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


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Part VIII





Department of Health and Human Services





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Semiannual Regulatory Agenda

[[Page 72862]]



DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)






_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Office of the Secretary

21 CFR Ch. I

42 CFR Chs. I-V

45 CFR Subtitle A; Subtitle B, Chs. II, III, and XIII

Regulatory Agenda

AGENCY: Office of the Secretary, HHS.

ACTION: Semiannual agenda.

_______________________________________________________________________

SUMMARY: The Regulatory Flexibility Act of 1980 and Executive Order 
12866 require the semiannual publication of an inventory of all 
rulemaking actions under development or review, known as the regulatory 
agenda. 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. 
Citizens 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 a notice of proposed rulemaking, or a final 
rule within the next 12 months. Also included in the Long-Term Action 
sections below are summaries of actions that are under development, but 
which we will probably not complete within the next 12 months.

     We welcome hearing the views of all concerned with regard to 
these planned regulatory or deregulatory actions. Comments may be 
directed to the agency officials cited in each of the summaries. 
Or, if early attention at the Secretary's level is seen as 
warranted, comments should be sent 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 issues across the 
executive branch. The HHS portion of the Plan appears in part II of 
this issue of the Federal Register with those of other Departments 
and Agencies. Our Plan entries are included in the table of 
contents below, denoted by a bracketed bold reference to the 
appropriate sequence number in part II.

Dated: October 17, 2003.

 Ann C. Agnew,

Executive Secretary to the Department.

                                  Office of the Secretary--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
961         Safe Harbor for Arrangements Involving Federally Qualified Health Centers...........     0991-AB06
962         Claims Collection...................................................................     0991-AB18
963         Salary Offset.......................................................................     0991-AB19
964         Health Insurance Portability and Accountability Act-Enforcement (Reg Plan Seq No.        0991-AB29
            40).................................................................................
----------------------------------------------------------------------------------------------------------------
References in boldface appear in the Regulatory Plan in part II of this issue of the Federal Register.


                                    Office of the Secretary--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
965         Shared Risk Exception to the Safe Harbor Provisions.................................     0991-AA91
966         Safe Harbor for Waiver of Beneficiary Coinsurance and Deductible Amounts for a           0991-AB16
            Medicare SELECT Policy..............................................................
967         Tax Refund Offset...................................................................     0991-AB17
968         Implementation of the Equal Access to Justice Act in Agency Proceedings.............     0991-AB22
969         Clarification of Terms and Application of Program Exclusion Authority for Submitting     0991-AB23
            Claims Containing Excessive Charges.................................................
----------------------------------------------------------------------------------------------------------------


                                   Office of the Secretary--Long-term Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
970         Revisions to Regulations Addressing the OIG's Authority to Impose Civil Money            0991-AB03
            Penalties and Assessments...........................................................
971         Amending the Regulations Governing Nondiscrimination on the Basis of Race, Color,        0991-AB10
            National Origin, Handicap, Sex, and Age To Conform to the Civil Rights Restoration
            Act of 1987.........................................................................
----------------------------------------------------------------------------------------------------------------


[[Page 72863]]


                                   Office of the Secretary--Completed Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
972         Governmentwide Debarment and Suspension (Nonprocurement) and Governmentwide              0991-AB12
            Requirements for Drug-Free Workplace (Grants).......................................
----------------------------------------------------------------------------------------------------------------


                 Substance Abuse and Mental Health Services Administration--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
973         Requirements Governing the Use of Seclusion and Restraint in Certain Nonmedical          0930-AA10
            Community-Based Facilities for Children and Youth (Reg Plan Seq No. 41).............
974         Mandatory Guidelines for the Federal Workplace Drug Testing Program.................     0930-AA12
----------------------------------------------------------------------------------------------------------------
References in boldface appear in the Regulatory Plan in part II of this issue of the Federal Register.


                   Substance Abuse and Mental Health Services Administration--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
975         Substance Abuse and Mental Health Services Administration (SAMHSA) Charitable Choice     0930-AA11
----------------------------------------------------------------------------------------------------------------


                         Centers for Disease Control and Prevention--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
976         Amendments to Quality Assurance and Administrative Provision for Approval of             0920-AA04
            Respiratory Protective Devices......................................................
----------------------------------------------------------------------------------------------------------------


                          Centers for Disease Control and Prevention--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
977         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......
----------------------------------------------------------------------------------------------------------------


                                   Food and Drug Administration--Prerule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
978         Over-the-Counter (OTC) Drug Review..................................................     0910-AA01
979         Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Human Food     0910-AC58
            (Part 110) (Section 610 Review).....................................................
980         Health Claims.......................................................................     0910-AF09
981         Prescription Drug Marketing Act of 1987; Prescription Drug Amendments of 1992;           0910-AF16
            Policies, Requirements, and Administrative Procedures; Derivatives of Blood.........
----------------------------------------------------------------------------------------------------------------


                                Food and Drug Administration--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
982         Foreign and Domestic Establishment Registration and Listing Requirements for Drugs       0910-AA49
            and Biologics.......................................................................

[[Page 72864]]

 
983         Blood Initiative....................................................................     0910-AB26
984         Applications for FDA Approval To Market a New Drug; Complete Response Letter;            0910-AB34
            Amendments To Unapproved Applications...............................................
985         Current Good Manufacturing Practice for Medicated Feeds.............................     0910-AB70
986         Requirements Pertaining to Sampling Services and Private Laboratories Used in            0910-AB96
            Connection With Imported Food.......................................................
987         Prevention of Salmonella Enteritidis in Shell Eggs (Reg Plan Seq No. 42)............     0910-AC14
988         Institutional Review Boards: Registration Requirements..............................     0910-AC17
989         Use of Materials Derived From Bovine and Ovine Animals in FDA-Regulated Products....     0910-AC19
990         Chronic Wasting Disease: Control of Food Products and Cosmetics Derived From Exposed     0910-AC21
            Animal Populations..................................................................
991         Exception From General Requirements for Informed Consent; Request for Comments and       0910-AC25
            Information (Reg Plan Seq No. 43)...................................................
992         Medical Devices; Anesthesiology Devices; Proposed Reclassification of Pressure           0910-AC30
            Regulators for Use With Medical Oxygen..............................................
993         Toll-Free Number for Reporting Adverse Events on Labeling for Human Drugs (Reg Plan      0910-AC35
            Seq No. 44).........................................................................
994         Food Labeling: Trans Fatty Acids in Nutrition Labeling: Consumer Research To             0910-AC50
            Consider Nutrient Content and Health Claims and Possible Footnote or Disclosure
            Statements..........................................................................
995         Submission of Standardized Electronic Study Data From Clinical Studies Evaluating        0910-AC52
            Human Drugs and Biologics...........................................................
996         Medical Gas Containers and Closures; Current Good Manufacturing Practice                 0910-AC53
            Requirements........................................................................
997         Food Standards: General Principles and Food Standards Modernization.................     0910-AC54
998         Positron Emission Tomography Drugs; Current Good Manufacturing Practices............     0910-AC55
999         Revision of the Requirements for Spore-Forming Microorganisms.......................     0910-AC57
1000        Reporting Information Regarding Falsification of Data...............................     0910-AC59
1001        Definition of ``Serious Adverse Health Consequences'' Under the Public Health            0910-AF06
            Security and Bioterrorism Preparedness and Response Act of 2002 (Reg Plan Seq No.
            45).................................................................................
1002        Quality Standard Regulation Establishing Allowable Level for Arsenic in Bottled          0910-AF10
            Water...............................................................................
1003        Content and Format of Labeling for Human Prescription Drugs and Biologics;               0910-AF11
            Requirements for Pregnancy and Lactation............................................
1004        Cochineal Extract and Carmine Label Declaration.....................................     0910-AF12
1005        Charging for Investigational Drugs..................................................     0910-AF13
1006        Treatment Use of Investigational Drugs..............................................     0910-AF14
1007        Human Subject Protection; Foreign Clinical Studies Not Conducted Under an                0910-AF15
            Investigational New Drug Application................................................
1008        Use of Ozone-Depleting Substances: Removal of Essential Use Designation; Albuterol       0910-AF18
            (Reg Plan Seq No. 46)...............................................................
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
1009        Infant Formula: Requirements Pertaining to Good Manufacturing Practice, Quality          0910-AA04
            Control Procedures, Quality Factors, Notification Requirements, and Records and
            Reports.............................................................................
1010        Investigational New Drugs: Export Requirements for Unapproved New Drug Products.....     0910-AA61
1011        Determination That Informed Consent Is Infeasible or Is Contrary to the Best             0910-AA89
            Interest of Recipients..............................................................
1012        Labeling for Human Prescription Drugs; Revised Format (Reg Plan Seq No. 47).........     0910-AA94
1013        Safety Reporting Requirements for Human Drug and Biological Products (Reg Plan Seq       0910-AA97
            No. 48).............................................................................
1014        Supplements and Other Changes to an Approved Application............................     0910-AB61
1015        CGMP for Blood and Blood Components: Notification of Consignees and Transfusion          0910-AB76
            Recipients Receiving Blood and Blood Components at Increased Risk of Transmitting
            HCV Infection (Lookback) (Reg Plan Seq No. 49)......................................
1016        Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Dietary        0910-AB88
            Ingredients and Dietary Supplements (Reg Plan Seq No. 50)...........................
1017        Requirements for Submission of Labeling for Human Prescription Drugs and Biologics       0910-AB91
            in Electronic Format................................................................
1018        Additional Safeguards for Children in Clinical Investigations of FDA-Regulated           0910-AC07
            Products............................................................................
1019        Bar Code Label Requirements for Human Drug Products and Blood (Reg Plan Seq No. 51).     0910-AC26
1020        Medical Devices; Patient Examination and Surgeons' Gloves; Adulteration.............     0910-AC32
1021        Amendments to the Performance Standard for Diagnostic X-Ray Systems and Their Major      0910-AC34
            Components..........................................................................
1022        Administrative Detention of Food for Human or Animal Consumption Under the Public        0910-AC38
            Health Security and Bioterrorism Preparedness and Response Act of 2002 (Reg Plan Seq
            No. 52).............................................................................

[[Page 72865]]

 
1023        Establishment and Maintenance of Records Pursuant to the Public Health Security and      0910-AC39
            Bioterrorism Preparedness and Response Act of 2002 (Reg Plan Seq No. 53)............
1024        Registration of Food and Animal Feed Facilities.....................................     0910-AC40
1025        Prior Notice of Imported Food Under the Public Health Security and Bioterrorism          0910-AC41
            Preparedness and Response Act of 2002...............................................
1026        Requirements for Liquid Medicated Feed and Free-Choice Medicated Feed...............     0910-AC43
1027        Presubmission Conferences...........................................................     0910-AC44
1028        Biological Products; Bacterial Vaccines and Toxoids; Implementation of Efficacy          0910-AC56
            Review..............................................................................
1029        Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or            0910-AF08
            Holding of Drugs; Revision of Certain Labeling Controls.............................
----------------------------------------------------------------------------------------------------------------
References in boldface appear in the Regulatory Plan in part II of this issue of the Federal Register.


                                 Food and Drug Administration--Long-term Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
1030        Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and           0910-AB27
            Tissue-Based Products...............................................................
1031        Current Good Tissue Practice for Human Cell, Tissue, and Cellular and Tissue-Based       0910-AB28
            Products Establishments; Inspection and Enforcement.................................
1032        Requirements for Submission of In Vivo Bioequivalence Data..........................     0910-AC23
1033        Food Labeling: Food Allergen Ingredient Labeling....................................     0910-AF07
----------------------------------------------------------------------------------------------------------------


                                 Food and Drug Administration--Completed Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
1034        Investigational Use New Animal Drug Regulations (Completion of a Section 610 Review)     0910-AB02
1035        Food Labeling: Trans Fatty Acids in Nutrition Labeling, Nutrient Content Claims, and     0910-AB66
            Health Claims.......................................................................
1036        Aluminum in Large- and Small-Volume Parenterals Used in Total Parenteral Nutrition..     0910-AC18
1037        Regulation of Carcinogenic Compounds Used in Food-Producing Animals; Definition of       0910-AC45
            ``No Residue''......................................................................
1038        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......
----------------------------------------------------------------------------------------------------------------


                        Health Resources and Services Administration--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
1039        National Practitioner Data Bank for Adverse Information on Physicians and Other          0906-AA41
            Health Care Practitioners: Medical Malpractice Payments Reporting Requirements......
1040        Designation of Medically Underserved Populations and Health Professional Shortage        0906-AA44
            Areas...............................................................................
----------------------------------------------------------------------------------------------------------------


                         Health Resources and Services Administration--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
1041        Interim Final Rule for the Smallpox Emergency Personnel Protection Program: Smallpox     0906-AA60
            (Vaccinia) Vaccine Injury Table.....................................................
1042        Smallpox Vaccine Injury Compensation Program: Administrative Implementation (Reg         0906-AA61
            Plan Seq No. 54)....................................................................
----------------------------------------------------------------------------------------------------------------
References in boldface appear in the Regulatory Plan in part II of this issue of the Federal Register.


[[Page 72866]]


                         Health Resources and Services Administration--Long-term Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
1043        National Practitioner Data Bank for Adverse Information on Physicians and Other          0906-AA57
            Health Care Practitioners: Reporting Adverse and Negative Actions...................
----------------------------------------------------------------------------------------------------------------


                                    Indian Health Service--Completed Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
1044        Indian Child Protection and Family Violence Prevention Act Minimum Standards of          0917-AA02
            Character...........................................................................
----------------------------------------------------------------------------------------------------------------


                               National Institutes of Health--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
1045        Undergraduate Scholarship Program Regarding Professions Needed by the National           0925-AA10
            Institutes of Health (NIH)..........................................................
1046        National Institutes of Health Training Grants.......................................     0925-AA28
1047        Standards for a National Chimpanzee Sanctuary System................................     0925-AA31
1048        National Institutes of Health AIDS Research Loan Repayment Program..................     0925-AA32
1049        National Institutes of Health Extramural Loan Repayment Program for Clinical             0925-AA33
            Researchers.........................................................................
1050        National Institutes of Health Pediatric Research Loan Repayment Program.............     0925-AA34
1051        National Institutes of Health Loan Repayment Program for Health Disparities Research     0925-AA35
1052        National Institutes of Health Clinical Research Loan Repayment Program for               0925-AA36
            Individuals From Disadvantaged Backgrounds..........................................
1053        National Institute of Child Health and Human Development Contraception and               0925-AA41
            Infertility Research Loan Repayment Program.........................................
----------------------------------------------------------------------------------------------------------------


                                 National Institutes of Health--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
1054        National Institutes of Health Loan Repayment Program for Research Generally.........     0925-AA18
1055        Scientific Peer Review of Research Grant Applications and Research and Development       0925-AA20
            Contract Projects...................................................................
1056        National Institutes of Health Center Grants.........................................     0925-AA24
----------------------------------------------------------------------------------------------------------------


                            Office of Public Health and Science--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
1057        Public Health Service Policies on Research Misconduct...............................     0940-AA04
1058        Human Subjects Protection Regulations: Institutional Review Boards Registration          0940-AA06
            Requirements........................................................................
1059        Human Subjects Protection Regulations: Training and Education Requirements for           0940-AA08
            Institutional Officials, Institutional Review Board Members and Staff, Human
            Protections Administrators, and Investigator........................................
----------------------------------------------------------------------------------------------------------------


                              Office of Public Health and Science--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
1060        Public Health Service Standards for the Protection of Research Misconduct                0940-AA01
            Whistleblowers......................................................................
----------------------------------------------------------------------------------------------------------------


[[Page 72867]]


                          Centers for Medicare & Medicaid Services--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
1061        End Stage Renal Disease (ESRD) Conditions for Coverage (CMS-3818-P) (Section 610         0938-AG82
            Review) (Reg Plan Seq No. 55).......................................................
1062        Hospital Conditions of Participation: Requirements for Approval and Reapproval of        0938-AH17
            Transplant Centers To Perform Organ Transplants (CMS-3835-P) (Reg Plan Seq No. 56)..
1063        Hospice Care--Conditions of Participation (CMS-3844-P)..............................     0938-AH27
1064        Supplier Standards for Home Oxygen, Therapeutic Shoes, and Home Nutrition Therapy        0938-AJ98
            (CMS-6010-P)........................................................................
1065        Health Insurance Reform: Claims Attachments Standards (CMS-0050-P)..................     0938-AK62
1066        Organ Procurement Organization Conditions for Coverage (CMS-3064-P) (Reg Plan Seq        0938-AK81
            No. 57).............................................................................
1067        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. 58).......
1068        Prospective Payment System for Inpatient Psychiatric Facilities FY 2004 (CMS-1213-F)     0938-AL50
            (Reg Plan Seq No. 59)...............................................................
1069        Provider Reimbursement Determinations and Appeals (CMS-1727-P)......................     0938-AL54
1070        Health Coverage Portability's Request for Information on Benefit-Specific Waiting        0938-AL64
            Periods (CMS-2150-NC)...............................................................
1071        DMERC Service Areas and Related Matters (CMS-1219-P)................................     0938-AL76
1072        Revisions to Conditions for Coverage for Ambulatory Surgical Centers (CMS-3887-P)...     0938-AL80
1073        Health Coverage Portability: Tolling Certain Time Periods and Interactions With          0938-AL88
            Family and Medical Leave Act (CMS-2158-P)...........................................
1074        Criteria for Determining Whether a Drug is Considered Usually Self-Administered (CMS-    0938-AM13
            1228-P).............................................................................
1075        Procedures for Maintaining Code Lists in the Negotiated National Coverage                0938-AM36
            Determinations for Clinical Diagnostic Laboratory Services (CMS-3119-PN)............
1076        Hospital Patients' Rights CoP--Standard Safety Compliance Committees (CMS-3120-P)        0938-AM39
            (Reg Plan Seq No. 60)...............................................................
1077        Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities--     0938-AM46
            Update for FY 2005 (CMS-1249-N).....................................................
1078        Modifications to Electronic Transactions and Code Sets (CMS-0009-P).................     0938-AM50
1079        Revised Civil Money Penalties, Assessments, Exclusions, and Related Appeals              0938-AM54
            Procedures (CMS-6146-P).............................................................
1080        Requirements for Nursing Homes To Identify the Number of Licensed and Unlicensed         0938-AM55
            Nurses (CMS-3121-P).................................................................
1081        Changes to the Hospital Outpatient Prospective System and Calendar Year 2005 Payment     0938-AM75
            Rates (CMS-1427-P)..................................................................
1082        Changes to the Hospital Inpatient Prospective Payment System and FY 2005 Rates (CMS-     0938-AM80
            1428-P).............................................................................
1083        Covered Outpatient Drugs Under the Medicaid Drug Rebate Program (CMS-2174-P)........     0938-AM81
1084        Prospective Payment System for Inpatient Rehabilitation Facilities for FY 2005 (CMS-     0938-AM82
            1360-P).............................................................................
1085        Prospective Payment System for Long-Term Care Hospitals: Annual Payment Rate Updates     0938-AM84
            and Policy Changes (Effective 7/1/04) (CMS-1263-P)..................................
1086        Payment Error Rate Measurement (PERM) Program (CMS-2186-P)..........................     0938-AM86
1087        Requirements for Long-Term Care Facilities: Hospice Services (CMS-3140-P)...........     0938-AM87
1088        Revisions to Payment Policies Under the Physician Fee Schedule for Calendar Year         0938-AM90
            2005 (CMS-1429-P)...................................................................
1089        Home Health Prospective Payment System Rate Update FY 2005 (CMS-1265-P).............     0938-AM93
1090        Revisions to Cost Sharing Regulations (CMS-2144-P)..................................     0938-AM94
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
1091        Home Health Agency (HHA) Conditions of Participation (CoPs) (CMS-3819-FC)...........     0938-AG81
1092        Requirements for Establishing and Maintaining Medicare Billing Privileges (CMS-6002-     0938-AH73
            F)..................................................................................
1093        Health Insurance Reform: Standard Unique Health Care Provider Identifier (CMS-0045-      0938-AH99
            F)..................................................................................
1094        Appeals of Carrier Determination That a Supplier Fails To Meet the Requirements for      0938-AI49
            Medicare Billing Privileges (CMS-6003-F)............................................
1095        Coverage of Religious Nonmedical Health Care Institutions (CMS-1909-F)..............     0938-AI93
1096        Medicare Outcome and Assessment Information Set (OASIS) Data Reporting Requirements      0938-AJ10
            (CMS-3006-F)........................................................................
1097        Rural Health Clinics: Amendments to Participation Requirements and Payment               0938-AJ17
            Provisions and Establishment of a Quality Assessment and Improvement Program (CMS-
            1910-F).............................................................................
1098        Hospital Conditions of Participation: Laboratory Services (CMS-3014-F)..............     0938-AJ29
1099        Medicare Hospice Care Amendments (CMS-1022-F).......................................     0938-AJ36
1100        Use of Restraint and Seclusion in Residential Treatment Facilities Providing             0938-AJ96
            Inpatient Psychiatric Services to Individuals Under Age 21 (CMS-2065-F) (Reg Plan
            Seq No. 61).........................................................................
1101        All Provider Bad Debt Payment (CMS-1126-F)..........................................     0938-AK02

[[Page 72868]]

 
1102        Review of National Coverage Determinations and Local Coverage Determinations (CMS-       0938-AK60
            3063-F).............................................................................
1103        Physicians' Referrals to Health Care Entities With Which They Have Financial             0938-AK67
            Relationships--Phase II (CMS-1810-FC)...............................................
1104        Rate of Reimbursement of Photocopy Expenses for Quality Improvement Organizations        0938-AK68
            (CMS-3055-F)........................................................................
1105        Elimination of Statement of Intent Procedures for Filing Medicare Claims (CMS-1185-      0938-AK79
            F)..................................................................................
1106        Extending Medicare Entitlement When Disability Benefit Entitlement Ends Because of       0938-AK94
            Substantial Gainful Activity (CMS-4018-F)...........................................
1107        Medicare Program; Interest Calculation (CMS-6014-F).................................     0938-AL14
1108        Health Coverage Portability for Group Health Plans and Group Health Insurance            0938-AL43
            Issuers (CMS-2151-F)................................................................
1109        Permitting Premium Reductions as Additional Benefits Under Medicare+Choice Plans         0938-AL49
            (CMS-6016-F)........................................................................
1110        Revisions to the Medicare Appeals Process (CMS-4004-FC) (Reg Plan Seq No. 62).......     0938-AL67
1111        Changes to the Hospital Outpatient Prospective Payment System and Calendar Year 2004     0938-AL91
            Payment Rates (CMS-1471-F)..........................................................
1112        Electronic Medicare Claims Submission (CMS-0008-F)..................................     0938-AM22
1113        Inpatient Hospital Deductible and Hospital and Extended Care Services Coinsurance        0938-AM31
            Amounts for Calendar Year 2004 (CMS-8016-N).........................................
1114        Monthly Actuarial Rates and Monthly Supplementary Medical Insurance Premium Rate         0938-AM32
            Beginning January 1, 2004 (CMS-8017-N)..............................................
1115        Part A Premiums for Calendar Year 2004 for the Uninsured Aged and for Certain            0938-AM33
            Disabled Individuals Who Have Exhausted Other Entitlement (CMS-8018-N)..............
1116        Grants to States for Operation of Qualified High Risk Pools (CMS-2179-F)............     0938-AM42
1117        Fee Schedule for Payment of Ambulance Services Update for Calendar Year 2004 (CMS-       0938-AM44
            1232-FC)............................................................................
1118        Non-Federal Governmental Plans Exempt From HIPAA Title I Requirements (CMS-2033-F)..     0938-AM71
1119        Revisions to the Appeals Process for Initial Claim Determinations (CMS-4064-F) (Reg      0938-AM73
            Plan Seq No. 63)....................................................................
1120        More Flexible Requirements for Powered-Operated Vehicles (CMS-3017-FC)..............     0938-AM74
1121        Hospice Wage Index FY 2005 (CMS-1264-N).............................................     0938-AM78
1122        Ticket to Work: Defining Individuals with Potentially Severe Disabilities (CMS-2172-     0938-AM79
            N)..................................................................................
1123        Hospital Conditions of Participation: Requirements For History and Physical              0938-AM88
            Examinations; Authentication of Verbal Orders, Securing Medications and Post-
            Anesthesia Evaluations (CMS-3122-F).................................................
1124        Disproportionate Share Hospital (DSH) Payments Institutions for Mental Disease           0938-AM89
            (IMDs) (CMS-2062-N).................................................................
----------------------------------------------------------------------------------------------------------------
References in boldface appear in the Regulatory Plan in part II of this issue of the Federal Register.


