[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 73120]]



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 this semiannual publication inventorying all rulemaking 
actions under development by the Department. The purpose is to 
encourage public participation in the regulatory process by providing, 
at as early a stage as possible, summarized information about 
regulatory actions under consideration. Anyone wishing to communicate 
to the Department their views on the potential rulemakings outlined 
below is invited to do so.

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

SUPPLEMENTARY INFORMATION: The capsulized information provided below 
presents for public scrutiny a forecast of the rulemaking activities 
that the Department expects to undertake over the foreseeable future.

    When the Department publishes a proposed rule, information 
about it automatically becomes available to the public at 
www.regulations.gov, the Governmentwide Web site for submission of 
comments on proposed regulations. Citizens may submit comments on 
such proposals by clicking the ``Submit a Comment on this 
Regulation'' link on the Web site, which will open a blank comment 
form containing instructions on how to submit the comment. Comments 
submitted via www.regulations.gov are transmitted to the Department 
daily, and, as legally required, all comments received are reviewed 
and taken into account if a final regulation is developed.

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

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

Dated: November 1, 2004.

 Ann C. Agnew,

Executive Secretary to the Department.

                                  Office of the Secretary--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
910         Health Insurance Portability and Accountability Act--Enforcement......................    0991-AB29
----------------------------------------------------------------------------------------------------------------


                                    Office of the Secretary--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
911         Shared Risk Exception to the Safe Harbor Provisions...................................    0991-AA91
912         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...............................................................................
913         Safe Harbor for Waiver of Beneficiary Coinsurance and Deductible Amounts for a            0991-AB16
            Medicare SELECT Policy................................................................
914         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                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
915         Revisions to Regulations Addressing the OIG's Authority to Impose Civil Money             0991-AB03
            Penalties and Assessments.............................................................
916         Claims Collection.....................................................................    0991-AB18
917         Salary Offset.........................................................................    0991-AB19
918         Medicare and Federal Health Care Programs: Fraud and Abuse; Revisions to the Waiver       0991-AB33
            Provisions of the OIG's Exclusion Authorities.........................................
----------------------------------------------------------------------------------------------------------------


[[Page 73121]]


                                   Office of the Secretary--Completed Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
919         Safe Harbor for Arrangements Involving Federally Qualified Health Centers.............    0991-AB06
920         Technical Revisions to HIPDB Data Collection Activities...............................    0991-AB31
921         Participation in Department of Health and Human Services Programs by Religious            0991-AB34
            Organizations; Providing for Equal Treatment of All Department of Health and Human
            Services Program Participants.........................................................
----------------------------------------------------------------------------------------------------------------


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


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


                         Centers for Disease Control and Prevention--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
924         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                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
925         Possession, Use, and Transfer of Select Agents and Toxins.............................    0920-AA09
----------------------------------------------------------------------------------------------------------------


                                   Food and Drug Administration--Prerule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
926         Food Labeling; Prominence of Calories (Reg Plan Seq No. 41)...........................    0910-AF22
927         Food Labeling; Serving Sizes of Products That Can Reasonably Be Consumed at One Eating    0910-AF23
            Occasion; Updating of Reference Amounts Customarily Consumed; Approaches for
            Recommending Smaller Portion Sizes (Reg Plan Seq No. 42)..............................
928         Over-the-Counter (OTC) Drug Review--Sunscreen Products................................    0910-AF43
----------------------------------------------------------------------------------------------------------------
References in boldface appear in the Regulatory Plan in part II of this issue of the Federal Register.


                                Food and Drug Administration--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
929         Foreign and Domestic Establishment Registration and Listing Requirements for Human        0910-AA49
            Drugs, Certain Biological Drugs, and Animal Drugs (Reg Plan Seq No. 43)...............

[[Page 73122]]

 
930         Medical Devices; Anesthesiology Devices; Proposed Reclassification of Pressure            0910-AC30
            Regulators for Use With Medical Oxygen................................................
931         Submission of Standardized Electronic Study Data From Clinical Studies Evaluating         0910-AC52
            Human Drugs and Biologics.............................................................
932         Medical Gas Containers and Closures; Current Good Manufacturing Practice Requirements.    0910-AC53
933         Food Standards: General Principles and Food Standards Modernization...................    0910-AC54
934         Positron Emission Tomography Drugs; Current Good Manufacturing Practices..............    0910-AC55
935         Reporting Information Regarding Falsification of Data.................................    0910-AC59
936         Health Claims.........................................................................    0910-AF09
937         Quality Standard Regulation Establishing an Allowable Level for Arsenic in Bottled        0910-AF10
            Water.................................................................................
938         Content and Format of Labeling for Human Prescription Drugs and Biologics;                0910-AF11
            Requirements for Pregnancy and Lactation..............................................
939         Cochineal Extract and Carmine Label Declaration.......................................    0910-AF12
940         Charging for Investigational Drugs....................................................    0910-AF13
941         Treatment Use of Investigational Drugs................................................    0910-AF14
942         Distribution of Blood Derivatives by Registered Blood Establishments That Qualify as      0910-AF16
            Health Care Entities; PDMA of 1987; PDA of 1992; Policies, Requirements, and
            Administrative Procedures.............................................................
943         Revocation of the Status of Specific Products; Group A Streptococcus..................    0910-AF20
944         Obstetrical and Gynecological Devices; Designation of Special Control for Condoms and     0910-AF21
            Condoms with Spermicidal Lubricant....................................................
945         Blood Initiative--Requirements for Human Blood and Blood Components Intended for          0910-AF25
            Transfusion or for Further Manufacturing Use..........................................
946         Over-the-Counter (OTC) Drug Review--Cough/Cold (Bronchodilator) Products..............    0910-AF32
947         Over-the-Counter (OTC) Drug Review--Cough/Cold (Combination) Products.................    0910-AF33
948         Over-the-Counter (OTC) Drug Review--Cough/Cold (Nasal Decongestant) Products..........    0910-AF34
949         Over-the-Counter (OTC) Drug Review--Internal Analgesic Products.......................    0910-AF36
950         Over-the-Counter (OTC) Drug Review--Labeling of Drug Products for OTC Human Use.......    0910-AF37
951         Over-the-Counter (OTC) Drug Review--Weight Control Products...........................    0910-AF45
952         Substances Prohibited From Use in Animal Food or Feed (Reg Plan Seq No. 44)...........    0910-AF46
953         Over-the-Counter (OTC) Drug Review--Dandruff, Seborrheic Dermatitis, and Psoriasis        0910-AF49
            Products..............................................................................
954         Over-the-Counter (OTC) Drug Review--Overindulgence in Food and Drink Products.........    0910-AF51
955         Over-the-Counter (OTC) Drug Review--Skin Bleaching Prodcuts...........................    0910-AF53
956         Use of Materials Derived From Cattle In Human and Animal Medical Products (Reg Plan       0910-AF54
            Seq No. 45)...........................................................................
957         Requirements for Human and Animal Medical Products Manufactured From, Processed With,     0910-AF55
            or Otherwise Containing Material From Cattle (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                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
958         Investigational New Drugs: Export Requirements for Unapproved New Drug Products.......    0910-AA61
959         Requirements on Content and Format of Labeling for Human Prescription Drugs and           0910-AA94
            Biological Products (Reg Plan Seq No. 47).............................................
960         Safety Reporting Requirements for Human Drug and Biological Products (Reg Plan Seq No.    0910-AA97
            48)...................................................................................
961         Current Good Tissue Practice for Human Cell, Tissue, and Cellular and Tissue-Based        0910-AB28
            Product Establishments; Inspection and Enforcement (Reg Plan Seq No. 49)..............
962         Applications for FDA Approval To Market a New Drug; Complete Response Letter;             0910-AB34
            Amendments To Unapproved Applications.................................................
963         CGMPs for Blood and Blood Components: Notification of Consignees and Transfusion          0910-AB76
            Recipients Receiving Blood and Blood Components at Increased Risk of Transmitting HCV
            Infection (Lookback) (Reg Plan Seq No. 50)............................................
964         Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Dietary         0910-AB88
            Ingredients and Dietary Supplements (Reg Plan Seq No. 51).............................
965         Additional Safeguards for Children in Clinical Investigations of FDA-Regulated            0910-AC07
            Products..............................................................................
966         Prevention of Salmonella Enteritidis in Shell Eggs (Reg Plan Seq No. 52)..............    0910-AC14
967         Institutional Review Boards: Registration Requirements................................    0910-AC17
968         Medical Devices; Patient Examination and Surgeons' Gloves; Adulteration...............    0910-AC32

[[Page 73123]]

 
969         Amendments to the Performance Standard for Diagnostic X-Ray Systems and Their Major       0910-AC34
            Components............................................................................
970         Toll-Free Number for Reporting Adverse Events on Labeling for Human Drugs (Reg Plan       0910-AC35
            Seq No. 53)...........................................................................
971         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. 54)..............
972         Registration of Food and Animal Feed Facilities (Reg Plan Seq No. 55).................    0910-AC40
973         Prior Notice of Imported Food Under the Public Health Security and Bioterrorism           0910-AC41
            Preparedness and Response Act of 2002 (Reg Plan Seq No. 56)...........................
974         Human Subject Protection; Foreign Clinical Studies Not Conducted Under an                 0910-AF15
            Investigational New Drug Application..................................................
975         Use of Ozone-Depleting Substances: Removal of Essential Use Designation; Albuterol        0910-AF18
            (Reg Plan Seq No. 57).................................................................
976         Blood Initiative--Revisions to Labeling and Storage Requirements for Blood and Blood      0910-AF26
            Components, Including Source Plasma...................................................
977         Current Good Manufacturing Practices; Quality Control Procedures; Notification            0910-AF27
            Requirements; Records and Reports.....................................................
978         Infant Formula Quality Factors........................................................    0910-AF28
979         Over-the-Counter (OTC) Drug Review--Cough/Cold (Antihistamine) Products...............    0910-AF31
980         Over-the-Counter (OTC) Drug Review--Ophthalmic Products...............................    0910-AF39
981         Over-the-Counter (OTC) Drug Review--Skin Protectant Products..........................    0910-AF42
982         Over-the-Counter (OTC) Drug Review--Vaginal Contraceptive Products....................    0910-AF44
983         Use of Materials Derived From Cattle in Human Food and Cosmetics (Reg Plan Seq No. 58)    0910-AF47
984         Recordkeeping Requirements for Human Food and Cosmetics Manufactured From, Processed      0910-AF48
            With, or Otherwise Containing Material From Cattle (Reg Plan Seq No. 59)..............
985         Over-the-Counter (OTC) Drug Review--Antacid Products (Sodium Bicarbonate Labeling)....    0910-AF52
----------------------------------------------------------------------------------------------------------------
References in boldface appear in the Regulatory Plan in part II of this issue of the Federal Register.


                                 Food and Drug Administration--Long-Term Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
986         Requirements Pertaining to Sampling Services and Private Laboratories Used in             0910-AB96
            Connection With Imported Food.........................................................
987         Chronic Wasting Disease: Control of Food Products and Cosmetics Derived From Exposed      0910-AC21
            Animal Populations....................................................................
988         Requirements for Submission of In Vivo Bioequivalence Data............................    0910-AC23
989         Exception From General Requirements for Informed Consent; Request for Comments and        0910-AC25
            Information...........................................................................
990         Food Labeling: Trans Fatty Acids in Nutrition Labeling: Consumer Research To Consider     0910-AC50
            Nutrient Content and Health Claims and Possible Footnote or Disclosure Statements.....
991         Food Labeling: Food Allergen Ingredient Labeling......................................    0910-AF07
992         Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding     0910-AF08
            of Drugs; Revision of Certain Labeling Controls.......................................
993         Over-the-Counter (OTC) Drug Review--External Analgesic Products.......................    0910-AF35
994         Over-the-Counter (OTC) Drug Review--Laxative Drug Products............................    0910-AF38
995         Over-the-Counter (OTC) Drug Review--Oral Health Care Products.........................    0910-AF40
----------------------------------------------------------------------------------------------------------------


                                 Food and Drug Administration--Completed Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
996         Presubmission Conferences.............................................................    0910-AC44
997         Definition of ``Serious Adverse Health Consequences'' Under the Public Health Security    0910-AF06
            and Bioterrorism Preparedness and Response Act of 2002................................
998         Over-the-Counter (OTC) Drug Review--Antiperspirant Products...........................    0910-AF30
999         Over-the-Counter (OTC) Drug Review--Sodium Labeling for Over-the Counter Drugs........    0910-AF50
----------------------------------------------------------------------------------------------------------------


[[Page 73124]]


                        Health Resources and Services Administration--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
1000        National Practitioner Data Bank for Adverse Information on Physicians and Other Health    0906-AA41
            Care Practitioners: Medical Malpractice Payments Reporting Requirements...............
1001        Designation of Medically Underserved Populations and Health Professional Shortage         0906-AA44
            Areas.................................................................................
1002        Intestines Added to the Definition of Organs Covered by the Rules Governing the           0906-AA62
            Operation of the Organ Procurement and Transplantation Network (OPTN).................
1003        National Vaccine Injury Compensation Program; Revisions and Additions to the Vaccine      0906-AA66
            Injury Table..........................................................................
1004        National Vaccine Injury Compensation Program: Calculation of Average Cost of a Health     0906-AA68
            Insurance Policy......................................................................
1005        Revision to 42 CFR Subpart D--Public Health Service (PHS) Grant Appeals Procedure.....    0906-AA69
1006        Healthy Tomorrow's Partnership for Children (HTPC) Program............................    0906-AA70
----------------------------------------------------------------------------------------------------------------


                         Health Resources and Services Administration--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
1007        Interim Final Rule for the Smallpox Emergency Personnel Protection Program: Smallpox      0906-AA60
            (Vaccinia) Vaccine Injury Table.......................................................
1008        Smallpox Vaccine Injury Compensation Program: Administrative Implementation...........    0906-AA61
1009        Requirements Establishing a Limitation on Administrative Expenses; Ryan White CARE Act    0906-AA65
            Title IV Grants for Coordinated Services and Access to Research.......................
----------------------------------------------------------------------------------------------------------------


                         Health Resources and Services Administration--Long-Term Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
1010        National Practitioner Data Bank for Adverse Information on Physicians and Other Health    0906-AA57
            Care Practitioners: Reporting Adverse and Negative Actions............................
1011        Operation of the Organ Procurement and Transplantation Network (OPTN).................    0906-AA63
----------------------------------------------------------------------------------------------------------------


                         Health Resources and Services Administration--Completed Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
1012        Liability Protection for Certain Free Clinic Health Professionals.....................    0906-AA67
----------------------------------------------------------------------------------------------------------------


                               National Institutes of Health--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
1013        Undergraduate Scholarship Program Regarding Professions Needed by the National            0925-AA10
            Institutes of Health (NIH)............................................................
1014        National Institutes of Health Training Grants.........................................    0925-AA28
1015        Standards for a National Chimpanzee Sanctuary System..................................    0925-AA31
1016        National Institutes of Health AIDS Research Loan Repayment Program....................    0925-AA32
1017        National Institutes of Health Extramural Loan Repayment Program for Clinical              0925-AA33
            Researchers...........................................................................
1018        National Institutes of Health Pediatric Research Loan Repayment Program...............    0925-AA34
1019        National Institutes of Health Loan Repayment Program for Health Disparities Research..    0925-AA35
1020        National Institutes of Health Clinical Research Loan Repayment Program for Individuals    0925-AA36
            From Disadvantaged Backgrounds........................................................
1021        National Institute of Child Health and Human Development Contraception and Infertility    0925-AA41
            Research Loan Repayment Program.......................................................
----------------------------------------------------------------------------------------------------------------


[[Page 73125]]


                                 National Institutes of Health--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
1022        National Institutes of Health Loan Repayment Program for Research Generally...........    0925-AA18
----------------------------------------------------------------------------------------------------------------


                                National Institutes of Health--Completed Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
1023        National Institutes of Health Center Grants...........................................    0925-AA24
----------------------------------------------------------------------------------------------------------------


                               Office of Public Health and Science--Prerule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
1024        Human Subjects Protection Regulations: Additional Protections for Adult Individuals       0940-AA11
            With Impaired Decisionmaking Capacity.................................................
----------------------------------------------------------------------------------------------------------------


                              Office of Public Health and Science--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
1025        Public Health Service Standards for the Protection of Research Misconduct                 0940-AA01
            Whistleblowers........................................................................
1026        Public Health Service Policies on Research Misconduct.................................    0940-AA04
1027        Human Subjects Protection Regulations: Institutional Review Boards Registration           0940-AA06
            Requirements..........................................................................
1028        Federal Policy for the Protection of Human Subjects Technical Amendment...............    0940-AA10
----------------------------------------------------------------------------------------------------------------


                             Office of Public Health and Science--Long-Term Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
1029        Human Subjects Protection Regs.: Training and Education Requirements for Institutional    0940-AA08
            Officials, Institutional Review Board Members and Staff, Human Protections
            Administrators, and Investigators.....................................................
----------------------------------------------------------------------------------------------------------------


                          Centers for Medicare & Medicaid Services--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
1030        Home Health Agency (HHA) Conditions of Participation (CoPs) (CMS-3819-P)..............    0938-AG81
1031        End Stage Renal Disease (ESRD) Conditions for Coverage (CMS-3818-P) (Section 610          0938-AG82
            Review) (Reg Plan Seq No. 60).........................................................
1032        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. 61)....
1033        Hospice Care--Conditions of Participation (CMS-3844-P) (Reg Plan Seq No. 62)..........    0938-AH27
1034        Standard Unique National Health Plan Identifiers (CMS-6017-P).........................    0938-AH87
1035        Appeals of Carrier Determination That a Supplier Fails To Meet the Requirements for       0938-AI49
            Medicare Billing Privileges (CMS-6003-P2).............................................
1036        Rural Health Clinics: Amendments to Participation Requirements and Payment Provisions     0938-AJ17
            and Establishment of a Quality Assessment and Improvement Program (CMS-1910-P2).......
1037        Supplier Standards for Home Oxygen, Therapeutic Shoes, and Home Nutrition Therapy (CMS-   0938-AJ98
            6010-P)...............................................................................
1038        Standards for Electronic Health Care Claim Attachments(CMS-0050-P)....................    0938-AK62
1039        Organ Procurement Organization Conditions for Coverage (CMS-3064-P) (Reg Plan Seq No.     0938-AK81
            63)...................................................................................

