[Federal Register Volume 84, Number 195 (Tuesday, October 8, 2019)]
[Notices]
[Pages 53820-53821]
[FR Doc No: 2019-21939]

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DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

[Docket Number FRA-2019-0078]

Petition for Waiver of Compliance

    Under part 211 of title 49 Code of Federal Regulations (CFR), this
document provides the public notice that on September 9, 2019, the New
York & Lake Erie Railroad (NYLE) petitioned the Federal Railroad
Administration (FRA) to renew and extend previous waivers of compliance
from certain provisions of the Federal railroad safety regulations
contained at 49 CFR part 223. Specifically, NYLE seeks relief from the
glazing requirements in 49 CFR 223.11, Requirements for existing
locomotives, for four locomotives (NYLE 85, NYLE 308, NYLE 6758, and
NYLE 6764). These locomotives were formerly covered under Docket
Numbers FRA-2000-8267, FRA-2004-19950, and FRA-2013-0104. FRA has
assigned this petition Docket Number FRA-2019-0078.
    NYLE states that installing FRA-required glazing remains cost-
prohibitive due to the increased cost of materials and labor. NYLE
explains that the locomotives are used in rural areas at low speeds.
NYLE further states that the units are used for both freight and
passenger service in Titusville, PA, and occasionally used for freight
and passenger service in Gowanda, NY.
    A copy of the petition, as well as any written communications
concerning the petition, is available for review online at
www.regulations.gov and in person at the U.S. Department of
Transportation's (DOT) Docket Operations Facility, 1200 New Jersey
Avenue SE, W12-140, Washington, DC 20590. The Docket Operations
Facility is open from 9 a.m. to 5 p.m., Monday through Friday, except
Federal Holidays.
    Interested parties are invited to participate in these proceedings
by submitting written views, data, or comments. FRA does not anticipate
scheduling a public hearing in connection with these proceedings since
the facts do not appear to warrant a hearing. If any interested parties
desire an opportunity for oral comment and a public hearing, they
should notify FRA, in writing, before the end of the comment period and
specify the basis for their request.
    All communications concerning these proceedings should identify the
appropriate docket number and may be submitted by any of the following
methods:
     Website: http://www.regulations.gov. Follow the online
instructions for submitting comments.

     Fax:<PHONE_NUMBER>.
     Mail: Docket Operations Facility, U.S. Department of
Transportation, 1200 New Jersey Avenue SE, W12-140, Washington, DC
20590.
     Hand Delivery: 1200 New Jersey Avenue SE, Room W12-140,
Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal Holidays.
    Communications received by November 22, 2019 will be considered by
FRA before final action is taken. Comments received after that date
will be considered if practicable.
    Anyone can search the electronic form of any written communications
and comments received into any of our dockets by the name of the
individual submitting the comment (or signing the document, if
submitted on behalf of an association, business, labor union, etc.).
Under 5 U.S.C. 553(c), DOT solicits comments from the public to better
inform its processes. DOT posts these comments, without edit, including
any personal information the commenter provides, to
www.regulations.gov, as described in the system of records notice (DOT/
ALL-14 FDMS), which can be reviewed at https://www.transportation.gov/privacy. See also https://www.regulations.gov/privacyNotice for the
privacy notice of regulations.gov.

    Issued in Washington, DC.
John Karl Alexy,
Associate Administrator for Railroad Safety Chief Safety Officer.
[FR Doc. 2019-21939 Filed 10-7-19; 8:45 am]
BILLING CODE 4910-06-P


[Federal Register Volume 80, Number 103 (Friday, May 29, 2015)]
[Notices]
[Pages 30758-30759]
[FR Doc No: 2015-12980]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Agency Information Collection Activities: Requests for Comments;
Clearance of Renewed Approval of Information Collection: Certification
of Repair Stations

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice and request for comments.

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SUMMARY: In accordance with the Paperwork Reduction Act of 1995, FAA
invites public comments about our intention to request the Office of
Management and Budget (OMB) approval to renew an information
collection. Information is collected from applicants who wish to obtain
repair station certification. Applicants must submit FAA form 8310-3 to
the appropriate FAA flight standards district office for review.

DATES: Written comments should be submitted by July 28, 2015.

ADDRESSES: Send comments to the FAA at the following address: Ronda
Thompson, Room 300, Federal Aviation Administration, ASP-110, 950
L'Enfant Plaza SW., Washington, DC 20024.
    Public Comments Invited: You are asked to comment on any aspect of
this information collection, including (a) Whether the proposed
collection of

information is necessary for FAA's performance; (b) the accuracy of the
estimated burden; (c) ways for FAA to enhance the quality, utility and
clarity of the information collection; and (d) ways that the burden
could be minimized without reducing the quality of the collected
information. The agency will summarize and/or include your comments in
the request for OMB's clearance of this information collection.

FOR FURTHER INFORMATION CONTACT: Ronda Thompson at<PHONE_NUMBER>, or
by email at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:
    OMB Control Number: 2120-0682.
    Title: Certification of Repair Stations.
    Form Numbers: FAA Form 8310-3.
    Type of Review: Renewal of an information collection.
    Background: Part 145 of Title 14, Code of Federal Regulations (14
CFR) prescribes the requirements for the issuance of repair station
certificates and associated ratings to maintenance and alteration
organizations. The information requested is required from applicants
who wish repair station certification. Applicants must submit the
required data to the appropriate FAA district office for review and
acceptance/approval. If the information is satisfactory, an onsite
inspection is conducted. When all the FAR Part 145 requirements have
been met an air agency certificate and repair station operations
specifications with appropriate ratings and limitations are issued.
    Respondents: Approximately 4,625 maintenance and alteration
organizations.
    Frequency: Information is collected on occasion.
    Estimated Average Burden per Response: 8 hours.
    Estimated Total Annual Burden: 37,000 hours.

    Issued in Washington, DC on May 21, 2015.
Ronda Thompson,
FAA Information Collection Clearance Officer, IT Enterprises Business
Services Division, ASP-110.
[FR Doc. 2015-12980 Filed 5-28-15; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 77, Number 221 (Thursday, November 15, 2012)]
[Notices]
[Pages 68116-68117]
[FR Doc No: 2012-27730]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. PR13-5-000]

TEAK Texana Transmission Company, LP; Notice of Petition for Rate
Approval

    Take notice that on November 2, 2012, TEAK Texana Transmission
Company, LP (TEAK) filed a Petition for Rate Approval pursuant to
284.123(b)(2) of the Commissions regulations for firm and interruptible
natural gas transportation services, as more fully detailed in the
petition.
    Any person desiring to participate in this rate filing 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). Protests will be considered
by the Commission in determining the appropriate action to be taken,
but will not serve to make protestants parties to the proceeding. Any
person wishing to become a party must file a notice of intervention or
motion to intervene, as appropriate. Such notices, motions, or protests
must be filed on or before the date as indicated below. Anyone filing
an intervention or protest must serve a copy of that document on the
Applicant. Anyone filing an intervention or protest on or before the
intervention or protest

date need not serve motions to intervene or protests on persons other
than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov. Persons unable to file electronically should submit an
original and 7 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive email
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please email
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: 5:00 p.m. Eastern Time on Friday, November 16, 2012.

    Dated: November 8, 2012.
Kimberly D. Bose,
Secretary.
[FR Doc. 2012-27730 Filed 11-14-12; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 76, Number 144 (Wednesday, July 27, 2011)]
[Proposed Rules]
[Pages 44872-44877]
[FR Doc No: 2011-18957]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 870

[Docket No. FDA-2011-N-0522]

Effective Date of Requirement for Premarket Approval for an
Implantable Pacemaker Pulse Generator

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

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SUMMARY: The Food and Drug Administration (FDA) is proposing to require
the filing of a premarket approval application (PMA) or a notice of
completion of a product development protocol (PDP) for the class III
preamendments device implantable pacemaker pulse generator. The Agency
is also summarizing its proposed findings regarding the degree of risk
of illness or injury designed to be eliminated or reduced by requiring
the device to meet the statute's approval requirements and the benefits
to the public from the use of the device. In addition, FDA is
announcing the opportunity for interested persons to request that the
Agency change the classification of the aforementioned device based on
new information. This action implements certain statutory requirements.

