[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 26818]]



DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)                          


  



_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Office of the Secretary

21 CFR Ch. I

42 CFR Chs. I-V

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

Regulatory Agenda

AGENCY: Office of the Secretary, HHS.

ACTION: Semiannual agenda.

_______________________________________________________________________

SUMMARY: The Regulatory Flexibility Act of 1980 and Executive Order 
12866 require this semiannual publication that inventories all 
rulemaking actions under development or review by the Department. The 
purpose is to encourage public participation in the regulatory process 
by providing, at as early a stage as possible, summarized information 
about regulatory actions under consideration. Members of the public 
wishing to communicate to the Department their views on the potential 
rulemakings outlined below are invited to do so.

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

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

Dated: April 6, 2005.

 Ann C. Agnew,

Executive Secretary to the Department.

                                  Office of the Secretary--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
821         Safe Harbor for Electronic Prescribing Information Technology.........................    0991-AB39
----------------------------------------------------------------------------------------------------------------


                                    Office of the Secretary--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
822         Shared Risk Exception to the Safe Harbor Provisions...................................    0991-AA91
823         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...............................................................................
824         Safe Harbor for Waiver of Beneficiary Coinsurance and Deductible Amounts for a            0991-AB16
            Medicare SELECT Policy................................................................
825         Clarification of Terms and Application of Program Exclusion Authority for Submitting      0991-AB23
            Claims Containing Excessive Charges...................................................
826         Medicare and State Health Care Programs: Fraud and Abuse; Safe Harbor for Federally       0991-AB38
            Qualified Health Centers Under the Anti-Kickback Statute..............................
----------------------------------------------------------------------------------------------------------------


                                   Office of the Secretary--Long-Term Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
827         Revisions to Regulations Addressing the OIG's Authority To Impose Civil Money             0991-AB03
            Penalties and Assessments.............................................................
828         Claims Collection.....................................................................    0991-AB18
829         Salary Offset.........................................................................    0991-AB19
830         Health Insurance Portability and Accountability Act--Enforcement......................    0991-AB29
831         Revisions to the Waiver Provisions of the Office of Inspector General's (OIG)Exclusion    0991-AB33
            Authorities...........................................................................
----------------------------------------------------------------------------------------------------------------


[[Page 26819]]


                                   Office of the Secretary--Completed Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
832         Office of Inspector General (OIG) Civil Money Penalties Under the Medicare                0991-AB40
            Prescription Drug Discount Card Program...............................................
----------------------------------------------------------------------------------------------------------------


                 Substance Abuse and Mental Health Services Administration--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
833         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
----------------------------------------------------------------------------------------------------------------
834         Mandatory Guidelines for the Federal Workplace Drug Testing Program...................    0930-AA12
----------------------------------------------------------------------------------------------------------------


                         Centers for Disease Control and Prevention--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
835         Amendments to Quality Assurance and Administrative Provision for Approval of              0920-AA04
            Respiratory Protective Devices........................................................
836         Amendments to Self-Contained Breathing Apparatus Requirements for Approval of             0920-AA10
            Respiratory Protective Devices........................................................
837         Control of Communicable Diseases, Interstate and Foreign Quarantine...................    0920-AA12
----------------------------------------------------------------------------------------------------------------


                          Centers for Disease Control and Prevention--Completed Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
838         Possession, Use, and Transfer of Select Agents and Toxins.............................    0920-AA09
839         Establishment of Vaccination Clinics; User Fees for Investigational New Drug (IND)        0920-AA11
            Influenza Vaccine Services and Vaccines...............................................
----------------------------------------------------------------------------------------------------------------


                                   Food and Drug Administration--Prerule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
840         Food Labeling; Prominence of Calories.................................................    0910-AF22
841         Food Labeling; Serving Sizes of Products That Can Reasonably Be Consumed at One Eating    0910-AF23
            Occasion; Updating of Reference Amounts Customarily Consumed; Approaches for
            Recommending Smaller Portion Sizes....................................................
842         Over-the-Counter (OTC) Drug Review--Sunscreen Products................................    0910-AF43
----------------------------------------------------------------------------------------------------------------


                                Food and Drug Administration--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
843         Foreign and Domestic Establishment Registration and Listing Requirements for Human        0910-AA49
            Drugs, Certain Biological Drugs, and Animal Drugs.....................................

[[Page 26820]]

 
844         Medical Devices; Anesthesiology Devices; Proposed Reclassification of Pressure            0910-AC30
            Regulators for Use With Medical Oxygen................................................
845         Submission of Standardized Electronic Study Data From Clinical Studies Evaluating         0910-AC52
            Human Drugs and Biologics.............................................................
846         Medical Gas Containers and Closures; Current Good Manufacturing Practice Requirements.    0910-AC53
847         Food Standards: General Principles and Food Standards Modernization...................    0910-AC54
848         Positron Emission Tomography Drugs; Current Good Manufacturing Practices..............    0910-AC55
849         Reporting Information Regarding Falsification of Data.................................    0910-AC59
850         Health Claims.........................................................................    0910-AF09
851         Content and Format of Labeling for Human Prescription Drugs and Biologics;                0910-AF11
            Requirements for Pregnancy and Lactation..............................................
852         Cochineal Extract and Carmine Label Declaration.......................................    0910-AF12
853         Charging for Investigational Drugs....................................................    0910-AF13
854         Treatment Use of Investigational Drugs................................................    0910-AF14
855         Distribution of Blood Derivatives by Registered Blood Establishments That Qualify as      0910-AF16
            Health Care Entities; PDMA of 1987; PDA of 1992; Policies, Requirements, and
            Administrative Procedures.............................................................
856         Revocation of the Status of Specific Products; Group A Streptococcus..................    0910-AF20
857         Obstetrical and Gynecological Devices; Designation of Special Control for Condoms and     0910-AF21
            Condoms With Spermicidal Lubricant....................................................
858         Blood Initiative--Requirements for Human Blood and Blood Components Intended for          0910-AF25
            Transfusion or for Further Manufacturing Use..........................................
859         Over-the-Counter (OTC) Drug Review--Cough/Cold (Bronchodilator) Products..............    0910-AF32
860         Over-the-Counter (OTC) Drug Review--Cough/Cold (Combination) Products.................    0910-AF33
861         Over-the-Counter (OTC) Drug Review--Cough/Cold (Nasal Decongestant) Products..........    0910-AF34
862         Over-the-Counter (OTC) Drug Review--Internal Analgesic Products.......................    0910-AF36
863         Over-the-Counter (OTC) Drug Review--Labeling of Drug Products for OTC Human Use.......    0910-AF37
864         Over-the-Counter (OTC) Drug Review--Ophthalmic Products...............................    0910-AF39
865         Over-the-Counter (OTC) Drug Review--Weight Control Products...........................    0910-AF45
866         Substances Prohibited From Use in Animal Food or Feed.................................    0910-AF46
867         Over-the-Counter (OTC) Drug Review--Dandruff, Seborrheic Dermatitis, and Psoriasis        0910-AF49
            Products..............................................................................
868         Over-the-Counter (OTC) Drug Review--Skin Bleaching Prodcuts...........................    0910-AF53
869         Over-the-Counter (OTC) Drug Review--Stimulant Drug Products...........................    0910-AF56
870         Designation of New Animal Drugs for Minor Use and Minor Species.......................    0910-AF60
----------------------------------------------------------------------------------------------------------------


                                 Food and Drug Administration--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
871         Requirements on Content and Format of Labeling for Human Prescription Drugs and           0910-AA94
            Biological Products...................................................................
872         Safety Reporting Requirements for Human Drug and Biological Products..................    0910-AA97
873         Applications for FDA Approval To Market a New Drug; Complete Response Letter;             0910-AB34
            Amendments To Unapproved Applications.................................................
874         CGMPs for Blood and Blood Components: Notification of Consignees and Transfusion          0910-AB76
            Recipients Receiving Blood and Blood Components at Increased Risk of Transmitting HCV
            Infection (Lookback)..................................................................
875         Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Dietary         0910-AB88
            Ingredients and Dietary Supplements...................................................
876         Requirements Pertaining to Sampling Services and Private Laboratories Used in             0910-AB96
            Connection With Imported Food.........................................................
877         Additional Safeguards for Children in Clinical Investigations of FDA-Regulated            0910-AC07
            Products..............................................................................
878         Prevention of Salmonella Enteritidis in Shell Eggs....................................    0910-AC14
879         Institutional Review Boards: Registration Requirements................................    0910-AC17
880         Exception From General Requirements for Informed Consent; Request for Comments and        0910-AC25
            Information...........................................................................
881         Medical Devices; Patient Examination and Surgeons' Gloves; Adulteration...............    0910-AC32
882         Amendments to the Performance Standard for Diagnostic X-Ray Systems and Their Major       0910-AC34
            Components............................................................................
883         Toll-Free Number for Reporting Adverse Events on Labeling for Human Drugs.............    0910-AC35
884         Registration of Food and Animal Feed Facilities.......................................    0910-AC40
885         Prior Notice of Imported Food Under the Public Health Security and Bioterrorism           0910-AC41
            Preparedness and Response Act of 2002.................................................
886         Quality Standard Regulation Establishing an Allowable Level for Arsenic in Bottled        0910-AF10
            Water.................................................................................

[[Page 26821]]

 
887         Human Subject Protection; Foreign Clinical Studies Not Conducted Under an                 0910-AF15
            Investigational New Drug Application..................................................
888         Blood Initiative--Revisions to Labeling and Storage Requirements for Blood and Blood      0910-AF26
            Components, Including Source Plasma...................................................
889         Infant Formula: Current Good Manufacturing Practices; Quality Control Procedures;         0910-AF27
            Notification Requirements; Records and Reports........................................
890         Infant Formula Quality Factors........................................................    0910-AF28
891         Over-the-Counter (OTC) Drug Review--Cough/Cold (Antihistamine) Products...............    0910-AF31
892         Over-the-Counter (OTC) Drug Review--Skin Protectant Products..........................    0910-AF42
893         Over-the-Counter (OTC) Drug Review--Vaginal Contraceptive Products....................    0910-AF44
894         Use of Materials Derived From Cattle in Human Food and Cosmetics......................    0910-AF47
895         Recordkeeping Requirements for Human Food and Cosmetics Manufactured From, Processed      0910-AF48
            With, or Otherwise Containing Material From Cattle....................................
896         Over-the-Counter (OTC) Drug Review--Antacid Products..................................    0910-AF52
897         Supplements and Other Changes to Approved New Animal Drug Applications................    0910-AF59
898         Biological Products; Bacterial Vaccines and Toxoids; Implementation of Efficacy Review    0910-AF62
----------------------------------------------------------------------------------------------------------------


                                 Food and Drug Administration--Long-Term Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
899         Investigational New Drugs: Export Requirements for Unapproved New Drug Products.......    0910-AA61
900         Chronic Wasting Disease: Control of Food Products and Cosmetics Derived From Exposed      0910-AC21
            Animal Populations....................................................................
901         Requirements for Submission of In Vivo Bioequivalence Data............................    0910-AC23
902         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.....
903         Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding     0910-AF08
            of Drugs; Revision of Certain Labeling Controls.......................................
904         Over-the-Counter (OTC) Drug Review--External Analgesic Products.......................    0910-AF35
905         Over-the-Counter (OTC) Drug Review--Laxative Drug Products............................    0910-AF38
906         Over-the-Counter (OTC) Drug Review--Oral Health Care Products.........................    0910-AF40
907         Over-the-Counter (OTC) Drug Review--Overindulgence in Food and Drink Products.........    0910-AF51
908         Use of Materials Derived From Cattle in Medical Products Intended for Use in Humans       0910-AF54
            and Drugs Intended for Use in Ruminants...............................................
909         Label Requirement for Food That Has Been Refused Admission Into the United States.....    0910-AF61
----------------------------------------------------------------------------------------------------------------


                                 Food and Drug Administration--Completed Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
910         Current Good Tissue Practice for Human Cell, Tissue, and Cellular and Tissue-Based        0910-AB28
            Product Establishments; Inspection and Enforcement....................................
911         Establishment and Maintenance of Records Pursuant to the Public Health Security and       0910-AC39
            Bioterrorism Preparedness and Response Act of 2002 (Completion of a Section 610
            Review)...............................................................................
912         Food Labeling: Food Allergen Ingredient Labeling......................................    0910-AF07
913         Use of Ozone-Depleting Substances: Removal of Essential Use Designation; Albuterol....    0910-AF18
914         Requirements for Human and Animal Medical Products Manufactured From, Processed With,     0910-AF55
            or Otherwise Containing Material From Cattle..........................................
----------------------------------------------------------------------------------------------------------------


[[Page 26822]]


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


                         Health Resources and Services Administration--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
921         Interim Final Rule for the Smallpox Emergency Personnel Protection Program: Smallpox      0906-AA60
            (Vaccinia) Vaccine Injury Table.......................................................
922         Smallpox Vaccine Injury Compensation Program: Administrative Implementation...........    0906-AA61
923         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
----------------------------------------------------------------------------------------------------------------
924         National Practitioner Data Bank for Adverse Information on Physicians and Other Health    0906-AA57
            Care Practitioners: Reporting Adverse and Negative Actions............................
925         Operation of the Organ Procurement and Transplantation Network (OPTN).................    0906-AA63
----------------------------------------------------------------------------------------------------------------


                         Health Resources and Services Administration--Completed Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
926         National Vaccine Injury Compensation Program; Revisions and Additions to the Vaccine      0906-AA66
            Injury Table..........................................................................
----------------------------------------------------------------------------------------------------------------


                                   Indian Health Service--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
927         Section 506--Limitation on Charges for Services Furnished by Medicare Participating       0917-AA07
            Inpatient Hospital to Indians.........................................................
----------------------------------------------------------------------------------------------------------------


                               National Institutes of Health--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
928         Undergraduate Scholarship Program Regarding Professions Needed by the National            0925-AA10
            Institutes of Health (NIH)............................................................
929         National Institutes of Health AIDS Research Loan Repayment Program....................    0925-AA32
930         National Institutes of Health Extramural Loan Repayment Program for Clinical              0925-AA33
            Researchers...........................................................................
931         National Institutes of Health Pediatric Research Loan Repayment Program...............    0925-AA34
932         National Institutes of Health Loan Repayment Program for Health Disparities Research..    0925-AA35

[[Page 26823]]

 
933         National Institutes of Health Clinical Research Loan Repayment Program for Individuals    0925-AA36
            From Disadvantaged Backgrounds........................................................
934         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
----------------------------------------------------------------------------------------------------------------
935         National Institutes of Health Loan Repayment Program for Research Generally...........    0925-AA18
936         National Institutes of Health Training Grants.........................................    0925-AA28
937         Standards for a National Chimpanzee Sanctuary System..................................    0925-AA31
----------------------------------------------------------------------------------------------------------------


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


                              Office of Public Health and Science--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
939         Public Health Service Policies on Research Misconduct.................................    0940-AA04
940         Human Subjects Protection Regulations: Institutional Review Boards Registration           0940-AA06
            Requirements..........................................................................
941         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
----------------------------------------------------------------------------------------------------------------
942         Public Health Service Standards for the Protection of Research Misconduct                 0940-AA01
            Whistleblowers........................................................................
943         Human Subjects Protection Regulations: Training and Ed. Requirements for Institutional    0940-AA08
            Officials, Institutional Review Board Members and Staff, Human Protections
            Administrators, and Investigators.....................................................
----------------------------------------------------------------------------------------------------------------


                          Centers for Medicare & Medicaid Services--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
944         Home Health Agency (HHA) Conditions of Participation (CoPs) (CMS-3819-P)..............    0938-AG81
945         Hospice Care--Conditions of Participation (CMS-3844-P)................................    0938-AH27
946         Standard Unique National Health Plan Identifier (CMS-6017-P)..........................    0938-AH87
947         Appeals of Carrier Determinations That a Supplier Fails To Meet the Requirements for      0938-AI49
            Medicare Billing Privileges (CMS-6003-P2).............................................
948         Rural Health Clinics: Amendments to Participation Requirements and Payment Provisions     0938-AJ17
            and Establishment of a Quality Assessment and Improvement Program (CMS-1910-P2).......
949         Supplier Standards for Home Oxygen, Therapeutic Shoes, and Home Nutrition Therapy (CMS-   0938-AJ98
            6010-P)...............................................................................
950         Standards for Electronic Health Care Claim Attachments (CMS-0050-P)...................    0938-AK62

[[Page 26824]]

 
951         Use of Restraints and Seclusion in Medicare and Medicaid Participating Facilities That    0938-AL26
            Provide Inpatient or Residential Care (CMS-2130-P)....................................
952         Revisions to Conditions for Coverage for Ambulatory Surgical Centers (CMS-3887-P).....    0938-AL80
953         Modifications to Electronic Transactions and Code Sets (CMS-0009-P)...................    0938-AM50
954         Requirements for Long-Term Care Facilities: Hospice Services (CMS-3140-P).............    0938-AM87
955         Enhanced DSH Treatment for Certain Hospitals (CMS-2198-P).............................    0938-AN09
956         Prior Determination Process for Certain Items and Services (CMS-6024-P)...............    0938-AN10
957         Competitive Acquisition for Certain Durable Medical Equipment (DME), Prosthetics,         0938-AN14
            Orthotics, and Supplies (CMS-1270-P)..................................................
958         Revisions to HIPAA Code Sets (CMS-0013-P).............................................    0938-AN25
959         Payment for Clinical Laboratory Tests (CMS-1494-P)....................................    0938-AN26
960         Termination of Non-Random Prepayment Medical Review (CMS-6022-P)......................    0938-AN31
961          Limitation on Recoupment of Overpayments (CMS-6025-P)................................    0938-AN42
962         Prospective Payment System for Inpatient Rehabilitation Facilities for FY 2006 (CMS-      0938-AN43
            1290-P)...............................................................................
963         Home Health Prospective Payment System Rate Update for Calendar Year 2006 (CMS-1301-P)    0938-AN44
964         Changes to the Hospital Outpatient Prospective Payment System and Calendar Year 2006      0938-AN46
            Payment Rates (CMS-1501-P)............................................................
965         Revised Civil Money Penalties, Assessments, Exclusions, and Related Appeals Procedures    0938-AN48
            (CMS-6019-P)..........................................................................
966         Changes to the Hospital Inpatient Prospective Payment System and FY 2006 Rates (CMS-      0938-AN57
            1500-P)...............................................................................
967         Special Payment Provisions and Standards for Suppliers of Custom Fabricated Orthotics     0938-AN63
            and Prosthetics (CMS-6012-P)..........................................................
968         Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities--      0938-AN65
            Update for FY 2006 (CMS-1282-P).......................................................
969         Physicians' Referrals to Health Care Entities With Which They Have Financial              0938-AN69
            Relationships; Communitywide Health Information Systems and Electronic Prescribling
            Exception (CMS-1303-P)................................................................
970         National Plan and Provider Enumeration System (NPPES) Data Dissemination (CMS-6060-N).    0938-AN71
971         Medicare Integrity Program, Fiscal Intermediary and Carrier Functions, and Conflict of    0938-AN72
            Interest Requirements (CMS-6030-P2)...................................................
972         Changes to the Disclosure of Information Requirements for Quality Improvement             0938-AN73
            Organizations (CMS-3156-P)............................................................
973         Home Health Payment System Rate Update for Calendar Year 2007 (CMS-1304-P)............    0938-AN76
974         Inpatient Psychiatric Facility Prospective Payment System--Update for 2006 (CMS-1306-     0938-AN82
            P)....................................................................................
975         Revisions to Payment Policies Under the Physician Fee Schedule for Calendar Year 2006     0938-AN84
            (CMS-1502-P)..........................................................................
----------------------------------------------------------------------------------------------------------------


