The U.S. Food and Drug Administration (FDA) recently published its Animal Generic Drug User Fee Rates and Payment Procedures for Fiscal Year 2013. The FDA is authorized under the Animal Generic Drug User Fee Act of 2008 (AGDUFA) to collect user fees for (1) certain types of abbreviated applications for generic new animal drugs, (2) annual fees for certain generic new animal drug products and (3) annual fees for certain sponsors of such applications and/or investigational submissions for generic new animal drugs. The AGDUFA specifies that the aggregate revenue for Fiscal Year 2013 from category (1) is $1,809,000 and from categories (2) and (3) is $2,111,000 each. The FDA found that no adjustments to these values were necessary.
For category (1), the FDA has estimated that the number of applications that will pay fees in Fiscal Year 2013 will be 15 percent lower than the past five years and that the number of reactivated submissions of abbreviated applications for generic new animal drugs will be reduced by 90 percent. Moreover, based on data on the products that have been submitted and the estimated number of applications pending after September 1, 2008, the FDA estimates that a total of 324 products will be subject to the annual products fee for category (2). With respect to category (3), firms required to pay sponsorship fees fall into the following three subcategories: (a) applicants with more than six approved abbreviated applications will pay 100 percent of the sponsor fee; (b) applicants with two to six approved abbreviated applications will pay 75 percent of the sponsor fee; and (c) applicants with one or fewer approved abbreviated applications will pay 50 percent of the sponsor fee. Based on the FDA's data from the last three years, the FDA estimates that for Fiscal Year 2013, 11 sponsors will fall into category (a); 13 sponsors will fall into category (b); and 33 sponsors will fall into category (c). Based on these estimates, the FDA has established the following fee rates for Fiscal Year 2013:
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The FDA has also provided specific procedures for paying these fees.