                           Centers for Medicare & Medicaid Services--Long-term Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
1125        Standard Unique National Health Plan Identifiers (CMS-6017-P).......................     0938-AH87
1126        Exclusion of Medicare Benefits for Aliens Not Lawfully Present in the United States      0938-AM47
            (CMS-1222-FC).......................................................................
1127        Changes to the Criteria for Being Classified as an Inpatient Rehabilitation Facility     0938-AM72
            (CMS-1262-F)........................................................................
----------------------------------------------------------------------------------------------------------------


                           Centers for Medicare & Medicaid Services--Completed Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
1128        Conditions of Participation of Intermediate Care Facilities for Persons With Mental      0938-AK23
            Retardation (CMS-3046-P)............................................................
1129        Laboratory Requirements Relating to Quality Systems and Certain Personnel                0938-AK24
            Qualifications (CMS-2226-CN)........................................................
1130        Fire Safety Requirements for Certain Health Care Facilities (CMS-3047-F)............     0938-AK35
1131        Hospital Conditions of Participation: Quality Assessment and Performance                 0938-AK40
            Improvements (QAPI) (CMS-3050-F)....................................................
1132        Revised Process for Making Medicare National Coverage Determinations (CMS-3062-N)...     0938-AK61
1133        Modifications to Medicare Managed Care Rules (CMS-4041-F)...........................     0938-AK71
1134        Inpatient Disproportionate Share Hospital (DSH) Adjustment: Calculation of Medicaid      0938-AK77
            Patient and Total Patient Days in the Medicare DSH Adjustment (CMS-1171-P)..........
1135        Modifications to the State Children's Health Insurance Program (SCHIP) (CMS-2006-F).     0938-AL00
1136        Requirements for Paid Feeding Assistants in Long-Term Care Facilities (CMS-2131-F)..     0938-AL18

[[Page 72869]]

 
1137        Changes to the Hospital Outpatient Prospective Payment System and Calendar Year 2003     0938-AL19
            Payment Rates; Changes to Payment Suspension for Unfiled Cost Reports; Correction to
            Final Rule (CMS-1206-CN2)...........................................................
1138        Payment for Respiratory Assist Devices With Bi-Level Capability and a Back-Up Rate       0938-AL27
            (CMS-1167-F)........................................................................
1139        Interim Final Amendment for Mental Health Parity (CMS-2152-IFC).....................     0938-AL44
1140        Electronic Submission of Cost Reports (CMS-1199-F)..................................     0938-AL51
1141        Exclusions from the Definition of ``Optional Targeted Low-Income Child'' and             0938-AL62
            Purchase of Family Coverage--Benefit Flexibility in Parent Coverage (CMS-2148-P)....
1142        State Allotments for Payment of Medicare Part B Premiums for Qualifying Individuals;     0938-AL79
            Federal FY 2002 (CMS-2136-FN).......................................................
1143        Medicaid Coverage Rules for Inmates of Public Institutions (CMS-2077-P).............     0938-AL85
1144        Targeted Case Management (CMS-2061-P)...............................................     0938-AL87
1145        Changes to the Hospital Inpatient Prospective Payment System and FY 2004 Rates (CMS-     0938-AL89
            1470-F).............................................................................
1146        Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities--     0938-AL90
            Update for FY 2004 (CMS-1469-F).....................................................
1147        Prospective Payment System for Long-Term Care Hospitals for FY 2004 (CMS-1472-P)....     0938-AL92
1148        Home Health Prospective Payment System Rate Update for FY 2004 (CMS-1473-NC)........     0938-AL94
1149        Prospective Payment System for Inpatient Rehabilitation Hospitals for FY 2004 (CMS-      0938-AL95
            1474-F).............................................................................
1150        Revisions to Payment Policies Under the Physician Fee Schedule for Calendar Year         0938-AL96
            2004 (CMS-1476-P)...................................................................
1151        Nondiscrimination In Post-Hospital Referral to Home Health Agencies and Other            0938-AM01
            Entities (CMS-1224-F)...............................................................
1152        Update of the List of Covered Procedures for Ambulatory Surgical Centers (CMS-1885-      0938-AM02
            FC).................................................................................
1153        Medicaid Home and Community Based Services Waivers (CMS-2162-P).....................     0938-AM05
1154        Payment Reform for Part B Drugs (CMS-1229-F)........................................     0938-AM12
1155        Nondiscrimination in Health Coverage in the Group Market (CMS-2022-F)...............     0938-AM14
1156        Bona Fide Wellness Programs (CMS-2078-F)............................................     0938-AM15
1157        Time Limitation on Recalculations and Disputes Under the Drug Rebate Program (CMS-       0938-AM20
            2175-FC)............................................................................
1158        Medicaid Estate Recoveries (CMS-2083-P).............................................     0938-AM30
1159        Application of the Emergency Medical Treatment and Labor Act (EMTALA) (CMS-1063-F)..     0938-AM34
1160        Physician Ownership in Specialty Hospitals (CMS-1240-P).............................     0938-AM35
1161        Approval of the Joint Commission on Accreditation of Healthcare Organizations            0938-AM38
            (JCAHO) for Deeming Authority for Hospices (CMS-2177-FN)............................
1162        Hospital Cost-to-Charge Ratios Used To Calculate Cost Outlier Payments Under the         0938-AM41
            Medicare Short-Term Inpatient Prospective Payment System (CMS-1243-F)...............
1163        Ambulance Fee Schedule Condition Codes (CMS-1247-P).................................     0938-AM45
1164        Hospice Wage Index for FY 2004 (CMS-1233-N).........................................     0938-AM56
1165        Announcement of Applications From Hospitals Requesting Waivers for Organ Procurement     0938-AM59
            Service Areas in Calendar Year 2003 (CMS-1246-NC)...................................
1166        Centers for Medicare and Medicaid Services Action on Liability Insurance Regulations     0938-AM64
            (CMS-1475-FC).......................................................................
----------------------------------------------------------------------------------------------------------------


                          Administration for Children and Families--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
1167        Safeguarding Child Support and Expanded Federal Parent Locator Services (FPLS)           0970-AC01
            Information.........................................................................
1168        Developmental Disabilities and Bill of Rights Act...................................     0970-AC07
1169        Administrative Costs for Children in Title IV-E Foster Care.........................     0970-AC14
1170        Administrative Cost Sharing Under TANF..............................................     0970-AC15
----------------------------------------------------------------------------------------------------------------


                           Administration for Children and Families--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
1171        Child Support Enforcement for Indian Tribes.........................................     0970-AB73
1172        Child Support Enforcement Program; Federal Tax Refund Offset........................     0970-AC09
1173        Charitable Choice Provisions Applicable to the Temporary Assistance for Needy            0970-AC12
            Families Program....................................................................

[[Page 72870]]

 
1174        Community Services Block Grant Charitable Choice....................................     0970-AC13
----------------------------------------------------------------------------------------------------------------


                           Administration for Children and Families--Completed Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
1175        Construction and Major Renovation of Head Start and Early Head Start Facilities.....     0970-AB54
1176        Child Support Enforcement Program Omnibus Conforming Regulation.....................     0970-AB81
1177        Technical Revision of Head Start Regulations To Make Them Conform to Recent              0970-AC00
            Statutory Revisions.................................................................
1178        Child Support Enforcement Program; Expenditures for Caseworker Costs................     0970-AC11
----------------------------------------------------------------------------------------------------------------


                                  Administration on Aging--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
1179        Grants for State and Community Programs on Aging, Training, Research, and                0985-AA00
            Discretionary Programs; Vulnerable Elder Rights; Grants to Indians and Native
            Hawaiians...........................................................................
----------------------------------------------------------------------------------------------------------------

_______________________________________________________________________


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


Office of the Secretary (OS)



_______________________________________________________________________




961. 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                            04/00/04
NPRM Comment Period End         06/00/04

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

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

RIN: 0991-AB06
_______________________________________________________________________




962. CLAIMS COLLECTION

Priority: Substantive, Nonsignificant

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

CFR Citation: 45 CFR 30

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            02/00/04
NPRM Comment Period End         04/00/04
Final Rule                      06/00/04

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-AB18
_______________________________________________________________________




963. SALARY OFFSET

Priority: Substantive, Nonsignificant

Unfunded Mandates: Undetermined

Legal Authority: 5 USC 5514; 5 CFR 550

[[Page 72871]]

CFR Citation: 45 CFR 33

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            03/00/04
NPRM Comment Period End         05/00/04
Final Rule                      09/00/04

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
_______________________________________________________________________




964. [bull] HEALTH INSURANCE PORTABILITY AND ACCOUNTABILITY ACT--
ENFORCEMENT

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

RIN: 0991-AB29
_______________________________________________________________________


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


Office of the Secretary (OS)



_______________________________________________________________________




965. SHARED RISK EXCEPTION TO THE SAFE HARBOR PROVISIONS

Priority: Substantive, Nonsignificant

Legal Authority: 42 USC 1302; 42 USC 1320a900-7b; 42 USC 1395hh; PL 
104-191, sec 216(b)

CFR Citation: 42 CFR 1001

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

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                      04/00/04

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

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

RIN: 0991-AA91
_______________________________________________________________________




966. 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                      04/00/04

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
_______________________________________________________________________




967. TAX REFUND OFFSET

Priority: Other Significant

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. 1321-1358, as 
implemented by the Department of the Treasury at 31 CFR 285.2. The 
proposed rule revises the process by which the Department collects its 
debts. The

[[Page 72872]]

proposed rule is required in order to bring the Department's tax refund 
offset provisions in compliance with the Department of the Treasury 
regulations.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/04/02                    67 FR 72128
NPRM Comment Period End         02/03/03
Final Rule                      12/00/03

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 4760, HHS Cohen Building, 330 
Independence Avenue SW., Washington, DC 20201
Phone: 202 619-0150

RIN: 0991-AB17
_______________________________________________________________________




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

Priority: Other Significant

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                      01/00/04

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

RIN: 0991-AB22
_______________________________________________________________________




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

Priority: Substantive, Nonsignificant

Legal Authority: Sec 112B (6) (6)(A) of the Social Security Act

CFR Citation: 42 CFR 1001

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/15/03                    68 FR 53939
NPRM Comment Period End         11/14/03
Final Action                    05/00/04

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

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

RIN: 0991-AB23
_______________________________________________________________________


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


Office of the Secretary (OS)



_______________________________________________________________________




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

Priority: Substantive, Nonsignificant

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

CFR Citation: 42 CFR 1003

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                             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

[[Page 72873]]

_______________________________________________________________________




971. 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, 200 Independence Avenue SW., Washington, DC 20202
Phone: 202 619-0403

RIN: 0991-AB10
_______________________________________________________________________


Department of Health and Human Services (HHS)         Completed Actions


Office of the Secretary (OS)



_______________________________________________________________________




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

Priority: Substantive, Nonsignificant

CFR Citation: 45 CFR 76; 45 CFR 82

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    11/26/03                    68 FR 66533

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Diane Osterhus
Phone: 202 690-5729
Fax: 202 690-6901
Email: [email protected]

RIN: 0991-AB12
_______________________________________________________________________


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


Substance Abuse and Mental Health Services Administration (SAMHSA)



_______________________________________________________________________




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

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

RIN: 0930-AA10
_______________________________________________________________________




974. [bull] MANDATORY GUIDELINES FOR THE FEDERAL WORKPLACE DRUG TESTING 
PROGRAM

Priority: Other Significant

Legal Authority: PL 100-71; 5 USC 7301

CFR Citation: None

Legal Deadline: NPRM, Statutory, December 2003, NPRM.

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Notice                          12/00/03

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: Federal

Agency Contact: Joseph Denis Faha, Director, DLEA, SAMHSA, Department 
of Health and Human Services, Substance Abuse and Mental Health 
Services Administration, Room 12C-15, 5600 Fishers Lane, Rockville, MD 
20857
Phone: 301 443-7017
Fax: 301 443-1450
Email: [email protected]

RIN: 0930-AA12

[[Page 72874]]

_______________________________________________________________________


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


Substance Abuse and Mental Health Services Administration (SAMHSA)



_______________________________________________________________________




975. SUBSTANCE ABUSE AND MENTAL HEALTH SERVICES ADMINISTRATION (SAMHSA) 
CHARITABLE CHOICE

Priority: Other Significant

Legal Authority: Not Yet Determined

CFR Citation: 42 CFR 54, sec 54.1-13; 42 CFR 54a, sec 54a.1-14

Legal Deadline: None

Abstract: This proposed rule would implement the Charitable Choice 
statutory provisions of section 581-584 and section 1955 of the Public 
Health Service Act, applicable to the Substance Abuse Prevention and 
Treatment (SAPT) Block Grant Program, the Project for Assistance in 
Transition from Homelessness (PATH) formula grant program, insofar as 
recipients provide substance abuse services, and to SAMHSA 
discretionary grants for substance abuse treatment or prevention 
services, which are all administered by SAMSHA of the U.S. Department 
of Health and Human Services.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/17/02                    67 FR 77350
Final Rule                      02/00/04

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: Federal

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

Agency Contact: Winnie Mitchell, Public Health Analyst, Department of 
Health and Human Services, Substance Abuse and Mental Health Services 
Administration, 12C-05, 5600 Fishers Lane, Rockville, MD 20857
Phone: 301 443-2324
Fax: 301 443-0247

RIN: 0930-AA11
_______________________________________________________________________


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


Centers for Disease Control and Prevention (CDC)



_______________________________________________________________________




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

Priority: Other Significant

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

CFR Citation: 42 CFR 84

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/00/03

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)



_______________________________________________________________________




977. 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 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                      12/00/03

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

[[Page 72875]]

_______________________________________________________________________


Department of Health and Human Services (HHS)             Prerule Stage


Food and Drug Administration (FDA)



_______________________________________________________________________




978. 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 201; 21 CFR 310; 21 CFR 330 to 350

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:
________________________________________________________________________

Anorectal Products (0910-AC65)  Final Action (Amendment) 08/26/03 (68 
FR 51167)

Antidiarrheal Products (0910-AC82)  NPRM (Amendment) (Trav. Diar) 04/
17/03 (68 FR 18915)  Final Action (Amendment) (Trav. Diar) 04/00/04

Antiemetic Products (0910-AC71)  Final Action (Amendment) (Warning) 12/
06/02 (67 FR 72555)

Antiperspirant Products (0910-AC89)  Final Action 06/09/03 (68 FR 
34273)

Cough/Cold (Antihistamine) Products (0910-AD31)  Final Action 
(Amendment)(Common Cold) 04/00/04

Cough/Cold (Antitussive) Products (0910-AD24)  Final Action 
(Amendment)(Warning) 12/06/02 (67 FR 72555)

Cough/Cold (Bronchodilator) Products (0910-AD33)  NPRM (Amendment) 06/
00/04

Cough/Cold (Combination) Products (0910-AD25)  Final Action 12/23/02 
(67 FR 78158)  NPRM (Amendment) 06/00/04

Cough/Cold (Nasal Decongestant) Products (0910-AD43)  NPRM 
(Phenylephrine Bitartrate) 04/00/04  NPRM (Phenylpropanolamine) 04/00/
04  NPRM (Amendment) (Sinusitis Claim) 06/00/04

External Analgesic Products (0910-AD06)  Final Action 
(Amendment)(Warning) 12/06/02 (67 FR 72555)  NPRM (Amendment) (Patches) 
07/17/03 (68 FR 42324)

Ingrown Toenail Relief Products (0910-AD21)  NPRM 10/04/02 (67 FR 
62218)  Final Action 05/07/03 (68 FR 24347)

Internal Analgesic Products (0910-AD07)  NPRM (Amendment)(Ibuprofen) 
08/21/02 (67 FR 54139)  NPRM (Amendment) (Labeling) 04/00/04  NPRM 
(Amendment) (Pediatric) 04/00/04

Labeling of Drug Products for OTC Human Use (0910-AD47)  NPRM 
(Convenience Sizes) 02/00/04  NPRM (Sodium Labeling) 02/00/04  Final 
Action (Sodium Labeling) 02/00/04  Final Action (Ca/Mg/K/Na) 02/00/04

Laxative Drug Products (0910-AC85)  NPRM (Amendment) (Psyllium Granular 
Dosage Form) 08/05/03 (68 FR 46133)

Nighttime Sleep Aid Products (0910-AD11)  Final Action 
(Amendment)(Warning) 12/06/02 (67 FR 72555)

Ophthalmic Products (0910-AC72)  NPRM (Emergency First Aid Eyewashes) 
02/19/03 (68 FR 7951)  Final Action (Technical Amendment) 02/19/03 (68 
FR 7919)  Final Action (Name Change) 06/03/03 (68 FR 32981)

Oral Health Care Products (0910-AC98)  ANPRM (Plaque/Gingivitis) 05/29/
03 (68 FR 32232)

Pediculicide Products (0910-AC79)  NPRM (Labeling Amendment) 05/10/02 
(67 FR 31739)  Final Action (Labeling Amendment) 02/00/04

Salicylate (Reye's Syndrome) (0910-AD13)  Final Action (Warning) 04/17/
03 (68 FR 18861)

Skin Protectant Products (0910-AC96)  Final Action 06/04/03 (68 FR 
33362)  NPRM (Astringent) 06/13/03 (68 FR 35346)  Final Action 
(Astringent) 06/13/03 (68 FR 35290)  Final Action (Astringent) (Confirm 
Effective Date) 10/09/03 (68 FR 58273)  Final Action (Technical 
Amendment) 12/00/03

Sunscreen Products (0910-AC68)  Final Action (Names) 06/20/02 (67 FR 
41821)  ANPRM (and Insect Repellent) 04/00/04  NPRM (UVA/UVB) 04/00/04

Vaginal Contraceptive Products (0910-AD19)  NPRM (Amendment) 01/16/03 
(68 FR 2254)  Final Action (Warnings) 06/00/04

Weight Control Products (0910-AC93)  NPRM (Phenylpropanolamine) 04/00/
04

Regulatory Flexibility Analysis Required: Yes

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
_______________________________________________________________________




979. CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKING, OR 
HOLDING HUMAN FOOD (PART 110)

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

Unfunded Mandates: Undetermined

Legal Authority: 21 USC 342; 21 USC 371; 21 USC 374; 42 USC 264

CFR Citation: 21 CFR 110

Legal Deadline: None

Abstract: Part 110 (21 CFR part 110) describes regulations for current 
good manufacturing practice in manufacturing, packing, and holding 
human food. Part 110 contains regulations describing sanitary practices 
for personnel, buildings and facilities, and equipment. It also 
includes regulations on production and process controls for 
manufacturing practices and on defect action levels for natural or 
unavoidable defects in food for human use that present no health 
hazard. FDA is undertaking a review of part 110 under section 610 of 
the Regulatory Flexibility Act. The purpose of this review is to 
determine whether the regulations in part 110 should be continued 
without change, or whether they should be amended or rescinded, 
consistent with the stated objectives of applicable statutes, to 
minimize adverse impacts on a substantial number of small entities. FDA 
will consider, and is soliciting comments on, the following: (1) the 
continued need for the regulations in part 110; (2) the nature of 
complaints or comments received concerning the regulations in part 110; 
(3) the complexity of the regulations in part 110; (4) the extent to 
which the regulations in part 110 overlap, duplicate, or conflict with 
other Federal, State, or governmental rules; and (5) the degree to 
which technology, economic conditions, or other factors have changed in 
the area affected by the regulations in part 110.

