Background (FY 2010)
The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by ADUFA, authorizes FDA to collect fees from the animal pharmaceutical industry to augment appropriations spent on FDA’s animal drug review process. FDA spends the fee revenues to hire, support, and maintain personnel for the review of animal drug applications to ensure safe and effective drug products reach the American public more quickly.
- fees on certain animal drug applications and supplemental animal drug applications (for which safety or effectiveness data are required);
- annual fees for certain animal drug products;
- annual fees for certain establishments that manufacture animal drug products; and
- annual fees paid by certain animal drug sponsors.
The aggregate fee revenue amount, and amounts for each type of fee, are set in statute, with provisions for adjustment. ADUFA II authorizes FDA to set fees for each fiscal year so that the total revenue FDA receives in each category is estimated to equal the statutory amount, after adjustment for workload—and no adjustment for workload was required when FDA set fees for 2010 in August of 2009. FY 2010 is the seventh year of the ADUFA program. FDA set fees for FY 2010 in accordance with the amounts specified in ADUFA II (see 73 FR 53254). Inflation adjustments were built into the statutory fee revenue totals for each of the five years of ADUFA II, so no additional changes are necessary.