[Federal Register Volume 77, Number 178 (Thursday, September 13, 2012)]
[Notices]
[Pages 56649-56650]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-22587]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0007]


Fee for Using a Priority Review Voucher in Fiscal Year 2013

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

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) 2013. 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 2013.

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 new 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)), 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.
    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 2013 as 
$3,559,000 and outlines FDA's process for implementing the collection 
of the priority review user fees. This rate is effective on October 1, 
2012, and will remain in effect through September 30, 2013, 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 2013

    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 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 
used in past years to calculate the priority review user fee was based 
on the full average cost of a priority review. After reviewing more 
recent data and experience with the program, FDA has revised the 
formula to better approximate the current and ongoing incremental FDA 
resource costs for a priority review. The new formula will provide 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. Normally, an application for a Center for Drug Evaluation and 
Research (CDER) 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 (CBER) 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 receipt. 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 receipt. 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 and 
kept. 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).

[[Page 56650]]

    The worksheets for standard costs for FY 2011, the latest year for 
which standard cost data are available, show a standard cost (rounded 
to the nearest thousand dollars) of $5,092,000 for a new molecular 
entity NDA and $11,203,000 for a BLA. Based on these standard costs, 
the total cost to review the 46 applications in these two categories in 
FY 2011 (10 BLAs and 36 NDAs with clinical data) was $295,342,000. 
(Note: no investigational new drug (IND) review costs are included in 
this amount.) Records acquired from CDER and CBER by the Office of 
Policy and Planning (OPP), Economics Staff, indicate that a total of 16 
of these applications (12 NDAs [excluding the President's Emergency 
Plan for AIDS Relief NDAs] and 4 BLAs) received priority review, which 
would mean that the remaining 30 received standard reviews. Because a 
priority review compresses a review that ordinarily takes 10 months 
into 6 months, OPP 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 mid-point of this range. Using FY 2011 figures, 
the costs of a priority and standard review are estimated using the 
following formula:

(16 [alpha] * 1.67) + (30 [alpha]) = $295,342,000

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 $5,207,000 (rounded 
to the nearest thousand dollars) and the cost of a priority review for 
NMEs is 1.67 times that amount, or $8,696,000 (rounded to the nearest 
thousand dollars). The difference between these two cost estimates, or 
$3,489,000, 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 2013, and the previous 
fiscal year is FY 2012. However, the FY 2012 submission cohort has not 
been closed out yet, and the cost data for FY 2012 are not complete. 
The latest year for which FDA has complete cost data is FY 2011. 
Accordingly, FDA will adjust the FY 2011 incremental cost figure above 
by the average amount by which FDA's average salary and benefit costs 
increased in the 3 years prior to FY 2012, to adjust the FY 2011 amount 
for cost increases in FY 2012. That figure, published in the Federal 
Register notice on August 1, 2012 setting PDUFA fees for FY 2013, is 
2.01 percent. Increasing the FY 2011 incremental priority review cost 
figure of $3,489,000 by 2.01 percent results in an estimated cost of 
$3,559,000 (rounded to the nearest thousand dollars). This is the 
priority review user fee amount for FY 2013 that must be submitted with 
a priority review voucher in FY 2013, in addition to any PDUFA fee that 
is required for such an application.

III. Priority Review Fee Schedule for FY 2013

    The fee rate for FY 2013 is set out in Table 1 of this document:

              Table 1--Priority Review Schedule for FY 2013
------------------------------------------------------------------------
                                                           Fee rate for
                      Fee category                            FY 2013
------------------------------------------------------------------------
Applications Submitted With a Priority Review Voucher in      $3,559,000
 Addition to the Normal PDUFA Fee.......................
------------------------------------------------------------------------

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, 2012, 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 the Food and Drug Administration 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 30, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-22587 Filed 9-12-12; 8:45 am]
BILLING CODE 4160-01-P