[[Page 73126]]

 
1040        Use of Restraint and Seclusion in Medicare and Medicaid Participating Facilities That     0938-AL26
            Provide Inpatient or Residential Care (CMS-2130-P) (Reg Plan Seq No. 64)..............
1041        Revisions to Conditions for Coverage for Ambulatory Surgical Centers (CMS-3887-P).....    0938-AL80
1042        Health Coverage Portability: Tolling Certain Time Periods and Interactions With Family    0938-AL88
            and Medical Leave Act (CMS-2158-P)....................................................
1043        Modifications to Electronic Transactions and Code Sets (CMS-0009-P)...................    0938-AM50
1044        Requirements for Long-Term Care Facilities: Hospice Services (CMS-3140-P).............    0938-AM87
1045        Hospital Conditions of Participation: Requirements for History and Physical               0938-AM88
            Examinations; Authentication of Verbal Orders; Securing Medications; and Post-
            Anesthesia Evaluations (CMS-3122-P)...................................................
1046        Physician Referral for Nuclear Medicine Services and Supplies (CMS-1261-P)............    0938-AN04
1047        Enhanced DSH Treatment for Certain Hospitals (CMS-2198-P).............................    0938-AN09
1048        Prior Determination Process for Certain Items and Services (CMS-6024-P)...............    0938-AN10
1049        Competitive Acquisition for Certain Durable Medical Equipment (DME), Prosthetics,         0938-AN14
            Orthotics, and Supplies (CMS-1270-P)..................................................
1050        Update of the List of Covered Procedures for Ambulatory Surgical Centers for 2005 (CMS-   0938-AN23
            1478-PN)..............................................................................
1051        Revisions to HIPAA Code Sets (CMS-0013-P).............................................    0938-AN25
1052        Payment for Clinical Laboratory Tests (CMS-1494-P)....................................    0938-AN26
1053        Prospective Payment System for Long Term Care Hospitals: Annual Payment Rate Updates      0938-AN28
            and Policy Changes for 2006 (CMS-1483-P)..............................................
1054        Random Prepayment Review (CMS-6022-P).................................................    0938-AN31
1055        Repayment Plans and Limitation on Recoupment of Overpayments (CMS-6025-P).............    0938-AN42
1056        Prospective Payment System for Inpatient Rehabilitation Facilities for FY 2006 (CMS-      0938-AN43
            1290-P)...............................................................................
1057        Home Health Prospective Payment System Rate Update for Calendar Year 2006 (CMS-1301-P)    0938-AN44
1058        Changes to the Hospital Outpatient Prospective Payment System and Calendar Year 2006      0938-AN46
            Payment Rates (CMS-1501-P)............................................................
1059        Revised Civil Money Penalties, Assessments, Exclusions, and Related Appeals Procedures    0938-AN48
            (CMS-6019-P)..........................................................................
1060        Medicare Modernization Act; Electronic Prescribing (CMS-0011-P).......................    0938-AN49
1061        Furnishing Hospitals With Information To Compute the Disproportionate Share Hospital      0938-AN52
            Formula (CMS-1283-P)..................................................................
1062        End Stage Renal Disease (ESRD) Composite Rate Exception (CMS-1278-P)..................    0938-AN53
1063        Changes to the Hospital Inpatient Prospective Payment System and FY 2006 Rates (CMS-      0938-AN57
            1500-P)...............................................................................
1064        Medicare Part B Competitive Acquisition of Outpatient Drugs and Biologicals (CMS-1325-    0938-AN58
            P)....................................................................................
1065        Revisions to the Oversight and Validation Program for Accrediting Organizations           0938-AN62
            Approved for Deeming Authority (CMS-2255-P) (Reg Plan Seq No. 65).....................
1066        Special Payment Provisions and Standards for Suppliers of Custom Fabricated Orthotics     0938-AN63
            and Prosthetics (CMS-6012-P)..........................................................
1067        Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities--      0938-AN65
            Update for FY 2006 (CMS-1282-P).......................................................
----------------------------------------------------------------------------------------------------------------
References in boldface appear in the Regulatory Plan in part II of this issue of the Federal Register.


                           Centers for Medicare & Medicaid Services--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
1068        Hospital Conditions of Participation: Laboratory Services (CMS-3014-IFC)..............    0938-AJ29
1069        Health Coverage Portability for Group Health Plans and Group Health Insurance Issuers     0938-AL43
            (CMS-2151-F)..........................................................................
1070        Prospective Payment System for Inpatient Psychiatric Facilities for FY 2004 (CMS-1213-    0938-AL50
            F)....................................................................................
1071        Request for Information on Benefit-Specific Waiting Periods (CMS-2150-NC).............    0938-AL64
1072        Revisions to the Medicare Appeals Process (CMS-4004-FC)...............................    0938-AL67
1073        Revisions to the Appeals Process for Initial Claim Determinations (CMS-4064-IFC)......    0938-AM73
1074        Conditions for Coverage of Power Mobility Devices, including Powered Wheelchairs and      0938-AM74
            Power-Operated Vehicles Scooter(CMS-3017-IFC).........................................
1075        Changes to the Hospital Outpatient Prospective System and Calendar Year 2005 Payment      0938-AM75
            Rates (CMS-1427-FC)...................................................................
1076        Revisions to Payment Policies Under the Physician Fee Schedule for Calendar Year 2005     0938-AM90
            (CMS-1429-FC).........................................................................
1077        Medicare Advantage Program--Title II (CMS-4069-F) (Reg Plan Seq No. 66)...............    0938-AN06
1078        Medicare Drug Benefit Effective Calendar Year 2006--Title I (CMS-4068-F) (Reg Plan Seq    0938-AN08
            No. 67)...............................................................................
1079        Schedule for Publishing Medicare Final Regulations After a Proposed or Interim Final      0938-AN12
            Regulation (CMS-9026-N)...............................................................
1080        Evaluation Criteria and Standards for Quality Improvement Program Contracts (CMS-3142-    0938-AN13
            NC)...................................................................................

[[Page 73127]]

 
1081        Medicare Secondary Payer (MSP): Workmen's Compensation (CMS-6272-IFC).................    0938-AN27
1082        Fire Safety Requirements for Certain Health Care Facilities; Alcohol-Based Hand           0938-AN36
            Sanitizer Amendment (CMS-3145-IFC)....................................................
1083        Modifications to Managed Care Rules (CMS-4041-IFC)....................................    0938-AN38
1084        Development of New Standards for Medigap Policies (CMS-2197-FN).......................    0938-AN50
1085        Time Limitation on Recordkeeping Requirements Under the Drug Rebate Program (CMS-2175-    0938-AN55
            F)....................................................................................
1086        Fiscal Year 2006 SCHIP Allotments (CMS-2219-N)........................................    0938-AN56
----------------------------------------------------------------------------------------------------------------
References in boldface appear in the Regulatory Plan in part II of this issue of the Federal Register.


                           Centers for Medicare & Medicaid Services--Long-Term Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
1087        Requirements for Establishing and Maintaining Medicare Billing Privileges (CMS-6002-F)    0938-AH73
1088        Medicare Outcome and Assessment Information Set (OASIS) Data Reporting Requirements       0938-AJ10
            (CMS-3006-F)..........................................................................
1089        Medicare Hospice Care Amendments (CMS-1022-F).........................................    0938-AJ36
1090        Use of Restraint and Seclusion in Residential Treatment Facilities Providing Inpatient    0938-AJ96
            Psychiatric Services to Individuals Under Age 21 (CMS-2065-F).........................
1091        Physicians' Referrals to Health Care Entities With Which They Have Financial              0938-AK67
            Relationships--Phase II (CMS-1810-IFC)................................................
1092        Provider Reimbursement Determinations and Appeals (CMS-1727-F)........................    0938-AL54
1093        DMERC Service Areas and Related Matters (CMS-1219-F)..................................    0938-AL76
1094        Electronic Medicare Claims Submission (CMS-0008-F)....................................    0938-AM22
1095        Procedures for Maintaining Code Lists in the Negotiated National Coverage                 0938-AM36
            Determinations for Clinical Diagnostic Laboratory Services (CMS-3119-FN)..............
1096        Requirements for Long Term Care Facilities; Nursing Services; Posting of Nurse            0938-AM55
            Staffing Information (CMS-3121-F).....................................................
1097        Revised Civil Money Penalties, Assessments, Exclusions, and Related Appeals Procedures    0938-AM98
            (CMS-6146-F)..........................................................................
1098        Payment for Respiratory Assist Devices With Bi-Level Capability and a Back-Up Rate        0938-AN02
            (CMS-1167-F)..........................................................................
1099        Nondiscrimination In Post-Hospital Referral to Home Health Agencies and Other Entities    0938-AN19
            (CMS-1224-F)..........................................................................
1100        Medicare Ambulance Fee Schedule Update (CMS-1492-F)...................................    0938-AN24
1101        Nondiscrimination in Health Coverage and Wellness Plans in the Group Market (CMS-2022-    0938-AN29
            F)....................................................................................
1102        Hospital Conditions of Participation: Patients' Rights (CMS-3018-F)...................    0938-AN30
1103        Federal Enforcement in Group and Individual Health Insurance Markets (CMS-2019-F).....    0938-AN35
1104        Group Market Health Insurance Reform: Guaranteed Availability, Guaranteed                 0938-AN60
            Renewability, Disclosures to Small Employers (CMS-2216-F).............................
1105        Individual Market Health Insurance Reform: Portability From Group to Individual           0938-AN61
            Coverage; Federal Rules for Access in the Individual Market; State Alternative
            Mechanisms to Federal Rules (CMS-2217-F)..............................................
----------------------------------------------------------------------------------------------------------------


                           Centers for Medicare & Medicaid Services--Completed Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
1106        Continuation of Medicare Entitlement When Disability Benefit Ends Because of              0938-AK94
            Substantial Gainful Activity (CMS-4018-F).............................................
1107        Interest Calculation (CMS-6014-F).....................................................    0938-AL14
1108        Hospital Patients' Rights CoP--Standard Safety Compliance Committees (CMS-3120-P).....    0938-AM39
1109        Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities--      0938-AM46
            Update for FY 2006 (CMS-1249-N).......................................................
1110        Title I: Non-Federal Governmental Plans Exempt From HIPAA (CMS-2033-F)................    0938-AM71
1111        Hospice Wage Index FY 2005 (CMS-1264-N)...............................................    0938-AM78
1112        Ticket to Work: Defining Individuals with Potentially Severe Disabilities and             0938-AM79
            Providing a Work Threshold (CMS-2172-P)...............................................
1113        Changes to the Hospital Inpatient Prospective Payment System and FY 2005 Rates (CMS-      0938-AM80
            1428-F)...............................................................................
1114        Covered Outpatient Drugs Under the Medicaid Drug Rebate Program (CMS-2174-P)..........    0938-AM81

[[Page 73128]]

 
1115        Prospective Payment System for Inpatient Rehabilitation Facilities for FY 2005 (CMS-      0938-AM82
            1360-N)...............................................................................
1116        Payment Error Rate Measurement (PERM) Program (CMS-6026-P)............................    0938-AM86
1117        Home Health Prospective Payment System Rate Update FY 2005 (CMS-1265-F)...............    0938-AM93
1118        Revisions to Cost Sharing Regulations (CMS-2144-P)....................................    0938-AM94
1119        Medicare Program; Hospital Outpatient Prospective Payment System Payment Reform for       0938-AM96
            Calendar Year 2004 CMS-1371-F.........................................................
1120        Changes to Medicare Payment for Drugs and Physician Fee Schedule Payments for Calendar    0938-AM97
            Year 2004--Correction Notice CMS-1372-F)..............................................
1121        Physicians' Referrals to Health Care Entities With Which They Have Financial              0938-AM99
            Relationships: Extension of Partial Delay of Effective Date (CMS-1809-F5).............
1122        Time Limitation on Recordkeeping Requirements Under the Drug Rebate Program (CMS-2188-    0938-AN01
            P)....................................................................................
1123        Extended Availability of Unexpended SCHIP Funds From the Appropriation for FYs 1998       0938-AN03
            Through 2004; Authority To Use a Portion of SCHIP Funds for Medicaid Expenditures (CMS-
            2187-N)...............................................................................
1124        Manufacturers' Submission of Average Sales Price Data for Medicare Part B Drugs and       0938-AN05
            Biologicals (CMS-1380-F)..............................................................
1125        Special Rules for Employer-Sponsored Drug Programs: Subsidies To Encourage Retention      0938-AN07
            (Title I) (CMS-2199-P)................................................................
1126        FY 2005 SCHIP Allotments (CMS-2201-N).................................................    0938-AN11
1127        Part A Premiums for Calendar Year 2005 for the Uninsured Aged and for Certain Disabled    0938-AN15
            Individuals Who Have Exhausted Other Entitlement (CMS-8022-N).........................
1128        Inpatient Hospital Deductible and Hospital and Extended Care Services Coinsurance         0938-AN16
            Amounts for Calendar Year 2005 (CMS-8021-N)...........................................
1129        Medicare Part B Monthly Actuarial Rates and Premium Rate Beginning January 1, 2005        0938-AN18
            (CMS-8020-N)..........................................................................
1130        Fee Schedule for Payment of Ambulance Services-Update for Calendar Year 2005 (CMS-1267-   0938-AN20
            N)....................................................................................
1131        Procedure for Producing Guidance Documents Describing Medicare's Coverage Process (CMS-   0938-AN21
            3141-N)...............................................................................
1132        Amendment to the Interim Final Regulation for Mental Health Parity (CMS-2152-F2)......    0938-AN22
1133        Pharmacy Dispensing Fee (CMS-1280-F)..................................................    0938-AN34
----------------------------------------------------------------------------------------------------------------


                          Administration for Children and Families--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
1134        Safeguarding Child Support and Expanded Federal Parent Locator Services (FPLS)            0970-AC01
            Information...........................................................................
1135        Developmental Disabilities and Bill of Rights Act.....................................    0970-AC07
1136        Administrative Costs for Children in Title IV-E Foster Care...........................    0970-AC14
1137        Administrative Cost Sharing Under TANF................................................    0970-AC15
1138        Child Care and Development Fund State Match Provisions................................    0970-AC18
----------------------------------------------------------------------------------------------------------------


                           Administration for Children and Families--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
1139        Head Start Transportation.............................................................    0970-AC16
1140        Reasonable Quantitative Standard for Review and Adjustment of Child Support Orders....    0970-AC19
----------------------------------------------------------------------------------------------------------------


                           Administration for Children and Families--Completed Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
1141        Child Support Enforcement Program; Federal Tax Refund Offset..........................    0970-AC09
----------------------------------------------------------------------------------------------------------------


[[Page 73129]]


                                  Administration on Aging--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
1142        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)



_______________________________________________________________________




910. HEALTH INSURANCE PORTABILITY AND ACCOUNTABILITY ACT--ENFORCEMENT

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

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

CFR Citation: 45 CFR 160, subparts C to E

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            02/00/05

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: None

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

RIN: 0991-AB29
_______________________________________________________________________


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


Office of the Secretary (OS)



_______________________________________________________________________




911. SHARED RISK EXCEPTION TO THE SAFE HARBOR PROVISIONS

Priority: Substantive, Nonsignificant

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

CFR Citation: 42 CFR 1001

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

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

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

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

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




912. 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. Major status under 5 USC 801 is 
undetermined.

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.

[[Page 73130]]

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/06/00                    65 FR 76460
Final Action                    03/00/05

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses, Governmental Jurisdictions, 
Organizations

Government Levels Affected: Federal, Local, State, 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
_______________________________________________________________________




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

Priority: Substantive, Nonsignificant

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

CFR Citation: 42 CFR 1001

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/25/02                    67 FR 60202
NPRM Comment Period End         10/25/02
Final Action                    04/00/05

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

RIN: 0991-AB16
_______________________________________________________________________




914. 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 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                    04/00/05

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 (OIG), 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)



_______________________________________________________________________




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

RIN: 0991-AB03

[[Page 73131]]

_______________________________________________________________________




916. CLAIMS COLLECTION

Priority: Substantive, Nonsignificant

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

CFR Citation: 45 CFR 30

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            07/13/04                    69 FR 42010
Final Action                     To Be                       Determined

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

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

RIN: 0991-AB18
_______________________________________________________________________




917. SALARY OFFSET

Priority: Substantive, Nonsignificant

Unfunded Mandates: Undetermined

Legal Authority: 5 USC 5514; 5 CFR 550

CFR Citation: 45 CFR 33

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            07/13/04
Final Action                     To Be                       Determined

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

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

RIN: 0991-AB19
_______________________________________________________________________




918. MEDICARE AND FEDERAL HEALTH CARE PROGRAMS: FRAUD AND ABUSE; 
REVISIONS TO THE WAIVER PROVISIONS OF THE OIG'S EXCLUSION AUTHORITIES

Priority: Substantive, Nonsignificant

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

CFR Citation: 42 CFR 1001

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                             To Be                       Determined

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: Federal

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

RIN: 0991-AB33
_______________________________________________________________________


Department of Health and Human Services (HHS)         Completed Actions


Office of the Secretary (OS)



_______________________________________________________________________




919. SAFE HARBOR FOR ARRANGEMENTS INVOLVING FEDERALLY QUALIFIED HEALTH 
CENTERS

Priority: Substantive, Nonsignificant

CFR Citation: 42 CFR 1001

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn - Superceded by 0991-
AB37                            09/07/04

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

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

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




920. TECHNICAL REVISIONS TO HIPDB DATA COLLECTION ACTIVITIES

Priority: Substantive, Nonsignificant

CFR Citation: 45 CFR 61

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              06/17/04                    69 FR 33866

[[Page 73132]]

Interim Final Rule Comment 
Period End                      07/19/04
Final Action                    11/02/04

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

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

RIN: 0991-AB31
_______________________________________________________________________




921.  PARTICIPATION IN DEPARTMENT OF HEALTH AND HUMAN 
SERVICES PROGRAMS BY RELIGIOUS ORGANIZATIONS; PROVIDING FOR EQUAL 
TREATMENT OF ALL DEPARTMENT OF HEALTH AND HUMAN SERVICES PROGRAM 
PARTICIPANTS

Priority: Substantive, Nonsignificant

Legal Authority: 5 USC 301

CFR Citation: 45 CFR 74

Legal Deadline: None

Abstract: This rulemaking completes the Department's effort to 
implement executive branch policy that, within the framework of 
constitutional church-state guidelines, religiously affiliated (or 
``faith-based'') organizations should be able to compete on an equal 
footing with other organizations for the Department's funding without 
impairing the religious character of such organizations. It revises 
Department regulations to remove barriers to the participation of 
faith-based organizations in Department programs, and to ensure that 
these programs are implemented in a manner consistent with applicable 
statutes and the requirements of the Constitution.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            03/09/04                    69 FR 10991
Final Action                    07/16/04                    69 FR 42586

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Bobby Polito, Director, Center for Faith-Based and 
Community Initiatives, Department of Health and Human Services, Room 
120F, 200 Independence Avenue NW., Washington, DC 20201
Phone: 202 358-3595

Related RIN: Previously reported as 0991-AB32
RIN: 0991-AB34
_______________________________________________________________________


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


Substance Abuse and Mental Health Services Administration (SAMHSA)



_______________________________________________________________________




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

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

Legal Authority: PL 106-310

CFR Citation: Not Yet Determined

Legal Deadline: NPRM, Statutory, April 2001.

