[Federal Register Volume 88, Number 164 (Friday, August 25, 2023)]
[Proposed Rules]
[Pages 58232-58233]
[FR Doc No: 2023-18309]

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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

49 CFR Parts 531, 533, 535, and 537

[NHTSA-2023-0022]
RIN 2127-AM55

Public Hearing for Corporate Average Fuel Economy Standards for
Passenger Cars and Light Trucks for Model Years 2027-2032 and Fuel
Efficiency Standards for Heavy-Duty Pickup Trucks and Vans for Model
Years 2030-2035

AGENCY: National Highway Traffic Safety Administration (NHTSA),
Department of Transportation (DOT).

ACTION: Notice of public hearing.

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SUMMARY: The National Highway Traffic Safety Administration (NHTSA) is
announcing a virtual public hearing to be held September 28, 2023, on
its proposal for the ``Corporate Average Fuel Economy Standards for
Passenger Cars and Light Trucks for Model Years 2027-2032 and Fuel
Efficiency Standards for Heavy-Duty Pickup Trucks and Vans for Model
Years 2030-2035,'' which was signed on July 28, 2023. This hearing also
allows the public to provide oral comments regarding the Draft
Environmental Impact Statement that accompanies the proposal. An
additional session will be held on September 29, if necessary, to
accommodate the number of people that sign up to testify.

DATES: NHTSA will hold a virtual public hearing on September 28, 2023.
An additional session will be held on September 29, if necessary, to
accommodate the number of people that sign up to testify. The hearing
will convene at 9 a.m. Eastern time and will conclude when the last
pre-registered speaker has testified but no later than 6 p.m. Eastern
time. All hearing attendees, including those who do not intend to
provide testimony, should preregister by September 22, 2023. Please
refer to the SUPPLEMENTARY INFORMATION section for additional
information on the public hearing.

ADDRESSES: The link to register will be available at https://www.nhtsa.gov/cafe. Additional information regarding the hearing
appears below under SUPPLEMENTARY INFORMATION.

FOR FURTHER INFORMATION CONTACT: For questions regarding how to
register to attend the hearing, please contact NHTSA's Office of
Communications at [email protected]. For any other questions
about this notice, please contact Mark Totten, Office of Rulemaking,
NHTSA, at<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: NHTSA, on behalf of the DOT, is proposing
new corporate average fuel economy (CAFE) standards for passenger cars
and light trucks for MYs 2027-2032, and new fuel efficiency standards
for heavy-duty pickup trucks and vans (HDPUVs) for MYs 2030-2035. This
proposal responds to NHTSA's statutory obligation to set CAFE and HDPUV
standards at the maximum feasible level that the agency determines
vehicle manufacturers can achieve in each MY, in order to improve
energy conservation. Specifically, NHTSA is proposing new fuel economy
standards for passenger cars and light trucks and fuel efficiency
standards for model years (MYs) 2027-31 that increase at a rate of 2
percent per year for passenger cars and 4 percent per year for light
trucks, and new fuel efficiency standards for heavy-duty pickup trucks
and vans (HDPUVs) for MYs 2030-2035 that increase at a rate of 10
percent per year. NHTSA is also setting forth proposed augural
standards for MY 2032 passenger cars and light trucks, which would
increase at 2 percent and 4 percent year over year, respectively, as
compared to the prior year's standards. In addition, NHTSA is also
proposing certain technical amendments to clarify and streamline our
compliance regulations. The proposal was signed on July 28, 2023, and
was published in the Federal Register on August 17, 2023. A notice of
availability for the accompanying Draft Environmental Impact Statement
(Draft EIS) was published in the Federal Register on August 04, 2023
(88 FR 51812). The Draft EIS is available on NHTSA's CAFE website,
https://www.nhtsa.gov/cafe, and is also available in Docket ID No.
NHTSA-2022-0075

Participation in Virtual Public Hearing

    NHTSA will begin pre-registering speakers for the hearing upon
publication of this document in the Federal Register. To register to
speak at the virtual hearing, please follow the instructions below. The
last day to pre-register to speak at the hearing will be September 22,
2023.
     To watch the hearing (without providing oral comments):
Click the link at https://www.nhtsa.gov/cafe and register. Indicate NO
on the registration page that you do not wish to provide testimony.
Within 24 hours of registering, you will be emailed your link to join.

     To comment at the hearing: Click the link at https://www.nhtsa.gov/cafe and register by September 22. Indicate YES on the
registration page that you would like to provide comments. Within 24
hours of registering, you will be emailed your link to join.
Additionally, you will receive an email on September 26 with your
approximate time to testify, and additional information about how to
turn on your audio and camera to comment. We recommend you join via a
computer, but if you are unable to do so, an option to join via phone
will also be provided in that email.
    If you do not receive your confirmation email(s), or have further
questions about this hearing, please email [email protected].
NHTSA is committed to providing equal access to this event for all
participants. Closed captioning will be available. People with
disabilities who need additional accommodations should send a request
to [email protected] no later than September 22.
    Each commenter will have 3 minutes to provide oral testimony. NHTSA
may ask clarifying questions during the oral presentations but will not
otherwise respond to the presentations at that time. NHTSA recommends
submitting the text of your oral comments as written comments to the
rulemaking docket or to the Draft EIS docket, as appropriate. Written
statements and supporting information submitted during the comment
period will be considered with the same weight as oral comments and
supporting information presented at the public hearing. If identical
comments are submitted by the same commenter more than once to the
docket, NHTSA does not consider those comments to carry more weight
than if they had been submitted only once. If the oral testimony is
specifically intended to reference the Draft EIS, please mention that
in your opening remarks.
    Please note that any updates made to any aspects of the hearing
logistics, including any change to the date of the hearing or a
potential additional session on September 29, 2023, will be posted
online at the CAFE website, https://www.nhtsa.gov/cafe. While NHTSA
expects the hearing to go forward as set forth above, please monitor
our website or contact the person listed in the FOR FURTHER INFORMATION
CONTACT section to determine if there are any updates. NHTSA does not
intend to publish a document in the Federal Register announcing
updates. Finally, NHTSA will post a video of the hearing at https://www.nhtsa.gov/cafe and will make a transcript of the hearing available
in the rule making docket as soon as practicable.

How can I get copies of the proposed action, the Draft Environmental
Impact Statement, and other related information?

    NHTSA has established a docket for the proposal under Docket ID No.
NHTSA-2023-0022 and a separate docket for the Draft EIS at Docket ID
No. NHTSA-2022-0075. Relevant documents and information can also be
accessed at NHTSA's CAFE website, at https://www.nhtsa.gov/cafe. Please
refer to the notice of proposed rulemaking for detailed information on
accessing information related to the proposal and the Draft EIS.

    Issued on August 21, 2023, in Washington, DC, under authority
delegated in 49 CFR 1.95.
Ann Carlson,
Acting Administrator.
[FR Doc. 2023-18309 Filed 8-24-23; 8:45 am]
BILLING CODE 4910-59-P


[Federal Register Volume 88, Number 126 (Monday, July 3, 2023)]
[Rules and Regulations]
[Pages 42640-42642]
[FR Doc No: 2023-13979]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R07-OAR-2023-0201; FRL-10839-02-R7]

Air Plan Partial Approval and Partial Disapproval; Missouri;
Revision to Sulfur Dioxide Control Requirements for Lake Road
Generating Facility

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: The Environmental Protection Agency (EPA) is taking final
action to partially approve and partially disapprove revisions to the
State Implementation Plan (SIP) submitted by the State of Missouri on
February 17, 2022. In its submission, the Missouri Department of
Natural Resources (MoDNR) requested that revisions to a 2016
Administrative Order on Consent (AOC) for controlling sulfur dioxide
(SO2) emissions at the Lake Road power plant (hereinafter
referred to as ``2016 AOC'') be approved in the SIP. This final action
amends the SIP to establish more stringent fuel oil sulfur content
limits, remove SO2 emission limits that are no longer needed
due to the strengthened fuel oil sulfur requirements, and streamline
reporting requirements. The approved SIP changes meet the requirements
of the Clean Air Act (CAA). This final action also disapproves a new
provision in the AOC that would potentially allow Lake Road to exceed
the fuel oil sulfur content limits on a temporary basis.

DATES: This final rule is effective on August 2, 2023.

