[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: 21CFR20.21]
[Page 189.190]
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. 20.21 Uniform access to records.
Any record of the Food and Drug Administration that is disclosed in
an authorized manner to any member of the public is available for
disclosure to all members of the public, except that:
(a) Data and information subject to the exemptions established in
Sec. 20.61 for
[[Page 190]]
trade secrets and confidential commercial or financial information, and
in Sec. 20.63 for personal privacy, shall be disclosed only to the
persons for the protection of whom these exemptions exist.
(b) The limited disclosure of records permitted in Sec. 7.87(c) of
this chapter for section 305 hearing records, in Sec. 20.80(b)
regarding certain limitations on exemptions, in Sec. 20.103(b) for
certain correspondence, and in Sec. 20.104(b) for certain summaries of
oral discussions, shall be subject to the special rules stated therein.
(c) Disclosure of a record about an individual, as defined in Sec.
21.3(a) of this chapter, that is retrieved by the individual's name or
other personal identifier and is contained in a Privacy Act Record
System, as defined in Sec. 21.3(c) of this chapter, shall be subject to
the special requirements of part 21 of this chapter. Disclosure of such
a record to an individual who is the subject of the record does not
invoke the rule established in this section that such records shall be
made available for disclosure to all members of the public.
[42 FR 15616, Mar. 22, 1977, as amended at 54 FR 9037, Mar. 3, 1989]
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