<DOC>
[October 31,2005  (Volume 70, Number 209)]
[Unified Agenda]
From the Federal Register Online via GPO Access [frwais.access.gpo.gov]
[DOCID: f:ua051008.wais]
[Page 64554-64628]
Department of Health and Human Services
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Part VIII
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Semiannual Regulatory Agenda
[[Page 64554]]
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 Regulatory Agenda.
_______________________________________________________________________
SUMMARY: The Regulatory Flexibility Act of 1980 and Executive Order
12866 require this semi-annual publication inventorying the 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 our consideration. Members of the public
wishing to communicate to the Department their views on the potential
rule-makings outlined below are invited to do so.
FOR FURTHER INFORMATION CONTACT: Ann C. Agnew, Executive Secretary,
Department of Health and Human Services, Washington, D.C. 20201.
SUPPLEMENTARY INFORMATION:  The capsulized information provided below
presents for public scrutiny a forecast of the rulemaking activities
that the Department expects to undertake over the foreseeable future.
We focus primarily on those areas of work expected to result in
publication of Notices of Proposed Rulemaking or Final Rules within the
next 12 months.
     We welcome the views of all concerned with regard to these
planned rulemakings. Comments may be directed to the agency
officials cited in each of the summaries, or, if early attention at
the Secretary's level is seen as required, comments should be sent
to: Ann C. Agnew, Executive Secretary to the Department, Room 603H,
200 Independence Avenue, SW., Washington DC 20201.
Dated: September 29, 2005
 Ann C. Agnew,
Executive Secretary to the Department.
                                  Office of the Secretary--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
985         Revisions to Regulations Addressing the OIG's Authority To Impose Civil Money             0991-AB03
            Penalties and Assessments.............................................................
986         Medicare and State Health Care Programs: Fraud and Abuse; Safe Harbor for Certain         0991-AB39
            Electronic Prescribing Arrangements Under the Anti-Kickback Statute...................
----------------------------------------------------------------------------------------------------------------
                                    Office of the Secretary--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
987         Shared Risk Exception to the Safe Harbor Provisions...................................    0991-AA91
988         Safe Harbor for Waiver of Beneficiary Coinsurance and Deductible Amounts for a            0991-AB16
            Medicare SELECT Policy................................................................
989         Clarification of Terms and Application of Program Exclusion Authority for Submitting      0991-AB23
            Claims Containing Excessive Charges...................................................
990         Health Insurance Portability and Accountability Act--Enforcement......................    0991-AB29
991         Medicare and State Health Care Programs: Fraud and Abuse; Safe Harbor for Federally       0991-AB38
            Qualified Health Centers Under the Anti-Kickback Statute..............................
----------------------------------------------------------------------------------------------------------------
                                   Office of the Secretary--Long-Term Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
992         Claims Collection.....................................................................    0991-AB18
993         Salary Offset.........................................................................    0991-AB19
994         Revisions to the Waiver Provisions of the Office of Inspector General's (OIG)             0991-AB33
            Exclusion Authorities.................................................................
----------------------------------------------------------------------------------------------------------------
                                   Office of the Secretary--Completed Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
995         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...............................................................................
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[[Page 64555]]
                 Substance Abuse and Mental Health Services Administration--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
996         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
----------------------------------------------------------------------------------------------------------------
997         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
----------------------------------------------------------------------------------------------------------------
998         Amendments to Quality Assurance and Administrative Provision for Approval of              0920-AA04
            Respiratory Protective Devices........................................................
999         Amendments to Self-Contained Breathing Apparatus Requirements for Approval of             0920-AA10
            Respiratory Protective Devices........................................................
1000        Control of Communicable Diseases, Interstate and Foreign Quarantine (Reg Plan Seq No.     0920-AA12
            42)...................................................................................
----------------------------------------------------------------------------------------------------------------
References in boldface appear in the Regulatory Plan in part II of this issue of the Federal Register.
                          Centers for Disease Control and Prevention--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
1001        Procedures for Designating Classes of Employees as Members of the Special Exposure        0920-AA13
            Cohort Under the Energy Employees Occupational Illness Compensation Program Act of
            2000; Amendments......................................................................
----------------------------------------------------------------------------------------------------------------
                                   Food and Drug Administration--Prerule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
1002        Medical Devices; Current Good Manufacturing Practice (CGMP) Final Rule; Quality           0910-AF71
            Systems Regulations (Section 610 Review)..............................................
----------------------------------------------------------------------------------------------------------------
                                Food and Drug Administration--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
1003        Foreign and Domestic Establishment Registration and Listing Requirements for Human        0910-AA49
            Drugs, Including Drugs That Are Regulated Under a Biologics License Application, and
            Animal Drugs (Reg Plan Seq No. 43)....................................................
1004        Chronic Wasting Disease: Control of Food Products and Cosmetics Derived From Exposed      0910-AC21
            Animal Populations....................................................................
1005        Medical Devices; Anesthesiology Devices; Proposed Reclassification of Pressure            0910-AC30
            Regulators for Use With Medical Oxygen................................................
1006        Submission of Standardized Electronic Study Data From Clinical Studies Evaluating         0910-AC52
            Human Drugs and Biologics (Reg Plan Seq No. 44).......................................
1007        Medical Gas Containers and Closures; Current Good Manufacturing Practice Requirements.    0910-AC53
1008        Positron Emission Tomography Drugs; Current Good Manufacturing Practices..............    0910-AC55
1009        Reporting Information Regarding Falsification of Data.................................    0910-AC59
1010        Content and Format of Labeling for Human Prescription Drugs and Biologics;                0910-AF11
            Requirements for Pregnancy and Lactation Labeling (Reg Plan Seq No. 45)...............
1011        Cochineal Extract and Carmine Label Declaration.......................................    0910-AF12
[[Page 64556]]
1012        Charging for Investigational Drugs....................................................    0910-AF13
1013        Expanded Access to Investigational Drugs for Treatment Use (Reg Plan Seq No. 46)......    0910-AF14
1014        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.............................................................
1015        Revocation of the Status of Specific Products; Group A Streptococcus..................    0910-AF20
1016        Obstetrical and Gynecological Devices; Designation of Special Control for Condoms and     0910-AF21
            Condoms With Spermicidal Lubricant....................................................
1017        Blood Initiative--Requirements for Human Blood and Blood Components Intended for          0910-AF25
            Transfusion or for Further Manufacturing Use..........................................
1018        Over-the-Counter (OTC) Drug Review--Internal Analgesic Products.......................    0910-AF36
1019        Over-the-Counter (OTC) Drug Review--Labeling of Drug Products for OTC Human Use.......    0910-AF37
1020        Over-the-Counter (OTC) Drug Review--Ophthalmic Products...............................    0910-AF39
1021        Over-the-Counter (OTC) Drug Review--Sunscreen Products................................    0910-AF43
1022        Over-the-Counter (OTC) Drug Review--Weight Control Products...........................    0910-AF45
1023        Substances Prohibited From Use in Animal Food or Feed.................................    0910-AF46
1024        Over-the-Counter (OTC) Drug Review--Dandruff, Seborrheic Dermatitis, and Psoriasis        0910-AF49
            Products..............................................................................
1025        Over-the-Counter (OTC) Drug Review--Skin Bleaching Products...........................    0910-AF53
1026        Over-the-Counter (OTC) Drug Review--Stimulant Drug Products...........................    0910-AF56
1027        Designation of New Animal Drugs for Minor Use and Minor Species.......................    0910-AF60
1028        Blood Vessels Recovered With Organs and Intended for Use in Organ Transplantation.....    0910-AF65
1029        Index of Legally Marketed Unapproved New Animal Drugs for Minor Species...............    0910-AF67
1030        Over-the-Counter (OTC) Drug Review--Poison Treatment Drug Products....................    0910-AF68
1031        Over-the-Counter (OTC) Drug Review--Topical Antimicrobial Drug Products...............    0910-AF69
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
1032        Investigational New Drugs: Export Requirements for Unapproved New Drug Products.......    0910-AA61
1033        Requirements on Content and Format of Labeling for Human Prescription Drugs and           0910-AA94
            Biological Products (Reg Plan Seq No. 47).............................................
1034        Safety Reporting Requirements for Human Drug and Biological Products..................    0910-AA97
1035        Applications for FDA Approval To Market a New Drug; Complete Response Letter;             0910-AB34
            Amendments To Unapproved Applications.................................................
1036        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)..................................................................
1037        Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Dietary         0910-AB88
            Ingredients and Dietary Supplements (Reg Plan Seq No. 48).............................
1038        Additional Safeguards for Children in Clinical Investigations of FDA-Regulated            0910-AC07
            Products..............................................................................
1039        Prevention of Salmonella Enteritidis in Shell Eggs....................................    0910-AC14
1040        Institutional Review Boards: Registration Requirements................................    0910-AC17
1041        Exception From General Requirements for Informed Consent; Request for Comments and        0910-AC25
            Information...........................................................................
1042        Medical Devices; Patient Examination and Surgeons' Gloves; Adulteration...............    0910-AC32
1043        Toll-Free Number for Reporting Adverse Events on Labeling for Human Drugs (Reg Plan       0910-AC35
            Seq No. 49)...........................................................................
1044        Prior Notice of Imported Food Under the Public Health Security and Bioterrorism           0910-AC41
            Preparedness and Response Act of 2002.................................................
1045        Human Subject Protection; Foreign Clinical Studies Not Conducted Under an                 0910-AF15
            Investigational New Drug Application..................................................
1046        Blood Initiative--Revisions to Labeling Requirements for Blood and Blood Components,      0910-AF26
            Including Source Plasma; and Technical Amendment......................................
1047        Infant Formula: Current Good Manufacturing Practices; Quality Control Procedures;         0910-AF27
            Notification Requirements; Records and Reports........................................
1048        Infant Formula Quality Factors........................................................    0910-AF28
1049        Over-the-Counter (OTC) Drug Review--Cough/Cold (Antihistamine) Products...............    0910-AF31
1050        Over-the-Counter (OTC) Drug Review--Cough/Cold (Nasal Decongestant) Products..........    0910-AF34
1051        Over-the-Counter (OTC) Drug Review--Laxative Drug Products............................    0910-AF38
[[Page 64557]]
1052        Over-the-Counter (OTC) Drug Review--Skin Protectant Products..........................    0910-AF42
1053        Over-the-Counter (OTC) Drug Review--Vaginal Contraceptive Products....................    0910-AF44
1054        Use of Materials Derived From Cattle in Human Food and Cosmetics......................    0910-AF47
1055        Recordkeeping Requirements for Human Food and Cosmetics Manufactured From, Processed      0910-AF48
            With, or Otherwise Containing Material From Cattle....................................
1056        Over-the-Counter (OTC) Drug Review--Antacid Products..................................    0910-AF52
1057        Supplements and Other Changes to Approved New Animal Drug Applications................    0910-AF59
1058        Biological Products; Bacterial Vaccines and Toxoids; Implementation of Efficacy Review    0910-AF62
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
1059        Requirements for Submission of In Vivo Bioequivalence Data............................    0910-AC23
1060        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.....
1061        Food Standards: General Principles and Food Standards Modernization...................    0910-AC54
1062        Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding     0910-AF08
            of Drugs; Revision of Certain Labeling Controls.......................................
1063        Health Claims.........................................................................    0910-AF09
1064        Food Labeling; Prominence of Calories.................................................    0910-AF22
1065        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....................................................
1066        Over-the-Counter (OTC) Drug Review--Cough/Cold (Bronchodilator) Products..............    0910-AF32
1067        Over-the-Counter (OTC) Drug Review--Cough/Cold (Combination) Products.................    0910-AF33
1068        Over-the-Counter (OTC) Drug Review--External Analgesic Products.......................    0910-AF35
1069        Over-the-Counter (OTC) Drug Review--Oral Health Care Products.........................    0910-AF40
1070        Over-the-Counter (OTC) Drug Review--Overindulgence in Food and Drink Products.........    0910-AF51
1071        Use of Materials Derived From Cattle in Medical Products Intended for Use in Humans       0910-AF54
            and Drugs Intended for Use in Ruminants...............................................
1072        Label Requirement for Food That Has Been Refused Admission Into the United States.....    0910-AF61
1073        Over-the-Counter Antidiarrheal Drug Products..........................................    0910-AF63
1074        Lowfat and Skim Milk and Lowfat and Nonfat Yogurt Products, Lowfat Cottage Cheese:        0910-AF64
            Rev. of Stand. of Ident.; Food Lab., Nutrient Cont. Claims for Fat, Fatty Acids, and
            Cholesterol Cont. of Foods (Section 610 Review).......................................
1075        Over-the-Counter (OTC) Drug Review--Urinary Analgesic Drug Products...................    0910-AF70
----------------------------------------------------------------------------------------------------------------
                                 Food and Drug Administration--Completed Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
1076        Requirements Pertaining to Sampling Services and Private Laboratories Used in             0910-AB96
            Connection With Imported Food.........................................................
1077        Amendments to the Performance Standard for Diagnostic X-Ray Systems and Their Major       0910-AC34
            Components............................................................................
1078        Registration of Food and Animal Feed Facilities.......................................    0910-AC40
1079        Quality Standard Regulation Establishing an Allowable Level for Arsenic in Bottled        0910-AF10
            Water.................................................................................
----------------------------------------------------------------------------------------------------------------
                        Health Resources and Services Administration--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
1080        Designation of Medically Underserved Populations and Health Professional Shortage         0906-AA44
            Areas.................................................................................
1081        National Practitioner Data Bank for Adverse Information on Physicians and Other Health    0906-AA57
            Care Practitioners: Reporting Adverse and Negative Actions............................
[[Page 64558]]
1082        Intestines Added to the Definition of Organs Covered by the Rules Governing the           0906-AA62
            Operation of the Organ Procurement and Transplantation Network (OPTN).................
1083        National Vaccine Injury Compensation Program: Calculation of Average Cost of a Health     0906-AA68
            Insurance Policy......................................................................
1084        Healthy Tomorrow's Partnership for Children (HTPC) Program............................    0906-AA70
----------------------------------------------------------------------------------------------------------------
                         Health Resources and Services Administration--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
1085        Interim Final Rule for the Smallpox Emergency Personnel Protection Program: Smallpox      0906-AA60
            (Vaccinia) Vaccine Injury Table.......................................................
1086        Smallpox Vaccine Injury Compensation Program: Administrative Implementation...........    0906-AA61
1087        Requirements Establishing a Limitation on Administrative Expenses; Ryan White CARE Act    0906-AA65
            Title IV Grants for Coordinated Services and Access to Research.......................
1088        Revision to 42 CFR Subpart D--Public Health Service (PHS) Grant Appeals Procedure.....    0906-AA69
----------------------------------------------------------------------------------------------------------------
                         Health Resources and Services Administration--Long-Term Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
1089        National Practitioner Data Bank for Adverse Information on Physicians and Other Health    0906-AA41
            Care Practitioners: Medical Malpractice Payments Reporting Requirements...............
1090        Operation of the Organ Procurement and Transplantation Network (OPTN).................    0906-AA63
----------------------------------------------------------------------------------------------------------------
                                   Indian Health Service--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
1091        Section 506--Limitation on Charges for Services Furnished by Medicare Participating       0917-AA07
            Inpatient Hospital to Indians.........................................................
----------------------------------------------------------------------------------------------------------------
                               National Institutes of Health--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
1092        Grants for Research Projects -- 42 CFR Part 52-NPRM...................................    0925-AA42
1093        National Institutes of Health Loan Repayment Programs.................................    0925-AA43
1094        National Library of Medicine Training Grants..........................................    0925-AA44
1095        Minority Biomedical Research Support Program..........................................    0925-AA45
1096        National Institute of Environmental Health Sciences Hazardous Substances Basic            0925-AA46
            Research and Training Grants..........................................................
----------------------------------------------------------------------------------------------------------------
                                 National Institutes of Health--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
1097        National Institutes of Health Training Grants.........................................    0925-AA28
1098        Standards for a National Chimpanzee Sanctuary System..................................    0925-AA31
----------------------------------------------------------------------------------------------------------------
[[Page 64559]]
                                National Institutes of Health--Completed Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
1099        Undergraduate Scholarship Program Regarding Professions Needed by the National            0925-AA10
            Institutes of Health (NIH)............................................................
1100        National Institutes of Health Loan Repayment Program for Research Generally...........    0925-AA18
1101        National Institutes of Health AIDS Research Loan Repayment Program....................    0925-AA32
1102        National Institutes of Health Extramural Loan Repayment Program for Clinical              0925-AA33
            Researchers...........................................................................
1103        National Institutes of Health Pediatric Research Loan Repayment Program...............    0925-AA34
1104        National Institutes of Health Loan Repayment Program for Health Disparities Research..    0925-AA35
1105        National Institutes of Health Clinical Research Loan Repayment Program for Individuals    0925-AA36
            From Disadvantaged Backgrounds........................................................
1106        National Institute of Child Health and Human Development Contraception and Infertility    0925-AA41
            Research Loan Repayment Program.......................................................
----------------------------------------------------------------------------------------------------------------
                               Office of Public Health and Science--Prerule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
1107        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
----------------------------------------------------------------------------------------------------------------
1108        Public Health Service Standards for the Protection of Research Misconduct                 0940-AA01
            Whistleblowers........................................................................
1109        Human Subjects Protection Regulations: Institutional Review Boards Registration           0940-AA06
            Requirements..........................................................................
1110        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
----------------------------------------------------------------------------------------------------------------
1111        Human Subjects Protection Regulations: Training and Ed. Requirements for Institutional    0940-AA08
            Officials, Institutional Review Board Members and Staff, Human Protections
            Administrators, and Investigators.....................................................
----------------------------------------------------------------------------------------------------------------
                             Office of Public Health and Science--Completed Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
1112        Public Health Service Policies on Research Misconduct.................................    0940-AA04
----------------------------------------------------------------------------------------------------------------
                             Centers for Medicare & Medicaid Services--Prerule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
1113        Innovations in Fee-for-Service Payment Systems to Improve Quality and Outcomes (CMS-      0938-AN91
            1298-ANPR) (Reg Plan Seq No. 50)......................................................
----------------------------------------------------------------------------------------------------------------
References in boldface appear in the Regulatory Plan in part II of this issue of the Federal Register.
[[Page 64560]]
                          Centers for Medicare & Medicaid Services--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
1114        Home Health Agency (HHA) Conditions of Participation (CoPs) (CMS-3819-P) (Section 610     0938-AG81
            Review)...............................................................................
1115        Standard Unique National Health Plan Identifier (CMS-6017-P)..........................    0938-AH87
1116        Appeals of Carrier Determinations That a Supplier Fails To Meet the Requirements for      0938-AI49
            Medicare Billing Privileges (CMS-6003-P2).............................................
1117        Rural Health Clinics: Amendments to Participation Requirements and Payment Provisions     0938-AJ17
            and Establishment of a Quality Assessment and Improvement Program (CMS-1910-P2).......
1118        Use of Restraints and Seclusion in Medicare and Medicaid Participating Facilities That    0938-AL26
            Provide Inpatient or Residential Care (CMS-2130-P)....................................
1119        Revisions to Conditions for Coverage for Ambulatory Surgical Centers (CMS-3887-P).....    0938-AL80
1120        Modifications to Electronic Transactions and Code Sets (CMS-0009-P)...................    0938-AM50
1121        Requirements for Long-Term Care Facilities: Hospice Services (CMS-3140-P).............    0938-AM87
1122        Competitive Acquisition for Certain Durable Medical Equipment (DME), Prosthetics,         0938-AN14
            Orthotics, and Supplies and Residual Issues (CMS-1270-P) (Reg Plan Seq No. 51)........
1123        Revisions to HIPAA Code Sets (CMS-0013-P).............................................    0938-AN25
1124        Payment for Clinical Laboratory Tests (CMS-1494-P)....................................    0938-AN26
1125        Termination of Non-Random Prepayment Medical Review (CMS-6022-F)......................    0938-AN31
1126         Limitation on Recoupment of Overpayments (CMS-6025-P)................................    0938-AN42
1127        Revisions to the Oversight and Validation Program for Accrediting Organizations           0938-AN62
            Approved for Deeming Authority (CMS-2255-P)...........................................
1128        Physicians' Referrals to Health Care Entities With Which They Have Financial              0938-AN69
            Relationships; Exceptions for Certain Electronic Prescribing and Electronic Health
            Records Arrangements (CMS-1303-F).....................................................
1129        National Plan and Provider Enumeration System (NPPES) Data Dissemination (CMS-6060-PN)    0938-AN71
1130        Changes to the Disclosure of Information Requirements for Quality Improvement             0938-AN73
            Organizations (CMS-3156-P)............................................................
1131        Home Health Payment System Rate Update for Calendar Year 2007 (CMS-1304-P)............    0938-AN76
1132        Fire Safety Requirements for Long-Term Care Facilities: Sprinkler Systems (CMS-3191-P)    0938-AN79
1133        Inpatient Psychiatric Facility Prospective Payment System--Update for 2006 (CMS-1306-     0938-AN82
            P)....................................................................................
1134        Prospective Payment System for Long-Term Care Hospitals FY 2007: Annual Payment Rate      0938-AO06
            Updates (CMS-1485-P)..................................................................
1135        Payments for Service Provided Without Charge (CMS-2489-P).............................    0938-AO07
1136        Revisions to Payment of Ambulance Services under Medicare (CMS-1317-P)................    0938-AO11
1137        Changes to the Hospital Inpatient Prospective Payment Systems and FY 2007 Rates (CMS-     0938-AO12
            1488-P) (Reg Plan Seq No. 52).........................................................
1138        Revised Payment System for Services Furnished in Ambulatory Surgical Centers (ASCs)       0938-AO13
            Effective January 1, 2008 (CMS-1517-P)................................................
1139        Changes to the Hospital Outpatient Prospective Payment System and Calendar Year 2007      0938-AO15
            Payment Rates (CMS-1506-P)............................................................
1140        Prospective Payment System for Inpatient Rehabilitation Facilities for FY 2007 (CMS-      0938-AO16
            1540-P)...............................................................................
1141        Outpatient Hospital Services and Rural Health Clinic Services Amendment (CMS-2213-P)..    0938-AO17
1142        Five Year Review of Work Relative Value Units Under the Physician Fee Schedule (CMS-      0938-AO22
            1512-PN)..............................................................................
1143        Revisions to Payment Policies Under the Physician Fee Schedule for Calendar Year 2007     0938-AO24
            (CMS-1321-P)..........................................................................
1144        Use of Repayment Plans (CMS-6032-P)...................................................    0938-AO27
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
1145        Requirements for Establishing and Maintaining Medicare Billing Privileges (CMS-6002-F)    0938-AH73
1146        Hospital Conditions of Participation: Laboratory Services (CMS-3014-IFC) (Section 610     0938-AJ29
            Review)...............................................................................
1147        Medicare Hospice Care Amendments (CMS-1022-F).........................................    0938-AJ36
1148        Use of Restraint and Seclusion in Residential Treatment Facilities Providing Inpatient    0938-AJ96
            Psychiatric Services to Individuals Under Age 21 (CMS-2065-F).........................
1149        Organ Procurement Organization Conditions for Coverage (CMS-3064-IFR) (Section 610        0938-AK81
            Review) (Reg Plan Seq No. 53).........................................................
1150        Payment for Respiratory Assist Devices With Bi-Level Capability and a Back-Up Rate        0938-AN02
            (CMS-1167-F)..........................................................................
1151        Enhanced DSH Treatment for Certain Hospitals (CMS-2198-F).............................    0938-AN09
1152        Update of the List of Covered Procedures for Ambulatory Surgical Centers for 2005 (CMS-   0938-AN23
            1478-IFC).............................................................................
[[Page 64561]]
1153        Medicare Secondary Payer Amendments (CMS-6272-IFC)....................................    0938-AN27
1154        Home Health Prospective Payment System Rate Update for Calendar Year 2006 (CMS-1301-F)    0938-AN44
1155        Changes to the Hospital Outpatient Prospective Payment System and Calendar Year 2006      0938-AN46
            Payment Rates (CMS-1501-FC) (Reg Plan Seq No. 54).....................................
1156        All Provider Bad Debt Payment (CMS-1126-F)............................................    0938-AN75
1157        Payment Error Rate Measurement (PERM) Program (CMS-6026-F)............................    0938-AN77
1158        Revisions to Payment Policies Under the Physician Fee Schedule for Calendar Year 2006     0938-AN84
            (CMS-1502-FC) (Reg Plan Seq No. 55)...................................................
1159        Fee Schedule for Payment of Ambulance Services -- Update for CY 2006 (CMS-1294-N).....    0938-AN99
1160        State Allotments for Payment of Medicare Part B Premiums for Qualifying Individuals       0938-AO04
            (CMS-2210-F)..........................................................................
1161        Federal Government's Adoption of Twenty (20) Healthcare Messaging and Vocabulary          0938-AO05
            Standards Recommended by the Consolidated Health Informatics Initiative (CMS-0015-N)..
1162        Fire Safety Requirements for Religious Non-Medical Health Care Institutions:              0938-AO14
            Correction to Add Written Fire Control Plans & Maintenance of Documentation (CMS-3183-
            IFC)..................................................................................
1163        Part A Premiums for Calendar Year 2007 for the Uninsured Aged and for Certain Disabled    0938-AO18
            Individuals Who Have Exhausted Other Entitlement (CMS-8028-N).........................
1164        Inpatient Hospital Deductible and Hospital and Extended Care Services Coinsurance         0938-AO19
            Amounts for Calendar Year 2007 (CMS-8029-N)...........................................
1165        Fiscal Year 2007 SCHIP Allotments (CMS-2251-N)........................................    0938-AO21
1166        Part B Monthly Actuarial Rates and Premium Rate Beginning January 1, 2007 (CMS-8030-N)    0938-AO23
1167        Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities--      0938-AO25
            Update for FY 2007 (CMS-1530-N).......................................................
1168        Hospice Wage Index for FY 2007 (CMS-1535-N)...........................................    0938-AO26
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
1169        End Stage Renal Disease (ESRD) Conditions for Coverage (CMS-3818-F) (Section 610          0938-AG82
            Review)...............................................................................
1170        Hospital Conditions of Participation: Requirements for Approval and Re-approval of        0938-AH17
            Transplant Centers To Perform Organ Transplants (CMS-3835-F)..........................
1171        Hospice Care--Conditions of Participation (CMS-3844-F) (Section 610 Review)...........    0938-AH27
1172        Medicare Outcome and Assessment Information Set (OASIS) Data Reporting Requirements       0938-AJ10
            (CMS-3006-F)..........................................................................
1173        Standards for Electronic Health Care Claim Attachments (CMS-0050-P)...................    0938-AK62
1174        Physicians' Referrals to Health Care Entities With Which They Have Financial              0938-AK67
            Relationships (CMS-1810-F)............................................................
1175        Provider Reimbursement Determinations and Appeals (CMS-1727-F)........................    0938-AL54
1176        Health Coverage Portability: Tolling Certain Time Periods and Interactions With Family    0938-AL88
            and Medical Leave Act (CMS-2158-F)....................................................
1177        Electronic Medicare Claims Submission (CMS-0008-F)....................................    0938-AM22
1178        Requirements for Long-Term Care Facilities; Nursing Services; Posting of Nurse            0938-AM55
            Staffing Information (CMS-3121-F).....................................................
1179        Revisions to the Appeals Process for Initial Claim Determinations (CMS-4064-F)........    0938-AM73
1180        Conditions for Coverage of Power Mobility Devices, Including Powered Wheelchairs and      0938-AM74
            Power-Operated Vehicles Scooter (CMS-3017-F)..........................................
1181        Hospital Conditions of Participation: Requirements for History and Physical               0938-AM88
            Examinations; Authentication of Verbal Orders; Securing Medications; and Post-
            Anesthesia Evaluations (CMS-3122-F)...................................................
1182        Revised Civil Money Penalties, Assessments, Exclusions, and Related Appeals Procedures    0938-AM98
            (CMS-6146-F)..........................................................................
1183        Prior Determination Process for Certain Items and Services (CMS-6024-P)...............    0938-AN10
1184        Nondiscrimination in Health Coverage and Wellness Plans in the Group Market (CMS-4081-    0938-AN29
            F)....................................................................................
1185        Hospital Conditions of Participation: Patients' Rights (CMS-3018-F)...................    0938-AN30
1186        Federal Enforcement in Group and Individual Health Insurance Markets (CMS-4091-F).....    0938-AN35
1187        Fire Safety Requirements for Certain Health Care Facilities; Alcohol-Based Hand           0938-AN36
            Sanitizer Amendment (CMS-3145-F)......................................................
1188        Revised Civil Money Penalties, Assessments, Exclusions, and Related Appeals Procedures    0938-AN48
            (CMS-6019-F)..........................................................................
1189        Electronic Prescribing Standards (CMS-0011-F).........................................    0938-AN49
1190        Medicare Part B Competitive Acquisition of Outpatient Drugs and Biologicals (CMS-1325-    0938-AN58
            F)....................................................................................
[[Page 64562]]
1191        Group Market Health Insurance Reform: Guaranteed Availability, Guaranteed                 0938-AN60
            Renewability, Disclosures to Small Employers (CMS-4102-F).............................
1192        Individual Market Health Insurance Reform: Portability From Group to Individual           0938-AN61
            Coverage; Federal Rules for Access in the Individual Market; State Alternative
            Mechanisms to Federal Rules (CMS-4103-F)..............................................
1193        Medicare Integrity Program, Fiscal Intermediary and Carrier Functions, and Conflict of    0938-AN72
            Interest Requirements (CMS-6030-F)....................................................
1194        Application of Inherent Reasonableness to All Medicare Part B Services (Other than        0938-AN81
            Physician Services) (CMS-1908-F)......................................................
1195        Program for All-Inclusive Care for the Elderly (PACE): Program Revisions (CMS-1201-F).    0938-AN83
1196        Electronic Submission of Cost Reports: Revision to Cost Reporting Period (CMS-1199-F).    0938-AN87
1197        Loan Forgiveness Criteria for the Health Care Infrastructure Loan Program (CMS-1320-F)    0938-AN93
1198        Health Care Infrastructure Improvement Program; Selection Criteria of Loan Program for    0938-AO03
            Qualifying Hospitals Engaged in Cancer-Related Health Care (CMS-1287-F)...............
1199        Medical Improvement Eligibility Group and Definition of Work (CMS-2143-P).............    0938-AO10
----------------------------------------------------------------------------------------------------------------
                           Centers for Medicare & Medicaid Services--Completed Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
1200        Supplier Standards for Home Oxygen, Therapeutic Shoes, and Home Nutrition Therapy (CMS-   0938-AJ98
            6010-P)...............................................................................
1201        Evaluation Criteria and Standards for Quality Improvement Program Contracts (CMS-3142-    0938-AN13
            FN)...................................................................................
1202        Nondiscrimination In Post-Hospital Referral to Home Health Agencies and Other Entities    0938-AN19
            (CMS-1224-F)..........................................................................
1203        Medicare Ambulance Fee Schedule Update (CMS-1492-IFC).................................    0938-AN24
1204        Prospective Payment System for Long Term Care Hospitals: Annual Payment Rate Updates      0938-AN28
            and Policy Changes for 2006 (CMS-1483-F)..............................................
1205        Prospective Payment System for Inpatient Rehabilitation Facilities for FY 2006 (CMS-      0938-AN43
            1290-F)...............................................................................
1206        Development of New Standards for Medigap Policies (CMS-4087-FN).......................    0938-AN50
1207        Fiscal Year 2006 SCHIP Allotments (CMS-2219-N)........................................    0938-AN56
1208        Changes to the Hospital Inpatient Prospective Payment System and FY 2006 Rates (CMS-      0938-AN57
            1500-F)...............................................................................
1209        Special Payment Provisions and Standards for Suppliers of Custom Fabricated Orthotics     0938-AN63
            and Prosthetics (CMS-6012-P)..........................................................
1210        Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities--      0938-AN65
            Update for FY 2006 (CMS-1282-F).......................................................
1211        State Children's Health Insurance Program (SCHIP); Redistribution of Unexpended SCHIP     0938-AN78
            Funds From the Appropriation for Fiscal Year (FY) 2002 (CMS-2230-FN)..................
1212        Extending Sunset Date for the Interim Final Regulation on Mental Health Parity (CMS-      0938-AN80
            4094-F3)..............................................................................
1213        Disproportionate Share Hospital Payments--Institutions for Mental Disease (IMDs) (CMS-    0938-AN88
            2062-N2)..............................................................................
1214        Hospice Wage Index for FY 2006 (CMS-1286-F)...........................................    0938-AN89
1215        Inpatient Rehabilitation Facility Classification Rule Compliance (CMS-1480-N).........    0938-AN92
1216        Withdrawal of Ambulance Fee Schedule Issued in Accordance With Federal District Court     0938-AN94
            Order in Lifestar Ambulance, Inc. v. U.S.--Medicare Covered Ambulance Services (CMS-
            1308-)................................................................................
1217        Immunization Standard for Long Term Care Facilities (CMS-3198-F)......................    0938-AN95
1218        Disproportionate Share Hospital Payments -- Institutions for Mental Disease (IMDs)        0938-AN96
            (CMS-2209-N)..........................................................................
1219        Medicare Prescription Drug Discount Card (CMS-4063-F).................................    0938-AN97
1220        Inpatient Hospital Deductible and Hospital and Extended Care Services Coinsurance         0938-AO00
            Amounts for Calendar Year 2006 (CMS-8026-N)...........................................
1221        Part A Premiums for Calendar Year 2006 for the Uninsured Aged and for Certain Disabled    0938-AO01
            Individuals Who Have Exhausted Other Entitlement (CMS-8025-N).........................
1222        Medicare Part B Monthly Actuarial Rates and Premium Rate Beginning January 1, 2006        0938-AO02
            (CMS-8027-N)..........................................................................
----------------------------------------------------------------------------------------------------------------
                          Administration for Children and Families--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
1223        Safeguarding Child Support and Expanded Federal Parent Locator Services (FPLS)            0970-AC01
            Information...........................................................................
[[Page 64563]]
1224        Developmental Disabilities and Bill of Rights Act.....................................    0970-AC07
1225        Administrative Cost Sharing Under TANF................................................    0970-AC15
1226        Care and Placement of Unaccompanied Alien Children....................................    0970-AC20
1227        Chafee National Youth in Transition Database..........................................    0970-AC21
1228        Medical Support.......................................................................    0970-AC22
1229        Adoption and Foster Care Analysis and Reporting System................................    0970-AC23
----------------------------------------------------------------------------------------------------------------
                           Administration for Children and Families--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
1230        Administrative Costs for Children in Title IV-E Foster Care...........................    0970-AC14
1231        Head Start Transportation.............................................................    0970-AC16
1232        Child Care and Development Fund State Match Provisions................................    0970-AC18
1233        Reasonable Quantitative Standard for Review and Adjustment of Child Support Orders....    0970-AC19
----------------------------------------------------------------------------------------------------------------
_______________________________________________________________________
Department of Health and Human Services (HHS)       Proposed Rule Stage
Office of the Secretary (OS)
_______________________________________________________________________
985. 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                            04/00/06
NPRM Comment Period End         06/00/06
Regulatory Flexibility Analysis Required: No
Small Entities Affected: No
Government Levels Affected: None
Agency Contact: Joel Jay Schaer, Regulations Officer, Department of
Health and Human Services, Office of the Secretary, Office of Inspector
General, 330 Independence Avenue SW., Washington, DC 20201
Phone: 202 619-0089
RIN: 0991-AB03
_______________________________________________________________________
986. MEDICARE AND STATE HEALTH CARE PROGRAMS: FRAUD AND ABUSE; SAFE
HARBOR FOR CERTAIN ELECTRONIC PRESCRIBING ARRANGEMENTS UNDER THE ANTI-
KICKBACK STATUTE
Priority: Other Significant
Legal Authority: PL 100-93, sec 14(a); PL 108-173, sec 101(a)(4)(D)(6)
CFR Citation: 42 CFR 1001
Legal Deadline: None
Abstract: This rule will establish a safe harbor with respect to the
provision of nonmonetary remuneration--in the form of hardware,
software, or information technology and training services--necessary
and used solely to receive and transmit electronic prescription
information in accordance with section 1860-D of the Social Security
Act.
Timetable:
________________________________________________________________________
Action                            Date                      FR Cite
________________________________________________________________________
NPRM                            10/11/05                    70 FR 59015
NPRM Comment Period End         12/12/05
Final Action                    03/00/06
Regulatory Flexibility Analysis Required: No
Government Levels Affected: None
Agency Contact: Joel Jay Schaer, Regulations Officer, Department of
Health and Human Services, Office of the Secretary, Office of Inspector
General, 330 Independence Avenue SW., Washington, DC 20201
Phone: 202 619-0089
RIN: 0991-AB39
[[Page 64564]]
_______________________________________________________________________
Department of Health and Human Services (HHS)          Final Rule Stage
Office of the Secretary (OS)
_______________________________________________________________________
987. 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                    03/00/06
Regulatory Flexibility Analysis Required: No
Government Levels Affected: None
Agency Contact: Joel Jay Schaer, Regulations Officer, Department of
Health and Human Services, Office of the Secretary, Office of Inspector
General, 330 Independence Avenue SW., Washington, DC 20201
Phone: 202 619-0089
Related RIN: Related to 0991-AB06
RIN: 0991-AA91
_______________________________________________________________________
988. 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                    03/00/06
Regulatory Flexibility Analysis Required: No
Small Entities Affected: No
Government Levels Affected: None
Agency Contact: Joel Jay Schaer, Regulations Officer, Department of
Health and Human Services, Office of the Secretary, Office of Inspector
General, 330 Independence Avenue SW., Washington, DC 20201
Phone: 202 619-0089
RIN: 0991-AB16
_______________________________________________________________________
989. CLARIFICATION OF TERMS AND APPLICATION OF PROGRAM EXCLUSION
AUTHORITY FOR SUBMITTING CLAIMS CONTAINING EXCESSIVE CHARGES
Priority: Substantive, Nonsignificant
Legal Authority: Social Security Act, sec 112B(6); Social Security Act,
sec 112B(6)(A)
CFR Citation: 42 CFR 1001
Legal Deadline: None
Abstract: This rule would amend the Office of Inspector General's
exclusion regulations at 42 CFR 1001.701, addressing excessive claims,
by including definitions for the terms ``substantially in excess'' and
``usual charges,'' and by clarifying the ``good cause'' exception set
forth in this section.
