[Federal Register Volume 79, Number 145 (Tuesday, July 29, 2014)]
[Notices]
[Pages 44021-44022]
[FR Doc No: 2014-17811]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings 1

    Take notice that the Commission received the following electric
corporate filings:
    Docket Numbers: EC14-114-000.
    Applicants: Gila River Power LLC, Union Power Partners, L.P.,
Entegra Power Services LLC, Wayzata Investment Partners LLC, Luminus
Management, LLC.
    Description: Errata to July 18, 2014 Joint Application for
Authorization Under Section 203 of Gila River Power LLC, et al.
    Filed Date: 7/21/14.
    Accession Number: 20140721-5157.
    Comments Due: 5 p.m. ET 8/8/14.
    Take notice that the Commission received the following electric
rate filings:
    Docket Numbers: ER10-2253-011; ER10-3319-014.
    Applicants: Astoria Energy LLC, Astoria Energy II LLC.
    Description: Supplement to June 30, 2014 Order No. 697 Triennial
Compliance Filing of Astoria Energy LLC and Astoria Energy II, LLC.
    Filed Date: 7/16/14.
    Accession Number: 20140716-5185.
    Comments Due: 5 p.m. ET 8/6/14.

    Docket Numbers: ER13-2452-002.
    Applicants: California Independent System Operator Corporation.
    Description: 2014-07-21--RIMPR1--SecondCompliance to be effective
N/A.
    Filed Date: 7/21/14.
    Accession Number: 20140721-5112.
    Comments Due: 5 p.m. ET 8/11/14.

    Docket Numbers: ER14-486-002.
    Applicants: UNS Electric, Inc.
    Description: UNSE Order No. 784 Correction Filing 2 to be effective
1/27/2014.
    Filed Date: 7/22/14.
    Accession Number: 20140722-5074.
    Comments Due: 5 p.m. ET 8/12/14.

    Docket Numbers: ER14-2455-001.
    Applicants: Hawks Nest Hydro LLC.
    Description: Hawks Nest Hydro Amended Filing to be effective 7/23/
2014.
    Filed Date: 7/22/14.
    Accession Number: 20140722-5051.
    Comments Due: 5 p.m. ET 8/12/14.

    Docket Numbers: ER14-2471-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: Revisions to OATT Att K Sec 3.2 and OA Sch 1 Sec 3.2--
Shoulder Hour Opp Cost to be effective 9/22/2014.
    Filed Date: 7/21/14.
    Accession Number: 20140721-5111.
    Comments Due: 5 p.m. ET 8/11/14.

    Docket Numbers: ER14-2472-000.
    Applicants: Agera Energy LLC.
    Description: Baseline new to be effective 7/23/2014.
    Filed Date: 7/21/14.
    Accession Number: 20140721-5122.
    Comments Due: 5 p.m. ET 8/11/14.

    Docket Numbers: ER14-2473-000.
    Applicants: Duke Energy Carolinas, LLC.
    Description: Cancellation of Rate Schedule 342 Cargill-DEC to be
effective 9/22/2014.
    Filed Date: 7/22/14.
    Accession Number: 20140722-5025.
    Comments Due: 5 p.m. ET 8/12/14.

    Docket Numbers: ER14-2474-000.
    Applicants: CleanLight Power + Energy, LLC, Gloucester Solar Farm,
LLC.
    Description: Request for Waiver of CleanLight Power + Energy, LLC,
et. al.
    Filed Date: 7/22/14.
    Accession Number: 20140722-5060.
    Comments Due: 5 p.m. ET 8/12/14.

    Docket Numbers: ER14-2475-000.
    Applicants: AEP Texas North Company.
    Description: CSW Operating Companies MBR Concurrence ER14-869 to be
effective 7/25/2014.
    Filed Date: 7/22/14.
    Accession Number: 20140722-5075.
    Comments Due: 5 p.m. ET 8/12/14.

