[Federal Register Volume 76, Number 166 (Friday, August 26, 2011)]
[Proposed Rules]
[Pages 53364-53369]
[FR Doc No: 2011-21866]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Subchapter S

[Docket No. USCG-2011-0497]
RIN 1625-AB73

Recreational Vessel Propeller Strike and Carbon Monoxide
Poisoning Casualty Prevention

AGENCY: Coast Guard, DHS.

ACTION: Advance notice of proposed rulemaking.

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SUMMARY: The Coast Guard seeks public input on how best to prevent
recreational boating casualties caused by propeller strikes and carbon
monoxide (CO) poisoning. The Coast Guard, in particular, seeks comments
on specific measures to protect recreational

boaters in the water near the stern of a recreational vessel. The Coast
Guard also seeks additional ideas, specific data, and other facts
relating to propeller strike and CO poisoning-related casualties to
help guide the Coast Guard in selecting the best course of action to
address these issues.

DATES: Comments and related material must either be submitted to our
online docket via http://www.regulations.gov on or before November 25,
2011 or reach the Docket Management Facility by that date.

ADDRESSES: You may submit comments identified by docket number USCG-
2011-0497 using any one of the following methods:
    (1) Federal eRulemaking Portal: http://www.regulations.gov.
    (2) Fax:<PHONE_NUMBER>.
    (3) Mail: Docket Management Facility (M-30), U.S. Department of
Transportation, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue, SE., Washington, DC 20590-0001.
    (4) Hand delivery: Same as mail address above, between 9 a.m. and 5
p.m., Monday through Friday, except Federal holidays. The telephone
number is<PHONE_NUMBER>.
    To avoid duplication, please use only one of these four methods.
See the ``Public Participation and Request for Comments'' portion of
the SUPPLEMENTARY INFORMATION section below for instructions on
submitting comments.

FOR FURTHER INFORMATION CONTACT: If you have questions on this advanced
notice of proposed rulemaking, call or e-mail Jeff Ludwig, Coast Guard;
telephone<PHONE_NUMBER>, e-mail<EMAIL_ADDRESS>If you have
questions on viewing or submitting material to the docket, call Renee
V. Wright, Program Manager, Docket Operations, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Table of Contents for Preamble

I. Public Participation and Request for Comments
    A. Submitting Comments
    B. Viewing Comments and Documents
    C. Privacy Act
    D. Public Meeting
II. Abbreviations
III. Background
    A. Propeller Strike-Related Casualties
    B. CO Poisoning-Related Casualties
IV. Information Requested
    A. General Questions Regarding Measures To Address Propeller
Strike-Related and CO Poisoning-Related Casualties
    B. Specific Measures To Address Propeller Strike-Related and CO
Poisoning-Related Casualties
    C. Specific Information Sought

I. Public Participation and Request for Comments

    We encourage you to respond to this advance notice of proposed
rulemaking by submitting comments and related materials. All comments
received will be posted, without change, to http://www.regulations.gov
and will include any personal information you have provided.

A. Submitting Comments

    If you submit a comment, please include the docket number for this
rulemaking (USCG-2011-0497), 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. We recommend that you include your name and a mailing
address, an e-mail address, or a telephone number in the body of your
document so that we can contact you if we have questions regarding your
submission.
    To submit your comment online, go to http://www.regulations.gov and
type ``USCG-2011-0497'' in the ``Keyword'' box. 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 material received during
the comment period.

B. Viewing Comments and Documents

    To view comments, as well as documents mentioned in this preamble
as being available in the docket, go to http://www.regulations.gov and
click on the ``Read Comments'' box, which will then become highlighted
in blue. In the ``Keyword'' box type ``USCG-2011-0497'' and click
``Search.'' Click the ``Open Docket Folder'' in the ``Actions'' column.
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 Department of Transportation West Building,
1200 New Jersey Avenue, SE., Washington, DC 20590, between 9 a.m. and 5
p.m., Monday through Friday, except Federal holidays. We have an
agreement with the Department of Transportation to use the Docket
Management Facility.

C. Privacy Act

    Anyone can search the electronic form of comments received into any
of our dockets by the name of the individual submitting the comment (or
signing the comment, if submitted on behalf of an association,
business, labor union, etc.). You may review a Privacy Act notice
regarding our public dockets in the January 17, 2008, issue of the
Federal Register (73 FR 3316).

D. Public Meeting

    We do not now plan to hold a public meeting. However, you may
submit a public meeting request to the docket using one of the methods
specified under ADDRESSES. In your request, explain why you believe a
public meeting would be beneficial. If we determine that holding a
public meeting would aid us in determining how best to prevent
recreational boating casualties caused by propeller strikes and carbon
monoxide (CO) poisoning, we will hold a meeting at a time and place
announced by a later notice in the Federal Register.

II. Abbreviations

ABYC American Boat and Yacht Council
CO Carbon monoxide
DHS Department of Homeland Security
ECOS Engine cut-off switches
EPA Environmental Protection Agency
FR Federal Register
NBSAC National Boating Safety Advisory Committee
NASBLA National Association of State Boating Law Administrators
NIOSH National Institute for Occupational Safety and Health
Sec.  Section symbol
U.S.C. United States Code

III. Background

    In a recent five year period, approximately 82.1 million people
annually participated in recreational boating as an outdoor recreation
activity in the United States.\1\ Of that population, approximately
53.8 million people enjoyed recreational boating on a motorized
recreational vessel. Unfortunately, motorized recreational boating
poses risks, including property damage, human injury, and even death.
One of these risks is boating casualties caused by persons being struck
by a recreational vessel propeller. An additional, more recently
discovered

risk is boating casualties caused by carbon monoxide (CO) poisoning.
The Coast Guard is interested in measures to reduce these two specific
risks, both of which involve persons near the rear of a motorized
recreational vessel.
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    \1\ H. Ken Cordell et al., Long-Term National Trends in Outdoor
Recreation Activity Participation--1980 to Now, May 2009 (A
Recreation Research Report in the Internet Research Information
Series), available at http://warnell.forestry.uga.edu/nrrt/nsre/IRISRec/IRISRec12rpt.pdf. This number represents the estimated
number of people, operators and passengers who participated in
recreational boating in 2005-2009.
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    Under 46 U.S.C. chapter 43 (Recreational Vessels), the Secretary of
the Department of Homeland Security is responsible for establishing
minimum safety standards for recreational vessels and associated
equipment, and for requiring installation, carrying, or use of
associated equipment. See 46 U.S.C. 4302(a). The Coast Guard, on behalf
of the Secretary, carries out this responsibility.

Propeller Strike-Related Casualties

    Since the mid-1990s, the Coast Guard has investigated the
appropriate course of action to address propeller strike-related
casualties, to understand the causes of these casualties, and to
determine the best way to prevent casualties from occurring. The Coast
Guard has solicited requests for comments on various proposals to
reduce propeller strike-related casualties, and proposed and then
withdrew two separate rulemakings addressing this issue. The first
rulemaking sought public input on the use of swimming ladders, warning
notices, clear aft vision, propeller-shaft engagement alarms, engine
cut-off switches, and education to address recreational vessel and
propeller strike-related casualties. See 60 FR 25191 (May 11, 1995)
(Request for comments); 61 FR 13123 (Mar. 26, 1996) (Advance Notice of
Proposed Rulemaking); 62 FR 22991 (Apr. 28, 1997) (Request for
comments). The Coast Guard withdrew this rulemaking because of a lack
of sufficient data for the proposals at that time. See 66 FR 63650
(Dec. 10, 2001) (Notice of Withdrawal).
    At the same time the Coast Guard withdrew the first rulemaking, it
initiated the second rulemaking, which focused on propeller injury
mitigation devices commonly referred to as ``propeller guards.'' The
notice of proposed rulemaking proposed requiring owners of certain
recreational houseboats to either install a propeller guard or to use
all of the following propeller injury avoidance measures: a swim ladder
interlock, an aft visibility device, and an engine cut-off switch. See
66 FR 63645 (Dec. 10, 2001). The Coast Guard withdrew this rulemaking
after public comments raised several issues, including the lack of a
practical definition of a houseboat and straightforward performance
requirements, and the potential costs of installing propeller guards.
See 72 FR 59064 (Oct. 18, 2007) (Notice of Withdrawal). In the Notice
of Withdrawal, the Coast Guard stated that it is still ``exploring
options that would more effectively prevent propeller injuries and
impose a smaller burden on the economy,'' and specifically noted engine
cut-off switches and boating safety education as two of those options.
Id. at 59065.
    In 2006, the National Boating Safety Advisory Council (NBSAC)
established a Propeller Injury Working Group to consider the
development of educational formats, review of technologies, risk
management techniques, accident scenarios, cost benefit analysis, and
high-risk recreational vessel definitions and determinations. See NBSAC
Resolution  2005-76-04, available at http://homeport.uscg.mil/NBSAC. The working group proposed four recommendations: (1) Develop a
rental vessel education kit, (2) require the installation of engine
cut-off switches, (3) require operators to use installed engine cut-off
switches, and (4) require operators of vessels to shut off the engine
when individuals in the water are within an unsafe distance from the
vessel. NBSAC endorsed these recommendations and forwarded them to the
Coast Guard for further consideration. See NBSAC Resolution
 2006-77-01, 2006-77-02, 2006-77-03 and 2006-77-04,
available at http://homeport.uscg.mil/NBSAC.
    To address NSBAC's second and third recommendations (NBSAC
Resolution  2006-77-02 and 2006-77-03) involving the
installation, maintenance, and use of engine cut-off switches \2\ and
to follow-up on the discussion of engine cut-off switches in the Notice
of Withdrawal of the propeller guard rulemaking, the Coast Guard
initiated a separate rulemaking titled ``Installation and Use of Engine
Cut-Off Switches'' (ECOS) (RIN 1625-AB34). In the ECOS rulemaking, the
Coast Guard seeks to prevent recreational boating casualties caused by
persons being struck by a recreational vessel or propeller when the
vessel operator is separated from the operating controls (e.g., falls
overboard or is ejected). The ECOS rulemaking, however, only addresses
one cause of propeller-strikes. Recreational boaters in the water near
the rear of a recreational vessel also face the possibility of being
inadvertently struck by a vessel's propeller even when the vessel
operator is in control of the vessel.
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    \2\ In response to the first recommendation (NBSAC Resolution
 2006-77-01), the Coast Guard developed a rental education
kit, which is now available to vessel liveries through the following
Web site: http://rentalboatsafety.com/participate.php.
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    The Coast Guard is initiating this rulemaking to seek public input
on NSBAC's fourth recommendation in NBSAC Resolution  2006-77-
04, as well as other options to prevent casualties caused when persons
in the water near the rear of a recreational vessel are inadvertently
struck by a vessel's propeller. For example, a person may be struck by
a propeller when using the lower unit of the recreational vessel's
propulsion system as a step to reboard the vessel. If the propeller is
spinning while a person is attempting to use the lower unit as a step,
the person may either step directly onto the spinning propeller or slip
off the lower unit of the propulsion system and fall onto the spinning
propeller resulting in severe injuries and possibly death.