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            04/00/05

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: State

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

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

RIN: 0930-AA10
_______________________________________________________________________


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


Substance Abuse and Mental Health Services Administration (SAMHSA)



_______________________________________________________________________




923. MANDATORY GUIDELINES FOR THE FEDERAL WORKPLACE DRUG TESTING PROGRAM

Priority: Other Significant

Legal Authority: PL 100-71; 5 USC 7301

CFR Citation: None

Legal Deadline: NPRM, Statutory, December 2003.

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

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

[[Page 73133]]

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
_______________________________________________________________________


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


Centers for Disease Control and Prevention (CDC)



_______________________________________________________________________




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

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

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

CFR Citation: 42 CFR 84

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            02/00/05

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected:  Businesses

Government Levels Affected: None

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

RIN: 0920-AA04
_______________________________________________________________________


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


Centers for Disease Control and Prevention (CDC)



_______________________________________________________________________




925.  POSSESSION, USE, AND TRANSFER OF SELECT AGENTS 
AND TOXINS

Priority: Other Significant

Legal Authority: PL 107-188

CFR Citation: 42 CFR 72; 42 CFR 72.6

Legal Deadline: None

Abstract: Title II of subtitle B of Public Law 107-188, the Public 
Health Security and Bioterrorism Preparedness and Response Act of 2002 
(the Bioterrorism Act), repeals, expands, and incorporates the 
Secretary's current authority to regulate the transfer of certain 
biological agents and toxins (select agents). The Bioterrorism Act 
specifies that the Secretary develop and biennially review a specified 
list of select agents. Safety procedures must be established and 
enforced for the possession, use, and transfer of the listed agents and 
toxins; access to select agents is limited to individuals and entities 
that pass background checks administered by the Attorney General. The 
Bioterrorism Act exempts certain information from disclosure under the 
Freedom of Information Act, including information that would identify 
the location of regulated entities or their security measures. Subtitle 
C of the Bioterrorism Act outlines the required interagency 
coordination between the Department of Health and Human Services and 
the Department of Agriculture regarding agents that are regulated by 
both departments (overlap agents). This action will bring to completion 
the Department's rulemaking in this area.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Action                    01/00/05

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Additional Information: Under RIN 0920-AA08, this regulation published 
as an interim final rule on December 13, 2002, at 67 FR 76886. An 
amended interim final rule with a request for comments was also 
published on November 3, 2003, at 68 FR 62245. Subsequently, RIN 0920-
AA08 was inadvertently completed in the april 2003 Unified Agenda.

Agency Contact: Mark Hemphill, Chief of Policy, Select Agent Program, 
Department of Health and Human Services, Centers for Disease Control 
and Prevention, 1600 Clifton Rd, MS E-79, Atlanta, GA 30333
Phone: 404 498-2255

Related RIN: Previously reported as 0920-AA08
RIN: 0920-AA09

[[Page 73134]]

_______________________________________________________________________


Department of Health and Human Services (HHS)             Prerule Stage


Food and Drug Administration (FDA)



_______________________________________________________________________




926. FOOD LABELING; PROMINENCE OF CALORIES

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

RIN: 0910-AF22
_______________________________________________________________________




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

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

RIN: 0910-AF23
_______________________________________________________________________




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

Priority: Routine and Frequent

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

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

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

ANPRM (Sunscreen and Insect 
Repellent)                      01/00/05
NPRM (UVA/UVB)                  03/00/05

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: None

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

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


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


Food and Drug Administration (FDA)



_______________________________________________________________________




929. FOREIGN AND DOMESTIC ESTABLISHMENT REGISTRATION AND LISTING 
REQUIREMENTS FOR HUMAN DRUGS, CERTAIN BIOLOGICAL DRUGS, AND ANIMAL DRUGS

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

RIN: 0910-AA49
_______________________________________________________________________




930. 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                            12/00/04

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, HFZ-215, 1350 Piccard 
Drive, Rockville, MD 20850
Phone: 301 827-2974
Fax: 301 594-4765
Email: [email protected]

RIN: 0910-AC30
_______________________________________________________________________




931. 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

[[Page 73135]]

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 that 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                            06/00/05

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

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), Center for Drug Evaluation and Research, 5515 Security Lane, 
Suite 1101 (HFD-7), Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 594-6197
Email: [email protected]

RIN: 0910-AC52
_______________________________________________________________________




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

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

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

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

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/00/05

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: None

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

RIN: 0910-AC53
_______________________________________________________________________




933. FOOD STANDARDS: GENERAL PRINCIPLES AND FOOD STANDARDS MODERNIZATION

Priority: Other Significant

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

CFR Citation: 21 CFR 130.5

Legal Deadline: None

Abstract: In 1995, the FDA and FSIS reviewed their regulatory 
procedures and requirements for food standards to determine whether any 
were still needed, and if so, which ones should be modified or 
streamlined. To request public comment to assist them in their review 
of the need for food standards, both agencies published advance notices 
of proposed rulemaking (ANPRMs) on food standards in December, 1995 (60 
FR 47453 and 60 FR 67492). These ANPRMs discussed the agencies' 
regulations and policy governing food standards, the history of food 
standards, and the possible need to revise the food standards. Several 
comments in response to the ANPRMs recommended that the agencies 
establish general principles or a fundamental philosophy for reviewing 
food standards and revising them. The agencies agreed with these 
comments and determined that it would be appropriate to develop general 
principles for reviewing and revising food standards regulations. The 
agencies also agreed with the comments that stated that the agencies 
should work in concert to develop 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                            12/00/04

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: Undetermined

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

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

[[Page 73136]]

_______________________________________________________________________




934. 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 212

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

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            01/00/05

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Governmental Jurisdictions

Government Levels Affected: Federal, State

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

Agency Contact: Wayne H. Mitchell, Regulatory Counsel, Office of 
Regulatory Policy, Department of Health and Human Services, Food and 
Drug Administration, Suite 3037 (HFD-7), Center for Drug Evaluation and 
Research, 5515 Security Lane, Suite 1101 (HFD-7), Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562
Email: [email protected]

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




935. REPORTING INFORMATION REGARDING FALSIFICATION OF DATA

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

Unfunded Mandates: Undetermined

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

CFR Citation: 21 CFR 58.11; 21 CFR 71.1; 21 CFR 101.69; 21 CFR 101.70; 
21 CFR 171.1; 21 CFR 190.6; 21 CFR 312.3; 21 CFR 312.56; 21 CFR 511.1; 
21 CFR 812.46

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            05/00/05

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: None

Agency Contact: Brian L. Pendleton, Regulatory Counsel, Department of 
Health and Human Services, Food and Drug Administration, Suite 3037 
(HFD-7), Center for Drug Evaluation and Research, 5515 Security Lane, 
Suite 1101 (HFD-7), Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562
Email: [email protected]

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




936. HEALTH CLAIMS

Priority: Other Significant

Unfunded Mandates: Undetermined

Legal Authority: 21 USC 343; 21 USC 371

CFR Citation: Not Yet Determined

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

ANPRM                           11/25/03                    68 FR 66040
ANPRM Comment Period Extended   01/27/04                     69 FR 3868
ANPRM Comment Period End        02/25/04
NPRM                            07/00/05

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: None

Federalism:  Undetermined

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

RIN: 0910-AF09
_______________________________________________________________________




937. QUALITY STANDARD REGULATION ESTABLISHING AN 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.

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

[[Page 73137]]

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. On March 25, 2003 (68 FR 14501 at 14503), EPA revised 
the rule text in its January 2001 final rule that established the 10 
parts per billion arsenic drinking water standard to express the 
standard as 0.010 mg/L, in order to clarify the implementation of the 
original rule. 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                            12/02/04                    69 FR 70082
NPRM Comment Period End         01/31/05
Final Rule                      06/00/05

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: Undetermined

Federalism:  Undetermined

Agency Contact: 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
_______________________________________________________________________




938. 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 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                            06/00/05

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), Center for Drug Evaulation and Research, 5515 Security Lane, 
Suite 1101 (HFD-7), Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562

RIN: 0910-AF11
_______________________________________________________________________




939. 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 201.100(b); 21 CFR 201.324

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                            09/00/05

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: None

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

RIN: 0910-AF12
_______________________________________________________________________




940. CHARGING FOR INVESTIGATIONAL DRUGS

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

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

CFR Citation: 21 CFR 312.7; 21 CFR 312.8

Legal Deadline: None

[[Page 73138]]

Abstract: The proposed rule would amend FDA's investigational new drug 
exemption 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                            05/00/05

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected:  Businesses

Government Levels Affected: Undetermined

Agency Contact: Christine F. Rogers, Regulatory Counsel, Department of 
Health and Human Services, Food and Drug Administration, Suite 3059 
(HFD-7), Center for Drug Evaulation and Research, 5515 Security Lane, 
Suite 1101 (HFD-7), Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562

RIN: 0910-AF13
_______________________________________________________________________




941. TREATMENT USE OF INVESTIGATIONAL DRUGS

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

Legal Authority: 21 USC 321; 21 USC 331; 21 USC 351 to 353; 21 USC 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 drugs (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 populations; and 
3) larger populations under a treatment protocol or IND.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            03/00/05

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected:  Businesses

Government Levels Affected: Undetermined

Agency Contact: Christine F. Rogers, Regulatory Counsel, Department of 
Health and Human Services, Food and Drug Administration, Suite 3059 
(HFD-7), Center for Drug Evaulation and Research, 5515 Security Lane, 
Suite 1101 (HFD-7), Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562

RIN: 0910-AF14
_______________________________________________________________________




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

Priority: Substantive, Nonsignificant

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

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

Legal Deadline: None

Abstract: FDA is proposing to amend certain limited provisions of the 
implementing regulations of the Prescription Drug Marketing Act (PDMA) 
of 1987, as modified by the Prescription Drug Amendments (PDA) of 1992 
and the FDA Modernization Act of 1997. Certain provisions of that final 
rule that published on December 3, 1999, (64 FR 67720), do not allow a 
registered blood establishment that provides health care services 
related to its activities as a blood establishment to concurrently 
distribute blood derivatives. The effective date of those provisions of 
that rule is December 1, 2006, as published on February 23, 2004, (69 
FR 8105). FDA is amending the final rule to allow a registered blood 
establishment that concurrently provides health care services to also 
distribute blood derivatives.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/00/05

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

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

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




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

Priority: Info./Admin./Other

Legal Authority: 42 USC 262

CFR Citation: 21 CFR 610.19

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

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

[[Page 73139]]

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

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

RIN: 0910-AF20
_______________________________________________________________________




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

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

Legal Authority: 21 USC 360c

CFR Citation: 21 CFR 884.5300; 21 CFR 884.5310

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/00/04

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected:  Businesses

Government Levels Affected: None

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, HFZ-215, 1350 Piccard 
Drive, Rockville, MD 20850
Phone: 301 827-2974
Fax: 301 594-4765
Email: [email protected]

RIN: 0910-AF21
_______________________________________________________________________




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

Priority: Other Significant

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

CFR Citation: 21 CFR 600; 21 CFR 601; 21 CFR 606; 21 CFR 607; 21 CFR 
610; 21 CFR 630; 21 CFR 640; 21 CFR 660; 21 CFR 820; 21 CFR 1270

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/00/05

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: None

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

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




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

Priority: Routine and Frequent

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

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

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM (Amendment)                12/00/04

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: None

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

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

[[Page 73140]]

_______________________________________________________________________




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

Priority: Routine and Frequent

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

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

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM (Amendment)                12/00/04

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: None

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

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




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

Priority: Routine and Frequent

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

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

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM (Amendment) (Sinusitis 
Claim)                          08/02/04                    69 FR 46119
NPRM (Phenylephrine Bitartrate) 11/02/04                    69 FR 63482
NPRM (Phenyl propanolamine)     12/00/04

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: None

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

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




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

Priority: Routine and Frequent

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

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

Legal Deadline: None

Abstract: The OTC drug review establishes conditions under which OTC 
drugs are considered generally recognized as safe and effective and not 
misbranded. After a final monograph (i.e. final rule) is issued, only 
OTC drugs meeting the conditions of the monograph, or having an 
approved new drug application, may be legally marketed. One action 
addresses labeling intended to better inform consumers of potential 
risks associated with these products. The second action addresses 
products marketed for children under two years old and weight- and age-
based dosing for children's products. The third action addresses 
combination products containing the analgesic acetaminophen or aspirin 
and sodium bicarbonate used as an antacid ingredient.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM (Amendment) (Labeling)     12/00/04
NPRM (Amendment) (Pediatric)    02/00/05
NPRM (Amendment) (Combinations 
with Sodium Bicarbonate)        06/00/05

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: None

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

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




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

Priority: Routine and Frequent

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

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

Legal Deadline: None

[[Page 73141]]

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM (Convenience Sizes)        02/00/05

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: None

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

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




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

Priority: Routine and Frequent

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

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

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM (Phenyl propanolamine)     12/00/04
NPRM (Benzocaine)               06/00/05

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: None

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

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




952.  SUBSTANCES PROHIBITED FROM USE IN ANIMAL FOOD OR 
FEED

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

RIN: 0910-AF46
_______________________________________________________________________




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

Priority: Routine and Frequent

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

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

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM (Amendment)                02/00/05

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: None

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

RIN: 0910-AF49
_______________________________________________________________________




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

Priority: Routine and Frequent

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

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

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM (Amendment)                02/00/05

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Gerald M. Rachanow, Regulatory Counsel, Division of 
Over-the-Counter Drug Products,

[[Page 73142]]

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

RIN: 0910-AF51
_______________________________________________________________________




955.  OVER-THE-COUNTER (OTC) DRUG REVIEW--SKIN 
BLEACHING PRODCUTS

Priority: Routine and Frequent

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

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

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/00/05

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: None

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

RIN: 0910-AF53
_______________________________________________________________________




956.  USE OF MATERIALS DERIVED FROM CATTLE IN HUMAN 
AND ANIMAL MEDICAL PRODUCTS

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

RIN: 0910-AF54
_______________________________________________________________________




957.  REQUIREMENTS FOR HUMAN AND ANIMAL MEDICAL 
PRODUCTS MANUFACTURED FROM, PROCESSED WITH, OR OTHERWISE CONTAINING 
MATERIAL FROM CATTLE

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

RIN: 0910-AF55
_______________________________________________________________________


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


Food and Drug Administration (FDA)



_______________________________________________________________________




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

Priority: Routine and Frequent

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

CFR Citation: 21 CFR 312.110

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

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

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
_______________________________________________________________________




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

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

RIN: 0910-AA94

[[Page 73143]]

_______________________________________________________________________




960. 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
_______________________________________________________________________




961. CURRENT GOOD TISSUE PRACTICE FOR HUMAN CELL, TISSUE, AND CELLULAR 
AND TISSUE-BASED PRODUCT ESTABLISHMENTS; INSPECTION AND ENFORCEMENT

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

RIN: 0910-AB28
_______________________________________________________________________




962. 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                            07/20/04                    69 FR 43357
Final Action                    11/00/05

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, 5515 Security Lane, 
Suite 1101 (HFD-7), Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562
Email: [email protected]

RIN: 0910-AB34
_______________________________________________________________________




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

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

RIN: 0910-AB76
_______________________________________________________________________




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

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

RIN: 0910-AB88
_______________________________________________________________________




965. 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: Final, Statutory, April 17, 2001.

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Rule                    04/24/01                    66 FR 20589
Final Action                    05/00/05

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Carol Drew, Regulatory Counsel, Department of Health 
and Human Services, Food and Drug Administration, Suite 3037 (HFD-7), 
Center for Drug Evaluation and Research, 5515 Security Lane, Suite 1101 
(HFD-7), Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562

RIN: 0910-AC07
_______________________________________________________________________




966. PREVENTION OF SALMONELLA ENTERITIDIS IN SHELL EGGS

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

RIN: 0910-AC14
_______________________________________________________________________




967.  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 final rule would require institutional review boards 
(IRB) to register with FDA. The registration information would include 
the name of the IRB, the name of the institution operating the IRB, and 
names, addresses, phone numbers, facsimile (fax) numbers, and 
electronic mail (e-mail) addresses of the senior officer of the 
institution and IRB chair or contact, the range of active protocols 
(small, medium, or large) involving FDA-regulated products reviewed in 
the previous calendar year, and a description of the types of FDA-
regulated products reviewed. The final rule would make it easier for 
FDA to

[[Page 73144]]

inspect IRBs and to convey information to IRBs.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            07/06/04                    69 FR 40556
Final Action                    04/00/05

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
_______________________________________________________________________




968. 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 Action                    03/00/05

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, HFZ-215, 1350 Piccard 
Drive, Rockville, MD 20850
Phone: 301 827-2974
Fax: 301 594-4765
Email: [email protected]

RIN: 0910-AC32
_______________________________________________________________________




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

Priority: Economically Significant. Major under 5 USC 801.

Legal Authority: 21 USC 351; 21 USC 352; 21 USC 360e to 360j; 21 USC 
360hh to 360ss; 21 USC 371; 21 USC 381

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

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, 1020.32, 
and 1020.33 to address the changes in technology and practice.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

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

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

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, HFZ-215, 1350 Piccard 
Drive, Rockville, MD 20850
Phone: 301 827-2974
Fax: 301 594-4765
Email: [email protected]

RIN: 0910-AC34
_______________________________________________________________________




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

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

RIN: 0910-AC35
_______________________________________________________________________




971. 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. 54 in part II of this issue of 
the Federal Register.

