FDA Blood Products Advisory Committee to hear about XMRV

[natasa778]

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.

 

[Rrrr]

is anyone in washington dc or maryland able to attend and protest outside or inside?

rrrr

 

[Rrrr]

this seems really important to get someone with cfs there to comment during their public comment time! can anyone do this?

 

[ixchelkali]

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 FDAs 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 agencys Web site and call the appropriate advisory committee hot line/phone line to learn about possible modifications before coming to the meeting.

Persons attending FDAs 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 Bryan Emery or Pearline Muckelvene 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.

http://www.fda.gov/AdvisoryCommittees/Calendar/ucm216470.htm

- - - - - - - - - - - - - - - - - - - - - - -
Public Conduct During FDA Advisory Committee Meetings

The FDA would like to ensure that advisory committee meetings proceed in an orderly fashion, are conducted in a safe and secure environment, that the right of free speech is protected, and that the ability of FDA Advisory Committees and Panels to accomplish their objectives is not disrupted. Therefore, the following procedures will be followed:

An interested person who wishes to be assured of the right to make an oral presentation during the Open Public Hearing portion of an advisory committee meeting should register with FDA before the meeting. See 21 CFR 14.29(b). Those who have not registered before the meeting will only be invited to speak at the discretion of the Chair, and should submit their request to FDA officials at the registration desk on the day of the meeting.

Open Public Hearing participants who are designated to speak may be questioned only by the Chair or other members of the Committee.

Audience members may not present comments or questions to the Committee unless recognized by the Chair.

Attendees may be subject to security screening, such as presenting identification, passing through metal detectors, and inspection of briefcases, packages, etc.

Attendees at the meeting are asked to maintain order and not display behavior that is disruptive to the meeting (i.e., shouting from the audience, loud outbursts).

The committee Chair or Designated Federal Officer will note on the record any disruptive behavior and will ask the person to cease the behavior or else leave the meeting room.

We ask that attendees not approach the advisory committee table area before, during, or after the meeting without permission from a Designated Federal Officer/Executive Secretary.

http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm

 

[ixchelkali]

It would be nice if we could at least ask for an update on the status of the development of a standardized test for XMRV which could be used to determine prevalence in the blood supply.

"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 there is no one able to attend in person, perhaps we could ask to be allowed to present our questions in writing ahead of time, as a way of "accommodating persons with physical disabilities or special needs." They say they'll "make every effort," and that wouldn't require a great deal of effort on their part.