[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR21.32]

[Page 228-230]
 
                        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

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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 Secs. 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 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

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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]