[Federal Register: November 24, 2008 (Volume 73, Number 227)]
[Rules and Regulations]
[Page 70867-70868]
[DOCID:fr24no08-3]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 117

[USCG-2008-1028]

Drawbridge Operation Regulations; Connecticut River, Old Lyme,
CT, Maintenance

AGENCY: Coast Guard, DHS.

ACTION: Notice of temporary deviation from regulations.

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SUMMARY: The Commander, First Coast Guard District, has issued a
temporary deviation from the regulations governing the operation of the
Amtrak Railroad Bridge, across the Connecticut River, mile 3.4, at Old
Lyme, Connecticut. Under this temporary deviation the bridge may remain
in the closed position for nine days in December and twelve days in
January to facilitate required bridge maintenance.

DATES: This deviation is effective from December 5, 2008 through
January 26, 2009.

ADDRESSES: Documents indicated in this preamble as being available in
the docket are part of docket USCG-2008-1028 and are available online
at  http://www.regulations.gov. They are also available for inspection
or copying at two locations: the Docket Management Facility (M-30),
U.S. Department of Transportation, West Building Ground Floor, Room
W12-140, 1200 New Jersey Avenue, SE., Washington, DC 20590, between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays, and
the First Coast Guard District, Bridge Branch Office, 408 Atlantic
Avenue, Boston, Massachusetts, 02110, between 7 a.m. and 3 p.m., Monday
through Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: Judy Leung-Yee, Project Officer, First
Coast Guard District, at<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The Amtrak Railroad Bridge, across the
Connecticut River, mile 3.4, at Old Lyme, Connecticut, has a vertical
clearance in the closed position of 19 feet at mean high water and 22
feet at

mean low water. The existing regulations are listed at 33 CFR 117.205.
    The owner of the bridge, National Railroad Passenger Corporation
(Amtrak), requested a temporary deviation to facilitate scheduled
mechanical maintenance, tread and track plate replacement, at the
bridge.
    Under this temporary deviation the bridge may remain in the closed
position as follows:
    From 6 a.m. on December 5, 2008 through 6 a.m. on December 8, 2008.
    From 6 a.m. on December 12, 2008 through 6 a.m. on December 15,
2008.
    From 6 a.m. on December 19, 2008 through 6 a.m. on December 22,
2008.
    From 6 a.m. on January 2, 2009 through 6 a.m. on January 5, 2009.
    From 6 a.m. on January 9, 2009 through 6 a.m. on January 12, 2009.
    From 6 a.m. on January 16, 2009 through 6 a.m. on January 19, 2009.
    From 6 a.m. on January 23, 2009 through 6 a.m. on January 26, 2009.
    Vessels that can pass under the draw without a bridge opening may
do so at all times.
    In accordance with 33 CFR 117.35(e), the bridge must return to its
regular operating schedule immediately at the end of the designated
time period. This deviation from the operating regulations is
authorized under 33 CFR 117.35.

    Dated: November 10, 2008.
Gary Kassof,
Bridge Program Manager, First Coast Guard District.
[FR Doc. E8-27842 Filed 11-21-08; 8:45 am]

BILLING CODE 4910-15-P


[Federal Register Volume 83, Number 82 (Friday, April 27, 2018)]
[Notices]
[Page 18602]
[FR Doc No: 2018-08846]

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SECURITIES AND EXCHANGE COMMISSION

[Investment Company Act Release No. 33075; File No. 812-14857]

The Swiss Helvetia Fund, Inc., et al.

April 23, 2018.
AGENCY: Securities and Exchange Commission (``Commission'').

ACTION: Notice.

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    Notice of an application under section 6(c) of the Investment
Company Act of 1940 (``Act'') for an exemption from section 19(b) of
the Act and rule 19b-1 under the Act to permit a registered closed-end
investment company to make periodic distributions of long-term capital
gains more frequently than permitted by section 19(b) or rule 19b-1.

Applicants: The Swiss Helvetia Fund, Inc. (the ``Fund''), a non-
diversified closed-end investment company registered under the Act and
organized as a corporation under the laws of Delaware, and Schroder
Investment Management North America Inc., a corporation organized under
the laws of the state of Delaware (``SIMNA''), and Schroder Investment
Management North America Limited, a corporation organized under the
laws of the United Kingdom (``SIMNA Ltd.''), each registered under the
Investment Advisers Act of 1940, and serving as investment adviser and
sub-adviser to the Fund, respectively (together with the Fund, the
``Applicants'').\1\
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    \1\ Applicants request that the order also apply to each other
registered closed-end investment company advised or to be advised in
the future by SIMNA or SIMNA Ltd. or by an entity controlling,
controlled by, or under common control (within the meaning of
section 2(a)(9) of the Act) with SIMNA or SIMNA Ltd. (including any
successor in interest) (each such entity, together with SIMNA and
SIMNA Ltd., the ``Advisers'') that in the future seeks to rely on
the order (such investment companies, together with the Fund, are
collectively the ``Funds'' and, individually, a ``Fund''). A
successor in interest is limited to entities that result from a
reorganization into another jurisdiction or a change in the type of
business organization.

Filing Dates: The application was filed on December 22, 2017, and
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amended on April 12, 2018.

Hearing or Notification of Hearing: An order granting the application
will be issued unless the Commission orders a hearing. Interested
persons may request a hearing by writing to the Commission's Secretary
and serving applicants with a copy of the request, personally or by
mail. Hearing requests should be received by the Commission by 5:30
p.m. on May 18, 2018, and should be accompanied by proof of service on
applicants, in the form of an affidavit or, for lawyers, a certificate
of service. Pursuant to Rule 0-5 under the Act, hearing requests should
state the nature of the writer's interest, any facts bearing upon the
desirability of a hearing on the matter, the reason for the request,
and the issues contested. Persons who wish to be notified of a hearing
may request notification by writing to the Commission's Secretary.

ADDRESSES:
    The Commission: Secretary, U.S. Securities and Exchange Commission,
100 F Street NE, Washington, DC 20549-1090.
    Applicants: Carin F. Muhlbaum, Schroder Investment Management North
America Inc., 7 Bryant Park, New York, NY 10018 and Nicole M. Runyan,
Esq., Proskauer Rose LLP, Eleven Times Square, New York, NY 10036.

FOR FURTHER INFORMATION CONTACT: Jean E. Minarick, Senior Counsel at
(202) 551-6811, or Kaitlin C. Bottock, Branch Chief, at<PHONE_NUMBER>
(Division of Investment Management, Chief Counsel's Office).

SUPPLEMENTARY INFORMATION: The following is a summary of the
application. The complete application may be obtained via the
Commission's website by searching for the file number, or for an
applicant using the Company name box, at http://www.sec.gov/search/search.htm, or by calling<PHONE_NUMBER>.

Summary of the Application

    1. Section 19(b) of the Act generally makes it unlawful for any
registered investment company (``fund'') to make long-term capital
gains distributions more than once every twelve months. Rule 19b-1
under the Act limits to one the number of capital gain dividends, as
defined in section 852(b)(3)(C) of the Internal Revenue Code of 1986
(``Code,'' and such dividends, ``distributions''), that a fund may make
with respect to any one taxable year, plus a supplemental distribution
made pursuant to section 855 of the Code not exceeding 10% of the total
amount distributed for the year, plus one additional capital gain
dividend made in whole or in part to avoid the excise tax under section
4982 of the Code.
    2. Applicants believe that investors in certain closed-end funds
may prefer an investment vehicle that provides regular current income
through a fixed distribution policy (``Distribution Policy'').
Applicants propose that the Fund be permitted to adopt a Distribution
Policy, pursuant to which the Fund would distribute periodically to its
stockholders a fixed percentage of the market price of the Fund's
common stock at a particular point in time or a fixed percentage of net
asset value at a particular time or a fixed amount per share of common
stock, any of which may be adjusted from time to time.
    3. Applicants request an order under section 6(c) of the Act
granting an exemption from section 19(b) of the Act and rule 19b-1 to
permit a Fund to distribute periodic capital gain dividends (as defined
in section 852(b)(3)(C) of the Code) as frequently as twelve times in
any one taxable year in respect of its common stock and as often as
specified by, or determined in accordance with the terms of, any
preferred stock issued by the Fund. Section 6(c) of the Act provides,
in relevant part, that the Commission may exempt any person or
transaction from any provision of the Act to the extent that such
exemption is necessary or appropriate in the public interest and
consistent with the protection of investors and the purposes fairly
intended by the policy and provisions of the Act.
    4. Applicants state that any order granting the requested relief
will be subject to the terms and conditions stated in the application,
which generally are designed to address the concerns underlying section
19(b) and rule 19b-1, including concerns about proper disclosures and
shareholders' understanding of the source(s) of a Fund's distributions
and concerns about improper sales practices. Among other things, such
terms and conditions require that (1) the board of directors or
trustees of the Fund (the ``Board'') review such information as is
reasonably necessary to make an informed determination of whether to
adopt the proposed Distribution Policy and that the Board periodically
review the amount of the distributions in light of the investment
experience of the Fund, and (2) that the Fund's shareholders receive
appropriate disclosures concerning the distributions.

