|March 1, 2016||8:00 a.m. – 5:00 p.m.||Food and Drug Administration |
10903 New Hampshire Ave.
Building 31, Room 1503B/C
Silver Spring, MD 20993
For those unable to attend in person, the meeting will also be webcast. The link for the webcast is https://collaboration.fda.gov/scienceboard0316/. Information regarding accommodations due to a disability, visitor parking, and transportation may be accessed at Public Meetings at the FDA White Oak Campus. Please note that visitors to the White Oak Campus must enter through Building 1.
The Science Board will hear about and discuss: (1) the role of opioids in pain management; (2) scientific challenges facing FDA in supporting the development of pain medications, including opioids, that have reduced risks of being abused; (3) scientific challenges facing FDA in seeking to understand the real-world use of opioids to treat pain, including the impact of opioids with potentially less risk for abuse; (4) the role that FDA plays as a part of a larger Federal, State and local response to the challenges of providing appropriate pain treatment while reducing opioid abuse; and (5) postmarket surveillance activities related to opioids. The Science Board will also receive a final report from the Centers of Excellence in Regulatory Science and Innovation (CERSI) Program Evaluation Subcommittee.
FDA intends to make the complete 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.
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 February 23, 2016.
- Oral presentations from the public will be scheduled between approximately 2:15 and 3:50 PM. Those desiring to make 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 February 23, 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 February 25, 2016.
Office of the Chief Scientist
Office of the Commissioner
Food and Drug Administration
White Oak Bldg 1, Room 3309
10903 New Hampshire Ave
Silver Spring, Maryland 20993
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 at http://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate advisory committee meeting link, or call the advisory committee information line to learn about possible modifications before coming to the meeting.
- FDA Advisory Committee Information Line 1-800-741-8138
(301-443-0572 in the Washington DC area).
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 Rakesh Raghuwanshi at (301) 796-4769 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 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).