Guideline 170

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Animal Drug User Fees and Fee Waivers and Reductions - Final Guidance

Revised October 1, 2008

U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
FOOD AND DRUG ADMINISTRATION
CENTER FOR VETERINARY MEDICINE

Guidance for Industry

Animal Drug User Fees
and Fee Waivers and Reductions

FINAL GUIDANCE

This version of the guidance replaces that which was made available on March 14, 2004, and September 4, 2008. This guidance document has been revised in response to the Animal Drug User Fees Amendments of 2008 to reflect that now animal drug applications subject to the criteria set forth in section 512(d)(4) of the FD&C Act will only pay a supplemental animal drug application fee rate (50% of the full application fee rate) instead of a full application fee. This final guidance also corrects the contact information in regard to this document. This second revision of the guidance clarifies that the definitions of “minor use” and “minor species” were defined in 21 CFR 516.3(b).

Comments and suggestions regarding this guidance should be sent to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852. All comments should be identified with the Docket No. 2004D-0124. Comments may also be submitted electronically via the Internet at http://www.fda.gov/cvm or at http://www.regulations.gov/.

For questions regarding this document, contact Diane L. Heinz, Center for Veterinary Medicine (HFV-100), Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855, 240-276-8234, e-mail: diane.heinz@fda.hhs.gov.

Additional copies of this final guidance may be requested from the Communications Staff (HFV-12), Center for Veterinary Medicine, Food and Drug Administration, 7519 Standish Place, Rockville, MD 20855 and may be viewed on the Internet http://www.fda.gov/cvm.

Paperwork Reduction Act Public Burden Statement
According to the Paperwork Reduction Act of 1995, a collection of information should display a valid OMB control number. The valid OMB control number for this information collection is 0910-0540. It expires February 28, 2011. The time required to complete this information collection is estimated to average 2 hours per response, including the time to review instructions, search existing data resources, and gather the data needed, and complete and review the information collection.

This guidance represents the Food and Drug Administration’s (FDA’s) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, call the appropriate number listed on the title page of this guidance.