[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: 21CFR20.81]

[Page 212]
 
                        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 data or information furnished to the Food and Drug 
Administration for a presubmission review pursuant to the procedure 
established in Sec. 20.44 shall be accompanied by a statement that the 
information has not previously been published or disclosed to anyone 
other than as provided in paragraph (a) of this section.
    (c) 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]