SMG 1410.23

FDA STAFF MANUAL GUIDES, VOLUME II - DELEGATIONS OF AUTHORITY

REGULATORY - GENERAL REDELEGATIONS OF AUTHORITY

CERTIFICATION OF TRUE COPIES AND USE OF DEPARTMENT SEAL

Effective Date: 04/10/2009

1. AUTHORITY DELEGATED AND TO WHOM DELEGATED.

A. The following officials are authorized to certify true copies of or extracts from any books, records, papers, or other documents on file within the Food and Drug Administration, to certify that copies are true copies of the entire file, to certify the complete original record, or to certify the nonexistence of records on file within the Food and Drug Administration, and to cause the seal of the Department to be affixed to such certifications:

1. The Deputy Commissioner, Deputy Commissioner for Policy, Deputy Commissioner for Operations, and Deputy Commissioner for International and Special Programs,

2. The Associate Commissioners and Deputy Associate Commissioners, the Assistant Commissioners and Deputy Assistant Commissioners, and the Chief Counsel and Deputy Chief Counsels.

3. The Director, Office of the Executive Secretariat, Office of External Relations, Office of the Commissioner (OC).

4. The Director, Office of Executive Operations, Office of Management ( OM), OC.

5.a. The Director, Office of Enforcement, Office of Regulatory Affairs (ORA), Director of Compliance, OE, ORA, and Director, Division of Compliance Policy, OE, ORA.

b. The Director and Deputy Director, Office of Regional Operations, ORA.

c. The Director and Deputy Director, Office of Resource Management (ORM), ORA.

d. The Director, Division of Management Operations, ORM, ORA.

e. Team Leader, FDA History Staff, ORM, ORA.

6.a. The Director, Office Management Programs (OMP), OM, OC.

b. The Director, Division of Dockets Management, OMP, OC.

c. The Director, Division of Freedom of Information, OMP, OC.

7. The Assistant Commissioner for Public Affairs, Office of Public Affairs (OPA), Office of External Relations (OER), OC.

8.a. The Chief Information Officer, Office of the Chief Information Officer (OCIO), OM, OC.

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

b. The Director, Office of Management, CBER.

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

d. The Director and Deputy Director, Office of Communication, Training, and Manufacturer's Assistance, CBER.

e. The Director and Branch Chiefs, Division of Case Management, Office of Compliance and Biologics Quality (OCBQ), CBER; and the Consumer Safety Officers, OCBQ, CBER.

10.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 Management Systems, CFSAN.

d. The Director, Office of Cosmetics and Colors, CFSAN.

e. The Director, Office of Plant and Dairy Foods, CFSAN.

f. The Director, Office of Seafood, CFSAN.

g. The Director, Office of Nutritional Products, Labeling, and Dietary Supplements, CFSAN.

h. The Director, Office of Special Research Skills, CFSAN.

i. The Director, Office of Constituent Operations, CFSAN.

j. The Director, Office of Compliance, CFSAN.

k. Director and Deputy Director, Office of Food Additive Safety, CFSAN.

l. The Director, Office of Scientific Analysis and Support, CFSAN.

m. The Director, Office of Science, CFSAN.

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

b. The Associate Director and Deputy Associate Director for Management and Systems, CDRH.

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

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

e. 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.

f. The Director, Office of Systems and Management, CDRH.

g. Freedom of Information Officers, CDRH.

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

b. The Associate Director of Executive Operations, CVM.

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

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

13.a. The Director and Deputy Director for Washington Operations, National Center for Toxicological Research (NCTR).

b. The Deputy Center Director, Office of Management (OM), NCTR, and the Associate Director, Office of Management Services, OM, NCTR.

c. The Deputy Center Director, Office of Research, NCTR.

14.a. The Director and Deputy Director, the Directors, Office of New Drugs, Office of Pharmaceutical Science, Office of Translational Sciences, and Office of Counter-Terrorism and Emergency Coordination; the Associate Director for Policy, and the Associate Director for Medical Policy, Center for Drug Evaluation and Research (CDER).

