[Federal Register Volume 83, Number 152 (Tuesday, August 7, 2018)]
[Notices]
[Pages 38699-38700]
[FR Doc No: 2018-16813]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-D-2382]

Opioid Use Disorder: Endpoints for Demonstrating Effectiveness of
Drugs for Medication-Assisted Treatment; Draft Guidance for Industry;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the availability of a draft guidance for industry entitled ``Opioid Use
Disorder: Endpoints for Demonstrating Effectiveness of Drugs for
Medication-Assisted Treatment.'' This guidance addresses the clinical
endpoints acceptable to demonstrate effectiveness of drugs for
medication-assisted treatment of opioid use disorder. FDA is also
requesting comments on when the use of placebo or active controls is
most appropriate in clinical trials for such drugs.

DATES: Submit either electronic or written comments on the draft
guidance by October 9, 2018 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final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-2018-D-2382 for ``Opioid Use Disorder: Endpoints for Demonstrating
Effectiveness of Drugs for Medication-Assisted Treatment.'' 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.
     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.gpo.gov/fdsys/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.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of the draft 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. Send one
self-addressed adhesive label to assist that office in processing your
requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Silvana Borges, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 3200,

Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``Opioid Use Disorder: Endpoints for Demonstrating
Effectiveness of Drugs for Medication-Assisted Treatment.'' This
guidance addresses the clinical endpoints acceptable to demonstrate
effectiveness of drugs for medication-assisted treatment of opioid use
disorder. FDA is also requesting comments on when the use of placebo or
active controls is most appropriate in clinical trials for such drugs.
    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 endpoints for
demonstrating effectiveness of drugs for medication-assisted treatment
of opioid use disorder. 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. This guidance is not subject to Executive Order 12866.

II. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of
information that are subject to review by the Office of Management and
Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3520). The collections of information in 21 CFR part 312 have been
approved under OMB control number 0910-0014.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance
at either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or
https://www.regulations.gov.

    Dated: August 1, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-16813 Filed 8-6-18; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 84, Number 43 (Tuesday, March 5, 2019)]
[Notices]
[Pages 7954-7957]
[FR Doc No: 2019-03891]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-85208; File No. SR-EMERALD-2019-05]

Self-Regulatory Organizations; MIAX Emerald, LLC; Notice of
Filing and Immediate Effectiveness of a Proposed Rule Change To Amend
Exchange Rule 602, Appointment of Market Makers

February 27, 2019.
    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 February 19, 2019, MIAX Emerald, LLC (``MIAX Emerald'' or
``Exchange'') filed with the Securities and Exchange Commission
(``Commission'') a proposed rule change as described in Items I and II
below, which Items have been prepared by the Exchange. The Commission
is publishing this notice to solicit comments on the proposed rule
change from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange is filing a proposal to amend Exchange Rule 602,
Appointment of Market Makers, in order to harmonize its rule to the
rules of the Exchange's affiliate, Miami International Securities
Exchange, LLC (``MIAX Options'').
    The text of the proposed rule change is available on the Exchange's
website at http://www.miaxoptions.com/rule-filings/emerald, at MIAX
Emerald's principal office, and at the Commission's Public Reference
Room.

