Regulatory Information
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Spring 2003: 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 2003 Unified Agenda for the Food and Drug Administration.
| Food and Drug Administration—Prerule Stage | ||
|---|---|---|
| Sequence Number | Title | Regulation Identification Number |
| 765 | Over-the-Counter (OTC) Drug Review | 0910-AA01 |
| 766 | Investigational Use New Animal Drug Regulations (Section 610 Review) | 0910-AB02 |
| 767 | Food Labeling: Trans Fatty Acids in Nutrition Labeling: Consumer Research To Consider Possible Footnote Statements | 0910-AC50 |
| 768 | Part 110—Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Human Food (Section 610 Review) | 0910-AC58 |
| Food and Drug Administration—Proposed Rule Stage | ||
|---|---|---|
| Sequence Number | Title | Regulation Identification Number |
| 769 | Foreign and Domestic Establishment Registration and Listing Requirements for Drugs and Biologics | 0910-AA49 |
| 770 | Blood Initiative | 0910-AB26 |
| 771 | Applications for FDA Approval To Market a New Drug; Complete Response Letter; Amendments To Unapproved Applications | 0910-AB34 |
| 772 | Current Good Manufacturing Practice for Medicated Feeds | 0910-AB70 |
| 773 | Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Dietary Ingredients and Dietary Supplements | 0910-AB88 |
| 774 | Requirements Pertaining to Sampling Services and Private Laboratories Used in Connection With Imported Food | 0910-AB96 |
| 775 | Prevention of Salmonella Enteritidis in Shell Eggs | 0910-AC14 |
| 776 | Institutional Review Boards: Registration Requirements | 0910-AC17 |
| 777 | Use of Materials Derived From Bovine and Ovine Animals in FDA-Regulated Products | 0910-AC19 |
| 778 | Chronic Wasting Disease: Control of Food Products and Cosmetics Derived From Exposed Animal Populations | 0910-AC21 |
| 779 | Requirements for Submission of In Vivo Bioequivalence Data | 0910-AC23 |
| 780 | Exception From General Requirements for Informed Consent; Request for Comments and Information | 0910-AC25 |
| 781 | Medical Devices; Anesthesiology Devices; Proposed Reclassification of Pressure Regulators for Use With Medical Oxygen | 0910-AC30 |
| 782 | Medical Devices; Patient Examination and Surgeons' Gloves; Adulteration | 0910-AC32 |
| 783 | Toll-Free Number for Reporting Adverse Events on Labeling for Human Drugs | 0910-AC35 |
| 784 | Administrative Detention of Food for Human or Animal Consumption Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 | 0910-AC38 |
| 785 | Establishment and Maintenance of Records Pursuant to the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 | 0910-AC39 |
| 786 | Requirements for Liquid Medicated Feed and Free-Choice Medicated Feed | 0910-AC43 |
| 787 | Submission of Standardized Electronic Study Data From Clinical Studies Evaluating Human Drugs and Biologics | 0910-AC52 |
| 788 | Medical Gas Containers and Closures; Current Good Manufacturing Practice Requirements | 0910-AC53 |
| 789 | Food Standards: General Principles and Food Standards Modernization | 0910-AC54 |
| 790 | Positron Emission Tomography Drugs; Current Good Manufacturing Practices | 0910-AC55 |
| 791 | Revision of the Requirements for Spore-Forming Microorganisms | 0910-AC57 |
| 792 | Reporting Information Regarding Falsification of Data | 0910-AC59 |
| Food and Drug Administration—Final Rule Stage | ||
|---|---|---|
| Sequence Number | Title | Regulation Identification Number |
| 793 | Infant Formula: Requirements Pertaining to Good Manufacturing Practice, Quality Control Procedures, Quality Factors, Notification Requirements, and Records and Reports | 0910-AA04 |
| 794 | Investigational New Drugs: Export Requirements for Unapproved New Drug Products | 0910-AA61 |
| 795 | Determination That Informed Consent Is Infeasible or Is Contrary to the Best Interest of Recipients | 0910-AA89 |
| 796 | Labeling for Human Prescription Drugs; Revised Format | 0910-AA94 |
| 797 | Supplements and Other Changes to an Approved Application | 0910-AB61 |
| 798 | Food Labeling: Trans Fatty Acids in Nutrition Labeling, Nutrient Content Claims, and Health Claims | 0910-AB66 |
| 799 | CGMP for Blood and Blood Components: Notification of Consignees and Transfusion Recipients Receiving Blood and Blood Components at Increased Risk of Transmitting HCV Infection (Lookback) | 0910-AB76 |
| 800 | Requirements for Submission of Labeling for Human Prescription Drugs and Biologics in Electronic Format | 0910-AB91 |
| 801 | Additional Safeguards for Children in Clinical Investigations of FDA-Regulated Products | 0910-AC07 |
| 802 | Aluminum in Large- and Small-Volume Parenterals Used in Total Parenteral Nutrition | 0910-AC18 |
| 803 | Bar Code Label Requirements for Human Drug Products and Blood | 0910-AC26 |
| 804 | Amendments to the Performance Standard for Diagnostic X-Ray Systems and Their Major Components | 0910-AC34 |
| 805 | Registration of Food and Animal Feed Facilities | 0910-AC40 |
| 806 | Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 | 0910-AC41 |
| 807 | Presubmission Conferences | 0910-AC44 |
| 808 | Applications for FDA Approval To Market a New Drug: Patent Listing Requirements and Application of 30-Month Stays on Approval of Abbreviated New Drug Applications | 0910-AC48 |
| 809 | Biological Products; Bacterial Vaccines and Toxoids; Implementation of Efficacy Review | 0910-AC56 |
| Food and Drug Administration—Long-Term Actions | ||
|---|---|---|
| Sequence Number | Title | Regulation Identification Number |
| 810 | Safety Reporting Requirements for Human Drug and Biological Products | 0910-AA97 |
| 811 | Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products | 0910-AB27 |
| 812 | Current Good Tissue Practice for Human Cell, Tissue, and Cellular and Tissue-Based Products Establishments; Inspection and Enforcement | 0910-AB28 |
| 813 | Regulation of Carcinogenic Compounds Used in Food-Producing Animals; Definition of "No Residue" | 0910-AC45 |
| Food and Drug Administration—Completed Actions | ||
|---|---|---|
| Sequence Number | Title | Regulation Identification Number |
| 814 | Revisions to the General Safety Requirements for Biological Products; Final Rule | 0910-AB51 |
| 815 | Antibiotic Resistance Labeling | 0910-AB78 |
| 816 | Records and Reports Concerning Experience With Approved New Animal Drugs | 0910-AC42 |
| 817 | Bioavailability and Bioequivalence Requirements | 0910-AC47 |
| Food and Drug Administration—Discontinued Entries | |||
|---|---|---|---|
| Regulation Identification Number | Title | Date | Comments |
| 0910-AC15 | Premarket Notice Concerning Bioengineered Foods | 02/13/2003 | Withdrawn--Publication not expected in the next 12 months |
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