[Federal Register Volume 85, Number 191 (Thursday, October 1, 2020)]
[Notices]
[Pages 61999-62001]
[FR Doc No: 2020-21661]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-90005; File No. SR-NYSE-2020-78]

Self-Regulatory Organizations; New York Stock Exchange LLC;
Notice of Filing and Immediate Effectiveness of Proposed Rule Change To
Extend the Temporary Period for Specified Commentaries to Rules 7.35,
7.35A, 7.35B, and 7.35C and Temporary Rule Relief in Rule 36.30

September 25, 2020.
    Pursuant to Section 19(b)(1) \1\ of the Securities Exchange Act of
1934 (the ``Act'') \2\ and Rule 19b-4 thereunder,\3\ notice is hereby
given that on September 23, 2020, New York Stock Exchange LLC (``NYSE''
or the ``Exchange'') filed with the Securities and Exchange Commission
(the ``Commission'') the proposed rule change as described in Items I
and II below, which Items have been prepared by the self-regulatory
organization. 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\ 15 U.S.C. 78a.
    \3\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to extend the temporary period for specified
Commentaries to Rules 7.35, 7.35A, 7.35B, and 7.35C and temporary rule
relief in Rule 36.30, to end on the earlier of a full reopening of the
Trading Floor facilities to DMMs or after the Exchange closes on
December 31, 2020. The proposed rule change is available on the
Exchange's website at www.nyse.com, at the principal office of the
Exchange, and at the Commission's Public Reference Room.

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

    In its filing with the Commission, the self-regulatory organization
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 those 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 parts of such statements.

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

1. Purpose
    The Exchange proposes to extend the temporary period for specified
Commentaries to Rules 7.35, 7.35A, 7.35B, and 7.35C and temporary rule
relief to Rule 36.30, to end on the earlier of a full reopening of the
Trading Floor facilities to DMMs or after the Exchange closes on
December 31, 2020. The current temporary period that these Rules are in
effect ends on the earlier of a full reopening of the Trading Floor
facilities to DMMs or after the Exchange closes on September 30, 2020.
Background
    To slow the spread of COVID-19 through social-distancing measures,
on March 18, 2020, the CEO of the Exchange made a determination under
Rule 7.1(c)(3) that, beginning March 23, 2020, the Trading Floor
facilities located at 11 Wall Street in New York City would close and
the Exchange would move, on a temporary basis, to fully

electronic trading.\4\ On May 14, 2020, the CEO of the Exchange made a
determination under Rule 7.1(c)(3) to reopen the Trading Floor on a
limited basis on May 26, 2020 to a subset of Floor brokers, subject to
safety measures designed to prevent the spread of COVID-19.\5\ On June
15, 2020, the CEO of the Exchange made a determination under Rule
7.1(c)(3) to begin the second phase of the Trading Floor reopening by
allowing DMMs to return on June 17, 2020, subject to safety measures
designed to prevent the spread of COVID-19.\6\ Consistent with these
safety measures, both DMMs and Floor broker firms continue to operate
with reduced staff on the Trading Floor.
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    \4\ Pursuant to Rule 7.1(e), the CEO notified the Board of
Directors of the Exchange of this determination. The Exchange's
current rules establish how the Exchange will function fully-
electronically. The CEO also closed the NYSE American Options
Trading Floor, which is located at the same 11 Wall Street
facilities, and the NYSE Arca Options Trading Floor, which is
located in San Francisco, CA. See Press Release, dated March 18,
2020, available here: https://ir.theice.com/press/press-releases/all-categories/2020/03-18-2020-204202110.
    \5\ See Securities Exchange Act Release No. 88933 (May 22,
2020), 85 FR 32059 (May 28, 2020) (SR-NYSE-2020-47) (Notice of
filing and immediate effectiveness of proposed rule change).
    \6\ See Securities Exchange Act Release No. 89086 (June 17,
2020) (SR-NYSE-2020-52) (Notice of filing and immediate
effectiveness of proposed rule change).
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Proposed Rule Change
    The Exchange has modified its rules to add Commentaries to Rules
7.35, 7.35A, 7.35B, and 7.35C and rule relief in Rule 36.30 \7\ that
are in effect until the earlier of a full reopening of the Trading
Floor facilities to DMMs or after the Exchange closes on September 30,
2020.\8\
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    \7\ See Securities Exchange Act Release Nos. 88413 (March 18,
2020), 85 FR 16713 (March 24, 2020) (SR-NYSE-2020-19) (amending Rule
7.35C to add Commentary .01); 88444 (March 20, 2020), 85 FR 17141
(March 26, 2020) (SR-NYSE-2020-22) (amending Rules 7.35A to add
Commentary .01, 7.35B to add Commentary .01, and 7.35C to add
Commentary .02); 88488 (March 26, 2020), 85 FR 18286 (April 1, 2020)
(SR-NYSE-2020-23) (amending Rule 7.35A to add Commentary .02); 88546
(April 2, 2020), 85 FR 19782 (April 8, 2020) (SR-NYSE-2020-28)
(amending Rule 7.35A to add Commentary .03); 88562 (April 3, 2020),
85 FR 20002 (April 9, 2020) (SR-NYSE-2020-29) (amending Rule 7.35C
to add Commentary .03); 88705 (April 21, 2020), 85 FR 23413 (April
27, 2020) (SR-NYSE-2020-35) (amending Rule 7.35A to add Commentary
.04); 88725 (April 22, 2020), 85 FR 23583 (April 28, 2020) (SR-NYSE-
2020-37) (amending Rule 7.35 to add Commentary .01); 88950 (May 26,
2020), 85 FR 33252 (June 1, 2020) (SR-NYSE-2020-48) (amending Rule
7.35A to add Commentary .05); 89059 (June 12, 2020), 85 FR 36911
(June 18, 2020) (SR-NYSE-2020-50) (amending Rule 7.35C to add
Commentary .04); 89086 (June 17, 2020), 85 FR 37712 (SR-NYSE-2020-
52) (amending Rules 7.35A to add Commentary .06, 7.35B to add
Commentary .03, 76 to add Supplementary Material 20, and
Supplementary Material .30 to Rule 36); and 89925 (September 18,
2020) (SR-NYSE-2020-75) (amending Rule 7.35 to add Commentary .02).
    \8\ See Securities Exchange Act Release No. 89425 (July 30,
2020), 85 FR 47446 (August 5, 2020) (SR-NYSE-2020-63) (Notice of
filing and immediate effectiveness of proposed rule change to extend
the temporary period for Commentaries to Rules 7.35, 7.35A, 7.35B,
and 7.35C and temporary rule relief in Rule 36.30 to end on the
earlier of a full reopening of the Trading Floor facilities to DMMs
or after the Exchange closes on September 30, 2020. See also
Securities Exchange Act Release Nos. 89199 (June 30, 2020), 85 FR
40718 (July 7, 2020) (SR-NYSE-2020-56) (Notice of filing and
immediate effectiveness of proposed rule change to extend the
temporary period for Commentaries to Rules 7.35, 7.35A, 7.35B, and
7.35C; Supplementary Material .20 to Rule 76; and temporary rule
relief in Rule 36.30 to end on the earlier of a full reopening of
the Trading Floor facilities to DMMs or after the Exchange closes on
July 31, 2020); and 89368 (July 21, 2020), 85 FR 45272 (July 27,
2020) (SR-NYSE-2020-61) (Notice of filing and immediate
effectiveness of proposed rule change to lift the temporary
suspension to Rule 76 and delete Supplementary Material .20 to Rule
76).
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    The first and second phases of the reopening of the Trading Floor
are subject to safety measures designed to prevent the spread of COVID-
19. To meet these safety measures, Floor brokers and DMM units that
have chosen to return to the Trading Floor are operating with reduced
staff. The Exchange is therefore proposing to extend the following
temporary rules until such time that there is a full reopening of the
Trading Floor facilities to DMMs:
     Commentaries .01 and .02 to Rule 7.35; \9\
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    \9\ Because DMMs are not obligated to return to a Floor, an IPO
Auction may still be conducted by a DMM remotely as provided for in
Commentary .04 to Rule 7.35A. If a DMM chooses to conduct an IPO
Auction remotely, Floor brokers on the Trading Floor will not have
access to IPO Auction imbalance information. The Exchange proposes a
non-substantive change to Commentary .02 to Rule 7.35 to change the
start date of that Commentary from September 20, 2020 to September
4, 2020, which is consistent with the date represented in the
proposed rule change adopting that Commentary. See Securities
Exchange Act Release No. 89925 (September 18, 2020) (SR-NYSE-2020-
75) (amending Rule 7.35 to add Commentary .02)
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     Commentaries .01, .02, .03, .04, .05, and .06 to Rule
7.35A;
     Commentaries .01 and .03 to Rule 7.35B;
     Commentaries .01, .02, .03, and .04 to Rule 7.35C; and
     Amendments to Rule 36.30.
    The Exchange is not proposing any substantive changes to these
Rules.
2. Statutory Basis
    The proposed rule change is consistent with Section 6(b) of the
Act,\10\ in general, and furthers the objectives of Section 6(b)(5) of
the Act,\11\ 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, and to
remove impediments to and perfect the mechanism of a free and open
market and a national market system.
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    \10\ 15 U.S.C. 78f(b).
    \11\ 15 U.S.C. 78f(b)(5).
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    To reduce the spread of COVID-19, the CEO of the Exchange made a
determination under Rule 7.1(c)(3) that beginning March 23, 2020, the
Trading Floor facilities located at 11 Wall Street in New York City
would close and the Exchange would move, on a temporary basis, to fully
electronic trading. On May 14, 2020, the CEO made a determination under
Rule 7.1(c)(3) that, beginning May 26, 2020, the Trading Floor would be
partially reopened to allow a subset of Floor brokers to return to the
Trading Floor. On June 15, 2020, the CEO made a determination under
Rule 7.1(c)(3) that, beginning June 17, 2020, DMM units may choose to
return a subset of staff to the Trading Floor.
    The Exchange believes that the proposed rule change would remove
impediments to and perfect the mechanism of a free and open market and
a national market system because the Trading Floor has not yet reopened
in full to DMMs or Floor brokers. Accordingly, the Exchange believes
that the temporary rule changes in effect pursuant to the Commentaries
to Rules 7.35, 7.35A, 7.35B, and 7.35C and amendments to Rule 36.30,
which are intended to be in effect during the temporary period while
the Trading Floor has not yet opened in full to DMMs, should be
extended until such time that there is a full reopening of the Trading
Floor facilities to DMMs. The Exchange is not proposing any substantive
changes to these Rules.
    The Exchange believes that, by clearly stating that this relief
will be in effect through the earlier of a full reopening of the
Trading Floor facilities to DMMs or the close of the Exchange on
December 31, 2020, market participants will have advance notice of the
temporary period during which the Commentaries to Rules 7.35, 7.35A,
7.35B, and 7.35C and amendments to Rule 36.30 will be in effect.