    Docket Numbers: ER14-2476-000.
    Applicants: Public Service Company of Oklahoma.
    Description: CSW Operating Companies MBR Concurrence ER14-869 to be
effective 7/25/2014.
    Filed Date: 7/22/14.
    Accession Number: 20140722-5076.
    Comments Due: 5 p.m. ET 8/12/14.

    Docket Numbers: ER14-2477-000.
    Applicants: Southwestern Electric Power Company.
    Description: CSW Operating Companies MBR Concurrence ER14-869 to be
effective 7/25/2014.
    Filed Date: 7/22/14.
    Accession Number: 20140722-5077.
    Comments Due: 5 p.m. ET 8/12/14.
    Take notice that the Commission received the following electric
securities filings:
    Docket Numbers: ES14-45-000.
    Applicants: Northern Pass Transmission LLC.
    Description: Amendment to July 2, 2014 Application for Authority to
Issue Debt Securities of Northern Pass Transmission LLC.
    Filed Date: 7/22/14.
    Accession Number: 20140722-5018.
    Comments Due: 5 p.m. ET 8/1/14.
    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: July 22, 2014.
Nathaniel J. Davis, Sr.,
Deputy Secretary..
[FR Doc. 2014-17811 Filed 7-28-14; 8:45 am].
BILLING CODE 6717-01-P


[Federal Register Volume 85, Number 189 (Tuesday, September 29, 2020)]
[Notices]
[Pages 61009-61011]
[FR Doc No: 2020-21461]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-1790]

M7 Assessment and Control of Deoxyribonucleic Acid Reactive
(Mutagenic) Impurities in Pharmaceuticals To Limit Potential
Carcinogenic Risk--Questions and Answers; International Council for
Harmonisation; Draft Guidance for Industry; 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 a draft guidance for industry entitled ``M7
Assessment and Control of DNA Reactive (Mutagenic) Impurities in
Pharmaceuticals To Limit Potential Carcinogenic Risk--Questions and
Answers.'' The draft guidance was prepared under the auspices of the
International Council for Harmonisation of Technical Requirements for
Pharmaceuticals for Human Use (ICH), formerly the International
Conference on Harmonisation of Technical Requirements for Registration
of Pharmaceuticals for Human Use. The draft guidance provides a
practical approach that is applicable to the identification,
categorization, qualification, and control of mutagenic impurities to
limit potential carcinogenic risk. Since the ICH M7 Guideline was
finalized, the worldwide experience with implementation of the
recommendations for DNA reactive (mutagenic) impurities has given rise
to requests for clarification relating to the assessment and control of
DNA reactive (mutagenic) impurities. To facilitate the implementation
of the ICH M7 Guideline, the ICH M7 Implementation Working Group has
developed a series of questions and answers (Q&As). The scope of this
draft Q&A guidance follows that of the ICH M7 Guideline. The draft Q&A
guidance is intended to clarify, promote the convergence of, and
improve the harmonization of the considerations for assessment and
control of DNA reactive (mutagenic) impurities and of the information
that should be provided when developing

drugs, completing marketing authorization applications, and using drug
master files.

DATES: Submit either electronic or written comments on the draft
guidance by December 28, 2020 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-2020-N-1790 for ``M7 Assessment and Control of DNA Reactive
(Mutagenic) Impurities in Pharmaceuticals to Limit Potential
Carcinogenic Risk--Questions and Answers.'' 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)).
    Submit written requests for single copies of this guidance to the
Division of Drug Information, Center for Drug Evaluation and Research,
Food and Drug Administration, 10001 New Hampshire Ave., Hillandale
Building, 4th Floor, 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 requests. The guidance may also be obtained by mail by calling
CBER at 1-800-835-4709 or<PHONE_NUMBER>. See the SUPPLEMENTARY
INFORMATION section for electronic access to the guidance document.

