[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR21.43]
[Page 227]
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:
(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 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]
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