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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: 01/20/2011

[PDF Version]

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. Principal Deputy Commissioner; Deputy Commissioner for Policy, Planning and Budget; Deputy Commissioner for Administration; Deputy Commissioner for Foods; Deputy Commissioner for International Programs; Chief Scientist and Deputy Commissioner for Science and Public Health, and Chief of Staff

2. Associate Commissioners and Assistant Commissioners, Chief Counsel, Deputy Chief Counsels and Counselor to the Commissioner

3. Executive Secretariat, Office of the Chief of Staff, Office of the Commissioner (OC)

4. Director, Office of Executive Operations (OEO), OA, OC

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

6. Director and Deputy Director, Office of Regional Operations (ORO), ORA

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

8. Director, Division of Management Operations, ORM, ORA

9. Regional Food and Drug Directors, ORA

10. District Directors, ORA

11. Director, Northeast Regional Laboratory, Northeast Region, ORA

12. Director, Southeast Regional Laboratory, Southeast Region, ORA

13. Director, National Forensic Chemistry Center, ORA

14. Director, Arkansas Regional Laboratory, ORA

15. Director, Winchester Engineering Analytical Center, ORA

16. Chief Information Officer, Office of Information Management (OIM),OA, OC

17. Director, Office of Management Programs (OMP), Office of Business Operations and Human Capital Programs (OBOHCP), OM, OA, OC

18. Director, Freedom of Information, (DFOI), OPILS, OSS, OM, OA, OC

19. Director, DDM, OPILS, OSS, OM, OA, OC

20. Director and Deputy Director, Center for Biologics Evaluation and Research (CBER)

21. Director and Deputy Director, Office of Management ( OM), CBER

22. Director and Deputy Director, Office of Compliance and Biologics Quality, CBER

23. Director and Deputy Director, Office of Communication, Outreach and Development, CBER

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

25. Director and Deputy Directors, Center for Food Safety and Applied Nutrition (CFSAN)

26. Director, Office of Regulations, Policy and Social Sciences, CFSAN

27. Director, Office of Management Systems, (OMS), CFSAN

28. Director, Office of Cosmetics and Colors, CFSAN

29. Director, Office of Food Safety, CFSAN

30. Director, Office of Nutrition, Labeling, and Dietary Supplements, CFSAN

31. Director, Office of Regulatory Science, CFSAN

32. Director, Office of Compliance, CFSAN

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

34. Director, Office of Applied Research and Safety Assessment, CFSAN

35. Director, Office of Food Defense, Communication and Emergency Response, CFSAN

36. Director, Deputy Directors, and Senior Associate Director, Center for Devices and Radiological Health (CDRH)

37. Associate Director for Management, Office of the Center Director, CDRH

38. Director and Deputy Directors, Office of Compliance (OC), CDRH

39. For medical devices assigned to their respective divisions, Division Directors, OC, CDRH

40. Director and Deputy Directors, Office of Surveillance and Biometrics (OSB), CDRH, and Director and Deputy Director, Division of Patient Safety, Office of Surveillance and Biometrics, CDRH

41. Director, Office of Management Operations (OMO), CDRH

42. Freedom of Information Officers, OMO, CDRH

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

44. Associate Director and Deputy Associate Director for Management, CTP

45. Director, Office of Policy, CTP

46. Associate Director for Regulations, Office of Regulations (OR), CTP; and Deputy Director for Compliance, OR, CTP

47. Director, Office of Science (OS), CTP; and Deputy Director, OS, CTP

48. Director, Deputy Director, Senior Advisor for Science Policy, Center for Veterinary Medicine (CVM)

49. Associate Director for Policy and Communications, Office of Center Director, CVM

50. Director and Deputy Director, Office of Surveillance and Compliance (OSC), CVM

51. Director, Division of Compliance, OSC, CVM

52. Director, Deputy Director and Associate Directors for Research, Management, Executive Programs and Services, and Regulatory Activities, respectively, NCTR