FOR FURTHER INFORMATION CONTACT:
    Regarding the guidance: Aisar Atrakchi, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 22, Rm. 4118, Silver Spring, MD 20993-0002,<PHONE_NUMBER>; or
Stephen Ripley, Center for Biologics Evaluation and Research, Food and
Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301,
Silver Spring, MD 20993-0002,<PHONE_NUMBER>.
    Regarding the ICH: Jill Adleberg, Center for Drug Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, Rm. 6364, Silver Spring, MD 20993-0002,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``M7 Assessment and Control of DNA Reactive (Mutagenic)
Impurities in Pharmaceuticals To Limit Potential Carcinogenic Risk--
Questions and Answers.'' The draft guidance was prepared under the
auspices of ICH. ICH has the mission of achieving greater regulatory
harmonization worldwide to ensure that safe, effective, high-quality
medicines are developed, registered, and maintained in the most
resource-efficient manner.
    By harmonizing the regulatory requirements in regions around the
world, ICH guidelines have substantially reduced duplicative clinical
studies, prevented unnecessary animal studies, standardized the
reporting of important safety information, standardized marketing
application submissions, and made many other improvements in the
quality of global drug development and manufacturing and the products
available to patients.
    The six Founding Members of the ICH are FDA; the Pharmaceutical
Research and Manufacturers of America; the European Commission; the
European Federation of Pharmaceutical Industries Associations; the
Japanese Ministry of Health, Labour, and Welfare; and the Japanese
Pharmaceutical Manufacturers Association. The Standing Members of the
ICH Association include Health Canada and Swissmedic. Additionally,

the Membership of ICH has expanded to include other regulatory
authorities and industry associations from around the world (https://www.ich.org/).
    ICH works by involving technical experts from both regulators and
industry parties in detailed technical harmonization work and the
application of a science-based approach to harmonization through a
consensus-driven process that results in the development of ICH
guidelines. The regulators around the world are committed to
consistently adopting these consensus-based guidelines, realizing the
benefits for patients and for industry.
    As a Founding Regulatory Member of ICH, FDA plays a major role in
the development of each of the ICH guidelines, which FDA then adopts
and issues as guidance for industry. FDA's guidance documents do not
establish legally enforceable responsibilities. Instead, they describe
the Agency's current thinking on a topic and should be viewed only as
recommendations, unless specific regulatory or statutory requirements
are cited.
    In June 2020, the ICH Assembly endorsed the draft guideline
entitled ``M7 Assessment and Control of DNA Reactive (Mutagenic)
Impurities in Pharmaceuticals To Limit Potential Carcinogenic Risk--
Questions and Answers'' and agreed that the guideline should be made
available for public comment. The draft guideline is the product of the
Safety Expert Working Group of the ICH. Comments about this draft will
be considered by FDA and the Safety Expert Working Group.
    The draft Q&A guidance is intended to clarify, promote the
convergence of, and improve the harmonization of the considerations for
assessment and control of DNA reactive (mutagenic) impurities and of
the information that should be provided when developing drugs,
completing marketing authorization applications, and using drug master
files. This is important because since the ICH M7 Guideline was
finalized, the worldwide experience with implementation of the
recommendations for DNA reactive (mutagenic) impurities has given rise
to requests for clarification relating to the assessment and control of
DNA reactive (mutagenic) impurities. To facilitate the implementation
of the ICH M7 Guideline, the ICH M7 Implementation Working Group has
developed a series of Q&As. The scope of this draft Q&A guidance
follows that of the ICH M7 Guideline.
    This draft guidance has been left in the original ICH format. The
final guidance will be reformatted and edited to conform with FDA's
good guidance practices regulation (21 CFR 10.115) and style before
publication. The draft guidance, when finalized, will represent the
current thinking of FDA on ``M7 Assessment and Control of DNA Reactive
(Mutagenic) Impurities in Pharmaceuticals To Limit Potential
Carcinogenic Risk--Questions and Answers.'' 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. Paperwork Reduction Act of 1995

    FDA tentatively concludes that this draft guidance contains no
collection 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.
    However, this draft guidance refers to previously approved FDA
collections of information. These collections of information are
subject to review by OMB under the PRA. The collections of information
in 21 CFR part 601 has been approved under OMB control number 0910-
0338. The collections of information in 21 CFR parts 312 and 314 have
been approved under OMB control numbers 0910-0014 and 0910-0001, and
the collection of information under 21 CFR parts 210 and 211 have been
approved under OMB control number 0910-0139.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance
at https://www.regulations.gov, https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, or https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances.