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

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

d. The Directors and Deputy Directors of the Offices of Drug Evaluation I, II, III, Office of Antimicrobial Products (OAP), Office of Nonprescription Products (ONP) and Office of Oncology Drug Products (OODP), OND, CDER.

e. The Directors and Deputy Directors of the Offices of Testing and Research, Generic Drugs, New Drug Quality Assessment, and Biotechnology Products, Office of Pharmaceutical Science; and the Directors and Deputy Directors of the Office of Biostatistics and Office of Clinical Pharmacology, Office of Translational Sciences, CDER.

f. The Director, Office of Training and Communications (OTCOM), and the Director, Division of Information Disclosure Policy, Office of Regulatory Policy, CDER.

g. The Directors of the Divisions of New Drugs and Labeling Compliance, Manufacturing and Product Quality, and Compliance Risk Management and Surveillance, Office of Compliance, CDER.

15.a. Regional Food and Drug Directors.

b. District Directors.

c. The Director, St. Louis Branch.

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

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

f. The Director, National Forensic Chemistry Center.

g. The Director, Arkansas Regional Laboratory.

h. The Director, Winchester Engineering Analytical Center.

B. The following officials are authorized to cause the seal of the Department to be affixed to agreements, awards, citations, diplomas, and similar documents:

1. The Deputy Commissioner, Deputy Commissioner for Policy, Deputy Commissioner for Operations, and Deputy Commissioner for International and Special Programs.

2. The Associate Commissioners and Deputy Associate Commissioners; the Assistant Commissioners and Deputy Assistant Commissioners; and the Chief Counsel and Deputies.

3. The Director and Deputy Directors, CBER; the Director and Deputy Director, CFSAN; the Director and Deputy Director, CDRH; the Director and Deputy Director, CVM; the Director and Deputy Directors, CDER; and the Director, NCTR, the Deputy Director for Washington Operations, NCTR, and the Deputy Center Directors, Offices of Management and Research, respectively, NCTR.

4. The Director, Office of Executive Operations, OM, OC; Director, Office of Management, CBER; Director, Office of Management, CDER; Director, Office of Management Systems, CFSAN; Director, Office of Systems and Management, CDRH; Director, Office of Management, CVM; Associate Director, Office of Management Services, NCTR; and the Director, Office of Resource Management, ORA.

5. The Director, Office Management Programs, OM, OC.

C. The Chief, Regulations Editorial Section (RES), Regulations Policy and Management Staff (RPMS), Office of Policy and Planning (OPP), OC, and his or her alternates are authorized to certify true copies of Federal Register documents.

2. REDELEGATION STATEMENTS.

A. The following officials may further redelegate the authorities under paragraphs 1.A. and 1.B. of this SMG: the Deputy Commissioner; the Senior Associate Commissioner; the Deputy Commissioner for International and Constituent Relations; the Senior Associate Commissioner for Management and Systems; the Senior Associate Commissioner for Policy, Planning and Legislation; the Associate and Deputy Associate Commissioners; the Chief Counsel and Deputy Chief Counsels; the Directors and Deputy Directors for CBER, CFSAN, CDRH, CVM, CDER, and NCTR; the Director, Office of Executive Operations, OSAC, OC; the Directors of the Offices of Management, CBER and CDER; the Director, Office of Management Systems, CFSAN; the Director, Office of Systems and Management, CDRH; the Director, Office of Management and Communications, CVM; the Associate Director, Office of Management Services, NCTR; the Director, Office of Resource Management, ORA; and the Director, OHRMS, OM, OC. The Center Director and Deputy Center Director, CDER, may further redelegate this authority. The other officials delegated authority by this section may not further redelegate it.

B. Under paragraph 1.C., the Chief, RES, RPMS, OPP may designate alternates, as required.

3. EFFECTIVE DATE.

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