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

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

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

1. Purpose
    The Exchange proposes to amend MIAX Emerald Rule 602, Appointment
of Market Makers, in order to harmonize its rule to the rules of MIAX
Options.
Background
    MIAX Emerald plans to commence operations as a national securities
exchange registered under Section 6 of the Act \3\ on March 1, 2019. As
described more fully in MIAX Emerald's Form 1 application,\4\ the
Exchange is an affiliate of MIAX Options and MIAX PEARL, LLC (``MIAX
PEARL''). MIAX Emerald Rules, in their current form, were filed as
Exhibit B to its Form 1 on August 16, 2018, and at that time, the above
mentioned rules, were substantially similar to the rules of the MIAX
Options exchange. In the time between when the Exchange filed its Form
1 and the time the Exchange received its approval order, MIAX Options
made changes to its rule book. In order to ensure consistent operation
of both MIAX Emerald and MIAX Options through having consistent rules,
the Exchange proposes to amend MIAX Emerald Rules as described below.
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    \3\ 15 U.S.C. 78f.
    \4\ See Securities Exchange Act Release No. 84891 (December 20,
2018), 83 FR 67421 (December 28, 2018) (File No. 10-233) (order
approving application of MIAX EMERALD, LLC for registration as a
national securities exchange).
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Proposal
    The Exchange proposes to amend MIAX Emerald Rule 602, Appointment
of Market Makers, to specify the method by which LMMs and RMMs would
request appointments to (and relinquishment of appointments from) one
or more classes of option contracts traded on the Exchange pursuant to
Rule 602(a). These changes would make MIAX Emerald Rule 602 consistent
with MIAX Options Rule 602 and are identical to changes made by MIAX
Options when it modified its rule.\5\ The Exchange believes this
proposal would harmonize the appointment process between MIAX Options
and MIAX Emerald, and would promote efficiency for both the Exchange
and for these types of Market Makers.\6\ Other option exchanges also
specify a method which governs the appointment of market makers to
classes of option contracts traded on the exchange, however, these
methods, while generally automated, differ somewhat across
exchanges.\7\
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    \5\ See Securities Exchange Act Release No. 83577 (July 2,
2018), 83 FR 31812 (July 9, 2018) (SR-MIAX-2018-13).
    \6\ The term ``Market Makers'' refers to ``Lead Market Makers,''
``Primary Lead Market Makers'' and ``Registered Market Makers''
collectively. See Exchange Rule 100.
    \7\ See, e.g., Cboe BZX Exchange, Inc. (``Cboe BZX'') Rules
22.3(a),(b) (Market Maker Registration); see also Nasdaq PHLX, LLC
(``Nasdaq Phlx'') Rule 3212(b) (Registration as a Market Maker);
Nasdaq Options Market (``NOM''), Chapter VII (Market Participants),
Section 3(a),(b) (Continuing Market Maker Registration); NYSE
American, LLC (``NYSE American''), Rule 923NY (Appointment of Market
Makers).
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    Once a Member \8\ has qualified as either an LMM or an RMM, such
Market Maker may request an appointment (or, following an appointment,
relinquishment from an appointment) in one or more option classes
pursuant to Rule 602. The Exchange's proposal seeks to specify that
LMMs and RMMs would be required to use an Exchange approved electronic
interface to request appointments (and relinquishment of appointments)
to one or more classes of option contracts. A Primary Lead

