📄 Summary
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."
