Regulatory Information
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Spring 2004: 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 2004 Unified Agenda for the Food and Drug Administration.
| Food and Drug Administration--Prerule Stage | ||
|---|---|---|
| Sequence Number | Title | Regulation Identification Number |
| 833 | Safety Reporting Requirements for Human Drug and Biological Products | 0910-AA97 |
| 834 | Food Labeling; Prominence of Calories | 0910-AF22 |
| 835 | Food Labeling; Serving Sizes | 0910-AF23 |
| 836 | Over-the-Counter (OTC) Drug Review—Sunscreen Products | 0910-AF43 |
| Food and Drug Administration—Proposed Rule Stage | ||
|---|---|---|
| Sequence Number | Title | Regulation Identifier Number |
| 837 | Foreign and Domestic Establishment Registration and Listing Requirements for Drugs and Biologics | 0910-AA49 |
| 838 | Applications for FDA Approval To Market a New Drug; Complete Response Letter; Amendments To Unapproved Applications | 0910-AB34 |
| 839 | Prevention of Salmonella Enteritidis in Shell Eggs | 0910-AC14 |
| 840 | Exception From General Requirements for Informed Consent; Request for Comments and Information | 0910-AC25 |
| 841 | Medical Devices; Anesthesiology Devices; Proposed Reclassification of Pressure Regulators for Use With Medical Oxygen | 0910-AC30 |
| 842 | Food Standards: General Principles and Food Standards Modernization | 0910-AC54 |
| 843 | Positron Emission Tomography Drugs; Current Good Manufacturing Practices | 0910-AC55 |
| 844 | Reporting Information Regarding Falsification of Data | 0910-AC59 |
| 845 | Definition of "Serious Adverse Health Consequences" Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 | 0910-AF06 |
| 846 | Health Claims | 0910-AF09 |
| 847 | Quality Standard Regulation Establishing Allowable Level for Arsenic in Bottled Water | 0910-AF10 |
| 848 | Content and Format of Labeling for Human Prescription Drugs and Biologics; Requirements for Pregnancy and Lactation | 0910-AF11 |
| 849 | Cochineal Extract and Carmine Label Declaration | 0910-AF12 |
| 850 | Charging for Investigational Drugs | 0910-AF13 |
| 851 | Treatment Use of Investigational Drugs | 0910-AF14 |
| 852 | Prescription Drug Marketing Act of 1987; Prescription Drug Amendments of 1992; Policies, Requirements, and Administrative Procedures; Derivatives of Blood | 0910-AF16 |
| 853 | Use of Ozone-Depleting Substances: Removal of Essential Use Designation; Albuterol | 0910-AF18 |
| 854 | Revocation of the Status of Specific Products; Group A Streptococcus | 0910-AF20 |
| 855 | Latex Condoms: Special Controls | 0910-AF21 |
| 856 | Blood Initiative—Regulations for Human Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use | 0910-AF25 |
| 857 | Over-the-Counter (OTC) Drug Review—Cough/Cold (Bronchodilator) Products | 0910-AF32 |
| 858 | Over-the-Counter (OTC) Drug Review—Cough/Cold (Combination) Products | 0910-AF33 |
| 859 | Over-the-Counter (OTC) Drug Review—Cough/Cold (Nasal Decongestant) Products | 0910-AF34 |
| 860 | Over-the-Counter (OTC) Drug Review—Internal Analgesic Products | 0910-AF36 |
| 861 | Over-the-Counter (OTC) Drug Review—Labeling of Drug Products for OTC Human Use | 0910-AF37 |
| 862 | Over-the-Counter (OTC) Drug Review—Weight Control Products | 0910-AF45 |
| Food and Drug Administration—Final Rule Stage | ||
|---|---|---|
| Sequence Number | Title | Regulation Identifier Number |
| 863 | Investigational New Drugs: Export Requirements for Unapproved New Drug Products | 0910-AA61 |
| 864 | Labeling for Human Prescription Drugs; Revised Format | 0910-AA94 |
| 865 | Current Good Tissue Practice for Human Cell, Tissue, and Cellular and Tissue-Based Product Establishments; Inspection and Enforcement | 0910-AB28 |
| 866 | 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 |
| 867 | Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Dietary Ingredients and Dietary Supplements | 0910-AB88 |
| 868 | Additional Safeguards for Children in Clinical Investigations of FDA-Regulated Products | 0910-AC07 |
| 869 | Medical Devices; Patient Examination and Surgeons' Gloves; Adulteration | 0910-AC32 |
| 870 | Amendments to the Performance Standard for Diagnostic X-Ray Systems and Their Major Components | 0910-AC34 |