                           Centers for Medicare & Medicaid Services--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
976         Requirements for Establishing and Maintaining Medicare Billing Privileges (CMS-6002-F)    0938-AH73
977         Hospital Conditions of Participation: Laboratory Services (CMS-3014-IFC)..............    0938-AJ29
978         Medicare Hospice Care Amendments (CMS-1022-F).........................................    0938-AJ36
979         Conditions for Coverage of Power Mobility Devices, Including Powered Wheelchairs and      0938-AM74
            Power-Operated Vehicles Scooter (CMS-3017-IFC)........................................
980         Nondiscrimination In Post-Hospital Referral to Home Health Agencies and Other Entities    0938-AN19
            (CMS-1224-F)..........................................................................
981         Update of the List of Covered Procedures for Ambulatory Surgical Centers for 2005 (CMS-   0938-AN23
            1478-IFC).............................................................................
982         Medicare Secondary Payer Amendments (CMS-6272-IFC)....................................    0938-AN27
983         Prospective Payment System for Long Term Care Hospitals: Annual Payment Rate Updates      0938-AN28
            and Policy Changes for 2006 (CMS-1483-F)..............................................
984         Development of New Standards for Medigap Policies (CMS-4087-FN).......................    0938-AN50
985         Fiscal Year 2006 SCHIP Allotments (CMS-2219-N)........................................    0938-AN56
986         All Provider Bad Debt Payment (CMS-1126-F)............................................    0938-AN75
987         State Children's Health Insurance Program (SCHIP); Redistribution of Unexpended SCHIP     0938-AN78
            Funds From the Appropriation for Fiscal Year (FY) 2002 (CMS-2230-FN)..................
988         Extending Sunset Date for the Interim Final Regulation on Mental Health Parity (CMS-      0938-AN80
            4094-F3)..............................................................................
989         Application of Inherent Reasonableness to All Medicare Part B Services (Other than        0938-AN81
            Physician Services) (CMS-1908-F)......................................................
990         Electronic Submission of Cost Reports: Revision to Cost Reporting Period (CMS-1199-       0938-AN87
            IFC)..................................................................................
----------------------------------------------------------------------------------------------------------------


[[Page 26825]]


                           Centers for Medicare & Medicaid Services--Long-Term Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
991         End Stage Renal Disease (ESRD) Conditions for Coverage (CMS-3818-F) (Section 610          0938-AG82
            Review)...............................................................................
992         Hospital Conditions of Participation: Requirements for Approval and Reapproval of         0938-AH17
            Transplant Centers To Perform Organ Transplants (CMS-3835-F)..........................
993         Medicare Outcome and Assessment Information Set (OASIS) Data Reporting Requirements       0938-AJ10
            (CMS-3006-F)..........................................................................
994         Use of Restraint and Seclusion in Residential Treatment Facilities Providing Inpatient    0938-AJ96
            Psychiatric Services to Individuals Under Age 21 (CMS-2065-F).........................
995         Physicians' Referrals to Health Care Entities With Which They Have Financial              0938-AK67
            Relationships (CMS-1810-F)............................................................
996         Organ Procurement Organization Conditions for Coverage (CMS-3064-F)...................    0938-AK81
997         Provider Reimbursement Determinations and Appeals (CMS-1727-F)........................    0938-AL54
998         Health Coverage Portability: Tolling Certain Time Periods and Interactions With Family    0938-AL88
            and Medical Leave Act (CMS-2158-F)....................................................
999         Electronic Medicare Claims Submission (CMS-0008-F)....................................    0938-AM22
1000        Requirements for Long-Term Care Facilities; Nursing Services; Posting of Nurse            0938-AM55
            Staffing Information (CMS-3121-F).....................................................
1001        Revisions to the Appeals Process for Initial Claim Determinations (CMS-4064-IFC)......    0938-AM73
1002        Hospital Conditions of Participation: Requirements for History and Physical               0938-AM88
            Examinations; Authentication of Verbal Orders; Securing Medications; and Post-
            Anesthesia Evaluations (CMS-3122-P2)..................................................
1003        Revised Civil Money Penalties, Assessments, Exclusions, and Related Appeals Procedures    0938-AM98
            (CMS-6146-F)..........................................................................
1004        Payment for Respiratory Assist Devices With Bi-Level Capability and a Back-Up Rate        0938-AN02
            (CMS-1167-F)..........................................................................
1005        Evaluation Criteria and Standards for Quality Improvement Program Contracts (CMS-3142-    0938-AN13
            FN)...................................................................................
1006        Medicare Ambulance Fee Schedule Update (CMS-1492-F)...................................    0938-AN24
1007        Nondiscrimination in Health Coverage and Wellness Plans in the Group Market (CMS-4081-    0938-AN29
            F)....................................................................................
1008        Hospital Conditions of Participation: Patients' Rights (CMS-3018-F)...................    0938-AN30
1009        Federal Enforcement in Group and Individual Health Insurance Markets (CMS-4091-F).....    0938-AN35
1010        Fire Safety Requirements for Certain Health Care Facilities; Alcohol-Based Hand           0938-AN36
            Sanitizer Amendment (CMS-3145-IFC)....................................................
1011        Medicare Modernization Act; Electronic Prescribing (CMS-0011-F).......................    0938-AN49
1012        Medicare Part B Competitive Acquisition of Outpatient Drugs and Biologicals (CMS-1325-    0938-AN58
            F)....................................................................................
1013        Group Market Health Insurance Reform: Guaranteed Availability, Guaranteed                 0938-AN60
            Renewability, Disclosures to Small Employers (CMS-4102-F).............................
1014        Individual Market Health Insurance Reform: Portability From Group to Individual           0938-AN61
            Coverage; Federal Rules for Access in the Individual Market; State Alternative
            Mechanisms to Federal Rules (CMS-4103-F)..............................................
1015        Revisions to the Oversight and Validation Program for Accrediting Organizations           0938-AN62
            Approved for Deeming Authority (CMS-2255-P)...........................................
1016        Payment Error Rate Measurement (PERM) Program (CMS-6026-F)............................    0938-AN77
1017        Fire Safety Requirements for Long-Term Care Facilities: Sprinkler Systems (CMS-3191-P)    0938-AN79
1018        Program for All-Inclusive Care for the Elderly (PACE): Program Revisions (CMS-1201-F).    0938-AN83
----------------------------------------------------------------------------------------------------------------


                           Centers for Medicare & Medicaid Services--Completed Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
1019        Health Coverage Portability for Group Health Plans and Group Health Insurance Issuers     0938-AL43
            (CMS-2151-F)..........................................................................
1020        Prospective Payment System for Inpatient Psychiatric Facilities for FY 2004 (CMS-1213-    0938-AL50
            F)....................................................................................
1021        Request for Information on Benefit-Specific Waiting Periods (CMS-2150-NC).............    0938-AL64
1022        Revisions to the Medicare Appeals Process (CMS-4004-FC)...............................    0938-AL67
1023        DMERC Service Areas and Related Matters (CMS-1219-F)..................................    0938-AL76
1024        Procedures for Maintaining Code Lists in the Negotiated National Coverage                 0938-AM36
            Determinations for Clinical Diagnostic Laboratory Services (CMS-3119-FN)..............
1025        Changes to the Hospital Outpatient Prospective System and Calendar Year 2005 Payment      0938-AM75
            Rates (CMS-1427-FC)...................................................................
1026        Revisions to Payment Policies Under the Physician Fee Schedule for Calendar Year 2005     0938-AM90
            (CMS-1429-FC).........................................................................
1027        Physician Referral for Nuclear Medicine Services and Supplies (CMS-1261-P)............    0938-AN04
1028        Medicare Advantage Program--Title II (CMS-4069-F).....................................    0938-AN06
1029        Medicare Drug Benefit Effective Calendar Year 2006--Title I (CMS-4068-F)..............    0938-AN08
1030        Schedule for Publishing Medicare Final Regulations After a Proposed or Interim Final      0938-AN12
            Regulation (CMS-9026-N)...............................................................
1031        Modifications to Managed Care Rules (CMS-4041-IFC)....................................    0938-AN38
1032        Furnishing Hospitals With Information To Compute the Disproportionate Share Hospital      0938-AN52
            Formula (CMS-1283-P)..................................................................

[[Page 26826]]

 
1033        End Stage Renal Disease (ESRD) Composite Rate Exception (CMS-1278-P)..................    0938-AN53
1034        Time Limitation on Recordkeeping Requirements Under the Drug Rebate Program (CMS-2175-    0938-AN55
            F)....................................................................................
1035        Recognition of NAIC Standards for Regulation of Medicare Supplemental Insurance (CMS-     0938-AN66
            4080-N)...............................................................................
1036        Quality Improvement Organizations Contracts: Solicitation of Statements of Interest       0938-AN67
            From In-State Organizations--Alaska, Hawaii, Idaho, Maine, South Carolina, Vermont,
            and Wyoming (CMS-3155-N)..............................................................
1037        Procedures for the Submission of Non-Privacy Administrative Simplification Complaints     0938-AN68
            Under the Health Insurance Portability and Accountability Act of 1996 (CMS-0014-N)....
1038        Clinical Laboratory Improvement Amendments of 1988; Continuance of Exemption of           0938-AN70
            Laboratories Licensed by the State of Washington (CMS-2207-N).........................
----------------------------------------------------------------------------------------------------------------


                          Administration for Children and Families--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
1039        Safeguarding Child Support and Expanded Federal Parent Locator Services (FPLS)            0970-AC01
            Information...........................................................................
1040        Developmental Disabilities and Bill of Rights Act.....................................    0970-AC07
1041        Administrative Cost Sharing Under TANF................................................    0970-AC15
1042        Care and Placement of Unaccompanied Alien Children....................................    0970-AC20
1043        Chafee National Youth in Transition Database..........................................    0970-AC21
1044        Medical Support.......................................................................    0970-AC22
----------------------------------------------------------------------------------------------------------------


                           Administration for Children and Families--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
1045        Administrative Costs for Children in Title IV-E Foster Care...........................    0970-AC14
1046        Head Start Transportation.............................................................    0970-AC16
1047        Child Care and Development Fund State Match Provisions................................    0970-AC18
1048        Reasonable Quantitative Standard for Review and Adjustment of Child Support Orders....    0970-AC19
----------------------------------------------------------------------------------------------------------------


                                   Administration on Aging--Completed Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
1049        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)



_______________________________________________________________________




821. [bull] SAFE HARBOR FOR ELECTRONIC PRESCRIBING INFORMATION 
TECHNOLOGY

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

Unfunded Mandates: Undetermined

Legal Authority: PL 100-93, sec 14(a); PL 108-173, sec 101(a)(4)(D)(6)

CFR Citation: 42 CFR 1001

Legal Deadline: None

Abstract: This rule would establish a safe harbor with respect to the 
provision of nonmonetary remuneration--in the form of hardware, 
software, or information technology and training services--necessary 
and used solely to receive and transmit electronic prescription 
information in accordance with section 1860-D of the Social Security 
Act.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            08/00/05
NPRM Comment Period End         10/00/05

[[Page 26827]]

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

RIN: 0991-AB39
_______________________________________________________________________


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


Office of the Secretary (OS)



_______________________________________________________________________




822. SHARED RISK EXCEPTION TO THE SAFE HARBOR PROVISIONS

Priority: Substantive, Nonsignificant

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

CFR Citation: 42 CFR 1001

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

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

ANPRM                           05/23/97                    62 FR 28410
ANPRM Comment Period End        06/09/97
Interim Final Rule              11/19/99                    64 FR 63504
Final Action                    10/00/05

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

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




823. 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                    09/00/05

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses, Governmental Jurisdictions, 
Organizations

Government Levels Affected: Federal, Local, State, Tribal

Agency Contact: Robinsue Frohboese, Principal Deputy Director, Office 
for Civil Rights, Department of Health and Human Services, Office of 
the Secretary, 200 Independence Avenue SW., Washington, DC 20202
Phone: 202 619-0403

RIN: 0991-AB10
_______________________________________________________________________




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

Priority: Substantive, Nonsignificant

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

CFR Citation: 42 CFR 1001

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

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

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

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

RIN: 0991-AB16

[[Page 26828]]

_______________________________________________________________________




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

Priority: Substantive, Nonsignificant

Legal Authority: Social Security Act, sec 112B(6); Social Security Act, 
sec 112B(6)(A)

CFR Citation: 42 CFR 1001

Legal Deadline: None

Abstract: This rule would amend the Office of Inspector General's 
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                    10/00/05

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

RIN: 0991-AB23
_______________________________________________________________________




826. [bull] MEDICARE AND STATE HEALTH CARE PROGRAMS: FRAUD AND ABUSE; 
SAFE HARBOR FOR FEDERALLY QUALIFIED HEALTH CENTERS UNDER THE ANTI-
KICKBACK STATUTE

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

Legal Authority: PL 100-93, sec 14(a); PL 108-173, sec 431

CFR Citation: 42 CFR 1001

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

Abstract: This rule will set forth standards for the new anti-kickback 
safe harbor addressing remuneration between federally qualified health 
centers and certain providers where significant community benefit 
exits.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              06/00/05
Interim Final Rule Comment 
Period End                      08/00/05

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

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

Related RIN: Related to 0991-AB06, Related to 0991-AA91
RIN: 0991-AB38
_______________________________________________________________________


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


Office of the Secretary (OS)



_______________________________________________________________________




827. 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, 330 Independence Avenue SW., Washington, DC 20201
Phone: 202 619-0089

RIN: 0991-AB03
_______________________________________________________________________




828. CLAIMS COLLECTION

Priority: Substantive, Nonsignificant

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

CFR Citation: 45 CFR 30

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

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

Regulatory Flexibility Analysis Required: No

[[Page 26829]]

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Jeffrey S. Davis, Associate General Counsel, Department 
of Health and Human Services, Office of the Secretary, Office of the 
General Counsel, Room 5362, HHS Cohen Building, Room 4760, 330 
Independence Avenue SW., Washington, DC 20201
Phone: 202 619-0150

RIN: 0991-AB18
_______________________________________________________________________




829. SALARY OFFSET

Priority: Substantive, Nonsignificant

Unfunded Mandates: Undetermined

Legal Authority: 5 USC 5514; 5 CFR 550

CFR Citation: 45 CFR 33

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            07/13/04
Final Action                     To Be                       Determined

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Jeffrey S. Davis, Associate General Counsel, Department 
of Health and Human Services, Office of the Secretary, Office of the 
General Counsel, Room 5362, HHS Cohen Building, Room 4760, 330 
Independence Avenue SW., Washington, DC 20201
Phone: 202 619-0150

RIN: 0991-AB19
_______________________________________________________________________




830. HEALTH INSURANCE PORTABILITY AND ACCOUNTABILITY ACT--ENFORCEMENT

Priority: Other Significant

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

CFR Citation: 45 CFR 160, subparts C to E

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            04/18/05                    70 FR 20224
Final Action                    08/00/06

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
_______________________________________________________________________




831. REVISIONS TO THE WAIVER PROVISIONS OF THE OFFICE OF INSPECTOR 
GENERAL'S (OIG)EXCLUSION AUTHORITIES

Priority: Substantive, Nonsignificant

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

CFR Citation: 42 CFR 1001

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                             To Be                       Determined

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: Federal

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

RIN: 0991-AB33
_______________________________________________________________________


Department of Health and Human Services (HHS)         Completed Actions


Office of the Secretary (OS)



_______________________________________________________________________




832. [bull] OFFICE OF INSPECTOR GENERAL (OIG) CIVIL MONEY PENALTIES 
UNDER THE MEDICARE PRESCRIPTION DRUG DISCOUNT CARD PROGRAM

Priority: Substantive, Nonsignificant

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

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 that knowingly engage 
in false or misleading marketing practices, overcharge program 
enrollees or misuse transitional assistance funds under the Medicare 
prescription drug discount card program.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              05/19/04                    69 FR 28842
Interim Final Rule Comment 
Period End                      07/19/04
Final Rule                      12/14/04                    69 FR 74451

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

[[Page 26830]]

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

RIN: 0991-AB40
_______________________________________________________________________


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


Substance Abuse and Mental Health Services Administration (SAMHSA)



_______________________________________________________________________




833. 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                            06/00/05

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: State

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

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

RIN: 0930-AA10
_______________________________________________________________________


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


Substance Abuse and Mental Health Services Administration (SAMHSA)



_______________________________________________________________________




834. 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                    10/00/05

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)       Proposed Rule Stage


Centers for Disease Control and Prevention (CDC)



_______________________________________________________________________




835. 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                            08/00/05

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected:  Businesses

Government Levels Affected: None

[[Page 26831]]

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
_______________________________________________________________________




836. [bull] AMENDMENTS TO SELF-CONTAINED BREATHING APPARATUS 
REQUIREMENTS FOR APPROVAL OF RESPIRATORY PROTECTIVE DEVICES

Priority: Other Significant

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

CFR Citation: 42 CFR 84

Legal Deadline: None

Abstract: NIOSH plans to modify sections of 42 CFR part 84 concerning 
performance testing and other specifications for the certification of 
closed-circuit, self-contained breathing apparatus. These respiratory 
protective devices are used in emergencies for the protection of miners 
and workers in other industries.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/00/05

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected:  Businesses

Government Levels Affected: None

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

RIN: 0920-AA10
_______________________________________________________________________




837. [bull] CONTROL OF COMMUNICABLE DISEASES, INTERSTATE AND FOREIGN 
QUARANTINE

Priority: Economically Significant. Major under 5 USC 801.

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

Legal Authority: Not Yet Determined

CFR Citation: 42 CFR 70; 42 CFR 71

Legal Deadline: None

Abstract: By statute, the Secretary of Health and Human Services (HHS) 
has broad authority to prevent introduction, transmission, and spread 
of communicable diseases from foreign countries into the United States 
and from one State or possession into another. Quarantine regulations 
are divided into two parts: part 71 dealing with foreign arrivals and 
part 70 dealing with interstate matters. The Secretary has delegated 
the authority to prevent the introduction of diseases from foreign 
countries to the Director, CDC. Interstate authority is split between 
CDC and the Food and Drug Administration (FDA), with CDC delegated 
interstate authority as it pertains to humans. CDC maintains quarantine 
stations at 8 major airports with quarantine inspectors who respond to 
reports of diseases from carriers. According to the statutory scheme, 
the President of the United States determines through Executive order 
which diseases may subject individuals to quarantine. The current 
disease list, which was last updated in April 2003, includes cholera, 
diphtheria, tuberculosis, plague, smallpox, yellow fever, viral 
hemorrhagic fevers, and Severe Acute Respiratory Syndrome (SARS).

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            11/00/05

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Ram Koppaka M.D., Ph.D, Department of Health and Human 
Services, Centers for Disease Control and Prevention, MS-E-03, 1600 
Clifton Road, Atlanta, GA 30333
Phone: 404 498-2308

RIN: 0920-AA12
_______________________________________________________________________


Department of Health and Human Services (HHS)         Completed Actions


Centers for Disease Control and Prevention (CDC)



_______________________________________________________________________




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

Priority: Other Significant

CFR Citation: 42 CFR 72; 42 CFR 72.6

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    03/18/05                    70 FR 13294

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Mark Hemphill
Phone: 404 498-2255

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




839. [bull] ESTABLISHMENT OF VACCINATION CLINICS; USER FEES FOR 
INVESTIGATIONAL NEW DRUG (IND) INFLUENZA VACCINE SERVICES AND VACCINES

Priority: Other Significant

Legal Authority: Not Yet Determined

CFR Citation: 42 CFR 70

Legal Deadline: None

Abstract: We are amending 42 CFR part 70 to establish vaccination 
clinics and a user fee connection with the administration of 
vaccination services and vaccine. The Secretary of HHS announced the 
purchase of 1.2 million doses of GlaxoSmithKline (GSK) influenza 
vaccine, Fluarix, for distribution to areas most in need as determined 
by State public health authorities. The Fluartix vaccine has been 
approved in seventy-eight foreign countries, and FDA has recently 
reviewed extensive manufacturing and summary clinical information and 
conducted an inspection of the GSK manufacturing facility in Germany to 
determine that this vaccine, although not licensed in the United 
States, is suitable for use under an

[[Page 26832]]

Investigational New Drug application (IND).