[[Page 72876]]

The section 610 review will be carried out along with a regulatory 
review under section 5 of Executive Order 12866, which calls for 
agencies to periodically review existing regulations to determine 
whether any should be modified or eliminated so as to make the agency's 
regulatory program more effective in achieving its goals, less 
burdensome, or in greater alignment with the President's priorities and 
the princples set forth in the Executive order. The combined effect of 
the two reviews will be to determine if it is possible to redesign 
current good manufacturing practices in ways that will maintain or 
increase the effectiveness of preventive and sanitary controls, and, at 
the same time, reduce compliance and other costs associated with the 
regulations.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Begin Review                    05/01/03
End Review                      12/00/03

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Federalism:  Undetermined

Agency Contact: Richard A. Williams, Director, Division of Market 
Studies, OSAS, CFSAN, FDA, HHS, Department of Health and Human 
Services, Food and Drug Administration, HFS-725, 5100 Paint Branch 
Parkway, College Park, MD 20740
Phone: 301 436-1989
Fax: 301 436-2626
Email: [email protected]

RIN: 0910-AC58
_______________________________________________________________________




980. [bull] HEALTH CLAIMS

Priority: Other Significant

Unfunded Mandates: Undetermined

Legal Authority: 21 USC 343; 21 USC 371

CFR Citation: Not Yet Determined

Legal Deadline: None

Abstract: This advance notice of proposed rulemaking (ANPRM) was 
signaled in the July 11, 2003 (68 FR 41387) notice that announced the 
availability of the Report of Task Force on Consumer Health Information 
for Better Nutrition (the Task Force) and two guidance documents. The 
July 11, 2003, notice states that in the near future, the agency 
intends to publish an ANPRM consistent with the recommendations of the 
Task Force.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

ANPRM                           11/25/03                    68 FR 66040
Next Action Undetermined

Regulatory Flexibility Analysis Required: Yes

Government Levels Affected: None

Federalism:  Undetermined

Agency Contact: Paulette Gaynor, Consumer Safety Officer, Department of 
Health and Human Services, Food and Drug Administration, HFS-800, 5100 
Paint Branch Parkway, College Park, MD 20740
Phone: 301 436-1450
Fax: 301 436-2636
Email: [email protected]

RIN: 0910-AF09
_______________________________________________________________________




981. [bull] PRESCRIPTION DRUG MARKETING ACT OF 1987; PRESCRIPTION DRUG 
AMENDMENTS OF 1992; POLICIES, REQUIREMENTS, AND ADMINISTRATIVE 
PROCEDURES; DERIVATIVES OF BLOOD

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

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

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

Legal Deadline: Other, Statutory, April 1, 2004, Other.
Date final rule takes effect: ?Prescription Drug Marketing Act of 1987; 
Prescription Drug Amendments of 1992; Policies, Requirements, and 
Administrative Procedures.``.

Abstract: FDA is proposing to amend the implementing regulation of the 
Prescription Drug Marketing Act of 1987, as modified by the 
Prescription Drug Amendments of 1992 and the FDA Modernization Act of 
1997. The final rule (12/3/99; 64 FR 67720), does not allow a 
registered blood establishment that provides health care services 
related to its activities as a blood establishment to concurrently 
distribute derivatives of blood. The effective date of that rule is 
April 1, 2004. FDA is amending the final rule to allow a registered 
blood establishment that concurrently provides health care services to 
also distribute derivatives of blood.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

ANPRM                           07/00/04

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: None

Agency Contact: Kathleen E. Swisher, Regulatory Counsel, Department of 
Health and Human Services, Food and Drug Administration, Center for 
Biologics Evaluation and Research, 1401 Rockville Pike Suite 200N, 
Rockville, MD 20852
Phone: 301 827-6210
Fax: 301 827-9434

RIN: 0910-AF16
_______________________________________________________________________


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


Food and Drug Administration (FDA)



_______________________________________________________________________




982. FOREIGN AND DOMESTIC ESTABLISHMENT REGISTRATION AND LISTING 
REQUIREMENTS 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; 42 
USC 264; 42 USC 271

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

Legal Deadline: None

Abstract: The 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,

[[Page 72877]]

and modify current regulations concerning who must register 
establishments and list drug or biologics regulated as drugs. 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 revise the requirements for the 
National Drug Code number and would require the electronic submission 
of most registration and listing information.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            03/00/04

Regulatory Flexibility Analysis Required: Yes

Government Levels Affected: None

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

RIN: 0910-AA49
_______________________________________________________________________




983. 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 
(FDA) 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 FDA's comprehensive review of the biologics 
regulations. It is also based on reports by the U.S. House of 
Representatives Committee on Government Reform and Oversight's, 
Subcommittee on House Resources and Intergovernmental Relations, the 
General Accounting Office, and the Institute of Medicine, as well as on 
public comments. The remaining subjects intended to be addressed in the 
rulemakings include: labeling of blood and blood components and donor 
eligibility requirements. 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 (0910-AE95)  NPRM 05/14/99 (64 FR 
26344)  Direct Final Rule 05/14/99 (64 FR 26282)  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 (0910-AE99)  NPRM 08/19/99 
(64 FR 45355)  Final Action 06/11/01 (66 FR 31165)

Plasma Derivatives and Similar Recombinant-Based Products; Requirements 
for Notification of Recalls and Withdrawals (0910-AF02)  ANPRM 08/19/99 
(64 FR 45383)

Regulations for Human Blood and Blood Components Intended for 
Transfusion or for Further Manufacturing Use (0910-AF00)  NPRM 11/00/04

Requirements for Testing Human Blood Donors for Evidence of Infection 
Due to Communicable Disease Agents (0910-AE98)  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 (0910-AE96)  NPRM 07/30/03 (68 FR 
44678)  Correction Notice 10/27/03 (68 FR 61172)  NPRM Comment Period 
End 10/30/03  Final Action 10/00/04

Revisions to the Requirements Applicable to Blood, Blood Components, 
and Source Plasma (0910-AE89)  NPRM 08/19/99 (64 FR 45375)  Direct 
Final Rule 08/19/99 (64 FR 45366)  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: 301 827-9434

RIN: 0910-AB26
_______________________________________________________________________




984. 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                            05/00/04

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Federalism:  Undetermined

Agency Contact: Brian L. Pendleton, Regulatory Counsel, Department of 
Health and Human Services, Food and Drug Administration, Suite 3037 
(HFD-7), Center for Drug Evaluation and Research, 1451 Rockville Pike, 
Rockville, MD 20852
Phone: 301 594-5649
Fax: 301 827-5562
Email: [email protected]

RIN: 0910-AB34

[[Page 72878]]

_______________________________________________________________________




985. CURRENT GOOD MANUFACTURING PRACTICE FOR MEDICATED FEEDS

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

Unfunded Mandates: Undetermined

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

CFR Citation: 21 CFR 225

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/00/04

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
_______________________________________________________________________




986. 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 to 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.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/00/03

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

RIN: 0910-AB96
_______________________________________________________________________




987. PREVENTION OF SALMONELLA ENTERITIDIS IN SHELL EGGS

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

RIN: 0910-AC14
_______________________________________________________________________




988. 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                            03/00/04

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

RIN: 0910-AC17
_______________________________________________________________________




989. 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

[[Page 72879]]

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                            03/00/04

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
_______________________________________________________________________




990. 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.
In addition to this proposed rule, FDA intends to issue guidance within 
the next few months on the use in animal feed or material from deer and 
elk that are positive for CWD or are at high risk of CWD.
CWD is a type of transmissible spongiform encephalopathy (TSE), a group 
of fatal, neurodegenerative diseases that include bovine spongiform 
encephalopathy (BSE) in cattle, scrapie in sheep and goats, and 
Creutzfeldt-Jakob disease (CJD) in humans. The disease has been 
identified in wild and farmed elk and wild deer populations.
CWD has been found in cervid populations in certain areas of Wisconsin, 
Colorado, Nebraska, Wyoming, Kansas, Montana, Oklahoma, South Dakota, 
New Mexico, Minnesota, and Canada. In 1999, the World Health 
Organization said there is no evidence that CWD transmits to humans. 
However, it also suggested any part of a deer or elk believed to be 
diseased should not be eaten. Results of some studies using in vitro 
techniques have suggested that transmission to humans could possibly 
occur. However, if it does occur, it is likely to be through a very 
inefficient process.
Currently, there are no validated analytical tests to identify animals 
in the preclinical phase of CWD, or any other TSE. In addition, no test 
exists to ensure food safety. CWD typically exhibits a long incubation 
period, during which time animals appear normal but are potentially 
infectious. Therefore, FDA is proposing to require that food or 
cosmetic products derived from animals exposed to CWD not enter into 
commerce.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/00/04

Regulatory Flexibility Analysis Required: Yes

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
_______________________________________________________________________




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

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

RIN: 0910-AC25
_______________________________________________________________________




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

Priority: Substantive, Nonsignificant

Legal Authority: 21 USC 351; 21 USC 352; 21 USC 360c(e)(1); 21 USC 371

CFR Citation: 21 CFR 868.2700; 21 CFR 868.5905

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/00/03

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

[[Page 72880]]

Phone: 301 827-2974
Fax: 301 594-4795
Email: [email protected]

RIN: 0910-AC30
_______________________________________________________________________




993. 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
_______________________________________________________________________




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

Priority: Other Significant

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

CFR Citation: 21 CFR 101

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

ANPRM                           07/11/03                    68 FR 41507
ANPRM Comment Period End        10/09/03
NPRM                             To Be                       Determined

Regulatory Flexibility Analysis Required: No

Government Levels Affected: Federal

Agency Contact: Julie Schrimpf, Department of Health and Human 
Services, Food and Drug Administration, (HFS-832), HFS-800, Center for 
Food Safety and Applied Nutrition, 5100 Paint Branch Parkway, College 
Park, MD 20740
Phone: 301 436-2373
Fax: 301 436-2639
Email: [email protected]

RIN: 0910-AC50
_______________________________________________________________________




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

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

Legal Authority: 21 USC 355; 21 USC 371; 42 USC 262

CFR Citation: 21 CFR 314.50; 21 CFR 601.12; 21 CFR 314.94

Legal Deadline: None

Abstract: The Food and Drug Administration (FDA) is proposing to amend 
the regulations governing the format in which clinical study data (CSD) 
are required to be submitted for new drug applications (NDAs), 
biological license applications (BLAs), and abbreviated new drug 
applications (ANDAs). The proposal would revise our regulations to 
require CSD submitted for NDAs, ANDAs, BLAs, and their supplements and 
amendments be provided in electronic format and require the use of 
standard data structure, terminology, and code sets. The proposal would 
improve the efficiency of the exchange of information from clinical 
studies through the adoption of standards for study data submitted in 
an electronic form that FDA can process, review, and archive.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            07/00/04

Regulatory Flexibility Analysis Required: Yes

Government Levels Affected: Undetermined

Agency Contact: Nicole K. Mueller, Regulatory Counsel, Department of 
Health and Human Services, Food and Drug Administration, Room 3037, 
(HFD-7), 1451 Rockville Pike, Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 594-6197
Email: [email protected]

RIN: 0910-AC52
_______________________________________________________________________




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

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

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

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

Legal Deadline: None

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

[[Page 72881]]

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            07/00/04

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: None

Agency Contact: Elaine H. Tseng, Office of Regulatory Policy, 
Department of Health and Human Services, Food and Drug Administration, 
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-AC53
_______________________________________________________________________




997. FOOD STANDARDS: GENERAL PRINCIPLES AND FOOD STANDARDS MODERNIZATION

Priority: Other Significant

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

CFR Citation: 21 CFR 130.5

Legal Deadline: None

Abstract: In 1995, the FDA and FSIS reviewed their regulatory 
procedures and requirements for food standards to determine whether any 
were still needed, and if so, whether any should be modified or 
streamlined. To request public comment to assist them in their review 
of the need for food standards, both agencies published advance notices 
of proposed rulemaking (ANPRMs) on food standards in December 1995 (61 
FR 47453 and 61 FR 67492). These ANPRMs discussed the agencies' 
regulations and policy governing food standards, the history of food 
standards, and the possible need to revise the food standards. Several 
comments in response to the ANPRMs recommended that the agencies 
establish general principles or a fundamental philosophy for reviewing 
food standards and revising them. The agencies agreed with these 
comments and determined that it would be appropriate to develop general 
principles for reviewing and revising food standards regulations. The 
agencies also agreed with the comments that stated that the agencies 
should work in concert to develop consistent food standards 
regulations. FDA and FSIS are now proposing a set of general principles 
that define how modern food standards should be structured. If this 
proposed rule is adopted, FDA and FSIS will require that a citizen 
petition for establishing, revising, or eliminating a food standard in 
21 CFR parts 130 to 169 and 7 CFR part 410 be submitted in accordance 
with the general principles. Conversely, the agencies may find 
deficient a petition to establish, revise, or eliminate a food standard 
that does not follow these general principles.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

ANPRM                           12/29/95                    60 FR 67492
ANPRM Comment Period End        04/29/96
NPRM                            05/00/04

Regulatory Flexibility Analysis Required: Yes

Government Levels Affected: Undetermined

Federalism:  Undetermined

Agency Contact: Ritu Nalubola, Staff Fellow, Department of Health and 
Human Services, Food and Drug Administration, HFS-820, Center for Food 
Safety and Applied Nutrition, Harvey Wiley Building, 5100 Paint Branch 
Parkway, College Park, MD 20740
Phone: 301 436-2371
Fax: 301 436-2636
Email: [email protected]

RIN: 0910-AC54
_______________________________________________________________________




998. POSITRON EMISSION TOMOGRAPHY DRUGS; CURRENT GOOD MANUFACTURING 
PRACTICES

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

Unfunded Mandates: Undetermined

Legal Authority: PL 105-115, sec 121

CFR Citation: 21 CFR 220

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

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            03/00/04

Regulatory Flexibility Analysis Required: Yes

Government Levels Affected: Federal, State

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

Agency Contact: Wayne H. Mitchell, Regulatory Counsel, Office of 
Regulatory Policy, Department of Health and Human Services, Food and 
Drug Administration, Suite 3037 (HFD-7), 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-AC55
_______________________________________________________________________




999. REVISION OF THE REQUIREMENTS FOR SPORE-FORMING MICROORGANISMS

Priority: Other Significant

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

CFR Citation: 21 CFR 600.10(c); 21 CFR 600.11(e)

Legal Deadline: None

Abstract: The Food and Drug Administration (FDA) is issuing a direct 
final rule and a companion proposed rule to amend the biologics 
regulations by providing options to the existing requirement for 
separate, dedicated facilities and equipment for work with spore-
forming microorganisms. FDA is taking this action due to advances in 
facility, system and equipment design, and sterilization technologies, 
that would allow work with spore-forming microorganisms to be performed 
in multi-product manufacturing areas.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM--Companion to Direct Final 
Rule                            04/00/04
Direct Final Rule               04/00/04

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Valerie Butler, Consumer Safety Officer, Department of 
Health and Human Services, Food and

[[Page 72882]]

Drug Administration, Suite 200N (HFM-17), 1401 Rockville Pike, 
Rockville, MD 20852
Phone: 301 827-6210
Fax: 301 827-9434

RIN: 0910-AC57
_______________________________________________________________________




1000. REPORTING INFORMATION REGARDING FALSIFICATION OF DATA

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

Unfunded Mandates: Undetermined

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

CFR Citation: 21 CFR 70.3; 21 CFR 71.1; 21 CFR 170.3; 21 CFR 171.1; 21 
CFR 312.3; 21 CFR 312.56; 21 CFR 510.3; 21 CFR 511.1; 21 CFR 812.46

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/00/03

Regulatory Flexibility Analysis Required: Undetermined

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), Suite 3059 (HFD-7), Center for Drug Evaulation and Research, 
1451 Rockville Pike, Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562

RIN: 0910-AC59
_______________________________________________________________________




1001. [bull] DEFINITION OF ``SERIOUS ADVERSE HEALTH CONSEQUENCES'' UNDER 
THE PUBLIC HEALTH SECURITY AND BIOTERRORISM PREPAREDNESS AND RESPONSE 
ACT OF 2002

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

RIN: 0910-AF06
_______________________________________________________________________




1002. [bull] QUALITY STANDARD REGULATION ESTABLISHING ALLOWABLE LEVEL 
FOR ARSENIC IN BOTTLED WATER

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

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

CFR Citation: 21 CFR 165.110(b)

Legal Deadline: Final, Statutory, July 27, 2005, Final.

Abstract: Under section 410 of the Federal Food, Drug, and Cosmetic Act 
(the Act), not later than 180 days before the effective date of a 
National Primary Drinking Water Regulation (NPDWR) issued by the 
Environmental Protection Agency (EPA) for a contaminant under section 
1412 of the Safe Drinking Water Act, the Food and Drug Administration 
(FDA) is required to issue a standard of quality regulation for that 
contaminant in bottled water or make a finding that such a regulation 
is not necessary to protect the public health because the contaminant 
is contained in water in public water systems but not in water used for 
bottled water. The effective date for any such standard of quality 
regulation is to be the same as the effective date of the NPDWR. On 
January 22, 2001, EPA published a final rule revising the existing 0.05 
mg/L maximum contaminant level (MCL) for arsenic in public drinking 
water to 0.01 mg/L (10 ppb). The effective date for this rule was 
temporarily delayed for 60 days from March 23, 2001, to a new effective 
date of May 22, 2001, in accordance with the memorandum of January 20, 
2001, from the Assistant to the President and Chief of Staff, entitled 
``Regulatory Review Plan'' (66 FR 7701; January 24, 2001). On May 22, 
2001, EPA announced that it would further delay the effective date for 
the rule until February 22, 2002, to allow time to complete a 
reassessment of the information on which the revised arsenic standard 
is based. On February 22, 2002, the arsenic MCL of 0.01 mg/L in public 
drinking water rule became effective and water systems must comply with 
the new standard for arsenic in public drinking water by January 23, 
2006. In accordance with section 410 of the Act, FDA is required to 
issue a standard of quality regulation for arsenic in bottled drinking 
water by July 27, 2005, with an effective date of January 23, 2006, or 
make a finding that such a regulation is not necessary to protect the 
public health.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/00/04
NPRM Comment Period End         11/00/04

Regulatory Flexibility Analysis Required: Yes

Government Levels Affected: Undetermined

Federalism:  Undetermined

Agency Contact: Dr. Henry Kim, Supervisory Interdisciplinary Scientist, 
Department of Health and Human Services, Food and Drug Administration, 
HFS-306, 5100 Paint Branch Parkway, College Park, MD 20740
Phone: 301 436-2023
Fax: 301-436-2651
Email: [email protected]

RIN: 0910-AF10
_______________________________________________________________________




1003. [bull] CONTENT AND FORMAT OF LABELING FOR HUMAN PRESCRIPTION DRUGS 
AND BIOLOGICS; REQUIREMENTS FOR PREGNANCY AND LACTATION

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 358; 21 USC 360; 21 USC 360(b); 21 USC 360gg to 360ss; 21 USC 
371; 21 USC 374; 21 USC 379e; 42 USC 216; 42 USC 241; 42 USC 262; 42 
USC 264

CFR Citation: 21 CFR 201.57

Legal Deadline: None

Abstract: The proposed rule would amend FDA regulations concerning the 
format and content of the ``Pregnancy,'' ``Labor and Delivery,'' and 
``Nursing

[[Page 72883]]

Mothers'' subsections of the ``Use in Specific Populations'' section of 
the labeling for human prescription drugs. The proposal would require 
that labeling include a summary of the risks of using a drug during 
pregnancy and lactation and a discussion of the data supporting that 
summary.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            07/00/04

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected: Businesses

Government Levels Affected: Undetermined

Federalism:  Undetermined

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

RIN: 0910-AF11
_______________________________________________________________________




1004. [bull] COCHINEAL EXTRACT AND CARMINE LABEL DECLARATION

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

Legal Authority: 21 USC 379e(b)

CFR Citation: 21 CFR 73.100 (d); 21 CFR 73.1100 (c); 21 CFR 73.2087 
(c); 21 CFR 101.22 (k); 21 CFR 701.3; 21 CFR 740.20

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/00/04

Regulatory Flexibility Analysis Required: Yes

Government Levels Affected: None

Agency Contact: Mical E Honigfort, Consumer Safety Officer, Department 
of Health and Human Services, Food and Drug Administration, HFS-265, 
5100 Paint Branch Parkway, College Park, MD 20740
Phone: 202 418-0714
Fax: 202-418-3126
Email: [email protected]

RIN: 0910-AF12
_______________________________________________________________________




1005. [bull] CHARGING FOR INVESTIGATIONAL DRUGS

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; 42 USC 262

CFR Citation: 21 CFR 312.7; 21 CFR 312.8

Legal Deadline: None

Abstract: The proposed rule would amend FDA's investigational new drug 
application regulations concerning charging for investigational drugs. 
The proposed rule describes the types of investigational uses for which 
a sponsor may be able to charge, including uses for which charging was 
not previously expressly permitted, and the criteria for allowing 
charging for the identified investigational uses. The proposed rule 
would also describe the types of costs that can be recovered when 
charging for an investigational drug.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            07/00/04

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected: Businesses

Government Levels Affected: Undetermined

Federalism:  Undetermined

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

RIN: 0910-AF13
_______________________________________________________________________




1006. [bull] TREATMENT USE OF INVESTIGATIONAL DRUGS

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 353; 
21 USC 355; 21 USC 371; 42 USC 262

CFR Citation: 21 CFR 312.42; 21 CFR 312.400; 21 CFR 312.405; 21 CFR 
312.410; 21 CFR 312.415; 21 CFR 312.420; 21 CFR 312.425; 21 CFR 
312.430; 21 CFR 312.435

Legal Deadline: None

Abstract: The proposed rule would amend FDA regulations governing 
investigational new drug applications (INDs) to describe the way 
patients may obtain investigational drugs for treatment use. Treatment 
use of investigational drugs would be available to: (1) individual 
patients, including in emergencies; (2) intermediate size patient; and 
(3) larger populations under a treatment protocol or IND.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            07/00/04

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected: Businesses

Government Levels Affected: Undetermined

Federalism:  Undetermined

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

RIN: 0910-AF14
_______________________________________________________________________




1007. [bull] HUMAN SUBJECT PROTECTION; FOREIGN CLINICAL STUDIES NOT 
CONDUCTED UNDER AN INVESTIGATIONAL NEW DRUG APPLICATION

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

Unfunded Mandates: Undetermined

[[Page 72884]]

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

CFR Citation: 21 CFR 312.120

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            05/00/04

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Brian L. Pendleton, Regulatory Counsel, Department of 
Health and Human Services, Food and Drug Administration, Suite 3037 
(HFD-7), Center for Drug Evaluation and Research, 1451 Rockville Pike, 
Rockville, MD 20852
Phone: 301 594-5649
Fax: 301 827-5562
Email: [email protected]

RIN: 0910-AF15
_______________________________________________________________________




1008. [bull] USE OF OZONE-DEPLETING SUBSTANCES: REMOVAL OF ESSENTIAL USE 
DESIGNATION; ALBUTEROL

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

RIN: 0910-AF18
_______________________________________________________________________


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


Food and Drug Administration (FDA)



_______________________________________________________________________




1009. 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. On April 28, 2003, FDA reopened the comment period 
to update comments on the proposal. The comment period was extended on 
June 27, 2003, to end on August 26, 2003.

