[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR20.82]

[Page 212]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                                SERVICES
 
PART 20--PUBLIC INFORMATION--Table of Contents
 
                  Subpart E--Limitations on Exemptions
 
Sec. 20.82  Discretionary disclosure by the Commissioner.

    (a) Except as provided in paragraph (b) of this section, the 
Commissioner may, in his discretion, disclose part or all of any Food 
and Drug Administration record that is otherwise exempt from disclosure 
pursuant to subpart D of this part. The Commissioner shall exercise his 
discretion to disclose such records whenever he determines that such 
disclosure is in the public interest, will promote the objectives of the 
act and the agency, and is consistent with the rights of individuals to 
privacy, the property rights of persons in trade secrets, and the need 
for the agency to promote frank internal policy deliberations and to 
pursue its regulatory activities without disruption.
    (b) The Commissioner shall not make available for public disclosure 
any record that is:
    (1) Exempt from public disclosure pursuant to Sec. 20.61.
    (2) Exempt from public disclosure pursuant to Sec. 20.63.
    (3) Prohibited from public disclosure pursuant to 21 U.S.C. 331(j), 
42 U.S.C. 263g(d), 42 U.S.C. 263i, or 18 U.S.C. 1905.
    (4) Contained in a Privacy Act Record System where disclosure would 
constitute a clearly unwarranted invasion of personal privacy or is 
otherwise in violation of 5 U.S.C. 552a(b), as applied in part 21, 
subpart G, of this chapter (restrictions on disclosure in the privacy 
regulations).
    (c) Discretionary disclosure of a record pursuant to this section 
shall invoke the requirement that the record shall be disclosed to any 
person who requests it pursuant to Sec. 20.21, but shall not set a 
precedent for discretionary disclosure of any similar or related record 
and shall not obligate the Commissioner to exercise his discretion to 
disclose any other record that is exempt from disclosure.