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Total Cost of the Process for the Review of Abbreviated Applications for Generic New Animal Drugs: FY 2011 AGDUFA Financial Report

Back to Table of Contents: FY 2011 AGDUFA Financial Report

Table 6 shows the costs for the review of abbreviated applications for generic new animal drugs during the past two fiscal years by FDA organizational components.  It depicts the full costs of the process for the review of abbreviated applications for generic new animal drugs paid from appropriations and user fees.  The amounts are based upon obligations recorded at the end of FY 2010 and FY 2011.

 Table 6
Process for the Review of Abbreviated Applications for
Generic New Animal Drugs -Total Cost
as of September 30, 2010 and 2011

 FDA COMPONENT FY 2010 FY 2011
 Center for Veterinary Medicine (CVM) $9,846,687 $10,474,643
 Field Inspection and Investigation (ORA) $403,145 $212,936
 Agency General and Administrative Costs $895,277 $817,505
 TOTAL PROCESS COSTS $11,145,109 11,505,084
 Obligations from Appropriations $6,408,309 $6,819,284
 Obligations from Generic New Animal Drug User Fees $4,736,800 $4,685,800

Of the total of $11,505,084 obligated in support of the process for the review of generic animal drug applications as defined in AGDUFA, about 41 percent came from AGDUFA fees and about 59 percent came from appropriations.

The development of the costs associated with the process for the review of abbreviated applications for generic new animal drugs is described in more detail in Appendix E.

 

Next Section: Management Challenges for FY 2012 – FY 2011 AGDUFA Financial Report