2023-21989. User Fee Rates for Fiscal Year 2024; Change of Address

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is providing notice that the courier address for the U.S. Bank will change. This change has a direct impact on the Fiscal Year 2024 Federal Register notices for the following FDA User Fee programs: Prescription Drug User Fee Amendments (PDUFA), Medical Device User Fee Amendments (MDUFA), Generic Drug User Fee Amendments (GDUFA), Biosimilar User Fee Amendments (BsUFA), Food Safety Modernization Act (FSMA), and Compounding Quality Act (CQA). The new physical address will be 3180 Rider Trail South, Earth City, MO 63045.

FOR FURTHER INFORMATION CONTACT:

Olufunmilayo Ariyo, Office of Financial Management, Food and Drug Administration, 4041 Powder Mill Rd., Rm. 62080, Beltsville, MD 20705–4304, 240–402–4989; or the User Fees Support Staff at [e-mail].

SUPPLEMENTARY INFORMATION:

The purpose of this notice is to inform the public that the physical address for overnight packages for the U.S. Bank will change on October 6, 2023. The building's street address has changed from 1005 Convention Plaza, St. Louis, MO 63101, to 3180 Rider Trail South, Earth City, MO 63045. The last date to use the old address to deliver a check by courier, such as Federal Express or UPS, is October 5, 2023, and payers must use the new address for any packages beginning October 6, 2023, to prevent any disruption to the processing of their overnight package payments. Note that this new address is for courier delivery only.

If checks are to be sent by a courier that requires a street address, the courier can deliver the checks to:

• For CQA and MDUFA: U.S. Bank, ATTN: Government Lockbox 979033, 3180 Rider Trail South, Earth City, MO 63045.

• For BsUFA, FSMA, and GDUFA: U.S. Bank, ATTN: Government Lockbox 979108, 3180 Rider Trail South, Earth City, MO 63045.

• For PDUFA: U.S. Bank, ATTN: Government Lockbox 979107, 3180 Rider Trail South, Earth City, MO 63045.

If you have any questions concerning courier delivery, contact U.S. Bank at 800–495–4981. This phone number is only for questions about courier delivery.

Note that the address for payments made by mail has not changed and should continue to be mailed to:

• CQA and MDUFA: Food and Drug Administration, P.O. Box 979033, St. Louis, MO 63197–9000.

• For BsUFA, FSMA, and GDUFA: Food and Drug Administration, P.O. Box 979108, St. Louis, MO 63197–9000.

• For PDUFA: Food and Drug Administration, P.O. Box 979107, St. Louis, MO 63197–9000.

If a check, bank draft, or U.S. postal money order is submitted, make it payable to the order of the Food and Drug Administration and include the user fee ID number to ensure that the payment is applied to the correct fee(s). The FDA post office box number must be written on the check, bank draft, or U.S. postal money order.

In addition, note that the information for payments made by wire transfer has not changed, and must include the unique user fee ID number to ensure that the payment is applied to the correct fee(s). Without the unique user fee ID number, the payment may not be applied. If the payment amount is not applied, the invoice amount will be referred to collections. The originating financial institution may charge a wire transfer fee. Include applicable wire transfer fees with payment to ensure fees are fully paid. Questions about wire transfer fees should be addressed to the financial institution. The following account information should continue to be used to send payments by wire transfer: U.S. Department of the Treasury, TREAS NYC, 33 Liberty St., New York, NY 10045, account number: 75060099, routing number: 021030004, SWIFT: FRNYUS33.

FDA's tax identification number is 53–0196965. (Note: Invoice copies do not need to be submitted to FDA with the payments.)

Dated: September 29, 2023.

Lauren K. Roth,

Associate Commissioner for Policy.