Timetable:
________________________________________________________________________
Action                            Date                      FR Cite
________________________________________________________________________
NPRM                            09/15/03                    68 FR 53939
NPRM Comment Period End         11/14/03
Final Action                    04/00/06
Regulatory Flexibility Analysis Required: No
Government Levels Affected: None
Agency Contact: Joel Jay Schaer, Regulations Officer, Department of
Health and Human Services, Office of the Secretary, Office of Inspector
General, 330 Independence Avenue SW., Washington, DC 20201
Phone: 202 619-0089
RIN: 0991-AB23
_______________________________________________________________________
990. HEALTH INSURANCE PORTABILITY AND ACCOUNTABILITY ACT--ENFORCEMENT
Priority: Other Significant
Legal Authority: Subtitle F of title II of PL 104-191; 42 USC 1320d-5
CFR Citation: 45 CFR 160, subparts C to E
Legal Deadline: None
Abstract: This rulemaking would seek to establish a framework for
enforcing compliance with the ``administrative simplification''
provisions of the Health Insurance Portability and Accountability Act
(HIPAA) of 1996--subtitle F of title II of Public Law 104-191, through
the imposition of civil money penalties under 42 U.S.C. 1320d-5.
Timetable:
________________________________________________________________________
Action                            Date                      FR Cite
________________________________________________________________________
NPRM                            04/18/05                    70 FR 20224
Final Action                    02/00/06
Regulatory Flexibility Analysis Required: No
Small Entities Affected: Businesses
Government Levels Affected: None
Agency Contact: Carol Conrad, Department of Health and Human Services,
Room 5347, Office of the General Counsel, 330 Independence Avenue SW.,
Washington, DC 20201
Phone: 202 690-1840
RIN: 0991-AB29
[[Page 64565]]
_______________________________________________________________________
991. MEDICARE AND STATE HEALTH CARE PROGRAMS: FRAUD AND ABUSE; SAFE
HARBOR FOR FEDERALLY QUALIFIED HEALTH CENTERS UNDER THE ANTI-KICKBACK
STATUTE
Priority: Other Significant
Legal Authority: PL 100-93, sec 14(a); PL 108-173, sec 431
CFR Citation: 42 CFR 1001
Legal Deadline: Final, Statutory, December 8, 2004.
Abstract: This rule will set forth standards for the new anti-kickback
safe harbor addressing remuneration between federally qualified health
centers and certain providers where significant community benefit
exits.
Timetable:
________________________________________________________________________
Action                            Date                      FR Cite
________________________________________________________________________
Interim Final Rule              07/01/05                    70 FR 38081
Interim Final Rule Comment
Period End                      08/01/05
Final Action                    02/00/06
Regulatory Flexibility Analysis Required: No
Small Entities Affected: No
Government Levels Affected: None
Agency Contact: Joel Jay Schaer, Regulations Officer, Department of
Health and Human Services, Office of the Secretary, Office of Inspector
General, 330 Independence Avenue SW., Washington, DC 20201
Phone: 202 619-0089
Related RIN: Related to 0991-AB06, Related to 0991-AA91
RIN: 0991-AB38
_______________________________________________________________________
Department of Health and Human Services (HHS)         Long-Term Actions
Office of the Secretary (OS)
_______________________________________________________________________
992. 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: Jeffrey S. Davis, Associate General Counsel, Department
of Health and Human Services, Office of the Secretary, Office of the
General Counsel, Room 5362, HHS Cohen Building, Room 4760, 330
Independence Avenue SW., Washington, DC 20201
Phone: 202 619-0150
RIN: 0991-AB18
_______________________________________________________________________
993. SALARY OFFSET
Priority: Substantive, Nonsignificant
Unfunded Mandates: Undetermined
Legal Authority: 5 USC 5514; 5 CFR 550
CFR Citation: 45 CFR 33
Legal Deadline: None
Abstract: The Department will add a new part 33 to title 45 of the Code
of Federal Regulations (CFR) to implement the salary offset provisions
of the Debt Collection Improvement Act of 1996 (DCIA), Public Law 104-
134, 110 Stat. 1321 to 1358, codified at 5 U.S.C. 5514, as implemented
by the Office of Personnel Management at 5 CFR part 550, subpart K. The
proposed rule is required in order to bring the Department's salary
offset provisions in compliance with Governmentwide regulations
published by the Office of Personnel Management.
Timetable:
________________________________________________________________________
Action                            Date                      FR Cite
________________________________________________________________________
NPRM                            07/13/04
Final Action                     To Be                       Determined
Regulatory Flexibility Analysis Required: No
Small Entities Affected: No
Government Levels Affected: None
Agency Contact: Jeffrey S. Davis, Associate General Counsel, Department
of Health and Human Services, Office of the Secretary, Office of the
General Counsel, HHS Cohen Building, Room 4760, 330 Independence Avenue
SW., Washington, DC 20201
Phone: 202 619-0150
RIN: 0991-AB19
_______________________________________________________________________
994. REVISIONS TO THE WAIVER PROVISIONS OF THE OFFICE OF INSPECTOR
GENERAL'S (OIG) EXCLUSION AUTHORITIES
Priority: Substantive, Nonsignificant
Legal Authority: PL 108-173, sec 949; PL 105-33, sec 4331; Social
Security Act, sec 1128(c)(3)(b)
CFR Citation: 42 CFR 1001
Legal Deadline: None
Abstract: In accordance with section 949 of the Medicare Prescription
Drug, Improvement, and Modernization Act of 2003, this rule would
revise the OIG's exclusion authority to permit any Federal health care
program to request a waiver of an OIG exclusion imposed under sections
1128(a)(1), 1128(a)(3), or 1128(a)(4) of the Social Security Act.
Timetable:
________________________________________________________________________
Action                            Date                      FR Cite
________________________________________________________________________
NPRM                             To Be                       Determined
Regulatory Flexibility Analysis Required: No
Small Entities Affected: No
Government Levels Affected: Federal
Agency Contact: Joel Jay Schaer, Regulations Officer, Department of
Health and Human Services, Office of
[[Page 64566]]
the Secretary, Office of Inspector General, 330 Independence Avenue
SW., Washington, DC 20201
Phone: 202 619-0089
RIN: 0991-AB33
_______________________________________________________________________
Department of Health and Human Services (HHS)         Completed Actions
Office of the Secretary (OS)
_______________________________________________________________________
995. 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
CFR Citation: 45 CFR 80; 45 CFR 84; 45 CFR 86; 45 CFR 90; 45 CFR 91
Completed:
________________________________________________________________________
Reason                            Date                      FR Cite
________________________________________________________________________
Final Rule                      05/09/05                    70 FR 24314
Regulatory Flexibility Analysis Required: No
Small Entities Affected: Businesses, Governmental Jurisdictions,
Organizations
Government Levels Affected: Federal, Local, State, Tribal
Agency Contact: Robinsue Frohboese
Phone: 202 619-0403
RIN: 0991-AB10
_______________________________________________________________________
Department of Health and Human Services (HHS)       Proposed Rule Stage
Substance Abuse and Mental Health Services Administration (SAMHSA)
_______________________________________________________________________
996. 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                            12/00/05
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)
_______________________________________________________________________
997. 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                    12/00/05
Regulatory Flexibility Analysis Required: No
Small Entities Affected: No
Government Levels Affected: Federal
Agency Contact: Joseph Denis Faha, Director, DLEA, SAMHSA, Department
of Health and Human Services, Substance Abuse and Mental Health
Services Administration, Room 12C-15, 5600 Fishers Lane, Rockville, MD
20857
Phone: 301 443-7017
Fax: 301 443-1450
Email: jfaha@samhsa.gov
RIN: 0930-AA12
[[Page 64567]]
_______________________________________________________________________
Department of Health and Human Services (HHS)       Proposed Rule Stage
Centers for Disease Control and Prevention (CDC)
_______________________________________________________________________
998. 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                            06/00/06
Regulatory Flexibility Analysis Required: Undetermined
Small Entities Affected:  Businesses
Government Levels Affected: None
Agency Contact: Jon Szalajada, Acting Chief, Policy and Standards
Branch, HHS, CDC, NIOSH, 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
_______________________________________________________________________
999. AMENDMENTS TO SELF-CONTAINED BREATHING APPARATUS REQUIREMENTS FOR
APPROVAL OF RESPIRATORY PROTECTIVE DEVICES
Priority: Other Significant
Legal Authority: 29 USC 651 et seq; 30 USC 3; 30 USC 5; 30 USC 7; 30
USC 811; 30 USC 842; 30 USC 844
CFR Citation: 42 CFR 84
Legal Deadline: None
Abstract: NIOSH plans to modify sections of 42 CFR part 84 concerning
performance testing and other specifications for the certification of
closed-circuit, self-contained breathing apparatus. These respiratory
protective devices are used in emergencies for the protection of miners
and workers in other industries.
Timetable:
________________________________________________________________________
Action                            Date                      FR Cite
________________________________________________________________________
NPRM                            06/00/06
Regulatory Flexibility Analysis Required: Undetermined
Small Entities Affected:  Businesses
Government Levels Affected: None
Agency Contact: Jon Szalajada, Acting Chief, Policy and Standards
Branch, HHS, CDC, NIOSH, Department of Health and Human Services,
Centers for Disease Control and Prevention, NIOSH, P.O. Box 18070, 626
Cochrans Mill Road, Pittsburgh, PA 15236
Phone: 412 386-4000
RIN: 0920-AA10
_______________________________________________________________________
1000. CONTROL OF COMMUNICABLE DISEASES, INTERSTATE AND FOREIGN
QUARANTINE
 Regulatory Plan: This entry is Seq. No. 42 in part II of this issue of
the Federal Register.
RIN: 0920-AA12
_______________________________________________________________________
Department of Health and Human Services (HHS)          Final Rule Stage
Centers for Disease Control and Prevention (CDC)
_______________________________________________________________________
1001. [bull] PROCEDURES FOR DESIGNATING CLASSES OF EMPLOYEES AS MEMBERS
OF THE SPECIAL EXPOSURE COHORT UNDER THE ENERGY EMPLOYEES OCCUPATIONAL
ILLNESS COMPENSATION PROGRAM ACT OF 2000; AMENDMENTS
Priority: Other Significant
Legal Authority: Not Yet Determined
CFR Citation: None
Legal Deadline: None
Abstract: HHS is amending its procedures to consider designating
classes of employees to be added to the Special Exposure Cohort under
the Energy Employees Occupational Illness Compensation Program Act of
2000 (``EEOICPA''), 42 U.S.C. sections 7384-7385. HHS must change these
procedures to implement amendments to EEOICPA enacted on October
28, 2004, as part of the Ronald W. Reagan National Defense
Authorization Act for Fiscal Year 2005, Pub. L. No. 108-375 (codified
as amended in scattered sections of 42 U.S.C.).
Timetable:
________________________________________________________________________
Action                            Date                      FR Cite
________________________________________________________________________
Interim Final Rule              12/00/05
Regulatory Flexibility Analysis Required: No
Small Entities Affected: No
Government Levels Affected: None
Agency Contact: Larry Elliott, Director, Office of Compensation
Analysis and Support, Department of Health and Human Services, Centers
for Disease Control and Prevention, NIOSH, R44, 4676 Columbia Pkwy, MS
C-46, Cincinnati, OH 45226
Phone: 513 533-6825
RIN: 0920-AA13
[[Page 64568]]
_______________________________________________________________________
Department of Health and Human Services (HHS)             Prerule Stage
Food and Drug Administration (FDA)
_______________________________________________________________________
1002. [bull] MEDICAL DEVICES; CURRENT GOOD MANUFACTURING PRACTICE (CGMP)
FINAL RULE; QUALITY SYSTEMS REGULATIONS (SECTION 610 REVIEW)
Priority: Routine and Frequent
Legal Authority: 5 USC 610
CFR Citation: 21 CFR 808; 21 CFR 812; 21 CFR 820
Legal Deadline: None
Abstract: FDA is initiating a review under section 610 of the
Regulatory Flexibility Act for the regulations in part 820. The purpose
of this review is to determine if any of the regulations in part 820
should be continued without change, or should be amended or rescinded,
to minimize adverse economic impacts on small entities. FDA will
consider and solicit comments on the following; 1) The continued need
for a regulation in part 820; 2) the nature of complaints or comments
received concerning a regulation in part 820; 3) the complexity of a
regulation in part 820; 4) the extent to which a regulation in part 820
overlaps, duplicates, or conflicts with other Federal, State, or
government rules; and 5) the degree to which technology economic
conditions or other factors have changed in the area affected by a
regulation in part 820.
Timetable:
________________________________________________________________________
Action                            Date                      FR Cite
________________________________________________________________________
Begin Review of Current
Regulation                      11/00/05
Regulatory Flexibility Analysis Required: No
Government Levels Affected: Undetermined
Federalism:  Undetermined
Agency Contact: Myrna Hanna, Regulations Staff, Department of Health
and Human Services, Food and Drug Administration, Center for Devices
and Radiological Health, HFZ-215, 1350 Piccard Drive, Rockville, MD
20850
Phone: 301 827-2971
Fax: 301 594-4765
Email: myh@fda.hhs.gov
RIN: 0910-AF71
_______________________________________________________________________
Department of Health and Human Services (HHS)       Proposed Rule Stage
Food and Drug Administration (FDA)
_______________________________________________________________________
1003. FOREIGN AND DOMESTIC ESTABLISHMENT REGISTRATION AND LISTING
REQUIREMENTS FOR HUMAN DRUGS, INCLUDING DRUGS THAT ARE REGULATED UNDER A
BIOLOGICS LICENSE APPLICATION, AND ANIMAL DRUGS
 Regulatory Plan: This entry is Seq. No. 43 in part II of this issue of
the Federal Register.
RIN: 0910-AA49
_______________________________________________________________________
1004. CHRONIC WASTING DISEASE: CONTROL OF FOOD PRODUCTS AND COSMETICS
DERIVED FROM EXPOSED ANIMAL POPULATIONS
Priority: Other Significant
Legal Authority: 42 USC 264; 21 USC 301 et seq
CFR Citation: Not Yet Determined
Legal Deadline: None
Abstract: The Food and Drug Administration (FDA) is proposing to
prohibit the use of cervids (deer, elk) for food, including dietary
supplements, and cosmetics if the cervids have been exposed to chronic
wasting disease (CWD). FDA is proposing this regulation because of
potential risks to health.
CWD is a type of transmissible spongiform encephalopathy (TSE), a group
of fatal, neurodegenerative diseases that include bovine spongiform
encephalopathy (BSE) in cattle, scrapie in sheep and goats, and
Creutzfeldt-Jakob disease (CJD) in humans. The disease has been
identified in wild and farmed elk and wild deer populations.
CWD has been found in cervid populations in certain areas of Wisconsin,
Colorado, Nebraska, Wyoming, Kansas, Montana, Oklahoma, South Dakota,
New Mexico, Minnesota, and Canada. In 1999, the World Health
Organization said there is no evidence that CWD transmits to humans.
However, it also suggested any part of a deer or elk believed to be
diseased should not be eaten. Results of some studies using in vitro
techniques have suggested that transmission to humans could possibly
occur. However, if it does occur, it is likely to be through a very
inefficient process.
Currently, there are no validated analytical tests to identify animals
in the preclinical phase of CWD, or any other TSE. In addition, no test
exists to ensure food safety. CWD typically exhibits a long incubation
period, during which time animals appear normal but are potentially
infectious. Therefore, DA is proposing to require that food or cosmetic
products derived from animals exposed to CWD not enter into commerce.
Timetable:
________________________________________________________________________
Action                            Date                      FR Cite
________________________________________________________________________
NPRM                            05/00/06
Regulatory Flexibility Analysis Required: Yes
Small Entities Affected: Businesses
Government Levels Affected: Undetermined
Federalism:  Undetermined
Agency Contact: Rebecca Buckner, Consumer Safety Officer, Department of
Health and Human Services, Food and Drug Administration, HFS-306,
Center for Food Safety and Applied Nutrition, 5100 Paint Branch
Parkway, HFS-366, College Park, MD 20740
Phone: 301 436-1486
Fax: 301 436-2632
Email: rebecca.buckner@cfsan.fda.gov
RIN: 0910-AC21
_______________________________________________________________________
1005. 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; 21 USC 360i; 21
USC 371
CFR Citation: 21 CFR 868.2700
Legal Deadline: None
Abstract: The Food and Drug Administration (FDA) is proposing to
reclassify pressure regulators for use with medical oxygen from class I
to class II and to establish a special
[[Page 64569]]
control for oxygen pressure regulators to address problems of fire and
explosion associated with use of these devices. The special control
will be a guidance document that includes standardized testing,
performance, and labeling guidance for industry. Devices that meet the
special control will be exempt from the premarket notification
requirements of the Act. The agency believes it is taking a least
burdensome approach for industry. This proposed rule will phase-in a
compliance approach that will minimize the cost. FDA seeks to
reclassify these devices under section 513(e)(1) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 360c(e)(1)).
Timetable:
________________________________________________________________________
Action                            Date                      FR Cite
________________________________________________________________________
NPRM                            12/00/05
Regulatory Flexibility Analysis Required: Undetermined
Government Levels Affected: Undetermined
Federalism:  Undetermined
Agency Contact: Myrna Hanna, Regulations Staff, Department of Health
and Human Services, Food and Drug Administration, Center for Devices
and Radiological Health, HFZ-215, 1350 Piccard Drive, Rockville, MD
20850
Phone: 301 827-2971
Fax: 301 594-4765
Email: myh@fda.hhs.gov
RIN: 0910-AC30
_______________________________________________________________________
1006. SUBMISSION OF STANDARDIZED ELECTRONIC STUDY DATA FROM CLINICAL
STUDIES EVALUATING HUMAN DRUGS AND BIOLOGICS
 Regulatory Plan: This entry is Seq. No. 44 in part II of this issue of
the Federal Register.
RIN: 0910-AC52
_______________________________________________________________________
1007. 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                            04/00/06
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
_______________________________________________________________________
1008. POSITRON EMISSION TOMOGRAPHY DRUGS; CURRENT GOOD MANUFACTURING
PRACTICES
Priority: Other Significant
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                            09/20/05                    70 FR 55038
NPRM Comment Period End         12/19/05
Final Action                    12/00/06
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
_______________________________________________________________________
1009. 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
[[Page 64570]]
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                            06/00/06
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, 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
_______________________________________________________________________
1010. CONTENT AND FORMAT OF LABELING FOR HUMAN PRESCRIPTION DRUGS AND
BIOLOGICS; REQUIREMENTS FOR PREGNANCY AND LACTATION LABELING
 Regulatory Plan: This entry is Seq. No. 45 in part II of this issue of
the Federal Register.
RIN: 0910-AF11
_______________________________________________________________________
1011. 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)
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                            01/00/06
Regulatory Flexibility Analysis Required: Yes
Small Entities Affected: Businesses
Government Levels Affected: None
Agency Contact: Mical E. Honigfort, Consumer Safety Officer, Department
of Health and Human Services, Food and Drug Administration, HFS-265,
5100 Paint Branch Parkway, College Park, MD 20740
Phone: 301 436-1278
Fax: 301-436-2972
Email: mhonigfo@cfsan.fda.gov
RIN: 0910-AF12
_______________________________________________________________________
1012. CHARGING FOR INVESTIGATIONAL DRUGS
Priority: Substantive, Nonsignificant. Major status under 5 USC 801 is
undetermined.
Legal Authority: 21 USC 321; 21 USC 331; 21 USC 351 to 353; 21 USC 355;
21 USC 371; 42 USC 262
CFR Citation: 21 CFR 312.7; 21 CFR 312.8
Legal Deadline: None
Abstract: The proposed rule would amend FDA's investigational new drug
regulation concerning charging for investigational drugs. The proposed
rule would clarify the circumstances in which charging for an
investigational drug in a clinical trial is appropriate, set forth
criteria for charging for an investigational drug for the different
types of treatment uses to be described in the agency's proposed rule
on treatment use of investigational drugs, and clarify what costs can
be recovered for an investigational drug. The proposed rule is intended
to permit charging for a broader range of investigational uses than is
explicitly permitted in current regulations.
Timetable:
________________________________________________________________________
Action                            Date                      FR Cite
________________________________________________________________________
NPRM                            05/00/06
Regulatory Flexibility Analysis Required: Undetermined
Small Entities Affected:  Businesses
Government Levels Affected: None
Agency Contact: Christine F. Rogers, Regulatory Counsel, Department of
Health and Human Services, Food and Drug Administration, Suite 3059
(HFD-7), Center for Drug Evaulation and Research, 5515 Security Lane,
Rockville, MD 20852
Phone: 301 594-2041
Fax: 301-827-5562
Email: rogersc@cder.fda.gov
RIN: 0910-AF13
_______________________________________________________________________
1013. EXPANDED ACCESS TO INVESTIGATIONAL DRUGS FOR TREATMENT USE
 Regulatory Plan: This entry is Seq. No. 46 in part II of this issue of
the Federal Register.
RIN: 0910-AF14
_______________________________________________________________________
1014. 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 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 related to its activities as a blood establishment to also
distribute blood derivatives.
Timetable:
________________________________________________________________________
Action                            Date                      FR Cite
________________________________________________________________________
NPRM                            12/00/05
Regulatory Flexibility Analysis Required: No
Government Levels Affected: None
[[Page 64571]]
Additional Information: Delayed effective date of portion of rule to
12/01/06, effective date of non-stayed portion of final rule, 64 FR
67720, December 3, 1999
Agency Contact: Kathleen E. Swisher, Supervisory Regulatory Counsel,
Department of Health and Human Services, Food and Drug Administration,
Center for Biologics Evaluation and Research, 1401 Rockville Pike,
Suite 200N, (HFM-17), Rockville, MD 20852
Phone: 301 827-6210
Fax: 301 827-9434
RIN: 0910-AF16
_______________________________________________________________________
1015. 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 products had been licensed by the National
Institutes of Health prior to 1972, when regulatory authority over
these products was transferred to FDA. The regulation prohibits the use
of Group A streptococcus organisms and derivatives of Group A
streptococcus as ingredients in Bacterial Vaccines and Bacterial
Antigens with ``No U.S. Standard of Potency.'' The regulation was
written to apply to a group of products that are no longer on the
market, namely, streptococcus vaccines and antigens with ``No U.S.
Standard of Potency'' that were not purified. The regulation was never
intended to refer to purified streptococcus vaccines, which were not
developed at that time. Therefore, the regulation is being revoked.
Timetable:
________________________________________________________________________
Action                            Date                      FR Cite
________________________________________________________________________
NPRM - Companion to Direct Final
Rule                            10/00/05
Direct Final Rule               10/00/05
Regulatory Flexibility Analysis Required: No
Small Entities Affected: No
Government Levels Affected: None
Agency Contact: Valerie Butler, Consumer Safety Officer, Department of
Health and Human Services, Food and Drug Administration, Suite 200N
(HFM-17), Center for Biologics Evaluation and Research, 1401 Rockville
Pike, Suite 200N, Rockville, MD 20852
Phone: 301 827-6210
Fax: 301 827-9434
RIN: 0910-AF20
_______________________________________________________________________
1016. OBSTETRICAL AND GYNECOLOGICAL DEVICES; DESIGNATION OF SPECIAL
CONTROL FOR CONDOMS AND CONDOMS WITH SPERMICIDAL LUBRICANT
Priority: Other Significant. Major status under 5 USC 801 is
undetermined.
Legal Authority: 21 USC 360c
CFR Citation: 21 CFR 884.5300; 21 CFR 884.5310
Legal Deadline: None
Abstract: The classification regulations for male condoms would be
amended to specify a labeling guidance document as a special control
for condoms made from natural rubber latex. The new special control
guidance document would identify issues presented by these devices, and
would provide detailed recommendations for labeling to address these
issues. FDA believes that compliance with the recommendations in the
guidance, or with some equivalent means of addressing the identified
issues together with the general controls, will provide a reasonable
assurance of the safety and effectiveness of these devices. These
labeling recommendations are also consistent with the labeling
requirements of 21 CFR 801. The rule will demonstrate how the agency is
moving forward to meet the congressional directive of Public Law 106-
554 that FDA review condom labeling to assure that the information
regarding the overall effectiveness or lack of effectiveness of condoms
in preventing sexually transmitted diseases is medically accurate.
Timetable:
________________________________________________________________________
Action                            Date                      FR Cite
________________________________________________________________________
NPRM                            12/00/05
Regulatory Flexibility Analysis Required: Undetermined
Small Entities Affected:  Businesses
Government Levels Affected: None
Federalism:  Undetermined
Agency Contact: Myrna Hanna, Regulations Staff, Department of Health
and Human Services, Food and Drug Administration, Center for Devices
and Radiological Health, HFZ-215, 1350 Piccard Drive, Rockville, MD
20850
Phone: 301 827-2971
Fax: 301 594-4765
Email: myh@fda.hhs.gov
RIN: 0910-AF21
_______________________________________________________________________
1017. 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; 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 606; 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, particularly those related to blood donor
eligibility, 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, and 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                            06/00/06
Regulatory Flexibility Analysis Required: No
Small Entities Affected: Businesses
[[Page 64572]]
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
Email: mckeever@cber.fda.gov
Related RIN: Split from 0910-AB26
RIN: 0910-AF25
_______________________________________________________________________
1018. OVER-THE-COUNTER (OTC) DRUG REVIEW--INTERNAL ANALGESIC PRODUCTS
Priority: Routine and Frequent
Legal Authority: 21 USC 321p; 21 USC 351 to 353; 21 USC 355; 21 USC
360a; 21USC 371a; 21 USC 331; 21 USC 360; 21 USC 360gg to 360ss; 21 USC
371; 21 USC 374; 21 USC 379e; 42 USC 216; 42 USC 241; 42 USC 262; 42
USC 264
CFR Citation: 21 CFR 201; 21 CFR 310; 21 CFR 330 to 358
Legal Deadline: None
Abstract: The OTC drug review establishes conditions under which OTC
drugs are considered generally recognized as safe and effective and not
misbranded. After a final monograph (i.e. final rule) is issued, only
OTC drugs meeting the conditions of the monograph, or having an
approved new drug application, may be legally marketed. One action
addresses labeling intended to better inform consumers of potential
risks associated with these products. The second action addresses
products marketed for children under two years old and weight- and age-
based dosing for children's products. The third action addresses
combination products containing the analgesic acetaminophen or aspirin
and sodium bicarbonate used as an antacid ingredient. The fourth action
addresses products labeled to relieve upset stomach associated with
overindulgence in food and drink and to relieve symptoms associated
with a hangover.
Timetable:
________________________________________________________________________
Action                            Date                      FR Cite
________________________________________________________________________
NPRM (Amendment) (Required
Warnings and Other Labeling)    01/00/06
NPRM (Amendment) (Pediatric)    03/00/06
NPRM (Amendment) (Combinations
with Sodium Bicarbonate)        10/00/06
NPRM (Amendment)
(Overindulgence/ Hangover)      01/00/06
NPRM (Amendment) (Steven's
Johnson Warnings)               03/00/06
NPRM (Amendment) (Cardiovascular
Warnings)                       03/00/06
Final Action (Internal
Analgesics)                     10/00/06
Regulatory Flexibility Analysis Required: Yes
Small Entities Affected: Businesses
Government Levels Affected: None
Agency Contact: Gerald M. Rachanow, Regulatory Counsel, Division of
Over-the-Counter Drug Products, Department of Health and Human
Services, Food and Drug Administration, 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
_______________________________________________________________________
1019. OVER-THE-COUNTER (OTC) DRUG REVIEW--LABELING OF DRUG PRODUCTS FOR
OTC HUMAN USE
Priority: Routine and Frequent
Legal Authority: 21 USC 321p; 21 USC 351 to 353; 21 USC 355; 21 USC
360a; 21USC 371a; 21 USC 331; 21 USC 360; 21 USC 371; 21 USC 358; 21
USC 360gg to 360ss; 21 USC 374; 21 USC 379e; 42 USC 216; 42 USC 241; 42
USC 262; 42 USC 264
CFR Citation: 21 CFR 201; 21 CFR 310; 21 CFR 330 to 358
Legal Deadline: None
Abstract: The OTC drug review establishes conditions under which OTC
drugs are considered generally recognized as safe and effective and not
misbranded. After a final monograph (i.e. final rule) is issued, only
OTC drugs meeting the conditions of the monograph, or having an
approved new drug application, may be legally marketed. This action
addresses labeling for convenience (small) size OTC drug packages.
Timetable:
________________________________________________________________________
Action                            Date                      FR Cite
________________________________________________________________________
NPRM (Convenience Sizes)        12/00/05
Regulatory Flexibility Analysis Required: Yes
Small Entities Affected: Businesses
Government Levels Affected: None
Agency Contact: Gerald M. Rachanow, Regulatory Counsel, Division of
Over-the-Counter Drug Products, Department of Health and Human
Services, Food and Drug Administration, 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
_______________________________________________________________________
1020. OVER-THE-COUNTER (OTC) DRUG REVIEW--OPHTHALMIC PRODUCTS
Priority: Routine and Frequent
Legal Authority: 21 USC 321p; 21 USC 351 to 353; 21 USC 355; 21 USC
360a; 21 USC 371a; 21 USC 331; 21 USC 360; 21 USC 371
CFR Citation: 21 CFR 201; 21 CFR 310; 21 CFR 330 to 358
Legal Deadline: None
Abstract: The OTC drug review establishes conditions under which OTC
drugs are considered generally recognized as safe and effective and not
misbranded. After a final monograph (i.e. final rule) is issued, only
OTC drugs meeting the conditions of the monograph, or having an
approved new drug application, may be legally marketed. This action
addresses emergency first aid eyewash products.
Timetable:
________________________________________________________________________
Action                            Date                      FR Cite
________________________________________________________________________
NPRM (Amendment) (Emergency
First Aid Eyewashes)            03/00/06
Regulatory Flexibility Analysis Required: Yes
Small Entities Affected: Businesses
Government Levels Affected: None
[[Page 64573]]
Agency Contact: Gerald M. Rachanow, Regulatory Counsel, Division of
Over-the-Counter Drug Products, Department of Health and Human
Services, Food and Drug Administration, 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
_______________________________________________________________________
1021. OVER-THE-COUNTER (OTC) DRUG REVIEW--SUNSCREEN PRODUCTS
Priority: Routine and Frequent
Legal Authority: 21 USC 321p; 21 USC 351 to 353; 21 USC 355; 21 USC
360a; 21 USC 371a; 21 USC 331; 21 USC 360; 21 USC 371
CFR Citation: 21 CFR 201; 21 CFR 310; 21 CFR 330 to 358
Legal Deadline: None
Abstract: The OTC drug review establishes conditions under which OTC
drugs are considered generally recognized as safe and effective and not
misbranded. After a final monograph (i.e. final rule) is issued, only
OTC drugs meeting the conditions of the monograph, or having an
approved new drug application, may be legally marketed. One action
addresses formulation, labeling, and testing requirements for both
ultraviolet B (UVB) and ultraviolet A (UVA) radiation protection, and
the other action addresses combination products containing sunscreen
and insect repellent ingredients.
Timetable:
________________________________________________________________________
Action                            Date                      FR Cite
________________________________________________________________________
ANPRM (Sunscreen and Insect
Repellent)                      10/00/06
NPRM (UVA/UVB)                  12/00/05
Regulatory Flexibility Analysis Required: Yes
Small Entities Affected: Businesses
Government Levels Affected: None
Agency Contact: Gerald M. Rachanow, Regulatory Counsel, Division of
Over-the-Counter Drug Products, Department of Health and Human
Services, Food and Drug Administration, 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
_______________________________________________________________________
1022. 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)     12/00/05
NPRM (Benzocaine)               12/00/05
Final Action (Phenyl
propanolamine)                  10/00/06
Regulatory Flexibility Analysis Required: Yes
Small Entities Affected: Businesses
Government Levels Affected: None
Agency Contact: Gerald M. Rachanow, Regulatory Counsel, Division of
Over-the-Counter Drug Products, Department of Health and Human
Services, Food and Drug Administration, 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
_______________________________________________________________________
1023. SUBSTANCES PROHIBITED FROM USE IN ANIMAL FOOD OR FEED
Priority: Other Significant
Legal Authority: 21 USC 321; 21 USC 342; 21 USC 343; 21 USC 349; 21 USC
371
CFR Citation: 21 CFR 589.2001
Legal Deadline: None
Abstract: The Food and Drug Administration (FDA) is proposing to amend
its regulations to prohibit the use of certain cattle origin materials
in the food or feed of all animals to help strengthen existing
safeguards to prevent the spread of bovine spongiform encephalopathy
(BSE) in U.S. cattle. The discovery of a BSE-positive dairy cow in
December 2003 has caused FDA to review its policies for prevention of
BSE which resulted in this rulemaking.
Timetable:
________________________________________________________________________
Action                            Date                      FR Cite
________________________________________________________________________
ANPRM                           07/14/04                    69 FR 42288
ANPRM Comment Period End        08/13/04
NPRM                            10/06/05                    70 FR 58569
NPRM Comment Period End         12/20/05
Final Action                    07/00/06
Regulatory Flexibility Analysis Required: Yes
Small Entities Affected: Businesses
Government Levels Affected: None
Agency Contact: Burt Pritchett, Biologist, Department of Health and
Human Services, Food and Drug Administration, Center for Veterinary
Medicine, HFV-222, 7519 Standish Place, MPN-4, Rockville, MD 20855
Phone: 240 453-6860
Fax: 240 453-6882
Email: burt.pritchett@fda.hhs.gov
RIN: 0910-AF46
_______________________________________________________________________
1024. 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
[[Page 64574]]
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)                12/00/05
Regulatory Flexibility Analysis Required: Yes
Small Entities Affected: Businesses
Government Levels Affected: None
Agency Contact: Gerald M. Rachanow, Regulatory Counsel, Division of
Over-the-Counter Drug Products, Department of Health and Human
Services, Food and Drug Administration, 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
_______________________________________________________________________
1025. OVER-THE-COUNTER (OTC) DRUG REVIEW--SKIN BLEACHING 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 drug products containing hydroquinone.
Timetable:
________________________________________________________________________
Action                            Date                      FR Cite
________________________________________________________________________
NPRM                            03/00/06
Regulatory Flexibility Analysis Required: Yes
Small Entities Affected: Businesses
Government Levels Affected: None
Agency Contact: Gerald M. Rachanow, Regulatory Counsel, Division of
Over-the-Counter Drug Products, Department of Health and Human
Services, Food and Drug Administration, 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
_______________________________________________________________________
1026. OVER-THE-COUNTER (OTC) DRUG REVIEW--STIMULANT DRUG PRODUCTS
Priority: Routine and Frequent
Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC
355; 21 USC 360; 21 USC 360a; 21 USC 371; 21 USC 371a
CFR Citation: 21 CFR 201; 21 CFR 310; 21 CFR 330 to 358
Legal Deadline: None
Abstract: The OTC drug review establishes conditions under which OTC
drugs are considered generally recognized as safe and effective and not
misbranded. After a final monograph (i.e. final rule) is issued, only
OTC drugs meeting the conditions of the monograph, or having an
approved new drug application, may be legally marketed. This action
addresses the use of stimulant active ingredients to relieve symptoms
associated with a hangover.
Timetable:
________________________________________________________________________
Action                            Date                      FR Cite
________________________________________________________________________
NPRM (Amendment) (Hangover)     01/00/06
Regulatory Flexibility Analysis Required: Yes
Small Entities Affected: Businesses
Government Levels Affected: None
Agency Contact: Gerald M. Rachanow, Regulatory Counsel, Division of
Over-the-Counter Drug Products, Department of Health and Human
Services, Food and Drug Administration, 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-AF56
_______________________________________________________________________
1027. DESIGNATION OF NEW ANIMAL DRUGS FOR MINOR USE AND MINOR SPECIES
Priority: Other Significant
Legal Authority: 21 USC 360ccc-2
CFR Citation: 21 CFR 514.1(d)(1)(i)
Legal Deadline: NPRM, Statutory, August 2, 2005.
Final, Statutory, August 2, 2006.
Abstract: This proposed rule is being issued in response to the Minor
Use and Minor Species (MUMS) Animal Health Act of 2004. The proposed
rule implements section 573 of the MUMS Act which sets forth the
functional requirements for drug sponsors requesting MUMS designation
for proposed new animal drugs. MUMS designation of a new animal drug
will allow drug sponsors to be granted seven years of exclusive
marketing rights for these limited demand new animal drugs once the
drugs are approved or conditionally approved. This regulation will
define content and format requirements for designation, requests
changing designation ownership, and annual reporting requirements. This
rule will also describe the criteria CVM will use for granting or
denying these requests. Specific sections of the rule will be dedicated
to documentation of MUMS status in a request, granting MUMS
designation, and revocation of MUMS designation. This is a voluntary
program for animal drug sponsors. While we do not have estimates of the
impact on the animal drug industry, we expect that this rule will have
a net beneficial impact on the industry with those firms participating
who hope to profit as a result of the market exclusivity provided by
the MUMS Act. A large number of these drug companies are classified as
small businesses.
Timetable:
________________________________________________________________________
Action                            Date                      FR Cite
________________________________________________________________________
NPRM                            09/27/05                    70 FR 56394
[[Page 64575]]
NPRM Comment Period End         12/12/05
Final Rule                      02/00/06
Regulatory Flexibility Analysis Required: No
Small Entities Affected: Businesses
Government Levels Affected: None
Agency Contact: Andrew J. Beaulieu, Director, Office of Minor Use and
Minor Species Animal Drug Development, Department of Health and Human
Services, Food and Drug Administration, Center for Veterinary Medicine,
7519 Standish Place, Room 180, HFV-50, MPN-4, Rockville, MD 20855
Phone: 240 276-9090
Fax: 240-276-9001
Email: abeaulie@cvm.fda.gov
RIN: 0910-AF60
_______________________________________________________________________
1028. [bull] BLOOD VESSELS RECOVERED WITH ORGANS AND INTENDED FOR USE IN
ORGAN TRANSPLANTATION
Priority: Substantive, Nonsignificant
Legal Authority: 42 USC 216; 42 USC 243; 42 USC 263a; 42 USC 264; 42
USC 271; 42 USC 273 to 274d; 42 USC 1302; 42 USC 1306
CFR Citation: 21 CFR 1271; 42 CFR 121
Legal Deadline: None
Abstract: FDA and Health Resources and Services Administration (HRSA)
are issuing a direct final rule and companion proposed rule to amend
the regulations to consider as part of an organ (and regulated by HRSA)
those blood vessels recovered with vascularized human organs that are
intended for use in organ transplantation; and to exclude such blood
vessels from the definition of human cells, tissues, and cellular and
tissue-based products (regulated by FDA). We are taking this action to
provide that blood vessels recovered with organs and intended for use
in organ transplantation will be governed by the regulations pertaining
to organs. We believe this change will eliminate unnecessary burden
resulting from an organ procurement organization's efforts to comply
with both FDA and HRSA requirements with respect to vascular tissue
(FDA jurisdiction) and organs (HRSA jurisdiction).
