ADUFA Cover Sheet and Guidance Available

March 16, 2004

The Food and Drug Administration (FDA) is announcing the availability of an Animal Drug User Fee Cover Sheet that is needed for each animal drug application or supplement filed under the Animal Drug User Fee Act of 2003 (ADUFA) In addition, FDA is announcing the availability of a guidance document for industry (GFI #170) entitled “Animal Drug User Fees and Fee Waivers and Reductions.” The purpose of this document is to provide guidance to industry on the fee waiver provisions of ADUFA.

The Federal Food, Drug, and Cosmetic Act, as amended by the Animal Drug User Fee Act of 2003 authorizes FDA to collect user fees for certain animal drug applications, on certain animal drug products, on certain establishments where such products are made, and on certain sponsors of such animal drug applications and/or investigational animal drug submissions.

GFI 170 includes a list of the specific provisions under which an animal drug sponsor can request a waiver or a fee reduction. These provisions are when: the fee would constitute a significant barrier to innovation; the fees would exceed the cost; the application is for an animal drug used in a Type B medicated feed intended for use in the manufacture of Type C free-choice feed or in a Type C free-choice medicated feed; the drug would be used solely in a minor species or for a minor use; or when the application comes from a “small business,” which is defined as an entity with fewer than 500 employees, including employees of affiliates, submitting its first animal drug application.

This guidance is posted on the CVM home page. Single copies of the guidance may be obtained by writing to the Communications Staff, FDA/Center for Veterinary Medicine, 7519 Standish Place, HFV-12, Rockville, MD 20855, 301-827-3800. Please send one self-addressed adhesive label to assist in processing your request.

This Level 1 guidance is being issued consistent with FDA's good guidance practices regulations (GGPs). The guidance represents the Agency's current thinking on the fee waiver provisions of ADUFA. It does not create or confer any rights for or on any person and will not operate to bind FDA or the public. Alternative methods may be used as long as they satisfy the requirements of the applicable statutes and regulations.

The guidance document is in effect immediately, but it remains subject to comment in accordance with the Agency's GGPs. Written comments on the guidance document may be submitted to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852. Electronic comments may be submitted. Comments should be identified with the full title of the guidance document and Docket 2004D-0124.

Additional information is available from Dr. David Newkirk, Center for Veterinary Medicine (HFV-100), Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855, 301-827-6967, e-mail: dnewkirk@cvm.fda.gov, and will be included in a notice that will be published the March 18, 2004 Federal Register.