ADDRESSES: The EPA has established a docket for this action under
Docket ID No. EPA-R07-OAR-2023-0201. All documents in the docket are
listed on the www.regulations.gov website. Although listed in the
index, some information is not publicly available, i.e., confidential
business information (CBI) or other information whose disclosure is
restricted by statute. Certain other material, such as copyrighted
material, is not placed on the internet and will be publicly available
only in hard copy form. Publicly available docket materials are
available through www.regulations.gov or please contact the person
identified in the FOR FURTHER INFORMATION CONTACT section for
additional information.

FOR FURTHER INFORMATION CONTACT: Allie Donohue, Environmental
Protection Agency, Region 7 Office, Air Quality Planning Branch, 11201
Renner Boulevard, Lenexa, Kansas 66219; telephone number: (913) 551-
7986; email address: [email protected].

SUPPLEMENTARY INFORMATION: Throughout this document ``we,'' ``us,'' and
``our'' refer to EPA.

Table of Contents

I. What is being addressed in this document?
II. Have the requirements for approval of a SIP revision been met?
III. What action is the EPA taking?
IV. Incorporation by Reference
V. Environmental Justice Considerations
VI. Statutory and Executive Order Reviews

I. What is being addressed in this document?

    The EPA is partially approving and partially disapproving a SIP
revision submitted by the State of Missouri on February 17, 2022. In
its submission, MoDNR requested that AOC No. APCP-2015-118 between
MoDNR and Evergy (formerly Kansas City Power & Light) submitted in
2016, and amended in 2018 (Amendment #1), be replaced with Amendment #2
to the AOC in the SIP. The EPA is approving these SIP revisions, with
the exception of Amendment #2 paragraph 12.A. The approved revisions
meet the requirements of the Clean Air Act. The EPA is disapproving
Amendment #2 paragraph 12.A. because this provision potentially allows
Lake Road to burn fuel oil with a sulfur content greater than the
sulfur content limit of 15 parts per million (ppm) on a temporary
basis. Paragraph 12.A. is severable from Amendment #2 because it is a
new paragraph that was not previously included in the 2016 AOC or
Amendment #1, and it is not approved in the SIP. The EPA proposed to
partially approve and partially disapprove this submission on April 26,
2023 (88 FR 25309). The EPA's analysis of the State's requested SIP
revisions can be found in section II of the proposed rule and in more
detail in the technical support document (TSD) included in this docket.

II. Have the requirements for approval of a SIP revision been met?

    With respect to the portions of the submittal which EPA is
approving, the State submission met the public notice requirements for
SIP submissions in accordance with 40 CFR 51.102. The submission also
satisfied the completeness criteria of 40 CFR part 51, appendix V. The
State provided public notice on this SIP revision from November 1,
2021, to December 9, 2021 and received no comments. In addition, as
explained above and in more detail in the TSD which is part of this
docket, the revision meets the substantive SIP requirements of the CAA,
including section 110 and implementing regulations.
    As explained in section II of the proposed rule and further in the
TSD, the EPA is disapproving Amendment #2 paragraph 12.A.
    The EPA received no comments on the proposed rule during the public
comment period which opened April 26, 2023, the date of its publication
in the Federal Register, and closed on May 26, 2023.

III. What action is the EPA taking?

    The EPA is taking final action to amend the Missouri SIP by
partially approving and partially disapproving the State's submittal.
Under section 179(a) of the CAA, final disapproval of a submittal that
addresses a requirement of part D, title I of the CAA (CAA sections
171-193) or is required in response to a finding of substantial
inadequacy as described in CAA section 110(k)(5) (SIP Call) starts a
sanctions clock. The Missouri SIP submission that we are partially
disapproving was not submitted to meet either of these requirements.
Therefore, this partial disapproval will not trigger mandatory
sanctions under CAA section 179. In addition, CAA section 110(c)(1)
provides that the EPA must promulgate a Federal Implementation Plan
(FIP) within two years after either finding that a State has failed to
make a required submission or disapproving a SIP submission in whole or
in part, unless the EPA approves a SIP revision correcting the
deficiencies within that two-year period. With respect to our partial
disapproval of Missouri's SIP submission, however, we conclude that any
FIP obligation resulting from this partial disapproval is satisfied by
our determination that there is no deficiency in the SIP to correct.
Specifically, we are approving all revisions with the exception of
Amendment #2 paragraph 12.A.

IV. Incorporation by Reference

    In this document, the EPA is finalizing regulatory text that
includes incorporation by reference. In accordance with requirements of
1 CFR 51.5, the EPA is finalizing the incorporation by reference of the
Missouri Amendment #2 to Administrative Order on Consent, State
effective October 18, 2021, between MoDNR and Evergy related to
controlling SO2 emissions at the Lake Road power plant
discussed in section I of this preamble and as set forth below in the
amendments to 40 CFR part 52. The EPA has made, and will continue to
make, these materials generally available through www.regulations.gov
and at the EPA Region 7 Office (please contact the person identified in
the FOR FURTHER INFORMATION CONTACT section of this preamble for more
information).
    Also, in this document, as described in the amendments to 40 CFR
part 52 set forth below, the EPA is removing provisions of the EPA-
Approved Missouri Administrative Order on Consent and Amendment #1
(State effective September 27, 2018) from the Missouri State
Implementation Plan, which is incorporated by reference in accordance
with the requirements of 1 CFR part 51. As described in the amendments
to 40 CFR part 52 set forth below, EPA is also removing an outdated
reference to the St. Joseph Light and Power So2 consent
agreement (State effective May 21, 2001).

V. Environmental Justice Considerations

    The EPA reviewed demographic data, which provides an assessment of
individual demographic groups of the populations living within a 2-mile
radius of the Lake Road facility Census 2010 Summary Report available
on its environmental justice (EJ) screening and mapping tool
(``EJSCREEN''). The EPA then compared the data to the State average for
each of the demographic groups using 2010 State census data from the
United States Census Bureau. The results of this analysis are being
provided for informational and transparency purposes. The results of
the demographic analysis indicate that, for populations within the 2-
mile radius of the Lake Road facility, the percent of people of color
(persons who reported their race as a category other than White alone
(not Hispanic or Latino)) is less than the national average (16 percent
versus 21 percent). Within people of color, the percent of the
population that is Black or African American alone is lower than the
State average (3 percent versus 12 percent) and the percent of the
population that is American Indian/Alaska Native is similar to the
State average (1 percent versus 1 percent). The percent of the
population that is two or more races is similar to the State average (3
percent versus 3 percent). The percent of people with low income within
the 2-mile radius of the Lake Road facility is higher than the State
average (41 percent versus 31 percent).

VI. Statutory and Executive Order Reviews

    Under the Clean Air Act, the Administrator is required to approve a
SIP submission that complies with the provisions of the Clean Air Act
and applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a).
Thus, in reviewing SIP submissions, EPA's role is to approve State
choices, provided that they meet the criteria of the Clean Air Act.
Accordingly, this action merely approves State law as meeting Federal
requirements and does not impose additional requirements beyond those
imposed by State law. For that reason, this action:
     Is not a significant regulatory action subject to review
by the Office of Management and Budget under Executive Orders 12866 (58
FR 51735, October 4, 1993) and 14094 (88 FR 21879, April 11, 2023);
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not subject to Executive Order 13045 (62 FR 19885,
April 23, 1997) because it approves a State program;
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001); and
     Is not subject to requirements of section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the Clean Air Act.
    In addition, the SIP is not approved to apply on any Indian
reservation land or in any other area where EPA or an Indian tribe has
demonstrated that a tribe has jurisdiction. In those areas of

Indian country, the rule does not have tribal implications and will not
impose substantial direct costs on tribal governments or preempt tribal
law as specified by Executive Order 13175 (65 FR 67249, November 9,
2000).
    Executive Order 12898 (Federal Actions To Address Environmental
Justice in Minority Populations and Low-Income Populations, 59 FR 7629,
February 16, 1994) directs Federal agencies to identify and address
``disproportionately high and adverse human health or environmental
effects'' of their actions on minority populations and low-income
populations to the greatest extent practicable and permitted by law.
EPA defines environmental justice (EJ) as ``the fair treatment and
meaningful involvement of all people regardless of race, color,
national origin, or income with respect to the development,
implementation, and enforcement of environmental laws, regulations, and
policies.'' EPA further defines the term fair treatment to mean that
``no group of people should bear a disproportionate burden of
environmental harms and risks, including those resulting from the
negative environmental consequences of industrial, governmental, and
commercial operations or programs and policies.''
    The air agency did not evaluate environmental justice
considerations as part of its SIP submittal; the CAA and applicable
implementing regulations neither prohibit nor require such an
evaluation. The EPA performed an environmental justice analysis, as is
described above in the section titled, ``Environmental Justice
Considerations.'' The analysis was done for the purpose of providing
additional context and information about this rulemaking to the public,
not as a basis of the action. In addition, there is no information in
the record upon which this decision is based inconsistent with the
stated goal of E.O. 12898 of achieving environmental justice for people
of color, low-income populations, and Indigenous peoples.
    This action is subject to the Congressional Review Act, and the EPA
will submit a rule report to each House of the Congress and to the
Comptroller General of the United States. This action is not a ``major
rule'' as defined by 5 U.S.C. 804(2).
    Under section 307(b)(1) of the Clean Air Act, petitions for
judicial review of this action must be filed in the United States Court
of Appeals for the appropriate circuit by September 1, 2023. Filing a
petition for reconsideration by the Administrator of this final rule
does not affect the finality of this action for the purposes of
judicial review nor does it extend the time within which a petition for
judicial review may be filed, and shall not postpone the effectiveness
of such rule or action. This action may not be challenged later in
proceedings to enforce its requirements (see section 307(b)(2)).

