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 2002 Unified Agenda for the Food
and Drug Administration.
|
Food and Drug Administration—Proposed Rule Stage |
|---|
Sequence Number |
Title |
Regulation Identification Number |
| 733 | Over-the-Counter (OTC) Drug Review | 0910-AA01 |
| 734 | Establishment Registration and Product Listing for Drugs and Biologics | 0910-AA49 |
| 735 | Investigational New Drugs: Export Requirements for Unapproved New Drug Products | 0910-AA61 |
| 736 | Safety Reporting Requirements for Human Drug and Biological Products | 0910-AA97 |
| 737 | Blood Initiative | 0910-AB26 |
| 738 | Applications for FDA Approval to Market a New Drug; Complete Response Letter; Amendments to Unapproved Applications | 0910-AB34 |
| 739 | Current Good Manufacturing Practice for Medicated Feeds | 0910-AB70 |
| 740 | Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Dietary Ingredients and Dietary Supplements | 0910-AB88 |
| 741 | Requirements for Submission of Labeling for Human Prescription Drugs and Biologics in Electronic Format | 0910-AB91 |
| 742 | Requirements Pertaining to Sampling Services and Private Laboratories Used in Connection With Imported Food | 0910-AB96 |
| 743 | Status Reports of Distribution and Use Information for Antimicrobial Animal Drug Products Used in Food-Producing Animals | 0910-AC04 |
| 744 | Control of Salmonella Enteritidis in Shell Eggs During Production and Retail | 0910-AC14 |
| 745 | Institutional Review Boards: Registration Requirements | 0910-AC17 |
| 746 | Aluminum in Large- and Small-Volume Parenterals Used in Total Parenteral Nutrition | 0910-AC18 |
| 747 | Use of Materials Derived From Bovine and Ovine Animals in FDA-Regulated Products | 0910-AC19 |
| 748 | Postmarketing Reports of Substandard or Ineffective Bulk Ingredients and Bulk Ingredients From Unapproved Sources | 0910-AC20 |
| 749 | Chronic Wasting Disease: Control of Food Products and Cosmetics Derived From Exposed Animal Populations | 0910-AC21 |
| 750 | Exception From General Requirements for Informed Consent; Request for Comments and Information | 0910-AC25 |
| 751 | Bar Code Label Requirements for Human Drug Products | 0910-AC26 |
| 752 | Medical Devices; Anesthesiology Devices; Proposed Reclassification of Pressure Regulators for Use With Medical Oxygen | 0910-AC30 |
| 753 | Medical Devices; Patient Examination and Surgeons' Gloves; Adulteration | 0910-AC32 |
| 754 | Amendments to the Performance Standard for Diagnostic X-Ray Systems and Their Major Components | 0910-AC34 |
|
Food and Drug Administration—Discontinued Entries |
|---|
Regulation Identification Number |
Title |
Date Withdrawn |
Comments |
| 0910-AA02 | New Animal Drug Approval Process; Implementation of Title I of the Generic Animal Drug and Patent Term Restoration Act (GADPTRA) | 03/20/2002 | Withdrawn - Publication is not projected in the next 12 months |
| 0910-AA19 | Food Labeling Review | 03/05/2002 | Withdrawn |
| 0910-AA20 | Medical Foods | 03/05/2002 | Withdrawn - Publication is not projected in the next 12 months |
| 0910-AA45 | Current Good Manufacturing Practice; Amendment of Certain Requirements for Finished Pharmaceuticals | 03/06/2002 | Withdrawn - Publication is not projected in the next 12 months |
| 0910-AA51 | Bioavailability and Bioequivalence Requirements | 03/06/2002 | Withdrawn - Publication is not projected in the next 12 months |
| 0910-AA86 | Safety Reporting and Recordkeeping Requirements for Marketed OTC Drugs | 03/06/2002 | Withdrawn - Publication is not projected in the next 12 months |
| 0910-AA90 | Direct-to-Consumer Promotion Regulations | 03/06/2002 | Withdrawn - Publication is not projected in the next 12 months |
| 0910-AA98 | Current Good Manufacturing Practice; Revision of Certain Labeling Controls | 03/06/2002 | Withdrawn - Publication is not projected in the next 12 months |
| 0910-AB00 | Radioactive Drugs for Basic Research | 03/06/2002 | Withdrawn - Publication is not projected in the next 12 months |
| 0910-AB14 | Administrative Practices and Procedures; Advisory Opinions and Guidelines | 03/06/2002 | Withdrawn - Publication is not projected in the next 12 months |
| 0910-AB33 | Antibiotic Drug Approval and Exclusivity | 03/06/2002 | Withdrawn - Publication is not projected in the next 12 months |
| 0910-AB37 | Expanded Access to Investigational Therapies | 03/06/2002 | Withdrawn - Publication is not projected in the next 12 months |
| 0910-AB42 | Electronic Submission of Postmarketing Safety Reports | 03/06/2002 | Withdrawn - Publication is not projected in the next 12 months |
| 0910-AB43 | Distinguishing Marks for Drug Products Containing Insulin | 03/06/2002 | Withdrawn - Publication is not projected in the next 12 months |
| 0910-AB44 | Pregnancy Labeling | 03/06/2002 | Withdrawn - Publication is not projected in the next 12 months |
| 0910-AB49 | Supplements and Other Changes to Approved New Animal Drug Applications | 03/05/2002 | Withdrawn |
