<?xml version="1.0" encoding="utf-8" standalone="no"?>
<key-projects>
  <projects>
    <title>Implement Intramural Component of MCM Regulatory Science Program</title>
    <description>Build robust intramural regulatory science program designed to address identified MCM gaps; enhance FDA’s capacity to review, monitor, and assess MCMs; and prepare and respond to public health emergencies.</description>
    <dictionary></dictionary>
    <outcome></outcome>
    <accomplishment>FDA launched the intramural component of the &lt;a href=http://www.fda.gov/EmergencyPreparedness/MedicalCountermeasures/ucm263071.htm target=”_blank”&gt;MCM Regulatory Science Program&lt;/a&gt; in FY 2011. The MCM Regulatory Science Program focuses on high-priority projects that are of value for public health and national security. To ensure that the MCM Regulatory Science Program is appropriately targeted and coordinated with priorities of the &lt;a href=http://www.phe.gov/Preparedness/mcm/phemce/Pages/default.aspx target=”_blank”&gt;Public Health Emergency Medical Countermeasures Enterprise&lt;/a&gt; (Enterprise), FDA established a Steering Committee for Advancing MCMi Regulatory Science. This Steering Committee is comprised of Enterprise partners – including NIH, CDC, BARDA, and DoD – and is charged with evaluating and approving MCM regulatory science research proposals primarily based upon alignment with Enterprise priorities and secondarily based upon scientific/technical merit and feasibility. More than 90 intramural regulatory science projects across CBER, CDER and CDRH have been funded under the MCM Regulatory Science Program through FY 2012. </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>1. Identify specific intramural research programs for funding during FY 2011</milestone-description>
        <milestone-date>7/30/2011</milestone-date>
        <milestone-status>Completed</milestone-status>
        <milestone-completion-date>6/30/2011</milestone-completion-date>
      </row>
      <row>
        <type></type>
        <milestone-description>2. Conduct an intramural portfolio review to re-assess gaps and unmet needs</milestone-description>
        <milestone-date>9/30/2011</milestone-date>
        <milestone-status>Completed</milestone-status>
        <milestone-completion-date>9/18/2011</milestone-completion-date>
      </row>
      <row>
        <type></type>
        <milestone-description>3. Identify specific intramural projects for potential FY 2012 funding, budget permitting</milestone-description>
        <milestone-date>12/30/2011</milestone-date>
        <milestone-date>&lt;i&gt;(6/30/2012)&lt;/i&gt;</milestone-date>
        <milestone-status>Completed</milestone-status>
        <milestone-completion-date>6/22/2012</milestone-completion-date>
      </row>
      <footnotes>
        <note></note>
      </footnotes>
    </table>
  </projects>
  <related-links>
    <link>
      <url>http://www.fda.gov/AboutFDA/Transparency/track/ucm237964.htm</url>
      <text>FDA-TRACK Medical Countermeasures Initiative (MCMi) Dashboard</text>
    </link>
    <link>
      <url>http://www.fda.gov/EmergencyPreparedness/MedicalCountermeasures/default.htm</url>
      <text>Medical Countermeasures Initiative (MCMi)</text>
    </link>
  </related-links>
</key-projects>਍††਍਍਍਍਍਍਍