82_FR_46048 82 FR 45859 - Fee for Using a Material Threat Medical Countermeasure Priority Review Voucher in Fiscal Year 2018

82 FR 45859 - Fee for Using a Material Threat Medical Countermeasure Priority Review Voucher in Fiscal Year 2018

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 189 (October 2, 2017)

Page Range45859-45861
FR Document2017-21191

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.

Federal Register, Volume 82 Issue 189 (Monday, October 2, 2017) 
[Federal Register Volume 82, Number 189 (Monday, October 2, 2017)]
[Notices]
[Pages 45859-45861]
From the Federal Register Online  [www.thefederalregister.org]
[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.

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

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....................................................
------------------------------------------------------------------------

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

Federal Register / Vol. 82, No. 189 / Monday, October 2, 2017 / Notices 45859 electronic and written/paper comments The transition date for the end of FDA SUPPLEMENTARY INFORMATION: received, go to https:// support for ADaM IG V 1.0, is March 15, www.regulations.gov and insert the 2018. I. Background docket number, found in brackets in the Section 3086 of the Cures Act (Pub. L. II. Electronic Access heading of this document, into the 114–255) added section 565A to the ‘‘Search’’ box and follow the prompts Persons with access to the Internet FD&C Act (21 U.S.C. 360bbb–4a). In and/or go to the Dockets Management may obtain the referenced material at section 565A of the FD&C Act, Congress Staff, 5630 Fishers Lane, Rm. 1061, http://www.fda.gov/ectd. encouraged development of material Rockville, MD 20852. Dated: September 22, 2017. threat MCMs by offering additional FOR FURTHER INFORMATION CONTACT: Ron Leslie Kux, incentives for obtaining FDA approval Fitzmartin, Center for Drug Evaluation Associate Commissioner for Policy. of such products. Under section 565A of and Research, Food and Drug [FR Doc. 2017–21081 Filed 9–29–17; 8:45 am] the FD&C Act, the sponsor of an eligible Administration, 10903 New Hampshire BILLING CODE 4164–01–P material threat MCM application (as Ave., Bldg. 51, Rm. 1115, Silver Spring, defined in section 565A(a)(4)) shall MD 20993–0002, 301–796–5333, email: receive a priority review voucher upon CDERDataStandards@fda.hhs.gov. DEPARTMENT OF HEALTH AND approval of the material threat MCM HUMAN SERVICES application. The recipient of a material SUPPLEMENTARY INFORMATION: Food and Drug Administration threat MCM priority review voucher I. Background may either use the voucher for a future [Docket No. FDA–2017–N–0007] human drug application submitted to On December 17, 2014, FDA FDA under section 505(b)(1) of the published final guidance for industry Fee for Using a Material Threat Medical FD&C Act (21 U.S.C. 355(b)(1)) or ‘‘Providing Regulatory Submissions in Countermeasure Priority Review Voucher in Fiscal Year 2018 section 351(a) of the Public Health Electronic Format—Standardized Study Data’’ (eStudy Data) posted on FDA’s Service Act (42 U.S.C. 262(a)), or AGENCY: Food and Drug Administration, transfer (including by sale) the voucher Study Data Standards Resources Web HHS. to another party. The voucher may be page at http://www.fda.gov/forindustry/ datastandards/studydatastandards/ ACTION: Notice. transferred (including by sale) default.htm. The eStudy Data guidance repeatedly until it ultimately is used for SUMMARY: The Food and Drug a human drug application submitted to implements the electronic submission Administration (FDA or the Agency) is requirements of section 745A(a) of the FDA under section 505(b)(1) of the announcing the fee rate for using a FD&C Act or section 351(a) of the Public Federal Food, Drug, and Cosmetic Act