[December 11, 2006 (Volume 71, Number 237)] [Unified Agenda] From the Federal Register Online via GPO Access [frwais.access.gpo.gov] [DOCID: f:ua061008.wais] [Page 73196-73275] Department of Health and Human Services ----------------------------------------------------------------------- Part VIII ----------------------------------------------------------------------- Semiannual Regulatory Agenda [[Page 73196]] 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 the following inventory of 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 consideration. Members of the public wishing to communicate to the Department their views on the potential rulemakings outlined below are invited to do so. FOR FURTHER INFORMATION CONTACT: Ann C. Agnew, Executive Secretary, Department of Health and Human Services, Washington, DC 20201. SUPPLEMENTARY INFORMATION: The capsulized information provided below presents for public scrutiny a forecast of the rulemaking activities that the Department expects to undertake over the foreseeable future. We focus primarily on those areas of work expected to result in publication of Notices of Proposed Rulemaking or Final Rules within the next 12 months. We welcome the views of all concerned with regard to 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 15, 2006. 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............................................................. ---------------------------------------------------------------------------------------------------------------- Office of the Secretary--Final Rule Stage ---------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Number Number ---------------------------------------------------------------------------------------------------------------- 986 Shared Risk Exception to the Safe Harbor Provisions................................... 0991-AA91 987 Safe Harbor for Waiver of Beneficiary Coinsurance and Deductible Amounts for a 0991-AB16 Medicare SELECT Policy................................................................ 988 Debt Collection....................................................................... 0991-AB18 989 Salary Offset......................................................................... 0991-AB19 990 Clarification of Terms and Application of Program Exclusion Authority for Submitting 0991-AB23 Claims Containing Excessive Charges................................................... 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 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 ---------------------------------------------------------------------------------------------------------------- 993 Medicare and State Health Care Programs: Fraud and Abuse; Safe Harbor for Certain 0991-AB39 Electronic Prescribing Arrangements Under the Anti-Kickback Statute................... ---------------------------------------------------------------------------------------------------------------- [[Page 73197]] Substance Abuse and Mental Health Services Administration--Proposed Rule Stage ---------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Number Number ---------------------------------------------------------------------------------------------------------------- 994 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 ---------------------------------------------------------------------------------------------------------------- 995 Mandatory Guidelines for the Federal Workplace Drug Testing Program................... 0930-AA12 ---------------------------------------------------------------------------------------------------------------- Centers for Disease Control and Prevention--Prerule Stage ---------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Number Number ---------------------------------------------------------------------------------------------------------------- 996 Foreign Quarantine Regulations, Proposed Revision of HHS/CDC Animal Importation 0920-AA14 Regulations........................................................................... 997 Amendments to Powered Air-Purifying Respirator Requirements for Approval of 0920-AA16 Respiratory Protection Devices........................................................ 998 Amendments to Performance Requirements for Chemical Biological, Radiological, and 0920-AA17 Nuclear (CBRN) Approval of Respiratory Protection Devices............................. ---------------------------------------------------------------------------------------------------------------- Centers for Disease Control and Prevention--Proposed Rule Stage ---------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Number Number ---------------------------------------------------------------------------------------------------------------- 999 Amendments to Quality Assurance and Administrative Provision for Approval of 0920-AA04 Respiratory Protective Devices........................................................ 1000 Amendments to Self-Contained Breathing Apparatus Requirements for Approval of 0920-AA10 Respiratory Protective Devices........................................................ 1001 Amendments to Requirements for Coal Mine Dust Personal Sampler Units.................. 0920-AA18 ---------------------------------------------------------------------------------------------------------------- Centers for Disease Control and Prevention--Final Rule Stage ---------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Number Number ---------------------------------------------------------------------------------------------------------------- 1002 Control of Communicable Diseases, Interstate and Foreign Quarantine (Reg Plan Seq No. 0920-AA12 35)................................................................................... 1003 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...................................................................... 1004 Interstate Shipment of Etiologic Agents............................................... 0920-AA19 ---------------------------------------------------------------------------------------------------------------- References in boldface appear in the Regulatory Plan in part II of this issue of the Federal Register. Food and Drug Administration--Prerule Stage ---------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Number Number ---------------------------------------------------------------------------------------------------------------- 1005 Over-the-Counter (OTC) Drug Review--Sunscreen Products................................ 0910-AF43 1006 Medical Devices; Current Good Manufacturing Practice (CGMP) Final Rule; Quality 0910-AF71 Systems Regulations (Section 610 Review).............................................. 1007 Package Size Limitation for Sodium Phosphates Oral Solution and Warning and Direction 0910-AF73 Statements for Oral and Rectal Sodium Phosphates for Over-the-Counter Laxative Use (Section 610 Review).................................................................. 1008 Over-the-Counter Drug Products Containing Analgesic/Antipyretic Active Ingredients for 0910-AF74 Internal Use: Required Alcohol Warning (Section 610 Review)........................... 1009 Status of Certain Additional Over-the-Counter Drug Category II and III Active 0910-AF75 Ingredients (Section 610 Review)...................................................... [[Page 73198]] 1010 Medical Devices: Classification/Reclassification; Restricted Devices; Analyte Specific 0910-AF76 Reagents (Section 610 Review)......................................................... 1011 Amended Economic Impact Analysis of Final Rule on User Labeling on Natural Rubber- 0910-AF77 Containing Medical Device (Section 610 Review)........................................ 1012 Financial Disclosure by Clinical Investigators (Section 610 Review)................... 0910-AF79 1013 Beverages: Bottled Water (Section 610 Review)......................................... 0910-AF80 1014 Food Labeling; Nutrient Content Claims: Definition for ``High Potency'' and Definition 0910-AF83 of ``Antioxidant'' for Use in Nutrient Content Claims for Dietary Supplements and Conventional Foods (Section 610 Review)............................................... ---------------------------------------------------------------------------------------------------------------- Food and Drug Administration--Proposed Rule Stage ---------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Number Number ---------------------------------------------------------------------------------------------------------------- 1015 Medical Devices; Anesthesiology Devices; Proposed Reclassification of Pressure 0910-AC30 Regulators for Use With Medical Oxygen and Separate Classification of Oxygen Conserving Devices.................................................................... 1016 Electronic Submission of Data From Studies Evaluating Human Drugs and Biologics (Reg 0910-AC52 Plan Seq No. 36)...................................................................... 1017 Reporting Information Regarding Falsification of Data................................. 0910-AC59 1018 Content and Format of Labeling for Human Prescription Drugs and Biologics; 0910-AF11 Requirements for Pregnancy and Lactation Labeling (Reg Plan Seq No. 37)............... 1019 Charging for Investigational Drugs.................................................... 0910-AF13 1020 Expanded Access to Investigational Drugs for Treatment Use (Reg Plan Seq No. 38)...... 0910-AF14 1021 Blood Initiative--Requirements for Human Blood and Blood Components Intended for 0910-AF25 Transfusion or for Further Manufacturing Use.......................................... 1022 Over-the-Counter (OTC) Drug Review--Internal Analgesic Products....................... 0910-AF36 1023 Over-the-Counter (OTC) Drug Review--Labeling of Drug Products for OTC Human Use....... 0910-AF37 1024 Over-the-Counter (OTC) Drug Review--Ophthalmic Products............................... 0910-AF39 1025 Over-the-Counter (OTC) Drug Review--Oral Health Care Products......................... 0910-AF40 1026 Over-the-Counter (OTC) Drug Review--Skin Bleaching Products........................... 0910-AF53 1027 Use of Materials Derived From Cattle in Medical Products Intended for Use in Humans 0910-AF54 and Drugs Intended for Use in Ruminants............................................... 1028 Over-the-Counter (OTC) Drug Review--Stimulant Drug Products........................... 0910-AF56 1029 Label Requirement for Food That Has Been Refused Admission Into the United States (Reg 0910-AF61 Plan Seq No. 39)...................................................................... 1030 Over-the-Counter Antidiarrheal Drug Products.......................................... 0910-AF63 1031 Index of Legally Marketed Unapproved New Animal Drugs for Minor Species............... 0910-AF67 1032 Over-the-Counter (OTC) Drug Review--Poison Treatment Drug Products.................... 0910-AF68 1033 Over-the-Counter (OTC) Drug Review--Topical Antimicrobial Drug Products............... 0910-AF69 1034 Over-the-Counter (OTC) Drug Review--Urinary Analgesic Drug Products................... 0910-AF70 1035 Import Tolerances for Animal Drugs.................................................... 0910-AF78 1036 Current Good Manufacturing Practice for Combination Products.......................... 0910-AF81 1037 Postmarket Safety Reporting for Combination Products.................................. 0910-AF82 1038 Revisions to the Requirements Applicable to Blood, Blood Components, and Source Plasma 0910-AF84 1039 Revision of the Requirements for Live Vaccine Processing.............................. 0910-AF85 1040 Medical Device Reporting; Electronic Submission Requirements (Reg Plan Seq No. 40).... 0910-AF86 1041 Laser Products; Amendment to Performance Standard..................................... 0910-AF87 1042 Electronic Registration and Listing for Devices (Reg Plan Seq No. 41)................. 0910-AF88 1043 Regulations on Fixed-Combination Drug Products........................................ 0910-AF89 1044 Use of Ozone-Depleting Substances; Removal of Essential Use Designations [epinephrine] 0910-AF92 1045 Use of Ozone-Depleting Substances; Removal of Essential Use Designations [flunisolide, 0910-AF93 triamcinolone, metaproterenol, pirbuterol, albuterol and ipratropium in combination, cromolyn, and nedocromil]............................................................. ---------------------------------------------------------------------------------------------------------------- References in boldface appear in the Regulatory Plan in part II of this issue of the Federal Register. [[Page 73199]] Food and Drug Administration--Final Rule Stage ---------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Number Number ---------------------------------------------------------------------------------------------------------------- 1046 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.......................................................................... 1047 Safety Reporting Requirements for Human Drug and Biological Products.................. 0910-AA97 1048 Applications for FDA Approval To Market a New Drug; Complete Response Letter; 0910-AB34 Amendments to Unapproved Applications................................................. 1049 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).................................................................. 1050 Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Dietary 0910-AB88 Ingredients and Dietary Supplements (Reg Plan Seq No. 42)............................. 1051 Additional Safeguards for Children in Clinical Investigations......................... 0910-AC07 1052 Prevention of Salmonella Enteritidis in Shell Eggs.................................... 0910-AC14 1053 Institutional Review Boards: Registration Requirements................................ 0910-AC17 1054 Exception From General Requirements for Informed Consent; Request for Comments and 0910-AC25 Information........................................................................... 1055 Medical Devices; Patient Examination and Surgeons' Gloves; Test Procedures and 0910-AC32 Acceptance Criteria................................................................... 1056 Toll-Free Number for Reporting Adverse Events on Labeling for Human Drugs............. 0910-AC35 1057 Prior Notice of Imported Food Under the Public Health Security and Bioterrorism 0910-AC41 Preparedness and Response Act of 2002 (Reg Plan Seq No. 43)........................... 1058 Medical Gas Containers and Closures; Current Good Manufacturing Practice Requirements. 0910-AC53 1059 Positron Emission Tomography Drugs; Current Good Manufacturing Practices.............. 0910-AC55 1060 Human Subject Protection; Foreign Clinical Studies Not Conducted Under an 0910-AF15 Investigational New Drug Application.................................................. 1061 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............................................................. 1062 Obstetrical and Gynecological Devices; Designation of Special Control for Condoms and 0910-AF21 Condoms With Spermicidal Lubricant.................................................... 1063 Blood Initiative--Revisions to Labeling Requirements for Blood and Blood Components, 0910-AF26 Including Source Plasma; and Technical Amendment...................................... 1064 Infant Formula: Current Good Manufacturing Practices; Quality Control Procedures; 0910-AF27 Notification Requirements; Records and Reports........................................ 1065 Infant Formula Quality Factors........................................................ 0910-AF28 1066 Over-the-Counter (OTC) Drug Review--Cough/Cold (Antihistamine) Products............... 0910-AF31 1067 Over-the-Counter (OTC) Drug Review--Cough/Cold (Bronchodilator) Products.............. 0910-AF32 1068 Over-the-Counter (OTC) Drug Review--Cough/Cold (Combination) Products................. 0910-AF33 1069 Over-the-Counter (OTC) Drug Review--Cough/Cold (Nasal Decongestant) Products.......... 0910-AF34 1070 Over-the-Counter (OTC) Drug Review--External Analgesic Products....................... 0910-AF35 1071 Over-the-Counter (OTC) Drug Review--Laxative Drug Products............................ 0910-AF38 1072 Over-the-Counter (OTC) Drug Review--Skin Protectant Products.......................... 0910-AF42 1073 Over-the-Counter (OTC) Drug Review--Vaginal Contraceptive Products.................... 0910-AF44 1074 Over-the-Counter (OTC) Drug Review--Weight Control Products........................... 0910-AF45 1075 Over-the-Counter (OTC) Drug Review--Dandruff, Seborrheic Dermatitis, and Psoriasis 0910-AF49 Products.............................................................................. 1076 Over-the-Counter (OTC) Drug Review--Overindulgence in Food and Drink Products......... 0910-AF51 1077 Over-the-Counter (OTC) Drug Review--Antacid Products.................................. 0910-AF52 1078 Supplements and Other Changes to Approved New Animal Drug Applications................ 0910-AF59 1079 Designation of New Animal Drugs for Minor Uses or Minor Species....................... 0910-AF60 1080 Blood Vessels Recovered With Organs and Intended for Use in Organ Transplantation..... 0910-AF65 1081 Exceptions or Alternatives to Labeling Requirements for Products Held by the Strategic 0910-AF90 National Stockpile.................................................................... ---------------------------------------------------------------------------------------------------------------- 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 ---------------------------------------------------------------------------------------------------------------- 1082 Chronic Wasting Disease: Control of Food Products and Cosmetics Derived From Exposed 0910-AC21 Animal Populations.................................................................... 1083 Requirements for Submission of In Vivo Bioequivalence Data............................ 0910-AC23 1084 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..... 1085 Food Standards: General Principles and Food Standards Modernization................... 0910-AC54 [[Page 73200]] 1086 Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding 0910-AF08 of Drugs; Revision of Certain Labeling Controls....................................... 1087 Health Claims......................................................................... 0910-AF09 1088 Cochineal Extract and Carmine Label Declaration....................................... 0910-AF12 1089 Food Labeling; Prominence of Calories................................................. 0910-AF22 1090 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.................................................... 1091 Substances Prohibited From Use in Animal Food or Feed................................. 0910-AF46 1092 Use of Materials Derived From Cattle in Human Food and Cosmetics...................... 0910-AF47 ---------------------------------------------------------------------------------------------------------------- Food and Drug Administration--Completed Actions ---------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Number Number ---------------------------------------------------------------------------------------------------------------- 1093 Revocation of the Status of Specific Products; Group A Streptococcus.................. 0910-AF20 1094 Recordkeeping Requirements for Human Food and Cosmetics Manufactured From, Processed 0910-AF48 With, or Otherwise Containing Material From Cattle.................................... ---------------------------------------------------------------------------------------------------------------- Health Resources and Services Administration--Proposed Rule Stage ---------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Number Number ---------------------------------------------------------------------------------------------------------------- 1095 Designation of Medically Underserved Populations and Health Professional Shortage 0906-AA44 Areas................................................................................. ---------------------------------------------------------------------------------------------------------------- Health Resources and Services Administration--Final Rule Stage ---------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Number Number ---------------------------------------------------------------------------------------------------------------- 1096 National Practitioner Data Bank for Adverse Information on Physicians and Other Health 0906-AA57 Care Practitioners: Reporting Adverse and Negative Actions............................ 1097 Intestines Added to the Definition of Organs Covered by the Rules Governing the 0906-AA62 Operation of the Organ Procurement and Transplantation Network (OPTN)................. 1098 Requirements Establishing a Limitation on Administrative Expenses; Ryan White CARE Act 0906-AA65 Title IV Grants for Coordinated Services and Access to Research....................... 1099 National Vaccine Injury Compensation Program: Calculation of Average Cost of a Health 0906-AA68 Insurance Policy...................................................................... 1100 Healthy Tomorrow's Partnership for Children (HTPC) Program............................ 0906-AA70 ---------------------------------------------------------------------------------------------------------------- Health Resources and Services Administration--Long-Term Actions ---------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Number Number ---------------------------------------------------------------------------------------------------------------- 1101 National Practitioner Data Bank for Adverse Information on Physicians and Other Health 0906-AA41 Care Practitioners: Medical Malpractice Payments Reporting Requirements............... 1102 Operation of the Organ Procurement and Transplantation Network (OPTN)................. 0906-AA63 ---------------------------------------------------------------------------------------------------------------- [[Page 73201]] Health Resources and Services Administration--Completed Actions ---------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Number Number ---------------------------------------------------------------------------------------------------------------- 1103 Smallpox Vaccine Injury Compensation Program: Smallpox (Vaccinia) Vaccine Injury Table 0906-AA60 1104 Smallpox Vaccine Injury Compensation Program: Administrative Implementation........... 0906-AA61 ---------------------------------------------------------------------------------------------------------------- Indian Health Service--Final Rule Stage ---------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Number Number ---------------------------------------------------------------------------------------------------------------- 1105 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 ---------------------------------------------------------------------------------------------------------------- 1106 Grants for Research Projects.......................................................... 0925-AA42 1107 National Institutes of Health Loan Repayment Programs................................. 0925-AA43 1108 National Library of Medicine Training Grants.......................................... 0925-AA44 1109 Minority Biomedical Research Support Program.......................................... 0925-AA45 1110 National Institute of Environmental Health Sciences Hazardous Substances Basic 0925-AA46 Research and Training Grants.......................................................... 1111 Endowment Program..................................................................... 0925-AA47 1112 Undergraduate Scholarship Program Regarding Professions Needed by the National 0925-AA48 Institutes of Health.................................................................. 1113 NIH Training Grants................................................................... 0925-AA49 1114 NIH Center Grants..................................................................... 0925-AA50 1115 NIH Construction Grant................................................................ 0925-AA51 ---------------------------------------------------------------------------------------------------------------- National Institutes of Health--Final Rule Stage ---------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Number Number ---------------------------------------------------------------------------------------------------------------- 1116 Standards for a National Chimpanzee Sanctuary System.................................. 0925-AA31 ---------------------------------------------------------------------------------------------------------------- National Institutes of Health--Completed Actions ---------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Number Number ---------------------------------------------------------------------------------------------------------------- 1117 National Institutes of Health Training Grants......................................... 0925-AA28 ---------------------------------------------------------------------------------------------------------------- Office of Public Health and Science--Prerule Stage ---------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Number Number ---------------------------------------------------------------------------------------------------------------- 1118 Human Subjects Protection Regulations: Additional Protections for Adult Individuals 0940-AA11 With Impaired Decisionmaking Capacity................................................. ---------------------------------------------------------------------------------------------------------------- [[Page 73202]] Office of Public Health and Science--Final Rule Stage ---------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Number Number ---------------------------------------------------------------------------------------------------------------- 1119 Human Subjects Protection Regulations: Institutional Review Boards Registration 0940-AA06 Requirements.......................................................................... ---------------------------------------------------------------------------------------------------------------- Office of Public Health and Science--Long-Term Actions ---------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Number Number ---------------------------------------------------------------------------------------------------------------- 1120 Public Health Service Standards for the Protection of Research Misconduct 0940-AA01 Whistleblowers........................................................................ 1121 Human Subjects Protection Regulations: Training and Ed. Requirements for Institutional 0940-AA08 Officials, Institutional Review Board Members and Staff, Human Protections Administrators, and Investigators..................................................... ---------------------------------------------------------------------------------------------------------------- Centers for Medicare & Medicaid Services--Proposed Rule Stage ---------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Number Number ---------------------------------------------------------------------------------------------------------------- 1122 Home Health Agency (HHA) Conditions of Participation (CoPs) (CMS-3819-P) (Section 610 0938-AG81 Review)............................................................................... 1123 Appeals of CMS or Contractor Determinations When a Provider or Supplier Fails To Meet 0938-AI49 the Requirements for Medicare Billing (CMS-6003-P2)................................... 1124 Rural Health Clinics: Amendments to Participation Requirements and Payment Provisions 0938-AJ17 and Establishment of a Quality Assessment and Improvement Program (CMS-1910-P2)....... 1125 Use of Restraints and Seclusion in Medicare and Medicaid Participating Facilities That 0938-AL26 Provide Inpatient or Residential Care (CMS-2130-P).................................... 1126 Revisions to Conditions for Coverage for Ambulatory Surgical Centers (CMS-3887-P)..... 0938-AL80 1127 Modifications to Electronic Transactions and Code Sets (CMS-0009-P)................... 0938-AM50 1128 Requirements for Long-Term Care Facilities: Hospice Services (CMS-3140-P)............. 0938-AM87 1129 Revisions to HIPAA Code Sets (CMS-0013-P)............................................. 0938-AN25 1130 National Plan and Provider Enumeration System (NPPES) Data Dissemination (CMS-6060-NC) 0938-AN71 1131 Changes to the Disclosure of Information Requirements for Quality Improvement 0938-AN73 Organizations (CMS-3156-P)............................................................ 1132 Fire Safety Requirements for Long-Term Care Facilities: Sprinkler Systems (CMS-3191-P) 0938-AN79 1133 Payments for Service Provided Without Charge (CMS-2489-P)............................. 0938-AO07 1134 Medical Improvement Eligibility Group and Definition of Work (CMS-2143-P)............. 0938-AO10 1135 Outpatient Hospital Services and Rural Health Clinic Services Amendment (CMS-2213-P).. 0938-AO17 1136 Medicaid Prescription Drugs -- Average Manufacturer Price (CMS-2238-P)................ 0938-AO20 1137 Use of Repayment Plans (CMS-6032-P)................................................... 0938-AO27 1138 Redistribution of Unexpended State Children's Health Insurance Program (SCHIP) Funds 0938-AO28 From the Appropriation for Fiscal Year 2004 (CMS-2241-NC)............................. 1139 Prospective Payment System for Long-Term Care Hospitals RY 2008: Annual Payment Rate 0938-AO30 Updates (CMS-1529-P) (Reg Plan Seq No. 44)............................................ 1140 Home Health Prospective Payment System Rate Update for Calendar Year 2008 (CMS-1541-P) 0938-AO32 1141 Gynecological Cytology Proficiency Testing Requirements for Laboratories, Individuals, 0938-AO34 and Proficiency Testing Program Approvals (CMS-2252-P)................................ 1142 State Option To Establish Non-Emergency Medical Transportation Program (CMS-2234-P)... 0938-AO45 1143 Cost Sharing Options (CMS-2244-P)..................................................... 0938-AO47 1144 State Flexibility for Medicaid Benefit Packages (CMS-2232-P).......................... 0938-AO48 1145 Home and Community-Based Services (HCBS) State Plan Option (CMS-2249-P)............... 0938-AO53 1146 Medicare Part D Data (CMS-4119-P)..................................................... 0938-AO58 1147 Prospective Payment System for Inpatient Rehabilitation Facilities for FY 2008 (CMS- 0938-AO63 1551-P)............................................................................... 1148 Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities-- 0938-AO64 Update for FY 2008 (CMS-1545-P)....................................................... 1149 Revisions to Payment Policies Under the Physician Fee Schedule for Calendar Year 2008 0938-AO65 (CMS-1385-P).......................................................................... 1150 Standards for E-Prescribing Under Medicare Part D (CMS-0016-P) (Reg Plan Seq No. 45).. 0938-AO66 1151 Exemption of Privacy Act Disclosure of Certain Investigative Materials (CMS-0029-P)... 0938-AO69 1152 Changes to the Hospital Inpatient Prospective Payment Systems and FY 2008 Rates (CMS- 0938-AO70 1533-P) (Reg Plan Seq No. 46)......................................................... 1153 Changes to the Hospital Outpatient Prospective Payment System and Calendar Year 2008 0938-AO71 Payment Rates (CMS-1392-P)............................................................ [[Page 73203]] 1154 Hospice Wage Index for FY 2008 (CMS-1539-P)........................................... 0938-AO72 1155 Special Enrollment Period and Medicare Premium Changes (CMS-4129-P)................... 0938-AO77 1156 Revisions to the Medicare Advantage and Part D Prescription Drug Contract 0938-AO78 Confidentiality and Disclosure, Determinations, Appeals, and Intermediate Sanctions Processes (CMS-4124-P) (Reg Plan Seq No. 47).......................................... ---------------------------------------------------------------------------------------------------------------- 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 ---------------------------------------------------------------------------------------------------------------- 1157 Hospital Conditions of Participation: Laboratory Services (CMS-3014-IFC) (Section 610 0938-AJ29 Review)............................................................................... 1158 Use of Restraints and Seclusion in Residential Treatment Facilities Providing 0938-AJ96 Inpatient Psychiatric Services to Individuals Under Age 21 (CMS-2065-F)............... 1159 Physicians' Referrals to Health Care Entities With Which They Have Financial 0938-AK67 Relationships (CMS-1810-F)............................................................ 1160 Provider Reimbursement Determinations and Appeals (CMS-1727-F)........................ 