Animal Generic Drug User Fee Act (AGDUFA)
Fee Rates:
| User Fee Type | FY 2022 | FY 2021 |
|---|---|---|
| Application Fees - Original | $548,628 | $513,423 |
| Application fee described in section 512(d)(4) | $274,314 | $256,712 |
| Product Fee | $ 17,513 | $ 17,235 |
| Sponsor Fees: 50% 75% 100% |
$117,149 $175,723 $234,297 |
$100,843 $151,265 $201,687 |
AGDUFA, originally signed into law in 2008 and reauthorized in 2013 and 2018, was designed to enhance the performance of the generic new animal drug review process and enable the FDA to more efficiently ensure that generic new animal drug products are safe and effective. AGDUFA III reauthorizes the FDA to collect user fees for certain abbreviated applications for generic new animal drugs, generic new animal drug products, and from certain sponsors of abbreviated applications for generic new animal drugs and/or investigational submissions for generic new animal drugs. AGDUFA III reauthorizes FDA to collect user fees through FY 2023.
What is an abbreviated application fee?
- Each person that submits an abbreviated application for a generic new animal drug shall be subject to an application fee. The term "abbreviated application for a generic new animal drug " means an application for approval of any generic new animal drug submitted under section 512(b)(2).
- An abbreviated application for an animal generic drug subject to the criteria in section 512(d)(4) of the FD&C Act shall be subject to 50 percent of the fee applicable to all other abbreviated applications for a generic new animal drug.
- Application fees are due when the application is submitted.
How do I pay a fee?
Please visit our Payment information and Cover Sheet tab for all the information you will need to pay your application fee.
What are AGDUFA’s annual fees?
AGDUFA has 2 annual fees. Sponsor and Product. These fees are assessed annually. There is no establishment fee under AGDUFA.
What is a Sponsor Fee?
- The generic new animal drug sponsor fee must be paid annually by each person who: (1) Is named as the applicant in an abbreviated application, except for an approved application for which all subject products have been removed from listing under section 510 of the FD&C Act, or has submitted an investigational submission for a generic new animal drug that has not been terminated or otherwise rendered inactive and (2) had an abbreviated application for a generic new animal drug, supplemental abbreviated application for a generic new animal drug, or investigational submission for a generic new animal drug pending at FDA after September 1, 2008.
- A generic new animal drug sponsor is subject to only one such fee each fiscal year. Applicants with more than 6 approved abbreviated applications will pay 100 percent of the sponsor fee; applicants with more than 1 and fewer than 7 approved abbreviated applications will pay 75 percent of the sponsor fee; and applicants with 1 or fewer approved abbreviated applications will pay 50 percent the sponsor fee.
Guidance documents for additional Sponsor fee information:
What is a Product Fee?
- The generic new animal drug product fee must be paid annually by the person named as the applicant in an abbreviated application or supplemental abbreviated application for a generic new animal drug product submitted for listing under section 510 of the FD&C Act, and who had an abbreviated application or supplemental abbreviated application for a generic new animal drug product pending at FDA after September 1, 2008.
- The term "generic new animal drug product" means each specific strength or potency of a particular active ingredient or ingredients in final dosage form marketed by a particular manufacturer or distributor, which is uniquely identified by the labeler code and product code portions of the national drug code, and for which a generic new animal drug or supplemental abbreviated application for a generic new animal drug has been approved.
- Each NDC is assessed 1 product fee.
How do I pay a fee?
Please visit our Payment information and Cover Sheet tab for all the information you will need to pay your annual fees.
When are user fees due?
- Application and supplement fees are due when the application or supplement is submitted.
- Sponsor and product fees are due annually.
- FDA issues Initial invoices for sponsor and product fees for the coming fiscal year in December of each year. A clean-up invoice will be issued in November after the close of that fiscal year. This invoice will bill for anything new that occurred during that year (after October 1st, but prior to September 30th).
What is the Federal government's fiscal year?
The Federal government's fiscal year begins on October 1 and ends on September 30.
For example, fiscal year 2018 begins October 1, 2017, and ends September 30, 2018. Fiscal year 2019 begins October 1, 2018 and ends September 30, 2019.
What are the instructions for the payment of fees?
The appropriate application fee established in the new fee schedule must be paid for an abbreviated new animal drug application subject to fees under AGDUFA III that is submitted on or after October 1, 2018. The payment must be made in U.S. currency by one of the following methods: wire transfer, electronically, check, bank draft, or U.S. postal money order made payable to the Food and Drug Administration. The preferred payment method is online using electronic check (Automated Clearing House (ACH) also known as eCheck) or credit card (Discover, VISA, MasterCard, American Express). Secure electronic payments can be submitted using the User Fees Payment Portal at https://userfees.fda.gov/pay or the Pay.gov payment option is available to you after you submit a coversheet. (Note: only full payments are expected. No partial payments can be made online). Once you search for and find your invoice, select “Pay Now” to be redirected to Pay.gov. Electronic payment options are based on the balance due. Payment by credit card is available only for balances that are less than $25,000. If the balance exceeds this amount, only the ACH option is available. Payments must be made using U.S. bank accounts as well as U.S. credit cards.
When paying by check, bank draft, or U.S. postal money order, please write your application's unique Payment Identification Number (PIN), beginning with the letters AD, on the upper right-hand corner of your completed Animal Generic Drug User Fee Cover Sheet. Also write the FDA post office box number (P.O. Box 979033) on the enclosed check, bank draft, or money order. Mail the payment and a copy of the completed Animal Generic Drug User Fee Cover Sheet to:
Food and Drug Administration
P.O. Box 979033
St. Louis, MO 63197-9000
When paying by wire transfer, the invoice number needs to be included; without the invoice number, the payment may not be applied. If the payment amount is not applied, the invoice amount would be referred to collections. The originating financial institution may charge a wire transfer fee. If the financial institution charges a wire transfer fee, it is required to add that amount to the payment to ensure that the invoice is paid in full. Use the following account information when sending a payment by wire transfer: U.S. Department of Treasury, TREAS NYC, 33 Liberty St., New York, NY 10045, FDA Deposit Account Number: 75060099, U.S. Department of Treasury routing/transit number: 021030004, SWIFT Number: FRNYUS33.
To send a check by a courier such as Federal Express, the courier must deliver the check and printed copy of the cover sheet to:
U.S. Bank
Attn: Government Lockbox 979033
1005 Convention Plaza
St. Louis, MO 63101
(Note: This address is for courier delivery only. If you have any questions concerning courier delivery, contact U.S. Bank at 314-418-4013. This telephone number is only for questions about courier delivery.)
It is important that the fee arrives at the bank at least a day or two before the application arrives at FDA's CVM. FDA records the official application receipt date as the later of the following: The date the application was received by FDA's CVM, or the date U.S. Bank notifies FDA that your payment in the full amount has been received, or when the U.S. Treasury notifies FDA of receipt of an electronic or wire transfer payment. U.S. Bank and the U.S. Treasury are required to notify FDA within 1 working day, using the PIN described previously. The tax identification number of FDA is 53-0196965. (Note: In no case should the payment for the fee be submitted to FDA with the application.)
AGDUFA has 1 fee waiver: Minor Use or Minor Species (MUMs). Please see guidance document below for more information regarding this fee waiver.
Animal Generic Drug User Fees and Fee Waivers and Reductions
2018 Reauthorization
2013 Reauthorization
2008 Law
Questions for the Animal Generic Drug User Fee staff? Email us at [email protected] or call us at 240-402-7076.