08/30/02                    67 FR 55954

Regulatory Flexibility Analysis Required: Yes

Government Levels Affected: Local, Federal

Agency Contact: Judith H. Richter
Phone: 410 786-2590

RIN: 0938-AK69
_______________________________________________________________________




1095. REVISIONS TO TRANSACTION AND CODE SET STANDARDS FOR ELECTRONIC 
TRANSACTIONS (CMS-0005-P)

Priority: Other Significant

CFR Citation: 45 CFR 162

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Proposed Rule                   05/31/02                    67 FR 38051
Merged With 0938-AK64           09/12/02

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: State, Local, Tribal, Federal

Agency Contact: Gladys Wheeler
Phone: 410 786-0273

RIN: 0938-AK76
_______________________________________________________________________




1096. MODIFICATIONS TO MANAGED CARE RULES BASED ON PAYMENT PROVISIONS IN 
BIPA AND TECHNICAL CORRECTIONS (CMS-4040-F)

Priority: Economically Significant

CFR Citation: 42 CFR 417; 42 CFR 422

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    03/22/02                    67 FR 13278

Regulatory Flexibility Analysis Required: Yes

Government Levels Affected: None

Agency Contact: Alfred G. D'Alberto
Phone: 410 786-1100

RIN: 0938-AK90
_______________________________________________________________________




1097. HOME HEALTH PROSPECTIVE PAYMENT SYSTEM RATE UPDATE FOR FY 2003 
(CMS-1198-NC)

Priority: Other Significant

CFR Citation: None

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Notice                          06/28/02                    67 FR 43616

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Susan Levy
Phone: 410 786-9364

RIN: 0938-AL16
_______________________________________________________________________




1098. PROSPECTIVE PAYMENT SYSTEM AND CONSOLIDATED BILLING FOR SKILLED 
NURSING FACILITIES--UPDATE FOR FY 2003 (CMS-1202-N)

Priority: Other Significant. Major under 5 USC 801.

CFR Citation: 42 CFR 413.330 to 413.50

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Notice                          07/31/02                    67 FR 49798

Regulatory Flexibility Analysis Required: Yes

Government Levels Affected: None

Agency Contact: William Ullman
Phone: 401 786-5667

RIN: 0938-AL20
_______________________________________________________________________




1099. INPATIENT REHABILITATION FACILITY PROSPECTIVE PAYMENT SYSTEM FOR 
FY 2003 (CMS-1205-N)

Priority: Economically Significant. Major under 5 USC 801.

CFR Citation: 42 CFR 412.600 to 412.632

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Notice                          08/01/02                    67 FR 49928

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Laurence Wilson
Phone: 410 786-4603

RIN: 0938-AL22
_______________________________________________________________________




1100. HOSPITAL INPATIENT PROSPECTIVE PAYMENT SYSTEM FOR FY 2003 (CMS-
1203-F)

Priority: Economically Significant. Major under 5 USC 801.

CFR Citation: 42 CFR 405; 42 CFR 412; 42 CFR 413; 42 CFR 485; 42 CFR 
489

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

NPRM                            05/09/02                    67 FR 31403
Final Action                    08/01/02                    67 FR 49982

Regulatory Flexibility Analysis Required: Yes

Government Levels Affected: None

Agency Contact: Stephen Phillips
Phone: 410 786-4548

RIN: 0938-AL23
_______________________________________________________________________




1101. MEDICARE PROGRAM; MEDICARE-ENDORSED PRESCRIPTION DRUG DISCOUNT 
CARD ASSISTANCE INITIATIVE (CMS-4027-F)

Priority: Economically Significant

CFR Citation: None

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Comment Period End              05/26/02
Final Rule                      09/04/02                    67 FR 56618

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Paula Stannard
Phone: 202 690-7741

Teresa Decaro
Phone: 410 786-6604
Email: [email protected]

RIN: 0938-AL28
_______________________________________________________________________




1102. MEDICARE-ENDORSED PRESCRIPTION DRUG DISCOUNT CARD ASSISTANCE 
INITIATIVE FOR STATE SPONSORS (CMS-4032-P)

Priority: Other Significant

CFR Citation: None

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    03/06/02                    67 FR 10293

