• Decrease
  • Normal
  • Increase
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)

5/31/2011

Completed 5/31/2011

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

6/30/2011

Completed 5/31/2011

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

12/31/2011

Completed

2. Develop research protocol for ceftiofur:

 

a. Develop draft research protocol

1/31/2011

Completed 1/31/2011

b. Complete review and approval of research protocol

3/15/2011

Completed 3/15/2011

3. Complete the pilot studies for:

 

a. Chlortetracycline

5/3/2011

Completed 4/29/2011

b. Ceftiofur

7/31/2011

Completed 7/31/2011

c. Tetracycline

10/31/2011

(12/30/2011)

Completed 12/30/2011

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

 

a. Chlortetracycline

12/31/2011

Completed 12/31/2011

b. Ceftiofur

12/31/2011

(3/30/2012)

(5/31/2012)

Completed 6/15/2012

c. Tetracycline

4/30/2012

(7/31/2012)

Completed 6/15/2012

5. Complete assessment of research findings and reports

6/30/2012

(12/30/2012)

(1/31/2013)

(5/30/2013)

(12/31/2013)

(6/30/2014)

On Track

6. Determined the candidate drugs for future bridging studies

6/30/2012

(12/30/2012)

Completed 12/3/2012

7. Submit methods paper manuscript for publication

9/30/2012

Completed 5/30/2012

Footnotes

  • (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.

Glossary

Ceftiofur

antimicrobial agent

Chlortetracycline

antimicrobial agent

Tetracycline

antimicrobial agent

protocol

guidelines

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.