[Federal Register Volume 81, Number 190 (Friday, September 30, 2016)]
[Notices]
[Pages 67356-67358]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-23623]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-0007]


Fee for Using a Tropical Disease Priority Review Voucher in 
Fiscal Year 2017

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) 2017. 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 2017.

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

[[Page 67357]]

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/ucm270412.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 draft 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 2017 as $2,706,000 and outlines FDA's process for 
implementing the collection of the priority review user fees. This rate 
is effective on October 1, 2016, and will remain in effect through 
September 30, 2017, 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 2017

    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.
    As interpreted by FDA, section 524(c)(2) of the FD&C Act requires 
that the fee amount should be based on the difference between the 
average cost incurred by the Agency in the review of a human drug 
application subject to a 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. FDA is setting fees for FY 2017, and the previous fiscal 
year is FY 2016. However, the FY 2016 submission cohort has not been 
closed out yet, and the cost data for FY 2016 are not complete. The 
latest year for which FDA has complete cost data is FY 2015. 
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 2015, show a standard cost 
(rounded to the nearest thousand dollars) of $5,251,000 for a NME NDA 
and $5,055,000 for a BLA. Based on these standard costs, the total cost 
to review the 56 applications in these two categories in FY 2015 (32 
NME NDAs with clinical data and 24 BLAs) was $289,352,000. (Note: These 
numbers exclude the President's Emergency Plan for AIDS Relief NDAs; no 
investigational new drug review costs are included in this amount.) 25 
of these applications (18 NDAs and 7 BLAs) received priority review, 
which would mean that the remaining 31 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 2015 
figures, the costs of a priority and standard review are estimated 
using the following formula:

(25 [alpha] x 1.67) + (31 [alpha]) = $289,352,000

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 
$3,977,000 (rounded to the nearest thousand dollars) and the cost of a 
priority review for NME NDAs and BLAs is 1.67 times that amount, or 
$6,642,000 (rounded to the nearest thousand dollars). The difference 
between these two cost estimates, or $2,665,000, represents the 
incremental cost of conducting a priority review rather than a standard 
review.
    For the FY 2017 fee, FDA will need to adjust the FY 2015 
incremental cost by the average amount by which FDA's average costs 
increased in the three years prior to FY 2016, to adjust the FY 2015 
amount for cost increases in FY 2016. That adjustment, published in the 
Federal Register on July 28, 2016 (see 81 FR 49674 at 49676), setting 
FY 2017 PDUFA fees, is 1.5468 percent for the most recent year, not 
compounded. Increasing the FY 2015 incremental priority review cost of 
$2,665,000 by 1.5468 percent results in an estimated cost of $2,706,000 
(rounded to the nearest thousand dollars). This is the

[[Page 67358]]

tropical disease priority review user fee amount for FY 2017 that must 
be submitted with a priority review voucher for a human drug 
application in FY 2017, in addition to any PDUFA fee that is required 
for such an application.

III. Fee Schedule for FY 2017

    The fee rate for FY 2017 is set out in Table 1:

     Table 1--Tropical Disease Priority Review Schedule for FY 2017
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                                                         Fee rate for FY
                      Fee category                             2017
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Application submitted with a tropical disease priority       $2,706,000
 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 this section of the FD&C Act and FDA may not collect 
priority review voucher fees ``except to the extent provided in advance 
in appropriation Acts.'' Section 524(c)(4)(C) and 524(c)(5)(B). 
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 (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, 2016, and submitted with a priority review voucher. 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. Once you 
search for your invoice, click ``Pay Now'' to be redirected to Pay.gov. 
Note that electronic payment options are based on the balance due. 
Payments must be drawn on U.S bank accounts.
    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.
    The user fee identification (ID) number should be included on the 
check, followed by the words ``Tropical Disease Priority Review.'' 
Payments can be 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. The tax identification number of FDA 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. Please ask your financial 
institution about the fee and include it with your payment to ensure 
that your fee is fully paid. 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.
    Paying by credit card (Discover, VISA, MasterCard, American 
Express) is available for balances less than $25,000. If the balance 
exceeds this amount, only the ACH option is available. Payments must be 
drawn on U.S. credit cards.

V. Reference

    The following reference is on display in the Division of Dockets 
Management (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.

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 26, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-23623 Filed 9-29-16; 8:45 am]
 BILLING CODE 4164-01-P