CO Poisoning-Related Casualties

    Over the last decade, boating-related activities that require
participants to be near the rear of a recreational vessel in close
proximity to a vessel's engine exhaust emissions have increased in
popularity. With an increase in the prevalence of these activities,
casualties associated with these activities have also increased, and
investigations of these casualties have led to an increased
understanding of CO concentrations near the rear of recreational
vessels.
    A potentially deadly gas that is odorless, colorless, and
tasteless, CO occurs as a component of internal combustion engine
exhaust. When inhaled, CO enters the bloodstream through the lungs and
displaces the oxygen needed by the body, resulting in hypoxia
(suffocation) of body tissues.
    In 2000, the National Park Service, in coordination with the
National Institute for Occupational Safety and Health (NIOSH) and the
Coast Guard, initiated a study to evaluate CO exposure from generators
and propulsion engines on houseboats.\3\ This study revealed high
concentrations of CO on and around houseboats using gasoline-powered
generators. In 2002, the National Park Service, NIOSH, and the Coast
Guard began working to measure CO levels on other types of recreational
vessels and to evaluate new engineering technologies

designed to reduce CO poisonings related to the vessels' operation.
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    \3\ Department of Health and Human Services, Center for Disease
Control, National Institute for Occupational Safety and Health,
NIOSH Health Hazard Evaluation Report: HETA #2000-0400-2956, HETA #
2002-0325-2956, Glen Canyon National Recreation Area, Arizona and
Utah (January 2005) available at http://www.cdc.gov/niosh/hhe/reports/pdfs/2000-0400-2956.pdf.
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    In 2008, the Environmental Protection Agency (EPA) promulgated
exhaust emission standards for marine engines, including first-time EPA
standards for sterndrive and inboard engines. See 73 FR 59034
(``Control of Emissions from Nonroad Spark-Ignition Engines and
Equipment''). The EPA standards apply to new marine engines, and the
Coast Guard expects these EPA standards to have a dramatic effect on
the levels of CO in the exhaust emissions of new sterndrive and inboard
engines and thus reduce CO levels on recreational vessels with such
engines.
    In response to the EPA standards, as well as to address CO
poisoning-related casualties, manufacturers have developed new
catalyst-based low CO sterndrive and inboard engines. These EPA
standards and resulting new technology, however, apply only to newly
manufactured engines, and do not affect potentially dangerous levels of
CO on recreational vessels with older engines.
    The National Association of State Boating Law Administrators
(NASBLA), as well as some States, are also concerned with the issue of
CO poisoning-related casualties, and efforts to address this issue
cover both new as well as existing recreational engines by focusing on
recreational vessel operation rather than on technology. NASBLA has
been engaged in addressing this issue since 2003 and has developed a
consensus model act prohibiting persons from operating any recreational
vessel or having the engine idle while someone is in the water and
holding onto the rear of the recreational vessel. See NASBLA Model Act
for ``Safe Practices for Boat-Towed Watersports'' (September 10, 2007),
available at http://nasbla.org/i4a/pages/index.cfm?pageid=3290. At
least five States have enacted laws addressing CO poisoning-related
casualties based on this model act.
     California and Washington have prohibited operating a
recreational vessel or having the engine of the vessel idle while an
individual is ``teak surfing, platform dragging, or bodysurfing
behind'' \4\ or ``occupying or holding onto the swim platform, swim
deck, swim step, or swim ladder of the vessel,'' except ``when an
individual is occupying the swim platform, swim deck, swim step, or
swim ladder for a very brief period of time while assisting with the
docking or departure of the vessel, while exiting or entering the
vessel, or while the vessel is engaged in law enforcement or emergency
rescue activity.'' See Cal. Harb. & Nav. Code Sec.  681 (West); Wash.
Rev. Code Ann. Sec.  79A.60.660 (West).
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    \4\ ``Teak surfing'' or ``platform dragging'' means holding onto
the swim platform, swim deck, swim step, swim ladder, or any portion
of the exterior of the transom of a motor driven vessel for any
amount of time while the motor driven vessel is underway at any
speed. See Cal. Harb. & Nav. Code Sec.  681(d) (West); Wash. Rev.
Code Ann. Sec.  79A.60.660(4) (West). ``Bodysurfing'' means swimming
or floating on one's stomach or on one's back on or in the wake
directly behind a motor driven vessel that is underway. See Cal.
Harb. & Nav. Code Sec.  681(e) (West); Wash. Rev. Code Ann. Sec.
79A.60.660(5) (West).
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     Nevada has prohibited operation of a recreational vessel
while any person is hanging onto, or sitting, standing or riding on, a
swim platform or a swim ladder that is attached to the vessel as a form
of reckless or negligent operation of a vessel. See Nev. Rev. Stat.
Sec.  488.400; Nev. Admin. Code Sec.  488.435.
     Oregon prohibits operating a recreational vessel or having
the vessel's engine idle while any person holds onto or occupies any
portion of the vessel located aft of the transom, including a step,
ladder, platform or deck, in order to ride on that portion of the
vessel while the vessel is under way at any speed or to be pulled by
the vessel, except when assisting in the docking or departure of the
vessel, exiting or entering the vessel, or engaging in law enforcement
activities. See Or. Rev. Stat. Sec.  830.362.
     Pennsylvania prohibits operation of a recreational vessel
at any speed with a person or persons sitting, riding, or hanging on a
swim platform or swim ladder attached to the vessel, except when
launching, retrieving, docking or anchoring the vessel. See 58 Pa. Code
Sec.  105.3.
    The Coast Guard is initiating this rulemaking to consider options
to prevent CO poisoning-related casualties on all recreational vessels,
especially existing recreational vessels that are not affected by the
2008 EPA exhaust emission standards or by new technology for marine
engines.

IV. Information Requested

    In addition to any general information, data, ideas, and comments
that the public would like to provide, the Coast Guard requests
comments on specific measures outlined below to prevent propeller
strike-related and CO poisoning-related casualties. The Coast Guard
also seeks specific information regarding certain data and other facts
related to these measures, as listed below. Please provide as much
quantitative data as possible, including data sources and complete
citations.

