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[Code of Federal Regulations] |
[Title 21, Volume 1] |
[Revised as of April 1, 2004] |
[CITE: 21CFR14] |
TITLE 21--FOOD AND DRUGS
SUBCHAPTER A - GENERAL
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PART 14 | PUBLIC HEARING BEFORE A PUBLIC ADVISORY
COMMITTEE
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Subpart A -- General Provisions
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(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
§ 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 § 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
§ 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
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
§ 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 § 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]
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Sec. 14.5 Purpose of proceedings before an advisory committee.
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(a) An advisory committee is utilized to conduct public hearings on matters
of importance that come before FDA, to review the issues involved, and to
provide advice and recommendations to the Commissioner.
(b) The Commissioner has sole discretion concerning action to be taken and
policy to be expressed on any matter considered by an advisory committee.
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Sec. 14.7 Administrative remedies.
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A person who alleges noncompliance by the Commissioner or an advisory
committee with any provision of this part or the Federal Advisory Committee Act
may pursue the following administrative remedies:
(a) If the person objects to any action, including a failure to act, other
than denial of access to an advisory committee document, the person shall submit
a petition in the form and in accordance with the requirements of
§ 10.30. The provisions of § 10.45 relating to exhaustion
of administrative remedies are applicable.
(1) If the person objects to past action, the person shall submit the
petition within 30 days after the action objected to. If the Commissioner
determines that there was noncompliance with any provision of this subpart or of
the Federal Advisory Committee Act, the Commissioner will grant any appropriate
relief and take appropriate steps to prevent its future recurrence.
(2) If the person objects to proposed future action, the Commissioner will
expedite the review of the petition and make a reasonable effort to render a
decision before the action concerned in the petition.
(3) If the person objects to action that is imminent or occurring and which
could not reasonably have been anticipated, e.g., the closing of a portion of a
meeting which is made known for the first time on the day of the meeting, the
matter may be handled by an oral petition in lieu of a written petition.
(b) If the person objects to a denial of access to an advisory committee
document, administrative review is in accordance with the procedures established
by the Department of Health and Human Services under 45 CFR 5.34.
[44 FR 22351, Apr. 13, 1979, as amended at 55 FR 1404, Jan. 16, 1990]
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Sec. 14.10 Applicability to Congress.
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This part applies to Congress, individual Members of Congress, and other
employees or representatives of Congress in the same way that they apply to any
other member of the public, except that disclosure of advisory committee records
to Congress is governed by § 20.87.
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Sec. 14.15 Committees working under a contract with FDA.
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(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
§ 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.
(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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Subpart B -- Meeting Procedures
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Sec. 14.20 Notice of hearing before an advisory committee.
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(a) Before the first of each month, and at least 15 days in advance of a
meeting, the Commissioner will publish a notice in the Federal
Register of all advisory committee meetings to be held during the month. Any
advisory committee meetings for that month called after the publication of the
general monthly notice are to be announced in the Federal Register
on an individual basis at least 15 days in advance. The Commissioner may
authorize an exception to these notice requirements in an emergency or for other
reasons requiring an immediate meeting of an advisory committee, in which case
public notice will be given at the earliest time and in the most accessible form
feasible including, whenever possible, publication in the Federal
Register.
(b) The Federal Register notice will include—
(1) The name of the committee;
(2) The date, time, and place of the meeting;
(3) The general function of the committee;
(4) A list of all agenda items, showing whether each will be discussed in an
open or closed portion of the meeting;
(5) If any portion of the meeting is closed, a statement of the time of the
open and closed portions;
(6) The nature of the subjects to be discussed during, and the reasons for
closing, any closed portion of the meeting;
(7) The time set aside for oral statements and other public participation;
(8) The name, address, and telephone number of the advisory committee
executive secretary and any other agency employee designated as responsible for
the administrative support for the advisory committee;
(9) A statement that written submissions may be made to the advisory
committee through the executive secretary at any time, unless a cutoff date has
been established under § 14.35(d)(2);
(10) When a notice is published in the Federal Register less
than 15 days before a meeting, an explanation for the lateness of the notice;
and
(c) If a public hearing before an advisory committee is used in lieu of a
formal evidentiary public hearing under § 14.1(a)(3), an initial
notice of hearing is to be published separately in the Federal
Register containing all the information described in § 12.32(e).
This procedure may be used for any other hearing before an advisory committee
when the Commissioner concludes, as a matter of discretion, that it would be
informative to the public.
(d) A list of advisory committee meetings will be distributed to the press by
the Associate Commissioner for Public Affairs.
[44 FR 22351, Apr. 13, 1979, as amended at 47 FR 26375, June 1, 1982; 54
FR 9035, Mar. 3, 1989; 66 FR 6469, Jan. 22, 2001; 66 FR 12850, Mar. 1, 2001]
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Sec. 14.22 Meetings of an advisory committee.
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(a) No advisory committee may conduct a meeting except at the call or with
the advance approval of, and with an agenda approved by, the designated Federal
employee or alternate. No meeting may be held in the absence of the designated
Federal employee.
(1) If any matter is added to the agenda after its publication in the Federal Register under § 14.20(b)(4), an attempt is to be
made to inform persons known to be interested in the matter, and the change is
to be announced at the beginning of the open portion of the meeting.
(2) The advisory committee meeting is to be conducted in accordance with the
approved final agenda insofar as practical.
(b) Advisory committee meetings will be held at places that are reasonably
accessible to the public. All advisory committee meetings will be held in
Washington, DC, or Rockville, MD, or the immediate vicinity, unless the
Commissioner receives and approves a written request from the advisory committee
for a different location. A different location may be approved when one or more
of the following applies:
(1) The total cost of the meeting to the Government will be reduced.
(2) A substantial number of the committee members will be at the location at
no expense to FDA for other reasons, e.g., for a meeting of a professional
association.
(3) It is a central location more readily accessible to committee members.
(4) There is a need for increased participation available at that location.
(5) The committee wishes to review work or facilities in a specific location.
(6) The committee is concerned with matters that functionally or historically
occur in some other location, e.g., the Board of Tea Experts and the Science
Advisory Board of the National Center for Toxicological Research will generally
hold meetings in Brooklyn, NY, and in the Little Rock, AR, vicinity,
respectively.
(c) Advisory committee members may, with the approval of FDA, conduct onsite
visits relevant to their work.
(d) Unless the committee charter provides otherwise, a quorum for an advisory
committee is a majority of the current voting members of the committee, except
as provided in § 14.125(c) for TEPRSSC. Any matter before the
advisory committee is to be decided by a majority vote of the voting members
present at the time, except that the designated Federal official may require
that any final report be voted upon by all current voting members of the
committee. Any current voting member of the committee may file a separate report
with additional or minority views.
(e) If space is available, any interested person may attend any portion of
any advisory committee meeting which is not closed.
(f) Whenever feasible, meetings are to be held in government facilities or
other facilities involving the least expense to the public. The size of the
meeting room is to be reasonable, considering such factors as the size of the
committee, the number of persons expected to attend a meeting, and the resources
and facilities available.
(g) The Commissioner may authorize a meeting to be held by conference
telephone call. For these meetings, a speaker phone will be provided in a
conference room located in Washington, DC, or Rockville, MD, or the immediate
vicinity, to permit public participation in open portions of the meetings, as
provided in §§ 14.25 and 14.29. These meetings generally will be
brief, and authorized—
(1) For the purpose of taking final votes or otherwise confirming actions
taken by the committee at other meetings; or
(2) Where time does not permit a meeting to be held at a central location.
(h) Any portion of a meeting will be closed by the committee chairman only
when matters are to be discussed which the Commissioner has determined may be
considered in closed session under § 14.27(b). If a portion of the
meeting is closed, the closed portion will be held after the conclusion of the
open portion whenever practicable.
(i) Any committee member may take notes during meetings and report and
discuss committee deliberations after a meeting is completed and before official
minutes or a report are available, within the rules and regulations adopted by
FDA and by the advisory committee with the concurrence of FDA, including all of
the following:
(1) There may be no attribution of individual views expressed in a closed
session or revealing of numerical votes.
(2) There may be no reporting or discussion of any particular matter if the
committee or FDA specifically so directs, e.g., where deliberations are
incomplete or involve a sensitive regulatory decision that requires preparation
or implementation.
(3) There may be no reporting or discussion of information prohibited from
public disclosure under § 14.75.
(4) Notes or minutes kept or reports prepared by a committee member have no
status or effect unless adopted into the official minutes or report by the
committee. It is the responsibility of each committee member to make certain
that the official minutes and reports are complete and accurate and fully
reflect what happened at any meeting the committee member attended.
[44 FR 22351, Apr. 13, 1979; 48 FR 40887, Sept. 12, 1983, as amended at 54
FR 9035, Mar. 3, 1989]
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Sec. 14.25 Portions of advisory committee meetings.
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An advisory committee meeting has the following portions:
(a) The open public hearing. Every committee meeting includes
an open portion, which constitutes a public hearing during which interested
persons may present relevant information or views orally or in writing. The
hearing is conducted in accordance with § 14.29.
