§21.61. Exempt systems. — Inbound Citations

(1) The availability to an individual, as defined in § 21.3(a), of a record about himself that is retrieved by the individual's name or other personal identifier and is contained in a Privacy Act Record System shall be subject to the special requirements of part 21 of this chapter (the privacy regulations) and shall not be subject to the exemptions in subpart D of this part except that where the system is exempt and the requested record is not available under § 21.61 of this chapter, the provisions of this part shall apply.

(10) Where any records in the system are subject to an exemption under § 21.61, a reference to this exemption.

(4) Records that are subject to this paragraph shall be available for access to an individual, except to the extent that access is refused by the Associate Commissioner for Management and Operations or his or her designate on the grounds that the record is subject to an exemption under § 21.61 or 5 CFR 297.111.

(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.

(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.

(4) Except when the record is exempt from individual access and contest under § 21.61 or to the extent that the accounting describes a transfer for a law enforcement purpose pursuant to paragraph (a)(7) of this section, make the accounting available to the individual to whom the record pertains, in accordance with procedures of subpart D of this part.