The Open Public Hearing at FDA Advisory Committee Meetings Guidance for the Public, FDA Advisory Committee Members, and FDA Staff May 2013
The Food and Drug Administration’s (FDA’s) advisory committees play an essential role in FDA’s activities to protect and promote public health through the regulation of human and animal drugs, biological products, medical devices, foods, and tobacco products. FDA’s advisory committees provide independent expert advice and recommendations to the Agency on scientific, technical, and policy matters related to FDA-regulated products. Advisory committees enhance FDA’s ability to protect and promote public health by ensuring FDA has access to such advice through the public hearing process as provided in existing laws and regulations. Although advisory committees provide recommendations to FDA, FDA makes the final decisions on any matters considered by an advisory committee. General procedures for FDA advisory committees are described at 21 CFR Part 14.
FDA encourages participation from all public stakeholders in its decision-making processes. Every advisory committee meeting includes an open public hearing (OPH) session, during which interested persons may present relevant information or views orally or in writing ( 21 CFR 14.25(a)). FDA’s regulation, 21 CFR 14.29, requires that a minimum of 60 minutes per meeting be dedicated to an OPH session for oral presentations, unless public participation does not last that long. For meetings that extend more than 1 day and/or meetings with multiple topics, the OPH session can be divided into multiple parts. If there is an overwhelming interest by the advisory committee in a specific topic, then the committee chair may extend the OPH session. The time and location of the meeting and the OPH session is published in the Federal Register (21 CFR 14.20) at least 15 days before a meeting.
This guidance is intended to answer questions about how the public may participate at an OPH session. This includes, but is not limited to, general members of the public; individuals or spokespersons from the regulated industry (except the sponsor whose product is under review); consumer advocacy groups; and professional organizations, societies, or associations.
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.