User Fee Collections
AGDUFA specifies that the user fees shall be collected for certain abbreviated applications for generic new animal drugs upon their submission, and annual fees shall be collected for certain products and sponsors. The statute also specifies the amount FDA is allowed to collect for each of these categories, and how the fee rates should be adjusted in each fiscal year for increases in workload.
Under AGDUFA, fees collected and appropriated, but not spent by the end of a fiscal year, continue to remain available for FDA to spend in future fiscal years. The balances carried forward from year to year are described on page 7.
The following table provides a breakout of user fees collected and receivable by fee source in FY 2009.
FOOD AND DRUG ADMINISTRATION
STATEMENT OF GENERIC NEW ANIMAL DRUG USER FEE COLLECTIONS
AND RECEIVABLES BY FEE SOURCES
AS OF SEPTEMBER 30, 2009
Fees Collected FY 2009 Application Fees $909,674 Product Fees $1,832,832 Sponsor Fees $1,845,490 TOTAL COLLECTIONS $4,587,996 Fees Receivable Product Fees $3,198 Sponsor Fees $84,525 TOTAL RECEIVABLES $87,723
User fee collections are reported in the year the fee was originally due—referred to as cohort years. For example, a fee originally due in FY 2009, even if it is received in FY 2010, is attributed to FY 2009 collections. Since FY 2009 was the first year of AGDUFA, no collections received relate to prior cohort years.
The receivables for FY 2009 are from uncollected product and sponsor fees. FDA turns these receivables over to the Program Support Center (PSC) of the Office of the Secretary for collection after some time. PSC, in turn, will assign the accounts to a collection agency under contract to them for collection.
Totals reported for each fiscal year are net of any refunds for that year. In order to ensure the quality of the information provided in financial reports, FDA will update prior year collections and receivables each