SMG 1410.26

FDA STAFF MANUAL GUIDES, VOLUME II - DELEGATIONS OF AUTHORITY

REGULATORY - GENERAL REDELEGATIONS OF AUTHORITY

RESEARCH, INVESTIGATION, AND TESTING PROGRAMS AND HEALTH PROMOTION PROGRAMS

Effective Date: 06/23/2009

1. AUTHORITY DELEGATED AND TO WHOM DELEGATED.

A. The following officials are authorized under sections 301, 307, 311, 1701, 1702, 1703, and 1704 of the Public Health Service Act (the PHS Act) (42 U.S.C. 241, 242l, 243, 300u, 300u-1, 300u-2, 300u-3) to establish research, investigation, and testing programs and health information and health promotion programs, which relate to their assigned functions, to approve grants for conducting such programs and to issue Certificates of Confidentiality as described under Section 301 (d) of the PHS Act:

1. The Director, the Deputy Director for Washington Operations, and the Deputy Center Directors, Offices of Research and Management, respectively, National Center for Toxicological Research (NCTR).

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

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

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

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

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

7. The Associate Commissioner for Science, Office of Science and Health Coordination (OSHC), Office of the Commissioner (OC), and the Director, Office of Orphan Products Development (OPD), OSHC, OC.

B. The Director and Deputy Director, CDRH, are authorized to establish an electronic product radiation control program and to approve grants for conducting the program under section 532 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360ii).

C. The Associate Commissioner for Management, Office of Management (OM), OC; the Director, Office of Shared Services (OSS), OM, OC; the Director, Office of Acquisitions and Grants Services (OAGS), OSS, OM, OC, the Director, Division of Contracts and Grants Management (DCGM), OAGS, OSS, OM, OC; and the Chief Grants Management Officer and Grants Management Officer, DCGM, OAGS, OSS, OM, OC are authorized to sign and issue all notices of grant awards and amendments thereto and sign and issue notices of suspension and termination thereof for grants approved under the authority delegated in paragraphs A. and B. of this SMG.

D. The Director, NCTR, is authorized under section 301 of the PHS Act (42 U.S.C. 241), as amended by Public Law 95-622, to make available to educational institutions, for biomedical and behavioral research, laboratory animals bred for research purposes of the Center that are not required to support Center research programs.

2. REDELEGATION.

The Associate Commissioner for Management may further redelegate the authorities in paragraph C. of this SMG. With the exception for paragraph C. of this section, these officials may not further redelegate these authorities.

3. EFFECTIVE DATE.

The Commissioner Food and Drugs approved this delegation of authority on June 23, 2009