DATES: Submit either electronic or written comments by October 25,
2011. Submit requests for a change in classification by August 11,
2011. FDA intends that, if a final rule based on this proposed rule is
issued, anyone who wishes to continue to market the device will need to
submit a PMA within 90 days of the effective date of the final rule.
Please see section XIII of this document for the effective date of any
final rule that may publish based on this proposal.

ADDRESSES: You may submit comments, identified by Docket No. FDA-2011-
N-0522, by any of the following methods:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments.

Written Submissions

    Submit written submissions in the following ways:
     FAX:<PHONE_NUMBER>.
     Mail/Hand delivery/Courier (for paper, disk, or CD-ROM
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
    Instructions: All submissions received must include the Agency name
and Docket Number for this rulemaking. All comments received may be
posted without change to http://www.regulations.gov, including any
personal information provided. For additional information on submitting
comments, see the ``Comments'' heading of the SUPPLEMENTARY INFORMATION
section of this document.
    Docket: For access to the docket to read background documents or
comments received, go to http://www.regulations.gov and insert the
docket number, found in brackets in the heading of this document, into
the ``Search'' box and follow the prompts and/or go to the Division of
Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Elias Mallis, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 1538, Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background--Regulatory Authorities

    The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended
by the Medical Device Amendments of 1976 (the 1976 amendments) (Pub. L.
94-295), the Safe Medical Devices Act of 1990 (the SMDA) (Pub. L. 101-
629), and the Food and Drug Administration Modernization Act of 1997
(FDAMA) (Pub. L. 105-115), the Medical Device User Fee and
Modernization Act of 2002 (Pub. L. 107-250), the Medical Devices
Technical Corrections Act of 2004 (Pub. L. 108-214), and the Food and
Drug Administration Amendments Act of 2007 (Pub. L. 110-85), establish
a comprehensive system for the regulation of medical devices intended
for human use. Section 513 of the FD&C Act (21 U.S.C. 360c) established
three categories (classes) of devices, reflecting the regulatory
controls needed to provide reasonable assurance of their safety and
effectiveness. The three categories of devices are class I (general
controls), class II (special controls), and class III (premarket
approval).
    Under section 513 of the FD&C Act, devices that were in commercial
distribution before the enactment of the 1976 amendments, May 28, 1976
(generally referred to as preamendments devices), are classified after
FDA has: (1) Received a recommendation from a device classification
panel (an FDA advisory committee); (2) published the panel's
recommendation for comment, along with a proposed regulation
classifying the device; and (3) published a final regulation
classifying the device. FDA has classified most preamendments devices
under these procedures.
    Devices that were not in commercial distribution prior to May 28,
1976 (generally referred to as postamendments devices), are
automatically classified by section 513(f) of the FD&C Act into class
III without any FDA rulemaking process. Those devices remain in class
III and require premarket approval unless, and until, the device is
reclassified into class I or II or FDA issues an order finding the
device to be substantially equivalent, in accordance with section
513(i) of the FD&C Act, to a predicate device that does not require
premarket approval. The Agency determines whether new devices are
substantially equivalent to predicate devices by means of premarket
notification procedures in section 510(k) of the FD&C Act (21 U.S.C.
360(k)) and part 807 (21 CFR Part 807).
    A preamendments device that has been classified into class III may
be marketed by means of premarket notification procedures (510(k)
process) without submission of a PMA until FDA issues a final
regulation under section 515(b) of the FD&C Act (21 U.S.C. 360e(b))
requiring premarket approval. Section 515(b)(1) of the FD&C Act
establishes the requirement that a preamendments device that FDA has
classified into class III is subject to premarket approval. A
preamendments class III device may be commercially distributed without
an approved PMA or a notice of completion of a PDP until 90 days after
FDA issues a final rule requiring premarket approval for the device, or
30 months after final classification of the device under section 513 of
the FD&C Act, whichever is later. Also, a preamendments device subject
to the rulemaking procedure under section 515(b) of the FD&C Act is not
required to have an approved investigational device exemption (IDE)
(see part 812 (21 CFR Part 812)) contemporaneous with its interstate
distribution until the date identified by FDA in the final rule
requiring the submission of a PMA for the device. At that time, an IDE
is required only if a PMA has not been submitted or a PDP completed.
    Section 515(b)(2)(A) of the FD&C Act provides that a proceeding to
issue a final rule to require premarket approval shall be initiated by
publication of a notice of proposed rulemaking containing: (1) The
regulation; (2) proposed findings with respect to the degree of risk of
illness or injury designed to be eliminated or reduced by requiring the
device to have an approved PMA or a declared completed PDP and the
benefit to the public from the use of the device; (3) an opportunity
for the submission of comments on the proposed rule and the proposed
findings; and (4) an opportunity to request a change in the
classification of the device based on new information relevant to the
classification of the device.
    Section 515(b)(2)(B) of the FD&C Act provides that if FDA receives
a request for a change in the classification of the device within 15
days of the publication of the notice, FDA shall, within 60 days of the
publication of the notice, consult with the appropriate FDA advisory
committee and publish a notice denying the request for change in
reclassification or announcing its intent to initiate a proceeding to
reclassify the device under section 513(e) of the FD&C Act.
    Section 515(b)(3) of the FD&C Act provides that FDA shall, after
the close of the comment period on the proposed rule and consideration
of any comments received, issue a final rule to require premarket
approval or publish a document terminating the proceeding together with
the reasons for such termination. If FDA terminates the proceeding, FDA
is required to initiate reclassification of the device under section
513(e) of the FD&C Act, unless the reason for termination is that the
device is a banned device under section 516 of the FD&C Act (21 U.S.C.
360f).
    If a proposed rule to require premarket approval for a
preamendments device is finalized, section 501(f)(2)(B) of the FD&C Act
(21 U.S.C. 351(f)(2)(B)) requires that a PMA or notice of completion of
a PDP for any such device be filed within 90 days of the date of
issuance of the final rule or 30 months after the final classification
of the device under section 513 of the FD&C Act, whichever is later. If
a PMA or notice of completion of a PDP is not filed by the later of the
two dates, commercial distribution of the device is

required to cease since the device would be deemed adulterated under
section 501(f) of the FD&C Act.
    The device may, however, be distributed for investigational use if
the manufacturer, importer, or other sponsor of the device complies
with the IDE regulations. If a PMA or notice of completion of a PDP is
not filed by the later of the two dates, and the device does not comply
with IDE regulations, the device is deemed to be adulterated within the
meaning of section 501(f)(1)(A) of the FD&C Act, and subject to seizure
and condemnation under section 304 of the FD&C Act (21 U.S.C. 334) if
its distribution continues. Shipment of devices in interstate commerce
will be subject to injunction under section 302 of the FD&C Act (21
U.S.C. 332), and the individuals responsible for such shipment will be
subject to prosecution under section 303 of the FD&C Act (21 U.S.C.
333). In the past, FDA has requested that manufacturers take action to
prevent the further use of devices for which no PMA or PDP has been
filed and may determine that such a request is appropriate for the
class III devices that are the subjects of this regulation.
    The FD&C Act does not permit an extension of the 90-day period
after issuance of a final rule within which an application or a notice
is required to be filed. The House Report on the 1976 amendments states
that: [t]he thirty month grace period afforded after classification of
a device into class III * * * is sufficient time for manufacturers and
importers to develop the data and conduct the investigations necessary
to support an application for premarket approval (H. Rept. 94-853, 94th
Cong., 2d sess. 42 (1976)).
    The SMDA added section 515(i) to the FD&C Act requiring FDA to
review the classification of preamendments class III devices for which
no final rule requiring the submission of PMAs has been issued, and to
determine whether or not each device should be reclassified into class
I or class II or remain in class III. For devices remaining in class
III, the SMDA directed FDA to develop a schedule for issuing
regulations to require premarket approval. The SMDA does not, however,
prevent FDA from proceeding immediately to rulemaking under section
515(b) of the FD&C Act on specific devices, in the interest of public
health, independent of the procedures of section 515(i). Proceeding
directly to rulemaking under section 515(b) of the FD&C Act is
consistent with Congress' objective in enacting section 515(i), i.e.,
that preamendments class III devices for which PMAs have not been
previously required either be reclassified to class I or class II or be
subject to the requirements of premarket approval. Moreover, in this
proposal, interested persons are being offered the opportunity to
request reclassification of any of the devices.

