- November 01-02, 2016
09:00 AM - 12:40 PM EDT
|NCTR||November 1-2, 2016||
November 1, 2016: 8:00 a.m. - 5:30 p.m. CST
November 2, 2016: 8:30 a.m. - 11:40 a.m. CST
Crowne Plaza Hotel
201 S. Shackleford Rd., Little Rock, AR 72211
On November 1, 2016, 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 Division of Bioinformatics and Biostatistics Subcommittee and the Subcommittee Site Visit Report and a response to this review. There will be the public comment session and an update from the NCTR Research Divisions.
On November 2, 2016, the Center for Biologics and Evaluation and Research, Center for Drug Evaluation and Research, Center for Devices and Radiological Health, Office of Food and Veterinary Medicine, Center for Tobacco Products, and the Center for Veterinary Medicine will each briefly discuss their center-specific research strategic needs and potential areas of collaboration.
Following an open discussion of all the information presented, the open session of the meeting will close so the SAB members can discuss personnel issues at NCTR at the end of each day.
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.
On November 1, 2016, from 8 a.m. to 5:30 p.m., and November 2, 2016, from 8 a.m. to 11:40 a.m., 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 October 25, 2016. Oral presentations from the public will be scheduled on November 1, 2016, between approximately 1:15 p.m. to 2:15 p.m. 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 October 17, 2016. 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 October 18, 2016.
Closed Committee Deliberations
On November 1, 2016, from 5:30 p.m. to 6 p.m., and November 2, 2016, from 11:40 a.m. to 12:15 p.m., 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.
Food and Drug Administration
10903 New Hampshire Ave.
Bldg. 32, Room 2208
Silver Spring, Maryland 20993-0002
Persons attending FDA's advisory committee meetings are advised that the Agency is not responsible for providing access to electrical outlets.
FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with disabilities. If you require accommodations due to a disability, please contact Donna Mendrick at least 7 days in advance of the meeting.
FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at for procedures on public conduct during advisory committee meetings.
Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2).
FDA Advisory Committee Information Line
(301-443-0572 in the Washington DC area)
Please call the Information Line for up-to-date information on this meeting.
A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the agency’s Web site and call the FDA Advisory Committee Information Line to learn about possible modifications before coming to the meeting.
Persons attending FDA’s advisory committee meetings are advised that the agency is not responsible for providing access to electrical outlets. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with disabilities. If you require accommodations due to a disability, please contact Lauren Tesh at (301) 796-9001 at least 7 days in advance of the meeting.
Answers to commonly asked questions including information regarding special accommodations due to a disability may be accessed at: Common Questions and Answers about FDA Advisory Committee Meetings.
FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at Public Conduct During FDA Advisory Committee Meetings for procedures on public conduct during advisory committee meetings.
Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app.2).