Total Cost of the Process for the Review of Abbreviated Applications for Generic New Animal Drugs
The table below 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 2008 and FY 2009.
FOOD AND DRUG ADMINISTRATION
PROCESS FOR THE REVIEW OF ABBREVIATED APPLICATIONS FOR
GENERIC NEW ANIMAL DRUGS
AS OF SEPTEMBER 30, 2009
FDA Component FY 2008 FY 2009 Center for Veterinary Medicine (CVM) $4,969,831 $8,611,608 Field Inspection and Investigation (ORA) $191,039 $565,977 Agency General and Administrative Costs $363,875 $652,852 Total Process Costs $5,524,745 $9,830,437 Obligations from Appropriations $5,524,745 $7,705,137 Obligations from Generic New Animal Drug User Fees $0 $2,125,300
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.
The amounts spent in FY 2009 increased substantially in all categories due to both a large increase in appropriations in FY 2009, and the availability of AGDUFA user fees revenues for the first time in FY 2009.
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.