    Dated: September 22, 2020.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2020-21461 Filed 9-28-20; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 83, Number 104 (Wednesday, May 30, 2018)]
[Notices]
[Pages 24832-24834]
[FR Doc No: 2018-11500]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-83310; File No. SR-BOX-2018-16]

Self-Regulatory Organizations; BOX Options Exchange LLC; Notice
of Filing and Immediate Effectiveness of a Proposed Rule Change To
Amend the Fee Schedule on the BOX Market LLC (``BOX'') Options Facility
To Amend SAIL Port Fees

May 23, 2018.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(the ``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that on May 11, 2018, BOX Options Exchange LLC (the ``Exchange'') filed
with the Securities and Exchange Commission

(``Commission'') the proposed rule change as described in Items I, II,
and III below, which Items have been prepared by the Exchange. The
Exchange filed the proposed rule change pursuant to Section
19(b)(3)(A)(ii) of the Act,\3\ and Rule 19b-4(f)(2) thereunder,\4\
which renders the proposal effective upon filing with the Commission.
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.
    \3\ 15 U.S.C. 78s(b)(3)(A)(ii).
    \4\ 17 CFR 240.19b-4(f)(2).
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I. Self-Regulatory Organization's Statement of the Terms of the
Substance of the Proposed Rule Change

    The Exchange is filing with the Securities and Exchange Commission
(``Commission'') a proposed rule change to amend the Fee Schedule to on
[sic] the BOX Market LLC (``BOX'') options facility. The text of the
proposed rule change is available from the principal office of the
Exchange, at the Commission's Public Reference Room and also on the
Exchange's internet website at http://boxexchange.com.

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

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

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

1. Purpose
    The Exchange proposes to amend Section VI.B (Port Fees) of the BOX
Fee Schedule. Specifically, the Exchange proposes to amend the
SOLA[supreg] Access Information Language (``SAIL'') Port Fees on the
Exchange. Currently, Market Makers are assessed a monthly fee of $1,000
for all Ports. The Exchange proposes to rename the ``Market Maker''
Port to ``Market Making'' Port. The Exchange notes that the monthly
$1000 flat fee will remain for all Market Making Ports \5\ on the
Exchange. Additionally, the Exchange proposes to rename ``Other
Participants'' to ``Order Entry.'' With this change, all SAIL Ports
used solely for order entry purposes will be charged $500 per month per
Port for Ports 1-5 and $150 per month per additional Port, regardless
of account type.
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    \5\ While Market Makers on BOX currently connect to at least 16
SAIL Market Making Ports to satisfy their quoting requirements, the
Exchange notes that the total number of SAIL Market Making Ports
used varies based on the Market Maker. The Exchange believes that
charging a flat fee for all market making Ports is reasonable and
appropriate as the Exchange does not want to disincentivize Market
Makers from quoting on BOX, regardless of how many Market Making
Ports the Market Makers use.
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2. Statutory Basis
    The Exchange believes that the proposal is consistent with the
requirements of Section 6(b) of the Act, in general, and Section
6(b)(4) and 6(b)(5)of the Act,\6\ in particular, in that it provides
for the equitable allocation of reasonable dues, fees, and other
charges among BOX Participants and other persons using its facilities
and does not unfairly discriminate between customers, issuers, brokers
or dealers.
---------------------------------------------------------------------------

    \6\ 15 U.S.C. 78f(b)(4) and (5).
---------------------------------------------------------------------------

    The Exchange believes that the proposed changes are reasonable,
equitable and not unfairly discriminatory. The Exchange recently
established Port Fees for Participants. BOX Market Makers currently
connect to a minimum of sixteen (16) SAIL Ports and pay a flat monthly
fee for these connections.\7\ The Exchange now proposes to clarify that
the current flat fee of $1,000 per month is for Ports used for market
making purposes (i.e. quoting) only. As discussed above, the number of
SAIL Port connections for market making purposes vary based on the
Market Maker. The Exchange recognizes that the various BOX Market
Makers may not need the same number of SAIL Port connections due to
different technology architecture and trading systems. As such, the
Exchange proposes the current flat fee of $1,000 for all Marketing
Making SAIL Ports as to not disincentivize Market Makers from quoting
on BOX.
---------------------------------------------------------------------------

