[Federal Register Volume 87, Number 33 (Thursday, February 17, 2022)]
[Notices]
[Pages 9064-9066]
[FR Doc No: 2022-03430]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-0410]

Peripheral and Central Nervous System Drugs Advisory Committee;
Notice of Meeting; Establishment of a Public Docket; Request for
Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; establishment of a public docket; request for comments.

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SUMMARY: The Food and Drug Administration (FDA) announces a forthcoming
public advisory committee meeting of the Peripheral and Central Nervous
System Drugs Advisory Committee. The general function of the committee
is to provide advice and recommendations to FDA on regulatory issues.
The meeting will be open to the public. FDA is establishing a docket
for public comment on this document.

DATES: The meeting will take place virtually on March 30, 2022, from 10
a.m. to 4:30 p.m. Eastern Time.

ADDRESSES: Please note that due to the impact of this COVID-19
pandemic, all meeting participants will be joining this advisory
committee meeting via an online teleconferencing platform. Answers to
commonly asked questions about FDA advisory committee meetings may be
accessed at: https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm.
    FDA is establishing a docket for public comment on this meeting.
The docket number is FDA-2018-N-0410. The docket will close on March
29, 2022. Submit either electronic or written comments on this public
meeting by March 29, 2022. Please note that late, untimely filed
comments will not be considered. Electronic comments must be submitted
on or before March 29, 2022. The https://www.regulations.gov electronic
filing system will accept comments until 11:59 p.m. Eastern Time at the
end of March 29, 2022. Comments received by mail/hand delivery/courier
(for written/paper submissions) will be considered timely if they are
postmarked or the delivery service acceptance receipt is on or before
that date.
    Comments received on or before March 16, 2022, will be provided to
the committee. Comments received after that date will be taken into
consideration by FDA. In the event that the meeting is cancelled, FDA
will continue to evaluate any relevant applications or information, and
consider any comments submitted to the docket, as appropriate.
    You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.

     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2018-N-0410 for ``Peripheral and Central Nervous System Drugs
Advisory Committee; Notice of Meeting; Establishment of a Public
Docket; Request for Comments.'' Received comments, those filed in a
timely manner (see ADDRESSES), will be placed in the docket and, except
for those submitted as ``Confidential Submissions,'' publicly viewable
at https://www.regulations.gov or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday through Friday,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' FDA will review
this copy, including the claimed confidential information, in its
consideration of comments. The second copy, which will have the claimed
confidential information redacted/blacked out, will be available for
public viewing and posted on https://www.regulations.gov. Submit both
copies to the Dockets Management Staff. If you do not wish your name
and contact information be made publicly available, you can provide
this information on the cover sheet and not in the body of your
comments and you must identify the information as ``confidential.'' Any
information marked as ``confidential'' will not be disclosed except in
accordance with 21 CFR 10.20 and other applicable disclosure law. For
more information about FDA's posting of comments to public dockets, see
80 FR 56469, September 18, 2015, or access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://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 Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Jessica Seo, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993-0002, 301-
796-7699, Fax:<PHONE_NUMBER>, email: [email protected], or FDA Advisory
Committee Information Line, 1-800-741-8138<PHONE_NUMBER> in the
Washington, DC area). 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 FDA's website at
https://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to
the appropriate advisory committee meeting link, or call the advisory
committee information line to learn about possible modifications before
coming to the meeting.

SUPPLEMENTARY INFORMATION:
    Agenda: The meeting presentations will be heard, viewed, captioned,
and recorded through an online teleconferencing platform. The committee
will discuss new drug application (NDA) 216660, for sodium
phenylbutyrate/taurursodiol (AMX0035) powder for oral suspension,
submitted by Amylyx Pharmaceuticals, Inc., for the treatment of
amyotrophic lateral sclerosis (ALS).
    FDA intends to make the meeting's background material and pre-
recorded presentations available to the public no later than 2 business
days before the meeting. The pre-recorded presentations will be viewed
by the committee prior to the meeting and will not be replayed on
meeting day. If FDA is unable to post the background material and/or
pre-recorded presentations on its website prior to the meeting, the
background material and/or pre-recorded presentations will be made
publicly available on FDA's website at the time of the advisory
committee meeting. The meeting will include brief summaries of the pre-
recorded presentations. The pre-recorded presentations and brief
summaries will include slide presentations with audio components to
allow the presentation of materials in a manner that most closely
resembles an in-person advisory committee meeting. Background material
and the link to the online teleconference meeting room will be
available at https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting
link.
    Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
All electronic and written submissions submitted to the Docket (see
ADDRESSES) on or before March 16, 2022, will be provided to the
committee. Oral presentations from the public will be scheduled between
approximately 1:30 p.m. and 2:30 p.m. Eastern Time. 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 March 8, 2022. 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 March 9, 2022.
    For press inquiries, please contact the Office of Media Affairs at
[email protected] or<PHONE_NUMBER>.
    FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
disabilities. If you require accommodations due to a disability, please
contact Jessica Seo (see FOR FURTHER INFORMATION CONTACT) at least 7
days in advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our website at https://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: February 14, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-03430 Filed 2-16-22; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 79, Number 160 (Tuesday, August 19, 2014)]
[Notices]
[Pages 49089-49091]
[FR Doc No: 2014-19577]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-D-0790]

Food and Drug Administration Decisions for Investigational Device
Exemption Clinical Investigations: Guidance for Sponsors, Clinical
Investigators, Institutional Review Boards, and Food and Drug
Administration Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of the guidance entitled ``FDA Decisions for
Investigational Device Exemption (IDE) Clinical Investigations.'' This
guidance document was developed to promote the initiation of clinical
investigations to evaluate medical devices under FDA's IDE regulations.
The guidance is intended to provide clarification regarding the
regulatory implications of the decisions that FDA may render based on
review of an IDE and to provide a general explanation of the reasons
for those decisions.

DATES: Submit either electronic or written comments on this guidance at
any time. General comments on Agency guidance documents are welcome at
any time.

ADDRESSES: An electronic copy of the guidance document is available for
download from the Internet. See the SUPPLEMENTARY INFORMATION section
for information on electronic access to the guidance. Submit written
requests for a single hard copy of the guidance document entitled ``FDA
Decisions for Investigational Device Exemption Clinical
Investigations'' to the Office of the Center Director, Guidance and
Policy Development, Center for Devices and Radiological Health, Food
and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431,
Silver Spring, MD 20993-0002; or the Office of Communication, Outreach
and Development, Center for Biologics Evaluation and Research, Food and
Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128,
Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to
assist that office in processing your request.
    Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852. Identify comments with the docket number
found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Owen Faris, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 1522, Silver Spring, MD 20993-0002,<PHONE_NUMBER>;
or Stephen Ripley, Center for Biologics Evaluation and Research, Food
and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301,
Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA seeks to encourage medical device research and innovation to
address important clinical needs and improve patient care. In many
cases, device development and evaluation include clinical
investigation. This guidance document has been developed to facilitate
the initiation of clinical investigations to evaluate medical devices
under FDA's IDE regulations, part 812 (21 CFR part 812).
    FDA approval of an IDE submission allows the initiation of subject
enrollment in a significant risk clinical investigation of a medical
device. This guidance is intended to provide clarification regarding
the regulatory implications of the decisions that FDA may render based
on review of an IDE and to provide a general explanation of the reasons
for those decisions.
    In an effort to promote timely initiation of subject enrollment in
clinical investigations in a manner that protects study subjects, FDA
has developed methods to allow a clinical investigation of a device to
begin under certain circumstances, even when outstanding issues
regarding the IDE submission remain. These mechanisms, including
Approval with Conditions, Staged Approval, and communication of
outstanding issues related to the IDE through Study Design
Considerations and Future Considerations, are described in this
guidance.
    FDA's decision-making process for IDEs was modified with passage of
the

Food and Drug Administration Safety and Innovation Act (FDASIA) (Pub.
L. 112-144). Section 601 of FDASIA amended section 520(g) of the
Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360j(g))
to specify certain situations in which FDA cannot disapprove an IDE.
Section 520(g)(4)(C) of the FD&C Act states that, consistent with
section 520(g)(1), FDA shall not disapprove an IDE because: (1) The
investigation may not support a substantial equivalence or de novo
classification determination or approval of the device; (2) the
investigation may not meet a requirement, including a data requirement,
relating to the approval or clearance of a device; or (3) an additional
or different investigation may be necessary to support clearance or
approval of the device. However, the Agency recognizes that some IDE
sponsors may wish to ensure that a pivotal study's design may support a
marketing application if it is successfully executed, meets its stated
endpoints, and does not raise unforeseen safety concerns. FDA is
interested in working interactively with sponsors to assist in
addressing important limitations with such a study that might impair
its ability to support a future marketing application.
    In the draft guidance, issued on June 14, 2013 (78 FR 35937), FDA
specifically sought public comment on three questions. Based on its
consideration of that feedback, the Agency has revised the guidance as
discussed further in this document.