| 871 | Establishment and Maintenance of Records Pursuant to the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 | 0910-AC39 |
| 872 | Registration of Food and Animal Feed Facilities | 0910-AC40 |
| 873 | Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 | 0910-AC41 |
| 874 | Presubmission Conferences | 0910-AC44 |
| 875 | Human Subject Protection; Foreign Clinical Studies Not Conducted Under an Investigational New Drug Application | 0910-AF15 |
| 876 | Blood Initiative—Revisions to Labeling and Storage Requirements for Blood and Blood Components, Including Source Plasma | 0910-AF26 |
| 877 | Over-the-Counter (OTC) Drug Review—Antiperspirant Products | 0910-AF30 |
| 878 | Over-the-Counter (OTC) Drug Review—Cough/Cold (Antihistamine) Products | 0910-AF31 |
| 879 | Over-the-Counter (OTC) Drug Review—Ophthalmic Products | 0910-AF39 |
| 880 | Over-the-Counter (OTC) Drug Review—Skin Protectant Products | 0910-AF42 |
| 881 | Over-the-Counter (OTC) Drug Review—Vaginal Contraceptive Products | 0910-AF44 |
| Food and Drug Administration—Long-Term Actions | ||
|---|---|---|
| Sequence Number | Title | Regulation Identifier Number |
| 882 | Requirements Pertaining to Sampling Services and Private Laboratories Used in Connection With Imported Food | 0910-AB96 |
| 883 | Chronic Wasting Disease: Control of Food Products and Cosmetics Derived From Exposed Animal Populations | 0910-AC21 |
| 884 | Requirements for Submission of In Vivo Bioequivalence Data | 0910-AC23 |
| 885 | Toll-Free Number for Reporting Adverse Events on Labeling for Human Drugs | 0910-AC35 |
| 886 | 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 |
| 887 | Submission of Standardized Electronic Study Data From Clinical Studies Evaluating Human Drugs and Biologics | 0910-AC52 |
| 888 | Medical Gas Containers and Closures; Current Good Manufacturing Practice Requirements | 0910-AC53 |
| 889 | Food Labeling: Food Allergen Ingredient Labeling | 0910-AF07 |
| 890 | Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs; Revision of Certain Labeling Controls | 0910-AF08 |
| 891 | Current Good Manufacutring Practices; Quality Control Procedures; Notification Requirements; Records and Reports | 0910-AF27 |
| 892 | Infant Formula Quality Factors | 0910-AF28 |
| 893 | Over-the-Counter (OTC) Drug Review—External Analgesic Products | 0910-AF35 |
| 894 | Over-the-Counter (OTC) Drug Review—Laxative Drug Products | 0910-AF38 |
| 895 | Over-the-Counter (OTC) Drug Review—Oral Health Care Products | 0910-AF40 |
| Food and Drug Administration—Completed Actions | ||
|---|---|---|
| Sequence Number | Title | Regulation Identifier Number |
| 896 | Over-the-Counter (OTC) Drug Review | 0910-AA01 |
| 897 | Infant Formula: Requirements Pertaining to Good Manufacturing Practice, Quality Control Procedures, Quality Factors, Notification Requirements, and Records and Reports | 0910-AA04 |
| 898 | Determination That Informed Consent Is Infeasible or Is Contrary to the Best Interest of Recipients | 0910-AA89 |
| 899 | Blood Initiative | 0910-AB26 |
| 900 | Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products | 0910-AB27 |
| 901 | Supplements and Other Changes to an Approved Application | 0910-AB61 |
| 902 | Current Good Manufacturing Practice for Medicated Feeds | 0910-AB70 |
| 903 | Requirements for Submission of Labeling for Human Prescription Drugs and Biologics in Electronic Format | 0910-AB91 |
| 904 | Use of Materials Derived From Bovine and Ovine Animals in FDA-Regulated Products | 0910-AC19 |
| 905 | Bar Code Label Requirements for Human Drug Products and Blood | 0910-AC26 |
| 906 | Administrative Detention of Food for Human or Animal Consumption Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 | 0910-AC38 |
| 907 | Requirements for Liquid Medicated Feed and Free-Choice Medicated Feed | 0910-AC43 |
| 908 | Biological Products; Bacterial Vaccines and Toxoids; Implementation of Efficacy Review | 0910-AC56 |
| 909 | Revision of the Requirements for Spore-Forming Microorganisms | 0910-A
C57 |
| 910 | Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Human Food (Part 110) (Completion of a Section 610 Review) | 0910-AC58 |
| 911 | Over-the-Counter (OTC) Drug Review—Antidiarrheal Products | 0910-AF29 |
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