Timetable:
________________________________________________________________________
Action                            Date                      FR Cite
________________________________________________________________________
NPRM - Companion to Direct Final
Rule                            12/00/05
Direct Final Rule               12/00/05
Regulatory Flexibility Analysis Required: No
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
Email: mckeever@cber.fda.gov
RIN: 0910-AF65
_______________________________________________________________________
1029. [bull] INDEX OF LEGALLY MARKETED UNAPPROVED NEW ANIMAL DRUGS FOR
MINOR SPECIES
Priority: Other Significant
Legal Authority: 21 USC 360 ccc-1
CFR Citation: 21 CFR 516
Legal Deadline: NPRM, Statutory, February 2, 2006.
Final, Statutory, August 2, 2007.
Abstract: This proposed rule is being issued in response to the Minor
Use and Minor Species (MUMS) Animal Health Act of 2004. The proposed
rule implements section 572 of the MUMS Act which provides for a public
index listing of legally-marketed unapproved new animal drugs for minor
species of animals (species other than cattle, horses, swine, chickens,
turkeys, dogs, and cats). The drugs in this index will only be
indicated for use in non-food minor species or for use in early non-
food life stages to food-producing minor species. This proposed rule,
will, among other things, specify the procedures for requesting
eligibility for indexing and for requesting addition to the index as
well as the reporting requirements for index holders. This rule will
also describe the criteria requestors will use for assembling a
qualified expert panel to evaluate for FDA the safety and effectiveness
of a new animal drug proposed for indexing.
Timetable:
________________________________________________________________________
Action                            Date                      FR Cite
________________________________________________________________________
NPRM                            02/00/06
NPRM Comment Period End         05/00/06
Regulatory Flexibility Analysis Required: No
Small Entities Affected: Businesses
Government Levels Affected: None
Agency Contact: Andrew J. Beaulieu, Director, Office of Minor Use and
Minor Species Animal Drug Development, Department of Health and Human
Services, Food and Drug Administration, Center for Veterinary Medicine,
7519 Standish Place, Room 180, HFV-50, MPN-4, Rockville, MD 20855
Phone: 240 276-9090
Fax: 240-276-9001
Email: abeaulie@cvm.fda.gov
RIN: 0910-AF67
_______________________________________________________________________
1030. [bull] OVER-THE-COUNTER (OTC) DRUG REVIEW--POISON TREATMENT DRUG
PRODUCTS
Priority: Routine and Frequent. Major status under 5 USC 801 is
undetermined.
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 the ingredient ipecac.
Timetable:
________________________________________________________________________
Action                            Date                      FR Cite
________________________________________________________________________
NPRM (IPECAC)                   06/00/06
Regulatory Flexibility Analysis Required: Yes
Small Entities Affected: Businesses
Government Levels Affected: None
Agency Contact: Walter Ellenberg, Regulatory Health Project Manager,
Center for Drug Evaluation and Research, Department of Health and Human
Services, Food and Drug
[[Page 64576]]
Administration, CRP2 RMS214, HFD-560, Rockville, MD 20850
Phone: 301 827-2279
Fax: 301-827-2316
Email: walter.ellenberg@fda.hhs.gov
RIN: 0910-AF68
_______________________________________________________________________
1031. [bull] OVER-THE-COUNTER (OTC) DRUG REVIEW--TOPICAL ANTIMICROBIAL
DRUG 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. These actions
address the consumer healthcare, food handlers and healthcare
antiseptic products.
Timetable:
________________________________________________________________________
Action                            Date                      FR Cite
________________________________________________________________________
NPRM (Consumer Products)        03/00/06
NPRM (Food Handlers)            03/00/06
NPRM (Healthcare Antiseptics)   03/00/06
Regulatory Flexibility Analysis Required: Yes
Small Entities Affected: Businesses
Government Levels Affected: None
Agency Contact: Walter Ellenberg, Regulatory Health Project Manager,
Center for Drug Evaluation and Research, Department of Health and Human
Services, Food and Drug Administration, CRP2 RMS214, HFD-560,
Rockville, MD 20850
Phone: 301 827-2279
Fax: 301-827-2316
Email: walter.ellenberg@fda.hhs.gov
RIN: 0910-AF69
_______________________________________________________________________
Department of Health and Human Services (HHS)          Final Rule Stage
Food and Drug Administration (FDA)
_______________________________________________________________________
1032. 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 and streamline another mechanism for exporting
investigational new drugs while providing safeguards.
Timetable:
________________________________________________________________________
Action                            Date                      FR Cite
________________________________________________________________________
NPRM                            06/19/02                    67 FR 41642
Final Action                    02/00/06
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, Room 14C-17,
Rockville, MD 20857
Phone: 301 827-0587
Fax: 301 827-4774
Email: philip.chao@fda.hhs.gov
RIN: 0910-AA61
_______________________________________________________________________
1033. 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
_______________________________________________________________________
1034. SAFETY REPORTING REQUIREMENTS FOR HUMAN DRUG AND BIOLOGICAL
PRODUCTS
Priority: Other Significant. Major status under 5 USC 801 is
undetermined.
Unfunded Mandates: Undetermined
Legal Authority: 42 USC 216; 42 USC 241; 42 USC 242a; 42 USC 262; 42
USC 263; 42 USC 263a to 263-n; 42 USC 264; 42 USC 300aa; 21 USC 321; 21
USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 360; 21 USC 360b to
360j; 21 USC 361a; 21 USC 371; 21 USC 374; 21 USC 375; 21 USC 379e; 21
USC 381
[[Page 64577]]
CFR Citation: 21 CFR 310; 21 CFR 312; 21 CFR 314; 21 CFR 320; 21 CFR
600; 21 CFR 601; 21 CFR 606
Legal Deadline: None
Abstract: This regulation is one component of the Secretary's
initiative to reduce medical errors. The final rule would amend the
expedited and periodic safety reporting regulations for human drugs and
biological products to revise certain definitions and reporting formats
as recommended by the International Conference on Harmonisation and to
define new terms; to add to or revise current reporting requirements;
to revise certain reporting time frames; and propose other revisions to
these regulations to enhance the quality of safety reports received by
FDA.
Timetable:
________________________________________________________________________
Action                            Date                      FR Cite
________________________________________________________________________
NPRM                            03/14/03                    68 FR 12406
NPRM Comment Period Extended    06/18/03
NPRM Comment Period End         07/14/03
NPRM Comment Period Extension
End                             10/14/03
Comment Review End              06/00/06
Regulatory Flexibility Analysis Required: Yes
Small Entities Affected: Businesses
Government Levels Affected: Undetermined
Agency Contact: Carol Drew, Regulatory Counsel, Department of Health
and Human Services, Food and Drug Administration, Center for Drug
Evaluation and Research, 5515 Security Lane, Suite 1101 (HFD-7),
Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562
RIN: 0910-AA97
_______________________________________________________________________
1035. APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG; COMPLETE
RESPONSE LETTER; AMENDMENTS TO UNAPPROVED APPLICATIONS
Priority: Substantive, Nonsignificant. Major status under 5 USC 801 is
undetermined.
Legal Authority: 21 USC 321; 21 USC 331; 21 USC 351 to 353; 21 USC 355;
21 USC 371; 21 USC 374; 21 USC 379e
CFR Citation: 21 CFR 312; 21 CFR 314
Legal Deadline: None
Abstract: The proposed rule would amend the regulations on marketing
approval of new drugs to discontinue the use of approvable and not
approvable letters when taking action on a marketing application and
instead use complete response letters. The proposed rule would also
amend the regulations on extension of the review clock because of
amendments to applications.
Timetable:
________________________________________________________________________
Action                            Date                      FR Cite
________________________________________________________________________
NPRM                            07/20/04                    69 FR 43357
Final Action                    04/00/06
Regulatory Flexibility Analysis Required: No
Small Entities Affected: No
Government Levels Affected: None
Agency Contact: Brian L. Pendleton, Regulatory Counsel, Department of
Health and Human Services, Food and Drug Administration, 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
_______________________________________________________________________
1036. CGMPS FOR BLOOD AND BLOOD COMPONENTS: NOTIFICATION OF CONSIGNEES
AND TRANSFUSION RECIPIENTS RECEIVING BLOOD AND BLOOD COMPONENTS AT
INCREASED RISK OF TRANSMITTING HCV INFECTION (LOOKBACK)
Priority: Other Significant
Legal Authority: 21 USC 321; 21 USC 331; 21 USC 351 to 353; 21 USC 355;
21 USC 360; 21 USC 360c; 21 USC 360d; 21 USC 360h to 360j; 21 USC 371;
21 USC 374; 42 USC 216; 42 USC 262; 42 USC 263a; 42 USC 264; 21 USC
372; 21 USC 381; 42 USC 263
CFR Citation: 21 CFR 606; 21 CFR 610
Legal Deadline: None
Abstract: This rulemaking is one of a number of actions being taken to
amend the biologics regulations to remove, revise, or update the
regulations applicable to blood, blood components, and blood
derivatives. These actions are based on FDA's comprehensive review of
the biologics regulations and on reports by the U.S. House of
Representatives Committee on Government Reform and Oversight's,
Subcommittee on House Resources and Intergovernmental Relations, the
General Accounting Office, and the Institute of Medicine, as well as on
public comments. In this rulemaking, FDA will amend the biologics
regulations to require that blood establishments prepare and follow
written procedures for appropriate action when it is determined that
blood and blood components pose an increased risk for transmitting
hepatitis C virus (HCV) infection because they have been collected from
a donor who, at a later date, tested reactive for evidence of HCV. The
HIV lookback regulations will be amended for consistency.
Timetable:
________________________________________________________________________
Action                            Date                      FR Cite
________________________________________________________________________
NPRM                            11/16/00                    65 FR 69377
NPRM Comment Period End         02/14/01
Final Action                    12/00/05
Regulatory Flexibility Analysis Required: No
Small Entities Affected: Businesses
Government Levels Affected: None
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
Email: mckeever@cber.fda.gov
Related RIN: Related to 0910-AB26
RIN: 0910-AB76
_______________________________________________________________________
1037. CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKING, OR
HOLDING DIETARY INGREDIENTS AND DIETARY SUPPLEMENTS
 Regulatory Plan: This entry is Seq. No. 48 in part II of this issue of
the Federal Register.
RIN: 0910-AB88
[[Page 64578]]
_______________________________________________________________________
1038. ADDITIONAL SAFEGUARDS FOR CHILDREN IN CLINICAL INVESTIGATIONS OF
FDA-REGULATED PRODUCTS
Priority: Other Significant. Major status under 5 USC 801 is
undetermined.
Unfunded Mandates: Undetermined
Legal Authority: 21 USC 321; 21 USC 343; 21 USC 346; 21 USC 346a; 21
USC 348; 21 USC 350a; 21 USC 350b; 21 USC 351 to 353; 21 USC 355; 21
USC 360; 21 USC 360c to 360f; 21 USC 360h to 360j; 21 USC 371; 21 USC
379e; 21 USC 381; 41 USC 216; 41 USC 241; 41 USC 262; 41 USC 263b to
263n
CFR Citation: 21 CFR 50; 21 CFR 56
Legal Deadline: None
Abstract: The final rule will finalize the interim rule that published
in April 2001, providing additional protections for children involved
as subjects in clinical investigations of FDA-regulated products, as
required by the Children's Health Act of 2000.
Timetable:
________________________________________________________________________
Action                            Date                      FR Cite
________________________________________________________________________
Interim Rule                    04/24/01                    66 FR 20589
Final Action                    06/00/06
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, 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
_______________________________________________________________________
1039. PREVENTION OF SALMONELLA ENTERITIDIS IN SHELL EGGS
Priority: Economically Significant. Major under 5 USC 801.
Unfunded Mandates: This action may affect the private sector under PL
104-4.
Legal Authority: 21 USC 321; 21 USC 342; 21 USC 371; 21 USC 381; 21 USC
393; 42 USC 243; 42 USC 264; 42 USC 271; . . .
CFR Citation: 21 CFR 16; 21 CFR 116; 21 CFR 118
Legal Deadline: None
Abstract: In July 1999, the Food and Drug Administration (FDA) and the
Food Safety Inspection Service (FSIS) committed to developing an action
plan to address the presence of salmonella enteritidis (SE) in shell
eggs and egg products using a farm-to-table approach. FDA and FSIS held
a public meeting on August 26, 1999, to obtain stakeholder input on the
draft goals, as well as to further develop the objectives and action
items for the action plan. The Egg Safety Action Plan was announced on
December 11, 1999. The goal of the Action Plan is to reduce egg-related
SE illnesses by 50 percent by 2005 and eliminate egg-related SE
illnesses by 2010.
The Egg Safety Action Plan consists of eight objectives covering all
stages of the farm-to-table continuum as well as support functions. On
March 30, 2000 (Columbus, OH), April 6, 2000 (Sacramento, CA), and July
31, 2000 (Washington, DC), joint public meetings were held by FDA and
FSIS to solicit and discuss information related to the implementation
of the objectives in the Egg Safety Action Plan.
On September 22, 2004, FDA published a proposed rule that would require
egg safety measures to prevent the contamination of shell eggs with SE
during egg production. This proposal would reduce SE prevalence in the
egg production environment and consequently in the eggs themselves.
Most SE contamination of eggs is a result of SE infection in the laying
hen's reproductive tract, called transovarian contamination. The
proposed measures are designed to reduce the likelihood of this
transovarian contamination and include: (1) Provisions for procurement
of chicks and pullets; (2) a biosecurity program; (3) a rodent and pest
control program; (4) cleaning and disinfection of poultry houses that
have had an environmental or egg test positive for SE; (5) egg testing
when an environmental test is positive; and (6) refrigerated storage of
eggs held at the farm.
Additionally, to verify that the measures have been effective, the rule
proposes that producers test the poultry house environment for SE. If
the environmental test is positive, eggs from that environment must be
tested for SE, and if the egg test is positive, the eggs must be
diverted to egg products processing or a treatment process that
achieves at least a 5-log destruction of SE.
The proposed rule is one step in a broader farm-to-table egg safety
effort that includes FDA's requirements for safe handling statements on
egg cartons and refrigerated storage of shell eggs at retail and egg
safety education for consumers and retail establishments. The rule had
a 90-day comment period, which ended December 21, 2004. To discuss the
proposed rule and solicit comments from interested stakeholders, FDA
held three public meetings: October 28, 2004, in College Park, MD;
November 9, 2004, in Chicago, IL; and November 16, 2004, in Los
Angeles, CA.
The comment period was reopened until July 25, 2005 to solicit further
comment and information on industry practices and programs that prevent
SE monitored chicks from becoming infected by SE during the period of
pullet rearing until placement into laying hen houses.
Timetable:
________________________________________________________________________
Action                            Date                      FR Cite
________________________________________________________________________
NPRM                            09/22/04                    69 FR 56824
Final Action                    07/00/06
Regulatory Flexibility Analysis Required: Yes
Small Entities Affected: Businesses
Government Levels Affected: Undetermined
Agency Contact: Louis J. Carson, Deputy Director, Food Safety
Initiative, Department of Health and Human Services, Food and Drug
Administration, Center for Food Safety and Applied Nutrition (HFS-032),
5100 Paint Branch Parkway, College Park, MD 20740
Phone: 301 436-2130
Fax: 301 436-2632
Email: louis.carson@cfsan.fda.gov
RIN: 0910-AC14
_______________________________________________________________________
1040. 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
[[Page 64579]]
CFR Citation: 21 CFR 56.106
Legal Deadline: None
Abstract: The final rule would require institutional review boards
(IRB) to register with FDA. The registration information would include
the name of the IRB, the name of the institution operating the IRB, and
names, addresses, phone numbers, facsimile (fax) numbers, and
electronic mail (e-mail) addresses of the senior officer of the
institution and IRB chair or contact, the range of active protocols
(small, medium, or large) involving FDA-regulated products reviewed in
the previous calendar year, and a description of the types of FDA-
regulated products reviewed. The final rule would make it easier for
FDA to inspect IRBs and to convey information to IRBs.
Timetable:
________________________________________________________________________
Action                            Date                      FR Cite
________________________________________________________________________
NPRM                            07/06/04                    69 FR 40556
Final Action                    03/00/06
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 (HF-23), 5600 Fishers Lane, Room
14C-17, Rockville, MD 20857
Phone: 301 827-0587
Fax: 301 827-4774
Email: philip.chao@fda.hhs.gov
RIN: 0910-AC17
_______________________________________________________________________
1041. 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: This interim final rule will add an exception from the
general requirement for informed consent in certain circumstances
involving the use of investigational in vitro diagnostic devices to
identify chemical, biological, radiological, or nuclear agents in a
potential terrorist event or other public health emergency.
Timetable:
________________________________________________________________________
Action                            Date                      FR Cite
________________________________________________________________________
Interim Final Rule              06/00/06
Regulatory Flexibility Analysis Required: No
Small Entities Affected: No
Government Levels Affected: None
Agency Contact: Catherine Lorraine, Director, Policy Development and
Coordination Group, Office of Policy and Planning, Department of Health
and Human Services, Food and Drug Administration, 14-101-11, 5600
Fishers Lane, Rockville, MD 20857
Phone: 301 827-3360
Fax: 301 594-6777
RIN: 0910-AC25
_______________________________________________________________________
1042. 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 final rule amends 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 rule would clarify sampling plans and the scoring of defects,
lower acceptance rates for leaking gloves, raise rejection rates for
leaking gloves, and add tightened inspection schemes for reexamined
glove lots. The rule is intended to facilitate industry compliance and
enhance the safety and effectiveness of gloves.
Timetable:
________________________________________________________________________
Action                            Date                      FR Cite
________________________________________________________________________
NPRM                            03/31/03                    68 FR 15404
NPRM Comment Period End         06/30/03
Final Action                    12/00/05
Regulatory Flexibility Analysis Required: No
Government Levels Affected: Undetermined
Federalism:  Undetermined
Agency Contact: Myrna Hanna, Regulations Staff, Department of Health
and Human Services, Food and Drug Administration, Center for Devices
and Radiological Health, HFZ-215, 1350 Piccard Drive, Rockville, MD
20850
Phone: 301 827-2971
Fax: 301 594-4765
Email: myh@fda.hhs.gov
RIN: 0910-AC32
_______________________________________________________________________
1043. TOLL-FREE NUMBER FOR REPORTING ADVERSE EVENTS ON LABELING FOR
HUMAN DRUGS
 Regulatory Plan: This entry is Seq. No. 49 in part II of this issue of
the Federal Register.
RIN: 0910-AC35
_______________________________________________________________________
1044. PRIOR NOTICE OF IMPORTED FOOD UNDER THE PUBLIC HEALTH SECURITY AND
BIOTERRORISM PREPAREDNESS AND RESPONSE ACT OF 2002
Priority: Other Significant. Major under 5 USC 801.
Legal Authority: PL 107-188, sec 307
CFR Citation: 21 CFR 1.276 et seq
Legal Deadline: Final, Statutory, December 12, 2003.
The Public Health Security and Bioterrorism Preparedness and Response
Act of 2002, section 307, directs the Secretary, through FDA, to issue
final regulations establishing prior notice requirements for all
imported food by December 12, 2003. If FDA fails to issue final
regulations by this date, the statute is self-executing on this date,
and requires FDA to receive prior notice of not less than eight hours,
nor more than five days until final regulations are issued.
Abstract: This rulemaking is one of a number of actions being taken to
improve FDA's ability to respond to threats of bioterrorism. Section
801(m) of the Federal Food, Drug, and Cosmetic Act (FFDCA), which was
added by section 307 of the Public Health Security and Bioterrorism
Preparedness and Response Act of 2002 (the Bioterrorism Act), requires
notification to FDA prior to the entry of imported food. The required
prior notice would provide the identity of
[[Page 64580]]
the article of food; the manufacturer; the shipper; the grower, if
known at the time of notification; the originating country; the
shipping country; and the anticipated port of entry. The regulation
identifies the parties responsible for providing the notice and
explains the information that the prior notice is required to contain,
the method of submission of the notice, and the minimum and maximum
period of advance notice required. Section 307 also states that if FDA
does not receive prior notice or receives inadequate prior notice, the
imported food shall be refused admission and held at the port of entry
until proper notice is provided.
Section 307 authorizes the Secretary, through FDA, to promulgate final
regulations by December 12, 2003. FDA and CBP issued an interim final
rule (IFR) on October 10, 2003 (68 FR 58974). The IFR originally
provided a 75-day comment period to ensure that those that comment on
the IFR have the benefit of our outreach and educational efforts and
have the experience with the systems, timeframes, and data elements. We
reopened the comment period for an additional 90 days in April through
July 2004 to allow for additional comment on the industry's experience
with the prior notice system, and comment on the Joint FDA-CBP Plan for
Increasing Integration and Assessing the Coordination of Prior Notice
Timeframes. The final rule currently is under development, and it will
confirm or amend the IFR, as appropriate. This final rule is not
expected to have a significant impact on a substantial number of small
entities.
Timetable:
________________________________________________________________________
Action                            Date                      FR Cite
________________________________________________________________________
NPRM                            02/03/03                     68 FR 5428
Interim Final Rule              10/10/03                    68 FR 58974
Interim Final Rule Comment
Period Reopened                 04/14/04                    69 FR 19763
Interim Final Rule Comment
Period Reopened End             07/13/04
Final Rule                      07/00/06
Regulatory Flexibility Analysis Required: Yes
Small Entities Affected: Businesses
Government Levels Affected: Federal
Agency Contact: May Nelson, Regulatory Counsel, Department of Health
and Human Services, Food and Drug Administration, HFS-32, Center for
Food Safety and Applied Nutrition, 5100 Paint Branch Parkway, College
Park, MD 20740
Phone: 301 436-1722
Fax: 301 436-2637
Email: may.nelson@cfsan.fda.gov
RIN: 0910-AC41
_______________________________________________________________________
1045. HUMAN SUBJECT PROTECTION; FOREIGN CLINICAL STUDIES NOT CONDUCTED
UNDER AN INVESTIGATIONAL NEW DRUG APPLICATION
Priority: Substantive, Nonsignificant. Major status under 5 USC 801 is
undetermined.
Legal Authority: 21 USC 355(d)(5); 21 USC 355(i); 21 USC 371(a); 42 USC
262(a)(2)(A); 42 USC 262(a)(2)(B)(i)(l)
CFR Citation: 21 CFR 312.120
Legal Deadline: None
Abstract: This final rule follows a proposed rule, which proposed to
update the standards for the acceptance of foreign clinical studies not
conducted under an investigational new drug application (IND) as
support for an IND or marketing application for a drug or biological
product. We proposed to replace the requirement in 21 CFR 312.120 that
non-IND foreign clinical studies be conducted in accordance with
ethical principles stated in the Declaration of Helsinki or with the
laws and regulations of the country that is the research site,
whichever provide greater protection to subjects. We would replace that
with a requirement that such studies be conducted in accordance with
good clinical practice (GCP), including review and approval by an
independent ethics committee. The proposed GCP standard is consistent
with the standard of the International Conference on Harmonisation of
Technical Requirements for Registration of Pharmaceuticals for Human
Use for GCP and is sufficiently flexible to accommodate differences in
how countries regulate the conduct of clinical research and obtain the
informed consent of patients.
Timetable:
________________________________________________________________________
Action                            Date                      FR Cite
________________________________________________________________________
NPRM                            06/10/04                    69 FR 32467
Final Action                    04/00/06
Regulatory Flexibility Analysis Required: No
Small Entities Affected: No
Government Levels Affected: None
Agency Contact: Brian L. Pendleton, Regulatory Counsel, Department of
Health and Human Services, Food and Drug Administration, Suite 3037
(HFD-7), Center for Drug Evaluation and Research, 5515 Security Lane,
Suite 1101 (HFD-7), Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562
Email: pendletonb@cder.fda.gov
RIN: 0910-AF15
_______________________________________________________________________
1046. BLOOD INITIATIVE--REVISIONS TO LABELING REQUIREMENTS FOR BLOOD AND
BLOOD COMPONENTS, INCLUDING SOURCE PLASMA; AND TECHNICAL AMENDMENT
Priority: Other Significant
Legal Authority: 21 USC 321; 21 USC 360j; 21 USC 351 to 353; 21 USC
355; 21 USC 360; 21 USC 371; 21 USC 374; 42 USC 216; 42 USC 262; 42 USC
263; 42 USC 263a; 42 USC 264; 42 USC 300aa to 25; 21 USC 331; 21 USC
310
CFR Citation: 21 CFR 606; 21 CFR 610; 21 CFR 640
Legal Deadline: None
Abstract: The Food and Drug Administration (FDA) is amending the
regulations regarding container labels and instruction circulars for
certain blood, blood components, including 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.
Timetable:
________________________________________________________________________
Action                            Date                      FR Cite
________________________________________________________________________
NPRM                            07/30/03                    68 FR 44678
NPRM Comment Period End         10/28/03
Final Action                    06/00/06
Regulatory Flexibility Analysis Required: No
[[Page 64581]]
Small Entities Affected: No
Government Levels Affected: None
Agency Contact: Brenda R. Friend, Regulatory Counsel, Department of
Health and Human Services, Food and Drug Administration, Center for
Biologics Evaluation and Research, HFM-17, 1410 Rockville Pike, Suite
200N, Rockville, MD 20852-1448
Phone: 301 827-6210
Fax: 301 827-9434
Related RIN: Split from 0910-AB26
RIN: 0910-AF26
_______________________________________________________________________
1047. INFANT FORMULA: CURRENT GOOD MANUFACTURING PRACTICES; QUALITY
CONTROL PROCEDURES; NOTIFICATION REQUIREMENTS; RECORDS AND REPORTS
Priority: Other Significant
Legal Authority: 21 USC 321; 21 USC 350a; 21 USC 371; . . .
CFR Citation: 21 CFR 106; 21 CFR 107
Legal Deadline: None
Abstract: The agency published a proposed rule on July 9, 1996, that
would establish current good manufacturing practice regulations,
quality control procedures, quality factors, notification requirements,
and records and reports for the production of infant formula. This
proposal was issued in response to the 1986 Amendments to the Infant
Formula Act of 1980. On April 28, 2003, FDA reopened the comment period
to update comments on the proposal. The comment period was extended on
June 27, 2003, to end on August 26, 2003.
Timetable:
________________________________________________________________________
Action                            Date                      FR Cite
________________________________________________________________________
NPRM                            07/09/96                    61 FR 36154
NPRM Comment Period End         12/06/96
Other/NPRM Comment Period
Reopened                        04/28/03                    68 FR 22341
Other/NPRM Comment Period
Extended                        06/27/03                    68 FR 38247
NPRM Comment Period End         08/26/03
Final Action                    09/00/06
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-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
_______________________________________________________________________
1048. INFANT FORMULA QUALITY FACTORS
Priority: Other Significant
Legal Authority: 21 USC 321; 21 USC 350a; 21 USC 371; . . .
CFR Citation: 21 CFR 106; 21 CFR 107
Legal Deadline: None
Abstract: The agency published a proposed rule on July 9, 1996, that
would establish current good manufacturing practice regulations,
quality control procedures, quality factors, notification requirements,
and records and reports for the production of infant formula. This
proposal was issued in response to the 1986 Amendments to the Infant
Formula Act of 1980. On April 28, 2003, FDA reopened the comment period
to update comments on the proposal. The comment period was extended on
June 27, 2003, to end on August 26, 2003.
Timetable:
________________________________________________________________________
Action                            Date                      FR Cite
________________________________________________________________________
NPRM                            07/09/96                    61 FR 36154
NPRM Comment Period End         12/06/96
Other/NPRM Comment Period
Reopened                        04/28/03                    68 FR 22341
Other/NPRM Comment Period
Extended                        06/27/03                    68 FR 38247
NPRM Comment Period End         08/26/03
Final Action                    09/00/06
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-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
_______________________________________________________________________
1049. 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)                           12/00/05
Regulatory Flexibility Analysis Required: Yes
Small Entities Affected: Businesses
Government Levels Affected: None
Agency Contact: Gerald M. Rachanow, Regulatory Counsel, Division of
Over-the-Counter Drug Products, Department of Health and Human
Services, Food and Drug Administration, 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
[[Page 64582]]
_______________________________________________________________________
1050. 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)     12/00/05
Final Action (Amendment)
(Sinusitis Claim)               10/31/05                    70 FR 58974
Final Action (Phenyl
propanolamine)                  10/00/06
Final Action (Phenylephrine
Bitartrate)                     12/00/05
Regulatory Flexibility Analysis Required: Yes
Small Entities Affected: Businesses
Government Levels Affected: None
Agency Contact: Gerald M. Rachanow, Regulatory Counsel, Division of
Over-the-Counter Drug Products, Department of Health and Human
Services, Food and Drug Administration, 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
_______________________________________________________________________
1051. 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:
________________________________________________________________________
Action                            Date                      FR Cite
________________________________________________________________________
Final Action (Laxative Drug
Products)                       03/00/06
Final Action (Granular Psyllium)10/00/06
Regulatory Flexibility Analysis Required: Yes
Small Entities Affected: Businesses
Government Levels Affected: None
Agency Contact: Gerald M. Rachanow, Regulatory Counsel, Division of
Over-the-Counter Drug Products, Department of Health and Human
Services, Food and Drug Administration, 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
_______________________________________________________________________
1052. OVER-THE-COUNTER (OTC) DRUG REVIEW--SKIN PROTECTANT PRODUCTS
Priority: Routine and Frequent
Legal Authority: 21 USC 321p; 21 USC 351 to 353; 21 USC 355; 21 USC
360a; 21 USC 371a; 21 USC 331; 21 USC 360; 21 USC 371
CFR Citation: 21 CFR 201; 21 CFR 310; 21 CFR 330 to 358
Legal Deadline: None
Abstract: The OTC drug review establishes conditions under which OTC
drugs are considered generally recognized as safe and effective and not
misbranded. After a final monograph (i.e. final rule) is issued, only
OTC drugs meeting the conditions of the monograph, or having an
approved new drug application, may be legally marketed. One action
addresses labeling for products formulated and marketed as lip
protectants. The second action addresses skin protectant products to
protect and treat fever blisters and cold sores.
Timetable:
________________________________________________________________________
Action                            Date                      FR Cite
________________________________________________________________________
Final Action (Technical
Amendments)                     12/00/05
Final Action (Fever Blisters/
Cold Sores)                     10/00/06
Final Action (Diaper Rash)      03/00/06
NPRM (Amendment) (Diaper Rash
Drug Product)                   10/00/06
Regulatory Flexibility Analysis Required: Yes
Small Entities Affected: Businesses
Government Levels Affected: None
Agency Contact: Gerald M. Rachanow, Regulatory Counsel, Division of
Over-the-Counter Drug Products, Department of Health and Human
Services, Food and Drug Administration, 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
_______________________________________________________________________
1053. OVER-THE-COUNTER (OTC) DRUG REVIEW--VAGINAL CONTRACEPTIVE PRODUCTS
Priority: Routine and Frequent
Legal Authority: 21 USC 321p; 21 USC 351 to 353; 21 USC 355; 21 USC
360a; 21 USC 371a; 21 USC 331; 21 USC 358; 21 USC 360; 21 USC 360gg to
360ss; 21 USC 371; 21 USC 374; 21 USC 379e; 42 USC 216; 42 USC 241; 42
USC 262; 42 USC 264
CFR Citation: 21 CFR 201; 21 CFR 310; 21 CFR 330 to 358
[[Page 64583]]
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)         12/00/05
NPRM (Vaginal Contraceptive Drug
Products)                       10/00/06
Regulatory Flexibility Analysis Required: Yes
Small Entities Affected: Businesses
Government Levels Affected: None
Agency Contact: Gerald M. Rachanow, Regulatory Counsel, Division of
Over-the-Counter Drug Products, Department of Health and Human
Services, Food and Drug Administration, 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
_______________________________________________________________________
1054. USE OF MATERIALS DERIVED FROM CATTLE IN HUMAN FOOD AND COSMETICS
Priority: Other Significant
Legal Authority: 21 USC 342; 21 USC 361; 21 USC 371
CFR Citation: 21 CFR 189.5; 21 CFR 700.27
Legal Deadline: None
Abstract: On July 14, 2004, FDA issued an interim final rule, effective
immediately, to prohibit the use of certain cattle material, to address
the potential risk of bovine spongiform encephalopathy (BSE), in human
food, including dietary supplements, and cosmetics. Prohibited cattle
materials include specified risk materials, small intestine of all
cattle, material from nonambulatory disabled cattle, material from
cattle not inspected and passed for human consumption, and mechanically
separated (MS) (Beef). Specified risk materials are the brain, skull,
eyes, trigeminal ganglia, spinal cord, vertebral column (excluding the
vertebrae of the tail, the transverse processes of the thoracic and
lumbar vertebrae, and the wings of the sacrum), and dorsal root ganglia
of cattle 30 months and older; and the tonsils and distal ileum of the
small intestine of all cattle. Prohibited cattle materials do not
include tallow that contains no more than 0.15 percent hexane-insoluble
impurities and tallow derivatives. This action minimizes human exposure
to materials that scientific studies have demonstrated are highly
likely to contain the BSE agent in cattle infected with the disease.
Scientists believe that the human disease variant Creutzfeldt-Jakob
disease (vCJD) is likely caused by the consumption of products
contaminated with the agent that causes BSE. After reviewing comments
received to the interim final rule, FDA intends to issue a final rule.
Timetable:
________________________________________________________________________
Action                            Date                      FR Cite
________________________________________________________________________
Interim Final Rule              07/14/04                    69 FR 42256
Interim Final Rule Comment
Period End                      10/12/04
Final Action                    07/00/06
Interim Final Rule (Ammendments)09/07/05                    70 FR 53063
Interim Final Rule (Ammendments)
Comment Period End              11/07/05
Regulatory Flexibility Analysis Required: No
Small Entities Affected: No
Government Levels Affected: None
Agency Contact: Rebecca Buckner, Consumer Safety Officer, Department of
Health and Human Services, Food and Drug Administration, 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-AF47
_______________________________________________________________________
1055. RECORDKEEPING REQUIREMENTS FOR HUMAN FOOD AND COSMETICS
MANUFACTURED FROM, PROCESSED WITH, OR OTHERWISE CONTAINING MATERIAL FROM
CATTLE
Priority: Other Significant
Legal Authority: 21 USC 342; 21 USC 361; 21 USC 371; 21 USC 381
CFR Citation: 21 CFR 189.5; 21 CFR 700.27
Legal Deadline: None
Abstract: On July 14, 2004, FDA proposed to require that manufacturers
and processors of human food and cosmetics that are manufactured from,
processed with, or otherwise contain, material from cattle must
establish and maintain records sufficient to demonstrate the food or
cosmetic is not manufactured from, processed with, or does not
otherwise contain, prohibited cattle materials. This is a companion
rulemaking to FDA's interim final rule entitled ``Use of Materials
Derived From Cattle in Human Food and Cosmetics.`` FDA intends to
finalize this proposal after reviewing any comments received.
Timetable:
________________________________________________________________________
Action                            Date                      FR Cite
________________________________________________________________________
NPRM                            07/14/04                    69 FR 42275
NPRM Comment Period End         08/13/04
Final Action                    12/00/05
Regulatory Flexibility Analysis Required: No
Small Entities Affected: Businesses
Government Levels Affected: None
Agency Contact: Rebecca Buckner, Consumer Safety Officer, Department of
Health and Human Services, Food and Drug Administration, 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-AF48
_______________________________________________________________________
1056. OVER-THE-COUNTER (OTC) DRUG REVIEW--ANTACID PRODUCTS
Priority: Routine and Frequent
Legal Authority: 21 USC 321p; 21 USC 351 to 353; 21 USC 355; 21 USC
360; 21 USC 360a; 21 USC 371; 21 USC 371a; 21 USC 331
[[Page 64584]]
CFR Citation: 21 CFR 201; 21 CFR 310; 21 CFR 330 to 358
Legal Deadline: None
Abstract: The OTC drug review establishes conditions under which OTC
drugs are considered generally recognized as safe and effective and not
misbranded. After a final monograph (i.e. final rule) is issued, only
OTC drugs meeting the conditions of the monograph, or having an
approved new drug application, may be legally marketed. One action
addresses the labeling of products containing sodium bicarbonate as an
active ingredient. The other action addresses the use of antacids to
relieve upset stomach associated with overindulgence in food and drink.
Timetable:
________________________________________________________________________
Action                            Date                      FR Cite
________________________________________________________________________
Final Action (Sodium Bicarbonate
Labeling)                       01/00/06
Final Action (Overindulgence
Labeling)                       01/00/06
Regulatory Flexibility Analysis Required: Yes
Small Entities Affected: Businesses
Government Levels Affected: None
Agency Contact: Gerald M. Rachanow, Regulatory Counsel, Division of
Over-the-Counter Drug Products, Department of Health and Human
Services, Food and Drug Administration, 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
_______________________________________________________________________
1057. SUPPLEMENTS AND OTHER CHANGES TO APPROVED NEW ANIMAL DRUG
APPLICATIONS
Priority: Substantive, Nonsignificant
Legal Authority: 21 USC 356a
CFR Citation: 21 CFR 25; 21 CFR 500; 21 CFR 514; 21 CFR 558
Legal Deadline: None
Abstract: The Food and Drug Administration (FDA) is amending its
regulations on supplements and other changes to approved new animal
drug applications (NADAs) or abbreviated new animal drug applications
(ANADAs) to implement the manufacturing changes provision of the Food
and Drug Modernization Act of 1997. The final rule requires
manufacturers to assess the effect of a manufacturing change on the
identity, strength, quality, purity, and potency of a drug as those
factors relate to the safety or effectiveness of the drug. The final
rule sets forth requirements for changes requiring submission and
approval of a supplement before the distribution of the drug made using
the change, changes requiring the submission of a supplement at least
30 days prior to the distribution of the drug, changes requiring the
submission of a supplement at the time of distribution of the drug, and
changes to be described in an annual report.