II. Dates New Requirements Apply

    In accordance with section 515(b) of the FD&C Act, FDA is proposing
to require that a PMA or a notice of completion of a PDP be filed with
the Agency for class III devices within 90 days after issuance of any
final rule based on this proposal. An applicant whose device was
legally in commercial distribution before May 28, 1976, or whose device
has been found to be substantially equivalent to such a device, will be
permitted to continue marketing such class III devices during FDA's
review of the PMA or notice of completion of the PDP. FDA intends to
review any PMA for the device within 180 days, and any notice of
completion of a PDP for the device within 90 days of the date of
filing. FDA cautions that under section 515(d)(1)(B)(i) of the FD&C
Act, the Agency may not enter into an agreement to extend the review
period for a PMA beyond 180 days unless the Agency finds that ``the
continued availability of the device is necessary for the public
health.''
    FDA intends that under Sec.  812.2(d), the preamble to any final
rule based on this proposal will state that, as of the date on which
the filing of a PMA or a notice of completion of a PDP is required to
be filed, the exemptions from the requirements of the IDE regulations
for preamendments class III devices in Sec.  812.2(c)(1) and (c)(2)
will cease to apply to any device that is: (1) Not legally on the
market on or before that date, or (2) legally on the market on or
before that date but for which a PMA or notice of completion of a PDP
is not filed by that date, or for which PMA approval has been denied or
withdrawn.
    If a PMA or notice of completion of a PDP for a class III device is
not filed with FDA within 90 days after the date of issuance of any
final rule requiring premarket approval for the device, commercial
distribution of the device must cease. The device may be distributed
for investigational use only if the requirements of the IDE regulations
are met. The requirements for significant risk devices include
submitting an IDE application to FDA for its review and approval. An
approved IDE is required to be in effect before an investigation of the
device may be initiated or continued under Sec.  812.30. FDA,
therefore, cautions that IDE applications should be submitted to FDA at
least 30 days before the end of the 90-day period after the issuance of
the final rule to avoid interrupting investigations.

III. Proposed Findings With Respect to Risks and Benefits

    As required by section 515(b) of the FD&C Act, FDA is publishing
its proposed findings regarding: (1) The degree of risk of illness or
injury designed to be eliminated or reduced by requiring that this
device have an approved PMA or a declared completed PDP, and (2) the
benefits to the public from the use of the device.
    These findings are based on the reports and recommendations of the
advisory committees (panels) for the classification of these devices
along with information submitted in response to the 515(i) Order that
published in the Federal Register of April 9, 2009 (74 FR 16214), and
any additional information that FDA has encountered. Additional
information regarding the risks as well as classification associated
with these device types can be found in the following proposed and
final rules published in the Federal Register on the following dates:
March 9, 1979 (44 FR 13373); February 5, 1980 (45 FR 7907); and May 11,
1987 (52 FR 17736).

IV. Device Subject to This Proposal--Implantable Pacemaker Pulse
Generator (21 CFR 870.3610)

A. Identification

    An implantable pacemaker pulse generator is a device that has a
power supply and electronic circuits that produce a periodic electrical
pulse to stimulate the heart. The power supply may be a pacemaker
battery although, as discussed in section X of this document, FDA has
no record of the pacemaker battery ever being marketed. This device is
used as a substitute for the heart's intrinsic pacing system to correct
both intermittent and continuous cardiac rhythm disorders. This device
may include triggered, inhibited, and asynchronous devices implanted in
the human body.

B. Summary of Data

    The Cardiovascular Devices Panel recommended that the implantable
pacemaker pulse generator (which includes the internal pacemaker
battery) be classified into class III because the device is implanted
and life-supporting and presented a potential unreasonable risk of
illness or injury. The power supply may be a pacemaker battery
although, as discussed under section X of this document, FDA has no
record of the pacemaker battery ever being marketed. The panel
indicated that

although a proposed standard had been written, it did not cover all of
the performance characteristics of the device and that this standard
was not widely accepted. The panel indicated that general controls
alone would not provide sufficient control over the performance
characteristics of the device and that sufficient scientific and
medical data did not exist to establish a complete standard to assure
the safety and effectiveness of particular aspects of the device.
Consequently, the panel believed that premarket approval was necessary
to assure the safety and effectiveness of the device. FDA continues to
agree with the panel's recommendation.

C. Risks to Health

1. Failure To Pace
    A failure of the electronic circuitry or early battery depletion
can cause failure to pace the patient's heart. Failure to pace could
result in a dangerously slow heart rate (or in extreme cases, no heart
beat at all), which could result in weakness, dizziness, fainting or
even death.
2. Improper Pacing Rate
    An electronic circuit failure or an inaccurate rate controller in
the circuit can cause improper pacing rates, which could be too fast or
too slow. Improper pacing rates may result in symptoms of fatigue,
chest discomfort, shortness of breath, dizziness, or fainting.
3. Arrhythmias
    A sensing failure of the pacemaker during vulnerable periods of the
cardiac cycle can induce cardiac arrhythmias, in particular,
dangerously fast arrhythmias. In this case, dangerously fast
arrhythmias may lead to chest pain, shortness of breath, dizziness,
fainting or even death.
4. Improper Sensing
    Electromagnetic interference with pacemaker electronics, loose
connections, or sensing circuitry failures may cause improper sensing
by the pacemaker, which can lead to failure to pace, improper pacing
cycle, and/or arrhythmias.
5. Tissue Damage
    If the materials, surface finish, or cleanliness of this device are
inadequate, tissue damage can occur.
6. Unintended Stimulation
    Pacing pulses may stimulate unintended nerve or muscle, resulting
in uncomfortable contractions of the chest wall muscles or of the
diaphragm.
7. Development of Pacemaker Syndrome
    Pacemaker syndrome may result from suboptimal atrioventricular (AV)
synchrony or AV dyssynchrony; this could cause an uncomfortable cardiac
awareness including palpitations, fatigue, dizziness, shortness of
breath and near-fainting.
8. Other Complications
    Other risks of pacemaker implantation include infection, erosion,
fibrotic tissue formation, body rejection phenomena, hematoma,
myopotential sensing, and additional surgery for replacement. Risks are
also associated with pacemaker lead implantation. These are not
discussed in this document.

V. PMA Requirements

    A PMA for this device must include the information required by
section 515(c)(1) of the FD&C Act. Such a PMA should also include a
detailed discussion of the risks identified previously, as well as a
discussion of the effectiveness of the device for which premarket
approval is sought. In addition, a PMA must include all data and
information on the following: (1) Any risks known, or that should be
reasonably known, to the applicant that have not been identified in
this document; (2) the effectiveness of the device that is the subject
of the application; and (3) full reports of all preclinical and
clinical information from investigations on the safety and
effectiveness of the device for which premarket approval is sought.
    A PMA must include valid scientific evidence to demonstrate
reasonable assurance of the safety and effectiveness of the device for
its intended use (see 21 CFR 860.7(c)(2)). Valid scientific evidence is
``evidence from well-controlled investigations, partially controlled
studies, studies and objective trials without matched controls, well-
documented case histories conducted by qualified experts, and reports
of significant human experience with a marketed device, from which it
can fairly and responsibly be concluded by qualified experts that there
is reasonable assurance of the safety and effectiveness of a device
under its conditions of use. * * * Isolated case reports, random
experience, reports lacking sufficient details to permit scientific
evaluation, and unsubstantiated opinions are not regarded as valid
scientific evidence to show safety or effectiveness.'' (21 CFR
860.7(c)(2)).

VI. PDP Requirements

    A PDP for this device may be submitted in lieu of a PMA, and must
follow the procedures outlined in section 515(f) of the FD&C Act. A PDP
must provide: (1) A description of the device, (2) preclinical trial
information (if any), (3) clinical trial information (if any), (4) a
description of the manufacturing and processing of the device, (5) the
labeling of the device, and (6) all other relevant information about
the device. In addition, the PDP must include progress reports and
records of the trials conducted under the protocol on the safety and
effectiveness of the device for which the completed PDP is sought.