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              01/25/05                     70 FR 3490

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Lisa Rotz, Department of Health and Human Services, 
Centers for Disease Control and Prevention, MS-C-19, 1600 Clifton Road, 
Atlanta, GA 30333
Phone: 404 639-0153

RIN: 0920-AA11
_______________________________________________________________________


Department of Health and Human Services (HHS)             Prerule Stage


Food and Drug Administration (FDA)



_______________________________________________________________________




840. FOOD LABELING; PROMINENCE OF CALORIES

Priority: Other Significant

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 issued on April 4, 
2005, an advance notice of proposed rulemaking (ANPRM) in its efforts 
to combat the Nation's obesity problem. The ANPRM requested comments on 
ways to give more prominence to ``calories'' on the food label.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

ANPRM                           04/04/05                    70 FR 17008
ANPRM Comment Period End        06/20/05
NPRM                             To Be                       Determined

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Agency Contact: Jill Kevala, Chemist, Department of Health and Human 
Services, Food and Drug Administration, HFS-830, Center for Food Safety 
and Applied Nutrition, 5100 Paint Branch Parkway, College Park, MD 
20740
Phone: 301 436-1450
Fax: 301 436-2636
Email: [email protected]

RIN: 0910-AF22
_______________________________________________________________________




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

Priority: Other Significant

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

CFR Citation: 21 CFR 101.9(b); 21 CFR 101.12; 21 CFR 101.60(b)

Legal Deadline: None

Abstract: In response to the Report of the Working Group on Obesity 
that FDA issued on March 12, 2004, the agency issued on April 4, 2005, 
an advance notice of proposed rulemaking (ANPRM) in its efforts to 
combat the Nation's obesity problem. The ANPRM requested 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                           04/04/05                    70 FR 17010
ANPRM Comment Period End        06/20/05
NPRM                             To Be                       Determined

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: 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
_______________________________________________________________________




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

Priority: Routine and Frequent

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

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

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

ANPRM (Sunscreen and Insect 
Repellent)                      10/00/05
NPRM (UVA/UVB)                  12/00/05

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Gerald M. Rachanow, Regulatory Counsel, Division of 
Over-the-Counter Drug Products, Department of Health and Human 
Services, Food and Drug Administration, HFD-560, Center for Drug 
Evaluation and Research, 5600 Fishers Lane, HFD-560, Rockville, MD 
20857

[[Page 26833]]

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)



_______________________________________________________________________




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

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 reorganize, consolidate, clarify, and 
modify current regulations at 21 CFR part 207 concerning who must 
register establishments and list human drugs, certain biological drugs, 
and animal drugs. These regulations contain information on when, how, 
and where to register drug establishments and list drugs, and what 
information must be submitted for initial registration and listing and 
for changes to registration and listing. The proposed rule would 
require that this information be submitted via the Internet into the 
FDA registration and listing database, instead of the current 
requirement to submit the information to FDA on paper forms. The 
proposed rule would also require that the NDC number appear on drug 
labels. In addition, FDA would assign the NDC number to newly listed 
drugs and take other steps to minimize the use of inaccurate NDC 
numbers on drug labels.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/00/05

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
_______________________________________________________________________




844. 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

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                            12/00/05

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Federalism:  Undetermined

Agency Contact: Myrna Hanna, Regulations Staff, Department of Health 
and Human Services, Food and Drug Administration, Center for Devices 
and Radiological Health, HFZ-215, 1350 Piccard Drive, Rockville, MD 
20850
Phone: 301 827-2971
Fax: 301 594-4765
Email: [email protected]

RIN: 0910-AC30
_______________________________________________________________________




845. 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.

[[Page 26834]]

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            10/00/05

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: Undetermined

Agency Contact: Nicole K. Mueller, Regulatory Counsel, Department of 
Health and Human Services, Food and Drug Administration, Room 3037, 
(HFD-7), Center for Drug Evaluation and Research, 5515 Security Lane, 
Suite 1101 (HFD-7), Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 594-6197
Email: [email protected]

RIN: 0910-AC52
_______________________________________________________________________




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

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

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

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

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/00/05

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: None

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

RIN: 0910-AC53
_______________________________________________________________________




847. 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 9 CFR part 319 be submitted in accordance 
with the general principles. Conversely, the agencies may find 
deficient a petition to establish, revise, or eliminate a food standard 
that does not follow these general principles.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

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

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: Undetermined

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

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




848. POSITRON EMISSION TOMOGRAPHY DRUGS; CURRENT GOOD MANUFACTURING 
PRACTICES

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

Unfunded Mandates: Undetermined

Legal Authority: PL 105-115, sec 121

CFR Citation: 21 CFR 212

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

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

[[Page 26835]]

that reflect the unique characteristics of PET drugs.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            05/00/05

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
_______________________________________________________________________




849. REPORTING INFORMATION REGARDING FALSIFICATION OF DATA

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

Unfunded Mandates: Undetermined

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

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

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/00/05

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
_______________________________________________________________________




850. 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                            12/00/05

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
_______________________________________________________________________




851. 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                            12/00/05

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected:  Businesses

[[Page 26836]]

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
_______________________________________________________________________




852. COCHINEAL EXTRACT AND CARMINE LABEL DECLARATION

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

Legal Authority: 21 USC 379e(b)

CFR Citation: 21 CFR 73.100(d); 21 CFR 73.1100(c); 21 CFR 73.2087(c); 
21 CFR 101.22(k); 21 CFR 201.100(b); 21 CFR 201.324

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/00/05

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Mical E Honigfort, Consumer Safety Officer, Department 
of Health and Human Services, Food and Drug Administration, HFS-265, 
5100 Paint Branch Parkway, College Park, MD 20740
Phone: 301 436-1278
Fax: 301-436-2972
Email: [email protected]

RIN: 0910-AF12
_______________________________________________________________________




853. 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                            09/00/05

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected:  Businesses

Government Levels Affected: Undetermined

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

RIN: 0910-AF13
_______________________________________________________________________




854. TREATMENT USE OF INVESTIGATIONAL DRUGS

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

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

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

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/00/05

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected:  Businesses

Government Levels Affected: Undetermined

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

RIN: 0910-AF14
_______________________________________________________________________




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

Priority: Substantive, Nonsignificant

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

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

Legal Deadline: None

Abstract: FDA is proposing to amend certain limited provisions of the 
implementing regulations of the Prescription Drug Marketing Act (PDMA) 
of 1987, as modified by the Prescription Drug Amendments (PDA) of 1992 
and the FDA Modernization Act of 1997. Certain provisions of that final 
rule that published on December 3, 1999, (64 FR 67720), do not allow a 
registered blood establishment that

[[Page 26837]]

provides health care services related to its activities as a blood 
establishment to concurrently distribute blood derivatives. The 
effective date of those provisions of that rule is December 1, 2006, as 
published on February 23, 2004, (69 FR 8105). FDA is amending the final 
rule to allow a registered blood establishment that concurrently 
provides health care services to also distribute blood derivatives.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/00/05

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

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

Agency Contact: Kathleen E. Swisher, Supervisory Regulatory Counsel, 
Department of Health and Human Services, Food and Drug Administration, 
Center for Biologics Evaluation and Research, 1401 Rockville Pike, 
Suite 200N, (HFM-17), Rockville, MD 20852
Phone: 301 827-6210
Fax: 301 827-9434

RIN: 0910-AF16
_______________________________________________________________________




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

Priority: Info./Admin./Other

Legal Authority: 42 USC 262

CFR Citation: 21 CFR 610.19

Legal Deadline: None

Abstract: FDA is issuing a direct final rule and companion proposed 
rule to revoke 21 CFR 610.19, Status of specific products; Group A 
streptococcus. The current regulation was based on the panel report for 
bacterial vaccines with ``No U.S. Standard of Potency.'' The vaccines 
had been licensed by the National Institutes of Health prior to 1972, 
when regulatory authority over these vaccines was transferred to FDA. 
The regulation prohibits the use of Group A streptococcus organisms and 
derivatives of Group A streptococcus as ingredients in Bacterial 
Vaccines and Bacterial Antigens with ``No U.S. Standard of Potency.'' 
The regulation was written to apply to a group of products that are no 
longer on the market, namely, streptococcus vaccines and antigens with 
``No U.S. Standard of Potency'' that were not purified. 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                            09/00/05
Direct Final Rule               09/00/05

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
_______________________________________________________________________




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

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

Legal Authority: 21 USC 360c

CFR Citation: 21 CFR 884.5300; 21 CFR 884.5310

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            05/00/05

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected:  Businesses

Government Levels Affected: None

Federalism:  Undetermined

Agency Contact: Myrna Hanna, Regulations Staff, Department of Health 
and Human Services, Food and Drug Administration, Center for Devices 
and Radiological Health, HFZ-215, 1350 Piccard Drive, Rockville, MD 
20850
Phone: 301 827-2971
Fax: 301 594-4765
Email: [email protected]

RIN: 0910-AF21
_______________________________________________________________________




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

Priority: Other Significant

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

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

Legal Deadline: None

Abstract: The Food and Drug Administration (FDA) is proposing to amend 
the biologics regulations by removing, revising, or updating specific 
regulations applicable to blood, blood components, Source Plasma, and 
Source Leukocytes to be more

[[Page 26838]]

consistent with current practices and to remove unnecessary or outdated 
requirements. This action is based on FDA's comprehensive review of the 
biologics regulations. It is also based on reports by the U.S. House of 
Representatives Committee on Government Reform and Oversight 
Subcommittee on House Resources and Intergovernmental Relations, the 
General Accounting Office, and the Institute of Medicine, as well as on 
public comments. These actions are intended to help ensure the 
continued safety of the Nation's blood supply.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/00/05

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, HFM-
17, 1401 Rockville Pike, Suite 200N, Rockville, MD 20852-1448
Phone: 301 827-6210
Fax: 301 827-9434

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




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

Priority: Routine and Frequent

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

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

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM (Amendment)                06/00/05

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: None

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

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




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

Priority: Routine and Frequent

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

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

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM (Amendment)                06/00/05

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: None

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

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




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

Priority: Routine and Frequent

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

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

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM (Amendment) (Sinusitis 
Claim)                          08/02/04                    69 FR 46119
NPRM (Phenylephrine Bitartrate) 11/02/04                    69 FR 63482
NPRM (Phenyl propanolamine)     08/00/05
Final Action (Amendment) 
(Sinusitis Claim)               08/00/05

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Gerald M. Rachanow, Regulatory Counsel, Division of 
Over-the-Counter Drug Products, Department of Health and Human 
Services, Food and Drug Administration, HFD-560, Center for Drug 
Evaluation and Research, 5600

[[Page 26839]]

Fishers Lane, HFD-560, Rockville, MD 20857
Phone: 301 827-2241
Fax: 301 827-2315
Email: [email protected]

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




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

Priority: Routine and Frequent

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

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

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM (Amendment) (Labeling)     06/00/05
NPRM (Amendment) (Pediatric)    07/00/05
NPRM (Amendment) (Combinations 
with Sodium Bicarbonate)        01/00/06
NPRM (Amendment) 
(Overindulgence/ Hangover)      01/00/06

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: None

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

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




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

Priority: Routine and Frequent

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

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

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM (Convenience Sizes)        12/00/05

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: None

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

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




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

Priority: Routine and Frequent

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

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

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM (Amendment) (Emergency 
First Aid Eyewashes)            12/00/05

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: None

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

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

[[Page 26840]]

_______________________________________________________________________




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

Priority: Routine and Frequent

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

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

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM (Phenyl propanolamine)     08/00/05
NPRM (Benzocaine)               12/00/05

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: None

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

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




866. SUBSTANCES PROHIBITED FROM USE IN ANIMAL FOOD OR FEED

Priority: Other Significant. Major under 5 USC 801.

Legal Authority: 21 USC 321; 21 USC 342; 21 USC 343; 21 USC 349; 21 USC 
371

CFR Citation: 21 CFR 589.2001

Legal Deadline: None

Abstract: The Food and Drug Administration (FDA) is proposing to amend 
its regulations to prohibit the use of certain cattle origin materials 
in the food or feed of all animals to help strengthen existing 
safeguards to prevent the spread of bovine spongiform encephalopathy 
(BSE) in U.S. cattle. The discovery of a BSE-positive dairy cow in 
December 2003 has caused FDA to review its policies for prevention of 
BSE which resulted in this rulemaking.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

ANPRM                           07/14/04                    69 FR 42288
ANPRM Comment Period End        08/13/04
NPRM                            08/00/05

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Burt Pritchett, Biologist, Department of Health and 
Human Services, Food and Drug Administration, Center for Veterinary 
Medicine, HFV-222, 7519 Standish Place, MPN-4, Rockville, MD 20855
Phone: 240 453-6860
Fax: 240 453-6882
Email: [email protected]

RIN: 0910-AF46
_______________________________________________________________________




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

Priority: Routine and Frequent

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

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

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM (Amendment)                05/00/05

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: None

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

RIN: 0910-AF49
_______________________________________________________________________




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

Priority: Routine and Frequent

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

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

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            11/00/05

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: None

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

[[Page 26841]]

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

RIN: 0910-AF53
_______________________________________________________________________




869. [bull] OVER-THE-COUNTER (OTC) DRUG REVIEW--STIMULANT DRUG PRODUCTS

Priority: Routine and Frequent

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

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

Legal Deadline: None

Abstract: The OTC drug review establishes conditions under which OTC 
drugs are considered generally recognized as safe and effective and not 
misbranded. After a final monograph (i.e. final rule) is issued, only 
OTC drugs meeting the conditions of the monograph, or having an 
approved new drug application, may be legally marketed. This action 
addresses the use of stimulant active ingredients to relieve symptoms 
associated with a hangover.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM (Amendment) (Hangover)     01/00/06

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: None

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

RIN: 0910-AF56
_______________________________________________________________________




870. [bull] DESIGNATION OF NEW ANIMAL DRUGS FOR MINOR USE AND MINOR 
SPECIES

Priority: Other Significant

Legal Authority: 21 USC 360ccc-2

CFR Citation: 21 CFR 514.1(d)(1)(i)

Legal Deadline: NPRM, Statutory, August 2, 2005.
Final, Statutory, August 2, 2006.

Abstract: This proposed rule is being issued in response to the Minor 
Use and Minor Species (MUMS) Animal Health Act of 2004. The proposed 
rule implements section 573 of the MUMS Act which sets forth the 
functional requirements for drug sponsors requesting MUMS designation 
for proposed new animal drugs. MUMS designation of a new animal drug 
will allow drug sponsors to be granted seven years of exclusive 
marketing rights for these limited demand new animal drugs. This 
regulation will define content and format requirements for designation, 
requests changing designation ownership, and annual reporting 
requirements. This rule will also describe the criteria CVM will use 
for granting or denying these requests. Specific sections of the rule 
will be dedicated to documentation of MUMS status in a request, 
granting MUMS designation, and revocation of MUMS designation. This is 
a voluntary program for animal drug sponsors. While we do not have 
estimates of the impact on the animal drug industry, we expect that 
this rule will have a net beneficial impact on the industry with those 
firms participating who hope to profit as a result of the market 
exclusivity provided by the MUMS Act. A large number of these drug 
companies are classified as small businesses.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            08/00/05

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Andrew J. Beaulieu, Director, Office of Minor Use and 
Minor Species Animal Drug Development, Department of Health and Human 
Services, Food and Drug Administration, HFV-101, Center for Veterinary 
Medicine, 7519 Standish Place, Room 180, MPN-4, Rockville, MD 20855
Phone: 301 827-2974
Email: [email protected]

RIN: 0910-AF60
_______________________________________________________________________


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


Food and Drug Administration (FDA)



_______________________________________________________________________




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

Priority: Other Significant

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 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 prescription drugs (including biological products that are 
regulated as drugs), 21 CFR 201.56 and 201.57. The regulation would 
require that such labeling include highlights of prescribing 
information and a table of contents for prescribing information. It 
would reorder currently required information, make minor changes to its 
content, and establish minimum graphical requirements.

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                    05/00/05

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

[[Page 26842]]

Government Levels Affected: None

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 Research 
Administration, 5515 Security Lane, Suite 1101 (HFD-7), Rockville, MD 
20852
Phone: 301 594-2041
Fax: 301 827-5562

RIN: 0910-AA94
_______________________________________________________________________




872. 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 final 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              09/00/05

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: Undetermined

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-AA97
_______________________________________________________________________




873. 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.

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

CFR Citation: 21 CFR 312; 21 CFR 314

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

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

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

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-AB34
_______________________________________________________________________




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

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 
263a; 42 USC 264; 21 USC 372; 21 USC 372; 21 USC 381; 42 USC 263

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 of Medicine, 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                    12/00/05

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: None

[[Page 26843]]

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, HFM-
17, 1401 Rockville Pike, Suite 200N, Rockville, MD 20852-1448
Phone: 301 827-6210
Fax: 301 827-9434

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




875. 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 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 ingredients or 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                    09/00/05

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: 301 436-1209
Fax: 301 436-2964
Email: [email protected]

RIN: 0910-AB88
_______________________________________________________________________




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

Priority: Routine and Frequent

Legal Authority: 21 USC 331 to 334; 21 USC 341 to 344; 21 USC 348; 21 
USC 371; 21 USC 372; 21 USC 374; 21 USC 376; 21 USC 381; 21 USC 393; 42 
USC 264

CFR Citation: 21 CFR 59

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            04/29/04                    69 FR 23460
Final Action                    11/00/05

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: Undetermined

Agency Contact: Philip L. Chao, Senior Policy Analyst, Department of 
Health and Human Services, Food and Drug Administration, Office of 
Policy and Planning (HF-23), 5600 Fishers Lane, Room 14C-17, Rockville, 
MD 20857
Phone: 301 827-0587
Fax: 301 827-4774
Email: [email protected]

RIN: 0910-AB96
_______________________________________________________________________




877. 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: None

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                    09/00/05

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Carol Drew, Regulatory Counsel, Department of

[[Page 26844]]

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
_______________________________________________________________________




878. 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.
On September 22, 2004, FDA published a proposed rule that would require 
egg safety measures to prevent the contamination of shell eggs with SE 
during egg production. This proposal would reduce SE prevalence in the 
egg production environment and consequently in the eggs themselves. 
Most SE contamination of eggs is a result of SE infection in the laying 
hen's reproductive tract, called transovarian contamination. The 
proposed measures are designed to reduce the likelihood of this 
transovarian contamination and include: (1) provisions for procurement 
of chicks and pullets; (2) a biosecurity program; (3) a rodent and pest 
control program; (4) cleaning and disinfection of poultry houses that 
have had an environmental or egg test positive for SE; (5) egg testing 
when an environmental test is positive; and (6) refrigerated storage of 
eggs held at the farm.
Additionally, to verify that the measures have been effective, the rule 
proposes that producers test the poultry house environment for SE. If 
the environmental test is positive, eggs from that environment must be 
tested for SE, and if the egg test is positive, the eggs must be 
diverted to egg products processing or a treatment process that 
achieves at least a 5-log destruction of SE.
The proposed rule is one step in a broader farm-to-table egg safety 
effort that includes FDA's requirements for safe handling statements on 
egg cartons and refrigerated storage of shell eggs at retail and egg 
safety education for consumers and retail establishments. The rule had 
a 90-day comment period, which ended December 21, 2004. To discuss the 
proposed rule and solicit comments from interested stakeholders, FDA 
held three public meetings: October 28, 2004, in College Park, MD; 
November 9, 2004, in Chicago, IL; and November 16, 2004, in Los 
Angeles, CA.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/22/04                    69 FR 56824
Final Action                    04/00/06

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: Undetermined

Agency Contact: Louis J. Carson, Deputy Director, Food Safety 
Initiative, Department of Health and Human Services, Food and Drug 
Administration, Center for Food Safety and Applied Nutrition (HFS-032), 
5100 Paint Branch Parkway, College Park, MD 20740
Phone: 301 436-2130
Fax: 301 436-2632
Email: [email protected]

RIN: 0910-AC14
_______________________________________________________________________




879. INSTITUTIONAL REVIEW BOARDS: REGISTRATION REQUIREMENTS

Priority: Info./Admin./Other

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

CFR Citation: 21 CFR 56.106

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            07/06/04                    69 FR 40556
Final Action                    09/00/05

Regulatory Flexibility Analysis Required: Undetermined

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-AC17

[[Page 26845]]

_______________________________________________________________________




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

Priority: Other Significant

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

CFR Citation: 21 CFR 50.23

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              09/00/05

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

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

RIN: 0910-AC25
_______________________________________________________________________




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

Priority: Substantive, Nonsignificant

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

CFR Citation: 21 CFR 800.20

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            03/31/03                    68 FR 15404
NPRM Comment Period End         06/30/03
Final Action                    12/00/05

Regulatory Flexibility Analysis Required: No

Government Levels Affected: Undetermined

Federalism:  Undetermined

Agency Contact: Myrna Hanna, Regulations Staff, Department of Health 
and Human Services, Food and Drug Administration, Center for Devices 
and Radiological Health, HFZ-215, 1350 Piccard Drive, Rockville, MD 
20850
Phone: 301 827-2971
Fax: 301 594-4765
Email: [email protected]

RIN: 0910-AC32
_______________________________________________________________________




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

Priority: Economically Significant. Major under 5 USC 801.