A. General Questions Regarding Measures To Address Propeller Strike-
Related and CO Poisoning-Related Casualties

    When responding to the general questions below, please provide
quantitative data on costs, benefits, and other relevant information,
specifying sources of information and citations.
    1. Recreational boating accidents can cause a variety of negative
impacts, including loss of life, injuries, and property damage. What
sources of data or information exist detailing benefits or avoided
damages which may result from the use of measures to avoid propeller
strike-related and CO poisoning-related casualties?
    2. What vessel types should be considered for mandatory measures to
reduce or eliminate propeller strike-related and CO poisoning-related
casualties (e.g., all motorized vessels, motorized vessels with certain
engine configurations, certain types of motorized vessels (e.g.,
houseboats)?
    3. Some vessels have measures already installed to reduce or
eliminate propeller strike-related and CO poisoning-related casualties.
What data exists to estimate the percentage of recreational vessels
that have measures to reduce or eliminate propeller strike-related and
CO poisoning-related casualties?
    4. How many and what types of recreational vessels or engines do
not have measures to reduce or eliminate propeller strike-related and
CO poisoning-related casualties?
    5. What is the average amount of time it would take for a vessel
operator to use each measure to reduce or eliminate propeller strike-
related and CO poisoning-related casualties?
    6. How would operators and passengers be impacted by the number of
times each measure to reduce or eliminate propeller strike-related and
CO poisoning-related casualties is used by the vessel operator? How
should the Coast Guard consider the potential ``hassle factor''
associated with using each measure to reduce or eliminate propeller
strike-related and CO poisoning-related casualties?
    7. If a vessel or engine currently does not have any measures to
reduce or eliminate propeller strike-related and CO poisoning-related
casualties installed, what are the installation costs, separated out
into parts and labor categories, for each such measure?
    8. What is the average lifespan of each measure used to reduce or
eliminate propeller strike-related and CO poisoning-related casualties?
    9. What are the associated maintenance and replacement costs of

each measure used to reduce or eliminate propeller strike-related and
CO poisoning-related casualties?
    10. What is the recommended replacement schedule of each measure
used to reduce or eliminate propeller strike-related and CO poisoning-
related casualties? How often are pieces of equipment replaced? What is
the average cost of replacement per piece of equipment? What is the
average cost of purchasing any required spare equipment?
    11. How would individual measures change boater preference for
different measures used to reduce or eliminate propeller strike-related
and CO poisoning-related casualties? Would boaters choose more
expensive systems over standard systems? If so, why?
    12. What is the risk of unintended activations of each measure used
to reduce or eliminate propeller strike-related and CO poisoning-
related casualties? What is the current estimated rate of unintended
activations? What are the impacts of unintended activations? Are there
any injuries or fatalities associated with unintended activations?
    13. What is the risk of each measure used to reduce or eliminate
propeller strike-related and CO poisoning-related casualties (i.e.,
engine does not cut off when interlock device is engaged)? What is the
current estimated rate of device failures? What are the impacts of
device failures? Are there any injuries or fatalities associated with
such device failures?
    14. What data or information exists that could be used to estimate
compliance rates for measures used to reduce or eliminate propeller
strike-related and CO poisoning-related casualties? What data exists to
estimate how compliance will change from initial phase-in to full
implementation of possible mandatory measures?
    15. How would the Coast Guard or other law enforcement officers
enforce required measures used to reduce or eliminate propeller strike-
related and CO poisoning-related casualties? What would be the
challenges with such enforcement? What would be the training costs and
other impacts on law enforcement agencies of implementing measures used
to reduce or eliminate propeller strike-related and CO poisoning-
related casualties?
    16. Would any of the different measures designed to reduce or
eliminate propeller strike-related and CO poisoning-related casualties
have a significant economic impact on a substantial number of small
entities? What sources of data or information exist detailing the
economic impact on small entities which may result from the use of
measures to avoid propeller strike-related and CO poisoning-related
casualties?
    17. What are the compliance rates with State laws intended prevent
propeller strike-related casualties for recreational boaters?
    18. What are the compliance rates with State laws intended to
prevent CO poisoning-related casualties for recreational boaters?
    19. What is the voluntary use rate of measures designed to reduce
or eliminate propeller strike-related and CO poisoning-related
casualties in States without such laws?
    20. Five States (California, Washington, Nevada, Oregon and
Pennsylvania) currently require measures to reduce or prevent propeller
strike-related and CO poisoning-related casualties. What other State
laws or regulations are being developed with measures to reduce or
prevent propeller strike-related and CO poisoning-related casualties?
Please provide any data or information from the implementation or
development of these State regulations to assist the Coast Guard as it
considers whether to require measures to reduce or eliminate propeller
strike-related and CO poisoning-related casualties.
    21. What are the costs associated with implementation of the
aforementioned State laws?

B. Specific Measures To Address Propeller Strike-Related and CO
Poisoning-Related Casualties

    1. A possible requirement that operators of recreational vessels
turn off the recreational vessel's engine while persons are in the
water in close proximity to the rear of the vessel. If an operator
turned off a vessel's engine, persons in the water behind the vessel
would not come into contact with a spinning propeller or inhale CO
emitted from a running engine. ``Close proximity'' would be defined as
when a person is either touching any part of the vessel or is close
enough to touch any part of the vessel.
    2. A possible requirement to use longer boarding ladders on new
recreational vessels. A longer boarding ladder than what is currently
used on most recreational vessels would make it less likely that the
person boarding the vessel would use the lower unit in order to reach
the ladder. As discussed above, if the propeller is spinning while a
person is attempting to use the lower unit as a step, the person may
either step directly onto the spinning propeller or slip off the lower
unit of the propulsion system and fall onto the spinning propeller
resulting in severe injuries and possibly death.
    3. A possible requirement to use boarding ladder or swim platform
entrance gate ``interlocks'' on new recreational vessels. Ladder or
swim platform entrance gate ``interlocks'' would prevent a recreational
vessel engine from starting if the boarding ladder was deployed or the
swim platform entrance gate was not closed, thus preventing a person
using a boarding ladder or swim platform from coming into contact with
a spinning propeller.

C. Specific Information Sought

    When responding to the questions below, please explain the
reasoning behind your comment and provide data sources and citations.
    1. We seek comments on measure number 1 described above that would
require operators of recreational vessels to turn off the recreational
vessel's engine while persons are in the water in close proximity to
the rear of the vessel. We also seek comments regarding the potential
meaning of ``close proximity'' for this proposal and whether there
should be exemptions to any such proposed requirement to turn the
vessel off. Should such a proposal closely mirror the State laws
discussed above?
    2. Are there scenarios, other than a person in the water in close
proximity to the rear of the vessel, in which turning off the vessel's
engine would similarly protect recreational boaters?
    3. Would there be any adverse impacts to recreational vessels,
recreational boaters, or the recreational boating experience by turning
off the vessel's engine when a person is in the water in close
proximity to the rear of the vessel or in other similar scenarios?
    4. How should the Coast Guard consider the potential ``hassle
factor'' associated with turning off the vessel's engine when a person
is in the water in close proximity to the vessel?
    5. What is the average number of times per trip a recreational
vessel's engine would have to be turned off because of a person in
close proximity to the vessel?
    6. How effective would measure number 1 be in preventing accidents
related to both propeller strikes and CO poisoning?
    7. How would the challenge to visually inspect at a distance
whether a person is in close proximity to a vessel affect compliance
with any turn-the-vessel-off requirements?
    8. What data or information exists that could be used to estimate
compliance rates of measure number 1? What data

exists to estimate how such compliance will change during full
implementation?
    9. We seek comments on measure number 2 described above to require
use of longer reboarding ladders. We understand that the American Boat
and Yacht Council (ABYC) has a proposed revision to ABYC Standard H-
41--Reboarding Means, Ladders, Handholds, Rails, and Lifelines, that
would address longer ladders. Are there other consensus industry
standards addressing longer ladders?
    10. What percentage of new recreational vessels are sold with a
swim ladder installed? What percentage of existing recreational vessels
currently have a swim ladder installed? What is the typical length of a
swim ladder that recreational vessel manufacturers currently install?
    11. What are the costs for installation of a reboarding ladder?
    12. What data or information exists that could be used to estimate
compliance rates of measure number 2? What data exists to estimate how
such compliance will change during full implementation?
    13. We seek comments on measure number 3 described above to require
use of boarding ladder or swim platform entrance gate ``interlocks'' on
new recreational vessels. Are there any consensus industry standards
addressing interlocks or any such standards in development?
    14. What are the costs for installation of a boarding ladder or
swim platform entrance gate interlock system? What are the costs
associated with maintenance of these systems?
    15. What data or information exists that could be used to estimate
compliance rates of measure number 3? What data exists to estimate how
such compliance will change during full implementation?
    16. What is the risk of device failures or unintended activations
of the boarding ladder or swim platform entrance gate interlocks? What
is the current estimated rate of unintended activations? What are the
impacts of unintended activations? Are there any injuries or fatalities
associated with unintended activations?
    17. What other measures or strategies would prevent propeller
strike-related or CO poisoning-related casualties?
    18. Since the enactment of the aforementioned State laws (CA, NV,
OR, PA, WA), has there been a change in the count and rate of CO
poisoning-related casualties in these States? Is there any quantitative
data, measures, metrics, studies, or other related evidence on the
effectiveness of these State laws?
    19. Should any of the above-listed measures, or other measures or
strategies to prevent propeller strike-related and CO poisoning-related
casualties, be limited to specific recreational vessel types or
lengths, or to some other criteria?
    20. Would any of the above-listed specific measures have a
significant economic impact on a substantial number of small entities?
What sources of data or information exist detailing the economic impact
on small entities which may result from the use of these specific
measures to avoid propeller strike-related and CO poisoning-related
casualties?

    Dated: August 8, 2011.
James A. Watson,
Rear Admiral, U.S. Coast Guard, Director of Prevention Policy.
[FR Doc. 2011-21866 Filed 8-25-11; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 76, Number 53 (Friday, March 18, 2011)]
[Notices]
[Pages 14965-14966]
[FR Doc No: 2011-6432]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings 1

    Take notice that the Commission received the following electric
rate filings:

    Docket Numbers: ER11-2424-000; ER11-2424-001.
    Applicants: Pinetree Power-Tamworth, Inc.
    Description: Second Supplemental Request for Acceptance of Market-
Based Rate Tariff, Waivers and Blanket Authority of PINETREE POWER-
TAMWORTH, INC. under ER11-2424, et al.
    Filed Date: 03/09/2011.
    Accession Number: 20110309-5136.
    Comment Date: 5 p.m. Eastern Time on Wednesday, March 30, 2011.