material threat medical countermeasure (21 U.S.C. 379k–1(a)) for study data Health Service Act. A priority review is (MCM) priority review voucher for fiscal a review conducted with a Prescription contained in new drug applications year (FY) 2018. The Federal Food, Drug, (NDAs), abbreviated new drug Drug User Fee Act (PDUFA) goal date of and Cosmetic Act (the FD&C Act), as applications (ANDAs), biologics license 6 months after the receipt or filing date, amended by the 21st Century Cures Act applications (BLAs), and investigational (Cures Act), authorizes FDA to depending on the type of application. new drug applications (INDs) to the determine and collect material threat Information regarding PDUFA goals is Center for Biologics Evaluation and MCM priority review user fees for available at https://www.fda.gov/ Research (CBER) or CDER by specifying certain applications for review of downloads/forindustry/userfees/ the format for electronic submissions. human drug products when those prescriptiondruguserfee/ The implementation of electronic applications use a material threat MCM ucm511438.pdf. submission requirements for study data priority review voucher. These vouchers The applicant that uses a material became effective on December 17, 2016 are awarded to the sponsors of material threat MCM priority review voucher is (24 months after issuance of final threat MCM applications that meet all of entitled to a priority review of its guidance for NDAs, BLAs, ANDAs, and the requirements of this program upon eligible human drug application, but 36 months for INDs). The eStudy Data FDA approval of such applications. The must pay FDA a material threat MCM guidance states that a Federal Register amount of the fee for using a material priority review user fee in addition to notice will specify the transition date threat MCM priority review voucher is for all version updates (with the month any user fee required by PDUFA for the determined each FY based on the application. Information regarding the and day for the transition date difference between the average cost corresponding to March 15). material threat MCM priority review incurred by FDA in the review of a voucher program is available at: https:// The transition date for support of human drug application subject to www.fda.gov/EmergencyPreparedness/ version 1.1 of ADaM 1G V 1.1 is March priority review in the previous FY, and Counterterrorism/Medical 15, 2018. ADaM IG V.1.1 is supported the average cost incurred in the review of an application that is not subject to Countermeasures/MCMLegalRegulatory as of this Federal Register notice and priority review in the previous FY. This andPolicyFramework/ sponsors or applicants are encouraged notice establishes the material threat ucm566498.htm#prv. to begin using it, the new version will only be required in submissions for MCM priority review fee rate for FY This notice establishes the material studies that start after March 15, 2019. 2018 and outlines the payment threat MCM priority review fee rate for sradovich on DSK3GMQ082PROD with NOTICES The Catalog will list March 15, 2019, procedures for such fees. FY 2018 at $2,830,579 and outlines which will be reflected in the Catalog, FOR FURTHER INFORMATION CONTACT: FDA’s procedures for payment of as the ‘‘date requirement begins.’’ When Robert J. Marcarelli, Office of Financial material threat MCM priority review multiple versions of an FDA-supported Management, Food and Drug user fees. This rate is effective on standard are listed in the Catalog, Administration, 8455 Colesville Rd., October 1, 2017, and will remain in sponsors or applicants can select any of COLE–14202F, Silver Spring, MD effect through September 30, 2018. those version to use. 20993–0002, 301–796–7223. VerDate Sep<11>2014 19:01 Sep 29, 2017 Jkt 244001 PO 00000 Frm 00065 Fmt 4703 Sfmt 4703 E:\FR\FM\02OCN1.SGM 02OCN1

