[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR20.80]

[Page 211-212]
 
                        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 E--Limitations on Exemptions
 
Sec. 20.80  Applicability of limitations on exemptions.


    (a) The limitations on exemptions established in this subpart shall 
apply to all Food and Drug Administration records, except as 
specifically provided herein. Accordingly, a record that is ordinarily 
exempt from public disclosure in accordance with the provisions in 
subpart D of this part is available for such disclosure to the extent 
that it falls within a limitation on the exemption contained in this 
subpart. For example, an investigatory record that is ordinarily exempt 
from disclosure under Sec. 20.64 is disclosable to Congress in 
accordance with the provisions of Sec. 20.87.
    (b) Disclosure of a record to any member of the public pursuant to 
the provisions in Sec. 20.81, data and information previously disclosed 
to the public, in Sec. 20.82, discretionary disclosure by the 
Commissioner, and in Sec. 20.83, disclosure pursuant to a court order, 
shall involve the rule established in Sec. 20.21 that the record shall 
be made available for disclosure to all members of the public who 
request it. Disclosure of a record only to the limited categories of 
persons and under the conditions specified in Sec. 20.84, special 
government employees, in Sec. 20.85, other Federal government 
departments and agencies, in

[[Page 212]]

Sec. 20.86, in camera disclosure in administrative or court proceedings, 
in Sec. 20.87(b), Congress, in Sec. 20.88, State and local government 
officials, in Sec. 20.89, foreign government officials, and in 
Sec. 20.90, contractors, which does not result in disclosure of the 
record to any member of the public in an authorized manner, shall not 
invoke the rule established in Sec. 20.21.
    (c) Disclosure to government employees and special government 
employees of records exempt from public disclosure shall subject those 
persons to the same restrictions with respect to the disclosure of such 
records as any Food and Drug Administration employee.
    (d) In the case of a record in a Privacy Act Record System, as 
defined in Sec. 21.3(c) of this chapter:
    (1) The availability to an individual, as defined in Sec. 21.3(a), 
of a record about himself that is retrieved by the individual's name or 
other personal identifier and is contained in a Privacy Act Record 
System shall be subject to the special requirements of part 21 of this 
chapter (the privacy regulations) and shall not be subject to the 
exemptions in subpart D of this part except that where the system is 
exempt and the requested record is not available under Sec. 21.61 of 
this chapter, the provisions of this part shall apply.
    (2) The availability of a record about an individual to persons 
other than the individual who is the subject of the record shall be 
subject to the special requirements of part 21, subpart G, of this 
chapter (restrictions on disclosure in the privacy regulations), and 
shall not be subject to the limitations on exemptions in this subpart 
except as provided in part 21, subpart G, of this chapter.