[Federal Register Volume 83, Number 186 (Tuesday, September 25, 2018)]
[Notices]
[Pages 48437-48439]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-20772]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-0007]


Fee for Using a Tropical Disease Priority Review Voucher in 
Fiscal Year 2019

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) 2019. 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 
or biological products when those applications use a tropical disease 
priority review voucher. These vouchers are awarded to the applicants 
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 
2019.

FOR FURTHER INFORMATION CONTACT: 
Lola Olajide, Office of Financial Management, Food and Drug 
Administration, 8455 Colesville Rd., COLE-14541B, Silver Spring, MD 
20993-0002, 240-402-4244.

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 
applicant 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 applicant 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 2019 as $2,457,140 and outlines FDA's process for 
implementing the collection of the priority review user fees. This rate 
is effective on October 1, 2018, and will remain in effect through 
September 30, 2019, 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.

II. Tropical Disease Priority Review User Fee for FY 2019

    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

[[Page 48438]]

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 2019, and the previous fiscal year is FY 
2018. However, the FY 2018 submission cohort has not been closed out 
yet, and the cost data for FY 2018 are not complete. The latest year 
for which FDA has complete cost data is FY 2017. 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. FDA uses data that the 
Agency estimates and publishes on its website each year--standard costs 
for review. FDA does not publish a standard cost for ``the review of a 
human drug application subject to priority review in the previous 
fiscal year.'' However, we expect all such applications would contain 
clinical data. The standard cost application categories with clinical 
data that FDA does publish each year are: (1) New drug applications 
(NDAs) for a new molecular entity (NME) with clinical data and (2) 
biologics license applications (BLAs).
    The worksheets for standard costs for FY 2017 show a standard cost 
of $5,340,560 for an NME NDA and $4,596,936 for a BLA. Based on these 
standard costs, the total cost to review the 57 applications in these 
two categories in FY 2017 (31 NME NDAs with clinical data and 26 BLAs) 
was $285,077,688. (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 33 (20 NDAs 
and 13 BLAs) received priority review, which would mean that the 
remaining 24 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 2017 figures, the costs of a priority and standard 
review are estimated using the following formula:

(33 [alpha] x 1.67) + (24 [alpha]) = $285,077,688

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 
$3,603,561 (rounded to the nearest dollar) and the cost of a priority 
review for NME NDAs and BLAs is 1.67 times that amount, or $6,017,946 
(rounded to the nearest dollar). The difference between these two cost 
estimates, or $2,414,386, represents the incremental cost of conducting 
a priority review rather than a standard review.
    For the FY 2019 fee, FDA will need to adjust the FY 2017 
incremental cost by the average amount by which FDA's average costs 
increased in the 3 years prior to FY 2018, to adjust the FY 2017 amount 
for cost increases in FY 2018. That adjustment, published in the 
Federal Register on August 1, 2018 (83 FR 37504), setting FY 2019 PDUFA 
fees, is 1.7708 percent for the most recent year, not compounded. 
Increasing the FY 2017 incremental priority review cost of $2,414,386 
by 1.7708 percent (or 0.017708) results in an estimated cost of 
$2,457,140 (rounded to the nearest dollar). This is the tropical 
disease priority review user fee amount for FY 2019 that must be 
submitted with a priority review voucher for a human drug application 
in FY 2019, in addition to any PDUFA fee that is required for such an 
application.

III. Fee Schedule for FY 2019

    The fee rate for FY 2019 is set out in table 1:

     Table 1--Tropical Disease Priority Review Schedule for FY 2019
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                                                         Fee rate for FY
                      Fee category                             2019
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Application submitted with a tropical disease priority       $2,457,140
 review voucher in addition to the normal PDUFA fee....
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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, 2018, 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 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 with a 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

[[Page 48439]]

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 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://faculty.fuqua.duke.edu/~willm/
HSM_RA/Documents/HA2006_Ridley_Vouchers.pdf.

    Dated: September 19, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-20772 Filed 9-24-18; 8:45 am]
 BILLING CODE 4164-01-P