[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 37428]]



DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)






_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Office of the Secretary

21 CFR Ch. I

42 CFR Chs. I-V

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

Regulatory Agenda

AGENCY: Office of the Secretary, HHS.

ACTION: Semiannual agenda.

_______________________________________________________________________

SUMMARY: The Regulatory Flexibility Act of 1980 and Executive Order 
12866 require the semiannual publication of an inventory of all 
rulemaking actions under development or review by Federal departments 
and agencies. 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.

     When the Department publishes a regulatory proposal, 
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 
by clicking the Submit a Comment on the Regulation link on this 
site, which will open a blank comment form that includes 
instructions on how to submit the comment and what information must 
be provided for the comment to be considered. Comments submitted 
via www.regulations.gov are transmitted to the Department daily, 
and, as legally required, all comments are reviewed and taken into 
account if a final regulation is developed.

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

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

Dated: June 9, 2004.

 Ann C. Agnew,

Executive Secretary to the Department.

                                  Office of the Secretary--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
813         Safe Harbor for Arrangements Involving Federally Qualified Health Centers.............    0991-AB06
814         Claims Collection.....................................................................    0991-AB18
815         Salary Offset.........................................................................    0991-AB19
816         Medicare and Federal Health Care Programs: Fraud and Abuse; Revisions to the Waiver       0991-AB33
            Provisions of the OIG's Exclusion Authorities.........................................
----------------------------------------------------------------------------------------------------------------


                                    Office of the Secretary--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
817         Shared Risk Exception to the Safe Harbor Provisions...................................    0991-AA91
818         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...............................................................................
819         Safe Harbor for Waiver of Beneficiary Coinsurance and Deductible Amounts for a            0991-AB16
            Medicare SELECT Policy................................................................
820         Clarification of Terms and Application of Program Exclusion Authority for Submitting      0991-AB23
            Claims Containing Excessive Charges...................................................
821         Technical Revisions to HIPDB Data Collection Activities...............................    0991-AB31
----------------------------------------------------------------------------------------------------------------


                                   Office of the Secretary--Long-Term Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
822         Revisions to Regulations Addressing the OIG's Authority to Impose Civil Money             0991-AB03
            Penalties and Assessments.............................................................
823         Health Insurance Portability and Accountability Act--Enforcement......................    0991-AB29
----------------------------------------------------------------------------------------------------------------


[[Page 37429]]


                                   Office of the Secretary--Completed Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
824         Tax Refund Offset.....................................................................    0991-AB17
825         Implementation of the Equal Access to Justice Act in Agency Proceedings...............    0991-AB22
826         OIG Civil Money Penalties Under the Medicare Prescription Drug Discount Card Program..    0991-AB30
----------------------------------------------------------------------------------------------------------------


                 Substance Abuse and Mental Health Services Administration--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
827         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
----------------------------------------------------------------------------------------------------------------
828         Mandatory Guidelines for the Federal Workplace Drug Testing Program...................    0930-AA12
----------------------------------------------------------------------------------------------------------------


                  Substance Abuse and Mental Health Services Administration--Completed Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
829         Substance Abuse and Mental Health Services Administration (SAMHSA) Charitable Choice..    0930-AA11
830         Mandatory Guidelines for Federal Workplace Drug Testing Programs; Specimen Validity       0930-AA13
            Testing...............................................................................
----------------------------------------------------------------------------------------------------------------


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


                          Centers for Disease Control and Prevention--Completed Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
832         Procedures for Designating Classes of Employees as Members of the Special Exposure        0920-AA07
            Cohort Under the Energy Employee Occupational Illness Compensation Act of 2000........
----------------------------------------------------------------------------------------------------------------


                                   Food and Drug Administration--Prerule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
833         Safety Reporting Requirements for Human Drug and Biological Products..................    0910-AA97
834         Food Labeling; Prominence of Calories.................................................    0910-AF22
835         Food Labeling; Serving Sizes..........................................................    0910-AF23
836         Over-the-Counter (OTC) Drug Review--Sunscreen Products................................    0910-AF43
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[[Page 37430]]


                                Food and Drug Administration--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
837         Foreign and Domestic Establishment Registration and Listing Requirements for Drugs and    0910-AA49
            Biologics.............................................................................
838         Applications for FDA Approval To Market a New Drug; Complete Response Letter;             0910-AB34
            Amendments To Unapproved Applications.................................................
839         Prevention of Salmonella Enteritidis in Shell Eggs....................................    0910-AC14
840         Exception From General Requirements for Informed Consent; Request for Comments and        0910-AC25
            Information...........................................................................
841         Medical Devices; Anesthesiology Devices; Proposed Reclassification of Pressure            0910-AC30
            Regulators for Use With Medical Oxygen................................................
842         Food Standards: General Principles and Food Standards Modernization...................    0910-AC54
843         Positron Emission Tomography Drugs; Current Good Manufacturing Practices..............    0910-AC55
844         Reporting Information Regarding Falsification of Data.................................    0910-AC59
845         Definition of ``Serious Adverse Health Consequences'' Under the Public Health Security    0910-AF06
            and Bioterrorism Preparedness and Response Act of 2002................................
846         Health Claims.........................................................................    0910-AF09
847         Quality Standard Regulation Establishing Allowable Level for Arsenic in Bottled Water.    0910-AF10
848         Content and Format of Labeling for Human Prescription Drugs and Biologics;                0910-AF11
            Requirements for Pregnancy and Lactation..............................................
849         Cochineal Extract and Carmine Label Declaration.......................................    0910-AF12
850         Charging for Investigational Drugs....................................................    0910-AF13
851         Treatment Use of Investigational Drugs................................................    0910-AF14
852         Prescription Drug Marketing Act of 1987; Prescription Drug Amendments of 1992;            0910-AF16
            Policies, Requirements, and Administrative Procedures; Derivatives of Blood...........
853         Use of Ozone-Depleting Substances: Removal of Essential Use Designation; Albuterol....    0910-AF18
854         Revocation of the Status of Specific Products; Group A Streptococcus..................    0910-AF20
855         Latex Condoms: Special Controls.......................................................    0910-AF21
856         Blood Initiative--Regulations for Human Blood and Blood Components Intended for           0910-AF25
            Transfusion or for Further Manufacturing Use..........................................
857         Over-the-Counter (OTC) Drug Review--Cough/Cold (Bronchodilator) Products..............    0910-AF32
858         Over-the-Counter (OTC) Drug Review--Cough/Cold (Combination) Products.................    0910-AF33
859         Over-the-Counter (OTC) Drug Review--Cough/Cold (Nasal Decongestant) Products..........    0910-AF34
860         Over-the-Counter (OTC) Drug Review--Internal Analgesic Products.......................    0910-AF36
861         Over-the-Counter (OTC) Drug Review--Labeling of Drug Products for OTC Human Use.......    0910-AF37
862         Over-the-Counter (OTC) Drug Review--Weight Control Products...........................    0910-AF45
----------------------------------------------------------------------------------------------------------------


                                 Food and Drug Administration--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
863         Investigational New Drugs: Export Requirements for Unapproved New Drug Products.......    0910-AA61
864         Labeling for Human Prescription Drugs; Revised Format.................................    0910-AA94
865         Current Good Tissue Practice for Human Cell, Tissue, and Cellular and Tissue-Based        0910-AB28
            Product Establishments; Inspection and Enforcement....................................
866         CGMP for Blood and Blood Components: Notification of Consignees and Transfusion           0910-AB76
            Recipients Receiving Blood and Blood Components at Increased Risk of Transmitting HCV
            Infection (Lookback)..................................................................
867         Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Dietary         0910-AB88
            Ingredients and Dietary Supplements...................................................
868         Additional Safeguards for Children in Clinical Investigations of FDA-Regulated            0910-AC07
            Products..............................................................................
869         Medical Devices; Patient Examination and Surgeons' Gloves; Adulteration...............    0910-AC32
870         Amendments to the Performance Standard for Diagnostic X-Ray Systems and Their Major       0910-AC34
            Components............................................................................
871         Establishment and Maintenance of Records Pursuant to the Public Health Security and       0910-AC39
            Bioterrorism Preparedness and Response Act of 2002....................................
872         Registration of Food and Animal Feed Facilities.......................................    0910-AC40
873         Prior Notice of Imported Food Under the Public Health Security and Bioterrorism           0910-AC41
            Preparedness and Response Act of 2002.................................................
874         Presubmission Conferences.............................................................    0910-AC44
875         Human Subject Protection; Foreign Clinical Studies Not Conducted Under an                 0910-AF15
            Investigational New Drug Application..................................................
876         Blood Initiative--Revisions to Labeling and Storage Requirements for Blood and Blood      0910-AF26
            Components, Including Source Plasma...................................................

[[Page 37431]]

 
877         Over-the-Counter (OTC) Drug Review--Antiperspirant Products...........................    0910-AF30
878         Over-the-Counter (OTC) Drug Review--Cough/Cold (Antihistamine) Products...............    0910-AF31
879         Over-the-Counter (OTC) Drug Review--Ophthalmic Products...............................    0910-AF39
880         Over-the-Counter (OTC) Drug Review--Skin Protectant Products..........................    0910-AF42
881         Over-the-Counter (OTC) Drug Review--Vaginal Contraceptive Products....................    0910-AF44
----------------------------------------------------------------------------------------------------------------


                                 Food and Drug Administration--Long-Term Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
882         Requirements Pertaining to Sampling Services and Private Laboratories Used in             0910-AB96
            Connection With Imported Food.........................................................
883         Chronic Wasting Disease: Control of Food Products and Cosmetics Derived From Exposed      0910-AC21
            Animal Populations....................................................................
884         Requirements for Submission of In Vivo Bioequivalence Data............................    0910-AC23
885         Toll-Free Number for Reporting Adverse Events on Labeling for Human Drugs.............    0910-AC35
886         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.....
887         Submission of Standardized Electronic Study Data From Clinical Studies Evaluating         0910-AC52
            Human Drugs and Biologics.............................................................
888         Medical Gas Containers and Closures; Current Good Manufacturing Practice Requirements.    0910-AC53
889         Food Labeling: Food Allergen Ingredient Labeling......................................    0910-AF07
890         Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding     0910-AF08
            of Drugs; Revision of Certain Labeling Controls.......................................
891         Current Good Manufacutring Practices; Quality Control Procedures; Notification            0910-AF27
            Requirements; Records and Reports.....................................................
892         Infant Formula Quality Factors........................................................    0910-AF28
893         Over-the-Counter (OTC) Drug Review--External Analgesic Products.......................    0910-AF35
894         Over-the-Counter (OTC) Drug Review--Laxative Drug Products............................    0910-AF38
895         Over-the-Counter (OTC) Drug Review--Oral Health Care Products.........................    0910-AF40
----------------------------------------------------------------------------------------------------------------


                                 Food and Drug Administration--Completed Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
896         Over-the-Counter (OTC) Drug Review....................................................    0910-AA01
897         Infant Formula: Requirements Pertaining to Good Manufacturing Practice, Quality           0910-AA04
            Control Procedures, Quality Factors, Notification Requirements, and Records and
            Reports...............................................................................
898         Determination That Informed Consent Is Infeasible or Is Contrary to the Best Interest     0910-AA89
            of Recipients.........................................................................
899         Blood Initiative......................................................................    0910-AB26
900         Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-    0910-AB27
            Based Products........................................................................
901         Supplements and Other Changes to an Approved Application..............................    0910-AB61
902         Current Good Manufacturing Practice for Medicated Feeds...............................    0910-AB70
903         Requirements for Submission of Labeling for Human Prescription Drugs and Biologics in     0910-AB91
            Electronic Format.....................................................................
904         Use of Materials Derived From Bovine and Ovine Animals in FDA-Regulated Products......    0910-AC19
905         Bar Code Label Requirements for Human Drug Products and Blood.........................    0910-AC26
906         Administrative Detention of Food for Human or Animal Consumption Under the Public         0910-AC38
            Health Security and Bioterrorism Preparedness and Response Act of 2002................
907         Requirements for Liquid Medicated Feed and Free-Choice Medicated Feed.................    0910-AC43
908         Biological Products; Bacterial Vaccines and Toxoids; Implementation of Efficacy Review    0910-AC56
909         Revision of the Requirements for Spore-Forming Microorganisms.........................    0910-AC57
910         Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Human Food      0910-AC58
            (Part 110) (Completion of a Section 610 Review).......................................
911         Over-the-Counter (OTC) Drug Review--Antidiarrheal Products............................    0910-AF29
----------------------------------------------------------------------------------------------------------------


[[Page 37432]]


                        Health Resources and Services Administration--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
912         National Practitioner Data Bank for Adverse Information on Physicians and Other Health    0906-AA41
            Care Practitioners: Medical Malpractice Payments Reporting Requirements...............
913         Designation of Medically Underserved Populations and Health Professional Shortage         0906-AA44
            Areas.................................................................................
914         Intestines Added to the Definition of Organs Covered by the Rules Governing the           0906-AA62
            Operation of the Organ Procurement and Transplantation Network (OPTN).................
915         Notice of Proposed Rulemaking to Amend the Final Rule Governing the Operation of the      0906-AA63
            Organ Procurement and Transplantation Network (OPTN)..................................
916         National Vaccine Injury Compensation Program; Revisions and Additions to the Vaccine      0906-AA66
            Injury Table..........................................................................
917         Liability Protection for Certain Free Clinic Health Professionals.....................    0906-AA67
918         National Vaccine Injury Compensation Program: Calculation of Average Cost of a Health     0906-AA68
            Insurance Policy......................................................................
----------------------------------------------------------------------------------------------------------------


                         Health Resources and Services Administration--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
919         Interim Final Rule for the Smallpox Emergency Personnel Protection Program: Smallpox      0906-AA60
            (Vaccinia) Vaccine Injury Table.......................................................
920         Smallpox Vaccine Injury Compensation Program: Administrative Implementation...........    0906-AA61
921         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
----------------------------------------------------------------------------------------------------------------
922         National Practitioner Data Bank for Adverse Information on Physicians and Other Health    0906-AA57
            Care Practitioners: Reporting Adverse and Negative Actions............................
----------------------------------------------------------------------------------------------------------------


                               National Institutes of Health--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
923         Undergraduate Scholarship Program Regarding Professions Needed by the National            0925-AA10
            Institutes of Health (NIH)............................................................
924         National Institutes of Health Training Grants.........................................    0925-AA28
925         Standards for a National Chimpanzee Sanctuary System..................................    0925-AA31
926         National Institutes of Health AIDS Research Loan Repayment Program....................    0925-AA32
927         National Institutes of Health Extramural Loan Repayment Program for Clinical              0925-AA33
            Researchers...........................................................................
928         National Institutes of Health Pediatric Research Loan Repayment Program...............    0925-AA34
929         National Institutes of Health Loan Repayment Program for Health Disparities Research..    0925-AA35
930         National Institutes of Health Clinical Research Loan Repayment Program for Individuals    0925-AA36
            From Disadvantaged Backgrounds........................................................
931         National Institute of Child Health and Human Development Contraception and Infertility    0925-AA41
            Research Loan Repayment Program.......................................................
----------------------------------------------------------------------------------------------------------------


                                 National Institutes of Health--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
932         National Institutes of Health Loan Repayment Program for Research Generally...........    0925-AA18
933         National Institutes of Health Center Grants...........................................    0925-AA24
----------------------------------------------------------------------------------------------------------------


[[Page 37433]]


                                National Institutes of Health--Completed Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
934         Scientific Peer Review of Research Grant Applications and Research and Development        0925-AA20
            Contract Projects.....................................................................
----------------------------------------------------------------------------------------------------------------


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


                            Office of Public Health and Science--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
936         Public Health Service Policies on Research Misconduct.................................    0940-AA04
----------------------------------------------------------------------------------------------------------------


                              Office of Public Health and Science--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
937         Public Health Service Standards for the Protection of Research Misconduct                 0940-AA01
            Whistleblowers........................................................................
938         Human Subjects Protection Regulations: Institutional Review Boards Registration           0940-AA06
            Requirements..........................................................................
939         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
----------------------------------------------------------------------------------------------------------------
940         Human Subjects Protection Regulations: Training and Education Requirements for            0940-AA08
            Institutional Officials, Institutional Review Board Members and Staff, Human
            Protections Administrators, and Investigator..........................................
----------------------------------------------------------------------------------------------------------------


                          Centers for Medicare & Medicaid Services--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
941         Home Health Agency (HHA) Conditions of Participation (CoPs) (CMS-3819-P)..............    0938-AG81
942         End Stage Renal Disease (ESRD) Conditions for Coverage (CMS-3818-P) (Section 610          0938-AG82
            Review)...............................................................................
943         Hospital Conditions of Participation: Requirements for Approval and Reapproval of         0938-AH17
            Transplant Centers To Perform Organ Transplants (CMS-3835-P)..........................
944         Hospice Care--Conditions of Participation (CMS-3844-P)................................    0938-AH27
945         Standard Unique National Health Plan Identifiers (CMS-6017-P).........................    0938-AH87
946         Appeals of Carrier Determination that a Supplier Fails to Meet the Requirements for       0938-AI49
            Medicare Billing Privileges (CMS-6003-P2).............................................
947         Rural Health Clinics: Amendments to Participation Requirements and Payment Provisions     0938-AJ17
            and Establishment of a Quality Assessment and Improvement Program (CMS-1910-P2).......
948         Supplier Standards for Home Oxygen, Therapeutic Shoes, and Home Nutrition Therapy (CMS-   0938-AJ98
            6010-P)...............................................................................
949         Health Insurance Reform: Claims Attachments Standards (CMS-0050-P)....................    0938-AK62
950         Organ Procurement Organization Conditions for Coverage (CMS-3064-P)...................    0938-AK81
951         Use of Restraint and Seclusion in Medicare and Medicaid Participating Facilities That     0938-AL26
            Provide Inpatient or Residential Care (CMS-2130-P)....................................

