When are user fees due?
- An application fee is due when the application is submitted to FDA.
- FDA issues invoices for annual program fees for the coming fiscal year in August of each year using the fee schedule for the coming fiscal year. Payments are due either on the first business day on or after October 1 of each fiscal year or the first business day after the enactment of an appropriations Act providing for the collection and obligation of fees for that fiscal year, whichever occurs later.
- FDA may issue additional invoices as needed. These invoices are also known as clean-up invoices to capture program fees that were not previously invoiced. The clean-up invoices are generally issued in mid-December of the fiscal year and the fees are generally due by mid-January of the fiscal year.
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 2022 begins October 1, 2021, and ends September 30, 2022.
What is the PDUFA User Fee Cover Sheet?
Form FDA 3397, the PDUFA user fee cover sheet, is designed to provide the minimum necessary information to determine whether a fee is required for review of an application, to determine the amount of the fee required, and to help FDA track payments. The PDUFA Cover Sheet Form FDA 3397 should be completed for the following:
- 505(b) and 351(a) Original Applications
- Resubmission of 505(b) and 351(a) Original Application after a Refuse to File
- Resubmission of 505(b) and 351(a) Original Applications Withdrawn before the filing date.
The form provides a cross-reference of the fee submitted for an application with the actual application by using a unique number tracking system to assign the user fee payment identification number (PIN). The information collected is used by FDA’s Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) to initiate the administrative screening of new drug applications and biologics license applications. Note: You do not need to fill out a Form 3397 for annual program fee payments.
How do I fill out the PDUFA User Fee Cover Sheet Online?
FDA offers you the ability to complete a PDUFA User Fee Cover Sheet online and submit it electronically. Please visit PDUFA User Fee Coversheet webpage to fill out the form. To fill out the form online, you need Microsoft Internet Explorer 5.5 or higher. For Step-by-Step Instructions on how to fill out the cover sheet, please visit:
https://userfees.fda.gov/OA_HTML/PDUFACScreation.pdf
How do I submit payment after completing the PDUFA User Fee Cover Sheet?
A payment may be submitted electronically via the User Fees Payment Portal or by mailing a check, bank draft, U.S. postal money order, or by wire transfer made payable to the order of the U.S. Food and Drug Administration. For all payment options, the payment must be made in U.S. currency drawn on a U.S. financial institution.
If mailing your payment, please send a printed copy of the completed PDUFA User Fee Cover Sheet along with a check, bank draft, or U.S. Postal money order made payable to the Food and Drug Administration for the fee amount due. Remember to include the user fee payment identification number, beginning with “PD,” the BLA/NDA number, and the FDA P.O. Box on the enclosed check.
Mail payment and copy of PDUFA user fee cover sheet to:
Food and Drug Administration
P.O. Box 979107
St. Louis, MO 63197-9000
Note: In no case should payment be submitted with the actual application to CDER/CBER.
If checks are to be sent by a courier that requires a street address, the courier can deliver the checks to:
U.S. Bank
Attn: Government Lockbox 979107
3180 Rider Trail South
Earth City, MO 63045
Note: This address is for courier delivery only.
Wire Transfer Payment
US Department of Treasury
TREAS NYC
33 Liberty Street
New York, NY 10045
FDA Deposit Account Number: 75060099
US Department of Treasury routing/transit number: 021030004
SWIFT Number: FRNYUS33
Beneficiary: FDA
8455 Colesville Road
COLE-14-14253
Silver Spring, MD 20993-0002
Note: For wire transfers, please include the user fee payment identification number (PIN), beginning with “PD”, the BLA/NDA number and ensure that the fee that your bank will charge for the wire transfer is added to your fee payment.
Please note for payments for annual program fees, it is helpful to include the invoice sheet that was sent to you for the annual program fees (or product or establishment fees).
If you have problems or if you are unsure on whether or not you need to file an application with FDA or are unsure what type of application to file:
Prescription Drug User Fee Staff Contact:
CDERCollections@fda.hhs.gov or 301-796-7900
Center for Biologics Evaluation and Research Contact:
Carla Vincent at 240-402-8177
If you need technical assistance with your cover sheet or are unsure how to proceed:
Contact: FDA User Fee Financial Support Team at (301) 796-7200 or userfees@fda.gov.
PDUFA User Fee Cover Sheet
OMB No. 0910-0297
Form FDA 3397 (03/19)
