TITLE 21-FOOD AND DRUGS Chapter I-Food and Drug Administration, Federal Security Agency.... Part Act (49 Stat. 502; 44 U.S.C. 307) and sections 3 and 4 of the Administrative Procedure Act (60 Stat. 36 Shellfish: definitions and standards of identity; quality; and fill of container. Canned peas and canned beans; definitions and standards of identity; quality Canned vegetables other than those specifically regulated; definitions and 135 Color certification. [Amended] 141 Tests and methods of assay for antibiotic drugs. [Revised] 144 Certification of batches of drugs composed wholly or partly of insulin. 146 Certification of batches of penicillin-containing drugs. [Revised] 155 Sea food inspection. [Amended] 170 Regulations for the enforcement of the Federal Tea Act. [Note] SOURCE: §§ 1.1 to 1.6, inclusive, contained in Regulations, Administrator, Aug. 27, 1946, effective Sept. 11, 1946, 11 F.R. 177A-541. § 1.1 Organization. (a) The Food and Drug Administration, acting under the supervision of the Administrator of the Federal Security Agency, through the Commissioner for Special Services, administers the Federal Food, Drug, and Cosmetic Act (52 Stat. 1040; 21 U.S.C. 301 et seq.), the Federal Tea Act (29 Stat. 604; 21 U.S.C. 41 et seq.), the Federal Caustic Poison Act (44 Stat. 1406; 15 U.S.C. 401 et seq.), the Federal Import Milk Act (44 Stat. 1101; 21 U.S.C. 141 et seq.), and the Federal Filled Milk Act (42 Stat. 1486; 21 U.S.C. 61 et seq.). The central organization of the Food and Drug Administration consists of the Office of the Commissioner of Food and Drugs and the following administrative and technical divisions, the functions of which are indicated by their names: Cosmetic Division. Food Division. Interstate Division. Medical Division. Division of Microbiology. Division of Penicillin Control and Immunology. Division of Pharmacology. Division of State Cooperation. The Office of the Commissioner, the Interstate and Medical Divisions, and the Division of State Cooperation are in the Social Security Building, 4th Street and Independence Avenue, S. W., Washington 25, D. C. The other divisions are in the South Agriculture Building, 12th and C Streets, S. W., Washington 25, D. C. (b) The field organization of the Food and Drug Administration consists of three inspection districts. Each district is divided into several station territories. The district and station headquarters, substations, and inspection posts are as follows: EASTERN DISTRICT: ROOM 1200, U. S. APPRAISER'S Atlanta Station: Room 416, Federal Annex, Charlotte: Federal Building, Charlotte Jacksonville: U. S. Court House Building, Miami: Federal Office Building, Miami Tampa: U. S. Appraiser's Stores, Platt and Water Streets, Tampa 1, Fla. Baltimore Station: Room 800, U. S. Appraiser's Stores, Gay and Lombard Streets, Baltimore 2, Md. Inspection posts: Charleston: State Capitol Building, Norfolk: Brokers Exchange Building, 264 Inspection posts: Portland: U. S. Customs Building, 312 Springfield: Federal Building, Spring- Buffalo Station: Room 415, Federal Building, South Division and Ellicott Streets, Buffalo 3, N. Y. Substation: Pittsburgh: Old Post Office Building, Fourth and Smithfield Streets, Pittsburgh 19, Pa. New York Station: Room 1200, U. S. Appraiser's Stores, 201 Varick Street, New York 14, N. Y. Inspection posts: Newark: Post Office Building, Newark 1, Waterbury: Post Office Building, Water- Philadelphia Station: Room 1204, New Customhouse, Second and Chestnut Streets, Philadelphia 6, Pa. CENTRAL DISTRICT: ROOM 1222, NEW POST OFFICE Chicago Station: Room 1222, New Post Office Detroit: Federal Building, Detroit 26, Milwaukee: Post Office Building, Mil waukee 2, Wis. Cincinnati Station: Room 501, Post Office Cleveland: New Post Office Building, Indianapolis: State Board of Health Nashville: U. S. Customhouse, Nashville Kansas City Station: Room 323, U. S. Courthouse, 811 Grand Avenue, Kansas City 6, Mo. Inspection post: Omaha: Omaha Loan & Building Association Building, 1504 Dodge Street, Omaha 2, Nebr. Minneapolis Station: Room 201, Federal Office Building, Washington and Third Avenue South, Minneapolis 1, Minn. Inspection post: Des Moines: Federal Office Building, Des New Orleans Station: Room 223, U. S. Customhouse, 423 Canal Street, New Orleans 16. La. Substation: Houston: Federal Office Building, Houston 14, Tex. Inspection posts: Birmingham: Post Office Box 1649, Birmingham, Ala. Dallas: Terminal Annex, Dallas 2, Tex. St. Louis Station: Room 1007, New Federal Building, 1114 Market Street, St. Louis 1, Mo. Inspection post: Memphis: U. S. Customhouse, Memphis 1, Tenn. WESTERN DISTRICT: ROOM 