<?xml version="1.0" encoding="UTF-8" standalone="no"?>
<key-projects><projects><title>Quality Assurance Program (Phase II)</title><description>Continue to strengthen the Quality Assurance Program by developing standard operating procedures for critical processes and establishing a strategic plan.</description><description></description><dictionary></dictionary><outcome>Continued improvement in the Quality Assurance Program will increase the efficiency and consistency of application reviews.</outcome><accomplishment>The second year of a formal OBRR Quality Assurance (QA) Program has proven to be a tremendous asset to the Office.  The QA Staff continued to develop standard operating procedures (SOPs) to streamline, consolidate, and standardize business processes/operations within OBRR which has culminated in the drafting and implementation of twenty-five SOPs this year.  Focusing on our customers, several internal metrics were implemented this fiscal year to monitor mission critical areas which directly relate to improving customer satisfaction.  An ambitious QA Program Strategic Plan for FY 2012-2016 was formulated which continues to focus on improving the efficiency of the Office’s operations and customer satisfaction.  </accomplishment><free-text></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. Finalize priority OBRR Quality Assurance Program procedures</milestone-description><milestone-date>2/28/2011</milestone-date><milestone-status>Completed</milestone-status><milestone-completion-date>1/20/2011</milestone-completion-date></row><row><type></type><milestone-description>B. Attain senior management approval to implement the priority OBRR Quality Assurance Program procedures</milestone-description><milestone-date>4/30/2011</milestone-date><milestone-status>Completed</milestone-status><milestone-completion-date>4/8/2011</milestone-completion-date></row><row><type></type><milestone-description>C. Complete staff training on the OBRR On-boarding of New Employees Standard Operating Procedures (SOPs)</milestone-description><milestone-date>6/30/2011</milestone-date><milestone-date>&lt;i&gt;(7/31/2011)&lt;i&gt;</milestone-date><milestone-status>Completed</milestone-status><milestone-completion-date>7/29/2011</milestone-completion-date></row><row><type></type><milestone-description>D. Complete staff training on the OBRR Regulatory meetings with Sponsors and Applicants SOP</milestone-description><milestone-date>7/31/2011</milestone-date><milestone-status>Completed</milestone-status><milestone-completion-date>7/29/2011</milestone-completion-date></row><row><type></type><milestone-description>E. Complete staff training on the priority OBRR Quality Assurance Program procedures</milestone-description><milestone-date>10/31/2011</milestone-date><milestone-status>Completed</milestone-status><milestone-completion-date>10/31/2011</milestone-completion-date></row><row><type></type><milestone-description>F. Develop a Strategic Plan for the OBRR Quality Assurance Program</milestone-description><milestone-date>11/30/2011</milestone-date><milestone-status>Completed</milestone-status><milestone-completion-date>11/29/2011</milestone-completion-date></row><row><type></type><milestone-description>G. Communicate the OBRR Quality Assurance Program Strategic Plan to the Staff</milestone-description><milestone-date>12/31/2011</milestone-date><milestone-status>Completed</milestone-status><milestone-completion-date>12/30/2011</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/ucm206349.htm</url><text>FDA-TRACK CBER Research and Review Offices Dashboard</text></link></related-links></key-projects>
    