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

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

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/10/02                    67 FR 76056
Final Action                    12/00/05

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Myrna Hanna, Regulations Staff, Department of Health 
and Human Services, Food and Drug Administration, Center for Devices 
and Radiological Health, HFZ-215, 1350 Piccard Drive, Rockville, MD 
20850
Phone: 301 827-2971
Fax: 301 594-4765
Email: [email protected]

RIN: 0910-AC34
_______________________________________________________________________




883. 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
NPRM Comment Period End         07/21/04
Final Action                    10/00/05

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

[[Page 26846]]

_______________________________________________________________________




884. REGISTRATION OF FOOD AND ANIMAL FEED FACILITIES

Priority: Other Significant

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; 21 CFR 20

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 final rule confirms the interim final rule that FDA 
issued on October 10, 2003 (68 FR 58894). The interim final rule 
implements 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). The Bioterrorism Act directs the Secretary to 
require facilities engaged in manufacturing, processing, packing, or 
holding of food for consumption in the United 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, 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 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, the food will be 
held at the port of entry or at a secure facility, until the foreign 
facility has registered.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            02/03/03                     68 FR 5377
Interim Final Rule              10/10/03                    68 FR 58894
Interim Final Rule Comment 
Period Reopened                 04/14/04                    69 FR 19766
Interim Final Rule Comment 
Period Reopened End             05/14/04
Final Rule                      06/00/05

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Catherine Copp, Special Assistant to the Associate 
Director, 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: 301 436-1589
Fax: 301 436-2637
Email: [email protected]

RIN: 0910-AC40
_______________________________________________________________________




885. 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 prior notice would provide the identity of 
the article of food; the manufacturer; the shipper; the grower, if 
known at the time of notification; the originating country; the 
shipping country; and the anticipated port of entry. The regulation 
identifies the parties responsible for providing the notice and 
explains the information that the prior notice is required to contain, 
the method of submission of the notice, and the minimum and maximum 
period of advance notice required. Section 307 also states that if FDA 
does not receive prior notice or receives inadequate prior notice, the 
imported food shall be refused admission and held at the port of entry 
until proper notice is provided.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            02/03/03                     68 FR 5428
Interim Final Rule              10/10/03                    68 FR 58974

[[Page 26847]]

Interim Final Rule Comment 
Period Reopened                 04/14/04                    69 FR 19763
Interim Final Rule Comment 
Period Reopened End             07/13/04
Final Rule                      06/00/05

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
_______________________________________________________________________




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

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

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

CFR Citation: 21 CFR 165.110(b)

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

Abstract: Under section 410 of the Federal Food, Drug, and Cosmetic Act 
(the Act), not later than 180 days before the effective date of a 
National Primary Drinking Water Regulation (NPDWR) issued by the 
Environmental Protection Agency (EPA) for a contaminant under section 
1412 of the Safe Drinking Water Act, the Food and Drug Administration 
(FDA) is required to issue a standard of quality regulation for that 
contaminant in bottled water or make a finding that such a regulation 
is not necessary to protect the public health because the contaminant 
is contained in water in public water systems but not in water used for 
bottled water. The effective date for any such standard of quality 
regulation is to be the same as the effective date of the NPDWR. On 
January 22, 2001, EPA published a final rule revising the existing 0.05 
mg/L maximum contaminant level (MCL) for arsenic in public drinking 
water to 0.01 mg/L (10 ppb). The effective date for this rule was 
temporarily delayed for 60 days from March 23, 2001, to a new effective 
date of May 22, 2001, in accordance with the memorandum of January 20, 
2001, from the Assistant to the President and Chief of Staff, entitled 
``Regulatory Review Plan'' (66 FR 7701; January 24, 2001). On May 22, 
2001, EPA announced that it would further delay the effective date for 
the rule until February 22, 2002, to allow time to complete a 
reassessment of the information on which the revised arsenic standard 
is based. On February 22, 2002, the arsenic MCL of 0.01 mg/L in public 
drinking water rule became effective and water systems must comply with 
the new standard for arsenic in public drinking water by January 23, 
2006. On March 25, 2003 (68 FR 14501 at 14503), EPA revised the rule 
text in its January 2001 final rule that established the 10 parts per 
billion arsenic drinking water standard to express the standard as 
0.010 mg/L, in order to clarify the implementation of the original 
rule. In accordance with section 410 of the Act, FDA is required to 
issue a standard of quality regulation for arsenic in bottled drinking 
water by July 27, 2005, with an effective date of January 23, 2006, or 
make a finding that such a regulation is not necessary to protect the 
public health.
FDA evaluated the MCL for arsenic established by EPA for drinking water 
and tentatively concluded that, as a standard of quality level for 
bottled water, it is adequate for the protection of public health. 
Certain waters used for bottled water may be expected to contain 
arsenic; thus, FDA believes that adopting EPA's MCL for arsenic will 
ensure that the quality of bottled water is equivalent to the quality 
of public drinking water that meets EPA standards. Therefore, on 
December 2, 2004, FDA proposed an allowable level for arsenic in 
bottled water of 0.010 mg/L (10 ppb).

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/02/04                    69 FR 70082
NPRM Comment Period End         01/31/05
Final Rule                      07/00/05

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: Undetermined

Federalism:  Undetermined

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

RIN: 0910-AF10
_______________________________________________________________________




887. 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.

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

CFR Citation: 21 CFR 312.120

Legal Deadline: None

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

[[Page 26848]]

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/10/04                    69 FR 32467
Final Action                    02/00/06

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

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
_______________________________________________________________________




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

Priority: Other Significant

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

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

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            07/30/03                    68 FR 44678
NPRM Comment Period End         10/28/03
Final Action                    12/00/05

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Brenda R. Friend, Regulatory Counsel, Department of 
Health and Human Services, Food and Drug Administration, Center for 
Biologics Evaluation and Research, 1401 Rockville Pike, Rockville, MD 
20852-1448
Phone: 301 827-6210
Fax: 301 827-9434

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




889. INFANT FORMULA: CURRENT GOOD MANUFACTURING PRACTICES; QUALITY 
CONTROL PROCEDURES; NOTIFICATION REQUIREMENTS; RECORDS AND REPORTS

Priority: Other Significant

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

CFR Citation: 21 CFR 106; 21 CFR 107

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Action                    12/00/05

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
_______________________________________________________________________




890. 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 on August 26, 2003.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Action                    12/00/05

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
_______________________________________________________________________




891. 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;

[[Page 26849]]

21USC 371a; 21 USC 331; 21 USC 360; 21 USC 371

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

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Action (Amendment) (Common 
Cold)                           12/00/05

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: None

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

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




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

Priority: Routine and Frequent

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

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

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Action (Technical 
Amendments)                     08/00/05
Final Action (Fever Blisters/
Cold Sores)                     01/00/06

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: None

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

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




893. 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; 21 USC 371a; 21 USC 331; 21 USC 358; 21 USC 360; 21 USC 360gg to 
360ss; 21 USC 371; 21 USC 374; 21 USC 379e; 42 USC 216; 42 USC 241; 42 
USC 262; 42 USC 264

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

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Action (Warnings)         11/00/05

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: None

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

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




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

Priority: Other Significant

Legal Authority: 21 USC 342; 21 USC 361; 21 USC 371

CFR Citation: 21 CFR 189.5; 21 CFR 700.27

Legal Deadline: None

Abstract: On July 14, 2004, FDA issued an interim final rule, effective 
immediately, to prohibit the use of certain cattle material, to address 
the potential risk of bovine spongiform encephalopathy (BSE), in human 
food, including dietary supplements, and cosmetics. Prohibited cattle 
materials include specified risk materials, small intestine of all 
cattle, material from nonambulatory disabled cattle, material from 
cattle not inspected and passed for human consumption, and mechanically 
separated (MS) (Beef). Specified risk materials are the brain, skull, 
eyes, trigeminal ganglia, spinal cord, vertebral column (excluding the 
vertebrae of the tail, the transverse processes of the thoracic and 
lumbar vertebrae, and the wings of the sacrum), and dorsal root ganglia 
of cattle 30 months and older; and the tonsils and distal ileum of the 
small intestine of all cattle. Prohibited cattle materials do not 
include tallow that contains no

[[Page 26850]]

more than 0.15 percent hexane-insoluble impurities and tallow 
derivatives. This action minimizes human exposure to materials that 
scientific studies have demonstrated are highly likely to contain the 
BSE agent in cattle infected with the disease. Scientists believe that 
the human disease variant Creutzfeldt-Jakob disease (vCJD) is likely 
caused by the consumption of products contaminated with the agent that 
causes BSE. After reviewing comments received to the interim final 
rule, FDA intends to issue a final rule.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              07/14/04                    69 FR 42256
Interim Final Rule Comment 
Period End                      10/12/04
Final Action                    01/00/06

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

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

RIN: 0910-AF47
_______________________________________________________________________




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

Priority: Other Significant

Legal Authority: 21 USC 342; 21 USC 361; 21 USC 371; 21 USC 381

CFR Citation: 21 CFR 189.5; 21 CFR 700.27

Legal Deadline: None

Abstract: On July 14, 2004, FDA proposed to require that manufacturers 
and processors of human food and cosmetics that are manufactured from, 
processed with, or otherwise contain, material from cattle must 
establish and maintain records sufficient to demonstrate the food or 
cosmetic is not manufactured from, processed with, or does not 
otherwise contain, prohibited cattle materials. This is a companion 
rulemaking to FDA's interim final rule entitled ``Use of Materials 
Derived From Cattle in Human Food and Cosmetics.`` FDA intends to 
finalize this proposal after reviewing any comments received.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            07/14/04                    69 FR 42275
NPRM Comment Period End         08/13/04
Final Action                    08/00/05

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: None

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

RIN: 0910-AF48
_______________________________________________________________________




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

Priority: Routine and Frequent

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

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

Legal Deadline: None

Abstract: The OTC drug review establishes conditions under which OTC 
drugs are considered generally recognized as safe and effective and not 
misbranded. After a final monograph (i.e. final rule) is issued, only 
OTC drugs meeting the conditions of the monograph, or having an 
approved new drug application, may be legally marketed. One action 
addresses the labeling of products containing sodium bicarbonate as an 
active ingredient. The other action addresses the use of antacids to 
relieve upset stomach associated with overindulgence in food and drink.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Action (Sodium Bicarbonate 
Labeling)                       01/00/06
Final Action (Overindulgence 
Labeling)                       01/00/06

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: None

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

RIN: 0910-AF52
_______________________________________________________________________




897. [bull] SUPPLEMENTS AND OTHER CHANGES TO APPROVED NEW ANIMAL DRUG 
APPLICATIONS

Priority: Substantive, Nonsignificant

Legal Authority: 21 USC 356a

CFR Citation: 21 CFR 25; 21 CFR 500; 21 CFR 514; 21 CFR 558

Legal Deadline: None

Abstract: The Food and Drug Administration (FDA) is amending its 
regulations on supplements and other changes to approved new animal 
drug applications (NADAs) or abbreviated new animal drug applications 
(ANADAs) to implement the manufacturing changes provision of the Food 
and Drug Modernization Act of 1997. The final rule requires 
manufacturers to assess the effect of a manufacturing change on the 
identity, strength, quality, purity, and potency of a drug as those 
factors relate to the safety or effectiveness of the drug. The final 
rule sets forth requirements for changes requiring submission and 
approval of a supplement before the distribution
of the drug made using the change, changes requiring the submission of 
a supplement at least 30 days prior to the distribution of the drug, 
changes requiring the submission of a supplement at the time of 
distribution

[[Page 26851]]

of the drug, and changes to be described in an annual report.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            10/01/99                    64 FR 53281
Final Action                    07/00/05
Final Action Effective          09/00/05

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Dennis Bensley Jr., Chemist, Department of Health and 
Human Services, Food and Drug Administration, 7500 Standish Place, MPN-
2, Room 320, HFV-140, Rockville, MD 20855
Phone: 301 827-6956
Email: [email protected]

RIN: 0910-AF59
_______________________________________________________________________




898. [bull] BIOLOGICAL PRODUCTS; BACTERIAL VACCINES AND TOXOIDS; 
IMPLEMENTATION OF EFFICACY REVIEW

Priority: Substantive, Nonsignificant

Legal Authority: 21 USC 321; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 
21 USC 358; 21 USC360; 21 USC 360b to 360d; 21 USC 360h; 21 USC 360i; 
21 USC 360gg to 360ss; 21 USC 371; 21 USC 372; 21 USC 374; 21 USC 379e; 
21 USC 381; 42 USC 216; 42 USC 241; 42 USC 262; 42 USC 263; 42 USC 
263a; 42 USC 264

CFR Citation: 21 CFR 201.59; 21 CFR 610.21

Legal Deadline: None

Abstract: On December 13, 1985, the Food and Drug Administration (FDA) 
proposed to amend the biologics regulations and proposed to classify 
the bacterial vaccines and toxoids on the basis of findings and 
recommendations of the Panel on Review of Bacterial Vaccines and 
Toxoids (the Panel). The Panel reviewed the safety, efficacy, and 
labeling of bacterial vaccines and toxoids with standards of potency, 
bacterial antitoxins, and immune globulins. After reviewing the Panel's 
report and comments on the proposal, FDA published a final rule and 
final order on January 5, 2004 (69 FR 255). On October 27, 2004, the 
United States District Court for the District of Columbia vacated the 
January 5, 2004, final rule and final order. On December 29, 2004 (69 
FR 78280), FDA published a withdrawal of the January 5, 2004, final 
rule and final order. Concurrently with the withdrawal of the final 
rule and final order, FDA published again a proposed rule and proposed 
order (69 FR 78281) to provide notice and to give interested persons an 
opportunity to comment. FDA is proposing to amend the biologics 
regulations in response to the report and recommendations of the Panel 
and in consideration of comments submitted to the Division of Dockets 
Management. FDA intends to classify these products as Category I (safe, 
effective, and not misbranded), Category II (unsafe, ineffective, or 
misbranded), or Category IIIB (off the market pending completion of 
studies permitting a determination of effectiveness).

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/29/04                    69 FR 78281
NPRM Comment Period End         03/29/05
Final Action                    07/00/05

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Astrid L. Szeto, Senior Regulatory Review Officer, 
Department of Health and Human Services, Food and Drug Administration, 
1401 Rockville Pike, Suite 200N, HFM-17, Rockville, MD 20852
Phone: 301 827-6210
Fax: 301-827-9434

RIN: 0910-AF62
_______________________________________________________________________


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


Food and Drug Administration (FDA)



_______________________________________________________________________




899. 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                     To Be                       Determined

[[Page 26852]]

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, Office of 
Policy and Planning (HF-23), 5600 Fishers Lane, Room 14C-17, Rockville, 
MD 20857
Phone: 301 827-0587
Fax: 301 827-4774
Email: [email protected]

RIN: 0910-AA61
_______________________________________________________________________




900. 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                            05/00/06

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: Undetermined

Federalism:  Undetermined

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

RIN: 0910-AC21
_______________________________________________________________________




901. REQUIREMENTS FOR SUBMISSION OF IN VIVO BIOEQUIVALENCE DATA

Priority: Substantive, Nonsignificant

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

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

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

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

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: None

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

RIN: 0910-AC23
_______________________________________________________________________




902. 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 notice 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

[[Page 26853]]

combination with saturated fat and cholesterol, as a footnote in the 
Nutrition Facts panel or as a disclosure statement in conjunction with 
claims to enhance consumers' understanding about such cholesterol-
raising lipids and how to use the information to make healthy food 
choices. Information and data obtained from comments and from consumer 
studies that will be conducted by FDA also may be used to help draft a 
proposed rule that would establish criteria for certain nutrient 
content or health claims or require the use of a footnote, or other 
labeling approach, about one or more cholesterol-raising lipids in the 
Nutrition Facts panel to assist consumers in maintaining healthy 
dietary practices.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

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

Regulatory Flexibility Analysis Required: No

Government Levels Affected: Federal

Agency Contact: Julie Moss, Consumer Safety Officer, Department of 
Health and Human Services, Food and Drug Administration, (HFS-832), 
HFS-830, 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
_______________________________________________________________________




903. 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

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
_______________________________________________________________________




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

Priority: Routine and Frequent

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

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

Legal Deadline: None

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

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: None

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

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




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

Priority: Routine and Frequent

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

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

Legal Deadline: None

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

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: None

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

[[Page 26854]]

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

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




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

Priority: Routine and Frequent

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

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

Legal Deadline: None

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

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: None

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

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




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

Priority: Routine and Frequent

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

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

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM (Amendment)                01/05/05                      70 FR 741
Final Action                     To Be                       Determined

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: None

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

RIN: 0910-AF51
_______________________________________________________________________




908. USE OF MATERIALS DERIVED FROM CATTLE IN MEDICAL PRODUCTS INTENDED 
FOR USE IN HUMANS AND DRUGS INTENDED FOR USE IN RUMINANTS

Priority: Other Significant

Legal Authority: 21 USC 501; 21 USC 502; 21 USC 505; 21 USC 512; 21 USC 
516; 21 USC 519; 21 USC 701; 21 USC 704; 21 USC 801; 42 USC 351; 42 USC 
361

CFR Citation: 21 CFR 116; 21 CFR 226.60; 21 CFR 300.200; 21 CFR 500; 21 
CFR 600.16; 21 CFR 895; 21 CFR 1271.465; 21 CFR 1271.470

Legal Deadline: None

Abstract: The regulation would prohibit the use of certain cattle 
material in the manufacture of medical products for humans and drugs 
for ruminants, and would require recordkeeping for products containing 
or manufactured with cattle materials to enable monitoring and 
enforcement of the prohibitions. The rule would prohibit the same 
cattle material that is prohibited in the previous FDA IFR that applies 
to foods and cosmetics. These include certain high risk tissues (e.g., 
brain, skull, eyes, spinal cord, trigeminal ganglia, parts of the 
vertebral column, and dorsal root ganglia) from cattle 30 months and 
older, tonsils and the distal ileum as well as the rest of the small 
intestine of cattle of any age, mechanically separated beef, material 
from nonambulatory disabled cattle, and material from cattle not 
inspected and passed for human consumption. The prohibitions would 
apply only to materials derived from animals slaughtered after the 
effective dates of the rules. The prohibitions would not apply to 
tallow that met a specified purity standard. The rule would provide 
criteria for deviations from the requirements based on a showing of 
safety or appropriate benefit to risk ratio.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                             To Be                       Determined

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Eric Flamm, Senior Policy Advisor, Office of Policy, 
Department of Health and Human Services, Food and Drug Administration, 
Office of the Commissioner, 5600 Fishers Lane, Room 15-61, HF-23, 
Rockville, MD 20857
Phone: 301 827-0891
Fax: 301 827-4774
Email: [email protected]

Related RIN: Merged with 0910-AF55
RIN: 0910-AF54

[[Page 26855]]

_______________________________________________________________________




909. [bull] LABEL REQUIREMENT FOR FOOD THAT HAS BEEN REFUSED ADMISSION 
INTO THE UNITED STATES

Priority: Other Significant

Legal Authority: 15 USC 1453 to 1455 ; 21 USC 321; 21 USC 343; 21 USC 
352; 21 USC 355; 21 USC 360b; 21 USC 362; 21 USC 371; 21 USC 374; 21 
USC 381; 42 USC 216; 42 USC 264

CFR Citation: 21 CFR 1.98

Legal Deadline: None

Abstract: The proposed rule would require owners or consignees to label 
imported food that is refused entry into the United States. The label 
would read, ``UNITED STATES: REFUSED ENTRY.'' The proposal would 
describe the label's characteristics (such as its size) and processes 
for verifying that the label has been affixed properly. We are taking 
this action to prevent the introduction of unsafe food into the United 
States, to facilitate the examination of imported food, and to 
implement section 308 of the Public Health Security and Bioterrorism 
Preparedness and Response Act of 2002 (the Bioterrorism Act) (Pub. L. 
107-188).

