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U.S. Department of Health and Human Services

About FDA

Pioneer and Generic Animal Drug User Fees Renegotiations

Description: Provide proposal package to Congress outlining the recommendations for reauthorization of the A/GDUFA programs to continue to collect fees for certain animal drug applications, and for the establishments, products and sponsors associated with these and previously approved animal drug applications, in support of the review of pioneer and generic animal drugs. (1)

Briefing Status: COMPLETED

Prior Briefing Status: ON TRACK

Milestone DescriptionMilestone DateMilestone StatusMilestone Completion Date

1. Gather feedback on suggestions regarding reauthorization including specific suggestions for changes to the A/GDUFA goals, hold a public meeting and open a docket to gather written comments

11/7/2011

Completed 11/7/2011

2. Analyze written comments submitted to the docket to inform stakeholder and industry discussions

12/30/2011

Completed 12/7/2011

3. Conduct periodic consultations with representatives of veterinary, patient, and consumer advocacy groups to continue discussions of their views on reauthorization and their suggestions for changes

5/30/2012

(7/31/2012)

Completed 7/19/2012

4. Conduct negotiations and reach agreement with the regulated industry on user fee program reauthorizations

 

a. ADUFA Program

7/24/2012

Completed 7/24/2012

b. AGDUFA Program

6/30/2012

Completed 4/19/2012

5. Submit draft package of proposal recommendations for reauthorizations for administration review and clearance

8/1/2012

(10/15/2012)

Completed 9/13/2012

6. Publish draft proposed recommendations in Federal Register and provide 30-day comment period

9/15/2012

(10/19/2012)

Completed 12/5/2012

7. Hold a public meeting to gather feedback on the proposed recommendations for reauthorization

11/1/2012

(11/20/2012)

Completed 12/18/2012

8. Revise recommendations as necessary per public input

12/15/2012

(12/31/2012)

(1/14/2013)

Completed 1/9/2013

9. Transmit final package of prepared recommendations for reauthorization to Congress by January 15, 2013

1/15/2013

Completed 2/25/2013

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

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.