RIN: 0910-AC39
_______________________________________________________________________




972. REGISTRATION OF FOOD AND ANIMAL FEED FACILITIES

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

RIN: 0910-AC40
_______________________________________________________________________




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

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

RIN: 0910-AC41
_______________________________________________________________________




974. 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

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

CFR Citation: 21 CFR 312.120

Legal Deadline: None

Abstract: This final rule follows a proposed rule, which proposed to 
update the standards for the acceptance of foreign clinical studies not 
conducted under an investigational new drug application (IND) as 
support for an IND or marketing application for

[[Page 73145]]

a drug or biological product. We proposed to replace the requirement in 
21 CFR 312.120 that non-IND foreign clinical studies be conducted in 
accordance with ethical principles stated in the Declaration of 
Helsinki or with the laws and regulations of the country that is the 
research site, whichever provide greater protection to subjects. We 
would replace that with a requirement that such studies be conducted in 
accordance with good clinical practice (GCP), including review and 
approval by an independent ethics committee. The proposed GCP standard 
is consistent with the standard of the International Conference on 
Harmonisation of Technical Requirements for Registration of 
Pharmaceuticals for Human Use for GCP and is sufficiently flexible to 
accommodate differences in how countries regulate the conduct of 
clinical research and obtain the informed consent of patients.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/10/04                    69 FR 32467
Final Action                    06/00/05

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, 5515 Security Lane, 
Suite 1101 (HFD-7), Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562
Email: [email protected]

RIN: 0910-AF15
_______________________________________________________________________




975. USE OF OZONE-DEPLETING SUBSTANCES: REMOVAL OF ESSENTIAL USE 
DESIGNATION; ALBUTEROL

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

RIN: 0910-AF18
_______________________________________________________________________




976. BLOOD INITIATIVE--REVISIONS TO LABELING AND STORAGE REQUIREMENTS 
FOR BLOOD AND BLOOD COMPONENTS, INCLUDING SOURCE PLASMA

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

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

CFR Citation: 21 CFR 600; 21 CFR 606; 21 CFR 640

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            07/30/03                    68 FR 44678
NPRM Comment Period End         10/28/03
Final Action                    06/00/05

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: None

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

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




977. CURRENT GOOD MANUFACTURING PRACTICES; QUALITY CONTROL PROCEDURES; 
NOTIFICATION REQUIREMENTS; RECORDS AND REPORTS

Priority: Other Significant

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

CFR Citation: 21 CFR 106; 21 CFR 107

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Action                    09/00/05

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Melissa Scales, Regulatory Counsel, Department of 
Health and Human Services, Food and Drug Administration, HFS-800, HFS-
024, Center for Food Safety and Applied Nutrition, 5100 Paint Branch 
Parkway, College Park, MD 20740
Phone: 301 436-1720
Email: [email protected]

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




978. INFANT FORMULA QUALITY FACTORS

Priority: Other Significant

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

CFR Citation: 21 CFR 106; 21 CFR 107

Legal Deadline: None

Abstract: The agency published a proposed rule on July 9, 1996, that 
would establish current good manufacturing practice regulations, 
quality control procedures, quality

[[Page 73146]]

factors, notification requirements, and records and reports for the 
production of infant formula. This proposal was issued in response to 
the 1986 Amendments to the Infant Formula Act of 1980. On April 28, 
2003, FDA reopened the comment period to update comments on the 
proposal. The comment period was extended on June 27, 2003, to end on 
August 26, 2003.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Action                    09/00/05

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Melissa Scales, Regulatory Counsel, Department of 
Health and Human Services, Food and Drug Administration, HFS-800, HFS-
024, Center for Food Safety and Applied Nutrition, 5100 Paint Branch 
Parkway, College Park, MD 20740
Phone: 301 436-1720
Email: [email protected]

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




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

Priority: Routine and Frequent

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

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

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Action (Amendment) (Common 
Cold)                           04/00/05

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: None

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

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




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

Priority: Routine and Frequent

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

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

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Action (Emergency First 
Aid Eyewashes)                  06/00/05

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: None

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

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




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

Priority: Routine and Frequent

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

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

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Action (Technical 
Amendments)                     01/00/05

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: None

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

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




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

Priority: Routine and Frequent

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

[[Page 73147]]

21 USC 371a; 21 USC 331; 21 USC 358; 21 USC 360; 21 USC 360gg to 360ss; 
21 USC 371; 21 USC 374; 21 USC 379e; 42 USC 216; 42 USC 241; 42 USC 
262; 42 USC 264

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

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Action (Warnings)         04/00/05

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: None

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

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




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

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

RIN: 0910-AF47
_______________________________________________________________________




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

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

RIN: 0910-AF48
_______________________________________________________________________




985.  OVER-THE-COUNTER (OTC) DRUG REVIEW--ANTACID 
PRODUCTS (SODIUM BICARBONATE LABELING)

Priority: Routine and Frequent

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

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

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Action                    06/00/05

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: None

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

RIN: 0910-AF52
_______________________________________________________________________


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


Food and Drug Administration (FDA)



_______________________________________________________________________




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 341 to 344; 21 USC 348; 21 
USC 371; 21 USC 372; 21 USC 374; 21 USC 376; 21 USC 381; 21 USC 393; 42 
USC 264

CFR Citation: 21 CFR 59

Legal Deadline: None

Abstract: The final rule would establish requirements for importers and 
other persons who use sampling services and private laboratories in 
connection with imported food. For example, the rule 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 sampling service or a private laboratory in 
connection with imported food. The final rule is intended to help 
insure the integrity and scientific validity of data and results 
submitted to FDA.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            04/29/04                    69 FR 23460
Final Action                     To Be                       Determined

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: Undetermined

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

[[Page 73148]]

Email: [email protected]

RIN: 0910-AB96
_______________________________________________________________________




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

Priority: Other Significant

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

CFR Citation: Not Yet Determined

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            01/00/06

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: Undetermined

Federalism:  Undetermined

Agency Contact: Rebecca Buckner, Consumer Safety Officer, Department of 
Health and Human Services, Food and Drug Administration, HFS-306, 
Center for Food Safety and Applied Nutrition, 5100 Paint Branch 
Parkway, HFS-366, College Park, MD 20740
Phone: 301 436-1486
Fax: 301 436-2632
Email: [email protected]

RIN: 0910-AC21
_______________________________________________________________________




988. REQUIREMENTS FOR SUBMISSION OF IN VIVO BIOEQUIVALENCE DATA

Priority: Substantive, Nonsignificant

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

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

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

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

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Aileen Ciampa, Regulatory Counsel, Department of Health 
and Human Services, Food and Drug Administration, HFD-7, Center for 
Drug Evaluation and Research, 5515 Security Lane, Suite 1101 (HFD-7), 
Rockville, MD 20857
Phone: 301 594-2041
Fax: 301 827-5562

RIN: 0910-AC23
_______________________________________________________________________




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

Priority: Other Significant

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

CFR Citation: 21 CFR 50.23

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/00/05

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

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

RIN: 0910-AC25

[[Page 73149]]

_______________________________________________________________________




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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

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

Regulatory Flexibility Analysis Required: 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]

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




991. 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 343; 21 USC 371

CFR Citation: 21 CFR 101

Legal Deadline: None

Abstract: FDA initially intended to issue a proposed rule to establish 
requirements for labeling foods that contain common food allergens. The 
purpose of this rulemaking was to reduce mortality and morbidity by 
making it easier for persons who have a food allergy to identify when 
packaged foods contain certain allergenic ingredients. Subsequently, on 
August 2, 2004, the President signed into law the Food Allergen 
Labeling and Consumer Protection Act of 2004 (FALCP Act) (Pub. L. 108-
282), which amended sections 201 and 403 of the Federal, Food, Drug and 
Cosmetic Act (FFD&C Act). FDA is now in the process of determining the 
approach it intends to take in light of the new statutory requirements.
The FALCP Act amended section 201 of the FFD&C Act to define a major 
food allergen as: 1) milk, egg, fish (e.g., bass, flounder, cod), 
Crustacean shellfish (e.g., crab, lobster, shrimp), tree nuts (e.g., 
almonds, pecans, walnuts), wheat, peanuts, and soybeans and 2) any 
ingredient that contains a protein derived from these foods. Excluded 
from this definition are: 1) highly refined oils derived from the food 
source of a major food allergen and ingredients derived from such oils 
and 2) a food ingredient that is exempt under the petition or 
notification process specified in the law. The FALCP Act also amended 
section 403 of the FFD&C Act to require that the labels of packaged 
foods use plain English terms to identify the food source of each of 
the major food allergens it contains as an ingredient. This requirement 
is applicable to all ingredients, including flavors, non-certified 
colors, and incidental additives. The law provides a choice between two 
methods for declaring the food sources of any major food allergens 
contained in the ingredients of packaged foods: either within the 
ingredient list or in a separate summary statement immediately 
following or adjacent to the ingredient list.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                             To Be                       Determined

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

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
_______________________________________________________________________




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

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

Unfunded Mandates: Undetermined

Legal Authority: 21 USC 351

CFR Citation: 21 CFR 211.122

Legal Deadline: None

Abstract: The proposed rule would amend the packaging and labeling

[[Page 73150]]

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

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

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected:  Businesses

Government Levels Affected: None

Federalism:  Undetermined

Agency Contact: Howard P. Muller, Office of Regulatory Policy, 
Department of Health and Human Services, Food and Drug Administration, 
Suite 3037 (HFD-7), Center for Drug Evaluation and Research, 5515 
Security Lane, Suite 1101 (HFD-7), Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562
Email: [email protected]

RIN: 0910-AF08
_______________________________________________________________________




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

Priority: Routine and Frequent

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

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

Legal Deadline: None

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

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: None

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

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




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

Priority: Routine and Frequent

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

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

Legal Deadline: None

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

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: None

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

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




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

Priority: Routine and Frequent

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

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

Legal Deadline: None

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

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: None

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

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

[[Page 73151]]

_______________________________________________________________________


Department of Health and Human Services (HHS)         Completed Actions


Food and Drug Administration (FDA)



_______________________________________________________________________




996. PRESUBMISSION CONFERENCES

Priority: Substantive, Nonsignificant

CFR Citation: 21 CFR 514

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    08/18/04                    69 FR 51162

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Gail Schmerfeld
Phone: 301 827-0205

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




997. DEFINITION OF ``SERIOUS ADVERSE HEALTH CONSEQUENCES'' UNDER THE 
PUBLIC HEALTH SECURITY AND BIOTERRORISM PREPAREDNESS AND RESPONSE ACT OF 
2002

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

CFR Citation: 21 CFR 1.3(c)

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn                       10/07/04

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Karen Carson
Phone: 301 436-1664
Fax: 301 436-2632
Email: [email protected]

John E. Kvenberg
Phone: 301 436-2359
Fax: 301 436-2717
Email: [email protected]

RIN: 0910-AF06
_______________________________________________________________________




998. OVER-THE-COUNTER (OTC) DRUG REVIEW--ANTIPERSPIRANT PRODUCTS

Priority: Routine and Frequent

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

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action (Partial Stay)     10/15/04                    69 FR 61148

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Gerald M. Rachanow
Phone: 301 827-2241
Fax: 301 827-2315
Email: [email protected]

Related RIN: Split from 0910-AA01
RIN: 0910-AF30
_______________________________________________________________________




999.  OVER-THE-COUNTER (OTC) DRUG REVIEW--SODIUM 
LABELING FOR OVER-THE COUNTER DRUGS

Priority: Routine and Frequent

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

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

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Action                    11/29/04                    69 FR 69278

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: None

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

RIN: 0910-AF50
_______________________________________________________________________


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


Health Resources and Services Administration (HRSA)



_______________________________________________________________________




1000. 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.

[[Page 73152]]

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/24/98                    63 FR 71255
Second NPRM                     07/00/05

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Mark S. Pincus, Director, Division of Practitioner Data 
Banks, Department of Health and Human Services, Health Resources and 
Services Administration, Suite 300, 7519 Standish Place, Rockville, MD 
20857
Phone: 301 443-2300

RIN: 0906-AA41
_______________________________________________________________________




1001. 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                     11/00/04

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
_______________________________________________________________________




1002. INTESTINES ADDED TO THE DEFINITION OF ORGANS COVERED BY THE RULES 
GOVERNING THE OPERATION OF THE ORGAN PROCUREMENT AND TRANSPLANTATION 
NETWORK (OPTN)

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

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

CFR Citation: 42 CFR 121

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            11/00/04

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

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

RIN: 0906-AA62
_______________________________________________________________________




1003. NATIONAL VACCINE INJURY COMPENSATION PROGRAM; REVISIONS AND 
ADDITIONS TO THE VACCINE INJURY TABLE

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

Legal Authority: 42 USC 300aa-14, sec 2114; PL 103-66, sec 13632(a)

CFR Citation: 42 CFR 100

Legal Deadline: None

Abstract: The Department of Health and Human Services (HHS) is 
proposing to revise and make additions to the Vaccine Injury Table 
(Table). Section 2114(e) (2) of the Public Health Service Act provides 
for the inclusion of additional vaccines in the National Vaccine Injury 
Compensation Program when they are recommended by the Centers for 
Disease Control and Prevention for routine administration to children. 
In compliance with the Omnibus Budget Reconciliation Act of 1993, which 
added a new section 2114(e) (3) to the Act, a vaccine added to the 
Table through Section 2114(e) will be included in the Table, effective 
when an excise tax to provide funds for the payment of compensation 
with respect to such vaccines takes effect. HHS has determined that 
there are no resources required to implement these changes. Section 
2114 (c) permits the Secretary of HHS to modify the Table.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            11/00/04

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Dr. Geoffrey Evans, Medical Director, Division of 
Vaccine Injury Compensation, Department of Health and Human Services, 
Health Resources and Services Administration, 5600 Fishers Lane, Room 
16C-17, Rockville, MD 20857
Phone: 301 443-4198
Fax: 301 443 8196
Email: [email protected]

RIN: 0906-AA66

[[Page 73153]]

_______________________________________________________________________




1004. NATIONAL VACCINE INJURY COMPENSATION PROGRAM: CALCULATION OF 
AVERAGE COST OF A HEALTH INSURANCE POLICY

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

Legal Authority: Not Yet Determined

CFR Citation: 42 CFR 100, sec 100.2

Legal Deadline: None

Abstract: The Department of Health and Human Services (HHS) is 
proposing to revise the current method for calculating the average cost 
of a health insurance policy, which is an amount deducted from the 
award of compensation in certain cases. According to the Final Rule 
published on June 24, 1992, which established the current calculation, 
``lf, over time, the average cost of health insurance, as calculated by 
the method described above, significantly differs from subsequent HIAA 
survey results or other authoritative sources then available, the 
Secretary of HHS will consider appropriate revisions of this rule.`` 57 
FR 28098 (June 24, 1992). When the latest average monthly of an 
individual health insurance policy was calculated based on the current 
methodology, it was significantly different from the Kaiser Family 
Foundation/Health Research and Educational Trust average monthly cost 
of an individual health insurance policy for the same time period. 
Therefore, the Secretary is proposing a new methodology to calculate 
the average cost of a health insurance policy.
Subtitle 2 of title XXI of the Public Health Service Act, as enacted by 
the National Childhood Vaccine Injury Act of 1986, as amended, (the 
Act) governs the National Vaccine Injury Compensation Program (VICP). 
The VICP, administered by the Secretary of Health and Human Services 
(the Secretary) provides that a proceeding for compensation for a 
vaccine-related injury or death shall be initiated by service upon the 
Secretary, and the filing of a petition with the United States Court of 
Federal Claims (the Court). In some cases, the injured individual may 
receive compensation for future lost earnings, less appropriate taxes 
and the ``average cost of a health insurance policy, as determined by 
the Secretary.'' The elements of compensation that may be awarded to a 
successful petitioner are set out in section 2115 of the Public Service 
Act, 42 U.S.C. section 300aa-15. Subsection (a)(3)(B) specifically 
provides for compensation.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            11/00/04

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Thom E. Balbier Jr., Director, Division of Vaccine 
Injury Compensation, Department of Health and Human Services, Health 
Resources and Services Administration, Room 8A-46, Parklawn Building, 
5600 Fishers Lane, Rockville, MD 20857
Phone: 301 443-6593
Fax: 301 443-8196
Email: [email protected]

RIN: 0906-AA68
_______________________________________________________________________




1005.  REVISION TO 42 CFR SUBPART D--PUBLIC HEALTH 
SERVICE (PHS) GRANT APPEALS PROCEDURE

Priority: Other Significant

Legal Authority: 42 USC 216

CFR Citation: 42 CFR 50.402

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/00/04
Interim Final Rule              02/00/05

Regulatory Flexibility Analysis Required: No

Government Levels Affected: Undetermined

Federalism:  Undetermined

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

RIN: 0906-AA69
_______________________________________________________________________




1006.  HEALTHY TOMORROW'S PARTNERSHIP FOR CHILDREN 
(HTPC) PROGRAM

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

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

CFR Citation: 42 CFR 51(a)

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/00/04

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Jose Belardo, Director, Healthy Tomorrow's Partnership 
for Children Program, Department of Health and Human Services, Health 
Resources and Services Administration, 5600 Fishers Lane, Room 18A-55, 
Rockville, MD 20857

[[Page 73154]]

Phone: 301 443-0757
Email: [email protected]

RIN: 0906-AA70
_______________________________________________________________________


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


Health Resources and Services Administration (HRSA)



_______________________________________________________________________




1007. 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                    11/00/04

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
_______________________________________________________________________




1008. SMALLPOX VACCINE INJURY COMPENSATION PROGRAM: ADMINISTRATIVE 
IMPLEMENTATION

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

Legal Authority: PL 108-20, 117 Stat 638

CFR Citation: 42 CFR 102

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              11/00/04

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Paul T. Clark, Director, Smallpox Vaccine Injury 
Compensation Program, Department of Health and Human Services, Health 
Resources and Services Administration, 10th Floor HRSA/OSP, 4350 East 
West Highway, Bethesda, MD 20814
Phone: 888 496-0338
Email: [email protected]

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




1009. REQUIREMENTS ESTABLISHING A LIMITATION ON ADMINISTRATIVE EXPENSES; 
RYAN WHITE CARE ACT TITLE IV GRANTS FOR COORDINATED SERVICES AND ACCESS 
TO RESEARCH

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

Legal Authority: 42 USC 300ff-71

CFR Citation: Not Yet Determined

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            08/12/03                    68 FR 47923
NPRM Comment Period End         09/11/03
Final Action                    11/00/04

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

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

RIN: 0906-AA65

[[Page 73155]]

_______________________________________________________________________


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


Health Resources and Services Administration (HRSA)



_______________________________________________________________________




1010. 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: Mark S. Pincus, Director, Division of Practitioner Data 
Banks, Department of Health and Human Services, Health Resources and 
Services Administration, Suite 300, 7519 Standish Place, Rockville, MD 
20857
Phone: 301 443-2300

RIN: 0906-AA57
_______________________________________________________________________




1011. OPERATION OF THE ORGAN PROCUREMENT AND TRANSPLANTATION NETWORK 
(OPTN)

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

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

CFR Citation: 42 CFR 121

Legal Deadline: None

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

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

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

RIN: 0906-AA63
_______________________________________________________________________


Department of Health and Human Services (HHS)         Completed Actions


Health Resources and Services Administration (HRSA)



_______________________________________________________________________




1012. LIABILITY PROTECTION FOR CERTAIN FREE CLINIC HEALTH PROFESSIONALS

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

CFR Citation: Not Yet Determined

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn                       09/29/04

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Felicia Collins
Phone: 301 594-0818
Fax: 301 594 5224

RIN: 0906-AA67
_______________________________________________________________________


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


National Institutes of Health (NIH)



_______________________________________________________________________




1013. 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

[[Page 73156]]

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                            04/00/05

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
_______________________________________________________________________




1014. 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.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            04/00/05

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
_______________________________________________________________________




1015. 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.

