[December 13, 2004 (Volume 69, Number 238)] [Unified Agenda] From the Federal Register Online via GPO Access [frwais.access.gpo.gov] [DOCID: f:ua041208.wais] [Page 73120-73184] Department of Health and Human Services ----------------------------------------------------------------------- Part VIII ----------------------------------------------------------------------- Semiannual Regulatory Agenda [[Page 73120]] DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) _______________________________________________________________________ DEPARTMENT OF HEALTH AND HUMAN SERVICES Office of the Secretary 21 CFR Ch. I 42 CFR Chs. I-V 45 CFR Subtitle A; Subtitle B, Chs. II, III, and XIII Regulatory Agenda AGENCY: Office of the Secretary, HHS. ACTION: Semiannual agenda. _______________________________________________________________________ SUMMARY: The Regulatory Flexibility Act of 1980 and Executive Order 12866 require this semiannual publication inventorying all rulemaking actions under development by the Department. The purpose is to encourage public participation in the regulatory process by providing, at as early a stage as possible, summarized information about regulatory actions under consideration. Anyone wishing to communicate to the Department their views on the potential rulemakings outlined below is invited to do so. FOR FURTHER INFORMATION CONTACT: Ann C. Agnew, Executive Secretary, Department of Health and Human Services, Washington, DC 20201. SUPPLEMENTARY INFORMATION: The capsulized information provided below presents for public scrutiny a forecast of the rulemaking activities that the Department expects to undertake over the foreseeable future. When the Department publishes a proposed rule, information about it automatically becomes available to the public at www.regulations.gov, the Governmentwide Web site for submission of comments on proposed regulations. Citizens may submit comments on such proposals by clicking the ``Submit a Comment on this Regulation'' link on the Web site, which will open a blank comment form containing instructions on how to submit the comment. Comments submitted via www.regulations.gov are transmitted to the Department daily, and, as legally required, all comments received are reviewed and taken into account if a final regulation is developed. We welcome the views of all concerned with regard to the planned rulemakings referenced below. Comments may be directed to the agency officials cited in each of the summaries, or, if early attention at the Secretary's level is seen as required, comments should be sent to Ann C. Agnew, Executive Secretary to the Department, Room 603H, 200 Independence Avenue SW., Washington DC 20201. For this edition of the Department of Health and Human Services' regulatory agenda, the most significant regulatory actions are included in The Regulatory Plan, which appears in part II of this issue of the Federal Register. The Regulatory Plan entries are listed in the table of contents below and are denoted by a bracketed bold reference, which directs the reader to the appropriate sequence in part II. Dated: November 1, 2004. Ann C. Agnew, Executive Secretary to the Department. Office of the Secretary--Proposed Rule Stage ---------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Number Number ---------------------------------------------------------------------------------------------------------------- 910 Health Insurance Portability and Accountability Act--Enforcement...................... 0991-AB29 ---------------------------------------------------------------------------------------------------------------- Office of the Secretary--Final Rule Stage ---------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Number Number ---------------------------------------------------------------------------------------------------------------- 911 Shared Risk Exception to the Safe Harbor Provisions................................... 0991-AA91 912 Amending the Regulations Governing Nondiscrimination on the Basis of Race, Color, 0991-AB10 National Origin, Handicap, Sex, and Age To Conform to the Civil Rights Restoration Act of 1987............................................................................... 913 Safe Harbor for Waiver of Beneficiary Coinsurance and Deductible Amounts for a 0991-AB16 Medicare SELECT Policy................................................................ 914 Clarification of Terms and Application of Program Exclusion Authority for Submitting 0991-AB23 Claims Containing Excessive Charges................................................... ---------------------------------------------------------------------------------------------------------------- Office of the Secretary--Long-Term Actions ---------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Number Number ---------------------------------------------------------------------------------------------------------------- 915 Revisions to Regulations Addressing the OIG's Authority to Impose Civil Money 0991-AB03 Penalties and Assessments............................................................. 916 Claims Collection..................................................................... 0991-AB18 917 Salary Offset......................................................................... 0991-AB19 918 Medicare and Federal Health Care Programs: Fraud and Abuse; Revisions to the Waiver 0991-AB33 Provisions of the OIG's Exclusion Authorities......................................... ---------------------------------------------------------------------------------------------------------------- [[Page 73121]] Office of the Secretary--Completed Actions ---------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Number Number ---------------------------------------------------------------------------------------------------------------- 919 Safe Harbor for Arrangements Involving Federally Qualified Health Centers............. 0991-AB06 920 Technical Revisions to HIPDB Data Collection Activities............................... 0991-AB31 921 Participation in Department of Health and Human Services Programs by Religious 0991-AB34 Organizations; Providing for Equal Treatment of All Department of Health and Human Services Program Participants......................................................... ---------------------------------------------------------------------------------------------------------------- Substance Abuse and Mental Health Services Administration--Proposed Rule Stage ---------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Number Number ---------------------------------------------------------------------------------------------------------------- 922 Requirements Governing the Use of Seclusion and Restraint in Certain Nonmedical 0930-AA10 Community-Based Facilities for Children and Youth..................................... ---------------------------------------------------------------------------------------------------------------- Substance Abuse and Mental Health Services Administration--Final Rule Stage ---------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Number Number ---------------------------------------------------------------------------------------------------------------- 923 Mandatory Guidelines for the Federal Workplace Drug Testing Program................... 0930-AA12 ---------------------------------------------------------------------------------------------------------------- Centers for Disease Control and Prevention--Proposed Rule Stage ---------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Number Number ---------------------------------------------------------------------------------------------------------------- 924 Amendments to Quality Assurance and Administrative Provision for Approval of 0920-AA04 Respiratory Protective Devices........................................................ ---------------------------------------------------------------------------------------------------------------- Centers for Disease Control and Prevention--Final Rule Stage ---------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Number Number ---------------------------------------------------------------------------------------------------------------- 925 Possession, Use, and Transfer of Select Agents and Toxins............................. 0920-AA09 ---------------------------------------------------------------------------------------------------------------- Food and Drug Administration--Prerule Stage ---------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Number Number ---------------------------------------------------------------------------------------------------------------- 926 Food Labeling; Prominence of Calories (Reg Plan Seq No. 41)........................... 0910-AF22 927 Food Labeling; Serving Sizes of Products That Can Reasonably Be Consumed at One Eating 0910-AF23 Occasion; Updating of Reference Amounts Customarily Consumed; Approaches for Recommending Smaller Portion Sizes (Reg Plan Seq No. 42).............................. 928 Over-the-Counter (OTC) Drug Review--Sunscreen Products................................ 0910-AF43 ---------------------------------------------------------------------------------------------------------------- References in boldface appear in the Regulatory Plan in part II of this issue of the Federal Register. Food and Drug Administration--Proposed Rule Stage ---------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Number Number ---------------------------------------------------------------------------------------------------------------- 929 Foreign and Domestic Establishment Registration and Listing Requirements for Human 0910-AA49 Drugs, Certain Biological Drugs, and Animal Drugs (Reg Plan Seq No. 43)............... [[Page 73122]] 930 Medical Devices; Anesthesiology Devices; Proposed Reclassification of Pressure 0910-AC30 Regulators for Use With Medical Oxygen................................................ 931 Submission of Standardized Electronic Study Data From Clinical Studies Evaluating 0910-AC52 Human Drugs and Biologics............................................................. 932 Medical Gas Containers and Closures; Current Good Manufacturing Practice Requirements. 0910-AC53 933 Food Standards: General Principles and Food Standards Modernization................... 0910-AC54 934 Positron Emission Tomography Drugs; Current Good Manufacturing Practices.............. 0910-AC55 935 Reporting Information Regarding Falsification of Data................................. 0910-AC59 936 Health Claims......................................................................... 0910-AF09 937 Quality Standard Regulation Establishing an Allowable Level for Arsenic in Bottled 0910-AF10 Water................................................................................. 938 Content and Format of Labeling for Human Prescription Drugs and Biologics; 0910-AF11 Requirements for Pregnancy and Lactation.............................................. 939 Cochineal Extract and Carmine Label Declaration....................................... 0910-AF12 940 Charging for Investigational Drugs.................................................... 0910-AF13 941 Treatment Use of Investigational Drugs................................................ 0910-AF14 942 Distribution of Blood Derivatives by Registered Blood Establishments That Qualify as 0910-AF16 Health Care Entities; PDMA of 1987; PDA of 1992; Policies, Requirements, and Administrative Procedures............................................................. 943 Revocation of the Status of Specific Products; Group A Streptococcus.................. 0910-AF20 944 Obstetrical and Gynecological Devices; Designation of Special Control for Condoms and 0910-AF21 Condoms with Spermicidal Lubricant.................................................... 945 Blood Initiative--Requirements for Human Blood and Blood Components Intended for 0910-AF25 Transfusion or for Further Manufacturing Use.......................................... 946 Over-the-Counter (OTC) Drug Review--Cough/Cold (Bronchodilator) Products.............. 0910-AF32 947 Over-the-Counter (OTC) Drug Review--Cough/Cold (Combination) Products................. 0910-AF33 948 Over-the-Counter (OTC) Drug Review--Cough/Cold (Nasal Decongestant) Products.......... 0910-AF34 949 Over-the-Counter (OTC) Drug Review--Internal Analgesic Products....................... 0910-AF36 950 Over-the-Counter (OTC) Drug Review--Labeling of Drug Products for OTC Human Use....... 0910-AF37 951 Over-the-Counter (OTC) Drug Review--Weight Control Products........................... 0910-AF45 952 Substances Prohibited From Use in Animal Food or Feed (Reg Plan Seq No. 44)........... 0910-AF46 953 Over-the-Counter (OTC) Drug Review--Dandruff, Seborrheic Dermatitis, and Psoriasis 0910-AF49 Products.............................................................................. 954 Over-the-Counter (OTC) Drug Review--Overindulgence in Food and Drink Products......... 0910-AF51 955 Over-the-Counter (OTC) Drug Review--Skin Bleaching Prodcuts........................... 0910-AF53 956 Use of Materials Derived From Cattle In Human and Animal Medical Products (Reg Plan 0910-AF54 Seq No. 45)........................................................................... 957 Requirements for Human and Animal Medical Products Manufactured From, Processed With, 0910-AF55 or Otherwise Containing Material From Cattle (Reg Plan Seq No. 46).................... ---------------------------------------------------------------------------------------------------------------- References in boldface appear in the Regulatory Plan in part II of this issue of the Federal Register. Food and Drug Administration--Final Rule Stage ---------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Number Number ---------------------------------------------------------------------------------------------------------------- 958 Investigational New Drugs: Export Requirements for Unapproved New Drug Products....... 0910-AA61 959 Requirements on Content and Format of Labeling for Human Prescription Drugs and 0910-AA94 Biological Products (Reg Plan Seq No. 47)............................................. 960 Safety Reporting Requirements for Human Drug and Biological Products (Reg Plan Seq No. 0910-AA97 48)................................................................................... 961 Current Good Tissue Practice for Human Cell, Tissue, and Cellular and Tissue-Based 0910-AB28 Product Establishments; Inspection and Enforcement (Reg Plan Seq No. 49).............. 962 Applications for FDA Approval To Market a New Drug; Complete Response Letter; 0910-AB34 Amendments To Unapproved Applications................................................. 963 CGMPs for Blood and Blood Components: Notification of Consignees and Transfusion 0910-AB76 Recipients Receiving Blood and Blood Components at Increased Risk of Transmitting HCV Infection (Lookback) (Reg Plan Seq No. 50)............................................ 964 Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Dietary 0910-AB88 Ingredients and Dietary Supplements (Reg Plan Seq No. 51)............................. 965 Additional Safeguards for Children in Clinical Investigations of FDA-Regulated 0910-AC07 Products.............................................................................. 966 Prevention of Salmonella Enteritidis in Shell Eggs (Reg Plan Seq No. 52).............. 0910-AC14 967 Institutional Review Boards: Registration Requirements................................ 0910-AC17 968 Medical Devices; Patient Examination and Surgeons' Gloves; Adulteration............... 0910-AC32 [[Page 73123]] 969 Amendments to the Performance Standard for Diagnostic X-Ray Systems and Their Major 0910-AC34 Components............................................................................ 970 Toll-Free Number for Reporting Adverse Events on Labeling for Human Drugs (Reg Plan 0910-AC35 Seq No. 53)........................................................................... 971 Establishment and Maintenance of Records Pursuant to the Public Health Security and 0910-AC39 Bioterrorism Preparedness and Response Act of 2002 (Reg Plan Seq No. 54).............. 972 Registration of Food and Animal Feed Facilities (Reg Plan Seq No. 55)................. 0910-AC40 973 Prior Notice of Imported Food Under the Public Health Security and Bioterrorism 0910-AC41 Preparedness and Response Act of 2002 (Reg Plan Seq No. 56)........................... 974 Human Subject Protection; Foreign Clinical Studies Not Conducted Under an 0910-AF15 Investigational New Drug Application.................................................. 975 Use of Ozone-Depleting Substances: Removal of Essential Use Designation; Albuterol 0910-AF18 (Reg Plan Seq No. 57)................................................................. 976 Blood Initiative--Revisions to Labeling and Storage Requirements for Blood and Blood 0910-AF26 Components, Including Source Plasma................................................... 977 Current Good Manufacturing Practices; Quality Control Procedures; Notification 0910-AF27 Requirements; Records and Reports..................................................... 978 Infant Formula Quality Factors........................................................ 0910-AF28 979 Over-the-Counter (OTC) Drug Review--Cough/Cold (Antihistamine) Products............... 0910-AF31 980 Over-the-Counter (OTC) Drug Review--Ophthalmic Products............................... 0910-AF39 981 Over-the-Counter (OTC) Drug Review--Skin Protectant Products.......................... 0910-AF42 982 Over-the-Counter (OTC) Drug Review--Vaginal Contraceptive Products.................... 0910-AF44 983 Use of Materials Derived From Cattle in Human Food and Cosmetics (Reg Plan Seq No. 58) 0910-AF47 984 Recordkeeping Requirements for Human Food and Cosmetics Manufactured From, Processed 0910-AF48 With, or Otherwise Containing Material From Cattle (Reg Plan Seq No. 59).............. 985 Over-the-Counter (OTC) Drug Review--Antacid Products (Sodium Bicarbonate Labeling).... 0910-AF52 ---------------------------------------------------------------------------------------------------------------- References in boldface appear in the Regulatory Plan in part II of this issue of the Federal Register. Food and Drug Administration--Long-Term Actions ---------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Number Number ---------------------------------------------------------------------------------------------------------------- 986 Requirements Pertaining to Sampling Services and Private Laboratories Used in 0910-AB96 Connection With Imported Food......................................................... 987 Chronic Wasting Disease: Control of Food Products and Cosmetics Derived From Exposed 0910-AC21 Animal Populations.................................................................... 988 Requirements for Submission of In Vivo Bioequivalence Data............................ 0910-AC23 989 Exception From General Requirements for Informed Consent; Request for Comments and 0910-AC25 Information........................................................................... 990 Food Labeling: Trans Fatty Acids in Nutrition Labeling: Consumer Research To Consider 0910-AC50 Nutrient Content and Health Claims and Possible Footnote or Disclosure Statements..... 991 Food Labeling: Food Allergen Ingredient Labeling...................................... 0910-AF07 992 Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding 0910-AF08 of Drugs; Revision of Certain Labeling Controls....................................... 993 Over-the-Counter (OTC) Drug Review--External Analgesic Products....................... 0910-AF35 994 Over-the-Counter (OTC) Drug Review--Laxative Drug Products............................ 0910-AF38 995 Over-the-Counter (OTC) Drug Review--Oral Health Care Products......................... 0910-AF40 ---------------------------------------------------------------------------------------------------------------- Food and Drug Administration--Completed Actions ---------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Number Number ---------------------------------------------------------------------------------------------------------------- 996 Presubmission Conferences............................................................. 0910-AC44 997 Definition of ``Serious Adverse Health Consequences'' Under the Public Health Security 0910-AF06 and Bioterrorism Preparedness and Response Act of 2002................................ 998 Over-the-Counter (OTC) Drug Review--Antiperspirant Products........................... 0910-AF30 999 Over-the-Counter (OTC) Drug Review--Sodium Labeling for Over-the Counter Drugs........ 0910-AF50 ---------------------------------------------------------------------------------------------------------------- [[Page 73124]] Health Resources and Services Administration--Proposed Rule Stage ---------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Number Number ---------------------------------------------------------------------------------------------------------------- 1000 National Practitioner Data Bank for Adverse Information on Physicians and Other Health 0906-AA41 Care Practitioners: Medical Malpractice Payments Reporting Requirements............... 1001 Designation of Medically Underserved Populations and Health Professional Shortage 0906-AA44 Areas................................................................................. 1002 Intestines Added to the Definition of Organs Covered by the Rules Governing the 0906-AA62 Operation of the Organ Procurement and Transplantation Network (OPTN)................. 1003 National Vaccine Injury Compensation Program; Revisions and Additions to the Vaccine 0906-AA66 Injury Table.......................................................................... 1004 National Vaccine Injury Compensation Program: Calculation of Average Cost of a Health 0906-AA68 Insurance Policy...................................................................... 1005 Revision to 42 CFR Subpart D--Public Health Service (PHS) Grant Appeals Procedure..... 0906-AA69 1006 Healthy Tomorrow's Partnership for Children (HTPC) Program............................ 0906-AA70 ---------------------------------------------------------------------------------------------------------------- Health Resources and Services Administration--Final Rule Stage ---------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Number Number ---------------------------------------------------------------------------------------------------------------- 1007 Interim Final Rule for the Smallpox Emergency Personnel Protection Program: Smallpox 0906-AA60 (Vaccinia) Vaccine Injury Table....................................................... 1008 Smallpox Vaccine Injury Compensation Program: Administrative Implementation........... 0906-AA61 1009 Requirements Establishing a Limitation on Administrative Expenses; Ryan White CARE Act 0906-AA65 Title IV Grants for Coordinated Services and Access to Research....................... ---------------------------------------------------------------------------------------------------------------- Health Resources and Services Administration--Long-Term Actions ---------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Number Number ---------------------------------------------------------------------------------------------------------------- 1010 National Practitioner Data Bank for Adverse Information on Physicians and Other Health 0906-AA57 Care Practitioners: Reporting Adverse and Negative Actions............................ 1011 Operation of the Organ Procurement and Transplantation Network (OPTN)................. 0906-AA63 ---------------------------------------------------------------------------------------------------------------- Health Resources and Services Administration--Completed Actions ---------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Number Number ---------------------------------------------------------------------------------------------------------------- 1012 Liability Protection for Certain Free Clinic Health Professionals..................... 0906-AA67 ---------------------------------------------------------------------------------------------------------------- National Institutes of Health--Proposed Rule Stage ---------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Number Number ---------------------------------------------------------------------------------------------------------------- 1013 Undergraduate Scholarship Program Regarding Professions Needed by the National 0925-AA10 Institutes of Health (NIH)............................................................ 1014 National Institutes of Health Training Grants......................................... 0925-AA28 1015 Standards for a National Chimpanzee Sanctuary System.................................. 0925-AA31 1016 National Institutes of Health AIDS Research Loan Repayment Program.................... 0925-AA32 1017 National Institutes of Health Extramural Loan Repayment Program for Clinical 0925-AA33 Researchers........................................................................... 1018 National Institutes of Health Pediatric Research Loan Repayment Program............... 0925-AA34 1019 National Institutes of Health Loan Repayment Program for Health Disparities Research.. 0925-AA35 1020 National Institutes of Health Clinical Research Loan Repayment Program for Individuals 0925-AA36 From Disadvantaged Backgrounds........................................................ 1021 National Institute of Child Health and Human Development Contraception and Infertility 0925-AA41 Research Loan Repayment Program....................................................... ---------------------------------------------------------------------------------------------------------------- [[Page 73125]] National Institutes of Health--Final Rule Stage ---------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Number Number ---------------------------------------------------------------------------------------------------------------- 1022 National Institutes of Health Loan Repayment Program for Research Generally........... 0925-AA18 ---------------------------------------------------------------------------------------------------------------- National Institutes of Health--Completed Actions ---------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Number Number ---------------------------------------------------------------------------------------------------------------- 1023 National Institutes of Health Center Grants........................................... 0925-AA24 ---------------------------------------------------------------------------------------------------------------- Office of Public Health and Science--Prerule Stage ---------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Number Number ---------------------------------------------------------------------------------------------------------------- 1024 Human Subjects Protection Regulations: Additional Protections for Adult Individuals 0940-AA11 With Impaired Decisionmaking Capacity................................................. ---------------------------------------------------------------------------------------------------------------- Office of Public Health and Science--Final Rule Stage ---------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Number Number ---------------------------------------------------------------------------------------------------------------- 1025 Public Health Service Standards for the Protection of Research Misconduct 0940-AA01 Whistleblowers........................................................................ 1026 Public Health Service Policies on Research Misconduct................................. 0940-AA04 1027 Human Subjects Protection Regulations: Institutional Review Boards Registration 0940-AA06 Requirements.......................................................................... 1028 Federal Policy for the Protection of Human Subjects Technical Amendment............... 0940-AA10 ---------------------------------------------------------------------------------------------------------------- Office of Public Health and Science--Long-Term Actions ---------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Number Number ---------------------------------------------------------------------------------------------------------------- 1029 Human Subjects Protection Regs.: Training and Education Requirements for Institutional 0940-AA08 Officials, Institutional Review Board Members and Staff, Human Protections Administrators, and Investigators..................................................... ---------------------------------------------------------------------------------------------------------------- Centers for Medicare & Medicaid Services--Proposed Rule Stage ---------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Number Number ---------------------------------------------------------------------------------------------------------------- 1030 Home Health Agency (HHA) Conditions of Participation (CoPs) (CMS-3819-P).............. 0938-AG81 1031 End Stage Renal Disease (ESRD) Conditions for Coverage (CMS-3818-P) (Section 610 0938-AG82 Review) (Reg Plan Seq No. 60)......................................................... 1032 Hospital Conditions of Participation: Requirements for Approval and Reapproval of 0938-AH17 Transplant Centers To Perform Organ Transplants (CMS-3835-P) (Reg Plan Seq No. 61).... 1033 Hospice Care--Conditions of Participation (CMS-3844-P) (Reg Plan Seq No. 62).......... 0938-AH27 1034 Standard Unique National Health Plan Identifiers (CMS-6017-P)......................... 0938-AH87 1035 Appeals of Carrier Determination That a Supplier Fails To Meet the Requirements for 0938-AI49 Medicare Billing Privileges (CMS-6003-P2)............................................. 1036 Rural Health Clinics: Amendments to Participation Requirements and Payment Provisions 0938-AJ17 and Establishment of a Quality Assessment and Improvement Program (CMS-1910-P2)....... 1037 Supplier Standards for Home Oxygen, Therapeutic Shoes, and Home Nutrition Therapy (CMS- 0938-AJ98 6010-P)............................................................................... 1038 Standards for Electronic Health Care Claim Attachments(CMS-0050-P).................... 0938-AK62 1039 Organ Procurement Organization Conditions for Coverage (CMS-3064-P) (Reg Plan Seq No. 0938-AK81 63)................................................................................... [[Page 73126]] 1040 Use of Restraint and Seclusion in Medicare and Medicaid Participating Facilities That 0938-AL26 Provide Inpatient or Residential Care (CMS-2130-P) (Reg Plan Seq No. 64).............. 1041 Revisions to Conditions for Coverage for Ambulatory Surgical Centers (CMS-3887-P)..... 0938-AL80 1042 Health Coverage Portability: Tolling Certain Time Periods and Interactions With Family 0938-AL88 and Medical Leave Act (CMS-2158-P).................................................... 1043 Modifications to Electronic Transactions and Code Sets (CMS-0009-P)................... 0938-AM50 1044 Requirements for Long-Term Care Facilities: Hospice Services (CMS-3140-P)............. 0938-AM87 1045 Hospital Conditions of Participation: Requirements for History and Physical 0938-AM88 Examinations; Authentication of Verbal Orders; Securing Medications; and Post- Anesthesia Evaluations (CMS-3122-P)................................................... 1046 Physician Referral for Nuclear Medicine Services and Supplies (CMS-1261-P)............ 0938-AN04 1047 Enhanced DSH Treatment for Certain Hospitals (CMS-2198-P)............................. 0938-AN09 1048 Prior Determination Process for Certain Items and Services (CMS-6024-P)............... 0938-AN10 1049 Competitive Acquisition for Certain Durable Medical Equipment (DME), Prosthetics, 0938-AN14 Orthotics, and Supplies (CMS-1270-P).................................................. 1050 Update of the List of Covered Procedures for Ambulatory Surgical Centers for 2005 (CMS- 0938-AN23 1478-PN).............................................................................. 1051 Revisions to HIPAA Code Sets (CMS-0013-P)............................................. 0938-AN25 1052 Payment for Clinical Laboratory Tests (CMS-1494-P).................................... 0938-AN26 1053 Prospective Payment System for Long Term Care Hospitals: Annual Payment Rate Updates 0938-AN28 and Policy Changes for 2006 (CMS-1483-P).............................................. 1054 Random Prepayment Review (CMS-6022-P)................................................. 0938-AN31 1055 Repayment Plans and Limitation on Recoupment of Overpayments (CMS-6025-P)............. 0938-AN42 1056 Prospective Payment System for Inpatient Rehabilitation Facilities for FY 2006 (CMS- 0938-AN43 1290-P)............................................................................... 1057 Home Health Prospective Payment System Rate Update for Calendar Year 2006 (CMS-1301-P) 0938-AN44 1058 Changes to the Hospital Outpatient Prospective Payment System and Calendar Year 2006 0938-AN46 Payment Rates (CMS-1501-P)............................................................ 1059 Revised Civil Money Penalties, Assessments, Exclusions, and Related Appeals Procedures 0938-AN48 (CMS-6019-P).......................................................................... 1060 Medicare Modernization Act; Electronic Prescribing (CMS-0011-P)....................... 0938-AN49 1061 Furnishing Hospitals With Information To Compute the Disproportionate Share Hospital 0938-AN52 Formula (CMS-1283-P).................................................................. 1062 End Stage Renal Disease (ESRD) Composite Rate Exception (CMS-1278-P).................. 0938-AN53 1063 Changes to the Hospital Inpatient Prospective Payment System and FY 2006 Rates (CMS- 0938-AN57 1500-P)............................................................................... 1064 Medicare Part B Competitive Acquisition of Outpatient Drugs and Biologicals (CMS-1325- 0938-AN58 P).................................................................................... 1065 Revisions to the Oversight and Validation Program for Accrediting Organizations 0938-AN62 Approved for Deeming Authority (CMS-2255-P) (Reg Plan Seq No. 65)..................... 1066 Special Payment Provisions and Standards for Suppliers of Custom Fabricated Orthotics 0938-AN63 and Prosthetics (CMS-6012-P).......................................................... 1067 Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities-- 0938-AN65 Update for FY 2006 (CMS-1282-P)....................................................... ---------------------------------------------------------------------------------------------------------------- References in boldface appear in the Regulatory Plan in part II of this issue of the Federal Register. Centers for Medicare & Medicaid Services--Final Rule Stage ---------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Number Number ---------------------------------------------------------------------------------------------------------------- 1068 Hospital Conditions of Participation: Laboratory Services (CMS-3014-IFC).............. 0938-AJ29 1069 Health Coverage Portability for Group Health Plans and Group Health Insurance Issuers 0938-AL43 (CMS-2151-F).......................................................................... 1070 Prospective Payment System for Inpatient Psychiatric Facilities for FY 2004 (CMS-1213- 0938-AL50 F).................................................................................... 1071 Request for Information on Benefit-Specific Waiting Periods (CMS-2150-NC)............. 0938-AL64 1072 Revisions to the Medicare Appeals Process (CMS-4004-FC)............................... 0938-AL67 1073 Revisions to the Appeals Process for Initial Claim Determinations (CMS-4064-IFC)...... 0938-AM73 1074 Conditions for Coverage of Power Mobility Devices, including Powered Wheelchairs and 0938-AM74 Power-Operated Vehicles Scooter(CMS-3017-IFC)......................................... 1075 Changes to the Hospital Outpatient Prospective System and Calendar Year 2005 Payment 0938-AM75 Rates (CMS-1427-FC)................................................................... 1076 Revisions to Payment Policies Under the Physician Fee Schedule for Calendar Year 2005 0938-AM90 (CMS-1429-FC)......................................................................... 1077 Medicare Advantage Program--Title II (CMS-4069-F) (Reg Plan Seq No. 66)............... 0938-AN06 1078 Medicare Drug Benefit Effective Calendar Year 2006--Title I (CMS-4068-F) (Reg Plan Seq 0938-AN08 No. 67)............................................................................... 1079 Schedule for Publishing Medicare Final Regulations After a Proposed or Interim Final 0938-AN12 Regulation (CMS-9026-N)............................................................... 1080 Evaluation Criteria and Standards for Quality Improvement Program Contracts (CMS-3142- 0938-AN13 NC)................................................................................... [[Page 73127]] 1081 Medicare Secondary Payer (MSP): Workmen's Compensation (CMS-6272-IFC)................. 0938-AN27 1082 Fire Safety Requirements for Certain Health Care Facilities; Alcohol-Based Hand 0938-AN36 Sanitizer Amendment (CMS-3145-IFC).................................................... 1083 Modifications to Managed Care Rules (CMS-4041-IFC).................................... 0938-AN38 1084 Development of New Standards for Medigap Policies (CMS-2197-FN)....................... 0938-AN50 1085 Time Limitation on Recordkeeping Requirements Under the Drug Rebate Program (CMS-2175- 0938-AN55 F).................................................................................... 1086 Fiscal Year 2006 SCHIP Allotments (CMS-2219-N)........................................ 0938-AN56 ---------------------------------------------------------------------------------------------------------------- References in boldface appear in the Regulatory Plan in part II of this issue of the Federal Register. Centers for Medicare & Medicaid Services--Long-Term Actions ---------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Number Number ---------------------------------------------------------------------------------------------------------------- 1087 Requirements for Establishing and Maintaining Medicare Billing Privileges (CMS-6002-F) 0938-AH73 1088 Medicare Outcome and Assessment Information Set (OASIS) Data Reporting Requirements 0938-AJ10 (CMS-3006-F).......................................................................... 1089 Medicare Hospice Care Amendments (CMS-1022-F)......................................... 0938-AJ36 1090 Use of Restraint and Seclusion in Residential Treatment Facilities Providing Inpatient 0938-AJ96 Psychiatric Services to Individuals Under Age 21 (CMS-2065-F)......................... 1091 Physicians' Referrals to Health Care Entities With Which They Have Financial 0938-AK67 Relationships--Phase II (CMS-1810-IFC)................................................ 