512, FEDERAL OFFICE BUILDING, FULTON AND LEAVENWORTH STREETS, SAN FRANCISCO 2, CALIF. Denver Station: Room 531, U. S. Customhouse, Denver 2, Colo. Inspection posts: Albuquerque: Federal Building, Albu- Lubbock: Post Office Building, Lubbock, Salt Lake City: Federal Building, Salt Los Angeles Station: Room 514, California Phoenix: Federal Court Building, Phoe- San Diego: Post Office Box 1321, San San Francisco Station: Room 512, Federal Fresno: Holland Building, 2135 Fresno Sacramento: 2320 K Street, Sacramento, Seattle Station: Room 501, Federal Office Butte: Post Office Box 247, Butte, Mont. Yakima: 301 North Second Street, able cause contemplated by section 304 (a) of the Federal Food, Drug, and Cosmetic Act (21 U. S. C. 334 (a)). (2) To officers of Stations of the Food and Drug Administration, to determine whether articles offered for import are in compliance with the Federal Food, Drug, and Cosmetic Act and the Federal Caustic Poison Act. Decisions by such officers are subject to review successively by the Chief of District, the Commissioner of Food and Drugs, and the Administrator of the Federal Security Agency. (3) To the Commissioner of Food and Drugs and to any other officer or employee of the Food and Drug Administration whom he may designate to act on his behalf for the purpose, to make determinations with respect to disclosure of official records and information in accordance with § 196.1 (c) of this chapter. (b) Final authority of the Commissioner of Food and Drugs is delegated: (1) To Arnold J. Lehman, Bert J. Vos, Jr., and R. Lorimer Grant, to sign on behalf of the Commissioner certificates issued by the Food and Drug Administration for drugs composed wholly or partly of insulin. (2) To G. Robert Clark and Kenneth A. Freeman, to sign on behalf of the Commissioner certificates issued by the Food and Drug Administration for coaltar colors. (3) To Charles W. Crawford, Louis D. Elliott, George P. Larrick, Henry Welch, and Donald C. Grove, to act in behalf of the Commissioner for the purposes of the regulations in Part 146 of this chapter, governing certification of batches of penicillin-containing drugs. (4) To William R. Jester, to sign on behalf of the Commissioner certificates issued by the Food and Drug Administration for drugs composed wholly or partly of penicillin. (5) To C. W. Crawford, L. D. Elliott, and G. P. Larrick, to make determinations with respect to disclosure of official records and information in accordance with 196.1 (c) of this chapter. § 1.3 Obtaining information and making submittals and requests. (a) General information pertaining to the functions of the Food and Drug Administration may be obtained from any of the offices listed in § 1.1. Responses to letters directed to inspection posts are likely to be delayed since inspectors assigned to such posts are frequently absent on official travel. Earlier responses to inquiries concerning the legality of new products or processes or to suggestions involving change in policy are ordinarily obtained by directing such requests and suggestions to the Office of the Commissioner of Food and Drugs. (b) Disclosure of official records and information on investigations by the Food and Drug Administration is subject to the procedure prescribed in § 196.1 of this chapter. (c) The following should be directed to the Administrator of the Federal Security Agency, and mailed to the Commissioner of Food and Drugs: (1) Applications for the issuance, amendment, or repeal of any regulation authorized by any law listed in § 1.1. (2) Applications for new drugs submitted pursuant to section 505 (b) of the Federal Food, Drug, and Cosmetic Act (21 U. S. C. 355 (b)). (3) Applications for permits under the Federal Import Milk Act. of (d) Requests for certification batches of coal-tar colors, drugs composed wholly or partly of insulin, and drugs composed wholly or partly of penicillin should be directed to the Commissioner of Food and Drugs. (e) Applications for the granting of sea food inspection service at establishments packing canned shrimp or canned oysters should be directed to the Atlanta Station or the New Orleans Station. § 1.4 Procedures. (a) Evidence acquired through examinations and investigations by the Food and Drug Administration of violations of any of the acts listed in § 1.1, on which criminal, libel for condemnation, or injunction proceedings are contemplated under the authority of such act, is referred by the Federal Security Administrator to the Department of Justice with recommendation for the institution of such proceedings. (b) Any interested person may propose to the Federal Security Administrator