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<key-projects><projects><title>Tuberculosis Initiative</title><description>Facilitate the development of medical products, including vaccines, for the diagnosis, prevention, and treatment of tuberculosis (TB), including resistant TB. This will hasten development of new drugs for drug-resistant and drug-sensitive TB, and may facilitate shortening of therapy. It will provide the public with new diagnostic tests to determine durable cure in TB, to identify drug resistance early and expedite appropriate therapy, and to diagnose TB in children. The office leads this project in coordination with CDER, CBER, and CDRH.</description><dictionary></dictionary><outcome></outcome><accomplishment>Critical Path's June 7, 2010 &lt;a href=http://www.fda.gov/ScienceResearch/SpecialTopics/CriticalPathInitiative/UpcomingEventsonCPI/ucm203262.htm target=”_blank”&gt;TB Diagnostic Workshop&lt;/a&gt; drew more than 150 participants from around the world. Consensus was reached on priority areas for research. The meeting report &lt;a href=http://fdamedlibmd.library.ingentaconnect.com/content/iuatld/ijtld/2011/00000015/00000007/art00023 target=”_blank”&gt; Advancing the development of diagnostic tests and biomarkers for tuberculosis&lt;/a&gt; was co-authored by FDA experts and published in the International Journal of Tuberculosis and Lung Disease (IJTLD). An RFA was published with numerous responses. A review committee comprising members within and outside FDA awarded funding to &lt;a href=http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2010/ucm228250.htm target=”_blank”&gt; six applicants&lt;/a&gt; on September 22, 2010.  A grant-holder meeting was held at FDA on March 29, 2011, at which scientific presentations were given to a broad FDA audience, and areas for collaboration between the programs were identified. As a result, progress reports from the awardees are being evaluated to determine ongoing funding.</accomplishment><free-text></free-text><table><title></title><free-text-table></free-text-table><overall-status><briefing></briefing><prior-briefing></prior-briefing></overall-status><row><type></type><milestone-description>A. Create FDA TB working group</milestone-description><milestone-date>3/31/2010</milestone-date><milestone-status>Completed</milestone-status><milestone-completion-date>3/15/2010</milestone-completion-date></row><row><type></type><milestone-description>B. Plan and conduct a workshop on developing TB diagnostics, with broad participation from U.S. government agencies, and local and international stakeholders in TB diagnostic development</milestone-description><milestone-date>6/30/2010</milestone-date><milestone-status>Completed</milestone-status><milestone-completion-date>6/7/2010-6/8/2010</milestone-completion-date></row><row><type></type><milestone-description>C. Develop content and issue Request for Applications addressing appropriations language</milestone-description><milestone-date>7/1/2010</milestone-date><milestone-status>Completed</milestone-status><milestone-completion-date>7/14/2010</milestone-completion-date></row><row><type></type><milestone-description>D. Establish committee and procedure for review of applications/award grants</milestone-description><milestone-date>7/30/2010</milestone-date><milestone-status>Completed</milestone-status><milestone-completion-date>9/10/2010</milestone-completion-date></row><row><type></type><milestone-description>E. Make awards</milestone-description><milestone-date>9/30/2010</milestone-date><milestone-status>Completed</milestone-status><milestone-completion-date>9/22/2010</milestone-completion-date></row><row><type></type><milestone-description>F. Hold Awardee meeting to share progress and facilitate collaboration</milestone-description><milestone-date>3/31/2011</milestone-date><milestone-status>Completed</milestone-status><milestone-completion-date>3/29/2011</milestone-completion-date></row><row><type></type><milestone-description>G. Identify collaborative expansion of TB awards program</milestone-description><milestone-date>9/30/2011</milestone-date><milestone-status>Completed</milestone-status><milestone-completion-date>3/29/2011</milestone-completion-date></row><footnotes><note></note></footnotes></table></projects><glossary><word><text></text><definition></definition></word></glossary><related-links><link><url>http://www.fda.gov/AboutFDA/Transparency/track/ucm206688.htm</url><text>FDA-TRACK OC Office of the Chief Scientist Dashboard</text></link></related-links></key-projects>
    






