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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: 11/09/2011

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1. AUTHORITY DELEGATED AND TO WHOM DELEGATED

A. The following officials are authorized under §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 and to approve grants for conducting such programs:

1. Center Director, and the Associate Directors for Research, Management, National Center for Toxicological Research (NCTR), Office of the Chief Scientist (OCS)

2. Director and Deputy Directors, Center for Devices and Radiological Health (CDRH), Office of Medical Products and Tobacco (OMPT)

3. Director and Deputy Director, Center for Biologics Evaluation and Research (CBER); Director and Deputy Directors, Office of Compliance and Biologics Quality, CBER, OMPT

4. Director and Deputy Directors, Center for Food Safety and Applied Nutrition (CFSAN), Office of Foods (OF)

5. Director, Deputy Director and Senior Advisor for Science Policy, Center for Veterinary Medicine (CVM), OF

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

7. Associate Commissioner for Special Medical Programs (OSMP), OMPT, and Director, Office of Orphan Products Development (OOPD), OSMP, OMPT

8. Director and Deputy Director, Center for Tobacco Products (CTP), OMPT

9. Associate Commissioner for External Affairs, Office of the Commissioner (OC)

10. Associate Commissioner for International Programs, Office of International Programs, Office of Global Regulatory Operations and Policy

11. Associate Director, Technical Cooperation/Capacity Building, Office of International Programs, Office of Global Regulatory Operations and Policy

12. Director, International Affairs Staff, CFSAN, OF

13. Deputy Director, International Affairs Staff, CFSAN, OF

14. International Policy Manager, International Affairs Staff, CFSAN, OF

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

C. The Chief Operating Officer, Office of Operations (OO); the Director, Office of Acquisitions and Grants Services (OAGS), Office of Finance Budget and Acquisition (OFBA), OO, the Director, Division of Contracts and Grants Management (DCGM), OAGS, OFBA, OO; and the Chief Grants Management Officer and Grants Management Officer, DCGM, OAGS, OFBA, OO 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, OCS is authorized under §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.

E. Under §301 (d) of the PHS Act, the following individuals have the authority to issue Certificates of Confidentiality:

1. Director and Deputy Director of the Office of Compliance, CDER, OMPT

2. Director and Deputy Director of Division of Scientific Investigation, CDER, OMPT

3. Director and Deputy Director of the Office of Compliance & Biologics Quality, CBER, OMPT

4. Director of the Division of Inspections and Surveillance, CBER, OMPT

5. Director and Deputy Directors, CDRH, OMPT

6. Director and Deputy Directors, Office of Device Evaluation (ODE), CDRH, OMPT

7. Director and Deputy Directors, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD), CDRH, OMPT

8. Director and Deputy Director, Office of Compliance (OC), CDRH, OMPT

2. REDELEGATION

The Chief Operating Officer, Office of Operations, may further redelegate the authorities in paragraph C. of this SMG. With the exception of paragraph C. of this section, these officials may not further redelegate these authorities.

3. EFFECTIVE DATE

The Commissioner of Food and Drugs approved this delegation, via memorandum, on November 9, 2011.

STATUS
(I, R, C)
DATE APPROVEDLOCATION
OF CHANGE HISTORY
CONTACTAPPROVING OFFICIAL
Initial 06/23/2009N/aOC/OO
/OM/OMP
Commissioner of Food and Drugs
Revision 06/08/2010N/aOC/OA/
OM/OMP
Margaret A. Hamburg M.D., Commissioner of Food and Drugs
Revision11/09/2011N/aOO/OMMargaret A. Hamburg M.D., Commissioner of Food and Drugs