[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: 21CFR14.15]
[Page 139.140]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
PART 14 PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE--Table of Contents
Subpart A General Provisions
Sec. 14.15 Committees working under a contract with FDA.
(a) FDA may enter into contracts with independent scientific or
technical organizations to obtain advice and recommendations on
particular matters, and these organizations may in turn undertake such
work through existing or new committees. Whether a particular committee
working under such a contract is an advisory committee subject to the
Federal Advisory Committee Act and this subpart depends upon application
of the criteria and principles in Sec. 14.1(b).
(b) The following minimum standards apply to any committee of an
independent scientific or technical organization which is working under
a contract initially executed with FDA after July 1, 1975, but which is
determined not to be an advisory committee:
(1) The committee shall give public notice of its meetings and
agenda, and provide interested persons an opportunity to submit relevant
information and views in writing at any time, and orally at specified
times. The notice may be published in the Federal Register or
disseminated by other reasonable means. It is in any event to be filed
with the Division of Dockets Management not less than 15 days before the
meeting. The time for oral presentations and the extent to which the
committee meets in open session other than for such oral presentations
is in the discretion of the committee.
(2) Minutes of open sessions are to be maintained, with all written
submissions attached which were made to the committee in open session.
After approval, the minutes are to be forwarded to the Division of
Dockets Management and placed on public display. The extent to which the
committee maintains minutes of closed sessions is in the discretion of
the committee.
[[Page 140]]
(3) In selecting the members of the committee, the organization
involved is to apply the principles relating to conflicts of interest
that FDA uses in establishing a public advisory committee. Those
principles are set out or cross-referenced in this part and in part 19.
Upon request, FDA will assist or provide guidance to any organization in
meeting this requirement.
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