Timetable:
________________________________________________________________________
Action                            Date                      FR Cite
________________________________________________________________________
NPRM                            10/01/99                    64 FR 53281
Final Action                    01/00/06
Final Action Effective          03/00/06
Regulatory Flexibility Analysis Required: No
Small Entities Affected: Businesses
Government Levels Affected: None
Agency Contact: Dennis Bensley Jr., Chemist, Department of Health and
Human Services, Food and Drug Administration, 7500 Standish Place, MPN-
2, Room 320, HFV-140, Rockville, MD 20855
Phone: 301 827-6956
Email: dbensley@cvm.fda.gov
RIN: 0910-AF59
_______________________________________________________________________
1058. BIOLOGICAL PRODUCTS; BACTERIAL VACCINES AND TOXOIDS;
IMPLEMENTATION OF EFFICACY REVIEW
Priority: Substantive, Nonsignificant
Legal Authority: 21 USC 321; 21 USC 331; 21 USC 351 to 353; 21 USC 355;
21 USC 358; 21 USC 360; 21 USC 360b to 360d; 21 USC 360h; 21 USC 360i;
21 USC 360gg to 360ss; 21 USC 371; 21 USC 372; 21 USC 374; 21 USC 379e;
21 USC 381; 42 USC 216; 42 USC 241; 42 USC 262; 42 USC 263; 42 USC
263a; 42 USC 264
CFR Citation: 21 CFR 201.59; 21 CFR 610.21
Legal Deadline: None
Abstract: On December 13, 1985, the Food and Drug Administration (FDA)
proposed to amend the biologics regulations and proposed to classify
the bacterial vaccines and toxoids on the basis of findings and
recommendations of the Panel on Review of Bacterial Vaccines and
Toxoids (the Panel). The Panel reviewed the safety, efficacy, and
labeling of bacterial vaccines and toxoids with standards of potency,
bacterial antitoxins, and immune globulins. After reviewing the Panel's
report and comments on the proposal, FDA published a final rule and
final order on January 5, 2004 (69 FR 255). On October 27, 2004, the
United States District Court for the District of Columbia vacated the
January 5, 2004, final rule and final order. On December 29, 2004 (69
FR 78280), FDA published a withdrawal of the January 5, 2004, final
rule and final order. Concurrently with the withdrawal of the final
rule and final order, FDA published again a proposed rule and proposed
order (December 2004 proposal) (69 FR 78281) to provide notice and to
give interested persons an opportunity to comment. FDA is proposing to
amend the biologics regulations in response to the report and
recommendations of the Panel and in consideration of comments submitted
to the Division of Dockets Management. FDA intends to classify these
products as Category I (safe, effective, and not misbranded), Category
II (unsafe, ineffective, or misbranded), or Category IIIB (off the
market pending completion of studies permitting a determination of
effectiveness).
The December 2004 proposal included a proposed order for Anthrax
Vaccine Absorbed. The final order Anthrax Vaccine Absorbed will be
published separately in the same issue of the Federal Register as the
final rule and final order for the other products included in the
December 2004 proposal.
Timetable:
________________________________________________________________________
Action                            Date                      FR Cite
________________________________________________________________________
NPRM                            12/29/04                    69 FR 78281
NPRM Comment Period End         03/29/05
Final Action                    12/00/05
Regulatory Flexibility Analysis Required: No
Small Entities Affected: No
Government Levels Affected: None
Agency Contact: Astrid L. Szeto, Senior Regulatory Review Officer,
[[Page 64585]]
Department of Health and Human Services, Food and Drug Administration,
Center for Biologics Evaluation and Research, 1401 Rockville Pike,
Suite 200N, HFM-17, Rockville, MD 20852
Phone: 301 827-6210
Fax: 301-827-9434
RIN: 0910-AF62
_______________________________________________________________________
Department of Health and Human Services (HHS)         Long-Term Actions
Food and Drug Administration (FDA)
_______________________________________________________________________
1059. 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: Christine F. Rogers, 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,
Rockville, MD 20857
Phone: 301 594-2041
Fax: 301 827-5562
RIN: 0910-AC23
_______________________________________________________________________
1060. FOOD LABELING: TRANS FATTY ACIDS IN NUTRITION LABELING: CONSUMER
RESEARCH TO CONSIDER NUTRIENT CONTENT AND HEALTH CLAIMS AND POSSIBLE
FOOTNOTE OR DISCLOSURE STATEMENTS
Priority: Other Significant
Legal Authority: 21 USC 321; 21 USC 343; 21 USC 371
CFR Citation: 21 CFR 101
Legal Deadline: None
Abstract: The Food and Drug Administration issued an advance notice of
proposed rulemaking on July 11, 2003 (68 FR 41507), to solicit
information and data that potentially could be used to establish new
nutrient content claims about trans fatty acids; to establish
qualifying criteria for trans fat in current nutrient content claims
for saturated fat and cholesterol, lean and extra lean claims, and
health claims that contain a message about cholesterol-raising lipids;
and, in addition, to establish disclosure and disqualifying criteria to
help consumers make heart-healthy food choices. The agency also
requested comments on whether it should consider statements about trans
fat, either alone or in 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: Undetermined
Government Levels Affected: Federal
Agency Contact: Julie Moss, Consumer Safety Officer, Department of
Health and Human Services, Food and Drug Administration, HFS-830,
Center for Food Safety and Applied Nutrition, 5100 Paint Branch
Parkway, College Park, MD 20740
Phone: 301 436-2373
Fax: 301 436-2639
Email: julie.moss@fda.gov
Related RIN: Related to 0910-AB66
RIN: 0910-AC50
_______________________________________________________________________
1061. 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
[[Page 64586]]
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 proposed a set of general
principles that define how modern food standards should be structured
(70 FR 29214, May 20, 2005). If this proposed rule is adopted, FDA and
FSIS will require that a citizen petition for establishing, revising,
or eliminating a food standard in 21 CFR parts 130 to 169 and 9 CFR
part 319 be submitted in accordance with the general principles.
Conversely, the agencies may find deficient a petition to establish,
revise, or eliminate a food standard that does not follow these general
principles.
Timetable:
________________________________________________________________________
Action                            Date                      FR Cite
________________________________________________________________________
ANPRM                           12/29/95                    60 FR 67492
ANPRM Comment Period End        04/29/96
NPRM                            05/20/05                    70 FR 29214
NPRM Comment Period End         08/18/05
Final Action                     To Be                       Determined
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
_______________________________________________________________________
1062. CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PROCESSING,
PACKING, OR HOLDING OF DRUGS; REVISION OF CERTAIN LABELING CONTROLS
Priority: Substantive, Nonsignificant. Major status under 5 USC 801 is
undetermined.
Unfunded Mandates: Undetermined
Legal Authority: 21 USC 351
CFR Citation: 21 CFR 211.122
Legal Deadline: None
Abstract: The proposed rule would amend the packaging and labeling
control provisions of the current good manufacturing practice
regulations for human and veterinary drug products by limiting the
application of special control procedures for the use of cut labeling
to immediate container labels, individual unit cartons, or multiunit
cartons containing immediate containers that are not packaged in
individual unit cartons. The proposal would also permit the use of any
automated technique, including differentiation by labeling size and
shape, that physically prevents incorrect labeling from being processed
by labeling and packaging equipment when cut labeling is used.
Timetable:
________________________________________________________________________
Action                            Date                      FR Cite
________________________________________________________________________
NPRM                            07/29/97                    62 FR 40489
Final Action                     To Be                       Determined
Regulatory Flexibility Analysis Required: Undetermined
Small Entities Affected:  Businesses
Government Levels Affected: None
Federalism:  Undetermined
Agency Contact: Howard P. Muller, Office of Regulatory Policy,
Department of Health and Human Services, Food and Drug Administration,
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
_______________________________________________________________________
1063. 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                             To Be                       Determined
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
[[Page 64587]]
_______________________________________________________________________
1064. FOOD LABELING; PROMINENCE OF CALORIES
Priority: Other Significant
Legal Authority: 21 USC 321; 21 USC 343; 21 USC 371
CFR Citation: 21 CFR 101.9
Legal Deadline: None
Abstract: In response to the Report of the Working Group on Obesity
(OWG) that FDA issued on March 12, 2004, the agency issued on April 4,
2005, an advance notice of proposed rulemaking (ANPRM) in its efforts
to combat the Nation's obesity problem. The ANPRM requested comments on
ways to give more prominence to ``calories'' on the food label.
Timetable:
________________________________________________________________________
Action                            Date                      FR Cite
________________________________________________________________________
ANPRM                           04/04/05                    70 FR 17008
ANPRM Comment Period End        06/20/05
NPRM                             To Be                       Determined
Regulatory Flexibility Analysis Required: Undetermined
Government Levels Affected: Undetermined
Agency Contact: Jill Kevala, Chemist, Department of Health and Human
Services, Food and Drug Administration, HFS-830, Center for Food Safety
and Applied Nutrition, 5100 Paint Branch Parkway, College Park, MD
20740
Phone: 301 436-1450
Fax: 301 436-2636
Email: jkevala@cfsan.fda.gov
RIN: 0910-AF22
_______________________________________________________________________
1065. FOOD LABELING; SERVING SIZES OF PRODUCTS THAT CAN REASONABLY BE
CONSUMED AT ONE EATING OCCASION; UPDATING OF REFERENCE AMOUNTS
CUSTOMARILY CONSUMED; APPROACHES FOR RECOMMENDING SMALLER PORTION SIZES
Priority: Other Significant
Legal Authority: 21 USC 321; 21 USC 343; 21 USC 371
CFR Citation: 21 CFR 101.9; 21 CFR 101.12; 21 CFR 101.60(b)
Legal Deadline: None
Abstract: In response to the Report of the Working Group on Obesity
that FDA issued on March 12, 2004, the agency issued on April 4, 2005,
an advance notice of proposed rulemaking (ANPRM) in its efforts to
combat the Nation's obesity problem. The ANPRM requested comments on
changes to the agency's nutrition labeling regulations on serving size
and comments on allowance of truthful, nonmisleading, and useful
approaches for promoting consumption of smaller portion sizes.
Timetable:
________________________________________________________________________
Action                            Date                      FR Cite
________________________________________________________________________
ANPRM                           04/04/05                    70 FR 17010
ANPRM Comment Period End        06/20/05
NPRM                             To Be                       Determined
Regulatory Flexibility Analysis Required: Undetermined
Government Levels Affected: Undetermined
Agency Contact: Lori LeGault, Nutritionist, Department of Health and
Human Services, Food and Drug Administration, HFS-840, 5100 Paint
Branch Parkway, College Park, MD 20740
Phone: 301 436-1791
Fax: 301 436-2635
Email: llegault@cfsan.fda.gov
RIN: 0910-AF23
_______________________________________________________________________
1066. 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)                07/13/05                    70 FR 40237
Final Action                     To Be                       Determined
Regulatory Flexibility Analysis Required: Yes
Small Entities Affected: Businesses
Government Levels Affected: None
Agency Contact: Gerald M. Rachanow, Regulatory Counsel, Division of
Over-the-Counter Drug Products, Department of Health and Human
Services, Food and Drug Administration, 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
_______________________________________________________________________
1067. 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)                07/13/05                    70 FR 40232
Final Action                     To Be                       Determined
Regulatory Flexibility Analysis Required: Yes
Small Entities Affected: Businesses
Government Levels Affected: None
Agency Contact: Gerald M. Rachanow, Regulatory Counsel, Division of
Over-the-Counter Drug Products, Department of Health and Human
Services, Food and Drug Administration, Center for Drug Evaluation and
Research, 5600 Fishers Lane, HFD-560, Rockville, MD 20857
Phone: 301 827-2241
[[Page 64588]]
Fax: 301 827-2315
Email: rachanow@cder.fda.gov
Related RIN: Split from 0910-AA01
RIN: 0910-AF33
_______________________________________________________________________
1068. 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, 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
_______________________________________________________________________
1069. 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:
________________________________________________________________________
Action                            Date                      FR Cite
________________________________________________________________________
Final Action (Plaque Gingivitis)10/00/06
Regulatory Flexibility Analysis Required: Yes
Small Entities Affected: Businesses
Government Levels Affected: None
Agency Contact: Gerald M. Rachanow, Regulatory Counsel, Division of
Over-the-Counter Drug Products, Department of Health and Human
Services, Food and Drug Administration, 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
_______________________________________________________________________
1070. OVER-THE-COUNTER (OTC) DRUG REVIEW--OVERINDULGENCE IN FOOD AND
DRINK PRODUCTS
Priority: Routine and Frequent
Legal Authority: 21 USC 321p; 21 USC 351 to 353; 21 USC 355; 21 USC
360; 21 USC 360a; 21 USC 371; 21 USC 371a; 21 USC 331
CFR Citation: 21 CFR 201; 21 CFR 310; 21 CFR 330 to 358
Legal Deadline: None
Abstract: The OTC drug review establishes conditions under which OTC
drugs are considered generally recognized as safe and effective and not
misbranded. After a final monograph (i.e. final rule) is issued, only
OTC drugs meeting the conditions of the monograph, or having an
approved new drug application, may be legally marketed. This action
addresses products containing bismuth subsalicylate for relief of
symptoms of upset stomach due to overindulgence resulting from food and
drink.
Timetable:
________________________________________________________________________
Action                            Date                      FR Cite
________________________________________________________________________
NPRM (Amendment)                01/05/05                      70 FR 741
Final Action                     To Be                       Determined
Regulatory Flexibility Analysis Required: Yes
Small Entities Affected: Businesses
Government Levels Affected: None
Agency Contact: Gerald M. Rachanow, Regulatory Counsel, Division of
Over-the-Counter Drug Products, Department of Health and Human
Services, Food and Drug Administration, 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
_______________________________________________________________________
1071. USE OF MATERIALS DERIVED FROM CATTLE IN MEDICAL PRODUCTS INTENDED
FOR USE IN HUMANS AND DRUGS INTENDED FOR USE IN RUMINANTS
Priority: Other Significant
Legal Authority: 21 USC 501; 21 USC 502; 21 USC 505; 21 USC 512; 21 USC
516; 21 USC 519; 21 USC 701; 21 USC 704; 21 USC 801; 42 USC 351; 42 USC
361
CFR Citation: 21 CFR 116; 21 CFR 226.60; 21 CFR 300.200; 21 CFR 500; 21
CFR 600.16; 21 CFR 895; 21 CFR 1271.465; 21 CFR 1271.470
Legal Deadline: None
Abstract: The regulation would prohibit the use of certain cattle
material in the manufacture of medical products for humans and drugs
for ruminants, and would require recordkeeping for products containing
or manufactured with cattle materials to enable monitoring and
enforcement of the prohibitions. The rule would prohibit the same
cattle material that is prohibited in the previous FDA IFR that applies
to foods and cosmetics. These include certain high risk tissues (e.g.,
brain, skull, eyes, spinal cord, trigeminal ganglia, parts of the
vertebral column, and dorsal root ganglia) from cattle 30 months and
older, tonsils and the distal ileum of cattle of any age, mechanically
separated beef, material
[[Page 64589]]
from nonambulatory disabled cattle, and material from cattle not
inspected and passed for human consumption. The prohibitions would
apply only to materials derived from animals slaughtered after the
effective dates of the rules. The prohibitions would not apply to
tallow that met a specified purity standard. The rule would provide
criteria for deviations from the requirements based on a showing of
safety or appropriate benefit to risk ratio.
Timetable:
________________________________________________________________________
Action                            Date                      FR Cite
________________________________________________________________________
NPRM                             To Be                       Determined
Regulatory Flexibility Analysis Required: No
Small Entities Affected: No
Government Levels Affected: None
Agency Contact: Eric Flamm, Senior Policy Advisor, Office of Policy,
Department of Health and Human Services, Food and Drug Administration,
Office of the Commissioner, 5600 Fishers Lane, Room 14C-17, HF-23,
Rockville, MD 20857
Phone: 301 827-0891
Fax: 301 827-4774
Email: eric.flamm@fda.hhs.gov
Related RIN: Merged with 0910-AF55
RIN: 0910-AF54
_______________________________________________________________________
1072. LABEL REQUIREMENT FOR FOOD THAT HAS BEEN REFUSED ADMISSION INTO
THE UNITED STATES
Priority: Other Significant
Legal Authority: 15 USC 1453 to 1455 ; 21 USC 321; 21 USC 343; 21 USC
352; 21 USC 355; 21 USC 360b; 21 USC 362; 21 USC 371; 21 USC 374; 21
USC 381; 42 USC 216; 42 USC 264
CFR Citation: 21 CFR 1.98
Legal Deadline: None
Abstract: The proposed rule would require owners or consignees to label
imported food that is refused entry into the United States. The label
would read, ``UNITED STATES: REFUSED ENTRY.'' The proposal would
describe the label's characteristics (such as its size) and processes
for verifying that the label has been affixed properly. We are taking
this action to prevent the introduction of unsafe food into the United
States, to facilitate the examination of imported food, and to
implement section 308 of the Public Health Security and Bioterrorism
Preparedness and Response Act of 2002 (the Bioterrorism Act) (Pub. L.
107-188).
Timetable:
________________________________________________________________________
Action                            Date                      FR Cite
________________________________________________________________________
NPRM                             To Be                       Determined
Regulatory Flexibility Analysis Required: Yes
Small Entities Affected: Businesses
Government Levels Affected: Undetermined
Agency Contact: Philip L. Chao, Senior Policy Analyst, Department of
Health and Human Services, Food and Drug Administration, Room 15-61
(HF-23), Office of Policy and Planning, 5600 Fishers Lane, Room 14C-17,
Rockville, MD 20857
Phone: 301 827-0587
Fax: 301 827-4774
Email: philip.chao@fda.hhs.gov
RIN: 0910-AF61
_______________________________________________________________________
1073. [bull] OVER-THE-COUNTER ANTIDIARRHEAL DRUG PRODUCTS
Priority: Routine and Frequent. Major status under 5 USC 801 is
undetermined.
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 products containing antidiarrheal drug products.
Timetable:
________________________________________________________________________
Action                            Date                      FR Cite
________________________________________________________________________
Proposed Rule                   10/00/06
Regulatory Flexibility Analysis Required: Yes
Small Entities Affected: Businesses
Government Levels Affected: None
Agency Contact: Walter Ellenberg, Regulatory Health Project Manager,
Center for Drug Evaluation and Research, Department of Health and Human
Services, Food and Drug Administration, CRP2 RMS214, HFD-560,
Rockville, MD 20850
Phone: 301 827-2279
Fax: 301-827-2316
Email: walter.ellenberg@fda.hhs.gov
Related RIN: Related to 0910-AC82
RIN: 0910-AF63
_______________________________________________________________________
1074. [bull] LOWFAT AND SKIM MILK AND LOWFAT AND NONFAT YOGURT PRODUCTS,
LOWFAT COTTAGE CHEESE: REV. OF STAND. OF IDENT.; FOOD LAB., NUTRIENT
CONT. CLAIMS FOR FAT, FATTY ACIDS, AND CHOLESTEROL CONT. OF FOODS
(SECTION 610 REVIEW)
Priority: Other Significant. Major status under 5 USC 801 is
undetermined.
Legal Authority: 21 USC 321; 21 USC 341; 21 USC 343; 21 USC 348; 21 USC
371; 21 USC 379
CFR Citation: 21 CFR 101; 21 CFR 131; 21 CFR 133
Legal Deadline: None
Abstract: Part 131 (21 CFR Part 131) describes regulations for
standards of identity for milk and milk products. Part 133 (21 CFR Part
133) describes regulations for standards of identity for cheese and
cheese products. The 1996 final rule (61 FR 58991) removed standards of
identity for sweetened condensed skim milk, lowfat dry milk, evaporated
skim milk, lowfat milk, acidified lowfat milk, skim (nonfat) milk,
cultured skim (nonfat) milk, sour half-and-half, acidified sour half-
and-half, and lowfat cottage cheese. The final rule amended the
standard of identity for dry cream by removing the reference to the
lowfat milk standard. The regulation also amended the nutrient content
claims regulations for fat, fatty acids, and cholesterol (part 101.62)
to provide for ``skim'' as a synonym for ``nonfat'' when used in
labeling milk products. The purpose of this review is to determine
whether the regulations in parts 131 and 133 should be continued
without change, or whether they should be further amended or rescinded,
consistent with the stated objectives of applicable statutes, to
minimize adverse impacts on a substantial number of small entities. FDA
will consider, and is
[[Page 64590]]
soliciting comments on, the following: (1) The continued need for the
regulations in parts 131 and 133; (2) the nature of complaints or
comments received concerning the regulations in parts 131 and 133; (3)
the complexity of the regulations in parts 131 and 133; (4) the extent
to which the regulations in parts 131 and 133 overlap, duplicate, or
conflict with other Federal, State, or governmental rules; and (5) the
degree to which technology, economic conditions, or other factors have
changed for the products still subject to the food standard regulations
in parts 131 and 133.
The section 610 review will be carried out along with a regulatory
review under section 5 of Executive Order 12866, which calls for
agencies to periodically review existing regulations to determine
whether any should be modified or eliminated so as to make the agency's
regulatory program more effective in achieving its goals, less
burdensome, or in greater alignment with the President's priorities and
the principles set forth in the Executive order. The combined effect of
the two reviews will be to determine if it is possible to redesign milk
and cheese food standards of identity in ways that will maintain or
increase the effectiveness of food labeling in providing useful
information to consumers, and, at the same time, reduce compliance and
other costs associated with the regulations.
Timetable:
________________________________________________________________________
Action                            Date                      FR Cite
________________________________________________________________________
Begin Review                    08/01/05
End Review                      12/00/06
Regulatory Flexibility Analysis Required: No
Government Levels Affected: Undetermined
Federalism:  Undetermined
Agency Contact: Richard A. Williams, Director, Division of Market
Studies, OSAS, CFSAN, Department of Health and Human Services, Food and
Drug Administration, HFS-725, Center for Food Safety and Applied
Nutrition, 5100 Paint Branch Parkway, College Park, MD 20740
Phone: 301 436-1989
Fax: 301 436-2626
Email: richard.williams@cfsan.fda.gov
RIN: 0910-AF64
_______________________________________________________________________
1075. [bull] OVER-THE-COUNTER (OTC) DRUG REVIEW--URINARY ANALGESIC DRUG
PRODUCTS
Priority: Routine and Frequent. Major status under 5 USC 801 is
undetermined.
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 the ingredient phenazopyridine.
Timetable:
________________________________________________________________________
Action                            Date                      FR Cite
________________________________________________________________________
NPRM (Urinary Analgesic)        12/00/06
Regulatory Flexibility Analysis Required: Yes
Small Entities Affected: Businesses
Government Levels Affected: None
Agency Contact: Walter Ellenberg, Regulatory Health Project Manager,
Center for Drug Evaluation and Research, Department of Health and Human
Services, Food and Drug Administration, CRP2 RMS214, HFD-560,
Rockville, MD 20850
Phone: 301 827-2279
Fax: 301-827-2316
Email: walter.ellenberg@fda.hhs.gov
RIN: 0910-AF70
_______________________________________________________________________
Department of Health and Human Services (HHS)         Completed Actions
Food and Drug Administration (FDA)
_______________________________________________________________________
1076. REQUIREMENTS PERTAINING TO SAMPLING SERVICES AND PRIVATE
LABORATORIES USED IN CONNECTION WITH IMPORTED FOOD
Priority: Routine and Frequent
CFR Citation: 21 CFR 59
Completed:
________________________________________________________________________
Reason                            Date                      FR Cite
________________________________________________________________________
Withdrawn                       08/05/05
Regulatory Flexibility Analysis Required: Yes
Small Entities Affected: Businesses
Government Levels Affected: None
Agency Contact: Philip L. Chao
Phone: 301 827-0587
Fax: 301 827-4774
Email: philip.chao@fda.hhs.gov
RIN: 0910-AB96
_______________________________________________________________________
1077. AMENDMENTS TO THE PERFORMANCE STANDARD FOR DIAGNOSTIC X-RAY
SYSTEMS AND THEIR MAJOR COMPONENTS
Priority: Economically Significant. Major under 5 USC 801.
CFR Citation: 21 CFR 1020.30; 21 CFR 1020.31; 21 CFR 1020.32; 21 CFR
1020.33
Completed:
________________________________________________________________________
Reason                            Date                      FR Cite
________________________________________________________________________
Final Action                    06/10/05                    70 FR 33998
Regulatory Flexibility Analysis Required: Yes
Small Entities Affected: Businesses
Government Levels Affected: None
Agency Contact: Myrna Hanna
Phone: 301 827-2971
Fax: 301 594-4765
Email: myh@fda.hhs.gov
RIN: 0910-AC34
_______________________________________________________________________
1078. REGISTRATION OF FOOD AND ANIMAL FEED FACILITIES
Priority: Other Significant
CFR Citation: 21 CFR 1; 21 CFR 20
Completed:
________________________________________________________________________
Reason                            Date                      FR Cite
________________________________________________________________________
Final Rule                      10/03/05                    70 FR 57505
Regulatory Flexibility Analysis Required: No
[[Page 64591]]
Small Entities Affected: Businesses
Government Levels Affected: None
Agency Contact: Catherine Copp
Phone: 301 436-1589
Fax: 301 436-2637
Email: catherine.copp@cfsan.fda.gov
RIN: 0910-AC40
_______________________________________________________________________
1079. QUALITY STANDARD REGULATION ESTABLISHING AN ALLOWABLE LEVEL FOR
ARSENIC IN BOTTLED WATER
Priority: Other Significant
CFR Citation: 21 CFR 165.110(b)
Completed:
________________________________________________________________________
Reason                            Date                      FR Cite
________________________________________________________________________
Final Rule                      06/09/05                    70 FR 33694
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: Henry Kim
Phone: 301 436-2023
Fax: 301 436-2651
Email: hkim@cfsan.fda.gov
RIN: 0910-AF10
_______________________________________________________________________
Department of Health and Human Services (HHS)       Proposed Rule Stage
Health Resources and Services Administration (HRSA)
_______________________________________________________________________
1080. 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                     12/00/05
Regulatory Flexibility Analysis Required: No
Government Levels Affected: None
Agency Contact: Andy Jordan, Chief, Shortage Designation Branch,
Department of Health and Human Services, Health Resources and Services
Administration, 5600 Fishers Lane, Room 8C-26, Rockville, MD 20857
Phone: 301 594-0197
Email: dsd@hrsa.gov
RIN: 0906-AA44
_______________________________________________________________________
1081. 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                            10/00/05
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, 5600 Fishers Lane, Room 8-103, Rockville, MD
20857
Phone: 301 443-2300
RIN: 0906-AA57
_______________________________________________________________________
1082. 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
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
[[Page 64592]]
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                            10/00/05
Regulatory Flexibility Analysis Required: No
Small Entities Affected: No
Government Levels Affected: None
Agency Contact: Dr. Laura St. Martin, Chief Medical Officer, Department
of Health and Human Services, Health Resources and Services
Administration, 5600 Fishers Lane, Room 12C-04, Parklawn Bldg.,
Rockville, MD 20857
Phone: 301 443-4423
Email: lstmartin@hrsa.gov
RIN: 0906-AA62
_______________________________________________________________________
1083. NATIONAL VACCINE INJURY COMPENSATION PROGRAM: CALCULATION OF
AVERAGE COST OF A HEALTH INSURANCE POLICY
Priority: Info./Admin./Other
Legal Authority: Section 2115 of the Public Health Service Act, 42 USC,
300aa-15
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, 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. 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 for lost earnings for a person who has
sustained a vaccine-related injury at age 18 and beyond. The injured
person would be eligible to receive compensation for loss of earnings,
after the age of 18, which are calculated on the basis of the average
gross weekly earnings of workers in the private, non-farm sector, less
appropriate taxes and the ``average cost of a health insurance policy,
as determined by the Secretary.'' The wage data are taken from the
Employment and Earnings survey done by the Department of Labor, Bureau
of Labor Statistics.
Subsection (a)(3)(A) specifically provides for payment of actual and
anticipated lost earnings for individuals injured after reaching age 18
and does not include deductions for taxes and the cost of health
insurance. This new methodology is expected to result in a more
accurate reflection of the actual average cost of a health insurance
policy as compared to the figure reached under the methodology that is
currently used which results in a number that is too high. Because the
amount of compensation for lost wages is reduced by this figure for
some petitioners receiving compensation under the VICP, such
petitioners are likely to receive a greater amount of compensation if
the amendment is adopted.
Timetable:
________________________________________________________________________
Action                            Date                      FR Cite
________________________________________________________________________
NPRM                            10/00/05
Regulatory Flexibility Analysis Required: No
Small Entities Affected: No
Government Levels Affected: None
Agency Contact: Dr. Geoffrey S. Evans, Acting Director, Division of
Vaccine Injury Compensation, Department of Health and Human Services,
Health Resources and Services Administration, Room 11C-26, 5600 Fishers
Lane, Rockville, MD 20857
Phone: 301 443-6593
Fax: 301 443-8196
Email: gevansr@hrsa.gov
RIN: 0906-AA68
_______________________________________________________________________
1084. 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                            12/00/05
[[Page 64593]]
Regulatory Flexibility Analysis Required: No
Small Entities Affected: No
Government Levels Affected: None
Agency Contact: Jose Belardo, Director, Healthy Tomorrow's Partnership
for Children Program, Department of Health and Human Services, Health
Resources and Services Administration, 5600 Fishers Lane, Room 18A-55,
Rockville, MD 20857
Phone: 301 443-0757
Email: jbelardo@hrsa.gov
RIN: 0906-AA70
_______________________________________________________________________
Department of Health and Human Services (HHS)          Final Rule Stage
Health Resources and Services Administration (HRSA)
_______________________________________________________________________
1085. 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                    10/00/05
Regulatory Flexibility Analysis Required: No
Small Entities Affected: No
Government Levels Affected: None
Agency Contact: Mr. Paul T. Clark, Director, Smallpox Vaccine Injury
Compensation Program, Department of Health and Human Services, Health
Resources and Services Administration, 11th Floor, 5600 Fishers Lane,
Rockville, MD 20857
Phone: 301 443-5255
Email: smallpox@hrsa.gov
Related RIN: Related to 0906-AA61
RIN: 0906-AA60
_______________________________________________________________________
1086. SMALLPOX VACCINE INJURY COMPENSATION PROGRAM: ADMINISTRATIVE
IMPLEMENTATION
Priority: Other Significant. Major status under 5 USC 801 is
undetermined.
Legal Authority: PL 108-20, 117 Stat 638
CFR Citation: 42 CFR 102
Legal Deadline: None
Abstract: To provide benefits to certain persons harmed as a result of
receiving smallpox covered countermeasures, including the smallpox
vaccine, or as a result of contracting vaccinia through accidental
exposure to certain persons. The Secretary may also provide death
benefits to certain survivors of people who died as a direct result of
these injuries.
Timetable:
________________________________________________________________________
Action                            Date                      FR Cite
________________________________________________________________________
Interim Final Rule              12/16/03                    68 FR 70080
Final Action                    10/00/05
Regulatory Flexibility Analysis Required: No
Small Entities Affected: No
Government Levels Affected: None
Agency Contact: Mr. Paul T. Clark, Director, Smallpox Vaccine Injury
Compensation Program, Department of Health and Human Services, Health
Resources and Services Administration, 11th Floor, 5600 Fishers Lane,
Rockville, MD 20857
Phone: 301 443-5255
Email: smallpox@hrsa.gov
Related RIN: Related to 0906-AA60
RIN: 0906-AA61
_______________________________________________________________________
1087. 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                    12/00/05
Regulatory Flexibility Analysis Required: No
Small Entities Affected: No
Government Levels Affected: None
Agency Contact: Jose Rafael Morales, Acting Director, Division of
Community Based Programs, Department of Health and Human Services,
Health Resources and Services Administration, 5600 Fishers Lane, Room
7A-21, Rockville, MD 20857
Phone: 301 443-3650
[[Page 64594]]
Email: jmorales@hrsa.gov
RIN: 0906-AA65
_______________________________________________________________________
1088. 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                            06/07/05                    70 FR 33053
NPRM Comment Period End         08/08/05
Final Rule                      06/00/06
Regulatory Flexibility Analysis Required: No
Government Levels Affected: Undetermined
Agency Contact: Gail Ellen Lipton, Director, Division of Grants Policy,
Department of Health and Human Services, Health Resources and Services
Administration, Room 11A-55, 5600 Fishers Lane, Rockville, MD 20857
Phone: 301 443-6509
Email: glipton@hrsa.gov
RIN: 0906-AA69
_______________________________________________________________________
Department of Health and Human Services (HHS)         Long-Term Actions
Health Resources and Services Administration (HRSA)
_______________________________________________________________________
1089. NATIONAL PRACTITIONER DATA BANK FOR ADVERSE INFORMATION ON
PHYSICIANS AND OTHER HEALTH CARE PRACTITIONERS: MEDICAL MALPRACTICE
PAYMENTS REPORTING REQUIREMENTS
Priority: Substantive, Nonsignificant
Legal Authority: 42 USC 11131
CFR Citation: 45 CFR 60.7
Legal Deadline: None
Abstract: This notice of proposed rulemaking (NPRM) proposes to require
that, in addition to reporting to the National Practitioner Data Bank
medical malpractice payments made where physicians or other health care
practitioners are named in medical malpractice actions or claims,
judgments, or settlements, payments be reported where they are made for
the benefit of physicians or other health care practitioners not named
in the judgments or settlements but who furnished or failed to furnish
the health care services upon which the actions or claims were based.
The purpose of this NPRM is to prevent the evasion of the medical
malpractice payment reporting requirement of the Data Bank through the
agreement of the parties to a lawsuit to use the corporate health care
entity to ``shield'' practitioners. It would also require malpractice
payers, in very limited circumstances, when it is impossible to
identify the practitioner who furnished or failed to furnish the health
care services upon which the actions or claims were based, to report
why the practitioner could not be identified, and to provide the name
of the corporate health care entity.
Timetable:
________________________________________________________________________
Action                            Date                      FR Cite
________________________________________________________________________
NPRM                            12/24/98                    63 FR 71255
Second NPRM                      To Be                       Determined
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, 5600 Fishers Lane, Room 8-103, Rockville, MD
20857
Phone: 301 443-2300
RIN: 0906-AA41
_______________________________________________________________________
1090. 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
[[Page 64595]]
_______________________________________________________________________
Department of Health and Human Services (HHS)       Proposed Rule Stage
Indian Health Service (IHS)
_______________________________________________________________________
1091. SECTION 506--LIMITATION ON CHARGES FOR SERVICES FURNISHED BY
MEDICARE PARTICIPATING INPATIENT HOSPITAL TO INDIANS
Priority: Substantive, Nonsignificant. Major status under 5 USC 801 is
undetermined.
Legal Authority: MMA, sec 506; PL 108-173
CFR Citation: 42 CFR 135, subpart D; 42 CFR 489, subpart B
Legal Deadline: None
Abstract: This provision requires that as a condition of participation
in the Medicare Program, providers accept payment at rates established
by the Secretary in regulations as payment in full for services
provided in an inpatient hospital to American Indians/Alaskan Natives
(AI/AN) beneficiaries referred or authorized by the Indian Health
Service, Tribes or Tribal organizations, or Urban Indian Organization
(I/T/U).
Timetable:
________________________________________________________________________
Action                            Date                      FR Cite
________________________________________________________________________
NPRM                            12/00/05
NPRM Comment Period End         02/00/06
Final Action                    12/00/06
Regulatory Flexibility Analysis Required: No
Government Levels Affected: None
Agency Contact: Betty Z. Gould, Regulations Officer, Department of
Health and Human Services, Indian Health Service, 12300 Twinbrook
Parkway, Suite 450, Rockville, MD 20852
Phone: 301 443-1116
Email: bgould@hqe.ihs.gov
RIN: 0917-AA07
_______________________________________________________________________
Department of Health and Human Services (HHS)       Proposed Rule Stage
National Institutes of Health (NIH)
_______________________________________________________________________
1092. [bull] GRANTS FOR RESEARCH PROJECTS -- 42 CFR PART 52-NPRM
Priority: Substantive, Nonsignificant
Legal Authority: 42 USC 216
CFR Citation: 42 CFR 52
Legal Deadline: None
Abstract: NIH proposes to amend the regulations governing grants for
research projects by revising the definition of Principal Investigator
to mean one or more individuals designated by the grantee in the grant
application and approved by the Secretary, who is or are responsible
for the scientific and technical direction of the project, rather than
limiting the role of principal investigator to one single individual
when that more accurately reflects the management needs of a research
project.
Timetable:
________________________________________________________________________
Action                            Date                      FR Cite
________________________________________________________________________
NPRM                            01/00/06
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-AA42
_______________________________________________________________________
1093. [bull] NATIONAL INSTITUTES OF HEALTH LOAN REPAYMENT PROGRAMS
Priority: Substantive, Nonsignificant
Legal Authority: 42 USC 216 42 USC 288-5a; 42 USC 287c-33 USC 288-6; 42
USC 288-1 42 USC 288-3 42 USC 288-5; 42 USC 288-5a 42 USC 288-6
CFR Citation: 42 CFR 68
Legal Deadline: None
Abstract: NIH proposes to issue a single set of regulations to govern
all of its loan repayment (LPR) authorities. This action will include
rescinding the current regulations at 42 CFR 68a and at 42 CFR 68c in
lieu of the new consolidated set of LRP regulations. This action will
also include withdrawing the previously announced planned actions
concerning NIH LRP authorities.
Timetable:
________________________________________________________________________
Action                            Date                      FR Cite
________________________________________________________________________
NPRM                            04/00/06
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-AA43
_______________________________________________________________________
1094. [bull] NATIONAL LIBRARY OF MEDICINE TRAINING GRANTS
Priority: Substantive, Nonsignificant
Legal Authority: 42 USC 216 42 USC 286b-3
CFR Citation: 42 CFR 64
Legal Deadline: None
Abstract: NIH proposes to amend the regulations governing National
Library of Medicine training grants by revising the definition of
Project Director to mean one or more individuals designated by the
grantee in the grant application and approved by the Secretary, who is
or are responsible for the scientific and technical direction of the
project, rather than limiting the role of the project director to one
single individual when that more accurately reflects the management
needs of a research project.
Timetable:
________________________________________________________________________
Action                            Date                      FR Cite
________________________________________________________________________
NPRM                            04/00/06
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
[[Page 64596]]
Phone: 301 496-4606
Fax: 301 402-0169
Email: jm40z@nih.gov
RIN: 0925-AA44
_______________________________________________________________________
1095. [bull] MINORITY BIOMEDICAL RESEARCH SUPPORT PROGRAM
Priority: Substantive, Nonsignificant. Major status under 5 USC 801 is
undetermined.
Legal Authority: 42 USC 216 42 USC 241(a) (3)
CFR Citation: 42 CFR 52c
Legal Deadline: None
Abstract: NIH proposes to amend the regulations governing Minority
Biomedical Research Support Program grants by revising the definition
of Program Director to mean one or more individuals designated by the
grant application and approved by the Secretary, who is or are
responsible for the scientific and technical direction of the program,
rather than limiting the role of the program director to one single
individual when that more accurately reflects the management needs of a
research program.
Timetable:
________________________________________________________________________
Action                            Date                      FR Cite
________________________________________________________________________
NPRM                            04/00/06
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-AA45
_______________________________________________________________________
1096. [bull] NATIONAL INSTITUTE OF ENVIRONMENTAL HEALTH SCIENCES
HAZARDOUS SUBSTANCES BASIC RESEARCH AND TRAINING GRANTS
Priority: Substantive, Nonsignificant
Legal Authority: 42 USC 216; 42 USC 286b-3
CFR Citation: 42 CFR 65a
Legal Deadline: None
Abstract: NIH proposes to amend the regulations governing National
Institute of Environmental Health Sciences Hazardous Substances Basic
Research and Training grants by revising the definition of Program
Director to mean one or more individuals designated by the grantee in
the grant application and approved by the Secretary, who is or are
responsible for the scientific and technical direction of the project,
rather than limiting the role of the program director to one single
individual when that more accurately reflects the management needs of a
research project.
