[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: 21CFR20.64]

[Page 202-203]
 
                        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 D_Exemptions
 
Sec.  20.64  Records or information compiled for law enforcement purposes.

    (a) Records or information compiled for law enforcement purposes may 
be withheld from public disclosure pursuant to the provisions of this 
section to the extent that disclosure of such records or information:
    (1) Could reasonably be expected to interfere with enforcement 
proceedings;
    (2) Would deprive a person to a right to a fair trial or an 
impartial adjudication;
    (3) Could reasonably be expected to constitute an unwarranted 
invasion of personal privacy;
    (4) Could reasonably be expected to disclose the identity of a 
confidential

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source, including a State, local, or foreign agency or authority or any 
private institution which furnished information on a confidential basis; 
and information furnished by a confidential source in the case of a 
record compiled by the Food and Drug Administration or any other 
criminal law enforcement authority in the course of a criminal 
investigation or by an agency conducting a lawful national security 
intelligence investigation;
    (5) Would disclose techniques and procedures for law enforcement 
investigations or prosecutions or would disclose guidelines for law 
enforcement investigations or prosecutions, if such disclosure could 
reasonably be expected to risk circumvention of the law; or
    (6) Could reasonably be expected to endanger the life or physical 
safety of any individual.
    (b) Records include all records relating to regulatory enforcement 
action, including both administrative and court action, which have not 
been disclosed to any member of the public, including any person who is 
the subject of the investigation.
    (c) Any record which is disclosed to any person, including any 
person who is the subject of a Food and Drug Administration 
investigation, and any data or information received from any person who 
is the subject of a Food and Drug Administration investigation relating 
to such investigation, is available for public disclosure at that time 
in accordance with the rule established in Sec.  20.21, except that:
    (1) Disclosure of such records shall be subject to the other 
exemptions established in this subpart and to the limitations on 
exemptions established in subpart E of this part.
    (2) The record of a section 305 hearing shall be available for 
public disclosure only in accordance with the provisions of Sec.  7.87 
of this chapter.
    (d) Records for law enforcement purposes shall be subject to the 
following rules:
    (1) No such record is available for public disclosure prior to the 
consideration of regulatory enforcement action based upon that record's 
being closed, except as provided in Sec.  20.82. The Commissioner will 
exercise his discretion to disclose records relating to possible 
criminal prosecution pursuant to Sec.  20.82 prior to consideration of 
criminal prosecution being closed only very rarely and only under 
circumstances that demonstrate a compelling public interest.
    (2) After the consideration of regulatory enforcement action is 
closed, such records shall be made available for public disclosure 
except to the extent that other exemptions from disclosure in this 
subpart are applicable. No statements of witnesses obtained through 
promises of confidentiality are available for public disclosure.
    (3) The consideration of regulatory enforcement action based upon a 
particular record shall be deemed to be closed within the meaning of 
this section:
    (i) If it relates to administrative action, when a final decision 
has been made not to take such action or such action has been taken and 
the matter has been concluded.
    (ii) If it relates to court action, when a final decision has been 
made not to recommend such action to a United States attorney based upon 
that record, or a recommendation has been finally refused by a United 
States attorney, or court action has been instituted and the matter and 
all related appeals have been concluded, or the statute of limitations 
runs.
    (iii) If it relates to both administrative and court action, when 
the events described in both paragraph (d)(3) (i) and (ii) of this 
section have occurred.
    (4) Prior to disclosure of any record specifically reflecting 
consideration of possible criminal prosecution of any individual, all 
names and other information that would identify an individual who was 
considered for criminal prosecution but who was not prosecuted shall be 
deleted unless the Commissioner concludes that there is a compelling 
public interest in the disclosure of such names.
    (e) Names and other information that would identify a Food and Drug 
Administration employee shall be deleted from records prior to public 
disclosure only pursuant to Sec.  20.32.

[42 FR 15616, Mar. 22, 1977, as amended at 59 FR 536, Jan. 5, 1994]

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