[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.
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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....
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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, 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