0938-AL54 1161 Revised Civil Money Penalties, Assessments, Exclusions, and Related Appeals Procedures 0938-AM98 (CMS-6146-F).......................................................................... 1162 Enhanced DSH Treatment for Certain Hospitals (CMS-2198-F)............................. 0938-AN09 1163 Competitive Acquisition for Certain Durable Medical Equipment (DME), Prosthetics, 0938-AN14 Orthotics, and Supplies (CMS-1270-F) (Reg Plan Seq No. 48)............................ 1164 Nondiscrimination in Health Coverage in the Group Market (CMS-4081-F)................. 0938-AN29 1165 Hospital Conditions of Participation: Patients' Rights (CMS-3018-F)................... 0938-AN30 1166 Program for All-Inclusive Care for the Elderly (PACE): Program Revisions (CMS-1201-F). 0938-AN83 1167 Special Medicare GME Affillations for a Teaching Hospital Affected by a Disaster (CMS- 0938-AO35 1531-F2).............................................................................. 1168 Inpatient Psychiatric Facility Prospective Payment System--Update for Rate Year 0938-AO40 Beginning July 1, 2007 (RY 2008) (CMS-1479-N)......................................... 1169 Group Health Plans and Health Insurance Issues Under the Newborns and Mothers Health 0938-AO43 Protection Act (CMS-4116-F)........................................................... 1170 High Risk Pools (CMS-2260-IFC)........................................................ 0938-AO46 1171 Targeted Case Management (CMS-2237-IFC)............................................... 0938-AO50 1172 Citizenship Documentation Requirements (CMS-2257-F)................................... 0938-AO51 1173 Self-Directed Personal Assistance Services State Plan Option (CMS-2229-IFC)........... 0938-AO52 1174 Inpatient Hospital Deductible and Hospital and Extended Care Services Coinsurance 0938-AO61 Amounts for CY 2008 (CMS-8032-N)...................................................... 1175 Part A Premiums for CY 2008 for the Uninsured Aged and for Certain Disabled 0938-AO62 Individuals Who Have Exhausted Other Entitlement (CMS-8031-N)......................... 1176 Part B Monthly Actuarial Rates and Premium Rates Beginning January 1, 2008 (CMS-8033- 0938-AO68 N).................................................................................... 1177 Revised Payment System for Services Furnished in Ambulatory Surgical Centers (ASCs) 0938-AO73 Effective January 1, 2008 (CMS-1517-F)................................................ 1178 Fiscal Year 2008 SCHIP Allotments (CMS-2262-N)........................................ 0938-AO76 ---------------------------------------------------------------------------------------------------------------- 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 ---------------------------------------------------------------------------------------------------------------- 1179 End Stage Renal Disease (ESRD) Conditions for Coverage (CMS-3818-F) (Section 610 0938-AG82 Review)............................................................................... 1180 Hospital Conditions of Participation: Requirements for Approval and Reapproval of 0938-AH17 Transplant Centers To Perform Organ Transplants (CMS-3835-F).......................... 1181 Hospice Care Conditions of Participation (CMS-3844-F) (Section 610 Review)............ 0938-AH27 1182 Electronic Claims Attachments Standards (CMS-0050-F).................................. 0938-AK62 1183 Health Coverage Portability: Tolling Certain Time Periods and Interactions With Family 0938-AL88 and Medical Leave Act (CMS-2158-F).................................................... 1184 Revisions to the Appeals Process for Initial Claim Determinations (CMS-4064-F)........ 0938-AM73 1185 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)................................................... [[Page 73204]] 1186 Prior Determination Process for Certain Items and Services (CMS-6024-F)............... 0938-AN10 1187 Medicare Secondary Payer Amendments (CMS-6272-F)...................................... 0938-AN27 1188 Termination of Non-Random Prepayment Medical Review (CMS-6022-F)...................... 0938-AN31 1189 Limitation on Recoupment of Overpayments (CMS-6025-F)................................. 0938-AN42 1190 Medicare Part B Competitive Acquisition of Outpatient Drugs and Biologicals (CMS-1325- 0938-AN58 F).................................................................................... 1191 Medicare Integrity Program, Fiscal Intermediary and Carrier Functions, and Conflict of 0938-AN72 Interest Requirements (CMS-6030-F).................................................... 1192 Payment Error Rate Measurement (PERM) Program (CMS-6026-F)............................ 0938-AN77 1193 Notification Procedures for Hospital Discharges (CMS-4105-F).......................... 0938-AO41 1194 Identification of Backward Compatible Version of Adopted Standard for E-Prescribing 0938-AO42 and the Medicare Prescription Drug Program (Version 8.1) (CMS-0018-F)................. 1195 Prohibition of Mid-year Benefit Enhancements for Medicare Advantage Organizations 0938-AO54 Offering Plans in Calendar Year 2007 and Subsequent Calendar Years (CMS-4121-F)....... ---------------------------------------------------------------------------------------------------------------- Centers for Medicare & Medicaid Services--Completed Actions ---------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Number Number ---------------------------------------------------------------------------------------------------------------- 1196 Requirements for Providers and Suppliers To Establish and Maintain Medicare Enrollment 0938-AH73 (CMS-6002-F2)......................................................................... 1197 Organ Procurement Organization Conditions for Coverage and Recertification (CMS-3064- 0938-AK81 F) (Completion of a Section 610 Review)............................................... 1198 Fire Safety Requirements for Certain Health Care Facilities; Alcohol-Based Hand 0938-AN36 Sanitizer Amendment (CMS-3145-F)...................................................... 1199 Revisions to the Oversight and Validation Program for Accrediting Organizations 0938-AN62 Approved for Deeming Authority (CMS-2255-P)........................................... 1200 Physicians' Referrals to Health Care Entities With Which They Have Financial 0938-AN69 Relationships; E-Prescribing Exceptions (CMS-1303-F).................................. 1201 Home Health Payment System Rate Update for CY 2007 and Deficit Reduction Act of 2005 0938-AN76 Changes to Medicare Payment for Oxygen Equipment and Capped Rental Durable Medical Equipment (CMS-1304-F)................................................................ 1202 Inpatient Psychiatric Facility Prospective Payment System--Update for RY 2007 (CMS- 0938-AN82 1306-F)............................................................................... 1203 Innovations in Fee-for-Service Payment Systems to Improve Quality and Outcomes (CMS- 0938-AN91 1298-ANPR)............................................................................ 1204 Health Care Infrastructure Improvement Program; Loan Program for Qualifying Hospitals 0938-AO03 Engaged in Cancer-Related Health Care (CMS-1287-F).................................... 1205 Prospective Payment System for Long-Term Care Hospitals RY 2007: Annual Payment Rate 0938-AO06 Updates (CMS-1485-F).................................................................. 1206 Quality Standards for Genetic Testing (CMS-2121-P).................................... 0938-AO09 1207 Revisions to the Payment Policies of Ambulance Services Under the Fee Schedule for 0938-AO11 Ambulance Services (CMS-1317-F)....................................................... 1208 Hospital Inpatient Prospective Payment Systems and Fiscal Year 2007 Rates: Final 0938-AO12 Fiscal Year 2007 Wage Indices and Payment Rates After Application of Revised Occupational Mix Adjustment (CMS-1488-N).............................................. 1209 Changes to the Hospital Outpatient Prospective Payment System and CY 2007 Payment 0938-AO15 Rates; and Changes to the ASC Payment System in CY 2007 (CMS-1506-F).................. 1210 Prospective Payment System for Inpatient Rehabilitation Facilities for FY 2007, 0938-AO16 Certain Provisions Concerning Competitive Acquisition for DMEPOS (CMS-1540-F)......... 1211 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)......................... 1212 Inpatient Hospital Deductible and Hospital and Extended Care Services Coinsurance 0938-AO19 Amounts for Calendar Year 2007 (CMS-8029-N)........................................... 1213 Fiscal Year 2007 SCHIP Allotments (CMS-2251-N)........................................ 0938-AO21 1214 Five-Year Review of Work Relative Value Units Under the Physician Fee Schedule (CMS- 0938-AO22 1512-PN).............................................................................. 1215 Part B Monthly Actuarial Rates and Premium Rates Beginning January 1, 2007 (CMS-8030- 0938-AO23 N).................................................................................... 1216 Revisions to Payment Policies under the Physician Fee Schedule and Ambulance Fee 0938-AO24 Schedule for Calendar Year 2007 (CMS-1321-FC)......................................... 1217 Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities-- 0938-AO25 Update for FY 2007 (CMS-1530-N)....................................................... 1218 Hospice Wage Index for FY 2007 (CMS-1535-N)........................................... 0938-AO26 [[Page 73205]] 1219 State Allotments for Payment of Medicare Part B Premiums for Qualifying Individuals: 0938-AO31 Fiscal Year 2006 (CMS-2231-F)......................................................... 1220 Provider Nomination Provision (CMS-1331-P)............................................ 0938-AO33 1221 Extending Sunset Date for the Interim Final Regulation on Mental Health Parity (CMS- 0938-AO36 4094-F4).............................................................................. 1222 State Health Insurance Assistance Program (SHIP) (CMS-4005-F)......................... 0938-AO37 1223 State Children's Health Insurance Program (SCHIP) Redistribution of Unexpended SCHIP 0938-AO38 Funds From the Appropriation for Fiscal Year 2003 (CMS-2235-NC)....................... 1224 Fee Schedule for Payment of Ambulance Services--Update for CY 2007 (CMS-1532-N)....... 0938-AO39 1225 Fiscal Year Disproportionate Share Hospital Allotments and Disproportionate Share 0938-AO75 Hospital Institutions for Mental Disease Limits (CMS-2243-N).......................... ---------------------------------------------------------------------------------------------------------------- Administration for Children and Families--Proposed Rule Stage ---------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Number Number ---------------------------------------------------------------------------------------------------------------- 1226 Developmental Disabilities and Bill of Rights Act..................................... 0970-AC07 1227 Care and Placement of Unaccompanied Alien Children.................................... 0970-AC20 1228 Medical Support....................................................................... 0970-AC22 1229 Adoption and Foster Care Analysis and Reporting System................................ 0970-AC23 1230 Child Support Provisions of the Deficit Reduction Act................................. 0970-AC24 1231 Privatizing Functions................................................................. 0970-AC25 1232 Limitation on Use of Funds Made Available To Monitor and Combat Trafficking in Persons 0970-AC28 1233 Child Care and Development Fund Error Rate............................................ 0970-AC29 1234 Abstinence Education.................................................................. 0970-AC30 ---------------------------------------------------------------------------------------------------------------- Administration for Children and Families--Final Rule Stage ---------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Number Number ---------------------------------------------------------------------------------------------------------------- 1235 Safeguarding Child Support and Expanded Federal Parent Locator Services (FPLS) 0970-AC01 Information........................................................................... 1236 Cost Allocation Methodology Applicable to the Temporary Assistance for Needy Families 0970-AC15 Program............................................................................... 1237 Child Care and Development Fund State Match Provisions................................ 0970-AC18 1238 Chafee National Youth in Transition Database.......................................... 0970-AC21 1239 Head Start Transportation............................................................. 0970-AC26 1240 TANF Work Provisions of the Deficit Reduction Act..................................... 0970-AC27 ---------------------------------------------------------------------------------------------------------------- Administration for Children and Families--Completed Actions ---------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Number Number ---------------------------------------------------------------------------------------------------------------- 1241 Reasonable Quantitative Standard for Review and Adjustment of Child Support Orders.... 0970-AC19 ---------------------------------------------------------------------------------------------------------------- [[Page 73206]] _______________________________________________________________________ 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''; date 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 03/00/07 NPRM Comment Period End 05/00/07 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 _______________________________________________________________________ Department of Health and Human Services (HHS) Final Rule Stage Office of the Secretary (OS) _______________________________________________________________________ 986. SHARED RISK EXCEPTION TO THE SAFE HARBOR PROVISIONS Priority: Substantive, Nonsignificant Legal Authority: 42 USC 1302; 42 USC 1320a-7b; 42 USC 1395hh; PL 104- 191, sec 216(b) CFR Citation: 42 CFR 1001 Legal Deadline: Final, Statutory, January 1, 1997. Abstract: This final rule establishes a new statutory exception for risk-sharing arrangements under the Federal health care programs' anti- kickback provisions. The rule sets forth an exception from liability for remuneration between an eligible organization and an individual or entity providing items or services in accordance with a written agreement between these parties. The rule allows remuneration between an organization and an individual or entity if a written agreement places the individual or entity at ``substantial financial risk'' for the cost or utilization of the items or services that the individual or entity is obligated to provide. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ ANPRM 05/23/97 62 FR 28410 ANPRM Comment Period End 06/09/97 Interim Final Rule 11/19/99 64 FR 63504 Final Action 04/00/07 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 _______________________________________________________________________ 987. SAFE HARBOR FOR WAIVER OF BENEFICIARY COINSURANCE AND DEDUCTIBLE AMOUNTS FOR A MEDICARE SELECT POLICY Priority: Substantive, Nonsignificant Legal Authority: PL 100-93, sec 14(a) CFR Citation: 42 CFR 1001 Legal Deadline: None Abstract: This final rule will expand the existing safe harbor for certain waivers of beneficiary coinsurance and deductible amounts to benefit the policyholders of Medicare SELECT supplemental insurance. Specifically, the amended safe harbor will protect waivers of coinsurance and deductible amounts under part A or part B of the Medicare program owed by beneficiaries covered by a Medicare SELECT policy issued in accordance with section 1882(t)(1) of the Social Security Act, if the waiver is in accordance with a price reduction agreement covering such policyholders between the Medicare SELECT issuer and the provider or supplier offering the waiver. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 09/25/02 67 FR 60202 NPRM Comment Period End 10/25/02 Final Action 04/00/07 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 _______________________________________________________________________ 988. DEBT 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 [[Page 73207]] 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 01/00/07 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, HHS Cohen Building, Room 4760, 330 Independence Avenue SW., Washington, DC 20201 Phone: 202 619-0150 RIN: 0991-AB18 _______________________________________________________________________ 989. SALARY OFFSET Priority: Substantive, Nonsignificant Unfunded Mandates: Undetermined Legal Authority: 5 USC 5514 CFR Citation: 5 CFR 550; 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 69 FR 42022 Final Action 01/00/07 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, HHS Cohen Building, Room 4760, 330 Independence Avenue SW., Washington, DC 20201 Phone: 202 619-0150 RIN: 0991-AB19 _______________________________________________________________________ 990. 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 04/00/07 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 _______________________________________________________________________ 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 12/00/06 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 [[Page 73208]] _______________________________________________________________________ Department of Health and Human Services (HHS) Long-Term Actions Office of the Secretary (OS) _______________________________________________________________________ 992. 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 ________________________________________________________________________ Final Action To Be Determined Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: Federal Agency Contact: Joel Jay Schaer, Regulations Officer, Department of Health and Human Services, Office of the Secretary, Office of Inspector General, 330 Independence Avenue SW., Washington, DC 20201 Phone: 202 619-0089 RIN: 0991-AB33 _______________________________________________________________________ Department of Health and Human Services (HHS) Completed Actions Office of the Secretary (OS) _______________________________________________________________________ 993. MEDICARE AND STATE HEALTH CARE PROGRAMS: FRAUD AND ABUSE; SAFE HARBOR FOR CERTAIN ELECTRONIC PRESCRIBING ARRANGEMENTS UNDER THE ANTI- KICKBACK STATUTE Priority: Other Significant CFR Citation: 42 CFR 1001 Completed: ________________________________________________________________________ Reason Date FR Cite ________________________________________________________________________ Final Action 08/08/06 71 FR 45110 Regulatory Flexibility Analysis Required: No Government Levels Affected: None Agency Contact: Joel Jay Schaer Phone: 202 619-0089 RIN: 0991-AB39 _______________________________________________________________________ Department of Health and Human Services (HHS) Proposed Rule Stage Substance Abuse and Mental Health Services Administration (SAMHSA) _______________________________________________________________________ 994. REQUIREMENTS GOVERNING THE USE OF SECLUSION AND RESTRAINT IN CERTAIN NONMEDICAL COMMUNITY-BASED FACILITIES FOR CHILDREN AND YOUTH Priority: Other Significant. Major status under 5 USC 801 is undetermined. Legal Authority: PL 106-310 CFR Citation: Not Yet Determined Legal Deadline: NPRM, Statutory, April 2001. Abstract: The Secretary is required by statute to publish regulations governing States that license nonmedical, community-based residential facilities for children and youth. The regulation requires States to develop licensing rules and monitoring requirements concerning behavior management practice that will ensure compliance; requires States to develop and implement such licensing rules and implementation requirements within one year; and ensures that States require such facilities to have adequate staff, and that the States provide training for professional staff. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 06/00/07 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) _______________________________________________________________________ 995. 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. [[Page 73209]] Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Notice 04/13/04 69 FR 19673 Final Action 06/00/07 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, 5600 Fishers Lane, Rockville, MD 20857 Phone: 301 443-7017 Fax: 301 443-1450 Email: jfaha@samhsa.gov RIN: 0930-AA12 _______________________________________________________________________ Department of Health and Human Services (HHS) Prerule Stage Centers for Disease Control and Prevention (CDC) _______________________________________________________________________ 996. FOREIGN QUARANTINE REGULATIONS, PROPOSED REVISION OF HHS/CDC ANIMAL IMPORTATION REGULATIONS Priority: Other Significant. Major status under 5 USC 801 is undetermined. Unfunded Mandates: Undetermined Legal Authority: Not Yet Determined CFR Citation: 42 CFR 71 Legal Deadline: None Abstract: The Centers for Disease Control and Prevention (CDC) is issuing this Advance Notice of Proposed Rulemaking (ANPRM) to begin the process of revising the regulations for importation of dogs, cats and other animals into the United States (42 CFR 71.51 and 71.56). The input received from stakeholders via the ANPRM with the aim of improving CDC's ability to prevent importation of communicable diseases. The scope of this ANPRM does not include the nonhuman primate regulations (42 CFR 71.53). Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ ANPRM 12/00/06 Regulatory Flexibility Analysis Required: Undetermined Government Levels Affected: None Federalism: Undetermined Agency Contact: Jennifer Brooks, Department of Health and Human Services, Centers for Disease Control and Prevention, National Center for Infectious Diseases, 1600 Clifton Road NE., NE E-03, Atlanta, GA 30333 Phone: 404 639-7048 RIN: 0920-AA14 _______________________________________________________________________ 997. AMENDMENTS TO POWERED AIR-PURIFYING RESPIRATOR REQUIREMENTS FOR APPROVAL OF RESPIRATORY PROTECTION DEVICES Priority: Other Significant. Major status under 5 USC 801 is undetermined. Unfunded Mandates: Undetermined Legal Authority: 28 USC 651; 30 USC 3; 30 USC 7; 30 USC 11; 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 powered air-purifying respirators. These respirators are used in a variety of workplace applications, including emergency response activities. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ ANPRM 03/00/07 Regulatory Flexibility Analysis Required: Undetermined Government Levels Affected: None Federalism: Undetermined 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, P.O. Box 18070, 626 Cochrans Mill Road, Pittsburgh, PA 15236 Phone: 412 386-5200 RIN: 0920-AA16 _______________________________________________________________________ 998. AMENDMENTS TO PERFORMANCE REQUIREMENTS FOR CHEMICAL BIOLOGICAL, RADIOLOGICAL, AND NUCLEAR (CBRN) APPROVAL OF RESPIRATORY PROTECTION DEVICES Priority: Other Significant. Major status under 5 USC 801 is undetermined. Legal Authority: 29 USC 651; 30 USC 3; 30 USC 5; 30 USC 7; 30 USC 11; 30 USC 842l; 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, supplied air respirators, and combination (supplied air and air purifying capable) respirators against CBRN respiratory hazards. These respirators are used in emergency response situations. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ ANPRM 03/00/07 Regulatory Flexibility Analysis Required: Undetermined Small Entities Affected: Businesses Government Levels Affected: None Federalism: Undetermined 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, P.O. Box 18070, 626 Cochrans Mill Road, Pittsburgh, PA 15236 Phone: 412 386-5200 RIN: 0920-AA17 [[Page 73210]] _______________________________________________________________________ Department of Health and Human Services (HHS) Proposed Rule Stage Centers for Disease Control and Prevention (CDC) _______________________________________________________________________ 999. 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 12/00/06 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, P.O. Box 18070, 626 Cochrans Mill Road, Pittsburgh, PA 15236 Phone: 412 386-5200 RIN: 0920-AA04 _______________________________________________________________________ 1000. 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 12/00/06 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, P.O. Box 18070, 626 Cochrans Mill Road, Pittsburgh, PA 15236 Phone: 412 386-5200 RIN: 0920-AA10 _______________________________________________________________________ 1001. AMENDMENTS TO REQUIREMENTS FOR COAL MINE DUST PERSONAL SAMPLER UNITS Priority: Other Significant. Major status under 5 USC 801 is undetermined. Unfunded Mandates: Undetermined Legal Authority: Not Yet Determined CFR Citation: Not Yet Determined Legal Deadline: None Abstract: NIOSH and MSHA jointly plan to modify 30 CFR part 74, which provides requirements for the approval by NIOSH and MSHA or coal mine dust personal sampler units that are worn by miners to determine the concentrations of respirable dust in coal mine atmospheres. The existing requirements are design-specific for a particular monitoring technology that has been available since the 1970's. The amendments would establish requirements that would promote the development and govern the testing and approval of new coal mine dust sampler designs and technology for use in coal mines. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 12/00/06 Regulatory Flexibility Analysis Required: Undetermined Small Entities Affected: Businesses Government Levels Affected: None Federalism: Undetermined Agency Contact: John Breslin, Director, Science, Pittsburgh Research Laboratory, Department of Health and Human Services, Centers for Disease Control and Prevention, 626 Cochrans Mill Road, Pittsburgh, PA 15236 Phone: 412 386-6873 RIN: 0920-AA18 _______________________________________________________________________ Department of Health and Human Services (HHS) Final Rule Stage Centers for Disease Control and Prevention (CDC) _______________________________________________________________________ 1002. CONTROL OF COMMUNICABLE DISEASES, INTERSTATE AND FOREIGN QUARANTINE Regulatory Plan: This entry is Seq. No. 35 in part II of this issue of the Federal Register. RIN: 0920-AA12 _______________________________________________________________________ 1003. 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 [[Page 73211]] 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, Public Law No. 108-375 (codified as amended in scattered sections of 42 U.S.C.). Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Interim Final Rule 12/22/05 70 FR 75949 Interim Final Rule Comment Period End 02/21/06 Final Action 01/00/07 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, 4676 Columbia Pkwy, MS C-46, Cincinnati, OH 45226 Phone: 513 533-6825 RIN: 0920-AA13 _______________________________________________________________________ 1004. [bull] INTERSTATE SHIPMENT OF ETIOLOGIC AGENTS Priority: Other Significant Legal Authority: Not Yet Determined CFR Citation: 42 CFR 72 Legal Deadline: None Abstract: HHS/CDC proposes to rescind part 72 of title 42, Code of Federal Regulations, which governs the interstate shipment of etiologic agents, because the U.S. Department of Transportation (DOT) already has in effect a more comprehensive set of regulations applicable to the transport in commerce of infectious substances. DOT harmonizes its transport requirements with international standards adopted by the United Nations (UN) Committee of Experts on the Transport of Dangerous Goods for the classification, packaging, and transport of infectious substances. Rescinding the rule will eliminate duplication of the more current DOT regulations that cover intrastate and international, as well as interstate, transport. HHS/CDC replaced those sections of part 72 that deal with select biological agents and toxins with a new set of regulations found in part 73 of title 42. HHS/CDC anticipates that rescission of part 72 will alleviate confusion and reduce the regulatory burden with no adverse impact on public health and safety. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Interim Final Rule 12/00/06 Regulatory Flexibility Analysis Required: No Government Levels Affected: None Agency Contact: Janet K Nicholson, Associate Director-Lab Science, Department of Health and Human Services, Centers for Disease Control and Prevention, Clifton Bldg. 16, Room 5131, Atlanta, GA 30329-4018 Phone: 404 639-3945 RIN: 0920-AA19 _______________________________________________________________________ Department of Health and Human Services (HHS) Prerule Stage Food and Drug Administration (FDA) _______________________________________________________________________ 1005. 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 sunscreen 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 ________________________________________________________________________ NPRM (UVA/UVB) 12/00/06 ANPRM (Sunscreen and Insect Repellent) 12/00/06 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: Local, State Federalism: This action may have federalism implications as defined in EO 13132. 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: gerald.rachanow@fda.hhs.gov Related RIN: Split from 0910-AA01 RIN: 0910-AF43 _______________________________________________________________________ 1006. 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 is soliciting 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 [[Page 73212]] conflicts with other Federal, State, or local 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 04/01/06 End Review of Current Regulation12/00/06 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, PI50 RM150F, Rockville, MD 20850 Phone: 240 276-2347 Fax: 240 276-2352 Email: myrna.hanna@fda.hhs.gov RIN: 0910-AF71 _______________________________________________________________________ 1007. PACKAGE SIZE LIMITATION FOR SODIUM PHOSPHATES ORAL SOLUTION AND WARNING AND DIRECTION STATEMENTS FOR ORAL AND RECTAL SODIUM PHOSPHATES FOR OVER-THE-COUNTER LAXATIVE USE (SECTION 610 REVIEW) Priority: Routine and Frequent. Major status under 5 USC 801 is undetermined. Legal Authority: 5 USC 610 CFR Citation: 21 CFR 201.307 Legal Deadline: None Abstract: Section 201.307 (21 CFR section 201.307) describes a final rule to limit the container size for sodium phosphates oral solution (dibasic sodium phosphate/monobasic sodium phosphate oral solution) to not greater than 90 milliliters (mL) (3 ounces (oz)) when used as an over-the-counter (OTC) laxative drug product. FDA limited the container size due to reports of deaths associated with an overdosage of sodium phosphates when packaged in a larger size container and a larger than intended dose was ingested inadvertently. In addition, this final rule required warning and direction statements to inform consumers that exceeding the recommended dose of oral and rectal sodium phosphates products in a 24 hour period could be harmful. FDA is initiating a review under section 610 of the Regulatory Flexibility Act for the regulation in section 201.307. The purpose of this review is to determine whether the regulation in section 201.307 should be continued without change, or whether it 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 soliciting comments on the following: (1) The continued need for the regulation in section 201.307; (2) the nature of the complaints or comments received concerning the regulation in section 201.307; (3) the complexity of the regulation in section 201.307; (4) the extent to which the regulation in section 201.307 overlaps, duplicates, or conflicts 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 package size and labeling regulation in section 201.307. 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. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Begin Review of Current Regulation 12/00/06 End Review 12/00/07 Regulatory Flexibility Analysis Required: No Government Levels Affected: Local, State Federalism: This action may have federalism implications as defined in EO 13132. Agency Contact: Walter Ellenberg, Regulatory Project Management Officer, Center for Drug Evaluation and Research, Department of Health and Human Services, Food and Drug Administration, WO22 RM 5489, HFD- 569, Rockville, MD 20850 Phone: 301 796-0885 Fax: 301 796-9899 Email: walter.ellenberg@fda.hhs.gov RIN: 0910-AF73 _______________________________________________________________________ 1008. OVER-THE-COUNTER DRUG PRODUCTS CONTAINING ANALGESIC/ANTIPYRETIC ACTIVE INGREDIENTS FOR INTERNAL USE: REQUIRED ALCOHOL WARNING (SECTION 610 REVIEW) Priority: Routine and Frequent. Major status under 5 USC 801 is undetermined. Legal Authority: 5 USC 610 CFR Citation: 21 CFR 201.322 Legal Deadline: None Abstract: Section 201.322 describes a regulation which requires an alcohol warning for all over-the-counter (OTC) drug products, labeled for adult use, containing internal analgesic/antipyretic active ingredients. The required warning statements advise consumers with a history of heavy alcohol use to consult a physician for advice about the use of OTC internal analgesic/antipyretic drug products. FDA issued the final rule after considering comments on the Agency's proposed regulation for OTC internal analgesic, antipyretic, and antirheumatic drug products: A proposed regulation to establish an alcohol warning; recommendations from its Nonprescription Drugs Advisory Committee (NDAC) and Arthritis Drugs Advisory Committee (ADAC); and data submitted to the agency. FDA is initiating a review under section 610 of the Regulatory Flexibility Act for the regulation in section 201.322. The purpose of this review is to determine whether the regulation in section 201.322 should be continued without change, or whether it 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 soliciting comments on the following: (1) The continued need for the regulation in section 201.322; (2) the nature of the complaints or comments received concerning the regulation in section 201.322; (3) the [[Page 73213]] complexity of the regulation in section 201.322; (4) the extent to which the regulation in section 201.322 overlaps, duplicates, or conflicts 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 labeling regulation in section 201.322. 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. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Begin Review of Current Regulation 12/00/06 End Review 12/00/07 Regulatory Flexibility Analysis Required: No Government Levels Affected: Local, State Federalism: This action may have federalism implications as defined in EO 13132. Agency Contact: Walter Ellenberg, Regulatory Project Management Officer, Center for Drug Evaluation and Research, Department of Health and Human Services, Food and Drug Administration, WO22 RM 5489, HFD- 569, Rockville, MD 20850 Phone: 301 796-0885 Fax: 301 796-9899 Email: walter.ellenberg@fda.hhs.gov RIN: 0910-AF74 _______________________________________________________________________ 1009. STATUS OF CERTAIN ADDITIONAL OVER-THE-COUNTER DRUG CATEGORY II AND III ACTIVE INGREDIENTS (SECTION 610 REVIEW) Priority: Routine and Frequent. Major status under 5 USC 801 is undetermined. Legal Authority: 5 USC 610 CFR Citation: 21 CFR 310.545 Legal Deadline: None Abstract: Section 310.545 (21 CFR 310.545) codifies a final rule that was issued stating certain first aid antiseptic, vaginal contraceptive, and antimicrobial diaper rash ingredients in over-the-counter (OTC) drug products are not generally recognized as safe and effective and are misbranded. This rule took into consideration the reports and recommendations of various OTC drug advisory review panels and public comment on proposed Agency regulations. Based on the absence of substantive comments in opposition to the Agency's proposed nonmonograph status for various ingredients, as well as the failure of interested parties to submit new data or information to FDA, the Agency determined that the presence of the subject ingredients in an OTC drug products would result in that product not being generally recognized as safe and effective and would result in misbranding. FDA is initiating a review under section 610 of the Regulatory Flexibility Act for the regulation in section 310.545. The purpose of this review is to determine whether the regulation in section 310.545 should be continued without change, or whether it 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 soliciting comments on the following: (1) The continued need for the regulation in section 310.545; (2) the nature of the complaints or comments received concerning the regulation in section 310.545; (3) the complexity of the regulations in section 310.545; (4) the extent to which the regulation in section 310.545 overlaps, duplicates, or conflicts 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 regulation in section 310.545. 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. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Begin Review of Current Regulation 12/00/06 End Review 12/00/07 Regulatory Flexibility Analysis Required: No Government Levels Affected: Local, State Federalism: This action may have federalism implications as defined in EO 13132. Agency Contact: Walter Ellenberg, Regulatory Project Management Officer, Center for Drug Evaluation and Research, Department of Health and Human Services, Food and Drug Administration, WO22 RM 5489, HFD- 569, Rockville, MD 20850 Phone: 301 796-0885 Fax: 301 796-9899 Email: walter.ellenberg@fda.hhs.gov RIN: 0910-AF75 _______________________________________________________________________ 1010. MEDICAL DEVICES: CLASSIFICATION/RECLASSIFICATION; RESTRICTED DEVICES; ANALYTE SPECIFIC REAGENTS (SECTION 610 REVIEW) Priority: Other Significant Legal Authority: 21 USC 351; 21 USC 352; 21 USC 360j CFR Citation: 21 CFR 809.10; 21 CFR 809.30 Legal Deadline: None Abstract: FDA is initiating a review under section 610 of the Regulatory Flexibility Act for two regulations in part 809. The purpose of this review is to determine if 21 CFR 809.10 and 809.30 should be continued without change, or should be amended or rescinded, to minimize adverse economic impact on small entities. FDA is soliciting and will consider comments on the following: 1) The continued need for 21 CFR 809.10 and 809.30; 2) the nature of complaints or comments received concerning 21 CFR 809.10 and 809.30; 3) the complexity of 21 CFR 809.10 and 809.30; 4) the extent to which 21 CFR 809.10 and 809.30 overlap, duplicate, or conflict with other Federal, State, or local government rules; and 5) the degree to which technology economic conditions or other factors have changed in the area affected by 21 CFR 809.10 and 809.30. [[Page 73214]] Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Begin Review of Current Regulation 12/00/06 End Review of Current Regulation11/00/07 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Myrna Hanna, Regulations Staff, Department of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health, HFZ-215, 1350 Piccard Drive, PI50 RM150F, Rockville, MD 20850 Phone: 240 276-2347 Fax: 240 276-2352 Email: myrna.hanna@fda.hhs.gov RIN: 0910-AF76 _______________________________________________________________________ 1011. AMENDED ECONOMIC IMPACT ANALYSIS OF FINAL RULE ON USER LABELING ON NATURAL RUBBER-CONTAINING MEDICAL DEVICE (SECTION 610 REVIEW) Priority: Other Significant. Major status under 5 USC 801 is undetermined. Legal Authority: 21 USC 321; 21 USC 331; 21 USC 351; 21 USC 352; 21 USC 357; 21 USC 360i; 21 USC 360j; 21 USC 371; 21 USC 374 CFR Citation: 21 CFR 801.437 Legal Deadline: Other, Statutory, September 30, 2007, Planned Section 610 Review. Abstract: FDA is initiating a review of the regulations in part 801 under section 610 of the Regulatory Flexibility Act. The purpose of this review is to determine, consistent with stated objectives and applicable statutes, whether the regulations in part 801 should be continued without change, amended, or rescinded in order to minimize any significant economic impact on a substantial number of small entities. FDA will consider and is soliciting comments on the following: 1) The continued need for the regulation; 2) the nature of complaints or comments received concerning the regulation; 3) the complexity of the regulation; 4) the extent to which a regulation in part 801 overlaps, duplicates, or conflicts with other Federal rules, and to the extent feasible, with State and local government rules; and 5) the degree to which technology, economic conditions, or other factors have changed in the area affected by the regulation. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Final Action 09/30/97 62 FR 51021 Final Action Effective 09/30/98 End Review of Current Regulation12/00/06 Regulatory Flexibility Analysis Required: No Government Levels Affected: None Agency Contact: Myrna Hanna, Regulations Staff, Department of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health, HFZ-215, 1350 Piccard Drive, PI50 RM150F, Rockville, MD 20850 Phone: 240 276-2347 Fax: 240 276-2352 Email: myrna.hanna@fda.hhs.gov RIN: 0910-AF77 _______________________________________________________________________ 1012. FINANCIAL DISCLOSURE BY CLINICAL INVESTIGATORS (SECTION 610 REVIEW) Priority: Other Significant. Major status under 5 USC 801 is undetermined. Legal Authority: 21 USC 321; 21 USC 331; 21 USC 351; 21 USC 352; 21 USC 353; 21 USC 355; 21 USC 356; 21 USC 357; 21 USC 360; 21 USC 360c to 360j; 21 USC 371; 21 USC 372; 21 USC 373; 21 USC 374; 21 USC 375; 21 USC 376; 21 USC 379; 42 USC 262 CFR Citation: 21 CFR 54; 21 CFR 312.53; 21 CFR 312.57; 21 CFR 312.64; 21 CFR 314.50; 21 CFR 314.60; 21 CFR 314.94; 21 CFR 314.200; 21 CFR 314.300; 21 CFR 320.36; 21 CFR 330.10; 21 CFR 601.2; 21 CFR 807.31; 21 CFR 807.87; 21 CFR 807.100; 21 CFR 812.43; 21 CFR 812.110; 21 CFR 812.140; 21 CFR 814.20; 21 CFR 814.42; 21 CFR 814.112; 21 CFR 860.123 Legal Deadline: Other, Statutory, February 2, 2006, Planned Section 610 Review. Abstract: FDA is undertaking a review of 21 CFR sections 54, 312.53, 312.47, 312.64, 314.50, 314.60, 314.94, 314.200, 314.300, 320.36, 330.10, 601.2, 807.31, 807.87, 807.100, 812.43, 812.110, 812.140, 814.20, 814.42, 814.112 and 860.123 under section 610 of the Regulatory Flexibility Act. The purpose of this review is to determine whether the regulations in sections 54, 312.53, 312.47, 312.64, 314.50, 314.60, 314.94, 314.200, 314.300, 320.36, 330.10, 601.2, 807.31, 807.87, 807.100, 812.43, 812.110, 812.140, 814.20, 814.42, 814.112 and 860.123 should be continued without change, or whether they should be amended or rescinded, consistent with the stated objectives of applicable statues, to minimize adverse impacts on a substantial number of small entities. FDA will consider, and is soliciting comments on, the following: (1) The continued need for the regulations in sections 54, 312.53, 312.47, 312.64, 314.50, 314.60, 314.94, 314.200, 314.300, 320.36, 330.10, 601.2, 807.31, 807.87, 807.100, 812.43, 812.110, 812.140, 814.20, 814.42, 814.112 and 860.123; (2) the nature of complaints or comments received concerning the regulations in sections 54, 312.53, 312.47, 312.64, 314.50, 314.60, 314.94, 314.200, 314.300, 320.36, 330.10, 601.2, 807.31, 807.87, 807.100, 812.43, 812.110, 812.140, 814.20, 814.42, 814.112 and 860.123; (3) the complexity of the regulations in sections 54, 312.53, 312.47, 312.64, 314.50, 314.60, 314.94, 314.200, 314.300, 320.36, 330.10, 601.2, 807.31, 807.87, 807.100, 812.43, 812.110, 812.140, 814.20, 814.42, 814.112 and 860.123; (4) the extent to which the regulations in sections 54, 312.53, 312.47, 312.64, 314.50, 314.60, 314.94, 314.200, 314.300, 320.36, 330.10, 601.2, 807.31, 807.87, 807.100, 812.43, 812.110, 812.140, 814.20, 814.42, 814.112 and 860.123 overlap, duplicate, or conflict with other regulations with other Federal, State, or governmental rules, and (5) the degree to which technology, economic conditions, or other factors have changed in the area affected by the regulations in sections 54, 312.53, 312.47, 312.64, 314.50, 314.60, 314.94, 314.200, 314.300, 320.36, 330.10, 601.2, 807.31, 807.87, 807.100, 812.43, 812.110, 812.140, 814.20, 814.42, 814.112 and 860.123. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Begin Review of Current Regulation 12/00/06 End Review of Current Regulation12/00/07 Regulatory Flexibility Analysis Required: No Government Levels Affected: None [[Page 73215]] 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: howard.mullerjr@fda.hhs.gov Stephen M. Ripley, Team Leader, Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research, Suite 200N, HFM-17, 1401 Rockville Pike, Rockville, MD 20852-1448 Phone: 301 827-6210 Fax: 301 827-9434 Elisa D. Harvey, Director, Office of Device Evaluation, Department of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health, 1350 Piccard Drive (HFZ-215), Corp Rm 130F, Rockville, MD 20850 Phone: 301 594-1190 Fax: 301 594-3076 Email: elisa.harvey@fda.hhs.gov RIN: 0910-AF79 _______________________________________________________________________ 1013. BEVERAGES: BOTTLED WATER (SECTION 610 REVIEW) Priority: Substantive, Nonsignificant. Major status under 5 USC 801 is undetermined. Unfunded Mandates: Undetermined Legal Authority: 21 USC 321; 21 USC 341; 21 USC 343; 21 USC 343-1; 21 USC 348; 21 USC 349; 21 USC 371; 21 USC 379e CFR Citation: 21 CFR 165.110 Legal Deadline: Other, Statutory, November 13, 2005, Planned Section 610 Review. Abstract: Section 165.110 (21 CFR 165.110) describes requirements for identity and quality standards for bottled water. FDA is undertaking a review of section 165.110 under section 610 of the Regulatory Flexibility Act. The purpose of this review is to determine whether the regulations in section 165.110 should be continued without change, or whether they should be amended or rescinded, consistent with the stated objectives of applicable statutes, to minimize any significant economic impact on a substantial number of small entities. FDA will consider, and is soliciting comments on, the following: (1) The continued need for the regulations in section 165.110; (2) the nature of complaints or comments received concerning the regulations in section 165.110; (3) the complexity of the regulations; (4) the extent to which the regulations in section 165.110 overlap, duplicate, or conflict with other Federal rules, and to the extent feasible, with State, or governmental rules; and (5) the degree to which technology, economic conditions, or other factors have changed in the area affected by the regulations in section 165.110. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Begin Review 03/00/07 End Review 12/00/07 Regulatory Flexibility Analysis Required: Undetermined Government Levels Affected: Undetermined Federalism: Undetermined Agency Contact: Richard A. Williams, Director, Division of Social Sciences, ORP, 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@fda.hhs.gov RIN: 0910-AF80 _______________________________________________________________________ 1014. FOOD LABELING; NUTRIENT CONTENT CLAIMS: DEFINITION FOR ``HIGH POTENCY'' AND DEFINITION OF ``ANTIOXIDANT'' FOR USE IN NUTRIENT CONTENT CLAIMS FOR DIETARY SUPPLEMENTS AND CONVENTIONAL FOODS (SECTION 610 REVIEW) Priority: Other Significant. Major status under 5 USC 801 is undetermined. Legal Authority: 15 USC 1453; 15 USC 1454; 15 USC 1455; 21 USC 321; 21 USC 331; 21 USC 342; 21 USC 343; 21 USC 348; 21 USC 371 CFR Citation: 21 CFR 101.54; 21 CFR 101.60 Legal Deadline: Other, Statutory, September 23, 2007, Deadline for 610(c) Review. Abstract: Section 101.54 (21 CFR 101.54) describes the requirements for when the terms ``high potency'' and ``antioxidant'' may be used on the label or in the labeling of foods, including dietary supplements. Section 101.60 (21 CFR 101.60) describes the requirements for when the terms ``low calorie'' or ``reduced calorie'' may be used on the label or in the labeling of such foods. FDA is undertaking a review of sections 101.54 and 101.60 under section 610 of the Regulatory Flexibility Act. The purpose of this review is to determine whether the regulations should be continued without change, or whether they should be amended or rescinded, consistent with the stated objectives of applicable statutes, to minimize any significant economic impact on a substantial number of small entities. FDA will consider, and is soliciting comments on, the following: (1) The continued need for the regulations in sections 101.54 and 101.60; (2) the nature of complaints or comments received concerning the regulations; (3) the complexity of the regulations; (4) the extent to which the regulations in sections 101.54 and 101.60 overlap, duplicate, or conflict with other Federal rules, and to the extent feasible, with State, or governmental rules; and (5) the degree to which technology, economic conditions, or other factors have changed in the area affected by the regulations in sections 101.54 and 101.60. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Begin Review 12/00/06 End Review 09/00/07 Regulatory Flexibility Analysis Required: Undetermined Government Levels Affected: Federal, Local, State, Tribal Federalism: This action may have federalism implications as defined in EO 13132. Agency Contact: Richard A. Williams, Director, Division of Social Sciences, ORP, 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@fda.hhs.gov RIN: 0910-AF83 [[Page 73216]] _______________________________________________________________________ Department of Health and Human Services (HHS) Proposed Rule Stage Food and Drug Administration (FDA) _______________________________________________________________________ 1015. MEDICAL DEVICES; ANESTHESIOLOGY DEVICES; PROPOSED RECLASSIFICATION OF PRESSURE REGULATORS FOR USE WITH MEDICAL OXYGEN AND SEPARATE CLASSIFICATION OF OXYGEN CONSERVING DEVICES Priority: Routine and Frequent Legal Authority: 21 USC 351; 21 USC 352; 21 USC 360c; 21 USC 360i; 21 USC 371 CFR Citation: 21 CFR 868.2700; 21 CFR 868.2750 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, establish a separate classification for oxygen conserving devices, and establish a special control for these devices to address problems of fire and explosion associated with use of these devices. The special control would be a guidance document that includes standardized testing, performance, and labeling guidance for industry. Devices that meet the special control would be exempt from the premarket notification requirements of the Federal Food, Drug, and Cosmetic Act (the Act). The agency believes it is taking a least burdensome approach for industry. The requirements of the proposed rule would be phased-in to minimize the cost of complying with the special control. FDA seeks to reclassify these devices under section 513(e)(1) of the act (21 U.S.C. 360c(e)(1)). Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 12/00/06 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, PI50 RM150F, Rockville, MD 20850 Phone: 240 276-2347 Fax: 240 276-2352 Email: myrna.hanna@fda.hhs.gov RIN: 0910-AC30 _______________________________________________________________________ 1016. ELECTRONIC SUBMISSION OF DATA FROM STUDIES EVALUATING HUMAN DRUGS AND BIOLOGICS Regulatory Plan: This entry is Seq. No. 36 in part II of this issue of the Federal Register. RIN: 0910-AC52 _______________________________________________________________________ 1017. 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 16.1; 21 CFR 58.11; 21 CFR 58.12; 21 CFR 71.1; 21 CFR 101.69; 21 CFR 170.101; 21 CFR 171.1; 21 CFR 190.6; 21 CFR 312.3; 21 CFR 312.56; 21 CFR 511.1; 21 CFR 571.1; 21 CFR 812.46 Legal Deadline: None Abstract: The proposed rule would require sponsors to promptly report any information indicating that any person has or may have engaged in the falsification of data in the course of proposing, designing, performing, recording, supervising, or reviewing research, or in reporting research results. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 12/00/06 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: brian.pendleton@fda.hhs.gov Related RIN: Previously reported as 0910-AC02 RIN: 0910-AC59 _______________________________________________________________________ 1018. CONTENT AND FORMAT OF LABELING FOR HUMAN PRESCRIPTION DRUGS AND BIOLOGICS; REQUIREMENTS FOR PREGNANCY AND LACTATION LABELING Regulatory Plan: This entry is Seq. No. 37 in part II of this issue of the Federal Register. RIN: 0910-AF11 _______________________________________________________________________ 1019. 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 expanded access to investigational drugs for treatment use, 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 12/00/06 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, Center for Drug Evaluation and Research, 5515 Security Lane, Rockville, MD 20852 Phone: 301 594-2041 Fax: 301 827-5562 Email: christine.rogers@fda.hhs.gov RIN: 0910-AF13 [[Page 73217]] _______________________________________________________________________ 1020. EXPANDED ACCESS TO INVESTIGATIONAL DRUGS FOR TREATMENT USE Regulatory Plan: This entry is Seq. No. 38 in part II of this issue of the Federal Register. RIN: 0910-AF14 _______________________________________________________________________ 1021. 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 01/00/07 Regulatory Flexibility Analysis Required: No Small Entities Affected: Businesses Government Levels Affected: None Agency Contact: Kathleen G. Swisher, Supervisory Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research, HFM-17, 1401 Rockville Pike, Rockville, MD 20852-1448 Phone: 301 827-6210 Fax: 301 827-9434 Related RIN: Split from 0910-AB26 RIN: 0910-AF25 _______________________________________________________________________ 1022. 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 2 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. The Stevens Johnson and Cardiovascular Warnings Documents address new proposed product warnings. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM (Amendment) (Required Warnings and Other Labeling) 12/00/06 NPRM (Amendment) (Pediatric) 03/00/07 NPRM (Amendment) (Combinations with Sodium Bicarbonate) 06/00/07 NPRM (Amendment) (Cardiovascular Warnings) 06/00/07 NPRM (Amendment) (Overindulgence/ Hangover) 10/00/07 NPRM (Amendment) (Stevens Johnson Warnings) 10/00/07 Final Action (Internal Analgesics) 10/00/07 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: Local, State Federalism: This action may have federalism implications as defined in EO 13132. 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: gerald.rachanow@fda.hhs.gov Related RIN: Split from 0910-AA01 RIN: 0910-AF36 _______________________________________________________________________ 1023. 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 [[Page 73218]] 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) 12/00/06 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: Local, State Federalism: This action may have federalism implications as defined in EO 13132. 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: gerald.rachanow@fda.hhs.gov Related RIN: Split from 0910-AA01 RIN: 0910-AF37 _______________________________________________________________________ 1024. 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) 06/00/07 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: Local, State Federalism: This action may have federalism implications as defined in EO 13132. 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: gerald.rachanow@fda.hhs.gov Related RIN: Split from 0910-AA01 RIN: 0910-AF39 _______________________________________________________________________ 1025. 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 used to reduce or prevent dental plaque and gingivitis. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM (Plaque Gingivitis) 05/00/07 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: Local, State Federalism: This action may have federalism implications as defined in EO 13132. 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: gerald.rachanow@fda.hhs.gov Related RIN: Split from 0910-AA01 RIN: 0910-AF40 _______________________________________________________________________ 1026. 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 skin bleaching drug products containing hydroquinone. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 08/29/06 71 FR 51146 NPRM Comment Period End 12/27/06 Final Action To Be Determined Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: Local, State Federalism: This action may have federalism implications as defined in EO 13132. 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 [[Page 73219]] Phone: 301 827-2241 Fax: 301 827-2315 Email: gerald.rachanow@fda.hhs.gov RIN: 0910-AF53 _______________________________________________________________________ 1027. 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 321; 21 USC 331; 21 USC 351; 21 USC 352; 21 USC 355; 21 USC 360b; 21 USC 360f; 21 USC 360i; 21 USC 371; 21 USC 374; 21 USC 381; 42 USC 262; 42 USC 264; 42 USC 271 CFR Citation: 21 CFR 211.116; 21 CFR 226.60; 21 CFR 300.200; 21 CFR 500.200; 21 CFR 530; 21 CFR 600.16; 21 CFR 895.102; 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 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 12/00/06 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: 301 827-0591 Fax: 301 827-4774 Email: eric.flamm@fda.hhs.gov Related RIN: Merged with 0910-AF55 RIN: 0910-AF54 _______________________________________________________________________ 1028. 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) 06/00/07 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: Local, State Federalism: This action may have federalism implications as defined in EO 13132. 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: gerald.rachanow@fda.hhs.gov RIN: 0910-AF56 _______________________________________________________________________ 1029. LABEL REQUIREMENT FOR FOOD THAT HAS BEEN REFUSED ADMISSION INTO THE UNITED STATES Regulatory Plan: This entry is Seq. No. 39 in part II of this issue of the Federal Register. RIN: 0910-AF61 _______________________________________________________________________ 1030. 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 ingredients. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 06/00/07 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: Local, State Federalism: This action may have federalism implications as defined in EO 13132. Agency Contact: Walter Ellenberg, Regulatory Project Management Officer, Center for Drug Evaluation and Research, Department of Health and Human Services, Food and Drug [[Page 73220]] Administration, WO22 RM 5489, HFD-569, Rockville, MD 20850 Phone: 301 796-0885 Fax: 301 796-9899 Email: walter.ellenberg@fda.hhs.gov Related RIN: Related to 0910-AC82 RIN: 0910-AF63 _______________________________________________________________________ 1031. 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 target animal safety and effectiveness of a new animal drug proposed for indexing. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 08/22/06 71 FR 48840 NPRM Comment Period Extended 10/02/06 71 FR 57892 NPRM Comment Period End 12/20/06 Final Action 08/00/07 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: andrew.beaulieu@fda.hhs.gov RIN: 0910-AF67 _______________________________________________________________________ 1032. 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) 05/00/07 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: Local, State Federalism: This action may have federalism implications as defined in EO 13132. Agency Contact: Walter Ellenberg, Regulatory Project Management Officer, Center for Drug Evaluation and Research, Department of Health and Human Services, Food and Drug Administration, WO22 RM 5489, HFD- 569, Rockville, MD 20850 Phone: 301 796-0885 Fax: 301 796-9899 Email: walter.ellenberg@fda.hhs.gov RIN: 0910-AF68 _______________________________________________________________________ 1033. 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) 10/00/07 NPRM (Food Handlers) 10/00/07 NPRM (Healthcare Antiseptics) 10/00/07 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: Local, State Federalism: This action may have federalism implications as defined in EO 13132. Agency Contact: Walter Ellenberg, Regulatory Project Management Officer, Center for Drug Evaluation and Research, Department of Health and Human Services, Food and Drug Administration, WO22 RM 5489, HFD- 569, Rockville, MD 20850 Phone: 301 796-0885 Fax: 301 796-9899 Email: walter.ellenberg@fda.hhs.gov RIN: 0910-AF69 _______________________________________________________________________ 1034. 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 331; 21 USC 351 to 353; 21 USC 355; [[Page 73221]] 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 products used for urinary pain relief. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM (Urinary Analgesic) 08/00/07 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: Local, State Federalism: This action may have federalism implications as defined in EO 13132. Agency Contact: Walter Ellenberg, Regulatory Project Management Officer, Center for Drug Evaluation and Research, Department of Health and Human Services, Food and Drug Administration, WO22 RM 5489, HFD- 569, Rockville, MD 20850 Phone: 301 796-0885 Fax: 301 796-9899 Email: walter.ellenberg@fda.hhs.gov RIN: 0910-AF70 _______________________________________________________________________ 1035. IMPORT TOLERANCES FOR ANIMAL DRUGS Priority: Substantive, Nonsignificant Legal Authority: 21 USC 360b(a)(6); 21 USC 371 CFR Citation: Not Yet Determined Legal Deadline: None Abstract: FDA plans to publish a proposed rule related to the implementation of the import tolerances provision of the Animal Drug Availability Act of 1996 (ADAA). The ADAA authorizes FDA to establish drug residue tolerances (import tolerances) for imported food products of animal origin for drugs that are used in other countries, but that are unapproved new animal drugs in the United States. Food products of animal origin that are in compliance with the import tolerances will not be considered adulterated under the Federal Food, Drug, and Cosmetic Act (the Act) and may be imported into the United States. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 03/00/07 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: George Kenneth Haibel, Veterinary Medical Officer, Department of Health and Human Services, Food and Drug Administration, 7519 Standish Place, Rm. 169, MPN-4, HFV-6, Rockville, MD 20855 Phone: 240 276-9019 Fax: 240 276-9101 Email: george.haibel@fda.hhs.gov RIN: 0910-AF78 _______________________________________________________________________ 1036. CURRENT GOOD MANUFACTURING PRACTICE FOR COMBINATION PRODUCTS Priority: Other Significant. Major status under 5 USC 801 is undetermined. Legal Authority: 21 USC 321; 21 USC 331; 21 USC 351; 21 USC 352; 21 USC 353; 21 USC 355; 21 USC 360; 21 USC 360c to 360f; 21 USC 360h to 360j; 21 USC 360l; 21 USC 360hh to 360ss; 21 USC 360aaa to 360bbb; 21 USC 371a; 21 USC 372 to 374; 21 USC 379e; 21 USC 381; 21 USC 394; 42 USC 216; 42 USC 262; 42 USC 263a; 42 USC 264; 42 USC 271 CFR Citation: 21 CFR 4, subchapter A Legal Deadline: None Abstract: The proposed rule would clarify and streamline the current good manufacturing practice (cGMP) requirements for combination products (combinations of a drug, device, and/or biological product). The proposed rule would provide a flexible, quality management regulatory framework that recognizes that, in most instances, for combination products, a properly implemented quality system program under one set of medical product cGMP regulations will meet the requirements of another set (e.g., application of cGMPs for finished pharmaceuticals in 21 CFR 210/211 will generally meet the requirements of the device quality system regulations in 21 CFR 820). It would allow manufacturers the flexibility to select either the cGMP or quality system regulation to apply for the manufacture of their combination product, provided that their system incorporates select, key provisions from the regulations pertaining to the other part of their combination product. It would avoid the necessity to fully implement both sets of cGMP regulations when manufacturing combination products. The proposed rule is intended to ensure consistency and appropriateness in the regulation of combination products. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 03/00/07 Regulatory Flexibility Analysis Required: No Small Entities Affected: Businesses Government Levels Affected: None Agency Contact: James S. Cohen, Senior Counsel, Department of Health and Human Services, Food and Drug Administration, Office of Combination Products, 15800 Crabbs Branch Way, Suite 200 (HFG-3), Rockville, MD 20855 Phone: 301 427-1934 Fax: 301 427-1935 Email: james.cohen@fda.hhs.gov RIN: 0910-AF81 _______________________________________________________________________ 1037. POSTMARKET SAFETY REPORTING FOR COMBINATION PRODUCTS Priority: Other Significant Legal Authority: 21 USC 321; 21 USC 331; 21 USC 351; 21 USC 352; 21 USC 353; 21 USC 355; 21 USC 360; 21 USC 360c to 360f; 21 USC 360h to 360j; 21 USC 360l; 21 USC 360hh to 360ss; 21 USC 360aaa to 360bbb; 21 USC 371a; 21 USC 372 to 374; 21 USC 379e; 21 USC 381; 21 USC 394; 42 USC 216; 42 USC 262; 42 USC 263a; 42 USC 264; 42 USC 271 CFR Citation: 21 CFR 4, subchapter B Legal Deadline: None Abstract: The proposed rule would clarify the postmarket safety reporting requirements for combination products (combinations of a drug, device, and/or biological product). The proposed rule [[Page 73222]] would provide a framework for the reporting of adverse events for combination products. The proposed rule would clarify the circumstances in which following one set of postmarket safety reporting regulations generally would meet the requirements of another set, and the circumstances in which these requirements would be supplemented with specific reporting provisions applicable to the other constituent part of the combination product. The regulation would ensure the consistency and appropriateness of postmarket safety reporting for combination products while avoiding the need for duplicative reporting requirements. