[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: 21CFR5.23]

[Page 36-37]
 
                        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. 5.23  Disclosure of official records.

    (a) The following officials are authorized to make determinations to 
disclose official records and information under part 20 of this chapter, 
except that only the officials listed in paragraph (a)(1) of this 
section may disclose official records and information under Secs. 20.82 
and 20.85 of this chapter, and only officials listed in paragraph 
(a)(10) of this section may disclose information under Sec. 20.89(c) of 
this chapter.
    (1) The Deputy Commissioner, the Deputy Commissioner for 
International and Constituent Relations, the Deputy Commissioner for 
Management and Systems, Senior Associate Commissioners, Associate and 
Deputy Associate Commissioners.
    (2)(i) The Executive Assistant to the Commissioner, Office of the 
Commissioner.
    (ii) The Director, Office of the Executive Secretariat, Office of 
the Senior Associate Commissioner, Office of the Commissioner.
    (3) Executive Officer, Office of the Commissioner.
    (4)(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 Services, Office of the Commissioner.
    (5) Program officials at all organizational levels down to and 
including branch level for all Headquarters organizations.
    (6) Regional Food and Drug Directors and District Directors.
    (7) Director, Winchester Engineering and Analytical Center.
    (8) Chiefs of branches Field/District Offices and Centers.
    (9) Freedom of Information Officers and other employees engaged in 
Freedom of Information activities.
    (10)(i) The Associate Commissioner for Regulatory Affairs, Deputy 
Associate Commissioner for Regulatory Affairs, and Director, Office of 
Enforcement, FDA.
    (ii) The Director, Deputy Director, and Associate Director for 
Policy Coordination and Public Affairs, Center for Biologics Evaluation 
and Research (CBER), and Director, Division of Congressional and Public 
Affairs, CBER.
    (iii) The Director, Deputy Directors, and Associate Director for 
Science and Medical Affairs, Center for Drug Evaluation and Research 
(CDER).
    (iv) The Director and Deputy Director for Regulations and Policy, 
Center for Devices and Radiological Health (CDRH).
    (v) The Director, Center for Food Safety and Applied Nutrition 
(CFSAN), and Deputy Director for Systems and Support, CFSAN.
    (vi) The Director and Deputy Director, Center for Veterinary 
Medicine (CVM).
    (vii) The Director, Deputy Director, and Associate Director for 
Scientific Coordination, National Center for Toxicological Research 
(NCTR).
    (b) The Chief, Product Information Management Branch, Division of 
Database Management, Office of Management, Center for Drug Evaluation 
and Research (CDER), is authorized to sign affidavits regarding the 
presence or absence of records of Registration of Drug Establishments.
    (c) The following officials are authorized to sign affidavits 
regarding the presence or absence of medical device establishment 
registration records:

[[Page 37]]

    (1) The Director and Deputy Directors, Center for Devices and 
Radiological Health (CDRH).
    (2) The Director and Deputy Director, Office of Compliance, CDRH.
    (3) The Director and Deputy, Division of Program Operations, Office 
of Compliance, CDRH.
    (4) The Chief, Information Processing and Automation Branch, 
Division of Program Operations, Office of Compliance, CDRH.
    (5) The Director and Deputy Director, Office of Surveillance and 
Biometrics (OSB), CDRH, the Director and Deputy Director, Division of 
Surveillance Systems (DSS), OSB, CDRH, and the Chief Reporting Systems 
Monitoring Branch, DSS, OSB, CDRH.
    (d) The Director, Office of Resource Management, Office of 
Regulatory Affairs is authorized to sign affidavits regarding the 
presence or absence of records in the files of that office.
    (e) The Director and Deputy Director, Division of Product 
Certification, Office of Biological Product Review, Center for Biologics 
Evaluation and Research, are authorized to sign affidavits regarding the 
presence or absence of records of registration of blood product 
establishments.

[43 FR 29286, July 7, 1978, as amended at 48 FR 56946, Dec. 27, 1983; 49 
FR 14932, Apr. 16, 1984; 50 FR 4859, Feb. 4, 1985; 51 FR 11428, Apr. 3, 
1986; 54 FR 8315, Feb. 28, 1989; 55 FR 47053, Nov. 9, 1990; 57 FR 40318, 
Sept. 3, 1992; 59 FR 37419, July 22, 1994; 62 FR 2554, Jan. 17, 1997; 62 
FR 67270, Dec. 24, 1997; 64 FR 4965, Feb. 2, 1999; 65 FR 34961, June 1, 
2000]