[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
[[Page 203]]
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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