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 03/00/07 Regulatory Flexibility Analysis Required: No Small Entities Affected: Businesses Government Levels Affected: None Agency Contact: Leigh Hayes, Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, Office of Combination Products, 15800 Crabbs Branch Way, Suite 200 (HFG-3), Rockville, MD 20855 Phone: 301 427-1934 Fax: 301 427-1935 Email: leigh.hayes@fda.hhs.gov RIN: 0910-AF82 _______________________________________________________________________ 1038. [bull] REVISIONS TO THE REQUIREMENTS APPLICABLE TO BLOOD, BLOOD COMPONENTS, AND SOURCE PLASMA Priority: Routine and Frequent Legal Authority: 21 USC 321; 21 USC 331; 21 USC 351; 21 USC 352; 21 USC 353; 21 USC 355; 21 USC 360; 21 USC 360c; 21 USC 360d; 21 USC 360h; 21 USC 360i; 21 USC 360j; 21 USC 371; 21 USC 372; 21 USC 374; 21 USC 381; 21 USC 393; 42 USC 216; 42 USC 262; 42 USC 263; 42 USC 263a; 42 USC 264; 42 USC 271 CFR Citation: 21 CFR 606.3; 21 CFR 607.65; 21 CFR 640 Legal Deadline: None Abstract: FDA is issuing this rulemaking to amend the biologics regulations by removing, revising, or updating specific regulations applicable to blood, blood components, and Source Plasma to be more consistent with current practices in the blood industry and to remove unnecessary or outdated requirements. Some examples of the amendments include revisions to the dating period for Platelets, Red Blood Cells Deglycerolized, and Red Blood Cells Frozen; storage temperatures for blood; and pooling and pH level of Platelets. FDA is also removing two obsolete regulations. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM - Companion to Direct Final Rule 03/00/07 Direct Final Rule 03/00/07 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Stephen M. Ripley, Team Leader, Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research, Suite 200N, HFM-17, 1401 Rockville Pike, Rockville, MD 20852-1448 Phone: 301 827-6210 Fax: 301 827-9434 RIN: 0910-AF84 _______________________________________________________________________ 1039. [bull] REVISION OF THE REQUIREMENTS FOR LIVE VACCINE PROCESSING Priority: Other Significant Legal Authority: 21 USC 321; 21 USC 351 to 353; 21 USC 355; 21 USC 360; 21 USC 360i; 21 USC 371; 21 USC 374; 42 USC 216; 42 USC 262; 42 USC 263; 42 USC 263a; 42 USC 264; 42 USC 300aa-25 CFR Citation: 21 CFR 600.11 Legal Deadline: None Abstract: This rulemaking is being issued to provide options to the existing requirement for processing live vaccines. FDA is amending the regulations due to advances in facility, system, and equipment design, and in sterilization technologies that will allow live vaccine processing to be performed in multiproduct manufacturing areas. We are amending this regulation to permit manufacturers greater flexibility in the use of their buildings and equipment for processing live vaccines when appropriate controls exist and have been demonstrated to be effective in preventing cross contamination of other products and areas. We are taking this action as part of our continuing effort to reduce the burden of unnecessary regulations and to revise outdated regulations without diminishing public health protection. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM--Companion to Direct Final Rule 05/00/07 Direct Final Rule 05/00/07 Regulatory Flexibility Analysis Required: No Government Levels Affected: None Agency Contact: Nathaniel L. Geary, Consumer Safety Officer, Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaulation and Research, 1401 Rockville Pike, HFM-17, Rockville, MD 20852-1448 Phone: 301 827-6210 Fax: 301 827-9434 Email: nathaniel.geary@fda.hhs.gov RIN: 0910-AF85 _______________________________________________________________________ 1040. [bull] MEDICAL DEVICE REPORTING; ELECTRONIC SUBMISSION REQUIREMENTS Regulatory Plan: This entry is Seq. No. 40 in part II of this issue of the Federal Register. RIN: 0910-AF86 _______________________________________________________________________ 1041. [bull] LASER PRODUCTS; AMENDMENT TO PERFORMANCE STANDARD Priority: Substantive, Nonsignificant Legal Authority: 21 USC 360kk CFR Citation: 21 CFR 1020; 21 CFR 1040 Legal Deadline: None Abstract: FDA is proposing to amend the performance standard for laser products to achieve harmonization between the current standard International Electrotechnical Commission (IEC) standard for laser products and medical laser products. The proposed amendment is intended to update FDA's performance standard to reflect advancements in technology. The proposal would adopt portions of an IEC standard (to achieve harmonization and reflect current science), include an alternative mechanism for providing certification and identification, address novelty laser [[Page 73223]] products, and clarify the military exemption for laser products. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 06/00/07 Regulatory Flexibility Analysis Required: Undetermined Small Entities Affected: Businesses Government Levels Affected: None Agency Contact: Myrna Hanna, Regulations Staff, Department of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health, HFZ-215, 1350 Piccard Drive, PI50 RM150F, Rockville, MD 20850 Phone: 240 276-2347 Fax: 240 276-2352 Email: myrna.hanna@fda.hhs.gov RIN: 0910-AF87 _______________________________________________________________________ 1042. [bull] ELECTRONIC REGISTRATION AND LISTING FOR DEVICES Regulatory Plan: This entry is Seq. No. 41 in part II of this issue of the Federal Register. RIN: 0910-AF88 _______________________________________________________________________ 1043. [bull] REGULATIONS ON FIXED-COMBINATION DRUG PRODUCTS Priority: Substantive, Nonsignificant Legal Authority: 21 USC 331; 21 USC 351; 21 USC 352; 21 USC 355; 21 USC 371 CFR Citation: 21 CFR 300.50 Legal Deadline: None Abstract: The proposed rule would amend FDA regulations on fixed- combination prescription and OTC drugs. The current regulations require, among other things, that the sponsor of a fixed-combination drug demonstrate that each of the components makes a contribution to the drug's claimed effects. The proposed rule would create a single set of regulations for prescription and OTC combination drugs and codify existing policy on what kinds of studies are needed to show that the combination drug requirements are met, and it would clarify application of FDA's combination policy to certain natural source drugs and certain synthetic drugs. The regulation would also establish circumstances under which the agency might waive the combination drug requirements for a particular drug. The proposed rule will also address the issue of co-packaging. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 09/00/07 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: brian.pendleton@fda.hhs.gov RIN: 0910-AF89 _______________________________________________________________________ 1044. [bull] USE OF OZONE-DEPLETING SUBSTANCES; REMOVAL OF ESSENTIAL USE DESIGNATIONS [EPINEPHRINE] Priority: Other Significant. Major status under 5 USC 801 is undetermined. Legal Authority: 21 USC 321; 21 USC 331; 21 USC 335; 21 USC 342; 21 USC 346a; 21 USC 348; 21 USC 355; 42 USC 7671 et seq CFR Citation: 21 CFR 1.25 (revision); 40 CFR 82.4; 40 CFR 82.64; 40 CFR 82.66 Legal Deadline: None Abstract: Medical products using chlorofluorocarbons (CFCs) and other ozone-depleting substances may only be legally marketed if they are listed in 21 CFR 2.125 as ``essential uses.'' This proposed rule would remove the essential use designations after a specified date for metered-dose inhalers (MDIs) containing epinephrine. Under the provisions of this proposed rule these MDIs would have to be removed from the market. This proposed rule is consistent with obligations under the Clean Air Act and the Montreal Protocol on Substances that Deplete the Ozone Layer. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 07/00/07 Regulatory Flexibility Analysis Required: No Government Levels Affected: None Agency Contact: Wayne H. Mitchell, Regulatory Counsel, Office of Regulatory Policy, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, 5600 Fishers Lane, HFD-7, Rockville, MD 20857 Phone: 301 594-2041 Fax: 301 827-0951 Email: wayne.mitchell@fda.hhs.gov RIN: 0910-AF92 _______________________________________________________________________ 1045. [bull] USE OF OZONE-DEPLETING SUBSTANCES; REMOVAL OF ESSENTIAL USE DESIGNATIONS [FLUNISOLIDE, TRIAMCINOLONE, METAPROTERENOL, PIRBUTEROL, ALBUTEROL AND IPRATROPIUM IN COMBINATION, CROMOLYN, AND NEDOCROMIL]. Priority: Other Significant. Major under 5 USC 801. Legal Authority: 21 USC 321; 21 USC 331; 21 USC 335; 21 USC 342; 21 USC 346a; 21 USC 348; 21 USC 355; 42 USC 7671 et seq CFR Citation: 21 CFR 1.25 (revision); 40 CFR 82.4; 40 CFR 82.64; 40 CFR 82.66 Legal Deadline: None Abstract: Medical products using chlorofluorocarbons (CFCs) and other ozone-depleting substances may only be legally marketed if they are listed in 21 CFR 2.125 as ``essential uses.'' This proposed rule would remove the essential use designations after a specified date for metered-dose inhalers (MDIs) containing flunisolide, triamcinolone, metaproterenol, pirbuterol, albuterol and ipratropium in combination, cromolyn, and nedocromil. Under the provisions of this proposed rule these MDIs would have to be removed from the market. This proposed rule is consistent with obligations under the Clean Air Act and the Montreal Protocol on Substances that Deplete the Ozone Layer. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 05/00/07 Regulatory Flexibility Analysis Required: No Government Levels Affected: None Agency Contact: Wayne H. Mitchell, Regulatory Counsel, Office of Regulatory Policy, Department of [[Page 73224]] Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, 5600 Fishers Lane, HFD-7, Rockville, MD 20857 Phone: 301 594-2041 Fax: 301 827-0951 Email: wayne.mitchell@fda.hhs.gov RIN: 0910-AF93 _______________________________________________________________________ Department of Health and Human Services (HHS) Final Rule Stage Food and Drug Administration (FDA) _______________________________________________________________________ 1046. FOREIGN AND DOMESTIC ESTABLISHMENT REGISTRATION AND LISTING REQUIREMENTS FOR HUMAN DRUGS, INCLUDING DRUGS THAT ARE REGULATED UNDER A BIOLOGICS LICENSE APPLICATION, AND ANIMAL DRUGS Priority: Other Significant Legal Authority: 21 USC 321; 21 USC 331; 21 USC 351; 21 USC 352; 21 USC 355; 21 USC 360; 21 USC 360b; 21 USC 371; 21 USC 374; 42 USC 262; 42 USC 264; 42 USC 271 CFR Citation: 21 CFR 20; 21 CFR 201; 21 CFR 207; 21 CFR 314; 21 CFR 330; 21 CFR 514; 21 CFR 515; 21 CFR 601; 21 CFR 607; 21 CFR 610; 21 CFR 1271 Legal Deadline: None Abstract: The rule will reorganize, consolidate, clarify, and modify current regulations at 21 CFR part 207 concerning who must register establishments and list human drugs, certain biological drugs, and animal drugs. These regulations contain information on when, how, and where to register drug establishments and list drugs, and what information must be submitted for initial registration and listing and for changes to registration and listing. The rule will require that this information be submitted via the Internet into the FDA registration and listing database, instead of the current requirement to submit the information to FDA on paper forms. The rule will also require that the NDC number appear on certain drug labels. In addition, FDA will assign the NDC number to newly listed drugs and take other steps to minimize the use of inaccurate NDC numbers on drug labels. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 08/29/06 71 FR 51276 NPRM Comment Period End 11/27/06 Final Action 09/00/07 Regulatory Flexibility Analysis Required: Undetermined Small Entities Affected: Businesses Government Levels Affected: None Agency Contact: Howard P. Muller, Office of Regulatory Policy, Department of Health and Human Services, Food and Drug Administration, 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: howard.mullerjr@fda.hhs.gov RIN: 0910-AA49 _______________________________________________________________________ 1047. SAFETY REPORTING REQUIREMENTS FOR HUMAN DRUG AND BIOLOGICAL PRODUCTS Priority: Other Significant. Major status under 5 USC 801 is undetermined. Unfunded Mandates: Undetermined Legal Authority: 42 USC 216; 42 USC 241; 42 USC 242a; 42 USC 262; 42 USC 263; 42 USC 263a to 263-n; 42 USC 264; 42 USC 300aa; 21 USC 321; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 360; 21 USC 360b to 360j; 21 USC 361a; 21 USC 371; 21 USC 374; 21 USC 375; 21 USC 379e; 21 USC 381 CFR Citation: 21 CFR 310; 21 CFR 312; 21 CFR 314; 21 CFR 320; 21 CFR 600; 21 CFR 601; 21 CFR 606 Legal Deadline: None Abstract: This regulation is one component of the Secretary's initiative to reduce medical errors. The final rule would amend the expedited and periodic safety reporting regulations for human drugs and biological products to revise certain definitions and reporting formats as recommended by the International Conference on Harmonisation and to define new terms; to add to or revise current reporting requirements; to revise certain reporting time frames; and propose other revisions to these regulations to enhance the quality of safety reports received by FDA. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 03/14/03 68 FR 12406 NPRM Comment Period Extended 06/18/03 NPRM Comment Period End 07/14/03 NPRM Comment Period Extension End 10/14/03 Comment Review End 04/00/07 Final Action 09/00/07 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 _______________________________________________________________________ 1048. 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 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 rule would also amend the regulations on extension of the review clock because of amendments to applications. [[Page 73225]] Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 07/20/04 69 FR 43357 Final Action 04/00/07 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: brian.pendleton@fda.hhs.gov RIN: 0910-AB34 _______________________________________________________________________ 1049. 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 263 to 42 USC 263a; 42 USC 264; 21 USC 372; 21 USC 381 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 02/00/07 Regulatory Flexibility Analysis Required: No Small Entities Affected: Businesses Government Levels Affected: None Agency Contact: Stephen M. Ripley, Team Leader, Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research, Suite 200N, HFM-17, 1401 Rockville Pike, Rockville, MD 20852-1448 Phone: 301 827-6210 Fax: 301 827-9434 Related RIN: Related to 0910-AB26 RIN: 0910-AB76 _______________________________________________________________________ 1050. CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKING, OR HOLDING DIETARY INGREDIENTS AND DIETARY SUPPLEMENTS Regulatory Plan: This entry is Seq. No. 42 in part II of this issue of the Federal Register. RIN: 0910-AB88 _______________________________________________________________________ 1051. ADDITIONAL SAFEGUARDS FOR CHILDREN IN CLINICAL INVESTIGATIONS 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 04/00/07 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 _______________________________________________________________________ 1052. 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 [[Page 73226]] 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 06/00/07 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: John Sheehan, Director, Department of Health and Human Services, Food and Drug Administration, Division o Dairy and Egg Safety (HFS-032), 5100 Paint Branch Parkway, College Park, MD 20740 Phone: 301 436-1488 Fax: 301 436-2632 Email: john.sheehan@fda.hhs.gov RIN: 0910-AC14 _______________________________________________________________________ 1053. INSTITUTIONAL REVIEW BOARDS: REGISTRATION REQUIREMENTS Priority: Info./Admin./Other Legal Authority: 21 USC 321; 21 USC 346 to 21 USC 346a; 21 USC 348; 21 USC 351 to 353; 21 USC 355; 21 USC 360; 21 USC 360c to 360f; 21 USC 360h to 360j; 21 USC 371; 21 USC 379e; 21 USC 381; 42 USC 216; 42 USC 241; 42 USC 262; 42 USC 263b to 263n CFR Citation: 21 CFR 56.106 Legal Deadline: None Abstract: The final rule would require institutional review boards (IRB) to register with the Department of Health and Human Services. 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 number of active protocols 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 04/00/07 Regulatory Flexibility Analysis Required: No Government Levels Affected: None Agency Contact: Philip L. Chao, Senior Policy Analyst, Department of Health and Human Services, Food and Drug Administration, Office of Policy and Planning (HF-23), 5600 Fishers Lane, Room 14C-17, Rockville, MD 20857 Phone: 301 827-0587 Fax: 301 827-4774 Email: philip.chao@fda.hhs.gov RIN: 0910-AC17 _______________________________________________________________________ 1054. 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 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 06/07/06 71 FR 32827 Final Action 04/00/07 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: State Federalism: This action may have federalism implications as defined in EO 13132. Agency Contact: Catherine Lorraine, Director, Policy Development and [[Page 73227]] Coordination Group, Office of Policy and Planning, Department of Health and Human Services, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857 Phone: 301 827-3360 Fax: 301 594-6777 RIN: 0910-AC25 _______________________________________________________________________ 1055. MEDICAL DEVICES; PATIENT EXAMINATION AND SURGEONS' GLOVES; TEST PROCEDURES AND ACCEPTANCE CRITERIA Priority: Routine and Frequent 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 will 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 12/00/06 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, PI50 RM150F, Rockville, MD 20850 Phone: 240 276-2347 Fax: 240 276-2352 Email: myrna.hanna@fda.hhs.gov RIN: 0910-AC32 _______________________________________________________________________ 1056. TOLL-FREE NUMBER FOR REPORTING ADVERSE EVENTS ON LABELING FOR HUMAN DRUGS Priority: Other Significant Legal Authority: 21 USC 355b CFR Citation: 21 CFR 201; 21 CFR 208; 21 CFR 209 Legal Deadline: Final, Statutory, January 4, 2003. Abstract: To require the labeling of human drugs approved under section 505 of the Federal Food, Drug, and Cosmetic Act to include a toll-free number for reports of adverse events, and a statement that the number is to be used for reporting purposes only and not to receive medical advice. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 04/22/04 69 FR 21778 NPRM Comment Period End 07/21/04 Final Action 09/00/07 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: None Agency Contact: Carol Drew, Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, 5515 Security Lane, Suite 1101 (HFD-7), Rockville, MD 20852 Phone: 301 594-2041 Fax: 301 827-5562 RIN: 0910-AC35 _______________________________________________________________________ 1057. PRIOR NOTICE OF IMPORTED FOOD UNDER THE PUBLIC HEALTH SECURITY AND BIOTERRORISM PREPAREDNESS AND RESPONSE ACT OF 2002 Regulatory Plan: This entry is Seq. No. 43 in part II of this issue of the Federal Register. RIN: 0910-AC41 _______________________________________________________________________ 1058. MEDICAL GAS CONTAINERS AND CLOSURES; CURRENT GOOD MANUFACTURING PRACTICE REQUIREMENTS Priority: Other Significant Legal Authority: 21 USC 321; 21 USC 351 to 21 USC 353 CFR Citation: 21 CFR 201.161(a); 21 CFR 211.94; 21 CFR 211.125 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 04/10/06 71 FR 18039 NPRM Comment Period End 07/10/06 Final Action 04/00/07 Regulatory Flexibility Analysis Required: Undetermined Government Levels Affected: None Agency Contact: Quynh H. Nguyen, Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, Office of Regulatory Policy, 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: quynh.h.nguyen@fda.hhs.gov RIN: 0910-AC53 [[Page 73228]] _______________________________________________________________________ 1059. 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 05/00/07 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: 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: brian.pendleton@fda.hhs.gov Related RIN: Previously reported as 0910-AB63 RIN: 0910-AC55 _______________________________________________________________________ 1060. 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 02/00/07 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: brian.pendleton@fda.hhs.gov RIN: 0910-AF15 _______________________________________________________________________ 1061. 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 amending 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), would not allow registered blood establishments or hemophilia treatment centers that provide health care services to concurrently distribute drugs, including 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 intends to delay the effective date of those provisions while FDA is considering comments on the proposed rule. FDA is amending the final rule to allow registered blood establishments and certain hemophilia treatment centers that concurrently provide health care services related to their activities as blood establishments or hemophilia treatment centers to also distribute certain products, including blood derivatives. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 02/01/06 71 FR 5200 NPRM Comment Period End 05/02/06 Final Action 10/00/07 Regulatory Flexibility Analysis Required: No Government Levels Affected: None Additional Information: Delayed effective date of portion of rule to 12/01/06, effective date of non-stayed portion of final rule, 64 FR 67720, December 3, 1999 Agency Contact: Kathleen E. Swisher, Supervisory Regulatory Counsel, Department of Health and Human Services, Food and Drug [[Page 73229]] 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 _______________________________________________________________________ 1062. OBSTETRICAL AND GYNECOLOGICAL DEVICES; DESIGNATION OF SPECIAL CONTROL FOR CONDOMS AND CONDOMS WITH SPERMICIDAL LUBRICANT Priority: Other Significant 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 11/14/05 70 FR 69102 Final Action 07/00/07 Regulatory Flexibility Analysis Required: No Small Entities Affected: Businesses Government Levels Affected: None Agency Contact: Myrna Hanna, Regulations Staff, Department of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health, HFZ-215, 1350 Piccard Drive, PI50 RM150F, Rockville, MD 20850 Phone: 240 276-2347 Fax: 240 276-2352 Email: myrna.hanna@fda.hhs.gov RIN: 0910-AF21 _______________________________________________________________________ 1063. BLOOD INITIATIVE--REVISIONS TO LABELING REQUIREMENTS FOR BLOOD AND BLOOD COMPONENTS, INCLUDING SOURCE PLASMA; AND TECHNICAL AMENDMENT Priority: Other Significant Legal Authority: 21 USC 310; 21 USC 321; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 360; 21 USC 360d; 21 USC 360h to 360j; 21 USC 371; 21 USC 374; 21 USC 381; 42 USC 216; 42 USC 262; 42 USC 263; 42 USC 263a; 42 USC 264; 42 USC 300aa to 25 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 human blood and 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 10/00/07 Regulatory Flexibility Analysis Required: No 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 _______________________________________________________________________ 1064. 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 NPRM Comment Period Reopened 04/28/03 68 FR 22341 NPRM Comment Period Extended 06/27/03 68 FR 38247 NPRM Comment Period End 08/26/03 NPRM Comment Period Reopened 08/01/06 71 FR 43392 NPRM Comment Period End 09/15/06 Final Action 09/00/07 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Benson Silverman, Department of Health and Human [[Page 73230]] Services, Food and Drug Administration, Center for Food Safety and Applied Nutrition, 5100 Paint Branch Parkway, HFS-024, College Park, MD 20740 Phone: 301 436-1459 Email: benson.silverman@fda.hhs.gov Related RIN: Split from 0910-AA04 RIN: 0910-AF27 _______________________________________________________________________ 1065. 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. The comment period was reopened on August 1, 2006 to end on September 15, 2006. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 07/09/96 61 FR 36154 NPRM Comment Period End 12/06/96 NPRM Comment Period Reopened 04/28/03 68 FR 22341 NPRM Comment Period Extended 06/27/03 68 FR 38247 NPRM Comment Period End 08/26/03 Final Action 09/00/07 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Benson Silverman, Department of Health and Human Services, Food and Drug Administration, Center for Food Safety and Applied Nutrition, 5100 Paint Branch Parkway, HFS-024, College Park, MD 20740 Phone: 301 436-1459 Email: benson.silverman@fda.hhs.gov Related RIN: Split from 0910-AA04 RIN: 0910-AF28 _______________________________________________________________________ 1066. 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) 06/00/07 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: Local, State Federalism: This action may have federalism implications as defined in EO 13132. 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: gerald.rachanow@fda.hhs.gov Related RIN: Split from 0910-AA01 RIN: 0910-AF31 _______________________________________________________________________ 1067. 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 06/00/07 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: Local, State Federalism: This action may have federalism implications as defined in EO 13132. 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: gerald.rachanow@fda.hhs.gov Related RIN: Split from 0910-AA01 RIN: 0910-AF32 _______________________________________________________________________ 1068. 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 [[Page 73231]] 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 06/00/07 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: Local, State Federalism: This action may have federalism implications as defined in EO 13132. 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: gerald.rachanow@fda.hhs.gov Related RIN: Split from 0910-AA01 RIN: 0910-AF33 _______________________________________________________________________ 1069. 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 phenyl propanolamine. 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 (Phenylpro panolamine) 12/22/05 70 FR 75988 Final Action (Amendment) (Sinusitis Claim) 10/31/05 70 FR 58974 Final Action (Phenylephrine Bitartrate) 08/01/06 71 FR 83358 Final Action (Phenyl propanolamine) 05/00/07 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: Local, State Federalism: This action may have federalism implications as defined in EO 13132. 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: gerald.rachanow@fda.hhs.gov Related RIN: Split from 0910-AA01 RIN: 0910-AF34 _______________________________________________________________________ 1070. 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: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Final Action 09/00/07 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: Local, State Federalism: This action may have federalism implications as defined in EO 13132. 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: gerald.rachanow@fda.hhs.gov Related RIN: Split from 0910-AA01 RIN: 0910-AF35 _______________________________________________________________________ 1071. 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. One action will address laxative drug products. The other action will address psyllium laxative drug products in a granular dosage form. [[Page 73232]] Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Final Action (Granular Psyllium)05/00/07 Final Action (Laxative Drug Products) 06/00/07 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: Local, State Federalism: This action may have federalism implications as defined in EO 13132. 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: gerald.rachanow@fda.hhs.gov Related RIN: Split from 0910-AA01 RIN: 0910-AF38 _______________________________________________________________________ 1072. 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) 03/00/07 Final Action (Fever Blisters/ Cold Sores) 06/00/07 Final Action (Diaper Rash) 06/00/07 NPRM (Amendment) (Diaper Rash Drug Product) 06/00/07 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: Local, State Federalism: This action may have federalism implications as defined in EO 13132. 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: gerald.rachanow@fda.hhs.gov Related RIN: Split from 0910-AA01 RIN: 0910-AF42 _______________________________________________________________________ 1073. OVER-THE-COUNTER (OTC) DRUG REVIEW--VAGINAL CONTRACEPTIVE PRODUCTS Priority: Routine and Frequent Legal Authority: 21 USC 321p; 21 USC 351 to 353; 21 USC 355; 21 USC 360a; 21 USC 371a; 21 USC 331; 21 USC 358; 21 USC 360; 21 USC 360gg to 360ss; 21 USC 371; 21 USC 374; 21 USC 379e; 42 USC 216; 42 USC 241; 42 USC 262; 42 USC 264 CFR Citation: 21 CFR 201; 21 CFR 310; 21 CFR 330 to 358 Legal Deadline: None Abstract: The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safe and effective and not misbranded. After a final monograph (i.e., final rule) is issued, only OTC drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. One action will address labeling warning statements for products containing Nonoxynol 9. The other action addresses vaginal contraceptive drug products. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Final Action (Warnings) 12/00/06 NPRM (Vaginal Contraceptive Drug Products) 06/00/07 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: Local, State Federalism: This action may have federalism implications as defined in EO 13132. 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: gerald.rachanow@fda.hhs.gov Related RIN: Split from 0910-AA01 RIN: 0910-AF44 _______________________________________________________________________ 1074. 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 phenyl propanolamine, and the other action addresses the ingredient benzocaine. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM (Phenyl propanolamine) 12/22/05 70 FR 75988 NPRM (Benzocaine) 06/00/07 [[Page 73233]] Final Action (Phenyl propanolamine) 05/00/07 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: Local, State Federalism: This action may have federalism implications as defined in EO 13132. 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: gerald.rachanow@fda.hhs.gov Related RIN: Split from 0910-AA01 RIN: 0910-AF45 _______________________________________________________________________ 1075. OVER-THE-COUNTER (OTC) DRUG REVIEW--DANDRUFF, SEBORRHEIC DERMATITIS, AND PSORIASIS PRODUCTS Priority: Routine and Frequent Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 360; 21 USC 360a; 21 USC 371; 21 USC 371a CFR Citation: 21 CFR 201; 21 CFR 310; 21 CFR 330 to 358 Legal Deadline: None Abstract: The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safe and effective and not misbranded. After a final monograph (i.e., final rule) is issued, only OTC drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. This action addresses combinations containing coal tar solution and menthol in a shampoo product. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM (Amendment) 12/09/05 70 FR 73178 Final Action 06/00/07 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: Local, State Federalism: This action may have federalism implications as defined in EO 13132. 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: gerald.rachanow@fda.hhs.gov RIN: 0910-AF49 _______________________________________________________________________ 1076. 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 06/00/07 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: Local, State Federalism: This action may have federalism implications as defined in EO 13132. 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: gerald.rachanow@fda.hhs.gov RIN: 0910-AF51 _______________________________________________________________________ 1077. OVER-THE-COUNTER (OTC) DRUG REVIEW--ANTACID PRODUCTS Priority: Routine and Frequent Legal Authority: 21 USC 321p; 21 USC 351 to 353; 21 USC 355; 21 USC 360; 21 USC 360a; 21 USC 371; 21 USC 371a; 21 USC 331 CFR Citation: 21 CFR 201; 21 CFR 310; 21 CFR 330 to 358 Legal Deadline: None Abstract: The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safe and effective and not misbranded. After a final monograph (i.e., final rule) is issued, only OTC drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. One action addresses the labeling of products containing sodium bicarbonate as an active ingredient. The other action addresses the use of antacids to relieve upset stomach associated with overindulgence in food and drink. