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U.S. Department of Health and Human Services

About FDA

Pilot Program: Sharing “Health Hazard” Class 3 Sample Laboratory Results (HC3SLR) with Foreign Government Competent Authorities (FGCA)

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.

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.

Briefing Status: COMPLETED

Prior Briefing Status: ON TRACK

Milestone DescriptionMilestone DateMilestone StatusMilestone Completion Date

A. Develop “Health Hazard Class 3 Sample Laboratory Results (HC3SLR) Report"

7/18/2011

Completed 7/18/2011

B. Develop “Report of Laboratory Results to FGCA”

7/18/2011

Completed 7/18/2011

C. Identify appropriate FGCAs for each country under the specific responsibilities of the LAO

7/18/2011

Completed 7/18/2011

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

7/18/2011

Completed 7/18/2011

E. Provide LAO staff with training to address the procedures with participant offices/staff

8/4/2011

Completed 8/4/2011

F. Conduct a monthly verification of the master spreadsheet data to assure that all information is correct and all significant correspondence is captured

10/20/2011 and 11/20/2011

Completed 10/20/2011

G. Conduct bi-monthly review, captured in the master spreadsheet of the responses provided by the FGCA

10/20/2011 and 12/20/2011

Completed 10/20/2011

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)

N/A

N/A N/A

I. Share Outcome Analysis/Evaluation results with OIP-OGE and ORA-DIOP (1)

N/A

N/A N/A

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)

N/A

N/A N/A

Footnotes

  • (1) Milestones were not completed while this project was tracked in FDA-TRACK.

Key Projects Legend

Milestone StatusDefinition
Not Yet StartedWork for specific milestone has not yet been started.
CompletedMilestone and/or overall project is completed.
On TrackMilestone - On track for completion by milestone deadline. Quarter status - Project is on track for completion based on overall milestone status.
On HoldMilestone - On hold, but deadline for completion has not passed. Quarter status - Project is on hold, based on overall milestone status.
DelayedMilestone - Delayed as it has not been completed and deadline has passed. Quarter status - Project is delayed based on overall milestone status.

Glossary

Note: The data provided on this website is produced on an ongoing basis for performance management purposes and is subject to change due to updates of preliminary estimates, corrections, or other reasons. In addition, FDA may change the type or amount of data provided on this website at any time. Information marked as "Completed" may include measures and/or key projects for which activities are ongoing but no longer tracked as part of FDA-TRACK.