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

    The Exchange does not believe that the proposed rule change would
impose any burden on competition that is not necessary or appropriate
in furtherance of the purposes of the Act. The proposed rule change is
not designed to address any competitive issues but rather would extend
the period during which Commentaries .01 and .02 to Rule 7.35;
Commentaries .01, .02, .03, .04, 05,

and .06 to Rule 7.35A; Commentaries .01 and .03 to Rule 7.35B;
Commentaries .01, .02, .03, and .04 to Rule 7.35C; and amendments to
Rule 36.30 will be in effect. These Commentaries are intended to be in
effect during the temporary period while the Trading Floor has not yet
been opened in full to DMMs and Floor brokers and currently expire on
September 30, 2020. Because the Trading Floor has not been opened in
full to DMMs, the Exchange proposes to extend the temporary period for
these temporary rules to end on the earlier of a full reopening of the
Trading Floor facilities to DMMs or after the Exchange closes on
December 31, 2020.

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

    No written comments were solicited or received with respect to the
proposed rule change.

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

    The Exchange has filed the proposed rule change pursuant to Section
19(b)(3)(A)(iii) of the Act \12\ and Rule 19b-4(f)(6) thereunder.\13\
Because the proposed rule change does not (i) significantly affect the
protection of investors or the public interest; (ii) impose any
significant burden on competition; or (iii) become operative prior to
30 days from the date on which it was filed, or such shorter time as
the Commission may designate, if consistent with the protection of
investors and the public interest, the proposed rule change has become
effective pursuant to Section 19(b)(3)(A)(iii) of the Act \14\ and Rule
19b-4(f)(6)(iii) thereunder.\15\
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    \12\ 15 U.S.C. 78s(b)(3)(A)(iii).
    \13\ 17 CFR 240.19b-4(f)(6).
    \14\ 15 U.S.C. 78s(b)(3)(A)(iii).
    \15\ 17 CFR 240.19b-4(f)(6). In addition, Rule 19b-4(f)(6)(iii)
requires a self-regulatory organization to give the Commission
written notice of its intent to file the proposed rule change, along
with a brief description and text of 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 fulfilled this requirement.
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    A proposed rule change filed under Rule 19b-4(f)(6) \16\ normally
does not become operative prior to 30 days after the date of the
filing. However, pursuant to Rule 19b-4(f)(6)(iii),\17\ the Commission
may designate a shorter time if such action is consistent with the
protection of investors and the public interest. The Exchange has asked
the Commission to waive the 30-day operative delay so that the proposal
may take effect immediately. The Commission believes that waiver of the
operative delay is consistent with the protection of investors and the
public interest because it will allow the rules discussed above to
remain in effect during the temporary period during which the Trading
Floor has not yet been reopened in full to DMMs because of health
precautions related to the COVID-19 pandemic. Accordingly, the
Commission hereby waives the 30-day operative delay and designates the
proposal operative upon filing.\18\
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    \16\ 17 CFR 240.19b-4(f)(6).
    \17\ 17 CFR 240.19b-4(f)(6)(iii).
    \18\ For purposes only of accelerating the operative date of
this proposal, the Commission has considered the proposed rule's
impact on efficiency, competition, and capital formation. 15 U.S.C.
78c(f).
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    At any time within 60 days of the filing of such 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 under
Section 19(b)(2)(B) \19\ of the Act to determine whether the proposed
rule change should be approved or disapproved.
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    \19\ 15 U.S.C. 78s(b)(2)(B).
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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-NYSE-2020-78 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-NYSE-2020-78. 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-NYSE-2020-78 and should be submitted on
or before October 22, 2020.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\20\
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    \20\ 17 CFR 200.30-3(a)(12).
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J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2020-21661 Filed 9-30-20; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 87, Number 24 (Friday, February 4, 2022)]
[Notices]
[Pages 6577-6578]
[FR Doc No: 2022-02371]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-D-1636]

Assessment of Pressor Effects of Drugs; Revised 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 revised draft guidance for industry entitled
``Assessment of Pressor Effects of Drugs.'' This draft guidance is
intended to advise sponsors on the premarketing assessment of a drug's
effect on blood pressure. Elevated blood pressure is known to increase
the risk of stroke, heart attack, and death. The effect of a drug on
blood pressure is, therefore, an important consideration in risk
assessment and product labeling. This draft guidance revises the draft
guidance for industry ``Assessment of Pressor Effects of Drugs'' issued
on May 31, 2018.

DATES: Submit either electronic or written comments on the draft
guidance by April 5, 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-2018-D-1636 for ``Assessment of Pressor Effects of Drugs.''
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. 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: Devi Kozeli, Center for Drug
Evaluation and Research (HFD-110), Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 22, Rm. 4183, Silver Spring, MD 20903, 301-
796-2240.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a revised draft guidance for
industry entitled ``Assessment of Pressor Effects of Drugs.'' This
draft guidance is intended to advise sponsors on the premarketing
assessment of a drug's effect on blood pressure. Elevated blood
pressure is known to increase the risk of stroke, heart attack, and
death. The effect of a drug on blood pressure is, therefore, an
important consideration in risk assessment and product labeling.
    This draft guidance revises the draft guidance entitled
``Assessment of Pressor Effects of Drugs'' issued on May 31, 2018 (83
FR 25013). Based on comments received to the docket, the draft guidance
was updated to include recommendations on the design of an ambulatory
blood pressure monitoring study; recommendations on the types of drugs
that need an ambulatory blood pressure monitoring study; modification
of Figure 1 in the draft guidance to show the relationship between the
increase in 10-year atherosclerotic cardiovascular disease event risk
with chronic increases in systolic blood pressure; inclusion in the
guidance of Table 1, which summarizes landmark clinical trials showing
the reduction of major adverse cardiac events with decreases in blood
pressure with antihypertensives; and considerations for product
labeling. In addition, editorial changes were made to improve clarity.
    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 ``Assessment
of Pressor Effects of Drugs.'' 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

    While this draft 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 21 CFR part 312 addressing investigational new drug
applications have been approved under OMB control number 0910-0014 and
the collections of information in 21 CFR part 314 addressing new drug
applications have been approved under OMB control number 0910-0001.

