[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR20.28]

[Page 199]
 
                        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. 20.28  Food and Drug Administration determinations of confidentiality.

    A determination that data or information submitted to the Food and 
Drug Administration will be held in confidence and will not be available 
for public disclosure shall be made only in the form of a regulation 
published or cross-referenced in this part or by a written determination 
pursuant to the procedure established in Sec. 20.44.