A. Inclusion of Study Design Considerations in FDA's Decision Letters

    If FDA believes that modifications to the study design unrelated to
the safety, rights, or welfare of study subject are needed to enable a
sponsor to rely on the study as primary clinical support for a future
marketing approval or clearance, those modifications will be noted as
``study design considerations'' (SDCs). Sponsors are not required to
modify the investigational plan to address SDCs. However, if these
considerations are not addressed, the study design may not support the
study goals (e.g., a future marketing application). The draft guidance
proposed that SDCs be included in a section of the IDE decision letter.
    FDA received comments from several stakeholders proposing that FDA
provide SDCs and its assessment of the study design in a communication
separate from the decision letter. Other stakeholders expressed support
for inclusion of SDCs in the letter. Still others focused on ensuring
that the decision letter clearly conveys whether FDA believes the study
design is adequate to support its goals, even if the actual SDCs are
conveyed separately from the letter.
    Based on the comments received, FDA believes that sponsors and
other stakeholders may misinterpret SDCs included in the body of a
decision letter as issues that are required to be addressed. Therefore,
FDA intends to convey SDCs in a separate attachment included with the
decision letter, rather than in the body of the letter. The decision
letter itself will state whether FDA believes that the study design is
adequate to support the study goals or whether FDA recommends study
design considerations to enable it to do so. If FDA recommends SDCs,
FDA's letter will note the following: ``These recommendations do not
relate to the safety, rights or welfare of study subjects, and they do
not need to be addressed in order for you to conduct your study.'' FDA
will continue to engage with stakeholders on this issue and may make
modifications to this approach in the future.

B. Inclusion of Future Considerations in FDA's Decision Letters

    Future considerations are issues and recommendations that FDA
believes the sponsor should consider in preparing for a marketing
application or a future clinical investigation. Future considerations
are intended to provide helpful, non-binding advice to sponsors
regarding important elements of the future application that the IDE may
not specifically address. FDA sought comment on whether future
considerations should be communicated in its IDE decision letters or
whether they should be sent to the sponsor in a separate communication.
FDA received comments proposing that the Agency provide future
considerations as a separate communication and not in the decision
letter. Based on the comments received, FDA intends to convey future
considerations in a separate attachment included with the decision
letter rather than in the body of the letter.

C. Utility of the Proposed Pre-Decisional IDE Process

    The draft guidance proposed a new mechanism for review and
interaction for pivotal IDEs called the Pre-Decisional IDE. The process
included a comprehensive FDA review of a draft IDE prior to formal IDE
submission, followed by written feedback from FDA and an interactive
discussion between FDA and the sponsor. The goal of the Pre-Decisional
IDE was to facilitate the development of an improved IDE submission
more likely to be approved as well as a study design adequate to
support a future marketing application.
    FDA specifically sought comment on the expected utility of the Pre-
Decisional IDE process. Some commenters expressed support for the
proposal and felt that it might shorten the time to full approval of
pivotal IDE studies. Other commenters expressed concern that the Pre-
Decisional IDE process itself might be too time-consuming or require
extensive FDA resources that could be better allocated elsewhere. Based
on the comments received and FDA's consideration of the points raised,
FDA will not pursue the Pre-Decisional IDE at the present time.

II. Significance of Guidance

    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
Agency's current thinking on decisions for IDE clinical investigations.
It does not create or confer any rights for or on any person and does
not operate to bind FDA or the public. An alternative approach may be
used if such approach satisfies the requirements of the applicable
statute and regulations.

III. Electronic Access

    Persons interested in obtaining a copy of the guidance may do so by
downloading an electronic copy from the Internet. A search capability
for all Center for Devices and Radiological Health guidance documents
is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance
documents are also available at http://www.regulations.gov. or http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm. Persons
unable to download an electronic copy of ``Decisions for
Investigational Device Exemption Clinical Investigations,'' may send an
email request to<EMAIL_ADDRESS>to receive an electronic
copy of the document. Please use the document number 1783 to identify
the guidance you are requesting.

IV. Paperwork Reduction Act of 1995

    This guidance refers to previously 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 have been approved under OMB
control number 0910-0078.

V. Comments

    Interested persons may submit either electronic comments regarding
this document to http://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). It is only necessary to
send one set of 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, and will be posted to the docket at http://www.regulations.gov.

    Dated: August 13, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-19577 Filed 8-18-14; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 86, Number 105 (Thursday, June 3, 2021)]
[Notices]
[Pages 29876-29877]
[FR Doc No: 2021-11639]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-FMCSA-2021-0059]

Parts and Accessories Necessary for Safe Operation; Application
for an Exemption From Waste Management, Inc.

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

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

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SUMMARY: The Federal Motor Carrier Safety Administration (FMCSA)
requests public comment on Waste Management, Inc.'s (Waste Management)
application for an exemption to allow all of its 106 operating
companies to replace the high-mounted brake lights on their owned and
operated fleets of heavy-duty refuse and support trucks with red or
amber brake-activated pulsating lamps positioned in the upper center
position, or in an upper dual outboard position, in addition to the
steady burning brake lamps required by the Federal Motor Carrier Safety
Regulations (FMCSRs).

DATES: Comments must be received on or before July 6, 2021.

ADDRESSES: You may submit comments bearing the Federal Docket
Management System (FDMS) Docket ID FMCSA-2021-0059 using any of the
following methods:
     Website: http://www.regulations.gov. Follow the
instructions for submitting comments on the Federal electronic docket
site.
     Fax: 1-202-493-2251.
     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 by Courier: Bring comments to Docket
Operations in Room W12-140 of the West Building Ground Floor, U.S.
Department of Transportation, 1200 New Jersey Avenue SE, Washington,
DC, between 9 a.m. and 5 p.m. e.t., Monday-Friday, except Federal
holidays. To be sure someone is there to help you, please call (202)
366-9317 or<PHONE_NUMBER> before visiting Docket Operations.
    Instructions: All submissions must include the Agency name and
docket number for this notice. For detailed instructions on submitting
comments and additional information on the exemption process, see the
``Public Participation'' heading below. Note that all comments received
will be posted without change to http://www.regulations.gov, including
any personal information provided. Please see the ``Privacy Act''
heading for further information.
    Docket: For access to the docket to read background documents or
comments received, go to http://www.regulations.gov or to Docket
Operations in Room W12-140, U.S. Department of Transportation, West
Building Ground Floor, 1200 New Jersey Avenue SE, Washington, DC,
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. To be sure someone is there to help you, please call (202)
366-9317 or<PHONE_NUMBER> before visiting Docket Operations.
    Privacy Act: In accordance with 5 U.S.C. 553(c), DOT solicits
comments from the public to better inform its regulatory 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
www.dot.gov/privacy.
    Public participation: The http://www.regulations.gov website is
generally available 24 hours each day, 365 days each year. You may find
electronic submission and retrieval help and guidelines under the
``help'' section of the http://www.regulations.gov website as well as
the DOT's http://docketsinfo.dot.gov website. If you would like
notification that we received your comments, please include a self-
addressed, stamped envelope or postcard or print the acknowledgment
page that appears after submitting comments online.

FOR FURTHER INFORMATION CONTACT: Mr. Luke W. Loy, Vehicle and Roadside
Operations Division, Office of Carrier, Driver, and Vehicle Safety, MC-
PSV, Federal Motor Carrier Safety Administration, 1200 New Jersey
Avenue SE, Washington, DC 20590-0001,<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Public Participation and Request for Comments

    FMCSA encourages you to participate by submitting comments and
related materials.

