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 2005 Unified Agenda for the Food and
Drug Administration.
|
Food and Drug Administration—Proposed Rule Stage |
|---|
Sequence Number |
Title |
Regulation Identifier Number |
| 843 | Foreign and Domestic Establishment Registration and Listing Requirements for Human Drugs, Certain Biological Drugs, and Animal Drugs | 0910-AA49 |
| 844 | Medical Devices; Anesthesiology Devices; Proposed Reclassification of Pressure Regulators for Use With Medical Oxygen | 0910-AC30 |
| 845 | Submission of Standardized Electronic Study Data From Clinical Studies Evaluating Human Drugs and Biologics | 0910-AC52 |
| 846 | Medical Gas Containers and Closures; Current Good Manufacturing Practice Requirements | 0910-AC53 |
| 847 | Food Standards: General Principles and Food Standards Modernization | 0910-AC54 |
| 848 | Positron Emission Tomography Drugs; Current Good Manufacturing Practices | 0910-AC55 |
| 849 | Reporting Information Regarding Falsification of Data | 0910-AC59 |
| 850 | Health Claims | 0910-AF09 |
| 851 | Content and Format of Labeling for Human Prescription Drugs and Biologics; Requirements for Pregnancy and Lactation | 0910-AF11 |
| 852 | Cochineal Extract and Carmine Label Declaration | 0910-AF12 |
| 853 | Charging for Investigational Drugs | 0910-AF13 |
| 854 | Treatment Use of Investigational Drugs | 0910-AF14 |
| 855 | Distribution of Blood Derivatives by Registered Blood Establishments That Qualify as Health Care Entities; PDMA of 1987; PDA of 1992; Policies, Requirements, and Administrative Procedures | 0910-AF16 |
| 856 | Revocation of the Status of Specific Products; Group A Streptococcus | 0910-AF20 |
| 857 | Obstetrical and Gynecological Devices; Designation of Special Control for Condoms and Condoms With Spermicidal Lubricant | 0910-AF21 |
| 858 | Blood Initiative—Requirements for Human Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use | 0910-AF25 |
| 859 | Over-the-Counter (OTC) Drug Review—Cough/Cold (Bronchodilator) Products | 0910-AF32 |
| 860 | Over-the-Counter (OTC) Drug Review—Cough/Cold (Combination) Products | 0910-AF33 |
| 861 | Over-the-Counter (OTC) Drug Review—Cough/Cold (Nasal Decongestant) Products | 0910-AF34 |
| 862 | Over-the-Counter (OTC) Drug Review—Internal Analgesic Products | 0910-AF36 |
| 863 | Over-the-Counter (OTC) Drug Review—Labeling of Drug Products for OTC Human Use | 0910-AF37 |
| 864 | Over-the-Counter (OTC) Drug Review—Ophthalmic Products | 0910-AF39 |
| 865 | Over-the-Counter (OTC) Drug Review—Weight Control Products | 0910-AF45 |
| 866 | Substances Prohibited From Use in Animal Food or Feed | 0910-AF46 |
| 867 | Over-the-Counter (OTC) Drug Review—Dandruff, Seborrheic Dermatitis, and Psoriasis Products | 0910-AF49 |
| 868 | Over-the-Counter (OTC) Drug Review—Skin Bleaching Prodcuts | 0910-AF53 |
| 869 | Over-the-Counter (OTC) Drug Review—Stimulant Drug Products | 0910-AF56 |
| 870 | Designation of New Animal Drugs for Minor Use and Minor Species | 0910-AF60 |
|
Food and Drug Administration—Final Rule Stage |
|---|
Sequence Number |
Title |
Regulation Identifier Number |
| 871 | Requirements on Content and Format of Labeling for Human Prescription Drugs and Biological Products | 0910-AA94 |
| 872 | Safety Reporting Requirements for Human Drug and Biological Products | 0910-AA97 |
| 873 | Applications for FDA Approval To Market a New Drug; Complete Response Letter; Amendments To Unapproved Applications | 0910-AB34 |
| 874 | CGMPs 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 |
