[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: 21CFR20.20]

[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 B--General Policy
 
Sec. 20.20  Policy on disclosure of Food and Drug Administration records.


    (a) The Food and Drug Administration will make the fullest possible 
disclosure of records to the public, consistent with the rights of 
individuals to privacy, the property rights of persons in trade secrets 
and confidential commercial or financial information, and the need for 
the agency to promote frank internal policy deliberations and to pursue 
its regulatory activities without disruption.
    (b) Except where specifically exempt pursuant to the provisions of 
this part, all Food and Drug Administration records shall be made 
available for public disclosure.
    (c) Except as provided in paragraph (d) of this section, all 
nonexempt records shall be made available for public disclosure upon 
request regardless whether any justification or need for such records 
have been shown.
    (d) Under Sec. 21.71 of this chapter, a statement of the purposes to 
which the record requested is to be put, and a certification that the 
record will be so used, may be requested when:
    (1) The requested record is contained in a Privacy Act Record System 
as defined in Sec. 21.3(c) of this chapter;
    (2) The requester is a person other than the individual who is the 
subject of the record that is so retrieved or a person acting on his 
behalf; and
    (3) The disclosure is one that is discretionary, i.e., not required 
under this part.