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<key-projects><projects><title>ADE Reports System Project</title><description>Develop capability to receive ADE reports electronically and work with stakeholders to educate and encourage electronic submission of ADE reports. Due to the continuing increase in the number of ADEs submitted annually (approximately 45,000 reports), the subsequent increasing ADE backlog, the growing medical complexity of approved products, and the limits of the current manual entry system, the pharmacovigilance program is unable to appropriately review and evaluate the data to provide real-time surveillance to proactively identify safety signals (e.g., data mining) and respond to hazards that threaten animal and public health. Implementation of electronic data submission is an extremely valuable capability that will allow electronic receipt of ADEs to prepopulate PV Works, the CVM database, helping CVM respond to this challenge. (1)</description><dictionary></dictionary><outcome></outcome><accomplishment></accomplishment><table><title></title><overall-status><briefing>ON TRACK</briefing><prior-briefing>ON TRACK</prior-briefing></overall-status><row><type>main</type><milestone-description>1. Draft FR notice of revised forms for electronic reporting from industry and send to OMB</milestone-description><milestone-date>3/31/2010</milestone-date><milestone-status>Completed</milestone-status><milestone-completion-date>3/10/2010</milestone-completion-date></row><row><type>main</type><milestone-description>2. Ensure CVM Gateway-to-Gateway interface is capable of receiving electronic reports</milestone-description><milestone-date>4/16/2010</milestone-date><milestone-status>Completed</milestone-status><milestone-completion-date>5/24/2010</milestone-completion-date></row><row><type>main</type><milestone-description>3. Create &lt;a href=http://www.fda.gov/AnimalVeterinary/NewsEvents/CVMUpdates/ucm213168.htm target=”_blank”&gt;CVM Update &lt;/a&gt; on FDA website to alert sponsors of electronic reporting capability (especially those who may not use PV Works)</milestone-description><milestone-date>6/1/2010</milestone-date><milestone-status>Completed</milestone-status><milestone-completion-date>5/24/2010</milestone-completion-date></row><row><type>main</type><milestone-description>4. Develop Outreach program encouraging electronic submission of ADE reports by sponsors</milestone-description><milestone-date>7/10/2010</milestone-date><milestone-status>Completed</milestone-status><milestone-completion-date>5/24/2010</milestone-completion-date></row><footnotes><note>(1) Milestones to be completed in FY 2013 are under development.</note></footnotes></table></projects><glossary><word><text>ADE</text><definition>Adverse Drug Event or Experience</definition></word><word><text>FR</text><definition>Federal Register</definition></word><word><text>OMB</text><definition>Office of Management and Budget</definition></word></glossary><related-links><link><url>http://www.fda.gov/AboutFDA/Transparency/track/ucm203425.htm</url><text>FDA-TRACK CVM Dashboard</text></link><link><url>http://www.fda.gov/AnimalVeterinary/SafetyHealth/ProductSafetyInformation/ucm055369.htm</url><text>ADE Reports Program</text></link></related-links></key-projects>਍††਍਍਍਍਍਍਍