III. Electronic Access

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

    Dated: January 31, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-02371 Filed 2-3-22; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 87, Number 240 (Thursday, December 15, 2022)]
[Notices]
[Pages 76645-76648]
[FR Doc No: 2022-27162]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-96472; File No. SR-PEARL-2022-53]

Self-Regulatory Organizations; MIAX PEARL, LLC; Notice of Filing
and Immediate Effectiveness of a Proposed Rule Change To Amend the MIAX
Pearl Equities Fee Schedule

December 9, 2022.
    Pursuant to section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'') \1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on November 30, 2022, MIAX PEARL, LLC (``MIAX Pearl'' or ``Exchange'')
filed with the Securities and Exchange Commission (``Commission'') a
proposed rule change as described in Items I, II, and III below, which
Items have been prepared by the Exchange. The Commission is publishing
this notice to solicit comments on the proposed rule change from
interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange is filing a proposal to amend the fee schedule (the
``Fee Schedule'') applicable to MIAX Pearl Equities, an equities
trading facility of the Exchange.
    The text of the proposed rule change is available on the Exchange's
website at http://www.miaxoptions.com/rule-filings/pearl, at MIAX
Pearl'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 purpose of the proposed rule change is to amend the Exchange's
Fee Schedule to (i) adopt a reduced fee for executions of Midpoint Peg
Orders \3\ that remove liquidity and execute at the midpoint of the
Protected NBBO (``PBBO''); \4\ (ii) adopt a new Liquidity Code and
associated fee to the Liquidity Indicator Codes and Associated Fees
table for a Midpoint Peg Order; and (iii) update the Standard Rates
table to include the new Liquidity Indicator Code in the Removing
Liquidity column.
---------------------------------------------------------------------------

    \3\ A Midpoint Peg Order is a non-displayed Limit Order that is
assigned a working price pegged to the midpoint of the PBBO. A
Midpoint Peg Order receives a new timestamp each time its working
price changes in response to changes to the midpoint of the PBBO.
See Exchange Rule 2614(a)(3).
    \4\ With respect to the trading of equity securities, the term
``Protected NBB'' or ``PBB'' shall mean the national best bid that
is a Protected Quotation, the term ``Protected NBO'' or ``PBO''
shall mean the national best offer that is a Protected Quotation,
and the term ``Protected NBBO'' or ``PBBO'' shall mean the national
best bid and offer that is a Protected Quotation. See Exchange Rule
1901.
---------------------------------------------------------------------------

    The Exchange first notes that it operates in a highly competitive
market in which market participants can readily direct order flow to
competing venues if they deem fee levels at a particular venue to be
excessive or incentives to be insufficient. More specifically, the
Exchange is only one of 16 registered equities exchanges, as well as a
number of alternative trading systems and other off-exchange venues, to
which market participants may direct their order flow. Based on
publicly available information, no single registered equities exchange
currently has more than approximately 17% of the total market share of
executed volume of equities trading, and the Exchange currently
represents approximately 1.06% of the overall market share.\5\
---------------------------------------------------------------------------

    \5\ See MIAX's ``The market at a glance/Equities/MTD AVERAGE'',
available at https://www.miaxoptions.com/ (Data as of 11/1/2022-11/
18/2022).
---------------------------------------------------------------------------

Midpoint Peg Orders
    The Exchange currently charges a standard fee of $0.0029 per share
for executions of orders in securities priced at or above $1.00 per
share that remove liquidity from the Exchange in all Tapes (such
orders, ``Removed Liquidity''). The Exchange now proposes to adopt a
reduced fee of $0.00265 per share for executions of Midpoint Peg Orders
in securities priced at or above $1.00 that execute at the midpoint of
the PBBO and remove liquidity from the Exchange in all Tapes. As
proposed, executions of Midpoint Peg Orders in securities priced below
$1.00 per share that execute at the midpoint of the PBBO and remove
liquidity from the Exchange will be charged a fee of 0.20% of the total
dollar of the transaction, which is the same fee that is currently
charged for all such executions.
    The purpose of reducing the fee for executions of Midpoint Peg
Orders is to incentivize Equity Members \6\ (or ``Members'') to submit
additional liquidity-removing orders designed to execute at the
midpoint to the Exchange, as the cost of such executions would be lower
than it is today. In turn, the Exchange believes the submission of
additional Midpoint Peg Orders would encourage firms that post
liquidity at the midpoint to submit additional liquidity-providing
orders designed to execute at the midpoint to the Exchange, as such
orders would have a greater chance of being executed as a

result of additional contra-side liquidity-removing Midpoint Peg Orders
to interact with. Thus, the Exchange's proposal to reduce the fee for
executions of Midpoint Peg Orders is designed to deepen liquidity and
increase execution opportunities at the midpoint on the Exchange,
thereby improving the Exchange's market quality to the benefit of all
Members and enhancing its attractiveness as a trading venue.
---------------------------------------------------------------------------

    \6\ The term ``Equity Member'' is a Member authorized by the
Exchange to transact business on MIAX Pearl Equities. See Exchange
Rule 1901.
---------------------------------------------------------------------------

    The Exchange proposes to update the Liquidity Indicator Code and
Associated Fees Table as follows:
     Add new liquidity indicator code Rp, Removes Liquidity and
Executes at the Midpoint, Non-Displayed Midpoint Peg Order (All Tapes).
The Liquidity Indicator Code and Associated Fees table would specify
that orders that yield liquidity indicator code Rp would be assessed a
fee of $0.00265 per share in securities priced at or above $1.00 and
0.20% of the transaction's dollar value in securities priced below
$1.00.
    The Exchange also proposes to add the above liquidity indicator
code to the Standard Rates table. Specifically, liquidity indicator
code Rp would be added to the ``Remove Liquidity'' column.
Implementation
    The Exchange proposes to implement the changes to the Fee Schedule
pursuant to this proposal on December 1, 2022.
2. Statutory Basis
    The Exchange believes that its proposal to amend its Fee Schedule
is consistent with Section 6(b) of the Act \7\ in general, and furthers
the objectives of section 6(b)(4) of the Act \8\ in particular, in that
it is an equitable allocation of reasonable fees and other charges
among its Equity Members and issuers and other persons using its
facilities. The Exchange also believes that the proposed rule change is
consistent with the objectives of section 6(b)(5) \9\ requirements that
the rules of an exchange be designed to prevent fraudulent and
manipulative acts and practices, and to promote just and equitable
principles of trade, to foster cooperation and coordination with
persons engaged in regulating, clearing, settling, processing
information with respect to, and facilitating transactions in
securities, to remove impediments to and perfect the mechanism of a
free and open market and a national market system, and, in general, to
protect investors and the public interest, and, particularly, is not
designed to permit unfair discrimination between customers, issuers,
brokers, or dealers.
---------------------------------------------------------------------------

    \7\ 15 U.S.C. 78f(b).
    \8\ 15 U.S.C. 78f(b)(4).
    \9\ 15 U.S.C 78f(b)(5).
---------------------------------------------------------------------------

    The Exchange operates in a highly fragmented and competitive market
in which market participants can readily direct their order flow to
competing venues if they deem fee levels at a particular venue to be
excessive or incentives to be insufficient. More specifically, the
Exchange is only one of sixteen registered equities exchanges, and
there are a number of alternative trading systems and other off-
exchange venues, to which market participants may direct their order
flow. Based on publicly available information, no single registered
equities exchange currently has more than approximately 17% of the
total market share of executed volume of equities trading.\10\ Thus, in
such a low-concentrated and highly competitive market, no single
equities exchange possesses significant pricing power in the execution
of order flow, and the Exchange currently represents less than 1.06% of
the overall market share. The Commission and the courts have repeatedly
expressed their preference for competition over regulatory intervention
in determining prices, products, and services in the securities
markets. In Regulation NMS, the Commission highlighted the importance
of market forces in determining prices and SRO revenues and also
recognized that current regulation of the market system ``has been
remarkably successful in promoting market competition in its broader
forms that are most important to investors and listed companies.'' \11\
---------------------------------------------------------------------------

