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(a) Except as provided in paragraph (b) of this section, the Commissioner may, in his or her discretion, disclose part or all of any Food and Drug Administration (FDA) record that is otherwise exempt from disclosure pursuant to subpart D of this part. As set forth in § 20.20(b), FDA will withhold requested information only if:
(1) The Agency reasonably foresees that disclosure would harm an interest protected by an exemption described in this part; or
(2) Disclosure is prohibited by law. FDA shall exercise its discretion to disclose such records whenever it determines that such disclosure is in the public interest, will promote the objectives of the Freedom of Information Act and the Agency, and is, for example, 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 § 20.61.
(2) Exempt from public disclosure pursuant to § 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 § 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; 87 FR 55913, Sept. 13, 2022]
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