§ 5.94 Extensions or stays of effective dates for compliance with certain labeling requirements for human prescription drugs. The following officials are authorized to extend or stay an effective date in § 201.59 of this chapter for compliance with certain labeling requirements for human prescription drugs. (a) For drugs assigned to their organizations: (1) The Director and Deputy Director, Center for Biologics Evaluation and Research (CBER). (2) The Director and Deputy Director, Office of Biological Product Review, CBER. (3) The Directors and Deputy Directors of the divisions in the Office of Biological Product Review, CBER. (b) For drugs assigned to their organizations: (1) The Director and Deputy Director, Center for Drug Evaluation and Research (CDER). (2) The Directors and Deputy Directors of the Office of Drug Evaluation I and Drug Evaluation II, CDER. (3) The Directors and Deputy Directors of the divisions in the Office of Drug Evaluation I and Drug Evaluation II, CDER. [52 FR 2514, Jan. 23, 1987, as amended at 54 FR 8320, Feb. 28, 1989] CENTER FOR DRUG EVALUATION AND RESEARCH 1 Office of Management Division of Management and Budget. Division of Information Systems Design. Division of Drug Information Resources. Medical Library. Office of Epidemiology and Biostatistics Division of Epidemiology and Surveillance. Division of Biometrics. Office of Compliance Division of Drug Labeling Compliance. Division of Scientific Investigations. Office of Drug Evaluation I Division of Cardio-Renal Drug Products. Division of Neuropharmacological Dru Products. Division of Oncology and Radiopharmaceu tical Drug Products. Division of Surgical-Dental Drug Products. Division of Gastrointestinal and Coagula tion Drug Products. Office of Drug Evaluation II Division of Metabolism and Endocrine Dru Products. Division of Anti-Infective Drug Products. Office of Drug Standards Division of OTC Drug Evaluation. Division of Generic Drugs. Division of Bioequivalence. Division of Biopharmaceutics. Division of Drug Advertising and Labeling. Office of Research Resources Division of Research and Testing. CENTER FOR BIOLOGICS EVALUATION AND RESEARCH 2 Office of Management Office of Compliance Office of Biological Product Review Division of Product Quality Control. Division of Biological Investigational New Drugs. Division of Product Certification. 2 Mailing address: 8800 Rockville Pike, Bldg. 29, Bethesda, MD 20814. § 5.110 FDA Public Information Offices. (a) Dockets Management Branch (HFA-305). The Dockets Management Branch Public Room is located in Room 4-62, Parklawn Building, 5600 Fishers Lane, Rockville, MD 20857. Telephone: 301-443-1753. (b) Freedom of Information Staff (HFI-35). The Freedom of Information Public Room is located in Room 12A-30, Parklawn Building, 5600 Fishers Lane, Rockville, MD 20857. Telephone: 301-443-6310. (c) Press Relations Staff (HFI-40). Press Offices are located in Room 1505, Parklawn Building, 5600 Fishers Lane, Rockville, MD 20857. Telephone: 301-443-3285; and in Room 3807, FB-8, 200 C Street SW., Washington, D.C. 20204. Telephone: 202-245-1144. [46 FR 8455, Jan. 27, 1981, as amended at 54 FR 9034, Mar. 3, 1989] "Mailing address: Jefferson, AR 72079. § 5.115 Field structure. NORTHEAST REGION Regional Field Office: 830 Third Av Brooklyn, NY 11232. New York District Office: 850 Third Av Brooklyn, NY 11232. Boston District Office: One Montvale Av Stoneham, MA 02180. Buffalo District Office: 599 Delaware Av Buffalo, NY 14202. MID-ATLANTIC REGION Regional Field Office: 900 U.S. Custor house, Second and Chestnut Sts., Phil delphia, PA 19106. Philadelphia District Office: 900 U.S. Cu tomhouse, Second and Chestnut St. Philadelphia, PA 19106. Baltimore District Office: 900 Madison Ave Baltimore, MD 21201. Cincinnati District Office: 1141 Centr Parkway, Cincinnati, OH 45202-1097. Newark District Office: 61 Main St., We Orange, NJ 07052. SOUTHEAST REGION Regional Field Office: 60 Eighth St. NE., A lanta, GA 30309. Atlanta District Office: 60 Eighth St. NE Atlanta, GA 30309. Nashville District Office: 297 Plus Par New Orleans District Office: 4298 Elysia MIDWEST REGION Regional Field Office: 20 North Michiga Ave., Chicago, IL 60602. Chicago District Office: 1222 PO Bldg., 43 West Van Buren St., Chicago, IL 60607. Detroit District Office: 1560 East Jefferson Detroit, MI 48207. Minneapolis District Office: 240 Hennepi Ave., Minneapolis, MN 55401. SOUTHWEST REGION Regional Field Office: 3032 Bryan St Dallas, TX 75204. Dallas District Office: 3032 Bryan St Dallas, TX 75204. Denver District Office: Bldg. 20, Denve Federal Center, Sixth and Kipling Sts P.O. Box 25087, Denver, CO 80225-0087. Kansas City District Office: 1009 Cherr St., Kansas City, MO 64106. St. Louis Branch: 308 North Collins Alley St. Louis, MO 63102. Subpart A-General Provisions 87.1 Scope. to This part governs the practices and procedures applicable to regulatory enforcement actions initiated by the Food and Drug Administration pursuant to the Federal Food, Drug and Cosmetic Act (21 U.S.C. 301 et seq.) and other laws that it administers. This part also provides guidelines for manufacturers and