Fee Rate for Using a Priority Review Voucher in Fiscal Year 2026; Correction
The Food and Drug Administration (FDA) is amending a notice entitled "Fee Rate for Using a Priority Review Voucher in Fiscal Year 2026" that appeared in the Federal Register on ...
The Food and Drug Administration (FDA) is amending a notice entitled “Fee Rate for Using a Priority Review Voucher in Fiscal Year 2026” that appeared in the
Federal Register
on September 18, 2025. The notice established the FY 2026 priority review fee rate applicable to submission of eligible applications for review of human drug or biological products using a rare pediatric disease, material threat medical countermeasure, or tropical disease priority review voucher and outlined the payment procedures for such fees. This amendment is being made to reflect that on February 3, 2026, Congress amended section 529 of the FD&C Act, including to require a sponsor of a human drug application that is the subject of a rare pediatric disease priority review voucher to submit a priority review user fee “upon the submission of a human drug application under section 505(b)(1) or section 351(a) of the Public Health Service Act for which the priority review voucher is used.”
FOR FURTHER INFORMATION CONTACT:
Quyen Tran, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Room 5324, Silver Spring, MD 20993-0002, 301-796-2771,
CDER_ARC_Program@fda.hhs.gov.
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
( printed page 47253)
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.)”
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
Use this for formal legal and research references to the published document.
91 FR 47252
Web Citation
Suggested Web Citation
Use this when citing the archival web version of the document.
“Fee Rate for Using a Priority Review Voucher in Fiscal Year 2026; Correction,” thefederalregister.org (July 28, 2026), https://thefederalregister.org/documents/2026-15147/fee-rate-for-using-a-priority-review-voucher-in-fiscal-year-2026-correction.