45860 Federal Register / Vol. 82, No. 189 / Monday, October 2, 2017 / Notices II. Material Threat Medical review in the previous fiscal year. FDA estimating the effort and cost of a Countermeasure Priority Review User is setting a fee for FY 2018, which is to priority review as compared to a Fee for FY 2018 be based on standard cost data from the standard review. This multiplier is previous fiscal year, FY 2017. However, consistent with published research on FDA interprets section 565A(c)(2) of the FY 2017 submission cohort has not this subject that supports a priority the FD&C Act as requiring that FDA been closed out yet, thus the cost data review multiplier in the range of 1.48 to determine the amount of the material for FY 2017 are not complete. The latest 2.35 (Ref. 1). Using FY 2016 figures, the threat MCM priority review user fee year for which FDA has complete cost costs of a priority and standard review each fiscal year based on the difference data is FY 2016. Furthermore, because are estimated using the following between the average cost incurred by FDA has never tracked the cost of formula: FDA in the review of a human drug reviewing applications that get priority application subject to priority review in (23 a × 1.67) + (26 a) = $267,601,900 review as a separate cost subset, FDA the previous fiscal year, and the average estimated this cost based on other data Where ‘‘a’’ is the cost of a standard review cost incurred by FDA in the review of that the Agency has tracked. FDA uses and ‘‘a times 1.67’’ is the cost of a priority a human drug application that is not review. data that the Agency estimates and subject to priority review in the publishes on its Web site each year— Using this formula, the cost of a previous fiscal year. standard costs for review. FDA does not standard review for NME NDAs and A priority review is a review publish a standard cost for ‘‘the review BLAs is calculated to be $4,154,664 conducted with a PDUFA goal date of 6 of a human drug application subject to (rounded to the nearest dollar) and the months after the receipt or filing date, priority review in the previous fiscal cost of a priority review for NME NDAs depending on the type of application. year.’’ However, we expect all such and BLAs is 1.67 times that amount, or Under the PDUFA goals letter, FDA has applications would contain clinical $6,938,289 (rounded to the nearest committed to reviewing and acting on data. The standard cost application dollar). The difference between these 90 percent of the applications granted categories with clinical data that FDA two cost estimates, or $2,783,625, priority review status within this publishes each year are: (1) New drug represents the incremental cost of expedited timeframe. Normally, an applications (NDAs) for a new conducting a priority review rather than application for a human drug product molecular entity (NME) with clinical a standard review. will qualify for priority review if the data and (2) biologics license For the FY 2018 fee, FDA will need product is intended to treat a serious applications (BLAs). to adjust the FY 2016 incremental cost condition and, if approved, would The standard cost worksheets for FY by the average amount by which FDA’s provide a significant improvement in 2016 show standard costs (rounded to average costs increased in the 3 years safety or effectiveness. An application the nearest hundred dollars) of prior to FY 2017, to adjust the FY 2016 that does not receive a priority $5,929,100 for an NME NDA, and amount for cost increases in FY 2017. designation will receive a standard $4,887,100 for a BLA. Based on these That adjustment, published in the review. Under the PDUFA goals letter, standard costs, the total cost to review Federal Register on September 14, 2017 FDA has committed to reviewing and the 49 applications in these two (see 82 FR 43244 at 43245), setting FY acting on 90 percent of standard categories in FY 2016 (27 NME NDAs 2018 PDUFA fees, is 1.6868 percent for applications within 10 months of the with clinical data and 22 BLAs) was the most recent year, not compounded. receipt or filing date, depending on the $267,601,900. (NOTE: These numbers Increasing the FY 2016 incremental type of application. A priority review exclude the President’s Emergency Plan priority review cost of $2,783,625 by involves a more intensive level of effort for AIDS Relief NDAs; no 1.6868 percent (or 0.016868) results in and a higher level of resources than a investigational new drug review costs an estimated cost of $2,830,579 standard review. are included in this amount.) Twenty- (rounded to the nearest dollar). This is As interpreted by FDA, section 565A three of these applications (14 NDAs the material threat MCM priority review of the FD&C Act requires that the fee and 9 BLAs) received priority review, user fee amount for FY 2018 that must amount should be based on the which would mean that the remaining be submitted with a priority review difference between the average cost 26 received standard reviews. Because a voucher for a human drug application in incurred by the Agency in the review of priority review compresses a review FY 2018, in addition to any PDUFA fee a human drug application subject to a schedule that ordinarily takes 10 that is required for such an application. priority review in the previous fiscal months into 6 months, FDA estimates year, and the average cost incurred by that a multiplier of 1.67 (10 months III. Fee Schedule for FY 2018 the Agency in the review of a human divided by 6 months) should be applied The fee rate for FY 2018 is set out in drug application not subject to a priority to non-priority review costs 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 priority review voucher in addition to the normal PDUFA fee ............................ $2,830,579 sradovich on DSK3GMQ082PROD with NOTICES IV. Implementation of Material Threat drug application for which the priority payment procedures. In addition, Medical Countermeasure Priority review voucher is used. Section section 565A(c)(4)(C) specifies that FDA Review User Fee 565A(c)(4)(B) of the FD&C Act specifies may not grant a waiver, exemption, that the application will be considered reduction, or refund of any fees due and Under section 565A(c)(4)(A) of the incomplete if the priority review user payable under this section of the FD&C FD&C Act, the priority review user fee fee and all other applicable user fees are Act. FDA’s appropriation for FY 2018, is due upon submission of a human not paid in accordance with FDA states specifically that ‘‘medical VerDate Sep<11>2014 19:01 Sep 29, 2017 Jkt 244001 PO 00000 Frm 00066 Fmt 4703 Sfmt 4703 E:\FR\FM\02OCN1.SGM 02OCN1