Regulatory Flexibility Analysis Required: No

Government Levels Affected: State

Agency Contact: Teresa Decaro
Phone: 410 786-6604
Email: [email protected]

RIN: 0938-AL30

[[Page 74543]]

_______________________________________________________________________




1103. PEER REVIEW ORGANIZATIONS: NAME AND OTHER CHANGES--TECHNICAL 
AMENDMENTS (CMS-3088-FC)

Priority: Other Significant

CFR Citation: 42 CFR 400

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Rule                      05/24/02                    67 FR 36539

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Valerie Mattison-Brown
Phone: 410 786-5958

RIN: 0938-AL38
_______________________________________________________________________




1104. END-STAGE RENAL DISEASE--RESCISSION OF WAIVER OF CONDITIONS FOR 
COVERAGE UNDER A STATE OF EMERGENCY IN HOUSTON, TEXAS AREA (CMS-3074-F2)

Priority: Other Significant

CFR Citation: 42 CFR 405

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Rule                      07/26/02                    67 FR 48800

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Lori Davis
Phone: 410 786-0710

RIN: 0938-AL39
_______________________________________________________________________




1105. PROSPECTIVE PAYMENT SYSTEM FOR INPATIENT REHABILITATION HOSPITAL; 
CORRECTING AMENDMENT (CMS-1069-F2)

Priority: Info./Admin./Other

CFR Citation: 42 CFR 412; 42 CFR 413

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Rule                      07/01/02                    67 FR 44073

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Robert Kuhl
Phone: 410 786-4597

RIN: 0938-AL40
_______________________________________________________________________




1106. HOSPICE WAGE INDEX FOR FY 2003 (CMS-1211-N)

Priority: Routine and Frequent

CFR Citation: None

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Notice                          08/30/02                    67 FR 56092

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Lynn Riley
Phone: 410 786-1286

RIN: 0938-AL41
_______________________________________________________________________




1107. PHYSICIAN FEE SCHEDULE FOR CY 2002: CORRECTION NOTICE (CMS-1169-
CN)

Priority: Info./Admin./Other

CFR Citation: 42 CFR 405; 42 CFR 410; 42 CFR 411; 42 CFR 414; 42 CFR 
415

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Notice                          04/26/02                    67 FR 20681

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Diane Milstead
Phone: 410 786-3355

Related RIN: Related To 0938-AK57
RIN: 0938-AL48
_______________________________________________________________________




1108. NOTICE OF MODIFICATION OF BENEFICIARY ASSESSMENT REQUIREMENTS FOR 
SKILLED NURSING FACILITIES (CMS-1209-N)

Priority: Info./Admin./Other

CFR Citation: None

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Notice                          05/31/02                    67 FR 38128

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Dana Burley
Phone: 410 786-4547

RIN: 0938-AL55
_______________________________________________________________________




1109. REVISION OF THE PROCEDURES FOR REQUESTING EXCEPTIONS TO COST 
LIMITS FOR SKILLED NURSING FACILITIES AND ELIMINATION OF 
RECLASSIFICATIONS; CORRECTION (CMS-1883-F3)

Priority: Info./Admin./Other

CFR Citation: 42 CFR 413.30(d)

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Rule                      07/26/02                    67 FR 48801

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Julie Stankivic
Phone: 410 786-5725

RIN: 0938-AL61
_______________________________________________________________________




1110. NOTICE OF INTENT TO CONDUCT NEGOTIATED RULEMAKING FOR SPECIAL 
PAYMENT PROVISIONS AND STANDARDS FOR SUPPLIERS OF CUSTOM-FABRICATED 
ORTHOTICS AND PROSTHETICS (CMS-6012-N)

Priority: Substantive, Nonsignificant

CFR Citation: None

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Notice                          03/22/02                    67 FR 13297

Regulatory Flexibility Analysis Required: Yes

Government Levels Affected: None

Agency Contact: Kathryn S Cox
Phone: 410 786-5954

RIN: 0938-AL68
_______________________________________________________________________




1111. MEDICAID MANAGED CARE: WITHDRAWAL (CMS-2001-F4)

Priority: Other Significant

CFR Citation: None

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Rule                      06/14/02                    67 FR 40988

