Federal Register #FDA-2026-N-9047

FDA Announces FY 2027 Priority Review Voucher Fee and Rural Hospital Supplemental Funding

This notice from the Food and Drug Administration (FDA), part of the Department of Health and Human Services, announces the FY 2027 fee rate for using a priority review voucher for human drug or biological product applications. - Government Buyer: - Department of Health and Human Services - Food and Drug Administration (FDA) - Products/Services Requested: - Priority Review User Fee for: - Tropical Disease Priority Review Voucher - Rare Pediatric Disease Priority Review Voucher - Material Threat Medical Countermeasure (MCM) Priority Review Voucher - Each fee is $1,798,596 for FY 2027 - Supplemental funding for the Medicare Rural Hospital Flexibility Program to support Critical Access Hospitals - Unique or Notable Requirements: - Fee applies to sponsors submitting eligible human drug or biological product applications using a priority review voucher - Fee is in addition to standard Prescription Drug User Fee Act (PDUFA) fees - Sponsors must notify FDA at least 90 days before application submission to use a voucher - Supplemental funding aims to strengthen rural hospital quality and access - No specific OEMs or commercial vendors are mentioned, as this is a regulatory fee announcement and grant funding notice, not a procurement of products or services.

Description

The Food and Drug Administration (FDA) announces the fee rate for using a priority review voucher for fiscal year 2027. These vouchers apply to certain human drug or biological product applications related to tropical disease, rare pediatric disease, or material threat medical countermeasure (MCM) priority review vouchers. The fee is based on the difference in FDA's average review costs for priority versus standard reviews from the previous fiscal year. The fee rate for FY 2027 is set at $1,798,596 and is effective from October 1, 2026, through September 30, 2027.

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