Timetable:
________________________________________________________________________
Action                            Date                      FR Cite
________________________________________________________________________
NPRM                            04/00/06
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-AA46
_______________________________________________________________________
Department of Health and Human Services (HHS)          Final Rule Stage
National Institutes of Health (NIH)
_______________________________________________________________________
1097. 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 Health Act of 2000. Section 1002 of this Act adds a new
section 452G to the PHS Act that authorizes the Director of the
National Institute of Child Health and Human Development, in
consultation with the Administrator of the Health Resources and
Services Administration, to support activities to provide for an
increase in the number and size of institutional training grants
supporting pediatric training.
Timetable:
________________________________________________________________________
Action                            Date                      FR Cite
________________________________________________________________________
NPRM                            01/28/05                     70 FR 4080
Final Action                    01/00/06
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
_______________________________________________________________________
1098. STANDARDS FOR A NATIONAL CHIMPANZEE SANCTUARY SYSTEM
Priority: Other Significant
Legal Authority: 42 USC 287a-3a
CFR Citation: 42 CFR 9
Legal Deadline: NPRM, Statutory, June 18, 2001.
Abstract: NIH proposes to establish standards for operating a national
chimpanzee sanctuary system to provide for the retirement of federally-
owned or supported chimpanzees no longer needed for research.
Timetable:
________________________________________________________________________
Action                            Date                      FR Cite
________________________________________________________________________
NPRM                            01/11/05                     70 FR 1843
Final Action                    01/00/06
Regulatory Flexibility Analysis Required: No
Small Entities Affected: No
[[Page 64597]]
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
_______________________________________________________________________
Department of Health and Human Services (HHS)         Completed Actions
National Institutes of Health (NIH)
_______________________________________________________________________
1099. UNDERGRADUATE SCHOLARSHIP PROGRAM REGARDING PROFESSIONS NEEDED BY
THE NATIONAL INSTITUTES OF HEALTH (NIH)
Priority: Substantive, Nonsignificant
CFR Citation: 42 CFR 68b
Completed:
________________________________________________________________________
Reason                            Date                      FR Cite
________________________________________________________________________
Withdrawn                       10/20/05
Regulatory Flexibility Analysis Required: No
Government Levels Affected: None
Agency Contact: Jerry Moore
Phone: 301 496-4606
Fax: 301 402-0169
Email: jm40z@nih.gov
RIN: 0925-AA10
_______________________________________________________________________
1100. NATIONAL INSTITUTES OF HEALTH LOAN REPAYMENT PROGRAM FOR RESEARCH
GENERALLY
Priority: Substantive, Nonsignificant
CFR Citation: 42 CFR 68d
Completed:
________________________________________________________________________
Reason                            Date                      FR Cite
________________________________________________________________________
Withdrawn                       08/05/05
Regulatory Flexibility Analysis Required: No
Government Levels Affected: None
Agency Contact: Jerry Moore
Phone: 301 496-4606
Fax: 301 402-0169
Email: jm40z@nih.gov
Jerry Moore
Phone: 301 496-4606
Fax: 301 402-0169
Email: jm40z@nih.gov
RIN: 0925-AA18
_______________________________________________________________________
1101. NATIONAL INSTITUTES OF HEALTH AIDS RESEARCH LOAN REPAYMENT PROGRAM
Priority: Substantive, Nonsignificant
CFR Citation: 42 CFR 68
Completed:
________________________________________________________________________
Reason                            Date                      FR Cite
________________________________________________________________________
Withdrawn                       08/05/05
Regulatory Flexibility Analysis Required: No
Small Entities Affected: No
Government Levels Affected: None
Agency Contact: Jerry Moore
Phone: 301 496-4606
Fax: 301 402-0169
Email: jm40z@nih.gov
RIN: 0925-AA32
_______________________________________________________________________
1102. NATIONAL INSTITUTES OF HEALTH EXTRAMURAL LOAN REPAYMENT PROGRAM
FOR CLINICAL RESEARCHERS
Priority: Substantive, Nonsignificant
CFR Citation: 42 CFR 68g
Completed:
________________________________________________________________________
Reason                            Date                      FR Cite
________________________________________________________________________
Withdrawn                       10/20/05
Regulatory Flexibility Analysis Required: No
Small Entities Affected: No
Government Levels Affected: None
Agency Contact: Jerry Moore
Phone: 301 496-4606
Fax: 301 402-0169
Email: jm40z@nih.gov
RIN: 0925-AA33
_______________________________________________________________________
1103. NATIONAL INSTITUTES OF HEALTH PEDIATRIC RESEARCH LOAN REPAYMENT
PROGRAM
Priority: Substantive, Nonsignificant
CFR Citation: 42 CFR 68e
Completed:
________________________________________________________________________
Reason                            Date                      FR Cite
________________________________________________________________________
Withdrawn                       10/20/05
Regulatory Flexibility Analysis Required: No
Small Entities Affected: No
Government Levels Affected: None
Agency Contact: Jerry Moore
Phone: 301 496-4606
Fax: 301 402-0169
Email: jm40z@nih.gov
RIN: 0925-AA34
_______________________________________________________________________
1104. NATIONAL INSTITUTES OF HEALTH LOAN REPAYMENT PROGRAM FOR HEALTH
DISPARITIES RESEARCH
Priority: Substantive, Nonsignificant
CFR Citation: 42 CFR 68f
Completed:
________________________________________________________________________
Reason                            Date                      FR Cite
________________________________________________________________________
Withdrawn                       10/20/05
Regulatory Flexibility Analysis Required: No
Small Entities Affected: No
Government Levels Affected: None
Agency Contact: Jerry Moore
Phone: 301 496-4606
Fax: 301 402-0169
Email: jm40z@nih.gov
RIN: 0925-AA35
_______________________________________________________________________
1105. NATIONAL INSTITUTES OF HEALTH CLINICAL RESEARCH LOAN REPAYMENT
PROGRAM FOR INDIVIDUALS FROM DISADVANTAGED BACKGROUNDS
Priority: Substantive, Nonsignificant
CFR Citation: 42 CFR 68a
Completed:
________________________________________________________________________
Reason                            Date                      FR Cite
________________________________________________________________________
Withdrawn                       10/20/05
Regulatory Flexibility Analysis Required: No
Small Entities Affected: No
Government Levels Affected: None
Agency Contact: Jerry Moore
[[Page 64598]]
Phone: 301 496-4606
Fax: 301 402-0169
Email: jm40z@nih.gov
RIN: 0925-AA36
_______________________________________________________________________
1106. NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT
CONTRACEPTION AND INFERTILITY RESEARCH LOAN REPAYMENT PROGRAM
Priority: Substantive, Nonsignificant
CFR Citation: 42 CFR 68c
Completed:
________________________________________________________________________
Reason                            Date                      FR Cite
________________________________________________________________________
Withdrawn                       10/20/05
Regulatory Flexibility Analysis Required: No
Small Entities Affected: No
Government Levels Affected: None
Agency Contact: Jerry Moore
Phone: 301 496-4606
Fax: 301 402-0169
Email: jm40z@nih.gov
RIN: 0925-AA41
_______________________________________________________________________
Department of Health and Human Services (HHS)             Prerule Stage
Office of Public Health and Science (OPHS)
_______________________________________________________________________
1107. HUMAN SUBJECTS PROTECTION REGULATIONS: ADDITIONAL PROTECTIONS FOR
ADULT INDIVIDUALS WITH IMPAIRED DECISIONMAKING CAPACITY
Priority: Substantive, Nonsignificant. Major status under 5 USC 801 is
undetermined.
Legal Authority: 5 USC 301; 42 USC 289
CFR Citation: 45 CFR 46
Legal Deadline: None
Abstract: Through this advance notice of proposed rulemaking (ANPRM),
the Office for Human Research Protections (OHRP), Office of Public
Health and Science, and the Food and Drug Administration (FDA) of the
Department of Health and Human Services (HHS) are seeking comment on
whether it is necessary to develop additional safeguards to help
protect adult individuals with impaired decisionmaking capacity who are
potential subjects in research, and if so, suggestions for appropriate
safeguards. This ANPRM stems from the recommendation of an HHS working
group, generated in response to the report published by the National
Bioethics Advisory Commission entitled ``Research Involving Persons
with Mental Disorders That May Affect Decisionmaking Capacity''
(December 1998), and from subsequent recommendations by the National
Human Research Protections Advisory Committee. The goal of these
efforts is to maximize the safety and welfare of adult subjects with
impaired decisionmaking capacity who participate in research supported,
conducted, or regulated by HHS.
Timetable:
________________________________________________________________________
Action                            Date                      FR Cite
________________________________________________________________________
ANPRM                           06/00/06
ANPRM Comment Period End        09/00/06
Regulatory Flexibility Analysis Required: No
Small Entities Affected: No
Government Levels Affected: None
Agency Contact: Irene Stith-Coleman Ph.D, Department of Health and
Human Services, Office of Public Health and Science, Suite 200, The
Tower Building, 1101 Wootten Parkway, Rockville, MD 20852
Phone: 240 453-6900
Fax: 301 402-2071
RIN: 0940-AA11
_______________________________________________________________________
Department of Health and Human Services (HHS)          Final Rule Stage
Office of Public Health and Science (OPHS)
_______________________________________________________________________
1108. PUBLIC HEALTH SERVICE STANDARDS FOR THE PROTECTION OF RESEARCH
MISCONDUCT WHISTLEBLOWERS
Priority: Substantive, Nonsignificant
Legal Authority: 42 USC 216; 42 USC 241; 42 USC 289b
CFR Citation: 42 CFR 94
Legal Deadline: None
Abstract: To implement section 493(e) of the Public Health Service Act
(added by section 163 of the National Institutes of Health
Revitalization Act of 1993, Pub. L. 103-43), the Department is
proposing to add a new part 94 to title 42 of the Code of Federal
Regulations. Under this proposed regulation, covered institutions must
follow certain requirements for preventing and responding to
occurrences of retaliation against whistleblowers. The purpose of this
part is to protect: 1) Persons who make a good faith allegation that a
covered institution or member thereof engaged in, or failed to respond
adequately to an allegation of research misconduct; and 2) persons who
cooperate in good faith with an investigation of research misconduct.
Timetable:
________________________________________________________________________
Action                            Date                      FR Cite
________________________________________________________________________
NPRM                            11/28/00                    65 FR 70830
NPRM Comment Period End         01/29/01
Final Action                    08/00/06
Regulatory Flexibility Analysis Required: No
Small Entities Affected: No
Government Levels Affected: None
Agency Contact: Chris Pascal, Director, Office of Research Integrity,
Department of Health and Human Services, Office of Public Health and
Science, Suite 750, 1101 Wootten Parkway, Rockville, MD 20852
Phone: 240 453-8200
[[Page 64599]]
Fax: 301 443-5351
Related RIN: Related to 0940-AA04
RIN: 0940-AA01
_______________________________________________________________________
1109. 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                    03/00/06
Regulatory Flexibility Analysis Required: No
Small Entities Affected: No
Government Levels Affected: None
Agency Contact: Irene Stith-Coleman Ph.D, Department of Health and
Human Services, Office of Public Health and Science, Suite 200, The
Tower Building, 1101 Wootten Parkway, Rockville, MD 20852
Phone: 240 453-6900
Fax: 301 402-2071
RIN: 0940-AA06
_______________________________________________________________________
1110. 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                    11/00/05
Regulatory Flexibility Analysis Required: No
Small Entities Affected: No
Government Levels Affected: None
Agency Contact: Michael A. Carome MD, Department of Health and Human
Services, Office of Public Health and Science, Suite 200, The Tower
Building, 1101 Wootten Parkway, Rockville, MD 20852
Phone: 240 453-6900
Fax: 301 402-2071
RIN: 0940-AA10
_______________________________________________________________________
Department of Health and Human Services (HHS)         Long-Term Actions
Office of Public Health and Science (OPHS)
_______________________________________________________________________
1111. HUMAN SUBJECTS PROTECTION REGULATIONS: TRAINING AND ED.
REQUIREMENTS FOR INSTITUTIONAL OFFICIALS, INSTITUTIONAL REVIEW BOARD
MEMBERS AND STAFF, HUMAN PROTECTIONS ADMINISTRATORS, AND INVESTIGATORS
Priority: Other Significant. Major status under 5 USC 801 is
undetermined.
Legal Authority: 5 USC 301; 42 USC 289
CFR Citation: 45 CFR 46
Legal Deadline: None
Abstract: This notice of proposed rulemaking proposes to add subpart E
to the Department of Health and Human Services (HHS) regulations for
protection of human subjects, 45 CFR part 46, and would require that
institutions engaged in human subjects research covered by an assurance
of compliance filed with the Office for Human Research Protections
ensure that institutional officials, institutional review board (IRB)
chairpersons, and human protection administrators receive appropriate
training and education about the institution's 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
[[Page 64600]]
Regulatory Flexibility Analysis Required: No
Small Entities Affected: No
Government Levels Affected: None
Agency Contact: Michael A. Carome MD, Department of Health and Human
Services, Office of Public Health and Science, Suite 200, The Tower
Building, 1101 Wootten Parkway, Rockville, MD 20852
Phone: 240 453-6900
Fax: 301 402-2071
RIN: 0940-AA08
_______________________________________________________________________
Department of Health and Human Services (HHS)         Completed Actions
Office of Public Health and Science (OPHS)
_______________________________________________________________________
1112. PUBLIC HEALTH SERVICE POLICIES ON RESEARCH MISCONDUCT
Priority: Other Significant
CFR Citation: 42 CFR 93
Completed:
________________________________________________________________________
Reason                            Date                      FR Cite
________________________________________________________________________
Final Action                    05/17/05                    70 FR 28370
Regulatory Flexibility Analysis Required: No
Small Entities Affected: No
Government Levels Affected: None
Agency Contact: Chris Pascal
Phone: 240 453-8200
Fax: 301 443-5351
Related RIN: Related to 0940-AA01
RIN: 0940-AA04
_______________________________________________________________________
Department of Health and Human Services (HHS)             Prerule Stage
Centers for Medicare & Medicaid Services (CMS)
_______________________________________________________________________
1113. [bull] INNOVATIONS IN FEE-FOR-SERVICE PAYMENT SYSTEMS TO IMPROVE
QUALITY AND OUTCOMES (CMS-1298-ANPR)
 Regulatory Plan: This entry is Seq. No. 50 in part II of this issue of
the Federal Register.
RIN: 0938-AN91
_______________________________________________________________________
Department of Health and Human Services (HHS)       Proposed Rule Stage
Centers for Medicare & Medicaid Services (CMS)
_______________________________________________________________________
1114. HOME HEALTH AGENCY (HHA) CONDITIONS OF PARTICIPATION (COPS) (CMS-
3819-P) (SECTION 610 REVIEW)
Priority: Other Significant
Legal Authority: 42 USC 1302; 42 USC 1395x; 42 USC 1395cc(a); 42 USC
1395hh; 42 USC 1395bb
CFR Citation: 42 CFR 484
Legal Deadline: None
Abstract: This proposed rule would revise the existing Conditions of
Participation (CoPs) that Home Health Agencies (HHAs) must meet to
participate in the Medicare program. The requirements focus on the
actual care delivered to patients by HHAs, reflect an interdisciplinary
view of patient care, allow HHAs greater flexibility in meeting quality
standards, and eliminate unnecessary procedural requirements. These
changes are an integral part of the Administration's efforts to achieve
broad-based improvements and measurements of the quality of care
furnished through Federal programs while at the same time reducing
procedural burdens on providers.
Timetable:
________________________________________________________________________
Action                            Date                      FR Cite
________________________________________________________________________
NPRM                            03/10/97                    62 FR 11005
NPRM Comment Period End         06/09/97
Second NPRM                     06/00/06
Regulatory Flexibility Analysis Required: No
Small Entities Affected: Businesses, Organizations
Government Levels Affected: None
Agency Contact: Scott Cooper, Health Insurance Specialist, Department
of Health and Human Services, Centers for Medicare & Medicaid Services,
Clinical Standards Group, Mailstop S3-05-15, 7500 Security Boulevard,
Baltimore, MD 21244
Phone: 410 786-9465
Email: scott.cooper@cms.hhs.gov
Mercedes Benitez-McCray, Health Insurance Specialist, Department of
Health and Human Services, Centers for Medicare & Medicaid Services,
Clinical Standards Group, Mailstop S3-05-14, 7500 Security Boulevard,
Baltimore, MD 21244
Phone: 410 786-5716
Email: mercedes.benitezmccra@cms.hhs.gov
RIN: 0938-AG81
_______________________________________________________________________
1115. STANDARD UNIQUE NATIONAL HEALTH PLAN IDENTIFIER (CMS-6017-P)
Priority: Other Significant. Major under 5 USC 801.
Unfunded Mandates: This action may affect State, local or tribal
governments.
Legal Authority: 42 USC 1320d to 1320d-8
[[Page 64601]]
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                            06/00/06
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, Office of Financial
Management, Mailstop C3-02-16, 7500 Security Boulevard, Baltimore, MD
21244
Phone: 410 786-7448
RIN: 0938-AH87
_______________________________________________________________________
1116. APPEALS OF CARRIER DETERMINATIONS THAT A SUPPLIER FAILS TO MEET
THE REQUIREMENTS FOR MEDICARE BILLING PRIVILEGES (CMS-6003-P2)
Priority: Substantive, Nonsignificant
Legal Authority: 42 USC 1302; 42 USC 1395u(b)(3)(C); 42 USC 1395ff(b)
CFR Citation: 42 CFR 405.874
Legal Deadline: None
Abstract: This proposed rule would extend appeal rights to all
suppliers whose enrollment applications for Medicare billing privileges
are disallowed by a carrier or whose Medicare billing privileges are
revoked, except for those suppliers covered under other existing
appeals provisions of our regulations. In addition, certain appeal
provisions are revised to correspond with the existing appeal
provisions in those other sections of our regulations. The rule would
also extend appeal rights to all suppliers not covered by existing
regulations to ensure they have a full and fair opportunity to be
heard. This rule would incorporate provisions from section 936 of the
Medicare Modernization Act.
Timetable:
________________________________________________________________________
Action                            Date                      FR Cite
________________________________________________________________________
NPRM                            10/25/99                    64 FR 57431
Second NPRM                     02/00/06
Regulatory Flexibility Analysis Required: No
Small Entities Affected: Businesses
Government Levels Affected: None
Agency Contact: Michael Collett, Health Insurance Specialist,
Department of Health and Human Services, Centers for Medicare &
Medicaid Services, Mailstop C3-02-16, 7500 Security Boulevard,
Baltimore, MD 21244-1850
Phone: 410 786-6121
Email: michael.collett@cms.hhs.gov
RIN: 0938-AI49
_______________________________________________________________________
1117. 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 proposes to amend the Medicare certification and
payment requirements for rural health clinics (RHCs), as required by
Section 4205 of the Balanced Budget Act of 1997. It proposes to change
the definition of a qualifying rural shortage area in which a Medicare
RHC must be located; establish 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 limit nonphysician practitioner staffing requirements. This rule
proposes to impose payment limits on provider-based RHCs and prohibit
the use of RHC space, professional staff, equipment, and other RHC
resources by another Medicare entity. The rule also proposes to require
RHCs to establish a quality assessment and performance improvement
program.
Timetable:
________________________________________________________________________
Action                            Date                      FR Cite
________________________________________________________________________
NPRM                            12/24/03                    68 FR 74792
Second NPRM                     04/00/06
Regulatory Flexibility Analysis Required: No
Small Entities Affected: Businesses
Government Levels Affected: Federal
Agency Contact: David Worgo, Health Insurance Specialist, Ambulatory
Policy Group, Department of Health and Human Services, Centers for
Medicare & Medicaid Services, Hospital and Ambulatory, Mailstop C4-15-
18, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-5919
Email: david.worgo@cms.hhs.gov
RIN: 0938-AJ17
_______________________________________________________________________
1118. USE OF RESTRAINTS AND SECLUSION IN MEDICARE AND MEDICAID
PARTICIPATING FACILITIES THAT PROVIDE INPATIENT OR RESIDENTIAL CARE
(CMS-2130-P)
Priority: Other Significant. Major status under 5 USC 801 is
undetermined.
Legal Authority: PL 106-554, (BIPA 2000 of the Children's Health Act)
CFR Citation: 42 CFR 101; 42 CFR 418; 42 CFR 482; 42 CFR 483; 42 CFR
485
Legal Deadline: None
Abstract: This proposed rule would implement provisions of the
Children's Health Act of 2000 (CHA) related to the use of restraints or
seclusion for individuals receiving services in health care facilities
that receive Federal funding. The rule would establish common
terminology and basic expectations for the use of restraints and
seclusion for health care facilities that furnish inpatient or
residential care and receive Medicare or Medicaid funding.
Timetable:
________________________________________________________________________
Action                            Date                      FR Cite
________________________________________________________________________
NPRM                            04/00/06
Regulatory Flexibility Analysis Required: Undetermined
Small Entities Affected:  Businesses
Government Levels Affected: Undetermined
Federalism:  Undetermined
Agency Contact: Carla McGregor, Health Insurance Specialist, Survey and
[[Page 64602]]
Certification Group, Department of Health and Human Services, Centers
for Medicare & Medicaid Services, Mailstop S2-11-27, 7500 Security
Boulevard, Baltimore, MD 21244-1850
Phone: 410 786-0663
Email: carla.mcgregor@cms.hhs.gov
RIN: 0938-AL26
_______________________________________________________________________
1119. 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                            06/00/06
Regulatory Flexibility Analysis Required: No
Small Entities Affected: Businesses
Government Levels Affected: State
Agency Contact: Joan Brooks, Health Insurance Specialist, Department of
Health and Human Services, Centers for Medicare & Medicaid Services,
Clinical Standards Group, Mailstop S3-02-01, 7500 Security Boulevard,
Baltimore, MD 21244
Phone: 410 786-5526
Email: joan.brooks@cms.hhs.gov
Jacqueline Morgan, Health Insurance Specialist, Department of Health
and Human Services, Centers for Medicare & Medicaid Services, Clinical
Standards and Group, Mailstop S3-02-01, 7500 Security Boulevard,
Baltimore, MD 21244
Phone: 410 786-4282
Email: jmorgan@cms.hhs.gov
RIN: 0938-AL80
_______________________________________________________________________
1120. 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 some of the electronic
transactions and code set standards mandated by the Health Insurance
Portability and Accountability Act of 1966.
Timetable:
________________________________________________________________________
Action                            Date                      FR Cite
________________________________________________________________________
NPRM                            05/00/06
Regulatory Flexibility Analysis Required: Undetermined
Small Entities Affected:  Businesses, Governmental Jurisdictions,
Organizations
Government Levels Affected: Federal, Local, State, Tribal
Federalism:  This action may have federalism implications as defined in
EO 13132.
Agency Contact: Gladys C. Wheeler, Health Insurance Specialist,
Department of Health and Human Services, Centers for Medicare &
Medicaid Services, Office of E-Health Standards and Services, Mail Stop
S2-24-18, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-0273
Email: gladys.wheeler@cms.hhs.gov
RIN: 0938-AM50
_______________________________________________________________________
1121. 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 establishes requirements that hospice
agencies and long term care (LTC) facilities must meet to participate
in the Medicare and Medicaid programs. We are proposing these new
requirements to ensure that quality hospice care is provided to
eligible residents.
Timetable:
________________________________________________________________________
Action                            Date                      FR Cite
________________________________________________________________________
NPRM                            05/00/06
Regulatory Flexibility Analysis Required: Yes
Small Entities Affected: Businesses
Government Levels Affected: None
Agency Contact: Anita Panicker, Health Insurance Specialist, Department
of Health and Human Services, Centers for Medicare & Medicaid Services,
Clinical Standards Group, Mailstop S3-02-01, 7500 Security Boulevard,
Baltimore, MD 21244
Phone: 410 786-5646
Fax: 410 786-8532
Email: anita.panicker@cms.hhs.gov
RIN: 0938-AM87
_______________________________________________________________________
1122. COMPETITIVE ACQUISITION FOR CERTAIN DURABLE MEDICAL EQUIPMENT
(DME), PROSTHETICS, ORTHOTICS, AND SUPPLIES AND RESIDUAL ISSUES (CMS-
1270-P)
 Regulatory Plan: This entry is Seq. No. 51 in part II of this issue of
the Federal Register.
RIN: 0938-AN14
_______________________________________________________________________
1123. REVISIONS TO HIPAA CODE SETS (CMS-0013-P)
Priority: Economically Significant. Major under 5 USC 801.
Unfunded Mandates: Undetermined
Legal Authority: PL 104-191
CFR Citation: 45 CFR 162
Legal Deadline: None
Abstract: This proposed rule would revise some of the adopted
transaction and code set standards detailed in regulations published by
HHS on August 17, 2000, and February 20, 2003.
Timetable:
________________________________________________________________________
Action                            Date                      FR Cite
________________________________________________________________________
NPRM                            09/00/06
Regulatory Flexibility Analysis Required: Yes
[[Page 64603]]
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: Gladys Wheeler, Health Insurance Specialist, Office of
E-Health Standards and Services, Department of Health and Human
Services, Centers for Medicare & Medicaid Services, Mailstop S2-26-17,
7500 Security Boulevard, Baltimore, MD 21244-1850
Phone: 410 786-0273
Email: gladys.wheeler@cms.hhs.gov
RIN: 0938-AN25
_______________________________________________________________________
1124. 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: Final, Statutory, July 1, 2004.
Abstract: The Medicare Modernization Act of 2003 (MMA), requires
codification of the payment basis for determining Medicare payments for
new clinical laboratory tests under the clinical laboratory fee
schedule. Also, section 416 of the MMA eliminates the application of
the clinical laboratory fee schedule for hospital outpatient laboratory
testing by a hospital with fewer than 50 beds in a qualified rural area
for cost reporting periods beginning during the two-year period
beginning on July 1, 2004. Section 1833(h) of the Social Security Act
mandates payment for outpatient clinical laboratory tests under a
clinical laboratory fee schedule.
Timetable:
________________________________________________________________________
Action                            Date                      FR Cite
________________________________________________________________________
NPRM                            05/00/06
Regulatory Flexibility Analysis Required: Yes
Small Entities Affected: Businesses
Government Levels Affected: None
Agency Contact: Anita Greenberg, Health Insurance Specialist, Center
for Medicare Management, Department of Health and Human Services,
Centers for Medicare & Medicaid Services, Mailstop C4-07-07, 7500
Security Boulevard, Baltimore, MD 21244
Phone: 410 786-4601
Email: anita.greenberg@cms.hhs.gov
RIN: 0938-AN26
_______________________________________________________________________
1125. TERMINATION OF NON-RANDOM PREPAYMENT MEDICAL REVIEW (CMS-6022-F)
Priority: Other Significant
Legal Authority: Sec 934 of the MMA
CFR Citation: Not Yet Determined
Legal Deadline: NPRM, Statutory, December 8, 2004.
Abstract: This rule implements the statutory requirements regarding the
termination of non-random prepayment review under section 934 of the
Medicare Modernization Act beginning December 8, 2004. This rule
provides guidelines for terminating a provider of services or supplier
from non-random payment review.
Timetable:
________________________________________________________________________
Action                            Date                      FR Cite
________________________________________________________________________
NPRM                            10/07/05                    70 FR 58649
Final Action                    10/00/08
Regulatory Flexibility Analysis Required: No
Small Entities Affected: No
Government Levels Affected: None
Agency Contact: Marie Casey, Health Insurance Specialist, Department of
Health and Human Services, Centers for Medicare & Medicaid Services,
Office of Financial Management, Mailstop S3-02-01, 7500 Security
Boulevard, Baltimore, MD 21244
Phone: 410 786-7861
Email: marie.casey2@cms.hhs.gov
RIN: 0938-AN31
_______________________________________________________________________
1126. LIMITATION ON RECOUPMENT OF OVERPAYMENTS (CMS-6025-P)
Priority: Other Significant. Major status under 5 USC 801 is
undetermined.
Legal Authority: Section 935 of the MMA
CFR Citation: None
Legal Deadline: Final, Statutory, December 8, 2003.
Abstract: This proposed rule would implement one provision of section
935 of the Medicare Modernization Act which added a new subsection to
section 1893 of the Social Security Act. It would prohibit recoupment
where a provider or supplier has appealed an overpayment determination
until the reconsideration-level appeal is decided.
Timetable:
________________________________________________________________________
Action                            Date                      FR Cite
________________________________________________________________________
NPRM                            07/00/06
Regulatory Flexibility Analysis Required: No
Small Entities Affected: No
Government Levels Affected: None
Agency Contact: Nancy Braymer, Health Insurance Specialist, Department
of Health and Human Services, Centers for Medicare & Medicaid Services,
Mailstop C3-14-21, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-4323
Email: nancy.braymer@cms.hhs.gov
RIN: 0938-AN42
_______________________________________________________________________
1127. REVISIONS TO THE OVERSIGHT AND VALIDATION PROGRAM FOR ACCREDITING
ORGANIZATIONS APPROVED FOR DEEMING AUTHORITY (CMS-2255-P)
Priority: Other Significant. Major under 5 USC 801.
Legal Authority: Social Security Act, sec 1864; Social Security Act,
sec 1865; Social Security Act, sec 1875
CFR Citation: 42 CFR 488.1 to 488.9
Legal Deadline: None
Abstract: This proposed rule would respond to the recommendations in
the GAO Report, ``CMS Needs Additional Authority to Adequately Oversee
Patient Safety in Hospitals'' (GAO-04-850). With respect to the
oversight and validation of hospital accreditation programs, a rate of
disparity calculation is specified in Federal regulations at 42 CFR,
488.8. This rule proposes to consider additional alternative measures
to assess the performance of the accreditation organizations.
Timetable:
________________________________________________________________________
Action                            Date                      FR Cite
________________________________________________________________________
NPRM                            07/00/06
Regulatory Flexibility Analysis Required: No
[[Page 64604]]
Small Entities Affected: No
Government Levels Affected: Undetermined
Agency Contact: Amber L. Wolfe, Health Insurance Specialist, Center for
Medicaid and State Operations, Department of Health and Human Services,
Centers for Medicare & Medicaid Services, Survey and Certification
Group, Mailstop S2-12-25, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-6773
Email: amber.wolfe@cms.hhs.gov
RIN: 0938-AN62
_______________________________________________________________________
1128. PHYSICIANS' REFERRALS TO HEALTH CARE ENTITIES WITH WHICH THEY HAVE
FINANCIAL RELATIONSHIPS; EXCEPTIONS FOR CERTAIN ELECTRONIC PRESCRIBING
AND ELECTRONIC HEALTH RECORDS ARRANGEMENTS (CMS-1303-F)
Priority: Other Significant
Legal Authority: 1827(b)(4)-(b)(5); 1860D-4(e)(6); 1860D-42(e)(8)(B)
CFR Citation: 42 CFR 411.357
Legal Deadline: Final, Statutory, January 1, 2006.
Abstract: This rule proposes an exception to the physician self-
referral prohibition for certain nonmonetary remuneration related to
electronic prescribing (section 1860D-4 of the Medicare Modernization
Act).
Timetable:
________________________________________________________________________
Action                            Date                      FR Cite
________________________________________________________________________
NPRM                            10/07/05                    70 FR 59181
Final Action                    10/00/08
Regulatory Flexibility Analysis Required: No
Small Entities Affected: No
Government Levels Affected: None
Agency Contact: Linda Howard, Health Insurance Specialist, Department
of Health and Human Services, Centers for Medicare & Medicaid Services,
C5-13-08, 7500 Security Boulevard, Baltimore, MD 21244-1850
Phone: 410 786-5255
Email: linda.howard@cms.hhs.gov
RIN: 0938-AN69
_______________________________________________________________________
1129. NATIONAL PLAN AND PROVIDER ENUMERATION SYSTEM (NPPES) DATA
DISSEMINATION (CMS-6060-PN)
Priority: Other Significant. Major status under 5 USC 801 is
undetermined.
Legal Authority: HIPAA of 1996, secs 1171 to 1179 of the Social
Security Act (42 USC 1329d to 1320d-8); NPI final rule (01/23/2004);
NPS System of Records (07/28/1998)
CFR Citation: 45 CFR 163
Legal Deadline: None
Abstract: The National Provider Identifier final rule, published
January 23, 2004, stated that CMS would publish a follow-up notice to
describe the data dissemination processes and any applicable charges
for data. This notice describes the data that would be available from
the National Plan and Provider Enumeration System (NPPES), in
compliance with the provisions of the Privacy Act, the Freedom of
Information Act, the Electronic Freedom of Information Act (FOIA)
Amendments of 1996, and other applicable regulations and authorities,
and must be consistent with the National Provider System of Records
Notice, published on July 28, 1998. The notice would describe the data
dissemination strategy, processes, and any applicable charges for data.
Timetable:
________________________________________________________________________
Action                            Date                      FR Cite
________________________________________________________________________
Notice                          02/00/06
Regulatory Flexibility Analysis Required: No
Small Entities Affected: No
Government Levels Affected: None
Agency Contact: Helen Dietrick, Health Insurance Specialist, Department
of Health and Human Services, Centers for Medicare & Medicaid Services,
Office of Financial Management, Program Integrity Group, Mailstop C3-
02-16, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-7448
Email: helen.dietrick@cms.hhs.gov
RIN: 0938-AN71
_______________________________________________________________________
1130. CHANGES TO THE DISCLOSURE OF INFORMATION REQUIREMENTS FOR QUALITY
IMPROVEMENT ORGANIZATIONS (CMS-3156-P)
Priority: Other Significant. Major status under 5 USC 801 is
undetermined.
Legal Authority: sec 1154 to 1160 of the Social Security Act
CFR Citation: Not Yet Determined
Legal Deadline: None
Abstract: This proposed rule would add a provision to the existing
Quality Improvement Organization (QIO) confidentiality regulations
allowing the release of Medicare beneficiary-specific information, with
patient consent, from the QIO to practitioners and providers in a
treatment relationship with the beneficiary. This release may only be
permitted after the beneficiary has consented to the release and has
been provided notice of the release. The new provisions will also
permit the release of Medicare beneficiary-specific information, with
patient consent, from the QIO to other QIOs, subcontractors to QIOs,
and CMS for educational and quality improvement purposes. Additionally,
the rule would add provisions for the Medicare beneficiary complaint
system that is required by the statute and administered by the QIOs.
Timetable:
________________________________________________________________________
Action                            Date                      FR Cite
________________________________________________________________________
NPRM                            09/00/06
Regulatory Flexibility Analysis Required: No
Small Entities Affected: No
Government Levels Affected: None
Agency Contact: Maria L. Hammel, Health Insurance Specialist,
Department of Health and Human Services, Centers for Medicare &
Medicaid Services, Office of Clinical Standards and Quality,
Improvement Group, Mail Stop S3-02-01, 7500 Security Boulevard,
Baltimore, MD 21244-1850
Phone: 410 786-1775
Email: maria.hammel@cms.hhs.gov
RIN: 0938-AN73
[[Page 64605]]
_______________________________________________________________________
1131. HOME HEALTH PAYMENT SYSTEM RATE UPDATE FOR CALENDAR YEAR 2007
(CMS-1304-P)
Priority: Economically Significant. Major under 5 USC 801.
Legal Authority: Social Security Act, sec 1895
CFR Citation: 42 CFR 484
Legal Deadline: Final, None, January 1, 2007, effective date.
Abstract: The proposed rule would set forth an update to the 60-day
national episode rates and the national per-visit amounts under the
Medicare prospective payment system for home health agencies, effective
on January 1, 2007.
Timetable:
________________________________________________________________________
Action                            Date                      FR Cite
________________________________________________________________________
NPRM                            03/00/06
Regulatory Flexibility Analysis Required: Undetermined
Government Levels Affected: Undetermined
Federalism:  Undetermined
Agency Contact: Randy Throndset, Health Insurance Specialist,
Department of Health and Human Services, Centers for Medicare &
Medicaid Services, C5-07-28, 7500 Security Boulevard, Baltimore, MD
21244
Phone: 410 786-0131
Email: rthrondset@ cms.hhs.gov
RIN: 0938-AN76
_______________________________________________________________________
1132. FIRE SAFETY REQUIREMENTS FOR LONG-TERM CARE FACILITIES: SPRINKLER
SYSTEMS (CMS-3191-P)
Priority: Other Significant
Legal Authority: 42 USC 1302; 42 USC 1395hh
CFR Citation: 42 CFR 483
Legal Deadline: None
Abstract: On July 16, 2004, GAO published a report on Federal fire
safety standards and procedures in nursing facilities. The GAO Report
recommended that CMS explore requiring sprinkler systems in all nursing
facilities. This proposed rule would implement this regulation. We
propose to require sprinkler systems in all long-term care facilities
and solicit public comment regarding an appropriate and feasible phase-
in period for this regulation.
Timetable:
________________________________________________________________________
Action                            Date                      FR Cite
________________________________________________________________________
NPRM                            03/00/06
Regulatory Flexibility Analysis Required: No
Small Entities Affected: Businesses
Government Levels Affected: None
Agency Contact: Danielle N. Shearer, Health Insurance Specialist,
Department of Health and Human Services, Centers for Medicare &
Medicaid Services, Clinical Standards Group, Mailstop S3-02-01, 7500
Security Boulevard, Baltimore, MD 21244
Phone: 410 786-6617
Fax: 410 786-8532
Email: danielle.shearer@cms.hhs.gov
RIN: 0938-AN79
_______________________________________________________________________
1133. INPATIENT PSYCHIATRIC FACILITY PROSPECTIVE PAYMENT SYSTEM--UPDATE
FOR 2006 (CMS-1306-P)
Priority: Other Significant. Major status under 5 USC 801 is
undetermined.
Unfunded Mandates: Undetermined
Legal Authority: PL 106-113, sec 124 BBRA
CFR Citation: 42 CFR 412.400, subpart N
Legal Deadline: None
Abstract: This rule would update the Inpatient Psychiatric Facility
Prospective Payment System for 2006. This rule would update and revise
the market basket and the use of new market area definitions.
Timetable:
________________________________________________________________________
Action                            Date                      FR Cite
________________________________________________________________________
NPRM                            01/00/06
Regulatory Flexibility Analysis Required: Undetermined
Small Entities Affected:  Businesses, Governmental Jurisdictions
Government Levels Affected: Local
Federalism:  Undetermined
Agency Contact: Paul Olenick, Director, Division of Technical Payment
Policy, Department of Health and Human Services, Centers for Medicare &
Medicaid Services, Mailstop C5-05-27, 7500 Security Boulevard,
Baltimore, MD 21244
Phone: 410 786-4533
Email: paul.olenick@cms.hhs.gov
Janet Samen, Chronic Care Management and the Chronic Care Policy Group,
Department of Health and Human Services, Centers for Medicare &
Medicaid Services, Mailstop C5-05-07, 7500 Security Boulevard,
Baltimore, MD 21244
Phone: 410 786-9161
Email: janet.samen@cms.hhs.gov
RIN: 0938-AN82
_______________________________________________________________________
1134. [bull] PROSPECTIVE PAYMENT SYSTEM FOR LONG-TERM CARE HOSPITALS FY
2007: ANNUAL PAYMENT RATE UPDATES (CMS-1485-P)
Priority: Economically Significant. Major status under 5 USC 801 is
undetermined.