Submitting Comments

    If you submit a comment, please include the docket number for this
notice (FMCSA-2021-0059), indicate the specific section of this
document to which the comment applies, and provide a reason for
suggestions or recommendations. 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 the Agency can contact you if it has questions
regarding your submission.
    To submit your comments online, go to https://www.regulations/documents/FMCSA-2021-0059, click ``Comment,'' and type your comment
into the text box in the following screen.
    If you submit your comments by mail or hand delivery, submit them
in an unbound format, no larger than 8\1/2\ by 11 inches, suitable for
copying and electronic filing. If you submit comments by mail and would
like to know that they reached the facility, please enclose a stamped,
self-addressed postcard or envelope. FMCSA will consider all comments
and material received during the comment period.

II. Legal Basis

    FMCSA has authority under 49 U.S.C. 31315(b) to grant exemptions
from certain parts of the Federal Motor Carrier Safety Regulations
(FMCSRs). FMCSA must publish a notice of each exemption request in the
Federal Register (49 CFR 381.315(a)). The Agency must provide the
public an opportunity to inspect the information relevant to the
application, including any safety analyses that have been conducted.
The Agency must also provide an opportunity for public comment on the
request. The Agency reviews the safety analyses and the public comments
and determines whether granting the exemption would likely achieve a
level of safety equivalent to or greater than the level that would be
achieved by the current regulation (49 CFR 381.305). The decision of
the Agency must be published in the Federal Register (49 CFR
381.315(b)). If the Agency denies the request, it must state the reason
for doing so. If the decision is to grant the exemption, the notice
must specify the person or class of persons receiving the exemption and
the regulatory provision or provisions from which an exemption is
granted. The notice must specify the effective period of the exemption
(up to 5 years) and explain the terms and conditions of the exemption.
The exemption may be renewed (49 CFR 381.315(c) and 49 CFR 381.300(b)).

III. Waste Management's Application for Exemption

    The FMCSRs require all exterior lamps (both required lamps and any
additional lamps) to be steady-burning, except for turn signal lamps,
hazard warning signal lamps, school bus warning lamps, amber warning
lamps or flashing warning lamps on tow trucks and commercial motor
vehicles transporting oversized loads, and warning lamps on emergency
and service vehicles authorized by State or local authorities. Waste
Management has applied for an exemption from 49 CFR 393.25(e) to allow
all of its 106 operating companies to replace the rear high-mounted
brake lights with red or amber brake-activated pulsating lamps
positioned in the upper center position, or in an upper dual outboard
position, in addition to the steady burning brake lamps required by the
FMCSRs. A copy of the exemption application is included in the docket
referenced at the beginning of this notice.

IV. Request for Comments

    In accordance with 49 U.S.C. 31315(b)(6), FMCSA requests public
comment from all interested persons on Waste Management's application
for an exemption from 49 CFR 393.25(e). All comments received before
the close of business on the comment closing date indicated at the
beginning of this notice will be considered and will be available for
examination in the docket at the location listed under the Addresses
section of this notice. Comments received after the comment closing
date will be filed in the public docket and will be considered to the
extent practicable. In addition to late comments, FMCSA will continue
to file, in the public docket, relevant information that becomes
available after the comment closing date. Interested persons should
continue to examine the public docket for new material.

Larry W. Minor,
Associate Administrator for Policy.
[FR Doc. 2021-11639 Filed 6-2-21; 8:45 am]
BILLING CODE 4910-EX-P


[Federal Register: November 16, 2006 (Volume 71, Number 221)]
[Notices]
[Page 66778]
[DOCID:fr16no06-71]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RP06-614-000]

Transwestern Pipeline Company, LLC; Notice of Technical
Conference

November 8, 2006.
    Take notice that the Commission will convene a technical conference
on Thursday November 30, 2006, at 10 a.m. (EST), in a room to be
designated at the offices of the Federal Energy Regulatory Commission,
888 First Street, NE., Washington DC 20426.
    The technical conference will deal with issues related to
Transwestern Pipeline Company, LLC's proposal to modify certain tariff
sheets in the General Terms and Conditions of its tariff and rate
schedules, as discussed in the October 31, 2006 order, Transwestern
Pipeline Company, LLC, 117 FERC ] 61,134.
    FERC conferences are accessible under section 508 of the
Rehabilitation Act of 1973. For accessibility accommodations please
send an e-mail to<EMAIL_ADDRESS>or call toll free (866) 208-
3372 (voice) or<PHONE_NUMBER> (TTY), or send a fax to<PHONE_NUMBER> with
the required accommodations.
    All interested persons are permitted to attend. For further
information please contact Russell Mamone at<PHONE_NUMBER> or e-mail
<EMAIL_ADDRESS>

Magalie R. Salas,
Secretary.
[FR Doc. E6-19332 Filed 11-15-06; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 88, Number 60 (Wednesday, March 29, 2023)]
[Proposed Rules]
[Pages 18496-18499]
[FR Doc No: 2023-06342]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R09-OAR-2023-0092; FRL-10674-01-R9]

Air Plan Revisions; California; Eastern Kern Air Pollution
Control District; Oxides of Nitrogen

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: The Environmental Protection Agency (EPA) is proposing a
limited approval and limited disapproval of a revision to the Eastern
Kern Air Pollution Control District (EKAPCD) portion of the California
State Implementation Plan (SIP). These revisions concern emissions of
oxides of nitrogen (NOX) from stationary gas turbines. We
are proposing action on a local rule that regulates these emissions
sources under the Clean Air Act (CAA). We are taking comments on this
proposal and plan to follow with a final action.

DATES: Comments must be received on or before April 28, 2023.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R09-
OAR-2023-0092 at https://www.regulations.gov. For comments submitted at
Regulations.gov, follow the online instructions for submitting
comments. Once submitted, comments cannot be edited or removed from
Regulations.gov. The EPA may publish any comment received to its public
docket. Do not submit electronically any information you consider to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Multimedia submissions (audio,
video, etc.) must be accompanied by a written comment. The written
comment is considered the official comment and should include
discussion of all points you wish to make. The EPA will generally not
consider comments or comment contents located outside of the primary
submission (i.e., on the web, cloud, or other file sharing system). For
additional submission methods, please contact the person identified in
the FOR FURTHER INFORMATION CONTACT section. For the full EPA public
comment policy, information about CBI or multimedia submissions, and
general guidance on making effective comments, please visit https://www.epa.gov/dockets/commenting-epa-dockets. If you need assistance in a
language other than English or if you are a person with disabilities
who needs a reasonable accommodation at no cost to you, please contact
the person identified in the FOR FURTHER INFORMATION CONTACT section.

FOR FURTHER INFORMATION CONTACT: La Kenya Evans-Hopper, EPA Region IX,
75 Hawthorne St., San Francisco, CA 94105. By phone:<PHONE_NUMBER> or
by email at [email protected].

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

Table of Contents

I. The State's Submittal
    A. What rule did the State submit?
    B. Are there other versions of this rule?
    C. What is the purpose of the submitted rule revision?
II. The EPA's Evaluation and Action
    A. How is the EPA evaluating the rule?
    B. Does the rule meet the evaluation criteria?
    C. What are the rule deficiencies?
    D. The EPA's Recommendations to Further Improve the Rule
    E. Public Comment and Proposed Action
III. Incorporation by Reference
IV. Statutory and Executive Order Reviews

I. The State's Submittal

A. What rule did the State submit?

    Table 1 lists the rule addressed by this proposal with the dates
that it was adopted by the local air agency and submitted by the
California Air Resources Board (CARB).

                                             Table 1--Submitted Rule
----------------------------------------------------------------------------------------------------------------
            Local agency                 Rule #               Rule title              Revised        Submitted
----------------------------------------------------------------------------------------------------------------
EKAPCD.............................             425  Stationary Gas Turbines            01/11/18        05/23/18
                                                      (Oxides of Nitrogen).
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    On November 15, 2018, the EPA determined that the submittal for
EKAPCD Rule 425 met the completeness criteria in 40 CFR part 51,
appendix V, which must be met before formal EPA review.

B. Are there other versions of this rule?

    We approved an earlier version of Rule 425 into the SIP on March 1,
1996 (61 FR 7992). The EKAPCD adopted revisions to the SIP-approved
version on January 11, 2018, and the CARB submitted them to us on May
23, 2018. If we take final action to approve the January 11, 2018
version of Rule 425, this version will replace the previously approved
version of this rule in the SIP.

