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The Unified Agenda of Federal Regulatory and Deregulatory Actions, (also know as the semi-annual regulatory agenda) is published in the spring and fall of each year. Since 1978, Federal agencies have been required by Executive orders to publish agendas of regulatory and deregulatory activities. The Regulatory Plan, which is published as part of the fall edition of the Agenda, identifies regulatory priorities and contains additional detail about the most important significant regulatory actions that agencies expect to take in the coming year.
Following is the portion of the Fall 2001 Unified Agenda for the Food and Drug Administration.
| Food and Drug Administration—Prerule Stage | Sequence Number | Title | Regulation Identification Number |
|---|---|---|
| 1008 | Natural Rubber-Containing Drugs; User Labeling | 0910-AB56 |
| 1009 | Requirements for Submission of In Vivo Bioequivalence Data | 0910-AC23 |
| 1010 | Requirements for Medical Gas Containers and Closure Systems | 0910-AC24 |
References in boldface appear in the Regulatory Plan in part II of this issue of the Federal Register
| Food and Drug Administration—Proposed Rule Stage | Sequence Number | Title | Regulation Identification Number |
|---|---|---|
| 1011 | Over-the-Counter (OTC) Drug Review | 0910-AA01 |
| 1012 | Establishment Registration and Product Listing for Drugs and Biologics | 0910-AA49 |
| 1013 | Investigational New Drugs: Export Requirements for Unapproved New Drug Products | 0910-AA61 |
| 1014 | Safety Reporting and Recordkeeping Requirements for Marketed OTC Drugs | 0910-AA86 |
| 1015 | Safety Reporting Requirements for Human Drug and Biological Products (Reg Plan Seq No. 28) | 0910-AA97 |
| 1016 | Radioactive Drugs for Basic Research | 0910-AB00 |
| 1017 | Administrative Practices and Procedures; Advisory Opinions and Guidelines | 0910-AB14 |
| 1018 | Blood Initiative | 0910-AB26 |
| 1019 | Applications for FDA Approval to Market a New Drug; Complete Response Letter; Amendments to Unapproved Applications | 0910-AB34 |
| 1020 | Expanded Access to Investigational Therapies | 0910-AB37 |
| 1021 | Electronic Submission of Postmarketing Safety Reports | 0910-AB42 |
| 1022 | Distinguishing Marks for Drug Products Containing Insulin | 0910-AB43 |
| 1023 | Pregnancy Labeling | 0910-AB44 |
| 1024 | Positron Emission Tomography Drugs; Current Good Manufacturing Practice | 0910-AB63 |
| 1025 | Current Good Manufacturing Practice for Medicated Feeds | 0910-AB70 |
| 1026 | Fixed-Combination Prescription and Over-the-Counter Drugs for Human Use | 0910-AB79 |
| 1027 | Repackaging Approval Requirements | 0910-AB81 |
| 1028 | Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Dietary Ingredients and Dietary Supplements (Reg Plan Seq No. 29) | 0910-AB88 |
| 1029 | Submission in Electronic Format of Certain Labeling Information | 0910-AB91 |
| 1030 | Fees Relating to Drugs; Waiver and Reduction of Fees | 0910-AB92 |
| 1031 | Periodic Testing for Certain Human Drug, Veterinary Drug, and Biological Product Final Specifications | 0910-AB93 |
| 1032 | Requirements Pertaining to Sampling Services and Private Laboratories Used in Connection with Imported Food | 0910-AB96 |
| 1033 | Medical Devices, Medical Device Establishment Registration and Listing Requirements; Amendment | 0910-AB99 |
| 1034 | Reporting Information Regarding Falsification of Data | 0910-AC02 |
| 1035 | Status Reports of Distribution and Use Information for Antimicrobial Animal Drug Products Used in Food-Producing Animals | 0910-AC04 |
| 1036 | Labeling Dietary Supplements for Women Who Are or May Become Pregnant | 0910-AC09 |
| 1037 | Regulation of Carcinogenic Compounds Used in Food-Producing Animals; Definition of "No Residue" | 0910-AC13 |
