[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: 21CFR21.41]
[Page 225-226]
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 D Procedures for Notification of and Access to Records in
Privacy Act Record Systems
Sec. 21.41 Processing of requests.
(a) An individual or his guardian under Sec. 21.75 shall not be
required to show any justification or need to obtain notification under
Sec. 21.42 or access to a record under Sec. 21.43.
(b) The Food and Drug Administration will determine whether a
request by an individual for records about himself is appropriately
treated as a request under this subpart, or under the provision of part
20 of this chapter (the public information regulations), or both. Where
appropriate, the Food and Drug Administration will consult with the
individual concerning the appropriate treatment of the request.
(c) The FDA Privacy Act Coordinator (HFI-30) in the Freedom of
Information Staff shall be responsibile for the handling of Privacy Act
requests received by the Food and Drug Administration. Requests mailed
or delivered to any other office shall be promptly redirected to the FDA
Privacy Act Coordinator. Where this procedure would unduly delay the
agency's response, however, the agency employee who received the request
should consult with the FDA Privacy Act Coordinator and obtain advice as
to whether the employee can respond to the request directly.
(d) Upon receipt of a request by the FDA Privacy Act Coordinator, a
record shall promptly be made that a request has been received and the
date.
(e) A letter in accordance with Sec. 21.42 responding to the
request for notification shall issue as promptly as possible after
receipt of the request by the Food and Drug Administration. Upon
determination by the Freedom of Information Staff that a request for
access to records is appropriately treated as a request under part 20 of
this chapter rather than part 21, or under both parts, the time
limitations prescribed in Sec. 21.41 shall apply. In any case, access
to available records shall be provided as promptly as possible.
(f) Except as provided in Sec. 21.32, an individual's access to
records about him/herself that are retrieved by his/her name or other
personal identifiers and contained in any Privacy Act Record System may
only be denied by the Associate Commissioner for Public Affairs or his
or her designate. An individual shall not be denied access to any record
that is otherwise available to him/her under this part except on the
grounds that it is exempt under Sec. 21.65(a)(2), that it was compiled
in reasonable anticipation of court litigation of formal administrative
proceedings, or to the extent that it is exempt or prohibited from
disclosure because it includes a trade secret or commercial or financial
information that is privileged or confidential information the
disclosure of which would constitute a clearly unwarranted invasion of
personal privacy of another individual.
(g) The FDA Privacy Act Coordinator shall ensure that records are
maintained of the number, status, and disposition of requests under this
subpart, including the number of requests for
[[Page 226]]
records exempt from access under this subpart and other information
required for purposes of the annual report to Congress under the Privacy
Act. These temporary administrative management records shall not be
considered to be Privacy Act Record Systems. All records required to be
kept under this paragraph shall only include requesting individuals'
names or personal identifiers for so long as any request for
notification, access, or amendment is pending. The identity of
individuals making request under this subpart shall be regarded as
confidential and shall not be disclosed under part 20 of this chapter
(the public information regulations) to any other person or agency
except as is necessary for the processing of requests under this
subpart.
[42 FR 15626, Mar. 22, 1977, as amended at 46 FR 8458, Jan. 27, 1981]
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