This document provides guidance to industry sponsors, applicants, and petitioners (referred to collectively as sponsors) who develop, prepare, or submit briefing materials that will be given to advisory committee members as background information before an open FDA advisory committee meeting. This guidance will help sponsors develop, organize, and submit advisory committee briefing materials for public release and should help minimize the time and resources spent in preparing these materials for public availability. The guidance also describes the process FDA intends to follow when we make briefing materials available to the public. In addition, the Appendices provide recommended timelines for preparing and submitting briefing materials to us.
An important goal of this guidance is to help ensure that briefing materials are made available to the public as provided under section 10(b) of the Federal Advisory Committee Act (FACA) (5 U.S.C. App. 2). The guidance includes recommendations on how to identify information that is exempt from public disclosure under the Freedom of Information Act (FOIA) (5 U.S.C. § 552).
Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All comments should be identified with the title of the guidance.