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

<NOTICE> DEPARTMENT OF HEALTH AND HUMAN SERVICES <SUBAGY>Food and Drug Administration</SUBAGY> <DEPDOC>[Docket No. FDA-2025-N-3406]</DEPDOC> <SUBJECT>Fee Rate for Using a Priority Review Voucher in Fiscal Year 2026</SUBJECT> <HD SOURCE="HED">AGENCY:</HD> Food and Drug Administration, HHS. <HD SOURCE="HED">ACTION:</HD> Notice. <SUM> <HD SOURCE="HED">SUMMARY:</HD> The Food and Drug Administration (FDA or the Agency) is announcing the fee rate for using a priority review voucher for fiscal year (FY) 2026. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended, authorizes FDA to determine and collect priority review user fees for certain applications for review of human drug or biological products when those applications use a tropical disease, rare pediatric disease, or material threat medical countermeasure (MCM) priority review voucher. These vouchers are awarded to the sponsors of tropical disease, rare pediatric disease, or material threat MCM product applications, respectively, that meet the requirements of the FD&C Act, upon FDA approval of such applications. The amount of the fee for using a priority review voucher is determined each fiscal year, based on the difference between the average cost incurred by FDA to review a human drug application designated as priority review in the previous fiscal year, and the average cost incurred in the review of an application that is not subject to priority review in the previous fiscal year. This notice establishes 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 MCM, or tropical disease priority review voucher and outlines the payment procedures for such fees. </SUM> <DATES> <HD SOURCE="HED">DATES:</HD> This rate is effective on October 1, 2025, and will remain in effect through September 30, 2026. </DATES> <FURINF> <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD> Olufunmilayo Ariyo, Office of Financial Management, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, 240-402-4989; or the User Fees Support Staff at <E T="03">UFSS@fda.hhs.gov</E> . </FURINF> <SUPLINF> <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD> <HD SOURCE="HD1">I. Background</HD> <HD SOURCE="HD2">A. Establishment of the Tropical Disease Priority Review Voucher</HD> Section 1102 of the Food and Drug Administration Amendments Act of 2007 (Pub. L. 110-85) added section 524 to the FD&C Act (21 U.S.C. 360n). In section 524 of the FD&C Act, Congress encouraged development of new human drug and biological products for prevention and treatment of tropical diseases by offering additional incentives for obtaining FDA approval of such products. Under section 524 of the FD&C Act, the sponsor of an eligible human drug application for a tropical disease (as defined in section 524(a)(3) of the FD&C Act) shall receive a priority review voucher upon approval of the tropical disease product application (as defined in section 524(a)(4) of the FD&C Act). <HD SOURCE="HD2">B. Establishment of the Rare Pediatric Disease Priority Review Voucher</HD> Section 908 of the Food and Drug Administration Safety and Innovation Act (Pub. L. 112-144) added section 529 of the FD&C Act (21 U.S.C. 360ff). In section 529 of the FD&C Act, Congress encouraged development of new human drugs and biological products for prevention and treatment of certain rare pediatric diseases by offering additional incentives for obtaining FDA approval of such products. Under section 529 of the FD&C Act, the sponsor of an eligible human drug application for a rare pediatric disease (as defined in section 529(a)(3) of the FD&C Act) shall receive a priority review voucher upon approval of the rare pediatric disease product application (as defined in section 529(a)(4) of the FD&C Act). <SU>1</SU> <FTREF/> <FTNT> <SU>1</SU>  The FD&C Act includes a sunset of authority to award rare pediatric disease priority review vouchers. Section 529(b)(5) of the FD&C Act provides that after December 20, 2024, FDA may not award any rare pediatric disease priority review vouchers unless a rare pediatric disease product application: (1) is for a drug that, not later than December 20, 2024, is designated under section 529(d) of the FD&C Act as a drug for a rare pediatric disease, and (2) is, not later than September 30, 2026, approved under section 505(b)(1) of the FD&C Act or section 351(a) of the PHS Act. This limit of FDA's authority to award rare pediatric disease priority review vouchers does not affect the ability to use rare pediatric disease priority review vouchers issued by FDA. </FTNT> <HD SOURCE="HD2">C. Establishment of the Material Threat MCM Priority Review Voucher</HD> Section 3086 of the 21st Century Cures Act (Pub. L. 114-255) added section 565A to the FD&C Act (21 U.S.C. 360bbb-4a). In section 565A of the FD&C Act, Congress encouraged development of material threat MCMs by offering additional incentives for obtaining FDA approval of