February 27, 2013: Vaccines and Related Biological Products Advisory Committee Meeting Announcement

Center	Date	Time	Location
CBER	February 27, 2013	February 27, 2013 between approximately 8:30 a.m. and 2:45 p.m.	National Institutes of Health (NIH) Fishers Lane Conference Center, Terrace Level, Rooms 508-510, 5635 Fishers Lane, Rockville, MD 20852.  Please enter the building through the main front entrance and take the elevators down to the T-Terrace Level.

Agenda

On February 27, 2013, the committee will meet in open session to discuss and make recommendations on the selection of strains to be included in the influenza virus vaccine for the 2013-2014 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. Background material is available on the 2013 Meeting Materials, Vaccines and Related Biological Products Advisory Committee page. 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 February 20, 2013.
• Oral presentations from the public will be scheduled between approximately 12:35 p.m. and 1:35 p.m. on February 27, 2013.  Those individuals 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 12, 2013.   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 13, 2013.

Webcast Information

CBER plans to provide a free of charge, live webcast of the February 27, 2013 meeting of the Vaccines and Related Biological Products Advisory Committee.  The link for the webcast is available at: http://videocast.nih.gov. Please click on February 27, 2013 FDA VRBPAC Meeting.          

Contact Information

• Donald Jehn or Denise Royster
  1401 Rockville Pike, HFM-71, Rockville, MD 20852
  301-827-0314
  FAX: 301-827-0294
  e-mail: Donald.Jehn@fda.hhs.gov or email: denise.royster@fda.hhs.gov
• 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.

FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm  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).