    Docket Numbers: ER11-2695-001.
    Applicants: Wisconsin Power and Light Company.
    Description: Wisconsin Power and Light Company submits tariff
filing per 35.17(b): WPL Changes in Depreciation Rates for Wholesale
Production Service Amendment to be effective 3/31/2011.
    Filed Date: 03/09/2011.
    Accession Number: 20110309-5041.
    Comment Date: 5 p.m. Eastern Time on Wednesday, March 30, 2011.

    Docket Numbers: ER11-2735-002.
    Applicants: Censtar Energy Corp.
    Description: Censtar Energy Corp. submits tariff filing per 35:
Compliance Filing Under Docket ER11-2735 to be effective 3/28/2011.
    Filed Date: 03/09/2011.
    Accession Number: 20110309-5069.
    Comment Date: 5 p.m. Eastern Time on Wednesday, March 30, 2011.

    Docket Numbers: ER11-2798-000.
    Applicants: Unidentified Registered Entity.
    Description: Supplemental Filing of Midwest Independent
Transmission System Operator, Inc.
    Filed Date: 03/09/2011.
    Accession Number: 20110309-5095.
    Comment Date: 5 p.m. Eastern Time on Wednesday, March 30, 2011.

    Docket Numbers: ER11-3050-000.
    Applicants: FirstEnergy Corp.
    Description: FirstEnergy Corp request for waiver of certain
affiliate restriction requirements.
    Filed Date: 03/09/2011.
    Accession Number: 20110309-0200.
    Comment Date: 5 p.m. Eastern Time on Wednesday, March 30, 2011.

    Docket Numbers: ER11-3051-000.
    Applicants: Macho Springs Power I, LLC.
    Description: Macho Springs Power I, LLC submits tariff filing per
35.12: Market-Based Rate Application to be effective 5/1/2011.
    Filed Date: 03/09/2011.
    Accession Number: 20110309-5083.
    Comment Date: 5 p.m. Eastern Time on Wednesday, March 30, 2011.

    Docket Numbers: ER11-3052-000.
    Applicants: Troy Energy, LLC.
    Description: Troy Energy, LLC's Transfer of Reactive Power Revenue
Requirement.
    Filed Date: 03/09/2011.
    Accession Number: 20110309-5091.
    Comment Date: 5 p.m. Eastern Time on Wednesday, March 30, 2011.

    Docket Numbers: ER11-3053-000.
    Applicants: Holcim (US) Inc.
    Description: Holcim (US) Inc. submits tariff filing per 35.12:
Holcim (US) Inc. MBRA Application to be effective 5/9/2011.
    Filed Date: 03/09/2011.
    Accession Number: 20110309-5114.
    Comment Date: 5 p.m. Eastern Time on Wednesday, March 30, 2011.

    Docket Numbers: ER11-3054-000.
    Applicants: American Electric Power Service Corporation, PJM
Interconnection, L.L.C.
    Description: American Electric Power Service Corporation submits
tariff filing per 35: AEP compliance filing revising Attachment H-14
per Order in Docket No. ER08-1329 to be effective 9/17/2010.
    Filed Date: 03/09/2011.
    Accession Number: 20110309-5115.
    Comment Date: 5 p.m. Eastern Time on Wednesday, March 30, 2011.

    Take notice that the Commission received the following open access
transmission tariff filings:

    Docket Numbers: OA11-6-000.
    Applicants: Cedar Point Wind, LLC.
    Description: Request for Waiver of Cedar Point Wind, LLC.
    Filed Date: 03/09/2011.
    Accession Number: 20110309-5137.
    Comment Date: 5 p.m. Eastern Time on Wednesday, March 30, 2011.

    Any person desiring to intervene or to protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Rules of Practice and Procedure (18 CFR 385.211 and
385.214) on or before 5 p.m. Eastern time on the specified comment
date. It is not necessary to separately intervene again in a subdocket
related to a compliance filing if you have previously intervened in the
same docket. Protests will be considered by the Commission in
determining the appropriate action to be taken, but will not serve to
make protestants parties to the proceeding. Anyone filing a motion to
intervene or protest must serve a copy of that document on the
Applicant. In reference to filings initiating a new proceeding,
interventions or protests submitted on or before the comment deadline
need not be served on persons other than the Applicant.
    As it relates to any qualifying facility filings, the notices of
self-certification [or self-recertification] listed above, do not
institute a proceeding regarding qualifying facility status. A notice
of self-certification [or self-recertification] simply provides
notification that the entity making the filing has determined the
facility named in the notice meets the applicable criteria to be a
qualifying facility. Intervention and/or protest do not lie in dockets
that are qualifying facility self-certifications or self-
recertifications. Any person seeking to

challenge such qualifying facility status may do so by filing a motion
pursuant to 18 CFR 292.207(d)(iii). Intervention and protests may be
filed in response to notices of qualifying facility dockets other than
self-certifications and self-recertifications.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic service, persons with Internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
14 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First St. NE., Washington, DC 20426.
    The filings in the above proceedings are accessible in the
Commission's eLibrary system by clicking on the appropriate link in the
above list. They are also available for review in the Commission's
Public Reference Room in Washington, DC. There is an eSubscription link
on the Web site that enables subscribers to receive e-mail notification
when a document is added to a subscribed dockets(s). For assistance
with any FERC Online service, please e-mail<EMAIL_ADDRESS>
or call<PHONE_NUMBER> (toll free). For TTY, call<PHONE_NUMBER>.

    Dated: March 10, 2011.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2011-6432 Filed 3-17-11; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 80, Number 132 (Friday, July 10, 2015)]
[Notices]
[Page 39771]
[FR Doc No: 2015-16938]

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ENVIRONMENTAL PROTECTION AGENCY

[ER-FRL-9021-8]

Environmental Impact Statements; Notice of Availability

    Responsible Agency: Office of Federal Activities, General
Information<PHONE_NUMBER> or http://www2.epa.gov/nepa.

Weekly receipt of Environmental Impact Statements (EISs)
Filed 06/29/2015 Through 07/03/2015
Pursuant to 40 CFR 1506.9.

Notice

    Section 309(a) of the Clean Air Act requires that EPA make public
its comments on EISs issued by other Federal agencies. EPA's comment
letters on EISs are available at: https://cdxnodengn.epa.gov/cdx-enepa-public/action/eis/search.
EIS No. 20150182, Final, VA, CA, San Francisco Veterans Affairs Medical
Center Long Range Development Plan, Review Period Ends: 08/09/2015,
Contact: Robin Flanagan<PHONE_NUMBER>.
EIS No. 20150183, Final, HUD, CA, Sunnydale-Velasco HOPE SF Master Plan
Project, Review Period Ends: 08/10/2015, Contact: Eugene Flannery 415-
701-5598.
EIS No. 20150184, Draft, USFS, MT, Telegraph Vegetation Project,
Comment Period Ends: 08/24/2015, Contact: Allen Byrd<PHONE_NUMBER>.
EIS No. 20150185, Draft Supplement, USACE, NC, Figure Eight Island
Shoreline Management Project Comment Period Ends: 08/24/2015, Contact:
Mickey Sugg<PHONE_NUMBER>.
EIS No. 20150186, Draft, USACE, CA, Redwood City Harbor Navigation
Improvement, Comment Period Ends: 08/24/2015, Contact: Eric Jolliffe
415-503-6869.
EIS No. 20150187, Final, USFS, CA, Master Special Use Permit and Permit
to Construct Power Line Replacement Projects, Review Period Ends: 08/
24/2015, Contact: Jeff Heys<PHONE_NUMBER>.
EIS No. 20150188, Final, USACE, SC, Charleston Harbor Post 45, Review
Period Ends: 08/10/2015, Contact: Bret Walters<PHONE_NUMBER>.

Amended Notices

EIS No. 20150061, Draft, CALTRANS, CA, SR 710 North Improvements,
Comment Period Ends: 08/05/2015, Contact: Garrett Damrath<PHONE_NUMBER>
Revision to FR Notice Published 03/13/2015; Extending Comment Period
from 07/06/2015 to 08/05/2015.
EIS No. 20150109, Draft, STB, MT, Tongue River Railroad, Comment Period
Ends: 08/24/2015, Contact: Ken Blodgett 1-866-622-4355 Revision to FR
Notice Published 04/24/2015; Extending Comment Period from 06/23/2015
to 08/24/2015.
EIS No. 20150151, Draft, USFS, CO, Spruce Beetle Epidemic and Aspen
Decline Management Response, Comment Period Ends: 07/31/2015, Contact:
Scott Williams<PHONE_NUMBER> Revision to FR Notice Published 05/29/2015;
Extending Comment Period from 07/14/2015 to 07/31/2015.

