Notice2024-21433
Fee Rate for Using a Priority Review Voucher in Fiscal Year 2025
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
September 19, 2024
Effective
October 1, 2024
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) 2025. 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 2025 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.
Full Text
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<title>Federal Register, Volume 89 Issue 182 (Thursday, September 19, 2024)</title>
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[Federal Register Volume 89, Number 182 (Thursday, September 19, 2024)]
[Notices]
[Pages 76846-76849]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-21433]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-N-4246]
Fee Rate for Using a Priority Review Voucher in Fiscal Year 2025
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) 2025. 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 2025 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, 2024, and will remain in
effect through September 30, 2025.
FOR FURTHER INFORMATION CONTACT: Olufunmilayo Ariyo, Office of
Financial Management, Food and Drug Administration, 4041 Powder Mill
Rd., 6th Floor, Beltsville, MD 20705-4304, 240-402-4989; or the User
Fees Support Staff at <a href="/cdn-cgi/l/email-protection#0a454527454c484b5a27454c47275f4c5959274d657c6f7864676f647e4a6c6e6b24626279246d657c"><span class="__cf_email__" data-cfemail="2a656507656c686b7a07656c67077f6c7979076d455c4f5844474f445e6a4c4e4b04424259044d455c">[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 for a rare
pediatric disease (as defined in section 529(a)(3)) 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, 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 September 30, 2024, is designated under section 529(d) of
the 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 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)) 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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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 2025 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>3 4 5</SUP>
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\3\ Information regarding the tropical disease priority review
voucher program is available at: <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/tropical-disease-priority-review-vouchers">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/tropical-disease-priority-review-vouchers</a>.
\4\ Information regarding the rare pediatric disease priority
review voucher program is available at: <a href="https://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/ucm375479.htm">https://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/ucm375479.htm</a>.
\5\ 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 2025 priority review fee rate for
use of
[[Page 76847]]
tropical disease, rare pediatric disease, and material threat MCM
priority review vouchers at $2,482,446 and outlines FDA's process for
implementing the collection of priority review user fees. This rate is
effective on October 1, 2024, and will remain in effect through
September 30, 2025.
II. Priority Review User Fee Rate for FY 2025
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 2025, which is to be based on standard
cost data from the previous fiscal year, FY 2024. However, the FY 2024
submission cohort has not been closed out yet, thus the cost data for
FY 2024 are not complete. The latest year for which FDA has complete
cost data is FY 2023. 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 2023 was $305,296,115. There was a total of 61 applications
in these 2 categories (34 NME NDAs with clinical data and 27 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, 37 (19 NDAs and 18 BLAs) received
priority review and the remaining 24 (15 NDAs and 9 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 2023 figures, the costs of a priority and standard review are
estimated using the following formula:
(37 [alpha] x 1.67) + (24 [alpha]) = $305,296,115
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
$3,558,645 (rounded to the nearest dollar) and the cost of a priority
review for NME NDAs and BLAs is 1.67 times that amount, or $5,942,937
(rounded to the nearest dollar). The difference between these two cost
estimates, or $2,384,292, represents the incremental cost of conducting
a priority review rather than a standard review.
For the FY 2025 fee, FDA will need to adjust the FY 2023
incremental cost by the average amount by which FDA's average costs
increased in the 3 years prior to FY 2024, to adjust the FY 2023 amount
for cost increases in FY 2024. That adjustment, published in the
Federal Register setting the FY 2025 PDUFA fees, is 4.1167 percent for
the most recent year, not compounded. Increasing the FY 2023
incremental priority review cost of $2,384,292 by 4.1167 percent (or
0.041167) results in an estimated cost of $2,482,446 (rounded to the
nearest dollar). This is the priority review user fee amount for FY
2025 that must be submitted with a priority review voucher for a human
drug application in FY 2025, in addition to any PDUFA fee that is
required for such an application.
III. Fee Rate Schedule for FY 2025
The fee rate for FY 2025 is set in table 1:
Table 1--Priority Review Fee Schedule for FY 2025
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Priority review fee
Fee category rate for FY 2025
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Application submitted with a tropical disease $2,482,446
priority review voucher in addition to the normal
PDUFA fee........................................
Application submitted with a rare pediatric 2,482,446
disease priority review voucher in addition to
the normal PDUFA fee.............................
Application submitted with a material threat MCM 2,482,446
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
[[Page 76848]]
October 1, 2024, 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: <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 or biological
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), 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 ``rolling review'' of an 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 (PRV) or material threat MCM PRV is
redeemed, the PRV fee is due upon submission of the final portion of
the application, given that the Agency generally views ``submission
of a human drug application'' (including as used in sections
524(c)(4)(A) and 565A(c)(4)(A)) to mean the submission of a complete
application. 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, check, or online payments.
V. Fee Payment Options and Procedures
Payment must be made in U.S. currency by electronic check, check,
bank draft, wire transfer, credit card, or U.S. postal money order
payable to the order of the Food and Drug Administration. The preferred
payment method is online using electronic check (Automated Clearing
House (ACH) also known as eCheck). Secure electronic payments 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 you search for your invoice,
select ``Pay Now'' to be redirected to <a href="http://Pay.gov">Pay.gov</a>. 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.
FDA has partnered with the U.S. Department of the Treasury to use
<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 after the
user fee identification (ID) number is generated.
A. Paper Check Payment Process
If paying by paper check, the sponsor should include on the check
the appropriate reference number and the type of review requested. For
rare pediatric disease priority review, please use the invoice number
issued by FDA. The invoice number is issued by FDA upon receipt of the
rare pediatric disease priority review notification (see section IV.A).
For tropical disease priority review and for material threat MCM
priority review, please use the user fee ID number generated for the
<a href="http://Pay.gov">Pay.gov</a> feature.
Tropical disease priority review: A paper check for a tropical
disease priority review fee should include the user fee ID number and
the words: ``Tropical Disease Priority Review''.
Rare pediatric disease priority review: A paper check for a rare
pediatric disease priority review fee should include the invoice number
followed by the words: ``Rare Pediatric Disease Priority Review''.
Material threat MCM priority review: A paper check for a material
threat MCM priority review fee should include the user fee ID number
and the words: ``Material Threat Medical Countermeasure Priority
Review'' (or ``MCMPR'').
All paper checks should be in U.S. currency from a U.S. bank made
payable and mailed to: Food and Drug Administration, P.O. Box 979107,
St. Louis, MO 63197-9000.
If checks are sent by a courier that requests a street address, the
courier can deliver the checks to: U.S. Bank, Attention: Government
Lockbox 979107, 3180 Rider Trail S, Earth City, MO 63045. (Note: This
U.S. Bank address is for courier delivery only. If you have any
questions concerning courier delivery, contact the U.S. Bank at 855-
259-3064. This telephone number is only for questions about courier
delivery.) The FDA post office box number (P.O. Box 979107) must be
written on the check. If needed, FDA's tax identification number is 53-
0196965.
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
<a href="http://Pay.gov">Pay.gov</a> 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.
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: https://
[[Page 76849]]
www.healthaffairs.org/doi/full/10.1377/hlthaff.25.2.313.
Dated: September 16, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-21433 Filed 9-18-24; 8:45 am]
BILLING CODE 4164-01-P
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