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What is an advisory committee?

Advisory committees provide independent expert advice to the FDA on broad scientific topics or on certain products to help the agency make sound decisions based on the available science. Advisory committees make non-binding recommendations to the FDA, which generally follows the recommendations but is not legally bound to do so. Please see, "Advisory Committees Give FDA Critical Advice and the Public a Voice," for more information.

NCTR’s Science Advisory Board (SAB) meeting will be held at the Heifer Center in Little Rock on December 3-4, 2019, ending at approximately noon on December 4th. This is a public meeting.  

Agenda

On December 3, 2019, the SAB Chair will welcome the participants, and the NCTR Director will provide a Center-wide update on scientific initiatives and accomplishments during the past year. The SAB will be presented with an overview of the SAB Subcommittee Site Visit Report and a response to this review. There will be a statement given by the FDA Chief Scientist.  The Center for Biologics and Evaluation and Research, Center for Drug Evaluation and Research, Center for Devices and Radiological Health, Center for Food Safety and Applied Nutrition, Center for Tobacco Products, Center for Veterinary Medicine and the Office of Regulatory Affairs will each briefly discuss their center-specific research strategic needs and potential areas of collaboration.  There will be a public comment period in-between these Center presentations.  There will be updates from the NCTR Research Divisions on December 3-4, 2019.  On December 4, there will be open discussion of all the information presented and then the open session of the meeting will close so the SAB members can discuss personnel issues at NCTR.

Meeting Materials

FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA's Web site after the meeting. Background material is available at Advisory Committees. Scroll down to the appropriate advisory committee meeting link.

Procedure

On December 3, 2019, from 8 a.m. to 5:55 p.m. (CST), and December 4, 2019, from 8:00 a.m. to 11:30 a.m. (CST), the meeting is open to the public. Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person on or before November 18, 2019. Oral presentations from the public will be scheduled between approximately 1:00 p.m. and 2:00 p.m. (CST). Those individuals interested in making formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before November 18, 2019. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by November 20, 2019.

Closed Committee Deliberations

On December 4, 2019, from 11:30 a.m. to 12:00 p.m. (CST), the meeting will be closed to permit discussion where disclosure would constitute a clearly unwarranted invasion of personal privacy (5 U.S.C. 552b(c)(6)). This portion of the meeting will be closed to permit discussion of information concerning individuals associated with the research programs at NCTR.
 

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