Federal Register #Docket No. FDA-2025-N-3406

FDA Correction Notice: Priority Review Voucher Fee Rate Update for FY 2026

This notice from the Food and Drug Administration (FDA) provides a correction regarding the fee rate for using a priority review voucher in fiscal year 2026. - Government Buyer: - Department of Health and Human Services (HHS) - Food and Drug Administration (FDA) - No OEMs, vendors, or commercial products are mentioned - No procurement of goods or services is being requested - Key Details: - Correction clarifies the fee rate and payment procedures for sponsors using a rare pediatric disease priority review voucher - Sponsors must pay the priority review user fee when submitting a human drug application under section 505(b)(1) or section 351(a) - Notice reflects legislative changes to section 529 of the FD&C Act - No product or service line items are included in this notice

Description

The Food and Drug Administration (FDA) is amending a prior notice regarding the fee rate for using a priority review voucher in fiscal year 2026. The amendment reflects legislative changes made by Congress on February 3, 2026, to section 529 of the FD&C Act. These changes require sponsors of human drug applications using a rare pediatric disease priority review voucher to submit the priority review user fee upon submission of the application under specified sections of the Public Health Service Act. The notice outlines updated payment procedures and fee obligations for such vouchers.

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