Frequently Asked Questions about AGDUFA
September 24, 2008
Question: Why did Congress authorize fees for the generic animal drug review program?
Congress indicated in passing AGDUFA that animal health and the public health will be served by making additional funds available to FDA’s process for the review of new animal generic drug applications as set forth in CVM’s performance goals for AGDUFA.
Question: What are the types of fees that were authorized in AGDUFA?
AGDUFA establishes three different kinds of user fees:
- fees for certain types of abbreviated applications for generic new animal drugs,
- annual fees for certain generic new animal drug products, and
- annual fees for certain sponsors of generic animal drug applications and/or investigational submissions for a generic new animal drug. Application fees, product fees, and sponsor fees are to generate revenue approximating 30%, 35%, and 35%, respectively, of the total revenues authorized for a given fiscal year.
Question: What is the application fee rate?
On September 15, 2008, the Agency published in the Federal Register a notice establishing fee rates for applications. The application fee rate is $41,400 for an original abbreviated new animal drug application (ANADA). The Federal Register notice contains a very detailed explanation of the fee and the assumptions and methodology used by the Agency in establishing the fee under AGDUFA.
Question: When do I pay a fee for an application that I submitted on or after July 1, 2008?
No fees are to be submitted until appropriations have been made for AGDUFA. However, you will owe a fee for any original abbreviated application for a generic new animal drug that you submitted on or after July 1, 2008 (21 U.S.C. 379j-12(a)(1)(A)). The Food and Drug Administration is unable to collect user fees because Congress has not yet made appropriations for the Animal Generic Drug User Fee Act. FDA states in the Federal Register notice of September 15, 2008, that there will be a subsequent notice once appropriations have been granted and that this notice will provide payment instructions and payment procedures.
Question: Why didn’t Congress just authorize application fees?
The product and sponsor fees will, by design, add stability and predictability to the fee structure; whereas, the number of applications may vary more from year to year. This design is particularly important in ensuring the level of income authorized by Congress, and necessary to achieve the ever increasing performance goals established for the program over 5 years.
Question: What are the waivers/reductions under AGDUFA?
The waivers/reductions under the AGDUFA program is the Minor Use or Minor Species waiver. The waiver for Minor Use or Minor Species is applied when the abbreviated application for a generic new animal drug is intended solely to provide for a minor use or minor species indication.
Question: Why is the sponsor fee tiered into three fee rates?
The sponsor fee is tiered into three fee rates to act as a reduction. The tier structure of the sponsor fee is designed to help accommodate sponsors who are small businesses and lack sufficient funds to pay the fee in full. Each generic new animal drug sponsor shall pay only one such fee each fiscal year, as follows:
- 100 percent of the amount of the generic new animal drug sponsor fee published for that fiscal year for an applicant with more than 6 approved abbreviated applications.
- 75 percent of the amount of the generic new animal drug sponsor fee published for that fiscal year for an applicant with more than 1 and fewer than 7 approved abbreviated applications.
- 50 percent of the amount of the generic new animal drug sponsor fee published for that fiscal year for an applicant with 1 or fewer approved abbreviated applications.
Question: How and when do I apply for a waiver or reduction?
No requests for waivers or reductions are currently being accepted. Waivers and reductions apply to specific fees due for a specific application each calendar year. Request for waivers and reductions must be submitted in writing. FDA encourages submissions of request at least 90 days before the fees are due. There will be a guidance published before appropriations are established which will provide further details and instructions on procedures regarding a waiver or reduction request.