[Federal Register Volume 84, Number 190 (Tuesday, October 1, 2019)]
[Notices]
[Pages 52157-52159]
[FR Doc No: 2019-21280]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2008-0355; FMCSA-2012-0050; FMCSA-2013-0106; FMCSA-
2014-0214; FMCSA-2014-0381; FMCSA-2015-0115; FMCSA-2015-0117; FMCSA-
2017-0180]

Qualification of Drivers; Exemption Applications; Epilepsy and
Seizure Disorders

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

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

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SUMMARY: FMCSA announces its decision to renew exemptions for ten
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 October 31, 2019.

ADDRESSES: You may submit comments identified by the Federal Docket
Management System (FDMS) Docket No. FMCSA-2008-0355, Docket No. FMCSA-
2012-0050, Docket No. FMCSA-2013-0106, Docket No. FMCSA-2014-0214,
Docket No. FMCSA-2014-0381, Docket No. FMCSA-2015-0115, Docket No.
FMCSA-2015-0117, Docket No. FMCSA-2017-0180.
     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:<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,<PHONE_NUMBER><EMAIL_ADDRESS>FMCSA,
Department of Transportation, 1200 New Jersey Avenue SE, Room W64-224,
Washington, DC 20590-0001. 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 Docket 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-2008-0355, Docket No. FMCSA-2012-0050, Docket
No. FMCSA-2013-0106, Docket No. FMCSA-2014-0214, Docket No. FMCSA-2014-
0381, Docket No. FMCSA-2015-0115, Docket No. FMCSA-2015-0117, Docket
No. FMCSA-2017-0180), 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 http://www.regulations.gov,
put the docket number, FMCSA-2008-0355; FMCSA-2012-0050; FMCSA-2013-
0106; FMCSA-2014-0214; FMCSA-2014-0381; FMCSA-2015-0115; FMCSA-2015-
0117; FMCSA-2017-0180, in the keyword box, and click ``Search.'' When
the new screen appears, click on the ``Comment Now!'' 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. 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.
    FMCSA will consider all comments and material received during the
comment period.

B. Viewing Documents and Comments

    To view comments, as well as any documents mentioned in this notice
as being available in the docket, go to http://www.regulations.gov.
Insert the docket number, FMCSA-2008-0355; FMCSA-2012-0050; FMCSA-2013-
0106; FMCSA-2014-0214; FMCSA-2014-0381; FMCSA-2015-0115; FMCSA-2015-
0117; FMCSA-2017-0180, in the keyword box, and click ``Search.'' Next,
click the ``Open Docket Folder'' button and choose the document to
review. If you do not have access to the internet, you may view the
docket online by visiting the Docket Management Facility in Room W12-
140 on the ground floor of the DOT West Building, 1200 New Jersey
Avenue SE, Washington, DC 20590, between 9 a.m. and 5 p.m., ET, Monday
through Friday, except Federal holidays.

C. 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 www.regulations.gov, as described in the system
of records notice (DOT/ALL-14 FDMS), which can be reviewed at
www.dot.gov/privacy.

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 statute also allows the Agency to renew exemptions at
the end of the 5-year period. 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 (MEs) 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 ten 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 ten
applicants has satisfied the renewal conditions for obtaining an
exemption from the epilepsy and seizure disorders prohibition. The ten
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 September
and are discussed below.
    As of September 2, 2019, and in accordance with 49 U.S.C. 31136(e)
and 31315(b), the following individual has satisfied the renewal
conditions for obtaining an exemption from the epilepsy and seizure
disorders prohibition in the FMCSRs for interstate CMV driver: Daniel
Maben (MI).
    The driver was included in docket number FMCSA-2017-0180. Their
exemption is applicable as of September 2, 2019, and will expire on
September 2, 2021.
    As of September 12, 2019, and in accordance with 49 U.S.C. 31136(e)
and 31315(b), the following nine individuals have satisfied the renewal
conditions for obtaining an exemption from the epilepsy and seizure
disorders prohibition in the FMCSRs for interstate CMV drivers:

Ronald Boogay (NJ)
Todd W. Brock (CO)
Jason Kirkham (WI)
Ivan M. Martin (PA)
Charles A. McCarthy, III (MA)
Douglas S. Slagel (OH)
Cory R. Wagner (IL)
Timothy M. Zahratka (MN)

    The drivers were included in docket number FMCSA-2008-0355; FMCSA-
2012-0050; FMCSA-2013-0106; FMCSA-2014-0214; FMCSA-2014-0381; FMCSA-
2015-0115; FMCSA-2015-0117. Their exemptions are applicable as of
September 12, 2019, and will expire on September 12, 2021.