Market Maker (``PLMM''),\9\ however, would go through a different, more
extensive appointment process. Accordingly, the Exchange intentionally
excluded PLMMs from this proposal. The Exchange believes it is
appropriate to exclude PLMMs from this appointment method because the
Board or designated committee would appoint only one PLMM to each
options class traded on the Exchange, as opposed to the multiple number
of LMMs and RMMs, and because of the heightened obligations associated
with performing the responsibilities of a PLMM.\10\ Because of the
heightened responsibilities of PLMMs, the Exchange believes that it is
appropriate to have a different method for PLMMs on the one hand, and
LMMs and RMMs on the other hand, with respect to the method by which
appointments (and relinquishments of appointments) are requested.
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    \8\ The term ``Member'' means an individual or organization
approved to exercise the trading rights associated with a Trading
Permit. Members are deemed ``members'' under the Exchange Act. See
Exchange Rule 100.
    \9\ A ``Primary Lead Market Maker'' is a Lead Market Maker
appointment by the Exchange to act as the Primary Lead Market Maker
for the purpose of making markets in securities traded on the
Exchange. The Primary Lead Market Maker is vested with the rights
and responsibilities specified in Chapter VI of these Rules with
respect to Primary Lead Market Makers. See Exchange Rule 100.
    \10\ See, for example, Exchange Rules 603 and 604 for certain
heightened obligations of PLMMs.
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    Specifically, Rule 602(a) provides that ``[t]he Board or a
committee designated by the Board shall appoint Market Makers to one or
more classes of option contracts traded on the Exchange.'' \11\ In
addition to having the authority to appoint one PLMM to each options
class, ``[t]he Exchange will impose an upper limit on the aggregate
number of Market Makers that may quote in each class of options
(``Class Quoting Limit'' or ``CQL'').'' Currently, the CQL is set at
fifty (50) Market Makers per option class but the Exchange may
``increase the CQL for an existing or new option class if the President
determines that it would be appropriate.'' \12\ Further, Rule 602(c)(2)
provides that ``Market Makers requesting an appointment in a class of
options will be considered for the appointment in accordance with
paragraphs (a), (b) and (f) of this Rule 602, provided the number of
Market Makers appointed in the options class does not exceed the CQL.''
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    \11\ See Rule 602(a).
    \12\ See Rule 602(c).
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    In making appointments of Market Makers to one or more classes of
option contracts traded on the Exchange, the Board or designated
committee shall consider the financial resources available to the
Market Maker; the Market Maker's experience and expertise in market
making or options trading; the preferences of the Market Maker to
receive appointment(s) in specific option class(es); and the
maintenance and enhancement of competition among Market Makers in each
class of option contracts to which they are appointed.\13\ Rule
602(c)(2) also states that, when the number of Market Makers appointed
in the options class equals the CQL, all other Market Makers requesting
to be appointed in that options class will be wait-listed in the order
in which they submitted their request.\14\
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    \13\ See Rule 602(a).
    \14\ See Rule 602(c)(2).
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    Under the current Rule, ``[t]he Board or designated committee may
suspend or terminate any appointment of a Market Maker under this Rule
[602] and may make additional appointments or change the option classes
included in a Market Maker's appointed classes whenever, in the Board's
or designated committee's judgment, the interests of a fair and orderly
market are best served by such action.'' \15\ Moreover, the Exchange
``shall periodically conduct an evaluation of Market Makers to
determine whether they have fulfilled performance standards relating
to, among other things, quality of markets, competition among Market
Makers, observance of ethical standards, and administrative factors.
The Exchange may consider any relevant information, including but not
limited to the results of a Market Maker evaluation questionnaire,
trading data, a Market Maker's regulatory history and such other
factors and data as may be pertinent in the circumstances.'' \16\ If
the Exchange finds that a Market Maker has not met the performance
standards, the Exchange may take action, including suspending,
terminating or restricting a Market Maker's appointment or
registration.\17\
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    \15\ See Rule 602(e).
    \16\ See Rule 602(f).
    \17\ See id.
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    The Exchange proposes to amend MIAX Emerald Rule 602 solely to
specify the method by which LMMs and RMMs would request appointments to
(or relinquishment of appointments from) one or more classes of option
contracts traded on the Exchange pursuant to Rule 602(a). In
particular, the Exchange proposes to adopt Interpretations & Policies
.02 to Rule 602 to provide that, ``Lead Market Makers and Registered
Market Makers shall request appointments to (and relinquishment of
appointments from) one or more classes of option contracts traded on
the Exchange pursuant to Rule 602(a) via an Exchange approved
electronic interface, which request must be submitted prior to 6:00
p.m. Eastern Time of the business day immediately preceding the next
trading day. The Exchange approved electronic interface will also
ensure that, before any appointment request (or relinquishment of an
appointment) is approved, the CQL established by Rule 602 has not been
exceeded. Appointments (and relinquishments of appointments) shall
become effective on the day after the request is submitted, provided
that it has been approved. Approvals and denials of appointments (and
relinquishment of appointments) shall be communicated by the Exchange
via the same Exchange approved electronic interface through which the
request was made.''
    The Exchange believes that requiring LMMs and RMMs to use an
Exchange approved electronic interface to request appointments to one
or more classes of option contracts would enable LMMs and RMMs to
efficiently request appointments (and relinquishment of appointments)
and get notified of approvals or denials related to such requests,
which, in turn, would limit the time and resources expended by such
Market Makers and the Exchange on the appointment process.
    The Exchange also believes this proposal would provide LMMs and
RMMs with efficient access to the securities in which they want to make
markets and disseminate competitive quotations by harmonizing the
process to be identical to the process currently in place on MIAX
Options, which would provide additional liquidity and enhance
competition in those securities. The Exchange would retain the ability
to suspend or terminate any appointment of a Market Maker if necessary
to maintain a fair and orderly market.\18\ The Exchange notes that the
proposed changes to Rule 602 are identical to changes made by MIAX
Options when it modified its rule,\19\ and therefore raises no new or
novel issues. Furthermore, the Exchange notes that it is only proposing
to specify the method by which LMMs and RMMs would request appointments
to (and relinquishment of appointments from) one or more classes of
option contracts traded on the Exchange pursuant to Rule 602(a), and
would not change the substantive provisions of the rules including the
CQL, quoting requirements, or the Exchange's ability to make additional
appointments or change the option classes included in a Market Maker's
requested appointment whenever, in the Board's or designated

