§21.40. Procedures for submitting requests for notification and access. — Inbound Citations

(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 §§ 21.40 through 21.43.

(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.

(a) Where a Privacy Act Record System is exempt and the requested records are unavailable under § 21.61, an individual may nevertheless make a request under § 21.40 for notification concerning whether any records about him exist and request access to such records where they are retrieved by his name or other personal identifier.

(c) Requests to amend records shall be submitted, in writing, to the FDA Privacy Act Coordinator in accordance with § 21.40(b). Such requests shall include information sufficient to enable the Food and Drug Administration to locate the record, a brief description of the items of information requested to be amended, and the reasons why the record should be amended together with any appropriate documentation or arguments in support of the requested amendment. An edited copy of the record showing the described amendment may be included. Verification of identity should be provided in accordance with § 21.44.