Total Cost of the Process for the Review of Animal Drug Applications (FY 2010)
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Table 6 shows the costs for the review of animal drug applications during the past two fiscal years by FDA organizational components. It depicts the full cost of the process for the review of animal drug applications paid from appropriations and user fees. The amounts are based upon obligations recorded at the end of FY 2010.
Process for the Review of Animal Drug Applications – 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 Animal Drug User Fees
Numbers may not add due to rounding to the nearest dollar.
In FY 2010, FDA experienced a 2.3 percent increase in the costs of the process to review animal drug applications.
A time reporting analysis is performed each year using data from the 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 animal drug applications, as defined in ADUFA. 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 animal drug applications. ORA captures time spent in its field inspection and investigation by using the Field Accomplishments and Compliance Tracking System (FACTS).
The development of the costs associated with the process for the review of animal drug applications is described in more detail in Appendix E
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