The Food and Drug Administration (FDA) has announced the rates for biosimilar and prescription drug user fees for FY 2013. By way of background, the Federal Food, Drug, and Cosmetic Act (the FD&C Act) authorizes FDA to assess and collect user fees for certain activities in connection with biosimilar biological product and prescription drug development, for certain applications and supplements for approval of biosimilar biological products, on establishments where approved biosimilar biological product products are made, and on biosimilar biological products after approval. The FY 2013 rates for both biosimilar and prescription drug fees are as follows: initial and annual fees -- $195,880; reactivation fee -- $391,760; fee for a product application requiring clinical data -- $1,958,800; fee for a product application not requiring clinical data -- $979,400; fee for a product supplement requiring clinical data -- $979,400; product establishment fee -- $526,500; and product fee -- $98,380. These fees are effective on October 1, 2012, and will remain in effect through September 30, 2013.