Federal Register / Vol. 82, No. 189 / Monday, October 2, 2017 / Notices 45861 countermeasure priority review voucher tax identification number is 53– Product Radiation Control provisions of user fees authorized by 21 U.S.C. 0196965. the Federal Food, Drug, and Cosmetic 360bbb–4a, shall be credited to this If paying by wire transfer, please Act (the FD&C Act) that apply to account, to remain available until reference your unique user fee ID electronic products. When finalized, expended.’’ (Pub. L. 115–31, Division A, number when completing your transfer. this document will supersede the Title VI). The originating financial institution ‘‘Immediately in Effect Guidance The material threat MCM priority may charge a wire transfer fee. If the Document: Classification and review fee established in the new fee financial institution charges a wire Requirements for Laser Illuminated schedule must be paid for any transfer fee, it is required to add that Projectors (LIPs); Guidance for Industry application that is received on or after amount to the payment to ensure that and Food and Drug Administration October 1, 2017, and submitted with a the invoice is paid in full. The account Staff,’’ issued February 18, 2015. This priority review voucher. This fee must information is as follows: U.S. Dept. of draft guidance is not final nor is it in be paid in addition to any other fee due Treasury, TREAS NYC, 33 Liberty St., effect at this time. under PDUFA. Payment must be made New York, NY 10045, Account Number: DATES: Submit either electronic or in U.S. currency by electronic check, 75060099, Routing Number: 021030004, written comments on the draft guidance check, bank draft, wire transfer, credit SWIFT: FRNYUS33, Beneficiary: FDA, by December 1, 2017 to ensure that the card, or U.S. postal money order 8455 Colesville Rd., 14th Floor, Silver Agency considers your comment on this payable to the order of the Food and Spring, MD 20993–0002. draft guidance before it begins work on Drug Administration. The preferred the final version of the guidance. payment method is online using V. Reference ADDRESSES: You may submit comments electronic check (Automated Clearing The following reference is on display on any guidance at any time as follows: House (ACH) also known as eCheck). in the Dockets Management Staff (HFA– Secure electronic payments can be 305), Food and Drug Administration, Electronic Submissions submitted using the User Fees Payment 5630 Fishers Lane, Rm. 1061, Rockville, Submit electronic submissions as Portal at https://userfees.fda.gov/pay. MD 20852, and is available for viewing follows: (NOTE: only full payments are accepted. by interested persons between 9 a.m. • Federal eRulemaking Portal: No partial payments can be made and 4 p.m., Monday through Friday. https://www.regulations.gov. Follow the online.) Once you search for your 1. Ridley, D.B., H.G. Grabowski, and J.L. instructions for submitting comments. invoice, select ‘‘Pay Now’’ to be Moe, ‘‘Developing Drugs for Developing Comments submitted electronically, redirected to Pay.gov. Note that Countries,’’ Health Affairs, vol. 25, no. 2, pp. including attachments, to https:// electronic payment options are based on 313–324, 2006. www.regulations.gov will be posted to the balance due. Payment by credit card Dated: September 28, 2017. the docket unchanged. Because your is available for balances that are less Anna K. Abram, comment will be made public, you are than $25,000. If the balance exceeds this Deputy Commissioner for Policy, Planning, solely responsible for ensuring that your amount, only the ACH option is Legislation, and Analysis. comment does not include any available. Payments must be made using confidential information that you or a [FR Doc. 2017–21191 Filed 9–29–17; 8:45 am] U.S. bank accounts as well as U.S. credit third party may not wish to be posted, BILLING CODE 4164–01–P cards. such as medical information, your or FDA has partnered with the U.S. anyone else’s Social Security number, or Department of the Treasury to use confidential business information, such DEPARTMENT OF HEALTH AND Pay.gov, a web-based payment as a manufacturing process. Please note HUMAN SERVICES application, for online electronic that if you include your name, contact payment. The Pay.gov feature is Food and Drug Administration information, or other information that available on the FDA Web site after the identifies you in the body of your user fee ID number is generated. [Docket No. FDA–2014–D–2245] comments, that information will be If paying with a paper check the user posted on https://www.regulations.gov. Classification and Requirements for fee identification (ID) number should be Laser Illuminated Projectors (Laser • If you want to submit a comment included on the check, followed by the with confidential information that you words ‘‘Material Threat Medical Notice No. 57); Draft Guidance for Industry and Food and Drug do not wish to be made available to the Countermeasure Priority Review.’’ All public, submit the comment as a paper checks must be in U.S. currency Administration Staff; Availability written/paper submission and in the from a U.S. bank made payable and AGENCY: Food and Drug Administration, manner detailed (see ‘‘Written/Paper mailed to: Food and Drug HHS. Submissions’’ and ‘‘Instructions’’). Administration, P.O. Box 979107, St. ACTION: Notice of availability. Louis, MO 63197–9000. 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If you have Draft Guidance for Industry and Food sradovich on DSK3GMQ082PROD with NOTICES Lane, Rm. 1061, Rockville, MD 20852. any questions concerning courier and Drug Administration Staff.’’ When • For written/paper comments delivery, contact the U.S. Bank at 314– finalized, this guidance describes FDA’s submitted to the Dockets Management 418–4013. This telephone number is policy with respect to certain LIPs that Staff, FDA will post your comment, as only for questions about courier comply with International well as any attachments, except for delivery). The FDA post office box Electrotechnical Commission (IEC) information submitted, marked and number (P.O. Box 979107) must be standards during laser product identified, as confidential, if submitted written on the check. If needed, FDA’s classification under the Electronic as detailed in ‘‘Instructions.’’ VerDate Sep<11>2014 19:01 Sep 29, 2017 Jkt 244001 PO 00000 Frm 00067 Fmt 4703 Sfmt 4703 E:\FR\FM\02OCN1.SGM 02OCN1


Document Created: 2017-09-30 04:41:38
Document Modified: 2017-09-30 04:41:38
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
ContactRobert J. Marcarelli, Office of Financial Management, Food and Drug Administration, 8455 Colesville Rd., COLE-14202F, Silver Spring, MD 20993-0002, 301-796-7223.
FR Citation82 FR 45859 
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