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 2004 Unified Agenda for the Food and
Drug Administration.
| Food and Drug Administration--Proposed Rule Stage |
Sequence Number |
Title |
Regulation Identification Number |
| 929 |
Foreign and Domestic Establishment Registration and Listing Requirements
for Human Drugs, Certain Biological Drugs, and Animal Drugs (Reg Plan Seq
No. 43) |
0910-AA49 |
| 930 |
Medical Devices; Anesthesiology Devices; Proposed Reclassification
of Pressure Regulators for Use With Medical Oxygen |
0910-AC30 |
| 931 |
Submission of Standardized Electronic Study Data From Clinical
Studies Evaluating Human Drugs and Biologics |
0910-AC52 |
| 932 |
Medical Gas Containers and Closures; Current Good Manufacturing
Practice Requirements |
0910-AC53 |
| 933 |
Food Standards: General Principles and Food Standards Modernization |
0910-AC54 |
| 934 |
Positron Emission Tomography Drugs; Current Good Manufacturing
Practices |
0910-AC55 |
| 935 |
Reporting Information Regarding Falsification of Data |
0910-AC59 |
| 936 |
Health Claims |
0910-AF09 |
| 937 |
Quality Standard Regulation Establishing an Allowable Level
for Arsenic in Bottled Water |
0910-AF10 |
| 938 |
Content and Format of Labeling for Human Prescription Drugs
and Biologics; Requirements for Pregnancy and Lactation |
0910-AF11 |
| 939 |
Cochineal Extract and Carmine Label Declaration |
0910-AF12 |
| 940 |
Charging for Investigational Drugs |
0910-AF13 |
| 941 |
Treatment Use of Investigational Drugs |
0910-AF14 |
| 942 |
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 |
| 943 |
Revocation of the Status of Specific Products; Group A Streptococcus |
0910-AF20 |
| 944 |
Obstetrical and Gynecological Devices; Designation of Special
Control for Condoms and Condoms with Spermicidal Lubricant |
0910-AF21 |
| 945 |
Blood Initiative—Requirements for Human Blood and Blood
Components Intended for Transfusion or for Further Manufacturing Use |
0910-AF25 |
| 946 |
Over-the-Counter (OTC) Drug Review—Cough/Cold (Bronchodilator)
Products |
0910-AF32 |
| 947 |
Over-the-Counter (OTC) Drug Review—Cough/Cold (Combination)
Products |
0910-AF33 |
| 948 |
Over-the-Counter (OTC) Drug Review—Cough/Cold (Nasal
Decongestant) Products |
0910-AF34 |
| 949 |
Over-the-Counter (OTC) Drug Review—Internal Analgesic
Products |
0910-AF36 |
| 950 |
Over-the-Counter (OTC) Drug Review—Labeling of Drug
Products for OTC Human Use |
0910-AF37 |
| 951 |
Over-the-Counter (OTC) Drug Review—Weight Control Products |
0910-AF45 |
| 952 |
Substances Prohibited From Use in Animal Food or Feed (Reg
Plan Seq No. 44) |
0910-AF46 |
| 953 |
Over-the-Counter (OTC) Drug Review—Dandruff, Seborrheic
Dermatitis, and Psoriasis Products |
0910-AF49 |
| 954 |
Over-the-Counter (OTC) Drug Review—Overindulgence in
Food and Drink Products |
0910-AF51 |
| 955 |
Over-the-Counter (OTC) Drug Review—Skin Bleaching Prodcuts |
0910-AF53 |
| 956 |
Use of Materials Derived From Cattle In Human and Animal Medical
Products (Reg
Plan Seq No. 45) |
0910-AF54 |
| 957 |
Requirements for Human and Animal Medical Products Manufactured
From, Processed With, or Otherwise Containing Material From Cattle (Reg
Plan Seq No. 46) |
0910-AF55 |
| Food and Drug Administration--Final Rule Stage |
Sequence Number |
Title |
Regulation Identification Number |
| 958 |
Investigational New Drugs: Export Requirements for Unapproved
New Drug Products |
0910-AA61 |
| 959 |
Requirements on Content and Format of Labeling for Human Prescription
Drugs and Biological Products (Reg
Plan Seq No. 47) |
0910-AA94 |
| 960 |
Safety Reporting Requirements for Human Drug and Biological
Products (Reg
Plan Seq No. 48) |
0910-AA97 |
| 961 |
Current Good Tissue Practice for Human Cell, Tissue, and Cellular
and Tissue-Based Product Establishments; Inspection and Enforcement (Reg
Plan Seq No. 49) |
0910-AB28 |
| 962 |
