[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR21.43]

[Page 233-234]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                                SERVICES
 
PART 21--PROTECTION OF PRIVACY--Table of Contents
 
   Subpart D--Procedures for Notification of and Access to Records in 
                       Privacy Act Record Systems
 
Sec. 21.43  Access to requested records.

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

[[Page 234]]

    (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 Freedom of Information Staff Public Room at the 
address shown in Sec. 20.30 of this chapter, or at any Food and Drug 
Administration field office listed in Sec. 5.115 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]