| 1038 | Control of Salmonella Enteritidis in Shell Eggs During Production and Retail (Reg Plan Seq No. 30) | 0910-AC14 |
| 1039 | Aluminum in Large and Small Volume Parenterals Used in Total Parenteral Nutrition | 0910-AC18 |
| 1040 | Use of Materials Derived from Ruminant Animals in FDA Regulated Products | 0910-AC19 |
| 1041 | Postmarketing Reports of Substandard or Ineffective Bulk Ingredients and Bulk Ingredients from Unapproved Sources | 0910-AC20 |
| 1042 | Exception from General Requirements for Informed Consent; Request for Comments and Information (Reg Plan Seq No. 31) | 0910-AC25 |
| 1043 | Bar Code Label Requirements for Human Drug Products (Reg Plan Seq No. 32) | 0910-AC26 |
| 1044 | Promotion and Charging For Investigational Drugs | 0910-AC27 |
References in boldface appear in the Regulatory Plan in part II of this issue of the Federal Register
| Food and Drug Administration—Final Rule Stage | Sequence Number | Title | Regulation Identification Number |
|---|---|---|
| 1045 | New Animal Drug Approval Process; Implementation of Title I of the Generic Animal Drug and Patent Term Restoration Act (GADPTRA) | 0910-AA02 |
| 1046 | Current Good Manufacturing Practice; Amendment of Certain Requirements for Finished Pharmaceuticals | 0910-AA45 |
| 1047 | Bioavailability and Bioequivalence Requirements | 0910-AA51 |
| 1048 | Determination That Informed Consent Is Infeasible or Is Contrary to the Best Interest of Recipients | 0910-AA89 |
| 1049 | Labeling for Human Prescription Drugs; Revised Format (Reg Plan Seq No. 33) | 0910-AA94 |
| 1050 | Current Good Manufacturing Practice; Revision of Certain Labeling Controls | 0910-AA98 |
| 1051 | Use of Ozone-Depleting Substances | 0910-AA99 |
| 1052 | Exports; Notification and Recordkeeping Requirements | 0910-AB16 |
| 1053 | Foreign Establishment Registration and Listing (Reg Plan Seq No. 34) | 0910-AB21 |
| 1054 | FDA Export Reform and Enhancement Act of 1996; Reporting and Recordkeeping Requirements for Unapproved or Violative Products Imported for Further Processing or Incorporation and Later Export | 0910-AB24 |
| 1055 | Antibiotic Drug Approval and Exclusivity | 0910-AB33 |
| 1056 | Amendment of Regulations Regarding Certain Label Statements on Prescription Drugs | 0910-AB39 |
| 1057 | Supplements and Other Changes to Approved New Animal Drug Applications | 0910-AB49 |
| 1058 | Revisions to the General Safety Requirements for Biological Products; Direct Final Rule | 0910-AB51 |
| 1059 | Discontinuation of a Lifesaving Product | 0910-AB60 |
| 1060 | Supplements and Other Changes to an Approved Application | 0910-AB61 |
| 1061 | Food Labeling: Trans Fatty Acids in Nutrition Labeling, Nutrient Content Claims, and Health Claims (Reg Plan Seq No. 35) | 0910-AB66 |
| 1062 | Presubmission Conferences | 0910-AB68 |
| 1063 | Surgeon's and Patient Examination Gloves; Reclassification | 0910-AB74 |
| 1064 | CGMPs for Blood and Blood Components: Notification of Consignees and Transfusion Recipients Receiving Blood and Blood Components at Increased Risk of Transmitting HCV (Lookback) (Reg Plan Seq No. 36) | 0910-AB76 |
| 1065 | Antibiotic Resistance Labeling | 0910-AB78 |
| 1066 | 180-Day Generic Drug Exclusivity for Abbreviated New Drug Applications | 0910-AB80 |
| 1067 | Food Additives: Food Contact Substances Notification System | 0910-AB94 |
| 1068 | Marking Requirements for and Prohibitions on the Reimportation of Imported Food Products That Have Been Refused Admission into the United States (Reg Plan Seq No. 37) | 0910-AB95 |
| 1069 | State Certification of Mammography Facilities | 0910-AB98 |
