As amended by the Prescription Drug User Fee Amendments of 2012, The Federal Food, Drug, and Cosmetic Act (FD&C Act) authorizes FDA to assess and collect fees from sponsors submitting applications for the review of human drug and biological products, the manufacturing facilities, and on the products themselves. In order to account for inflation and meet the needs of the Agency, these rates are adjusted on an annual basis and are effective each fiscal year from October 1 to September 30.
The rates for fiscal year 2016 were recently announced by the FDA, and are as follows:
| Fee Category |
Fee Rates for FY 2016 |
| Applications: | |
| Requiring Clinical Data | $2,374,200 |
| Not Requiring Clinical Data | $1,187,100 |
| Supplements Requiring Clinical Data | $1,187,100 |
| Establishments | $585,200 |
| Products | $114,450 |