<?xml version="1.0" encoding="utf-8" standalone="no"?>
<key-projects>
  <projects>
    <title>Stress and Mitochondrial Toxicity</title>
    <description>Exploring mechanisms of free radical damage and toxicity to mitochondria as they relate to neurotoxicity/neurodegeneration.  This study is supported by an interagency agreement between NIEHS/NTP and FDA to support studies of mutual benefit to FDA and NIEHS/ NIH.</description>
    <dictionary>Oxidative stress is caused by an imbalance in cells between reactive oxygen and their ability to detoxify reactive oxygen. This ability is related to aging and to several diseases. Mitochondrial toxicity occurs when the mitochondria of the body's cells become damaged or decline significantly in number. These conditions are studied here in relationship to neurotoxicity and neurodegeneration, both of which can cause loss of cognitive function.</dictionary>
    <dictionary>These studies will provide insight into potential strategies for preventing or ameliorating the progression of neurodegenerative diseases.</dictionary>
    <outcome>These studies will provide insight into potential strategies for preventing or alleviating the progression of neurodegenerative diseases which cause the progressive loss of structure or function of neurons.</outcome>
    <accomplishment></accomplishment>
    <table>
      <title>1. Cell Phone Radiation Neurotoxicity</title>
      <overall-status>
        <briefing>ON TRACK</briefing>
        <prior-briefing>ON TRACK</prior-briefing>
      </overall-status>
      <row>
        <type></type>
        <milestone-description>a. Submit protocol to assess neurotoxicity associated with cell phone radiation</milestone-description>
        <milestone-date>10/31/2009</milestone-date>
        <milestone-status>Completed</milestone-status>
        <milestone-completion-date>12/31/2009</milestone-completion-date>
      </row>
      <row>
        <type></type>
        <milestone-description>b. Start recruiting ORISE postdoc for cell phone radiation study</milestone-description>
        <milestone-date>1/31/2010</milestone-date>
        <milestone-status>Completed</milestone-status>
        <milestone-completion-date>1/20/2010</milestone-completion-date>
      </row>
      <row>
        <type></type>
        <milestone-description>c. Onboard ORISE postdoc and begin work on cell phone radiation study</milestone-description>
        <milestone-date>4/30/2010</milestone-date>
        <milestone-status>Completed</milestone-status>
        <milestone-completion-date>3/15/2010</milestone-completion-date>
      </row>
      <row>
        <type></type>
        <milestone-description>d. Present results at TSSRC</milestone-description>
        <milestone-date>5/31/2010</milestone-date>
        <milestone-status>Completed</milestone-status>
        <milestone-completion-date>5/18/2010</milestone-completion-date>
      </row>
      <row>
        <type>main</type>
        <milestone-description>e. Generate data from cell phone radiation protocol in preparation for Toxicology Study Selection Review Meeting</milestone-description>
        <milestone-date>9/30/2010</milestone-date>
        <milestone-date>&lt;i&gt;(12/31/2010)&lt;/i&gt;</milestone-date>
        <milestone-status>Completed</milestone-status>
        <milestone-completion-date>11/17/2010</milestone-completion-date>
      </row>
      <row>
        <type>main</type>
        <milestone-description>f. Complete assessment of research findings</milestone-description>
        <milestone-date>5/30/2011</milestone-date>
        <milestone-status>Completed</milestone-status>
        <milestone-completion-date>5/30/2011</milestone-completion-date>
      </row>
      <row>
        <type>main</type>
        <milestone-description>g. Develop draft technical report/manuscript/publication on the effects on neurotoxicity association with cell phone radiation</milestone-description>
        <milestone-date>6/30/2011</milestone-date>
        <milestone-status>Completed</milestone-status>
        <milestone-completion-date>6/30/2011</milestone-completion-date>
      </row>
      <row>
        <type>main</type>
        <milestone-description>h. Complete the peer review (NCTR and other FDA researchers) of draft technical report, manuscript, and/or publication</milestone-description>
        <milestone-date>8/31/2011</milestone-date>
        <milestone-date>&lt;i&gt;(TBD)&lt;/i&gt;</milestone-date>
        <milestone-status>Completed</milestone-status>
