|OC||June 4, 2014||8:30 a.m. - 4:30 p.m.||
Food and Drug Administration
For those unable to attend in person, the meeting will also be webcast. The link for the webcast is available at https://collaboration.fda.gov/scienceboard. Information regarding special accommodations due to a disability, visitor parking, and transportation may be accessed at: http://www.fda.gov/AdvisoryCommittees/default.htm; under the heading "Resources for You," click on "Public Meetings at the FDA White Oak Campus." Please note that visitors to the White Oak Campus must enter through Building 1.
On June, 4, 2014, the Science Board will discuss and make recommendations on the draft final report from CBER's post-marketing safety review subcommittee. The committee will be asked to support forming a new subcommittee to evaluate the Commissioner's Fellowship Program. The committee will be presented with an overview of current issues surrounding heparin sourcing for discussion. A recipient of one of the FY2013 Scientific Achievement Awards (selected by the Board) will provide an overview of the activities for which the award was given.
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.
- Background material
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 Wednesday, May 28, 2014.
- Oral presentations from the public will be scheduled between 3 p.m. and 4 p.m. on June 4, 2014. 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 Tuesday, May 20, 2014.
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 Wednesday May 21, 2014.
Office of Chief Scientist
Office of the Commissioner
Food and Drug Administration
White Oak Bldg 32, Room 4286
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) and follow the prompts to the desired center or product area.
Please call the Information Line for up-to-date information on this 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 physical disabilities or special needs. If you require special accommodations due to a disability, please contact Martha Monser at (301) 796-4627 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).