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            01/00/05

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
_______________________________________________________________________




1016. 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                            02/00/05

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
_______________________________________________________________________




1017. 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                            03/00/05

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

[[Page 73157]]

_______________________________________________________________________




1018. 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                            04/00/05

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
_______________________________________________________________________




1019. 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

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                            04/00/05

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
_______________________________________________________________________




1020. 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                            04/00/05

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
_______________________________________________________________________




1021. 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                            01/00/05

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

[[Page 73158]]

_______________________________________________________________________


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


National Institutes of Health (NIH)



_______________________________________________________________________




1022. 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 Action                    04/00/05

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
_______________________________________________________________________


Department of Health and Human Services (HHS)         Completed Actions


National Institutes of Health (NIH)



_______________________________________________________________________




1023. NATIONAL INSTITUTES OF HEALTH CENTER GRANTS

Priority: Substantive, Nonsignificant

CFR Citation: 42 CFR 52a

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    12/15/03                     68 FR 6961

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Governmental Jurisdictions

Government Levels Affected: None

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

RIN: 0925-AA24
_______________________________________________________________________


Department of Health and Human Services (HHS)             Prerule Stage


Office of Public Health and Science (OPHS)



_______________________________________________________________________




1024. HUMAN SUBJECTS PROTECTION REGULATIONS: ADDITIONAL PROTECTIONS FOR 
ADULT INDIVIDUALS WITH IMPAIRED DECISIONMAKING CAPACITY

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

Legal Authority: 5 USC 301; 42 USC 289

CFR Citation: 45 CFR 46

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

ANPRM                           03/00/05
ANPRM Comment Period End        09/00/05

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Julie A. Kaneshiro, Policy Team Leader, Office for 
Human Research Protections, Department of Health and Human Services, 
Office of Public Health and Science, 1101 Wootton Parkway, Suite 200, 
Rockville, MD 20852
Phone: 301 496-7005
Fax: 301 402-2071
Email: [email protected]

RIN: 0940-AA11

[[Page 73159]]

_______________________________________________________________________


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


Office of Public Health and Science (OPHS)



_______________________________________________________________________




1025. 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                    02/00/05

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

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




1026. 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                            04/16/04                    69 FR 20778
NPRM Comment Period End         06/15/04
Final Action                    05/00/05

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

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




1027. HUMAN SUBJECTS PROTECTION REGULATIONS: INSTITUTIONAL REVIEW BOARDS 
REGISTRATION REQUIREMENTS

Priority: Substantive, Nonsignificant

Legal Authority: 5 USC 301; 42 USC 289

CFR Citation: 45 CFR 46

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            07/04/04                    69 FR 40584
NPRM Comment Period End         10/04/04
Final Action                    04/00/05

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

[[Page 73160]]

Science, Suite 200, The Tower Building, 1101 Wootten Parkway, 
Rockville, MD 20852
Phone: 301 496-7005
Fax: 301 402-0527

RIN: 0940-AA06
_______________________________________________________________________




1028. FEDERAL POLICY FOR THE PROTECTION OF HUMAN SUBJECTS TECHNICAL 
AMENDMENT

Priority: Substantive, Nonsignificant

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

CFR Citation: 45 CFR 46

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Action                    12/00/04

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, Suite 200, 1101 Wootten Parkway, Rockville, MD 20852
Phone: 301 496-7005
Fax: 301 402-0527

RIN: 0940-AA10
_______________________________________________________________________


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


Office of Public Health and Science (OPHS)



_______________________________________________________________________




1029. HUMAN SUBJECTS PROTECTION REGS.: TRAINING AND EDUCATION 
REQUIREMENTS FOR INSTITUTIONAL OFFICIALS, INSTITUTIONAL REVIEW BOARD 
MEMBERS AND STAFF, HUMAN PROTECTIONS ADMINISTRATORS, AND INVESTIGATORS

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

Legal Authority: 5 USC 301; 42 USC 289

CFR Citation: 45 CFR 46

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                             To Be                       Determined

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, Suite 200, 1101 Wootten Parkway, Rockville, MD 20852
Phone: 301 496-7005
Fax: 301 402-0527

RIN: 0940-AA08
_______________________________________________________________________


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


Centers for Medicare & Medicaid Services (CMS)



_______________________________________________________________________




1030. HOME HEALTH AGENCY (HHA) CONDITIONS OF PARTICIPATION (COPS) (CMS-
3819-P)

Priority: Other Significant

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

CFR Citation: 42 CFR 484

Legal Deadline: None

Abstract: This proposed rule would revise the existing 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
Second NPRM                     05/00/05

Regulatory Flexibility Analysis Required: No

[[Page 73161]]

Small Entities Affected: Businesses, Organizations

Government Levels Affected: None

Agency Contact: Mercedes Benitez-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
_______________________________________________________________________




1031. END STAGE RENAL DISEASE (ESRD) CONDITIONS FOR COVERAGE (CMS-3818-
P) (SECTION 610 REVIEW)

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

RIN: 0938-AG82
_______________________________________________________________________




1032. 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. 61 in part II of this issue of 
the Federal Register.

RIN: 0938-AH17
_______________________________________________________________________




1033. HOSPICE CARE--CONDITIONS OF PARTICIPATION (CMS-3844-P)

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

RIN: 0938-AH27
_______________________________________________________________________




1034. STANDARD UNIQUE NATIONAL HEALTH PLAN IDENTIFIERS (CMS-6017-P)

Priority: Other Significant. Major under 5 USC 801.

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

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

CFR Citation: 45 CFR 160; 45 CFR 162

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

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            04/00/05

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: State

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

Agency Contact: 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
_______________________________________________________________________




1035. APPEALS OF CARRIER DETERMINATION THAT A SUPPLIER FAILS TO MEET THE 
REQUIREMENTS FOR MEDICARE BILLING PRIVILEGES (CMS-6003-P2)

Priority: Substantive, Nonsignificant

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

CFR Citation: 42 CFR 405.874

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            10/25/99                    64 FR 57431
Second NPRM                     02/00/05

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
_______________________________________________________________________




1036. RURAL HEALTH CLINICS: AMENDMENTS TO PARTICIPATION REQUIREMENTS AND 
PAYMENT PROVISIONS AND ESTABLISHMENT OF A QUALITY ASSESSMENT AND 
IMPROVEMENT PROGRAM (CMS-1910-P2)

Priority: Other Significant

Legal Authority: 42 USC 1302; 42 USC 1395hh

CFR Citation: 42 CFR 405; 42 CFR 491

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/24/03                    68 FR 74792
Second NPRM                     02/00/05

Regulatory Flexibility Analysis Required: No

[[Page 73162]]

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
_______________________________________________________________________




1037. 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                            01/00/05

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Ralph Goldberg, 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: 410 786-4870

RIN: 0938-AJ98
_______________________________________________________________________




1038. STANDARDS FOR ELECTRONIC HEALTH CARE CLAIM ATTACHMENTS(CMS-0050-P)

Priority: Economically Significant. Major under 5 USC 801.

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

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

CFR Citation: 45 CFR 162

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

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 the data contained in the claims 
standard, to help establish medical necessity for coverage and payment.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            01/00/05

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: Federal, Local, State, Tribal

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

Agency Contact: Lorraine Doo, Health Insurance Specialist, Department 
of Health and Human Services, Centers for Medicare & Medicaid Services, 
Office of Health Insurance Portability and Accountability Act 
Standards, S2-25-17, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-6597

RIN: 0938-AK62
_______________________________________________________________________




1039. ORGAN PROCUREMENT ORGANIZATION CONDITIONS FOR COVERAGE (CMS-3064-
P)

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

RIN: 0938-AK81
_______________________________________________________________________




1040. 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. 64 in part II of this issue of 
the Federal Register.

RIN: 0938-AL26
_______________________________________________________________________




1041. REVISIONS TO CONDITIONS FOR COVERAGE FOR AMBULATORY SURGICAL 
CENTERS (CMS-3887-P)

Priority: Other Significant. Major under 5 USC 801.

Unfunded Mandates: Undetermined

Legal Authority: Not Yet Determined

CFR Citation: None

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/00/05

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 73163]]

_______________________________________________________________________




1042. 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 300gg; PL 104-191

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

Legal Deadline: None

Abstract: This 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. It would also 
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                            11/00/04

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses, Organizations

Government Levels Affected: Federal, Local, State

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

Agency Contact: David Mlawsky, Health Insurance Specialist, Department 
of Health and Human Services, Centers for Medicare & Medicaid Services, 
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
_______________________________________________________________________




1043. MODIFICATIONS TO ELECTRONIC TRANSACTIONS AND CODE SETS (CMS-0009-
P)

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

Unfunded Mandates: Undetermined

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

CFR Citation: 42 CFR 162.1002; 42 CFR 162.1802

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/00/05

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected:  Businesses, Governmental Jurisdictions, 
Organizations

Government Levels Affected: Federal, Local, State, Tribal

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

Agency Contact: Gladys C. Wheeler, Health Insurance Specialist, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-0273

RIN: 0938-AM50
_______________________________________________________________________




1044. 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 would establish requirements for hospice 
services that long term care (LTC) facilities must meet to participate 
in the Medicare and Medicaid programs. We are proposing this new 
requirement to ensure that quality hospice care is provided to eligible 
residents. This proposed rule is intended to assist in meeting the 
Administration's goals for broad-based improvements in the quality of 
health care furnished through the Medicare and Medicaid programs.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/00/05

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: Undetermined

Federalism:  Undetermined

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

RIN: 0938-AM87
_______________________________________________________________________




1045. HOSPITAL CONDITIONS OF PARTICIPATION: REQUIREMENTS FOR HISTORY AND 
PHYSICAL EXAMINATIONS; AUTHENTICATION OF VERBAL ORDERS; SECURING 
MEDICATIONS; AND POST-ANESTHESIA EVALUATIONS (CMS-3122-P)

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

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

CFR Citation: 42 CFR 482

Legal Deadline: None

Abstract: This proposed rule would revise four of the conditions of 
participation that hospitals must meet to participate in the Medicare 
and Medicaid programs to decrease the burden on hospitals and allow 
hospitals to conform to current standards of practice. They must 
establish and maintain policies and procedures that ensure that the 
hospital meets these requirements by using standard practices related 
to history and physical examinations, verbal orders securing of 
medications, and completion of the post-anesthesia evaluation.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            02/00/05

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Organizations

Government Levels Affected: None

Additional Information: Decreases burden for hospitals and clinicaians.

Agency Contact: Patricia Chmielewski, Health Insurance Specialist,

[[Page 73164]]

Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-6899
Email: [email protected]

RIN: 0938-AM88
_______________________________________________________________________




1046. PHYSICIAN REFERRAL FOR NUCLEAR MEDICINE SERVICES AND SUPPLIES 
(CMS-1261-P)

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

Unfunded Mandates: Undetermined

Legal Authority: Sec 1877 of the Social Security Act

CFR Citation: 42 CFR 411.351

Legal Deadline: None

Abstract: This proposed rule would amend the definitions of ``radiology 
and certain other imaging services'' and ``radiation therapy services 
and supplies'' to include diagnostic and therapeutic nuclear medicine 
services and supplies, respectively.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/00/05

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Joanne Sinsheimer, Center for Medicare Management, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, 7500 Security Boulevard, C4-25-02, Baltimore, MD 
21244
Phone: 410 786-4620
Email: [email protected]

RIN: 0938-AN04
_______________________________________________________________________




1047. ENHANCED DSH TREATMENT FOR CERTAIN HOSPITALS (CMS-2198-P)

Priority: Other Significant

Unfunded Mandates: Undetermined

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

CFR Citation: Not Yet Determined

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            02/00/05

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: State

Agency Contact: James Frizzera, Director, National Institutional 
Payment Policy Center for Medicaid and State Operations, Department of 
Health and Human Services, Centers for Medicare & Medicaid Services, 
7500 Security Boulevard, S3-13-15, Baltimore, MD 21244
Phone: 410 786-3263
Email: [email protected]

RIN: 0938-AN09
_______________________________________________________________________




1048. PRIOR DETERMINATION PROCESS FOR CERTAIN ITEMS AND SERVICES (CMS-
6024-P)

Priority: Other Significant. Major under 5 USC 801.

Unfunded Mandates: Undetermined

Legal Authority: Sec 938 of the Medicare Prescription Drug, 
Improvement, and Modernization Act of 2003

CFR Citation: Not Yet Determined

Legal Deadline: Final, Statutory, June 8, 2005.

Abstract: Section 938 of the Medicare Prescription Drug, Improvement, 
and Modernization Act requires that physicians and beneficiaries be 
able to receive a prior determination regarding coverage of certain 
items and physicians' services beginning June 8, 2005. (The final rule 
must be published by March 25, 2005.)

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            03/00/05

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

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

RIN: 0938-AN10
_______________________________________________________________________




1049. COMPETITIVE ACQUISITION FOR CERTAIN DURABLE MEDICAL EQUIPMENT 
(DME), PROSTHETICS, ORTHOTICS, AND SUPPLIES (CMS-1270-P)

Priority: Economically Significant. Major under 5 USC 801.

Legal Authority: PL 108-173, MMA

CFR Citation: 42 CFR 414.200; 42 CFR 405.502(g); 42 CFR 424.57; 42 CFR 
410.38

Legal Deadline: NPRM, Statutory, April 1, 2005.
Final, Statutory, May 1, 2006.

Abstract: Section 302 of the Medicare Modernization Act establishes DME 
competitive bidding. National competitive bidding will provide a 
program for using market forces to set Medicare payment amounts. This 
will also create incentives for suppliers to provide quality items and 
services while at the same time providing Medicare with reasonable 
prices for payment. (The statute requires competitive bidding be 
implemented by January 1, 2007. Proposed and final rules must be 
published six months prior to implementation.)

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/00/05

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses, Governmental Jurisdictions, 
Organizations

Government Levels Affected: Federal, State

Agency Contact: Michael Keane, Health Policy Analyst, Department of 
Health and Human Services, Centers for Medicare & Medicaid Services, 
Center for Medicare Management, 7500 Security Boulevard, C5-08-27, 
Baltimore, MD 21244
Phone: 410 786-4495

[[Page 73165]]

Email: [email protected]

RIN: 0938-AN14
_______________________________________________________________________




1050. UPDATE OF THE LIST OF COVERED PROCEDURES FOR AMBULATORY SURGICAL 
CENTERS FOR 2005 (CMS-1478-PN)

Priority: Other Significant

Legal Authority: Not Yet Determined

CFR Citation: None

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

Abstract: This proposed notice updates the list of Medicare-covered ASC 
procedures. (The subsequent final notice must be published by March 25, 
2005, to be effective July 1, 2005.)

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            11/00/04

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: None

Agency Contact: Bob Cereghino, Health Insurance Specialist, Department 
of Health and Human Services, Centers for Medicare & Medicaid Services, 
Center for Medicare Management, 7500 Security Boulevard, C4-05-17, 
Baltimore, MD 21244
Phone: 410 786-4645
Email: [email protected]

RIN: 0938-AN23
_______________________________________________________________________




1051. REVISIONS TO HIPAA CODE SETS (CMS-0013-P)

Priority: Economically Significant. Major under 5 USC 801.

Unfunded Mandates: Undetermined

Legal Authority: PL 104-191

CFR Citation: 45 CFR 162

Legal Deadline: None

Abstract: This rule proposes revisions to the adopted transaction and 
code set standards detailed in regulations published by HHS on August 
17, 2000, and February 20, 2003. The Secretary intends to propose any 
replacements for specific code sets.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/00/05

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses, Governmental Jurisdictions, 
Organizations

Government Levels Affected: Federal, Local, State, Tribal

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

Energy Effects:  Statement of Energy Effects planned as required by 
Executive Order 13211.

Agency Contact: Patricia Peyton, Health Insurance Specialist, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, Office of HIPAA Standards, S2-26-17, 7500 Security 
Boulevard, Baltimore, MD 21244
Phone: 410 786-1812
Email: [email protected]

RIN: 0938-AN25
_______________________________________________________________________




1052. PAYMENT FOR CLINICAL LABORATORY TESTS (CMS-1494-P)

Priority: Substantive, Nonsignificant

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

CFR Citation: Not Yet Determined

Legal Deadline: None

Abstract: The Medicare Modernization Act of 2003 (MMA), Public Law 108-
173, requires codification of the payment basis for determining 
Medicare payments for new clinical laboratory tests under the clinical 
laboratory fee schedule. Also, section 416 of the MMA eliminates the 
application of the clinical laboratory fee schedule for hospital 
outpatient laboratory testing by a hospital with fewer than 50 beds in 
a qualified rural area for cost reporting periods beginning during the 
2-year period beginning on July 1, 2004. Section 1833(h) of the Act 
mandates payment for outpatient clinical laboratory tests under a 
clinical laboratory fee schedule.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            02/00/05

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: None

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

RIN: 0938-AN26
_______________________________________________________________________




1053. PROSPECTIVE PAYMENT SYSTEM FOR LONG TERM CARE HOSPITALS: ANNUAL 
PAYMENT RATE UPDATES AND POLICY CHANGES FOR 2006 (CMS-1483-P)

Priority: Economically Significant. Major under 5 USC 801.

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

CFR Citation: Not Yet Determined

Legal Deadline: None

Abstract: This rule proposes the payment rate update for the 2006 
prospective payment system for Medicare long-term care hospitals. The 
new rates will be based on cost reports from the first LTC PPS rate 
year. The proposed and final rules must be published by April 29, 2005, 
to be effective July 1, 2005.)

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            01/00/05

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Judy Richter, Health Insurance Specialist, CMS/CMM/
HAPG/DAC, Department of Health and Human Services, Centers for Medicare 
& Medicaid Services, 7500 Security Boulevard, C4-07-07, Baltimore, MD 
21244
Phone: 410 786-2590
Email: [email protected]

RIN: 0938-AN28
_______________________________________________________________________




1054. RANDOM PREPAYMENT REVIEW (CMS-6022-P)

Priority: Other Significant. Major under 5 USC 801.