    Dated: July 7, 2015.
Karin Leff,
Acting Director, NEPA Compliance Division, Office of Federal
Activities.
[FR Doc. 2015-16938 Filed 7-9-15; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 85, Number 14 (Wednesday, January 22, 2020)]
[Notices]
[Page 3670]
[FR Doc No: 2020-00923]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 11834-072]

Brookfield White Pine Hydro, LLC; Notice of Application for
Amendment of License, Soliciting Comments, Motions To Intervene, and
Protests

    Take notice that the following hydroelectric application has been
filed with the Commission and is available for public inspection:
    a. Type of Proceeding: Application for temporary variance of
reservoir elevation.
    b. Project No.: 11834-072.
    c. Date Filed: January 6, 2020.
    d. Licensee: Brookfield White Pine Hydro, LLC.
    e. Name of Project: Upper and Middle Dams Storage Project.
    f. Location: The project is located on the Rapid River in Oxford
and Franklin counties, Maine.
    g. Filed Pursuant to: Federal Power Act, 16 U.S.C. 791a-825r.
    h. Licensee Contact: Mr. Kyle Murphy, Brookfield Renewable, 150
Main Street, Lewiston, ME,<PHONE_NUMBER>,
<EMAIL_ADDRESS>    i. FERC Contact: Ms. Rebecca Martin,<PHONE_NUMBER>,
<EMAIL_ADDRESS>    j. Deadline for filing comments, interventions, and protests is
February 13, 2020. The Commission strongly encourages electronic
filing. Please file motions to intervene, protests and comments using
the Commission's eFiling system at http://www.ferc.gov/docs-filing/efiling.asp. Commenters can submit brief comments up to 6,000
characters, without prior registration, using the eComment system at
http://www.ferc.gov/docs-filing/ecomment.asp. You must include your
name and contact information at the end of your comments. For
assistance, please contact FERC Online Support at
<EMAIL_ADDRESS>(866) 208-3676 (toll free), or (202) 502-
8659 (TTY). In lieu of electronic filing, please send a paper copy to:
Secretary, Federal Energy Regulatory Commission, 888 First Street NE,
Washington, DC 20426. The first page of any filing should include
docket number P-11834-072.
    k. Description of Request: The applicant requests a temporary
variance from article 402 of its license to operate the reservoir
elevation below its normal winter minimum elevation of 1437 feet mean
sea level (msl), to allow for structural repairs to the Middle Dam. The
licensee would maintain a minimum elevation of 1436.0 feet msl from
March 1 through April 15 beginning in 2020 and during the same time
period through 2024. The drawdown would allow for the repairs to be
completed in the dry and during the reduced recreation season. The
licensee would hold back additional water at the Upper Dam Development,
located upstream of the Middle Dam, during the construction years to
assist in the refill of the Middle Dam Reservoir, Richardson Lake.
    l. This filing may be viewed on the Commission's website at http://www.ferc.gov/docs-filing/elibrary.asp. Enter the docket number
excluding the last three digits in the docket number field to access
the document. You may also register online at http://www.ferc.gov/docs-filing/esubscription.asp to be notified via email of new filings and
issuances related to this or other pending projects. For assistance,
call 1-866-208-3676 or email<EMAIL_ADDRESS>for TTY, call
(202) 502-8659. A copy is also available for inspection and
reproduction in the Commission's Public Reference Room located at 888
First Street NE, Room 2A, Washington, DC 20426, or by calling (202)
502-8371.
    m. Individuals desiring to be included on the Commission's mailing
list should so indicate by writing to the Secretary of the Commission.
    n. Comments, Protests, or Motions to Intervene: Anyone may submit
comments, a protest, or a motion to intervene in accordance with the
requirements of Rules of Practice and Procedure, 18 CFR 385.210, .211,
.212 and .214. In determining the appropriate action to take, the
Commission will consider all protests or other comments filed, but only
those who file a motion to intervene in accordance with the
Commission's Rules may become a party to the proceeding. Any comments,
protests, or motions to intervene must be received on or before the
specified comment date for the particular application.
    o. Filing and Service of Responsive Documents: Any filing must (1)
bear in all capital letters the title ``COMMENTS'', ``PROTEST'', or
``MOTION TO INTERVENE'' as applicable; (2) set forth in the heading the
name of the applicant and the project number of the application to
which the filing responds; (3) furnish the name, address, and telephone
number of the person protesting or intervening; and (4) otherwise
comply with the requirements of 18 CFR 385.2001 through 385.2005. All
comments, motions to intervene, or protests must set forth their
evidentiary basis. A copy of all other filings in reference to this
application must be accompanied by proof of service on all persons
listed in the service list prepared by the Commission in this
proceeding, in accordance with 18 CFR 385.2010.

    Dated: January 14, 2020.
Kimberly D. Bose,
Secretary.
[FR Doc. 2020-00923 Filed 1-21-20; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 87, Number 113 (Monday, June 13, 2022)]
[Notices]
[Pages 35846-35847]
[FR Doc No: 2022-12640]

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DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

[Docket No. FRA-2022-0046]

Palmetto Railways Request for Approval of a Railroad Safety
Program Plan and Product Safety Plan

AGENCY: Federal Railroad Administration (FRA), Department of
Transportation (DOT).

ACTION: Notice of availability and request for comments.

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SUMMARY: This document provides the public with notice that, on August
18, 2021, Palmetto Railways submitted a request for FRA approval of its
Railroad Safety Program Plan (RSPP) and Product Safety Plan (PSP) for
use of the RailSoft TrackAccess system in autonomous mode on its
Charity Church Subdivision. As this request for FRA's approval involves
a railroad's PSP, FRA is publishing this notice and inviting public
comment on the document.

DATES: Written comments must be received on or before July 28, 2022.
FRA will consider comments filed after this date to the extent
practicable.

ADDRESSES: Comments: Comments related to this Notice may be submitted
by going to https://www.regulations.gov and following the online
instructions for submitting comments.
    Instructions: All submissions must include the agency name and
docket number (FRA-2022-0046). Please note that comments submitted
online via www.regulations.gov are not

immediately posted to the docket. Several business days may elapse
after a comment has been submitted online before it is posted to the
docket.
    Privacy Act: DOT solicits comments from the public to better inform
its regulatory process. DOT posts these comments, without edit, to
www.regulations.gov, as described in the system of records notice, DOT/
ALL-14 FDMS, accessible through www.dot.gov/privacy. To facilitate
comment tracking and response, commenters are encouraged to provide
their name, or the name of their organization; however, submission of
names is completely optional. Whether or not commenters identify
themselves, all timely comments will be fully considered. If you wish
to provide comments containing proprietary or confidential information,
please contact the agency for alternate submission instructions.
    Docket: For access to the docket to read comments received, please
visit https://www.regulations.gov and follow the online instructions
for accessing the docket.

FOR FURTHER INFORMATION CONTACT: Gabe Neal, Staff Director, Signal,
Train Control, and Crossings Division, telephone:<PHONE_NUMBER>, email:
[email protected].

SUPPLEMENTARY INFORMATION: In accordance with part 236 of title 49,
Code of Federal Regulations, and sec. 20502(a) of title 49, United
States Code, this document provides the public notice that Palmetto
Railways has petitioned FRA for approval of a PSP for use of the
RailSoft TrackAccess system in autonomous mode on its Charity Church
Subdivision. FRA has assigned the petition Docket Number FRA-2022-0046.
Palmetto Railways' PSP has been placed in this docket and is available
for public inspection and comment.
    The TrackAccess system is a processor-based dispatch system
developed by RailSoft Systems to be operated in autonomous mode
(without dispatcher intervention) for low-density rail lines. RailSoft
indicates that the system provides a processor-based methodology of
requesting and issuing track authority to either qualified train crew
members or roadway workers, while increasing railroad productivity and
significantly improving the safety of train operations, roadway
workers, and other railway equipment.
    FRA is also providing public notice that Palmetto Railways' RSPP
has been placed in Docket Number FRA-2022-0046 and is available for
public inspection. FRA is not, however, accepting public comment on the
RSPP; notice regarding the availability of the RSPP is provided for
information only.
    Palmetto Railways asserts that its PSP, dated August 18, 2021,
contains the same information and analysis as the Alabama and Tennessee
River Railway's (ATN) PSP, Rev. 1, except that Palmetto Railways' PSP
has been conformed to reflect only Palmetto Railways operations. FRA
approved ATN's use of TrackAccess in autonomous mode when FRA approved
ATN's PSP, Rev. 1, on January 28, 2014, available in Docket FRA-2013-
0088. Therefore, Palmetto Railways is seeking FRA approval to use the
TrackAccess system in autonomous mode on its Charity Church
Subdivision, through approval of Palmetto Railways' PSP, dated August
18, 2021. Currently, Palmetto Railways is using the TrackAccess system
in dispatcher-assisted mode and has done so without incident since
April 2007.
    Interested parties are invited to comment on Palmetto Railways' PSP
by submitting comments to the electronic docket. Please refer to the
ADDRESSES section above for guidance on how to submit comments to the
electronic docket.

    Issued in Washington, DC.
Carolyn R. Hayward-Williams,
Director, Office of Railroad Systems and Technology.
[FR Doc. 2022-12640 Filed 6-10-22; 8:45 am]
BILLING CODE 4910-06-P


[Federal Register Volume 84, Number 155 (Monday, August 12, 2019)]
[Notices]
[Pages 39855-39856]
[FR Doc No: 2019-17212]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-P-2290]

Determination That LEVITRA (Vardenafil Hydrochloride) Tablets,
2.5 Milligrams Were Not Withdrawn From Sale for Reasons of Safety or
Effectiveness

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) has
determined that LEVITRA (vardenafil hydrochloride) tablets, 2.5
milligrams (mg), were not withdrawn from sale for reasons of safety or
effectiveness. This determination means that FDA will not begin
procedures to withdraw approval of abbreviated new drug applications
(ANDAs) that refer to this drug product, and it will allow FDA to
continue to approve ANDAs that refer to the product as long as they
meet relevant legal and regulatory requirements.

