<?xml version="1.0" encoding="utf-8" standalone="no"?>
<key-projects>
  <projects>
    <title>Pioneer and Generic Animal Drug User Fees Renegotiations</title>
    <description>Provide proposal package to Congress outlining the recommendations for reauthorization of the A/GDUFA programs to continue to collect fees for certain animal drug applications, and for the establishments, products and sponsors associated with these and previously approved animal drug applications, in support of the review of pioneer and generic animal drugs. (1)</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. Gather feedback on suggestions regarding reauthorization including specific suggestions for changes to the A/GDUFA goals, hold a public meeting and open a docket to gather written comments</milestone-description>
        <milestone-date>11/7/2011</milestone-date>
        <milestone-status>Completed</milestone-status>
        <milestone-completion-date>11/7/2011</milestone-completion-date>
      </row>
      <row>
        <type>main</type>
        <milestone-description>2. Analyze written comments submitted to the docket to inform stakeholder and industry discussions</milestone-description>
        <milestone-date>12/30/2011</milestone-date>
        <milestone-status>Completed</milestone-status>
        <milestone-completion-date>12/7/2011</milestone-completion-date>
      </row>
      <row>
        <type>main</type>
        <milestone-description>3. Conduct periodic consultations with representatives of veterinary, patient, and consumer advocacy groups to continue discussions of their views on reauthorization and their suggestions for changes</milestone-description>
        <milestone-date>5/30/2012</milestone-date>
        <milestone-date>&lt;i&gt;(7/31/2012)&lt;/i&gt;</milestone-date>
        <milestone-status>Completed</milestone-status>
        <milestone-completion-date>7/19/2012</milestone-completion-date>
      </row>
      <row>
        <type>main</type>
        <milestone-description>4. Conduct negotiations and reach agreement with the regulated industry on user fee program reauthorizations</milestone-description>
        <milestone-date></milestone-date>
        <milestone-status></milestone-status>
        <milestone-completion-date></milestone-completion-date>
      </row>
      <row>
        <type>sub</type>
        <milestone-description>a. ADUFA Program</milestone-description>
        <milestone-date>7/24/2012</milestone-date>
        <milestone-status>Completed</milestone-status>
        <milestone-completion-date>7/24/2012</milestone-completion-date>
      </row>
      <row>
        <type>sub</type>
        <milestone-description>b. AGDUFA Program</milestone-description>
        <milestone-date>6/30/2012</milestone-date>
        <milestone-status>Completed</milestone-status>
        <milestone-completion-date>4/19/2012</milestone-completion-date>
      </row>
      <row>
        <type>main</type>
        <milestone-description>5. Submit draft package of proposal recommendations for reauthorizations for administration review and clearance</milestone-description>
        <milestone-date>8/1/2012</milestone-date>
        <milestone-date>&lt;i&gt;(10/15/2012)&lt;/i&gt;</milestone-date>
        <milestone-status>Completed</milestone-status>
        <milestone-completion-date>9/13/2012</milestone-completion-date>
      </row>
      <row>
        <type>main</type>
        <milestone-description>6. Publish draft proposed recommendations in Federal Register and provide 30-day comment period</milestone-description>
        <milestone-date>9/15/2012</milestone-date>
        <milestone-date>&lt;i&gt;(10/19/2012)&lt;/i&gt;</milestone-date>
        <milestone-status>Completed</milestone-status>
        <milestone-completion-date>12/5/2012</milestone-completion-date>
      </row>
      <row>
        <type>main</type>
        <milestone-description>7. Hold a public meeting to gather feedback on the proposed recommendations for reauthorization</milestone-description>
        <milestone-date>11/1/2012</milestone-date>
        <milestone-date>&lt;i&gt;(11/20/2012)&lt;/i&gt;</milestone-date>
        <milestone-status>Completed</milestone-status>
        <milestone-completion-date>12/18/2012</milestone-completion-date>
      </row>
      <row>
        <type>main</type>
        <milestone-description>8. Revise recommendations as necessary per public input</milestone-description>
        <milestone-date>12/15/2012</milestone-date>
        <milestone-date>&lt;i&gt;(12/31/2012)&lt;/i&gt;</milestone-date>
<milestone-date>&lt;i&gt;(1/14/2013)&lt;/i&gt;</milestone-date>
        <milestone-status>Completed</milestone-status>
        <milestone-completion-date>1/9/2013</milestone-completion-date>
      </row>
      <row>
        <type>main</type>
        <milestone-description>9. Transmit final package of prepared recommendations for reauthorization to Congress by January 15, 2013</milestone-description>
        <milestone-date>1/15/2013</milestone-date>
        <milestone-status>Not Yet Started</milestone-status>
        <milestone-completion-date></milestone-completion-date>
      </row>
      <footnotes>
        <note>(1) The dates in italics under the milestone due dates are modified due dates which had to be updated due to real-time delays. The milestone status reflects the modified dates.</note>
      </footnotes>
    </table>
  </projects>
  <glossary>
    <word>
      <text></text>
      <definition></definition>
    </word>
    <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>਍††਍਍਍਍਍਍਍