§21.44. Verification of identity. — Inbound Citations

(2) Employee identity may be verified, if necessary, by an FDA ID card rather than in accordance with § 21.44.

(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 § 21.43(a)(1), which may involve a fee under § 21.45, including information to verify his identity under § 21.44 or (2) to use the procedures for access in person under § 21.43(a)(2).

(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

(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.

(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.

(1) May be given access to the records where available under part 20 of this chapter (the public information regulations) or the Commissioner may, in his discretion, entertain a request under any or all of the provisions of §§ 21.40 through 21.54; and

(b) In each case the consent shall be in writing and shall specify the individual, organizational unit, or class of individuals or organizational units to whom the record may be disclosed, which record may be disclosed, and, if applicable, for what time period. A blanket consent to release all of an individual's records to unspecified individuals or organizational units will not be honored. Verification of the identity of the individual and, where applicable, of the person to whom the record is to be disclosed shall be made in accordance with § 21.44. Consent documents shall be retained for a period of at least 2 years. If such documents are used as a means of accounting for the disclosure, they shall be retained as provided in § 21.71(e)(2).

(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 § 21.43(a)(1), which may involve a fee under § 21.45, including information to verify his identity under § 21.44 or (2) to use the procedures for access in person under § 21.43(a)(2).