[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: 21CFR20.90]
[Page 210]
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.
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