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Federal Register / Vol. 86, No. 145 / Monday, August 2, 2021 / Notices
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2. A National Taxing Authority Certification, completed by, and bearing the official seal of, the National Taxing Authority of the country in which the firm is headquartered. This certification must show the amount of gross receipts or sales for the most recent tax year, in both U.S. dollars and the local currency of the country, the exchange rate used in converting the local currency to U.S.
dollars, and the dates of the gross receipts or sales collected.
3. For each of your affiliates, either:
If the affiliate is a domestic U.S.
business, a signed copy of the affiliates Federal U.S. Income Tax Return for the most recent tax year 2021 or later, or If the affiliate is a foreign business and cannot submit a Federal U.S.
Income Tax Return, a National Taxing Authority Certification completed by, and bearing the official seal of, the National Taxing Authority of the country in which the firm is headquartered. The National Taxing Authority is the foreign equivalent of the U.S. Internal Revenue Service. This certification must show the amount of gross receipts or sales for the most recent tax year, in both U.S. dollars and the local currency of the country, the exchange rate used in converting the local currency to U.S. dollars, and the dates for the gross receipts or sales collected. The business must also submit a statement signed by the head of the businesss firm or by its chief financial officer that the applicant has submitted certifications for all of its affiliates, identifying the name of each affiliate, or that the business has no affiliates.
V. Procedures for Paying Application Fees If your application or submission is subject to a fee and your payment is received by FDA between October 1, 2021, and September 30, 2022, you must pay the fee in effect for FY 2022. To avoid delay in the review of your application, you should pay the application fee before or at the time you submit your application to FDA. The later of the date that the application is received in the reviewing centers document room or the date the U.S.
Treasury recognizes the payment determines whether the fee rates for FY
2021 or FY 2022 apply. FDA must receive the correct fee at the time that an application is submitted, or the application will not be accepted for filing or review.
FDA requests that you follow the steps below before submitting a medical device application subject to a fee to ensure that FDA links the fee with the correct application. Note: Do not send
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your user fee check to FDA with the application.
A. Secure a Payment Identification Number PIN and Medical Device User Fee Cover Sheet From FDA Before Submitting Either the Application or the Payment Log into the User Fee System at:
https userfees.fda.gov/OA_HTML/
mdufmaCAcdLogin.jsp. Complete the Medical Device User Fee cover sheet. Be sure you choose the correct application submission date range. Two choices will be offered until October 1, 2021.
One choice is for applications and fees that will be received on or before September 30, 2021, which are subject to FY 2021 fee rates. A second choice is for applications and fees received on or after October 1, 2021, which are subject to FY 2022 fee rates. After completing data entry, print a copy of the Medical Device User Fee cover sheet and note the unique PIN located in the upper right-hand corner of the printed cover sheet.
B. Electronically Transmit a Copy of the Printed Cover Sheet With the PIN
When you are satisfied that the data on the cover sheet is accurate, electronically transmit that data to FDA
according to instructions on the screen.
Applicants are required to set up a user account and password to assure data security in the creation and electronic submission of cover sheets.
C. Submit Payment for the Completed Medical Device User Fee Cover Sheet 1. 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. FDA has partnered with the U.S. Department of the Treasury to utilize Pay.gov, a web-based payment system, for online electronic payment.
You may make a payment via electronic check or credit card after submitting your cover sheet. 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.
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:

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All paper checks 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 applications unique PIN from the upper right-hand corner of your completed Medical Device User Fee cover sheet on your check.
Mail the paper check and a copy of the completed cover sheet 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.
If you prefer to send a check by a courier, the courier may deliver the check 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. If paying with a wire transfer:
Please include your applications unique PIN from the upper right-hand corner of your completed Medical Device User Fee cover sheet in your wire transfer. Without the PIN, your payment may not be applied to your cover sheet and review of your application 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. Department of the Treasury, TREAS NYC, 33 Liberty St., New York, NY 10045, Acct. No.
75060099, Routing No. 021030004, SWIFT: FRNYUS33.
FDA records the official application receipt date as the later of the following:
1 The date the application was received by the FDA Document Control Center for the reviewing Center or 2
the date the U.S. Treasury recognizes the payment. It is helpful if the fee arrives at the bank at least 1 day before the application arrives at FDA.
D. Submit Your Application to FDA
With a Copy of the Completed Medical Device User Fee Cover Sheet Please submit your application and a copy of the completed Medical Device User Fee cover sheet to the address located at https www.fda.gov/
cdrhsubmissionaddress.

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