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Joint Meeting of the Pediatric Advisory Committee and the Oncologic Drugs Advisory Committee

Agenda

On Monday, April 27, 2009, the Pediatric Advisory Committee and the Oncologic Drugs Advisory Committee will meet to discuss the scientific and ethical issues involved in obtaining and using brain biopsy specimens to evaluate gene expression patterns in children with diffuse pontine gliomas.

Meeting Materials

Meeting materials will be added as they become available at http://www.fda.gov/ohrms/dockets/ac/oc09.html#pac

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 April 13, 2009.
• Oral presentations from the public will be scheduled aproximately between 1 p.m and 2 p.m. 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 April 3, 2009.

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 April 6, 2009.

Contact Information

• Carlos Pena, Ph.D.
  Office of Commissioner, HF-33
  Food and Drug Administration
  5600 Fishers Lane, Rm 14B-08
  Rockville, MD 20857
  
  301-827-3340
  e-mail: Carlos.Pena@fda.hhs.gov
• FDA Advisory Committee Information Line
  1-800-741-8138
  (301-443-0572 in the Washington, DC, area)
  code 8732310001
  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.

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/ohrms/dockets/ac/acmenu.htm, click on the year 2009 and scroll down to the appropriate advisory committee link.

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 Carlos Pena 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/oc/advisory/default.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.).

Last Updated on April 9, 2009

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