    \7\ See SR-BOX-2018-15.
---------------------------------------------------------------------------

    Further, the Exchange proposes to rename the ``Other Participants''
Port to ``Order Entry'' Port. The Exchange believes that this change
provides clarity with respect to the types of SAIL Ports in use. With
this change, all Participants will be charged $500 per month per Port
for Ports 1-5 and $150 per month per additional Port. The Exchange
believes that this proposed change is equitable and not unfairly
discriminatory as the Order Entry Port fees are assessed to all
Participants that use SAIL for order entry on BOX, regardless of
account type. Lastly, the Exchange believes that the proposed change is
reasonable and appropriate as other exchanges in the industry assess
market making port fees separate from order entry port fees.\8\
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    \8\ See Miami International Securities Exchange LLC (``MIAX'')
Fee Schedule. MIAX charges its Market Makers monthly MEI Port Fees
based on Market Maker Class Assignment. Additionally, they assess
all Members (Market Makers included) FIX Port fees which allows such
Members to enter orders on the exchange. Members are assessed $550
per month for the 1st FIX Port, $350 per month per Port for FIX
Ports 2 through 5 and $150 per month per Port for additional FIX
Ports over 5. See also Nasdaq Options Market (``NOM'') Fee Schedule.
NOM also charges its Market Makers monthly Quote Port Fees based on
number of Ports. They also assess an Order Entry Port Fee of $650
per month per mnemonic that Market Makers may also use if entering
orders on the Exchange. BOX notes that the SAIL Port is slightly
different than the above ports, as both Market Makers and other BOX
Participants may connect through the SAIL Port to enter orders on
the Exchange.
---------------------------------------------------------------------------

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

    The Exchange does not believe that the proposed rule change will
impose any burden on competition not necessary or appropriate in
furtherance of the purposes of the Act. Unilateral action by BOX in
establishing fees for services provided to its Participants and others
using its facilities will not have an impact on competition. As a small
Exchange in the already highly competitive environment for options
trading, BOX does not have the market power necessary to set prices for
services that are unreasonable or unfairly discriminatory in violation
of the Exchange Act. BOX's proposed fees, as described herein, are
comparable to and generally lower than fees charged by other options
exchanges for the same or similar services. Lastly, the Exchange
believes the proposed change will not impose a burden on intramarket
competition as the proposed fees are applicable to all Participants who
connect to BOX.

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

    No written comments were either solicited or received.

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

    The foregoing rule change has become effective pursuant to Section
19(b)(3)(A)(ii) of the Exchange Act \9\ and

Rule 19b-4(f)(2) thereunder,\10\ because it establishes or changes a
due, or fee.
---------------------------------------------------------------------------

    \9\ 15 U.S.C. 78s(b)(3)(A)(ii).
    \10\ 17 CFR 240.19b-4(f)(2).
---------------------------------------------------------------------------

    At any time within 60 days of the filing of the proposed rule
change, the Commission summarily may temporarily suspend the rule
change if it appears to the Commission that the action is necessary or
appropriate in the public interest, for the protection of investors, or
would otherwise further the purposes of the Act. If the Commission
takes such action, the Commission shall institute proceedings to
determine whether the proposed rule should be approved or disapproved.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to [email protected]. Please include
File Number SR-BOX-2018-16 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-BOX-2018-16. 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 the Exchange. All comments
received will be posted without change. Persons submitting comments are
cautioned that we do not redact or edit personal identifying
information from comment submissions. You should submit only
information that you wish to make available publicly. All submissions
should refer to File Number SR-BOX-2018-16, and should be submitted on
or before June 20, 2018.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\11\
---------------------------------------------------------------------------