[[Page 37434]]

 
952         Provider Reimbursement Determinations and Appeals (CMS-1727-P)........................    0938-AL54
953         Health Coverage Portability's Request for Information on Benefit-Specific Waiting         0938-AL64
            Periods (CMS-2150-NC).................................................................
954         Revisions to Conditions for Coverage for Ambulatory Surgical Centers (CMS-3887-P).....    0938-AL80
955         Health Coverage Portability: Tolling Certain Time Periods and Interactions With Family    0938-AL88
            and Medical Leave Act (CMS-2158-P)....................................................
956         Modifications to Electronic Transactions and Code Sets (CMS-0009-P)...................    0938-AM50
957         Changes to the Hospital Outpatient Prospective System and Calendar Year 2005 Payment      0938-AM75
            Rates (CMS-1427-P)....................................................................
958         Ticket to Work: Defining Individuals with Potentially Severe Disabilities and             0938-AM79
            Providing a Work Threshold (CMS-2172-P)...............................................
959         Payment Error Rate Measurement (PERM) Program (CMS-2186-P)............................    0938-AM86
960         Requirements for Long-Term Care Facilities: Hospice Services (CMS-3140-P).............    0938-AM87
961         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)...................................................
962         Revisions to Payment Policies Under the Physician Fee Schedule for Calendar Year 2005     0938-AM90
            (CMS-1429-P)..........................................................................
963         Revised Civil Money Penalties, Assessments, Exclusions, and Related Appeals Procedures    0938-AM98
            (CMS-6146-P)..........................................................................
964         Physician Referral for Nuclear Medicine Services and Supplies (CMS-1261-P)............    0938-AN04
965         Medicare Advantage Program Title II (CMS-4069-P)......................................    0938-AN06
966         Special Rules for Employer-Sponsored Drug Programs: Subsidies to Encourage Retention      0938-AN07
            (Title I) (CMS-2199-P)................................................................
967         Medicare Drug Benefit Effective Calendar Year 2006 (Title I) (CMS-4068-P).............    0938-AN08
968         Enhanced DSH Treatment for Certain Hospitals (CMS-2198-P).............................    0938-AN09
969         Prior Determination Process (CMS-6024-P)..............................................    0938-AN10
970         Competitive Acquisition for Certain Durable Medical Equipment (DME), Prosthetics,         0938-AN14
            Orthotics, and Supplies (CMS-1270-P)..................................................
971         Update of the List of Covered Procedures for Ambulatory Surgical Centers for 2005 (CMS-   0938-AN23
            1478-PN)..............................................................................
972         Revisions to HIPAA Code Sets (CMS-0013-P).............................................    0938-AN25
973         Payment for Clinical Laboratory Tests (CMS-1494-P)....................................    0938-AN26
974         Prospective Payment System for Long Term Care Hospitals: Annual Payment Rate Updates      0938-AN28
            and Policy Changes for 2006 (CMS-1483-P)..............................................
----------------------------------------------------------------------------------------------------------------


                           Centers for Medicare & Medicaid Services--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
975         Use of Restraint and Seclusion in Residential Treatment Facilities Providing Inpatient    0938-AJ96
            Psychiatric Services to Individuals Under Age 21 (CMS-2065-F).........................
976         Revisions to the Medicare Appeals Process (CMS-4004-FC)...............................    0938-AL67
977         Electronic Medicare Claims Submission (CMS-0008-F)....................................    0938-AM22
978         Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities--      0938-AM46
            Update for FY 2005 (CMS-1249-N).......................................................
979         Title I: Non-Federal Governmental Plans Exempt From HIPAA (CMS-2033-F)................    0938-AM71
980         Revisions to the Appeals Process for Initial Claim Determinations (CMS-4064-FC).......    0938-AM73
981         Conditions for Coverage of Power Mobility Devices, including Powered Wheelchairs and      0938-AM74
            Power-Operated Vehicles Scooter(CMS-3017-IFC).........................................
982         Hospice Wage Index FY 2005 (CMS-1264-N)...............................................    0938-AM78
983         Changes to the Hospital Inpatient Prospective Payment System and FY 2005 Rates (CMS-      0938-AM80
            1428-F)...............................................................................
984         Prospective Payment System for Inpatient Rehabilitation Facilities for FY 2005 (CMS-      0938-AM82
            1360-N)...............................................................................
985         Home Health Prospective Payment System Rate Update FY 2005 (CMS-1265-P)...............    0938-AM93
986         Changes to Medicare Payment for Drugs and Physician Fee Schedule Payments for Calendar    0938-AM97
            Year 2004--Correction Notice CMS-1372-IFC)............................................
987         Physicians' Referrals to Health Care Entities With Which They Have Financial              0938-AM99
            Relationships: Extension of Partial Delay of Effective Date (CMS-1809-F5).............
988         Time Limitation on Record keeping Requirements Under the Drug Rebate Program (CMS-2188-   0938-AN01
            P)....................................................................................
989         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)...............................................................................
990         FY 2005 SCHIP Allotments (CMS-2201-N).................................................    0938-AN11
991         Schedule for Publishing Medicare Final Regulations After a Proposed or Interim Final      0938-AN12
            Regulation (CMS-9026-N)...............................................................
992         Evaluation Criteria and Standards for Quality Improvement Program Contracts (CMS-3142-    0938-AN13
            NC)...................................................................................

[[Page 37435]]

 
993         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).........................
994         Inpatient Hospital Deductible and Hospital and Extended Care Services Coinsurance         0938-AN16
            Amounts for Calendar Year 2005 (CMS-8021-N)...........................................
995         Medicare Part B Monthly Actuarial Rates and Premium Rate Beginning January 1, 2005        0938-AN18
            (CMS-8020-N)..........................................................................
996         Fee Schedule for Payment of Ambulance Services-Update for Calendar Year 2005 (CMS-1267-   0938-AN20
            N)....................................................................................
997         Procedure for Producing Guidance Documents Describing Medicare's Coverage Process (CMS-   0938-AN21
            3141-N)...............................................................................
998         Amendment to the Interim Final Regulation for Mental Health Parity (CMS-2152-F2)......    0938-AN22
999         Medicare Ambulance Fee Schedule Update (CMS-1492-IFC).................................    0938-AN24
1000        Medicare Secondary Payer (MSP): Workmen's Compensation (CMS-1272-FC)..................    0938-AN27
1001        Random Prepayment Review (CMS-6022-IFC)...............................................    0938-AN31
1002        Additional Payments for Certain Medicare Part B Drugs (CMS-1280-FC)...................    0938-AN34
1003        Federal Enforcement in Group and Individual Health Insurance Markets (CMS-2019-F).....    0938-AN35
1004        Fire Safety Requirements for Certain Health Care Facilities, Amendment (CMS-3047-F2)..    0938-AN36
----------------------------------------------------------------------------------------------------------------


                           Centers for Medicare & Medicaid Services--Long-Term Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
1005        Requirements for Establishing and Maintaining Medicare Billing Privileges (CMS-6002-F)    0938-AH73
1006        Medicare Outcome and Assessment Information Set (OASIS) Data Reporting Requirements       0938-AJ10
            (CMS-3006-F)..........................................................................
1007        Hospital Conditions of Participation: Laboratory Services (CMS-3014-F)................    0938-AJ29
1008        Medicare Hospice Care Amendments (CMS-1022-F).........................................    0938-AJ36
1009        Physicians' Referrals to Health Care Entities With Which They Have Financial              0938-AK67
            Relationships--Phase II (CMS-1810-IFC)................................................
1010        Continuation of Medicare Entitlement When Disability Benefit Ends Because of              0938-AK94
            Substantial Gainful Activity (CMS-4018-F).............................................
1011        Medicare Program; Interest Calculation (CMS-6014-F)...................................    0938-AL14
1012        Health Coverage Portability for Group Health Plans and Group Health Insurance Issuers     0938-AL43
            (CMS-2151-F)..........................................................................
1013        Prospective Payment System for Inpatient Psychiatric Facilities FY 2004 (CMS-1213-F)..    0938-AL50
1014        DMERC Service Areas and Related Matters (CMS-1219-F)..................................    0938-AL76
1015        Procedures for Maintaining Code Lists in the Negotiated National Coverage                 0938-AM36
            Determinations for Clinical Diagnostic Laboratory Services (CMS-3119-F)...............
1016        Hospital Patients' Rights CoP--Standard Safety Compliance Committees (CMS-3120-P).....    0938-AM39
1017        Requirements for Nursing Homes To Identify the Number of Licensed and Unlicensed          0938-AM55
            Nurses (CMS-3121-F)...................................................................
1018        Covered Outpatient Drugs Under the Medicaid Drug Rebate Program (CMS-2174-P)..........    0938-AM81
1019        Revisions to Cost Sharing Regulations (CMS-2144-P)....................................    0938-AM94
1020        Medicare Program; Hospital Outpatient Prospective Payment System Payment Reform for       0938-AM96
            Calendar Year 2004 CMS-1371-IFC.......................................................
1021        Payment for Respiratory Assist Devices with Bi-level Capability and a Back-up Rate        0938-AN02
            (CMS-1167-F)..........................................................................
1022        Manufacturers' Submission of Average Sales Price Data for Medicare Part B Drugs and       0938-AN05
            Biologicals (CMS-1380-IFC)............................................................
1023        Nondiscrimination In Post-Hospital Referral to Home Health Agencies and Other Entities    0938-AN19
            (CMS-1224-F)..........................................................................
1024        Nondiscrimination in Health Coverage and Bonafide Wellness Plans in the Group Market      0938-AN29
            (CMS-2022-F)..........................................................................
1025        Hospital Conditions of Participation: Patients' Rights (CMS-3018-F)...................    0938-AN30
----------------------------------------------------------------------------------------------------------------


                           Centers for Medicare & Medicaid Services--Completed Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
1026        Health Insurance Reform: Standard Unique Health Care Provider Identifier (CMS-0045-F).    0938-AH99
1027        Coverage of Religious Nonmedical Health Care Institutions (CMS-1909-F)................    0938-AI93
1028        All Provider Bad Debt Payment (CMS-1126-F)............................................    0938-AK02
1029        Review of National Coverage Determinations and Local Coverage Determinations (CMS-3063-   0938-AK60
            F)....................................................................................
1030        Rate of Reimbursement of Photocopy Expenses for Quality Improvement Organizations (CMS-   0938-AK68
            3055-F)...............................................................................

[[Page 37436]]

 
1031        Elimination of Statement of Intent Procedures for Filing Medicare Claims (CMS-1185-F).    0938-AK79
1032        Permitting Premium Reductions as Additional Benefits Under Medicare+Choice Plans (CMS-    0938-AL49
            6016-F)...............................................................................
1033        Changes to the Hospital Outpatient Prospective Payment System and Calendar Year 2004      0938-AL91
            Payment Rates (CMS-1471-F)............................................................
1034        Criteria for Determining Whether a Drug is Considered Usually Self-Administered (CMS-     0938-AM13
            1228-P)...............................................................................
1035        Inpatient Hospital Deductible and Hospital and Extended Care Services Coinsurance         0938-AM31
            Amounts for Calendar Year 2004 (CMS-8016-N)...........................................
1036        Monthly Actuarial Rates and Monthly Supplementary Medical Insurance Premium Rate          0938-AM32
            Beginning January 1, 2004 (CMS-8017-N)................................................
1037        Part A Premiums for Calendar Year 2004 for the Uninsured Aged and for Certain Disabled    0938-AM33
            Individuals Who Have Exhausted Other Entitlement (CMS-8018-N).........................
1038        Grants to States for Operation of Qualified High Risk Pools (CMS-2179-FC).............    0938-AM42
1039        Fee Schedule for Payment of Ambulance Services Update for Calendar Year 2004 (CMS-1232-   0938-AM44
            FCC)..................................................................................
1040        Exclusion of Medicare Benefits for Aliens Not Lawfully Present in the United States       0938-AM47
            (CMS-1222-FC).........................................................................
1041        Revised Civil Money Penalties, Assessments, Exclusions, and Related Appeals Procedures    0938-AM54
            (CMS-6146-P)..........................................................................
1042        Changes to the Criteria for Being Classified as an Inpatient Rehabilitation Facility      0938-AM72
            (CMS-1262-F)..........................................................................
1043        Prospective Payment System for Long-Term Care Hospitals: Annual Payment Rate Updates      0938-AM84
            and Policy Changes (Effective 7/1/04) (CMS-1263-F)....................................
1044        Disproportionate Share Hospital (DSH) Payments Institutions for Mental Disease (IMDs)     0938-AM89
            (CMS-2062-N)..........................................................................
1045        Physicians' Referrals to Health Care Entities With Which They Have Financial              0938-AM95
            Relationships: Extension of Partial Delay of Effective Date (CMS-1809-F4).............
1046        Notice of One-Time Appeal Process for Hospital Wage Index Classification (CMS-1373-N).    0938-AN00
----------------------------------------------------------------------------------------------------------------


                          Administration for Children and Families--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
1047        Safeguarding Child Support and Expanded Federal Parent Locator Services (FPLS)            0970-AC01
            Information...........................................................................
1048        Developmental Disabilities and Bill of Rights Act.....................................    0970-AC07
1049        Administrative Costs for Children in Title IV-E Foster Care...........................    0970-AC14
1050        Administrative Cost Sharing Under TANF................................................    0970-AC15
----------------------------------------------------------------------------------------------------------------


                           Administration for Children and Families--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
1051        Child Support Enforcement Program; Federal Tax Refund Offset..........................    0970-AC09
1052        Head Start Transportation.............................................................    0970-AC16
----------------------------------------------------------------------------------------------------------------


                           Administration for Children and Families--Completed Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
1053        Child Support Enforcement for Indian Tribes...........................................    0970-AB73
1054        Charitable Choice Provisions Applicable to the Temporary Assistance for Needy Families    0970-AC12
            Program...............................................................................
1055        Community Services Block Grant Charitable Choice......................................    0970-AC13
----------------------------------------------------------------------------------------------------------------


[[Page 37437]]


                                  Administration on Aging--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
1056        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)



_______________________________________________________________________




813. SAFE HARBOR FOR ARRANGEMENTS INVOLVING FEDERALLY QUALIFIED HEALTH 
CENTERS

Priority: Substantive, Nonsignificant

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

CFR Citation: 42 CFR 1001

Legal Deadline: None

Abstract: This rule would set forth a new anti-kickback safe harbor 
addressing remuneration between federally qualified health centers and 
certain service providers where a significant community benefit exists.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/00/04

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

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

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




814. 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                            07/00/04
NPRM Comment Period End         09/00/04
Final Rule                      11/00/04

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

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

RIN: 0991-AB18
_______________________________________________________________________




815. 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                            07/00/04
NPRM Comment Period End         09/00/04
Final Rule                      11/00/04

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

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

RIN: 0991-AB19
_______________________________________________________________________




816.  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

[[Page 37438]]

of 2003, this rule would revise the OIG's exclusion authority to permit 
any Federal healhcare program to request a waiver of an OIG exclusion 
imposed under sections 1128(a)(1), (a)(3), or (a)(4) of the Social 
Security Act.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            10/00/04
NPRM Comment Period End         11/00/04

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

RIN: 0991-AB33
_______________________________________________________________________


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


Office of the Secretary (OS)



_______________________________________________________________________




817. SHARED RISK EXCEPTION TO THE SAFE HARBOR PROVISIONS

Priority: Substantive, Nonsignificant

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

CFR Citation: 42 CFR 1001

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

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

ANPRM                           05/23/97                    62 FR 28410
ANPRM Comment Period End        06/09/97
Interim Final Rule              11/19/99                    64 FR 63504
Final Rule                      12/00/04

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

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

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




818. 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.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/06/00                    65 FR 76460
Final Action                    07/00/04

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
_______________________________________________________________________




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

Priority: Substantive, Nonsignificant

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

CFR Citation: 42 CFR 1001

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

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

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

[[Page 37439]]

Government Levels Affected: None

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

RIN: 0991-AB16
_______________________________________________________________________




820. 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                    01/00/05

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

RIN: 0991-AB23
_______________________________________________________________________




821.  TECHNICAL REVISIONS TO HIPDB DATA COLLECTION 
ACTIVITIES

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

Legal Authority: Sec 221(a), PL 104-91; Sec 1128E(b)(2), Social 
Security Act

CFR Citation: 45 CFR 61

Legal Deadline: None

Abstract: This rule makes technical changes to the Healthcare Integrity 
and Protection Data Bank data collection reporting requirements by 
clarifying the types of personal numeric identifiers that may be 
reported to the data bank in connection with adverse actions. The rule 
classifies that in lieu of a Social Security Number (SSN), an 
individual taxpayer identification number (ITIN) may be reported to the 
data bank when, in those limited situations, an individual does not 
have a SSN.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              10/00/04
Interim Final Rule Comment 
Period End                      11/00/04

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

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

RIN: 0991-AB31
_______________________________________________________________________


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


Office of the Secretary (OS)



_______________________________________________________________________




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

Priority: Substantive, Nonsignificant

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

CFR Citation: 42 CFR 1003

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                             To Be                       Determined

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

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

RIN: 0991-AB03
_______________________________________________________________________




823. 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: Not Yet Determined

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.

