Regulatory Information
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Spring 2001: Unified Agenda of Federal Regulatory and Deregulatory Actions
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 Spring 2001 Unified Agenda for the Food and Drug Administration.
| Food and Drug Administration—Prerule Stage | ||
|---|---|---|
| Sequence Number | Title | Regulation Identification Number |
| 831 | Natural Rubber-Containing Drugs; User Labeling | 0910-AB56 |
| 832 | Implementation of the Import Tolerance Provisions of the Animal Drug Availability Act of 1996 | 0910-AB71 |
| 833 | Part 600-Biological Products: General (Section 610 Review) | 0910-AC06 |
| Food and Drug Administration—Proposed Rule Stage | ||
|---|---|---|
| Sequence Number | Title | Regulation Identification Number |
| 834 | Over-the-Counter (OTC) Drug Review | 0910-AA01 |
| 835 | Hearing Aids; Professional and Patient Labeling; Conditions for Sale | 0910-AA39 |
| 836 | Establishment Registration and Product Listing for Drugs and Biologics | 0910-AA49 |
| 837 | Investigational New Drugs: Export Requirements for Unapproved New Drug Products | 0910-AA61 |
| 838 | Safety Reporting and Recordkeeping Requirements for Marketed OTC Drugs | 0910-AA86 |
| 839 | Safety Reporting Requirements for Human Drug and Biological Products | 0910-AA97 |
| 840 | Radioactive Drugs for Basic Research | 0910-AB00 |
| 841 | Administrative Practices and Procedures; Advisory Opinions and Guidelines | 0910-AB14 |
| 842 | Current Good Tissue Practice for Manufacturers of Human Cellular and Tissue-Based Products | 0910-AB28 |
| 843 | Applications for FDA Approval to Market a New Drug; Complete Response Letter; Amendments to Unapproved Applications | 0910-AB34 |
| 844 | Expanded Access to Investigational Therapies | 0910-AB37 |
| 845 | Electronic Submission of Adverse Drug Reaction Reports | 0910-AB42 |
| 846 | Distinguishing Marks for Drug Products Containing Insulin | 0910-AB43 |
| 847 | Pregnancy Labeling | 0910-AB44 |
| 848 | Positron Emission Tomography Drugs; Current Good Manufacturing Practices | 0910-AB63 |
| 849 | Current Good Manufacturing Practice for Medicated Feeds | 0910-AB70 |
| 850 | Fixed-Combination Prescription and Over-the-Counter Drugs for Human Use | 0910-AB79 |
| 851 | Repackaging Approval Requirements | 0910-AB81 |
| 852 | Stability Testing of Drugs | 0910-AB82 |
| 853 | Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Dietary Supplements | 0910-AB88 |
| 854 | Submission in Electronic Format of Certain Labeling Information | 0910-AB91 |
| 855 | Fees Relating to Drugs; Waiver and Reduction of Fees | 0910-AB92 |
| 856 | Periodic Testing for Certain Human Drug, Veterinary Drug, and Biological Product Final Specifications | 0910-AB93 |
| 857 | Requirements Pertaining to Sampling Services and Private Laboratories Used in Connection with Imported Food | 0910-AB96 |
| 858 | Medical Devices, Medical Device Establishment Registration and Listing Requirements; Amendment | 0910-AB99 |
| 859 | Availability for Public Disclosure and Submission to FDA for Public Disclosure of Certain Data and Information Related to Gene Therapy or Xenotransplantation | 0910-AC00 |
| 860 | Reporting Information Regarding Potential Fabrication or Falsification of Data | 0910-AC02 |
| 861 | Status Reports for Quantity Marketed Information for Animal Drug Products Used in Food-Producing Animals | 0910-AC04 |
| 862 | Labeling Dietary Supplements for Women Who Are or May Become Pregnant | 0910-AC09 |
| 863 | Overwrap for Inhalation Products Packaged in Low Density Polyethylene (LDPE) Containers | 0910-AC10 |
| 864 | Regulation of Carcinogenic Compounds Used in Food-Producing Animals; Definition of "No Residue" | 0910-AC13 |
| 865 | Control of Salmonella Enteritidis in Shell Eggs During Production and Retail | 0910-AC14 |
| 866 | Aluminum in Large and Small Volume Parenterals Used in Total Parenteral Nutrition | 0910-AC18 |
| 867 | Use of Materials Derived from Ruminant Animals in FDA Regulated Products | 0910-AC19 |
| 868 | Postmarketing Reports of Substandard or Ineffective Bulk Ingredients and Bulk Ingredients from Unapproved Sources | 0910-AC20 |
| Food and Drug Administration—Final Rule Stage | ||
|---|---|---|
| Sequence Number | Title | Regulation Identification Number |
| 869 | New Animal Drug Approval Process; Implementation of Title I of the Generic Animal Drug and Patent Term Restoration Act (GADPTRA) | 0910-AA02 |
| 870 | Current Good Manufacturing Practice; Amendment of Certain Requirements for Finished Pharmaceuticals | 0910-AA45 |
| 871 | Bioavailability and Bioequivalence Requirements | 0910-AA51 |
| 872 | Labeling for Human Prescription Drugs; Revised Format | 0910-AA94 |
| 873 | Current Good Manufacturing Practice; Revision of Certain Labeling Controls | 0910-AA98 |
| 874 | Use of Ozone-Depleting Substances | 0910-AA99 |
| 875 | Exports; Notification and Recordkeeping Requirements | 0910-AB16 |
| 876 | Foreign Establishment Registration and Listing | 0910-AB21 |
| 877 | 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 |
