Title 21

SECTION 21.43

21.43 Access to requested records.

§ 21.43 Access to requested records.

(a) Access may be granted to requested records by:

(1) Mailing a copy of the records to the requesting individual, or

(2) Permitting the requesting individual to review the records in person between 9 a.m. and 4 p.m. at the office of the FDA Privacy Act Coordinator, at the Division of Freedom of Information Public Reading Room (address is located on the agency's web site at http://www.fda.gov), or at any Food and Drug Administration field office, listed in part 5, subpart M of this chapter, or at another location or time upon which the Food and Drug Administration and the individual agree. Arrangement for such review can be made by consultation between the FDA Privacy Act Coordinator and the individual. An individual seeking to review records in person shall generally be permitted access to the file copy, except that where the records include nondisclosable information, a copy shall be made of that portion of the records, with the nondisclosable information blocked out. Where the individual is not given a copy of the record to retain, no charge shall be made for the cost of copying a record to make it available to an individual who reviews a record in person under this paragraph.

(b) An individual may request that a record be disclosed to or discussed in the presence of another individual, such as an attorney. The individual may be required to furnish a written statement authorizing the disclosure or discussion in such other individual's presence.

(c) The Food and Drug Administration will make every reasonable effort to assure that records made available under this section can be understood by the individual, such as by providing an oral or written explanation of the records.

[42 FR 15626, Mar. 22, 1977, as amended at 46 FR 8458, Jan. 27, 1981; 69 FR 17290, Apr. 2, 2004; 76 FR 31470, June 1, 2011; 79 FR 68115, Nov. 14, 2014]

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