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Final Action (Overindulgence Labeling) 06/00/07 Final Action (Sodium Bicarbonate Labeling) 06/00/07 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: Local, State Federalism: This action may have federalism implications as defined in EO 13132. 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 [[Page 73234]] Evaluation and Research, 5600 Fishers Lane, HFD-560, Rockville, MD 20857 Phone: 301 827-2241 Fax: 301 827-2315 Email: gerald.rachanow@fda.hhs.gov RIN: 0910-AF52 _______________________________________________________________________ 1078. SUPPLEMENTS AND OTHER CHANGES TO APPROVED NEW ANIMAL DRUG APPLICATIONS Priority: Substantive, Nonsignificant Legal Authority: 21 USC 351; 21 USC 352; 21 USC 356a; 21 USC 360b; 21 USC 371 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 12/00/06 Final Action Effective 02/00/07 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: dennis.bensley@fda.hhs.gov RIN: 0910-AF59 _______________________________________________________________________ 1079. DESIGNATION OF NEW ANIMAL DRUGS FOR MINOR USES OR MINOR SPECIES Priority: Other Significant Legal Authority: 21 USC 360ccc-2 CFR Citation: 21 CFR 516 Legal Deadline: NPRM, Statutory, August 2, 2005. Final, Statutory, August 2, 2006. Abstract: The proposed rule was published on September 27, 2005, in response to the Minor Use and Minor Species (MUMS) Animal Health Act of 2004. The proposed rule would implement section 573 of the MUMS Act which sets forth the requirements for drug sponsors requesting MUMS designation for proposed new animal drugs. MUMS designation of a new animal drug allows 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 would define content and format requirements for designation, requests changing designation ownership, and annual reporting requirements. This rule would also describe the criteria CVM will use for granting or denying these requests. Specific sections of the rule are dedicated to documentation of MUMS status in a request, granting MUMS designation, and revocation of MUMS designation. FDA intends to finalize this proposal after reviewing any comments received. This is a voluntary program for animal drug sponsors. A large number of these drug companies are classified as small businesses. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 09/27/05 70 FR 56394 NPRM Comment Period End 12/12/05 Final Rule 01/00/07 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: andrew.beaulieu@fda.hhs.gov RIN: 0910-AF60 _______________________________________________________________________ 1080. 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) issued 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 took 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 blood vessels (FDA jurisdiction) and organs (HRSA jurisdiction). We received significant adverse comments in response to the direct final rule. Therefore, the direct final rule is being withdrawn. FDA and HRSA intend to finalize the proposed rule after considering comments. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM - Companion to Direct Final Rule 05/12/06 71 FR 27649 Direct Final Rule 05/12/06 71 FR 27606 Comment Period End 07/26/06 Direct Final Rule-Withdrawal 09/14/06 71 FR 54198 Final Action 09/00/07 [[Page 73235]] Regulatory Flexibility Analysis Required: No Government Levels Affected: None Agency Contact: Denise Sanchez, Regulatory Policy Analyst, Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research, HFM-17, 1401 Rockville Pike, Rockville, MD 20852-1448 Phone: 301 827-6210 Fax: 301 827-9434 RIN: 0910-AF65 _______________________________________________________________________ 1081. [bull] EXCEPTIONS OR ALTERNATIVES TO LABELING REQUIREMENTS FOR PRODUCTS HELD BY THE STRATEGIC NATIONAL STOCKPILE Priority: Other Significant Legal Authority: 15 USC 1451 to 1561; 21 USC 321; 21 USC 331; 21 USC 351 to 353; 21 USC 355 and 356; 21 USC 358; 21 USC 360; 21 USC 371 to 375; 21 USC 379; 21 USC 381 and 382; 21 USC 393; 42 USC 216; 42 USC 241; 42 USC 262 to 264; 42 USC 271 CFR Citation: 21 CFR 201; 21 CFR 312; 21 CFR 314; 21 CFR 601; 21 CFR 610; 21 CFR 801; 21 CFR 807; 21 CFR 809; 21 CFR 812; 21 CFR 814 Legal Deadline: None Abstract: FDA is issuing regulations to permit FDA Center Directors to grant an exception or alternative to certain regulatory labeling provisions applicable to human drugs, biological products, or medical devices that are or will be included in the Strategic National Stockpile (SNS). Under this rule, the appropriate Center Director may grant an exception or alternative to such labeling requirements if he or she determines that compliance with such requirements could adversely affect the safety, effectiveness, or availability of specified lots, batches, or other units of human drugs, biological products, or medical devices that are or will be included in the SNS. A grant of an exception or alternative under these regulations will include any safeguards or conditions deemed appropriate by the Center Director to ensure that the labeling of such products includes information for the safe and effective use of the products given their anticipated circumstances of use. This rule will facilitate the safety, effectiveness, and availability of appropriate medical countermeasures in the event of a public health emergency. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Interim Final Rule 05/00/07 Regulatory Flexibility Analysis Required: No Government Levels Affected: None Agency Contact: Astrid L. Szeto, Director Regulatory Review Officer, Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research (HFM-17), 1401 Rockville Pike, Suite 200N, Rockville, MD 20852-1448 Phone: 301 827-6210 Fax: 301 827-9434 Email: astrid.szeto@fda.hhs.gov RIN: 0910-AF90 _______________________________________________________________________ Department of Health and Human Services (HHS) Long-Term Actions Food and Drug Administration (FDA) _______________________________________________________________________ 1082. 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, FDA is proposing to require that food or cosmetic products derived from animals exposed to CWD not enter into commerce. Timetable: Next Action Undetermined 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, 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@fda.hhs.gov RIN: 0910-AC21 [[Page 73236]] _______________________________________________________________________ 1083. 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, 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 _______________________________________________________________________ 1084. 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.hhs.gov Related RIN: Related to 0910-AB66 RIN: 0910-AC50 _______________________________________________________________________ 1085. FOOD STANDARDS: GENERAL PRINCIPLES AND FOOD STANDARDS MODERNIZATION Priority: Other Significant Legal Authority: 21 USC 321; 21 USC 336; 21 USC 341; 21 USC 343; 21 USC 371 CFR Citation: 21 CFR 130.5 Legal Deadline: None Abstract: In 1995, the FDA and FSIS reviewed their regulatory procedures and requirements for food standards to determine whether any were still needed, and if so, which ones should be modified or streamlined. To request public comment to assist them in their review of the need for food standards, both Agencies published advance notices of proposed rulemaking (ANPRMs) on food standards in December 1995 (60 FR 47453 and 60 FR 67492). These ANPRMs discussed the Agencies' regulations and policy governing food standards, the history of food standards, and the possible need to revise the food standards. Several comments in response to the ANPRMs recommended that the Agencies establish general principles or a fundamental philosophy for reviewing food standards and revising them. The Agencies agreed with these comments and determined that it would be appropriate to develop general principles for reviewing and revising food standards regulations. The Agencies also agreed with the comments that stated that the Agencies should work in concert to develop [[Page 73237]] 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, 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@fda.hhs.gov Related RIN: Related to 0583-AC72 RIN: 0910-AC54 _______________________________________________________________________ 1086. 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: howard.mullerjr@fda.hhs.gov RIN: 0910-AF08 _______________________________________________________________________ 1087. 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: 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.hhs.gov RIN: 0910-AF09 _______________________________________________________________________ 1088. COCHINEAL EXTRACT AND CARMINE LABEL DECLARATION Priority: Other Significant Legal Authority: 21 USC 379e(b) CFR Citation: 21 CFR 73.100(d); 21 CFR 73.2087(c); 21 CFR 101.22(k) Legal Deadline: None Abstract: The Agency published a proposed rule on January 30, 2006, to require the label declaration of all foods and cosmetics containing the color additives cochineal extract and carmine in order to protect consumers with allergies to these additives. This proposal was issued in response to adverse event reports received by FDA and to a citizen petition submitted to FDA. The comment period ended on May 1, 2006. FDA intends to issue a final rule after reviewing comments. [[Page 73238]] Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 01/30/06 71 FR 4839 NPRM Comment Period End 05/01/06 Final Action To Be Determined 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: mical.honigfort@fda.hhs.gov RIN: 0910-AF12 _______________________________________________________________________ 1089. 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 Federalism: 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: jill.kevala@fda.hhs.gov RIN: 0910-AF22 _______________________________________________________________________ 1090. 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 Federalism: Undetermined Agency Contact: Mary Brandt, Supervisor Team Leader, Department of Health and Human Services, Food and Drug Administration, HFS-840, 5100 Paint Branch Parkway, College Park, MD 20740 Phone: 301 436-1788 Fax: 301-436-2635 Email: mary.brandt@fda.hhs.gov RIN: 0910-AF23 _______________________________________________________________________ 1091. 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 348; 21 USC 371 CFR Citation: 21 CFR 589.2001 Legal Deadline: None Abstract: On October 6, 2005, the Food and Drug Administration (FDA) proposed 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 To Be Determined 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 _______________________________________________________________________ 1092. 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 (IFR), effective [[Page 73239]] 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 under the IFR 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. On September 7, 2005, FDA amended the IFR to permit the use of small intestine in human food and cosmetics if it is effectively removed from the distal ileum. The amendment also clarified that milk and milk products, hides, and tallow derivatives are not prohibited for use in human food and cosmetics. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Interim Final Rule 07/14/04 69 FR 42256 Interim Final Rule Comment Period End 10/12/04 Interim Final Rule (Ammendments)09/07/05 70 FR 53063 Final Action To Be Determined Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Morris E. Potter, Lead Scientist for Epidemiology, Department of Health and Human Services, Food and Drug Administration, Center for Food Safety and Applied Nutrition, HFS-032, 60 Eighth St., NE., Atlanta, GA 30309 Phone: 404 253-1225 Fax: 404-253-1218 Email: morris.potter@fda.hhs.gov RIN: 0910-AF47 _______________________________________________________________________ Department of Health and Human Services (HHS) Completed Actions Food and Drug Administration (FDA) _______________________________________________________________________ 1093. REVOCATION OF THE STATUS OF SPECIFIC PRODUCTS; GROUP A STREPTOCOCCUS Priority: Info./Admin./Other CFR Citation: 21 CFR 610.19 Completed: ________________________________________________________________________ Reason Date FR Cite ________________________________________________________________________ Final Action 04/21/06 71 FR 20533 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Valerie Butler Phone: 301 827-6210 Fax: 301 827-9434 RIN: 0910-AF20 _______________________________________________________________________ 1094. RECORDKEEPING REQUIREMENTS FOR HUMAN FOOD AND COSMETICS MANUFACTURED FROM, PROCESSED WITH, OR OTHERWISE CONTAINING MATERIAL FROM CATTLE Priority: Other Significant CFR Citation: 21 CFR 189.5; 21 CFR 700.27 Completed: ________________________________________________________________________ Reason Date FR Cite ________________________________________________________________________ Final Action 10/11/06 71 FR 59653 Regulatory Flexibility Analysis Required: No Small Entities Affected: Businesses Government Levels Affected: None Agency Contact: Rebecca Buckner Phone: 301 436-1486 Fax: 301 436-2632 Email: rebecca.buckner@fda.hhs.gov RIN: 0910-AF48 _______________________________________________________________________ Department of Health and Human Services (HHS) Proposed Rule Stage Health Resources and Services Administration (HRSA) _______________________________________________________________________ 1095. 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 12/00/06 Regulatory Flexibility Analysis Required: No Government Levels Affected: None [[Page 73240]] 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 _______________________________________________________________________ Department of Health and Human Services (HHS) Final Rule Stage Health Resources and Services Administration (HRSA) _______________________________________________________________________ 1096. NATIONAL PRACTITIONER DATA BANK FOR ADVERSE INFORMATION ON PHYSICIANS AND OTHER HEALTH CARE PRACTITIONERS: REPORTING ADVERSE AND NEGATIVE ACTIONS Priority: Other Significant 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 03/21/06 71 FR 14135 Final Action 12/00/06 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 _______________________________________________________________________ 1097. 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 an equitable transplant system; that those policies are enforceable; and that patients and physicians have timely access to accurate data that will assist them in making decisions regarding intestinal transplantation. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 11/23/05 70 FR 70765 NPRM Comment Period End 01/23/06 Final Rule 12/00/06 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 _______________________________________________________________________ 1098. 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 Rule 12/00/06 Regulatory Flexibility Analysis Required: No [[Page 73241]] Small Entities Affected: No Government Levels Affected: None Agency Contact: Jose Rafael Morales, Acting Director, Division of Community Based Programs, Department of Health and Human Services, Health Resources and Services Administration, 5600 Fishers Lane, Room 7A-21, Rockville, MD 20857 Phone: 301 443-3650 Email: jmorales@hrsa.gov RIN: 0906-AA65 _______________________________________________________________________ 1099. NATIONAL VACCINE INJURY COMPENSATION PROGRAM: CALCULATION OF AVERAGE COST OF A HEALTH INSURANCE POLICY Priority: Other Significant 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, ``If, 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 cost 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 06/09/06 71 FR 33420 Final Action 12/00/06 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 _______________________________________________________________________ 1100. HEALTHY TOMORROW'S PARTNERSHIP FOR CHILDREN (HTPC) PROGRAM Priority: Other Significant 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 12/27/05 70 FR 76435--76436 NPRM Comment Period End 02/27/06 Final Rule 01/00/07 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Jose Belardo, Director, Healthy Tomorrow's Partnership for [[Page 73242]] 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) Long-Term Actions Health Resources and Services Administration (HRSA) _______________________________________________________________________ 1101. 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 _______________________________________________________________________ 1102. OPERATION OF THE ORGAN PROCUREMENT AND TRANSPLANTATION NETWORK (OPTN) Priority: Other Significant. Major status under 5 USC 801 is undetermined. Legal Authority: 42 USC 274e, sec 301, 1984; 42 USC 273 to 274d, sec 371 to 376; 42 USC 1320b-8, sec 1138 CFR Citation: 42 CFR 121 Legal Deadline: None Abstract: The Department of Health and Human Services (HHS) proposes to amend the final rule governing the operation of the OPTN. This notice of proposed rulemaking provides the legislative and regulatory history of the current rule, the factors that persuaded HHS of the advisability of amending the final rule governing the operation of the OPTN, and the anticipated consequences of this proposal. As required rapid changes in response to better understanding of the clinical scientific issues have become evident, HHS has determined that the current process for approving and enforcing policies must be amended. Timetable: Next Action Undetermined Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Dr. Hui-Hsing Wong, Medical Officer, Department of Health and Human Services, Health Resources and Services Administration, 5600 Fishers Lane, Mail Stop 16C-17, Parklawn Bldg., Rockville, MD 20857 Phone: 301 443-8104 Fax: 301 594-6095 Email: hwong@hrsa.gov RIN: 0906-AA63 _______________________________________________________________________ Department of Health and Human Services (HHS) Completed Actions Health Resources and Services Administration (HRSA) _______________________________________________________________________ 1103. SMALLPOX VACCINE INJURY COMPENSATION PROGRAM: SMALLPOX (VACCINIA) VACCINE INJURY TABLE Priority: Other Significant CFR Citation: 42 CFR 102 Completed: ________________________________________________________________________ Reason Date FR Cite ________________________________________________________________________ Final Rule 05/24/06 71 FR 29805 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Paul T. Clark Phone: 301 443-5255 Email: smallpox@hrsa.gov Related RIN: Related to 0906-AA61 RIN: 0906-AA60 _______________________________________________________________________ 1104. SMALLPOX VACCINE INJURY COMPENSATION PROGRAM: ADMINISTRATIVE IMPLEMENTATION Priority: Other Significant CFR Citation: 42 CFR 102 Completed: ________________________________________________________________________ Reason Date FR Cite ________________________________________________________________________ Final Rule 05/24/06 71 FR 29808 Regulatory Flexibility Analysis Required: No [[Page 73243]] Small Entities Affected: No Government Levels Affected: None Agency Contact: Paul T. Clark Phone: 301 443-5255 Email: smallpox@hrsa.gov Related RIN: Related to 0906-AA60 RIN: 0906-AA61 _______________________________________________________________________ Department of Health and Human Services (HHS) Final Rule Stage Indian Health Service (IHS) _______________________________________________________________________ 1105. SECTION 506--LIMITATION ON CHARGES FOR SERVICES FURNISHED BY MEDICARE-PARTICIPATING INPATIENT HOSPITAL TO INDIANS Priority: Other Significant 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 04/28/06 71 FR 25124 NPRM Comment Period End 06/27/06 Final Action 04/00/07 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) _______________________________________________________________________ 1106. GRANTS FOR RESEARCH PROJECTS 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 12/00/06 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, 6011 Executive Boulevard, Rockville, MD 20852 Phone: 301 496-4606 Fax: 301 402-0169 Email: jm40z@nih.gov RIN: 0925-AA42 _______________________________________________________________________ 1107. NATIONAL INSTITUTES OF HEALTH LOAN REPAYMENT PROGRAMS Priority: Substantive, Nonsignificant Legal Authority: 42 USC 216; 42 USC 288-5a; 42 USC 287c-33; 42 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 (LRP) authorities. This action will include rescinding the current regulations at 42 CFR 68a and at 42 CFR 68c replaced by 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 01/00/07 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, 6011 Executive Boulevard, Rockville, MD 20852 Phone: 301 496-4606 Fax: 301 402-0169 Email: jm40z@nih.gov RIN: 0925-AA43 _______________________________________________________________________ 1108. 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 [[Page 73244]] 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 03/00/07 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, 6011 Executive Boulevard, Rockville, MD 20852 Phone: 301 496-4606 Fax: 301 402-0169 Email: jm40z@nih.gov RIN: 0925-AA44 _______________________________________________________________________ 1109. 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 03/00/07 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, 6011 Executive Boulevard, Rockville, MD 20852 Phone: 301 496-4606 Fax: 301 402-0169 Email: jm40z@nih.gov RIN: 0925-AA45 _______________________________________________________________________ 1110. NATIONAL INSTITUTE OF ENVIRONMENTAL HEALTH SCIENCES HAZARDOUS SUBSTANCES BASIC RESEARCH AND TRAINING GRANTS Priority: Substantive, Nonsignificant Legal Authority: 42 USC 216; 42 USC 9660(a) 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 03/00/07 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, 6011 Executive Boulevard, Rockville, MD 20852 Phone: 301 496-4606 Fax: 301 402-0169 Email: jm40z@nih.gov RIN: 0925-AA46 _______________________________________________________________________ 1111. ENDOWMENT PROGRAM Priority: Substantive, Nonsignificant Legal Authority: 42 USC 216; 42 USC 287c-31 CFR Citation: Not Yet Determined Legal Deadline: None Abstract: The Director of the National Center for Minority Health and Disparities Research is authorized under section 485E(h)(1) of the Public Health Service Act to carry out a program to facilitate minority health disparities research and other health disparities research by providing for research endowments at centers of excellence under section 736 (Public Health Service Act). NIH plans to issue implementing regulations to govern these research endowments. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 12/00/06 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, 6011 Executive Boulevard, Rockville, MD 20852 Phone: 301 496-4606 Fax: 301 402-0169 Email: jm40z@nih.gov RIN: 0925-AA47 _______________________________________________________________________ 1112. UNDERGRADUATE SCHOLARSHIP PROGRAM REGARDING PROFESSIONS NEEDED BY THE NATIONAL INSTITUTES OF HEALTH Priority: Substantive, Nonsignificant. Major status under 5 USC 801 is undetermined. Legal Authority: 42 USC 216; 42 USC 288-4 CFR Citation: 42 CFR 68b Legal Deadline: None Abstract: Section 487D of the Public Health Service Act, as added by NIH Revitalization Act of 1993, creates a program offering scholarships to individuals from disadvantaged backgrounds who are enrolled as full- time students at accredited institutions pursuing academic programs appropriate for careers in professions needed by NIH. For each year of scholarship support, the recipient agrees to service (employment) after graduation, at NIH, for one year. Additionally, the individual agrees to at least 10 consecutive weeks of service [[Page 73245]] (employment) at NIH during which the individual is attending the educational institution and receiving the NIH scholarship. The proposed new regulations will govern this program. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 03/00/07 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, 6011 Executive Boulevard, Rockville, MD 20852 Phone: 301 496-4606 Fax: 301 402-0169 Email: jm40z@nih.gov RIN: 0925-AA48 _______________________________________________________________________ 1113. [bull] NIH TRAINING GRANTS Priority: Substantive, Nonsignificant Legal Authority: 42 USC 216; 42 USC 285q-1; 42 USC 287c-32 CFR Citation: 42 CFR 63a Legal Deadline: None Abstract: NIH plans to amend the agency's existing training grants regulations to (1) reflect their applicability to the training authorities set forth in PHS's ACT sections 464W and 485F, (2) reflect their applicability to the National Center on Minority Health and Health Disparities (NCMHD)'s and Fogarty International Center (FIC)'s Minority Health and Health Disparities International Research Training (MHIRT) awards, and (3) revise the definition of program director to mean one or more individuals named by the grantee in the grant application and approved by the Secretary, who is responsible for the management and conduct of the training program, rather than limiting the role of program director to a single individual when that more accurately reflects the management needs of a training program. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 03/00/07 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, 6011 Executive Boulevard, Rockville, MD 20852 Phone: 301 496-4606 Fax: 301 402-0169 Email: jm40z@nih.gov RIN: 0925-AA49 _______________________________________________________________________ 1114. [bull] NIH CENTER GRANTS Priority: Substantive, Nonsignificant Legal Authority: 42 USC 216; 42 USC 287c-21h; 42 USC 241 CFR Citation: 42 CFR 57a Legal Deadline: None Abstract: NIH plans to amend the Agency's existing center grant regulations by revising section 52a.1 to reflect the applicability of the regulations to (1) The program of research centers on complementary and alternative medicine administered by the National Center for Complementary and Alternative Medicine (NCCAM), and (2) the regional centers of excellence for biodefense and emerging infectious diseases research administered by the National Institute of Allergy and Infectious Diseases (NIAID). Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 03/00/07 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, 6011 Executive Boulevard, Rockville, MD 20852 Phone: 301 496-4606 Fax: 301 402-0169 Email: jm40z@nih.gov RIN: 0925-AA50 _______________________________________________________________________ 1115. [bull] NIH CONSTRUCTION GRANT Priority: Substantive, Nonsignificant Legal Authority: 42 USC 216 CFR Citation: 42 CFR 52b Legal Deadline: None Abstract: NIH plans to amend the Agency's existing construction grant regulations by revising language concerning recovery set forth in 42 CFR part 52b(a)(1) and insurance coverage set forth in 42 CFR part 52b, 10(n) to make the language more consistent with the language set forth in the Department's regulations at 45 CFR part 74.32 and 45 CFR part 74.31, respectively. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 03/00/07 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, 6011 Executive Boulevard, Rockville, MD 20852 Phone: 301 496-4606 Fax: 301 402-0169 Email: jm40z@nih.gov RIN: 0925-AA51 _______________________________________________________________________ Department of Health and Human Services (HHS) Final Rule Stage National Institutes of Health (NIH) _______________________________________________________________________ 1116. 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. [[Page 73246]] Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 01/11/05 70 FR 1843 Final Action 12/00/06 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, 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) _______________________________________________________________________ 1117. NATIONAL INSTITUTES OF HEALTH TRAINING GRANTS Priority: Substantive, Nonsignificant CFR Citation: 42 CFR 63a Completed: ________________________________________________________________________ Reason Date FR Cite ________________________________________________________________________ Final Action 06/26/06 71 FR 42296 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-AA28 _______________________________________________________________________ Department of Health and Human Services (HHS) Prerule Stage Office of Public Health and Science (OPHS) _______________________________________________________________________ 1118. 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 To Be Determined Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Julie A. Kaneshiro, Department of Health and Human Services, Office of Public Health and Science, The Tower Building, 1101 Wootton Parkway, Suite 200, Rockville, MD 20852 Phone: 240 452-6900 Fax: 301 402-2071 Email: julie.kaneshiro@hhs.gov RIN: 0940-AA11 _______________________________________________________________________ Department of Health and Human Services (HHS) Final Rule Stage Office of Public Health and Science (OPHS) _______________________________________________________________________ 1119. 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 [[Page 73247]] system, the submission of certain registration information is required by human subjects protection regulations, and certain other information may be submitted voluntarily. This proposed information collection was submitted to the Office of Management and Budget under the Paperwork Reduction Act. Under the proposed rule, all registration information will be required, making the IRB registration system uniform with IRB registration requirements of the Food and Drug Administration (FDA), and creating a single, HHS IRB Registration system. FDA simultaneously published a proposed rule regarding FDA IRB registration requirements. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 07/04/04 69 FR 40584 NPRM Comment Period End 10/04/04 Final Action 04/00/07 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, The Tower Building, 1101 Wootten Parkway, Rockville, MD 20852 Phone: 240 453-6900 Fax: 301 402-2071 Email: irene.stith-coleman@hhs.gov RIN: 0940-AA06 _______________________________________________________________________ Department of Health and Human Services (HHS) Long-Term Actions Office of Public Health and Science (OPHS) _______________________________________________________________________ 1120. 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 sec 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 12/00/07 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, 1101 Wootten Parkway, Rockville, MD 20852 Phone: 240 453-8200 Fax: 301 443-5351 Related RIN: Related to 0940-AA04 RIN: 0940-AA01 _______________________________________________________________________ 1121. 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 ________________________________________________________________________ ANPRM To Be Determined Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Elyse Summers, Department of Health and Human Services, Office of Public Health and Science, The Tower Building, 1101 Wootten Parking, Rockville, MD 20852 Phone: 240 453-6900 Email: elyse.summers@hhs.gov RIN: 0940-AA08 [[Page 73248]] _______________________________________________________________________ Department of Health and Human Services (HHS) Proposed Rule Stage Centers for Medicare & Medicaid Services (CMS) _______________________________________________________________________ 1122. 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;409;418 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 our efforts to achieve broad-based improvements and measurements of the quality of care furnished through Federal programs while at the same time reducing procedural burdens on providers. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 03/10/97 62 FR 11005 NPRM Comment Period End 06/09/97 Second NPRM 05/00/07 Regulatory Flexibility Analysis Required: No Small Entities Affected: Businesses, Organizations Government Levels Affected: None Agency Contact: Lieutenant 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 Commander 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 _______________________________________________________________________ 1123. APPEALS OF CMS OR CONTRACTOR DETERMINATIONS WHEN A PROVIDER OR SUPPLIER FAILS TO MEET THE REQUIREMENTS FOR MEDICARE BILLING (CMS-6003- P2) Priority: Substantive, Nonsignificant Legal Authority: 42 USC 1302; 42 USC 1395u(b)(3)(C); 42 USC 1395ff(b) and 1395hh CFR Citation: 42 CFR 405.874; 42 CFR 424.525; 42 CFR 424.535; 42 CFR 424.545; 42 CFR 498.1; 42 CFR 498.2; 42 CFR 498.5; 42 CFR 498.22; 42 CFR 498.40; 42 CFR 498.44; 42 CFR 498.56; 42 CFR 498.78; 42 CFR 498.79; 42 CFR 498.86; 42 CFR 498.89; . . . 