    \10\ See supra note 5.
    \11\ Securities Exchange Act Release No. 51808 (June 9, 2005),
70 FR 37499 (June 29, 2005).
---------------------------------------------------------------------------

    The Exchange believes that the ever-shifting market share among the
exchanges from month to month demonstrates that market participants can
shift order flow or discontinue to reduce use of certain categories of
products, in response to new or different pricing structures being
introduced into the market. Accordingly, competitive forces constrain
the Exchange's transaction fees and rebates, and market participants
can readily trade on competing venues if they deem pricing levels at
those other venues to be more favorable. The Exchange believes the
proposal reflects a reasonable and competitive pricing structure
designed to incentivize market participants to direct their order flow
to the Exchange, which the Exchange believes would enhance liquidity
and market quality to the benefit of all Members and market
participants.
    The Exchange believes that its proposal to charge a reduced fee for
Midpoint Peg Orders that remove liquidity and execute at the midpoint
is reasonable, equitable, and not unfairly discriminatory.
Specifically, the Exchange believes such proposal is reasonable, as it
is reasonably designed to incentivize Members to submit additional
Midpoint Peg Orders to the Exchange, which, in turn, the Exchange
believes would encourage firms that post midpoint liquidity to submit
additional liquidity-adding orders designed to execute at the midpoint
to the Exchange in order to interact with such Midpoint Peg Orders, as
described above. Thus, the Exchange believes the proposal reflects a
reasonable attempt to deepen liquidity and increase execution
opportunities at the midpoint on the Exchange, thereby improving the
Exchange's market quality to the benefit of all Members and enhancing
its attractiveness as a trading venue, particularly as the Exchange
believes the proposed reduction in the fee for executions of Midpoint
Peg Orders (i.e., $0.00025 per share lower than the standard fee for
Removed Liquidity) is not excessive and is reasonably related to the
market quality benefits it is intended to achieve. The Exchange also
believes that the proposed fee for executions of Midpoint Peg Orders is
equitable and not unfairly discriminatory, as such fee would be charged
uniformly to all executions of such orders for all Members.
New Liquidity Indicator Code
    The Exchange believes its proposal to add new liquidity indicator
code ``Rp'' to the Liquidity Indicator Codes and Associated Fees table
and to add liquidity indicator code ``Rp'' to the ``Removing
Liquidity'' column of the Standard Rates table, is reasonable and
equitable because it will apply equally to all Members of the Exchange
that submit Midpoint Peg Orders that remove liquidity at the midpoint.
This liquidity indicator code would be returned on the real-time trade
reports sent to the Member that submitted the order. The use of
liquidity indicator codes is not unique to the Exchange as liquidity
indicator codes are currently utilized and described in the fee
schedules of other equity exchanges.\12\ Further, the Exchange's
proposed fee of

$0.00265 is competitive with other exchanges that provide a similar
pricing incentive.\13\
---------------------------------------------------------------------------

    \12\ See the fee schedule of MEMX LLC (``MEMX'') available on
their public website at https://info.memxtrading.com/fee-schedule/;
and the fee schedule of the Investors Exchange LLC (``IEX'')
available on their public website at https://exchange.iex.io/resources/trading/fee-schedule/.
    \13\ See fee code ``Rm'' of the MEMX fee schedule that assesses
a $0.0027 fee for removed volume from the MEMX Book, Midpoint Peg,
available on their public website at https://info.memxtrading.com/fee-schedule/.
---------------------------------------------------------------------------

    For the reasons discussed above, the Exchange submits that the
proposal satisfies the requirements of sections 6(b)(4) and 6(b)(5) of
the Act in that it provides for the equitable allocation of reasonable
dues, fees and other charges among its Members and other persons using
its facilities and is not designed to unfairly discriminate between
customers, issuers, brokers, or dealers. As described more fully below
in the Exchange's statement regarding the burden on competition, the
Exchange believes that its transaction pricing is subject to
significant competitive forces, and that the proposed fees and rebates
described herein are appropriate to address such forces.

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

    The Exchange does not believe that the proposed change will impose
any burden on competition not necessary or appropriate in furtherance
of the purposes of the Act. The Exchange believes the proposed change
would encourage Members to maintain or increase their order flow to the
Exchange, thereby contributing to a deeper and more liquid market to
the benefit of all market participants and enhancing the attractiveness
of the Exchange as a trading venue. As a result, the Exchange believes
the proposal would enhance its competitiveness as a market that
attracts actionable orders, thereby making it a more desirable
destination venue for its customers. For these reasons, the Exchange
believes that the proposal furthers the Commission's goal in adopting
Regulation NMS of fostering competition among orders, which promotes
``more efficient pricing of individual stocks for all types of orders,
large and small.'' \14\
---------------------------------------------------------------------------

    \14\ See Securities Exchange Act Release No. 51808 (June 9,
2005), 70 FR 37496 (June 29, 2005).
---------------------------------------------------------------------------

Intramarket Competition
    The Exchange believes that the proposal would incentivize Members
to submit additional order flow, including liquidity-adding and
liquidity-removing orders designed to execute at the midpoint, to the
Exchange, thereby enhancing liquidity and market quality on the
Exchange to the benefit of all Members, as well as enhancing the
attractiveness of the Exchange as a trading venue, which the Exchange
believes, in turn, would continue to encourage market participants to
direct additional order flow to the Exchange. Greater liquidity
benefits all Members by providing more trading opportunities and
encourages Members to send additional orders to the Exchange, thereby
contributing to robust levels of liquidity, which benefits all market
participants. The proposed reduced fee for executions of Midpoint Peg
Orders that remove liquidity at the midpoint from the Exchange will
apply to all such executions for all Members on the Exchange. As such,
the Exchange believes the proposed changes would not impose any burden
on intramarket competition that is not necessary or appropriate in
furtherance of the purposes of the Act.
Intermarket Competition
    The Exchange believes its proposal will benefit competition, and
the Exchange notes that it operates in a highly competitive market.
Members have numerous alternative venues they may participate on and
direct their order flow to, including fifteen other equities exchanges
and numerous alternative trading systems and other off-exchange venues.
As noted above, no single registered equities exchange currently has
more than 17% of the total market share of executed volume of equities
trading.\15\ Thus, in such a low-concentrated and highly competitive
market, no single equities exchange possesses significant pricing power
in the execution of order flow. Moreover, the Exchange believes that
the ever-shifting market share among the exchanges from month to month
demonstrates that market participants can shift order flow in response
to new or different pricing structures being introduced to the market.
Accordingly, competitive forces constrain the Exchange's transaction
fees and rebates, including with respect to executions of Midpoint Peg
Orders, and market participants can readily choose to send their orders
to other exchanges and off-exchange venues if they deem fee levels at
those other venues to be more favorable.
---------------------------------------------------------------------------

    \15\ See supra note 5.
---------------------------------------------------------------------------

    As described above, the proposed changes represent a competitive
proposal through which the Exchange is seeking to encourage additional
order flow to the Exchange through a reduced fee for executions of
Midpoint Peg Orders. The proposed fee for executions of Midpoint Peg
Orders that remove liquidity at the midpoint from the Exchange is
competitive with fees charged by at least one other exchange that
offers a similar pricing incentive.\16\ Accordingly, the Exchange
believes its proposal would not burden, but rather promote, intermarket
competition by enabling it to better compete with other exchanges that
offer similar pricing incentives to market participants.
---------------------------------------------------------------------------

    \16\ See supra note 13.
---------------------------------------------------------------------------

    Additionally, the Commission has repeatedly expressed its
preference for competition over regulatory intervention in determining
prices, products, and services in the securities markets. Specifically,
in Regulation NMS, the Commission highlighted the importance of market
forces in determining prices and SRO revenues and, also, recognized
that current regulation of the market system ``has been remarkably
successful in promoting market competition in its broader forms that
are most important to investors and listed companies.'' \17\ The fact
that this market is competitive has also long been recognized by the
courts. In NetCoalition v. Securities and Exchange Commission, the D.C.
circuit stated: ``[n]o one disputes that competition for order flow is
`fierce.' . . . As the SEC explained, `[i]n the U.S. national market
system, buyers and sellers of securities, and the broker-dealers that
act as their routing agents, have a wide range of choices of where to
route orders for execution'; [and] `no exchange can afford to take its
market share percentages for granted' because `no exchange possess a
monopoly, regulatory or otherwise, in the execution of order flow from
broker dealers' . . .''.\18\ Accordingly, the Exchange does not believe
its proposed pricing changes impose any burden on competition that is
not necessary or appropriate in furtherance of the purposes of the Act.
---------------------------------------------------------------------------

