SMG 1410.34

FDA STAFF MANUAL GUIDES, VOLUME II - DELEGATIONS OF AUTHORITY

REGULATORY - GENERAL REDELEGATIONS OF AUTHORITY

ISSUANCE OF REPORTS OF MINOR VIOLATIONS

Effective Date: 04/10/2009

1. AUTHORITIES DELEGATED AND TO WHOM DELEGATED.

A. The following officials are authorized to perform all the functions of the Commissioner of Food and Drugs (Commissioner) under section 309 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 336) (the act) regarding the issuance of written notices or warnings:

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

b. The Director and Deputy Directors, Office of Compliance and Biologics Quality, CBER.

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

b. The Director and Deputy Director, Office of Compliance, CDRH.

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

d. 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.a. The Director and Deputy Director, Center for Food Safety and Applied Nutrition, (CFSAN).

b. The Director of Regulations and Policy, CFSAN.

c. The Director, Office of Field Programs, CFSAN.

d. The Director, Division of Enforcement and Programs, Office of Field Programs, CFSAN.

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

b. The Director and Deputy Director, Office of Surveillance and Compliance, CVM.

c. The Director, Division of Compliance, Office of Surveillance and Compliance, CVM.

d. The Director, Division of Surveillance, Office of Surveillance and Compliance, CVM.

5.a. The Director, the Deputy Director, the Associate Director for Policy, and the Directors, Office of New Drugs and Office of Pharmaceutical Science, Center for Drug Evaluation and Research (CDER).

b. The Director and Deputy Director, Office of Compliance, CDER.

c. The Associate Director for Medical Policy, CDER.

d. The Director, Division of Drug Marketing, Advertising, and Communications, Office of Medical Policy, CDER.

6.a. Regional Food and Drug Directors.

b. District Directors.

c. Chiefs of District Compliance Branches.

d. The Director, St. Louis Branch.

e. The Director, Northeast Regional Laboratory, Northeast Region.

f. The Director, Southeast Regional Laboratory, Southeast Region.

g. The Director, Winchester Engineering and Analytical Center.

h. The Director, National Forensic Chemistry Center.

i. The Director, Arkansas Regional Laboratory.

B. The following officials are authorized to perform all the functions of the Commissioner under section 539(d) of the act (21 U.S.C. 360pp(d)) regarding the issuance of written notices or warnings:

1. The Director and Deputy Director, 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, Office of Surveillance and Biometrics (OSB), CDRH, and the Director and Deputy Director, Division of Surveillance Systems (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; the Director, National Forensic Chemistry Center, and the Director, Arkansas Regional Laboratory when such functions relate to:

a. Assemblers of diagnostic x-ray systems, as defined in 21 CFR 1020.30(b); and

b. Manufacturers of sunlamp products and ultraviolet lamps intended for use in any sunlamp product as defined in 21 CFR 1040.20(b).

2. REDELEGATION.

These officials may not further redelegate these authorities.

3. EFFECTIVE DATE.

The Commissioner of Food and Drugs approved this delegation on April 10, 2009.