Advisory Committees

March 4, 2015: Vaccines and Related Biological Products Advisory Committee Meeting Announcement- Amendment

CenterDateTimeLocation
CBERMarch 4, 20158:30 a.m. to 3 p.m.DoubleTree Hotel by Hilton
Pinnacle Ballroom
8727 Colesville Road
Silver Spring, MD 20910

Updated 02/24/15: Updated the webcast information
Updated 01/29/15: Added the webcast information


Agenda
The committee will meet in open session to discuss and make recommendations on the selection of strains to be included in the influenza virus vaccines for the 2015-2016 influenza season.

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.

Materials for this meeting will be available at the Vaccines and Related Biological Products Advisory Committee Meeting main page.

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 February 18, 2015
  • Oral presentations from the public will be scheduled between approximately 12:40 p.m. and 1:40 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 February 9, 2015. 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 10, 2015

Webcast Information
For those who are unable to attend in person, CBER plans to provide a free of charge, live webcast of the March 4, 2015 meeting of the Vaccines and Related Biological Products Advisory Committee. The link for the webcast is available at: https://event.webcasts.com/starthere.jsp?ei=1051813, Once you have logged on, you will need to register to access the webcast. Complete the information on the left side of the screen, then press “Submit”. During the lunch break you will automatically be redirected to the afternoon link. Should you lose connection during the lunch break, please use the following link for the afternoon session (Note: It is different from the morning’s session) https://event.webcasts.com/starthere.jsp?ei=1051814. The webcast will be on-line at 7:30 a.m. EST so that you can log on and check your system. We recommend using Google Chrome as your browser. Please make sure that you have the latest version of JAVA on your computer. This is needed to view the slides. Those viewing through a MAC OS will need to use a web browser other than Google Chrome, we recommend Safari. Our dual viewer shows both the presenter and the slides on the same screen. If you have any questions or technical difficulties, please call 301-924-1556 for support.

Contact Information

  • Sujata Vijh (240-402-7107) or Denise Royster (240-402-8158),
  • FDA Advisory Committee Information Line
    1-800-741-8138 (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 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 Sujata Vijh 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). Official FR Notice

Page Last Updated: 02/24/2015
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