    For the Commission, by the Division of Investment Management,
under delegated authority.
Eduardo A. Aleman,
Assistant Secretary.
[FR Doc. 2018-08846 Filed 4-26-18; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 82, Number 189 (Monday, October 2, 2017)]
[Rules and Regulations]
[Pages 45713-45714]
[FR Doc No: 2017-20848]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2016-0398; Airspace Docket No. 17-ANE-2]

Amendment of Class E Airspace; Windsor Locks, CT

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: This action amends Class E airspace at Windsor Locks, CT, by
removing the Notice to Airmen (NOTAM) part-time status at Bradley
International Airport under Class E airspace designated as an extension
to a Class C surface area. This change enhances the safety and
management of instrument flight rules (IFR) operations at Bradley
International Airport under these Class E airspace designations. This
action also updates the geographic coordinates of the airport.

DATES: Effective 0901 UTC, December 7, 2017. The Director of the
Federal Register approves this incorporation by reference action under
title 1, Code of Federal Regulations, part 51, subject to the annual
revision of FAA Order 7400.11 and publication of conforming amendments.

ADDRESSES: FAA Order 7400.11B, Airspace Designations and Reporting
Points, and subsequent amendments can be viewed online at http://www.faa.gov/air_traffic/publications/. For further information, you can
contact the Airspace Policy Group, Federal Aviation Administration, 800
Independence Avenue SW., Washington, DC 20591; telephone: (202) 267-
8783. The Order is also available for inspection at the National
Archives and Records Administration (NARA). For information on the
availability of FAA Order 7400.11B at NARA, call<PHONE_NUMBER>, or go
to https://www.archives.gov/federal-register/cfr/ibr-locations.html.
    FAA Order 7400.11, Airspace Designations and Reporting Points, is
published yearly and effective on September 15.

FOR FURTHER INFORMATION CONTACT: John Fornito, Operations Support
Group, Eastern Service Center, Federal Aviation Administration, P.O.
Box 20636, Atlanta, Georgia 30320; telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Authority for This Rulemaking

    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the United States Code. 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. This rulemaking is promulgated under the authority described
in Subtitle VII, Part A, Subpart I, Section 40103. Under that section,
the FAA is charged with prescribing regulations to assign the use of
airspace necessary to ensure the safety of aircraft and the efficient
use of airspace. This regulation is within the scope of that authority
as it amends Class E airspace at Bradley International Airport, Windsor
Locks, CT, to support IFR operations under standard instrument approach
procedures at the airport.

History

    The FAA published a notice of proposed rulemaking (NPRM) in the
Federal Register (82 FR 27449, June 15, 2017) Docket No. FAA-2017-0398
to amend Class E surface area airspace, by removing the NOTAM part-time
status of the Class E airspace designated as an extension to a Class C
surface area. This change enhances the safety and management of IFR
operations at the airport. This action also updates the geographic
coordinates of the airport for Class E airspace designated as an
extension to a Class C surface area, and for Class E airspace extending
upward from 700 feet or more above the surface within a 10.9-mile
radius of Bradley International Airport, to coincide with the FAAs
aeronautical database.
    Interested parties were invited to participate in this rulemaking
effort by submitting written comments on the proposal to the FAA. No
comments were received.
    Class E airspace designations are published in Paragraph 6003, and
6005, respectively, of FAA Order 7400.11B, dated August 3, 2017, and
effective September 15, 2017, which is incorporated by reference in 14
CFR 71.1. The Class E airspace designations listed in this document
will be published subsequently in the Order.

Availability and Summary of Documents for Incorporation by Reference

    This document proposes to amend FAA Order 7400.11B, Airspace
Designations and Reporting Points, dated August 3, 2017, and effective
September 15, 2017. FAA Order 7400.11A is publicly available as listed
in the ADDRESSES section of this document. FAA Order 7400.11B lists
Class A, B, C, D, and E airspace areas, air traffic service routes, and
reporting points.

The Rule

    This action amends Title 14 Code of Federal Regulations (14 CFR)
part 71 by amending Class E airspace designated as an extension to a
Class C surface area, and Class E airspace extending upward from 700
feet or more above the surface at Bradley International Airport,
Windsor Locks, CT. The NOTAM part-time status is removed from the Class
E airspace area designated as an extension to a Class C surface area.
    Class E airspace designations are published in Paragraphs 6003 and
6005, respectively, of FAA Order 7400.11B, dated August 3, 2017, and
effective September 15, 2017, which is incorporated by reference in 14
CFR 71.1. The Class E airspace designations listed in this document
will be published subsequently in the Order.

Regulatory Notices and Analyses

    The FAA has determined that this regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
Therefore, this regulation: (1) Is not a ``significant regulatory
action'' under Executive Order 12866; (2) is not a ``significant rule''
under DOT Regulatory Policies and Procedures (44 FR 11034; February 26,
1979); and (3) does not warrant preparation of a regulatory evaluation
as the anticipated impact is so minimal. Since this is a routine matter
that only affects air traffic procedures and air navigation, it is
certified that this rule, when promulgated, does not have a significant
economic impact on a substantial number of small entities under the
criteria of the Regulatory Flexibility Act.

Environmental Review

    The FAA has determined that this action qualifies for categorical
exclusion under the National Environmental Policy Act in accordance
with FAA Order 1050.1F, ``Environmental Impacts: Policies and
Procedures,'' paragraph 5-6.5a. This airspace action is not expected to
cause any potentially significant environmental impacts, and no
extraordinary circumstances exist that warrant preparation of an
environmental assessment.

Lists of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

Adoption of the Amendment

    In consideration of the foregoing, the Federal Aviation
Administration amends 14 CFR part 71 as follows:

PART 71--DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND REPORTING POINTS

0
1. The authority citation for part 71 continues to read as follows:

    Authority: 49 U.S.C. 106(f), 106(g); 40103, 40113, 40120; E.O.
10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.

Sec.  71.1   [Amended]

0
 2. The incorporation by reference in 14 CFR 71.1 of Federal Aviation
Administration Order 7400.11B, Airspace Designations and Reporting
Points, dated August 3, 2017, effective September 15, 2017, is amended
as follows:

Paragraph 6003 Class E Airspace Designated as an Extension to a
Class C Surface Area.

* * * * *

ANE CT E3 Windsor Locks, CT [Amended]

Bradley International Airport, CT
    (Lat. 41[deg]56'21'' N., long 72[deg]41'00'' W.)

    That airspace extending upward from the surface within 3.2 miles
each side of the 224 bearing from Bradley International Airport,
extending from the 5-mile radius to 9.6 miles southwest of the
Bradley International Airport.

Paragraph 6005 Class E Airspace Areas Extending Upward From 700
Feet or More Above the Surface of the Earth.

* * * * *

ANE CT E5 Windsor Locks, CT [Amended]

Bradley International Airport, CT
    (Lat. 41[deg]56'21'' N., long. 72[deg]41'00'' W.)

    That airspace extending upward from 700 feet above the surface
within a 10.9-mile radius of Bradley International Airport.