(b) The open committee discussion. A committee discusses any
matter pending before it in an open portion of its meeting unless the meeting
has been closed for that matter under § 14.27. To the maximum extent
feasible, consistent with the policy expressed in § 14.27, a
committee conducts its discussion of pending matters in an open portion. No
public participation is permissible during this portion of the meeting except
with the consent of the committee chairman.
(c) The closed presentation of data. Information prohibited
from public disclosure under part 20 and the regulations referenced therein is
presented to the committee in a closed portion of its meeting. However, if
information is in the form of a summary that is not prohibited from public
disclosure, the presentation is to be made in an open portion of a meeting.
(d) The closed committee deliberations. Deliberations about
matters before an advisory committee may be held in a closed portion of a
meeting only upon an appropriate determination by the Commissioner under
§ 14.27.
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Sec. 14.27 Determination to close portions of advisory committee meetings.
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(a) No committee meeting may be entirely closed. A portion of a meeting may
be closed only in accordance with a written determination by the Commissioner
under this section.
(b) The executive secretary or other designated agency employee shall prepare
the initial request for a determination to close a portion of a meeting,
specifying the matter(s) to be discussed during the closed portion and the
reasons why the portion should be closed. The Commissioner, based upon this
request and with the concurrence of the Chief Counsel, will determine whether to
close a portion of a meeting. The reasons for closing a portion of a meeting
will be announced in the Federal Register notice of the meeting
under § 14.20 in accordance with the following rules:
(1) Any determination to close a portion of a meeting restricts the closing
to the shortest possible time consistent with the policy in this section.
(2) A portion of a meeting may be closed only if the Commissioner determines
that the closing is permitted under 5 U.S.C. 552b(c), and that the closing is
necessary.
(3) Portions of meetings may ordinarily be closed if they concern the review,
discussion, and evaluation of drafts or regulations, guidance documents or
similar preexisting internal agency documents, but only if their premature
disclosure would significantly impede proposed agency action; review of trade
secrets and confidential commercial or financial information; consideration of
matters involving investigatory files compiled for law enforcement purposes; and
review of matters, the disclosure of which would constitute a clearly
unwarranted invasion of personal privacy.
(4) Portions of meetings ordinarily may not be closed if they concern review,
discussion, and evaluation of general preclinical and clinical test protocols
and procedures for a class of drugs or devices; consideration of labeling
requirements for a class of marketed drugs and devices; review of information on
specific investigational or marketed drugs and devices that have previously been
made public; presentation of any other information not exempt from public
disclosure under 5 U.S.C. 552b(c); the formulation of advice and recommendations
to FDA on matters that do not independently justify closing.
(5) No portion of a meeting devoted to matters other than those designated in
paragraph (b) (1) through (3) of this section may be closed.
(6) A matter which is properly considered in an open portion of a meeting may
instead be considered in a closed portion only if it is so inextricably
intertwined with matters to be discussed in a closed portion that it is not
feasible to separate them or discussion of the matter in an open portion would
compromise the matters to be discussed in the closed portion.
(c) Attendance at a closed portion of a meeting is governed by the following
rules:
(1) A portion of a meeting closed for the presentation or discussion of
information that constitutes a trade secret or confidential commercial or
financial information as defined in § 20.61 may be attended only by
voting advisory committee members, nonvoting members representing consumer
interests who are also special government employees as provided in
§ 14.80(b), the executive secretary of the advisory committee, a
transcriber, consultants, and such other regular employees of FDA (including
members of the Office of the Chief Counsel) as the chairman of the advisory
committee may invite, and by those persons authorized to be present under
§ 14.25(c), for presentation of information prohibited from public
disclosure. A person making a presentation described in § 14.25(c)
may be accompanied by a reasonable number of employees, consultants, or other
persons in a commercial arrangement within the meaning of § 20.81(a).
(2) A portion of a meeting that has been closed for consideration of existing
internal agency documents falling within § 20.62 where premature
disclosure is likely to significantly impede proposed agency action; personnel,
medical, and similar files, disclosure of which would be a clearly unwarranted
invasion of personal privacy within the meaning of § 20.63; or
investigatory records compiled for law enforcement purposes as defined in
§ 20.64 may be attended only by committee members (voting and
nonvoting), the executive secretary of the committee, a transcriber, and other
regular employees of FDA (including members of the Office of the Chief Counsel)
whom the chairman of the committee may invite. Consultants, individuals
performing personal service contracts, employees of other Federal agencies, and
the general public may not attend such portions.
(3) If a person other than a person permitted to attend in accordance with
paragraph (c) (1) and (2) of this section attempts to attend a closed portion of
a meeting without the approval of the executive secretary and the chairman, and
the matter is brought to their attention, the person will be required to leave
the meeting immediately. This inadvertent and unauthorized attendance does not
enable other unauthorized persons to attend, nor does it, of itself, constitute
grounds for release of transcripts of closed portions or any other documents
otherwise exempt from disclosure under § 14.75 and part 20.
(4) If a person other than a person permitted to attend in accordance with
paragraphs (c) (1) and (2) of this section is allowed by the executive secretary
and the chairman to attend a closed portion of a meeting, that portion is open
to attendance by any interested person.
[44 FR 22351, Apr. 13, 1979, as amended at 65 FR 56479, Sept. 19, 2000]
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Sec. 14.29 Conduct of a hearing before an advisory committee.
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(a) For each meeting, the open portion for public participation, which
constitutes a public hearing under § 14.25(a), will be at least 1
hour, unless public participation does not last that long, and may last for
whatever longer time the committee chairman determines will facilitate the work
of the committee. The Federal Register notice published under
§ 14.20 will designate the time specifically reserved for the
hearing, which is ordinarily the first portion of the meeting. Further public
participation in any open portion of the meeting under § 14.25(b) is
solely at the discretion of the chairman.
(b) An interested person who wishes to be assured of the right to make an
oral presentation at a meeting shall inform the executive secretary or other
designated agency employee, orally or in writing, before the meeting.
(1) The person shall state the general nature of the presentation and the
approximate time desired. Whenever possible, all written information to be
discussed by that person at the meeting should be furnished in advance to the
executive secretary or other designated agency employee. This material may be
distributed or mailed by FDA to the committee members in advance of the meeting
if time permits, and otherwise will be distributed to the members when they
arrive for the meeting. The mailing or distribution may be undertaken only by
FDA unless FDA grants permission to a person to mail or distribute the material
(2) Before the meeting, the executive secretary or other designated agency
employee shall determine the amount of time allocated to each person for oral
presentation and the time that the presentation is to begin. Each person will be
so informed in writing, if time permits, or by telephone. FDA may require
persons with common interests to make joint presentations.
(c) The chairman of the committee shall preside at the meeting in accordance
with § 14.30 and be accompanied by other committee members, who serve
as a panel in conducting the hearing portion of the meeting.
(d) Each person may use the allotted time as desired, consistent with an
orderly hearing. A person may be accompanied by additional persons, and may
present any written information or views for inclusion in the record of the
hearing, subject to the requirements of § 14.35(c).
(e) If a person is absent at the time specified for that person`s
presentation, the persons following will appear in order. An attempt will be
made to hear the person at the conclusion of the hearing. Interested persons
attending the hearing who did not request an opportunity to make an oral
presentation may be given an opportunity to do so at the discretion of the
chairman.
(f) The chairman and other members may question a person concerning that
person`s presentation. No other person, however, may question the person. The
chairman may allot additional time when it is in the public interest, but may
not reduce the time allotted without consent of the person.
(g) Participants may question a committee member only with that member`s
permission and only about matters before the committee.
(h) The hearing is informal, and the rules of evidence do not apply. No
motions or objections relating to the admissibility of information and views may
be made or considered, but other participants may comment upon or rebut matters
presented. No participant may interrrupt the presentation of another
participant.
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Sec. 14.30 Chairman of an advisory committee.
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(a) The advisory committee chairman has the authority to conduct hearings and
meetings, including the authority to adjourn a hearing or meeting if the
chairman determines that adjournment is in the public interest, to discontinue
discussion of a matter, to conclude the open portion of a meeting, or to take
any other action to further a fair and expeditious hearing or meeting.
(b) If the chairman is not a full-time employee of FDA, the executive
secretary or other designated agency employee, or alternate, is to be the designated Federal employee who is assigned to the advisory
committee. The designated Federal employee is also authorized to adjourn a
hearing or meeting if the employee determines adjournment to be in the public
interest.
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Sec. 14.31 Consultation by an advisory committee with other persons.
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(a) A committee may confer with any person who may have information or views
relevant to any matter pending before the committee.
(b) An interested person may submit to the committee a written request that
it confer with specific persons about any matter pending before the committee.
The request is to contain adequate justification. The committee may, in its
discretion, grant the request.
(c) A committee may confer with a person who is not a Federal Government
executive branch employee only during the open portions of a meeting. The person
may, however, submit views in writing to the committee as part of the
administrative record under § 14.70. The person may participate at
the closed portions of a meeting only if appointed as a special Government
employee by the Commissioner as provided in paragraph (e) of this section. This
paragraph (c) is not intended to bar the testimony of a person during a closed
portion of a meeting about matters prohibited from public disclosure under
§§ 14.25(c) and 14.27(c).
