FY2010 Total Cost of the process for the review of Animal Drug Applications
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Table 6 shows the costs for the review of abbreviated applications for generic new animal drugs during the past fiscal year 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 2009 and FY 2010.
Process for the Review of Abbreviated Applications for Generic New Animal Drugs Total Cost
As of September 30, 2010
Center for Veterinary Medicine (CVM)
Field Inspection and Investigation (ORA)
Agency General and Administrative Costs
Total Process Costs
Obligations from Appropriations
Obligations from Generic New Animal Drug User Fees
A time reporting analysis is performed each year using data from FDA’s CVM Activity Time Reporting (ATR) System to determine the percentage of time each organizational component within CVM devoted to activities that are included in the process for the review of abbreviated applications for generic new animal drugs, as defined in AGDUFA. This facilitates the calculation of process costs.
The field inspection and investigation are pre-approval inspections of manufacturing facilities, investigations of clinical studies, and analytical testing of samples that are counted for the review process for abbreviated applications for generic new animal drugs. FDA’s ORA captures time spent in its field inspection and investigation by using the Field Accomplishments and Compliance Tracking System (FACTS).
Agency General and Administrative Costs increased in FY 2010 because the number of user fee funded FTE positions dedicated to the process for the review of animal drug applications went from 9 in AGDUFA’s first year to 21 in FY 2010.
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