53. Associate Director for Management, Office of Management, NCTR

54. Director and Deputy Directors, Center for Drug Evaluation and Research (CDER)

55. Directors and Deputy Directors, Office of New Drugs (OND), Office of Pharmaceutical Science (OPS), Office of Translational Sciences (OTS), Office of Counter-Terrorism and Emergency Coordination (OCTEC), Office of Executive Programs (OEP), and Office of Surveillance and Epidemiology (OSE); Associate Director for Policy, Office of Regulatory Policy (ORP); and Associate Director for Medical Policy, Office of Medical Policy, CDER

56. Director and Deputy Director, Office of Management ( OM), CDER

57. Director and Deputy Director, Office of Compliance (OC), CDER

58. Directors and Deputy Directors of the Offices of Drug Evaluation I, II, III, and IV, Office of Antimicrobial Products, and Office of Oncology Drug Products, OND, CDER

59. Directors and Deputy Directors of the Office of Testing and Research, Office of Generic Drugs, Office of New Drug Quality Assessment, and Office of Biotechnology Products, OPS; Office of Biostatistics and Office of Clinical Pharmacology, OTS; and Office of Business Informatics, Office of Planning and Informatics, CDER

60. Director, Division of Information Disclosure Policy, ORP, CDER

61. Directors, Division of New Drugs and Labeling Compliance, Division of Manufacturing and Product Quality, and Division of Compliance Risk Management and Surveillance, OC, CDER

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. Principal Deputy Commissioner, Deputy Commissioner for Policy, Planning and Budget, Deputy Commissioner for Administration, Deputy Commissioner for International Programs, Chief Scientist and Deputy Commissioner for Science and Public Health, and Chief of Staff

2. Associate Commissioners, Assistant Commissioners, Chief Counsel and Deputy Chief Counsel

3. Executive Secretariat, Office of the Chief of Staff, OC

4. Director and Deputy Director, CBER; Director and Deputy Directors, CFSAN; Director, Deputy Directors, and Senior Associate Director, CDRH; Director, Executive Director, and Senior Advisor for Science Policy, CVM; Director and Deputy Directors, CDER; Director, NCTR; Associate Directors, Offices of Regulatory Compliance and Risk Management, Management, Executive Programs and Services, and Research, NCTR; and Director, CTP

5. Director, OEO, OA, OC; Director, OM, CBER; Director, Office of Management (OM), CDER; Director, OMS, CFSAN; Director, OMO, CDRH; Associate Director for Management, Office of Management, CVM; and Director, ORM, ORA

6. Director, OMP, OBOHCP, OM, OA, OC

C. Chief, Regulations Editorial Section (RES), Regulations Policy and Management Staff (RPMS), Office of Policy, Planning and Budget (OPPB), 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 delegation:

1. Principal Deputy Commissioner; Deputy Commissioner for International Programs, OC; Deputy Commissioner for Administration, OC; Deputy Commissioner for Policy, Planning and Budget, OC ; Deputy Commissioner for Foods, OC; Chief Scientist and Deputy Commissioner for Science and Public Health, OC; Associate and Assistant Commissioners; Chief Counsel and Deputy Chief Counsel

2. Directors and Deputy Directors for CBER, CFSAN, CDRH, CDER, CTP and NCTR; Director, Deputy Director, and Senior Advisor for Science Policy, CVM

3. Center Associate Directors for Management; Director, OM, CDER; Director, ORM, ORA; Director, OEO, OA, OC; and Director, OMP,OBOHCP, OM, OA, OC

B. The other Officials delegated authority by this section may not further redelegate it.

C. Under paragraph 1.C., Chief, RES, RPMS, OPPB may designate alternates, as required.

3. EFFECTIVE DATE.

The Commissioner of Food and Drugs approved this delegation, via memorandum, on January 20, 2011.

STATUS (I, R, C)DATE APPROVEDLOCATION OF CHANGE HISTORYCONTACTAPPROVING OFFICIAL
Initial01/20/2011N/aFDA/OC/OA/OM/OMPMargaret A. Hamburg M.D., Commissioner of Food and Drugs