[Federal Register Volume 85, Number 195 (Wednesday, October 7, 2020)]
[Notices]
[Pages 63282-63284]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-22192]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-1987]


Fee Rate for Using a Material Threat Medical Countermeasure 
Priority Review Voucher in Fiscal Year 2021

AGENCY: Food and Drug Administration, Health and Human Services (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 material threat medical 
countermeasure (MCM) priority review voucher for fiscal year (FY) 2021. 
The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the 
21st Century Cures Act (Cures Act), authorizes FDA to determine and 
collect material threat MCM priority review user fees for certain 
applications for review of human drug products when those applications 
use a material threat MCM priority review voucher. These vouchers are 
awarded to the sponsors of material threat MCM applications that meet 
all the requirements of this program and upon FDA approval of such 
applications. The amount of the fee for using a material threat MCM 
priority review voucher is determined each FY based on the difference 
between the average cost incurred by FDA to review a human drug 
application designated as priority review in the previous FY, and the 
average cost incurred in the review of an application that is not 
subject to priority review in the previous FY. This notice establishes 
the material threat MCM priority review fee rate for FY 2021 and 
outlines the payment procedures for such fees.

FOR FURTHER INFORMATION CONTACT: Lola Olajide, Office of Financial 
Management, Food and Drug Administration, 4041 Powder Mill Rd., Rm. 
61077B, Beltsville, MD 20705-4304, 240-402-4244.

SUPPLEMENTARY INFORMATION:

I. Background

    Section 3086 of the 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. The recipient of a material threat MCM 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. 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 PDUFA goals is available at

[[Page 63283]]

https://www.fda.gov/media/99140/download.
    The sponsor that uses a material threat MCM priority review voucher 
is entitled to a priority review of its eligible human drug 
application, but must pay FDA a material threat MCM priority review 
user fee in addition to any user fee required by PDUFA for the 
application. 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.
    This notice establishes the material threat MCM priority review fee 
rate for FY 2021 at $1,360,879 and outlines FDA's payment procedures 
for material threat MCM priority review user fees. This rate is 
effective on October 1, 2020, and will remain in effect through 
September 30, 2021.

II. Material Threat Medical Countermeasure Priority Review User Fee 
Rate for FY 2021

    FDA interprets section 565A(c)(2) of the FD&C Act as requiring that 
FDA determine the amount of the material threat MCM priority review 
user fee 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 with a PDUFA goal date of 6 
months after the receipt or filing date, depending on the type of 
application. As described in the PDUFA goals letter, FDA has committed 
to reviewing and acting on 90 percent of the applications granted 
priority review status within this expedited timeframe. Normally, an 
application for a human drug 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. As described in the PDUFA goals 
letter, FDA has committed to reviewing and acting on 90 percent of 
standard applications within 10 months of the receipt or filing date, 
depending on the type of application. 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 2021, which is to be based on standard 
cost data from the previous fiscal year, FY 2020. However, the FY 2020 
submission cohort has not been closed out yet, thus the cost data for 
FY 2020 are not complete. The latest year for which FDA has complete 
cost data is FY 2019. 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 that for which FDA tracks the cost of review are: 
(1) New drug applications (NDAs) for a new molecular entity (NME) with 
clinical data and (2) biologics license applications (BLAs).
    The total cost for FDA to review NME NDAs with clinical data and 
BLAs in FY 2019 was $199,369,923. There was a total of 70 applications 
in these two categories (49 NME NDAs with clinical data and 21 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 (32 NDAs and 12 BLAs) received 
priority review and the remaining 26 (17 NDAs and 9 BLAs) received 
standard reviews. Because a priority review compresses a review 
schedule that ordinarily takes 10 months into 6 months, FDA estimates 
that a multiplier of 1.67 (10 months / 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 2019 figures, the costs of a priority and standard review are 
estimated using the following formula:
(44 [alpha] x 1.67) + (26 [alpha]) = $199,369,923

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 $2,004,121 (rounded to the nearest dollar) and the cost of a 
priority review for NME NDAs and BLAs is 1.67 times that amount, or 
$3,346,882 (rounded to the nearest dollar). The difference between 
these two cost estimates, or $1,342,761, represents the incremental 
cost of conducting a priority review rather than a standard review.

    For the FY 2021 fee, FDA will need to adjust the FY 2019 
incremental cost by the average amount by which FDA's average costs 
increased in the 3 years prior to FY 2020, to adjust the FY 2019 amount 
for cost increases in FY 2020. That adjustment, published in the 
Federal Register on August 3, 2020 (see 85 FR 46651), setting FY 2021 
PDUFA fees, is 1.3493 percent for the most recent year, not compounded. 
Increasing the FY 2019 incremental priority review cost of $1,342,761 
by 1.3493 percent (or 0.013493) results in an estimated cost of 
$1,360,879 (rounded to the nearest dollar). This is the material threat 
MCM priority review user fee amount for FY 2021 that must be submitted 
with a priority review voucher for a human drug application in FY 2021, 
in addition to any PDUFA fee that is required for such an application.

III. Fee Rate Schedule for FY 2021

    The fee rate for FY 2021 is set out in table 1:

Table 1--Material Threat Medical Countermeasure Priority Review Schedule
                               for FY 2021
------------------------------------------------------------------------
                                                         Priority review
                      Fee category                       fee rate for FY
                                                               2021
------------------------------------------------------------------------
Application submitted with a material threat MCM             $1,360,879
 priority review voucher in addition to the normal
 PDUFA fee.............................................
------------------------------------------------------------------------

IV. Implementation of Material Threat Medical Countermeasure Priority 
Review User Fee

    Under section 565A(c)(4)(A) of the FD&C Act, the priority review 
user fee is due upon submission of a human drug application for which 
the priority review voucher is used. Section 565A(c)(4)(B) of the FD&C 
Act specifies that the application 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, section 
565A(c)(4)(C) specifies that FDA may not grant a waiver, exemption, 
reduction, or refund of any fees due and

[[Page 63284]]

payable under this section of the FD&C Act.
    The material threat MCM priority review fee established in the new 
fee schedule must be paid for any application with a priority review 
voucher that is received on or after October 1, 2020. This fee must be 
paid in addition to any other fee due under PDUFA. 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 ID number is generated.
    If paying by paper check, the user fee identification (ID) number 
should be included on the check, followed by the words ``Material 
Threat Medical Countermeasure Priority Review.'' All paper checks must 
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.
    If paying by wire transfer, please reference your unique user fee 
ID number when completing your transfer. 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.

V. Reference

    The following reference is on display at 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: October 2, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-22192 Filed 10-2-20; 4:15 pm]
BILLING CODE 4164-01-P