Legal Authority: sec 123 PL 106-113; sec 307(b), PL 106-554
CFR Citation: 42 CFR 412
Legal Deadline: Final, Statutory, May 1, 2005, To be effective July 1,
2005.
Abstract: This rule proposes the payment rate update for the 2007
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 5/1/06 to be
effective 7/1/06.)
Timetable:
________________________________________________________________________
Action                            Date                      FR Cite
________________________________________________________________________
NPRM                            01/00/06
Regulatory Flexibility Analysis Required: No
Small Entities Affected: Businesses
Government Levels Affected: None
Agency Contact: Judith Richter, Health Insurance Specialist, Department
of Health and Human Services, Centers for Medicare & Medicaid Services,
7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-2590
Email: jrichter@cms.hhs.gov
RIN: 0938-AO06
_______________________________________________________________________
1135. [bull] PAYMENTS FOR SERVICE PROVIDED WITHOUT CHARGE (CMS-2489-P)
Priority: Other Significant. Major status under 5 USC 801 is
undetermined.
Unfunded Mandates: Undetermined
Legal Authority: Not Yet Determined
[[Page 64606]]
CFR Citation: Not Yet Determined
Legal Deadline: None
Abstract: This proposed rule would increase States' accountability for
Federal Financial participation (FFP) provided for certain services
furnished without charge to (but not limited to) the following groups:
children residing in various foster care settings; juvenile offenders
residing in detention, correctional, or shelter facilities; and others.
The rule would clarify circumstances under which Federal financial
participation (FFP) will or will not be made available to States on
behalf of Medicaid beneficiaries in instances where the services are
provided free of charge to all users in the community. The regulation
would specify the criteria for determining when a service is free.
Timetable:
________________________________________________________________________
Action                            Date                      FR Cite
________________________________________________________________________
NPRM                            08/00/06
Regulatory Flexibility Analysis Required: Undetermined
Small Entities Affected:  Governmental Jurisdictions
Government Levels Affected: Undetermined
Federalism:  Undetermined
Agency Contact: Ellen W. Blackwell, Disability & Elderly Health
Programs Group, Department of Health and Human Services, Centers for
Medicare & Medicaid Services, Center for Medicaid State Operations,
Mailstop S2-26-12, 7500 Security Boulevard, Baltimore, MD 21244-1850
Phone: 410 786-4498
Fax: 410 786-3262
Email: ellen.blackwell@cms.hhs.gov
RIN: 0938-AO07
_______________________________________________________________________
1136. [bull] REVISIONS TO PAYMENT OF AMBULANCE SERVICES UNDER MEDICARE
(CMS-1317-P)
Priority: Substantive, Nonsignificant
Legal Authority: Section 1834(1) of the Social Security Act (the Act).
CFR Citation: 42 CFR 414.605; 42 CFR 412.64; 42 CFR 410.40
Legal Deadline: None
Abstract: This rule would revise the fee schedule for payment of
ambulance services specifically with respect to the definition of
Specialty Care Transport (SCT) and the Metropolitan Statistical Area
(MSA) geographic breakdown in relation to payment of ambulance services
under Medicare. In addition, this proposed rule, discusses the
conversion factor and the effect of low billers.
Timetable:
________________________________________________________________________
Action                            Date                      FR Cite
________________________________________________________________________
NPRM                            01/00/06
Regulatory Flexibility Analysis Required: Undetermined
Small Entities Affected:  Businesses
Government Levels Affected: None
Agency Contact: Anne Elizabeth Tayloe, Health Insurance Specialist,
Department of Health and Human Services, Centers for Medicare &
Medicaid Services, Mailstop C4-06-28, 7500 Security Boulevard,
Baltimore, MD 21244-1850
Phone: 410 786-4546
Email: anne.tayloe@cms.hhs.gov
RIN: 0938-AO11
_______________________________________________________________________
1137. [bull] CHANGES TO THE HOSPITAL INPATIENT PROSPECTIVE PAYMENT
SYSTEMS AND FY 2007 RATES (CMS-1488-P)
 Regulatory Plan: This entry is Seq. No. 52 in part II of this issue of
the Federal Register.
RIN: 0938-AO12
_______________________________________________________________________
1138. [bull] REVISED PAYMENT SYSTEM FOR SERVICES FURNISHED IN AMBULATORY
SURGICAL CENTERS (ASCS) EFFECTIVE JANUARY 1, 2008 (CMS-1517-P)
Priority: Economically Significant. Major under 5 USC 801.
Unfunded Mandates: Undetermined
Legal Authority: 42 CFR 416, Social Security Act 1832(2)(F) and
1833(i), as amended by section 626 of the Medicare Modernization Act
CFR Citation: 42 FR 416
Legal Deadline: Final, Statutory, November 1, 2007.
Abstract: This rule, proposes to revise the method by which Medicare
sets payment rates for ASC facility services, and will propose new
payment rates for ASC services in accordance with that methodology.
(Effective January 1, 2008).
Timetable:
________________________________________________________________________
Action                            Date                      FR Cite
________________________________________________________________________
NPRM                            04/00/06
Regulatory Flexibility Analysis Required: Yes
Small Entities Affected: Organizations
Government Levels Affected: Federal
Federalism:  Undetermined
Agency Contact: Joan H. Sanow, Deputy Director, Division of Outpatient
Care, Department of Health and Human Services, Centers for Medicare &
Medicaid Services, Center for Medicare Management, Mailstop C4-03-18,
7500 Security Boulevard, Baltimore, MD 21244-1850
Phone: 410 786-9739
Fax: 410 786-4490
Email: joan.sanow@cms.hhs.gov
RIN: 0938-AO13
_______________________________________________________________________
1139. [bull] CHANGES TO THE HOSPITAL OUTPATIENT PROSPECTIVE PAYMENT
SYSTEM AND CALENDAR YEAR 2007 PAYMENT RATES (CMS-1506-P)
Priority: Substantive, Nonsignificant
Legal Authority: BBA; BBRA; BIPA; MMA
CFR Citation: 42 CFR 419 and 485
Legal Deadline: Final, None, November 1, 2006.
Abstract: This proposed rule would revise the Medicare hospital
outpatient prospective payment system to implement applicable statutory
requirements and changes arising from our continuing experience with
this system and to implement certain related provisions of the Medicare
Modernization Act (MMA) of 2003. In addition, the proposed rule
describes proposed changes to the amounts and factors used to determine
the payment rates for Medicare hospital outpatient services paid under
the prospective payment system. These changes would be applicable to
services furnished on or after January 1, 2007.
Timetable:
________________________________________________________________________
Action                            Date                      FR Cite
________________________________________________________________________
NPRM                            07/00/06
Regulatory Flexibility Analysis Required: Yes
Small Entities Affected: Businesses
Government Levels Affected: Federal
[[Page 64607]]
Federalism:  This action may have federalism implications as defined in
EO 13132.
Agency Contact: Rebecca Kane, Health Insurance Specialist, Center for
Medicare Management, Hospital & Ambulatory Policy Group, Department of
Health and Human Services, Centers for Medicare & Medicaid Services,
Division Group of Outpatient Care, Mailstop C5-01-28, 7500 Security
Boulevard, Baltimore, MD 21244-1850
Phone: 410 786-1589
Email: rebecca.kane@cms.hhs.gov
RIN: 0938-AO15
_______________________________________________________________________
1140. [bull] PROSPECTIVE PAYMENT SYSTEM FOR INPATIENT REHABILITATION
FACILITIES FOR FY 2007 (CMS-1540-P)
Priority: Economically Significant. Major status under 5 USC 801 is
undetermined.
Unfunded Mandates: Undetermined
Legal Authority: Section 1866(l) of the Social Security Act; ; PL 105-
33; PL 106-554; PL 106-113
CFR Citation: 42 CFR 412
Legal Deadline: Final, None, August 1, 2006.
Abstract: This proposed rule would update rates for the prospective
payment system for inpatient rehabilitation facilities for FY 2007.
(Effective October 1, 2006).
Timetable:
________________________________________________________________________
Action                            Date                      FR Cite
________________________________________________________________________
NPRM                            04/00/06
Regulatory Flexibility Analysis Required: Undetermined
Government Levels Affected: Undetermined
Federalism:  Undetermined
Agency Contact: Robert Kuhl, Division Director of Center for Medicaid
and Medicare, Department of Health and Human Services, Centers for
Medicare & Medicaid Services, Mailstop C5-06-24, 7500 Security
Boulevard, Baltimore, MD 21244-1850
Phone: 410 786-4597
Email: bkuhl@cms.hhs.gov
RIN: 0938-AO16
_______________________________________________________________________
1141. [bull] OUTPATIENT HOSPITAL SERVICES AND RURAL HEALTH CLINIC
SERVICES AMENDMENT (CMS-2213-P)
Priority: Economically Significant. Major under 5 USC 801.
Legal Authority: Section 1102 of the Social Security Act
CFR Citation: 42 CFR 440.20
Legal Deadline: None
Abstract: This rule would amend the definition of outpatient hospital
services for the Medicaid program. The purpose of this amendment is to
clarify the scope of services available for federal financial
participation (FFP) under the outpatient hospital services benefit
category.
Timetable:
________________________________________________________________________
Action                            Date                      FR Cite
________________________________________________________________________
NPRM                            08/00/06
Regulatory Flexibility Analysis Required: Undetermined
Small Entities Affected:  Businesses
Government Levels Affected: None
Federalism:  Undetermined
Agency Contact: Jeremy Silanskis, Health Insurance Specialist, Center
for Medicaid Services, Department of Health and Human Services, Centers
for Medicare & Medicaid Services, Center for Medicaid and State
Operations, Mailstop S3-13-15, 7500 Security Boulevard, Baltimore, MD
21244-1850
Phone: 410 786-1592
Fax: 410 786-8533
Email: jeremy.silanskis@cms.hhs.gov
RIN: 0938-AO17
_______________________________________________________________________
1142. [bull] FIVE YEAR REVIEW OF WORK RELATIVE VALUE UNITS UNDER THE
PHYSICIAN FEE SCHEDULE (CMS-1512-PN)
Priority: Economically Significant. Major under 5 USC 801.
Unfunded Mandates: Undetermined
Legal Authority: Social Security Act sec 1848
CFR Citation: Not Yet Determined
Legal Deadline: Other, Statutory, April 2006, Proposed notice. Comments
to be addressed as part of final physician fee.
Final, Statutory, November 1, 2006.
Abstract: This notice discusses changes to work relative value units
(RVUs) affecting payment for physician services. Comments on this
notice will be addressed as part of the final physician fee schedule
rule required to be published by 11/01/06.
Timetable:
________________________________________________________________________
Action                            Date                      FR Cite
________________________________________________________________________
NPRM                            04/00/06
Regulatory Flexibility Analysis Required: Undetermined
Small Entities Affected:  Businesses
Government Levels Affected: Undetermined
Federalism:  Undetermined
Agency Contact: Diane Milstead, Health Insurance Specialist, Center of
Medicare and Medicaid, Department of Health and Human Services, Centers
for Medicare & Medicaid Services, Mailstop C4-03-06, 7500 Security
Boulevard, Baltimore, MD 21244-1850
Phone: 410 786-3355
Email: diane.milstead@cms.hhs.gov
RIN: 0938-AO22
_______________________________________________________________________
1143. [bull] REVISIONS TO PAYMENT POLICIES UNDER THE PHYSICIAN FEE
SCHEDULE FOR CALENDAR YEAR 2007 (CMS-1321-P)
Priority: Economically Significant. Major under 5 USC 801.
Unfunded Mandates: Undetermined
Legal Authority: Social Security Act, sec 1102; Social Security Act,
sec 1871
CFR Citation: 42 CFR 405; 42 CFR 410; 42 CFR 411; 42 CFR 413; 42 CFR
414; 42 CFR 426
Legal Deadline: Final, Statutory, November 1, 2006.
Abstract: This rule would make several changes affecting Medicare Part
B payment. (The statute requires the final rule be published by 11/01/
06.)
Timetable:
________________________________________________________________________
Action                            Date                      FR Cite
________________________________________________________________________
NPRM                            07/00/06
Regulatory Flexibility Analysis Required: Undetermined
Government Levels Affected: Undetermined
Federalism:  Undetermined
Agency Contact: Diane Milstead, Health Insurance Specialist, Center for
Medicare and Medicaid Services, Department of Health and Human
Services, Centers for Medicare &
[[Page 64608]]
Medicaid Services, Mailstop C4-03-06, 7500 Security Boulevard,
Baltimore, MD 21244-1850
Phone: 410 786-3355
Email: diane.milstead@cms.hhs.gov
RIN: 0938-AO24
_______________________________________________________________________
1144. [bull] USE OF REPAYMENT PLANS (CMS-6032-P)
Priority: Other Significant
Legal Authority: Section 1893(i)(1) of the Social Security Act as
amended by sec. 935(i)(1) of Medicare Modernization Act (MMA)
CFR Citation: 42 CFR 401.607, 42 CFR 401.601
Legal Deadline: Final, Statutory, December 9, 2003.
Abstract: This rule would implement a provision of section 935 of the
MMA and adds a new subsection to section 1893 (42 U.S.C. 1395ddd) of
the Social Security Act. The provision, ``Use of Repayment Plans,''
requires CMS to enter into a repayment plan with a provider or supplier
when repaying a Medicare overpayment would be a hardship for the
provider or supplier absent specific exceptions. The rule would
establish criteria and procedures to apply this requirement to include
the concepts of extreme hardship and the discretionary right to
accelerate upon default.
Timetable:
________________________________________________________________________
Action                            Date                      FR Cite
________________________________________________________________________
NPRM                            04/00/06
Regulatory Flexibility Analysis Required: No
Small Entities Affected: No
Government Levels Affected: None
Agency Contact: Thomas A. Noplock, Health Insurance Specialist,
Division of Medicare Overpayments, Office of Financial Management,
Department of Health and Human Services, Centers for Medicare &
Medicaid Services, Financial Services Group, Mailstop C3-15-01, 7500
Security Boulevard, Baltimore, MD 21244-1850
Phone: 410 786-3378
Fax: 410 786-7030
Email: thomas.noplock@cms.hhs.gov
RIN: 0938-AO27
_______________________________________________________________________
Department of Health and Human Services (HHS)          Final Rule Stage
Centers for Medicare & Medicaid Services (CMS)
_______________________________________________________________________
1145. 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: Final, Statutory, April 25, 2006, MMA 902.
Abstract: This final rule requires that all providers and suppliers
(other than physicians who have elected to ``opt-out'' of the Medicare
program) complete an enrollment form and submit specific information to
CMS. This rule will requires that all providers and suppliers
periodically update and certify the accuracy of their enrollment
information to receive and maintain billing privileges in the Medicare
program. In addition, this final rule will implement provisions in the
Medicare statute that require CMS to ensure that all Medicare providers
and suppliers are qualified to provide the appropriate health care
services. These statutory provisions include requirements meant to
protect beneficiaries and the Medicare Trust Funds by preventing
unqualified, fraudulent, or excluded providers and suppliers from
providing items or services to Medicare beneficiaries or billing the
Medicare program or its beneficiaries.
Timetable:
________________________________________________________________________
Action                            Date                      FR Cite
________________________________________________________________________
NPRM                            04/25/03                    68 FR 22064
Final Action                    04/00/06
Regulatory Flexibility Analysis Required: No
Small Entities Affected: Businesses
Government Levels Affected: None
Agency Contact: Michael Collett, Health Insurance Specialist,
Department of Health and Human Services, Centers for Medicare &
Medicaid Services, Office of Financial Management, Program Integrity
Group, Division of Provider/Supplier Enrollment, N3-22-17, 7500
Security Boulevard, Baltimore, MD 21244
Phone: 410 786-6121
RIN: 0938-AH73
_______________________________________________________________________
1146. HOSPITAL CONDITIONS OF PARTICIPATION: LABORATORY SERVICES (CMS-
3014-IFC) (SECTION 610 REVIEW)
Priority: Substantive, Nonsignificant
Legal Authority: 42 USC 1302; 42 USC 1395hh
CFR Citation: 42 CFR 482
Legal Deadline: None
Abstract: This interim final rule with comment period requires
hospitals that transfuse blood and blood products to prepare and follow
written procedures for appropriate action when it is determined that
blood and blood products the hospital received and transfused are at
increased risk for transmitting hepatitis C virus (HCV); quarantine
prior collections from a donor who is at increased risk for
transmitting HCV infection; notify transfusion recipients, as
appropriate, of the need for HCV testing and counseling; and maintain
records for at least 10 years.
Timetable:
________________________________________________________________________
Action                            Date                      FR Cite
________________________________________________________________________
NPRM                            11/16/00                    65 FR 69416
Interim Final Rule With Comment 03/00/06
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,
Clinical Standards Group, Mailstop S3-02-01, 7500 Security Boulevard,
Baltimore, MD 21244
Phone: 410 786-3189
Email: mary.collins@cms.hhs.gov
RIN: 0938-AJ29
[[Page 64609]]
_______________________________________________________________________
1147. 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: Final, Statutory, November 22, 2005, MMA 902.
Abstract: This final rule revises certain regulations governing
coverage and payments for hospice care under the Medicare program as
required by the Balanced Budget Act of 1997.
Timetable:
________________________________________________________________________
Action                            Date                      FR Cite
________________________________________________________________________
NPRM                            11/22/02                    67 FR 70363
Final Action                    11/00/05
Regulatory Flexibility Analysis Required: No
Small Entities Affected: Businesses
Government Levels Affected: None
Agency Contact: Linda Smith, Health Insurance Specialist, Department of
Health and Human Services, Centers for Medicare & Medicaid Services,
Chronic Care Policy Group, Mailstop C5-02-24, 7500 Security Boulevard,
Baltimore, MD 21244
Phone: 410 786-5650
Related RIN: Previously reported as 0938-AH73
RIN: 0938-AJ36
_______________________________________________________________________
1148. USE OF RESTRAINT AND SECLUSION IN RESIDENTIAL TREATMENT FACILITIES
PROVIDING INPATIENT PSYCHIATRIC SERVICES TO INDIVIDUALS UNDER AGE 21
(CMS-2065-F)
Priority: Other Significant
Legal Authority: 42 USC 1302; 42 USC 1396d
CFR Citation: 42 CFR 441; 42 CFR 442; 42 CFR 483
Legal Deadline: None
Abstract: This rule addresses standards of practice that residential
treatment facilities providing inpatient psychiatric services for
individuals under age 21 must meet with regard to the use of restraints
(including psychoactive drugs) and seclusion.
Timetable:
________________________________________________________________________
Action                            Date                      FR Cite
________________________________________________________________________
Interim Final Rule              01/22/01                     66 FR 7148
60-Day Delay of Effective Date
To 05/22/2001                   03/21/01                    66 FR 15800
Interim Final Rule Comment
Period End                      03/23/01
Interim Final Rule Effective    03/23/01
Interim Final Rule Amendment
with Clarification              05/22/01                    66 FR 28110
Interim Final Rule Comment
Period End                      07/23/01
Final Action                    09/00/06
Regulatory Flexibility Analysis Required: No
Small Entities Affected: Businesses
Government Levels Affected: None
Agency Contact: Mary Clarkson, Health Insurance Specialist, Disabled &
Elderly Health Programs Group, Department of Health and Human Services,
Centers for Medicare & Medicaid Services, Division of Benefits &
Coverage Policy, Mailstop S2-12-11, 7500 Security Boulevard, Baltimore,
MD 21244-1850
Phone: 410 786-5918
Email: mary.clarkson@cms.hhs.gov
RIN: 0938-AJ96
_______________________________________________________________________
1149. ORGAN PROCUREMENT ORGANIZATION CONDITIONS FOR COVERAGE (CMS-3064-
IFR) (SECTION 610 REVIEW)
 Regulatory Plan: This entry is Seq. No. 53 in part II of this issue of
the Federal Register.
RIN: 0938-AK81
_______________________________________________________________________
1150. PAYMENT FOR RESPIRATORY ASSIST DEVICES WITH BI-LEVEL CAPABILITY
AND A BACK-UP RATE (CMS-1167-F)
Priority: Other Significant
Legal Authority: 42 USC 1395(m)(3)
CFR Citation: 42 CFR 414.222(a)(1)
Legal Deadline: Final, Statutory, August 22, 2006, MMA, section 902.
Abstract: This final rule clarifies that respiratory assist devices
with bi-level capability and a back-up rate must be classified as
capped rental durable medical equipment (DME) in accordance with
section 1834(a)(3) of the Social Security Act (42 U.S.C. 1395(m)(3)).
Timetable:
________________________________________________________________________
Action                            Date                      FR Cite
________________________________________________________________________
NPRM                            08/22/03                    68 FR 50735
Final Action                    08/00/06
Regulatory Flexibility Analysis Required: Yes
Small Entities Affected: Businesses
Government Levels Affected: None
Agency Contact: Joel Kaiser, Health Insurance Specialist, Department of
Health and Human Services, Centers for Medicare & Medicaid Services,
Center for Medicare Management, Chronic Care Policy Group, Mailstop C5-
07-26, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-4499
Email: joel.kaiser@cms.hhs.gov
Related RIN: Related to 0938-AL27
RIN: 0938-AN02
_______________________________________________________________________
1151. ENHANCED DSH TREATMENT FOR CERTAIN HOSPITALS (CMS-2198-F)
Priority: Other Significant
Legal Authority: Section 1923(i) of the Social Security Act
CFR Citation: Not Yet Determined
Legal Deadline: None
Abstract: This rule implements section 1001(d) of the Medicare
Modernization Act which requires States to report additional
information about their disproportionate share hospital (DSH) programs
to their annual report. This section also requires States to
independently audit and submit these certified audits annually to the
Secretary (effective December 8, 2003).
Timetable:
________________________________________________________________________
Action                            Date                      FR Cite
________________________________________________________________________
NPRM                            08/26/05                    70 FR 50262
Final Action                    09/00/06
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,
Mailstop S3-13-15, 7500 Security Boulevard, Baltimore, MD 21244
[[Page 64610]]
Phone: 410 786-3263
Email: james.frizzera@cms.hhs.gov
RIN: 0938-AN09
_______________________________________________________________________
1152. UPDATE OF THE LIST OF COVERED PROCEDURES FOR AMBULATORY SURGICAL
CENTERS FOR 2005 (CMS-1478-IFC)
Priority: Other Significant
Legal Authority: Not Yet Determined
CFR Citation: None
Legal Deadline: Final, Statutory, July 1, 2005.
Abstract: This final rule updates the list of Medicare-covered ASC
procedures.
Timetable:
________________________________________________________________________
Action                            Date                      FR Cite
________________________________________________________________________
NPRM                            11/26/04                    69 FR 69178
Interim Final Rule              05/04/05                    70 FR 23690
Final Action                    01/00/06
Regulatory Flexibility Analysis Required: Undetermined
Government Levels Affected: None
Agency Contact: Dana Burley, Health Insurance Specialist, Department of
Health and Human Services, Centers for Medicare & Medicaid Services,
Center for Medicare Management, Hospital and Ambulatory Policy Group,
Mailstop C4-05-17, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-4547
Email: dana.burley@cms.hhs.gov
RIN: 0938-AN23
_______________________________________________________________________
1153. MEDICARE SECONDARY PAYER AMENDMENTS (CMS-6272-IFC)
Priority: Substantive, Nonsignificant. Major status under 5 USC 801 is
undetermined.
Legal Authority: Sec 301 of the Medicare Modernization Act of 2003
CFR Citation: 42 CFR 411; 42 CFR 489
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 02/00/06
Regulatory Flexibility Analysis Required: No
Government Levels Affected: Undetermined
Agency Contact: Jeremy Silanskis, Health Insurance Specialist,
Department of Health and Human Services, Centers for Medicare &
Medicaid Services, Centers for Medicaid Services Office, Mail Stop S3-
13-15, 7500 Security Boulevard, Baltimore, MD 21244-1850
Phone: 410 786-1592
Fax: 410 786-8533
Email: jeremy.silanskis@cms.hhs.gov
RIN: 0938-AN27
_______________________________________________________________________
1154. HOME HEALTH PROSPECTIVE PAYMENT SYSTEM RATE UPDATE FOR CALENDAR
YEAR 2006 (CMS-1301-F)
Priority: Economically Significant. Major under 5 USC 801.
Legal Authority: Sec 1895 of the Social Security Act
CFR Citation: 42 CFR 484
Legal Deadline: Final, Statutory, November 1, 2005.
Abstract: This rule updates 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                            07/14/05                    70 FR 40788
Final Action                    11/00/05
Regulatory Flexibility Analysis Required: Undetermined
Government Levels Affected: Undetermined
Agency Contact: Randy Throndset, Health Insurance Specialist, Division
of Community Post Acute Care, Department of Health and Human Services,
Centers for Medicare & Medicaid Services, Center for Medicare
Management, C5-09-15, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-0131
Email: randy.throndset@cms.hhs.gov
RIN: 0938-AN44
_______________________________________________________________________
1155. CHANGES TO THE HOSPITAL OUTPATIENT PROSPECTIVE PAYMENT SYSTEM AND
CALENDAR YEAR 2006 PAYMENT RATES (CMS-1501-FC)
 Regulatory Plan: This entry is Seq. No. 54 in part II of this issue of
the Federal Register.
RIN: 0938-AN46
_______________________________________________________________________
1156. ALL PROVIDER BAD DEBT PAYMENT (CMS-1126-F)
Priority: Other Significant
Legal Authority: SSA, sec 1834
CFR Citation: 42 CFR 412; 42 CFR 413; 42 CFR 1902
Legal Deadline: Final, Statutory, February 10, 2006, MMA sec. 902.
Abstract: This final rule will achieve a consistent bad debt
reimbursement policy for all providers currently eligible to receive
payments from Medicare for bad debt. It implements a court settlement
agreement and removes the cap on End Stage Renal Disease (ESRD) bad
debt reimbursement, which limits payment of allowable bad debts to the
facility's unrecovered costs.
Timetable:
________________________________________________________________________
Action                            Date                      FR Cite
________________________________________________________________________
NPRM                            02/10/03                     68 FR 6682
Final Action                    02/00/06
Regulatory Flexibility Analysis Required: No
Small Entities Affected: Businesses
Government Levels Affected: Federal
Agency Contact: Katie Walker, Health Insurance Specialist, Department
of Health and Human Services, Centers for Medicare & Medicaid Services,
Center of Medicare Management, Mailstop C5-03-03, 7500 Security
Boulevard, Baltimore, MD 21244
Phone: 410 786-7278
Email: katie.walker@cms.hhs.gov
Related RIN: Related to 0938-AK02
RIN: 0938-AN75
_______________________________________________________________________
1157. PAYMENT ERROR RATE MEASUREMENT (PERM) PROGRAM (CMS-6026-F)
Priority: Other Significant
Legal Authority: Improper Payment Information Act of 2002
CFR Citation: 42 CFR 431; 42 CFR 457
[[Page 64611]]
Legal Deadline: Final, Statutory, October 1, 2005.
Abstract: This rule requires States to estimate improper payments in
the Medicaid program and the State Children's Health Insurance Program.
The State level estimates will be used to produce estimates of improper
payments for both Medicaid and SCHIP at the national level. These
national level estimates will enable us to comply with the Improper
Payments Information Act of 2002. The intended effect of this
regulation is for States to produce estimates of improper payments for
their Medicaid and SCHIP programs and identify existing and emerging
vulnerabilities that can be effectively targeted for corrective actions
by the States.
Timetable:
________________________________________________________________________
Action                            Date                      FR Cite
________________________________________________________________________
NPRM                            08/27/04                    69 FR 52620
Interim Final Rule              10/05/05                    70 FR 58260
Final Action                    10/00/08
Regulatory Flexibility Analysis Required: No
Government Levels Affected: State
Agency Contact: Chrstine Jones, Division Director, Department of Health
and Human Services, Centers for Medicare & Medicaid Services, Office of
Financial Management, Mail stop C3-02-16, 7500 Security Boulevard,
Baltimore, MD 21244
Phone: 410 786-3722
Email: christine.jones@cms.hhs.gov
Related RIN: Related to 0938-AM86
RIN: 0938-AN77
_______________________________________________________________________
1158. REVISIONS TO PAYMENT POLICIES UNDER THE PHYSICIAN FEE SCHEDULE FOR
CALENDAR YEAR 2006 (CMS-1502-FC)
 Regulatory Plan: This entry is Seq. No. 55 in part II of this issue of
the Federal Register.
RIN: 0938-AN84
_______________________________________________________________________
1159. [bull] FEE SCHEDULE FOR PAYMENT OF AMBULANCE SERVICES -- UPDATE
FOR CY 2006 (CMS-1294-N)
Priority: Economically Significant. Major under 5 USC 801.
Unfunded Mandates: Undetermined
Legal Authority: Sec 1834(1) of the Social Security Act
CFR Citation: 42 CFR 410
Legal Deadline: None
Abstract: This notice updates the fee schedule for ambulance services
under the Medicare program, implementing section 1834(1) of the Social
Security Act. (effective January 1, 2006)
Timetable:
________________________________________________________________________
Action                            Date                      FR Cite
________________________________________________________________________
Notice                          11/00/05
Regulatory Flexibility Analysis Required: Undetermined
Government Levels Affected: Undetermined
Federalism:  Undetermined
Agency Contact: Anne Tayloe, Health Insurance Specialist, Department of
Health and Human Services, Centers for Medicare & Medicaid Services,
Center for Medicaid and State Operations, Mailstop C4-07-07, 7500
Security Boulevard, Baltimore, MD 21244
Phone: 410 786-4546
Email: anne.tayloe@cms.hhs.gov
RIN: 0938-AN99
_______________________________________________________________________
1160. [bull] STATE ALLOTMENTS FOR PAYMENT OF MEDICARE PART B PREMIUMS
FOR QUALIFYING INDIVIDUALS (CMS-2210-F)
Priority: Other Significant
Legal Authority: Section 4732 of the Balanced Budget Act of 1997 (PL
105-33)
CFR Citation: Not Yet Determined
Legal Deadline: None
Abstract: Section 4732 of the Balanced Budget Act amended the Social
Security Act to provide for certain low income Medicare Beneficiaries
(also known as Qualified Individuals, or QIs) for whom Medicaid payment
can be made for Medicare Part B premiums. Section 1933(c) of the Act
limits the total amount of Federal funds available for payment of Part
B premiums each fiscal year and specifies the formula to be used to
determine an allotment for each State from this total amount. States
must limit the number of QIs so that the amount of assistance provided
during the fiscal year is approximately equal to the allotment for that
year. For FY 2005 some States have experienced a deficit in their
allotments which has necessitated denial of benefits to applicants
after a certain date, while other States project that they will not
utilize their full allotments. To fully utilize the authorized funding
and to prevent denial of benefits to eligible applicants, the FY 2005
funds will be reallocated based on current data available from States.
This interim final rule with comment period announces the reallocation
of funds available to States for FY 2005 and describes the methodology
used to determine each State's allotment.
Timetable:
________________________________________________________________________
Action                            Date                      FR Cite
________________________________________________________________________
Interim Final Rule              08/26/05                    70 FR 50214
Comment Period End              10/25/05
Final Action                    08/00/08
Regulatory Flexibility Analysis Required: No
Small Entities Affected: No
Government Levels Affected: State
Agency Contact: Richard Strauss, Technical Director Finance Systems &
Budget Group, Department of Health and Human Services, Centers for
Medicare & Medicaid Services, Center for Medicare State Operations,
Mailstop S3-13-15, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-2019
Email: richard.strauss@cms.hhs.gov
RIN: 0938-AO04
_______________________________________________________________________
1161. [bull] FEDERAL GOVERNMENT'S ADOPTION OF TWENTY (20) HEALTHCARE
MESSAGING AND VOCABULARY STANDARDS RECOMMENDED BY THE CONSOLIDATED
HEALTH INFORMATICS INITIATIVE (CMS-0015-N)
Priority: Other Significant
Legal Authority: Not Yet Determined
CFR Citation: None
Legal Deadline: None
Abstract: This notice identifies the 20 messaging and vocabulary
standards adopted for use by the Federal government health information
technology systems. The first set of 5 standards were adopted on 3/21/
03, and the second set of 15 standards were adopted on 5/6/04, which
completed the initial portfolio of the Consolidated Health Informatics
initiative.
Timetable:
________________________________________________________________________
Action                            Date                      FR Cite
________________________________________________________________________
Notice                          12/00/05
[[Page 64612]]
Regulatory Flexibility Analysis Required: No
Small Entities Affected: No
Government Levels Affected: Federal
Agency Contact: Alicia Bradford, Office of HIPAA Standards, Director,
Department of Health and Human Services, Centers for Medicare &
Medicaid Services, 7500 Security Boulevard, Mailstop C5-25-04,
Baltimore, MD 21244-1850
Phone: 410 786-4160
RIN: 0938-AO05
_______________________________________________________________________
1162. [bull] FIRE SAFETY REQUIREMENTS FOR RELIGIOUS NON-MEDICAL HEALTH
CARE INSTITUTIONS: CORRECTION TO ADD WRITTEN FIRE CONTROL PLANS &
MAINTENANCE OF DOCUMENTATION (CMS-3183-IFC)
Priority: Other Significant
Legal Authority: 42 USC.1395hh; 42 USC 1302
CFR Citation: 42 CFR 403
Legal Deadline: None
Abstract: On January 10, 2003, CMS issued a final rule amending the
fire safety standards for religious non-medical 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. This final rule
adopted, with certain exceptions, the 2000 edition of the Life Safety
Code (LSC) published by the National Fire Protection Assoc. (NFPA). On
August 11, 2004, the final Inpatient PPS rule was published. The LSC
provisions in the August rule were meant to clarify the effective date
of the roller latch prohibition. The clarifying regulatory language was
accidentally deleted. These requirements will be restored by this
regulation.
Timetable:
________________________________________________________________________
Action                            Date                      FR Cite
________________________________________________________________________
Interim Final Rule              06/00/06
Regulatory Flexibility Analysis Required: No
Small Entities Affected: Businesses
Government Levels Affected: None
Agency Contact: Janice A. Graham RN, Health Insurance Specialist,
Clinical Standards Group, Department of Health and Human Services,
Centers for Medicare & Medicaid Services, Office of Clinical Standards
and Quality, Mailstop S3-02-01, 7500 Security Boulevard, Baltimore, MD
21244-1850
Phone: 410 786-8020
Fax: 410 786-2532
Email: janice.graham@cms.hhs.gov
RIN: 0938-AO14
_______________________________________________________________________
1163. [bull] PART A PREMIUMS FOR CALENDAR YEAR 2007 FOR THE UNINSURED
AGED AND FOR CERTAIN DISABLED INDIVIDUALS WHO HAVE EXHAUSTED OTHER
ENTITLEMENT (CMS-8028-N)
Priority: Other Significant. Major under 5 USC 801.
Legal Authority: 42 USC 1395i-2(d)(2); 42 USC 1395i-2a(d)(2); Social
Security Act, Section 1818(d)(2); Social Security Act, section 1818
A(d)(2)
CFR Citation: None
Legal Deadline: Final, Statutory, September 30, 2006.
Abstract: This notice announces the hospital insurance premium for
Calendar Year 2007 under Medicare's Hospital Insurance program
(Medicare Part A) for the uninsured aged and for certain disabled
individuals who have exhausted other entitlement.
Timetable:
________________________________________________________________________
Action                            Date                      FR Cite
________________________________________________________________________
Final Action                    09/00/06
Regulatory Flexibility Analysis Required: No
Small Entities Affected: No
Government Levels Affected: None
Agency Contact: Clare McFarland, Division Director, Medicare and
Medicaid Cost Estimates Group, Department of Health and Human Services,
Centers for Medicare & Medicaid Services, Office of the Actuary,
Mailstop N3-26-00, 7500 Security Boulevard, Baltimore, MD 21244-1850
Phone: 410 786-6390
Email: clare.mcfarland@cms.hhs.gov
RIN: 0938-AO18
_______________________________________________________________________
1164. [bull] INPATIENT HOSPITAL DEDUCTIBLE AND HOSPITAL AND EXTENDED
CARE SERVICES COINSURANCE AMOUNTS FOR CALENDAR YEAR 2007 (CMS-8029-N)
Priority: Other Significant. Major under 5 USC 801.
Legal Authority: 42 USC 1395e-2(b)(2); Social Security Act, section
1813 (b)(2)
CFR Citation: None
Legal Deadline: Final, Statutory, September 15, 2006.
Abstract: This notice announces the inpatient hospital deductible and
the hospital and extended care services coinsurance amounts for
services furnished in Calendar Year 2007 under Medicare's Hospital
Insurance program (Medicare Part A). The Medicare statute specifies the
formulae used to determine these amounts.
Timetable:
________________________________________________________________________
Action                            Date                      FR Cite
________________________________________________________________________
Final Action                    09/00/06
Regulatory Flexibility Analysis Required: No
Small Entities Affected: No
Government Levels Affected: None
Agency Contact: Clare McFarland, Division Director, Medicare and
Medicaid Cost Estimates Group, Department of Health and Human Services,
Centers for Medicare & Medicaid Services, Office of Actuary, Mailstop
N3-26-00, 7500 Security Boulevard, Baltimore, MD 21244-1850
Phone: 410 786-6390
Email: clare.mcfarland@cms.hhs.gov
RIN: 0938-AO19
_______________________________________________________________________
1165. [bull] FISCAL YEAR 2007 SCHIP ALLOTMENTS (CMS-2251-N)
Priority: Other Significant
Legal Authority: Title XXI of the Social Security Act, sec 2104
CFR Citation: 42 CFR 457
Legal Deadline: Final, Statutory, September 30, 2006.
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 2007.
Timetable:
________________________________________________________________________
Action                            Date                      FR Cite
________________________________________________________________________
Final Notice                    06/00/06
[[Page 64613]]
Regulatory Flexibility Analysis Required: No
Small Entities Affected: No
Government Levels Affected: State
Agency Contact: Richard Strauss, Technical Director, Department of
Health and Human Services, Centers for Medicare & Medicaid Services,
Center for Medicaid State Operations, Mailstop S3-13-15, 7500 Security
Boulevard, Baltimore, MD 21244-1850
Phone: 410 786-2019
Email: richard.strauss@cms.hhs.gov
RIN: 0938-AO21
_______________________________________________________________________
1166. [bull] PART B MONTHLY ACTUARIAL RATES AND PREMIUM RATE BEGINNING
JANUARY 1, 2007 (CMS-8030-N)
Priority: Other Significant
Legal Authority: 42 USC 1395r; Social Security Act, section 1839; MMA,
section 629; MMA, section 811
CFR Citation: None
Legal Deadline: Final, Statutory, September 30, 2006.