FOR FURTHER INFORMATION CONTACT: Daniel J. Ritterbeck, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6219, Silver Spring, MD 20993-0002, 301-
796-4673<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price
Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417)
(the 1984 amendments), which authorized the approval of duplicate
versions of drug products under an ANDA procedure. ANDA applicants
must, with certain exceptions, show that the drug for which they are
seeking approval contains the same active ingredient in the same
strength and dosage form as the ``listed drug,'' which is a version of
the drug that was previously approved. ANDA applicants do not have to
repeat the extensive clinical testing otherwise necessary to gain
approval of a new drug application (NDA).
    The 1984 amendments include what is now section 505(j)(7) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)), which
requires FDA to publish a list of all approved drugs. FDA publishes
this list as part of the ``Approved Drug Products With Therapeutic
Equivalence Evaluations,'' which is known generally as the ``Orange
Book.'' Under FDA regulations, drugs are removed from the list if the
Agency withdraws or suspends approval of the drug's NDA or ANDA for
reasons of safety or effectiveness or if FDA determines that the listed
drug was withdrawn from sale for reasons of safety or effectiveness (21
CFR 314.162).
    A person may petition the Agency to determine, or the Agency may
determine on its own initiative, whether a listed drug was withdrawn
from sale for reasons of safety or effectiveness. This determination
may be made at any time after the drug has been withdrawn from sale but
must be made prior to approving an ANDA that refers to the listed drug
(Sec.  314.161 (21 CFR 314.161)). FDA may not approve an ANDA that does
not refer to a listed drug.
    LEVITRA (vardenafil hydrochloride) tablets, 2.5 mg, are the subject
of NDA 021400, held by Bayer HealthCare Pharmaceuticals, Inc., and
initially approved on August 19, 2003. LEVITRA is a phosphodiesterase 5
(PDE5) inhibitor indicated for the treatment of erectile dysfunction.
LEVITRA (vardenafil hydrochloride) tablets, 2.5 mg, are currently
listed in the ``Discontinued Drug Product List'' section of the Orange
Book.
    In a letter dated March 22, 2018, Bayer HealthCare Pharmaceuticals,
Inc., notified FDA that LEVITRA (vardenafil hydrochloride) tablets, 2.5
mg, were being discontinued, and FDA moved the drug product to the
``Discontinued Drug Product List'' section of the Orange Book.
    Alembic Pharmaceuticals Limited submitted a citizen petition
received on May 9, 2019 (Docket No. FDA-2019-P-2290), under 21 CFR
10.30, requesting that the Agency determine whether LEVITRA (vardenafil
hydrochloride) tablets, 2.5 mg, were withdrawn from sale for safety or
effectiveness reasons and permit the filing of abbreviated new drug
applications (ANDAs) referencing LEVITRA (vardenafil hydrochloride)
tablets, 2.5 mg.
    After considering the citizen petition and reviewing Agency records
and based on the information we have at this time, FDA has determined
under Sec.  314.161 that LEVITRA (vardenafil hydrochloride) tablets,
2.5 mg, were not withdrawn for reasons of safety or effectiveness. The
petitioner has identified no data or other information suggesting that
LEVITRA (vardenafil hydrochloride) tablets, 2.5 mg, were withdrawn for
reasons of safety or effectiveness. We have carefully reviewed our
files for records concerning the withdrawal of LEVITRA (vardenafil
hydrochloride) tablets, 2.5 mg, from sale. We have also independently
evaluated relevant literature and data for possible postmarketing
adverse events. We have reviewed the available evidence and determined
that this drug product was

not withdrawn from sale for reasons of safety or effectiveness.
    Accordingly, the Agency will continue to list LEVITRA (vardenafil
hydrochloride) tablets, 2.5 mg, in the ``Discontinued Drug Product
List'' section of the Orange Book. The ``Discontinued Drug Product
List'' delineates, among other items, drug products that have been
discontinued from marketing for reasons other than safety or
effectiveness. FDA will not begin procedures to withdraw approval of
approved ANDAs that refer to this drug product. Additional ANDAs for
this drug product may also be approved by the Agency as long as they
meet all other legal and regulatory requirements for the approval of
ANDAs. If FDA determines that labeling for this drug product should be
revised to meet current standards, the Agency will advise ANDA
applicants to submit such labeling.

    Dated: August 7, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-17212 Filed 8-9-19; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 84, Number 59 (Wednesday, March 27, 2019)]
[Notices]
[Pages 11629-11630]
[FR Doc No: 2019-05870]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

[Summary Notice No. 2019-09]

Petition for Exemption; Summary of Petition Received; Mark Rivera
Jr.

AGENCY: Federal Aviation Administration (FAA), Department of
Transportation (DOT).

ACTION: Notice.

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SUMMARY: This notice contains a summary of a petition seeking relief
from specified requirements of Federal Aviation Regulations. The
purpose of this notice is to improve the public's awareness of, and
participation in, the FAA's exemption process. Neither publication of
this notice nor the inclusion or omission of information in the summary
is intended to affect the legal status of the petition or its final
disposition.

DATES: Comments on this petition must identify the petition docket
number and must be received on or before April 16, 2019.

ADDRESSES: Send comments identified by docket number FAA-2019-0158
using any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov and follow the online instructions for sending your
comments electronically.
     Mail: Send comments to Docket Operations, M-30; U.S.
Department of Transportation, 1200 New Jersey Avenue SE, Room W12-140,
West Building Ground Floor, Washington, DC 20590-0001.
     Hand Delivery or Courier: Take comments to Docket
Operations in Room W12-140 of the West Building Ground Floor at 1200
New Jersey Avenue SE, Washington, DC 20590-0001, between 9 a.m. and 5
p.m., Monday through Friday, except Federal holidays.
     Fax: Fax comments to Docket Operations at<PHONE_NUMBER>.
    Privacy: 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.
    Docket: Background documents or comments received may be read at
http://www.regulations.gov at any time. Follow the online instructions
for accessing the docket or go to the Docket Operations in Room W12-140
of the West Building Ground Floor at 1200 New Jersey Avenue SE,
Washington, DC 20590-0001, between 9 a.m. and 5 p.m., Monday through
Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: Michelle Ross,<PHONE_NUMBER>, Office of
Rulemaking, Federal Aviation Administration, 800 Independence Avenue
SW, Washington, DC 20591.
    This notice is published pursuant to 14 CFR 11.85.

    Issued in Washington, DC, on March 15, 2019.
Lirio Liu,
Executive Director, Office of Rulemaking.

Petition for Exemption

    Docket No.: FAA-2019-0158.
    Petitioner: Mark Rivera Jr.
    Section(s) of 14 CFR Affected: 121.311(a), (b), (c).
    Description of Relief Sought: Petitioner seeks relief from 14 CFR
part 121.311(b) to the extent required to use a non-FAA approved child
restraint system, Spirit Adjustable Positioning System (APS) Car Seat,
Model Number CSS-2400, during all phases of flight

while on board a U.S.-certificated aircraft.

[FR Doc. 2019-05870 Filed 3-26-19; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 80, Number 126 (Wednesday, July 1, 2015)]
[Notices]
[Pages 37644-37646]
[FR Doc No: 2015-16225]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Docket ID FEMA-2015-0001]

Changes in Flood Hazard Determinations

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Final notice.

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SUMMARY: New or modified Base (1-percent annual chance) Flood
Elevations (BFEs), base flood depths, Special Flood Hazard Area (SFHA)
boundaries or zone designations, and/or regulatory floodways
(hereinafter referred to as flood hazard determinations) as shown on
the indicated Letter of Map Revision (LOMR) for each of the communities
listed in the table below are finalized. Each LOMR revises the Flood
Insurance Rate Maps (FIRMs), and in some cases the Flood Insurance
Study (FIS) reports, currently in effect for the listed communities.
The flood hazard determinations modified by each LOMR will be used to
calculate flood insurance premium rates for new buildings and their
contents.

DATES: The effective date for each LOMR is indicated in the table
below.

ADDRESSES: Each LOMR is available for inspection at both the respective
Community Map Repository address listed in the table below and online
through the FEMA Map Service Center at www.msc.fema.gov.

FOR FURTHER INFORMATION CONTACT: Luis Rodriguez, Chief, Engineering
Management Branch, Federal Insurance and Mitigation Administration,
FEMA, 500 C Street SW., Washington, DC 20472,<PHONE_NUMBER>, or
(email<EMAIL_ADDRESS>or visit the FEMA Map Information
eXchange (FMIX) online at www.floodmaps.fema.gov/fhm/fmx_main.html.

