[Federal Register Volume 84, Number 189 (Monday, September 30, 2019)]
[Notices]
[Pages 51601-51603]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-21196]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-0007]


Fee for Using a Tropical Disease Priority Review Voucher in 
Fiscal Year 2020

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 rates for using a tropical disease priority review 
voucher for fiscal year (FY) 2020. The Federal Food, Drug, and Cosmetic 
Act (FD&C Act), as amended by the Food and Drug Administration 
Amendments Act of 2007 (FDAAA), authorizes FDA to determine and collect 
priority review user fees for certain applications for review of drug 
and biological products when those applications use a tropical disease 
priority review voucher. These vouchers are awarded to the sponsors of 
certain tropical disease product applications, submitted after 
September 27, 2007, upon FDA approval of such applications. The amount 
of the fee submitted to FDA with applications using a tropical disease 
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 tropical disease priority review fee rate for FY 
2020.

FOR FURTHER INFORMATION CONTACT: Melissa Hurley, Office of Financial 
Management, Food and Drug Administration, 4041 Powder Mill Rd., Rm. 
61075, Beltsville, MD 20705-4304, 240-402-4585.

SUPPLEMENTARY INFORMATION:

I. Background

    Section 1102 of FDAAA (Pub. L. 110-85) added section 524 to the 
FD&C Act (21 U.S.C. 360n). In section 524, Congress encouraged 
development of new 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, the sponsor 
of an eligible human drug application submitted after September 27, 
2007, 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 (assuming other criteria are met). 
The recipient of a tropical disease priority review voucher may either 
use the voucher with a future submission 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), or transfer (including by sale) the 
voucher to another party. The voucher may be transferred (including by 
sale) 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 upon the 
type of application. Information regarding the PDUFA goals is available 
at: https://www.fda.gov/downloads/forindustry/userfees/prescriptiondruguserfee/ucm511438.pdf.
    The sponsor that uses a priority review voucher is entitled to a 
priority review but must pay FDA a priority review user fee in addition 
to any other fee required by PDUFA. FDA published guidance on its 
website about how this tropical disease priority review voucher program 
operates (available at: https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm080599.pdf).
    This notice establishes the tropical disease priority review fee 
rate for FY 2020 as $2,167,116 and outlines FDA's process for 
implementing the collection of the priority review user fees. This rate 
is effective on October 1, 2019, and will remain in effect through 
September 30, 2020, for applications submitted with a tropical disease 
priority review voucher. The payment of this priority review user fee 
is required in addition to the payment of any other fee that would 
normally apply to such an application under PDUFA before FDA will 
consider the application complete and acceptable for filing.

[[Page 51602]]

II. Tropical Disease Priority Review User Fee for FY 2020

    FDA interprets section 524(c)(2) of the FD&C Act as requiring that 
FDA determine the amount of the tropical disease 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. Under 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 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. Under the PDUFA goals letter, 
FDA 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 fees for FY 2020, which is to be based on standard 
cost data from the previous fiscal year, FY 2019. However, the FY 2019 
submission cohort has not been closed out yet, thus the cost data for 
FY 2019 are not complete. The latest year for which FDA has complete 
cost data is FY 2018. 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) 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 2018 was $335,338,639. There was a total of 74 applications 
in these two categories (53 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, 48 (35 NDAs and 13 BLAs) received 
priority review and the remaining 26 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 2018 figures, the costs of a 
priority and standard review are estimated using the following formula:

(48 [alpha] x 1.67) + (26 [alpha]) = $335,338,639

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 $3,158,804 (rounded to the nearest dollar) and 
the cost of a priority review for NME NDAs and BLAs is 1.67 times that 
amount, or $5,275,203 (rounded to the nearest dollar). The difference 
between these two cost estimates, or $2,116,399, represents the 
incremental cost of conducting a priority review rather than a standard 
review.
    For the FY 2020 fee, FDA will need to adjust the FY 2018 
incremental cost by the average amount by which FDA's average costs 
increased in the 3 years prior to FY 2019, to adjust the FY 2018 amount 
for cost increases in FY 2019. That adjustment, published in the 
Federal Register on August 2, 2019 (84 FR 37882), setting FY 2020 PDUFA 
fees, is 2.3964 percent for the most recent year, not compounded. 
Increasing the FY 2018 incremental priority review cost of $2,116,399 
by 2.3964 percent (or 0.023964) results in an estimated cost of 
$2,167,116 (rounded to the nearest dollar). This is the tropical 
disease priority review user fee amount for FY 2020 that must be 
submitted with a priority review voucher for a human drug application 
in FY 2020, in addition to any PDUFA fee that is required for such an 
application.

III. Fee Schedule for FY 2020

    The fee rate for FY 2020 is set out in table 1:

     Table 1--Tropical Disease Priority Review Schedule for FY 2020
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                                                         Fee rate for FY
                      Fee category                             2020
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Application submitted with a tropical disease priority       $2,167,116
 review voucher in addition to the normal PDUFA fee....
------------------------------------------------------------------------

IV. Implementation of Tropical Disease Priority Review User Fee

    Under section 524(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 524(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, FDA may 
not grant a waiver, exemption, reduction, or refund of any fees due and 
payable under section 524 of the FD&C Act (see section 524(c)(4)(C)), 
and FDA may not collect priority review voucher fees ``except to the 
extent provided in advance in appropriation Acts.'' (Section 
524(c)(5)(B) of the FD&C Act.)
    The tropical disease priority review fee established in the new fee 
schedule must be paid for any application that is received on or after 
October 1, 2019, and submitted with a priority review voucher. This fee 
must be paid in addition to any other fee due under PDUFA. Payment 
should 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

[[Page 51603]]

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 should 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.
    If paying by paper check, the user fee ID number should be included 
on the check, followed by the words ``Tropical Disease Priority 
Review.'' 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.
    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 with the Dockets Management 
Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 
1061, Rockville, MD 20852, 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 25, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-21196 Filed 9-27-19; 8:45 am]
BILLING CODE 4164-01-P