Federal Register Notice: FDA is announcing the fee rates for using a tropical disease priority review voucher for fiscal year 2016. The FD&C Act authorizes FDA to determine and collect priority review user fees for certain applications for approval of drug or biological products when those applications use a tropical disease priority review voucher awarded by the secretary of HHS. These vouchers are awarded to the sponsors of certain tropical disease product applications, submitted after September 27, 2007, upon FDA approval of such applications. For an application submitted with a tropical disease priority review voucher in addition to the normal PDUFA fee, the fee rate is $2,727,000. To view this notice, click here.