[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: 21CFR7.87]

[Page 81]
 
                        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 presentation of views before public disclosure only under 
Sec. 20.32 of this chapter.

[44 FR 12168, Mar. 6, 1979]