[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: 21CFR20.81]
[Page 205]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
PART 20 PUBLIC INFORMATION--Table of Contents
Subpart E Limitations on Exemptions
Sec. 20.81 Data and information previously disclosed to the public.
(a) Any Food and Drug Administration record that is otherwise exempt
from public disclosure pursuant to subpart D of this part is available
for public disclosure to the extent that it contains data or information
that have previously been disclosed in a lawful manner to any member of
the public, other than an employee or consultant or pursuant to other
commerical arrangements with appropriate safeguards for secrecy.
(1) For purposes of this section, an individual shall be deemed to
be a consultant only if disclosure of the information was necessary in
order to perform that specific consulting service and the purpose of the
disclosure was solely to obtain that service. The number of consultants
who have received such information shall have been limited to the number
reasonably needed to perform that particular consulting service.
(2) For purposes of this section, other commercial arrangements
shall include licenses, contracts, and similar legal relationships
between business associates.
(3) For purposes of this section, data and information disclosed to
clinical investigators or members of institutional review committees,
whether required by regulations of the Food and Drug Administration, or
made voluntarily, if accompanied by appropriate safeguards to assure
secrecy and otherwise in accordance with this section, are not deemed to
have been previously disclosed to any member of the public within the
meaning of paragraph (a) of this section.
(b) Any statement relating to prior public disclosure is subject to
the False Reports to the Government Act, 18 U.S.C. 1001.
[42 FR 15616, Mar. 22, 1977, as amended at 54 FR 9038, Mar. 3, 1989; 59
FR 536, Jan. 5, 1994; 68 FR 25287, May 12, 2003]
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