Applications for FDA Approval To Market a New Drug; Complete
Response Letter; Amendments To Unapproved Applications |
0910-AB34 |
| 963 |
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) (Reg
Plan Seq No. 50) |
0910-AB76 |
| 964 |
Current Good Manufacturing Practice in Manufacturing, Packing,
or Holding Dietary Ingredients and Dietary Supplements (Reg
Plan Seq No. 51) |
0910-AB88 |
| 965 |
Additional Safeguards for Children in Clinical Investigations
of FDA-Regulated Products |
0910-AC07 |
| 966 |
Prevention of Salmonella Enteritidis in Shell Eggs (Reg
Plan Seq No. 52) |
0910-AC14 |
| 967 |
Institutional Review Boards: Registration Requirements |
0910-AC17 |
| 968 |
Medical Devices; Patient Examination and Surgeons' Gloves;
Adulteration |
0910-AC32 |
| 969 |
Amendments to the Performance Standard for Diagnostic X-Ray
Systems and Their Major Components |
0910-AC34 |
| 970 |
Toll-Free Number for Reporting Adverse Events on Labeling
for Human Drugs (Reg
Plan Seq No. 53) |
0910-AC35 |
| 971 |
Establishment and Maintenance of Records Pursuant to the Public
Health Security and Bioterrorism Preparedness and Response Act of 2002 (Reg
Plan Seq No. 54) |
0910-AC39 |
| 972 |
Registration of Food and Animal Feed Facilities (Reg
Plan Seq No. 55) |
0910-AC40 |
| 973 |
Prior Notice of Imported Food Under the Public Health Security
and Bioterrorism Preparedness and Response Act of 2002 (Reg
Plan Seq No. 56) |
0910-AC41 |
| 974 |
Human Subject Protection; Foreign Clinical Studies Not Conducted
Under an Investigational New Drug Application |
0910-AF15 |
| 975 |
Use of Ozone-Depleting Substances: Removal of Essential Use
Designation; Albuterol (Reg
Plan Seq No. 57) |
0910-AF18 |
| 976 |
Blood Initiative—Revisions to Labeling and Storage Requirements
for Blood and Blood Components, Including Source Plasma |
0910-AF26 |
| 977 |
Current Good Manufacturing Practices; Quality Control Procedures;
Notification Requirements; Records and Reports |
0910-AF27 |
| 978 |
Infant Formula Quality Factors |
0910-AF28 |
| 979 |
Over-the-Counter (OTC) Drug Review—Cough/Cold (Antihistamine)
Products |
0910-AF31 |
| 980 |
Over-the-Counter (OTC) Drug Review—Ophthalmic Products |
0910-AF39 |
| 981 |
Over-the-Counter (OTC) Drug Review—Skin Protectant Products |
0910-AF42 |
| 982 |
Over-the-Counter (OTC) Drug Review—Vaginal Contraceptive
Products |
0910-AF44 |
| 983 |
Use of Materials Derived From Cattle in Human Food and Cosmetics (Reg
Plan Seq No. 58) |
0910-AF47 |
| 984 |
Recordkeeping Requirements for Human Food and Cosmetics Manufactured
From, Processed With, or Otherwise Containing Material From Cattle (Reg
Plan Seq No. 59) |
0910-AF48 |
| 985 |
Over-the-Counter (OTC) Drug Review—Antacid Products
(Sodium Bicarbonate Labeling) |
0910-AF52 |
| Food and Drug Administration--Long-Term Actions |
Sequence Number |
Title |
Regulation Identification Number |
| 986 |
Requirements Pertaining to Sampling Services and Private Laboratories
Used in Connection With Imported Food |
0910-AB96 |
| 987 |
Chronic Wasting Disease: Control of Food Products and Cosmetics
Derived From Exposed Animal Populations |
0910-AC21 |
| 988 |
Requirements for Submission of In Vivo Bioequivalence Data |
0910-AC23 |
| 989 |
Exception From General Requirements for Informed Consent;
Request for Comments and Information |
0910-AC25 |
| 990 |
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 |
| 991 |
Food Labeling: Food Allergen Ingredient Labeling |
0910-AF07 |
| 992 |
Current Good Manufacturing Practice in Manufacturing, Processing,
Packing, or Holding of Drugs; Revision of Certain Labeling Controls |
0910-AF08 |
| 993 |
Over-the-Counter (OTC) Drug Review—External Analgesic
Products |
0910-AF35 |
| 994 |
Over-the-Counter (OTC) Drug Review—Laxative Drug Products |
0910-AF38 |
| 995 |
Over-the-Counter (OTC) Drug Review—Oral Health Care
Products |
0910-AF40 |
