cal Health (CDRH), are authorized to perform all functions of the Commissioner of Food and Drugs relating to notification of defects in, noncompliance of, and repair or replacement of or refund for, electronic products under section 359 of the Public Health Service Act (the act) and under §§ 1003.11, 1003.22, 1003.31, 1004.2, 1004.3, 1004.4, and 1004.6 of this chapter; and Regional Food and Drug Directors, District Directors, and the Director, St. Louis Branch, are authorized to perform all such functions relating to: (1) Assemblers of diagnostic x-ray systems, as defined in § 1020.30(b) of this chapter. (2) Manufacturers of sunlamp products and ultraviolet lamps intended for use in any sunlamp product, as defined in § 1040.20(b) of this chapter. (b) The Director and Deputy Director, Office of Compliance, CDRH, are authorized to notify manufacturers of defects in, and noncompliance of, electronic products under section 359(e) of the act and under § 1003.11(a) of this chapter; and the chiefs of District Compliance Branches are authorized to perform all such functions relating to: (1) Assemblers of diagnostic x-reay systems, as defined in § 1020.30(b) of this chapter. (2) Manufacturers of sunlamp products and ultraviolet lamps intended for use in any sunlamp products, as defined in § 1040.20(b) of this chapter. [48 FR 56948, Dec. 27, 1983, as amended at 51 FR 32452, Sept. 12, 1986] § 5.90 Manufacturers requirement to provide data to ultimate purchasers of electronic products. The Director and Deputy Director, Center for Devices and Radiological Health, are authorized to require manufacturers to provide performance and technical data to the ultimate purchaser of electronic products under section 360A(c) of the Public Health Service Act. [48 FR 56948, Dec. 27, 1983] § 5.91 Dealer and distributor direction to provide data to manufacturers of electronic products. The Director and Deputy Director, Center for Devices and Radiological Health (CDRH), the Director and Deputy Director, Office of Compliance, CDRH, are authorized to direct dealers and distributors of electronic products to furnish information on first purchasers of such products to the manufacturer of the product under section 360A(f) of the Public Health Service Act. [48 FR 56948, Dec. 27, 1983] § 5.92 Acceptance of assistance from State and local authorities for enforcement of radiation control legislation and regulations. The Director and Deputy Director, Center for Devices and Radiological Health, are authorized to accept assistance from State and local authorities engaged in activities related to health or safety or consumer protection on a reimbursable basis or otherwise, under section 360E of the Public Health Service Act. [48 FR 56949, Dec. 27, 1983] § 5.93 Submission of and effective approval dates for abbreviated new drug applications and certain new drug applications. The following officials are authorized to perform all of the functions of the Commissioner of Food and Drugs with regard to decisions made under section 505(c)(3)(D), (j)(4)(B)(iv), and (j)(4)(D) of the Federal Food, Drug and Cosmetic Act (the act) concerning the date of submission or the date or effective approval of abbreviated new drug applications including supplements thereto submitted under section 505(j) of the act and of new drug applications including supplements thereto submitted under section 505(b)(1) of the act and described under section 505(b)(2) of the act: (a) The Director and Deputy Director, Center for Drug Evaluation and Research (CDER). (b) The Director and Deputy Director, Office of Drug Standards, CDER. [53 FR 18274, May 23, 1988] § 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. 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 Drug Products. Division of Oncology and Radiopharmaceutical Drug Products. Division of Surgical-Dental Drug Products. Division of Gastrointestinal and Coagulation Drug Products. Office of Drug Evaluation II Division of Metabolism and Endocrine Drug 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 Product Certification. 2 Mailing address: 8800 Rockville Pike, Bldg. 29, Bethesda, MD 20814. 8 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 Ave., Brooklyn, NY 11232. New York District Office: 850 Third Ave., Brooklyn, NY 11232. Boston District Office: One Montvale Ave., Stoneham, MA 02180. Buffalo District Office: 599 Delaware Ave., Buffalo, NY 14202. MID-ATLANTIC REGION Regional Field Office: 900 U.S. Customhouse, Second and Chestnut Sts., Philadelphia, PA 19106. Philadelphia District Office: 900 U.S. Customhouse, Second and Chestnut Sts., Philadelphia, PA 19106. Baltimore District Office: 900 Madison Ave., Baltimore, MD 21201. Cincinnati District Office: 1141 Central Parkway, Cincinnati, OH 45202-1097. Newark District Office: 61 Main St., West Orange, NJ 07052. SOUTHEAST REGION Regional Field Office: 60 Eighth St. NE., Atlanta, GA 30309. Atlanta District Office: 60 Eighth St. NE., Atlanta, GA 30309. Nashville District Office: 297 Plus Park New Orleans District Office: 4298 Elysian MIDWEST REGION Regional Field Office: 20 North Michigan Ave., Chicago, IL 60602. Chicago District Office: 1222 PO Bldg., 433 West Van Buren St., Chicago, IL 60607. Detroit District Office: 1560 East Jefferson, Detroit, MI 48207. Minneapolis District Office: 240 Hennepin 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, Denver Federal Center, Sixth and Kipling Sts., P.O. Box 25087, Denver, CO 80225-0087. Kansas City District Office: 1009 Cherry 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] § 7.3 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 |