SUPPLEMENTARY INFORMATION: The Federal Emergency Management Agency
(FEMA) makes the final flood hazard determinations as shown in the
LOMRs for each community listed in the table below. Notice of these
modified flood hazard determinations has been published in newspapers
of local circulation and 90 days have elapsed since that publication.
The Deputy Associate Administrator for Mitigation has resolved any
appeals resulting from this notification.
    The modified flood hazard determinations are made pursuant to

section 206 of the Flood Disaster Protection Act of 1973, 42 U.S.C.
4105, and are in accordance with the National Flood Insurance Act of
1968, 42 U.S.C. 4001 et seq., and with 44 CFR part 65.
    For rating purposes, the currently effective community number is
shown and must be used for all new policies and renewals.
    The new or modified flood hazard information is the basis for the
floodplain management measures that the community is required either to
adopt or to show evidence of being already in effect in order to remain
qualified for participation in the National Flood Insurance Program
(NFIP).
    This new or modified flood hazard information, together with the
floodplain management criteria required by 44 CFR 60.3, are the minimum
that are required. They should not be construed to mean that the
community must change any existing ordinances that are more stringent
in their floodplain management requirements. The community may at any
time enact stricter requirements of its own or pursuant to policies
established by other Federal, State, or regional entities.
    This new or modified flood hazard determinations are used to meet
the floodplain management requirements of the NFIP and also are used to
calculate the appropriate flood insurance premium rates for new
buildings, and for the contents in those buildings. The changes in
flood hazard determinations are in accordance with 44 CFR 65.4.
    Interested lessees and owners of real property are encouraged to
review the final flood hazard information available at the address
cited below for each community or online through the FEMA Map Service
Center at www.msc.fema.gov.

(Catalog of Federal Domestic Assistance No. 97.022, ``Flood
Insurance.'')

Roy E. Wright,
Deputy Associate Administrator for Insurance and Mitigation, Department
of Homeland Security, Federal Emergency Management Agency.

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                                     Location and case    Chief executive officer       Community map
         State and county                   No.                 of community             repository       Effective date of modification   Community No.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Illinois:
    Cook (FEMA Docket No.: B-      City of Palos         The Honorable Robert       City Hall, 7607 West  September 19, 2014............          170142
     1420).                         Heights (13-05-       Straz, Mayor, City of      College Drive,
                                    8093P).               Palos Heights, 7607 West   Palos Heights, IL
                                                          College Drive, Palos       60463.
                                                          Heights, IL 60463.
    DuPage (FEMA Docket No.: B-    Village of Lisle (14- The Honorable Joseph J.    Village Hall, 925     September 10, 2014............          170211
     1420).                         05-2185P).            Broda, Mayor, Village of   Burlington Avenue,
                                                          Lisle, 925 Burlington      Lisle, IL 60532.
                                                          Avenue, Lisle, IL 60532.
Indiana:
    Marshall (FEMA Docket No.: B-  City of Plymouth (14- The Honorable Mark         124 North Michigan    September 11, 2014............          180164
     1420).                         05-0926P).            Senter, Mayor, City of     Street, Plymouth,
                                                          Plymouth, 124 North        IN 46563.
                                                          Michigan Street,
                                                          Plymouth, IN 46563.
    Marshall (FEMA Docket No.: B-  Unincorporated Areas  The Honorable Kevin        112 West Jefferson,   September 11, 2014............          180443
     1420).                         of Marshall County    Overmyer, Marshall         Plymouth, IN 46563.
                                    (14-05-0926P).        County President, Board
                                                          of Commissioners, 112
                                                          West Jefferson Street,
                                                          Room 205, Plymouth, IN
                                                          46563.
Kansas: Lyon (FEMA Docket No.: B-  City of Emporia (13-  The Honorable Rob          521 Market Street,    October 10, 2014..............          200203
 1420).                             07-1700P).            Gilligan, Mayor, City of   Emporia, KS 66801.
                                                          Emporia, P.O. Box 928,
                                                          Emporia, KS 66801.
Minnesota:
    Olmsted (FEMA Docket No.: B-   City of Rochester     The Honorable Ardell F.    2122 Campus Drive,    October 17, 2014..............          275246
     1420).                         (13-05-8106P).        Brede, Mayor, City of      Suite 300,
                                                          Rochester, 201 4th         Rochester, MN
                                                          Street SE., Room 281,      55904.
                                                          Rochester, MN 55904.
    Pennington (FEMA Docket No.:   City of Thief River   The Honorable Jim Dagg,    City Hall, 405 Third  September 18, 2014............          270344
     B-1420).                       Falls (14-05-         Mayor, City of Thief       Street East, Thief
                                    0815P).               River Falls, 405 Third     River Falls, MN
                                                          Street East, Thief River   56701.
                                                          Falls, MN 56701.
    Pennington (FEMA Docket No.:   Unincorporated Areas  The Honorable Neil         201 Sherwood Avenue   September 18, 2014............          270651
     B-1420).                       of Pennington         Peterson, Pennington       South, Thief River
                                    County (14-05-        County Chairman Board of   Falls, MN 56701.
                                    0815P).               Commissioners, P.O. Box
                                                          616, Thief River Falls,
                                                          MN 56701.
Missouri:
    Buchanan (FEMA Docket No.: B-  City of St. Joseph    The Honorable Bill         1100 Frederick        September 25, 2014............          290043
     1420).                         (14-07-0148P).        Falkner, Mayor, City of    Avenue, Room 107,
                                                          Saint Joseph, 1100         St. Joseph, MO
                                                          Frederick Avenue, Room     64506.
                                                          309, St. Joseph, MO
                                                          64506.
    Cape Girardeau (FEMA Docket    City of Cape          The Honorable Harry        401 Independence      September 8, 2014.............          290458
     No.: B-1420).                  Girardeau (14-07-     Rediger, Mayor, City of    Street, Cape
                                    0463P).               Cape Girardeau, 401        Girardeau, MO
                                                          Independence Street,       63703.
                                                          Cape Girardeau, MO
                                                          63703.
New Hampshire: Hillsborough (FEMA  City of Nashua (14-   The Honorable Donnalee     229 Main Street,      September 19, 2014............          330097
 Docket No.: B-1420).               01-0876P).            Lozeau, Mayor, City of     Nashua, NH 03061.
                                                          Nashua, 229 Main Street,
                                                          Nashua, NH 03061.
Ohio:
    Logan (FEMA Docket No.: B-     City of               The Honorable Adam         135 North Detroit     September 19, 2014............          390340
     1420).                         Bellefontaine (14-    Brannon, Mayor, City of    Street,
                                    05-4416P).            Bellefontaine, 135 North   Bellefontaine, OH
                                                          Detroit Street,            43311.
                                                          Bellefontaine, OH 43311.
    Summit (FEMA Docket No.: B-    City of Hudson (14-   The Honorable William A.   27 East Main Street,  September 22, 2014............          390660
     1420).                         05-3718P).            Currin, Mayor, City of     Hudson, OH 44236.
                                                          Hudson, 115 Executive
                                                          Parkway, Suite 400,
                                                          Hudson, OH 44236.
Oregon:
    Jackson (FEMA Docket No.: B-   City of Medford (13-  The Honorable Gary         411 West 8th Street,  September 18, 2014............          410096
     1420).                         10-1490P).            Wheeler, Mayor, City of    Medford, OR 97501.
                                                          Medford, 411 West 8th
                                                          Street, Medford, OR
                                                          97501.
    Jackson (FEMA Docket No.: B-   City of Medford (14-  The Honorable Gary         411 West 8th Street,  September 15, 2014............          410096
     1420).                         10-0435P).            Wheeler, Mayor, City of    Medford, OR 97501.
                                                          Medford, 411 West 8th
                                                          Street, Medford, OR
                                                          97501.

Wisconsin: Chippewa (FEMA Docket   City of Eau Claire    Mr. Russell Van Gompel,    City Hall, 203 South  September 12, 2014............          550128
 No.: B-1420).                      (14-05-1736P).        City of Eau Claire, City   Farwell Street
                                                          Manager, 203 South         Third Floor, Eau
                                                          Farwell Street, Third      Claire, WI 54701.
                                                          Floor, Eau Claire, WI
                                                          54701.
--------------------------------------------------------------------------------------------------------------------------------------------------------

[FR Doc. 2015-16225 Filed 6-30-15; 8:45 am]
BILLING CODE 9110-12-P


[Federal Register Volume 77, Number 71 (Thursday, April 12, 2012)]
[Notices]
[Page 21982]
[FR Doc No: 2012-8824]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0001]

Cardiovascular and Renal Drugs Advisory Committee; Notice of
Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

