[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: 21CFR14.31]
[Page 144.145]
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 B Meeting Procedures
Sec. 14.31 Consultation by an advisory committee with other persons.
(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
[[Page 145]]
Sec. 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 Sec. Sec. 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 Sec.
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 Sec.
14.70.
[44 FR 22351, Apr. 13, 1979, as amended at 55 FR 42703, Oct. 23, 1990]
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