[Federal Register Volume 79, Number 166 (Wednesday, August 27, 2014)]
[Notices]
[Pages 51179-51180]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-20360]



[[Page 51179]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-0007]


Fee for Using a Tropical Disease Priority Review Voucher in 
Fiscal Year 2015

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) 2015. 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 FY based on the average cost incurred 
by FDA in the review of a human drug application subject to priority 
review in the previous FY. This notice establishes the tropical disease 
priority review fee rate for FY 2015.

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 filing date.
    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 2015 as $2,562,000 and outlines FDA's process for 
implementing the collection of the priority review user fees. This rate 
is effective on October 1, 2014, and will remain in effect through 
September 30, 2015, 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 2015

    Under section 524(c)(2) of the FD&C Act, the amount of the tropical 
disease priority review user fee is determined each FY based on the 
average cost incurred by FDA in the review of a human drug application 
subject to priority review in the previous FY. 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 filing date. Normally, an application for a Center for 
Drug Evaluation and Research product will qualify for a priority review 
if FDA determines that the product, if approved, provides a safe and 
effective therapy where no satisfactory alternative therapy exists or 
is a significant improvement compared to marketed products, including 
non-drug products and/or therapies, in the treatment, diagnosis, or 
prevention of a disease. A Center for Biologics Evaluation and Research 
product will qualify for a priority review if FDA determines that the 
product, if approved, is a significant improvement in the safety or 
effectiveness of the treatment, diagnosis, or prevention of a serious 
or life-threatening disease. FDA committed to review and act on 90 
percent of the applications granted priority review status no later 
than 6 months after the filing date. An application that does not 
receive a priority designation will receive a standard review. Under 
the goals identified in the letters referenced in section 101(b) of the 
Food and Drug Administration Safety and Innovation Act (Pub. L. 112-
144), FDA commits to reviewing and acting on 90 percent of standard 
applications within 10 months of the date of filing. 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 average cost incurred by the Agency in the review of a 
human drug application subject to a priority review in the previous FY. 
FDA is setting fees for FY 2015, and the previous fiscal year is FY 
2014. However, the FY 2014 submission cohort has not been closed out 
yet, and the cost data for FY 2014 are not complete. The latest year 
for which FDA has complete cost data is FY 2013. 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 2013, the latest year for 
which standard cost data are available, show a

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standard cost (rounded to the nearest thousand dollars) of $5,122,000 
for a NME NDA and $4,090,000 for a BLA. Based on these standard costs, 
the total cost to review the 53 applications in these two categories in 
FY 2013 (31 NME NDAs with clinical data and 22 BLAs) was $248,762,000. 
(Note: These numbers exclude the President's Emergency Plan for AIDS 
Relief NDAs; no investigational new drug review costs are included in 
this amount.) Twenty of these applications (12 NDAs and 8 BLAs) 
received priority review, which would mean that the remaining 33 
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 2013 figures, the costs of a priority 
and standard review are estimated using the following formula:

(20 [alpha] x 1.67) + (33 [alpha]) = $248,762,000

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 
$3,746,000 (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 
$6,256,000 (rounded to the nearest thousand dollars). The difference 
between these two cost estimates, or $2,510,000, represents the 
incremental cost of conducting a priority review rather than a standard 
review.
    For FY 2015 fee, FDA will need to adjust the FY 2013 incremental 
cost by the average amount by which FDA's average costs increased in 
the 3 years prior to FY 2014, to adjust the FY 2013 amount for cost 
increases in FY 2014. That adjustment, published in the Federal 
Register on August 1, 2014 (see 79 FR 44807 at 44809), setting FY 2015 
PDUFA fees, is 2.0813 percent for the most recent year, not compounded. 
Increasing the FY 2013 incremental priority review cost of $2,510,000 
by 2.0813 percent results in an estimated cost of $2,562,000 (rounded 
to the nearest thousand dollars). This is the priority review user fee 
amount for FY 2015 that must be submitted with a priority review 
voucher in FY 2015, in addition to any PDUFA fee that is required for 
such an application.

III. Priority Review Fee Schedule for FY 2015

    The fee rate for FY 2015 is set out in table 1:

     Table 1--Tropical Disease Priority Review Schedule for FY 2015
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                 Fee category                     Fee rate for FY 2015
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Application submitted with a priority review                 $2,562,000
 voucher in addition to the normal PDUFA Fee..
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IV. Implementation of Priority Review 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 FY. 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 priority review fee established in the new fee schedule must be 
paid for any application that is received on or after October 1, 2014, 
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 ``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: August 22, 2014.
Peter Lurie,
Associate Commissioner for Policy and Planning.
[FR Doc. 2014-20360 Filed 8-26-14; 8:45 am]
BILLING CODE 4164-01-P