[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: 21CFR21.32]
[Page 223-224]
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 C Requirements for Specific Categories of Records
Sec. 21.32 Personnel records.
(a) Present and former Food and Drug Administration employees
desiring access to personnel records about themselves should consult
system notices applicable to the agency's personnel records that are
published by the Office of Personnel Management and the Department as
well as any notice issued by the Food and Drug Administration.
(b)(1) The procedures of the Office of Personnel Management at 5 CFR
parts 293, 294, and 297 rather than the procedures in Sec. 21.33 and
subparts D through F of this part, govern systems of personnel records
about Food and Drug Administration employees that are subject to notice
published by the Office of Personnel Management, i.e., systems that:
(i) The Office of Personnel Management maintains.
(ii) Are maintained by the Division of Human Resources Management,
Food and Drug Administration.
(iii) Are maintained by Department Regional Offices, concerning
field employees.
(2) The Office of Personnel Management's procedures may, if
necessary, be supplemented in the Food and Drug Administration Staff
Manual Guide. Current Food and Drug Administration employees should mail
or deliver written requests under the Privacy Act for access to
personnel records described in this paragraph to the Office of Personnel
Management in accordance with 5 CFR 297.106, the Director, Division of
Human Resources Management (HFA-400), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, or the personnel officer in the
servicing HHS Regional Personnel Office. An employee may consult with or
direct his or her request to the FDA Privacy Act Coordinator (HFI-30).
Requests for access to personnel records of former employees that are
located in Federal Records Centers should be directed to the Office of
Personnel Management. Requests under the Privacy Act for amendment of
personnel records should be directed to these same officials who are
responsibile for access to personnel records under this paragraph.
(3) With respect to records subject to paragraph (b)(1) of this
section:
(i) Refusal to grant access to a record, or refusal to amend a
record upon request of an employee, shall only be made by the Associate
Commissioner for Management and Operations or his or her designate; and
(ii) Appeals of refusals under paragraph (b)(3)(i) of this section
may be made to the Office of Personnel Management in accordance with 5
CFR 297.108(g)(3) and 297.113(b).
(c) Any other Privacy Act Record Systems that contain personnel
records, or records that otherwise concern agency employees, that are
maintained by offices of the Food and Drug Administration rather than
the Division of Human Resources Management but which are not subject to
the Department's notice for personnel records in operating offices are
subject to this part, except that refusals under this part to grant
access to or amend records about present or former employees shall be
made by the Associate Commissioner for Management and Operations rather
than the Associate Commissioner for Public Affairs.
(d) The following procedures shall govern requests under the Privacy
Act for personnel records that are maintained by the operating offices
of the Food and Drug Administration in which employees work:
(1) An employee shall upon request be told whether records about him
are maintained. An employee shall be given access to records about
himself that are subject to this paragraph in response to an oral or
written request and through informal procedures, rather than the
procedures specified in Sec. Sec. 21.40 through 21.43.
(2) Employee identity may be verified, if necessary, by an FDA ID
card rather than in accordance with Sec. 21.44.
(3) Generally no fee shall be charged for records requested under
this paragraph. However, in cases where the records requested are
voluminous, a fee may be charged in accordance with Sec. 21.45.
(4) Records that are subject to this paragraph shall be available
for access to an individual, except to the extent that access is refused
by the Associate Commissioner for Management and Operations or his or
her designate on the
[[Page 224]]
grounds that the record is subject to an exemption under Sec. 21.61 or
5 CFR 297.111.
(5) Requests under the Privacy Act for amendment of records subject
to this paragraph should be directed to the Director, Division of Human
Resources Management (HFA-400). Such requests shall be reviewed in
accordance with subpart E of this part. Refusal to amend a record
subject to this paragraph (d)(5) shall only be made by the Associate
Commissioner for Management and Operations or his or her designate.
(6) Appeals of refusals under paragraph (d) (4) or (5) of this
section may be made to the Commissioner of Food and Drugs, except where
the Associate Commissioner for Management and Operations or his or her
designate indicates with his or her refusal that the appeal should be
made to the Office of Personnel Management.
(7) Disclosures of records subject to this paragraph are subject to
subpart G of this part.
[42 FR 15626, Mar. 22, 1977, as amended at 46 FR 8457, Jan. 27, 1981; 50
FR 52278, Dec. 23, 1985]
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