Notice2022-21969
Fee Rate for Using a Priority Review Voucher in Fiscal Year 2023
Primary source
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Published
October 7, 2022
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) 2023. 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 2023 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. This rate is effective on October 1, 2022, and will remain in effect through September 30, 2023.
Full Text
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<title>Federal Register, Volume 87 Issue 194 (Friday, October 7, 2022)</title>
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[Federal Register Volume 87, Number 194 (Friday, October 7, 2022)]
[Notices]
[Pages 61050-61052]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-21969]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2022-N-2392]
Fee Rate for Using a Priority Review Voucher in Fiscal Year 2023
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) 2023. 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 2023 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. This rate is effective on October 1,
2022, and will remain in effect through September 30, 2023.
FOR FURTHER INFORMATION CONTACT: Robert Marcarelli, Office of Financial
Management, Food and Drug Administration, 4041 Powder Mill Rd., Rm.
61075, Beltsville, MD 20705-4304, 301-796-7223 and the User Fees
Support Staff at <a href="/cdn-cgi/l/email-protection#b8f7f795f7fefaf9e895f7fef595edfeebeb95ffd7ceddcad6d5ddd6ccf8dedcd996d0d0cb96dfd7ce"><span class="__cf_email__" data-cfemail="8ac5c5a7c5ccc8cbdaa7c5ccc7a7dfccd9d9a7cde5fceff8e4e7efe4fecaeceeeba4e2e2f9a4ede5fc">[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 (FDAAA) (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 (FDASIA) (Pub. L. 112-144) added section 529 to 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)) 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).
C. Establishment of the Material Threat MCM Priority Voucher
Section 3086 of the 21st Century Cures Act (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.
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 (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 Public Health Service 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 2023 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>1 2 3</SUP>
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\1\ 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>.
\2\ Information regarding the rare pediatric disease priority
review voucher program, visit: <a href="https://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/ucm375479.htm">https://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/ucm375479.htm</a>.
\3\ 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 2023 priority review fee rate for
use of tropical disease, rare pediatric disease, and material threat
MCM priority review vouchers at $1,524,039 and outlines FDA's process
for implementing the collection of priority review user fees. This rate
is effective on October 1, 2022, and will remain in effect through
September 30, 2023.
II. Priority Review User Fee Rate for FY 2023
FDA interprets sections 524(c)(2) (tropical disease priority review
user fee), 529(c)(2) (rare pediatric disease priority review user fee),
and 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
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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 time frame
prescribed in FDA commitments for such reviews made in connection with
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 applications
(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 2023, which is to be based on standard
cost data from the previous fiscal year, FY 2022. However, the FY 2022
submission cohort has not been closed out yet, thus the cost data for
FY 2022 are not complete. The latest year for which FDA has complete
cost data is FY 2021. 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 2021 was $240,559,727. There was a total of 76 applications
in these two categories (41 NME NDAs with clinical data and 35 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 47 (27 NDAs and 20 BLAs) received
priority review and the remaining 29 (14 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
non-priority 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 2021 figures, the costs of a priority and standard review are
estimated using the following formula:
(47 [alpha] x 1.67) + (29 [alpha]) = $240,559,727
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
$2,237,973 (rounded to the nearest dollar) and the cost of a priority
review for NME NDAs and BLAs is 1.67 times that amount, or $3,737,415
(rounded to the nearest dollar). The difference between these two cost
estimates, or $1,499,442, represents the incremental cost of conducting
a priority review rather than a standard review.
For the FY 2023 fee, FDA will need to adjust the FY 2021
incremental cost by the average amount by which FDA's average costs
increased in the 3 years prior to FY 2022, to adjust the FY 2021amount
for cost increases in FY 2022. That adjustment, published in the
Federal Register setting the FY 2023 PDUFA fees, is 1.6404 percent for
the most recent year, not compounded. Increasing the FY 2021
incremental priority review cost of $1,499,442 by 1.6404 percent (or
0.016404) results in an estimated cost of $1,524,039 (rounded to the
nearest dollar). This is the priority review user fee amount for FY
2023 that must be submitted with a priority review voucher for a human
drug application in FY 2023, in addition to any PDUFA fee that is
required for such an application.
III. Fee Rate Schedule for FY 2023
The fee rate for FY 2023 is set in table 1:
Table 1--Priority Review Fee Schedule for FY 2023
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Priority review
Fee category fee rate for FY
2023
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Application submitted with a tropical disease $1,524,039
priority review voucher in addition to the normal
PDUFA fee...........................................
Application submitted with a rare pediatric disease 1,524,039
priority review voucher in addition to the normal
PDUFA fee...........................................
Application submitted with a material threat MCM 1,524,039
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, 2022,
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 timely payment of PDUFA user fees generally,
please see section 736(a)(2)(A) of the FD&C Act.
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
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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.\4\
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\4\ In the case of ``rolling review'' of an application (as
discussed in May 2014 ``expedited programs'' guidance) for which a
tropical disease 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 the FDA. The invoice number is issued by the FDA upon receipt
of the rare pediatric 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.
<bullet> 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''.
<bullet> 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''.
<bullet> 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 ``MCMPRV'').
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, 1005 Convention Plaza, St. Louis, MO 63101. (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 314-
418-4013. 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 priority review, please use your invoice number issued by the
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: <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>.
Dated: October 4, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-21969 Filed 10-5-22; 11:15 am]
BILLING CODE 4164-01-P
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