Federal Register / Vol. 88, No. 188 / Friday, September 29, 2023 / Notices 67305 

1Although 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. 

2 Information regarding the tropical disease 

priority review voucher program is available at: 

https://www.fda.gov/regulatory-information/searchfda-guidance-documents/tropical-disease-priorityreview-vouchers. 

3 Information regarding the rare pediatric disease 

priority review voucher program, visit: https://

www.fda.gov/Drugs/DevelopmentApprovalProcess/

DevelopmentResources/ucm375479.htm. 

4 Information regarding the material threat MCM 

priority review voucher program is available at: 

https://www.fda.gov/emergency-preparedness-andresponse/mcm-legal-regulatory-and-policyframework/21st-century-cures-act-mcm-relatedcures-provisions. 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2023–N–3999] 

Fee Rate for Using a Priority Review 

Voucher in Fiscal Year 2024 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

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) 2024. 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 

2024 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, 2023, and will remain in effect 

through September 30, 2024. 

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 OO-OFBAP-OFM-UFSSGovernment@fda.hhs.gov. 

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). 

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.1

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 2024 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.234

This notice establishes the FY 2024 

priority review fee rate for use of 

tropical disease, rare pediatric disease, 

and material threat MCM priority 

review vouchers at $1,314,206 and 

outlines FDA’s process for 

implementing the collection of priority 

review user fees. This rate is effective on 

October 1, 2023, and will remain in 

effect through September 30, 2024. 

II. Priority Review User Fee Rate for FY 

2024 

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 


lotter on DSK11XQN23PROD with NOTICES1
67306 Federal Register / Vol. 88, No. 188 / Friday, September 29, 2023 / Notices 

5Additional 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/ 

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 2024, 

which is to be based on standard cost 

data from the previous fiscal year, FY 

2023. However, the FY 2023 submission 

cohort has not been closed out yet, thus 

the cost data for FY 2023 are not 

complete. The latest year for which FDA 

has complete cost data is FY 2022. 

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 

2022 was $208,593,080. There was a 

total of 81 applications in these two 

categories (41 NME NDAs with clinical 

data and 40 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, 44 (19 NDAs and 25 

BLAs) received priority review and the 

remaining 37 (22 NDAs and 15 BLAs) 

received standard reviews. Because a 

priority review compresses a review that 

ordinarily takes 10 months into 6 

months, FDA estimates that a multiplier 

of 1.67 (10 months divided by 6 months) 

should be applied to nonpriority review 

costs in estimating the effort and cost of 

a priority review as compared to a 

standard review. This multiplier is 

consistent with published research on 

this subject, which supports a priority 

review multiplier in the range of 1.48 to 

2.35 (Ref. 1). Using FY 2022 figures, the 

costs of a priority and standard review 

are estimated using the following 

formula: 

(44 a × 1.67) + (37 a) = $208,593,080 

where ‘‘a’’ is the cost of a standard 

review and ‘‘a 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 

$1,888,062 (rounded to the nearest 

dollar) and the cost of a priority review 

for NME NDAs and BLAs is 1.67 times 

that amount, or $3,153,064 (rounded to 

the nearest dollar). The difference 

between these two cost estimates, or 

$1,265,002, represents the incremental 

cost of conducting a priority review 

rather than a standard review. 

For the FY 2024 fee, FDA will need 

to adjust the FY 2022 incremental cost 

by the average amount by which FDA’s 

average costs increased in the 3 years 

prior to FY 2023, to adjust the FY 2022 

amount for cost increases in FY 2023. 

That adjustment, published in the 

Federal Register setting the FY 2024 

PDUFA fees, is 3.8896 percent for the 

most recent year, not compounded. 

Increasing the FY 2022 incremental 

priority review cost of $1,265,002 by 

3.8896 percent (or 0.038896) results in 

an estimated cost of $1,314,206 

(rounded to the nearest dollar). This is 

the priority review user fee amount for 

FY 2024 that must be submitted with a 

priority review voucher for a human 

drug application in FY 2024, in addition 

to any PDUFA fee that is required for 

such an application. 

III. Fee Rate Schedule for FY 2024 

The fee rate for FY 2024 is set in table 

1: 

TABLE 1—PRIORITY REVIEW FEE SCHEDULE FOR FY 2024 

Fee category Priority review fee 

rate for FY 2024 

Application submitted with a tropical disease priority review voucher in addition to the normal PDUFA fee ........................ $1,314,206 

Application submitted with a rare pediatric disease priority review voucher in addition to the normal PDUFA fee .............. 1,314,206 

Application submitted with a material threat MCM priority review voucher in addition to the normal PDUFA fee ................ 1,314,206 

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, 2023, 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.5


lotter on DSK11XQN23PROD with NOTICES1
Federal Register / Vol. 88, No. 188 / Friday, September 29, 2023 / Notices 67307 

GuidanceComplianceRegulatoryInformation/ 

Guidances/default.htm. 

6 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-forSerious-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. 

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.6

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 the 

FDA. The invoice number is issued by 

the 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, 

1005 Convention Plaza, St. Louis, MO 

63101. Please note that this address is 

valid only until October 5, 2023. 

Beginning October 6, 2023, all checks 

sent by courier must be mailed 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 800–495–4981. 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 the 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:// 

www.healthaffairs.org/doi/full/10.1377/

hlthaff.25.2.313. 

Dated: September 26, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–21513 Filed 9–28–23; 8:45 am] 

BILLING CODE 4164–01–P 


lotter on DSK11XQN23PROD with NOTICES1