Abstract: This notice announces the monthly actuarial rates for aged
(age 65 and over) and disabled (under age 65) enrollees in Part B of
Medicare for 2007. It also announces the monthly Part B premium to be
paid by all enrollees, and the Part B deductible, during 2007.
Timetable:
________________________________________________________________________
Action                            Date                      FR Cite
________________________________________________________________________
Final Action                    09/00/06
Regulatory Flexibility Analysis Required: No
Small Entities Affected: No
Government Levels Affected: None
Agency Contact: Suzanne Codespote, Division Director of Medicare and
Medicaid Cost Estimates Group, Department of Health and Human Services,
Centers for Medicare & Medicaid Services, Office of Actuary, Mailstop
N3-26-00, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-7737
Email: suzanne.codespote@cms.hhs.gov
RIN: 0938-AO23
_______________________________________________________________________
1167. [bull] PROSPECTIVE PAYMENT SYSTEM AND CONSOLIDATED BILLING FOR
SKILLED NURSING FACILITIES--UPDATE FOR FY 2007 (CMS-1530-N)
Priority: Economically Significant. Major under 5 USC 801.
Legal Authority: Social Security Act, sec 1888(e)
CFR Citation: 42 CFR 424
Legal Deadline: Other, Statutory, July 30, 2005, Notice must be
published before August 1, 2006.
Abstract: This notice updates the payment rates used under the SNF PPS
beginning 10/1/06.
Timetable:
________________________________________________________________________
Action                            Date                      FR Cite
________________________________________________________________________
Final Action                    07/00/06
Regulatory Flexibility Analysis Required: Undetermined
Government Levels Affected: Undetermined
Agency Contact: Bill Ullman, Health Insurance Specialist, Division of
Institutional Post Acute Care, Department of Health and Human Services,
Centers for Medicare & Medicaid Services, Chronic Care Policy Group,
Mailstop C5-07-08, 7500 Security Boulevard, Baltimore, MD 21244-1850
Phone: 410 786-5667
Email: bill.ullman@cms.hhs.gov
RIN: 0938-AO25
_______________________________________________________________________
1168. [bull] HOSPICE WAGE INDEX FOR FY 2007 (CMS-1535-N)
Priority: Other Significant
Legal Authority: 1824 (i)(2)(D) of the Act; 1814 (i)(1)(A); 1814
(i)(C)(ii)
CFR Citation: 42 CFR 418.306 (c)
Legal Deadline: Final, Statutory, September 1, 2006.
Abstract: This notice announces the annual update to the hospice wage
index for FY 2007. The wage index is used to reflect local differences
in wage levels. The hospice wage index methodology and values are based
on recommendations of a negotiated rulemaking advisory committee and
were originally published on 8/8/97.
Timetable:
________________________________________________________________________
Action                            Date                      FR Cite
________________________________________________________________________
Final Action                    08/00/06
Regulatory Flexibility Analysis Required: Undetermined
Small Entities Affected:  Businesses
Government Levels Affected: Undetermined
Federalism:  Undetermined
Agency Contact: Terri Deutsch, Health Insurance Specialist, Division of
Community Post Acute Care, Department of Health and Human Services,
Centers for Medicare & Medicaid Services, Hospital and Ambulatory
Policy Group, Mailstop C5-08-18, 7500 Security Boulevard, Baltimore, MD
21244-1850
Phone: 410 786-9462
Email: terri.deutsch@cms.hhs.gov
RIN: 0938-AO26
_______________________________________________________________________
Department of Health and Human Services (HHS)         Long-Term Actions
Centers for Medicare & Medicaid Services (CMS)
_______________________________________________________________________
1169. END STAGE RENAL DISEASE (ESRD) CONDITIONS FOR COVERAGE (CMS-3818-
F) (SECTION 610 REVIEW)
Priority: Other Significant
Legal Authority: 42 USC 1395rr et al
CFR Citation: 42 CFR 400; 42 CFR 405; 42 CFR 410; 42 CFR 412 to 414; 42
CFR 488; 42 CRR 494
Legal Deadline: Final, Statutory, February 4, 2008, MMA sec. 902.
Abstract: This final rule revises the requirements that end stage renal
disease (ESRD) facilities must meet to be certified under the Medicare
program.
Timetable:
________________________________________________________________________
Action                            Date                      FR Cite
________________________________________________________________________
NPRM                            02/04/05                     70 FR 6184
Final Action                    02/00/08
Regulatory Flexibility Analysis Required: Yes
Small Entities Affected: Businesses
Government Levels Affected: None
[[Page 64614]]
Agency Contact: Teresa Casey, Health Insurance Specialist, Department
of Health and Human Services, Centers for Medicare & Medicaid Services,
Clinical Standards Group, S3-02-01, 7500 Security Boulevard, Baltimore,
MD 21244
Phone: 410 786-7215
Email: mary.casey@cms.hhs.gov
Robert Miller, Health Insurance Specialist, Department of Health and
Human Services, Centers for Medicare & Medicaid Services, Clinical
Standards Group, Division of Non-Institutional Quality Standards, S3-
04-25, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-6797
Email: robert.miller@cms.hhs.gov
Rebecca Donnay, Health Insurance Specialist, Department of Health and
Human Services, Centers for Medicare & Medicaid Services, Clinical
Standards Group, Mailstop S3-02-01, 7500 Security Boulevard, Baltimore,
MD 21244
Phone: 410 786-1428
Email: rebecca.donnay@hhs.cms
RIN: 0938-AG82
_______________________________________________________________________
1170. HOSPITAL CONDITIONS OF PARTICIPATION: REQUIREMENTS FOR APPROVAL
AND RE-APPROVAL OF TRANSPLANT CENTERS TO PERFORM ORGAN TRANSPLANTS (CMS-
3835-F)
Priority: Other Significant
Legal Authority: 42 USC 1302; 42 USC 1395hh
CFR Citation: 42 USC 405; 42 USC 482; 42 USC 488
Legal Deadline: Final, Statutory, February 4, 2008, MMA sec. 902.
Abstract: This rule establishes conditions of participation for
Medicare-covered transplant centers.
Timetable:
________________________________________________________________________
Action                            Date                      FR Cite
________________________________________________________________________
NPRM                            02/04/05                     70 FR 6140
Final Action                    02/00/08
Regulatory Flexibility Analysis Required: No
Small Entities Affected: Businesses, Organizations
Government Levels Affected: None
Agency Contact: Eva Fung, Health Insurance Specialist, Department of
Health and Human Services, Centers for Medicare & Medicaid Services,
Clinical Standards Group, Mailstop S3-02-01, 7500 Security Boulevard,
Baltimore, MD 21244
Phone: 410 786-7539
Email: eva.fung@cms.hhs.gov
RIN: 0938-AH17
_______________________________________________________________________
1171. HOSPICE CARE--CONDITIONS OF PARTICIPATION (CMS-3844-F) (SECTION
610 REVIEW)
Priority: Other Significant
Legal Authority: 42 USC 1302; 42 USC 1395hh
CFR Citation: 42 CFR 418
Legal Deadline: Final, Statutory, May 27, 2008, MMA sec. 902.
Abstract: This final rule is a regulatory reform initiative that would
revise existing conditions of participation that hospices must meet to
participate in the Medicare and Medicaid programs. The proposed
requirements focus on the actual care delivered to patients and
patients' families by hospices and the results of that care, reflect an
interdisciplinary view of patient care, allow hospices greater
flexibility in meeting quality standards, and eliminate unnecessary
procedural requirements.
Timetable:
________________________________________________________________________
Action                            Date                      FR Cite
________________________________________________________________________
NPRM                            05/27/05                    70 FR 30840
Final Action                    05/00/08
Regulatory Flexibility Analysis Required: Undetermined
Small Entities Affected:  Businesses, Organizations
Government Levels Affected: None
Agency Contact: Mary Rossi-Coajou, Health Insurance Specialist,
Department of Health and Human Services, Centers for Medicare &
Medicaid Services, Clinical Standards Group, Mailstop S3-02-01, 7500
Security Boulevard, Baltimore, MD 21244
Phone: 410 786-6051
Email: mary .rossicoajou@cms.hhs.gov
RIN: 0938-AH27
_______________________________________________________________________
1172. 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: Final, Statutory, December 8, 2006, MMA sec. 202.
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: Local, State, 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,
Clinical Standards Group, Mailstop S3-02-01, 7500 Security Boulevard,
Baltimore, MD 21244
Phone: 410 786-1428
Email: rebecca.donnay@cms.hhs.gov
RIN: 0938-AJ10
_______________________________________________________________________
1173. STANDARDS FOR ELECTRONIC HEALTH CARE CLAIM ATTACHMENTS (CMS-0050-
P)
Priority: Economically Significant. Major under 5 USC 801.
Unfunded Mandates: This action may affect State, local or tribal
governments.
Legal Authority: 42 USC 1320d-2(a)(2)(B)
CFR Citation: 45 CFR 162
Legal Deadline: Final, Statutory, February 21, 1999.
Abstract: This rule finalizes an electronic standard for claims
[[Page 64615]]
attachments. The standard is required by the Health Insurance
Portability and Accountability Act of 1996. It will be used to transmit
clinical data, in addition to the data contained in the claims
standard, to help establish medical necessity for coverage and payment.
Timetable:
________________________________________________________________________
Action                            Date                      FR Cite
________________________________________________________________________
NPRM                            09/23/05                    70 FR 55989
Final Action                    09/00/08
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, Office of E-
Health Standards and Services, Department of Health and Human Services,
Centers for Medicare & Medicaid Services, Mailstop S-25-17, 7500
Security Boulevard, Baltimore, MD 21244
Phone: 410 786-6597
Email: lorraine.doo@cms.hhs.gov
RIN: 0938-AK62
_______________________________________________________________________
1174. PHYSICIANS' REFERRALS TO HEALTH CARE ENTITIES WITH WHICH THEY HAVE
FINANCIAL RELATIONSHIPS (CMS-1810-F)
Priority: Other Significant
Legal Authority: 42 USC 1877
CFR Citation: 42 CFR 411; 42 CFR 424
Legal Deadline: Final, Statutory, March 26, 2007, MMA sec. 902.
Abstract: This final rule incorporates into regulation certain
statutory provisions that preclude payment for services under Medicare
if a physician makes a referral to a facility in which he or she has a
financial interest. It addresses comments from the January 9, 1998
proposed rule concerning the ownership, investment, and compensation
exceptions. It also addresses comments from the January 4, 2001 final
rule with comment period.
Timetable:
________________________________________________________________________
Action                            Date                      FR Cite
________________________________________________________________________
Interim Final Rule              03/26/04                    69 FR 16054
Interim Final Rule Comment
Period End                      06/24/04
Correction Notice               04/06/04                    69 FR 17933
Second Correction Notice        09/24/04                    69 FR 57226
Final Action                    03/00/07
Regulatory Flexibility Analysis Required: Yes
Small Entities Affected: Businesses, Organizations
Government Levels Affected: None
Agency Contact: Linda P. Howard, Health Insurance Specialist,
Department of Health and Human Services, Centers for Medicare &
Medicaid Services, Center for Medicare Management, Chronic Care Policy
Group, Mailstop C4-25-02, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-5255
Email: linda.howard@cms.hhs.gov
RIN: 0938-AK67
_______________________________________________________________________
1175. 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: Final, Statutory, June 25, 2007, MMA sec. 902.
Abstract: This final rule redefines, clarifies, and updates the
guidelines and procedures for Provider Reimbursement Review Board
appeals, based on recent court decisions.
Timetable:
________________________________________________________________________
Action                            Date                      FR Cite
________________________________________________________________________
NPRM                            06/25/04                    69 FR 35716
NPRM Comment Period End         08/24/04
Final Action                    06/00/07
Regulatory Flexibility Analysis Required: No
Small Entities Affected: Businesses
Government Levels Affected: None
Agency Contact: Morton Marcus, Health Insurance Specialist, Department
of Health and Human Services, Centers for Medicare & Medicaid Services,
C4-25-02, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-4477
RIN: 0938-AL54
_______________________________________________________________________
1176. HEALTH COVERAGE PORTABILITY: TOLLING CERTAIN TIME PERIODS AND
INTERACTIONS WITH FAMILY AND MEDICAL LEAVE ACT (CMS-2158-F)
Priority: Other Significant
Legal Authority: 42 USC 300gg; PL 104-191
CFR Citation: 45 CFR 146.113; 45 CFR 146.115; 45 CFR 146.117; 45 CFR
146.120; 45 CFR 146.145
Legal Deadline: None
Abstract: This final rule will clarify certain portability requirements
for group health plans and issuers of health insurance coverage offered
in connection with a group health plan. It also implements changes made
to the Internal Revenue Code, the Employee Retirement Income Security
Act, and the Public Health Service Act enacted as part of the Health
Insurance Portability and Accountability Act of 1996.
Timetable:
________________________________________________________________________
Action                            Date                      FR Cite
________________________________________________________________________
NPRM                            12/30/04                    69 FR 78800
Final                           12/00/07
Regulatory Flexibility Analysis Required: No
Small Entities Affected: Businesses, Organizations
Government Levels Affected: Federal, Local, State
Federalism:  This action may have federalism implications as defined in
EO 13132.
Agency Contact: David Mlawsky, Health Insurance Specialist, Department
of Health and Human Services, Centers for Medicare & Medicaid Services,
Center for Beneficiary Choices, Medicare Plan Policy Group, Mailstop
S3-16-26, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-6851
Email: david.mlawsky@cms.hhs.gov
RIN: 0938-AL88
_______________________________________________________________________
1177. ELECTRONIC MEDICARE CLAIMS SUBMISSION (CMS-0008-F)
Priority: Other Significant
Legal Authority: PL 107-105
CFR Citation: Not Yet Determined
Legal Deadline: Final, Statutory, December 8, 2006, MMA sec. 902.
[[Page 64616]]
Abstract: This final rule implements the requirements for electronic
submission of Medicare claims, submitted on or after October 16, 2003.
In addition, this rule also implements the conditions upon which a
waiver could be granted for these requirements.
Timetable:
________________________________________________________________________
Action                            Date                      FR Cite
________________________________________________________________________
Interim Final Rule              08/15/03                    68 FR 48805
Interim Final Rule Comment
Period End                      10/16/03
Final Action                    12/00/06
Regulatory Flexibility Analysis Required: Undetermined
Government Levels Affected: None
Agency Contact: Stewart Streimer, Director, Provider Billing Group,
Department of Health and Human Services, Centers for Medicare &
Medicaid Services, C4-10-07, 7500 Security Boulevard, Baltimore, MD
21244
Phone: 410 786-9318
Email: stewart.streimer@cms.hhs.gov
RIN: 0938-AM22
_______________________________________________________________________
1178. 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: Final, Statutory, February 27, 2007, MMA sec. 902.
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
registered nurses, licensed practical nurses, licensed vocational
nurses, and certified nurse aides who are directly responsible for
resident care.
Timetable:
________________________________________________________________________
Action                            Date                      FR Cite
________________________________________________________________________
NPRM                            02/27/04                     69 FR 9282
NPRM Comment Period End         04/27/04
Final Action                    02/00/07
Regulatory Flexibility Analysis Required: No
Small Entities Affected: No
Government Levels Affected: None
Agency Contact: Anita Panicker, Health Insurance Specialist, Department
of Health and Human Services, Centers for Medicare & Medicaid Services,
Clinical Standards Group, S3-02-01, 7500 Security Boulevard, Baltimore,
MD 21244
Phone: 410 786-5646
Fax: 410 786-8532
Email: anita.panicker@cms.hhs.gov
RIN: 0938-AM55
_______________________________________________________________________
1179. REVISIONS TO THE APPEALS PROCESS FOR INITIAL CLAIM DETERMINATIONS
(CMS-4064-F)
Priority: Economically Significant. Major under 5 USC 801.
Legal Authority: Sec 521 of BIPA
CFR Citation: 42 CFR 401 and 405
Legal Deadline: Final, Statutory, June 30, 2008, MMA sec. 902.
Abstract: This final rule will revise the Medicare appeals process by
adding five levels of review. It will remove the distinction between
the processing of initial determinations and appeals under part A and
part B required by section 521 of Benefits Improvement and Protection
Act of 2000 (BIPA).
Timetable:
________________________________________________________________________
Action                            Date                      FR Cite
________________________________________________________________________
Interim Final Rule              03/08/05                    70 FR 11419
Interim Final Rule              06/30/05                    70 FR 37700
Final Action                    06/00/08
Regulatory Flexibility Analysis Required: No
Small Entities Affected: No
Government Levels Affected: Federal
Agency Contact: Arrah Tabe-Bedward, Health Insurance Specialist,
Department of Health and Human Services, Centers for Medicare &
Medicaid Services, Mailstop S1-05-06, 7500 Security Boulevard,
Baltimore, MD 21244-1850
Phone: 410 786-7129
Email: arrah.tabe-bedward@cms.hhs.gov
Related RIN: Related to 0938-AK69
RIN: 0938-AM73
_______________________________________________________________________
1180. CONDITIONS FOR COVERAGE OF POWER MOBILITY DEVICES, INCLUDING
POWERED WHEELCHAIRS AND POWER-OPERATED VEHICLES SCOOTER (CMS-3017-F)
Priority: Economically Significant. Major under 5 USC 801.
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: Final, Statutory, August 26, 2008, MMA sec. 902.
Abstract: This rule will make the requirements to purchase power
operated vehicles, functioning as wheelchairs, less stringent. It
expands who can order a Powered Operated Vehicle. It also requires a
face-to-face examination of the beneficiary before ordering a device.
Timetable:
________________________________________________________________________
Action                            Date                      FR Cite
________________________________________________________________________
Interim Final Rule              08/26/05                    70 FR 50939
Final Rule                      08/00/08
Regulatory Flexibility Analysis Required: No
Small Entities Affected: No
Government Levels Affected: None
Agency Contact: Karen Daily, Health Insurance Specialist Coverage &
Analysis Group, Department of Health and Human Services, Centers for
Medicare & Medicaid Services, Centers for Medicare and Medicaid
Services, Mailstop C1-09-06, 7500 Security Boulevard, Baltimore, MD
21244
Phone: 410 786-0189
Email: karen.daily@cms.hhs.gov
RIN: 0938-AM74
_______________________________________________________________________
1181. HOSPITAL CONDITIONS OF PARTICIPATION: REQUIREMENTS FOR HISTORY AND
PHYSICAL EXAMINATIONS; AUTHENTICATION OF VERBAL ORDERS; SECURING
MEDICATIONS; AND POST-ANESTHESIA EVALUATIONS (CMS-3122-F)
Priority: Other Significant
Legal Authority: 42 USC 1395x; 42 USC 1396d; 42 USC 1395bb
CFR Citation: 42 CFR 482
Legal Deadline: Final, Statutory, March 25, 2008, MMA sec. 902.
[[Page 64617]]
Abstract: This rule will reduce the burden on hospitals and allow
hospitals to conform to current standards of practice. Hospitals would
meet these final requirements to participate in Medicare and Medicaid.
They must establish and maintain policies and procedures that would
ensure their hospital would meet these requirements by using standard
practices for history and physical examinations, securing medications,
authenticating verbal orders, and completing post-anesthesia
evaluations.
Timetable:
________________________________________________________________________
Action                            Date                      FR Cite
________________________________________________________________________
NPRM                            03/25/05                    70 FR 15266
Final Action                    03/00/08
Regulatory Flexibility Analysis Required: Yes
Small Entities Affected: Organizations
Government Levels Affected: None
Additional Information: Decreases burden for hospitals and clinicians.
Agency Contact: Patricia Chmielewski, Health Insurance Specialist,
Department of Health and Human Services, Centers for Medicare &
Medicaid Services, Clinical Standards and Quality Group, Mailstop S3-
02-01, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-6899
Email: patricia.chmielewski@cms.hhs.gov
RIN: 0938-AM88
_______________________________________________________________________
1182. 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: 42 CFR 402
Legal Deadline: Final, Statutory, August 23, 2007, MMA sec. 902.
Abstract: This final rule proposes revisions to the CMS civil money
penalty authorities. These proposed revisions are intended to add the
specific exclusion sanction authorities as established in the
procedures for imposing civil money penalties, assessments, and
exclusions for certain violations of the Medicare and Medicaid
programs.
Timetable:
________________________________________________________________________
Action                            Date                      FR Cite
________________________________________________________________________
NPRM                            07/23/04                    69 FR 43956
Final Action                    07/00/07
Regulatory Flexibility Analysis Required: Undetermined
Government Levels Affected: Undetermined
Agency Contact: Joel Cohen, Health Insurance Specialist, Department of
Health and Human Services, Centers for Medicare & Medicaid Services,
Office of Financial Management, C3-04-06, 7500 Security Boulevard,
Baltimore, MD 21244-1850
Phone: 410 786-3349
RIN: 0938-AM98
_______________________________________________________________________
1183. PRIOR DETERMINATION PROCESS FOR CERTAIN ITEMS AND SERVICES (CMS-
6024-P)
Priority: Other Significant
Legal Authority: Sec 938 of the Medicare Modernization Act of 2003
CFR Citation: Not Yet Determined
Legal Deadline: Final, Statutory, June 8, 2005.
Abstract: Section 938 of the Medicare Modernization Act requires that
physicians and beneficiaries be able to receive a prior determination
regarding coverage of certain items and physicians' services (effective
June 8, 2005).
Timetable:
________________________________________________________________________
Action                            Date                      FR Cite
________________________________________________________________________
NPRM                            08/30/05                    70 FR 51321
Final Action                    08/00/08
Regulatory Flexibility Analysis Required: No
Small Entities Affected: No
Government Levels Affected: None
Agency Contact: Misty D. Whitaker, Health Insurance Specialist, Office
of Financial Management, Department of Health and Human Services,
Centers for Medicare & Medicaid Services, Program Integrity Group,
Office of Financial Management, Mail Stop C3-02-16, 7500 Security
Boulevard, Baltimore, MD 21244
Phone: 410 786-3087
Email: misty.whitaker@cms.hhs.gov
RIN: 0938-AN10
_______________________________________________________________________
1184. NONDISCRIMINATION IN HEALTH COVERAGE AND WELLNESS PLANS IN THE
GROUP MARKET (CMS-4081-F)
Priority: Substantive, Nonsignificant. Major status under 5 USC 801 is
undetermined.
Legal Authority: 42 USC 300gg
CFR Citation: 45 CFR 146.121
Legal Deadline: Final, Statutory, December 8, 2006, MMA sec. 902.
Abstract: This final rule governs the provisions prohibiting
discrimination based on a health factor for group health plans and
issuers of health insurance coverage offered in connection with a group
health plan. The rules contained in this document implement changes
made to the Internal Revenue Code of 1986 (Code), the Employee
Retirement Income Security Act of 1974, and the Public Health Service
Act enacted as part of the Health Insurance Portability and
Accountability Act of 1996. It also addresses comments we received on
the Bonafide Wellness Plan proposed rule (CMS-2078-P).
Timetable:
________________________________________________________________________
Action                            Date                      FR Cite
________________________________________________________________________
Interim Final Rule              04/08/97                    62 FR 16894
Interim Final Rule Comment
Period End                      07/17/97
Interim Final Rule Effective    07/17/97
Interim Final Rule              01/08/01                     66 FR 1378
Interim Final Rule Effective    03/09/01
Interim Final Rule Comment
Period End                      04/09/01
Final Action                    12/00/06
Regulatory Flexibility Analysis Required: No
Small Entities Affected: Businesses, Governmental Jurisdictions
Government Levels Affected: Local, State
Agency Contact: David Mlawsky, Health Insurance Specialist, Department
of Health and Human Services, Centers for Medicare & Medicaid Services,
Center for Beneficiary Choices, Medicare Plan Policy Group, S3-16-26,
7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-6851
Email: dmlawsky@cms.hhs.gov
RIN: 0938-AN29
[[Page 64618]]
_______________________________________________________________________
1185. 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: Final, Statutory, December 8, 2006, MMA sec. 902.
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: Janice Graham, Health Insurance Specialist, Department
of Health and Human Services, Centers for Medicare & Medicaid Services,
Office of Clinical Standards and Quality, Mailstop S3-05-27, 7500
Security Boulevard, Baltimore, MD 21244
Phone: 410 786-8020
Email: janice.graham@cms.hhs.gov
RIN: 0938-AN30
_______________________________________________________________________
1186. FEDERAL ENFORCEMENT IN GROUP AND INDIVIDUAL HEALTH INSURANCE
MARKETS (CMS-4091-F)
Priority: Other Significant
Legal Authority: 42 USC 300gg-22; 42 USC 300gg-31
CFR Citation: 45 CFR 150.101 to 150.465
Legal Deadline: None
Abstract: This rule finalizes, without any substantive changes, an
interim final regulation (HCFA-2019-IFC) that sets forth the process by
which CMS enforces the HIPAA title I requirements with regard to State
and local governmental group health plans. It also finalizes the
process by which CMS assumes direct enforcement responsibility in a
State with regard to group and individual market health insurance
issues.
Timetable:
________________________________________________________________________
Action                            Date                      FR Cite
________________________________________________________________________
Interim Final Rule              08/20/99                     64 FR 1999
Final Action                    12/00/06
Regulatory Flexibility Analysis Required: No
Small Entities Affected: No
Government Levels Affected: Local, State
Agency Contact: David Mlawsky, Health Insurance Specialist, Department
of Health and Human Services, Centers for Medicare & Medicaid Services,
Center for Beneficiary Choices, Medicare Plan Policy Group, Mailstop
S3-16-26, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-6851
Email: david.mlawsky@cms.hhs.gov
RIN: 0938-AN35
_______________________________________________________________________
1187. FIRE SAFETY REQUIREMENTS FOR CERTAIN HEALTH CARE FACILITIES;
ALCOHOL-BASED HAND SANITIZER AMENDMENT (CMS-3145-F)
Priority: Other Significant
Legal Authority: Not Yet Determined
CFR Citation: 42 CFR 403; 42 CFR 416; 42 CFR 418; 42 CFR 460; 42 CFR
482; 42 CFR 483; 42 CFR 485
Legal Deadline: Final, Statutory, March 25, 2008, MMA sec. 902.
Abstract: This final rule amends the fire safety standard for religious
nonmedical health care institutions, hospices, programs of all-
inclusive care for the elderly, hospitals, long-term care facilities,
intermediate care facilities for the mentally retarded, and critical
access hospitals that participate in Medicare and Medicaid. The rule
adopts a change made to the 2000 edition of the Life Safety Code (LSC)
published by the National Fire Protection Association (NFPA). We
adopted the 2000 edition of the LSC in January 2003. The LSC change
will allow facilities to place alcohol-based hand sanitizer dispensers
in exit corridors under certain conditions. These sanitizers have
proven to be effective in increasing hand hygiene and have the
potential to improve infection control practice. Adopting the LSC
change will increase a provider's flexibility in meeting infection
control goals while minimizing potential fire safety concerns.
Additionally, this rule includes a requirement for placement of battery
operated smoke alarms in resident rooms in non-sprinkled SNFs.
Timetable:
________________________________________________________________________
Action                            Date                      FR Cite
________________________________________________________________________
Interim Final Rule With Comments03/25/05                    70 FR 15229
Final Action                    03/00/08
Regulatory Flexibility Analysis Required: No
Small Entities Affected: No
Government Levels Affected: None
Additional Information: Providers requesting publication of this
regulation.
Agency Contact: Danielle Shearer, Health Insurance Specialist,
Department of Health and Human Services, Centers for Medicare &
Medicaid Services, Clinical Standards Group,, Mailstop S3-02-01, 7500
Security Boulevard, Baltimore, MD 21244
Phone: 410 786-6617
Email: danielle.shearer@cms.hhs.gov
RIN: 0938-AN36
_______________________________________________________________________
1188. REVISED CIVIL MONEY PENALTIES, ASSESSMENTS, EXCLUSIONS, AND
RELATED APPEALS PROCEDURES (CMS-6019-F)
Priority: Other Significant
Legal Authority: PL 108-173, sec 949 of MMA
CFR Citation: 42 CFR 402.400
Legal Deadline: Final, Statutory, December 8, 2003.
Abstract: Section 949 of the Medicare Modernization Act changed the
designation of authority to request waiver of a program exclusion under
the Social Security Act from the State to the Administrator of a
Federal health
[[Page 64619]]
care program. This rule proposes to outline a process for health care
providers to follow if they wish CMS to request a waiver of exclusion
on their behalf (effective December 8, 2003).
Timetable:
________________________________________________________________________
Action                            Date                      FR Cite
________________________________________________________________________
NPRM                            08/04/05                    70 FR 44879
Final Action                    08/00/08
Regulatory Flexibility Analysis Required: No
Small Entities Affected: No
Government Levels Affected: None
Agency Contact: Joel Cohen, Health Insurance Specialist, Department of
Health and Human Services, Centers for Medicare & Medicaid Services,
Office of Financial Management, Program Integrity Group, 7500 Security
Boulevard, Baltimore, MD 21244
Phone: 410 786-3349
Email: jcohen@cms.hhs.gov
Related RIN: Merged with 0938-AM98
RIN: 0938-AN48
_______________________________________________________________________
1189. ELECTRONIC PRESCRIBING STANDARDS (CMS-0011-F)
Priority: Economically Significant. Major under 5 USC 801.
Legal Authority: 42 USC 1395
CFR Citation: None
Legal Deadline: Final, Statutory, September 1, 2005, Required e-
prescribing before outset of January 1, 2006, Medicare part D drug
benefit.
Abstract: This final rule requires Medicare part D plans and Medicare
Advantage Plans to support electronic transmission of basic
prescription data to, and from, doctors and pharmacies, and to adopt a
number of the initial standards required for electronic prescribing by
section 1860(d) of the Medicare Modernization Act.
Timetable:
________________________________________________________________________
Action                            Date                      FR Cite
________________________________________________________________________
NPRM                            02/04/05                     70 FR 6255
Final Action                    02/00/08
Regulatory Flexibility Analysis Required: No
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: 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
_______________________________________________________________________
1190. MEDICARE PART B COMPETITIVE ACQUISITION OF OUTPATIENT DRUGS AND
BIOLOGICALS (CMS-1325-F)
Priority: Economically Significant. Major under 5 USC 801.
Legal Authority: MMA of 2003, sec 303(d)
CFR Citation: 42 CFR 414
Legal Deadline: Final, Statutory, January 1, 2006, MMA of 2003, section
303(d) or section 1847(B)(a)(1) of the Social Security Act.
Abstract: Section 303(d) of the Medicare Modernization Act requires the
implementation of a competitive bidding program for Medicare part B
drugs not paid on a cost or prospective payment system basis. Beginning
January 1, 2006, physicians will be given a choice between purchasing
these drugs and being paid by Medicare under the average sales price
(ASP) system, or obtaining these drugs from vendors selected in a
competitive bidding process. If the physician elects to obtain drugs
from a competitive vendor, the vendor will bill Medicare for the drug.
Timetable:
________________________________________________________________________
Action                            Date                      FR Cite
________________________________________________________________________
NPRM                            03/04/05                    70 FR 10745
Interim Final Rule              07/06/05                    70 FR 39022
Final Action                    07/00/08
Regulatory Flexibility Analysis Required: Yes
Small Entities Affected: Businesses
Government Levels Affected: None
Agency Contact: Edmund E. Kasaitis, Health Insurance Specialist,
Hospital & Ambulatory Policy Group, Department of Health and Human
Services, Centers for Medicare & Medicaid Services, Mailstop C4-01-26,
7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-0477
Email: edmund.kasaitis@cms.hhs.gov
RIN: 0938-AN58
_______________________________________________________________________
1191. GROUP MARKET HEALTH INSURANCE REFORM: GUARANTEED AVAILABILITY,
GUARANTEED RENEWABILITY, DISCLOSURES TO SMALL EMPLOYERS (CMS-4102-F)
Priority: Other Significant. Major status under 5 USC 801 is
undetermined.
Legal Authority: 42 USC 300gg-92
CFR Citation: 45 CFR 146.150; 45 CFR 146.152; 45 CFR 146.160
Legal Deadline: Final, Statutory, December 8, 2006, MMA sec. 902.
Abstract: This regulation finalizes the interim final regulation (BPD-
890-IFC) guaranteeing the availability of health insurance coverage to
small employers, and guaranteeing the renewability of health insurance
coverage to small and large employers.
Timetable:
________________________________________________________________________
Action                            Date                      FR Cite
________________________________________________________________________
Final Action                    12/00/06
Regulatory Flexibility Analysis Required: No
Small Entities Affected: No
Government Levels Affected: None
Agency Contact: David R. Mlawsky, Health Insurance Specialist, Center
for Beneficiary Choices, Department of Health and Human Services,
Centers for Medicare & Medicaid Services, Medicare Plan Policy Group,
Mailstop S3-16-26, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 877 267-2323
Email: david.mlawsky@cms.hhs.gov
Related RIN: Related to 0938-AI08
RIN: 0938-AN60
_______________________________________________________________________
1192. INDIVIDUAL MARKET HEALTH INSURANCE REFORM: PORTABILITY FROM GROUP
TO INDIVIDUAL COVERAGE; FEDERAL RULES FOR ACCESS IN THE INDIVIDUAL
MARKET; STATE ALTERNATIVE MECHANISMS TO FEDERAL RULES (CMS-4103-F)
Priority: Other Significant. Major under 5 USC 801.
Legal Authority: 42 USC 300gg-92
CFR Citation: 42 CFR 148.11; 42 CFR 148.102; 42 CFR 148.103; 42 CFR
148.122; 42 CFR 148.1
Legal Deadline: Final, Statutory, December 8, 2006, MMA sec. 902.
Abstract: This regulation finalizes the interim final rule (BPD-890-
IFC) that
[[Page 64620]]
guarantees availability of health coverage to certain individuals,
guarantees renewability of coverage in the individual market, and sets
standards for State alternative mechanisms for guaranteeing coverage to
certain individuals.
Timetable:
________________________________________________________________________
Action                            Date                      FR Cite
________________________________________________________________________
Final Action                    12/00/06
Regulatory Flexibility Analysis Required: No
Small Entities Affected: No
Government Levels Affected: None
Agency Contact: David R. Mlawsky, Health Insurance Specialist,
Department of Health and Human Services, Centers for Medicare &
Medicaid Services, Center for Beneficiary Choices, Medicare Plan Policy
Group, Mailstop S3-16-16, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 877 267-2323
Email: david.mlawsky@cms.hhs.gov
Related RIN: Related to 0938-AI08
RIN: 0938-AN61
_______________________________________________________________________
1193. MEDICARE INTEGRITY PROGRAM, FISCAL INTERMEDIARY AND CARRIER
FUNCTIONS, AND CONFLICT OF INTEREST REQUIREMENTS (CMS-6030-F)
Priority: Other Significant
Legal Authority: Sec 902 of the MMA
CFR Citation: Not Yet Determined
Legal Deadline: Final, Statutory, June 17, 2008, MMA sec. 902.
Abstract: This rule finalizes certain sections of the Medicare
regulations concerning fiscal intermediaries and carriers and brings
them into conformity with the Medicare statute. The rule would
distinguish between those functions that the statute requires to be
included in agreements with fiscal intermediaries and those that may be
included in the agreements. It would also provide that some or all of
the functions may be included in carrier contracts. Currently all these
functions are mandatory for carrier contracts.
Timetable:
________________________________________________________________________
Action                            Date                      FR Cite
________________________________________________________________________
NPRM                            06/17/05                    70 FR 35204
Final Action                    06/00/08
Regulatory Flexibility Analysis Required: No
Small Entities Affected: Businesses
Government Levels Affected: None
Agency Contact: Lauren Haley, Health Insurance Specialist, Department
of Health and Human Services, Centers for Medicare & Medicaid Services,
Centers for Medicare and Medicaid Services, Mailstop C3-02-16, 7500
Security Boulevard, Baltimore, MD 21244-1850
Phone: 410 786-1730
Email: lauren.haley@cms.hhs.gov
Related RIN: Related to 0938-AI09
RIN: 0938-AN72
_______________________________________________________________________
1194. APPLICATION OF INHERENT REASONABLENESS TO ALL MEDICARE PART B
SERVICES (OTHER THAN PHYSICIAN SERVICES) (CMS-1908-F)
Priority: Info./Admin./Other. Major status under 5 USC 801 is
undetermined.
Legal Authority: BBA; BBRA
CFR Citation: 42 CFR 405
Legal Deadline: Final, Statutory, December 8, 2006, MMA sec. 902.
Abstract: This rule finalizes the December 13, 2002, interim final rule
and sets forth the process for establishing realistic and equitable
payment amounts for all Medicare part B items and services (other than
physician services) when the existing payment amounts are inherently
unreasonable because they are either grossly excessive or grossly
deficient. The rule describes the factors CMS (or its carriers) will
consider, and the procedures that will be followed in establishing
realistic and equitable payment amounts. This rule implements section
4316 of the BBA, and section 223 of the BBRA that required CMS to
publish this subsequent final rule.
Timetable:
________________________________________________________________________
Action                            Date                      FR Cite
________________________________________________________________________
Interim Final Rule              12/13/02                    67 FR 76684
Interim Final Rule Comment
Period End                      02/11/03
Final Rule                      12/00/06
Regulatory Flexibility Analysis Required: No
Small Entities Affected: Businesses
Government Levels Affected: None
Agency Contact: Bill Long, Health Insurance Specialist, Department of
Health and Human Services, Centers for Medicare & Medicaid Services,
Center for Medicare Management, Mailstop C5-08-27, 7500 Security
Boulevard, Baltimore, MD 21244
Phone: 410 786-5655
Email: bill.long@cms.hhs.gov
RIN: 0938-AN81
_______________________________________________________________________
1195. PROGRAM FOR ALL-INCLUSIVE CARE FOR THE ELDERLY (PACE): PROGRAM
REVISIONS (CMS-1201-F)
Priority: Other Significant
Legal Authority: PL 108-173, sec 902 of MMA; BIPA, sec 903
CFR Citation: 42 CFR 460
Legal Deadline: Final, Statutory, December 8, 2006, MMA sec. 902.
Abstract: This rule finalizes two interim final rules with comment
periods. The November 24, 1999, rule established requirements for
Programs of All-inclusive Care for the Elderly (PACE) under the
Medicare and Medicaid programs and the October 1, 2002, rule that
implemented section 903 of BIPA. These are pre-paid, capitated programs
for beneficiaries who meet special eligibility requirements and who
elect to enroll.