Legal Authority: Sec 934 of the MMA

CFR Citation: Not Yet Determined

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

Abstract: This proposed rule would implement the statutory requirements

[[Page 73166]]

regarding the termination of non-random prepayment review under section 
934 of the Medicare Modernization Act beginning December 8, 2004. This 
proposed rule would provide guidelines for terminating a provider of 
services or supplier from non-random payment review.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            03/00/05

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Federalism:  Undetermined

Agency Contact: Marie Casey, Health Insurance Specialist, CMS/OFM/PIG, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-7861
Email: [email protected]

RIN: 0938-AN31
_______________________________________________________________________




1055.  REPAYMENT PLANS AND LIMITATION ON RECOUPMENT OF 
OVERPAYMENTS (CMS-6025-P)

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

Legal Authority: Section 935 of the MMA

CFR Citation: None

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

Abstract: This proposed rule would implement two provisions of Section 
935 of the Medicare Modernization Act which added a new subsection to 
Section 1893 of the Social Security Act. It would establish criteria 
and procedures for a repayment plan where repaying a Medicare 
overpayment would be a hardship for a provider or supplier absent 
specific exceptions. It also would prohibit recoupment where a provider 
or supplier has appealed an overpayment determination until the 
reconsideration-level appeal is decided.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/00/05

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Lisa A. Vriezen, Director, Division of Medicare 
Overpayment, Financial Services Group, Office of Financial Management, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-1492
Email: [email protected]

RIN: 0938-AN42
_______________________________________________________________________




1056.  PROSPECTIVE PAYMENT SYSTEM FOR INPATIENT 
REHABILITATION FACILITIES FOR FY 2006 (CMS-1290-P)

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

Unfunded Mandates: Undetermined

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

CFR Citation: Not Yet Determined

Legal Deadline: Final, Statutory, August 1, 2004, Rates for PPS.

Abstract: The proposed rule would update rates for the prospective 
payment system for inpatient rehabilitation facilities for FY 2006. 
(The statute requires that this notice be published by August 1, 2005.)

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            04/00/05

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Federalism:  Undetermined

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-AN43
_______________________________________________________________________




1057.  HOME HEALTH PROSPECTIVE PAYMENT SYSTEM RATE 
UPDATE FOR CALENDAR YEAR 2006 (CMS-1301-P)

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

Legal Authority: Sec 1895 of the Social Security Act

CFR Citation: Not Yet Determined

Legal Deadline: None

Abstract: This poposed 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.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            05/00/05

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Federalism:  Undetermined

Agency Contact: Randy Throndset, Health Insurance Specialist, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, Center for Medicare Management, 7500 Security 
Boulevard, C5-09-15, Baltimore, MD 21244
Phone: 410 786-0131

RIN: 0938-AN44
_______________________________________________________________________




1058.  CHANGES TO THE HOSPITAL OUTPATIENT PROSPECTIVE 
PAYMENT SYSTEM AND CALENDAR YEAR 2006 PAYMENT RATES (CMS-1501-P)

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

Legal Authority: BBA; BBRA; BIPA; MMA

CFR Citation: Not Yet Determined

Legal Deadline: None

Abstract: The proposed rule would adjust payments under the Medicare 
hospital outpatient payment system beginning January 1.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            08/00/05

Regulatory Flexibility Analysis Required: Yes

[[Page 73167]]

Small Entities Affected: Businesses

Government Levels Affected: Federal

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

Agency Contact: Dana Buley, Health Insurance Specialist, Department of 
Health and Human Services, Centers for Medicare & Medicaid Services, 
7500 Security Boulevard, Baltmore, MD 21244
Phone: 410 786-4547
Email: [email protected]

RIN: 0938-AN46
_______________________________________________________________________




1059.  REVISED CIVIL MONEY PENALTIES, ASSESSMENTS, 
EXCLUSIONS, AND RELATED APPEALS PROCEDURES (CMS-6019-P)

Priority: Info./Admin./Other

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

CFR Citation: 42 CFR 402.400

Legal Deadline: Final, Statutory, December 8, 2005.

Abstract: Section 949 of the Medicare Modernization Act changed the 
designation of authority to request waiver of a program exclusion under 
the Social Security Act from the State to the Administrator of a 
Federal health care program. This rule will outline a process for 
health care providers to follow if they wish CMS to request a waiver of 
exclusion on their behalf (effective December 8, 2003).

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            04/00/05

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Joel Cohen, Health Insurance Specialist, CMS/OFM/PIG, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-3349
Email: [email protected]

RIN: 0938-AN48
_______________________________________________________________________




1060.  MEDICARE MODERNIZATION ACT; ELECTRONIC 
PRESCRIBING (CMS-0011-P)

Priority: Economically Significant. Major under 5 USC 801.

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

Legal Authority: 42 USC 1395

CFR Citation: Not Yet Determined

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

Abstract: This rule proposes to enable transmission of basic 
prescription data to and from doctors and pharmacies, and to adopt a 
number of the initial standards required for electronic prescribing by 
section 1860(d) of the Medicare Modernization Act. (The proposed and 
subsequent final rule must be published by September 1, 2005, in order 
for the e-prescribing provisions to be in effect in advance of the 
beginning of the part D benefit and e-prescribing pilot projects in 
January 2006.)

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            11/00/04

Regulatory Flexibility Analysis Required: No

Government Levels Affected: Federal, Local, State, Tribal

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

RIN: 0938-AN49
_______________________________________________________________________




1061.  FURNISHING HOSPITALS WITH INFORMATION TO 
COMPUTE THE DISPROPORTIONATE SHARE HOSPITAL FORMULA (CMS-1283-P)

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

Legal Authority: Section 1886 (d)(5)(F) of the Social Security Act; 
MMA, sec 951

CFR Citation: Not Yet Determined

Legal Deadline: NPRM, Statutory, December 8, 2004.
This provision is a requirement of the MMA and is effective one year 
after the date of the enactment of the Act (December 8, 2004).

Abstract: Section 1886(d)(5)(F) of the Social Security Act provides 
additional payments to subsection (d) hospitals that serve a 
disproportionate share of low-income patients. Section 951 of the 
Medicare Modernization Act requires the Secretary to furnish hospitals 
with the data necessary to compute the number of patient days used in 
calculating the disproportionate patient percentage. This provision is 
effective December 8, 2004. We request this new regulation to solicit 
public comments and subsequently implement this required MMA provision.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            03/00/05

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Sherry Amstead, Health Insurance Specialist, CMS/CMM/
HAPG/DAC, Department of Health and Human Services, Centers for Medicare 
& Medicaid Services, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-4342
Email: [email protected]

RIN: 0938-AN52
_______________________________________________________________________




1062.  END STAGE RENAL DISEASE (ESRD) COMPOSITE RATE 
EXCEPTION (CMS-1278-P)

Priority: Substantive, Nonsignificant

Legal Authority: MMA, sec 623; BIPA, sec 422

CFR Citation: Not Yet Determined

Legal Deadline: None

Abstract: This proposed rule will revise and update existing 
regulations to comply with the statutory changes in BIPA and MMA. Most 
changes will result in significant deletions to existing Regulation 
text. This notice is in response to MMA section 623 and BIPA section 
422. The BIPA 2000 statute eliminates all future opportunities for 
renal dialysis facilities to file exception requests to obtain higher 
composite payment rates The MMA statute of 2003 (via changes to

[[Page 73168]]

BIPA 2000) restored composite rate exceptions only for pediatric renal 
dialysis facilities.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/00/05

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Michael E Powell, Health Insurance Specialist, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-4557
Email: [email protected]

RIN: 0938-AN53
_______________________________________________________________________




1063.  CHANGES TO THE HOSPITAL INPATIENT PROSPECTIVE 
PAYMENT SYSTEM AND FY 2006 RATES (CMS-1500-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, 2005.
Final, Statutory, August 1, 2005.

Abstract: This rule revises the Medicare acute hospital inpatient 
prospective payment system for operating and capital-related costs to 
implement changes arising from our continuing experience with these 
systems. It describes 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, 2005. The rule also sets 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 the final rule to be published by August 
1, 2005.)

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            05/00/05

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: Federal

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

RIN: 0938-AN57
_______________________________________________________________________




1064.  MEDICARE PART B COMPETITIVE ACQUISITION OF 
OUTPATIENT DRUGS AND BIOLOGICALS (CMS-1325-P)

Priority: Economically Significant. Major under 5 USC 801.

Unfunded Mandates: Undetermined

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

CFR Citation: 42 CFR 414

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

Abstract: Section 303(d) of the Medicare Modernization Act requires the 
implementation of a competitive bidding program for Medicare part B 
drugs not paid on a cost or prospective payment system basis. Beginning 
January 1, 2006, physicians will be given a choice between purchasing 
these drugs and being paid by Medicare under the average sales price 
(ASP) system, or obtaining these drugs from vendors selected in a 
competitive bidding process. If the physician elects to obtain drugs 
from a competitive vendor, the vendor will bill Medicare for the drug.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            02/00/05

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Edmund Erdvilas Kasaitis, Health Insurance Specialist, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, Center for Medicare Management, 7500 Security 
Boulevard, C4-01-26, Baltimore, MD 21224
Phone: 410 786-0477
Email: [email protected]

RIN: 0938-AN58
_______________________________________________________________________




1065.  REVISIONS TO THE OVERSIGHT AND VALIDATION 
PROGRAM FOR ACCREDITING ORGANIZATIONS APPROVED FOR DEEMING AUTHORITY 
(CMS-2255-P)

 Regulatory Plan: This entry is Seq. No. 65 in part II of this issue of 
the Federal Register.

RIN: 0938-AN62
_______________________________________________________________________




1066.  SPECIAL PAYMENT PROVISIONS AND STANDARDS FOR 
SUPPLIERS OF CUSTOM FABRICATED ORTHOTICS AND PROSTHETICS (CMS-6012-P)

Priority: Economically Significant. Major under 5 USC 801.

Legal Authority: Benefits Improvement Protection Act of 2000 (BIPA 
2000)

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

Legal Deadline: None

Abstract: Under this provision, Medicare will cover prosthetics and 
certain custom-fabricated orthotics only if furnished by a ``qualified 
practitioner'' and fabricated by a ``qualified practitioner'' or 
``qualified supplier.'' The Secretary, in consultation with experts, is 
required to establish and periodically update a list of custom-
fabricated orthotics and prosthetics subject to this rule. (Congress 
required that a final rule be published not later than one year after 
the date that section 427 of the BIPA was enacted.)

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            07/00/05

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: Undetermined

Federalism:  Undetermined

Agency Contact: Theresa Linkowich, Health Insurance Specialist, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, 7500 Security Boulevard, C3-02-16, Baltimore, MD 
21224
Phone: 410 786-9249

[[Page 73169]]

Email: [email protected]

RIN: 0938-AN63
_______________________________________________________________________




1067.  PROSPECTIVE PAYMENT SYSTEM AND CONSOLIDATED 
BILLING FOR SKILLED NURSING FACILITIES--UPDATE FOR FY 2006 (CMS-1282-P)

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

Unfunded Mandates: Undetermined

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

CFR Citation: Not Yet Determined

Legal Deadline: NPRM, Statutory, August 1, 2005, Updates payment rates.

Abstract: This proposed rule updates payment rates used under the SNF 
PPS beginning October 1, 2005.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            04/00/05

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Federalism:  Undetermined

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-AN65
_______________________________________________________________________


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


Centers for Medicare & Medicaid Services (CMS)



_______________________________________________________________________




1068. HOSPITAL CONDITIONS OF PARTICIPATION: LABORATORY SERVICES (CMS-
3014-IFC)

Priority: Substantive, Nonsignificant

Legal Authority: 42 USC 1302; 42 USC 1395hh

CFR Citation: 42 CFR 482.27

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            11/16/00                    65 FR 69416
Interim Final Rule With Comment 06/00/05

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
_______________________________________________________________________




1069. HEALTH COVERAGE PORTABILITY FOR GROUP HEALTH PLANS AND GROUP 
HEALTH INSURANCE ISSUERS (CMS-2151-F)

Priority: Economically 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                    11/00/04

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: Federal, Local, State

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

Agency Contact: David Mlawsky, Health Insurance Specialist, Department 
of Health and Human Services, Centers for Medicare & Medicaid Services, 
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
_______________________________________________________________________




1070. PROSPECTIVE PAYMENT SYSTEM FOR INPATIENT PSYCHIATRIC FACILITIES 
FOR FY 2004 (CMS-1213-F)

Priority: Economically Significant. Major under 5 USC 801.

Legal Authority: PL 106-113; Sec 124 of the BBRA ; Sec 1886 of the 
Social Security Act

CFR Citation: 42 CFR 412, subpart N; 42 CFR 413; 42 CFR 424

Legal Deadline: NPRM, Statutory, October 1, 2002, Public Law 106-113, 
sec 124.

Abstract: This final rule would set forth a prospective payment system 
for Inpatient hospital services furnished by psychiatric hospitals and 
psychiatric units that will be effective January 1, 2005 (to establish 
the new system).

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            11/28/03                    68 FR 66919

[[Page 73170]]

NPRM Comment Period End         02/26/04
Final Action                    12/00/04

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: Federal, Local, State

Agency Contact: Lana Price, Director, Division of Chronic Care 
Management, Chronic Policy Group, Department of Health and Human 
Services, Centers for Medicare & Medicaid Services, C5-05-27, Center 
for Medicare Management, 7500 Security Boulevard, C5-05-27, Baltimore, 
MD 21244
Phone: 410 786-4533
Email: [email protected]

RIN: 0938-AL50
_______________________________________________________________________




1071. REQUEST FOR INFORMATION ON BENEFIT-SPECIFIC WAITING PERIODS (CMS-
2150-NC)

Priority: Other Significant

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

________________________________________________________________________

Notice                          11/00/04

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
_______________________________________________________________________




1072. REVISIONS TO THE MEDICARE APPEALS PROCESS (CMS-4004-FC)

Priority: Other Significant

Legal Authority: Sec 521 of BIPA

CFR Citation: 42 CFR 405

Legal Deadline: NPRM, Statutory, October 1, 2002, Statutory effective 
date October 1, 2002.

Abstract: This final rule with comment period addresses one discrete 
aspect of the November 15, 2002 proposed rule, ``Changes to the 
Medicare Claims Appeal Procedures'' (67 FR 69312). As required by 
section 1869(b)(1)(F) of the Social Security Act, this rule establishes 
expedited determination and reconsideration procedures for 
beneficiaries who are informed by a provider that Medicare coverage of 
their services is about to end. This rule implements section 937 of the 
Medicare Modernization Act which requires a process for correction of 
minor errors and omissions without pursing the appeals process.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            11/15/02                    67 FR 69312
NPRM Comment Period End         01/14/03
Final Action                    10/00/05

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: Undetermined

Agency Contact: Janet Miller, Health Insurance Specialist, Department 
of Health and Human Services, Centers for Medicare & Medicaid Services, 
N2-14-26, S1-06-04, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-1588

RIN: 0938-AL67
_______________________________________________________________________




1073. REVISIONS TO THE APPEALS PROCESS FOR INITIAL CLAIM DETERMINATIONS 
(CMS-4064-IFC)

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

Unfunded Mandates: Undetermined

Legal Authority: Sec 521 of BIPA

CFR Citation: 42 CFR 40S

Legal Deadline: None

Abstract: This interim final rule will revise the Medicare appeals 
process by adding five-tiered (five levels) of review. It will remove 
the distinction between the processing of initial determination and 
appeals under part A and part B required by section 521 of Benefits 
Improvement and Protection Act of 2000 (BIPA).

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              12/00/04

Regulatory Flexibility Analysis Required: No

Government Levels Affected: Federal

Agency Contact: Michele Edmondson-Parrott, Health Insurance Specialist, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, 7500 Security Boulevard, S1-05-06, Baltimore, MD 
21244
Phone: 410 786-6478

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




1074. CONDITIONS FOR COVERAGE OF POWER MOBILITY DEVICES, INCLUDING 
POWERED WHEELCHAIRS AND POWER-OPERATED VEHICLES SCOOTER(CMS-3017-IFC)

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; 42 USC 1302 ; 42 USC 1359 hh

CFR Citation: 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

________________________________________________________________________

Interim Final Rule              12/00/04

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

Karen Daily, Health Insurance Specialist, Department of Health and

[[Page 73171]]

Human Services, Centers for Medicare & Medicaid Services, 7500 Security 
Boulevard, Baltimore, MD 21244
Phone: 410 786-0189
Email: [email protected]

RIN: 0938-AM74
_______________________________________________________________________




1075. CHANGES TO THE HOSPITAL OUTPATIENT PROSPECTIVE SYSTEM AND CALENDAR 
YEAR 2005 PAYMENT RATES (CMS-1427-FC)

Priority: Economically 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: Final, Statutory, January 1, 2005.

Abstract: The rule revises the Medicare hospital outpatient prospective 
payment system beginning January 1, 2005. It also responds to comments 
received from the 2004 Outpatient PPS update (CMS-1371-IFC).

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            08/16/04                    69 FR 50497
Final Action                    11/00/04

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

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

Related RIN: Related to 0938-AM96
RIN: 0938-AM75
_______________________________________________________________________




1076. REVISIONS TO PAYMENT POLICIES UNDER THE PHYSICIAN FEE SCHEDULE FOR 
CALENDAR YEAR 2005 (CMS-1429-FC)

Priority: Economically Significant. Major under 5 USC 801.

Legal Authority: 42 USC 1395W-4

CFR Citation: 42 CFR 410; 42 CFR 414

Legal Deadline: NPRM, Statutory, June 1, 2004, Revisions to Payment 
Policies.
Final, Statutory, January 1, 2005.

Abstract: This final rule with comment period makes several changes 
affecting Medicare part B payment. It also includes several provisions 
on preventive care from the Medicare Modernization Act including, 
initial preventive physical examination, cardiovascular screening blood 
tests, and diabetes screening tests.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            08/05/04                    69 FR 47488
NPRM Comment Period End         09/24/04
Final Action                    11/00/04

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

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

Related RIN: Related to 0938-AM97
RIN: 0938-AM90
_______________________________________________________________________




1077. MEDICARE ADVANTAGE PROGRAM--TITLE II (CMS-4069-F)

 Regulatory Plan: This entry is Seq. No. 66 in part II of this issue of 
the Federal Register.

RIN: 0938-AN06
_______________________________________________________________________




1078. MEDICARE DRUG BENEFIT EFFECTIVE CALENDAR YEAR 2006--TITLE I (CMS-
4068-F)

 Regulatory Plan: This entry is Seq. No. 67 in part II of this issue of 
the Federal Register.

