Mar 21, 2013

S. 622, the Animal Drug and Animal Generic Drug User Fee Reauthorization Act of 2013

As reported by the Senate Committee on Health, Education, Labor, and Pensions on March 20, 2013

S. 622 would authorize the collection and spending of fees by the Food and Drug Administration (FDA) for certain activities to expedite the development and marketing approval of drugs for use in animals. Fees would supplement appropriated funds to cover FDA's costs associated with reviewing certain applications and investigational submissions for brand and generic animal drugs. Such fees could be collected and made available for obligation only to the extent and in the amounts provided in advance in appropriation acts. The legislation would extend through fiscal year 2018, and make several technical changes to, FDA's existing fee programs for brand and generic animal drugs, which expire at the end of fiscal year 2013.