[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: 21CFR14.1]
[Page 137.138]
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. 14.1 Scope.
(a) This part governors the procedures when any of the following
applies:
(1) The Commissioner concludes, as a matter of discretion, that it
is in the public interest for a standing or ad hoc policy or technical
public advisory committee (advisory committee or committee) to hold a
public hearing and to review and make recommendations on any matter
before FDA and for interested persons to present information and views
at an oral public hearing before the advisory committee.
(2) Under specific provisions in the act or other sections of this
chapter, a matter is subject to a hearing before an advisory committee.
The specific provisions are--
(i) Section 14.120 on review of a performance standard for an
electronic product by the Technical Electronic Product Radiation Safety
Standards Committee (TEPRSSC);
(ii) Section 14.140 on review of the safety of color additives;
(iii) Section 14.160 on review of the safety and effectiveness of
human prescription drugs;
(iv) Section 330.10 on review of the safety and effectiveness of
over-the-counter drugs;
(v) Section 601.25 on review of the safety and effectiveness of
biological drugs;
(vi) Part 860, on classification of devices;
(vii) Section 514(g)(5) of the act on establishment, amendment, or
revocation of a device performance standard;
(viii) Section 515 of the act on review of device premarket approval
applications and product development protocols; and
(ix) Section 520(f) of the act on review of device good
manufacturing practice regulations.
(3) A person who has a right to an opportunity for a formal
evidentiary public hearing under part 12 waives that opportunity and
instead under Sec. 12.32 requests a hearing before an advisory
committee, and the Commissioner, as a matter of discretion, accepts the
request.
(b) In determining whether a group is a public advisory committee as
defined in Sec. 10.3(a) and thus subject to this part and to the
Federal advisory Committee Act, the following guidelines will be used:
(1) An advisory committee may be a standing advisory committee or an
ad hoc advisory committee. All standing advisory committees are listed
in Sec. 14.100.
(2) An advisory committee may be a policy advisory committee or a
technical advisory committee. A policy advisory committee advises on
broad and general matters. A technical advisory committee advises on
specific technical or scientific issues, which may relate to regulatory
decisions before FDA.
(3) An advisory committee includes any of its subgroups when the
subgroup is working on behalf of the committee. Section 14.40(d)
describes when a subgroup will be established as an advisory committee
separate from the parent committee.
(4) A committee composed entirely of full-time Federal Government
employees is not an advisory committee.
(5) An advisory committee ordinarily has a fixed membership, a
defined purpose of providing advice to the agency on a particular
subject, regular or periodic meetings, and an organizational structure,
for example, a chairman and staff, and serves as a source of independent
expertise and advice rather than as a representative of or advocate for
any particular interest. The following groups are not advisory
committees:
(i) A group of persons convened on an ad hoc basis to discuss a
matter of current interest to FDA, but which has no continuing function
or organization and does not involve substantial special preparation.
(ii) A group of two or more FDA consultants meeting with the agency
on an ad hoc basis.
(iii) A group of experts who are employed by a private company or a
trade
[[Page 138]]
association which has been requested by FDA to provide its views on a
regulatory matter pending before FDA.
(iv) A consulting firm hired by FDA to provide advice regarding a
matter.
(6) An advisory committee that is utilized by FDA is subject to this
subpart even though it was not established by FDA. In general, a
committee is utilized when FDA requests advice or recommendations from
the committee on a specific matter in order to obtain an independent
review and consideration of the matter, and not when FDA is merely
seeking the comments of all interested persons or of persons who have a
specific interest in the matter.
(i) A committee formed by an independent scientific or technical
organization is utilized if FDA requests advice of that committee rather
than of the parent organization, or if the circumstances show that the
advice given is that of the committee and not of the parent
organization. A committee formed by an independent scientific or
technical organization is not utilized if FDA requests advice of the
organization rather than of a committee and if the recommendations of
any committee formed in response to the request are subject to
substantial independent policy and factual review by the governing body
of the parent organization.
(ii) A committee is not utilized by FDA if it provides only
information, as contrasted with advice or opinions or recommendations.
(iii) FDA is charged with seeking out the views of all segments of
the public on enforcement of the laws administered by the Commissioner.
The fact that a group of individuals or a committee meets regularly with
FDA, for example, a monthly meeting with consumer representatives, does
not make that group or committee an advisory committee. Thus, this
subpart does not apply to routine meetings, discussions, and other
dealings, including exchanges of views, between FDA and any committee
representing or advocating the particular interests of consumers,
industry, professional organizations, or others.
(7) The inclusion of one or two FDA consultants who are special
Government employees on an internal FDA committee does not make that
committee an advisory committee.
(8) A Public Board of Inquiry established under part 13, or other
similar group convened by agreement between the parties to a regulatory
proceeding pending before FDA to review and prepare an initial decision
on the issues in lieu of a formal evidentiary public hearing, is acting
as an administrative law tribunal and is not an advisory committee.
(9) An open public conference or meeting conducted under Sec.
10.65(b) is not an advisory committee meeting.
(10) An FDA committee that primarily has operational responsibility
rather than that of providing advice and recommendations is not an
advisory committee, for example, the Research Involving Human Subjects
Committee (RIHSC).
(c) This part applies only when a committee convenes to conduct
committee business. Site visits, social gatherings, informal discussions
by telephone or during meals or while traveling or at other professional
functions, or other similar activities do not constitute a meeting.
(d) An advisory committee that is utilized but not established by
FDA is subject to this part only to the extent of such utilization, and
not concerning any other activities of such committee.
(e) Any conference or meeting between an employee of FDA and a
committee or group which is not an advisory committee shall be subject
to Sec. 10.65 or other provisions specifically applicable to the
committee or group, for example, part 13 for a Public Board of Inquiry.
(f) This part applies to all FDA advisory committees, except to the
extent that specific statutes require otherwise for a particular
committee, for example, TEPRSSC, the Board of Tea Experts, and advisory
committees established under the Medical Device Amendments of 1976.
[44 FR 22351, Apr. 13, 1979, as amended at 54 FR 9035, Mar. 3, 1989]
Back to Top
© 2007 Betterchem Corp.
|