RIN: 0938-AN08
_______________________________________________________________________




1079. SCHEDULE FOR PUBLISHING MEDICARE FINAL REGULATIONS AFTER A 
PROPOSED OR INTERIM FINAL REGULATION (CMS-9026-N)

Priority: Other Significant

Legal Authority: Sec 902 of the Medicare Modernization Act of 2003

CFR Citation: None

Legal Deadline: None

Abstract: In accordance with Section 902 of the Medicare Modernization 
Act of 2003, this rule establishes a regular timeline for the 
publication of final regulations based on the previous publication of a 
proposed or interim final regulation.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Notice                          11/00/04

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Renee Swann, Health Insurance Specialist, Department of 
Health and Human Services, Centers for Medicare & Medicaid Services, 
Office of Strategic Operations and Regulatory Affairs, C5-14-03, 7500 
Security Boulevard, Baltimore, MD 21244
Phone: 410 786-4492
Email: [email protected]

RIN: 0938-AN12
_______________________________________________________________________




1080. EVALUATION CRITERIA AND STANDARDS FOR QUALITY IMPROVEMENT PROGRAM 
CONTRACTS (CMS-3142-NC)

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

Legal Authority: Sec 1153(h)(2) of the Social Security Act

CFR Citation: None

Legal Deadline: Final, Statutory, August 31, 2004.
There is a 60 day comment period required for the evaluation criteria 
used in evaluating the Quality Improvement Organizations.

Abstract: Section 1153(h)(2) of the Act Social Security requires the 
Secretary to publish in the Federal Register the general criteria and 
standards that will be used to evaluate the Quality Improvement 
Organizations (QIOs), and provide opportunity for public comment. This 
notice will describe the evaluation criteria CMS will use to evaluate 
the QIOs. There should be no additional costs associated with this 
requirement. The evaluation portion of the contract has already been 
factored into the award. (This notice with comment period must be 
published by May 28, 2004, to allow sufficient time

[[Page 73172]]

for receipt and response to comments prior to the first round of QIO 
evaluations beginning November 2004. Delaying the first round of 
evaluations will delay the statutory requirement to notify QIOs of 
nonrenewal of their current contracts 90 days prior to their 
expiration, as well as extend the QIOs' work beyond the current 
contract period.)

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Notice With Comment Period      07/23/04                    69 FR 44031
Comment Period End              08/23/04
Final Action                    04/00/05

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Maria L, Hammel, Health Insurance Specialist, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, Office of Clinical Standards and Quality, 7500 
Security Boulevard, S2-01-01, Baltimore, MD 21244
Phone: 410 786-1775
Email: [email protected]

RIN: 0938-AN13
_______________________________________________________________________




1081. MEDICARE SECONDARY PAYER (MSP): WORKMEN'S COMPENSATION (CMS-6272-
IFC)

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

Legal Authority: Sec 301 of the Medicare Prescripition Drug, 
Improvement, and Modernization Act of 2003

CFR Citation: 42 CFR 411

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

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule With Comment 
Period                          06/00/05

Regulatory Flexibility Analysis Required: No

Government Levels Affected: Undetermined

Agency Contact: Suzanne Ripley, Health Insurance Specialist Office of 
Finanical Management, Department of Health and Human Services, Centers 
for Medicare & Medicaid Services, 7500 Security Boulevard, C4-25-02, 
Baltimore, MD 21244
Phone: 410 786-0970
Email: [email protected]

RIN: 0938-AN27
_______________________________________________________________________




1082. FIRE SAFETY REQUIREMENTS FOR CERTAIN HEALTH CARE FACILITIES; 
ALCOHOL-BASED HAND SANITIZER AMENDMENT (CMS-3145-IFC)

Priority: Other Significant

Legal Authority: Not Yet Determined

CFR Citation: None

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule With Comments12/00/04

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Additional Information: Providers requesting publication of this 
regulation.

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

RIN: 0938-AN36
_______________________________________________________________________




1083.  MODIFICATIONS TO MANAGED CARE RULES (CMS-4041-
IFC)

Priority: Other Significant

Legal Authority: 1857(g)(3)(a)

CFR Citation: 42 CFR 422

Legal Deadline: None

Abstract: In the August 22, 2003, issue of the Federal Register, we 
published a final rule titled `` Modifications to Medicare Rules'' (68 
FR 50840). The effective date for that final rule was September 22, 
2003. This interim final rule with comment period corrects a limited 
number of technical and typographical errors identified in the August 
22, 2003, final rule.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              12/00/04

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Tony Hausner, Health Insurance Specialist, Department 
of Health and Human Services, Centers for Medicare & Medicaid Services, 
7500 Security Boulevard, C4-24-02, Baltimore, MD 21244
Phone: 410 786-1093

Related RIN: Related to 0938-AK71
RIN: 0938-AN38
_______________________________________________________________________




1084.  DEVELOPMENT OF NEW STANDARDS FOR MEDIGAP 
POLICIES (CMS-2197-FN)

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

Legal Authority: Section 104 of the MMA

[[Page 73173]]

CFR Citation: None

Legal Deadline: None

Abstract: According to section 104 of the MMA, Medigap issuers must 
send written notice to beneficiaries with Medigap drug coverage during 
the 60-day period immediately preceding the initial Medicare part D 
enrollment period which begins November 15, 2005. Therefore, Medigap 
issuers will have to send the notices from mid-September 2005 to mid-
November 2005. This final notice will set forth the standards for the 
written notice that Medigap issuers must provide to policyholders with 
drug coverage. (The final notice must be published by May 27, 2005, to 
give Medigap issuers sufficient time to send notices).

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Notice                    05/00/05

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Kathryn D. McCann, Health Insurance Specialist, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, Center for Medicaid and State Operations, 7500 
Security Boulevard, S3-16-16, Baltimore, MD 21224
Phone: 410 786-7623
Email: [email protected]

RIN: 0938-AN50
_______________________________________________________________________




1085.  TIME LIMITATION ON RECORDKEEPING REQUIREMENTS 
UNDER THE DRUG REBATE PROGRAM (CMS-2175-F)

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

Legal Authority: 42 USC 1396

CFR Citation: 42 CFR 447.534

Legal Deadline: None

Abstract: This final rule finalizes the 10-year recordkeeping 
requirements. Manufacturers must retain records for 10 years from the 
date the manufacturer reports data to us for a rebate period. This 
final rule also finalizes the requirement that manufacturers must 
retain records beyond the 10-year period if the records are known by 
the manufacturer to be the subject of an audit or a government 
investigation. Furthermore, it responds to public comments on the 
January 6, 2004, interim final rule with comment period and the 
proposed rule pertaining to the 10-year recordkeeping comments, 
respectively.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule With Comments01/06/04                      69 FR 508
Final Action                    11/00/04

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: State

Federalism:  Undetermined

Agency Contact: Kimberly M. Howell, Health Insurance Specialist, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-6762
Email: [email protected]

Larry Reed, Chief, Medicaid Noninstitutional Payment Policy Branch, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, S2-01-16, 7500 Security Boulevard, Baltimore, MD 
21244
Phone: 410 786-3325

Related RIN: Related to 0938-AM20
RIN: 0938-AN55
_______________________________________________________________________




1086.  FISCAL YEAR 2006 SCHIP ALLOTMENTS (CMS-2219-N)

Priority: Economically Significant

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

CFR Citation: 42 CFR 457

Legal Deadline: None

Abstract: This notice sets forth the final allotments of Federal 
funding available to each State, the District of Columbia, and each 
U.S. Territory and Commonwealth for fiscal year 2006. (The notice must 
be published on August 27, 2004, so that the funds can be distributed 
to the States before September 30, 2005, as required by the statute.)

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Notice                          08/00/05

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: State

Agency Contact: Richard Strauss, Director, Division of Financial 
Management, Department of Health and Human Services, Centers for 
Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, MD 
21244
Phone: 410 786-2019
Email: [email protected]

RIN: 0938-AN56
_______________________________________________________________________


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


Centers for Medicare & Medicaid Services (CMS)



_______________________________________________________________________




1087. 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 HHS the authority to enroll 
and reenroll providers with time frames for reenrollment.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

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

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: None

[[Page 73174]]

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
_______________________________________________________________________




1088. 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 Action                    12/00/06

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: Rebecca Donnay, 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: 410 786-1428

RIN: 0938-AJ10
_______________________________________________________________________




1089. MEDICARE HOSPICE CARE AMENDMENTS (CMS-1022-F)

Priority: Substantive, Nonsignificant

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

CFR Citation: 42 CFR 418

Legal Deadline: 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                    11/00/05

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, 
C4-05-27, Centers for Medicare Management, 7500 Security Boulevard, C4-
05-27, Baltimore, MD 21244
Phone: 410 786-4480

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




1090. USE OF RESTRAINT AND SECLUSION IN RESIDENTIAL TREATMENT FACILITIES 
PROVIDING INPATIENT PSYCHIATRIC SERVICES TO INDIVIDUALS UNDER AGE 21 
(CMS-2065-F)

Priority: Other Significant

Legal Authority: 42 USC 1302; 42 USC 1396d

CFR Citation: 42 CFR 441 to 442; 42 CFR 483

Legal Deadline: None

Abstract: This rule addresses standards of practice that residential 
treatment facilities providing inpatient psychiatric services for 
individuals under age 21 must meet with regard to the use of restraints 
(including psychoactive drugs) and seclusion.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              01/22/01                     66 FR 7148
60-Day Delay of Effective Date 
To 05/22/2001                   03/21/01                    66 FR 15800
Interim Final Rule Comment 
Period End                      03/23/01
Interim Final Rule Effective    03/23/01
Interim Final Rule Amendment 
with Clarification              05/22/01                    66 FR 28110
Interim Final Rule Comment 
Period End                      07/23/01
Final Action                    12/00/06

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Larry Cutler, Health Insurance Specialist, Department 
of Health and Human Services, Centers for Medicare & Medicaid Services, 
S2-14-26, Center for Medicaid and State Operations, 7500 Security 
Boulevard, Baltimore, MD 21244
Phone: 410 786-5903

RIN: 0938-AJ96
_______________________________________________________________________




1091. PHYSICIANS' REFERRALS TO HEALTH CARE ENTITIES WITH WHICH THEY HAVE 
FINANCIAL RELATIONSHIPS--PHASE II (CMS-1810-IFC)

Priority: Other Significant

Legal Authority: 42 USC 1877

CFR Citation: 42 CFR 411; 42 CFR 424

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.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              03/26/04                    69 FR 16054
Interim Final Rule Comment 
Period End                      06/24/04
Correction Notice               04/06/04                    69 FR 17933
 Second Correction Notice       09/24/04                    69 FR 57226
Final Action                    06/00/07

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses, Organizations

Government Levels Affected: None

[[Page 73175]]

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
_______________________________________________________________________




1092. PROVIDER REIMBURSEMENT DETERMINATIONS AND APPEALS (CMS-1727-F)

Priority: Substantive, Nonsignificant

Legal Authority: Sec 1878 of the Social Security Act

CFR Citation: 42 CFR 405

Legal Deadline: None

Abstract: This final 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                            06/25/04                    69 FR 35716
NPRM Comment Period End         08/24/04
Final Action                    06/00/07

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Morton Marcus, 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
_______________________________________________________________________




1093. DMERC SERVICE AREAS AND RELATED MATTERS (CMS-1219-F)

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)(1) of the Social Security Act

CFR Citation: 42 CFR 421.210

Legal Deadline: None

Abstract: This rule allows flexibility in making changes to the DMERC 
contractor structure.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            03/26/04                    69 FR 15755
NPRM Comment Period End         05/25/04
Final Action                    03/00/07

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Colette Shatto, Health Insurance Specialist, Department 
of Health and Human Services, Centers for Medicare & Medicaid Services, 
S1-01-26, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-6932

RIN: 0938-AL76
_______________________________________________________________________




1094. 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
Interim Final Rule Comment 
Period End                      10/16/03
Final Action                    08/00/06

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: None

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

RIN: 0938-AM22
_______________________________________________________________________




1095. PROCEDURES FOR MAINTAINING CODE LISTS IN THE NEGOTIATED NATIONAL 
COVERAGE DETERMINATIONS FOR CLINICAL DIAGNOSTIC LABORATORY SERVICES 
(CMS-3119-FN)

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: None

Legal Deadline: None

Abstract: This final rule establishes the procedures to be used for 
maintaining the lists of codes that were included in the national 
coverage determinations (NCDs) announced on November 25, 2001.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/24/03                    68 FR 74607
NPRM Comment Period End         02/23/04
Final Action                    12/00/06

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: None

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
_______________________________________________________________________




1096. REQUIREMENTS FOR LONG TERM CARE FACILITIES; NURSING SERVICES; 
POSTING OF NURSE STAFFING INFORMATION (CMS-3121-F)

Priority: Other Significant

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

CFR Citation: 42 CFR 483

Legal Deadline: None

Abstract: This final rule implements section 941 of the Medicare, 
Medicaid, and SCHIP Benefits Improvement and Protection Act of 2000 and 
requires nursing homes to post daily, for each shift, the number of 
full-time equivalents (FTEs) of registered nurses,

[[Page 73176]]

licensed practical nurses, licensed vocational nurses, and certified 
nurse aides who are directly responsible for resident care.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

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

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Anita Panicker, Department of Health and Human 
Services, Centers for Medicare & Medicaid Services, S3-04-26, Office of 
Clinical Standards and Quality, 7500 Security Boulevard, S3-02-01, 
Baltimore, MD 21244
Phone: 410 786-5646

RIN: 0938-AM55
_______________________________________________________________________




1097. REVISED CIVIL MONEY PENALTIES, ASSESSMENTS, EXCLUSIONS, AND 
RELATED APPEALS PROCEDURES (CMS-6146-F)

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

Unfunded Mandates: Undetermined

Legal Authority: Not Yet Determined

CFR Citation: Not Yet Determined

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            07/23/04                    69 FR 43956
Final Action                    07/00/07

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Agency Contact: Joel Cohen, 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-AM98
_______________________________________________________________________




1098. PAYMENT FOR RESPIRATORY ASSIST DEVICES WITH BI-LEVEL CAPABILITY 
AND A BACK-UP RATE (CMS-1167-F)

Priority: Other Significant

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

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

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

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Action                    08/00/06

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: None

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

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




1099. NONDISCRIMINATION IN POST-HOSPITAL REFERRAL TO HOME HEALTH 
AGENCIES AND OTHER ENTITIES (CMS-1224-F)

Priority: Substantive, Nonsignificant

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

CFR Citation: 42 CFR 482

Legal Deadline: None

Abstract: This final rule establishes a process for collecting and 
maintaining information about hospitals referring Medicare patients to 
home health agencies (HHAs) with which the hospitals have a financial 
interest. Collected information will be available to the public to 
enhance its understanding and awareness of the availability of 
Medicare-certified HHAs to serve the Medicare population. (This final 
rule must be published by November 22, 2005, to meet the three-year 
publication deadline.)

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            11/22/02                    67 FR 70373
Final Action                    11/00/05

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

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

RIN: 0938-AN19
_______________________________________________________________________




1100. MEDICARE AMBULANCE FEE SCHEDULE UPDATE (CMS-1492-F)

Priority: Economically Significant

Legal Authority: Sec 1834(i) of the Social Security Act; Sec 414 of the 
MMA

CFR Citation: 42 CFR 414, subpart H

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

Abstract: Section 414 of the Medicare Modernization Act provides for 
temporary increases to the Medicare ambulance fee schedule beginning 
July 1, 2004. It also increases mileage payments for certain long 
trips.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              07/01/04                    69 FR 40288
Interim Final Rule Comment 
Period End                      08/30/04
Final Action                    07/00/07

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: Local

Agency Contact: Robert Niemann, Health Insurance Specialist,

[[Page 73177]]

CMS/CMM/HAPG/DAS, Department of Health and Human Services, Centers for 
Medicare & Medicaid Services, 7500 Security Boulevard, C4-05-17, 
Baltimore, MD 21244
Phone: 410 786-4596
Email: [email protected]

RIN: 0938-AN24
_______________________________________________________________________




1101. NONDISCRIMINATION IN HEALTH COVERAGE AND WELLNESS PLANS IN THE 
GROUP MARKET (CMS-2022-F)

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

Legal Authority: 42 USC 300gg

CFR Citation: 45 CFR 146.121

Legal Deadline: None

Abstract: This document contains final rules governing the provisions 
prohibiting discrimination based on a health factor for group health 
plans and issuers of health insurance coverage offered in connection 
with a group health plan. The rules contained in this document 
implement changes made to the Internal Revenue Code of 1986 (Code), the 
Employee Retirement Income Security Act of 1974, and the Public Health 
Service Act enacted as part of the Health Insurance Portability and 
Accountability Act of 1966. It also addresses comments we received on 
the Bonafide Wellness Plan proposed rule (CMS-2078-P).

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              04/08/97                    62 FR 16894
Interim Final Rule Comment 
Period End                      07/17/97
Interim Final Rule Effective    07/17/97
Interim Final Rule              01/08/01                     66 FR 1378
Interim Final Rule Effective    03/09/01
Interim Final Rule Comment 
Period End                      04/09/01
Final Action                    12/00/06

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses, Governmental Jurisdictions

Government Levels Affected: Local, State

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

RIN: 0938-AN29
_______________________________________________________________________




1102. HOSPITAL CONDITIONS OF PARTICIPATION: PATIENTS' RIGHTS (CMS-3018-
F)

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

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

CFR Citation: 42 CFR 482

Legal Deadline: None

Abstract: This final rule sets forth standards for the use of 
restraints and seclusion in Medicare- and Medicaid-participating 
hospitals as part of the Patients' Rights Condition of Participation 
(CoP) and finalizes other patients' rights afforded by that CoP. It 
finalizes six standards that ensure minimum protections of each 
patient's physical and emotional health and safety. These standards 
address each patient's right to: notification of his or her rights; the 
exercise of his or her rights in regard to his or her care; privacy and 
safety; confidentiality of patient records; freedom from restraints 
used in the provision of acute medical and surgical care unless 
clinically necessary; and freedom from seclusion and restraint for 
behavior management unless clinically necessary.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

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

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Patricia Chmielewski, 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: 410 786-6899
Email: [email protected]

RIN: 0938-AN30
_______________________________________________________________________




1103. FEDERAL ENFORCEMENT IN GROUP AND INDIVIDUAL HEALTH INSURANCE 
MARKETS (CMS-2019-F)

Priority: Other Significant

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

CFR Citation: 45 CFR 150.101 to 150.465

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

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

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: Local, State

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

RIN: 0938-AN35
_______________________________________________________________________




1104.  GROUP MARKET HEALTH INSURANCE REFORM: 
GUARANTEED AVAILABILITY, GUARANTEED RENEWABILITY, DISCLOSURES TO SMALL 
EMPLOYERS (CMS-2216-F)

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

Legal Authority: 42 USC 300gg-92

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

Legal Deadline: None

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

[[Page 73178]]

health insurance coverage to small and large employers.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Action                    12/00/06

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: David R. Mlawsky, Health Insurance Specialist, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, Center for Medicaid and State Operations, 7500 
Security Boulevard, Baltimore, MD 21244
Phone: 877 267-2323
Email: [email protected]

RIN: 0938-AN60
_______________________________________________________________________




1105.  INDIVIDUAL MARKET HEALTH INSURANCE REFORM: 
PORTABILITY FROM GROUP TO INDIVIDUAL COVERAGE; FEDERAL RULES FOR ACCESS 
IN THE INDIVIDUAL MARKET; STATE ALTERNATIVE MECHANISMS TO FEDERAL RULES 
(CMS-2217-F)

Priority: Other Significant. Major under 5 USC 801.

