[Federal Register Volume 89, Number 182 (Thursday, September 19, 2024)]
[Notices]
[Pages 76846-76849]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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: 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.<SUP>3 4 5</SUP>
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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 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: 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 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: https://www.fda.gov/files/drugs/published/Expedited-Programs-for-Serious-Conditions-Drugs-and-Biologics.pdf) 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 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.
    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.

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 
Pay.gov 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 
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.

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 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://

[[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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