    \11\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Brent J. Fields,
Secretary.
[FR Doc. 2018-11500 Filed 5-29-18; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 87, Number 189 (Friday, September 30, 2022)]
[Rules and Regulations]
[Pages 59302-59304]
[FR Doc No: 2022-21204]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket Number USCG-2022-0828]
RIN 1625-AA00

Safety Zone; Mutiny Bay, Whidbey Island, WA

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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SUMMARY: The Coast Guard is establishing a temporary safety zone for
navigable waters of Mutiny Bay, Whidbey Island, Washington. The
temporary safety zone encompasses all waters within a 1000-yard radius
of a barge anchored in Mutiny Bay. The safety zone is needed to protect
personnel, vessels, and the marine environment from potential hazards
associate with operations to recover a downed aircraft in this area.
Entry of vessels or persons into this zone is prohibited unless
specifically authorized by the Captain of the Port Puget Sound (COTP).

DATES: This rule is effective without actual notice from September 30,
2022 through 10 p.m. October 5, 2022. For the purposes of enforcement,
actual notice will be used from 1 a.m. September 26, 2022 until
September 30, 2022.

ADDRESSES: To view documents mentioned in this preamble as being
available in the docket, go to https://www.regulations.gov, type USCG-
2022-0828 in the search box and click ``Search.'' Next, in the Document
Type column, select ``Supporting & Related Material.''

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or email Chief Warrant Officer William E. Martinez, Sector Puget
Sound, Waterways Management Division, U.S. Coast Guard; telephone 206-
217-6051, email [email protected].

SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

CFR Code of Federal Regulations
COTP Captain of the Port Puget Sound
DHS Department of Homeland Security
FR Federal Register
NPRM Notice of proposed rulemaking
Sec.  Section
U.S.C. United States Code

II. Background Information and Regulatory History

    The Coast Guard is issuing this temporary rule without prior notice
and opportunity to comment pursuant to authority under section 4(a) of
the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This
provision authorizes an agency to issue a rule without prior notice and
opportunity to comment when the agency for good cause finds that those
procedures are ``impracticable, unnecessary, or contrary to the public
interest.'' Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good
cause exists for not publishing a notice of proposed rulemaking (NPRM)
with respect to this rule because the Coast Guard was notified of the
planned salvage operation on September 16, 2022 and immediate action is
needed to respond to the potential safety hazards associated with the
recovery of the downed aircraft. It is impracticable to publish an NPRM
because we must establish this safety zone by the start of recovery
operations on September 26, 2022.
    Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause
exists for making this rule effective less than 30 days after
publication in the Federal Register. Delaying the effective date of
this rule would be impracticable because immediate action is needed to
respond to the potential safety hazards associated with the salvage
operations.

III. Legal Authority and Need for Rule

    The Coast Guard is issuing this rule under authority in 46 U.S.C.
70034 (previously 33 U.S.C. 1231). The COTP

has determined that potential hazards associated with salvage
operations starting September 26, 2022 will be a safety concern for
anyone within a 1000-yard radius of the barge anchored in Mutiny Bay,
Whidbey Island. This rule is needed to protect personnel, vessels, and
the marine environment in the navigable waters within the safety zone
during ongoing salvage operations.

IV. Discussion of the Rule

    This rule establishes a safety zone from 1 a.m. on September 26,
2022 until 10 p.m. October 5, 2022. The safety zone will cover all
navigable waters from surface to the bottom within a 1000-yard radius
of the barge anchored in position 47[deg]59'25.994'' N
122[deg]35'06.817'' W in Mutiny Bay, Whidbey Island, Washington. The
duration of the zone is intended to protect personnel, vessels, and the
marine environment in these navigable waters during salvage operations
of a downed aircraft. No vessel or person will be permitted to enter
the safety zone without obtaining permission from the COTP or a
designated representative. The safety zone may be suspended early at
the discretion of the COTP .

