[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: 21CFR21.1]
[Page 219]
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 A General Provisions
Sec. 21.1 Scope.
(a) This part establishes procedures to implement the Privacy Act of
1974 (5 U.S.C. 552a). It applies to records about individuals that are
maintained, collected, used, or disclosed by the Food and Drug
Administration and contained in Privacy Act Record Systems.
(b) This part does not:
(1) Apply to Food and Drug Administration record systems that are
not Privacy Act Record Systems or make available to an individual
records that may include references to him but that are not retrieved by
his name or other personal identifier, whether or not contained in a
Privacy Act Record System. part 20 of this chapter (the public
information regulations) and other regulations referred to therein
determine when records are made available in such cases.
(2) Make any records available to persons other than (i) individuals
who are the subjects of the records, (ii) persons accompanying such
individuals under Sec. 21.43, (iii) persons provided records pursuant
to individual consent under Sec. 21.72, or (iv) persons acting on
behalf of such individuals as legal guardians under Sec. 21.75. Part 20
of this chapter (the public information regulations) and other
regulations referred to therein determine when Food and Drug
Administration records are disclosable to members of the public
generally. Subpart G of this part limits the provisions of part 20 of
this chapter with respect to disclosures of records about individuals
from Privacy Act Record Systems to persons other than individuals who
are the subjects of the records.
(3) Make available information compiled by the Food and Drug
Administration in reasonable anticipation of court litigation or formal
administrative proceedings. The availability of such information to any
member of the public, including any subject individual or party to such
litigation or proceeding shall be governed by applicable constitutional
principles, rules of discovery, and part 20 of this chapter (the public
information regulations).
(4) Apply to personnel records maintained by the Division of Human
Resources Management, Food and Drug Administration, except as provided
in Sec. 21.32. Such records are subject to regulations of the Office of
Personnel Management in 5 CFR parts 293, 294, and 297.
[42 FR 15626, Mar. 22, 1977, as amended at 46 FR 8457, Jan. 27, 1981; 50
FR 52278, Dec. 23, 1985]
Back to Top
© 2007 Betterchem Corp.
|
