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<key-projects>
  <projects>
    <title>Toxicology Studies and Research</title>
    <description>Conduct various studies and research on chemical toxicity levels and issue reports/findings to support risk assessment decisions.  These studies are supported by an interagency agreement between NIEHS/NTP and FDA to support studies of mutual benefit to FDA and NIEHS/NIH.</description>
    <dictionary>These studies will produce scientific publications and reports on the toxicity of materials regulated by the FDA. The information will be shared with FDA Centers and stakeholders to support risk assessment decisions.</dictionary>
    <dictionary>The studies conducted under the Interagency Agreement with the NTP fill data gaps in our understanding of the toxicity of chemicals. In addition, the Nanotechnology Core Facility will enable toxicity studies to be conducted on nanoscale materials, providing the FDA and other stakeholders with an understanding of the principles of toxicity of these materials.</dictionary>
    <outcome>These chemical toxicity level studies and research will help FDA to deepen its understanding in areas such as glucosamine toxicity, AIDS therapeutic toxicity (identify long-term toxicity outcomes using animal models), zinc oxide toxicity, etc. when evaluating the risks of FDA-regulated products.</outcome>
    <accomplishment></accomplishment>
    <table>
      <title>1. AIDS Therapeutics NTP Studies (1)</title>
      <free-text-table>&lt;b&gt;Accomplishment:&lt;/b&gt;The AIDS Therapeutics Technical Report was presented to the NTP Technical Report Review Committee on April 5, 2011. In practice, AIDS therapeutic agents are increasingly administered to HIV-positive pregnant women with little information on the long-term consequences to noninfected offspring. In this study, rodents in gestation were exposed to drugs used to treat HIV (AZT, 3TC, NVP and NFV) in various combinations. Carcinogenic activity was observed with numerous combinations, with the exception of the AZT, 3TC, and NFV combination that had no carcinogenic activity.</free-text-table>
      <row>
        <type>main</type>
        <milestone-description>a. Conduct studies on AIDS Therapeutics</milestone-description>
        <milestone-date>6/1/2008</milestone-date>
        <milestone-status>Completed</milestone-status>
        <milestone-completion-date>6/1/2008</milestone-completion-date>
      </row>
      <row>
        <type>main</type>
        <milestone-description>b. Complete studies on AIDS Therapeutics</milestone-description>
        <milestone-date>9/1/2009</milestone-date>
        <milestone-status>Completed</milestone-status>
        <milestone-completion-date>9/1/2009</milestone-completion-date>
      </row>
      <row>
        <type>main</type>
        <milestone-description>c. Complete NCTR Toxicity of AIDS Therapeutics Final Report</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. Submit NCTR Toxicity of AIDS Therapeutics Final Report to NTP</milestone-description>
        <milestone-date>4/1/2011</milestone-date>
        <milestone-status>Completed</milestone-status>
        <milestone-completion-date>3/1/2011</milestone-completion-date>
      </row>
      <footnotes>
        <note>(1) NTP is an intra-Agency program between NIH and NCTR whereby NIH directs the toxicological research and NCTR performs the research.</note>
      </footnotes>
    </table>
    <table>
      <title>2. Usnea Lichen - Usnic Acid Toxicity NTP Studies</title>
      <overall-status></overall-status>
      <free-text-table>&lt;b&gt;Accomplishment:&lt;/b&gt;TBD</free-text-table>
      <row>
        <type>main</type>
        <milestone-description>a. Conduct studies on Usnea Lichen - Usnic Acid</milestone-description>
        <milestone-date>6/1/2009</milestone-date>
        <milestone-status>Completed</milestone-status>
        <milestone-completion-date>6/1/2009</milestone-completion-date>
      </row>
      <row>
        <type>main</type>
        <milestone-description>b. Complete studies on Usnea Lichen - Usnic Acid</milestone-description>
        <milestone-date>3/15/2011</milestone-date>
        <milestone-status>Completed</milestone-status>
        <milestone-completion-date>3/15/2011</milestone-completion-date>
      </row>
      <row>
        <type>main</type>
        <milestone-description>c. Complete NCTR Toxicity of Usnea Lichen - Usnic Acid Final Report</milestone-description>
        <milestone-date>5/1/2011</milestone-date>
        <milestone-date>&lt;i&gt;(10/1/2011)&lt;/i&gt;</milestone-date>
        <milestone-status>Completed</milestone-status>
        <milestone-completion-date>2/1/2012</milestone-completion-date>
      </row>
      <footnotes>
        <note></note>
      </footnotes>
    </table>
    <table>
      <title>3. Glucosamine - Chondroitin Sulfate Toxicity NTP Study</title>
      <overall-status>
        <free-text-table>&lt;b&gt;Accomplishment:&lt;/b&gt;TBD</free-text-table>
      </overall-status>
      <row>
        <type>main</type>
        <milestone-description>a. Conduct studies on Glucosamine - Chondroitin Sulfate</milestone-description>
        <milestone-date>6/1/2010</milestone-date>
        <milestone-status>Completed</milestone-status>
        <milestone-completion-date>6/1/2010</milestone-completion-date>
      </row>
      <row>
        <type>main</type>
        <milestone-description>b. Complete studies on Glucosamine - Chondroitin Sulfate</milestone-description>
        <milestone-date>1/15/2011</milestone-date>
        <milestone-status>Completed</milestone-status>
        <milestone-completion-date>1/15/2011</milestone-completion-date>
      </row>
      <row>
        <type>main</type>
        <milestone-description>c. Complete NCTR Toxicity of Glucosamine - Chondroitin Sulfate Final Report</milestone-description>
        <milestone-date>7/1/2011</milestone-date>
        <milestone-date>&lt;i&gt;(11/1/2011)&lt;/i&gt;</milestone-date>
        <milestone-date>&lt;i&gt;(1/1/2012)&lt;i&gt;</milestone-date>
        <milestone-status>Completed</milestone-status>
        <milestone-completion-date>6/1/2012</milestone-completion-date>
      </row>
      <footnotes>
        <note></note>
      </footnotes>
    </table>
  </projects>
  <glossary>
    <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 of Health</definition>
    </word>
    <word>
      <text>glucosamine</text>
      <definition>one of the most common non-vitamin, non-mineral, dietary supplements</definition>
    </word>
    <word>
      <text>Usnea Lichen - Usnic Acid</text>
      <definition>herb that is used in home remedy</definition>
    </word>
    <word>
      <text>Glucosamine - Chondroitin Sulfate</text>
      <definition>dietary supplements found naturally in the body that stimulate the formation and repair of articular cartilage and prevent other body enzymes from degrading the building blocks of joint cartilage</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>਍††਍਍਍਍਍਍਍