[[Page 37440]]

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                             To Be                       Determined

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)         Completed Actions


Office of the Secretary (OS)



_______________________________________________________________________




824. TAX REFUND OFFSET

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

CFR Citation: 45 CFR 31

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Rule                      12/18/03                    68 FR 70444

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Katherine M. Drews
Phone: 202 619-0150

RIN: 0991-AB17
_______________________________________________________________________




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

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

CFR Citation: 45 CFR 13

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Rule                      01/21/04                     69 FR 2843

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Katherine M. Drews
Phone: 202 619-0150

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




826.  OIG CIVIL MONEY PENALTIES UNDER THE MEDICARE 
PRESCRIPTION DRUG DISCOUNT CARD PROGRAM

Priority: Substantive, Nonsignificant

Legal Authority: Sec 101, PL 108-173; Sec 1860D-31, Social Security Act

CFR Citation: 42 CFR 1003

Legal Deadline: None

Abstract: This rule sets forth the OIG's new authority for imposing 
civil money penalties against endorsed sponsors under the medicare 
prescription drug discount card program that knowingly engage in false 
or misleading marketing practicies; overcharge program enrollees; or 
misuse transtional assistance funds.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              05/19/04                    69 FR 28842
Interim Final Rule Comment 
Period End                      07/19/04

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

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

RIN: 0991-AB30
_______________________________________________________________________


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


Substance Abuse and Mental Health Services Administration (SAMHSA)



_______________________________________________________________________




827. 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                            11/00/04

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, Rockville, MD 20857
Phone: 301 443-2619

RIN: 0930-AA10

[[Page 37441]]

_______________________________________________________________________


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


Substance Abuse and Mental Health Services Administration (SAMHSA)



_______________________________________________________________________




828. 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

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)         Completed Actions


Substance Abuse and Mental Health Services Administration (SAMHSA)



_______________________________________________________________________




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

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

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

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Rule                      09/30/03                    68 FR 56429

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: Federal

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

Agency Contact: Winnie Mitchell
Phone: 301 443-2324
Fax: 301 443-0247

RIN: 0930-AA11
_______________________________________________________________________




830.  MANDATORY GUIDELINES FOR FEDERAL WORKPLACE DRUG 
TESTING PROGRAMS; SPECIMEN VALIDITY TESTING

Priority: Other Significant

Legal Authority: PL 100-71, sec 503

CFR Citation: None

Legal Deadline: None

Abstract: HHS is establishing standards for determining the validity of 
urine specimens collected under the Mandatory Guidelines for Federal 
Workplace Drug Testing Programs. These standards ensure that specimen 
validity testing (SVT) and reporting procedures are uniformly applied 
to all Federal agency urine specimens when a validity test is 
conducted.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Notice                          04/13/04                    69 FR 19644

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: Local, State

Agency Contact: Walter F. Vogel, CSAP, Department of Health and Human 
Services, Substance Abuse and Mental Health Services Administration, 
CSAP, Suite 815, Rockville II, Rockville, MD 20857
Phone: 301 443-6014

RIN: 0930-AA13
_______________________________________________________________________


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


Centers for Disease Control and Prevention (CDC)



_______________________________________________________________________




831. 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                            10/00/04

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

[[Page 37442]]

_______________________________________________________________________


Department of Health and Human Services (HHS)         Completed Actions


Centers for Disease Control and Prevention (CDC)



_______________________________________________________________________




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

Priority: Substantive, Nonsignificant

CFR Citation: 42 CFR 83

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    05/28/04                    69 FR 30763

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Larry Elliott
Phone: 513 841-4498

RIN: 0920-AA07
_______________________________________________________________________


Department of Health and Human Services (HHS)             Prerule Stage


Food and Drug Administration (FDA)



_______________________________________________________________________




833. SAFETY REPORTING REQUIREMENTS FOR HUMAN DRUG AND BIOLOGICAL 
PRODUCTS

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

Unfunded Mandates: Undetermined

Legal Authority: 42 USC 216; 42 USC 241; 42 USC 242a; 42 USC 262; 42 
USC 263; 42 USC 263a to 263-n; 42 USC 264; 42 USC 300aa; 21 USC 321; 21 
USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 360; 21 USC 360b to 
360j; 21 USC 361a; 21 USC 371; 21 USC 374; 21 USC 375; 21 USC 379e; 21 
USC 381

CFR Citation: 21 CFR 310; 21 CFR 312; 21 CFR 314; 21 CFR 320; 21 CFR 
600; 21 CFR 601; 21 CFR 606

Legal Deadline: None

Abstract: This regulation is one component of the Secretary's 
initiative to reduce medical errors. The proposed rule would amend the 
expedited and periodic safety reporting regulations for human drugs and 
biological products to revise certain definitions and reporting formats 
as recommended by the International Conference on Harmonisation and to 
define new terms; to add to or revise current reporting requirements; 
to revise certain reporting time frames; and propose other revisions to 
these regulations to enhance the quality of safety reports received by 
FDA.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            03/14/03                    68 FR 12406
NPRM Comment Period Extended    06/18/03
NPRM Comment Period End         07/14/03
NPRM Comment Period Extension 
End                             10/14/03
Comment Review End              09/00/04

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: Undetermined

Agency Contact: Elizabeth J Sadove, Regulatory Counsel, Office of 
Regulatory Policy, Department of Health and Human Services, Food and 
Drug Administration, Center for Drug Evaluation and 
ResearchAdministration, 5515 Security Lane, Suite 1101 (HFD-7), 
Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562

RIN: 0910-AA97
_______________________________________________________________________




834.  FOOD LABELING; PROMINENCE OF CALORIES

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

Unfunded Mandates: Undetermined

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

CFR Citation: 21 CFR 101.9

Legal Deadline: None

Abstract: In response to the Report of the Working Group on Obesity 
(OWG) that FDA issued on March 12, 2004, the agency will issue an 
advance notice of proposed rulemaking (ANPRM) in its efforts to combat 
the nation's obesity problem. The ANPRM will request comments on ways 
to give more prominence to ``calories'' on the food label.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

ANPRM                           10/00/04

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Federalism:  Undetermined

Agency Contact: Shellee Anderson, Team Leader, Department of Health and 
Human Services, Food and Drug Administration, HFS-830, 5100 Paint 
Branch Parkway, College Park, MD 20740
Phone: 301 436-1450
Fax: 301-436-2636
Email: [email protected]

RIN: 0910-AF22
_______________________________________________________________________




835.  FOOD LABELING; SERVING SIZES

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

Unfunded Mandates: Undetermined

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

CFR Citation: 21 CFR 101.9(b)

Legal Deadline: None

Abstract: In response to the Report of the Working Group on Obesity 
(OWG) that FDA issued on March 12, 2004, the agency will issue an 
advance notice of proposed rulemaking (ANPRM) in its efforts to combat 
the nation's obesity problem. The ANPRM will request comments on 
changes to the agency's nutrition labeling regulations on serving size 
and comments on allowance of truthful, nonmisleading and useful 
approaches for promoting consumption of smaller portion sizes.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

ANPRM                           10/00/04

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

[[Page 37443]]

Federalism:  Undetermined

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

RIN: 0910-AF23
_______________________________________________________________________




836.  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; 21USC 371a; 21 USC 331; 21 USC 360; 21 USC 360b; 21 USC 361; 21 
USC 371

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

ANPRM (Sunscreen and Insect 
Repellent)                      11/00/04
NPRM (UVA/UVB)                  11/00/04

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, 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)



_______________________________________________________________________




837. FOREIGN AND DOMESTIC ESTABLISHMENT REGISTRATION AND LISTING 
REQUIREMENTS FOR DRUGS AND BIOLOGICS

Priority: Other Significant

Legal Authority: 21 USC 321; 21 USC 331; 21 USC 351; 21 USC 352; 21 USC 
355; 21 USC 360; 21 USC 360b; 21 USC 371; 21 USC 374; 42 USC 262; 42 
USC 264; 42 USC 271

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

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            11/00/04

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: None

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

RIN: 0910-AA49
_______________________________________________________________________




838. 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                            07/00/04

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Federalism:  Undetermined

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

RIN: 0910-AB34

[[Page 37444]]

_______________________________________________________________________




839. PREVENTION OF SALMONELLA ENTERITIDIS IN SHELL EGGS

Priority: Economically Significant. Major under 5 USC 801.

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

Legal Authority: 21 USC 321; 21 USC 342; 21 USC 371; 21 USC 381; 21 USC 
393; 42 USC 243; 42 USC 264; 42 USC 271; . . .

CFR Citation: 21 CFR 16; 21 CFR 116; 21 CFR 118

Legal Deadline: None

Abstract: In July 1999, the Food and Drug Administration (FDA) and the 
Food Safety Inspection Service (FSIS) committed to developing an action 
plan to address the presence of salmonella enteritidis (SE) in shell 
eggs and egg products using a farm-to-table approach. FDA and FSIS held 
a public meeting on August 26, 1999, to obtain stakeholder input on the 
draft goals, as well as to further develop the objectives and action 
items for the action plan. The Egg Safety Action Plan was announced on 
December 11, 1999. The goal of the Action Plan is to reduce egg-related 
SE illnesses by 50 percent by 2005 and eliminate egg-related SE 
illnesses by 2010.
The Egg Safety Action Plan consists of eight objectives covering all 
stages of the farm-to-table continuum as well as support functions. On 
March 30, 2000 (Columbus, OH), April 6, 2000 (Sacramento, CA), and July 
31, 2000 (Washington, DC), joint public meetings were held by FDA and 
FSIS to solicit and discuss information related to the implementation 
of the objectives in the Egg Safety Action Plan.
In accordance with discussions at the public meetings, FDA intends to 
publish a proposed rule to require that shell eggs be produced under a 
plan that is designed to prevent transovarian SE from contaminating 
eggs at the farm during production.
FDA intends to discuss in its proposal certain provisions of the 1999 
Food Code that are relevant to how eggs are handled, prepared, and 
served at certain retail establishments. In addition, the agency plans 
to consider whether it should require provisions for certain retail 
establishments that serve populations most at risk of egg-related 
illness (i.e., the elderly, children, and the immunocompromised).

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/00/04

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: Undetermined

Federalism:  Undetermined

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

RIN: 0910-AC14
_______________________________________________________________________




840. 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 an amendment to the 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                            12/00/04

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
_______________________________________________________________________




841. 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

[[Page 37445]]

_______________________________________________________________________




842. 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                            09/00/04

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: Undetermined

Federalism:  Undetermined

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

RIN: 0910-AC54
_______________________________________________________________________




843. POSITRON EMISSION TOMOGRAPHY DRUGS; CURRENT GOOD MANUFACTURING 
PRACTICES

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

Unfunded Mandates: Undetermined

Legal Authority: PL 105-115, sec 121

CFR Citation: 21 CFR 220

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

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
_______________________________________________________________________




844. REPORTING INFORMATION REGARDING FALSIFICATION OF DATA

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

Unfunded Mandates: Undetermined

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

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

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            02/00/05

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

[[Page 37446]]

_______________________________________________________________________




845. 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.

Legal Authority: 21 USC 334(h)(1)(A); 21 USC 335a(b)(3); 21 USC 343(v); 
21 USC 350c(a) and (b); 21 USC 371; 21 USC 374(a)(1); 21 USC 381(j)(1) 
and (m)(2)(B)(ii); 21 USC 398(a)

CFR Citation: 21 CFR 1.3(c)

Legal Deadline: None

Abstract: The proposed rule would define the term ``serious adverse 
health consequences'' for purposes of the Public Health Security and 
Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism 
Act) and any implementing regulations. The term is used to describe 
part of the standard that is the basis for FDA to exercise certain 
authorities provided in sections 303, 304, 306, 307, 308, and 310 of 
title III (Protecting Safety and Security of the Food and Drug Supply), 
subtitle A (Protection of Food Supply), of the Bioterrorism Act.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            07/00/04

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected:  Businesses

Government Levels Affected: None

Agency Contact: Ms. Karen Carson, Deputy Director, Office of Plant and 
Dairy Foods and Beverages, Department of Health and Human Services, 
Food and Drug Administration, Center for Food Safety and Applied 
Nutrition, 5100 Paint Branch Parkway, Rm 3 A-001, College Park, MD 
20740
Phone: 301 436-1664
Fax: 301 436-2632
Email: [email protected]

John E. Kvenberg, Deputy Director, Office of Compliance (HFS-600), 
Department of Health and Human Services, Food and Drug Administration, 
HFS-10, Center for Food Safety and Applied Nutrition, 5100 Paint Branch 
Parkway, Rm 3B064, College Park, MD 20740
Phone: 301 436-2359
Fax: 301 436-2717
Email: [email protected]

RIN: 0910-AF06
_______________________________________________________________________




846. 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                            01/00/05

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
_______________________________________________________________________




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

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

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

CFR Citation: 21 CFR 165.110(b)

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

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

[[Page 37447]]

that such a regulation is not necessary to protect the public health.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            10/00/04
NPRM Comment Period End         12/00/04

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: Undetermined

Federalism:  Undetermined

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

RIN: 0910-AF10
_______________________________________________________________________




848. 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                            03/00/05

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
_______________________________________________________________________




849. COCHINEAL EXTRACT AND CARMINE LABEL DECLARATION

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

Legal Authority: 21 USC 379e(b)

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

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/00/04

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
_______________________________________________________________________




850. CHARGING FOR INVESTIGATIONAL DRUGS

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

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

CFR Citation: 21 CFR 312.7; 21 CFR 312.8

Legal Deadline: None

Abstract: The proposed rule would amend FDA's investigational new drug 
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                            12/00/04

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
_______________________________________________________________________




851. 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

[[Page 37448]]

312.420; 21 CFR 312.425; 21 CFR 312.430; 21 CFR 312.435

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/00/04

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
_______________________________________________________________________




852. PRESCRIPTION DRUG MARKETING ACT OF 1987; PRESCRIPTION DRUG 
AMENDMENTS OF 1992; POLICIES, REQUIREMENTS, AND ADMINISTRATIVE 
PROCEDURES; DERIVATIVES OF BLOOD

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

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

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

Legal Deadline: Other, Statutory, April 1, 2004, Effective date of 
final rule, 64 FR 67720, December 3, 1999.
Date final rule takes effect: ``Prescription Drug Marketing Act of 
1987; Prescription Drug Amendments of 1992; Policies, Requirements, and 
Administrative Procedures.''.

Abstract: FDA is proposing to amend the implementing regulation of the 
Prescription Drug Marketing Act of 1987, as modified by the 
Prescription Drug Amendments of 1992 and the FDA Modernization Act of 
1997. 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 derivatives of blood. The 
effective date of those provisions of that rule is December 1, 2006, as 
published on February 3, 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 derivatives of blood.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/00/05

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

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
_______________________________________________________________________




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

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

Unfunded Mandates: Undetermined

Legal Authority: 15 USC 402; 15 USC 409; 21 USC 321; 21 USC 331; 21 USC 
335; 21 USC 342; 21 USC 343; 21 USC 346a; 21 USC 348; 21 USC 351; 21 
USC 352; 21 USC 355; 21 USC 360b; 21 USC 361; 21 USC 362; 21 USC 371; 
21 USC 372; 21 USC 374; 42 USC 7671 et seq

CFR Citation: 21 CFR 2.125

Legal Deadline: None

Abstract: Under the Clean Air Act, the Food and Drug Administration 
(FDA) within the U.S. Department of Health and Human Services, in 
consultation with the Environmental Protection Agency, is required to 
determine whether an FDA-regulated product that releases an ozone-
depleting substance (ODS) is essential. The two agencies have 
tentatively determined that the two currently marketed non-ODS metered-
dose inhalers (MDIs) will be satisfactory alternatives to albuterol 
MDIs that contain ODS, and are proposing to remove the essential use 
designations for albuterol MDIs. If the essential use designation is 
removed, albuterol MDIs that contain an ODS could not be marketed after 
a suitable transition period. The proposed rule will specifically ask 
for comments on which phase-out period length will best ensure a smooth 
transition and minimize any adverse affects on the public health.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/16/04                    69 FR 33602
NPRM Comment Period End         08/16/04
Final Action                    03/00/05

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Federalism:  Undetermined

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]

RIN: 0910-AF18
_______________________________________________________________________




854.  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.

[[Page 37449]]

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 
Astreptococcus 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                            04/00/05
Direct Final Rule               04/00/05

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

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

RIN: 0910-AF20
_______________________________________________________________________




855.  LATEX CONDOMS: SPECIAL CONTROLS

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

Legal Authority: 21 USC 351; 21 USC 352; 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 provide detailed recommendations for labeling meeting 
the requirements of 21 CFR 801, that together with the general 
controls, provides a resaonable assurance of the safety and 
effectiveness of these devices. The rule will demonstrate how the 
agency is moving forward to meet the congressionaldirective of Public 
Law 106-554 that FDA review condom labeling to assure that the 
information regarding sexually transmitted disease transmission 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
_______________________________________________________________________




856.  BLOOD INITIATIVE--REGULATIONS FOR HUMAN BLOOD 
AND BLOOD COMPONENTS INTENDED FOR TRANSFUSION OR FOR FURTHER 
MANUFACTURING USE

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

Legal Authority: 21 USC 321; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 
21 USC 360; . . .

CFR Citation: 21 CFR 600; 21 CFR 601; 21 CFR 606; 21 CFR 607; 21 CFR 
610; . . .

Legal Deadline: None

Abstract: In multiple rulemakings, the Food and Drug Administration 
(FDA) is amending the biologics regulations by removing, revising, or 
updating specific regulations applicable to blood, blood components, 
Source Plasma, and blood-derivative products to be more consistent with 
current practices and to remove unnecessary or outdated requirements. 
This action is based on FDA's comprehensive review of the biologics 
regulations. It is also based on reports by the U.S. House of 
Representatives Committee on Government Reform and Oversight 
Subcommittee on House Resources and Intergovernmental Relations, the 
General Accounting Office, and the Institute of Medicine, as well as on 
public comments. The other remaining subject intended to be addressed 
in the rulemakings include: labeling of blood and blood components 
(0910-AF26). These actions are intended to help ensure the continued 
safety of the Nation's blood supply.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            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-AF25
_______________________________________________________________________




857.  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 360b; 21 USC 361; 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.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM (Amendment)                09/00/04

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Gerald M. Rachanow, Regulatory Counsel, Division of

[[Page 37450]]

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

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




858.  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 360b; 21 USC 361; 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.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM (Amendment)                09/00/04

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, Rockville, MD 20857
Phone: 301 827-2241
Fax: 301 827-2315
Email: [email protected]

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




859.  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; 21USC 371a; 21 USC 331; 21 USC 360; 21 USC 360b; 21 USC 361; 21 
USC 371

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM (Phenylephrine Bitartrate) 09/00/04
NPRM (Phenyl-propanolamine)     09/00/04
NPRM (Amendment) (Sinusitis 
Claim)                          10/00/04

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, Rockville, MD 20857
Phone: 301 827-2241
Fax: 301 827-2315
Email: [email protected]

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




860.  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 360b; 21 USC 361; 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.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM (Amendment) (Labeling)     08/00/04
NPRM (Amendment) (Pediatric)    09/00/04

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, Rockville, MD 20857
Phone: 301 827-2241
Fax: 301 827-2315
Email: [email protected]

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




861.  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 360b; 21 USC 361; 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.

[[Page 37451]]

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM (Convenience Sizes)        08/00/04

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, Rockville, MD 20857
Phone: 301 827-2241
Fax: 301 827-2315
Email: [email protected]

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




862.  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; 21USC 371a; 21 USC 331; 21 USC 360; 21 USC 360b; 21 USC 361; 21 
USC 371

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM (Phenyl-propanolamine)     09/00/04

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, Rockville, MD 20857
Phone: 301 827-2241
Fax: 301 827-2315
Email: [email protected]

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


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


Food and Drug Administration (FDA)



_______________________________________________________________________




863. 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                    09/00/04

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
_______________________________________________________________________




864. LABELING FOR HUMAN PRESCRIPTION DRUGS; REVISED FORMAT

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

Legal Authority: 21 USC 321; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 
21 USC 358; 21 USC 360; 21 USC 360b; 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

Legal Deadline: None

Abstract: This regulation is one component of the Secretary's 
initiative to reduce medical errors. The regulation would amend the 
regulations governing the format and content of professional labeling 
for human

[[Page 37452]]

prescription drug and biologic products, 21 C.F.R. 201.56 and 201.57. 
The regulation would require that professional labeling include a 
section containing highlights of prescribing information, and a section 
containing an index to prescribing information; reorder currently 
required information and make minor changes to its content, and 
establish minimum graphical requirements for professional labeling.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/22/00                    65 FR 81082
NPRM Comment Period End         03/22/01
NPRM Comment Period Reopened    03/30/01
NPRM Comment Period Reopening 
End                             06/22/01
Final Action                    10/00/04

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: Undetermined

Federalism:  Undetermined

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

RIN: 0910-AA94
_______________________________________________________________________




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

Priority: Other Significant

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

CFR Citation: 21 CFR 1270; 21 CFR 1271

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            01/08/01                     66 FR 1508
NPRM Comment Period End         05/08/01
Final Action                    12/00/04

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: State

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

RIN: 0910-AB28
_______________________________________________________________________




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

Priority: Economically Significant. Major under 5 USC 801.

