|CBER||July 20-21, 2009||On July 20, 2009 from 8:00 a.m. to 6:00 p.m. and on July 21, 2009 from 9:00 a.m. to 12:00 p.m.||Hilton Washington DC North/Gaithersburg, Grand Ballroom, 620 Perry Parkway, Gaithersburg, Maryland 20877|
On July 20, 2009, in the morning, the Committee will review proposed strategies to demonstrate the effectiveness of new coral snake antivenoms. In the afternoon the Committee will discuss alternative clinical and surrogate endpoints for evaluating efficacy of Alpha-1 Proteinase Inhibitor (Human) augmentation therapy in Alpha-1 antitrypsin deficiency. Alpha-1 antitrypsin deficiency is a genetic condition associated with decreased circulating levels of alpha-1 antitrypsin that significantly increases the risk of serious lung disease (i.e. emphysema) in adults. On July 21, 2009 the Committee will hear updates on the following topics: April 30-May 1, 2009 meeting of the DHHS Advisory Committee on Blood Safety and Availability; June 12, 2009 meeting of the FDA Transmissible Spongiform Encephalopathies Advisory Committee; and an overview of the epidemiology and virology of the 2009 A/H1N1 influenza virus and its impact on the U.S blood system. The Committee will also hear informational presentations on recent public and private hemovigilance efforts, including the pilot hemovigilance module in the National Healthcare Safety Network.
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 15, 2009.
- Oral presentations from the public will be scheduled between approximately 10:30 a.m. and 11:00 a.m. and between approximately 3:45 p.m. and 5:00 p.m. on July 20, 2009, and between approximately 11:30 a.m. and 12:00 p.m. on July 21, 2009. 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 13, 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. The contact person will notify interested persons regarding their request to speak by July 14, 2009.
- William Freas, Ph.D.
1401 Rockville Pike, HFM-71, Rockville, MD 20852
- FDA Advisory Committee Information Line
1-800-741-8138 (301-443-0572 in the Washington, DC, area)
Please call the Information Line for up-to-date information on this meeting.
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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.
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Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2).