        <milestone-completion-date>12/31/2012</milestone-completion-date>
      </row>
      <row>
        <type>main</type>
        <milestone-description>i. Obtain NCTR Center Director approval on the draft technical report, manuscript, and/or publication via the document tracking system</milestone-description>
        <milestone-date>9/30/2011</milestone-date>
        <milestone-date>&lt;i&gt;(3/15/2012)&lt;/i&gt;</milestone-date>
        <milestone-date>&lt;i&gt;(FY13 Q1)&lt;/i&gt;</milestone-date>
        <milestone-status>On Track</milestone-status>
        <milestone-completion-date></milestone-completion-date>
      </row>
      <row>
        <type>main</type>
        <milestone-description>j. Submit final technical report, manuscript, and/or publication on neurotoxicity association with cell phone radiation to a scientific journal/NTP</milestone-description>
        <milestone-date>11/1/2011</milestone-date>
        <milestone-date>&lt;i&gt;(4/15/2012)&lt;/i&gt;</milestone-date>
        <milestone-date>&lt;i&gt;(FY13 Q1)&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. Oxidative Stress Projects</title>
      <free-text-table>&lt;b&gt;Accomplishment:&lt;/b&gt;Major findings from this research identified possible neuroprotective roles for carnitine compounds for 3-NPA-induced hypothermia and neuronal degeneration and resveratrol for 3-NPA evoked peripheral neuropathy.</free-text-table>
      <row>
        <type>main</type>
        <milestone-description>a. Submit concept paper on oxidative stress, neurodegeneration and imaging biomarkers</milestone-description>
        <milestone-date>11/30/2009</milestone-date>
        <milestone-status>Completed</milestone-status>
        <milestone-completion-date>3/3/2010</milestone-completion-date>
      </row>
      <row>
        <type>main</type>
        <milestone-description>b. Submit concept paper on oxidative stress, nanoparticles and MRI</milestone-description>
        <milestone-date>2/28/2010</milestone-date>
        <milestone-status>Completed</milestone-status>
        <milestone-completion-date>3/15/2010</milestone-completion-date>
      </row>
      <row>
        <type>main</type>
        <milestone-description>c. Submit manuscript on oxidative stress, nanoparticles, and MRI</milestone-description>
        <milestone-date>6/30/2010</milestone-date>
        <milestone-status>Completed</milestone-status>
        <milestone-completion-date>6/15/2010</milestone-completion-date>
      </row>
      <row>
        <type>main</type>
        <milestone-description>d. Submit additional manuscript on oxidative stress, nanoparticles, and blood brain barrier to a scientific journal</milestone-description>
        <milestone-date>7/31/2010</milestone-date>
        <milestone-status>Completed</milestone-status>
        <milestone-completion-date>8/25/2010</milestone-completion-date>
      </row>
      <footnotes>
        <note></note>
      </footnotes>
    </table>
    <table>
      <title>3. Silver Nanoparticles Study</title>
      <overall-status>
        <briefing>ON TRACK</briefing>
        <prior-briefing>ON TRACK</prior-briefing>
      </overall-status>
      <row>
        <type>main</type>
        <milestone-description>a. Receive and install microscope for cell culture lab</milestone-description>
        <milestone-date>12/31/2009</milestone-date>
        <milestone-status>Completed</milestone-status>
        <milestone-completion-date>12/14/2009</milestone-completion-date>
      </row>
      <row>
        <type>main</type>
        <milestone-description>b. Begin use of the confocal microscope in support of silver nanoparticles study</milestone-description>
        <milestone-date>3/31/2010</milestone-date>
        <milestone-status>Completed</milestone-status>
        <milestone-completion-date>3/8/2010</milestone-completion-date>
      </row>
      <row>
        <type>main</type>
        <milestone-description>c. Review results obtained using the confocal microscope in support of silver nanoparticles study</milestone-description>
        <milestone-date>6/30/2010</milestone-date>
        <milestone-date>&lt;i&gt;(8/30/2010)&lt;/i&gt;</milestone-date>
        <milestone-date>&lt;i&gt;(12/1/2010)&lt;/i&gt;</milestone-date>
        <milestone-date>&lt;i&gt;(2/28/2011)&lt;/i&gt;</milestone-date>
        <milestone-status>Completed</milestone-status>
        <milestone-completion-date>2/28/2011</milestone-completion-date>
      </row>
      <row>
        <type>main</type>