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

CFR Citation: 21 CFR 606; 21 CFR 610

Legal Deadline: None

Abstract: This rulemaking is one of a number of actions being taken to 
amend the biologics regulations to remove, revise, or update the 
regulations applicable to blood, blood components, and blood 
derivatives. These actions are based on FDA's comprehensive review of 
the biologics regulations and on reports by the U.S. House of 
Representatives Committee on Government Reform and Oversight's, 
Subcommittee on House Resources and Intergovernmental Relations, the 
General Accounting Office, and the Institute ofMedicine, as well as on 
public comments. In this rulemaking, FDA will amend the biologics 
regulations to require that blood establishments prepare and follow 
written procedures for appropriate action when it is determined that 
blood and blood components pose an increased risk for transmitting 
hepatitis C virus (HCV) infection because they have been collected from 
a donor who, at a later date, tested reactive for evidence of HCV. The 
HIV lookback regulations will be amended for consistency.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            11/16/00                    65 FR 69377
NPRM Comment Period End         02/14/01
Final Action                    11/00/04

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




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

Priority: Economically Significant. Major under 5 USC 801.

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

Legal Authority: 21 USC 321; 21 USC 342; 21 USC 343; 21 USC 348; 21 USC 
371; 21 USC 374; 21 USC 381; 21 USC 393; 42 USC 264

CFR Citation: 21 CFR 111

Legal Deadline: None

Abstract: The Food and Drug Administration proposed in the Federal 
Register of March 13, 2003 (68 FR

[[Page 37453]]

12158), current good manufacturing practice (CGMP) regulations for 
dietary ingredients and dietary supplements. The proposed rule was 
published to establish the minimum CGMPs necessary to ensure that, if 
firms engage in activities related to manufacturing, packaging, or 
holding dietary ingredients of dietary supplements, they do so in a 
manner that will not adulterate and misbrand such dietary ingredientsor 
dietary supplements. FDA also proposed to require manufacturers to 
evaluate the identity, purity, quality, strength, and composition of 
their dietary ingredients and dietary supplements. The proposed rule 
also responds to concerns that such regulations are necessary to ensure 
that consumers are provided with dietary supplement products which have 
not been adulterated as a result of manufacturing, packing, or holding, 
e.g., which have the identity and provide the quantity of dietary 
ingredients declared in labeling.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

ANPRM                           02/06/97                     62 FR 5700
ANPRM Comment Period End        06/06/97
NPRM                            03/13/03                    68 FR 12157
NPRM Comment Period End         08/11/03
Final Action                    11/00/04

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: Undetermined

Federalism:  Undetermined

Agency Contact: Linda Kahl, Consumer Safety Officer, Department of 
Health and Human Services, Food and Drug Administration, HFS-206, 
Center for Food Safety and Applied Nutrition, 5100 Paint Branch 
Parkway, College Park, MD 20740
Phone: 202 418-3101
Fax: 202 418-3131
Email: [email protected]

RIN: 0910-AB88
_______________________________________________________________________




868. 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                    11/00/04

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
_______________________________________________________________________




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

Priority: Substantive, Nonsignificant

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

CFR Citation: 21 CFR 800.20

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            03/31/03                    68 FR 15404
NPRM Comment Period End         06/30/03
Final Rule                      12/00/04

Regulatory Flexibility Analysis Required: No

Government Levels Affected: Undetermined

Federalism:  Undetermined

Agency Contact: Joseph M. Sheehan, Chief, Regulations Staff, Department 
of Health and Human Services, Food and Drug Administration, HFZ-215, 
Center for Devices and Radiological Health, HFZ-215, 1350 Piccard 
Drive, Rockville, MD 20850
Phone: 301 827-2974
Fax: 301 594-4765
Email: [email protected]

RIN: 0910-AC32
_______________________________________________________________________




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

Priority: Substantive, Nonsignificant

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

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

Legal Deadline: None

Abstract: This rule amends the performance standard for diagnostic x-
ray systems and their components in 21 CFR 1020.30, 1020.31, 1020.32, 
and 1020.33 to address the changes in technology and practice.

[[Page 37454]]

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/10/02                    67 FR 76056
Final Action                    06/00/04

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
_______________________________________________________________________




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

Priority: Economically Significant. Major under 5 USC 801.

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

Legal Authority: PL 107-188, sec 306

CFR Citation: 21 CFR 1

Legal Deadline: None

Abstract: This rulemaking is one of a number of actions being taken to 
improve FDA's ability to respond to threats of bioterrorism. Section 
414(b) of the Federal Food, Drug and Cosmetic Act (FFDCA), which was 
added by section 306 of the Public Health Security and Bioterrorism 
Preparedness and Response Act of 2002 (the Act), authorizes the 
Secretary, through FDA, to promulgate final regulations by December 12, 
2003. The Act authorizes regulations that require the establishment and 
maintenance of records, for not longer than two years, that would allow 
the Secretary to identify the immediate previous sources and the 
immediate subsequent recipients of food, including its packaging. The 
required records would be those that are needed by FDA in order to 
address credible threats of serious adverse health consequences or 
death to humans or animals. Specific covered entities are those that 
manufacture, process, pack, transport, distribute, receive, hold, or 
import food. Farms and restaurants are excluded. The Secretary is 
directed to take into account the size of a business in promulgating 
these regulations. Section 306 of the Act also added section 414(a) and 
amended section 704(a) of FFDCA to permit FDA to inspect these records 
and other information if the Secretary has a reasonable belief that an 
article of food is adulterated and presents a threat of serious adverse 
health consequences or death to humans or animals.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            05/09/03                    68 FR 25188
NPRM Comment Period End         07/08/03
Final Action                    07/00/04

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: None

URL For More Information:
www.fda.gov/oc/bioterrorism/bioact.html

URL For Public Comments:
www.fda.gov/ohrms/dockets/02n0277/02n0277.htm

Agency Contact: Nega Beru, Supervisory Chemist, Office of Plant, Dairy 
Foods and Beverages, Department of Health and Human Services, Food and 
Drug Administration, HFS-305, Center for Food Safety and Applied 
Nutrition, 5100 Paint Branch Parkway, College Park, MD 20740
Phone: 301 436-1400
Fax: 301 436-2651
Email: [email protected]

RIN: 0910-AC39
_______________________________________________________________________




872. REGISTRATION OF FOOD AND ANIMAL FEED FACILITIES

Priority: Economically Significant. Major under 5 USC 801.

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

Legal Authority: PL 107-188, sec 305

CFR Citation: 21 CFR 1

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

Abstract: This rulemaking is one of a number of actions being taken to 
improve FDA's ability to respond to threats of bioterrorism and other 
foodborne illness emergencies. Section 415 of the Federal Food, Drug, 
and Cosmetic Act (FFDCA), which was added by section 305 of the Public 
Health Security and Bioterrorism Preparedness and Response Act of 2002 
(the Bioterrorism Act), directs the Secretary to require facilities 
engaged in manufacturing, processing, packing, or holding of food for 
consumption in theUnited States to be registered with the Secretary. 
Section 415 directs the Secretary, to promulgate final regulations 
implementing the requirements by December 12, 2003. The owner, 
operator, or agent in charge of the facility must submit the 
registration. Foreign facilities must include the name of the United 
States agent for the facility. The registration must include the name 
and address of each facility at which, and all trade names under which, 
the registrant conducts business. If the Secretary determines it is 
necessary through guidance, the registration must include the general 
food category (as identified under 21 CFR 170.3) of foods manufactured, 
processed, packed, or held at the facility. The registrant is required 
to notify the Secretary of changes to the information contained in the 
registration in a timely manner. Under the interim final rule (IFR) 
published on October 10, 2003 (68 FR 58894), upon receipt of the 
completed registration form, FDA will notify the registrant of receipt 
of the registration and assign a unique registration number to the 
facility. Section 415 requires the Secretary to compile and maintain an 
up-to-date list of registered facilities. This list and any 
registration documents submitted to the Secretary are not subject to 
disclosure under the Freedom of Information Act. For purposes of 
section 415, ``facility'' includes any factory, warehouse, or 
establishment engaged in the manufacturing, processing, packing, or 
holding of food. Exempt from the registration requirement are farms, 
restaurants, other retail food

[[Page 37455]]

establishments, nonprofit food establishments in which food is prepared 
for or served directly to the consumer, and fishing vessels (except 
those engaged in processing as defined in 21 CFR 123.3(k)). Foreign 
facilities required to register include only those from which food is 
exported to the United States without further processing or packaging 
outside the United States. The Bioterrorism Act provides that if food 
from an unregistered foreign facility is offered for import into the 
United States without having registered, the food will be held at the 
port of entry or at a secure facility, until the foreign facility has 
registered. On April 14, 2004, FDA issued a notice reopening for 30 
days, on a limited range of issues, the comment period on the IFR. FDA 
took this action consistent with its statement in the IFR that it would 
reopen the comment period for 30 days in order to ensure that those 
commenting on the IFRhave had the benefit of FDA's outreach and 
educational efforts and have had experience with the systems, 
timeframes, and data elements of the registration system.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            02/03/03                     68 FR 5377
Interim Final Rule              10/10/03                    68 FR 58894
Interim Final Rule Comment 
Period Reopened                 04/14/04                    69 FR 19766
Interim Final Rule Comment 
Period Reopened End             05/14/04
Final Rule                      03/00/05

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: None

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

RIN: 0910-AC40
_______________________________________________________________________




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

Priority: Economically Significant. Major under 5 USC 801.

Legal Authority: PL 107-188, sec 307

CFR Citation: 21 CFR 1.276 et seq

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

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            02/03/03                     68 FR 5428
Interim Final Rule              10/10/03                    68 FR 58974
Interim Final Rule Comment 
Period Reopened                 04/14/04                    69 FR 19763
Interim Final Rule Comment 
Period Reopened End             06/14/04
Final Rule                      03/00/05

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: Federal

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

RIN: 0910-AC41
_______________________________________________________________________




874. PRESUBMISSION CONFERENCES

Priority: Substantive, Nonsignificant

Legal Authority: 21 USC 360b

CFR Citation: 21 CFR 514

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            08/25/00                    65 FR 51782
Final Action                    08/00/04

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Federalism:  Undetermined

Agency Contact: Gail Schmerfeld, Special Assistant, Department of 
Health

[[Page 37456]]

and Human Services, Food and Drug Administration, HFV-100, Center for 
Veterinary Medicine, 7500 Standish Place, Rockville, MD 20855
Phone: 301 827-0205

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




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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            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
_______________________________________________________________________




876.  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 331; 21 USC 351 to 353; 21 USC 355; 
21 USC 360; . . .

CFR Citation: 21 CFR 600; 21 CFR 601; 21 CFR 606; 21 CFR 607; 21 CFR 
610; . . .

Legal Deadline: None

Abstract: In multiple rulemakings, the Food and Drug Administration 
(FDA) is amending the biologics regulations by removing, revising, or 
updating specific regulations applicable to blood, blood components, 
Source Plasma, and blood-derivative products to be more consistent with 
current practices and to remove unnecessary or outdated requirements. 
This action is based on FDA's comprehensive review of the biologics 
regulations. It is also based on reports by the U.S. House of 
Representatives Committee on Government Reform and Oversight 
Subcommittee on House Resources and Intergovernmental Relations, the 
General Accounting Office, and the Institute of Medicine, as well as on 
public comments. The other remaining subject intended to be addressed 
in the rulemakings include: donor eligibility requirements (0910-AF25). 
These actions are intended to help ensure the continued safety of the 
Nation's blood supply.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Action                    06/00/05

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Sharon Carayiannis, Consumer Safety Officer, Department 
of Health and Human Services, Food and Drug Administration, Suite 400S 
(HFM-17), Center for Biologics Evaluation and Research, 1401 Rockville 
Pike, Rockville, MD 20852-1448
Phone: 301 827-6210

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




877.  OVER-THE-COUNTER (OTC) DRUG REVIEW--
ANTIPERSPIRANT 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 360b; 21 USC 361; 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.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Action (Partial Stay)     09/00/04

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, Rockville, MD 20857
Phone: 301 827-2241
Fax: 301 827-2315
Email: [email protected]

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

[[Page 37457]]

_______________________________________________________________________




878.  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 360b; 21 USC 361; 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.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Action (Amendment) (Common 
Cold)                           10/00/04

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, Rockville, MD 20857
Phone: 301 827-2241
Fax: 301 827-2315
Email: [email protected]

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




879.  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; 21USC 371a; 21 USC 331; 21 USC 360; 21 USC 360b; 21 USC 361; 21 
USC 371

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Action (Emergency First 
Aid Eyewashes)                  11/00/04

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, Rockville, MD 20857
Phone: 301 827-2241
Fax: 301 827-2315
Email: [email protected]

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




880.  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; 21USC 371a; 21 USC 331; 21 USC 360; 21 USC 360b; 21 USC 361; 21 
USC 371

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Action (Technical 
Amendments)                     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, Rockville, MD 20857
Phone: 301 827-2241
Fax: 301 827-2315
Email: [email protected]

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




881.  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; 21USC 371a; 21 USC 331; 21 USC 360; 21 USC 360b; 21 USC 361; 21 
USC 371

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Action (Warnings)         11/00/04

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, Rockville, MD 20857
Phone: 301 827-2241
Fax: 301 827-2315
Email: [email protected]

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

[[Page 37458]]

_______________________________________________________________________


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


Food and Drug Administration (FDA)



_______________________________________________________________________




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

Priority: Routine and Frequent

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

CFR Citation: 21 CFR 59

Legal Deadline: None

Abstract: The proposed rule would establish requirements for importers 
and other persons who use sampling services and private laboratories in 
connection with imported food. For example, the proposal would pertain 
to persons who use sample collection services and private laboratories, 
and would describe some responsibilities for such persons, sample 
collection services, and private laboratories. These responsibilities 
would include recordkeeping requirements to ensure that the correct 
sample is collectedand analyzed, and a notification requirement if a 
person intends to use a sampling service or a private laboratory in 
connection with imported food. The proposed rule is intended to help 
insure the integrity and scientific validity of data and results 
submitted to FDA.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

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

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

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

RIN: 0910-AB96
_______________________________________________________________________




883. 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, College Park, MD 20740
Phone: 301 436-1486
Fax: 301 436-2632
Email: [email protected]

RIN: 0910-AC21
_______________________________________________________________________




884. REQUIREMENTS FOR SUBMISSION OF IN VIVO BIOEQUIVALENCE DATA

Priority: Substantive, Nonsignificant

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

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

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            10/29/03                    68 FR 61640


Next Action Undetermined

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

[[Page 37459]]

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
_______________________________________________________________________




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

Priority: Other Significant

Legal Authority: 21 USC 355b

CFR Citation: 21 CFR 201; 21 CFR 208; 21 CFR 209

Legal Deadline: Final, Statutory, January 4, 2003.

Abstract: To require the labeling of human drugs approved under section 
505 of the Federal Food, Drug, and Cosmetic Act to include a toll-free 
number for reports of adverse events, and a statement that the number 
is to be used for reporting purposes only and not to receive medical 
advice.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            04/22/04                    69 FR 21778
Final Action                     To Be                       Determined

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

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-AC35
_______________________________________________________________________




886. 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
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
_______________________________________________________________________




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

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

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

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

Legal Deadline: None

Abstract: The Food and Drug Administration (FDA) is proposing to amend 
the regulations governing the format in which clinical study data (CSD) 
are required to be submitted for new drug applications (NDAs), 
biological license applications (BLAs), and abbreviated new drug 
applications (ANDAs). The proposal would revise our regulations to 
require 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

________________________________________________________________________


Next Action Undetermined

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

[[Page 37460]]

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
_______________________________________________________________________




888. 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                             To Be                       Determined

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
_______________________________________________________________________




889. FOOD LABELING: FOOD ALLERGEN INGREDIENT LABELING

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

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

CFR Citation: 21 CFR 101

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                             To Be                       Determined

Regulatory Flexibility Analysis Required: Yes

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
_______________________________________________________________________




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

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

Unfunded Mandates: Undetermined

Legal Authority: 21 USC 351

CFR Citation: 21 CFR 211.122

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

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

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected:  Businesses

Government Levels Affected: None

[[Page 37461]]

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
_______________________________________________________________________




891. CURRENT GOOD MANUFACUTRING 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 onAugust 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
_______________________________________________________________________




892. INFANT FORMULA QUALITY FACTORS

Priority: Other Significant

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

CFR Citation: 21 CFR 106; 21 CFR 107

Legal Deadline: None

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




893.  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 360b; 21 USC 361; 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.

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, Rockville, MD 20857
Phone: 301 827-2241
Fax: 301 827-2315
Email: [email protected]

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




894.  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 360b; 21 USC 361; 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.

