[Federal Register Volume 82, Number 187 (Thursday, September 28, 2017)]
[Notices]
[Pages 45296-45298]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-20799]



[[Page 45296]]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-0007]


Fee for Using a Tropical Disease Priority Review Voucher in 
Fiscal Year 2018

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) 2018. 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 2018.

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 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/ucm511438.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 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 2018 as $2,830,579 and outlines FDA's process for 
implementing the collection of the priority review user fees. This rate 
is effective on October 1, 2017, and will remain in effect through 
September 30, 2018, 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 2018

    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.
    FDA is setting fees for FY 2018, and the previous fiscal year is FY 
2017. However, the FY 2017 submission cohort has not been closed out 
yet, and the cost data for FY 2017 are not complete. The latest year 
for which FDA has complete cost data is FY 2016. 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 2016, show a standard cost 
(rounded to the nearest hundred dollars) of $5,929,100 for a NME NDA 
and $4,887,100 for a BLA. Based on these standard costs, the total cost 
to review the 49 applications in these two categories in FY 2016 (27 
NME NDAs with clinical data and 22 BLAs) was $267,601,900. (Note: These 
numbers exclude the President's Emergency Plan for AIDS Relief NDAs; no

[[Page 45297]]

investigational new drug review costs are included in this amount.) 
Twenty-three of these applications (14 NDAs and 9 BLAs) received 
priority review, which would mean that the remaining 26 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 2016 figures, the costs of a priority and standard review are 
estimated using the following formula:

(23 [alpha] x 1.67) + (26 [alpha]) = $267,601,900
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 
$4,154,664 (rounded to the nearest dollar) and the cost of a priority 
review for NME NDAs and BLAs is 1.67 times that amount, or $6,938,289 
(rounded to the nearest dollar). The difference between these two cost 
estimates, or $2,783,625, represents the incremental cost of conducting 
a priority review rather than a standard review.
    For the FY 2018 fee, FDA will need to adjust the FY 2016 
incremental cost by the average amount by which FDA's average costs 
increased in the 3 years prior to FY 2017, to adjust the FY 2016 amount 
for cost increases in FY 2017. That adjustment, published in the 
Federal Register on July 28, 2016 (see 81 FR 49674 at 49676), setting 
FY 2018 PDUFA fees, is 1.6868 percent for the most recent year, not 
compounded. Increasing the FY 2016 incremental priority review cost of 
$2,783,625 by 1.6868 percent (or 0.016868) results in an estimated cost 
of $2,830,579 (rounded to the nearest dollar). This is the tropical 
disease priority review user fee amount for FY 2018 that must be 
submitted with a priority review voucher for a human drug application 
in FY 2018, in addition to any PDUFA fee that is required for such an 
application.

III. Fee Schedule for FY 2018

    The fee rate for FY 2018 is set out in table 1:

     Table 1--Tropical Disease Priority Review Schedule for FY 2018
------------------------------------------------------------------------
                                                         Fee rate for FY
                      Fee category                             2018
------------------------------------------------------------------------
Application submitted with a tropical disease priority       $2,830,579
 review voucher in addition to the normal PDUFA fee....
------------------------------------------------------------------------

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 section 524 of the FD&C Act (see section 524(c)(4)(C)) 
and FDA may not collect priority review voucher fees ``except to the 
extent provided in advance in appropriation Acts.'' (Section 
524(c)(5)(B) of the FD&C Act.) 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 [i.e., 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, 2017, and submitted with a priority review voucher. This fee 
must be paid in addition to any other fee due under PDUFA. Payment 
should 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. (Note: Only 
full payments are accepted. No partial payments can be made online). 
Once you search for your invoice, select ``Pay Now'' to be redirected 
to Pay.gov. Note that electronic payment options are based on the 
balance due. Payment by credit card is available for balances that are 
less than $25,000. If the balance exceeds this amount, only the ACH 
option is available. Payments should be made using U.S bank accounts as 
well as U.S. credit cards.
    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.
    If paying with a paper check the user fee identification (ID) 
number should be included on the check, followed by the words 
``Tropical Disease Priority Review.'' All paper checks should be in 
U.S. currency from a U.S. bank made payable and 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. If needed, FDA's tax identification number 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. If the financial 
institution charges a wire transfer fee, it is required to add that 
amount to the payment to ensure that the invoice is paid in full. 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.

V. Reference

    The following reference is on display in the Dockets Management 
Staff (HFA-305), Food and Drug Administration,

[[Page 45298]]

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 22, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-20799 Filed 9-27-17; 8:45 am]
 BILLING CODE 4164-01-P