[Code of Federal Regulations] [Title 21, Volume 1] [Revised as of April 1, 2001] From the U.S. Government Printing Office via GPO Access [CITE: 21CFR5.22] [Page 34-36] TITLE 21--FOOD AND DRUGS CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES PART 5--DELEGATIONS OF AUTHORITY AND ORGANIZATION--Table of Contents Subpart B--Redelegations of Authority from the Commissioner of Food and Drugs Sec. 5.22 Certification of true copies and use of Department seal. (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, the Deputy Commissioner for International and Constituent Relations, and the Deputy Commissioner for Management and Systems. (2) The Senior Associate Commissioners, the Associate and Deputy Associate Commissioners, and the Chief Counsel and Deputies. (3) The Director, Office of the Executive Secretariat, Office of the Senior Associate Commissioner, Office of the Commissioner. (4) The Executive Assistant to the Commissioner, Office of the Commissioner. (5)(i) The Director and Deputy Director, Office of Enforcement, Office of Regulatory Affairs (ORA). (ii) The Director and Deputy Director, Office of Regional Operations, ORA. (iii) The Director and Deputy Director, Office of Resource Management, ORA. (iv) The Director, Division of Management Operations, and Chief, Administrative Management Branch, Office of Resource Management, ORA. (v) The Director, FDA History Staff, ORA. (6)(i) The Director, Office of Human Resources and Management Services, Office of Management and Systems, Office of the Commissioner. (ii) The Director, Division of Management Programs, Office of Human Resources and Management Services, Office of Management and Systems, Office of the Commissioner. (iii) The Chief, Dockets Management Branch, Division of Management Programs, Office of Human Resources and Management Services, Office of Management and Systems, Office of the Commissioner. (7)(i) The Associate Commissioner for Public Affairs, Office of Public Affairs, Office of the Senior Associate Commissioner, Office of the Commissioner. (ii) The Director, Freedom of Information Staff, Office of Public Affairs, Office of the Senior Associate Commissioner, Office of the Commissioner. (8)(i) The Director and Deputy Directors, Center for Biologics Evaluation and Research (CBER). (ii) The Director, Office of Management, CBER. (iii) The Directors and Deputy Directors of the Office of Compliance, CBER. (iv) The Director of Congressional and Public Affairs Staff, Office of the Center Director, CBER. (v) The Chief, Surveillance and Policy Branch and Consumer Safety Officers, Office of Compliance, CBER. (9)(i) The Director and Deputy Directors, Center for Food Safety and Applied Nutrition (CFSAN). (ii) The Director, Office of Policy, Planning, and Strategic Initiatives, CFSAN. (iii) The Director, Office of Management Systems, CFSAN. (iv) The Director, Office of Cosmetics and Colors, CFSAN. (v) The Director, Office of Plant and Dairy Foods Beverages, CFSAN. (vi) The Director, Office of Seafood, CFSAN. (vii) The Director, Office of Special Nutritional, CFSAN. (viii) The Director, Office of Special Research Skills, CFSAN. (ix) The Director, Office of Constituent Operations, CFSAN. (x) The Director, Office of Field Programs, CFSAN. (xi) The Director, Office of Premarket Approval, CFSAN. (xii) The Director, Office of Scientific Analysis and Support, CFSAN. (xiii) The Director, Office of Food Labeling, CFSAN. [[Page 35]] (10)(i) The Director and Deputy Directors, Center for Devices and Radiological Health (CDRH). (ii) The Director and Deputy Director, Office of Management and Communications, Center for Veterinary Medicine (CVM). (iii) The Director and Deputy Director, Office of Compliance, CDRH. (iv) For medical devices assigned to their respective divisions, the Division Directors, Office of Compliance, CDRH. (v) 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. (vi) Freedom of Information Officers, CDRH. (11)(i) The Director and Deputy Directors, Center for Veterinary Medicine (CVM). (ii) The Director and Deputy Director, Office of Management and Communications, CVM. (iii) The Director and Deputy Director, Office of Surveillance and Compliance, CVM. (iv) The Director, Division of Compliance, Office of Surveillance and Compliance, CVM. (v) The Chief, Case Guidance Branch, Division of Compliance, Office of Surveillance and Compliance, CVM. (12)(i) The Director and Deputy Director, National Center for Toxicological Research (NCTR). (ii) The Director, Office of Management, Facilities, and Research Support, NCTR. (13)(i) The Director, Deputy Center Director for Review Management, and Deputy Center Director for Pharmaceutical Science, Center for Drug Evaluation and Research (CDER). (ii) The Director and Deputy Director, Office of Management, CDER. (iii) The Director and Deputy Director, Office of Compliance, CDER. (iv) The Directors of the Offices of Drug Evaluation I, II, III, IV, and V, and the Director and Deputy Director of the Office of Epidemiology and Biostatistics, Office of Review Management, CDER. (v) The Directors and Deputy Directors of the Offices of Testing and Research, Generic Drugs, New Drug Chemistry, and Clinical Pharmacology and Biopharmaceutics, Office of Pharmaceutical Science, CDER. (vi) The Chief, Freedom of Information Staff, Office of Training and Communications, CDER. (vii) The Directors of the Divisions of Labeling and Nonprescription Drug Compliance, Prescription Drug Compliance and Surveillance, and Manufacturing and Product Quality, Office of Compliance, CDER. (14)(i) Regional Food and Drug Directors. (ii) District Directors. (iii) The Director, St. Louis Branch. (iv) The Director, New York Laboratory Division, Northeast Region. (v) The Director, Southeast Regional Laboratory, Southeast Region. (vi) The Director, National Forensic Chemistry 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, the Deputy Commissioner for International and Constituent Relations, and the Deputy Commissioner for Management and Systems. (2) The Senior Associate Commissioners, the Associate and Deputy Associate Commissioners, and the Chief Counsel and Deputies. (3) The Director, Office of Human Resources and Management Services, Office of Management and Systems, Office of the Commissioner. (c) The authorities under Sec. 5.22 (a) and (b), where appropriate, may be further redelegated by the Deputy Commissioners; Senior Associate Commissioners; Associate Commissioner for Regulatory Affairs and Deputy; Chief Counsel and Deputies; Center Directors and Deputies; and Executive Officers (i.e., Executive Assistant, Office of the Commissioner; Director, Office of Management, CBER; Director, Office of Management, CDER; Director, Office of Management and Systems, CFSAN; Director, Office of Systems and Management, CDRH; Director, Office of Management and Communications, CVM; Director, Office of Management, Facilities, and Research Support, NCTR; and the Director, Office of Resource Management, ORA). [[Page 36]] (d) The Chief, Regulations Editorial Section; Regulations Policy and Management Staff; Office of Policy, Planning, and Legislation; Office of the Commissioner, and his/her alternates are authorized to certify true copies of Federal Register documents. The Chief, Regulations Editorial Section; Regulations Policy and Management Staff; Office of Policy, Planning, and Legislation; and the Office of the Commissioner may designate alternates as required. [50 FR 4858, Feb. 4, 1985, as amended at 58 FR 17095, Apr. 1, 1993; 60 FR 26826, May 19, 1995; 61 FR 9639, Mar. 11, 1996; 62 FR 2554, Jan. 17, 1997; 62 FR 67270, Dec. 24, 1997; 64 FR 4965, Feb. 2, 1999; 64 FR 49383, Sept. 13, 1999; 65 FR 34961, June 1, 2000]