    \17\ See Securities Exchange Act Release No. 51808 (June 9,
2005), 70 FR 37496, 37499 (June 29, 2005).
    \18\ NetCoalition v. SEC, 615 F.3d 525, 539 (D.C. Cir. 2010)
(quoting Securities Exchange Act Release No. 59039 (December 2,
2008), 73 FR 74770, 74782-83 (December 9, 2008) (SR-NYSE-2006-21)).
---------------------------------------------------------------------------

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

    The foregoing rule change has become effective pursuant to section
19(b)(3)(A)(ii) of the Act,\19\ and Rule

19b-4(f)(2) \20\ thereunder. 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.
---------------------------------------------------------------------------

    \19\ 15 U.S.C. 78s(b)(3)(A)(ii).
    \20\ 17 CFR 240.19b-4(f)(2).
---------------------------------------------------------------------------

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

    [squ] Use the Commission's internet comment form (http://www.sec.gov/rules/sro.shtml); or
    [squ] Send an email to [email protected]. Please include File
Number SR-PEARL-2022-53 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-PEARL-2022-53. 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 submissions. You should submit only information that
you wish to make available publicly.
    All submissions should refer to File Number SR-PEARL-2022-53 and
should be submitted on or before January 5, 2023. For the Commission,
by the Division of Trading and Markets, pursuant to delegated
authority.\21\
---------------------------------------------------------------------------

    \21\ 17 CFR 200.30-3(a)(12).

Sherry R. Haywood,
Assistant Secretary.
[FR Doc. 2022-27162 Filed 12-14-22; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 76, Number 183 (Wednesday, September 21, 2011)]
[Rules and Regulations]
[Pages 58398-58399]
[FR Doc No: 2011-24316]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Chapter I

[Docket No. FDA-2011-D-0633]

Revised Guidance on Marketed Unapproved Drugs; Compliance Policy
Guide Sec. 440.100; Marketed New Drugs Without Approved NDAs or ANDAs;
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of compliance policy guide.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a revised guidance entitled ``Marketed Unapproved
Drugs--Compliance Policy Guide Sec. 440.100, Marketed New Drugs Without
Approved NDAs or ANDAs'' (CPG 440.100). CPG 440.100 describes how FDA
intends to exercise its enforcement discretion with regard to drug
products marketed in the United States that do not have required FDA
approval for marketing. CPG 440.100 has been revised to state that the
enforcement priorities and potential exercise of enforcement discretion
discussed in the CPG apply only to unapproved new drug products that
are being commercially used or sold as of September 19, 2011. All
unapproved new drugs introduced onto the market after that date are
subject to immediate enforcement action at any time, without prior
notice and without regard to the enforcement priorities set forth in
CPG 440.100.

DATES: Submit either electronic or written comments on Agency guidances
at any time.

ADDRESSES: 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, 10903 New Hampshire Ave., Bldg.
51, rm. 2201, 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
guidance document.
    Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Sakineh Walther, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 5242, Silver Spring, MD 20993-0002, 301-
796-3349.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a revised guidance entitled
``Marketed Unapproved Drugs--Compliance Policy Guide Sec. 440.100,
Marketed New Drugs Without Approved NDAs or ANDAs''. This CPG is being
issued consistent with FDA's good guidance practices (GGP) regulation
(Sec.  10.115 (21 CFR 10.115)). This CPG is being implemented without
prior public comment because the Agency has determined that prior
public participation is not feasible or appropriate (Sec.
10.115(g)(2)). The Agency made this determination because, in light of
the fact that revised CPG 440.100 establishes the date after which the
enforcement priorities and potential exercise of enforcement discretion
discussed in it do not apply to newly introduced unapproved drugs,
delayed implementation of revised CPG 440.100 would provide an
incentive for manufacturers to rush new unapproved drugs to market
during the comment and finalization period, in order to be subject to
enforcement priorities that may be perceived as more advantageous to
extended marketing of illegal, unapproved drug products. The potential
increase in marketing of new unapproved drugs raises public health
concerns; because unapproved drug products have not been approved by
FDA for safety, effectiveness, and quality, patients may be at greater
risk when using unapproved drug products than when using FDA-approved
drug products. In light of the concerns about potential increased
marketing of new unapproved drugs, FDA has determined that it is not
appropriate to seek comment before implementing revised CPG 440.100.
Although CPG 440.100 is immediately in effect, it remains subject to
comment in accordance with the Agency's GGP regulation.
    Under the Federal Food, Drug, and Cosmetic Act, drug products that
require approval must obtain that approval prior to introduction into
interstate commerce (see 21 U.S.C. 355). Manufacturers and distributors
of products that enter the market without complying with these long-
standing statutory requirements are acting in violation of the law. In
June 2006, FDA announced a new drug safety initiative to remove
unapproved drugs from the market. As part of the Unapproved Drugs
Initiative, FDA issued a final CPG entitled ``Marketed Unapproved
Drugs--Compliance Policy Guide Sec. 440.100, Marketed New Drugs Without
Approved NDAs or ANDAs'' (CPG 440.100) (see 71 FR 33466, June 9, 2006).
CPG 440.100 describes how FDA intends to exercise its enforcement
discretion regarding currently marketed unapproved new drugs. CPG
440.100 describes six categories of unapproved drug products that are
the Agency's highest enforcement priorities, and the circumstances in
which the Agency intends to bring enforcement actions consistent with
those priorities. FDA has initiated 17 actions against unapproved new
drugs under the Unapproved Drugs Initiative and engaged in significant
outreach to manufacturers, distributors, consumers and prescribers
under this Initiative, resulting in the removal of over a thousand
unapproved new drugs from the market (see http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/SelectedEnforcementActionsonUnapprovedDrugs/ucm238675.htm).
    Despite both the long-standing statutory requirement that new drugs
must obtain approval prior to marketing (21 U.S.C. 355) and FDA's
outreach efforts under the Marketed Unapproved Drugs Initiative, FDA is
aware that unapproved new drugs have continued to come onto the market
after the issuance of the 2006 CPG. In some cases, these unapproved new
drugs come onto the market to compete with other unapproved new drugs
that are already on the market. In other cases, unapproved new drugs
are introduced to the market when a manufacturer perceives that there
may be an ``opportunity'' to gain a share of the market after actions
taken by FDA, including enforcement actions that remove similar
unapproved new drugs from the market. In either case, FDA must expend
additional scarce resources to address unapproved products in
situations where manufacturers and distributors have had ample notice
that the products they are introducing onto

the market cannot be legally marketed without approval.
    To address this situation, FDA is revising CPG 440.100 to make
clear that unapproved new drugs introduced onto the market after
September 19, 2011 are subject to enforcement action at any time,
without prior notice and without regard to the enforcement priorities
set forth in CPG 440.100 for unapproved new drugs marketed prior to
September 19, 2011. The revision to CPG 440.100 excludes from the
enforcement priorities set forth in the guidance the manufacture and
marketing of newly introduced unapproved drugs.
    This guidance represents the Agency's current thinking on its
enforcement priorities with respect to new drugs marketed without
approved new drug applications or abbreviated new drug applications. It
does not create or confer any rights for or on any person and does not
operate to bind FDA or the public. An alternative approach may be used
if such approach satisfies the requirements of the applicable statutes
and regulations.

II. Comments

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

III. Electronic Access

    Persons with access to the Internet may obtain the document at
either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.

    Dated: September 16, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
 [FR Doc. 2011-24316 Filed 9-19-11; 12:30 pm]
BILLING CODE 4160-01-P


MEASURE DATA STANDARD Standard No.: 1 XXX Version 1   FINAL DRAFT July 26, 2005 This standard has been produced through the Environmental Data Standards Council ( EDSC).

The Environmental Data Standards Council ( EDSC) is a partnership among EPA, States and Tribal partners to develop and agree upon data standards for environmental information collection and exchange. More information about the EDSC is available at http:// www. envdatastandards. net. Measure Data Standard Std No.: 1 XXX Version 1.0   Final Draft July 26, 2005 Page 2 Foreword The Environmental Data Standards Council identifies, prioritizes and pursues the creation of data standards for those areas where information exchange standards will provide the most value in achieving environmental results. The Council involves Tribes and Tribal Nations, state and federal agencies in the development of the standards and then provides the draft materials for general review. Business groups, non governmental organizations, and other interested parties may then provide input and comment for Council consideration and standard finalization. Draft and final standards are available at http:// www. envdatastandards. net.

