September 19, 2012: Vaccines and Related Biological Products Advisory Committee Meeting Announcement

Center	Date	Time	Location
CBER	September 19, 2012	September 19, 2012 between approximately 8:00 a.m. and 4:00 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.

Agenda

On September 19, 2012, the committee will meet in open session to discuss consideration of the appropriateness of cell lines derived from human tumors for vaccine manufacture.  

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 2012 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 September 12, 2012.
• Oral presentations from the public will be scheduled between approximately 1:30 p.m. and 2:30 p.m. on September 19, 2012. 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 September 4, 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 September 5, 2012 .

Webcast Information

CBER plans to provide a free of charge, live webcast of the September 19, 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/.

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.

Information regarding special accommodations due to a disability, visitor parking and transportation may be accessed on the Public Meetings at the FDA White Oak Campus page.

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).