FDA Hepatitis Update -

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Title: FDA Hepatitis Update -
You are receiving this message as a subscriber to the FDA hepatitis electronic list serve. The purpose of the list serve is to relay important information about viral hepatitis-related products and issues, including product approvals, significant labeling changes, safety warnings, notices of upcoming public meetings and alerts to proposed regulatory guidances for comment.

Please do not reply to this message.

FDA will be holding a meeting of its Blood Products Advisory Committee on April 28, 2011 from 8:30 a.m. to 1:00 p.m. on April 29, 2011 to discuss testing donations of Source Plasma for hepatitis B virus infection by nucleic acid testing. The meeting will be held at the Hilton Washington DC/North, 620 Perry Parkway, Gaithersburg, MD.

Background materials for this meeting will be available on the 2011 Meeting Materials, Blood Products Advisory Committee page.

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, 2011
* Oral presentations from the public will be scheduled between approximately 11:00 a.m. and 11:30 a.m.

Those individuals interested in making formal oral presentations should notify the contact person (below) on or before April 5, 2011, 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.

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, 2011.

Contact:
* Bryan Emery or Rosanna Harvey
1401 Rockville Pike, HFM-71, Rockville, MD 20852
301-827-1277
FAX: 301-827-0294
e-mail: Bryan.Emery@xxxxxxxxxxx or email: Rosanna.Harvey@xxxxxxxxxxx

* Use the FDA Advisory Committee Information Line for up-to-date information on this meeting.
1-800-741-8138 (301-443-0572 in the Washington, DC, area)
code 3014512391.

This meeting is open to the public, and there is no cost or registration required.

There is additional information available about the meeting.

Richard Klein
Office of Special Health Issues
Food and Drug Administration

Kimberly Struble
Division of Antiviral Drug Products
Food and Drug Administration


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