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U.S. Department of Health and Human Services

About FDA

Updating Obsolete Regulatory Residue Methods Project

Description: Develop and validate better methods for veterinary drug residues. Perform bridging studies between the new and existing regulatory residue methods. This project will provide more rapid and reliable methods to detect unsafe veterinary drug residues in animal-derived food products. The improved methods will enhance regulatory agencies' ability to detect unsafe animal-derived food products. (1)

Briefing Status: ON TRACK

Prior Briefing Status: ON TRACK

Milestone DescriptionMilestone DateMilestone StatusMilestone Completion Date

1. Conduct method validation for:


a. Ceftiofur metabolite (marker residue) in ruminant tissues (with an emphasis on kidney, the target issue)


Completed 5/31/2011

b. Chlortetracycline in ruminant tissues (with an emphasis on kidney, the target issue)


Completed 5/31/2011

c. Tetracycline in ruminant tissues (with an emphasis on kidney, the target issue)



2. Develop research protocol for ceftiofur:


a. Develop draft research protocol


Completed 1/31/2011

b. Complete review and approval of research protocol


Completed 3/15/2011

3. Complete the pilot studies for:


a. Chlortetracycline


Completed 4/29/2011

b. Ceftiofur


Completed 7/31/2011

c. Tetracycline



Completed 12/30/2011

4. Complete the main phases of the bridging studies for:


a. Chlortetracycline


Completed 12/31/2011

b. Ceftiofur




Completed 6/15/2012

c. Tetracycline



Completed 6/15/2012

5. Complete assessment of research findings and reports








On Track

6. Determined the candidate drugs for future bridging studies



Completed 12/3/2012

7. Submit methods paper manuscript for publication


Completed 5/30/2012


  • (1) The dates in italics under the milestone due dates are modified due dates which had to be updated due to real-time delays. The milestone status reflects the modified dates.

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.



antimicrobial agent


antimicrobial agent


antimicrobial agent



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.