Fee for Using a Material Threat Medical Countermeasure Priority Review Voucher in Fiscal Year 2019, 48617-48619 [2018-20910]

Download as PDF daltland on DSKBBV9HB2PROD with NOTICES Federal Register / Vol. 83, No. 187 / Wednesday, September 26, 2018 / Notices and other applicable disclosure law. For more information about FDA’s posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.gpo.gov/ fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https:// www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ‘‘Search’’ box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Kalyani Bhatt, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993–0002, 301– 796–9001, Fax: 301–847–8533, email: kalyani.bhatt@fda.hhs.gov, or FDA Advisory Committee Information Line, 1–800–741–8138 (301–443–0572 in the Washington, DC area). A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check FDA’s website at https://-www.fda.gov/ Advisory-Committees/default.htm and scroll down to the appropriate advisory committee meeting link, or call the advisory committee information line to learn about possible modifications before coming to the meeting. SUPPLEMENTARY INFORMATION: Agenda: The committees will discuss the efficacy, safety, and benefit-risk profile of new drug application (NDA) 211371, brexanolone 5 mg/mL intravenous injection, submitted by Sage Therapeutics, for the proposed indication of postpartum depression. FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its website prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA’s website after the meeting. Background material is available at https://www.fda.gov/ AdvisoryCommittees/Calendar/ default.htm. Scroll down to the appropriate advisory committee meeting link. Procedure: Interested persons may present data, information, or views, VerDate Sep<11>2014 19:21 Sep 25, 2018 Jkt 244001 orally or in writing, on issues pending before the committees. All electronic and written submissions submitted to the Docket (see ADDRESSES) on or before October 18, 2018, will be provided to the committees. Oral presentations from the public will be scheduled between approximately 1 p.m. and 2 p.m. Those individuals interested in making formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before October 10, 2018. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by October 11, 2018. Persons attending FDA’s advisory committee meetings are advised that the Agency is not responsible for providing access to electrical outlets. For press inquiries, please contact the Office of Media Affairs at fdaoma@ fda.hhs.gov or 301–796–4540. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with disabilities. If you require special accommodations due to a disability, please contact Kalyani Bhatt (see FOR FURTHER INFORMATION CONTACT) at least 7 days in advance of the meeting. FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our website at https://www.fda.gov/Advisory Committees/AboutAdvisoryCommittees/ ucm111462.htm for procedures on public conduct during advisory committee meetings. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). Dated: September 20, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018–20908 Filed 9–25–18; 8:45 am] BILLING CODE 4164–01–P PO 00000 Frm 00033 Fmt 4703 Sfmt 4703 48617 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2018–N–0007] Fee for Using a Material Threat Medical Countermeasure Priority Review Voucher in Fiscal Year 2019 AGENCY: Food and Drug Administration, HHS. ACTION: Notice. 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) 2019. 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 applicants 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 to review of a human drug application designated as 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 2019 and outlines the payment procedures for such fees. FOR FURTHER INFORMATION CONTACT: Lola Olajide, Office of Financial Management, Food and Drug Administration, 8455 Colesville Rd., COLE–14541B, Silver Spring, MD 20993–0002, 240–402–4244. SUPPLEMENTARY INFORMATION: SUMMARY: 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 applicant of an eligible material threat MCM application (as defined in section 565A(a)(4)) shall receive a priority review voucher upon approval of the E:\FR\FM\26SEN1.SGM 26SEN1 48618 Federal Register / Vol. 83, No. 187 / Wednesday, September 26, 2018 / Notices daltland on DSKBBV9HB2PROD with NOTICES 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/prescription druguserfee/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/Medical Countermeasures/MCMLegal RegulatoryandPolicyFramework/ ucm566498.htm. This notice establishes the material threat MCM priority review fee rate for FY 2019 at $2,457,140 and outlines FDA’s procedures for payment of material threat MCM priority review user fees. This rate is effective on October 1, 2018, and will remain in effect through September 30, 2019. II. Material Threat Medical Countermeasure Priority Review User Fee for FY 2019 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, VerDate Sep<11>2014 19:21 Sep 25, 2018 Jkt 244001 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 receives 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 2019, which is to be based on standard cost data from the previous fiscal year, FY 2018. However, the FY 2018 submission cohort has not been closed out yet, thus the cost data for FY 2018 are not complete. The latest year for which FDA has complete cost data is FY 2017. 