Legal Authority: 42 USC 300gg-92

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

Legal Deadline: None

Abstract: This regulation finalizes the interim final rule (BPD-890-
IFC) that guarantees availability of health coverage to certain 
individuals, guarantees renewability of coverage in the individual 
market, and sets standards for State alternative mechanisms for 
guaranteeing coverage to certain individuals.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Action                    12/00/06

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

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

RIN: 0938-AN61
_______________________________________________________________________


Department of Health and Human Services (HHS)         Completed Actions


Centers for Medicare & Medicaid Services (CMS)



_______________________________________________________________________




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

Priority: Economically Significant

CFR Citation: 42 CFR 406.12

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    09/24/04                    69 FR 57224

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Denise Cox
Phone: 410 786-3195

RIN: 0938-AK94
_______________________________________________________________________




1107. INTEREST CALCULATION (CMS-6014-F)

Priority: Other Significant

CFR Citation: 42 CFR 405.378; 42 CFR 411.24

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    07/30/04                    69 FR 45604

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses, Organizations

Government Levels Affected: None

Agency Contact: Nancy Braymer
Phone: 410 786-4323

RIN: 0938-AL14
_______________________________________________________________________




1108. HOSPITAL PATIENTS' RIGHTS COP--STANDARD SAFETY COMPLIANCE 
COMMITTEES (CMS-3120-P)

Priority: Economically Significant. Major under 5 USC 801.

CFR Citation: 42 CFR 482

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn                       06/30/04

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses, Organizations

Government Levels Affected: Undetermined

Federalism:  Undetermined

Agency Contact: Rachael Weinstein
Phone: 410 786-6775

RIN: 0938-AM39
_______________________________________________________________________




1109. PROSPECTIVE PAYMENT SYSTEM AND CONSOLIDATED BILLING FOR SKILLED 
NURSING FACILITIES--UPDATE FOR FY 2006 (CMS-1249-N)

Priority: Other Significant. Major under 5 USC 801.

CFR Citation: 42 CFR 413.330 to 413.350

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Notice                          07/30/04                    69 FR 45775

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: William Ullman
Phone: 401 786-5667

RIN: 0938-AM46
_______________________________________________________________________




1110. TITLE I: NON-FEDERAL GOVERNMENTAL PLANS EXEMPT FROM HIPAA (CMS-
2033-F)

Priority: Substantive, Nonsignificant

CFR Citation: 45 CFR 146.180

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    07/23/04                    69 FR 43926

[[Page 73179]]

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: Local, State

Agency Contact: Dave Holstein
Phone: 410 786-1564

Related RIN: Related to 0938-AK00
RIN: 0938-AM71
_______________________________________________________________________




1111. HOSPICE WAGE INDEX FY 2005 (CMS-1264-N)

Priority: Routine and Frequent

CFR Citation: None

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Notice                          08/27/04                    69 FR 52710

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Terri Deutseh
Phone: 410 786-9462
Email: [email protected]

RIN: 0938-AM78
_______________________________________________________________________




1112. TICKET TO WORK: DEFINING INDIVIDUALS WITH POTENTIALLY SEVERE 
DISABILITIES AND PROVIDING A WORK THRESHOLD (CMS-2172-P)

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

CFR Citation: None

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn                       06/30/04

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Carey Appold
Phone: 410 786-2117

RIN: 0938-AM79
_______________________________________________________________________




1113. CHANGES TO THE HOSPITAL INPATIENT PROSPECTIVE PAYMENT SYSTEM AND 
FY 2005 RATES (CMS-1428-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                            05/18/04                    69 FR 28195
Correction Notice               06/25/04                    69 FR 35920
Final Action                    08/11/04                    69 FR 48916

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: Federal

Agency Contact: Tzvi Hefter
Phone: 410 786-4487

RIN: 0938-AM80
_______________________________________________________________________




1114. COVERED OUTPATIENT DRUGS UNDER THE MEDICAID DRUG REBATE PROGRAM 
(CMS-2174-P)

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

CFR Citation: 42 CFR 441 ; 42 CFR 447

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn                       08/10/04

Regulatory Flexibility Analysis Required: No

Government Levels Affected: Undetermined

Federalism:  Undetermined

Agency Contact: Marge Watchorn
Phone: 410 786-4361

RIN: 0938-AM81
_______________________________________________________________________




1115. PROSPECTIVE PAYMENT SYSTEM FOR INPATIENT REHABILITATION FACILITIES 
FOR FY 2005 (CMS-1360-N)

Priority: Substantive, Nonsignificant

CFR Citation: None

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Notice                          07/30/04                    69 FR 45721

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Robert Kuhl
Phone: 410 786-4597

RIN: 0938-AM82
_______________________________________________________________________




1116. PAYMENT ERROR RATE MEASUREMENT (PERM) PROGRAM (CMS-6026-P)

Priority: Other Significant. Major under 5 USC 801.

CFR Citation: None

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn                       05/28/04

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: State

Agency Contact: Christine Saxonis
Phone: 410 786-3722
Email: [email protected]

RIN: 0938-AM86
_______________________________________________________________________




1117. HOME HEALTH PROSPECTIVE PAYMENT SYSTEM RATE UPDATE FY 2005 (CMS-
1265-F)

Priority: Economically Significant. Major under 5 USC 801.

CFR Citation: 42 CFR 484

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/02/04                    69 FR 31248
Correction Notice               07/03/04                    69 FR 45775
Final Action                    10/22/04                    69 FR 62124

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Randy Throndset
Phone: 410 786-0131

RIN: 0938-AM93
_______________________________________________________________________




1118. REVISIONS TO COST SHARING REGULATIONS (CMS-2144-P)

Priority: Other Significant

CFR Citation: 42 CFR 447.51 to 447.56

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn                       08/16/04

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: Federal, State

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

[[Page 73180]]

Agency Contact: Alissa Deboy
Phone: 410 786-6041

RIN: 0938-AM94
_______________________________________________________________________




1119. MEDICARE PROGRAM; HOSPITAL OUTPATIENT PROSPECTIVE PAYMENT SYSTEM 
PAYMENT REFORM FOR CALENDAR YEAR 2004 CMS-1371-F

Priority: Other Significant. Major under 5 USC 801.

CFR Citation: Not Yet Determined

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Merged With 0938-AM75           11/15/04

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Agency Contact: Dana Buley
Phone: 410 786-4547
Email: [email protected]

RIN: 0938-AM96
_______________________________________________________________________




1120. CHANGES TO MEDICARE PAYMENT FOR DRUGS AND PHYSICIAN FEE SCHEDULE 
PAYMENTS FOR CALENDAR YEAR 2004--CORRECTION NOTICE CMS-1372-F)

Priority: Economically Significant. Major under 5 USC 801.

CFR Citation: 42 CFR 405; 42 CFR 414

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Correction                      06/25/04                    69 FR 35527
Merged With 0938-AM90           11/15/04

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: Federal

Agency Contact: Marc Hartstein
Phone: 410 786-4539
Email: [email protected]

RIN: 0938-AM97
_______________________________________________________________________




1121. PHYSICIANS' REFERRALS TO HEALTH CARE ENTITIES WITH WHICH THEY HAVE 
FINANCIAL RELATIONSHIPS: EXTENSION OF PARTIAL DELAY OF EFFECTIVE DATE 
(CMS-1809-F5)

Priority: Routine and Frequent

CFR Citation: None

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    07/07/04                    69 FR 35529

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Karen Raschke
Phone: 410 786-0016
Email: [email protected]

Related RIN: Related to 0938-AL29, Related to 0938-AM21, Related to 
0938-AM58, Related to 0938-AM95
RIN: 0938-AM99
_______________________________________________________________________




1122. TIME LIMITATION ON RECORDKEEPING REQUIREMENTS UNDER THE DRUG 
REBATE PROGRAM (CMS-2188-P)

Priority: Other Significant

CFR Citation: 42 USC 447.534

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Merged With 0938-AN55           08/10/04

Regulatory Flexibility Analysis Required: No

Government Levels Affected: Undetermined

Federalism:  Undetermined

Agency Contact: Marge Watchorn
Phone: 410 786-4361
Email: [email protected]

RIN: 0938-AN01
_______________________________________________________________________




1123. EXTENDED AVAILABILITY OF UNEXPENDED SCHIP FUNDS FROM THE 
APPROPRIATION FOR FYS 1998 THROUGH 2004; AUTHORITY TO USE A PORTION OF 
SCHIP FUNDS FOR MEDICAID EXPENDITURES (CMS-2187-N)

Priority: Other Significant

CFR Citation: None

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    07/23/04                    69 FR 44013

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Governmental Jurisdictions

Government Levels Affected: State

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

RIN: 0938-AN03
_______________________________________________________________________




1124. MANUFACTURERS' SUBMISSION OF AVERAGE SALES PRICE DATA FOR MEDICARE 
PART B DRUGS AND BIOLOGICALS (CMS-1380-F)

Priority: Other Significant

CFR Citation: None

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Rule                      09/16/04                    69 FR 55763

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses, Governmental Jurisdictions

Government Levels Affected: Federal

Agency Contact: Angela Mason
Phone: 410 786-7452
Email: [email protected]

RIN: 0938-AN05
_______________________________________________________________________




1125. SPECIAL RULES FOR EMPLOYER-SPONSORED DRUG PROGRAMS: SUBSIDIES TO 
ENCOURAGE RETENTION (TITLE I) (CMS-2199-P)

Priority: Economically Significant. Major under 5 USC 801.

CFR Citation: 42 CFR 423

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Merged With 0938-AN08           07/23/04

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses, Governmental Jurisdictions, 
Organizations

Government Levels Affected: None

Agency Contact: James Mayhew
Phone: 410 786-9344

[[Page 73181]]

Email: [email protected]

RIN: 0938-AN07
_______________________________________________________________________




1126. FY 2005 SCHIP ALLOTMENTS (CMS-2201-N)

Priority: Economically Significant

CFR Citation: 42 CFR 457

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Notice                          08/27/04                    69 FR 52700

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: State

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

RIN: 0938-AN11
_______________________________________________________________________




1127. PART A PREMIUMS FOR CALENDAR YEAR 2005 FOR THE UNINSURED AGED AND 
FOR CERTAIN DISABLED INDIVIDUALS WHO HAVE EXHAUSTED OTHER ENTITLEMENT 
(CMS-8022-N)

Priority: Economically Significant. Major under 5 USC 801.

CFR Citation: None

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Notice                          09/09/04                    69 FR 54673

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Clare McFarland
Phone: 410 786-6390
Email: [email protected]

RIN: 0938-AN15
_______________________________________________________________________




1128. INPATIENT HOSPITAL DEDUCTIBLE AND HOSPITAL AND EXTENDED CARE 
SERVICES COINSURANCE AMOUNTS FOR CALENDAR YEAR 2005 (CMS-8021-N)

Priority: Economically Significant. Major under 5 USC 801.

CFR Citation: None

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Notice                          09/09/04                    69 FR 54671

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Clare McFarland
Phone: 410 786-6390
Email: [email protected]

RIN: 0938-AN16
_______________________________________________________________________




1129. MEDICARE PART B MONTHLY ACTUARIAL RATES AND PREMIUM RATE BEGINNING 
JANUARY 1, 2005 (CMS-8020-N)

Priority: Economically Significant. Major under 5 USC 801.

CFR Citation: None

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Notice                          09/09/04                    69 FR 54674

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Clare McFarland
Phone: 410 786-6390
Email: [email protected]

RIN: 0938-AN18
_______________________________________________________________________




1130. FEE SCHEDULE FOR PAYMENT OF AMBULANCE SERVICES-UPDATE FOR CALENDAR 
YEAR 2005 (CMS-1267-N)

Priority: Economically Significant. Major under 5 USC 801.

CFR Citation: 42 CFR 414.620(f); 42 CFR 414.610(c)(5); 42 CFR 414.615; 
42 CFR 414.605

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Notice                          11/15/04                    69 FR 66918

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Ann Tayloe
Phone: 410 786-4546
Email: [email protected]

RIN: 0938-AN20
_______________________________________________________________________




1131. PROCEDURE FOR PRODUCING GUIDANCE DOCUMENTS DESCRIBING MEDICARE'S 
COVERAGE PROCESS (CMS-3141-N)

Priority: Info./Admin./Other

CFR Citation: None

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Notice                          09/24/04                    69 FR 57325

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Vadim Lubarsky
Phone: 410 786-0840
Email: [email protected]

RIN: 0938-AN21
_______________________________________________________________________




1132. AMENDMENT TO THE INTERIM FINAL REGULATION FOR MENTAL HEALTH PARITY 
(CMS-2152-F2)

Priority: Other Significant

CFR Citation: 45 CFR 146.136

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    07/23/04                    69 FR 43924

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: David Mlawsky
Phone: 410 786-6851

RIN: 0938-AN22
_______________________________________________________________________




1133. PHARMACY DISPENSING FEE (CMS-1280-F)

Priority: Other Significant

CFR Citation: None

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn                       11/09/04

Regulatory Flexibility Analysis Required: No

Government Levels Affected: Undetermined

Federalism:  Undetermined

Agency Contact: Angela Mason
Phone: 410 786-7452
Email: [email protected]

RIN: 0938-AN34

[[Page 73182]]

_______________________________________________________________________


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


Administration for Children and Families (ACF)



_______________________________________________________________________




1134. 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, 
the offset of Federal payments for purposes of collecting child 
support, and the safeguarding of information. This regulation would 
update various sections in 45 CFR chapter III to reflect the statutory 
changes.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            03/00/05

Regulatory Flexibility Analysis Required: No

Government Levels Affected: Local, State, Tribal

Agency Contact: Elizabeth C. Matheson, Director, Policy and Planning 
Division, Department of Health and Human Services, Administration for 
Children and Families, Office of Child Support Enforcement, 370 
L'Enfant Promenade SW., Washington, DC 20447
Phone: 202 401-9386
Email: [email protected]

RIN: 0970-AC01
_______________________________________________________________________




1135. DEVELOPMENTAL DISABILITIES AND BILL OF RIGHTS ACT

Priority: Substantive, Nonsignificant

Legal Authority: PL 106-402; 42 USC 15001 et seq

CFR Citation: 45 CFR 1385 to 1388

Legal Deadline: Final, Statutory, October 30, 2001.

Abstract: A notice of proposed rulemaking 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                            03/00/05

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Governmental Jurisdictions, Organizations

Government Levels Affected: Local, State, Tribal

Agency Contact: Elsbeth Wyatt, Program Specialist, Department of Health 
and Human Services, Administration for Children and Families, ADD HHH-
300F, 370 L'Enfant Promenade SW., Washington, DC 20447
Phone: 202 690-5841

RIN: 0970-AC07
_______________________________________________________________________




1136. ADMINISTRATIVE COSTS FOR CHILDREN IN TITLE IV-E FOSTER CARE

Priority: Other Significant

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

CFR Citation: 45 CFR 1356.60(c)

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/00/04

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
_______________________________________________________________________




1137. ADMINISTRATIVE COST SHARING UNDER TANF

Priority: Substantive, Nonsignificant

Legal Authority: 42 USC 1302

CFR Citation: 45 CFR 263; 45 CFR 263.14

Legal Deadline: None

Abstract: This proposed rule will 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                            03/00/05

Regulatory Flexibility Analysis Required: No

[[Page 73183]]

Small Entities Affected: No

Government Levels Affected: Local, 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-AC15
_______________________________________________________________________




1138.  CHILD CARE AND DEVELOPMENT FUND STATE MATCH 
PROVISIONS

Priority: Other Significant

Legal Authority: 42 USC 9858C

CFR Citation: 45 CFR 98.16

Legal Deadline: None

Abstract: This proposed rule revises the Child Care and Development 
Fund (CCDF) regulations to permit States to designate multiple public 
and/or private entities as eligible to receive private donations that 
may be certified as child care expenditures for purposes of receiving 
Federal CCDF matching funds.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            11/09/04                    69 FR 64881
Final Action                     To Be                       Determined

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: Local, State

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

RIN: 0970-AC18
_______________________________________________________________________


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


Administration for Children and Families (ACF)



_______________________________________________________________________




1139. HEAD START TRANSPORTATION

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

Legal Authority: 42 USC 9801 et seq

CFR Citation: 45 CFR 1310

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              01/16/04                     69 FR 2513
Final Action                    03/00/05

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

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

RIN: 0970-AC16
_______________________________________________________________________




1140.  REASONABLE QUANTITATIVE STANDARD FOR REVIEW AND 
ADJUSTMENT OF CHILD SUPPORT ORDERS

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

Legal Authority: 42 USC 1302

CFR Citation: 45 CFR 303

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              12/00/04

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: Local, State

Agency Contact: Elizabeth C. Matheson, Director, Policy and Planning 
Division, Department of Health and Human Services, Administration for 
Children and Families, Office of Child Support Enforcement, 370 
L'Enfant Promenade SW., Washington, DC 20447
Phone: 202 401-9386
Email: [email protected]

RIN: 0970-AC19

[[Page 73184]]

_______________________________________________________________________


Department of Health and Human Services (HHS)         Completed Actions


Administration for Children and Families (ACF)



_______________________________________________________________________




1141. CHILD SUPPORT ENFORCEMENT PROGRAM; FEDERAL TAX REFUND OFFSET

Priority: Other Significant

CFR Citation: 45 CFR 303.72

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    10/26/04                    69 FR 62413

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: State

Agency Contact: Elizabeth C. Matheson
Phone: 202 401-9386
Email: [email protected]

RIN: 0970-AC09
_______________________________________________________________________


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


Administration on Aging (AOA)



_______________________________________________________________________




1142. 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 February 2005.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            02/00/05

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses, Governmental Jurisdictions

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. 04-25762 Filed 12-10-04; 8:45 am]
BILLING CODE 4150-24-S