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                             To Be                       Determined

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: Undetermined

Agency Contact: Philip L. Chao, Senior Policy Analyst, Department of 
Health and Human Services, Food and Drug Administration, Room 15-61 
(HF-23), Office of Policy and Planning (HF-23), 5600 Fishers Lane, Room 
14C-17, Rockville, MD 20857
Phone: 301 827-0587
Fax: 301 827-4774
Email: [email protected]

RIN: 0910-AF61
_______________________________________________________________________


Department of Health and Human Services (HHS)         Completed Actions


Food and Drug Administration (FDA)



_______________________________________________________________________




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

Priority: Other Significant

CFR Citation: 21 CFR 16; 21 CFR 1270; 21 CFR 1271

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    11/24/04                    69 FR 68612

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-AB28
_______________________________________________________________________




911. ESTABLISHMENT AND MAINTENANCE OF RECORDS PURSUANT TO THE PUBLIC 
HEALTH SECURITY AND BIOTERRORISM PREPAREDNESS AND RESPONSE ACT OF 2002 
(COMPLETION OF A SECTION 610 REVIEW)

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 are 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                    12/09/04                    69 FR 71562

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, 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
_______________________________________________________________________




912. FOOD LABELING: FOOD ALLERGEN INGREDIENT LABELING

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

CFR Citation: 21 CFR 101

[[Page 26856]]

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn                       02/16/05

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: None

Federalism:  Undetermined

Agency Contact: Rhonda Rhoda Kane
Phone: 301 436-2371
Fax: 301 436-2636
Email: [email protected]

RIN: 0910-AF07
_______________________________________________________________________




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

Priority: Economically Significant. Major under 5 USC 801.

CFR Citation: 21 CFR 2.125

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    04/04/05                    70 FR 17168

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses, Governmental Jurisdictions

Government Levels Affected: Federal, State

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

RIN: 0910-AF18
_______________________________________________________________________




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

Priority: Other Significant

CFR Citation: 21 CFR 116; 21 CFR 226.60; 21 CFR 300.200; 21 CFR 500; 21 
CFR 600.16; 21 CFR 895; 21 CFR 1271.465; 21 CFR 1271.470

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn                       03/11/05

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Federalism:  Undetermined

Agency Contact: Eric Flamm
Phone: 301 827-0891
Fax: 301 827-4774
Email: [email protected]

Related RIN: Merged with 0910-AF54
RIN: 0910-AF55
_______________________________________________________________________


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


Health Resources and Services Administration (HRSA)



_______________________________________________________________________




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

Priority: Substantive, Nonsignificant

Legal Authority: 42 USC 11131

CFR Citation: 45 CFR 60.7

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

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

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

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

RIN: 0906-AA41
_______________________________________________________________________




916. 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                     06/00/05

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

[[Page 26857]]

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
_______________________________________________________________________




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

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

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

CFR Citation: 42 CFR 121

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/00/05

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

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

RIN: 0906-AA62
_______________________________________________________________________




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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/00/05

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

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

RIN: 0906-AA68
_______________________________________________________________________




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

Priority: Other Significant

Legal Authority: 42 USC 216

CFR Citation: 42 CFR 50.402

Legal Deadline: None

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

[[Page 26858]]

and Mental Health Services Administration and the Indian Health 
Service) which no longer require the use of an informal appeal 
procedure.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/00/05

Regulatory Flexibility Analysis Required: No

Government Levels Affected: Undetermined

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

RIN: 0906-AA69
_______________________________________________________________________




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

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

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

CFR Citation: 42 CFR 51(a)

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/00/05

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Jose Belardo, Director, Healthy Tomorrow's Partnership 
for Children Program, Department of Health and Human Services, Health 
Resources and Services Administration, 5600 Fishers Lane, Room 18A-55, 
Rockville, MD 20857
Phone: 301 443-0757
Email: [email protected]

RIN: 0906-AA70
_______________________________________________________________________


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


Health Resources and Services Administration (HRSA)



_______________________________________________________________________




921. 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                    06/00/05

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
_______________________________________________________________________




922. 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              12/16/03                    68 FR 70080
Final Action                    06/00/05

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

[[Page 26859]]

_______________________________________________________________________




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

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

Legal Authority: 42 USC 300ff-71

CFR Citation: Not Yet Determined

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            08/12/03                    68 FR 47923
NPRM Comment Period End         09/11/03
Final Action                    06/00/05

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

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

RIN: 0906-AA65
_______________________________________________________________________


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


Health Resources and Services Administration (HRSA)



_______________________________________________________________________




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

Priority: Substantive, Nonsignificant

Legal Authority: 42 USC 1396r-2

CFR Citation: 45 CFR 60

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                             To Be                       Determined

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: State

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

RIN: 0906-AA57
_______________________________________________________________________




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

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

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

CFR Citation: 42 CFR 121

Legal Deadline: None

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

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

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

RIN: 0906-AA63

[[Page 26860]]

_______________________________________________________________________


Department of Health and Human Services (HHS)         Completed Actions


Health Resources and Services Administration (HRSA)



_______________________________________________________________________




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

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

CFR Citation: 42 CFR 100

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn                       03/16/05

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Geoffrey Evans
Phone: 301 443-4198
Fax: 301 443 8196
Email: [email protected]

RIN: 0906-AA66
_______________________________________________________________________


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


Indian Health Service (IHS)



_______________________________________________________________________




927. [bull] SECTION 506--LIMITATION ON CHARGES FOR SERVICES FURNISHED BY 
MEDICARE PARTICIPATING INPATIENT HOSPITAL TO INDIANS

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

Legal Authority: MMA, sec 506; PL 108-173

CFR Citation: 42 CFR 135, subpart D; 42 CFR 489, subpart B

Legal Deadline: None

Abstract: This provision requires that as a condition of participation 
in the Medicare Program, providers accept payment at rates established 
by the Secretary in regulations as payment in full for services 
provided in an inpatient hospital to American Indians/Alaskan Natives 
(AI/AN) beneficiaries referred or authorized by the Indian Health 
Service, Tribes or Tribal organizations, or Urban Indian Organization 
(I/T/U).

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            08/00/05
NPRM Comment Period End         10/00/05
Final Action                    12/00/05

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Betty Z. Gould, Regulations Officer, Department of 
Health and Human Services, Indian Health Service, 12300 Twinbrook 
Parkway, Suite 450, Rockville, MD 20852
Phone: 301 443-1116
Email: [email protected]

RIN: 0917-AA07
_______________________________________________________________________


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


National Institutes of Health (NIH)



_______________________________________________________________________




928. 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                            09/00/05

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

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

RIN: 0925-AA10
_______________________________________________________________________




929. 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                            06/00/05

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

[[Page 26861]]

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
_______________________________________________________________________




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

Priority: Substantive, Nonsignificant

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

CFR Citation: 42 CFR 68g

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/00/05

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

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

RIN: 0925-AA33
_______________________________________________________________________




931. 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                            09/00/05

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

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

RIN: 0925-AA34
_______________________________________________________________________




932. 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                            09/00/05

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

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

RIN: 0925-AA35
_______________________________________________________________________




933. 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                            09/00/05

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

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

RIN: 0925-AA36

[[Page 26862]]

_______________________________________________________________________




934. 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                            09/00/05

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

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

RIN: 0925-AA41
_______________________________________________________________________


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


National Institutes of Health (NIH)



_______________________________________________________________________




935. 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                    09/00/05

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

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

RIN: 0925-AA18
_______________________________________________________________________




936. 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                            01/28/05                     70 FR 4080
Final Action                    06/00/05

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

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

RIN: 0925-AA28
_______________________________________________________________________




937. STANDARDS FOR A NATIONAL CHIMPANZEE SANCTUARY SYSTEM

Priority: Other Significant

Legal Authority: 42 USC 287a-3a

CFR Citation: 42 CFR 9

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

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            01/11/05                     70 FR 1843
Final Action                    09/00/05

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

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

RIN: 0925-AA31

[[Page 26863]]

_______________________________________________________________________


Department of Health and Human Services (HHS)             Prerule Stage


Office of Public Health and Science (OPHS)



_______________________________________________________________________




938. 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 National 
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                           08/00/05
ANPRM Comment Period End        11/00/05

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

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

RIN: 0940-AA11
_______________________________________________________________________


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


Office of Public Health and Science (OPHS)



_______________________________________________________________________




939. PUBLIC HEALTH SERVICE POLICIES ON RESEARCH MISCONDUCT

Priority: Other Significant

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

CFR Citation: 42 CFR 93

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

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

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

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

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




940. 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

[[Page 26864]]

information collection was submitted to the Office of Management and 
Budget under the Paperwork Reduction Act. Under the proposed rule, all 
registration information will be required, making the IRB registration 
system uniform with IRB registration requirements of the Food and Drug 
Administration (FDA), and creating a single, HHS IRB Registration 
system. FDA simultaneously published a proposed rule regarding FDA IRB 
registration requirements.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            07/04/04                    69 FR 40584
NPRM Comment Period End         10/04/04
Final Action                    12/00/05

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

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

RIN: 0940-AA06
_______________________________________________________________________




941. 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                    06/00/05

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

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

RIN: 0940-AA10
_______________________________________________________________________


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


Office of Public Health and Science (OPHS)



_______________________________________________________________________




942. 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                    08/00/06

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
_______________________________________________________________________




943. HUMAN SUBJECTS PROTECTION REGULATIONS: TRAINING AND ED. 
REQUIREMENTS FOR INSTITUTIONAL OFFICIALS, INSTITUTIONAL REVIEW BOARD 
MEMBERS AND STAFF, HUMAN PROTECTIONS ADMINISTRATORS, AND INVESTIGATORS

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

Legal Authority: 5 USC 301; 42 USC 289

CFR Citation: 45 CFR 46

Legal Deadline: None

Abstract: This notice of proposed rulemaking proposes to add subpart E 
to the Department of Health and Human Services (HHS) regulations for 
protection of human subjects, 45 CFR part 46, and would require that 
institutions engaged in human subjects research covered by an assurance 
of compliance filed with the Office for Human Research Protections 
ensure that institutional officials, institutional review board (IRB) 
chairpersons, and human protection administrators receive appropriate 
training and education about the institution's

[[Page 26865]]

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)



_______________________________________________________________________




944. 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 Conditions of 
Participation (CoPs) that Home Health Agencies (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                     01/00/06

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses, Organizations

Government Levels Affected: None

Agency Contact: Mercedes Benitez-McCray, Health Insurance Specialist, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, Clinical Standards Group, Division of Non-
Institutional Quality Standards, S3-05-14, 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, Clinical 
Standards Group, Division of Non-Institutional Quality Standards, S3-
05-15, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-9465

RIN: 0938-AG81
_______________________________________________________________________




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

Priority: Other Significant

Legal Authority: 42 USC 1302; 42 USC 1395hh

CFR Citation: 42 CFR 418

Legal Deadline: None

Abstract: This proposed rule is a regulatory reform initiative that 
would revise 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: Danielle Shearer, Health Insurance Specialist, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, Office of Clinical Standards Group, Division of Non-
Institutional Quality Standards, S3-02-01, 7500 Security Boulevard, 
Baltimore, MD 21244
Phone: 410 786-6617
Email: [email protected]

RIN: 0938-AH27
_______________________________________________________________________




946. STANDARD UNIQUE NATIONAL HEALTH PLAN IDENTIFIER (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                            11/00/05

Regulatory Flexibility Analysis Required: Yes

[[Page 26866]]

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 
Financial Management, Program Integrity Group, Divison of Provider/
Supplier Enrollment, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-7448

RIN: 0938-AH87
_______________________________________________________________________




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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

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

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
_______________________________________________________________________




948. 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                     12/00/05

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, Hospital and Ambulatory 
Policy Group Division of Ambulator, C4-15-18, 7500 Security Boulevard, 
Baltimore, MD 21244
Phone: 410 786-5919

RIN: 0938-AJ17
_______________________________________________________________________




949. 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                            09/00/05

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Ralph Goldberg, Health Insurance Specialist, Department 
of Health and Human Services, Centers for Medicare & Medicaid Services, 
C3-02-16, Center for Medicaid and State Operations, C3-02-16, 7500 
Security Boulevard, Baltimore, MD 21244
Phone: 410 786-4870

RIN: 0938-AJ98
_______________________________________________________________________




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

Priority: Economically Significant. Major under 5 USC 801.

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

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

CFR Citation: 45 CFR 162

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

[[Page 26867]]

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/00/05

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: Federal, Local, State, Tribal

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

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

RIN: 0938-AK62
_______________________________________________________________________




951. USE OF RESTRAINTS 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                            12/00/05

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected:  Businesses

Government Levels Affected: Undetermined

Federalism:  Undetermined

Agency Contact: Jan Tarantino, Health Insurance Specialist, Department 
of Health and Human Services, Centers for Medicare & Medicaid Services, 
Survey and Certification Group, Division of Contining Care Providers, 
S2-11-27, 7500 Security Boulevard, Baltimore, MD 21224
Phone: 410 786-0905

RIN: 0938-AL26
_______________________________________________________________________




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

Priority: Other Significant. Major under 5 USC 801.

Unfunded Mandates: Undetermined

Legal Authority: Not Yet Determined

CFR Citation: None

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            02/00/06

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
_______________________________________________________________________




953. 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                            02/00/06

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected:  Businesses, Governmental Jurisdictions, 
Organizations

Government Levels Affected: Federal, Local, State, Tribal

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

Agency Contact: Gladys C. Wheeler, Health Insurance Specialist, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, Office of HIPAA Standards, S2-24-18, 7500 Security 
Boulevard, Baltimore, MD 21244
Phone: 410 786-0273

RIN: 0938-AM50
_______________________________________________________________________




954. 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

[[Page 26868]]

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

CFR Citation: 42 CFR 483

Legal Deadline: None

Abstract: This proposed rule would establish requirements for hospice 
services that long term care (LTC) facilities must meet to participate 
in the Medicare and Medicaid programs. We are proposing this new 
requirement to ensure that quality hospice care is provided to eligible 
residents. This 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                            03/00/06

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, 
Quality Standards Group, Division of Institutional Quality Standards, 
S3-02-01, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-5646
Fax: 410-786-8532
Email: [email protected]

RIN: 0938-AM87
_______________________________________________________________________




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

Priority: Other Significant

Unfunded Mandates: Undetermined

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

CFR Citation: Not Yet Determined

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            05/00/05

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: State

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

RIN: 0938-AN09
_______________________________________________________________________




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

Priority: Other Significant. Major under 5 USC 801.

Unfunded Mandates: Undetermined

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

CFR Citation: Not Yet Determined

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

Abstract: Section 938 of the Medicare Prescription Drug, Improvement, 
and Modernization Act requires that physicians and beneficiaries be 
able to receive a prior determination regarding coverage of certain 
items and physicians' services (effective June 8, 2005).

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            08/00/05

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

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

RIN: 0938-AN10
_______________________________________________________________________




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

Priority: Economically Significant. Major under 5 USC 801.

Legal Authority: PL 108-173, MMA

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

Legal Deadline: Final, Statutory, January 1, 2007.

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                            09/00/05

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses, Governmental Jurisdictions, 
Organizations

Government Levels Affected: Federal, State

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

RIN: 0938-AN14

[[Page 26869]]

_______________________________________________________________________




958. 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 proposed rule would revise 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                            04/00/06

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses, Governmental Jurisdictions, 
Organizations

Government Levels Affected: Federal, Local, State, Tribal

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

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

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

RIN: 0938-AN25
_______________________________________________________________________




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

Priority: Substantive, Nonsignificant

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

CFR Citation: Not Yet Determined

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            10/00/05

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Anita Greenberg, Health Insurance Specialist, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, Center for Medicare Management, Hospital and 
Ambulatory Policy Group, Division of Acute Care, SL-11-17, 7500 
Security Boulevard, Baltimore, MD 21244
Phone: 410 786-4601
Email: [email protected]

RIN: 0938-AN26
_______________________________________________________________________




960. TERMINATION OF NON-RANDOM PREPAYMENT MEDICAL REVIEW (CMS-6022-P)

Priority: Other Significant. Major under 5 USC 801.

Legal Authority: Sec 934 of the MMA

CFR Citation: Not Yet Determined

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

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            07/00/05

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Federalism:  Undetermined

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

RIN: 0938-AN31
_______________________________________________________________________




961. LIMITATION ON RECOUPMENT OF OVERPAYMENTS (CMS-6025-P)

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

Legal Authority: Section 935 of the MMA

CFR Citation: None

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

Abstract: This proposed rule would implement one provision of section 
935 of the Medicare Modernization Act which added a new subsection to 
section 1893 of the Social Security Act. It would prohibit recoupment 
where a provider or supplier has appealed an overpayment determination 
until the reconsideration-level appeal is decided.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            01/00/06

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Nancy Braymer, Health Insurance Specialist, Department 
of Health and Human Services, Centers for Medicare & Medicaid Services, 
Division of Medicare Overpayments, C3-14-21, 7500 Security Boulevard, 
Baltimore, MD 21244
Phone: 410 786-4323
Email: [email protected]

RIN: 0938-AN42

[[Page 26870]]

_______________________________________________________________________




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

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

Unfunded Mandates: Undetermined

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

CFR Citation: Not Yet Determined

Legal Deadline: Final, Statutory, August 1, 2005.

Abstract: The proposed rule would update rates for the prospective 
payment system for inpatient rehabilitation facilities for FY 2006.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            05/00/05

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Federalism:  Undetermined

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

RIN: 0938-AN43
_______________________________________________________________________




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

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

Legal Authority: Sec 1895 of the Social Security Act

CFR Citation: Not Yet Determined

Legal Deadline: Final, Statutory, November 1, 2005.

Abstract: This poposed rule would set forth an update to the 60-day 
national episode rates and the national per-visit amounts under the 
Medicare prospective payment system for home health agencies.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/00/05

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Federalism:  Undetermined

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

RIN: 0938-AN44
_______________________________________________________________________




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

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

Legal Authority: BBA; BBRA; BIPA; MMA

CFR Citation: Not Yet Determined

Legal Deadline: Final, Statutory, November 1, 2005.

Abstract: The proposed rule would adjust payments under the Medicare 
hospital outpatient payment system beginning January 1, 2006.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            07/00/05

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: Federal

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

Agency Contact: Rebecca Kane, Health Insurance Specialist, Department 
of Health and Human Services, Centers for Medicare & Medicaid Services, 
C4-01-26, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-1589
Email: [email protected]

RIN: 0938-AN46
_______________________________________________________________________




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

Priority: Info./Admin./Other

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

CFR Citation: 42 CFR 402.400

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

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            08/00/05

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Joel Cohen, Health Insurance Specialist, Department of 
Health and Human Services, Centers for Medicare & Medicaid Services, 
Office of Financial Management, Program Integrity Group, 7500 Security 
Boulevard, Baltimore, MD 21244
Phone: 410 786-3349
Email: [email protected]

RIN: 0938-AN48
_______________________________________________________________________




966. CHANGES TO THE HOSPITAL INPATIENT PROSPECTIVE PAYMENT SYSTEM AND FY 
2006 RATES (CMS-1500-P)

Priority: Economically Significant. Major under 5 USC 801.

