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Federal Register / Vol. 86, No. 145 / Monday, August 2, 2021 / Notices
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VI. Procedures for Paying the Annual Fee for Periodic Reporting You will be invoiced at the end of the quarter in which your PMA Periodic Report is due. Invoices will be sent based on the details included on your PMA file. You are responsible for ensuring FDA has your current billing information, and you may update your contact information for the PMA by submitting an amendment to the pending PMA or a supplement to the approved PMA.
1. The preferred payment method is online using electronic check 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 Note: only full payments are accepted. No partial payments can be made online. Once you search for your invoice, select Pay Now to be redirected to Pay.gov. Note that electronic payment options are based on the balance due. Payment by credit card is available 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.
2. If paying with a paper check:
The check must be in U.S. currency from a U.S. bank and made payable to the Food and Drug Administration. If needed, FDAs tax identification number is 530196965.
Please write your invoice number on the check.
Mail the paper check and a copy of the invoice to: Food and Drug Administration, P.O. Box 979033, St.
Louis, MO 631979000. Please note that this address is for payments of application and annual report fees only and is not to be used for payment of annual establishment registration fees.
To send a check by a courier, 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 U.S. Bank address is for courier delivery only. If you have any questions concerning courier delivery, contact U.S. Bank at 3144184013. This telephone number is only for questions about courier delivery.
3. When paying by a wire transfer, it is required that the invoice number is 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
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institution may charge a wire transfer fee. If the financial institution charges a wire transfer fee, it is required that you add that amount to the payment to ensure that the invoice is paid in full.
Use the following account information when sending a wire transfer: U.S. Department of the Treasury, TREAS NYC, 33 Liberty St., New York, NY 10045, Acct. No.
75060099, Routing No. 021030004, SWIFT: FRNYUS33.
VII. Procedures for Paying Annual Establishment Registration Fees To pay the annual establishment registration fee, firms must access the Device Facility User Fee DFUF website at https userfees.fda.gov/OA_HTML/
furls.jsp. FDA has verified the website address, but FDA is not responsible for any subsequent changes to the website address after this document publishes in the Federal Register. Create a DFUF
order and you will be issued a PIN
when you place your order. After payment has been processed, you will be issued a payment confirmation number PCN. You will not be able to register your establishment if you do not have a PIN and a PCN. An establishment required to pay an annual establishment registration fee is not legally registered in FY 2022 until it has completed the steps below to register and pay any applicable fee see 21 U.S.C. 379jf2.
Companies that do not manufacture any product other than a licensed biologic are required to register in the Blood Establishment Registration BER
system. FDAs Center for Biologics Evaluation and Research CBER will send establishment registration fee invoices annually to these companies.
A. Submit a DFUF Order With a PIN
From FDA Before Registering or Submitting Payment To submit a DFUF Order, you must create or have previously created a user account and password for the user fee website listed previously in this section.
After creating a user name and password, log into the Establishment Registration User Fee FY 2022 store.
Complete the DFUF order by entering the number of establishments you are registering that require payment. When you are satisfied that the information in the order is accurate, electronically transmit that data to FDA according to instructions on the screen. Print a copy of the final DFUF order and note the unique PIN located in the upper righthand corner of the printed order.

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B. Pay for Your DFUF Order Unless paying by U.S. credit card, all payments must be in U. S. currency and drawn on a U.S. bank.
1. If paying by credit card or electronic check ACH or eCheck:
The DFUF order will include payment information, including details on how you can pay online using a credit card or electronic check. Follow the instructions provided to make an electronic payment.
2. If paying with a paper check:
The check must be in U.S. currency and drawn on a U.S. bank, and mailed to: Food and Drug Administration, P.O.
Box 979108, St. Louis, MO 631979000.
Note: This address is different from the address for payments of application and annual report fees and is to be used only for payment of annual establishment registration fees.
If a check is sent by a courier that requests a street address, the courier can deliver the check to: U.S. Bank, Attn:
Government Lockbox 979108, 1005
Convention Plaza, St. Louis, MO 63101.
Note: This U.S. Bank address is for courier delivery only. If you have any questions concerning courier delivery, contact U.S. Bank at 3144184013.
This telephone number is only for questions about courier delivery.
Please make sure that both of the following are written on your check: 1
The FDA post office box number P.O.
Box 979108 and 2 the PIN that is printed on your order. Include a copy of your printed order when you mail your check.
3. If paying with a wire transfer:
Wire transfers may also be used to pay annual establishment registration fees.
To send a wire transfer, please read and comply with the following information:
Include your orders unique PIN in the upper right-hand corner of your completed DFUF order in your wire transfer. Without the PIN, your payment may not be applied to your facility and your registration may be delayed.
The originating financial institution may charge a wire transfer fee. If the financial institution charges a wire transfer fee, it is required that you add that amount to the payment to ensure that the invoice is paid in full. Use the following account information when sending a wire transfer: U.S. Dept. of the Treasury, TREAS NYC, 33 Liberty St., New York, NY 10045, Acct. No.
75060099, Routing No. 021030004, SWIFT: FRNYUS33. If needed, FDAs tax identification number is 53
0196965.

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