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Intergovernmental relations, Reporting and recordkeeping
requirements, Sulfur oxides.

    Dated: June 26, 2023.
Meghan A. McCollister,
Regional Administrator, Region 7.

    For the reasons stated in the preamble, the EPA amends 40 CFR part
52 as set forth below:

PART 52--APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS

0
1. The authority citation for part 52 continues to read as follows:

    Authority:  42 U.S.C. 7401 et seq.

Subpart AA--Missouri

0
2. In Sec.  52.1320, in the table in paragraph (d):
0
a. Remove and reserve entries ``(17)'', ``(32)'', and ``(33)''; and
0
b. Add entry ``(38)'' in numerical order.
    The addition reads as follows:

Sec.  52.1320  Identification of plan.

* * * * *
    (d) * * *

                            EPA-Approved Missouri Source-Specific Permits and Orders
----------------------------------------------------------------------------------------------------------------
                                                        State effective
         Name of source            Order/permit No.          date          EPA approval date      Explanation
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
(38) Kansas City Power and        Amendment #2 to     10/18/2021........  7/3/2023, [insert   EPA is approving
 Light--Lake Road Facility.        Administrative                          Federal Register    Amendment #2 to
                                   Order on Consent                        citation].          AOC No. APCP-2015-
                                   No. APCP-2015-118.                                          118, except for
                                                                                paragraph 12.A.
----------------------------------------------------------------------------------------------------------------

* * * * *
[FR Doc. 2023-13979 Filed 6-30-23; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 83, Number 241 (Monday, December 17, 2018)]
[Notices]
[Page 64571]
[FR Doc No: 2018-27174]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings

    Take notice that the Commission has received the following Natural
Gas Pipeline Rate and Refund Report filings:

Filings Instituting Proceedings

    Docket Numbers: RP19-343-001.
    Applicants: Texas Eastern Transmission, LP.
    Description: Tariff Amendment: Amendment to TETLP 2018 Rate Case
Filing--RP19-343-000 to be effective 1/1/2019.
    Filed Date: 12/7/18.
    Accession Number: 20181207-5177.
    Comments Due: 5 p.m. ET 12/13/18.

    Docket Numbers: RP19-446-000.
    Applicants: Big Sandy Pipeline, LLC.
    Description: Sec.  4(d) Rate Filing: Negotiated Rates--Dec2018
Cleanup Filing to be effective 1/7/2019.
    Filed Date: 12/7/18.
    Accession Number: 20181207-5001.
    Comments Due: 5 p.m. ET 12/19/18.

    Docket Numbers: RP19-447-000.
    Applicants: Texas Eastern Transmission, LP.
    Description: Sec.  4(d) Rate Filing: Negotiated Rates--Dec2018
Cleanup Filing to be effective 1/7/2019.
    Filed Date: 12/7/18.
    Accession Number: 20181207-5004.
    Comments Due: 5 p.m. ET 12/19/18.

    Docket Numbers: RP19-448-000.
    Applicants: Sabine Pipe Line LLC.
    Description: eTariff filing per 1430: 501-G Report Filing to be
effective N/A.
    Filed Date: 12/7/18.
    Accession Number: 20181207-5026.
    Comments Due: 5 p.m. ET 12/19/18.

    Docket Numbers: RP19-449-000.
    Applicants: Northern Natural Gas Company.
    Description: Sec.  4(d) Rate Filing: 20181207 Negotiated Rate to be
effective 12/8/2018.
    Filed Date: 12/7/18.
    Accession Number: 20181207-5172.
    Comments Due: 5 p.m. ET 12/19/18.

    Docket Numbers: RP19-450-000.
    Applicants: Trans-Union Interstate Pipeline, L.P.
    Description: eTariff filing per 1430: Trans-Union Form 501-G
Refiling to be effective N/A.
    Filed Date: 12/7/18.
    Accession Number: 20181207-5217.
    Comments Due: 5 p.m. ET 12/19/18.

    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: December 10, 2018.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2018-27174 Filed 12-14-18; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 82, Number 236 (Monday, December 11, 2017)]
[Notices]
[Pages 58253-58257]
[FR Doc No: 2017-26583]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2017-0235]

Qualification of Drivers; Exemption Applications; Diabetes
Mellitus

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

ACTION: Notice of applications for exemption; request for comments.

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SUMMARY: FMCSA announces receipt of applications from 27 individuals
for an exemption from the prohibition in the Federal Motor Carrier
Safety Regulations (FMCSRs) against persons with insulin-treated
diabetes mellitus (ITDM) operating a commercial motor vehicle (CMV) in
interstate commerce. If granted, the exemptions would enable these
individuals with ITDM to operate CMVs in interstate commerce.

DATES: Comments must be received on or before January 10, 2018.

ADDRESSES: You may submit comments bearing the Federal Docket
Management System (FDMS) Docket No. FMCSA-2017-0235 using any of the
following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the online instructions for submitting
comments.
     Mail: Docket Management Facility; 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, between 9 a.m. and 5 p.m.,
ET, Monday through Friday, except Federal Holidays.
     Fax: 1-202-493-2251.
    Instructions: Each submission must include the Agency name and the
docket number(s) for this notice. Note that all comments received will
be posted without change to http://www.regulations.gov, including any
personal information provided. Please see the Privacy Act heading below
for further information.
    Docket: For access to the docket to read background documents or
comments, go to http://www.regulations.gov at any time or Room W12-140
on the ground level of the West Building, 1200 New Jersey Avenue SE.,
Washington, DC, between 9 a.m. and 5 p.m., ET, Monday through Friday,
except Federal holidays. The FDMS is available 24 hours each day ET,
365 days each year. If you want acknowledgment that we received your
comments, please include a self-addressed, stamped envelope or postcard
or print the acknowledgement page that appears after submitting
comments online.
    Privacy Act: In accordance with 5 U.S.C. 553(c), DOT solicits
comments from the public to better inform its rulemaking process. DOT
posts these comments, without edit, including any personal information
the commenter provides, to http://www.regulations.gov, as described in
the system of records notice (DOT/ALL-14 FDMS), which can be reviewed
at http://www.dot.gov/privacy.

FOR FURTHER INFORMATION CONTACT: Ms. Christine A. Hydock, Chief,
Medical Programs Division,<PHONE_NUMBER>, [email protected], FMCSA,
Department of Transportation, 1200 New Jersey Avenue SE., Room W64-224,
Washington, DC 20590-0001. Office hours are 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 Docket
Services, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Background