(d) To prevent inadvertent violation of Federal conflict of interest laws and
laws prohibiting disclosure of trade secrets (18 U.S.C. 208, 21 U.S.C. 331(j),
18 U.S.C. 1905), Federal executive branch employees who are not employees of the
Department may not confer, testify, or otherwise participate (other than as
observers) at any portion of an advisory committee meeting unless they are
appointed as special Government employees by the Commissioner under paragraph
(e) of this section. this paragraph does not apply to Federal executive branch
employees who are appointed as members of TEPRSSC, as provided in
§ 14.127.
(e) The Commissioner may appoint persons as special Government employees to
be consultants to an advisory committee. Consultants may be appointed to provide
expertise, generally concerning a highly technical matter, not readily available
from the members of the committee. Consultants may be either from outside the
Government or from agencies other than the Food and Drug Administration.
Reports, data, information, and other written submissions made to a public
advisory committee by a consultant are part of the administrative record
itemized in § 14.70.
[44 FR 22351, Apr. 13, 1979, as amended at 55 FR 42703, Oct. 23, 1990]
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Sec. 14.33 Compilation of materials for members of an advisory committee.
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The Commissioner shall prepare and provide to all committee members a
compilation of materials bearing upon members` duties and responsibilities,
including—
(a) All applicable conflict of interest laws and regulations and a summary of
their principal provisions;
(b) All applicable laws and regulations relating to trade secrets and
confidential commercial or financial information that may not be disclosed
publicly and a summary of their principal provisions;
(c) All applicable laws, regulations, and guidance documents relating to the
subject matter covered by the advisory committee and a summary of their
principal provisions;
(d) All applicable laws, regulations, including the regulations in part 20 of
this chapter, advisory committee charters, Federal Register
notices, curricula vitae, rules adopted by the advisory committee, and other
material relating to the formation, composition, and operation of the advisory
committee, and a summary of their principal provisions;
(e) Instructions on whom to contact when questions arise; and
(f) Other material relating to FDA and the subject matter covered by the
committee which may facilitate the work of the committee.
[44 FR 22351, Apr. 13, 1979, as amended at 65 FR 56479, Sept. 19, 2000]
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Sec. 14.35 Written submissions to an advisory committee.
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(a) Ten copies of written submissions to a committee are to be sent to the
executive secretary unless an applicable Federal Register notice
or other regulations in this chapter specify otherwise. Submissions are subject
to the provisions of § 10.20, except that it is not necessary to send
copies to the Division of Dockets Management.
(b) At the request of a committee, or on the Commissioner`s own initiative,
the Commissioner may issue in the Federal Register a notice
requesting the submission to the committee of written information and views
pertinent to a matter being reviewed by the committee. The notice may specify
the manner in which the submission should be made.
(c) At the request of a committee, or on the Commissioner`s own initiative,
the Commissioner may at any time request the applicant or sponsor of an
application or petition about a specific product on which action is pending
before FDA, and is being reviewed by an advisory committee, to present or
discuss safety, effectiveness, or other data concerning the product during a
regularly scheduled meeting of the committee. The request may be for an oral
presentation or for a concise, well-organized written summary of pertinent
information for review by the committee members before the meeting, or both.
Unless specified otherwise, one copy of the written summary along with a
proposed agenda outlining the topics to be covered and identifying the
participating industry staff members or consultants that will present each topic
is to be submitted to the executive secretary or other designated agency
employee at least 3 weeks before the meeting.
(d) An interested person may submit to a committee written information or
views on any matter being reviewed. Voluminous data is to be accompanied by a
summary. A submission is to be made to the executive secretary and not directly
to a committee member.
(1) FDA will distribute submissions to each member, either by mail or at the
next meeting. Submissions will be considered by the committee in its review of
the matter.
(2) A committee may establish, and give public notice of, a cutoff date after
which submissions about a matter will no longer be received or considered.
(e) The Commissioner will provide the committee all information the
Commissioner deems relevant. A member will, upon request, also be provided any
material available to FDA which the member believes appropriate for an
independent judgment on the matter, e.g., raw data underlying a summary or
report, or a briefing on the legal aspects of the matter.
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Sec. 14.39 Additional rules for a particular advisory committee.
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(a) In addition to these rules, an advisory committee may, with the
concurrence of the designated Federal employee, adopt additional rules which are
not inconsistent with this subpart or with other legal requirements.
(b) Any additional rules will be included in the minutes of the meeting when
adopted and in the materials compiled under § 14.33 and will be
available for public disclosure under § 14.65(c).
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Subpart C -- Establishment of Advisory Committees
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Sec. 14.40 Establishment and renewal of advisory committees.
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(a) An advisory committee may be established or renewed whenever it is
necessary or appropriate for the committee to hold a public hearing and to
review and make recommendations on any matter pending before FDA. Except for
committees established by statute, before a committee is established or renewed
it must first be approved by the Department pursuant to 45 CFR part 11 and by
the General Services Administration.
(b) When an advisory committee is established or renewed, the Commissioner
will issue a Federal Register notice certifying that the
establishment or renewal is in the public interest and stating the structure,
function, and purposes of the committee and, if it is a standing advisory
committee, shall amend § 14.100 to add it to the list of standing
advisory committees. A notice of establishment will be published at least 15
days before the filing of the advisory committee charter under paragraph (c) of
this section. A notice of renewal does not require the 15-day notice.
(c) No committee may meet or take action until its charter is prepared and
filed as required by section 9(c) of the Federal Advisory Committee Act. This
requirement is to be met by an advisory committee utilized by FDA, even though
it is not established by the agency, prior to utilization.
(d) The regulations of the Department cited in paragraph (a) of this section
provide that the charter of a parent committee may incorporate information
concerning activities of a subgroup. In such instances, a subgroup will not be
established as a committee distinct from the parent committee. However, a
subgroup will be established as a separate committee when the charter of the
parent committee does not incorporate the activities of the subgroup, or when
the subgroup includes members who are not all drawn from the parent committee.
(e) An advisory committee not required to be established by law will be
established or utilized only if it is in the public interest and only if its
functions cannot reasonably be performed by other existing advisory committees
or by FDA.
(f) An advisory committee must meet the following standards:
(1) Its purpose is clearly defined.
(2) Its membership is balanced fairly in terms of the points of view
represented in light of the functions to be performed. Although proportional
representation is not required, advisory committee members are selected without
regard to race, color, national origin, religion, age, or sex.
(3) It is constituted and utilizes procedures designed to assure that its
advice and recommendations are the result of the advisory committee`s
independent judgment.
(4) Its staff is adequate. The Commissioner designates an executive secretary
and alternate for every advisory committee, who are employees of FDA. The
executive secretary is responsible for all staff support unless other agency
employees are designated for this function.
(5) Whenever feasible, or required by statute, it includes representatives of
the public interest.
[44 FR 22351, Apr. 13, 1979, as amended at 55 FR 42703, Oct. 23, 1990]
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Sec. 14.55 Termination of advisory committees.
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(a) Except as provided in paragraph (c) of this section, a standing advisory
committee is terminated when it is no longer needed, or not later than 2 years
after its date of establishment unless it is renewed for an additional 2-year
period. A committee may be renewed for as many 2-year periods as the public
interest requires. The requirements for establishment of a committee under
§ 14.40 also apply to its renewal.
(b) FDA will issue a Federal Register notice announcing the
reasons for terminating a committee and, if it is a standing committee, amending
§ 14.100 to delete it from the list.
(c) TEPRSSC is a permanent statutory advisory committee established by
section 358(f)(1)(A) of the Public Health Service Act (42 U.S.C. 263f(f)(1)(A),
as added by the Radiation Control for Health and Safety Act of 1968, and is not
subject to termination and renewal under paragraph (a) of this section, except
that a new charter is prepared and filed at the end of each 2-year period as
provided in § 14.40(c). Also, the statutory medical device
classification panels established under section 513(b)(1) of the act and part
860, and the statutory medical device good manufacturing practice advisory
committees established under section 520(f)(3) of the act, are specifically
exempted from the normal 2-year duration period.
(d) The Board of Tea Experts is a permanent statutory advisory committee
established by the Tea Importation Act (21 U.S.C. 42) and is not subject to
termination and renewal under paragraph (a) of this section, except that a new
charter is prepared and filed at the end of each 2-year period as provided in
§ 14.40(c).
(e) Color additive advisory committees are required to be established under
the circumstances specified in section 721(b)(5) (C) and (D) of the act. A color
additive advisory committee is subject to the termination and renewal
requirements of the Federal Advisory Committee Act and of this part.
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Subpart D -- Records of Meetings and Hearings Before Advisory
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Sec. 14.60 Minutes and reports of advisory committee meetings.
