Total Cost of the Process for the Review of Animal Drug Applications
The table below shows the costs for the review of animal drug applications during the past 2 fiscal years by FDA organizational components. It depicts the full costs 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 2009.
FOOD AND DRUG ADMINISTRATION
PROCESS FOR THE REVIEW OF ANIMAL DRUG APPLICATIONS – TOTAL COST
AS OF SEPTEMBER 30, 2009
|FDA Component||FY 2008||FY 2009|
|Center for Veterinary Medicine (CVM)||$47,924,715||$56,692,025|
|Field Inspection and Investigation (ORA)||$1,910,392||$1,886,441|
|Agency General and Administrative Costs||$3,879,767||$4,664,009|
|Total Process Costs||$53,714,874||$63,242,475|
|Obligations from Appropriations||$40,184,805||$49,863,275|
|Obligations from Animal Drug User Fees||$13,530,069||$13,379,200|
In FY 2009, FDA experienced increased costs in CVM and Agency General and Administrative components of the process to review animal drug applications. ORA costs decreased slightly only because the average cost of salary and benefits per ORA FTE decreased due to the hiring of a significant number of new entry-level field personnel in FY 2009. The overall increase in costs is a result of a large appropriation increase and the progress made by FDA to ensure the enhancement of the animal drug review performance in FY 2009 and beyond.
A time reporting analysis is performed each year using data from 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.
The development of the costs associated with the process for the review of animal drug applications is described in more detail in Appendix E.