C. What is the purpose of the submitted rule revision?

    Emissions of NOX contribute to the production of ground-
level ozone, smog and particulate matter (PM), which harm human health
and the environment. Section 110(a) of the CAA requires states to
submit regulations that control NOX emissions. Rule 425
establishes updated limits on NOX and carbon monoxide (CO)
for stationary gas turbine engines (units), equal to or greater than
0.88 megawatts (MW) operating in the EKAPCD. NOX emission
limits were set for stationary turbines, depending on their size, for
both gaseous and liquid fuel, with exemptions for smaller low-use
engines, emergency standby units, and additional categories described
in the technical support document (TSD). NOX emission limits
and work practice standards were also set for periods of startup and
shutdown. Monitoring requirements for continuous emissions monitoring
system (CEMS) control system operating parameters, providing source
testing for the exhaust gas NOX concentration, maintenance
of records for five years, and clarification on monitoring exhaust gas
NOX concentrations for units at 10 MW or greater were added.
Extra test methods for NOX and oxygen for compliance testing
and administrative requirements for exempt units have been added to the
rule. The EPA's TSD has more information about this rule.

II. The EPA's Evaluation and Action

A. How is the EPA evaluating the rule?

    Rules in the SIP must be enforceable (see CAA section 110(a)(2))
and must not interfere with applicable requirements concerning
attainment and reasonable further progress or other CAA requirements
(see CAA section 110(l)).
    Generally, SIP rules must require reasonably available control
technology (RACT) for each major source of NOX in ozone
nonattainment areas classified as Moderate or above (see CAA sections
182(b)(2) and 182(f)). The EKAPCD regulates an ozone nonattainment area
classified as Serious for the 2015 8-hour ozone National Ambient Air
Quality Standards (NAAQS), Severe for the 2008 8-hour ozone NAAQS and
Moderate for the 1997 8-hour ozone NAAQS. (40 CFR 81.305). Therefore,
this rule must implement RACT for major sources in the nonattainment
area.
    Guidance and policy documents that we used to evaluate
enforceability, revision/relaxation and rule stringency requirements
for the applicable criteria pollutants include the following:

    1. ``Issues Relating to VOC Regulation Cutpoints, Deficiencies,
and Deviations,'' EPA, May 25, 1988 (the Bluebook, revised January
11, 1990).
    2. ``Guidance Document for Correcting Common VOC & Other Rule
Deficiencies,'' EPA Region 9, August 21, 2001 (the Little Bluebook).
    3. ``State Implementation Plans: Response to Petition for
Rulemaking; Restatement and Update of EPA's SSM Policy Applicable to
SIPs; Findings of Substantial Inadequacy; and SIP Calls to Amend
Provisions Applying to Excess Emissions During Periods of Startup,
Shutdown and Malfunction,'' 80 FR 33839, June 12, 2015.
    4. ``NOX Emissions from Stationary Gas Turbines,''
EPA 453/R-93-007, January 1993.
    5. ``Determination of Reasonably Available Control Technology
and Best Available Retrofit Control Technology for the Control of
Oxides of Nitrogen from Stationary Gas Turbines,'' CARB, May 18,
1992.

B. Does the rule meet the evaluation criteria?

    Rule 425 improves the SIP by expanding the applicability threshold
of the rule to smaller units and non-cogeneration units, strengthening
requirements during startup and shutdown periods, and clarifying
monitoring, recording and recordkeeping provisions. The rule is largely
consistent with CAA requirements and relevant guidance regarding
enforceability, RACT, and SIP revisions. Rule provisions which do not
meet the evaluation criteria are summarized below and discussed further
in the TSD.

C. What are the rule deficiencies?

    The EPA is proposing to determine that the following provision does
not satisfy the requirements of section 110 and part D of title I of
the Act and prevents full approval of the SIP revision, for reasons
described here and explained in further detail in the TSD.
    1. Rule 425, section (V)(B) revised the NOX limits for
Westinghouse W251B10 turbines with Authority to Construct permits
issued before 1983 to 25 parts per million by volume. This revised
limit is higher than the limits for comparably sized units elsewhere in
the District, and higher than the limits applicable to such units in
the existing SIP- approved version of Rule 425. The submission has not
sufficiently justified why this higher limit meets the RACT
requirement. Moreover, the submission, which is seemingly a relaxation
of the rule, is not accompanied with a sufficient explanation as to why
the relaxation does not interfere with attainment of the NAAQS or
reasonable further progress. As a result, the submission has not shown
compliance with the requirement of CAA section 110(l).

D. The EPA's Recommendations to Further Improve the Rule

    The TSD includes recommendations for the next time local agency
modifies the rule.

E. Public Comment and Proposed Action

    As authorized in section 110(k)(3) of the Act, the EPA proposes a
limited approval of the submitted rule because it largely fulfills all
relevant requirements and strengthens the SIP. The EPA simultaneously
proposes a limited disapproval because of the

deficiency described in Section II.C of this document. We will accept
comments from the public on this proposal until April 28, 2023. If
finalized, this action would incorporate the submitted rule into the
SIP, including those provisions identified as deficient. This approval
is limited because the EPA is simultaneously proposing a limited
disapproval of the rule under section 110(k)(3).
    If we finalize this disapproval, CAA section 110(c) would require
the EPA to promulgate a federal implementation plan within 24 months
unless we approve a subsequent SIP revision that corrects the
deficiencies identified in our evaluation.
    In addition, final disapproval would trigger the offset sanction in
CAA section 179(b)(2) 18 months after the effective date of a final
disapproval, and the highway funding sanction in CAA section 179(b)(1)
six months after the offset sanction is imposed. A sanction will not be
imposed if the EPA determines that a subsequent SIP submission corrects
the deficiencies identified in our final action before the applicable
deadline.

III. Incorporation by Reference

    In this rule, the EPA is proposing to include in a final EPA rule
regulatory text that includes incorporation by reference. In accordance
with requirements of 1 CFR 51.5, the EPA is proposing to incorporate by
reference the EKAPCD Rule 425, Stationary Gas Turbines (Oxides of
Nitrogen), revised January 11, 2018, which regulates NOX and
CO for stationary gas turbine engines equal to or greater than 0.88 MW.
The EPA has made, and will continue to make, these materials available
through https://www.regulations.gov and at the EPA Region IX Office
(please contact the person identified in the FOR FURTHER INFORMATION
CONTACT section of this preamble for more information).

IV. Statutory and Executive Order Reviews

    Additional information about these statutes and Executive Orders
can be found at http://www.epa.gov/laws-regulations/laws-and-executive-orders.

A. Executive Order 12866: Regulatory Planning and Review and Executive
Order 13563: Improving Regulation and Regulatory Review

    This action is not a significant regulatory action and was
therefore not submitted to the Office of Management and Budget (OMB)
for review.

B. Paperwork Reduction Act (PRA)

    This action does not impose an information collection burden under
the PRA because this action does not impose additional requirements
beyond those imposed by state law.

C. Regulatory Flexibility Act (RFA)

    I certify that this action will not have a significant economic
impact on a substantial number of small entities under the RFA. This
action will not impose any requirements on small entities beyond those
imposed by state law.

D. Unfunded Mandates Reform Act (UMRA)

    This action does not contain any unfunded mandate as described in
UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect
small governments. This action does not impose additional requirements
beyond those imposed by state law. Accordingly, no additional costs to
state, local, or tribal governments, or to the private sector, will
result from this action.

E. Executive Order 13132: Federalism

    This action does not have federalism implications. It will not 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.

F. Executive Order 13175: Coordination With Indian Tribal Governments

    This action does not have tribal implications, as specified in
Executive Order 13175, because the SIP is not approved to apply on any
Indian reservation land or in any other area where the EPA or an Indian
tribe has demonstrated that a tribe has jurisdiction, and will not
impose substantial direct costs on tribal governments or preempt tribal
law. Thus, Executive Order 13175 does not apply to this action.

G. Executive Order 13045: Protection of Children From Environmental
Health Risks and Safety Risks

    The EPA interprets Executive Order 13045 as applying only to those
regulatory actions that concern environmental health or safety risks
that the EPA has reason to believe may disproportionately affect
children, per the definition of ``covered regulatory action'' in
section 2-202 of the Executive Order. This action is not subject to
Executive Order 13045 because it does not impose additional
requirements beyond those imposed by state law.

H. Executive Order 13211: Actions That Significantly Affect Energy
Supply, Distribution, or Use

    This action is not subject to Executive Order 13211, because it is
not a significant regulatory action under Executive Order 12866.