such products. Under section 565A of the FD&C Act, the sponsor of an eligible material threat MCM application (as defined in section 565A(a)(4) of the FD&C Act) shall receive a priority review voucher upon approval of the material threat MCM application. <SU>2</SU> <FTREF/> <FTNT> <SU>2</SU>  Although under section 565A(g) of the FD&C Act, material threat MCM priority review vouchers may not be awarded after October 1, 2023, this “sunset” of authority to award vouchers does not affect the ability to use material threat MCM priority review vouchers that have already been issued. </FTNT> <HD SOURCE="HD2">D. Transferability of the Priority Review Voucher</HD> The recipient of a priority review voucher may either use the voucher for a future human drug application submitted to FDA under section 505(b)(1) of the FD&C Act (21 U.S.C. 355(b)(1)) or section 351(a) of the Public Health Service Act (PHS Act) (42 U.S.C. 262(a)), or transfer (including by sale) the voucher to another party. The voucher may be transferred repeatedly until it ultimately is used for a human drug application submitted to FDA under section 505(b)(1) of the FD&C Act or section 351(a) of the PHS Act. As further described below, a priority review is a review conducted with a Prescription Drug User Fee Act (PDUFA) goal date of 6 months after the receipt or filing date, depending on the type of application. Information regarding review goals for FY 2026 is available at: <E T="03">https://www.fda.gov/media/151712/download</E> . The sponsor that uses a priority review voucher is entitled to a priority review of its eligible human drug application, but must pay FDA a priority review user fee in addition to any other fee required by PDUFA. FDA published information on its website about how the priority review voucher program operates.  Information regarding the tropical disease priority review voucher program is available at: <E T="03">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/tropical-disease-priority-review-vouchers</E> . <SU>4</SU>  Information regarding the rare pediatric disease priority review voucher program is available at: <E T="03">https://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/ucm375479.htm</E> . <SU>5</SU>  Information regarding the material threat MCM priority review voucher program is available at: <E T="03">https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/21st-century-cures-act-mcm-related-cures-provisions</E> . </FTNT> This notice establishes the FY 2026 priority review fee rate for use of tropical disease, rare pediatric disease, and material threat MCM priority review vouchers at $1,962,472 and outlines FDA's process for implementing the collection of priority review user fees. This rate is effective on October 1, 2025, and will remain in effect through September 30, 2026. <HD SOURCE="HD1">II. Priority Review User Fee Rate for FY 2026</HD> FDA interprets section 524(c)(2) (tropical disease priority review user fee), section 529(c)(2) (rare pediatric disease priority review user fee), and section 565A(c)(2) (material threat MCM priority review user fee) of the FD&C Act as requiring that FDA determine the amount of each priority review user fee for each fiscal year based on the difference between the average cost incurred by FDA in the review of a human drug application subject to priority review in the previous fiscal year, and the average cost incurred by FDA in the review of a human drug application that is not subject to priority review in the previous fiscal year. A priority review is a review conducted within a timeframe prescribed in FDA commitments for such reviews made in connection with PDUFA reauthorization for FYs 2023-2027, known as PDUFA VII. For the FYs 2023 through 2027, FDA has committed to a goal date to review and act on 90 percent of the applications granted priority review status within the expedited timeframe of 6 months after receipt or filing date (filing date for new molecular entity (NME) new drug application (NDA) and original biologics license application (BLA) submissions; receipt date for priority non-NME original NDA submissions). Normally, an application for a human drug or biological product will qualify for priority review if the product is intended to treat a serious condition and, if approved, would provide a significant improvement in safety or effectiveness. An application that does not receive a priority designation receives a standard review. A priority review involves a more intensive level of effort and a higher level of resources than a standard review. FDA is setting a fee for FY 2026, which is to be based on standard cost data from the previous fiscal year, FY 2025. However, the FY 2025 submission cohor ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ Preview showing 10k of 21k characters. Full document text is stored and available for version comparison. ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━