VII. Comments

    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES), either electronic or written comments regarding this
document. It is only necessary to send one set of comments. It is no
longer necessary to send two copies of mailed comments. Identify
comments with the docket number found in brackets in the heading of
this document. Received comments may be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday.

VIII. Opportunity To Request a Change in Classification

    Before requiring the filing of a PMA or notice of completion of a
PDP for a device, FDA is required by section 515(b)(2)(A)(i) through
(b)(2)(A)(iv) of the FD&C Act and 21 CFR 860.132 to provide an
opportunity for interested persons to request a change in the
classification of the device based on new information relevant to the
classification. Any proceeding to reclassify the device will be under
the authority of section 513(e) of the FD&C Act.
    A request for a change in the classification of this device is to
be in the form of a reclassification petition containing the
information required by Sec.  860.123 (21 CFR 860.123), including new
information relevant to the classification of the device.
    The Agency advises that to ensure timely filing of any such
petition, any request should be submitted to the Division of Dockets
Management (see ADDRESSES) and not to the address provided in Sec.
860.123(b)(1). If a timely request for a change in the classification
of these devices is submitted, the Agency will, within 60 days after
receipt of the petition, and after consultation with the appropriate
FDA resources, publish an order in the Federal Register that either
denies the request or gives notice of its intent to initiate a change
in the classification of the device in accordance with section

513(e) of the FD&C Act and 21 CFR 860.130 of the regulations.

IX. Environmental Impact

    The Agency has determined under 21 CFR 25.30(h) that this action is
of a type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.

X. Analysis of Impacts

    FDA has examined the impacts of the proposed rule under Executive
Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5
U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L.
104-4). Executive Orders 12866 and 13563 direct Agencies to assess all
costs and benefits of available regulatory alternatives and, when
regulation is necessary, to select regulatory approaches that maximize
net benefits (including potential economic, environmental, public
health and safety, and other advantages; distributive impacts; and
equity). The Agency believes that this proposed rule is not a
significant regulatory action as defined by Executive Order 12866.
    The Regulatory Flexibility Act requires Agencies to analyze
regulatory options that would minimize any significant impact of a rule
on small entities. There have been no 510(k) submissions for
implantable pacemaker devices since 1999, there is no record of
pacemaker batteries ever being marketed, and both of these devices are
in a state of disuse. Accordingly, FDA has concluded that there is
little or no interest in marketing these devices in the future.
Therefore, the Agency proposes to certify that the proposed rule, if
issued as a final rule, would not have a significant economic impact on
a substantial number of small entities. We specifically request
detailed comment regarding the appropriateness of our assumptions
regarding the potential economic impact of this proposed rule.
    Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires
that Agencies prepare a written statement, which includes an assessment
of anticipated costs and benefits, before proposing ``any rule that
includes any Federal mandate that may result in the expenditure by
State, local and tribal governments, in the aggregate, or by the
private sector, of $100,000,000 or more (adjusted annually for
inflation) in any one year.'' The current threshold after adjustment
for inflation is $136 million, using the most current (2010) Implicit
Price Deflator for the Gross Domestic Product. FDA does not expect this
proposed rule to result in any 1-year expenditure that would meet or
exceed this amount.
    This proposed rule, if issued as a final rule, would be likely to
have no significant impact. We base this determination on an analysis
of our Registration and Listing, 510(k) and Premarket Approval
Application (PMA) database information. There have been no 510(k)
submissions for implantable pacemaker pulse generators since 1999, with
the exception of one 510(k) submission cleared in 2001 that was
erroneously coded as an implantable pacemaker pulse generator (product
code DXY), but is actually for an external pacemaker and is being
corrected. Current pacemakers have newer features and capabilities that
have rendered them not substantially equivalent to the devices cleared
under 510(k) prior to 1999, which are obsolete. Current pacemakers are
marketed under a PMA; in some cases the product code DXY has been
erroneously applied. In addition, there have been no valid 510(k)
submissions for pacemaker batteries for implantable pacemakers, which
also fall under the product code DSZ also under 21 CFR 870.3610. Two
510(k) submissions have been received for DSZ devices since 1976, but
they are believed to be miscoded. The Agency has no record of pacemaker
batteries ever being marketed.
    This information is summarized in table 1 of this document.

                                           Table 1--Summary of Electronic Registration and Listing Information
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Replaced by  approved
            Device name                   Product code           510(k) or PMA?           Last listed           Last marketed            technology?
--------------------------------------------------------------------------------------------------------------------------------------------------------
Implantable Pacemaker Pulse          DXY...................  Both..................  2011.................  1990s................  Yes.\1\
 Generator.
Pacemaker Battery..................  DSZ...................  510(k)................  No Record............  No Record............  No.\2\
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ Implantable pacemaker pulse generators have been submitted as PMAs since the early 1980s. The product code DXY has been erroneously applied to many
  of these PMA products. The last 510(k) submission for a DXY device was cleared in 1999.
\2\ Pacemaker batteries are not separately marketed products. They are internal to implantable pacemakers.

    Based on our review of electronic product registration and listing
and other data, FDA concludes that there is currently little or no
interest in marketing the affected devices and that the proposed rule
would not have a significant economic impact. We specifically request
detailed comment regarding the appropriateness of our assumptions
regarding the potential economic impact of this proposed rule.

XI. Federalism

    FDA has analyzed this proposed rule in accordance with the
principles set forth in Executive Order 13132. FDA has determined that
the proposed rule, if finalized, would not contain policies that would
have substantial direct effects on the States, on the relationship
between the National Government and the States, or on the distribution
of power and responsibilities among the various levels of government.
Accordingly, the Agency tentatively concludes that the proposed rule
does not contain policies that have federalism implications as defined
in the Executive order and, consequently, a federalism summary impact
statement is not required.

XII. Paperwork Reduction Act of 1995

    This proposed rule refers to currently approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in part 812 are currently approved under OMB
Control No. 0910-0078; the collections of information in part 807,
subpart E are currently approved under OMB Control No. 0910-0120; the
collections of information in 21 CFR Part 814, subpart B are currently
approved under OMB Control No. 0910-0231; and the collections of
information under 21 CFR Part 801 are currently approved under OMB
Control No. 0910-0485.

XIII. Proposed Effective Date

    FDA is proposing that any final rule based on this proposal become
effective on the date of its publication in the Federal Register or at
a later date if stated in the final rule.

List of Subjects in 21 CFR Part 870

    Medical devices.
    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, it is
proposed that 21 CFR Part 870 be amended as follows:

PART 870--CARDIOVASCULAR DEVICES

    1. The authority citation for 21 CFR Part 870 continues to read as
follows:

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

    2. Section 870.3610 is amended by revising paragraphs (a) and (c)
to read as follows:

Sec.  870.3610  Implantable pacemaker pulse generator.

    (a) Identification. An implantable pacemaker pulse generator is a
device that has a power supply and electronic circuits that produce a
periodic electrical pulse to stimulate the heart. This device is used
as a substitute for the heart's intrinsic pacing system to correct both
intermittent and continuous cardiac rhythm disorders. This device may
include triggered, inhibited, and asynchronous modes and is implanted
in the human body.
* * * * *
    (c) Date PMA or notice of completion of PDP is required. A PMA or
notice of completion of a PDP is required to be filed with the Food and
Drug Administration on or before [A DATE WILL BE ADDED 90 DAYS AFTER
DATE OF PUBLICATION OF A FUTURE FINAL RULE IN THE FEDERAL REGISTER],
for any implantable pacemaker pulse generator that was in commercial
distribution before May 28, 1976, or that has, on or before [A DATE
WILL BE ADDED 90 DAYS AFTER DATE OF PUBLICATION OF A FUTURE FINAL RULE
IN THE FEDERAL REGISTER], been found to be substantially equivalent to
any implantable pacemaker pulse generator that was in commercial
distribution before May 28, 1976. Any other implantable pacemaker pulse
generator shall have an approved PMA or declared completed PDP in
effect before being placed in commercial distribution.