Timetable:
________________________________________________________________________

Current Good Mfg. Practices; Qual. Control Proc.; Quality Factors 
(0910-AD81)  NPRM 07/09/96 (61 FR 36154)  NPRM Comment Period End 12/
06/96  NPRM Comment Period Reopened 04/28/03 (68 FR 22341)  NPRM 
Comment Period Extended 06/27/03 (68 FR 38247)  NPRM Comment Period End 
08/26/03  Final Action 09/00/04

Infant Form Cons Comp, Micro Test & Recd Retention Req (0910-
AD80)  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 (0910-AD77)  NPRM Comment Period End 12/
06/96  NPRM Comment Period Reopened 04/28/03 (68 FR 22341)  NPRM 
Comment Period Extended 06/27/03 (68 FR 38247)  NPRM Comment Period End 
08/26/03  Final Action 09/00/04

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Charlotte Christin, Regulatory Counsel, Department of 
Health and Human Services, Food and Drug Administration, HFS-800, HFS-
024, Center for Food Safety and Applied Nutrition, 5100 Paint Branch 
Parkway, College Park, MD 20740
Phone: 301 436-1589
Email: [email protected]

RIN: 0910-AA04
_______________________________________________________________________




1010. INVESTIGATIONAL NEW DRUGS: EXPORT REQUIREMENTS FOR UNAPPROVED NEW 
DRUG PRODUCTS

Priority: Routine and Frequent

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

CFR Citation: 21 CFR 312.110

Legal Deadline: None

Abstract: The final rule would amend the regulations on the exportation 
of unapproved new drug products, including biological products, for 
investigational use. In general, the rule would provide four different 
routes for exporting an unapproved new drug product for investigational 
use. One route would permit exportation, if the drug is the subject of 
an investigational new drug application (IND) and is being exported for 
use in the investigation. A second route would permit exportation, 
without prior Food and Drug Administration (FDA) approval and without 
an IND, if the product is to be exported for use in a clinical 
investigation and has received marketing authorization in

[[Page 72885]]

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                    12/00/03

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

RIN: 0910-AA61
_______________________________________________________________________




1011. 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                    01/00/04

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

RIN: 0910-AA89
_______________________________________________________________________




1012. LABELING FOR HUMAN PRESCRIPTION DRUGS; REVISED FORMAT

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

RIN: 0910-AA94
_______________________________________________________________________




1013. SAFETY REPORTING REQUIREMENTS FOR HUMAN DRUG AND BIOLOGICAL 
PRODUCTS

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

RIN: 0910-AA97
_______________________________________________________________________




1014. 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                    01/00/04

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: 301 594-5601
Fax: 301 827-5562
Email: [email protected]

RIN: 0910-AB61
_______________________________________________________________________




1015. CGMP FOR BLOOD AND BLOOD COMPONENTS: NOTIFICATION OF CONSIGNEES 
AND TRANSFUSION RECIPIENTS RECEIVING BLOOD AND BLOOD COMPONENTS AT 
INCREASED RISK OF TRANSMITTING HCV INFECTION (LOOKBACK)

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

RIN: 0910-AB76

[[Page 72886]]

_______________________________________________________________________




1016. CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKING, OR 
HOLDING DIETARY INGREDIENTS AND DIETARY SUPPLEMENTS

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

RIN: 0910-AB88
_______________________________________________________________________




1017. REQUIREMENTS FOR SUBMISSION OF LABELING FOR HUMAN PRESCRIPTION 
DRUGS AND BIOLOGICS IN ELECTRONIC FORMAT

Priority: Other Significant

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

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; 42 USC 262; . . .

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 are 
required to be submitted. The rule would require that certain labeling 
content described under section 201.100(d)(3) be submitted to FDA in 
electronic format.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            05/03/02                    67 FR 22367
Final Action                    12/00/03

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: Federal

Agency Contact: Nicole K. Mueller, Regulatory Counsel, Department of 
Health and Human Services, Food and Drug Administration, Room 3037, 
(HFD-7), 1451 Rockville Pike, Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 594-6197
Email: [email protected]

RIN: 0910-AB91
_______________________________________________________________________




1018. 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, Other.

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Rule                    04/24/01                    66 FR 20589
Final Rule                      03/00/04

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
_______________________________________________________________________




1019. BAR CODE LABEL REQUIREMENTS FOR HUMAN DRUG PRODUCTS AND BLOOD

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

RIN: 0910-AC26
_______________________________________________________________________




1020. 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                            03/31/03                    68 FR 15404
NPRM Comment Period End         06/30/03
Final Rule                      09/00/04

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
_______________________________________________________________________




1021. AMENDMENTS TO THE PERFORMANCE STANDARD FOR DIAGNOSTIC X-RAY 
SYSTEMS AND THEIR MAJOR COMPONENTS

Priority: Substantive, Nonsignificant

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

[[Page 72887]]

360hh to 360ss; 21 USC 371; 21 USC 381

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                            12/10/02                    67 FR 76056
Final Action                    03/00/04

Regulatory Flexibility Analysis Required: Yes

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
_______________________________________________________________________




1022. ADMINISTRATIVE DETENTION OF FOOD FOR HUMAN OR ANIMAL CONSUMPTION 
UNDER THE PUBLIC HEALTH SECURITY AND BIOTERRORISM PREPAREDNESS AND 
RESPONSE ACT OF 2002

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

RIN: 0910-AC38
_______________________________________________________________________




1023. ESTABLISHMENT AND MAINTENANCE OF RECORDS PURSUANT TO THE PUBLIC 
HEALTH SECURITY AND BIOTERRORISM PREPAREDNESS AND RESPONSE ACT OF 2002

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

RIN: 0910-AC39
_______________________________________________________________________




1024. REGISTRATION OF FOOD AND ANIMAL FEED FACILITIES

Priority: Economically Significant. Major under 5 USC 801.

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

Legal Authority: PL 107-188, sec 305

CFR Citation: 21 CFR 1

Legal Deadline: Final, Statutory, December 12, 2003, Final.
The Public Health Security and Bioterrorism Preparedness and Response 
Act of 2002, section 305, directs the Secretary, through FDA, to issue 
a final regulation establishing registration requirements by December 
12, 2003. The statute is self-implementing on this date if FDA does not 
issue a final regulation that is effective by December 12, 2003.

Abstract: This rulemaking is one of a number of actions being taken to 
improve FDA's ability to respond to threats of bioterrorism and other 
foodborne illness emergencies. Section 415 of the Federal Food, Drug, 
and Cosmetic Act (FFDCA), which was added by section 305 of the Public 
Health Security and Bioterrorism Preparedness and Response Act of 2002 
(the Bioterrorism Act), directs the Secretary to require any facility 
engaged in manufacturing, processing, packing, or holding of food for 
consumption by humans or animals in the United States to be registered 
with the Secretary through FDA. Section 415 directs the Secretary, 
through FDA, to promulgate final regulations implementing the 
requirements by December 12, 2003. The owner, operator, or agent in 
charge of the facility must submit the registration. Foreign facilities 
must include the name of the United States agent for the facility. The 
registration must include the name and address of each facility at 
which, and all trade names under which, the registrant conducts 
business. If FDA determines it is necessary through guidance, the 
registration must include the general food category (as identified 
under 21 CFR 170.3) of foods manufactured, processed, packed, or held 
at the facility. The registrant is required to notify the Secretary of 
changes to the registration in a timely manner. Under the proposed 
rule, upon receipt of the completed registration form, FDA would notify 
the registrant of receipt of the registration and assign a unique 
registration number to the facility. The Bioterrorism Act requires the 
Secretary to compile and maintain an up-to-date list of registered 
facilities. This list and any registration documents submitted to the 
Secretary are not subject to disclosure under the Freedom of 
Information Act. For purposes of section 415, ``facility'' includes any 
factory, warehouse, or establishment engaged in the manufacturing, 
processing, packing, or holding of food. Exempt from the registration 
requirement are farms, restaurants, other retail food establishments, 
nonprofit food establishments in which food is prepared for or served 
directly to the consumer, and fishing vessels (except those engaged in 
processing as defined in 21 CFR 123.3(k)). Foreign facilities required 
to register include only those from which food is exported to the 
United States without further processing or packaging outside the 
United States. The Bioterrorism Act provides that if food from an 
unregistered foreign facility is offered for import into the United 
States without having registered, the food will be held at the port of 
entry or at a secure facility, until the foreign facility has 
registered.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            02/03/03                     68 FR 5377
Interim Final Rule              10/10/03                    68 FR 58894
Interim Final Rule Comment 
Period Reopened                 03/00/04

Regulatory Flexibility Analysis Required: Yes

Government Levels Affected: None

Agency Contact: Leslye M. Fraser, Associate Director for Regulations, 
Office of Regulations and Policy, Department of Health and Human 
Services, Food and Drug Administration, Center for Food Safety and 
Applied Nutrition, 5100 Paint Branch Parkway, College Park, MD 20740
Phone: 301 436-2378
Fax: 301 436-2637
Email: [email protected]

RIN: 0910-AC40

[[Page 72888]]

_______________________________________________________________________




1025. PRIOR NOTICE OF IMPORTED FOOD UNDER THE PUBLIC HEALTH SECURITY AND 
BIOTERRORISM PREPAREDNESS AND RESPONSE ACT OF 2002

Priority: Economically Significant. Major under 5 USC 801.

Legal Authority: PL 107-188, sec 307

CFR Citation: 21 CFR 1.276 et seq

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

Abstract: This rulemaking is one of a number of actions being taken to 
improve FDA's ability to respond to threats of bioterrorism. Section 
801(m) of the Federal Food, Drug, and Cosmetic Act (FFDCA), which was 
added by section 307 of the Public Health Security and Bioterrorism 
Preparedness and Response Act of 2002, authorizes the Secretary, 
through FDA, to promulgate final regulations by December 12, 2003. 
Section 801(m) requires notification to FDA prior to the entry of 
imported food. The required prior notice would provide the identity of 
the article of food; the manufacturer; the shipper; the grower, if 
known at the time of notification; the originating country; the 
shipping country; and the anticipated port of entry. The regulation 
identifies the parties responsible for providing the notice and 
explains the information that the prior notice is required to contain, 
the method of submission of the notice, and the minimum and maximum 
period of advance notice required. Section 307 also states that if FDA 
does not receive prior notice or receives inadequate prior notice, the 
imported food shall be refused admission and held at the port of entry 
until proper notice is provided.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            02/03/03                     68 FR 5428
Interim Final Rule              10/10/03                    68 FR 58974
Interim Final Rule Comment 
Period Reopened                 03/00/04

Regulatory Flexibility Analysis Required: Yes

Government Levels Affected: Federal

Agency Contact: Mary Ayling, Lead, Inspection and Compliance Team, Food 
Safety Staff, Department of Health and Human Services, Food and Drug 
Administration, HFS-32, Center for Food Safety and Applied Nutrition, 
5100 Paint Branch Parkway, College Park, MD 20740
Phone: 301 436-2131
Fax: 301 436-2605
Email: [email protected]

RIN: 0910-AC41
_______________________________________________________________________




1026. REQUIREMENTS FOR LIQUID MEDICATED FEED AND FREE-CHOICE MEDICATED 
FEED

Priority: Substantive, Nonsignificant

Legal Authority: 21 USC 360b; 21 USC 371

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                            05/28/03                    68 FR 31645
Final Action                    09/00/04

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

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

RIN: 0910-AC43
_______________________________________________________________________




1027. 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                    06/00/04

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

RIN: 0910-AC44

[[Page 72889]]

_______________________________________________________________________




1028. BIOLOGICAL PRODUCTS; BACTERIAL VACCINES AND TOXOIDS; 
IMPLEMENTATION OF EFFICACY REVIEW

Priority: Substantive, Nonsignificant

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

CFR Citation: 21 CFR 201.59; 21 CFR 610.21

Legal Deadline: None

Abstract: The final rule amends the FDA biologics regulations in 
response to the report and recommendations of the Panel on Review of 
Bacterial Vaccines and Toxoids with Standards of Potency (the Panel). 
The Panel reviewed the safety, efficacy, and labeling of bacterial 
vaccines and toxoids with standards of potency, bacterial antitoxins, 
and immune globulins. On the basis of the Panel's findings and 
recommendations, FDA is classifying these products as Category I (safe, 
effective, and not misbranded), Category II (unsafe, ineffective, or 
misbranded), or Category IIIB (off the market pending completion of 
studies permitting a determination of effectiveness).

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/13/85                    50 FR 51002
NPRM Comment Period End         03/13/86
Final Action                    04/00/04

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

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

RIN: 0910-AC56
_______________________________________________________________________




1029. [bull] CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, 
PROCESSING, PACKING, OR HOLDING OF DRUGS; REVISION OF CERTAIN LABELING 
CONTROLS

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

Unfunded Mandates: Undetermined

Legal Authority: Not Yet Determined

CFR Citation: 21 CFR 211.122

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            07/29/97                    62 FR 40489
Final Action                    09/00/04

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected: Businesses

Government Levels Affected: None

Federalism:  Undetermined

Agency Contact: Howard P. Muller, Office of Regulatory Policy, 
Department of Health and Human Services, Food and Drug Administration, 
Suite 3037 (HFD-7), Center for Drug Evaluation and Research, 1451 
Rockville Pike, Rockville, MD 20852
Phone: 301 594-5601
Fax: 301 827-5562
Email: [email protected]

RIN: 0910-AF08
_______________________________________________________________________


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


Food and Drug Administration (FDA)



_______________________________________________________________________




1030. ELIGIBILITY DETERMINATION FOR DONORS OF HUMAN CELLS, TISSUES, AND 
CELLULAR AND TISSUE-BASED PRODUCTS

Priority: Other Significant

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

CFR Citation: 21 CFR 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 (HCT/Ps) to screen and test the donors of cells and tissues 
used in those products for evidence of, or risk factors for, relevant 
communicable disease. As part of this action, the agency is amending 
the current good manufacturing practice regulations that apply to HCT/
Ps regulated as drugs, medical devices, and/or biological products to 
incorporate the new donor eligibility 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

Agency Contact: Paula S. McKeever, Regulatory Policy Analyst, 
Department of Health and Human Services, Food

[[Page 72890]]

and Drug Administration, Suite 200N (HFM-17), Center for Biologics 
Evaluation and Research, 1401 Rockville Pike, Rockville, MD 20852-1448
Phone: 301 827-6210
Fax: 301 827-9434

RIN: 0910-AB27
_______________________________________________________________________




1031. CURRENT GOOD TISSUE PRACTICE FOR HUMAN CELL, TISSUE, AND CELLULAR 
AND TISSUE-BASED PRODUCTS ESTABLISHMENTS; 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 1270; 21 CFR 1271

Legal Deadline: None

Abstract: The Food and Drug Administration (FDA) is requiring human 
cell, tissue, and cellular and tissue-based products (HCT/P) 
establishments to follow current good tissue practice (CGTP), which 
governs the methods used in, and the facilities and controls used for, 
the manufacture of HCT/Ps, recordkeeping, and the establishment of a 
quality program. FDA is also issuing regulations pertaining to 
labeling, reporting, inspections, and enforcement.

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: No

Small Entities Affected: Businesses

Government Levels Affected: State

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

RIN: 0910-AB28
_______________________________________________________________________




1032. REQUIREMENTS FOR SUBMISSION OF IN VIVO BIOEQUIVALENCE DATA

Priority: Substantive, Nonsignificant

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

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

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            10/29/03                    68 FR 61640
Next Action Undetermined

Regulatory Flexibility Analysis Required: Yes

Government Levels Affected: None

Agency Contact: Aileen Ciampa, Regulatory Counsel, Department of Health 
and Human Services, Food and Drug Administration, HFD-7, Center for 
Drug Evaluation and Research, 1451 Rockville Pike, Rockville, MD 20857
Phone: 301 594-2041
Fax: 301 827-5562

RIN: 0910-AC23
_______________________________________________________________________




1033. [bull] FOOD LABELING: FOOD ALLERGEN INGREDIENT LABELING

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

Legal Authority: 21 USC 321 ; 21 USC 331; 21 USC 342; 21 USC 343; 21 
USC 371

CFR Citation: 21 CFR 101

Legal Deadline: None

Abstract: The purpose of this rulemaking is to reduce mortality and 
morbidity by providing sensitive individuals with additional food 
allergen information to help them protect themselves from serious 
allergic reactions, including life-threatening anaphylactic shock. The 
eight most common food allergens are: 1) peanuts; 2) soybeans; 3) milk; 
4) eggs; 5) fish; 6) crustacea (e.g., lobster, crab, shrimp); 7) tree 
nuts (e.g., almonds, chestnuts, macadamia nuts, pecans, walnuts, 
hazelnuts or filberts, cashews, brazil nuts, pistachios, pine nuts); 
and 8) wheat. The rule would propose to require that foods that contain 
certain protein ingredients include information on the label in plain 
English terms that clearly identifies the presence of these 
ingredients.
The agency is also proposing to require food allergen labeling on 
spices, flavors, noncertified colors and incidental additives found in 
foods as ingredients that contain certain allergic proteins. Currently, 
section 403(i) of the Federal Food, Drug, and Cosmetic Act allows 
spices, flavors and noncertified colors used as ingredients of foods to 
be declared collectively on the label without naming each one. Federal 
regulations at 21 C.F.R. 101.100(a)(3) exempt incidental additives from 
ingredient declaration on the label if they are present in the food at 
an insignificant amount and do not have any technical or functional 
effect in the finished food.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                             To Be                       Determined

Regulatory Flexibility Analysis Required: Yes

Government Levels Affected: None

Federalism:  Undetermined

Agency Contact: Rhonda Rhoda Kane M.S., R.D., Consumer Safety Officer, 
Department of Health and Human Services, Food and Drug Administration, 
HFS-820, Center for Food Safety and Applied Nutrition, 5100 Paint 
Branch Parkway, College Park, MD 20740
Phone: 301 436-2371
Fax: 301 436-2636
Email: [email protected]

RIN: 0910-AF07

[[Page 72891]]

_______________________________________________________________________


Department of Health and Human Services (HHS)         Completed Actions


Food and Drug Administration (FDA)



_______________________________________________________________________




1034. INVESTIGATIONAL USE NEW ANIMAL DRUG REGULATIONS

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

Legal Authority: 21 USC 321; 21 USC 351 to 353; 21 USC 360b; 21 USC 371

CFR Citation: 21 CFR 511

Legal Deadline: None

Abstract: FDA initiated a review of 21 C.F.R. 511.1 under section 610 
of the Regulatory Flexibility Act. The purpose of the section 610 
review was to determine if the rule should be amended to minimize 
adverse economic impacts on small entities. FDA solicited and 
considered 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                      06/02/03

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Marty Schoenemann, Department of Health and Human 
Services, Food and Drug Administration, HFV-126, HFV-100, Center for 
Veterinary Medicine, 7500 Standish Place, Rockville, MD 20855
Phone: 301 827-0220

RIN: 0910-AB02
_______________________________________________________________________




1035. FOOD LABELING: TRANS FATTY ACIDS IN NUTRITION LABELING, NUTRIENT 
CONTENT CLAIMS, AND HEALTH CLAIMS

Priority: Economically Significant. Major under 5 USC 801.

CFR Citation: 21 CFR 101

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Rule                      07/11/03                    68 FR 41434

Regulatory Flexibility Analysis Required: Yes

Government Levels Affected: Local, State, Tribal

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

Agency Contact: Julie Schrimpf
Phone: 301 436-2373
Fax: 301 436-2639
Email: [email protected]

RIN: 0910-AB66
_______________________________________________________________________




1036. ALUMINUM IN LARGE- AND SMALL-VOLUME PARENTERALS USED IN TOTAL 
PARENTERAL NUTRITION

Priority: Other Significant

CFR Citation: 21 CFR 201.323(c)

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    06/03/03                    68 FR 32979

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: None

Agency Contact: Christine F. Rogers
Phone: 301 594-2041
Fax: 301 827-5562

RIN: 0910-AC18
_______________________________________________________________________




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

Priority: Substantive, Nonsignificant

CFR Citation: 21 CFR 500.80; 21 CFR 500.82; 21 CFR 500.84; 21 CFR 
500.88

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    12/23/02                    67 FR 78172

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Steven Brynes
Phone: 301 827-6975
Email: [email protected]

RIN: 0910-AC45
_______________________________________________________________________




1038. 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

Priority: Economically Significant. Major under 5 USC 801.

