[Federal Register Volume 79, Number 106 (Tuesday, June 3, 2014)]
[Proposed Rules]
[Page 31901]
[FR Doc No: 2014-12798]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 60

[EPA-HQ-OAR-2013-0696; FRL-9911-72-OAR]
RIN 2060-5689

Performance Specification 18--Specifications and Test Procedures
for Gaseous HCl Continuous Emission Monitoring Systems at Stationary
Sources

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule; extension of public comment period.

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SUMMARY: The Environmental Protection Agency (EPA) is announcing that
the period for providing public comments on the May 14, 2014, proposed
``Performance Specification 18--Specifications and Test Procedures for
Gaseous HCl Continuous Emission Monitoring Systems at Stationary
Sources'' is being extended by 30 days.

DATES: The public comment period for the proposed rule published May
14, 2014 (79 FR 27690) is being extended by 30 days to July 13, 2014,
in order to provide the public additional time to submit comments and
supporting information.

ADDRESSES: Written comments on the proposed rule may be submitted to
the EPA electronically, by mail, by facsimile or through hand delivery/
courier. Please refer to the proposal (79 FR 27690) for the addresses
and detailed instructions.
    Docket. Publicly available documents relevant to this action are
available for public inspection either electronically at http://www.regulations.gov or in hard copy at the EPA Docket Center, Room
3334, 1301 Constitution Ave. NW., Washington, DC. The Public Reading
Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday,
excluding legal holidays. A reasonable fee may be charged for copying.
The EPA has established the official public docket No. EPA-HQ-OAR-2013-
0696.

FOR FURTHER INFORMATION CONTACT: Ms. Candace Sorrell, Office of Air
Quality Planning and Standards, Air Quality Assessment Division (AQAD),
Measurement Technology Group, U.S. Environmental Protection Agency,
Research Triangle Park, North Carolina 27709; telephone number: (919)
541-1064; fax number:<PHONE_NUMBER>; email address:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Comment Period

    The EPA is extending the public comment period for an additional 30
days. The public comment period will end on July 13, 2014, rather than
June 13, 2014. This will ensure that the public has sufficient time to
review and comment on all of the information available, including the
proposed rule.

List of Subjects in 40 CFR Part 60

    Environmental protection, Administrative practice and procedure,
Air pollution control, Continuous emission monitoring systems, Hydrogen
chloride, Performance specifications, Test methods and procedures.

    Dated: May 27, 2014.
Mary Henigin,
Director, Office of Air Quality Planning and Standards.
[FR Doc. 2014-12798 Filed 6-2-14; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 79, Number 1 (Thursday, January 2, 2014)]
[Notices]
[Page 131]
[FR Doc No: 2013-31401]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RM14-4-000]

North American Electric Reliability Corporation, Western
Electricity Coordinating Council; Notice of Filing

    Take notice that on December 20, 2013, the North American Electric
Reliability Corporation (NERC) and the Western Electricity Coordinating
Council submitted a joint petition requesting the Federal Energy
Regulatory Commission (FERC or Commission) approve, in accordance with
section 215(d)(1) of the Federal Power Act and section 39.5 of the
Commission's regulations, 18 CFR 39.5, the Western Electricity
Coordinating Council Regional Reliability Standard IRO-006-WECC-2-
Qualified Transfer Path Unscheduled Flow Relief.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed on or before the comment date. On or
before the comment date, it is not necessary to serve motions to
intervene or protests on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov. Persons unable to file electronically should submit an
original and 5 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive email
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please email
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: 5:00 p.m. Eastern Time on January 27, 2014.

    Dated: December 26, 2013.
Kimberly D. Bose,
Secretary.
[FR Doc. 2013-31401 Filed 12-31-13; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 88, Number 70 (Wednesday, April 12, 2023)]
[Notices]
[Pages 22084-22086]
[FR Doc No: 2023-07649]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2014-0379; FMCSA-2016-0011; FMCSA-2016-0313; FMCSA-
2018-0057; FMCSA-2020-0045; FMCSA-2020-0047; FMCSA-2020-0053]

Qualification of Drivers; Exemption Applications; Epilepsy and
Seizure Disorders

AGENCY: Federal Motor Carrier Safety Administration (FMCSA), Department
of Transportation (DOT).

