[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR20.82]
[Page 205]
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 under statute.
(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.
[42 FR 15616, Mar. 22, 1977, as amended at 70 FR 41958, July 21, 2005]
[[Page 206]]
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