    Issued in College Park, Georgia, on September 21, 2017.
Ryan W. Almasy,
Manager, Operations Support Group, Eastern Service Center, Air Traffic
Organization.
[FR Doc. 2017-20848 Filed 9-29-17; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 87, Number 68 (Friday, April 8, 2022)]
[Notices]
[Pages 20873-20875]
[FR Doc No: 2022-07614]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-D-1158]

Cybersecurity in Medical Devices: Quality System Considerations
and Content of Premarket Submissions; Draft Guidance for Industry and
Food and Drug Administration Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of the draft guidance entitled ``Cybersecurity in
Medical Devices: Quality System Considerations and Content of Premarket
Submissions.'' As more medical devices are becoming interconnected,
cybersecurity threats have become more numerous, more frequent, more
severe, and more clinically impactful. As a result, ensuring medical
device safety and effective includes adequate medical device
cybersecurity, as well as its security as part of the larger system. In
2018, FDA proposed updates to the final guidance, ``Content of
Premarket Submissions for Management of Cybersecurity in Medical
Devices,'' and issued a draft guidance of the same name. This draft
guidance replaces the 2018 draft guidance. This draft guidance is
intended to further emphasize the importance of ensuring that devices
are designed securely, are designed to be capable of mitigating
emerging cybersecurity risks throughout the Total Product Life Cycle,
and to clearly outline FDA's recommendations for premarket submission
content to address cybersecurity concerns. This draft guidance is not
final nor is it for implementation at this time.

DATES: Submit either electronic or written comments on the draft
guidance by July 7, 2022 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.

ADDRESSES: You may submit comments on any guidance at any time 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-2021-D-1158 for ``Cybersecurity in Medical Devices: Quality System
Considerations and Content of Premarket Submissions.'' Received
comments 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.'' The Agency 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 to 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 this 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>.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    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 draft guidance document entitled
``Cybersecurity in Medical Devices: Quality System Considerations and
Content of Premarket Submissions'' to the Office of Policy, 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
(CBER), 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.

FOR FURTHER INFORMATION CONTACT: Suzanne Schwartz, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 5410, Silver Spring, MD 20993-0002, 301-
796-6937; 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

    The need for effective cybersecurity to reasonably ensure medical
device safety and effectiveness has become more important with the
increasing use of wireless, internet- and network-connected devices,
portable media (e.g., USB or CD), and the frequent electronic exchange
of medical device-related health information. In addition,
cybersecurity threats to the healthcare sector have become more
frequent, more severe, and carry increased potential for clinical
impact. Cybersecurity incidents have rendered medical devices and
hospital networks inoperable, disrupting the delivery of patient care
across healthcare facilities in the United States and globally. Such
cyber attacks and exploits can delay diagnoses and/or treatment and may
lead to patient harm.
    Although FDA issued guidance providing recommendations for device
cybersecurity information in premarket submissions in 2014,\1\ the
rapidly evolving landscape, and the increased understanding of the
threats and their potential mitigations, necessitate an updated
approach. As such, FDA issued a draft guidance in 2018 entitled
``Content of Premarket Submissions for Management of Cybersecurity in
Medical Devices.''
---------------------------------------------------------------------------

    \1\ Content of Premarket Submissions for Management of
Cybersecurity in Medical Devices--Guidance for Industry and Food and
Drug Administration Staff at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/content-premarket-submissions-management-cybersecurity-medical-devices-0.
---------------------------------------------------------------------------

    Given the rapidly evolving device cybersecurity landscape, FDA is
issuing this draft guidance, which replaces the 2018 draft guidance, to
further emphasize the importance of ensuring that devices are designed
securely, are designed to be capable of mitigating emerging
cybersecurity risks throughout the Total Product Life Cycle, and to
clearly outline FDA's recommendations for premarket submission content
to address cybersecurity concerns, including device labeling. These
recommendations can facilitate an efficient premarket review process
and help ensure that marketed medical devices are sufficiently
resilient to cybersecurity threats.
    This draft guidance supplants the draft guidance entitled,
``Content of Premarket Submissions for Management of Cybersecurity in
Medical Devices'' issued October 18, 2018, and takes into consideration
comments received on the 2018 draft guidance (83 FR 52835;

https://www.govinfo.gov/content/pkg/FR-2018-10-18/pdf/2018-22697.pdf)
and input gained from the public workshop entitled, ``Content of
Premarket Submissions for Management of Cybersecurity in Medical
devices'' held on January 29-30, 2019.\2\ Several changes were made in
this draft guidance, including a change in title to better capture the
scope of the current draft guidance, document structure change to align
with use of a Secure Product Framework, removal of risk tiers,
replacement of the Cybersecurity Bill of Materials with Software Bill
of Materials, additional clarification regarding premarket submission
document requests throughout the draft guidance, and addition of
Investigational Device Exemptions to the scope.
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    \2\ https://wayback.archive-it.org/7993/20201222110245/https://www.fda.gov/medical-devices/workshops-conferences-medical-devices/public-workshop-content-premarket-submissions-management-cybersecurity-medical-devices-january-29-30.
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    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on
``Cybersecurity in Medical Devices: Quality System Considerations and
Content of Premarket Submissions.'' It does not establish any rights
for any person and is not binding on FDA or the public. You can use an
alternative approach if it satisfies the requirements of the applicable
statutes and regulations.

II. Electronic Access

    Persons interested in obtaining a copy of the draft 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 https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products. This draft guidance is also
available at https://www.regulations.gov and at https://www.fda.gov/regulatory-information/search-fda-guidance-documents or https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances. Persons unable to download
an electronic copy of ``Cybersecurity in Medical Devices: Quality
System Considerations and Content of Premarket Submissions'' may send
an email request to [email protected] to receive an electronic
copy of the document. Please use the document number 1825-R1 and
complete title to identify the guidance you are requesting.

III. Paperwork Reduction Act of 1995

    While this guidance contains no collection of information, it does
refer to previously approved FDA collections of information. Therefore,
clearance by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not
required for this guidance. The previously approved collections of
information are subject to review by OMB under the PRA. The collections
of information in the following FDA regulations, guidance, and forms
have been approved by OMB as listed in the following table:

------------------------------------------------------------------------
                                                            OMB control
    21 CFR part or guidance               Topic                 No.
------------------------------------------------------------------------
807, subpart E.................  Premarket notification.       0910-0120
814, subparts A through E......  Premarket approval.....       0910-0231
814, subpart H.................  Humanitarian Device           0910-0332
                                  Exemption.
812............................  Investigational Device        0910-0078
                                  Exemption.
860, subpart D.................  De Novo classification        0910-0844
                                  process.
``Requests for Feedback on       Q-submissions..........       0910-0756
 Medical Device Submissions:
 The Pre-Submission Program and
 Meetings with Food and Drug
 Administration Staff''.
800, 801, and 809..............  Medical Device Labeling       0910-0485
                                  Regulations.
820............................  Current Good                  0910-0073
                                  Manufacturing Practice
                                  (CGMP); Quality System
                                  (QS) Regulation.
------------------------------------------------------------------------

    Dated: April 5, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-07614 Filed 4-7-22; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 79, Number 41 (Monday, March 3, 2014)]
[Rules and Regulations]
[Pages 11691-11693]
[FR Doc No: 2014-03825]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2013-0687; Directorate Identifier 2012-NM-118-AD;
Amendment 39-17767; AD 2014-04-08]
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 all
Bombardier, Inc. Model CL-600-2B19 (Regional Jet Series 100 & 440)
airplanes. This AD was prompted by reports of burr marks on the primary
wheels, and cracked rings on the primary wheel shaft, on certain
horizontal stabilizer trim actuators (HSTAs). This AD requires
replacing certain HSTAs. We are issuing this AD to prevent burr marks
on the primary wheels, and cracked rings on the primary wheel shaft, on
certain HSTAs, which may lead to a disconnect of the pitch trim surface
and subsequent loss of pitch control, resulting in loss of control of
the airplane.

DATES: This AD becomes effective April 7, 2014.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in this AD as of April 7,
2014.