    Under 49 U.S.C. 31136(e) and 31315, FMCSA may grant an exemption
from the FMCSRs for a five-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
statute also allows the Agency to renew exemptions at the end of the
five-year period. FMCSA grants exemptions from the FMCSRs for a two-
year period to align with the maximum duration of a driver's medical
certification.
    The 27 individuals listed in this notice have requested an
exemption from the diabetes prohibition in 49 CFR 391.41(b)(3).
Accordingly, the Agency will evaluate the qualifications of each
applicant to determine whether granting the exemption will achieve the
required level of safety mandated by statute.
    The physical qualification standard for drivers regarding diabetes
found in 49 CFR 391.41(b)(3) states that a person is physically
qualified to drive a CMV

if that person has no established medical history or clinical diagnosis
of diabetes mellitus currently requiring insulin for control. The
Agency established the current requirement for diabetes in 1970 because
several risk studies indicated that drivers with diabetes had a higher
rate of crash involvement than the general population.
    FMCSA established its diabetes exemption program, based on the
Agency's July 2000 study entitled ``A Report to Congress on the
Feasibility of a Program to Qualify Individuals with Insulin-Treated
Diabetes Mellitus to Operate in Interstate Commerce as Directed by the
Transportation Act for the 21st Century.'' The report concluded that a
safe and practicable protocol to allow some drivers with ITDM to
operate CMVs is feasible. The September 3, 2003 (68 FR 52441), Federal
Register notice in conjunction with the November 8, 2005 (70 FR 67777),
Federal Register notice provides the current protocol for allowing such
drivers to operate CMVs in interstate commerce.
    FMCSA notes that section 4129 of the Safe, Accountable, Flexible
and Efficient Transportation Equity Act: A Legacy for Users requires
the Secretary to revise its diabetes exemption program established on
September 3, 2003 (68 FR 52441). The revision must provide for
individual assessment of drivers with diabetes mellitus, and be
consistent with the criteria described in section 4018 of the
Transportation Equity Act for the 21st Century (49 U.S.C. 31305).
Section 4129 requires: (1) Elimination of the requirement for three
years of experience operating CMVs while being treated with insulin;
and (2) establishment of a specified minimum period of insulin use to
demonstrate stable control of diabetes before being allowed to operate
a CMV.
    In response to section 4129, FMCSA made immediate revisions to the
diabetes exemption program established by the September 3, 2003 notice.
FMCSA discontinued use of the three-year driving experience and
fulfilled the requirements of section 4129 while continuing to ensure
that operation of CMVs by drivers with ITDM will achieve the requisite
level of safety required of all exemptions granted under 49 U.S.C.
31136(e). Section 4129(d) also directed FMCSA to ensure that drivers of
CMVs with ITDM are not held to a higher standard than other drivers,
with the exception of limited operating, monitoring and medical
requirements that are deemed medically necessary. The FMCSA concluded
that all of the operating, monitoring and medical requirements set out
in the September 3, 2003, notice, except as modified, were in
compliance with section 4129(d). Therefore, all of the requirements set
out in the September 3, 2003, notice, except as modified by the notice
in the Federal Register on November 8, 2005 (70 FR 67777), remain in
effect.

II. Qualifications of Applicants

Larry L. Alirez

    Mr. Alirez, 60, has had ITDM since 2010. His endocrinologist
examined him in 2017 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (two or more) severe hypoglycemic episodes in the last five
years. His endocrinologist certifies that Mr. Alirez understands
diabetes management and monitoring, has stable control of his diabetes
using insulin, and is able to drive a CMV safely. Mr. Alirez meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2017 and certified that he does not have
diabetic retinopathy. He holds a Class B CDL from New Mexico.

Samuel L. Boothe

    Mr. Boothe, 64, has had ITDM since 2017. His endocrinologist
examined him in 2017 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (two or more) severe hypoglycemic episodes in the last five
years. His endocrinologist certifies that Mr. Boothe understands
diabetes management and monitoring, has stable control of his diabetes
using insulin, and is able to drive a CMV safely. Mr. Boothe meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
ophthalmologist examined him in 2017 and certified that he has stable
nonproliferative diabetic retinopathy. He holds a Class A CDL from
Missouri.

Edward C. Carlson

    Mr. Carlson, 71, has had ITDM since 2010. His endocrinologist
examined him in 2017 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (two or more) severe hypoglycemic episodes in the last five
years. His endocrinologist certifies that Mr. Carlson understands
diabetes management and monitoring, has stable control of his diabetes
using insulin, and is able to drive a CMV safely. Mr. Carlson meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
ophthalmologist examined him in 2017 and certified that he does not
have diabetic retinopathy. He holds a Class B CDL from Massachusetts.

Andrew W. Carstens

    Mr. Carstens, 46, has had ITDM since 2017. His endocrinologist
examined him in 2017 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (two or more) severe hypoglycemic episodes in the last five
years. His endocrinologist certifies that Mr. Carstens understands
diabetes management and monitoring, has stable control of his diabetes
using insulin, and is able to drive a CMV safely. Mr. Carstens meets
the requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2017 and certified that he does not have
diabetic retinopathy. He holds a Class A CDL from Indiana.

Timothy R. Conaway

    Mr. Conaway, 62, has had ITDM since 2017. His endocrinologist
examined him in 2017 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (two or more) severe hypoglycemic episodes in the last five
years. His endocrinologist certifies that Mr. Conaway understands
diabetes management and monitoring, has stable control of his diabetes
using insulin, and is able to drive a CMV safely. Mr. Conaway meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
ophthalmologist examined him in 2017 and certified that he does not
have diabetic retinopathy. He holds a Class C CDL from Delaware.

Ronald E. Cope, Sr.

    Mr. Cope, 78, has had ITDM since 2004. His endocrinologist examined
him in 2017 and certified that he has had no severe hypoglycemic
reactions resulting in loss of consciousness, requiring the assistance
of another person, or

resulting in impaired cognitive function that occurred without warning
in the past 12 months and no recurrent (two or more) severe
hypoglycemic episodes in the last five years. His endocrinologist
certifies that Mr. Cope understands diabetes management and monitoring,
has stable control of his diabetes using insulin, and is able to drive
a CMV safely. Mr. Cope meets the requirements of the vision standard at
49 CFR 391.41(b)(10). His ophthalmologist examined him in 2017 and
certified that he does not have diabetic retinopathy. He holds an
operator's license from Tennessee.

Jeffrey Dockhorn

    Mr. Dockhorn, 59, has had ITDM since 2016. His endocrinologist
examined him in 2017 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (two or more) severe hypoglycemic episodes in the last five
years. His endocrinologist certifies that Mr. Dockhorn understands
diabetes management and monitoring, has stable control of his diabetes
using insulin, and is able to drive a CMV safely. Mr. Dockhorn meets
the requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2017 and certified that he does not have
diabetic retinopathy. He holds an operator's license from New Jersey.

Elias O. Eniade

    Mr. Eniade, 60, has had ITDM since 2014. His endocrinologist
examined him in 2017 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (two or more) severe hypoglycemic episodes in the last five
years. His endocrinologist certifies that Mr. Eniade understands
diabetes management and monitoring, has stable control of his diabetes
using insulin, and is able to drive a CMV safely. Mr. Eniade meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
ophthalmologist examined him in 2017 and certified that he has stable
nonproliferative diabetic retinopathy. He holds an operator's license
from Missouri.

Michael L. Evans

    Mr. Evans, 53, has had ITDM since 2010. His endocrinologist
examined him in 2017 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (two or more) severe hypoglycemic episodes in the last five
years. His endocrinologist certifies that Mr. Evans understands
diabetes management and monitoring, has stable control of his diabetes
using insulin, and is able to drive a CMV safely. Mr. Evans meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2017 and certified that he does not have
diabetic retinopathy. He holds an operator's license from Indiana.

Billy E. Hickman, Jr.

    Mr. Hickman, 34, has had ITDM since 2013. His endocrinologist
examined him in 2017 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (two or more) severe hypoglycemic episodes in the last five
years. His endocrinologist certifies that Mr. Hickman understands
diabetes management and monitoring, has stable control of his diabetes
using insulin, and is able to drive a CMV safely. Mr. Hickman meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2017 and certified that he does not have
diabetic retinopathy. He holds an operator's license from Missouri.

Lejuan K. Holmes

    Mr. Holmes, 46, has had ITDM since 1986. His endocrinologist
examined him in 2017 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (two or more) severe hypoglycemic episodes in the last five
years. His endocrinologist certifies that Mr. Holmes understands
diabetes management and monitoring, has stable control of his diabetes
using insulin, and is able to drive a CMV safely. Mr. Holmes meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
ophthalmologist examined him in 2017 and certified that he has stable
nonproliferative diabetic retinopathy. He holds a Class A CDL from
Texas.

Roy J. McDonald

    Mr. McDonald, 71, has had ITDM since 2011. His endocrinologist
examined him in 2017 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (two or more) severe hypoglycemic episodes in the last five
years. His endocrinologist certifies that Mr. McDonald understands
diabetes management and monitoring, has stable control of his diabetes
using insulin, and is able to drive a CMV safely. Mr. McDonald meets
the requirements of the vision standard at 49 CFR 391.41(b)(10). His
ophthalmologist examined him in 2017 and certified that he does not
have diabetic retinopathy. He holds a Class B CDL from New York.

