[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2004]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR14.35]

[Page 177]
 
                        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 
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.