<?xml version="1.0" encoding="utf-8" standalone="no"?>
<key-projects>
  <projects>
    <title>Development of XML Files for Releasable CVM ADE Data</title>
    <description>Provide public access to current CVM ADE data in a harmonized format accessible for data mining technologies.  This objective will be supported on an ongoing basis with quarterly updates.  Non-public data will not be included in the release.</description>
    <dictionary></dictionary>
    <outcome></outcome>
    <accomplishment></accomplishment>
    <free-text></free-text>
    <table>
      <title></title>
      <free-text-table></free-text-table>
      <overall-status>
        <briefing>ON TRACK</briefing>
        <prior-briefing>ON TRACK</prior-briefing>
      </overall-status>
      <row>
        <type>main</type>
        <milestone-description>1. Submit Configuration Change Request (CCR) for creation of XML files</milestone-description>
        <milestone-date>8/1/2011</milestone-date>
        <milestone-status>Completed</milestone-status>
        <milestone-completion-date>7/13/2011</milestone-completion-date>
      </row>
      <row>
        <type>main</type>
        <milestone-description>2. Create XML and ReadMe Text Files</milestone-description>
        <milestone-date>12/1/2012</milestone-date>
        <milestone-date>&lt;i&gt;(12/1/2013)&lt;/i&gt;</milestone-date>
        <milestone-status>On Track</milestone-status>
        <milestone-completion-date></milestone-completion-date>
      </row>
      <row>
        <type>sub</type>
        <milestone-description>a. Implement pre-existing CCR for data migration of all historical Submission Tracking and Reporting System (STARS) data into the PV Works database.  This is CRITICAL to success as the data migration includes mapping of non-harmonized medical coding to harmonized Veterinary Medicinal Dictionary for Drug Regulatory Authorities (VedDRA) coding.  VedDRA coding is only supported in the PV Works database.  A continuation of this CCR to include a quarterly data migration will be necessary as data entry of ADE reports received on paper continues in the STARS system.</milestone-description>
        <milestone-date>12/1/2012</milestone-date>
        <milestone-date>&lt;i&gt;(12/1/2013)&lt;/i&gt;</milestone-date>
        <milestone-status>On Track</milestone-status>
        <milestone-completion-date></milestone-completion-date>
      </row>
      <row>
        <type>sub</type>
        <milestone-description>b. Create XML files from PV Works database with IT support and development and clearance of an accompanying ReadMe text file for initial release of cumulative ADE data, to be followed by quarterly updates (may need “continuing CCR”)</milestone-description>
        <milestone-date>12/1/2012</milestone-date>
        <milestone-date>&lt;i&gt;(12/1/2013)&lt;/i&gt;</milestone-date>
        <milestone-status>On Track</milestone-status>
        <milestone-completion-date></milestone-completion-date>
      </row>
      <row>
        <type>main</type>
        <milestone-description>3. Website Development:</milestone-description>
        <milestone-date></milestone-date>
        <milestone-status></milestone-status>
        <milestone-completion-date></milestone-completion-date>
      </row>
      <row>
        <type>sub</type>
        <milestone-description>a. Develop Format and Content of the Hosting Web Page</milestone-description>
        <milestone-date>4/1/2013</milestone-date>
        <milestone-date>&lt;i&gt;(4/1/2014)&lt;/i&gt;</milestone-date>
        <milestone-status>Not Yet Started</milestone-status>
        <milestone-completion-date></milestone-completion-date>
      </row>
      <row>
        <type>sub</type>
        <milestone-description>b. Complete clearance process for Web Page Content</milestone-description>
        <milestone-date>4/1/2013</milestone-date>
        <milestone-date>&lt;i&gt;(4/1/2014)&lt;/i&gt;</milestone-date>
        <milestone-status>Not Yet Started</milestone-status>
        <milestone-completion-date></milestone-completion-date>
      </row>
      <row>
        <type>sub</type>
        <milestone-description>c. Develop CVM update announcing project with Communications Staff</milestone-description>
        <milestone-date>4/1/2013</milestone-date>
        <milestone-date>&lt;i&gt;(4/1/2014)&lt;/i&gt;</milestone-date>
        <milestone-status>Not Yet Started</milestone-status>
        <milestone-completion-date></milestone-completion-date>
      </row>
      <row>
        <type>main</type>
        <milestone-description>4. Launch CVM website access to the public</milestone-description>
        <milestone-date>6/1/2013</milestone-date>
        <milestone-date>&lt;i&gt;(6/1/2014)&lt;/i&gt;</milestone-date>
        <milestone-status>Not Yet Started</milestone-status>
        <milestone-completion-date></milestone-completion-date>
      </row>
      <row>
        <type>sub</type>
        <milestone-description>a. Release CVM update</milestone-description>
        <milestone-date>6/1/2013</milestone-date>
        <milestone-date>&lt;i&gt;(6/1/2014)&lt;/i&gt;</milestone-date>
        <milestone-status>Not Yet Started</milestone-status>
        <milestone-completion-date></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/ucm203425.htm</url>
      <text>FDA-TRACK CVM Dashboard</text>
    </link>
  </related-links>
</key-projects>਍††਍਍਍਍਍਍਍