I. National Technology Transfer and Advancement Act (NTTAA)

    Section 12(d) of the NTTAA directs the EPA to use voluntary
consensus standards in its regulatory activities unless to do so would
be inconsistent with applicable law or otherwise impractical. The EPA
believes that this action is not subject to the requirements of section
12(d) of the NTTAA because application of those requirements would be
inconsistent with the CAA.

J. Executive Order 12898: Federal Actions To Address Environmental
Justice in Minority Populations and Low-Income Population

    Executive Order 12898 (Federal Actions To Address Environmental
Justice in Minority Populations and Low-Income Populations, 59 FR 7629,
Feb. 16, 1994) directs Federal agencies to identify and address
``disproportionately high and adverse human health or environmental
effects'' of their actions on minority populations and low-income
populations to the greatest extent practicable and permitted by law.
EPA defines environmental justice (EJ) as ``the fair treatment and
meaningful involvement of all people regardless of race, color,
national origin, or income with respect to the development,
implementation, and enforcement of environmental laws, regulations, and
policies.'' EPA further defines the term fair treatment to mean that
``no group of people should bear a disproportionate burden of
environmental harms and risks, including those resulting from the
negative environmental consequences of industrial, governmental, and
commercial operations or programs and policies.''
    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the Act and applicable
federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in
reviewing SIP submissions, the EPA's role is to review state choices,
and approve those choices if they meet the minimum criteria of the Act.
Accordingly, this proposed action limitedly approves and limitedly
disapproves state law as meeting federal requirements and does not
impose

additional requirements beyond those imposed by state law.
    The air agency did not evaluate environmental justice
considerations as part of its SIP submittal; the CAA and applicable
implementing regulations neither prohibit nor require such an
evaluation. EPA did not perform an EJ analysis and did not consider EJ
in this action. Due to the nature of the action being taken here, this
action is expected to have a neutral to positive impact on the air
quality of the affected area. Consideration of EJ is not required as
part of this action, and there is no information in the record
inconsistent with the stated goal of E.O. 12898 of achieving
environmental justice for people of color, low-income populations, and
Indigenous peoples.

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Carbon monoxide,
Incorporation by reference, Intergovernmental relations, Nitrogen
oxides, Ozone, Reporting and recordkeeping requirements.

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

    Dated: March 22, 2023.
Martha Guzman Aceves,
Regional Administrator, Region IX.
[FR Doc. 2023-06342 Filed 3-28-23; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register: July 14, 2008 (Volume 73, Number 135)]
[Notices]
[Page 40334]
[DOCID:fr14jy08-49]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

 [Docket No. ER08-1164-000]

Escanaba Paper Company; Supplemental Notice That Initial Market-
Based Rate Filing Includes Request for Blanket Section 204
Authorization

July 7, 2008.
    This is a supplemental notice in the above-referenced proceeding of
Escanaba Paper Company's application for market-based rate authority,
with an accompanying rate schedule, 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 Sec.
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 July 28, 2008.
    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-referenced proceeding 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>.

 Kimberly D. Bose,
 Secretary.
[FR Doc. E8-15881 Filed 7-11-08; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 82, Number 242 (Tuesday, December 19, 2017)]
[Notices]
[Pages 60237-60238]
[FR Doc No: 2017-27233]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-82314; File No. SR-Phlx-2017-100]

Self-Regulatory Organizations; Nasdaq PHLX LLC; Notice of Filing
and Immediate Effectiveness of Proposed Rule Change To Amend Chapter
VIII of the Phlx Pricing Schedule To Waive Port Fees for New PSX
Participants for a Limited Time

December 13, 2017.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'') \1\, and Rule 19b-4 thereunder,\2\ notice is hereby given
that on November 29, 2017, Nasdaq PHLX LLC (``Phlx'' or ``Exchange'')
filed with the Securities and Exchange Commission (``Commission'') the
proposed rule change as described in Items I, II, and III, below, which
Items have been prepared by the Exchange. The Commission is publishing
this notice to solicit comments on the proposed rule change from
interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to amend the Exchange's connectivity fees at
Chapter VIII of the Phlx Pricing Schedule to provide a waiver of all
connectivity fees to new PSX Participants for a limited time
    The text of the proposed rule change is available on the Exchange's
website at http://nasdaqphlx.cchwallstreet.com/, at the principal
office of the Exchange, and at the Commission's Public Reference Room.

II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, the Exchange included statements
concerning the purpose of and basis for the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. The Exchange has prepared summaries, set forth in
sections A, B, and C below, of the most significant aspects of such
statements.

A. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

1. Purpose
    The purpose of the proposed rule change is to amend the Exchange's
connectivity fees under ``Port Fees'' at Chapter VIII of the Nasdaq
PHLX LLC Pricing Schedule to provide a waiver of all such fees to new
PSX Participants for a limited time. Port fees include the choices for
connecting to PSX and receipt of data therefrom, together with the fees
assessed for that connectivity. Specifically, the Exchange is proposing
to waive all Port Fees for every Participant that is a ``new PSX
Participant'' through December 31, 2018. The Exchange is defining a
``new PSX Participant'' as a Participant that was not a Participant
before September 1, 2017. The Exchange believes that the proposed fee
waiver will make PSX a more attractive venue for prospective
Participants. The Exchange notes that its proposal is similar to one
that it implemented previously to attract new Participants.\3\
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    \3\ See Securities Exchange Act Release No. 34-78665 (Aug. 24,
2016), 81 FR 59693 (Aug. 30, 2016) (SR-Phlx-2016-85) (waiving port
fees through August 1, 2017 for those who were not Participants
after July 1, 2016).
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2. Statutory Basis

    The Exchange believes that its proposal is consistent with Section
6(b) of the Act,\4\ in general, and furthers the objectives of Sections
6(b)(4) and 6(b)(5) of the Act,\5\ in particular, in that it provides
for the equitable allocation of reasonable dues, fees and other charges
among members and issuers and other persons using any facility, and is
not designed to permit unfair discrimination between customers,
issuers, brokers, or dealers.
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    \4\ 15 U.S.C. 78f(b).
    \5\ 15 U.S.C. 78f(b)(4) and (5).
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    The Exchange believes that the proposed change is reasonable
because it will limit the overall costs incurred by new Participants in
connecting to the Exchange, which may as a consequence attract new
Participants. Attracting new Participants will benefit all market
participants on PSX by ensuring that PSX remains deep and liquid. The
Exchange believes that the proposed change is an equitable allocation
and is not unfairly discriminatory because the Exchange will uniformly
apply the same fee to all similarly situated Participants. In this
regard, the Exchange is proposing to apply the fee waiver to new PSX
Participants, which the Exchange proposes to define as a

Participant that was not a Participant prior to September 1, 2017.
    Limiting eligibility for the fee waiver, as described, will ensure
that the waiver is tailored to and effective in its purpose of
attracting new Participants. Waiving the fees for new Participants will
ease the burden of participating on PSX, which may be a significant
reason that such market participants have historically declined to
become Participants. Thus, to the extent this waiver is successful, the
proposed change will broaden participation on PSX, which will benefit
all Participants by providing more liquidity.

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

    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. In terms of inter-market
competition, the Exchange notes that it operates in a highly
competitive market in which market participants can readily favor
competing venues if they deem fee levels at a particular venue to be
excessive, or rebate opportunities available at other venues to be more
favorable. In such an environment, the Exchange must continually adjust
its fees to remain competitive with other exchanges and with
alternative trading systems that have been exempted from compliance
with the statutory standards applicable to exchanges. Because
competitors are free to modify their own fees in response, and because
market participants may readily adjust their order routing practices,
the Exchange believes that the degree to which fee changes in this
market may impose any burden on competition is extremely limited.
    In this instance, the proposed changes generally reduce the fee
burdens on Participants in an effort to attract and retain
Participants, which benefits all market participants on PSX to the
extent the incentives are effective.
    The Exchange notes that participation on PSX is completely
voluntary and subject to extensive competition both from other
exchanges and from off-exchange venues. Thus, to the extent that the
proposed changes to the connectivity fees proposed herein are
unattractive to market participants, it is likely that the Exchange
will lose market share and Participants as a result. Accordingly, the
Exchange does not believe that the proposed changes will impair the
ability of members or competing order execution venues to maintain
their competitive standing in the financial markets.

