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

Samenvatting

De Food and Drug Administration (FDA) is een kennisgeving aan te passen getiteld "Fee Rate for Using a Priority Review Voucher in Fiscal Year 2026" die verscheen in het Federal Register op 18 september 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