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 ten 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.

    Issued on: September 25, 2019.
Larry W. Minor,
Associate Administrator for Policy.
[FR Doc. 2019-21280 Filed 9-30-19; 8:45 am]
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[Federal Register Volume 79, Number 199 (Wednesday, October 15, 2014)]
[Notices]
[Pages 61876-61877]
[FR Doc No: 2014-24451]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-1496]

Regulatory Science Considerations for Software Used in Diabetes
Management; Public Workshop; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop; request for comments.

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    The Food and Drug Administration (FDA) is announcing the following
public workshop entitled ``Regulatory Science Considerations for
Software Used in Diabetes Management.'' The goals of this public
workshop are to foster greater stakeholder collaboration in the area of
diabetes device interoperability and to seek input from the clinical
community, academia, government, industry, and other stakeholders
regarding usability considerations for appropriate information
consumption (e.g., notifications, indicators, data, and displays) based
on user skill and knowledge. The Agency also requests input regarding
the technical considerations for insulin bolus calculator design and
use.
    Date and Time: The public workshop will be held on November 13,
2014, from 8 a.m. to 5 p.m.
    Location: The public workshop will be held at the FDA White Oak
Campus, 10903 New Hampshire Ave., Building 31 Conference Center, the
Great Room (Rm. 1503), Silver Spring, MD 20993. Entrance for public
workshop participants (non-FDA employees) is through Building 1 where
routine security check procedures will be performed. For parking and
security information, please refer to http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm. Please arrive early to ensure time for parking and
security screening. The public meeting will also be available to be
viewed online via Webcast.
    Contact Persons: James Mullally, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5613, Silver Spring, MD 20993,<PHONE_NUMBER>, FAX:
301-847-8513, email<EMAIL_ADDRESS>and Runa Musib, Center
for Devices and Radiological Health, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 66, Rm. 5633, Silver Spring, MD 20993,
301-796-7014, FAX:<PHONE_NUMBER>, email<EMAIL_ADDRESS>    Registration: Registration is free and available on a first-come,
first-served basis. You must register online by 4 p.m., November 6,
2014. Early registration is recommended because facilities are limited
and, therefore, FDA may limit the number of participants from each
organization. If time and space permit, onsite registration on the day
of the public workshop will be provided beginning at 7 a.m. If you need
special accommodations due to a disability, please contact Susan
Monahan,<PHONE_NUMBER>, email<EMAIL_ADDRESS>no later than
October 30, 2014.
    To register for the public workshop, please visit FDA's Medical
Devices News & Events--Workshops & Conferences calendar at http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm
(select this public workshop from the posted events list). Please
provide complete contact information for each attendee, including name,
title, affiliation, address, email, and telephone number. Those without
Internet access should contact Susan Monahan to register (see
registration contact person). Registrants will receive confirmation
after they have been accepted. You will be notified if you are on a
waiting list.
    Streaming Webcast of the Public Workshop: This public workshop will
also be Webcast. Persons interested in viewing the Webcast must
register online by 4 p.m., November 6, 2014. Early registration is
recommended because Webcast connections are limited. Organizations are
requested to register all participants, but to view using one
connection per location. Webcast participants will be sent technical
system requirements after registration and will be sent connection
access information after November 6, 2014. If you have never attended a
Connect Pro event before, test your connection at https://collaboration.fda.gov/common/help/en/support/meeting_test.htm. To get a
quick overview of the Connect Pro program, visit http://www.adobe.com/go/connectpro_overview. (FDA has verified the Web site addresses in
this document, but FDA is not responsible for any subsequent changes to
the Web