V. Regulatory Analyses

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

A. Regulatory Planning and Review

    Executive Orders 12866 and 13563 direct agencies to assess the
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits. This rule has not been designated a ``significant
regulatory action,'' under Executive Order 12866. Accordingly, this
rule has not been reviewed by the Office of Management and Budget.
    This regulatory action determination is based on size, location,
duration, and time-of-day of the safety zone. Vessel traffic will be
able to safely transit around this safety zone which would impact a
small designated area of Mutiny Bay, Whidbey Island for a total of 10
days and operations may be suspended early at the discretion of the
COTP. Moreover, the Coast Guard will issue a Broadcast Notice to
Mariners via VHF-FM marine channel 16 about the zone.

B. Impact on Small Entities

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

C. Collection of Information

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

D. Federalism and Indian Tribal Governments

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

E. Unfunded Mandates Reform Act

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

F. Environment

    We have analyzed this rule under Department of Homeland Security
Directive 023-01, Rev. 1, associated implementing instructions, and
Environmental Planning COMDTINST 5090.1 (series), which guide the Coast
Guard in complying with the National Environmental Policy Act of 1969
(42 U.S.C. 4321-4370f), and have determined that this action is one of
a category of actions that do not individually or cumulatively have a
significant effect on the human environment. This rule involves a
safety zone with a duration of 10 days or until salvage operations are
completed. It is categorically excluded from further review under
paragraph L60(d) of Appendix A, Table 1 of DHS Instruction Manual 023-
01-001-01, Rev. 1. A Record of Environmental Consideration supporting
this determination will be produced. For instructions on locating the
docket, see the ADDRESSES section of this preamble.

G. Protest Activities

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

jeopardizing the safety or security of people, places or vessels.

List of Subjects in 33 CFR Part 165

    Harbors, Marine Safety, Navigation (water), Reporting and
recordkeeping requirements, Security measures, Waterways.

    For the reasons discussed in the preamble, the Coast Guard amends
33 CFR part 165 as follows:

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

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

    Authority:  46 U.S.C. 70034, 70051; 33 CFR 1.05-1, 6.04-1, 6.04-
6, and 160.5; Department of Homeland Security Delegation No.
00170.1, Revision No. 01.2.

0
2. Add Sec.  165.T13-0828 to read as follows:

Sec.  165.T13-0828  Safety Zone; Mutiny Bay, Whidbey Island, WA.

    (a) Location. The safety zone is located within the Captain of the
Port Puget Sound (COTP) zone (See 33 CFR 3.65-10) and will encompass
all navigable waters, from the surface to the bottom, within a 1000-
yard radius of a barge anchored in position 47[deg]59'25.994'' N
122[deg]35'06.817'' W in Mutiny Bay, Whidbey Island, WA. These
coordinates are based 1984 World Geodetic System (WGS 84).
    (b) Definitions. As used in this section, a designated
representative means a Coast Guard Patrol Commander, including a Coast
Guard coxswain, petty officer, or other officer operating a Coast Guard
vessel and any Federal, State, and local officers designated by or
assisting the COTP in the enforcement of the safety zone.
    (c) Regulations. (1) Under the general safety zone regulations in
subpart C of this part, you may not enter the safety zone described in
paragraph (a) of this section unless authorized by the COTP or the
COTP's designated representative.
    (2) To seek permission to enter, contact the COTP or the COTP's
representative by VHF Channel 16. Those in the safety zone must comply
with all lawful orders or directions given to them by the COTP or the
COTP's designated representative. If permission is granted, all persons
and vessels must comply with the instructions of the COTP or his
designated representative and proceed at the minimum speed necessary to
maintain a safe course while in the zone.
    (d) Enforcement period. This safety zone is in effect from 1 a.m.
on September 26, 2022 through 10 p.m. on October 5, 2022. It will be
subject to enforcement this entire period unless the COTP determines it
is no longer needed, in which case the Coast Guard will inform mariners
via Broadcast Notice to Mariners on VHF-FM marine channel 16.

    Dated: September 26, 2022.
P.M. Hilbert,
Captain, U.S. Coast Guard, Captain of the Port Puget Sound.
[FR Doc. 2022-21204 Filed 9-29-22; 8:45 am]
BILLING CODE 9110-04-P