    Dated: July 22, 2011.
 Nancy K. Stade,
 Deputy Director for Policy, Center for Devices and Radiological
Health.
[FR Doc. 2011-18957 Filed 7-26-11; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register: December 2, 2008 (Volume 73, Number 232)]
[Notices]
[Page 73324]
[DOCID:fr02de08-65]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket Nos. RM08-3-002]

North American Electric Reliability Corporation; Notice of Filing

November 24, 2008.
    Take notice that on November 17, 2008, the North American
Electricity Reliability Corporation (NERC) filed a compliance filing,
requiring NERC to submit a timeline for developing and filing a
modification to Requirement R9.3.5 of Reliability Standard NUC-001-1,
pursuant to paragraph 107 of the Commission's Order No. 716.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed on or before the comment date.
Anyone filing a motion to intervene or protest must serve a copy of
that document on the Applicant and all the parties in this proceeding.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://
www.ferc.gov. Persons unable to file electronically should submit an
original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: 5 p.m. Eastern Time on December 8, 2008.

Kimberly D. Bose,
Secretary.
 [FR Doc. E8-28487 Filed 12-1-08; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 81, Number 42 (Thursday, March 3, 2016)]
[Notices]
[Pages 11205-11206]
[FR Doc No: 2016-04652]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings

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

Filings Instituting Proceedings

    Docket Numbers: PR16-12-001.
    Applicants: Columbia Gas of Maryland, Inc.
    Description: Tariff filing per 284.123(b)(1): PR16-12 CMD Amended
SOC to be effective 1/1/2015; Filing Type: 1000.
    Filed Date: 2/22/16.
    Accession Number:<PHONE_NUMBER>23.
    Comments/Protests Due: 5 p.m. ET 3/14/16.

    Docket Numbers: PR16-13-001.
    Applicants: Columbia Gas of Ohio, Inc.
    Description: Tariff filing per 284.123(b)(1): COH Amended SOC PR16-
13 to be effective 4/30/2015; Filing Type: 1000.
    Filed Date: 2/22/16.
    Accession Number:<PHONE_NUMBER>81.
    Comments/Protests Due: 5 p.m. ET 3/14/16.

    Docket Numbers: PR16-26-000.
    Applicants: Enable Oklahoma Intrastate Transmission, LLC.
    Description: Tariff filing per 284.123(b)(2) +(g): EOIT Petition
for Section 311 Rate Approval to be effective 4/1/2016; Filing Type:
1310.
    Filed Date: 2/19/16.
    Accession Number:<PHONE_NUMBER>34.
    Comments Due: 5 p.m. ET 3/11/16.
    284.123(g) Protests Due: 5 p.m. ET 4/19/16.

    Docket Numbers: RP16-622-000.
    Applicants: Natural Gas Pipeline Company of America.
    Description: Sec.  4(d) Rate Filing: BG Energy Negotiated Rate to
be effective 4/1/2016.
    Filed Date: 2/23/16.
    Accession Number: 20160223-5062.
    Comments Due: 5 p.m. ET 3/7/16.

    Docket Numbers: RP16-623-000.
    Applicants: Natural Gas Pipeline Company of America.
    Description: Sec.  4(d) Rate Filing: Nicor Negotiated Rate to be
effective 4/1/2016.
    Filed Date: 2/23/16.
    Accession Number: 20160223-5078.
    Comments Due: 5 p.m. ET 3/7/16.

    Docket Numbers: RP16-624-000.
    Applicants: MoGas Pipeline LLC.
    Description: Sec.  4(d) Rate Filing: MoGas Negotiated Rate
Agreement Waynesville Filing to be effective 3/1/2016.

    Filed Date: 2/23/16.
    Accession Number: 20160223-5087.
    Comments Due: 5 p.m. ET 3/7/16.

    Docket Numbers: RP16-625-000.
    Applicants: Northern Natural Gas Company.
    Description: Sec.  4(d) Rate Filing: 20160222 Housekeeping Filing
to be effective 4/1/2016.
    Filed Date: 2/23/16.
    Accession Number: 20160223-5149.
    Comments Due: 5 p.m. ET 3/7/16.

    Docket Numbers: RP16-626-000.
    Applicants: Southern Star Central Gas Pipeline, Inc.
    Description: Sec.  4(d) Rate Filing: Fuel Filing--Eff. April 1,
2016 to be effective 4/1/2016.
    Filed Date: 2/24/16.
    Accession Number: 20160224-5026.
    Comments Due: 5 p.m. ET 3/7/16.

    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and Sec.  385.214) on or
before 5:00 p.m. Eastern time on the specified date(s). Protests may be
considered, but intervention is necessary to become a party to the
proceeding.

Filings in Existing Proceedings

    Docket Numbers: RP16-597-001.
    Applicants: Tallgrass Interstate Gas Transmission, L.
    Description: Compliance filing Compliance to 587-W Amendment to be
effective 4/1/2016.
    Filed Date: 2/23/16.
    Accession Number: 20160223-5105.
    Comments Due: 5 p.m. ET 3/7/16.

    Docket Numbers: RP16-598-001.
    Applicants: Rockies Express Pipeline LLC.
    Description: Compliance filing Compliance with Order No. 587-W
Amendment to be effective 4/1/2016.
    Filed Date: 2/23/16.
    Accession Number: 20160223-5104.
    Comments Due: 5 p.m. ET 3/7/16.

    Docket Numbers: RP16-599-001.
    Applicants: Trailblazer Pipeline Company LLC.
    Description: Compliance filing Order 587-W Amendment to be
effective 4/1/2016.
    Filed Date: 2/23/16.
    Accession Number: 20160223-5109.
    Comments Due: 5 p.m. ET 3/7/16.

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

    Dated: February 24, 2016.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2016-04652 Filed 3-2-16; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 86, Number 98 (Monday, May 24, 2021)]
[Notices]
[Page 27847]
[FR Doc No: 2021-10847]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER21-1921-000]

Citadel Energy Marketing LLC; Supplemental Notice That Initial
Market-Based Rate Filing Includes Request for Blanket Section 204
Authorization

    This is a supplemental notice in the above-referenced Citadel
Energy Marketing LLC's application for market-based rate authority,
with an accompanying rate tariff, noting that such application includes
a request for blanket authorization, under 18 CFR part 34, of future
issuances of securities and assumptions of liability.
    Any person desiring to intervene or to protest should file with the
Federal Energy Regulatory Commission, 888 First Street NE, Washington,
DC 20426, in accordance with Rules 211 and 214 of the Commission's
Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone
filing a motion to intervene or protest must serve a copy of that
document on the Applicant.
    Notice is hereby given that the deadline for filing protests with
regard to the applicant's request for blanket authorization, under 18
CFR part 34, of future issuances of securities and assumptions of
liability, is June 7, 2021.
    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 may mail similar pleadings to
the Federal Energy Regulatory Commission, 888 First Street NE,
Washington, DC 20426. Hand delivered submissions in docketed
proceedings should be delivered to Health and Human Services, 12225
Wilkins Avenue, Rockville, Maryland 20852.
    In addition to publishing the full text of this document in the
Federal Register, the Commission provides all interested persons an
opportunity to view and/or print the contents of this document via the
internet through the Commission's Home Page (http://www.ferc.gov) using
the ``eLibrary'' link. Enter the docket number excluding the last three
digits in the docket number field to access the document. At this time,
the Commission has suspended access to the Commission's Public
Reference Room, due to the proclamation declaring a National Emergency
concerning the Novel Coronavirus Disease (COVID-19), issued by the
President on March 13, 2020. For assistance, contact the Federal Energy
Regulatory Commission at<EMAIL_ADDRESS>or call toll-free,
(886) 208-3676 or TYY,<PHONE_NUMBER>.

    Dated: May 17, 2021.
Debbie-Anne A. Reese,
Deputy Secretary.
[FR Doc. 2021-10847 Filed 5-21-21; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 77, Number 40 (Wednesday, February 29, 2012)]
[Notices]
[Pages 12360-12361]
[FR Doc No: 2012-4869]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2012-0050]

Qualification of Drivers; Exemption Applications; Epilepsy and
Seizure Disorders

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

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

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

SUMMARY: FMCSA announces receipt of applications from 5 individuals for
an exemption from the prohibition against persons with a clinical
diagnosis of epilepsy or any other condition which is likely to cause a
loss of consciousness or any loss of ability to operate a commercial
motor vehicle (CMV) from operating CMVs in interstate commerce. If
granted, the exemptions would enable these individuals with seizure
disorders to operate CMVs in interstate commerce.

