[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: 21CFR21.61]
[Page 230-231]
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. 21.61 Exempt systems.
(a) Investigatory records compiled for law enforcement purposes,
including criminal law enforcement purposes, in the Food and Drug
Administration Privacy Act Record Systems listed in paragraph (b) of
this section are exempt from the following provisions of the Privacy Act
(5 U.S.C. 552a) and of this part:
(1) Such records are exempt from 5 U.S.C. 552a(c)(3) and Sec.
21.71(e)(4), requiring that an individual be provided with the
accounting of disclosures of records
[[Page 231]]
about himself from a Privacy Act Record System.
(2) Except where access is required under 5 U.S.C. 552a(k)(2) and
Sec. 21.65(a)(2), (such records are exempt from 5 U.S.C. 552a(d)(1)
through (4) and (f)) and Sec. Sec. 21.40 through 21.54, requiring
procedures for an individual to be given notification of and access to
records about himself in a Privacy Act Record System and to be allowed
to challenge the accuracy, relevance, timeliness, and completeness of
such records.
(3) Such records are exempt from 5 U.S.C. 552a(e)(4)(G) and (H) and
Sec. 21.20(b)(1) requiring inclusion in the notice for the system of
information about agency procedures for notification, access, and
contest.
(4) Such records are exempt from 5 U.S.C. 552a(e)(3) requiring that
individuals asked to supply information be provided a form outlining the
authority for the request, the purposes for which the information will
be used, the routine uses in the notice for the Privacy Act Record
System, and the consequences to the individual of not providing the
information, but only with respect to records compiled by the Food and
Drug Administration in a criminal law enforcement investigation where
the conduct of the investigation would be prejudiced by such procedures.
(b) Records in the following Food and Drug Administration Privacy
Act Record Systems that concern individuals who are subject to Food and
Drug Administration enforcement action and consist of investigatory
records compiled for law enforcement purposes, including criminal law
enforcement purposes, are exempt under 5 U.S.C. 552a(j)(2) and (k)(2)
from the provisions enumerated in paragraph (a) of this section:
(1) Bio-research Monitoring Information System--HHS/FDA/09-10-0010.
(2) Regulated Industry Employee Enforcement Records--HHS/FDA/ACMO/
09-10-002.
(3) Employee Conduct Investigative Records--HHS/FDA/ACMO/09-10-0013.
(c) The system described in paragraph (b)(3) of this section
includes investigatory records compiled solely for the purpose of
determining suitability, eligibility, or qualification for Federal
civilian employment, military service, Federal contracts, and access to
classified information. These records are exempt from disclosure under 5
U.S.C. 552a(k)(5) to the extent that the disclosure would reveal the
identity of a source who furnished information to the Government under a
promise of confidentiality, which must be an express promise if the
information was furnished after September 27, 1975. Any individual who
is refused access to a record that would reveal a confidential source
shall be advised in a general way that the record includes information
that would reveal a confidential source.
[42 FR 15626, Mar. 22, 1977, as amended at 46 FR 8459, Jan. 27, 1981; 50
FR 52278, Dec. 23, 1985]
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