Fee Rate for Using a Priority Review Voucher in Fiscal Year 2026; Correction

Fee Rate for Using a Priority Review Voucher in Fiscal Year 2026; Correction

SUPPLEMENTARY INFORMATION:

In the Federal Register of September 18, 2025 (90 FR 45041), in FR Doc. 2025-18075, the following corrections are made:

1. On page 45041, in the third column, the second sentence in footnote #1 is revised to state only the following: "Section 529(b)(5) of the FD&C Act provides that after September 30, 2029, FDA may not award any rare pediatric disease priority review vouchers."

2. On page 45043, in the second column, in section IV.B titled "Priority Review Voucher User Fee Due Date," the first sentence is revised to state, "Under sections 524(c)(4)(A) (tropical disease priority review user fee), 529(c)(4)(A) (rare pediatric disease priority review user fee), and 565A(c)(4)(A) (material threat MCM priority review user fee) of the FD&C Act, the priority review user fee is due ( i.e., the obligation to pay the fee is incurred) upon submission of a human drug application for which the priority review voucher is used." The second paragraph in section IV.B is removed. A new paragraph is inserted: "Given the recent amendment to section 529, FDA is updating the electronic Form FDA 3397, Prescription Drug User Fee Coversheet to allow sponsors the option to select for use of a rare pediatric disease priority review voucher. Generally, if a sponsor selects for use of a tropical disease, material threat MCM, or rare pediatric disease priority review voucher on Form FDA 3397, the form will be placed on hold while FDA completes its review of the priority review voucher redemption. Once the hold is lifted, a sponsor can proceed with submission of the completed Form FDA 3397 and payment of the applicable fees." Footnote #7 is revised to state, "In the case of a "rolling review" application (as discussed in FDA's May 2014 guidance entitled Expedited Programs for Serious Conditions-Drugs and Biologics, available at: https://www.fda.gov/files/drugs/published/Expedited-Programs-for-Serious-Conditions-Drugs-and-Biologics.pdf ) for which a tropical disease priority review voucher, rare pediatric disease priority review voucher, or material threat MCM priority review voucher is redeemed, FDA considers the application to be submitted on the date FDA receives the final portion of the application that the applicant identifies as complete."

3. On page 45043, in the third column, in section V.B titled "Wire Transfer Payment Process," the second sentence is deleted, and the third sentence is revised as follows: "For all priority reviews, please use the unique user fee ID number generated for the Pay.gov feature.)"