DATES: Comments must be received on or before March 30, 2012.

ADDRESSES: You may submit comments bearing the Federal Docket
Management System (FDMS) Docket ID FMCSA-2012-0050 using any of the
following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the on-line instructions for submitting
comments.
     Mail: Docket Management Facility; U.S. Department of
Transportation, 1200 New Jersey Avenue SE., West Building Ground Floor,
Room W12-140, Washington, DC 20590-0001.
     Hand Delivery: West Building Ground Floor, Room W12-140,
1200 New Jersey Avenue SE., Washington, DC, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal Holidays.
     Fax: 1-202-493-2251.
    Each submission must include the Agency name and the docket ID for
this Notice. Note that DOT posts all comments received without change
to http://www.regulations.gov, including any personal information
included in a comment. Please see the Privacy Act heading below.
    Docket: For access to the docket to read background documents or
comments, go to http://www.regulations.gov at any time or Room W12-140
on the ground level of the West Building, 1200 New Jersey Avenue SE.,
Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays. The FDMS is available 24 hours each day, 365
days each year. If you want acknowledgment that we received your
comments, please include a self-addressed, stamped envelope or postcard
or print the acknowledgement page that appears after submitting
comments on-line.
    Privacy Act: Anyone may search the electronic form of all comments
received into any of our dockets by the name of the individual
submitting the comment (or of the person signing the comment, if
submitted on behalf of an association, business, labor union, etc.).
You may review the DOT's complete Privacy Act Statement in the Federal
Register published on April 11, 2000 (65 FR 19477-78; Apr. 11, 2000).
This information is also available at http://Docketinfo.dot.gov.

FOR FURTHER INFORMATION CONTACT: Elaine Papp, Chief, Medical Programs
Division<PHONE_NUMBER>, or via email at<EMAIL_ADDRESS>or by
letter FMCSA, Room W64-113, Department of Transportation, 1200 New
Jersey Avenue SE., Washington, DC 20590-0001. Office hours are from
8:30 a.m. to 5 p.m., Monday through Friday, except Federal holidays.

SUPPLEMENTARY INFORMATION:

Background

    Under 49 U.S.C. 31315 and 31136(e), FMCSA may grant an exemption
for a 2-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 2-year period. The five
individuals listed in this notice have recently requested an exemption
from the epilepsy prohibition in 49 CFR 391.41(b)(8), which applies to
drivers who operate CMVs as defined in 49 CFR 390.5, in interstate
commerce. Section 391.41(b)(8) states that a person is physically
qualified to drive a commercial motor vehicle 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 commercial motor vehicle.
    FMCSA provides medical advisory criteria for use by medical
examiners in determining whether drivers with certain medical
conditions should be certified to operate commercial motor vehicles in
intrastate commerce. The advisory criteria indicates that if an
individual has had a sudden episode of a non-epileptic seizure or loss
of consciousness of unknown cause which did not require anti-seizure
medication, the decision whether that person's condition is likely to
cause the loss of consciousness or loss of ability to control a CMV
should be made on an individual basis by the medical examiner in
consultation with the treating physician. Before certification is
considered, it is suggested that a 6-month waiting period elapse from
the time of the episode. Following the waiting period, it is suggested
that the individual have a complete neurological examination. If the
results of the examination are negative and anti-seizure medication is
not required, then the driver may be qualified.
    In those individual cases where a driver had a seizure or an
episode of loss of consciousness that resulted from a known medical
condition (e.g., drug reaction, high temperature, acute infectious
disease, dehydration, or acute metabolic disturbance), certification
should be deferred until the driver has fully recovered from that
condition, has no existing residual complications, and is not taking
anti-seizure medication. Drivers with a history of epilepsy/seizures
off anti-seizure medication and seizure-free for 10 years may be
qualified to operate a CMV in interstate commerce. Interstate drivers
with a history of a single unprovoked seizure may be qualified to drive
a CMV in interstate commerce if seizure-free and off anti-seizure
medication for a 5-year period or more.

Summary of Applications

Todd Brock

    Mr. Brock is a 53-year-old driver in the state of Colorado. He
previously drove delivery trucks for UPS. He was diagnosed with a
seizure disorder and given anti-seizure medication. He continues to
take anti-seizure medication with the dosage and frequency remaining
the same for 3 years. Mr. Brock has been seizure-free for 9 years,
having his last seizure January 2003. If granted the exemption, he
would return to driving a delivery truck for UPS.

Darren Carroll

    Mr. Carroll is a 37-year-old CMV driver in the state of Virginia.
Mr. Carroll had a single seizure event in March 2008 following a blow
to the back of his head. He has never been on anti-seizure medication,
remaining seizure-free since the single seizure. His last seizure was
March 2008.

Charles Johnson

    Mr. Johnson is a 36-year-old CMV driver in the state of Kansas. Mr.
Johnson was diagnosed with petite mal

seizures as an infant. These seizures last only a few seconds, and he
has not had any grand mal seizures. His last seizure was in April 2011.
He has been on anti-seizure medication with the dosage and frequency
remaining the same for 4 months. If granted the exemption, he would
return to driving a school bus. His physician has released him to
return to driving.

Diana Mugford

    Ms. Mugford is a 44-year-old CDL driver in the state of Vermont.
She was diagnosed with complex partial seizures and given anti-seizure
medication. Her last seizure was in 2004. She continues to take anti-
seizure medication with the dosage and frequency remaining the same for
8 years. She has remained seizure-free for 8 years. If granted the
exemption, she would return to driving tractor trailer trucks in
interstate commerce. Her physician endorses her receiving an exemption
and states he feels ``she would be among the safer drivers on the
highway.''

James Wiggins

    Mr. Wiggins is a 57-year-old CMV driver in the state of Florida.
Mr. Wiggins had a single seizure in March 2008 and was diagnosed with a
brain tumor. He had the tumor removed in April 2008 and put on anti-
seizure medication. He has been off of any anti-seizure medication for
3 years and has remained seizure free for 4 years. If granted the
exemption, he would return to driving tractor trailer trucks.

Request for Comments

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

    Issued on: February 22, 2012.
 Larry W. Minor,
 Associate Administrator for Policy.
[FR Doc. 2012-4869 Filed 2-28-12; 8:45 am]
BILLING CODE P


Exchange, this position is not expressly in the Current Governing
Documents and now proposes to codify this position in the new Bylaws.
---------------------------------------------------------------------------

    \114\ The Chair of the Board would be an independent Director as
defined in Rule 5605 of the listing rules of The NASDAQ Stock
Market, LLC.
    \115\ See NSM Bylaw Article IV for substantially similar
provisions.
---------------------------------------------------------------------------

    Bylaw Article VII, titled ``Miscellaneous Provisions,'' contains
standard limited liability company provisions relating to waiver of
notice of meetings and the Exchange's contracting ability. Article
VIII, titled ``Amendments; Emergency By-Laws,'' authorizes amendments
to the By-Laws by either the Sole LLC Member or the vote of a majority
of the whole Board,\116\ as well as the adoption of emergency by-laws
by the Board. Other than as noted above, Articles VII and VIII mirror
the language in Articles VII and VIII of the NSM Bylaws.
---------------------------------------------------------------------------

    \116\ As proposed, all such changes must be filed with the
Commission under Section 19(b) of the Act, 15 U.S.C. 78s(b), and
become effective thereunder before being implemented. See proposed
Bylaw Article VIII, Section 1. The BX Bylaws and the NSM Bylaws do
not have a similar requirement, but Phlx has a similar requirement
in Section 6-9 of the Phlx Bylaws. BX and NSM will each separately
file proposed rule changes with the Commission to add this
requirement in their respective governing documents. See note 46
above.
---------------------------------------------------------------------------

    Article IX, titled ``Exchange Authorities,'' which mirrors NSM
Bylaw Article IX, contains specific authorization for the Board to
adopt rules needed to effect the Exchange's obligations as an SRO, to
establish disciplinary procedures and impose sanctions on its members,
to establish standards for membership, to impose dues, fees,
assessments, and other charges and to take action under emergency or
extraordinary market conditions.

