<?xml version="1.0" encoding="utf-8" standalone="no"?>
<key-projects>
  <projects>
    <title>Mechanisms of Monoamine Neurotoxicity</title>
    <description>Defining mechanisms of CNS stimulant toxicity. This study is a collaborative effort with CDER.</description>
    <dictionary>Norepinephrine functions as both a hormone and a neurotransmitter. As a hormone, it underlies the flight-or-fight response. As a drug it will increase blood pressure. One element in this study involves an examination of how norepinphrine affects the genome.</dictionary>
    <dictionary>Another element of this study is the acquisition and use of a confocal microscope which will allow researchers to obtain higher quality microscopic images with the ability to reconstruct three-dimensional images.</dictionary>
    <dictionary>These studies will provide information on ways to minimize risk associated with the use of CNS stimulants.</dictionary>
    <outcome>These studies will provide information on ways to minimize risk associated with the use of CNS stimulants.</outcome>
    <accomplishment></accomplishment>
    <table>
      <title>1. Genomic Evaluation of CNS Blood Vessels</title>
      <overall-status>
        <briefing>ON TRACK</briefing>
        <prior-briefing>ON TRACK</prior-briefing>
      </overall-status>
      <row>
        <type>main</type>
        <milestone-description>a. Complete study on genomic evaluation of norepinephrine modulation of CNS blood vessels</milestone-description>
        <milestone-date>10/31/2009</milestone-date>
        <milestone-status>Completed</milestone-status>
        <milestone-completion-date>11/15/2009</milestone-completion-date>
      </row>
      <row>
        <type>main</type>
        <milestone-description>b. Complete assessment of research findings</milestone-description>
        <milestone-date>11/15/2010</milestone-date>
        <milestone-status>Completed</milestone-status>
        <milestone-completion-date>11/15/2010</milestone-completion-date>
      </row>
      <row>
        <type>main</type>
        <milestone-description>c. Develop draft technical report/manuscript/publication on genomic evaluation of norepinephrine modulation of CNS blood vessels</milestone-description>
        <milestone-date>12/1/2010</milestone-date>
        <milestone-status>Completed</milestone-status>
        <milestone-completion-date>12/1/2010</milestone-completion-date>
      </row>
      <row>
        <type>main</type>
        <milestone-description>d. Complete the peer review (NCTR and other FDA researchers) of draft technical report, manuscript, and/or publication</milestone-description>
        <milestone-date>2/1/2011</milestone-date>
        <milestone-status>Completed</milestone-status>
        <milestone-completion-date>3/4/2011</milestone-completion-date>
      </row>
      <row>
        <type>main</type>
        <milestone-description>e. Obtain NCTR Center Director approval on the draft technical report, manuscript, and/or publication via the document tracking system</milestone-description>
        <milestone-date>3/1/2011</milestone-date>
        <milestone-status>Completed</milestone-status>
        <milestone-completion-date>2/15/2012</milestone-completion-date>
      </row>
      <row>
        <type>main</type>
        <milestone-description>f. Submit final technical report, manuscript, and/or publication on genomic evaluation of norepinephrine modulation of CNS blood vessels to a scientific journal</milestone-description>
        <milestone-date>5/15/2012</milestone-date>
        <milestone-date>&lt;i&gt;(FY13 Q2)&lt;/i&gt;</milestone-date>
        <milestone-status>On Track</milestone-status>
        <milestone-completion-date></milestone-completion-date>
      </row>
      <footnotes>
        <note></note>
      </footnotes>
    </table>
    <table>
      <title>2. Amphetamine and Methamphetamine Studies</title>
      <overall-status></overall-status>
      <free-text-table>This project was terminated due to an unacceptably high risk to laboratory animals.</free-text-table>
      <row>
        <type>main</type>
        <milestone-description>a. Submit protocol for remote monitoring for comparing the effects on body temperature and blood pressure in laboratory animals exposed to amphetamine or methamphetamine</milestone-description>
        <milestone-date>3/31/2010</milestone-date>
        <milestone-status>Completed</milestone-status>
        <milestone-completion-date>3/24/2010</milestone-completion-date>
      </row>
      <row>
        <type>main</type>
        <milestone-description>b. Write and submit protocol for concept that studies comparing the neurotoxicology of amphetamine with methamphetamine and methylphenidate</milestone-description>
        <milestone-date>7/31/2010</milestone-date>
        <milestone-status>Completed</milestone-status>
        <milestone-completion-date>6/14/2010</milestone-completion-date>
      </row>
      <row>
        <type>main</type>
        <milestone-description>c. Complete evaluation and development of standard operating procedure on specialized testing equipment</milestone-description>
        <milestone-date>6/1/2011</milestone-date>
        <milestone-status>Completed</milestone-status>
        <milestone-completion-date>6/1/2011</milestone-completion-date>
      </row>
      <row>
        <type>main</type>
        <milestone-description>d. Complete initial research on the effects on body temperature and blood pressure in animals exposed to amphetamine or methamphetamine</milestone-description>
        <milestone-date>11/30/2011</milestone-date>
        <milestone-status>Completed</milestone-status>
        <milestone-completion-date>Canceled</milestone-completion-date>
      </row>
      <row>
        <type>main</type>
        <milestone-description>e. Complete assessment/interpretation of research findings</milestone-description>
        <milestone-date>12/1/2012</milestone-date>
        <milestone-status>Completed</milestone-status>
        <milestone-completion-date>Canceled</milestone-completion-date>
      </row>
      <row>
        <type>main</type>
        <milestone-description>f. Develop draft technical report/manuscript/publication on the effects on body temperature and blood pressure in laboratory animals exposed to amphetamine or methamphetamine</milestone-description>
        <milestone-date>4/15/2013</milestone-date>
        <milestone-status>Completed</milestone-status>
        <milestone-completion-date>Canceled</milestone-completion-date>
      </row>
      <row>
        <type>main</type>
        <milestone-description>g. Complete the peer review (NCTR and other FDA researchers) of draft technical report, manuscript, and/or publication</milestone-description>
        <milestone-date>6/15/2013</milestone-date>
        <milestone-status>Completed</milestone-status>
        <milestone-completion-date>Canceled</milestone-completion-date>
      </row>
      <row>
        <type>main</type>
        <milestone-description>h. Submit final technical report, manuscript, and/or publication on the effects on body temperature and blood pressure in animals exposed to amphetamine or methamphetamine</milestone-description>
        <milestone-date>10/15/2013</milestone-date>
        <milestone-status>Completed</milestone-status>
        <milestone-completion-date>Canceled</milestone-completion-date>
      </row>
      <footnotes>
        <note></note>
      </footnotes>
    </table>
  </projects>
  <glossary>
    <word>
      <text>CNS</text>
      <definition>Central Nervous System</definition>
    </word>
    <word>
      <text>CDER</text>
      <definition>Center for Drug Evaluation and Research</definition>
    </word>
  </glossary>
  <related-links>
    <link>
      <url>http://www.fda.gov/AboutFDA/Transparency/track/ucm203296.htm</url>
      <text>FDA-TRACK NCTR Dashboard</text>
    </link>
    <link>
      <url>http://www.fda.gov/AboutFDA/Transparency/track/ucm252974.htm</url>
      <text>FDA-TRACK Research Glossary</text>
    </link>
  </related-links>
</key-projects>਍††਍਍਍਍਍਍਍