<?xml version="1.0" encoding="utf-8" standalone="no"?>
<key-projects>
  <projects>
    <title>Expansion of the Scope of Accredited CBER Test Methods</title>
    <description>This project continues the process of obtaining third party accreditation to ISO/IEC 17025 of test methodologies. External accreditation of CBER’s test methods provides additional transparency and further assurance that CBER tested biological products are safe, pure, and potent. &lt;i&gt;Information is current as of September 30, 2012&lt;/i&gt;.</description>
    <dictionary></dictionary>
    <outcome></outcome>
    <accomplishment>The project’s goal was to have an additional six test methods readied for potential accreditation.  CBER in fact readied ten additional test methods for accreditation, and those methods were audited by the American Association of Laboratory Accreditation in August 2012.  CBER responded to the audit findings in November 2012.  In January 2013, CBER was notified that all ten additional test methods had been accredited to the ISO/IEC 17025 standard. </accomplishment>
    <free-text></free-text>
    <table>
      <title></title>
      <free-text-table></free-text-table>
      <row>
        <type></type>
        <milestone-description>A. Complete method development</milestone-description>
        <milestone-date>1/27/2012</milestone-date>
        <milestone-status>Completed</milestone-status>
        <milestone-completion-date>1/26/2012</milestone-completion-date>
      </row>
      <row>
        <type></type>
        <milestone-description>B. Approve test method documents</milestone-description>
        <milestone-date>3/2/2012</milestone-date>
        <milestone-status>Completed</milestone-status>
        <milestone-completion-date>3/5/2012</milestone-completion-date>
      </row>
      <row>
        <type></type>
        <milestone-description>C. Complete validation and implement method in Lot Release testing</milestone-description>
        <milestone-date>4/20/2012</milestone-date>
        <milestone-status>Completed</milestone-status>
        <milestone-completion-date>4/20/2012</milestone-completion-date>
      </row>
      <row>
        <type></type>
        <milestone-description>D. Third party audit</milestone-description>
        <milestone-date>8/31/2012</milestone-date>
        <milestone-status>Completed</milestone-status>
        <milestone-completion-date>8/31/2012</milestone-completion-date>
      </row>
      <row>
        <type></type>
        <milestone-description>E. Respond to audit findings</milestone-description>
        <milestone-date>11/30/2012</milestone-date>
        <milestone-status>Completed</milestone-status>
        <milestone-completion-date>11/9/2012</milestone-completion-date>
      </row>
      <footnotes>
        <note></note>
      </footnotes>
    </table>
  </projects>
  <glossary>
    <word>
      <text>Molecular Epidemiology</text>
      <definition>Molecular epidemiology is a branch of medical science that focuses on the contribution of potential genetic and environmental risk factors, identified at the molecular level, to the etiology, distribution and prevention of disease within families and across populations.</definition>
    </word>
  </glossary>
  <related-links>
    <link>
      <url>http://www.fda.gov/AboutFDA/Transparency/track/ucm206350.htm</url>
      <text>FDA-TRACK CBER Cross Program Support Offices Dashboard</text>
    </link>
  </related-links>
</key-projects>਍††਍਍਍਍਍਍਍