§21.41. Processing of requests. — 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.

(e) A letter in accordance with § 21.42 responding to the request for notification shall issue as promptly as possible after receipt of the request by the Food and Drug Administration. Upon determination by the Division of Freedom of Information (address is located on the agency web site at http://www.gov.fda) that a request for access to records is appropriately treated as a request under part 20 of this chapter rather than part 21, or under both parts, the time limitations prescribed in § 21.41 shall apply. In any case, access to available records shall be provided as promptly as possible.

(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

(3) If the named Privacy Act Record System contains records about the individual that are retrieved by his name or other personal identifier, and the system is exempt from individual access and contest under § 21.61 and access is not allowed or required under § 21.65, the letter should inform him that the records are exempted from access and contest by § 21.61. The letter shall also inform him if the records sought are not available because they were compiled in reasonable anticipation of court litigation or formal administrative proceedings or are otherwise not available under § 21.41(b). Where appropriate, the letter shall also indicate whether the records are available under part 20 of this chapter (the public information regulations), and it may disclose the records in accordance with part 20.

(2) The availability of the record may be subject to any procedures for disclosure to an individual of medical records about himself under part 20 of this chapter, in addition to or in lieu of the procedures in paragraph (b)(1), that are not inconsistent with § 21.41(f).