Code of Federal Regulations Title 21. Food and Drugs § 21.21.43 Access to requested records

(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.