ADDRESSES: You may examine the AD docket on the Internet at http://www.regulations.gov/#!docketDetail;D=FAA-2013-0687; or in person at the
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.
    For service information identified in this AD, contact Bombardier,
Inc., 400 C[ocirc]te-Vertu Road West, Dorval, Qu[eacute]bec H4S 1Y9,
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
Airplane Directorate, 1601 Lind Avenue SW., Renton, WA. For information
on the availability of this material at the FAA, call<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Cesar Gomez, Aerospace Engineer,
Airframe and Mechanical Systems Branch, ANE-171, FAA, New York Aircraft
Certification Office (ACO), 1600 Stewart Avenue, Suite 410, Westbury,
NY 11590; telephone<PHONE_NUMBER>; 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 all Bombardier, Inc. Model
CL-600-2B19 (Regional Jet Series 100 & 440) airplanes. The NPRM
published in the Federal Register on August 13, 2013 (78 FR 49227). The
NPRM was prompted by reports of burr marks on the primary wheels, and
cracked rings on the primary wheel shaft, on certain HSTAs. The NPRM
proposed to require replacing certain HSTAs. We are issuing this AD to
prevent burr marks on the primary wheels, and cracked rings on the
primary wheel shaft, on certain HSTAs, which may lead to a disconnect
of the pitch trim surface and subsequent loss of pitch control,
resulting in loss of control of the airplane.
    Transport Canada Civil Aviation (TCCA), which is the aviation
authority for Canada, has issued Canadian Airworthiness Directive CF-
2012-18, dated May 29, 2012 (referred to after this as the Mandatory
Continuing Airworthiness Information, or ``the MCAI''), to correct an
unsafe condition for the specified products. The MCAI states:

    It was discovered that a number of primary wheels on the HSTA P/
N [part number] 601R92305-5 (or vendor P/N 8396-4) had burr marks.
Investigation revealed that the burr marks were a result of
incorrectly using the manufacturing process. In addition, some rings
that were fitted on the primary wheel shaft were found cracked. If
not corrected, this condition may lead to a disconnect of the pitch
trim surface and subsequent loss of pitch control.
    This [Canadian] AD mandates the removal of the affected units
that have the above described manufacturing defect.

Corrective actions include replacement of certain HSTAs. You may
examine the MCAI in the AD docket on the Internet at http://www.regulations.gov/#!documentDetail;D=FAA-2013-0687-0003.

Comments

    We gave the public the opportunity to participate in developing
this AD. We have considered the comment received. The following
presents the comment received on the proposal (78 FR 49227, August 13,
2013) and the FAA's response to the comment.

Request To Revise the Applicability

    Air Wisconsin Airlines requested that we limit the applicability of
the NPRM (78 FR 49227, August 13, 2013) to Model CL-6-2B19 (Regional
Jet Series 100 & 440) airplanes ``equipped with HSTAs having part
number (P/N) 601R92305-5 or vendor P/N 8396-4, with serial numbers (S/
N)s as identified in paragraph (g) of this AD.''
    We disagree with the commenter's request. The intent of the
applicability in the NPRM (78 FR 49227, August 13, 2013) and this final
rule was to capture all possible airplanes that could have an affected
HSTA, or on which an affected HSTA could be installed in the future.
This issue was coordinated with TCCA.
    The parts installation limitation, which applies to all Model CL-
600-2B19 (Regional Jet Series 100 & 440) airplanes, is retained in this
final rule. This provision matches the intent of Canadian AD CF-2012-
18, dated May 29, 2012. We have made no changes to this final rule in
this regard.
    Also, we have specified serial numbers 7003 and subsequent (which
includes all serial numbers) in paragraph (c) in this final rule, which
corresponds with the Applicability of Canadian AD CF-2012-18, dated May
29, 2012.

Conclusion

    We reviewed the relevant data, considered the comment received, 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 (78 FR 49227, August 13, 2013) for correcting the unsafe
condition; and
     Do not add any additional burden upon the public than was
already proposed in the NPRM (78 FR 49227, August 13, 2013).

Costs of Compliance

    We estimate that this AD affects 575 airplanes of U.S. registry.
    We also estimate that it will take about 19 work-hours per product
to comply with the basic requirements of this AD. The average labor
rate is $85 per work-hour. Required parts will cost about $0 per
product. Based on these figures, we estimate the cost of this AD on
U.S. operators to be $928,625, or $1,615 per product.

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.

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.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov/#!docketDetail;D=FAA-2013-0687; 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 Operations office (telephone (800)
647-5527) is in the ADDRESSES section.

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 AD:

2014-04-08 Bombardier, Inc.: Amendment 39-17767. Docket No. FAA-
2013-0687; Directorate Identifier 2012-NM-118-AD.

(a) Effective Date

    This airworthiness directive (AD) becomes effective April 7,
2014.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to all Bombardier, Inc. Model CL-600-2B19
(Regional Jet Series 100 & 440) airplanes, certificated in any
category, serial numbers 7003 and subsequent.

(d) Subject

    Air Transport Association (ATA) of America Code 27, Flight
Controls.

(e) Reason

    This AD was prompted by reports of burr marks on the primary
wheels, and cracked rings on the primary wheel shaft, on certain
horizontal stabilizer trim actuators (HSTAs). We are issuing this AD
to prevent burr marks on the primary wheels, and cracked rings on
the primary wheel shaft, on certain HSTAs, which may lead to a
disconnect of the pitch trim surface and subsequent loss of pitch
control, resulting in loss of control of the airplane.

(f) Compliance

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

(g) Inspection

    Within 1,000 flight hours or 4 months after the effective date
of this AD, whichever occurs first, inspect to determine if any HSTA
having part number (P/N) 601R92305-5 or vendor P/N 8396-4, with
serial numbers (S/N)s 287, 724, 813, 841, 998, 1031, 1035, 1049,
1053, 1067, 1068, 1136, 1252, 1268, 1303, 1319, 1338, 1354, 1374,
1378, 1445, 1470, 1498, 1513, 1546, 1632, 1736, 1766, 1846, 1849,
2002 through 2009, 2011, 2013 through 2016, 2019, 2020, and 2022 is
installed. A review of airplane maintenance records is acceptable in
lieu of this inspection if the part number of the HSTA can be
conclusively determined from that review.

(h) Replacement

    Within 1,000 flight hours or 4 months after the effective date
of this AD, whichever occurs first, replace any affected HSTA
identified in paragraph (g) of this AD with a serviceable HSTA, in
accordance with the Accomplishment Instructions of Bombardier
Service Bulletin 601R-27-159, dated June 15, 2011.

(i) Parts Installation Limitations

    As of the effective date of this AD, no person may install any
HSTA having P/N 601R92305-5 or vendor P/N 8396-4 with a serial
number listed in paragraph (g) of this AD, unless the serial number
has the suffix ``A'' beside it.

(j) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager, New
York Aircraft Certification Office, (ACO), ANE-170, 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 ACO, send it to ATTN: Program Manager, Continuing
Operational Safety, FAA, New York ACO, 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. The AMOC approval letter must specifically reference this
AD.
    (2) Airworthy Product: For any requirement in this AD to obtain
corrective actions from a manufacturer or other source, use these
actions if they are FAA-approved. Corrective actions are considered
FAA-approved if they are approved by the State of Design Authority
(or their delegated agent). You are required to assure the product
is airworthy before it is returned to service.

(k) Related Information

    Refer to Mandatory Continuing Airworthiness Information Canadian
Airworthiness Directive CF-2012-18, dated May 29, 2012, for related
information. This MCAI may be found in the AD docket on the Internet
at http://www.regulations.gov/#!documentDetail;D=FAA-2013-0687-0003.

(l) 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 601R-27-159, dated June 15,
2011.
    (ii) Reserved.
    (3) For service information identified in this AD, contact
Bombardier, Inc., 400 C[ocirc]te-Vertu Road West, Dorval,
Qu[eacute]bec H4S 1Y9, Canada; telephone<PHONE_NUMBER>; fax 514-855-
7401; email<EMAIL_ADDRESS>Internet http://www.bombardier.com.
    (4) You may view this service information at the FAA, Transport
Airplane Directorate,

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 February 10, 2014.
Jeffrey E. Duven,
Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2014-03825 Filed 2-28-14; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 75, Number 67 (Thursday, April 8, 2010)]
[Rules and Regulations]
[Pages 17863-17865]
[FR Doc No: 2010-7878]

=======================================================================
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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R03-OAR-2009-0712; FRL-9134-9]

Approval and Promulgation of Air Quality Implementation Plans;
Delaware; Reasonable Further Progress Plan, 2002 Base Year Inventory,
Reasonably Available Control Measures, Contingency Measures, and
Transportation Conformity Budgets for the Delaware Portion of the
Philadelphia 1997 8-Hour Ozone Moderate Nonattainment Area

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: EPA is approving a revision to the Delaware State
Implementation Plan (SIP) to meet the reasonable further progress (RFP)
requirements of the Clean Air Act (CAA) for the Delaware portion of the
Philadelphia 1997 8-hour ozone moderate nonattainment area. EPA is also
approving the RFP plan's motor vehicle emissions budgets (MVEBs), the
2002 base year emissions inventory, contingency measures, and the
reasonably available control measure (RACM) analysis associated with
this revision. EPA is approving the SIP revision because it satisfies
the requirements for the 1997 8-hour ozone national ambient air quality
standard (NAAQS) nonattainment areas classified as moderate and
demonstrates further progress in reducing ozone precursors. EPA is
approving the SIP revision pursuant the CAA and EPA's regulations.

