November 14-15, 2012
November 14, 2012 between approximately 8:30 a.m. and 4:00 p.m.
November 15, 2012 between approximately 8:30 a.m. and 2:30 p.m.
FDA White Oak Campus, Building 31, The Great Room (Rm 1503), White Oak Conference Center, 10903 New Hampshire Avenue, Silver Spring, MD 20993-0002.
On November 14, 2012, the committee will meet in open session to discuss and make recommendations on the safety and immunogenicity of an Influenza A (H5N1) Virus Monovalent Vaccine manufactured by GlaxoSmithKline. On November 15, 2012, the committee will meet in open session to discuss and make recommendations on the safety and efficacy of a Hepatitis B Vaccine manufactured by Dynavax.
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: http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee link.
Public Participation Information
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 7, 2012.
- Oral presentations from the public will be scheduled between approximately 1:30 p.m. and 2:00 p.m. on November 14, 2012, and between approximately 12:15 p.m. and 12:45 p.m. on November 15, 2012. 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 30, 2012. 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 31, 2012 .
CBER plans to provide a free of charge, live webcast of the November 14-15, 2012 meeting of the Vaccines and Related Biological Products Advisory Committee. While CBER is working to make webcasts available to the public for all advisory committee meetings held at the White Oak campus, there are instances where the webcast transmission is not successful; staff will work to re-establish the transmission as soon as possible. The link for the webcast is available at: https://collaboration.fda.gov/vrbpac.
- Donald Jehn or Denise Royster
1401 Rockville Pike, HFM-71, Rockville, MD 20852
e-mail: Donald.Jehn@fda.hhs.gov or email: email@example.com
- FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area)
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.
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 appropriate advisory committee hot line/phone 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 physical disabilities or special needs. If you require special accommodations due to a disability, please contact Donald Jehn or Denise Royster at least 7 days in advance of the meeting.
Information regarding special accommodations due to a disability, visitor parking and transportation may be accessed at: http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.
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).