[Federal Register Volume 90, Number 179 (Thursday, September 18, 2025)]
[Notices]
[Pages 45041-45044]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-18075]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2025-N-3406]
Fee Rate for Using a Priority Review Voucher in Fiscal Year 2026
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: 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.
DATES: This rate is effective on October 1, 2025, and will remain in
effect through September 30, 2026.
FOR FURTHER INFORMATION CONTACT: 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 [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
A. Establishment of the Tropical Disease Priority Review Voucher
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).
B. Establishment of the Rare Pediatric Disease Priority Review Voucher
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).\1\
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\1\ 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.
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C. Establishment of the Material Threat MCM Priority Review Voucher
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
[[Page 45042]]
review voucher upon approval of the material threat MCM application.\2\
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\2\ 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.
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D. Transferability of the Priority Review Voucher
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: https://www.fda.gov/media/151712/download.
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.\3\ \4\ \5\
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\3\ Information regarding the tropical disease priority review
voucher program is available at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/tropical-disease-priority-review-vouchers.
\4\ Information regarding the rare pediatric disease priority
review voucher program is available at: https://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/ucm375479.htm.
\5\ Information regarding the material threat MCM priority
review voucher program is available at: https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/21st-century-cures-act-mcm-related-cures-provisions.
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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.
II. Priority Review User Fee Rate for FY 2026
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 cohort has not been closed out yet, thus the cost data for
FY 2025 are not complete. The latest year for which FDA has complete
cost data is FY 2024. Furthermore, because FDA has never tracked the
cost of reviewing applications that get priority review as a separate
cost subset, FDA estimated this cost based on other data that the
Agency has tracked. The Agency expects all applications that received
priority review would contain clinical data. The application categories
with clinical data for which FDA tracks the cost of review are (1) NDAs
for an NME with clinical data and (2) BLAs.
The total cost for FDA to review NME NDAs with clinical data and
BLAs in FY 2024 was $290,420,610. There was a total of 76 applications
in these 2 categories (38 NME NDAs with clinical data and 38 BLAs).
(Note: These numbers exclude the President's Emergency Plan for AIDS
Relief NDAs; no investigational new drug review costs are included in
this amount.) Of these applications, 42 (19 NDAs and 23 BLAs) received
priority review and the remaining 34 (19 NDAs and 15 BLAs) received
standard reviews. Because a priority review compresses a review that
ordinarily takes 10 months into 6 months, FDA estimates that a
multiplier of 1.67 (10 months divided by 6 months) should be applied to
nonpriority review costs in estimating the effort and cost of a
priority review as compared to a standard review. This multiplier is
consistent with published research on this subject, which supports a
priority review multiplier in the range of 1.48 to 2.35 (Ref. 1). Using
FY 2024 figures, the costs of a priority and standard review are
estimated using the following formula:
(42 [alpha] x 1.67) + (34 [alpha]) = $290,420,610
where ``[alpha]'' is the cost of a standard review and ``[alpha] times
1.67'' is the cost of a priority review. Using this formula, the cost
of a standard review for NME NDAs and BLAs is calculated to be
$2,788,752 (rounded to the nearest dollar) and the cost of a priority
review for NME NDAs and BLAs is 1.67 times that amount, or $4,657,216
(rounded to the nearest dollar). The difference between these two cost
estimates, or $1,868,464, represents the incremental cost of conducting
a priority review rather than a standard review.
For the FY 2026 fee, FDA will need to adjust the FY 2024
incremental cost by the average amount by which FDA's average costs
increased in the 3 years prior to FY 2025, to adjust the FY 2024 amount
for cost increases in FY 2025. That adjustment, published in the
Federal Register setting the FY 2026 PDUFA fees, is 5.0313 percent for
the most recent year, not compounded. Increasing the FY 2024
incremental priority review cost of $1,868,464 by 5.0313 percent (or
0.050313) results in an estimated cost of $1,962,472 (rounded to the
nearest dollar). This is the priority review user fee amount for FY
2026 that must be submitted in connection with a priority review
voucher for a human drug application in FY 2026, in addition to any
PDUFA fee that is required for such an application.
[[Page 45043]]
III. Fee Rate Schedule for FY 2026
The fee rate for FY 2026 is set in Table 1:
Table 1--Priority Review Fee Schedule for FY 2026
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Priority review fee
Fee category rate for FY 2026
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Application submitted with a tropical disease $1,962,472
priority review voucher in addition to the normal
PDUFA fee........................................
Application submitted with a rare pediatric 1,962,472
disease priority review voucher in addition to
the normal PDUFA fee.............................
Application submitted with a material threat MCM 1,962,472
priority review voucher in addition to the normal
PDUFA fee........................................
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IV. Implementation of Priority Review User Fee
Sections 524(c)(4)(B), 529(c)(4)(B), and 565A(c)(4)(B) of the FD&C
Act specify that the human drug application for which the sponsor
requests the use of a priority review voucher will be considered
incomplete if the priority review user fee and all other applicable
user fees are not paid in accordance with FDA payment procedures. In
addition, FDA may not grant a waiver, exemption, reduction, or refund
of any fees due and payable under these sections of the FD&C Act (see
sections 524(c)(4)(C), 529(c)(4)(C), and 565A(c)(4)(C)). FDA may not
collect priority review voucher fees for any fiscal year ``except to
the extent provided in advance in appropriation Acts.'' (Section
524(c)(5)(B), 529(c)(5)(B), and 565A(c)(6)) of the FD&C Act.)