CFR Citation: 21 CFR 314.52(a)(3); 21 CFR 314.53(b); 21 CFR 
314.53(c)(1); 21 CFR 314.53(c)(2); 21 CFR 314.95(a)(3)

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Rule                      06/18/03                    68 FR 36676

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Jarilyn Dupont
Phone: 301 827-3360
Fax: 301 594-6777
Email: [email protected]

RIN: 0910-AC48

[[Page 72892]]

_______________________________________________________________________


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


Health Resources and Services Administration (HRSA)



_______________________________________________________________________




1039. NATIONAL PRACTITIONER DATA BANK FOR ADVERSE INFORMATION ON 
PHYSICIANS AND OTHER HEALTH CARE PRACTITIONERS: MEDICAL MALPRACTICE 
PAYMENTS REPORTING REQUIREMENTS

Priority: Substantive, Nonsignificant

Legal Authority: 42 USC 11131

CFR Citation: 45 CFR 60.7

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/24/98                    63 FR 71255
Second NPRM                     04/00/04

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, Health Resources and 
Services Administration, Suite 300, 7519 Standish Place, Rockville, MD 
20957
Phone: 301 443-2300
Fax: 301 443-6725

RIN: 0906-AA41
_______________________________________________________________________




1040. DESIGNATION OF MEDICALLY UNDERSERVED POPULATIONS AND HEALTH 
PROFESSIONAL SHORTAGE AREAS

Priority: Substantive, Nonsignificant

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

CFR Citation: 42 CFR 5; 42 CFR 51c

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/01/98                    63 FR 46538
Second NPRM                     04/00/04

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, Room 8C26, National Center for Health Workforce 
Analysis, Bureau of Health Professions, Parklawn Building, Rockville, 
MD 20857
Phone: 301 594-0197
Email: [email protected]

RIN: 0906-AA44
_______________________________________________________________________


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


Health Resources and Services Administration (HRSA)



_______________________________________________________________________




1041. [bull] INTERIM FINAL RULE FOR THE SMALLPOX EMERGENCY PERSONNEL 
PROTECTION PROGRAM: SMALLPOX (VACCINIA) VACCINE INJURY TABLE

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

Legal Authority: PL 108-20, 117 Stat 638

CFR Citation: 42 CFR 102

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              08/27/03                    68 FR 51492
Final Action                    03/00/04

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Dr. Vito Caserta, Chief Medical Officer, Department of 
Health and Human Services, Health Resources and Services 
Administration, 10th Floor, 4350 East West Highway, Bethesda, MD 20814
Phone: 301 443-4956
Email: [email protected]

RIN: 0906-AA60
_______________________________________________________________________




1042. [bull] SMALLPOX VACCINE INJURY COMPENSATION PROGRAM: 
ADMINISTRATIVE IMPLEMENTATION

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

RIN: 0906-AA61

[[Page 72893]]

_______________________________________________________________________


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


Health Resources and Services Administration (HRSA)



_______________________________________________________________________




1043. NATIONAL PRACTITIONER DATA BANK FOR ADVERSE INFORMATION ON 
PHYSICIANS AND OTHER HEALTH CARE PRACTITIONERS: REPORTING ADVERSE AND 
NEGATIVE ACTIONS

Priority: Substantive, Nonsignificant

Legal Authority: 42 USC 1396r-2

CFR Citation: 45 CFR 60

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                             To Be                       Determined

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, Health Resources and 
Services Administration, Suite 300, 7519 Standish Place, Rockville, MD 
20957
Phone: 301 443-2300
Fax: 301 443-6725

RIN: 0906-AA57
_______________________________________________________________________


Department of Health and Human Services (HHS)         Completed Actions


Indian Health Service (IHS)



_______________________________________________________________________




1044. INDIAN CHILD PROTECTION AND FAMILY VIOLENCE PREVENTION ACT MINIMUM 
STANDARDS OF CHARACTER

Priority: Info./Admin./Other

CFR Citation: 42 CFR 36

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn                       11/18/03

Regulatory Flexibility Analysis Required: No

Government Levels Affected: Tribal

Agency Contact: Ramona D. Williams
Phone: 301 443-1589

RIN: 0917-AA02
_______________________________________________________________________


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


National Institutes of Health (NIH)



_______________________________________________________________________




1045. 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 NIH. For each year of scholarship support, the recipient 
agrees to service (employment) after graduation, at NIH, for one year. 
Additionally, the individual agrees to at least 10 consecutive weeks of 
service (employment) at 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                            03/00/04

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-AA10
_______________________________________________________________________




1046. NATIONAL INSTITUTES OF HEALTH TRAINING GRANTS

Priority: Substantive, Nonsignificant

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

CFR Citation: 42 CFR 63a

Legal Deadline: None

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

[[Page 72894]]

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            03/00/04

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
_______________________________________________________________________




1047. STANDARDS FOR A NATIONAL CHIMPANZEE SANCTUARY SYSTEM

Priority: Substantive, Nonsignificant

Legal Authority: 42 USC 287a-3a

CFR Citation: 42 CFR 9

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

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            03/00/04

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
_______________________________________________________________________




1048. NATIONAL INSTITUTES OF HEALTH 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                            03/00/04

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
_______________________________________________________________________




1049. NATIONAL INSTITUTES OF HEALTH EXTRAMURAL LOAN REPAYMENT PROGRAM 
FOR CLINICAL RESEARCHERS

Priority: Substantive, Nonsignificant

Legal Authority: 42 USC 216; 42 USC 288-5a

CFR Citation: 42 CFR 68g

Legal Deadline: None

Abstract: NIH proposes to establish implementing regulations for the 
Extramural Loan Repayment Program for Clinical Researchers, authorized 
under section 487F of the Public Health Service Act. The program 
provides for the repayment of the existing educational loan debt of 
qualified health professionals who agree to conduct clinical research.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            03/00/04

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-AA33
_______________________________________________________________________




1050. NATIONAL INSTITUTES OF HEALTH PEDIATRIC RESEARCH LOAN REPAYMENT 
PROGRAM

Priority: Substantive, Nonsignificant

Legal Authority: 42 USC 216; 42 USC 288-6

CFR Citation: 42 CFR 68e

Legal Deadline: None

Abstract: NIH proposes to establish implementing regulations for 
Pediatric Research Loan Repayment Program, authorized under section 
487F of the Public Health Service Act. The program provides for the 
repayment of the existing educational loan debt of qualified health 
professionals who agree to conduct pediatric research.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            03/00/04

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-AA34
_______________________________________________________________________




1051. NATIONAL INSTITUTES OF HEALTH LOAN REPAYMENT PROGRAM FOR HEALTH 
DISPARITIES RESEARCH

Priority: Substantive, Nonsignificant

Legal Authority: 42 USC 216; 42 USC 287c-33

CFR Citation: 42 CFR 68f

Legal Deadline: None

[[Page 72895]]

Abstract: NIH proposes to establish implementing regulations for the 
Loan Repayment Program for Health Disparities Research, authorized 
under section 485G of the Public Health Service Act. The program 
provides for the repayment of the existing educational loan debt of 
qualified health professionals who agree to conduct minority-health or 
other health-disparities research for a minimum of two years.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            03/00/04

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-AA35
_______________________________________________________________________




1052. NATIONAL INSTITUTES OF HEALTH CLINICAL RESEARCH LOAN REPAYMENT 
PROGRAM FOR INDIVIDUALS FROM DISADVANTAGED BACKGROUNDS

Priority: Substantive, Nonsignificant

Legal Authority: 42 USC 216; 42 USC 288-5

CFR Citation: 42 CFR 68a

Legal Deadline: None

Abstract: NIH proposes to amend the regulations governing the Clinical 
Research Loan Repayment Program for Individuals from Disadvantaged 
Backgrounds to reflect the new maximum annual loan amount of $35,000 
and a change in program eligibility to include qualified health 
professionals who are not NIH employees, as well as to amend the 
definition of ``disadvantaged.''

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            03/00/04

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-AA36
_______________________________________________________________________




1053. [bull] NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT 
CONTRACEPTION AND INFERTILITY RESEARCH LOAN REPAYMENT PROGRAM

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

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

CFR Citation: 42 CFR 68c

Legal Deadline: None

Abstract: NIH proposes to amend its current regulations governing the 
National Institute of Child Health and Human Development Contraception 
and Infertility Research Loan Repayment Program to make the eligibility 
requirements of the Program consistent with the eligibility 
requirements of the other extramural loan repayment programs 
administered by NIH.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            03/00/04

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-AA41
_______________________________________________________________________


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


National Institutes of Health (NIH)



_______________________________________________________________________




1054. 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                      03/00/04

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 72896]]

_______________________________________________________________________




1055. 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 found ambiguities, misstatements, and voids in 
the existing peer review 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 Rule                      03/00/04

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
_______________________________________________________________________




1056. NATIONAL INSTITUTES OF HEALTH CENTER GRANTS

Priority: Substantive, Nonsignificant

Legal Authority: 42 USC 216; 42 USC 284g; 42 USC 285a-6(c)(1)(E); 42 
USC 285a-7(c)(1)(G); 42 USC 285b-4; 42 USC 285c-5; 42 USC 285c-8; 42 
USC 285d-6; 42 USC 285e-2; 42 USC 285e-3; 42 USC 285e-10a; . . .

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. 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                            11/12/02                    67 FR 68548
Final Rule                      03/00/04

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
_______________________________________________________________________


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


Office of Public Health and Science (OPHS)



_______________________________________________________________________




1057. PUBLIC HEALTH SERVICE 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                            12/00/03
NPRM Comment Period End         02/00/04

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Chris Pascal, Director, Office of Research Integrity, 
Department of Health and Human Services, Office of Public Health and 
Science, Suite 750, 1101 Wootten Parkway, Rockville, MD 20852
Phone: 301 443-3400
Fax: 301 443-5351

RIN: 0940-AA04
_______________________________________________________________________




1058. 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

[[Page 72897]]

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/00/03
NPRM Comment Period End         03/00/04

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Irene Stith-Coleman Ph.D, Department of Health and 
Human Services, Office of Public Health and Science, Suite 200, The 
Tower Building, 1101 Wootten Parkway, Rockville, MD 20852
Phone: 301 496-7005
Fax: 301 402-0527

RIN: 0940-AA06
_______________________________________________________________________




1059. HUMAN SUBJECTS PROTECTION REGULATIONS: TRAINING AND EDUCATION 
REQUIREMENTS FOR INSTITUTIONAL OFFICIALS, INSTITUTIONAL REVIEW BOARD 
MEMBERS AND STAFF, HUMAN PROTECTIONS ADMINISTRATORS, AND INVESTIGATOR

Priority: Other Significant

Legal Authority: 5 USC 301; 42 USC 289

CFR Citation: 45 CFR 46

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            03/00/04
NPRM Comment Period End         06/00/04

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Michael A. Carome MD, Department of Health and Human 
Services, Office of Public Health and Science, Suite 200, The Tower 
Building, 1101 Wootten Parkway, Rockville, MD 20852
Phone: 301 496-7005
Fax: 301 402-0527

RIN: 0940-AA08
_______________________________________________________________________


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


Office of Public Health and Science (OPHS)



_______________________________________________________________________




1060. 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                    06/00/04

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Chris Pascal, Director, Office of Research Integrity, 
Department of Health and Human Services, Office of Public Health and 
Science, Suite 750, 1101 Wootten Parkway, Rockville, MD 20852
Phone: 301 443-3400

[[Page 72898]]

Fax: 301 443-5351

RIN: 0940-AA01
_______________________________________________________________________


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


Centers for Medicare & Medicaid Services (CMS)



_______________________________________________________________________




1061. END STAGE RENAL DISEASE (ESRD) CONDITIONS FOR COVERAGE (CMS-3818-
P)

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

RIN: 0938-AG82
_______________________________________________________________________




1062. HOSPITAL CONDITIONS OF PARTICIPATION: REQUIREMENTS FOR APPROVAL 
AND REAPPROVAL OF TRANSPLANT CENTERS TO PERFORM ORGAN TRANSPLANTS (CMS-
3835-P)

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

RIN: 0938-AH17
_______________________________________________________________________




1063. 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 revises 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

________________________________________________________________________

NPRM                            04/00/04

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, Office of Clinical Standards and Quality, 7500 
Security Boulevard, Baltimore, MD 21244
Phone: 410 786-6051

Danielle Shearer, Health Insurance Specialist, Department of Health and 
Human Services, Centers for Medicare & Medicaid Services, Office of 
Clinical Standards and Quality, 7500 Security Boulevard, Baltimore, MD 
21244
Phone: 410 786-6617

RIN: 0938-AH27
_______________________________________________________________________




1064. SUPPLIER STANDARDS FOR HOME OXYGEN, THERAPEUTIC SHOES, AND 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 implement certain provisions in the 
statute relating to suppliers of durable medical equipment, 
prosthetics, orthotics, and supplies and establish service standards 
for suppliers of home oxygen equipment and therapeutic shoes home 
nutrition therapy. Establishing these standards would ensure that 
suppliers are qualified to provide the appropriate health care services 
and help safeguard the Medicare program and its beneficiaries from any 
instances of fraudulent or abusive billing practices.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            08/00/04

Regulatory Flexibility Analysis Required: Yes

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, Center for Medicaid and State Operations, 7500 Security 
Boulevard, C3-02-16, Baltimore, MD 21244
Phone: 410 786-1302

RIN: 0938-AJ98
_______________________________________________________________________




1065. HEALTH INSURANCE REFORM: CLAIMS ATTACHMENTS STANDARDS (CMS-0050-P)

Priority: Other Significant. Major under 5 USC 801.

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

Legal Authority: 42 USC 1320d-2(a)(2)(B)

CFR Citation: 45 CFR 162

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

Abstract: This rule proposes an electronic standard for claims 
attachments. The standard is required by the Health Insurance 
Portability and Accountability Act of 1996. It would be used to 
transmit clinical data, in addition to those data contained in the 
claims standard, to help establish medical necessity for coverage.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            08/00/04

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: Federal, Local, State, Tribal

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

Agency Contact: James Krall, Health Insurance Specialist, Department of 
Health and Human Services, Centers for Medicare & Medicaid Services, 
Office of Health Insurance Portability and Account Act Standards, 7500 
Security Boulevard, Baltimore, MD 21244
Phone: 410 786-6999

RIN: 0938-AK62

[[Page 72899]]

_______________________________________________________________________




1066. ORGAN PROCUREMENT ORGANIZATION CONDITIONS FOR COVERAGE (CMS-3064-
P)

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

RIN: 0938-AK81
_______________________________________________________________________




1067. 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. 58 in part II of this issue of 
the Federal Register.

RIN: 0938-AL26
_______________________________________________________________________




1068. PROSPECTIVE PAYMENT SYSTEM FOR INPATIENT PSYCHIATRIC FACILITIES FY 
2004 (CMS-1213-F)

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

RIN: 0938-AL50
_______________________________________________________________________




1069. PROVIDER REIMBURSEMENT DETERMINATIONS AND APPEALS (CMS-1727-P)

Priority: Substantive, Nonsignificant

Legal Authority: Sec 1878 of the Social Security Act

CFR Citation: 42 CFR 405

Legal Deadline: None

Abstract: This proposed rule would redefine, clarify, and update the 
guidelines and procedures for Provider Reimbursement Review Board 
appeals, based on recent court decisions.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/00/04

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Morton Marcus, Heal Insurance Specialist, Department of 
Health and Human Services, Centers for Medicare & Medicaid Services, 
7500 Security Boulevard, C4-25-02, Baltimore, MD 21244
Phone: 410 786-4477

RIN: 0938-AL54
_______________________________________________________________________




1070. HEALTH COVERAGE PORTABILITY'S REQUEST FOR INFORMATION ON BENEFIT--
SPECIFIC WAITING PERIODS (CMS-2150-NC)

Priority: Info./Admin./Other

Legal Authority: Not Yet Determined

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

________________________________________________________________________

NPRM                            05/00/04

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, Center for Medicaid and State Operations, 7500 Security 
Boulevard, S3-16-26, Baltimore, MD 21244
Phone: 410 786-6851

RIN: 0938-AL64
_______________________________________________________________________




1071. DMERC SERVICE AREAS AND RELATED MATTERS (CMS-1219-P)

Priority: Substantive, Nonsignificant

Legal Authority: Sec 1842 of the Social Security Act; Sec 1834(a)(12) 
of the Social Security Act; Sec 1834(h)(3) of the Social Security Act; 
Sec 1834(j)(E) of the Social Security Act

CFR Citation: 42 CFR 421.210

Legal Deadline: None

Abstract: This proposed rule would allow flexibility in making changes 
to the Durable Medical Equipment Regional Carrier contractor structure.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            04/00/04

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Kim Nyland, Health Insurance Specialist, Department of 
Health and Human Services, Centers for Medicare & Medicaid Services, 
S1-14-27, Center for Medicare Management, 7500 Security Boulevard, S1-
14-27, Baltimore, MD 21244
Phone: 410 786-2289

RIN: 0938-AL76
_______________________________________________________________________




1072. 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

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/00/04

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, 
Office of Clinical Standards and Quality, 7500 Security Boulevard, 
Baltimore, MD 21244
Phone: 410 786-5526

Jacqueline Morgan, Health Insurance Specialist, Department of Health 
and Human Services, Centers for Medicare & Medicaid Services, S3-02-01, 
Office of Clinical Standards and Quality, 7500 Security Boulevard, 
Baltimore, MD 21244
Phone: 410 786-4282

RIN: 0938-AL80

[[Page 72900]]

_______________________________________________________________________




1073. 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 proposed 
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

________________________________________________________________________

NPRM                            05/00/04

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, Center for Medicaid and State Operations, 7500 Security 
Boulevard, S3-16-26, Baltimore, MD 21244
Phone: 410 786-6851

RIN: 0938-AL88
_______________________________________________________________________




1074. 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: Sec 1861(s)(2)(B) of the Social Security Act

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

________________________________________________________________________

NPRM                            08/00/04

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected: No

Government Levels Affected: Undetermined

Federalism:  Undetermined

Agency Contact: Angela Mason, Health Insurance Specialist, Department 
of Health and Human Services, Centers for Medicare & Medicaid Services, 
Center for Medicaid and State Operations, 7500 Security Boulevard, C4-
05-17, Baltimore, MD 21244
Phone: 410 786-7452

RIN: 0938-AM13
_______________________________________________________________________




1075. PROCEDURES FOR MAINTAINING CODE LISTS IN THE NEGOTIATED NATIONAL 
COVERAGE DETERMINATIONS FOR CLINICAL DIAGNOSTIC LABORATORY SERVICES 
(CMS-3119-PN)

Priority: Other Significant

Legal Authority: 42 USC 1395h(a); 42 USC 1395e; 42 USC 1395u(a); 42 USC 
1395x; 42 USC 1395y(a)(1)(A); 42 USC 1395y(a)(7)

CFR Citation: Not Yet Determined

Legal Deadline: None

Abstract: This proposed notice would establish the procedures to be 
used for maintaining the lists of codes that were included in the 
national coverage determinations announced in the Federal Register on 
November 25, 2001 (66 FR 58788). It would also clarify the date of 
service provisions related to archived speciments from that same final 
rule.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            01/00/04

Regulatory Flexibility Analysis Required: No

Government Levels Affected: Undetermined

Agency Contact: Jacqueline Sheridan, Health Insurance Specialist, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, Office of Clinical Standards and Quality, 7500 
Security Boulevard, C1-09-06, Baltimore, MD 21244
Phone: 410 786-4635

RIN: 0938-AM36
_______________________________________________________________________




1076. HOSPITAL PATIENTS' RIGHTS COP-STANDARD SAFETY COMPLIANCE 
COMMITTEES (CMS-3120-P)

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

RIN: 0938-AM39
_______________________________________________________________________




1077. PROSPECTIVE PAYMENT SYSTEM AND CONSOLIDATED BILLING FOR SKILLED 
NURSING FACILITIES--UPDATE FOR FY 2005 (CMS-1249-N)

Priority: Other Significant. Major under 5 USC 801.

Legal Authority: Sec 1888(e) of the Social Security Act

CFR Citation: 42 CFR 413.330 to 413.350

Legal Deadline: NPRM, Statutory, July 30, 2004, NPRM.

Abstract: This annual proposed rule updates the payment rates used 
under the skilled nursing facilities prospective payment system 
beginning October 1, 2004.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Notice                          06/00/04

Regulatory Flexibility Analysis Required: Yes

Government Levels Affected: None

Agency Contact: William Ullman, Health Insurance Specialist, Department 
of Health and Human Services, Centers for Medicare & Medicaid Services, 
C4-13-15, Center for Medicaid and State Operations, 7500 Security 
Boulevard, C5-07-08, Baltimore, MD 21244
Phone: 401 786-5667

RIN: 0938-AM46
_______________________________________________________________________




1078. MODIFICATIONS TO ELECTRONIC TRANSACTIONS AND CODE SETS (CMS-0009-
P)

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

Unfunded Mandates: Undetermined

[[Page 72901]]

Legal Authority: Social Security Act, sec 1171 to 1179

CFR Citation: 42 CFR 162.1002; 42 CFR 162.1802

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/00/04

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected: Businesses, Governmental Jurisdictions, 
Organizations

Government Levels Affected: Federal, Local, State, Tribal

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

Agency Contact: Stanley B. Nachimson, Senior Technical Advisor, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, N2-16-03, 7500 Security Boulevard, Baltimore, MD 
21244
Phone: 410 786-6153

RIN: 0938-AM50
_______________________________________________________________________




1079. REVISED CIVIL MONEY PENALTIES, ASSESSMENTS, EXCLUSIONS, AND 
RELATED APPEALS PROCEDURES (CMS-6146-P)

Priority: Other Significant

Unfunded Mandates: Undetermined

Legal Authority: PL 97-35, sec 2105; PL 104-191, sec 231(C); PL 105-33, 
sec 4311(b); PL 105-33, sec 4317; PL 105-33, sec 4031(a)(2); PL 105-33, 
sec 4531(b)(2)

CFR Citation: 42 CFR 402, subpart C

Legal Deadline: None

Abstract: This rule proposes revisions to the CMS civil money penalty 
authorities. These proposed revisions are intended to add the specific 
exclusion sanction authorities as established in the procedures for 
imposing civil money penalties, assessments, and exclusions for certain 
violations of the Medicare and Medicaid programs.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/00/04

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Joel Cohen, Office of Financial Management, Department 
of Health and Human Services, Centers for Medicare & Medicaid Services, 
C3-04-06, 7500 Security Boulevard, Baltimore, MD 21244-1850
Phone: 410 786-3349

RIN: 0938-AM54
_______________________________________________________________________




1080. REQUIREMENTS FOR NURSING HOMES TO IDENTIFY THE NUMBER OF LICENSED 
AND UNLICENSED NURSES (CMS-3121-P)

Priority: Other Significant

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

CFR Citation: 42 CFR 483

Legal Deadline: None

Abstract: This proposed rule will implement section 941 of the Benefits 
Improvement and Protection Act of 2000, which requires nursing homes to 
post daily, for each shift, the number of licensed and unlicensed 
nursing staff directly responsible for resident care.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            02/00/04

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

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: 410 786-0596

RIN: 0938-AM55
_______________________________________________________________________




1081. [bull] CHANGES TO THE HOSPITAL OUTPATIENT PROSPECTIVE SYSTEM AND 
CALENDAR YEAR 2005 PAYMENT RATES (CMS-1427-P)

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

Legal Authority: 42 USC 1935L; Balanced Budget Act of 1997; Medicare, 
Medicaid and SCHIP Balanced Budget Refinement Act of 1999; Medicare, 
Medicaid, and SCHIP Benefits Improvement and Protection Act of 2000

CFR Citation: Not Yet Determined

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

Abstract: The proposed rule would revise the Medicare hospital 
outpatient prospective payment system beginning January 1, 2005. (The 
statute requires that this proposed rule and subsequent final rule be 
published by November 1, 2004.)