| 878 | Blood Initiative | 0910-AB26 |
| 879 | Antibiotic Drug Approval and Exclusivity | 0910-AB33 |
| 880 | Amendment of Regulations Regarding Certain Label Statements on Prescription Drugs | 0910-AB39 |
| 881 | Supplements and Other Changes to Approved New Animal Drug Applications | 0910-AB49 |
| 882 | Revisions to the General Safety Requirements for Biological Products; Direct Final Rule | 0910-AB51 |
| 883 | Discontinuation of a Lifesaving Product | 0910-AB60 |
| 884 | Supplements and Other Changes to an Approved Application | 0910-AB61 |
| 885 | Food Labeling: Trans Fatty Acids in Nutrition Labeling, Nutrient Content Claims, and Health Claims | 0910-AB66 |
| 886 | Presubmission Conferences | 0910-AB68 |
| 887 | Surgeon's and Patient Examination Gloves; Reclassification | 0910-AB74 |
| 888 | CGMPs for Blood and Blood Components: Notification of Consignees and Transfusion Recipients Receiving Blood and Blood Components at Increased Risk of Transmitting HCV (Lookback) | 0910-AB76 |
| 889 | Antibiotic Resistance Labeling | 0910-AB78 |
| 890 | 180-Day Generic Drug Exclusivity for Abbreviated New Drug Applications | 0910-AB80 |
| 891 | Food Additives: Food Contact Substances Notification System | 0910-AB94 |
| 892 | State Certification of Mammography Facilities | 0910-AB98 |
| 893 | Examination of Administrative Record and Other Advisory Committee Records | 0910-AC03 |
| 894 | Efficacy Evidence Needed for Products to be Used Against Toxic Substances When Human Studies Are Unethical | 0910-AC05 |
| 895 | Additional Safeguards for Children in Clinical Investigations of FDA Regulated Products | 0910-AC07 |
| 896 | Implementing Court Decisions, ANDA Approvals, and 180-Day Exclusivity | 0910-AC11 |
| 897 | Revocation of Conditions for Marketing Digoxin Products for Oral Use | 0910-AC12 |
| Food and Drug Administration—Long-Term Actions | ||
|---|---|---|
| Sequence Number | Title | Regulation Identification Number |
| 898 | Infant Formula: Good Manufacturing Practice, Quality Control Procedures, Quality Factors, Notification Requirements, and Records and Reports | 0910-AA04 |
| 899 | Food Labeling Review | 0910-AA19 |
| 900 | Medical Foods | 0910-AA20 |
| 901 | Classification of Computer Software Programs That Are Medical Devices | 0910-AA41 |
| 902 | Reinventing FDA Food Regulations | 0910-AA58 |
| 903 | Determination That Informed Consent Is Infeasible or Is Contrary to the Best Interest of Recipients | 0910-AA89 |
| 904 | Direct-to-Consumer Promotion Regulations | 0910-AA90 |
| 905 | Investigational Use New Animal Drug Regulations (Section 610 Review) | 0910-AB02 |
| 906 | Suitability Determination for Donors of Human Cellular and Tissue-Based Products | 0910-AB27 |
| 907 | Requirements for Liquid Medicated Feed and Free-Choice Medicated Feed | 0910-AB50 |
| 908 | Bulk Drug Substances for Use in Pharmacy Compounding | 0910-AB57 |
| 909 | Pharmacy and Physician Compounding of Drug Products | 0910-AB58 |
| 910 | Drug Products That Present Demonstrable Difficulties for Compounding Because of Reasons of Safety or Effectiveness | 0910-AB59 |
| 911 | Mandatory HACCP Regulations for Manufacturers of Rendered Products | 0910-AB72 |
| 912 | Citizen Petitions; Actions That Can Be Requested by Petition; Denials, Withdrawals, and Referrals for Other Administrative Action | 0910-AB73 |
| 913 | Substances Prohibited From Use in Animal Food or Feed | 0910-AB90 |
| 914 | Marking Requirements for and Prohibitions on the Reimportation of Imported Food Products That Have Been Refused Admission into the United States | 0910-AB95 |
| 915 | Addition to the List of Drug Products That Have Been Withdrawn From the Market for Reasons of Safety or Effectiveness | 0910-AC01 |
| 916 | Addition to the List of Drug Products That Have Been Withdrawn or Removed From the Market for Reasons of Safety or Effectiveness | 0910-AC08 |
| 917 | Premarket Notice Concerning Bioengineered Foods | 0910-AC15 |
| 918 | Rescission of Substantially Equivalent Decisions and Rescission Appeal Procedures | 0910-AC16 |
| 919 | Institutional Review Boards: Registration Requirements | 0910-AC17 |
| 920 | 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 |
| 921 | Biological Products: Reporting of Biological Product Deviations in Manufacturing | 0910-AA12 |
| 922 | Fruit and Vegetable Juices: Development of HACCP and Label Warning Statements for Juices | 0910-AA43 |
| 923 | Drugs Used for Treatment of Narcotic Addicts | 0910-AA52 |
| 924 | Establishment Registration and Listing of Human Cells, Tissues, and Cellular and Tissue-Based Products | 0910-AB05 |
| 925 | Veterinary Feed Directives | 0910-AB09 |
| 926 | Shell Eggs: Warning, Notice and Safe Handling Labeling Statements and Refrigeration Requirements | 0910-AB30 |
| 927 | Postmarketing Studies for Human Drugs and Licensed Biological Products: Status Reports | 0910-AB83 |
| 928 | Current Good Manufacturing Practice for Blood and Blood Components; Blood Labeling Standards | 0910-AB89 |
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