DATES: Effective Date: This final rule is effective on May 10, 2010.

ADDRESSES: EPA has established a docket for this action under Docket ID
Number EPA-R03-OAR-2009-0712. All documents in the docket are listed in
the http://www.regulations.gov Web site. Although listed in the
electronic docket, some information is not publicly available, i.e.,
confidential business information (CBI) or other information whose
disclosure is restricted by statute. Certain other material, such as
copyrighted material, is not placed on the Internet and will be
publicly available only in hard copy form. Publicly available docket
materials are available either electronically through http://www.regulations.gov or in hard copy for public inspection during normal
business hours at the Air Protection Division, U.S. Environmental
Protection Agency, Region III, 1650 Arch Street, Philadelphia,
Pennsylvania

19103. Copies of the State submittal are available at the Delaware
Department of Natural Resources & Environmental Control, 89 Kings
Highway, P.O. Box 1401, Dover, Delaware 19903.

FOR FURTHER INFORMATION CONTACT: Rose Quinto,<PHONE_NUMBER>, or by e-
mail at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    On January 15, 2010 (75 FR 2452), EPA published a notice of
proposed rulemaking (NPR) for the State of Delaware. The NPR proposed
approval of the 15 percent RFP plan, the RFP plan's 2008 MVEBs, the
2002 base year emissions inventory, contingency measures, and the RACM
analysis for the Delaware portion of the Philadelphia 1997 8-hour ozone
moderate nonattainment area. The formal SIP revision was submitted by
the Delaware Department of Natural Resources and Environmental Control
on June 13, 2007.

II. Summary of SIP Revision

    The SIP revision addresses emissions inventory, RACM, contingency
measures and the RFP requirements for the 1997 8-hour ozone NAAQS for
the Delaware portion of the Philadelphia moderate nonattainment area.
The SIP revision also establishes MVEBs for 2008. Other requirements of
the SIP revision and the rationale for EPA's proposed action are
explained in the NPR and will not be restated here. No public comments
were received on the NPR.

III. Final Action

    EPA is approving the Delaware SIP revision that meets the RFP
requirements of the CAA for the Delaware portion of the Philadelphia
1997 8-hour ozone moderate nonattainment area. EPA is also approving
the RFP plan's MVEBs, the 2002 base year emissions inventory,
contingency measures, and RACM analysis associated with the SIP
revision. The SIP revision satisfies the requirements for the 1997 8-
hour ozone NAAQS nonattainment areas classified as moderate and
demonstrates further progress in reducing ozone precursors.

IV. Statutory and Executive Order Reviews

A. General Requirements

    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, EPA's role is to approve state choices,
provided that they meet the criteria of the CAA. Accordingly, this
action merely approves state law as meeting Federal requirements and
does not impose additional requirements beyond those imposed by state
law. For that reason, this action:
     Is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive Order
12866 (58 FR 51735, October 4, 1993);
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the CAA; and
     Does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
    In addition, this rule does not have tribal implications as
specified by Executive Order 13175 (65 FR 67249, November 9, 2000),
because the SIP is not approved to apply in Indian country located in
the state, and EPA notes that it will not impose substantial direct
costs on tribal governments or preempt tribal law.

B. Submission to Congress and the Comptroller General

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this action and
other required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2).

C. Petitions for Judicial Review

    Under section 307(b)(1) of the CAA, petitions for judicial review
of this action must be filed in the United States Court of Appeals for
the appropriate circuit by June 7, 2010. Filing a petition for
reconsideration by the Administrator of this final rule does not affect
the finality of this action for the purposes of judicial review nor
does it extend the time within which a petition for judicial review may
be filed, and shall not postpone the effectiveness of such rule or
action. This action pertaining to the Delaware's RFP Plan, 2002 base
year emissions inventory, contingency measures, RACM analysis, and
transportation conformity budgets, may not be challenged later in
proceedings to enforce its requirements. (See section 307(b)(2).)

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Nitrogen dioxide,
Ozone, Reporting and recordkeeping requirements, Volatile organic
compounds.

    Dated: March 25, 2010.
W.C. Early,
Acting Regional Administrator, EPA Region III.

0
40 CFR part 52 is amended as follows:

PART 52--[AMENDED]

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

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

Subpart I--Delaware

0
2. In Sec.  52.420, the table in paragraph (e) is amended by adding at
the end of the table, the entries for Reasonable Further Progress Plan
(RFP), Reasonably Available Control Measures and Contingency Measures;
2002 Base Year Inventory for VOC, NOX and CO; and 2008 RFP
Transportation Conformity Budgets for the Delaware Portion of the
Philadelphia 1997 8-hour Ozone Moderate Nonattainment Area. The
amendments read as follows:

Sec.  52.420  Identification of plan.

* * * * *
    (e) * * *

----------------------------------------------------------------------------------------------------------------
    Name of non-regulatory SIP          Applicable           State                                Additional
             revision                geographic area    submittal date   EPA approval date       explanation
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
Reasonable Further Progress Plan   Delaware portion of         6/13/07  4/8/10 [Insert page  ...................
 (RFP), Reasonably Available        the Philadelphia                     number where the
 Control Measures, and              1997 8-hour ozone                    document begins].
 Contingency Measures.              moderate
                                    nonattainment area.
2002 Base Year Inventory for VOC,  Delaware portion of         6/13/07  4/8/10 [Insert page  ...................
 NOX, and CO.                       the Philadelphia                     number where the
                                    1997 8-hour ozone                    document begins].
                                    moderate
                                    nonattainment area.
2008 RFP Transportation            Delaware portion of         6/13/07  4/8/10 [Insert page  ...................
 Conformity Budgets.                the Philadelphia                     number where the
                                    1997 8-hour ozone                    document begins].
                                    moderate
                                    nonattainment area.
----------------------------------------------------------------------------------------------------------------

0
3. Section 52.423 is amended by revising the section heading and by
adding paragraph (b) to read as follows:

Sec.  52.423  Base Year Emissions Inventory.

* * * * *
    (b) EPA approves as a revision to the Delaware State Implementation
Plan the 2002 base year emissions inventories for the Delaware portion
of the Philadelphia 1997 8-hour ozone moderate nonattainment area
submitted by the Secretary of the Department of Natural Resources and
Environmental Control on June 13, 2007. This submittal consists of the
2002 base year point, area, non-road mobile, and on-road mobile source
inventories in area for the following pollutants: Volatile organic
compounds (VOC), carbon monoxide (CO) and nitrogen oxides
(NOX).

0
4. Section 52.426 is amended by adding paragraphs (g) and (h) to read
as follows:

Sec.  52.426  Control strategy plans for attainment and rate-of-
progress: Ozone.

* * * * *
    (g) EPA approves revisions to the Delaware State Implementation
Plan consisting of the 2008 reasonable further progress (RFP) plan,
reasonably available control measures, and contingency measures for the
Delaware portion of the Philadelphia 1997 8-hour ozone moderate
nonattainment area submitted by the Secretary of the Department of
Natural Resources and Environmental Control on June 13, 2007.
    (h) EPA approves the following 2008 RFP motor vehicle emissions
budgets (MVEBs) for the Delaware portion of the Philadelphia 1997 8-
hour ozone moderate nonattainment area submitted by the Secretary of
the Department of Natural Resources and Environmental Control on June
13, 2007:

 Transportation Conformity Emissions Budgets for the Delaware Portion of the Philadelphia Area for the 2008 Rate
                                                of Progress Plan
----------------------------------------------------------------------------------------------------------------
                                                2008 Emissions  (tons per day)
                   County                    ------------------------------------   Effective date of adequacy
                                                     VOC               NOX         determination or SIP approval
----------------------------------------------------------------------------------------------------------------
Kent........................................              4.14              9.68  January 5, 2009, (73 FR
                                                                                77682), published December
                                                                                19, 2008.
New Castle..................................             10.61             21.35
Sussex......................................              7.09             12.86
                                             ------------------------------------
    State Total.............................             21.84             43.89
----------------------------------------------------------------------------------------------------------------

[FR Doc. 2010-7878 Filed 4-7-10; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 81, Number 147 (Monday, August 1, 2016)]
[Proposed Rules]
[Page 50416]
[FR Doc No: 2016-17905]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R09-OAR-2016-0262; FRL-9948-09-Region 9]

Approval of California Air Plan Revisions, Placer County Air
Pollution Control District and Ventura County Air Pollution Control
District

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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

SUMMARY: The Environmental Protection Agency (EPA) is proposing to
approve revisions to the Placer County Air Pollution Control District
(PCAPCD) and Ventura County Air Pollution Control District (VCAPCD)
portion of the California State Implementation Plan (SIP). These
revisions concern oxides of nitrogen (NOX) and carbon
monoxide emissions from stationary gas turbines, boilers, steam
generators, and process heaters. We are proposing to approve local
rules to regulate these emission sources under the Clean Air Act (CAA
or the Act).