1.0 INTRODUCTION This Measure Data Standard focuses on data elements used to identify and describe recorded measurements or analytical results that are being exchanged between data trading partners. There are many categories or types of measurement where the units in each type are mutually comparable. For example, lengths, diameters, distances, heights, wavelengths constitute such a category. Mutually comparable quantities are called " quantities of the same kind". Each category of measurement has an allowed set of units of measure. Two or more physical quantities cannot be compared unless they belong to the same category of measurements. Some example categories of measurements include: length, mass, time, temperature, amount of substance, velocity, force, relative density, illuminance, and entropy.

1.1 Scope This data standard provides and describes data groupings that are used to exchange data about recorded measurement or analytical results.

1.2 References to Other Data Standards None 1.3 Terms and Definitions For the purposes of this document, the following terms and definitions apply.

Term Definition Measure A set of data elements that may be utilized for recording the measurement of observations or analytical results.

1.4 Implementation Users are encouraged to use the XML registry housed on the Exchange Network Web site to download schema components for the construction of XML schema flows ( http:// www. exchangenetwork. net).

1.5 Document Structure The structure of this document is briefly described below: a. Section 2.0 Measure Data Standard Diagram, illustrates the principal data groupings contained within this standard. b. Section 3.0 Measure Data Standard Table, provides information on the high level, intermediate and elemental Measure data groupings. Where applicable, for each level of this data standard a definition, XML tag, note( s), example list of values and format are provided. The format column may include the required number of characters for the associated data element, where " A" specifies alphanumeric and " N" designates numeric. Measure Data Standard Std No.: 1 XXX Version 1.0   Final Draft July 26, 2005 Page 3 c. Data Standard Numbering: For purposes of clarity and to enhance understanding of data standard hierarchy and relationships, each data group is numerically classified from the primary to the elemental level. d. Code metadata: Based on the business need, additional metadata may be required to sufficiently describe a code. A note regarding this additional metadata is included in the notes column for code elements. Additional metadata for codes may include:   Code List Identifier, which is a standardized reference to the context or source of the set of codes   Code List Version Identifier, which identifies the particular version of the set of codes.   Code List Version Agency Identifier, which identifies the agency responsible for maintaining the set of codes   Code List Name, which describes the corresponding name for which the code represents e. Appendix A, Measure Data Standard Structure Diagram illustrates the hierarchical classification of the Measure Data standard. This diagram enables business and technical users of this standard to quickly understand its general content and complexity. Measure Data Standard Std No.: 1 XXX Version 1.0   Final Draft July 26, 2005 Page 4 2.0 MEASURE DATA STANDARD DIAGRAM This diagram specifies the major data groups that may be used to identify the characteristics of a measure.

Measure Data Standard 1.0 Measure 2.0 Measure QA/ QC Measure Data Standard Std No.: 1 XXX Version 1.0   Final Draft July 26, 2005 Page 5 3.0 MEASURE DATA STANDARDS TABLE 1.0 Measure Definition: Identifies the value and the associated units of measure for measuring an observation or analytical result value.

Relationship: None.

Notes: None.

XML Tag: Measure Data Element Name Data Element Definitions Notes Format XML Tags 1.1 Measure Value The recorded dimension, capacity,

quality, or amount of something ascertained by measuring or observing. Example List of Values:

  0.001   < 15   ND   Present or Absent A MeasureValue 1.2 Measure Unit Code The code that represents the unit for measuring the item. Example List of Values:

  mg/ L   km Based on the business need, additional metadata may be required to sufficiently describe a code. This additional metadata is listed in the Introduction section, 1.5. d,

above. A MeasureUnitCode 1.3 Measure Qualifier Code A code used to identify any qualifying issues that affect the results. Examples:

  B   J   EST There may be multiple entries.

Based on the business need, additional metadata may be required to sufficiently describe a code. This additional metadata is listed in the Introduction section, 1.5. d,

above. A MeasureQualifier Code Measure Data Standard Std No.: 1 XXX Version 1.0   Final Draft July 26, 2005 Page 6 2.0 Measure QA/ QC Definition: The quality aspects of the measured value.

Relationship: None.

Notes: The following items could be expected to define the quality information needed:

  Precision   Confidence interval This is an optional set of data elements that specify the quality of a measurement. Refer to Quality Assurance and Quality Control [ DRAFT] Data Standard.

XML Tag: MeasureQAQC Measure Data Standard Std No.: 1 XXX Version 1.0   Final Draft July 26, 2005 Page 7 Appendix A Measure Data Standard Structure Diagram Measure Data Standard 1.0 Measure 1.1 Measure Value 1.2 Measure Unit Code 1.3 Measure Qualifier Code 2.0 Measure QA/ QC


[Federal Register Volume 76, Number 159 (Wednesday, August 17, 2011)]
[Notices]
[Pages 51020-51021]
[FR Doc No: 2011-20890]

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

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: EC11-103-000.
    Applicants: Duke Energy Ohio, Inc., Duke Energy Commercial Asset
Management.
    Description: Application of Duke Energy Ohio, Inc., et al.
    Filed Date: 08/08/2011.
    Accession Number: 20110808-5157.
    Comment Date: 5 p.m. Eastern Time on Monday, August 29, 2011.

    Take notice that the Commission received the following electric
rate filings:

    Docket Numbers: ER10-1777-003; ER10-2983-002; ER10-2980-002; ER10-
2988-003.
    Applicants: Thompson River Power, LLC, Castleton Power, LLC,
Sundevil Power Holdings, LLC, Castleton Energy Services, LLC.
    Description: Notification of Change in Status of Sundevil Power
Holdings, LLC, et al.
    Filed Date: 08/08/2011.
    Accession Number: 20110808-5155.
    Comment Date: 5 p.m. Eastern Time on Monday, August 29, 2011.

    Docket Numbers: ER11-2051-001.
    Applicants: Pure Energy Inc.
    Description: Pure Energy Inc. submits tariff filing per 35: Order
697 Compliance Filing to be effective 11/9/2010.
    Filed Date: 08/08/2011.
    Accession Number: 20110808-5035.
    Comment Date: 5 p.m. Eastern Time on Monday, August 29, 2011.

    Docket Numbers: ER11-4248-000.
    Applicants: Midwest Independent Transmission System Operator, Inc.,
ITC Midwest LLC.
    Description: Midwest Independent Transmission System Operator, Inc.
submits tariff filing per 35.13(a)(2)(iii: Filing of Notice of
Succession to be effective 10/8/2011.
    Filed Date: 08/08/2011.
    Accession Number: 20110808-5015.
    Comment Date: 5 p.m. Eastern Time on Monday, August 29, 2011.

    Docket Numbers: ER11-4249-000.
    Applicants: Midwest Independent Transmission System Operator, Inc.,
ITC Midwest LLC.
    Description: Midwest Independent Transmission System Operator, Inc.
submits tariff filing per 35.13(a)(2)(iii: Filing of Notice of
Succession to be effective 10/8/2011.
    Filed Date: 08/08/2011.
    Accession Number: 20110808-5017.
    Comment Date: 5 p.m. Eastern Time on Monday, August 29, 2011.

    Docket Numbers: ER11-4250-000.
    Applicants: Midwest Independent Transmission System Operator, Inc.,
ITC Midwest LLC.
    Description: Midwest Independent Transmission System Operator, Inc.
submits tariff filing per 35.13(a)(2)(iii: Filing of Notice of
Succession to be effective 10/8/2011.
    Filed Date: 08/08/2011.
    Accession Number: 20110808-5018.
    Comment Date: 5 p.m. Eastern Time on Monday, August 29, 2011.

    Docket Numbers: ER11-4251-000.
    Applicants: Midwest Independent Transmission System Operator, Inc.,
ITC Midwest LLC.
    Description: Midwest Independent Transmission System Operator, Inc.
submits tariff filing per 35.13(a)(2)(iii: Filing of Notice of
Succession to be effective 10/8/2011.

    Filed Date: 08/08/2011.
    Accession Number: 20110808-5020.
    Comment Date: 5 p.m. Eastern Time on Monday, August 29, 2011.

