[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: 21CFR20.20]
[Page 189]
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 B General Policy
Sec. 20.20 Policy on disclosure of Food and Drug Administration records.
(a) The Food and Drug Administration will make the fullest possible
disclosure of records to the public, consistent with the rights of
individuals to privacy, the property rights of persons in trade secrets
and confidential commercial or financial information, and the need for
the agency to promote frank internal policy deliberations and to pursue
its regulatory activities without disruption.
(b) Except where specifically exempt pursuant to the provisions of
this part, all Food and Drug Administration records shall be made
available for public disclosure.
(c) Except as provided in paragraph (d) of this section, all
nonexempt records shall be made available for public disclosure upon
request regardless whether any justification or need for such records
have been shown.
(d) Under Sec. 21.71 of this chapter, a statement of the purposes
to which the record requested is to be put, and a certification that the
record will be so used, may be requested when:
(1) The requested record is contained in a Privacy Act Record System
as defined in Sec. 21.3(c) of this chapter;
(2) The requester is a person other than the individual who is the
subject of the record that is so retrieved or a person acting on his
behalf; and
(3) The disclosure is one that is discretionary, i.e., not required
under this part.
(e) ``Record'' and any other term used in this section in reference
to information includes any information that would be an agency record
subject to the requirements of this part when maintained by the agency
in any format, including an electronic format.
[42 FR 15616, Mar. 22, 1977, as amended at 68 FR 25285, May 12, 2003]
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