Health Law Daily FDA outlines animal drug user fees, available fee waivers
Tuesday, July 25, 2017

FDA outlines animal drug user fees, available fee waivers

By Kayla R. Bryant, J.D.

Animal drug applications, including supplemental applications, are considered incomplete and will not be accepted for FDA filing until all required user fees are paid. Fees are considered to be due even if a request for fee waiver or reduction are pending. A revised FDA guidance outlines the type of fees that can be charged and waivers available for animal drug sponsors (Notice, 82 FR 34534. July 25, 2017).

ADUFA fees. The Animal Drug User Fee Act (ADUFA) (P.L. 108-130) and subsequent program reauthorizations require the FDA to assess and collect user fees from animal drug sponsors named in animal drug applications, including supplement applications and investigational submissions. Other ADUFA fees include an annual product fee for each drug product submitted for listing and an annual establishment fee for each person who (1) owns or operates an animal drug establishment; (2) is named as the applicant for a product submitted for listing; and (3) had a pending animal drug application or supplemental animal drug application after September 1, 2003. Establishments that manufacture both animal and human prescription drug products, applicable user fees for both types of products will be assessed.

Waivers and reductions. Several waivers and reductions may be available to sponsors under section 740(d) of the federal Food, Drugs and Cosmetics Act (FDC Act) (21 U.S.C. §301 et seq.). New requests for waivers and reductions must be submitted in writing and no later than 180 days after the fees are due for each application or fiscal year. Fees are considered to be due even when a request is pending, and a sponsor may pay fees and wait for a refund. Sponsors wishing to minimize the likelihood of needing to wait for a refund are encouraged to submit requests at least 90 days before the fees are due. For application fees, this would be 90 days before the expected submission. Sponsor, product, and establishment fees are generally due on or before January 31 each year, so these requests should be submitted by November 1.

The FDA may grant a waiver or reduction of fees when the agency determines that fee assessment would significantly impede innovation due to limited resources available. A product must be considered innovative for this waiver to apply, such as by representing a medical breakthrough through a novel mechanism of action, formulation, or delivery system, and there must be sufficient information to suggest that the product would likely have the proposed effect.

A fee waiver or reduction is also available when the agency finds that the fees to be paid would exceed the present and future costs anticipated to be incurred by the FDA. A "free choice feed" waiver is available when the application is intended to provide for the use of an animal drug in a Type C free-choice medicated feed, or a type B medicated feed intended for use in the manufacture of a Type C free-choice medicated feed. A fee waiver can be granted for drugs intended for an infrequent indication in a major species (minor use) or use in minor species, or for a small business submitting its first animal drug application.

Comments. The FDA has submitted a proposed collection of information on ADUFA waivers and reductions to the Office of Management and Budget (OMB). Comments should be submitted August 17, 2017.

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