ACTION: Notice of renewal of exemptions; request for comments.

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SUMMARY: FMCSA announces its decision to renew exemptions for 13

individuals from the requirement in the Federal Motor Carrier Safety
Regulations (FMCSRs) that interstate commercial motor vehicle (CMV)
drivers have ``no established medical history or clinical diagnosis of
epilepsy or any other condition which is likely to cause loss of
consciousness or any loss of ability to control a CMV.'' The exemptions
enable these individuals who have had one or more seizures and are
taking anti-seizure medication to continue to operate CMVs in
interstate commerce.

DATES: Each group of renewed exemptions were applicable on the dates
stated in the discussions below and will expire on the dates stated in
the discussions below. Comments must be received on or before May 12,
2023.

ADDRESSES: You may submit comments identified by the Federal Docket
Management System Docket No. FMCSA-2014-0379, Docket No. FMCSA-2016-
0011, Docket No. FMCSA-2016-0313, Docket No. FMCSA-2018-0057, Docket
No. FMCSA-2020-0045, Docket No. FMCSA-2020-0047, or Docket No. FMCSA-
2020-0053 using any of the following methods:
     Federal eRulemaking Portal: Go to www.regulations.gov/,
insert the docket number (FMCSA-2014-0379, FMCSA-2016-0011, FMCSA-2016-
0313, FMCSA-2018-0057, FMCSA-2020-0045, FMCSA-2020-0047, or FMCSA-2020-
0053) in the keyword box and click ``Search.'' Next, sort the results
by ``Posted (Newer-Older),'' choose the first notice listed, and click
on the ``Comment'' button. Follow the online instructions for
submitting comments.
     Mail: Dockets Operations; U.S. Department of
Transportation, 1200 New Jersey Avenue SE, West Building Ground Floor,
Room W12-140, Washington, DC 20590-0001.
     Hand Delivery: West Building Ground Floor, Room W12-140,
1200 New Jersey Avenue SE, Washington, DC 20590-0001 between 9 a.m. and
5 p.m. ET Monday through Friday, except Federal Holidays.
     Fax:<PHONE_NUMBER>.
    To avoid duplication, please use only one of these four methods.
See the ``Public Participation'' portion of the SUPPLEMENTARY
INFORMATION section for instructions on submitting comments.

FOR FURTHER INFORMATION CONTACT: Ms. Christine A. Hydock, Chief,
Medical Programs Division, FMCSA, DOT, 1200 New Jersey Avenue SE, Room
W64-224, Washington, DC 20590-0001,<PHONE_NUMBER>,
[email protected]. Office hours are from 8:30 a.m. to 5 p.m. ET
Monday through Friday, except Federal holidays. If you have questions
regarding viewing or submitting material to the docket, contact Dockets
Operations,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Public Participation

A. Submitting Comments

    If you submit a comment, please include the docket number for this
notice (Docket No. FMCSA-2014-0379, Docket No. FMCSA-2016-0011, Docket
No. FMCSA-2016-0313, Docket No. FMCSA-2018-0057, Docket No. FMCSA-2020-
0045, Docket No. FMCSA-2020-0047 or Docket No. FMCSA-2020-0053),
indicate the specific section of this document to which each comment
applies, and provide a reason for each suggestion or recommendation.
You may submit your comments and material online or by fax, mail, or
hand delivery, but please use only one of these means. FMCSA recommends
that you include your name and a mailing address, an email address, or
a phone number in the body of your document so that FMCSA can contact
you if there are questions regarding your submission.
    To submit your comment online, go to www.regulations.gov/, insert
the docket number (FMCSA-2014-0379, FMCSA-2016-0011, FMCSA-2016-0313,
FMCSA-2018-0057, FMCSA-2020-0045, FMCSA-2020-0047, or FMCSA-2020-0053)
in the keyword box and click ``Search.'' Next, sort the results by
``Posted (Newer-Older),'' choose the first notice listed, click the
``Comment'' button, and type your comment into the text box on the
following screen. Choose whether you are submitting your comment as an
individual or on behalf of a third party and then submit.
    If you submit your comments by mail or hand delivery, submit them
in an unbound format, no larger than 8\1/2\ by 11 inches, suitable for
copying and electronic filing. FMCSA will consider all comments and
material received during the comment period.

