[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR20.46]

[Page 203-204]
 
                        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. 20.46  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. 20.45, and rejects the person's request that part or all of the 
records

[[Page 204]]

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.