Michael D. Mook

    Mr. Mook, 56, has had ITDM since 2016. His endocrinologist examined
him in 2017 and certified that he has had no severe hypoglycemic
reactions resulting in loss of consciousness, requiring the assistance
of another person, or resulting in impaired cognitive function that
occurred without warning in the past 12 months and no recurrent (two or
more) severe hypoglycemic episodes in the last five years. His
endocrinologist certifies that Mr. Mook understands diabetes management
and monitoring, has stable control of his diabetes using insulin, and
is able to drive a CMV safely. Mr. Mook meets the requirements of the
vision standard at 49 CFR 391.41(b)(10). His ophthalmologist examined
him in 2017 and certified that he has stable nonproliferative diabetic
retinopathy. He holds a Class A CDL from Iowa.

Nathon J. Owens

    Mr. Owens, 41, has had ITDM since 1989. His endocrinologist
examined him in 2017 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (two or more) severe hypoglycemic episodes in the last five
years. His endocrinologist certifies that Mr. Owens understands
diabetes management and monitoring, has stable control of his diabetes
using insulin, and is able to drive a CMV

safely. Mr. Owens meets the requirements of the vision standard at 49
CFR 391.41(b)(10). His optometrist examined him in 2017 and certified
that he does not have diabetic retinopathy. He holds an operator's
license from Indiana.

Guy K. Paquette

    Mr. Paquette, 57, has had ITDM since 2017. His endocrinologist
examined him in 2017 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (two or more) severe hypoglycemic episodes in the last five
years. His endocrinologist certifies that Mr. Paquette understands
diabetes management and monitoring, has stable control of his diabetes
using insulin, and is able to drive a CMV safely. Mr. Paquette meets
the requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2017 and certified that he does not have
diabetic retinopathy. He holds a Class B CDL from Minnesota.

Robert C. Payne

    Mr. Payne, 57, has had ITDM since 2003. His endocrinologist
examined him in 2017 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (two or more) severe hypoglycemic episodes in the last five
years. His endocrinologist certifies that Mr. Payne understands
diabetes management and monitoring, has stable control of his diabetes
using insulin, and is able to drive a CMV safely. Mr. Payne meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
ophthalmologist examined him in 2017 and certified that he has stable
proliferative diabetic retinopathy. He holds a Class A CDL from
Virginia.

Lyle S. Pearson

    Mr. Pearson, 54, has had ITDM since 2016. His endocrinologist
examined him in 2017 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (two or more) severe hypoglycemic episodes in the last five
years. His endocrinologist certifies that Mr. Pearson understands
diabetes management and monitoring, has stable control of his diabetes
using insulin, and is able to drive a CMV safely. Mr. Pearson meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2017 and certified that he does not have
diabetic retinopathy. He holds a Class B CDL from Illinois.

Joseph M. Pellish, Jr.

    Mr. Pellish, 59, has had ITDM since 2017. His endocrinologist
examined him in 2017 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (two or more) severe hypoglycemic episodes in the last five
years. His endocrinologist certifies that Mr. Pellish understands
diabetes management and monitoring, has stable control of his diabetes
using insulin, and is able to drive a CMV safely. Mr. Pellish meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
ophthalmologist examined him in 2017 and certified that he does not
have diabetic retinopathy. He holds a Class A CDL from Minnesota.

Daniel R. Plecki

    Mr. Plecki, 28, has had ITDM since 2015. His endocrinologist
examined him in 2017 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (two or more) severe hypoglycemic episodes in the last five
years. His endocrinologist certifies that Mr. Plecki understands
diabetes management and monitoring, has stable control of his diabetes
using insulin, and is able to drive a CMV safely. Mr. Plecki meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2017 and certified that he does not have
diabetic retinopathy. He holds a Class B CDL from Illinois.

Victor H. Pulgarin-Gomez

    Mr. Pulgarin-Gomez, 32, has had ITDM since 2008. His
endocrinologist examined him in 2017 and certified that he has had no
severe hypoglycemic reactions resulting in loss of consciousness,
requiring the assistance of another person, or resulting in impaired
cognitive function that occurred without warning in the past 12 months
and no recurrent (two or more) severe hypoglycemic episodes in the last
five years. His endocrinologist certifies that Mr. Pulgarin-Gomez
understands diabetes management and monitoring, has stable control of
his diabetes using insulin, and is able to drive a CMV safely. Mr.
Pulgarin-Gomez meets the requirements of the vision standard at 49 CFR
391.41(b)(10). His optometrist examined him in 2017 and certified that
he does not have diabetic retinopathy. He holds a Class A CDL from New
Jersey.

Stephen D. Reintsma

    Mr. Reintsma, 49, has had ITDM since 2017. His endocrinologist
examined him in 2017 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (two or more) severe hypoglycemic episodes in the last five
years. His endocrinologist certifies that Mr. Reintsma understands
diabetes management and monitoring, has stable control of his diabetes
using insulin, and is able to drive a CMV safely. Mr. Reintsma meets
the requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2017 and certified that he does not have
diabetic retinopathy. He holds a Class A CDL from Iowa.

Charles W. Wakefield

    Mr. Wakefield, 58, has had ITDM since 2016. His endocrinologist
examined him in 2017 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (two or more) severe hypoglycemic episodes in the last five
years. His endocrinologist certifies that Mr. Wakefield understands
diabetes management and monitoring, has stable control of his diabetes
using insulin, and is able to drive a CMV safely. Mr. Wakefield meets
the requirements of the vision standard at 49 CFR 391.41(b)(10). His
ophthalmologist examined him in 2017 and certified that he does not
have diabetic retinopathy. He holds a Class A CDL from Mississippi.

John L. Whitehead, Jr.

    Mr. Whitehead, 54, has had ITDM since 2017. His endocrinologist
examined him in 2017 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that

occurred without warning in the past 12 months and no recurrent (two or
more) severe hypoglycemic episodes in the last five years. His
endocrinologist certifies that Mr. Whitehead understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Whitehead meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2017 and certified that he does not have
diabetic retinopathy. He holds a Class A CDL from Tennessee.

Keith L. Wilson

    Mr. Wilson, 47, has had ITDM since 2011. His endocrinologist
examined him in 2017 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (two or more) severe hypoglycemic episodes in the last five
years. His endocrinologist certifies that Mr. Wilson understands
diabetes management and monitoring, has stable control of his diabetes
using insulin, and is able to drive a CMV safely. Mr. Wilson meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2017 and certified that he does not have
diabetic retinopathy. He holds an operator's license from Wisconsin.

Adam J. Writz

    Mr. Writz, 30, has had ITDM since 2015. His endocrinologist
examined him in 2017 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (two or more) severe hypoglycemic episodes in the last five
years. His endocrinologist certifies that Mr. Writz understands
diabetes management and monitoring, has stable control of his diabetes
using insulin, and is able to drive a CMV safely. Mr. Writz meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2017 and certified that he does not have
diabetic retinopathy. He holds an operator's license from Idaho.

Rave Y. Yarron

    Mr. Yarron, 39, has had ITDM since 2017. His endocrinologist
examined him in 2017 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (two or more) severe hypoglycemic episodes in the last five
years. His endocrinologist certifies that Mr. Yarron understands
diabetes management and monitoring, has stable control of his diabetes
using insulin, and is able to drive a CMV safely. Mr. Yarron meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2017 and certified that he does not have
diabetic retinopathy. He holds a Class A CDL from Maryland.

Willie C. Young

    Mr. Young, 58, has had ITDM since 2016. His endocrinologist
examined him in 2017 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (two or more) severe hypoglycemic episodes in the last five
years. His endocrinologist certifies that Mr. Young understands
diabetes management and monitoring, has stable control of his diabetes
using insulin, and is able to drive a CMV safely. Mr. Young meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2017 and certified that he does not have
diabetic retinopathy. He holds a Class A CDL from Texas.

III. Request for Comments

    In accordance with 49 U.S.C. 31136(e) and 31315, FMCSA requests
public comment from all interested persons on the exemption petitions
described in this notice. We will consider all comments received before
the close of business on the closing date indicated in the dates
section of the notice.

IV. Submitting Comments

    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 http://www.regulations.gov and
in the search box insert the docket number FMCSA-2017-0235 and click
the search button. When the new screen appears, click on the blue
``Comment Now!'' button on the right hand side of the page. On the new
page, enter information required including the specific section of this
document to which each comment applies, and provide a reason for each
suggestion or recommendation. 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. If you submit
comments by mail and would like to know that they reached the facility,
please enclose a stamped, self-addressed postcard or envelope.
    We will consider all comments and materials received during the
comment period. FMCSA may issue a final determination at any time after
the close of the comment period.

V. Viewing Comments and Documents

    To view comments, as well as any documents mentioned in this
preamble, go to http://www.regulations.gov and in the search box insert
the docket number FMCSA-2017-0235 and click ``Search.'' Next, click
``Open Docket Folder'' and you will find all documents and comments
related to this notice.