    Docket Numbers: ER11-4252-000.
    Applicants: Midwest Independent Transmission System Operator, Inc.,
ITC Midwest LLC.
    Description: Midwest Independent Transmission System Operator, Inc.
submits tariff filing per 35.13(a)(2)(iii: Filing of Notice of
Succession to be effective 10/8/2011.
    Filed Date: 08/08/2011.
    Accession Number: 20110808-5024.
    Comment Date: 5 p.m. Eastern Time on Monday, August 29, 2011.

    Docket Numbers: ER11-4253-000.
    Applicants: Wolverine Power Supply Cooperative, Inc.
    Description: Wolverine Power Supply Cooperative, Inc. submits
tariff filing per 35.13(a)(2)(iii: Certificates of Concurrence for Pere
Marquette, Sternberg & Vestaburg IFAs to be effective 4/21/2011.
    Filed Date: 08/08/2011.
    Accession Number: 20110808-5030.
    Comment Date: 5 p.m. Eastern Time on Monday, August 29, 2011.

    Docket Numbers: ER11-4254-000.
    Applicants: New England Power Company.
    Description: New England Power Company submits tariff filing per
35.13(a)(2)(iii: Interconnection Agreement with Lowell Cogeneration to
be effective 10/1/2011.
    Filed Date: 08/08/2011.
    Accession Number: 20110808-5093.
    Comment Date: 5 p.m. Eastern Time on Monday, August 29, 2011.

    Docket Numbers: ER11-4255-000.
    Applicants: Southern California Edison Company.
    Description: Southern California Edison Company submits tariff
filing per 35.13(a)(2)(iii: LGIA North Sky River Wind Project--North
Sky River Energy LLC to be effective 8/9/2011.
    Filed Date: 08/08/2011.
    Accession Number: 20110808-5126.
    Comment Date: 5 p.m. Eastern Time on Monday, August 29, 2011.

    Docket Numbers: ER11-4256-000.
    Applicants: Southern California Edison Company.
    Description: Southern California Edison Company submits tariff
filing per 35.13(a)(2)(iii: LGIA Amendment to Walnut Creek Energy Park
Project to be effective 8/9/2011.
    Filed Date: 08/08/2011.
    Accession Number: 20110808-5144.
    Comment Date: 5 p.m. Eastern Time on Monday, August 29, 2011.

    Docket Numbers: ER11-4257-000.
    Applicants: New York Independent System Operator, Inc.
    Description: New York Independent System Operator, Inc. submits
tariff filing per 35.13(a)(2)(iii: NYISO Tariff Revisions re: Bidding,
Scheduling, Settlement of Ancillary Services to be effective 10/7/2011.
    Filed Date: 08/08/2011.
    Accession Number: 20110808-5146.
    Comment Date: 5 p.m. Eastern Time on Monday, August 29, 2011.

    Docket Numbers: ER11-4258-000.
    Applicants: Desert View Power, Inc.
    Description:Desert View Power, Inc. submits tariff filing per
35.13(a)(2)(iii: Notice of Succession to be effective 10/7/2011.
    Filed Date: 08/08/2011.
    Accession Number: 20110808-5163.
    Comment Date: 5 p.m. Eastern Time on Monday, August 29, 2011.

    Docket Numbers: ER11-4259-000.
    Applicants: Midwest Independent Transmission System Operator, Inc.,
ITC Midwest LLC.
    Description: Midwest Independent Transmission System Operator, Inc.
submits tariff filing per 35.13(a)(2)(iii: Notice of Succession to
Interconnection Agreement to be effective 10/8/2011.
    Filed Date: 08/08/2011.
    Accession Number: 20110808-5190.
    Comment Date: 5 p.m. Eastern Time on Monday, August 29, 2011.

    Docket Numbers: ER11-4260-000.
    Applicants: Elk Hills Power, LLC.
    Description: Elk Hills Power, LLC submits tariff filing per
35.13(a)(2)(iii: Notice of Category 1 Seller Status and Revised Market-
Based Rate Tariff to be effective 8/9/2011.
    Filed Date: 08/08/2011.
    Accession Number: 20110808-5191.
    Comment Date: 5 p.m. Eastern Time on Monday, August 29, 2011.

    Docket Numbers: ER11-4261-000.
    Applicants: Midwest Independent Transmission System Operator, Inc.,
ITC Midwest LLC.
    Description: Midwest Independent Transmission System Operator, Inc.
submits tariff filing per 35.13(a)(2)(iii: Notice of Succession for
Interconnection Agreement to be effective 10/8/2011.
    Filed Date: 08/08/2011.
    Accession Number: 20110808-5192.
    Comment Date: 5 p.m. Eastern Time on Monday, August 29, 2011.

    Docket Numbers: ER11-4262-000.
    Applicants: Puget Sound Energy, Inc.
    Description: Puget Sound Energy, Inc. submits tariff filing per
35.1: Residential Purchase and Sale Agreement to be effective 10/1/
2011.
    Filed Date: 08/08/2011.
    Accession Number: 20110808-5193.
    Comment Date: 5 p.m. Eastern Time on Monday, August 29, 2011.

    Docket Numbers: ER11-4263-000.
    Applicants: Midwest Independent Transmission System Operator, Inc.,
ITC Midwest LLC.
    Description: Midwest Independent Transmission System Operator, Inc.
submits tariff filing per 35.13(a)(2)(iii: Filing of Notice of
Succession to be effective 10/8/2011.
    Filed Date: 08/08/2011.
    Accession Number: 20110808-5194.
    Comment Date: 5 p.m. Eastern Time on Monday, August 29, 2011.

    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
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: August 9, 2011.
Kimberly D. Bose,
Secretary.
[FR Doc. 2011-20890 Filed 8-16-11; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 83, Number 94 (Tuesday, May 15, 2018)]
[Notices]
[Pages 22539-22541]
[FR Doc No: 2018-10253]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-83193; File No. SR-NASDAQ-2018-036]

Self-Regulatory Organizations; The Nasdaq Stock Market LLC;
Notice of Filing and Immediate Effectiveness of a Proposed Rule Change
To Reorganize and Amend The Nasdaq Options Market LLC Chapter XV,
Section 3, Entitled ``Nasdaq Options Market--Ports and Other Services

May 9, 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 April 27, 2018, The Nasdaq Stock Market LLC (``Nasdaq'' or
``Exchange'') filed with the Securities and Exchange Commission
(``Commission'') the 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.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
---------------------------------------------------------------------------

I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to reorganize and amend The Nasdaq Options
Market LLC (``NOM'') Chapter XV, Section 3, entitled ``Nasdaq Options
Market--Ports and Other Services.''
    The text of the proposed rule change is available on the Exchange's
website at http://nasdaq.cchwallstreet.com, at the principal office of
the Exchange, and at the Commission's Public Reference Room.

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

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

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

1. Purpose
    The Exchange proposes to reorganize and amend Chapter XV, Section
3, entitled ``Nasdaq Options Market--Ports and Other Services.'' The
Exchange offers various services across its 6 affiliated options
markets, NOM, Nasdaq BX, Inc., Nasdaq Phlx LLC, Nasdaq ISE, LLC, Nasdaq
GEMX, LLC and Nasdaq MRX, LLC (``Nasdaq Affiliated Markets'').\3\ The
Exchange desires to rename services to conform the naming of the
offerings across all Nasdaq Affiliated Markets. The Exchange proposes
to reorganize Section 3 to list order and quote protocols first, order
and execution offerings next, followed by data ports and other ports as
the last section. The Exchange proposes to list data offerings which
are offered at no cost. The Exchange is also proposing to remove
obsolete pricing. The Exchange believes that aligning its offerings,
where relevant, across the Nasdaq Affiliated Markets will provide more
transparency as to the offerings for market participants.
---------------------------------------------------------------------------

    \3\ The Exchange will file a similar rule change on each Nasdaq
Affiliated Market to conform the offerings by amending naming to
make them similar and delineating each offering on the fee schedule
where no fee is assessed.
---------------------------------------------------------------------------

