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

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

Guidance for Industry

Animal Drug User Fees
and Fee Waivers and Reductions

FINAL GUIDANCE

This guidance provides industry the procedures that FDA recommends a person to follow to request a fee waiver or reduction.

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.accessdata.fda.gov/scripts/oc/dockets/comments/commentdocket.cfm?AGENCY=FDA.  After bringing up this Internet site, select “2004D-0124 Guidance for Industry Animal Drug User Fees and Fee Waivers and Reductions” and follow the directions

For questions regarding this document, contact 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.

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 Home Page.

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 September 30, 2004.  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.

U.S. Department of Health and Human Services
Food and Drug Administration
Center for Veterinary Medicine (CVM)
March 15, 2004

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.

1. Introduction

2. Payment of Fees Pending a Decision on a Waiver/Reduction Request

3. Types of Fees

4. Types of Fee Waivers and Reductions

5. Procedures and Timing for Requesting Fee Waivers or Reductions

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