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Bruce Johnson
Phone: 410 786-0615

RIN: 0938-AL83

[[Page 74544]]

_______________________________________________________________________




1112. FY 1999 SCHIP REALLOCATION NOTICE (CMS-2137-N)

Priority: Substantive, Nonsignificant

CFR Citation: None

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Notice                          04/26/02                    67 FR 20794

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Richard Strauss
Phone: 410 786-2019
Email: [email protected]

RIN: 0938-AL86
_______________________________________________________________________




1113. [bull] CRITERIA FOR ACCEPTANCE OF SUPPLEMENTAL PRACTICE EXPENSE 
SURVEY DATA (CMS-1223-IFC)

Priority: Other Significant

Legal Authority: Social Security Act, sec 1102; Social Security Act, 
sec 1871; Social Security Act, sec 1881(b); 42 USC 1302; 42 USC 
1395(hh); 42 USC 1395rr(b)(1)

CFR Citation: 42 CFR 414

Legal Deadline: None

Abstract: This interim final rule with comment period modifies the 
criteria for physicians and non-physicians specialty groups for 
submitting supplemental practice expense survey data for use in 
determining payments under the physician fee schedule.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              06/28/02                    67 FR 43555
Interim Final Rule Effective    06/28/02

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Marc Hartstein, Center for Health Plans and Providers, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, 7500 Security Boulevard, Baltimore, MD 21244-1850
Phone: 410 786-4539

Related RIN: Related To 0938-AL21
RIN: 0938-AL99

_______________________________________________________________________


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


Administration for Children and Families (ACF)



_______________________________________________________________________




1114. SAFEGUARDING CHILD SUPPORT AND EXPANDED FPLS INFORMATION

Priority: Substantive, Nonsignificant

Legal Authority: 42 USC 652 to 654A; 42 USC 663

CFR Citation: 45 CFR 303.3; 45 CFR 303.21; 45 CFR 303.70

Legal Deadline: None

Abstract: The Personal Responsibility and Work Opportunity 
Reconciliation Act of 1996 made far-reaching amendments to title IV-D 
of the Social Security Act, which governs the child support enforcement 
program. The Balanced Budget Act of 1997, the Adoption and Safe 
Families Act of 1997 and the Child Support Performance and Incentive 
Act of 1998 further amended title IV-D. A significant result of this 
legislation is an expansion in the scope of information available to 
State IV-D child support enforcement agencies. The legislation has 
rendered obsolete or inconsistent several regulations at 45 CFR chapter 
III, Office of Child Support Enforcement, including the regulations on 
the Federal Parent Locator Service, the State Parent Locator Services, 
offset of Federal payments for purposes of collecting child support, 
and safeguarding of information. This regulation would update various 
sections in 45 CFR chapter III to reflect the statutory changes.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            03/00/03

Regulatory Flexibility Analysis Required: No

Government Levels Affected: State, Local, Tribal

Agency Contact: Eileen C. Brooks, Deputy Director, Policy Division, 
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
TDD Phone: 800 877-8339
Fax: 202 401-4054
Email: [email protected]

RIN: 0970-AC01
_______________________________________________________________________




1115. 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.

Abstract: A notice of proposed rulemaking will be published in the 
Federal Register 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                            03/00/03

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
_______________________________________________________________________




1116. [bull] CHILD SUPPORT ENFORCEMENT PROGRAM; CUSTOMER SERVICE ANNUAL 
STATE SELF-ASSESSMENT

Priority: Substantive, Nonsignificant

Legal Authority: 42 USC 1302; 42 USC 654(15)(A)

CFR Citation: 45 CFR 308.2; 45 CFR 308.3

[[Page 74545]]

Legal Deadline: None

Abstract: This proposed rule will revise existing regulations on State 
child support self-assessments to add customer service as one of the 
required program compliance criteria.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/00/03