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 website 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 2017 show standard costs of $5,340,560 for an NME NDA, and $4,596,936 for a BLA. Based on these standard costs, the total cost to review the 57 applications in these two categories in FY 2017 (31 PO 00000 Frm 00034 Fmt 4703 Sfmt 4703 NME NDAs with clinical data and 26 BLAs) was $285,077,688. (Note: These numbers exclude the President’s Emergency Plan for AIDS Relief NDAs; no investigational new drug review costs are included in this amount.) Thirty-three of these applications (20 NDAs and 13 BLAs) received priority review, which would mean that the remaining 24 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 ÷ 6 months) should be applied to nonpriority 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 2017 figures, the costs of a priority and standard review are estimated using the following formula: (33 a × 1.67) + (24a) = $285,077,688 where ‘‘a’’ is the cost of a standard review and ‘‘a 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 $3,603,561 (rounded to the nearest dollar) and the cost of a priority review for NME NDAs and BLAs is 1.67 times that amount, or $6,017,946 (rounded to the nearest dollar). The difference between these two cost estimates, or $2,414,386, represents the incremental cost of conducting a priority review rather than a standard review. For the FY 2019 fee, FDA will need to adjust the FY 2017 incremental cost by the average amount by which FDA’s average costs increased in the 3 years prior to FY 2018, to adjust the FY 2017 amount for cost increases in FY 2018. That adjustment, published in the Federal Register on August 1, 2018 (see 83 FR 37504), setting FY 2019 PDUFA fees, is 1.7708 percent for the most recent year, not compounded. Increasing the FY 2017 incremental priority review cost of $2,414,386 by 1.7708 percent (or 0.017708) results in an estimated cost of $2,457,140 (rounded to the nearest dollar). This is the material threat MCM priority review user fee amount for FY 2019 that must be submitted with a priority review voucher for a human drug application in FY 2019, in addition to any PDUFA fee that is required for such an application. III. Fee Schedule for FY 2019 The fee rate for FY 2019 is set out in table 1: E:\FR\FM\26SEN1.SGM 26SEN1 48619 Federal Register / Vol. 83, No. 187 / Wednesday, September 26, 2018 / Notices TABLE 1—MATERIAL THREAT MEDICAL COUNTERMEASURE PRIORITY REVIEW SCHEDULE FOR FY 2019 Fee category Fee rate for FY 2019 Application submitted with a material threat MCM priority review voucher in addition to the normal PDUFA fee ............................ $2,457,140 daltland on DSKBBV9HB2PROD with NOTICES 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. 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, 2018, 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 https://www.pay.gov/ public/home. 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 website after the user fee ID number is generated. VerDate Sep<11>2014 19:21 Sep 25, 2018 Jkt 244001 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. V. Reference The following reference is on display at 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; it is not available electronically at https:// www.regulations.gov as this reference is copyright protected. FDA has verified the website address, as of the date this document publishes in the Federal Register, but websites are subject to change over time. 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, available at: https:// faculty.fuqua.duke.edu/∼willm/HSM_ PO 00000 Frm 00035 Fmt 4703 Sfmt 4703 RA/Documents/HA2006_Ridley_ Vouchers.pdf. Dated: September 20, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018–20910 Filed 9–25–18; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2014–D–2138] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry: Adverse Event Reporting for Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. DATES: Fax written comments on the collection of information by October 26, 2018. ADDRESSES: To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, Fax: 202– 395–7285, or emailed to oira_ submission@omb.eop.gov. All comments should be identified with the OMB control number 0910–0800. Also include the FDA docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations, Food and Drug Administration, Three White Flint North, 10A–12M, 11601 Landsdown St., North Bethesda, MD 20852, 301–796–5733, PRAStaff@ fda.hhs.gov. SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA SUMMARY: E:\FR\FM\26SEN1.SGM 26SEN1

