Regulatory Information
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Fall 2002: 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 Fall 2002 Unified Agenda for the Food and Drug Administration.
| Food and Drug Administration—Prerule Stage | ||
|---|---|---|
| Sequence Number | Title | Regulation Identification Number |
| 930 | Requirements for Submission of In Vivo Bioequivalence Data | 0910-AC23 |
| Food and Drug Administration—Proposed Rule Stage | ||
|---|---|---|
| Sequence Number | Title | Regulation Identification Number |
| 931 | Establishment Registration and Listing for Drugs and Biologics | 0910-AA49 |
| 932 | Safety Reporting Requirements for Human Drug and Biological Products (Reg Plan Seq No. 31) | 0910-AA97 |
| 933 | Blood Initiative | 0910-AB26 |
| 934 | Applications for FDA Approval to Market a New Drug; Complete Response Letter; Amendments to Unapproved Applications | 0910-AB34 |
| 935 | Current Good Manufacturing Practice for Medicated Feeds | 0910-AB70 |
| 936 | Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Dietary Ingredients and Dietary Supplements (Reg Plan Seq No. 32) | 0910-AB88 |
| 937 | Requirements Pertaining to Sampling Services and Private Laboratories Used in Connection With Imported Food | 0910-AB96 |
| 938 | Control of Salmonella Enteritidis in Shell Eggs During Production and Retail (Reg Plan Seq No. 33) | 0910-AC14 |
| 939 | Institutional Review Boards: Registration Requirements | 0910-AC17 |
| 940 | Chronic Wasting Disease: Control of Food Products and Cosmetics Derived From Exposed Animal Populations | 0910-AC21 |
| 941 | Exception From General Requirements for Informed Consent; Request for Comments and Information (Reg Plan Seq No. 34) | 0910-AC25 |
| 942 | Bar Code Label Requirements for Human Drug Products (Reg Plan Seq No. 35) | 0910-AC26 |
| 943 | Medical Devices; Patient Examination and Surgeons' Gloves; Adulteration | 0910-AC32 |
| 944 | Amendments to the Performance Standard for Diagnostic X-Ray Systems and Their Major Components | 0910-AC34 |
| 945 | Administrative Detention (Reg Plan Seq No. 36) | 0910-AC38 |
| 946 | Establishment and Maintenance of Records to Identify Immediate Previous Source and Immediate Subsequent Recipient of Foods (Reg Plan Seq No. 37) | 0910-AC39 |
| 947 | Registration of Food and Animal Feed Facilities (Reg Plan Seq No. 38) | 0910-AC40 |
| 948 | Establishment of Prior Notification Requirement for All Imported Food Shipments (Reg Plan Seq No. 39) | 0910-AC41 |
| 949 | Requirements for Liquid Medicated Feed and Free-Choice Medicated Feed | 0910-AC43 |
| 950 | 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 (Reg Plan Seq No. 40) | 0910-AC48 |
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 |
| 951 | Over-the-Counter (OTC) Drug Review | 0910-AA01 |
| 952 | Investigational New Drugs: Export Requirements for Unapproved New Drug Products | 0910-AA61 |
| 953 | Determination That Informed Consent Is Infeasible or Is Contrary to the Best Interest of Recipients | 0910-AA89 |
| 954 | Labeling for Human Prescription Drugs; Revised Format (Reg Plan Seq No. 41) | 0910-AA94 |
| 955 | Revisions to the General Safety Requirements for Biological Products; Final Rule | 0910-AB51 |
| 956 | Supplements and Other Changes to an Approved Application | 0910-AB61 |
| 957 | Food Labeling: Trans Fatty Acids in Nutrition Labeling, Nutrient Content Claims, and Health Claims (Reg Plan Seq No. 42) | 0910-AB66 |
| 958 | 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. 43) | 0910-AB76 |
| 959 | Antibiotic Resistance Labeling | 0910-AB78 |
| 960 | Requirements for Submission of Labeling for Human Prescription Drugs and Biologics in Electronic Format | 0910-AB91 |
| 961 | Additional Safeguards for Children in Clinical Investigations of FDA Regulated Products | 0910-AC07 |
| 962 | Aluminum in Large- and Small-Volume Parenterals Used in Total Parenteral Nutrition | 0910-AC18 |
| 963 | Toll-Free Number for Reporting Adverse Events on Labeling for Human Drugs (Reg Plan Seq No. 44) | 0910-AC35 |
| 964 | Records and Reports Concerning Experience With Approved New Animal Drugs | 0910-AC42 |
| 965 | Presubmission Conferences | 0910-AC44 |
| 966 | Regulation of Carcinogenic Compounds Used in Food-Producing Animals; Definition of "No Residue" | 0910-AC45 |
| 967 | Bioavailability and Bioequivalence Requirements | 0910-AC47 |
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 |
| 968 | Infant Formula: Requirements Pertaining to Good Manufacturing Practice, Quality Control Procedures, Quality Factors, Notification Requirements, and Records and Reports | 0910-AA04 |
| 969 | Investigational Use New Animal Drug Regulations (Section 610 Review) | 0910-AB02 |
| 970 | Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) | 0910-AB27 |
| 971 | Current Good Tissue Practice for Manufacturers of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps); Inspection and Enforcement | 0910-AB28 |
| 972 | Premarket Notice Concerning Bioengineered Foods | 0910-AC15 |
| 973 | Use of Materials Derived From Bovine and Ovine Animals in FDA-Regulated Products | 0910-AC19 |
| 974 | Medical Devices; Anesthesiology Devices; Proposed Reclassification of Pressure Regulators for Use With Medical Oxygen | 0910-AC30 |
| Food and Drug Administration—Completed Actions | ||
|---|---|---|
| Sequence Number | Title | Regulation Identification Number |
| 975 | Use of Ozone-Depleting Substances | 0910-AA99 |
| 976 | Food Additives: Food Contact Substances Notification System | 0910-AB94 |
| 977 | Efficacy Evidence Needed for Products To Be Used Against Toxic Substances When Human Studies Are Unethical | 0910-AC05 |
| 978 | Revocation of Conditions for Marketing Digoxin Products for Oral Use | 0910-AC12 |
| 979 | Postmarket Surveillance | 0910-AC31 |
| Food and Drug Administration—Discontinued Entries | |||
|---|---|---|---|
| Regulation Identification Number | Title | Date | Comments |
| 0910-AB24 | 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 | 08/02/2002 | Withdrawn |
| 0910-AB95 | Marking Requirements for and Prohibitions on the Reimportation of Imported Food Products That Have Been Refused Admission Into the United States | 08/02/2002 | Withdrawn |
| 0910-AC04 | Status Reports of Distribution and Use Information for Antimicrobial Animal Drug Products Used in Food-Producing Animals | 07/31/2002 | Withdrawn |
| 0910-AC20 | Postmarketing Reports of Substandard or Ineffective Bulk Ingredients and Bulk Ingredients From Unapproved Sources | 08/02/2002 | Withdrawn |
| 0910-AC33 | Redacting 510(k) Submissions | 09/18/2002 | Withdrawn |
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