[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: 21CFR20.80]
[Page 204-205]
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 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.
[[Page 205]]
(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.
Back to Top
© 2007 Betterchem Corp.
|
