For Industry

BsUFA Fee Schedule and Payment Instructions

Fee schedule for fiscal year 2015

User Fee Category FY15 Rate

BPD Fees

Initial BPD Fee $233,520
Annual BPD Fee $233,520
Reactivation Fee $467,040

Application Fees

Application requiring clinical data $2,335,200
Application not requiring clinical data $1,167,600
Supplement requiring clinical data $1,167,600

Establishment Fees

$569,200

Product Fees

$110,370

* Under section 744H(a)(2)(A) of the FD&C Act, if a sponsor that submits a biosimilar biological product application has previously paid initial BPD, annual BPD, or reactivation fees for the product that is the subject of the application, the fee for the application is reduced by the cumulative amount of these previously paid fees.

Payment instructions

  • For initial BPD, reactivation, application, and supplement fees, first complete a Biosimilar User Fee Cover Sheet, and generate a user fee identification (ID) number. 
  • Include the Biosimilar User Fee Cover Sheet with your payment and with your submission to FDA.
    • Payment must be made in U.S. currency by electronic check (ACH), wire transfer, check, bank draft, or U.S. postal money order. 

By electronic check (ACH)

  • FDA has partnered with the U.S. Department of the Treasury to utilize Pay.gov, a Web-based payment application, for online electronic payment. 
  • The Pay.gov feature is available on the FDA Web site after completing the Biosimilar User Fee Cover Sheet, and generating the user fee ID number.

By wire transfer

  • Please reference your unique user fee ID number, generated after submitting the Biosimilar User Fee Cover Sheet, when completing your transfer. 
  • The originating financial institution may assess an additional fee for wire transfer payments.  Please ask your financial institution about this fee and include it with your payment to ensure that your fee is fully paid. 
  • The account information is as follows: 

    New York Federal Reserve Bank
    U.S. Department of Treasury
    TREAS NYC
    33 Liberty Street
    New York, NY 10045
    Acct. No.:  75060099
    Routing No.:  021030004
    SWIFT:  FRNYUS33
    Beneficiary:  FDA, 8455 Colesville Road, COLE-14-14253, Silver Spring, MD 20993-0002

By check, bank draft, or postal money order

  • Please include the user fee ID number, generated after submitting the Biosimilar User Fee Cover Sheet on your check, bank draft, or postal money order, and make payable to the order of the Food and Drug Administration. 
  • Include a copy of the Biosimilar User Fee Cover Sheet with your payment.
  • Mail payment to: 

    Food and Drug Administration
    P.O. Box 979108
    St. Louis, MO 63197-9000

    Note:  In no case should payment be included with the review submission

     
  • If checks are to be sent by a courier requiring a street address, deliver the checks to:

    U.S. Bank
    Attention: Government Lockbox 979108
    1005 Convention Plaza
    St. Louis, MO 63101. 
    Note:  This U.S. Bank address is for courier delivery only. 
  • FDA issues invoices for annual BPD, establishment, and product fees.  Invoices include payment instructions.

 

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Page Last Updated: 06/15/2015
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