[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: 21CFR20.48]
[Page 198]
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 C Procedures and Fees
Sec. 20.48 Judicial review of proposed disclosure.
Where the Food and Drug Administration consults with a person who
will be affected by a proposed disclosure of data or information
contained in Food and Drug Administration records pursuant to Sec.
20.47, and rejects the person's request that part or all of the records
not be made available for public disclosure, the decision constitutes
final agency action that is subject to judicial review pursuant to 5
U.S.C. chapter 7. The person affected will be permitted 5 days after
receipt of notification of such decision within which to institute suit
in a United States District Court to enjoin release of the records
involved. If suit is brought, the Food and Drug Administration will not
disclose the records involved until the matter and all related appeals
have been concluded.
[42 FR 15616, Mar. 22, 1977. Redesignated and amended at 68 FR 25286,
25287, May 12, 2003]
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