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/00/04

Regulatory Flexibility Analysis Required: Yes

Government Levels Affected: Federal

Agency Contact: Cindy Read, Division Director, Department of Health and 
Human Services, Centers for Medicare & Medicaid Services, Center for 
Medicare Mangement, 7500 Security Boulevard, C4-05-07, Baltimore, MD 
21244
Phone: 410 786-1852

RIN: 0938-AM75
_______________________________________________________________________




1082. [bull] CHANGES TO THE HOSPITAL INPATIENT PROSPECTIVE PAYMENT 
SYSTEM AND FY 2005 RATES (CMS-1428-P)

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

Legal Authority: Sec 1886(d) of the Social Security Act

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

Legal Deadline: NPRM, Statutory, April 1, 2004, NPRM.
Final, Statutory, August 1, 2004, Final.

Abstract: We would revise the Medicare acute hospital inpatient 
prospective payment system for operating and capital-related costs to

[[Page 72902]]

implement changes arising from our continuing experience with these 
systems. In addition, in the Addendum, we describe changes to the 
amounts and factors used to determine the rates for Medicare hospital 
inpatient services for operating costs and capital-related costs. These 
changes apply to discharges on or after October 1, 2004. We also set 
forth proposed rate-of-increase limits as well as proposed policy 
changes for hospitals and hospital units excluded from the prospective 
payments systems. (The statute requires that this proposed and 
subsequent final rule be published by August 1, 2004.)

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            07/00/04

Regulatory Flexibility Analysis Required: Yes

Government Levels Affected: Federal

Agency Contact: Tzvi Hefter, Director, Division of Acute Care, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, C4-07-07, Center for Medicare Management, 7500 
Security Boulevard, C4-07-07, Baltimore, MD 21244
Phone: 410 786-4487

RIN: 0938-AM80
_______________________________________________________________________




1083. [bull] COVERED OUTPATIENT DRUGS UNDER THE MEDICAID DRUG REBATE 
PROGRAM (CMS-2174-P)

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

Unfunded Mandates: Undetermined

Legal Authority: Social Security Act, sec 1905 (a) (12); Social 
Security Act, sec 1903 (a); Social Security Act, sec 1902 (a) (54); 
Social Security Act, sec 1903 (i) (10); Social Security Act, sec 1927; 
. . .

CFR Citation: 42 CFR 441 ; 42 CFR 447

Legal Deadline: None

Abstract: This proposed rule will repropose and request public comments 
on numerous provisions related to the Medicaid drug rebate program. The 
agency published a proposed rule on September 19, 1995. However, in 
light of new issues, the agency seeks an opportunity to propose new 
provisions and seeks comments.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            08/00/04

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected: Undetermined

Government Levels Affected: Undetermined

Federalism:  Undetermined

Agency Contact: Marge Watchorn, Health Insurance Specialist, Department 
of Health and Human Services, Centers for Medicare & Medicaid Services, 
Center for Medicaid and State Operations, 7500 Security Boulevard, S2-
05-16, Baltimore, MD 21244
Phone: 410 786-4361

RIN: 0938-AM81
_______________________________________________________________________




1084. [bull] PROSPECTIVE PAYMENT SYSTEM FOR INPATIENT REHABILITATION 
FACILITIES FOR FY 2005 (CMS-1360-P)

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

Legal Authority: Sec 1886(j) of the Social Security Act; PL 105-33; PL 
106-554; PL 106-113

CFR Citation: 42 CFR 412; 42 CFR 413

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

Abstract: This proposed rule would update rates for the prospective 
payment system for inpatient rehabilitation facilities for FY 2005. 
(The statute requires that the subsequent final rule be published by 
August 1, 2004.)

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            05/00/04
Final Action                    07/00/04

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Robert Kuhl, Division Director, Department of Health 
and Human Services, Centers for Medicare & Medicaid Services, C4-11-06, 
Center for Medicare Management, 7500 Security Boulevard, C5-06-24, 
Baltimore, MD 21244
Phone: 410 786-4597

RIN: 0938-AM82
_______________________________________________________________________




1085. [bull] PROSPECTIVE PAYMENT SYSTEM FOR LONG-TERM CARE HOSPITALS: 
ANNUAL PAYMENT RATE UPDATES AND POLICY CHANGES (EFFECTIVE 7/1/04) (CMS-
1263-P)

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

Unfunded Mandates: Undetermined

Legal Authority: Sec 123 of BBRA 1999; Sec 307(b) of BIPA 2000

CFR Citation: 42 CFR 412 ; 42 CFR 413

Legal Deadline: Final, Statutory, April 30, 2004, Final.

Abstract: This rule proposes the payment rate update for the 2005 
prospective payment system for Medicare long-term care hospitals. The 
new rates will be based on cost reports from the first long-term care 
prospective payment system rate year. (The final rule must be published 
by April 30, 2004, to be effective July 1, 2004.)

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            04/00/04

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected: Businesses

Government Levels Affected: Undetermined

Agency Contact: Tzvi Hefter, Director, Division of Acute Care, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, C4-07-07, Center for Medicare Management, 7500 
Security Boulevard, C4-07-07, Baltimore, MD 21244
Phone: 410 786-4487

RIN: 0938-AM84
_______________________________________________________________________




1086. [bull] PAYMENT ERROR RATE MEASUREMENT (PERM) PROGRAM (CMS-2186-P)

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

Legal Authority: Sections 1902 (a)(6) of the Social Security Act; Sec 
2107 (b)(1) of the Social Security Act; Improper Payments Information 
Act of 2002 (IPIA) (Public Law 107-300)

CFR Citation: None

Legal Deadline: None

Abstract: Sections 1902(a)(6)and 2107(b)(1) of the Act, governing

[[Page 72903]]

Medicaid and SCHIP, respectively, require States to provide to the 
Secretary information to monitor program performance. This rule would 
require States under the current statutory provisions and the IPIA and 
through this regulation to estimate improper payments using the CMS 
PERM methodolgy for the reporting year in the Medicaid and SCHIP 
programs. The States are further required to submit payment error rates 
to CMS for the purpose of calculating a natinal level payment error 
rate as required by the IPIA.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            05/00/04

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: State

Federalism:  Undetermined

Agency Contact: Wayne Alden Slaughter, Department of Health and Human 
Services, Centers for Medicare & Medicaid Services, 7500 Security 
Boulevard, S3-13-15, Baltimore, MD 21244
Phone: 410 786-0038

RIN: 0938-AM86
_______________________________________________________________________




1087. [bull] REQUIREMENTS FOR long-term CARE FACILITIES: HOSPICE 
SERVICES (CMS-3140-P)

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

Unfunded Mandates: Undetermined

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

CFR Citation: 42 CFR 483

Legal Deadline: None

Abstract: This proposed rule will clarify the hospice care of residents 
in long-term care facilities. This rule will reflect the changes in the 
hospice proposed rule (CMS-3844-P, 42 CFR 418) that is to reflect the 
interdisciplinary view of resident care and improve the quality of 
healthcare furnished through the Medicare and Medicaid programs reflect 
the interdisciplinary view of resident care and improve the quality of 
health care furnished through the Medicare and Medicaid programs.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/00/04

Regulatory Flexibility Analysis Required: Yes

Government Levels Affected: Undetermined

Federalism:  Undetermined

Agency Contact: Anita Panicker, Health Insurance Specialist, Department 
of Health and Human Services, Centers for Medicare & Medicaid Services, 
7500 Security Bloulevard, S3-04-26, Baltimore, MD 21244
Phone: 410 786-5646

RIN: 0938-AM87
_______________________________________________________________________




1088. [bull] REVISIONS TO PAYMENT POLICIES UNDER THE PHYSICIAN FEE 
SCHEDULE FOR CALENDAR YEAR 2005 (CMS-1429-P)

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

Legal Authority: 42 USC 1395W-4

CFR Citation: 42 CFR 410; 42 CFR 414

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

Abstract: This rule would make several changes affecting Medicare part 
B payment. (The statute requires that the final rule be published by 
November 1, 2004.)

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/00/04

Regulatory Flexibility Analysis Required: Yes

Government Levels Affected: Federal

Agency Contact: Latesha Walker, Health Insurance Specialist, Department 
of Health and Human Services, Centers for Medicare & Medicaid Services, 
Center for Medicare Management, 7500 Security Boulevard, Baltimore, MD 
21244
Phone: 410 786-1101

RIN: 0938-AM90
_______________________________________________________________________




1089. [bull] HOME HEALTH PROSPECTIVE PAYMENT SYSTEM RATE UPDATE FY 2005 
(CMS-1265-P)

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

Legal Authority: 42 USC 1395ff

CFR Citation: None

Legal Deadline: None

Abstract: This proposed rule would set forth an update to the 60-day 
national episode rates and the national per-visit amounts under the 
Medicare prospective payment system for home health agencies. As part 
of this proposed rule, we are proposing to rebase and revise the home 
health market basket to reflect total cost and modifying certain 
variables for some of the cost categories. (The proposed and final 
rules must be published by July 1, 2004, to allow three months for 
systems changes.)

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            01/00/04

Regulatory Flexibility Analysis Required: Yes

Government Levels Affected: None

Agency Contact: Randy Throndset, Department of Health and Human 
Services, Centers for Medicare & Medicaid Services, 7500 Security 
Boulevard, Baltimore, MD 21244
Phone: 410 786-0131

RIN: 0938-AM93
_______________________________________________________________________




1090. [bull] REVISIONS TO COST SHARING REGULATIONS (CMS-2144-P)

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

Unfunded Mandates: Undetermined

Legal Authority: Social Security Act, sec 1916; Social Security Act, 
sec 1902(a)(4)

CFR Citation: 42 CFR 447.51 to 447.56

Legal Deadline: None

Abstract: This proposed rule would revise the cost sharing requirements 
in our current regulation to allow for the imposition of higher levels 
of cost sharing and more flexibility in the way in which cost sharing 
is imposed and administered under current statutory requirements. (The 
cost sharing requirements have remained unchanged since 1974. States 
have requested that we update the cost sharing requirements.)

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/00/04

[[Page 72904]]

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Federal, State

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

Agency Contact: Alissa Deboy, Special Assistant, Department of Health 
and Human Services, Centers for Medicare & Medicaid Services, CMSO, S2-
14-26, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-6041

RIN: 0938-AM94
_______________________________________________________________________


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


Centers for Medicare & Medicaid Services (CMS)



_______________________________________________________________________




1091. 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 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                      06/00/04

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses, Organizations

Government Levels Affected: None

Agency Contact: Mercedes Benitex-McCray, Health Insurance Specialist, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, Office of Clinical Standards and Quality, 7500 
Security Boulevard, Baltimore, MD 21244
Phone: 410 786-5716

Scott Cooper, Health Insurance Specialist, Department of Health and 
Human Services, Centers for Medicare & Medicaid Services, Office of 
Clinical Standards and Quality, 7500 Security Boulevard, Baltimore, MD 
21244
Phone: 410 786-9465

RIN: 0938-AG81
_______________________________________________________________________




1092. REQUIREMENTS FOR ESTABLISHING AND MAINTAINING MEDICARE BILLING 
PRIVILEGES (CMS-6002-F)

Priority: Other Significant

Legal Authority: 42 USC 1302; 42 USC 1395hh

CFR Citation: 42 CFR 424

Legal Deadline: None

Abstract: This final 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

________________________________________________________________________

NPRM                            04/25/03                    68 FR 22064
Final Action                    09/00/04

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Michael Collett, Health Insurance Specialist, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, Office of Financial Management, C3-02-06, 7500 
Security Boulevard, Baltimore, MD 21244
Phone: 410 786-6121

RIN: 0938-AH73
_______________________________________________________________________




1093. HEALTH INSURANCE REFORM: STANDARD UNIQUE HEALTH CARE PROVIDER 
IDENTIFIER (CMS-0045-F)

Priority: Other Significant. Major under 5 USC 801.

Legal Authority: 42 USC 1320D-2(b)(1)

CFR Citation: 42 CFR 160; 42 CFR 162

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

Abstract: This final rule establishes a standard unique identifier for 
all health care providers under the Health Insurance Portability and 
Accountability Act (HIPAA) of 1966 (Pub. L. 104-191). The rule 
implements administrative simplification initiatives that have a 
national scope beyond Medicare and Medicaid.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            05/07/98                    63 FR 25320
NPRM Comment Period End         07/06/98
Final Action                    12/00/03

Regulatory Flexibility Analysis Required: Yes

Government Levels Affected: Federal, Local, State, Tribal

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

Additional Information: None

Agency Contact: Patricia Peyton, Office of Information Services, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, N3-20-05, 7500 Security Boulevard, Baltimore, MD 
21224-1850
Phone: 410 786-1812

RIN: 0938-AH99
_______________________________________________________________________




1094. 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

[[Page 72905]]

Abstract: This final rule will extend appeal rights to all suppliers 
whose enrollment applications for Medicare billing privileges are 
disallowed by a carrier or whose Medicare billing privileges are 
revoked, except for those suppliers covered under other existing 
appeals provisions of our regulations. In addition, we will revise 
certain appeal provisions to correspond with the existing appeal 
provisions in those other sections of our regulations. CMS will also 
extend appeal rights to all suppliers not covered by existing 
regulations to ensure they have a full and fair opportunity to be 
heard.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

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

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Ralph Goldberg, Division of Provider and Supplier 
Enrollment, Department of Health and Human Services, Centers for 
Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, MD 
21244
Phone: 410 786-4870

RIN: 0938-AI49
_______________________________________________________________________




1095. COVERAGE OF RELIGIOUS NONMEDICAL 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 403.736; 42 CFR 403. 738; 42 CFR 489.102

Legal Deadline: Final, Statutory, July 1, 1998, Final.

Abstract: This final rule follows an interm final rule with comment 
that removed all references in the Medicare regulations to specific 
religious institutions to broaden Medicare coverage to include all 
religious nonmedical institutions.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              11/30/99                    64 FR 67028
Final Action                    12/00/03

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Jean Marie Moore, Health Insurance Specialist, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, Center for Medicare Management, 7500 Security 
Boulevard, C5-05-05, Baltimore, MD 21244
Phone: 410 786-3508

RIN: 0938-AI93
_______________________________________________________________________




1096. MEDICARE OUTCOME AND ASSESSMENT INFORMATION SET (OASIS) DATA 
REPORTING REQUIREMENTS (CMS-3006-F)

Priority: Other Significant. Major under 5 USC 801.

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

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

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

Legal Deadline: 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
Final Rule                      06/00/04

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: Aucha Prachanronarong, Health Insurance Specialist, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, Office of Clinical Standards and Quality, 7500 
Security Blvd, Baltimore, MD 21244
Phone: 410 786-9614

RIN: 0938-AJ10
_______________________________________________________________________




1097. 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(BBA 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 assessment and performance improvement program. (The statute 
required that this rule be published by January 1, 1999.)

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            02/28/00                    65 FR 10450
Final Rule                      12/00/03

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: Federal

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

RIN: 0938-AJ17

[[Page 72906]]

_______________________________________________________________________




1098. HOSPITAL CONDITIONS OF PARTICIPATION: LABORATORY SERVICES (CMS-
3014-F)

Priority: Substantive, Nonsignificant

Legal Authority: 42 USC 1302; 42 USC 1395hh

CFR Citation: 42 CFR 482.27

Legal Deadline: None

Abstract: This rule requires hospitals that transfuse blood and blood 
products to prepare and follow written procedures for appropriate 
action when it is determined that blood and blood products the hospital 
received and transfused are at increased risk for transmitting HCV; 
quarantine prior collections from a donor who is at increased risk for 
transmitting HCF infection; notify transfusion recipients, as 
appropriate, of the need for HCV testing and counseling; and maintain 
records for at least 10 years.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            11/16/00                    65 FR 69416
Final Rule                      08/00/04

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Mary Collins, Health Insurance Specialist, Department 
of Health and Human Services, Centers for Medicare & Medicaid Services, 
Office of Clinical Standards and Quality, 7500 Security Boulevard, S3-
02-01, Baltimore, MD 21244
Phone: 410 786-3189

RIN: 0938-AJ29
_______________________________________________________________________




1099. MEDICARE HOSPICE CARE AMENDMENTS (CMS-1022-F)

Priority: Substantive, Nonsignificant

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

CFR Citation: 42 CFR 418

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            11/22/02                    67 FR 70363
Final Action                    09/00/04

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Thomas Saltz, Health Insurance Specialist, Department 
of Health and Human Services, Centers for Medicare & Medicaid Services, 
Centers for Medicare Management, 7500 Security Boulevard, C4-05-27, 
Baltimore, MD 21244
Phone: 410 786-4480

RIN: 0938-AJ36
_______________________________________________________________________




1100. USE OF RESTRAINT AND SECLUSION IN RESIDENTIAL TREATMENT FACILITIES 
PROVIDING INPATIENT PSYCHIATRIC SERVICES TO INDIVIDUALS UNDER AGE 21 
(CMS-2065-F)

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

RIN: 0938-AJ96
_______________________________________________________________________




1101. ALL PROVIDER BAD DEBT PAYMENT (CMS-1126-F)

Priority: Other Significant. Major under 5 USC 801.

Legal Authority: 42 USC 1302; 42 USC 1395f(b); 42 USC 1395g; 42 USC 
1395l(a); 42 USC 1395l(i); 42 USC 1395l(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 final rule will achieve a consistent bad debt 
reimbursement policy for all providers currently eligible to receive 
payments from Medicare for bad debt. It implements a court settlement 
agreement and removes the cap on End Stage Renal Disease (ESRD) bad 
debt reimbursement, which limits payment of allowable bad debts to the 
facility's unrecovered costs.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            02/10/03                     68 FR 6682
NPRM Comment Period End         04/11/03
Final Action                    12/00/03

Regulatory Flexibility Analysis Required: Yes

Government Levels Affected: None

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

RIN: 0938-AK02
_______________________________________________________________________




1102. REVIEW OF NATIONAL COVERAGE DETERMINATIONS AND LOCAL COVERAGE 
DETERMINATIONS (CMS-3063-F)

Priority: Other Significant

Legal Authority: Sec 522 of the BIPA 2000

CFR Citation: 42 CFR 405

Legal Deadline: NPRM, Statutory, October 1, 2001, NPRM.

Abstract: This final rule would announce a new process for 
beneficiaries to appeal national and local coverage determinations 
(LCDs), including the role that the Department Appeals Board and, in 
the case of LCDs, Administrative Law Judges, will have in reviewing the 
decisions. It implements section 522 of the Benefits Improvement and 
Protection Act of 2000 (BIPA).

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            08/22/02                    67 FR 54534
NPRM Comment Period End         10/21/02
Final Action                    12/00/03

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: James Bossenmeyer, Health Insurance Specialist, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, C5-16-26, 7500 Security Boulevard, Baltimore, MD 
21244
Phone: 410 786-9317

[[Page 72907]]

Email: [email protected]

RIN: 0938-AK60
_______________________________________________________________________




1103. PHYSICIANS' REFERRALS TO HEALTH CARE ENTITIES WITH WHICH THEY HAVE 
FINANCIAL RELATIONSHIPS--PHASE II (CMS-1810-FC)

Priority: Other Significant

Legal Authority: 42 USC 1877

CFR Citation: 42 CFR 411

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Action                    12/00/03

Regulatory Flexibility Analysis Required: Yes

Government Levels Affected: None

Agency Contact: Joanne Sinsheimer, Technical Advisor, CMM, Department 
of Health and Human Services, Centers for Medicare & Medicaid Services, 
Center for Medicaid and State Operations, 7500 Security Boulevard, C4-
25-02, Baltimore, MD 21244
Phone: 410 786-4620

RIN: 0938-AK67
_______________________________________________________________________




1104. RATE OF REIMBURSEMENT OF PHOTOCOPY EXPENSES FOR QUALITY 
IMPROVEMENT ORGANIZATIONS (CMS-3055-F)

Priority: Substantive, Nonsignificant

Legal Authority: Social Security Act, sec 1102; Social Security Act, 
sec 1154; Social Security Act, sec 1159; Social Security Act, sec 1866; 
Social Security Act, sec 1871

CFR Citation: 42 CFR 476.78

Legal Deadline: None

Abstract: This rule increases the rate of reimbursement of photocopy 
expenses as required by the regulations governing utilization and 
quality control quality improvement organizations. CMS' current 
regulations identify the photocopying reimbursement methodology for 
prospective payment system hospitals.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            11/22/02                    67 FR 70358
Final Action                    12/00/03

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: Undetermined

Agency Contact: Les Caplan, Health Insurance Specialist, Department of 
Health and Human Services, Centers for Medicare & Medicaid Services, 
Office of Clinical Standards and Quality, 7500 Security Boulevard, 
Baltimore, MD 21244
Phone: 410 786-7223

RIN: 0938-AK68
_______________________________________________________________________




1105. ELIMINATION OF STATEMENT OF INTENT PROCEDURES FOR FILING MEDICARE 
CLAIMS (CMS-1185-F)

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: The final rule would eliminate the written statement of 
intent procedures for filing Medicare claims from the current Medicare 
regulation. Providers, suppliers, and other qualified claimants would 
still have 15 to 27 months to submit valid claims to Medicare.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            07/25/03                    68 FR 44000
Final Action                    07/00/04

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: Federal, State

Agency Contact: David Walczak, Health Insurance Specialist, Department 
of Health and Human Services, Centers for Medicare & Medicaid Services, 
Center for Health Plans and Providers, Plan and Provider Purchasing 
Policy Group, 7500 Security Boulevard, C4-25-02, Baltimore, MD 21244
Phone: 410 786-4475

RIN: 0938-AK79
_______________________________________________________________________




1106. EXTENDING MEDICARE ENTITLEMENT WHEN DISABILITY BENEFIT ENTITLEMENT 
ENDS BECAUSE OF SUBSTANTIAL GAINFUL ACTIVITY (CMS-4018-F)

Priority: Substantive, Nonsignificant

Legal Authority: Sec 202 of the TWWIIA of 1999; PL 106-170

CFR Citation: 42 CFR 406.12

Legal Deadline: None

Abstract: This final rule implements the Ticket to Work and Work 
Incentives Improvement Act of 1999. It provides working disabled 
individuals with continued Medicare entitlement for an additional 54 
months beyond the current limit, for a total of 78 months of Medicare 
coverage following the 15th month of the extended period of 
eligibility.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            07/25/03                    68 FR 43998
Final Action                    07/00/04

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Denise Cox, Department of Health and Human Services, 
Centers for Medicare & Medicaid Services, Health Insurance Specialist, 
7500 Security Boulevard, S1-05-06, Baltimore, MD 21244
Phone: 410 786-3195

RIN: 0938-AK94
_______________________________________________________________________




1107. MEDICARE PROGRAM; INTEREST CALCULATION (CMS-6014-F)

Priority: Other Significant

Legal Authority: Sec 1815(d) of the Social Security Act; Sec 1833 (j) 
of the Social Security Act

CFR Citation: 42 CFR 405.378

Legal Deadline: None

Abstract: This final rule will change the formula for computing 
interest on provider and supplier overpayments

[[Page 72908]]

and underpayments to make it consistent with the new CMS accounting 
system, Healthcare Integrated General Ledger Accounting System.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            07/25/03                    68 FR 43995
Final Action                    07/00/04

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses, Organizations

Government Levels Affected: None

Agency Contact: Nancy Braymer, Financial Management Specialist, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, C3-14-21, 7500 Security Boulevard, Baltimore, MD 
21244
Phone: 410 786-4323

RIN: 0938-AL14
_______________________________________________________________________




1108. 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 146.111; 45 CFR 146.113; 45 CFR 
146.115; 45 CFR 146.117; 45 CFR 146.119; 45 CFR 146.120; 45 CFR 
146.125; 45 CFR 146.143; . . .

