[Federal Register Volume 80, Number 177 (Monday, September 14, 2015)]
[Notices]
[Pages 55121-55123]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-23006]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-0007]


Fee for Using a Tropical Disease Priority Review Voucher in 
Fiscal Year 2016

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

[[Page 55122]]

tropical disease priority review voucher for fiscal year (FY) 2016. 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 2016.

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 qualified 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 that may then use it. 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 a 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 2016 as $2,727,000 and outlines FDA's process for 
implementing the collection of the priority review user fees. This rate 
is effective on October 1, 2015, and will remain in effect through 
September 30, 2016, 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 2016

    Under section 524(c)(2) of the FD&C Act, the amount of the tropical 
disease priority review user fee 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 by FDA in the 
review of a human drug application that is not subject to priority 
review in the previous fiscal year. The priority review voucher fee is 
intended to cover the incremental costs for FDA to do a priority review 
on a product that would otherwise get a standard review. The formula 
provides the Agency with the added resources to conduct a priority 
review while still ensuring a robust priority review voucher program 
that is consistent with the Agency's public health goal of encouraging 
the development of new drug and biological products.
    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.
    Section 524 of the FD&C Act specifies 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 2016, 
and the previous fiscal year is FY 2015. However, the FY 2015 
submission cohort has not been closed out yet, and the cost data for FY 
2015 are not complete. The latest year for which FDA has complete cost 
data is FY 2014. 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 2014, show a standard cost 
(rounded to the nearest thousand dollars) of $5,646,000 for a NME NDA 
and $5,533,000 for a BLA. Based on these standard costs, the total cost 
to review the 48 applications in these two categories in FY 2014 (30 
NME NDAs with clinical data and 18 BLAs) was $268,974,000. (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-nine of these applications (20 NDAs and 9 BLAs) received 
priority review, which would mean that the remaining 19 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. In the article 
``Developing Drugs for Developing Countries,'' published in ``Health 
Affairs,'' Volume 25, Number 2, in 2006, the comparison of historical 
average review times by David B. Ridley, Henry G. Grabowski, and 
Jeffrey L. Moe, supports a priority review multiplier in the range of 
1.48 to 2.35. The multiplier derived by FDA falls well below the 
midpoint of this range. Using FY 2014 figures, the costs of a priority 
and standard review are estimated using the following formula:

(29 [alpha] x 1.67) + (19 [alpha]) = $268,974,000

where ``[alpha]'' is the cost of a standard review and ``[alpha] x 
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 
$3,989,000 (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 
$6,662,000 (rounded to the nearest thousand dollars). The difference 
between these two cost estimates, or $2,673,000, represents the 
incremental cost of conducting a priority review rather than a standard 
review.
    For the FY 2016 fee, FDA will need to adjust the FY 2014 
incremental cost by the average amount by which FDA's average costs 
increased in the 3 years prior to FY 2015, to adjust the FY 2014 amount 
for cost increases in FY 2015. That adjustment, published in the 
Federal Register on August 3, 2015 (see 80 FR 46028 at 46029), setting 
FY 2016 PDUFA fees, is 2.0266 percent for the most recent year, not 
compounded. Increasing the FY 2014 incremental priority review cost of 
$2,673,000 by 2.0266 percent results in an estimated cost of $2,727,000 
(rounded to the nearest thousand dollars). This is the priority review 
user fee amount for FY 2016 that must be submitted with a priority 
review voucher in FY 2016, in addition to any PDUFA fee that is 
required for such an application.

III. Fee Schedule for FY 2016

    The fee rate for FY 2016 is set out in table 1:

     Table 1--Tropical Disease Priority Review Schedule for FY 2016
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                                                            Fee rate for
                       Fee category                            FY 2016
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Application submitted with a tropical disease priority       $2,727,000
 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 prior to a relevant appropriation for fees 
for that fiscal year. 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, 2015, 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 check, bank draft, or U.S. postal money 
order payable to the order of the Food and Drug Administration. 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.) 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.
    Wire transfer payments may also be used. 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: New York Federal Reserve Bank, 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., Silver Spring, MD 20993-0002.

    Dated: September 8, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-23006 Filed 9-11-15; 8:45 am]
BILLING CODE 4164-01-P