B. Viewing Comments

    To view comments go to www.regulations.gov. Insert the docket
number (FMCSA-2014-0379, FMCSA-2016-0011, FMCSA-2016-0313, FMCSA-2018-
0057, FMCSA-2020-0045, FMCSA-2020-0047, or FMCSA-2020-0053) in the
keyword box and click ``Search.'' Next, sort the results by ``Posted
(Newer-Older),'' choose the first notice listed, and click ``Browse
Comments.'' If you do not have access to the internet, you may view the
docket online by visiting Dockets Operations in Room W12-140 on the
ground floor of the DOT West Building, 1200 New Jersey Avenue SE,
Washington, DC 20590-0001, between 9 a.m. and 5 p.m. ET Monday through
Friday, except Federal holidays. To be sure someone is there to help
you, please call<PHONE_NUMBER> or<PHONE_NUMBER> before visiting
Dockets Operations.

C. Privacy Act

    In accordance with 49 U.S.C. 31315(b)(6), DOT solicits comments
from the public on the exemption request. DOT posts these comments,
without edit, including any personal information the commenter
provides, to www.regulations.gov. As described in the system of records
notice DOT/ALL 14 (Federal Docket Management System), which can be
reviewed at https://www.transportation.gov/individuals/privacy/privacy-act-system-records-notices, the comments are searchable by the name of
the submitter.

II. Background

    Under 49 U.S.C. 31136(e) and 31315(b), FMCSA may grant an exemption
from the FMCSRs for no longer than a 5-year period if it finds such
exemption would likely achieve a level of safety that is equivalent to,
or greater than, the level that would be achieved absent such
exemption. The statutes also allow the Agency to renew exemptions at
the end of the 5-year period. However, FMCSA grants medical exemptions
from the FMCSRs for a 2-year period to align with the maximum duration
of a driver's medical certification.
    The physical qualification standard for drivers regarding epilepsy
found in 49 CFR 391.41(b)(8) states that a person is physically
qualified to drive a CMV if that person has no established medical
history or clinical diagnosis of epilepsy or any other condition which
is likely to cause the loss of consciousness or any loss of ability to
control a CMV.
    In addition to the regulations, FMCSA has published advisory
criteria \1\ to assist Medical Examiners in determining whether drivers
with certain medical conditions are qualified to operate a CMV in
interstate commerce.
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    \1\ These criteria may be found in APPENDIX A TO PART 391--
MEDICAL ADVISORY CRITERIA, section H. Epilepsy: Sec.  391.41(b)(8),
paragraphs 3, 4, and 5, which is available on the internet at
https://www.gpo.gov/fdsys/pkg/CFR-2015-title49-vol5/pdf/CFR-2015-title49-vol5-part391-appA.pdf.
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    The 13 individuals listed in this notice have requested renewal of
their exemptions from the epilepsy and seizure disorders prohibition in
Sec.  391.41(b)(8), in accordance with

FMCSA procedures. Accordingly, FMCSA has evaluated these applications
for renewal on their merits and decided to extend each exemption for a
renewable 2-year period.

III. Request for Comments

    Interested parties or organizations possessing information that
would otherwise show that any, or all, of these drivers are not
currently achieving the statutory level of safety should immediately
notify FMCSA. The Agency will evaluate any adverse evidence submitted
and, if safety is being compromised or if continuation of the exemption
would not be consistent with the goals and objectives of 49 U.S.C.
31136(e) and 31315(b), FMCSA will take immediate steps to revoke the
exemption of a driver.

