[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: 21CFR21.65]
[Page 231-232]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
PART 21 PROTECTION OF PRIVACY--Table of Contents
Subpart F Exemptions
Sec. 21.65 Access to records in exempt systems.
(a) Where a Privacy Act Record System is exempt and the requested
records are unavailable under Sec. 21.61, an individual may
nevertheless make a request under Sec. 21.40 for notification
concerning whether any records about him exist and request access to
such records where they are retrieved by his name or other personal
identifier.
(b) An individual making a request under paragraph (a) of this
section;
(1) May be given access to the records where available under part 20
of this chapter (the public information regulations) or the Commissioner
may, in his discretion, entertain a request under any or all of the
provisions of Sec. Sec. 21.40 through 21.54; and
(2) Shall be given access upon request if the records requested are
subject to 5 U.S.C. 552a(k)(2) and not to 5 U.S.C. 552a(j)(2) (i.e.,
because they consist of investigatory material compiled for law
enforcement purposes other than criminal law enforcement purposes) and
maintenance of the records resulted in denial to the individual of any
right, benefit, or privilege to which he would otherwise be entitled by
Federal law, or for which he would otherwise be eligible. An individual
given access to a record under this paragraph (b)(2) is not entitled to
seek amendment under subpart E of this part. The FDA may refuse to
disclose a record that would reveal the identity of a
[[Page 232]]
source who furnished information to the Government under a promise of
confidentiality, which must be an express promise if the information was
furnished on or after September 27, 1975. Any individual refused access
to a record that would reveal a confidential source shall be advised in
a general way that the record contains information that would reveal a
confidential source.
(c) The Commissioner shall not make available any record that is
prohibited from public disclosure under Sec. 20.82(b) of this chapter.
(d) Discretionary disclosure of a record pursuant to paragraph
(b)(1) of this section shall not set a precedent for discretionary
disclosure of a similar or related record and shall not obligate the
Commissioner to exercise his discretion to disclose any other record in
a system that is exempt under Sec. 21.61.
Back to Top
© 2007 Betterchem Corp.
|