committee's judgment, the interests of a fair and orderly market are
best served by such action.
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    \18\ See Rule 602(e).
    \19\ See supra note 5.
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2. Statutory Basis
    The Exchange believes that its proposed rule change is consistent
with Section 6(b) of the Act \20\ in general, and furthers the
objectives of Section 6(b)(5) of the Act \21\ in particular, in that it
is designed to prevent fraudulent and manipulative acts and practices,
to promote just and equitable principles of trade, to foster
cooperation and coordination with persons engaged in facilitating
transactions in securities, to remove impediments to and perfect the
mechanisms of a free and open market and a national market system and,
in general, to protect investors and the public interest.
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    \20\ 15 U.S.C. 78f(b).
    \21\ 15 U.S.C. 78f(b)(5).
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    The Exchange believes that requiring LMMs and RMMs to use an
Exchange approved electronic interface to request appointments to one
or more classes of option contracts would enable LMMs and RMMs to
efficiently request appointments (and relinquishment of appointments)
and get notified of approvals or denials related to such requests,
which, in turn, would limit the time and resources expended by such
Market Makers and the Exchange on the appointment process, through the
use of an automated tool. The Exchange believes the proposed change
would reduce the burden on both LMMs and RMMs, and Exchange staff by
harmonizing the process to be identical to MIAX Options, which would
result in a fair and reasonable use of resources to the benefit of all
market participants. In particular, the proposal to require LMMs and
RMMs to use an Exchange approved electronic interface to request to be
appointed to a class, and to make changes thereto, is consistent with
Act because it would provide LMMs and RMMs with efficient access to the
securities in which they want to make markets by harmonizing the
process to be identical to the process currently in place on MIAX
Options. The Exchange also believes that allowing LMMs and RMMs to
request relinquishment from appointments using the same process used by
LMMs and RMMs to request appointments, would serve to promote just and
equitable principles of trade and benefit investors and the public
interest by establishing a systematic way for LMMs and RMMs to manage
their appointments and provide more clarity with respect to the
process, which also serves to promote consistency and transparency for
such Market Makers.
    In addition, the Exchange believes that clarifying the process by
which LMMs and RMMs request appointments and relinquishment of
appointments on an automated basis and harmonizing such process with
that of MIAX Options is likewise consistent with the Act. First, the
Board or a designated committee will continue to have responsibility
for approving the appointments requested by LMMs and RMMs in one or
more classes of options contracts traded on the Exchange. The Board or
a designated committee would continue to consider the relevant factors
and conduct an evaluation of Market Makers prior to their
appointment.\22\ In addition, as noted above, the Exchange would
continue to have authority to suspend or terminate any Market Maker
appointment in the interest of a fair and orderly market, including, if
necessary to prevent fraudulent and manipulative acts and practices and
protect investors, or if a Market Maker does not satisfy its
obligations with respect to an appointment.\23\ Furthermore, the
Exchange approved electronic interface utilized by LMMs and RMMs to
request an appointment will ensure that, before any additions to a
Market Maker's appointment are approved, the CQL established by Rule
602 has not been exceeded. Accordingly, the Exchange believes this
proposal is consistent with Section 6(b) of the Exchange Act.\24\
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    \22\ See supra notes 11-15.
    \23\ See Rule 602(e). See also Rule 600(c) (regarding the
Exchange's ability to suspend or terminate a Market Maker's
registration based on ``a determination that such Member has failed
to properly perform as a Market Maker.'').
    \24\ 15 U.S.C. 78f(b).
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    The proposed rule change would not result in unfair discrimination,
as it applies to all LMMs and RMMs equally. As noted above, the
Exchange intentionally excluded PLMMs from this proposal. The Exchange
believes it isn't unfairly discriminatory to exclude PLMMs from this
new appointment method because the Board or designated committee
appoints only one PLMM to each options class traded on the Exchange, as
opposed to the multiple number of LMMs and RMMs, and because of the
heightened obligations associated with performing the responsibilities
of a PLMM.\25\ Because of these heightened responsibilities of PLMMs,
the Exchange believes that it is not unfairly discriminatory to treat
PLMMs differently from LMMs and RMMs with respect to the method by
which appointments (and relinquishments of appointments) are requested.
---------------------------------------------------------------------------