IV. Basis for Renewing Exemptions

    In accordance with 49 U.S.C. 31136(e) and 31315(b), each of the 13
applicants has satisfied the renewal conditions for obtaining an
exemption from the epilepsy and seizure disorders prohibition. The 13
drivers in this notice remain in good standing with the Agency, have
maintained their medical monitoring and have not exhibited any medical
issues that would compromise their ability to safely operate a CMV
during the previous 2-year exemption period. In addition, for
commercial driver's license (CDL) holders, the Commercial Driver's
License Information System and the Motor Carrier Management Information
System are searched for crash and violation data. For non-CDL holders,
the Agency reviews the driving records from the State Driver's
Licensing Agency. These factors provide an adequate basis for
predicting each driver's ability to continue to safely operate a CMV in
interstate commerce. Therefore, FMCSA concludes that extending the
exemption for each renewal applicant for a period of 2 years is likely
to achieve a level of safety equal to that existing without the
exemption.
    In accordance with 49 U.S.C. 31136(e) and 31315(b), the following
groups of drivers received renewed exemptions in the month of April and
are discussed below.
    As of April 2, 2023, and in accordance with 49 U.S.C. 31136(e) and
31315(b), the following seven individuals have satisfied the renewal
conditions for obtaining an exemption from the epilepsy and seizure
disorders prohibition in the FMCSRs for interstate CMV drivers:

Sayed Abbed (IL)
Steven Claphan (MI)
Brian Klein (IN)
Thomas Marx (WA)
Jeb McCulla (LA)
Jeffrey Smith, Jr. (FL)
Eric Smits (WI)

    The drivers were included in docket number FMCSA-2020-0045, FMCSA-
2020-0047, or FMCSA-2020-0053. Their exemptions are applicable as of
April 2, 2023 and will expire on April 2, 2025.
    As of April 30, 2023, and in accordance with 49 U.S.C. 31136(e) and
31315(b), the following six individuals have satisfied the renewal
conditions for obtaining an exemption from the epilepsy and seizure
disorders prohibition in the FMCSRs for interstate CMV drivers:

Ryan Babler (WI)
Bradley Hollister (PA)
Sheldon Martin (NY)
Larry Nicholson (NC)
Edgar Snapp (IN)
Daniel Zielinski (OR)

    The drivers were included in docket number FMCSA-2014-0379, FMCSA-
2016-0011, FMCSA-2016-0313, or FMCSA-2018-0057. Their exemptions are
applicable as of April 30, 2023 and will expire on April 30, 2025.

V. Conditions and Requirements

    The exemptions are extended subject to the following conditions:
(1) each driver must remain seizure-free and maintain a stable
treatment during the 2-year exemption period; (2) each driver must
submit annual reports from their treating physicians attesting to the
stability of treatment and that the driver has remained seizure-free;
(3) each driver must undergo an annual medical examination by a
certified ME, as defined by Sec.  390.5; and (4) each driver must
provide a copy of the annual medical certification to the employer for
retention in the driver's qualification file, or keep a copy of his/her
driver's qualification file if he/she is self-employed. The driver must
also have a copy of the exemption when driving, for presentation to a
duly authorized Federal, State, or local enforcement official. The
exemption will be rescinded if: (1) the person fails to comply with the
terms and conditions of the exemption; (2) the exemption has resulted
in a lower level of safety than was maintained before it was granted;
or (3) continuation of the exemption would not be consistent with the
goals and objectives of 49 U.S.C. 31136(e) and 31315(b).

VI. Preemption

    During the period the exemption is in effect, no State shall
enforce any law or regulation that conflicts with this exemption with
respect to a person operating under the exemption.

VII. Conclusion

    Based on its evaluation of the 13 exemption applications, FMCSA
renews the exemptions of the aforementioned drivers from the epilepsy
and seizure disorders prohibition in Sec.  391.41(b)(8). In accordance
with 49 U.S.C. 31136(e) and 31315(b), each exemption will be valid for
2 years unless revoked earlier by FMCSA.

