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Zdrowie i gospodarka · 1.08.2016

Outsourcing Facility Fee Rates for Fiscal Year 2017

The Food and Drug Administration (FDA) is announcing the fiscal year (FY) 2017 rates for the establishment and re-inspection fees related to entities that compound human drugs and elect to register as outsourcing facilities under the Federal Food, Drug, and Cosmetic Act (the FD&C Act). 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. This document establishes the FY 2017 rates for the small business establishment fee ($5,279), the non-small business establishment fee ($16,852), and the re-inspection fee ($15,837) for outsourcing facilities; provides information on how the fees for FY 2017 were determined; and describes the payment procedures outsourcing facilities should follow. These fee rates are effective October 1, 2016, and will remain in effect through September 30, 2017.

Source: Federal Register — Food and Drug AdministrationOpen original release →