| 1070 | Availability for Public Disclosure and Submission to FDA for Public Disclosure of Certain Data and Information Related to Gene Therapy or Xenotransplantation | 0910-AC00 |
| 1071 | Examination of Administrative Record and Other Advisory Committee Records | 0910-AC03 |
| 1072 | Efficacy Evidence Needed for Products to be Used Against Toxic Substances When Human Studies Are Unethical (Reg Plan Seq No. 38) | 0910-AC05 |
| 1073 | Additional Safeguards for Children in Clinical Investigations of FDA Regulated Products | 0910-AC07 |
| 1074 | Implementing Court Decisions, ANDA Approvals, and 180-Day Exclusivity | 0910-AC11 |
| 1075 | Revocation of Conditions for Marketing Digoxin Products for Oral Use | 0910-AC12 |
| 1076 | Additional Criteria and Procedures for Classifying Over-the-Counter Drugs as Generally Recognized as Safe and Effective and Not Misbranded (Reg Plan Seq No. 39) | 0910-AC22 |
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 | Sequence Number | Title | Regulation Identification Number |
|---|---|---|
| 1077 | Infant Formula: Requirements Pertaining to Good Manufacturing Practice, Quality Control Procedures, Quality Factors, Notification Requirements, and Records and Reports | 0910-AA04 |
| 1078 | Food Labeling Review | 0910-AA19 |
| 1079 | Medical Foods | 0910-AA20 |
| 1080 | Direct-to-Consumer Promotion Regulations | 0910-AA90 |
| 1081 | Investigational Use New Animal Drug Regulations (Section 610 Review) | 0910-AB02 |
| 1082 | Suitability Determination for Donors of Human Cellular and Tissue-Based Products | 0910-AB27 |
| 1083 | Current Good Tissue Practice for Manufacturers of Human Cellular and Tissue-Based Products | 0910-AB28 |
| 1084 | Requirements for Liquid Medicated Feed and Free-Choice Medicated Feed | 0910-AB50 |
| 1085 | Bulk Drug Substances for Use in Pharmacy Compounding | 0910-AB57 |
| 1086 | Pharmacy and Physician Compounding of Drug Products | 0910-AB58 |
| 1087 | Drug Products That Present Demonstrable Difficulties for Compounding Because of Reasons of Safety or Effectiveness | 0910-AB59 |
| 1088 | Implementation of the Import Tolerance Provisions of the Animal Drug Availability Act of 1996 | 0910-AB71 |
| 1089 | Mandatory HACCP Regulations for Manufacturers of Rendered Products | 0910-AB72 |
| 1090 | Citizen Petitions; Actions That Can Be Requested by Petition; Denials, Withdrawals, and Referrals for Other Administrative Action | 0910-AB73 |
| 1091 | Stability Testing of Drugs | 0910-AB82 |
| 1092 | Substances Prohibited From Use in Animal Food or Feed | 0910-AB90 |
| 1093 | Addition to the List of Drug Products That Have Been Withdrawn From the Market for Reasons of Safety or Effectiveness | 0910-AC01 |
| 1094 | Addition to the List of Drug Products That Have Been Withdrawn or Removed From the Market for Reasons of Safety or Effectiveness | 0910-AC08 |
| 1095 | Overwrap for Inhalation Products Packaged in Low Density Polyethylene (LDPE) Containers | 0910-AC10 |
| 1096 | Premarket Notice Concerning Bioengineered Foods | 0910-AC15 |
| 1097 | Rescission of Substantially Equivalent Decisions and Rescission Appeal Procedures | 0910-AC16 |
| 1098 | Institutional Review Boards: Registration Requirements | 0910-AC17 |
| 1099 | Chronic Wasting Disease: Control of Food Products and Cosmetics Derived from Exposed Animal Populations | 0910-AC21 |
| Food and Drug Administration—Completed Actions | Sequence Number | Title | Regulation Identification Number |
|---|---|---|
| 1100 | Hearing Aids; Professional and Patient Labeling; Conditions for Sale | 0910-AA39 |
| 1101 | Classification of Computer Software Programs That Are Medical Devices | 0910-AA41 |
| 1102 | Reinventing FDA Food Regulations | 0910-AA58 |
| 1103 | Part 600-Biological Products: General (Completion of a Section 610 Review) | 0910-AC06 |