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

[[Page 37462]]

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

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




895.  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; 21USC 371a; 21 USC 331; 21 USC 360; 21 USC 360b; 21 USC 361; 21 
USC 371

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

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, Rockville, MD 20857
Phone: 301 827-2241
Fax: 301 827-2315
Email: [email protected]

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


Department of Health and Human Services (HHS)         Completed Actions


Food and Drug Administration (FDA)



_______________________________________________________________________




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

Priority: Routine and Frequent

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

CFR Citation: 21 CFR 201; 21 CFR 310; 21 CFR 330 to 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.
SMALL ENTITIES AFFECTED: The effects, if any, vary depending on the 
individual rulemaking. However, the Agency anticipates that the rules 
would not have a significant economic impact on a substantial number of 
small entities as defined by the Regulatory Flexibility Act.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Actions Will Continue Under 
Separate Rulemakings            06/08/04
Anorectal Products (0910-AC65)  Final Action (Amendment) 08/26/03 (68 
FR 51167)

Antidiarrheal Products (0910-AC82)  NPRM (Amendment) (Trav. Diar) 04/
17/03 (68 FR 18915)  Merged With 0910-AF29 06/08/04

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

Antiperspirant Products (0910-AC89)  Final Action 06/09/03 (68 FR 
34273)  Final Action (Partial Stay) Merged With 0910-AF30 06/08/04

Cough/Cold (Antihistamine) Products (0910-AD31)  Merged With 0910-AF31 
06/08/04

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

Cough/Cold (Bronchodilator) Products (0910-AD33)  Merged With 0910-AF32 
06/08/04

Cough/Cold (Combination) Products (0910-AD25)  Final Action 12/23/02 
(67 FR 78158)   NPRM (Amendment) Merged With 0910-AF33 06/08/04

Cough/Cold (Nasal Decongestant) Products (0910-AD43)  Merged With 0910-
AF34 06/08/04

External Analgesic Products (0910-AD06)  Final Action 
(Amendment)(Warning) 12/06/02 (67 FR 72555)  NPRM (Amendment)(Patches) 
07/17/03 (68 FR 42324)  Merged With 0910-AF35 06/08/04

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

Internal Analgesic Products (0910-AD07)  NPRM (Amendment)(Ibuprofen) 
08/21/02 (67 FR 54139)  Merged With 0910-AF36 06/08/04

Labeling of Drug Products for OTC Human Use (0910-AD47)  NPRM (Sodium 
Labeling) 03/24/04 (69 FR 13765)  Final Action (Sodium Labeling) 03/24/
04 (69 FR 13717)  Final Action (Ca/Mg/K/Na) 03/24/04 (69 FR 13725)

Laxative Drug Products (0910-AC85)  NPRM (Amendment) (Psyllium Granular 
Dosage Form) 08/05/03 (68 FR 46133)  Merged With 0910-AF38 06/08/04

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

Ophthalmic Products (0910-AC72)  NPRM (Emergency First Aid Eyewashes) 
02/19/03 (68 FR 7951)  Final Action (Technical Amendment) 02/19/03 (68 
FR 7919)  Final Action (Name Change) 06/03/03 (68 FR 32981)  Final 
Action (Emerg. First Aid Eyewashes) Merged With 0910-AF39 06/08/04

Oral Health Care Products (0910-AC98)  ANPRM (Plaque/Gingivitis) 05/29/
03 (68 FR 32232)  Merged With 0910-AF40 06/08/04

Pediculicide Products (0910-AC79)  NPRM (Labeling Amendment) 05/10/02 
(67 FR 31739)  Final Action (Labeling Amendment) 12/31/03 (68 FR 75414)

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

[[Page 37463]]

Skin Protectant Products (0910-AC96)  Final Action 06/04/03 (68 FR 
33362)  NPRM (Astringent) 06/13/03 (68 FR 35346)  Final Action 
(Astringent) 06/13/03 (68 FR 35290)  Final Action (Astringent) (Confirm 
Effective Date) 10/09/03 (68 FR 58273)  Final Action (Technical 
Amendment) 12/09/03 (68 FR 68509)  Final Action (Technical Amendment) 
Merged With 0910-AF42 06/08/04

Sunscreen Products (0910-AC68)  Final Action (Names) 06/20/02 (67 FR 
41821)  ANPRM (Bug and Insect Repellent) and NPRM (UVA/UVB) Merged With 
0910-AF43 06/08/04

Vaginal Contraceptive Products (0910-AD19)  NPRM (Amendment) 01/16/03 
(68 FR 2254)  Merged With 0910-AF44 06/08/04

Weight Control Products (0910-AC93)  Merged With 0910-AF45 06/08/04

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, Rockville, MD 20857
Phone: 301 827-2241
Fax: 301 827-2315
Email: [email protected]

RIN: 0910-AA01
_______________________________________________________________________




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

Priority: Other Significant

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

CFR Citation: 21 CFR 106; 21 CFR 107

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Actions Will Continue Under 
Separate Rulemakings            06/04/04
Current Good Mfg. Practices; Qual. Control Proc.; Quality Factors 
(0910-AD81)  NPRM 07/09/96 (61 FR 36154)  NPRM Comment Period End 12/
06/96  NPRM Comment Period Reopened 04/28/03 (68 FR 22341)  NPRM 
Comment Period Extended 06/27/03 (68 FR 38247)  NPRM Comment Period End 
08/26/03  Merged With 0910-AF27 06/04/04

Infant Form Cons Comp, Micro Test & Recd Retention Req (0910-
AD80)  NPRM 01/26/89 (54 FR 3783)  NPRM Comment Period End 03/27/
89  Final Rule 12/24/91 (56 FR 66566)

Infant Formula Quality Factors (0910-AD77)  NPRM Comment Period End 12/
06/96  NPRM Comment Period Reopened 04/28/03 (68 FR 22341)  NPRM 
Comment Period Extended 06/27/03 (68 FR 38247)  NPRM Comment Period End 
08/26/03  Merged With 0910-AF28 06/04/04

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]

RIN: 0910-AA04
_______________________________________________________________________




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

Priority: Other Significant

CFR Citation: 21 CFR 50; 21 CFR 312

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn                       06/10/04

Regulatory Flexibility Analysis Required: No

Government Levels Affected: Federal

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

RIN: 0910-AA89
_______________________________________________________________________




899. BLOOD INITIATIVE

Priority: Other Significant

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

CFR Citation: 21 CFR 600; 21 CFR 601; 21 CFR 606; 21 CFR 607; 21 CFR 
610; 21 CFR 630; 21 CFR 640; 21 CFR 660; 21 CFR 680

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Actions Will Continue Under 
Separate Rulemakings            06/04/04
Albumin (Human), Plasma Protein Fraction (Human) and Immune Globulin 
(Human); Revision of Requirements (0910-AE95)  NPRM 05/14/99 (64 FR 
26344)  Direct Final Rule 05/14/99 (64 FR 26282)  Direct Final Rule - 
Confirmation in Part and Technical Amendment 03/14/00 (65 FR 
13678)  Final Action 08/28/00 (65 FR 52016)

[[Page 37464]]

General Requirements for Blood, Blood Components, and Plasma 
Derivatives; Notification of Deferred Donors (0910-AE99)  NPRM 08/19/99 
(64 FR 45355)  Final Action 06/11/01 (66 FR 31165)

Plasma Derivatives and Similar Recombinant-Based Products; Requirements 
for Notification of Recalls and Withdrawals (0910-AF02)  ANPRM 08/19/99 
(64 FR 45383)  Withdrawn 06/04/04

Regulations for Human Blood and Blood Components Intended for 
Transfusion or for Further Manufacturing Use (0910-AF00)  Merged With 
0910-AF25 06/04/04

Requirements for Testing Human Blood Donors for Evidence of Infection 
Due to Communicable Disease Agents (0910-AE98)  NPRM 08/19/99 (64 FR 
45340)  Final Action 06/11/01 (66 FR 31146)

Revisions to Labeling and Storage Requirements for Blood and Blood 
Components, Including Source Plasma (0910-AE96)  NPRM 07/30/03 (68 FR 
44678)  Correction Notice 10/27/03 (68 FR 61172)  NPRM Comment Period 
End 10/30/03  Merged With 0910-AF26 06/04/04

Revisions to the Requirements Applicable to Blood, Blood Components, 
and Source Plasma (0910-AE89)  NPRM 08/19/99 (64 FR 45375)  Direct 
Final Rule 08/19/99 (64 FR 45366)  Direct Final Rule - Confirmation in 
Part and Technical Amendment 01/10/01 (66 FR 1834)  Final Action 08/06/
01 (66 FR 40886)

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: None

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

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




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

Priority: Other Significant

CFR Citation: 21 CFR 210.1(c); 21 CFR 210.2(a); 21 CFR 210.2(b); 21 CFR 
211.1(b); 21 CFR 820.1(a)(1); 21 CFR 820.1(c); 21 CFR 1271

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    05/24/04                    69 FR 29786

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: State

Agency Contact: Paula S. McKeever
Phone: 301 827-6210
Fax: 301 827-9434

RIN: 0910-AB27
_______________________________________________________________________




901. SUPPLEMENTS AND OTHER CHANGES TO AN APPROVED APPLICATION

Priority: Other Significant

CFR Citation: 21 CFR 314

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    04/08/04                    69 FR 18728

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Howard P. Muller
Phone: 301 594-2041
Fax: 301 827-5562
Email: [email protected]

RIN: 0910-AB61
_______________________________________________________________________




902. CURRENT GOOD MANUFACTURING PRACTICE FOR MEDICATED FEEDS

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

CFR Citation: 21 CFR 225

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn                       05/19/04

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Federalism:  Undetermined

Agency Contact: George Graber
Phone: 301 827-6651
Email: [email protected]

RIN: 0910-AB70
_______________________________________________________________________




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

Priority: Other Significant

CFR Citation: 21 CFR 314; 21 CFR 601

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    12/11/03                    68 FR 69009

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: Federal

Agency Contact: Nicole K. Mueller
Phone: 301 594-2041
Fax: 301 594-6197
Email: [email protected]

RIN: 0910-AB91
_______________________________________________________________________




904. USE OF MATERIALS DERIVED FROM BOVINE AND OVINE ANIMALS IN FDA-
REGULATED PRODUCTS

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

CFR Citation: Not Yet Determined

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn                       05/19/04

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Federalism:  Undetermined

Agency Contact: Rebecca Buckner
Phone: 301 436-1486
Fax: 301 436-2632
Email: [email protected]

RIN: 0910-AC19
_______________________________________________________________________




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

Priority: Economically Significant. Major under 5 USC 801.

CFR Citation: 21 CFR 201.25; 21 CFR 601.67

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Rule                      02/26/04                     69 FR 9119

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: None

[[Page 37465]]

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

RIN: 0910-AC26
_______________________________________________________________________




906. ADMINISTRATIVE DETENTION OF FOOD FOR HUMAN OR ANIMAL CONSUMPTION 
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; 21 CFR 10.45(d); 21 CFR 16.1(b)(1)

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    06/04/04                    69 FR 31660

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Kelli Giannattasio
Phone: 301 436-1432
Fax: 301-436-2639
Email: [email protected]

RIN: 0910-AC38
_______________________________________________________________________




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

Priority: Substantive, Nonsignificant

CFR Citation: 21 CFR 558.5; 21 CFR 510.455

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    05/27/04                    69 FR 30194

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Deaman Momailovic
Phone: 301 827-6652
Fax: 301 594-4512

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




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

Priority: Substantive, Nonsignificant

CFR Citation: 21 CFR 201.59; 21 CFR 610.21

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    01/05/04                      69 FR 255

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Astrid L. Szeto
Phone: 301 827-6210
Fax: 301 827-9434

RIN: 0910-AC56
_______________________________________________________________________




909. REVISION OF THE REQUIREMENTS FOR SPORE-FORMING MICROORGANISMS

Priority: Other Significant

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

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

NPRM-Companion to Direct Final 
Rule                            12/30/03                    68 FR 75179
Direct Final Rule               12/30/03                    68 FR 75116
Confirmation of Effective Date  05/14/04                    69 FR 26768

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Valerie Butler
Phone: 301 827-6210
Fax: 301 827-9434

RIN: 0910-AC57
_______________________________________________________________________




910. CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKING, OR 
HOLDING HUMAN FOOD (PART 110) (COMPLETION OF A SECTION 610 REVIEW)

Priority: Other Significant

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

CFR Citation: 21 CFR 110

Legal Deadline: None

Abstract: Part 110 (21 CFR part 110) describes regulations for current 
good manufacturing practice in manufacturing, packing, and holding 
human food. Part 110 contains regulations describing sanitary practices 
for personnel, buildings and facilities, and equipment. It also 
includes regulations on production and process controls for 
manufacturing practices and on defect action levels for natural or 
unavoidable defects in food for human use that present no health 
hazard. FDA is undertaking a review of part110 under section 610 of the 
Regulatory Flexibility Act. The purpose of this review is to determine 
whether the regulations in part 110 should be continued without change, 
or whether they should be amended or rescinded, consistent with the 
stated objectives of applicable statutes, to minimize adverse impacts 
on a substantial number of small entities. FDA will consider, and is 
soliciting comments on, the following: (1) the continued need for the 
regulations in part 110; (2) the nature of complaints or comments 
received concerning the regulations in part 110; (3) the complexity of 
the regulations in part 110; (4) the extent to which the regulations in 
part 110 overlap, duplicate, or conflict with other Federal, State, or 
governmental rules; and (5) the degree to which technology, economic 
conditions, or other factors have changed in the area affected by the 
regulations in part 110.
The section 610 review will be carried out along with a regulatory 
review under section 5 of Executive Order 12866, which calls for 
agencies to periodically review existing regulations to determine 
whether any should be modified or eliminated so as to make the agency's 
regulatory program more effective in achieving its goals, less 
burdensome, or in greater alignment with the President's priorities and 
the princples set forth in the Executive order. The combined effect of 
the two reviews will be to determine if it is possible to redesign 
current good manufacturing practices in ways that will maintain or 
increase the effectiveness of preventive and sanitary controls, and, at 
the same time, reduce compliance and other costs associated with the 
regulations.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Begin Review                    05/01/03
End Review                      12/31/03

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Richard A. Williams, Director, Division of Market 
Studies, Department of Health and Human Services, Food and Drug 
Administration, HFS-725, Center for Food Safety and Applied Nutrition,

[[Page 37466]]

5100 Paint Branch Parkway, College Park, MD 20740
Phone: 301 436-1989
Fax: 301 436-2626
Email: [email protected]

RIN: 0910-AC58
_______________________________________________________________________




911.  OVER-THE-COUNTER (OTC) DRUG REVIEW--
ANTIDIARRHEAL 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 360b; 21 USC 361; 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.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Action (Amendment) (Trav. 
Diar)                           05/12/04                    69 FR 26301

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: None

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

Related RIN: Split from 0910-AA01
RIN: 0910-AF29
_______________________________________________________________________


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


Health Resources and Services Administration (HRSA)



_______________________________________________________________________




912. 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 careservices upon which the actions or claims were based. 
The purpose of this NPRM is to prevent the evasion of the medical 
malpractice payment reporting requirement of the Data Bank through the 
agreement of the parties to a lawsuit to use the corporate health care 
entity to ``shield'' practitioners. It would also require malpractice 
payers, in very limited circumstances, when it is impossible to 
identify the practitioner who furnished or failed to furnish the health 
care services upon which the actions or claims were based, to report 
why the practitioner could not be identified, and to provide the name 
of the corporate health care entity.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

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

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

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

RIN: 0906-AA41
_______________________________________________________________________




913. 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                     09/00/04

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

[[Page 37467]]

_______________________________________________________________________




914.  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 ofthe 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                            09/00/04

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, Mail Stop 16C-17, Parklawn Bldg., 
Rockville, MD 20857
Phone: 202 690-8476
Email: [email protected]

RIN: 0906-AA62
_______________________________________________________________________




915.  NOTICE OF PROPOSED RULEMAKING TO AMEND THE FINAL 
RULE 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, 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:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/00/04

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
_______________________________________________________________________




916.  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                            09/00/04

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
_______________________________________________________________________




917.  LIABILITY PROTECTION FOR CERTAIN FREE CLINIC 
HEALTH PROFESSIONALS

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

Legal Authority: 42 USC 233(o); PL 108-199, title II

CFR Citation: Not Yet Determined

Legal Deadline: None

Abstract: This notice of proposed rulemaking (NPRM) provides 
information on the implementation of 42 U.S.C. 233(o), which makes

[[Page 37468]]

available medical malpractice liability protection for certain 
volunteer health professionals in free clinics. This is accomplished by 
deeming eligible volunteers to be employees of the Public Health 
Service and, thereby, protected by the Federal Tort Claims Act (FTCA). 
The NPRM provides information whereby en entity or person can determine 
when and the extent to which a volunteer health professional at a free 
clinic is deeemed to be a Public Health Service Employee and, 
therefore, afforded the protections of the FTCA.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/00/04

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Dr. Felicia Collins, Branch Chief, Clinical Quality 
Systems Branch HRSA/BPHC/ Division of Clinical Quality, Department of 
Health and Human Services, Health Resources and Services 
Administration, 4350 East West Hwy, Bethesda, MD 20814
Phone: 301 594-0818
Fax: 301 594 5224

RIN: 0906-AA67
_______________________________________________________________________




918.  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 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 that 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                            09/00/04

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Thom E. Balbier Jr., Director, Division of Vaccine 
Injury Compen., 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
_______________________________________________________________________


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


Health Resources and Services Administration (HRSA)



_______________________________________________________________________




919. 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                    09/00/04

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

[[Page 37469]]

_______________________________________________________________________




920. 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              09/00/04

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
_______________________________________________________________________




921.  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 FY 2005 grant dollars.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

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

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Wayne E. Sauseda Mr., Director, Division of Community 
Based Programs, Department of Health and Human Services, Health 
Resources and Services Administration, 5600 Fishers Lane, Rm. 7A-30, 
Rockville, MD 20857
Phone: 301 443-0493
Fax: 301 443 1839
Email: [email protected]

RIN: 0906-AA65
_______________________________________________________________________


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


Health Resources and Services Administration (HRSA)



_______________________________________________________________________




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

Priority: Substantive, Nonsignificant

Legal Authority: 42 USC 1396r-2

CFR Citation: 45 CFR 60

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                             To Be                       Determined

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: State

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

RIN: 0906-AA57

[[Page 37470]]

_______________________________________________________________________


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


National Institutes of Health (NIH)



_______________________________________________________________________




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

Priority: Substantive, Nonsignificant

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

CFR Citation: 42 CFR 68b

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            11/00/04

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

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

RIN: 0925-AA10
_______________________________________________________________________




924. 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                            07/00/04

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

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

RIN: 0925-AA28
_______________________________________________________________________




925. 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                            09/00/04

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

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

RIN: 0925-AA31
_______________________________________________________________________




926. 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                            07/00/04

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

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

RIN: 0925-AA32
_______________________________________________________________________




927. 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

[[Page 37471]]

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                            11/00/04

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

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

RIN: 0925-AA33
_______________________________________________________________________




928. 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                            11/00/04

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

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

RIN: 0925-AA34
_______________________________________________________________________




929. 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                            11/00/04

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

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

RIN: 0925-AA35
_______________________________________________________________________




930. 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                            11/00/04

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

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

RIN: 0925-AA36
_______________________________________________________________________




931. 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                            08/00/04

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

[[Page 37472]]

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

RIN: 0925-AA41
_______________________________________________________________________


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


National Institutes of Health (NIH)



_______________________________________________________________________




932. 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                    07/00/04

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

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

RIN: 0925-AA18
_______________________________________________________________________




933. NATIONAL INSTITUTES OF HEALTH CENTER GRANTS

Priority: Substantive, Nonsignificant

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

CFR Citation: 42 CFR 52a

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            11/12/02                    67 FR 68548
Final Action                    07/00/04

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Governmental Jurisdictions

Government Levels Affected: None

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

RIN: 0925-AA24
_______________________________________________________________________


Department of Health and Human Services (HHS)         Completed Actions


National Institutes of Health (NIH)



_______________________________________________________________________




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

Priority: Substantive, Nonsignificant

CFR Citation: 42 CFR 52h

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Rule                      01/05/04                      69 FR 272

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

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

RIN: 0925-AA20

[[Page 37473]]

_______________________________________________________________________


Department of Health and Human Services (HHS)             Prerule Stage


Office of Public Health and Science (OPHS)



_______________________________________________________________________




935.  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                           09/00/04
ANPRM Comment Period End        12/00/04

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
_______________________________________________________________________


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


Office of Public Health and Science (OPHS)



