[Federal Register Volume 82, Number 189 (Monday, October 2, 2017)]
[Notices]
[Pages 45859-45861]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-21191]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Fee for Using a Material Threat Medical Countermeasure Priority 
Review Voucher in Fiscal Year 2018

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 rate for using a material threat medical 
countermeasure (MCM) priority review voucher for fiscal year (FY) 2018. 
The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by 
the 21st Century Cures Act (Cures Act), authorizes FDA to determine and 
collect material threat MCM priority review user fees for certain 
applications for review of human drug products when those applications 
use a material threat MCM priority review voucher. These vouchers are 
awarded to the sponsors of material threat MCM applications that meet 
all of the requirements of this program upon FDA approval of such 
applications. The amount of the fee for using a material threat MCM 
priority review voucher is determined each FY 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 FY, and the 
average cost incurred in the review of an application that is not 
subject to priority review in the previous FY. This notice establishes 
the material threat MCM priority review fee rate for FY 2018 and 
outlines the payment procedures for such fees.

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 3086 of the Cures Act (Pub. L. 114-255) added section 565A 
to the FD&C Act (21 U.S.C. 360bbb-4a). In section 565A of the FD&C Act, 
Congress encouraged development of material threat MCMs by offering 
additional incentives for obtaining FDA approval of such products. 
Under section 565A of the FD&C Act, the sponsor of an eligible material 
threat MCM application (as defined in section 565A(a)(4)) shall receive 
a priority review voucher upon approval of the material threat MCM 
application. The recipient of a material threat MCM priority review 
voucher may either use the voucher for a future human drug application 
submitted to FDA under section 505(b)(1) of the FD&C Act (21 U.S.C. 
355(b)(1)) or section 351(a) of the Public Health Service Act (42 
U.S.C. 262(a)), 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 on the type of application. 
Information regarding PDUFA goals is available at https://www.fda.gov/downloads/forindustry/userfees/prescriptiondruguserfee/ucm511438.pdf.
    The applicant that uses a material threat MCM priority review 
voucher is entitled to a priority review of its eligible human drug 
application, but must pay FDA a material threat MCM priority review 
user fee in addition to any user fee required by PDUFA for the 
application. Information regarding the material threat MCM priority 
review voucher program is available at: https://www.fda.gov/EmergencyPreparedness/Counterterrorism/MedicalCountermeasures/MCMLegalRegulatoryandPolicyFramework/ucm566498.htm#prv.
    This notice establishes the material threat MCM priority review fee 
rate for FY 2018 at $2,830,579 and outlines FDA's procedures for 
payment of material threat MCM priority review user fees. This rate is 
effective on October 1, 2017, and will remain in effect through 
September 30, 2018.

[[Page 45860]]

II. Material Threat Medical Countermeasure Priority Review User Fee for 
FY 2018

    FDA interprets section 565A(c)(2) of the FD&C Act as requiring that 
FDA determine the amount of the material threat MCM 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 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 has 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.
    As interpreted by FDA, section 565A of the FD&C Act requires 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 the Agency in the review of a human drug 
application not subject to a priority review in the previous fiscal 
year. FDA is setting a fee for FY 2018, which is to be based on 
standard cost data from the previous fiscal year, FY 2017. However, the 
FY 2017 submission cohort has not been closed out yet, thus 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 
publishes 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 cost worksheets for FY 2016 show standard costs 
(rounded to the nearest hundred dollars) of $5,929,100 for an 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 
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 
schedule 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 that 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 September 14, 2017 (see 82 FR 43244 at 43245), 
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 
material threat MCM 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--Material Threat Medical Countermeasure Priority Review Schedule
                               for FY 2018
------------------------------------------------------------------------
                                                           Fee rate for
                      Fee category                            FY 2018
------------------------------------------------------------------------
Application submitted with a material threat MCM              $2,830,579
 priority review voucher in addition to the normal PDUFA
 fee....................................................
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IV. Implementation of Material Threat Medical Countermeasure Priority 
Review User Fee

    Under section 565A(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 565A(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, section 
565A(c)(4)(C) specifies that FDA may not grant a waiver, exemption, 
reduction, or refund of any fees due and payable under this section of 
the FD&C Act. FDA's appropriation for FY 2018, states specifically that 
``medical

[[Page 45861]]

countermeasure priority review voucher user fees authorized by 21 
U.S.C. 360bbb-4a, shall be credited to this account, to remain 
available until expended.'' (Pub. L. 115-31, Division A, Title VI).
    The material threat MCM 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 must 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 must 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 
``Material Threat Medical Countermeasure Priority Review.'' All paper 
checks must 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, 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 28, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-21191 Filed 9-29-17; 8:45 am]
 BILLING CODE 4164-01-P