Regulatory Information
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Fall 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 Fall 2003 Unified Agenda for the Food and Drug Administration.
| Food and Drug Administration—Prerule Stage | ||
|---|---|---|
| Sequence Number | Title | Regulation Identification Number |
| 978 | Over-the-Counter (OTC) Drug Review | 0910-AA01 |
| 979 | Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Human Food (Part 110) (Section 610 Review) | 0910-AC58 |
| 980 | Health Claims | 0910-AF09 |
| 981 | Prescription Drug Marketing Act of 1987; Prescription Drug Amendments of 1992; Policies, Requirements, and Administrative Procedures; Derivatives of Blood | 0910-AF16 |
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 |
| 982 | Foreign and Domestic Establishment Registration and Listing Requirements for Drugs and Biologics | 0910-AA49 |
| 983 | Blood Initiative | 0910-AB26 |
| 984 | Applications for FDA Approval To Market a New Drug; Complete Response Letter; Amendments To Unapproved Applications | 0910-AB34 |
| 985 | Current Good Manufacturing Practice for Medicated Feeds | 0910-AB70 |
| 986 | Requirements Pertaining to Sampling Services and Private Laboratories Used in Connection With Imported Food | 0910-AB96 |
| 987 | Prevention of Salmonella Enteritidis in Shell Eggs (Reg Plan Seq No. 42) | 0910-AC14 |
| 988 | Institutional Review Boards: Registration Requirements | 0910-AC17 |
| 989 | Use of Materials Derived From Bovine and Ovine Animals in FDA-Regulated Products | 0910-AC19 |
| 990 | Chronic Wasting Disease: Control of Food Products and Cosmetics Derived From Exposed Animal Populations | 0910-AC21 |
| 991 | Exception From General Requirements for Informed Consent; Request for Comments and Information (Reg Plan Seq No. 43) | 0910-AC25 |
| 992 | Medical Devices; Anesthesiology Devices; Proposed Reclassification of Pressure Regulators for Use With Medical Oxygen | 0910-AC30 |
| 993 | Toll-Free Number for Reporting Adverse Events on Labeling for Human Drugs (Reg Plan Seq No. 44) | 0910-AC35 |
| 994 | Food Labeling: Trans Fatty Acids in Nutrition Labeling: Consumer Research To Consider Nutrient Content and Health Claims and Possible Footnote or Disclosure Statements | 0910-AC50 |
| 995 | Submission of Standardized Electronic Study Data From Clinical Studies Evaluating Human Drugs and Biologics | 0910-AC52 |
| 996 | Medical Gas Containers and Closures; Current Good Manufacturing Practice Requirements | 0910-AC53 |
| 997 | Food Standards: General Principles and Food Standards Modernization | 0910-AC54 |
| 998 | Positron Emission Tomography Drugs; Current Good Manufacturing Practices | 0910-AC55 |
| 999 | Revision of the Requirements for Spore-Forming Microorganisms | 0910-AC57 |
| 1000 | Reporting Information Regarding Falsification of Data | 0910-AC59 |
| 1001 | Definition of "Serious Adverse Health Consequences" Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Reg Plan Seq No. 45) | 0910-AF06 |
| 1002 | Quality Standard Regulation Establishing Allowable Level for Arsenic in Bottled Water | 0910-AF10 |
| 1003 | Content and Format of Labeling for Human Prescription Drugs and Biologics; Requirements for Pregnancy and Lactation | 0910-AF11 |
| 1004 | Cochineal Extract and Carmine Label Declaration | 0910-AF12 |
| 1005 | Charging for Investigational Drugs | 0910-AF13 |
| 1006 | Treatment Use of Investigational Drugs | 0910-AF14 |
| 1007 | Human Subject Protection; Foreign Clinical Studies Not Conducted Under an Investigational New Drug Application | 0910-AF15 |
| 1008 | Use of Ozone-Depleting Substances: Removal of Essential Use Designation; Albuterol (Reg Plan Seq No. 46) | 0910-AF18 |