the issuance, amendment, or repeal of any regulation authorized by any law listed in § 1.1. The request should set forth the proposal in general terms and Page 2950 should state reasonable grounds therefor. Procedures on proposals with respect to regulations to which the provisions of sections 507 (f) or 701 (e) of the Federal Food, Drug, and Cosmetic Act (21 U. S. C. 357 (f) and 371 (e)) apply are prescribed in those sections and in the rules of practice for hearings under section 701 (e) (21 CFR, Cum. Supp., 2.701 et seq.). Proposals with respect to regulations under a statute which requires no hearing for such regulations are announced for informal public hearing or for the submission of written comments, unless such proposals are clearly noncontroversial. (c) Procedure governing imports under the Federal Food, Drug, and Cosmetic Act is prescribed by 21 CFR 2.300 et seq.; procedure governing imports under the Federal Caustic Poison Act is prescribed by 21 CFR, Part 175. Consular forms 197 and 198 for use in making shipper's declaration under the Federal Food, Drug, and Cosmetic Act may be obtained from Consular offices. Appeals from decisions under either Act of officers of Stations, referred to in § 1.2 (a) (2), are informal and may be made by letter or in person by the importer or his representative. (d) Procedure governing the filing of applications with respect to new drugs pursuant to section 505 (b) of the Fed-. eral Food, Drug, and Cosmetic Act (21 U.S.C. 355 (b)) is prescribed by 21 CFR, Supps., 2.110. Form FD 356, containing detailed information on material to be submitted as part of an application, should be followed in preparing such applications. Copies of the form may be obtained from the Office of the Commissioner of Food and Drugs, the Medical Division, and the Districts and Stations. Procedure for the conduct of hearings under section 505 (d) and (e) of the act (21 U. S. C. 355 (d) and (e)) is stated in notices of such hearings. (e) Procedure governing the importation of merchandise subject to the Federal Tea Act is prescribed in 21 CFR, and Cum. Supp., Part 170. Form T. I. S. Cat. No. 1 for use in the submission of samples for examination and Form No. T. I. S. Cat. No. 20 entitled "Application for Review by United States Board of Tea Appeals" may be obtained from the Office of the Commissioner of Food and Drugs, the New York and San Francisco Chapter I-Food and Drug Administration Stations, and from any Collector of Customs. (f) Procedure governing the importation of milk and cream under the Federal Import Milk Act is prescribed by 21 CFR, Part 185. Forms I. M. 4, application for permit; I. M. 1, report of tuberculin tests of cattle; I. M. 2, report of physical examination of cows; I. M. 3, certification of authority of examining veterinarians and inspectors; I. M. 5, score card for dairy farms; and I. M. 6, score card for receiving and shipping plants, may be obtained from the Office of the Commissioner of Food and Drugs and from Veterinary Director General, Health of Animals Division, Department of Agriculture, Ottawa, Canada. Canadian shippers may obtain from the Veterinary Director General information as to the Canadian officials who are available to supervise such tests and examinations. (g) Procedure governing the certification of coal-tar colors under the Federal Food, Drug, and Cosmetic Act is prescribed by 21 CFR, Supps., Part 135. Specimen forms for use as guides in preparing requests for certification of batches of straight colors, color mixtures, and repacked colors may be obtained from the Office of the Commissioner of Food and Drugs, the Cosmetic Division, and the Districts and Stations. (h) Procedure for the certification under the Federal Food, Drug, and Cosmetic Act of drugs composed wholly or partly of insulin is prescribed by 21 CFR, Supps., Part 144. Specimen forms for use as guides in preparing requests for approval of master lots, trial dilutions, trial mixtures of protamine zinc insulin or globin insulin with zinc, lots of protamine, and lots of globin hydrochloride, and requests for certification of finished batches of insulin-containing drugs, may be obtained from the Office of the Commissioner of Food and Drugs and the Division of Pharmacology. § 1.4 17------ 18. 19_ 20. Request for Supplemental Certification of a Batch of a Penicillin Drug. Request for Certification of a Batch of Tablets Alum Precipitated Penicillin. Request for Certification of a Request for Certification of a (j) Procedure governing the service of inspection of establishments packing sea food under the Federal Food, Drug, and 1 Revised. Page 2951 |