    Issued on: December 4, 2017.
Larry W. Minor,
Associate Administrator for Policy.
[FR Doc. 2017-26583 Filed 12-8-17; 8:45 am]
 BILLING CODE 4910-EX-P


[Federal Register: July 19, 2010 (Volume 75, Number 137)]
[Notices]
[Page 41926-41927]
[DOCID:fr19jy10-135]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Noise Exposure Map Notice New Smyrna Beach Municipal Airport, New
Smyrna Beach, FL

AGENCY: Federal Aviation Administration, DOT.

ACTION: Notice.

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

SUMMARY: The Federal Aviation Administration (FAA) announces its
determination that the Noise Exposure Maps submitted by the City of New
Smyrna Beach for New Smyrna Beach Municipal Airport under the
provisions of 49 U.S.C. 47501 et seq. (Aviation Safety and Noise
Abatement Act) and 14 CFR Part 150 are in compliance with applicable
requirements.

DATES: Effective Date: The effective date of the FAA's determination on
the noise exposure maps is July 8, 2010.

FOR FURTHER INFORMATION CONTACT: Ms. Lindy McDowell, Federal Aviation
Administration, Orlando Airports District Office, 5950 Hazeltine
National Drive, Suite 400, Orlando, FL 32822,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: This notice announces that the FAA finds
that the Noise Exposure Maps submitted for New Smyrna Beach Municipal
Airport are in compliance with applicable requirements of Title 14 Code
of Federal Regulations (CFR) Part 150, effective July 8, 2010. Under 49
U.S.C. section 47503 of the Aviation Safety and Noise Abatement Act
(the Act), an airport operator may submit to the FAA Noise Exposure
Maps which meet applicable regulations and which depict non-compatible
land uses as of the date of submission of such maps, a description of
projected aircraft operations, and the ways in which such operations
will affect such maps. The Act requires such maps to be developed in
consultation with interested and affected parties in the local
community, government agencies, and persons using the airport. An
airport operator who has submitted Noise Exposure Maps that are found
by FAA to be in compliance with the requirements of 14 CFR Part 150,
promulgated pursuant to the Act, may submit a Noise Compatibility
Program for FAA approval which sets forth the measures the airport
operator has taken or proposes to take to reduce existing non-
compatible uses and prevent the introduction of additional non-
compatible uses.
    The FAA has completed its review of the Noise Exposure Maps and
accompanying documentation submitted by the City of New Smyrna Beach.
The documentation that constitutes the ``Noise Exposure Maps'' as
defined in Section 150.7 of 14 CFR Part 150 includes: Figure 6.1, 2009
Noise Contours; Figure 6.2, 2014 Noise Contours; Figure 5-1, Runway 02
Flight Tracks; Figure 5-2, Runway 07 Flight Tracks; Figure 5-3, Runway
11 Flight Tracks; Figure 5-4, Runway 20 Flight Tracks; Figure 5-5,
Runway 25 Flight Tracks; Figure 5-6, Runway 29 Flight Tracks; Figure
5.7, Helicopter Flight Tracks, Figure 5.8 Local Flight Tracks; Table
5.1, 2008 Annual Operations; Table 5.2, 2008 Annual-Average Day Fleet
Mix (Itinerant Operations); Table 5.3, 2008 Annual Average Day Fleet
Mix (Local Operations); Table 5.4 2013 Annual Operations; Table 5.5,
2013 Annual-Average Day Fleet Mix (Itinerant Operations); Table 5.6,
2013 Annual Average Day Fleet Mix (Local Operations); Figure 5.10,
Percentage Runway Utilization; and Table 5.11,

Percentage Helicopter Runway/Helipad Utilization. The FAA has
determined that these Noise Exposure Maps and accompanying
documentation are in compliance with applicable requirements. This
determination is effective on July 8, 2010.
    FAA's determination on the airport operator's Noise Exposure Maps
is limited to a finding that the maps were developed in accordance with
the procedures contained in Appendix A of 14 CFR Part 150. Such
determination does not constitute approval of the airport operator's
data, information or plans, or a commitment to approve a Noise
Compatibility Program or to fund the implementation of that Program. If
questions arise concerning the precise relationship of specific
properties to noise exposure contours depicted on a Noise Exposure Map
submitted under Section 47503 of the Act, it should be noted that the
FAA is not involved in any way in determining the relative locations of
specific properties with regard to the depicted noise exposure
contours, or in interpreting the Noise Exposure Maps to resolve
questions concerning, for example, which properties should be covered
by the provisions of Section 47506 of the Act. These functions are
inseparable from the ultimate land use control and planning
responsibilities of local government. These local responsibilities are
not changed in any way under 14 CFR Part 150 or through FAA's review of
Noise Exposure Maps. Therefore, the responsibility for the detailed
overlaying of noise exposure contours onto the map depicting properties
on the surface rests exclusively with the airport operator that
submitted those maps, or with those public agencies and planning
agencies with which consultation is required under Section 47503 of the
Act. The FAA has relied on the certification by the airport operator,
under Section 150.21 of 14 CFR Part 150, that the statutorily required
consultation has been accomplished.
    Copies of the full Noise Exposure Maps documentation and of the
FAA's evaluation of the maps are available for examination at the
following location: Federal Aviation Administration, Orlando Airports
District Office, 5950 Hazeltine National Drive, Suite 400, Orlando, FL
32822,<PHONE_NUMBER>.
    Questions may be directed to the individual named above under the
heading, FOR FURTHER INFORMATION CONTACT.

    Issued in Orlando, Florida, on July 8, 2010.
W. Dean Stringer,
Manager, Orlando Airports District Office.
[FR Doc. 2010-17512 Filed 7-16-10; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 83, Number 173 (Thursday, September 6, 2018)]
[Notices]
[Pages 45266-45267]
[FR Doc No: 2018-19327]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

[Docket No. USCG-2018-0789]

Information Collection Request to Office of Management and
Budget; OMB Control Number: 625-0069

AGENCY: Coast Guard, DHS.

ACTION: Sixty-day notice requesting comments.

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SUMMARY: In compliance with the Paperwork Reduction Act of 1995, the
U.S. Coast Guard intends to submit an Information Collection Request
(ICR) to the Office of Management and Budget (OMB), Office of
Information and Regulatory Affairs (OIRA), requesting an extension of
its approval for the following collection of information: 1625-0069,
Ballast Water Management Reporting and Recordkeeping; without change.
Our ICR describes the information we seek to collect from the public.
Before submitting this ICR to OIRA, the Coast Guard is inviting
comments as described below.

DATES: Comments must reach the Coast Guard on or before November 5,
2018.

ADDRESSES: You may submit comments identified by Coast Guard docket
number [USCG-2018-0789] to the Coast Guard using the Federal
eRulemaking Portal at http://www.regulations.gov. See the ``Public
participation and request for comments'' portion of the SUPPLEMENTARY
INFORMATION section for further instructions on submitting comments.
    A copy of the ICR is available through the docket on the internet
at http://www.regulations.gov. Additionally, copies are available from:
Commandant (CG-612), ATTN: Paperwork Reduction Act Manager, U.S. Coast
Guard, 2703 Martin Luther King Jr. Ave SE, Stop 7710, Washington, DC
20593-7710.

FOR FURTHER INFORMATION CONTACT: Mr. Anthony Smith, Office of
Information Management, telephone<PHONE_NUMBER>, or fax<PHONE_NUMBER>,
for questions on these documents.

SUPPLEMENTARY INFORMATION:

Public Participation and Request for Comments

    This notice relies on the authority of the Paperwork Reduction Act
of 1995; 44 U.S.C. Chapter 35, as amended. An ICR is an application to
OIRA seeking the approval, extension, or renewal of a Coast Guard
collection of information (Collection). The ICR contains information
describing the Collection's purpose, the Collection's likely burden on
the affected public, an explanation of the necessity of the Collection,
and other important information describing the Collection. There is one
ICR for each Collection.
    The Coast Guard invites comments on whether this ICR should be
granted based on the Collection being necessary for the proper
performance of Departmental functions. In particular, the Coast Guard
would appreciate comments addressing: (1) The practical utility of the
Collection; (2) the accuracy of the estimated burden of the Collection;
(3) ways to enhance the quality, utility, and clarity of information
subject to the Collection; and (4) ways to minimize the burden of the
Collection on respondents, including the use of automated collection
techniques or other forms of information technology. In response to
your comments, we may revise this ICR or decide not to seek an
extension of approval for the Collection. We will consider all comments
and material received during the comment period.
    We encourage you to respond to this request by submitting comments
and related materials. Comments must contain the OMB Control Number of
the ICR and the docket number of this request, [USCG-2018-0789], and
must be received by November 5, 2018.

