[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: 21CFR7.87]
[Page 75-76]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
PART 7 ENFORCEMENT POLICY--Table of Contents
Subpart E Criminal Violations
Sec. 7.87 Records related to opportunities for presentation of views
conducted before report of criminal violation.
(a) Records related to a section 305 opportunity for presentation of
views constitute investigatory records for law enforcement purposes and
may include inter- and intra-agency memorandums.
(1) Notwithstanding the rule established in Sec. 20.21 of this
chapter, no record related to a section 305 presentation is available
for public disclosure until consideration of criminal prosecution has
been closed in accordance with paragraph (b) of this section, except as
provided in Sec. 20.82 of this chapter. Only very rarely and only under
circumstances that demonstrate a compelling public interest will the
Commissioner exercise, in accordance with Sec. 20.82 of this chapter,
the authorized discretion to disclose records related to a section 305
presentation before the consideration of criminal prosecution is closed.
(2) After consideration of criminal prosecution is closed, the
records are available for public disclosure in response to a request
under the Freedom of Information Act, except to the extent that the
exemptions from disclosure in subpart D of part 20 of this chapter are
applicable. No statements obtained through promises of confidentiality
shall be available for public disclosure.
(b) Consideration of criminal prosecution based on a particular
section 305 notice of opportunity for presentation of views shall be
deemed to be closed within the meaning of this section and Sec. 7.85
when a final decision has been made not to recommend criminal
prosecution to a United States attorney based on charges set forth in
the notice and considered at the presentation, or when such a
recommendation has been finally refused by the United States attorney,
or when criminal prosecution has been instituted and the matter and all
related appeals have been concluded, or when the statute of limitations
has run.
(c) Before disclosure of any record specifically reflecting
consideration of a possible recommendation for criminal prosecution of
any individual, all names and other information that would identify an
individual whose prosecution was considered but not recommended, or who
was not prosecuted, shall be deleted, unless the Commissioner concludes
that there is a compelling public interest in the disclosure of the
names.
(d) Names and other information that would identify a Food and Drug
Administration employee shall be deleted from records related to a
section 305
[[Page 76]]
presentation of views before public disclosure only under Sec. 20.32 of
this chapter.
[44 FR 12168, Mar. 6, 1979]
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