_______________________________________________________________________




936. 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 basicguidelines 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                            01/00/04
NPRM Comment Period End         07/00/04

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

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

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

[[Page 37474]]

_______________________________________________________________________


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


Office of Public Health and Science (OPHS)



_______________________________________________________________________




937. 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                    01/00/05

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
_______________________________________________________________________




938. 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 will simultaneously publish a 
proposed rule regarding FDA IRB registration requirements.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            04/16/04                    69 FR 20777
NPRM Comment Period End         06/15/04
Final Action                    12/00/04

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

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

RIN: 0940-AA06
_______________________________________________________________________




939.  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                    09/00/04

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

[[Page 37475]]

_______________________________________________________________________


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


Office of Public Health and Science (OPHS)



_______________________________________________________________________




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

Priority: Other Significant. 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)



_______________________________________________________________________




941. 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                     02/00/05

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses, Organizations

Government Levels Affected: None

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

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

RIN: 0938-AG81
_______________________________________________________________________




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

Priority: Other Significant

Legal Authority: 42 USC 1395rr

CFR Citation: 42 CFR 400; 42 CFR 405; 42 CFR 406; 42 CFR 409; 42 CFR 
410; 42 CFR 412; 42 CFR 488; 42 CFR 489; 42 CFR 494; 42 CFR 413; 42 CFR 
414

Legal Deadline: None

Abstract: This proposed rule would revise the requirements that end 
stage renal disease (ESRD) facilities must meet to be certified under 
the Medicare program.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            10/00/04

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Robert Miller, 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: 410 786-6797

Teresa Casey, Health Insurance Specalist, Department of Health and 
Human Services, Centers for Medicare & Medicaid Services, S3-05-04, 
Office of Clinical Standards and Quality, 7500 Security Boulevard, 
Baltimore, MD 21244
Phone: 410 786-7215

RIN: 0938-AG82

[[Page 37476]]

_______________________________________________________________________




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

Priority: Other Significant

Legal Authority: 42 USC 1302; 42 USC 1395hh

CFR Citation: 42 CFR 482

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            11/00/04

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses, Organizations

Government Levels Affected: None

Agency Contact: Eva Fung, Health Insurance Specialist, Department of 
Health and Human Services, Centers for Medicare & Medicaid Services, 
S3-06-6, Office of Clinical Standards and Quality, S3-06-06, 7500 
Security Boulevard, Baltimore, MD 21244
Phone: 410 786-7539

Aucha Prachanronarong, Health Insurance Specialist, Department of 
Health and Human Services, Centers for Medicare & Medicaid Services, 
Office of Clinical Standards and Quality, S3-02-01, 7500 Security 
Boulevard, Baltimore, MD 21244
Phone: 410 786-9614

RIN: 0938-AH17
_______________________________________________________________________




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

Priority: Other Significant

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

CFR Citation: 42 CFR 418

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            05/00/05

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected:  Businesses, Organizations

Government Levels Affected: None

Federalism:  Undetermined

Agency Contact: Mary Rossi Coajou, Health Insurance Specialist, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, Office of Clinical Standards and Quality, 7500 
Security Boulevard, Baltimore, MD 21244
Phone: 410 786-6051

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

RIN: 0938-AH27
_______________________________________________________________________




945. 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                            11/00/04

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
_______________________________________________________________________




946. 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. Rule will incorporate provisions 
from section 936 of the MMA.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            10/25/99                    64 FR 57431
Second NPRM                     01/00/05

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

[[Page 37477]]

_______________________________________________________________________




947. 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                     05/00/05

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: Federal

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

RIN: 0938-AJ17
_______________________________________________________________________




948. 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                            09/00/04

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
_______________________________________________________________________




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

Priority: Other Significant. Major under 5 USC 801.

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

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

CFR Citation: 45 CFR 162

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

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            11/00/04

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: Federal, Local, State, Tribal

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

Agency Contact: Lorraine Doo, Health Insurance Specialist, Department 
of Health and Human Services, Centers for Medicare & Medicaid Services, 
Office of Health Insurance Portability and Account Act Standards, S2-
26-17, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-6597

RIN: 0938-AK62
_______________________________________________________________________




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

Priority: Other Significant

Legal Authority: 42 USC 1320b-8(b)(1)(A)(i); 42 USC 273(b)(2)

CFR Citation: 42 CFR 486.301

Legal Deadline: Final, Statutory, January 1, 2002, Requires 
promulgation of new conditions.

Abstract: This rule would establish conditions for coverage for organ 
procurement organizations (OPOs) to be certified by the Secretary to 
receive payment from Medicare and Medicaid for organ procurement costs, 
and to be designated by the Secretary for a specific geographic service 
area. The Organ Procurement Organization Certification Act of 2000 
requires CMS to increase the certification cycle for OPOs from two 
years to four years and to promulgate new performance standards for 
OPOs.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              12/28/01                    66 FR 67109
NPRM                            11/00/04

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Marcia Newton, Office of Clinical Standards and

[[Page 37478]]

Quality, Department of Health and Human Services, Centers for Medicare 
& Medicaid Services, S3-02-01, 7500 Security Boulevard, S3-05-18, 
Baltimore, MD 21244-1850
Phone: 410 786-5265

RIN: 0938-AK81
_______________________________________________________________________




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

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

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

CFR Citation: 42 CFR 101; 42 CFR 418; 42 CFR 482; 42 CFR 483; 42 CFR 
485

Legal Deadline: None

Abstract: This proposed rule would implement provisions of the 
Children's Health Act of 2000 (CHA) related to the use of restraints or 
seclusion for individuals receiving services in health care facilities 
that receive Federal funding. The rule would establish common 
terminology and basic expectations for the use of restraints and 
seclusion for health care facilities that furnish inpatient or 
residential care and receive Medicare or Medicaid funding.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            04/00/05

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected:  Businesses

Government Levels Affected: Undetermined

Federalism:  Undetermined

Agency Contact: Carla McGregor, Health Insurance Specialist, Department 
of Health and Human Services, Centers for Medicare & Medicaid Services, 
S2-09-23, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-7089

RIN: 0938-AL26
_______________________________________________________________________




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

Priority: Substantive, Nonsignificant

Legal Authority: Sec 1878 of the Social Security Act

CFR Citation: 42 CFR 405

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            07/00/04

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: None

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

RIN: 0938-AL54
_______________________________________________________________________




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

Priority: Info./Admin./Other

Legal Authority: Not Yet Determined

CFR Citation: None

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/00/04

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
_______________________________________________________________________




954. 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: Sec 1102 of the Social Security Act; Sec 1832 of the 
Social Security Act; Sec 1871 of the Social Security Act

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

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                            05/00/05

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 37479]]

_______________________________________________________________________




955. 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                            12/00/04

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses, Organizations

Government Levels Affected: Federal, Local, State

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

RIN: 0938-AL88
_______________________________________________________________________




956. 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                            02/00/05

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

RIN: 0938-AM50
_______________________________________________________________________




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

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

Legal Authority: 42 USC 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: NPRM, Statutory, January 1, 2004.

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            08/00/04

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

RIN: 0938-AM75
_______________________________________________________________________




958. 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.

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

CFR Citation: None

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            02/00/05

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

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

RIN: 0938-AM79
_______________________________________________________________________




959. PAYMENT ERROR RATE MEASUREMENT (PERM) PROGRAM (CMS-2186-P)

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

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

CFR Citation: None

Legal Deadline: None

[[Page 37480]]

Abstract: Sections 1902(a)(6)and 2107(b)(1) of the Act, governing 
Medicaid and State Children's Health Insurance Program, respectively, 
require States to provide to the Secretary information to monitor 
program performance. This rule would require States under the current 
statutory provisions and the Improper Payments Information Act of 2002 
and through this regulation to estimate improper payments using the CMS 
PERM methodolgy for the reporting year in the Medicaid and State 
Children's Health Insurance Program. The States are further required to 
submit payment error rates to CMS for the purpose of calculating a 
national level payment error rate as required by the Improper Payments 
Information Act of 2002.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/00/04

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: State

Federalism:  Undetermined

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

RIN: 0938-AM86
_______________________________________________________________________




960. 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 a Condition of 
Participation (CoP) for hospice services that long term care (LTC) 
facilities must meet to participate in the Medicare and Medicaid 
programs. We are proposing this new CoP to ensure that quality hospice 
are is 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                            01/00/05

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, 
7500 Security Bloulevard, S3-04-26, Baltimore, MD 21244
Phone: 410 786-5646

RIN: 0938-AM87
_______________________________________________________________________




961. 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 1395 x; 42 USC 1396 d; 42 USC 1395 bb

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 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, and completion of the post-anesthesia 
evaluation.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/00/04

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Organizations

Government Levels Affected: None

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

RIN: 0938-AM88
_______________________________________________________________________




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

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

Legal Authority: 42 USC 1395W-4

CFR Citation: 42 CFR 410; 42 CFR 414

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

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/00/04

Regulatory Flexibility Analysis Required: Yes

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

RIN: 0938-AM90
_______________________________________________________________________




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

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

[[Page 37481]]

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            07/00/04

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Federalism:  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
_______________________________________________________________________




964.  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                            03/00/05

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: None

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

RIN: 0938-AN04
_______________________________________________________________________




965.  MEDICARE ADVANTAGE PROGRAM TITLE II (CMS-4069-P)

Priority: Other Significant

Unfunded Mandates: Undetermined

Legal Authority: Not Yet Determined

CFR Citation: 42 CFR 417; 42 CFR 422

Legal Deadline: None

Abstract: This proposed rule would implement title II of the Medicare 
Prescription Drug and Improvement Modernization Act establishing the 
Medicare Advantage program that would replace the existing 
Medicare+Choice program. Medicare Advantage offers improved managed 
care plans with coordinated care and competitive bidding, to promote 
greater efficiency and responsiveness to Medicare beneficiaries. (Rule 
needs to be published at least one year before January 1, 2006 
implementation to award contracts.)

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/00/04

Regulatory Flexibility Analysis Required: No

Government Levels Affected: Undetermined

Federalism:  Undetermined

Agency Contact: Jane Andrews, Health Insurance Specialist, Department 
of Health and Human Services, Centers for Medicare & Medicaid Services, 
7500 Security Boulevard, C4-13-01, Baltimore, MD 21244-1850
Phone: 410 786-3133
Email: [email protected]

RIN: 0938-AN06
_______________________________________________________________________




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

Priority: Economically Significant. Major under 5 USC 801.

Unfunded Mandates: Undetermined

Legal Authority: P.L. 108-173, 1860D-22

CFR Citation: 42 CFR 423

Legal Deadline: NPRM, Statutory, January 1, 2006.
Statute requires that payments to sponsors begin in 2006.

Abstract: Section 1860(D-22) of the Social Security Act (as added by 
the Medicare Prescription Drug Improvement and Modernization Act) 
establishes special rules for employer sponsored drug programs, 
beginning January 1, 2006, concerning payments to sponsors of retiree 
prescription drug plans.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/00/04

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses, Governmental Jurisdictions, 
Organizations

Government Levels Affected: Undetermined

Federalism:  Undetermined

Agency Contact: James Mayhew, Health Insurance Specialist, Department 
of Health and Human Services, Centers for Medicare & Medicaid Services, 
7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-9344
Email: [email protected]

RIN: 0938-AN07
_______________________________________________________________________




967.  MEDICARE DRUG BENEFIT EFFECTIVE CALENDAR YEAR 
2006 (TITLE I) (CMS-4068-P)

Priority: Economically Significant. Major under 5 USC 801.

Unfunded Mandates: Undetermined

Legal Authority: PL 108-173 (MMA)

CFR Citation: 42 CFR 417; 42 CFR 423

Legal Deadline: None

Abstract: This proposed rule would implement title I of the Medicare 
Prescription Drug Improvement and Modernization Act of 2003 (MMA) that 
establishes a new voluntary outpatient prescription drug benefit under 
a new Medicare part D, beginning January 1, 2006. Options for coverage 
of the drug benefit include private prescription drug plans (PDPs) that 
offer drug only coverage; Medicare Advantage plans; or preferred 
provider plans (PPOs) that would offer prescription drug and nondrug 
coverage. Plans would offer a standard drug benefit but have the

[[Page 37482]]

flexibility to vary the drug benefit within actuarial equivalency 
parameters. Assistance with premiums and cost sharing would be provided 
to eligible low-income beneficiaries.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/00/04

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Federal, State, Tribal

Federalism:  Undetermined

Agency Contact: Tracey McCutcheon, Health Insurance Specialist, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-6715
Email: [email protected]

RIN: 0938-AN08
_______________________________________________________________________




968.  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 regulation will implement section 1923(i) of the Social 
Security Act (the Act). Section 1923(i) of the Act requires States to 
report DSH payment information (name of DSH providers and amount of 
payment they received) to CMS. Under the law, States must also furnish 
CMS with an independent audit that verifies DSH payment to hospitals.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            10/00/04

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: State

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

RIN: 0938-AN09
_______________________________________________________________________




969.  PRIOR DETERMINATION PROCESS (CMS-6024-P)

Priority: Other Significant. Major under 5 USC 801.

Unfunded Mandates: Undetermined

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

CFR Citation: Not Yet Determined

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

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            11/00/04

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

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

RIN: 0938-AN10
_______________________________________________________________________




970.  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: Public Law 108, 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                            03/00/05

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses, Governmental Jurisdictions, 
Organizations

Government Levels Affected: Federal, State

Agency Contact: Michael Patrick, Health Policy Analyst, Department of 
Health and Human Services, Centers for Medicare & Medicaid Services, 
7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-4495
Email: [email protected]

RIN: 0938-AN14
_______________________________________________________________________




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

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

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                            10/00/04

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: None

Agency Contact: Bob Cereghino, Health Insurance Specialist, Department 
of Health and Human

[[Page 37483]]

Services, Centers for Medicare & Medicaid Services, 7500 Security 
Boulevard, Baltimore, MD
Phone: 410 786-4645
Email: [email protected]

RIN: 0938-AN23
_______________________________________________________________________




972.  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 will propose 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                            03/00/05

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: Maria A. Friedman, Health Insurance Specialist, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-6333
Email: [email protected]

RIN: 0938-AN25
_______________________________________________________________________




973.  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, MMA's section 416 eliminates the 
application of the clinical laboratory fee schedule for hospital 
outpatient laboratory testing by a hospital with fewer than 50 beds in 
a qualified rural area for cost reporting periods beginning during the 
two-year period beginning on July 1, 2004. Section 1833(h) of the Act 
mandates payment for outpatient clinical laboratory tests under a 
clinical laboratory fee schedule.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            11/00/04

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, Baltimore, MD 21244
Phone: 410 786-4601
Email: [email protected]

RIN: 0938-AN26
_______________________________________________________________________




974.  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                            12/00/04

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, Baltimore, MD 21244
Phone: 410 786-2590
Email: [email protected]

RIN: 0938-AN28

[[Page 37484]]

_______________________________________________________________________


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


Centers for Medicare & Medicaid Services (CMS)



_______________________________________________________________________




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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              01/22/01                     66 FR 7148
60-Day Delay of Effective Date 
To 05/22/2001                   03/21/01                    66 FR 15800
Interim Final Rule Comment 
Period End                      03/23/01
Interim Final Rule Effective    03/23/01
Interim Final Rule Amendment 
with Clarification              05/22/01                    66 FR 28110
Interim Final Rule Comment 
Period End                      07/23/01
Final Action                    04/00/05

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
_______________________________________________________________________




976. 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
Final Action                    05/00/05

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
_______________________________________________________________________




977. 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                    09/00/06

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: None

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

RIN: 0938-AM22
_______________________________________________________________________




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

Priority: Other Significant. Major under 5 USC 801.

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

CFR Citation: 42 CFR 413.330 to 413.350

Legal Deadline: NPRM, Statutory, July 30, 2004, Statue requires the 
final rule to be published by August 1, 2004.

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Notice                          07/00/04

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: None

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

RIN: 0938-AM46
_______________________________________________________________________




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

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

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

[[Page 37485]]

CFR Citation: 45 CFR 146.180

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule With Comment 
Period                          07/26/02                    67 FR 48802
Final Action                    08/00/04

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: Local, State

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

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




980. REVISIONS TO THE APPEALS PROCESS FOR INITIAL CLAIM DETERMINATIONS 
(CMS-4064-FC)

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 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

________________________________________________________________________

Final Action                    05/00/05

Regulatory Flexibility Analysis Required: No

Government Levels Affected: Federal

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

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




981. 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

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

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              09/00/04

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

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

RIN: 0938-AM74
_______________________________________________________________________




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

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

Legal Authority: 1814(i)(A)

CFR Citation: 42 CFR 418.306(d)

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

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Notice                          08/00/04

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

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

RIN: 0938-AM78
_______________________________________________________________________




983. CHANGES TO THE HOSPITAL INPATIENT PROSPECTIVE PAYMENT SYSTEM AND FY 
2005 RATES (CMS-1428-F)

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

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

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

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

Abstract: This proposed rule would revise 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. In addition, the Addendum,

[[Page 37486]]

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, 2004. This proposed rule also setsforth proposed rate-of-
increase limits as well as proposed policy changes for hospitals and 
hospital units excluded from the prospective payments systems. (The 
statute requires that this proposed and subsequent final rule be 
published by August 1, 2004.)

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            05/18/04                    69 FR 28195
Final Action                    08/00/04

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, C4-07-07, Center for Medicare Management, 7500 
Security Boulevard, C4-07-07, Baltimore, MD 21244
Phone: 410 786-4487

RIN: 0938-AM80
_______________________________________________________________________




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

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

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

CFR Citation: None

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

Abstract: This notice updates rates for the prospective payment system 
for inpatient rehabilitation facilities for FY 2005. (The statute 
requires that this notice be published by August 1, 2004.)

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Action                    07/00/04

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

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

RIN: 0938-AM82
_______________________________________________________________________




985. HOME HEALTH PROSPECTIVE PAYMENT SYSTEM RATE UPDATE FY 2005 (CMS-
1265-P)

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

Legal Authority: Sec 1895 of the Social Security Act, ; Sec 421 of the 
MMA; Sec 701 of the MMA

CFR Citation: Not Yet Determined

Legal Deadline: None

Abstract: This proposed rule would set forth an update to the 60-day 
national episode rates and the national per-visit amounts under the 
Medicare prospective payment system for home health agencies. It also 
proposes to rebase and revise the home health market basket to reflect 
total cost and modify certain variables for some of the cost 
categories. It implements sections 421 (one-year increase in rural 
areas) and 701 (move to CY updates) of the Medicare Modernization Act 
(effective April 1, 2004). (The proposed and final rules must be 
published by September 30, 2004, to allow three months for systems 
changes.)