Ports
    The Exchange proposes to define a port within Section 3 to provide
additional clarity to the fee schedule as ``a logical connection or
session that enables a market participant to send inbound messages and/
or receive outbound messages from the Exchange using various
communication protocols.'' The Exchange believes this definition will
assist Participants in distinguishing ports from other offerings.
Order and Quote Protocols
    The Exchange proposes to add a new section (i) and include the
following introductory sentence, ``The following order and quote
protocols are available on NOM.''
    Today, NOM offers market participants an Order Entry order protocol
and an SQF quote protocol. These fees currently exist on the fee
schedule. The Exchange is not amending any pricing related to these
protocols. The Exchange proposes to rename ``Order Entry Port Fee'' as
``FIX Port Fee.'' This description is more accurate as ``FIX'' is the
name of the

order entry protocol. Nasdaq ISE LLC uses the terminology ``FIX''
within its fee schedule.\4\ A Participant may request an SQF Port or an
SQF Purge Port, the pricing is the same for these ports.\5\ SQF is an
interface that allows market makers to connect and send quotes, sweeps
and auction responses into the Exchange. The SQF Purge port only
receives and notifies of purge requests from the market maker. The
proposal is to include a line item for each offering because a
Participant may either select an SQF port or an SQF Purge Port. The
price does not vary. The Exchange separately lists these offerings on
Nasdaq ISE, LLC. A separate line item will make clear that there are
two options for this offering. The pricing for these ports is not being
amended.
---------------------------------------------------------------------------

    \4\ See ISE fee schedule at Chapter V, D.
    \5\ Pricing is incremental for these ports. Pricing is based on
the number of ports that a Participant has subscribed to in a given
month.
---------------------------------------------------------------------------

    The Exchange believes that grouping the available order and quote
protocols together into their own subsection will provide greater
transparency within its fee schedule as to the available protocols.
Order and Execution Information
    The Exchange proposes to add a new section (ii) and add the
following introductory sentence, ``The following order and execution
information is available to Participants.'' The Exchange proposes to
group the available order and execution information that is particular
to a Participant's executions on NOM into its own subsection. Today,
NOM offers CTI, Order Entry DROP, TradeInfo and OTTO DROP. The Exchange
proposes to rename ``Order Entry DROP'' as ``FIX DROP'' for the reasons
described above. Nasdaq ISE, LLC uses the term FIX DROP. The Exchange
proposes to rename ``TradeInfo'' as ``NOM TradeInfo Interface'' to make
clear that this particular offering is an interface. The Exchange
proposes to relocate these current fees into section (ii). No changes
are being made to pricing and these fees exist today within Section 3.
Data Ports
    The Exchange proposes to add a new section (iii) and include the
following information, ``The following data ports fees apply in
connection with data subscriptions pursuant to NOM Rules at Chapter XV,
Section 4. The below port fees do not apply if the subscription is
delivered via multicast.'' The following sentence is simply being
relocated, ``These ports are available to non-NOM Participants and NOM
Participants.'' The Exchange believes the addition of these sentences
makes clear where the related applicable data fees can be located and
when the fees for ports are charged. The Exchange notes that if the
subscription is delivered via multicast, the port fee is not charged.
There are multiple ways in which data can be communicated. Multicast
refers to sending data across a network to several users as [sic] a
time. Unicast on the other hand sends data across a network to a single
recipient. Finally, TCP, which stands for Transmission Control Protocol
and is also known as ``TCP/IP'' refers to the suite which includes the
internet Protocol, provides host-to-host connectivity. Today, the
Exchange requires a port when a Participant utilizes Unicast and TCP/IP
delivery, but does not require a port when a Participant selects
multicast delivery. The Exchange believes this additional information
will add more transparency to the fee schedule for Participants
selecting data transmission options. The Exchange notes the current
offerings for NOM, ITTO and BONO, are being relocated within this
section. No changes are being made to the fees.
Other Ports
    The Exchange proposes to adopt a new section (iv) entitled ``Other
Ports'' to include Disaster Recovery Ports. Today, the Exchange offers
Disaster Recovery Ports for all ports reorganized into proposed
subsections (i), (ii) and (iii). The Exchange is noting that these
ports are available at no cost to make clear their availability.
ITTO Wave Ports
    Today, the Exchange offers Remote ITCH to Trade Options (ITTO) Wave
Ports. These ports are subject to a 30-day testing period during which
the recurring monthly fees are waived, and a one-year minimum purchase
period that begins at the conclusion of the 30-day testing period at
the below rates:

------------------------------------------------------------------------
                                           Installation      Recurring
                Location                        fee         monthly fee
------------------------------------------------------------------------
Secaucus................................          $2,500          $7,500
Mahwah..................................           5,000          10,000
------------------------------------------------------------------------

    NOM no longer offers these ITTO Wave Ports to its Participants. The
Exchange proposes to eliminate these fees from the fee schedule.
2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with Section 6(b) of the Securities Exchange Act of 1934,\6\ in
general, and furthers the objectives of Section 6(b)(5) of the Act,\7\
in particular, in that it is designed to promote just and equitable
principles of trade, to remove impediments to and perfect the mechanism
for a free and open market and a national market system, and, in
general, to protect investors and the public interest, by providing
greater transparency as to the order and execution information offered
on NOM. The Exchange's proposal to reorganize Section 3 and rename
certain offerings to conform to other Nasdaq Affiliated Markets will
provide clarity as to the offerings and uniformity in naming similar
offerings. The Exchange believes that its new structure makes clear the
differences in its offerings and the availability of various options
within each type of offering. The Exchange's proposal is consistent
with the protection of investors and the public interest in that the
proposal provides greater transparency as to the offerings, the
application of fees and the availability of offerings which are offered
at no cost. The Exchange's proposal to define a port should also
provide market participants with greater insight into the terminology
utilized within Section 3.
---------------------------------------------------------------------------

    \6\ 15 U.S.C. 78f(b).
    \7\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

    Finally, the Exchange's proposal to eliminate ITTO Wave Ports is
consistent with the Act because these ports are no longer offered to
any Participant and removing the fees will eliminate confusion as to
the Exchange's current offering.

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

    In accordance with Section 6(b)(8) of the Act,\8\ the Exchange does
not believe that the proposed rule change will

impose any burden on intermarket or intra-market competition that is
not necessary or appropriate in furtherance of the purposes of the Act.
The Exchange's proposal does not impose an undue burden on competition,
rather the Exchange is seeking to provide greater transparency within
its rules with respect to the various order and execution information
offered on NOM. The offerings are available to all Participants. The
Exchange does not intend to amend pricing, rather it proposes to make
clear the application of the current pricing.
---------------------------------------------------------------------------

    \8\ 15 U.S.C. 78f(b)(8).
---------------------------------------------------------------------------

    With respect to the ITTO Wave Ports, no Participant utilizes these
services today. Eliminating these fees will avoid confusion as to the
Exchange's current offerings.

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

    Because the 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 from the date on which it was filed, or such shorter time as the
Commission may designate if consistent with the protection of investors
and the public interest, the proposed rule change has become effective
pursuant to Section 19(b)(3)(A) of the Act \9\ and Rule 19b-4(f)(6)
thereunder.\10\
---------------------------------------------------------------------------

    \9\ 15 U.S.C. 78s(b)(3)(A).
    \10\ 17 CFR 240.19b-4(f)(6). In addition, Rule 19b-4(f)(6)(iii)
requires the Exchange to give the Commission written notice of the
Exchange's intent to file the proposed rule change, along with a
brief description and text of 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 under Rule 19b-4(f)(6) \11\ normally
does not become operative for 30 days after the date of filing.
However, pursuant to Rule 19b-4(f)(6)(iii),\12\ the Commission may
designate a shorter time if such action is consistent with the
protection of investors and the public interest. The Exchange has asked
the Commission to waive the 30-day operative delay so that the proposal
may become operative immediately upon filing. The Exchange states that
such waiver will allow it to update its rules immediately to provide
more detailed and reorganized information regarding its offerings and
further the protection of investors and the public interest because it
will provide greater transparency as to the offerings available to
members. For this reason, the Commission believes that waiving the 30-
day operative delay is consistent with the protection of investors and
the public interest and, therefore, the Commission designates the
proposed rule change to be operative upon filing.\13\
---------------------------------------------------------------------------

    \11\ 17 CFR 240.19b-4(f)(6).
    \12\ 17 CFR 240.19b-4(f)(6)(iii).
    \13\ 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 protected]. Please include
File Number SR-NASDAQ-2018-036 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-NASDAQ-2018-036. 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-NASDAQ-2018-036, and should be submitted
on or before June 5, 2018.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\14\
---------------------------------------------------------------------------

    \14\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Eduardo A. Aleman,
Assistant Secretary.
[FR Doc. 2018-10253 Filed 5-14-18; 8:45 am]
 BILLING CODE 8011-01-P