DATES: Any comments on this proposal must arrive by August 31, 2016.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R09-
OAR-2016-0262 at http://www.regulations.gov, or via email to Andrew
Steckel, Rules Office Chief, at<EMAIL_ADDRESS>For comments
submitted at Regulations.gov, follow the online instructions for
submitting comments. Once submitted, comments cannot be edited or
removed from Regulations.gov. For either manner of submission, 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 http://www2.epa.gov/dockets/commenting-epa-dockets.

FOR FURTHER INFORMATION CONTACT: Kevin Gong, EPA Region IX, (415) 972-
3073<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document, ``we,'' ``us'' and
``our'' refer to the EPA. This proposal addresses the following local
rules: PCAPCD Rule 250, ``Stationary Gas Turbines,'' and VCAPCD Rule
74.15.1, ``Boilers, Steam Generators, and Process Heaters.'' In the
Rules and Regulations section of this Federal Register, we are
approving these local rules in a direct final action without prior
proposal because we believe these SIP revisions are not controversial.
If we receive adverse comments, however, we will publish a timely
withdrawal of the direct final rule and address the comments in
subsequent action based on this proposed rule. Please note that if we
receive adverse comment on a particular rule, we may adopt as final the
rule that is not the subject of an adverse comment.
    We do not plan to open a second comment period, so anyone
interested in commenting should do so at this time. If we do not
receive adverse comments, no further activity is planned. For further
information, please see the direct final action.

    Dated: June 14, 2016.
Alexis Strauss,
Acting Regional Administrator, Region IX.
[FR Doc. 2016-17905 Filed 7-29-16; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 83, Number 97 (Friday, May 18, 2018)]
[Notices]
[Pages 23306-23310]
[FR Doc No: 2018-10603]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-83227; File No. SR-FINRA-2018-019]

Self-Regulatory Organizations; Financial Industry Regulatory
Authority, Inc.; Notice of Filing of a Proposed Rule Change Relating To
Create a Fee and Honorarium for Late Cancellation of a Prehearing
Conference

May 14, 2018.
    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 May 4, 2018, Financial Industry Regulatory Authority, Inc.
(``FINRA'') filed with the Securities and Exchange Commission (``SEC''
or ``Commission'') the proposed rule change as described in Items I,
II, and III below, which Items have been prepared by FINRA. 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

    FINRA is proposing to amend FINRA Rules 12500 and 12501 of the Code
of Arbitration Procedure for Customer Disputes (``Customer Code'') and
FINRA Rules 13500 and 13501 of the Code of Arbitration Procedure for
Industry Disputes (``Industry Code'' and together, ``Codes''), to
charge a $100 per-arbitrator fee to parties who request cancellation of
a prehearing conference within three business days before a scheduled
prehearing conference. The proposed rule change would also amend FINRA
Rules 12214(a) and 13214(a) of the Codes to create a $100 honorarium to
pay each arbitrator scheduled to attend a prehearing conference that
was cancelled within three business days of the prehearing conference.
    The text of the proposed rule change is available on FINRA's
website at http://www.finra.org, at the principal office of FINRA 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, FINRA 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. FINRA 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
Introduction
    FINRA proposes to charge parties to an arbitration a $100 per-
arbitrator fee if a prehearing conference is cancelled \3\ at the
request of one or more parties that was submitted within three business
days before a scheduled prehearing conference (``late cancellation
fee''). FINRA is also proposing to pay a $100 honorarium to each
arbitrator who was scheduled to attend the prehearing conference that
was cancelled within three business days of the prehearing conference.
---------------------------------------------------------------------------

    \3\ References to cancellations of prehearing conferences
include postponements of such conferences.
---------------------------------------------------------------------------

Background

    The Codes have several rules that address postponements and
cancellations of hearings.\4\ FINRA Rules 12601(b)(1) and 13601(b)(1)
provide that for each postponement agreed to by the parties, or granted
upon request of one or more parties, FINRA assesses a postponement fee
to the parties, equal to the applicable hearing session fee.\5\ In
addition, under FINRA Rules 12601(b)(2) and 13601(b)(2), a party or
parties that make postponement requests within 10 days before a
scheduled hearing session are required to pay a $600 per-arbitrator
late cancellation fee.\6\ Finally, if a hearing is cancelled or
postponed due to settlement or withdrawal of a claim, FINRA Rules
12902(d) and 13902(d) provide that if FINRA receives a settlement or
withdrawal notice 10 days or fewer prior to the date that the hearing
is scheduled to begin, parties that paid a filing fee will not be
entitled to any refund of the filing fee.\7\
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    \4\ A hearing is a meeting between the arbitrators and parties
to determine the merits of the arbitration. See FINRA Rules 12100(o)
and 13100(o).
    \5\ These rules also permit the panel to allocate the fee among
the party or parties that agreed to or requested the postponement,
to assess part or all of any postponement fees against a party that
did not request the postponement if the panel determines that the
non-requesting party caused or contributed to the need for the
postponement, and to waive the fees. This fee is paid to FINRA and
not passed through to the arbitrators.
    \6\ These rules also permit the panel to allocate the $600 per-
arbitrator fee among the requesting parties if more than one party
requests postponement, to allocate all or a portion of the $600 per-
arbitrator fee to the non-requesting party or parties if the
arbitrators determine that the non-requesting party or parties
caused or contributed to the need for the postponement, and to use
its discretion to waive the fee in the event of an extraordinary
circumstance, provided verification of such circumstance is
received. See FINRA Rules 12601(b)(2) and 13601(b)(2).
    \7\ Customers, associated persons, and other non-members who
file a claim, counterclaim, cross claim or third party claim must
pay a filing fee to initiate an arbitration, unless the fee is
deferred. See FINRA Rule 12900(a)(1); see also FINRA Rule
13900(a)(1) (addressing filing fees for associated persons).
---------------------------------------------------------------------------

    FINRA believes that it is appropriate to address late cancellations
of prehearing conferences by charging a late cancellation fee to the
parties. In addition, FINRA proposes to pay an honorarium in the same
amount to those

arbitrators who were scheduled to attend the prehearing conference.
    Prehearing conferences are typically scheduled before the hearing
on the merits begins.\8\ During these conferences, the arbitrator or
panel meets with the parties, either in person or by telephone, to set
discovery, briefing, and motions deadlines, to schedule subsequent
hearing sessions, and to address other preliminary matters.\9\ A
prehearing conference may also address other outstanding matters, such
as discovery disputes or substantive motions (e.g., motions to dismiss
or motions to amend).\10\
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    \8\ See FINRA Rules 12100(w) and 13100(w).
    \9\ See FINRA Rules 12500(c) and 13500(c).
    \10\ See FINRA Rules 12501(b) and 13501(b).
---------------------------------------------------------------------------

    Prehearing conferences currently can be cancelled by the parties up
to and including on the same day without penalty, unlike late
postponement of arbitration hearings.\11\ Considerable preparation by
arbitrators and logistical work by FINRA staff is required prior to
prehearing conferences. Late cancellations of prehearing conferences
that occur within three or fewer business days of a scheduled
prehearing conference typically cause the most problems for
arbitrators. In FINRA's experience, these late cancellations often
result in scheduling inconvenience for arbitrators, uncompensated work
by arbitrators,\12\ and an operational challenge for FINRA staff who
must quickly notify other parties and the arbitrator or panel about the
cancellation.
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    \11\ See generally FINRA Rules 12601(b) and 13601(b).
    \12\ In the past, arbitrators have resigned from the roster
because FINRA's dispute resolution forum does not provide a payment
to arbitrators for cancellations of prehearing conferences. FINRA
notes that one reason former arbitrators have given for their
resignation is the lack of compensation for prehearing conferences
that are cancelled on short notice. FINRA has identified 17 separate
complaints relating to 22 arbitrators with respect to the late
cancellations of prehearing conferences.
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Proposed Rule Change

