TITLE 21 - FOOD AND DRUGS

CHAPTER I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES

SUBCHAPTER A - GENERAL

PART 20 - PUBLIC INFORMATION

subpart b - GENERAL POLICY

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 20.61 for trade secrets and confidential commercial or financial information, and in 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 7.87(c) of this chapter for section 305 hearing records, in 20.80(b) regarding certain limitations on exemptions, in 20.103(b) for certain correspondence, and in 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 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 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]