<?xml version="1.0" encoding="UTF-8" standalone="no"?>
<key-projects><projects><title>Non-Public Information Sharing Program</title><description>Utilize the Agency-wide IT system (AIMS) for tracking and reporting exchanges of non-public information between the FDA and foreign counterparts. Utilizing this system will allow accurate, detailed and timely information exchanges, the ability to monitor and track public health trends as a result of analyzing the type of information that is being requested and shared, and the capability to run detailed reports. For example, by sharing public and non-public information with international regulatory counterparts about recalls in the U.S. of products that have been distributed abroad, FDA advances and expands its consumer protection mission, regardless of where those consumers are located, especially in a globalized economy where supply chains have no borders.</description><dictionary></dictionary><outcome></outcome><accomplishment></accomplishment><free-text>OIP’s key projects are ongoing but will no longer be tracked in FDA-TRACK. Going forward, on a rotating schedule, the Foreign Offices will summarize their efforts related to outreach, technical assistance, capacity-building, relationship-building, etc. during the Quarterly FDA-TRACK Briefing. The notes from their reports will be documented in the Quarterly Briefing Summary on the FDA-TRACK webpage.</free-text><table><title></title><free-text-table></free-text-table><overall-status><briefing>COMPLETED</briefing><prior-briefing>ON TRACK</prior-briefing></overall-status><row><type></type><milestone-description>A. Redesign database</milestone-description><milestone-date>4/30/2010</milestone-date><milestone-status>Completed</milestone-status><milestone-completion-date>5/4/2010</milestone-completion-date></row><row><type></type><milestone-description>B. Create centralized data input system</milestone-description><milestone-date>6/30/2010</milestone-date><milestone-status>Completed</milestone-status><milestone-completion-date>11/8/2010</milestone-completion-date></row><row><type></type><milestone-description>C. System requirements review (make modifications based on Centers' input)</milestone-description><milestone-date>8/30/2010</milestone-date><milestone-status>Completed</milestone-status><milestone-completion-date>8/20/2010</milestone-completion-date></row><row><type></type><milestone-description>D. Usability testing and production readiness review)</milestone-description><milestone-date>9/30/2010</milestone-date><milestone-status>Completed</milestone-status><milestone-completion-date>11/8/2010</milestone-completion-date></row><row><type></type><milestone-description>E. Agency-wide system deployment of the non-public information sharing system and implementation</milestone-description><milestone-date>12/30/2010</milestone-date><milestone-status>Completed</milestone-status><milestone-completion-date>11/8/2010</milestone-completion-date></row><row><type></type><milestone-description>F. Create user accounts for all OIP staff members and provide each user with account information</milestone-description><milestone-date>12/30/2010</milestone-date><milestone-status>Completed</milestone-status><milestone-completion-date>11/9/2010</milestone-completion-date></row><row><type></type><milestone-description>G. Create a SOP and user guide for use of the AIMS system in OIP</milestone-description><milestone-date>4/30/2011</milestone-date><milestone-status>Completed</milestone-status><milestone-completion-date>4/30/2011</milestone-completion-date></row><row><type></type><milestone-description>H. Roll out the new system to all OIP staff members, including training</milestone-description><milestone-date>5/1/2011</milestone-date><milestone-status>Completed</milestone-status><milestone-completion-date>5/18/2011</milestone-completion-date></row><row><type></type><milestone-description>I. Select a detailee to input, monitor and track all requests in the AIMS database</milestone-description><milestone-date>9/15/2011</milestone-date><milestone-status>Completed</milestone-status><milestone-completion-date>9/15/2011</milestone-completion-date></row><row><type></type><milestone-description>J. Hire an FTE to input, monitor and track all requests in the AIMS database (1)</milestone-description><milestone-date>N/A</milestone-date><milestone-status>N/A</milestone-status><milestone-completion-date>N/A</milestone-completion-date></row><row><type></type><milestone-description>K. Reassess system and provide first annual report (1)</milestone-description><milestone-date>N/A</milestone-date><milestone-status>N/A</milestone-status><milestone-completion-date>N/A</milestone-completion-date></row><row><type></type><milestone-description>L. Consider and implement enhancements based upon a reassessment of the system and user input during the first year (1)</milestone-description><milestone-date>N/A</milestone-date><milestone-status>N/A</milestone-status><milestone-completion-date>N/A</milestone-completion-date></row><footnotes><note>(1) Milestones were not completed while this project was tracked in FDA-TRACK.</note></footnotes></table></projects><glossary><word><text></text><definition></definition></word></glossary><related-links><link><url>http://www.fda.gov/AboutFDA/Transparency/track/ucm206185.htm</url><text>FDA-TRACK Office of International Programs Dashboard</text></link></related-links></key-projects>
    






