Title 21
SECTION 14.35
14.35 Written submissions to an advisory committee.
§ 14.35 Written submissions to an advisory committee.(a) Ten copies of written submissions to a committee are to be sent to the Designated Federal Officer 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 Designated Federal Officer 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 Designated Federal Officer 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.