    \25\ See supra note 10.
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    Further, the proposed rule change would provide LMMs and RMMs with
efficient access to the securities in which they want to make markets
and disseminate competitive quotations by harmonizing the process to be
identical to the process currently in place on MIAX Options, which
would provide additional liquidity and enhance competition in those
securities, while limiting the time and resources expended by such
Market Makers and the Exchange on the appointment process.
Nevertheless, Market Makers would still be required to comply with
certain obligations to maintain their status as a Market Maker,
including that they provide continuous, two-sided quotations in their
appointed securities.\26\
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    \26\ See Rule 604.
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    Finally, as noted above, specifying the method of the appointment
process would also align the rules of the Exchange with the rules of
other options exchanges and to the rules of MIAX Options, where Market
Makers presently have the ability to select and make changes to their
appointments and registrations via an exchange-approved electronic
interface.\27\ The Exchange believes this consistency across exchanges
would remove impediments to and perfect the mechanism of a free and
open market by ensuring that members, regulators and the public can
more easily navigate the Exchange's rulebook and better understand the
appointment process.
---------------------------------------------------------------------------

    \27\ See supra note 7.
---------------------------------------------------------------------------

    Additionally, the Exchange believes that although MIAX Emerald
rules may, in certain instances, intentionally differ from MIAX Options
rules, the proposed changes will promote uniformity with MIAX Options
with respect to rules that are intended to be identical. The Exchange
believes that it will reduce the potential for confusion by its members
that are also members of MIAX Options with respect to rules that are
intended to be identical.

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

    MIAX Emerald does not believe that the proposed rule change will
impose any burden on competition that is not necessary or appropriate
in furtherance of the purposes of the Act because it provides for the
same process to a group of similarly situated market participants, LMMs
and RMMs. The proposed rule change would provide LMMs and RMMs with
efficient access to the securities in which they want to make markets
and disseminate competitive quotations by harmonizing

the process to be identical to the process currently in place on MIAX
Options, which would provide additional liquidity and enhance
competition in those securities, while limiting the time and resources
expended by such Market Makers and the Exchange on the appointment
process. Additionally, the proposed rule change will help to provide
more clarity with respect to the appointment process, which also serves
to promote consistency and transparency for such Market Makers.
    The Exchange does not believe the proposed rule change would help
these Market Makers to the detriment of market participants on other
exchanges, particularly because the proposed appointment process for
LMMs and RMMs is meant to simply create an efficient and clear process
by which such Market Makers can request an appointment, and it is
similar to the appointment and registration processes for market makers
already in place on other exchanges.\28\ LMMs and RMMs would still be
subject to the same obligations with respect to its appointment;
however, the proposed rule change would make the appointment process
efficient for such Market Makers. The Exchange believes that the
proposed rule change would relieve any burden on, or otherwise promote,
competition, as it would enable LMMs and RMMs to efficiently request
appointments (and relinquishment of appointments) and get notified of
approvals or denials related to such requests, which, in turn, would
limit the time and resources expended by such Market Makers and the
Exchange on the appointment process.
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    \28\ Id.
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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

    Because the foregoing proposed rule change does not: (i)
Significantly affect the protection of investors or the public
interest; (ii) impose any significant burden on competition; and (iii)
become operative for 30 days after the date of the filing, or such
shorter time as the Commission may designate, it has become effective
pursuant to 19(b)(3)(A) of the Act \29\ and Rule 19b-4(f)(6) \30\
thereunder.
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    \29\ 15 U.S.C. 78s(b)(3)(A).
    \30\ 17 CFR 240.19b-4(f)(6). In addition, Rule 19b-4(f)(6)
requires a self-regulatory organization to give the Commission
written notice of its intent to file the proposed rule change at
least five business days prior to the date of filing of the proposed
rule change, or such shorter time as designated by the Commission.
The Exchange has satisfied this requirement.
---------------------------------------------------------------------------

    A proposed rule change filed pursuant to Rule 19b-4(f)(6) under the
Act \31\ normally does not become operative for 30 days after the date
of its filing. However, Rule 19b-4(f)(6)(iii) \32\ permits the
Commission to designate a shorter time if such action is consistent
with the protection of investors and the public interest. In its filing
with the Commission, the Exchange has asked the Commission to waive the
30-day operative delay so that the proposal may become operative
immediately upon filing. The Commission believes that waiving the 30-
day operative delay is consistent with the protection of investors and
the public interest. The Commission notes that waiver of the operative
delay will allow the proposed rules to become operative before the
Exchange intends to commence operations as a national exchange. The
Commission notes that the proposed rule change is based on a
substantively identical rule of MIAX Options and thus raises no new
novel or substantive issues. Accordingly, the Commission hereby waives
the operative delay and designates the proposal operative upon
filing.\33\
---------------------------------------------------------------------------

    \31\ 17 CFR 240.19b-4(f)(6).
    \32\ 17 CFR 240.19b-4(f)(6)(iii).
    \33\ For purposes only of waiving the 30-day operative delay,
the Commission has also considered the proposed rule's impact on
efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
---------------------------------------------------------------------------