sites after this document publishes in the Federal Register.)
    Requests for Oral Presentations: This public workshop includes a
public comment session. During online registration you may indicate if
you wish to speak during the public comment session and which topics
you wish to address. FDA has included general topics in this document.
FDA will do its best to accommodate requests to make public comments.
Following the close of registration, FDA will determine the amount of
time allotted to each speaker and will select and notify participants
by November 10, 2014. No commercial or promotional material will be
permitted to be presented or distributed at the public workshop.
    Comments: FDA is holding this public workshop to obtain input on
insulin bolus calculators. In order to permit the widest possible
opportunity to obtain public comment, FDA is soliciting either
electronic or written comments regarding the public workshop topics
that pertain to insulin bolus calculators. The deadline for submitting
comments related to this public workshop is December 11, 2014.
    Regardless of attendance at the public workshop, interested persons
may submit either electronic comments regarding this document to http://www.regulations.gov or written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852. It is only necessary to send one set of
comments. Please identify comments with the docket number found in
brackets in the heading of this document. In addition, when responding
to specific questions as outlined in section II of this document,
please identify the question number you are addressing. Received
comments may be seen in the Division of Dockets Management between 9
a.m. and 4 p.m., Monday through Friday, and will be posted to the
docket at http://www.regulations.gov.
    Transcripts: Please be advised that as soon as a transcript is
available, it will be accessible at http://www.regulations.gov. It may
be viewed at the Division of Dockets Management (see Comments). A
transcript will also be available in either hardcopy or on CD-ROM,
after submission of a Freedom of Information request. Written requests
are to be sent to the Division of Freedom of Information (ELEM-1029),
Food and Drug Administration, 12420 Parklawn Dr., Element Bldg.,
Rockville, MD 20857. A link to the transcripts will also be available
on the Internet at http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm (select this public workshop from the
posted events list), approximately 45 days after the workshop.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is seeking to foster greater stakeholder collaboration in the
area of diabetes device interoperability. To that end, the Agency
requests input from the clinical community, academia, government,
industry, and other stakeholders regarding usability considerations for
appropriate information consumption (e.g., notifications, indicators,
data, and displays) based on user skill and knowledge. The Agency also
requests input regarding the technical considerations for calculator
design and use.
    The first topic of discussion is the interoperability between
diabetes devices. The Agency recognizes that the diabetes community
possesses an interest in patients having greater flexibility to pair
device components, e.g., continuous glucose meters with insulin pumps
from different manufacturers. Pairing would allow those devices to
communicate with each other and enable patients to interact with a
single interface platform. Achieving this goal would improve data
tracking and access, thereby facilitating more productive patient
interactions with their healthcare providers. In order to realize the
objective of effective diabetes device interoperability, developers and
manufacturers should discuss technical, safety, and regulatory
challenges that lay before this goal. A forum that elicits opinions
from physicians and patients regarding their desires and needs will
help inform those discussions. FDA is committed to fostering a
collaborative environment to promote these interactions.
    The second topic of discussion is insulin bolus calculators. These
devices are intended to calculate insulin boluses for patients who
manage their diabetes with insulin-intensive therapy. FDA currently
regulates insulin bolus calculators as class II devices, often clearing
them in combination with insulin pumps or blood glucose meters. Devices
that calculate insulin boluses are increasingly available on the
market, including those devices that use novel dosing algorithms and
new user interface formats. Although these devices can benefit patient
care, they could also jeopardize patient safety without proper
regulation guarding against the serious health consequences of
miscalculating insulin dosages. The Agency will host a public dialogue
about insulin bolus calculators to help realize the aim of ensuring
continued access to safe and effective technological innovations,
regardless of interface format.
    The public workshop will include two sessions, one for each of the
topics noted previously. Each session will include presentations from
physicians, FDA, and other experts in the field. A panel discussion
will follow the session addressing insulin bolus calculators, and the
panel will address questions from the audience. In addition, Agency
representatives will update the diabetes community on relevant FDA
news.

II. Topics for Discussion at the Public Workshop

    Among other topics, the workshop will include discussion of the
following questions.
    1. How can patients and providers be confident that the insulin
bolus values obtained from the calculators are accurate and appropriate
for their use?
    2. What information do patients and providers need about how a
particular calculator works so that they may appropriately use the
calculator for diabetes management?
    3. How can FDA foster both innovation and safety of insulin dose
calculators intended for use by healthcare practitioners?
    4. How can FDA foster both innovation and safety of insulin dose
calculators intended for use by patients?

    Dated: October 8, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-24451 Filed 10-14-14; 8:45 am]
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