Timetable:
________________________________________________________________________
Action                            Date                      FR Cite
________________________________________________________________________
Interim Final Rule              11/24/99                    64 FR 66234
Interim Final Rule              10/01/02                    67 FR 61496
Final Action                    12/00/06
Regulatory Flexibility Analysis Required: No
Small Entities Affected: Businesses, Governmental Jurisdictions,
Organizations
Government Levels Affected: Federal, Local, State, Tribal
Federalism:  Undetermined
Agency Contact: Janet Harris, Health Insurance Specialist, Department
of Health and Human Services, Centers for Medicare & Medicaid Services,
Center for Medicare Management, Chronic Care Policy Group, Mailstop C5-
05-27, 7500 Security Boulevard, Baltimore, MD 21244-1850
Phone: 410 786-3137
Email: janet.harris@cms.hhs.gov
Related RIN: Previously reported as 0938-AL59
RIN: 0938-AN83
[[Page 64621]]
_______________________________________________________________________
1196. ELECTRONIC SUBMISSION OF COST REPORTS: REVISION TO COST REPORTING
PERIOD (CMS-1199-F)
Priority: Substantive, Nonsignificant
Legal Authority: None
CFR Citation: None
Legal Deadline: Final, Statutory, May 27, 2008, MMA sec. 902.
Abstract: This final rule follows a August 26, 2003, final rule that
requires ESRD facilities, hospices, rural health clinics, federally
qualified health centers, and community mental health centers to file
cost reports in a standardized electronic format. It provided a delay
or waiver of this requirement if implementation would result in
financial hardship. Because the software packages for accepting the
cost reports are not available yet, this final rule changes the cost
report ending date from December 31, 2004, to March 31, 2005.
Timetable:
________________________________________________________________________
Action                            Date                      FR Cite
________________________________________________________________________
Interim Final Rule              05/27/05                    70 FR 30640
Final Action                    05/00/08
Regulatory Flexibility Analysis Required: No
Small Entities Affected: Businesses
Government Levels Affected: None
Agency Contact: Darryl E. Simms, Health Insurance Specialist,
Department of Health and Human Services, Centers for Medicare &
Medicaid Services, C5-03-30, 7500 Security Boulevard, Baltimore, MD
21244
Phone: 410 786-4524
Email: dsimms@cms.hhs.gov
Related RIN: Related to 0938-AL51
RIN: 0938-AN87
_______________________________________________________________________
1197. [bull] LOAN FORGIVENESS CRITERIA FOR THE HEALTH CARE
INFRASTRUCTURE LOAN PROGRAM (CMS-1320-F)
Priority: Other Significant
Legal Authority: sec 1016 of PL 108-173
CFR Citation: 42 CFR 505
Legal Deadline: NPRM, Statutory, July 1, 2004.
Abstract: The Secretary is authorized to forgive such loans awarded in
the Health Care Infrastructure Improvement Program if the hospital
establishes an outreach program for cancer prevention, early diagnosis,
and treatment for a substantial majority of the residents of the state,
a similar program for multiple Indian tribes, and either unique
research resources or an affiliation with an entity that has unique
research resources.
Timetable:
________________________________________________________________________
Action                            Date                      FR Cite
________________________________________________________________________
NPRM                            09/30/05                    70 FR 57376
Final Action                    09/00/08
Regulatory Flexibility Analysis Required: Undetermined
Small Entities Affected:  Businesses
Government Levels Affected: None
Agency Contact: Tzvi Hefter, Director of the Division of Acute Care,
Department of Health and Human Services, Centers for Medicare &
Medicaid Services, Hospital and Ambulatory Policy Group, Mailstop C4-
01-17, 7500 Security Boulevard, Baltimore, MD 21244-1850
Phone: 410 786-4487
Email: tzvi.hefter@cms.hhs.gov
RIN: 0938-AN93
_______________________________________________________________________
1198. [bull] HEALTH CARE INFRASTRUCTURE IMPROVEMENT PROGRAM; SELECTION
CRITERIA OF LOAN PROGRAM FOR QUALIFYING HOSPITALS ENGAGED IN CANCER-
RELATED HEALTH CARE (CMS-1287-F)
Priority: Economically Significant. Major under 5 USC 801.
Legal Authority: Section 1016 of Public Law 108-173
CFR Citation: 42 CFR 505
Legal Deadline: Final, Statutory, July 1, 2004.
Abstract: This rule would establish a loan program to improve certain
hospital infrastructure, including capital improvement. To receive
assistance, the applicant would be required to: 1) Engage in cancer
research; and 2) be designated by the National Cancer Institute (NCI)
as a cancer center or by the State as the official cancer institute. No
later than 4 years after enactment, the Secretary must submit a report
to Congress summarizing the financial performance of the projects that
have received assistance under the loan program.
Timetable:
________________________________________________________________________
Action                            Date                      FR Cite
________________________________________________________________________
Interim Final Rule              09/30/05                    70 FR 57368
Final Action                    09/00/08
Regulatory Flexibility Analysis Required: Undetermined
Small Entities Affected:  Businesses
Government Levels Affected: None
Agency Contact: Melinda Jones, Health Insurance Specialist, Quality
Measurement & Health Assessment Group, Department of Health and Human
Services, Centers for Medicare & Medicaid Services, Mailstop S3-02-01,
7500 Security Boulevard, Baltimore, MD 21244-1850
Phone: 410 786-7069
Email: melinda.jones@cms.hhs.gov
Tzvi Hefter, Director of the Division of Acute Care, Department of
Health and Human Services, Centers for Medicare & Medicaid Services,
Mailstop C4-01-17, 7500 Security Boulevard, Baltimore, MD 21244-1850
Phone: 410 786-4487
Email: tzvi.hefter@cms.hhs.gov
Related RIN: Related to 0938-AN93
RIN: 0938-AO03
_______________________________________________________________________
1199. [bull] MEDICAL IMPROVEMENT ELIGIBILITY GROUP AND DEFINITION OF
WORK (CMS-2143-P)
Priority: Other Significant
Legal Authority: PL 105-33 sec 4733 Balanced Budget Act of 1997; PL
106-170 sec 201 Ticket to Work and Work Incentives Improvement Act of
1999
CFR Citation: 42 CFR 435 238; 42 CFR 436-232
Legal Deadline: None
Abstract: In order to provide health services to employed individuals
whose medical conditions have improved to the point where they are no
longer eligible for disability benefits, this proposed rule would
provide a definition of ``medically determinable severe impairment''
under the Ticket to Work and Work Incentives Improvement Act of 1999
(Ticket to Work). Under this definition, States can determine
eligibility standards for the Medical Improvement Group authorized
under the Ticket to Work law, thereby permitting individuals to retain
their Medicaid coverage. Additionally, this proposed rule would
[[Page 64622]]
give States offering Medicaid buy-in programs for employed individuals
with disabilities the option of selecting a minimum work standard for
participation.
Timetable:
________________________________________________________________________
Action                            Date                      FR Cite
________________________________________________________________________
NPRM                            10/00/06
Regulatory Flexibility Analysis Required: No
Small Entities Affected: No
Government Levels Affected: State
Agency Contact: Carey Appold, Technical Director, Disabled & Elderly
Health Programs Group, Div. of Advocacy and Special Issues, Department
of Health and Human Services, Centers for Medicare & Medicaid Services,
Center for Medicaid and State Operations, Mailstop S2-14-26, 7500
Security Boulevard, Baltimore, MD 21244-1850
Phone: 410 786-2117
Fax: 410 786-9004
Email: carey.appold@cms.hhs.gov
RIN: 0938-AO10
_______________________________________________________________________
Department of Health and Human Services (HHS)         Completed Actions
Centers for Medicare & Medicaid Services (CMS)
_______________________________________________________________________
1200. SUPPLIER STANDARDS FOR HOME OXYGEN, THERAPEUTIC SHOES, AND HOME
NUTRITION THERAPY (CMS-6010-P)
Priority: Substantive, Nonsignificant
CFR Citation: 42 CFR 424.57
Completed:
________________________________________________________________________
Reason                            Date                      FR Cite
________________________________________________________________________
Withdrawn                       06/28/05
Regulatory Flexibility Analysis Required: Yes
Small Entities Affected: Businesses
Government Levels Affected: None
Agency Contact: Ralph Goldberg
Phone: 410 786-4870
RIN: 0938-AJ98
_______________________________________________________________________
1201. EVALUATION CRITERIA AND STANDARDS FOR QUALITY IMPROVEMENT PROGRAM
CONTRACTS (CMS-3142-FN)
Priority: Info./Admin./Other
CFR Citation: None
Completed:
________________________________________________________________________
Reason                            Date                      FR Cite
________________________________________________________________________
Final Action                    07/22/05                    70 FR 42331
Regulatory Flexibility Analysis Required: No
Small Entities Affected: No
Government Levels Affected: None
Agency Contact: Maria L. Hammel
Phone: 410 786-1775
Email: maria.hammel@cms.hhs.gov
RIN: 0938-AN13
_______________________________________________________________________
1202. NONDISCRIMINATION IN POST-HOSPITAL REFERRAL TO HOME HEALTH
AGENCIES AND OTHER ENTITIES (CMS-1224-F)
Priority: Substantive, Nonsignificant
CFR Citation: 42 CFR 482
Completed:
________________________________________________________________________
Reason                            Date                      FR Cite
________________________________________________________________________
Withdrawn                       08/15/05
Regulatory Flexibility Analysis Required: No
Small Entities Affected: No
Government Levels Affected: None
Agency Contact: Sarah Shipey
Phone: 410 786-0187
RIN: 0938-AN19
_______________________________________________________________________
1203. MEDICARE AMBULANCE FEE SCHEDULE UPDATE (CMS-1492-IFC)
Priority: Other Significant
CFR Citation: 42 CFR 414, subpart H
Completed:
________________________________________________________________________
Reason                            Date                      FR Cite
________________________________________________________________________
Withdrawn                       08/29/05
Regulatory Flexibility Analysis Required: Yes
Small Entities Affected: Businesses
Government Levels Affected: Local
Agency Contact: Robert Niemann
Phone: 410 786-4596
Email: rnieman@cms.hhs.gov
Related RIN: Related to 0938-AO11
RIN: 0938-AN24
_______________________________________________________________________
1204. PROSPECTIVE PAYMENT SYSTEM FOR LONG TERM CARE HOSPITALS: ANNUAL
PAYMENT RATE UPDATES AND POLICY CHANGES FOR 2006 (CMS-1483-F)
Priority: Economically Significant. Major under 5 USC 801.
CFR Citation: None
Completed:
________________________________________________________________________
Reason                            Date                      FR Cite
________________________________________________________________________
Final Action                    05/06/05                    70 FR 24168
Regulatory Flexibility Analysis Required: Yes
Small Entities Affected: Businesses
Government Levels Affected: None
Agency Contact: Judy Richter
Phone: 410 786-2590
Email: jrichter@cms.hhs.gov
RIN: 0938-AN28
_______________________________________________________________________
1205. PROSPECTIVE PAYMENT SYSTEM FOR INPATIENT REHABILITATION FACILITIES
FOR FY 2006 (CMS-1290-F)
Priority: Economically Significant. Major under 5 USC 801.
CFR Citation: None
Completed:
________________________________________________________________________
Reason                            Date                      FR Cite
________________________________________________________________________
NPRM                            05/25/05                    70 FR 30187
Final Action                    08/15/05                    70 FR 47879
Regulatory Flexibility Analysis Required: No
Small Entities Affected: Businesses
Government Levels Affected: None
Agency Contact: Robert Kuhl
Phone: 410 786-4597
Email: bob.kuhl@cms.hhs.gov
RIN: 0938-AN43
[[Page 64623]]
_______________________________________________________________________
1206. DEVELOPMENT OF NEW STANDARDS FOR MEDIGAP POLICIES (CMS-4087-FN)
Priority: Substantive, Nonsignificant
CFR Citation: None
Completed:
________________________________________________________________________
Reason                            Date                      FR Cite
________________________________________________________________________
Withdrawn                       05/27/05
Regulatory Flexibility Analysis Required: No
Small Entities Affected: No
Government Levels Affected: None
Agency Contact: Julie Walton
Phone: 410 786-4622
Email: jwalton@cms.hhs.gov
Related RIN: Related to 0938-AN08
RIN: 0938-AN50
_______________________________________________________________________
1207. FISCAL YEAR 2006 SCHIP ALLOTMENTS (CMS-2219-N)
Priority: Other Significant
CFR Citation: 42 CFR 457
Completed:
________________________________________________________________________
Reason                            Date                      FR Cite
________________________________________________________________________
Notice                          06/24/05                    70 FR 36615
Regulatory Flexibility Analysis Required: No
Small Entities Affected: No
Government Levels Affected: State
Agency Contact: Richard Strauss
Phone: 410 786-2019
Email: richard.strauss@cms.hhs.gov
RIN: 0938-AN56
_______________________________________________________________________
1208. CHANGES TO THE HOSPITAL INPATIENT PROSPECTIVE PAYMENT SYSTEM AND
FY 2006 RATES (CMS-1500-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                            05/04/05                    70 FR 23306
Final Action                    08/12/05                    70 FR 47277
Regulatory Flexibility Analysis Required: Yes
Small Entities Affected: Businesses
Government Levels Affected: Federal
Agency Contact: Marc Hartstein
Phone: 410 786-6192
Email: marc.hartstein@cms.hhs.gov
RIN: 0938-AN57
_______________________________________________________________________
1209. SPECIAL PAYMENT PROVISIONS AND STANDARDS FOR SUPPLIERS OF CUSTOM
FABRICATED ORTHOTICS AND PROSTHETICS (CMS-6012-P)
Priority: Economically Significant. Major under 5 USC 801.
CFR Citation: 42 CFR 410; 42 CFR 414; 42 CFR 424
Completed:
________________________________________________________________________
Reason                            Date                      FR Cite
________________________________________________________________________
Withdrawn                       06/28/05
Regulatory Flexibility Analysis Required: Yes
Small Entities Affected: Businesses
Government Levels Affected: None
Agency Contact: Theresa Linkowich
Phone: 410 786-9249
Email: tlinkowich@cms.hhs.gov
Ralph Goldberg
Phone: 410 786-8864
RIN: 0938-AN63
_______________________________________________________________________
1210. PROSPECTIVE PAYMENT SYSTEM AND CONSOLIDATED BILLING FOR SKILLED
NURSING FACILITIES--UPDATE FOR FY 2006 (CMS-1282-F)
Priority: Economically Significant. Major under 5 USC 801.
CFR Citation: 42 CFR 409; 42 CFR 411; 42 CFR 424; 42 CFR 489
Completed:
________________________________________________________________________
Reason                            Date                      FR Cite
________________________________________________________________________
NPRM                            05/19/05                    70 FR 29069
Final Action                    08/04/05                    70 FR 45025
Regulatory Flexibility Analysis Required: No
Small Entities Affected: Businesses, Organizations
Government Levels Affected: None
Agency Contact: Bill Ullman
Phone: 401 786-5667
Email: bill.ullman@cms.hhs.gov
RIN: 0938-AN65
_______________________________________________________________________
1211. STATE CHILDREN'S HEALTH INSURANCE PROGRAM (SCHIP); REDISTRIBUTION
OF UNEXPENDED SCHIP FUNDS FROM THE APPROPRIATION FOR FISCAL YEAR (FY)
2002 (CMS-2230-FN)
Priority: Other Significant
CFR Citation: 42 CFR 457.600 to 457.630
Completed:
________________________________________________________________________
Reason                            Date                      FR Cite
________________________________________________________________________
Final Action                    09/29/05                    70 FR 56901
Regulatory Flexibility Analysis Required: No
Small Entities Affected: No
Government Levels Affected: State
Agency Contact: Richard Strauss
Phone: 410 786-2019
Email: richard.strauss@cms.hhs.gov
RIN: 0938-AN78
_______________________________________________________________________
1212. EXTENDING SUNSET DATE FOR THE INTERIM FINAL REGULATION ON MENTAL
HEALTH PARITY (CMS-4094-F3)
Priority: Other Significant
CFR Citation: 42 CFR 146
Completed:
________________________________________________________________________
Reason                            Date                      FR Cite
________________________________________________________________________
Final Action                    07/22/05                    70 FR 42276
Regulatory Flexibility Analysis Required: No
Small Entities Affected: No
Government Levels Affected: None
Agency Contact: David Mlawsky
Phone: 410 786-6851
Email: david.mlawsky@cms.hhs.gov
Related RIN: Related to 0938-AN22
RIN: 0938-AN80
_______________________________________________________________________
1213. [bull] DISPROPORTIONATE SHARE HOSPITAL PAYMENTS--INSTITUTIONS FOR
MENTAL DISEASE (IMDS) (CMS-2062-N2)
Timetable:
________________________________________________________________________
Action                            Date                      FR Cite
________________________________________________________________________
Duplicate of 0938-AN96          05/24/05
RIN: 0938-AN88
[[Page 64624]]
_______________________________________________________________________
1214. [bull] HOSPICE WAGE INDEX FOR FY 2006 (CMS-1286-F)
Priority: Other Significant
Legal Authority: Sec. 408 and 946 of the MMA of 2003;; Sec. 1861(dd) of
the Social Security Act
CFR Citation: 42 CFR 418.306c
Legal Deadline: Final, None, August 2005, Rates are updated October 1st
of each year-need at least 3 months to implement.
Abstract: This rule announces the annual update to the hospice wage
index for FY 2006. The wage index is used to reflect local differences
in wage levels. The hospice wage index methodology and values are based
on recommendations of a negotiated rulemaking advisory committee and
were originally published on 8/8/97.
Timetable:
________________________________________________________________________
Action                            Date                      FR Cite
________________________________________________________________________
NPRM                            04/29/05                    70 FR 22393
Final Action                    08/04/05                    70 FR 45129
Regulatory Flexibility Analysis Required: No
Small Entities Affected: Businesses
Government Levels Affected: None
Agency Contact: Terri Deutsch, Health Insurance Specialist, Division of
Community Post Acute Care, Department of Health and Human Services,
Centers for Medicare & Medicaid Services, Hospital and Ambulatory
Policy Group, Mailstop C5-08-28, 7500 Security Boulevard, Baltimore, MD
21244
Phone: 410 786-9462
Email: terri.deutsch@cms.hhs.gov
RIN: 0938-AN89
_______________________________________________________________________
1215. [bull] INPATIENT REHABILITATION FACILITY CLASSIFICATION RULE
COMPLIANCE (CMS-1480-N)
Priority: Other Significant
Legal Authority: Public Law 108-477, In accordance with the
Consolidated Appropriations Act of 2005
CFR Citation: 420CFR 412.23(b)(2)
Legal Deadline: None
Abstract: In accordance with the provisions of the Consolidated
Appropriations Act of 2005, the notice announces the Secretary's
determination that the requirements for classification as an inpatient
rehabilitation facility (IRF) specified in section 412.23(b)(2) were
inconsistent with a report that the Government Accountability Office
(GAO) issued concerning classification of a facility as an IRF.
Timetable:
________________________________________________________________________
Action                            Date                      FR Cite
________________________________________________________________________
Notice                          06/24/05                    70 FR 36640
Regulatory Flexibility Analysis Required: No
Small Entities Affected: Businesses, Governmental Jurisdictions
Government Levels Affected: Federal, Local, State
Agency Contact: Robert Kuhl, Division Director, Chronic Care Policy
Group, Division of Institutional Post Acute Care, Department of Health
and Human Services, Centers for Medicare & Medicaid Services, Centers
for Medicare Management, Mailstop C5-26-07, 7500 Security Boulevard,
Baltimore, MD 21244
Phone: 410 786-4597
Email: bob.kuhl@cms.hhs.gov
RIN: 0938-AN92
_______________________________________________________________________
1216. [bull] WITHDRAWAL OF AMBULANCE FEE SCHEDULE ISSUED IN ACCORDANCE
WITH FEDERAL DISTRICT COURT ORDER IN LIFESTAR AMBULANCE, INC. V. U.S.--
MEDICARE COVERED AMBULANCE SERVICES (CMS-1308-)
Priority: Info./Admin./Other
Legal Authority: None
CFR Citation: None
Legal Deadline: None
Abstract: This notice would withdraw the fee schedule that was put in
place to effect compliance with the Court Order in Lifestar Ambulance,
Inc. v. United States. That Order was vacated by the U.S. Court of
Appeals for the Eleventh Circuit in Lifestar Ambulance Service, Inc. v.
United States and, accordingly, is no longer in force.
Timetable:
________________________________________________________________________
Action                            Date                      FR Cite
________________________________________________________________________
Notice                          09/01/05                    70 FR 52105
Regulatory Flexibility Analysis Required: No
Small Entities Affected: No
Government Levels Affected: None
Agency Contact: Ann Tayloe, Health Insurance Specialist, CMS/CMM/HAPG/
DAS, Department of Health and Human Services, Centers for Medicare &
Medicaid Services, 7500 Security Boulevard, C4-07-07, Baltimore, MD
21244
Phone: 410 786-7452
Email: atayloe@cms.hhs.gov
RIN: 0938-AN94
_______________________________________________________________________
1217. [bull] IMMUNIZATION STANDARD FOR LONG TERM CARE FACILITIES (CMS-
3198-F)
Priority: Economically Significant. Major under 5 USC 801.
Legal Authority: 42 USC 1395i-3; SSA 1819 ; 42 USC 1396r; SSA 1919
CFR Citation: 42 CFR 483
Legal Deadline: None
Abstract: This rule would mandate nursing facilities to immunize each
resident for influenza and pneumonia and would reinforces the
residents' rights to receive the immunizations for vaccine-preventable
diseases. The residents will have the right to refuse the
immunizations, if they choose to or if contraindication exist.
Timetable:
________________________________________________________________________
Action                            Date                      FR Cite
________________________________________________________________________
NPRM                            08/15/05                    70 FR 47759
Final Action                    10/07/05                    70 FR 58834
Regulatory Flexibility Analysis Required: No
Small Entities Affected: No
Government Levels Affected: None
Agency Contact: Anita Panicker, Health Insurance Specialist, Department
of Health and Human Services, Centers for Medicare & Medicaid Services,
Clinical Standards Group, Mailstop S3-02-01, 7500 Security Boulevard,
Baltimore, MD 21244
Phone: 410 786-5646
Fax: 410 786-8532
Email: anita.panicker@cms.hhs.gov
RIN: 0938-AN95
_______________________________________________________________________
1218. [bull] DISPROPORTIONATE SHARE HOSPITAL PAYMENTS -- INSTITUTIONS
FOR MENTAL DISEASE (IMDS) (CMS-2209-N)
Priority: Other Significant
Legal Authority: 42 USC 1396r-4; PL 108-173, Sec 1001(a)
CFR Citation: None
Legal Deadline: None
[[Page 64625]]
Abstract: Section 1001(a) of the MMA amended the Act to revise the
methodology for calculating States Disproportionate Share Hospital
(DSH) allotments. CMS published a notice describing this methodology
and States' preliminary FY 2003, and 2004 DSH allotments and
preliminary FY 2003 and 2004 IMD DSH limits in the Federal Register on
3/26/04. This notice announces the final Federal DSH allotments for
Federal fiscal years (FFYs) 2003 and 2004, and the preliminary Federal
share DSH allotments for FFY 2005. It also announces the final FFYs
2003 and 2004, and the preliminary FFY 2005, limitations on aggregate
DSH payments that States may make to institutions for mental disease
and other mental health facilities. This notice also includes a
background describing the methodology for determining the amounts of
States' FFY DSH allotments for FFY 1998 and thereafter.
Timetable:
________________________________________________________________________
Action                            Date                      FR Cite
________________________________________________________________________
Notice                          08/26/05                    70 FR 50358
Regulatory Flexibility Analysis Required: No
Small Entities Affected: No
Government Levels Affected: None
Agency Contact: Richard Strauss, Technical Director, Department of
Health and Human Services, Centers for Medicare & Medicaid Services,
Centers for Medicaid Operations Services, Mailstop S3-13-15, 7500
Security Boulevard, Baltimore, MD 21244
Phone: 410 786-2019
Email: richard.strauss@cms.hhs.gov
Related RIN: Previously reported as 0938-AN88
RIN: 0938-AN96
_______________________________________________________________________
1219. [bull] MEDICARE PRESCRIPTION DRUG DISCOUNT CARD (CMS-4063-F)
Priority: Other Significant
Legal Authority: SSA 1851(d)(1) ; SSA 1860D-1(c); SSA 1860D-
31(h)(7)(B); SSA 1860D-31(h)(8)
CFR Citation: 42 CFR 403; 42 CFR 408
Legal Deadline: None
Abstract: The regulation will finalize the marketing rules for the drug
card program; specifically it will provide current drug card sponsors
who become prescription drug plans (PDPs) the ability to market their
PDP offerings to their current Medicare members. CMS is making the
change because the current regulation provides that an endorsed
sponsor's information and outreach materials may describe only those
products or services within the scope of the Medicare endorsement for
the drug card. The intended effect is to increase Medicare
beneficiaries' awareness and knowledge of PDP offerings for Part D
enrollment effective in 2006. The current draft of the marketing
section in the interim final rule contradicts the intention of the
Medicare Modernization Act to facilitate efficient enrollment into Part
D. The revised final rule will reflect the actual intention of the law.
Timetable:
________________________________________________________________________
Action                            Date                      FR Cite
________________________________________________________________________
Final Action                    09/01/05                    70 FR 52019
Regulatory Flexibility Analysis Required: No
Small Entities Affected: No
Government Levels Affected: None
Agency Contact: Jessica Shapiro, Acting Director, of the Division of
Drug Card Management, Department of Health and Human Services, Centers
for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore,
MD 21244
Phone: 410 786-7407
Fax: 410 786-1048
Related RIN: Related to 0938-AM71
RIN: 0938-AN97
_______________________________________________________________________
1220. [bull] INPATIENT HOSPITAL DEDUCTIBLE AND HOSPITAL AND EXTENDED
CARE SERVICES COINSURANCE AMOUNTS FOR CALENDAR YEAR 2006 (CMS-8026-N)
Priority: Economically Significant. Major under 5 USC 801.
Legal Authority: 42 USC 1395e-2(b)(2); Sec 1813(b)(2) of the Social
Security Act
CFR Citation: None
Legal Deadline: NPRM, Statutory, September 15, 2005.
Abstract: This notice announces the inpatient hospital deductible and
the hospital and extended care services coinsurance amounts for
services furnished in calendar year 2006 under Medicare's Hospital
Insurance program (Medicare Part A). The Medicare statute specifies the
formulae used to determine these amounts.
Timetable:
________________________________________________________________________
Action                            Date                      FR Cite
________________________________________________________________________
Notice                          09/23/05                    70 FR 55885
Regulatory Flexibility Analysis Required: No
Small Entities Affected: No
Government Levels Affected: None
Agency Contact: Clare McFarland, Division Director, Medicare and
Medicaid Cost Estimates Group, Department of Health and Human Services,
Centers for Medicare & Medicaid Services, N3-26-00, Office of the
Actuary, 7500 Security Boulevard, Mailstop N3-26-00, Baltimore, MD
21244
Phone: 410 786-6390
Email: clare.mcfarland@cms.hhs.gov
RIN: 0938-AO00
_______________________________________________________________________
1221. [bull] PART A PREMIUMS FOR CALENDAR YEAR 2006 FOR THE UNINSURED
AGED AND FOR CERTAIN DISABLED INDIVIDUALS WHO HAVE EXHAUSTED OTHER
ENTITLEMENT (CMS-8025-N)
Priority: Economically Significant. Major under 5 USC 801.
Legal Authority: 42 USC 1395i-2(d)(2); 42 USC 1395i thru 2a(d)(2); Sec
1818(d)(2) of the Social Security Act; Sec 1818A(d)(2) of the Social
Security Act
CFR Citation: None
Legal Deadline: None
Abstract: This notice announces the hospital insurance premium for
Calendar Year 2006 under Medicare's Hospital Insurance program
(Medicare Part A) for the uninsured aged and for certain disabled
individuals who have exhausted other entitlement.
Timetable:
________________________________________________________________________
Action                            Date                      FR Cite
________________________________________________________________________
Notice                          09/23/05                    70 FR 55896
Regulatory Flexibility Analysis Required: No
Small Entities Affected: No
Government Levels Affected: None
Agency Contact: Clare McFarland, Division Director, Medicare and
Medicaid Cost Estimates Group, Department of Health and Human
[[Page 64626]]
Services, Centers for Medicare & Medicaid Services, Office of the
Actuary, 7500 Security Boulevard, Mailstop N3-26-00, Baltimore, MD
21244
Phone: 410 786-6390
Email: clare.mcfarland@cms.hhs.gov
RIN: 0938-AO01
_______________________________________________________________________
1222. [bull] MEDICARE PART B MONTHLY ACTUARIAL RATES AND PREMIUM RATE
BEGINNING JANUARY 1, 2006 (CMS-8027-N)
Priority: Economically Significant. Major under 5 USC 801.
Legal Authority: 42 USC 1395r; Sec 1839 of the Social Security Act; Sec
629 of MMA; Sec 811 of MMA
CFR Citation: None
Legal Deadline: None
Abstract: This notice announces the monthly actuarial rates for aged
(age 65 and over) and disabled (under age 65) enrollees in Part B of
Medicare for 2006. It also announces the monthly Part B premium to be
paid by all enrollees, and the Part B deductible, during 2006. Section
629 of the Medicare Modernization Act requires indexing the Part B
deductible to the increase in the Part B aged actuarial rate beginning
1/1/06.
Timetable:
________________________________________________________________________
Action                            Date                      FR Cite
________________________________________________________________________
Notice                          09/23/05                    70 FR 55897
Regulatory Flexibility Analysis Required: No
Small Entities Affected: No
Government Levels Affected: None
Agency Contact: Suzanne Codespote, Division Director, Medicare and
Medicaid Cost Estimates Group, Department of Health and Human Services,
Centers for Medicare & Medicaid Services, Office of the Actuary, 7500
Security Boulevard, Mailstop N3-26-00, Baltimore, MD 21244
Phone: 410 786-7737
Email: suzanne.codespote@ cms.hhs.gov
RIN: 0938-AO02
_______________________________________________________________________
Department of Health and Human Services (HHS)       Proposed Rule Stage
Administration for Children and Families (ACF)
_______________________________________________________________________
1223. SAFEGUARDING CHILD SUPPORT AND EXPANDED FEDERAL PARENT LOCATOR
SERVICES (FPLS) INFORMATION
Priority: Other Significant
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                            11/00/05
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
_______________________________________________________________________
1224. DEVELOPMENTAL DISABILITIES AND BILL OF RIGHTS ACT
Priority: Substantive, Nonsignificant
Legal Authority: PL 106-402; 42 USC 15001 et seq
CFR Citation: 45 CFR 1385 to 1388
Legal Deadline: Final, Statutory, October 30, 2001.
Abstract: A notice of proposed rulemaking to amend current regulations
and to implement changes made by the Developmental Disabilities
Assistance and Bill of Rights Act of 2000.
Timetable:
________________________________________________________________________
Action                            Date                      FR Cite
________________________________________________________________________
NPRM                            12/00/05
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
_______________________________________________________________________
1225. 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 require States (including the
District of Columbia) and territories to use the ``benefiting'' cost
allocation methodology in allocating the common administrative costs of
determining eligibility in the Temporary Assistance for Needy Families
(TANF) program,
[[Page 64627]]
the Medicaid program, and the Food Stamp programs.
Timetable:
________________________________________________________________________
Action                            Date                      FR Cite
________________________________________________________________________
NPRM                            12/00/05
Regulatory Flexibility Analysis Required: No
Small Entities Affected: No
Government Levels Affected: Local, State
Agency Contact: Grant Collins, Deputy Director, Department of Health
and Human Services, Administration for Children and Families, 5th Floor
East, 370 L'Enfant Promenade SW., Washington, DC 20447
Phone: 202 401-6953
Email: gcollins@acf.hhs.gov
RIN: 0970-AC15
_______________________________________________________________________
1226. CARE AND PLACEMENT OF UNACCOMPANIED ALIEN CHILDREN
Priority: Other Significant
Legal Authority: 6 USC 279
CFR Citation: 45 CFR 410
Legal Deadline: None
Abstract: This rule concerns the placement of unaccompanied alien
children in appropriate facilities and homes, the services provided for
the children while they are in the care of the Office of Refugee
Resettlement (ORR) and the criteria for release of these children from
Federal custody to sponsors. The rule also implements ORR's role in
Flores class-action settlement agreement.
Timetable:
________________________________________________________________________
Action                            Date                      FR Cite
________________________________________________________________________
NPRM                            11/01/05
Regulatory Flexibility Analysis Required: No
Small Entities Affected: No
Government Levels Affected: Federal
Agency Contact: Maureen Dunn, Department of Health and Human Services,
Administration for Children and Families, 370 L'Enfant Promenade SW.,
Washington, DC 20447
Phone: 202 401-5523
Email: mdunn@acf.hhs.gov
RIN: 0970-AC20
_______________________________________________________________________
1227. CHAFEE NATIONAL YOUTH IN TRANSITION DATABASE
Priority: Other Significant
Legal Authority: 42 USC 677
CFR Citation: 45 CFR 1356
Legal Deadline: None
Abstract: This rule would require States to collect and report data on
youth who are receiving independent living services and the outcomes of
certain youth who are in foster care or who age-out of foster care.
Timetable:
________________________________________________________________________
Action                            Date                      FR Cite
________________________________________________________________________
NPRM                            12/00/05
Regulatory Flexibility Analysis Required: No
Small Entities Affected: No
Government Levels Affected: State
Agency Contact: Kathleen McHugh, Divison Director, Children's Bureau
Policy, Department of Health and Human Services, Administration for
Children and Families, Room 2411, 330 C Street SW., Washington, DC
20447
Phone: 202 401-5789
Fax: 202 205-8221
Email: kmchugh@acf.hhs.gov
RIN: 0970-AC21
_______________________________________________________________________
1228. MEDICAL SUPPORT
Priority: Other Significant. Major status under 5 USC 801 is
undetermined.
Legal Authority: 42 USC 1302
CFR Citation: 45 CFR 302; 45 CFR 303; 45 CFR 304; 45 CFR 305
Legal Deadline: None
Abstract: These rules would require that all support orders in the IV-D
program address medical support, redefine reasonable-cost health
insurance, require health insurance to be accessible, and make
conforming changes to audit and self-assessment requirements.
Timetable:
________________________________________________________________________
Action                            Date                      FR Cite
________________________________________________________________________
NPRM                            12/00/05
Regulatory Flexibility Analysis Required: No
Small Entities Affected: Governmental Jurisdictions
Government Levels Affected: Local, State
Agency Contact: Elizabeth C. Matheson, Director, Policy and Planning
Division, Department of Health and Human Services, Administration for
Children and Families, Office of Child Support Enforcement, 370
L'Enfant Promenade SW., Washington, DC 20447
Phone: 202 401-9386
Email: bmatheson@acf.dhhs.gov
RIN: 0970-AC22
_______________________________________________________________________
1229. [bull] ADOPTION AND FOSTER CARE ANALYSIS AND REPORTING SYSTEM
Priority: Substantive, Nonsignificant
Legal Authority: 42 USC 679
CFR Citation: 45 CFR 1355
Legal Deadline: None
Abstract: This NPRM amends the Adoption and Foster Care Analysis and
Reporting System (AFCARS) regulations at 45 CFR 1355.40 and the
appendices to part 1355 to modify the requirements for States to
collect and report data to ACF on children in foster care and in
subsidized adoption or guardianship arrangements with the State. The
rule also implements the AFCARS penalty requirements of the Adoption
Promotion Act of 2003 (P.L. 108-145).
Timetable:
________________________________________________________________________
Action                            Date                      FR Cite
________________________________________________________________________
NPRM                            02/00/06
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-AC23
[[Page 64628]]
_______________________________________________________________________
Department of Health and Human Services (HHS)          Final Rule Stage
Administration for Children and Families (ACF)
_______________________________________________________________________
1230. ADMINISTRATIVE COSTS FOR CHILDREN IN TITLE IV-E FOSTER CARE
Priority: Other Significant
Legal Authority: 42 USC 672; 42 USC 674; 42 USC 1302
CFR Citation: 45 CFR 1356.60(c)
Legal Deadline: None
Abstract: This notice of proposed rulemaking implements the title IV-E
foster care eligibility and administrative cost provisions in sections
472 and 474 of the Social Security Act. We propose to prohibit the
reimbursement of administrative costs claimed on behalf of children in
unlicensed foster family homes, with the exception of children in
relative foster family homes while the State is in the process of
licensing the home. We also propose to prohibit the reimbursement of
administrative costs claimed on behalf of children in unallowable
facilities, with the exception of the month prior to a child's
transition into an allowable facility.
Timetable:
________________________________________________________________________
Action                            Date                      FR Cite
________________________________________________________________________
NPRM                            01/31/05                     70 FR 4803
Final Action                    11/00/05
Regulatory Flexibility Analysis Required: No
Small Entities Affected: No
Government Levels Affected: State
Agency Contact: Kathleen McHugh, Divison Director, Children's Bureau
Policy, Department of Health and Human Services, Administration for
Children and Families, Room 2411, 330 C Street SW., Washington, DC
20447
Phone: 202 401-5789
Fax: 202 205-8221
Email: kmchugh@acf.hhs.gov
RIN: 0970-AC14
_______________________________________________________________________
1231. 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                    01/00/06
Regulatory Flexibility Analysis Required: No
Government Levels Affected: None
Agency Contact: Windy Hill, Associate Commissioner, Head Start Bureau,
Department of Health and Human Services, 330 C Street SW., Washington,
DC 20447
Phone: 202 205-8573
Email: whill@acf.hhs.gov
RIN: 0970-AC16
_______________________________________________________________________
1232. 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                    12/00/05
Regulatory Flexibility Analysis Required: No
Small Entities Affected: No
Government Levels Affected: Local, State
Agency Contact: Karen Tvedt, Policy Director, Child Care Bureau,
Department of Health and Human Services, Administration for Children
and Families, 330 C Street SW., Room 2046, Washington, DC 20447
Phone: 202 401-5130
Email: ktvedt@acf.hhs.gov
RIN: 0970-AC18
_______________________________________________________________________
1233. REASONABLE QUANTITATIVE STANDARD FOR REVIEW AND ADJUSTMENT OF
CHILD SUPPORT ORDERS
Priority: Other Significant
Legal Authority: 42 USC 1302
CFR Citation: 45 CFR 303
Legal Deadline: None
Abstract: This interim final rule permits States to use reasonable
quantitative standards in adjusting an existing child support award
amount after conducting review of the order, regardless of the method
review.
Timetable:
________________________________________________________________________
Action                            Date                      FR Cite
________________________________________________________________________
Interim Final Rule              12/28/04                    69 FR 77659
Final Action                    12/00/05
Regulatory Flexibility Analysis Required: No
Small Entities Affected: No
Government Levels Affected: Local, State
Agency Contact: Elizabeth C. Matheson, Director, Policy and Planning
Division, Department of Health and Human Services, Administration for
Children and Families, Office of Child Support Enforcement, 370
L'Enfant Promenade SW., Washington, DC 20447
Phone: 202 401-9386
Email: bmatheson@acf.dhhs.gov
RIN: 0970-AC19
[FR Doc. 05-21044 Filed 10-28-05; 8:45 am]
BILLING CODE 4150-24-S
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