SMG 1410.29

FDA STAFF MANUAL GUIDES, VOLUME II - DELEGATIONS OF AUTHORITY

REGULATORY - GENERAL REDELEGATIONS OF AUTHORITY

HEARINGS

Effective Date: 02/24/2009

1. AUTHORITY DELEGATED AND TO WHOM DELEGATED

A. The following officials are authorized to designate officials to hold informal hearings that relate to their assigned functions under sections 305, 404(b), and 801(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 335, 344(b), and 381(a)); section 6 of the Fair Packaging and Labeling Act (15 U.S.C. 1455) (21 U.S.C. 145); section 9(b) of the Federal Caustic Poison Act (44 Stat. 1406; see also Public Law 86-613, section 19 formerly section 18); and section 5 of the Federal Import Milk Act. Officials so designated are delegated authority vested in the Secretary of Agriculture by 7 U.S.C. 2217 (43 Stat. 803) to administer to or to take from any person an oath, affirmation, affidavit, or deposition for use in any prosecution or proceeding under, or in enforcement of, any law as cited in 21 CFR or this SMG:

1. The Director and Deputy Director, Center for Food Safety and Applied Nutrition (CFSAN); and the Director of Regulations and Policy, CFSAN.

2. The Director and Deputy Director, the Directors, Office of New Drugs and Office of Pharmaceutical Science, Center for Drug Evaluation and Research (CDER); the Associate Director for Policy and the Associate Director for Medical Policy, CDER; the Directors of the Offices of Drug Evaluation I, II, III, Office of Antimicrobial Products (OAP), Office of Nonprescription Products and Office of Oncology Drug Products (OODP), Office of New Drugs, CDER; and the Director and Deputy Director, Office of Compliance, CDER.

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

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

5. The Director and Deputy Directors, Center for Biologics Evaluation and Research (CBER), and the Directors and Deputy Directors, Office of Blood Research and Review, Office of Vaccines Research and Review, Office of Cellular, Tissue and Gene Therapies, and Office of Compliance and Biologics Quality, CBER.

6. The Director, Office of Enforcement (OE), Office of Regulatory Affairs (ORA) and the Director of Compliance, OE, ORA.

7. Regional Food and Drug Directors.

8. District Directors.

9. The Director, St. Louis Branch.

10. Regional Laboratory Directors.

B. The Director and Deputy Director, CDRH, are authorized to hold hearings, and to designate other officials to hold informal hearings, under section 360(a) of the PHS Act.

C. The following officials are authorized to serve as the presiding officer, and to designate other Food and Drug Administration employees to serve as the presiding officer, at a regulatory hearing and to conduct such a hearing under the provisions of 21 CFR part 16. An official can serve as the presiding officer in a particular hearing only if he or she satisfies the requirements of 21 CFR, Part 16, Sec. 16.42(b) with respect to the action that is the subject of the hearing. Such officials are delegated authority vested in the Secretary of Agriculture by 7 U.S.C. 2217 (43 Stat. 803) to administer or to take from any person an oath, affirmation, or deposition for use in any prosecution or proceeding under, or in enforcement of, any law as cited in this SMG:

1. The Chief Mediator and Ombudsman, Office of the Ombudsman, Office of External Relations, Office of the Commissioner.

2. The Director and Deputy Director, CFSAN.

3. The Director and Deputy Director, Center for Drug Evaluation and Research (CDER); the Directors, Office of New Drugs and Office of Pharmaceutical Science, CDER; the Associate Director for Policy and the Associate Director for Medical Policy, CDER, the Directors of the Offices of Drug Evaluation I, II, III, Office of Antimicrobial Products (OAP), Office of Nonprescription Products and Office of Oncology Drug Products (OODP), Office of New Drugs, CDER; and the Director and Deputy Director, Office of Compliance, CDER.

4. The Director and Deputy Director, CDRH.

5. The Director and Deputy Director, CVM.

6. The Director and Deputy Directors, Center for Biologics Evaluation and Research (CBER), and the Directors and Deputy Directors, Office of Blood Research and Review, Office of Vaccines Research and Review, Office of Cellular, Tissue and Gene Therapies, and Office of Compliance and Biologics Quality, CBER.

7. The Director, Office of Enforcement (OE), Office of Regulatory Affairs (ORA) and the Director of Compliance, OE, ORA.

8. Regional Food and Drug Directors.

9. District Directors.

10. The Director, St. Louis Branch.

11. Regional Laboratory Directors.

12. The Director, Good Clinical Practice Program.

13. Such other FDA official as is designated by the Commissioner by memorandum in the proceeding.

2. REDELEGATION

These officials may not further redelegate these authorities.

3. EFFECTIVE DATE

The Commissioner of Food and Drugs approved this delegation, via memorandum, on February 24, 2009.