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

    The foregoing rule change has become effective pursuant to Section
19(b)(3)(A)(ii) of the Act.\6\
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    \6\ 15 U.S.C. 78s(b)(3)(A)(ii).
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    At any time within 60 days of the filing of the proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is: (i)
Necessary or appropriate in the public interest; (ii) for the
protection of investors; or (iii) otherwise in furtherance of the
purposes of the Act. If the Commission takes such action, the
Commission shall institute proceedings to determine whether the
proposed rule should be approved or 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 protected]. Please include
File Number SR-Phlx-2017-100 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-Phlx-2017-100. 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 website (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 website 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. Persons submitting comments are
cautioned that we do not redact or edit personal identifying
information from comment submissions. You should submit only
information that you wish to make available publicly. All submissions
should refer to File Number SR-Phlx-2017-100 and should be submitted on
or before January 9, 2018.
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    \7\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\7\
Eduardo A. Aleman,
Assistant Secretary.
[FR Doc. 2017-27233 Filed 12-18-17; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 85, Number 171 (Wednesday, September 2, 2020)]
[Rules and Regulations]
[Pages 54499-54501]
[FR Doc No: 2020-18196]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket Number USCG-2020-0447]
RIN 1625-AA00

Safety Zone; Beals Island Bridge Demolition, Moosabec Reach,
Jonesport, ME

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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SUMMARY: The Coast Guard is establishing a temporary safety zone on the
navigable waters of Moosabec Reach, ME within a 500-yard radius of the
Beals Island Bridge between Jonesport, ME and Beals Island, ME. The
Safety Zone is needed to protect personnel, vessels, and the marine
environment from the potential hazards created by underwater explosives
demolition of the Beals Island Bridge. This Safety Zone prohibits
persons and vessels from being in the safety zones unless authorized by
Sector Northern New England COTP or their Designated Representative.

DATES: This rule is effective without actual notice from September 2,
2020 through 31 October 2020. For the purposes of enforcement, actual
notice will be used from 17 August 2020 through September 2, 2020.

ADDRESSES: To view documents mentioned in this preamble as being
available in the docket, go to https://www.regulations.gov, type USCG-
2020-0447 in the ``SEARCH'' box and click ``SEARCH.'' Click on Open
Docket Folder on the line associated with this rule.

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or email Chief Marine Science Technician Thomas Watts, Sector
Northern New England Waterways Management Division, U.S. Coast Guard;
telephone<PHONE_NUMBER>, email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

CFR Code of Federal Regulations
DHS Department of Homeland Security
FR Federal Register
NPRM Notice of proposed rulemaking
Sec.  Section
U.S.C. United States Code
COTP Captain of the Port
RNA Regulated Navigation Area
TFR Temporary Final Rule

II. Background Information and Regulatory History

    On June 27, 2017, the U.S. Coast Guard District One Bridge Branch
issued a permit approving the construction of the Beals Island Bridge
across the Moosabec Reach in Jonesport, Maine. On September 11, 2017,
the contractor selected for the project submitted their request to the
Waterways Management Division of U.S. Coast Guard Sector Northern New
England. The COTP Sector Northern New England determined that an RNA
would be required to enforce speed, wake, and beam restrictions, as
well as provide for intermittent closure of the waterway during the
construction of the replacement bridge and subsequent demolition of the
original structure. On October 24, 2017, the Coast Guard published a
TFR entitled ``Regulated Navigation Area; Beals Island Bridge
Replacement, Moosabec Reach, Jonesport, ME'' in the Federal Register
(82 FR 49106) that would allow the Coast Guard to enforce speed and
wake restrictions and prohibit vessel traffic through the RNA during
bridge replacement operations on the Beals Island Bridge that could
pose an imminent hazard to persons and vessels operating in the area.
This rule would allow the Coast Guard to enforce additional navigation
restrictions and prohibit vessel traffic during drilling, blasting, and
dredging operations in support of the bridge replacement project.
    In June 2020 the project manager for the Beals Island Bridge
notified Coast Guard that the demolition plan had been revised to
include underwater explosive demolition of the old Beals Island Bridge.
The contractor requested the Coast Guard create a safety zone to
prohibit vessels and persons within a 250-foot radius of the old bridge
and

any vessel movement within 500-yards during each blasting event in
accordance with 29 CFR 1926.912. During this approximate 60-minute
window, no vessels or persons will be authorized within the safety zone
unless authorized by the Sector Northern New England COTP or Designated
Representative.
    The Coast Guard is issuing this temporary rule without prior notice
and opportunity to comment pursuant to authority under section 4(a) of
the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This
provision authorizes an agency to issue a rule without prior notice and
opportunity to comment when the agency for good cause finds that those
procedures are ``impracticable, unnecessary, or contrary to the public
interest.'' Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good
cause exists for not publishing a notice of proposed rulemaking (NPRM)
with respect to this rule because the schedule for the demolition of
old Beals Island Bridge was only recently finalized and timely action
is needed to respond to the potential safety hazards associated with
this demolition project. It is impracticable and contrary to the public
interest to publish an NPRM in order to establish this safety zone by
17 August 2020 to allow for the timely demolition of old Beals Island
Bridge and promote the safety of the public.

III. Legal Authority and Need for Rule

    The Coast Guard is issuing this rule under authority in 46 U.S.C.
70034. The COTP has determined that potential hazards associated with
underwater explosives demolition will be a safety concern for anyone
within a 500-yard radius of the old Beals Island Bridge. This rule is
needed to protect personnel, vessels, and the marine environment in the
navigable waters within the safety zone during underwater explosives
demolition of the old Beals Island Bridge.

IV. Discussion of the Rule

    This rule establishes a safety zone from 08:00 a.m. August 17, 2020
through 11:59 p.m. October 31, 2020. Currently there are six blast
events requiring closures lasting approximately one hour each. The zone
will only be enforced during the periods of demolition. Notification of
enforcement and blasting will be made with as much advanced notice as
possible with no less than 48 hours. The safety zone covers all
navigable waters of the Moosabec Reach, within approximately 500 yards
of any portion of the old Beals Island Bridge approximate position
44[deg]31'28'' N, 067[deg]36'53'' W (NAD 83). Although we expect the
blasting to be completed by October 11, 2020, we are publishing this
rulemaking to be effective, and enforceable, through October 31, 2020
in case the project is delayed due to unforeseen circumstances.
    The duration of the zone is intended to protect personnel, vessels,
and the marine environment in these navigable waters while the old
Beals Island Bridge is demolished for eventual removal. No vessel or
person will be permitted to enter the safety zone without obtaining
permission from the Sector Northern New England COTP or designated
representative.
    The Coast Guard will notify the public and local mariners of this
safety zone through the Local Notice to Mariners and/or Broadcast
Notice to Mariners via VHF-FM marine channel 16 in advance of any
scheduled enforcement period.

V. Regulatory Analyses

    We developed this rule after considering numerous statutes and
Executive orders related to rulemaking. Below we summarize our analyses
based on a number of these statutes and Executive orders, and we
discuss First Amendment rights of protestors.

A. Regulatory Planning and Review

    Executive Orders 12866 and 13563 direct agencies to assess the
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits. Executive Order 13771 directs agencies to control
regulatory costs through a budgeting process. This rule has not been
designated a ``significant regulatory action,'' under Executive Order
12866. Accordingly, this rule has not been reviewed by the Office of
Management and Budget (OMB), and pursuant to OMB guidance it is exempt
from the requirements of Executive Order 13771.
    This regulatory action determination is based on the size,
location, time of day, and the duration of enforcement of the safety
zone. Although vessel traffic will not be able to safely transit around
this safety zone when enforced, the zone will only be enforced during
the blasting events. As a result, enforcement of the safety zone will
be limited in duration, likely only one hour during each of the six
events. Additionally, the Coast Guard will issue Broadcast Notice to
Mariners via VHF-FM marine channel 16 about the zone and the rule
allows vessels to seek permission to enter the zone.