Submitting Comments

    We encourage you to submit comments through the Federal eRulemaking
Portal at http://www.regulations.gov. If your material cannot be
submitted using http://www.regulations.gov, contact the person in the
FOR FURTHER INFORMATION CONTACT section of this document for alternate
instructions. Documents mentioned in this notice, and all public
comments, are in our online docket at http://www.regulations.gov and
can be viewed by following that website's instructions. Additionally,
if you go to the online docket and sign up for email alerts, you will
be notified when comments are posted.
    We accept anonymous comments. All comments received will be posted
without change to http://www.regulations.gov and will include any
personal information you have provided. For more about privacy and the
docket, you may review a Privacy Act notice regarding the Federal
Docket Management System in the March 24, 2005, issue of the Federal
Register (70 FR 15086).

Information Collection Request

    Title: Ballast Water Management Reporting and Recordkeeping.
    OMB Control Number: 1625-0069.

    Summary:This collection requires the master of a vessel to provide
information that details the vessel operator's ballast water management
efforts.
    Need: The information is needed to ensure compliance with 16 U.S.C.
4711 and the requirements in 33 CFR part 151, subparts C and D
regarding the management of ballast water, to prevent the introduction
and spread of aquatic nuisance species into U.S. waters. The
information is also used for research and periodic reporting to
Congress.
    Forms: Ballast Water Management Report and Ballast Water Management
(BWM) Equivalent Reporting Program Application.
    Respondents: Owners and operators of certain vessels.
    Frequency: On occasion.
    Hour Burden Estimate: The estimated burden has increased from
61,819 hours to 83,337 hours a year due to an increase in the estimated
annual number of responses.

    Authority: The Paperwork Reduction Act of 1995; 44 U.S.C.
Chapter 35, as amended.

    Dated: August 30, 2018.
James D. Roppel,
U.S. Coast Guard, Acting Chief, Office of Information Management.
[FR Doc. 2018-19327 Filed 9-5-18; 8:45 am]
 BILLING CODE 9110-04-P


[Federal Register Volume 88, Number 22 (Thursday, February 2, 2023)]
[Rules and Regulations]
[Pages 7007-7010]
[FR Doc No: 2023-02141]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 864

[Docket No. FDA-2023-N-0062]

Medical Devices; Hematology and Pathology Devices; Classification
of the Software Algorithm Device To Assist Users in Digital Pathology

AGENCY: Food and Drug Administration, HHS.

ACTION: Final amendment; final order.

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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is
classifying the software algorithm device to assist users in digital
pathology into class II (special controls). The special controls that
apply to the device type are identified in this order and will be part
of the codified language for the software algorithm device to assist
users in digital pathology's classification. We are taking this action
because we have determined that classifying the device into class II
(special controls) will provide a reasonable assurance of safety and
effectiveness of the device. We believe this action will also enhance
patients' access to beneficial innovative devices.

DATES: This order is effective February 2, 2023. The classification was
applicable on September 21, 2021.

FOR FURTHER INFORMATION CONTACT: Arpita Roy, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 3319, Silver Spring, MD 20993-0002,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    Upon request, FDA has classified the software algorithm device to
assist users in digital pathology as class II (special controls), which
we have determined will provide a reasonable assurance of safety and
effectiveness. In addition, we believe this action will enhance
patients' access to beneficial innovation, in part by placing the
device into a lower device class than the automatic class III
assignment.
    The automatic assignment of class III occurs by operation of law
and without any action by FDA, regardless of the level of risk posed by
the new device. Any device that was not in commercial distribution
before May 28, 1976, is automatically classified as, and remains
within, class III and requires premarket approval unless and until FDA
takes an action to classify or reclassify the device (see 21 U.S.C.
360c(f)(1)). We refer to these devices as ``postamendments devices''
because they were not in commercial distribution prior to the date of
enactment of the Medical Device Amendments of 1976, which amended the
Federal Food, Drug, and Cosmetic Act (FD&C Act).
    FDA may take a variety of actions in appropriate circumstances to
classify or reclassify a device into class I or II. We may issue an
order finding a new device to be substantially equivalent under section
513(i) of the FD&C Act (see 21

U.S.C. 360c(i)) to a predicate device that does not require premarket
approval. We determine whether a new device is substantially equivalent
to a predicate device by means of the procedures for premarket
notification under section 510(k) of the FD&C Act (21 U.S.C. 360(k))
and part 807 (21 CFR part 807).
    FDA may also classify a device through ``De Novo'' classification,
a common name for the process authorized under section 513(f)(2) of the
FD&C Act. Section 207 of the Food and Drug Administration Modernization
Act of 1997 (Pub. L. 105-115) established the first procedure for De
Novo classification. Section 607 of the Food and Drug Administration
Safety and Innovation Act (Pub. L. 112-144) modified the De Novo
application process by adding a second procedure. A device sponsor may
utilize either procedure for De Novo classification.
    Under the first procedure, the person submits a 510(k) for a device
that has not previously been classified. After receiving an order from
FDA classifying the device into class III under section 513(f)(1) of
the FD&C Act, the person then requests a classification under section
513(f)(2).
    Under the second procedure, rather than first submitting a 510(k)
and then a request for classification, if the person determines that
there is no legally marketed device upon which to base a determination
of substantial equivalence, that person requests a classification under
section 513(f)(2) of the FD&C Act.
    Under either procedure for De Novo classification, FDA is required
to classify the device by written order within 120 days. The
classification will be according to the criteria under section
513(a)(1) of the FD&C Act. Although the device was automatically placed
within class III, the De Novo classification is considered to be the
initial classification of the device.
    When FDA classifies a device into class I or II via the De Novo
process, the device can serve as a predicate for future devices of that
type, including for 510(k)s (see section 513(f)(2)(B)(i) of the FD&C
Act). As a result, other device sponsors do not have to submit a De
Novo request or premarket approval application to market a
substantially equivalent device (see section 513(i) of the FD&C Act,
defining ``substantial equivalence''). Instead, sponsors can use the
less-burdensome 510(k) process, when necessary, to market their device.

II. De Novo Classification

    On December 31, 2020, FDA received Paige.AI, Inc.'s request for De
Novo classification of the Paige Prostate. FDA reviewed the request in
order to classify the device under the criteria for classification set
forth in section 513(a)(1) of the FD&C Act.
    We classify devices into class II if general controls by themselves
are insufficient to provide reasonable assurance of safety and
effectiveness, but there is sufficient information to establish special
controls that, in combination with the general controls, provide
reasonable assurance of the safety and effectiveness of the device for
its intended use (see 21 U.S.C. 360c(a)(1)(B)). After review of the
information submitted in the request, we determined that the device can
be classified into class II with the establishment of special controls.
FDA has determined that these special controls, in addition to the
general controls, will provide reasonable assurance of the safety and
effectiveness of the device.
    Therefore, on September 21, 2021, FDA issued an order to the
requester classifying the device into class II. In this final order,
FDA is codifying the classification of the device by adding 21 CFR
864.3750.\1\ We have named the generic type of device software
algorithm device to assist users in digital pathology, and it is
identified as an in vitro diagnostic device intended to evaluate
acquired scanned pathology whole slide images. The device uses software
algorithms to provide information to the user about presence, location,
and characteristics of areas of the image with clinical implications.
Information from this device is intended to assist the user in
determining a pathology diagnosis.
---------------------------------------------------------------------------

    \1\ FDA notes that the ``ACTION'' caption for this final order
is styled as ``Final amendment; final order,'' rather than ``Final
order.'' Beginning in December 2019, this editorial change was made
to indicate that the document ``amends'' the Code of Federal
Regulations. The change was made in accordance with the Office of
Federal Register's (OFR) interpretations of the Federal Register Act
(44 U.S.C. chapter 15), its implementing regulations (1 CFR 5.9 and
parts 21 and 22), and the Document Drafting Handbook.
---------------------------------------------------------------------------

    FDA has identified the following risks to health associated
specifically with this type of device and the measures required to
mitigate these risks in table 1.