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

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR- EMERALD-2019-05 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-EMERALD-2019-05. This
file number should be included on the subject line if email is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's internet website (http://www.sec.gov/rules/sro.shtml).
Copies of the submission, all subsequent amendments, all written
statements with respect to the proposed rule change that are filed with
the Commission, and all written communications relating to the proposed
rule change between the Commission and any person, other than those
that may be withheld from the public in accordance with the provisions
of 5 U.S.C. 552, will be available for website viewing and printing in
the Commission's Public Reference Room, 100 F Street NE, Washington, DC
20549, on official business days between the hours of 10:00 a.m. and
3:00 p.m. Copies of the filing also will be available for inspection
and copying at the principal office of the Exchange. All comments
received will be posted without change. Persons submitting comments are
cautioned that we do not redact or edit personal identifying
information from comment submissions. You should submit only
information that you wish to make available publicly. All submissions
should refer to File Number SR-EMERALD-2019-05 and should be submitted
on or before March 26, 2019.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\34\
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    \34\ 17 CFR 200.30-3(a)(12).
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Eduardo A. Aleman,
Deputy Secretary.
[FR Doc. 2019-03891 Filed 3-4-19; 8:45 am]
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[Federal Register: April 30, 2008 (Volume 73, Number 84)]
[Rules and Regulations]
[Page 23322-23323]
[DOCID:fr30ap08-3]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2008-0066; Airspace Docket No. 08-ANE-97]

Establishment of Class E Airspace; Dover-Foxcroft, ME

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule, correction, confirmation of effective date.

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SUMMARY: The Federal Aviation Administration published in the Federal
Register of February 21, 2008 (73 FR 9448), a document establishing
Class E airspace at Dover-Foxcroft, ME. This action confirms the
effective date of a direct final rule that establishes Class E Airspace
at Dover-Foxcroft, ME to support a new Area Navigation (RNAV) Global
Positioning System (GPS) Special Instrument Approach Procedure (IAP)
that has been developed for medical flight operations into the Mayo
Regional Hospital Heliport and technically corrects the omission of the
word ``heliport'' from the name of Mayo Regional Hospital Heliport.

DATES: Effective 0901 UTC, June 5, 2008. 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 7400.9 and publication of conforming amendments.

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

SUPPLEMENTARY INFORMATION:

Confirmation of Effective Date

    The FAA published this direct final rule with a request for
comments in the Federal Register on February 21, 2008 (73 FR 9448) to
establish Class E airspace at Dover-Foxcroft, ME. The FAA uses the
direct final rulemaking procedure for a non-controversial rule where
the FAA believes that there will be no adverse public comment. This
direct final rule advised the public that no adverse comments were
anticipated, and that unless a written adverse comment, or a written
notice of intent to submit such an adverse comment, were received
within the comment period, the regulation would become effective on
June 5, 2008. No adverse comments were received, and thus this notice
confirms that effective date.

Correction to Final Rule

    After publication in the Federal Register, it was discovered that
the word heliport was omitted from the name of the hospital and was
incorrectly published as ``Mayo Regional Hospital''. The name should
have read ``Mayo Regional Hospital Heliport''. This action corrects
that error.
    Accordingly, pursuant to the authority delegated to me, the name
for Mayo Regional Hospital, Dover-

Foxcroft, ME, as published in the Federal Register on February 21, 2008
(73 FR 9448), Federal Docket No. FAA-2008-0066 is corrected as follows:

Sec.  71.1  [Corrected]

* * * * *
Mayo Regional Hospital [Corrected]

ANE ME E5 Dover-Foxcroft, ME [NEW]

Mayo Regional Hospital Heliport
    (Lat. 45[deg]11'19'' N., long. 69[deg]14'12'' W.)
Point in Space Coordinates
    (Lat. 45[deg]11'31'' N., long. 69[deg]15'24'' W.)

    That airspace extending upward from 700 feet above the surface
of the Earth within a 6-mile radius of the Point in Space
Coordinates (lat. 45[deg]11'31'' N., long. 69[deg]15'24'' W.)
serving the Mayo Regional Hospital Heliport.
* * * * *

    Issued in College Park, Georgia, on April 8, 2008.
Kathy Swann,
Acting Manager, System Support Group, Eastern Service Center, Air
Traffic Organization.
[FR Doc. E8-9043 Filed 4-29-08; 8:45 am]

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