D. Rules

    The Exchange proposes to amend its current Rules to reflect the
changes to its constituent documents through the adoption of the New
Governing Documents to replace the Current Governing Documents.\117\
All of the proposed changes are non-substantive, and primarily reflect
the changing terminology from ``Constitution'' to ``By-Laws,'' \118\ or
to remove references to the Current LLC Agreement \119\ as these will
become obsolete under the Proposed Rule Change. Furthermore, a number
of defined terms used in the Rules refer back to the Current LLC
Agreement or the Current Constitution for their meanings. As discussed
below, the Exchange proposes to add these defined terms originally
contained in the Current Governing Documents as new Rules. In addition,
a number of existing Rules contain references to the Current Governing
Documents, and the Exchange proposes to amend these provisions either
by (i) replacing those references with references to the New Governing
Documents or (ii) importing language originally found in the Current
Governing Documents, as further described below. Finally, the Exchange
proposes to make a number of technical amendments to renumber the
Rules, which is a result of adding the new definitions as further
discussed below.
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    \117\ The amended Rules were filed as part of the Proposed Rule
Change as Exhibit 5E.
    \118\ In particular, the proposed changes are in Rules 200, 202,
203, 305(a), 307(c), 307(d), and 711(a), as well as in
.01(b)(2)(iii) of Supplementary Material to Rule 706.
    \119\ In particular, the proposed changes are in Rules
100(a)(22A), 302(c), and 302(e).
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    In Rule 100, titled ``Definitions,'' the Exchange proposes to make
the following changes:
     Rule 100(a) currently refers to Article XIII of the
Current Constitution as containing certain defined terms that are also
used in the Exchange's rulebook. The proposed change would replace the
reference to Article XIII of the Current Constitution with references
to the proposed LLC Agreement and By-Laws.
     Rule 100(a)(5) ``board of directors'' or ``Board''
currently refers to Article I of the LLC Agreement. The proposed change
reflects that this definition will be set forth in Article I of the new
Bylaws.
     Rule 100(a)(12) ``CMM Rights'' currently refers to Article
VI of the Current LLC Agreement. The proposed change would relocate the
concept of CMM Rights from the Current LLC Agreement to this Rule, and
would state that the term CMM Rights means the non-transferable rights
held by a Competitive Market Maker.\120\
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    \120\ CMM Rights are non-transferable rights in that the holders
of CMM Rights may not lease or sell these rights. As discussed in
the LLC Agreement section above, all Exchange Rights (i.e., PMM, CMM
and EAM Rights) convey voting rights and trading privileges on the
Exchange. From GEMX's inception, the voting rights and trading
privileges associated with the PMM, CMM, and EAM Rights have never
been transferable. See GEMX Approval Order.
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     New Rule 100(a)(13) ``Competitive Market Maker'' would be
relocated from Section 13.1(f) of the Current Constitution. Currently,
this term is used throughout the Exchange's rulebook, but the
definition is only found in the Current Constitution.
     Rules 100(a)(13)-(14) ``covered short position'' and
``discretion,'' respectively, would be renumbered as Rules 100(a)(14)-
(15).
     Rule 100(a)(15) ``EAM Rights'' currently refers to Article
VI of the Current LLC Agreement. The proposed change would relocate the
concept of EAM Rights from the Current LLC Agreement to this Rule, and
would state that EAM Rights means the non-transferable rights held by
an Electronic Access Member.\121\ The Rule would also be renumbered as
Rule 100(a)(16).
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    \121\ See note 120 above.
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     New Rule 100(a)(17) ``Electronic Access Member'' would be
relocated from Section 13.1(j) of the Current Constitution. Currently,
this term is used throughout the Exchange's rulebook, but the
definition is only found in the Current Constitution.
     Rules 100(a)(16) and (17) ``European-style option,''
``Exchange Act'' and ``Exchange Rights,'' respectively, would be
renumbered as Rules 100(a)(18)-(20).\122\
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    \122\ ``European-style option'' and ``Exchange Act'' are both
inadvertently numbered as Rule 100(a)(16) in the current Rules, so
the proposed changes will renumber these Rules as Rules 100(a)(18)
and (19), respectively.
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     New Rule 100(a)(21) ``Exchange Transaction'' would be
relocated from Section 13.1(o) of the Current Constitution. Currently,
this term is used throughout the Exchange's

rulebook, but the definition is only found in the Current Constitution.
     Rules 100(a)(18) and (19) ``exercise price'' and ``Federal
Reserve Board,'' respectively, would be renumbered as Rules 100(a)(22)
and (23).
     New Rule 100(a)(24) ``good standing'' would be relocated
from Section 13.1(p) of the Current Constitution. Currently, this term
is used throughout the Exchange's rulebook, but the definition is only
found in the Current Constitution.
     Rules 100(a)(20)-(22) ``he,'' ``him'' or ``his,'' ``ISE,''
and ``long position,'' respectively, would be renumbered as Rules
100(a)(25)-(27).
     Rule 100(a)(22A) ``LLC Agreement'' would be deleted as
that term would no longer be used in the Rules, as amended by this rule
change.
     Rules 100(a)(23)-(35) ``Member,'' ``Membership,'' ``market
makers,'' ``Market Maker Rights,'' ``Non-Customer,'' ``Non-Customer
Order,'' ``offer,'' ``opening purchase transaction,'' ``opening writing
transaction,'' ``Voluntary Professional,'' ``options contract,''
``OPRA,'' ``order'' and ``outstanding,'' respectively, would be
renumbered as Rules 100(a)(28)-(40).
     Rule 100(a)(36) ``PMM Rights'' currently refers to Article
VI of the Current LLC Agreement. The proposed change would relocate the
concept of PMM Rights from the Current LLC Agreement to this Rule, and
would state that PMM Rights means the non-transferable rights held by a
Primary Market Maker.\123\ The Rule would also be renumbered as Rule
100(a)(41).
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    \123\ See note 120 above.
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     New Rule 100(a)(42) ``Primary Market Maker'' would be
relocated from Section 13.1(y) of the Current Constitution. Currently,
this term is used throughout the Exchange's rulebook, but the
definition is only found in the Current Constitution.
     Rules 100(a)(37), (37A), (37B), (37C), (38)-(48) ``primary
market,'' ``Priority Customer,'' ``Priority Customer Order,''
``Professional Order,'' ``Public Customer,'' ``Public Customer Order,''
``put,'' ``Quarterly Options Series,'' ``quote'' or ``quotation,''
``Rules of the Clearing Corporation,'' ``SEC,'' ``series of options,''
``short position,'' ``Short Term Option Series'' and ``SRO,''
respectively, would be renumbered as Rules 100(a)(43), (43A), (43B),
(43C), (44)-(54).
     New Rule 100(a)(55) ``System'' would be relocated from
Section 13.1(dd) of the Current Constitution. Currently, this term is
used throughout the Exchange's rulebook, but the definition is only
found in the Current Constitution.
     Rules 100(a)(49)-(51) ``type of option,'' ``uncovered''
and ``underlying security,'' respectively, would be renumbered as Rules
100(a)(56)-(58).
    In Rule 304(b), the Exchange is proposing to replace the references
to the Current Governing Documents with the proposed Bylaws to state
that no Exchange member shall exercise voting rights in excess of those
permitted under the Bylaws.\124\
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    \124\ See proposed Bylaw Article II, Section 2. An Exchange
Member, either alone or together with its affiliates, may not cast
votes representing more than 20% of the votes cast for a candidate.
A similar 20% voting limitation is also in Section 6.3(b) of the
Current LLC Agreement.
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    In Rule 309 ``Limitation on Affiliation between the Exchange and
Members,'' the Exchange proposes to replace references to ``Exchange
Director'' and ``Constitution'' with ``Member Representative Director''
and ``By-Laws,'' respectively, for the reasons discussed above. Lastly,
the proposed changes in Rule 713(a) and Rule 720(a)(1) reflect the
renumbering of the defined terms ``offer,'' ``quotations,'' ``Priority
Customer Orders,'' ``Professional Orders,'' and ``Priority Customer.''
2. Statutory Basis
    The Exchange believes that its proposal is consistent with Section
6(b) of the Act,\125\ in general, and furthers the objectives of
Section 6(b)(1) of the Act,\126\ in particular, in that it enables the
Exchange to be so organized as to have the capacity to be able to carry
out the purposes of the Act and to comply, and to enforce compliance by
its exchange members and persons associated with its exchange members,
with the provisions of the Act, the rules and regulations thereunder,
and the rules of the Exchange. The Exchange also believes that this
proposal furthers the objectives of Section 6(b)(3) and (b)(5) of the
Act \127\ in particular, in that it is designed to assure a fair
representation of Exchange members in the selection of its directors
and administration of its affairs and provide that one or more
directors would be representative of issuers and investors and not be
associated with a member of the exchange, broker, or dealer; and is
designed to promote just and equitable principles of trade, to remove
impediments to and perfect the mechanism of a free and open market and
a national market system, and, in general to protect investors and the
public interest.
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    \125\ 15 U.S.C. 78f(b).
    \126\ 15 U.S.C. 78f(b)(1).
    \127\ 15 U.S.C. 78f(b)(3) and (b)(5).
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    The Exchange believes that its proposal to adopt the Board and
committee structure and related nomination and election processes set
forth in New Governing Documents are consistent with the Act, including
Section 6(b)(1) of the Act, which requires, among other things, that a
national securities exchange be organized to carry out the purposes of
the Act and comply with the requirements of the Act. In general, the
proposed changes would make the Exchange's Board and committee
composition requirements, and related nomination and election
processes, more consistent with those of its affiliates, BX, NSM and
Phlx. The Exchange therefore believes that the proposed changes would
contribute to the orderly operation of the Exchange and would enable
the Exchange to be so organized as to have the capacity to carry out
the purposes of the Act and comply with the provisions of the Act by
its members and persons associated with members.
    Additionally, the Exchange believes that the New Governing
Documents support a corporate governance framework that is designed to
insulate the Exchange's regulatory functions from its market and other
commercial interests so that the Exchange can carry out its regulatory
obligations in furtherance of Section 6(b)(1) of the Act. Specifically,
the Exchange believes that creation of a ROC, modeled on the approved
ROCs of other Nasdaq Exchanges, and the inclusion of the Chief
Regulatory Officer in the proposed Bylaws, would underscore the
importance of the Exchange's regulatory function and specifically
empower an independent committee of the Board to oversee regulation and
meet regularly with the Chief Regulatory Officer. Furthermore, proposed
language in the New Governing Documents specifically providing that the
Exchange's business and the Board's evaluations would include actions
and evaluations that support and take into account its regulatory
responsibilities under the Act, reinforce the notion that the Exchange
is not solely a commercial enterprise, but an SRO subject to the
obligations imposed by the Act. The restriction on using Regulatory
Funds to pay dividends to the Sole LLC Member further underscores the
independence of the Exchange's regulatory function. Finally, the
Exchange believes that the proposed requirements to include Public
Directors on the Board (at least two Directors) and that on the ROC
(all three Directors) would help to ensure that no single group of
market