Agencies

[Federal Register Volume 83, Number 187 (Wednesday, September 26, 2018)]
[Notices]
[Pages 48617-48619]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-20910]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-0007]


Fee for Using a Material Threat Medical Countermeasure Priority 
Review Voucher in Fiscal Year 2019

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

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) 2019. 
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 applicants 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 to review of a human drug 
application designated as 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 2019 and 
outlines the payment procedures for such fees.

FOR FURTHER INFORMATION CONTACT: Lola Olajide, Office of Financial 
Management, Food and Drug Administration, 8455 Colesville Rd., COLE-
14541B, Silver Spring, MD 20993-0002, 240-402-4244.

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 applicant of an eligible 
material threat MCM application (as defined in section 565A(a)(4)) 
shall receive a priority review voucher upon approval of the

[[Page 48618]]

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.
    This notice establishes the material threat MCM priority review fee 
rate for FY 2019 at $2,457,140 and outlines FDA's procedures for 
payment of material threat MCM priority review user fees. This rate is 
effective on October 1, 2018, and will remain in effect through 
September 30, 2019.

II. Material Threat Medical Countermeasure Priority Review User Fee for 
FY 2019

    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 receives 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 2019, which is to be based on 
standard cost data from the previous fiscal year, FY 2018. However, the 
FY 2018 submission cohort has not been closed out yet, thus the cost 
data for FY 2018 are not complete. The latest year for which FDA has 
complete cost data is FY 2017. 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 website 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 2017 show standard costs of 
$5,340,560 for an NME NDA, and $4,596,936 for a BLA. Based on these 
standard costs, the total cost to review the 57 applications in these 
two categories in FY 2017 (31 NME NDAs with clinical data and 26 BLAs) 
was $285,077,688. (Note: These numbers exclude the President's 
Emergency Plan for AIDS Relief NDAs; no investigational new drug review 
costs are included in this amount.) Thirty-three of these applications 
(20 NDAs and 13 BLAs) received priority review, which would mean that 
the remaining 24 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 / 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 2017 figures, the costs of a priority and standard 
review are estimated using the following formula:

(33 [alpha] x 1.67) + (24[alpha]) = $285,077,688

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 
$3,603,561 (rounded to the nearest dollar) and the cost of a priority 
review for NME NDAs and BLAs is 1.67 times that amount, or $6,017,946 
(rounded to the nearest dollar). The difference between these two cost 
estimates, or $2,414,386, represents the incremental cost of conducting 
a priority review rather than a standard review.
    For the FY 2019 fee, FDA will need to adjust the FY 2017 
incremental cost by the average amount by which FDA's average costs 
increased in the 3 years prior to FY 2018, to adjust the FY 2017 amount 
for cost increases in FY 2018. That adjustment, published in the 
Federal Register on August 1, 2018 (see 83 FR 37504), setting FY 2019 
PDUFA fees, is 1.7708 percent for the most recent year, not compounded. 
Increasing the FY 2017 incremental priority review cost of $2,414,386 
by 1.7708 percent (or 0.017708) results in an estimated cost of 
$2,457,140 (rounded to the nearest dollar). This is the material threat 
MCM priority review user fee amount for FY 2019 that must be submitted 
with a priority review voucher for a human drug application in FY 2019, 
in addition to any PDUFA fee that is required for such an application.

III. Fee Schedule for FY 2019

    The fee rate for FY 2019 is set out in table 1:

[[Page 48619]]



Table 1--Material Threat Medical Countermeasure Priority Review Schedule
                               for FY 2019
------------------------------------------------------------------------
                                                         Fee rate for FY
                      Fee category                             2019
------------------------------------------------------------------------
Application submitted with a material threat MCM             $2,457,140
 priority review voucher in addition to the normal
 PDUFA fee.............................................
------------------------------------------------------------------------

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.
    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, 2018, 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 https://www.pay.gov/public/home. 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 website 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.

V. Reference

    The following reference is on display at 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; it is not 
available electronically at https://www.regulations.gov as this 
reference is copyright protected. FDA has verified the website address, 
as of the date this document publishes in the Federal Register, but 
websites are subject to change over time.

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, available at: https://faculty.fuqua.duke.edu/~willm/
HSM_RA/Documents/HA2006_Ridley_Vouchers.pdf.

    Dated: September 20, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-20910 Filed 9-25-18; 8:45 am]
 BILLING CODE 4164-01-P
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