FDA Outsourcing Facility User Fee Rates: Fiscal Year 2019
According to a recently released notice from the FDA, “the FD&C Act authorizes FDA to assess and collect an annual establishment fee from outsourcing facilities, as well as a re-inspection fee for each re-inspection of an outsourcing facility.” Fees increased slightly between FY 2018 and FY 2019. These updated fee rates will be effective October 1, 2018 through September 30, 2019.
The new user fee rates are as follows:
|Fee Category||FY 2019 Fee Rates||FY 2018 Fee Rates|
|Qualified Small Business Establishment Fee||$5,461||$5,364|
|Non-Small Business Establishment Fee||$18,375||$17,364|