§ 5.37 - Issuance of reports of minor violations.

(a) The following officials are authorized to perform all the functions of the Commissioner of Food and Drugs under section 309 of the Federal Food, Drug, and Cosmetic Act regarding the issuance of written notices or warnings:

(1)(i) The Director and Deputy Director, Center for Biologics Evaluation and Research (CBER).

(ii) The Director and Deputy Director, Office of Compliance, CBER.

(2)(i) The Director and Deputy Directors, Center for Devices and Radiological Health (CDRH).

(ii) The Director and Deputy Director, Office of Compliance, CDRH.

(iii) For medical devices assigned to their respective divisions, the Division Directors, Office of Compliance, CDRH.

(iv) The Director and Deputy Director, Office of Surveillance and Biometrics (OSB), CDRH, and the Director and Deputy Director, Division of Surveillance Systems (DSS), OSB, CDRH.

(3)(i) The Director and Deputy Directors, Center for Food Safety and Applied Nutrition, (CFSAN).

(ii) The Director, Office of Policy, Planning, and Strategic Initiatives, CFSAN.

(iii) The Director, Office of Field Programs, CFSAN.

(iv) The Director, Division of Enforcement, Office of Field Programs, CFSAN.

(4)(i) The Director and Deputy Director, Center for Veterinary Medicine (CVM).

(ii) The Director and Deputy Director, Office of Surveillance and Compliance, CVM.

(iii) The Director, Division of Compliance, Office of Surveillance and Compliance, CVM.

(5)(i) The Director, Deputy Center Director for Review Management, and Deputy Center Director for Pharmaceutical Science, Center for Drug Evaluation and Research (CDER).

(ii) The Director and Deputy Director, Office of Compliance, CDER.

(iii) The Associate Director for Medical Policy, CDER.

(iv) The Director, Division of Drug Marketing, Advertising, and Communications, Office of Drug Evaluation I, Office of Review Management, CDER.

(6)(i) Regional Food and Drug Directors.

(ii) District Directors.

(iii) Chiefs of District Compliance Branches.

(iv) The Director, St. Louis Branch.

(v) The Director, Northeast Regional Laboratory, Northeast Region.

(vi) The Director, Southeast Regional Laboratory, Southeast Region.

(vii) The Director, Winchester Engineering and Analytical Center.

(viii) The Director, National Forensic Chemistry Center.

(b) The following officials are authorized to perform all the functions of the Commissioner of Food and Drugs under section 539(d) of the Federal Food, Drug, and Cosmetic Act regarding the issuance of written notices or warnings:

(1) The Director and Deputy Directors, Center for Devices and Radiological Health (CDRH).

(2) The Director and Deputy Director, Office of Compliance, CDRH.

(3) For medical devices assigned to their respective divisions, the Division Directors, Office of Compliance, CDRH.

(4) The Director and Deputy Director, OSB, CDRH, and the Director and Deputy Director, DSS, OSB, CDRH.

(5) Regional Food and Drug Directors; District Directors; the Director, St. Louis Branch; the Director, Northeast Regional Laboratory, Northeast Region; the Director, Southeast Regional Laboratory, Southeast Region; the Director, Winchester Engineering and Analytical Center; and the Director, National Forensic Chemistry Center, when such functions relate to:

(i) Assemblers of diagnostic x-ray systems, as defined in § 1020.30(b) of this chapter; and

(ii) Manufacturers of sunlamp products and ultraviolet lamps intended for use in any sunlamp product as defined in § 1040.20(b) of this chapter.