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: State

URL For Public Comments:
http://www.acf.hhs.gov/hypernews/

Agency Contact: Annie Miller, Program Specialist, Policy Division, 
Department of Health and Human Services, Administration for Children 
and Families, 4th Floor East, Office of Child Support Enforcement, 370 
L'Enfant Promenade SW., Washington, DC 20447
Phone: 202 401-1467
TDD Phone: 800 877-8339
Fax: 202 401-4054
Email: [email protected]

RIN: 0970-AC10
_______________________________________________________________________




1117. [bull] CHILD SUPPORT ENFORCEMENT PROGRAM; EXPENDITURES FOR 
CASEWORKER COSTS

Priority: Substantive, Nonsignificant

Legal Authority: 42 USC 1302; 42 USC 655

CFR Citation: 45 CFR 304.23

Legal Deadline: None

Abstract: This proposed rule will revise existing regulations on 
expenditures for which Federal Financial Participation is available 
under the Child Support Enforcement program. Under the current 
regulations, Federal Financial Participation is not available in any 
costs of caseworkers who are also performing the assistance payments or 
social services functions under title IV-A (TANF) or title XX (Social 
Services Block Grants) of the Social Security Act. This proposed 
regulation will remove the prohibition to reflect current business 
practices of the Department of Health and Human Services under which 
costs are allocated to the benefiting program.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/00/03

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: State

URL For Public Comments:
http://www.acf.hhs.gov/hypernews/

Agency Contact: Sheck Chin, Special Assistant to the Division Director, 
Department of Health and Human Services, Administration for Children 
and Families, 4th Floor East, 370 L'Enfant Promenade SW., Washington, 
DC 20447
Phone: 202 260-5830
TDD Phone: 800 877-8339
Fax: 202 401-4054
Email: [email protected]

RIN: 0970-AC11
_______________________________________________________________________


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


Administration for Children and Families (ACF)



_______________________________________________________________________




1118. 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                    12/00/02

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
_______________________________________________________________________




1119. 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
Final Action                    06/00/03

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
_______________________________________________________________________




1120. 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

[[Page 74546]]

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                    03/00/03

Regulatory Flexibility Analysis Required: No

Government Levels Affected: State

Agency Contact: Eileen C. Brooks, Deputy Director, Policy Division, 
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
TDD Phone: 800 877-8339
Fax: 202 401-4054
Email: [email protected]

RIN: 0970-AB81
_______________________________________________________________________




1121. 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                    12/00/03

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
_______________________________________________________________________




1122. 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 1305; 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              03/00/03

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
_______________________________________________________________________




1123. [bull] CHILD SUPPORT ENFORCEMENT PROGRAM; FEDERAL TAX REFUND 
OFFSET

Priority: Substantive, Nonsignificant

Legal Authority: 42 USC 1302

CFR Citation: 45 CFR 303.72

Legal Deadline: None

Abstract: This interim final rule will revise existing regulations on 
collecting child support arrears through the Federal Tax Refund Offset 
process. The revisions are needed to reflect changes in data processing 
protocols with the Department of the Treasury. We are also updating the 
regulation to reflect current business practices and requests from the 
state child support agencies.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              03/00/03

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: State

URL For Public Comments:
http://www.acf.hhs.gov/hypernews/

Agency Contact: Eileen C. Brooks, Deputy Director, Policy Division, 
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
TDD Phone: 800 877-8339
Fax: 202 401-4054
Email: [email protected]

RIN: 0970-AC09
_______________________________________________________________________


Department of Health and Human Services (HHS)         Completed Actions


Administration for Children and Families (ACF)



_______________________________________________________________________




1124. PROGRAM PERFORMANCE STANDARDS FOR THE OPERATION OF HEAD START 
PROGRAMS

Priority: Other Significant

CFR Citation: 45 CFR 1304

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn                       08/30/02

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Douglas Klafehn
Phone: 202 205-8569
Email: [email protected]

RIN: 0970-AB99


[[Page 74547]]

_______________________________________________________________________


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


Administration on Aging (AOA)



_______________________________________________________________________




1125. 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; 45 CFR 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 winter of 2002-03.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            01/00/03

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, Deputy Assistant Secretary for Policy and 
Programs, 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
[FR Doc. 02-25451 Filed 12-06-02; 8:45 am]
BILLING CODE 4150-24-S
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