    This notice announces a forthcoming meeting of a public advisory
committee of the Food and Drug Administration (FDA). The meeting will
be open to the public.
    Name of Committee: Cardiovascular and Renal Drugs Advisory
Committee.
    General Function of the Committee: To provide advice and
recommendations to the Agency on FDA's regulatory issues.
    Date and Time: The meeting will be held on May 23, 2012, from 8
a.m. to 5 p.m.
    Location: FDA White Oak Campus, 10903 New Hampshire Ave., Building
31 Conference Center, the Great Room (rm. 1503), Silver Spring, MD
20993-0002. Information regarding special accommodations due to a
disability, visitor parking, and transportation may be accessed at:
http://www.fda.gov/AdvisoryCommittees/default.htm; under the heading
``Resources for You,'' click on ``Public Meetings at the FDA White Oak
Campus.'' Please note that visitors to the White Oak Campus must enter
through Building 1.
    Contact Person: Kristina Toliver, Center for Drug Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
31, rm. 2417, Silver Spring, MD 20993-0002,<PHONE_NUMBER>, FAX: 301-847-
8533, email<EMAIL_ADDRESS>or FDA Advisory Committee Information
Line, 1-800-741-8138<PHONE_NUMBER> in the Washington, DC area), and
follow the prompts to the desired center or product area. Please call
the Information Line for up-to-date information on this meeting. A
notice in the Federal Register about last minute modifications that
impact a previously announced advisory committee meeting cannot always
be published quickly enough to provide timely notice. Therefore, you
should always check the Agency's Web site and call the appropriate
advisory committee hot line/phone line to learn about possible
modifications before coming to the meeting.
    Agenda: The committee will discuss supplemental new drug
application (sNDA) 202439/S-002, XARELTO (rivaroxaban), submitted by
Janssen Pharmaceuticals, Inc., to reduce the risk of thrombotic
cardiovascular events in patients with acute coronary syndrome (ACS)
[ST elevation myocardial infarction (STEMI), non-ST elevation
myocardial infarction (NSTEMI), or unstable angina (UA)] in combination
with aspirin alone or with aspirin plus clopidogrel or ticlopidine.
    FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its Web site prior to the meeting, the
background material will be made publicly available at the location of
the advisory committee meeting, and the background material will be
posted on FDA's Web site after the meeting. Background material is
available at http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee link.
    Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
Written submissions may be made to the contact person on or before May
9, 2012. Oral presentations from the public will be scheduled between
approximately 1 p.m. and 2 p.m. Those individuals interested in making
formal oral presentations should notify the contact person and submit a
brief statement of the general nature of the evidence or arguments they
wish to present, the names and addresses of proposed participants, and
an indication of the approximate time requested to make their
presentation on or before May 1, 2012. Time allotted for each
presentation may be limited. If the number of registrants requesting to
speak is greater than can be reasonably accommodated during the
scheduled open public hearing session, FDA may conduct a lottery to
determine the speakers for the scheduled open public hearing session.
The contact person will notify interested persons regarding their
request to speak by May 2, 2012.
    Persons attending FDA's advisory committee meetings are advised
that the Agency is not responsible for providing access to electrical
outlets.
    FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
physical disabilities or special needs. If you require special
accommodations due to a disability, please contact Kristina Toliver at
least 7 days in advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our Web site at http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures
on public conduct during advisory committee meetings.
    Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).

    Dated: April 9, 2012.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2012-8824 Filed 4-11-12; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 88, Number 42 (Friday, March 3, 2023)]
[Notices]
[Pages 13487-13489]
[FR Doc No: 2023-04386]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2015-0323; FMCSA-2016-0007; FMCSA-2016-0008; FMCSA-
2018-0052; FMCSA-2019-0036; FMCSA-2020-0046; FMCSA-2020-0047]

Qualification of Drivers; Exemption Applications; Epilepsy and
Seizure Disorders

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

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

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

SUMMARY: FMCSA announces its decision to renew exemptions for eight
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:  The exemptions are applicable on March 17, 2023. The exemptions
expire on March 17, 2025. Comments must be received on or before April
3, 2023.

ADDRESSES: You may submit comments identified by the Federal Docket
Management System (Docket No. FMCSA-2015-0323, Docket No. FMCSA-2016-
0007, Docket No. FMCSA-2016-0008, Docket No. FMCSA-2018-0052, Docket
No. FMCSA-2019-0036, Docket No. FMCSA-2020-0046, or Docket No. FMCSA-
2020-0047) using any of the following methods:
     Federal eRulemaking Portal: Go to www.regulations.gov/,
insert the docket number (FMCSA-2015-0323, FMCSA-2016-0007, FMCSA-2016-
0008, FMCSA-2018-0052, FMCSA-2019-0036, FMCSA-2020-0046, or FMCSA-2020-
0047) in the keyword box and click ``Search.'' Next, sort the results
by ``Posted (Newer-Older),'' choose the first notice listed, and click
on the ``Comment'' button. Follow the online instructions for
submitting comments.
     Mail: Dockets Operations; U.S. Department of
Transportation, 1200 New Jersey Avenue SE, West Building Ground Floor,
Room W12-140, Washington, DC 20590-0001.
     Hand Delivery: West Building Ground Floor, Room W12-140,
1200 New Jersey Avenue SE, Washington, DC 20590-0001 between 9 a.m. and
5 p.m. ET Monday through Friday, except Federal Holidays.
     Fax:<PHONE_NUMBER>.
    To avoid duplication, please use only one of these four methods.
See the ``Public Participation'' portion of the SUPPLEMENTARY
INFORMATION section for instructions on submitting comments.

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

SUPPLEMENTARY INFORMATION:

I. Public Participation

A. Submitting Comments

    If you submit a comment, please include the docket number for this
notice (Docket No. FMCSA-2015-0323, Docket No. FMCSA-2016-0007, Docket
No. FMCSA-2016-0008, Docket No. FMCSA-2018-0052, Docket No. FMCSA-2019-
0036, Docket No. FMCSA-2020-0046, or Docket No. FMCSA-2020-0047),
indicate the specific section of this document to which each comment
applies, and provide a reason for each suggestion or recommendation.
You may submit your comments and material online or by fax, mail, or
hand delivery, but please use only one of these means. FMCSA recommends
that you include your name and a mailing address, an email address, or
a phone number in the body of your document so that FMCSA can contact
you if there are questions regarding your submission.
    To submit your comment online, go to www.regulations.gov/, insert
the docket number (FMCSA-2015-0323, FMCSA-2016-0007, FMCSA-2016-0008,
FMCSA-2018-0052, FMCSA-2019-0036, FMCSA-2020-0046, or FMCSA-2020-0047)
in the keyword box and click ``Search.'' Next, sort the results by
``Posted (Newer-Older),'' choose the first notice listed, click the
``Comment'' button, and type your comment into the text box on the
following screen. Choose whether you are submitting your comment as an
individual or on behalf of a third party and then submit.
    If you submit your comments by mail or hand delivery, submit them
in an unbound format, no larger than 8\1/2\ by 11 inches, suitable for
copying and electronic filing. FMCSA will consider all comments and
material received during the comment period.

B. Viewing Comments

    To view comments go to www.regulations.gov. Insert the docket
number (FMCSA-2015-0323, FMCSA-2016-0007, FMCSA-2016-0008, FMCSA-2018-
0052, FMCSA-2019-0036, FMCSA-2020-0046, or FMCSA-2020-0047) in the
keyword box and click ``Search.'' Next, sort the results by ``Posted
(Newer-Older),'' choose the first notice listed, and click ``Browse
Comments.'' If you do not have access to the internet, you may view the
docket online by visiting Dockets Operations in Room W12-140 on the
ground floor of the DOT West Building, 1200 New Jersey Avenue SE,
Washington, DC 20590-0001, between 9 a.m. and 5 p.m. ET Monday through
Friday, except Federal holidays. To be sure someone is there to help
you, please call<PHONE_NUMBER> or<PHONE_NUMBER> before visiting
Dockets Operations.

C. Privacy Act

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

II. Background

    Under 49 U.S.C. 31136(e) and 31315(b), FMCSA may grant an exemption
from the FMCSRs for no longer than a 5-year period if it finds such
exemption would likely achieve a level of safety that is equivalent to,
or greater than, the level that would be achieved absent such
exemption. The statutes also allow the Agency to renew exemptions at
the end of the 5-year period. However, FMCSA grants medical exemptions
from the FMCSRs for a 2-year period to align with the maximum duration
of a driver's medical certification.
    The physical qualification standard for drivers regarding epilepsy
found in 49 CFR 391.41(b)(8) states that a person is physically
qualified to drive a CMV if that person has no established medical
history or clinical diagnosis of epilepsy or any other condition which
is likely to cause the loss of consciousness or any loss of ability to
control a CMV.
    In addition to the regulations, FMCSA has published advisory
criteria \1\ to assist Medical Examiners in determining whether drivers
with certain medical conditions are qualified to operate a CMV in
interstate commerce.
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    The eight 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
eight applicants has satisfied the renewal conditions for obtaining an
exemption from the epilepsy and seizure disorders prohibition. The
eight 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.
    As of March 17, 2023, and in accordance with 49 U.S.C. 31136(e) and
31315(b), the following eight individuals have satisfied the renewal
conditions for obtaining an exemption from the epilepsy and seizure
disorders prohibition in the FMCSRs for interstate CMV drivers:

Kenneth Elder (KY)
Demetris Furman (SD)
Scott Habeck (SD)
Todd Hines (OH)
Scott Ready, Sr. (WI)
Harold Seaton (KY)
Thomas Smutnik (PA)
Tara Vanhorne (PA)

    The drivers were included in docket number FMCSA-2015-0323, FMCSA-
2016-0007, FMCSA-2016-0008, FMCSA-2018-0052, FMCSA-2019-0036, FMCSA-
2020-0046, or FMCSA-2020-0047. Their exemptions are applicable as of
March 17, 2023 and will expire on March 17, 2025.

V. Conditions and Requirements

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

VI. Preemption

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

VII. Conclusion

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

Larry W. Minor,
Associate Administrator for Policy.
[FR Doc. 2023-04386 Filed 3-2-23; 8:45 am]
BILLING CODE 4910-EX-P