Disclosure of Materials Provided to Advisory Committees in Connection with Open Advisory Committee Meetings Convened by the Center for Drug Evaluation and Research Beginning on January 1, 2000

Issue Date: December 22, 1999
Issued by: Center for Drug Evaluation and Research
Topic(s): Administrative / Procedural
Status: Final

Disclosure of Materials Provided to Advisory Committees in Connection with Open Advisory Committee Meetings Convened by the Center for Drug Evaluation and Research Beginning on January 1, 2000

This document provides guidance on how FDA interprets the Federal Advisory Committee Act (FACA) (5 U.S.C. App. 2) and 21 CFR 314.430 (§ 314.430) with respect to the disclosure of materials provided to advisory committees, and how FDA will exercise its discretion under § 314.430(d)(1)2 in connection with open advisory committee meetings convened by the Center for Drug Evaluation and Research (CDER) beginning on January 1, 2000. FDA construes the FACA to require that, with respect to any open advisory committee meeting convened pursuant to the FACA, whenever practicable and subject to any applicable exemptions of the Freedom of Information Act (FOIA) (5 U.S.C. § 552), those materials that are provided to the members of an advisory committee in connection with that meeting must be made available for public inspection and copying before or at the time of the advisory committee meeting. FDA interprets § 314.430 to be consistent with the FACA and therefore will exercise its discretion under § 314.430(d)(1) in a manner consistent with the FACA and the FOIA as described in the previous sentence to make available for public inspection and copying materials provided to the members of an advisory committee in connection with open advisory committee meetings convened by CDER, beginning on January 1, 2000.

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