Animal Drug User Fee Act (ADUFA)
|User Fee Type||FY 2019||FY 2018|
|Application Fees - Full||$449,348||$238,100|
|Application Fees - Supplemental||$224,674||$119,050|
|Product||$ 10,747||$ 6,175|
The ADUFA, originally signed into law in 2003 and reauthorized in 2008, 2013 and 2018, amends the Federal Food, Drug, and Cosmetic Act and authorizes the FDA to collect fees for certain animal drug applications and supplements, products, establishments, and sponsors of animal drug applications and/or investigational animal drug submissions. These resources support the FDA’s responsibilities to ensure that new animal drug products are safe and effective for animals, as well as ensuring the safety of food from treated animals. ADUFA IV reauthorizes the FDA to collect user fees through FY 2023.
- ADUFA IV Performance Goals Letter
- ADUFA Implementation Letter: Passage of the Animal Drug User Fee Act of 2003
- Statement on Signing the Animal Drug User Fee Act of 2003
- Animal Drug User Fee Act Performance Goals and Procedures
What is an animal drug application fee?
- Each person that submits an animal drug application or a supplemental animal drug application shall be subject to an application fee. The term "animal drug application" means an application for approval of any new animal drug submitted under section 512(b)(1) or an application for conditional approval of a new animal drug submitted under section 571 of the FD&C Act. As the expanded definition of “animal drug application” includes applications for conditional approval submitted under section 571 of the FD&C Act, such applications are now subject to ADUFA fees, except that fees may be waived if the drug is intended solely to provide for a minor use or minor species (MUMS) indication.
- Prior to ADUFA IV, FDA only had authority to grant conditional approval for drugs intended for a MUMS indication. Under ADUFA IV, FDA retains authority to grant conditional approval for drugs intended for MUMS indications but also will be able to grant conditional approval for certain drugs not intended for a MUMS indication provided certain criteria are met. Beginning with FY 2019, ADUFA IV provides an exception from application fees for animal drug applications submitted under section 512(b)(1) of the FD&C Act if the application is submitted by a sponsor who previously applied for conditional approval under the new non-MUMS pathway of section 571 for the same product and paid an application fee at the time they applied for conditional approval. The purpose of this exception is to prevent sponsors of conditionally approved products from having to pay a second application fee at the time they apply for full approval of their products under section 512(b)(1) of the FD&C Act, provided the sponsor’s application for full approval is filed consistent with the timeframes established in section 571(h) of the FD&C Act.
- A "supplemental animal drug application" is defined as a request to the Secretary to approve a change in an animal drug application which has been approved, or a request to the Secretary to approve a change to an application approved under section 512(c)(2) of the FD&C Act for which data with respect to safety or effectiveness are required.
- 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 ADUFA’s annual fees?
ADUFA has 3 annual fees. Sponsor, Product and Establishment. These fees are assessed annually.
What is a Sponsor Fee?
- The animal drug sponsor fee must be paid annually by each person who: (1) Is named as the applicant in an animal drug 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 animal drug submission that has not been terminated or otherwise rendered inactive and (2) had an animal drug application, supplemental animal drug application, or investigational animal drug submission pending at FDA after September 1, 2003.
- An animal drug sponsor is subject to only one fee each fiscal year.
Guidance documents for additional Sponsor fee information:
- CVM GFI #173 Animal Drug Sponsor Fees Under the Animal Drug User Fee Act (ADUFA)
- CVM GFT #173 Appendix for the Animal Drug Sponsor Fees Under the ADUFA
What is a Product Fee?
- The animal drug product fee must be paid annually by the person named as the applicant in a new animal drug application or supplemental new animal drug application for an animal drug product submitted for listing under section 510 of the FD&C Act, and who had an animal drug application or supplemental animal drug application pending at FDA after September 1, 2003.
- The term "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 an animal drug application or a supplemental animal drug application has been approved.
- Each NDC is assessed 1 product fee.
What is an Establishment Fee?
- The animal drug establishment fee must be paid annually by the person who: (1) Owns or operates, directly or through an affiliate, an animal drug establishment; (2) is named as the applicant in an animal drug application or supplemental animal drug application for an animal drug product submitted for listing under section 510 of the FD&C Act; (3) had an animal drug application or supplemental animal drug application pending at FDA after September 1, 2003; and (4) whose establishment engaged in the manufacture of the animal drug product during the fiscal year.
- An establishment subject to animal drug establishment fees is assessed only one such fee per fiscal year. The term "animal drug establishment" is defined as a foreign or domestic place of business which is at one general physical location consisting of one or more buildings all of which are within five miles of each other, at which one or more animal drug products are manufactured in final dosage form.
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, establishment and product fees are due annually.
- FDA issues Initial invoices for sponsor, establishment 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 animal drug application or supplement subject to fees under ADUFA IV 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 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 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:
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.)
ADUFA has 5 fee waivers: Significant Barrier to Innovation (BI), Fees Exceed Costs (FEC), Free Choice Feeds (FT), Minor Use or Minor Species (MUMs), and Small Business (SB). Please see guidance documents below for more information regarding these fee waivers.
- Secretary's Letter re: User Fees Goals and Procedures
- ADUFA Reauthorization Performance Goals and Procedures