participants will have the ability to systematically disadvantage other
market participants through the exchange governance process, and would
foster the integrity of the Exchange by providing unique, unbiased
perspectives. Accordingly, the Exchange believes that the new board and
committee structure contemplated by the proposed New Governing
Documents is designed to insulate the Exchange's regulatory functions
from its market and other commercial interests so that the Exchange can
carry out its regulatory obligations in furtherance of Section 6(b)(1)
of the Act.
    The Exchange also believes that the proposed 20% requirement for
Member Representative Directors and the proposed method for selecting
Member Representative Directors would ensure fair representation of
Exchange members on the Board and allow members to have a voice in the
Exchange's use of its self-regulatory authority. In particular, the
Exchange notes that the Member Nominating Committee would be composed
solely of persons associated with Exchange members and is selected
after consultation with representatives of Exchange members. In
addition, the new Bylaws include a process by which Exchange members
can directly petition and vote for representation on the Board. For the
foregoing reasons, the Exchange believes that the proposed change to
remove the Exchange Director positions and related concepts from its
organizational documents is consistent with fair representation
requirement under the Act. Specifically, Exchange members will continue
to be represented on the Board and on key standing committees, and will
have a voice in the selection of Member Representative Directors
through the Member Nominating Committee and through their ability to
petition and vote on alternate candidates. As noted above, the trading
privileges associated with the Exchange Rights, which are currently
located in the Exchange's organizational documents, are already
substantively in the Exchange's rulebook, and the Rules would be
clarified to the extent such Rules refer back to the Current Governing
Documents.
    The Exchange also believes that the proposed Board and composition
requirements set forth in the New Governing Documents is consistent
with the requirements of Section 6(b)(3) of the Act, because the Public
Director positions on the Board and on the ROC would include the
representatives of issuers and investors with no material business
relationship with a broker dealer or the Exchange. Further, the
Exchange believes that the proposed compositional balance of the
proposed committees continues to provide for the fair representation of
members in the administration of the affairs of the Exchange. In
particular, all members of the new Member Nominating Committee must be
associated persons of an Exchange member. In addition, at least 20% of
the new QMC must be composed of Member Representative members.
Moreover, the proposed compositional requirements provide that the
Nominating Committee and the QMC must be compositionally balanced
between Industry members and Non-Industry members. The proposed
compositional requirements are designed to ensure that members are
protected from unfair, unfettered actions by an exchange pursuant to
its rules, and that, in general, an exchange is administered in a way
that is equitable to all those who trade on its market or through its
facilities.
    Moreover, the Exchange believes that the new corporate governance
framework and related processes proposed by the New Governing Documents
are consistent with Section 6(b)(5) of the Act because they are
identical to the framework and processes used by the Nasdaq Exchanges,
which have been well-established as fair and designed to protect
investors and the public interest. The Exchange believes that adopting
the New Governing Documents based on the NSM model would streamline the
Nasdaq Exchanges' governance process, create equivalent governing
standards among HoldCo's SROs and also provide clarity to its members,
which is beneficial to both investors and the public interest.
    Finally, the proposed amendments to the Rules as discussed above
are non-substantive changes to clarify the rule text where the Rule
referred only to the Current LLC Agreement or to the Current
Constitution, and also the technical amendments to renumber certain
Rules.

B. Self-Regulatory Organization's Statement on Burden on Competition

    Because the Proposed Rule Change relates to the corporate
governance of the Exchange and not to the operations of the Exchange,
the Exchange does not believe that the proposed rule change will impose
any burden on competition not necessary or appropriate in furtherance
of the purposes of the Act.

C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants, or Others

    No written comments were either solicited or received.

III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    Within 45 days of the date of publication of this notice in the
Federal Register or within such longer period (i) as the Commission may
designate up to 90 days of such date if it finds such longer period to
be appropriate and publishes its reasons for so finding or (ii) as to
which the Exchange consents, the Commission shall: (a) By order approve
or disapprove such proposed rule change, or (b) institute proceedings
to determine whether the proposed rule change should be disapproved.

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-GEMX-2017-37 on the subject line.

Paper Comments

     Send paper comments in triplicate to Brent J. Fields,
Secretary, Securities and Exchange Commission, 100 F Street NE.,
Washington, DC 20549-1090.

All submissions should refer to File Number SR-GEMX-2017-37. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and

printing in the Commission's Public Reference Room, 100 F Street NE.,
Washington, DC 20549, on official business days between the hours of
10:00 a.m. and 3:00 p.m. Copies of the filing also will be available
for inspection and copying at the principal office of the Exchange. All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File Number SR-GEMX-2017-37 and should be
submitted on or before September 13, 2017.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\128\
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    \128\ 17 CFR 200.30-3(a)(12).
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Eduardo A. Aleman,
Assistant Secretary.
[FR Doc. 2017-17810 Filed 8-22-17; 8:45 am]
BILLING CODE 8011-01-P