Division of Oncology Drug Products. Division of Metabolic and Endocrine Division of Pulmonary and Allergy Drug Products. Division of Anesthetic, Critical Care and Addiction Drug Products. Office of Drug Evaluation III.1 Division of Gastrointestinal and Coagulation Drug Products. Division of Medical Imaging and Radiopharmaceutical Drug Products. Division of Reproductive and Urologic Drug Products. Office of Drug Evaluation IV.1 Division of Anti-Infective Drug Products. Division of Anti-Viral Drug Products. Division of Anti-Inflammatory, Analgesic and Opthalmologic Drug Products. Division of Dermatologic and Dental Drug Products. Division of Over-The-Counter Drug Products. Office of Biostatistics.1 Quantitative Methods Research Staff. Division of Biometrics I. Division of Biometrics II. Division of Biometrics III. Office of Post-Marketing Drug Risk Assessment.1 Extramural Programs Staff. Information Technology Staff. Division of Drug Risk Evaluation I. Office of Pharmaceutical Science.1 Division of Pharmaceutical Evaluation Office of Generic Drugs.6 Division of Chemistry II. Division of Labeling and Program Support. Office of New Drug Chemistry.1 Laboratory of Clinical Pharmacology.1 Division of Applied Pharmacology Research.7 Division of Pharmaceutical Analysis.8 Division of Planning, Evaluation, and Division of Information Systems. Division of Human Resource Development. Division of Management Operations. Office of Enforcement. Division of Compliance Management and Operations. Division of Compliance Policy. Division of Compliance Information and Quality Assurance. Office of Regional Operations. 7 Mailing address: 8301 Muirkirk Rd., Laurel, MD 20708. 8 Mailing address: 1114 Market St., St. Louis, MO 63101. Division of Federal-State Relations. Division of Emergency and Investigational Operations. Division of Import Operations and Policy. Office of Criminal Investigations. Mid-Atlantic Area Office.9 Midwest Area Office. 10 Northeast Area Office.11 Pacific Area Office.12 Southeast Area Office.13 Southwest Area Office.14 CENTER FOR VETERINARY MEDICINE.15 Office of Management and Communications. Administrative Staff. Information Resources Management Office of New Animal Drug Evaluation. Division of Therapeutic Drugs for Food Animals. Division of Biometics and Production Drugs Division of Therapeutic Drugs for Nonfood Animals. Division of Manufacturing Technologies. Division of Human Food Safety. Office of Surveillance and Compliance. Division of Animal Feeds. Division of Compliance. Division of Epidemiology. Division of Residue Chemistry. 9 Mailing address: 900 U.S. Customhouse, Second Chestnut St., Philadelphia, PA 19106. 10 Mailing address: 901 Warrenville Rd., suite 360, Lisle, IL 60532. 11 Mailing address: 158-15 Liberty Ave., Jamaica, NY 11433. 12 Mailing address: 13301 Clay St., Oakland CA 94512. 13 Mailing address: 60 Eighth St. NE, Atlanta, GA 30309. 14 Mailing address: 7920 Elmbrook Rd., Dallas, TX 75247. 15 Mailing address: 7500 Standish Pl., MPN2, Rockville, MD 20855. Division of Ophthalmic, Ear, Nose, and Throat Devices. Division of Dental, Infection Control, and General Hospital Devices. Office of Science and Technology. Division of Mechanics and Materials Science. Division of Life Sciences. Division of Physical Sciences. Division of Electronics and Computer Sciences. Division of Management Information and Support Services. Office of Health and Industry Programs. 