[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2004]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR20.90]

[Page 239]
 
                        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. 20.90  Disclosure to contractors.

    (a) Data and information otherwise exempt from public disclosure may 
be disclosed to contractors with the Food and Drug Administration and 
their employees for use only in their work for the Food and Drug 
Administration. Contractors and their employees are thereafter subject 
to the same legal restrictions and penalties with respect to the 
disclosure of such data and information as Food and Drug Administration 
employees.
    (b) A written agreement between the Food and Drug Administration and 
any contractor shall be entered into before data and information 
otherwise exempt from public disclosure may be disclosed to the 
contractor. The contractor shall agree to establish and follow security 
precautions considered by the Food and Drug Administration to be 
necessary to ensure proper and confidential handling of the data and 
information. The written agreement shall include, where appropriate, 
provisions establishing:
    (1) Restrictions on access to the data and information by the 
contractor, its employees, or other persons;
    (2) Physical storage requirements;
    (3) Requirements for the handling and accountability of the data and 
information by the contractor and its employees;
    (4) Limitations on reproduction, transmission, and disclosure of the 
data and information;
    (5) A requirement of advance approval by the Food and Drug 
Administration of the use by the contractor of subcontractors, vendors, 
or suppliers;
    (6) Procedures to be followed when the contractor employs time-
shared computer operations;
    (7) Methods of destroying source documents or related waste 
material; and
    (8) The period during which the contractor may retain such data and 
information.