§21.50. Procedures for submitting requests for amendment of records. — Inbound Citations

(b) In any subsequent disclosure under § 21.70 or § 21.71(a), provide a copy of the statement of disagreement and, if the Food and Drug Administration deems it appropriate, a concise statement of the agency's reasons for not making the amendment(s) requested. While the individual shall have access to any such statement, it shall not be subject to a request for amendment under § 21.50.

(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