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(a) The executive secretary or other designated agency employee prepares
detailed minutes of all advisory committee meetings, except that less detailed
minutes may be prepared for open portions of meetings which under
§ 14.61, must be transcribed or recorded by the agency. Their
accuracy is approved by the committee and certified by the chairman. The
approval and certification may be accomplished by mail or by telephone.
(b) The minutes include the following:
(1) The time and place of the meeting.
(2) The members, committee staff, and agency employees present, and the names
and affiliations or interests of public participants.
(3) A copy of or reference to all written information made available for
consideration by the committee at the proceedings.
(4) A complete and accurate description of matters discussed and conclusions
reached. A description is to be kept separately for the following portions of
the meeting to facilitate their public disclosure: The open portions specified
in § 14.25 (a) and (b), any closed portion during which a
presentation is made under § 14.25(c), and any closed deliberative
portion under § 14.25(d). The minutes of a closed deliberative
portion of a meeting may not refer to members by name, except upon their
request, or to data or information described in § 14.75(b). Any
inadvertent references that occur are to be deleted before public disclosure.
(5) A copy of or reference to all reports received, issued, or approved by
the committee.
(6) The extent to which the meeting was open to the public.
(7) The extent of public participation, including a list of members of the
public who presented oral or written statements.
(c) For a meeting that has a closed portion, either (1) the minutes of the
closed portion are available for public disclosure under
§ 14.75(a)(6)(i), or (2) if under § 14.75(a)(6)(ii) they
are not promptly available, the executive secretary or other designated agency
employee shall prepare a brief summary of the matters considered in an
informative manner to the public, consistent with 5 U.S.C. 552(b).
(d) Where a significant portion of the meeting of a committee is closed, the
committee will issue a report at least annually setting forth a summary of its
activities and related matters informative to the public consistent with 5
U.S.C. 552(b). This report is to be a compilation of or be prepared from the
individual reports on closed portions of meeting prepared under paragraph (c) of
this section.
[44 FR 22351, Apr. 13, 1979, as amended at 45 FR 85725, Dec. 30, 1980]
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Sec. 14.61 Transcripts of advisory committee meetings.
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(a) The agency will arrange for a transcript or recording to be made for each
portion of a meeting.
(b) A transcript or recording of an open portion of a meeting made by FDA is
to be included in the record of the committee proceedings.
(c) A transcript or recording of any closed portion of a meeting made by FDA
will not be included in the administrative record of the committee proceedings.
The transcript or recording will be retained as confidential by FDA, and will
not be discarded or erased.
(d) Any transcript or recording of a meeting or portion thereof which is
publicly available under this section will be available at actual cost of
duplication, which will be, where applicable, the fees established in
§ 20.45. FDA may furnish the requested transcript or recording for
copying to a private contractor who shall charge directly for the cost of
copying under § 20.53.
(e) A person attending any open portion of a meeting may, consistent with the
orderly conduct of the meeting, record or otherwise take a transcript of the
meeting. This transcription will not be part of the administrative record.
(f) Only FDA may make a transcript or recording of a closed portion of a
meeting.
[44 FR 22351, Apr. 13, 1979, as amended at 68 FR 25285, May 12, 2003]
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Sec. 14.65 Public inquiries and requests for advisory committee records.
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(a) Public inquiries on general committee matters, except requests for
records, are to be directed to: Committee Management Officer (HFA-306),
Office of Management and Operations, Food and Drug Administration, Department of
Health and Human Services, 5600 Fishers Lane, Rockville, MD 20857.
(b) Public inquiries on matters relating to a specific committee, except
requests for records, are to be directed to the executive secretary or the
designated agency employee listed in the Federal Register notices
published under § 14.20.
(c) Requests for public advisory committee records, including minutes, are to
be made, to FDA`s Freedom of Information Staff (HFI-35) under
§ 20.40 and the related provisions of part 20.
[44 FR 22351, Apr. 13, 1979, as amended at 46 FR 8456, Jan. 27, 1981]
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Sec. 14.70 Administrative record of a public hearing before an advisory committee.
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(a) Advice or recommendations of an advisory committee may be given only on
matters covered in the administrative record of the committee`s proceedings.
Except as specified in other FDA regulations, the administrative record consists
of all the following items relating to the matter:
(1) Any transcript or recording of an open portion of a meeting.
(2) The minutes of all portions of all meetings, after any deletions under
§ 14.60(b)(4).
(3) All written submissions to and information considered by the committee.
(4) All reports made by the committee.
(5) Any reports prepared by a consultant under § 14.31(e).
(b) The record of the proceeding is closed at the time the advisory committee
renders its advice or recommendations or at any earlier time specified by the
committee or in other sections in this chapter.
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Sec. 14.75 Examination of administrative record and other advisory committee
records.
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(a) The administrative record and other committee records are available for
public disclosure under part 20, except as provided in paragraph (b) of this
section, at the following times:
(1) The written information for consideration by the committee at any
meeting: at the same time it is made available to the committee.
(2) The transcript or recording of any open portion of a meeting: as soon as
it is available.
(3) The minutes of any open portion of a meeting: after they have been
approved by the committee and certified by the chairman.
(4) The brief summary of any closed portion of a meeting prepared under
§ 14.60(c): as soon as it is available.
(5) All written information or views submitted to the committee at an open
portion of a meeting: as soon as they are submitted.
(6) The minutes or portions thereof of a closed portion of a meeting—
(i) For a matter not directed to be maintained as confidential under
§ 14.22(i)(2): After they have been approved by the committee and
certified by the chairman; and
(ii) For a matter directed to be maintained as confidential under
§ 14.22(i)(2): After the advice or report of the committee relevant
to those minutes or portions thereof is acted upon by the Commissioner, or upon
a determination by the Commissioner that such minutes or portions thereof may be
made available for public disclosure without undue interference with agency or
advisory committee operations.
(7) Formal advice or a report of the committee: After it has been acted upon,
i.e., approved, disapproved, or rejected as inadequate, by the Commissioner, or
upon a determination by the Commissioner that such formal advice or report may
be made available for public disclosure without undue interference with agency
or committee operations. Such formal advice or report may be retained as
confidential while it is under active advisement.
(8) Any other committee records relating to the matter, except transcripts
and recordings of closed portions of meetings: After the advice or report of the
committee relevant to those records is acted upon by the Commissioner, or upon a
determination by the Commissioner that the records may be made available for
public disclosure without undue interference with agency or committee
operations.
(b) The following information contained in the administrative record is not
available for public examination or copying except as provided in
§ 12.32(g):
(1) Material provided to the committee by FDA that is exempt from public
disclosure under part 20 and the regulations referenced there.
(2) Material provided to the advisory committee by a person making a
presentation described in § 14.25(c) and which is prohibited from
public disclosure under part 20 and the regulations referenced there.
(c) The Division of Dockets Management (HFA-305) will maintain a file
for each committee containing the following principal records for ready access
by the public:
(1) The committee charter.
(2) A list of committee members and their curricula vitae.
(3) The minutes of committee meetings.
(4) Any formal advice or report of the committee.
[44 FR 22351, Apr. 13, 1979, as amended at 54 FR 9035, Mar. 3, 1989]
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Subpart E -- Members of Advisory Committees
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Sec. 14.80 Qualifications for members of standing policy and technical advisory
committees.
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(a) Members of a policy advisory committee—
(1) Shall have diverse interests, education, training, and experience;
specific technical expertise is not a requirement;
(2) Are subject to the conflict of interest laws and regulations either as
special Government employees or as members of the uniformed services, including
the Commissioned Corps of the Public Health Service (the Commissioner has
determined that, because members representing particular interests, e.g., a
representative of labor, industry, consumers, or agriculture, are included on
advisory committees specifically for the purpose of representing these
interests, any financial interest covered by 18 U.S.C. 208(a) in the class which
the member represents is irrelevant to the services which the Government expects
from them and thus is hereby exempted under 18 U.S.C. 208(b) as too remote and
inconsequential to affect the integrity of their services); and
(3) Shall be voting members.
(b) Technical advisory committee.(1) Voting members of
technical advisory committees—
(i) Shall have expertise in the subject matter with which the committee is
concerned and have diverse professional education, training, and experience so
that the committee will reflect a balanced composition of sufficient scientific
expertise to handle the problems that come before it; and
(ii) Except for members of the Technical Electronic Product Radiation Safety
Standards Committee (TEPRSSC), are subject to the conflict of interest laws and
regulations either as special Government employees or as members of the
uniformed services, including the Commissioned Corps of the Public Health
Service.
(2) The Commissioner shall, when required by statute, and may when not
required by statute, provide for nonvoting members of a technical advisory
committee to serve as representatives of and liaison with interested
organizations. Nonvoting members—
(i) Shall be selected by the interested organizations, as provided in
§ 14.84; technical expertise in the subject matter with which the
committee is involved is not a requirement; and
(ii) May be special Government employees subject to the conflict of interest
laws and regulations, except as provided in § 14.84(e).
(c) A person may serve as a voting or nonvoting member on only one FDA
advisory committee unless the Commissioner determines in writing that dual
membership will aid the work of the committees involved and is in the public
interest.