distributors follow with respect to their voluntary removal or correction of marketed violative products. This part is promulgated to clarify and explain the regulatory practices and procedures of the Food and Drug Administration, enhance public understanding, improve consumer protection, and assure uniform and consistent application of practices and procedures throughout the agency. (Sec. 1 et seq., Pub. L. 717, 52 Stat. 10401059 as amended (21 U.S.C. 301 et seq.); secs. 301, 351, and 361, Pub. L. 410, 58 Stat. 691703 as amended (42 U.S.C. 241, 262, and 264)) [43 FR 26218, June 16, 1978] 87.3 Definitions. (a) "Agency" means the Food and Drug Administration. (b) "Citation" or "cite” means a document and any attachments thereto that provide notice to a person against whom criminal prosecution is contemplated of the opportunity to present views to the agency regarding an alleged violation. (c) "Respondent" means a person named in a notice who presents views concerning an alleged violation either in person, by designated representative, or in writing. (d) "Responsible individual" includes those in positions of power or authority to detect, prevent, or correct violations of the Federal Food, Drug, and Cosmetic Act. (e) [Reserved] (f) "Product" means an article subject to the jurisdiction of the Food and Drug Administration, including any food, drug, and device intended for human or animal use, any cosmetic and biologic intended for human use, and any item subject to a quarantine regulation under Part 1240 of this chapter. "Product" does not include an electronic product that emits radiation and is subject to Parts 1003 and 1004 of this chapter. (g) "Recall" means a firm's removal or correction of a marketed product that the Food and Drug Administration considers to be in violation of the laws it administers and against which the agency would initiate legal action, e.g., seizure. "Recall" does not include a market withdrawal or a stock recovery. (h) "Correction" means repair, modification, adjustment, relabeling, destruction, or inspection (including patient monitoring) of a product without its physical removal to some other location. (i) "Recalling firm" means the firm that initiates a recall or, in the case of a Food and Drug Administration-requested recall, the firm that has primary responsibility for the manufacture and marketing of the product to be recalled. (j) "Market withdrawal" means a firm's removal or correction of a distributed product which involves a minor violation that would not be subject to legal action by the Food and Drug Administration or which involves no violation, e.g., normal stock rotation practices, routine equipment adjustments and repairs, etc. (k) "Stock recovery" means a firm's removal or correction of a product that has not been marketed or that has not left the direct control of the firm, i.e., the product is located on premises owned by, or under the control of, the firm and no portion of the lot has been released for sale or use. "Recall (1) strategy" means a planned specific course of action to be taken in conducting a specific recall, which addresses the depth of recall, need for public warnings, and extent of effectiveness checks for the recall. (m) "Recall classification" means the numerical designation, i.e., I, II, or III, assigned by the Food and Drug Administration to a particular product recall to indicate the relative degree of health hazard presented by the product being recalled. (1) Class I is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death. (2) Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. (3) Class III is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences. (n) "Consignee" means anyone who received, purchased, or used the product being recalled. (Sec. 1 et seq., Pub. L. 717, 52 Stat. 10401059 as amended (21 U.S.C. 301 et seq.); secs. 301, 351, and 361, Pub. L. 410, 58 Stat. 691703 as amended (42 U.S.C. 241, 262, and 264); secs. 305, 701(a) (21 U.S.C. 335, 371(a)) [42 FR 15567, Mar. 22, 1977, as amended at 43 FR 26218, June 16, 1978; 44 FR 12167, Mar. 6, 1979] § 7.12 Guaranty. In case of the giving of a guaranty or undertaking referred to in section 303(c)(2) or (3) of the act, each person signing such guaranty or undertaking shall be considered to have given it. (Sec. 301, 52 Stat. 1042, as amended; 21 U.S.C. 331) § 7.13 Suggested forms of guaranty. (a) A guaranty or undertaking referred to in section 303(c)(2) of the act may be: (1) Limited to a specific shipment or other delivery of an article, in which case it may be a part of or attached to the invoice or bill of sale covering such shipment or delivery, or (2) General and continuing, in which case, in its application to any shipment or other delivery of an article, it shall be considered to have been given at the date such article was shipped or delivered by the person who gives the guaranty or undertaking. (b) The following are suggested forms of guaranty or undertaking under section 303(c)(2) of the act: (1) Limited form for use on invoice or bill of sale. (Name of person giving the guaranty or undertaking) hereby guarantees that no ar |