| 875 | Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Dietary Ingredients and Dietary Supplements | 0910-AB88 |
| 876 | Requirements Pertaining to Sampling Services and Private Laboratories Used in Connection With Imported Food | 0910-AB96 |
| 877 | Additional Safeguards for Children in Clinical Investigations of FDA-Regulated Products | 0910-AC07 |
| 878 | Prevention of Salmonella Enteritidis in Shell Eggs | 0910-AC14 |
| 879 | Institutional Review Boards: Registration Requirements | 0910-AC17 |
| 880 | Exception From General Requirements for Informed Consent; Request for Comments and Information | 0910-AC25 |
| 881 | Medical Devices; Patient Examination and Surgeons' Gloves; Adulteration | 0910-AC32 |
| 882 | Amendments to the Performance Standard for Diagnostic X-Ray Systems and Their Major Components | 0910-AC34 |
| 883 | Toll-Free Number for Reporting Adverse Events on Labeling for Human Drugs | 0910-AC35 |
| 884 | Registration of Food and Animal Feed Facilities | 0910-AC40 |
| 885 | Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 | 0910-AC41 |
| 886 | Quality Standard Regulation Establishing an Allowable Level for Arsenic in Bottled Water | 0910-AF10 |
| 887 | Human Subject Protection; Foreign Clinical Studies Not Conducted Under an Investigational New Drug Application | 0910-AF15 |
| 888 | Blood Initiative—Revisions to Labeling and Storage Requirements for Blood and Blood Components, Including Source Plasma | 0910-AF26 |
| 889 | Infant Formula: Current Good Manufacturing Practices; Quality Control Procedures; Notification Requirements; Records and Reports | 0910-AF27 |
| 890 | Infant Formula Quality Factors | 0910-AF28 |
| 891 | Over-the-Counter (OTC) Drug Review—Cough/Cold (Antihistamine) Products | 0910-AF31 |
| 892 | Over-the-Counter (OTC) Drug Review—Skin Protectant Products | 0910-AF42 |
| 893 | Over-the-Counter (OTC) Drug Review—Vaginal Contraceptive Products | 0910-AF44 |
| 894 | Use of Materials Derived From Cattle in Human Food and Cosmetics | 0910-AF47 |
| 895 | Recordkeeping Requirements for Human Food and Cosmetics Manufactured From, Processed With, or Otherwise Containing Material From Cattle | 0910-AF48 |
| 896 | Over-the-Counter (OTC) Drug Review—Antacid Products | 0910-AF52 |
| 897 | Supplements and Other Changes to Approved New Animal Drug Applications | 0910-AF59 |
| 898 | Biological Products; Bacterial Vaccines and Toxoids; Implementation of Efficacy Review | 0910-AF62 |
|
Food and Drug Administration—Long-Term Actions |
|---|
Sequence Number |
Title |
Regulation Identifier Number |
| 899 | Investigational New Drugs: Export Requirements for Unapproved New Drug Products | 0910-AA61 |
| 900 | Chronic Wasting Disease: Control of Food Products and Cosmetics Derived From Exposed Animal Populations | 0910-AC21 |
| 901 | Requirements for Submission of In Vivo Bioequivalence Data | 0910-AC23 |
| 902 | 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 |
| 903 | Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs; Revision of Certain Labeling Controls | 0910-AF08 |
| 904 | Over-the-Counter (OTC) Drug Review—External Analgesic Products | 0910-AF35 |
| 905 | Over-the-Counter (OTC) Drug Review—Laxative Drug Products | 0910-AF38 |
| 906 | Over-the-Counter (OTC) Drug Review—Oral Health Care Products | 0910-AF40 |
| 907 | Over-the-Counter (OTC) Drug Review—Overindulgence in Food and Drink Products | 0910-AF51 |
| 908 | Use of Materials Derived From Cattle in Medical Products Intended for Use in Humans and Drugs Intended for Use in Ruminants | 0910-AF54 |
| 909 | Label Requirement for Food That Has Been Refused Admission Into the United States | 0910-AF61 |