(d) Members of FDA advisory committees, and the chairman, are appointed from
among those nominated under §§ 14.82 and 14.84 and from any
other sources by the Secretary, or, by delegation of authority, by the Assistant
Secretary for Health, or the Commissioner.
(e) Members appointed to an advisory committee serve for the duration of the
committee, or until their terms of appointment expire, they resign, or they are
removed from membership by the Commissioner.
(f) A committee member may be removed from membership for good cause. Good
cause includes excessive absenteeism from committee meetings, a demonstrated
bias that interferes with the ability to render objective advice, failure to
abide by the procedures established in this subpart, or violation of other
applicable rules and regulations, e.g., for nonvoting members, the provisions of
§ 14.86(c).
(g) Consultants appointed under § 14.31(e) are not members of
advisory committees.
[44 FR 22351, Apr. 13, 1979, as amended at 53 FR 50949, Dec. 19, 1988; 54
FR 9035, Mar. 3, 1989]
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Sec. 14.82 Nominations of voting members of standing advisory committees.
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(a) The Commissioner will publish one or more notices in the Federal Register each year requesting nominations for voting members
of all existing standing advisory committees. The notice will invite the
submission of nominations for voting members from both individuals and
organizations.
(b) The notice announcing the establishment of a new committee under
§ 14.40(b) will invite the submission of nominations for voting
members.
(c) A person may nominate one or more qualified persons to an advisory
committee. Nominations will specify the advisory committee for which the nominee
is recommended and will include a complete curriculum vitae of the nominee.
Nominations are to state that the nominee is aware of the nomination, is willing
to serve as a member of the advisory committee, and appears to have no conflict
of interest that would preclude membership.
(d) Voting members serve as individuals and not as representatives of any
group or organization which nominated them or with which they may be affiliated.
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Sec. 14.84 Nominations and selection of nonvoting members of standing technical
advisory committees.
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(a) This section applies when the Commissioner concludes that a technical
advisory committee should include nonvoting members to represent and serve as a
liaison with interested individuals and organizations.
(b) Except when the Commissioner concludes otherwise, nonvoting members of a
technical advisory committee are selected in accordance with paragraphs (c) and
(d) of this section and are normally limited to one person selected by consumer
groups and organizations and one person selected by industry groups and
organizations.
(c) To select a nonvoting member to represent consumer interests, except as
provided in paragraph (c)(5) of this section, the Commissioner publishes a
notice in the Federal Register requesting nominations for each
specific committee, or subcommittee, for which nonvoting members are to be
appointed.
(1) A period of 30 days will be permitted for submission of nominations for
that committee or subcommittee. Interested persons may nominate one or more
qualified persons to represent consumer interests. Although nominations from
individuals will be accepted, individuals are encouraged to submit their
nominations through consumer organizations as defined in paragraph (c)(3) of
this section. Nominations of qualified persons for general consideration as
nonvoting members of unspecified advisory committees or subcommittees may be
made at any time. All nominations are to be submitted in writing to the Office
of Consumer Affairs (HFE-40), Food and Drug Administration, Rm.
16-85, 5600 Fishers Lane, Rockville, MD 20857.
(2) A complete curriculum vitae of any nominee is to be included. Nominations
must state that the nominee is aware of the nomination, is willing to serve as a
member of an advisory committee, and appears to have no conflict of interest.
The nomination must state whether a nominee is interested only in a particular
advisory committee or subcommittee, or whether the nominee is interested in
becoming a member of any advisory committee or subcommittee. Nominations that do
not comply with the requirements of this paragraph will not be considered.
(3) The Office of Consumer Affairs will compile a list of organizations whose
objectives are to promote, encourage, and contribute to the advancement of
consumer education and to the resolution of consumer problems. All organizations
listed are entitled to vote upon the nominees. The list will include
organizations representing the public interest, consumer advocacy groups, and
consumer/health branches of Federal, State, and local governments. Any
organization that meets the criteria may be included on such list on request.
(4) The executive secretary, or other designated agency employee, will review
the list of nominees and select three to five qualified nominees to be placed on
a ballot. Names not selected will remain on a list of eligible nominees and be
reviewed periodically by the Office of Consumer Affairs to determine continued
interest. Upon selection of the nominees to be placed on the ballot, the
curriculum vitae for each of the nominees will be sent to each of the
organizations on the list complied under paragraph (c)(3) of this section,
together with a ballot to be filled out and returned within 30 days. After the
time for return of the ballots has expired, the ballots will be counted and the
nominee who has received the highest number of votes will be selected as the
nonvoting member representing consumer interests for that particular advisory
committee or subcommittee. In the event of a tie, the Commissioner will select
the winner by lot from among those tied for the highest number of votes.
(5) If a member representing consumer interests resigns or is removed before
termination of the committee on which the member is serving, the following
procedures will be used to appoint a replacement to serve out the term of the
former member:
(i) The Commissioner will appoint the runner-up, in order of number of
ballots received, on the original ballot submitted under paragraph (c)(4) of
this section to fill the vacancy. If the runner-up is no longer willing to serve
as a member, then the next runner-up will be appointed.
(ii) If none of the nominees on the original ballot is willing to serve, or
if there was only one nominee on the original ballot, the Office of Consumer
Affairs will contact by telephone eligible individuals whose names have been
submitted in the past as candidates for membership as representatives of
consumer interests. A list of persons who are interested in serving on an
advisory committee will then be prepared. The curricula vitae of these persons,
together with a ballot, will be sent to a representative number of consumer
organizations that have been determined to be eligible to vote for consumer
representatives in accordance with paragraph (c)(3) of this section. After 4
days have elapsed, the Office of Consumer Affairs will contact the consumer
organizations by telephone and elicit their votes. The candidate who has
received the highest number of votes will be selected. In the event of a tie,
the Commissioner will select the winner by lot from among those tied for the
highest number of votes.
(d) To select a nonvoting member to represent industry interests, the
Commissioner will publish, for each committee for which the Commissioner has
determined to appoint a nonvoting member, a notice requesting that, within 30
days, any industry organization interested in participating in the selection of
an appropriate nonvoting member to represent industry interests send a letter
stating that interest to the FDA employee designated in the notice. After 30
days, a letter will be sent to each organization that has expressed an interest,
attaching a complete list of all such organizations, and stating that it is
their responsibility to consult with each other in selecting, within 60 days
after receipt of the letter, a single nonvoting member to represent industry
interests for that committee. If no individual is selected within 60 days, the
Commissioner will select the nonvoting member representing industry interests.
(e) The Commissioner has determined that, because nonvoting members
representing consumer and industry interests are included on advisory committees
specifically for the purpose of representing such interests and have no vote,
any financial interest covered by 18 U.S.C. 208(a) in the class which the member
represents is irrelevant to the services the Government expects from them and
thus is hereby exempted under 18 U.S.C. 208(b) as too remote and inconsequential
to affect the integrity of their services.
[44 FR 22351, Apr. 13, 1979, as amended at 54 FR 9035, Mar. 3, 1989]
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Sec. 14.86 Rights and responsibilities of nonvoting members of advisory
committees.
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(a) A nonvoting member of an advisory committee selected to represent and
serve as a liaison with interested individuals, associations, and organizations
has the same rights as any other committee member except that—
(1) A nonvoting member may vote only on procedural matters such as additional
rules adopted under § 14.39(a), approval of minutes under
§ 14.60(a), decisions on transcripts under § 14.61(b), and
future meeting dates;
(2) A nonvoting member who is a representative of industry interest may have
access to data and information that constitute a trade secret or confidential
commercial or financial information as defined in § 20.61 only if the
person has been appointed as a special Government employee under
§ 14.80(b).
(b) A nonvoting member of an advisory committee is subject to, and shall
abide by, all rules and regulations adopted by FDA and the committee.
(c) It is the responsibility of the nonvoting consumer and industry members
of an advisory committee to represent the consumer and industry interests in all
deliberations.
(1) A nonvoting member does not represent any particular organization or
group, but rather represents all interested persons within the class which the
member is selected to represent. Accordingly, an interested person within the
class represented by that nonvoting member may, upon request, have access to all
written statements or oral briefings concerning the committee prepared by the
nonvoting member for distribution to any person outside the committee. When
documents are prepared with non-Government funds, persons desiring copies may be
required to pay a reasonable fee to cover printing and similar costs.
(2) The nonvoting member reviews all official committee minutes to assure
their completeness and accuracy.
(3) The nonvoting member acts as a liaison between the committee and the
interested persons whom that member represents, and transmits requests for
information from the committee and relevant information and views to the
committee. The nonvoting member takes the initiative in contacting interested
persons whom the member represents to seek out relevant information and views
and to relate the progress of the advisory committee.
(4) A nonvoting industry member represents all members of the industry, and
not any particular association, company, product, or ingredient. If a matter
comes before the committee that directly or indirectly affects the company
employing the nonvoting industry member, the member shall so inform the
committee but need not be absent during the discussion or decline to participate
in the discussion. a nonvoting industry member may not discuss the company`s
position as such, but may discuss any matter in general terms. All presentations
and discussions of scientific data and their interpretation on behalf of a
company will occur in open session, except as provided in § 14.25(c).