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/02/04                    69 FR 31248
Final Action                    10/00/04

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: None

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

RIN: 0938-AM93
_______________________________________________________________________




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

Priority: Economically Significant. Major under 5 USC 801.

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

CFR Citation: 42 CFR 405; 42 CFR 414

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

Abstract: This final rule with comment implements section 602 of the 
Medicare Prescription Drug, Improvement and Modernization Act of 2003. 
Specifically, it revises the payment methodology under Medicare for 
Part B covered drugs and biologicals that are not paid on a cost or 
prospective payment basis; makes adjustments to payment for certain 
drug administration services under the physician fee schedule; makes 
revisions to the geographic practice expense cost indices used for 
determining payment under the physician fee schedule and announces a 
1.5 percent increase in the calendar year 2004 physician fee schedule 
conversion factor.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              01/07/04                     69 FR 1084
Interim Final Rule Comment 
Period End                      03/08/04
Correction                      03/26/04                    69 FR 15703
Correction                      06/00/04

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: Federal

Agency Contact: Marc Hartstein, Health Insurance Specialist, Department 
of Health and Human Services, Centers for Medicare & Medicaid Services, 
7500 Security Blvd, Baltimore, MD 21244
Phone: 410 786-4539
Email: [email protected]

RIN: 0938-AM97

[[Page 37487]]

_______________________________________________________________________




987.  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

Legal Authority: Sec 1877 of the Social Security Act

CFR Citation: None

Legal Deadline: None

Abstract: This final rule delays for six months the effective date of 
the last sentence of 42 CFR 411.354(d)(1) of the physician self-
referral rule published on January 4, 2001. This sentence defines 
compensation that is ``set in advance'' as it relates to percentage 
compensation methodologies.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Action                    07/00/04

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Karen Raschke, Department of Health and Human Services, 
Centers for Medicare & Medicaid Services, 7500 Security Blvd, 
Baltimore, MD 21244
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
_______________________________________________________________________




988.  TIME LIMITATION ON RECORD KEEPING REQUIREMENTS 
UNDER THE DRUG REBATE PROGRAM (CMS-2188-P)

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

Unfunded Mandates: Undetermined

Legal Authority: Not Yet Determined

CFR Citation: Not Yet Determined

Legal Deadline: None

Abstract: This proposed rule would establish ten-year record keeping 
requirements for drug manufacturers under the Medicaid drug rebate 
program.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            01/06/04                      69 FR 565
Final Action                    12/00/04

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Federalism:  Undetermined

Agency Contact: Marge Watchorn, Department of Health and Human 
Services, Centers for Medicare & Medicaid Services, 7500 Security 
Boulevard, Baltimore, MD 21244
Phone: 410 786-4361
Email: [email protected]

RIN: 0938-AN01
_______________________________________________________________________




989.  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

Legal Authority: 42 USC 1302

CFR Citation: None

Legal Deadline: None

Abstract: This notice extends availability of unexpended SCHIP funds 
from the appropriation for fiscal years 1998 through 2004 and provides 
the authority for qualifying States to use a portion of SCHIP funds for 
Medicaid expenditures.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Action                    06/00/04

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Governmental Jurisdictions

Government Levels Affected: State

Agency Contact: Richard Strauss, Division 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-AN03
_______________________________________________________________________




990.  FY 2005 SCHIP ALLOTMENTS (CMS-2201-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 2005. (The notice must 
be published as soon as possible so that the funds can be distributed 
to the States before September 30, 2004, as required by the statute.)

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Action                    08/00/04

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-AN11
_______________________________________________________________________




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

Priority: Info./Admin./Other

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                          09/00/04

Regulatory Flexibility Analysis Required: No

[[Page 37488]]

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, 
7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-4492
Email: [email protected]

RIN: 0938-AN12
_______________________________________________________________________




992.  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 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 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                          09/00/04

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, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-1775
Email: [email protected]

RIN: 0938-AN13
_______________________________________________________________________




993.  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: Other Significant

Legal Authority: 42 USC 1395-2(d)(2); 42 USC 1395i-2a(d)(2); Social 
Security Act, sec 1818(d)(2); Social Security Act, sec 1818A(d)(2)

CFR Citation: None

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

Abstract: This notice announces the hospital insurance premium for 
Calendar Year 2005 under Medicare's Hospital Insurance Program 
(Medicare part A) for the uninsured aged and for certain disabled 
individuals who have exhausted other entitlement. (CMS generally 
publishes this notice to coincide with the SSA Cola announcement.)

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Notice                          10/00/04

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

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

RIN: 0938-AN15
_______________________________________________________________________




994.  INPATIENT HOSPITAL DEDUCTIBLE AND HOSPITAL AND 
EXTENDED CARE SERVICES COINSURANCE AMOUNTS FOR CALENDAR YEAR 2005 (CMS-
8021-N)

Priority: Other Significant

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

CFR Citation: None

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

Abstract: This notice announces the inpatient hospital deductible and 
the hospital and extended care services coinsurance amounts for 
services furnished in Calendar Year 2005 under Medicare's Hospital 
Insurance program (Medicare part A). The Medicare statute specifies the 
formula used to determine these amounts. (CMS generally publishes this 
notice to coincide with the SSA Cola announcement.)

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Notice                          10/00/04

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

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

RIN: 0938-AN16
_______________________________________________________________________




995.  MEDICARE PART B MONTHLY ACTUARIAL RATES AND 
PREMIUM RATE BEGINNING JANUARY 1, 2005 (CMS-8020-N)

Priority: Other Significant

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

CFR Citation: None

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

Abstract: Section 629 of the Medicare Modernization Act requires 
indexing the part B deductible to inflation beginning January 1, 2005. 
This notice announces the monthly actuarial rates for aged (65 and 
over) and disabled

[[Page 37489]]

(under age 65) enrollees in part B of Medicare for 2005. It also 
announces the monthly Part B premium to be paid by all enrollees during 
2005. (CMS generally publishes this notice to coincide with the SSA 
Cola announcement.)

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Action                    10/00/04

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Carter Warfield, Deputy Director, Medicare & Medicaid 
Cost Estimates Group, Department of Health and Human Services, Centers 
for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, 
MD 21244
Phone: 410 786-6396
Email: [email protected]

RIN: 0938-AN18
_______________________________________________________________________




996.  FEE SCHEDULE FOR PAYMENT OF AMBULANCE SERVICES-
UPDATE FOR CALENDAR YEAR 2005 (CMS-1267-N)

Priority: Economically Significant. Major under 5 USC 801.

Legal Authority: 1861(S)(7); 1834(I)(3)(B); 221 BIPA

CFR Citation: 414.620(f) CFR; 414.610(c)(5) CFR; 414.615 CFR; 414.605 
CFR

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

Abstract: This notice updates the fee schedule for ambulance services 
under the Medicare program, implementing section 1834(1) of the Social 
Security Act. (This nonmajor rule must be published by December 1, 
2004, to be effective January 1, 2005)

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Notice                          12/00/04

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Ann Tayloe, Health Insurance Specialist, CMS/CMM/HAPG/
DAS, Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-4546
Email: [email protected]

RIN: 0938-AN20
_______________________________________________________________________




997.  PROCEDURE FOR PRODUCING GUIDANCE DOCUMENTS 
DESCRIBING MEDICARE'S COVERAGE PROCESS (CMS-3141-N)

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

Legal Authority: Sec 731 of the MMA

CFR Citation: None

Legal Deadline: Other, Statutory, January 1, 2004, Required by Section 
731 of the MMA.

Abstract: Section 731 of the Medicare Prescription Drug Improvement and 
Modernization Act of 2003 (MMA) requires that the Secretary make 
available to the public the factors considered in making national 
coverage determinations of whether an item or service is reasonable and 
necessary. This notice describes a proposed method of developing and 
making public guidance documents consistent with these requirements and 
invites public comment on this process beginning January 1, 2005.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Action                    08/00/04

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Vadim Lubarsky, Technical Adivsor, Department of Health 
and Human Services, Centers for Medicare & Medicaid Services, 7500 
Security Boulevard, Baltimore, MD 21244
Phone: 410 786-0840
Email: [email protected]

RIN: 0938-AN21
_______________________________________________________________________




998.  AMENDMENT TO THE INTERIM FINAL REGULATION FOR 
MENTAL HEALTH PARITY (CMS-2152-F2)

Priority: Other Significant

Legal Authority: Not Yet Determined

CFR Citation: 45 CFR 146.136

Legal Deadline: None

Abstract: The amendment to the interim final rule changes the sunset 
date of regulations under the Mental Health Parity Act of 1996 (MHPA). 
The MHPA as initially enacted had a sunset date of September 30, 2001. 
The implementing regulations published in 1997 included a corresponding 
sunset date. Subsequent legislation enacted on January 10, 2002, 
extended the sunset date of the MHPA to December 31, 2002. Legislation 
enacted on December 2, 2002, extended the sunset date again, to 
December 31, 2003. Therefore, this amendment to the 1997 regulations 
extends the sunset date of the regulations to December 31, 2004, 
consistent with the MHPA.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              06/27/03                    68 FR 38206
Final Action                    07/00/04

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-AN22
_______________________________________________________________________




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

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

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 7, 2004. It also increases mileage payments for certain long 
trips.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              07/00/04

[[Page 37490]]

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: Local

Federalism:  Undetermined

Agency Contact: Robert Niemann, Health Insurance Specialist, CMS/CMM/
HAPG/DAS, Department of Health and Human Services, Centers for Medicare 
& Medicaid Services, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-4596
Email: [email protected]

RIN: 0938-AN24
_______________________________________________________________________




1000.  MEDICARE SECONDARY PAYER (MSP): WORKMEN'S 
COMPENSATION (CMS-1272-FC)

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

________________________________________________________________________

Final Action                    06/00/05

Regulatory Flexibility Analysis Required: No

Government Levels Affected: Undetermined

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

RIN: 0938-AN27
_______________________________________________________________________




1001.  RANDOM PREPAYMENT REVIEW (CMS-6022-IFC)

Priority: Other Significant. Major under 5 USC 801.

Legal Authority: Sec 934 of the MMA

CFR Citation: Not Yet Determined

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

Abstract: Section 934 of the Medicare Modernization Act establishes 
requirements for prepayment medical review of a provider beginning 
December 8, 2004. This regulation will establish contractor standards 
relating to the initiation and termination of nonrandom prepayment 
reivew.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule With Comment 
Period                          12/00/04

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Federalism:  Undetermined

Agency Contact: Ann 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
_______________________________________________________________________




1002.  ADDITIONAL PAYMENTS FOR CERTAIN MEDICARE PART B 
DRUGS (CMS-1280-FC)

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

Legal Authority: Sec 303(e)(2) of the Medicare Modernization Act of 
2003

CFR Citation: 42 CFR 414.1000 to 414.1002

Legal Deadline: None

Abstract: This final rule with comment period continues the 
implementation of section 303(e)(2) of the Medicare Prescription Drug, 
Improvement, and Modernization Act (MMA) of 2003 by establishing a 
separate billable fee to be paid to pharmacies for supplying certain 
Medicare part B drugs and biologicals.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Rule With Comment Period  12/00/04

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: None

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

RIN: 0938-AN34
_______________________________________________________________________




1003.  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 regards 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

________________________________________________________________________

Final Action                    05/00/05

Regulatory Flexibility Analysis Required: 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

[[Page 37491]]

_______________________________________________________________________




1004.  FIRE SAFETY REQUIREMENTS FOR CERTAIN HEALTH 
CARE FACILITIES, AMENDMENT (CMS-3047-F2)

Priority: Other Significant

Legal Authority: Not Yet Determined

CFR Citation: None

Legal Deadline: None

Abstract: This final rule amends the fire safety standard for religious 
nonmedical health care institutions, hospices, programs of all-
inclusive care for the elderly, hospitals, long term care facilities, 
intermediate care facilities for the mentally retarded, and critical 
access hospitals that participate in Medicare and Medicaid. The rule 
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 
will allow facilities to place alcohol-based hand sanitizer dispensers 
in exit corridors under certain conditions. These sanitizers have 
proven to be effective in increasing hand hygiene and have the 
potential to improve infection control practice. Adopting the LSC 
change would increase a provider's flexibility in meeting infection 
control goals while minimizing potential fire safety concerns.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Action                    05/00/05

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

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
_______________________________________________________________________


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


Centers for Medicare & Medicaid Services (CMS)



_______________________________________________________________________




1005. 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 re-enroll providers with time frames for re-enrollment.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

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

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: None

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

RIN: 0938-AH73
_______________________________________________________________________




1006. 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                    11/00/06

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: Aucha Prachanronarong, 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: 410 786-9614

RIN: 0938-AJ10
_______________________________________________________________________




1007. HOSPITAL CONDITIONS OF PARTICIPATION: LABORATORY SERVICES (CMS-
3014-F)

Priority: Substantive, Nonsignificant

Legal Authority: 42 USC 1302; 42 USC 1395hh

CFR Citation: 42 CFR 482.27

Legal Deadline: None

Abstract: This rule requires hospitals that transfuse blood and blood 
products to prepare and follow written procedures for appropriate 
action when it is determined that blood and blood products the hospital 
received and transfused are at increased risk for transmitting HCV; 
quarantine prior collections from a donor who is at increased risk for 
transmitting 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
Final Action                     To Be                       Determined

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: None

[[Page 37492]]

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
_______________________________________________________________________




1008. 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
_______________________________________________________________________




1009. 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 & 424

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              03/26/04                    69 FR 16054
Interim Final Rule Comment 
Period End                      06/24/04
Final Action                    03/00/07

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses, Organizations

Government Levels Affected: None

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

RIN: 0938-AK67
_______________________________________________________________________




1010. CONTINUATION OF MEDICARE ENTITLEMENT WHEN DISABILITY BENEFIT ENDS 
BECAUSE OF SUBSTANTIAL GAINFUL ACTIVITY (CMS-4018-F)

Priority: Substantive, Nonsignificant

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

CFR Citation: 42 CFR 406.12

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            07/25/03                    68 FR 43998
Final Action                    07/00/06

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

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

RIN: 0938-AK94
_______________________________________________________________________




1011. MEDICARE PROGRAM; INTEREST CALCULATION (CMS-6014-F)

Priority: Other Significant

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

CFR Citation: 42 CFR 405.378; 42 CFR 411.24

Legal Deadline: None

Abstract: This final rule will change the formula for computing 
interest on provider and supplier overpayments and underpayments to 
make it consistent with the new CMS accounting system, Healthcare 
Integrated General Ledger Accounting System.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            07/25/03                    68 FR 43995
Final Action                    07/00/06

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses, Organizations

Government Levels Affected: None

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

RIN: 0938-AL14

[[Page 37493]]

_______________________________________________________________________




1012. HEALTH COVERAGE PORTABILITY FOR GROUP HEALTH PLANS AND GROUP 
HEALTH INSURANCE ISSUERS (CMS-2151-F)

Priority: Other Significant. Major under 5 USC 801.

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

CFR Citation: 45 CFR 144.103; 45 CFR 146.111; 45 CFR 146.113; 45 CFR 
146.115; 45 CFR 146.117; 45 CFR 146.119; 45 CFR 146.120; 45 CFR 
146.125; 45 CFR 146.143; . . .

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              04/08/97                    62 FR 16894
Interim Final Rule Comment 
Period End                      07/07/97
Interim Final Rule Effective    07/07/97
Final Action                    12/00/06

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: Federal, Local, State

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

RIN: 0938-AL43
_______________________________________________________________________




1013. PROSPECTIVE PAYMENT SYSTEM FOR INPATIENT PSYCHIATRIC FACILITIES FY 
2004 (CMS-1213-F)

Priority: Other Significant

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 sets forth a prospective payment system (PPS) 
for inpatient psychiatric facilities and psychiatric units.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            11/28/03                    68 FR 66919
Final Action                    11/00/06

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, Baltimore, MD 21244
Phone: 410 786-4533

RIN: 0938-AL50
_______________________________________________________________________




1014. 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
Final Action                    03/00/07

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: None

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

RIN: 0938-AL76
_______________________________________________________________________




1015. PROCEDURES FOR MAINTAINING CODE LISTS IN THE NEGOTIATED NATIONAL 
COVERAGE DETERMINATIONS FOR CLINICAL DIAGNOSTIC LABORATORY SERVICES 
(CMS-3119-F)

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) that were announced in 66 FR 58788 on 
November 25, 2001.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/24/03                    68 FR 74607
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
_______________________________________________________________________




1016. HOSPITAL PATIENTS' RIGHTS COP--STANDARD SAFETY COMPLIANCE 
COMMITTEES (CMS-3120-P)

Priority: Economically Significant. Major under 5 USC 801.

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

CFR Citation: 42 CFR 482

Legal Deadline: None

Abstract: This proposed rule would allow hospitals to waive the current 
requirement that a physician or licensed independent practitioner 
perform a one-hour face-to-face

[[Page 37494]]

evaluation of a patient in restraint or seclusion for the purpose of 
behavior management. Under this proposed rule, a hospital could choose 
to have the one-hour assessment performed by another practitioner, such 
as a registered nurse, if that hospital established a Protections 
Compliance Committee to oversee the use of restraint or seclusion

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                             To Be                       Determined

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses, Organizations

Government Levels Affected: Undetermined

Federalism:  Undetermined

Agency Contact: Rachael Weinstein, Health Insurance Specialist, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-6775

RIN: 0938-AM39
_______________________________________________________________________




1017. REQUIREMENTS FOR NURSING HOMES TO IDENTIFY THE NUMBER OF LICENSED 
AND UNLICENSED NURSES (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 and 
requires nursing homes to post daily, for each shift, the number of 
full-time equivalents (FTEs) of registered nurses, licensed practical 
nurses, licensed vocational nurses, and certified nurse aides who are 
directly responsible for resident care.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

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

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Anita Panicker, 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
_______________________________________________________________________




1018. COVERED OUTPATIENT DRUGS UNDER THE MEDICAID DRUG REBATE PROGRAM 
(CMS-2174-P)

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

Unfunded Mandates: Undetermined

Legal Authority: Sec 1905 (a) (12) of the Social Security Act; Sec 1903 
(a) of the Social Security Act ; Sec 1902 (a) (54) of the Social 
Security Act ; Sec 1903 (i) (10) of the Social Security Act ; Sec 1927 
of the Social Security Act

CFR Citation: 42 CFR 441 ; 42 CFR 447

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                             To Be                       Determined

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Federalism:  Undetermined

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

RIN: 0938-AM81
_______________________________________________________________________




1019. REVISIONS TO COST SHARING REGULATIONS (CMS-2144-P)

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

Unfunded Mandates: Undetermined

Legal Authority: Sec 1916 of the Social Security Act ; Sec 1902(a)(4) 
of the Social Security Act

CFR Citation: 42 CFR 447.51 to 447.56

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                             To Be                       Determined

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Federal, State

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

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

RIN: 0938-AM94
_______________________________________________________________________




1020.  MEDICARE PROGRAM; HOSPITAL OUTPATIENT 
PROSPECTIVE PAYMENT SYSTEM PAYMENT REFORM FOR CALENDAR YEAR 2004 CMS-
1371-IFC

Priority: Other Significant. Major under 5 USC 801.