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

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

Legal Deadline: NPRM, Statutory, April 1, 2005.
Final, Statutory, August 1, 2005.

Abstract: This rule proposes to revise the Medicare hospital inpatient 
prospective payment system (IPPS) for

[[Page 26871]]

operating and capital-related costs to implement changes arising from 
our continuing experience with these systems. In addition, in the 
Addendum to this proposed rule, we describe the proposed changes to the 
amounts and factors used to determine the rates for Medicare hospital 
inpatient services for operating costs and capital-related costs. These 
proposed changes would be applicable to discharges occurring on or 
after October 1, 2005. We also are setting forth proposed rate-of-
increase limits as well as proposed policy changes for hospitals and 
hospital units excluded from the IPPS that are paid in full or in part 
on a reasonable cost basis subject to these limits.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            05/00/05

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: Federal

Agency Contact: Marc Hartstein, Acting Deputy Division Director, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, Division of Acute Care, Hospital and Ambulatory 
Policy Group, Center for Medicare Management, C4-25-11, 7500 Security 
Boulevard, Baltimore, MD 21224
Phone: 410 786-6192

RIN: 0938-AN57
_______________________________________________________________________




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

Priority: Economically Significant. Major under 5 USC 801.

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

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

Legal Deadline: None

Abstract: This proposed rule would cover prosthetics and certain 
custom-fabricated orthotics only if furnished by a ``qualified 
practitioner'' and fabricated by a ``qualified practitioner'' or 
``qualified supplier. In consultation with experts this rule would set 
forth a process to establish and periodically update a list of custom-
fabricated orthotics and prosthetics subject to this rule.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            11/00/05

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: Undetermined

Federalism:  Undetermined

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

Ralph Goldberg, Health Insurance Specialist, Department of Health and 
Human Services, Centers for Medicare & Medicaid Services, N3-21-28, 
7500 Security Boulevard, Baltimore, MD 21224
Phone: 410 786-8864

RIN: 0938-AN63
_______________________________________________________________________




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

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

Unfunded Mandates: Undetermined

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

CFR Citation: Not Yet Determined

Legal Deadline: Final, Statutory, July 30, 2005.

Abstract: This rule proposes updates to payment rates used under the 
Skilled Nursing Facility Prospective Payment System (SNF PPS) beginning 
October 1, 2005.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            05/00/05

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Federalism:  Undetermined

Agency Contact: William Ullman, Health Insurance Specialist, Department 
of Health and Human Services, Centers for Medicare & Medicaid Services, 
C4-13-15, Center for Medicare Management, Chronic Care Policy Group, 
Division of Institutional Post Acute Care, C5-07-08, 7500 Security 
Boulevard, Baltimore, MD 21244
Phone: 401 786-5667

RIN: 0938-AN65
_______________________________________________________________________




969. [bull] PHYSICIANS' REFERRALS TO HEALTH CARE ENTITIES WITH WHICH 
THEY HAVE FINANCIAL RELATIONSHIPS; COMMUNITYWIDE HEALTH INFORMATION 
SYSTEMS AND ELECTRONIC PRESCRIBLING EXCEPTION (CMS-1303-P)

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

Unfunded Mandates: Undetermined

Legal Authority: 1827(b)(4)-(b)(5); 1860D-4(e)(6); 1860D-42(e)(8)(B)

CFR Citation: 42 CFR 411.357

Legal Deadline: Final, Statutory, January 1, 2006.

Abstract: This rule proposes an exception to the physician self-
referral prohibition for certain nonmonetary remuneration related to 
electronic prescribing (section 1860D-4 of the Medicare Modernization 
Act). (This rule and subsequent final rule must be published by 
November 1, 2005, to be effective January 1, 2006.)

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            05/00/05

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Linda Howard, Health Insurance Specialist, Department 
of Health and Human Services, Centers for Medicare & Medicaid Services, 
C5-13-08, 7500 Security Boulevard, Baltimore, MD 21244-1850
Phone: 410 786-5255
Email: [email protected]

RIN: 0938-AN69

[[Page 26872]]

_______________________________________________________________________




970. [bull] NATIONAL PLAN AND PROVIDER ENUMERATION SYSTEM (NPPES) DATA 
DISSEMINATION (CMS-6060-N)

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

Legal Authority: HIPAA of 1996, secs 1171 to 1179 of the Social 
Security Act (42 USC 1329d to 1320d-8); NPI final rule (01/23/2004); 
NPS System of Records (07/28/1998)

CFR Citation: 45 CFR 163

Legal Deadline: None

Abstract: The National Provider Identifier final rule, published 
January 23, 2004, stated that CMS would publish a follow-up notice to 
describe the data dissemination processes and any applicable charges 
for data. This notice describes the data that would be available from 
the National Plan and Provider Enumeration System (NPPES), in 
compliance with the provisions of the Privacy Act, the Freedom of 
Information Act, the Electronic Freedom of Information Act (FOIA) 
Amendments of 1996, and other applicable regulations and authorities, 
and must be consistent with the National Provider System of Records 
Notice, published on July 28, 1998. The notice would describe the data 
dissemination strategy, processes, and any applicable charges for data.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Notice                          10/00/05

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Helen Dietrick, Health Insurance Specialist, Department 
of Health and Human Services, Centers for Medicare & Medicaid Services, 
Office of Financial Management, Program Integrity Group, Division of 
Provider/Supplier Enrollment, 7500 Security Boulevard, C3-02-16, 
Baltimore, MD 21244
Phone: 410 786-7448
Email: [email protected]

RIN: 0938-AN71
_______________________________________________________________________




971. [bull] MEDICARE INTEGRITY PROGRAM, FISCAL INTERMEDIARY AND CARRIER 
FUNCTIONS, AND CONFLICT OF INTEREST REQUIREMENTS (CMS-6030-P2)

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

Unfunded Mandates: Undetermined

Legal Authority: Sec 902 of the MMA

CFR Citation: Not Yet Determined

Legal Deadline: None

Abstract: On March 20, 1998, we issued a proposed rule to implement 
provisions of section 1893 of the Act to which we received comments 
(HCFA-7020-P, 63 FR 13590). Due to time constraints, a final rule was 
never published within the three-year time frame required by section 
902 of the MMA. Without a proposed MIP regulation in effect, we lack 
the authority to contract with entities to perform section 1893 program 
integrity activities upon the implementation of the part D 
Pharmaceutical benefit. Accordingly, we must issue a proposed rule 
prior to the effective date of the part D Pharmaceutical benefit 
regulations.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            05/00/05

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected:  Businesses

Government Levels Affected: None

Agency Contact: Lauren Haley, Health Insurance Specialist, Department 
of Health and Human Services, Centers for Medicare & Medicaid Services
Phone: 410 786-1730

Related RIN: Related to 0938-AI09
RIN: 0938-AN72
_______________________________________________________________________




972. [bull] CHANGES TO THE DISCLOSURE OF INFORMATION REQUIREMENTS FOR 
QUALITY IMPROVEMENT ORGANIZATIONS (CMS-3156-P)

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

Legal Authority: Not Yet Determined

CFR Citation: Not Yet Determined

Legal Deadline: None

Abstract: This proposed rule would add a provision to the existing 
Quality Improvement Organization (QIO) confidentiality regulations 
allowing the release of Medicare beneficiary-specific information, with 
patient consent, from the QIO to practitioners and providers in a 
treatment relationship with the beneficiary. This release may only be 
permitted after the beneficiary has consented to the release and has 
been provided notice of the release. The new provisions will also 
permit the release of Medicare beneficiary-specific information, with 
patient consent, from the QIO to other QIOs, subcontractors to QIOs, 
and CMS for educational and quality improvement purposes. Additionally, 
the rule would add provisions for the Medicare beneficiary complaint 
system that is required by the statute and administered by the QIOs.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            03/00/06

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, Division of Quality Improvement, S3-02-01, 7500 
Security Boulevard, Baltimore, MD 21244-1850
Phone: 410 786-1775
Email: [email protected]

RIN: 0938-AN73
_______________________________________________________________________




973. [bull] HOME HEALTH PAYMENT SYSTEM RATE UPDATE FOR CALENDAR YEAR 
2007 (CMS-1304-P)

Priority: Economically Significant. Major under 5 USC 801.

Legal Authority: Social Security Act, sec 1895

CFR Citation: 42 CFR 484

Legal Deadline: Final, Statutory, July 31, 2006, To allow five months 
for systems change before the January 1, 2007, effective date.

Abstract: The 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, effective 
on January 1, 2007. In addition, this rule proposes the first major 
refinements to the

[[Page 26873]]

payment system since its implementation in October of 2000.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/00/05

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Federalism:  Undetermined

Agency Contact: Randy Throndset, Health Insurance Specialist, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, C5-07-28, 7500 Security Boulevard, Baltimore, MD 
21244
Phone: 410 786-0131
Email: [email protected]

RIN: 0938-AN76
_______________________________________________________________________




974. [bull] INPATIENT PSYCHIATRIC FACILITY PROSPECTIVE PAYMENT SYSTEM--
UPDATE FOR 2006 (CMS-1306-P)

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

Unfunded Mandates: Undetermined

Legal Authority: PL 106-113, sec 124 BBRA

CFR Citation: 42 CFR 412.400, subpart N

Legal Deadline: Final, Statutory, May 1, 2006.

Abstract: This rule would update the Inpatient Psychiatric Facility 
Prospective Payment System for 2006. This rule would update and revise 
the market basket and the use of new market area definitions.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/00/05

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected:  Businesses, Governmental Jurisdictions

Government Levels Affected: Local

Federalism:  Undetermined

Agency Contact: Paul Olenick, Director, Division of Technical Payment 
Policy, Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, C5-05-27, 7500 Security Boulevard, Baltimore, MD 
21244
Phone: 410 786-4533
Email: [email protected]

RIN: 0938-AN82
_______________________________________________________________________




975. [bull] REVISIONS TO PAYMENT POLICIES UNDER THE PHYSICIAN FEE 
SCHEDULE FOR CALENDAR YEAR 2006 (CMS-1502-P)

Priority: Economically Significant. Major under 5 USC 801.

Unfunded Mandates: Undetermined

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

CFR Citation: 42 CFR 410; 42 CFR 414

Legal Deadline: Final, Statutory, November 1, 2005.

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            07/00/05

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Federalism:  Undetermined

Agency Contact: Diane Milstead, 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: 410 786-3355

Related RIN: Related to 0938-AN04
RIN: 0938-AN84
_______________________________________________________________________


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


Centers for Medicare & Medicaid Services (CMS)



_______________________________________________________________________




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

Priority: Other Significant

Legal Authority: 42 USC 1302; 42 USC 1395hh

CFR Citation: 42 CFR 424

Legal Deadline: None

Abstract: This final rule is needed as part of the Administration's 
anti-fraud and abuse efforts. It would give HHS the authority to enroll 
and reenroll providers with time frames for reenrollment.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

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

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Michael Collett, Health Insurance Specialist, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, Office of Financial Management, Program Integrity 
Group, Division of Provider/Supplier Enrollment, N3-22-17, 7500 
Security Boulevard, Baltimore, MD 21244
Phone: 410 786-6121

RIN: 0938-AH73
_______________________________________________________________________




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

Priority: Substantive, Nonsignificant

Legal Authority: 42 USC 1302; 42 USC 1395hh

CFR Citation: 42 CFR 482

Legal Deadline: None

Abstract: This interim final rule with comment period requires 
hospitals that transfuse blood and blood products to prepare and follow 
written procedures for appropriate action when it is determined that 
blood and blood

[[Page 26874]]

products the hospital received and transfused are at increased risk for 
transmitting hepatitis C virus (HCV); quarantine prior collections from 
a donor who is at increased risk for transmitting HCV infection; notify 
transfusion recipients, as appropriate, of the need for HCV testing and 
counseling; and maintain records for at least 10 years.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            11/16/00                    65 FR 69416
Interim Final Rule With Comment 10/00/05

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Mary Collins, Health Insurance Specialist, Department 
of Health and Human Services, Centers for Medicare & Medicaid Services, 
Clincial Standards Group, Division of Institutional Quality Standards, 
S3-05-16, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-3189

RIN: 0938-AJ29
_______________________________________________________________________




978. 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: Linda Smith, Health Insurance Specialist, Department of 
Health and Human Services, Centers for Medicare & Medicaid Services, 
Chronic Care Policy Group, Division of Community Post Acute Care, C5-
02-24, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-5650

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




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

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

Legal Authority: Sec 1102 of the Social Security Act; Sec 1871 of the 
Social Security Act; 42 USC 1302 ; 42 USC 1359 hh

CFR Citation: 42 CFR 410.38

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              05/00/05

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Karen Daily, Health Insurance Specialist, Department of 
Health and Human Services, Centers for Medicare & Medicaid Services, 
7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-0189
Email: [email protected]

RIN: 0938-AM74
_______________________________________________________________________




980. 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: Sarah Shipey, Health Insurance Specialist, Department 
of Health and Human Services, Centers for Medicare & Medicaid Services, 
C4-11-05, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-0187

RIN: 0938-AN19
_______________________________________________________________________




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

Priority: Other Significant

Legal Authority: Not Yet Determined

CFR Citation: None

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

Abstract: This final rule updates the list of Medicare-covered ASC 
procedures.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            11/26/04                    69 FR 69178
Interim Final Rule              05/00/05

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: None

Agency Contact: Dana Burley, Health Insurance Specialist, Department of 
Health and Human Services, Centers for Medicare & Medicaid Services, 
Center for Medicare Management, C4-05-17, 7500 Security Boulevard, 
Baltimore, MD 21244

[[Page 26875]]

Phone: 410 786-4547
Email: [email protected]

RIN: 0938-AN23
_______________________________________________________________________




982. MEDICARE SECONDARY PAYER AMENDMENTS (CMS-6272-IFC)

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

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

CFR Citation: 42 CFR 411

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

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule With Comment 08/00/05

Regulatory Flexibility Analysis Required: No

Government Levels Affected: Undetermined

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

RIN: 0938-AN27
_______________________________________________________________________




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

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: Final, Statutory, May 1, 2005.

Abstract: This final 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.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            02/03/05                     70 FR 5723
Final Action                    05/00/05

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: None

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

RIN: 0938-AN28
_______________________________________________________________________




984. DEVELOPMENT OF NEW STANDARDS FOR MEDIGAP POLICIES (CMS-4087-FN)

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

Legal Authority: Section 104 of the MMA

CFR Citation: None

Legal Deadline: None

Abstract: According to section 104 of the Medicare Prescription Drug, 
Improvement, and Modernization Act of 2003 (MMA), Medigap issuers must 
send written notice to beneficiaries with Medigap drug coverage during 
the 60-day period immediately preceding the initial Medicare Part D 
enrollment period which begins November 15, 2005. Therefore, Medigap 
issuers will have to send the notices from mid-September 2005 to mid-
November 2005. This final notice will set forth the standards for the 
written notice that Medigap issuers must provide to policyholders with 
drug coverage.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Notice                    08/00/07

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Julie Walton, Health Insurance Specialist, Department 
of Health and Human Services, Centers for Medicare & Medicaid Services, 
Center for Beneficiary Choices, Medicare Plan Policy Group, Division of 
Private Health Insurance, S3-16-16, 7500 Security Boulevard, Baltimore, 
MD 21224
Phone: 410 786-4622
Email: [email protected]

Related RIN: Related to 0938-AN08
RIN: 0938-AN50
_______________________________________________________________________




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

Priority: Economically Significant. Major under 5 USC 801.

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

CFR Citation: 42 CFR 457

Legal Deadline: Final, Statutory, September 30, 2005.

Abstract: This notice sets forth the final allotments of Federal 
funding available to each State, the District of Columbia, and each 
U.S. Territory and Commonwealth for fiscal year 2006.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Notice                          08/00/05

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: State

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

RIN: 0938-AN56
_______________________________________________________________________




986. [bull] ALL PROVIDER BAD DEBT PAYMENT (CMS-1126-F)

Priority: Other Significant

Legal Authority: SSA, sec 1834

CFR Citation: 42 CFR 412; 42 CFR 413; 42 CFR 1902

Legal Deadline: None

Abstract: This final rule will achieve a consistent bad debt 
reimbursement policy for all providers currently

[[Page 26876]]

eligible to receive payments from Medicare for bad debt. It implements 
a court settlement agreement and removes the cap on End Stage Renal 
Disease (ESRD) bad debt reimbursement, which limits payment of 
allowable bad debts to the facility's unrecovered costs

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Action                    02/00/06

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: None

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

Related RIN: Related to 0938-AK02
RIN: 0938-AN75
_______________________________________________________________________




987. [bull] STATE CHILDREN'S HEALTH INSURANCE PROGRAM (SCHIP); 
REDISTRIBUTION OF UNEXPENDED SCHIP FUNDS FROM THE APPROPRIATION FOR 
FISCAL YEAR (FY) 2002 (CMS-2230-FN)

Priority: Other Significant

Legal Authority: 42 USC 1397dd; 42 USC 1397ee; Social Security Act, sec 
2104(e); Social Security Act, sec 2104(f)

CFR Citation: 42 CFR 457.600 to 457.630

Legal Deadline: None

Abstract: This notice responds to comments from the notice with comment 
published January 19, 2005, announcing the procedure for redistribution 
of States' unexpended FY 2002 allotments that remained at the end of FY 
2004 to those States that fully expended the FY 2002 SCHIP allotment. 
These redistributed allotments will be available through the end of FY 
2005 (September 30, 2005).

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Notice                          05/00/05

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: State

Federalism:  Undetermined

Agency Contact: Richard Strauss, Department of Health and Human 
Services, Centers for Medicare & Medicaid Services, Offfice of 
Financial Management, S3-13-15, 7500 Security Boulevard, Baltimore, MD 
21244
Phone: 410 786-2019
Email: [email protected]

RIN: 0938-AN78
_______________________________________________________________________




988. [bull] EXTENDING SUNSET DATE FOR THE INTERIM FINAL REGULATION ON 
MENTAL HEALTH PARITY (CMS-4094-F3)

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

Legal Authority: Mental Health Parity Act

CFR Citation: 42 CFR 146

Legal Deadline: None

Abstract: On October 4, 2004, legislation was enacted that extended the 
Public Health Service (PHS) Act provisions of the Mental Health Parity 
Act (MHPA) to services furnished through December 31, 2005. As a result 
of the most recently enacted legislation, it is now necessary to again 
publish conforming changes to the interim final regulation published 
June 27, 2003. These changes conform the regulatory sunset date to the 
new statutory sunset date (December 31, 2005), and extend the duration 
of the increased cost exemption to be consistent with the new sunset 
date. The conforming changes make absolutely no substantive changes to 
the existing regulation. (It is important to publish this amendment 
expeditiously, because it will have no meaning if published after 
December 31, 2005 (or, if published immediately before that date)).