Late Cancellation Fee for Prehearing Conferences

    FINRA is proposing to amend FINRA Rules 12500 and 12501 of the
Customer Code and FINRA Rules 13500 and 13501 of the Industry Code,\13\
which govern prehearing conferences, to provide that if a cancellation
request is agreed to by the parties or requested by one or more parties
within three business days before a scheduled prehearing conference and
granted, the party or parties shall be charged a fee of $100 per
arbitrator scheduled to attend the prehearing conference. If more than
one party requests the cancellation, the arbitrator(s) may allocate the
$100 per-arbitrator fee between or among the requesting parties. If one
party requests the cancellation, the arbitrator(s) shall allocate the
fee to that party; provided, however, the arbitrator(s) may allocate
all or a portion of the $100 per-arbitrator fee to the non-requesting
party or parties if the arbitrator(s) determine that the non-requesting
party or parties caused or contributed to the need for the
cancellation. In the event that an extraordinary circumstance prevents
a party or parties from making a timely cancellation request, the
arbitrator(s) may use their discretion to waive the fee, provided a
written explanation of such circumstance is received.
---------------------------------------------------------------------------

    \13\ To simplify this explanation, FINRA's discussion of the
proposed changes focuses on changes to the Customer Code. However,
the proposed changes also apply to the Industry Code.
---------------------------------------------------------------------------

    Under the proposed rule change, if a party requests or the parties
agree to cancel a prehearing conference within three business days of a
scheduled prehearing conference, the $100 per-arbitrator fee would be
charged as a fee assessment at the time the case is closed. The date of
the party's or parties' cancellation request controls whether the fee
is assessed, not the date of the arbitrators' decision on such a
request, if a decision is required.\14\ For example, if a party
requests cancellation of the prehearing conference five business days
before the scheduled prehearing conference, but the arbitrators rule on
the request two business days before the scheduled conference would be
held, the party would not be assessed a late cancellation fee under the
proposed rule. If the arbitrators cancel a prehearing conference on
their own, the parties would not be charged.
---------------------------------------------------------------------------

    \14\ A decision would be required if only one party requests
that the prehearing conference be cancelled.
---------------------------------------------------------------------------

    In the event of a cancellation, a party or the parties would be
charged only for those arbitrators who were scheduled to attend the
prehearing conference. For example, after the parties complete the
arbitrator selection process and a panel is appointed,\15\ the Director
of the Office of Dispute Resolution \16\ (``Director'') will schedule
an Initial Prehearing Conference (``IPHC''),\17\ during which the
parties and arbitrators meet initially, usually by telephone. If the
amount of the claim is more than $100,000, the panel must consist of
three arbitrators,\18\ all of whom would participate in the IPHC. The
Director will typically appoint the chairperson of the panel to preside
over prehearing conferences to resolve discovery issues.\19\
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    \15\ See generally Part IV (Appointment, Disqualification, and
Authority of Arbitrators) of the FINRA Rule 12000 Series and the
FINRA Rule 13000 Series.
    \16\ The term ``Director'' means the Director of the Office of
Dispute Resolution and includes FINRA staff to whom the Director has
delegated authority, unless the Code provides that the Director may
not delegate a specific function. See FINRA Rule 12100(m); see also
FINRA Rule 13100(m).
    \17\ See FINRA Rule 12500; see also FINRA Rule 13500.
    \18\ See FINRA Rule 12401; see also FINRA Rule 13401.
    \19\ See FINRA Rule 12501(a); see also FINRA Rule 13501(a).
---------------------------------------------------------------------------

    If more than one party cancels a prehearing conference under the
proposed rule, the arbitrators would have the authority to allocate the
fee in the award. The most common allocation would be between or among
the parties making the request. However, depending on the facts and
circumstances of the request, the arbitrators could assess the fee to
one party or to a non-requesting party or parties if the arbitrators
determine that these parties caused or contributed to the need for the
cancellation. This authority is granted to the arbitrators under the
Codes \20\ and is consistent with other fee provisions in the
Codes.\21\
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    \20\ See, e.g., FINRA Rules 12904(e)(8) and 13904(e)(8).
    \21\ See generally FINRA Rules 12601(b) and 13601(b).
---------------------------------------------------------------------------

    If an extraordinary circumstance prevents a party from making a
timely cancellation request, the arbitrators have the discretion to
waive the late cancellation fee, provided they receive a written
explanation of the circumstance. FINRA would notify parties and
arbitrators that the prehearing conference was cancelled and remind
parties to provide an explanation, if applicable, before the close of
the arbitration case. If the fee is waived, the party's or parties'
obligation to pay the fee would be eliminated. FINRA, however, would
pay the $100 per-arbitrator honorarium to the arbitrator(s) scheduled
to attend the prehearing conference.
    The following example illustrates how the rule would work. A
claimant files a claim for $150,000 against a firm. The parties select
their arbitrators, the panel is appointed, the Director schedules an
IPHC for Wednesday, August 15, 2018, and the three arbitrators are
scheduled to attend. The parties meet independently and finish
addressing the preliminary matters a week before the IPHC is scheduled.
If the parties notify the Director of their agreement to cancel the
IPHC \22\ on Thursday, August 9, 2018, they would

not be charged because they provided notice four business days before
the scheduled prehearing conference.\23\ If the parties notify the
Director of the cancellation on Friday, August 10, 2018, they would be
assessed a $100 per-arbitrator fee (or $300), because they would have
provided the cancellation notice within three business days before the
scheduled prehearing conference. In the example, if one party requested
cancellation of the IPHC by August 10 but an extraordinary circumstance
(e.g., a serious car accident) prevented timely notice, the party could
provide a written explanation before the case closes for the
arbitrators to consider waiving the fee. If the arbitrators waive the
fee, FINRA would still pay the $100 per-arbitrator honorarium to those
arbitrators scheduled to attend the conference.
---------------------------------------------------------------------------

    \22\ Parties may agree to forego the IPHC provided certain
conditions are met. See FINRA Rule 12500(c); see also FINRA Rule
13500(c).
    \23\ If August 9, 2018 were a FINRA holiday, the deadline would
be extended until the next business day. See FINRA Rule 12100(l);
see also FINRA Rule 13100(l). In this scenario, therefore, if the
latest date to avoid a fee falls on a holiday, parties would not be
assessed the late cancellation fee if they notify FINRA on the next
business day following the holiday.
---------------------------------------------------------------------------

    Finally, FINRA recognizes that customers could experience an
increase in costs under the proposed rule change if they are assessed a
part of or the entire late cancellation fee. FINRA notes that there are
some mitigation strategies that parties could employ to avoid incurring
these fees. As the objective of the proposed rule change is to
encourage parties to address preliminary matters further in advance of
a prehearing conference; if they do so, then they could provide notice
of cancellation more than three business days prior to the scheduled
prehearing conference to avoid the fee entirely. Further, if the
parties agree to cancel a scheduled prehearing conference three
business days or fewer before the scheduled conference, they can
negotiate responsibility for the fee. In addition, the rules permit the
arbitrator or panel to allocate the fee to the non-requesting party or
parties if the arbitrator(s) determine that the non-requesting party or
parties caused or contributed to the need for the cancellation.

Arbitrator Honorarium for Late Cancellation of Prehearing Conferences

    The proposed rule change would pay arbitrators who were scheduled
to attend the prehearing conference that was cancelled an honorarium
for late cancellations of prehearing conferences by amending FINRA Rule
12214(a) \24\ to provide that FINRA would pay an honorarium of $100 to
each arbitrator scheduled to attend a prehearing conference that was
cancelled within three business days of the prehearing conference by
agreement of the parties or was requested by one or more parties within
three business days of the prehearing conference and granted.
---------------------------------------------------------------------------

    \24\ FINRA Rule 13214(a) would also be amended. See supra note
13.
---------------------------------------------------------------------------

    If the arbitrators waive the fee, the obligation to pay the fee
would be eliminated, but FINRA would still pay the $100 per-arbitrator
honorarium to the arbitrator(s) scheduled to attend the prehearing
conference.