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 03/00/07 Regulatory Flexibility Analysis Required: No Small Entities Affected: Businesses Government Levels Affected: None Agency Contact: August Nemec, 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: 410 786-0612 Email: august.nemec@cms.hhs.gov RIN: 0938-AI49 _______________________________________________________________________ 1124. 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. In light of the fact that section 902 of MMA of 2003 requires the Secretary to issue regulations within 3 years, CMS is republishing the provisions of the final RHC rule as a proposed rule to provide the public with an opportunity to formally comment on the new policies established under the December 24, 2003 rule. In addition, we are proposing new policy revisions to the RHC and FQHC program to improve and strengthen this rural safety net benefit. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 12/24/03 68 FR 74792 Interim Final Rule 09/22/06 71 FR 55341 Interim Final Rule Comment Period End 11/21/06 Second NPRM 02/00/07 Regulatory Flexibility Analysis Required: No [[Page 73249]] Small Entities Affected: Businesses Government Levels Affected: Federal Agency Contact: Amy Bassano, Director, Division of Ambulatory Services, Hospital and Ambulatory Policy Group, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Mailstop C4-02-14, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786-3028 Email: amy.bassano@cms.hhs.gov RIN: 0938-AJ17 _______________________________________________________________________ 1125. USE OF RESTRAINTS AND SECLUSION IN MEDICARE AND MEDICAID PARTICIPATING FACILITIES THAT PROVIDE INPATIENT OR RESIDENTIAL CARE (CMS-2130-P) Priority: Other Significant Legal Authority: PL 106-554, (BIPA 2000 of the Children's Health Act) CFR Citation: 45 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 02/00/07 Regulatory Flexibility Analysis Required: Undetermined Small Entities Affected: Businesses Government Levels Affected: Undetermined Federalism: Undetermined Agency Contact: Carla McGregor, Health Insurance Specialist, Survey and 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 _______________________________________________________________________ 1126. REVISIONS TO CONDITIONS FOR COVERAGE FOR AMBULATORY SURGICAL CENTERS (CMS-3887-P) Priority: Other Significant. Major under 5 USC 801. 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 06/00/07 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 Commander 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: jacqueline.morgan@cms.hhs.gov RIN: 0938-AL80 _______________________________________________________________________ 1127. 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: Not Yet Determined Legal Deadline: None Abstract: This proposed rule would streamline the adoption process for electronic transactions and code set standards mandated by the Health Insurance Portability and Accountability Act of 1996, and provide certain other technical corrections and clarifications to the regulations. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 06/00/07 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 _______________________________________________________________________ 1128. REQUIREMENTS FOR LONG-TERM CARE FACILITIES: HOSPICE SERVICES (CMS- 3140-P) Priority: Other Significant 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 long-term care (LTC) facilities must have an agreement with hospice agencies when hospice care is provided in a long-term care facility 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 02/00/07 [[Page 73250]] 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 _______________________________________________________________________ 1129. 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 03/00/07 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses, Governmental Jurisdictions, Organizations Government Levels Affected: Federal, Local, State, Tribal Federalism: This action may have federalism implications as defined in EO 13132. Energy Effects: Statement of Energy Effects planned as required by Executive Order 13211. Agency Contact: 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 _______________________________________________________________________ 1130. NATIONAL PLAN AND PROVIDER ENUMERATION SYSTEM (NPPES) DATA DISSEMINATION (CMS-6060-NC) Priority: Other Significant 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 with comment period 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 describes the data dissemination strategy, processes, and any applicable charges for data. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Notice 01/00/07 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Patrica Peyton, 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: 410 786-1812 Email: patrica.peyton@cms.hhs.gov RIN: 0938-AN71 _______________________________________________________________________ 1131. 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 06/00/07 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Captain Arnold C. Farley, 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: 410 786-1154 Email: arnold.farley@cms.hhs.gov RIN: 0938-AN73 [[Page 73251]] _______________________________________________________________________ 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: This proposed rule would require all long-term care facilities to be equipped with sprinkler systems. This proposed rule requests public comment, including comment on the duration of a phase- in period, to allow long-term care facilities to install such systems. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 10/27/06 71 FR 62957 NPRM Comment Period End 12/26/06 Final Action 10/00/09 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. 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: None CFR Citation: 42 CFR 435 Legal Deadline: None Abstract: The proposed rule would clarify that Federal Financial Participation (FFP) is not available to States on behalf of Medicaid beneficiaries for Medicaid-covered services provided without charge (that is, free care) to individuals receiving the services. Free care means a particular service is available without charge to an individual who receives the service or to any third party on behalf of the individual. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 01/00/07 Regulatory Flexibility Analysis Required: Undetermined Small Entities Affected: Governmental Jurisdictions Government Levels Affected: Undetermined Federalism: Undetermined Agency Contact: Melissa L. Harris, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Disability & Elderly Health Programs Group, Mailstop S2-14-26, 7500 Security Boulevard, Baltimore, MD 21244-1850 Phone: 410 786-3397 Email: melissa.harris@cms.hhs.gov RIN: 0938-AO07 _______________________________________________________________________ 1134. 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 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 07/00/07 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 _______________________________________________________________________ 1135. OUTPATIENT HOSPITAL SERVICES AND RURAL HEALTH CLINIC SERVICES AMENDMENT (CMS-2213-P) Priority: Economically Significant. Major under 5 USC 801. Legal Authority: sec 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 06/00/07 Regulatory Flexibility Analysis Required: Undetermined Small Entities Affected: Businesses Government Levels Affected: None Federalism: Undetermined Agency Contact: Jeremy Silanskis, Health Insurance Specialist, 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 [[Page 73252]] Phone: 410 786-1592 Fax: 410 786-8533 Email: jeremy.silanskis@cms.hhs.gov RIN: 0938-AO17 _______________________________________________________________________ 1136. MEDICAID PRESCRIPTION DRUGS -- AVERAGE MANUFACTURER PRICE (CMS- 2238-P) Priority: Other Significant. Major status under 5 USC 801 is undetermined. Legal Authority: 42 USC 1396r.8; Deficit Reduction Act of 2005, PL 109- 171, sec 6001 to 6003 CFR Citation: 42 CFR 447.535 Legal Deadline: Final, Statutory, January 1, 2007. Abstract: This proposed rule would implement sections 6001, 6002, and 6003 of the Deficit Reduction Act of 2005. This rule would set the Federal upper reimbursement limit (FUL) as 250 percent of the average manufacturer price (AMP) for drugs on the FUL list, and would clarify the requirements and manner in which AMPs are determined for multiple source drugs and other drug payment revisions. This rule would also list the physician administered multiple source drugs that the Secretary determines have the highest dollar volume of dispensing in Medicaid and would require manufacturers to include authorized generics when they report their AMP and best price for covered outpatient drugs to the Secretary. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 12/00/06 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: State Agency Contact: Yolanda Lashawn Reese, Health Insurance Specialist, Division of Benefits and Coverage Policy Services, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Center for Medicaid and State Operations, Mailstop S2-06-15, 7500 Security Boulevard, Baltimore, MD 21244-1850 Phone: 410 786-9898 Fax: 410 786-5882 Email: yolanda.reese@cms.hhs.gov RIN: 0938-AO20 _______________________________________________________________________ 1137. 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 401.601, 42 CFR 401.607 Legal Deadline: Final, Statutory, December 9, 2003. Abstract: This proposed rule would modify Medicare regulations to implement a provision of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 pertaining to the use of repayment plans (also known as extended repayment schedules). Under this provision, we propose to grant a provider or a supplier an extended repayment schedule under certain terms and conditions as defined in the statute. The proposed rule would establish criteria and procedures to apply this requirement and to define the concepts of ``hardship'' and ``extreme hardship.'' Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 12/00/06 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 _______________________________________________________________________ 1138. REDISTRIBUTION OF UNEXPENDED STATE CHILDREN'S HEALTH INSURANCE PROGRAM (SCHIP) FUNDS FROM THE APPROPRIATION FOR FISCAL YEAR 2004 (CMS- 2241-NC) Priority: Other Significant Legal Authority: 42 USC 1397dd(g); 42 USC 1397ee(g); secs 2104(e) & (f) of the Social Security Act CFR Citation: 42 CFR 457.600-630 Legal Deadline: None Abstract: This notice announces the procedure for redistribution of States' unexpended FY 2004 allotments that remained at the end of FY 2004 to those States that fully expended the FY 2004 SCHIP allotment. These redistributed allotments will be available through the end of FY 2007. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 03/00/07 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: Undetermined Federalism: Undetermined Agency Contact: Richard Strauss, Technical Director, Finance Systems & Budget Group, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Centers for Medicaid and State Operations, Mailstop, C5-22-25, 7500 Security Boulevard, Baltimore, MD 21244-1850 Phone: 410 786-2019 Email: richard.strauss@cms.hhs.gov RIN: 0938-AO28 _______________________________________________________________________ 1139. PROSPECTIVE PAYMENT SYSTEM FOR LONG-TERM CARE HOSPITALS RY 2008: ANNUAL PAYMENT RATE UPDATES (CMS-1529-P) Regulatory Plan: This entry is Seq. No. 44 in part II of this issue of the Federal Register. RIN: 0938-AO30 _______________________________________________________________________ 1140. HOME HEALTH PROSPECTIVE PAYMENT SYSTEM RATE UPDATE FOR CALENDAR YEAR 2008 (CMS-1541-P) Priority: Economically Significant. Major under 5 USC 801. Legal Authority: Social Security Act, sec 1102 and 1871; (42 USC 1302 and 1395 (hh)) CFR Citation: 42 CFR 484 Legal Deadline: Final, Statutory, January 1, 2008. Abstract: This proposed rule would update the 60-day national episode rate and the national per-visit rate amounts [[Page 73253]] under the Medicare Prospective Payment System for home health agencies, effective January 1, 2008. This rule would also propose the first major refinement to the HHPPS since its implementation on October 1, 2001. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 05/00/07 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: None Agency Contact: Randy L. Throndset, Technical Advisor, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Mailstop C5-02-03, 7500 Security Boulevard, Baltimore, MD 21244-1850 Phone: 410 786-0131 Email: randy.throndset@cms.hhs.gov RIN: 0938-AO32 _______________________________________________________________________ 1141. GYNECOLOGICAL CYTOLOGY PROFICIENCY TESTING REQUIREMENTS FOR LABORATORIES, INDIVIDUALS, AND PROFICIENCY TESTING PROGRAM APPROVALS (CMS-2252-P) Priority: Other Significant Legal Authority: 42 USC 263a, Clinical Laboratory Improvement Amendments of 1988; 42 USC 1395x secs 1861s(15) through 1861s(17) CFR Citation: 42 CFR 493 Legal Deadline: None Abstract: This proposed rule would revise certain participation requirements for clinical laboratories offering cytology services and individuals examining gynecological cytology specimens; and CMS- approval requirements for programs offering proficiency testing for gynecologic cytology under the Clinical Laboratory Improvement Amendments (CLIA) of 1988 program. Evaluating the competency of each individual who examines gynecologic cytology specimens (pap smears) is required by Federal law and regulations. Failure to publish this rule could result in the failure to identify individuals who cannot competently and accurately examine pap smears, or failure to demonstrate a need for continual education. Identifying these individuals is essential in providing quality patient care. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 07/00/07 Regulatory Flexibility Analysis Required: Undetermined Small Entities Affected: Businesses Government Levels Affected: None Federalism: Undetermined Agency Contact: Cheryl B. Wiseman, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Centers for Medicare & Medicare Services, Mailstop, S2-12-25, 7500 Security Boulevard, Baltimore, MD 21244-1850 Phone: 410 786-3340 Email: cheryl.wiseman@cms.hhs.gov RIN: 0938-AO34 _______________________________________________________________________ 1142. STATE OPTION TO ESTABLISH NON-EMERGENCY MEDICAL TRANSPORTATION PROGRAM (CMS-2234-P) Priority: Other Significant Unfunded Mandates: Undetermined Legal Authority: Deficit Reduction Act of 2005 (PL 109-171), sec 6083 CFR Citation: Not Yet Determined Legal Deadline: Final, Statutory, February 8, 2006. Abstract: Enactment of section 6083 of the Deficit Reduction Act of 2005 (DRA amends section 1902(a)of the Social Security Act (the Act) by adding a new section 1902(a)(70) that provides States with the ability to establish, under the State plan, a non-emergency medical transportation (NEMT) brokerage program. Such a program may be managed through a contract with a broker(s), as a method of assuring NEMT services for beneficiaries who need access to medical care, but have no other means of transportation. A regulation is needed in order to implement this provision of the DRA. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 02/00/07 Regulatory Flexibility Analysis Required: Undetermined Government Levels Affected: Undetermined Federalism: Undetermined Agency Contact: Jean Sheil, Director, Family and Children's Health Programs Group, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Center for Medicaid State Operations, Mailstop S2-01-16, 7500 Security Boulevard, Baltimore, MD 21244-1850 Phone: 410 786-5647 Fax: 410-786-8534 Email: jean.sheil@cms.hhs.gov RIN: 0938-AO45 _______________________________________________________________________ 1143. COST SHARING OPTIONS (CMS-2244-P) Priority: Other Significant. Major status under 5 USC 801 is undetermined. Unfunded Mandates: Undetermined Legal Authority: Deficit Reduction Act of 2005, PL 109-171 CFR Citation: Not Yet Determined Legal Deadline: Final, Statutory, March 31, 2006, sec 6041 and 6042. Final, Statutory, January 1, 2007, sec 6043. Abstract: This rule would incorporate sections 6041, 6042, and 6043 of the Deficit Reduction Act of 2005 (DRA), which provides State Medicaid agencies with increased flexibility to implement premium and cost sharing requirements for certain Medicaid recipients. This authority is in addition to the current authority States already had under section 1916 of the Social Security Act to implement premiums and cost sharing. Sections 6041, 6042, and 6043 of the DRA provide States with additional State plan flexibility to implement alternative premiums for certain recipients and to implement alternative cost sharing for certain medical services, particularly non-preferred drugs and non-emergency care furnished in a hospital emergency department. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 02/00/07 Regulatory Flexibility Analysis Required: Undetermined Government Levels Affected: Undetermined Federalism: Undetermined Agency Contact: Jean Sheil, Director, Family and Childrens Health Programs Group, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Centers for Medicaid State Operations, Mailstop [[Page 73254]] S2-01-16, 7500 Security Boulevard, Baltimore, MD 21244-1850 Phone: 410 786-5647 Fax: 410 786-8534 Email: jean.sheil@cms.hhs.gov RIN: 0938-AO47 _______________________________________________________________________ 1144. STATE FLEXIBILITY FOR MEDICAID BENEFIT PACKAGES (CMS-2232-P) Priority: Economically Significant. Major under 5 USC 801. Unfunded Mandates: Undetermined Legal Authority: Deficit Reduction Act of 2005; sec 6044; sec 1102 of the Social Security Act CFR Citation: 42 CFR 440.300; 440, 385 Legal Deadline: Final, Statutory, March 31, 2006. Abstract: Enactment of section 6044 of the Deficit Reduction Act of 2005 (DRA) responds to State requests for additional flexibility by providing States with new options. For non-disabled, non-elderly persons who are eligible for Medicaid, the DRA allows States to follow the lead established by SCHIP and provide more flexible benefit packages that are more comparable to those in the private sector. Benchmark coverage is one of four types of coverage: Blue Cross/Blue Shield standard FEHBP coverage; State employee coverage; coverage of the largest commercial HMO in the states; and Secretary approved coverage. Children under age 19 enrolled in a benchmark plan will continue to receive EPSDT benefits through wrap-around coverage. A regulation is needed in order to implement this provision of the DRA. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 02/00/07 Regulatory Flexibility Analysis Required: Undetermined Government Levels Affected: Undetermined Federalism: Undetermined Agency Contact: Jean Sheil, Director, Family and Children's Health Programs Group, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Center for Medicaid State Operations, MailStop S2-01-16, 7500 Security Boulevard, Balitimore, MD 21244 Phone: 410 786-5647 Email: jean.sheil@cms.hhs.gov RIN: 0938-AO48 _______________________________________________________________________ 1145. HOME AND COMMUNITY-BASED SERVICES (HCBS) STATE PLAN OPTION (CMS- 2249-P) Priority: Other Significant. Major status under 5 USC 801 is undetermined. Unfunded Mandates: Undetermined Legal Authority: Deficit Reduction Act of 2005; (PL 109-171), sec 6086 CFR Citation: Not Yet Determined Legal Deadline: Final, Statutory, January 1, 2007. Abstract: The regulation would offer guidance to States on implementing the statutory provisions of section 6086 of the Deficit Reduction Act. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 04/00/07 Regulatory Flexibility Analysis Required: Undetermined Government Levels Affected: Undetermined Federalism: Undetermined Agency Contact: Theresa Pratt, Director, Division of Integrated Health Systems, Disabled and Elderly Health Programs Group, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Center for Medicaid State Operations, Mailstop S2-14-26, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786-9499 Email: theresa.pratt@cms.hhs.gov RIN: 0938-AO53 _______________________________________________________________________ 1146. [bull] MEDICARE PART D DATA (CMS-4119-P) Priority: Other Significant Legal Authority: 1860 D-15 of the Social Security Act CFR Citation: 42 CFR 423 Legal Deadline: None Abstract: CMS is required by Congress to conduct a number of Part D related research demonstration and evaluation studies that require Part D claims data. We are requesting that plans, on a voluntary basis, provide CMS with their approval to use claims and beneficiary risk score data for these studies to be conducted by CMS staff and contractors to better operate and/or improve the Medicare Part D program. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 10/18/06 71 FR 61445 NPRM Comment Period End 12/18/06 Final Action 10/00/09 Regulatory Flexibility Analysis Required: Undetermined Small Entities Affected: Organizations Government Levels Affected: None Agency Contact: Alissa M. Deboy, Acting Division Director, Center for Beneficiary Choices, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Drug Plan Policy and Analysis Division, Mailstop C1-26-16, 7500 Security Boulevard, Baltimore, MD 21244-1850 Phone: 410 786-6041 Email: alissa.deboy@cms.hhs.gov RIN: 0938-AO58 _______________________________________________________________________ 1147. [bull] PROSPECTIVE PAYMENT SYSTEM FOR INPATIENT REHABILITATION FACILITIES FOR FY 2008 (CMS-1551-P) Priority: Economically Significant. Major under 5 USC 801. Legal Authority: SSA, sec 1886(i); PL 105-33; PL 106-554; PL 106-113 CFR Citation: 42 CFR 412 Legal Deadline: Final, Statutory, August 1, 2007. Abstract: This proposed rule would update rates for the prospective payment system for inpatient rehabilitation facilities for FY 2008. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 05/00/07 Regulatory Flexibility Analysis Required: Undetermined Government Levels Affected: Undetermined Agency Contact: Bill Ullman, Division Director DHHS, CMS, Center for Medicare Management, Department of Health and Human Services, Centers for Medicare & Medicaid Services, C5-06-24, 7500 Security Blvd, Baltimore, MD 21244 Phone: 410 786-5667 [[Page 73255]] Email: bill.ullman@cms.hhs.gov RIN: 0938-AO63 _______________________________________________________________________ 1148. [bull] PROSPECTIVE PAYMENT SYSTEM AND CONSOLIDATED BILLING FOR SKILLED NURSING FACILITIES--UPDATE FOR FY 2008 (CMS-1545-P) Priority: Economically Significant. Major under 5 USC 801. Legal Authority: Social Security Act, sec 1888(e) CFR Citation: 42 CFR 424 Legal Deadline: Final, Statutory, July 31, 2007. Abstract: This rule proposes updates to the payment rates used under the SNF PPS beginning 10/1/07. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 05/00/07 Regulatory Flexibility Analysis Required: Undetermined Government Levels Affected: Undetermined Agency Contact: William Ullman, Health Insurance Specialist, Centers for Medicare Management, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Chronic Care Policy Group, Mailstop C5-07-08, 7500 Security Blvd, Baltimore, MD 21244 Phone: 410 786-5667 Email: bill.ullman@cms.hhs.gov RIN: 0938-AO64 _______________________________________________________________________ 1149. [bull] REVISIONS TO PAYMENT POLICIES UNDER THE PHYSICIAN FEE SCHEDULE FOR CALENDAR YEAR 2008 (CMS-1385-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, 2007. Abstract: This rule would make several changes affecting Medicare Part B payment. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 08/00/07 Regulatory Flexibility Analysis Required: Undetermined Government Levels Affected: Undetermined Federalism: Undetermined Agency Contact: Diane S. Milstead, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Centers for Medicaid Management, Mailstop C4-03-06, 7500 Security Blvd, Baltimore, MD 21244 Phone: 410 786-3355 Email: diane.milstead@cms.hhs.gov RIN: 0938-AO65 _______________________________________________________________________ 1150. [bull] STANDARDS FOR E-PRESCRIBING UNDER MEDICARE PART D (CMS- 0016-P) Regulatory Plan: This entry is Seq. No. 45 in part II of this issue of the Federal Register. RIN: 0938-AO66 _______________________________________________________________________ 1151. [bull] EXEMPTION OF PRIVACY ACT DISCLOSURE OF CERTAIN INVESTIGATIVE MATERIALS (CMS-0029-P) Priority: Info./Admin./Other Legal Authority: 5 USC 301; 5 USC 552a.45 CFR s 5b.11(b) (2)(ii)(H) CFR Citation: 45 CFR 5b Legal Deadline: None Abstract: Unrestricted disclosure of confidential information in CMS files can impede ongoing investigations, invade the personal privacy of individuals, reveal the identities of confidential sources, or otherwise impair the ability of CMS to conduct investigations. For these reasons this rule proposes to exempt the ASPEN Complaint/Incident Tracking System (ACTS), Organ Procurement Organizations Systems (OPOS), Fraud Investigation Database (FID), and HIPAA Information Tracking System (HITS) from the notification, access, correction and amendment provisions of the Privacy Act concerning records compiled for law enforcement purposes. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 02/00/07 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: Undetermined Federalism: Undetermined Agency Contact: Katherine Marie Brewer, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Mail Stop N2-04-27, 7500 Security Boulevard, Baltimore, MD 21244-1850 Phone: 410 786-7235 Fax: 410-786-5636 Email: katherine.brewer@cms.hhs.gov RIN: 0938-AO69 _______________________________________________________________________ 1152. [bull] CHANGES TO THE HOSPITAL INPATIENT PROSPECTIVE PAYMENT SYSTEMS AND FY 2008 RATES (CMS-1533-P) Regulatory Plan: This entry is Seq. No. 46 in part II of this issue of the Federal Register. RIN: 0938-AO70 _______________________________________________________________________ 1153. [bull] CHANGES TO THE HOSPITAL OUTPATIENT PROSPECTIVE PAYMENT SYSTEM AND CALENDAR YEAR 2008 PAYMENT RATES (CMS-1392-P) Priority: Economically Significant. Major under 5 USC 801. Legal Authority: BBA; BBRA; BIPA; MMA; DRA of 2005; . . . CFR Citation: 42 CFR 419 to 485 Legal Deadline: Final, Statutory, November 1, 2007. 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 Prescription Drug, Improvement, and 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 [[Page 73256]] payment system. These changes would be applicable to services furnished on or after 1/1/08. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 08/00/07 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: Federal Federalism: This action may have federalism implications as defined in EO 13132. Agency Contact: Alberta Dwivedi, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Mailstop C3-24-23, 7500 Security Boulevard, Baltimore, MD 21244-1850 Phone: 410 786-0763 Email: alberta.dwivedi@cms.hhs.gov RIN: 0938-AO71 _______________________________________________________________________ 1154. [bull] HOSPICE WAGE INDEX FOR FY 2008 (CMS-1539-P) Priority: Other Significant Legal Authority: 1814(i)(1) and 1814(i)(2) CFR Citation: 42 CFR 418 Legal Deadline: Final, Statutory, October 1, 2007. Abstract: This rule proposes the annual update to the hospice wage index for FY 2008. 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 ________________________________________________________________________ Notice 04/00/07 Regulatory Flexibility Analysis Required: Undetermined Small Entities Affected: Businesses Government Levels Affected: Undetermined Federalism: Undetermined Agency Contact: Terri Deutsch, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Division of Community Post Acute Care, Hospital and Ambulatory Policy Group, Mailstop C5-08-18, 7500 Security Blvd, Baltimore, MD 21244 Phone: 410 786-9462 Email: terri.deutsch@cms.hhs.cms RIN: 0938-AO72 _______________________________________________________________________ 1155. [bull] SPECIAL ENROLLMENT PERIOD AND MEDICARE PREMIUM CHANGES (CMS-4129-P) Priority: Other Significant. Major under 5 USC 801. Legal Authority: PL 109-171, sec 5115; PL 108-173, sec 811 CFR Citation: 42 CFR 406 to 408; 20 CFR 418 Legal Deadline: Final, Statutory, January 1, 2007. Abstract: Section 5115 of the Deficit Reduction Act of 2005 (DRA) provides a special enrollment period for Medicare Part B/premium Part A and waiver of late enrollment penalty and for individuals who are serving as a volunteer outside the United States through a program that covers at least a 12-month period and who have health insurance while providing the voluntary service outside of the United States. Section 811 of the Medicare Prescription Drug, Drug, Improvement, and Modernization Act (MMA) of 2003 as amended by section 5111 of the DRA requires an additional amount be assessed to the Part B premium of individuals who have a modified adjusted gross income that reaches certain levels. The effective date for these provisions is 1/1/07. Since SSA has the responsibility for calculating the additional premium amount, SSA will explain this statutory requirement in its part of the regulations (20 CFR 418). CMS will include a reference to the SSA regulation in its change to 42 CFR 408. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 07/00/07 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Sam DellaVecchia, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786-4481 Email: samuel.dellavecchia@cms.hhs.gov RIN: 0938-AO77 _______________________________________________________________________ 1156. [bull] REVISIONS TO THE MEDICARE ADVANTAGE AND PART D PRESCRIPTION DRUG CONTRACT CONFIDENTIALITY AND DISCLOSURE, DETERMINATIONS, APPEALS, AND INTERMEDIATE SANCTIONS PROCESSES (CMS-4124-P) Regulatory Plan: This entry is Seq. No. 47 in part II of this issue of the Federal Register. RIN: 0938-AO78 _______________________________________________________________________ Department of Health and Human Services (HHS) Final Rule Stage Centers for Medicare & Medicaid Services (CMS) _______________________________________________________________________ 1157. 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 [[Page 73257]] counseling; and maintain records for at least 10 years. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 11/16/00 65 FR 69416 Interim Final Rule 01/00/07 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 _______________________________________________________________________ 1158. USE OF RESTRAINTS 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, and 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 05/00/07 Regulatory Flexibility Analysis Required: No Small Entities Affected: Businesses Government Levels Affected: None Agency Contact: Thomas Shenk, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Division of Benefits & Coverage Policy, Mailstop S2-14-26, 7500 Security Boulevard, Baltimore, MD 21244-1850 Phone: 410 786-3295 Email: thomas.shenk@cms.hhs.gov RIN: 0938-AJ96 _______________________________________________________________________ 1159. 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 rule finalizes certain statutory provisions that prevent payment for services and impose penalties when a physician makes a referral to an entity in which that physician has a financial interest, unless an exception applies. It also addresses comments received on the ``Phase II'' Stark regulation published in the Federal Register on March 26, 2004. 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 _______________________________________________________________________ 1160. 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, Mailstop C4-25-02, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786-4477 Email: morton.marcus@cms.hhs.gov RIN: 0938-AL54 _______________________________________________________________________ 1161. 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, July 23, 2007, MMA sec. 902. Abstract: This final rule revises the CMS civil money penalty authorities. [[Page 73258]] These 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. This rule also finalizes an August 4, 2005, rule that outlines the process for health care providers to follow if they wish CMS to request a waiver of exclusion on their behalf. 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 Related RIN: Related to 0938-AN48 RIN: 0938-AM98 _______________________________________________________________________ 1162. ENHANCED DSH TREATMENT FOR CERTAIN HOSPITALS (CMS-2198-F) Priority: Other Significant Legal Authority: Section 1923(a)(2)(D)of the Social Security Act CFR Citation: 42 CFR 447; 42 CFR 455 Legal Deadline: Final, Statutory, December 8, 2003, Sec 1001(d) of MMA. Abstract: This rule implements section 1001(d) of the Medicare Prescription Drug Improvement, and Modernization Act of 2003, which requires States to report additional information about their disproportionate share hospital (DSH) programs in their annual report. This section also requires States to independently audit and submit these certified audits annually to the Secretary. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 08/26/05 70 FR 50262 Final Action 04/00/07 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 Phone: 410 786-3263 Email: james.frizzera@cms.hhs.gov RIN: 0938-AN09 _______________________________________________________________________ 1163. COMPETITIVE ACQUISITION FOR CERTAIN DURABLE MEDICAL EQUIPMENT (DME), PROSTHETICS, ORTHOTICS, AND SUPPLIES (CMS-1270-F) Regulatory Plan: This entry is Seq. No. 48 in part II of this issue of the Federal Register. RIN: 0938-AN14 _______________________________________________________________________ 1164. NONDISCRIMINATION IN HEALTH COVERAGE IN THE GROUP MARKET (CMS- 4081-F) Priority: Other Significant Legal Authority: 42 USC 300gg CFR Citation: 45 CFR 146.121 Legal Deadline: None Abstract: This final rule governs the provisions prohibiting discrimination based on a health factor for group health plans and issuers of health insurance coverage offered in connection with a group health plan. The rules contained in this document implement changes made to the Internal Revenue Code of 1986, 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. 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: Adam Shaw, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Center for Beneficiary Choices, Employer & Policy Operations Group, 7500 Security Boulevard, Baltimore, MD 21244-1850 Phone: 410 786-1091 Email: adam.shaw@cms.hhs.gov Karen Levin, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Center for Beneficiary Choices, Employer & Policy Operations Group, 7500 Security Boulevard, Baltimore, MD 21244-1850 Phone: 410 786-5445 Email: karen.levin@cms.hhs.gov Related RIN: Previously reported as 0938-AK19 RIN: 0938-AN29 _______________________________________________________________________ 1165. HOSPITAL CONDITIONS OF PARTICIPATION: PATIENTS' RIGHTS (CMS-3018- F) Priority: Other Significant 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 [[Page 73259]] used in the provision of acute medical and surgical care unless clinically necessary; and freedom from seclusion and restraint. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Interim Final Rule 07/02/99 64 FR 36069 Final Action 12/00/06 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None 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-AN30 _______________________________________________________________________ 1166. 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 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 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 _______________________________________________________________________ 1167. SPECIAL MEDICARE GME AFFILLATIONS FOR A TEACHING HOSPITAL AFFECTED BY A DISASTER (CMS-1531-F2) Priority: Other Significant Legal Authority: sec 1886(h)(d) of the Social Security Act CFR Citation: 42 CFR 413 Legal Deadline: None Abstract: This rule amends the current closed program regulations and Medicare affiliation agreement regulations to ameliorate the disruption in residency training caused by Hurricane Katrina and future emergency situations. Amendments to current closed program and Medicare affiliation agreement regulations will allow hospitals in areas affected by Hurricane Katrina and those hospitals adopting displaced residents, greater flexibility in maintaining Medicare funding during emergency situations. The amended regulations will go into effect during emergency situations as defined by the section 1135 emergency waiver invoked by the Secretary. Without changes to current regulations, adopting hospitals may be financially incapable of accepting displaced residents, home hospitals may have increased difficulty reopening residency training programs, and residents may be unable to continue with their planned residency training. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Interim Final Rule 04/12/06 71 FR 18654 Final Rule 07/06/06 71 FR 38264 Second Final Action 08/00/07 Regulatory Flexibility Analysis Required: No Small Entities Affected: Businesses Government Levels Affected: None Agency Contact: Tzvi Hefter, Director, Division of Acute Care, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Mail Stop C4-07-07, Centers for Medicare and Medicaid Services, 7500 Security Boulevard, Baltimore, MD 21244-1850 Phone: 410 786-6014 Email: tzvi.hefter@cms.hhs.gov RIN: 0938-AO35 _______________________________________________________________________ 1168. INPATIENT PSYCHIATRIC FACILITY PROSPECTIVE PAYMENT SYSTEM--UPDATE FOR RATE YEAR BEGINNING JULY 1, 2007 (RY 2008) (CMS-1479-N) Priority: Other Significant. Major status under 5 USC 801 is undetermined. Unfunded Mandates: Undetermined Legal Authority: PL 106-113, sec 124 BBRA CFR Citation: 42 CFR 412.400 subpart N Legal Deadline: Final, Statutory, July 1, 2007. Abstract: This notice updates the Inpatient Psychiatric Facility Prospective Payment System for 2008. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Notice 05/00/07 Regulatory Flexibility Analysis Required: Undetermined Small Entities Affected: Businesses Government Levels Affected: Local, State Federalism: Undetermined Agency Contact: Janet Samen, 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 21244-1850 Phone: 410 786-4533 Email: janet.samen@cms.hhs.gov RIN: 0938-AO40 [[Page 73260]] _______________________________________________________________________ 1169. GROUP HEALTH PLANS AND HEALTH INSURANCE ISSUES UNDER THE NEWBORNS AND MOTHERS HEALTH PROTECTION ACT (CMS-4116-F) Priority: Economically Significant. Major under 5 USC 801. Legal Authority: 42 USC 300gg to 300gg-63; 300gg-91 to 300gg-92 CFR Citation: 45 CFR 144; 45 CFR 146; 45 CFR 148 Legal Deadline: None Abstract: This final rule sets forth the post-childbirth hospitalization length of stay requirements for group health plans and health insurance issuers that cover such length of stays. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Final Action 09/00/07 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: Local, State Federalism: This action may have federalism implications as defined in EO 13132. Agency Contact: Adam Shaw, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Center for Beneficiary Choices, Employer & Policy Operations Group, Mailstop C5-14-15, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786-1091 Email: adam.shaw@cms.hhs.gov Karen B. Levin, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Center for Beneficiary Choices, Employer & Policy Operations Group, Mailstop C5- 14-15, 7500 Security Boulevard, Baltimore, MD 21244-1850 Phone: 410 786-5445 Email: karen.levin@cms.hhs.gov Related RIN: Related to 0938-AI17 RIN: 0938-AO43 _______________________________________________________________________ 1170. HIGH RISK POOLS (CMS-2260-IFC) Priority: Other Significant. Major under 5 USC 801. Unfunded Mandates: Undetermined Legal Authority: Deficit Reduction Act of 2005; (PL 109-171), sec 6202 CFR Citation: Not Yet Determined Legal Deadline: Final, Statutory, March 31, 2006. Abstract: Section 6202 of the Deficit Reduction Act of 2005 extends the funding and authorizes (H.R. 4519) and appropriates for FY 2006 $75 million for grants to help fund existing qualified State high risk pools and $15 million for grants to assist States to create and initially fund qualified high risk pools. The bill also authorizes appropriations of $75 million for each year FY 2007 through 2010. The section 6202 provision amendment to section 2745 establishes: (1) Seed grants to States for the creation and initial operation of a qualified high-risk pool for those States that do not have one, (2) grants to States to reimburse them for a percentage of losses incurred based on a methodology that allocates funding by 40 percent among all States, 30 percent to States based on their number of uninsured residents and 30 percent based on the number of people in State risk pools operating as an existing qualified high-risk pool during specified years and (3) bonus grants for supplemental consumer benefits. A regulation is needed in order to implement this provision of the DRA. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Interim Final Rule 02/00/07 Regulatory Flexibility Analysis Required: Undetermined Government Levels Affected: Undetermined Federalism: Undetermined Agency Contact: Jean Sheil, Director, Family and Children's Health Programs Group, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Centers for Medicaid Services Operations, Mailstop C2-01-16, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786-5647 Email: jean.sheil@cms.hhs.gov RIN: 0938-AO46 _______________________________________________________________________ 1171. TARGETED CASE MANAGEMENT (CMS-2237-IFC) Priority: Other Significant. Major under 5 USC 801. Legal Authority: Deficit Reduction Act of 2005; (PL 109-171), sec 6052 CFR Citation: 42 CFR 431, 440, 441 Legal Deadline: Final, Statutory, January 1, 2006. Abstract: This regulation is required by the Deficit Reduction Act. It clarifies what is reimbursable under the Medicaid case management and targeted case management benefit and is intended to offer guidance to States on implementing the statutory provision. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Interim Final Rule 01/00/07 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Theresa A. Pratt, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Mail Stop S2-14-26, 7500 Security Boulevard, Baltimore, MD 21244-1850 Phone: 410 786-5831 Email: theresa.pratt@cms.hhs.gov RIN: 0938-AO50 _______________________________________________________________________ 1172. CITIZENSHIP DOCUMENTATION REQUIREMENTS (CMS-2257-F) Priority: Other Significant Legal Authority: Deficit Reduction Act of 2005 (PL 109-171), sec 6036; sec 1102 of Social Security Act CFR Citation: 42 CFR 435.403; 42 CFR 435.1009; 42 CFR 435. 1010; 42 CFR 435.406; 42 CFR 435.407; 42 CFR 435.1002; 42 CFR 435.408; 42 CFR 435.1008; 42 CFR 435.1011; 42 CFR 436.406; 42 CFR 436.403; 42 CFR 436.407; 42 CFR 436.408; 42 CFR 436.1004; 42 CFR 436.1005; 42 CFR 440.2; 42 CFR 435.1009; 42 CFR 435.1010; 42 CFR 440.140; 42 CFR 440.180; 42 CFR 440.185; 42 CFR 441.13; 42 CFR 457.310; 42 CFR 483.5; 42 CFR 483.20; 42 CFR 483.102; 42 CFR 483.136; . . . Legal Deadline: Final, Statutory, July 1, 2006. [[Page 73261]] Abstract: Enactment of section 6036 of the Deficit Reduction Act of 2005 (DRA) requires that, effective July 1, 2006, all new applicants for Medicaid must, in addition to declaring that they are a citizen or national of the United States or an alien in a satisfactory immigration status, if claiming to be a citizen or national submit to the State evidence of citizenship. Since 1987, aliens claiming to be in a satisfactory immigration status have had to provide evidence of the claimed status and have that status verified with the Department of Homeland Security (previously the Immigration and Naturalization Service). A regulation is needed in order to implement this provision of the DRA. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Interim Final Rule Comment Period 07/12/06 71 FR 39214 Interim Final Rule Comment Period End 08/11/06 Final Action 08/00/07 Regulatory Flexibility Analysis Required: Undetermined Government Levels Affected: Undetermined Agency Contact: Jean Sheil, Director, Family and Children's Health Programs Group, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Centers for Medicaid States Operations, Mailstop S2-01-16, 7500 Security Boulevard, Baltimore, MD 21244-1850 Phone: 410 786-5957 Fax: 410 786-8534 Email: jean.sheil@cms.hhs.gov RIN: 0938-AO51 _______________________________________________________________________ 1173. SELF-DIRECTED PERSONAL ASSISTANCE SERVICES STATE PLAN OPTION (CMS- 2229-IFC) Priority: Other Significant Legal Authority: Deficit Reduction Act of 2005; (PL 109-171), sec 6087 CFR Citation: Not Yet Determined Legal Deadline: Final, Statutory, January 1, 2007. Abstract: The regulation is in support of the Deficit Reduction Act. Section 6087 allows a State to offer self-directed personal assistance services as a State Plan option and is intended to offer guidance to States on implementing the statutory provision. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Interim Final Rule 12/00/06 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: Federal, State Agency Contact: Theresa Pratt, Director, Division of Integrated Health Systems, Disabled and Elderly Health Programs Group, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Center for Medicaid State Operations, Mailstop S2-14-26, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786-9499 Email: theresa.pratt@cms.hhs.gov RIN: 0938-AO52 _______________________________________________________________________ 1174. [bull] INPATIENT HOSPITAL DEDUCTIBLE AND HOSPITAL AND EXTENDED CARE SERVICES COINSURANCE AMOUNTS FOR CY 2008 (CMS-8032-N) Priority: Other Significant Legal Authority: 42 USC 1395c-2 (b)(2), Social Security Act, sec 1813 (b)(2) CFR Citation: None Legal Deadline: Final, Statutory, September 15, 2007. Abstract: This notice announces the inpatient hospital deductible and the hospital and extended care services coinsurance amounts for services furnished in calendar year 2008 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 09/00/07 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Clare McFarland, Deputy Director, Medicare and Medicaid Cost Estimates Group, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Mailstop N3-26-00, Office of the Actuary, 7500 Security Boulevard, Baltimore, MD 21244-1850 Phone: 410 786-6390 Email: clare.mcfarland@cms.hhs.gov RIN: 0938-AO61 _______________________________________________________________________ 1175. [bull] PART A PREMIUMS FOR CY 2008 FOR THE UNINSURED AGED AND FOR CERTAIN DISABLED INDIVIDUALS WHO HAVE EXHAUSTED OTHER ENTITLEMENT (CMS- 8031-N) Priority: Other Significant 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 1818A (d)(2) CFR Citation: None Legal Deadline: Final, Statutory, September 30, 2007. Abstract: This notice announces the hospital insurance amount premium for calendar year 2008 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 09/00/07 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Clare McFarland, Deputy Director, Medicare and Medicaid Cost Estimates Group, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Mailstop N3-26-00, Office of the Actuary, 7500 Security Boulevard, Baltimore, MD 21244-1850 Phone: 410 786-6390 Email: clare.mcfarland@cms.hhs.gov RIN: 0938-AO62 _______________________________________________________________________ 1176. [bull] PART B MONTHLY ACTUARIAL RATES AND PREMIUM RATES BEGINNING JANUARY 1, 2008 (CMS-8033-N) Priority: Other Significant Legal Authority: 42 USC 1395 Social Security Act, section 1839; MMA, Section 629; MMA, Section 811; DRA, Section 511 CFR Citation: None Legal Deadline: Final, Statutory, September 30, 2007. [[Page 73262]] 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 calendar year 2008. It also announces the monthly Part B premiums and the Part B deductible during calendar year 2008. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Notice 09/00/07 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Suzanne Codespote, Deputy Director, Medicare and Medicaid Cost Estimates Group, Department of Health and Human Services, Centers for Medicare & Medicaid Services, N3-26-00, 7500 Seurity Boulevard, Baltimore, MD 21244 Phone: 410 786-7737 Email: suzanne.codespote@cms.hhs.gov RIN: 0938-AO68 _______________________________________________________________________ 1177. [bull] REVISED PAYMENT SYSTEM FOR SERVICES FURNISHED IN AMBULATORY SURGICAL CENTERS (ASCS) EFFECTIVE JANUARY 1, 2008 (CMS-1517-F) Priority: Economically Significant. Major under 5 USC 801. Unfunded Mandates: Undetermined Legal Authority: 1833(i)(2)(D)(iii) CFR Citation: 42 CFR 416 Legal Deadline: Final, Statutory, January 1, 2008. Abstract: This rule revises the method by which Medicare sets payment rates for ASC facility services, and includes new payment rates for ASC services in accordance with that methodology. This rule finalizes policies proposed as part of CMS-1506-P. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Final Action 11/00/07 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: State Agency Contact: Joan Sanow, Deputy Director, Division of Outpatient Services, Department of Health and Human Services, Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786-7802 Email: joan.sanow@cms.hhs.gov Related RIN: Split from 0938-AO15 RIN: 0938-AO73 _______________________________________________________________________ 1178. [bull] FISCAL YEAR 2008 SCHIP ALLOTMENTS (CMS-2262-N) Priority: Other Significant Legal Authority: Title XXI of the Social Security Act, sec 2104 CFR Citation: Not Yet Determined Legal Deadline: Final, Statutory, September 30, 2007. Abstract: This notice sets forth the final State Children's Health Insurance Program (SCHIP) 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 ________________________________________________________________________ Notice 08/00/07 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, Centers for Medicaid State Operations, Mailstop S3-13-15, 7500 Security Boulevard, Baltimore, MD 21244-1850 Phone: 410 786-2019 Fax: 410-786-0025 Email: richard.strauss@cms.hhs.gov RIN: 0938-AO76 _______________________________________________________________________ Department of Health and Human Services (HHS) Long-Term Actions Centers for Medicare & Medicaid Services (CMS) _______________________________________________________________________ 1179. 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 413, 42 CFR 414; 42 CFR 488 and CFR 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 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 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-AG82 [[Page 73263]] _______________________________________________________________________ 1180. HOSPITAL CONDITIONS OF PARTICIPATION: REQUIREMENTS FOR APPROVAL AND REAPPROVAL OF TRANSPLANT CENTERS TO PERFORM ORGAN TRANSPLANTS (CMS- 3835-F) Priority: Other Significant Legal Authority: 42 USC 1302; 42 USC 1395hh CFR Citation: 42 CFR 405; 42 CFR 482; 42 CFR 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 _______________________________________________________________________ 1181. 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 revises existing conditions of participation that hospices must meet to participate in the Medicare and Medicaid programs. The 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, and allow hospices greater flexibility in meeting quality standards. These changes are an integral part of our 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 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 21244-1850 Phone: 410 786-6051 Email: mary.rossicoajou@cms.hhs.gov Danielle Shearer, 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: 410 786-6617 Email: danielle.shearer@cms.hhs.gov RIN: 0938-AH27 _______________________________________________________________________ 1182. ELECTRONIC CLAIMS ATTACHMENTS STANDARDS (CMS-0050-F) 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 health care claims attachments. The standard is required by the Health Insurance Portability and Accountability Act of 1996. It will be used to transmit clinical or administrative data, in addition to the data contained in the claims standard, to help establish medical necessity or policy compliance 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: Stanley Nachimson, Senior Technical Advisor, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Office of E-Health Standards and Services, Mailstop S2-25-17, 7500 Security Boulevard, Baltimore, MD 21244-1850 Phone: 410 786-6153 Email: stanley.nachimson@cms.hhs.gov RIN: 0938-AK62 _______________________________________________________________________ 1183. 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 Action 12/00/07 Regulatory Flexibility Analysis Required: No Small Entities Affected: Businesses, Organizations [[Page 73264]] Government Levels Affected: Federal, Local, State Federalism: This action may have federalism implications as defined in EO 13132. Agency Contact: Adam Shaw, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Center for Beneficiary Choices, Employer & Policy Operations Group, 7500 Security Boulevard, Baltimore, MD 21244-1850 Phone: 410 786-1091 Email: adam.shaw@cms.hhs.gov Karen Levin, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Center for Beneficiary Choices, Employer & Policy Operations Group, 7500 Security Boulevard, Baltimore, MD 21244-1850 Phone: 410 786-5445 Email: karen.levin@cms.hhs.gov RIN: 0938-AL88 _______________________________________________________________________ 1184. 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, March 8, 2008, MMA sec 902. Abstract: This final rule revises 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 Second Interim Final Rule 06/30/05 70 FR 37700 Third Interim Final Rule 08/26/05 70 FR 50214 Final Action 03/00/08 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 Katherine L. Hosna, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Mailstop C2-12-16, 7500 Security Boulevard, Baltimore, MD 21244-1850 Phone: 410 786-4993 Email: katherine.hosna@cms.hhs.gov Related RIN: Related to 0938-AK69 RIN: 0938-AM73 _______________________________________________________________________ 1185. 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. Abstract: This rule reduces the burden on hospitals and allows hospitals to conform to current standards of practice. Hospitals must meet these final requirements to participate in Medicare and Medicaid programs. They must establish and maintain policies and procedures that will ensure their hospital will 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 _______________________________________________________________________ 1186. PRIOR DETERMINATION PROCESS FOR CERTAIN ITEMS AND SERVICES (CMS- 6024-F) Priority: Other Significant Legal Authority: Sec 938 of the Medicare Modernization Act of 2003 CFR Citation: 42 CFR 410 Legal Deadline: Final, Statutory, June 8, 2005. Abstract: Section 938 of the Medicare Modernization Act requires that physicians and beneficiaries be able to receive a prior determination regarding coverage of certain items and physicians' services beginning June 8, 2005. Full knowledge regarding financial liability for these services will be available to physicians and beneficiaries before expenses are incurred, although prior determination of coverage is not required for submission of a claim. 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: Debbie Skinner, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Program Integrity Goup, Office of Financial Management, Mailstop C3-02- 16, 7500 Security Boulevard, Baltimore, MD 21244-1850 Phone: 410 786-7480 Email: debbie.skinner@cms.hhs.gov RIN: 0938-AN10 [[Page 73265]] _______________________________________________________________________ 1187. MEDICARE SECONDARY PAYER AMENDMENTS (CMS-6272-F) 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: This final rule implements amendments to the Medicare Secondary Payer (MSP) provisions under title III of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA). The MMA amendments clarify the MSP provisions regarding the obligations of primary plans and primary payers, the nature of the insurance arrangements subject to the MSP rules, the circumstances under which Medicare may make conditional payments, and the obligations of primary payers to reimburse Medicare. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Interim Final Rule 02/24/06 71 FR 9466 Final Action 02/00/09 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Suzanne Ripley, Health Insurance Specialist, Office of Financial Management, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Mailstop C3-14-16, 7500 Security Boulevard, Baltimore, MD 21244-1850 Phone: 410 786-0970 Fax: 410 786-7030 Email: suzanne.ripley@cms.hhs.gov RIN: 0938-AN27 _______________________________________________________________________ 1188. TERMINATION OF NON-RANDOM PREPAYMENT MEDICAL REVIEW (CMS-6022-F) Priority: Other Significant Legal Authority: Sec 934 of the MMA CFR Citation: 42 CFR 421 Legal Deadline: Final, Statutory, October 7, 2008, MMA sec. 902. 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, 2003. 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 _______________________________________________________________________ 1189. LIMITATION ON RECOUPMENT OF OVERPAYMENTS (CMS-6025-F) Priority: Other Significant Legal Authority: Section 1893 (f) (2) of the Social Security Act added by Section 935 of the MMA CFR Citation: 42 CFR 405 Legal Deadline: Final, Statutory, December 8, 2003. Abstract: This rule implements one provision of section 935 of the Medicare Modernization Act which added a new subsection to section 1893 of the Social Security Act. It adjusts Medicare's ability to recover an overpayment when the Qualified Independent Contractor (QIC) receives a valid appeal from the provider or supplier. This rule defines the overpayments to which the limitation applies, how the limitation works in concert with the appeals process, and the change in Medicare's obligation to pay interest to a provider or supplier whose appeal is successful at levels above the QIC. This rule may cost a provider additional interest exposure if the provider appeals an overpayment; recoupment is stopped; and the overpayment is affirmed. The provider can avoid this by electing to pay the debt through a lump sum or in installments. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 09/22/06 71 FR 55404 NPRM Comment Period End 11/21/06 Final Action 09/00/09 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 _______________________________________________________________________ 1190. MEDICARE PART B COMPETITIVE ACQUISITION OF OUTPATIENT DRUGS AND BIOLOGICALS (CMS-1325-F) Priority: Other Significant Legal Authority: MMA of 2003, sec 303(d) CFR Citation: 42 CFR 414 Legal Deadline: Final, Statutory, July 1, 2006. 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 July 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 Second Interim Final Rule 09/06/05 70 FR 52930 Third Interim Final Rule 11/21/05 70 FR 70478 Fourth Interim Final Rule 08/18/06 71 FR 47870 [[Page 73266]] Fourth Interim Final Rule Comment Period End 10/02/06 Final Action 08/00/09 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: None Agency Contact: Corinne Axelrod, Health Insurance Specialist, Hospital & Ambulatory Policy Group, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Mailstop C5-14-03, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786-5620 Email: corinne.axelrod@cms.hhs.gov RIN: 0938-AN58 _______________________________________________________________________ 1191. 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: 42 CFR 400 and 421 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: Gary D. Williams, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Office of Financial Management, Mailstop C3-02-16, 7500 Security Boulevard, Baltimore, MD 21244-1850 Phone: 410 786-6433 Email: gary.williams4@cms.hhs.gov Related RIN: Related to 0938-AI09 RIN: 0938-AN72 _______________________________________________________________________ 1192. 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 Legal Deadline: Final, Statutory, October 1, 2005. Abstract: This rule sets forth the State requirements to provide information for purposes of estimating improper payments in Medicaid and SCHIP. The Improper Payments Information Act of 2002 (IPIA) requires heads of Federal agencies to annually estimate and report to the Congress these estimates of improper payments for the programs they oversee and submit a report on actions the Agency is taking to reduce erroneous payments. This rule also responds to the public comments on the October 5, 2005, interim final rule and sets forth State requirements for submitting claims and policies to the Federal contractor for purposes of conducting fee-for-service and managed care reviews. This rule also responds to public comments on the State requirements for conducting eligibility reviews and estimating payment error rates due to errors in eligibility determinations. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 08/27/04 69 FR 52620 Interim Final Rule 10/05/05 70 FR 58260 Second Interim Final Rule 08/28/06 71 FR 51049 Final Action 08/00/09 Regulatory Flexibility Analysis Required: No Government Levels Affected: State Agency Contact: Janet Reichert, Technical Advisor, 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: 410 786-4580 Email: janet.reichert@cms.hhs.gov Related RIN: Related to 0938-AM86 RIN: 0938-AN77 _______________________________________________________________________ 1193. NOTIFICATION PROCEDURES FOR HOSPITAL DISCHARGES (CMS-4105-F) Priority: Other Significant Legal Authority: 42 USC 1396ff CFR Citation: 42 CFR 405; 42 CFR 412; 42 CFR 422; 42 CFR 489 Legal Deadline: Final, Judicial, November 26, 2006, Based on language in settlement agreement. Abstract: This rule sets forth new requirements for hospital discharge notices under both original Medicare and the Medicare Advantage (MA) program. Notably, this rule requires hospitals to comply with a 2-step notice process when discharging hospital inpatients that is similar to the notice requirements applicable to home health agencies (HHAs), skilled nursing facilities (SNFs), and comprehensive outpatient rehabilitation facilities (CORFs). Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 04/05/06 71 FR 17052 NPRM Comment Period End 06/05/06 Final Action 04/00/09 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Eileen Zerhusen, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Medicare Enrollment & Appeals Group, Mailstop S3-23- 03, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786-7803 Email: eileen.zerhusen@cms.hhs.gov Related RIN: Merged with 0938-AK48, Merged with 0938-AL67 RIN: 0938-AO41 [[Page 73267]] _______________________________________________________________________ 1194. IDENTIFICATION OF BACKWARD COMPATIBLE VERSION OF ADOPTED STANDARD FOR E-PRESCRIBING AND THE MEDICARE PRESCRIPTION DRUG PROGRAM (VERSION 8.1) (CMS-0018-F) Priority: Other Significant Legal Authority: 42 USC 1395 CFR Citation: 42 CFR 423 Legal Deadline: None Abstract: This final rule identifies Version 8.1 of the National Council for Prescription Drug Programs (NCPDP) SCRIPT Standard as a backward compatible update of the adopted Version 5.0. This rule also permits the voluntary use of Version 8.1 of the NCPDP SCRIPT Standard for conducting certain e-prescribing transactions for the electronic prescription drug program under title I of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA). Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Interim Final Rule 06/23/06 71 FR 36020 Final Action 06/00/09 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Gladys C. Wheeler, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Office of Electronic Standards and Services, Mailstop S2-16-17, 7500 Security Boulevard, Baltimore, MD 21244-1850 Phone: 410 786-0273 Email: gladys.wheeler@cms.hhs.gov Related RIN: Related to 0938-AN49 RIN: 0938-AO42 _______________________________________________________________________ 1195. [bull] PROHIBITION OF MID-YEAR BENEFIT ENHANCEMENTS FOR MEDICARE ADVANTAGE ORGANIZATIONS OFFERING PLANS IN CALENDAR YEAR 2007 AND SUBSEQUENT CALENDAR YEARS (CMS-4121-F) Priority: Other Significant Legal Authority: 42 USC 1302, 1395hh CFR Citation: 42 CFR 422.2; 42 CFR 422.254 Legal Deadline: None Abstract: This rule implements new policy, beginning with contracts in calendar year 2007, to prohibit Medicare Advantage (MA) organizations from offering mid-year benefit enhancements (MYBEs). The policy is based on our experience during the first year of the new Medicare Advantage program and our belief that, in order to fully comply with the statute (MMA), we can no longer permit MYBEs as these threaten the integrity of the competitive bidding process established by the statute. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 09/01/06 71 FR 52014 Final Action 09/00/09 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: Federal Agency Contact: Christopher McClintick, Health Insurance Specialist, Center for Beneficiary Choices, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Medicare Advantage Group, Division of Plan Policy, 7500 Security Boulevard, Baltimore, MD 21244 Phone: 410 786-4682 Email: christopher.mcclintick@cms.hhs.gov RIN: 0938-AO54 _______________________________________________________________________ Department of Health and Human Services (HHS) Completed Actions Centers for Medicare & Medicaid Services (CMS) _______________________________________________________________________ 1196. REQUIREMENTS FOR PROVIDERS AND SUPPLIERS TO ESTABLISH AND MAINTAIN MEDICARE ENROLLMENT (CMS-6002-F2) Priority: Other Significant CFR Citation: 42 CFR 424 Completed: ________________________________________________________________________ Reason Date FR Cite ________________________________________________________________________ Final Rule 04/21/06 71 FR 20754 Correcting Amendment 06/30/06 71 FR 37504 Regulatory Flexibility Analysis Required: No Small Entities Affected: Businesses Government Levels Affected: None Agency Contact: Michael Collett Phone: 410 786-6121 RIN: 0938-AH73 _______________________________________________________________________ 1197. ORGAN PROCUREMENT ORGANIZATION CONDITIONS FOR COVERAGE AND RECERTIFICATION (CMS-3064-F) (COMPLETION OF A SECTION 610 REVIEW) Priority: Economically Significant. Major under 5 USC 801. Legal Authority: 42 USC 1302 et al CFR Citation: 42 CFR 413; 42 CFR 441; 42 CFR 486; 42 CFR 498 Legal Deadline: Final, Statutory, February 4, 2008, MMA sec 902. Abstract: This rule establishes conditions for coverage for organ procurement organizations (OPOs) to be certified by the Secretary to receive payment from Medicare and Medicaid for organ procurement costs, and to be designated by the Secretary for a specific geographic service area. The Organ Procurement Organization Certification Act of 2000 requires CMS to increase the certification cycle for OPOs from two years to four years and to promulgate new performance standards for OPOs. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Interim Final Rule 12/28/01 66 FR 67109 NPRM 02/04/05 70 FR 6086 Final Rule 05/31/06 71 FR 30982 Regulatory Flexibility Analysis Required: No Small Entities Affected: Businesses Government Levels Affected: None Agency Contact: Marcia Newton, Health Insurance Specialist, Office of Clinical Standards and Quality, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Clinical Standards Group , Division of Institutional Quality Standards, Mailstop S3-02-01, [[Page 73268]] 7500 Security Boulevard, Baltimore, MD 21244-1850 Phone: 410 786-5265 Email: marcia.newton@cms.hhs.gov RIN: 0938-AK81 _______________________________________________________________________ 1198. FIRE SAFETY REQUIREMENTS FOR CERTAIN HEALTH CARE FACILITIES; ALCOHOL-BASED HAND SANITIZER AMENDMENT (CMS-3145-F) Priority: Other Significant CFR Citation: 42 CFR 403; 42 CFR 416; 42 CFR 418; 42 CFR 460; 42 CFR 482 to 42 CFR 483; 42 CFR 485 Completed: ________________________________________________________________________ Reason Date FR Cite ________________________________________________________________________ Final Rule 09/22/06 71 FR 55341 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Danielle Shearer Phone: 410 786-6617 Email: danielle.shearer@cms.hhs.gov RIN: 0938-AN36 _______________________________________________________________________ 1199. 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. CFR Citation: 42 CFR 488.1 to 488.9 Completed: ________________________________________________________________________ Reason Date FR Cite ________________________________________________________________________ Withdrawn 08/15/06 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Amber L. Wolfe Phone: 410 786-6773 Email: amber.wolfe@cms.hhs.gov RIN: 0938-AN62 _______________________________________________________________________ 1200. PHYSICIANS' REFERRALS TO HEALTH CARE ENTITIES WITH WHICH THEY HAVE FINANCIAL RELATIONSHIPS; E-PRESCRIBING EXCEPTIONS (CMS-1303-F) Priority: Other Significant CFR Citation: 42 CFR 411.357 Completed: ________________________________________________________________________ Reason Date FR Cite ________________________________________________________________________ Final Action 08/08/06 71 FR 45140 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Linda P. Howard Phone: 410 786-5255 Email: linda.howard@cms.hhs.gov RIN: 0938-AN69 _______________________________________________________________________ 1201. HOME HEALTH PAYMENT SYSTEM RATE UPDATE FOR CY 2007 AND DEFICIT REDUCTION ACT OF 2005 CHANGES TO MEDICARE PAYMENT FOR OXYGEN EQUIPMENT AND CAPPED RENTAL DURABLE MEDICAL EQUIPMENT (CMS-1304-F) Priority: Economically Significant. Major under 5 USC 801. CFR Citation: 42 CFR 484 Completed: ________________________________________________________________________ Reason Date FR Cite ________________________________________________________________________ NPRM 08/03/06 71 FR 44081 Final Action 11/09/06 71 FR 65884 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: None Agency Contact: Randy Throndset Phone: 410 786-0131 Email: randy.throndset@cms.hhs.gov RIN: 0938-AN76 _______________________________________________________________________ 1202. INPATIENT PSYCHIATRIC FACILITY PROSPECTIVE PAYMENT SYSTEM--UPDATE FOR RY 2007 (CMS-1306-F) Priority: Economically Significant. Major under 5 USC 801. CFR Citation: 42 CFR 412 Completed: ________________________________________________________________________ Reason Date FR Cite ________________________________________________________________________ Final Rule 05/09/06 71 FR 27040 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: Local Agency Contact: Janet Samen Phone: 410 786-9161 Email: janet.samen@cms.hhs.gov RIN: 0938-AN82 _______________________________________________________________________ 1203. INNOVATIONS IN FEE-FOR-SERVICE PAYMENT SYSTEMS TO IMPROVE QUALITY AND OUTCOMES (CMS-1298-ANPR) Priority: Other Significant CFR Citation: None Completed: ________________________________________________________________________ Reason Date FR Cite ________________________________________________________________________ Withdrawn 07/02/06 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Gay W. Burton Phone: 410 786-4564 Email: gay.burton@cms.hhs.gov Teresa Clark Phone: 410 786-1079 Email: teresa.clark@cms.hhs.gov RIN: 0938-AN91 _______________________________________________________________________ 1204. HEALTH CARE INFRASTRUCTURE IMPROVEMENT PROGRAM; LOAN PROGRAM FOR QUALIFYING HOSPITALS ENGAGED IN CANCER-RELATED HEALTH CARE (CMS-1287-F) Priority: Economically Significant. Major under 5 USC 801. CFR Citation: 42 CFR 505 Completed: ________________________________________________________________________ Reason Date FR Cite ________________________________________________________________________ Withdrawn 07/10/06 Regulatory Flexibility Analysis Required: No Small Entities Affected: Businesses Government Levels Affected: None Agency Contact: Melinda Jones Phone: 410 786-7069 Email: melinda.jones@cms.hhs.gov Tzvi Hefter Phone: 410 786-4487 Email: tzvi.hefter@cms.hhs.gov Related RIN: Related to 0938-AN93, Merged with 0938-AO12 RIN: 0938-AO03 [[Page 73269]] _______________________________________________________________________ 1205. PROSPECTIVE PAYMENT SYSTEM FOR LONG-TERM CARE HOSPITALS RY 2007: ANNUAL PAYMENT RATE UPDATES (CMS-1485-F) Priority: Economically Significant. Major under 5 USC 801. CFR Citation: 42 CFR 412 Completed: ________________________________________________________________________ Reason Date FR Cite ________________________________________________________________________ Final Rule 05/12/06 71 FR 27798 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: None Agency Contact: Linda McKenna Phone: 410 786-4537 Email: linda.mckenna@cms.hhs.gov RIN: 0938-AO06 _______________________________________________________________________ 1206. QUALITY STANDARDS FOR GENETIC TESTING (CMS-2121-P) Priority: Other Significant CFR Citation: None Completed: ________________________________________________________________________ Reason Date FR Cite ________________________________________________________________________ Withdrawn 08/15/06 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Penelope Mattingly Phone: 410 786-3366 Email: penelope.mattingly@cms.hhs.gov RIN: 0938-AO09 _______________________________________________________________________ 1207. REVISIONS TO THE PAYMENT POLICIES OF AMBULANCE SERVICES UNDER THE FEE SCHEDULE FOR AMBULANCE SERVICES (CMS-1317-F) Priority: Other Significant. Major under 5 USC 801. CFR Citation: 42 CFR 414.605; 42 CFR 412.64; 42 CFR 410.40; 42 CFR 410.12; 42 CFR 414.610; 42 CFR 414.615 Completed: ________________________________________________________________________ Reason Date FR Cite ________________________________________________________________________ NPRM 05/26/06 71 FR 30358 Withdrawn 09/12/06 Regulatory Flexibility Analysis Required: No Small Entities Affected: Businesses Government Levels Affected: None Agency Contact: Anne Elizabeth Tayloe Phone: 410 786-4546 Email: anne.tayloe@cms.hhs.gov Related RIN: Related to 0938-AO39, Merged with 0938-AO24 RIN: 0938-AO11 _______________________________________________________________________ 1208. HOSPITAL INPATIENT PROSPECTIVE PAYMENT SYSTEMS AND FISCAL YEAR 2007 RATES: FINAL FISCAL YEAR 2007 WAGE INDICES AND PAYMENT RATES AFTER APPLICATION OF REVISED OCCUPATIONAL MIX ADJUSTMENT (CMS-1488-N) Priority: Other Significant CFR Citation: 42 CFR 412 Completed: ________________________________________________________________________ Reason Date FR Cite ________________________________________________________________________ NPRM 04/25/06 71 FR 23995 Second NPRM 05/17/06 71 FR 28644 Final Action 08/18/06 71 FR 47870 Correction Notice 10/03/06 71 FR 58286 Notice 10/11/06 71 FR 59886 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: Federal Agency Contact: Tzvi Hefter Phone: 410 786-4487 Email: tzvi.hefter@cms.hhs.gov Related RIN: Related to 0938-AN93, Related to 0938-AO03, Related to 0938-AN58 RIN: 0938-AO12 _______________________________________________________________________ 1209. CHANGES TO THE HOSPITAL OUTPATIENT PROSPECTIVE PAYMENT SYSTEM AND CY 2007 PAYMENT RATES; AND CHANGES TO THE ASC PAYMENT SYSTEM IN CY 2007 (CMS-1506-F) Priority: Economically Significant. Major under 5 USC 801. CFR Citation: 42 CFR 419 to 485 Completed: ________________________________________________________________________ Reason Date FR Cite ________________________________________________________________________ NPRM 08/23/06 71 FR 49506 Final Action 11/24/06 71 FR 67960 Final Action Effective 01/01/07 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: Federal Federalism: This action may have federalism implications as defined in EO 13132. Agency Contact: James Hart Phone: 410 786-9520 Email: james.hart@cms.hhs.gov Related RIN: Related to 0938-AO13, Related to 0938-AN23 RIN: 0938-AO15 _______________________________________________________________________ 1210. PROSPECTIVE PAYMENT SYSTEM FOR INPATIENT REHABILITATION FACILITIES FOR FY 2007, CERTAIN PROVISIONS CONCERNING COMPETITIVE ACQUISITION FOR DMEPOS (CMS-1540-F) Priority: Economically Significant. Major under 5 USC 801. CFR Citation: 42 CFR 412.23, 412.624, 414.1; 414.406, 424.1, 424.57; 424.58 Completed: ________________________________________________________________________ Reason Date FR Cite ________________________________________________________________________ NPRM 05/15/06 71 FR 28106 Final Rule 08/18/06 71 FR 48354 Correction Notice 09/29/06 71 FR 57447 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: None Agency Contact: Bill Ullman Phone: 410 786-5667 Email: bill.ullman@cms.hhs.gov RIN: 0938-AO16 _______________________________________________________________________ 1211. 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: Economically Significant. Major under 5 USC 801. CFR Citation: None Completed: ________________________________________________________________________ Reason Date FR Cite ________________________________________________________________________ Notice 09/18/06 71 FR 54661 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Clare McFarland Phone: 410 786-6390 [[Page 73270]] Email: clare.mcfarland@cms.hhs.gov RIN: 0938-AO18 _______________________________________________________________________ 1212. INPATIENT HOSPITAL DEDUCTIBLE AND HOSPITAL AND EXTENDED CARE SERVICES COINSURANCE AMOUNTS FOR CALENDAR YEAR 2007 (CMS-8029-N) Priority: Economically Significant. Major under 5 USC 801. CFR Citation: None Completed: ________________________________________________________________________ Reason Date FR Cite ________________________________________________________________________ Notice 09/18/06 71 FR 54662 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Clare McFarland Phone: 410 786-6390 Email: clare.mcfarland@cms.hhs.gov RIN: 0938-AO19 _______________________________________________________________________ 1213. FISCAL YEAR 2007 SCHIP ALLOTMENTS (CMS-2251-N) Priority: Other Significant CFR Citation: 42 CFR 457 Completed: ________________________________________________________________________ Reason Date FR Cite ________________________________________________________________________ Notice 07/28/06 71 FR 42854 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-AO21 _______________________________________________________________________ 1214. FIVE-YEAR REVIEW OF WORK RELATIVE VALUE UNITS UNDER THE PHYSICIAN FEE SCHEDULE (CMS-1512-PN) Priority: Economically Significant. Major under 5 USC 801. CFR Citation: None Completed: ________________________________________________________________________ Reason Date FR Cite ________________________________________________________________________ NPRM 06/29/06 71 FR 37170 Withdrawn 09/07/06 Regulatory Flexibility Analysis Required: No Small Entities Affected: Businesses Government Levels Affected: None Agency Contact: Diane Milstead Phone: 410 786-3355 Email: diane.milstead@cms.hhs.gov Related RIN: Merged with 0938-AO24 RIN: 0938-AO22 _______________________________________________________________________ 1215. PART B MONTHLY ACTUARIAL RATES AND PREMIUM RATES BEGINNING JANUARY 1, 2007 (CMS-8030-N) Priority: Economically Significant. Major under 5 USC 801. CFR Citation: None Completed: ________________________________________________________________________ Reason Date FR Cite ________________________________________________________________________ Notice 09/18/06 71 FR 54665 Correction Notice 09/22/06 71 FR 55480 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Suzanne Codespote Phone: 410 786-7737 Email: suzanne.codespote@cms.hhs.gov RIN: 0938-AO23 _______________________________________________________________________ 1216. REVISIONS TO PAYMENT POLICIES UNDER THE PHYSICIAN FEE SCHEDULE AND AMBULANCE FEE SCHEDULE FOR CALENDAR YEAR 2007 (CMS-1321-FC) Priority: Economically Significant. Major under 5 USC 801. CFR Citation: 42 CFR 405; 42 CFR 410 to 411; 42 CFR 413 to 414; 42 CFR 426 Completed: ________________________________________________________________________ Reason Date FR Cite ________________________________________________________________________ NPRM 08/22/06 71 FR 48982 Final Action 12/01/06 71 FR 69624 Final Action Effective 01/01/07 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses, Organizations Government Levels Affected: Undetermined Agency Contact: Diane Milstead Phone: 410 786-3355 Email: diane.milstead@cms.hhs.gov Related RIN: Related to 0938-AN26, Related to 0938-AN05, Related to 0938-AO22, Related to 0938-AO11 RIN: 0938-AO24 _______________________________________________________________________ 1217. 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. CFR Citation: 42 CFR 424 Completed: ________________________________________________________________________ Reason Date FR Cite ________________________________________________________________________ Notice 07/31/06 71 FR 43158 Correction Notice 09/29/06 71 FR 57519 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses, Organizations Government Levels Affected: None Agency Contact: Bill Ullman Phone: 410 786-5667 Email: bill.ullman@cms.hhs.gov RIN: 0938-AO25 _______________________________________________________________________ 1218. HOSPICE WAGE INDEX FOR FY 2007 (CMS-1535-N) Priority: Other Significant CFR Citation: 42 CFR 418 Completed: ________________________________________________________________________ Reason Date FR Cite ________________________________________________________________________ Final Action 09/01/06 71 FR 52080 Correction Notice 10/03/06 71 FR 58415 Regulatory Flexibility Analysis Required: No Small Entities Affected: Businesses Government Levels Affected: None Agency Contact: Terri Deutsch Phone: 410 786-9462 Email: terri.deutsch@cms.hhs.gov RIN: 0938-AO26 _______________________________________________________________________ 1219. STATE ALLOTMENTS FOR PAYMENT OF MEDICARE PART B PREMIUMS FOR QUALIFYING INDIVIDUALS: FISCAL YEAR 2006 (CMS-2231-F) Priority: Other Significant CFR Citation: 42 CFR 433.10 [[Page 73271]] Completed: ________________________________________________________________________ Reason Date FR Cite ________________________________________________________________________ Interim Final Rule 04/28/06 71 FR 25085 Final Action 10/16/06 71 FR 60663 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Governmental Jurisdictions Government Levels Affected: State Agency Contact: Richard Strauss Phone: 410 786-2019 Email: richard.strauss@cms.hhs.gov Related RIN: Related to 0938-AO04 RIN: 0938-AO31 _______________________________________________________________________ 1220. PROVIDER NOMINATION PROVISION (CMS-1331-P) Priority: Substantive, Nonsignificant CFR Citation: 42 CFR 421.103 to 42 CFR 421.106 ; 42 CFR 421.114 Completed: ________________________________________________________________________ Reason Date FR Cite ________________________________________________________________________ Withdrawn 06/07/07 Regulatory Flexibility Analysis Required: No Small Entities Affected: Businesses Government Levels Affected: Local Agency Contact: Scott Sturiale Phone: 410 786-2565 Email: scott.sturiale@cms.hhs.gov Related RIN: Merged with 0938-AO15 RIN: 0938-AO33 _______________________________________________________________________ 1221. EXTENDING SUNSET DATE FOR THE INTERIM FINAL REGULATION ON MENTAL HEALTH PARITY (CMS-4094-F4) Priority: Other Significant CFR Citation: 45 CFR 146 Completed: ________________________________________________________________________ Reason Date FR Cite ________________________________________________________________________ Final Rule 04/28/06 71 FR 25092 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: Local, State Agency Contact: Adam Shaw Phone: 410 786-1091 Email: adam.shaw@cms.hhs.gov Karen Levin Phone: 410 786-5445 Email: karen.levin@cms.hhs.gov Related RIN: Related to 0938-AN80 RIN: 0938-AO36 _______________________________________________________________________ 1222. STATE HEALTH INSURANCE ASSISTANCE PROGRAM (SHIP) (CMS-4005-F) Priority: Other Significant CFR Citation: 42 CFR 403 Completed: ________________________________________________________________________ Reason Date FR Cite ________________________________________________________________________ Final Rule 05/26/06 71 FR 30289 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: Local, State Agency Contact: Eric Lang Phone: 410 786-3199 Email: eric.lang@cms.hhs.gov Related RIN: Related to 0938-AJ67 RIN: 0938-AO37 _______________________________________________________________________ 1223. STATE CHILDREN'S HEALTH INSURANCE PROGRAM (SCHIP) REDISTRIBUTION OF UNEXPENDED SCHIP FUNDS FROM THE APPROPRIATION FOR FISCAL YEAR 2003 (CMS-2235-NC) Priority: Other Significant CFR Citation: 42 CFR 457.600.630 Completed: ________________________________________________________________________ Reason Date FR Cite ________________________________________________________________________ Notice 04/21/06 71 FR 20697 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-AO38 _______________________________________________________________________ 1224. FEE SCHEDULE FOR PAYMENT OF AMBULANCE SERVICES--UPDATE FOR CY 2007 (CMS-1532-N) Priority: Economically Significant. Major under 5 USC 801. CFR Citation: 42 CFR 410 Completed: ________________________________________________________________________ Reason Date FR Cite ________________________________________________________________________ Withdrawn 07/27/06 Regulatory Flexibility Analysis Required: No Small Entities Affected: Businesses Government Levels Affected: None Agency Contact: Anne Tayloe Phone: 410 786-4546 Email: ann.tayloe@cms.hhs.gov Related RIN: Merged with 0938-AO11 RIN: 0938-AO39 _______________________________________________________________________ 1225. [bull] FISCAL YEAR DISPROPORTIONATE SHARE HOSPITAL ALLOTMENTS AND DISPROPORTIONATE SHARE HOSPITAL INSTITUTIONS FOR MENTAL DISEASE LIMITS (CMS-2243-N) Priority: Other Significant Legal Authority: Title XIX of the Social Security Act, secs 1923(f) and (h); sec 6054 of the Deficit Reduction Act of 2005, PL 109-171 CFR Citation: None Legal Deadline: Final, Statutory, September 30, 2006, Determination of fiscal year DSH allotment and IMD DSH Limits. Abstract: This notice sets forth the States' final fiscal year (FY) 2005, preliminary FY 2006, and preliminary FY 2007 disproportionate share hospital (DSH) payment allotments and States' institutions for mental disease (IMD) DSH limits in the Medicaid program. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Notice 10/03/06 71 FR 58398 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: State Agency Contact: Richard Strauss, Senior Financial Advisor, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Centers for Medicaid State Operations, Mailstop S3-13-15, 7500 Security Boulevard, Baltimore, MD 21244-1850 Phone: 410 786-2019 Fax: 410-786-0025 Email: richard.strauss@cms.hhs.gov RIN: 0938-AO75 [[Page 73272]] _______________________________________________________________________ Department of Health and Human Services (HHS) Proposed Rule Stage Administration for Children and Families (ACF) _______________________________________________________________________ 1226. 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 12/00/06 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, 370 L'Enfant Promenade SW., Washington, DC 20447 Phone: 202 690-5841 RIN: 0970-AC07 _______________________________________________________________________ 1227. 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 12/00/06 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 _______________________________________________________________________ 1228. MEDICAL SUPPORT Priority: Other Significant Legal Authority: 42 USC 1302 CFR Citation: 45 CFR 302 to 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 12/00/06 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.hhs.gov RIN: 0970-AC22 _______________________________________________________________________ 1229. 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 (Pub. L. 108-145). Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 12/00/06 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: State Agency Contact: Kathleen McHugh, Director, Division of Policy, Children's Bureau, ACYF/ACF/HHS, Department of Health and Human Services, Administration for Children and Families, 370 L'Enfant Promenade SW., Washington, DC 20447 Phone: 202 401-5789 Fax: 202 205-8221 Email: kmchugh@acf.hhs.gov RIN: 0970-AC23 _______________________________________________________________________ 1230. CHILD SUPPORT PROVISIONS OF THE DEFICIT REDUCTION ACT Priority: Substantive, Nonsignificant Legal Authority: 42 USC 1302 CFR Citation: Not Yet Determined Legal Deadline: None Abstract: The proposed rule would implement provisions of the Deficit Reduction Act of 2005 related to review and adjustment of child support orders, Federal financial participation in the program, and fees for program services. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 12/00/06 Regulatory Flexibility Analysis Required: No Small Entities Affected: Governmental Jurisdictions Government Levels Affected: Federal, 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 [[Page 73273]] Email: bmatheson@acf.hhs.gov RIN: 0970-AC24 _______________________________________________________________________ 1231. PRIVATIZING FUNCTIONS Priority: Substantive, Nonsignificant Legal Authority: 42 USC 1302 CFR Citation: 45 CFR 1355 to 1356 Legal Deadline: None Abstract: Proposed rule would address States' ability to delegate decision-making authority to private agencies performing administration functions and the availability of funding for training funds under the Foster Care program. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 03/00/07 Regulatory Flexibility Analysis Required: No Small Entities Affected: Businesses, Governmental Jurisdictions Government Levels Affected: State Agency Contact: Kathleen McHugh, Director, Division of Policy, Children's Bureau, ACYF/ACF/HHS, Department of Health and Human Services, Administration for Children and Families, 370 L'Enfant Promenade SW., Washington, DC 20447 Phone: 202 401-5789 Fax: 202 205-8221 Email: kmchugh@acf.hhs.gov RIN: 0970-AC25 _______________________________________________________________________ 1232. [bull] LIMITATION ON USE OF FUNDS MADE AVAILABLE TO MONITOR AND COMBAT TRAFFICKING IN PERSONS Priority: Other Significant Legal Authority: 22 USC chapter 78 Trafficking Victims Protection Act CFR Citation: 45 CFR 404 Legal Deadline: None Abstract: This rule will implement provisions of the Trafficking Victims Protection Act which prohibit programs from using trafficking funds to promote, support, or advocate the legalization or practice of prostitution and make organizations ineligible to receive such funds that promotes, supports, or advocates the legalization or the practice of prostitution if the program operates a program that targets several forms of trafficking unless the organization provides services to individuals solely after they are no longer engaged in activities that resulted from such activities being trafficked. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 01/00/07 Regulatory Flexibility Analysis Required: No Small Entities Affected: Businesses Government Levels Affected: None Agency Contact: Kenneth Tota, Chief of Operations - Office of Refugee Resettlement, Department of Health and Human Services, Administration for Children and Families, 370 L'Enfant Promenade SW., Washington, DC 20447 Phone: 202 401-4858 Email: ktota@acf.hhs.gov RIN: 0970-AC28 _______________________________________________________________________ 1233. [bull] CHILD CARE AND DEVELOPMENT FUND ERROR RATE Priority: Other Significant Legal Authority: Improper Payments Information Act (PL 107-300) CFR Citation: 45 CFR 98 Legal Deadline: None Abstract: This rule will require States and selected Territories to employ a case review process every four years in calculating a CCDF error rate. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 01/00/07 Regulatory Flexibility Analysis Required: No Small Entities Affected: Governmental Jurisdictions Government Levels Affected: Local, State, Tribal Agency Contact: Jeffrey J. Polich, Child Care Program Specialist, Department of Health and Human Services, Administration for Children and Families, 1250 Maryland Avenue SW., 8th Floor, Washington, DC 20447 Phone: 202 205-8696 Email: jeffrey.polich@acf.hhs.gov RIN: 0970-AC29 _______________________________________________________________________ 1234. [bull] ABSTINENCE EDUCATION Priority: Other Significant Unfunded Mandates: This action may affect State, local or tribal governments and the private sector. Legal Authority: sec 510 of the Social Security Act CFR Citation: 45 CFR 1352 Legal Deadline: None Abstract: This rule will provide guidance on the general requirements for abstinence education curricula; clarify the treatment of section 510(b)(2)(A) through (H). Clarify appropriate target age groups for title V State Abstinence Education Grants; and, clarify appropriate application of additional activities used by title V State Abstinence Education grantees. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 01/00/07 Regulatory Flexibility Analysis Required: No Small Entities Affected: Organizations Government Levels Affected: State Federalism: This action may have federalism implications as defined in EO 13132. Agency Contact: Jeffrey S. Trimbath, Director, Abstinence Education Division, Family and Youth Services Bureau, Department of Health and Human Services, Administration for Children and Families, 1250 Maryland Avenue SW., 8th Floor, Washington, DC 20447 Phone: 202 401-9205 Email: jeffrey.trimbath@acf.hhs.gov RIN: 0970-AC30 [[Page 73274]] _______________________________________________________________________ Department of Health and Human Services (HHS) Final Rule Stage Administration for Children and Families (ACF) _______________________________________________________________________ 1235. 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 10/14/05 70 FR 60038 NPRM Comment Period End 12/13/05 Final Action 05/00/07 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.hhs.gov RIN: 0970-AC01 _______________________________________________________________________ 1236. COST ALLOCATION METHODOLOGY APPLICABLE TO THE TEMPORARY ASSISTANCE FOR NEEDY FAMILIES PROGRAM Priority: Other Significant 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, the Medicaid program, and the Food Stamp programs. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 09/27/06 71 FR 56440 NPRM Comment Period End 11/27/06 Final Action 09/00/07 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: Local, State Agency Contact: Grant Collins, Deputy Director, Office of Family Assistance, Department of Health and Human Services, Administration for Children and Families, 5th Floor East, 370 L'Enfant Promenade SW., Washington, DC 20447 Phone: 202 401-6953 Email: gcollins@acf.hhs.gov RIN: 0970-AC15 _______________________________________________________________________ 1237. 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 05/00/07 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: Local, State Agency Contact: Shannon Christian, Associate Director, Child Care - Office of Family Assistance, Department of Health and Human Services, Administration for Children and Families, 1250 Maryland Avenue SW., 8th Floor, Washington, DC 20447 Phone: 202 260-2390 Email: schristian@acf.hhs.gov RIN: 0970-AC18 _______________________________________________________________________ 1238. 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 07/14/06 71 FR 40345 Final Action 07/00/07 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: State Agency Contact: Kathleen McHugh, Director, Division of Policy, Children's Bureau, ACYF/ACF/HHS, Department of Health and Human Services, Administration for Children and Families, 370 L'Enfant Promenade SW., Washington, DC 20447 Phone: 202 401-5789 Fax: 202 205-8221 Email: kmchugh@acf.hhs.gov RIN: 0970-AC21 _______________________________________________________________________ 1239. HEAD START TRANSPORTATION Priority: Other Significant Legal Authority: 42 USC 9801 et seq [[Page 73275]] CFR Citation: 45 CFR 1310 Legal Deadline: None Abstract: This proposed rule will address waiver for Head Start grantees from certain transportation requirements related to child safety restraint systems and bus monitors. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 05/30/06 71 FR 30645 Final Action 12/00/06 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Craig Turner, Department of Health and Human Services, Administration for Children and Families, P.O. Box 1182, Washington, DC 20013 Phone: 202 205-8236 Email: cturner@acf.hhs.gov RIN: 0970-AC26 _______________________________________________________________________ 1240. TANF WORK PROVISIONS OF THE DEFICIT REDUCTION ACT Priority: Other Significant Legal Authority: 42 USC 1302 CFR Citation: 261, et al Legal Deadline: Other, Statutory, June 30, 2006, Interim Final Rule. Abstract: This rule will address new work requirements associated with the Deficit Reduction Act of 2005, including what counts as work activities, reporting and verifying hours of work and who should be included in the work participation rate. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Interim Final Rule 06/29/06 71 FR 37454 Final Action 04/00/07 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: State, Tribal Agency Contact: Robert Shelbourne, Director of Policy, OFA/ACF/HHS, Department of Health and Human Services, Administration for Children and Families, 901 D Street SW., Washington, DC 20447 Phone: 202 401-5150 Email: rshelbourne@acf.hhs.gov RIN: 0970-AC27 _______________________________________________________________________ Department of Health and Human Services (HHS) Completed Actions Administration for Children and Families (ACF) _______________________________________________________________________ 1241. REASONABLE QUANTITATIVE STANDARD FOR REVIEW AND ADJUSTMENT OF CHILD SUPPORT ORDERS Priority: Other Significant CFR Citation: 45 CFR 303 Completed: ________________________________________________________________________ Reason Date FR Cite ________________________________________________________________________ Final Action 05/23/06 71 FR 29590 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: Local, State Agency Contact: Elizabeth C. Matheson Phone: 202 401-9386 Email: bmatheson@acf.hhs.gov RIN: 0970-AC19 [FR Doc. 06-8151 Filed 12-08-06; 8:45 am] BILLING CODE 4150-24-S