Legal Deadline: None

Abstract: This final rule provides portability requirements for group 
health plans and issuers of health insurance coverage offered in 
connection with a group health plan under the Health Insurance 
Portability and Accountability Act of 1996. This regulation addresses 
limitations or preexisting exclusion periods on 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                    05/00/04

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: Federal, Local, State

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

RIN: 0938-AL43
_______________________________________________________________________




1109. PERMITTING PREMIUM REDUCTIONS AS ADDITIONAL BENEFITS UNDER 
MEDICARE+CHOICE PLANS (CMS-6016-F)

Priority: Substantive, Nonsignificant

Legal Authority: 606 of BIPA

CFR Citation: 42 CFR 408

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

Abstract: This final rule implements section 606 of the Benefits 
Improvement and Protection Act of 2000 to allow Medicare+Choice 
organizations to elect a reduction in capitation payments so that these 
organizations could offer Medicare part B premium reductions to 
enrollees.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Action                    12/00/03

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: Federal, Local, State

Agency Contact: Michele Sanders, Department of Health and Human 
Services, Centers for Medicare & Medicaid Services, Office of Financing 
Management, 7500 Security Boulevard, S1-06-27, Baltimore, MD 21244
Phone: 410 786-0808

RIN: 0938-AL49
_______________________________________________________________________




1110. REVISIONS TO THE MEDICARE APPEALS PROCESS (CMS-4004-FC)

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

RIN: 0938-AL67
_______________________________________________________________________




1111. CHANGES TO THE HOSPITAL OUTPATIENT PROSPECTIVE PAYMENT SYSTEM AND 
CALENDAR YEAR 2004 PAYMENT RATES (CMS-1471-F)

Priority: Other Significant. Major under 5 USC 801.

Legal Authority: 42 USC 1395L; Balanced Budget Act of 1997; Medicare, 
Medicaid, and SCHIP; Balanced Budget Refinement Act of 1999; Medicare, 
Medicaid, and SCHIP; Benefits Improvement and Protection Act of 2000

CFR Citation: Not Yet Determined

Legal Deadline: None

Abstract: This final rule adjusts payments under the Medicare hospital 
outpatient payment system beginning January 1, 2004.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            08/12/03                    68 FR 47966
Final Action                    12/00/03

Regulatory Flexibility Analysis Required: Yes

Government Levels Affected: Federal

Agency Contact: Cindy Read, Division Director, Department of Health and 
Human Services, Centers for Medicare & Medicaid Services, Center for 
Medicare Management, C4-05-07, 7500 Security Boulevard, Baltimore, MD 
21244
Phone: 410 786-1852

RIN: 0938-AL91
_______________________________________________________________________




1112. ELECTRONIC MEDICARE CLAIMS SUBMISSION (CMS-0008-F)

Priority: Other Significant

Legal Authority: PL 107-105

CFR Citation: Not Yet Determined

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              08/15/03                    68 FR 48805

[[Page 72909]]

Interim Final Rule Comment 
Period End                      10/16/03
Final Rule                      09/00/04

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: None

Agency Contact: Stewart Streimer, Director, Division of Operations 
Standards, Office of Program Administration, Department of Health and 
Human Services, Centers for Medicare & Medicaid Services, 1-C-6 Meadows 
East Building, 6325 Security Boulevard, Baltimore, MD 21207
Phone: 410 786-9318

RIN: 0938-AM22
_______________________________________________________________________




1113. INPATIENT HOSPITAL DEDUCTIBLE AND HOSPITAL AND EXTENDED CARE 
SERVICES COINSURANCE AMOUNTS FOR CALENDAR YEAR 2004 (CMS-8016-N)

Priority: Other Significant

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

CFR Citation: None

Legal Deadline: NPRM, Statutory, September 15, 2003, NPRM.

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                          12/00/03

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

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

RIN: 0938-AM31
_______________________________________________________________________




1114. MONTHLY ACTUARIAL RATES AND MONTHLY SUPPLEMENTARY MEDICAL 
INSURANCE PREMIUM RATE BEGINNING JANUARY 1, 2004 (CMS-8017-N)

Priority: Other Significant

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

CFR Citation: None

Legal Deadline: NPRM, Statutory, September 30, 2003, NPRM.

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Notice                          12/00/03

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Carter S. Warfield, Deputy Director, Medicare and 
Medicaid Cost Estimates Group, OACT, Department of Health and Human 
Services, Centers for Medicare & Medicaid Services, Center of Medicaid 
and State Operations, 7500 Security Boulevard, N3-26-00, Baltimore, MD 
21244
Phone: 410 786-6396

RIN: 0938-AM32
_______________________________________________________________________




1115. PART A PREMIUMS FOR CALENDAR YEAR 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); Sec 
1818(d)(2) of the Social Security Act; Sec 1818A(d)(2) of the Social 
Security Act

CFR Citation: None

Legal Deadline: NPRM, Statutory, September 30, 2003, NPRM.

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                          12/00/03

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

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

RIN: 0938-AM33
_______________________________________________________________________




1116. GRANTS TO STATES FOR OPERATION OF QUALIFIED HIGH RISK POOLS (CMS-
2179-F)

Priority: Other Significant

Legal Authority: PL 107-210

CFR Citation: 45 CFR 148

Legal Deadline: None

Abstract: This final rule announces a grant program to provide $40 
million for FY 2003 and $40 million for FY 2004 to Sates that have 
qualified high risk pools under the Trade Adjustment Assistance Reform 
Act of 2002.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Rule with Comment         05/02/03                    68 FR 23410
Final Rule Comment Period End   07/01/03
Final Rule Effective            06/02/03
Final Action                    03/00/04

Regulatory Flexibility Analysis Required: No

Government Levels Affected: State

Agency Contact: James Mayhew, Health Insurance Specialist, Department 
of Health and Human Services, Centers for Medicare & Medicaid Services, 
Center for Medicaid and State Operations, 7500 Security Boulevard, S3-
16-26, Baltimore, MD 21244
Phone: 410 786-9244

RIN: 0938-AM42

[[Page 72910]]

_______________________________________________________________________




1117. FEE SCHEDULE FOR PAYMENT OF AMBULANCE SERVICES UPDATE FOR CALENDAR 
YEAR 2004 (CMS-1232-FC)

Priority: Other Significant

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

CFR Citation: None

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Rule                      12/00/03

Regulatory Flexibility Analysis Required: Yes

Government Levels Affected: None

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

RIN: 0938-AM44
_______________________________________________________________________




1118. [bull] NON--FEDERAL GOVERNMENTAL PLANS EXEMPT FROM HIPAA TITLE I 
REQUIREMENTS (CMS-2033-F)

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

Legal Authority: Sec 2721(b)(2) of the Public Health Service Act

CFR Citation: 45 CFR 146.180

Legal Deadline: None

Abstract: This final rule adopts as final the exemption election 
requirements that apply to self-funded non-Federal governmental plans. 
Since we received no public comments on the July 26, 2002, interim 
final with comment period, this rule finalizes the circumstances under 
which plan sponsors may exempt these plans from most of the 
requirements of title XXVII of the Public Health Service Act and 
provides guidance on the procedures, limitations, and documentation 
associated with exemption elections.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Action                    05/00/04

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: Local, State

Agency Contact: Dave Holstein, Health Insurance Specialist, Department 
of Health and Human Services, Centers for Medicare & Medicaid Services, 
Insurance Standards Team, S3-16-16, 7500 Security Boulevard, Baltimore, 
MD 21244
Phone: 410 786-1564

RIN: 0938-AM71
_______________________________________________________________________




1119. [bull] REVISIONS TO THE APPEALS PROCESS FOR INITIAL CLAIM 
DETERMINATIONS (CMS-4064-F)

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

RIN: 0938-AM73
_______________________________________________________________________




1120. [bull] MORE FLEXIBLE REQUIREMENTS FOR POWERED-OPERATED VEHICLES 
(CMS-3017-FC)

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

Legal Authority: Sec 1102 of the Social Security Act; Sec 1871 of the 
Social Security Act

CFR Citation: 42 CFR ch IV, sec 410, subpart B; 42 CFR 410.38

Legal Deadline: None

Abstract: This rule will make the requirements to purchase power 
operated vehicles, functioning as wheelchairs, less stringent.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Action with Comment       02/00/04

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Lorrie Ballantine, Health Insurance Specialist, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, S3-02-01, 7500 Security Boulevard, Baltimore, MD 
21244
Phone: 410 786-7543

RIN: 0938-AM74
_______________________________________________________________________




1121. [bull] HOSPICE WAGE INDEX FY 2005 (CMS-1264-N)

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

Legal Authority: 1814(i)(A)

CFR Citation: 42 CFR 418.306(d)

Legal Deadline: Final, Statutory, October 1, 2004, Final.
Wage Index update is effective October 1, of each year.

Abstract: This notice will announce the annual update to the hospice 
wage index for FY 2005. The wage index is used to reflect local 
differences in wage levels. The hospice wage index methodology and 
values are based on recommendations of a negotiated rulemaking advisory 
committee and were originally published on August 8, 1997.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Notice                          08/00/04

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Terri Deutseh, Health Insurance Specialist, Department 
of Health and Human Services, Centers for Medicare & Medicaid Services, 
C5-08-28, 7500 Security Blvd, Baltimore, MD 21244
Phone: 410 786-9462

RIN: 0938-AM78
_______________________________________________________________________




1122. [bull] TICKET TO WORK: DEFINING INDIVIDUALS WITH POTENTIALLY 
SEVERE DISABILITIES (CMS-2172-N)

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

Legal Authority: Ticket to Work and Work Incentives Improvement Act of 
1999

CFR Citation: None

Legal Deadline: None

Abstract: This proposed rule would provide a definition of ``medically 
determinable severe impairment'' under the Ticket to Work and Work 
Incentives Improvement Act of 1999.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Notice                          08/00/04

Regulatory Flexibility Analysis Required: No

[[Page 72911]]

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Carey O'Connor, Health Insurance Specialist, Department 
of Health and Human Services, Centers for Medicare & Medicaid Services, 
Center for Medicaid and State Operations, 7500 Security Boulevard, S2-
14-26, Baltimore, MD 21224
Phone: 410 786-2117

RIN: 0938-AM79
_______________________________________________________________________




1123. [bull] HOSPITAL CONDITIONS OF PARTICIPATION: REQUIREMENTS FOR 
HISTORY AND PHYSICAL EXAMINATIONS; AUTHENTICATION OF VERBAL ORDERS, 
SECURING MEDICATIONS AND POST-ANESTHESIA EVALUATIONS (CMS-3122-F)

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

Legal Authority: 42 USC 1395 x; 42 USC 1396 d; 42 USC 1395 bb

CFR Citation: 42 CFR 482

Legal Deadline: None

Abstract: This final rule will change the existing requirements to 
decrease the burden on hospitals to conform to current standards of 
practice. Hospitals must meet these final requirements to participate 
in the Medicare and Medicaid programs. They must establish and maintain 
policies and procedures that will ensure their hospital will meet these 
requirements by using standard practices with regards to history and 
physical examinations, and completion of the post-anesthesia 
evaluation.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Action                    03/00/04

Regulatory Flexibility Analysis Required: Yes

Government Levels Affected: None

Agency Contact: Patricia Chmielewski, Health Insurance Specialist, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-6899

RIN: 0938-AM88
_______________________________________________________________________




1124. [bull] DISPROPORTIONATE SHARE HOSPITAL (DSH) PAYMENTS INSTITUTIONS 
FOR MENTAL DISEASE (IMDS) (CMS-2062-N)

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

Legal Authority: Not Yet Determined

CFR Citation: None

Legal Deadline: None

Abstract: This notice announces the preliminary Federal share 
disproportionate share hospital (DSH) allotments for Federal fiscal 
year (FFY) 2002 in accordance with the Medicare, Medicaid and SCHIP 
Benefits Improvement and Protection Act of 2000. It also announces the 
FFY 1999, 2000, and 2001 limitations on aggregate DSH payments that 
States may make to institutions for mental disease and other mental 
health facilities. In addition, it specifies a format to be used by 
States when submitting the annual DSH report mandated by the statute

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Notice                          03/00/04

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Jim Frizzera, Health Insurance Specialist, Department 
of Health and Human Services, Centers for Medicare & Medicaid Services, 
CMSO, S3-13-15, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-9535

RIN: 0938-AM89
_______________________________________________________________________


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


Centers for Medicare & Medicaid Services (CMS)



_______________________________________________________________________




1125. STANDARD UNIQUE NATIONAL HEALTH PLAN IDENTIFIERS (CMS-6017-P)

Priority: Substantive, Nonsignificant. Major under 5 USC 801.

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

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

CFR Citation: 45 CFR 160; 45 CFR 162

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

Abstract: This proposed rule would implement a standard identifier to 
identify health plans that process and pay certain electronic health 
care transactions. It would implement one of the requirements for 
administrative simplification in section 262 of the Health Insurance 
Portability & Accountability Act of 1996.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                             To Be                       Determined

Regulatory Flexibility Analysis Required: Yes

Government Levels Affected: State

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

Agency Contact: Helen Dietrick, Department of Health and Human 
Services, Centers for Medicare & Medicaid Services, S1-07-17, Office of 
Information Services, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-7448

RIN: 0938-AH87
_______________________________________________________________________




1126. EXCLUSION OF MEDICARE BENEFITS FOR ALIENS NOT LAWFULLY PRESENT IN 
THE UNITED STATES (CMS-1222-FC)

Priority: Other Significant

Legal Authority: Sec 5561 of BBA 1997; Sec 401(b) of the Personal 
Responsibility and Work Opportunity Act of 1996; 42 USC 1611(b)

CFR Citation: 42 CFR 411.11

Legal Deadline: None

Abstract: This final rule with comment period amends our regulations to 
prohibit Medicare benefits to an alien who is not lawfully present in 
the United States. Section 5561 of the Balanced Budget Act amended 
section 401(b) of the Personal Responsibility and Work Opportunity Act 
of 1996 to prohibit Medicare payments for services furnished to an 
alien who is

[[Page 72912]]

not ``lawfully present in the United States'' and meets certain other 
conditions.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule               To Be                       Determined

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Frederick William Grabau, Health Insurance Specialist, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, Center of Medicaid and State Operations, 7500 
Security Boulevard, C4-25-02, Baltimore, MD 21244
Phone: 410 786-0206

RIN: 0938-AM47
_______________________________________________________________________




1127. [bull] CHANGES TO THE CRITERIA FOR BEING CLASSIFIED AS AN 
INPATIENT REHABILITATION FACILITY (CMS-1262-F)

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

Legal Authority: Sec 1886 of the Social Security Act; 42 USC 1395cc

CFR Citation: 42 CFR 412

Legal Deadline: None

Abstract: This final rule would revise classification criteria, 
commonly known as the ``75 percent rule,'' for a hospital to be 
classified as an inpatient rehabilitation facility (IRF). It would also 
modify and expand the medical conditions listed in the 75 percent rule 
regulatory requirements. We are proposing these changes to ensure that 
patients in IRF settings receive appropriate intensive inpatient 
rehabilitation services.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/09/03                    68 FR 53266
Final Rule                      10/00/04

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Undetermined

Government Levels Affected: None

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

RIN: 0938-AM72
_______________________________________________________________________


Department of Health and Human Services (HHS)         Completed Actions


Centers for Medicare & Medicaid Services (CMS)



_______________________________________________________________________




1128. CONDITIONS OF PARTICIPATION OF INTERMEDIATE CARE FACILITIES FOR 
PERSONS WITH MENTAL RETARDATION (CMS-3046-P)

Priority: Other Significant

CFR Citation: 42 CFR 400; 42 CFR 435; 42 CFR 440; 42 CFR 441; 42 CFR 
483

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn                       08/19/03

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Anita Panicker
Phone: 410 786-5646

RIN: 0938-AK23
_______________________________________________________________________




1129. LABORATORY REQUIREMENTS RELATING TO QUALITY SYSTEMS AND CERTAIN 
PERSONNEL QUALIFICATIONS (CMS-2226-CN)

Priority: Other Significant

CFR Citation: 42 CFR 493

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Correction Notice               08/22/03                    68 FR 50722

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Cecelia Hinkel
Phone: 410 786-3347

RIN: 0938-AK24
_______________________________________________________________________




1130. FIRE SAFETY REQUIREMENTS FOR CERTAIN HEALTH CARE FACILITIES (CMS-
3047-F)

Priority: Other Significant

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

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    01/10/03                     68 FR 1374

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Danielle Shearer
Phone: 410 786-6617

RIN: 0938-AK35
_______________________________________________________________________




1131. HOSPITAL CONDITIONS OF PARTICIPATION: QUALITY ASSESSMENT AND 
PERFORMANCE IMPROVEMENTS (QAPI) (CMS-3050-F)

Priority: Other Significant

CFR Citation: 42 CFR 482.21

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Rule                      01/24/03                     68 FR 3435

Regulatory Flexibility Analysis Required: Yes

Government Levels Affected: State

Agency Contact: Nancy Archer
Phone: 410 786-0596

RIN: 0938-AK40
_______________________________________________________________________




1132. REVISED PROCESS FOR MAKING MEDICARE NATIONAL COVERAGE 
DETERMINATIONS (CMS-3062-N)

Priority: Other Significant

CFR Citation: None

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Notice                          09/26/03                      68 FR 187

Regulatory Flexibility Analysis Required: No

Government Levels Affected: Federal

Agency Contact: Vadim Lubarsky
Phone: 410 786-0840

RIN: 0938-AK61

[[Page 72913]]

_______________________________________________________________________




1133. MODIFICATIONS TO MEDICARE MANAGED CARE RULES (CMS-4041-F)

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

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

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Rule                      08/22/03                    68 FR 50839

Regulatory Flexibility Analysis Required: Yes

Government Levels Affected: Federal

Agency Contact: Tony Hausner
Phone: 410 786-1093

RIN: 0938-AK71
_______________________________________________________________________




1134. INPATIENT DISPROPORTIONATE SHARE HOSPITAL (DSH) ADJUSTMENT: 
CALCULATION OF MEDICAID PATIENT AND TOTAL PATIENT DAYS IN THE MEDICARE 
DSH ADJUSTMENT (CMS-1171-P)

Priority: Other Significant

CFR Citation: 42 CFR 412106

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Merged With 0938-AL89           08/08/03

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Stephen Phillips
Phone: 410 786-4548

RIN: 0938-AK77
_______________________________________________________________________




1135. MODIFICATIONS TO THE STATE CHILDREN'S HEALTH INSURANCE PROGRAM 
(SCHIP) (CMS-2006-F)

Priority: Substantive, Nonsignificant

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

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn                       11/18/03

Regulatory Flexibility Analysis Required: No

Government Levels Affected: State

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

Agency Contact: Cheryl Austein-Casnoff
Phone: 410 786-4196

RIN: 0938-AL00
_______________________________________________________________________




1136. REQUIREMENTS FOR PAID FEEDING ASSISTANTS IN long-term CARE 
FACILITIES (CMS-2131-F)

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

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

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Rule                      09/26/03                    68 FR 55528

Regulatory Flexibility Analysis Required: No

Government Levels Affected: Federal, State

Agency Contact: Nola Petrovich
Phone: 410 786-4671

RIN: 0938-AL18
_______________________________________________________________________




1137. CHANGES TO THE HOSPITAL OUTPATIENT PROSPECTIVE PAYMENT SYSTEM AND 
CALENDAR YEAR 2003 PAYMENT RATES; CHANGES TO PAYMENT SUSPENSION FOR 
UNFILED COST REPORTS; CORRECTION TO FINAL RULE (CMS-1206-CN2)

Priority: Other Significant. Major under 5 USC 801.

