[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: 21CFR21.40]
[Page 224-225]
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. 21.40 Procedures for submitting requests for notification and access.
(a) An individual may request that the Food and Drug Administration
notify him whether a Privacy Act Record System contains records about
him that are retrieved by reference to his name or other personal
identifier. An individual may at the same time, or after receiving
notification that such a record about him exists, requests that he be
given access to the record.
(b) An individual desiring notification or access to records shall
mail or deliver a request for records in any Food and Drug
Administration Privacy Act Records System to the FDA Privacy Act
Coordinator (HFI-30), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857.
(c) Requests shall be in writing and shall name the Privacy Act
Record System or Systems concerning which the individual requests
notification of whether there are records about him that are retrieved
by reference to his name or other personal identifier. To help assure a
prompt response, an individual should indicate that he is making a
``Privacy Act Request'' on the envelope and in a prominent manner in the
letter.
(d) An individual who merely wishes to be notified whether a Privacy
Act Record System contains a record about him ordinarily need not
provide any verification of his identity other than his name. The mere
fact that the Food and Drug Administration has a record about an
individual in any of its Privacy Act Records Systems would not be likely
to constitute a clearly unwarranted invasion of personal privacy. Where
mere disclosure of the fact that a record about the individual exists
[[Page 225]]
would be a clearly unwarranted invasion of personal privacy, further
verification of the identity of the individual shall be required.
(e) An individual who requests that he be given access to a copy of
records about himself, if any exist, should indicate whether he prefers
(1) to have copies of any such records mailed to him in accordance with
Sec. 21.43(a)(1), which may involve a fee under Sec. 21.45, including
information to verify his identity under Sec. 21.44 or (2) to use the
procedures for access in person under Sec. 21.43(a)(2).
(f) A request for notification and access may be submitted under
this subpart concerning any Privacy Act Record System that is exempt
under Sec. 21.61, as indicated in the notice for the system. An
individual seeking access to records under Sec. 21.65(b)(2) to
investigatory records compiled for law enforcement purposes other than
criminal law enforcement purposes should submit a description of the
right, benefit, or privilege that he believes he was denied as the
result of the Food and Drug Administration's maintenance of the records.
Where the system is exempt under Sec. 21.61, and access to the
requested records is not granted under Sec. 21.65, the request shall be
handled under the provisions of part 20 of this chapter (the public
information regulations).
[42 FR 15626, Mar. 22, 1977, as amended at 46 FR 8458, Jan. 27, 1981; 50
FR 52278, Dec. 23, 1985]
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