1092 Provider Reimbursement Determinations and Appeals (CMS-1727-F)........................ 0938-AL54 1093 DMERC Service Areas and Related Matters (CMS-1219-F).................................. 0938-AL76 1094 Electronic Medicare Claims Submission (CMS-0008-F).................................... 0938-AM22 1095 Procedures for Maintaining Code Lists in the Negotiated National Coverage 0938-AM36 Determinations for Clinical Diagnostic Laboratory Services (CMS-3119-FN).............. 1096 Requirements for Long Term Care Facilities; Nursing Services; Posting of Nurse 0938-AM55 Staffing Information (CMS-3121-F)..................................................... 1097 Revised Civil Money Penalties, Assessments, Exclusions, and Related Appeals Procedures 0938-AM98 (CMS-6146-F).......................................................................... 1098 Payment for Respiratory Assist Devices With Bi-Level Capability and a Back-Up Rate 0938-AN02 (CMS-1167-F).......................................................................... 1099 Nondiscrimination In Post-Hospital Referral to Home Health Agencies and Other Entities 0938-AN19 (CMS-1224-F).......................................................................... 1100 Medicare Ambulance Fee Schedule Update (CMS-1492-F)................................... 0938-AN24 1101 Nondiscrimination in Health Coverage and Wellness Plans in the Group Market (CMS-2022- 0938-AN29 F).................................................................................... 1102 Hospital Conditions of Participation: Patients' Rights (CMS-3018-F)................... 0938-AN30 1103 Federal Enforcement in Group and Individual Health Insurance Markets (CMS-2019-F)..... 0938-AN35 1104 Group Market Health Insurance Reform: Guaranteed Availability, Guaranteed 0938-AN60 Renewability, Disclosures to Small Employers (CMS-2216-F)............................. 1105 Individual Market Health Insurance Reform: Portability From Group to Individual 0938-AN61 Coverage; Federal Rules for Access in the Individual Market; State Alternative Mechanisms to Federal Rules (CMS-2217-F).............................................. ---------------------------------------------------------------------------------------------------------------- Centers for Medicare & Medicaid Services--Completed Actions ---------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Number Number ---------------------------------------------------------------------------------------------------------------- 1106 Continuation of Medicare Entitlement When Disability Benefit Ends Because of 0938-AK94 Substantial Gainful Activity (CMS-4018-F)............................................. 1107 Interest Calculation (CMS-6014-F)..................................................... 0938-AL14 1108 Hospital Patients' Rights CoP--Standard Safety Compliance Committees (CMS-3120-P)..... 0938-AM39 1109 Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities-- 0938-AM46 Update for FY 2006 (CMS-1249-N)....................................................... 1110 Title I: Non-Federal Governmental Plans Exempt From HIPAA (CMS-2033-F)................ 0938-AM71 1111 Hospice Wage Index FY 2005 (CMS-1264-N)............................................... 0938-AM78 1112 Ticket to Work: Defining Individuals with Potentially Severe Disabilities and 0938-AM79 Providing a Work Threshold (CMS-2172-P)............................................... 1113 Changes to the Hospital Inpatient Prospective Payment System and FY 2005 Rates (CMS- 0938-AM80 1428-F)............................................................................... 1114 Covered Outpatient Drugs Under the Medicaid Drug Rebate Program (CMS-2174-P).......... 0938-AM81 [[Page 73128]] 1115 Prospective Payment System for Inpatient Rehabilitation Facilities for FY 2005 (CMS- 0938-AM82 1360-N)............................................................................... 1116 Payment Error Rate Measurement (PERM) Program (CMS-6026-P)............................ 0938-AM86 1117 Home Health Prospective Payment System Rate Update FY 2005 (CMS-1265-F)............... 0938-AM93 1118 Revisions to Cost Sharing Regulations (CMS-2144-P).................................... 0938-AM94 1119 Medicare Program; Hospital Outpatient Prospective Payment System Payment Reform for 0938-AM96 Calendar Year 2004 CMS-1371-F......................................................... 1120 Changes to Medicare Payment for Drugs and Physician Fee Schedule Payments for Calendar 0938-AM97 Year 2004--Correction Notice CMS-1372-F).............................................. 1121 Physicians' Referrals to Health Care Entities With Which They Have Financial 0938-AM99 Relationships: Extension of Partial Delay of Effective Date (CMS-1809-F5)............. 1122 Time Limitation on Recordkeeping Requirements Under the Drug Rebate Program (CMS-2188- 0938-AN01 P).................................................................................... 1123 Extended Availability of Unexpended SCHIP Funds From the Appropriation for FYs 1998 0938-AN03 Through 2004; Authority To Use a Portion of SCHIP Funds for Medicaid Expenditures (CMS- 2187-N)............................................................................... 1124 Manufacturers' Submission of Average Sales Price Data for Medicare Part B Drugs and 0938-AN05 Biologicals (CMS-1380-F).............................................................. 1125 Special Rules for Employer-Sponsored Drug Programs: Subsidies To Encourage Retention 0938-AN07 (Title I) (CMS-2199-P)................................................................ 1126 FY 2005 SCHIP Allotments (CMS-2201-N)................................................. 0938-AN11 1127 Part A Premiums for Calendar Year 2005 for the Uninsured Aged and for Certain Disabled 0938-AN15 Individuals Who Have Exhausted Other Entitlement (CMS-8022-N)......................... 1128 Inpatient Hospital Deductible and Hospital and Extended Care Services Coinsurance 0938-AN16 Amounts for Calendar Year 2005 (CMS-8021-N)........................................... 1129 Medicare Part B Monthly Actuarial Rates and Premium Rate Beginning January 1, 2005 0938-AN18 (CMS-8020-N).......................................................................... 1130 Fee Schedule for Payment of Ambulance Services-Update for Calendar Year 2005 (CMS-1267- 0938-AN20 N).................................................................................... 1131 Procedure for Producing Guidance Documents Describing Medicare's Coverage Process (CMS- 0938-AN21 3141-N)............................................................................... 1132 Amendment to the Interim Final Regulation for Mental Health Parity (CMS-2152-F2)...... 0938-AN22 1133 Pharmacy Dispensing Fee (CMS-1280-F).................................................. 0938-AN34 ---------------------------------------------------------------------------------------------------------------- Administration for Children and Families--Proposed Rule Stage ---------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Number Number ---------------------------------------------------------------------------------------------------------------- 1134 Safeguarding Child Support and Expanded Federal Parent Locator Services (FPLS) 0970-AC01 Information........................................................................... 1135 Developmental Disabilities and Bill of Rights Act..................................... 0970-AC07 1136 Administrative Costs for Children in Title IV-E Foster Care........................... 0970-AC14 1137 Administrative Cost Sharing Under TANF................................................ 0970-AC15 1138 Child Care and Development Fund State Match Provisions................................ 0970-AC18 ---------------------------------------------------------------------------------------------------------------- Administration for Children and Families--Final Rule Stage ---------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Number Number ---------------------------------------------------------------------------------------------------------------- 1139 Head Start Transportation............................................................. 0970-AC16 1140 Reasonable Quantitative Standard for Review and Adjustment of Child Support Orders.... 0970-AC19 ---------------------------------------------------------------------------------------------------------------- Administration for Children and Families--Completed Actions ---------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Number Number ---------------------------------------------------------------------------------------------------------------- 1141 Child Support Enforcement Program; Federal Tax Refund Offset.......................... 0970-AC09 ---------------------------------------------------------------------------------------------------------------- [[Page 73129]] Administration on Aging--Proposed Rule Stage ---------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Number Number ---------------------------------------------------------------------------------------------------------------- 1142 Grants for State and Community Programs on Aging, Training, Research, and 0985-AA00 Discretionary Programs; Vulnerable Elder Rights; Grants to Indians and Native Hawaiians............................................................................. ---------------------------------------------------------------------------------------------------------------- _______________________________________________________________________ Department of Health and Human Services (HHS) Proposed Rule Stage Office of the Secretary (OS) _______________________________________________________________________ 910. HEALTH INSURANCE PORTABILITY AND ACCOUNTABILITY ACT--ENFORCEMENT Priority: Other Significant. Major status under 5 USC 801 is undetermined. Legal Authority: Subtitle F of title II of PL 104-191; 42 USC 1320d-5 CFR Citation: 45 CFR 160, subparts C to E Legal Deadline: None Abstract: This rulemaking would seek to establish a framework for enforcing compliance with the ``administrative simplification'' provisions of the Health Insurance Portability and Accountability Act (HIPAA) of 1996 -- subtitle F of title II of Public Law 104-191, through the imposition of civil money penalties under 42 USC 1320d-5. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 02/00/05 Regulatory Flexibility Analysis Required: No Small Entities Affected: Businesses Government Levels Affected: None Agency Contact: Carol Conrad, Department of Health and Human Services, Room 5347, Office of the General Counsel, 330 Independence Avenue SW., Washington, DC 20201 Phone: 202 690-1840 RIN: 0991-AB29 _______________________________________________________________________ Department of Health and Human Services (HHS) Final Rule Stage Office of the Secretary (OS) _______________________________________________________________________ 911. SHARED RISK EXCEPTION TO THE SAFE HARBOR PROVISIONS Priority: Substantive, Nonsignificant Legal Authority: 42 USC 1302; 42 USC 1320a-7b; 42 USC 1395hh; PL 104- 191, sec 216(b) CFR Citation: 42 CFR 1001 Legal Deadline: Final, Statutory, January 1, 1997. Abstract: This final rule establishes a new statutory exception for risk-sharing arrangements under the Federal health care programs' anti- kickback provisions. The rule sets forth an exception from liability for remuneration between an eligible organization and an individual or entity providing items or services in accordance with a written agreement between these parties. The rule allows remuneration between an organization and an individual or entity if a written agreement places the individual or entity at ``substantial financial risk'' for the cost or utilization of the items or services that the individual or entity is obligated to provide. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ ANPRM 05/23/97 62 FR 28410 ANPRM Comment Period End 06/09/97 Interim Final Rule 11/19/99 64 FR 63504 Final Action 04/00/05 Regulatory Flexibility Analysis Required: No Government Levels Affected: None Agency Contact: Joel Jay Schaer, Regulations Officer, Department of Health and Human Services, Office of the Secretary, Office of Inspector General (OIG), 330 Independence Avenue SW., Washington, DC 20201 Phone: 202 619-0089 Related RIN: Related to 0991-AB06 RIN: 0991-AA91 _______________________________________________________________________ 912. AMENDING THE REGULATIONS GOVERNING NONDISCRIMINATION ON THE BASIS OF RACE, COLOR, NATIONAL ORIGIN, HANDICAP, SEX, AND AGE TO CONFORM TO THE CIVIL RIGHTS RESTORATION ACT OF 1987 Priority: Other Significant. Major status under 5 USC 801 is undetermined. Legal Authority: PL 100-259, Civil Rights Restoration Act of 1987 CFR Citation: 45 CFR 80; 45 CFR 84; 45 CFR 86; 45 CFR 90; 45 CFR 91 Legal Deadline: None Abstract: The Secretary proposes to amend the Department's regulations implementing title VI of the Civil Rights Act of 1964, as amended, section 504 of the Rehabilitation Act of 1973, as amended, title IX of the Education Amendments of 1972, and the Age Discrimination Act of 1975, as amended. The principal proposed conforming change is to amend the regulations to add the definitions of ``program or activity'' or ``program'' that correspond to the statutory definitions enacted under the Civil Rights Restoration Act of 1987. [[Page 73130]] Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 12/06/00 65 FR 76460 Final Action 03/00/05 Regulatory Flexibility Analysis Required: No Small Entities Affected: Businesses, Governmental Jurisdictions, Organizations Government Levels Affected: Federal, Local, State, Tribal Agency Contact: Robinsue Frohboese, Principal Deputy Director, Office for Civil Rights, Department of Health and Human Services, Office of the Secretary, 200 Independence Avenue SW., Washington, DC 20202 Phone: 202 619-0403 RIN: 0991-AB10 _______________________________________________________________________ 913. SAFE HARBOR FOR WAIVER OF BENEFICIARY COINSURANCE AND DEDUCTIBLE AMOUNTS FOR A MEDICARE SELECT POLICY Priority: Substantive, Nonsignificant Legal Authority: PL 100-93, sec 14(a) CFR Citation: 42 CFR 1001 Legal Deadline: None Abstract: This final rule will expand the existing safe harbor for certain waivers of beneficiary coinsurance and deductible amounts to benefit the policyholders of Medicare SELECT supplemental insurance. Specifically, the amended safe harbor will protect waivers of coinsurance and deductible amounts under part A or part B of the Medicare program owed by beneficiaries covered by a Medicare SELECT policy issued in accordance with section 1882(t)(1) of the Social Security Act, if the waiver is in accordance with a price reduction agreement covering such policyholders between the Medicare SELECT issuer and the provider or supplier offering the waiver. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 09/25/02 67 FR 60202 NPRM Comment Period End 10/25/02 Final Action 04/00/05 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Joel Jay Schaer, Regulations Officer, Department of Health and Human Services, Office of the Secretary, Office of Inspector General (OIG), 330 Independence Avenue SW., Washington, DC 20201 Phone: 202 619-0089 RIN: 0991-AB16 _______________________________________________________________________ 914. CLARIFICATION OF TERMS AND APPLICATION OF PROGRAM EXCLUSION AUTHORITY FOR SUBMITTING CLAIMS CONTAINING EXCESSIVE CHARGES Priority: Substantive, Nonsignificant Legal Authority: Sec 112B (6) (6)(A) of the Social Security Act CFR Citation: 42 CFR 1001 Legal Deadline: None Abstract: This rule would amend the OIG exclusion regulations at 42 CFR 1001.701, addressing excessive claims, by including definitions for the terms ``substantially in excess'' and ``usual charges,'' and by clarifying the ``good cause'' exception set forth in this section. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 09/15/03 68 FR 53939 NPRM Comment Period End 11/14/03 Final Action 04/00/05 Regulatory Flexibility Analysis Required: No Government Levels Affected: None Agency Contact: Joel Jay Schaer, Regulations Officer, Department of Health and Human Services, Office of the Secretary, Office of Inspector General (OIG), 330 Independence Avenue SW., Washington, DC 20201 Phone: 202 619-0089 RIN: 0991-AB23 _______________________________________________________________________ Department of Health and Human Services (HHS) Long-Term Actions Office of the Secretary (OS) _______________________________________________________________________ 915. REVISIONS TO REGULATIONS ADDRESSING THE OIG'S AUTHORITY TO IMPOSE CIVIL MONEY PENALTIES AND ASSESSMENTS Priority: Substantive, Nonsignificant Legal Authority: 42 USC 1320a-7a; 42 USC 1395mm; 42 USC 1395w-27; 42 USC 1396b; 42 USC 1396u-2 CFR Citation: 42 CFR 1003 Legal Deadline: None Abstract: This proposed rule would revise part 1003, addressing the Office of Inspector General's authority to propose the imposition of civil money penalties and assessments, by reorganizing and simplifying existing regulatory text and eliminating obsolete references contained in the current regulations. Among the proposed revisions, this rule would establish separate subparts within part 1003 for various categories of violations; modify the current definition for the term ``claim;'' update various references to managed care organization authorities; and clarify the application of section 1140 of the Social Security Act with respect to the misuse of certain Departmental symbols, emblems, or names through Internet and e-mail communications. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM To Be Determined Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Joel Jay Schaer, Regulations Officer, Department of Health and Human Services, Office of the Secretary, Office of Inspector General (OIG), 330 Independence Avenue SW., Washington, DC 20201 Phone: 202 619-0089 RIN: 0991-AB03 [[Page 73131]] _______________________________________________________________________ 916. CLAIMS COLLECTION Priority: Substantive, Nonsignificant Legal Authority: 31 USC 3711; 31 CFR 900 to 904 CFR Citation: 45 CFR 30 Legal Deadline: None Abstract: The Department will amend part 30 of title 45 of the Code of Federal Regulations (CFR) to reflect the amendments to the Federal Claims Collection Act made by the Debt Collection Improvement Act of 1996 (DCIA), Public Law 104-134, 110 Stat. 1321 to 1358, as implemented by the Department of the Treasury at 31 CFR 900-904. The proposed rule will prescribe the standards and procedures for the Department's use in the administrative collection, offset, compromise, and suspension or termination of debts owed to the Department. The proposed rule is required in order to bring the Department's claims collection provisions in compliance with the Department of the Treasury regulations. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 07/13/04 69 FR 42010 Final Action To Be Determined Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Jefferey S. Davis, Associate General Counsel, Department of Health and Human Services, Office of the Secretary, Office of the General Counsel, Room 5362, HHS Cohen Building, 330 Independence Avenue SW., Washington, DC 20201 Phone: 202 619-0150 RIN: 0991-AB18 _______________________________________________________________________ 917. SALARY OFFSET Priority: Substantive, Nonsignificant Unfunded Mandates: Undetermined Legal Authority: 5 USC 5514; 5 CFR 550 CFR Citation: 45 CFR 33 Legal Deadline: None Abstract: The Department will add a new part 33 to title 45 of the Code of Federal Regulations (CFR) to implement the salary offset provisions of the Debt Collection Improvement Act of 1996 (DCIA), Public Law 104- 134, 110 Stat. 1321 to 1358, codified at 5 U.S.C. 5514, as implemented by the Office of Personnel Management at 5 CFR part 550, subpart K. The proposed rule is required in order to bring the Department's salary offset provisions in compliance with Governmentwide regulations published by the Office of Personnel Management. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 07/13/04 Final Action To Be Determined Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Jefferey S. Davis, Associate General Counsel, Department of Health and Human Services, Office of the Secretary, Office of the General Counsel, Room 5362, HHS Cohen Building, 330 Independence Avenue SW., Washington, DC 20201 Phone: 202 619-0150 RIN: 0991-AB19 _______________________________________________________________________ 918. MEDICARE AND FEDERAL HEALTH CARE PROGRAMS: FRAUD AND ABUSE; REVISIONS TO THE WAIVER PROVISIONS OF THE OIG'S EXCLUSION AUTHORITIES Priority: Substantive, Nonsignificant Legal Authority: Sec 949, PL 108-173; Sec 4331, PL 105-33; Sec 1128(c)(3)(b), Social Security Act CFR Citation: 42 CFR 1001 Legal Deadline: None Abstract: In accordance with section 949 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, this rule would revise the OIG's exclusion authority to permit any Federal healthcare program to request a waiver of an OIG exclusion imposed under sections 1128(a)(1), 1128(a)(3), or 1128(a)(4) of the Social Security Act. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM To Be Determined Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: Federal Agency Contact: Joel Jay Schaer, Regulations Officer, Department of Health and Human Services, Office of the Secretary, Office of Inspector General (OIG), 330 Independence Avenue SW., Washington, DC 20201 Phone: 202 619-0089 RIN: 0991-AB33 _______________________________________________________________________ Department of Health and Human Services (HHS) Completed Actions Office of the Secretary (OS) _______________________________________________________________________ 919. SAFE HARBOR FOR ARRANGEMENTS INVOLVING FEDERALLY QUALIFIED HEALTH CENTERS Priority: Substantive, Nonsignificant CFR Citation: 42 CFR 1001 Completed: ________________________________________________________________________ Reason Date FR Cite ________________________________________________________________________ Withdrawn - Superceded by 0991- AB37 09/07/04 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Joel Jay Schaer Phone: 202 619-0089 Related RIN: Related to 0991-AA91 RIN: 0991-AB06 _______________________________________________________________________ 920. TECHNICAL REVISIONS TO HIPDB DATA COLLECTION ACTIVITIES Priority: Substantive, Nonsignificant CFR Citation: 45 CFR 61 Completed: ________________________________________________________________________ Reason Date FR Cite ________________________________________________________________________ Interim Final Rule 06/17/04 69 FR 33866 [[Page 73132]] Interim Final Rule Comment Period End 07/19/04 Final Action 11/02/04 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Joel Jay Schaer Phone: 202 619-0089 RIN: 0991-AB31 _______________________________________________________________________ 921. PARTICIPATION IN DEPARTMENT OF HEALTH AND HUMAN SERVICES PROGRAMS BY RELIGIOUS ORGANIZATIONS; PROVIDING FOR EQUAL TREATMENT OF ALL DEPARTMENT OF HEALTH AND HUMAN SERVICES PROGRAM PARTICIPANTS Priority: Substantive, Nonsignificant Legal Authority: 5 USC 301 CFR Citation: 45 CFR 74 Legal Deadline: None Abstract: This rulemaking completes the Department's effort to implement executive branch policy that, within the framework of constitutional church-state guidelines, religiously affiliated (or ``faith-based'') organizations should be able to compete on an equal footing with other organizations for the Department's funding without impairing the religious character of such organizations. It revises Department regulations to remove barriers to the participation of faith-based organizations in Department programs, and to ensure that these programs are implemented in a manner consistent with applicable statutes and the requirements of the Constitution. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 03/09/04 69 FR 10991 Final Action 07/16/04 69 FR 42586 Regulatory Flexibility Analysis Required: No Government Levels Affected: None Agency Contact: Bobby Polito, Director, Center for Faith-Based and Community Initiatives, Department of Health and Human Services, Room 120F, 200 Independence Avenue NW., Washington, DC 20201 Phone: 202 358-3595 Related RIN: Previously reported as 0991-AB32 RIN: 0991-AB34 _______________________________________________________________________ Department of Health and Human Services (HHS) Proposed Rule Stage Substance Abuse and Mental Health Services Administration (SAMHSA) _______________________________________________________________________ 922. REQUIREMENTS GOVERNING THE USE OF SECLUSION AND RESTRAINT IN CERTAIN NONMEDICAL COMMUNITY-BASED FACILITIES FOR CHILDREN AND YOUTH Priority: Other Significant. Major status under 5 USC 801 is undetermined. Legal Authority: PL 106-310 CFR Citation: Not Yet Determined Legal Deadline: NPRM, Statutory, April 2001. Abstract: The Secretary is required by statute to publish regulations governing States that license nonmedical, community-based residential facilities for children and youth. The regulation requires States to develop licensing rules and monitoring requirements concerning behavior management practice that will ensure compliance; requires States to develop and implement such licensing rules and implementation requirements within one year; and ensures that States require such facilities to have adequate staff, and that the States provide training for professional staff. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 04/00/05 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: State Federalism: This action may have federalism implications as defined in EO 13132. Agency Contact: Paolo Del Vecchio, Department of Health and Human Services, Substance Abuse and Mental Health Services Administration, Room 13-103, Parklawn Building, 5600 Fishers Lane, Rockville, MD 20857 Phone: 301 443-2619 RIN: 0930-AA10 _______________________________________________________________________ Department of Health and Human Services (HHS) Final Rule Stage Substance Abuse and Mental Health Services Administration (SAMHSA) _______________________________________________________________________ 923. MANDATORY GUIDELINES FOR THE FEDERAL WORKPLACE DRUG TESTING PROGRAM Priority: Other Significant Legal Authority: PL 100-71; 5 USC 7301 CFR Citation: None Legal Deadline: NPRM, Statutory, December 2003. Abstract: HHS is proposing to establish scientific and technical guidelines for the testing of hair, sweat, and oral fluid specimens in addition to urine specimens; scientific and technical guidelines for using on-site tests to test urine and oral fluids at the collection site; requirements for the certification of instrumented initial test facilities; and added standards for collectors, on-site testers, and medical review officers. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Notice 04/13/04 69 FR 19673 Final Action 04/00/05 [[Page 73133]] Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: Federal Agency Contact: Joseph Denis Faha, Director, DLEA, SAMHSA, Department of Health and Human Services, Substance Abuse and Mental Health Services Administration, Room 12C-15, 5600 Fishers Lane, Rockville, MD 20857 Phone: 301 443-7017 Fax: 301 443-1450 Email: jfaha@samhsa.gov RIN: 0930-AA12 _______________________________________________________________________ Department of Health and Human Services (HHS) Proposed Rule Stage Centers for Disease Control and Prevention (CDC) _______________________________________________________________________ 924. AMENDMENTS TO QUALITY ASSURANCE AND ADMINISTRATIVE PROVISION FOR APPROVAL OF RESPIRATORY PROTECTIVE DEVICES Priority: Other Significant. Major status under 5 USC 801 is undetermined. Legal Authority: 29 USC 651 et seq; 30 USC 3; 30 USC 5; 30 USC 7; 30 USC 811; 30 USC 842(h); 30 USC 844 CFR Citation: 42 CFR 84 Legal Deadline: None Abstract: NIOSH plans to modify the Administrative/Quality Assurance sections of 42 CFR part 84, Approval of Respiratory Protective Devices. Areas for potential modification in this module are: 1) upgrade of quality assurance requirements; 2) ability to use private sector quality auditors and private sector testing laboratories in the approval program; 3) revised approval label requirements; 4) updated and restructured fee schedule; and 5) fee retention in the respirator program. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 02/00/05 Regulatory Flexibility Analysis Required: Undetermined Small Entities Affected: Businesses Government Levels Affected: None Agency Contact: Roland Berry Ann, Acting Chief, Respirator Branch, National Personal Protection Technology Laboratory, Department of Health and Human Services, Centers for Disease Control and Prevention, NIOSH, P.O. Box 18070, 626 Cochrans Mill Road, Pittsburgh, PA 15236 Phone: 412 386-4000 RIN: 0920-AA04 _______________________________________________________________________ Department of Health and Human Services (HHS) Final Rule Stage Centers for Disease Control and Prevention (CDC) _______________________________________________________________________ 925. POSSESSION, USE, AND TRANSFER OF SELECT AGENTS AND TOXINS Priority: Other Significant Legal Authority: PL 107-188 CFR Citation: 42 CFR 72; 42 CFR 72.6 Legal Deadline: None Abstract: Title II of subtitle B of Public Law 107-188, the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act), repeals, expands, and incorporates the Secretary's current authority to regulate the transfer of certain biological agents and toxins (select agents). The Bioterrorism Act specifies that the Secretary develop and biennially review a specified list of select agents. Safety procedures must be established and enforced for the possession, use, and transfer of the listed agents and toxins; access to select agents is limited to individuals and entities that pass background checks administered by the Attorney General. The Bioterrorism Act exempts certain information from disclosure under the Freedom of Information Act, including information that would identify the location of regulated entities or their security measures. Subtitle C of the Bioterrorism Act outlines the required interagency coordination between the Department of Health and Human Services and the Department of Agriculture regarding agents that are regulated by both departments (overlap agents). This action will bring to completion the Department's rulemaking in this area. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Final Action 01/00/05 Regulatory Flexibility Analysis Required: No Government Levels Affected: None Additional Information: Under RIN 0920-AA08, this regulation published as an interim final rule on December 13, 2002, at 67 FR 76886. An amended interim final rule with a request for comments was also published on November 3, 2003, at 68 FR 62245. Subsequently, RIN 0920- AA08 was inadvertently completed in the april 2003 Unified Agenda. Agency Contact: Mark Hemphill, Chief of Policy, Select Agent Program, Department of Health and Human Services, Centers for Disease Control and Prevention, 1600 Clifton Rd, MS E-79, Atlanta, GA 30333 Phone: 404 498-2255 Related RIN: Previously reported as 0920-AA08 RIN: 0920-AA09 [[Page 73134]] _______________________________________________________________________ Department of Health and Human Services (HHS) Prerule Stage Food and Drug Administration (FDA) _______________________________________________________________________ 926. FOOD LABELING; PROMINENCE OF CALORIES Regulatory Plan: This entry is Seq. No. 41 in part II of this issue of the Federal Register. RIN: 0910-AF22 _______________________________________________________________________ 927. FOOD LABELING; SERVING SIZES OF PRODUCTS THAT CAN REASONABLY BE CONSUMED AT ONE EATING OCCASION; UPDATING OF REFERENCE AMOUNTS CUSTOMARILY CONSUMED; APPROACHES FOR RECOMMENDING SMALLER PORTION SIZES Regulatory Plan: This entry is Seq. No. 42 in part II of this issue of the Federal Register. RIN: 0910-AF23 _______________________________________________________________________ 928. OVER-THE-COUNTER (OTC) DRUG REVIEW--SUNSCREEN PRODUCTS Priority: Routine and Frequent Legal Authority: 21 USC 321p; 21 USC 351 to 353; 21 USC 355; 21 USC 360a; 21 USC 371a; 21 USC 331; 21 USC 360; 21 USC 371 CFR Citation: 21 CFR 201; 21 CFR 310; 21 CFR 330 to 358 Legal Deadline: None Abstract: The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safe and effective and not misbranded. After a final monograph (i.e. final rule) is issued, only OTC drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. One action addresses formulation, labeling, and testing requirements for both ultraviolet B (UVB) and ultraviolet A (UVA) radiation protection, and the other action addresses combination products containing sunscreen and insect repellent ingredients. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ ANPRM (Sunscreen and Insect Repellent) 01/00/05 NPRM (UVA/UVB) 03/00/05 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: None Agency Contact: Gerald M. Rachanow, Regulatory Counsel, Division of Over-the-Counter Drug Products, Department of Health and Human Services, Food and Drug Administration, HFD-560, Center for Drug Evaluation and Research, 5600 Fishers Lane, HFD-560, Rockville, MD 20857 Phone: 301 827-2241 Fax: 301 827-2315 Email: rachanow@cder.fda.gov Related RIN: Split from 0910-AA01 RIN: 0910-AF43 _______________________________________________________________________ Department of Health and Human Services (HHS) Proposed Rule Stage Food and Drug Administration (FDA) _______________________________________________________________________ 929. FOREIGN AND DOMESTIC ESTABLISHMENT REGISTRATION AND LISTING REQUIREMENTS FOR HUMAN DRUGS, CERTAIN BIOLOGICAL DRUGS, AND ANIMAL DRUGS Regulatory Plan: This entry is Seq. No. 43 in part II of this issue of the Federal Register. RIN: 0910-AA49 _______________________________________________________________________ 930. MEDICAL DEVICES; ANESTHESIOLOGY DEVICES; PROPOSED RECLASSIFICATION OF PRESSURE REGULATORS FOR USE WITH MEDICAL OXYGEN Priority: Substantive, Nonsignificant Legal Authority: 21 USC 351; 21 USC 352; 21 USC 360c(e)(1); 21 USC 371 CFR Citation: 21 CFR 868.2700; 21 CFR 868.5905 Legal Deadline: None Abstract: The Food and Drug Administration (FDA) is proposing to reclassify pressure regulators for use with medical oxygen from class I to class II and to establish a special control for oxygen pressure regulators to address problems of fire and explosion associated with use of these devices. The special control will be a guidance document that includes standardized testing, performance, and labeling guidance for industry. Devices that meet the special control will be exempt from the premarket notification requirements of the Act. The agency believes it is taking a least burdensome approach for industry. This proposed rule will phase-in a compliance approach that will minimize the cost. FDA seeks to reclassify these devices under section 513(e)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360c(e)(1)). Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 12/00/04 Regulatory Flexibility Analysis Required: Undetermined Government Levels Affected: Undetermined Federalism: Undetermined Agency Contact: Joseph M. Sheehan, Chief, Regulations Staff, Department of Health and Human Services, Food and Drug Administration, HFZ-215, Center for Devices and Radiological Health, HFZ-215, 1350 Piccard Drive, Rockville, MD 20850 Phone: 301 827-2974 Fax: 301 594-4765 Email: joseph.sheehan@fda.hhs.gov RIN: 0910-AC30 _______________________________________________________________________ 931. SUBMISSION OF STANDARDIZED ELECTRONIC STUDY DATA FROM CLINICAL STUDIES EVALUATING HUMAN DRUGS AND BIOLOGICS Priority: Substantive, Nonsignificant. Major status under 5 USC 801 is undetermined. Legal Authority: 21 USC 355; 21 USC 371; 42 USC 262 CFR Citation: 21 CFR 314.50; 21 CFR 601.12; 21 CFR 314.94 Legal Deadline: None Abstract: The Food and Drug Administration (FDA) is proposing to amend the regulations governing the [[Page 73135]] format in which clinical study data (CSD) are required to be submitted for new drug applications (NDAs), biological license applications (BLAs), and abbreviated new drug applications (ANDAs). The proposal would revise our regulations to require that CSD submitted for NDAs, ANDAs, BLAs, and their supplements and amendments be provided in electronic format and require the use of standard data structure, terminology, and code sets. The proposal would improve the efficiency of the exchange of information from clinical studies through the adoption of standards for study data submitted in an electronic form that FDA can process, review, and archive. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 06/00/05 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: Undetermined Agency Contact: Nicole K. Mueller, Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, Room 3037, (HFD-7), Center for Drug Evaluation and Research, 5515 Security Lane, Suite 1101 (HFD-7), Rockville, MD 20852 Phone: 301 594-2041 Fax: 301 594-6197 Email: muellern@cder.fda.gov RIN: 0910-AC52 _______________________________________________________________________ 932. MEDICAL GAS CONTAINERS AND CLOSURES; CURRENT GOOD MANUFACTURING PRACTICE REQUIREMENTS Priority: Substantive, Nonsignificant. Major status under 5 USC 801 is undetermined. Legal Authority: 21 USC 321; 21 USC 351; 21 USC 353 CFR Citation: 21 CFR 201.161(a); 21 CFR 210.3(b); 21 CFR 211.94 Legal Deadline: None Abstract: The Food and Drug Administration is proposing to amend its current good manufacturing practice regulations and other regulations to clarify and strengthen requirements for the label, color, dedication, and design of medical gas containers and closures. Despite existing regulatory requirements and industry standards for medical gases, there have been repeated incidents in which cryogenic containers of harmful industrial gases have been connected to medical oxygen supply systems in hospitals and nursing homes, and subsequently administered to patients. These incidents have resulted in death and serious injury. There have also been several incidents involving high- pressure medical gas cylinders that have resulted in death and injuries to patients. These proposed amendments, together with existing regulations, are intended to ensure that the types of incidents that have occurred in the past, as well as other types of foreseeable and potentially deadly medical gas mixups, do not occur in the future. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 06/00/05 Regulatory Flexibility Analysis Required: Undetermined Government Levels Affected: None Agency Contact: Elaine H. Tseng, Office of Regulatory Policy, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, 5515 Security Lane, Suite 1101 (HFD-7), Rockville, MD 20852 Phone: 301 594-2041 Fax: 301 827-5562 RIN: 0910-AC53 _______________________________________________________________________ 933. FOOD STANDARDS: GENERAL PRINCIPLES AND FOOD STANDARDS MODERNIZATION Priority: Other Significant Legal Authority: 21 USC 321; 21 USC 336; 21 USC 341; 21 USC 343; 21 USC 371 CFR Citation: 21 CFR 130.5 Legal Deadline: None Abstract: In 1995, the FDA and FSIS reviewed their regulatory procedures and requirements for food standards to determine whether any were still needed, and if so, which ones should be modified or streamlined. To request public comment to assist them in their review of the need for food standards, both agencies published advance notices of proposed rulemaking (ANPRMs) on food standards in December, 1995 (60 FR 47453 and 60 FR 67492). These ANPRMs discussed the agencies' regulations and policy governing food standards, the history of food standards, and the possible need to revise the food standards. Several comments in response to the ANPRMs recommended that the agencies establish general principles or a fundamental philosophy for reviewing food standards and revising them. The agencies agreed with these comments and determined that it would be appropriate to develop general principles for reviewing and revising food standards regulations. The agencies also agreed with the comments that stated that the agencies should work in concert to develop consistent food standards regulations. FDA and FSIS are now proposing a set of general principles that define how modern food standards should be structured. If this proposed rule is adopted, FDA and FSIS will require that a citizen petition for establishing, revising, or eliminating a food standard in 21 CFR parts 130 to 169 and 7 CFR part 410 be submitted in accordance with the general principles. Conversely, the agencies may find deficient a petition to establish, revise, or eliminate a food standard that does not follow these general principles. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ ANPRM 12/29/95 60 FR 67492 ANPRM Comment Period End 04/29/96 NPRM 12/00/04 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: Undetermined Agency Contact: Ritu Nalubola, Staff Fellow, Department of Health and Human Services, Food and Drug Administration, HFS-820, Center for Food Safety and Applied Nutrition, Harvey Wiley Building, 5100 Paint Branch Parkway, College Park, MD 20740 Phone: 301 436-2371 Fax: 301 436-2636 Email: ritu.nalubola@cfsan.fda.gov Related RIN: Related to 0583-AC72 RIN: 0910-AC54 [[Page 73136]] _______________________________________________________________________ 934. POSITRON EMISSION TOMOGRAPHY DRUGS; CURRENT GOOD MANUFACTURING PRACTICES Priority: Other Significant. Major status under 5 USC 801 is undetermined. Unfunded Mandates: Undetermined Legal Authority: PL 105-115, sec 121 CFR Citation: 21 CFR 212 Legal Deadline: Final, Statutory, November 21, 1999. Abstract: Section 121 of the Food and Drug Administration Modernization Act of 1997 (Pub. L. 105-115) directs FDA to establish requirements for current good manufacturing practices (CGMPs) for positron emission tomography (PET) drugs, a type of radiopharmaceutical. The proposed rule would adopt CGMPs that reflect the unique characteristics of PET drugs. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 01/00/05 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Governmental Jurisdictions Government Levels Affected: Federal, State URL For More Information: www.fda.gov/cder/regulatory/pet Agency Contact: Wayne H. Mitchell, Regulatory Counsel, Office of Regulatory Policy, Department of Health and Human Services, Food and Drug Administration, Suite 3037 (HFD-7), Center for Drug Evaluation and Research, 5515 Security Lane, Suite 1101 (HFD-7), Rockville, MD 20852 Phone: 301 594-2041 Fax: 301 827-5562 Email: mitchellw@cder.fda.gov Related RIN: Previously reported as 0910-AB63 RIN: 0910-AC55 _______________________________________________________________________ 935. REPORTING INFORMATION REGARDING FALSIFICATION OF DATA Priority: Other Significant. Major status under 5 USC 801 is undetermined. Unfunded Mandates: Undetermined Legal Authority: 21 USC 321; 21 USC 341 to 343; 21 USC 348; 21 USC 349; 21 USC 351; 21 USC 352; 21 USC 355; 21 USC 360b; 21 USC 360c; 21 USC 360e; 21 USC 360i to 360k; 21 USC 361; 21 USC 371; 21 USC 379e; 42 USC 262 CFR Citation: 21 CFR 58.11; 21 CFR 71.1; 21 CFR 101.69; 21 CFR 101.70; 21 CFR 171.1; 21 CFR 190.6; 21 CFR 312.3; 21 CFR 312.56; 21 CFR 511.1; 21 CFR 812.46 Legal Deadline: None Abstract: The proposed rule would require sponsors to promptly report any information indicating that any person has or may have engaged in the falsification of data in the course of proposing, designing, performing, recording, supervising, or reviewing research, or in reporting research results. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 05/00/05 Regulatory Flexibility Analysis Required: Undetermined Government Levels Affected: None Agency Contact: Brian L. Pendleton, Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, Suite 3037 (HFD-7), Center for Drug Evaluation and Research, 5515 Security Lane, Suite 1101 (HFD-7), Rockville, MD 20852 Phone: 301 594-2041 Fax: 301 827-5562 Email: pendletonb@cder.fda.gov Related RIN: Previously reported as 0910-AC02 RIN: 0910-AC59 _______________________________________________________________________ 936. HEALTH CLAIMS Priority: Other Significant Unfunded Mandates: Undetermined Legal Authority: 21 USC 343; 21 USC 371 CFR Citation: Not Yet Determined Legal Deadline: None Abstract: On November 25, 2003 (68 FR 66040), FDA issued an advance notice of proposed rulemaking (ANPRM) to request comments on alternatives for regulating qualified health claims in the labeling of conventional human foods and dietary supplements. FDA also solicited comments on various other issues related to health claims and on the appropriateness and nature of dietary guidance statements on conventional food and dietary supplement labels. This ANPRM was signaled in the July 11, 2003 (68 FR 41387) notice that announced the availability of the final report of the FDA Task Force on the Consumer Health Information for Better Nutrition Initiative. Comments on the regulatory alternatives and additional topics identified in the ANPRM will inform FDA decisions about regulation of qualified health claims. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ ANPRM 11/25/03 68 FR 66040 ANPRM Comment Period Extended 01/27/04 69 FR 3868 ANPRM Comment Period End 02/25/04 NPRM 07/00/05 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: None Federalism: Undetermined Agency Contact: Nancy Crane, Department of Health and Human Services, Food and Drug Administration, HFS-830, 5100 Paint Branch Parkway, College Park, MD 20740 Phone: 301 436-1456 Fax: 301 436-2636 Email: nancy.crane@cfsan.fda.gov RIN: 0910-AF09 _______________________________________________________________________ 937. QUALITY STANDARD REGULATION ESTABLISHING AN ALLOWABLE LEVEL FOR ARSENIC IN BOTTLED WATER Priority: Other Significant. Major status under 5 USC 801 is undetermined. Legal Authority: 21 USC 321; 21 USC 341; 21 USC 343; 21 USC 343-1; 21 USC 348; 21 USC 349; 21 USC 371; 21 USC 379e CFR Citation: 21 CFR 165.110(b) Legal Deadline: Final, Statutory, July 27, 2005. Abstract: Under section 410 of the Federal Food, Drug, and Cosmetic Act (the Act), not later than 180 days before the effective date of a National Primary Drinking Water Regulation (NPDWR) issued by the Environmental Protection Agency (EPA) for a contaminant under [[Page 73137]] section 1412 of the Safe Drinking Water Act, the Food and Drug Administration (FDA) is required to issue a standard of quality regulation for that contaminant in bottled water or make a finding that such a regulation is not necessary to protect the public health because the contaminant is contained in water in public water systems but not in water used for bottled water. The effective date for any such standard of quality regulation is to be the same as the effective date of the NPDWR. On January 22, 2001, EPA published a final rule revising the existing 0.05 mg/L maximum contaminant level (MCL) for arsenic in public drinking water to 0.01 mg/L (10 ppb). The effective date for this rule was temporarily delayed for 60 days from March 23, 2001, to a new effective date of May 22, 2001, in accordance with the memorandum of January 20, 2001, from the Assistant to the President and Chief of Staff, entitled ``Regulatory Review Plan'' (66 FR 7701; January 24, 2001). On May 22, 2001, EPA announced that it would further delay the effective date for the rule until February 22, 2002, to allow time to complete a reassessment of the information on which the revised arsenic standard is based. On February 22, 2002, the arsenic MCL of 0.01 mg/L in public drinking water rule became effective and water systems must comply with the new standard for arsenic in public drinking water by January 23, 2006. On March 25, 2003 (68 FR 14501 at 14503), EPA revised the rule text in its January 2001 final rule that established the 10 parts per billion arsenic drinking water standard to express the standard as 0.010 mg/L, in order to clarify the implementation of the original rule. In accordance with section 410 of the Act, FDA is required to issue a standard of quality regulation for arsenic in bottled drinking water by July 27, 2005, with an effective date of January 23, 2006, or make a finding that such a regulation is not necessary to protect the public health. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 12/02/04 69 FR 70082 NPRM Comment Period End 01/31/05 Final Rule 06/00/05 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: Undetermined Federalism: Undetermined Agency Contact: Henry Kim, Supervisory Interdisciplinary Scientist, Department of Health and Human Services, Food and Drug Administration, HFS-306, 5100 Paint Branch Parkway, College Park, MD 20740 Phone: 301 436-2023 Fax: 301 436-2651 Email: hkim@cfsan.fda.gov RIN: 0910-AF10 _______________________________________________________________________ 938. CONTENT AND FORMAT OF LABELING FOR HUMAN PRESCRIPTION DRUGS AND BIOLOGICS; REQUIREMENTS FOR PREGNANCY AND LACTATION Priority: Substantive, Nonsignificant. Major status under 5 USC 801 is undetermined. Unfunded Mandates: Undetermined Legal Authority: 21 USC 321; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 358; 21 USC 360; 21 USC 360(b); 21 USC 360gg to 360ss; 21 USC 371; 21 USC 374; 21 USC 379e; 42 USC 216; 42 USC 241; 42 USC 262; 42 USC 264 CFR Citation: 21 CFR 201.57 Legal Deadline: None Abstract: The proposed rule would amend FDA regulations concerning the format and content of the ``Pregnancy,'' ``Labor and Delivery,'' and ``Nursing Mothers'' subsections of the ``Use in Specific Populations'' section of the labeling for human prescription drugs. The proposal would require that labeling include a summary of the risks of using a drug during pregnancy and lactation and a discussion of the data supporting that summary. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 06/00/05 Regulatory Flexibility Analysis Required: Undetermined Small Entities Affected: Businesses Government Levels Affected: Undetermined Federalism: Undetermined Agency Contact: Christine F. Rogers, Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, Suite 3059 (HFD-7), Center for Drug Evaulation and Research, 5515 Security Lane, Suite 1101 (HFD-7), Rockville, MD 20852 Phone: 301 594-2041 Fax: 301 827-5562 RIN: 0910-AF11 _______________________________________________________________________ 939. COCHINEAL EXTRACT AND CARMINE LABEL DECLARATION Priority: Other Significant. Major status under 5 USC 801 is undetermined. Legal Authority: 21 USC 379e(b) CFR Citation: 21 CFR 73.100(d); 21 CFR 73.1100(c); 21 CFR 73.2087(c); 21 CFR 101.22(k); 21 CFR 201.100(b); 21 CFR 201.324 Legal Deadline: None Abstract: The purpose of this proposed rule is to protect consumers who have allergies to the color additives carmine and cochineal extract by requiring label declaration on products under FDA jurisdiction. This action responds to adverse event reports received by FDA and to a citizen petition submitted to FDA. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 09/00/05 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: None Agency Contact: Mical E Honigfort, Consumer Safety Officer, Department of Health and Human Services, Food and Drug Administration, HFS-265, 5100 Paint Branch Parkway, College Park, MD 20740 Phone: 202 418-0714 Fax: 202-418-3126 Email: mhonigfo@cfsan.fda.gov RIN: 0910-AF12 _______________________________________________________________________ 940. CHARGING FOR INVESTIGATIONAL DRUGS Priority: Substantive, Nonsignificant. Major status under 5 USC 801 is undetermined. Legal Authority: 21 USC 321; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 371; 42 USC 262 CFR Citation: 21 CFR 312.7; 21 CFR 312.8 Legal Deadline: None [[Page 73138]] Abstract: The proposed rule would amend FDA's investigational new drug exemption regulations concerning charging for investigational drugs. The proposed rule describes the types of investigational uses for which a sponsor may be able to charge, including uses for which charging was not previously expressly permitted, and the criteria for allowing charging for the identified investigational uses. The proposed rule would also describe the types of costs that can be recovered when charging for an investigational drug. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 05/00/05 Regulatory Flexibility Analysis Required: Undetermined Small Entities Affected: Businesses Government Levels Affected: Undetermined Agency Contact: Christine F. Rogers, Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, Suite 3059 (HFD-7), Center for Drug Evaulation and Research, 5515 Security Lane, Suite 1101 (HFD-7), Rockville, MD 20852 Phone: 301 594-2041 Fax: 301 827-5562 RIN: 0910-AF13 _______________________________________________________________________ 941. TREATMENT USE OF INVESTIGATIONAL DRUGS Priority: Substantive, Nonsignificant. Major status under 5 USC 801 is undetermined. Legal Authority: 21 USC 321; 21 USC 331; 21 USC 351 to 353; 21 USC 353; 21 USC 355; 21 USC 371; 42 USC 262 CFR Citation: 21 CFR 312.42; 21 CFR 312.400; 21 CFR 312.405; 21 CFR 312.410; 21 CFR 312.415; 21 CFR 312.420; 21 CFR 312.425; 21 CFR 312.430; 21 CFR 312.435 Legal Deadline: None Abstract: The proposed rule would amend FDA regulations governing investigational new drugs (INDs) to describe the way patients may obtain investigational drugs for treatment use. Treatment use of investigational drugs would be available to: 1) individual patients, including in emergencies; 2) intermediate size patient populations; and 3) larger populations under a treatment protocol or IND. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 03/00/05 Regulatory Flexibility Analysis Required: Undetermined Small Entities Affected: Businesses Government Levels Affected: Undetermined Agency Contact: Christine F. Rogers, Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, Suite 3059 (HFD-7), Center for Drug Evaulation and Research, 5515 Security Lane, Suite 1101 (HFD-7), Rockville, MD 20852 Phone: 301 594-2041 Fax: 301 827-5562 RIN: 0910-AF14 _______________________________________________________________________ 942. DISTRIBUTION OF BLOOD DERIVATIVES BY REGISTERED BLOOD ESTABLISHMENTS THAT QUALIFY AS HEALTH CARE ENTITIES; PDMA OF 1987; PDA OF 1992; POLICIES, REQUIREMENTS, AND ADMINISTRATIVE PROCEDURES Priority: Substantive, Nonsignificant Legal Authority: 21 USC 351 to 353; 21 USC 371; 21 USC 374 CFR Citation: 21 CFR 203.3(q); 21 CFR 203.22(h); 21 CFR 205.3(h) Legal Deadline: None Abstract: FDA is proposing to amend certain limited provisions of the implementing regulations of the Prescription Drug Marketing Act (PDMA) of 1987, as modified by the Prescription Drug Amendments (PDA) of 1992 and the FDA Modernization Act of 1997. Certain provisions of that final rule that published on December 3, 1999, (64 FR 67720), do not allow a registered blood establishment that provides health care services related to its activities as a blood establishment to concurrently distribute blood derivatives. The effective date of those provisions of that rule is December 1, 2006, as published on February 23, 2004, (69 FR 8105). FDA is amending the final rule to allow a registered blood establishment that concurrently provides health care services to also distribute blood derivatives. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 06/00/05 Regulatory Flexibility Analysis Required: No Government Levels Affected: None Additional Information: Delayed effective date of portion of rule to 12/01/06, effective date of non-stayed portion of final rule, 64 FR 67720, December 3, 1999 Agency Contact: Kathleen E. Swisher, Supervisory Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research, 1401 Rockville Pike Suite 200N, Rockville, MD 20852 Phone: 301 827-6210 Fax: 301 827-9434 RIN: 0910-AF16 _______________________________________________________________________ 943. REVOCATION OF THE STATUS OF SPECIFIC PRODUCTS; GROUP A STREPTOCOCCUS Priority: Info./Admin./Other Legal Authority: 42 USC 262 CFR Citation: 21 CFR 610.19 Legal Deadline: None Abstract: FDA is issuing a direct final rule and companion proposed rule to revoke 21 CFR 610.19, Status of specific products; Group A streptococcus. The current regulation was based on the panel report for bacterial vaccines with ``No U.S. Standard of Potency.'' The vaccines had been licensed by the National Institutes of Health prior to 1972, when regulatory authority over these vaccines was transferred to FDA. The regulation prohibits the use of Group A streptococcus organisms and derivatives of Group A streptococcus as ingredients in Bacterial Vaccines and Bacterial Antigens with ``No U.S. Standard of Potency.'' The regulation was never intended to refer to purified streptococcus vaccines, which were not developed at that time. Therefore, the regulation is being revoked. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM - Companion to Direct Final Rule 05/00/05 Direct Final Rule 05/00/05 [[Page 73139]] Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Valerie Butler, Consumer Safety Officer, Department of Health and Human Services, Food and Drug Administration, Suite 200N (HFM-17), HFM-17, 1401 Rockville Pike, Rockville, MD 20852 Phone: 301 827-6210 Fax: 301 827-9434 RIN: 0910-AF20 _______________________________________________________________________ 944. OBSTETRICAL AND GYNECOLOGICAL DEVICES; DESIGNATION OF SPECIAL CONTROL FOR CONDOMS AND CONDOMS WITH SPERMICIDAL LUBRICANT Priority: Other Significant. Major status under 5 USC 801 is undetermined. Legal Authority: 21 USC 360c CFR Citation: 21 CFR 884.5300; 21 CFR 884.5310 Legal Deadline: None Abstract: The classification regulations for male condoms would be amended to specify a labeling guidance document as a special control for condoms made from NR latex. The new special control guidance document would identify issues requiring special controls and provide detailed recommendations for labeling to address these issues that together with the general controls, provides a reasonable assurance of the safety and effectiveness of these devices. These labeling recommendations are also consistent with the labeling requirements of 21 CFR 801. The rule will demonstrate how the agency is moving forward to meet the congressional directive of Public Law 106-554 that FDA review condom labeling to assure that the information regarding the overall effectiveness or lack of effectiveness of condoms in preventing sexually transmitted diseases is medically accurate. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 12/00/04 Regulatory Flexibility Analysis Required: Undetermined Small Entities Affected: Businesses Government Levels Affected: None Federalism: Undetermined Agency Contact: Joseph M. Sheehan, Chief, Regulations Staff, Department of Health and Human Services, Food and Drug Administration, HFZ-215, Center for Devices and Radiological Health, HFZ-215, 1350 Piccard Drive, Rockville, MD 20850 Phone: 301 827-2974 Fax: 301 594-4765 Email: joseph.sheehan@fda.hhs.gov RIN: 0910-AF21 _______________________________________________________________________ 945. BLOOD INITIATIVE--REQUIREMENTS FOR HUMAN BLOOD AND BLOOD COMPONENTS INTENDED FOR TRANSFUSION OR FOR FURTHER MANUFACTURING USE Priority: Other Significant Legal Authority: 21 USC 321; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 360; 21 USC 360c to 360e; 21 USC 360h to 360j; 21 USC 360l; 21 USC 371 ; 21 USC 372; 21 USC 374; 21 USC 381; 21 USC 383; 21 USC 372; 42 USC 216; 42 USC 243; 42 USC 262; 42 USC 263; 42 USC 263a; 42 USC 264; 42 USC 271 CFR Citation: 21 CFR 600; 21 CFR 601; 21 CFR 606; 21 CFR 607; 21 CFR 610; 21 CFR 630; 21 CFR 640; 21 CFR 660; 21 CFR 820; 21 CFR 1270 Legal Deadline: None Abstract: The Food and Drug Administration (FDA) is proposing to amend the biologics regulations by removing, revising, or updating specific regulations applicable to blood, blood components, Source Plasma, and Source Leukocytes to be more consistent with current practices and to remove unnecessary or outdated requirements. This action is based on FDA's comprehensive review of the biologics regulations. It is also based on reports by the U.S. House of Representatives Committee on Government Reform and Oversight Subcommittee on House Resources and Intergovernmental Relations, the General Accounting Office, and the Institute of Medicine, as well as on public comments. These actions are intended to help ensure the continued safety of the Nation's blood supply. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 09/00/05 Regulatory Flexibility Analysis Required: No Small Entities Affected: Businesses Government Levels Affected: None Agency Contact: Paula S. McKeever, Regulatory Policy Analyst, Department of Health and Human Services, Food and Drug Administration, Suite 200N (HFM-17), Center for Biologics Evaluation and Research, 1401 Rockville Pike, Rockville, MD 20852-1448 Phone: 301 827-6210 Fax: 301 827-9434 Related RIN: Split from 0910-AB26 RIN: 0910-AF25 _______________________________________________________________________ 946. OVER-THE-COUNTER (OTC) DRUG REVIEW--COUGH/COLD (BRONCHODILATOR) PRODUCTS Priority: Routine and Frequent Legal Authority: 21 USC 321p; 21 USC 351 to 353; 21 USC 355; 21 USC 360a; 21USC 371a; 21 USC 331; 21 USC 360; 21 USC 371 CFR Citation: 21 CFR 201; 21 CFR 310; 21 CFR 330 to 358 Legal Deadline: None Abstract: The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safe and effective and not misbranded. After a final monograph (i.e. final rule) is issued, only OTC drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. This action addresses labeling for these products. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM (Amendment) 12/00/04 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: None Agency Contact: Gerald M. Rachanow, Regulatory Counsel, Division of Over-the-Counter Drug Products, Department of Health and Human Services, Food and Drug Administration, HFD-560, Center for Drug Evaluation and Research, 5600 Fishers Lane, HFD-560, Rockville, MD 20857 Phone: 301 827-2241 Fax: 301 827-2315 Email: rachanow@cder.fda.gov Related RIN: Split from 0910-AA01 RIN: 0910-AF32 [[Page 73140]] _______________________________________________________________________ 947. OVER-THE-COUNTER (OTC) DRUG REVIEW--COUGH/COLD (COMBINATION) PRODUCTS Priority: Routine and Frequent Legal Authority: 21 USC 321p; 21 USC 351 to 353; 21 USC 355; 21 USC 360a; 21USC 371a; 21 USC 331; 21 USC 360; 21 USC 371 CFR Citation: 21 CFR 201; 21 CFR 310; 21 CFR 330 to 358 Legal Deadline: None Abstract: The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safe and effective and not misbranded. After a final monograph (i.e. final rule) is issued, only OTC drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. This action addresses combination products containing an oral bronchodilator. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM (Amendment) 12/00/04 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: None Agency Contact: Gerald M. Rachanow, Regulatory Counsel, Division of Over-the-Counter Drug Products, Department of Health and Human Services, Food and Drug Administration, HFD-560, Center for Drug Evaluation and Research, 5600 Fishers Lane, HFD-560, Rockville, MD 20857 Phone: 301 827-2241 Fax: 301 827-2315 Email: rachanow@cder.fda.gov Related RIN: Split from 0910-AA01 RIN: 0910-AF33 _______________________________________________________________________ 948. OVER-THE-COUNTER (OTC) DRUG REVIEW--COUGH/COLD (NASAL DECONGESTANT) PRODUCTS Priority: Routine and Frequent Legal Authority: 21 USC 321p; 21 USC 351 to 353; 21 USC 355; 21 USC 360a; 21 USC 371a; 21 USC 331; 21 USC 360; 21 USC 371 CFR Citation: 21 CFR 201; 21 CFR 310; 21 CFR 330 to 358 Legal Deadline: None Abstract: The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safe and effective and not misbranded. After a final monograph (i.e. final rule) is issued, only OTC drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. One action addresses the ingredient phenylephrine bitartrate, and the other action addresses the ingredient phenylpropanolamine. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM (Amendment) (Sinusitis Claim) 08/02/04 69 FR 46119 NPRM (Phenylephrine Bitartrate) 11/02/04 69 FR 63482 NPRM (Phenyl propanolamine) 12/00/04 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: None Agency Contact: Gerald M. Rachanow, Regulatory Counsel, Division of Over-the-Counter Drug Products, Department of Health and Human Services, Food and Drug Administration, HFD-560, Center for Drug Evaluation and Research, 5600 Fishers Lane, HFD-560, Rockville, MD 20857 Phone: 301 827-2241 Fax: 301 827-2315 Email: rachanow@cder.fda.gov Related RIN: Split from 0910-AA01 RIN: 0910-AF34 _______________________________________________________________________ 949. OVER-THE-COUNTER (OTC) DRUG REVIEW--INTERNAL ANALGESIC PRODUCTS Priority: Routine and Frequent Legal Authority: 21 USC 321p; 21 USC 351 to 353; 21 USC 355; 21 USC 360a; 21USC 371a; 21 USC 331; 21 USC 360; 21 USC 360gg to 360ss; 21 USC 371; 21 USC 374; 21 USC 379e; 42 USC 216; 42 USC 241; 42 USC 262; 42 USC 264 CFR Citation: 21 CFR 201; 21 CFR 310; 21 CFR 330 to 358 Legal Deadline: None Abstract: The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safe and effective and not misbranded. After a final monograph (i.e. final rule) is issued, only OTC drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. One action addresses labeling intended to better inform consumers of potential risks associated with these products. The second action addresses products marketed for children under two years old and weight- and age- based dosing for children's products. The third action addresses combination products containing the analgesic acetaminophen or aspirin and sodium bicarbonate used as an antacid ingredient. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM (Amendment) (Labeling) 12/00/04 NPRM (Amendment) (Pediatric) 02/00/05 NPRM (Amendment) (Combinations with Sodium Bicarbonate) 06/00/05 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: None Agency Contact: Gerald M. Rachanow, Regulatory Counsel, Division of Over-the-Counter Drug Products, Department of Health and Human Services, Food and Drug Administration, HFD-560, Center for Drug Evaluation and Research, 5600 Fishers Lane, HFD-560, Rockville, MD 20857 Phone: 301 827-2241 Fax: 301 827-2315 Email: rachanow@cder.fda.gov Related RIN: Split from 0910-AA01 RIN: 0910-AF36 _______________________________________________________________________ 950. OVER-THE-COUNTER (OTC) DRUG REVIEW--LABELING OF DRUG PRODUCTS FOR OTC HUMAN USE Priority: Routine and Frequent Legal Authority: 21 USC 321p; 21 USC 351 to 353; 21 USC 355; 21 USC 360a; 21USC 371a; 21 USC 331; 21 USC 360; 21 USC 371; 21 USC 358; 21 USC 360gg to 360ss; 21 USC 374; 21 USC 379e; 42 USC 216; 42 USC 241; 42 USC 262; 42 USC 264 CFR Citation: 21 CFR 201; 21 CFR 310; 21 CFR 330 to 358 Legal Deadline: None [[Page 73141]] Abstract: The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safe and effective and not misbranded. After a final monograph (i.e. final rule) is issued, only OTC drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. This action addresses labeling for convenience (small) size OTC drug packages. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM (Convenience Sizes) 02/00/05 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: None Agency Contact: Gerald M. Rachanow, Regulatory Counsel, Division of Over-the-Counter Drug Products, Department of Health and Human Services, Food and Drug Administration, HFD-560, Center for Drug Evaluation and Research, 5600 Fishers Lane, HFD-560, Rockville, MD 20857 Phone: 301 827-2241 Fax: 301 827-2315 Email: rachanow@cder.fda.gov Related RIN: Split from 0910-AA01 RIN: 0910-AF37 _______________________________________________________________________ 951. OVER-THE-COUNTER (OTC) DRUG REVIEW--WEIGHT CONTROL PRODUCTS Priority: Routine and Frequent Legal Authority: 21 USC 321p; 21 USC 351 to 353; 21 USC 355; 21 USC 360a; 21 USC 371a; 21 USC 331; 21 USC 360; 21 USC 371 CFR Citation: 21 CFR 201; 21 CFR 310; 21 CFR 330 to 358 Legal Deadline: None Abstract: The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safe and effective and not misbranded. After a final monograph (i.e. final rule) is issued, only OTC drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. One action addresses the ingredient phenylpropanolamine, and the other action addresses the ingredient benzocaine. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM (Phenyl propanolamine) 12/00/04 NPRM (Benzocaine) 06/00/05 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: None Agency Contact: Gerald M. Rachanow, Regulatory Counsel, Division of Over-the-Counter Drug Products, Department of Health and Human Services, Food and Drug Administration, HFD-560, Center for Drug Evaluation and Research, 5600 Fishers Lane, HFD-560, Rockville, MD 20857 Phone: 301 827-2241 Fax: 301 827-2315 Email: rachanow@cder.fda.gov Related RIN: Split from 0910-AA01 RIN: 0910-AF45 _______________________________________________________________________ 952. SUBSTANCES PROHIBITED FROM USE IN ANIMAL FOOD OR FEED Regulatory Plan: This entry is Seq. No. 44 in part II of this issue of the Federal Register. RIN: 0910-AF46 _______________________________________________________________________ 953. OVER-THE-COUNTER (OTC) DRUG REVIEW--DANDRUFF, SEBORRHEIC DERMATITIS, AND PSORIASIS PRODUCTS Priority: Routine and Frequent Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 360; 21 USC 360a; 21 USC 371; 21 USC 371a CFR Citation: 21 CFR 201; 21 CFR 310; 21 CFR 330 to 358 Legal Deadline: None Abstract: The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safe and effective and not misbranded. After a final monograph (i.e. final rule) is issued, only OTC drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. This action addresses combinations containing coal tar solution and menthol in a shampoo product. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM (Amendment) 02/00/05 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: None Agency Contact: Gerald M. Rachanow, Regulatory Counsel, Division of Over-the-Counter Drug Products, Department of Health and Human Services, Food and Drug Administration, HFD-560, Center for Drug Evaluation and Research, 5600 Fishers Lane, HFD-560, Rockville, MD 20857 Phone: 301 827-2241 Fax: 301 827-2315 Email: rachanow@cder.fda.gov RIN: 0910-AF49 _______________________________________________________________________ 954. OVER-THE-COUNTER (OTC) DRUG REVIEW-- OVERINDULGENCE IN FOOD AND DRINK PRODUCTS Priority: Routine and Frequent Legal Authority: 21 USC 321p; 21 USC 351 to 353; 21 USC 355; 21 USC 360; 21 USC 360a; 21 USC 371; 21 USC 371a; 21 USC 331 CFR Citation: 21 CFR 201; 21 CFR 310; 21 CFR 330 to 358 Legal Deadline: None Abstract: The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safe and effective and not misbranded. After a final monograph (i.e. final rule) is issued, only OTC drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. This action addresses products containing bismuth subsalicylate for relief of symptoms of upset stomach due to overindulgence resulting from food and drink. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM (Amendment) 02/00/05 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: None Agency Contact: Gerald M. Rachanow, Regulatory Counsel, Division of Over-the-Counter Drug Products, [[Page 73142]] Department of Health and Human Services, Food and Drug Administration, HFD-560, Center for Drug Evaluation and Research, 5600 Fishers Lane, HFD-560, Rockville, MD 20857 Phone: 301 827-2241 Fax: 301 827-2315 Email: rachanow@cder.fda.gov RIN: 0910-AF51 _______________________________________________________________________ 955. OVER-THE-COUNTER (OTC) DRUG REVIEW--SKIN BLEACHING PRODCUTS Priority: Routine and Frequent Legal Authority: 21 USC 321p; 21 USC 351 to 353; 21 USC 355; 21 USC 360; 21 USC 360a; 21 USC 371; 21 USC 371a; 21 USC 331 CFR Citation: 21 CFR 201; 21 CFR 310; 21 CFR 330 to 358 Legal Deadline: None Abstract: The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safe and effective and not misbranded. After a final monograph (i.e. final rule) is issued, only OTC drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. This action addresses products containing hydroquinone. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 06/00/05 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: None Agency Contact: Gerald M. Rachanow, Regulatory Counsel, Division of Over-the-Counter Drug Products, Department of Health and Human Services, Food and Drug Administration, HFD-560, Center for Drug Evaluation and Research, 5600 Fishers Lane, HFD-560, Rockville, MD 20857 Phone: 301 827-2241 Fax: 301 827-2315 Email: rachanow@cder.fda.gov RIN: 0910-AF53 _______________________________________________________________________ 956. USE OF MATERIALS DERIVED FROM CATTLE IN HUMAN AND ANIMAL MEDICAL PRODUCTS Regulatory Plan: This entry is Seq. No. 45 in part II of this issue of the Federal Register. RIN: 0910-AF54 _______________________________________________________________________ 957. REQUIREMENTS FOR HUMAN AND ANIMAL MEDICAL PRODUCTS MANUFACTURED FROM, PROCESSED WITH, OR OTHERWISE CONTAINING MATERIAL FROM CATTLE Regulatory Plan: This entry is Seq. No. 46 in part II of this issue of the Federal Register. RIN: 0910-AF55 _______________________________________________________________________ Department of Health and Human Services (HHS) Final Rule Stage Food and Drug Administration (FDA) _______________________________________________________________________ 958. INVESTIGATIONAL NEW DRUGS: EXPORT REQUIREMENTS FOR UNAPPROVED NEW DRUG PRODUCTS Priority: Routine and Frequent Legal Authority: 21 USC 321; 21 USC 381; 21 USC 382; 21 USC 393; 42 USC 241; 42 USC 243; 42 USC 262; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 371 CFR Citation: 21 CFR 312.110 Legal Deadline: None Abstract: The final rule would amend the regulations on the exportation of unapproved new drug products, including biological products, for investigational use. In general, the rule would provide four different routes for exporting an unapproved new drug product for investigational use. One route would permit exportation, if the drug is the subject of an investigational new drug application (IND) and is being exported for use in the investigation. A second route would permit exportation, without prior Food and Drug Administration (FDA) approval and without an IND, if the product is to be exported for use in a clinical investigation and has received marketing authorization in certain developed countries. The third route would permit exportation, without prior FDA approval and without an IND, if the product is to be exported for use in a clinical investigation in certain specified developed countries. The fourth route would permit exportation without an IND, to any country provided that the exporter sends a written certification to FDA at the time the drug is first exported. Drugs exported under any of the first three routes would, however, be subject to certain statutory requirements, such as not conflicting with the foreign country's laws and not being sold or offered for sale in the United States. Drugs exported under either the second or third routes would be subject to additional statutory requirements, such as being in substantial conformity with the current good manufacturing practices and certain labeling requirements. These provisions would implement changes in FDA's export authority resulting from the FDA Export Reform and Enhancement Act of 1996. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 06/19/02 67 FR 41642 Final Action 02/00/05 Regulatory Flexibility Analysis Required: No Government Levels Affected: None Agency Contact: Philip L. Chao, Senior Policy Analyst, Department of Health and Human Services, Food and Drug Administration, Room 15-61 (HF-23), Office of Policy and Planning, 5600 Fishers Lane, Rockville, MD 20857 Phone: 301 827-0587 Fax: 301 827-4774 Email: pchao@oc.fda.gov RIN: 0910-AA61 _______________________________________________________________________ 959. REQUIREMENTS ON CONTENT AND FORMAT OF LABELING FOR HUMAN PRESCRIPTION DRUGS AND BIOLOGICAL PRODUCTS Regulatory Plan: This entry is Seq. No. 47 in part II of this issue of the Federal Register. RIN: 0910-AA94 [[Page 73143]] _______________________________________________________________________ 960. SAFETY REPORTING REQUIREMENTS FOR HUMAN DRUG AND BIOLOGICAL PRODUCTS Regulatory Plan: This entry is Seq. No. 48 in part II of this issue of the Federal Register. RIN: 0910-AA97 _______________________________________________________________________ 961. CURRENT GOOD TISSUE PRACTICE FOR HUMAN CELL, TISSUE, AND CELLULAR AND TISSUE-BASED PRODUCT ESTABLISHMENTS; INSPECTION AND ENFORCEMENT Regulatory Plan: This entry is Seq. No. 49 in part II of this issue of the Federal Register. RIN: 0910-AB28 _______________________________________________________________________ 962. APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG; COMPLETE RESPONSE LETTER; AMENDMENTS TO UNAPPROVED APPLICATIONS Priority: Substantive, Nonsignificant. Major status under 5 USC 801 is undetermined. Unfunded Mandates: Undetermined Legal Authority: 21 USC 321; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 371; 21 USC 374; 21 USC 379e CFR Citation: 21 CFR 312; 21 CFR 314 Legal Deadline: None Abstract: The proposed rule would amend the regulations on marketing approval of new drugs to discontinue the use of approvable and not approvable letters when taking action on a marketing application and instead use complete response letters. The proposed rule would also amend the regulations on extension of the review clock because of amendments to applications. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 07/20/04 69 FR 43357 Final Action 11/00/05 Regulatory Flexibility Analysis Required: Undetermined Government Levels Affected: Undetermined Federalism: Undetermined Agency Contact: Brian L. Pendleton, Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, Suite 3037 (HFD-7), Center for Drug Evaluation and Research, 5515 Security Lane, Suite 1101 (HFD-7), Rockville, MD 20852 Phone: 301 594-2041 Fax: 301 827-5562 Email: pendletonb@cder.fda.gov RIN: 0910-AB34 _______________________________________________________________________ 963. CGMPS FOR BLOOD AND BLOOD COMPONENTS: NOTIFICATION OF CONSIGNEES AND TRANSFUSION RECIPIENTS RECEIVING BLOOD AND BLOOD COMPONENTS AT INCREASED RISK OF TRANSMITTING HCV INFECTION (LOOKBACK) Regulatory Plan: This entry is Seq. No. 50 in part II of this issue of the Federal Register. RIN: 0910-AB76 _______________________________________________________________________ 964. CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKING, OR HOLDING DIETARY INGREDIENTS AND DIETARY SUPPLEMENTS Regulatory Plan: This entry is Seq. No. 51 in part II of this issue of the Federal Register. RIN: 0910-AB88 _______________________________________________________________________ 965. ADDITIONAL SAFEGUARDS FOR CHILDREN IN CLINICAL INVESTIGATIONS OF FDA-REGULATED PRODUCTS Priority: Other Significant. Major status under 5 USC 801 is undetermined. Unfunded Mandates: Undetermined Legal Authority: 21 USC 321; 21 USC 343; 21 USC 346; 21 USC 346a; 21 USC 348; 21 USC 350a; 21 USC 350b; 21 USC 351 to 353; 21 USC 355; 21 USC 360; 21 USC 360c to 360f; 21 USC 360h to 360j; 21 USC 371; 21 USC 379e; 21 USC 381; 41 USC 216; 41 USC 241; 41 USC 262; 41 USC 263b to 263n CFR Citation: 21 CFR 50; 21 CFR 56 Legal Deadline: Final, Statutory, April 17, 2001. Abstract: The final rule will finalize the interim rule that published in April 2001, providing additional protections for children involved as subjects in clinical investigations of FDA-regulated products, as required by the Children's Health Act of 2000. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Interim Rule 04/24/01 66 FR 20589 Final Action 05/00/05 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Carol Drew, Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, Suite 3037 (HFD-7), Center for Drug Evaluation and Research, 5515 Security Lane, Suite 1101 (HFD-7), Rockville, MD 20852 Phone: 301 594-2041 Fax: 301 827-5562 RIN: 0910-AC07 _______________________________________________________________________ 966. PREVENTION OF SALMONELLA ENTERITIDIS IN SHELL EGGS Regulatory Plan: This entry is Seq. No. 52 in part II of this issue of the Federal Register. RIN: 0910-AC14 _______________________________________________________________________ 967. INSTITUTIONAL REVIEW BOARDS: REGISTRATION REQUIREMENTS Priority: Info./Admin./Other Legal Authority: 21 USC 321; 21 USC 346; 21 USC 346a; 21 USC 348; 21 USC 351 to 353; 21 USC 355; 21 USC 360; 21 USC 360c to 360f; 21 USC 360h to 360j; 21 USC 371; 21 USC 379e; 21 USC 381; 42 USC 216; 42 USC 241; 42 USC 262; 42 USC 263b to 263n CFR Citation: 21 CFR 56.106 Legal Deadline: None Abstract: The final rule would require institutional review boards (IRB) to register with FDA. The registration information would include the name of the IRB, the name of the institution operating the IRB, and names, addresses, phone numbers, facsimile (fax) numbers, and electronic mail (e-mail) addresses of the senior officer of the institution and IRB chair or contact, the range of active protocols (small, medium, or large) involving FDA-regulated products reviewed in the previous calendar year, and a description of the types of FDA- regulated products reviewed. The final rule would make it easier for FDA to [[Page 73144]] inspect IRBs and to convey information to IRBs. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 07/06/04 69 FR 40556 Final Action 04/00/05 Regulatory Flexibility Analysis Required: Undetermined Government Levels Affected: None Agency Contact: Philip L. Chao, Senior Policy Analyst, Department of Health and Human Services, Food and Drug Administration, Room 15-61 (HF-23), Office of Policy and Planning, 5600 Fishers Lane, Rockville, MD 20857 Phone: 301 827-0587 Fax: 301 827-4774 Email: pchao@oc.fda.gov RIN: 0910-AC17 _______________________________________________________________________ 968. MEDICAL DEVICES; PATIENT EXAMINATION AND SURGEONS' GLOVES; ADULTERATION Priority: Substantive, Nonsignificant Legal Authority: 21 USC 321; 21 USC 331; 21 USC 351; 21 USC 352; 21 USC 371; 21 USC 374 CFR Citation: 21 CFR 800.20 Legal Deadline: None Abstract: The Food and Drug Administration (FDA) is proposing to amend the sampling plans, test method, and acceptable quality levels in 21 CFR 800.20. As prescribed by this regulation, FDA samples patient examination and surgeons' gloves and examines them for visual defects and water leaks. Glove lots are considered adulterated if they do not meet specified quality levels. This proposal would clarify sampling plans and the scoring of defects, lower acceptance rates for leaking gloves, raise rejection rates for leaking gloves, and add tightened inspection schemes for reexamined glove lots. The rule is intended to facilitate industry compliance and enhance the safety and effectiveness of gloves. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 03/31/03 68 FR 15404 NPRM Comment Period End 06/30/03 Final Action 03/00/05 Regulatory Flexibility Analysis Required: No Government Levels Affected: Undetermined Federalism: Undetermined Agency Contact: Joseph M. Sheehan, Chief, Regulations Staff, Department of Health and Human Services, Food and Drug Administration, HFZ-215, Center for Devices and Radiological Health, HFZ-215, 1350 Piccard Drive, Rockville, MD 20850 Phone: 301 827-2974 Fax: 301 594-4765 Email: joseph.sheehan@fda.hhs.gov RIN: 0910-AC32 _______________________________________________________________________ 969. AMENDMENTS TO THE PERFORMANCE STANDARD FOR DIAGNOSTIC X-RAY SYSTEMS AND THEIR MAJOR COMPONENTS Priority: Economically Significant. Major under 5 USC 801. Legal Authority: 21 USC 351; 21 USC 352; 21 USC 360e to 360j; 21 USC 360hh to 360ss; 21 USC 371; 21 USC 381 CFR Citation: 21 CFR 1020.30; 21 CFR 1020.31; 21 CFR 1020.32; 21 CFR 1020.33 Legal Deadline: None Abstract: This rule amends the performance standard for diagnostic x- ray systems and their components in 21 CFR 1020.30, 1020.31, 1020.32, and 1020.33 to address the changes in technology and practice. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 12/10/02 67 FR 76056 Final Action 12/00/04 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: None Agency Contact: Joseph M. Sheehan, Chief, Regulations Staff, Department of Health and Human Services, Food and Drug Administration, HFZ-215, Center for Devices and Radiological Health, HFZ-215, 1350 Piccard Drive, Rockville, MD 20850 Phone: 301 827-2974 Fax: 301 594-4765 Email: joseph.sheehan@fda.hhs.gov RIN: 0910-AC34 _______________________________________________________________________ 970. TOLL-FREE NUMBER FOR REPORTING ADVERSE EVENTS ON LABELING FOR HUMAN DRUGS Regulatory Plan: This entry is Seq. No. 53 in part II of this issue of the Federal Register. RIN: 0910-AC35 _______________________________________________________________________ 971. ESTABLISHMENT AND MAINTENANCE OF RECORDS PURSUANT TO THE PUBLIC HEALTH SECURITY AND BIOTERRORISM PREPAREDNESS AND RESPONSE ACT OF 2002 Regulatory Plan: This entry is Seq. No. 54 in part II of this issue of the Federal Register. RIN: 0910-AC39 _______________________________________________________________________ 972. REGISTRATION OF FOOD AND ANIMAL FEED FACILITIES Regulatory Plan: This entry is Seq. No. 55 in part II of this issue of the Federal Register. RIN: 0910-AC40 _______________________________________________________________________ 973. PRIOR NOTICE OF IMPORTED FOOD UNDER THE PUBLIC HEALTH SECURITY AND BIOTERRORISM PREPAREDNESS AND RESPONSE ACT OF 2002 Regulatory Plan: This entry is Seq. No. 56 in part II of this issue of the Federal Register. RIN: 0910-AC41 _______________________________________________________________________ 974. HUMAN SUBJECT PROTECTION; FOREIGN CLINICAL STUDIES NOT CONDUCTED UNDER AN INVESTIGATIONAL NEW DRUG APPLICATION Priority: Substantive, Nonsignificant. Major status under 5 USC 801 is undetermined. Unfunded Mandates: Undetermined Legal Authority: 21 USC 355(d)(5); 21 USC 355(i); 21 USC 371(a); 42 USC 262(a)(2)(A); 42 USC 262(a)(2)(B)(i)(l) CFR Citation: 21 CFR 312.120 Legal Deadline: None Abstract: This final rule follows a proposed rule, which proposed to update the standards for the acceptance of foreign clinical studies not conducted under an investigational new drug application (IND) as support for an IND or marketing application for [[Page 73145]] a drug or biological product. We proposed to replace the requirement in 21 CFR 312.120 that non-IND foreign clinical studies be conducted in accordance with ethical principles stated in the Declaration of Helsinki or with the laws and regulations of the country that is the research site, whichever provide greater protection to subjects. We would replace that with a requirement that such studies be conducted in accordance with good clinical practice (GCP), including review and approval by an independent ethics committee. The proposed GCP standard is consistent with the standard of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use for GCP and is sufficiently flexible to accommodate differences in how countries regulate the conduct of clinical research and obtain the informed consent of patients. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 06/10/04 69 FR 32467 Final Action 06/00/05 Regulatory Flexibility Analysis Required: No Small Entities Affected: Businesses Government Levels Affected: None Agency Contact: Brian L. Pendleton, Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, Suite 3037 (HFD-7), Center for Drug Evaluation and Research, 5515 Security Lane, Suite 1101 (HFD-7), Rockville, MD 20852 Phone: 301 594-2041 Fax: 301 827-5562 Email: pendletonb@cder.fda.gov RIN: 0910-AF15 _______________________________________________________________________ 975. USE OF OZONE-DEPLETING SUBSTANCES: REMOVAL OF ESSENTIAL USE DESIGNATION; ALBUTEROL Regulatory Plan: This entry is Seq. No. 57 in part II of this issue of the Federal Register. RIN: 0910-AF18 _______________________________________________________________________ 976. BLOOD INITIATIVE--REVISIONS TO LABELING AND STORAGE REQUIREMENTS FOR BLOOD AND BLOOD COMPONENTS, INCLUDING SOURCE PLASMA Priority: Other Significant. Major status under 5 USC 801 is undetermined. Legal Authority: 21 USC 321; 21 USC 360j; 21 USC 351 to 353; 21 USC 355; 21 USC 360; 21 USC 371; 21 USC 374; 42 USC 216; 42 USC 262; 42 USC 263; 42 USC 263a; 42 USC 264; 42 USC 300aa to 25; 21 USC 331; 21 USC 310 CFR Citation: 21 CFR 600; 21 CFR 606; 21 CFR 640 Legal Deadline: None Abstract: The Food and Drug Administration (FDA) is amending the labeling requirements for blood, blood components, and Source Plasma to be more consistent with current practices and to remove unnecessary or outdated requirements. This action is based on FDA's comprehensive review of the biologics regulations. It is also based on reports by the U.S. House of Representatives Committee on Government Reform and Oversight Subcommittee on House Resources and Intergovernmental Relations, the General Accounting Office, and the Institute of Medicine, as well as on public comments. This action is intended to help ensure the continued safety of the blood supply and to help ensure consistency in container labeling and storage temperatures. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 07/30/03 68 FR 44678 NPRM Comment Period End 10/28/03 Final Action 06/00/05 Regulatory Flexibility Analysis Required: No Small Entities Affected: Businesses Government Levels Affected: None Agency Contact: Paula S. McKeever, Regulatory Policy Analyst, Department of Health and Human Services, Food and Drug Administration, Suite 200N (HFM-17), Center for Biologics Evaluation and Research, 1401 Rockville Pike, Rockville, MD 20852-1448 Phone: 301 827-6210 Fax: 301 827-9434 Related RIN: Split from 0910-AB26 RIN: 0910-AF26 _______________________________________________________________________ 977. CURRENT GOOD MANUFACTURING PRACTICES; QUALITY CONTROL PROCEDURES; NOTIFICATION REQUIREMENTS; RECORDS AND REPORTS Priority: Other Significant Legal Authority: 21 USC 321; 21 USC 350a; 21 USC 371; . . . CFR Citation: 21 CFR 106; 21 CFR 107 Legal Deadline: None Abstract: The agency published a proposed rule on July 9, 1996, that would establish current good manufacturing practice regulations, quality control procedures, quality factors, notification requirements, and records and reports for the production of infant formula. This proposal was issued in response to the 1986 Amendments to the Infant Formula Act of 1980. On April 28, 2003, FDA reopened the comment period to update comments on the proposal. The comment period was extended on June 27, 2003, to end on August 26, 2003. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Final Action 09/00/05 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Melissa Scales, Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, HFS-800, HFS- 024, Center for Food Safety and Applied Nutrition, 5100 Paint Branch Parkway, College Park, MD 20740 Phone: 301 436-1720 Email: melissa.scales@cfsan.fda.gov Related RIN: Split from 0910-AA04 RIN: 0910-AF27 _______________________________________________________________________ 978. INFANT FORMULA QUALITY FACTORS Priority: Other Significant Legal Authority: 21 USC 321; 21 USC 350a; 21 USC 371; . . . CFR Citation: 21 CFR 106; 21 CFR 107 Legal Deadline: None Abstract: The agency published a proposed rule on July 9, 1996, that would establish current good manufacturing practice regulations, quality control procedures, quality [[Page 73146]] factors, notification requirements, and records and reports for the production of infant formula. This proposal was issued in response to the 1986 Amendments to the Infant Formula Act of 1980. On April 28, 2003, FDA reopened the comment period to update comments on the proposal. The comment period was extended on June 27, 2003, to end on August 26, 2003. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Final Action 09/00/05 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Melissa Scales, Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, HFS-800, HFS- 024, Center for Food Safety and Applied Nutrition, 5100 Paint Branch Parkway, College Park, MD 20740 Phone: 301 436-1720 Email: melissa.scales@cfsan.fda.gov Related RIN: Split from 0910-AA04 RIN: 0910-AF28 _______________________________________________________________________ 979. OVER-THE-COUNTER (OTC) DRUG REVIEW--COUGH/COLD (ANTIHISTAMINE) PRODUCTS Priority: Routine and Frequent Legal Authority: 21 USC 321p; 21 USC 351 to 353; 21 USC 355; 21 USC 360a; 21USC 371a; 21 USC 331; 21 USC 360; 21 USC 371 CFR Citation: 21 CFR 201; 21 CFR 310; 21 CFR 330 to 358 Legal Deadline: None Abstract: The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safe and effective and not misbranded. After a final monograph (i.e. final rule) is issued, only OTC drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. This action addresses labeling claims for the common cold. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Final Action (Amendment) (Common Cold) 04/00/05 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: None Agency Contact: Gerald M. Rachanow, Regulatory Counsel, Division of Over-the-Counter Drug Products, Department of Health and Human Services, Food and Drug Administration, HFD-560, Center for Drug Evaluation and Research, 5600 Fishers Lane, HFD-560, Rockville, MD 20857 Phone: 301 827-2241 Fax: 301 827-2315 Email: rachanow@cder.fda.gov Related RIN: Split from 0910-AA01 RIN: 0910-AF31 _______________________________________________________________________ 980. OVER-THE-COUNTER (OTC) DRUG REVIEW--OPHTHALMIC PRODUCTS Priority: Routine and Frequent Legal Authority: 21 USC 321p; 21 USC 351 to 353; 21 USC 355; 21 USC 360a; 21 USC 371a; 21 USC 331; 21 USC 360; 21 USC 371 CFR Citation: 21 CFR 201; 21 CFR 310; 21 CFR 330 to 358 Legal Deadline: None Abstract: The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safe and effective and not misbranded. After a final monograph (i.e. final rule) is issued, only OTC drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. This action addresses emergency first aid eyewash products. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Final Action (Emergency First Aid Eyewashes) 06/00/05 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: None Agency Contact: Gerald M. Rachanow, Regulatory Counsel, Division of Over-the-Counter Drug Products, Department of Health and Human Services, Food and Drug Administration, HFD-560, Center for Drug Evaluation and Research, 5600 Fishers Lane, HFD-560, Rockville, MD 20857 Phone: 301 827-2241 Fax: 301 827-2315 Email: rachanow@cder.fda.gov Related RIN: Split from 0910-AA01 RIN: 0910-AF39 _______________________________________________________________________ 981. OVER-THE-COUNTER (OTC) DRUG REVIEW--SKIN PROTECTANT PRODUCTS Priority: Routine and Frequent Legal Authority: 21 USC 321p; 21 USC 351 to 353; 21 USC 355; 21 USC 360a; 21 USC 371a; 21 USC 331; 21 USC 360; 21 USC 371 CFR Citation: 21 CFR 201; 21 CFR 310; 21 CFR 330 to 358 Legal Deadline: None Abstract: The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safe and effective and not misbranded. After a final monograph (i.e. final rule) is issued, only OTC drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. This action addresses labeling for products formulated and marketed as lip protectants. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Final Action (Technical Amendments) 01/00/05 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: None Agency Contact: Gerald M. Rachanow, Regulatory Counsel, Division of Over-the-Counter Drug Products, Department of Health and Human Services, Food and Drug Administration, HFD-560, Center for Drug Evaluation and Research, 5600 Fishers Lane, HFD-560, Rockville, MD 20857 Phone: 301 827-2241 Fax: 301 827-2315 Email: rachanow@cder.fda.gov Related RIN: Split from 0910-AA01 RIN: 0910-AF42 _______________________________________________________________________ 982. OVER-THE-COUNTER (OTC) DRUG REVIEW--VAGINAL CONTRACEPTIVE PRODUCTS Priority: Routine and Frequent Legal Authority: 21 USC 321p; 21 USC 351 to 353; 21 USC 355; 21 USC 360a; [[Page 73147]] 21 USC 371a; 21 USC 331; 21 USC 358; 21 USC 360; 21 USC 360gg to 360ss; 21 USC 371; 21 USC 374; 21 USC 379e; 42 USC 216; 42 USC 241; 42 USC 262; 42 USC 264 CFR Citation: 21 CFR 201; 21 CFR 310; 21 CFR 330 to 358 Legal Deadline: None Abstract: The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safe and effective and not misbranded. After a final monograph (i.e. final rule) is issued, only OTC drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. This action addresses labeling warning statements for products containing nonoxynol 9. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Final Action (Warnings) 04/00/05 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: None Agency Contact: Gerald M. Rachanow, Regulatory Counsel, Division of Over-the-Counter Drug Products, Department of Health and Human Services, Food and Drug Administration, HFD-560, Center for Drug Evaluation and Research, 5600 Fishers Lane, HFD-560, Rockville, MD 20857 Phone: 301 827-2241 Fax: 301 827-2315 Email: rachanow@cder.fda.gov Related RIN: Split from 0910-AA01 RIN: 0910-AF44 _______________________________________________________________________ 983. USE OF MATERIALS DERIVED FROM CATTLE IN HUMAN FOOD AND COSMETICS Regulatory Plan: This entry is Seq. No. 58 in part II of this issue of the Federal Register. RIN: 0910-AF47 _______________________________________________________________________ 984. RECORDKEEPING REQUIREMENTS FOR HUMAN FOOD AND COSMETICS MANUFACTURED FROM, PROCESSED WITH, OR OTHERWISE CONTAINING MATERIAL FROM CATTLE Regulatory Plan: This entry is Seq. No. 59 in part II of this issue of the Federal Register. RIN: 0910-AF48 _______________________________________________________________________ 985. OVER-THE-COUNTER (OTC) DRUG REVIEW--ANTACID PRODUCTS (SODIUM BICARBONATE LABELING) Priority: Routine and Frequent Legal Authority: 21 USC 321p; 21 USC 351 to 353; 21 USC 355; 21 USC 360; 21 USC 360a; 21 USC 371; 21 USC 371a; 21 USC 331 CFR Citation: 21 CFR 201; 21 CFR 310; 21 CFR 330 to 358 Legal Deadline: None Abstract: The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safe and effective and not misbranded. After a final monograph (i.e. final rule) is issued, only OTC drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. This action addresses the labeling of products containing sodium bicarbonate as an active ingredient. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Final Action 06/00/05 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: None Agency Contact: Gerald M. Rachanow, Regulatory Counsel, Division of Over-the-Counter Drug Products, Department of Health and Human Services, Food and Drug Administration, HFD-560, Center for Drug Evaluation and Research, 5600 Fishers Lane, HFD-560, Rockville, MD 20857 Phone: 301 827-2241 Fax: 301 827-2315 Email: rachanow@cder.fda.gov RIN: 0910-AF52 _______________________________________________________________________ Department of Health and Human Services (HHS) Long-Term Actions Food and Drug Administration (FDA) _______________________________________________________________________ 986. REQUIREMENTS PERTAINING TO SAMPLING SERVICES AND PRIVATE LABORATORIES USED IN CONNECTION WITH IMPORTED FOOD Priority: Routine and Frequent Legal Authority: 21 USC 331 to 334; 21 USC 341 to 344; 21 USC 348; 21 USC 371; 21 USC 372; 21 USC 374; 21 USC 376; 21 USC 381; 21 USC 393; 42 USC 264 CFR Citation: 21 CFR 59 Legal Deadline: None Abstract: The final rule would establish requirements for importers and other persons who use sampling services and private laboratories in connection with imported food. For example, the rule would pertain to persons who use sample collection services and private laboratories, and would describe some responsibilities for such persons, sample collection services, and private laboratories. These responsibilities would include recordkeeping requirements to ensure that the correct sample is collected and analyzed, and a notification requirement if a person intends to use a sampling service or a private laboratory in connection with imported food. The final rule is intended to help insure the integrity and scientific validity of data and results submitted to FDA. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 04/29/04 69 FR 23460 Final Action To Be Determined Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: Undetermined Agency Contact: Philip L. Chao, Senior Policy Analyst, Department of Health and Human Services, Food and Drug Administration, Room 15-61 (HF-23), Office of Policy and Planning, 5600 Fishers Lane, Rockville, MD 20857 Phone: 301 827-0587 Fax: 301 827-4774 [[Page 73148]] Email: pchao@oc.fda.gov RIN: 0910-AB96 _______________________________________________________________________ 987. CHRONIC WASTING DISEASE: CONTROL OF FOOD PRODUCTS AND COSMETICS DERIVED FROM EXPOSED ANIMAL POPULATIONS Priority: Other Significant Legal Authority: 42 USC 264; 21 USC 301 et seq CFR Citation: Not Yet Determined Legal Deadline: None Abstract: The Food and Drug Administration (FDA) is proposing to prohibit the use of cervids (deer, elk) for food, including dietary supplements, and cosmetics if the cervids have been exposed to chronic wasting disease (CWD). FDA is proposing this regulation because of potential risks to health. CWD is a type of transmissible spongiform encephalopathy (TSE), a group of fatal, neurodegenerative diseases that include bovine spongiform encephalopathy (BSE) in cattle, scrapie in sheep and goats, and Creutzfeldt-Jakob disease (CJD) in humans. The disease has been identified in wild and farmed elk and wild deer populations. CWD has been found in cervid populations in certain areas of Wisconsin, Colorado, Nebraska, Wyoming, Kansas, Montana, Oklahoma, South Dakota, New Mexico, Minnesota, and Canada. In 1999, the World Health Organization said there is no evidence that CWD transmits to humans. However, it also suggested any part of a deer or elk believed to be diseased should not be eaten. Results of some studies using in vitro techniques have suggested that transmission to humans could possibly occur. However, if it does occur, it is likely to be through a very inefficient process. Currently, there are no validated analytical tests to identify animals in the preclinical phase of CWD, or any other TSE. In addition, no test exists to ensure food safety. CWD typically exhibits a long incubation period, during which time animals appear normal but are potentially infectious. Therefore, DA is proposing to require that food or cosmetic products derived from animals exposed to CWD not enter into commerce. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 01/00/06 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: Undetermined Federalism: Undetermined Agency Contact: Rebecca Buckner, Consumer Safety Officer, Department of Health and Human Services, Food and Drug Administration, HFS-306, Center for Food Safety and Applied Nutrition, 5100 Paint Branch Parkway, HFS-366, College Park, MD 20740 Phone: 301 436-1486 Fax: 301 436-2632 Email: rebecca.buckner@cfsan.fda.gov RIN: 0910-AC21 _______________________________________________________________________ 988. REQUIREMENTS FOR SUBMISSION OF IN VIVO BIOEQUIVALENCE DATA Priority: Substantive, Nonsignificant Legal Authority: 21 USC 321; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 355a; 21 USC 356; 21 USC 356a to 356c; 21 USC 371; 21 USC 374; 21 USC 379 CFR Citation: 21 CFR 314.96(a)(1); 21 CFR 314.94(a)(7); 21 CFR 320.21(b)(1) Legal Deadline: None Abstract: The Food and Drug Administration (FDA) is proposing to amend its regulations on submission of bioequivalence (BE) data to require an abbreviated new drug application (ANDA) applicant to submit data from all BE studies the applicant conducts on a drug product formulation submitted for approval. In the past, ANDA applicants have submitted BE studies demonstrating that a generic product meets BE criteria for FDA to approve the ANDA but have not typically submitted additional BE studies conducted on the same drug product formulation. FDA is proposing to require ANDA applicants to submit information, in either a complete or summary report, from all additional passing and nonpassing BE studies conducted on the same drug product formulation submitted for approval. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 10/29/03 68 FR 61640 Final Action To Be Determined Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: None Agency Contact: Aileen Ciampa, Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, HFD-7, Center for Drug Evaluation and Research, 5515 Security Lane, Suite 1101 (HFD-7), Rockville, MD 20857 Phone: 301 594-2041 Fax: 301 827-5562 RIN: 0910-AC23 _______________________________________________________________________ 989. EXCEPTION FROM GENERAL REQUIREMENTS FOR INFORMED CONSENT; REQUEST FOR COMMENTS AND INFORMATION Priority: Other Significant Legal Authority: 21 USC 321; 21 USC 351; 21 USC 352; 21 USC 355; 21 USC 360; 21 USC 360bbb; 21 USC 360c; 21 USC 360d; 21 USC 360e; 21 USC 360f; 21 USC 360h; 21 USC 360i; 21 USC 360j; 21 USC 371; 21 USC 381 CFR Citation: 21 CFR 50.23 Legal Deadline: None Abstract: FDA is proposing to add an exception from the general requirement for informed consent in certain circumstances involving the use of investigational in vitro diagnostic devices to identify chemical, biological, radiological, or nuclear agents in a potential terrorist event or other public health emergency. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 12/00/05 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Catherine Lorraine, Director, Policy Development and Coordination Group, Department of Health and Human Services, Food and Drug Administration, 14-101-11, 5600 Fishers Lane, Rockville, MD 20857 Phone: 301 827-3360 Fax: 301 827-6777 RIN: 0910-AC25 [[Page 73149]] _______________________________________________________________________ 990. FOOD LABELING: TRANS FATTY ACIDS IN NUTRITION LABELING: CONSUMER RESEARCH TO CONSIDER NUTRIENT CONTENT AND HEALTH CLAIMS AND POSSIBLE FOOTNOTE OR DISCLOSURE STATEMENTS Priority: Other Significant Legal Authority: 21 USC 321; 21 USC 343; 21 USC 371 CFR Citation: 21 CFR 101 Legal Deadline: None Abstract: The Food and Drug Administration issued an advance noitce of proposed rulemaking on July 11, 2003 (68 FR 41507), to solicit information and data that potentially could be used to establish new nutrient content claims about trans fatty acids; to establish qualifying criteria for trans fat in current nutrient content claims for saturated fat and cholesterol, lean and extra lean claims, and health claims that contain a message about cholesterol-raising lipids; and, in addition, to establish disclosure and disqualifying criteria to help consumers make heart-healthy food choices. The agency also requested comments on whether it should consider statements about trans fat, either alone or in combination with saturated fat and cholesterol, as a footnote in the Nutrition Facts panel or as a disclosure statement in conjunction with claims to enhance consumers' understanding about such cholesterol-raising lipids and how to use the information to make healthy food choices. Information and data obtained from comments and from consumer studies that will be conducted by FDA also may be used to help draft a proposed rule that would establish criteria for certain nutrient content or health claims or require the use of a footnote, or other labeling approach, about one or more cholesterol-raising lipids in the Nutrition Facts panel to assist consumers in maintaining healthy dietary practices. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ ANPRM 07/11/03 68 FR 41507 ANPRM Comment Period End 10/09/03 ANPRM Comment Period Reopened for 45 days 03/01/04 69 FR 9559 ANPRM Comment Period Extended for Additional 60 days 04/19/04 69 FR 20838 ANPRM Comment Period End 06/18/04 NPRM To Be Determined Regulatory Flexibility Analysis Required: No Government Levels Affected: Federal Agency Contact: Julie Schrimpf, Department of Health and Human Services, Food and Drug Administration, (HFS-832), HFS-800, Center for Food Safety and Applied Nutrition, 5100 Paint Branch Parkway, College Park, MD 20740 Phone: 301 436-2373 Fax: 301 436-2639 Email: julie.schrimpf@cfsan.fda.gov Related RIN: Related to 0910-AB66 RIN: 0910-AC50 _______________________________________________________________________ 991. FOOD LABELING: FOOD ALLERGEN INGREDIENT LABELING Priority: Other Significant. Major status under 5 USC 801 is undetermined. Legal Authority: 21 USC 321 ; 21 USC 331; 21 USC 343; 21 USC 371 CFR Citation: 21 CFR 101 Legal Deadline: None Abstract: FDA initially intended to issue a proposed rule to establish requirements for labeling foods that contain common food allergens. The purpose of this rulemaking was to reduce mortality and morbidity by making it easier for persons who have a food allergy to identify when packaged foods contain certain allergenic ingredients. Subsequently, on August 2, 2004, the President signed into law the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCP Act) (Pub. L. 108- 282), which amended sections 201 and 403 of the Federal, Food, Drug and Cosmetic Act (FFD&C Act). FDA is now in the process of determining the approach it intends to take in light of the new statutory requirements. The FALCP Act amended section 201 of the FFD&C Act to define a major food allergen as: 1) milk, egg, fish (e.g., bass, flounder, cod), Crustacean shellfish (e.g., crab, lobster, shrimp), tree nuts (e.g., almonds, pecans, walnuts), wheat, peanuts, and soybeans and 2) any ingredient that contains a protein derived from these foods. Excluded from this definition are: 1) highly refined oils derived from the food source of a major food allergen and ingredients derived from such oils and 2) a food ingredient that is exempt under the petition or notification process specified in the law. The FALCP Act also amended section 403 of the FFD&C Act to require that the labels of packaged foods use plain English terms to identify the food source of each of the major food allergens it contains as an ingredient. This requirement is applicable to all ingredients, including flavors, non-certified colors, and incidental additives. The law provides a choice between two methods for declaring the food sources of any major food allergens contained in the ingredients of packaged foods: either within the ingredient list or in a separate summary statement immediately following or adjacent to the ingredient list. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM To Be Determined Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: None Federalism: Undetermined Agency Contact: Rhonda Rhoda Kane M.S., R.D., Consumer Safety Officer, Department of Health and Human Services, Food and Drug Administration, HFS-820, Center for Food Safety and Applied Nutrition, 5100 Paint Branch Parkway, College Park, MD 20740 Phone: 301 436-2371 Fax: 301 436-2636 Email: rkane2@cfsan.fda.gov RIN: 0910-AF07 _______________________________________________________________________ 992. CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PROCESSING, PACKING, OR HOLDING OF DRUGS; REVISION OF CERTAIN LABELING CONTROLS Priority: Substantive, Nonsignificant. Major status under 5 USC 801 is undetermined. Unfunded Mandates: Undetermined Legal Authority: 21 USC 351 CFR Citation: 21 CFR 211.122 Legal Deadline: None Abstract: The proposed rule would amend the packaging and labeling [[Page 73150]] control provisions of the current good manufacturing practice regulations for human and veterinary drug products by limiting the application of special control procedures for the use of cut labeling to immediate container labels, individual unit cartons, or multiunit cartons containing immediate containers that are not packaged in individual unit cartons. The proposal would also permit the use of any automated technique, including differentiation by labeling size and shape, that physically prevents incorrect labeling from being processed by labeling and packaging equipment when cut labeling is used. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 07/29/97 62 FR 40489 Final Action To Be Determined Regulatory Flexibility Analysis Required: Undetermined Small Entities Affected: Businesses Government Levels Affected: None Federalism: Undetermined Agency Contact: Howard P. Muller, Office of Regulatory Policy, Department of Health and Human Services, Food and Drug Administration, Suite 3037 (HFD-7), Center for Drug Evaluation and Research, 5515 Security Lane, Suite 1101 (HFD-7), Rockville, MD 20852 Phone: 301 594-2041 Fax: 301 827-5562 Email: mullerh@cder.fda.gov RIN: 0910-AF08 _______________________________________________________________________ 993. OVER-THE-COUNTER (OTC) DRUG REVIEW--EXTERNAL ANALGESIC PRODUCTS Priority: Routine and Frequent Legal Authority: 21 USC 321p; 21 USC 351 to 353; 21 USC 355; 21 USC 360a; 21USC 371a; 21 USC 331; 21 USC 360; 21 USC 371 CFR Citation: 21 CFR 201; 21 CFR 310; 21 CFR 330 to 358 Legal Deadline: None Abstract: The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safe and effective and not misbranded. After a final monograph (i.e. final rule) is issued, only OTC drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. This action will address external analgesic drug products. Timetable: Next Action Undetermined Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: None Agency Contact: Gerald M. Rachanow, Regulatory Counsel, Division of Over-the-Counter Drug Products, Department of Health and Human Services, Food and Drug Administration, HFD-560, Center for Drug Evaluation and Research, 5600 Fishers Lane, HFD-560, Rockville, MD 20857 Phone: 301 827-2241 Fax: 301 827-2315 Email: rachanow@cder.fda.gov Related RIN: Split from 0910-AA01 RIN: 0910-AF35 _______________________________________________________________________ 994. OVER-THE-COUNTER (OTC) DRUG REVIEW--LAXATIVE DRUG PRODUCTS Priority: Routine and Frequent Legal Authority: 21 USC 321p; 21 USC 351 to 353; 21 USC 355; 21 USC 360a; 21USC 371a; 21 USC 331; 21 USC 360; 21 USC 371 CFR Citation: 21 CFR 201; 21 CFR 310; 21 CFR 330 to 358 Legal Deadline: None Abstract: The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safe and effective and not misbranded. After a final monograph (i.e. final rule) is issued, only OTC drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. This action will address laxative drug products. Timetable: Next Action Undetermined Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: None Agency Contact: Gerald M. Rachanow, Regulatory Counsel, Division of Over-the-Counter Drug Products, Department of Health and Human Services, Food and Drug Administration, HFD-560, Center for Drug Evaluation and Research, 5600 Fishers Lane, HFD-560, Rockville, MD 20857 Phone: 301 827-2241 Fax: 301 827-2315 Email: rachanow@cder.fda.gov Related RIN: Split from 0910-AA01 RIN: 0910-AF38 _______________________________________________________________________ 995. OVER-THE-COUNTER (OTC) DRUG REVIEW--ORAL HEALTH CARE PRODUCTS Priority: Routine and Frequent Legal Authority: 21 USC 321p; 21 USC 351 to 353; 21 USC 355; 21 USC 360a; 21 USC 371a; 21 USC 331; 21 USC 360; 21 USC 371 CFR Citation: 21 CFR 201; 21 CFR 310; 21 CFR 330 to 358 Legal Deadline: None Abstract: The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safe and effective and not misbranded. After a final monograph (i.e. final rule) is issued, only OTC drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. This action will address oral health care products. Timetable: Next Action Undetermined Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: None Agency Contact: Gerald M. Rachanow, Regulatory Counsel, Division of Over-the-Counter Drug Products, Department of Health and Human Services, Food and Drug Administration, HFD-560, Center for Drug Evaluation and Research, 5600 Fishers Lane, HFD-560, Rockville, MD 20857 Phone: 301 827-2241 Fax: 301 827-2315 Email: rachanow@cder.fda.gov Related RIN: Split from 0910-AA01 RIN: 0910-AF40 [[Page 73151]] _______________________________________________________________________ Department of Health and Human Services (HHS) Completed Actions Food and Drug Administration (FDA) _______________________________________________________________________ 996. PRESUBMISSION CONFERENCES Priority: Substantive, Nonsignificant CFR Citation: 21 CFR 514 Completed: ________________________________________________________________________ Reason Date FR Cite ________________________________________________________________________ Final Action 08/18/04 69 FR 51162 Regulatory Flexibility Analysis Required: No Government Levels Affected: None Agency Contact: Gail Schmerfeld Phone: 301 827-0205 Related RIN: Previously reported as 0910-AB68 RIN: 0910-AC44 _______________________________________________________________________ 997. DEFINITION OF ``SERIOUS ADVERSE HEALTH CONSEQUENCES'' UNDER THE PUBLIC HEALTH SECURITY AND BIOTERRORISM PREPAREDNESS AND RESPONSE ACT OF 2002 Priority: Other Significant. Major status under 5 USC 801 is undetermined. CFR Citation: 21 CFR 1.3(c) Completed: ________________________________________________________________________ Reason Date FR Cite ________________________________________________________________________ Withdrawn 10/07/04 Regulatory Flexibility Analysis Required: No Small Entities Affected: Businesses Government Levels Affected: None Agency Contact: Karen Carson Phone: 301 436-1664 Fax: 301 436-2632 Email: karen.carson@cfsan.fda.gov John E. Kvenberg Phone: 301 436-2359 Fax: 301 436-2717 Email: john.kvenberg@cfsan.fda.gov RIN: 0910-AF06 _______________________________________________________________________ 998. OVER-THE-COUNTER (OTC) DRUG REVIEW--ANTIPERSPIRANT PRODUCTS Priority: Routine and Frequent CFR Citation: 21 CFR 201; 21 CFR 310; 21 CFR 330 to 358 Completed: ________________________________________________________________________ Reason Date FR Cite ________________________________________________________________________ Final Action (Partial Stay) 10/15/04 69 FR 61148 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: None Agency Contact: Gerald M. Rachanow Phone: 301 827-2241 Fax: 301 827-2315 Email: rachanow@cder.fda.gov Related RIN: Split from 0910-AA01 RIN: 0910-AF30 _______________________________________________________________________ 999. OVER-THE-COUNTER (OTC) DRUG REVIEW--SODIUM LABELING FOR OVER-THE COUNTER DRUGS Priority: Routine and Frequent Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 358; 21 USC 360; 21 USC 360a; 21 USC 360gg to 360ss; 21 USC 371; 21 USC 371a; 21 USC 374; 21 USC 379e; 42 USC 216; 42 USC 241; 42 USC 262; 42 USC 264 CFR Citation: 21 CFR 201; 21 CFR 310; 21 CFR 330 to 358 Legal Deadline: None Abstract: The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safe and effective and not misbranded. After a final monograph (i.e. final rule) is issued, only OTC drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. This action addresses sodium content labeling for rectal drug products containing sodium phosphates. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Final Action 11/29/04 69 FR 69278 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: None Agency Contact: Gerald M. Rachanow, Regulatory Counsel, Division of Over-the-Counter Drug Products, Department of Health and Human Services, Food and Drug Administration, HFD-560, Center for Drug Evaluation and Research, 5600 Fishers Lane, HFD-560, Rockville, MD 20857 Phone: 301 827-2241 Fax: 301 827-2315 Email: rachanow@cder.fda.gov RIN: 0910-AF50 _______________________________________________________________________ Department of Health and Human Services (HHS) Proposed Rule Stage Health Resources and Services Administration (HRSA) _______________________________________________________________________ 1000. NATIONAL PRACTITIONER DATA BANK FOR ADVERSE INFORMATION ON PHYSICIANS AND OTHER HEALTH CARE PRACTITIONERS: MEDICAL MALPRACTICE PAYMENTS REPORTING REQUIREMENTS Priority: Substantive, Nonsignificant Legal Authority: 42 USC 11131 CFR Citation: 45 CFR 60.7 Legal Deadline: None Abstract: This notice of proposed rulemaking (NPRM) proposes to require that, in addition to reporting to the National Practitioner Data Bank medical malpractice payments made where physicians or other health care practitioners are named in medical malpractice actions or claims, judgments, or settlements, payments be reported where they are made for the benefit of physicians or other health care practitioners not named in the judgments or settlements but who furnished or failed to furnish the health care services upon which the actions or claims were based. The purpose of this NPRM is to prevent the evasion of the medical malpractice payment reporting requirement of the Data Bank through the agreement of the parties to a lawsuit to use the corporate health care entity to ``shield'' practitioners. It would also require malpractice payers, in very limited circumstances, when it is impossible to identify the practitioner who furnished or failed to furnish the health care services upon which the actions or claims were based, to report why the practitioner could not be identified, and to provide the name of the corporate health care entity. [[Page 73152]] Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 12/24/98 63 FR 71255 Second NPRM 07/00/05 Regulatory Flexibility Analysis Required: No Government Levels Affected: None Agency Contact: Mark S. Pincus, Director, Division of Practitioner Data Banks, Department of Health and Human Services, Health Resources and Services Administration, Suite 300, 7519 Standish Place, Rockville, MD 20857 Phone: 301 443-2300 RIN: 0906-AA41 _______________________________________________________________________ 1001. DESIGNATION OF MEDICALLY UNDERSERVED POPULATIONS AND HEALTH PROFESSIONAL SHORTAGE AREAS Priority: Substantive, Nonsignificant Legal Authority: 42 USC 254b; 42 USC 254e CFR Citation: 42 CFR 5; 42 CFR 51c Legal Deadline: None Abstract: This rule would consolidate the process for designating areas of health professional shortage and medical underservice that apply in several department programs, and would improve the criteria for designating medically underserved populations and Primary Care Health Professional Shortage Areas. This notice of proposed rulemaking (NPRM) will address issues raised by comments received in a previous NPRM, dated September 1, 1998. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 09/01/98 63 FR 46538 Second NPRM 11/00/04 Regulatory Flexibility Analysis Required: No Government Levels Affected: None Agency Contact: Andy Jordan, Acting Chief, Shortage Designation Branch, Department of Health and Human Services, Health Resources and Services Administration, Room 8C26, National Center for Health Workforce Analysis, Bureau of Health Professions, Parklawn Building, Rockville, MD 20857 Phone: 301 594-0197 Email: dsd@hrsa.gov RIN: 0906-AA44 _______________________________________________________________________ 1002. INTESTINES ADDED TO THE DEFINITION OF ORGANS COVERED BY THE RULES GOVERNING THE OPERATION OF THE ORGAN PROCUREMENT AND TRANSPLANTATION NETWORK (OPTN) Priority: Other Significant. Major status under 5 USC 801 is undetermined. Legal Authority: 42 USC 274e, sec 301; 42 USC 273 to 274d, sec 371 to 376; 42 USC 1320b-8, sec 1138 CFR Citation: 42 CFR 121 Legal Deadline: None Abstract: The Department of Health and Human Services proposes to add intestines to the definition of organs covered by the rules governing the operation of the OPTN. After a review of intestinal transplants, HHS believes that intestines should now be included within the definition. The notice of proposed rulemaking provides the history of intestinal transplants, the factors that have persuaded HHS of the advisability of including intestines within the scope of the regulations governing the operation of the OPTN, and the anticipated consequences of this proposal. As the field of intestinal transplantation evolves, it becomes more critical that intestinal organ allocation policies keep pace with the advances in the field; that policy development include performance indicators to assess how well the policies achieve the goals of an equitable transplant system; that those policies are enforceable; and that patients and physicians have timely access to accurate data that will assist them in making decisions regarding intestinal transplantation. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 11/00/04 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Dr. Laura St. Martin, Chief Medical Officer, Department of Health and Human Services, Health Resources and Services Administration, 5600 Fishers Lane, Room 12C-04, Parklawn Bldg., Rockville, MD 20857 Phone: 301 443-4423 Email: lstmartin@hrsa.gov RIN: 0906-AA62 _______________________________________________________________________ 1003. NATIONAL VACCINE INJURY COMPENSATION PROGRAM; REVISIONS AND ADDITIONS TO THE VACCINE INJURY TABLE Priority: Other Significant. Major status under 5 USC 801 is undetermined. Legal Authority: 42 USC 300aa-14, sec 2114; PL 103-66, sec 13632(a) CFR Citation: 42 CFR 100 Legal Deadline: None Abstract: The Department of Health and Human Services (HHS) is proposing to revise and make additions to the Vaccine Injury Table (Table). Section 2114(e) (2) of the Public Health Service Act provides for the inclusion of additional vaccines in the National Vaccine Injury Compensation Program when they are recommended by the Centers for Disease Control and Prevention for routine administration to children. In compliance with the Omnibus Budget Reconciliation Act of 1993, which added a new section 2114(e) (3) to the Act, a vaccine added to the Table through Section 2114(e) will be included in the Table, effective when an excise tax to provide funds for the payment of compensation with respect to such vaccines takes effect. HHS has determined that there are no resources required to implement these changes. Section 2114 (c) permits the Secretary of HHS to modify the Table. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 11/00/04 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Dr. Geoffrey Evans, Medical Director, Division of Vaccine Injury Compensation, Department of Health and Human Services, Health Resources and Services Administration, 5600 Fishers Lane, Room 16C-17, Rockville, MD 20857 Phone: 301 443-4198 Fax: 301 443 8196 Email: gevansr@hrsa.gov RIN: 0906-AA66 [[Page 73153]] _______________________________________________________________________ 1004. NATIONAL VACCINE INJURY COMPENSATION PROGRAM: CALCULATION OF AVERAGE COST OF A HEALTH INSURANCE POLICY Priority: Info./Admin./Other. Major status under 5 USC 801 is undetermined. Legal Authority: Not Yet Determined CFR Citation: 42 CFR 100, sec 100.2 Legal Deadline: None Abstract: The Department of Health and Human Services (HHS) is proposing to revise the current method for calculating the average cost of a health insurance policy, which is an amount deducted from the award of compensation in certain cases. According to the Final Rule published on June 24, 1992, which established the current calculation, ``lf, over time, the average cost of health insurance, as calculated by the method described above, significantly differs from subsequent HIAA survey results or other authoritative sources then available, the Secretary of HHS will consider appropriate revisions of this rule.`` 57 FR 28098 (June 24, 1992). When the latest average monthly of an individual health insurance policy was calculated based on the current methodology, it was significantly different from the Kaiser Family Foundation/Health Research and Educational Trust average monthly cost of an individual health insurance policy for the same time period. Therefore, the Secretary is proposing a new methodology to calculate the average cost of a health insurance policy. Subtitle 2 of title XXI of the Public Health Service Act, as enacted by the National Childhood Vaccine Injury Act of 1986, as amended, (the Act) governs the National Vaccine Injury Compensation Program (VICP). The VICP, administered by the Secretary of Health and Human Services (the Secretary) provides that a proceeding for compensation for a vaccine-related injury or death shall be initiated by service upon the Secretary, and the filing of a petition with the United States Court of Federal Claims (the Court). In some cases, the injured individual may receive compensation for future lost earnings, less appropriate taxes and the ``average cost of a health insurance policy, as determined by the Secretary.'' The elements of compensation that may be awarded to a successful petitioner are set out in section 2115 of the Public Service Act, 42 U.S.C. section 300aa-15. Subsection (a)(3)(B) specifically provides for compensation. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 11/00/04 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Thom E. Balbier Jr., Director, Division of Vaccine Injury Compensation, Department of Health and Human Services, Health Resources and Services Administration, Room 8A-46, Parklawn Building, 5600 Fishers Lane, Rockville, MD 20857 Phone: 301 443-6593 Fax: 301 443-8196 Email: tbalbier@hrsa.gov RIN: 0906-AA68 _______________________________________________________________________ 1005. REVISION TO 42 CFR SUBPART D--PUBLIC HEALTH SERVICE (PHS) GRANT APPEALS PROCEDURE Priority: Other Significant Legal Authority: 42 USC 216 CFR Citation: 42 CFR 50.402 Legal Deadline: None Abstract: The Health Resources and Services Administration (HRSA), an operating division under the U.S. Department of Health and Human Services, is proposing to no longer require its grantees to appeal certain adverse agency decisions to an ``informal'' appeals board (as outlined in 42 CFR part 50, subpart D--Public Health Service Grant Appeals Procedure) before exercising the right to appeal to the Departmental Appeals Board. In doing so, HRSA will join other PHS agencies (Substance Abuse and Mental Health Services Administration and the Indian Health Service) which no longer require the use of an informal appeal procedure. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 12/00/04 Interim Final Rule 02/00/05 Regulatory Flexibility Analysis Required: No Government Levels Affected: Undetermined Federalism: Undetermined Agency Contact: Gail Ellen Lipton, Director, Division of Grants Policy, Department of Health and Human Services, Health Resources and Services Administration, Room 11A-55, 5600 Fishers Lane, Rockville, MD 20857 Phone: 301 443-6509 Email: glipton@hrsa.gov RIN: 0906-AA69 _______________________________________________________________________ 1006. HEALTHY TOMORROW'S PARTNERSHIP FOR CHILDREN (HTPC) PROGRAM Priority: Other Significant. Major status under 5 USC 801 is undetermined. Legal Authority: Social Security Act, title V, sec 501(a)(2); Social Security Act, title V, sec 502(a)(1); 42 USC 701 CFR Citation: 42 CFR 51(a) Legal Deadline: None Abstract: In this rule, the HTPC is proposing to formally add a cost participation component to its grant program. This would require the grantees to have non-Federal matching funds and/or in-kind resources that are equal to or greater than $100,000 in years 2 through 5 of the 5-year project period. For example, in years 2-5, a project awarded $50,000 (i.e. the maximum annual award) of HTPC funds yearly would be expected to have, at a minimum, $100,000 in non-Federal matching funds each funding year. In this example, the $100,000 must come from alternate non-Federal funds, including, but not limited to, individuals, corporations, foundations, in-kind resources, or State and local agencies. Documentation of matching funds would be required (i.e., specific sources, funding level, in-kind contributions). Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 12/00/04 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Jose Belardo, Director, Healthy Tomorrow's Partnership for Children Program, Department of Health and Human Services, Health Resources and Services Administration, 5600 Fishers Lane, Room 18A-55, Rockville, MD 20857 [[Page 73154]] Phone: 301 443-0757 Email: jbelardo@hrsa.gov RIN: 0906-AA70 _______________________________________________________________________ Department of Health and Human Services (HHS) Final Rule Stage Health Resources and Services Administration (HRSA) _______________________________________________________________________ 1007. INTERIM FINAL RULE FOR THE SMALLPOX EMERGENCY PERSONNEL PROTECTION PROGRAM: SMALLPOX (VACCINIA) VACCINE INJURY TABLE Priority: Substantive, Nonsignificant. Major status under 5 USC 801 is undetermined. Legal Authority: PL 108-20, 117 Stat 638 CFR Citation: 42 CFR 102 Legal Deadline: None Abstract: To establish a table identifying adverse effects (including injuries, disabilities, conditions, and deaths) that shall be presumed to result from the administration of, or exposure to, the smallpox vaccine, and the time interval in which the first symptom or manifestation of each listed injury must manifest in order for such presumption to apply. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Interim Final Rule 08/27/03 68 FR 51492 Final Action 11/00/04 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Dr. Vito Caserta, Chief Medical Officer, Department of Health and Human Services, Health Resources and Services Administration, 10th Floor, 4350 East West Highway, Bethesda, MD 20814 Phone: 301 443-4956 Email: smallpox@hrsa.gov RIN: 0906-AA60 _______________________________________________________________________ 1008. SMALLPOX VACCINE INJURY COMPENSATION PROGRAM: ADMINISTRATIVE IMPLEMENTATION Priority: Other Significant. Major status under 5 USC 801 is undetermined. Legal Authority: PL 108-20, 117 Stat 638 CFR Citation: 42 CFR 102 Legal Deadline: None Abstract: To provide benefits to certain persons harmed as a result of receiving smallpox covered countermeasures, including the smallpox vaccine, or as a result of contracting vaccinia through accidental exposure to certain persons. The Secretary may also provide death benefits to certain survivors of people who died as a direct result of these injuries. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Interim Final Rule 11/00/04 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Paul T. Clark, Director, Smallpox Vaccine Injury Compensation Program, Department of Health and Human Services, Health Resources and Services Administration, 10th Floor HRSA/OSP, 4350 East West Highway, Bethesda, MD 20814 Phone: 888 496-0338 Email: small@hrsa.gov Related RIN: Related to 0906-AA60 RIN: 0906-AA61 _______________________________________________________________________ 1009. REQUIREMENTS ESTABLISHING A LIMITATION ON ADMINISTRATIVE EXPENSES; RYAN WHITE CARE ACT TITLE IV GRANTS FOR COORDINATED SERVICES AND ACCESS TO RESEARCH Priority: Other Significant. Major status under 5 USC 801 is undetermined. Legal Authority: 42 USC 300ff-71 CFR Citation: Not Yet Determined Legal Deadline: None Abstract: This rule finalizes the determination to establish a limitation on administrative expenses for Ryan White Comprehensive AIDS Resources Emergency (CARE) Act title IV Grants for Coordinated Services and Access to Research for Women, Infants, Children, and Youth. The rule establishes the limitation on administrative expenses as a percentage of the grant award, provides guidance on the procedures and processes for implementation of the limitation on administrative expenses, and clarifies the individual expenses that shall be categorized as administrative. The rule specifies the date for implementation as grants funded using fiscal year 2005 grant dollars. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 08/12/03 68 FR 47923 NPRM Comment Period End 09/11/03 Final Action 11/00/04 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Jose Rafael Morales, Acting Director, Division of Community Based Programs, Department of Health and Human Services, Health Resources and Services Administration, 5600 Fishers Lane, Room 7A-21, Rockville, MD 20857 Phone: 301 443-3650 Email: jmorales@hrsa.gov RIN: 0906-AA65 [[Page 73155]] _______________________________________________________________________ Department of Health and Human Services (HHS) Long-Term Actions Health Resources and Services Administration (HRSA) _______________________________________________________________________ 1010. NATIONAL PRACTITIONER DATA BANK FOR ADVERSE INFORMATION ON PHYSICIANS AND OTHER HEALTH CARE PRACTITIONERS: REPORTING ADVERSE AND NEGATIVE ACTIONS Priority: Substantive, Nonsignificant Legal Authority: 42 USC 1396r-2 CFR Citation: 45 CFR 60 Legal Deadline: None Abstract: Public Law 100-93 amended section 1921 of the Social Security Act to require that each State have in effect a system of reporting disciplinary licensure actions taken against all licensed health care practitioners and entities. It also requires States to report any negative action or finding that a peer review organization, private accreditation entity, or a State has concluded against a health care practitioner or entity. Section 1921 directs the Secretary to provide for maximum appropriate coordination in the implementation of these reporting requirements with those of the Health Care Quality Improvement Act of 1986 (title IV of Pub. L. 99-660). Section 1921 requirements will be incorporated into the National Practitioner Data Bank. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM To Be Determined Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: State Agency Contact: Mark S. Pincus, Director, Division of Practitioner Data Banks, Department of Health and Human Services, Health Resources and Services Administration, Suite 300, 7519 Standish Place, Rockville, MD 20857 Phone: 301 443-2300 RIN: 0906-AA57 _______________________________________________________________________ 1011. OPERATION OF THE ORGAN PROCUREMENT AND TRANSPLANTATION NETWORK (OPTN) Priority: Other Significant. Major status under 5 USC 801 is undetermined. Legal Authority: 42 USC 274e, sec 301, 1984; 42 USC 273 to 274d, sec 371 to 376; 42 USC 1320b-8, sec 1138 CFR Citation: 42 CFR 121 Legal Deadline: None Abstract: The Department of Health and Human Services (HHS) proposes to amend the final rule governing the operation of the OPTN. This notice of proposed rulemaking provides the legislative and regulatory history of the current rule, the factors that persuaded HHS of the advisability of amending the final rule governing the operation of the OPTN, and the anticipated consequences of this proposal. As required rapid changes in response to better understanding of the clinical scientific issues have become evident, HHS has determined that the current process for approving and enforcing policies must be amended. Timetable: Next Action Undetermined Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Dr. Hui--Hsing Wong, Medical Officer, Department of Health and Human Services, Health Resources and Services Administration, 5600 Fishers Lane, Mail Stop 16C-17, Parklawn Bldg., Rockville, MD 20857 Phone: 301 443-8104 Fax: 301 594 6095 Email: hwong@hrsa.gov RIN: 0906-AA63 _______________________________________________________________________ Department of Health and Human Services (HHS) Completed Actions Health Resources and Services Administration (HRSA) _______________________________________________________________________ 1012. LIABILITY PROTECTION FOR CERTAIN FREE CLINIC HEALTH PROFESSIONALS Priority: Substantive, Nonsignificant. Major status under 5 USC 801 is undetermined. CFR Citation: Not Yet Determined Completed: ________________________________________________________________________ Reason Date FR Cite ________________________________________________________________________ Withdrawn 09/29/04 Regulatory Flexibility Analysis Required: No Government Levels Affected: None Agency Contact: Felicia Collins Phone: 301 594-0818 Fax: 301 594 5224 RIN: 0906-AA67 _______________________________________________________________________ Department of Health and Human Services (HHS) Proposed Rule Stage National Institutes of Health (NIH) _______________________________________________________________________ 1013. UNDERGRADUATE SCHOLARSHIP PROGRAM REGARDING PROFESSIONS NEEDED BY THE NATIONAL INSTITUTES OF HEALTH (NIH) Priority: Substantive, Nonsignificant Legal Authority: 42 USC 216; 42 USC 288-4 CFR Citation: 42 CFR 68b Legal Deadline: None Abstract: Section 487D of the Public Health Service Act, as added by the National Institutes of Health Revitalization Act of 1993, creates a program offering scholarships, in an amount not to exceed $20,000 per year of academic study, to individuals from disadvantaged backgrounds who are enrolled as full-time students at accredited institutions pursuing academic programs appropriate for careers in professions needed by NIH. For each year of scholarship support, the recipient agrees to service (employment) after graduation, at NIH, for one year. Additionally, the individual agrees to at least 10 consecutive weeks of service (employment) at NIH during which the [[Page 73156]] individual is attending the educational institution and receiving the NIH scholarship. The proposed new regulations will cover this program. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 04/00/05 Regulatory Flexibility Analysis Required: No Government Levels Affected: None Agency Contact: Jerry Moore, NIH Regulations Officer, Department of Health and Human Services, National Institutes of Health, Room 601 MSC 7669, 6011 Executive Boulevard, Rockville, MD 20852 Phone: 301 496-4606 Fax: 301 402-0169 Email: jm40z@nih.gov RIN: 0925-AA10 _______________________________________________________________________ 1014. NATIONAL INSTITUTES OF HEALTH TRAINING GRANTS Priority: Substantive, Nonsignificant Legal Authority: 42 USC 216; 42 USC 285g-10 CFR Citation: 42 CFR 63a Legal Deadline: None Abstract: NIH proposes to amend the training grants regulations to implement the new authority under section 452G of the Public Health Service (PHS) Act. This action is necessitated by enactment of the Children's Act of 2000. Section 1002 of this Act adds a new section 452G to the PHS Act that authorizes the Director of the National Institute of Child Health and Human Development, in consultation with the Administrator of the Health Resources and Services Administration, to support activities to provide for an increase in the number and size of institutional training grants supporting pediatric training. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 04/00/05 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Jerry Moore, NIH Regulations Officer, Department of Health and Human Services, National Institutes of Health, Room 601 MSC 7669, 6011 Executive Boulevard, Rockville, MD 20852 Phone: 301 496-4606 Fax: 301 402-0169 Email: jm40z@nih.gov RIN: 0925-AA28 _______________________________________________________________________ 1015. STANDARDS FOR A NATIONAL CHIMPANZEE SANCTUARY SYSTEM Priority: Substantive, Nonsignificant Legal Authority: 42 USC 287a-3a CFR Citation: 42 CFR 9 Legal Deadline: NPRM, Statutory, June 18, 2001. Abstract: NIH proposes to establish standards for operating a national chimpanzee sanctuary system to provide for the retirement of federally- owned or supported chimpanzees no longer needed for research. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 01/00/05 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Jerry Moore, NIH Regulations Officer, Department of Health and Human Services, National Institutes of Health, Room 601 MSC 7669, 6011 Executive Boulevard, Rockville, MD 20852 Phone: 301 496-4606 Fax: 301 402-0169 Email: jm40z@nih.gov RIN: 0925-AA31 _______________________________________________________________________ 1016. NATIONAL INSTITUTES OF HEALTH AIDS RESEARCH LOAN REPAYMENT PROGRAM Priority: Substantive, Nonsignificant Unfunded Mandates: Undetermined Legal Authority: 42 USC 216; 42 USC 288-1 CFR Citation: 42 CFR 68 Legal Deadline: None Abstract: Section 487A of the Public Health Service Act creates a program through which appropriately qualified health professionals may obtain federally funded repayment of educational loans by conducting AIDS research as NIH employees. NIH is issuing regulations that will govern the program. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 02/00/05 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Jerry Moore, NIH Regulations Officer, Department of Health and Human Services, National Institutes of Health, Room 601 MSC 7669, 6011 Executive Boulevard, Rockville, MD 20852 Phone: 301 496-4606 Fax: 301 402-0169 Email: jm40z@nih.gov RIN: 0925-AA32 _______________________________________________________________________ 1017. NATIONAL INSTITUTES OF HEALTH EXTRAMURAL LOAN REPAYMENT PROGRAM FOR CLINICAL RESEARCHERS Priority: Substantive, Nonsignificant Legal Authority: 42 USC 216; 42 USC 288-5a CFR Citation: 42 CFR 68g Legal Deadline: None Abstract: NIH proposes to establish implementing regulations for the Extramural Loan Repayment Program for Clinical Researchers, authorized under section 487F of the Public Health Service Act. The program provides for the repayment of the existing educational loan debt of qualified health professionals who agree to conduct clinical research. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 03/00/05 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Jerry Moore, NIH Regulations Officer, Department of Health and Human Services, National Institutes of Health, Room 601 MSC 7669, 6011 Executive Boulevard, Rockville, MD 20852 Phone: 301 496-4606 Fax: 301 402-0169 Email: jm40z@nih.gov RIN: 0925-AA33 [[Page 73157]] _______________________________________________________________________ 1018. NATIONAL INSTITUTES OF HEALTH PEDIATRIC RESEARCH LOAN REPAYMENT PROGRAM Priority: Substantive, Nonsignificant Legal Authority: 42 USC 216; 42 USC 288-6 CFR Citation: 42 CFR 68e Legal Deadline: None Abstract: NIH proposes to establish implementing regulations for Pediatric Research Loan Repayment Program, authorized under section 487F of the Public Health Service Act. The program provides for the repayment of the existing educational loan debt of qualified health professionals who agree to conduct pediatric research. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 04/00/05 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Jerry Moore, NIH Regulations Officer, Department of Health and Human Services, National Institutes of Health, Room 601 MSC 7669, 6011 Executive Boulevard, Rockville, MD 20852 Phone: 301 496-4606 Fax: 301 402-0169 Email: jm40z@nih.gov RIN: 0925-AA34 _______________________________________________________________________ 1019. NATIONAL INSTITUTES OF HEALTH LOAN REPAYMENT PROGRAM FOR HEALTH DISPARITIES RESEARCH Priority: Substantive, Nonsignificant Legal Authority: 42 USC 216; 42 USC 287c-33 CFR Citation: 42 CFR 68f Legal Deadline: None Abstract: NIH proposes to establish implementing regulations for the Loan Repayment Program for Health Disparities Research, authorized under section 485G of the Public Health Service Act. The program provides for the repayment of the existing educational loan debt of qualified health professionals who agree to conduct minority-health or other health-disparities research for a minimum of two years. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 04/00/05 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Jerry Moore, NIH Regulations Officer, Department of Health and Human Services, National Institutes of Health, Room 601 MSC 7669, 6011 Executive Boulevard, Rockville, MD 20852 Phone: 301 496-4606 Fax: 301 402-0169 Email: jm40z@nih.gov RIN: 0925-AA35 _______________________________________________________________________ 1020. NATIONAL INSTITUTES OF HEALTH CLINICAL RESEARCH LOAN REPAYMENT PROGRAM FOR INDIVIDUALS FROM DISADVANTAGED BACKGROUNDS Priority: Substantive, Nonsignificant Legal Authority: 42 USC 216; 42 USC 288-5 CFR Citation: 42 CFR 68a Legal Deadline: None Abstract: NIH proposes to amend the regulations governing the Clinical Research Loan Repayment Program for Individuals from Disadvantaged Backgrounds to reflect the new maximum annual loan amount of $35,000 and a change in program eligibility to include qualified health professionals who are not NIH employees, as well as to amend the definition of ``disadvantaged.'' Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 04/00/05 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Jerry Moore, NIH Regulations Officer, Department of Health and Human Services, National Institutes of Health, Room 601 MSC 7669, 6011 Executive Boulevard, Rockville, MD 20852 Phone: 301 496-4606 Fax: 301 402-0169 Email: jm40z@nih.gov RIN: 0925-AA36 _______________________________________________________________________ 1021. NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT CONTRACEPTION AND INFERTILITY RESEARCH LOAN REPAYMENT PROGRAM Priority: Substantive, Nonsignificant. Major status under 5 USC 801 is undetermined. Legal Authority: 42 USC 216; 42 USC 288-2 CFR Citation: 42 CFR 68c Legal Deadline: None Abstract: NIH proposes to amend its current regulations governing the National Institute of Child Health and Human Development Contraception and Infertility Research Loan Repayment Program to make the eligibility requirements of the Program consistent with the eligibility requirements of the other extramural loan repayment programs administered by NIH. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 01/00/05 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Jerry Moore, NIH Regulations Officer, Department of Health and Human Services, National Institutes of Health, Room 601 MSC 7669, 6011 Executive Boulevard, Rockville, MD 20852 Phone: 301 496-4606 Fax: 301 402-0169 Email: jm40z@nih.gov RIN: 0925-AA41 [[Page 73158]] _______________________________________________________________________ Department of Health and Human Services (HHS) Final Rule Stage National Institutes of Health (NIH) _______________________________________________________________________ 1022. NATIONAL INSTITUTES OF HEALTH LOAN REPAYMENT PROGRAM FOR RESEARCH GENERALLY Priority: Substantive, Nonsignificant Legal Authority: 42 USC 216; 42 USC 288-3 CFR Citation: 42 CFR 68d Legal Deadline: None Abstract: Regulations will be issued to govern the awarding of educational loan repayments to qualified health professionals who agree to conduct research as employees of the National Institutes of Health. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 08/05/02 67 FR 50622 Final Action 04/00/05 Regulatory Flexibility Analysis Required: No Government Levels Affected: None Agency Contact: Jerry Moore, NIH Regulations Officer, Department of Health and Human Services, National Institutes of Health, Room 601 MSC 7669, 6011 Executive Boulevard, Rockville, MD 20852 Phone: 301 496-4606 Fax: 301 402-0169 Email: jm40z@nih.gov RIN: 0925-AA18 _______________________________________________________________________ Department of Health and Human Services (HHS) Completed Actions National Institutes of Health (NIH) _______________________________________________________________________ 1023. NATIONAL INSTITUTES OF HEALTH CENTER GRANTS Priority: Substantive, Nonsignificant CFR Citation: 42 CFR 52a Completed: ________________________________________________________________________ Reason Date FR Cite ________________________________________________________________________ Final Action 12/15/03 68 FR 6961 Regulatory Flexibility Analysis Required: No Small Entities Affected: Governmental Jurisdictions Government Levels Affected: None Agency Contact: Jerry Moore Phone: 301 496-4606 Fax: 301 402-0169 Email: jm40z@nih.gov RIN: 0925-AA24 _______________________________________________________________________ Department of Health and Human Services (HHS) Prerule Stage Office of Public Health and Science (OPHS) _______________________________________________________________________ 1024. HUMAN SUBJECTS PROTECTION REGULATIONS: ADDITIONAL PROTECTIONS FOR ADULT INDIVIDUALS WITH IMPAIRED DECISIONMAKING CAPACITY Priority: Substantive, Nonsignificant. Major status under 5 USC 801 is undetermined. Legal Authority: 5 USC 301; 42 USC 289 CFR Citation: 45 CFR 46 Legal Deadline: None Abstract: Through this advance notice of proposed rulemaking (ANPRM), the Office for Human Research Protections (OHRP), Office of Public Health and Science, and the Food and Drug Administration (FDA) of the Department of Health and Human Services (HHS) are seeking comment on whether it is necessary to develop additional safeguards to help protect adult individuals with impaired decisionmaking capacity who are potential subjects in research, and if so, suggestions for appropriate safeguards. This ANPRM stems from the recommendation of an HHS working group, generated in response to the report published by the National Bioethics Advisory Commission entitled ``Research Involving Persons with Mental Disorders That May Affect Decisionmaking Capacity'' (December 1998), and from subsequent recommendations by the Nation Human Research Protections Advisory Committee. The goal of these efforts is to maximize the safety and welfare of adult subjects with impaired decisionmaking capacity who participate in research supported, conducted, or regulated by HHS. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ ANPRM 03/00/05 ANPRM Comment Period End 09/00/05 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Julie A. Kaneshiro, Policy Team Leader, Office for Human Research Protections, Department of Health and Human Services, Office of Public Health and Science, 1101 Wootton Parkway, Suite 200, Rockville, MD 20852 Phone: 301 496-7005 Fax: 301 402-2071 Email: jakaneshiro@ophs.dhhs.gov RIN: 0940-AA11 [[Page 73159]] _______________________________________________________________________ Department of Health and Human Services (HHS) Final Rule Stage Office of Public Health and Science (OPHS) _______________________________________________________________________ 1025. PUBLIC HEALTH SERVICE STANDARDS FOR THE PROTECTION OF RESEARCH MISCONDUCT WHISTLEBLOWERS Priority: Substantive, Nonsignificant Legal Authority: 42 USC 216; 42 USC 241; 42 USC 289b CFR Citation: 42 CFR 94 Legal Deadline: None Abstract: To implement section 493(e) of the Public Health Service Act (added by section 163 of the National Institutes of Health Revitalization Act of 1993, Pub. L. 103-43), the Department is proposing to add a new part 94 to title 42 of the Code of Federal Regulations. Under this proposed regulation, covered institutions must follow certain requirements for preventing and responding to occurrences of retaliation against whistleblowers. The purpose of this part is to protect: 1) persons who make a good faith allegation that a covered institution or member thereof engaged in, or failed to respond adequately to an allegation of research misconduct; and 2) persons who cooperate in good faith with an investigation of research misconduct. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 11/28/00 65 FR 70830 NPRM Comment Period End 01/29/01 Final Action 02/00/05 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Chris Pascal, Director, Office of Research Integrity, Department of Health and Human Services, Office of Public Health and Science, Suite 750, 1101 Wootten Parkway, Rockville, MD 20852 Phone: 301 443-3400 Fax: 301 443-5351 Related RIN: Related to 0940-AA04 RIN: 0940-AA01 _______________________________________________________________________ 1026. PUBLIC HEALTH SERVICE POLICIES ON RESEARCH MISCONDUCT Priority: Substantive, Nonsignificant Legal Authority: 42 USC 216; 42 USC 241; 42 USC 289b CFR Citation: 42 CFR 93 Legal Deadline: None Abstract: This notice of proposed rulemaking proposes substantial revisions to the existing regulations at 42 CFR part 50, subpart A, ``Responsibilities of Awardee and Applicant Institutions for Dealing With and Reporting Possible Misconduct in Science,'' 54 FR 32449, August 8, 1989. The National Institutes of Health Revitalization Act of 1993 (NIH Act), Public Law 103-43, contains provisions that affect the current rule. For example, section 161 of the NIH Act established the Office of Research Integrity (ORI) as an independent entity reporting to the Secretary, and recent organizational changes have also affected the ORI's operations. In addition, the Office of Science and Technology Policy (OSTP) published a Governmentwide policy that applies to federally-funded research and proposals submitted to the Federal agencies for research funding, 65 FR 76260, December 6, 2000. The proposed revised regulation will implement this OSTP policy, which contains a definition of research misconduct and basic guidelines for the response of Federal agencies and research institutions to allegations of research misconduct. The current regulation, which implemented section 493(e) of the Public Health Service Act, would be deleted, and a new part 93, subparts A, B, C, D, and E would be added. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 04/16/04 69 FR 20778 NPRM Comment Period End 06/15/04 Final Action 05/00/05 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Chris Pascal, Director, Office of Research Integrity, Department of Health and Human Services, Office of Public Health and Science, Suite 750, 1101 Wootten Parkway, Rockville, MD 20852 Phone: 301 443-3400 Fax: 301 443-5351 Related RIN: Related to 0940-AA01 RIN: 0940-AA04 _______________________________________________________________________ 1027. HUMAN SUBJECTS PROTECTION REGULATIONS: INSTITUTIONAL REVIEW BOARDS REGISTRATION REQUIREMENTS Priority: Substantive, Nonsignificant Legal Authority: 5 USC 301; 42 USC 289 CFR Citation: 45 CFR 46 Legal Deadline: None Abstract: This notice of proposed rulemaking proposes to add subpart F to Department of Health and Human Services (HHS) regulations for protection of human subjects, 45 CFR part 46, to require registration of institutional review boards (IRBs) with HHS. The registration information would include contact information, approximate numbers of active protocols involving research conducted or supported by HHS, accreditation status, IRB membership, and staffing for the IRB. The proposed registration requirements will make it easier for the Office for Human Research Protections (OHRP) to convey information to IRBs, and will support the current IRB registration operated by OHRP. Under the current OHRP IRB registration system, the submission of certain registration information is required by human subjects protection regulations, and certain other information may be submitted voluntarily. This proposed information collection was submitted to the Office of Management and Budget under the Paperwork Reduction Act. Under the proposed rule, all registration information will be required, making the IRB registration system uniform with IRB registration requirements of the Food and Drug Administration (FDA), and creating a single, HHS IRB Registration system. FDA simultaneously published a proposed rule regarding FDA IRB registration requirements. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 07/04/04 69 FR 40584 NPRM Comment Period End 10/04/04 Final Action 04/00/05 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Irene Stith-Coleman Ph.D, Department of Health and Human Services, Office of Public Health and [[Page 73160]] Science, Suite 200, The Tower Building, 1101 Wootten Parkway, Rockville, MD 20852 Phone: 301 496-7005 Fax: 301 402-0527 RIN: 0940-AA06 _______________________________________________________________________ 1028. FEDERAL POLICY FOR THE PROTECTION OF HUMAN SUBJECTS TECHNICAL AMENDMENT Priority: Substantive, Nonsignificant Legal Authority: 5 USC 301; 42 USC 289; 42 USC 300v-1(b) CFR Citation: 45 CFR 46 Legal Deadline: None Abstract: This final rule amends the Department of Health and Human Services (HHS) regulations for the protection of human subjects by changing all references to the Office for Protection from Research Risks (OPRR) to the Office for Human Research Protections (OHRP) and revising the footnote at the end of 45 CFR 46.101(i) by deleting the references to research involving fetuses, pregnant women, or human in vitro fertilization and subpart B of 45 CFR part 46. This technical amendment is being made in conjunction with the other federal departments and agencies that have promulgated the Federal Policy for the Protection of Human Subjects. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Final Action 12/00/04 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Michael A. Carome MD, Department of Health and Human Services, Office of Public Health and Science, Suite 200, The Tower Building, Suite 200, 1101 Wootten Parkway, Rockville, MD 20852 Phone: 301 496-7005 Fax: 301 402-0527 RIN: 0940-AA10 _______________________________________________________________________ Department of Health and Human Services (HHS) Long-Term Actions Office of Public Health and Science (OPHS) _______________________________________________________________________ 1029. HUMAN SUBJECTS PROTECTION REGS.: TRAINING AND EDUCATION REQUIREMENTS FOR INSTITUTIONAL OFFICIALS, INSTITUTIONAL REVIEW BOARD MEMBERS AND STAFF, HUMAN PROTECTIONS ADMINISTRATORS, AND INVESTIGATORS Priority: Other Significant. Major status under 5 USC 801 is undetermined. Legal Authority: 5 USC 301; 42 USC 289 CFR Citation: 45 CFR 46 Legal Deadline: None Abstract: This notice of proposed rulemaking proposes to add subpart E to the Department of Health and Human Services (HHS) regulations for protection of human subjects, 45 CFR part 46, and would require that institutions engaged in human subjects research covered by an assurance of compliance filed with the Office for Human Research Protections ensure that institutional officials, institutional review board (IRB) chairpersons, and human protection administrators receive appropriate training and education about the institution's assurance and that IRB chairpersons and members, IRB staff, investigators, and other personnel involved in the conduct or oversight of human subjects research receive appropriate training and education about relevant human subjects protection requirements. The proposed training and education requirements will help to ensure that responsible individuals at assured institutions understand and meet their regulatory responsibilities for human subjects protection. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM To Be Determined Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Michael A. Carome MD, Department of Health and Human Services, Office of Public Health and Science, Suite 200, The Tower Building, Suite 200, 1101 Wootten Parkway, Rockville, MD 20852 Phone: 301 496-7005 Fax: 301 402-0527 RIN: 0940-AA08 _______________________________________________________________________ Department of Health and Human Services (HHS) Proposed Rule Stage Centers for Medicare & Medicaid Services (CMS) _______________________________________________________________________ 1030. HOME HEALTH AGENCY (HHA) CONDITIONS OF PARTICIPATION (COPS) (CMS- 3819-P) Priority: Other Significant Legal Authority: 42 USC 1302; 42 USC 1395x; 42 USC 1395cc(a); 42 USC 1395hh; 42 USC 1395bb CFR Citation: 42 CFR 484 Legal Deadline: None Abstract: This proposed rule would revise the existing CoPs that HHAs must meet to participate in the Medicare program. The requirements focus on the actual care delivered to patients by HHAs, reflect an interdisciplinary view of patient care, allow HHAs greater flexibility in meeting quality standards, and eliminate unnecessary procedural requirements. These changes are an integral part of the Administration's efforts to achieve broad-based improvements and measurements of the quality of care furnished through Federal programs while at the same time reducing procedural burdens on providers. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 03/10/97 62 FR 11005 NPRM Comment Period End 06/09/97 Second NPRM 05/00/05 Regulatory Flexibility Analysis Required: No [[Page 73161]] Small Entities Affected: Businesses, Organizations Government Levels Affected: None Agency Contact: Mercedes Benitez-McCray, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Office of Clinical Standards and Quality, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786-5716 Scott Cooper, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Office of Clinical Standards and Quality, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786-9465 RIN: 0938-AG81 _______________________________________________________________________ 1031. END STAGE RENAL DISEASE (ESRD) CONDITIONS FOR COVERAGE (CMS-3818- P) (SECTION 610 REVIEW) Regulatory Plan: This entry is Seq. No. 60 in part II of this issue of the Federal Register. RIN: 0938-AG82 _______________________________________________________________________ 1032. HOSPITAL CONDITIONS OF PARTICIPATION: REQUIREMENTS FOR APPROVAL AND REAPPROVAL OF TRANSPLANT CENTERS TO PERFORM ORGAN TRANSPLANTS (CMS- 3835-P) Regulatory Plan: This entry is Seq. No. 61 in part II of this issue of the Federal Register. RIN: 0938-AH17 _______________________________________________________________________ 1033. HOSPICE CARE--CONDITIONS OF PARTICIPATION (CMS-3844-P) Regulatory Plan: This entry is Seq. No. 62 in part II of this issue of the Federal Register. RIN: 0938-AH27 _______________________________________________________________________ 1034. STANDARD UNIQUE NATIONAL HEALTH PLAN IDENTIFIERS (CMS-6017-P) Priority: Other Significant. Major under 5 USC 801. Unfunded Mandates: This action may affect State, local or tribal governments. Legal Authority: 42 USC 1320d to 1320d-8 CFR Citation: 45 CFR 160; 45 CFR 162 Legal Deadline: Final, Statutory, February 21, 1998. Abstract: This proposed rule would implement a standard identifier to identify health plans that process and pay certain electronic health care transactions. It would implement one of the requirements for administrative simplification that have a national scope beyond Medicare and Medicaid. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 04/00/05 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: State Federalism: This action may have federalism implications as defined in EO 13132. Agency Contact: Helen Dietrick, Department of Health and Human Services, Centers for Medicare & Medicaid Services, S1-07-17, Office of Information Services, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786-7448 RIN: 0938-AH87 _______________________________________________________________________ 1035. APPEALS OF CARRIER DETERMINATION THAT A SUPPLIER FAILS TO MEET THE REQUIREMENTS FOR MEDICARE BILLING PRIVILEGES (CMS-6003-P2) Priority: Substantive, Nonsignificant Legal Authority: 42 USC 1302; 42 USC 1395u(b)(3)(C); 42 USC 1395ff(b) CFR Citation: 42 CFR 405.874 Legal Deadline: None Abstract: This rule extends appeal rights to all suppliers whose enrollment applications for Medicare billing privileges are disallowed by a carrier or whose Medicare billing privileges are revoked, except for those suppliers covered under other existing appeals provisions of our regulations. In addition, certain appeal provisions are revised to correspond with the existing appeal provisions in those other sections of our regulations. The rule also extends appeal rights to all suppliers not covered by existing regulations to ensure they have a full and fair opportunity to be heard. This rule will incorporate provisions from section 936 of the Medicare Modernization Act (MMA). Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 10/25/99 64 FR 57431 Second NPRM 02/00/05 Regulatory Flexibility Analysis Required: No Small Entities Affected: Businesses Government Levels Affected: None Agency Contact: Ralph Goldberg, Division of Provider and Supplier Enrollment, Department of Health and Human Services, Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786-4870 RIN: 0938-AI49 _______________________________________________________________________ 1036. RURAL HEALTH CLINICS: AMENDMENTS TO PARTICIPATION REQUIREMENTS AND PAYMENT PROVISIONS AND ESTABLISHMENT OF A QUALITY ASSESSMENT AND IMPROVEMENT PROGRAM (CMS-1910-P2) Priority: Other Significant Legal Authority: 42 USC 1302; 42 USC 1395hh CFR Citation: 42 CFR 405; 42 CFR 491 Legal Deadline: None Abstract: This rule amends the Medicare certification and payment requirements for rural health clinics (RHCs), as required by section 4205 of the Balanced Budget Act of 1997. It changes the definition of a qualifying rural shortage area in which a Medicare RHC must be located; establishes criteria for identifying RHCs essential to delivery of primary care services that we can continue to approve as Medicare RHCs in areas no longer designated as medically underserved; and limits nonphysician practitioner staffing requirements. This rule imposes payment limits on provider-based RHCs and prohibits the use of RHC space, professional staff, equipment, and other RHC resources by another Medicare entity. The rule also requires RHCs to establish a quality assessment and performance improvement program. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 12/24/03 68 FR 74792 Second NPRM 02/00/05 Regulatory Flexibility Analysis Required: No [[Page 73162]] Small Entities Affected: Businesses Government Levels Affected: Federal Agency Contact: David Worgo, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, C4-15-18, Center for Medicare Management, 7500 Security Boulevard, C4- 15-18, Baltimore, MD 21244 Phone: 410 786-5919 RIN: 0938-AJ17 _______________________________________________________________________ 1037. SUPPLIER STANDARDS FOR HOME OXYGEN, THERAPEUTIC SHOES, AND HOME NUTRITION THERAPY (CMS-6010-P) Priority: Substantive, Nonsignificant Legal Authority: Not Yet Determined CFR Citation: 42 CFR 424.57 Legal Deadline: None Abstract: This proposed rule would implement certain provisions in the statute relating to suppliers of durable medical equipment, prosthetics, orthotics, and supplies and establish service standards for suppliers of home oxygen equipment and therapeutic shoes home nutrition therapy. Establishing these standards would ensure that suppliers are qualified to provide the appropriate health care services and help safeguard the Medicare program and its beneficiaries from any instances of fraudulent or abusive billing practices. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 01/00/05 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: None Agency Contact: Ralph Goldberg, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, C3-02-16, Center for Medicaid and State Operations, 7500 Security Boulevard, C3-02-16, Baltimore, MD 21244 Phone: 410 786-4870 RIN: 0938-AJ98 _______________________________________________________________________ 1038. STANDARDS FOR ELECTRONIC HEALTH CARE CLAIM ATTACHMENTS(CMS-0050-P) Priority: Economically Significant. Major under 5 USC 801. Unfunded Mandates: This action may affect State, local or tribal governments. Legal Authority: 42 USC 1320d-2(a)(2)(B) CFR Citation: 45 CFR 162 Legal Deadline: Final, Statutory, August 21, 1998. Abstract: This rule proposes an electronic standard for claims attachments. The standard is required by the Health Insurance Portability and Accountability Act of 1996. It would be used to transmit clinical data, in addition to the data contained in the claims standard, to help establish medical necessity for coverage and payment. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 01/00/05 Regulatory Flexibility Analysis Required: No Small Entities Affected: Businesses Government Levels Affected: Federal, Local, State, Tribal Federalism: This action may have federalism implications as defined in EO 13132. Agency Contact: Lorraine Doo, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Office of Health Insurance Portability and Accountability Act Standards, S2-25-17, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786-6597 RIN: 0938-AK62 _______________________________________________________________________ 1039. ORGAN PROCUREMENT ORGANIZATION CONDITIONS FOR COVERAGE (CMS-3064- P) Regulatory Plan: This entry is Seq. No. 63 in part II of this issue of the Federal Register. RIN: 0938-AK81 _______________________________________________________________________ 1040. USE OF RESTRAINT AND SECLUSION IN MEDICARE AND MEDICAID PARTICIPATING FACILITIES THAT PROVIDE INPATIENT OR RESIDENTIAL CARE (CMS-2130-P) Regulatory Plan: This entry is Seq. No. 64 in part II of this issue of the Federal Register. RIN: 0938-AL26 _______________________________________________________________________ 1041. REVISIONS TO CONDITIONS FOR COVERAGE FOR AMBULATORY SURGICAL CENTERS (CMS-3887-P) Priority: Other Significant. Major under 5 USC 801. Unfunded Mandates: Undetermined Legal Authority: Not Yet Determined CFR Citation: None Legal Deadline: None Abstract: This proposed rule would revise the ambulatory surgical center conditions for coverage to reflect current innovations in healthcare delivery, quality assessment, and performance improvement. The focus would be to improve outcomes of health care and satisfaction for Medicare beneficiaries, while streamlining structural and procedural requirements when possible. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 09/00/05 Regulatory Flexibility Analysis Required: No Small Entities Affected: Businesses Government Levels Affected: State Agency Contact: Joan Brooks, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Office of Clinical Standards and Quality, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786-5526 Jacqueline Morgan, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, S3-02-01, Office of Clinical Standards and Quality, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786-4282 RIN: 0938-AL80 [[Page 73163]] _______________________________________________________________________ 1042. HEALTH COVERAGE PORTABILITY: TOLLING CERTAIN TIME PERIODS AND INTERACTIONS WITH FAMILY AND MEDICAL LEAVE ACT (CMS-2158-P) Priority: Other Significant Legal Authority: 42 USC 300gg; PL 104-191 CFR Citation: 45 CFR 146.113; 45 CFR 146.115; 45 CFR 146.117; 45 CFR 146.120; 45 CFR 146.145 Legal Deadline: None Abstract: This proposed rule would clarify certain portability requirements for group health plans and issuers of health insurance coverage offered in connection with a group health plan. It would also implement changes made to the Internal Revenue Code, the Employee Retirement Income Security Act, and the Public Health Service Act enacted as part of the Health Insurance Portability and Accountability Act of 1996. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 11/00/04 Regulatory Flexibility Analysis Required: No Small Entities Affected: Businesses, Organizations Government Levels Affected: Federal, Local, State Federalism: This action may have federalism implications as defined in EO 13132. Agency Contact: David Mlawsky, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, S3-16-26, Center for Medicaid and State Operations, 7500 Security Boulevard, S3-16-26, Baltimore, MD 21244 Phone: 410 786-6851 RIN: 0938-AL88 _______________________________________________________________________ 1043. MODIFICATIONS TO ELECTRONIC TRANSACTIONS AND CODE SETS (CMS-0009- P) Priority: Other Significant. Major status under 5 USC 801 is undetermined. Unfunded Mandates: Undetermined Legal Authority: Sec 1171 to 1179 of the Social Security Act CFR Citation: 42 CFR 162.1002; 42 CFR 162.1802 Legal Deadline: None Abstract: This proposed rule would revise the electronic transactions and code set standards mandated by the Health Insurance Portability and Accountability Act of 1966. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 06/00/05 Regulatory Flexibility Analysis Required: Undetermined Small Entities Affected: Businesses, Governmental Jurisdictions, Organizations Government Levels Affected: Federal, Local, State, Tribal Federalism: This action may have federalism implications as defined in EO 13132. Agency Contact: Gladys C. Wheeler, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786-0273 RIN: 0938-AM50 _______________________________________________________________________ 1044. REQUIREMENTS FOR LONG-TERM CARE FACILITIES: HOSPICE SERVICES (CMS- 3140-P) Priority: Economically Significant. Major status under 5 USC 801 is undetermined. Unfunded Mandates: Undetermined Legal Authority: 42 USC 1395i-3; 42 USC 1396r CFR Citation: 42 CFR 483 Legal Deadline: None Abstract: This proposed rule would establish requirements for hospice services that long term care (LTC) facilities must meet to participate in the Medicare and Medicaid programs. We are proposing this new requirement to ensure that quality hospice care is provided to eligible residents. This proposed rule is intended to assist in meeting the Administration's goals for broad-based improvements in the quality of health care furnished through the Medicare and Medicaid programs. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 06/00/05 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: Undetermined Federalism: Undetermined Agency Contact: Anita Panicker, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Office of Clinical Standards and Quality, 7500 Security Boulevard, S3- 04-26, Baltimore, MD 21244 Phone: 410 786-5646 RIN: 0938-AM87 _______________________________________________________________________ 1045. HOSPITAL CONDITIONS OF PARTICIPATION: REQUIREMENTS FOR HISTORY AND PHYSICAL EXAMINATIONS; AUTHENTICATION OF VERBAL ORDERS; SECURING MEDICATIONS; AND POST-ANESTHESIA EVALUATIONS (CMS-3122-P) Priority: Economically Significant. Major status under 5 USC 801 is undetermined. Legal Authority: 42 USC 1395x; 42 USC 1396d; 42 USC 1395bb CFR Citation: 42 CFR 482 Legal Deadline: None Abstract: This proposed rule would revise four of the conditions of participation that hospitals must meet to participate in the Medicare and Medicaid programs to decrease the burden on hospitals and allow hospitals to conform to current standards of practice. They must establish and maintain policies and procedures that ensure that the hospital meets these requirements by using standard practices related to history and physical examinations, verbal orders securing of medications, and completion of the post-anesthesia evaluation. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 02/00/05 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Organizations Government Levels Affected: None Additional Information: Decreases burden for hospitals and clinicaians. Agency Contact: Patricia Chmielewski, Health Insurance Specialist, [[Page 73164]] Department of Health and Human Services, Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786-6899 Email: pchmielewski@cms.hhs.gov RIN: 0938-AM88 _______________________________________________________________________ 1046. PHYSICIAN REFERRAL FOR NUCLEAR MEDICINE SERVICES AND SUPPLIES (CMS-1261-P) Priority: Other Significant. Major status under 5 USC 801 is undetermined. Unfunded Mandates: Undetermined Legal Authority: Sec 1877 of the Social Security Act CFR Citation: 42 CFR 411.351 Legal Deadline: None Abstract: This proposed rule would amend the definitions of ``radiology and certain other imaging services'' and ``radiation therapy services and supplies'' to include diagnostic and therapeutic nuclear medicine services and supplies, respectively. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 09/00/05 Regulatory Flexibility Analysis Required: No Small Entities Affected: Businesses Government Levels Affected: None Agency Contact: Joanne Sinsheimer, Center for Medicare Management, Department of Health and Human Services, Centers for Medicare & Medicaid Services, 7500 Security Boulevard, C4-25-02, Baltimore, MD 21244 Phone: 410 786-4620 Email: jsinsheimer@cms.hhs.gov RIN: 0938-AN04 _______________________________________________________________________ 1047. ENHANCED DSH TREATMENT FOR CERTAIN HOSPITALS (CMS-2198-P) Priority: Other Significant Unfunded Mandates: Undetermined Legal Authority: Section 1923(i) of the Social Security Act CFR Citation: Not Yet Determined Legal Deadline: None Abstract: This proposed rule would implement section 1001(d) of the Medicare Modernization Act which requires States to report additional information about their disproportionate share hospital (DSH) programs to their annual report. This section also requires States to independently audit and submit these certified audits annually to the Secretary beginning December 8, 2003. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 02/00/05 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: State Agency Contact: James Frizzera, Director, National Institutional Payment Policy Center for Medicaid and State Operations, Department of Health and Human Services, Centers for Medicare & Medicaid Services, 7500 Security Boulevard, S3-13-15, Baltimore, MD 21244 Phone: 410 786-3263 Email: jfrizzera@cms.hhs.gov RIN: 0938-AN09 _______________________________________________________________________ 1048. PRIOR DETERMINATION PROCESS FOR CERTAIN ITEMS AND SERVICES (CMS- 6024-P) Priority: Other Significant. Major under 5 USC 801. Unfunded Mandates: Undetermined Legal Authority: Sec 938 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 CFR Citation: Not Yet Determined Legal Deadline: Final, Statutory, June 8, 2005. Abstract: Section 938 of the Medicare Prescription Drug, Improvement, and Modernization Act requires that physicians and beneficiaries be able to receive a prior determination regarding coverage of certain items and physicians' services beginning June 8, 2005. (The final rule must be published by March 25, 2005.) Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 03/00/05 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Misty D. Whitaker, Health Insurance Specialist Office of Financial Management, Department of Health and Human Services, Centers for Medicare & Medicaid Services, 7500 Security Boulevard, C3- 02-16, Baltimore, MD 21244 Phone: 410 786-3087 Email: mwhitaker@cms.hhs.gov RIN: 0938-AN10 _______________________________________________________________________ 1049. COMPETITIVE ACQUISITION FOR CERTAIN DURABLE MEDICAL EQUIPMENT (DME), PROSTHETICS, ORTHOTICS, AND SUPPLIES (CMS-1270-P) Priority: Economically Significant. Major under 5 USC 801. Legal Authority: PL 108-173, MMA CFR Citation: 42 CFR 414.200; 42 CFR 405.502(g); 42 CFR 424.57; 42 CFR 410.38 Legal Deadline: NPRM, Statutory, April 1, 2005. Final, Statutory, May 1, 2006. Abstract: Section 302 of the Medicare Modernization Act establishes DME competitive bidding. National competitive bidding will provide a program for using market forces to set Medicare payment amounts. This will also create incentives for suppliers to provide quality items and services while at the same time providing Medicare with reasonable prices for payment. (The statute requires competitive bidding be implemented by January 1, 2007. Proposed and final rules must be published six months prior to implementation.) Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 06/00/05 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses, Governmental Jurisdictions, Organizations Government Levels Affected: Federal, State Agency Contact: Michael Keane, Health Policy Analyst, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Center for Medicare Management, 7500 Security Boulevard, C5-08-27, Baltimore, MD 21244 Phone: 410 786-4495 [[Page 73165]] Email: mkeane@cms.hhs.gov RIN: 0938-AN14 _______________________________________________________________________ 1050. UPDATE OF THE LIST OF COVERED PROCEDURES FOR AMBULATORY SURGICAL CENTERS FOR 2005 (CMS-1478-PN) Priority: Other Significant Legal Authority: Not Yet Determined CFR Citation: None Legal Deadline: NPRM, Statutory, July 1, 2005. Abstract: This proposed notice updates the list of Medicare-covered ASC procedures. (The subsequent final notice must be published by March 25, 2005, to be effective July 1, 2005.) Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 11/00/04 Regulatory Flexibility Analysis Required: Undetermined Government Levels Affected: None Agency Contact: Bob Cereghino, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Center for Medicare Management, 7500 Security Boulevard, C4-05-17, Baltimore, MD 21244 Phone: 410 786-4645 Email: bcereghino@cms.hhs.gov RIN: 0938-AN23 _______________________________________________________________________ 1051. REVISIONS TO HIPAA CODE SETS (CMS-0013-P) Priority: Economically Significant. Major under 5 USC 801. Unfunded Mandates: Undetermined Legal Authority: PL 104-191 CFR Citation: 45 CFR 162 Legal Deadline: None Abstract: This rule proposes revisions to the adopted transaction and code set standards detailed in regulations published by HHS on August 17, 2000, and February 20, 2003. The Secretary intends to propose any replacements for specific code sets. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 06/00/05 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses, Governmental Jurisdictions, Organizations Government Levels Affected: Federal, Local, State, Tribal Federalism: This action may have federalism implications as defined in EO 13132. Energy Effects: Statement of Energy Effects planned as required by Executive Order 13211. Agency Contact: Patricia Peyton, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Office of HIPAA Standards, S2-26-17, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786-1812 Email: ppeyton@cms.hhs.gov RIN: 0938-AN25 _______________________________________________________________________ 1052. PAYMENT FOR CLINICAL LABORATORY TESTS (CMS-1494-P) Priority: Substantive, Nonsignificant Legal Authority: Sec 1833(h)(8) of the MMA; Sec 416 of the MMA; PL 108- 173 CFR Citation: Not Yet Determined Legal Deadline: None Abstract: The Medicare Modernization Act of 2003 (MMA), Public Law 108- 173, requires codification of the payment basis for determining Medicare payments for new clinical laboratory tests under the clinical laboratory fee schedule. Also, section 416 of the MMA eliminates the application of the clinical laboratory fee schedule for hospital outpatient laboratory testing by a hospital with fewer than 50 beds in a qualified rural area for cost reporting periods beginning during the 2-year period beginning on July 1, 2004. Section 1833(h) of the Act mandates payment for outpatient clinical laboratory tests under a clinical laboratory fee schedule. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 02/00/05 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: None Agency Contact: Anita Greenberg, Health Insurance Specialist, CMS/CMM/ HAPG/DAS, Department of Health and Human Services, Centers for Medicare & Medicaid Services, 7500 Security Boulevard, C4-07-07, Baltimore, MD 21244 Phone: 410 786-4601 Email: agreenberg@cms.hhs.gov RIN: 0938-AN26 _______________________________________________________________________ 1053. PROSPECTIVE PAYMENT SYSTEM FOR LONG TERM CARE HOSPITALS: ANNUAL PAYMENT RATE UPDATES AND POLICY CHANGES FOR 2006 (CMS-1483-P) Priority: Economically Significant. Major under 5 USC 801. Legal Authority: Sec 123, PL 106-113; Sec 307(b), PL 106-554 CFR Citation: Not Yet Determined Legal Deadline: None Abstract: This rule proposes the payment rate update for the 2006 prospective payment system for Medicare long-term care hospitals. The new rates will be based on cost reports from the first LTC PPS rate year. The proposed and final rules must be published by April 29, 2005, to be effective July 1, 2005.) Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 01/00/05 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: None Agency Contact: Judy Richter, Health Insurance Specialist, CMS/CMM/ HAPG/DAC, Department of Health and Human Services, Centers for Medicare & Medicaid Services, 7500 Security Boulevard, C4-07-07, Baltimore, MD 21244 Phone: 410 786-2590 Email: jrichter@cms.hhs.gov RIN: 0938-AN28 _______________________________________________________________________ 1054. RANDOM PREPAYMENT REVIEW (CMS-6022-P) Priority: Other Significant. Major under 5 USC 801. Legal Authority: Sec 934 of the MMA CFR Citation: Not Yet Determined Legal Deadline: NPRM, Statutory, December 8, 2004. Abstract: This proposed rule would implement the statutory requirements [[Page 73166]] regarding the termination of non-random prepayment review under section 934 of the Medicare Modernization Act beginning December 8, 2004. This proposed rule would provide guidelines for terminating a provider of services or supplier from non-random payment review. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 03/00/05 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Federalism: Undetermined Agency Contact: Marie Casey, Health Insurance Specialist, CMS/OFM/PIG, Department of Health and Human Services, Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786-7861 Email: mcasey2@cms.hhs.gov RIN: 0938-AN31 _______________________________________________________________________ 1055. REPAYMENT PLANS AND LIMITATION ON RECOUPMENT OF OVERPAYMENTS (CMS-6025-P) Priority: Other Significant. Major status under 5 USC 801 is undetermined. Legal Authority: Section 935 of the MMA CFR Citation: None Legal Deadline: Final, Statutory, December 8, 2003. Abstract: This proposed rule would implement two provisions of Section 935 of the Medicare Modernization Act which added a new subsection to Section 1893 of the Social Security Act. It would establish criteria and procedures for a repayment plan where repaying a Medicare overpayment would be a hardship for a provider or supplier absent specific exceptions. It also would prohibit recoupment where a provider or supplier has appealed an overpayment determination until the reconsideration-level appeal is decided. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 09/00/05 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Lisa A. Vriezen, Director, Division of Medicare Overpayment, Financial Services Group, Office of Financial Management, Department of Health and Human Services, Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786-1492 Email: lvriezen@cms.hhs.gov RIN: 0938-AN42 _______________________________________________________________________ 1056. PROSPECTIVE PAYMENT SYSTEM FOR INPATIENT REHABILITATION FACILITIES FOR FY 2006 (CMS-1290-P) Priority: Other Significant. Major status under 5 USC 801 is undetermined. Unfunded Mandates: Undetermined Legal Authority: Sec 1886(l) of the Social Security Act; PL 105-33; PL 106-554; PL 106-113 CFR Citation: Not Yet Determined Legal Deadline: Final, Statutory, August 1, 2004, Rates for PPS. Abstract: The proposed rule would update rates for the prospective payment system for inpatient rehabilitation facilities for FY 2006. (The statute requires that this notice be published by August 1, 2005.) Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 04/00/05 Regulatory Flexibility Analysis Required: Undetermined Government Levels Affected: Undetermined Federalism: Undetermined Agency Contact: Robert Kuhl, Division Director, Department of Health and Human Services, Centers for Medicare & Medicaid Services, C4-11-06, Center for Medicare Management, 7500 Security Boulevard, C5-06-24, Baltimore, MD 21244 Phone: 410 786-4597 RIN: 0938-AN43 _______________________________________________________________________ 1057. HOME HEALTH PROSPECTIVE PAYMENT SYSTEM RATE UPDATE FOR CALENDAR YEAR 2006 (CMS-1301-P) Priority: Substantive, Nonsignificant. Major status under 5 USC 801 is undetermined. Legal Authority: Sec 1895 of the Social Security Act CFR Citation: Not Yet Determined Legal Deadline: None Abstract: This poposed rule would set forth an update to the 60-day national episode rates and the national per-visit amounts under the Medicare prospective payment system for home health agencies. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 05/00/05 Regulatory Flexibility Analysis Required: Undetermined Government Levels Affected: Undetermined Federalism: Undetermined Agency Contact: Randy Throndset, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Center for Medicare Management, 7500 Security Boulevard, C5-09-15, Baltimore, MD 21244 Phone: 410 786-0131 RIN: 0938-AN44 _______________________________________________________________________ 1058. CHANGES TO THE HOSPITAL OUTPATIENT PROSPECTIVE PAYMENT SYSTEM AND CALENDAR YEAR 2006 PAYMENT RATES (CMS-1501-P) Priority: Substantive, Nonsignificant. Major status under 5 USC 801 is undetermined. Legal Authority: BBA; BBRA; BIPA; MMA CFR Citation: Not Yet Determined Legal Deadline: None Abstract: The proposed rule would adjust payments under the Medicare hospital outpatient payment system beginning January 1. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 08/00/05 Regulatory Flexibility Analysis Required: Yes [[Page 73167]] Small Entities Affected: Businesses Government Levels Affected: Federal Federalism: This action may have federalism implications as defined in EO 13132. Agency Contact: Dana Buley, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Baltmore, MD 21244 Phone: 410 786-4547 Email: dbuley@cms.hhs.gov RIN: 0938-AN46 _______________________________________________________________________ 1059. REVISED CIVIL MONEY PENALTIES, ASSESSMENTS, EXCLUSIONS, AND RELATED APPEALS PROCEDURES (CMS-6019-P) Priority: Info./Admin./Other Legal Authority: PL 108-173, sec 949 of MMA CFR Citation: 42 CFR 402.400 Legal Deadline: Final, Statutory, December 8, 2005. Abstract: Section 949 of the Medicare Modernization Act changed the designation of authority to request waiver of a program exclusion under the Social Security Act from the State to the Administrator of a Federal health care program. This rule will outline a process for health care providers to follow if they wish CMS to request a waiver of exclusion on their behalf (effective December 8, 2003). Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 04/00/05 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Joel Cohen, Health Insurance Specialist, CMS/OFM/PIG, Department of Health and Human Services, Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786-3349 Email: jcohen@cms.hhs.gov RIN: 0938-AN48 _______________________________________________________________________ 1060. MEDICARE MODERNIZATION ACT; ELECTRONIC PRESCRIBING (CMS-0011-P) Priority: Economically Significant. Major under 5 USC 801. Unfunded Mandates: This action may affect the private sector under PL 104-4. Legal Authority: 42 USC 1395 CFR Citation: Not Yet Determined Legal Deadline: Final, Statutory, September 2005, Required e- prescribing before outset of January 2006 Medicare part D drug benefit. Abstract: This rule proposes to enable transmission of basic prescription data to and from doctors and pharmacies, and to adopt a number of the initial standards required for electronic prescribing by section 1860(d) of the Medicare Modernization Act. (The proposed and subsequent final rule must be published by September 1, 2005, in order for the e-prescribing provisions to be in effect in advance of the beginning of the part D benefit and e-prescribing pilot projects in January 2006.) Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 11/00/04 Regulatory Flexibility Analysis Required: No Government Levels Affected: Federal, Local, State, Tribal Agency Contact: Gladys Wheeler, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786-0273 Email: gwheeler@cms.hhs.gov RIN: 0938-AN49 _______________________________________________________________________ 1061. FURNISHING HOSPITALS WITH INFORMATION TO COMPUTE THE DISPROPORTIONATE SHARE HOSPITAL FORMULA (CMS-1283-P) Priority: Economically Significant. Major status under 5 USC 801 is undetermined. Legal Authority: Section 1886 (d)(5)(F) of the Social Security Act; MMA, sec 951 CFR Citation: Not Yet Determined Legal Deadline: NPRM, Statutory, December 8, 2004. This provision is a requirement of the MMA and is effective one year after the date of the enactment of the Act (December 8, 2004). Abstract: Section 1886(d)(5)(F) of the Social Security Act provides additional payments to subsection (d) hospitals that serve a disproportionate share of low-income patients. Section 951 of the Medicare Modernization Act requires the Secretary to furnish hospitals with the data necessary to compute the number of patient days used in calculating the disproportionate patient percentage. This provision is effective December 8, 2004. We request this new regulation to solicit public comments and subsequently implement this required MMA provision. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 03/00/05 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: None Agency Contact: Sherry Amstead, Health Insurance Specialist, CMS/CMM/ HAPG/DAC, Department of Health and Human Services, Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786-4342 Email: samstead@cms.hhs.gov RIN: 0938-AN52 _______________________________________________________________________ 1062. END STAGE RENAL DISEASE (ESRD) COMPOSITE RATE EXCEPTION (CMS-1278-P) Priority: Substantive, Nonsignificant Legal Authority: MMA, sec 623; BIPA, sec 422 CFR Citation: Not Yet Determined Legal Deadline: None Abstract: This proposed rule will revise and update existing regulations to comply with the statutory changes in BIPA and MMA. Most changes will result in significant deletions to existing Regulation text. This notice is in response to MMA section 623 and BIPA section 422. The BIPA 2000 statute eliminates all future opportunities for renal dialysis facilities to file exception requests to obtain higher composite payment rates The MMA statute of 2003 (via changes to [[Page 73168]] BIPA 2000) restored composite rate exceptions only for pediatric renal dialysis facilities. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 06/00/05 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Michael E Powell, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786-4557 Email: mpowell@cms.hhs.gov RIN: 0938-AN53 _______________________________________________________________________ 1063. CHANGES TO THE HOSPITAL INPATIENT PROSPECTIVE PAYMENT SYSTEM AND FY 2006 RATES (CMS-1500-P) Priority: Economically Significant. Major status under 5 USC 801 is undetermined. Legal Authority: Sec 1886(d) of the Social Security Act CFR Citation: 42 CFR 412; 42 CFR 413; 42 CFR 485; 42 CFR 489 Legal Deadline: NPRM, Statutory, April 1, 2005. Final, Statutory, August 1, 2005. Abstract: This rule revises the Medicare acute hospital inpatient prospective payment system for operating and capital-related costs to implement changes arising from our continuing experience with these systems. It describes changes to the amounts and factors used to determine the rates for Medicare hospital inpatient services for operating costs and capital-related costs. These changes apply to discharges on or after October 1, 2005. The rule also sets forth proposed rate-of-increase limits as well as proposed policy changes for hospitals and hospital units excluded from the prospective payments systems. (The statute requires the final rule to be published by August 1, 2005.) Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 05/00/05 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: Federal Agency Contact: Tzvi Hefter, Director, Division of Acute Care, Department of Health and Human Services, Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786-4487 Email: thefter@cms.hhs.gov RIN: 0938-AN57 _______________________________________________________________________ 1064. MEDICARE PART B COMPETITIVE ACQUISITION OF OUTPATIENT DRUGS AND BIOLOGICALS (CMS-1325-P) Priority: Economically Significant. Major under 5 USC 801. Unfunded Mandates: Undetermined Legal Authority: MMA of 2003, sec 303(d) CFR Citation: 42 CFR 414 Legal Deadline: Final, Statutory, January 1, 2006, MMA of 2003, section 303(d) or section 1847(B)(a)(1) of the Social Security Act. Abstract: Section 303(d) of the Medicare Modernization Act requires the implementation of a competitive bidding program for Medicare part B drugs not paid on a cost or prospective payment system basis. Beginning January 1, 2006, physicians will be given a choice between purchasing these drugs and being paid by Medicare under the average sales price (ASP) system, or obtaining these drugs from vendors selected in a competitive bidding process. If the physician elects to obtain drugs from a competitive vendor, the vendor will bill Medicare for the drug. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 02/00/05 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: None Agency Contact: Edmund Erdvilas Kasaitis, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Center for Medicare Management, 7500 Security Boulevard, C4-01-26, Baltimore, MD 21224 Phone: 410 786-0477 Email: ekasaitis@cms.hhs.gov RIN: 0938-AN58 _______________________________________________________________________ 1065. REVISIONS TO THE OVERSIGHT AND VALIDATION PROGRAM FOR ACCREDITING ORGANIZATIONS APPROVED FOR DEEMING AUTHORITY (CMS-2255-P) Regulatory Plan: This entry is Seq. No. 65 in part II of this issue of the Federal Register. RIN: 0938-AN62 _______________________________________________________________________ 1066. SPECIAL PAYMENT PROVISIONS AND STANDARDS FOR SUPPLIERS OF CUSTOM FABRICATED ORTHOTICS AND PROSTHETICS (CMS-6012-P) Priority: Economically Significant. Major under 5 USC 801. Legal Authority: Benefits Improvement Protection Act of 2000 (BIPA 2000) CFR Citation: 42 CFR 410; 42 CFR 414; 42 CFR 424 Legal Deadline: None Abstract: Under this provision, Medicare will cover prosthetics and certain custom-fabricated orthotics only if furnished by a ``qualified practitioner'' and fabricated by a ``qualified practitioner'' or ``qualified supplier.'' The Secretary, in consultation with experts, is required to establish and periodically update a list of custom- fabricated orthotics and prosthetics subject to this rule. (Congress required that a final rule be published not later than one year after the date that section 427 of the BIPA was enacted.) Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 07/00/05 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: Undetermined Federalism: Undetermined Agency Contact: Theresa Linkowich, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, 7500 Security Boulevard, C3-02-16, Baltimore, MD 21224 Phone: 410 786-9249 [[Page 73169]] Email: tlinkowich@cms.hhs.gov RIN: 0938-AN63 _______________________________________________________________________ 1067. PROSPECTIVE PAYMENT SYSTEM AND CONSOLIDATED BILLING FOR SKILLED NURSING FACILITIES--UPDATE FOR FY 2006 (CMS-1282-P) Priority: Substantive, Nonsignificant. Major status under 5 USC 801 is undetermined. Unfunded Mandates: Undetermined Legal Authority: Social Security Act, sec 1888(e) CFR Citation: Not Yet Determined Legal Deadline: NPRM, Statutory, August 1, 2005, Updates payment rates. Abstract: This proposed rule updates payment rates used under the SNF PPS beginning October 1, 2005. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 04/00/05 Regulatory Flexibility Analysis Required: Undetermined Government Levels Affected: Undetermined Federalism: Undetermined Agency Contact: William Ullman, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, C4-13-15, Center for Medicaid and State Operations, 7500 Security Boulevard, C5-07-08, Baltimore, MD 21244 Phone: 401 786-5667 RIN: 0938-AN65 _______________________________________________________________________ Department of Health and Human Services (HHS) Final Rule Stage Centers for Medicare & Medicaid Services (CMS) _______________________________________________________________________ 1068. HOSPITAL CONDITIONS OF PARTICIPATION: LABORATORY SERVICES (CMS- 3014-IFC) Priority: Substantive, Nonsignificant Legal Authority: 42 USC 1302; 42 USC 1395hh CFR Citation: 42 CFR 482.27 Legal Deadline: None Abstract: This interim final rule with comment period requires hospitals that transfuse blood and blood products to prepare and follow written procedures for appropriate action when it is determined that blood and blood products the hospital received and transfused are at increased risk for transmitting HCV; quarantine prior collections from a donor who is at increased risk for transmitting HCV infection; notify transfusion recipients, as appropriate, of the need for HCV testing and counseling; and maintain records for at least 10 years. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 11/16/00 65 FR 69416 Interim Final Rule With Comment 06/00/05 Regulatory Flexibility Analysis Required: No Small Entities Affected: Businesses Government Levels Affected: None Agency Contact: Mary Collins, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Office of Clinical Standards and Quality, 7500 Security Boulevard, S3- 02-01, Baltimore, MD 21244 Phone: 410 786-3189 RIN: 0938-AJ29 _______________________________________________________________________ 1069. HEALTH COVERAGE PORTABILITY FOR GROUP HEALTH PLANS AND GROUP HEALTH INSURANCE ISSUERS (CMS-2151-F) Priority: Economically Significant. Major under 5 USC 801. Legal Authority: 42 USC 300gg; PL 104-191 CFR Citation: 45 CFR 144.103; 45 CFR 146.111; 45 CFR 146.113; 45 CFR 146.115; 45 CFR 146.117; 45 CFR 146.119; 45 CFR 146.120; 45 CFR 146.125; 45 CFR 146.143; . . . Legal Deadline: None Abstract: This final rule provides portability requirements for group health plans and issuers of health insurance coverage offered in connection with a group health plan under the Health Insurance Portability and Accountability Act of 1996. This regulation addresses limitations or preexisting exclusion periods on requests for special enrollments. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Interim Final Rule 04/08/97 62 FR 16894 Interim Final Rule Comment Period End 07/07/97 Interim Final Rule Effective 07/07/97 Final Action 11/00/04 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: Federal, Local, State Federalism: This action may have federalism implications as defined in EO 13132. Agency Contact: David Mlawsky, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, S3-16-26, Center for Medicaid and State Operations, 7500 Security Boulevard, S3-16-26, Baltimore, MD 21244 Phone: 410 786-6851 RIN: 0938-AL43 _______________________________________________________________________ 1070. PROSPECTIVE PAYMENT SYSTEM FOR INPATIENT PSYCHIATRIC FACILITIES FOR FY 2004 (CMS-1213-F) Priority: Economically Significant. Major under 5 USC 801. Legal Authority: PL 106-113; Sec 124 of the BBRA ; Sec 1886 of the Social Security Act CFR Citation: 42 CFR 412, subpart N; 42 CFR 413; 42 CFR 424 Legal Deadline: NPRM, Statutory, October 1, 2002, Public Law 106-113, sec 124. Abstract: This final rule would set forth a prospective payment system for Inpatient hospital services furnished by psychiatric hospitals and psychiatric units that will be effective January 1, 2005 (to establish the new system). Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 11/28/03 68 FR 66919 [[Page 73170]] NPRM Comment Period End 02/26/04 Final Action 12/00/04 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: Federal, Local, State Agency Contact: Lana Price, Director, Division of Chronic Care Management, Chronic Policy Group, Department of Health and Human Services, Centers for Medicare & Medicaid Services, C5-05-27, Center for Medicare Management, 7500 Security Boulevard, C5-05-27, Baltimore, MD 21244 Phone: 410 786-4533 Email: lprice@cms.hhs.gov RIN: 0938-AL50 _______________________________________________________________________ 1071. REQUEST FOR INFORMATION ON BENEFIT-SPECIFIC WAITING PERIODS (CMS- 2150-NC) Priority: Other Significant Legal Authority: Not Yet Determined CFR Citation: None Legal Deadline: None Abstract: This notice requests information on the use of benefit- specific waiting periods by group health plan and group health insurance issuers. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Notice 11/00/04 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: David Mlawsky, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, S3-16-26, Center for Medicaid and State Operations, 7500 Security Boulevard, S3-16-26, Baltimore, MD 21244 Phone: 410 786-6851 RIN: 0938-AL64 _______________________________________________________________________ 1072. REVISIONS TO THE MEDICARE APPEALS PROCESS (CMS-4004-FC) Priority: Other Significant Legal Authority: Sec 521 of BIPA CFR Citation: 42 CFR 405 Legal Deadline: NPRM, Statutory, October 1, 2002, Statutory effective date October 1, 2002. Abstract: This final rule with comment period addresses one discrete aspect of the November 15, 2002 proposed rule, ``Changes to the Medicare Claims Appeal Procedures'' (67 FR 69312). As required by section 1869(b)(1)(F) of the Social Security Act, this rule establishes expedited determination and reconsideration procedures for beneficiaries who are informed by a provider that Medicare coverage of their services is about to end. This rule implements section 937 of the Medicare Modernization Act which requires a process for correction of minor errors and omissions without pursing the appeals process. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 11/15/02 67 FR 69312 NPRM Comment Period End 01/14/03 Final Action 10/00/05 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: Undetermined Agency Contact: Janet Miller, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, N2-14-26, S1-06-04, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786-1588 RIN: 0938-AL67 _______________________________________________________________________ 1073. REVISIONS TO THE APPEALS PROCESS FOR INITIAL CLAIM DETERMINATIONS (CMS-4064-IFC) Priority: Economically Significant. Major status under 5 USC 801 is undetermined. Unfunded Mandates: Undetermined Legal Authority: Sec 521 of BIPA CFR Citation: 42 CFR 40S Legal Deadline: None Abstract: This interim final rule will revise the Medicare appeals process by adding five-tiered (five levels) of review. It will remove the distinction between the processing of initial determination and appeals under part A and part B required by section 521 of Benefits Improvement and Protection Act of 2000 (BIPA). Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Interim Final Rule 12/00/04 Regulatory Flexibility Analysis Required: No Government Levels Affected: Federal Agency Contact: Michele Edmondson-Parrott, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, 7500 Security Boulevard, S1-05-06, Baltimore, MD 21244 Phone: 410 786-6478 Related RIN: Related to 0938-AK69 RIN: 0938-AM73 _______________________________________________________________________ 1074. CONDITIONS FOR COVERAGE OF POWER MOBILITY DEVICES, INCLUDING POWERED WHEELCHAIRS AND POWER-OPERATED VEHICLES SCOOTER(CMS-3017-IFC) Priority: Substantive, Nonsignificant. Major status under 5 USC 801 is undetermined. Legal Authority: Sec 1102 of the Social Security Act; Sec 1871 of the Social Security Act; 42 USC 1302 ; 42 USC 1359 hh CFR Citation: 42 CFR 410.38 Legal Deadline: None Abstract: This rule will make the requirements to purchase power operated vehicles, functioning as wheelchairs, less stringent. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Interim Final Rule 12/00/04 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Lorrie Ballantine, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, S3-02-01, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786-7543 Karen Daily, Health Insurance Specialist, Department of Health and [[Page 73171]] Human Services, Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786-0189 Email: kdaily@cms.hhs.gov RIN: 0938-AM74 _______________________________________________________________________ 1075. CHANGES TO THE HOSPITAL OUTPATIENT PROSPECTIVE SYSTEM AND CALENDAR YEAR 2005 PAYMENT RATES (CMS-1427-FC) Priority: Economically Significant. Major under 5 USC 801. Legal Authority: 42 USC 1395L; Balanced Budget Act of 1997; Medicare, Medicaid and SCHIP Balanced Budget Refinement Act of 1999; Medicare, Medicaid, and SCHIP Benefits Improvement and Protection Act of 2000 CFR Citation: Not Yet Determined Legal Deadline: Final, Statutory, January 1, 2005. Abstract: The rule revises the Medicare hospital outpatient prospective payment system beginning January 1, 2005. It also responds to comments received from the 2004 Outpatient PPS update (CMS-1371-IFC). Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 08/16/04 69 FR 50497 Final Action 11/00/04 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: Federal Agency Contact: Cindy Read, Division Director, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Center for Medicare Mangement, 7500 Security Boulevard, C4-05-07, Baltimore, MD 21244 Phone: 410 786-1852 Related RIN: Related to 0938-AM96 RIN: 0938-AM75 _______________________________________________________________________ 1076. REVISIONS TO PAYMENT POLICIES UNDER THE PHYSICIAN FEE SCHEDULE FOR CALENDAR YEAR 2005 (CMS-1429-FC) Priority: Economically Significant. Major under 5 USC 801. Legal Authority: 42 USC 1395W-4 CFR Citation: 42 CFR 410; 42 CFR 414 Legal Deadline: NPRM, Statutory, June 1, 2004, Revisions to Payment Policies. Final, Statutory, January 1, 2005. Abstract: This final rule with comment period makes several changes affecting Medicare part B payment. It also includes several provisions on preventive care from the Medicare Modernization Act including, initial preventive physical examination, cardiovascular screening blood tests, and diabetes screening tests. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 08/05/04 69 FR 47488 NPRM Comment Period End 09/24/04 Final Action 11/00/04 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: Federal Agency Contact: Latesha Walker, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Center for Medicare Management, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786-1101 Related RIN: Related to 0938-AM97 RIN: 0938-AM90 _______________________________________________________________________ 1077. MEDICARE ADVANTAGE PROGRAM--TITLE II (CMS-4069-F) Regulatory Plan: This entry is Seq. No. 66 in part II of this issue of the Federal Register. RIN: 0938-AN06 _______________________________________________________________________ 1078. MEDICARE DRUG BENEFIT EFFECTIVE CALENDAR YEAR 2006--TITLE I (CMS- 4068-F) Regulatory Plan: This entry is Seq. No. 67 in part II of this issue of the Federal Register. RIN: 0938-AN08 _______________________________________________________________________ 1079. SCHEDULE FOR PUBLISHING MEDICARE FINAL REGULATIONS AFTER A PROPOSED OR INTERIM FINAL REGULATION (CMS-9026-N) Priority: Other Significant Legal Authority: Sec 902 of the Medicare Modernization Act of 2003 CFR Citation: None Legal Deadline: None Abstract: In accordance with Section 902 of the Medicare Modernization Act of 2003, this rule establishes a regular timeline for the publication of final regulations based on the previous publication of a proposed or interim final regulation. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Notice 11/00/04 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Renee Swann, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Office of Strategic Operations and Regulatory Affairs, C5-14-03, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786-4492 Email: rswann@cms.hhs.gov RIN: 0938-AN12 _______________________________________________________________________ 1080. EVALUATION CRITERIA AND STANDARDS FOR QUALITY IMPROVEMENT PROGRAM CONTRACTS (CMS-3142-NC) Priority: Info./Admin./Other. Major status under 5 USC 801 is undetermined. Legal Authority: Sec 1153(h)(2) of the Social Security Act CFR Citation: None Legal Deadline: Final, Statutory, August 31, 2004. There is a 60 day comment period required for the evaluation criteria used in evaluating the Quality Improvement Organizations. Abstract: Section 1153(h)(2) of the Act Social Security requires the Secretary to publish in the Federal Register the general criteria and standards that will be used to evaluate the Quality Improvement Organizations (QIOs), and provide opportunity for public comment. This notice will describe the evaluation criteria CMS will use to evaluate the QIOs. There should be no additional costs associated with this requirement. The evaluation portion of the contract has already been factored into the award. (This notice with comment period must be published by May 28, 2004, to allow sufficient time [[Page 73172]] for receipt and response to comments prior to the first round of QIO evaluations beginning November 2004. Delaying the first round of evaluations will delay the statutory requirement to notify QIOs of nonrenewal of their current contracts 90 days prior to their expiration, as well as extend the QIOs' work beyond the current contract period.) Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Notice With Comment Period 07/23/04 69 FR 44031 Comment Period End 08/23/04 Final Action 04/00/05 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Maria L, Hammel, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Office of Clinical Standards and Quality, 7500 Security Boulevard, S2-01-01, Baltimore, MD 21244 Phone: 410 786-1775 Email: mhammel@cms.hhs.gov RIN: 0938-AN13 _______________________________________________________________________ 1081. MEDICARE SECONDARY PAYER (MSP): WORKMEN'S COMPENSATION (CMS-6272- IFC) Priority: Substantive, Nonsignificant. Major status under 5 USC 801 is undetermined. Legal Authority: Sec 301 of the Medicare Prescripition Drug, Improvement, and Modernization Act of 2003 CFR Citation: 42 CFR 411 Legal Deadline: Final, Statutory, December 8, 2003. Abstract: Section 301 of the Medicare Modernization Act clarifies when CMS may make a conditional Medicare payment when other insurance cannot reasonably be expected to make a prompt payment (effective December 8, 2003). Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Interim Final Rule With Comment Period 06/00/05 Regulatory Flexibility Analysis Required: No Government Levels Affected: Undetermined Agency Contact: Suzanne Ripley, Health Insurance Specialist Office of Finanical Management, Department of Health and Human Services, Centers for Medicare & Medicaid Services, 7500 Security Boulevard, C4-25-02, Baltimore, MD 21244 Phone: 410 786-0970 Email: sripley@cms.hhs.gov RIN: 0938-AN27 _______________________________________________________________________ 1082. FIRE SAFETY REQUIREMENTS FOR CERTAIN HEALTH CARE FACILITIES; ALCOHOL-BASED HAND SANITIZER AMENDMENT (CMS-3145-IFC) Priority: Other Significant Legal Authority: Not Yet Determined CFR Citation: None Legal Deadline: None Abstract: This interim final rule with comments would amend the fire safety standard for religious nonmedical health care institutions, hospices, programs of all-inclusive care for the elderly, hospitals, long-term care facilities, intermediate care facilities for the mentally retarded, and critical access hospitals that participate in Medicare and Medicaid. The rule would adopt a change made to the 2000 edition of the Life Safety Code (LSC) published by the National Fire Protection Association (NFPA). We adopted the 2000 edition of the LSC in January 2003. The LSC change would allow facilities to place alcohol-based hand sanitizer dispensers in exit corridors under certain conditions. These sanitizers have proven to be effective in increasing hand hygiene and have the potential to improve infection control practice. Adopting the LSC change would increase a provider's flexibility in meeting infection control goals while minimizing potential fire safety concerns. Additionally, this rule would include a requirement for placement of battery operated smoke detectors in resident rooms in non-sprinkled SNFs. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Interim Final Rule With Comments12/00/04 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Additional Information: Providers requesting publication of this regulation. Agency Contact: Danielle Shearer, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Office of Clinical Standards and Quality, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786-6617 RIN: 0938-AN36 _______________________________________________________________________ 1083. MODIFICATIONS TO MANAGED CARE RULES (CMS-4041- IFC) Priority: Other Significant Legal Authority: 1857(g)(3)(a) CFR Citation: 42 CFR 422 Legal Deadline: None Abstract: In the August 22, 2003, issue of the Federal Register, we published a final rule titled `` Modifications to Medicare Rules'' (68 FR 50840). The effective date for that final rule was September 22, 2003. This interim final rule with comment period corrects a limited number of technical and typographical errors identified in the August 22, 2003, final rule. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Interim Final Rule 12/00/04 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Tony Hausner, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, 7500 Security Boulevard, C4-24-02, Baltimore, MD 21244 Phone: 410 786-1093 Related RIN: Related to 0938-AK71 RIN: 0938-AN38 _______________________________________________________________________ 1084. DEVELOPMENT OF NEW STANDARDS FOR MEDIGAP POLICIES (CMS-2197-FN) Priority: Substantive, Nonsignificant. Major status under 5 USC 801 is undetermined. Legal Authority: Section 104 of the MMA [[Page 73173]] CFR Citation: None Legal Deadline: None Abstract: According to section 104 of the MMA, Medigap issuers must send written notice to beneficiaries with Medigap drug coverage during the 60-day period immediately preceding the initial Medicare part D enrollment period which begins November 15, 2005. Therefore, Medigap issuers will have to send the notices from mid-September 2005 to mid- November 2005. This final notice will set forth the standards for the written notice that Medigap issuers must provide to policyholders with drug coverage. (The final notice must be published by May 27, 2005, to give Medigap issuers sufficient time to send notices). Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Final Notice 05/00/05 Regulatory Flexibility Analysis Required: No Government Levels Affected: None Agency Contact: Kathryn D. McCann, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Center for Medicaid and State Operations, 7500 Security Boulevard, S3-16-16, Baltimore, MD 21224 Phone: 410 786-7623 Email: kmccann@cms.hhs.gov RIN: 0938-AN50 _______________________________________________________________________ 1085. TIME LIMITATION ON RECORDKEEPING REQUIREMENTS UNDER THE DRUG REBATE PROGRAM (CMS-2175-F) Priority: Other Significant. Major status under 5 USC 801 is undetermined. Legal Authority: 42 USC 1396 CFR Citation: 42 CFR 447.534 Legal Deadline: None Abstract: This final rule finalizes the 10-year recordkeeping requirements. Manufacturers must retain records for 10 years from the date the manufacturer reports data to us for a rebate period. This final rule also finalizes the requirement that manufacturers must retain records beyond the 10-year period if the records are known by the manufacturer to be the subject of an audit or a government investigation. Furthermore, it responds to public comments on the January 6, 2004, interim final rule with comment period and the proposed rule pertaining to the 10-year recordkeeping comments, respectively. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Interim Final Rule With Comments01/06/04 69 FR 508 Final Action 11/00/04 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: State Federalism: Undetermined Agency Contact: Kimberly M. Howell, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786-6762 Email: khowell@cms.hhs.gov Larry Reed, Chief, Medicaid Noninstitutional Payment Policy Branch, Department of Health and Human Services, Centers for Medicare & Medicaid Services, S2-01-16, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786-3325 Related RIN: Related to 0938-AM20 RIN: 0938-AN55 _______________________________________________________________________ 1086. FISCAL YEAR 2006 SCHIP ALLOTMENTS (CMS-2219-N) Priority: Economically Significant Legal Authority: Title XXI of the Social Security Act, sec 2104 CFR Citation: 42 CFR 457 Legal Deadline: None Abstract: This notice sets forth the final allotments of Federal funding available to each State, the District of Columbia, and each U.S. Territory and Commonwealth for fiscal year 2006. (The notice must be published on August 27, 2004, so that the funds can be distributed to the States before September 30, 2005, as required by the statute.) Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Notice 08/00/05 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: State Agency Contact: Richard Strauss, Director, Division of Financial Management, Department of Health and Human Services, Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786-2019 Email: rstrauss@cms.hhs.gov RIN: 0938-AN56 _______________________________________________________________________ Department of Health and Human Services (HHS) Long-Term Actions Centers for Medicare & Medicaid Services (CMS) _______________________________________________________________________ 1087. REQUIREMENTS FOR ESTABLISHING AND MAINTAINING MEDICARE BILLING PRIVILEGES (CMS-6002-F) Priority: Other Significant Legal Authority: 42 USC 1302; 42 USC 1395hh CFR Citation: 42 CFR 424 Legal Deadline: None Abstract: This final rule is needed as part of the Administration's anti-fraud and abuse efforts. It would give HHS the authority to enroll and reenroll providers with time frames for reenrollment. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 04/25/03 68 FR 22064 Final Action 04/00/06 Regulatory Flexibility Analysis Required: No Small Entities Affected: Businesses Government Levels Affected: None [[Page 73174]] Agency Contact: Michael Collett, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Office of Financial Management, C3-02-06, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786-6121 RIN: 0938-AH73 _______________________________________________________________________ 1088. MEDICARE OUTCOME AND ASSESSMENT INFORMATION SET (OASIS) DATA REPORTING REQUIREMENTS (CMS-3006-F) Priority: Other Significant. Major under 5 USC 801. Unfunded Mandates: This action may affect State, local or tribal governments and the private sector. Legal Authority: 42 USC 1302; 42 USC 1395(hh) CFR Citation: 42 CFR 484.11; 42 CFR 484.20; 42 CFR 488.68 Legal Deadline: None Abstract: This final rule requires home health agencies to electronically report OASIS data as a condition of participation in the Medicare program. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Interim Final Rule 01/25/99 64 FR 3748 Final Action 12/00/06 Regulatory Flexibility Analysis Required: Undetermined Small Entities Affected: Businesses Government Levels Affected: State, Local, Tribal Federalism: This action may have federalism implications as defined in EO 13132. Agency Contact: Rebecca Donnay, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Office of Clinical Standards and Quality, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786-1428 RIN: 0938-AJ10 _______________________________________________________________________ 1089. MEDICARE HOSPICE CARE AMENDMENTS (CMS-1022-F) Priority: Substantive, Nonsignificant Legal Authority: PL 105-33, sec 1961(dd); PL 105-33, sec 1814(i); PL 105-33, sec 4441 to 4444; PL 105-33, sec 4448; PL 106-113, sec 131; PL 106-554, sec 321; PL 106-554, sec 322; PL 105-33, sec 4449 CFR Citation: 42 CFR 418 Legal Deadline: None Abstract: This final rule revises certain regulations governing coverage and payments for hospice care under the Medicare program as required by the Balanced Budget Act of 1997. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 11/22/02 67 FR 70363 Final Action 11/00/05 Regulatory Flexibility Analysis Required: No Small Entities Affected: Businesses Government Levels Affected: None Agency Contact: Thomas Saltz, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, C4-05-27, Centers for Medicare Management, 7500 Security Boulevard, C4- 05-27, Baltimore, MD 21244 Phone: 410 786-4480 Related RIN: Previously reported as 0938-AH73 RIN: 0938-AJ36 _______________________________________________________________________ 1090. USE OF RESTRAINT AND SECLUSION IN RESIDENTIAL TREATMENT FACILITIES PROVIDING INPATIENT PSYCHIATRIC SERVICES TO INDIVIDUALS UNDER AGE 21 (CMS-2065-F) Priority: Other Significant Legal Authority: 42 USC 1302; 42 USC 1396d CFR Citation: 42 CFR 441 to 442; 42 CFR 483 Legal Deadline: None Abstract: This rule addresses standards of practice that residential treatment facilities providing inpatient psychiatric services for individuals under age 21 must meet with regard to the use of restraints (including psychoactive drugs) and seclusion. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Interim Final Rule 01/22/01 66 FR 7148 60-Day Delay of Effective Date To 05/22/2001 03/21/01 66 FR 15800 Interim Final Rule Comment Period End 03/23/01 Interim Final Rule Effective 03/23/01 Interim Final Rule Amendment with Clarification 05/22/01 66 FR 28110 Interim Final Rule Comment Period End 07/23/01 Final Action 12/00/06 Regulatory Flexibility Analysis Required: No Small Entities Affected: Businesses Government Levels Affected: None Agency Contact: Larry Cutler, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, S2-14-26, Center for Medicaid and State Operations, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786-5903 RIN: 0938-AJ96 _______________________________________________________________________ 1091. PHYSICIANS' REFERRALS TO HEALTH CARE ENTITIES WITH WHICH THEY HAVE FINANCIAL RELATIONSHIPS--PHASE II (CMS-1810-IFC) Priority: Other Significant Legal Authority: 42 USC 1877 CFR Citation: 42 CFR 411; 42 CFR 424 Legal Deadline: None Abstract: This final rule incorporates into regulation certain statutory provisions that preclude payment for services under Medicare if a physician makes a referral to a facility in which he/she has a financial interest. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Interim Final Rule 03/26/04 69 FR 16054 Interim Final Rule Comment Period End 06/24/04 Correction Notice 04/06/04 69 FR 17933 Second Correction Notice 09/24/04 69 FR 57226 Final Action 06/00/07 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses, Organizations Government Levels Affected: None [[Page 73175]] Agency Contact: Joanne Sinsheimer, Technical Advisor, CMM, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Center for Medicaid and State Operations, 7500 Security Boulevard, C4- 25-02, Baltimore, MD 21244 Phone: 410 786-4620 RIN: 0938-AK67 _______________________________________________________________________ 1092. PROVIDER REIMBURSEMENT DETERMINATIONS AND APPEALS (CMS-1727-F) Priority: Substantive, Nonsignificant Legal Authority: Sec 1878 of the Social Security Act CFR Citation: 42 CFR 405 Legal Deadline: None Abstract: This final rule would redefine, clarify, and update the guidelines and procedures for Provider Reimbursement Review Board appeals, based on recent court decisions. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 06/25/04 69 FR 35716 NPRM Comment Period End 08/24/04 Final Action 06/00/07 Regulatory Flexibility Analysis Required: No Small Entities Affected: Businesses Government Levels Affected: None Agency Contact: Morton Marcus, Heal Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, 7500 Security Boulevard, C4-25-02, Baltimore, MD 21244 Phone: 410 786-4477 RIN: 0938-AL54 _______________________________________________________________________ 1093. DMERC SERVICE AREAS AND RELATED MATTERS (CMS-1219-F) Priority: Substantive, Nonsignificant Legal Authority: Sec 1842 of the Social Security Act; Sec 1834(a)(12) of the Social Security Act; Sec 1834(h)(3) of the Social Security Act; Sec 1834(j)(1) of the Social Security Act CFR Citation: 42 CFR 421.210 Legal Deadline: None Abstract: This rule allows flexibility in making changes to the DMERC contractor structure. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 03/26/04 69 FR 15755 NPRM Comment Period End 05/25/04 Final Action 03/00/07 Regulatory Flexibility Analysis Required: No Small Entities Affected: Businesses Government Levels Affected: None Agency Contact: Colette Shatto, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, S1-01-26, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786-6932 RIN: 0938-AL76 _______________________________________________________________________ 1094. ELECTRONIC MEDICARE CLAIMS SUBMISSION (CMS-0008-F) Priority: Other Significant Legal Authority: PL 107-105 CFR Citation: Not Yet Determined Legal Deadline: None Abstract: This final rule implements the requirements for electronic submission of Medicare claims, submitted on or after October 16, 2003. In addition, this rule also implements the conditions upon which a waiver could be granted for these requirements. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Interim Final Rule 08/15/03 68 FR 48805 Interim Final Rule Comment Period End 10/16/03 Final Action 08/00/06 Regulatory Flexibility Analysis Required: Undetermined Government Levels Affected: None Agency Contact: Stewart Streimer, Director, Provider Billing Group, Department of Health and Human Services, Centers for Medicare & Medicaid Services, 7500 Security Boulevard, C4-10-07, Baltimore, MD 21244 Phone: 410 786-9318 Email: sstrimer@cms.hhs.gov RIN: 0938-AM22 _______________________________________________________________________ 1095. PROCEDURES FOR MAINTAINING CODE LISTS IN THE NEGOTIATED NATIONAL COVERAGE DETERMINATIONS FOR CLINICAL DIAGNOSTIC LABORATORY SERVICES (CMS-3119-FN) Priority: Other Significant Legal Authority: 42 USC 1395h(a); 42 USC 1395e; 42 USC 1395u(a); 42 USC 1395x; 42 USC 1395y(a)(1)(A); 42 USC 1395y(a)(7) CFR Citation: None Legal Deadline: None Abstract: This final rule establishes the procedures to be used for maintaining the lists of codes that were included in the national coverage determinations (NCDs) announced on November 25, 2001. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 12/24/03 68 FR 74607 NPRM Comment Period End 02/23/04 Final Action 12/00/06 Regulatory Flexibility Analysis Required: No Small Entities Affected: Businesses Government Levels Affected: None Agency Contact: Jacqueline Sheridan, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Office of Clinical Standards and Quality, 7500 Security Boulevard, C1-09-06, Baltimore, MD 21244 Phone: 410 786-4635 RIN: 0938-AM36 _______________________________________________________________________ 1096. REQUIREMENTS FOR LONG TERM CARE FACILITIES; NURSING SERVICES; POSTING OF NURSE STAFFING INFORMATION (CMS-3121-F) Priority: Other Significant Legal Authority: Sec 1819(b) of the Social Security Act; 42 USC 1395i- 3(b) CFR Citation: 42 CFR 483 Legal Deadline: None Abstract: This final rule implements section 941 of the Medicare, Medicaid, and SCHIP Benefits Improvement and Protection Act of 2000 and requires nursing homes to post daily, for each shift, the number of full-time equivalents (FTEs) of registered nurses, [[Page 73176]] licensed practical nurses, licensed vocational nurses, and certified nurse aides who are directly responsible for resident care. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 02/27/04 69 FR 9282 NPRM Comment Period End 04/27/04 Final Action 02/00/07 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Anita Panicker, Department of Health and Human Services, Centers for Medicare & Medicaid Services, S3-04-26, Office of Clinical Standards and Quality, 7500 Security Boulevard, S3-02-01, Baltimore, MD 21244 Phone: 410 786-5646 RIN: 0938-AM55 _______________________________________________________________________ 1097. REVISED CIVIL MONEY PENALTIES, ASSESSMENTS, EXCLUSIONS, AND RELATED APPEALS PROCEDURES (CMS-6146-F) Priority: Substantive, Nonsignificant. Major status under 5 USC 801 is undetermined. Unfunded Mandates: Undetermined Legal Authority: Not Yet Determined CFR Citation: Not Yet Determined Legal Deadline: None Abstract: This final rule proposes revisions to the CMS civil money penalty authorities. These proposed revisions are intended to add the specific exclusion sanction authorities as established in the procedures for imposing civil money penalties, assessments, and exclusions for certain violations of the Medicare and Medicaid programs. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 07/23/04 69 FR 43956 Final Action 07/00/07 Regulatory Flexibility Analysis Required: Undetermined Government Levels Affected: Undetermined Agency Contact: Joel Cohen, Office of Financial Management, Department of Health and Human Services, Centers for Medicare & Medicaid Services, C3-04-06, 7500 Security Boulevard, Baltimore, MD 21244-1850 Phone: 410 786-3349 RIN: 0938-AM98 _______________________________________________________________________ 1098. PAYMENT FOR RESPIRATORY ASSIST DEVICES WITH BI-LEVEL CAPABILITY AND A BACK-UP RATE (CMS-1167-F) Priority: Other Significant Legal Authority: 42 USC 1395(m)(3) CFR Citation: 42 CFR 414.222(a)(1) Legal Deadline: Final, Statutory, August 22, 2006, MMA, section 902. Abstract: This final rule clarifies that respirator assist devices with bi-level capability and a back-up rate must be classified as capped rental durable medical equipment (DME) in accordance with section 1834(a)(3) of the Social Security Act (42 U.S.C. 1395(m)(3)). Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Final Action 08/00/06 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: None Agency Contact: Joel Kaiser, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Center for Medicare Management, 7500 Security Boulevard, C5-07-26, Baltimore, MD 21244 Phone: 410 786-4499 Email: jkaiser@cms.hhs.gov Related RIN: Related to 0938-AL27 RIN: 0938-AN02 _______________________________________________________________________ 1099. NONDISCRIMINATION IN POST-HOSPITAL REFERRAL TO HOME HEALTH AGENCIES AND OTHER ENTITIES (CMS-1224-F) Priority: Substantive, Nonsignificant Legal Authority: PL 105-33, sec 4321 of the BBA CFR Citation: 42 CFR 482 Legal Deadline: None Abstract: This final rule establishes a process for collecting and maintaining information about hospitals referring Medicare patients to home health agencies (HHAs) with which the hospitals have a financial interest. Collected information will be available to the public to enhance its understanding and awareness of the availability of Medicare-certified HHAs to serve the Medicare population. (This final rule must be published by November 22, 2005, to meet the three-year publication deadline.) Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 11/22/02 67 FR 70373 Final Action 11/00/05 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Elizabeth Carmody, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Center for Medicare Management, 7500 Security Boulevard, C4-10-07, Baltimore, MD 21244 Phone: 410 786-7533 Email: ecarmody@cms.hhs.gov RIN: 0938-AN19 _______________________________________________________________________ 1100. MEDICARE AMBULANCE FEE SCHEDULE UPDATE (CMS-1492-F) Priority: Economically Significant Legal Authority: Sec 1834(i) of the Social Security Act; Sec 414 of the MMA CFR Citation: 42 CFR 414, subpart H Legal Deadline: Final, Statutory, July 1, 2004, Interim final. Abstract: Section 414 of the Medicare Modernization Act provides for temporary increases to the Medicare ambulance fee schedule beginning July 1, 2004. It also increases mileage payments for certain long trips. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Interim Final Rule 07/01/04 69 FR 40288 Interim Final Rule Comment Period End 08/30/04 Final Action 07/00/07 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: Local Agency Contact: Robert Niemann, Health Insurance Specialist, [[Page 73177]] CMS/CMM/HAPG/DAS, Department of Health and Human Services, Centers for Medicare & Medicaid Services, 7500 Security Boulevard, C4-05-17, Baltimore, MD 21244 Phone: 410 786-4596 Email: rnieman@cms.hhs.gov RIN: 0938-AN24 _______________________________________________________________________ 1101. NONDISCRIMINATION IN HEALTH COVERAGE AND WELLNESS PLANS IN THE GROUP MARKET (CMS-2022-F) Priority: Substantive, Nonsignificant. Major status under 5 USC 801 is undetermined. Legal Authority: 42 USC 300gg CFR Citation: 45 CFR 146.121 Legal Deadline: None Abstract: This document contains final rules governing the provisions prohibiting discrimination based on a health factor for group health plans and issuers of health insurance coverage offered in connection with a group health plan. The rules contained in this document implement changes made to the Internal Revenue Code of 1986 (Code), the Employee Retirement Income Security Act of 1974, and the Public Health Service Act enacted as part of the Health Insurance Portability and Accountability Act of 1966. It also addresses comments we received on the Bonafide Wellness Plan proposed rule (CMS-2078-P). Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Interim Final Rule 04/08/97 62 FR 16894 Interim Final Rule Comment Period End 07/17/97 Interim Final Rule Effective 07/17/97 Interim Final Rule 01/08/01 66 FR 1378 Interim Final Rule Effective 03/09/01 Interim Final Rule Comment Period End 04/09/01 Final Action 12/00/06 Regulatory Flexibility Analysis Required: No Small Entities Affected: Businesses, Governmental Jurisdictions Government Levels Affected: Local, State Agency Contact: David Mlawsky, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Center for Medicaid and State Operations, 7500 Security Boulevard, S3- 16-26, Baltimore, MD 21244 Phone: 410 786-6851 Email: dmlawsky@cms.hhs.gov RIN: 0938-AN29 _______________________________________________________________________ 1102. HOSPITAL CONDITIONS OF PARTICIPATION: PATIENTS' RIGHTS (CMS-3018- F) Priority: Other Significant. Major status under 5 USC 801 is undetermined. Legal Authority: 42 USC 1395x; 42 USC 1396d; 42 USC 1395bb CFR Citation: 42 CFR 482 Legal Deadline: None Abstract: This final rule sets forth standards for the use of restraints and seclusion in Medicare- and Medicaid-participating hospitals as part of the Patients' Rights Condition of Participation (CoP) and finalizes other patients' rights afforded by that CoP. It finalizes six standards that ensure minimum protections of each patient's physical and emotional health and safety. These standards address each patient's right to: notification of his or her rights; the exercise of his or her rights in regard to his or her care; privacy and safety; confidentiality of patient records; freedom from restraints used in the provision of acute medical and surgical care unless clinically necessary; and freedom from seclusion and restraint for behavior management unless clinically necessary. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Interim Final Rule 07/02/99 64 FR 36069 Final Action 12/00/06 Regulatory Flexibility Analysis Required: No Government Levels Affected: None Agency Contact: Patricia Chmielewski, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Office of Clinical Standards and Quality, 7500 Security Boulevard, S3-02-01, Baltimore, MD 21244 Phone: 410 786-6899 Email: pchmielewski@cms.hhs.gov RIN: 0938-AN30 _______________________________________________________________________ 1103. FEDERAL ENFORCEMENT IN GROUP AND INDIVIDUAL HEALTH INSURANCE MARKETS (CMS-2019-F) Priority: Other Significant Legal Authority: 42 USC 300gg-22; 42 USC 300gg-31 CFR Citation: 45 CFR 150.101 to 150.465 Legal Deadline: None Abstract: This rule finalizes, without any substantive changes, an interim final regulation (HCFA-2019-IFC) that sets forth the process by which CMS enforces the HIPAA title I requirements with regard to State and local governmental group health plans. It also finalizes the process by which CMS assumes direct enforcement responsibility in a State with regard to group and individual market health insurance issues. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Interim Final Rule 08/20/99 64 FR 1999 Final Action 12/00/06 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: Local, State Agency Contact: David Mlawsky, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, S3-16-26, Center for Medicaid and State Operations, 7500 Security Boulevard, S3-16-26, Baltimore, MD 21244 Phone: 410 786-6851 RIN: 0938-AN35 _______________________________________________________________________ 1104. GROUP MARKET HEALTH INSURANCE REFORM: GUARANTEED AVAILABILITY, GUARANTEED RENEWABILITY, DISCLOSURES TO SMALL EMPLOYERS (CMS-2216-F) Priority: Other Significant. Major status under 5 USC 801 is undetermined. Legal Authority: 42 USC 300gg-92 CFR Citation: 45 CFR 146.150; 45 CFR 146.152; 45 CFR 146.160 Legal Deadline: None Abstract: This regulation finalizes the interim final regulation (BPD- 890-IFC) guaranteeing the availability of health insurance coverage to small employers, and guaranteeing the renewability of [[Page 73178]] health insurance coverage to small and large employers. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Final Action 12/00/06 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: David R. Mlawsky, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Center for Medicaid and State Operations, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 877 267-2323 Email: dmlawsky@cms.hhs.gov RIN: 0938-AN60 _______________________________________________________________________ 1105. INDIVIDUAL MARKET HEALTH INSURANCE REFORM: PORTABILITY FROM GROUP TO INDIVIDUAL COVERAGE; FEDERAL RULES FOR ACCESS IN THE INDIVIDUAL MARKET; STATE ALTERNATIVE MECHANISMS TO FEDERAL RULES (CMS-2217-F) Priority: Other Significant. Major under 5 USC 801. Legal Authority: 42 USC 300gg-92 CFR Citation: 42 CFR 148.11; 42 CFR 148.102; 42 CFR 148.103; 42 CFR 148.122; 42 CFR 148.1 Legal Deadline: None Abstract: This regulation finalizes the interim final rule (BPD-890- IFC) that guarantees availability of health coverage to certain individuals, guarantees renewability of coverage in the individual market, and sets standards for State alternative mechanisms for guaranteeing coverage to certain individuals. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Final Action 12/00/06 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: David R. Mlawsky, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Center for Medicaid and State Operations, 7500 Security Boulevard, S3-16-16, Baltimore, MD 21244 Phone: 877 267-2323 Email: dmlawsky@cms.hhs.gov RIN: 0938-AN61 _______________________________________________________________________ Department of Health and Human Services (HHS) Completed Actions Centers for Medicare & Medicaid Services (CMS) _______________________________________________________________________ 1106. CONTINUATION OF MEDICARE ENTITLEMENT WHEN DISABILITY BENEFIT ENDS BECAUSE OF SUBSTANTIAL GAINFUL ACTIVITY (CMS-4018-F) Priority: Economically Significant CFR Citation: 42 CFR 406.12 Completed: ________________________________________________________________________ Reason Date FR Cite ________________________________________________________________________ Final Action 09/24/04 69 FR 57224 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Denise Cox Phone: 410 786-3195 RIN: 0938-AK94 _______________________________________________________________________ 1107. INTEREST CALCULATION (CMS-6014-F) Priority: Other Significant CFR Citation: 42 CFR 405.378; 42 CFR 411.24 Completed: ________________________________________________________________________ Reason Date FR Cite ________________________________________________________________________ Final Action 07/30/04 69 FR 45604 Regulatory Flexibility Analysis Required: No Small Entities Affected: Businesses, Organizations Government Levels Affected: None Agency Contact: Nancy Braymer Phone: 410 786-4323 RIN: 0938-AL14 _______________________________________________________________________ 1108. HOSPITAL PATIENTS' RIGHTS COP--STANDARD SAFETY COMPLIANCE COMMITTEES (CMS-3120-P) Priority: Economically Significant. Major under 5 USC 801. CFR Citation: 42 CFR 482 Completed: ________________________________________________________________________ Reason Date FR Cite ________________________________________________________________________ Withdrawn 06/30/04 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses, Organizations Government Levels Affected: Undetermined Federalism: Undetermined Agency Contact: Rachael Weinstein Phone: 410 786-6775 RIN: 0938-AM39 _______________________________________________________________________ 1109. PROSPECTIVE PAYMENT SYSTEM AND CONSOLIDATED BILLING FOR SKILLED NURSING FACILITIES--UPDATE FOR FY 2006 (CMS-1249-N) Priority: Other Significant. Major under 5 USC 801. CFR Citation: 42 CFR 413.330 to 413.350 Completed: ________________________________________________________________________ Reason Date FR Cite ________________________________________________________________________ Notice 07/30/04 69 FR 45775 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: None Agency Contact: William Ullman Phone: 401 786-5667 RIN: 0938-AM46 _______________________________________________________________________ 1110. TITLE I: NON-FEDERAL GOVERNMENTAL PLANS EXEMPT FROM HIPAA (CMS- 2033-F) Priority: Substantive, Nonsignificant CFR Citation: 45 CFR 146.180 Completed: ________________________________________________________________________ Reason Date FR Cite ________________________________________________________________________ Final Action 07/23/04 69 FR 43926 [[Page 73179]] Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: Local, State Agency Contact: Dave Holstein Phone: 410 786-1564 Related RIN: Related to 0938-AK00 RIN: 0938-AM71 _______________________________________________________________________ 1111. HOSPICE WAGE INDEX FY 2005 (CMS-1264-N) Priority: Routine and Frequent CFR Citation: None Completed: ________________________________________________________________________ Reason Date FR Cite ________________________________________________________________________ Notice 08/27/04 69 FR 52710 Regulatory Flexibility Analysis Required: No Government Levels Affected: None Agency Contact: Terri Deutseh Phone: 410 786-9462 Email: tdeutseh@cms.hhs.gov RIN: 0938-AM78 _______________________________________________________________________ 1112. TICKET TO WORK: DEFINING INDIVIDUALS WITH POTENTIALLY SEVERE DISABILITIES AND PROVIDING A WORK THRESHOLD (CMS-2172-P) Priority: Other Significant. Major status under 5 USC 801 is undetermined. CFR Citation: None Completed: ________________________________________________________________________ Reason Date FR Cite ________________________________________________________________________ Withdrawn 06/30/04 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Carey Appold Phone: 410 786-2117 RIN: 0938-AM79 _______________________________________________________________________ 1113. CHANGES TO THE HOSPITAL INPATIENT PROSPECTIVE PAYMENT SYSTEM AND FY 2005 RATES (CMS-1428-F) Priority: Economically Significant. Major under 5 USC 801. CFR Citation: 42 CFR 412; 42 CFR 413; 42 CFR 485; 42 CFR 489 Completed: ________________________________________________________________________ Reason Date FR Cite ________________________________________________________________________ NPRM 05/18/04 69 FR 28195 Correction Notice 06/25/04 69 FR 35920 Final Action 08/11/04 69 FR 48916 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: Federal Agency Contact: Tzvi Hefter Phone: 410 786-4487 RIN: 0938-AM80 _______________________________________________________________________ 1114. COVERED OUTPATIENT DRUGS UNDER THE MEDICAID DRUG REBATE PROGRAM (CMS-2174-P) Priority: Other Significant. Major status under 5 USC 801 is undetermined. CFR Citation: 42 CFR 441 ; 42 CFR 447 Completed: ________________________________________________________________________ Reason Date FR Cite ________________________________________________________________________ Withdrawn 08/10/04 Regulatory Flexibility Analysis Required: No Government Levels Affected: Undetermined Federalism: Undetermined Agency Contact: Marge Watchorn Phone: 410 786-4361 RIN: 0938-AM81 _______________________________________________________________________ 1115. PROSPECTIVE PAYMENT SYSTEM FOR INPATIENT REHABILITATION FACILITIES FOR FY 2005 (CMS-1360-N) Priority: Substantive, Nonsignificant CFR Citation: None Completed: ________________________________________________________________________ Reason Date FR Cite ________________________________________________________________________ Notice 07/30/04 69 FR 45721 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Robert Kuhl Phone: 410 786-4597 RIN: 0938-AM82 _______________________________________________________________________ 1116. PAYMENT ERROR RATE MEASUREMENT (PERM) PROGRAM (CMS-6026-P) Priority: Other Significant. Major under 5 USC 801. CFR Citation: None Completed: ________________________________________________________________________ Reason Date FR Cite ________________________________________________________________________ Withdrawn 05/28/04 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: State Agency Contact: Christine Saxonis Phone: 410 786-3722 Email: csaxonis@cms.hhs.gov RIN: 0938-AM86 _______________________________________________________________________ 1117. HOME HEALTH PROSPECTIVE PAYMENT SYSTEM RATE UPDATE FY 2005 (CMS- 1265-F) Priority: Economically Significant. Major under 5 USC 801. CFR Citation: 42 CFR 484 Completed: ________________________________________________________________________ Reason Date FR Cite ________________________________________________________________________ NPRM 06/02/04 69 FR 31248 Correction Notice 07/03/04 69 FR 45775 Final Action 10/22/04 69 FR 62124 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: None Agency Contact: Randy Throndset Phone: 410 786-0131 RIN: 0938-AM93 _______________________________________________________________________ 1118. REVISIONS TO COST SHARING REGULATIONS (CMS-2144-P) Priority: Other Significant CFR Citation: 42 CFR 447.51 to 447.56 Completed: ________________________________________________________________________ Reason Date FR Cite ________________________________________________________________________ Withdrawn 08/16/04 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: Federal, State Federalism: This action may have federalism implications as defined in EO 13132. [[Page 73180]] Agency Contact: Alissa Deboy Phone: 410 786-6041 RIN: 0938-AM94 _______________________________________________________________________ 1119. MEDICARE PROGRAM; HOSPITAL OUTPATIENT PROSPECTIVE PAYMENT SYSTEM PAYMENT REFORM FOR CALENDAR YEAR 2004 CMS-1371-F Priority: Other Significant. Major under 5 USC 801. CFR Citation: Not Yet Determined Completed: ________________________________________________________________________ Reason Date FR Cite ________________________________________________________________________ Merged With 0938-AM75 11/15/04 Regulatory Flexibility Analysis Required: Undetermined Government Levels Affected: Undetermined Agency Contact: Dana Buley Phone: 410 786-4547 Email: dbuley@cms.hhs.gov RIN: 0938-AM96 _______________________________________________________________________ 1120. CHANGES TO MEDICARE PAYMENT FOR DRUGS AND PHYSICIAN FEE SCHEDULE PAYMENTS FOR CALENDAR YEAR 2004--CORRECTION NOTICE CMS-1372-F) Priority: Economically Significant. Major under 5 USC 801. CFR Citation: 42 CFR 405; 42 CFR 414 Completed: ________________________________________________________________________ Reason Date FR Cite ________________________________________________________________________ Correction 06/25/04 69 FR 35527 Merged With 0938-AM90 11/15/04 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: Federal Agency Contact: Marc Hartstein Phone: 410 786-4539 Email: mhartstein@cms.hhs.gov RIN: 0938-AM97 _______________________________________________________________________ 1121. PHYSICIANS' REFERRALS TO HEALTH CARE ENTITIES WITH WHICH THEY HAVE FINANCIAL RELATIONSHIPS: EXTENSION OF PARTIAL DELAY OF EFFECTIVE DATE (CMS-1809-F5) Priority: Routine and Frequent CFR Citation: None Completed: ________________________________________________________________________ Reason Date FR Cite ________________________________________________________________________ Final Action 07/07/04 69 FR 35529 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Karen Raschke Phone: 410 786-0016 Email: kraschke@cms.hhs.gov Related RIN: Related to 0938-AL29, Related to 0938-AM21, Related to 0938-AM58, Related to 0938-AM95 RIN: 0938-AM99 _______________________________________________________________________ 1122. TIME LIMITATION ON RECORDKEEPING REQUIREMENTS UNDER THE DRUG REBATE PROGRAM (CMS-2188-P) Priority: Other Significant CFR Citation: 42 USC 447.534 Completed: ________________________________________________________________________ Reason Date FR Cite ________________________________________________________________________ Merged With 0938-AN55 08/10/04 Regulatory Flexibility Analysis Required: No Government Levels Affected: Undetermined Federalism: Undetermined Agency Contact: Marge Watchorn Phone: 410 786-4361 Email: mwatchorn@cms.hhs.gov RIN: 0938-AN01 _______________________________________________________________________ 1123. EXTENDED AVAILABILITY OF UNEXPENDED SCHIP FUNDS FROM THE APPROPRIATION FOR FYS 1998 THROUGH 2004; AUTHORITY TO USE A PORTION OF SCHIP FUNDS FOR MEDICAID EXPENDITURES (CMS-2187-N) Priority: Other Significant CFR Citation: None Completed: ________________________________________________________________________ Reason Date FR Cite ________________________________________________________________________ Final Action 07/23/04 69 FR 44013 Regulatory Flexibility Analysis Required: No Small Entities Affected: Governmental Jurisdictions Government Levels Affected: State Agency Contact: Richard Strauss Phone: 410 786-2019 Email: rstrauss@cms.hhs.gov RIN: 0938-AN03 _______________________________________________________________________ 1124. MANUFACTURERS' SUBMISSION OF AVERAGE SALES PRICE DATA FOR MEDICARE PART B DRUGS AND BIOLOGICALS (CMS-1380-F) Priority: Other Significant CFR Citation: None Completed: ________________________________________________________________________ Reason Date FR Cite ________________________________________________________________________ Final Rule 09/16/04 69 FR 55763 Regulatory Flexibility Analysis Required: No Small Entities Affected: Businesses, Governmental Jurisdictions Government Levels Affected: Federal Agency Contact: Angela Mason Phone: 410 786-7452 Email: amason@cms.hhs.gov RIN: 0938-AN05 _______________________________________________________________________ 1125. SPECIAL RULES FOR EMPLOYER-SPONSORED DRUG PROGRAMS: SUBSIDIES TO ENCOURAGE RETENTION (TITLE I) (CMS-2199-P) Priority: Economically Significant. Major under 5 USC 801. CFR Citation: 42 CFR 423 Completed: ________________________________________________________________________ Reason Date FR Cite ________________________________________________________________________ Merged With 0938-AN08 07/23/04 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses, Governmental Jurisdictions, Organizations Government Levels Affected: None Agency Contact: James Mayhew Phone: 410 786-9344 [[Page 73181]] Email: jmayhew@cms.hhs.gov RIN: 0938-AN07 _______________________________________________________________________ 1126. FY 2005 SCHIP ALLOTMENTS (CMS-2201-N) Priority: Economically Significant CFR Citation: 42 CFR 457 Completed: ________________________________________________________________________ Reason Date FR Cite ________________________________________________________________________ Notice 08/27/04 69 FR 52700 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: State Agency Contact: Richard Strauss Phone: 410 786-2019 Email: rstrauss@cms.hhs.gov RIN: 0938-AN11 _______________________________________________________________________ 1127. PART A PREMIUMS FOR CALENDAR YEAR 2005 FOR THE UNINSURED AGED AND FOR CERTAIN DISABLED INDIVIDUALS WHO HAVE EXHAUSTED OTHER ENTITLEMENT (CMS-8022-N) Priority: Economically Significant. Major under 5 USC 801. CFR Citation: None Completed: ________________________________________________________________________ Reason Date FR Cite ________________________________________________________________________ Notice 09/09/04 69 FR 54673 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Clare McFarland Phone: 410 786-6390 Email: cmcfarland@cms.hhs.gov RIN: 0938-AN15 _______________________________________________________________________ 1128. INPATIENT HOSPITAL DEDUCTIBLE AND HOSPITAL AND EXTENDED CARE SERVICES COINSURANCE AMOUNTS FOR CALENDAR YEAR 2005 (CMS-8021-N) Priority: Economically Significant. Major under 5 USC 801. CFR Citation: None Completed: ________________________________________________________________________ Reason Date FR Cite ________________________________________________________________________ Notice 09/09/04 69 FR 54671 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Clare McFarland Phone: 410 786-6390 Email: cmcfarland@cms.hhs.gov RIN: 0938-AN16 _______________________________________________________________________ 1129. MEDICARE PART B MONTHLY ACTUARIAL RATES AND PREMIUM RATE BEGINNING JANUARY 1, 2005 (CMS-8020-N) Priority: Economically Significant. Major under 5 USC 801. CFR Citation: None Completed: ________________________________________________________________________ Reason Date FR Cite ________________________________________________________________________ Notice 09/09/04 69 FR 54674 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Clare McFarland Phone: 410 786-6390 Email: cmcfarland@cms.hhs.gov RIN: 0938-AN18 _______________________________________________________________________ 1130. FEE SCHEDULE FOR PAYMENT OF AMBULANCE SERVICES-UPDATE FOR CALENDAR YEAR 2005 (CMS-1267-N) Priority: Economically Significant. Major under 5 USC 801. CFR Citation: 42 CFR 414.620(f); 42 CFR 414.610(c)(5); 42 CFR 414.615; 42 CFR 414.605 Completed: ________________________________________________________________________ Reason Date FR Cite ________________________________________________________________________ Notice 11/15/04 69 FR 66918 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: None Agency Contact: Ann Tayloe Phone: 410 786-4546 Email: atayloe@cms.hhs.gov RIN: 0938-AN20 _______________________________________________________________________ 1131. PROCEDURE FOR PRODUCING GUIDANCE DOCUMENTS DESCRIBING MEDICARE'S COVERAGE PROCESS (CMS-3141-N) Priority: Info./Admin./Other CFR Citation: None Completed: ________________________________________________________________________ Reason Date FR Cite ________________________________________________________________________ Notice 09/24/04 69 FR 57325 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Vadim Lubarsky Phone: 410 786-0840 Email: vlubarsky@cms.hhs.gov RIN: 0938-AN21 _______________________________________________________________________ 1132. AMENDMENT TO THE INTERIM FINAL REGULATION FOR MENTAL HEALTH PARITY (CMS-2152-F2) Priority: Other Significant CFR Citation: 45 CFR 146.136 Completed: ________________________________________________________________________ Reason Date FR Cite ________________________________________________________________________ Final Action 07/23/04 69 FR 43924 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: David Mlawsky Phone: 410 786-6851 RIN: 0938-AN22 _______________________________________________________________________ 1133. PHARMACY DISPENSING FEE (CMS-1280-F) Priority: Other Significant CFR Citation: None Completed: ________________________________________________________________________ Reason Date FR Cite ________________________________________________________________________ Withdrawn 11/09/04 Regulatory Flexibility Analysis Required: No Government Levels Affected: Undetermined Federalism: Undetermined Agency Contact: Angela Mason Phone: 410 786-7452 Email: amason@cms.hhs.gov RIN: 0938-AN34 [[Page 73182]] _______________________________________________________________________ Department of Health and Human Services (HHS) Proposed Rule Stage Administration for Children and Families (ACF) _______________________________________________________________________ 1134. SAFEGUARDING CHILD SUPPORT AND EXPANDED FEDERAL PARENT LOCATOR SERVICES (FPLS) INFORMATION Priority: Substantive, Nonsignificant Legal Authority: 42 USC 652 to 654A; 42 USC 663; 42 USC 1302 CFR Citation: 45 CFR 303.3; 45 CFR 303.21; 45 CFR 303.70 Legal Deadline: None Abstract: The Personal Responsibility and Work Opportunity Reconciliation Act of 1996 made far-reaching amendments to title IV-D of the Social Security Act, which governs the child support enforcement program. The Balanced Budget Act of 1997, the Adoption and Safe Families Act of 1997, and the Child Support Performance and Incentive Act of 1998 further amended title IV-D. A significant result of this legislation is an expansion in the scope of information available to State IV-D child support enforcement agencies. The legislation has rendered obsolete or inconsistent several regulations at 45 CFR chapter III, Office of Child Support Enforcement, including the regulations on the Federal Parent Locator Service, the State Parent Locator Services, the offset of Federal payments for purposes of collecting child support, and the safeguarding of information. This regulation would update various sections in 45 CFR chapter III to reflect the statutory changes. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 03/00/05 Regulatory Flexibility Analysis Required: No Government Levels Affected: Local, State, Tribal Agency Contact: Elizabeth C. Matheson, Director, Policy and Planning Division, Department of Health and Human Services, Administration for Children and Families, Office of Child Support Enforcement, 370 L'Enfant Promenade SW., Washington, DC 20447 Phone: 202 401-9386 Email: bmatheson@acf.dhhs.gov RIN: 0970-AC01 _______________________________________________________________________ 1135. DEVELOPMENTAL DISABILITIES AND BILL OF RIGHTS ACT Priority: Substantive, Nonsignificant Legal Authority: PL 106-402; 42 USC 15001 et seq CFR Citation: 45 CFR 1385 to 1388 Legal Deadline: Final, Statutory, October 30, 2001. Abstract: A notice of proposed rulemaking will be published in the Federal Register to amend current regulations and to implement changes made by the Developmental Disabilities Assistance and Bill of Rights Act of 2000. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 03/00/05 Regulatory Flexibility Analysis Required: No Small Entities Affected: Governmental Jurisdictions, Organizations Government Levels Affected: Local, State, Tribal Agency Contact: Elsbeth Wyatt, Program Specialist, Department of Health and Human Services, Administration for Children and Families, ADD HHH- 300F, 370 L'Enfant Promenade SW., Washington, DC 20447 Phone: 202 690-5841 RIN: 0970-AC07 _______________________________________________________________________ 1136. ADMINISTRATIVE COSTS FOR CHILDREN IN TITLE IV-E FOSTER CARE Priority: Other Significant Legal Authority: 42 USC 672; 42 USC 674; 42 USC 1302 CFR Citation: 45 CFR 1356.60(c) Legal Deadline: None Abstract: This notice of proposed rulemaking implements the title IV-E foster care eligibility and administrative cost provisions in sections 472 and 474 of the Social Security Act. We propose to prohibit the reimbursement of administrative costs claimed on behalf of children in unlicensed foster family homes, with the exception of children in relative foster family homes while the State is in the process of licensing the home. We also propose to prohibit the reimbursement of administrative costs claimed on behalf of children in unallowable facilities, with the exception of the month prior to a child's transition into an allowable facility. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 12/00/04 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: State Agency Contact: Kathleen McHugh, Divison Director, Children's Bureau Policy, Department of Health and Human Services, Administration for Children and Families, Room 2411, 330 C Street SW., Washington, DC 20447 Phone: 202 401-5789 Fax: 202 205-8221 Email: kmchugh@acf.hhs.gov RIN: 0970-AC14 _______________________________________________________________________ 1137. ADMINISTRATIVE COST SHARING UNDER TANF Priority: Substantive, Nonsignificant Legal Authority: 42 USC 1302 CFR Citation: 45 CFR 263; 45 CFR 263.14 Legal Deadline: None Abstract: This proposed rule will enable States (including the District of Columbia) and territories to use either the ``primary program'' cost allocation methodology previously allowed under the Aid to Families with Dependent Children (AFDC) program to allocate the common administrative costs of determining eligibility in the Temporary Assistance for Needy Families (TANF) program, the Medicaid program, and the Food Stamp programs or to continue to use a ``benefiting'' cost allocation methodology. Pursuant to a determination by Secretary Thompson, States and territories would be able to elect to use their Federal TANF funds to pay for costs that are common to the administration of the TANF, Medicaid, and Food Stamps Programs, in accordance with the primary program cost allocation methodology previously allowed under the former AFDC program. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 03/00/05 Regulatory Flexibility Analysis Required: No [[Page 73183]] Small Entities Affected: No Government Levels Affected: Local, State Agency Contact: April Kaplan, Deputy Director, Office of Family Assistance, Department of Health and Human Services, Administration for Children and Families, 5th Floor East, 370 L'Enfant Promenade SW., Washington, DC 20447 Phone: 202 401-5138 Email: akaplan@acf.hhs.gov RIN: 0970-AC15 _______________________________________________________________________ 1138. CHILD CARE AND DEVELOPMENT FUND STATE MATCH PROVISIONS Priority: Other Significant Legal Authority: 42 USC 9858C CFR Citation: 45 CFR 98.16 Legal Deadline: None Abstract: This proposed rule revises the Child Care and Development Fund (CCDF) regulations to permit States to designate multiple public and/or private entities as eligible to receive private donations that may be certified as child care expenditures for purposes of receiving Federal CCDF matching funds. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 11/09/04 69 FR 64881 Final Action To Be Determined Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: Local, State Agency Contact: Karen Tvedt, Policy Director, Child Care Bureau, Department of Health and Human Services, Administration for Children and Families, 330 C Street SW., Room 2046, Washington, DC 20447 Phone: 202 401-5130 Email: ktvedt@acf.hhs.gov RIN: 0970-AC18 _______________________________________________________________________ Department of Health and Human Services (HHS) Final Rule Stage Administration for Children and Families (ACF) _______________________________________________________________________ 1139. HEAD START TRANSPORTATION Priority: Other Significant. Major status under 5 USC 801 is undetermined. Legal Authority: 42 USC 9801 et seq CFR Citation: 45 CFR 1310 Legal Deadline: None Abstract: This final rule will extend for 150 days those parts of the Head Start transportation regulation that deal with the requirement that each vehicle used to transport children is equipped for use of child safety restraint systems and the requirement that each bus have a bus monitor. Additionally, these rules will provide Head Start grantees the opportunity to request further extension of the effective date when such an extension is in the best interest of the children they serve. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Interim Final Rule 01/16/04 69 FR 2513 Final Action 03/00/05 Regulatory Flexibility Analysis Required: No Government Levels Affected: None Agency Contact: Windy Hill, Associate Commisioner, Head Start Bureau, Department of Health and Human Services, 330 C Street SW., Washington, DC 20447 Phone: 202 205-8573 Email: whill@acf.hhs.gov RIN: 0970-AC16 _______________________________________________________________________ 1140. REASONABLE QUANTITATIVE STANDARD FOR REVIEW AND ADJUSTMENT OF CHILD SUPPORT ORDERS Priority: Other Significant. Major status under 5 USC 801 is undetermined. Legal Authority: 42 USC 1302 CFR Citation: 45 CFR 303 Legal Deadline: None Abstract: This interim final rule permits States to use reasonable quantitative standards in adjusting an existing child support award amount after conducting review of the order, regardless of the method review. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Interim Final Rule 12/00/04 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: Local, State Agency Contact: Elizabeth C. Matheson, Director, Policy and Planning Division, Department of Health and Human Services, Administration for Children and Families, Office of Child Support Enforcement, 370 L'Enfant Promenade SW., Washington, DC 20447 Phone: 202 401-9386 Email: bmatheson@acf.dhhs.gov RIN: 0970-AC19 [[Page 73184]] _______________________________________________________________________ Department of Health and Human Services (HHS) Completed Actions Administration for Children and Families (ACF) _______________________________________________________________________ 1141. CHILD SUPPORT ENFORCEMENT PROGRAM; FEDERAL TAX REFUND OFFSET Priority: Other Significant CFR Citation: 45 CFR 303.72 Completed: ________________________________________________________________________ Reason Date FR Cite ________________________________________________________________________ Final Action 10/26/04 69 FR 62413 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: State Agency Contact: Elizabeth C. Matheson Phone: 202 401-9386 Email: bmatheson@acf.dhhs.gov RIN: 0970-AC09 _______________________________________________________________________ Department of Health and Human Services (HHS) Proposed Rule Stage Administration on Aging (AOA) _______________________________________________________________________ 1142. GRANTS FOR STATE AND COMMUNITY PROGRAMS ON AGING, TRAINING, RESEARCH, AND DISCRETIONARY PROGRAMS; VULNERABLE ELDER RIGHTS; GRANTS TO INDIANS AND NATIVE HAWAIIANS Priority: Substantive, Nonsignificant Legal Authority: 42 USC 3001 et seq CFR Citation: 45 CFR 1321; 45 CFR 1326; 45 CFR 1328 Legal Deadline: None Abstract: In response to the reauthorization of the Older Americans Act, Public Law 106-501, the Administration on Aging (AoA) proposes to issue a notice of proposed rulemaking by February 2005. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 02/00/05 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses, Governmental Jurisdictions Government Levels Affected: State, Tribal Federalism: Undetermined Agency Contact: Edwin Walker, Deputy Assistant Secretary for Policy and Programs, Department of Health and Human Services, Administration on Aging, Washington, DC 20201 Phone: 202 401-4634 RIN: 0985-AA00 [FR Doc. 04-25762 Filed 12-10-04; 8:45 am] BILLING CODE 4150-24-S