(5) A nonvoting member of an advisory committee may not make any presentation
to that advisory committee during a hearing conducted by that committee.
(6) Although a nonvoting member serves in a representative capacity, the
nonvoting member shall exercise restraint in performing such functions and may
not engage in unseemly advocacy or attempt to exert undue influence over the
other members of the committee.
(d) A nonvoting member of an advisory committee may be removed by the
Commissioner for failure to comply with this section as well as
§ 14.80(f).
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Sec. 14.90 Ad hoc advisory committee members.
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In selecting members of an ad hoc advisory committee, the Commissioner may
use the procedures in §§ 14.82 and 14.84 or any other procedure
deemed appropriate.
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Sec. 14.95 Compensation of advisory committee members.
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(a)(1) Except as provided in paragraphs (a) (2) and (3) of this section, all
voting advisory committee members shall, and nonvoting members may, be appointed
as special Government employees and receive a consultant fee and be reimbursed
for travel expenses, including per diem in lieu of subsistence, unless such
compensation and reimbursement are waived.
(2) Members of the Technical Electronic Product Radiation Safety Standards
Committee (TEPRSSC) are not appointed as special Government employees. Any
member of TEPRSSC who is not a Federal employee or member of the uniformed
services, including the Commissioned Corps of the Public Health Service, shall
receive a consultant fee and be reimbursed for travel expenses, including per
diem in lieu of subsistence, unless such compensation and reimbursement are
waived.
(3) Voting and nonvoting advisory committee members who are members of the
uniformed services, including the Commissioned Corps of the Public Health
Service, provide service on Food and Drug Administration advisory committees as
part of their assigned functions, are not appointed as special government
employees, but are reimbursed by the Food and Drug Administration for travel
expenses.
(b) Notwithstanding the member`s primary residence, an advisory committee
member, while attending meetings of the full committee or a subcommittee, will
be paid whether the meetings are held in the Washington, DC, area or elsewhere.
(c) A committee member who participates in any agency-directed assignment
will be paid at an hourly rate when doing assigned work at home, a place of
business, or in an FDA facility located within the member`s commuting area, and
at a daily rate when required to travel outside of that commuting area to
perform the assignment. A committee member will not be paid for time spent on
normal preparation for a committee meeting.
(1) An agency-directed assignment is an assignment that meets the following
criteria:
(i) An activity that requires undertaking a definitive study. The activity
must produce a tangible end product, usually a written report. Examples are:
(a) An analysis of the risks and benefits of the use of a class
of drugs or a report on a specific problem generated by an IND or NDA;
(b) The performance of similar investigations or analysis of
complex industry submissions to support advisory committee deliberations other
than normal meeting preparation;
(c) The preparation of a statistical analysis leading to an
estimate of toxicologically safe dose levels; and
(d) The design or analysis of animal studies of toxicity,
mutagenicity, teratogenicity, or carcinogenicity.
(ii) The performance of an IND or NDA review or similar review.
(2) A committee member who undertakes a special assignment, the end product
of which does not represent the end product of the advisory committee, but
rather of the committee member`s own assignment, can be compensated. Should this
preparatory work by members collectively result in an end product of the
committee, this is to be considered normal meeting preparation and committee
members are not to be compensated for this work.
(d) Salary while in travel status is authorized when a committee member`s
ordinary pursuits are interrupted for the substantial portion of an additional
day beyond the day or days spent in performing those services, and as a
consequence the committee member loses some regular compensation. This applies
on weekends and holidays if the special Government employee loses income that
would otherwise be earned on that day. For travel purposes, a substantial
portion of a day is defined as 50 percent of the working day, and the traveler
will be paid at a daily rate.
[44 FR 22351, Apr. 13, 1979, as amended at 53 FR 50949, Dec. 19, 1988]
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Subpart F -- Standing Advisory Committees
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Sec. 14.100 List of standing advisory committees.
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Standing advisory committees and the dates of their establishment are as
follows:
(a) Office of the Commissioner—(1) Board of Tea
Experts.
(i) Date established: March 2, 1897.
(ii) Function: Advises on establishment of uniform standards of purity,
quality, and fitness for consumption of all tea imported into the United States
under 21 U.S.C. 42.
(2) Science Board to the Food and Drug Administration.
(i) Date established: June 26, 1992.
(ii) Function: The board shall provide advice primarily to the agency`s
Senior Science Advisor and, as needed, to the Commissioner and other appropriate
officials on specific complex and technical issues as well as emerging issues
within the scientific community in industry and academia. Additionally, the
board will provide advice to the agency on keeping pace with technical and
scientific evolutions in the fields of regulatory science; on formulating an
appropriate research agenda; and on upgrading its scientific and research
facilities to keep pace with these changes. It will also provide the means for
critical review of agency sponsored intramural and extramural scientific
research programs.
(b) Center for Biologics Evaluation and Research—(1) Allergenic Products Advisory Committee.
(i) Date established: July 9, 1984.
(ii) Function: Reviews and evaluates data on the safety and effectiveness of
allergenic biological products intended for use in the diagnosis, prevention, or
treatment of human disease.
(2) Biological Response Modifiers Advisory Committee.
(i) Date established: October 28, 1988.
(ii) Function: Reviews and evaluates data relating to the safety,
effectiveness, and appropriate use of biological response modifiers which are
intended for use in the prevention and treatment of a broad spectrum of human
diseases.
(3) Blood Products Advisory Committee.
(i) Date established: May 13, 1980.
(ii) Function: Reviews and evaluates data on the safety and effectiveness,
and appropriate use of blood products intended for use in the diagnosis,
prevention, or treatment of human diseases.
(4) [Reserved]
(5) Vaccines and Related Biological Products Advisory
Committee.
(i) Date established: December 31, 1979.
(ii) Function: Reviews and evaluates data on the safety and effectiveness of
vaccines intended for use in the diagnosis, prevention, or treatment of human
diseases.
(6) Transmissible Spongiform Encephalopathies Advisory
Committee.
(i) Date established: June 21, 1995.
(ii) Function: Reviews and evaluates available scientific data concerning the
safety of products which may be at risk for transmission of spngiform
encephalopathies having an impact on the public health.
(c) Center for Drug Evaluation and Research—(1) Anesthetic and Life Support Drugs Advisory Committee.
(i) Date established: May 1, 1978.
(ii) Function: Reviews and evaluates data on the safety and effectiveness of
marketed and investigational human drugs for use in the field of anesthesiology
and surgery.
(2) Anti-Infective Drugs Advisory Committee.
(i) Date established: October 7, 1980.
(ii) Function: Reviews and evaluates available data concerning the safety and
effectiveness of marketed and investigational human drug products for use in the
treatment of infectious diseases and disorders.
(3) Antiviral Drugs Advisory Committee.
(i) Date established: February 15, 1989.
(ii) Function: Reviews and evaluates available data concerning the safety and
effectiveness of marketed and investigational human drug products for use in the
treatment of acquired immune deficiency syndrome (AIDS), AIDS-related complex
(ARC), and other viral, fungal, and mycobacterial infections.
(4) Arthritis Advisory Committee.
(i) Date established: April 5, 1974.
(ii) Function: Reviews and evaluates data on the safety and effectiveness of
marketed and investigational human drugs for use in arthritic conditions.
(5) Cardiovascular and Renal Drugs Advisory Committee.
(i) Date established: August 27, 1970.
(ii) Function: Reviews and evaluates data on the safety and effectiveness of
marketed and investigational human drugs for use in cardiovascular and renal
disorders.
(6) Dermatologic and Ophthalmic Drugs Advisory Committee.
(i) Date established: October 7, 1980.
(ii) Function: Reviews and evaluates available data concerning the safety and
effectiveness of marketed and investigational human drug products for use in the
treatment of dermatologic and ophthalmic disorders.
(7) Drug Safety and Risk Management Advisory Committee.
(i) Date established: May 31, 1978.
(ii) Function: Reviews and evaluates data on risk management plans, provides
active surveillance methodologies, trademark studies, methodologies for risk
management communication, and related issues.
(8) Endocrinologic and Metabolic Drugs Advisory Committee.
(i) Date established: August 27, 1970.
(ii) Function: Reviews and evaluates data on the safety and effectiveness of
marketed and investigational human drugs for use in endocrine and metabolic
disorders.
(9) Advisory Committee for Reproductive Health Drugs.
(i) Date established: March 23, 1978.
(ii) Function: Reviews and evaluates data on the safety and effectiveness of
marketed and investigational human drugs for use in the practice of obstetrics,
gynecology, and related specialties.
(10) Gastrointestinal Drugs Advisory Committee.
(i) Date established: March 3, 1978.
(ii) Function: Reviews and evaluates data on the safety and effectiveness of
marketed and investigational human drugs for use in gastrointestinal diseases.
(11) Oncologic Drugs Advisory Committee.
(i) Date established: September 1, 1978.
(ii) Function: Reviews and evaluates data on the safety and effectiveness of
marketed and investigational human drugs for use in treatment of cancer.