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Action                    07/00/05

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

Related RIN: Related to 0938-AN22
RIN: 0938-AN80
_______________________________________________________________________




989. [bull] APPLICATION OF INHERENT REASONABLENESS TO ALL MEDICARE PART 
B SERVICES (OTHER THAN PHYSICIAN SERVICES) (CMS-1908-F)

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

Legal Authority: BBA; BBRA

CFR Citation: 42 CFR 405

Legal Deadline: None

Abstract: This rule finalizes the December 13, 2002, interim final rule 
and sets forth the process for establishing realistic and equitable 
payment amounts for all Medicare part B items and services (other than 
physician services) when the existing payment amounts are inherently 
unreasonable because they are either grossly excessive or grossly 
deficient. The rule describes the factors CMS (or its carriers) will 
consider, and the procedures that will be followed in establishing 
realistic and equitable payment amounts. This rule implements section 
4316 of the BBA, and section 223 of the BBRA that required CMS to 
publish this subsequent final rule.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              12/13/02                    67 FR 76684
Interim Final Rule Comment 
Period End                      02/11/03
Final Rule                      12/00/06

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Bill Long, Health Insurance Specialist, Department of 
Health and Human Services, Centers for Medicare & Medicaid Services, 
Center for Medicare Management, C5-08-27, 7500 Security Boulevard, 
Baltimore, MD 21244
Phone: 410 786-5655
Email: [email protected]

RIN: 0938-AN81

[[Page 26877]]

_______________________________________________________________________




990. [bull] ELECTRONIC SUBMISSION OF COST REPORTS: REVISION TO COST 
REPORTING PERIOD (CMS-1199-IFC)

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

Legal Authority: Not Yet Determined

CFR Citation: Not Yet Determined

Legal Deadline: None

Abstract: This interim final rule follows a August 26, 2003, final rule 
that requires ESRD facilities, hospices, rural health clinics, 
federally qualified health centers, and community mental health centers 
to file cost reports in a standardized electronic format. It provided a 
delay or waiver of this requirement if implementation would result in 
financial hardship. Because the software packages for accepting the 
cost reports are not available yet, this final rule changes the cost 
report ending date from December 31, 2004, to March 31, 2005.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule Comment 
Period End                      05/00/05

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Darryl E. Simms, Health Insurance Specialist, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, C5-03-30, 7500 Security Boulevard, Baltimore, MD 
21244
Phone: 410 786-4524
Email: [email protected]

Related RIN: Related to 0938-AL51
RIN: 0938-AN87
_______________________________________________________________________


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


Centers for Medicare & Medicaid Services (CMS)



_______________________________________________________________________




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

Priority: Other Significant

Legal Authority: 42 USC 1395rr et al

CFR Citation: 42 CFR 400; 42 CFR 405; 42 CFR 410; 42 CFR 412 to 414; 42 
CFR 488; 42 CRR 494

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            02/04/05                     70 FR 6184
Final Action                    02/00/08

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: None

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

Robert Miller, Health Insurance Specialist, Department of Health and 
Human Services, Centers for Medicare & Medicaid Services, S3-02-01, 
Clinical Standards Group, Division of Non-Institutional Quality 
Standards, S3-04-25, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-6797

RIN: 0938-AG82
_______________________________________________________________________




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

Priority: Other Significant

Legal Authority: 42 USC 1302; 42 USC 1395hh

CFR Citation: 42 USC 405; 42 USC 482; 42 USC 488

Legal Deadline: None

Abstract: This rule establishes conditions of participation for 
Medicare-covered transplant centers.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            02/04/05                     70 FR 6140
Final Action                    02/00/08

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

RIN: 0938-AH17
_______________________________________________________________________




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

Priority: Other Significant. Major under 5 USC 801.

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

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

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

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              01/25/99                     64 FR 3748
Final Action                    12/00/06

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected:  Businesses

Government Levels Affected: State, Local, Tribal

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

[[Page 26878]]

Agency Contact: Rebecca Donnay, Health Insurance Specialist, Department 
of Health and Human Services, Centers for Medicare & Medicaid Services, 
Clinical Standards Group, Division of Non-Institutional Quality 
Standards, SL-17-04, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-1428

RIN: 0938-AJ10
_______________________________________________________________________




994. 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; 42 CFR 442; 42 CFR 483

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

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

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Larry Cutler, Health Insurance Specialist, Department 
of Health and Human Services, Centers for Medicare & Medicaid Services, 
S2-14-26, Disabled & Elderly Health Programs Group, Division of 
Benefits & Coverage Policy, S2-12-11, 7500 Security Boulevard, 
Baltimore, MD 21244
Phone: 410 786-5903

RIN: 0938-AJ96
_______________________________________________________________________




995. PHYSICIANS' REFERRALS TO HEALTH CARE ENTITIES WITH WHICH THEY HAVE 
FINANCIAL RELATIONSHIPS (CMS-1810-F)

Priority: Other Significant

Legal Authority: 42 USC 1877

CFR Citation: 42 CFR 411; 42 CFR 424

Legal Deadline: None

Abstract: This final rule incorporates into regulation certain 
statutory provisions that preclude payment for services under Medicare 
if a physician makes a referral to a facility in which he or 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
Correction Notice               04/06/04                    69 FR 17933
 Second Correction Notice       09/24/04                    69 FR 57226
Final Action                    06/00/07

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses, Organizations

Government Levels Affected: None

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

RIN: 0938-AK67
_______________________________________________________________________




996. ORGAN PROCUREMENT ORGANIZATION CONDITIONS FOR COVERAGE (CMS-3064-F)

Priority: Economically Significant. Major under 5 USC 801.

Legal Authority: 42 USC 1302 et al

CFR Citation: 42 CFR 413; 42 CFR 441; 42 CFR 486; 42 CFR 498

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

Abstract: This rule establishes 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                            02/04/05                     70 FR 6086
Final Action                    02/00/08

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Diane Corning, Health Insurance Specialist, Department 
of Health and Human Services, Centers for Medicare & Medicaid Services, 
Clinical Standards Group, Division of Institutional Quality Standards, 
S3-05-06, 7500 Security Boulevard, Baltimore, MD 21224
Phone: 410 786-8486
Email: [email protected]

RIN: 0938-AK81
_______________________________________________________________________




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

Priority: Substantive, Nonsignificant

Legal Authority: Sec 1878 of the Social Security Act

CFR Citation: 42 CFR 405

Legal Deadline: None

Abstract: This final rule redefines, clarifies, and updates the 
guidelines and procedures for Provider Reimbursement Review Board 
appeals, based on recent court decisions.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/25/04                    69 FR 35716

[[Page 26879]]

NPRM Comment Period End         08/24/04
Final Action                    06/00/07

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: None

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

RIN: 0938-AL54
_______________________________________________________________________




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

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 final rule will clarify certain portability requirements 
for group health plans and issuers of health insurance coverage offered 
in connection with a group health plan. It also implements 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                            12/30/04                    69 FR 78800
Final                           12/00/07

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses, Organizations

Government Levels Affected: Federal, Local, State

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

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

RIN: 0938-AL88
_______________________________________________________________________




999. 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                    12/00/06

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: None

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

RIN: 0938-AM22
_______________________________________________________________________




1000. REQUIREMENTS FOR LONG-TERM CARE FACILITIES; NURSING SERVICES; 
POSTING OF NURSE STAFFING INFORMATION (CMS-3121-F)

Priority: Other Significant

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

CFR Citation: 42 CFR 483

Legal Deadline: None

Abstract: This final rule implements section 941 of the Medicare, 
Medicaid, and SCHIP Benefits Improvement and Protection Act of 2000 and 
requires nursing homes to post daily, for each shift, the number of 
full-time equivalents (FTEs) of registered nurses, 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, Health Insurance Specialist, Department 
of Health and Human Services, Centers for Medicare & Medicaid Services, 
S3-04-26, Clinical Standards Goup, Division of Institutional Quality 
Standards, S3-04-26, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-5646
Fax: 410 786-8532
Email: [email protected]

RIN: 0938-AM55
_______________________________________________________________________




1001. REVISIONS TO THE APPEALS PROCESS FOR INITIAL CLAIM DETERMINATIONS 
(CMS-4064-IFC)

Priority: Economically Significant. Major under 5 USC 801.

Legal Authority: Sec 521 of BIPA

CFR Citation: 42 CFR 40S

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              03/08/05                    70 FR 11419
Final Action                    03/00/08

Regulatory Flexibility Analysis Required: No

[[Page 26880]]

Government Levels Affected: Federal

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

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




1002. HOSPITAL CONDITIONS OF PARTICIPATION: REQUIREMENTS FOR HISTORY AND 
PHYSICAL EXAMINATIONS; AUTHENTICATION OF VERBAL ORDERS; SECURING 
MEDICATIONS; AND POST-ANESTHESIA EVALUATIONS (CMS-3122-P2)

Priority: Other Significant

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

CFR Citation: 42 CFR 482

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            03/25/05                    70 FR 15266
Final Action                    03/00/08

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Organizations

Government Levels Affected: None

Additional Information: Decreases burden for hospitals and clinicaians.

Agency Contact: Patricia Chmielewski, Health Insurance Specialist, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, Office of Clinical Standards and Quality, Clinical 
Standards Group, Division of Institutional Quality Standards, S3-04-05, 
7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-6899
Email: [email protected]

RIN: 0938-AM88
_______________________________________________________________________




1003. REVISED CIVIL MONEY PENALTIES, ASSESSMENTS, EXCLUSIONS, AND 
RELATED APPEALS PROCEDURES (CMS-6146-F)

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

Unfunded Mandates: Undetermined

Legal Authority: Not Yet Determined

CFR Citation: Not Yet Determined

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

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

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

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

RIN: 0938-AM98
_______________________________________________________________________




1004. PAYMENT FOR RESPIRATORY ASSIST DEVICES WITH BI-LEVEL CAPABILITY 
AND A BACK-UP RATE (CMS-1167-F)

Priority: Other Significant

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

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

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

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            08/22/03                    68 FR 50735
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, Chronic Care Policy Group, Division of 
Community Post Acute Care, C5-07-26, 7500 Security Boulevard, 
Baltimore, MD 21244
Phone: 410 786-4499
Email: [email protected]

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




1005. EVALUATION CRITERIA AND STANDARDS FOR QUALITY IMPROVEMENT PROGRAM 
CONTRACTS (CMS-3142-FN)

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

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

CFR Citation: None

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

Abstract: Section 1153(h)(2) of the Act Social Security requires the 
Secretary to publish in the Federal Register the general criteria and 
standards that will be used to evaluate the Quality Improvement 
Organizations (QIOs), and provide opportunity for public comment. This 
notice will describe the evaluation criteria CMS will use to evaluate 
the QIOs. There should be no additional costs associated with this 
requirement. The evaluation portion of

[[Page 26881]]

the contract has already been factored into the award.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

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

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

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

RIN: 0938-AN13
_______________________________________________________________________




1006. MEDICARE AMBULANCE FEE SCHEDULE UPDATE (CMS-1492-F)

Priority: Other Significant

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

CFR Citation: 42 CFR 414, subpart H

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

Abstract: This interim final rule codifies the four payment provisions 
for Medicare covered ambulance servies contained in section 414 of the 
Medicare Prescription Drug, Improvement and Modernization Act of 2003 
(MMA).

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

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

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: Local

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

RIN: 0938-AN24
_______________________________________________________________________




1007. NONDISCRIMINATION IN HEALTH COVERAGE AND WELLNESS PLANS IN THE 
GROUP MARKET (CMS-4081-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 final rule governs 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 1996. It also addresses comments we received on 
the Bonafide Wellness Plan proposed rule (CMS-2078-P).

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

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

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses, Governmental Jurisdictions

Government Levels Affected: Local, State

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

RIN: 0938-AN29
_______________________________________________________________________




1008. 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 at afforded by that CoP. It 
finalizes six standards that ensure minimum protections of each 
patient's physical and emotional health and safety. These standards 
address each patient's right to: notification of his or her rights; the 
exercise of his or her rights in regard to his or her care; privacy and 
safety; confidentiality of patient records; freedom from restraints 
used in the provision of acute medical and surgical care unless 
clinically necessary; and freedom from seclusion and restraint for 
behavior management unless clinically necessary.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

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

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Janice Graham, Health Insurance Specialist, Department 
of Health and Human Services, Centers for Medicare & Medicaid Services, 
Office of Clinical Standards and Quality, Division of Institutional 
Quality Standards, S3-05-27, 7500 Security Boulevard, Baltimore, MD 
21244
Phone: 410 786-8020
Email: [email protected]

RIN: 0938-AN30

[[Page 26882]]

_______________________________________________________________________




1009. FEDERAL ENFORCEMENT IN GROUP AND INDIVIDUAL HEALTH INSURANCE 
MARKETS (CMS-4091-F)

Priority: Other Significant

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

CFR Citation: 45 CFR 150.101 to 150.465

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

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

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: Local, State

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

RIN: 0938-AN35
_______________________________________________________________________




1010. FIRE SAFETY REQUIREMENTS FOR CERTAIN HEALTH CARE FACILITIES; 
ALCOHOL-BASED HAND SANITIZER AMENDMENT (CMS-3145-IFC)

Priority: Other Significant

Legal Authority: Not Yet Determined

CFR Citation: 42 CFR 403; 42 CFR 416; 42 CFR 418; 42 CFR 460; 42 CFR 
482; 42 CFR 483; 42 CFR 485

Legal Deadline: None

Abstract: This interim final rule with comments 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 adopts 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 will increase a provider's flexibility in meeting infection 
control goals while minimizing potential fire safety concerns. 
Additionally, this rule would include a requirement for placement of 
battery operated smoke detectors in resident rooms in non-sprinkled 
SNFs.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule With Comments03/25/05                    70 FR 15229
Final Action                    03/00/08

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Additional Information: Providers requesting publication of this 
regulation.

Agency Contact: Danielle Shearer, Health Insurance Specialist, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, Office of Clinical Standards Group, Division of Non-
Institutional Quality Standards, S3-02-01, 7500 Security Boulevard, 
Baltimore, MD 21244
Phone: 410 786-6617
Email: [email protected]

RIN: 0938-AN36
_______________________________________________________________________




1011. MEDICARE MODERNIZATION ACT; ELECTRONIC PRESCRIBING (CMS-0011-F)

Priority: Economically Significant. Major under 5 USC 801.

Legal Authority: 42 USC 1395

CFR Citation: Not Yet Determined

Legal Deadline: Final, Statutory, September 1, 2005, Required e-
prescribing before outset of January 1, 2006, Medicare part D drug 
benefit.

Abstract: This rule requires Medicare part D plans and Medicare 
Advantage Plans to enable transmission of basic prescription data to 
and from doctors and pharmacies, and to adopt a number of the initial 
standards required for electronic prescribing by section 1860(d) of the 
Medicare Modernization Act.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            02/04/05                     70 FR 6255
Final Action                    02/00/08

Regulatory Flexibility Analysis Required: No

Government Levels Affected: Federal, Local, State, Tribal

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

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

RIN: 0938-AN49
_______________________________________________________________________




1012. MEDICARE PART B COMPETITIVE ACQUISITION OF OUTPATIENT DRUGS AND 
BIOLOGICALS (CMS-1325-F)

Priority: Economically Significant. Major under 5 USC 801.

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

CFR Citation: 42 CFR 414

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

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

[[Page 26883]]

vendors selected in a competitive bidding process. If the physician 
elects to obtain drugs from a competitive vendor, the vendor will bill 
Medicare for the drug.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            03/04/05                    70 FR 10745
Final Action                    03/00/08

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Edmund E. Kasaitis, Health Insurance Specialist, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, Center for Medicare Management, C4-01-26, 7500 
Security Boulevard, Baltimore, MD 21244
Phone: 410 786-0477
Email: [email protected]

RIN: 0938-AN58
_______________________________________________________________________




1013. GROUP MARKET HEALTH INSURANCE REFORM: GUARANTEED AVAILABILITY, 
GUARANTEED RENEWABILITY, DISCLOSURES TO SMALL EMPLOYERS (CMS-4102-F)

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

Legal Authority: 42 USC 300gg-92

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

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Action                    12/00/06

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: David R. Mlawsky, Health Insurance Specialist, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, Center for Beneficiary Choices, Mediare Plan Policy 
Group, Division of Private Health Insurance, S3-16-26, 7500 Security 
Boulevard, Baltimore, MD 21244
Phone: 877 267-2323
Email: [email protected]

Related RIN: Related to 0938-AI08
RIN: 0938-AN60
_______________________________________________________________________




1014. INDIVIDUAL MARKET HEALTH INSURANCE REFORM: PORTABILITY FROM GROUP 
TO INDIVIDUAL COVERAGE; FEDERAL RULES FOR ACCESS IN THE INDIVIDUAL 
MARKET; STATE ALTERNATIVE MECHANISMS TO FEDERAL RULES (CMS-4103-F)

Priority: Other Significant. Major under 5 USC 801.

Legal Authority: 42 USC 300gg-92

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

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Action                    12/00/06

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

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

Related RIN: Related to 0938-AI08
RIN: 0938-AN61
_______________________________________________________________________




1015. REVISIONS TO THE OVERSIGHT AND VALIDATION PROGRAM FOR ACCREDITING 
ORGANIZATIONS APPROVED FOR DEEMING AUTHORITY (CMS-2255-P)

Priority: Other Significant. Major under 5 USC 801.

Legal Authority: Social Security Act, sec 1864; Social Security Act, 
sec 1865; Social Security Act, sec 1875

CFR Citation: 42 CFR 488.1 to 488.9

Legal Deadline: None

Abstract: This proposed rule would respond to the recommendations in 
the GAO Report, ``CMS Needs Additional Authority to Adequately Oversee 
Patient Safety in Hospitals'' (GAO-04-850). With respect to the 
oversight and validation of hospital accreditation programs, a rate of 
disparity calculation is specified in Federal regulations at 42 CFR, 
488.8. This rule proposes to consider additional alternative measures 
to assess the performance of the accreditation organizations.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/00/06

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: Undetermined

Agency Contact: Amber L. Wolfe, Health Insurance Specialist, Department 
of Health and Human Services, Centers for Medicare & Medicaid Services, 
Center for Medicaid and State Operations, Survey and Certification 
Group, Division of Acute Care Services, S2-12-25, 7500 Security 
Boulevard, Baltimore, MD 21244
Phone: 410 786-6773
Email: [email protected]

RIN: 0938-AN62
_______________________________________________________________________




1016. [bull] PAYMENT ERROR RATE MEASUREMENT (PERM) PROGRAM (CMS-6026-F)

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

Legal Authority: Improper Payment Information Act of 2002

CFR Citation: 42 CFR 431; 42 CFR 457

Legal Deadline: Final, Statutory, October 1, 2005.

Abstract: This rule requires States to estimate improper payments in 
the

[[Page 26884]]

Medicaid program and the State Children's Health Insurance Program. The 
State level estimates will be used to produce estimates of improper 
payments for both Medicaid and SCHIP at the national level. These 
national level estimates will enable us to comply with the Improper 
Payments Information Act of 2002. The intended effect of this 
regulation is for States to produce estimates of improper payments for 
their Medicaid and SCHIP programs and identify existing and emerging 
vulnerabilities that can be effectively targeted for corrective actions 
by the States.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Action                    08/00/07

Regulatory Flexibility Analysis Required: No

Government Levels Affected: State

Agency Contact: Chrstine Jones, Health Insurance Specialist, Department 
of Health and Human Services, Centers for Medicare & Medicaid Services, 
C3-02-16, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-3722
Email: [email protected]

Related RIN: Related to 0938-AM86
RIN: 0938-AN77
_______________________________________________________________________




1017. [bull] FIRE SAFETY REQUIREMENTS FOR LONG-TERM CARE FACILITIES: 
SPRINKLER SYSTEMS (CMS-3191-P)

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

Unfunded Mandates: Undetermined

Legal Authority: 42 USC 1302; 42 USC 1395hh

CFR Citation: 42 CFR 483

Legal Deadline: None

Abstract: On July 16, 2004, GAO published a report on Federal fire 
safety standards and procedures in nursing facilities. The GAO Report 
recommended that CMS explore requiring sprinkler systems in all nursing 
facilities. This proposed rule would implement this regulation. We 
propose to require sprinkler systems in all long-term care facilities 
and solicit public comment regarding an appropriate and feasible phase-
in period for this regulation.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/00/06

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected:  Businesses

Government Levels Affected: None

Agency Contact: Danielle N. Shearer, Health Insurance Specialist, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, S3-02-01, 7500 Security Boulevard, Baltimore, MD 
21244
Phone: 410 786-6617
Fax: 410 786-8532
Email: [email protected]

RIN: 0938-AN79
_______________________________________________________________________




1018. [bull] PROGRAM FOR ALL-INCLUSIVE CARE FOR THE ELDERLY (PACE): 
PROGRAM REVISIONS (CMS-1201-F)

Priority: Other Significant

Legal Authority: PL 108-173, sec 902 of MMA; BIPA, sec 903

CFR Citation: 42 CFR 460

Legal Deadline: None

Abstract: This rule finalizes two interim final rules with comment 
periods. The November 24, 1999, rule established requirements for 
Programs of All-inclusive Care for the Elderly (PACE) under the 
Medicare and Medicaid programs and the October 1, 2002, rule that 
implemented section 903 of BIPA. These are pre-paid, capitated programs 
for beneficiaries who meet special eligibility requirements and who 
elect to enroll.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Action                    12/00/06

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses, Governmental Jurisdictions, 
Organizations

Government Levels Affected: Federal, Local, State, Tribal

Federalism:  Undetermined

Agency Contact: Paul Olenick, Director, Division of Beneficiary and 
Insurance Issues, Department of Health and Human Services, Centers for 
Medicare & Medicaid Services, C4-07-07, 7500 Security Boulevard, 
Baltimore, MD 21244-1850
Phone: 410 786-4472

Related RIN: Previously reported as 0938-AL59
RIN: 0938-AN83
_______________________________________________________________________


Department of Health and Human Services (HHS)         Completed Actions


Centers for Medicare & Medicaid Services (CMS)



_______________________________________________________________________




1019. HEALTH COVERAGE PORTABILITY FOR GROUP HEALTH PLANS AND GROUP 
HEALTH INSURANCE ISSUERS (CMS-2151-F)

Priority: Economically Significant. Major under 5 USC 801.