| 0910-AB50 | Requirements for Liquid Medicated Feed and Free-Choice Medicated Feed | 03/05/2002 | Withdrawn |
| 0910-AB56 | Natural Rubber-Containing Drugs; User Labeling | 03/06/2002 | Withdrawn - Publication is not projected in the next 12 months |
| 0910-AB57 | Bulk Drug Substances for Use in Pharmacy Compounding | 03/06/2002 | Withdrawn - Publication is not projected in the next 12 months |
| 0910-AB58 | Pharmacy and Physician Compounding of Drug Products | 03/06/2002 | Withdrawn - Publication is not projected in the next 12 months |
| 0910-AB59 | Drug Products That Present Demonstrable Difficulties for Compounding Because of Reasons of Safety or Effectiveness | 03/06/2002 | Withdrawn - Publication is not projected in the next 12 months |
| 0910-AB60 | Discontinuation of a Lifesaving Product | 03/06/2002 | Withdrawn - Publication is not projected in the next 12 months |
| 0910-AB63 | Positron Emission Tomography Drugs; Current Good Manufacturing Practice | 03/06/2002 | Withdrawn - Publication is not projected in the next 12 months |
| 0910-AB68 | Presubmission Conferences | 03/05/2002 | Withdrawn |
| 0910-AB71 | Implementation of the Import Tolerance Provisions of the Animal Drug Availability Act of 1996 | 03/05/2002 | Withdrawn |
| 0910-AB72 | Mandatory HACCP Regulations for Manufacturers of Rendered Products | 03/05/2002 | Withdrawn |
| 0910-AB73 | Citizen Petitions; Actions That Can Be Requested by Petition; Denials, Withdrawals, and Referrals for Other Administrative Action | 03/05/2002 | Withdrawn - Publication is not projected in the next 12 months |
| 0910-AB74 | Surgeon's and Patient Examination Gloves; Reclassification | 03/13/2002 | Withdrawn - Publication is not projected in the next 12 months |
| 0910-AB79 | Fixed-Combination Prescription and Over-the-Counter Drugs for Human Use | 03/06/2002 | Withdrawn - Publication is not projected in the next 12 months |
| 0910-AB80 | 180-Day Generic Drug Exclusivity for Abbreviated New Drug Applications | 03/06/2002 | Withdrawn |
| 0910-AB81 | Repackaging Approval Requirements | 03/06/2002 | Withdrawn - Publication is not projected in the next 12 months |
| 0910-AB82 | Stability Testing of Drugs | 03/06/2002 | Withdrawn |
| 0910-AB90 | Substances Prohibited From Use in Animal Food or Feed | 03/05/2002 | Withdrawn |
| 0910-AB92 | Fees Relating to Drugs; Waiver and Reduction of Fees | 03/06/2002 | Withdrawn - Publication is not projected in the next 12 months |
| 0910-AB93 | Periodic Testing for Certain Human Drug, Veterinary Drug, and Biological Product Final Specifications | 03/06/2002 | Withdrawn - Publication is not projected in the next 12 months |
| 0910-AB99 | Medical Devices, Medical Device Establishment Registration and Listing Requirements; Amendment | 03/13/2002 | Withdrawn - Publication is not projected in the next 12 months |
| 0910-AC00 | Availability for Public Disclosure and Submission to FDA for Public Disclosure of Certain Data and Information Related to Gene Therapy or Xenotransplantation | 03/05/2002 | Withdrawn - Publication is not projected in the next 12 months |
| 0910-AC01 | Addition to the List of Drug Products That Have Been Withdrawn From the Market for Reasons of Safety or Effectiveness | 03/06/2002 | Withdrawn - Publication is not projected in the next 12 months |
| 0910-AC02 | Reporting Information Regarding Falsification of Data | 03/06/2002 | Withdrawn - Publication is not projected in the next 12 months |
| 0910-AC03 | Examination of Administrative Record and Other Advisory Committee Records | 03/06/2002 | Withdrawn - Publication is not projected in the next 12 months |
| 0910-AC08 | Addition to the List of Drug Products That Have Been Withdrawn or Removed From the Market for Reasons of Safety or Effectiveness | 03/06/2002 | Withdrawn - Publication is not projected in the next 12 months |
| 0910-AC09 | Labeling Dietary Supplements for Women Who Are or May Become Pregnant | 03/06/2002 | Withdrawn - Publication is not projected in the next 12 months |
| 0910-AC10 | Overwrap for Inhalation Products Packaged in Low Density Polyethylene (LDPE) Containers | 03/06/2002 | Withdrawn - Publication is not projected in the next 12 months |
| 0910-AC11 | Implementing Court Decisions, ANDA Approvals, and 180-Day Exclusivity | 03/06/2002 | Withdrawn - Publication is not projected in the next 12 months |
| 0910-AC13 | Regulation of Carcinogenic Compounds Used in Food-Producing Animals; Definition of "No Residue" | 03/20/2002 | Withdrawn - Publication is not projected in the next 12 months |
| 0910-AC16 | Rescission of Substantially Equivalent Decisions and Rescission Appeal Procedures | 03/05/2002 | Withdrawn - Publication is not projected in the next 12 months |
| 0910-AC24 | Requirements for Medical Gas Containers and Closure Systems | 03/06/2002 | Withdrawn - Publication is not projected in the next 12 months |
| 0910-AC27 | Promotion and Charging For Investigational Drugs | 03/06/2002 | Withdrawn - Publication is not projected in the next 12 months |