(12) Peripheral and Central Nervous System Drugs Advisory
Committee.
(i) Date established: June 4, 1974.
(ii) Function: Reviews and evaluates data on the safety and effectiveness of
marketed and investigational human drugs for use in neurological disease.
(13) Psychopharmacologic Drugs Advisory Committee.
(i) Date established: June 4, 1974.
(ii) Function: Reviews and evaluates data on the safety and effectiveness of
marketed and investigational human drugs for use in the practice of psychiatry
and related fields.
(14) Pulmonary-Allergy Drugs Advisory Committee.
(i) Date established: February 17, 1972.
(ii) Function: Reviews and evaluates data on the safety and effectiveness of
marketed and investigational human drugs for use in the treatment of pulmonary
disease and diseases with allergic and/or immunologic mechanisms.
(15) Medical Imaging Drugs Advisory Committee.
(i) Date established: August 30, 1967.
(ii) Function: Reviews and evaluates data concerning the safety and
effectiveness of marketed and investigational human drug products for use in
diagnostic and therapeutic procedures using radioactive pharmaceuticals and
contrast media used in diagnostic radiology.
(16) Advisory Committe for Pharmaceutical Science.
(i) Date established: January 22, 1990.
(ii) Function: Gives advice on scientific and technical issues concerning the
safety and effectiveness of human generic drug products for use in the treatment
of a broad spectrum of human diseases.
(17) Nonprescription Drugs Advisory Committee.
(i) Date established: August 27, 1991.
(ii) Functions: The committee reviews and evaluates available data concerning
the safety and effectiveness of over-the-counter (nonprescription) human drug
products for use in the treatment of a broad spectrum of human symptoms and
diseases.
(18) Pharmacy Compounding Advisory Committee.
(i) Date established: February 12, 1998.
(ii) Function: Provides advice on scientific, technical, and medical issues
concerning drug compounding by pharmacists and licensed practitioners.
(d) Center for Devices and Radiological Health—(1) Medical Devices Advisory Committee.
(i) Date established: October 27, 1990.
(ii) Function: Reviews and evaluates data on the safety and
effectiveness of marketed and investigational devices and makes recommendations
for their regulation.
(2) Device Good Manufacturing Practice Advisory Committee.
(i) Date established: May 17, 1987.
(ii) Function: Reviews proposed regulations for good manufacturing practices
governing the methods used in, and the facilities and controls used for, the
manufacture, packing, storage, and installation of devices, and makes
recommendations on the feasibility and reasonableness of the proposed
regulations.
(3) Technical Electronic Product Radiation Safety Standards
Committee.
(i) Date established: October 18, 1968.
(ii) Function: Advises on technical feasibility, reasonableness, and
practicability of performance standards for electronic products to control the
emission of radiation under 42 U.S.C. 263f(f)(1)(A).
(4) National Mammography Quality Assurance Advisory Committee.
(i) Date established: July 6, 1993.
(ii) Function: Advises on developing appropriate quality standards and
regulations for the use of mammography facilities.
(e) National Center for Toxicological Research—Science Advisory Board.
(1) Date established: June 2, 1973.
(2) Function: Advises on establishment and implementation of a research
program that will assist the Commissioner of Food and Drugs tofulfill regulatory
responsibilities.
(f) Center for Veterinary Medicine—Veterinary
Medicine Advisory Committee.
(1) Date established: April 24, 1984.
(2) Function: Reviews and evaluates available data concerning safety and
effectiveness of marketed and investigational new animal drugs, feeds, and
devices for use in the treatment and prevention of animal disease and increased
animal production.
(g) Center for Food Safety and Applied Nutrition—Food
Advisory Committee.
(1) Date established: December 15, 1991.
(2) Function: The committee provides advice on emerging food safety, food
science, and nutrition issues that FDA considers of primary importance in the
next decade.
[54 FR 9036, Mar. 3, 1989]
Editorial Note:For Federal Register citations
affecting § 14.100, see the List of CFR Sections Affected, which
appears in the Finding Aids section of the printed volume and on GPO
Access.
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Subpart G -- Technical Electronic Products Radiation Safety
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Sec. 14.120 Establishment of the Technical Electronic Product Radiation Safety
Standards Committee (TEPRSSC).
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The Technical Electronic Product Radiation Safety Standards Committee
(TEPRSSC), consisting of 15 members, is established in accordance with the
Radiation Control for Health and Safety Act of 1968 (42 U.S.C. 263f(f)(1)(A)) to
provide consultation before the Commissioner prescribes any performance standard
for an electronic product.
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Sec. 14.122 Functions of TEPRSSC.
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(a) In performing its function of advising the Commissioner, TEPRSSC—
(1) May propose electronic product radiation safety standards to the
Commissioner for consideration;
(2) Provides consultation to the Commissioner on all performance standards
proposed for consideration under 42 U.S.C. 263f; and
(3) May make recommendations to the Commissioner on any other matters it
deems necessary or appropriate in fulfilling the purposes of the act.
(b) Responsibility for action on performance standards under 42 U.S.C. 263f
rests with the Commissioner, after receiving the advice of TEPRSSC.
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Sec. 14.125 Procedures of TEPRSSC.
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(a) When the Commissioner is considering promulgation of a performance
standard for an electronic product, or an amendment of an existing standard,
before issuing a proposed regulation in the Federal Register the
Commissioner will submit to TEPRSSC the proposed standard or amendment under
consideration, together with other relevant information to aid TEPRSSC in its
deliberations.
(b) The agenda and other material to be considered at any meeting will be
sent to members whenever possible at least 2 weeks before the meeting.
(c) Ten members constitute a quorum, provided at least three members are
present from each group specified in 42 U.S.C. 263f(f)(1)(A) and in
§ 14.127(a), i.e., Government, industry, and the public.
(d) The chairman of TEPRSSC will ordinarily submit a report to the
Commissioner of the committee`s consideration of any proposed performance
standard for an electronic product within 60 days after consideration. If the
chairman believes that more time is needed, the chairman will inform the
Director of the Center for Devices and Radiological Health in writing, in which
case an additional 30 days will be allowed to make the report.
(e) Sections 14.1 through 14.7 apply to TEPRSSC, except where other
provisions are specifically included in §§ 14.120 through
14.130.
[44 FR 22351, Apr. 13, 1979, as amended at 54 FR 9037, Mar. 3, 1989]
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Sec. 14.127 Membership of TEPRSSC.
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(a) The Commissioner will appoint the members after consultation with public
and private organizations concerned with the technical aspect of electronic
product radiation safety. TEPRSSC consists of 15 members, each of whom is
technically qualified by training and experienced in one or more fields of
science or engineering applicable to electronic product radiation safety, as
follows:
(1) Five members selected from government agencies, including State and
Federal Governments.
(2) Five members selected from the affected industries after consultation
with industry representatives.
(3) Five members selected from the general public, of whom at least one shall
be a representative of organized labor.
(b) The Commissioner will appoint a committee member as chairman of TEPRSSC.
(c) Appointments of members are for a term of 3 years or as specified by the
Commissioner.
(1) The chairman is appointed for a term concurrent with the chairman`s term
as a member of TEPRSSC. If the chairmanship becomes vacant without adequate
notice, the executive secretary may appoint a committee member as temporary
chairman pending appointment of a new chairman by the Commissioner.
(2) Members may not be reappointed for a second consecutive full term.
(d) A person otherwise qualified for membership is not eligible for selection
as a member of TEPRSSC from Government agencies or the general public if the
Commissioner determines that the person does not meet the requirements of the
conflict of interest laws and regulations.
(e) Retention of membership is conditioned upon the following:
(1) Continued status as a member of the group from which the member was
selected as specified in paragraph (a) of this section.
(2) Absence of any conflict of interest during the term of membership as
specified in paragraph (d) of this section.
(3) Active participation in TEPRSSC activities.
(f) Appointment as a member of TEPRSSC is conditioned on certification that
the prospective member:
(1) Agrees to the procedures and criteria specified in this subpart.
(2) Has no conflict of interest as specified in paragraph (d) of this
section.
(3) Will notify the executive secretary of TEPRSSC before any change in
representative status on TEPRSSC which may be contrary to the conditions of the
appointment.
(g) Members of TEPRSSC who are not full-time officers or employees of the
United States receive compensation under § 14.95, in accordance with
42 U.S.C. 210(c).
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Sec. 14.130 Conduct of TEPRSSC meeting; availability of TEPRSSC records.
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(a) In accordance with 42 U.S.C. 263f(f)(1)(B), all proceedings of TEPRSSC
are recorded, and the record of each proceeding is available for public
inspection.
(b) All proceedings of TEPRSSC are open except when the Commissioner has
determined, under § 14.27, that a portion of a meeting may be closed.
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Subpart H -- Color Additive Advisory Committees
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Sec. 14.140 Establishment of a color additive advisory committee.
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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 § 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 § 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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Sec. 14.142 Functions of a color additive advisory committee.