Nonsubstantive Changes

    In addition to amending FINRA Rules 12500 and 12501 \25\ to
establish a per-arbitrator fee for late cancellations of prehearing
conferences and FINRA Rule 12214(a) \26\ to create a corresponding
honorarium, the proposed rule change would also make a few
nonsubstantive changes to these rules.
---------------------------------------------------------------------------

    \25\ See also FINRA Rules 13500 and 13501.
    \26\ See also FINRA Rule 13214(a).
---------------------------------------------------------------------------

    As noted in Item 2 of this filing, if the Commission approves the
proposed rule change, FINRA will announce the effective date of the
proposed rule change in a Regulatory Notice to be published no later
than 60 days following Commission approval. The effective date will be
no later than 30 days following publication of the Regulatory Notice
announcing Commission approval.
2. Statutory Basis
    FINRA believes that the proposed rule change is consistent with the
provisions of Section 15A(b)(6) of the Act,\27\ which requires, among
other things, that FINRA rules must be designed to prevent fraudulent
and manipulative acts and practices, to promote just and equitable
principles of trade, and, in general, to protect investors and the
public interest, and Section 15A(b)(5) of the Act,\28\ which requires,
among other things, that FINRA rules provide for the equitable
allocation of reasonable dues, fees and other charges among members and
issuers and other persons using any facility or system that FINRA
operates or controls.
---------------------------------------------------------------------------

    \27\ 15 U.S.C. 78o-3(b)(6).
    \28\ 15 U.S.C. 78o-3(b)(5).
---------------------------------------------------------------------------

    FINRA believes that the proposed rule change would allocate
equitably the proposed late cancellation fee among those parties that
cancel such conferences on short notice. The proposed fee would be paid
by the parties, and passed through to the arbitrators to provide them
with some compensation for the preparation time expended and for their
inconvenience when a prehearing conference is cancelled on short
notice. While arbitrators would typically allocate the fee to the
requesting party or parties, FINRA rules permit the arbitrators to
allocate all, or a portion of the fee, to the non-requesting party or
parties if the arbitrators determine that the non-requesting party
caused or contributed to the late cancellation. Moreover, the fee can
be avoided altogether if the parties provide three business days'
notice of such a cancellation. For these reasons, FINRA believes that
the proposed fee is an equitable allocation of a reasonable fee to use
the forum.
    Moreover, FINRA believes that the proposed rule change would
protect investors and the public interest by improving FINRA's ability
to retain qualified arbitrators willing to devote the time and effort
necessary to consider thoroughly all prehearing issues presented, which
is an essential element for FINRA to operate an effective arbitration
forum for the purposes of investor protection and market integrity.

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

    FINRA does not believe that the proposed rule change will result in
any burden on competition that is not necessary or appropriate in
furtherance of the purposes of the Act. A discussion of the economic
impacts of the proposed amendments follows.
(a) Need for the Rule
    Unlike hearing sessions, parties can currently cancel prehearing
conferences up to and including the same day of the conference without
penalty.\29\ Late cancellations of prehearing conferences are costly to
arbitrators and can negatively impact their incentive to participate in
the forum. They also pose an operational challenge for FINRA staff. The
proposal would create incentives for parties to address preliminary
matters further in advance of a prehearing conference by charging a
late cancellation fee. The proposal would also compensate arbitrators
for their costs in the event of a late cancellation.
---------------------------------------------------------------------------

    \29\ Unless otherwise noted, consistent with the rest of the
document, references to cancellations include postponements.
---------------------------------------------------------------------------

(b) Economic Baseline
    The economic baseline for the proposal is the current rules under
the Codes that address the postponements and cancellations of hearings.
The proposal is expected to affect the parties to an arbitration
including customers, member firms, and associated persons.

The proposal is also expected to affect FINRA arbitrators.
    Arbitrators often spend considerable time and effort preparing for
prehearing conferences. Currently, parties that cancel a prehearing
conference do not incur a penalty, and arbitrators do not receive
compensation for their time and effort spent preparing if a prehearing
conference is cancelled (and not postponed until a later date). Late
cancellations of prehearing conferences can also result in scheduling
inconveniences. These factors can reduce the incentives of arbitrators
to participate in the forum and the ability of FINRA to retain
experienced arbitrators on the roster.\30\ The loss of experienced
arbitrators reduces the efficacy of the forum and the protections it
affords to investors and other industry participants from wrongdoing.
---------------------------------------------------------------------------

    \30\ See supra note 12.
---------------------------------------------------------------------------

    FINRA has collected information detailing the frequency of late
cancellations of prehearing conferences, from January 2018 to March
2018. FINRA is able to identify 182 instances of late cancellations of
prehearing conferences, or approximately ten percent of the 1,904
scheduled prehearing conferences. Among these late cancelations, there
were 474 arbitrators that could have been affected. This sample, from
one calendar quarter, suggests that late cancellations of prehearing
conferences could affect approximately one-quarter of arbitrators
annually.\31\
---------------------------------------------------------------------------

    \31\ There were a total of 7,364 registered FINRA arbitrators as
of January 2018.
---------------------------------------------------------------------------

(c) Economic Impact
    The proposal would charge parties a fee if a prehearing conference
is cancelled within three business days. A benefit of the proposal is
an increase in the incentives of arbitrators to participate in the
forum. Arbitrators would receive at least nominal compensation for
their time and effort preparing for a prehearing conference, and in
particular when the cancellation is closer to the conference date and
arbitrators have likely spent more time and effort to prepare.
Arbitrators would also be less likely to experience scheduling
inconveniences if the fee deters late cancellations of prehearing
conferences. The removal of a disincentive for arbitrators to
participate in the forum would reduce the likelihood that they resign
from the forum. Retaining more experienced arbitrators could improve
the efficacy of the forum and increase the protections it affords.
    Parties would incur a $100 fee for each arbitrator scheduled to
attend a prehearing conference in the event of a late cancellation.\32\
The late cancellation fee would increase the forum costs of parties
that cancel a prehearing conference or that are responsible for the
cancellation. FINRA does not expect, however, that the late
cancellation fee would reduce the incentives of parties to file claims.
The fee should encourage parties to be more effective in managing their
schedules and calendars to avoid late cancellations and to provide
appropriate notice when seeking to cancel prehearing conferences.
Arbitrators also have discretion to waive the late cancellation fee in
the event of an extraordinary circumstance provided that the parties
give a written explanation.
---------------------------------------------------------------------------

    \32\ FINRA believes that the amount of the honorarium is
reasonable given its understanding of the time and effort
arbitrators expend when preparing for prehearing conferences.
---------------------------------------------------------------------------

    Parties would be able to cancel a prehearing without penalty if the
cancellation is more than three business days in advance. In the event
that a prehearing conference is cancelled more than three business days
in advance, arbitrators would not receive compensation for any time and
effort in their preparation. FINRA believes, however, that arbitrators
are likely to put in more time and effort to prepare for a prehearing
conference closer to the scheduled date. Earlier cancellations,
therefore, are less likely to result in costs to the arbitrators and,
therefore, would lessen the negative impact on the incentives to
participate in the forum.
(d) Alternatives Considered
    Alternatives to the proposed amendments include applying the same
parameters as scheduled hearing sessions to prehearing conferences: The
number of days (10) prior to a scheduled hearing session for parties to
cancel without incurring a late cancellation fee and the fee amount
($600 per arbitrator) if parties cancel late. FINRA believes that
arbitrators' costs for a late cancellation are less for a prehearing
conference, which is often by phone, than for a scheduled hearing
session, which is typically in person. Accordingly, FINRA believes that
less advance notice and a lower fee are appropriate for cancellation of
a prehearing conference. FINRA believes that the proposed amendments
would incentivize parties to avoid late cancellations, while at the
same time compensating arbitrators in the event of a late cancellation
that is commensurate with their costs.

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

    Written comments were neither solicited nor received.

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

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

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to [email protected]. Please include
File Number SR-FINRA-2018-019 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-FINRA-2018-019. 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 such filing also will be available
for inspection and copying at the principal office of FINRA. 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-FINRA-2018-019 and should be
submitted on or before June 8, 2018.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\33\
---------------------------------------------------------------------------

    \33\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Eduardo A. Aleman,
Assistant Secretary.
[FR Doc. 2018-10603 Filed 5-17-18; 8:45 am]
 BILLING CODE 8011-01-P