[Federal Register Volume 78, Number 172 (Thursday, September 5, 2013)]
[Notices]
[Pages 54656-54657]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-21542]



[[Page 54656]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0007]


Fee for Using a Priority Review Voucher in Fiscal Year 2014

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) 2014. 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 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 to be submitted to 
FDA with applications using a 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 priority review fee rate for FY 2014.

FOR FURTHER INFORMATION CONTACT: David Miller, Office of Financial 
Management (HFA-100), Food and Drug Administration, 1350 Piccard Dr., 
Rockville, MD 20850, 301-796-7103.

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 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 (21 
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 has published a draft guidance 
on its Web site about how this priority review voucher program will 
operate (available at http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm080599.pdf).
    This notice establishes the priority review fee rate for FY 2014 as 
$2,325,000 and outlines FDA's process for implementing the collection 
of the priority review user fees. This rate is effective on October 1, 
2013, and will remain in effect through September 30, 2014, for 
applications submitted with a 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. Priority Review User Fee for FY 2014

    Under section 524(c)(2) of the FD&C Act, the amount of the priority 
review user fee is to be determined each FY based on the average cost 
incurred by FDA in the review of a human drug applications 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 
used prior to FY 2013 to calculate the priority review user fee was 
based on the full average cost of a priority review. In FY 2013 FDA 
revised the formula to better approximate the current and ongoing 
incremental FDA resource costs for a priority review. The formula used 
for FY 2013 and subsequent years 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, would provide safe and 
effective therapy where no satisfactory alternative therapy exists or 
would be 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, would be a significant 
improvement in the safety or effectiveness of the treatment, diagnosis, 
or prevention of a serious or life-threatening disease. FDA has 
committed to a goal to review and act on 90 percent of the applications 
that have been 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 for a priority review 
in the previous FY. 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 started by using 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 standard costs for FY 2012, the latest year for which standard 
cost data are available, are (rounded to the nearest thousand dollars) 
$3,279,000 for a new molecular entity NDA and $5,906,000 for a BLA. 
Based on these standard costs, the total cost to review the 54 
applications in these two categories in FY 2012 (18 BLAs and 36 NDAs 
with

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clinical data) was $224,352,000. (Note: no investigational new drug 
(IND) review costs are included in this amount.) A total of 18 of these 
applications (12 NDAs [excluding the President's Emergency Plan for 
Aids Relief NDAs] and 6 BLAs) received priority review, which would 
mean that the remaining 36 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 2012 figures, the 
costs of a priority and standard review are estimated using the 
following formula:

(18 [alpha] x 1.67) + (36 [alpha]) = $224,352,000
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 NMEs is calculated to be $3,396,000 (rounded 
to the nearest thousand dollars) and the cost of a priority review for 
NMEs is 1.67 times that amount, or $5,671,000 (rounded to the nearest 
thousand dollars). The difference between these two cost estimates, or 
$2,275,000, represents the incremental cost of conducting a priority 
review rather 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 for a priority review 
in the previous FY. FDA is setting fees for FY 2014, and the previous 
fiscal year is FY 2013. However, the FY 2013 submission cohort has not 
been closed out yet, and the cost data for FY 2013 are not complete. 
The latest year for which FDA has complete cost data is FY 2012, so 
that must be adjusted for inflation in order to estimate the FY 2013 
cost. Accordingly, FDA will adjust the FY 2012 incremental cost figure 
by the average amount by which FDA's average costs increased in the 3 
years prior to FY 2013, to adjust the FY 2012 amount for cost increases 
in FY 2013. That figure, published in the Federal Register notice on 
August 2, 2013 (see 78 FR 46980 at 46982), setting PDUFA fees for FY 
2014, is 2.20 percent. Increasing the FY 2012 incremental priority 
review cost figure of $2,275,000 by 2.20 percent results in an 
estimated cost of $2,325,000 (rounded to the nearest thousand dollars). 
This is the priority review user fee amount for FY 2014 that must be 
submitted with a priority review voucher in FY 2014, in addition to any 
PDUFA fee that is required for such an application.

III. Priority Review Fee Schedule for FY 2014

    The fee rate for FY 2014 is set out in Table 1 of this document:

              Table 1--Priority Review Schedule for FY 2014
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                                                         Fee rate for FY
                      Fee category                             2014
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Applications Submitted with a Priority Review Voucher        $2,325,000
 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 the 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. 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 after September 30, 2013, 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, Acct. No.: 
75060099, Routing No.: 021030004, SWIFT: FRNYUS33, Beneficiary: FDA, 
1350 Piccard Dr., Rockville, MD 20850.

    Dated: August 29, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-21542 Filed 9-4-13; 8:45 am]
BILLING CODE 4160-01-P