[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR14.86]
[Page 152-153]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
PART 14 PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE--Table of Contents
Subpart E Members of Advisory Committees
Sec. 14.86 Rights and responsibilities of nonvoting members of advisory committees.
(a) A nonvoting member of an advisory committee selected to
represent and serve as a liaison with interested
[[Page 153]]
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 Sec. 14.39(a), approval of minutes under
Sec. 14.60(a), decisions on transcripts under Sec. 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 Sec.
20.61 only if the person has been appointed as a special Government
employee under Sec. 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 Sec. 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
Sec. 14.80(f).
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