[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: 21CFR14.35]
[Page 145-146]
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. 14.35 Written submissions to an advisory committee.
(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 Sec. 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
[[Page 146]]
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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