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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 |
| 1009 | Infant Formula: Requirements Pertaining to Good Manufacturing Practice, Quality Control Procedures, Quality Factors, Notification Requirements, and Records and Reports | 0910-AA04 |
| 1010 | Investigational New Drugs: Export Requirements for Unapproved New Drug Products | 0910-AA61 |
| 1011 | Determination That Informed Consent Is Infeasible or Is Contrary to the Best Interest of Recipients | 0910-AA89 |
| 1012 | Labeling for Human Prescription Drugs; Revised Format (Reg Plan Seq No. 47) | 0910-AA94 |
| 1013 | Safety Reporting Requirements for Human Drug and Biological Products (Reg Plan Seq No. 48) | 0910-AA97 |
| 1014 | Supplements and Other Changes to an Approved Application | 0910-AB61 |
| 1015 | 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) Reg Plan Seq No. 49) | 0910-AB76 |
| 1016 | Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Dietary Ingredients and Dietary Supplements Reg Plan Seq No. 50) | 0910-AB88 |
| 1017 | Requirements for Submission of Labeling for Human Prescription Drugs and Biologics in Electronic Format | 0910-AB91 |
| 1018 | Additional Safeguards for Children in Clinical Investigations of FDA-Regulated Products | 0910-AC07 |
| 1019 | Bar Code Label Requirements for Human Drug Products and Blood Reg Plan Seq No. 51) | 0910-AC26 |
| 1020 | Medical Devices; Patient Examination and Surgeons' Gloves; Adulteration | 0910-AC32 |
| 1021 | Amendments to the Performance Standard for Diagnostic X-Ray Systems and Their Major Components | 0910-AC34 |
| 1022 | Administrative Detention of Food for Human or Animal Consumption Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 Reg Plan Seq No. 52) | 0910-AC38 |
| 1023 | Establishment and Maintenance of Records Pursuant to the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 Reg Plan Seq No. 53) | 0910-AC39 |
| 1024 | Registration of Food and Animal Feed Facilities | 0910-AC40 |
| 1025 | Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 | 0910-AC41 |
| 1026 | Requirements for Liquid Medicated Feed and Free-Choice Medicated Feed | 0910-AC43 |
| 1027 | Presubmission Conferences | 0910-AC44 |
| 1028 | Biological Products; Bacterial Vaccines and Toxoids; Implementation of Efficacy Review | 0910-AC56 |
| 1029 | Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs; Revision of Certain Labeling Controls | 0910-AF08 |
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| Food and Drug Administration—Long-term Actions | ||
|---|---|---|
| Sequence Number | Title | Regulation Identification Number |
| 1030 | Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products | 0910-AB27 |
| 1031 | Current Good Tissue Practice for Human Cell, Tissue, and Cellular and Tissue-Based Products Establishments; Inspection and Enforcement | 0910-AB28 |
| 1032 | Requirements for Submission of In Vivo Bioequivalence Data | 0910-AC23 |
| 1033 | Food Labeling: Food Allergen Ingredient Labeling | 0910-AF07 |
| Food and Drug Administration—Completed Actions | ||
|---|---|---|
| Sequence Number | Title | Regulation Identification Number |
| 1034 | Investigational Use New Animal Drug Regulations (Completion of a Section 610 Review) | 0910-AB02 |
| 1035 | Food Labeling: Trans Fatty Acids in Nutrition Labeling, Nutrient Content Claims, and Health Claims | 0910-AB66 |
| 1036 | Aluminum in Large- and Small-Volume Parenterals Used in Total Parenteral Nutrition | 0910-AC18 |
| 1037 | Regulation of Carcinogenic Compounds Used in Food-Producing Animals; Definition of "No Residue" | 0910-AC45 |
| 1038 | 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 |
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