B. Impact on Small Entities

    The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as
amended, requires Federal agencies to consider the potential impact of
regulations on small entities during rulemaking. The term ``small
entities'' comprises small businesses, not-for-profit organizations
that are independently owned and operated and are not dominant in their
fields, and governmental jurisdictions with populations of less than
50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule
will not have a significant economic impact on a substantial number of
small entities.
    While some owners or operators of vessels intending to transit the
safety zone may be small entities, for the reasons stated in section
V.A above, this rule will not have a significant economic impact on any
vessel owner or operator.
    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this rule. If the rule would affect your
small business, organization, or governmental jurisdiction and you have
questions concerning its provisions or options for compliance, please
call or email the person listed in the FOR FURTHER INFORMATION CONTACT
section.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). The Coast Guard will not retaliate against small
entities that question or complain about this rule or any policy or
action of the Coast Guard.

C. Collection of Information

    This rule will not call for a new collection of information under
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

D. Federalism and Indian Tribal Governments

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect 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. We
have analyzed this rule under that Order and have determined that it is
consistent with the fundamental federalism principles and preemption
requirements described in Executive Order 13132.
    Also, this rule does not have tribal implications under Executive
Order 13175, Consultation and Coordination with Indian Tribal
Governments, because it does not have a substantial direct effect on
one or more Indian tribes, on the relationship between the Federal
Government and Indian tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian tribes.

E. Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or tribal government, in
the aggregate, or by the private sector of $100,000,000 (adjusted for
inflation) or more in any one year. Though this rule will not result in
such an expenditure, we do discuss the effects of this rule elsewhere
in this preamble.

F. Environment

    We have analyzed this rule under Department of Homeland Security
Directive 023-01, Rev. 1, associated implementing instructions, and
Environmental Planning COMDTINST 5090.1 (series), which guide the Coast
Guard in complying with the National Environmental Policy Act of 1969
(42 U.S.C. 4321-4370f), and have determined that this action is one of
a category of actions that do not individually or cumulatively have a
significant effect on the human environment. This rule involves a
safety zone lasting approximately 60 minutes during six separate
blasting events that will prohibit entry within 500-yards of the old
Beals Island Bridge. It is categorically excluded from further review
under paragraph L60(a) of Appendix A, Table 1 of DHS Instruction Manual
023-01-001-01, Rev. 1. A Record of Environmental Consideration
supporting this determination is available in the docket. For
instructions on locating the docket, see the ADDRESSES section of this
preamble.

G. Protest Activities

    The Coast Guard respects the First Amendment rights of protesters.
Protesters are asked to call or email the person listed in the FOR
FURTHER INFORMATION CONTACT section to coordinate protest activities so
that your message can be received without jeopardizing the safety or
security of people, places or vessels.

List of Subjects in 33 CFR Part 165

    Harbors, Marine safety, Navigation (water) Reporting and
recordkeeping requirements, Security measures, Waterways.
    For the reasons discussed in the preamble, the Coast Guard amends
33 CFR part 165 as follows:

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

0
1. The authority citation for part 165 continues to read as follows:

    Authority:  46 U.S.C. 70034, 70051; 33 CFR 1.05-1, 6.04-1, 6.04-
6, and 160.5; Department of Homeland Security Delegation No. 0170.1.

0
2. Add Sec.  165.T01-0447 to read as follows:

Sec.  165.T01-0447  Safety Zone; Beals Island Bridge Demolition,
Moosabec Reach, Jonesport, ME.

    (a) Location. The following area is a safety zone: All waters from
surface to bottom of Moosabec Reach within 500-yards of the old Beals
Island Bridge, at approximate position 44[deg]31'28'' N,
067[deg]36'53'' W (NAD 83).
    (b) Definitions. The following definitions apply to this section:
    (1) Designated Representative. A ``Designated Representative'' is
any Coast Guard Commissioned, Warrant or Petty Officer who has been
designated by the Captain of the Port, Sector Northern New England
(COTP), to act on his or her behalf. The Designated Representative may
be on an official patrol vessel or may be on shore and will communicate
with vessels via VHF-FM radio or loudhailer. In addition, members of
the Coast Guard Auxiliary may be present to inform vessel operators of
this regulation.
    (2) Official patrol vessels. Official patrol vessels may consist of
any Coast Guard, Coast Guard Auxiliary, state, or local law enforcement
vessels assigned or approved by the COTP.
    (c) Enforcement Periods. (1) This safety zone is effective from
August 17, 2020 to October 31, 2020 but will only be enforced when
bridge blasting operations are in progress.
    (2) The Coast Guard will utilize marine broadcasts and local notice
to mariners to notify the public of the time and duration that the
safety zone will be enforced. Violations of this safety zone may be
reported to the COTP or the Designated Representative via VHF channel
16 or<PHONE_NUMBER> (Coast Guard Sector Northern New England Command
Center).
    (d) Regulations. (1) The general regulations contained in 33 CFR
165.23, as well as the following regulations, apply.
    (2) No person or vessel is allowed within the safety zones unless
authorized by the cognizant Captain of the Port or their Designated
Representative.
    (3) During periods of enforcement, all persons and vessels must
comply with all orders and directions from the COTP or a COTP's
designated representative.
    (4) During periods of enforcement, upon being hailed by a U.S.
Coast Guard vessel by siren, radio, flashing light, or other means, the
operator of the vessel must proceed as directed.

    Dated: August 13, 2020.
B.J. LeFebvre,
Captain, U.S. Coast Guard, Captain of the Port, Sector Northern New
England.
[FR Doc. 2020-18196 Filed 9-1-20; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 82, Number 189 (Monday, October 2, 2017)]
[Rules and Regulations]
[Pages 45703-45705]
[FR Doc No: 2017-20824]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2017-0518; Product Identifier 2016-NM-167-AD; Amendment
39-19064; AD 2017-20-07]
RIN 2120-AA64

Airworthiness Directives; Bombardier, Inc., Airplanes

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

ACTION: Final rule.

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

SUMMARY: We are adopting a new airworthiness directive (AD) for certain
Bombardier, Inc., Model DHC-8-400 series airplanes. This AD was
prompted by the failure of the fire control amplifier (FCA), which was
likely caused by an electrical short in a discharged squib for a fire
extinguishing bottle. This AD requires replacing certain circuit
breakers. We are issuing this AD to address the unsafe condition on
these products.

DATES: This AD is effective November 6, 2017.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in this AD as of November 6,
2017.

ADDRESSES: For service information identified in this final rule,
contact Bombardier, Inc., Q-Series Technical Help Desk, 123 Garratt
Boulevard, Toronto, Ontario M3K 1Y5, Canada; telephone<PHONE_NUMBER>;
fax<PHONE_NUMBER>; email<EMAIL_ADDRESS>Internet
http://www.bombardier.com. You may view this referenced service
information at the FAA, Transport Standards Branch, 1601 Lind Avenue
SW., Renton, WA. For information on the availability of this material
at the FAA, call<PHONE_NUMBER>. It is also available on the Internet at
http://www.regulations.gov by searching for and locating Docket No.
FAA-2017-0518.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2017-
0518; or in person at the Docket Management Facility between 9 a.m. and
5 p.m., Monday through Friday, except Federal holidays. The AD docket
contains this AD, the regulatory evaluation, any comments received, and
other information. The street address for the Docket Office (telephone
800-647-5527) is Docket Management Facility, U.S. Department of
Transportation, Docket Operations, M-30, West Building Ground Floor,
Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT: Assata Dessaline, Aerospace Engineer,
Avionics and Administrative Services Section, FAA, New York ACO Branch,
1600 Stewart Avenue, Suite 410, Westbury, NY 11590; telephone 516-228-
7301; fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR
part 39 by adding an AD that would apply to certain Bombardier, Inc.,
Model DHC-8-400 series airplanes. The NPRM published in the Federal
Register on June 2, 2017 (82 FR 25554) (``the NPRM''). The NPRM was
prompted by the failure of the FCA, which was likely

caused by an electrical short in a discharged squib for a fire
extinguishing bottle. The NPRM proposed to require replacing certain
circuit breakers. We are issuing this AD to prevent failure of the FCA
and subsequent discharge of fire extinguishing bottles and false fire
indications, leaving the flight crew with reduced firefighting
capability in the event of a fire.
    Transport Canada Civil Aviation (TCCA), which is the aviation
authority for Canada, has issued Canadian Airworthiness Directive CF-
2016-25, dated August 22, 2016 (referred to after this as the Mandatory
Continuing Airworthiness Information, or ``the MCAI''), to correct an
unsafe condition for certain Bombardier, Inc., Model DHC-8-400 series
airplanes. The MCAI states:

    An operator reported having a false SMOKE warning light for the
Aft Baggage compartment, which caused the pilots to discharge the
Aft Baggage compartment fire extinguishing bottles per Aircraft
Flight Manual procedures. Subsequently, there were continuous engine
and Auxiliary Power Unit (APU) fire warning lights, and the fire
extinguishing bottles for both engines (forward and aft) and the APU
were automatically discharged. Post event investigation of the Fire
Control Amplifier (FCA) revealed a burnt 2600-P2 connector. The FCA
was also found to have sustained significant thermal damage. In a
separate event involving a different operator, several fire
extinguishing bottles discharged after an electrical short was
introduced into the FCA by a shorted squib tester (external ground
support equipment) during maintenance.
    The FCA manufacturer has identified the most likely failure
condition to be an electrical short at the discharged squib. The
squib's burst disk may have caused a short circuit of the
bridgewires, which caused the FCA's internal power wires to
experience thermal damage, consequently powering other squibs and
fire alarm lines and resulting in the uncommanded discharge of the
fire extinguishing bottles and false fire indications.
    Bombardier (BA) has issued service bulletin (SB) 84-26-16 to
change two 7.5 amp circuit breakers to lower current rating 1 amp
circuit breakers to prevent damage to squib discharge circuits and
the inadvertent discharge of fire extinguishing bottles.
    This [Canadian] AD mandates the incorporation of [Bombardier] SB
84-26-16 to prevent the inadvertent discharge of fire extinguishing
bottles [leaving the flight crew with reduced firefighting
capability in the event of a fire].

    You may examine the MCAI in the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2017-
0518.

Comments

    We gave the public the opportunity to participate in developing
this AD. We received no comments on the NPRM or on the determination of
the cost to the public.

Conclusion

    We reviewed the relevant data and determined that air safety and
the public interest require adopting this AD as proposed except for
minor editorial changes. We have determined that these minor changes:
     Are consistent with the intent that was proposed in the
NPRM for correcting the unsafe condition; and
     Do not add any additional burden upon the public than was
already proposed in the NPRM.

Related Service Information Under 1 CFR Part 51

    Bombardier, Inc., has issued Service Bulletin 84-26-16, Revision A,
dated February 12, 2016. This service information describes procedures
for locating and replacing certain 7.5-amp circuit breakers with 1-amp
circuit breakers. This service information is reasonably available
because the interested parties have access to it through their normal
course of business or by the means identified in the ADDRESSES section.

Costs of Compliance

    We estimate that this AD affects 53 airplanes of U.S. registry.
    We estimate the following costs to comply with this AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per      Cost on U.S.
                Action                         Labor cost           Parts cost        product        operators
----------------------------------------------------------------------------------------------------------------
Replacement of circuit breakers.......  3 work-hours x $85 per                $0            $255         $13,515
                                         hour = $255.
----------------------------------------------------------------------------------------------------------------

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. ``Subtitle VII: Aviation
Programs,'' describes in more detail the scope of the Agency's
authority.
    We are issuing this rulemaking under the authority described in
``Subtitle VII, Part A, Subpart III, Section 44701: General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.
    This AD is issued in accordance with authority delegated by the
Executive Director, Aircraft Certification Service, as authorized by
FAA Order 8000.51C. In accordance with that order, issuance of ADs is
normally a function of the Compliance and Airworthiness Division, but
during this transition period, the Executive Director has delegated the
authority to issue ADs applicable to transport category airplanes to
the Director of the System Oversight Division.

Regulatory Findings

    We determined that this AD will not have federalism implications
under Executive Order 13132. This AD will not have a substantial direct
effect 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.
    For the reasons discussed above, I certify that this AD:
    1. Is not a ``significant regulatory action'' under Executive Order
12866;
    2. Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979);
    3. Will not affect intrastate aviation in Alaska; and
    4. Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

Adoption of the Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA amends 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

    Authority: 49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new airworthiness
directive (AD):

2017-20-07 Bombardier, Inc.: Amendment 39-19064; Docket No. FAA-
2017-0518; Product Identifier 2016-NM-167-AD.

(a) Effective Date

    This AD is effective November 6, 2017.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to Bombardier, Inc., Model DHC-8-400, -401, and
-402 airplanes, certificated in any category, serial numbers 4001,
and 4003 through 4504 inclusive.

(d) Subject

    Air Transport Association (ATA) of America Code 26, Fire
protection.

(e) Reason

    This AD was prompted by the failure of the fire control
amplifier (FCA), which was likely caused by an electrical short in a
discharged squib for a fire extinguishing bottle. We are issuing
this AD to prevent failure of the FCA and subsequent discharge of
fire extinguishing bottles and false fire indications, leaving the
flight crew with reduced firefighting capability in the event of a
fire.

(f) Compliance

    Comply with this AD within the compliance times specified,
unless already done.

(g) Replacement of Affected Circuit Breakers

    Within 6,000 flight hours or 3 years, whichever occurs first,
after the effective date of this AD: Replace the 7.5-amp circuit
breakers specified in Bombardier Service Bulletin 84-26-16, Revision
A, dated February 12, 2016, with 1-amp circuit breakers having part
number MS3320-1, in accordance with the Accomplishment Instructions
of Bombardier Service Bulletin 84-26-16, Revision A, dated February
12, 2016.

(h) Credit for Previous Actions

    This paragraph provides credit for actions required by paragraph
(g) of this AD, if those actions were performed before the effective
date of this AD using Bombardier Service Bulletin 84-26-16, dated
August 14, 2015.

(i) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager, New
York ACO Branch, FAA, has the authority to approve AMOCs for this
AD, if requested using the procedures found in 14 CFR 39.19. In
accordance with 14 CFR 39.19, send your request to your principal
inspector or local Flight Standards District Office, as appropriate.
If sending information directly to the manager of the certification
office, send it to ATTN: Program Manager, Continuing Operational
Safety, FAA, New York ACO Branch, 1600 Stewart Avenue, Suite 410,
Westbury, NY 11590; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>. Before
using any approved AMOC, notify your appropriate principal
inspector, or lacking a principal inspector, the manager of the
local flight standards district office/certificate holding district
office.
    (2) Contacting the Manufacturer: For any requirement in this AD
to obtain corrective actions from a manufacturer, the action must be
accomplished using a method approved by the Manager, New York ACO
Branch, FAA; or Transport Canada Civil Aviation (TCCA); or
Bombardier, Inc.'s TCCA Design Approval Organization (DAO). If
approved by the DAO, the approval must include the DAO-authorized
signature.

(j) Related Information

    (1) Refer to Mandatory Continuing Airworthiness Information
(MCAI) Canadian Airworthiness Directive CF-2016-25, dated August 22,
2016, for related information. This MCAI may be found in the AD
docket on the Internet at http://www.regulations.gov by searching
for and locating Docket No. FAA-2017-0518.
    (2) For more information about this AD, contact Assata
Dessaline, Aerospace Engineer, Avionics and Administrative Services
Section, FAA, New York ACO Branch, 1600 Stewart Avenue, Suite 410,
Westbury, NY 11590; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>.
    (3) Service information identified in this AD that is not
incorporated by reference is available at the addresses specified in
paragraphs (k)(3) and (k)(4) of this AD.

(k) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference (IBR) of the service information listed
in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless this AD specifies otherwise.
    (i) Bombardier Service Bulletin 84-26-16, Revision A, dated
February 12, 2016.
    (ii) Reserved.
    (3) For service information identified in this AD, contact
Bombardier, Inc., Q-Series Technical Help Desk, 123 Garratt
Boulevard, Toronto, Ontario M3K 1Y5, Canada; telephone<PHONE_NUMBER>;
fax<PHONE_NUMBER>; email<EMAIL_ADDRESS>Internet
http://www.bombardier.com.
    (4) You may view this service information at the FAA, Transport
Standards Branch, 1601 Lind Avenue SW., Renton, WA. For information
on the availability of this material at the FAA, call<PHONE_NUMBER>.
    (5) You may view this service information that is incorporated
by reference at the National Archives and Records Administration
(NARA). For information on the availability of this material at
NARA, call<PHONE_NUMBER>, or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued in Renton, Washington, on September 20, 2017.
Dionne Palermo,
Acting Director, System Oversight Division, Aircraft Certification
Service.
[FR Doc. 2017-20824 Filed 9-29-17; 8:45 am]
BILLING CODE 4910-13-P