[Federal Register Volume 82, Number 187 (Thursday, September 28, 2017)]
[Notices]
[Pages 45296-45298]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-20799]
[[Page 45296]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2017-N-0007]
Fee for Using a Tropical Disease Priority Review Voucher in
Fiscal Year 2018
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) 2018. The Federal Food, Drug, and Cosmetic
Act (the 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 approval of drug
or biological products when those applications use a tropical disease
priority review voucher awarded by the Secretary of Health and Human
Services. 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 in the review of a human drug
application subject to 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 2018.
FOR FURTHER INFORMATION CONTACT: Robert J. Marcarelli, Office of
Financial Management, Food and Drug Administration, 8455 Colesville
Rd., COLE-14202F, Silver Spring, MD 20993-0002, 301-796-7223.
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 certain 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. 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 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: http://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 Web
site about how this tropical disease priority review voucher program
operates (available at: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm080599.pdf).
This notice establishes the tropical disease priority review fee
rate for FY 2018 as $2,830,579 and outlines FDA's process for
implementing the collection of the priority review user fees. This rate
is effective on October 1, 2017, and will remain in effect through
September 30, 2018, 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 2018
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 will receive 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 2018, and the previous fiscal year is FY
2017. However, the FY 2017 submission cohort has not been closed out
yet, and the cost data for FY 2017 are not complete. The latest year
for which FDA has complete cost data is FY 2016. 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 Web site 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 2016, show a standard cost
(rounded to the nearest hundred dollars) of $5,929,100 for a NME NDA
and $4,887,100 for a BLA. Based on these standard costs, the total cost
to review the 49 applications in these two categories in FY 2016 (27
NME NDAs with clinical data and 22 BLAs) was $267,601,900. (Note: These
numbers exclude the President's Emergency Plan for AIDS Relief NDAs; no
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investigational new drug review costs are included in this amount.)
Twenty-three of these applications (14 NDAs and 9 BLAs) received
priority review, which would mean that 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 2016 figures, the costs of a priority and standard review are
estimated using the following formula:
(23 [alpha] x 1.67) + (26 [alpha]) = $267,601,900
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
$4,154,664 (rounded to the nearest dollar) and the cost of a priority
review for NME NDAs and BLAs is 1.67 times that amount, or $6,938,289
(rounded to the nearest dollar). The difference between these two cost
estimates, or $2,783,625, represents the incremental cost of conducting
a priority review rather than a standard review.
For the FY 2018 fee, FDA will need to adjust the FY 2016
incremental cost by the average amount by which FDA's average costs
increased in the 3 years prior to FY 2017, to adjust the FY 2016 amount
for cost increases in FY 2017. That adjustment, published in the
Federal Register on July 28, 2016 (see 81 FR 49674 at 49676), setting
FY 2018 PDUFA fees, is 1.6868 percent for the most recent year, not
compounded. Increasing the FY 2016 incremental priority review cost of
$2,783,625 by 1.6868 percent (or 0.016868) results in an estimated cost
of $2,830,579 (rounded to the nearest dollar). This is the tropical
disease priority review user fee amount for FY 2018 that must be
submitted with a priority review voucher for a human drug application
in FY 2018, in addition to any PDUFA fee that is required for such an
application.
III. Fee Schedule for FY 2018
The fee rate for FY 2018 is set out in table 1:
Table 1--Tropical Disease Priority Review Schedule for FY 2018
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Fee rate for FY
Fee category 2018
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Application submitted with a tropical disease priority $2,830,579
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.) Beginning with FDA's appropriation for
FY 2009, the annual appropriation language states specifically that
``priority review user fees authorized by 21 U.S.C. 360n [i.e., section
524 of the FD&C Act] may be credited to this account, to remain
available until expended.'' (Pub. L. 111-8, Section 5, Division A,
Title VI).
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, 2017, 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 Web site after the
user fee ID number is generated.
If paying with a paper check the user fee identification (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 Treasury, TREAS NYC,
33 Liberty St., New York, NY 10045, Account Number: 75060099, Routing
Number: 021030004, SWIFT: FRNYUS33, Beneficiary: FDA, 8455 Colesville
Rd., 14th Floor, Silver Spring, MD 20993-0002.
V. Reference
The following reference is on display in the Dockets Management
Staff (HFA-305), Food and Drug Administration,
[[Page 45298]]
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.
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.
Dated: September 22, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-20799 Filed 9-27-17; 8:45 am]
BILLING CODE 4164-01-P