BLOOD PRODUCTS ADVISORY COMMITTEE
CBER July 26-27, 2010 July 26 from 8 a.m. to approximately 5:30 p.m.
July 27 from 8 a.m. to approximately 1 p.m. Hilton Washington DC/North,
620 Perry Pkwy., Gaithersburg, MD
Agenda
On July 26, in the morning session, the Committee will hear updates on the following topics: June 10-11, 2010 meeting of the HHS Advisory Committee on Blood Safety and Availability; December 14-15, 2009 FDA workshop on emerging arboviruses; May 11-12, 2010 FDA workshop on emerging infectious diseases; and the Q fever epidemic in the Netherlands. The Committee will also hear informational presentations on Xenotropic Murine Leukemia Virus-Related Virus (XMRV). In the afternoon session, the Committee will discuss issues related to the risk of Babesia infection by blood transfusions and the status of laboratory tests. On July 27, the Committee will discuss blood donor hemoglobin/hematocrit qualifications standards, iron status and interdonation interval.
Meeting Materials
Materials for this meeting will be available on the 2010 Meeting Materials Blood Products Advisory Committee page.
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 July 19, 2010
* Oral presentations from the public will be scheduled between approximately 11:45 a.m. and 12:30 p.m. and between 4 p.m. and 4:45 p.m. on July 26 and between approximately 10:30 a.m. and 11 a.m. on July 27. 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 July 9, 2010. 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 July 12, 2010.
Contact Information
* Bryan Emery or Pearline K. Muckelvene
1401 Rockville Pike, HFM-71, Rockville, MD 20852
301-827-1295
FAX: 301-827-0294
e-mail: Bryan.Emery@fda.hhs.gov or email: pearline.muckelvene@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.
CBER July 26-27, 2010 July 26 from 8 a.m. to approximately 5:30 p.m.
July 27 from 8 a.m. to approximately 1 p.m. Hilton Washington DC/North,
620 Perry Pkwy., Gaithersburg, MD
Agenda
On July 26, in the morning session, the Committee will hear updates on the following topics: June 10-11, 2010 meeting of the HHS Advisory Committee on Blood Safety and Availability; December 14-15, 2009 FDA workshop on emerging arboviruses; May 11-12, 2010 FDA workshop on emerging infectious diseases; and the Q fever epidemic in the Netherlands. The Committee will also hear informational presentations on Xenotropic Murine Leukemia Virus-Related Virus (XMRV). In the afternoon session, the Committee will discuss issues related to the risk of Babesia infection by blood transfusions and the status of laboratory tests. On July 27, the Committee will discuss blood donor hemoglobin/hematocrit qualifications standards, iron status and interdonation interval.
Meeting Materials
Materials for this meeting will be available on the 2010 Meeting Materials Blood Products Advisory Committee page.
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 July 19, 2010
* Oral presentations from the public will be scheduled between approximately 11:45 a.m. and 12:30 p.m. and between 4 p.m. and 4:45 p.m. on July 26 and between approximately 10:30 a.m. and 11 a.m. on July 27. 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 July 9, 2010. 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 July 12, 2010.
Contact Information
* Bryan Emery or Pearline K. Muckelvene
1401 Rockville Pike, HFM-71, Rockville, MD 20852
301-827-1295
FAX: 301-827-0294
e-mail: Bryan.Emery@fda.hhs.gov or email: pearline.muckelvene@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.