[The Regulatory Plan and Unified Agenda of Federal Regulatory and Deregulatory Actions] [Department of Health and Human Services Semiannual Regulatory Agenda] [From the U.S. Government Printing Office, www.gpo.gov] ----------------------------------------------------------------------- Part VIII Department of Health and Human Services ----------------------------------------------------------------------- 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: [email protected] 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: [email protected] 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: [email protected] 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: [email protected] 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: [email protected] 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: [email protected] 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: [email protected] 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: [email protected] 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: [email protected] 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: [email protected] 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: [email protected] 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: [email protected] 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: [email protected] 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: [email protected] 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: [email protected] 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: [email protected] 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: [email protected] 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: [email protected] 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: [email protected] 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: [email protected] 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: [email protected] 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: [email protected] 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: [email protected] 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: [email protected] 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: [email protected] 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: [email protected] 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: [email protected] 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: [email protected] 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: [email protected] 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: [email protected] 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: [email protected] 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: [email protected] 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: [email protected] 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: [email protected] 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: [email protected] 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: [email protected] 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: [email protected] 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: [email protected] 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: [email protected] 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: [email protected] 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: [email protected] 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: [email protected] 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: [email protected] 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: [email protected] 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: [email protected] 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: [email protected] 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: [email protected] 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: [email protected] 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: [email protected] 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: [email protected] 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: [email protected] 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: [email protected] 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: [email protected] 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: [email protected] 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: [email protected] 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: [email protected] 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: [email protected] 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: [email protected] 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: [email protected] 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: [email protected] 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: [email protected] 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: [email protected] 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: [email protected] 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: [email protected] 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: [email protected] 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: [email protected] 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: [email protected] 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: