Notice2026-18464
Fee Rate for Using a Priority Review Voucher in Fiscal Year 2027
Primary source
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Published
September 10, 2026
Effective
October 1, 2026
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or the Agency) is announcing the fee rate for using a priority review voucher for fiscal year (FY) 2027. 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 2027 priority review fee rate applicable to submission of eligible applications for review of human drug or biological products using a tropical disease, rare pediatric disease, or material threat MCM priority review voucher and outlines the payment procedures for such fees.
Full Text
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<title>Federal Register, Volume 91 Issue 174 (Thursday, September 10, 2026)</title>
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[Federal Register Volume 91, Number 174 (Thursday, September 10, 2026)]
[Notices]
[Pages 57617-57619]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-18464]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2026-N-9047]
Fee Rate for Using a Priority Review Voucher in Fiscal Year 2027
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) 2027. 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 2027 priority review fee rate applicable
to submission of eligible applications for review of human drug or
biological products using a tropical disease, rare pediatric disease,
or material threat MCM priority review voucher and outlines the payment
procedures for such fees.
DATES: This rate is effective on October 1, 2026, and will remain in
effect through September 30, 2027.
FOR FURTHER INFORMATION CONTACT: Olufunmilayo Ariyo, Office of
Financial Management, Food and Drug Administration, 301-796-7900; or
<a href="/cdn-cgi/l/email-protection#b4f2f0f5e1c7d1c6f2d1d1c7f4d2d0d59adcdcc79ad3dbc2"><span class="__cf_email__" data-cfemail="aaeceeebffd9cfd8eccfcfd9eacccecb84c2c2d984cdc5dc">[email protected]</span></a>.
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 September 30, 2029, FDA may not award
any rare pediatric disease priority review vouchers. 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 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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A priority review involves a more intensive level of effort and a
higher level of resources than a standard review.\3\ 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).
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\3\ For more information on priority review designation, see
FDA's May 2014 guidance entitled Expedited Programs for Serious
Conditions--Drugs and Biologics, available at: <a href="https://www.fda.gov/files/drugs/published/Expedited-Programs-for-Serious-Conditions-Drugs-and-Biologics.pdf">https://www.fda.gov/files/drugs/published/Expedited-Programs-for-Serious-Conditions-Drugs-and-Biologics.pdf</a>.
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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 2027 is available at: <a href="https://www.fda.gov/media/151712/download">https://www.fda.gov/media/151712/download</a>.
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.<SUP>4 5 6</SUP>
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\4\ Information regarding the tropical disease priority review
voucher program is available at: <a href="https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/tropical-disease-priority-review-voucher-program">https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/tropical-disease-priority-review-voucher-program</a>.
\5\ Information regarding the rare pediatric disease priority
review voucher program is available at: <a href="https://www.fda.gov/industry/medical-products-rare-diseases-and-conditions/rare-pediatric-disease-designation-and-priority-review-voucher-programs">https://www.fda.gov/industry/medical-products-rare-diseases-and-conditions/rare-pediatric-disease-designation-and-priority-review-voucher-programs</a>.
\6\ Information regarding the material threat MCM priority
review voucher program is available at: <a href="https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/21st-century-cures-act-mcm-related-cures-provisions">https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/21st-century-cures-act-mcm-related-cures-provisions</a>.
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This notice establishes the FY 2027 priority review fee rate for
use of tropical disease, rare pediatric disease, and material threat
MCM priority review vouchers at $1,798,596 and outlines FDA's process
for implementing the collection of priority review user fees. This rate
is effective on October 1, 2026, and will remain in effect through
September 30, 2027.
II. Priority Review User Fee Rate for FY 2027
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.
FDA is setting a fee for FY 2027, which is to be based on standard
cost data from the previous fiscal year, FY 2026. However, the FY 2026
submission cohort has not been closed out yet, thus the cost data for
FY 2026 are not complete. The latest year for which FDA has complete
cost data is FY 2025. 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 2025 was $259,267,306. There was a total of 73 applications
in these 2 categories (44 NME NDAs with clinical data and 29 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 (24 NDAs and 18 BLAs) received
priority reviews and the remaining 31 (20 NDAs and 11 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 2025 figures, the costs of a priority and standard review are
estimated using the following formula:
(42 [alpha] x 1.67) + (31 [alpha]) = $259,267,306 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 $2,563,450 (rounded to the
nearest dollar) and the cost of a priority review for NME NDAs and BLAs
is 1.67 times that amount, or $4,280,962 (rounded to the nearest
dollar). The difference between these two cost estimates, or
$1,717,512, represents the incremental cost of conducting a priority
review rather than a standard review.
For the FY 2027 fee, FDA will need to adjust the FY 2025
incremental cost by the average amount by which FDA's average costs
increased in the 3 years prior to FY 2026, to adjust the FY 2025 amount
for cost increases in FY 2026. That adjustment, published in the
Federal Register setting the FY 2027 PDUFA fees, is 4.7210 percent for
the most recent year, not compounded. Increasing the FY 2025
incremental priority review cost of $1,717,512 by 4.7210 percent (or
0.047210) results in an estimated cost of $1,798,596 (rounded to the
nearest dollar). This is the priority review user fee amount for FY
2027 that must be submitted in connection with a priority review
voucher for a human drug application in FY 2027, in addition to any
PDUFA fee that is required for such an application.
III. Fee Rate Schedule for FY 2027
The fee rate for FY 2027 is set in Table 1:
Table 1--Priority Review Fee Schedule for FY 2027
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Priority
review fee
Fee category rate for FY
2027
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Application submitted with a tropical disease priority $1,798,596
review voucher in addition to the normal PDUFA fee.....
Application submitted with a rare pediatric disease 1,798,596
priority review voucher in addition to the normal PDUFA
fee....................................................
Application submitted with a material threat MCM 1,798,596
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, 2026,
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.\7\
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\7\ 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: <a href="https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm">https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm</a>.
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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), 529(c)(4)(A) (rare pediatric 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.\8\
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\8\ 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: <a href="https://www.fda.gov/files/drugs/published/Expedited-Programs-for-Serious-Conditions-Drugs-and-Biologics.pdf">https://www.fda.gov/files/drugs/published/Expedited-Programs-for-Serious-Conditions-Drugs-and-Biologics.pdf</a>) for which a tropical disease
priority review voucher, rare pediatric 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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V. Fee Payment Options and Procedures
Payments made to FDA must be made in U.S. currency drawn on a U.S.
bank by electronic check, credit card, or wire transfer. The preferred
method for payments to FDA is online using electronic check (Automated
Clearing House (ACH), also known as eCheck) or credit card (Discover,
VISA, MasterCard, American Express). FDA has partnered with the U.S.
Department of the Treasury to utilize <a href="http://Pay.gov">Pay.gov</a>, a web-based payment
application, for online electronic payment. The <a href="http://Pay.gov">Pay.gov</a> feature is
available on the FDA website upon receipt of an invoice.
Secure electronic payments to FDA can be submitted using the User
Fees Payment Portal at <a href="https://userfees.fda.gov/pay">https://userfees.fda.gov/pay</a>. (Note: Only full
payments are accepted; no partial payments can be made online.) Once an
invoice is located, ``Pay Now'' should be selected to be redirected to
<a href="http://Pay.gov">Pay.gov</a>. Electronic payment options are based on the balance due.
Payment by credit card is available for balances 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.
For payments made by wire transfer, include the invoice number to
ensure that the payment is applied to the correct fee(s). Without the
invoice number, the payment may not be applied. The originating
financial institution may charge a wire transfer fee. Include
applicable wire transfer fees with payment to ensure fees are fully
paid. Questions about wire transfer fees should be addressed to the
financial institution. The following account information should be used
to send payments by wire transfer: U.S. Department of the Treasury,
TREAS NYC, 33 Liberty St., New York, NY 10045, Account No: 75060099,
Routing No: 021030004, SWIFT: FRNYUS33.
FDA's tax identification number is 53-0196965. If a fee is not paid
in full, the fee will be treated as a claim of the U.S. Government (see
45 CFR part 30), meaning the invoice balance due amount is referred to
collections.
VI. Reference
The following reference is on display with the Dockets Management
Staff (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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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: <a href="https://www.healthaffairs.org/doi/full/10.1377/hlthaff.25.2.313">https://www.healthaffairs.org/doi/full/10.1377/hlthaff.25.2.313</a>.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-18464 Filed 9-9-26; 8:45 am]
BILLING CODE 4164-01-P
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