§21.65. Access to records in exempt systems. — Inbound Citations

(f) A request for notification and access may be submitted under this subpart concerning any Privacy Act Record System that is exempt under § 21.61, as indicated in the notice for the system. An individual seeking access to records under § 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 § 21.61, and access to the requested records is not granted under § 21.65, the request shall be handled under the provisions of part 20 of this chapter (the public information regulations).

(2) If there are records about the individual that are retrieved by his name or other personal identifier and the named Privacy Act Record System is not exempt from individual access and contest under § 21.61, or the system is exempt but access is allowed or required under § 21.65, the letter shall inform him that the records exist and shall either:

(i) Enclose a copy of the records under § 21.43(a)(1) or indicate that the records will be sent under separate cover, where there has been adequate verification of the identity of the individual under § 21.44 and the fees under § 21.45 do not exceed $25, or

(ii) Inform the individual of the procedures to obtain access to the records by mail or in person under § 21.43(a)(2), as well as the approximate dates by which the requested records can be provided (if the records are not then available), the locations at which access in person may be had, and the information needed, if any, to verify the identity of the individual under § 21.44.

(f) Except as provided in § 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 § 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.

(2) Except where access is required under 5 U.S.C. 552a(k)(2) and § 21.65(a)(2), (such records are exempt from 5 U.S.C. 552a(d)(1) through (4) and (f)) and §§ 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.

(f) A request for notification and access may be submitted under this subpart concerning any Privacy Act Record System that is exempt under § 21.61, as indicated in the notice for the system. An individual seeking access to records under § 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 § 21.61, and access to the requested records is not granted under § 21.65, the request shall be handled under the provisions of part 20 of this chapter (the public information regulations).