[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: 21CFR14.140]
[Page 159]
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 H Color Additive Advisory Committees
Sec. 14.140 Establishment of a color additive advisory committee.
The Commissioner will establish a color additive advisory committee
under the following circumstances:
(a) The Commissioner concludes, as a matter of discretion, that it
would be in the public interest for a color additive advisory committee
to review and make recommendations about the safety of a color additive
on which important issues are pending before FDA and for interested
persons to present information and views at an oral public hearing
before a color additive advisory committee.
(b) There is an issue arising under section 721(b)(5)(B) of the act
concerning the safety of a color additive, including its potential or
actual carcinogenicity, that requires the exercise of scientific
judgment and a person who would be adversely affected by the issuance,
amendment, or repeal of a regulation listing a color additive requests
that the matter, or the Commissioner as a matter of discretion
determines that the matter should, be referred to a color additive
advisory committee.
(1) Paragraph (b) does not apply to any issue arising under the
transitional provisions in section 203 of the Color Additive Amendments
of 1960 relating to provisional listing of commercially established
colors. A color additive advisory committee to consider any such matter
will be established under paragraph (a) of this section.
(2) A request for establishment of a color additive advisory
committee is to be made in accordance with Sec. 10.30. The Commissioner
may deny any petition if inadequate grounds are stated for establishing
a color additive advisory committee. A request for establishment of a
color additive advisory committee may not rest on mere allegations or
denials, but must set forth specific facts showing that there is a
genuine and substantial issue of fact that requires scientific judgment
and justifies a hearing before a color additive advisory committee. When
it conclusively appears from the request for a color additive advisory
committee that the matter is premature or that it does not involve an
issue arising under section 721(b)(5)(B) of the act or that there is no
genuine and substantial issue of fact requiring scientific judgment, or
for any other reason a color additive advisory committee is not
justified, the Commissioner may deny the establishment of a color
additive advisory committee.
(3) Establishment of a color additive advisory committee on the
request of an interested person is conditioned upon receipt of the
application fee specified in Sec. 14.155.
(4) Any person adversely affected may request referral of the matter
to a color additive advisory committee at any time before, or within 30
days after, publication of an order of the Commissioner acting upon a
color additive petition or proposal.
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