FDA to Discuss DIPG Biopsies

On April 27, 2009, the 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.

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Joint Meeting of the Pediatric Advisory Committee and the Oncologic Drugs Advisory Committee
This meeting is open to the public.

Date and Time of Meeting:
April 27, 2009, from 8 a.m. to 6 p.m.

Date and Time of the Open Public Hearing:
April 27, 2009, between approximately 1 p.m. and 2 p.m.

Deadline to Request Speaking during Open Public Hearing:
On or before April 3, 2009 (see "How to Participate in the Open Public Hearing" below)

Address of Meeting:
Washington DC North/Gaithersburg Hilton,
620 Perry Pkwy.,
Gaithersburg, MD 20877.

Contact Person:
Carlos Pena
Office of the Commissioner (HF-33)
Food and Drug Administration,
5600 Fishers Lane (for express delivery, rm. 14B-08)
Rockville, MD 20857,
301-827-3340
or
e-mail: carlos.pena@fda.hhs.gov

Agenda:
On April 27, 2009, the 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.

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.

How to Participate in the Open Public Hearing:
Oral presentations from the public will be scheduled between approximately 1 p.m. and 2 p.m. on April 27, 2009.

Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Notify the contact person (listed above) on or before April 3, 2009, if you would like to make a formal oral presentations the day of the meeting. 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. The contact person (listed above) will notify interested persons regarding their request to speak by April 6, 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.

Written submissions may be made to the contact person (listed above) on or before April 13, 2009.

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 notify the contact person (listed above) 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.