        <milestone-description>d. Complete assessment research findings</milestone-description>
        <milestone-date>12/31/2010</milestone-date>
        <milestone-date>&lt;i&gt;(2/28/2011)&lt;/i&gt;</milestone-date>
        <milestone-status>Completed</milestone-status>
        <milestone-completion-date>2/28/2011</milestone-completion-date>
      </row>
      <row>
        <type>main</type>
        <milestone-description>e. Submit abstract on findings to Scientific meeting</milestone-description>
        <milestone-date>12/31/2010</milestone-date>
        <milestone-date>&lt;i&gt;(2/28/2011)&lt;/i&gt;</milestone-date>
        <milestone-status>Completed</milestone-status>
        <milestone-completion-date>3/23/2011</milestone-completion-date>
      </row>
      <row>
        <type>main</type>
        <milestone-description>f. Develop draft technical report/manuscript/publication on the silver nanoparticles study results</milestone-description>
        <milestone-date>2/1/2011</milestone-date>
        <milestone-status>Completed</milestone-status>
        <milestone-completion-date>3/1/2011</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>4/1/2011</milestone-date>
        <milestone-status>Completed</milestone-status>
        <milestone-completion-date>4/1/2011</milestone-completion-date>
      </row>
      <row>
        <type>main</type>
        <milestone-description>h. Obtain NCTR Center Director approval on the draft technical report, manuscript, and/or publication via the document tracking system</milestone-description>
        <milestone-date>5/1/2011</milestone-date>
        <milestone-status>Completed</milestone-status>
        <milestone-completion-date>5/1/2011</milestone-completion-date>
      </row>
      <row>
        <type>main</type>
        <milestone-description>i. Submit final technical report, manuscript, and/or publication on the silver nanoparticles study results to a scientific journal/NTP</milestone-description>
        <milestone-date>7/1/2011</milestone-date>
        <milestone-status>Completed</milestone-status>
        <milestone-completion-date>8/15/2011</milestone-completion-date>
      </row>
      <row>
        <type>main</type>
        <milestone-description>j. Submit additional manuscript on the research results of this Silver Nanoparticles Study to a scientific journal.</milestone-description>
        <milestone-date>3/1/2012</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>
  </projects>
  <glossary>
    <word>
      <text>mitochondria</text>
      <definition>cellular energy sources</definition>
    </word>
    <word>
      <text>NIEHS</text>
      <definition>National Institute of Environmental Health Sciences</definition>
    </word>
    <word>
      <text>NTP</text>
      <definition>National Toxicology Program</definition>
    </word>
    <word>
      <text>NIH</text>
      <definition>National Institutes for Health</definition>
    </word>
    <word>
      <text>carnitine compounds</text>
      <definition>present in muscle and liver and involved in the transport of fatty acids across mitochondrial membranes</definition>
    </word>
    <word>
      <text>neuronal degeneration</text>
      <definition>progressive loss of structure or function of neurons</definition>
    </word>
    <word>
      <text>resveratrol</text>
      <definition>a natural compound found in grapes, mulberries, peanuts, and other plants or food products, especially red wine, that may protect against cancer and cardiovascular disease by acting as an antioxidant, antimutagen, and anti-inflammatory</definition>
    </word>
    <word>
      <text>neuropathy</text>
      <definition>nerve damage</definition>
    </word>
    <word>
      <text>ORISE</text>
      <definition>Oak Ridge Institute for Science and Education</definition>
    </word>
    <word>
      <text>TSSRC</text>
      <definition>Toxicology Study Selection Review Committee</definition>
    </word>
    <word>
      <text>concept paper</text>
      <definition>description of a planned research activity that is submitted to the NCTR Director in advance of submission of a protocol</definition>
    </word>
    <word>
      <text>biomarkers</text>
      <definition>measurable characteristics that indicate the transition between biological states such as healthy or diseased</definition>
    </word>
    <word>
      <text>MRI</text>
      <definition>Magnetic Resonance Imaging</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>਍††਍਍਍਍਍਍਍