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; . . .

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    12/30/04                    69 FR 78720

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: Federal, Local, State

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

Agency Contact: David Mlawsky
Phone: 410 786-6851

RIN: 0938-AL43

[[Page 26885]]

_______________________________________________________________________




1020. PROSPECTIVE PAYMENT SYSTEM FOR INPATIENT PSYCHIATRIC FACILITIES 
FOR FY 2004 (CMS-1213-F)

Priority: Economically Significant. Major under 5 USC 801.

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

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    11/15/04                    69 FR 66922

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: Federal, Local, State

Agency Contact: Lana Price
Phone: 410 786-4533
Email: [email protected]

RIN: 0938-AL50
_______________________________________________________________________




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

Priority: Other Significant

CFR Citation: None

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Notice                          12/30/04                    69 FR 78825

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: David Mlawsky
Phone: 410 786-6851

RIN: 0938-AL64
_______________________________________________________________________




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

Priority: Other Significant

CFR Citation: 42 CFR 405

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    11/26/04                    69 FR 69251

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: Federal

Agency Contact: Janet Miller
Phone: 410 786-1588

RIN: 0938-AL67
_______________________________________________________________________




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

Priority: Substantive, Nonsignificant

CFR Citation: 42 CFR 421.210

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    02/25/05                     70 FR 9232
Notice                          02/25/05                     70 FR 9358

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Colette Shatto
Phone: 410 786-6932

RIN: 0938-AL76
_______________________________________________________________________




1024. PROCEDURES FOR MAINTAINING CODE LISTS IN THE NEGOTIATED NATIONAL 
COVERAGE DETERMINATIONS FOR CLINICAL DIAGNOSTIC LABORATORY SERVICES 
(CMS-3119-FN)

Priority: Other Significant

CFR Citation: None

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    02/25/05                     70 FR 9355

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Jacqueline Sheridan-Moore
Phone: 410 786-4635

RIN: 0938-AM36
_______________________________________________________________________




1025. CHANGES TO THE HOSPITAL OUTPATIENT PROSPECTIVE SYSTEM AND CALENDAR 
YEAR 2005 PAYMENT RATES (CMS-1427-FC)

Priority: Economically Significant. Major under 5 USC 801.

CFR Citation: Not Yet Determined

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    11/15/04                    69 FR 65682

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: Federal

Agency Contact: Joan Sanow
Phone: 410 786-9739
Email: [email protected]

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




1026. REVISIONS TO PAYMENT POLICIES UNDER THE PHYSICIAN FEE SCHEDULE FOR 
CALENDAR YEAR 2005 (CMS-1429-FC)

Priority: Economically Significant. Major under 5 USC 801.

CFR Citation: 42 CFR 410; 42 CFR 414

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    11/15/04                    69 FR 66235

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: Federal

Agency Contact: Diane Milstead
Phone: 410 786-3355

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




1027. PHYSICIAN REFERRAL FOR NUCLEAR MEDICINE SERVICES AND SUPPLIES 
(CMS-1261-P)

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

CFR Citation: 42 CFR 411.351

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Merged With 0938-AN84           05/03/05

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Joanne Sinsheimer
Phone: 410 786-4620
Email: [email protected]

RIN: 0938-AN04
_______________________________________________________________________




1028. MEDICARE ADVANTAGE PROGRAM--TITLE II (CMS-4069-F)

Priority: Other Significant

CFR Citation: 42 CFR 417; 42 CFR 422

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    01/28/05                     70 FR 4588

Regulatory Flexibility Analysis Required: No

[[Page 26886]]

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Jane Andrews
Phone: 410 786-3133
Email: [email protected]

RIN: 0938-AN06
_______________________________________________________________________




1029. MEDICARE DRUG BENEFIT EFFECTIVE CALENDAR YEAR 2006--TITLE I (CMS-
4068-F)

Priority: Other Significant

CFR Citation: 42 CFR 417; 42 CFR 423

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    01/28/05                     70 FR 4193

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses, Governmental Jurisdictions

Government Levels Affected: Federal, State, Tribal

Agency Contact: Tracey McCutcheon
Phone: 410 786-6715
Email: [email protected]

Related RIN: Related to 0938-AN07
RIN: 0938-AN08
_______________________________________________________________________




1030. SCHEDULE FOR PUBLISHING MEDICARE FINAL REGULATIONS AFTER A 
PROPOSED OR INTERIM FINAL REGULATION (CMS-9026-N)

Priority: Other Significant

CFR Citation: None

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Notice                          12/30/04                    69 FR 78442

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Renee Swann
Phone: 410 786-4492
Email: [email protected]

RIN: 0938-AN12
_______________________________________________________________________




1031. MODIFICATIONS TO MANAGED CARE RULES (CMS-4041-IFC)

Priority: Other Significant

CFR Citation: 42 CFR 422

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              12/30/04                    69 FR 78336

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Tony Hausner
Phone: 410 786-1093

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




1032. FURNISHING HOSPITALS WITH INFORMATION TO COMPUTE THE 
DISPROPORTIONATE SHARE HOSPITAL FORMULA (CMS-1283-P)

Priority: Economically Significant

CFR Citation: 42 CFR 412

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Merged With 0938-AN57           02/16/05

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Sherry Amstead
Phone: 410 786-4342
Email: [email protected]

RIN: 0938-AN52
_______________________________________________________________________




1033. END STAGE RENAL DISEASE (ESRD) COMPOSITE RATE EXCEPTION (CMS-1278-
P)

Priority: Substantive, Nonsignificant

CFR Citation: 42 CFR 405

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Merged With 0938-AN84           03/04/05

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Michael E Powell
Phone: 410 786-4557
Email: [email protected]

RIN: 0938-AN53
_______________________________________________________________________




1034. TIME LIMITATION ON RECORDKEEPING REQUIREMENTS UNDER THE DRUG 
REBATE PROGRAM (CMS-2175-F)

Priority: Other Significant. Major under 5 USC 801.

CFR Citation: 42 CFR 447.534

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    11/26/04                    69 FR 68815

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: State

Agency Contact: Kimberly M. Howell
Phone: 410 786-6762
Email: [email protected]

Larry Reed
Phone: 410 786-3325
Email: [email protected]

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




1035. [bull] RECOGNITION OF NAIC STANDARDS FOR REGULATION OF MEDICARE 
SUPPLEMENTAL INSURANCE (CMS-4080-N)

Priority: Other Significant

Legal Authority: MMA, sec 104

CFR Citation: None

Legal Deadline: None

Abstract: The notice recognizes the revised NAIC Model standards (per 
Medicare Modernization Act section 104) for regulation of Medicare 
supplemental insurance. State departments of insurance need CMS' 
official recognition of the NAIC Model standards as soon as possible 
after the NAIC adopts the revised Model at their September 2004 
meeting. (The States need sufficient lead time to prepare their 
legislative proposals, which generally take place in the Spring. States 
must implement the revised NAIC Model standards by September 2005.)

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Notice                          03/25/05                    70 FR 15394

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Julie Walton, Health Insurance Specialist, Department 
of Health and Human Services, Centers for Medicare & Medicaid Services, 
S3-16-16, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-4622
Email: [email protected]

RIN: 0938-AN66

[[Page 26887]]

_______________________________________________________________________




1036. [bull] QUALITY IMPROVEMENT ORGANIZATIONS CONTRACTS: SOLICITATION 
OF STATEMENTS OF INTEREST FROM IN-STATE ORGANIZATIONS--ALASKA, HAWAII, 
IDAHO, MAINE, SOUTH CAROLINA, VERMONT, AND WYOMING (CMS-3155-N)

Priority: Other Significant

Legal Authority: Social Security Act, sec 1153(i); Social Security Act, 
sec 1152; Social Security Act, sec 1153; Omnibus Budget Reconcilation 
Action of 1987, PL 100-203

CFR Citation: 42 CFR 475.102; 42 CFR 475.103

Legal Deadline: None

Abstract: Under Section 1153(i) of the Social Security Act, this notice 
provides at least six months advanced notice of the expiration dates of 
contracts with out-of-State Utilization and Quality Control Peer Review 
Organizations.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Notice                          02/04/05                     70 FR 6012

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Udo Nwachukwu, Office of Clinical Standards and 
Quality, Department of Health and Human Services, Centers for Medicare 
& Medicaid Services, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-7234

RIN: 0938-AN67
_______________________________________________________________________




1037. [bull] PROCEDURES FOR THE SUBMISSION OF NON-PRIVACY ADMINISTRATIVE 
SIMPLIFICATION COMPLAINTS UNDER THE HEALTH INSURANCE PORTABILITY AND 
ACCOUNTABILITY ACT OF 1996 (CMS-0014-N)

Priority: Other Significant

Legal Authority: 42 USC 1302a; 42 USC 1320d to 1320d-8

CFR Citation: None

Legal Deadline: None

Abstract: This notice sets forth the procedures for filing with the 
Secretary of the Department of Health and Human Services, a complaint 
of noncompliance by a covered entity with certain provisions of the 
administrative simplification rules under 45 CFR parts 160, 162, and 
164. It also describes the procedures the Department employs to review 
the complaints. These procedures are intended to facilitate the 
investigation and resolution of these complaints.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Notice                          03/25/05                    70 FR 15329

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Lori E. Davis, Deputy Director, Office of HIPPAA 
Standards, Department of Health and Human Services, Centers for 
Medicare & Medicaid Services, S2-26-17, 7500 Security Boulevard, 
Baltimore, MD 21244
Phone: 410 786-4160
Email: [email protected]

RIN: 0938-AN68
_______________________________________________________________________




1038. [bull] CLINICAL LABORATORY IMPROVEMENT AMENDMENTS OF 1988; 
CONTINUANCE OF EXEMPTION OF LABORATORIES LICENSED BY THE STATE OF 
WASHINGTON (CMS-2207-N)

Priority: Other Significant

Legal Authority: None

CFR Citation: 42 CFR 493

Legal Deadline: None

Abstract: This notice announces that clinical laboratories located in 
the State of Washington that possess a valid license under the Medical 
Test Site Licensure Law continue to be exempt from the requirements of 
the Clinical Laboratory Improvement Amendments of 1988 (CLIA) until 
March 31, 2007. (This notice should be published by March 31, 2005, as 
the date for continued approval of this authority has passed. Delay in 
publishing this notice could cause confusion for labs licensed by the 
State of Washington as to which requirements Federal or State they must 
conform.)

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Notice                          04/29/05                    70 FR 22317

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: State

Agency Contact: Sandra Farragut, Department of Health and Human 
Services, Centers for Medicare & Medicaid Services, S2-12-25, 7500 
Security Boulevard, Baltimore, MD 21244
Phone: 410 786-3503
Email: [email protected]

RIN: 0938-AN70
_______________________________________________________________________


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


Administration for Children and Families (ACF)



_______________________________________________________________________




1039. SAFEGUARDING CHILD SUPPORT AND EXPANDED FEDERAL PARENT LOCATOR 
SERVICES (FPLS) INFORMATION

Priority: Substantive, Nonsignificant

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

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

Legal Deadline: None

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

[[Page 26888]]

of collecting child support, and the safeguarding of information. This 
regulation would update various sections in 45 CFR chapter III to 
reflect the statutory changes.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/00/05

Regulatory Flexibility Analysis Required: No

Government Levels Affected: Local, State, Tribal

Agency Contact: Elizabeth C. Matheson, Director, Policy and Planning 
Division, Department of Health and Human Services, Administration for 
Children and Families, Office of Child Support Enforcement, 370 
L'Enfant Promenade SW., Washington, DC 20447
Phone: 202 401-9386
Email: [email protected]

RIN: 0970-AC01
_______________________________________________________________________




1040. DEVELOPMENTAL DISABILITIES AND BILL OF RIGHTS ACT

Priority: Substantive, Nonsignificant

Legal Authority: PL 106-402; 42 USC 15001 et seq

CFR Citation: 45 CFR 1385 to 1388

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

Abstract: A notice of proposed rulemaking 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                            09/00/05

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Governmental Jurisdictions, Organizations

Government Levels Affected: Local, State, Tribal

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

RIN: 0970-AC07
_______________________________________________________________________




1041. ADMINISTRATIVE COST SHARING UNDER TANF

Priority: Substantive, Nonsignificant

Legal Authority: 42 USC 1302

CFR Citation: 45 CFR 263; 45 CFR 263.14

Legal Deadline: None

Abstract: This proposed rule will enable States (including the District 
of Columbia) and territories to use either the ``primary program'' cost 
allocation methodology previously allowed under the Aid to Families 
with Dependent Children (AFDC) program to allocate the common 
administrative costs of determining eligibility in the Temporary 
Assistance for Needy Families (TANF) program, the Medicaid program, and 
the Food Stamp programs, or to continue to use a ``benefiting'' cost 
allocation methodology. Pursuant to a determination by Secretary 
Leavitt, 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                            09/00/05

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: Local, State

Agency Contact: Grant Collins, Deputy Director, Department of Health 
and Human Services, Administration for Children and Families, 5th Floor 
East, 370 L'Enfant Promenade SW., Washington, DC 20447
Phone: 202 401-6953
Email: [email protected]

RIN: 0970-AC15
_______________________________________________________________________




1042. [bull] CARE AND PLACEMENT OF UNACCOMPANIED ALIEN CHILDREN

Priority: Other Significant

Legal Authority: 6 USC 279

CFR Citation: 45 CFR 410

Legal Deadline: None

Abstract: This rule concerns the placement of unaccompanied alien 
children in appropriate facilities and homes, the services provided for 
the children while they are in the care of the Office of Refugee 
Resettlement (ORR) and the criteria for release of these children from 
Federal custody to sponsors. The rule also implements ORR's role in 
Flores class-action settlement agreement.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/00/05

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: Federal

Agency Contact: Maureen Dunn, Department of Health and Human Services, 
Administration for Children and Families, 370 L'Enfant Promenade SW., 
Washington, DC 20447
Phone: 202 401-5523
Email: [email protected]

RIN: 0970-AC20
_______________________________________________________________________




1043. [bull] CHAFEE NATIONAL YOUTH IN TRANSITION DATABASE

Priority: Other Significant

Legal Authority: 42 USC 677

CFR Citation: 45 CFR 1356

Legal Deadline: None

Abstract: This rule would require States to collect and report data on 
youth who are receiving independent living services and the outcomes of 
certain youth who are in foster care or who age-out of foster care.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/00/05

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: State

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

RIN: 0970-AC21

[[Page 26889]]

_______________________________________________________________________




1044. [bull] MEDICAL SUPPORT

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

Legal Authority: 42 USC 1302

CFR Citation: 45 CFR 302; 45 CFR 303; 45 CFR 304; 45 CFR 305

Legal Deadline: None

Abstract: These rules would require that all support orders in the IV-D 
program address medical support, redefine reasonable-cost health 
insurance, require health insurance to be accessible, and make 
conforming changes to audit and self-assessment requirements.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/00/05

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Governmental Jurisdictions

Government Levels Affected: Local, State

Agency Contact: Elizabeth C. Matheson, Director, Policy and Planning 
Division, Department of Health and Human Services, Administration for 
Children and Families, Office of Child Support Enforcement, 370 
L'Enfant Promenade SW., Washington, DC 20447
Phone: 202 401-9386
Email: [email protected]

RIN: 0970-AC22
_______________________________________________________________________


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


Administration for Children and Families (ACF)



_______________________________________________________________________




1045. ADMINISTRATIVE COSTS FOR CHILDREN IN TITLE IV-E FOSTER CARE

Priority: Other Significant

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

CFR Citation: 45 CFR 1356.60(c)

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            01/31/05                     70 FR 4803
Final Action                    09/00/05

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: State

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

RIN: 0970-AC14
_______________________________________________________________________




1046. HEAD START TRANSPORTATION

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

Legal Authority: 42 USC 9801 et seq

CFR Citation: 45 CFR 1310

Legal Deadline: None

Abstract: This final rule will extend for 150 days those parts of the 
Head Start transportation regulation that deal with the requirement 
that each vehicle used to transport children is equipped for use of 
child safety restraint systems and the requirement that each bus have a 
bus monitor. Additionally, these rules will provide Head Start grantees 
the opportunity to request further extension of the effective date when 
such an extension is in the best interest of the children they serve.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              01/16/04                     69 FR 2513
Final Action                    09/00/05

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Windy Hill, Associate Commissioner, 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
_______________________________________________________________________




1047. CHILD CARE AND DEVELOPMENT FUND STATE MATCH PROVISIONS

Priority: Other Significant

Legal Authority: 42 USC 9858C

CFR Citation: 45 CFR 98.16

Legal Deadline: None

Abstract: This proposed rule revises the Child Care and Development 
Fund (CCDF) regulations to permit States to designate multiple public 
and/or private entities as eligible to receive private donations that 
may be certified as child care expenditures for purposes of receiving 
Federal CCDF matching funds.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            11/09/04                    69 FR 64881
Final Action                    09/00/05

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: Local, State

Agency Contact: Karen Tvedt, Policy Director, Child Care Bureau, 
Department of Health and Human Services, Administration for Children 
and Families, 330 C Street SW., Room 2046, Washington, DC 20447
Phone: 202 401-5130
Email: [email protected]

RIN: 0970-AC18

[[Page 26890]]

_______________________________________________________________________




1048. REASONABLE QUANTITATIVE STANDARD FOR REVIEW AND ADJUSTMENT OF 
CHILD SUPPORT ORDERS

Priority: Other Significant

Legal Authority: 42 USC 1302

CFR Citation: 45 CFR 303

Legal Deadline: None

Abstract: This interim final rule permits States to use reasonable 
quantitative standards in adjusting an existing child support award 
amount after conducting review of the order, regardless of the method 
review.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              12/28/04                    69 FR 77659
Final Action                    09/00/05

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: Local, State

Agency Contact: Elizabeth C. Matheson, Director, Policy and Planning 
Division, Department of Health and Human Services, Administration for 
Children and Families, Office of Child Support Enforcement, 370 
L'Enfant Promenade SW., Washington, DC 20447
Phone: 202 401-9386
Email: [email protected]

RIN: 0970-AC19
_______________________________________________________________________


Department of Health and Human Services (HHS)         Completed Actions


Administration on Aging (AOA)



_______________________________________________________________________




1049. 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

CFR Citation: 45 CFR 1321; 45 CFR 1326; 45 CFR 1328

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn                       03/02/05

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses, Governmental Jurisdictions

Government Levels Affected: State, Tribal

Federalism:  Undetermined

Agency Contact: Edwin Walker
Phone: 202 401-4634

RIN: 0985-AA00
[FR Doc. 05-7660 Filed 05-13-05; 8:45 am]
BILLING CODE 4150-24-S
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