Legal Authority: Not Yet Determined

CFR Citation: Not Yet Determined

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

Abstract: This rule revises payment rates for drugs in 2004 and 2005. 
(Section 621 of MMA requires the rule to be implemented by January 1, 
2004.)

[[Page 37495]]

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              01/06/04                      69 FR 820
Final Action                    01/00/07

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Federalism:  Undetermined

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

RIN: 0938-AM96
_______________________________________________________________________




1021.  PAYMENT FOR RESPIRATORY ASSIST DEVICES WITH BI-
LEVEL CAPABILITY AND A BACK-UP RATE (CMS-1167-F)

Priority: Other Significant

Unfunded Mandates: Undetermined

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 USC 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
_______________________________________________________________________




1022.  MANUFACTURERS' SUBMISSION OF AVERAGE SALES 
PRICE DATA FOR MEDICARE PART B DRUGS AND BIOLOGICALS (CMS-1380-IFC)

Priority: Other Significant

Unfunded Mandates: Undetermined

Legal Authority: Sec 303(c) of the MMA 2003

CFR Citation: Not Yet Determined

Legal Deadline: None

Abstract: Section 303(c) of the Medicare Prescription Drug Improvement 
and Modernization Act requires manufacturers to submit average sales 
price data on Medicare part B drugs. This regulation provides 
instruction to manufacturers on the data submission requirements.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              04/06/04                    69 FR 17935
Final Action                    04/00/07

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses, Governmental Jurisdictions

Government Levels Affected: Federal

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

RIN: 0938-AN05
_______________________________________________________________________




1023.  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, 7500 Security 
Boulevard, Baltimore, MD 21244
Phone: 410 786-7533
Email: [email protected]

RIN: 0938-AN19
_______________________________________________________________________




1024.  NONDISCRIMINATION IN HEALTH COVERAGE AND 
BONAFIDE 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

[[Page 37496]]

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, 
7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-6851
Email: [email protected]

RIN: 0938-AN29
_______________________________________________________________________




1025.  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: 1) notification of his or her rights; 
2) the exercise of his or her rights in regard to his or her care; 3) 
privacy and safety; 4) confidentiality of patient records; 5) freedom 
from restraints used in the provision of acute medical and surgical 
care unless clinically necessary; and 6) freedom from seclusion and 
restraint for behavior management unless clinically necessary.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

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, 7500 Security 
Boulevard, Baltimore, MD 21244
Phone: 410 786-6899
Email: [email protected]

RIN: 0938-AN30
_______________________________________________________________________


Department of Health and Human Services (HHS)         Completed Actions


Centers for Medicare & Medicaid Services (CMS)



_______________________________________________________________________




1026. HEALTH INSURANCE REFORM: STANDARD UNIQUE HEALTH CARE PROVIDER 
IDENTIFIER (CMS-0045-F)

Priority: Other Significant. Major under 5 USC 801.

CFR Citation: 42 CFR 160; 42 CFR 162

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    01/23/04                     69 FR 3434

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: Federal, Local, State, Tribal

Agency Contact: Patricia Peyton
Phone: 410 786-1812

RIN: 0938-AH99
_______________________________________________________________________




1027. COVERAGE OF RELIGIOUS NONMEDICAL HEALTH CARE INSTITUTIONS (CMS-
1909-F)

Priority: Substantive, Nonsignificant

CFR Citation: 42 CFR 403.736; 42 CFR 403. 738; 42 CFR 489.102

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    11/28/03                    68 FR 66710

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Jean Marie Moore
Phone: 410 786-3508

RIN: 0938-AI93
_______________________________________________________________________




1028. ALL PROVIDER BAD DEBT PAYMENT (CMS-1126-F)

Priority: Other Significant. Major under 5 USC 801.

CFR Citation: 42 CFR 413.80; 42 CFR 413.178

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn                       06/02/04

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: None

Agency Contact: Katie Walker
Phone: 410 786-7278

RIN: 0938-AK02
_______________________________________________________________________




1029. REVIEW OF NATIONAL COVERAGE DETERMINATIONS AND LOCAL COVERAGE 
DETERMINATIONS (CMS-3063-F)

Priority: Other Significant

CFR Citation: 42 CFR 405

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    11/07/03                    68 FR 63691

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-AK60
_______________________________________________________________________




1030. RATE OF REIMBURSEMENT OF PHOTOCOPY EXPENSES FOR QUALITY 
IMPROVEMENT ORGANIZATIONS (CMS-3055-F)

Priority: Substantive, Nonsignificant

CFR Citation: 42 CFR 476.78

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    12/05/03                    68 FR 67955

[[Page 37497]]

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Les Caplan
Phone: 410 786-7223

RIN: 0938-AK68
_______________________________________________________________________




1031. ELIMINATION OF STATEMENT OF INTENT PROCEDURES FOR FILING MEDICARE 
CLAIMS (CMS-1185-F)

Priority: Other Significant

CFR Citation: 42 CFR 424

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    04/23/04                    69 FR 21963

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: Federal, State

Agency Contact: David Walczak
Phone: 410 786-4475

RIN: 0938-AK79
_______________________________________________________________________




1032. PERMITTING PREMIUM REDUCTIONS AS ADDITIONAL BENEFITS UNDER 
MEDICARE+CHOICE PLANS (CMS-6016-F)

Priority: Substantive, Nonsignificant

CFR Citation: 42 CFR 408

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    11/28/03                    68 FR 66721

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: Federal, Local, State

Agency Contact: Michele Sanders
Phone: 410 786-0808

RIN: 0938-AL49
_______________________________________________________________________




1033. CHANGES TO THE HOSPITAL OUTPATIENT PROSPECTIVE PAYMENT SYSTEM AND 
CALENDAR YEAR 2004 PAYMENT RATES (CMS-1471-F)

Priority: Other Significant. Major under 5 USC 801.

CFR Citation: Not Yet Determined

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    11/07/03                    68 FR 63398

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: Federal

Agency Contact: Cindy Read
Phone: 410 786-1852

RIN: 0938-AL91
_______________________________________________________________________




1034. CRITERIA FOR DETERMINING WHETHER A DRUG IS CONSIDERED USUALLY 
SELF-ADMINISTERED (CMS-1228-P)

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

CFR Citation: Not Yet Determined

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn                       04/26/04

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Federalism:  Undetermined

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

RIN: 0938-AM13
_______________________________________________________________________




1035. INPATIENT HOSPITAL DEDUCTIBLE AND HOSPITAL AND EXTENDED CARE 
SERVICES COINSURANCE AMOUNTS FOR CALENDAR YEAR 2004 (CMS-8016-N)

Priority: Other Significant

CFR Citation: None

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Notice                          10/24/03                    68 FR 60995

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Clare McFarland
Phone: 410 786-6390

RIN: 0938-AM31
_______________________________________________________________________




1036. MONTHLY ACTUARIAL RATES AND MONTHLY SUPPLEMENTARY MEDICAL 
INSURANCE PREMIUM RATE BEGINNING JANUARY 1, 2004 (CMS-8017-N)

Priority: Other Significant

CFR Citation: None

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Notice                          10/24/03                    68 FR 60997

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Carter S. Warfield
Phone: 410 786-6396

RIN: 0938-AM32
_______________________________________________________________________




1037. PART A PREMIUMS FOR CALENDAR YEAR 2004 FOR THE UNINSURED AGED AND 
FOR CERTAIN DISABLED INDIVIDUALS WHO HAVE EXHAUSTED OTHER ENTITLEMENT 
(CMS-8018-N)

Priority: Other Significant

CFR Citation: None

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Notice                          10/24/03                    68 FR 61002

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Clare McFarland
Phone: 410 786-6390

RIN: 0938-AM33
_______________________________________________________________________




1038. GRANTS TO STATES FOR OPERATION OF QUALIFIED HIGH RISK POOLS (CMS-
2179-FC)

Priority: Other Significant

CFR Citation: 45 CFR 148

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    03/26/04                    69 FR 15695

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: State

Agency Contact: James Mayhew
Phone: 410 786-9244

RIN: 0938-AM42

[[Page 37498]]

_______________________________________________________________________




1039. FEE SCHEDULE FOR PAYMENT OF AMBULANCE SERVICES UPDATE FOR CALENDAR 
YEAR 2004 (CMS-1232-FCC)

Priority: Other Significant

CFR Citation: None

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Rule                      12/05/03                    68 FR 67960

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Anne Tayloe
Phone: 410 786-4546

RIN: 0938-AM44
_______________________________________________________________________




1040. EXCLUSION OF MEDICARE BENEFITS FOR ALIENS NOT LAWFULLY PRESENT IN 
THE UNITED STATES (CMS-1222-FC)

Priority: Other Significant

CFR Citation: 42 CFR 411.11

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn                       11/28/03

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Frederick William Grabau
Phone: 410 786-0206

RIN: 0938-AM47
_______________________________________________________________________




1041. REVISED CIVIL MONEY PENALTIES, ASSESSMENTS, EXCLUSIONS, AND 
RELATED APPEALS PROCEDURES (CMS-6146-P)

Priority: Other Significant

CFR Citation: 42 CFR 402, subpart C & 402.3

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn                       05/11/04

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Joel Cohen
Phone: 410 786-3349

Related RIN: Duplicate of 0938-AM98
RIN: 0938-AM54
_______________________________________________________________________




1042. CHANGES TO THE CRITERIA FOR BEING CLASSIFIED AS AN INPATIENT 
REHABILITATION FACILITY (CMS-1262-F)

Priority: Economically Significant

CFR Citation: 42 CFR 412

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Rule                      05/07/04                    69 FR 25751

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Robert Kuhl
Phone: 410 786-4597

Related RIN: Split from 0938-AL95
RIN: 0938-AM72
_______________________________________________________________________




1043. PROSPECTIVE PAYMENT SYSTEM FOR LONG-TERM CARE HOSPITALS: ANNUAL 
PAYMENT RATE UPDATES AND POLICY CHANGES (EFFECTIVE 7/1/04) (CMS-1263-F)

Priority: Other Significant

CFR Citation: 42 CFR 412 ; 42 CFR 413

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

NPRM                            01/30/04                     69 FR 4754
Final Action                    05/07/04                    69 FR 25673

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Tzvi Hefter
Phone: 410 786-4487

RIN: 0938-AM84
_______________________________________________________________________




1044. DISPROPORTIONATE SHARE HOSPITAL (DSH) PAYMENTS INSTITUTIONS FOR 
MENTAL DISEASE (IMDS) (CMS-2062-N)

Priority: Other Significant

CFR Citation: None

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Notice                          03/26/04                    69 FR 15850

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Jim Frizzera
Phone: 410 786-9535

RIN: 0938-AM89
_______________________________________________________________________




1045.  PHYSICIANS' REFERRALS TO HEALTH CARE ENTITIES 
WITH WHICH THEY HAVE FINANCIAL RELATIONSHIPS: EXTENSION OF PARTIAL DELAY 
OF EFFECTIVE DATE (CMS-1809-F4)

Priority: Other Significant

Legal Authority: None

CFR Citation: None

Legal Deadline: None

Abstract: This final rule delays for six months the effective date of 
the last sentence of 42 CFR 411.354(d)(1) of the physician self-
referral rule published on January 4, 2001. This sentence defines 
compensation that is ``set in advance'' as it relates to percentage 
compensation methodologies. (The rule will be published only if Stark 
II, Phase II (CMS-1810-FC) is not published by December 31, 2003.)

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Action                    12/24/03                    68 FR 74491

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Karen Raschke, Department of Health and Human Services, 
Centers for Medicare & Medicaid Services, 7500 Security Blvd, 
Baltimore, MD 21244
Phone: 410 786-0016
Email: [email protected]

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




1046.  NOTICE OF ONE-TIME APPEAL PROCESS FOR HOSPITAL 
WAGE INDEX CLASSIFICATION (CMS-1373-N)

Priority: Info./Admin./Other

Legal Authority: Sec 508(a) of the Medicare Prescription Drug 
Improvement and Moderization Act of 2003

[[Page 37499]]

CFR Citation: None

Legal Deadline: None

Abstract: This notice implements section 508(a) of Public Law 108-173. 
This section provides that, by January 1, 2004, the Secretary must 
establish by instruction or otherwise, a process under which a hospital 
may appeal the wage index classification otherwise applicable to the 
hospital. (Statute requires notice be implemented and announced by 1/1/
04, and applications be received by 2/15/04.)

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Notice                          01/06/03                      68 FR 661
Notice                          02/13/04                     69 FR 7340

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Stephen Phillips, Deputy Division Director, Division of 
Acute Care, Department of Health and Human Services, Centers for 
Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, MD 
21244
Phone: 410 786-4548
Email: [email protected]

Related RIN: Related to 0938-AN17
RIN: 0938-AN00
_______________________________________________________________________


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


Administration for Children and Families (ACF)



_______________________________________________________________________




1047. 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 enforcementagencies. The legislation has 
rendered obsolete or inconsistent several regulations at 45 CFR chapter 
III, Office of Child Support Enforcement, including the regulations on 
the Federal Parent Locator Service, the State Parent Locator Services, 
offset of Federal payments for purposes of collecting child support, 
and safeguarding of information. This regulation would update various 
sections in 45 CFR chapter III to reflect the statutory changes.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            01/00/05

Regulatory Flexibility Analysis Required: No

Government Levels Affected: State, Local, Tribal

Agency Contact: Eileen C. Brooks, Deputy Director, Policy Division, 
Department of Health and Human Services, Administration for Children 
and Families, 4th Floor East, OCSE, DPP, 370 L'Enfant Promenade SW., 
Washington, DC 20447
Phone: 202 401-5369
TDD Phone: 800 877-8339
Fax: 202 401-4054
Email: [email protected]

RIN: 0970-AC01
_______________________________________________________________________




1048. DEVELOPMENTAL DISABILITIES AND BILL OF RIGHTS ACT

Priority: Substantive, Nonsignificant

Legal Authority: PL 106-402; USC 15001 et seq

CFR Citation: 45 CFR 1385 to 1388

Legal Deadline: Final, Statutory, October 30, 2001.

Abstract: A notice of proposed rulemaking will be published in the 
Federal Register to amend current regulations and to implement changes 
made by the Developmental Disabilities Assistance and Bill of Rights 
Act of 2000.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            01/00/05

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Governmental Jurisdictions, Organizations

Government Levels Affected: State, Local, Tribal

Agency Contact: Elsbeth Wyatt, Program Specialist, Department of Health 
and Human Services, Administration for Children and Families, ADD HHH-
300F, 370 L'Enfant Promenade SW., Washington, DC 20447
Phone: 202 690-5841

RIN: 0970-AC07
_______________________________________________________________________




1049. ADMINISTRATIVE COSTS FOR CHILDREN IN TITLE IV-E FOSTER CARE

Priority: Substantive, Nonsignificant

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

CFR Citation: 45 CFR 1356.60(c)

Legal Deadline: None

Abstract: This notice of proposed rulemaking implements the title IV-E 
foster care eligibility and administrative cost provisions in sections 
472 and 474 of the Social Security Act. We propose to prohibit the 
reimbursement of administrative costs claimed on behalf of children in 
unlicensed foster family homes, with the exception of children in 
relative foster family homes while the State is in the process of 
licensing the home. We also propose to prohibit the reimbursement of 
administrative costs claimedon 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

[[Page 37500]]

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
_______________________________________________________________________




1050. ADMINISTRATIVE COST SHARING UNDER TANF

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

Legal Authority: 42 USC 1302

CFR Citation: 45 CFR 263; 45 CFR 263.14

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            10/00/05

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: Local, State

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

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

RIN: 0970-AC15
_______________________________________________________________________


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


Administration for Children and Families (ACF)



_______________________________________________________________________




1051. CHILD SUPPORT ENFORCEMENT PROGRAM; FEDERAL TAX REFUND OFFSET

Priority: Substantive, Nonsignificant

Legal Authority: 42 USC 664; 42 USC 1302

CFR Citation: 45 CFR 303.72

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              06/26/03                    68 FR 37978
Final Action                    01/00/05

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: State

Agency Contact: Eileen C. Brooks, Deputy Director, Policy Division, 
Department of Health and Human Services, Administration for Children 
and Families, 4th Floor East, OCSE, DPP, 370 L'Enfant Promenade SW., 
Washington, DC 20447
Phone: 202 401-5369
TDD Phone: 800 877-8339
Fax: 202 401-4054
Email: [email protected]

RIN: 0970-AC09
_______________________________________________________________________




1052.  HEAD START TRANSPORTATION

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

Legal Authority: Not Yet Determined

CFR Citation: 45 CFR 1310

Legal Deadline: None

Abstract: This interim 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                    12/00/04

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

[[Page 37501]]

_______________________________________________________________________


Department of Health and Human Services (HHS)         Completed Actions


Administration for Children and Families (ACF)



_______________________________________________________________________




1053. CHILD SUPPORT ENFORCEMENT FOR INDIAN TRIBES

Priority: Other Significant

CFR Citation: 45 CFR 309

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Rule                      03/30/04                    69 FR 16638

Regulatory Flexibility Analysis Required: No

Government Levels Affected: State, Tribal

Agency Contact: Paige Biava
Phone: 202 401-9386

RIN: 0970-AB73
_______________________________________________________________________




1054. CHARITABLE CHOICE PROVISIONS APPLICABLE TO THE TEMPORARY 
ASSISTANCE FOR NEEDY FAMILIES PROGRAM

Priority: Other Significant

CFR Citation: 45 CFR 260.30; 45 CFR 260.34

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Rule                      09/30/03                    68 FR 56449

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: State

Agency Contact: April Kaplan
Phone: 202 401-5138
Email: [email protected]

RIN: 0970-AC12
_______________________________________________________________________




1055. COMMUNITY SERVICES BLOCK GRANT CHARITABLE CHOICE

Priority: Substantive, Nonsignificant

CFR Citation: 45 CFR 1050

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Rule                      09/30/03                    68 FR 56466

Regulatory Flexibility Analysis Required: No

Government Levels Affected: Federal

Agency Contact: Clarence Carter
Phone: 202 401-9333
Email: [email protected]

RIN: 0970-AC13
_______________________________________________________________________


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


Administration on Aging (AOA)



_______________________________________________________________________




1056. 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 fall of 2004.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            10/00/04

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. 04-13453 Filed 06-25-04; 8:45 am]
BILLING CODE 4150-24-S