 Table 1--Software Algorithm Device To Assist Users in Digital Pathology
                      Risks and Mitigation Measures
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       Identified risks                   Mitigation measures
------------------------------------------------------------------------
False negative classification  Certain design verification and
 (loss of accuracy).            validation, including certain device
                                descriptions, certain analytical
                                studies, and clinical studies; and
                               Certain labeling information, including
                                certain device descriptions, certain
                                performance information, and certain
                                limitations.
False positive classification  Certain design verification and
 (loss of accuracy).            validation, including certain device
                                descriptions, certain analytical
                                studies, and clinical studies; and
                               Certain labeling information, including
                                certain device descriptions, certain
                                performance information, and certain
                                limitations.
------------------------------------------------------------------------

    FDA has determined that special controls, in combination with the
general controls, address these risks to health and provide reasonable
assurance of safety and effectiveness. For a device to fall within this
classification, and thus avoid automatic classification in class III,
it would have to comply with the special controls named in this final
order. The necessary special controls appear in the regulation codified
by this order. This device is subject to premarket notification
requirements under section 510(k) of the FD&C Act.

III. Analysis of Environmental Impact

    The Agency has determined under 21 CFR 25.34(b) that this action is
of a type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.

IV. Paperwork Reduction Act of 1995

    This final order establishes special controls that refer to
previously approved collections of information found in other FDA
regulations and

guidance. These collections of information are subject to review by the
Office of Management and Budget (OMB) under the Paperwork Reduction Act
of 1995 (44 U.S.C. 3501-3521). The collections of information in 21 CFR
part 860, subpart D, regarding De Novo classification have been
approved under OMB control number 0910-0844; the collections of
information in 21 CFR part 814, subparts A through E, regarding
premarket approval, have been approved under OMB control number 0910-
0231; the collections of information in part 807, subpart E, regarding
premarket notification submissions, have been approved under OMB
control number 0910-0120; the collections of information in 21 CFR part
820, regarding quality system regulation, have been approved under OMB
control number 0910-0073; and the collections of information in 21 CFR
parts 801and 809, regarding labeling, have been approved under OMB
control number 0910-0485.

List of Subjects in 21 CFR Part 864

    Blood, Medical devices, and Packaging and containers.
    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
864 is amended as follows:

PART 864--HEMATOLOGY AND PATHOLOGY DEVICES

0
1. The authority citation for part 864 continues to read as follows:

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.

0
2. Add Sec.  864.3750 to subpart D to read as follows:

Sec.  864.3750  Software algorithm device to assist users in digital
pathology.

    (a) Identification. A software algorithm device to assist users in
digital pathology is an in vitro diagnostic device intended to evaluate
acquired scanned pathology whole slide images. The device uses software
algorithms to provide information to the user about presence, location,
and characteristics of areas of the image with clinical implications.
Information from this device is intended to assist the user in
determining a pathology diagnosis.
    (b) Classification. Class II (special controls). The special
controls for this device are:
    (1) The intended use on the device's label and labeling required
under Sec.  809.10 of this chapter must include:
    (i) Specimen type;
    (ii) Information on the device input(s) (e.g., scanned whole slide
images (WSI), etc.);
    (iii) Information on the device output(s) (e.g., format of the
information provided by the device to the user that can be used to
evaluate the WSI, etc.);
    (iv) Intended users;
    (v) Necessary input/output devices (e.g., WSI scanners, viewing
software, etc.);
    (vi) A limiting statement that addresses use of the device as an
adjunct; and
    (vii) A limiting statement that users should use the device in
conjunction with complete standard of care evaluation of the WSI.
    (2) The labeling required under Sec.  809.10(b) of this chapter
must include:
    (i) A detailed description of the device, including the following:
    (A) Detailed descriptions of the software device, including the
detection/analysis algorithm, software design architecture, interaction
with input/output devices, and necessary third-party software;
    (B) Detailed descriptions of the intended user(s) and recommended
training for safe use of the device; and
    (C) Clear instructions about how to resolve device-related issues
(e.g., cybersecurity or device malfunction issues).
    (ii) A detailed summary of the performance testing, including test
methods, dataset characteristics, results, and a summary of sub-
analyses on case distributions stratified by relevant confounders, such
as anatomical characteristics, patient demographics, medical history,
user experience, and scanning equipment, as applicable.
    (iii) Limiting statements that indicate:
    (A) A description of situations in which the device may fail or may
not operate at its expected performance level (e.g., poor image quality
or for certain subpopulations), including any limitations in the
dataset used to train, test, and tune the algorithm during device
development;
    (B) The data acquired using the device should only be interpreted
by the types of users indicated in the intended use statement; and
    (C) Qualified users should employ appropriate procedures and
safeguards (e.g., quality control measures, etc.) to assure the
validity of the interpretation of images obtained using this device.
    (3) Design verification and validation must include:
    (i) A detailed description of the device software, including its
algorithm and its development, that includes a description of any
datasets used to train, tune, or test the software algorithm. This
detailed description of the device software must include:
    (A) A detailed description of the technical performance assessment
study protocols (e.g., regions of interest (ROI) localization study)
and results used to assess the device output(s) (e.g., image overlays,
image heatmaps, etc.);
    (B) The training dataset must include cases representing different
pre-analytical variables representative of the conditions likely to be
encountered when used as intended (e.g., fixation type and time,
histology slide processing techniques, challenging diagnostic cases,
multiple sites, patient demographics, etc.);
    (C) The number of WSI in an independent validation dataset must be
appropriate to demonstrate device accuracy in detecting and localizing
ROIs on scanned WSI, and must include subsets clinically relevant to
the intended use of the device;
    (D) Emergency recovery/backup functions, which must be included in
the device design;
    (E) System level architecture diagram with a matrix to depict the
communication endpoints, communication protocols, and security
protections for the device and its supportive systems, including any
products or services that are included in the communication pathway;
and
    (F) A risk management plan, including a justification of how the
cybersecurity vulnerabilities of third-party software and services are
reduced by the device's risk management mitigations in order to address
cybersecurity risks associated with key device functionality (such as
loss of image, altered metadata, corrupted image data, degraded image
quality, etc.). The risk management plan must also include how the
device will be maintained on its intended platform (e.g. a general
purpose computing platform, virtual machine, middleware, cloud-based
computing services, medical device hardware, etc.), which includes how
the software integrity will be maintained, how the software will be
authenticated on the platform, how any reliance on the platform will be
managed in order to facilitate implementation of cybersecurity controls
(such as user authentication, communication encryption and
authentication, etc.), and how the device will be protected when the
underlying platform is not updated, such that the specific risks of the
device are addressed (such as loss of image, altered metadata,
corrupted image data, degraded image quality, etc.).
    (ii) Data demonstrating acceptable, as determined by FDA,
analytical device

performance, by conducting analytical studies. For each analytical
study, relevant details must be documented (e.g., the origin of the
study slides and images, reader/annotator qualifications, method of
annotation, location of the study site(s), challenging diagnoses,
etc.). The analytical studies must include:
    (A) Bench testing or technical testing to assess device output,
such as localization of ROIs within a pre-specified threshold. Samples
must be representative of the entire spectrum of challenging cases
likely to be encountered when the device is used as intended; and
    (B) Data from a precision study that demonstrates device
performance when used with multiple input devices (e.g., WSI scanners)
to assess total variability across operators, within-scanner, between-
scanner and between-site, using clinical specimens with defined,
clinically relevant, and challenging characteristics likely to be
encountered when the device is used as intended. Samples must be
representative of the entire spectrum of challenging cases likely to be
encountered when the device is used as intended. Precision, including
performance of the device and reproducibility, must be assessed by
agreement between replicates.
    (iii) Data demonstrating acceptable, as determined by FDA, clinical
validation must be demonstrated by conducting studies with clinical
specimens. For each clinical study, relevant details must be documented
(e.g., the origin of the study slides and images, reader/annotator
qualifications, method of annotation, location of the study site(s)
(on-site/remote), challenging diagnoses, etc.). The studies must
include:
    (A) A study demonstrating the performance by the intended users
with and without the software device (e.g., unassisted and device-
assisted reading of scanned WSI of pathology slides). The study dataset
must contain sufficient numbers of cases from relevant cohorts that are
representative of the scope of patients likely to be encountered given
the intended use of the device (e.g., subsets defined by clinically
relevant confounders, challenging diagnoses, subsets with potential
biopsy appearance modifiers, concomitant diseases, and subsets defined
by image scanning characteristics, etc.) such that the performance
estimates and confidence intervals for these individual subsets can be
characterized. The performance assessment must be based on appropriate
diagnostic accuracy measures (e.g., sensitivity, specificity,
predictive value, diagnostic likelihood ratio, etc.).
    (B) [Reserved]

    Dated: January 26, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-02141 Filed 2-1-23; 8:45 am]
BILLING CODE 4164-01-P