The priority review fee established in the new fee schedule must be
paid for any application received on or after October 1, 2025,
submitted with a priority review voucher. As noted in section II, this
fee must be paid in addition to any PDUFA fee that is required for the
application. The sponsor would need to follow normal requirements for
timely payment of any PDUFA fee for the human drug application. For
more information regarding payment of PDUFA application fees generally,
please see section 736(a)(1) of the FD&C Act.\6\
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\6\ Additional information is also available in the guidance for
industry entitled Assessing User Fees Under the Prescription Drug
User Fee Amendments of 2022. FDA updates guidance periodically. To
make sure you have the most recent version of a guidance, check the
FDA Drugs guidance web page at: https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm.
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A. Priority Review Voucher Notification of Intent Requirement
All three priority review vouchers have a notification requirement.
To comply with this requirement, the sponsor must notify FDA not later
than 90 days prior to submission of the human drug application that is
the subject of a priority review voucher of an intent to submit the
human drug application, including the estimated submission date. See
sections 524(b)(4), 529(b)(4)(B)(i), and 565A(b)(3)(A) of the FD&C Act.
B. Priority Review Voucher User Fee Due Date
Under sections 524(c)(4)(A) (tropical disease priority review user
fee) and 565A(c)(4)(A) (material threat MCM priority review user fee)
of the FD&C Act, the priority review user fee is due (i.e., the
obligation to pay the fee is incurred) upon submission of a human drug
application for which the priority review voucher is used.\7\
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\7\ In the case of a ``rolling review'' application (as
discussed in FDA's May 2014 guidance entitled Expedited Programs for
Serious Conditions--Drugs and Biologics, available at: https://www.fda.gov/files/drugs/published/Expedited-Programs-for-Serious-Conditions-Drugs-and-Biologics.pdf) for which a tropical disease
priority review voucher or material threat MCM priority review
voucher is redeemed, FDA considers the application to be submitted
on the date FDA receives the final portion of the application that
the applicant identifies as complete. Also see section 506(d) of the
FD&C Act, relating to review of incomplete applications for approval
of a fast track product.
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Under section 529(c)(4)(A) (rare pediatric disease priority review
user fee) of the FD&C Act, the priority review user fee is due (i.e.,
the obligation to pay the fee is incurred) when a sponsor notifies FDA
of its intent to use the voucher. Upon receipt of this notification,
FDA will issue an invoice to the sponsor for the rare pediatric disease
priority review voucher fee. The invoice will include instructions on
how to pay the fee via wire transfer, electronic check, or online
payments.
V. Fee Payment Options and Procedures
A. Fee Payment Procedures
Payment must be made in U.S. currency by electronic check, wire
transfer, or credit card.\8\ The preferred payment method is online
using electronic check (Automated Clearing House (ACH) also known as
eCheck) or credit card (Discover, VISA, MasterCard, American Express).
Secure electronic payments can be submitted using the User Fees Payment
Portal at https://userfees.fda.gov/pay. (Note: Only full payments are
accepted. No partial payments can be made online.) Once you search for
your invoice, select ``Pay Now'' to be redirected to Pay.gov. Note that
electronic payment options are based on the balance due. Payment by
credit card is available for balances that are less than $25,000. If
the balance exceeds this amount, only the ACH option is available.
Payments must be made using U.S. bank accounts as well as U.S. credit
cards.
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\8\ See ``Change in Federal Payment and Collection Options''
announcement published in the Federal Register on June 27, 2025 (90
FR 27639).
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FDA has partnered with the U.S. Department of the Treasury to use
Pay.gov, a web-based payment application, for online electronic
payment. The Pay.gov feature is available on the FDA website after the
user fee identification (ID) number is generated.
B. Wire Transfer Payment Process
If paying by wire transfer, please reference your invoice number/
unique user fee ID number when completing your transfer. (For rare
pediatric disease priority review, please use your invoice number
issued by FDA upon receipt of notification. For all other priority
reviews, please use the unique user fee ID number generated for the
Pay.gov feature.) The originating financial institution may charge a
wire transfer fee. If the financial institution charges a wire transfer
fee, it is required to add that amount to the payment to ensure that
the invoice is paid in full. The account information is as follows:
U.S. Dept. of the Treasury, TREAS NYC, 33 Liberty St., New York, NY
10045, Account Number: 75060099, Routing Number: 021030004, SWIFT:
FRNYUS33. If needed, FDA's tax identification number is 53-0196965.
VI. Reference
The following reference is on display with the Dockets Management
Staff
[[Page 45044]]
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852, 240-402-7500, and is available for viewing by
interested persons between 9 a.m. and 4 p.m., Monday through Friday; it
is not available electronically at https://www.regulations.gov as this
reference is copyright protected. FDA has verified the website address
as of the date this document publishes in the Federal Register, but
websites are subject to change over time.
1. Ridley, D.B., H.G. Grabowski, and J.L. Moe, ``Developing Drugs
for Developing Countries,'' Health Affairs, vol. 25, no. 2, pp. 313-
324, 2006, available at: https://www.healthaffairs.org/doi/full/10.1377/hlthaff.25.2.313.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-18075 Filed 9-17-25; 8:45 am]
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