Larry W. Minor,
Associate Administrator for Policy.
[FR Doc. 2023-07649 Filed 4-11-23; 8:45 am]
BILLING CODE 4910-EX-P


[Federal Register Volume 84, Number 189 (Monday, September 30, 2019)]
[Notices]
[Pages 51597-51599]
[FR Doc No: 2019-21198]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-007]

Fee for Using a Material Threat Medical Countermeasure Priority
Review Voucher in Fiscal Year 2020

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) 2020.
The Federal Food, Drug, and Cosmetic Act (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 the requirements of this program and 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 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 2020 and
outlines the payment procedures for such fees.

FOR FURTHER INFORMATION CONTACT: Melissa Hurley, Office of Financial
Management, Food and Drug Administration, 4041 Powder Mill Rd., Rm.
61075, Beltsville, MD 20705-4304,<PHONE_NUMBER>.

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 sponsor 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 2020 at $2,167,116 and outlines FDA's payment procedures
for material threat MCM priority review user fees. This rate is
effective on October 1, 2019, and will remain in effect through
September 30, 2020.

II. Material Threat Medical Countermeasure Priority Review User Fee for
FY 2020

    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.
    FDA is setting a fee for FY 2020, which is to be based on standard
cost data from the previous fiscal year, FY 2019. However, the FY 2019
submission cohort has not been closed out yet, thus the cost data for
FY 2019 are not complete. The latest year for which FDA has complete
cost data is FY 2018. 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. The Agency expects all applications that received
priority review would contain clinical data. The application categories
with clinical data that for which FDA tracks the cost of review are:
(1) New drug applications (NDAs) for a new molecular entity (NME) with
clinical data and (2) biologics license applications (BLAs).
    The total cost for FDA to review NME NDAs with clinical data and
BLAs in FY 2018 was $335,338,639. There was a total of 74 applications
in these two categories (53 NME NDAs with clinical data and 21 BLAs).
(Note: These numbers exclude the President's Emergency Plan for AIDS
Relief NDAs; no investigational new drug review costs are included in
this amount.) Forty-eight of these applications (35 NDAs and 13 BLAs)
received priority review and 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 / 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 2018
figures, the costs of a priority and standard review are estimated
using the following formula:

(48 [alpha] x 1.67) + (26 [alpha]) = $335,338,639

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
$3,158,804 (rounded to the nearest dollar) and the cost of a priority
review for NME NDAs and BLAs is 1.67 times that amount, or $5,275,203
(rounded to the nearest dollar). The difference between these two cost
estimates, or $2,116,399, represents the incremental cost of conducting
a priority review rather than a standard review.
    For the FY 2020 fee, FDA will need to adjust the FY 2018
incremental cost by the average amount by which FDA's average costs
increased in the 3 years prior to FY 2019, to adjust the FY 2018 amount
for cost increases in FY 2019. That adjustment, published in the
Federal Register on August 1, 2019 (see 84 FR 37882), setting FY 2020
PDUFA fees, is 2.3964 percent for the most recent year, not compounded.
Increasing the FY 2018 incremental priority review cost of $2,116,399
by 2.3964 percent (or 0.023964) results in an estimated cost of
$2,167,116 (rounded to the nearest dollar). This is the material threat
MCM priority review user fee amount for FY 2020 that must be submitted
with a priority review voucher for a human drug application in FY 2020,
in addition to any PDUFA fee that is required for such an application.

III. Fee Schedule for FY 2020

    The fee rate for FY 2020 is set out in table 1:

Table 1--Material Threat Medical Countermeasure Priority Review Schedule
                               for FY 2020
------------------------------------------------------------------------
                                                         Fee rate for FY
                      Fee category                             2020
------------------------------------------------------------------------
Application submitted with a material threat MCM             $2,167,116
 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 with a priority review
voucher that is received on or after October 1, 2019. 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 website after the
user fee ID number is generated.

    If paying by 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 the 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://www.healthaffairs.org/doi/full/10.1377/hlthaff.25.2.313.

    Dated: September 25, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-21198 Filed 9-27-19; 8:45 am]
BILLING CODE 4164-01-P