« on: August 13, 2011, 10:31:48 AM »
FDA U.S Food and Drug Administration Advisory Committee Meeting Announcement
Center : CBER
Date : September 22-23, 2011
Time : 8 a.m. to 5 p.m.
Location : Hilton Hotel Washington DC North
620 Perry Parkway
Gaithersburg, MD 20977
Agenda
On September 22, 2011, the committee will discuss BLA 125397, Umbilical Cord Blood, New York Blood Center, indicated for hematologic malignancies, bone marrow failure, primary immunodeficiency diseases, beta thalassemia, Hurler syndrome, Krabbe disease, and X-linked adrenoleukodystrophy. On September 23, 2011, the Committee will discuss HDE BH110018, CliniMACS CD34 Selection System, Miltenyi Biotec, for processing allogeneic HLA-matched hematopoietic progenitor cells-apheresis (HPC-C) from a related donor to obtain a CD34+ cell population intended for hematopoietic reconstitution following a myeloablative preparative regimen without the need for additional graft-vs-host disease (GVHD) prophylaxis in patients with acute myelogenous leukemia in first or second morphologic complete remission.
Meeting Materials
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 15, 2011
Oral presentations from the public will be scheduled on September 22 between approximately 11 a.m. and 12 noon and on September 23 between approximately 11:30 a.m. and 12:30 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 September 7, 2011. 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 8, 2011.
For those unable to attend in person, the meeting will also be Web cast. The Web cast will be available at the following link:
On September 22, 2011
http://fda.yorkcast.com/webcast/Viewer/?peid=637f14248dca4236a5f9a3b622e6501e1d
On September 23, 2011
http://fda.yorkcast.com/webcast/Viewer/?peid=2e8b3eb7638d42ca9652c328a854efb51d
Contact Information
Gail Dapolito or Sheryl Clark
1401 Rockville Pike, HFM-71, Rockville, MD 20852
301-827-0314
FAX: 301-827-0294
e-mail: gail.dapolito@fda.hhs.gov; sheryl.clark@fda.hhs.gov
FDA Advisory Committee Information Line
1-800-741-8138 (301-443-0572 in the Washington, DC, area)
code 3014512391. Please call the Information Line for up-to-date information on this 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.
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 Gail Dapolito 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).
http://www.fda.gov/AdvisoryCommittees/Calendar/ucm267714.htm