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(a) A color additive advisory committee reviews all available information
relating to the matter referred to it, including all information contained in
any pertinent color additive petition and in FDA files. All information reviewed
is placed on public display and is available for review at the office of the
Division of Dockets Management.
(b) The Commissioner specifies to the color additive advisory committee, in
writing, the issues on which review and recommendations are requested.
(c) The date of the first meeting of a color additive advisory committee,
following receipt of the administrative record by each of the committee members,
is designated as the beginning of the period allowed for consideration of the
matter by the committee. Within 60 days after the first meeting, unless the time
is extended as provided in paragraph (d) of this section, the chairman of the
committee shall certify to the Commissioner the report containing the
recommendations of the committee, including any minority report. The report
states the recommendations of the committee and the reasons or basis for them.
The report includes copies of all material considered by the committee in
addition to the administrative record furnished to it.
(d) If the chairman concludes that the color additive advisory committee
needs additional time, the chairman shall so inform the Commissioner in writing
and may certify the report of the committee to the Commissioner within 90 days
instead of 60 days.
(e) More than one matter may be handled concurrently by a color additive
advisory committee.
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Sec. 14.145 Procedures of a color additive advisory committee.
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(a) A color additive advisory committee is subject to all the requirements of
the Federal Advisory Committee Act and this part.
(b) All interested persons have a right to consult with the color additive
advisory committee reviewing a matter and to submit information and views to a
color additive advisory committee, in accordance with the procedures in this
part.
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Sec. 14.147 Membership of a color additive advisory committee.
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(a) The members of a color additive advisory committee are selected in the
following manner:
(1) If a color additive advisory committee is established for purposes that
do not include review of an issue arising under section 721(b)(5)(B) of the act,
or is established on the initiative of the Commissioner, the Commissioner may
use the procedure in paragraph (a)(2) of this section to select the members or
may use an existing standing advisory committee listed in § 14.100,
or may establish a new advisory committee under this subpart. Once the
Commissioner has established a color additive advisory committee under this
paragraph and has referred to it a matter relating to a color additive, no
interested person may subsequently request that an additional or different color
additive advisory committee be established to review and make recommendations
about that color additive.
(2) If the Commissioner established a color additive advisory committee to
review an issue arising under section 721(b)(5)(B) of the act on the request of
an interested person, it shall be established under the following requirements:
(i) Except as provided in paragraph (a)(2) (ii) and (iii) of this section,
the Commissioner will request the National Academy of Sciences to select the
members of a color additive advisory committee from among experts qualified in
the subject matter to be reviewed by the committee, and of adequately
diversified professional backgrounds. The Commissioner will appoint one of the
members as the chairman.
(ii) If the National Academy of Sciences is unable or refuses to select the
members of a color additive advisory committee, the Commissioner will select the
members.
(iii) If the Commissioner and the requesting party agree, section
721(b)(5)(D) of the act may be waived and the matter may be referred to any
standing advisory committee listed in § 14.100 or to any advisory
committee established under any other procedure that is mutually agreeable. Once
the Commissioner has established a color additive advisory committee and has
referred to it a matter relating to a color additive, no interested person may
subsequently request that an additional or different color additive advisory
committee be established to review and make recommendations about that color
additive.
(b) Members of a color additive advisory committee are subject to the
requirements of the Federal Advisory Committee Act and this subpart, except that
no member of a color additive advisory committee may by reason of such
membership alone be a special government employee or be subject to the conflict
of interest laws and regulations.
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Sec. 14.155 Fees and compensation pertaining to a color additive advisory
committee.
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(a) When a matter is referred to a color additive advisory committee, all
related costs, including personal compensation of committee members, travel,
materials, and other costs, are borne by the person requesting the referral,
such costs to be assessed on the basis of actual cost to the government. The
compensation of such costs includes personal compensation of committee members
at a rate not to exceed $128.80 per member per day.
(b) In the case of a request for referral to a color additive advisory
committee, a special advance deposit is to be made in the amount of $2,500.
Where required, further advances in increments of $2,500 each are to be made
upon request of the Commissioner. All deposits for referrals to a color additive
advisory committee in excess of actual expenses will be refunded to the
depositor.
(c) All deposits and fees required by this section are to be paid by money
order, bank draft, or certified check drawn to the order of the Food and Drug
Administration, collectable at par in Washington, DC. All deposits and fees are
to be forwarded to the Associate Commissioner for Management and Operations,
Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, and after
appropriate record of them is made, they will be transmitted to the Treasurer of
the United States for deposit in the special account “Salaries and
Expenses, Certification, Inspection, and Other Services, Food and Drug
Administration.”
(d) The Commissioner may waive or refund such fees in whole or in part when,
in the Commissioner`s judgment, such action will promote the public interest.
Any person who believes that payment of these fees will be a hardship may
petition the Commissioner under § 10.30 to waive or refund the fees.
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Subpart I -- Advisory Committees for Human Prescription Drugs
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Sec. 14.160 Establishment of standing technical advisory committees for human
prescription drugs.
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The standing technical advisory committees for human prescription drugs are
established to advise the Commissioner:
(a) Generally on the safety and effectiveness, including the labeling and
advertising, and regulatory control of the human prescription drugs falling
within the pharmacologic class covered by the advisory committee and on the
scientific standards appropriate for a determination of safety and effectiveness
in that class of drugs.
(b) Specifically on any particular matter involving a human prescription drug
pending before FDA, including whether the available information is adequate to
support a determination that—
(1) A particular IND study may properly be conducted;
(2) A particular drug meets the statutory standard for proof of safety and
effectiveness necessary for approval or continued approval for marketing; or
(3) A particular drug is properly classified as a new drug, an old drug, or a
banned drug.
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Sec. 14.171 Utilization of an advisory committee on the initiative of FDA.
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(a) Any matter involving a human prescription drug under review within the
agency may, in the discretion of the Commissioner, be the subject of a public
hearing and continuing or periodic review by the appropriate standing technical
advisory committee for human prescription drugs. The Commissioner`s
determinations on the agenda of the committee are based upon the priorities of
the various matters pending before the agency which fall within the
pharmacologic class covered by that committee.
(b) High priority for such hearing and review by the appropriate standing
technical advisory committee for human prescription drugs are given to the
following types of human prescription drugs:
(1) Investigational drugs which are potential therapeutic advances over
currently marketed products from the standpoint of safety or effectiveness, or
which pose significant safety hazards, or which present narrow benefit-risk
considerations requiring a close judgmental decision on approval for marketing,
or which have a novel delivery system or formulation, or which are the subject
of major scientific or public controversy, or which may be subject to special
regulatory requirements such as a limitation on clinical trials, a patient
followup requirement, postmarketing Phase IV studies, distributional controls,
or boxed warnings.
(2) Marketed drugs for which an important new use has been discovered or
which pose newly discovered safety hazards, or which are the subject of major
scientific or public controversy, or which may be subject to important
regulatory actions such as withdrawal of approval for marketing, boxed warnings,
distributional controls, or newly required scientific studies.
(c) The committee may request the Commissioner for an opportunity to hold a
public hearing and to review any matter involving a human prescription drug
which falls within the pharmacologic class covered by the committee. The
Commissioner may, after consulting with the committtee on such request, grant or
deny the request in light of the priorities of the other matters pending before
the committee. Whenever feasible, consistent with the other work of the
committee, the request will be granted.
(d) For a drug that meets any of the criteria established in paragraph (b) of
this section, one or more members of or consultants to the appropriate advisory
committee may be selected for more detailed monitoring of the matter and
consultation with FDA on behalf of the committee. The member or consultant may
be invited to attend appropriate meetings and shall assist the center in any
briefing of the committee on that matter.
(e) An advisory committee may obtain advice and recommendations from other
agency advisory committees, consultants, and experts which the advisory
committee and the center conclude would facilitate the work of the advisory
committee.
(f) Presentation of all relevant information about the matter will be made in
open session unless it relates to an IND the existence of which has not
previously been disclosed to the public as defined in § 20.81 or is
otherwise prohibited from public disclosure under part 20 and the regulations
referenced therein. Sections 314.430 and 601.51 determine whether, and the
extent to which, relevant information may be made available for public
disclosure, summarized and discussed in open session but not otherwise made
available for public disclosure, or not in any way discussed or disclosed in
open session or otherwise disclosed to the public.
[44 FR 22351, Apr. 13, 1979, as amended at 54 FR 9037, Mar. 3, 1989]
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Sec. 14.172 Utilization of an advisory committee at the request of an interested
person.
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Any interested person may request, under § 10.30, that a specific
matter relating to a particular human prescription drug be submitted to an
appropriate advisory committee for a hearing and review and recommendations. The
request must demonstrate the importance of the matter and the reasons why it
should be submitted for a hearing at that time. The Commissioner may grant or
deny the request.
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Sec. 14.174 Advice and recommendations in writing.
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Advice and recommendations given by a committee on a specific drug or a class
of drugs are ordinarily in the form of a written report. The report may consist
of the approved minutes of the meeting or a separate written report. The report
responds to the specific issues or questions which the Commissioner has
addressed to the advisory committee, and states the basis of the advice and
recommendations of the committee.
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