16 Mailing address: 9200 Corporate Blvd., Rockville, MD 20850. Program Operations Staff. Regulations Staff. Staff College. Division of Device User Programs and Systems Analysis. Division of Small Manufacturers Assistance. Division of Mammography Quality and Division of Communication Media. Division of Postmarket Surveillance. Office of the Center Director. Environmental Health and Program Assurance Staff. Office of Research. Technology Advancement Staff. Division of Biochemical Toxicology. Division of Genetic and Reproductive Toxicology. Division of Biometry and Risk Assessment. Division of Microbiology. Division of Chemistry. Division of Neurotoxicology. Division of Veterinary Services. Division of Molecular Epidemiology. Office of Management. Office of Management Services. Division of Facilities, Engineering and Maintenance. Division of Administrative Services. Division of Contracts and Acquisitions. Office of Planning, Finance and Information Technology. Division of Planning. Division of Financial Management. [66 FR 30993, June 8, 2001, as amended at 66 FR 56035, Nov. 6, 2001] 17 Mailing address: 3900 NCTR Dr., Jefferson, AR 72079. § 5.1105 Chief Counsel, Food and Drug Administration. The Office of the Chief Counsel's mailing address is 5600 Fishers Lane, rm. 6-57, Rockville, MD 20857. § 5.1110 Food and Drug Administration Public Information Offices. (a) Dockets Management Branch (HFA– 305). The Dockets Management Branch Public Room is located in rm. 1061, 5630 Fishers Lane, Rockville, MD 20852. Telephone: 301-827-6860. (b) Freedom of Information Staff (HFI35). The Freedom of Information Public Room is located in rm. 12A-30, Parklawn Bldg., 5600 Fishers Lane, Rockville, MD 20857. Telephone: 301-827-6567. (c) Press Relations Staff (HFI-40). Press Offices are located in rm. 15-05, Parklawn Bldg, 5600 Fishers Lane, Rockville, MD 20857. Telephone: 301827-6242; and in rm. 3807, FB-8, 5100 Paint Branch Pkwy., College Park, MD 20740. Telephone 202-205-4144. [66 FR 30993, June 8, 2001, as amended at 66 FR 56035, Nov. 6, 2001] § 5.1115 Field structure. NORTHEAST REGION Regional Field Office: 158-15 Liberty Ave., Jamaica, NY 11433. Northeast Regional Laboratory: 158–15 Liberty Ave., Jamaica, NY 11433. New York District Office: 158-15 Liberty Ave., Jamaica, NY 11433. New England District Office: One Montvale Ave., Stoneham, MA 02180. Winchester Engineering and Analytical Center: 109 Holton St., Winchester, MA 01890 CENTRAL REGION Regional Field Office: U.S. Customhouse, Second and Chestnut Sts., rm. 900, Philadelphia, PA 19106. Philadelphia District Office: U.S. Customhouse, Second and Chestnut Sts., rm. 900, Philadelphia, PA 19106. Baltimore District Office: 900 Madison Ave., Baltimore, MD 21201-2199. Cincinnati District Office: 6751 Steger Dr., Cincinnati, OH 45237-3097. Forensic Chemistry Center: 6751 Steger Dr., Cincinnati, OH 45237-3097. Regional Field Office: 7920 Elmwood Rd., suite 102, Dallas, TX 75247-4982. Dallas District Office: 3310 Live Oak St., Dallas, TX 75204. Denver District Office: Bldg. 20, Denver Federal Center, Sixth and Kipling Sts., P.O. Box 25087, Denver, CO 80225-0087. Kansas City District Office: 11630 West 80th St., Lenexa, KS 66214-3338. St. Louis Branch: 12 Sunnen Dr., suite 122, St. Louis, MO 63143-3800. Arkansas Regional Laboratory: NCTR Rd., Bldg. 14–T, rm. 104, Jefferson, AR 72079-9502. PACIFIC REGION 3900 Regional Field Office: 1301 Clay St., suite 1180-N, Oakland, CA 94612-5217. San Francisco District Office: 1431 Harbor Bay Pkwy., Alameda, CA 94502-7070. Los Angeles District Office: 19900 Mac Arthur Blvd., suite 300, Irvine, CA 92715. Seattle District Office: P.O. Box 3012, Bothell, WA 98021-3012. Subpart D [Reserved] Subpart E-Criminal Violations 7.84 Opportunity for presentation of views before report of criminal violation. 7.85 Conduct of a presentation of views before report of criminal violation. 7.87 Records related to opportunities for presentation of views conducted before report of criminal violation. AUTHORITY: 21 U.S.C. 321-393; 42 U.S.C. 241, 262, 263b-263n, 264. SOURCE: 42 FR 15567, Mar. 22, 1977, unless otherwise noted. Subpart A-General Provisions §7.1 Scope. 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 guidance for manufacturers and distributors to follow (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. (1) Recall 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 serious adverse health consequences or death. cause (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. |