CFR Citation: 42 CFR 405; 42 CFR 419

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Correction Notice               10/01/03                    67 FR 69146
Correction Notice               02/10/03                     68 FR 6636

Regulatory Flexibility Analysis Required: Yes

Government Levels Affected: Federal

Agency Contact: Cindy Read
Phone: 410 786-1852

RIN: 0938-AL19
_______________________________________________________________________




1138. PAYMENT FOR RESPIRATORY ASSIST DEVICES WITH BI-LEVEL CAPABILITY 
AND A BACK-UP RATE (CMS-1167-F)

Priority: Other Significant

CFR Citation: 42 CFR 414

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

NPRM                            08/22/03                   68 FR 50 735
Withdrawn                       10/10/03

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Joel Kaiser
Phone: 410 786-4499

RIN: 0938-AL27
_______________________________________________________________________




1139. INTERIM FINAL AMENDMENT FOR MENTAL HEALTH PARITY (CMS-2152-IFC)

Priority: Substantive, Nonsignificant

CFR Citation: 45 CFR 146.136

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Second Interim Final Rule       06/27/03                    68 FR 38206
Second Interim Final Rule 
Effective                       07/28/03

Regulatory Flexibility Analysis Required: No

Government Levels Affected: Local, State

Agency Contact: David Mlawsky
Phone: 410 786-6851

RIN: 0938-AL44
_______________________________________________________________________




1140. ELECTRONIC SUBMISSION OF COST REPORTS (CMS-1199-F)

Priority: Substantive, Nonsignificant

CFR Citation: 42 CFR 413.24

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    08/22/03                    68 FR 50717

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Carol Blackford
Phone: 410 786-5909

RIN: 0938-AL51
_______________________________________________________________________




1141. EXCLUSIONS FROM THE DEFINITION OF ``OPTIONAL TARGETED LOW-INCOME 
CHILD'' AND PURCHASE OF FAMILY COVERAGE--BENEFIT FLEXIBILITY IN PARENT 
COVERAGE (CMS-2148-P)

Priority: Substantive, Nonsignificant

CFR Citation: 42 CFR 457

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn                       11/18/03

Regulatory Flexibility Analysis Required: No

[[Page 72914]]

Government Levels Affected: None

Agency Contact: Stacey Bush
Phone: 410 786-6102

RIN: 0938-AL62
_______________________________________________________________________




1142. STATE ALLOTMENTS FOR PAYMENT OF MEDICARE PART B PREMIUMS FOR 
QUALIFYING INDIVIDUALS; FEDERAL FY 2002 (CMS-2136-FN)

Priority: Other Significant. Major under 5 USC 801.

CFR Citation: None

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    08/22/03                    68 FR 50790

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Robert Nakielny
Phone: 410 786-4466

RIN: 0938-AL79
_______________________________________________________________________




1143. MEDICAID COVERAGE RULES FOR INMATES OF PUBLIC INSTITUTIONS (CMS-
2077-P)

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

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

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn                       08/08/03

Regulatory Flexibility Analysis Required: No

Government Levels Affected: Local, State

Agency Contact: Tom Shenk
Phone: 410 786-3295

RIN: 0938-AL85
_______________________________________________________________________




1144. TARGETED CASE MANAGEMENT (CMS-2061-P)

Priority: Substantive, Nonsignificant

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

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn                       08/08/03

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Kathy Poisal
Phone: 410 786-5940

RIN: 0938-AL87
_______________________________________________________________________




1145. CHANGES TO THE HOSPITAL INPATIENT PROSPECTIVE PAYMENT SYSTEM AND 
FY 2004 RATES (CMS-1470-F)

Priority: Economically Significant. Major under 5 USC 801.

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

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

NPRM                            05/19/03                    68 FR 27154
Final Action                    08/01/03                    68 FR 45346

Regulatory Flexibility Analysis Required: Yes

Government Levels Affected: None

Agency Contact: Tzvi Hefter
Phone: 410 786-4487

Scott Cooper
Phone: 410 786-9465

RIN: 0938-AL89
_______________________________________________________________________




1146. PROSPECTIVE PAYMENT SYSTEM AND CONSOLIDATED BILLING FOR SKILLED 
NURSING FACILITIES--UPDATE FOR FY 2004 (CMS-1469-F)

Priority: Other Significant. Major under 5 USC 801.

CFR Citation: 42 CFR 413.330 to 413.350

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

NPRM                            05/16/03                    68 FR 26758
Final Rule                      08/04/03                    68 FR 46036

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: William Ullman
Phone: 401 786-5667

RIN: 0938-AL90
_______________________________________________________________________




1147. PROSPECTIVE PAYMENT SYSTEM FOR long-term CARE HOSPITALS FOR FY 
2004 (CMS-1472-P)

Priority: Substantive, Nonsignificant

CFR Citation: 42 CFR 412; 42 CFR 413

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    06/06/03                    68 FR 34122

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Tzvi Hefter
Phone: 410 786-4487

RIN: 0938-AL92
_______________________________________________________________________




1148. HOME HEALTH PROSPECTIVE PAYMENT SYSTEM RATE UPDATE FOR FY 2004 
(CMS-1473-NC)

Priority: Other Significant

CFR Citation: None

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Notice                          07/02/03                    68 FR 39763

Regulatory Flexibility Analysis Required: Yes

Government Levels Affected: None

Agency Contact: Randy Throndset
Phone: 410 786-0131

RIN: 0938-AL94
_______________________________________________________________________




1149. PROSPECTIVE PAYMENT SYSTEM FOR INPATIENT REHABILITATION HOSPITALS 
FOR FY 2004 (CMS-1474-F)

Priority: Substantive, Nonsignificant

CFR Citation: 42 CFR 412; 42 CFR 413

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

NPRM                            05/16/03                    68 FR 26786
Final Action                    08/01/03                    68 FR 45674

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Robert Kuhl
Phone: 410 786-4597

RIN: 0938-AL95
_______________________________________________________________________




1150. REVISIONS TO PAYMENT POLICIES UNDER THE PHYSICIAN FEE SCHEDULE FOR 
CALENDAR YEAR 2004 (CMS-1476-P)

Priority: Other Significant. Major under 5 USC 801.

CFR Citation: 42 CFR Part 410; 42 CFR Part 414

[[Page 72915]]

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

NPRM                            08/15/03                    68 FR 49029
Final Action                    11/07/03                    68 FR 63196

Regulatory Flexibility Analysis Required: Yes

Government Levels Affected: Federal

Agency Contact: Diane Milstead
Phone: 410 786-3355

RIN: 0938-AL96
_______________________________________________________________________




1151. NONDISCRIMINATION IN POST-HOSPITAL REFERRAL TO HOME HEALTH 
AGENCIES AND OTHER ENTITIES (CMS-1224-F)

Priority: Substantive, Nonsignificant

CFR Citation: 42 CFR 482

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn                       11/18/03

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Elizabeth Carmody
Phone: 410 786-7533

RIN: 0938-AM01
_______________________________________________________________________




1152. UPDATE OF THE LIST OF COVERED PROCEDURES FOR AMBULATORY SURGICAL 
CENTERS (CMS-1885-FC)

Priority: Other Significant

CFR Citation: 42 CFR 416

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Rule                      03/28/03                    68 FR 32406
Final Rule Comment Period End   05/28/03

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Bob Cereghino
Phone: 410 786-4645

RIN: 0938-AM02
_______________________________________________________________________




1153. MEDICAID HOME AND COMMUNITY BASED SERVICES WAIVERS (CMS-2162-P)

Priority: Substantive, Nonsignificant

CFR Citation: 42 CFR 441.300

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn                       10/30/03

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Mary Clarkson
Phone: 410 786-5918

RIN: 0938-AM05
_______________________________________________________________________




1154. PAYMENT REFORM FOR PART B DRUGS (CMS-1229-F)

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

CFR Citation: 42 CFR 405

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Merged With 0938-AL96           08/20/03                    68 FR 50428

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Marjorie Baldo
Phone: 410 786-4617

RIN: 0938-AM12
_______________________________________________________________________




1155. NONDISCRIMINATION IN HEALTH COVERAGE IN THE GROUP MARKET (CMS-
2022-F)

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

CFR Citation: 45 CFR 146.121

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn                       11/18/03

Regulatory Flexibility Analysis Required: No

Government Levels Affected: Local, State

Agency Contact: David Mlawsky
Phone: 410 786-6851

RIN: 0938-AM14
_______________________________________________________________________




1156. BONA FIDE WELLNESS PROGRAMS (CMS-2078-F)

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

CFR Citation: 45 CFR 146.121(f)

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn                       08/27/03

Regulatory Flexibility Analysis Required: Yes

Government Levels Affected: State, Local

Agency Contact: David Mlawsky
Phone: 410 786-6851

RIN: 0938-AM15
_______________________________________________________________________




1157. TIME LIMITATION ON RECALCULATIONS AND DISPUTES UNDER THE DRUG 
REBATE PROGRAM (CMS-2175-FC)

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

CFR Citation: 42 CFR 447.534

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Rule with Comment         08/29/03                    68 FR 51912
Comment Period End              10/28/03

Regulatory Flexibility Analysis Required: Yes

Government Levels Affected: Federal, Local, State

Agency Contact: Marge Lee Watchorn
Phone: 410 786-4361

RIN: 0938-AM20
_______________________________________________________________________




1158. MEDICAID ESTATE RECOVERIES (CMS-2083-P)

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

CFR Citation: None

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn                       08/27/03

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Ingrid Osborne
Phone: 410 786-4461

RIN: 0938-AM30
_______________________________________________________________________




1159. APPLICATION OF THE EMERGENCY MEDICAL TREATMENT AND LABOR ACT 
(EMTALA) (CMS-1063-F)

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

CFR Citation: Not Yet Determined

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Rule                      09/09/03                    68 FR 53222

Regulatory Flexibility Analysis Required: No

[[Page 72916]]

Government Levels Affected: None

Agency Contact: Rebecca Hirshorn
Phone: 410 786-3411

RIN: 0938-AM34
_______________________________________________________________________




1160. PHYSICIAN OWNERSHIP IN SPECIALTY HOSPITALS (CMS-1240-P)

Priority: Substantive, Nonsignificant

CFR Citation: 42 CFR 411

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn                       08/19/03

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Jackie Proctor
Phone: 410 786-8852

RIN: 0938-AM35
_______________________________________________________________________




1161. APPROVAL OF THE JOINT COMMISSION ON ACCREDITATION OF HEALTHCARE 
ORGANIZATIONS (JCAHO) FOR DEEMING AUTHORITY FOR HOSPICES (CMS-2177-FN)

Priority: Routine and Frequent

CFR Citation: None

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    05/30/03                    68 FR 32528

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Cindy Melanson
Phone: 410 786-0310

Cathaleen Ahern
Phone: 410 786-4515

RIN: 0938-AM38
_______________________________________________________________________




1162. HOSPITAL COST-TO-CHARGE RATIOS USED TO CALCULATE COST OUTLIER 
PAYMENTS UNDER THE MEDICARE SHORT-TERM INPATIENT PROSPECTIVE PAYMENT 
SYSTEM (CMS-1243-F)

Priority: Economically Significant. Major under 5 USC 801.

CFR Citation: 42 CFR 412.84; 42 CFR 412.116

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    06/09/03                    68 FR 34494

Regulatory Flexibility Analysis Required: Yes

Government Levels Affected: None

Agency Contact: Stephen Phillips
Phone: 410 786-4548

RIN: 0938-AM41
_______________________________________________________________________




1163. AMBULANCE FEE SCHEDULE CONDITION CODES (CMS-1247-P)

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

CFR Citation: Not Yet Determined

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn                       11/18/03

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Federalism:  Undetermined

Agency Contact: Anne Tayloe
Phone: 410 786-4546

RIN: 0938-AM45
_______________________________________________________________________




1164. HOSPICE WAGE INDEX FOR FY 2004 (CMS-1233-N)

Priority: Routine and Frequent

CFR Citation: 42 CFR 418.306(C)

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Notice                          09/30/03                    68 FR 56478

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Carol Blackford
Phone: 410 786-5909

RIN: 0938-AM56
_______________________________________________________________________




1165. ANNOUNCEMENT OF APPLICATIONS FROM HOSPITALS REQUESTING WAIVERS FOR 
ORGAN PROCUREMENT SERVICE AREAS IN CALENDAR YEAR 2003 (CMS-1246-NC)

Priority: Routine and Frequent

CFR Citation: 42 CFR 486.306

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn                       09/04/03

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Mark Horney
Phone: 410 786-4554

RIN: 0938-AM59
_______________________________________________________________________




1166. [bull] CENTERS FOR MEDICARE AND MEDICAID SERVICES ACTION ON 
LIABILITY INSURANCE REGULATIONS (CMS-1475-FC)

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

Legal Authority: Sec 1862(b)(2)(A) of the Social Security Act; 42 USC 
1395y

CFR Citation: 42 CFR 411.54(C)(2)(i)

Legal Deadline: None

Abstract: The court ruled that our 1991 regulation is inconsistent with 
the statutory provision, which prohibits Medicare from making payment 
when other insurance is available and permits a provider or supplier 
(including a physician) to seek payment from a liability or a 
beneficiary's liability settlement. CMS has not removed the 
unenforceable regulation.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Rule with Comment         07/25/03                    68 FR 43940
Final Rule Effective            08/25/03
Final Rule Comment Period End   09/23/03

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Suzanne Ripley, Health Insurance Specialist, Department 
of Health and Human Services, Centers for Medicare & Medicaid Services, 
C4-25-02, 7500 Security Blvd, Baltimore, MD 21244
Phone: 410 786-0970

RIN: 0938-AM64

[[Page 72917]]

_______________________________________________________________________


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


Administration for Children and Families (ACF)



_______________________________________________________________________




1167. SAFEGUARDING CHILD SUPPORT AND EXPANDED FEDERAL PARENT LOCATOR 
SERVICES (FPLS) INFORMATION

Priority: Substantive, Nonsignificant

Legal Authority: 42 USC 652 to 654A; 42 USC 663; 42 USC 1302

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

Legal Deadline: None

Abstract: The Personal Responsibility and Work Opportunity 
Reconciliation Act of 1996 made far-reaching amendments to title IV--D 
of the Social Security Act, which governs the child support enforcement 
program. The Balanced Budget Act of 1997, the Adoption and Safe 
Families Act of 1997, and the Child Support Performance and Incentive 
Act of 1998 further amended title IV-D. A significant result of this 
legislation is an expansion in the scope of information available to 
State IV-D child support enforcement agencies. The legislation has 
rendered obsolete or inconsistent several regulations at 45 CFR chapter 
III, Office of Child Support Enforcement, including the regulations on 
the Federal Parent Locator Service, the State Parent Locator Services, 
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                            03/00/04

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
_______________________________________________________________________




1168. 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, Final.

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                            03/00/04

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
_______________________________________________________________________




1169. ADMINISTRATIVE COSTS FOR CHILDREN IN TITLE IV-E FOSTER CARE

Priority: Substantive, Nonsignificant

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

CFR Citation: 45 CFR 1356.60(c)

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            02/00/04

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: State

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

RIN: 0970-AC14
_______________________________________________________________________




1170. [bull] ADMINISTRATIVE COST SHARING UNDER TANF

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

Legal Authority: 42 USC 1302

CFR Citation: 45 CFR 263; 45 CFR 263.14

Legal Deadline: None

Abstract: This proposed rule will enable States (including the District 
of Columbia) and territories to use either the ``primary program'' cost 
allocation methodology previously allowed under the Aid to Families 
with Dependent Children (AFDC) program to allocate the common 
administrative costs of determining eligibility in the Temporary 
Assistance for Needy Families (TANF) program, the Medicaid program, and 
the Food Stamp programs or to continue to use a ``benefiting'' cost 
allocation methodology. Pursuant to a determination by Secretary 
Thompson, States and territories would be able to elect to use their 
Federal TANF funds to pay for costs that are common to the 
administration of the TANF, Medicaid, and Food Stamps Programs, in 
accordance with the primary program cost allocation methodology 
previously allowed under the former AFDC program.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            03/00/04

[[Page 72918]]

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: Local, State

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

Agency Contact: April Kaplan, Deputy Director, Office of Family 
Assistance, Department of Health and Human Services, Administration for 
Children and Families, 5th Floor East, 370 L'Enfant Promenade SW., 
Washington, DC 20447
Phone: 202 401-5138
Email: [email protected]

RIN: 0970-AC15
_______________________________________________________________________


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


Administration for Children and Families (ACF)



_______________________________________________________________________




1171. 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 Rule                      12/00/03

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
_______________________________________________________________________




1172. CHILD SUPPORT ENFORCEMENT PROGRAM; FEDERAL TAX REFUND OFFSET

Priority: Substantive, Nonsignificant

Legal Authority: 42 USC 664; 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              06/26/03                    68 FR 37978
Final Action                    06/00/04

Regulatory Flexibility Analysis Required: No

Small Entities Affected: 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-AC09
_______________________________________________________________________




1173. CHARITABLE CHOICE PROVISIONS APPLICABLE TO THE TEMPORARY 
ASSISTANCE FOR NEEDY FAMILIES PROGRAM

Priority: Other Significant

Legal Authority: 42 USC 1302; 42 USC 604(a)

CFR Citation: 45 CFR 260.30; 45 CFR 260.34

Legal Deadline: None

Abstract: The proposed rule would implement the Charitable Choice 
statutory provisions at section 104 of the Personal Responsibility and 
Work Opportunity Reconciliation Act of 1996 as amended. It is the 
policy of the Administration for Children and Families that, within 
constitutional church-state guidelines, faith-based organizations 
should be able to compete on an equal footing for funding under the 
Temporary Assistance for Needy Families (TANF) program. In addition to 
giving families a greater choice of TANF-funded providers, these rules 
ensure that the character of religious providers is not impaired and 
that the religious freedom of TANF beneficiaries is not impaired.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/17/02                    67 FR 77362
NPRM Comment Period End         02/18/03
Final Rule                      12/00/03

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: State

Agency Contact: April Kaplan, Deputy Director, Office of Family 
Assistance, Department of Health and Human Services, Administration for 
Children and Families, 5th Floor East, 370 L'Enfant Promenade SW., 
Washington, DC 20447
Phone: 202 401-5138
Email: [email protected]

RIN: 0970-AC12
_______________________________________________________________________




1174. COMMUNITY SERVICES BLOCK GRANT CHARITABLE CHOICE

Priority: Substantive, Nonsignificant

Legal Authority: 42 USC 9901; PL 105-285, sec 672; 42 USC 9902; PL 105-
285, sec 673

CFR Citation: 45 CFR 1050

Legal Deadline: None

Abstract: This proposed rule would implement the Charitable Choice 
statutory provisions at section 679 of the Community Services Block 
Grant Act. These provisions apply to

[[Page 72919]]

programs authorized under the Act, including the Community Services 
Block grant program, Training, Technical Assistance and Capacity 
Building program, Community Food and Nutrition Program, National Youth 
Sports program, and discretionary grants for economic development, 
rural community development, and neighborhood innovation, which are all 
administered by the Administration for Children and Families (ACF). It 
is ACF's policy that, within the framework of constitutional church-
State guidelines, faith-based organizations should be able to compete 
on an equal footing for funding, and ACF supports the participation of 
faith-based organizations in these programs.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/17/02                    67 FR 77364
NPRM Comment Period End         02/18/03
Final Rule                      12/00/03

Regulatory Flexibility Analysis Required: No

Government Levels Affected: Federal

Agency Contact: Clarence Carter, Director, Office of Community 
Services, Department of Health and Human Services, Administration for 
Children and Families, 5th Floor East, 370 L'Enfant Promenade SW., 
Washington, DC 20447
Phone: 202 401-9333
Email: [email protected]

RIN: 0970-AC13
_______________________________________________________________________


Department of Health and Human Services (HHS)         Completed Actions


Administration for Children and Families (ACF)



_______________________________________________________________________




1175. CONSTRUCTION AND MAJOR RENOVATION OF HEAD START AND EARLY HEAD 
START FACILITIES

Priority: Other Significant

CFR Citation: 45 CFR 1309

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    05/01/03                    68 FR 23212

Regulatory Flexibility Analysis Required: No

Government Levels Affected: Local, Tribal

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

RIN: 0970-AB54
_______________________________________________________________________




1176. CHILD SUPPORT ENFORCEMENT PROGRAM OMNIBUS CONFORMING REGULATION

Priority: Substantive, Nonsignificant

CFR Citation: 45 CFR 301 to 305

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    05/12/03                    68 FR 25293

Regulatory Flexibility Analysis Required: No

Government Levels Affected: State

Agency Contact: Eileen C. Brooks
Phone: 202 401-5369
TDD Phone: 800 877-8339
Fax: 202 401-4054
Email: [email protected]

RIN: 0970-AB81
_______________________________________________________________________




1177. TECHNICAL REVISION OF HEAD START REGULATIONS TO MAKE THEM CONFORM 
TO RECENT STATUTORY REVISIONS

Priority: Substantive, Nonsignificant

CFR Citation: 45 CFR 1301 to 1303; 45 CFR 1305; 45 CFR 1308

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn                       08/29/03

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

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

RIN: 0970-AC00
_______________________________________________________________________




1178. CHILD SUPPORT ENFORCEMENT PROGRAM; EXPENDITURES FOR CASEWORKER 
COSTS

Priority: Substantive, Nonsignificant

CFR Citation: 45 CFR 304.23

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn                       08/29/03

Regulatory Flexibility Analysis Required: No

Government Levels Affected: State

Agency Contact: Sheck Chin
Phone: 202 260-5830
TDD Phone: 800 877-8339
Fax: 202 401-4054
Email: [email protected]

RIN: 0970-AC11

[[Page 72920]]

_______________________________________________________________________


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


Administration on Aging (AOA)



_______________________________________________________________________




1179. GRANTS FOR STATE AND COMMUNITY PROGRAMS ON AGING, TRAINING, 
RESEARCH, AND DISCRETIONARY PROGRAMS; VULNERABLE ELDER RIGHTS; 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 reauthorization of the Older Americans 
Act, Public Law 106-501, the Administration on Aging (AoA) proposes to 
issue a notice of proposed rulemaking by spring of 2004.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            05/00/04

Regulatory Flexibility Analysis Required: Yes

Government Levels Affected: State, Tribal

Federalism:  Undetermined

Agency Contact: Edwin Walker, Deputy Assistant Secretary for Policy and 
Programs, Department of Health and Human Services, Administration on 
Aging, Washington, DC 20201
Phone: 202 401-4634

RIN: 0985-AA00
[FR Doc. 03-27071 Filed 12-19-03; 8:45 am]
BILLING CODE 4150-24-S
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