<?xml version="1.0" encoding="UTF-8" standalone="no"?>
<key-projects><projects><title>Pilot Program: Sharing “Health Hazard” Class 3 Sample Laboratory Results (HC3SLR) with Foreign Government Competent Authorities (FGCA)</title><description>The objective of this six-month pilot program is to explore the feasibility and set forth a procedure for the LAO to share HC3SLR with the appropriate FGCAs in the Latin America and Caribbean region. The Office of Regulatory Affairs (ORA), Division of Import Operations and Policy (DIOP) will provide OIP’s Office of Global Engagement (OGE) with a standard daily report, using ORDSS data, by email. The ORA report will contain results of FDA Import samples from food and other import compliance programs designated by OIP.  OGE will forward the HC3SLR Report to the LAO Director who will distribute the information to the LAO staff according to the country of interest. The LAO will send the relevant laboratory information to the FGCA. If the final status of the laboratory results is not evident, the LAO will verify the information and details obtained by contacting the FDA district office associated with the laboratory that performed the analysis, and generate a standard letter to deliver to the FGCA. The information may also be delivered by direct telephone communication.  The goal of this pilot is to establish a program that provides a report as early as possible to all OIP foreign offices on violative import samples that originate from their respective countries.</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. Develop “Health Hazard Class 3 Sample Laboratory Results (HC3SLR) Report"</milestone-description><milestone-date>7/18/2011</milestone-date><milestone-status>Completed</milestone-status><milestone-completion-date>7/18/2011</milestone-completion-date></row><row><type></type><milestone-description>B. Develop “Report of Laboratory Results to FGCA”</milestone-description><milestone-date>7/18/2011</milestone-date><milestone-status>Completed</milestone-status><milestone-completion-date>7/18/2011</milestone-completion-date></row><row><type></type><milestone-description>C. Identify appropriate FGCAs for each country under the specific responsibilities of the LAO</milestone-description><milestone-date>7/18/2011</milestone-date><milestone-status>Completed</milestone-status><milestone-completion-date>7/18/2011</milestone-completion-date></row><row><type></type><milestone-description>D. Develop master spreadsheet to track data/information sent: 1) from OGE to LAO; and 2) from LAO (with appropriate technical review and translation) to FGCA</milestone-description><milestone-date>7/18/2011</milestone-date><milestone-status>Completed</milestone-status><milestone-completion-date>7/18/2011</milestone-completion-date></row><row><type></type><milestone-description>E. Provide LAO staff with training to address the procedures with participant offices/staff</milestone-description><milestone-date>8/4/2011</milestone-date><milestone-status>Completed</milestone-status><milestone-completion-date>8/4/2011</milestone-completion-date></row><row><type></type><milestone-description>F. Conduct a monthly verification of the master spreadsheet data to assure that all information is correct and all significant correspondence is captured</milestone-description><milestone-date>10/20/2011 and 11/20/2011</milestone-date><milestone-status>Completed</milestone-status><milestone-completion-date>10/20/2011</milestone-completion-date></row><row><type></type><milestone-description>G. Conduct bi-monthly review, captured in the master spreadsheet of the responses provided by the FGCA</milestone-description><milestone-date>10/20/2011 and 12/20/2011</milestone-date><milestone-status>Completed</milestone-status><milestone-completion-date>10/20/2011</milestone-completion-date></row><row><type></type><milestone-description>H. Conduct an Outcome Analysis/Evaluation of the pilot program utilizing: 1) information captured in the master spreadsheet; and 2) follow-up responses received from ORA-DIOP, OGE, LAO staff and FGCA contacts (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>I. Share Outcome Analysis/Evaluation results with OIP-OGE and ORA-DIOP (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>J. Utilize Outcome Analysis/Evaluation in coordination with ORA DIOP and DFS, and OGE to determine if: 1) refinements to the process are necessary; and 2) expansion of the program to include other OIP foreign offices is appropriate (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>
    






